42 U.S. Code CHAPTER 6A—PUBLIC HEALTH SERVICE

§ 193

TITLE 42—THE PUBLIC HEALTH AND WELFARE

dent, by and with the advice and consent of the
Senate. The said bureau shall investigate and
report to the Secretary of Health and Human
Services, upon all matters pertaining to the welfare of children and child life among all classes
of our people, and shall especially investigate
the questions of infant mortality, the birth rate,
orphanage, juvenile courts, desertion, dangerous
occupations, accidents and diseases of children,
employment, legislation affecting children in
the several States and Territories. But no official, or agent, or representative of said bureau
shall, over the objection of the head of the family, enter any house used exclusively as a family
residence. The chief of said bureau may from
time to time publish the results of these investigations in such manner and to such extent as
may be prescribed by the Secretary.
(Apr. 9, 1912, ch. 73, § 2, 37 Stat. 79; Mar. 4, 1913,
ch. 141, §§ 3, 6, 37 Stat. 737, 738; 1946 Reorg. Plan
No. 2, § 1, eff. July 16, 1946, 11 F.R. 7873, 60 Stat.
1095; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title
V, § 509(b), Oct. 17, 1979, 93 Stat. 695.)
CODIFICATION
In the first sentence of this section, provisions which
specified an annual compensation of $5,000 for the chief
of the Childrens Bureau have been omitted superseded.
Following enactment of the Classification Act of 1923,
the compensation was fixed in accordance with that
Act. See act Feb. 27, 1925, title IV, 43 Stat. 1050. Sections 1202 and 1204 of the Classification Act of 1949, 63
Stat. 972, 973, repealed the Classification Act of 1923 and
all other laws or parts of laws inconsistent with the
1949 Act. The Classification Act of 1949 was repealed by
Pub. L. 89–554, Sept. 6, 1966, § 8(a), 80 Stat. 632, and reenacted as chapter 51 and subchapter III of chapter 53 of
Title 5, Government Organization and Employees. Section 5102 of Title 5 now contains the applicability provisions of the 1949 Act, and section 5103 of Title 5 authorizes the Office of Personnel Management to determine
the applicability to specific positions and employees.
Section was formerly classified to section 18a of Title
29, Labor.

Page 14

No. 2, § 1, eff. July 16, 1946, 11 F.R. 7873, 60 Stat.
1095; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title
V, § 509(b), Oct. 17, 1979, 93 Stat. 695.)
CODIFICATION
Section 3 of act Apr. 9, 1912, also provided for compensation of assistant chief and for appointment and
compensation of other employees of the bureau.
Section was formerly classified to section 18b of Title
29, Labor.
TRANSFER OF FUNCTIONS
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out in as a
note under section 3501 of this title. Federal Security
Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953. Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human
Services by section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20, Education.
‘‘Federal Security Administrator’’ substituted for
‘‘Secretary of Labor’’ pursuant to Reorg. Plan No. 2 of
1946. See note set out under section 191 of this title.
‘‘Secretary of Labor’’ substituted for ‘‘Secretary of
Commerce and Labor’’ pursuant to act Mar. 4, 1913. See
note set out under section 191 of this title.

§ 194. Quarters for bureau
The Secretary of Health and Human Services
is directed to furnish sufficient quarters for the
work of this bureau at an annual rental not to
exceed $2,000.
(Apr. 9, 1912, ch. 73, § 4, 37 Stat. 80; Mar. 4, 1913,
ch. 141, § 3, 37 Stat. 737; 1946 Reorg. Plan No. 2,
§ 1, eff. July 16, 1946, 11 F.R. 7873, 60 Stat. 1095;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695.)
CODIFICATION
Section was formerly classified to section 18c of Title
29, Labor.

TRANSFER OF FUNCTIONS

TRANSFER OF FUNCTIONS

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
‘‘Federal Security Administrator’’ substituted for
‘‘said department’’ and for ‘‘Secretary of Labor’’ pursuant to Reorg. Plan No. 2 of 1946. See note set out under
section 191 of this title.
‘‘Secretary of Labor’’ substituted for ‘‘Secretary of
Commerce and Labor’’ pursuant to act Mar. 4, 1913. See
note set out under section 191 of this title.

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
‘‘Federal Security Administrator’’ substituted for
‘‘Secretary of Labor’’ pursuant to Reorg. Plan No. 2 of
1946. See note set out under section 191 of this title.
‘‘Secretary of Labor’’ substituted for ‘‘Secretary of
Commerce and Labor’’ pursuant to act Mar. 4, 1913. See
note set out under section 191 of this title.

§ 193. Assistant chief
There shall be in the Children’s Bureau, until
otherwise provided for by law, an assistant
chief, to be appointed by the Secretary of Health
and Human Services.
(Apr. 9, 1912, ch. 73, § 3, 37 Stat. 80; Mar. 4, 1913,
ch. 141, §§ 3, 6, 37 Stat. 737, 738; 1946 Reorg. Plan

CHAPTER 6A—PUBLIC HEALTH SERVICE
SUBCHAPTER I—ADMINISTRATION AND
MISCELLANEOUS PROVISIONS
Sec.

201.

Definitions.

202.

Administration and supervision of Service.

PART A—ADMINISTRATION

Page 15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

203.
204.
204a.
205.
206.
207.
208.
209.
209a to 209c.
209d.
210.
210–1.
210a.
210b.
211.
211a, 211b.
211c.
212.
212a, 212b.
213.
213a.

214.
214a.
215.
216.
217.
217a.
217a–1.
217b.
218.
218a.
219 to 230.
231.
232.
233.
234.
235.
236.
237.
237a.

Organization of Service.
Commissioned Corps and Ready Reserve
Corps.
Deployment readiness.
Appointment and tenure of office of Surgeon General; reversion in rank.
Assignment of officers.
Grades, ranks, and titles of commissioned corps.
Repealed.
Appointment of personnel.
Omitted or Repealed.
Appointment of osteopaths as commissioned officers.
Pay and allowances.
Annual and sick leave.
Repealed.
Professional categories.
Promotion of commissioned officers.
Repealed.
Promotion credit for medical officers in
assistant grade.
Retirement of commissioned officers.
Repealed.
Military benefits.
Rights, benefits, privileges, and immunities for commissioned officers or beneficiaries; exercise of authority by Secretary or designee.
Presentation of United States flag upon
retirement.
Repealed.
Detail of Service personnel.
Regulations.
Use of Service in time of war or emergency.
Advisory councils or committees.
Advisory committees; prohibition of consideration of political affiliations.
Volunteer services.
National Advisory Councils on Migrant
Health.
Training of officers.
Transferred, Repealed, or Omitted.
Service and supply fund; uses; reimbursement.
National Institute of Mental Health; authorization of appropriation; construction; location.
Civil actions or proceedings against commissioned officers or employees.
Repealed.
Administration of grants in multigrant
projects; promulgation of regulations.
Orphan Products Board.
Silvio O. Conte Senior Biomedical Research Service.
Health and Human Services Office on
Women’s Health.

PART B—MISCELLANEOUS PROVISIONS
238.
238a.
238b.
238c.
238d.
238e.
238f.
238g.
238h.
238i.
238j.
238k.
238l.
238m.
238n.

Gifts for benefit of Service.
Use of immigration station hospitals.
Disposition of money collected for care
of patients.
Transportation of remains of officers.
Availability of appropriations for grants
to Federal institutions.
Transfer of funds.
Availability of appropriations.
Wearing of uniforms.
Biennial report.
Memorials and other acknowledgments
for contributions to health of Nation.
Evaluation of programs.
Contract authority.
Recovery.
Use of fiscal agents.
Abortion-related discrimination in governmental activities regarding training and licensing of physicians.

238o.

Restriction on use of funds for assisted
suicide, euthanasia, and mercy killing.
Recommendations and guidelines regarding automated external defibrillators
for Federal buildings.
Liability regarding emergency use of
automated external defibrillators.

238p.

238q.

PART C—SMALLPOX EMERGENCY PERSONNEL
PROTECTION
239.
239a.

General provisions.
Determination of eligibility and benefits.
Smallpox vaccine injury table.
Medical benefits.
Compensation for lost employment income.
Payment for death.
Administration.
Authorization of appropriations.
Relationship to other laws.

239b.
239c.
239d.
239e.
239f.
239g.
239h.

PART D—UNITED STATES PUBLIC HEALTH SCIENCES
TRACK
239l.
Establishment.
239l–1.
Administration.
239l–2.
Students; selection; obligation.
239l–3.
Funding.
SUBCHAPTER II—GENERAL POWERS AND DUTIES
PART A—RESEARCH AND INVESTIGATIONS
241.
242.

242a.
242b.

242c to 242j.
242k.
242l.
242m.

242n.
242o.
242p.
242q.
242q–1.
242q–2.
242q–3.
242q–4.
242q–5.
242r.
242s.

Research and investigations generally.
Studies and investigations on use and
misuse of narcotic drugs and other
drugs; annual report to Attorney General; cooperation with States.
Repealed.
General authority respecting research,
evaluations, and demonstrations in
health statistics, health services, and
health care technology.
Repealed or Transferred.
National Center for Health Statistics.
International cooperation.
General provisions respecting effectiveness, efficiency, and quality of health
services.
Repealed.
Health conferences; publication of health
educational information.
National disease prevention data profile.
Task Force on Aging Research; establishment and duties.
Membership.
Administrative staff and support.
Repealed.
Definitions.
Authorization of appropriations.
Improvement and publication of data on
food-related allergic responses.
Centers for Disease Control and Prevention Office of Women’s Health.

PART B—FEDERAL-STATE COOPERATION
243.
244.
244–1, 244a.
245.
245a.
246.
246a.

247.
247a.

General grant of authority for cooperation.
Public access defibrillation programs.
Repealed.
Public access defibrillation demonstration projects.
Repealed.
Grants and services to States.
Bureau of State Services management
fund; establishment; advancements;
availability.
Omitted.
Family support groups for Alzheimer’s
disease patients.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Sec.

247b.

247d–6b.

Project grants for preventive health
services.
247b–1.
Screenings, referrals, and education regarding lead poisoning.
247b–2.
Repealed.
247b–3.
Education, technology assessment, and
epidemiology regarding lead poisoning.
247b–3a.
Training and reports by the Health Resources and Services Administration.
247b–4.
National Center on Birth Defects and Developmental Disabilities.
247b–4a.
Early detection, diagnosis, and interventions for newborns and infants with
hearing loss.
247b–4b to 247b–4e. Repealed.
247b–4f.
Research relating to preterm labor and
delivery and the care, treatment, and
outcomes of preterm and low birthweight infants.
247b–4g.
Interagency Coordinating Council on
Prematurity and Low Birthweight.
247b–5.
Preventive health measures with respect
to prostate cancer.
247b–6.
National strategy for combating and
eliminating tuberculosis.
247b–7.
Loan repayment program.
247b–8.
Fellowship and training programs.
247b–9.
Diabetes in children and youth.
247b–9a.
Better diabetes care.
247b–10.
Compilation of data on asthma.
247b–11.
Effects of folic acid in prevention of
birth defects.
247b–12.
Safe motherhood.
247b–13.
Prenatal and postnatal health.
247b–14.
Oral health promotion and disease prevention.
247b–14a.
Identification of interventions that reduce the burden and transmission of
oral, dental, and craniofacial diseases
in high risk populations; development
of approaches for pediatric oral and
craniofacial assessment.
247b–15.
Surveillance and education regarding
hepatitis C virus.
247b–16.
Grants for lead poisoning related activities.
247b–17.
Human papillomavirus (Johanna’s Law).
247b–18.
Surveillance and research regarding
muscular dystrophy.
247b–19.
Information and education.
247b–20.
Food safety grants.
247b–21.
Mosquito-borne diseases; coordination
grants to States; assessment and control grants to political subdivisions.
247b–22.
Microbicide research.
247c.
Sexually transmitted diseases; prevention and control projects and programs.
247c–1.
Infertility and sexually transmitted diseases.
247c–2.
Data collection regarding programs
under subchapter XXIV.
247d.
Public health emergencies.
247d–1.
Vaccine tracking and distribution.
247d–2, 247d–3. Repealed.
247d–3a.
Improving State and local public health
security.
247d–3b.
Partnerships for State and regional hospital preparedness to improve surge capacity.
247d–4.
Revitalizing the Centers for Disease Control and Prevention.
247d–5.
Combating antimicrobial resistance.
247d–5a.
Identification of clinically susceptible
concentrations of antimicrobials.
247d–6.
Public health countermeasures to a bioterrorist attack.
247d–6a.
Authority for use of certain procedures
regarding qualified countermeasure research and development activities.

247d–6c.
247d–6d.
247d–6e.
247d–7.
247d–7a.
247d–7b.
247d–7c.
247d–7d.
247d–7e.
247d–7f.
247d–8.
247d–9.

Page 16

Strategic National Stockpile and security countermeasure procurements.
Reports regarding authorities under this
Act.
Targeted liability protections for pandemic and epidemic products and security countermeasures.
Covered countermeasure process.
Demonstration program to enhance bioterrorism training, coordination, and
readiness.
Grants regarding training and education
of certain health professionals.
Emergency system for advance registration of health professions volunteers.
Supplies and services in lieu of award
funds.
Security for countermeasure development and production.
Biomedical Advanced Research and Development Authority.
National Biodefense Science Board and
working groups.
Coordinated program to improve pediatric oral health.
Dental education for parents of newborns.

PART C—HOSPITALS, MEDICAL EXAMINATIONS, AND
MEDICAL CARE
247e.
248.

248a.
248b.
248c, 248d.
249.
250.
250a.
251.
252.
253.

253a.
253b.
254.
254a.

National Hansen’s Disease Programs
Center.
Control and management of hospitals;
furnishing prosthetic and orthopedic
devices; transfer of patients; disposal
of articles produced by patients; disposal of money and effects of deceased
patients; payment of burial expenses.
Closing or transfer of hospitals; reduction of services; Congressional authorization required.
Transfer or financial self-sufficiency of
public health service hospitals and
clinics.
Repealed.
Medical care and treatment of quarantined and detained persons.
Medical care and treatment of Federal
prisoners.
Transfer of appropriations.
Medical examination and treatment of
Federal employees; medical care at remote stations.
Medical examination of aliens.
Medical services to Coast Guard, National Oceanic and Atmospheric Administration, and Public Health Service.
Medical services to retired personnel of
National Oceanic and Atmospheric Administration.
Former Lighthouse Service employees;
medical service eligibility.
Interdepartmental work.
Sharing of medical care facilities and resources.
PART D—PRIMARY HEALTH CARE
SUBPART I—HEALTH CENTERS

254b.
254b–1.

254b–2.
254c.

Health centers.
State grants to health care providers
who provide services to a high percentage of medically underserved populations or other special populations.
Community health centers and the National Health Service Corps Fund.
Rural health care services outreach,
rural health network development, and
small health care provider quality improvement grant programs.

Page 17

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

254c–1.
254c–1a.
254c–2.
254c–3.
254c–4.

254c–5.
254c–6.
254c–7.

254c–8.
254c–9.
254c–10.
254c–11.
254c–12.
254c–13.
254c–14.
254c–15.
254c–16.
254c–17.
254c–18.

Grants for health services for Pacific Islanders.
Grants to nurse-managed health clinics.
Special diabetes programs for type I diabetes.
Special diabetes programs for Indians.
Centers for strategies on facilitating utilization of preventive health services
among various populations.
Epilepsy; seizure disorder.
Certain services for pregnant women.
Special needs adoption programs; public
awareness campaign and other activities.
Healthy start for infants.
Establishment of program of grants.
Certain requirements.
Technical assistance.
Definitions.
Authorization of appropriations.
Telehealth network and telehealth resource centers grant programs.
Rural emergency medical service training and equipment assistance program.
Mental health services delivered via
telehealth.
Repealed.
Telemedicine; incentive grants regarding
coordination among States.

SUBPART II—NATIONAL HEALTH SERVICE CORPS PROGRAM

254d.
254e.
254f.
254f–1.
254g.
254h.
254h–1.
254i.
254j.
254k.

National Health Service Corps.
Health professional shortage areas.
Corps personnel.
Priorities in assignment of Corps personnel.
Charges for services by entities using
Corps members.
Provision of health services by Corps
members.
Facilitation of effective provision of
Corps services.
Annual report to Congress; contents.
National Advisory Council on National
Health Service Corps.
Authorization of appropriations.

SUBPART III—SCHOLARSHIP PROGRAM AND LOAN
REPAYMENT PROGRAM

254l.
254l–1.
254m.
254n.
254o.
254o–1.

254p.
254q.
254q–1.
254r.
254s.
254t.
254u.

National Health Service Corps Scholarship Program.
National Health Service Corps Loan Repayment Program.
Obligated service under contract.
Private practice.
Breach of scholarship contract or loan
repayment contract.
Fund regarding use of amounts recovered for contract breach to replace
services lost as result of breach.
Special loans for former Corps members
to enter private practice.
Authorization of appropriations.
Grants to States for loan repayment programs.
Grants to States for operation of offices
of rural health.
Native Hawaiian Health Scholarships.
Demonstration project.
Public health departments.
SUBPART IV—HOME HEALTH SERVICES

255.

Grants to strengthen the effectiveness,
efficiency, and coordination of services
for the uninsured and underinsured.

Patient navigator grants.
Establishing community health teams to
support the patient-centered medical
home.
SUBPART VII—DRUG PRICING AGREEMENTS

256b.

Limitation on prices of drugs purchased
by covered entities.

SUBPART VIII—BULK PURCHASES OF VACCINES FOR
CERTAIN PROGRAMS

256c.
256d.

Bulk purchases of vaccines for certain
programs.
Breast and cervical cancer information.

SUBPART IX—SUPPORT OF GRADUATE MEDICAL
EDUCATION PROGRAMS IN CHILDREN’S HOSPITALS

256e.

Program of payments to children’s hospitals that operate graduate medical
education programs.
SUBPART X—PRIMARY DENTAL PROGRAMS

256f.
256g.
256g–1.

Designated dental health professional
shortage area.
Grants for innovative programs.
Demonstration program to increase access to dental health care services.

SUBPART XI—SUPPORT OF GRADUATE MEDICAL
EDUCATION IN QUALIFIED TEACHING HEALTH CENTERS

256h.

Program of payments to teaching health
centers that operate graduate medical
education programs.

SUBPART XII—COMMUNITY-BASED COLLABORATIVE CARE
NETWORK PROGRAM

256i.

Community-based
collaborative
network program.

care

PART E—NARCOTIC ADDICTS AND OTHER DRUG ABUSERS
257 to 261a. Repealed or Transferred.
PART F—LICENSING OF BIOLOGICAL PRODUCTS AND
CLINICAL LABORATORIES
SUBPART 1—BIOLOGICAL PRODUCTS

262.
262a.
263.

Regulation of biological products.
Enhanced control of dangerous biological agents and toxins.
Preparation of biological products by
Service.
SUBPART 2—CLINICAL LABORATORIES

263a.
263a–1.
263a–2.
263a–3.
263a–4.
263a–5.
263a–6.
263a–7.

Certification of laboratories.
Assisted reproductive technology programs.
Certification of embryo laboratories.
Accreditation organizations.
Certification revocation and suspension.
Publication.
Fees.
Definitions.
SUBPART 3—MAMMOGRAPHY FACILITIES

263b.

Certification of mammography facilities.
PART G—QUARANTINE AND INSPECTION

264.
265.

Home health services.

SUBPART V—HEALTHY COMMUNITIES ACCESS PROGRAM

256.

256a.
256a–1.

266.
267.

Regulations to control communicable
diseases.
Suspension of entries and imports from
designated places to prevent spread of
communicable diseases.
Special quarantine powers in time of
war.
Quarantine stations, grounds, and anchorages.

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 18

Sec.

Sec.

268.

Quarantine duties of consular and other
officers.
Bills of health.
Quarantine regulations governing civil
air navigation and civil aircraft.
Penalties for violation of quarantine
laws.
Administration of oaths by quarantine
officers.

269.
270.
271.
272.

PART H—ORGAN TRANSPLANTS
273.
273a.
273b.
274.
274a.
274b.
274c.
274d.
274e.
274f.
274f–1.
274f–2.
274f–3.
274f–4.
274g.

Organ procurement organizations.
National living donor mechanisms.
Report on the long-term health effects of
living organ donation.
Organ procurement and transplantation
network.
Scientific registry.
General provisions respecting grants and
contracts.
Administration.
Report.
Prohibition of organ purchases.
Reimbursement of travel and subsistence
expenses incurred toward living organ
donation.
Public awareness; studies and demonstrations.
Grants regarding hospital organ donation coordinators.
Studies relating to organ donation and
the recovery, preservation, and transportation of organs.
Report relating to organ donation and
the recovery, preservation, and transportation of organs.
Authorization of appropriations.

PART H–1—STEPHANIE TUBBS JONES GIFT OF LIFE
MEDAL
274i.
274i–1.
274i–2.
274i–3.
274i–4.

Eligibility requirements for Stephanie
Tubbs Jones Gift of Life Medal.
Solicitation of donations; prohibition on
use of Federal funds.
Design and production of medal.
Medals not treated as valuable consideration.
Definitions.

PART I—C.W. BILL YOUNG CELL TRANSPLANTATION
PROGRAM
274k.
274l.

National Program.
Stem cell therapeutic outcomes database.
274l–1.
Definitions.
274m.
Authorization of appropriations.
275 to 280a–1. Repealed.
PART J—PREVENTION AND CONTROL OF INJURIES

280b.
280b–1.
280b–1a.
280b–1b.
280b–1c.
280b–1d.
280b–1e.
280b–1f.
280b–2.
280b–3.
280b–4.

Research.
Prevention and control activities.
Interpersonal violence within families
and among acquaintances.
Use of allotments for rape prevention
education.
Prevention of traumatic brain injury.
National program for traumatic brain
injury surveillance and registries.
Study on traumatic brain injury.
Prevention of falls among older adults.
General provisions.
Authorization of appropriations.
Study conducted by the Centers for Disease Control and Prevention.

PART K—HEALTH CARE SERVICES IN THE HOME
SUBPART I—GRANTS FOR DEMONSTRATION PROJECTS

280c.

Establishment of program.

280c–1.
280c–2.

Limitation on duration of grant and requirement of matching funds.
General provisions.

SUBPART II—GRANTS FOR DEMONSTRATION PROJECTS
WITH RESPECT TO ALZHEIMER’S DISEASE

280c–3.
280c–4.
280c–5.

Establishment of program.
Requirement of matching funds.
General provisions.

SUBPART III—GRANTS FOR HOME VISITING SERVICES FOR
AT-RISK FAMILIES

280c–6.

Projects to improve maternal, infant,
and child health.

280d.
280d–11.

Transferred.
Transferred.

PART L—[REPEALED]

PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
280e.
280e–1.
280e–2.
280e–3.
280e–3a.
280e–4.

National program of cancer registries.
Planning grants regarding registries.
Technical assistance in operations of
statewide cancer registries.
Study in certain States to determine
factors contributing to elevated breast
cancer mortality rates.
National childhood cancer registry.
Authorization of appropriations.

PART N—NATIONAL FOUNDATION FOR THE CENTERS FOR
DISEASE CONTROL AND PREVENTION
280e–11.

Establishment and duties of Foundation.

PART O—FETAL ALCOHOL SYNDROME PREVENTION AND
SERVICES PROGRAM
280f to 280f–3. Omitted.
PART P—ADDITIONAL PROGRAMS
280g.
280g–1.
280g–2.
280g–3.
280g–4.
280g–5.
280g–6.
280g–7.
280g–8.

280g–9.
280g–10.
280g–11.
280g–12.
280g–13.
280g–14.
280g–15.
280g–16.

Children’s asthma treatment grants program.
Early detection, diagnosis, and treatment regarding hearing loss in newborns and infants.
Childhood malignancies.
.Controlled substance monitoring program.
Grants to foster public health responses
to domestic violence, dating violence,
sexual assault, and stalking.
Public and health care provider education and support services.
Chronic kidney disease initiatives.
Amyotrophic lateral sclerosis registry.
Support for patients receiving a positive
diagnosis of Down syndrome or other
prenatally or postnatally diagnosed
conditions.
Programs to improve quality of life for
persons with paralysis and other physical disabilities.
Community Preventive Services Task
Force.
Grants to promote positive health behaviors and outcomes.
Primary Care Extension Program.
National Congenital Heart Disease Surveillance System.
National diabetes prevention program.
State demonstration programs to evaluate alternatives to current medical
tort litigation.
Food Safety Integrated Centers of Excellence.

PART Q—PROGRAMS TO IMPROVE THE HEALTH OF
CHILDREN
280h.

Grants to promote childhood nutrition
and physical activity.

Page 19

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

280h–1.
280h–2.
280h–3.
280h–4.
280h–5.

Applied research program.
Education campaign.
Health professional education and training.
Grants for the establishment of schoolbased health centers.
School-based health centers.
PART R—PROGRAMS RELATING TO AUTISM

280i.

Developmental disabilities surveillance
and research program.
Autism education, early detection, and
intervention.
Interagency Autism Coordinating Committee.
Report to Congress.
Authorization of appropriations.

280i–1.
280i–2.
280i–3.
280i–4.

PART S—HEALTH CARE QUALITY PROGRAMS
SUBPART I—NATIONAL STRATEGY FOR QUALITY
IMPROVEMENT IN HEALTH CARE

280j.

National strategy for quality improvement in health care.
Collection and analysis of data for quality and resource use measures.
Public reporting of performance information.
Quality improvement program for hospitals with a high severity adjusted readmission rate.

280j–1.
280j–2.
280j–3.

PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
280k.
280k–1.
280k–2.
280k–3.

Oral healthcare prevention education
campaign.
Research-based dental caries disease
management.
Authorization of appropriations.
Updating national oral healthcare surveillance activities.

PART U—EMPLOYER-BASED WELLNESS PROGRAM
280l.

Technical assistance for employer-based
wellness programs.
National worksite health policies and
programs study.
Prioritization of evaluation by Secretary.
Prohibition
of
Federal
workplace
wellness requirements.

280l–1.
280l–2.
280l–3.

PART V—PROGRAMS RELATING TO BREAST HEALTH AND
CANCER
280m.

Young women’s breast health awareness
and support of young women diagnosed
with breast cancer.
SUBCHAPTER III—NATIONAL RESEARCH
INSTITUTES
PART A—NATIONAL INSTITUTES OF HEALTH

281.
282.
282a.
282b.
282c.
282d.
283.
283a.
283a–1.
283a–2.

Organization of National Institutes of
Health.
Director of National Institutes of
Health.
Authorization of appropriations.
Electronic coding of grants and activities.
Public access to funded investigators’
final manuscripts.
Cures Acceleration Network.
Biennial reports of Director of NIH.
Annual reporting to increase interagency collaboration and coordination.
Annual reporting to prevent fraud and
abuse.
Annual reporting regarding training of
graduate students for doctoral degrees.

283a–3.
283b.
283c.
283d.
283e.
283f.
283g.
283h.
283i.
283j.

Establishment of program regarding
DES.
Repealed.
Office of Behavioral and Social Sciences
Research.
Children’s Vaccine Initiative.
Plan for use of animals in research.
Requirements regarding surveys of sexual behavior.
Muscular dystrophy; initiative through
Director of National Institutes of
Health.
Office of Rare Diseases.
Rare disease regional centers of excellence.
Review of centers of excellence.

PART B—GENERAL PROVISIONS RESPECTING NATIONAL
RESEARCH INSTITUTES
284.
284a.
284b.
284c.
284d.
284e.
284f.
284g.

284h.
284i.
284j.
284k.
284l.
284m.
284n.
284o.

284p.

284q.

Directors of national research institutes.
Advisory councils.
Repealed.
Certain uses of funds.
Definitions.
Research on osteoporosis, Paget’s disease, and related bone disorders.
Parkinson’s disease.
Expansion, intensification, and coordination of activities of National Institutes
of Health with respect to research on
autism spectrum disorder.
Pediatric Research Initiative.
Autoimmune diseases.
Muscular dystrophy research.
Clinical research.
Enhancement awards.
Program for pediatric studies of drugs.
Certain demonstration projects.
Activities of the National Institutes of
Health with respect to research on paralysis.
Activities of the National Institutes of
Health with respect to research with
implications for enhancing daily function for persons with paralysis.
Pain research.

PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL
RESEARCH INSTITUTES
SUBPART 1—NATIONAL CANCER INSTITUTE

285.
285a.
285a–1.
285a–2.
285a–3.
285a–4.
285a–5.
285a–6.
285a–7.
285a–8.
285a–9.

285a–10.
285a–11.
285a–12.

Purpose of Institute.
National Cancer Program.
Cancer control programs.
Special authorities of Director.
National cancer research and demonstration centers.
President’s Cancer Panel; establishment,
membership, etc., functions.
Associate Director for Prevention; appointment; function.
Breast and gynecological cancers.
Prostate cancer.
Repealed.
Grants for education, prevention, and
early detection of radiogenic cancers
and diseases.
Research, information, and education
with respect to blood cancer.
Pediatric cancer research and awareness.
Interagency Breast Cancer and Environmental Research Coordinating Committee.

SUBPART 2—NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE

285b.
285b–1.

Purpose of Institute.
Heart, blood vessel, lung, and blood disease prevention and control programs.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Sec.

285b–2.
285b–3.
285b–4.
285b–5.
285b–6.
285b–7.
285b–7a.
285b–7b.
285b–7c.
285b–8.

Information and education.
National Heart, Blood Vessel, Lung, and
Blood Diseases and Blood Resources
Program; administrative provisions.
National research and demonstration
centers.
Repealed.
Associate Director for Prevention; appointment; function.
National Center on Sleep Disorders Research.
Heart attack, stroke, and other cardiovascular diseases in women.
Coordination of Federal asthma activities.
Tuberculosis.
Congenital heart disease.

SUBPART 3—NATIONAL INSTITUTE OF DIABETES AND
DIGESTIVE AND KIDNEY DISEASES

285c.
285c–1.

Purpose of Institute.
Data systems and information clearinghouses.
Division Directors for Diabetes, Endocrinology, and Metabolic Diseases, Digestive Diseases and Nutrition, and
Kidney, Urologic, and Hematologic
Diseases; functions.
Interagency coordinating committees.
Advisory boards.
Research and training centers; development or expansion.
Advisory council subcommittees.
Biennial report.
Nutritional disorders program.
Juvenile diabetes.

285c–2.

285c–3.
285c–4.
285c–5.
285c–6.
285c–7.
285c–8.
285c–9.

SUBPART 4—NATIONAL INSTITUTE OF ARTHRITIS AND
MUSCULOSKELETAL AND SKIN DISEASES

285d.
285d–1.
285d–2.
285d–3.
285d–4.
285d–5.
285d–6.
285d–6a.
285d–7.
285d–8.

Purpose of Institute.
National arthritis and musculoskeletal
and skin diseases program.
Research and training.
Data system and information clearinghouse.
Interagency coordinating committees.
Arthritis and musculoskeletal diseases
demonstration projects.
Multipurpose arthritis and musculoskeletal diseases centers.
Lupus.
Advisory Board.
Juvenile arthritis and related conditions.

SUBPART 5—NATIONAL INSTITUTE ON AGING

285e.
285e–1.
285e–2.
285e–3.
285e–4.
285e–5.

285e–6.
285e–7.
285e–8.
285e–9.
285e–10.
285e–10a.
285e–11.

Purpose of Institute.
Special functions.
Alzheimer’s Disease centers.
Claude D. Pepper Older Americans Independence Centers.
Awards for leadership and excellence in
Alzheimer’s disease and related dementias.
Research relevant to appropriate services for individuals with Alzheimer’s
disease and related dementias and
their families.
Dissemination of research results.
Clearinghouse on Alzheimer’s Disease.
Dissemination project.
Alzheimer’s disease registry.
Aging processes regarding women.
Alzheimer’s clinical research and training awards.
Repealed.

SUBPART 6—NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES

285f.

Page 20

Purpose of Institute.

285f–1.
285f–2.
285f–3.
285f–4.

Research centers regarding chronic fatigue syndrome.
Research and research training regarding tuberculosis.
Sexually transmitted disease clinical research and training awards.
Microbicide research and development.

SUBPART 7—EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

285g.
285g–1.
285g–2.
285g–3.
285g–4.
285g–5.
285g–6.
285g–7.
285g–8.
285g–9.
285g–10.

Purpose of Institute.
Sudden infant death syndrome research.
Research on intellectual disabilities.
Associate Director for Prevention; appointment; function.
National Center for Medical Rehabilitation Research.
Research centers with respect to contraception and infertility.
Program regarding obstetrics and gynecology.
Child health research centers.
Prospective longitudinal study on adolescent health.
Fragile X.
Investment in tomorrow’s pediatric researchers.

SUBPART 8—NATIONAL INSTITUTE OF DENTAL RESEARCH

285h.

Purpose of Institute.
SUBPART 9—NATIONAL EYE INSTITUTE

285i.
285i–1.

Purpose of Institute.
Clinical research on eye care and diabetes.

SUBPART 10—NATIONAL INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE

285j.
285j–1.
285j–2.
285j–3.

Purpose of Institute.
Spinal cord regeneration research.
Bioengineering research.
Research on multiple sclerosis.

SUBPART 11—NATIONAL INSTITUTE OF GENERAL MEDICAL
SCIENCES

285k.

Purpose of Institute.

SUBPART 12—NATIONAL INSTITUTE OF ENVIRONMENTAL
HEALTH SCIENCES

285l.
285l–1.
285l–2.
285l–3.
285l–4.
285l–5.
285l–6.

Purpose of Institute.
Applied Toxicological Research and
Testing Program.
Definitions.
Interagency Coordinating Committee on
the Validation of Alternative Methods.
Federal agency action.
Application.
Methods of controlling certain insect
and vermin populations.

SUBPART 13—NATIONAL INSTITUTE ON DEAFNESS AND
OTHER COMMUNICATION DISORDERS

285m.
285m–1.
285m–2.
285m–3.
285m–4.

285m–5.
285m–6.

Purpose of Institute.
National Deafness and Other Communication Disorders Program.
Data System and Information Clearinghouse.
Multipurpose deafness and other communication disorders center.
National Institute on Deafness and Other
Communication Disorders Advisory
Board.
Interagency Coordinating Committee.
Limitation on administrative expenses.

SUBPART 14—NATIONAL INSTITUTE ON ALCOHOL ABUSE
AND ALCOHOLISM

285n.

Purpose of Institute.

Page 21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

285n–1.
285n–2.

SUBPART 15—NATIONAL INSTITUTE ON DRUG ABUSE

285o.
285o–1.
285o–2.
285o–3.
285o–4.

Purpose of Institute.
Associate Director for Prevention.
Drug Abuse Research Centers.
Office on AIDS.
Medication Development Program.

SUBPART 16—NATIONAL INSTITUTE OF MENTAL HEALTH

285p.
285p–1.
285p–2.
285p–3.

Purpose of Institute.
Associate Director for Prevention.
Office of Rural Mental Health Research.
Office on AIDS.

SUBPART 17—NATIONAL INSTITUTE OF NURSING RESEARCH

285q.
285q–1.
285q–2.
285q–3.

Purpose of Institute.
Specific authorities.
Advisory council.
Biennial report.

SUBPART 18—NATIONAL INSTITUTE OF BIOMEDICAL
IMAGING AND BIOENGINEERING

285r.

Purpose of the Institute.

SUBPART 19—NATIONAL HUMAN GENOME RESEARCH
INSTITUTE

285s.

285t–2.
285t–3.

Purpose of Institute.
Centers of excellence for research education and training.
Loan repayment program for minority
health disparities research.
General provisions regarding the Institute.
PART D—NATIONAL LIBRARY OF MEDICINE

286.
286a.
286a–1.
286a–2.

286b–3.
286b–4.

286b–5.
286b–6.
286b–7.
286b–8.

287a–3a.
287a–4.

287b.

General purpose.

SUBPART 3—NATIONAL CENTER FOR HUMAN GENOME
RESEARCH

287c.

Transferred.
SUBPART 4—OFFICE OF DIETARY SUPPLEMENTS

287c–11.

Purpose, establishment, functions, and
funding of National Center for Biotechnology Information.

National Information Center.

Dietary supplements.

SUBPART 5—NATIONAL CENTER FOR COMPLEMENTARY AND
ALTERNATIVE MEDICINE

287c–21.

Purpose of Center.
SUBPART 6—TRANSFERRED

287c–31 to 287c–34. Transferred.
PART F—RESEARCH ON WOMEN’S HEALTH
287d.
287d–1.
287d–2.

Office of Research on Women’s Health.
National data system and clearinghouse
on research on women’s health.
Biennial report.
PART G—AWARDS AND TRAINING

288.

288–2.

Repealed.
Definitions.
National Medical Libraries Assistance
Advisory Board.
Grants for training in medical library
sciences.
Assistance for projects in sciences related to health, for research and development in medical library science, and
for development of education technologies.
Grants for establishing, expanding, and
improving basic resources of medical
libraries and related instrumentalities.
Grants and contracts for establishment
of regional medical libraries.
Financial support of biomedical scientific publications.
Grant payments, records, and audit.

General purpose.
Advisory council.
Biennial report.
Biomedical and behavioral research facilities.
Construction of regional centers for research on primates.
Sanctuary system for surplus chimpanzees.
General clinical research centers.

SUBPART 2—JOHN E. FOGARTY INTERNATIONAL CENTER
FOR ADVANCED STUDY IN HEALTH SCIENCES

288–1.

SUBPART 4—NATIONAL INFORMATION CENTER ON HEALTH
SERVICES RESEARCH AND HEALTH CARE TECHNOLOGY

286d.

287a–3.

National Library of Medicine.
Board of Regents.
Library facilities.
Repealed.

SUBPART 3—NATIONAL CENTER FOR BIOTECHNOLOGY
INFORMATION

286c.

287.
287a.
287a–1.
287a–2.

SUBPART 1—GENERAL PROVISIONS

SUBPART 2—FINANCIAL ASSISTANCE

286b.
286b–1.
286b–2.

SUBPART 1—NATIONAL CENTER FOR RESEARCH
RESOURCES

Purpose of Institute.

SUBPART 20—NATIONAL INSTITUTE ON MINORITY HEALTH
AND HEALTH DISPARITIES

285t.
285t–1.

PART E—OTHER AGENCIES OF NIH

Associate Director for Prevention.
National Alcohol Research Centers;
mandatory grant for research of effects
of alcohol on elderly.

288–3.
288–4.

288–5.

288–5a.
288–6.
288a.
288b.

Ruth L. Kirschstein National Research
Service Awards.
Loan repayment program for research
with respect to acquired immune deficiency syndrome.
Loan repayment program for research
with respect to contraception and infertility.
Loan repayment program for research
generally.
Undergraduate scholarship program regarding professions needed by National
Research Institutes.
Loan repayment program regarding clinical researchers from disadvantaged
backgrounds.
Loan repayment program regarding clinical researchers.
Pediatric research loan repayment program.
Visiting Scientist Awards.
Studies respecting biomedical and behavioral research personnel.
PART H—GENERAL PROVISIONS

289.
289a.
289a–1.
289a–2.
289b.
289b–1.
289c.
289c–1.

Institutional review boards; ethics guidance program.
Peer review requirements.
Certain provisions regarding review and
approval of proposals for research.
Inclusion of women and minorities in
clinical research.
Office of Research Integrity.
Protection against financial conflicts of
interest in certain projects of research.
Research on public health emergencies.
Collaborative use of certain health services research funds.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

289d.
289e.
289f.
289g.
289g–1.
289g–2.
289g–3.
289g–4.
289h.
290.

290a.

Sec.

Animals in research.
Use of appropriations.
Gifts and donations; memorials.
Fetal research.
Research on transplantation of fetal tissue.
Prohibitions regarding human fetal tissue.
Breast implant research.
Support for emergency medicine research.
Repealed.
National Institutes of Health Management Fund; establishment; advancements; availability; final adjustments
of advances.
Victims of fire.

PART I—FOUNDATION FOR THE NATIONAL INSTITUTES OF
HEALTH
290b.

Establishment and duties of Foundation.

SUBCHAPTER III–A—SUBSTANCE ABUSE AND
MENTAL HEALTH SERVICES ADMINISTRATION
PART A—ORGANIZATION AND GENERAL AUTHORITIES
290aa.
290aa–1.
290aa–2.
290aa–2a.

290aa–3.
290aa–3a.
290aa–4.
290aa–5.
290aa–5a.

290aa–5b.
290aa–6 to

Substance Abuse and Mental Health
Services Administration.
Advisory councils.
Omitted.
Report on individuals with co-occurring
mental illness and substance abuse disorders.
Peer review.
Transferred.
Data collection.
Grants for the benefit of homeless individuals.
Alcohol and drug prevention or treatment services for Indians and Native
Alaskans.
Grants for ecstasy and other club drugs
abuse prevention.
290aa–14. Transferred or Repealed.
PART B—CENTERS AND PROGRAMS

SUBPART 1—CENTER FOR SUBSTANCE ABUSE TREATMENT

290bb.
290bb–1.

Center for Substance Abuse Treatment.
Residential treatment programs for
pregnant and postpartum women.
290bb–1a.
Transferred.
290bb–2.
Priority substance abuse treatment
needs of regional and national significance.
290bb–2a.
Medical treatment of narcotics addiction; report to Congress.
290bb–3 to 290bb–5. Repealed.
290bb–6.
Action by Center for Substance Abuse
Treatment and States concerning military facilities.
290bb–7.
Substance abuse treatment services for
children and adolescents.
290bb–8.
Early intervention services for children
and adolescents.
290bb–9.
Methamphetamine and amphetamine
treatment initiative.
SUBPART 2—CENTER FOR SUBSTANCE ABUSE PREVENTION

290bb–21.
290bb–22.

290bb–23.

290bb–24.
290bb–25.

Page 22

Office for Substance Abuse Prevention.
Priority substance abuse prevention
needs of regional and national significance.
Prevention, treatment, and rehabilitation model projects for high risk
youth.
Repealed.
Grants for services for children of substance abusers.

290bb–25a.
290bb–25b.
290bb–25c.
290bb–25d.

290bb–25e.
290bb–25f.

Grants for strengthening families.
Programs to reduce underage drinking.
Services for individuals with fetal alcohol syndrome.
Centers of excellence on services for individuals with fetal alcohol syndrome
and alcohol-related birth defects and
treatment for individuals with such
conditions and their families.
Prevention of methamphetamine and inhalant abuse and addiction.
Prevention and education programs.

SUBPART 3—CENTER FOR MENTAL HEALTH SERVICES

290bb–31.
290bb–32.

Center for Mental Health Services.
Priority mental health needs of regional
and national significance.
290bb–33.
National centers of excellence for depression.
290bb–34.
Youth interagency research, training,
and technical assistance centers.
290bb–35.
Services for youth offenders.
290bb–36.
Youth suicide early intervention and
prevention strategies.
290bb–36a.
Suicide prevention for youth.
290bb–36b.
Mental and behavioral health services on
campus.
290bb–37.
Grants for emergency mental health centers.
290bb–38.
Grants for jail diversion programs.
290bb–39.
Improving outcomes for children and
adolescents through services integration between child welfare and mental
health services.
290bb–40.
Grants for the integrated treatment of
serious mental illness and co-occurring
substance abuse.
290bb–41.
Training grants.
290bb–42.
Awards for co-locating primary and specialty care in community-based mental health settings.
290cc to 290cc–13. Repealed or Transferred.
PART C—PROJECTS FOR ASSISTANCE IN TRANSITION
FROM HOMELESSNESS
290cc–21.
290cc–22.
290cc–23.
290cc–24.
290cc–25.
290cc–26.
290cc–27.
290cc–28.
290cc–29.
290cc–30.
290cc–31.
290cc–32.
290cc–33.
290cc–34.
290cc–35.

Formula grants to States.
Purpose of grants.
Requirement of matching funds.
Determination of amount of allotment.
Conversion to categorical program in
event of failure of State regarding expenditure of grants.
Provision of certain information from
State.
Description of intended expenditures of
grant.
Requirement of reports by States.
Requirement of application.
Technical assistance.
Failure to comply with agreements.
Prohibition against certain false statements.
Nondiscrimination.
Definitions.
Funding.

PART D—MISCELLANEOUS PROVISIONS RELATING TO
SUBSTANCE ABUSE AND MENTAL HEALTH
290dd.

Substance abuse among government and
other employees.
290dd–1.
Admission of substance abusers to private and public hospitals and outpatient facilities.
290dd–2.
Confidentiality of records.
290dd–3 to 290ee–3. Omitted.
PART E—CHILDREN WITH SERIOUS EMOTIONAL
DISTURBANCES
290ff.

Comprehensive
community
mental
health services for children with serious emotional disturbances.

Page 23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

290ff–1.
290ff–2.
290ff–3.
290ff–4.

Requirements with respect to carrying
out purpose of grants.
Individualized plan for services.
Additional provisions.
General provisions.

PART F—MODEL COMPREHENSIVE PROGRAM FOR
TREATMENT OF SUBSTANCE ABUSE
290gg.

Children and violence.
Grants to address the problems of persons who experience violence related
stress.

PART H—REQUIREMENT RELATING TO THE RIGHTS OF
RESIDENTS OF CERTAIN FACILITIES
290ii.
290ii–1.
290ii–2.

290jj–1.
290jj–2.

Requirement relating to the rights of
residents of certain non-medical, community-based facilities for children
and youth.
Reporting requirement.
Regulations and enforcement.

PART J—SERVICES PROVIDED THROUGH RELIGIOUS
ORGANIZATIONS
290kk.
290kk–1.
290kk–2.
290kk–3.

Applicability to designated programs.
Religious organizations as program participants.
Limitations on use of funds for certain
purposes.
Educational requirements for personnel
in drug treatment programs.

291n, 291n–1.
291o.
291o–1.

PART A—STUDENT LOANS
SUBPART I–INSURED HEALTH EDUCATION ASSISTANCE
LOANS TO GRADUATE STUDENTS

292.
292a.
292b.
292c.
292d.
292e.
292f.
292g.
292h.
292i.
292j.
292k.

291.

292n.

PART A—GRANTS AND LOANS FOR CONSTRUCTION AND
MODERNIZATION OF HOSPITALS AND OTHER MEDICAL
FACILITIES

291f.
291g.
291h.
291i.
291j.

Authorization of appropriations.
State allotments.
General regulations.
State plans.
Projects for construction or modernization.
Payments for construction or modernization.
Withholding of payments; noncompliance with requirements.
Judicial review.
Recovery of expenditures under certain
conditions.
Loans.

PART B—LOAN GUARANTEES AND LOANS FOR MODERNIZATION AND CONSTRUCTION OF HOSPITALS AND
OTHER MEDICAL FACILITIES
291j–1.
291j–2.
291j–3.
291j–4.
291j–5.
291j–6.

Loan guarantees and loans.
Allocation among States.
Applications and conditions.
Payment of interest on guaranteed
loans.
Limitation on amounts of loans guaranteed or directly made.
Loan guarantee and loan fund.

Federal Hospital Council.
Conference of State agencies.
State control of operations.
Loans for certain hospital experimentation projects.
Repealed or Omitted.
Definitions.
Financial statements.

SUBCHAPTER V—HEALTH PROFESSIONS
EDUCATION

292l.
292m.

Congressional declaration of purpose.

Authorization of appropriations.
Eligibility for grants.
Payments.
PART D—GENERAL PROVISIONS

291k.
291l.
291m.
291m–1.

SUBCHAPTER
IV—CONSTRUCTION
AND
MODERNIZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES

291a.
291b.
291c.
291d.
291e.

Loans to public facilities.
C—CONSTRUCTION OR MODERNIZATION OF
EMERGENCY ROOMS

291j–8.
291j–9.
291j–10.

Requirement relating to the rights of
residents of certain facilities.
Reporting requirement.
Regulations and enforcement.

PART I—REQUIREMENT RELATING TO THE RIGHTS OF
RESIDENTS OF CERTAIN NON-MEDICAL, COMMUNITYBASED FACILITIES FOR CHILDREN AND YOUTH
290jj.

PART

Repealed.

PART G—PROJECTS FOR CHILDREN AND VIOLENCE
290hh.
290hh–1.

291j–7.

292o.
292p.

Statement of purpose.
Scope and duration of loan insurance
program.
Limitations on individual insured loans
and on loan insurance.
Sources of funds.
Eligibility of borrowers and terms of insured loans.
Certificate of loan insurance; effective
date of insurance.
Default of borrower.
Risk-based premiums.
Office for Health Education Assistance
Loan Default Reduction.
Insurance account.
Powers and responsibilities of Secretary.
Participation by Federal credit unions in
Federal, State, and private student
loan insurance programs.
Determination of eligible students.
Repayment by Secretary of loans of deceased or disabled borrowers.
Additional requirements for institutions
and lenders.
Definitions.
Authorization of appropriations.

SUBPART II—FEDERALLY-SUPPORTED STUDENT LOAN
FUNDS

292q.
292r.
292s.
292t.
292u.
292v.
292w.
292x.
292y.

Agreements for operation of school loan
funds.
Loan provisions.
Medical schools and primary health care.
Individuals from disadvantaged backgrounds.
Administrative provisions.
Provision by schools of information to
students.
Procedures for appeal of termination of
agreements.
Distribution of assets from loan funds.
General provisions.
PART B—HEALTH PROFESSIONS TRAINING FOR
DIVERSITY

293.
293a.
293b.
293c.

293d.

Centers of excellence.
Scholarships for disadvantaged students.
Loan repayments and fellowships regarding faculty positions.
Educational assistance in the health professions regarding individuals from disadvantaged backgrounds.
Authorization of appropriation.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Page 24

Sec.

293e.

Grants for health professions education.

295f–1.

PART C—TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL PEDIATRICS, PHYSICIAN
ASSISTANTS, GENERAL DENTISTRY, AND PEDIATRIC
DENTISTRY

295f–2.
295f–3.

SUBPART 1—MEDICAL TRAINING GENERALLY

293j.
293k.
293k–1.

Repealed.
Primary care training and enhancement.
Training opportunities for direct care
workers.
Training in general, pediatric, and public
health dentistry.
Advisory Committee on Training in Primary Care Medicine and Dentistry.
Teaching health centers development
grants.

293k–2.
293l.
293l–1.

SUBPART 2—TRAINING IN UNDERSERVED COMMUNITIES

293m.
293n to 293p.

Rural physician training grants.
Repealed.

PART D—INTERDISCIPLINARY, COMMUNITY-BASED
LINKAGES
294.
294a.
294b.

294c.
294d.
294e.
294e–1.
294f.
294g.
294h.

294i.
294j.

General provisions.
Area health education centers.
Continuing educational support for
health professionals serving in underserved communities.
Education and training relating to geriatrics.
Quentin N. Burdick program for rural
interdisciplinary training.
Allied health and other disciplines.
Mental and behavioral health education
and training grants.
Advisory Committee on Interdisciplinary, Community-Based Linkages.
Repealed.
Interdisciplinary training and education
on domestic violence and other types
of violence and abuse.
Program for education and training in
pain care.
Demonstration program to integrate
quality improvement and patient safety training into clinical education of
health professionals.

PART E—HEALTH PROFESSIONS AND PUBLIC HEALTH
WORKFORCE
SUBPART 1—HEALTH PROFESSIONS WORKFORCE
INFORMATION AND ANALYSIS

294n.
294o.
294p.
294q.
294r.

Health professions workforce information and analysis.
Advisory Council on Graduate Medical
Education.
Pediatric rheumatology.
National Health Care Workforce Commission.
State health care workforce development grants.
SUBPART 2—PUBLIC HEALTH WORKFORCE

295.
295a.
295b.
295c.
295d.
295e.

General provisions.
Public health training centers.
Public health traineeships.
Preventive medicine and public health
training grant program.
Health administration traineeships and
special projects.
Authorization of appropriations.

SUBPART 3—RECRUITMENT AND RETENTION PROGRAMS

295f.

Investment in tomorrow’s
health care workforce.

pediatric

Public Health Workforce Loan Repayment Program.
Training for mid-career public and allied
health professionals.
Fellowship training in applied public
health epidemiology, public health laboratory science, public health informatics, and expansion of the Epidemic
Intelligence Service.
PART F—GENERAL PROVISIONS

295j.
295k.
295l.
295m.
295n.
295n–1.
295n–2.
295o.
295o–1.
295o–2.
295p.

Preferences and required information in
certain programs.
Health professions data.
Repealed.
Prohibition against discrimination on
basis of sex.
Repealed.
Application.
Use of funds.
Matching requirement.
Generally applicable provisions.
Technical assistance.
Definitions.

SUBCHAPTER VI—NURSING WORKFORCE
DEVELOPMENT
PART A—GENERAL PROVISIONS
296.
296a.
296b.
296c.
296d.
296e.
296e–1.
296f.
296g.

Definitions.
Application.
Use of funds.
Matching requirement.
Preference.
Generally applicable provisions.
Grants for health professions education.
Technical assistance.
Prohibition against discrimination by
schools on basis of sex.

PART B—NURSE PRACTITIONERS, NURSE MIDWIVES,
NURSE ANESTHETISTS, AND OTHER ADVANCED EDUCATION NURSES
296j.
296j–1.

Advanced education nursing grants.
Demonstration grants for family nurse
practitioner training programs.

PART C—INCREASING NURSING WORKFORCE DIVERSITY
296m.

Workforce diversity grants.

PART D—STRENGTHENING CAPACITY FOR BASIC NURSE
EDUCATION AND PRACTICE
296p.
296p–1.

Nurse education, practice, and quality
grants.
Nurse retention grants.
PART E—STUDENT LOANS

297a.
297b.
297c, 297c–1.
297d.
297e.
297f.
297g.
297h.
297i.
297n.
297n–1.
297o.

Student loan fund.
Loan provisions.
Repealed.
Allotments and payments of Federal
capital contributions.
Distribution of assets from loan funds.
Repealed.
Modification
of
agreements;
compromise, waiver or release.
Repealed.
Procedures for appeal of terminations.
Loan repayment and scholarship programs.
Nurse faculty loan program.
Eligible individual student loan repayment.

PART F—NATIONAL ADVISORY COUNCIL ON NURSE
EDUCATION AND PRACTICE
297t.

National Advisory Council on Nurse Education and Practice.

Page 25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

PART G—PUBLIC SERVICE ANNOUNCEMENTS
297w.
297x.

Public service announcements.
State and local public service announcements.

PART H—COMPREHENSIVE GERIATRIC EDUCATION
298.

Comprehensive geriatric education.

298d.

Authorization of appropriations.

PART I—FUNDING
SUBCHAPTER VII—AGENCY FOR HEALTHCARE
RESEARCH AND QUALITY
PART A—ESTABLISHMENT AND GENERAL DUTIES
299.
299a.
299a–1.

Mission and duties.
General authorities.
Research on health disparities.

PART B—HEALTH CARE IMPROVEMENT RESEARCH
299b.

Health care outcome improvement research.
Private-public partnerships to improve
organization and delivery.
Information on quality and cost of care.
Information systems for health care improvement.
Research supporting primary care and
access in underserved areas.
Studies on preventive interventions in
primary care for older Americans.
Health care practice and technology innovation.
Coordination of Federal Government
quality improvement efforts.
Research on outcomes of health care
items and services.
Federal Coordinating Council for Comparative Effectiveness Research.

299b–1.
299b–2.
299b–3.
299b–4.
299b–4a.
299b–5.
299b–6.
299b–7.
299b–8.

PART C—PATIENT SAFETY IMPROVEMENT
299b–21.
299b–22.
299b–23.
299b–24.
299b–24a.
299b–25.
299b–26.

Definitions.
Privilege and confidentiality protections.
Network of patient safety databases.
Patient safety organization certification
and listing.
Activities regarding women’s health.
Technical assistance.
Severability.

299c–3.
299c–4.

Dissemination of information.
Additional provisions with respect to
grants and contracts.
299c–5.
Certain administrative authorities.
299c–6.
Funding.
299c–7.
Definitions.
SUBCHAPTER VIII—POPULATION RESEARCH AND
VOLUNTARY FAMILY PLANNING PROGRAMS
300.

300a.
300a–1.
300a–2.
300a–3.
300a–4.
300a–5.

300a–6.

300a–6a.
300a–7.
300a–8.

PART A—GRANT PROGRAM
300a–21 to 300a–29. Repealed or Omitted.
PART B—IMPROVING COORDINATION OF FEDERAL AND
STATE PROGRAMS
300a–41.
Repealed.
SUBCHAPTER IX—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT
DEATH SYNDROME
PART A—GENETIC DISEASES
300b.
300b–1.
300b–2.
300b–3.

PART D—HEALTH CARE QUALITY IMPROVEMENT
SUBPART 1—QUALITY MEASURE DEVELOPMENT

299b–31.

Quality measure development.

SUBPART 2—HEALTH CARE QUALITY IMPROVEMENT
PROGRAMS

299b–33.
299b–34.
299b–35.

299b–36.
299b–37.

Health care delivery system research.
Quality improvement technical assistance and implementation.
Grants or contracts to implement medication management services in treatment of chronic diseases.
Program to facilitate shared decisionmaking.
Dissemination and building capacity for
research.
PART E—GENERAL PROVISIONS

299c.
299c–1.
299c–2.

Advisory Council for Healthcare Research and Quality.
Peer review with respect to grants and
contracts.
Certain provisions with respect to development, collection, and dissemination
of data.

Project grants and contracts for family
planning services.
Formula grants to States for family
planning services.
Training grants and contracts; authorization of appropriations.
Conduct, etc., of research activities.
Informational and educational materials
development grants and contracts; authorization of appropriations.
Grants and contracts.
Voluntary participation by individuals;
participation not prerequisite for eligibility or receipt of other services and
information.
Prohibition against funding programs
using abortion as family planning
method.
Repealed.
Sterilization or abortion.
Penalty for United States, etc., officer or
employee coercing or endeavoring to
coerce procedure upon beneficiary of
Federal program.
SUBCHAPTER VIII–A—ADOLESCENT
PREGNANCIES

300b–4.
300b–5.
300b–6.
300b–7.
300b–8.
300b–9.
300b–10.
300b–11.
300b–12.
300b–13.
300b–14.
300b–15.

Repealed.
Research project grants and contracts.
Voluntary participation by individuals.
Application; special consideration to
prior sickle cell anemia grant recipients.
Public Health Service facilities.
Repealed.
Applied technology.
Tourette Syndrome.
Improved newborn and child screening
for heritable disorders.
Evaluating the effectiveness of newborn
and child screening programs.
Advisory Committee on Heritable Disorders in Newborns and Children.
Clearinghouse of newborn screening information.
Laboratory quality.
Interagency Coordinating Committee on
Newborn and Child Screening.
National contingency plan for newborn
screening.
Hunter Kelly Research Program.

PART B—SUDDEN INFANT DEATH SYNDROME
300c–11.
300c–12.

Repealed.
Sudden infant death syndrome research.
PART C—HEMOPHILIA PROGRAMS

300c–21.

Repealed.

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 26

Sec.

Sec.

300c–22.

Blood-separation centers.
SUBCHAPTER X—TRAUMA CARE

PART A—GENERAL AUTHORITY AND DUTIES OF
SECRETARY
300d.
Establishment.
300d–1, 300d–2. Repealed.
300d–3.
Establishment of programs for improving trauma care in rural areas.
300d–4.
Emergency medical services.
300d–5.
Competitive grants for trauma systems
for the improvement of trauma care.
300d–6.
Competitive grants for regionalized systems for emergency care response.
PART B—FORMULA GRANTS WITH RESPECT TO
MODIFICATIONS OF STATE PLANS
300d–11.
300d–12.
300d–13.
300d–14.
300d–15.
300d–16.
300d–17.
300d–18.
300d–19.
300d–20.
300d–21.

300d–22.

Establishment of program.
Requirement of matching funds for fiscal
years subsequent to first fiscal year of
payments.
Requirements with respect to carrying
out purpose of allotments.
Requirement of submission to Secretary
of trauma plan and certain information.
Restrictions on use of payments.
Repealed.
Requirement of submission of application containing certain agreements
and assurances.
Determination of amount of allotment.
Failure to comply with agreements.
Prohibition against certain false statements.
Technical assistance and provision by
Secretary of supplies and services in
lieu of grant funds.
Report by Secretary.

PART C—GENERAL PROVISIONS REGARDING PARTS A
AND B
300d–31.
300d–32.
300d–33.

Definitions.
Funding.
Repealed.

PART D—TRAUMA CENTERS OPERATING IN AREAS
SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
300d–41.
300d–42.
300d–43.
300d–44.
300d–45.
300d–46.

Grants for certain trauma centers.
Preferences in making grants.
Certain agreements.
General provisions.
Authorization of appropriations.
Definition.
PART E—MISCELLANEOUS PROGRAMS

300d–51.
300d–52.
300d–53.

Residency training programs in emergency medicine.
State grants for projects regarding traumatic brain injury.
State grants for protection and advocacy
services.

PART F—INTERAGENCY PROGRAM FOR TRAUMA
RESEARCH
300d–61.

300d–72.
300d–73.
300d–74.

Maintenance of the national toll-free
number.
Nationwide media campaign to promote
poison control center utilization.
Maintenance of the poison control center
grant program.
Rule of construction.
PART H—TRAUMA SERVICE AVAILABILITY

300d–81.

300e.

Requirements of health maintenance organizations.
300e–1.
Definitions.
300e–2, 300e–3. Repealed.
300e–4.
Loans and loan guarantees for initial operation costs.
300e–4a.
Repealed.
300e–5.
Application requirements.
300e–6.
Administration of assistance programs.
300e–7.
General provisions relating to loan guarantees and loans.
300e–8.
Authorization of appropriations.
300e–9.
Employees’ health benefits plans.
300e–10.
Restrictive State laws and practices.
300e–11.
Continued regulation of health maintenance organizations.
300e–12.
Limitation on source of funding for
health maintenance organizations.
300e–13.
Repealed.
300e–14.
Annual report.
300e–14a.
Health services for Indians and domestic
agricultural migratory and seasonal
workers.
300e–15.
Repealed.
300e–16.
Training and technical assistance.
300e–17.
Financial disclosure.
SUBCHAPTER XII—SAFETY OF PUBLIC WATER
SYSTEMS
PART A—DEFINITIONS
300f.

Grants to States.

Definitions.
PART B—PUBLIC WATER SYSTEMS

300g.
300g–1.
300g–2.
300g–3.
300g–4.
300g–5.
300g–6.
300g–7.
300g–8.
300g–9.

Coverage.
National drinking water regulations.
State primary enforcement responsibility.
Enforcement of drinking water regulations.
Variances.
Exemptions.
Prohibition on use of lead pipes, solder,
and flux.
Monitoring of contaminants.
Operator certification.
Capacity development.

PART C—PROTECTION OF UNDERGROUND SOURCES OF
DRINKING WATER
300h.
300h–1.
300h–2.
300h–3.
300h–4.
300h–5.
300h–6.
300h–7.
300h–8.

Regulations for State programs.
State primary enforcement responsibility.
Enforcement of program.
Interim regulation of underground injections.
Optional demonstration by States relating to oil or natural gas.
Regulation of State programs.
Sole source aquifer demonstration program.
State programs to establish wellhead
protection areas.
State ground water protection grants.
PART D—EMERGENCY POWERS

Establishment of Program.
PART G—POISON CONTROL

300d–71.

300d–82.
Authorization of appropriations.
SUBCHAPTER XI—HEALTH MAINTENANCE
ORGANIZATIONS

300i.
300i–1.
300i–2.
300i–3.
300i–4.

Emergency powers.
Tampering with public water systems.
Terrorist and other intentional acts.
Contaminant prevention, detection and
response.
Supply disruption prevention, detection
and response.
PART E—GENERAL PROVISIONS

300j.

Assurances of availability of adequate
supplies of chemicals necessary for
treatment of water.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

300j–1.
300j–2.
300j–3.
300j–3a.
300j–3b.
300j–3c.
300j–4.
300j–5.
300j–6.
300j–7.
300j–8.
300j–9.
300j–10.

300j–11.
300j–12.
300j–13.
300j–14.
300j–15.
300j–16.
300j–17.
300j–18.

Research, technical assistance, information, training of personnel.
Grants for State programs.
Special project grants and guaranteed
loans.
Grants to public sector agencies.
Contaminant standards or treatment
technique guidelines.
National assistance program for water
infrastructure and watersheds.
Records and inspections.
National Drinking Water Advisory Council.
Federal agencies.
Judicial review.
Citizen’s civil action.
General provisions.
Appointment of scientific, etc., personnel by Administrator of Environmental Protection Agency for implementation of responsibilities; compensation.
Indian Tribes.
State revolving loan funds.
Source water quality assessment.
Source water petition program.
Water conservation plan.
Assistance to colonias.
Estrogenic substances screening program.
Drinking water studies.

PART F—ADDITIONAL REQUIREMENTS TO REGULATE
SAFETY OF DRINKING WATER
300j–21.
300j–22.

PART C—GENERAL PROVISIONS
300s.
300s–1.
300s–1a.
300s–2.
300s–3.
300s–4.
300s–5.

300s–6.

PART D—AREA HEALTH SERVICES DEVELOPMENT FUNDS
300t.

300t–11.
300t–12.
300t–13.
300t–14.

SUBCHAPTER XIII—PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND CERVICAL CANCERS

300u–4.

300j–26.

300k.
300l.
300l–1.
300m.
300n.
300n–1.
300n–2.
300n–3.

300n–4.
300n–4a.
300n–5.

Establishment of program of grants to
States.
Requirement of matching funds.
Requirement regarding medicaid.
Requirements with respect to type and
quality of services.
Additional required agreements.
Description of intended uses of grant.
Requirement of submission of application.
Technical assistance and provision of
supplies and services in lieu of grant
funds.
Evaluations and reports.
Supplemental grants for additional preventive health services.
Funding for general program.

300u–2.
300u–3.

300u–5.

300u–6.
300u–6a.
300u–7.
300u–8.
300u–9.
300u–10.
300u–11.
300u–12.
300u–13.
300u–14.

SUBCHAPTER XIV—HEALTH RESOURCES
DEVELOPMENT
300o to 300p–3. Repealed.

300u–15.

PART A—LOANS AND LOAN GUARANTEES
300q.
300q–1.
300q–2.

Loan and loan guarantee authority.
Repealed.
General provisions.

300r.

Grants for construction or modernization projects.

PART B—PROJECT GRANTS

Grants and assistance for establishment
of program.
Grants for discontinuance and conversion.
Grants to States for reduction of excess
hospital capacity.
Authorization of appropriations.

SUBCHAPTER XV—HEALTH INFORMATION AND
HEALTH PROMOTION
300u.
300u–1.

300j–25.

Development grants for health systems
agencies.

PART E—PROGRAM TO ASSIST AND ENCOURAGE VOLUNTARY DISCONTINUANCE OF UNNEEDED HOSPITAL
SERVICES AND CONVERSION OF UNNEEDED HOSPITAL
SERVICES TO OTHER HEALTH SERVICES NEEDED BY
COMMUNITY

Definitions.
Recall of drinking water coolers with
lead-lined tanks.
Drinking water coolers containing lead.
Lead contamination in school drinking
water.
Federal assistance for State programs
regarding lead contamination in school
drinking water.
Certification of testing laboratories.

300j–23.
300j–24.

General regulations.
Medical facility project applications.
Recovery of expenditures under certain
conditions.
State supervision or control of operations of facilities receiving funds.
Definitions.
Reporting and audit requirements for recipients.
Availability of technical and other nonfinancial assistance to eligible applicants.
Enforcement of assurances.

General authority of Secretary.
Grants and contracts for research programs; authority of Secretary; review
of applications; additional functions;
periodic public survey.
Grants and contracts for community
health programs.
Grants and contracts for information
programs; authority of Secretary; particular activities.
Status reports to President and Congress; study of health education and
preventive health services with respect
to insurance coverage.
Centers for research and demonstration
of health promotion and disease prevention.
Office of Minority Health.
Individual offices of minority health
within the Department.
Office of Adolescent Health.
Biennial report regarding nutrition and
health.
Education regarding DES.
National Prevention, Health Promotion
and Public Health Council.
Prevention and Public Health Fund.
Education and outreach campaign regarding preventive benefits.
Community transformation grants.
Healthy aging, living well; evaluation of
community-based
prevention
and
wellness programs for Medicare beneficiaries.
Research on optimizing the delivery of
public health services.

SUBCHAPTER
XVI—PRESIDENT’S
COMMISSION
FOR THE STUDY OF ETHICAL PROBLEMS IN
MEDICINE AND BIOMEDICAL AND BEHAVIOR
RESEARCH
300v.
300v–1.
300v–2.

Commission.
Duties of Commission.
Administrative provisions.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Page 28

Sec.

300v–3.

Authorization of appropriations; termination of Commission.
SUBCHAPTER XVII—BLOCK GRANTS

PART A—PREVENTIVE HEALTH AND HEALTH SERVICES
BLOCK GRANTS
300w.
300w–1.
300w–2.
300w–3.
300w–4.
300w–5.
300w–6.
300w–7.
300w–8.
300w–9.
300w–10.

Authorization of appropriations.
Allotments.
Payments under allotments to States.
Use of allotments.
Application for payments; State plan.
Reports, data, and audits.
Withholding of funds.
Nondiscrimination provisions.
Criminal penalty for false statements.
Emergency medical services for children.
Repealed.

PART B—BLOCK GRANTS REGARDING MENTAL HEALTH
AND SUBSTANCE ABUSE
SUBPART I—BLOCK GRANTS FOR COMMUNITY MENTAL
HEALTH SERVICES

300x.
300x–1.
300x–2.
300x–3.
300x–4.
300x–5.
300x–6.
300x–7.
300x–8.
300x–9.

Formula grants to States.
State plan for comprehensive community mental health services for certain
individuals.
Certain agreements.
State mental health planning council.
Additional provisions.
Restrictions on use of payments.
Application for grant.
Determination of amount of allotment.
Definitions.
Funding.

SUBPART II—BLOCK GRANTS FOR PREVENTION AND
TREATMENT OF SUBSTANCE ABUSE

300x–21.
300x–22.
300x–23.
300x–24.
300x–25.
300x–26.
300x–26a.
300x–27.
300x–28.
300x–29.
300x–30.
300x–31.
300x–32.
300x–33.
300x–34.
300x–35.

Formula grants to States.
Certain allocations.
Intravenous substance abuse.
Requirements regarding tuberculosis and
human immunodeficiency virus.
Group homes for recovering substance
abusers.
State law regarding sale of tobacco products to individuals under age of 18.
Withholding of substance abuse funding
under section 300x–26.
Treatment services for pregnant women.
Additional agreements.
Submission to Secretary of statewide assessment of needs.
Maintenance of effort regarding State
expenditures.
Restrictions on expenditure of grant.
Application for grant; approval of State
plan.
Determination of amount of allotment.
Definitions.
Funding.

300x–61.
300x–62.
300x–63.
300x–64.
300x–65.
300x–66.

PART C—CERTAIN PROGRAMS REGARDING MENTAL
HEALTH AND SUBSTANCE ABUSE
SUBPART I—DATA INFRASTRUCTURE DEVELOPMENT

300y.

300x–52.
300x–53.
300x–54.
300x–55.
300x–56.
300x–57.
300x–58.

300x–59.
300x–60.

Opportunity for public comment on
State plans.
Requirement of reports and audits by
States.
Additional requirements.
Disposition of certain funds appropriated
for allotments.
Failure to comply with agreements.
Prohibitions regarding receipt of funds.
Nondiscrimination.
Technical assistance and provision of
supplies and services in lieu of grant
funds.
Plans for performance partnerships.
Rule of construction regarding delegation of authority to States.

Data infrastructure development.

SUBPART II—INTERIM MAINTENANCE TREATMENT OF
NARCOTICS DEPENDENCE

300y–11.

Interim maintenance treatment.

SUBCHAPTER XVIII—ADOLESCENT FAMILY LIFE
DEMONSTRATION PROJECTS
300z.
300z–1.
300z–2.
300z–3.
300z–4.
300z–5.
300z–6.
300z–7.
300z–8.
300z–9.
300z–10.

Findings and purposes.
Definitions; regulations applicable.
Demonstration projects; grant authorization, etc.
Uses of grants for demonstration projects for services.
Grants for demonstration projects for
services.
Requirements for applications.
Coordination of programs.
Research.
Evaluation and administration.
Authorization of appropriations.
Restrictions.
SUBCHAPTER XIX—VACCINES
PART 1—NATIONAL VACCINE PROGRAM

300aa–1.
300aa–2.
300aa–3.
300aa–4.
300aa–5.
300aa–6.

Establishment.
Program responsibilities.
Plan.
Repealed.
National Vaccine Advisory Committee.
Authorization of appropriations.

PART 2—NATIONAL VACCINE INJURY COMPENSATION
PROGRAM
SUBPART A—PROGRAM REQUIREMENTS

300aa–10.
300aa–11.
300aa–12.
300aa–13.
300aa–14.
300aa–15.
300aa–16.
300aa–17.
300aa–18.
300aa–19.

SUBPART III—GENERAL PROVISIONS

300x–51.

Solicitation of views of certain entities.
Availability to States of grant payments.
Continuation of certain programs.
Definitions.
Services provided by nongovernmental
organizations.
Services for individuals with co-occurring disorders.

Establishment of program.
Petitions for compensation.
Court jurisdiction.
Determination of eligibility and compensation.
Vaccine Injury Table.
Compensation.
Limitations of actions.
Subrogation.
Repealed.
Advisory Commission on Childhood Vaccines.
SUBPART B—ADDITIONAL REMEDIES

300aa–21.
300aa–22.
300aa–23.

Authority to bring actions.
Standards of responsibility.
Trial.

SUBPART C—ASSURING A SAFER CHILDHOOD VACCINATION
PROGRAM IN UNITED STATES

300aa–25.
300aa–26.
300aa–27.
300aa–28.

Recording and reporting of information.
Vaccine information.
Mandate for safer childhood vaccines.
Manufacturer recordkeeping and reporting.
SUBPART D—GENERAL PROVISIONS

300aa–31.

Citizen’s actions.

Page 29

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

Sec.

300aa–32.
Judicial review.
300aa–33.
Definitions.
300aa–34.
Termination of program.
SUBCHAPTER XX—REQUIREMENTS FOR CERTAIN
GROUP HEALTH PLANS FOR CERTAIN STATE
AND LOCAL EMPLOYEES
State and local governmental group
health plans must provide continuation coverage to certain individuals.
300bb–2.
Continuation coverage.
300bb–3.
Qualifying event.
300bb–4.
Applicable premium.
300bb–5.
Election.
300bb–6.
Notice requirements.
300bb–7.
Enforcement.
300bb–8.
Definitions.
SUBCHAPTER XXI—RESEARCH WITH RESPECT TO
ACQUIRED IMMUNE DEFICIENCY SYNDROME

PART B—SUBACUTE CARE
300dd–21.

PART C—OTHER HEALTH SERVICES
300dd–31.
300dd–32.

300bb–1.

300dd–33.
300dd–41.

Repealed.
Requirement of expediting awards of
grants and contracts for research.
Requirements with respect to processing
of requests for personnel and administrative support.
Establishment of Research Advisory
Committee.

300cc–2.

300cc–3.

300ee.
300ee–1.

Clinical evaluation units at National Institutes of Health.
Use of investigational new drugs with respect to acquired immune deficiency
syndrome.
Terry Beirn Community-Based AIDS Research Initiative.
Evaluation of certain treatments.
Support of international efforts.
Research centers.
Information services.
Development of model protocols for clinical care of infected individuals.
National blood resource education program.
Additional authority with respect to research.

300cc–12.

300cc–13.
300cc–14.
300cc–15.
300cc–16.
300cc–17.
300cc–18.
300cc–19.
300cc–20.

PART C—RESEARCH TRAINING
300cc–31.

Fellowships and training.

300ee–2.
300ee–3.
300ee–4.
300ee–5.

300ee–6.

PART A—FORMULA GRANTS TO STATES
300ee–11.
300ee–12.
300ee–13.

300ee–14.
300ee–15.
300ee–16.
300ee–17.
300ee–18.
300ee–19.
300ee–20.

300ee–21.
300ee–22.
300ee–23.
300ee–24.

PART D—OFFICE OF AIDS RESEARCH
SUBPART I—INTERAGENCY COORDINATION OF ACTIVITIES

300ee–32.
300ee–33.

300cc–40c.
300cc–41.

Establishment of Office.
Microbicide research.
Advisory Council; coordinating committees.
Comprehensive plan for expenditure of
appropriations.
Additional authorities.

SUBPART II—EMERGENCY DISCRETIONARY FUND

300cc–43.

Emergency Discretionary Fund.

300ee–34.

General provisions regarding Office.
PART E—GENERAL PROVISIONS

300cc–51.
Definitions.
SUBCHAPTER XXII—HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME
PART A—FORMULA GRANTS TO STATES FOR HOME AND
COMMUNITY-BASED HEALTH SERVICES
300dd to 300dd–14. Repealed.

Availability of information to general
public.
Public information campaigns.
Provision of information to underserved
populations.
Authorization of appropriations.

SUBCHAPTER XXIV—HIV HEALTH CARE
SERVICES PROGRAM
300ff.
300ff–1.

Purpose.
Prohibition on use of funds.

PART A—EMERGENCY RELIEF FOR AREAS WITH
SUBSTANTIAL NEED FOR SERVICES

SUBPART III—GENERAL PROVISIONS

300cc–45.

Establishment of program.
Provisions with respect to carrying out
purpose of grants.
Requirement of submission of application containing certain agreements
and assurances.
Restrictions on use of grant.
Requirement of reports and audits by
States.
Additional required agreements.
Determination of amount of allotments
for States.
Failure to comply with agreements.
Prohibition against certain false statements.
Technical assistance and provision by
Secretary of supplies and services in
lieu of grant funds.
Evaluations.
Report by Secretary.
Definition.
Funding.

PART B—NATIONAL INFORMATION PROGRAMS
300ee–31.

300cc–40.
300cc–40a.
300cc–40b.

certain

Use of funds.
Establishment of office with respect to
minority health and acquired immune
deficiency syndrome.
Information for health and public safety
workers.
Continuing education for health care
providers.
Technical assistance.
Use of funds to supply hypodermic needles or syringes for illegal drug use;
prohibition.
Transferred.

PART B—RESEARCH AUTHORITY
300cc–11.

Grants for anonymous testing.
Requirement of provision of
counseling services.
Funding.
Transferred.

SUBCHAPTER XXIII—PREVENTION OF ACQUIRED
IMMUNE DEFICIENCY SYNDROME

PART A—ADMINISTRATION OF RESEARCH PROGRAMS
300cc.
300cc–1.

Demonstration projects.

SUBPART I—GENERAL GRANT PROVISIONS

300ff–11.
300ff–12.
300ff–13.
300ff–14.
300ff–15.
300ff–16.
300ff–17.
300ff–18.

Establishment of program of grants.
Administration and planning council.
Type and distribution of grants.
Use of amounts.
Application.
Technical assistance.
Definitions.
Repealed.
SUBPART II—TRANSITIONAL GRANTS

300ff–19.

Establishment of program.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Page 30

Sec.
SUBPART III—GENERAL PROVISIONS

300ff–20.

300ff–87.
300ff–87a.
300ff–88.

Authorization of appropriations.
PART B—CARE GRANT PROGRAM

PART F—DEMONSTRATION AND TRAINING

SUBPART I—GENERAL GRANT PROVISIONS

300ff–21.
300ff–22.
300ff–23.
300ff–24.
300ff–25.
300ff–26.
300ff–27.
300ff–27a.
300ff–28.
300ff–29.
300ff–29a.
300ff–30.
300ff–31.
300ff–31a.
300ff–31b.

Grants.
General use of grants.
Grants to establish HIV care consortia.
Grants for home- and community-based
care.
Continuum of health insurance coverage.
Provision of treatments.
State application.
Spousal notification.
Distribution of funds.
Technical assistance.
Supplemental grants.
Emerging communities.
Repealed.
Timeframe for obligation and expenditure of grant funds.
Authorization of appropriations.

SUBPART II—PROVISIONS CONCERNING PREGNANCY AND
PERINATAL TRANSMISSION OF HIV

300ff–33.
300ff–34.

Early diagnosis grant program.
Perinatal transmission of HIV/AIDS;
contingent
requirement
regarding
State grants under this part.
300ff–35, 300ff–36. Repealed.
300ff–37.
State HIV testing programs established
prior to or after May 20, 1996.
300ff–37a.
Recommendations for reducing incidence
of perinatal transmission.
SUBPART III—CERTAIN PARTNER NOTIFICATION PROGRAMS

300ff–38.

Grants for
grams.

partner

notification

pro-

SUBPART I—SPECIAL PROJECTS OF NATIONAL
SIGNIFICANCE

300ff–101.

300ff–41 to 300ff–50. Repealed.
SUBPART I—CATEGORICAL GRANTS

Establishment of a program.
Minimum qualifications of grantees.
Preferences in making grants.
Miscellaneous provisions.
Authorization of appropriations.
SUBPART II—GENERAL PROVISIONS

300ff–61.
300ff–62.
300ff–63.

300ff–64.
300ff–65.

300ff–66.
300ff–67.

Confidentiality and informed consent.
Provision of certain counseling services.
Applicability of requirements regarding
confidentiality, informed consent, and
counseling.
Additional required agreements.
Requirement of submission of application containing certain agreements
and assurances.
Provision by Secretary of supplies and
services in lieu of grant funds.
Use of funds.

Grants for coordinated services and access to research for women, infants,
children, and youth.
PART E—GENERAL PROVISIONS

300ff–81.
300ff–82.
300ff–83.
300ff–84.
300ff–85.
300ff–86.

Coordination.
Audits.
Public health emergency.
Prohibition on promotion of certain activities.
Privacy protections.
GAO report.

HIV/AIDS
centers.

communities,

schools,

and

SUBPART III—MINORITY AIDS INITIATIVE

300ff–121.

Minority AIDS initiative.

PART G—NOTIFICATION OF POSSIBLE EXPOSURE TO
INFECTIOUS DISEASES
300ff–131.
300ff–132.

300ff–133.
300ff–134.
300ff–135.
300ff–136.
300ff–137.
300ff–138.
300ff–139.
300ff–140.

Infectious diseases and circumstances
relevant to notification requirements.
Routine notifications with respect to
airborne infectious diseases in victims
assisted.
Request for notification with respect to
victims assisted.
Procedures for notification of exposure.
Notification of employee.
Selection of designated officers.
Limitation with respect to duties of
medical facilities.
Miscellaneous provisions.
Injunctions regarding violation of prohibition.
Applicability of part.

SUBCHAPTER XXV—REQUIREMENTS RELATING
TO HEALTH INSURANCE COVERAGE
PART A—INDIVIDUAL AND GROUP MARKET REFORMS
SUBPART I—GENERAL REFORM

300gg.
300gg–1.
300gg–2.
300gg–3.

300gg–4.

300gg–5.
300gg–6.
300gg–7.
300gg–8.
300gg–9.

Fair health insurance premiums.
Guaranteed availability of coverage.
Guaranteed renewability of coverage.
Prohibition of preexisting condition exclusions or other discrimination based
on health status.
Prohibiting discrimination against individual participants and beneficiaries
based on health status.
Non-discrimination in health care.
Comprehensive health insurance coverage.
Prohibition on excessive waiting periods.
Coverage for individuals participating in
approved clinical trials.
Disclosure of information.
SUBPART II—IMPROVING COVERAGE

300gg–11.
300gg–12.
300gg–13.
300gg–14.
300gg–15.

PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
300ff–71.

Special projects of national significance.

SUBPART II—AIDS EDUCATION AND TRAINING CENTERS

300ff–111.

PART C—EARLY INTERVENTION SERVICES

300ff–51.
300ff–52.
300ff–53.
300ff–54.
300ff–55.

Severity of need index.
National HIV/AIDS testing goal.
Definitions.

300gg–15a.
300gg–16.
300gg–17.
300gg–18.
300gg–19.
300gg–19a.

No lifetime or annual limits.
Prohibition on rescissions.
Coverage of preventive health services.
Extension of dependent coverage.
Development and utilization of uniform
explanation of coverage documents and
standardized definitions.
Provision of additional information.
Prohibition on discrimination in favor of
highly compensated individuals.
Ensuring the quality of care.
Bringing down the cost of health care
coverage.
Appeals process.
Patient protections.

SUBPART 2—EXCLUSION OF PLANS; ENFORCEMENT;
PREEMPTION

300gg–21.

Exclusion of certain plans.

Page 31

TITLE 42—THE PUBLIC HEALTH AND WELFARE
Sec.

Sec.

300gg–22.
300gg–23.
300gg–25.
300gg–26.
300gg–27.
300gg–28.

Enforcement.
Preemption; State flexibility; construction.
Standards relating to benefits for mothers and newborns.
Parity in mental health and substance
use disorder benefits.
Required coverage for reconstructive
surgery following mastectomies.
Coverage of dependent students on medically necessary leave of absence.
PART B—INDIVIDUAL MARKET RULES

300gg–42.
300gg–43.
300gg–44.
300gg–45.

Guaranteed availability of individual
health insurance coverage to certain
individuals with prior group coverage.
Guaranteed renewability of individual
health insurance coverage.
Certification of coverage.
State flexibility in individual market reforms.
Relief for high risk pools.

300gg–52.
300gg–53.
300gg–54.

Standards relating to benefits for mothers and newborns.
Required coverage for reconstructive
surgery following mastectomies.
Prohibition of health discrimination on
the basis of genetic information.
Coverage of dependent students on medically necessary leave of absence.

Enforcement.
Preemption and application.
General exceptions.

SUBCHAPTER XXVIII—HEALTH INFORMATION
TECHNOLOGY AND QUALITY
Definitions.

PART A—PROMOTION OF HEALTH INFORMATION
TECHNOLOGY
300jj–11.
300jj–12.
300jj–13.
300jj–14.

300jj–16.

300jj–17.
300jj–18.
300jj–19.

300jj–31.

PART C—DEFINITIONS; MISCELLANEOUS PROVISIONS
300gg–91.
300gg–92.
300gg–93.
300gg–94.

Definitions.
Regulations.
Health insurance consumer information.
Ensuring that consumers get value for
their dollars.
300gg–95.
Uniform fraud and abuse referral format.
SUBCHAPTER
XXVI—NATIONAL
ALL-HAZARDS
PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES
PART A—NATIONAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE PLANNING, COORDINATING, AND REPORTING

300jj–32.
300jj–33.
300jj–34.

300jj–35.

300jj–36.

Public health and medical preparedness
and response functions.
National Health Security Strategy.
Enhancing medical surge capacity.

300jj–37.
300jj–38.

PART B—ALL-HAZARDS EMERGENCY PREPAREDNESS AND
RESPONSE

300jj–51.

300hh.
300hh–1.
300hh–2.

300hh–10.
300hh–11.
300hh–12.
300hh–13.
300hh–14.
300hh–15.
300hh–16.
300hh–17.

Coordination of preparedness for and response to all-hazards public health
emergencies.
National Disaster Medical System.
Transferred.
Evaluation of new and emerging technologies regarding bioterrorist attack
and other public health emergencies.
Protection of health and safety during
disasters.
Volunteer Medical Reserve Corps.
At-risk individuals.
Emergency response coordination of primary care providers.

PART C—STRENGTHENING PUBLIC HEALTH
SURVEILLANCE SYSTEMS
300hh–31.

Epidemiology-laboratory
grants.

Definitions.
Lifespan respite care grants and cooperative agreements.
National lifespan respite resource center.
Report.
Authorization of appropriations.

Office of the National Coordinator for
Health Information Technology.
HIT Policy Committee.
HIT Standards Committee.
Process for adoption of endorsed recommendations; adoption of initial set of
standards, implementation specifications, and certification criteria.
Application and use of adopted standards
and implementation specifications by
Federal agencies.
Voluntary application and use of adopted standards and implementation specifications by private entities.
Federal health information technology.
Transitions.
Miscellaneous provisions.

PART B—INCENTIVES FOR THE USE OF HEALTH
INFORMATION TECHNOLOGY

SUBPART 3—GENERAL PROVISIONS

300gg–61.
300gg–62.
300gg–63.

300ii–3.
300ii–4.

300jj–15.

SUBPART 2—OTHER REQUIREMENTS

300gg–51.

300ii–2.

300jj.

SUBPART 1—PORTABILITY, ACCESS, AND RENEWABILITY
REQUIREMENTS

300gg–41.

SUBCHAPTER XXVII—LIFESPAN RESPITE CARE
300ii.
300ii–1.

capacity

Immediate funding to strengthen the
health information technology infrastructure.
Health information technology implementation assistance.
State grants to promote health information technology.
Competitive grants to States and Indian
tribes for the development of loan programs to facilitate the widespread
adoption of certified EHR technology.
Demonstration program to integrate information technology into clinical
education.
Information technology professionals in
health care.
General grant and loan provisions.
Authorization for appropriations.
PART C—OTHER PROVISIONS
Health information technology enrollment standards and protocols.

SUBCHAPTER XXIX—DATA COLLECTION,
ANALYSIS, AND QUALITY
300kk.

Data collection, analysis, and quality.

SUBCHAPTER XXX—COMMUNITY LIVING
ASSISTANCE SERVICES AND SUPPORTS
300ll.
300ll–1.
300ll–2.
300ll–3.
300ll–4.
300ll–5.
300ll–6.
300ll–7.
300ll–8.
300ll–9.

Purpose.
Definitions.
CLASS Independence Benefit Plan.
Enrollment and disenrollment requirements.
Benefits.
CLASS Independence Fund.
CLASS Independence Advisory Council.
Solvency and fiscal independence; regulations; annual report.
Inspector General’s report.
Tax treatment of program.

§ 201

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sec.

SUBCHAPTER XXXI—WORLD TRADE CENTER
HEALTH PROGRAM
PART A—ESTABLISHMENT OF PROGRAM; ADVISORY
COMMITTEE
300mm.

Establishment of World Trade Center
Health Program.
WTC Health Program Scientific/Technical
Advisory
Committee;
WTC
Health Program Steering Committees.
Education and outreach.
Uniform data collection and analysis.
Clinical Centers of Excellence and Data
Centers.
Definitions.

300mm–1.
300mm–2.
300mm–3.
300mm–4.
300mm–5.

PART B—PROGRAM OF MONITORING, INITIAL HEALTH
EVALUATIONS, AND TREATMENT
SUBPART 1—WTC RESPONDERS

300mm–21.
300mm–22.
300mm–23.

Identification of WTC responders and
provision of WTC-related monitoring
services.
Treatment of enrolled WTC responders
for WTC-related health conditions.
National arrangement for benefits for eligible individuals outside New York.
SUBPART 2—WTC SURVIVORS

300mm–31.
300mm–32.
300mm–33.

Identification and initial health evaluation of screening-eligible and certifiedeligible WTC survivors.
Followup monitoring and treatment of
certified-eligible WTC survivors for
WTC-related health conditions.
Followup monitoring and treatment of
other individuals with WTC-related
health conditions.
SUBPART 3—PAYOR PROVISIONS

300mm–41.
300mm–42.

Payment of claims.
Administrative arrangement authority.

PART C—RESEARCH INTO CONDITIONS
300mm–51.
300mm–52.

Research regarding certain health conditions related to September 11 terrorist
attacks.
World Trade Center Health Registry.
PART D—FUNDING

300mm–61.

World Trade Center Health Program
Fund.

SUBCHAPTER I—ADMINISTRATION AND
MISCELLANEOUS PROVISIONS
§ 201. Definitions
When used in this chapter—
(a) The term ‘‘Service’’ means the Public
Health Service;
(b) The term ‘‘Surgeon General’’ means the
Surgeon General of the Public Health Service;
(c) Unless the context otherwise requires, the
term ‘‘Secretary’’ means the Secretary of
Health and Human Services.
(d) The term ‘‘regulations’’, except when
otherwise specified, means rules and regulations
made by the Surgeon General with the approval
of the Secretary;
(e) The term ‘‘executive department’’ means
any executive department, agency, or independent establishment of the United States or any
corporation wholly owned by the United States;
(f) Except as provided in sections 246(g)(4)(B),1
247c(c)(1),1 254d(h)(3),1 263c(5),1 264(d), 292a(9),1
1 See

References in Text note below.

Page 32

300a(c), 300f(13), and 300n(1) 1 of this title, the
term ‘‘State’’ includes, in addition to the several States, only the District of Columbia,
Guam, the Commonwealth of Puerto Rico, the
Northern Mariana Islands, the Virgin Islands,
American Samoa, and the Trust Territory of the
Pacific Islands.
(g) The term ‘‘possession’’ includes, among
other possessions, Puerto Rico and the Virgin Islands;
(h) Repealed. Pub. L. 97–35, title IX, § 986(a),
Aug. 13, 1981, 95 Stat. 603.
(i) The term ‘‘vessel’’ includes every description of watercraft or other artificial contrivance
used, or capable of being used, as a means of
transportation on water, exclusive of aircraft
and amphibious contrivances;
(j) The term ‘‘habit-forming narcotic drug’’ or
‘‘narcotic’’ means opium and coca leaves and the
several alkaloids derived therefrom, the best
known of these alkaloids being morphia, heroin,
and codeine, obtained from opium, and cocaine
derived from the coca plant; all compounds,
salts, preparations, or other derivatives obtained either from the raw material or from the
various alkaloids; Indian hemp and its various
derivatives, compounds, and preparations, and
peyote in its various forms; isonipecaine and its
derivatives, compounds, salts, and preparations;
opiates (as defined in section 4731(g) 1 of title 26);
(k) The term ‘‘addict’’ means any person who
habitually uses any habit-forming narcotic
drugs so as to endanger the public morals,
health, safety, or welfare, or who is or has been
so far addicted to the use of such habit-forming
narcotic drugs as to have lost the power of selfcontrol with reference to his addiction;
(l) The term ‘‘psychiatric disorders’’ includes
diseases of the nervous system which affect
mental health;
(m) The term ‘‘State mental health authority’’ means the State health authority, except
that, in the case of any State in which there is
a single State agency, other than the State
health authority, charged with responsibility
for administering the mental health program of
the State, it means such other State agency;
(n) The term ‘‘heart diseases’’ means diseases
of the heart and circulation;
(o) The term ‘‘dental diseases and conditions’’
means diseases and conditions affecting teeth
and their supporting structures, and other related diseases of the mouth; and
(p) The term ‘‘uniformed service’’ means the
Army, Navy, Air Force, Marine Corps, Coast
Guard, Public Health Service, or National Oceanic and Atmospheric Administration.
(q) The term ‘‘drug dependent person’’ means a
person who is using a controlled substance (as
defined in section 802 of title 21) and who is in a
state of psychic or physical dependence, or both,
arising from the use of that substance on a continuous basis. Drug dependence is characterized
by behavioral and other responses which include
a strong compulsion to take the substance on a
continuous basis in order to experience its psychic effects or to avoid the discomfort caused by
its absence.
(July 1, 1944, ch. 373, title I, § 2, 58 Stat. 682; July
3, 1946, ch. 538, § 3, 60 Stat. 421; Feb. 28, 1948, ch.
83, § 1, 62 Stat. 38; June 16, 1948, ch. 481, § 6(a), 62

Page 33

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 469; June 24, 1948, ch. 621, § 6(a), 62 Stat. 601;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 86–70, § 31(a), June
25, 1959, 73 Stat. 148; Pub. L. 86–415, § 5(a), Apr. 8,
1960, 74 Stat. 34; Pub. L. 86–624, § 29(a), July 12,
1960, 74 Stat. 419; 1965 Reorg. Plan No. 2, eff. July
13, 1965, 30 F.R. 8819, 79 Stat. 1318; Pub. L. 91–212,
§ 11, Mar. 13, 1970, 84 Stat. 67; 1970 Reorg. Plan
No. 4, eff. Oct. 3, 1970, 35 F.R. 15627, 84 Stat. 2090;
Pub. L. 91–513, title I, § 2(b), Oct. 27, 1970, 84 Stat.
1240; Pub. L. 93–523, § 2(b), Dec. 16, 1974, 88 Stat.
1693; Pub. L. 94–317, title III, § 301(a), June 23,
1976, 90 Stat. 707; Pub. L. 94–484, title IX, § 905(a),
Oct. 12, 1976, 90 Stat. 2325; Pub. L. 95–83, title I,
§ 107, Aug. 1, 1977, 91 Stat. 386; Pub. L. 96–79, title
II, § 203(e)(2), Oct. 4, 1979, 93 Stat. 635; Pub. L.
97–35, title IX, §§ 902(d)(5), 986(a), Aug. 13, 1981, 95
Stat. 560, 603; Pub. L. 103–43, title XX, § 2008(e),
June 10, 1993, 107 Stat. 212.)
REFERENCES IN TEXT
Section 246(g) of this title, referred to in subsec. (f),
was repealed by Pub. L. 96–398, title I, § 107(d), Oct. 7,
1980, 94 Stat. 1571.
Section 247c(c)(1) of this title, referred to in subsec.
(f), was repealed by Pub. L. 94–317, title II, § 203(f)(1),
June 23, 1976, 90 Stat. 704.
Section 254d(h)(3) of this title, referred to in subsec.
(f), was redesignated section 254d(i)(4) of this title by
Pub. L. 100–177, title II, § 202(b)(5), title III, § 301(1), Dec.
1, 1987, 101 Stat. 996, 1003, and was subsequently redesignated section 254d(j)(4) of this title by Pub. L. 107–251,
title III, § 301(b)(1), Oct. 26, 2002, 116 Stat. 1643.
Section 263c(5) of this title, referred to in subsec. (f),
was in the original a reference to section 355(5) of the
Public Health Service Act which was redesignated section 531(5) of the Federal Food, Drug, and Cosmetic Act
by Pub. L. 101–629, § 19(a)(3), Nov. 28, 1990, 104 Stat. 4530,
and is now classified to section 360hh(5) of Title 21,
Food and Drugs.
Section 292a of this title, referred to in subsec. (f),
contained definitions for purposes of subchapter V of
this chapter prior to the general revision of subchapter
V by Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106 Stat.
1994. See sections 292o and 295p of this title.
Section 300n of this title, referred to in subsec. (f),
was repealed by Pub. L. 99–660, title VII, § 701(a), Nov.
14, 1986, 100 Stat. 3799.
Section 4731(g) of title 26, referred to in subsec. (j),
was repealed by Pub. L. 91–513, title III, § 1101(b)(3)(A),
Oct. 27, 1970, 84 Stat. 1292. A definition of ‘‘opiate’’ is
contained in section 102 of Pub. L. 91–513, which is classified to section 802 of Title 21, Food and Drugs. Reference to section 4731(g) of title 26 was substituted for
‘‘section 3228(f) of title 26’’ on authority of section
7852(b) of Title 26, Internal Revenue Code, which provides that a reference in other laws to the Internal
Revenue Code of 1939 is deemed a reference to the corresponding provision of the Internal Revenue Code of
1986.
CODIFICATION
Section was enacted as part of title I of act July 1,
1944, ch. 373, 58 Stat. 682, and not as part of title II of
such Act which comprises this subchapter.
AMENDMENTS
1993—Subsec. (c). Pub. L. 103–43 substituted ‘‘Health
and Human Services’’ for ‘‘Health, Education, and Welfare’’.
1981—Subsec. (f). Pub. L. 97–35, § 902(d)(5), struck out
reference to section 300d(2) of this title.
Subsec. (h). Pub. L. 97–35, § 986(a), struck out subsec.
(h) which defined ‘‘seamen’’.
1979—Subsec. (f). Pub. L. 96–79 struck out from enumeration of excepted sections reference to section
300s–3(1) of this title.

§ 201

1977—Subsec. (f). Pub. L. 95–83 expanded definition of
‘‘State’’ to include American Samoa and the Trust Territory of the Pacific Islands.
1976—Subsec. (f). Pub. L. 94–484 amended subsec. (f)
generally.
Pub. L. 94–317 substituted provisions defining, with
certain specific exceptions, ‘‘State’’ to include the several States, the District of Columbia, Guam, Puerto
Rico and the Virgin Islands for provisions defining
‘‘State’’ to include a State or the District of Columbia,
Puerto Rico, or the Virgin Islands, except in section
264(d) of this title such term means a State or the District of Columbia, and in subchapter XII of this chapter
such term includes Guam, American Samoa, and the
Trust Territory of the Pacific Islands.
1974—Subsec. (f). Pub. L. 93–523 designated existing
provisions as cl. (1) and added cl. (2).
1970—Subsec. (c). Pub. L. 91–212 amended subsec. (c)
generally. Prior to amendment, subsec. (c) read as follows: ‘‘The term ‘Administrator’ means the Federal Security Administrator;’’.
Subsec. (q). Pub. L. 91–513 added subsec. (q).
1960—Subsec. (f). Pub. L. 86–624 struck out ‘‘Hawaii,’’
before ‘‘Puerto Rico’’.
Subsec. (p). Pub. L. 86–415 added subsec. (p).
1959—Subsec. (f). Pub. L. 86–70 struck out ‘‘Alaska,’’
after ‘‘Hawaii,’’ and substituted ‘‘or the District of Columbia’’ for ‘‘, the District of Columbia, or Alaska’’.
1948—Subsec. (j). Act Feb. 28, 1948, inserted ‘‘isonipecaine and its derivatives, compounds, salts, and
preparations; opiates (as defined in section 4731(g) of
title 26)’’.
Subsec. (n). Act June 16, 1948, added subsec. (n).
Subsec. (o). Act June 24, 1948, added subsec. (o).
1946—Subsecs. (l), (m). Act July 3, 1946, added subsecs.
(l) and (m).
CHANGE OF NAME
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services
Administration, and commissioned officers of Survey
transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff.
July 13, 1965, 30 F.R. 8819, 79 Stat. 1318, set out in the
Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 4 of 1970, eff. Oct. 3, 1970, 35
F.R. 15627, 84 Stat. 2090, abolished Environmental
Science Services Administration, established National
Oceanic and Atmospheric Administration, and redesignated Commissioned Officer Corps of ESSA as Commissioned Officer Corps of NOAA. For further details, see
Transfer of Functions note set out under section 851 of
Title 33, Navigation and Navigable Waters.
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–310, div. A, title XXIX, § 2901, Oct. 17, 2000,
114 Stat. 1168, provided that: ‘‘This division [see Tables
for classification] and the amendments made by this division take effect October 1, 2000, or upon the date of
the enactment of this Act [Oct. 17, 2000], whichever occurs later.’’
EFFECTIVE DATE OF 1993 AMENDMENT
Section 2101 of Pub. L. 103–43 provided that: ‘‘Subject
to section 203(c) [enacting provisions set out as a note
under section 283c of this title], this Act [see Short
Title of 1993 Amendment note below] and the amendments made by this Act take effect upon the date of
the enactment of this Act [June 10, 1993].’’
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by section 902(d)(5) of Pub. L. 97–35 effective Oct. 1, 1981, see section 902(h) of Pub. L. 97–35, set
out as a note under section 238l of this title.
Amendment by section 986(a) of Pub. L. 97–35 effective Oct. 1, 1981, see section 986(c) of Pub. L. 97–35, set
out as a note under section 249 of this title.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective Oct. 1, 1979, see
section 204 of Pub. L. 96–79, set out as a note under section 300q of this title.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE OF 1970 AMENDMENT

Section 12(b) of Pub. L. 91–212 provided that: ‘‘The
amendments made by sections 10(d) and 11 [amending
this section and sections 276, 277, 278, 280, 280a–1, 280b–2
to 280b–9, and 280b–11 of this title] shall take effect on
the date of enactment of this Act [Mar. 13, 1970].’’
EFFECTIVE DATE OF 1960 AMENDMENT
Section 47(f) of Pub. L. 86–624 provided that: ‘‘The
amendments made by subsection (c), paragraphs (3) and
(4) of subsection (b), and paragraph (4) of subsection (d)
of section 14 [amending sections 15i, 15jj, 15ggg, 244, and
645 of Title 20, Education], by section 20(a) [amending
section 41 of Title 29, Labor], by section 23(b) [amending section 466j of Title 33, Navigation and Navigable
Waters], by subsections (a), (b), and (c), and paragraph
(4) of subsection (d), of section 29 [amending this section and sections 255, 264, and 291i of this title], and by
subsection (d), and paragraph (2) of subsection (c), of
section 30 [amending sections 410 and 1301 of this title]
shall become effective on August 21, 1959.’’
EFFECTIVE DATE OF 1959 AMENDMENT
Amendment by Pub. L. 86–70 effective Jan. 3, 1959, see
section 47(d) of Pub. L. 86–70.
SHORT TITLE OF 2011 AMENDMENT
Pub. L. 111–380, § 1, Jan. 4, 2011, 124 Stat. 4131, provided
that: ‘‘This Act [amending section 300g–6 of this title
and enacting provisions set out as a note under section
300g–6 of this title] may be cited as the ‘Reduction of
Lead in Drinking Water Act’.’’
Pub. L. 111–347, § 1(a), Jan. 2, 2011, 124 Stat. 3623, provided that: ‘‘This Act [enacting subchapter XXXI of
this chapter, section 5000C of Title 26, Internal Revenue
Code, and provisions set out as a note under section
5000C of Title 26 and amending provisions set out as
notes under section 1101 of Title 8, Aliens and Nationality, and section 40101 of Title 49, Transportation] may
be cited as the ‘James Zadroga 9/11 Health and Compensation Act of 2010’.’’
SHORT TITLE OF 2010 AMENDMENT
Pub. L. 111–337, § 1, Dec. 22, 2010, 124 Stat. 3588, provided that: ‘‘This Act [amending section 280g–1 of this
title] may be cited as the ‘Early Hearing Detection and
Intervention Act of 2010’.’’
Pub. L. 111–264, § 1, Oct. 8, 2010, 124 Stat. 2789, provided
that: ‘‘This Act [amending sections 274k and 274m of
this title and amending provisions set out as a note
under section 274k of this title] may be cited as the
‘Stem Cell Therapeutic and Research Reauthorization
Act of 2010’.’’
Pub. L. 111–148, title VII, § 7001(a), Mar. 23, 2010, 124
Stat. 804, provided that: ‘‘This subtitle [subtitle A
(§§ 7001–7003) of title VII of Pub. L. 111–148, amending
sections 262 and 284m of this title, sections 355, 355a,
355c, and 379g of Title 21, Food and Drugs, section 2201
of Title 28, Judiciary and Judicial Procedure, and section 271 of Title 35, Patents, and enacting provisions set
out as notes under section 262 of this title] may be
cited as the ‘Biologics Price Competition and Innovation Act of 2009’.’’
Pub. L. 111–148, title VIII, § 8001, Mar. 23, 2010, 124
Stat. 828, provided that: ‘‘This title [enacting subchapter XXX of this chapter, amending section 1396a of
this title, enacting provisions set out as notes under
section 300ll of this title, and amending provisions set
out as a note under section 1396p of this title] may be
cited as the ‘Community Living Assistance Services
and Supports Act’ or the ‘CLASS Act’.’’
Pub. L. 111–148, title X, § 10409(a), Mar. 23, 2010, 124
Stat. 978, provided that: ‘‘This section [enacting section
282d of this title and amending sections 282 and 290b of
this title] may be cited as the ‘Cures Acceleration Network Act of 2009’.’’
Pub. L. 111–148, title X, § 10410(a), Mar. 23, 2010, 124
Stat. 984, provided that: ‘‘This section [enacting section

Page 34

290bb–33 of this title] may be cited as the ‘Establishing
a Network of Health-Advancing National Centers of Excellence for Depression Act of 2009’ or the ‘ENHANCED
Act of 2009’.’’
Pub. L. 111–148, title X, § 10411(a), Mar. 23, 2010, 124
Stat. 988, provided that: ‘‘This subtitle [probably means
this section, enacting sections 280g–13 and 285b–8 of this
title] may be cited as the ‘Congenital Heart Futures
Act’.’’
Pub. L. 111–148, title X, § 10413(a), Mar. 23, 2010, 124
Stat. 990, provided that: ‘‘This section [enacting part V
of subchapter II of this chapter] may be cited as the
‘Young Women’s Breast Health Education and Awareness Requires Learning Young Act of 2009’ or the
‘EARLY Act’.’’
SHORT TITLE OF 2009 AMENDMENT
Pub. L. 111–87, § 1(a), Oct. 30, 2009, 123 Stat. 2885, provided that: ‘‘This Act [enacting section 300ff–87a of this
title and part G of subchapter XXIV of this chapter,
amending sections 300ff–11 to 300ff–17, 300ff–19 to
300ff–27, 300ff–28, 300ff–29, 300ff–29a, 300ff–30, 300ff–31a,
300ff–31b, 300ff–33, 300ff–34, 300ff–37, 300ff–37a, 300ff–38,
300ff–51 to 300ff–55, 300ff–61 to 300ff–67, 300ff–71, 300ff–81
to 300ff–88, 300ff–101, 300ff–111, and 300ff–121 of this title,
enacting provisions set out as notes under section
300ff–11 of this title, and repealing provisions set out as
a note under section 300ff–11 of this title] may be cited
as the ‘Ryan White HIV/AIDS Treatment Extension Act
of 2009’.’’
Pub. L. 111–11, title XIV, § 14001, Mar. 30, 2009, 123
Stat. 1452, provided that: ‘‘This title [enacting sections
280g–9, 284o, and 284p of this title] may be cited as the
‘Christopher and Dana Reeve Paralysis Act’.’’
Pub. L. 111–5, div. A, title XIII, § 13001(a), Feb. 17, 2009,
123 Stat. 226, provided that: ‘‘This title [enacting subchapter XXVIII of this chapter and chapter 156 of this
title, amending sections 1320d, 1320d–5, and 1320d–6 of
this title, and enacting provisions set out as a note
under section 17931 of this title] (and title IV of division
B [amending sections 1395f, 1395r, 1395w, 1395w–4,
1395w–21, 1395w–23, 1395ww, 1395iii, and 1396b of this
title, enacting provisions set out as a note under section 1395ww of this title, and amending provisions set
out as notes under section 1395ww of this title]) may be
cited as the ‘Health Information Technology for Economic and Clinical Health Act’ or the ‘HITECH Act’.’’
SHORT TITLE OF 2008 AMENDMENT
Pub. L. 110–426, § 1, Oct. 15, 2008, 122 Stat. 4835, provided that: ‘‘This Act [amending section 274 of this title
and enacting provisions set out as a note under section
274 of this title] may be cited as the ‘Stephanie Tubbs
Jones Organ Transplant Authorization Act of 2008’.’’
Pub. L. 110–413, § 1, Oct. 14, 2008, 122 Stat. 4338, provided that: ‘‘This Act [enacting sections 274i to 274i–4 of
this title] may be cited as the ‘Stephanie Tubbs Jones
Gift of Life Medal Act of 2008’.’’
Pub. L. 110–392, § 1(a), Oct. 13, 2008, 122 Stat. 4195, provided that: ‘‘This Act [enacting section 285b–7c of this
title, amending section 247b–6 of this title, and enacting provisions set out as notes under sections 247b–6
and 264 of this title] may be cited as the ‘Comprehensive Tuberculosis Elimination Act of 2008’.’’
Pub. L. 110–381, § 1, Oct. 9, 2008, 122 Stat. 4081, provided
that: ‘‘This Act [enacting sections 300gg–7 and 300gg–54
of this title, section 9813 of Title 26, Internal Revenue
Code, and section 1185c of Title 29, Labor, and enacting
provisions set out as a note under section 9813 of Title
26] may be cited as ‘Michelle’s Law’.’’
Pub. L. 110–377, § 1, Oct. 8, 2008, 122 Stat. 4063, provided
that: ‘‘This Act [amending sections 300d–71 to 300d–73 of
this title and enacting provisions set out as notes
under sections 300d–71 to 300d–73 of this title] may be
cited as the ‘Poison Center Support, Enhancement, and
Awareness Act of 2008’.’’
Pub. L. 110–374, § 1, Oct. 8, 2008, 122 Stat. 4051, provided
that: ‘‘This Act [enacting section 280g–8 of this title
and provisions set out as a note under section 280g–8 of

Page 35

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this title] may be cited as the ‘Prenatally and
Postnatally Diagnosed Conditions Awareness Act’.’’
Pub. L. 110–373, § 1, Oct. 8, 2008, 122 Stat. 4047, provided
that: ‘‘This Act [enacting section 280g–7 of this title]
may be cited as the ‘ALS Registry Act’.’’
Pub. L. 110–361, § 1, Oct. 8, 2008, 122 Stat. 4010, provided
that: ‘‘This Act [amending sections 247b–18, 247b–19, and
283g of this title] may be cited as the ‘Paul D.
Wellstone Muscular Dystrophy Community Assistance,
Research, and Education Amendments of 2008’.’’
Pub. L. 110–355, § 1, Oct. 8, 2008, 122 Stat. 3988, provided
that: ‘‘This Act [enacting section 300hh–17 of this title,
amending sections 254b, 254c, 254e, 254f, 254h–1, 254k,
254q, 254q–1, 256g, and 1395x of this title, and enacting
provisions set out as notes under sections 254b and
1395x of this title] may be cited as the ‘Health Care
Safety Net Act of 2008’.’’
Pub. L. 110–354, § 1, Oct. 8, 2008, 122 Stat. 3984, provided
that: ‘‘This Act [enacting section 285a–12 of this title]
may be cited as the ‘Breast Cancer and Environmental
Research Act of 2008’.’’
Pub. L. 110–343, div. C, title V, § 511, Oct. 3, 2008, 122
Stat. 3881, provided that: ‘‘This subtitle [subtitle B
(§§ 511, 512) of title V of div. C of Pub. L. 110–343, amending section 300gg–5 of this title, section 9812 of Title 26,
Internal Revenue Code, and section 1185a of Title 29,
Labor, and enacting provisions set out as notes under
section 300gg–5 of this title] may be cited as the ‘Paul
Wellstone and Pete Domenici Mental Health Parity and
Addiction Equity Act of 2008’.’’
Pub. L. 110–339, § 1, Oct. 3, 2008, 122 Stat. 3733, provided
that: ‘‘This Act [amending section 254c–8 of this title]
may be cited as the ‘Healthy Start Reauthorization Act
of 2007’.’’
Pub. L. 110–285, § 1, July 29, 2008, 122 Stat. 2628, provided that: ‘‘This Act [enacting sections 280e–3a and
285a–11 of this title, amending section 280e–4 of this
title, and enacting provisions set out as a note under
section 280e–3a of this title] may be cited as the ‘Caroline Pryce Walker Conquer Childhood Cancer Act of
2008’.’’
Pub. L. 110–206, § 1, Apr. 28, 2008, 122 Stat. 714, provided
that: ‘‘This Act [enacting section 280b–1e of this title
and amending sections 280b–1b, 280b–1c, 280b–1d, 300d–52,
300d–53, and 300d–61 of this title] may be cited as the
‘Traumatic Brain Injury Act of 2008’.’’
Pub. L. 110–204, § 1, Apr. 24, 2008, 122 Stat. 705, as
amended by Pub. L. 110–237, § 1(b)(1), May 27, 2008, 122
Stat. 1557, provided that: ‘‘This Act [enacting sections
300b–11 to 300b–15 of this title and amending sections
300b–8 to 300b–10 of this title] may be cited as the ‘Newborn Screening Saves Lives Act of 2008’.’’
Pub. L. 110–202, § 1, Apr. 23, 2008, 122 Stat. 697, provided
that: ‘‘This Act [enacting section 280b–1f of this title]
may be cited as the ‘Safety of Seniors Act of 2007’.’’
SHORT TITLE OF 2007 AMENDMENT
Pub. L. 110–170, § 1, Dec. 26, 2007, 121 Stat. 2465, provided that: ‘‘This Act [amending sections 287a–3a and
287a–4 of this title] may be cited as the ‘Chimp Haven
is Home Act’.’’
Pub. L. 110–144, § 1, Dec. 21, 2007, 121 Stat. 1813, provided that: ‘‘This Act [enacting section 273b of this
title, amending section 274e of this title, and enacting
provisions set out as a note under section 274e of this
title] may be cited as the ‘Charlie W. Norwood Living
Organ Donation Act’.’’
Pub. L. 110–23, § 1, May 3, 2007, 121 Stat. 90, provided
that: ‘‘This Act [enacting section 300d–5 of this title,
amending sections 300d, 300d–3, 300d–12 to 300d–15,
300d–22, 300d–32, 300d–51, and 300d–52 of this title, and repealing sections 300d–2 and 300d–16 of this title] may be
cited as the ‘Trauma Care Systems Planning and Development Act of 2007’.’’
Pub. L. 110–18, § 1, Apr. 20, 2007, 121 Stat. 80, provided
that: ‘‘This Act [amending sections 300k, 300m, 300n–4,
and 300n–5 of this title] may be cited as the ‘National
Breast and Cervical Cancer Early Detection Program
Reauthorization Act of 2007’.’’
Pub. L. 109–482, § 1, Jan. 15, 2007, 120 Stat. 3675, provided that: ‘‘This Act [see Tables for classification]

§ 201

may be cited as the ‘National Institutes of Health Reform Act of 2006’.’’
Pub. L. 109–475, § 1, Jan. 12, 2007, 120 Stat. 3565, provided that: ‘‘This Act [amending section 247b–17 of this
title] may be cited as the ‘Gynecologic Cancer Education and Awareness Act of 2005’ or ‘Johanna’s Law’.’’
SHORT TITLE OF 2006 AMENDMENT
Pub. L. 109–450, § 1, Dec. 22, 2006, 120 Stat. 3341, provided that: ‘‘This Act [enacting sections 247b–4f,
247b–4g, and 280g–5 of this title, amending sections 241
and 280g–4 of this title, and enacting provisions set out
as a note under section 247b–4f of this title] may be
cited as the ‘Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act’ or
the ‘PREEMIE Act’.’’
Pub. L. 109–442, § 1, Dec. 21, 2006, 120 Stat. 3291, provided that: ‘‘This Act [enacting sections 300ii to 300ii–4
of this title] may be cited as the ‘Lifespan Respite Care
Act of 2006’.’’
Pub. L. 109–422, § 1, Dec. 20, 2006, 120 Stat. 2890, provided that: ‘‘This Act [amending section 290bb–25b of
this title] may be cited as the ‘Sober Truth on Preventing Underage Drinking Act’ or the ‘STOP Act’.’’
Pub. L. 109–417, § 1(a), Dec. 19, 2006, 120 Stat. 2831, provided that: ‘‘This Act [enacting sections 204a, 247d–7e,
247d–7f, 254u, 300hh–1, 300hh–2, 300hh–10, 300hh–15, and
300hh–16 of this title and section 360bbb–4 of Title 21,
Food and Drugs, amending sections 215, 247d–1, 247d–3a,
247d–3b, 247d–4, 247d–6, 247d–6a, 247d–6b, 247d–7b, 254d,
254q–1, 300hh, 300hh–11, and 1320b–5 of this title, sections
313, 314, and 321j of Title 6, Domestic Security, and section 8117 of Title 38, Veterans’ Benefits, repealing sections 247d–2 and 247d–3 of this title, and enacting provisions set out as notes under sections 204a, 247d–6a, 262a,
300hh–10, 300hh–11, and 1320b–5 of this title and section
313 of Title 6] may be cited as the ‘Pandemic and AllHazards Preparedness Act’.’’
Pub. L. 109–416, § 1, Dec. 19, 2006, 120 Stat. 2821, provided that: ‘‘This Act [enacting sections 280i to 280i–4
and 283j of this title, amending section 284g of this
title, and repealing sections 247b–4b to 247b–4e of this
title] may be cited as the ‘Combating Autism Act of
2006’.’’
Pub. L. 109–415, § 1(a), Dec. 19, 2006, 120 Stat. 2767, provided that: ‘‘This Act [enacting sections 300ff–19,
300ff–20, 300ff–29a, 300ff–31a, 300ff–31b, and 300ff–121 of
this title, amending sections 300ff–11 to 300ff–17, 300ff–19
to 300ff–27, 300ff–28, 300ff–29, 300ff–29a, 300ff–30, 300ff–31a,
300ff–31b, 300ff–33, 300ff–34, 300ff–37, 300ff–37a, 300ff–38,
300ff–51 to 300ff–55, 300ff–61 to 300ff–67, 300ff–71, 300ff–81
to 300ff–88, 300ff–101, 300ff–111, and 300ff–121 of this title,
and enacting provisions set out as a note under section
300ff–11 of this title] may be cited as the ‘Ryan White
HIV/AIDS Treatment Modernization Act of 2006’.’’
Pub. L. 109–307, § 1, Oct. 6, 2006, 120 Stat. 1721, provided
that: ‘‘This Act [amending section 256e of this title]
may be cited as the ‘Children’s Hospital GME Support
Reauthorization Act of 2006’.’’
Pub. L. 109–242, § 1, July 19, 2006, 120 Stat. 570, provided that: ‘‘This Act [amending section 289g–2 of this
title] may be cited as the ‘Fetus Farming Prohibition
Act of 2006’.’’
Pub. L. 109–172, § 1, Feb. 10, 2006, 120 Stat. 185, provided
that: ‘‘This Act [amending section 300gg–45 of this title]
may be cited as the ‘State High Risk Pool Funding Extension Act of 2006’.’’
SHORT TITLE OF 2005 AMENDMENTS
Pub. L. 109–148, div. C, § 1, Dec. 30, 2005, 119 Stat. 2818,
provided that: ‘‘This division [enacting sections 247d–6d
and 247d–6e of this title] may be cited as the ‘Public
Readiness and Emergency Preparedness Act’.’’
Pub. L. 109–129, § 1, Dec. 20, 2005, 119 Stat. 2550, provided that: ‘‘This Act [enacting section 274l–1 of this
title, amending sections 274k, 274l, and 274m of this
title, and enacting provisions set out as a note under
section 274k of this title] may be cited as the ‘Stem
Cell Therapeutic and Research Act of 2005’.’’

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Pub. L. 109–60, § 1, Aug. 11, 2005, 119 Stat. 1979, provided that: ‘‘This Act [enacting section 280g–3 of this
title and provisions set out as a note under section
280g–3 of this title] may be cited as the ‘National All
Schedules Prescription Electronic Reporting Act of
2005’.’’
Pub. L. 109–41, § 1(a), July 29, 2005, 119 Stat. 424, provided that: ‘‘This Act [enacting part C (§ 299b–21 et seq.)
of subchapter VII of this chapter, redesignating former
part C (§ 299c et seq.) as part D of subchapter VII of this
chapter, and amending sections 299c–6 and 299c–7 of this
title] may be cited as the ‘Patient Safety and Quality
Improvement Act of 2005’.’’
Pub. L. 109–18, § 1, June 29, 2005, 119 Stat. 340, provided
that: ‘‘This Act [enacting section 256a of this title] may
be cited as the ‘Patient Navigator Outreach and Chronic Disease Prevention Act of 2005’.’’
SHORT TITLE OF 2004 AMENDMENTS
Pub. L. 108–377, § 1, Oct. 30, 2004, 118 Stat. 2202, provided that: ‘‘This Act [amending section 280g of this
title and enacting provisions set out as notes under section 280g of this title] may be cited as the ‘Asthmatic
Schoolchildren’s Treatment and Health Management
Act of 2004’.’’
Pub. L. 108–365, § 1, Oct. 25, 2004, 118 Stat. 1738, provided that: ‘‘This Act [amending section 263b of this
title] may be cited as the ‘Mammography Quality
Standards Reauthorization Act of 2004’.’’
Pub. L. 108–362, § 1, Oct. 25, 2004, 118 Stat. 1703, provided that: ‘‘This Act [amending sections 273 and 285c–3
of this title] may be cited as the ‘Pancreatic Islet Cell
Transplantation Act of 2004’.’’
Pub. L. 108–355, § 1, Oct. 21, 2004, 118 Stat. 1404, provided that: ‘‘This Act [enacting sections 290bb–36 and
290bb–36b of this title, amending sections 290bb–34 and
290bb–36 of this title, renumbering former section
290bb–36 of this title as section 290bb–36a of this title,
and enacting provisions set out as a note under section
290bb–36 of this title] may be cited as the ‘Garrett Lee
Smith Memorial Act’.’’
Pub. L. 108–276, § 1, July 21, 2004, 118 Stat. 835, provided that: ‘‘This Act [enacting sections 247d–6a and
247d–6c of this title and section 320 of Title 6, Domestic
Security, amending sections 247d–6, 247d–6b, 287a–2,
300aa–6, and 1320b–5 of this title, sections 312 and 313 of
Title 6, and section 360bbb–3 of Title 21, Food and
Drugs, renumbering section 300hh–12 of this title as section 247d–6b of this title, enacting provisions set out as
notes under sections 247d–6a and 247d–6b of this title,
and repealing provisions set out as a note under section
1107a of Title 10, Armed Forces] may be cited as the
‘Project BioShield Act of 2004’.’’
Pub. L. 108–216, § 1, Apr. 5, 2004, 118 Stat. 584, provided
that: ‘‘This Act [enacting sections 273a and 274f–1 to
274f–4 of this title and amending sections 273 and 274f of
this title] may be cited as the ‘Organ Donation and Recovery Improvement Act’.’’
SHORT TITLE OF 2003 AMENDMENTS
Pub. L. 108–197, § 1, Dec. 19, 2003, 117 Stat. 2898, provided that: ‘‘This Act [amending section 300gg–5 of this
title and section 1185a of Title 29, Labor] may be cited
as the ‘Mental Health Parity Reauthorization Act of
2003’.’’
Pub. L. 108–194, § 1, Dec. 19, 2003, 117 Stat. 2888, provided that: ‘‘This Act [enacting part G (§ 300d–71 et seq.)
of subchapter X of this chapter, repealing chapter 142 of
this title, enacting provisions set out as a note under
section 300d–71 of this title, and repealing provisions
set out as a note under section 14801 of this title] may
be cited as the ‘Poison Control Center Enhancement
and Awareness Act Amendments of 2003’.’’
Pub. L. 108–163, § 1, Dec. 6, 2003, 117 Stat. 2020, provided
that: ‘‘This Act [enacting section 254c–18 of this title,
amending sections 233, 247b–1, 247b–6, 247c–1, 254b, 254c,
254c–14, 254c–16, 254e to 254g, 254l, 254l–1, 254o, 300e–12,
and 300ff–52 of this title, repealing section 254c–17 of
this title, enacting provisions set out as a note under

Page 36

section 233 of this title, amending provisions set out as
notes under sections 254b and 1396a of this title, and repealing provisions set out as notes under sections 254e
and 254o of this title] may be cited as the ‘Health Care
Safety Net Amendments Technical Corrections Act of
2003’.’’
Pub. L. 108–154, § 1, Dec. 3, 2003, 117 Stat. 1933, provided
that: ‘‘This Act [amending sections 247b–4 and 15022 of
this title and enacting provisions set out as notes
under sections 247b–4b and 15022 of this title] may be
cited as the ‘Birth Defects and Developmental Disabilities Prevention Act of 2003’.’’
Pub. L. 108–75, § 1, Aug. 15, 2003, 117 Stat. 898, provided
that: ‘‘This Act [enacting sections 247b–21 and 285l–6 of
this title and amending section 247b–20 of this title]
may be cited as the ‘Mosquito Abatement for Safety
and Health Act’.’’
Pub. L. 108–41, § 1, July 1, 2003, 117 Stat. 839, provided
that: ‘‘This Act [amending section 244 of this title] may
be cited as the ‘Automatic Defibrillation in Adam’s
Memory Act’.’’
Pub. L. 108–20, § 1, Apr. 30, 2003, 117 Stat. 638, provided
that: ‘‘This Act [enacting part C (§ 239 et seq.) of subchapter I of this chapter, amending section 233 of this
title, and enacting provisions set out as a note under
section 233 of this title] may be cited as the ‘Smallpox
Emergency Personnel Protection Act of 2003’.’’
SHORT TITLE OF 2002 AMENDMENTS
Pub. L. 107–313, § 1, Dec. 2, 2002, 116 Stat. 2457, provided
that: ‘‘This Act [amending section 300gg–5 of this title
and section 1185a of Title 29, Labor] may be cited as the
‘Mental Health Parity Reauthorization Act of 2002’.’’
Pub. L. 107–280, § 1, Nov. 6, 2002, 116 Stat. 1988, provided that: ‘‘This Act [enacting sections 283h and 283i of
this title and provisions set out as a note under section
283h of this title] may be cited as the ‘Rare Diseases
Act of 2002’.’’
Pub. L. 107–260, § 1, Oct. 29, 2002, 116 Stat. 1743, provided that: ‘‘This Act [amending section 280e of this
title and enacting provisions set out as a note under
section 280e of this title] may be cited as the ‘Benign
Brain Tumor Cancer Registries Amendment Act’.’’
Pub. L. 107–251, § 1(a), Oct. 26, 2002, 116 Stat. 1621, provided that: ‘‘This Act [enacting subparts V (§ 256) and X
(§ 256f et seq.) of part D of subchapter II of this chapter
and sections 254c–14 to 254c–17, 254g, and 254t of this
title, amending sections 233, 247b–1, 247b–6, 247c–1, 254b,
254c, 254d to 254f–1, 254h to 254i, 254k to 254o, 254q,
254q–1, 256d, 290cc–34, 294o, 295p, 300e–12, and 300ff–52 of
this title, repealing sections 254g and 254t of this title,
and enacting provisions set out as notes under this section and sections 254b, 254e, 254l, 254o, 256, and 1396a of
this title] may be cited as the ‘Health Care Safety Net
Amendments of 2002’.’’
Pub. L. 107–251, title II, § 211, Oct. 26, 2002, 116 Stat.
1632, provided that: ‘‘This subtitle [subtitle B (§§ 211,
212) of title II of Pub. L. 107–251, enacting section
254c–14 of this title] may be cited as the ‘Telehealth
Grant Consolidation Act of 2002’.’’
Pub. L. 107–205, § 1, Aug. 1, 2002, 116 Stat. 811, provided
that: ‘‘This Act [enacting sections 297n–1, 297w, 297x,
and 298 of this title, amending sections 294c, 296, 296p,
and 297n of this title, and enacting provisions set out as
a note under section 296 of this title] may be cited as
the ‘Nurse Reinvestment Act’.’’
Pub. L. 107–188, § 1(a), June 12, 2002, 116 Stat. 594, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘Public Health Security and Bioterrorism Preparedness and Response Act of 2002’.’’
Pub. L. 107–188, title I, § 159(a), June 12, 2002, 116 Stat.
634, provided that: ‘‘This section [enacting sections 244
and 245 of this title and provisions set out as a note
under section 244 of this title] may be cited as the
‘Community Access to Emergency Defibrillation Act of
2002’.’’
Pub. L. 107–172, § 1, May 14, 2002, 116 Stat. 541, provided
that: ‘‘This Act [enacting section 285a–10 of this title
and provisions set out as a note under section 285a–10
of this title] may be cited as the ‘Hematological Cancer
Research Investment and Education Act of 2002’.’’

Page 37

TITLE 42—THE PUBLIC HEALTH AND WELFARE
SHORT TITLE OF 2001 AMENDMENT

Pub. L. 107–84, § 1, Dec. 18, 2001, 115 Stat. 823, provided
that: ‘‘This Act [enacting sections 247b–18, 247b–19, and
283g of this title and enacting provisions set out as
notes under sections 247b–18 and 281 of this title] may
be cited as the ‘Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001’,
or the ‘MD–CARE Act’.’’
SHORT TITLE OF 2000 AMENDMENTS
Pub. L. 106–580, § 1, Dec. 29, 2000, 114 Stat. 3088, provided that: ‘‘This Act [enacting section 285r of this
title, amending section 281 of this title, and enacting
provisions set out as notes under section 285r of this
title] may be cited as the ‘National Institute of Biomedical Imaging and Bioengineering Establishment
Act’.’’
Pub. L. 106–551, § 1, Dec. 20, 2000, 114 Stat. 2752, provided that: ‘‘This Act [enacting section 287a–3a of this
title and provisions set out as a note under section
287a–3a of this title] may be cited as the ‘Chimpanzee
Health Improvement, Maintenance, and Protection
Act’.’’
Pub. L. 106–545, § 1, Dec. 19, 2000, 114 Stat. 2721, provided that: ‘‘This Act [enacting sections 285l–2 to 285l–5
of this title] may be cited as the ‘ICCVAM Authorization Act of 2000’.’’
Pub. L. 106–525, § 1(a), Nov. 22, 2000, 114 Stat. 2495, provided that: ‘‘This Act [enacting sections 287c–31 to
287c–34, 293e, 296e–1, and 299a–1 of this title, amending
sections 281, 296f, 299a, 299c–6, and 300u–6 of this title,
repealing section 283b of this title, and enacting provisions set out as notes under sections 281, 287c–31, 293e,
and 3501 of this title] may be cited as the ‘Minority
Health and Health Disparities Research and Education
Act of 2000’.’’
Pub. L. 106–505, § 1(a), Nov. 13, 2000, 114 Stat. 2314, provided that: ‘‘This Act [enacting sections 238p, 238q, 247d
to 247d–7, 254c–9 to 254c–13, 284k, 284l, 285d–6a, 285e–10a,
285f–3, 287a–4 and 288–5a of this title, amending sections
273, 274b–5, 284d, 285a–8, 285e–11, 285f–3, 287a–2 and 287a–3
of this title, repealing former section 247d of this title,
enacting provisions set out as notes under this section
and sections 238p, 254c, 273, 284k, 285d–6a, 287, 287a–2 and
289 of this title, and amending provisions set out as a
note under section 289 of this title] may be cited as the
‘Public Health Improvement Act’.’’
Pub. L. 106–505, title I, § 101, Nov. 13, 2000, 114 Stat.
2315, provided that: ‘‘This title [enacting sections 247d
to 247d–7 of this title and repealing former section 247d
of this title] may be cited as the ‘Public Health Threats
and Emergencies Act’.’’
Pub. L. 106–505, title II, § 201, Nov. 13, 2000, 114 Stat.
2325, provided that: ‘‘This title [enacting sections 284k,
284l, 287a–4 and 288a–5 of this title, amending section
284d of this title, and enacting provisions set out as
notes under section 284k of this title] may be cited as
the ‘Clinical Research Enhancement Act of 2000’.’’
Pub. L. 106–505, title III, § 301, Nov. 13, 2000, 114 Stat.
2330, provided that: ‘‘This title [enacting section 287a–2
of this title, amending section 287a–3 of this title, and
enacting provisions set out as notes under sections 287
and 287a–2 of this title] may be cited as the ‘TwentyFirst Century Research Laboratories Act’.’’
Pub. L. 106–505, title IV, § 401, Nov. 13, 2000, 114 Stat.
2336, provided that: ‘‘This subtitle [subtitle A
(§§ 401–404) of title IV of Pub. L. 106–505, enacting sections 238p and 238q of this title and provisions set out
as a note under section 238p of this title] may be cited
as the ‘Cardiac Arrest Survival Act of 2000’.’’
Pub. L. 106–505, title V, § 501, Nov. 13, 2000, 114 Stat.
2342, provided that: ‘‘This title [enacting sections 254c–9
to 254c–13 and 285d–6a of this title and provisions set
out as a note under section 285d–6a of this title] may be
cited as the ‘Lupus Research and Care Amendments of
2000’.’’
Pub. L. 106–505, title VI, § 601, Nov. 13, 2000, 114 Stat.
2345, provided that: ‘‘This title [amending sections
247b–5 and 285a–8 of this title] may be cited as the
‘Prostate Cancer Research and Prevention Act’.’’

§ 201

Pub. L. 106–505, title VII, § 701(a), Nov. 13, 2000, 114
Stat. 2346, provided that: ‘‘This section [amending section 273 of this title and enacting provisions set out as
a note under section 273 of this title] may be cited as
the ‘Organ Procurement Organization Certification Act
of 2000’.’’
Pub. L. 106–345, § 1, Oct. 20, 2000, 114 Stat. 1319, provided that: ‘‘This Act [enacting subpart III (§ 300ff–38) of
part B of subchapter XXIV of this chapter and sections
247c–2, 300ff–30, 300ff–37a, 300ff–75a, and 300ff–75b of this
title, redesignating subparts II (§ 300ff–51 et seq.) and III
(§ 300ff–61 et seq.) of part C of subchapter XXIV of this
chapter as subparts I and II, respectively, of part C of
subchapter XXIV of this chapter, amending sections
300ff–12 to 300ff–15, 300ff–21 to 300ff–23, 300ff–26 to
300ff–28, 300ff–33, 300ff–34, 300ff–37, 300ff–53 to 300ff–55,
300ff–61, 300ff–62, 300ff–64, 300ff–71, 300ff–73 to 300ff–75,
300ff–77, and 300ff–111 of this title, repealing former subpart I (§ 300ff–41 et seq.) of part C of subchapter XXIV
of this chapter and sections 300ff–31, 300ff–35, and
300ff–36 of this title, and enacting provisions set out as
notes under sections 300cc, 300ff–11, 300ff–12, and
300ff–111 of this title] may be cited as the ‘Ryan White
CARE Act Amendments of 2000’.’’
Pub. L. 106–310, § 1, Oct. 17, 2000, 114 Stat. 1101, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘Children’s Health Act of 2000’.’’
Pub. L. 106–310, div. B, § 3001, Oct. 17, 2000, 114 Stat.
1168, provided that: ‘‘This division [see Tables for classification] may be cited as the ‘Youth Drug and Mental
Health Services Act’.’’
Pub. L. 106–310, div. B, title XXXVI, § 3661, Oct. 17,
2000, 114 Stat. 1241, provided that: ‘‘This subtitle [subtitle C (§§ 3661–3665) of title XXXVI of Pub. L. 106–310,
enacting section 290aa–5b of this title and provisions
set out as notes under section 290aa–5b of this title and
section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the ‘Ecstasy Anti-Proliferation
Act of 2000’.’’
SHORT TITLE OF 1999 AMENDMENT
Pub. L. 106–129, § 1, Dec. 6, 1999, 113 Stat. 1653, provided
that: ‘‘This Act [enacting subchapter VII of this chapter and sections 254c–4 and 256e of this title, amending
sections 203, 242b, 242q–1, 286d, 288, 289c–1, 290aa,
300cc–18, 300ff–73, 1320b–12, 11221, and 11261 of this title,
enacting provisions set out as notes under sections 241,
254c, 295k, and 299 of this title, and amending provisions
set out as a note under section 299a of this title] may
be cited as the ‘Healthcare Research and Quality Act of
1999’.’’
SHORT TITLE OF 1998 AMENDMENTS
Pub. L. 105–392, § 1(a), Nov. 13, 1998, 112 Stat. 3524, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘Health Professions Education
Partnerships Act of 1998’.’’
Pub. L. 105–392, title I, § 121, Nov. 13, 1998, 112 Stat.
3562, provided that: ‘‘This subtitle [subtitle B
(§§ 121–124) of title I of Pub. L. 105–392, enacting sections
296, 296a to 296f, 296j, 296m, 296p, 297q, and 297t of this
title, transferring section 298b–2 of this title to section
296g of this title, repealing sections 296k to 296m, 296r,
297, 297–1, 297c, 298, 298a, 298b, 298b–1, 298b–3 to 298b–5,
and 298b–7 of this title, and enacting provisions set out
as notes under section 296 of this title] may be cited as
the ‘Nursing Education and Practice Improvement Act
of 1998’.’’
Pub. L. 105–392, title IV, § 419(a), Nov. 13, 1998, 112
Stat. 3591, provided that: ‘‘This section [enacting sections 280f to 280f–3 of this title and provisions set out
as a note under section 280f of this title] may be cited
as the ‘Fetal Alcohol Syndrome and Fetal Alcohol Effect Prevention and Services Act’.’’
Pub. L. 105–340, § 1, Oct. 31, 1998, 112 Stat. 3191, provided that: ‘‘This Act [enacting sections 285b–7a and
300u–9 of this title and amending sections 242k, 280e–4,
283a, 284e, 285a–8, 285e–10, 287d, 300k, 300n–4a, 300n–5, and
300u–5 of this title] may be cited as the ‘Women’s
Health Research and Prevention Amendments of 1998’.’’

§ 201

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 105–277, div. A, § 101(f) [title IX, § 901], Oct. 21,
1998, 112 Stat. 2681–337, 2681–436, provided that: ‘‘This
title [enacting sections 300gg–6 and 300gg–52 of this title
and section 1185b of Title 29, Labor, and provisions set
out as notes under sections 300gg–6 and 300gg–52 of this
title and section 1185b of Title 29] may be cited as the
‘Women’s Health and Cancer Rights Act of 1998’.’’
Pub. L. 105–248, § 1, Oct. 9, 1998, 112 Stat. 1864, provided
that: ‘‘This Act [amending section 263b of this title]
may be cited as the ‘Mammography Quality Standards
Reauthorization Act of 1998’.’’
Pub. L. 105–196, § 1, July 16, 1998, 112 Stat. 631, provided that: ‘‘This Act [enacting sections 274l and 274m
of this title, amending sections 274g and 274k of this
title, repealing former section 274l of this title, and enacting provisions set out as notes under section 274k of
this title] may be cited as the ‘National Bone Marrow
Registry Reauthorization Act of 1998’.’’
Pub. L. 105–168, § 1(a), Apr. 21, 1998, 112 Stat. 43, provided that: ‘‘This Act [amending section 247b–4 of this
title and enacting provisions set out as a note under
section 247b–4 of this title] may be cited as the ‘Birth
Defects Prevention Act of 1998’.’’
SHORT TITLE OF 1997 AMENDMENT
Pub. L. 105–78, title VI, § 603(a), Nov. 13, 1997, 111 Stat.
1519, provided that: ‘‘This section [enacting section 284f
of this title and provisions set out as a note under section 284f of this title] may be cited as the ‘Morris K.
Udall Parkinson’s Disease Research Act of 1997’.’’
SHORT TITLE OF 1996 AMENDMENTS
Pub. L. 104–299, § 1, Oct. 11, 1996, 110 Stat. 3626, provided that: ‘‘This Act [enacting sections 254b and 254c
of this title, amending sections 233, 256c, 1395x, and
1396d of this title, repealing sections 256 and 256a of this
title, and enacting provisions set out as notes under
sections 233 and 254b of this title] may be cited as the
‘Health Centers Consolidation Act of 1996’.’’
Pub. L. 104–204, title VI, § 601, Sept. 26, 1996, 110 Stat.
2935, provided that: ‘‘This title [enacting sections
300gg–4 and 300gg–51 of this title and section 1185 of
Title 29, Labor, amending sections 300gg–21, 300gg–23,
300gg–44, 300gg–61, and 300gg–62 of this title and sections
1003, 1021, 1022, 1024, 1132, 1136, 1144, 1181, 1191, and 1191a
of Title 29, and enacting provisions set out as notes
under section 300gg–4 and 300gg–44 of this title and section 1003 of Title 29] may be cited as the ‘Newborns’ and
Mothers’ Health Protection Act of 1996’.’’
Pub. L. 104–204, title VII, § 701, Sept. 26, 1996, 110 Stat.
2944, provided that: ‘‘This title [enacting section
300gg–5 of this title and section 1185a of Title 29, Labor,
and enacting provisions set out as notes under section
300gg–5 of this title and section 1185a of Title 29] may
be cited as the ‘Mental Health Parity Act of 1996’.’’
Pub. L. 104–191, § 1(a), Aug. 21, 1996, 110 Stat. 1936, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘Health Insurance Portability and
Accountability Act of 1996’.’’
Pub. L. 104–182, § 1(a), Aug. 6, 1996, 110 Stat. 1613, provided that: ‘‘This Act [enacting sections 300g–7 to
300g–9, 300h–8, 300j–3c, and 300j–12 to 300j–18 of this title
and section 1263a of Title 33, Navigation and Navigable
Waters, amending sections 300f, 300g–1 to 300g–6, 300h,
300h–5 to 300h–7, 300i, 300i–1, 300j to 300j–2, 300j–4 to
300j–8, 300j–11, and 300j–21 to 300j–25 of this title, sections 4701 and 4721 of Title 16, Conservation, and section
349 of Title 21, Food and Drugs, repealing section 13551
of this title, enacting provisions set out as notes under
this section, sections 300f, 300g–1, 300j–1, and 300j–12 of
this title, section 1281 of Title 33, and section 45 of
former Title 40, Public Buildings, Property, and Works,
and amending provisions set out as a note under this
section] may be cited as the ‘Safe Drinking Water Act
Amendments of 1996’.’’
Pub. L. 104–146, § 1, May 20, 1996, 110 Stat. 1346, provided that: ‘‘This Act [enacting sections 300ff–27a,
300ff–31, 300ff–33 to 300ff–37, 300ff–77, 300ff–78, 300ff–101,
and 300ff–111 of this title, amending sections 294n, 300d,

Page 38

300ff–11 to 300ff–17, 300ff–21 to 300ff–23, 300ff–26 to
300ff–29, 300ff–47 to 300ff–49, 300ff–51, 300ff–52, 300ff–54,
300ff–55, 300ff–64, 300ff–71, 300ff–74, 300ff–76, and 300ff–84
of this title, transferring section 294n of this title to
section 300ff–111 of this title, repealing sections 300ff–18
and 300ff–30 of this title, and enacting provisions set
out as notes under sections 300cc, 300ff–11, and 300ff–33
of this title and section 4103 of Title 5, Government Organization and Employees] may be cited as the ‘Ryan
White CARE Act Amendments of 1996’.’’
SHORT TITLE OF 1995 AMENDMENT
Pub. L. 104–73, § 1(a), Dec. 26, 1995, 109 Stat. 777, provided that: ‘‘This Act [amending section 233 of this title
and enacting provisions set out as a note under section
233 of this title] may be cited as the ‘Federally Supported Health Centers Assistance Act of 1995’.’’
SHORT TITLE OF 1993 AMENDMENTS
Pub. L. 103–183, § 1(a), Dec. 14, 1993, 107 Stat. 2226, provided that: ‘‘This Act [enacting sections 247b–6, 247b–7,
256d, 280b–1a, 285f–2, 300n–4a, and 300u–8 of this title,
amending sections 233, 238j, 242b, 242k, 242l, 242m, 247b,
247b–1, 247b–5, 247c, 247c–1, 254j, 280b, 280b–1, 280b–2,
280b–3, 280e–4, 300d, 300d–2, 300d–3, 300d–12, 300d–13,
300d–16, 300d–22, 300d–31, 300d–32, 300k, 300m, 300n, 300n–1,
300n–4, 300n–5, 300u–5, 300w, and 300aa–26 of this title, repealing sections 300d–1 and 300d–33 of this title, and enacting provisions set out as notes under sections 238j,
263b, 285f–2, and 300m of this title] may be cited as the
‘Preventive Health Amendments of 1993’.’’
Section 1(a) of Pub. L. 103–43 provided that: ‘‘This Act
[see Tables for classification] may be cited as the ‘National Institutes of Health Revitalization Act of 1993’.’’
SHORT TITLE OF 1992 AMENDMENTS
Pub. L. 102–539, § 1, Oct. 27, 1992, 106 Stat. 3547, provided that: ‘‘This Act [enacting section 263b of this
title and provisions set out as a note under section 263b
of this title] may be cited as the ‘Mammography Quality Standards Act of 1992’.’’
Pub. L. 102–531, § 1(a), Oct. 27, 1992, 106 Stat. 3469, provided that: ‘‘This Act [enacting sections 247b–3 to
247b–5, 247c–1, 256c, 280d–11, 300l–1, and 300u–7 of this
title, amending sections 236, 242l, 247b–1, 247d, 254b, 254c,
256, 256a, 280b to 280b–2, 285c–4, 285d–7, 285m–4, 289c,
290aa–9, 290bb–1, 292y, 293j, 293l, 294n, 295j, 295l, 295n,
295o, 296k, 298b–7, 300u, 300u–1, 300u–5, 300w, 300w–3 to
300w–5, 300aa–2, 300aa–15, 300aa–19, 300aa–26, 300cc,
300cc–2, 300cc–15, 300cc–17, 300cc–20, 300cc–31, 300ee–1,
300ee–2, 300ee–31, 300ee–32, 300ee–34, 300ff–11 to 300ff–13,
300ff–17, 300ff–27, 300ff–28, 300ff–41, 300ff–43, 300ff–49,
300ff–75, 4841, and 9604 of this title, section 1341 of Title
15, Trade and Commerce, and section 2001 of Title 25,
Indians, repealing section 297j of this title, enacting
provisions set out as notes under sections 236, 292y,
300e, and 300w–4 of this title, amending provisions set
out as notes under sections 241, 281, and 295k of this
title and section 303 of Title 38, Veterans’ Benefits, and
repealing provisions set out as notes under section 246
and 300e of this title] may be cited as the ‘Preventive
Health Amendments of 1992’.’’
Pub. L. 102–515, § 1, Oct. 24, 1992, 106 Stat. 3372, provided that: ‘‘This Act [enacting sections 280e to 280e–4
of this title and provisions set out as a note under section 280e of this title] may be cited as the ‘Cancer Registries Amendment Act’.’’
Pub. L. 102–501, § 1, Oct. 24, 1992, 106 Stat. 3268, provided that: ‘‘This Act [amending section 233 of this title
and enacting provisions set out as notes under section
233 of this title] may be cited as the ‘Federally Supported Health Centers Assistance Act of 1992’.’’
Pub. L. 102–493, § 1, Oct. 24, 1992, 106 Stat. 3146, provided that: ‘‘This Act [enacting sections 263a–1 to 263a–7
of this title and provisions set out as a note under section 263a–1 of this title] may be cited as the ‘Fertility
Clinic Success Rate and Certification Act of 1992’.’’
Pub. L. 102–410, § 1(a), Oct. 13, 1992, 106 Stat. 2094, provided that: ‘‘This Act [amending sections 299 to 299a–2,

Page 39

TITLE 42—THE PUBLIC HEALTH AND WELFARE

299b to 299b–3, 299c to 299c–3, 299c–5, and 300w–9 of this
title and enacting provisions set out as notes under sections 299a–2, 299b–1, and 299b–2 of this title] may be
cited as the ‘Agency for Health Care Policy and Research Reauthorization Act of 1992’.’’
Pub. L. 102–409, § 1, Oct. 13, 1992, 106 Stat. 2092, provided that: ‘‘This Act [enacting section 283a of this
title] may be cited as the ‘DES Education and Research
Amendments of 1992’.’’
Pub. L. 102–408, § 1(a), Oct. 13, 1992, 106 Stat. 1992, provided that: ‘‘This Act [enacting subchapter V of this
chapter and sections 297n, 298b–7, and 300d–51 of this
title, amending sections 242a, 296k to 296m, 296r, 297,
297–1, 297b, 297d, 297e, 298, 298b, and 298b–6 of this title
and section 1078–3 of Title 20, Education, repealing sections 295g–10a, 297c–1, and 297n of this title, enacting
provisions set out as notes under this section, sections
292, 295j, 295k, 296k, and 297b of this title, section 1078–3
of Title 20, and section 343–1 of Title 21, Food and
Drugs, and amending provisions set out as a note under
section 300x of this title] may be cited as the ‘Health
Professions Education Extension Amendments of
1992’.’’
Pub. L. 102–408, title II, § 201, Oct. 13, 1992, 106 Stat.
2069, provided that: ‘‘This title [enacting sections 297n
and 298b–7 of this title, amending sections 296k to 296m,
296r, 297, 297–1, 297b, 297d, 297e, 298, 298b, and 298b–6 of
this title, repealing sections 297c–1 and 297n of this
title, and enacting provisions set out as notes under
sections 296k and 297b of this title] may be referred to
as the Nurse Education and Practice Improvement
Amendments of 1992.’’
Pub. L. 102–352, § 1, Aug. 26, 1992, 106 Stat. 938, provided that: ‘‘This Act [amending sections 285n, 285n–2,
285o, 285o–2, 285p, 290aa–1, 290aa–3, 290cc–21, 290cc–28,
290cc–30, 300x–7, 300x–27, 300x–33, 300x–53, and 300y of this
title, enacting provisions set out as a note under section 285n of this title, and amending provisions set out
as notes under sections 290aa and 300x of this title] may
be cited as the ‘Public Health Service Act Technical
Amendments Act’.’’
Pub. L. 102–321, § 1(a), July 10, 1992, 106 Stat. 323, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘ADAMHA Reorganization Act’.’’
SHORT TITLE OF 1991 AMENDMENTS
Pub. L. 102–168, § 1, Nov. 26, 1991, 105 Stat. 1102, provided that: ‘‘This Act [amending sections 300u, 300u–5,
300aa–11, 300aa–12, 300aa–15, 300aa–16, 300aa–19, and
300aa–21 of this title, enacting provisions set out as a
note under section 300aa–11 of this title, and amending
provisions set out as a note under section 300aa–1 of
this title] may be cited as the ‘Health Information,
Health Promotion, and Vaccine Injury Compensation
Amendments of 1991’.’’
Pub. L. 102–96, § 1, Aug. 14, 1991, 105 Stat. 481, provided
that: ‘‘This Act [amending section 300cc–13 of this title
and enacting provisions set out as a note under section
300cc–13 of this title] may be cited as the ‘Terry Beirn
Community Based AIDS Research Initiative Act of
1991’.’’
SHORT TITLE OF 1990 AMENDMENTS
Pub. L. 101–639, § 1, Nov. 28, 1990, 104 Stat. 4600, provided that: ‘‘This Act [amending sections 290cc–13, 299a,
300x–3, and 300x–10 to 300x–12 of this title] may be cited
as the ‘Mental Health Amendments of 1990’.’’
Pub. L. 101–616, § 1, Nov. 16, 1990, 104 Stat. 3279, provided that: ‘‘This Act [enacting sections 274f, 274g, 274k,
and 274l of this title, amending sections 273 to 274d of
this title, enacting provisions set out as notes under
sections 273, 274, and 274k of this title, and repealing
provisions set out as a note under section 273 of this
title] may be cited as the ‘Transplant Amendments Act
of 1990’.’’
Pub. L. 101–613, § 1, Nov. 16, 1990, 104 Stat. 3224, provided that: ‘‘This Act [enacting sections 285g–4 and 290b
of this title and provisions set out as a note under section 285g–4 of this title] may be cited as the ‘National
Institutes of Health Amendments of 1990’.’’

§ 201

Pub. L. 101–597, § 1, Nov. 16, 1990, 104 Stat. 3013, provided that: ‘‘This Act [enacting sections 254f–1, 254o–1,
and 254r of this title, amending sections 242a, 254d to
254i, 254k, 254l to 254q–1, 254s, 294h, 294n, 294aa, 295g–1,
296m, 1320c–5, 1395l, 1395u, 1395x, 3505d, and 9840 of this
title and section 2123 of Title 10, Armed Forces, and enacting provisions set out as notes under sections 242a,
254l–1, and 254o of this title] may be cited as the ‘National Health Service Corps Revitalization Amendments of 1990’.’’
Pub. L. 101–590, § 1, Nov. 16, 1990, 104 Stat. 2915, provided that: ‘‘This Act [enacting subchapter X of this
chapter, amending sections 300w–4 and 300w–9 of this
title, and enacting provisions set out as a note under
section 300d of this title] may be cited as the ‘Trauma
Care Systems Planning and Development Act of 1990’.’’
Pub. L. 101–558, § 1, Nov. 15, 1990, 104 Stat. 2772, provided that: ‘‘This Act [amending sections 280b to 280b–3
of this title] may be cited as the ‘Injury Control Act of
1990’.’’
Pub. L. 101–557, § 1, Nov. 15, 1990, 104 Stat. 2766, provided that: ‘‘This Act [enacting sections 242q to 242q–5
of this title, amending sections 280c, 280c–2, 280c–3,
280c–5, 285e–2, 285e–3, 300u–6, 300ff–17, 300ff–51, and
300ff–52 of this title and section 4512 of Title 20, Education, and enacting provisions set out as a note under
section 300u–6 of this title] may be cited as the ‘Home
Health Care and Alzheimer’s Disease Amendments of
1990’.’’
Pub. L. 101–527, § 1(a), Nov. 6, 1990, 104 Stat. 2311, provided that: ‘‘This Act [enacting sections 254c–1, 254t,
256a, 294bb, 294cc, and 300u–6 of this title, amending sections 242k, 242m, 254b, 254c, 294m, 294o, and 295g–2 of this
title, enacting provisions set out as notes under sections 242k and 300u–6 of this title, and repealing provisions set out as a note under section 292h of this title]
may be cited as the ‘Disadvantaged Minority Health
Improvement Act of 1990’.’’
Pub. L. 101–502, § 1, Nov. 3, 1990, 104 Stat. 1285, provided that: ‘‘This Act [amending sections 207, 247b,
300aa–6, 300aa–11 to 300aa–13, 300aa–15, 300aa–16,
300aa–21, 300ff–13, 300ff–47, and 300ff–49 of this title, section 331 of Title 21, Food and Drugs, and section 201 of
Title 37, Pay and Allowances of the Uniformed Services, enacting provisions set out as notes under sections 300aa–2, 300aa–11, and 300aa–12 of this title and
section 201 of Title 37, and amending provisions set out
as a note under section 300aa–1 of this title] may be
cited as the ‘Vaccine and Immunization Amendments
of 1990’.’’
Pub. L. 101–381, § 1, Aug. 18, 1990, 104 Stat. 576, provided that: ‘‘This Act [enacting subchapter XXIV of
this chapter, transferring section 300ee–6 of this title to
section 300ff–48 of this title, amending sections 284a,
286, 287a, 287c–2, 289f, 290aa–3a, 299c–5, 300ff–48, and
300aaa to 300aaa–13 of this title, and enacting provisions set out as notes under sections 300x–4, 300ff–11,
300ff–46, and 300ff–80 of this title] may be cited as the
‘Ryan White Comprehensive AIDS Resources Emergency Act of 1990’.’’
Pub. L. 101–374, § 1, Aug. 15, 1990, 104 Stat. 456, provided that: ‘‘This Act [amending sections 290aa–12,
290cc–2, and 300x–4 of this title, enacting provisions set
out as notes under sections 289e, 290aa–12, 290cc–2, and
300x–4 of this title, and amending provisions set out as
a note under section 289e of this title] may be cited as
the ‘Drug Abuse Treatment Waiting Period Reduction
Amendments of 1990’.’’
Pub. L. 101–368, § 1, Aug. 15, 1990, 104 Stat. 446, provided that: ‘‘This Act [amending section 247b of this
title] may be cited as the ‘Tuberculosis Prevention
Amendments of 1990’.’’
Pub. L. 101–354, § 1, Aug. 10, 1990, 104 Stat. 409, provided that: ‘‘This Act [enacting subchapter XIII of this
chapter] may be cited as the ‘Breast and Cervical Cancer Mortality Prevention Act of 1990’.’’
SHORT TITLE OF 1989 AMENDMENT
Pub. L. 101–93, § 1, Aug. 16, 1989, 103 Stat. 603, provided
that: ‘‘This Act [see Tables for classification] may be

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

cited as the ‘Drug Abuse Treatment Technical Corrections Act of 1989’.’’
SHORT TITLE OF 1988 AMENDMENTS
Pub. L. 100–690, § 2011, Nov. 18, 1988, 102 Stat. 4193, provided that: ‘‘This subtitle [subtitle A (§§ 2011–2081) of
title II of Pub. L. 100–690, enacting sections 290aa–11 to
290aa–14, 290cc–11 to 290cc–13, 290ff, 300x–1a, 300x–4a,
300x–9a, and 300x–9b of this title, amending sections
242a, 290aa, 290aa–3, 290aa–6, 290aa–8, 290bb–2, 290cc to
290cc–2, 300x, 300x–1a to 300x–4, 300x–5, 300x–9, and
300x–10 to 300x–12 of this title and section 484 of former
Title 40, Public Buildings, Property, and Works, repealing sections 300y to 300y–2 of this title, enacting provisions set out as notes under this section and sections
290aa, 290cc–11, 300x–9a, and 300x–11 of this title, and
amending provisions set out as a note under section 801
of Title 21, Food and Drugs] may be cited as the ‘Comprehensive Alcohol Abuse, Drug Abuse, and Mental
Health Amendments Act of 1988’.’’
Pub. L. 100–607, § 1(a), Nov. 4, 1988, 102 Stat. 3048, provided that: ‘‘This Act [see Tables for classification]
may be cited as the ‘Health Omnibus Programs Extension of 1988’.’’
Pub. L. 100–607, title I, § 100(a), Nov. 4, 1988, 102 Stat.
3048, provided that: ‘‘This title [see Tables for classification] may be cited as the ‘National Institute on
Deafness and Other Communication Disorders and
Health Research Extension Act of 1988’.’’
Pub. L. 100–607, title II, § 200, Nov. 4, 1988, 102 Stat.
3062, provided that: ‘‘This title [see Tables for classification] may be cited as the ‘AIDS Amendments of
1988’.’’
Pub. L. 100–607, title IV, § 401(a), Nov. 4, 1988, 102 Stat.
3114, provided that: ‘‘This title [enacting sections
300y–21 to 300y–27 of this title, amending sections 273 to
274e of this title, and enacting provisions set out as
notes under sections 273 and 300y–21 of this title] may
be cited as the ‘Organ Transplant Amendments Act of
1988’.’’
Pub. L. 100–607, title VI, § 601(a), Nov. 4, 1988, 102 Stat.
3122, as amended by Pub. L. 100–690, title II, § 2603(a)(1),
Nov. 18, 1988, 102 Stat. 4234, provided that: ‘‘This title
[see Tables for classification] may be cited as the
‘Health Professions Reauthorization Act of 1988’.’’
Pub. L. 100–607, title VII, § 700(a), Nov. 4, 1988, 102
Stat. 3153, provided that: ‘‘This title [enacting sections
296r, 297c–1, 297j, 297n, and 298b–6 of this title, amending
sections 210, 294a, 296k, 296l, 296m, 297, 297–1, 297a, 297b,
297d, 297e, 298, and 298b–3 of this title, and enacting provisions set out as a note under section 297d of this title]
may be cited as the ‘Nursing Shortage Reduction and
Education Extension Act of 1988’.’’
Pub. L. 100–607, title IX, § 901, Nov. 4, 1988, 102 Stat.
3171, provided that: ‘‘This title [enacting section 300ee–6
of this title and provisions set out as notes under such
section] may be cited as the ‘Prison Testing Act of
1988’.’’
Pub. L. 100–578, § 1, Oct. 31, 1988, 102 Stat. 2903, provided that: ‘‘This Act [amending section 263a of this
title and enacting provisions set out as notes under section 263a of this title] may be cited as the ‘Clinical Laboratory Improvement Amendments of 1988’.’’
Pub. L. 100–572, § 1, Oct. 31, 1988, 102 Stat. 2884, provided that: ‘‘This Act [enacting sections 247b–1 and
300j–21 to 300j–26 of this title, and amending section
300j–4 of this title] may be cited as the ‘Lead Contamination Control Act of 1988’.’’
Pub. L. 100–553, § 1, Oct. 28, 1988, 102 Stat. 2769, provided that: ‘‘This Act [enacting sections 285m to 285m–6
of this title, amending sections 281 and 285j of this title,
and enacting provisions set out as a note under section
285m of this title] shall be cited as the ‘National Deafness and Other Communication Disorders Act of 1988’.’’
Pub. L. 100–517, § 1(a), Oct. 24, 1988, 102 Stat. 2578, provided that: ‘‘This Act [amending sections 300e, 300e–1,
300e–9, and 300e–10 of this title, enacting provisions set
out as notes under sections 300e, 300e–9, and 1302 of this
title, and repealing provisions set out as notes under
section 300e–1 of this title] may be cited as the ‘Health
Maintenance Organization Amendments of 1988’.’’

Page 40

Pub. L. 100–386, § 1(a), Aug. 10, 1988, 102 Stat. 919, provided that: ‘‘This Act [amending sections 254b and 254c
of this title and enacting provisions set out as a note
under section 254b of this title] may be cited as the
‘Community and Migrant Health Centers Amendments
of 1988’.’’
SHORT TITLE OF 1987 AMENDMENTS
Pub. L. 100–203, title IV, § 4301(a), Dec. 22, 1987, 101
Stat. 1330–221, provided that: ‘‘This subtitle [subtitle D
(§§ 4301–4307) of title IV of Pub. L. 100–203, enacting section 300aa–34 of this title, amending sections 300aa–11
to 300aa–13, 300aa–15 to 300aa–17, 300aa–19, 300aa–21 to
300aa–23, 300aa–25 to 300aa–28, and 300aa–31 of this title,
repealing section 300aa–18 of this title, and amending
provisions set out as a note under section 300aa–1 of
this title] may be cited as the ‘Vaccine Compensation
Amendments of 1987’.’’
Pub. L. 100–177, § 1(a), Dec. 1, 1987, 101 Stat. 986, provided that: ‘‘This Act [enacting sections 254l–1, 254q,
and 254q–1 of this title, amending sections 242a, 242c,
242k, 242m, 242n, 242p, 247b, 254d to 254g, 254h–1, 254k,
254m to 254q, 254r, 295g–8, and 11137 of this title, repealing former section 254q of this title, and enacting provisions set out as notes under sections 242c, 242k, 242m,
254l–1, 254o, 300aa–2, and 11137 of this title] may be cited
as the ‘Public Health Service Amendments of 1987’.’’
Pub. L. 100–175, title VI, § 601, Nov. 29, 1987, 101 Stat.
979, provided that: ‘‘This title [enacting part K (§ 280c et
seq.) of subchapter II of this chapter] may be cited as
the ‘Health Care Services in the Home Act of 1987’.’’
Pub. L. 100–97, § 1, Aug. 18, 1987, 101 Stat. 713, provided:
‘‘That this Act [enacting section 295g–8a of this title
and provisions set out as a note under section 295g–8a
of this title] may be cited as the ‘Excellence in Minority Health Education and Care Act’.’’
SHORT TITLE OF 1986 AMENDMENTS
Pub. L. 99–660, title III, § 301, Nov. 14, 1986, 100 Stat.
3755, provided that: ‘‘This title [enacting sections
300aa–1 to 300aa–33 of this title, amending sections 218,
242c, 262, 286, and 289f of this title, redesignating former
sections 300aa to 300aa–15 of this title as sections 300cc
to 300cc–15 of this title, and enacting provisions set out
as notes under sections 300aa–1 and 300aa–4 of this title]
may be cited as the ‘National Childhood Vaccine Injury
Act of 1986’.’’
Pub. L. 99–660, title V, § 501, Nov. 14, 1986, 100 Stat.
3794, provided that: ‘‘This title [enacting sections
300x–10 to 300x–13 of this title and amending sections
290aa–3 and 300x–4 of this title] may be cited as the
‘State Comprehensive Mental Health Services Plan Act
of 1986’.’’
Pub. L. 99–660, title VIII, § 801, Nov. 14, 1986, 100 Stat.
3799, provided that: ‘‘This title [amending sections
300e–1, 300e–4, 300e–5 to 300e–10, 300e–16, and 300e–17 of
this title, repealing sections 300e–2, 300e–3, and 300e–4a
of this title, and enacting provisions set out as notes
under sections 300e, 300e–1, 300e–4, and 300e–5 of this
title] may be cited as the ‘Health Maintenance Organization Amendments of 1986’.’’
Pub. L. 99–649, § 1, Nov. 10, 1986, 100 Stat. 3633, provided: ‘‘That this Act [enacting sections 280b to 280b–3
of this title and provisions set out as a note under section 280b of this title] may be cited as the ‘Injury Prevention Act of 1986’.’’
Pub. L. 99–570, title IV, § 4001(a), Oct. 27, 1986, 100 Stat.
3207–103, provided that: ‘‘This subtitle [subtitle A
(§§ 4001–4022) of title IV of Pub. L. 99–570, enacting sections 290aa–3a, 290aa–6 to 290aa–10, and 300y to 300y–2 of
this title, amending sections 218, 241, 290aa to 290aa–3,
290aa–4, 290aa–5, 290bb–1, 290bb–2, 290cc, and 290cc–2 of
this title and sections 331 and 350a of Title 21, Food and
Drugs, and enacting provisions set out as notes under
sections 290aa–3, 290aa–3a, and 290bb of this title] may
be cited as the ‘Alcohol and Drug Abuse Amendments
of 1986’.’’
Pub. L. 99–339, § 1, June 19, 1986, 100 Stat. 642, provided
that: ‘‘This Act [enacting sections 300g–6, 300h–5 to

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

300h–7, 300i–1, and 300j–11 of this title, amending sections 300f, 300g–1 to 300g–5, 300h to 300h–2, 300h–4, 300h–6,
300h–7, 300i, 300j to 300j–4, 300j–7, and 6979a of this title
and sections 1261 and 1263 of Title 15, Commerce and
Trade, transferring section 6939b to 6979a of this title,
and enacting provisions set out as notes under sections
300g–6 and 300j–1 of this title and section 1261 of Title
15] may be cited as the ‘Safe Drinking Water Act
Amendments of 1986’.’’
Pub. L. 99–280, § 1(a), Apr. 24, 1986, 100 Stat. 399, provided that: ‘‘This Act [amending sections 254b and 254c
of this title and repealing sections 300y to 300y–11 of
this title] may be cited as the ‘Health Services Amendments Act of 1986’.’’
SHORT TITLE OF 1985 AMENDMENTS
Pub. L. 99–158, § 1(a), Nov. 20, 1985, 99 Stat. 820, provided that: ‘‘This Act [enacting sections 275, 281 to 283,
284 to 284c, 285 to 285a–5, 285b to 285b–6, 285c to 285c–7,
285d to 285d–7, 285e to 285e–2, 285f, 285g to 285g–3, 285h,
285i, 285j to 285j–2, 285k, 285l, 286 to 286a–1, 286b to 286b–8,
287 to 287a–1, 287b, 287c to 287c–3, 288 to 288b, and 289 to
289h of this title, amending sections 217a, 218, 241,
290aa–5, and 300c–12 of this title, repealing sections 275
to 280a–1, 280b to 280b–2, 280b–4, 280b–5, and 280b–7 to
280b–11 of this title, omitting sections 286c to 286e, 287d
to 287i, 288c, 289, 289c–1 to 289c–3, 289c–4 to 289c–7, 289i to
289k, 289k–2 to 289k–5, and 289l to 289l–8 of this title, enacting provisions set out as notes under sections 218,
281, 285c, 285e, 285e–2, 285j–1 and 289d of this title, and
repealing provisions set out as a note under section 287i
of this title] may be cited as the ‘Health Research Extension Act of 1985’.’’
Pub. L. 99–129, § 1, Oct. 22, 1985, 99 Stat. 523, provided:
‘‘That this Act [enacting sections 294q–1 to 294q–3 of
this title, amending sections 254l, 292a, 292b, 292h, 292j,
293c, 294a, 294b, 294d, 294e, 294g, 294j, 294m to 294p, 294z,
295f to 295f–2, 295g, 295g–1, 295g–3, 295g–4, 295g–6 to
295g–8, 295g–8b, 295h, 295h–1a to 295h–1c, 296k, 296l, 296m,
297a, 298b–5, and 300aa–14 of this title, repealing sections 292c, 295 to 295e–5, 295g–2, 295g–5, 295g–8a, and
295g–9 of this title, enacting provisions set out as notes
under sections 254l, 292h, 293c, 294d, 294n, and 300aa–14 of
this title and section 462 of the Appendix to Title 50,
War and National Defense, and amending provisions set
out as a note under section 298b–5 of this title] may be
cited as the ‘Health Professions Training Assistance
Act of 1985’.’’
Pub. L. 99–117, § 1(a), Oct. 7, 1985, 99 Stat. 491, provided
that: ‘‘this Act [amending sections 207, 210, 213a, 242c,
242n, 243, 246, 247b, 247e, 253, 290aa–3, 300x–4, 300x–5, and
300x–9 of this title and section 1333 of Title 15, Commerce and Trade, repealing sections 247, 254a–1, 299 to
299j, 300d–4, 300d–6, and 300aa–4 of this title, and enacting provisions set out as notes under sections 210, 241,
and 242n of this title] may be cited as the ‘Health Services Amendments of 1985’.’’
Pub. L. 99–92, § 1, Aug. 16, 1985, 99 Stat. 393, provided:
‘‘That this Act [enacting section 297i of this title,
transferring section 296c to section 298b–5 of this title,
amending sections 296k to 296m, 297, 297–1, 297a, 297b,
297d, 297e, 298, 298b, and 298b–5 of this title, sections
1332, 1333, 1336, and 1341 of Title 15, Commerce and
Trade, and section 6103 of Title 26, Internal Revenue
Code, repealing sections 296 to 296b, 296d to 296f, 296j,
297h, and 297j of this title, and enacting provisions set
out as notes under sections 296k and 298b–5 of this title
and section 1333 of Title 15] may be cited as the ‘Nurse
Education Amendments of 1985’.’’
SHORT TITLE OF 1984 AMENDMENTS
Pub. L. 98–555, § 1(a), Oct. 30, 1984, 98 Stat. 2854, provided that: ‘‘this Act [enacting sections 300w–9 and
300w–10 of this title and amending sections 247b, 247c,
255, 300, 300w, 300w–4, and 300w–5 of this title] may be
cited as the ‘Preventive Health Amendments of 1984’.’’
Pub. L. 98–551, § 1, Oct. 30, 1984, 98 Stat. 2815, provided:
‘‘That this Act [enacting section 300u–5 of this title,
amending sections 242b, 242c, 242m, 242n, 254r, 300u, and

§ 201

300u–3 of this title and sections 360bb and 360ee of Title
21, Food and Drugs, and repealing sections 300u–5 to
300u–9 of this title] may be cited as the ‘Health Promotion and Disease Prevention Amendments of 1984’.’’
Pub. L. 98–509, § 1(a), Oct. 19, 1984, 98 Stat. 2353, provided that: ‘‘this Act [enacting sections 290bb–1a,
290cc–1, 290cc–2, and 300x–1a of this title, amending sections 218, 290aa, 290aa–1 to 290aa–3, 290bb, 290bb–2, 290cc,
290dd, 290dd–1, 300x, 300x–1, and 300x–2 to 300x–9 of this
title and section 802 of Title 21, Food and Drugs, repealing sections 1161 to 1165 of Title 21, and enacting provisions set out as notes under sections 300x and 300x–1a of
this title and section 802 of Title 21] may be cited as the
‘Alcohol Abuse, Drug Abuse, and Mental Health
Amendments of 1984’.’’
Pub. L. 98–507, § 1, Oct. 19, 1984, 98 Stat. 2339, provided:
‘‘That this Act [enacting sections 273 to 274e of this
title and provisions set out as notes under section 273
of this title] may be cited as the ‘National Organ
Transplant Act’.’’
SHORT TITLE OF 1983 AMENDMENTS
Pub. L. 98–194, § 1, Dec. 1, 1983, 97 Stat. 1345, provided:
‘‘That this Act [amending section 254g of this title and
enacting provisions set out as notes under section 254g
of this title] may be cited as the ‘Rural Health Clinics
Act of 1983’.’’
Pub. L. 98–24, § 1(a), Apr. 26, 1983, 97 Stat. 175, provided
that: ‘‘This Act [enacting sections 290aa–4 and 290aa–5
of this title, transferring sections 219 to 224, 225a to 227,
228 to 229d, 289k–1, 3511, 4551, 4585, 4587, 4588, 4571, 4561,
4581, and 4582 of this title to sections 300aa to 300aa–5,
300aa–6 to 300aa–8, 300aa–9 to 300aa–14, 290aa–3, 290aa,
290aa–1, 290bb, 290bb–1, 290bb–2, 290dd, 290dd–1, 290dd–2,
and 290dd–3 of this title, respectively, and sections
1173(a), 1174, 1175, 1180, 1191, 1192, and 1193 of Title 21,
Food and Drugs, to sections 290aa–2(e), 290ee–2, 290ee–3,
290ee–1, 290aa–2, 290ee, and 290cc of this title, respectively, amending sections 218, 278, 289l–4, 290aa to
290aa–2, 290bb to 290bb–2, 290cc, 290dd to 290dd–2, 290ee to
290ee–3, and 4577 of this title and sections 1165, 1173, and
1177 of Title 21, repealing sections 4552, 4553, and 4586 of
this title and sections 1117, 1172, and 1194 of Title 21, enacting provisions set out as a note under section 290aa
of this title, amending provisions set out as a note
under section 4541 of this title, and repealing provisions
set out as a note under section 242 of this title] may be
cited as the ‘Alcohol and Drug Abuse Amendments of
1983’.’’
SHORT TITLE OF 1981 AMENDMENT
Section 940(a) of Pub. L. 97–35 provided that: ‘‘This
subtitle [subtitle F (§§ 940–949) of title IX of Pub. L.
97–35, amending sections 300e to 300e–4a, 300e–6 to
300e–9, 300e–11, 300e–17, and 300m–6 of this title, repealing sections 300e–13 and 300e–15 of this title, and enacting provisions set out as notes under sections 300e–9
and 300m–6 of this title] may be cited as the ‘Health
Maintenance Organization Amendments of 1981’.’’
SHORT TITLE OF 1980 AMENDMENT
Pub. L. 96–538, § 1(a), Dec. 17, 1980, 94 Stat. 3183, provided that: ‘‘this Act [enacting sections 289c–3, 289c–4,
289c–7 of this title, amending sections 286e, 287c, 287i,
289a, 289c–1, 289c–2, 289c–5, 289c–6, 294a, 294d, 294v, 300k–1,
300l–5, 300m, 300m–3, 300m–6, 300n, and 300n–1 of this
title and section 1182 of Title 8, Aliens and Nationality,
repealing sections 289c–3a and 289c–8 and former sections 289c–3, 289c–4, and 289c–7 of this title, and enacting provisions set out as notes under sections 289,
300l–5, and 300m–6 of this title] may be cited as the
‘Health Programs Extension Act of 1980’.’’
SHORT TITLE OF 1979 AMENDMENTS
Pub. L. 96–142, title I, § 101, Dec. 12, 1979, 93 Stat. 1067,
provided that: ‘‘This title [amending sections 295g–9,
300d–1, 300d–3, 300d–5, 300d–6, 300d–8, and 300d–21 of this
title and enacting provisions set out as a note under
section 295g–9 of this title] may be cited as the ‘Emergency Medical Services Systems Amendments of 1979’.’’

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Pub. L. 96–142, title II, § 201, Dec. 12, 1979, 93 Stat. 1070,
provided that: ‘‘This title [enacting section 300c–12 and
amending section 300c–11 of this title] may be cited as
the ‘Sudden Infant Death Syndrome Amendments of
1979’.’’
Section 1(a) of Pub. L. 96–79 provided that: ‘‘This Act
[enacting sections 300m–6, 300s, 300s–1, 300s–6, and
300t–11 to 300t–14 of this title, amending this section
and sections 246, 300k–1 to 300k–3, 300l to 300l–5, 300m to
300m–5, 300n, 300n–1, 300n–3, 300n–5, 300q, 300q–2, 300r,
300s–3, 300s–5, 300t, 1396b, 2689t, and 4573 of this title and
section 1176 of Title 21, Food and Drugs, repealing sections 300o to 300o–3, 300p to 300p–3, 300q–1, and former
section 300s of this title, redesignating former section
300s–1 as 300s–1a of this title, and enacting provisions
set out as notes under sections 300k–1, 300l, 300l–1,
300l–4, 300l–5, 300m, 300m–6, 300n, 300q, and 300t–11 of this
title] may be cited as the ‘Health Planning and Resources Development Amendments of 1979’.’’
Pub. L. 96–76, title I, § 101(a), Sept. 29, 1979, 93 Stat.
579, provided that: ‘‘This title [enacting section 297–1 of
this title, amending sections 296, 296d, 296e, 296k to
296m, 297 to 297c, 297e, and 297j of this title, and enacting provisions set out as notes under sections 296 and
297j of this title] may be cited as the ‘Nurse Training
Amendments of 1979’.’’
Pub. L. 96–76, title III, § 301, Sept. 29, 1979, 93 Stat. 584,
provided that: ‘‘This title [amending sections 204, 206,
207, 209, 210–1, 210b, 211, 212, 213a, 215, and 218a of this
title and sections 201, 415, and 1006 of Title 37, Pay and
Allowances of the Uniformed Services, and enacting
provisions set out as a note under section 206 of this
title] may be cited as the ‘Public Health Service Administrative Amendments of 1979’.’’
SHORT TITLE OF 1978 AMENDMENTS
Pub. L. 95–626, § 1(a), Nov. 10, 1978, 92 Stat. 3551, provided that: ‘‘This Act [enacting sections 242p, 247, 247a,
247b–1, 254a–1, 255, 256, 256a, 300a–21 to 300a–29, 300a–41,
300b–6, and 300u–6 to 300u–9 of this title, amending sections 218, 246, 247b, 247c, 247e, 254a, 254b, 254c, 254k, 294t,
294u, 295h–1, 300b, 300b–3, 300c–21, 300c–22, 300d–2, 300d–3,
300d–5, 300d–6, 300e–12, 300e–14a, 300u–5, 1396b, and 4846 of
this title, repealing sections 256, 4801, 4811, 4844, and
4845 of this title, enacting provisions set out as notes
under this section and sections 246, 247a, 247c, 254a–1,
254b to 254d, 256, 256a, 289b, 289d, 300a–21, 300d–2, and
300d–3 of this title, and amending provisions set out as
notes under sections 300b and 1395x of this title] may be
cited as the ‘Health Services and Centers Amendments
of 1978’.’’
Pub. L. 95–626, title I, § 101, Nov. 10, 1978, 92 Stat. 3551,
provided that: ‘‘This part [part A (§§ 101–107) of title I of
Pub. L. 95–626, enacting section 256a of this title,
amending sections 218, 247e, 254b, 254c, 255, 300e–12,
300e–14a, and 1396b of this title, repealing section 256 of
this title, and enacting provisions set out as notes
under sections 254b, 254c, and 256a of this title] may be
cited as the ‘Migrant and Community Health Centers
Amendments of 1978’.’’
Pub. L. 95–626, title I, § 111, Nov. 10, 1978, 92 Stat. 3562,
provided that: ‘‘This part [part B (§§ 111–116) of title I of
Pub. L. 95–626, enacting sections 254a–1 and 256 of this
title, amending sections 294t and 294u of this title, and
enacting provisions set out as notes under sections
254a–1, 254d, and 256 of this title] may be cited as the
‘Primary Health Care Act of 1978’.’’
Pub. L. 95–626, title II, § 200, Nov. 10, 1978, 92 Stat. 3570,
provided that: ‘‘This title [enacting sections 247, 247a,
255, and 300b–6 of this title, amending sections 246, 247b,
247c, 300b, 300b–3, 300c–21, 300c–22, 300d–2, 300d–3, 300d–5,
300d–6, and 4846 of this title, repealing sections 4801,
4811, 4844, and 4845 of this title, enacting provisions set
out as notes under sections 246, 247a, 247c, 289d, 300d–2,
and 300d–3 of this title, and amending provisions set out
as notes under sections 300b and 1395x of this title] may
be cited as the ‘Health Services Extension Act of 1978’.’’
Pub. L. 95–623, § 1(a), Nov. 9, 1978, 92 Stat. 3443, provided that: ‘‘This Act [enacting sections 229c, 242n, and
4362a of this title, amending sections 210, 242b, 242c,

Page 42

242k, 242m, 242o, 289k, 289l–1, 292e, 292h, 292i, 294t, 295f–1,
295f–2, 295g–2, 295g–8, 295h–2, 7411, 7412, 7417, and 7617 of
this title, repealing section 280c of this title, enacting
provisions set out as a note under section 242m of this
title, and amending provisions set out as notes under
sections 292h, 295h–4, and 296 of this title] may be cited
as the ‘Health Services Research, Health Statistics,
and Health Care Technology Act of 1978’.’’
Pub. L. 95–622, title II, § 201(a), Nov. 9, 1978, 92 Stat.
3420, provided that: ‘‘This title [enacting sections 289l–6
to 289l–8 of this title, amending sections, 241, 248, 277,
280b, 281 to 286g, 287a to 287d, 287g, 287i, 289c–6, 289l to
289l–2, 289l–4, 4541, 4573, and 4585 of this title, and enacting provisions set out as notes under sections 241, 286b,
286f, 289a, and 289l–1 of this title] may be cited as the
‘Biomedical Research and Research Training Amendments of 1978’.’’
Pub. L. 95–559, § 1(a), Nov. 1, 1978, 92 Stat. 2131, provided that: ‘‘This Act [enacting sections 300e–4a,
300e–16, and 300e–17 of this title, amending sections
300e, 300e–1, 300e–3, 300e–4, 300e–5, 300e–7, 300e–8, 300e–9,
300e–11 to 300e–13, 1320a–1, 1396a, and 1396b of this title,
and enacting provisions set out as notes under sections
300e–3, 300e–4, 300e–16, and 1396a of this title] may be
cited as the ‘Health Maintenance Organization Amendments of 1978’.’’
SHORT TITLE OF 1977 AMENDMENTS
Pub. L. 95–190, § 1, Nov. 16, 1977, 91 Stat. 1393, provided
that: ‘‘This Act [enacting sections 300j–10 and 7625a of
this title, amending sections 300f, 300g–1, 300g–3, 300g–5,
300h, 300h–1, 300j to 300j–2, 300j–4, 300j–6, 300j–8, 7410, 7411,
7413, 7414, 7416, 7419, 7420, 7426, 7472 to 7475, 7478, 7479,
7502, 7503, 7506, 7521, 7522, 7525, 7541, 7545, 7549, 7602, 7604,
7607, 7623, and 7626 of this title, enacting provisions set
out as notes under section 300f of this title, and section
5108 of Title 5, Government Organization and Employees, and amending provisions set out as notes under
sections 300f, 7401, and 7502 of this title] may be cited
as the ‘Safe Drinking Water Amendments of 1977’.’’
Section 101 of title I of Pub. L. 95–83 provided that:
‘‘This title [amending this section and sections 242m,
300e–8, 300k–3, 300l to 300l–5, 300m, 300m–2, 300m–4,
300m–5, 300n–3, 300n–5, 300o–1 to 300o–3, 300p, 300p–3, 300q,
300q–2, 300r, 300s–3, 300t, and 1396b of this title, and enacting provisions set out as a note under section 1396b
of this title] may be cited as the ‘Health Planning and
Health Services Research and Statistics Extension Act
of 1977’.’’
Section 201 of title II of Pub. L. 95–83 provided that:
‘‘This title [amending sections 280b, 286b, 286c, 286d,
286f, 286g, 287c, 287d, 287f, 287h, 287i, and 289l–1 of this
title] may be cited as the ‘Biomedical Research Extension Act of 1977’.’’
Section 301 of title III of Pub. L. 95–83 provided that:
‘‘This title [enacting section 294y–1 of this title, amending sections 210, 246, 247d, 254c, 292g, 292h, 293a, 294d,
294e, 294h, 294i, 294j, 294n, 294r, 294s, 294w, 294z, 295f–1,
295g–1, 295g–9, 295h–5, 295h–5c, 296e, 296m, 297, 300, 300a–1,
300a–2, 300a–3, 300c–11, 300c–21, 300c–22, 701, 2689a to
2689e, 2689h, 2689p, 2689q, 4572, 4573, and 4577 of this title,
sections 1101 and 1182 of Title 8, Aliens and Nationality,
sections 1112 and 1176 of Title 21, Food and Drugs, and
section 1614 of Title 25, Indians, enacting provisions set
out as notes under sections 242b, 242l, 294d, 294i, 294n,
294r, 294t, 294y–1, 294z, 295f–1, 295g–1, 295h–5, and 296m of
this title and sections 1101 and 1182 of Title 8, and
amending provisions set out as notes under sections
289k–2, 1395x, and 1396b of this title] may be cited as the
‘Health Services Extension Act of 1977’.’’
SHORT TITLE OF 1976 AMENDMENTS
Pub. L. 94–573, § 1(a), Oct. 21, 1976, 90 Stat. 2709, provided that: ‘‘This Act [enacting section 300d–21 of this
title, amending sections 295f–6 and 300d to 300d–9 of this
title, enacting provisions set out as notes under sections 242b, 300d, 300d–7, and 300d–9 of this title, and
amending provisions set out as notes under sections
218, 289c–1, and 289l–1 of this title] may be cited as the
‘Emergency Medical Services Amendments of 1976’.’’

Page 43

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 94–562, § 1(a), Oct. 19, 1976, 90 Stat. 2645, provided that: ‘‘This Act [enacting sections 289c–3a, 289c–7,
and 289c–8 of this title, amending sections 289c–2,
289c–5, and 289c–6 of this title, and enacting provisions
set out as notes under sections 289a, 289c–3a, and 289c–7
of this title] may be cited as the ‘Arthritis, Diabetes,
and Digestive Disease Amendments of 1976’.’’
Section 1(a) of Pub. L. 94–484 provided that: ‘‘This Act
[enacting sections 254 to 254k, 292, 292e to 292k, 294 to
294l, 294r to 294z, 294aa, 295f–1, 295g to 295g–8, 295g–10,
295h to 295h–2, and 295h–4 to 295h–7 of this title; renumbering sections 293d as 292a, 293e as 292b, 295h–8 as 292c,
295h–9 as 292d, 293g to 293i as 293d to 293f, 294 to 294c as
294m to 294p, 294e as 294q, 295f–5 as 295f–2, and 295f–6 as
295g–9 of this title; amending this section and sections
234, 244–1, 245a, 246, 247c, 254b, 263c, 292a to 292c, 293 to
293d, 293f, 294g, 294m to 294p, 295e–1 to 295e–4, 295f to
295f–4, 295g, 295g–11, 295g–23, 295h–1 to 295h–3, 297, 300a,
300d, 300d–7, 300f, 300l–1, 300n, and 300s–3 of this title and
sections 1101 and 1182 of Title 8, Aliens and Nationality;
repealing sections 234, 244–1, 245a, 254b, 292 to 292j, 293f,
294d, 294f, 294g, 295f–1, to 295f–4, 295g, 295g–1, 295g–11, and
295g–21 to 295g–23 of this title; omitting sections 295h to
295h–2, 295h–3a to 295h–3d, 295h–4, 295h–5, and 295h–7 of
this title; and enacting provisions set out as notes
under sections 254d, 292, 292b, 292h, 293, 293f, 294, 294n,
294o, 294q, 294r, 294t, 294z, 295g, 295g–1, 295g–9, 295g–10,
295h, 295h–4, and 300l–1 of this title and section 1182 of
Title 8] may be cited as the ‘Health Professions Educational Assistance Act of 1976’.’’
Pub. L. 94–460, § 1(a), Oct. 8, 1976, 90 Stat. 1945, provided that: ‘‘This Act [enacting section 300e–15 of this
title, amending sections 242c, 289k–2, 300e, 300e–1 to
300e–11, 300e–13, 300n–1, 1395x note, 1395mm, and 1396b of
this title, section 8902 of Title 5, Government Organization and Employees, and section 360d of Title 21, Food
and Drugs, and enacting provisions set out as notes
under sections 300e and 1396b of this title] may be cited
as the ‘Health Maintenance Organization Amendments
of 1976’.’’
Pub. L. 94–380, § 1, Aug. 12, 1976, 90 Stat. 1113, provided:
‘‘That this Act [amending section 247b of this title and
enacting provisions set out as a note under section 247b
of this title] may be cited as the ‘National Swine Flu
Immunization Program of 1976’.’’
Section 101 of title I of Pub. L. 94–317 provided that:
‘‘This title [enacting subchapter XV of this chapter]
may be cited as the ‘National Consumer Health Information and Health Promotion Act of 1976’.’’
Section 201 of title II of Pub. L. 94–317 provided that:
‘‘This title [amending sections 243, 247b, 247c, 4801, 4831,
and 4841 to 4843 of this title and enacting provisions set
out as notes under sections 247b and 247c of this title]
may be cited as the ‘Disease Control Amendments of
1976’.’’
Pub. L. 94–278, § 1(a), Apr. 22, 1976, 90 Stat. 401, provided that: ‘‘This Act [enacting sections 217a–1, 289l–5,
300b, 300b–1 to 300b–5 of this title and sections 350 and
378 of Title 21, Food and Drugs, and amending sections
213e, 225a, 234, 241, 247d, 254c, 287, 287a to 287d, 287f to
287i, 289a, 289c–1, 289c–5, 289c–6, 289l–1, 289l–2, 294b,
295g–23, 300c–11, 300l, 300p–3, 300s–1, 6062 and 6064 of this
title and sections 321, 333, 334 and 343 of Title 21, and enacting provisions set out as notes under sections 218,
287, 289c–1, 289c–2, 289l–1, 300b and 6001 of this title and
sections 334 and 350 of Title 21] may be cited as the
‘Health Research and Health Services Amendment of
1976’.’’
Pub. L. 94–278, title IV, § 401, Apr. 22, 1976, 90 Stat. 407,
provided that: ‘‘This title [enacting part A of subchapter IX of this chapter, omitting former Part B of
of subchapter IX of this chapter relating to Cooley’s
Anemia Programs, redesignating former Parts C and D
of subchapter IX of this chapter as Parts B and C of
subchapter IX of this chapter, respectively, and amending section 300c–11 of this title] may be cited as the
‘National Sickle Cell Anemia, Cooley’s Anemia, TaySachs, and Genetic Diseases Act’.’’
Pub. L. 94–278, title VI, § 601, Apr. 22, 1976, 90 Stat. 413,
provided that: ‘‘This title [amending sections 289a,

§ 201

289c–1, 289c–5, and 289c–6 of this title and amending provisions set out as notes under section 289c–1 of this
title] may be cited as the ‘National Arthritis Act Technical Amendments of 1976’.’’
SHORT TITLE OF 1975 AMENDMENTS
Pub. L. 94–63, title I, § 101, July 29, 1975, 89 Stat. 304,
provided that: ‘‘This title [amending section 246 of this
title and enacting provisions set out as a note under
section 246 of this title] may be cited as the ‘Special
Health Revenue Sharing Act of 1975’.’’
Pub. L. 94–63, title II, § 201, July 29, 1975, 89 Stat. 306,
provided that: ‘‘This title [enacting sections 300a–6a
and 300a–8 of this title, amending sections 300, 300a–1 to
300a–4 of this title, and repealing section 3505c of this
title] may be cited as the ‘Family Planning and Population Research Act of 1975’.’’
Pub. L. 94–63, title IX, § 901(a), July 29, 1975, 89 Stat.
354, provided that: ‘‘This title [enacting sections 296j to
296m and 298b–3 of this title, amending sections 296 to
296i, 297 to 297e, 297g to 297h, 298 to 298b–2, 298c, 298c–1
and 298c–7 of this title, repealing sections 296g, 296i,
297f, 298c–7, and 298c–8 of this title, and enacting provisions set out as notes under sections 296, 296a, 296d,
296e, 296m, 297, and 297b of this title and former section
297f of this title] may be cited as the ‘Nurse Training
Act of 1975’.’’
Pub. L. 93–641, § 1, Jan. 4, 1975, 88 Stat. 2225, provided
that: ‘‘This Act [enacting subchapter XIII of this chapter amending section 300e–4 of this title, repealing section 247a of this title, and enacting provisions set out
as notes under sections 217a, 229, 291b, 300l–4, and 300m
of this title] may be cited as the ‘National Health Planning and Resources Development Act of 1974’.’’
SHORT TITLE OF 1974 AMENDMENTS
Pub. L. 93–640, § 1, Jan. 4, 1975, 88 Stat. 2217, provided
that: ‘‘This Act [enacting sections 289c–4, 289c–5, and
289c–6 of this title, amending sections 289a and 289c–1 of
this title, and enacting provisions set out as notes
under section 289c–1 of this title] may be cited as the
‘National Arthritis Act of 1974’.’’
Pub. L. 93–523, § 1, Dec. 16, 1974, 88 Stat. 1660, as
amended by Pub. L. 104–182, title V, § 501(e), Aug. 6, 1996,
110 Stat. 1691, provided that: ‘‘This Act [enacting subchapter XII of this chapter and section 349 of Title 21,
Food and Drugs, amending this section, and enacting
provisions set out as a note under section 300f of this
title] may be cited as the ‘Safe Drinking Water Act of
1974’.’’
Pub. L. 93–354, § 1, July 23, 1974, 88 Stat. 373, provided
that: ‘‘This Act [enacting sections 289c–1a, 289c–2, and
289c–3 of this title, amending sections 247b and 289c–1 of
this title, and enacting provisions set out as notes
under section 289c–2 of this title] may be cited as the
‘National Diabetes Mellitus Research and Education
Act’.’’
Pub. L. 93–353, § 1(a), July 23, 1974, 88 Stat. 362, provided that: ‘‘This Act [enacting sections 242k, 242m to
242o, and 253b of this title, renumbering former sections
242i, 242j, 242f, 242d, 242g, and 242h as sections 235, 236,
242l, 244–1, 245a, and 247d of this title, amending sections 236, 242b, 242c, 242l, 244–1, 245a, 280b, 280b–1, 280b–2,
280b–4, 280b–5, and 280b–7 to 280b–9, and repealing sections 242e, 244, 244a, 245, 247, 280b–3, and 280b–12 of this
title, and enacting provisions set out as notes under
sections 242m, 253b, and 280b of this title] may be cited
as the ‘Health Services Research, Health Statistics,
and Medical Libraries Act of 1974’.’’
Pub. L. 93–353, title I, § 101, July 23, 1974, 88 Stat. 362,
provided that: ‘‘This title [enacting sections 242k, 242m
to 242o, and 253b, renumbering former sections 242i,
242j, 242f, 242d, 242g, and 242h as sections 235, 236, 242l,
244–1, 245a, and 247d of this title, amending sections 236,
242b, 242c, 242l, 244–1, and 245a, repealing sections 242e,
244, 244a, 245, and 247 of this title, and enacting provisions set out as notes under sections 242m and 253b of
this title] may be cited as the ‘Health Services Research and Evaluation and Health Statistics Act of
1974’.’’

§ 201

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 93–352, title I, § 101, July 23, 1974, 88 Stat. 358,
provided that: ‘‘This title [enacting section 289l–4 of
this title, amending sections 241, 282, 286a, 286b, 286c,
286d, 286g, and 289l of this title, enacting provisions set
out as notes under sections 289l and 289l–1 of this title,
and amending provisions set out as a note under this
section] may be cited as the ‘National Cancer Act
Amendments of 1974’.’’
Pub. L. 93–348, title I, § 1, July 12, 1974, 88 Stat. 342,
provided that: ‘‘This Act [enacting sections 289l–1 to
289l–3 of this title, amending sections 218, 241, 242a, 282,
286a, 286b, 287a, 287b, 287d, 288a, 289c, 289c–1, 289g, 289k,
and 300a–7 of this title, and enacting provisions set out
as notes under sections 218, 241, 289l–1, and 289l–3 of this
title] may be cited as the ‘National Research Act’.’’
Pub. L. 93–348, title I, § 101, July 12, 1974, 88 Stat. 342,
provided that: ‘‘This title [enacting sections 289l–1 and
289l–2 and amending sections 241, 242a, 282, 286a, 286b,
287a, 287b, 287d, 288a, 289c, 289c–1, 289g, 289k, 295f–3, and
295h–9 of this title] may be cited as the ‘National Research Service Award Act of 1974’.’’
Pub. L. 93–296, § 1, May 31, 1974, 88 Stat. 184, provided
that: ‘‘This Act [enacting Part H of subchapter III of
this chapter and provisions set out as notes under section 289k–2 of this title] may be cited as the ‘Research
on Aging Act of 1974’.’’
Pub. L. 93–270, § 1, Apr. 22, 1974, 88 Stat. 90, provided
that: ‘‘This Act [enacting part B of subchapter IX of
this chapter, amending sections 289d and 289g of this
title, and enacting provisions set out as a note under
section 289g of this title] may be cited as the ‘Sudden
Infant Death Syndrome Act of 1974’.’’
SHORT TITLE OF 1973 AMENDMENTS
Pub. L. 93–222, § 1, Dec. 29, 1973, 87 Stat. 914, provided
in part that Pub. L. 93–222 [enacting subchapter XI of
this chapter and section 280c of this title, amending
section 2001 of this title and section 172 of Title 12,
Bank and Banking, repealing section 763c of Title 33,
Navigation and Navigable Waters, enacting provisions
set out as notes under sections 300e and 300e–1 of this
title, amending provisions set out as notes under this
section, and repealing provisions set out as notes under
this section and sections 211a, 212a, and 222 of this title]
shall be cited as the ‘‘Health Maintenance Organization
Act of 1973.’’
Pub. L. 93–154, § 1, Nov. 16, 1973, 87 Stat. 594, provided
that: ‘‘This Act [enacting subchapter X of this chapter
and section 295f–6 of this title, amending sections 295f–2
and 295f–4 of this title, and enacting provisions set out
as a note under this section] may be cited as the ‘Emergency Medical Services Systems Act of 1973’.’’
Pub. L. 93–45, § 1, June 18, 1973, 87 Stat. 91, provided
that: ‘‘This Act [enacting section 300a–7 of this title,
amending sections 242b, 242c, 244–1, 245a, 246, 280b–4,
280b–5 280b–7, 280b–8, 280b–9, 291a, 291j–1, 291j–5, 295h–1,
295h–2, 295h–3a, 299a, 300, 300a–1, 300a–2, 300a–3, 2661, 2671,
2677, 2681, 2687, 2688a, 2688d, 2688j–1, 2688j–2, 2688l, 2688l–1,
2688n–1, 2688o, and 2688u of this title, and enacting provisions set out as amendment to note provisions under
this section] may be cited as the ‘Health Programs Extension Act of 1973’.’’
SHORT TITLE OF 1972 AMENDMENTS
Pub. L. 92–585, § 1, Oct. 27, 1972, 86 Stat. 1290, provided
that: ‘‘This Act [enacting section 234 of this title,
amending sections 254b and 294a of this title, and enacting provisions set out as a note under section 246 of this
title] may be cited as the ‘Emergency Health Personnel
Act Amendments of 1972’.’’
Pub. L. 92–449, § 1, Sept. 30, 1972, 86 Stat. 748, provided
that: ‘‘This Act [enacting section 247c of this title,
amending sections 247b and 300 of this title, and enacting provisions set out as notes under section 247c of
this title] may be cited as the ‘Communicable Disease
Control Amendments Act of 1972’.’’
Pub. L. 92–449, title II, § 201, Sept. 30, 1972, 86 Stat. 750,
provided that: ‘‘This title [enacting section 247c of this
title and provisions set out as notes under section 247c

Page 44

of this title] may be cited as the ‘National Venereal
Disease Prevention and Control Act’.’’
Pub. L. 92–423, § 1, Sept. 19, 1972, 86 Stat. 679, provided
that: ‘‘This Act [enacting sections 287b to 287f and 287i
of this title, amending sections 218, 241, 287, 287a, 287g,
and 287h of this title, and enacting provisions set out as
notes under section 287 of this title] may be cited as the
‘National Heart, Blood Vessel, Lung, and Blood Act of
1972’.’’
SHORT TITLE OF 1971 AMENDMENTS
Pub. L. 92–218, § 1, Dec. 23, 1971, 85 Stat. 778, provided
that: ‘‘This Act [enacting sections 286a to 286g and 289l
of this title, amending sections 218, 241, 282, 283, and 284
of this title, and enacting provisions set out as notes
under sections 281, 286, and 289l of this title] may be
cited as ‘The National Cancer Act of 1971’.’’
Pub. L. 92–158, § 1(a), Nov. 18, 1971, 85 Stat. 465, provided that: ‘‘This Act [enacting sections 296h, 296i, 297i,
298b–1, and 298b–2 of this title, amending sections 296,
296a, 296b, 296c, 296d, 296e, 296f, 296g, 297, 297a, 297b, 297c,
297e, 297f, 298, 298b, 298c, and 298c–7 of this title and enacting provisions set out as notes under sections 296,
296a, 296d, 296e, 297b, and 298c of this title] may be cited
as the ‘Nurse Training Act of 1971’.’’
Pub. L. 92–157, title I, § 101(a), Nov. 18, 1971, 85 Stat.
431, provided that: ‘‘This title [enacting sections 293i,
294g, 295e–1 to 295e–5, 295f–5, 295g–11, 295g–21 to 295g–23,
and 3505d of this title, amending sections 210 to 218,
242i, 254, 276, 277, 280, 280a–1, 292b, 292d to 292f, 292h to
292j, 293 to 293e, 293g, 293h, 294 to 294f, 295f to 295f–4,
295g, 295g–1, 295h–3d, 295h–4, 295h–8, 295h–9, 1857c–6,
1857c–8, 1857f–6c, 1857h–5, and 2676 of this title and section 346a of Title 21, Food and Drugs, and enacting provisions set out as notes under section 295h–8 of this
title] may be cited as the ‘Comprehensive Health Manpower Training Act of 1971’.’’
SHORT TITLE OF 1970 AMENDMENTS
Pub. L. 91–623, § 1, Dec. 31, 1970, 84 Stat. 1868, provided:
‘‘That this Act [enacting sections 233 and 254b of this
title] may be cited as the ‘Emergency Health Personnel
Act of 1970’.’’
Pub. L. 91–572, § 1, Dec. 24. 1970, 84 Stat. 1504, provided
that: ‘‘This Act [enacting sections 300 to 300a–6 and
3505a to 3505c of this title, amending sections 211a, 212a
of this title and section 763c of Title 33, Navigation and
Navigable Waters, and enacting provisions set out as
notes under sections 201, 222, and 300 of this title] may
be cited as the ‘Family Planning Services and Population Research Act of 1970’.’’
Pub. L. 91–519, § 1, Nov. 2, 1970, 84 Stat. 1342, provided
that: ‘‘This Act [enacting sections 295h–3a to 295h–3d,
295h–8, and 296h–9 of this title, amending sections
295f–1, 295f–2, 295h to 295h–2, 295h–4, and 295h–7 of this
title, repealing section 295h–3 of this title, and enacting
provisions set out as notes under sections 295f–1, 295–f2,
and 295h–4 of this title] may be cited as the ‘Health
Training Improvement Act of 1970’.’’
Pub. L. 91–515, title I, § 101, Oct. 30, 1970, 84 Stat. 1297,
provided that: ‘‘This title [amending sections 299 to
299g, 299i, and 299j of this title] may be cited as the
‘Heart Disease, Cancer, Stroke, and Kidney Disease
Amendments of 1970’.’’
Pub. L. 91–464, § 1, Oct. 16, 1970, 84 Stat. 988, provided:
‘‘That this Act [amending section 247b of this title]
may be cited as the ‘Communicable Disease Control
Amendments of 1970’.’’
Pub. L. 91–296, § 1(a), June 30, 1970, 84 Stat. 336, provided that: ‘‘This Act [enacting sections 229b, 291j–1 to
291j–10, and 291o–1 of this title, amending sections 291a,
242b, 245a, 246, 291 note, 291b, 291c, 291d, 291e, 291f, 291i,
291k to 291m–1, 291o, and 299a of this title and section
1717 of Title 12, Banks and Banking, enacting provisions set out as notes under this section and sections
242, 245a, 246, 291a, 291b, 291c, 291e, 291f, 291o, 295h–6, and
2688p of this title, and repealing sections 295h–6 and
2688p of this title] may be cited as the ‘Medical Facilities Construction and Modernization Amendments of
1970’.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 1 of Pub. L. 91–212 provided that: ‘‘This Act
[enacting section 280b–12 of this title and amending this
section and sections 276 to 278, 280, 280a–1, 280b, 280b–2
to 280b–9, and 280b–11 of this title] may be cited as the
‘Medical Library Assistance Extension Act of 1970’.’’
SHORT TITLE OF 1968 AMENDMENTS
Pub. L. 90–574, title IV, § 401, Oct. 15, 1968, 82 Stat.
1011, provided that: ‘‘This title [amending sections 291a
and 291b of this title] may be cited as the ‘Hospital and
Medical Facilities Construction and Modernization Assistance Amendments of 1968’.’’
Pub. L. 90–490, § 1, Aug. 16, 1968, 82 Stat. 773, provided:
‘‘That this Act [enacting sections 294f, 295g–1, 295h–6,
295h–7, 296f, 296g, and 297h of this title, amending sections 242d, 242g, 292b to 292e, 293 to 293d, 294 to 294d, 295f
to 295f–4, 295g, 295h to 295h–3, 296 to 296b, 296d, 296e, 297
to 297f, 298b, 298c, and 298c–1 of this title, omitting sections 298c–2 to 298c–6 of this title, and enacting provisions set out as notes under sections 292b, 292e, 293 to
293c, 294f, 295f, 295f–2, 295g, 296, 296d, 296f, and 297a of
this title] may be cited as the ‘Health Manpower Act of
1968’.’’
SHORT TITLE OF 1967 AMENDMENTS
Pub. L. 90–174, § 1, Dec. 5, 1967, 81 Stat. 533, provided:
‘‘That this Act [enacting sections 217b, 254a, 263a, and
291m–1 of this title, amending sections 241, 242, 242b,
243, 244, 246, 249, 251, 293e, 295h–4, and 296e of this title,
repealing section 291n of this title, and enacting provisions set out as notes under this section and sections
242b, 242c, 246, 263a, and 296e of this title] may be cited
as the ‘Partnership for Health Amendments of 1967’.’’
Pub. L. 90–174, § 5(c), Dec. 5, 1967, 81 Stat. 539, provided
that: ‘‘This section [enacting section 263a of this title
and provisions set out as notes under section 263a of
this title] may be cited as the ‘Clinical Laboratories
Improvement Act of 1967’.’’
Pub. L. 90–31, § 1, June 24, 1967, 81 Stat. 79, provided:
‘‘That this Act [enacting section 225a of this title and
amending sections 2681, 2684, 2687, 2688a, 2688d, and 2691
of this title] may be cited as the ‘Mental Health
Amendments of 1967’.’’
SHORT TITLE OF 1966 AMENDMENTS
Pub. L. 89–751, § 1, Nov. 3, 1966, 80 Stat. 1222, provided:
‘‘That this Act [enacting sections 295h to 295h–5 and
298c to 298c–8 of this title, amending sections 292b, 294d,
294n to 294p, 296, 297c to 297f, and 298 of this title and
section 1717 of Title 12, Banks and Banking, and enacting provisions set out as notes under sections 294, 294d,
297c, and 297f of this title] may be cited as the ‘Allied
Health Professions Personnel Training Act of 1966’.’’
Pub. L. 89–749, § 1, Nov. 3, 1966, 80 Stat. 1180, provided:
‘‘That this Act [amending 243, 245a, and 246 of this title,
repealing sections 247a and 247c of this title, and enacting provisions set out as notes under this section and
sections 243 and 245a of this title] may be cited as the
‘Comprehensive Health Planning and Public Health
Services Amendments of 1966’.’’
Pub. L. 89–709, § 1, Nov. 2, 1966, 80 Stat. 1103, provided:
‘‘That this Act [amending sections 293, 293a, 293d, 293e,
294, 294a, and 294b of this title] may be cited as the
‘Veterinary Medical Education Act of 1966’.’’
SHORT TITLE OF 1965 AMENDMENTS
Section 1 of Pub. L. 89–291, Oct. 22, 1965, 79 Stat. 1059,
provided that: ‘‘This Act [enacting section 280a–1 of
this title and Part J of subchapter II of this chapter
and amending section 277 of this title] may be cited as
the ‘Medical Library Assistance Act of 1965’.’’
Pub. L. 89–290, § 1, Oct. 22, 1965, 79 Stat. 1052, provided
that: ‘‘This Act [enacting sections 295f to 295f–4 and
295g of this title and amending sections 293, 293a, 293d,
294 to 294d, 297b, and 298b of this title] may be cited as
the ‘Health Professions Educational Assistance Amendments of 1965’.’’
Pub. L. 89–239, § 1, Oct. 6, 1965, 79 Stat. 926, provided:
‘‘That this Act [enacting sections 299 to 299i of this

§ 201

title, amending sections 211a and 212a of this title, sections 757, 790, 800 of former Title 5, Executive Departments and Government Officers and Employees, and
section 763c of Title 33, Navigation and Navigable Waters, and enacting provisions set out as notes under
sections 201, 214, 222, and 249 of this title] may be cited
as the ‘Heart Disease, Cancer, and Stroke Amendments
of 1965’.’’
Pub. L. 89–115, § 1, Aug. 9, 1965, 79 Stat. 448, provided:
‘‘That this Act [amending sections 241, 292c, and 292d of
this title and section 2211 of former Title 5, Executive
Departments and Government Officers and Employees,
and enacting section 623h of former Title 5 and provisions set out as a note thereunder] may be cited as the
‘Health Research Facilities Amendments of 1965’.’’
Pub. L. 89–109, § 1, Aug. 5, 1965, 79 Stat. 435, provided:
‘‘That this Act [amending sections 246, 247a, 247b, and
247d of this title] may be cited as the ‘Community
Health Services Extension Amendments of 1965’.’’
SHORT TITLE OF 1964 AMENDMENTS
Pub. L. 88–581, § 1, Sept. 4, 1964, 78 Stat. 908, provided:
‘‘That this Act [enacting subchapter VI of this chapter,
amending sections 291c, 291o, 293, 293a, 293e, and 293h of
this title, and enacting provisions set out as notes
under sections 201, 211a, 212a, 222, 291c, 293, 293e, and
293h of this title, sections 757, 790, and 800 of former
Title 5, Executive Departments and Government Officers and Employees, and section 763c of Title 33, Navigation and Navigable Waters] may be cited as the
‘Nurse Training Act of 1964’.’’
Pub. L. 88–497, § 1, Aug. 27, 1964, 78 Stat. 613, provided
that: ‘‘This Act [amending sections 244–1 and 245a of
this title] may be cited as the ‘Graduate Public Health
Training Amendments of 1964’.’’
Pub. L. 88–443, § 1, Aug. 18, 1964, 78 Stat. 447, provided
that: ‘‘This Act [enacting sections 247c, 291 to 291j, 291k
to 291m, 291n, and 291o of this title and enacting provisions set out as notes under section 291 of this title]
may be cited as the ‘Hospital and Medical Facilities
Amendments of 1964’.’’
SHORT TITLE OF 1963 AMENDMENT
Pub. L. 88–129, § 1, Sept. 24, 1963, 77 Stat. 164, provided:
‘‘That this Act [enacting sections 292j, 293 to 293h, and
294 to 294e and amending sections 292 to 292b and 292d
to 292i of this title] may be cited as the ‘Health Professions Educational Assistance Act of 1963’.’’
SHORT TITLE OF 1962 AMENDMENT
Pub. L. 87–868, § 1, Oct. 23, 1962, 76 Stat. 1155, provided
that this Act [enacting section 247b of this title] may
be cited as the ‘‘Vaccination Assistance Act of 1962.’’
SHORT TITLE OF 1961 AMENDMENT
Pub. L. 87–395, § 1, Oct. 5, 1961, 75 Stat. 824, provided:
‘‘That this Act [enacting section 247a of this title,
amending sections 246, 289c, 291i, 291n, 291s, 291t, 291w,
and 292c to 292g of this title, and enacting provisions
set out as a note under section 291s of this title] may
be cited as the ‘Community Health Services and Facilities Act of 1961’.’’
SHORT TITLE OF 1960 AMENDMENT
Section 1 of Pub. L. 86–415, Apr. 8, 1960, 74 Stat. 32,
provided: ‘‘That this Act [amending this section and
sections 209, 210, 211, 212, 253, and 415 of this title and
section 2251 of former Title 5, Executive Departments
and Government Officers and Employees, and enacting
provisions set out as notes under sections 209 and 212 of
this title and section 2253 of former Title 5] may be
cited as the ‘Public Health Service Commissioned
Corps Personnel Act of 1960’.’’
SHORT TITLE OF 1956 AMENDMENTS
Section 2 of act Aug. 3, 1956, ch. 907, 70 Stat. 962, provided that: ‘‘This Act [enacting part I of subchapter II
of this chapter] may be cited as the ‘National Library
of Medicine Act’.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Act July 3, 1956, ch. 510, § 1, 70 Stat. 489, provided that:
‘‘This Act [enacting section 246 of this title, amended
section 241 of this title, and enacting provisions set out
as a note under section 246 of this title] may be cited
as the ‘National Health Survey Act’.’’
SHORT TITLE OF 1955 AMENDMENT
Joint Res. July 28, 1955, ch. 417, § 1, 69 Stat. 382, provided that: ‘‘This joint resolution [enacting section
242b of this title and provisions set out as a note under
section 242b of this title] may be cited as the ‘Mental
Health Study Act of 1955’.’’
SHORT TITLE OF 1948 AMENDMENTS
Section 1 of act June 24, 1948, provided that: ‘‘This
Act [enacting part C of subchapter III of this chapter
and amending this section and sections 210, 218, and 241
of this title] may be cited as the ‘National Dental Research Act’.’’
Section 1 of act June 16, 1948, provided that: ‘‘This
Act [enacting sections 287 to 287c of this title and
amending this section and sections 203, 206, 210, 218, 219,
241, 246, 281, 283, and 286 of this title] may be cited as
the ‘National Heart Act’.’’
SHORT TITLE OF 1946 AMENDMENT
Section 1 of act July 3, 1946, provided: ‘‘That this Act
[enacting sections 232 and 242a of this title, amending
this section and sections 209, 210, 215, 218, 219, 241, 244,
and 246 of this title, and enacting provisions set out as
a note under this section] may be cited as the ‘National
Mental Health Act’.’’
SHORT TITLE
Section 1 of act July 1, 1944, as amended by acts Aug.
13, 1946, ch. 958, § 4, 60 Stat. 1049; July 30, 1956, ch. 779,
§ 3(a), 70 Stat. 720; Sept. 4, 1964, Pub. L. 88–581, § 4(a), 78
Stat. 919; Oct. 6, 1965, Pub. L. 89–239, § 3(a), 79 Stat. 930;
Dec. 24, 1970, Pub. L. 91–572, § 6(a), 84 Stat. 1506; May 16,
1972, Pub. L. 92–294, § 3(a), 86 Stat. 137; Nov. 16, 1973,
Pub. L. 93–154, § 2(b)(1), 87 Stat. 604; Dec. 29, 1973, Pub.
L. 93–222, § 7(a), 87 Stat. 936, provided that: ‘‘This Act
[enacting this chapter] may be cited as the ‘Public
Health Service Act’.’’
Section 329 of act July 1, 1944, formerly § 310, as added
by Pub. L. 87–692, Sept. 25, 1962, 76 Stat. 592, amended
and renumbered, formerly classified to section 254b of
this title, was popularly known as the ‘‘Migrant Health
Act’’.
Section 1400 of title XIV of act July 1, 1944, as added
Aug. 6, 1996, Pub. L. 104–182, title V, § 501(e), 110 Stat.
1691, provided that: ‘‘This title [enacting subchapter
XII of this chapter] may be cited as the ‘Safe Drinking
Water Act’.’’
RENUMBERING AND REPEAL OF REPEALING ACT
Section 1313, formerly § 611, of act July 1, 1944, renumbered § 711 by act Aug. 13, 1946, ch. 958, § 5, 60 Stat. 1049;
§ 713 by act Feb. 28, 1948, ch. 83, § 9(b), 62 Stat. 47; § 813
by act July 30, 1956, ch. 779, § 3(b), 70 Stat. 720; § 913 by
Pub. L. 88–581, § 4(b), Sept. 4, 1964, 78 Stat. 919; § 1013 by
Pub. L. 89–239, § 3(b), Oct. 6, 1965, 79 Stat. 931; § 1113 by
Pub. L. 91–572, § 6(b), Dec. 24, 1970, 84 Stat. 1506, § 1213 by
Pub. L. 92–294, § 3(b), May 16, 1972, 86 Stat. 137; § 1313 by
Pub. L. 93–154, § 2(b)(2), Nov. 16, 1973, 87 Stat. 604, repealed and amended sections in this title and in Title
8, Aliens and Nationality, Title 14, Coast Guard, Title
21, Food and Drugs, Title 24, Hospitals and Asylums,
former Title 31, Money and Finance, Title 33, Navigation and Navigable Waters, former Title 34, Navy, Title
44, Public Printing and Documents, former Title 46,
Shipping, Title 48, Territories and Insular Possessions,
and former Title 49, Transportation, and was itself repealed by Pub. L. 93–222, § 7(b), Dec. 29, 1973, 87 Stat. 936.
SAVINGS PROVISION
Section 1314, formerly § 612, of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, § 5, 60 Stat. 1049;

Page 46

Feb. 28, 1948, ch. 83, § 9(b), 62 Stat. 47; July 30, 1956, ch.
779, § 3(b), 70 Stat. 720; Sept. 4, 1964, Pub. L. 88–581, § 4(b),
78 Stat. 919; Oct. 6, 1965, Pub. L. 89–239, § 3(b), 79 Stat.
931; Dec. 24, 1970, Pub. L. 91–572, § 6(b), 84 Stat. 1506; May
16, 1972, Pub. L. 92–294, § 3(b), 86 Stat. 137; Nov. 16, 1973,
Pub. L. 93–154, § 2(b)(2), 87 Stat. 604, provided that the
repeal of statutes and parts of statutes by sections 1313,
formerly § 611, of act July 1, 1944, not affect any act
done, right accruing or accrued, or suit or proceeding
had or commenced in any civil cause before such repeal, and was repealed by Pub. L. 93–222, § 7(b), Dec. 29,
1973, 87 Stat. 936.
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3, of 1966, eff. June 25, 1966, 31 F.R. 8855, 80
Stat. 1610, set out as a note under section 202 of this
title. Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by
section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
CONGRESSIONAL DECLARATION OF PURPOSE FOR COMPREHENSIVE ALCOHOL ABUSE, DRUG ABUSE, AND MENTAL HEALTH AMENDMENTS ACT OF 1988
Pub. L. 100–690, title II, § 2012, Nov. 18, 1988, 102 Stat.
4193, provided that: ‘‘The purposes of this subtitle [subtitle A (§§ 2011–2081) of title II of Pub. L. 100–690, see
Tables for classification] with respect to substance
abuse are—
‘‘(1) to prevent the transmission of the etiologic
agent for acquired immune deficiency syndrome by
ensuring that treatment services for intravenous
drug abuse are available to intravenous drug abusers;
‘‘(2) to continue the Federal Government’s partnership with the States in the development, maintenance, and improvement of community-based alcohol
and drug abuse programs;
‘‘(3) to provide financial and technical assistance to
the States and communities in their efforts to develop and maintain a core of prevention services for
the purpose of reducing the incidence of substance
abuse and the demand for alcohol and drug abuse
treatment;
‘‘(4) to assist and encourage States in the initiation
and expansion of prevention and treatment services
to underserved populations;
‘‘(5) to increase, to the greatest extent possible, the
availability and quality of treatment services so that

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

treatment on request may be provided to all individuals desiring to rid themselves of their substance
abuse problem; and
‘‘(6) to increase understanding about the extent of
alcohol abuse and other forms of drug abuse by expanding data collection activities and supporting research on the comparative cost and efficacy of substance abuse prevention and treatment services.’’
PURPOSE OF ACT JULY 3, 1946
Section 2 of act July 3, 1946, provided: ‘‘The purpose
of this Act [see Short Title of 1946 Amendment note
above] is the improvement of the mental health of the
people of the United States through the conducting of
researches, investigations, experiments, and demonstrations relating to the cause, diagnosis, and treatment of psychiatric disorders; assisting and fostering
such research activities by public and private agencies,
and promoting the coordination of all such researches
and activities and the useful application of their results; training personnel in matters relating to mental
health; and developing, and assisting States in the use
of, the most effective methods of prevention, diagnosis,
and treatment of psychiatric disorders.’’
EXISTING POSITIONS, PROCEDURES, REGULATIONS,
FUNDS, APPROPRIATIONS, AND PROPERTY
Sections 1301 to 1303, formerly §§ 601 to 603, of act July
1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, § 5,
60 Stat. 1049; July 30, 1956, ch. 779, § 3(b), 70 Stat. 720;
Sept. 3, 1964, Pub. L. 88–581, § 4(b), 78 Stat. 919; Oct. 6,
1965, Pub. L. 89–239, § 3(b), 79 Stat. 931; Dec. 24, 1970, Pub.
L. 91–572, § 6(b), 84 Stat. 1506; May 16, 1972, Pub. L.
92–294, § 3(b), 86 Stat. 137; Nov. 16, 1973, Pub. L. 93–154,
§ 2(b)(2), 87 Stat. 604, related to the effect of this chapter on existing positions, procedures, regulations,
funds, appropriations, and property, and was repealed
by Pub. L. 93–222, § 7(b), Dec. 29, 1973, 87 Stat. 936.
APPROPRIATIONS FOR EMERGENCY HEALTH AND
SANITATION ACTIVITIES
Section 1304, formerly § 604, of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, § 5, 60 Stat. 1049;
July 30, 1956, ch. 779, § 3(b), 70 Stat. 720; Sept. 4, 1964,
Pub. L. 88–581, § 4(b), 78 Stat. 919; Oct. 6, 1965, Pub. L.
89–239, § 3(b), 79 Stat. 931; Dec. 24, 1970, Pub. L. 91–572,
§ 6(b), 84 Stat. 1506; May 16, 1972, Pub. L. 92–294, § 3(b), 86
Stat. 137; Nov. 16, 1973, Pub. L. 93–154, § 2(b)(2), 87 Stat.
604, authorized annual appropriations during World War
II and during period of demobilization to conduct
health and sanitation activities in military, naval, or
industrial areas, and was repealed by Pub. L. 93–222,
§ 7(b), Dec. 29, 1973, 87 Stat. 936. Joint Res. July 25, 1947,
ch. 327, § 3, 61 Stat. 451, provided that in the interpretation of section 1004 of act July 1, 1944, the date July 25,
1947, shall be deemed to be the date of termination of
any state of war theretofore declared by Congress and
of the national emergencies proclaimed by the President on September 8, 1939, and May 27, 1941.
AVAILABILITY OF APPROPRIATIONS
Pub. L. 91–296, title VI, § 601, June 30, 1970, 84 Stat.
353, as amended Pub. L. 93–45, title IV, § 401(a), June 18,
1973, 87 Stat. 95; Pub. L. 93–352, title I, § 113, July 23,
1974, 88 Stat. 360, provided that: ‘‘Notwithstanding any
other provision of law, unless enacted after the enactment of this Act [June 30, 1970] expressly in limitation
of the provisions of this section, funds appropriated for
any fiscal year to carry out any program for which appropriations are authorized by the Public Health Service Act (Public Law 410, Seventy-eighth Congress, as
amended) [this chapter] or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963 (Public Law 88–164, as amended)
[sections 2689 et seq. and 6001 et seq. of this title] shall
remain available for obligation and expenditure until
the end of such fiscal year.’’
FEDERAL ACCOUNTABILITY
Pub. L. 102–321, title II, § 203(b), July 10, 1992, 106 Stat.
410, provided that: ‘‘Any rule or regulation of the De-

§ 201

partment of Health and Human Services that is inconsistent with the amendments made by this Act [see
Tables for classification] shall not have any legal effect, including section 50(e) of part 96 of title 45, Code
of Federal Regulations (45 CFR 96.50(e)).’’
HAZARDOUS SUBSTANCES
Federal Hazardous Substances Act as not modifying
this chapter, see Pub. L. 86–613, § 18, July 12, 1960, 74
Stat. 380, set out as a note under section 1261 of Title
15, Commerce and Trade.
DEFINITION OF ‘‘SECRETARY’’
Pub. L. 90–574, title V, § 507, Oct. 15, 1968, 82 Stat. 1013,
as amended by Pub. L. 96–88, title V, § 509(b), 93 Stat.
695, provided that: ‘‘As used in the amendments made
by this Act [enacting sections 229a, 299j, 2688e to 2688q,
and 2697a of this title, amending sections 210g, 242h,
291a, 291b, 299a to 299e, 2693, and 3259 of this title, repealing section 3442 of this title, and enacting provisions set out as notes under sections 291a, 2688e, 3442 of
this title, section 278 of Title 22, Foreign Relations and
Intercourse, and section 3681 of Title 38, Veterans’ Benefits], the term ‘Secretary’ means the Secretary of
Health and Human Services.’’
Pub. L. 90–174, § 15, Dec. 5, 1967, 81 Stat. 542, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695, provided that: ‘‘As used in the amendments
made by this Act [enacting sections 217b, 243(c), 251(b),
254a, 263a, and 291m–1 and amending sections 242b,
242g(c), 246(d)(1), (e), and 296e(c)(1) of this title] the
term ‘Secretary’ means the Secretary of Health and
Human Services.’’
EX. ORD. NO. 13507. ESTABLISHMENT OF THE WHITE HOUSE
OFFICE OF HEALTH REFORM
Ex. Ord. No. 13507, Apr. 8, 2009, 74 F.R. 17071, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, and in the interest of providing all Americans
access to affordable and high-quality health care, it is
hereby ordered as follows:
SECTION 1. Policy. Reforming the health care system
is a key goal of my Administration. The health care
system suffers from serious and pervasive problems; access to health care is constrained by high and rising
costs; and the quality of care is not consistent and
must be improved, in order to improve the health of
our citizens and our economic security.
SEC. 2. Establishment. (a) There is established a White
House Office of Health Reform (Health Reform Office)
within the Executive Office of the President that will
provide leadership to the executive branch in establishing policies, priorities, and objectives for the Federal
Government’s comprehensive effort to improve access
to health care, the quality of such care, and the sustainability of the health care system.
(b) The Secretary of Health and Human Services, to
the extent permitted by law, shall establish within the
Department of Health and Human Services (HHS) an
Office of Health Reform, which shall coordinate closely
with the White House Office of Health Reform.
SEC. 3. Functions. The principal functions of the
Health Reform Office, to the extent permitted by law,
are to:
(a) provide leadership for and to coordinate the development of the Administration’s policy agenda across
executive departments and agencies concerning the
provision of high-quality, affordable, and accessible
health care and to slow the growth of health costs; this
shall include coordinating policy development with the
Domestic Policy Council, National Economic Council,
Council of Economic Advisers, Office of Management
and Budget, HHS, Office of Personnel Management, and
such other executive departments and agencies as the
Director of the Health Reform Office may deem appropriate;
(b) work with executive departments and agencies to
ensure that Federal Government policy decisions and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

programs are consistent with the President’s stated
goals with respect to health reform;
(c) integrate the President’s policy agenda concerning health reform across the Federal Government;
(d) coordinate public outreach activities conducted
by executive departments and agencies designed to
gather input from the public, from demonstration and
pilot projects, and from public-private partnerships on
the problems and priorities for policy measures designed to meet the President’s goals for improvement
of the health care system;
(e) bring to the President’s attention concerns, ideas,
and policy options for strengthening, increasing the efficiency, and improving the quality of the health care
system;
(f) work with State, local, and community policymakers and public officials to expand coverage, improve quality and efficiency, and slow the growth of
health costs;
(g) develop and implement strategic initiatives under
the President’s agenda to strengthen the public agencies and private organizations that can improve the
performance of the health care system;
(h) work with the Congress and executive departments and agencies to eliminate unnecessary legislative, regulatory, and other bureaucratic barriers that
impede effective delivery of efficient and high-quality
health care;
(i) monitor implementation of the President’s agenda
on health reform; and
(j) help ensure that policymakers across the executive branch work toward the President’s health care
agenda.
SEC. 4. Administration. (a) The Health Reform Office
may work with established or ad hoc committees, task
forces, or interagency groups.
(b) The Health Reform Office shall have a staff headed by the Director of the Health Reform Office (Director). The Health Reform Office shall have such staff
and other assistance as may be necessary to carry out
the provisions of this order.
(c) As requested by the Director, each executive department and agency shall designate a liaison to work
with the Health Reform Office on improving access to
health care, the quality of health care, and the sustainability of the health care system.
(d) All executive departments and agencies shall cooperate with the Health Reform Office and provide such
information, support, and assistance to the Health Reform Office as it may request, to the extent permitted
by law.
SEC. 5. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) authority granted by law to a department, agency,
or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
BARACK OBAMA.

PART A—ADMINISTRATION
§ 202. Administration and supervision of Service
The Public Health Service in the Department
of Health and Human Services shall be administered by the Assistant Secretary for Health
under the supervision and direction of the Secretary.
(July 1, 1944, ch. 373, title II, § 201, 58 Stat. 683;
1953 Reorg. Plan No. 1, §§ 5, 8 eff. Apr. 11, 1953, 18

Page 48

F.R. 2053, 67 Stat. 631; Pub. L. 103–43, title XX,
§ 2008(f), June 10, 1993, 107 Stat. 212.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘Health and Human
Services’’ for ‘‘Health, Education, and Welfare’’ and
‘‘Assistant Secretary for Health’’ for ‘‘Surgeon General’’.
TRANSFER OF FUNCTIONS
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
INTERNATIONAL HEALTH ADMINISTRATION
Ex. Ord. No. 10399, Sept. 27, 1952, 17 F.R. 8648, designated Surgeon General to perform certain duties
under International Sanitary Regulations of World
Health Organization.
REORGANIZATION PLAN NO. 3 OF 1966
Eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610
Prepared by the President and transmitted to the Senate and the House of Representatives in Congress assembled, April 25, 1966, pursuant to the provisions of
the Reorganization Act of 1949, 63 Stat. 203, as amended [see 5 U.S.C. 901 et seq.].
PUBLIC HEALTH SERVICE
SECTION 1. TRANSFER OF FUNCTIONS
(a) Except as otherwise provided in subsection (b) of
this section, there are hereby transferred to the Secretary of Health, Education, and Welfare (hereinafter
referred to as the Secretary) all functions of the Public
Health Service, of the Surgeon General of the Public
Health Service, and of all other officers and employees
of the Public Health Service, and all functions of all
agencies of or in the Public Health Service.
(b) This section shall not apply to the functions vested by law in any advisory council, board, or committee
of or in the Public Health Service which is established
by law or is required by law to be established.
SEC. 2. PERFORMANCE OF TRANSFERRED FUNCTIONS
The Secretary may from time to time make such provisions as he shall deem appropriate authorizing the
performance of any of the functions transferred to him
by the provisions of this reorganization plan by any officer, employee, or agency of the Public Health Service
or of the Department of Health, Education, and Welfare.
SEC. 3. ABOLITIONS
(a) The following agencies of the Public Health Service are hereby abolished:
(1) The Bureau of Medical Services, including the office of Chief of the Bureau of Medical Services.
(2) The Bureau of State Services, including the office
of Chief of the Bureau of State Services.
(3) The agency designated as the National Institutes
of Health (42 U.S.C. 203), including the office of Director
of the National Institutes of Health (42 U.S.C. 206(b))
but excluding the several research Institutes in the
agency designated as the National Institutes of Health.
(4) The agency designated as the Office of the Surgeon General (42 U.S.C. 203(1)), together with the office
held by the Deputy Surgeon General (42 U.S.C. 206(a)).
(b) The Secretary shall make such provisions as he
shall deem necessary respecting the winding up of any

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

outstanding affairs of the agencies abolished by the
provisions of this section.
SEC. 4. INCIDENTAL TRANSFERS
As he may deem necessary in order to carry out the
provisions of this reorganization plan, the Secretary
may from time to time effect transfers within the Department of Health, Education, and Welfare of any of
the records, property, personnel and unexpended balances (available or to be made available) of appropriations, allocations, and other funds of the Department
which relate to functions affected by this reorganization plan.
[The Secretary and Department of Health, Education,
and Welfare were redesignated the Secretary and Department of Health and Human Services, respectively,
by 20 U.S.C. 3508.]
MESSAGE OF THE PRESIDENT
To the Congress of the United States:
I transmit herewith Reorganization Plan No. 3 of
1966, prepared in accordance with the Reorganization
Act of 1949, as amended, and providing for reorganization of health functions of the Department of Health,
Education, and Welfare.
I
Today we face new challenges and unparalleled opportunities in the field of health. Building on the
progress of the past several years, we have truly begun
to match the achievements of our medicine to the
needs of our people.
The task ahead is immense. As a nation, we will unceasingly pursue our research and learning, our training and building, our testing and treatment. But now
our concern must also turn to the organization of our
Federal health programs.
As citizens we are entitled to the very best health
services our resources can provide.
As taxpayers, we demand the most efficient and economic health organizations that can be devised.
I ask the Congress to approve a reorganization plan
to bring new strength to the administration of Federal
health programs.
I propose a series of changes in the organization of
the Public Health Service that will bring to all Americans a structure modern in design, more efficient in operation and better prepared to meet the great and
growing needs of the future. Through such improvements we can achieve the full promise of the landmark
health legislation enacted by the 89th Congress.
I do not propose these changes lightly. They follow a
period of careful deliberation. For many months the
Secretary of Health, Education, and Welfare, and the
Surgeon General have consulted leading experts in the
Nation—physicians, administrators, scientists, and
public health specialists. They have confirmed my belief that modernization and reorganization of the Public Health Service are urgently required and long overdue.
II
The Public Health Service is an operating agency of
the Department of Health, Education, and Welfare. It is
the principal arm of the Federal Government in the
field of health. Its programs are among those most
vital to our well-being.
Since 1953 more than 50 new programs have been
placed in the Public Health Service. Its budget over the
past 12 years has increased tenfold—from $250 million
to $2.4 billion.
Today the organization of the Public Health Service
is clearly obsolete. The requirement that new and expanding programs be administered through an organizational structure established by law more than two
decades ago stands as a major obstacle to the fulfillment of our Nation’s health goals.
As presently constituted, the Public Health Service is
composed of four major components:

§ 202

National Institutes of Health.
Bureau of State Services.
Bureau of Medical Services.
Office of the Surgeon General.
Under present law, Public Health Service functions
must be assigned only to these four components.
This structure was designed to provide separate administrative arrangements for health research, programs of State and local aid, health services, and executive staff resources. At a time when these functions
could be neatly compartmentalized, the structure was
adequate. But today the situation is different.
Under recent legislation many new programs provide
for an integrated attack on specific disease problems or
health hazards in the environment by combining health
services, State and local aid, and research. Each new
program of this type necessarily is assigned to one of
the three operating components of the Public Health
Service. Yet none of these components is intended to
administer programs involving such a variety of approaches.
Our health problems are difficult enough without
having them complicated by outmoded organizational
arrangements.
But if we merely take the step of integrating the four
agencies within the Public Health Service we will not
go far enough. More is required.
III
The Department of Health, Education, and Welfare
performs major health or health-related functions
which are not carried out through the Public Health
Service, although they are closely related to its functions. Among these are:
Health insurance for the aged, administered
through the Social Security Administration;
Medical assistance for the needy, administered
through the Welfare Administration;
Regulation of the manufacture, labeling, and distribution of drugs, carried out through the Food and
Drug Administration; and
Grants-in-aid to States for vocational rehabilitation of the handicapped, administered by the Vocational Rehabilitation Administration.
Expenditures for health and health-related programs
of the Department administered outside the Public
Health Service have increased from $44 million in 1953
to an estimated $5.4 billion in 1967.
As the head of the Department, the Secretary of
Health, Education, and Welfare is responsible for the
Administration and coordination of all the Department’s health functions. He has clear authority over
the programs I have just mentioned.
But today he lacks this essential authority over the
Public Health Service. The functions of that agency are
vested in the Surgeon General and not in the Secretary.
This diffusion of responsibility is unsound and unwise.
To secure the highest possible level of health services
for the American people the Secretary of Health, Education, and Welfare must be given the authority to establish—and modify as necessary—the organizational
structure for Public Health Service programs.
He must also have the authority to coordinate health
functions throughout the Department. The reorganization plan I propose will accomplish these purposes. It
will provide the Secretary with the flexibility to create
new and responsive organizational arrangements to
keep pace with the changing and dynamic nature of our
health programs.
My views in this respect follow a basic principle of
good government set by the Hoover Commission in 1949
when it recommended that ‘‘the Department head
should be given authority to determine the organization within his Department.’’
IV
In summary, the reorganization plan would:

§ 203

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Transfer to the Secretary of Health, Education, and
Welfare the functions now vested in the Surgeon General of the Public Health Service and in its various
subordinate units (this transfer will not affect certain statutory advisory bodies such as the National
Advisory Cancer and Heart Councils);
Abolish the four principal statutory components of
the Public Health Service, including the offices held
by their heads (the Bureau of Medical Services, the
Bureau of State Services, the National Institutes of
Health exclusive of its several research institutes
such as the National Cancer and Heart Institutes, and
the Office of the Surgeon General); and
Authorize the Secretary to assign the functions
transferred to him by the plan to officials and entities of the Public Health Service and to other agencies of the Department as he deems appropriate.
Thus, the Secretary would be—
Enabled to assure that all health functions of the
Department are carried out as effectively and economically as possible;
Given authority commensurate with his responsibility; and
Made responsible in fact for matters for which he is
now, in any case, held accountable by the President,
the Congress, and the people.
V
I have found, after investigation, that each reorganization included in the accompanying reorganization
plan is necessary to accomplish one or more of the purposes set forth in section 2(a) of the Reorganization Act
of 1949, as amended.
Should the reorganizations in the accompanying reorganization plan take effect, they will make possible
more effective and efficient administration of the affected health programs. It is, however, not practicable
at this time to itemize the reductions in expenditures
which may result.
I strongly recommend that the Congress allow the reorganization plan to become effective.
LYNDON B. JOHNSON.
THE WHITE HOUSE, April 25, 1966.
EXECUTIVE ORDER NO. 10506
Ex. Ord. No. 10506, Dec. 10, 1953, 18 F.R. 8219, which
delegated certain functions of the President relating to
the Public Health Service, was superseded by Ex. Ord.
No. 11140, Jan. 30, 1964, 29 F.R. 1637, set out below.
EX. ORD. NO. 11140. DELEGATION OF FUNCTIONS
Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as
amended by Ex. Ord. No. 12608, Sept. 9, 1987, 52 F.R.
34617, provided:
By virtue of the authority vested in me by Section
301 of Title 3 of the United States Code, and as President of the United States, it is ordered as follows:
SECTION 1. The Secretary of Health and Human Services is hereby authorized and empowered, without the
approval, ratification, or other action of the President,
to perform the following-described functions vested in
the President under the Public Health Service Act (58
Stat. 682), as amended [this chapter]:
(a) The authority under Section 203 (42 U.S.C. 204): to
appoint commissioned officers of the Reserve Corps.
(b) The authority under Section 206(b) (42 U.S.C.
207(b)) to prescribe titles, appropriate to the several
grades, for commissioned officers of the Public Health
Service other than medical officers.
(c) The authority under Section 207(a)(2) (42 U.S.C.
209(a)(2)) to terminate commissions of officers of the
Reserve Corps without the consent of the officers concerned.
(d) The authority under Section 210(a), (k), and (l) (42
U.S.C. 211(a), (k), and (l)) to make or terminate temporary promotions of commissioned officers of the Regular Corps and Reserve Corps.
(e) The authority under Section 211(a)(5) (42 U.S.C.
212(a)(5)) to approve voluntary retirements under that
section.

Page 50

(f) The authority to prescribe regulations under the
following-designated Sections: 207(a), 207(b), 208(e),
210(a), 210(b), 210(d)(1), 210(h), 210(i), 210(j)(1), 210(k),
215(a), 218(a), 219(a), and 510 (42 U.S.C. 209(a), 209(b),
210(e), 211(a), 211(b), 211(d)(1), 211(h), 211(i), 211(j)(1),
211(k), 216(a), 218a(a), 210–1(a), and 228).
(g) The authority under Sections 321(a) and 364(a) (42
U.S.C. 248(a) and 267(a)) to approve the selection of suitable sites for and the establishment of additional institutions, hospitals, stations, grounds, and anchorages;
subject, however, to the approval of the Director of the
Office of Management and Budget, except as he may
otherwise provide.
SEC. 2. The Surgeon General is hereby authorized and
empowered, without the approval, ratification, or other
action of the President, to perform the function vested
in the President by Sections 203 and 207(a)(2) of the
Public Health Service Act (58 Stat. 683, 685), as amended (42 U.S.C. 204 and 209(a)(2)), or otherwise, of accepting voluntary resignations of commissioned officers of
the Regular Corps or the Reserve Corps.
SEC. 3. The Secretary of Health and Human Services
is hereby authorized and empowered, without the approval, ratification, or other action of the President, to
exercise the authority vested in the President by Section 704 of Title 37 of the United States Code to prescribe regulations.
SEC. 4. The Secretary of Health and Human Services
is hereby authorized to redelegate all or any part of the
functions set forth under (a), (b), (c), and (d) of Section
1 hereof to the Surgeon General of the Public Health
Service or other official of that Service who is required
to be appointed by and with the advice and consent of
the Senate.
SEC. 5. All actions heretofore taken by appropriate
authority with respect to the matters affected by this
order and in force at the time of the issuance of this
order, including any regulations prescribed or approved
with respect to such matters, shall, except as they may
be inconsistent with the provisions of this order, remain in effect until amended, modified, or revoked pursuant to the authority conferred by this order.
SEC. 6. As used in this order, the term ‘‘functions’’
embraces duties, powers, responsibilities, authority, or
discretion, and the term ‘‘perform’’ may be construed
to mean ‘‘exercise’’.
SEC. 7. (a) Executive Order No. 10506 of December 10,
1953, entitled ‘‘Delegating Certain Functions of the
President under the Public Health Service Act,’’ is
hereby superseded.
(b) Executive Orders Nos. 9993 of August 31, 1948, 10031
of January 26, 1949, 10280 of August 16, 1951, 10354 of May
26, 1952, and 10497 of October 27, 1953, which prescribed
regulations relating to commissioned officers and employees of the Public Health Service, are hereby revoked. Nothing in this subsection shall be deemed to
alter or otherwise affect the regulations prescribed by
the Surgeon General (42 CFR Parts 21 and 22) to replace
the regulations prescribed by the orders described in
the preceding sentence.

§ 203. Organization of Service
The Service shall consist of (1) the Office of
the Surgeon General, (2) the National Institutes
of Health, (3) the Bureau of Medical Services,
and 1 (4) the Bureau of State Services, and 2 the
Agency for Healthcare Research and Quality.
The Secretary is authorized and directed to assign to the Office of the Surgeon General,3 to
the National Institutes of Health, to the Bureau
of Medical Services, and to the Bureau of State
Services, respectively, the several functions of
the Service, and to establish within them such
1 So

in original. The ‘‘and’’ probably should not appear.
in original. Probably should be followed by ‘‘(5)’’.
3 See 1993 Amendment note below.
2 So

Page 51

TITLE 42—THE PUBLIC HEALTH AND WELFARE

divisions, sections, and other units as he may
find necessary; and from time to time abolish,
transfer, and consolidate divisions, sections, and
other units and assign their functions and personnel in such manner as he may find necessary
for efficient operation of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated,
except with the approval of the Secretary. The
National Institutes of Health shall be administered as a part of the field service. The Secretary may delegate to any officer or employee
of the Service such of his powers and duties
under this chapter, except the making of regulations, as he may deem necessary or expedient.
(July 1, 1944, ch. 373, title II, § 202, 58 Stat. 683;
June 16, 1948, ch. 481, § 6(b), 62 Stat. 469; 1953
Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Pub. L. 103–43, title XX,
§ 2008(g), June 10, 1993, 107 Stat. 212; Pub. L.
106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.)
AMENDMENTS
1999—Pub. L. 106–129 substituted ‘‘Agency for Healthcare Research and Quality’’ for ‘‘Agency for Health
Care Policy and Research’’.
1993—Pub. L. 103–43, § 2008(g)(2), inserted ‘‘, and the
Agency for Health Care Policy and Research’’ in first
sentence.
Pub. L. 103–43, § 2008(g)(1), which directed the amendment of this section by striking ‘‘Surgeon General’’ the
second and subsequent times that such term appears
and inserting ‘‘Secretary’’, was executed by making the
substitution before ‘‘is authorized and directed’’ and
before ‘‘may delegate to any officer’’ and by leaving unchanged ‘‘Surgeon General’’ in the phrase ‘‘assign to
the Office of the Surgeon General’’ in second sentence,
to reflect the probable intent of Congress.
1948—Act June 16, 1948, substituted ‘‘National Institutes of Health’’ for ‘‘National Institute of Health’’ in
cl. (2).
TRANSFER OF FUNCTIONS
Bureau of Medical Services, Bureau of State Services,
National Institutes of Health, excluding several research Institutes in agency, and Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966,
eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and all functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of Reorg. Plan No. 3 of
1966, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare,
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 204. Commissioned Corps and Ready Reserve
Corps
(a) Establishment
(1) In general
There shall be in the Service a commissioned Regular Corps and a Ready Reserve

§ 204

Corps for service in time of national emergency.
(2) Requirement
All commissioned officers shall be citizens of
the United States and shall be appointed without regard to the civil-service laws and compensated without regard to the Classification
Act of 1923, as amended.
(3) Appointment
Commissioned officers of the Ready Reserve
Corps shall be appointed by the President and
commissioned officers of the Regular Corps
shall be appointed by the President with the
advice and consent of the Senate.
(4) Active duty
Commissioned officers of the Ready Reserve
Corps shall at all times be subject to call to
active duty by the Surgeon General, including
active duty for the purpose of training.
(5) Warrant officers
Warrant officers may be appointed to the
Service for the purpose of providing support to
the health and delivery systems maintained
by the Service and any warrant officer appointed to the Service shall be considered for
purposes of this chapter and title 37 to be a
commissioned officer within the Commissioned Corps of the Service.
(b) Assimilating Reserve Corps officers into the
Regular Corps
Effective on March 23, 2010, all individuals
classified as officers in the Reserve Corps under
this section (as such section existed on the day
before March 23, 2010) and serving on active duty
shall be deemed to be commissioned officers of
the Regular Corps.
(c) Purpose and use of Ready Reserve
(1) Purpose
The purpose of the Ready Reserve Corps is to
fulfill the need to have additional Commissioned Corps personnel available on short notice (similar to the uniformed service’s reserve
program) to assist regular Commissioned
Corps personnel to meet both routine public
health and emergency response missions.
(2) Uses
The Ready Reserve Corps shall—
(A) participate in routine training to meet
the general and specific needs of the Commissioned Corps;
(B) be available and ready for involuntary
calls to active duty during national emergencies and public health crises, similar to
the uniformed service reserve personnel;
(C) be available for backfilling critical positions left vacant during deployment of active duty Commissioned Corps members, as
well as for deployment to respond to public
health emergencies, both foreign and domestic; and
(D) be available for service assignment in
isolated, hardship, and medically underserved communities (as defined in section
295p of this title) to improve access to health
services.
(d) Funding
For the purpose of carrying out the duties and
responsibilities of the Commissioned Corps

§ 204a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

under this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2010
through 2014 for recruitment and training and
$12,500,000 for each of fiscal years 2010 through
2014 for the Ready Reserve Corps.
(July 1, 1944, ch. 373, title II, § 203, 58 Stat. 683;
Feb. 28, 1948, ch. 83, § 2, 62 Stat. 39; Oct. 28, 1949,
ch. 782, title XI, § 1106(a), 63 Stat. 972; Pub. L.
96–76, title III, § 302(a), Sept. 29, 1979, 93 Stat. 584;
Pub. L. 111–148, title V, § 5210, Mar. 23, 2010, 124
Stat. 614.)
REFERENCES IN TEXT
The Classification Act of 1923, as amended, referred to
in subsec. (a)(2), is act Mar. 4, 1923, ch. 265, 42 Stat. 1488,
which was classified to section 661 et seq. of former
Title 5, Executive Departments and Government Officers and Employees, and was repealed by act Oct. 28,
1949, ch. 782, title XII, § 1202, 63 Stat. 972.
AMENDMENTS
2010—Pub. L. 111–148 inserted section catchline and
amended text generally. Prior to amendment, text read
as follows: ‘‘There shall be in the Service a commissioned Regular Corps and, for the purpose of securing a
reserve for duty in the Service in time of national
emergency, a Reserve Corps. All commissioned officers
shall be citizens and shall be appointed without regard
to the civil-service laws and compensated without regard to chapter 51 and subchapter III of chapter 53 of
title 5. Commissioned officers of the Reserve Corps
shall be appointed by the President and commissioned
officers of the Regular Corps shall be appointed by him
by and with the advice and consent of the Senate. Commissioned officers of the Reserve Corps shall at all
times be subject to call to active duty by the Surgeon
General, including active duty for the purpose of training and active duty for the purpose of determining
their fitness for appointment in the Regular Corps.
Warrant officers may be appointed to the Service for
the purpose of providing support to the health and delivery systems maintained by the Service and any warrant officer appointed to the Service shall be considered for purposes of this chapter and title 37 to be a
commissioned officer within the commissioned corps of
the Service.’’
1979—Pub. L. 96–76 inserted provisions relating to appointment and status of warrant officers.
1949—Act Oct. 28, 1949, substituted ‘‘Classification Act
of 1949’’ for ‘‘Classification Act of 1923’’.
1948—Act Feb. 28, 1948, struck out provision that all
active service in Reserve Corps, as well as service in
Regular Corps, shall be credited for purpose of promotion in Regular Corps.
REPEALS
Act Oct. 28, 1949, cited as a credit to this section, was
repealed (subject to a savings clause) by Pub. L. 89–554,
Sept. 6, 1966, § 8, 80 Stat. 632, 655.
REPORTS
Pub. L. 111–148, title V, § 5701, Mar. 23, 2010, 124 Stat.
684, provided that:
‘‘(a) REPORTS BY SECRETARY OF HEALTH AND HUMAN
SERVICES.—On an annual basis, the Secretary of Health
and Human Services shall submit to the appropriate
Committees of Congress a report on the activities carried out under the amendments made by this title [see
Tables for classification], and the effectiveness of such
activities.
‘‘(b) REPORTS BY RECIPIENTS OF FUNDS.—The Secretary of Health and Human Services may require, as a
condition of receiving funds under the amendments
made by this title, that the entity receiving such award
submit to such Secretary such reports as the such Secretary may require on activities carried out with such
award, and the effectiveness of such activities.’’

Page 52

OSTEOPATHS AS RESERVE OFFICERS
Section 709 of act July 1, 1944, formerly § 609, renumbered § 709 by act Aug. 13, 1946, ch. 958, § 5, 60 Stat. 1049,
which provided for appointment of osteopaths as reserve officers until six months after World War II, was
repealed by Joint Res. July 25, 1947, ch. 327, § 1, 61 Stat.
449.
DELEGATION OF AUTHORITY TO APPOINT COMMISSIONED
OFFICERS OF THE READY RESERVE CORPS OF THE PUBLIC HEALTH SERVICE
Memorandum of President of the United States, June
1, 2010, 75 F.R. 32245, provided:
Memorandum for the Secretary of Health and Human
Services
By virtue of the authority vested in me as President
by the Constitution and the laws of the United States,
including section 301 of title 3, United States Code, I
hereby assign to you the functions of the President
under section 203 of the Public Health Service Act, as
amended by Public Law 111–148, to appoint commissioned officers of the Ready Reserve Corps. The exercise of this authority is limited to appointments of individuals who were extended offers of employment for
appointment and call to active duty in the Reserve
Corps of the Public Health Service with an appointment date subsequent to March 23, 2010, the date of enactment of Public Law 111–148, but who were not on active duty on that date, and those individuals who are
selected for the 2010 Commissioned Officer Student
Training and Extern Program. This authority may not
be re-delegated.
You are authorized and directed to publish this
memorandum in the Federal Register.
BARACK OBAMA.

§ 204a. Deployment readiness
(a) Readiness requirements for Commissioned
Corps officers
(1) In general
The Secretary, with respect to members of
the following Corps components, shall establish requirements, including training and medical examinations, to ensure the readiness of
such components to respond to urgent or
emergency public health care needs that cannot otherwise be met at the Federal, State,
and local levels:
(A) Active duty Regular Corps.
(B) Active Reserves.
(2) Annual assessment of members
The Secretary shall annually determine
whether each member of the Corps meets the
applicable readiness requirements established
under paragraph (1).
(3) Failure to meet requirements
A member of the Corps who fails to meet or
maintain the readiness requirements established under paragraph (1) or who fails to comply with orders to respond to an urgent or
emergency public health care need shall, except as provided in paragraph (4), in accordance with procedures established by the Secretary, be subject to disciplinary action as
prescribed by the Secretary.
(4) Waiver of requirements
(A) In general
The Secretary may waive one or more of
the requirements established under paragraph (1) for an individual who is not able to
meet such requirements because of—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) a disability;
(ii) a temporary medical condition; or
(iii) any other extraordinary limitation
as determined by the Secretary.
(B) Regulations
The Secretary shall promulgate regulations under which a waiver described in subparagraph (A) may be granted.
(5) Urgent or emergency public health care
need
For purposes of this section and section 215
of this title, the term ‘‘urgent or emergency
public health care need’’ means a health care
need, as determined by the Secretary, arising
as the result of—
(A) a national emergency declared by the
President under the National Emergencies
Act (50 U.S.C. 1601 et seq.);
(B) an emergency or major disaster declared by the President under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et seq.);
(C) a public health emergency declared by
the Secretary under section 247d of this
title; or
(D) any emergency that, in the judgment
of the Secretary, is appropriate for the deployment of members of the Corps.
(b) Corps management for deployment
The Secretary shall—
(1) organize members of the Corps into units
for rapid deployment by the Secretary to respond to urgent or emergency public health
care needs;
(2) establish appropriate procedures for the
command and control of units or individual
members of the Corps that are deployed at the
direction of the President or the Secretary in
response to an urgent or emergency public
health care need of national, State or local
significance;
(3) ensure that members of the Corps are
trained, equipped and otherwise prepared to
fulfill their public health and emergency response roles; and
(4) ensure that deployment planning takes
into account—
(A) any deployment exemptions that may
be granted by the Secretary based on the
unique requirements of an agency and an individual’s functional role in such agency;
and
(B) the nature of the urgent or emergency
public health care need.
(c) Deployment of detailed or assigned officers
For purposes of pay, allowances, and benefits
of a Commissioned Corps officer who is detailed
or assigned to a Federal entity, the deployment
of such officer by the Secretary in response to
an urgent or emergency public health care need
shall be deemed to be an authorized activity of
the Federal entity to which the officer is detailed or assigned.
(July 1, 1944, ch. 373, title II, § 203A, as added
Pub. L. 109–417, title II, § 206(b), Dec. 19, 2006, 120
Stat. 2851.)
REFERENCES IN TEXT
The National Emergencies Act, referred to in subsec.
(a)(5)(A), is Pub. L. 94–412, Sept. 14, 1976, 90 Stat. 1255,

§ 205

as amended, which is classified principally to chapter
34 (§ 1601 et seq.) of Title 50, War and National Defense.
For complete classification of this Act to the Code, see
Short Title note set out under section 1601 of Title 50
and Tables.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (a)(5)(B), is
Pub. L. 93–288, May 22, 1974, 88 Stat. 143, as amended,
which is classified principally to chapter 68 (§ 5121 et
seq.) of this title. For complete classification of this
Act to the Code, see Short Title note set out under section 5121 of this title and Tables.
PURPOSE
Pub. L. 109–417, title II, § 206(a), Dec. 19, 2006, 120 Stat.
2851, provided that: ‘‘It is the purpose of this section
[enacting this section and amending sections 215 and
254d of this title] to improve the force management and
readiness of the Commissioned Corps to accomplish the
following objectives:
‘‘(1) To ensure the Corps is ready to respond rapidly
to urgent or emergency public health care needs and
challenges.
‘‘(2) To ensure the availability of the Corps for assignments that address clinical and public health
needs in isolated, hardship, and hazardous duty positions, and, when required, to address needs related to
the well-being, security, and defense of the United
States.
‘‘(3) To establish the Corps as a resource available
to Federal and State Government agencies for assistance in meeting public health leadership and service
roles.’’

§ 205. Appointment and tenure of office of Surgeon General; reversion in rank
The Surgeon General shall be appointed from
the Regular Corps for a four-year term by the
President by and with the advice and consent of
the Senate. The Surgeon General shall be appointed from individuals who (1) are members of
the Regular Corps, and (2) have specialized
training or significant experience in public
health programs. Upon the expiration of such
term the Surgeon General, unless reappointed,
shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he not served as Surgeon General.
(July 1, 1944, ch. 373, title II, § 204, 58 Stat. 684;
Pub. L. 97–25, title III, § 303(a), July 27, 1981, 95
Stat. 145; Pub. L. 97–35, title XXVII, § 2765(b),
Aug. 13, 1981, 95 Stat. 932.)
AMENDMENTS
1981—Pub. L. 97–35 inserted reference to Reserve
Corps and substituted provisions relating to appointment of an individual from the Regular Corps and with
specialized training and significant experience, for provisions relating to appointment of an individual sixtyfour years of age or older.
Pub. L. 97–25 inserted provision that the President
may appoint to office of Surgeon General an individual
who is sixty-four years of age or older.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 206

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 206. Assignment of officers
(a) Deputy Surgeon General
The Surgeon General shall assign one commissioned officer from the Regular Corps to administer the Office of the Surgeon General, to act as
Surgeon General during the absence or disability of the Surgeon General or in the event of a
vacancy in that office, and to perform such
other duties as the Surgeon General may prescribe, and while so assigned he shall have the
title of Deputy Surgeon General.
(b) Assistant Surgeons General
The Surgeon General shall assign eight commissioned officers from the Regular Corps to be,
respectively, the Director of the National Institutes of Health, the Chief of the Bureau of State
Services, the Chief of the Bureau of Medical
Services, the Chief Medical Officer of the United
States Coast Guard, the Chief Dental Officer of
the Service, the Chief Nurse Officer of the Service, the Chief Pharmacist Officer of the Service,
and the Chief Sanitary Engineering Officer of
the Service, and while so serving they shall each
have the title of Assistant Surgeon General.
(c) Creation of temporary positions as Assistant
Surgeons General
(1) The Surgeon General, with the approval of
the Secretary, is authorized to create special
temporary positions in the grade of Assistant
Surgeons General when necessary for the proper
staffing of the Service. The Surgeon General
may assign officers of either the Regular Corps
or the Reserve Corps to any such temporary position, and while so serving they shall each have
the title of Assistant Surgeon General.
(2) Except as provided in this paragraph, the
number of special temporary positions created
by the Surgeon General under paragraph (1)
shall not on any day exceed 1 per centum of the
highest number, during the ninety days preceding such day, of officers of the Regular Corps on
active duty and officers of the Reserve Corps on
active duty for more than thirty days. If on any
day the number of such special temporary positions exceeds such 1 per centum limitation, for
a period of not more than one year after such
day, the number of such special temporary positions shall be reduced for purposes of complying
with such 1 per centum limitation only by the
resignation, retirement, death, or transfer to a
position of a lower grade, of any officer holding
any such temporary position.
(d) Designation of Assistant Surgeon General
with respect to absence, disability, or vacancy in offices of Surgeon General and Deputy Surgeon General
The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in case of absence or disability, or
vacancy in the offices, of both the Surgeon General and the Deputy Surgeon General.
(July 1, 1944, ch. 373, title II, § 205, 58 Stat. 684;
Feb. 28, 1948, ch. 83, § 3, 62 Stat. 39; June 16, 1948,
ch. 481, § 6(b), 62 Stat. 469; 1953 Reorg. Plan No.
1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat.
631; Pub. L. 96–76, title III, §§ 302(b), 303, Sept. 29,
1979, 93 Stat. 584.)

Page 54

AMENDMENTS
1979—Subsec. (b). Pub. L. 96–76, § 302(b), inserted provisions relating to assignment of Chief Nurse Officer
and Chief Pharmacist Officer, and substituted ‘‘eight’’
for ‘‘six’’.
Subsec. (c). Pub. L. 96–76, § 303, designated existing
provisions as par. (1), struck out provisions relating to
maximum number of special temporary positions, and
added par. (2).
1948—Subsec. (b). Act June 16, 1948, substituted ‘‘National Institutes of Health’’ for ‘‘National Institute of
Health’’.
Subsecs. (c), (d). Act Feb. 28, 1948, added subsec. (c)
and redesignated former subsec. (c) as (d).
EFFECTIVE DATE OF 1979 AMENDMENT
Section 314 of Pub. L. 96–76 provided that: ‘‘The
amendments made by sections 303, 304, 305, 306, 307, and
313 [amending this section, sections 207, 209, 210b, and
211 of this title, and sections 201, 415, and 1006 of Title
37, Pay and Allowances of the Uniformed Services]
shall take effect on October 1, 1979.’’
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Office of Surgeon General, together with office held
by Deputy Surgeon General, Bureau of Medical Services, including office of Chief of Bureau of Medical
Services, Bureau of State Services, including office of
Chief of Bureau of State Services, and National Institutes of Health, including office of Director of National
Institutes of Health, abolished by section 3 of Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, and functions thereof transferred to Secretary of
Health, Education, and Welfare by section 1 of Reorg.
Plan No. 3 of 1966, set out as a note under section 202
of this title. Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified
to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare, by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 207. Grades, ranks, and titles of commissioned
corps
(a) Grades of commissioned officers
The Surgeon General, during the period of his
appointment as such, shall be of the same grade
as the Surgeon General of the Army; the Deputy
Surgeon General and the Chief Medical Officer
of the United States Coast Guard, while assigned
as such, shall have the grade corresponding with
the grade of major general; and the Chief Dental
Officer, while assigned as such, shall have the
grade as is prescribed by law for the officer of
the Dental Corps selected and appointed as Assistant Surgeon General of the Army. During
the period of appointment to the position of As-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

sistant Secretary for Health, a commissioned officer of the Public Health Service shall have the
grade corresponding to the grade of General of
the Army. Assistant Surgeons General, while assigned as such, shall have the grade corresponding with either the grade of brigadier general or
the grade of major general, as may be determined by the Secretary after considering the
importance of the duties to be performed: Provided, That the number of Assistant Surgeons
General having a grade higher than that corresponding to the grade of brigadier general
shall at no time exceed one-half of the number
of positions created by subsection (b) of section
206 of this title or pursuant to subsection (c) of
section 206 of this title. The grades of commissioned officers of the Service shall correspond
with grades of officers of the Army as follows:
(1) Officers of the director grade—colonel;
(2) Officers of the senior grade—lieutenant
colonel;
(3) Officers of the full grade—major;
(4) Officers of the senior assistant grade—
captain;
(5) Officers of the assistant grade—first lieutenant;
(6) Officers of the junior assistant grade—
second lieutenant;
(7) Chief warrant officers of (W–4) grade—
chief warrant officer (W–4);
(8) Chief warrant officers of (W–3) grade—
chief warrant officer (W–3);
(9) Chief warrant officers of (W–2) grade—
chief warrant officer (W–2); and
(10) Warrant officers of (W–1) grade—warrant
officer (W–1).
(b) Titles of medical officers
The titles of medical officers of the foregoing
grades shall be respectively (1) medical director,
(2) senior surgeon, (3) surgeon, (4) senior assistant surgeon, (5) assistant surgeon, and (6) junior
assistant surgeon. The President is authorized
to prescribe titles, appropriate to the several
grades, for commissioned officers of the Service
other than medical officers. All titles of the officers of the Reserve Corps shall have the suffix
‘‘Reserve’’.
(c) Repealed. Pub. L. 96–76, title III, § 304(b),
Sept. 29, 1979, 93 Stat. 584
(d) Maximum number in grade for each fiscal
year
Within the total number of officers of the Regular Corps authorized by the appropriation Act
or Acts for each fiscal year to be on active duty,
the Secretary shall by regulation prescribe the
maximum number of officers authorized to be in
each of the grades from the warrant officer
(W–1) grade to the director grade, inclusive.
Such numbers shall be determined after considering the anticipated needs of the Service during
the fiscal year, the funds available, the number
of officers in each grade at the beginning of the
fiscal year, and the anticipated appointments,
the anticipated promotions based on years of
service, and the anticipated retirements during
the fiscal year. The number so determined for
any grade for a fiscal year may not exceed the
number limitation (if any) contained in the appropriation Act or Acts for such year. Such reg-

§ 207

ulations for each fiscal year shall be prescribed
as promptly as possible after the appropriation
Act fixing the authorized strength of the corps
for that year, and shall be subject to amendment only if such authorized strength or such
number limitation is thereafter changed. The
maxima established by such regulations shall
not require (apart from action pursuant to other
provisions of this chapter) any officer to be separated from the Service or reduced in grade.
(e) Exception to grade limitations for officers assigned to Department of Defense
In computing the maximum number of commissioned officers of the Public Health Service
authorized by law to hold a grade which corresponds to the grade of brigadier general or
major general, there may be excluded from such
computation not more than three officers who
hold such a grade so long as such officers are assigned to duty and are serving in a policymaking position in the Department of Defense.
(f) Exception to maximum number limitations for
officers assigned to Department of Defense
In computing the maximum number of commissioned officers of the Public Health Service
authorized by law or administrative determination to serve on active duty, there may be excluded from such computation officers who are
assigned to duty in the Department of Defense.
(July 1, 1944, ch. 373, title II, § 206, 58 Stat. 684;
Feb. 28, 1948, ch. 83, § 4, 62 Stat. 39; Oct. 31, 1951,
ch. 653, 65 Stat. 700; July 17, 1952, ch. 931, 66 Stat.
758; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 87–649,
§ 11(1), Sept. 7, 1962, 76 Stat. 497; Pub. L. 95–215,
§ 8(b), Dec. 19, 1977, 91 Stat. 1507; Pub. L. 96–76,
title III, § 304, Sept. 29, 1979, 93 Stat. 584; Pub. L.
99–117, § 9, Oct. 7, 1985, 99 Stat. 494; Pub. L. 101–93,
§ 5(p), Aug. 16, 1989, 103 Stat. 614; Pub. L. 101–502,
§ 5(k)(1), Nov. 3, 1990, 104 Stat. 1289; Pub. L.
104–201, div. A, title V, § 582, Sept. 23, 1996, 110
Stat. 2538.)
AMENDMENTS
1996—Subsec. (f). Pub. L. 104–201 added subsec. (f).
1990—Subsec. (a). Pub. L. 101–502 inserted after first
sentence ‘‘During the period of appointment to the position of Assistant Secretary for Health, a commissioned officer of the Public Health Service shall have
the grade corresponding to the grade of General of the
Army.’’
1989—Subsec. (e). Pub. L. 101–93, which directed the
substitution of ‘‘the Department of Defense’’ for ‘‘the
office of Assistant Secretary of Defense for Health Affairs’’, was executed by making the substitution for
‘‘the office of the Assistant Secretary of Defense for
Health Affairs’’ as the probable intent of Congress.
1985—Subsec. (e). Pub. L. 99–117 added subsec. (e).
1979—Subsec. (a). Pub. L. 96–76, § 304(a), added pars. (7)
to (10).
Subsec. (c). Pub. L. 96–76, § 304(b), struck out subsec.
(c) setting forth the grade and pay and allowances as
director for a commissioned officer below the grade of
director assigned to serve as chief of a division.
Subsec. (d). Pub. L. 96–76, § 304(c), substituted ‘‘warrant officer (W–1)’’ for ‘‘junior assistant’’.
1977—Subsec. (b)(6). Pub. L. 95–215 substituted ‘‘junior
assistant’’ for ‘‘senior assistant’’.
1962—Subsec. (a). Pub. L. 87–649 struck out provisions
which related to pay and allowances.
1952—Subsec. (a). Act July 17, 1952, provided that the
Chief Medical Officer of the Coast Guard should have
the grade, pay, and allowances of a major general.

§ 208

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1951—Subsec. (a). Act Oct. 31, 1951, provided equality
of grade, pay, and allowances between the Chief Dental
Officer and the comparable officer in the Army.
1948—Subsec. (a). Act Feb. 28, 1948, increased grade of
Deputy Surgeon General from brigadier general to
major general and increased grade of certain Assistant
Surgeons General from brigadier general to major general as the Federal Security Administrator might determine.
Subsecs. (c), (d). Act Feb. 28, 1948, added subsecs. (c)
and (d).
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–502 effective Dec. 1, 1990,
see section 5(k)(3) of Pub. L. 101–502, set out as a note
under section 201 of Title 37, Pay and Allowances of the
Uniformed Services.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–76 effective Oct. 1, 1979, see
section 314 of Pub. L. 96–76, set out as a note under section 206 of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87–649 effective Nov. 1, 1962,
see section 15 of Pub. L. 87–649, set out as an Effective
Date note preceding section 101 of Title 37, Pay and Allowances of the Uniformed Services.
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Office of Surgeon General, together with office held
by Deputy Surgeon General, abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.
30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§ 208. Repealed. Feb. 28, 1948, ch. 83, § 5(a), 62
Stat. 40
Section, act July 1, 1944, ch. 373, title II, § 207, 58 Stat.
685, related to establishment of special temporary provisions. See sections 206(c) and 207(c) of this title.

Page 56

§ 209. Appointment of personnel
(a) Original appointments to Regular and Reserve Corps; limitation on appointment and
call to active duty
(1) Except as provided in subsections (b) and
(e) of this section, original appointments to the
Regular Corps may be made only in the warrant
officer (W–1), chief warrant officer (W–2), chief
warrant officer (W–3), chief warrant officer
(W–4), junior assistant, assistant, and senior assistant grades and original appointments to a
grade above junior assistant shall be made only
after passage of an examination, given in accordance with regulations of the President, in
one or more of the several branches of medicine,
dentistry, hygiene, sanitary engineering, pharmacy, psychology, nursing, or related scientific
specialties in the field of public health.
(2) Original appointments to the Reserve Corps
may be made to any grade up to and including
the director grade but only after passage of an
examination given in accordance with regulations of the President. Reserve commissions
shall be for an indefinite period and may be terminated at any time, as the President may direct.
(3) No individual who has attained the age of
forty-four shall be appointed to the Regular
Corps, or called to active duty in the Reserve
Corps for a period in excess of one year, unless
(A) he has had a number of years of active service (as defined in section 212(d) of this title)
equal to the number of years by which his age
exceeds forty-four, or (B) the Surgeon General
determines that he possesses exceptional qualifications, not readily available elsewhere in the
Commissioned Corps of the Public Health Service, for the performance of special duties with
the Service, or (C) in the case of an officer of the
Reserve Corps, the Commissioned Corps of the
Service has been declared by the President to be
a military service.
(b) Grade and number of original appointments
(1) Not more than 10 per centum of the original appointments to the Regular Corps authorized to be made during any fiscal year may be
made to grades above that of senior assistant,
but no such appointment (other than an appointment under section 205 of this title) may be
made to a grade above that of director. For the
purpose of this subsection the number of original appointments authorized to be made during
a fiscal year shall be (1) the excess of the number of officers of the Regular Corps authorized
by the appropriation Act or Acts for such year
over the number of officers on active duty in the
Regular Corps on the first day of such year, plus
(2) the number of such officers of the Regular
Corps who, during such fiscal year, have been or
will be retired upon attainment of age sixty-four
or have for any other reason ceased to be on active duty. In determining the number of appointments authorized by this subsection an appointment shall be deemed to be made in the fiscal year in which the nomination is transmitted
by the President to the Senate.
(2) In addition to the number of original appointments to the Regular Corps authorized by
paragraph (1) to be made to grades above that of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

senior assistant, original appointments authorized to be made to the Regular Corps in any year
may be made to grades above that of senior assistant, but not above that of director, in the
case of any individual who—
(A)(i) was on active duty in the Reserve
Corps on July 1, 1960, (ii) was on such active
duty continuously for not less than one year
immediately prior to such date, and (iii) applies for appointment to the Regular Corps
prior to July 1, 1962; or
(B) does not come within clause (A)(i) and
(ii) but was on active duty in the Reserve
Corps continuously for not less than one year
immediately prior to his appointment to the
Regular Corps and has not served on active
duty continuously for a period, occurring after
June 30, 1960, of more than three and one-half
years prior to applying for such appointment.
(3) No person shall be appointed pursuant to
this subsection unless he meets standards established in accordance with regulations of the
President.
(c) Issuance of commissions
Commissions evidencing the appointment by
the President of officers of the Regular or Reserve Corps shall be issued by the Secretary
under the seal of the Department of Health and
Human Services.
(d) Date of appointment; credit for service
(1) For purposes of basic pay and for purposes
of promotion, any person appointed under subsection (a) of this section to the grade of senior
assistant in the Regular Corps, and any person
appointed under subsection (b) of this section,
shall, except as provided in paragraphs (2) and
(3) of this subsection, be considered as having
had on the date of appointment the following
length of service: Three years if appointed to the
senior assistant grade, ten years if appointed to
the full grade, seventeen years if appointed to
the senior grade, and eighteen years if appointed
to the director grade.
(2) For purposes of basic pay, any person appointed under subsection (a) of this section to
the grade of senior assistant in the Regular
Corps, and any person appointed under subsection (b) of this section, shall, in lieu of the
credit provided in paragraph (1) of this subsection, be credited with the service for which
he is entitled to credit under any other provision of law if such service exceeds that to which
he would be entitled under such paragraph.
(3) For purposes of promotion, any person
originally appointed in the Regular Corps to the
senior assistant grade or above who has had active service in the Reserve Corps shall be considered as having had on the date of appointment
the length of service provided for in paragraph
(1) of this subsection, plus whichever of the following is greater: (A) The excess of his total active service in the Reserve Corps (above the
grade of junior assistant) over the length of
service provided in such paragraph, to the extent that such excess is on account of service in
the Reserve Corps in or above the grade to which
he is appointed in the Regular Corps or (B) his
active service in the same or any higher grade in
the Reserve Corps after the first day on which,

§ 209

under regulations in effect on the date of his appointment to the Regular Corps, he would have
had the training and experience necessary for
such appointment.
(4) For purposes of promotion, any person
whose original appointment is to the assistant
grade in the Regular Corps shall be considered
as having had on the date of appointment service equal to his total active service in the Reserve Corps in and above the assistant grade.
(e) Reappointment; credit for service
(1) A former officer of the Regular Corps may,
if application for appointment is made within
two years after the date of the termination of
his prior commission in the Regular Corps, be
reappointed to the Regular Corps without examination, except as the Surgeon General may
otherwise prescribe, and without regard to the
numerical limitations of subsection (b) of this
section.
(2) Reappointments pursuant to this subsection may be made to the permanent grade
held by the former officer at the time of the termination of his prior commission, or to the next
higher grade if such officer meets the eligibility
requirements prescribed by regulation for original appointment to such higher grade. For purposes of pay, promotion, and seniority in grade,
such reappointed officer shall receive the credits
for service to which he would be entitled if such
appointment were an original appointment, but
in no event less than the credits he held at the
time his prior commission was terminated, except that if such officer is reappointed to the
next higher grade he shall receive no credit for
seniority in grade.
(3) No former officer shall be reappointed pursuant to this subsection unless he shall meet
such standards as the Secretary may prescribe.
(f) Special consultants
In accordance with regulations, special consultants may be employed to assist and advise
in the operations of the Service. Such consultants may be appointed without regard to the
civil-service laws.
(g) Designation for fellowships; duties; pay
In accordance with regulations, individual scientists, other than commissioned officers of the
Service, may be designated by the Surgeon General to receive fellowships, appointed for duty
with the Service without regard to the civilservice laws, may hold their fellowships under
conditions prescribed therein, and may be assigned for studies or investigations either in
this country or abroad during the terms of their
fellowships.
(h) Aliens
Persons who are not citizens may be employed
as consultants pursuant to subsection (f) of this
section and may be appointed to fellowships pursuant to subsection (g) of this section. Unless
otherwise specifically provided, any prohibition
in any other Act against the employment of
aliens, or against the payment of compensation
to them, shall not be applicable in the case of
persons employed or appointed pursuant to such
subsections.
(i) Civil service appointments by Secretary
The appointment of any officer or employee of
the Service made in accordance with the civil-

§ 209

TITLE 42—THE PUBLIC HEALTH AND WELFARE

service laws shall be made by the Secretary, and
may be made effective as of the date on which
such officer or employee enters upon duty.
(July 1, 1944, ch. 373, title II, § 207, formerly § 208,
58 Stat. 685; July 3, 1946, ch. 538, § 4, 60 Stat. 421;
Aug. 13, 1946, ch. 958, § 3, 60 Stat. 1049; renumbered § 207 and amended Feb. 28, 1948, ch. 83,
§ 5(a)–(d), 62 Stat. 40; Oct. 12, 1949, ch. 681, title V,
§ 521(a), 63 Stat. 834; 1953 Reorg. Plan No. 1, §§ 5,
8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Apr.
27, 1956, ch. 211, § 3(a)–(c)(1), 70 Stat. 116; Pub. L.
86–415, §§ 2, 3, Apr. 8, 1960, 74 Stat. 32; Pub. L.
96–76, title III, § 305, Sept. 29, 1979, 93 Stat. 585;
Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695; Pub. L. 97–35, title XXVII, § 2765(c),
Aug. 13, 1981, 95 Stat. 933; Pub. L. 97–414, § 8(a),
Jan. 4, 1983, 96 Stat. 2060.)
CODIFICATION
In subsec. (f), the words ‘‘and their compensation
may be fixed without regard to the Classification Act
of 1923, as amended’’, and in subsec. (g), the words ‘‘and
compensated without regard to the Classification Act
of 1923, as amended’’ were omitted as obsolete. Sections
1202 and 1204 of the Classification Act of 1949, 63 Stat.
972, 973, repealed the 1923 Act and all laws or parts of
laws inconsistent with the 1949 Act. While section
1106(a) of the 1949 Act provided that references in other
laws to the 1923 Act should be held and considered to
mean the 1949 Act, it did not have the effect of continuing the exceptions contained in subsecs. (f) and (g) because of section 1106(b) which provided that the application of the 1949 Act to any position, officer, or employee shall not be affected by section 1106(a). The
Classification Act of 1949 was repealed by Pub. L.
89–554, Sept. 6, 1966, § 8(a), 80 Stat. 632 (of which section
1 revised and enacted Title 5, Government Organization
and Employees, into law). Section 5102 of Title 5 contains the applicability provisions of the 1949 Act, and
section 5103 of Title 5 authorizes the Office of Personnel
Management to determine the applicability to specific
positions and employees.
In subsec. (h), the references to subsections (f) and (g)
of this section were, in the original, references to subsections (e) and (f) and were changed to reflect the
probable intent of Congress.
PRIOR PROVISIONS
A prior section 207 of act July 1, 1944, was classified
to section 208 of this title, prior to repeal by act Feb.
28, 1948, ch. 83, § 5(a), 62 Stat. 40.
AMENDMENTS
1983—Subsec. (a)(1). Pub. L. 97–414 inserted ‘‘psychology,’’ after ‘‘pharmacy,’’.
1981—Subsec. (b)(1). Pub. L. 97–35 inserted provisions
relating to exception for an appointment under section
205 of this title.
1979—Subsec. (a)(1). Pub. L. 96–76 inserted applicability to warrant officers and chief warrant officers.
1960—Subsec. (a)(3). Pub. L. 86–415, § 2, added par. (3).
Subsec. (b). Pub. L. 86–415, § 3, designated first, second
and third sentences as par. (1), fourth sentence as par.
(3), and added par. (2).
1956—Subsec. (a)(1). Act Apr. 27, 1956, § 3(a), inserted
reference to subsection (e) of this section.
Subsec. (a)(2). Act Apr. 27, 1956, § 3(c)(1), substituted
‘‘an indefinite period’’ for ‘‘a period of not more than
five years’’.
Subsecs. (e) to (i). Act Apr. 27, 1956, § 3(b), added subsec. (e) and redesignated former subsecs. (e) to (h) as (f)
to (i), respectively.
1949—Subsec. (d). Act Oct. 12, 1949, substituted ‘‘base
pay’’ for ‘‘pay and pay period’’ wherever appearing.
1948—Subsec. (a)(1). Act Feb. 28, 1948, struck out ‘‘surgery’’ after ‘‘several branches of medicine’’.

Page 58

Subsec. (a)(2). Act Feb. 28, 1948, struck out ‘‘any such
commission’’ before ‘‘may be terminated’’, and ‘‘in his
discretion’’ after ‘‘at any time’’.
Subsec. (b). Act Feb. 28, 1948, provided for grade and
number of original appointments.
Subsecs. (c) to (f). Act Feb. 28, 1948, added subsecs. (c)
and (d) and redesignated former subsecs. (c) and (d) as
(e) and (f), respectively. Former subsecs. (e) and (f) redesignated (g) and (h).
Subsec. (g). Act Feb. 28, 1948, redesignated former
subsec. (e) as (g) and changed reference in text from
‘‘subsection (c) of this section’’ to ‘‘subsection (e) of
this section’’, and ‘‘subsection (d) of this section’’ to
‘‘subsection (g) of this section’’.
Subsec. (h). Act Feb. 28, 1948, redesignated former
subsec. (f) as (h).
1946—Subsec. (b). Act July 3, 1946, authorized appointment of additional officers to grades above that of senior assistant but not above that of director, and limits
the number so appointed to 20.
Subsec. (b)(2). Act Aug. 13, 1946, inserted ‘‘(A)’’ before
‘‘to assist’’, substituted ‘‘clause’’ for ‘‘paragraphs’’, and
inserted cl. (B).
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–76 effective Oct. 1, 1979, see
section 314 of Pub. L. 96–76, set out as a note under section 206 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Section 8(a) of Pub. L. 86–415 provided that: ‘‘The
amendments made by sections 2 and 5(b) [amending
this section and section 210 of this title] shall become
effective July 1, 1960.’’
EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services and Surgeon General, see
Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under section 202 of this title.
PERSONAL SERVICES CONTRACTING
Pub. L. 109–149, title II, § 216, Dec. 30, 2005, 119 Stat.
2861, provided that: ‘‘The Division of Federal Occupational Health hereafter may utilize personal services
contracting to employ professional management/administrative and occupational health professionals.’’

Page 59

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 210

SIMILAR PROVISIONS

CODIFICATION

Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 108–447, div. F, title II, § 216, Dec. 8, 2004, 118
Stat. 3141.
Pub. L. 108–199, div. E, title II, § 216, Jan. 23, 2004, 118
Stat. 255.
Pub. L. 108–7, div. G, title II, § 216, Feb. 20, 2003, 117
Stat. 325.
Pub. L. 107–116, title II, § 216, Jan. 10, 2002, 115 Stat.
2201.
Pub. L. 106–554, § 1(a)(1) [title II], Dec. 21, 2000, 114
Stat. 2763, 2763A–13.
Pub. L. 106–113, div. B, § 1000(a)(4) [title II], Nov. 29,
1999, 113 Stat. 1535, 1501A–225.
Pub. L. 105–277, div. A, § 101(f) [title II], Oct. 21, 1998,
112 Stat. 2681–337, 2681–347.
Pub. L. 105–78, title II, Nov. 13, 1997, 111 Stat. 1477.
Pub. L. 104–208, div. A, title I, § 101(e) [title II], Sept.
30, 1996, 110 Stat. 3009–233, 3009–242.
Pub. L. 104–134, title I, § 101(d) [title II], Apr. 26, 1996,
110 Stat. 1321–211, 1321–221; renumbered title I, Pub. L.
104–140, § 1(a), May 2, 1996, 110 Stat. 1327.

Section was not enacted as a part of the Public
Health Service Act which comprises this chapter.

TERM OF RESERVE COMMISSIONS IN EFFECT ON
APRIL 27, 1956
Act Apr. 27, 1956, ch. 211, § 3(c)(2), 70 Stat. 117, provided that: ‘‘The enactment of paragraph (1) of this
subsection [amending this section] shall not affect the
term of the commission of any officer in the Reserve
Corps in effect on the date of such enactment [Apr. 27,
1956] unless such officer consents in writing to the extension of his commission for an indefinite period, in
which event his commission shall be so extended without the necessity of a new appointment.’’

§§ 209a, 209b. Omitted
CODIFICATION
Section 209a, act Dec. 22, 1944, ch. 660, title I, 58 Stat.
856, which related to number of regular commissioned
nurses to be appointed, their grades, and their length of
service for purposes of pay and pay periods, was not repeated in subsequent appropriation acts.
Section 209b, act Dec. 22, 1944, ch. 660, title I, 58 Stat.
857, which authorized appointment of fifty additional
regular commissioned officers of which twenty-four
were to be in grades above that of senior assistant, was
not repeated in subsequent appropriation acts.

§ 209c. Repealed. Pub. L. 87–649, § 14b, Sept. 7,
1962, 76 Stat. 499
Section, act July 3, 1945, ch. 263, title II, 59 Stat. 370,
provided that for purposes of pay and pay period officers appointed to grades above that of senior assistant
pursuant to section 209b of this title shall be considered
as having had on date of appointment service equal to
that of junior officer of grade to which appointed.

§ 209d. Appointment of osteopaths as commissioned officers
Graduates of colleges of osteopathy whose
graduates are eligible for licensure to practice
medicine or osteopathy in a majority of the
States of the United States, or approved by a
body or bodies acceptable to the Secretary, shall
be eligible, subject to the other provisions of
this Act, for appointment as commissioned medical officers in the Public Health Service.
(Feb. 28, 1948, ch. 83, § 5(b), 62 Stat. 40; 1953 Reorg.
Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631.)
REFERENCES IN TEXT
This Act, referred to in text, is act Feb. 28, 1948, ch.
83, 62 Stat. 38. For complete classification of this Act
to the Code, see Tables.

TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 210. Pay and allowances
(a) Commissioned officers of Regular and Reserve Corps; special pay for active duty; incentive special pay for Public Health Service
nurses
(1) Commissioned officers of the Regular and
Reserve Corps shall be entitled to receive such
pay and allowances as are now or may hereafter
be authorized by law.
(2) For provisions relating to the receipt of
special pay by commissioned officers of the Regular and Reserve Corps while on active duty, see
section 303a(b) of title 37.
(b) Purchase of supplies
Commissioned officers on active duty and retired officers entitled to retired pay pursuant to
section 211(g)(3), 212, or 213a(a) of this title, shall
be permitted to purchase supplies from the
Army, Navy, Air Force, and Marine Corps at the
same price as is charged officers thereof.
(c) Members of national advisory or review councils or committees
Members of the National Advisory Health
Council and members of other national advisory
or review councils or committees established
under this chapter, including members of the
Technical Electronic Product Radiation Safety
Standards Committee and the Board of Regents
of the National Library of Medicine, but excluding ex officio members, while attending conferences or meetings of their respective councils
or committees or while otherwise serving at the
request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the
Secretary, but at rates not exceeding the daily
equivalent of the rate specified at the time of
such service for grade GS–18 of the General
Schedule, including traveltime; and while away
from their homes or regular places of business
they may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by
section 5703 of title 5 for persons in the Government service employed intermittently.

§ 210

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Field employees
Field employees of the Service, except those
employed on a per diem or fee basis, who render
part-time duty and are also subject to call at
any time for services not contemplated in their
regular part-time employment, may be paid annual compensation for such part-time duty and,
in addition, such fees for such other services as
the Surgeon General may determine; but in no
case shall the total paid to any such employee
for any fiscal year exceed the amount of the
minimum annual salary rate of the classification grade of the employee.
(e) Additional pay for service at Gillis W. Long
Hansen’s Disease Center
Any civilian employee of the Service who is
employed at the Gillis W. Long Hansen’s Disease
Center on April 7, 1986, shall be entitled to receive, in addition to any compensation to which
the employee may otherwise be entitled and for
so long as the employee remains employed at
the Center, an amount equal to one-fourth of
such compensation.
(f) Allowances included in fellowships
Individuals appointed under section 209(g) of
this title shall have included in their fellowships
such stipends or allowances, including travel
and subsistence expenses, as the Surgeon General may deem necessary to procure qualified
fellows.
(g) Positions in professional, scientific and executive service; compensation; appointment
The Secretary is authorized to establish and
fix the compensation for, within the Public
Health Service, not more than one hundred and
seventy-nine positions, of which not less than
one hundred and fifteen shall be for the National
Institutes of Health, not less than five shall be
for the National Institute on Alcohol Abuse and
Alcoholism for individuals engaged in research
on alcohol abuse and alcoholism, not less than
ten shall be for the National Center for Health
Services Research, not less than twelve shall be
for the National Center for Health Statistics,
and not less than seven shall be for the National
Center for Health Care Technology, in the professional, scientific, and executive service, each
such position being established to effectuate
those research and development activities of the
Public Health Service which require the services
of specially qualified scientific, professional and
administrative personnel: Provided, That the
rates of compensation for positions established
pursuant to the provisions of this subsection
shall not be less than the minimum rate of
grade 16 of the General Schedule nor more than
(1) the highest rate of grade 18 of the General
Schedule, or (2) in the case of two such positions, the rate specified, at the time the service
in the position is performed, for level II of the
Executive Schedule (5 U.S.C. 5313); and such
rates of compensation for all positions included
in this proviso shall be subject to the approval
of the Director of the Office of Personnel Management. Positions created pursuant to this subsection shall be included in the classified civil
service of the United States, but appointments
to such positions shall be made without competitive examination upon approval of the pro-

Page 60

posed appointee’s qualifications by the Director
of the Office of Personnel Management or such
officers or agents as it may designate for this
purpose.
(July 1, 1944, ch. 373, title II, § 208, formerly § 209,
58 Stat. 686; July 3, 1946, ch. 538, § 5(a), 60 Stat.
422; renumbered § 208 and amended Feb. 28, 1948,
ch. 83, § 5(a), (g), (h), 62 Stat. 40; June 16, 1948, ch.
481, § 4(d), 62 Stat. 467; June 24, 1948, ch. 621,
§ 4(d), 62 Stat. 601; Oct. 12, 1949, ch. 681, title V,
§ 521(b), 63 Stat. 834; Aug. 9, 1950, ch. 654, § 1, 64
Stat. 426; Aug. 15, 1950, ch. 714, §§ 3(e), 4(b), 64
Stat. 447; 1953 Reorg. Plan No. 1, §§ 5, 8 eff. Apr.
11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 1, 1955, ch.
437, title II, § 201, 69 Stat. 407; June 29, 1956, ch.
477, title II, § 201, 70 Stat. 430; July 31, 1956, ch.
804, title I, § 117(b), 70 Stat. 741; Pub. L. 85–462,
§ 12(e), June 20, 1958, 72 Stat. 214; Pub. L. 85–929,
§ 9, Sept. 6, 1958, 72 Stat. 1789; Pub. L. 86–415,
§ 5(b), Apr. 8, 1960, 74 Stat. 34; Pub. L. 86–703, title
II, § 201, Sept. 2, 1960, 74 Stat. 764; Pub. L. 87–649,
§§ 11(3), 14b, Sept. 7, 1962, 76 Stat. 497, 499; Pub. L.
87–793, § 1001(d), Oct. 11, 1962, 76 Stat. 864; Pub. L.
88–426, title III, § 305(1), Aug. 14, 1964, 78 Stat. 422;
Pub. L. 90–574, title V, § 501, Oct. 15, 1968, 82 Stat.
1012; Pub. L. 91–515, title VI, § 601(b)(1), Oct. 30,
1970, 84 Stat. 1310; Pub. L. 92–157, title III,
§ 301(a), Nov. 18, 1971, 85 Stat. 463; Pub. L. 95–83,
title III, § 312, Aug. 1, 1977, 91 Stat. 398; Pub. L.
95–623, § 11(a), Nov. 9, 1978, 92 Stat. 3455; 1978
Reorg. Plan No. 2, § 102, eff. Jan. 1, 1979, 43 F.R.
36037, 92 Stat. 3783; Pub. L. 96–32, § 7(g), July 10,
1979, 93 Stat. 84; Pub. L. 96–398, title VIII, § 805,
Oct. 7, 1980, 94 Stat. 1608; Pub. L. 99–117, § 3(a),
Oct. 7, 1985, 99 Stat. 491; Pub. L. 99–272, title
XVII, § 17002(a)(1), (b), Apr. 7, 1986, 100 Stat. 359;
Pub. L. 100–607, title VII, § 706, Nov. 4, 1988, 102
Stat. 3159; Pub. L. 106–398, § 1 [[div. A], title VI,
§ 634(b)], Oct. 30, 2000, 114 Stat. 1654, 1654A–159.)
REFERENCES IN TEXT
Classified civil service, referred to in subsec. (g), as
meaning ‘‘competitive service’’, see section 2102(c) of
Title 5, Government Organization and Employees.
PRIOR PROVISIONS
A prior section 208 of act July 1, 1944, was renumbered
section 207 and is classified to section 209 of this title.
AMENDMENTS
2000—Subsec. (a)(2). Pub. L. 106–398 added par. (2) and
struck out former par. (2) which read as follows:
‘‘(2)(A) Except as provided in subparagraph (B), commissioned medical and dental officers in the Regular
and Reserve Corps shall while on active duty be paid
special pay in the same amounts as, and under the
same terms and conditions which apply to, the special
pay now or hereafter paid to commissioned medical and
dental officers of the Armed Forces under chapter 5 of
title 37.
‘‘(B) A commissioned medical officer in the Regular
or Reserve Corps (other than an officer serving in the
Indian Health Service) may not receive additional special pay under section 302(a)(4) of title 37 for any period
during which the officer is providing obligated service
under (i) section 254m of this title, (ii) section 234(e) of
this title (as such section was in effect prior to October
1, 1977), or (iii) section 294u of this title (as such section
was in effect between October 1, 1977, and August 13,
1981).’’
Subsec. (a)(3). Pub. L. 106–398, § 1 [[div. A], title VI,
§ 634(b)(1)], struck out par. (3) which read as follows:
‘‘Commissioned nurse officers in the Regular and Reserve Corps shall, while in active duty, be paid incen-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tive special pay in the same amounts as, and under the
same terms and conditions which apply to, the incentive special pay now or hereafter paid to commissioned
nurse officers of the Armed Forces under chapter 5 of
title 37.’’
1988—Subsec. (a)(3). Pub. L. 100–607 added par. (3).
1986—Subsec. (a)(2)(B). Pub. L. 99–272, § 17002(a)(1), inserted ‘‘(other than an officer serving in the Indian
Health Service)’’.
Subsec. (e). Pub. L. 99–272, § 17002(b), amended subsec.
(e) generally. Prior to amendment, subsec. (e) read as
follows: ‘‘Whenever any noncommissioned officer or
other employee of the Service is assigned for duty
which the Surgeon General finds requires intimate contact with persons afflicted with leprosy, he may be entitled to receive, as provided by regulations of the
President, in addition to any pay or compensation to
which he may otherwise be entitled, not more than
one-half of such pay or compensation.’’
1985—Subsec. (a)(2). Pub. L. 99–117 substituted ‘‘(A)
Except as provided in subparagraph (B), commissioned’’
for ‘‘Commissioned’’, and added subpar. (B).
1980—Subsec. (a). Pub. L. 96–398 redesignated existing
provisions as par. (1) and added par. (2).
1979—Subsec. (c). Pub. L. 96–32 substituted ‘‘section
5703 of title 5’’ for ‘‘section 5703(b) of title 5’’.
1978—Subsec. (g). Pub. L. 95–623 increased limitation
on establishment of positions to one hundred and seventy-nine from one hundred and fifty-five and required
minimum number of positions for certain National
Centers: ten, National Center for Health Services Research; twelve, National Center for Health Statistics;
and seven, National Center for Health Care Technology.
1977—Subsec. (g). Pub. L. 95–83 increased limitation
on establishment of positions to one hundred and fiftyfive from one hundred and fifty and required not less
than five for the National Institute on Alcohol Abuse
and Alcoholism for individuals engaged in research on
alcohol abuse and alcoholism.
1971—Subsec. (f). Pub. L. 92–157, which directed that
‘‘subsection (g)’’ be substituted for ‘‘section 209(f)’’, was
executed by substituting ‘‘section 209(g) of this title’’
for ‘‘section 209(f) of this title’’, to reflect the probable
intent of Congress.
1970—Subsec. (c). Pub. L. 91–515 extended coverage to
encompass members of other national review councils
or national advisory or review committees established
under this chapter, including members of the Technical
Electronic Product Radiation Safety Standards Committee and the Board of Regents of the National Library of Medicine, authorized service to be at the request of the Secretary in place of the Surgeon General,
and revised rates of compensation and travel allowances.
1968—Subsec. (g). Pub. L. 90–574 inserted ‘‘(1)’’ after
‘‘nor more than’’ and added cl. (2).
1962—Subsec. (b). Pub. L. 87–649 struck out sentence
which permitted commissioned officers on active duty
to make allotments from their pay, and substituted
‘‘Commissioned officers on active duty and retired officers’’ for ‘‘Such officers, and retired officers.’’ See section 704 of Title 37, Pay and Allowances of the Uniformed Services.
Subsec. (g). Pub. L. 87–793 substituted provisions requiring the rates of compensation to be not less than
the minimum rate of grade 16 nor more than the highest rate of grade 18 of the General Schedule, for provisions which prescribed annual rates of compensation of
not less than $12,500 nor more than $19,000.
1960—Subsec. (b). Pub. L. 86–415 authorized retired officers entitled to retired pay pursuant to section
211(g)(3), 212, or 213a(a) of this title, to purchase supplies, and included the purchase of supplies from the
Air Force.
Subsec. (g). Pub. L. 86–703 substituted ‘‘one hundred
and fifty’’ for ‘‘eighty-five’’ and ‘‘one hundred and fifteen’’ for ‘‘seventy-three’’.
1958—Subsec. (g). Pub. L. 85–929 substituted ‘‘in the
professional, scientific, and executive service’’ for ‘‘in
the professional and scientific service’’, and substituted

§ 210

‘‘of specially qualified scientific, professional, and administrative personnel’’ for ‘‘of specially qualified scientific or professional personnel’’.
Pub. L. 85–462, substituted ‘‘eighty-five positions, of
which not less than seventy-three shall be for the National Institutes of Health’’ for ‘‘sixty positions’’.
1956—Subsec. (g). Act June 29, 1956, substituted
‘‘$20,000’’ for ‘‘$15,000’’.
1955—Subsec. (g). Act Aug. 1, 1955, increased from
thirty to sixty the number of positions which the Administrator may establish in the professional and scientific service.
1950—Subsec. (b). Act Aug. 9, 1950, struck out ‘‘and
may be granted leaves of absence without any deduction from their pay’’ after ‘‘allotments from their pay’’
in first sentence.
Subsec. (c). Act Aug. 15, 1950, § 3(e), made provisions
applicable to members of all national advisory councils.
Subsec. (g). Act Aug. 15, 1950, § 4(b), added subsec. (g).
1949—Subsec. (a). Act Oct. 12, 1949, made section applicable to Reserve officers.
Subsec. (b). Act Oct. 12, 1949, redesignated subsec. (c)
as (b) and repealed former subsec. (b) relating to Reserve officers.
Subsec. (c). Act Oct. 12, 1949, redesignated subsec. (e)
as (c). Former subsec. (c) redesignated (b).
Subsec. (d). Act Oct. 12, 1949, redesignated subsec. (f)
as (d) and repealed former subsec. (d) relating to female
commissioned officers and defining ‘‘dependent’’.
Subsec. (e). Act Oct. 12, 1949, redesignated subsec. (g)
as (e) and struck out references to allowances. Former
subsec. (e) redesignated (c).
Subsec. (f). Act Oct. 12, 1949, redesignated subsec. (h)
as (f). Former subsec. (f) redesignated (d).
Subsecs. (g), (h). Act Oct. 12, 1949, redesignated subsecs. (g) and (h) as (e) and (f), respectively.
1948—Subsec. (b). Act Feb. 28, 1948, inserted ‘‘except
as otherwise provided by law’’.
Subsec. (e). Acts June 16, 1948, § 4(d), and June 24, 1948,
§ 4(d), made section applicable to the National Advisory
Heart Council and increased the per diem of all members from $25 to $50, and made section applicable to the
National Advisory Dental Research Council, respectively.
Subsec. (h). Act Feb. 28, 1948, substituted ‘‘section
209(f) of this title’’ for ‘‘section 209(d) of this title’’.
1946—Subsec. (e). Act July 3, 1946, inserted ‘‘members
of the National Advisory Mental Health Council’’.
CHANGE OF NAME
Reference to the Gillis W. Long Hansen’s Disease
Center deemed to refer to the National Hansen’s Disease Programs Center, pursuant to section 2 of Pub. L.
107–220, set out as a note under section 247e of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Section 17002(a)(2) of Pub. L. 99–272 provided that:
‘‘The amendment made by paragraph (1) [amending this
section] shall take effect as of October 7, 1985.’’
EFFECTIVE DATE OF 1985 AMENDMENT
Section 3(b) of Pub. L. 99–117 provided that: ‘‘The
amendment made by subsection (a) [amending this section] shall not diminish any benefits under an agreement entered into before the date of enactment of this
Act [Oct. 7, 1985] by a commissioned medical officer in
the Regular Corps or the Reserve Corps of the Public
Health Service.’’
EFFECTIVE DATE OF 1962 AMENDMENTS
Amendment by Pub. L. 87–793 effective first day of
first pay period which begins on or after Oct. 11, 1962,
see section 1008 of Pub. L. 87–793.
Amendment by Pub. L. 87–649 effective Nov. 1, 1962,
see section 15 of Pub. L. 87–649, set out as an Effective
Date note preceding section 101 of Title 37, Pay and Allowances of the Uniformed Services.

§ 210–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 62

EFFECTIVE DATE OF 1960 AMENDMENT

TERMINATION OF ADVISORY COMMITTEES

Amendment by Pub. L. 86–415 effective July 1, 1960,
see section 8(a) of Pub. L. 86–415, set out as a note under
section 209 of this title.

Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

EFFECTIVE DATE OF 1958 AMENDMENTS
Amendment by Pub. L. 85–929 effective Sept. 6, 1958,
see section 6(a) of Pub. L. 85–929, set out as a note under
section 342 of Title 21, Food and Drugs.
Amendment by Pub. L. 85–462 effective June 20, 1958,
see section 17(b) of Pub. L. 85–462.
EFFECTIVE DATE OF 1956 AMENDMENT
Amendment by act July 31, 1956, effective at beginning of first pay period commencing after June 30, 1956,
see section 120 of act July 31, 1956.
EFFECTIVE DATE OF 1950 AMENDMENT
Section 3(a) of act Aug. 9, 1950, provided that: ‘‘Sections 1 and 2 of this Act [amending this section and enacting section 210–1 of this title] shall become effective
on July 1, 1950.’’
EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
REPEALS
Act July 31, 1956, ch. 804, title I, § 117(b), 70 Stat. 741,
cited as a credit to this section, which amended subsec.
(g) of this section to increase the salary rates, was repealed by Pub. L. 88–426, title III, § 305(1), Aug. 14, 1964,
78 Stat. 422.
TRANSFER OF FUNCTIONS
‘‘Director of the Office of Personnel Management’’
substituted for ‘‘Civil Service Commission’’ in subsec.
(g) pursuant to Reorg. Plan No. 2 of 1978, § 102, 43 F.R.
36037, 92 Stat. 3783, set out under section 1101 of Title
5, Government Organization and Employees, which
transferred functions vested by statute in United
States Civil Service Commission to Director of Office
of Personnel Management (except as otherwise specified), effective Jan. 1, 1979, as provided by section 1–102
of Ex. Ord. No. 12107, Dec. 28, 1978, 44 F.R. 1055, set out
under section 1101 of Title 5.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, eff.
Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
MAXIMUM PAY AND ALLOWANCES FOR SPECIFIC FISCAL
YEARS
Pub. L. 100–436, title II, § 208, Sept. 20, 1988, 102 Stat.
1699, provided in part that: ‘‘No funds appropriated for
the fiscal year ending September 30, 1989, by this or any
other Act, may be used to pay basic pay, special pays,
basic allowances for subsistence and basic allowances
for quarters of the commissioned corps of the Public
Health Service described in section 204 of title 42,
United States Code, at a level that exceeds 110 percent
of the Executive Level I [5 U.S.C. 5312] annual rate of
basic pay’’.
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 100–202, § 101(h) [title II, § 208], Dec. 22, 1987, 101
Stat. 1329–256, 1329–274.
Pub. L. 99–500, § 101(i) [H.R. 5233, title II, § 208], Oct. 18,
1986, 100 Stat. 1783–287, and Pub. L. 99–591, § 101(i) [H.R.
5233, title II, § 208], Oct. 30, 1986, 100 Stat. 3341–287.
Pub. L. 99–178, title II, § 208, Dec. 12, 1985, 99 Stat. 1119.
Pub. L. 98–619, title II, § 208, Nov. 8, 1984, 98 Stat. 3321.
Pub. L. 98–139, title II, § 208, Oct. 31, 1983, 97 Stat. 888.
NURSES AND ALLIED HEALTH PROFESSIONALS
Pub. L. 100–436, title II, § 214, Sept. 20, 1988, 102 Stat.
1700, provided that: ‘‘Funds made available for fiscal
year 1989 and hereafter to the National Institutes of
Health shall be available for payment of nurses and allied health professionals using pay, schedule options,
benefits, and other authorities as provided for the
nurses of the Veterans’ Administration under 38 U.S.C.
chapter 73.’’

§ 210–1. Annual and sick leave
(a) Regulations
In accordance with regulations of the President, commissioned officers of the Regular
Corps and officers of the Reserve Corps on active
duty may be granted annual leave and sick leave
without any deductions from their pay and allowances: Provided, That such regulations shall
not authorize annual leave to be accumulated in
excess of sixty days.
(b) Repealed. Pub. L. 87–649, § 14b, Sept. 7, 1962,
76 Stat. 499
(c) Repealed. Pub. L. 96–76, title III, § 311, Sept.
29, 1979, 93 Stat. 586
(d) Definitions
For purposes of this section the term ‘‘accumulated annual leave’’ means unused accrued
annual leave carried forward from one leave
year into a succeeding leave year, and the term
‘‘accrued annual leave’’ means the annual leave
accruing to an officer during one leave year.
(July 1, 1944, ch. 373, title II, § 219, as added Aug.
9, 1950, ch. 654, § 2, 64 Stat. 426; amended Pub. L.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

87–649, § 14b, Sept. 7, 1962, 76 Stat. 499; Pub. L.
96–76, title III, § 311, Sept. 29, 1979, 93 Stat. 586.)
PARTIAL REPEAL OF SUBSECTION (d)
Subsection (d) of this section was repealed by
Pub. L. 87–649, § 14b, Sept. 7, 1962, 76 Stat. 499,
insofar as it was applicable to the last sentence
of subsection (c) of this section which authorized a lump-sum payment to an officer credited
with unused accumulated and accrued annual
leave. See section 501 of Title 37, Pay and Allowances of the Uniformed Services.
AMENDMENTS
1979—Subsec. (c). Pub. L. 96–76, repealed subsec. (c)
which set forth limitations on granting of annual leave
under subsec. (a) of this section.
1962—Subsec. (b). Pub. L. 87–649 repealed subsec. (b)
which required forfeiture of all pay and allowances of
an officer absent without leave. See section 503 of Title
37, Pay and Allowances of the Uniformed Services.
Subsec. (c). Pub. L. 87–649 repealed last sentence
which authorized a lump-sum payment for unused accumulated and accrued annual leave on date of separation, retirement, or release from active duty. See section 501 of Title 37, Pay and Allowances of the Uniformed Services.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87–649 effective Nov. 1, 1962,
see section 15 of Pub. L. 87–649, set out as an Effective
Date note preceding section 101 of Title 37, Pay and Allowances of the Uniformed Services.
EFFECTIVE DATE
Section effective July 1, 1950, see section 3(a) of act
Aug. 9, 1950, set out as an Effective Date of 1950 Amendment note under section 210 of this title.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, of Surgeon General of Public Health Service, and all other officers and
employees of Public Health Service, and functions of
all agencies of or in Public Health Service transferred
to Secretary of Health, Education, and Welfare by
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, set out as a note under section 202 of this
title. Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by
section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20, Education.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.
30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.
COMPENSATION FOR PRIOR ACCUMULATED AND ACCRUED
LEAVE; LIMITATION; INAPPLICABLE TO OFFICERS ON
TERMINAL LEAVE PRIOR TO JULY 1, 1950
Section 3(b), (c) of act Aug. 9, 1950, provided that any
officer credited with more than sixty days of accumulated and accrued leave on June 30, 1949, be compensated for so much of such leave as exceeds sixty
days, that such compensation be due and payable on
July 1, 1950, and that the provisions of this Act not
apply to any officer on terminal leave preceding separation, retirement, or release from active duty.
AVAILABILITY OF FUNDS
Section 4 of act Aug. 9, 1950, provided for the availability of funds for payment of compensation for prior
accumulated and accrued leave for any officer under
section 3 of this Act.
LEAVE REGULATIONS
Act Aug. 9, 1950, ch. 654, § 5, 64 Stat. 427, provided
that: ‘‘Except insofar as the provisions of this Act [en-

§ 210b

acting this section, amending section 210 of this title,
and enacting provisions set out as notes under this section and section 210 of this title] are inconsistent therewith, leave regulations adopted prior to the enactment
of this Act [Aug. 9, 1950], pursuant to the Public Health
Service Act [this chapter], shall remain in effect until
repealed, amended, or superseded.’’

§ 210a. Repealed. Pub. L. 87–649, § 14b, Sept. 7,
1962, 76 Stat. 499
Section, act Feb. 28, 1948, ch. 83, § 5(e), (f), 62 Stat. 41,
related to service credit for commissioned officers on
active duty Feb. 28, 1948, and to service credit for pay
and promotion purposes of certain appointees during
period Feb. 28, 1948, to July 1, 1948.

§ 210b. Professional categories
(a) Division of corps; basis of categories
For the purpose of establishing eligibility of
officers of the Regular Corps for promotions, the
Surgeon General shall by regulation divide the
corps into professional categories. Each category shall, as far as practicable, be based upon
one of the subjects of examination set forth in
section 209(a)(1) of this title or upon a subdivision of such subject, and the categories shall be
designed to group officers by fields of training in
such manner that officers in any one grade in
any one category will be available for similar
duty in the discharge of the several functions of
the Service.
(b) Assignment of officers
Each officer of the Regular Corps on active
duty shall, on the basis of his training and experience, be assigned by the Surgeon General to
one of the categories established by regulations
under subsection (a) of this section. Except upon
amendment of such regulations, no assignment
so made shall be changed unless the Surgeon
General finds (1) that the original assignment
was erroneous, or (2) that the officer is equally
well qualified to serve in another category to
which he has requested to be transferred, and
that such transfer is in the interests of the Service.
(c) Maximum number of officers in each category
Within the limits fixed by the Secretary in
regulations under section 207(d) of this title for
any fiscal year, the Surgeon General shall determine for each category in the Regular Corps the
maximum number of officers authorized to be in
each of the grades from the warrant officer
(W–1) grade to the director grade, inclusive.
(d) Vacancies in grade for purposes of promotion
The excess of the number so fixed for any
grade in any category over the number of officers of the Regular Corps on active duty in such
grade in such category (including in the case of
the director grade, officers holding such grade in
accordance with section 207(c) of this title) shall
for the purpose of promotions constitute vacancies in such grade in such category. For purposes of this subsection, an officer who has been
temporarily promoted or who is temporarily
holding the grade of director in accordance with
section 207(c) of this title shall be deemed to
hold the grade to which so promoted or which he
is temporarily holding; but while he holds such
promotion or grade, and while any officer is

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

temporarily assigned to a position pursuant to
section 206(c) of this title, the number fixed
under subsection (c) of this section for the grade
of his permanent rank shall be reduced by one.
(e) Absence of vacancy in grade as affecting promotion
The absence of a vacancy in a grade in a category shall not prevent an appointment to such
grade pursuant to section 209 of this title, a permanent length of service promotion, or the recall of a retired officer to active duty; but the
making of such an appointment, promotion, or
recall shall be deemed to fill a vacancy if one exists.
(f) Vacancy in grade as affecting maximum number for each category
Whenever a vacancy exists in any grade in a
category the Surgeon General may increase by
one the number fixed by him under subsection
(c) of this section for the next lower grade in the
same category, without regard to the numbers
fixed in regulations under section 207(d) of this
title; and in that event the vacancy in the higher grade shall not be filled except by a permanent promotion, and upon the making of such
promotion the number for the next lower grade
shall be reduced by one.
(July 1, 1944, ch. 373, title II, § 209, as added Feb.
28, 1948, ch. 83, § 5(i), 62 Stat. 41; amended 1953
Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Pub. L. 96–76, title III, § 306,
Sept. 29, 1979, 93 Stat. 585.)
PRIOR PROVISIONS
A prior section 209 of act July 1, 1944, was renumbered
section 208 and is classified to section 210 of this title.
AMENDMENTS
1979—Subsec. (c). Pub. L. 96–76 substituted ‘‘warrant
officer (W–1)’’ for ‘‘assistant’’.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–76 effective Oct. 1, 1979, see
section 314 of Pub. L. 96–76, set out as a note under section 206 of this title.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 211. Promotion of commissioned officers
(a) Permanent or temporary promotions; examination
Promotions of officers of the Regular Corps to
any grade up to and including the director grade

Page 64

shall be either permanent promotions based on
length of service, other permanent promotions
to fill vacancies, or temporary promotions. Permanent promotions shall be made by the President, by and with the advice and consent of the
Senate, and temporary promotions shall be
made by the President. Each permanent promotion shall be to the next higher grade, and
shall be made only after examination given in
accordance with regulations of the President.
(b) Promotion to certain grades only to fill vacancies; regulations; ‘‘restricted grade’’ defined
The President may by regulation provide that
in a specified professional category permanent
promotions to the senior grade, or to both the
full grade and the senior grade, shall be made
only if there are vacancies in such grade. A
grade in any category with respect to which
such regulations have been issued is referred to
in this section as a ‘‘restricted grade’’.
(c) Examinations
Examinations to determine qualification for
permanent promotions may be either noncompetitive or competitive, as the Surgeon General shall in each case determine; except that
examinations for promotions to the assistant or
senior assistant grade shall in all cases be noncompetitive. The officers to be examined shall
be selected by the Surgeon General from the
professional category, and in the order of seniority in the grade, from which promotion is to be
recommended. In the case of a competitive examination the Surgeon General shall determine
in advance of the examination the number
(which may be one or more) of officers who,
after passing the examination, will be recommended to the President for promotion; but if
the examination is one for promotions based on
length of service, or is one for promotions to fill
vacancies other than vacancies in the director
grade or in a restricted grade, such number shall
not be less than 80 per centum of the number of
officers to be examined.
(d) Permanent promotions to qualified officers
on length of service
Officers of the Regular Corps, found pursuant
to subsection (c) of this section to be qualified,
shall be given permanent promotions based on
length of service, as follows:
(1) Officers in the warrant officer (W–1)
grade, chief warrant officer (W–2) grade, chief
warrant officer (W–3) grade, chief warrant officer (W–4) grade, and junior assistant grade
shall be promoted at such times as may be
prescribed in regulations of the President.
(2) Officers with permanent rank in the assistant grade, the senior assistant grade, and
the full grade shall (except as provided in regulations under subsection (b) of this section)
be promoted after completion of three, ten,
and seventeen years, respectively, of service in
grades above the junior assistant grade; and
such promotions, when made, shall be effective, for purposes of pay and seniority in
grade, as of the day following the completion
of such years of service. An officer with permanent rank in the assistant, senior assistant,
or full grade who has not completed such years

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

of service shall be promoted at the same time,
and his promotion shall be effective as of the
same day, as any officer junior to him in the
same grade in the same professional category
who is promoted under this paragraph.
(e) Promotion of professional category officers to
fill certain vacancies
Officers in a professional category of the Regular Corps, found pursuant to subsection (c) of
this section to be qualified, may be given permanent promotions to fill any or all vacancies in
such category in the senior assistant grade, the
full grade, the senior grade, or the director
grade; but no officer who has not had one year
of service with permanent or temporary rank in
the next lower grade shall be promoted to any
restricted grade or to the director grade.
(f) Reexamination upon failure of promotion; effective date of promotion
If an officer who has completed the years of
service required for promotion to a grade under
paragraph (2) of subsection (d) of this section
fails to receive such promotion, he shall (unless
he has already been twice examined for promotion to such grade) be once reexamined for
promotion to such grade. If he is thereupon promoted (otherwise than under subsection (e) of
this section), the effective date of such promotion shall be one year later than it would
have been but for such failure. Upon the effective date of any permanent promotion of such
officer to such grade, he shall be considered as
having had only the length of service required
for such promotion which he previously failed to
receive.
(g) Separation from service upon failure of promotion
If, for reasons other than physical disability,
an officer of the Regular Corps in the warrant
officer (W–1) grade or junior assistant grade is
found pursuant to subsection (c) of this section
not to be qualified for promotion he shall be separated from the Service. If, for reasons other
than physical disability, an officer of the Regular Corps in the chief warrant officer (W–2), chief
warrant officer (W–3), assistant, senior assistant, or full grade, after having been twice examined for promotion (other than promotion to a
restricted grade), fails to be promoted—
(1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the
Service and paid six months’ basic pay and allowances;
(2) if in the chief warrant officer (W–3) or
senior assistant grade he shall be separated
from the Service and paid one year’s basic pay
and allowances;
(3) if in the full grade he shall be considered
as not in line for promotion and shall, at such
time thereafter as the Surgeon General may
determine, be retired from the Service with retired pay (unless he is entitled to a greater
amount by reason of another provision of
law)—
(A) in the case of an officer who first became a member of a uniformed service before September 8, 1980, at the rate of 21⁄2 percent of the retired pay base determined
under section 1406(h) of title 10 for each year,

§ 211

not in excess of 30, of his active commissioned service in the Service; or
(B) in the case of an officer who first became a member of a uniformed service on or
after September 8, 1980, at the rate determined by multiplying—
(i) the retired pay base determined under
section 1407 of title 10; by
(ii) the retired pay multiplier determined under section 1409 of such title for
the number of years of his active commissioned service in the Service.
(h) Separation from service upon refusal to
stand examination
If an officer of the Regular Corps, eligible to
take an examination for promotion, refuses to
take such examination, he may be separated
from the Service in accordance with regulations
of the President.
(i) Review of record; separation from service
At the end of his first three years of service,
the record of each officer of the Regular Corps
originally appointed to the senior assistant
grade or above, shall be reviewed in accordance
with regulations of the President and, if found
not qualified for further service, he shall be separated from the Service and paid six months’
pay and allowances.
(j) Determination of order of seniority
(1) The order of seniority of officers in a grade
in the Regular Corps shall be determined, subject to the provisions of paragraph (2) of this
subsection, by the relative length of time spent
in active service after the effective date of each
such officer’s original appointment or permanent promotion to that grade. When permanent
promotions of two or more officers to the same
grade are effective on the same day, their relative seniority shall be the same as it was in the
grade from which promoted. In all other cases of
original appointments or permanent promotions
(or both) to the same grade effective on the
same day, relative seniority shall be determined
in accordance with regulations of the President.
(2) In the case of an officer originally appointed in the Regular Corps to the grade of assistant or above, his seniority in the grade to
which appointed shall be determined after inclusion, as service in such grade, of any active service in such grade or in any higher grade in the
Reserve Corps, but (if the appointment is to the
grade of senior assistant or above) only to the
extent of whichever of the following is greater:
(A) His active service in such grade or any higher grade in the Reserve Corps after the first day
on which, under regulations in effect on the date
of his appointment to the Regular Corps, he had
the training and experience necessary for such
appointment, or (B) the excess of his total active service in the Reserve Corps (above the
grade of junior assistant) over three years if his
appointment in the Regular Corps is to the senior assistant grade, over ten years if the appointment is to the full grade, or over seventeen
years if the appointment is to the senior grade.
(k) Temporary promotions; fill vacancy in higher
grade; war or national emergency; selection
of officers; termination of appointment
Any commissioned officer of the Regular
Corps in any grade in any professional category

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

may be recommended to the President for temporary promotion to fill a vacancy in any higher
grade in such category, up to and including the
director grade. In time of war, or of national
emergency proclaimed by the President, any
commissioned officer of the Regular Corps in
any grade in any professional category may be
recommended to the President for promotion to
any higher grade in such category, up to and including the director grade, whether or not a vacancy exists in such grade. The selection of officers to be recommended for temporary promotions shall be made in accordance with regulations of the President. Promotion of an officer
recommended pursuant to this subsection may
be made without regard to length of service,
without examination, and without vacating his
permanent appointment, and shall carry with it
the pay and allowances of the grade to which
promoted. Such promotions may be terminated
at any time, as may be directed by the President.
(l) Determination of requirements of Service by
Secretary; assignment of Reserve Officers to
professional categories; temporary promotions; termination of temporary promotions
Whenever the number of officers of the Regular Corps on active duty, plus the number of officers of the Reserve Corps who have been on active duty for thirty days or more, exceeds the
authorized strength of the Regular Corps, the
Secretary shall determine the requirements of
the Service in each grade in each category,
based upon the total number of officers so serving on active duty and the tasks being performed by the Service; and the Surgeon General
shall thereupon assign each officer of the Reserve Corps on active duty to a professional category. If the Secretary finds that the number of
officers fixed under section 210b(c) of this title
for any grade and category (or the number of officers, including officers of the Reserve Corps,
on active duty in such grade in such category, if
such number is greater than the number fixed
under section 210b(c) of this title) is insufficient
to meet such requirements of the Service, officers of either the Regular Corps or the Reserve
Corps may be recommended for temporary promotion to such grade in such category. Any such
promotion may be terminated at any time, as
may be directed by the President.
(m) Acceptance of promotion; oath and affidavit
Any officer of the Regular Corps, or any officer of the Reserve Corps on active duty, who is
promoted to a higher grade shall, unless he expressly declines such promotion, be deemed for
all purposes to have accepted such promotion;
and shall not be required to renew his oath of office, or to execute a new affidavit as required by
section 3332 of title 5.
(July 1, 1944, ch. 373, title II, § 210, 58 Stat. 687;
Feb. 28, 1948, ch. 83, § 6(a), 62 Stat. 42; Oct. 12,
1949, ch. 681, title V, § 521(c), 63 Stat. 835; 1953
Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Apr. 27, 1956, ch. 211, § 4(a), 70
Stat. 117; Pub. L. 86–415, § 5(c), Apr. 8, 1960, 74
Stat. 34; Pub. L. 87–649, § 11(2), Sept. 7, 1962, 76
Stat. 497; Pub. L. 96–76, title III, § 307, Sept. 29,

Page 66

1979, 93 Stat. 585; Pub. L. 96–342, title VIII,
§ 813(h)(1), Sept. 8, 1980, 94 Stat. 1110; Pub. L.
99–348, title II, § 207(a), July 1, 1986, 100 Stat. 701.)
CODIFICATION
In subsec. (m), ‘‘section 3332 of title 5’’ substituted for
‘‘the Act of December 11, 1926, as amended (5 U.S.C.
21a)’’ on authority of Pub. L. 89–554, § 7(b), Sept. 6, 1966,
80 Stat. 631, the first section of which enacted Title 5,
Government Organization and Employees.
AMENDMENTS
1986—Subsec. (g)(3). Pub. L. 99–348 added subpars. (A)
and (B) and struck out former subpars. (A) and (B)
which read as follows:
‘‘(A) in the case of an officer who first became a
member of a uniformed service before September 8,
1980, at the rate of 21⁄2 per centum of basic pay of the
permanent grade held by him at the time of retirement
for each year, not in excess of thirty, of his active commissioned service in the Service; or
‘‘(B) in the case of an officer who first became a member of a uniformed service on or after September 8, 1980,
1
2 ⁄2 per centum of the monthly retired pay base computed under section 1407(h) of title 10, for each year,
not in excess of thirty, of his active commissioned service in the Service.’’
1980—Subsec. (g)(3). Pub. L. 96–342 revised provisions
into subpars. (A) and (B) and substituted provisions respecting computation of retired pay for officers who became members of the uniformed service before Sept. 8,
1980, and for officers who became members of the uniformed service on or after Sept. 8, 1980, for provisions
respecting computation of retired pay for officers.
1979—Subsec. (d)(1). Pub. L. 96–76, § 307(a), inserted applicability to warrant officers and chief warrant officers.
Subsec. (g). Pub. L. 96–76, § 307(b), in provision before
par. (1), inserted applicability to separation from Service of warrant officers and chief warrant officers subsequent to one examination or two examinations, respectively, in par. (1), inserted applicability to a chief warrant officer (W–2), and in par. (2), inserted applicability
to a chief warrant officer (W–3).
1962—Subsec. (g). Pub. L. 87–649 substituted ‘‘basic
pay’’ for ‘‘pay’’ in cls. (1) and (2).
1960—Subsec. (g). Pub. L. 86–415 substituted ‘‘of the
basic pay of the permanent grade held by him at the
time of retirement for each year’’ for ‘‘of his active
duty pay at the time of retirement for each complete
year’’ in cl. (3).
1956—Subsec. (d)(2). Act Apr. 27, 1956, struck out ‘‘pay
period and for purposes of’’ before ‘‘seniority in grade’’.
1949—Subsec. (g). Act Oct. 12, 1949, struck out ‘‘incurred in line of duty’’ wherever appearing.
1948—Act Feb. 28, 1948, amended subsecs. (a) to (c)
generally and added subsecs. (d) to (m).
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–76 effective Oct. 1, 1979, see
section 314 of Pub. L. 96–76, set out as a note under section 206 of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87–649 effective Nov. 1, 1962,
see section 15 of Pub. L. 87–649, set out as an Effective
Date note preceding section 101 of Title 37, Pay and Allowances of the Uniformed Services.
EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and em-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ployees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 this title. Federal Security Agency
and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.
30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§ 211a. Repealed. Pub. L. 93–222, § 7(b), Dec. 29,
1973, 87 Stat. 936
Section, act July 1, 1944, ch. 373, title XIII, § 1311, formerly title VII, § 711, as added Feb. 28, 1948, ch. 83, § 9(b),
62 Stat. 47; renumbered title VIII, § 811, July 30, 1956, ch.
779, § 3(b), 70 Stat. 721; renumbered title IX, § 911, Sept.
4, 1964, Pub. L. 88–581, § 4(b), 78 Stat. 919; renumbered
title X, § 1011, Oct. 6, 1965, Pub. L. 89–239, § 3(b), 79 Stat.
931; renumbered title XI, § 1111, Dec. 24, 1970, Pub. L.
91–572, § 6(b), 84 Stat. 1506; renumbered title XII, § 1211,
May 16, 1972, Pub. L. 92–294, § 3(b), 86 Stat. 137; renumbered title XIII, § 1311, Nov. 16, 1973, Pub. L. 93–154,
§ 2(b)(2), 87 Stat. 604, provided for appointment to higher grades of Public Health Service officers for mental
health and hospital construction activities.

§ 211b. Repealed. Pub. L. 94–412, title V, § 501(f),
Sept. 14, 1976, 90 Stat. 1258
Section, act Feb. 28, 1948, ch. 83, § 6(b)–(f), 62 Stat. 45,
dealt with promotion of Public Health Service officers.
SAVINGS PROVISION
Repeal not to affect any action taken or proceeding
pending at the time of repeal, see section 501(h) of Pub.
L. 94–412, set out as a note under section 1601 of Title
50, War and National Defense.

§ 211c. Promotion credit for medical officers in
assistant grade
Any medical officer of the Regular Corps of
the Public Health Service who—
(1)(A) was appointed to the assistant grade
in the Regular Corps and whose service in such
Corps has been continuous from the date of appointment or (B) may hereafter be appointed
to the assistant grade in the Regular Corps,
and
(2) had or will have completed a medical internship on the date of such appointment,
shall be credited with one year for purposes of
promotion and seniority in grade, except that no
such credit shall be authorized if the officer has
received or will receive similar credit for his internship under other provisions of law. In the
case of an officer on active duty on the effective
date of this section who is entitled to the credit

§ 212

authorized herein, the one year shall be added to
the promotion and seniority-in-grade credits
with which he is credited on such date.
(July 1, 1944, ch. 373, title II, § 220, as added Apr.
30, 1956, ch. 223, § 3, 70 Stat. 121.)
REFERENCES IN TEXT
For ‘‘the effective date of this section’’, referred to in
text, see section 7 of act Apr. 30, 1956, which provided
in part that this section shall become effective the first
day of the month following the day of enactment, Apr.
30, 1956.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 212. Retirement of commissioned officers
(a) Age; voluntariness; length of service; computation of retired pay
(1) A commissioned officer of the Service
shall, if he applies for retirement, be retired on
or after the first day of the month following the
month in which he attains the age of sixty-four
years. This paragraph does not permit or require
the involuntary retirement of any individual because of the age of the individual.
(2) A commissioned officer of the Service may
be retired by the Secretary, and shall be retired
if he applies for retirement, on the first day of
any month after completion of thirty years of
active service.
(3) Any commissioned officer of the Service
who has had less than thirty years of active
service may be retired by the Secretary, with or
without application by the officer, on the first
day of any month after completion of twenty or
more years of active service of which not less
than ten are years of active commissioned service in any of the uniformed services.
(4) Except as provided in paragraph (6), a commissioned officer retired pursuant to paragraph
(1), (2), or (3) who was (in the case of an officer
in the Reserve Corps) on active duty with the
Service on the day preceding such retirement
shall be entitled to receive retired pay at the
rate of 21⁄2 per centum of the basic pay of the
highest grade held by him as such officer and in
which, in the case of a temporary promotion to
such grade, he has performed active duty for not
less than six months, (A) for each year of active
service, or (B) if it results in higher retired pay,
for each of the following years:
(i) his years of active service (determined
without regard to subsection (d) of this section) as a member of a uniformed service; plus
(ii) in the case of a medical or dental officer,
four years and, in the case of a medical officer,
who has completed one year of medical internship or the equivalent thereof, one additional
year, the four years and the one year to be reduced by the period of active service performed during such officer’s attendance at

§ 212

TITLE 42—THE PUBLIC HEALTH AND WELFARE

medical school or dental school or during his
medical internship; plus
(iii) the number of years of service with
which he was entitled to be credited for purposes of basic pay on May 31, 1958, or (if higher) on any date prior thereto, reduced by any
such year included under clause (i) and further
reduced by any such year with which he was
entitled to be credited under paragraphs (7)
and (8) of section 205(a) of title 37 on any date
before June 1, 1958;
except that (C) in the case of any officer whose
retired pay, so computed, is less than 50 per centum of such basic pay, who retires pursuant to
paragraph (1) of this subsection, who has not
less than twelve whole years of active service
(computed without the application of subsection
(e) of this section), and who does not use, for
purposes of a retirement annuity under subchapter III of chapter 83 of title 5, any service
which is also creditable in computing his retired
pay from the Service, it shall, instead, be 50 per
centum of such pay, and (D) the retired pay of
an officer shall in no case be more than 75 per
centum of such basic pay.
(5) With the approval of the President, a commissioned officer whose service as Surgeon General, Deputy Surgeon General, or Assistant Surgeon General has totaled four years or more and
who has had not less than twenty-five years of
active service in the Service may retire voluntarily at any time; and except as provided in
paragraph (6), his retired pay shall be at the rate
of 75 per centum of the basic pay of the highest
grade held by him as such officer.
(6) The retired pay of a commissioned officer
retired under this subsection who first became a
member of a uniformed service after September
7, 1980, is determined by multiplying—
(A) the retired pay base determined under
section 1407 of title 10; by
(B) the retired pay multiplier determined
under section 1409 of such title for the number
of years of service credited to the officer under
paragraph (4).
(7) Retired pay computed under section
211(g)(3) of this title or under paragraph (4) or (5)
of this subsection, if not a multiple of $1, shall
be rounded to the next lower multiple of $1.
(b) Basic pay of highest temporary grade
For purposes of subsection (a) of this section,
the basic pay of the highest grade to which a
commissioned officer has received a temporary
promotion means the basic pay to which he
would be entitled if serving on active duty in
such grade on the date of his retirement.
(c) Recall to active duty
A commissioned officer, retired for reasons
other than for failure of promotion to the senior
grade, may (1) if an officer of the Regular Corps
or an officer of the Reserve Corps entitled to retired pay under subsection (a) of this section, be
involuntarily recalled to active duty during
such times as the Commissioned Corps constitutes a branch of the land or naval forces of
the United States, and (2) if an officer of either
the Regular or Reserve Corps, be recalled to active duty at any time with his consent.

Page 68

(d) ‘‘Active service’’ defined
The term ‘‘active service’’, as used in subsection (a) of this section, includes:
(1) all active service in any of the uniformed
services;
(2) active service with the Public Health
Service, other than as a commissioned officer,
which the Surgeon General determines is comparable to service performed by commissioned
officers of the Service, except that, if there are
more than five years of such service only the
last five years thereof may be included;
(3) all active service (other than service included under the preceding provisions of this
subsection) which is creditable for retirement
purposes under laws governing the retirement
of members of any of the uniformed services;
and
(4) service performed as a member of the
Senior Biomedical Research Service established by section 237 of this title, except that,
if there are more than 5 years of such service,
only the last 5 years thereof may be included.
(e) Crediting of part of year
For the purpose of determining the number of
years by which a percentage of the basic pay of
an officer is to be multiplied in computing the
amount of his retired pay pursuant to section
211(g)(3) of this title or paragraph (4) of subsection (a) of this section, each full month of
service that is in addition to the number of full
years of service credited to an officer is counted
as one-twelfth of a year and any remaining fractional part of a month is disregarded.
(f) Retirement or separation for physical disability
For purposes of retirement or separation for
physical disability under chapter 61 of title 10, a
commissioned officer of the Service shall be
credited, in addition to the service described in
section 1208(a)(2) of that title, with active service with the Public Health Service, other than
as a commissioned officer, which the Surgeon
General determines is comparable to service
performed by commissioned officers of the Service, except that, if there are more than five
years of such service, only the last five years
thereof may be so credited. For such purposes,
such section 1208(a)(2) shall be applicable to officers of the Regular or Reserve Corps of the Service.
(July 1, 1944, ch. 373, title II, § 211, 58 Stat. 688;
Feb. 28, 1948, ch. 83, § 7, 62 Stat. 46; Oct. 12, 1949,
ch. 681, title V, § 521(d), 63 Stat. 835; 1953 Reorg.
Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Apr. 27, 1956, ch. 211, § 5(a)–(c), 70
Stat. 117; Aug. 10, 1956, ch. 1041, § 5, 70A Stat. 620;
Pub. L. 86–415, § 4, Apr. 8, 1960, 74 Stat. 33; Pub.
L. 91–253, § 1, May 14, 1970, 84 Stat. 216; Pub. L.
96–76, title III, § 308, Sept. 29, 1979, 93 Stat. 585;
Pub. L. 96–342, title VIII, § 813(h)(2), Sept. 8, 1980,
94 Stat. 1110; Pub. L. 97–25, title III, § 303(b), July
27, 1981, 95 Stat. 145; Pub. L. 97–35, title XXVII,
§ 2765(a), Aug. 13, 1981, 95 Stat. 932; Pub. L. 98–94,
title IX, §§ 922(d), 923(f), Sept. 24, 1983, 97 Stat.
642, 643; Pub. L. 99–348, title II, § 207(b), July 1,
1986, 100 Stat. 702; Pub. L. 101–509, title V, § 529
[title III, § 304(b)], Nov. 5, 1990, 104 Stat. 1427,
1464.)

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
CODIFICATION

In subsec. (a)(4), ‘‘subchapter III of chapter 83 of title
5’’ substituted for ‘‘the Civil Service Retirement Act’’
on authority of Pub. L. 89–554, § 7(b), Sept. 6, 1966, 80
Stat. 631, the first section of which enacted Title 5,
Government Organization and Employees.
AMENDMENTS
1990—Subsec. (d)(4). Pub. L. 101–509 added par. (4).
1986—Subsec. (a)(6). Pub. L. 99–348 amended par. (6)
generally. Prior to amendment, par. (6) read as follows:
‘‘In computing retired pay under paragraph (4) or (5) in
the case of any commissioned officer who first became
a member of a uniformed service on or after September
8, 1980, the monthly retired pay base computed under
section 1407(h) of title 10 shall be used in lieu of using
the basic pay of the highest grade held by him as such
officer.’’
1983—Subsec. (a)(7). Pub. L. 98–94, § 922(d), added par.
(7).
Subsec. (e). Pub. L. 98–94, § 923(f), substituted ‘‘each
full month of service that is in addition to the number
of full years of service credited to an officer is counted
as one-twelfth of a year and any remaining fractional
part of a month is disregarded’’ for ‘‘a part of a year
that is six months or more is counted as a whole year,
and a part of a year that is less than six months is disregarded’’.
1981—Subsec. (a)(1). Pub. L. 97–35 substituted ‘‘shall,
if he applies for retirement, be retired on or after’’ for
‘‘shall be retired on’’, and substituted provisions relating to involuntary retirement as a result of age, for
provisions relating to inapplicability to the Surgeon
General.
Pub. L. 97–25 inserted provision that this paragraph
does not apply to Surgeon General.
1980—Subsec. (a)(4). Pub. L. 96–342, § 813(h)(2)(A), substituted ‘‘Except as provided in paragraph (6), a’’ for
‘‘A’’.
Subsec. (a)(5). Pub. L. 96–342, § 813(h)(2)(B), substituted ‘‘except as provided in paragraph (6), his’’ for
‘‘his’’.
Subsec. (a)(6). Pub. L. 96–342, § 813(h)(2)(C), added par.
(6).
1979—Subsec. (e). Pub. L. 96–76 struck out requirement respecting active service for purposes of credit.
1970—Subsec. (a)(4). Pub. L. 91–253 inserted ‘‘plus’’
after the semicolon at end of cl. (ii) and added cl. (iii).
1960—Pub. L. 86–415 amended section generally, and
among other changes, authorized retirement of commissioned officers who have had less than 30 years of
active service any time after the completion of 20 years
of active service, permitted persons who have served as
Deputy Surgeons General or Assistant Surgeons General for four or more years and who have had at least
25 years of active service to retire voluntarily at any
time, provided for the recall to active duty of officers
of the Reserve Corps entitled to retired pay under subsection (a) of this section during such times as the
Corps constitutes a branch of the land or naval forces
of the United States, authorized credit, for retirement
purposes, of active service in the uniformed services
and limited to five years the crediting of active service
with the Public Health Service other than as a commissioned officer, and established the methods for computation of retired pay for active duty officers retiring
for age or length of service.
1956—Subsec. (a). Act Apr. 27, 1956, § 5(a), authorized
crediting of noncommissioned service for purposes of
retirement.
Subsec. (b)(1). Act Apr. 27, 1956, § 5(b), authorized
crediting of noncommissioned service in the Service for
purposes of retirement.
Subsec. (c). Act Apr. 27, 1956, § 5(c), permitted recall of
retired officers of the Regular Corps without their consent whenever the Regular Corps has military status,
and authorized recall of retired officers of the Regular
or Reserve Corps with their consent at any time.
Subsec. (g). Act Aug. 10, 1956, provided for crediting of
service for purposes of retirement or separation for
physical disability under chapter 61 of title 10.

§ 212

1949—Subsec. (a). Act Oct. 12, 1949, redesignated subsec. (b) as (a), substituted ‘‘subsection (b)’’ for ‘‘subsection (c)’’ and repealed former subsec. (a) relating to
retirement for disability or disease.
Subsec. (b). Act Oct. 12, 1949, redesignated subsec. (c)
as (b) and struck out reference to retirement for disability or disease. Former subsec. (b) redesignated (a).
Subsec. (c). Act Oct. 12, 1949, redesignated subsec. (d)
as (c) and struck out reference to recovery from a disability. Former subsec. (c) redesignated (b).
Subsecs. (d) to (f). Act Oct. 12, 1949, redesignated subsecs. (e) to (g) as (d) to (f), respectively. Former subsec.
(d) redesignated (c).
Subsecs. (g), (h). Act Oct. 12, 1949, redesignated subsec. (h) as (g) and amended subsection generally to relate to retirement or separation for physical disability.
Former subsec. (g) redesignated (f).
1948—Subsec. (b). Act Feb. 28, 1948, inserted length of
service for retirement purposes.
Subsec. (c)(2). Act Feb. 28, 1948, made subdivision applicable to grade of Assistant Surgeon General.
Subsec. (d). Act Feb. 28, 1948, substituted ‘‘under the
provisions of subsection (b) of this section’’ for ‘‘for
age’’.
Subsecs. (g), (h). Act Feb. 28, 1948, added subsecs. (g)
and (h).
CHANGE OF NAME
Senior Biomedical Research Service changed to
Silvio O. Conte Senior Biomedical Research Service by
Pub. L. 103–43, title XX, § 2001, June 10, 1993, 107 Stat.
208. See section 237 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 529 [title III, § 304(c)] of Pub. L. 101–509 provided that: ‘‘Except as otherwise provided, the provisions of this section [enacting section 237 of this title
and amending this section] shall be effective on the
90th day following the date of the enactment of this
Act [Nov. 5, 1990].’’
EFFECTIVE DATE OF 1983 AMENDMENT
Amendment by section 922(d) of Pub. L. 98–94 effective Oct. 1, 1983, see section 922(e) of Pub. L. 98–94, set
out as a note under section 1401 of Title 10, Armed
Forces.
Amendment by section 923(f) of Pub. L. 98–94 applicable with respect to the computation of retired or retainer pay of any individual who becomes entitled to
that pay after Sept. 30, 1983, see section 923(g) of Pub.
L. 98–94, set out as a note under section 1174 of Title 10.
EFFECTIVE DATE OF 1970 AMENDMENT
Section 2 of Pub. L. 91–253 provided that: ‘‘The
amendments made by this Act [amending this section]
shall apply in the case of retired pay for any period
after the month in which this Act is enacted [May
1970].’’
EFFECTIVE DATE OF 1960 AMENDMENT
Section 8(b) of Pub. L. 86–415 provided that: ‘‘The
amendment made by section 4 [amending this section]
shall become effective on the date of enactment of this
Act [Apr. 8, 1960] in the case of commissioned officers
of the Regular Corps of the Public Health Service, and
on July 1, 1960, in the case of commissioned officers of
the Reserve Corps of the Public Health Service.’’
EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
SAVINGS PROVISION
Pub. L. 86–415, § 8(c), (d), Apr. 8, 1960, 74 Stat. 36, provided that:
‘‘(c) An officer in the Regular Corps on active duty on
the date of enactment of this Act [Apr. 8, 1960] may be

§ 212a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

retired and have his retired pay computed under section 211 of the Public Health Service Act, as amended
by this Act [this section], or, if he so elects, under such
section as in effect prior to the date of enactment of
this Act [Apr. 8, 1960].
‘‘(d) The limitation under subsection (f) of section 211
of the Public Health Service Act, as amended by this
Act [subsec. (f) of this section], on the amount of active
service with the Public Health Service, other than as a
commissioned officer, which may be counted for purposes of retirement or separation for physical disability, shall not apply in the case of any officer of the Reserve Corps of the Public Health Service on active duty
on June 30, 1960.’’
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, eff.
Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.
COVERAGE UNDER CIVIL SERVICE RETIREMENT ACT
Creditable service for purposes of the Civil Service
Retirement Act for certain commissioned officers of
the Regular or Reserve Corps of the Public Health
Service, see section 6(a), (b) of Pub. L. 86–415, set out as
a note under section 8332 of Title 5, Government Organization and Employees.

§ 212a. Repealed. Pub. L. 93–222, § 7(b), Dec. 29,
1973, 87 Stat. 936
Section, act July 1, 1944, ch. 373, title XIII, § 1312, formerly title VII, § 712, as added Feb. 28, 1948, ch. 83, § 9(b),
62 Stat. 47; renumbered title VIII, § 812, July 30, 1956, ch.
779, § 3(b), 70 Stat. 721; renumbered title IX, § 912, Sept.
4, 1964, Pub. L. 88–581, § 4(b), 78 Stat. 919; renumbered
title X, § 1012, Oct. 6, 1965, Pub. L. 89–239, § 3(b), 79 Stat.
931; renumbered title XI, § 1112, Dec. 24, 1970, Pub. L.
91–572, § 6(b), 84 Stat. 1506; renumbered title XII, § 1212,
May 16, 1972, Pub. L. 92–294, § 3(b), 86 Stat. 137; renumbered title XIII, § 1312, Nov. 16, 1973, Pub. L. 93–154,
§ 2(b)(2), 87 Stat. 604, provided for retirement of certain
officers of Reserve Corps of the Public Health Service
for disability.

§ 212b. Repealed. Apr. 27, 1956, ch. 211, § 5(d), 70
Stat. 117
Section, act July 31, 1953, ch. 296, title II, § 201, 67
Stat. 254, authorized recall of retired officers of the
Service. See section 212(c) of this title.

Page 70

§ 213. Military benefits
(a) Rights, privileges, immunities, and benefits
accorded to commissioned officers or their
survivors
Except as provided in subsection (b) of this
section, commissioned officers of the Service
and their surviving beneficiaries shall, with respect to active service performed by such officers—
(1) in time of war;
(2) on detail for duty with the Army, Navy,
Air Force, Marine Corps, or Coast Guard; or
(3) while the Service is part of the military
forces of the United States pursuant to Executive order of the President;
be entitled to all rights, privileges, immunities,
and benefits now or hereafter provided under
any law of the United States in the case of commissioned officers of the Army or their surviving beneficiaries on account of active military
service, except retired pay and uniform allowances.
(b) Award of decorations
The President may prescribe the conditions
under which commissioned officers of the Service may be awarded military ribbons, medals,
and decorations.
(c) Authority of Surgeon General
The authority vested by law in the Department of the Army, the Secretary of the Army,
or other officers of the Department of the Army
with respect to rights, privileges, immunities,
and benefits referred to in subsection (a) of this
section shall be exercised, with respect to commissioned officers of the Service, by the Surgeon
General.
(d) Active service deemed active military service
with respect to laws administered by Secretary of Veterans Affairs
Active service of commissioned officers of the
Service shall be deemed to be active military
service in the Armed Forces of the United
States for the purposes of all laws administered
by the Secretary of Veterans Affairs (except the
Servicemen’s Indemnity Act of 1951) and section
417 of this title.
(e) Active service deemed active military service
with respect to Servicemembers Civil Relief
Act
Active service of commissioned officers of the
Service shall be deemed to be active military
service in the Armed Forces of the United
States for the purposes of all rights, privileges,
immunities, and benefits now or hereafter provided under the Servicemembers Civil Relief Act
(50 App. U.S.C. 501 et seq.).
(f) Active service deemed active military service
with respect to anti-discrimination laws
Active service of commissioned officers of the
Service shall be deemed to be active military
service in the Armed Forces of the United
States for purposes of all laws related to discrimination on the basis of race, color, sex, ethnicity, age, religion, and disability.
(July 1, 1944, ch. 373, title II, § 212, 58 Stat. 689;
July 15, 1954, ch. 507, § 14(a), 68 Stat. 481; Aug. 1,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

1956, ch. 837, title V, § 501(b)(1), 70 Stat. 881; Pub.
L. 94–278, title XI, § 1101, Apr. 22, 1976, 90 Stat.
415; Pub. L. 102–54, § 13(q)(1)(C), June 13, 1991, 105
Stat. 278; Pub. L. 105–392, title IV, § 402(a), Nov.
13, 1998, 112 Stat. 3587; Pub. L. 108–189, § 2(e), Dec.
19, 2003, 117 Stat. 2866.)
REFERENCES IN TEXT
The Servicemen’s Indemnity Act of 1951, referred to
in subsec. (d), is act Apr. 25, 1951, ch. 39, pt. I, 65 Stat.
33, which was classified generally to subchapter II (§ 851
et seq.) of chapter 13 of former Title 38, Pensions, Bonuses, and Veterans’ Relief, and was repealed by act
Aug. 1, 1956, ch. 837, title V, § 502(9), 70 Stat. 886.
The Servicemembers Civil Relief Act, referred to in
subsec. (e), is act Oct. 17, 1940, ch. 888, 54 Stat. 1178, as
amended, which is classified to section 501 et seq. of
Title 50, Appendix, War and National Defense. For complete classification of this Act to the Code, see section
501 of Title 50, Appendix, and Tables.
AMENDMENTS
2003—Subsec. (e). Pub. L. 108–189 substituted
‘‘Servicemembers Civil Relief Act’’ for ‘‘Soldiers’ and
Sailors’ Civil Relief Act of 1940’’.
1998—Subsec. (f). Pub. L. 105–392 added subsec. (f).
1991—Subsec. (d). Pub. L. 102–54 substituted ‘‘Secretary of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1976—Subsec. (e). Pub. L. 94–278 added subsec. (e).
1956—Act Aug. 1, 1956, amended section generally to
extend all rights, privileges, immunities, and benefits
provided for commissioned officers of the Army or their
surviving beneficiaries to commissioned officers of the
Service, with the exception of retired pay and uniform
allowances, when performing duty under certain circumstances, and to provide that active service of commissioned officers shall be deemed to be active military
service in the Armed Forces for the purposes of all laws
administered by the Veterans’ Administration (except
the Servicemen’s Indemnity Act of 1951) and section 417
of this title.
1954—Subsec. (a)(1). Act July 15, 1954, struck out
‘‘burial payments in the event of death,’’ after ‘‘limited
to,’’.
EFFECTIVE DATE OF 1956 AMENDMENT; APPLICABILITY
Act Aug. 1, 1956, ch. 837, title V, § 501(b)(2), 70 Stat.
882, provided that: ‘‘The amendment made by this subsection [amending this section] (A) shall apply only
with respect to service performed on or after July 4,
1952, (B) shall not be construed to affect the entitlement of any person to benefits under the Veterans’ Readjustment Assistance Act of 1952 [act July 16, 1952, ch.
875, 66 Stat. 633], (C) shall not be construed to authorize
any payment under section 202(i) of the Social Security
Act [section 402(i) of this title], or under Veterans Regulation Numbered 9(a), for any death occurring prior to
January 1, 1957, and (D) shall not be construed to authorize payment of any benefits for any period prior to
January 1, 1957.’’
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.

§ 213

1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
RECOMPUTATION OF SOCIAL SECURITY BENEFITS FOR
OFFICERS ENTITLED TO OLD-AGE INSURANCE BENEFITS PRIOR TO JANUARY 1, 1957, OR FOR SURVIVORS
OF OFFICERS WHO DIED PRIOR TO JANUARY 1, 1957
Act Aug. 1, 1956, ch. 837, title V, § 501(b)(3), 70 Stat.
882, provided that: ‘‘In the case of any individual—
‘‘(A) who performed active service (i) as a commissioned officer of the Public Health Service at any
time during the period beginning July 4, 1952, and
ending December 31, 1956, or (ii) as a commissioned
officer of the Coast and Geodetic Survey at any time
during the period beginning July 29, 1945, and ending
December 31, 1956; and
‘‘(B)(i) who became entitled to old-age insurance
benefits under section 202(a) of the Social Security
Act [section 402(a) of this title] prior to January 1,
1957, or
‘‘(ii) who died prior to January 1, 1957, and whose
widow, child, or parent is entitled for the month of
January 1957, on the basis of his wages and self-employment income, to a monthly survivor’s benefit
under section 202 of such act [section 402 of this title];
and
‘‘(C) any part of whose service described in subparagraph (A) was not included in the computation of his
primary insurance amount under section 215 of such
act [section 415 of this title] but would have been included in such computation if the amendment made
by paragraph (1) of this subsection or paragraph (1) of
subsection (d) had been effective prior to the date of
such computation,
the Secretary of Health, Education, and Welfare [now
Health and Human Services] shall, notwithstanding the
provisions of section 215(f)(1) of the Social Security Act
[section 415(f)(1) of this title], recompute the primary
insurance amount of such individual upon the filing of
an application, after December 1956, by him or (if he
dies without filing such an application) by any person
entitled to monthly survivor’s benefits under section
202 of such act [section 402 of this title] on the basis of
his wages and self-employment income. Such recomputation shall be made only in the manner, provided in
title II of the Social Security Act [sections 401 to 425 of
this title] as in effect at the time of the last previous
computation or recomputation of such individual’s primary insurance amount, and as though application
therefor was filed in the month in which application for
such last previous computation or recomputation was
filed. No recomputation made under this paragraph
shall be regarded as a recomputation under section
215(f) of the Social Security Act [section 415(f) of this
title]. Any such recomputation shall be effective for
and after the twelfth month before the month in which
the application was filed, but in no case for any month
before January 1957.’’
DISPOSITION OF REMAINS OF DECEASED PERSONNEL
Recovery, care, and disposition of the remains of deceased members of the uniformed services and other deceased personnel, see section 1481 et seq. of Title 10,
Armed Forces.
BURIAL OF CERTAIN COMMISSIONED OFFICERS
Act Apr. 30, 1956, ch. 227, 70 Stat. 124, provided: ‘‘That
burial in national cemeteries of the remains of commissioned officers of the United States Public Health Service who were detailed for duty with the Army or Navy
during World War I pursuant to the act of July 1, 1902
(32 Stat. 712, 713), as amended, and Executive Order
Numbered 2571 dated April 3, 1917, and of the wife,
widow, minor child and, in the discretion of the Secretary of the Army, unmarried adult child of these officers is authorized: Provided, That the remains of the

§ 213a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

wife, widow, and children may, in the discretion of the
Secretary of the Army, be removed from a national
cemetery proper and interred in the post section of a
national cemetery if, upon death, the related officer is
not buried in the same or an adjoining gravesite.’’
DELEGATION OF AUTHORITY
Memorandum of President of the United States, Dec.
30, 1992, 58 F.R. 3485, provided:
Memorandum for the Secretary of Defense, the Secretary of Health and Human Services
The authority of the President under section 212(b) of
the Public Health Service Act (42 U.S.C. 213(b)) is hereby delegated to the Secretary of Defense. In the exercise of that authority, the Secretary of Defense shall
ensure that no military ribbon, medal, or decoration is
awarded to an officer of the Public Health Service
without the approval of the Secretary of Health and
Human Services.
The Secretary of Defense shall ensure the publication
of this memorandum in the Federal Register.
GEORGE BUSH.

§ 213a. Rights, benefits, privileges, and immunities for commissioned officers or beneficiaries; exercise of authority by Secretary
or designee
(a) Commissioned officers of the Service or
their surviving beneficiaries are entitled to all
the rights, benefits, privileges, and immunities
now or hereafter provided for commissioned officers of the Army or their surviving beneficiaries
under the following provisions of title 10:
(1) Section 1036, Escorts for dependents of
members: transportation and travel allowances.
(2) Chapter 61, Retirement or Separation for
Physical Disability, except that sections 1201,
1202, and 1203 do not apply to commissioned officers of the Public Health Service who have
been ordered to active duty for training for a
period of more than 30 days.
(3) Chapter 69, Retired Grade, except sections 1370, 1374,1 1375 and 1376(a).1
(4) Chapter 71, Computation of Retired Pay,
except formula No. 3 of section 1401.1
(5) Chapter 73, Retired Serviceman’s Family
Protection Plan; Survivor Benefit Plan.
(6) Chapter 75, Death Benefits.
(7) Section 2771, Final settlement of accounts: deceased members.
(8) Chapter 163, Military Claims, but only
when commissioned officers of the Service are
entitled to military benefits under section 213
of this title.
(9) Section 2603, Acceptance of fellowships,
scholarships, or grants.
(10) Section 2634, Motor vehicles: for members on permanent change of station.
(11) Section 1035, Deposits of Savings.
(12) Section 1552, Correction of military records: claims incident thereto.
(13) Section 1553, Review of discharge or dismissal.
(14) Section 1554, Review of retirement or
separation without pay for physical disability.
(15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
(16) Section 1052, Reimbursement for adoption expenses.
(17) Section 1059, Transitional compensation
and commissary and exchange benefits for de1 See

References in Text note below.

Page 72

pendents of members separated for dependent
abuse.
(b) The authority vested by title 10 in the
‘‘military departments’’, ‘‘the Secretary concerned’’, or ‘‘the Secretary of Defense’’ with respect to the rights, privileges, immunities, and
benefits referred to in subsection (a) of this section shall be exercised, with respect to commissioned officers of the Service, by the Secretary
of Health and Human Services or his designee.
(July 1, 1944, ch. 373, title II, § 221, as added Aug.
10, 1956, ch. 1041, § 4, 70A Stat. 619; amended Pub.
L. 85–861, § 4, Sept. 2, 1958, 72 Stat. 1547; Pub. L.
86–160, § 3, Aug. 14, 1959, 73 Stat. 359; Pub. L.
87–555, § 2, July 27, 1962, 76 Stat. 244; Pub. L.
88–132, § 5(k), Oct. 2, 1963, 77 Stat. 214; Pub. L.
88–431, § 1(d), Aug. 14, 1964, 78 Stat. 440; Pub. L.
89–538, § 3(b), Aug. 14, 1966, 80 Stat. 348; Pub. L.
92–425, § 5, Sept. 21, 1972, 86 Stat. 713; Pub. L.
96–76, title III, § 312, Sept. 29, 1979, 93 Stat. 586;
Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695; Pub. L. 96–513, title V, § 507(f)(2), Dec.
12, 1980, 94 Stat. 2920; Pub. L. 99–117, § 4, Oct. 7,
1985, 99 Stat. 492; Pub. L. 105–85, div. A, title VI,
§ 653(a), Nov. 18, 1997, 111 Stat. 1804; Pub. L.
107–107, div. A, title VI, § 653(a), Dec. 28, 2001, 115
Stat. 1153.)
REFERENCES IN TEXT
Sections 1374 and 1376(a) of title 10, referred to in subsec. (a)(3), were repealed by Pub. L. 103–337, div. A, title
XVI, § 1662(k)(2), (3)(A)(i), Oct. 5, 1994, 108 Stat. 3006. See
sections 12771 to 12774 of Title 10, Armed Forces.
Formula No. 3 of section 1401 of title 10, referred to
in subsec. (a)(4), was struck from the table set forth in
section 1401(a) of title 10 by Pub. L. 103–337, div. A, title
XVI, § 1662(j)(2), Oct. 5, 1994, 108 Stat. 3004.
CODIFICATION
Section was formerly classified to section 316 of title
37 prior to the general revision and enactment of Title
37, Pay and Allowances of the Uniformed Services, by
Pub. L. 87–649, § 1, Sept. 7, 1962, 76 Stat. 451.
AMENDMENTS
2001—Subsec. (a)(17). Pub. L. 107–107 added cl. (17).
1997—Subsec. (a)(16). Pub. L. 105–85 added cl. (16).
1985—Subsec. (a)(15). Pub. L. 99–117 added cl. (15).
1980—Subsec. (a)(3). Pub. L. 96–513 inserted reference
to section 1370 of title 10.
1979—Subsec. (a)(12) to (14). Pub. L. 96–76 added cls.
(12) to (14).
1972—Subsec. (a)(5). Pub. L. 92–425 substituted ‘‘Retired Serviceman’s Family Protection Plan; Survivor
Benefit Plan’’ for ‘‘Annuities Based on Retired or Retainer Pay’’.
1966—Subsec. (a)(11). Pub. L. 89–538 added cl. (11).
1964—Subsec. (a)(10). Pub. L. 88–431 added cl. (10).
1963—Subsec. (b). Pub. L. 88–132 inserted reference to
Secretary of Defense.
1962—Subsec. (a). Pub. L. 87–555 added cl. (9). Notwithstanding directory language that section be amended
by ‘‘adding the following new clause at the end thereof’’, the amendment was executed to subsec. (a) to reflect the probable intent of Congress since the ‘‘new’’
clause was numbered ‘‘(9)’’ and subsec. (a) contained
cls. (1) to (8).
1959—Subsec. (a). Pub. L. 86–160 added cl. (1) and renumbered former cls. (1) to (7) as (2) to (8).
1958—Subsec. (a). Pub. L. 85–861 substituted ‘‘provisions’’ for ‘‘chapters’’ in opening clause, struck out
former cl. (1) which related to chapter 55 of title 10, renumbered former cls. (2) to (6) as (1) to (5), amended cl.
(1), as renumbered, to make sections 1201 to 1203 of title
10, inapplicable to commissioned officers of the Public

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Health Service who have been ordered to active duty
for training for a period of more than 30 days, inserted
a reference to section 1374 of title 10 in cl. (2), as renumbered, struck out ‘‘Care of the Dead’’ after ‘‘Benefits’’ in cl. (5), as renumbered, and added cl. (6).
EFFECTIVE DATE OF 1997 AMENDMENT
Section 653(c) of Pub. L. 105–85 provided that: ‘‘The
amendments made by this section [amending this section and former section 857a of Title 33, Navigation and
Navigable Waters] shall apply only to adoptions that
are completed on or after the date of the enactment of
this Act [Nov. 18, 1997].’’

§ 215

ficer has previously been presented a flag under
this section or any other provision of law providing for the presentation of a United States
flag incident to release from active service for
retirement.
(c) No cost to recipient
The presentation of a flag under this section
shall be at no cost to the recipient.
(July 1, 1944, ch. 373, title II, § 213, as added Pub.
L. 106–65, div. A, title VI, § 652(b), Oct. 5, 1999, 113
Stat. 665.)

EFFECTIVE DATE OF 1980 AMENDMENT

PRIOR PROVISIONS

Amendment by Pub. L. 96–513 effective Sept. 15, 1981,
see section 701 of Pub. L. 96–513, set out as a note under
section 101 of Title 10, Armed Forces.

A prior section 214, acts July 1, 1944, ch. 373, title II,
§ 213, 58 Stat. 689; Apr. 27, 1956, ch. 211, § 2(a), 70 Stat.
116, authorized allowances for uniforms, prior to repeal
by Pub. L. 87–649, § 14b, Sept. 7, 1962, 76 Stat. 499. See
section 415 of Title 37, Pay and Allowances of the Uniformed Services.

EFFECTIVE DATE OF 1963 AMENDMENT
Amendment by Pub. L. 88–132 effective Oct. 1, 1963,
see section 14 of Pub. L. 88–132, set out as an Effective
Date note under section 201 of Title 37, Pay and Allowances of the Uniformed Services.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
RULES AND REGULATIONS; SAVINGS DEPOSIT BENEFITS
Regulations prescribed by the Secretary of Health,
Education, and Welfare [now Health and Human Services] concerning savings deposit benefits for Public
Health Service personnel to be prescribed jointly with
regulations prescribed by the Secretaries concerned
under section 1035 of Title 10, Armed Forces, see section
3(c) of Pub. L. 89–538, set out as a note under section
1035 of Title 10.
BACK PAYMENTS: VALIDATION; APPLICATION; LIMITATIONS; ACCOUNTABILITY OF DISBURSING OFFICERS;
REGULATIONS
Transportation and travel allowances to escorts for
dependents of members, see sections 4 to 7 of Pub. L.
86–160, set out as a note under section 1036 of Title 10,
Armed Forces.
DESIGNATION OF BENEFICIARY MADE BEFORE
JANUARY 1, 1956
Designation of beneficiary made before Jan. 1, 1956,
considered as the designation of a beneficiary for the
purposes of section 4 of Pub. L. 85–861, which amended
this section, see section 31 of Pub. L. 85–861, set out as
a note under section 2771 of Title 10, Armed Forces.

§ 214. Presentation of United States flag upon retirement
(a) Presentation of flag
Upon the release of an officer of the commissioned corps of the Service from active commissioned service for retirement, the Secretary of
Health and Human Services shall present a
United States flag to the officer.
(b) Multiple presentations not authorized
An officer is not eligible for presentation of a
flag under subsection (a) of this section if the of-

EFFECTIVE DATE
Section applicable with respect to releases from service described in section on or after Oct. 1, 1999, see section 652(d) of Pub. L. 106–65, set out as a note under section 12605 of Title 10, Armed Forces.

§ 214a. Repealed. Sept. 1, 1954, ch. 1211, § 5, 68
Stat. 1130
Section, act July 31, 1953, ch. 296, title II, § 204, 67
Stat. 257, related to allowances for use of taxicabs, etc.,
around duty posts. See section 408 of Title 37, Pay and
Allowances of the Uniformed Services.

§ 215. Detail of Service personnel
(a) Other Government departments
The Secretary is authorized, upon the request
of the head of an executive department, to detail
officers or employees of the Service to such department for duty as agreed upon by the Secretary and the head of such department in order
to cooperate in, or conduct work related to, the
functions of such department or of the Service.
When officers or employees are so detailed their
salaries and allowances may be paid from working funds established as provided by law or may
be paid by the Service from applicable appropriations and reimbursement may be made as
agreed upon by the Secretary and the head of
the executive department concerned. Officers
detailed for duty with the Army, Air Force,
Navy, or Coast Guard shall be subject to the
laws for the government of the service to which
detailed.
(b) State health or mental health authorities
Upon the request of any State health authority or, in the case of work relating to mental
health, any State mental health authority, personnel of the Service may be detailed by the
Surgeon General for the purpose of assisting
such State or a political subdivision thereof in
work related to the functions of the Service.
(c) Congressional committees and nonprofit educational, research, or other institutions engaged in health activities for special studies
and dissemination of information
The Surgeon General may detail personnel of
the Service to any appropriate committee of the
Congress or to nonprofit educational, research 1
1 So

in original. Probably should be followed by a comma.

§ 215

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 74

or other institutions engaged in health activities for special studies of scientific problems and
for the dissemination of information relating to
public health.
(d) Availability of funds; reimbursement by
State; detailed services deemed service for
computation of pay, promotion, etc.
Personnel detailed under subsections (b) and
(c) of this section shall be paid from applicable
appropriations of the Service, except that, in accordance with regulations such personnel may
be placed on leave without pay and paid by the
State, subdivision, or institution to which they
are detailed. In the case of detail of personnel
under subsections (b) or (c) of this section to be
paid from applicable Service appropriations, the
Secretary may condition such detail on an
agreement by the State, subdivision, or institution concerned that such State, subdivision, or
institution concerned shall reimburse the
United States for the amount of such payments
made by the Service. The services of personnel
while detailed pursuant to this section shall be
considered as having been performed in the
Service for purposes of the computation of basic
pay, promotion, retirement, compensation for
injury or death, and the benefits provided by
section 213 of this title.
(e) Commissioned Corps officers; urgent or emergency public health care needs
Except with respect to the United States
Coast Guard and the Department of Defense, and
except as provided in agreements negotiated
with officials at agencies where officers of the
Commissioned Corps may be assigned, the Secretary shall have the sole authority to deploy
any Commissioned Corps officer assigned under
this section to an entity outside of the Department of Health and Human Services for service
under the Secretary’s direction in response to
an urgent or emergency public health care need
(as defined in section 204a(a)(5) of this title).

Subsec. (d). Pub. L. 96–76, § 309(b), inserted provisions
relating to agreements by States, etc., for reimbursement upon detail of personnel.
1949—Subsec. (d). Act Oct. 12, 1949, substituted ‘‘the
computation of basic pay’’ for ‘‘longevity pay’’.
1946—Subsec. (b). Act July 3, 1946, provided for detail
of personnel on request from a State mental health authority.

(July 1, 1944, ch. 373, title II, § 214, 58 Stat. 690;
July 3, 1946, ch. 538, § 6, 60 Stat. 423; Oct. 12, 1949,
ch. 681, title V, § 521(e), 63 Stat. 835; 1953 Reorg.
Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Pub. L. 96–76, title III, § 309, Sept. 29,
1979, 93 Stat. 585; Pub. L. 109–417, title II,
§ 206(c)(1), Dec. 19, 2006, 120 Stat. 2853.)

TRANSFERS OF PERSONNEL OCCASIONED BY CREATION OF
THE ENVIRONMENTAL PROTECTION AGENCY

CODIFICATION
In subsec. (a), Air Force was inserted on the authority of section 207(a), (f) of act July 26, 1947, ch. 343, title
II, 61 Stat. 502, which established a separate Department of the Air Force, and Secretary of Defense Transfer Order No. 40 [App. A(74)], July 22, 1949, which transferred certain functions, insofar as they pertain to the
Air Force, which were not previously transferred to the
Department of the Air Force and Secretary of the Air
Force. Section 207(a), (f) of act July 26, 1947, was repealed by section 53 of act Aug. 10, 1956, ch. 1041, 70A
Stat. 641. Section 1 of act Aug. 10, 1956, enacted ‘‘Title
10, Armed Forces’’, which in sections 8010 to 8013 continued the Department of the Air Force under the administrative supervision of a Secretary of the Air
Force.
AMENDMENTS
2006—Subsec. (e). Pub. L. 109–417 added subsec. (e).
1979—Subsec. (c). Pub. L. 96–76, § 309(a), inserted provisions authorizing detail of personnel to appropriate
committees of Congress.

EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

Pub. L. 91–604, § 15(b)(1)–(8)(A), Dec. 31, 1970, 84 Stat.
1710–1712, provided that:
‘‘(1) Subject to such requirements as the Civil Service
Commission may prescribe, any commissioned officer
of the Public Health Service (other than an officer who
retires under section 211 of the Public Health Service
Act [section 212 of this title] after his election but prior
to his transfer pursuant to this paragraph and paragraph (2)) who, upon the day before the effective date
of Reorganization Plan Numbered 3 of 1970 (hereinafter
in this subsection referred to as the ‘plan’), is serving
as such officer (A) primarily in the performance of
functions transferred by such plan to the Environmental Protection Agency or its Administrator (hereinafter in this subsection referred to as the ‘Agency’
and the ‘Administrator,’ respectively), may, if such officer so elects, acquire competitive status and be transferred to a competitive position in the Agency; or (B)
primarily in the performance of functions determined
by the Secretary of Health, Education, and Welfare
(hereinafter in this subsection referred to as the ‘Secretary’) to be materially related to the functions so
transferred, may, if authorized by agreement between
the Secretary and the Administrator, and if such officer so elects, acquire such status and be so transferred.
‘‘(2) An election pursuant to paragraph (1) shall be effective only if made in accordance with such procedures as may be prescribed by the Civil Service Com-

Page 75

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mission (A) before the close of the 24th month after the
effective date of the plan [Dec. 2, 1970], or (B) in the
case of a commissioned officer who would be liable for
training and service under the Military Selective Service Act of 1967 [section 451 et seq. of Title 50, App., War
and National Defense] but for the operation of section
6(b)(3) thereof (50 U.S.C. App. 456(b)(3)), before (if it occurs later than the close of such 24th month) the close
of the 90th day after the day upon which he has completed his 24th month of service as such officer.
‘‘(3)(A) Except as provided in subparagraph (B), any
commissioned officer of the Public Health Service who,
pursuant to paragraphs (1) and (2), elects to transfer to
a position in the Agency which is subject to chapter 51
and subchapter III of chapter 53 of title 5, United States
Code (hereinafter in this subsection referred to as the
‘transferring officer’), shall receive a pay rate of the
General Schedule grade of such position which is not
less than the sum of the following amounts computed
as of the day preceding the date of such election:
‘‘(i) the basic pay, the special pay, the continuation
pay, and the subsistence and quarters allowances, to
which he is annually entitled as a commissioned officer of the Public Health Service pursuant to title 37,
United States Code;
‘‘(ii) the amount of Federal income tax, as determined by estimate of the Secretary, which the transferring officer, had he remained a commissioned officer, would have been required to pay on his subsistence and quarters allowances for the taxable year
then current if they had not been tax free;
‘‘(iii) an amount equal to the biweekly average cost
of the coverages designated ‘high option, self and
family’ under the Government-wide Federal employee
health benefits programs plans, multiplied by twenty-six; and
‘‘(iv) an amount equal to 7 per centum of the sum
of the amounts determined under clauses (i) through
(iii), inclusive.
‘‘(B) A transferring officer shall in no event receive,
pursuant to subparagraph (A), a pay rate in excess of
the maximum rate applicable under the General Schedule to the class of position, as established under chapter 51 of title 5, United States Code, to which such officer is transferred pursuant to paragraphs (1) and (2).
‘‘(4)(A) A transferring officer shall be credited, on the
day of his transfer pursuant to his election under paragraphs (1) and (2), with one hour of sick leave for each
week of active service, as defined by section 211(d) of
the Public Health Service Act [section 212(d) of this
title].
‘‘(B) The annual leave to the credit of a transferring
officer on the day before the day of his transfer, shall,
on such day of transfer, be transferred to his credit in
the Agency on an adjusted basis under regulations prescribed by the Civil Service Commission. The portion of
such leave, if any, that is in excess of the sum of (i) 240
hours, and (ii) the number of hours that have accrued
to the credit of the transferring officer during the calendar year then current and which remain unused,
shall thereafter remain to his credit until used, and
shall be reduced in the manner described by subsection
(c) of section 6304 of title 5, United States Code.
‘‘(5) A transferring officer who is required to change
his official station as a result of his transfer under this
subsection shall be paid such travel, transportation,
and related expenses and allowances, as would be provided pursuant to subchapter II of chapter 57 of title 5,
United States Code, in the case of a civilian employee
so transferred in the interest of the Government. Such
officer shall not (either at the time of such transfer or
upon a subsequent separation from the competitive
service) be deemed to have separated from, or changed
permanent station within, a uniformed service for purposes of section 404 of title 37, United States Code.
‘‘(6) Each transferring officer who prior to January 1,
1958, was insured pursuant to the Federal Employees’
Group Life Insurance Act of 1954, and who subsequently
waived such insurance, shall be entitled to become insured under chapter 87 of title 5, United States Code,

§ 216

upon his transfer to the Agency regardless of age and
insurability.
‘‘(7)(A) Effective as of the date a transferring officer
acquires competitive status as an employee of the
Agency, there shall be considered as the civilian service of such officer for all purposes of chapter 83, title 5,
United States Code, (i) his active service as defined by
section 211(d) of the Public Health Service Act [section
212(d) of this title], or (ii) any period for which he
would have been entitled, upon his retirement as a
commissioned officer of the Public Health Service, to
receive retired pay pursuant to section 211(a)(4)(B) of
such Act [section 212(a)(4)(B) of this title]; however, no
transferring officer may become entitled to benefits
under both subchapter III of such chapter and title II of
the Social Security Act [section 401 et seq. of this title]
based on service as such a commissioned officer performed after 1956, but the individual (or his survivors)
may irrevocably elect to waive benefit credit for the
service under one such law to secure credit under the
other.
‘‘(B) A transferring officer on whose behalf a deposit
is required to be made by subparagraph (C) and who,
after transfer to a competitive position in the Agency
under paragraphs (1) and (2), is separated from Federal
service or transfers to a position not covered by subchapter III of chapter 83 of title 5, United States Code,
shall not be entitled, nor shall his survivors be entitled,
to a refund of any amount deposited on his behalf in accordance with this section. In the event he transfers,
after transfer under paragraphs (1) and (2), to a position
covered by another Government staff requirement system under which credit is allowable for service with respect to which a deposit is required under subparagraph
(C), no credit shall be allowed under such subchapter III
with respect to such service.
‘‘(C) The Secretary shall deposit in the Treasury of
the United States to the credit of the Civil Service Retirement and Disability Fund, on behalf of and to the
credit of such transferring officer, an amount equal to
that which such individual would be required to deposit
in such fund to cover the years of service credited to
him for purposes of his retirement under subparagraph
(A), had such service been service as an employee as defined in section 8331(1) of title 5, United States Code.
The amount so required to be deposited with respect to
any transferring officer shall be computed on the basis
of the sum of each of the amounts described in paragraph (3)(A) which were received by, or accrued to the
benefit of, such officer during the years so credited.
The deposits which the Secretary is required to make
under this subparagraph with respect to any transferring officer shall be made within two years after the
date of his transfer as provided in paragraphs (1) and
(2), and the amounts due under this subparagraph shall
include interest computed from the period of service
credited to the date of payment in accordance with section 8334(e) of title 5, United States Code.
‘‘(8)(A) A commissioned officer of the Public Health
Service, who, upon the day before the effective date of
the plan, is on active service therewith primarily assigned to the performance of functions described in
paragraph (1)(A), shall, while he remains in active service, as defined by section 211(d) of the Public Health
Service Act [section 212(d) of this title], be assigned to
the performance of duties with the Agency, except as
the Secretary and the Administrator may jointly
otherwise provide.’’

§ 216. Regulations
(a) Prescription by President: appointments, retirement, etc.
The President shall from time to time prescribe regulations with respect to the appointment, promotion, retirement, termination of
commission, titles, pay, uniforms, allowances
(including increased allowances for foreign service), and discipline of the commissioned corps of
the Service.

§ 217

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Promulgation by Surgeon General; administration of Service
The Surgeon General, with the approval of the
Secretary, unless specifically otherwise provided, shall promulgate all other regulations
necessary to the administration of the Service,
including regulations with respect to uniforms
for employees, and regulations with respect to
the custody, use, and preservation of the
records, papers, and property of the Service.
(c) Preference to school of medicine
No regulation relating to qualifications for appointment of medical officers or employees shall
give preference to any school of medicine.
(July 1, 1944, ch. 373, title II, § 215, 58 Stat. 690;
Oct. 12, 1949, ch. 681, title V, § 521(f), 63 Stat. 835;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631.)
AMENDMENTS
1949—Subsec. (b). Act Oct. 12, 1949, struck out references to travel and transportation of household goods
and effects.
EFFECTIVE DATE OF 1949 AMENDMENT
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949,
see section 533(a) of act Oct. 12, 1949, set out as a note
under section 854a of Title 33, Navigation and Navigable
Waters.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, January 30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§ 217. Use of Service in time of war or emergency
In time of war, or of emergency proclaimed by
the President, he may utilize the Service to
such extent and in such manner as shall in his
judgment promote the public interest. In time of
war, or of emergency involving the national defense proclaimed by the President, he may by
Executive order declare the commissioned corps
of the Service to be a military service. Upon
such declaration, and during the period of such
war or such emergency or such part thereof as
the President shall prescribe, the commissioned

Page 76

corps (a) shall constitute a branch of the land
and naval forces of the United States, (b) shall,
to the extent prescribed by regulations of the
President, be subject to the Uniform Code of
Military Justice [10 U.S.C. 801 et seq.], and (c)
shall continue to operate as part of the Service
except to the extent that the President may direct as Commander in Chief.
(July 1, 1944, ch. 373, title II, § 216, 58 Stat. 690;
Apr. 27, 1956, ch. 211, § 1, 70 Stat. 116.)
REFERENCES IN TEXT
The Uniform Code of Military Justice, referred to in
text, is classified to chapter 47 (§ 801 et seq.) of Title 10,
Armed Forces.
AMENDMENTS
1956—Act Apr. 27, 1956, empowered President to declare commissioned corps of the Service to be a military service in time of emergency involving national
defense, and substituted ‘‘the Uniform Code of Military
Justice’’ for ‘‘the Articles of War and to the Articles
for the Government of the Navy’’.
REPEAL OF PRIOR ACTS CONTINUING SECTION
Section 6 of Joint Res. July 3, 1952, ch. 570, 66 Stat.
334, repealed Joint Res. Apr. 14, 1952, ch. 204, 66 Stat. 54
as amended by Joint Res. May 28, 1952, ch. 339, 66 Stat.
96; Joint Res. June 14, 1952, ch. 437, 66 Stat. 137; Joint
Res. June 30, 1952, ch. 526, 66 Stat. 296, which continued
provisions until July 3, 1952. This repeal shall take effect as of June 16, 1952, by section 7 of said Joint Res.
July 3, 1952.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
EXECUTIVE ORDER NO. 9575
Ex. Ord. No. 9575, eff. June 28, 1945, 10 F.R. 7895, which
declared the Commissioned Corps of the Public Health
Service to be a military service subject to the Articles
for the Government of the Navy as therein prescribed,
was superseded by Ex. Ord. No. 10349, eff. Apr. 28, 1952,
17 F.R. 3769.
EXECUTIVE ORDER NO. 10349
Ex. Ord. No. 10349, eff. Apr. 28, 1952, 17 F.R. 3769, superseded Ex. Ord. No. 9575, and subjected the Commissioned Corps of the Public Health Service to the provisions of the Uniform Code of Military Justice until
June 1, 1952.
EXECUTIVE ORDER NO. 10356
Ex. Ord. No. 10356, eff. June 2, 1952, 17 F.R. 4967,
amended Ex. Ord. No. 10349, and extended from June 1,
1952, to June 15, 1952, the period during which the Commissioned Corps of the Public Health Service was subject to the provisions of the Uniform Code of Military
justice.
EXECUTIVE ORDER NO. 10362
Ex. Ord. No. 10362, eff. June 14, 1952, 17 F.R. 5413,
amended Ex. Ord. No. 10356, and extended from June 15,
1952, to June 30, 1952, the period during which the Commissioned Corps of the Public Health Service was subject to the Uniform Code of Military Justice.

Page 77

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EXECUTIVE ORDER NO. 10367

Ex. Ord. No. 10367, eff. June 30, 1952, 17 F.R. 5929,
amended Ex. Ord. No. 10362, and extended from June 30,
1952, to July 3, 1952, the period during which the Commissioned Corps of the Public Health Service was subject to the Uniform Code of Military Justice.

§ 217a. Advisory councils or committees
(a) Appointment; purpose
The Secretary may, without regard to the provisions of title 5 governing appointments in the
competitive service, and without regard to the
provisions of chapter 51 and subchapter III of
chapter 53 of such title relating to classification
and General Schedule pay rates, from time to
time, appoint such advisory councils or committees (in addition to those authorized to be established under other provisions of law), for such
periods of time, as he deems desirable with such
period commencing on a date specified by the
Secretary for the purpose of advising him in
connection with any of his functions.
(b) Compensation and allowances of members
not full-time employees of United States
Members of any advisory council or committee appointed under this section who are not
regular full-time employees of the United States
shall, while attending meetings or conferences
of such council or committee or otherwise engaged on business of such council or committee
receive compensation and allowances as provided in section 210(c) of this title for members
of national advisory councils established under
this chapter.
(c) Delegation of functions
Upon appointment of any such council or committee, the Secretary may delegate to such
council or committee such advisory functions
relating to grants-in-aid for research or training
projects or programs, in the areas or fields with
which such council or committee is concerned,
as the Secretary determines to be appropriate.
(July 1, 1944, ch. 373, title II, § 222, as added Pub.
L. 87–838, § 3, Oct. 17, 1962, 76 Stat. 1073; amended
Pub. L. 91–515, title VI, § 601(a)(3), (c), Oct. 30,
1970, 84 Stat. 1310, 1311; Pub. L. 99–158, § 3(a)(4),
Nov. 20, 1985, 99 Stat. 879.)
REFERENCES IN TEXT
The General Schedule, referred to in subsec. (a), is set
out under section 5332 of Title 5.
AMENDMENTS
1985—Subsec. (c). Pub. L. 99–158 amended subsec. (c)
generally. Prior to amendment, subsec. (c) read as follows: ‘‘Upon appointment of any such council or committee, the Surgeon General, with the approval of the
Secretary, may transfer such of the functions of the
National Advisory Health Council relating to grants-inaid for research or training projects or programs in the
areas or fields with which such council or committee is
concerned as he determines to be appropriate.’’
1970—Subsec. (a). Pub. L. 91–515, § 601(c)(1), substituted provisions authorizing the Secretary to appoint advisory councils or committees without regard
to specified provisions governing appointments in the
competitive service and relating to classification and
General Schedule pay rates, for provisions authorizing
the Surgeon General to appoint advisory committees
without regard to the civil service laws and subject to
the Secretary’s approval in such cases as he prescribed.

§ 217a–1

Subsec. (b). Pub. L. 91–515, § 601(a)(3), inserted ‘‘council or’’ before ‘‘committee’’ wherever appearing.
Subsec. (c). Pub. L. 91–515, § 601(a)(3), (c)(2), inserted
‘‘council or’’ before ‘‘committee’’ wherever appearing,
and ‘‘or programs’’ after ‘‘projects’’.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
TERMINATION OF ADVISORY COMMITTEES; REPORT BY
SECRETARY TO CONGRESSIONAL COMMITTEES RELATING TO TERMINATION
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, provided
that:
‘‘(a) An advisory committee established by or pursuant to the Public Health Service Act [section 201 et seq.
of this title], the Mental Retardation Facilities and
Community Mental Health Centers Construction Act of
1963 [sections 2689 et seq. and 6001 et seq. of this title],
or the Comprehensive Alcohol Abuse and Alcoholism
Prevention, Treatment, and Rehabilitation Act of 1970
[section 4541 et seq. of this title] shall terminate at
such time as may be specifically prescribed by an Act
of Congress enacted after the date of the enactment of
this Act [Jan. 4, 1975].
‘‘(b) The Secretary of Health, Education, and Welfare
shall report, within one year after the date of the enactment of the Act [Jan. 4, 1975], to the Committee on
Labor and Public Welfare of the Senate and the Committee on Interstate and Foreign Commerce of the
House of Representatives (1) the purpose and use of
each advisory committee established by or pursuant to
the Public Health Service Act, the Mental Retardation
Facilities and Community Mental Health Centers Construction Act of 1963, or the Comprehensive Alcohol
Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 and (2) his recommendations respecting the termination of each such advisory committee.’’

§ 217a–1. Advisory committees; prohibition of
consideration of political affiliations
All appointments to advisory committees established to assist in implementing the Public
Health Service Act [42 U.S.C. 201 et seq.],1 and
the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation
Act of 1970 [42 U.S.C. 4541 et seq.], shall be made
without regard to political affiliation.
(Pub. L. 94–278, title X, § 1001, Apr. 22, 1976, 90
Stat. 415; Pub. L. 111–256, § 2(e), Oct. 5, 2010, 124
Stat. 2643.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in text, is
act July 1, 1944, ch. 373, 58 Stat. 682, which is classified
generally to this chapter (§ 201 et seq.). For complete
classification of this Act to the Code, see Short Title
note set out under section 201 of this title and Tables.
The Comprehensive Alcohol Abuse and Alcoholism
Prevention, Treatment, and Rehabilitation Act of 1970,
referred to in text, is Pub. L. 91–616, Dec. 31, 1970, 84
Stat. 1848, as amended, which is classified principally
to chapter 60 (§ 4541 et seq.) of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 4541 of this title and Tables.
1 So

in original. The comma probably should not appear.

§ 217b

TITLE 42—THE PUBLIC HEALTH AND WELFARE
CODIFICATION

Section was not enacted as a part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Pub. L. 111–256 struck out ‘‘the Mental Retardation Facilities and Community Mental Health Centers
Construction Act of 1963,’’ after ‘‘Public Health Service
Act,’’.

§ 217b. Volunteer services
Subject to regulations, volunteer and uncompensated services may be accepted by the Secretary, or by any other officer or employee of
the Department of Health and Human Services
designated by him, for use in the operation of
any health care facility or in the provision of
health care.
(July 1, 1944, ch. 373, title II, § 223, as added Pub.
L. 90–174, § 6, Dec. 5, 1967, 81 Stat. 539; amended
Pub. L. 103–43, title XX, § 2008(h), June 10, 1993,
107 Stat. 212.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘Health and Human
Services’’ for ‘‘Health, Education, and Welfare’’.

§ 218. National Advisory Councils on Migrant
Health
(a) Appointment; duties
Within 120 days of July 29, 1975, the Secretary
shall appoint and organize a National Advisory
Council on Migrant Health (hereinafter in this
subsection referred to as the ‘‘Council’’) which
shall advise, consult with, and make recommendations to, the Secretary on matters concerning the organization, operation, selection,
and funding of migrant health centers and other
entities under grants and contracts under section 254b 1 of this title.
(b) Membership
The Council shall consist of fifteen members,
at least twelve of whom shall be members of the
governing boards of migrant health centers or
other entities assisted under section 254b 1 of
this title. Of such twelve members who are
members of such governing boards, at least nine
shall be chosen from among those members of
such governing boards who are being served by
such centers or grantees and who are familiar
with the delivery of health care to migratory
agricultural workers and seasonal agricultural
workers. The remaining three Council members
shall be individuals qualified by training and experience in the medical sciences or in the administration of health programs.
(c) Terms of office
Each member of the Council shall hold office
for a term of four years, except that (1) any
member appointed to fill a vacancy occurring
prior to the expiration of the term for which his
predecessor was appointed shall be appointed for
the remainder of such term; and (2) the terms of
the members first taking office after July 29,
1975, shall expire as follows: four shall expire
four years after such date, four shall expire
three years after such date, four shall expire two
1 See

References in Text note below.

Page 78

years after such date, and three shall expire one
year after such date, as designated by the Secretary at the time of appointment.
(d) Applicability of section 14(a) of Federal Advisory Committee Act
Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
(July 1, 1944, ch. 373, title II, § 217, 58 Stat. 691;
July 3, 1946, ch. 538, § 5(b)–(d), 60 Stat. 422; June
16, 1948, ch. 481, §§ 4(a)–(c), 6(b), 62 Stat. 467, 469;
June 24, 1948, ch. 621, § 4(a)–(c), 62 Stat. 600; Aug.
15, 1950, ch. 714, § 3(a)–(d), 64 Stat. 446; 1953 Reorg.
Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Pub. L. 91–515, title VI, § 601(a)(1),
Oct. 30, 1970, 84 Stat. 1310; Pub. L. 91–616, title
IV, § 401, Dec. 31, 1970, 84 Stat. 1853; Pub. L.
92–157, title III, § 301(b), Nov. 18, 1971, 85 Stat. 463;
Pub. L. 92–218, § 6(a)(1), Dec. 23, 1971, 85 Stat. 785;
Pub. L. 92–255, title V, § 502(a), Mar. 21, 1972, 86
Stat. 85; Pub. L. 92–423, § 7(a), Sept. 19, 1972, 86
Stat. 687; Pub. L. 93–348, title II, § 211(a), July 12,
1974, 88 Stat. 351; Pub. L. 94–63, title IV, § 401(b),
July 29, 1975, 89 Stat. 341; Pub. L. 94–371, § 9, July
26, 1976, 90 Stat. 1040; Pub. L. 95–622, title III,
§ 302(b), Nov. 9, 1978, 92 Stat. 3442; Pub. L. 95–626,
title I, § 102(b)(1), Nov. 10, 1978, 92 Stat. 3551; Pub.
L. 96–180, § 13, Jan. 2, 1980, 93 Stat. 1304; Pub. L.
96–181, § 14, Jan. 2, 1980, 93 Stat. 1315; Pub. L.
98–24, § 2(a)(2), Apr. 26, 1983, 97 Stat. 176; Pub. L.
98–509, title III, § 302, Oct. 19, 1984, 98 Stat. 2364;
Pub. L. 99–158, § 3(a)(2), (3), Nov. 20, 1985, 99 Stat.
878, 879; Pub. L. 99–570, title IV, § 4004(c), Oct. 27,
1986, 100 Stat. 3207–111; Pub. L. 99–660, title III,
§ 311(b)(1), Nov. 14, 1986, 100 Stat. 3779.)
REFERENCES IN TEXT
Section 254b of this title, referred to in subsecs. (a)
and (b), was in the original a reference to section 329,
meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§ 254b et
seq.) of part D of subchapter II of this chapter by Pub.
L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Section 2 of
Pub. L. 104–299 enacted a new section 330 of act July 1,
1944, which is classified to section 254b of this title.
Section 14(a) of the Federal Advisory Committee Act,
referred to in subsec. (d), is section 14(a) of Pub. L.
92–463, as amended, which is set out in the Appendix to
Title 5, Government Organization and Employees.
AMENDMENTS
1986—Pub. L. 99–570 redesignated former subsec. (e)(1)
to (4) as subsecs. (a) to (d), respectively, in subsec. (c),
further redesignated former cls. (A) and (B) as (1) and
(2), respectively, and struck out former subsecs. (a) to
(d), which related, respectively, to composition, qualifications, appointment and tenure of the National Advisory Mental Health Council and the National Advisory Council on Alcohol Abuse and Alcoholism; duties
of the National Advisory Mental Health Council; duties
of the National Advisory Council on Alcohol Abuse and
Alcoholism; and the composition, qualifications, and
duties of the National Advisory Council on Drug Abuse.
Subsec. (c). Pub. L. 99–660 which directed that ‘‘section 300cc of this title’’ be substituted for ‘‘section
300aa of this title’’ could not be executed because the
reference in question appeared in former subsec. (c)
which was repealed by Pub. L. 99–570.
1985—Subsec. (a). Pub. L. 99–158, § 3(a)(2)(A), in first
sentence substituted ‘‘National Advisory Mental
Health Council and the National Advisory Council on
Alcohol Abuse and Alcoholism’’ for ‘‘National Advisory
Health Council, the National Advisory Mental Health
Council, the National Advisory Council on Alcohol
Abuse and Alcoholism, and the National Advisory Den-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tal Research Council’’, and substituted ‘‘by the Secretary’’ for ‘‘by the Surgeon General with the approval
of the Secretary of Health, Education, and Welfare’’.
Pub. L. 99–158, § 3(a)(2)(B)(i), in second sentence
struck out ‘‘in the case of the National Advisory
Health Council, are skilled in the sciences related to
health, and’’ after ‘‘scientific authorities who,’’.
Pub. L. 99–158, § 3(a)(2)(B)(ii), which directed the substitution in second sentence of ‘‘the National Advisory
Mental Health Council and the National Advisory
Council on Alcohol Abuse and Alcoholism’’ for ‘‘the National Advisory Mental Health Council, the National
Advisory Council on Alcohol Abuse and Alcoholism, the
National Advisory Heart Council, and the National Advisory Dental Research Council’’ was executed by making the substitution for ‘‘the National Advisory Mental
Health Council, the National Advisory Council on Alcohol Abuse and Alcoholism, and the National Advisory
Dental Research Council’’ as the probable intent of
Congress in view of the prior deletion of ‘‘the National
Advisory Heart Council,’’ by Pub. L. 92–423. See 1972
Amendment note below.
Pub. L. 99–158, § 3(a)(2)(B)(iii), in second sentence substituted ‘‘and alcohol abuse and alcoholism’’ for
‘‘, alcohol abuse and alcoholism, and dental diseases
and conditions’’.
Pub. L. 99–158, § 3(a)(2)(C), struck out third sentence
which provided that in the case of the National Advisory Dental Research Council, four of the six members
selected from among the leading medical or scientific
authorities be dentists.
Subsec. (b). Pub. L. 99–158, § 3(a)(3), redesignated subsec. (c) as (b) and struck out former subsec. (b) which
related to the duties of the National Advisory Health
Council.
Subsecs. (c) to (e), (g). Pub. L. 99–158, § 3(a)(3), redesignated subsecs. (d), (e), and (g) as (c), (d), and (e), respectively.
1984—Subsec. (a). Pub. L. 98–509 inserted provision requiring the Secretary to assure that the membership of
the National Advisory Council on Alcohol Abuse and
Alcoholism is broadly representative of experts in the
fields of prevention, research, and treatment of alcohol
abuse, alcoholism, and rehabilitation of alcohol abusers.
1983—Subsecs. (c), (d). Pub. L. 98–24 substituted ‘‘section 300aa of this title’’ for ‘‘section 219 of this title’’.
1980—Subsec. (a). Pub. L. 96–180 authorized appointees
to serve after the expiration of their terms until their
successors have taken office.
Subsec. (e)(1). Pub. L. 96–181, in provisions relating to
the eligibility for selection of members, inserted officers or employees of State and local drug abuse agencies, and inserted provision that appointed members
may serve after the expiration of their terms until
their successors have taken office.
1978—Subsec. (f). Pub. L. 95–622 struck out subsec. (f)
which related to the establishment of a National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research.
Subsec. (g)(1), (2). Pub. L. 95–626 substituted ‘‘section
254b’’ for ‘‘section 247d’’.
1976—Subsec. (d). Pub. L. 94–371 inserted provision
that the Council advise the Secretary regarding policies and priorities with respect to grants and contracts
in the field of alcohol abuse and alcoholism.
1975—Subsec. (g). Pub. L. 94–63 added subsec. (g).
1974—Subsec. (f). Pub. L. 93–348 added subsec. (f).
1972—Subsec. (a). Pub. L. 92–423, § 7(a)(1), (2), struck
out ‘‘the National Advisory Heart Council,’’ after ‘‘the
National Advisory Council on Alcohol Abuse and Alcoholism’’ in two places and ‘‘heart diseases,’’ after ‘‘alcohol abuse and alcoholism,’’, respectively.
Subsec. (b). Pub. L. 92–423, § 7(a)(2), struck out
‘‘heart,’’ after ‘‘alcohol abuse and alcoholism,’’.
Subsec. (e). Pub. L. 92–255 added subsec. (e).
1971—Subsec. (a). Pub. L. 92–218, § 6(a)(1)(A), (B),
struck out reference to National Advisory Cancer
Council before National Advisory Mental Health Council in two places and struck out ‘‘cancer,’’ before ‘‘psychiatric disorders’’.

§ 218

Pub. L. 92–157 substituted ‘‘National Advisory Council on Alcohol Abuse and Alcoholism’’ for ‘‘National
Advisory Council on Alcoholic Abuse and Alcoholism’’
in second sentence.
Subsec. (b). Pub. L. 92–218, § 6(a)(1)(B), struck out
‘‘cancer,’’ before ‘‘mental health’’ in listing of various
diseases.
1970—Subsec. (a). Pub. L. 91–616, § 401(a), made subsection applicable to National Advisory Council on Alcohol Abuse and Alcoholism, and inserted alcohol abuse
and alcoholism to enumeration of diseases concerning
which members of such Council must be skilled, and
prescribed manner in which terms of members of Council would expire.
Subsec. (b). Pub. L. 91–616, § 401(b), inserted reference
to National Advisory Council on Alcohol Abuse and Alcoholism authorizing the Surgeon General to utilize
the services of members of such Council for additional
periods.
Pub. L. 91–515 inserted ‘‘or committees’’ after ‘‘councils’’.
Subsec. (d). Pub. L. 91–616, § 401(c), added subsec. (d).
1950—Act Aug. 15, 1950, § 3(d), amended section catchline to reflect addition of new advisory councils.
Subsec. (a). Act Aug. 15, 1950, § 3(a), applied provisions
to all of the advisory councils with regard to composition, qualifications, and appointment and tenure of
members.
Subsec. (b). Act Aug. 15, 1950, § 3(b), made subsection
also applicable to new advisory councils.
Subsec. (c). Act Aug. 15, 1950, § 3(c), redesignated subsec. (e) as (c) and repealed former subsec. (c).
Subsecs. (d), (f), (g). Act. Aug. 15, 1950, § 3(c), repealed
subsecs. (d), (f), and (g).
1948—Acts June 16, 1948, § 4(c), and June 24, 1948, § 4(c),
included in section catchline the National Advisory
Heart and Dental Research Councils, respectively.
Subsec. (a). Act June 16, 1948, § 6(b), substituted ‘‘National Institutes of Health’’ for ‘‘National Institute of
Health’’ in second sentence.
Subsec. (b). Acts June 16, 1948, § 4(b), and June 24,
1948, § 4(b), made subsection applicable to the National
Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (f). Act June 16, 1948, § 4(a), added subsec. (f)
which established the National Advisory Heart Council.
Subsec. (g). Act June 24, 1948, § 4(a), added subsec. (g)
which established the National Advisory Dental Research Council.
1946—Act July 3, 1946, inserted ‘‘Mental Health’’ in
section catchline.
Subsec. (b). Act July 3, 1946, inserted ‘‘or of the National Advisory Mental Health Council’’.
Subsecs. (d), (e). Act July 3, 1946, added subsecs. (d)
and (e).
EFFECTIVE DATE OF 1978 AMENDMENT
Section 302(b) of Pub. L. 95–622 provided that the
amendment made by that section is effective Nov. 1,
1978.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by Pub. L. 94–63 effective July 1, 1975, see
section 608 of Pub. L. 94–63, set out as a note under section 247b of this title.
EFFECTIVE DATE OF 1974 AMENDMENT
Section 211(b) of Pub. L. 93–348, as amended by Pub.
L. 94–278, title III, § 301(b), Apr. 22, 1976, 90 Stat. 407;
Pub. L. 94–573, § 18(b), Oct. 21, 1976, 90 Stat. 2720; Pub. L.
95–203, § 5(b), Nov. 23, 1977, 91 Stat. 1454, provided that:
‘‘The amendment made by subsection (a) [amending
this section] shall take effect November 1, 1978.’’
EFFECTIVE DATE OF 1972 AMENDMENT
Section 9 of Pub. L. 92–423 provided that: ‘‘This Act
and the amendments made by this Act [see Short Title
of 1972 Amendment note under section 201 of this title]
shall take effect sixty days after the date of enactment

§ 218a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of this Act [Sept. 19, 1972] or on such prior date after
the date of enactment of this Act as the President shall
prescribe and publish in the Federal Register.’’
EFFECTIVE DATE OF 1971 AMENDMENT
Section 7 of Pub. L. 92–218 provided that:
‘‘(a) This Act and the amendments made by this Act
[enacting sections 286a to 286g and 289l of this title,
amending this section and sections 241, 282, 283, and 284
of this title, and enacting provisions set out as notes
under sections 281 and 286 of this title] shall take effect
sixty days after the date of enactment of this Act [Dec.
23, 1971] or on such prior date after the date of enactment of this Act as the President shall prescribe and
publish in the Federal Register.
‘‘(b) The first sentence of section 454 of the Public
Health Service Act [section 289l of this title] (added by
section 5 of this Act) shall apply only with respect to
appointments made after the effective date of this Act
(as prescribed by subsection (a)).
‘‘(c) Notwithstanding the provisions of subsection (a),
members of the National Cancer Advisory Board (authorized under section 410B of the Public Health Service Act, as added by this Act) [section 286f of this title]
may be appointed, in the manner provided for in such
section, at any time after the date of enactment of this
Act [Dec. 23, 1971]. Such officers shall be compensated
from the date they first take office, at the rates provided for in such section 410B [section 286f of this
title].’’
EFFECTIVE DATE OF 1950 AMENDMENT
Section 3(a), (c) of act Aug. 15, 1950, provided that the
amendments and repeals made by that section are effective Oct. 1, 1950.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
For transfer of certain membership functions, insofar
as they pertain to the Air Force, which functions were
not previously transferred from Secretary of the Army
to Secretary of the Air Force and from Department of
the Army to Department of the Air Force, see Secretary of Defense Transfer Order No. 40 [App. C(7)],
July 22, 1949.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
EXPIRATION OF TERMS OF OFFICE ON
SEPTEMBER 30, 1950
Section 3(c) of act Aug. 15, 1950, provided in part that
terms of office as members of national advisory coun-

Page 80

cils pursuant to this section subsisting on Sept. 30, 1950,
shall expire at the close of business on such day.
TERMINATION OF NATIONAL ADVISORY HEALTH COUNCIL
Section 3(a)(1) of Pub. L. 99–158 provided that: ‘‘The
National Advisory Health Council established under
section 217 [this section] is terminated.’’
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 218a. Training of officers
(a) In general
Appropriations available for the pay and allowances of commissioned officers of the Service
shall also be available for the pay and allowances of any such officer on active duty while
attending any Federal or non-Federal educational institution or training program and,
subject to regulations of the President and to
the limitation prescribed in such appropriations,
for payment of his tuition, fees, and other necessary expenses incident to such attendance.
(b) Voluntary separation within period subsequent to attendance
Any officer whose tuition, fees, and other necessary expenses are paid pursuant to subsection
(a) of this section while attending an educational institution or training program for a
period in excess of thirty days shall be obligated
to pay to the Service an amount equal to two
times the total amount of such tuition, fees, and
other necessary expenses received by such officer during such period, and two times the total
amount of any compensation received by, and
any allowance paid to, such officer during such
period, if after return to active service such officer voluntarily leaves the Service within (1) six
months, or (2) twice the period of such attendance, whichever is greater. Such subsequent period of service shall commence upon the cessation of such attendance and of any further
continuous period of training duty for which no
tuition and fees are paid by the Service and
which is part of the officer’s prescribed formal
training program, whether such further training
is at a Service facility or otherwise. The Surgeon General may waive, in whole or in part,
any payment which may be required by this subsection upon a determination that such payment
would be inequitable or would not be in the public interest.
(c) Training in leave without pay status
A commissioned officer may be placed in leave
without pay status while attending an educational institution or training program whenever the Secretary determines that such status
is in the best interest of the Service. For purposes of computation of basic pay, promotion,
retirement, compensation for injury or death,
and the benefits provided by sections 213 and 233
of this title, an officer in such status pursuant
to the preceding sentence shall be considered as
performing service in the Service and shall have
an active service obligation as set forth in subsection (b) of this section.

Page 81

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title II, § 218, as added Feb.
28, 1948, ch. 83, § 8, 62 Stat. 47; amended Apr. 27,
1956, ch. 211, § 6, 70 Stat. 117; Pub. L. 96–76, title
III, § 310, Sept. 29, 1979, 93 Stat. 585; Pub. L.
105–392, title IV, § 402(b), Nov. 13, 1998, 112 Stat.
3588.)
AMENDMENTS
1998—Subsec. (c). Pub. L. 105–392 added subsec. (c).
1979—Subsec. (b). Pub. L. 96–76 substituted provisions
relating to payment by an officer to the Service upon
voluntary separation of two times the total amount of
tuition, fees, and other necessary expenses received by
such officer and two times the total amount of any
compensation received by, and any allowance paid to,
such officer, for provisions relating to reimbursement
by the officer to the Service upon voluntary separation
of tuition and fees and in last sentence substituted
‘‘payment’’ for ‘‘reimbursement’’ wherever appearing.
1956—Subsec. (a). Act Apr. 27, 1956, § 6(a), authorized
training of all officers of the Service, and substituted
‘‘any Federal or non-Federal educational institution or
training program’’ for ‘‘any educational institution’’.
Subsec. (b). Act Apr. 27, 1956, § 6(b), required reimbursement of tuition and fees by officers who receive
training in excess of 30 days and who voluntarily leave
the Service within a period of time which is equal to
twice the period of such training, with a minimum period of six months of service, and a maximum period of
two years, and permitted the Surgeon General to waive
any reimbursement.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.
30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§§ 219 to 224. Transferred
CODIFICATION
Section 219, acts July 1, 1944, ch. 373, title V, § 501, 58
Stat. 709; July 3, 1946, ch. 538, § 10, 60 Stat. 425; June 16,
1948, ch. 481, § 6(b), 62 Stat. 469; 1953 Reorg. Plan No. 1,
§§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 15,
1968, Pub. L. 90–574, title V, § 503(b), 82 Stat. 1012; Oct.
17, 1979, Pub. L. 96–88, title V, § 509(b), 93 Stat. 695,
which related to gifts for the benefit of the Service, was
successively renumbered by subsequent acts and transferred, see section 238 of this title.
Section 220, act July 1, 1944, ch. 373, title V, § 502, 58
Stat. 710, which related to use of immigration station
hospitals, was successively renumbered by subsequent
acts and transferred, see section 238a of this title.
Section 221, act July 1, 1944, ch. 373, title V, § 503, 58
Stat. 710, which related to disposition of money collected for care of patients, was successively renumbered by subsequent acts and transferred, see section
238b of this title.
Section 222, acts July 1, 1944, ch. 373, title V, § 504, 58
Stat. 710, June 25, 1948, ch. 654, § 6, 62 Stat. 1018; 1953
Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631, which related to care of Service patients at
Saint Elizabeths Hospital, was renumbered section 2104
of act July 1, 1944, by Pub. L. 98–24 and transferred to

§ 227a

section 300aa–3 of this title, renumbered section 2304 of
act July 1, 1944, by Pub. L. 99–660 and transferred to
section 300cc–3 of this title, and was repealed by Pub.
L. 98–621, § 10(s), Nov. 8, 1984, 98 Stat. 3381.
Section 223, act July 1, 1944, ch. 373, title V, § 505, 58
Stat. 710; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631, which related to settlement of
claims, was renumbered section 2105 of act July 1, 1944,
by Pub. L. 98–24 and transferred to section 300aa–4 of
this title, and was repealed by Pub. L. 99–117, § 12(f),
Oct. 7, 1985, 99 Stat. 495. See section 300cc–4 of this title.
Section 224, acts July 1, 1944, ch. 373, title V, § 506, 58
Stat. 710; July 15, 1954, ch. 507, § 14(b), 68 Stat. 481, which
related to transportation of remains of officers, was
successively renumbered by subsequent acts and transferred, see section 238c of this title.
A new title V (§ 501 et seq.) of the Public Health Service Act was added by Pub. L. 98–24, § 2(b), Apr. 26, 1983,
97 Stat. 177, and is classified to subchapter III–A (§ 290aa
et seq. of this title).

§ 225. Repealed. July 12, 1955, ch. 328, § 5(4), 69
Stat. 296
Section, acts July 1, 1944, ch. 373, title V, § 507, 58
Stat. 711; Feb. 25, 1946, ch. 35, § 2, 60 Stat. 30, provided
for settlement of accounts of deceased officers. See section 2771 of Title 10, Armed Forces, and section 714 of
Title 32, National Guard.
EFFECTIVE DATE OF REPEAL
Repeal effective as of effective date of payment provisions of sections 361 to 365 of former Title 37, Pay and
Allowances, except with respect to the deaths of members, see section 5 of act July 12, 1955.

§§ 225a to 227. Transferred
CODIFICATION
Section 225a, act July 1, 1944, ch. 373, title V, § 507, as
added June 24, 1967, Pub. L. 90–31, § 5, 81 Stat. 79; amended Oct. 27, 1970, Pub. L. 91–513, title I, § 3(c), 84 Stat.
1241; Apr. 22, 1976, Pub. L. 94–278, title XI, § 1102(b), 90
Stat. 415; Oct. 7, 1980, Pub. L. 96–398, title VIII, § 804(b),
94 Stat. 1603; Aug. 13, 1981, Pub. L. 97–35, title IX,
§ 902(g)(2), 95 Stat. 560, which related to availability of
appropriations for grants to Federal institutions, was
successively renumbered by subsequent acts and transferred, see section 238d of this title.
A prior section 507 of act July 1, 1944, ch. 373, title V,
providing for settlement of accounts of deceased officers, was classified to section 225 of this title and subsequently repealed.
Section 226, act July 1, 1944, ch. 373, title V, § 508, 58
Stat. 711; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631; 1970 Reorg. Plan No. 2, § 102,
eff. July 1, 1970, 35 F.R. 7959, 84 Stat. 2085, which related
to transfer of funds between appropriations, was successively renumbered by subsequent acts and transferred, see section 238e of this title.
Section 227, acts July 1, 1944, ch. 373, title V, § 509 58
Stat. 711; June 16, 1948, ch. 481, § 6(b), 62 Stat. 469; June
25, 1948, ch. 654, § 7, 62 Stat. 1018; Reorg. Plan No. 1 of
1953 §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631,
which related to availability of appropriations for carrying out purposes of this chapter, was successively renumbered by subsequent acts and transferred, see section 238f of this title.

§ 227a. Omitted
CODIFICATION
Section, Pub. L. 90–132, title II, § 204, Nov. 8, 1967, 81
Stat. 407, which provided that appropriations to the
Public Health Service be available for research grants
to hospitals of the Service, the Bureau of Prisons, Department of Justice, and to Saint Elizabeths Hospital,
on the same terms and conditions as grants to non-Federal institutions, was enacted as part of the Depart-

§§ 228 to 229d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment of Health, Education, and Welfare Appropriation
Act, 1968, and not as part of the Public Health Service
Act which comprises this chapter, and was not repeated
in subsequent appropriation acts. See section 300cc–6 of
this title. Similar provisions were contained in the following prior appropriation acts:
Pub. L. 89–787, title II, § 204, Nov. 7, 1966, 80 Stat. 1400.
Pub. L. 89–156, title II, § 204, Aug. 31, 1965, 79 Stat. 609.
Pub. L. 88–605, title II, § 204, Sept. 19, 1964, 78 Stat. 979.
Pub. L. 88–136, title II, § 204, Oct. 11, 1963, 77 Stat. 244.
Pub. L. 87–582, title II, § 204, Aug. 14, 1962, 76 Stat. 379.
Pub. L. 87–290, title II, § 206, Sept. 22, 1961, 75 Stat. 608.
Pub. L. 86–703, title II, § 207, Sept. 2, 1960, 74 Stat. 773.
Pub. L. 86–158, title II, § 210, Aug. 14, 1959, 73 Stat. 355.

§§ 228 to 229d. Transferred
CODIFICATION
Section 228, acts July 1, 1944, ch. 373, title V, § 510, 58
Stat. 711; June 25, 1948, ch. 645, § 5, 62 Stat. 859, which
related to wearing of uniforms, was successively renumbered by subsequent acts and transferred, see section 238g of this title.
Section 229, act July 1, 1944, ch. 373, title V, § 511, 58
Stat. 711; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631, which related to an annual report by Surgeon General, was successively renumbered
by subsequent acts and transferred, see section 238h of
this title.
Section 229a, act July 1, 1944, ch. 373, title V, § 512, as
added Oct. 15, 1968, Pub. L. 90–574, title V, § 503(a), 82
Stat. 1012, which related to memorials and other acknowledgments for contributions to health of the Nation, was successively renumbered by subsequent acts
and transferred, see section 238i of this title.
Section 229b, act July 1, 1944, ch. 373, title V, § 513, as
added June 30, 1970, Pub. L. 91–296, title IV, § 401(a), 84
Stat. 351; amended Oct. 7, 1980, Pub. L. 96–398, title VIII,
§ 804(c), 94 Stat. 1608; Aug. 13, 1981, Pub. L. 97–35, title
IX, § 902(g)(3), 95 Stat. 560, which related to evaluation
of programs, was successively renumbered by subsequent acts and transferred, see section 238j of this title.
Section 229c, act July 1, 1944, ch. 373, title V, § 514, as
added Nov. 9, 1978, Pub. L. 95–623, § 11(e), 92 Stat. 3456,
which related to contract authority of Secretary, was
successively renumbered by subsequent acts and transferred, see section 238k of this title.
Section 229d, act July 1, 1944, ch. 373, title V, § 515,
formerly Pub. L. 88–164, title II, § 225, as added Pub. L.
94–63, title III, § 303, July 29, 1975, 89 Stat. 326; amended
Pub. L. 95–622, title I, § 110(c), Nov. 9, 1978, 92 Stat. 3420;
renumbered and amended Pub. L. 97–35, title IX,
§ 902(e)(2)(A), Aug. 13, 1981, 95 Stat. 560, which related to
recovery of payments, was successively renumbered by
subsequent acts and transferred, see section 238l of this
title.

§ 230. Repealed. Apr. 27, 1956, ch. 211, § 5(e), 70
Stat. 117
Section, act July 1, 1944, ch. 373, title VII, § 706, formerly title VI, § 606, 58 Stat. 713; renumbered title VII,
§ 706, Aug. 13, 1946, ch. 958, § 5, 60 Stat. 1049; amended
Feb. 28, 1948, ch. 83, § 9(a), 62 Stat. 47; Oct. 12, 1949, ch.
681, title V, § 521(g), 63 Stat. 835, provided for computation of retired pay. See section 212 of this title.

§ 231. Service and supply fund; uses; reimbursement
A service and supply fund of $250,000 is established, without fiscal year limitation, for the
payment of salaries, travel, and other expenses
necessary to the maintenance and operation of
(1) a supply service for the purchase, storage,
handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and
blank forms, for which stocks may be maintained to meet, in whole or in part, require-

Page 82

ments of the Public Health Service and requisitions of other Government Offices, and (2)
such other services as the Surgeon General, with
the approval of the Secretary of Health and
Human Services, determines may be performed
more advantageously as central services; said
fund to be reimbursed from applicable appropriations or funds available when services are
performed or stock furnished, or in advance, on
a basis of rates which shall include estimated or
actual charges for personal services, materials,
equipment (including maintenance, repairs, and
depreciation), and other expenses.
(July 3, 1945, ch. 263, title II, 59 Stat. 370; 1953
Reorg. Plan No. 1, §§ 5, 8 eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Pub. L. 96–88, title V, § 509(b),
Oct. 17, 1979, 93 Stat. 695; Pub. L. 97–414, § 9(i),
Jan. 4, 1983, 96 Stat. 2064.)
CODIFICATION
Section is from the Federal Security Appropriation
Act, 1946, act July 3, 1945, and was not enacted as part
of the Public Health Service Act which comprises this
chapter.
AMENDMENTS
1983—Pub. L. 97–414 inserted ‘‘, or in advance,’’ after
‘‘stock furnished’’.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 232. National Institute of Mental Health; authorization of appropriation; construction;
location
There is authorized to be appropriated a sum
not to exceed $7,500,000 for the erection and
equipment, for the use of the Public Health
Service in carrying out the provisions of this
Act, of suitable and adequate hospital buildings
and facilities, including necessary living quarters for personnel, and of suitable and adequate
laboratory buildings and facilities, and such
buildings and facilities shall be known as the
National Institute of Mental Health. The Administrator of General Services is authorized to
acquire, by purchase, condemnation, donation,
or otherwise, a suitable and adequate site or
sites, selected on the advice of the Surgeon General of the Public Health Service, in or near the
District of Columbia for such buildings and fa-

Page 83

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cilities, and to erect thereon, furnish, and equip
such buildings and facilities. The amount authorized to be appropriated in this section shall
include the cost of preparation of drawings and
specifications, supervision of construction, and
other administrative expenses incident to the
work: Provided, That the Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction.
(July 3, 1946, ch. 538, § 11, 60 Stat. 425; June 30,
1949, ch. 288, title I, § 103(a), 63 Stat. 380.)
REFERENCES IN TEXT
This Act, referred to in text, is act July 3, 1946, ch.
538, 60 Stat. 421, as amended, known as the National
Mental Health Act, which enacted sections 232 and 242a
of this title, amended sections 201, 209, 210, 215, 218, 219,
241, 244, and 246 of this title, and enacted provisions set
out as notes under section 201 of this title. For complete classification of this Act to the Code, see Short
Title of 1946 Amendment note set out under section 201
of this title and Tables.
CODIFICATION
Section was enacted as a part of the National Mental
Health Act, and not as a part of the Public Health
Service Act which comprises this chapter.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Works Agency and of all agencies thereof, together with functions of Federal Works
Administrator transferred to Administrator of General
Services by section 103(a) of act June 30, 1949. Both Federal Works Agency and office of Federal Works Administrator abolished by section 103(b) of that act. See Historical and Revision Notes under section 303(b) of Title
40, Public Buildings, Property, and Works. Section
303(b) of Title 40 was amended generally by Pub. L.
109–313, § 2(a)(1), Oct. 6, 2006, 120 Stat. 1734, and, as so
amended, no longer relates to the Federal Works Agency and Commissioner of Public Buildings. See 2006
Amendment note under section 303 of Title 40.
EFFECTIVE DATE OF TRANSFER OF FUNCTIONS
Transfer of functions by act June 30, 1949, effective
July 1, 1949, see section 605, formerly section 505, of act
June 30, 1949, ch. 288, 63 Stat. 403; renumbered by act
Sept. 5, 1950, ch. 849, § 6(a), (b), 64 Stat. 583.

§ 233. Civil actions or proceedings against commissioned officers or employees
(a) Exclusiveness of remedy
The remedy against the United States provided by sections 1346(b) and 2672 of title 28, or
by alternative benefits provided by the United
States where the availability of such benefits
precludes a remedy under section 1346(b) of title
28, for damage for personal injury, including
death, resulting from the performance of medical, surgical, dental, or related functions, including the conduct of clinical studies or investigation, by any commissioned officer or em-

§ 233

ployee of the Public Health Service while acting
within the scope of his office or employment,
shall be exclusive of any other civil action or
proceeding by reason of the same subject-matter
against the officer or employee (or his estate)
whose act or omission gave rise to the claim.
(b) Attorney General to defend action or proceeding; delivery of process to designated official; furnishing of copies of pleading and
process to United States attorney, Attorney
General, and Secretary
The Attorney General shall defend any civil
action or proceeding brought in any court
against any person referred to in subsection (a)
of this section (or his estate) for any such damage or injury. Any such person against whom
such civil action or proceeding is brought shall
deliver within such time after date of service or
knowledge of service as determined by the Attorney General, all process served upon him or
an attested true copy thereof to his immediate
superior or to whomever was designated by the
Secretary to receive such papers and such person shall promptly furnish copies of the pleading
and process therein to the United States attorney for the district embracing the place wherein
the proceeding is brought, to the Attorney General, and to the Secretary.
(c) Removal to United States district court; procedure; proceeding upon removal deemed a
tort action against United States; hearing on
motion to remand to determine availability
of remedy against United States; remand to
State court or dismissal
Upon a certification by the Attorney General
that the defendant was acting in the scope of his
employment at the time of the incident out of
which the suit arose, any such civil action or
proceeding commenced in a State court shall be
removed without bond at any time before trial
by the Attorney General to the district court of
the United States of the district and division
embracing the place wherein it is pending and
the proceeding deemed a tort action brought
against the United States under the provisions
of title 28 and all references thereto. Should a
United States district court determine on a
hearing on a motion to remand held before a
trial on the merit that the case so removed is
one in which a remedy by suit within the meaning of subsection (a) of this section is not available against the United States, the case shall be
remanded to the State Court: Provided, That
where such a remedy is precluded because of the
availability of a remedy through proceedings for
compensation or other benefits from the United
States as provided by any other law, the case
shall be dismissed, but in the event the running
of any limitation of time for commencing, or filing an application or claim in, such proceedings
for compensation or other benefits shall be
deemed to have been suspended during the pendency of the civil action or proceeding under this
section.
(d) Compromise or settlement of claim by Attorney General
The Attorney General may compromise or settle any claim asserted in such civil action or
proceeding in the manner provided in section
2677 of title 28 and with the same effect.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Assault or battery
For purposes of this section, the provisions of
section 2680(h) of title 28 shall not apply to assault or battery arising out of negligence in the
performance of medical, surgical, dental, or related functions, including the conduct of clinical
studies or investigations.
(f) Authority of Secretary or designee to hold
harmless or provide liability insurance for
assigned or detailed employees
The Secretary or his designee may, to the extent that he deems appropriate, hold harmless
or provide liability insurance for any officer or
employee of the Public Health Service for damage for personal injury, including death, negligently caused by such officer or employee
while acting within the scope of his office or employment and as a result of the performance of
medical, surgical, dental, or related functions,
including the conduct of clinical studies or investigations, if such employee is assigned to a
foreign country or detailed to a State or political subdivision thereof or to a non-profit institution, and if the circumstances are such as are
likely to preclude the remedies of third persons
against the United States described in section
2679(b) of title 28, for such damage or injury.
(g) Exclusivity of remedy against United States
for entities deemed Public Health Service
employees; coverage for services furnished to
individuals other than center patients; application process; subrogation of medical malpractice claims; applicable period; entity and
contractor defined
(1)(A) For purposes of this section and subject
to the approval by the Secretary of an application under subparagraph (D), an entity described
in paragraph (4), and any officer, governing
board member, or employee of such an entity,
and any contractor of such an entity who is a
physician or other licensed or certified health
care practitioner (subject to paragraph (5)),
shall be deemed to be an employee of the Public
Health Service for a calendar year that begins
during a fiscal year for which a transfer was
made under subsection (k)(3) of this section
(subject to paragraph (3)). The remedy against
the United States for an entity described in
paragraph (4) and any officer, governing board
member, employee, or contractor (subject to
paragraph (5)) of such an entity who is deemed
to be an employee of the Public Health Service
pursuant to this paragraph shall be exclusive of
any other civil action or proceeding to the same
extent as the remedy against the United States
is exclusive pursuant to subsection (a) of this
section.
(B) The deeming of any entity or officer, governing board member, employee, or contractor
of the entity to be an employee of the Public
Health Service for purposes of this section shall
apply with respect to services provided—
(i) to all patients of the entity, and
(ii) subject to subparagraph (C), to individuals who are not patients of the entity.
(C) Subparagraph (B)(ii) applies to services
provided to individuals who are not patients of
an entity if the Secretary determines, after reviewing an application submitted under sub-

Page 84

paragraph (D), that the provision of the services
to such individuals—
(i) benefits patients of the entity and general populations that could be served by the
entity through community-wide intervention
efforts within the communities served by such
entity;
(ii) facilitates the provision of services to
patients of the entity; or
(iii) are otherwise required under an employment contract (or similar arrangement) between the entity and an officer, governing
board member, employee, or contractor of the
entity.
(D) The Secretary may not under subparagraph (A) deem an entity or an officer, governing board member, employee, or contractor of
the entity to be an employee of the Public
Health Service for purposes of this section, and
may not apply such deeming to services described in subparagraph (B)(ii), unless the entity
has submitted an application for such deeming
to the Secretary in such form and such manner
as the Secretary shall prescribe. The application
shall contain detailed information, along with
supporting documentation, to verify that the
entity, and the officer, governing board member,
employee, or contractor of the entity, as the
case may be, meets the requirements of subparagraphs (B) and (C) of this paragraph and that the
entity meets the requirements of paragraphs (1)
through (4) of subsection (h) of this section.
(E) The Secretary shall make a determination
of whether an entity or an officer, governing
board member, employee, or contractor of the
entity is deemed to be an employee of the Public
Health Service for purposes of this section within 30 days after the receipt of an application
under subparagraph (D). The determination of
the Secretary that an entity or an officer, governing board member, employee, or contractor
of the entity is deemed to be an employee of the
Public Health Service for purposes of this section shall apply for the period specified by the
Secretary under subparagraph (A).
(F) Once the Secretary makes a determination
that an entity or an officer, governing board
member, employee, or contractor of an entity is
deemed to be an employee of the Public Health
Service for purposes of this section, the determination shall be final and binding upon the
Secretary and the Attorney General and other
parties to any civil action or proceeding. Except
as provided in subsection (i) of this section, the
Secretary and the Attorney General may not determine that the provision of services which are
the subject of such a determination are not covered under this section.
(G) In the case of an entity described in paragraph (4) that has not submitted an application
under subparagraph (D):
(i) The Secretary may not consider the entity in making estimates under subsection
(k)(1) of this section.
(ii) This section does not affect any authority of the entity to purchase medical malpractice liability insurance coverage with Federal funds provided to the entity under section
254b, 254b, or 256a of this title.1
1 See

References in Text notes below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(H) In the case of an entity described in paragraph (4) for which an application under subparagraph (D) is in effect, the entity may,
through notifying the Secretary in writing,
elect to terminate the applicability of this subsection to the entity. With respect to such election by the entity:
(i) The election is effective upon the expiration of the 30-day period beginning on the date
on which the entity submits such notification.
(ii) Upon taking effect, the election terminates the applicability of this subsection to
the entity and each officer, governing board
member, employee, and contractor of the entity.
(iii) Upon the effective date for the election,
clauses (i) and (ii) of subparagraph (G) apply
to the entity to the same extent and in the
same manner as such clauses apply to an entity that has not submitted an application
under subparagraph (D).
(iv) If after making the election the entity
submits an application under subparagraph
(D), the election does not preclude the Secretary from approving the application ( 2 and
thereby restoring the applicability of this subsection to the entity and each officer, governing board member, employee, and contractor
of the entity, subject to the provisions of this
subsection and the subsequent provisions of
this section.
(2) If, with respect to an entity or person
deemed to be an employee for purposes of paragraph (1), a cause of action is instituted against
the United States pursuant to this section, any
claim of the entity or person for benefits under
an insurance policy with respect to medical malpractice relating to such cause of action shall be
subrogated to the United States.
(3) This subsection shall apply with respect to
a cause of action arising from an act or omission
which occurs on or after January 1, 1993.
(4) An entity described in this paragraph is a
public or non-profit private entity receiving
Federal funds under section 254b of this title.
(5) For purposes of paragraph (1), an individual
may be considered a contractor of an entity described in paragraph (4) only if—
(A) the individual normally performs on average at least 321⁄2 hours of service per week
for the entity for the period of the contract; or
(B) in the case of an individual who normally performs an average of less than 321⁄2
hours of services per week for the entity for
the period of the contract, the individual is a
licensed or certified provider of services in the
fields of family practice, general internal medicine, general pediatrics, or obstetrics and
gynecology.
(h) Qualifications for designation as Public
Health Service employee
The Secretary may not approve an application
under subsection (g)(1)(D) of this section unless
the Secretary determines that the entity—
(1) has implemented appropriate policies and
procedures to reduce the risk of malpractice
and the risk of lawsuits arising out of any
health or health-related functions performed
by the entity;
2 So

in original. There is no closing parenthesis.

§ 233

(2) has reviewed and verified the professional
credentials, references, claims history, fitness,
professional review organization findings, and
license status of its physicians and other licensed or certified health care practitioners,
and, where necessary, has obtained the permission from these individuals to gain access
to this information;
(3) has no history of claims having been filed
against the United States as a result of the application of this section to the entity or its officers, employees, or contractors as provided
for under this section, or, if such a history exists, has fully cooperated with the Attorney
General in defending against any such claims
and either has taken, or will take, any necessary corrective steps to assure against such
claims in the future; and
(4) will fully cooperate with the Attorney
General in providing information relating to
an estimate described under subsection (k) of
this section.
(i) Authority of Attorney General to exclude
health care professionals from coverage
(1) Notwithstanding subsection (g)(1) of this
section, the Attorney General, in consultation
with the Secretary, may on the record determine, after notice and opportunity for a full and
fair hearing, that an individual physician or
other licensed or certified health care practitioner who is an officer, employee, or contractor
of an entity described in subsection (g)(4) of this
section shall not be deemed to be an employee of
the Public Health Service for purposes of this
section, if treating such individual as such an
employee would expose the Government to an
unreasonably high degree of risk of loss because
such individual—
(A) does not comply with the policies and
procedures that the entity has implemented
pursuant to subsection (h)(1) of this section;
(B) has a history of claims filed against him
or her as provided for under this section that
is outside the norm for licensed or certified
health care practitioners within the same specialty;
(C) refused to reasonably cooperate with the
Attorney General in defending against any
such claim;
(D) provided false information relevant to
the individual’s performance of his or her duties to the Secretary, the Attorney General, or
an applicant for or recipient of funds under
this chapter; or
(E) was the subject of disciplinary action
taken by a State medical licensing authority
or a State or national professional society.
(2) A final determination by the Attorney General under this subsection that an individual
physician or other licensed or certified health
care professional shall not be deemed to be an
employee of the Public Health Service shall be
effective upon receipt by the entity employing
such individual of notice of such determination,
and shall apply only to acts or omissions occurring after the date such notice is received.
(j) Remedy for denial of hospital admitting privileges to certain health care providers
In the case of a health care provider who is an
officer, employee, or contractor of an entity de-

§ 233

TITLE 42—THE PUBLIC HEALTH AND WELFARE

scribed in subsection (g)(4) of this section, section 254h(e) of this title shall apply with respect
to the provider to the same extent and in the
same manner as such section applies to any
member of the National Health Service Corps.
(k) Estimate of annual claims by Attorney General; criteria; establishment of fund; transfer
of funds to Treasury accounts
(1)(A) For each fiscal year, the Attorney General, in consultation with the Secretary, shall
estimate by the beginning of the year the
amount of all claims which are expected to arise
under this section (together with related fees
and expenses of witnesses) for which payment is
expected to be made in accordance with section
1346 and chapter 171 of title 28 from the acts or
omissions, during the calendar year that begins
during that fiscal year, of entities described in
subsection (g)(4) of this section and of officers,
employees, or contractors (subject to subsection
(g)(5) of this section) of such entities.
(B) The estimate under subparagraph (A) shall
take into account—
(i) the value and frequency of all claims for
damage for personal injury, including death,
resulting from the performance of medical,
surgical, dental, or related functions by entities described in subsection (g)(4) of this section or by officers, employees, or contractors
(subject to subsection (g)(5) of this section) of
such entities who are deemed to be employees
of the Public Health Service under subsection
(g)(1) of this section that, during the preceding
5-year period, are filed under this section or,
with respect to years occurring before this
subsection takes effect, are filed against persons other than the United States,
(ii) the amounts paid during that 5-year period on all claims described in clause (i), regardless of when such claims were filed, adjusted to reflect payments which would not be
permitted under section 1346 and chapter 171 of
title 28, and
(iii) amounts in the fund established under
paragraph (2) but unspent from prior fiscal
years.
(2) Subject to appropriations, for each fiscal
year, the Secretary shall establish a fund of an
amount equal to the amount estimated under
paragraph (1) that is attributable to entities receiving funds under each of the grant programs
described in paragraph (4) of subsection (g) of
this section, but not to exceed a total of
$10,000,000 for each such fiscal year. Appropriations for purposes of this paragraph shall be
made separate from appropriations made for
purposes of sections 254b, 254b and 256a of this
title.1
(3) In order for payments to be made for judgments against the United States (together with
related fees and expenses of witnesses) pursuant
to this section arising from the acts or omissions of entities described in subsection (g)(4) of
this section and of officers, governing board
member,3 employees, or contractors (subject to
subsection (g)(5) of this section) of such entities,
the total amount contained within the fund established by the Secretary under paragraph (2)
3 So

in original. Probably should be ‘‘members,’’.

Page 86

for a fiscal year shall be transferred not later
than the December 31 that occurs during the fiscal year to the appropriate accounts in the
Treasury.
(l) Timely response to filing of action or proceeding
(1) If a civil action or proceeding is filed in a
State court against any entity described in subsection (g)(4) of this section or any officer, governing board member, employee, or any contractor of such an entity for damages described in
subsection (a) of this section, the Attorney General, within 15 days after being notified of such
filing, shall make an appearance in such court
and advise such court as to whether the Secretary has determined under subsections (g) and
(h) of this section, that such entity, officer, governing board member, employee, or contractor
of the entity is deemed to be an employee of the
Public Health Service for purposes of this section with respect to the actions or omissions
that are the subject of such civil action or proceeding. Such advice shall be deemed to satisfy
the provisions of subsection (c) of this section
that the Attorney General certify that an entity, officer, governing board member, employee, or contractor of the entity was acting
within the scope of their employment or responsibility.
(2) If the Attorney General fails to appear in
State court within the time period prescribed
under paragraph (1), upon petition of any entity
or officer, governing board member, employee,
or contractor of the entity named, the civil action or proceeding shall be removed to the appropriate United States district court. The civil
action or proceeding shall be stayed in such
court until such court conducts a hearing, and
makes a determination, as to the appropriate
forum or procedure for the assertion of the
claim for damages described in subsection (a) of
this section and issues an order consistent with
such determination.
(m) Application of coverage to managed care
plans
(1) An entity or officer, governing board member, employee, or contractor of an entity described in subsection (g)(1) of this section shall,
for purposes of this section, be deemed to be an
employee of the Public Health Service with respect to services provided to individuals who are
enrollees of a managed care plan if the entity
contracts with such managed care plan for the
provision of services.
(2) Each managed care plan which enters into
a contract with an entity described in subsection (g)(4) of this section shall deem the entity and any officer, governing board member,
employee, or contractor of the entity as meeting
whatever malpractice coverage requirements
such plan may require of contracting providers
for a calendar year if such entity or officer, governing board member, employee, or contractor
of the entity has been deemed to be an employee
of the Public Health Service for purposes of this
section for such calendar year. Any plan which
is found by the Secretary on the record, after
notice and an opportunity for a full and fair
hearing, to have violated this subsection shall
upon such finding cease, for a period to be deter-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

mined by the Secretary, to receive and to be eligible to receive any Federal funds under titles
XVIII or XIX of the Social Security Act [42
U.S.C. 1395 et seq., 1396 et seq.].
(3) For purposes of this subsection, the term
‘‘managed care plan’’ shall mean health maintenance organizations and similar entities that
contract at-risk with payors for the provision of
health services or plan enrollees and which contract with providers (such as entities described
in subsection (g)(4) of this section) for the delivery of such services to plan enrollees.
(n) Report on risk exposure of covered entities
(1) Not later than one year after December 26,
1995, the Comptroller General of the United
States shall submit to the Congress a report on
the following:
(A) The medical malpractice liability claims
experience of entities that have been deemed
to be employees for purposes of this section.
(B) The risk exposure of such entities.
(C) The value of private sector risk-management services, and the value of risk-management services and procedures required as a
condition of receiving a grant under section
254b, 254b, or 256a of this title.4
(D) A comparison of the costs and the benefits to taxpayers of maintaining medical malpractice liability coverage for such entities
pursuant to this section, taking into account—
(i) a comparison of the costs of premiums
paid by such entities for private medical
malpractice liability insurance with the cost
of coverage pursuant to this section; and
(ii) an analysis of whether the cost of premiums for private medical malpractice liability insurance coverage is consistent with
the liability claims experience of such entities.
(2) The report under paragraph (1) shall include the following:
(A) A comparison of—
(i) an estimate of the aggregate amounts
that such entities (together with the officers, governing board members, employees,
and contractors of such entities who have
been deemed to be employees for purposes of
this section) would have directly or indirectly paid in premiums to obtain medical
malpractice liability insurance coverage if
this section were not in effect; with
(ii) the aggregate amounts by which the
grants received by such entities under this
chapter were reduced pursuant to subsection
(k)(2) of this section.
(B) A comparison of—
(i) an estimate of the amount of privately
offered such insurance that such entities (together with the officers, governing board
members, employees, and contractors of
such entities who have been deemed to be
employees for purposes of this section) purchased during the three-year period beginning on January 1, 1993; with
(ii) an estimate of the amount of such insurance that such entities (together with the
4 See

References in Text notes below.

§ 233

officers, governing board members, employees, and contractors of such entities who
have been deemed to be employees for purposes of this section) will purchase after December 26, 1995.
(C) An estimate of the medical malpractice
liability loss history of such entities for the
10-year period preceding October 1, 1996, including but not limited to the following:
(i) Claims that have been paid and that are
estimated to be paid, and legal expenses to
handle such claims that have been paid and
that are estimated to be paid, by the Federal
Government pursuant to deeming entities as
employees for purposes of this section.
(ii) Claims that have been paid and that
are estimated to be paid, and legal expenses
to handle such claims that have been paid
and that are estimated to be paid, by private
medical malpractice liability insurance.
(D) An analysis of whether the cost of premiums for private medical malpractice liability insurance coverage is consistent with the
liability claims experience of entities that
have been deemed as employees for purposes of
this section.
(3) In preparing the report under paragraph (1),
the Comptroller General of the United States
shall consult with public and private entities
with expertise on the matters with which the report is concerned.
(o) Volunteer services provided by health professionals at free clinics
(1) For purposes of this section, a free clinic
health professional shall in providing a qualifying health service to an individual, or an officer,
governing board member, employee, or contractor of a free clinic shall in providing services for
the free clinic, be deemed to be an employee of
the Public Health Service for a calendar year
that begins during a fiscal year for which a
transfer was made under paragraph (6)(D). The
preceding sentence is subject to the provisions
of this subsection.
(2) In providing a health service to an individual, a health care practitioner shall for purposes
of this subsection be considered to be a free clinic health professional if the following conditions
are met:
(A) The service is provided to the individual
at a free clinic, or through offsite programs or
events carried out by the free clinic.
(B) The free clinic is sponsoring the health
care practitioner pursuant to paragraph (5)(C).
(C) The service is a qualifying health service
(as defined in paragraph (4)).
(D) Neither the health care practitioner nor
the free clinic receives any compensation for
the service from the individual or from any
third-party payor (including reimbursement
under any insurance policy or health plan, or
under any Federal or State health benefits
program). With respect to compliance with
such condition:
(i) The health care practitioner may receive repayment from the free clinic for reasonable expenses incurred by the health care
practitioner in the provision of the service
to the individual.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) The free clinic may accept voluntary
donations for the provision of the service by
the health care practitioner to the individual.
(E) Before the service is provided, the health
care practitioner or the free clinic provides
written notice to the individual of the extent
to which the legal liability of the health care
practitioner is limited pursuant to this subsection (or in the case of an emergency, the
written notice is provided to the individual as
soon after the emergency as is practicable). If
the individual is a minor or is otherwise legally incompetent, the condition under this
subparagraph is that the written notice be
provided to a legal guardian or other person
with legal responsibility for the care of the individual.
(F) At the time the service is provided, the
health care practitioner is licensed or certified
in accordance with applicable law regarding
the provision of the service.
(3)(A) For purposes of this subsection, the
term ‘‘free clinic’’ means a health care facility
operated by a nonprofit private entity meeting
the following requirements:
(i) The entity does not, in providing health
services through the facility, accept reimbursement from any third-party payor (including reimbursement under any insurance policy
or health plan, or under any Federal or State
health benefits program).
(ii) The entity, in providing health services
through the facility, either does not impose
charges on the individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved to
pay the charge.
(iii) The entity is licensed or certified in accordance with applicable law regarding the
provision of health services.
(B) With respect to compliance with the conditions under subparagraph (A), the entity involved may accept voluntary donations for the
provision of services.
(4) For purposes of this subsection, the term
‘‘qualifying health service’’ means any medical
assistance required or authorized to be provided
in the program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], without regard to whether the medical assistance is included in the plan submitted under such program by the State in which the health care
practitioner involved provides the medical assistance. References in the preceding sentence
to such program shall as applicable be considered to be references to any successor to such
program.
(5) Subsection (g) of this section (other than
paragraphs (3) through (5)) and subsections (h),
(i), and (l) of this section apply to a health care
practitioner for purposes of this subsection to
the same extent and in the same manner as such
subsections apply to an officer, governing board
member, employee, or contractor of an entity
described in subsection (g)(4) of this section,
subject to paragraph (6) and subject to the following:
(A) The first sentence of paragraph (1) applies in lieu of the first sentence of subsection
(g)(1)(A) of this section.

Page 88

(B) This subsection may not be construed as
deeming any free clinic to be an employee of
the Public Health Service for purposes of this
section.
(C) With respect to a free clinic, a health
care practitioner is not a free clinic health
professional unless the free clinic sponsors the
health care practitioner. For purposes of this
subsection, the free clinic shall be considered
to be sponsoring the health care practitioner
if—
(i) with respect to the health care practitioner, the free clinic submits to the Secretary an application meeting the requirements of subsection (g)(1)(D) of this section;
and
(ii) the Secretary, pursuant to subsection
(g)(1)(E) of this section, determines that the
health care practitioner is deemed to be an
employee of the Public Health Service.
(D) In the case of a health care practitioner
who is determined by the Secretary pursuant
to subsection (g)(1)(E) of this section to be a
free clinic health professional, this subsection
applies to the health care practitioner (with
respect to the free clinic sponsoring the health
care practitioner pursuant to subparagraph
(C)) for any cause of action arising from an act
or omission of the health care practitioner occurring on or after the date on which the Secretary makes such determination.
(E) Subsection (g)(1)(F) of this section applies to a health care practitioner for purposes
of this subsection only to the extent that, in
providing health services to an individual,
each of the conditions specified in paragraph
(2) is met.
(6)(A) For purposes of making payments for
judgments against the United States (together
with related fees and expenses of witnesses) pursuant to this section arising from the acts or
omissions of free clinic health professionals,
there is authorized to be appropriated $10,000,000
for each fiscal year.
(B) The Secretary shall establish a fund for
purposes of this subsection. Each fiscal year
amounts appropriated under subparagraph (A)
shall be deposited in such fund.
(C) Not later than May 1 of each fiscal year,
the Attorney General, in consultation with the
Secretary, shall submit to the Congress a report
providing an estimate of the amount of claims
(together with related fees and expenses of witnesses) that, by reason of the acts or omissions
of free clinic health professionals, will be paid
pursuant to this section during the calendar
year that begins in the following fiscal year.
Subsection (k)(1)(B) of this section applies to
the estimate under the preceding sentence regarding free clinic health professionals to the
same extent and in the same manner as such
subsection applies to the estimate under such
subsection regarding officers, governing board
members, employees, and contractors of entities
described in subsection (g)(4) of this section.
(D) Not later than December 31 of each fiscal
year, the Secretary shall transfer from the fund
under subparagraph (B) to the appropriate accounts in the Treasury an amount equal to the
estimate made under subparagraph (C) for the

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calendar year beginning in such fiscal year, subject to the extent of amounts in the fund.
(7)(A) This subsection takes effect on the date
of the enactment of the first appropriations Act
that makes an appropriation under paragraph
(6)(A), except as provided in subparagraph (B)(i).
(B)(i) Effective on August 21, 1996—
(I) the Secretary may issue regulations for
carrying out this subsection, and the Secretary may accept and consider applications
submitted pursuant to paragraph (5)(C); and
(II) reports under paragraph (6)(C) may be
submitted to the Congress.
(ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of
paragraph (6), if an estimate under subparagraph
(C) of such paragraph has not been made for the
calendar year beginning in such fiscal year, the
transfer under subparagraph (D) of such paragraph shall be made notwithstanding the lack of
the estimate, and the transfer shall be made in
an amount equal to the amount of such appropriation.
(p) Administration of smallpox countermeasures
by health professionals
(1) In general
For purposes of this section, and subject to
other provisions of this subsection, a covered
person shall be deemed to be an employee of
the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an
individual during the effective period of a declaration by the Secretary under paragraph
(2)(A).
(2) Declaration by Secretary concerning countermeasure against smallpox
(A) Authority to issue declaration
(i) In general
The Secretary may issue a declaration,
pursuant to this paragraph, concluding
that an actual or potential bioterrorist incident or other actual or potential public
health emergency makes advisable the administration of a covered countermeasure
to a category or categories of individuals.
(ii) Covered countermeasure
The Secretary shall specify in such declaration the substance or substances that
shall be considered covered countermeasures (as defined in paragraph (7)(A))
for purposes of administration to individuals during the effective period of the declaration.
(iii) Effective period
The Secretary shall specify in such declaration the beginning and ending dates of
the effective period of the declaration, and
may subsequently amend such declaration
to shorten or extend such effective period,
provided that the new closing date is after
the date when the declaration is amended.
(iv) Publication
The Secretary shall promptly publish
each such declaration and amendment in
the Federal Register.

§ 233

(B) Liability of United States only for administrations within scope of declaration
Except as provided in paragraph (5)(B)(ii),
the United States shall be liable under this
subsection with respect to a claim arising
out of the administration of a covered countermeasure to an individual only if—
(i) the countermeasure was administered
by a qualified person, for a purpose stated
in paragraph (7)(A)(i), and during the effective period of a declaration by the Secretary under subparagraph (A) with respect to such countermeasure; and
(ii)(I) the individual was within a category of individuals covered by the declaration; or
(II) the qualified person administering
the
countermeasure
had
reasonable
grounds to believe that such individual
was within such category.
(C) Presumption of administration within
scope of declaration in case of accidental
vaccinia inoculation
(i) In general
If vaccinia vaccine is a covered countermeasure specified in a declaration under
subparagraph (A), and an individual to
whom the vaccinia vaccine is not administered contracts vaccinia, then, under the
circumstances specified in clause (ii), the
individual—
(I) shall be rebuttably presumed to
have contracted vaccinia from an individual to whom such vaccine was administered as provided by clauses (i) and (ii)
of subparagraph (B); and
(II) shall (unless such presumption is
rebutted) be deemed for purposes of this
subsection to be an individual to whom a
covered countermeasure was administered by a qualified person in accordance
with the terms of such declaration and
as described by subparagraph (B).
(ii) Circumstances in which presumption
applies
The presumption and deeming stated in
clause (i) shall apply if—
(I) the individual contracts vaccinia
during the effective period of a declaration under subparagraph (A) or by the
date 30 days after the close of such period; or
(II) the individual has resided with, or
has had contact with, an individual to
whom such vaccine was administered as
provided by clauses (i) and (ii) of subparagraph (B) and contracts vaccinia
after such date.
(D) Acts and omissions deemed to be within
scope of employment
(i) In general
In the case of a claim arising out of alleged transmission of vaccinia from an individual described in clause (ii), acts or
omissions by such individual shall be
deemed to have been taken within the
scope of such individual’s office or employment for purposes of—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(I) subsection (a) of this section; and
(II) section 1346(b) and chapter 171 of
title 28.
(ii) Individuals to whom deeming applies
An individual is described by this clause
if—
(I) vaccinia vaccine was administered
to such individual as provided by subparagraph (B); and
(II) such individual was within a category of individuals covered by a declaration under subparagraph (A)(i).
(3) Exhaustion; exclusivity; offset
(A) Exhaustion
(i) In general
A person may not bring a claim under
this subsection unless such person has exhausted such remedies as are available
under part C of this subchapter, except
that if the Secretary fails to make a final
determination on a request for benefits or
compensation filed in accordance with the
requirements of such part within 240 days
after such request was filed, the individual
may seek any remedy that may be available under this section.
(ii) Tolling of statute of limitations
The time limit for filing a claim under
this subsection, or for filing an action
based on such claim, shall be tolled during
the pendency of a request for benefits or
compensation under part C of this subchapter.
(iii) Construction
This subsection shall not be construed as
superseding or otherwise affecting the application of a requirement, under chapter
171 of title 28, to exhaust administrative
remedies.
(B) Exclusivity
The remedy provided by subsection (a) of
this section shall be exclusive of any other
civil action or proceeding for any claim or
suit this subsection encompasses, except for
a proceeding under part C of this subchapter.
(C) Offset
The value of all compensation and benefits
provided under part C of this subchapter for
an incident or series of incidents shall be offset against the amount of an award, compromise, or settlement of money damages in
a claim or suit under this subsection based
on the same incident or series of incidents.
(4) Certification of action by Attorney General
Subsection (c) of this section applies to actions under this subsection, subject to the following provisions:
(A) Nature of certification
The certification by the Attorney General
that is the basis for deeming an action or
proceeding to be against the United States,
and for removing an action or proceeding
from a State court, is a certification that
the action or proceeding is against a covered
person and is based upon a claim alleging

Page 90

personal injury or death arising out of the
administration of a covered countermeasure.
(B) Certification of Attorney General conclusive
The certification of the Attorney General
of the facts specified in subparagraph (A)
shall conclusively establish such facts for
purposes of jurisdiction pursuant to this subsection.
(5) Covered person to cooperate with United
States
(A) In general
A covered person shall cooperate with the
United States in the processing and defense
of a claim or action under this subsection
based upon alleged acts or omissions of such
person.
(B) Consequences of failure to cooperate
Upon the motion of the United States or
any other party and upon finding that such
person has failed to so cooperate—
(i) the court shall substitute such person
as the party defendant in place of the
United States and, upon motion, shall remand any such suit to the court in which
it was instituted if it appears that the
court lacks subject matter jurisdiction;
(ii) the United States shall not be liable
based on the acts or omissions of such person; and
(iii) the Attorney General shall not be
obligated to defend such action.
(6) Recourse against covered person in case of
gross misconduct or contract violation
(A) In general
Should payment be made by the United
States to any claimant bringing a claim
under this subsection, either by way of administrative determination, settlement, or
court judgment, the United States shall
have, notwithstanding any provision of
State law, the right to recover for that portion of the damages so awarded or paid, as
well as interest and any costs of litigation,
resulting from the failure of any covered
person to carry out any obligation or responsibility assumed by such person under a contract with the United States or from any
grossly negligent, reckless, or illegal conduct or willful misconduct on the part of
such person.
(B) Venue
The United States may maintain an action
under this paragraph against such person in
the district court of the United States in
which such person resides or has its principal place of business.
(7) Definitions
As used in this subsection, terms have the
following meanings:
(A) Covered countermeasure
The term ‘‘covered countermeasure’’ or
‘‘covered countermeasure against smallpox’’,
means a substance that is—
(i)(I) used to prevent or treat smallpox
(including the vaccinia or another vaccine); or

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(II) used to control or treat the adverse
effects of vaccinia inoculation or of administration of another covered countermeasure; and
(ii) specified in a declaration under paragraph (2).
(B) Covered person
The term ‘‘covered person’’, when used
with respect to the administration of a covered countermeasure, means a person who
is—
(i) a manufacturer or distributor of such
countermeasure;
(ii) a health care entity under whose auspices—
(I) such countermeasure was administered;
(II) a determination was made as to
whether, or under what circumstances,
an individual should receive a covered
countermeasure;
(III) the immediate site of administration on the body of a covered countermeasure was monitored, managed, or
cared for; or
(IV) an evaluation was made of whether the administration of a countermeasure was effective;
(iii) a qualified person who administered
such countermeasure;
(iv) a State, a political subdivision of a
State, or an agency or official of a State or
of such a political subdivision, if such
State, subdivision, agency, or official has
established requirements, provided policy
guidance, supplied technical or scientific
advice or assistance, or otherwise supervised or administered a program with respect to administration of such countermeasures;
(v) in the case of a claim arising out of
alleged transmission of vaccinia from an
individual—
(I) the individual who allegedly transmitted the vaccinia, if vaccinia vaccine
was administered to such individual as
provided by paragraph (2)(B) and such individual was within a category of individuals covered by a declaration under
paragraph (2)(A)(i); or
(II) an entity that employs an individual described by clause (I) 5 or where
such individual has privileges or is
otherwise authorized to provide health
care;
(vi) an official, agent, or employee of a
person described in clause (i), (ii), (iii), or
(iv);
(vii) a contractor of, or a volunteer
working for, a person described in clause
(i), (ii), or (iv), if the contractor or volunteer performs a function for which a person described in clause (i), (ii), or (iv) is a
covered person; or
(viii) an individual who has privileges or
is otherwise authorized to provide health
care under the auspices of an entity described in clause (ii) or (v)(II).
5 So

in original. Probably should be ‘‘subclause’’.

§ 233

(C) Qualified person
The term ‘‘qualified person’’, when used
with respect to the administration of a covered countermeasure, means a licensed
health professional or other individual
who—
(i) is authorized to administer such
countermeasure under the law of the State
in which the countermeasure was administered; or
(ii) is otherwise authorized by the Secretary to administer such countermeasure.
(D) Arising out of administration of a covered countermeasure
The term ‘‘arising out of administration of
a covered countermeasure’’, when used with
respect to a claim or liability, includes a
claim or liability arising out of—
(i) determining whether, or under what
conditions, an individual should receive a
covered countermeasure;
(ii) obtaining informed consent of an individual to the administration of a covered
countermeasure;
(iii) monitoring, management, or care of
an immediate site of administration on
the body of a covered countermeasure, or
evaluation of whether the administration
of the countermeasure has been effective;
or
(iv) transmission of vaccinia virus by an
individual to whom vaccinia vaccine was
administered as provided by paragraph
(2)(B).
(July 1, 1944, ch. 373, title II, § 224, formerly § 223,
as added Pub. L. 91–623, § 4, Dec. 31, 1970, 84 Stat.
1870; renumbered § 224, Pub. L. 92–157, title III,
§ 301(c), Nov. 18, 1971, 85 Stat. 463; amended Pub.
L. 102–501, §§ 2–4, Oct. 24, 1992, 106 Stat. 3268–3270;
Pub. L. 103–183, title VII, § 706(a), Dec. 14, 1993,
107 Stat. 2241; Pub. L. 104–73, §§ 2–5(b), 6–11, Dec.
26, 1995, 109 Stat. 777–781; Pub. L. 104–191, title I,
§ 194, Aug. 21, 1996, 110 Stat. 1988; Pub. L. 104–299,
§ 4(a)(1), Oct. 11, 1996, 110 Stat. 3644; Pub. L.
107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1664; Pub. L. 107–296, title III, § 304(c), Nov. 25,
2002, 116 Stat. 2165; Pub. L. 108–20, § 3(a)–(i), Apr.
30, 2003, 117 Stat. 646–648; Pub. L. 108–163,
§ 2(m)(1), Dec. 6, 2003, 117 Stat. 2023; Pub. L.
111–148, title X, § 10608(a), Mar. 23, 2010, 124 Stat.
1014.)
REFERENCES IN TEXT
The references to section 254b of this title the first
place appearing in subsecs. (g)(1)(G)(ii), (k)(2), and
(n)(1)(C), were in the original references to section 329,
meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§ 254b et
seq.) of part D of subchapter II of this chapter by Pub.
L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626.
Section 256a of this title, referred to in subsecs.
(g)(1)(G)(ii), (k)(2), and (n)(1)(C), was repealed by Pub.
L. 104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645.
The Social Security Act, referred to in subsecs. (m)(2)
and (o)(4), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles XVIII and XIX of the Act are classified
generally to subchapters XVIII (§ 1395 et seq.) and XIX
(§ 1396 et seq.), respectively, of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
AMENDMENTS
2010—Subsec. (o)(1). Pub. L. 111–148 inserted ‘‘, or an
officer, governing board member, employee, or contrac-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tor of a free clinic shall in providing services for the
free clinic,’’ after ‘‘to an individual’’.
2003—Subsec. (g)(1)(G)(ii). Pub. L. 108–163 substituted
‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘, or’’.
Subsec. (k)(2). Pub. L. 108–163 substituted ‘‘254b’’ for
‘‘254c, 254b(h)’’ before ‘‘and’’.
Subsec. (n)(1)(C). Pub. L. 108–163 substituted ‘‘254b’’
for ‘‘254c, 254b(h)’’ before ‘‘, or’’.
Subsec. (p)(2)(A)(ii). Pub. L. 108–20, § 3(i), substituted
‘‘paragraph (7)(A)’’ for ‘‘paragraph(8)(A)’’.
Subsec. (p)(2)(C)(ii)(II). Pub. L. 108–20, § 3(a), substituted ‘‘has resided with, or has had contact with,’’
for ‘‘resides or has resided with’’.
Subsec. (p)(2)(D). Pub. L. 108–20, § 3(b), added subpar.
(D).
Subsec. (p)(3). Pub. L. 108–20, § 3(c), amended heading
and text of par. (3) generally. Prior to amendment, text
read as follows: ‘‘The remedy provided by subsection (a)
of this section shall be exclusive of any other civil action or proceeding for any claim or suit this subsection
encompasses.’’
Subsec. (p)(5). Pub. L. 108–20, § 3(d), substituted ‘‘Covered person’’ for ‘‘Defendant’’ in heading.
Subsec. (p)(7)(A)(i)(II). Pub. L. 108–20, § 3(e), amended
subcl. (II) generally. Prior to amendment, subcl. (II)
read as follows: ‘‘vaccinia immune globulin used to
control or treat the adverse effects of vaccinia inoculation; and’’.
Subsec. (p)(7)(B). Pub. L. 108–20, § 3(f)(1), substituted
‘‘means a person’’ for ‘‘includes any person’’ in introductory provisions.
Subsec. (p)(7)(B)(ii). Pub. L. 108–20, § 3(f)(2), substituted ‘‘auspices—’’ for ‘‘auspices’’, designated ‘‘such
countermeasure was administered;’’ as subcl. (I), and
added subcls. (II) to (IV).
Subsec. (p)(7)(B)(iv) to (viii). Pub. L. 108–20, § 3(f)(3),
(4), added cls. (iv) to (viii) and struck out former cl. (iv)
which read as follows: ‘‘an official, agent, or employee
of a person described in clause (i), (ii), or (iii).’’
Subsec. (p)(7)(C). Pub. L. 108–20, § 3(g), substituted
‘‘individual who—’’ for ‘‘individual who’’, designated
‘‘is authorized to administer such countermeasure
under the law of the State in which the countermeasure was administered.’’ as cl. (i), substituted
‘‘; or’’ for period at end of cl. (i), and added cl. (ii).
Subsec. (p)(7)(D). Pub. L. 108–20, § 3(h), added subpar.
(D).
2002—Subsecs. (g)(1)(G)(ii), (k)(2), (n)(1)(C). Pub. L.
107–251 substituted ‘‘254b(h)’’ for ‘‘256’’.
Subsec. (p). Pub. L. 107–296 added subsec. (p).
1996—Subsec. (g)(4). Pub. L. 104–299 substituted
‘‘under section 254b of this title.’’ for ‘‘under any of the
following grant programs:’’ and struck out subpars. (A)
to (D) which read as follows:
‘‘(A) Section 254b of this title (relating to grants for
migrant health centers).
‘‘(B) Section 254c of this title (relating to grants for
community health centers).
‘‘(C) Section 256 of this title (relating to grants for
health services for the homeless).
‘‘(D) Section 256a of this title (relating to grants for
health services for residents of public housing).’’
Subsec. (o). Pub. L. 104–191 added subsec. (o).
1995—Subsec. (g)(1). Pub. L. 104–73, §§ 3(1), 4, 5(a), designated existing provisions as subpar. (A), inserted
‘‘and subject to the approval by the Secretary of an application under subparagraph (D)’’ after ‘‘For purposes
of this section’’, substituted ‘‘an entity described in
paragraph (4), and any officer, governing board member, or employee of such an entity, and any contractor
of such an entity who is a physician or other licensed
or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the
Public Health Service for a calendar year that begins
during a fiscal year for which a transfer was made
under subsection (k)(3) of this section (subject to paragraph (3)). The remedy against the United States for an
entity described in paragraph (4) and any officer, governing board member, employee, or contractor’’ for
‘‘, an entity described in paragraph (4) and any officer,

Page 92

employee, or contractor (subject to paragraph (5)) of
such an entity who is a physician or other licensed or
certified health care practitioner shall be deemed to be
an employee of the Public Health Service for a calendar
year that begins during a fiscal year for which a transfer of the full amount estimated under subsection
(k)(1)(A) of this section was made under subsection
(k)(3) of this section (subject to paragraph (3)). The
remedy against the United States for an entity described in paragraph (4) and any officer, employee, or
contractor’’, and added subpars. (B) to (H).
Subsec. (g)(3). Pub. L. 104–73, § 2(a), struck out at end
‘‘This subsection shall not apply with respect to a
cause of action arising from an act or omission which
occurs on or after January 1, 1996.’’
Subsec. (g)(5)(B). Pub. L. 104–73, § 8, amended subpar.
(B) generally. Prior to amendment, subpar. (B) read as
follows: ‘‘in the case of an individual who normally performs on average less than 321⁄2 hours of services per
week for the entity for the period of the contract and
is a licensed or certified provider of obstetrical services—
‘‘(i) the individual’s medical malpractice liability
insurance coverage does not extend to services performed by the individual for the entity under the contract, or
‘‘(ii) the Secretary finds that patients to whom the
entity furnishes services will be deprived of obstetrical services if such individual is not considered a contractor of the entity for purposes of paragraph (1).’’
Subsec. (h). Pub. L. 104–73, § 5(b)(1), in introductory
provisions substituted ‘‘The Secretary may not approve
an application under subsection (g)(1)(D) of this section
unless the Secretary determines that the entity—’’ for
‘‘Notwithstanding subsection (g)(1) of this section, the
Secretary, in consultation with the Attorney General,
may not deem an entity described in subsection (g)(4)
of this section to be an employee of the Public Health
Service Act for purposes of this section unless the entity—’’.
Subsec. (h)(4). Pub. L. 104–73, § 5(b)(2), substituted
‘‘will fully cooperate’’ for ‘‘has fully cooperated’’.
Subsec. (i)(1). Pub. L. 104–73, § 9, substituted ‘‘may on
the record determine, after notice and opportunity for
a full and fair hearing’’ for ‘‘may determine, after notice and opportunity for a hearing’’.
Subsec. (k)(1)(A). Pub. L. 104–73, § 2(b)(1), substituted
‘‘For each fiscal year’’ for ‘‘For each of the fiscal years
1993, 1994, and 1995’’ and struck out ‘‘(except that an estimate shall be made for fiscal year 1993 by December
31, 1992, subject to an adjustment within 90 days thereafter)’’ after ‘‘beginning of the year’’.
Subsec. (k)(2). Pub. L. 104–73, §§ 2(b)(2), 10, substituted
‘‘for each fiscal year’’ for ‘‘for each of the fiscal years
1993, 1994, and 1995’’ and ‘‘$10,000,000’’ for ‘‘$30,000,000’’.
Subsec. (k)(3). Pub. L. 104–73, § 3(2), which directed
amendment of subsec. (k)(3) by inserting ‘‘governing
board member,’’ after ‘‘officer,’’, was executed by inserting such language after ‘‘officers,’’ to reflect the
probable intent of Congress.
Subsec. (l). Pub. L. 104–73, § 6, added subsec. (l).
Subsec. (m). Pub. L. 104–73, § 7, added subsec. (m).
Subsec. (n). Pub. L. 104–73, § 11, added subsec. (n).
1993—Subsec. (k)(2). Pub. L. 103–183 inserted at end
‘‘Appropriations for purposes of this paragraph shall be
made separate from appropriations made for purposes
of sections 254b, 254c, 256 and 256a of this title.’’
1992—Subsecs. (g) to (k). Pub. L. 102–501 added subsecs. (g) to (k).
EFFECTIVE DATE OF 2010 AMENDMENT
Pub. L. 111–148, title X, § 10608(b), Mar. 23, 2010, 124
Stat. 1014, provided that: ‘‘The amendment made by
this section [amending this section] shall take effect on
the date of enactment of this Act [Mar. 23, 2010] and
apply to any act or omission which occurs on or after
that date.’’
EFFECTIVE DATE OF 2003 AMENDMENTS
Pub. L. 108–163, § 3, Dec. 6, 2003, 117 Stat. 2023, provided
that: ‘‘This Act [see Short Title of 2003 Amendments

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 235

note set out under section 201 of this title] is deemed
to have taken effect immediately after the enactment
of Public Law 107–251 [Oct. 26, 2002].’’
Pub. L. 108–20, § 3(j), Apr. 30, 2003, 117 Stat. 649, provided that: ‘‘This section [amending this section] shall
take effect as of November 25, 2002.’’

amended Aug. 23, 1974, Pub. L. 93–385, § 1, 88 Stat. 741;
Apr. 22, 1976, Pub. L. 94–278, title IX, § 901, 90 Stat. 415;
Sept. 30, 1976, Pub. L. 94–437, title I, § 104, 90 Stat. 1403;
Oct. 12, 1976, Pub. L. 94–484, title I, § 101(t), 90 Stat. 2246,
related to Public Health and National Health Service
Corps Scholarship Training program.

EFFECTIVE DATE OF 2002 AMENDMENT

§ 235. Administration of grants in multigrant
projects; promulgation of regulations

Amendment by Pub. L. 107–296 effective 60 days after
Nov. 25, 2002, see section 4 of Pub. L. 107–296, set out as
an Effective Date note under section 101 of Title 6, Domestic Security.
EFFECTIVE DATE OF 1996 AMENDMENT
Section 5 of Pub. L. 104–299, as amended by Pub. L.
104–208, div. A, title I, § 101(e) [title V, § 521], Sept. 30,
1996, 110 Stat. 3009–233, 3009–275, provided that: ‘‘This
Act [enacting sections 254b and 254c of this title,
amending this section and sections 256c, 1395x, and
1396d of this title, repealing sections 256 and 256a of this
title, and enacting provisions set out as notes under
sections 201 and 254b of this title] and the amendments
made by this Act shall become effective on October 1,
1996.’’
[Section 101(e) [title V, § 521] of Pub. L. 104–208 provided that the amendment made by that section is effective on the day after Oct. 11, 1996.]
EFFECTIVE DATE OF 1995 AMENDMENT
Section 5(c) of Pub. L. 104–73 provided that: ‘‘If, on
the day before the date of the enactment of this Act
[Dec. 26, 1995], an entity was deemed to be an employee
of the Public Health Service for purposes of section
224(g) of the Public Health Service Act [subsec. (g) of
this section], the condition under paragraph (1)(D) of
such section (as added by subsection (a) of this section)
that an application be approved with respect to the entity does not apply until the expiration of the 180-day
period beginning on such date.’’
EFFECTIVE DATE OF 1992 AMENDMENT
Section 6 of Pub. L. 102–501 provided that: ‘‘The
amendments made by this Act [amending this section]
shall take effect on the date of the enactment of this
Act [Oct. 24, 1992].’’
REPORT ON RISK EXPOSURE OF COVERED ENTITIES

For the purpose of facilitating the administration of, and expediting the carrying out of the
purposes of, the programs established by subchapters V, VI, and VII 1 of this chapter, and sections 242b, 246(a), 246(b), 246(c), 246(d),1 and
246(e) 1 of this title in situations in which grants
are sought or made under two or more of such
programs with respect to a single project, the
Secretary is authorized to promulgate regulations—
(1) under which the administrative functions
under such programs with respect to such
project will be performed by a single administrative unit which is the administrative unit
charged with the administration of any of
such programs or is the administrative unit
charged with the supervision of two or more of
such programs;
(2) designed to reduce the number of applications, reports, and other materials required
under such programs to be submitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the
extent feasible), the data and information required to be contained in such applications,
reports, and other materials; and
(3) under which inconsistent or duplicative
requirements imposed by such programs will
be revised and made uniform with respect to
such project;
except that nothing in this section shall be construed to authorize the Secretary to waive or
suspend, with respect to any such project, any
requirement with respect to any of such programs if such requirement is imposed by law or
by any regulation required by law.

Pub. L. 102–501, § 5, Oct. 24, 1992, 106 Stat. 3271, provided that:
‘‘(a) IN GENERAL.—Not later than April 1, 1995, the Attorney General, in consultation with the Secretary of
Health and Human Services (hereafter referred to as
the ‘Secretary’), shall submit a report to Congress on
the medical malpractice liability claims experience of
entities subject to section 224(g) of the Public Health
Service Act [42 U.S.C. 233(g)] (as added by section 2(a))
and the risk exposure associated with such entities.
‘‘(b) EFFECT OF LIABILITY PROTECTIONS ON COSTS INCURRED BY COVERED ENTITIES.—The Attorney General’s
report under subsection (a) shall include an analysis by
the Secretary comparing—
‘‘(1) the Secretary’s estimate of the aggregate
amounts that such entities (together with the officers, employees, and contractors of such entities who
are subject to section 224(g) of such Act) would have
directly or indirectly paid to obtain medical malpractice liability insurance coverage had section
224(g) of the Public Health Service Act not been enacted into law, with
‘‘(2) the aggregate amounts by which the grants received by such entities under the Public Health Service Act [this chapter] were reduced as a result of the
enactment of section 224(k)(2) of such Act [42 U.S.C.
233(k)(2)].’’

Subchapters V and VI of this chapter, referred to in
text, are classified to sections 292 et seq. and 296 et seq.,
respectively, of this title.
Subchapter VII of this chapter, referred to in text,
which was classified to section 299 et seq. of this title,
was repealed by Pub. L. 99–117, § 12(d), Oct. 7, 1985, 99
Stat. 495.
Section 246(d) of this title, referred to in text, was repealed by Pub. L. 97–35, title IX, § 902(b), Aug. 13, 1981,
95 Stat. 559.
Section 246(e) of this title, referred to in text, was repealed by Pub. L. 94–63, title V, § 501(b), July 29, 1975, 89
Stat. 346.

§ 234. Repealed. Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2281, eff.
Oct. 1, 1977

Section was formerly classified to section 242i of this
title.

Section, act July 1, 1944, ch. 373, title II, § 225, as
added Oct. 27, 1972, Pub. L. 92–585, § 5, 86 Stat. 1293;

(July 1, 1944, ch. 373, title II, § 226, formerly title
III, § 310A, as added Pub. L. 91–515, title II, § 270,
Oct. 30, 1970, 84 Stat. 1306; amended Pub. L.
92–157, title II, § 201, Nov. 18, 1971, 85 Stat. 461; renumbered § 226, Pub. L. 93–353, title I, § 102(e),
July 23, 1974, 88 Stat. 362.)
REFERENCES IN TEXT

CODIFICATION

1 See

References in Text note below.

§ 236

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1971—Pub. L. 92–157 provided for administration of
programs established under subchapters V and VI of
this chapter.

§ 236. Orphan Products Board
(a) Establishment; composition; chairman
There is established in the Department of
Health and Human Services a board for the development of drugs (including biologics) and devices (including diagnostic products) for rare
diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of
the Department of Health and Human Services
and representatives, selected by the Secretary,
of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and any other Federal department or agency which the Secretary
determines has activities relating to drugs and
devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the
Board.
(b) Function
The function of the Board shall be to promote
the development of drugs and devices for rare
diseases or conditions and the coordination
among Federal, other public, and private agencies in carrying out their respective functions
relating to the development of such articles for
such diseases or conditions.
(c) Duties with respect to drugs for rare diseases
or conditions
In the case of drugs for rare diseases or conditions the Board shall—
(1) evaluate—
(A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360aa et seq.] on the development of such
drugs, and
(B) the implementation of such subchapter; 1
(2) evaluate the activities of the National Institutes of Health for the development of
drugs for such diseases or conditions,
(3) assure appropriate coordination among
the Food and Drug Administration, the National Institutes of Health and the Centers for
Disease Control and Prevention in the carrying out of their respective functions relating
to the development of drugs for such diseases
or conditions to assure that the activities of
each agency are complementary,
(4) assure appropriate coordination among
all interested Federal agencies, manufacturers, and organizations representing patients,
in their activities relating to such drugs,
(5) with the consent of the sponsor of a drug
for a rare disease or condition exempt under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 355(i)] or regulations
issued under such section, inform physicians
and the public respecting the availability of
such drug for such disease or condition and inform physicians and the public respecting the
1 So

in original. The semicolon probably should be a comma.

Page 94

availability of drugs approved under section
505(c) of such Act [21 U.S.C. 355(c)] or licensed
under section 262 of this title for rare diseases
or conditions,
(6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek investigators to facilitate the development of such drugs, and
seek business entities to participate in the distribution of such drugs, and
(7) recognize the efforts of public and private
entities and individuals in seeking the development of drugs for rare diseases or conditions
and in developing such drugs.
(d) Consultation
The Board shall consult with interested persons respecting the activities of the Board under
this section and as part of such consultation
shall provide the opportunity for the submission
of oral views.
(e) Annual report; contents
The Board shall submit to the Committee on
Labor and Human Resources of the Senate and
the Committee on Energy and Commerce of the
House of Representatives an annual report—
(1) identifying the drugs which have been
designated under section 526 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 360bb]
for a rare disease or condition,
(2) describing the activities of the Board,
and
(3) containing the results of the evaluations
carried out by the Board.
The Director of the National Institutes of
Health shall submit to the Board for inclusion
in the annual report a report on the rare disease
and condition research activities of the Institutes of the National Institutes of Health; the
Secretary of the Treasury shall submit to the
Board for inclusion in the annual report a report
on the use of the credit against tax provided by
section 44H 2 of title 26; and the Secretary of
Health and Human Services shall submit to the
Board for inclusion in the annual report a report
on the program of assistance under section 360ee
of title 21 for the development of drugs for rare
diseases and conditions. Each annual report
shall be submitted by June 1 of each year for the
preceding calendar year.
(July 1, 1944, ch. 373, title II, § 227, as added Pub.
L. 97–414, § 3, Jan. 4, 1983, 96 Stat. 2051; amended
Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095;
Pub. L. 102–321, title I, § 163(b)(1), July 10, 1992,
106 Stat. 375; Pub. L. 102–531, title III, § 312(d)(1),
Oct. 27, 1992, 106 Stat. 3504.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(1)(A), is act June 25, 1938, ch. 675, 52
Stat. 1040, as amended. Subchapter B of the Federal
Food, Drug, and Cosmetic Act probably means subchapter B of chapter V of the Federal Food, Drug, and
Cosmetic Act which is classified generally to part B
(section 360aa et seq.) of subchapter V of chapter 9 of
Title 21, Food and Drugs. For complete classification of
this Act to the Code, see section 301 of Title 21 and
Tables.
Section 44H of title 26, referred to in subsec. (e), was
renumbered section 28 of title 26, by Pub. L. 98–369, div.
2 See

References in Text note below.

Page 95

TITLE 42—THE PUBLIC HEALTH AND WELFARE

A, title IV, § 471(c)(1), July 18, 1984, 98 Stat. 826, and subsequently renumbered section 45C of title 26 by Pub. L.
104–188, title I, § 1205(a)(1), Aug. 20, 1996, 110 Stat. 1775.
PRIOR PROVISIONS
A prior section 236, act July 1, 1944, ch. 373, title II,
§ 227, formerly title III, § 310B, as added Oct. 30, 1970,
Pub. L. 91–515, title II, § 280, 84 Stat. 1307; renumbered
§ 227 and amended July 23, 1974, Pub. L. 93–353, title I,
§ 102(f), 88 Stat. 362, related to an annual report by Secretary on activities related to health facilities and
services and expenditure of funds, prior to repeal by
Pub. L. 97–35, title XXI, § 2193(b)(4), Aug. 13, 1981, 95
Stat. 827.
AMENDMENTS
1992—Subsec. (a). Pub. L. 102–531 substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’.
Subsec. (c)(2). Pub. L. 102–321, § 163(b)(1)(A), which directed the striking out of ‘‘, and the Alcohol, Drug
Abuse, and Mental Health Administration’’, was executed by striking ‘‘and the Alcohol, Drug Abuse, and
Mental Health Administration’’ after ‘‘National Institutes of Health’’ to reflect the probable intent of Congress.
Subsec. (c)(3). Pub. L. 102–531 substituted ‘‘Centers for
Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–321, § 163(b)(1)(B), struck out ‘‘, the Alcohol, Drug Abuse, and Mental Health Administration,’’
after ‘‘National Institutes of Health’’.
Subsec. (e). Pub. L. 102–321, § 163(b)(1)(C), (D), in concluding provisions, struck out ‘‘and the Administrator
of the Alcohol, Drug Abuse, and Mental Health Administration’’ after ‘‘National Institutes of Health’’ the
first place appearing and ‘‘and the Alcohol, Drug
Abuse, and Mental Health Administration’’ after ‘‘National Institutes of Health’’ the second place appearing.
1986—Subsec. (e). Pub. L. 99–514 substituted ‘‘Internal
Revenue Code of 1986’’ for ‘‘Internal Revenue Code of
1954’’, which for purposes of codification was translated
as ‘‘title 26’’ thus requiring no change in text.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1992 AMENDMENT
Pub. L. 102–321, title VIII, § 801, July 10, 1992, 106 Stat.
441, provided that:
‘‘(a) IN GENERAL.—This Act [See Tables for classification] takes effect on the date of the enactment of this
Act [July 10, 1992], subject to subsections (b) through
(d).
‘‘(b) AMENDMENTS.—The amendments described in
this Act are made on the date of the enactment of this
Act and take effect on such date, except as provided in
subsections (c) and (d).
‘‘(c) REORGANIZATION UNDER TITLE I.—Title I
[§§ 101–171] takes effect on October 1, 1992. The amendments described in such title are made on such date
and take effect on such date.
‘‘(d) PROGRAMS PROVIDING FINANCIAL ASSISTANCE.—
‘‘(1) FISCAL YEAR 1993 AND SUBSEQUENT YEARS.—In
the case of any program making awards of grants, co-

§ 236

operative agreements, or contracts, the amendments
made by this Act are effective for awards made on or
after October 1, 1992.
‘‘(2) PRIOR FISCAL YEARS.—
‘‘(A) Except as provided in subparagraph (B), in
the case of any program making awards of grants,
cooperative agreements, or contracts, if the program began operation prior to the date of the enactment of this Act [July 10, 1992] and the program
is amended by this Act, awards made prior to October 1, 1992, shall continue to be subject to the terms
and conditions upon which such awards were made,
notwithstanding the amendments made by this Act.
‘‘(B) Subparagraph (A) does not apply with respect to the amendments made by this Act to part
B of title XIX of the Public Health Service Act [section 300x et seq. of this title]. Section 205(a) [set out
as a note under section 300x of this title] applies
with respect to the program established in such
part.’’
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
in subsec. (e) of this section relating to the requirement to submit an annual report to certain committees
of Congress, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31,
Money and Finance, and page 101 of House Document
No. 103–7.
USE OF ‘‘CDC’’ AS ACRONYM FOR CENTERS FOR
DISEASE CONTROL AND PREVENTION
Section 312(i) of Pub. L. 102–531 provided that: ‘‘The
amendments made by this section [amending this section, sections 247d, 280b to 280b–2, 285c–4, 285d–7, 285m–4,
289c, 290aa–9, 290bb–1, 300u–5, 300aa–2, 300aa–19, 300aa–26,
300cc, 300cc–2, 300cc–15, 300cc–17, 300cc–20, 300cc–31,
300ee–1, 300ee–2, 300ee–31, 300ee–32, 300ee–34, 300ff–11 to
300ff–13, 300ff–17, 300ff–27, 300ff–28, 300ff–41, 300ff–43,
300ff–49, 300ff–75, 4841, and 9604 of this title, section 1341
of Title 15, Commerce and Trade, section 2001 of Title
25, Indians, and provisions set out as notes under sections 241 and 281 of this title and section 303 of Title 38,
Veterans’ Benefits] may not be construed as prohibiting the Director of the Centers for Disease Control and
Prevention from utilizing for official purposes the term
‘CDC’ as an acronym for such Centers.’’
NATIONAL COMMISSION ON ORPHAN DISEASES
Pub. L. 99–91, § 4, Aug. 15, 1985, 99 Stat. 388, as amended by Pub. L. 100–290, § 4, Apr. 18, 1988, 102 Stat. 92; Pub.
L. 102–321, title I, § 163(c)(1), July 10, 1992, 106 Stat. 376,
provided that:
‘‘(a) ESTABLISHMENT.—There is established the National Commission on Orphan Diseases (hereinafter referred to as the ‘Commission’).
‘‘(b) DUTY.—The Commission shall assess the activities of the National Institutes of Health, the Food and
Drug Administration, other public agencies, and private entities in connection with—
‘‘(1) basic research conducted on rare diseases;
‘‘(2) the use in research on rare diseases of knowledge developed in other research;
‘‘(3) applied and clinical research on the prevention,
diagnosis, and treatment of rare diseases; and
‘‘(4) the dissemination to the public, health care
professionals, researchers, and drug and medical device manufacturers of knowledge developed in research on rare diseases and other diseases which can
be used in the prevention, diagnosis, and treatment of
rare diseases.
‘‘(c) REVIEW REQUIREMENTS.—In assessing the activities of the National Institutes of Health, and the Food
and Drug Administration in connection with research
on rare diseases, the Commission shall review—
‘‘(1) the appropriateness of the priorities currently
placed on research on rare diseases;
‘‘(2) the relative effectiveness of grants and contracts when used to fund research on rare diseases;

§ 237

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(3) the appropriateness of specific requirements
applicable to applications for funds for research on
rare diseases taking into consideration the reasonable capacity of applicants to meet such requirements;
‘‘(4) the adequacy of the scientific basis for such research, including the adequacy of the research facilities and research resources used in such research and
the appropriateness of the scientific training of the
personnel engaged in such research;
‘‘(5) the effectiveness of activities undertaken to
encourage such research;
‘‘(6) the organization of the peer review process applicable to applications for funds for such research to
determine if the organization of the peer review process could be revised to improve the effectiveness of
the review provided to proposals for research on rare
diseases;
‘‘(7) the effectiveness of the coordination between
the national research institutes of the National Institutes of Health, the Food and Drug Administration,
and private entities in supporting such research; and
‘‘(8) the effectiveness of activities undertaken to assure that knowledge developed in research on nonrare
diseases is, when appropriate, used in research on
rare diseases.
‘‘(d) COMPOSITION.—The Commission shall be composed of twenty members appointed by the Secretary of
Health and Human Services as follows:
‘‘(1) Ten members shall be appointed from individuals who are not officers or employees of the Government and who by virtue of their training or experience in research on rare diseases or in the treatment
of rare diseases are qualified to serve on the Commission.
‘‘(2) Five members shall be appointed from individuals who are not officers or employees of the Government and who have a rare disease or are employed to
represent or are members of an organization concerned about rare disease.
‘‘(3) Four nonvoting members shall be appointed for
the directors of the national research institutes of
the National Institutes of Health which the Secretary
determines are involved with rare diseases.
‘‘(4) One nonvoting member shall be appointed from
officers or employees of the Food and Drug Administration who the Secretary determines are involved
with rare diseases.
A vacancy in the Commission shall be filled in the
manner in which the original appointment was made. If
any member of the Commission who was appointed to
the Commission as a director of a national research institute or as an officer or employee of the Food and
Drug Administration leaves that office or position, or
if any member of the Commission who was appointed
from persons who are not officers or employees of the
Government becomes an officer or employee of the
Government, such member may continue as a member
of the Commission for not longer than the ninety-day
period beginning on the date such member leaves that
office or position or becomes such an officer or employee, as the case may be.
‘‘(e) TERM.—Members shall be appointed for the life of
the Commission.
‘‘(f) COMPENSATION.—
‘‘(1) Except as provided in paragraph (2), members
of the Commission shall each be entitled to receive
compensation at a rate not to exceed the daily equivalent of the annual rate of basic pay in effect for
grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in
the actual performance of duties as members of the
Commission.
‘‘(2) Members of the Commission who are full-time
officers or employees of the Government shall receive
no additional pay by reason of their service on the
Commission.
‘‘(g) CHAIRMAN.—The Chairman of the Commission
shall be designated by the members of the Commission.
‘‘(h) STAFF.—Subject to such rules as may be prescribed by the Commission, the Commission may ap-

Page 96

point and fix the pay of such personnel as it determines
are necessary to enable the Commission to carry out
its functions. Personnel shall be appointed subject to
the provisions of title 5, United States Code, governing
appointments in the competitive service, and shall be
paid in accordance with the provisions of chapter 51
and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates.
‘‘(i) EXPERTS AND CONSULTANTS.—Subject to such
rules as may be prescribed by the Commission, the
Commission may procure temporary and intermittent
services under section 3109(b) of title 5 of the United
States Code, but at rates for individuals not to exceed
the daily equivalent of the basic pay payable for grade
GS–15 of the General Schedule.
‘‘(j) DETAIL OF PERSONNEL.—Upon request of the Commission, the head of any Federal agency is authorized
to detail, on a reimbursable basis, any of the personnel
of such agency to the Commission to assist the Commission in carrying out its functions.
‘‘(k) ADMINISTRATIVE SUPPORT SERVICES.—The Administrator of General Services shall provide to the
Commission on a reimbursable basis such administrative support services as the Commission may request.
‘‘(l) GENERAL AUTHORITY.—The Commission may, for
the purpose of carrying out this section, hold such
hearings, sit and act at such times and places, take
such testimony, and receive such evidence, as the Commission considers appropriate.
‘‘(m) INFORMATION.—The Commission may secure directly from any department or agency of the United
States information necessary to enable it to carry out
this section. Upon request of the Chairman, the head of
such department or agency shall furnish such information to the Commission.
‘‘(n) REPORT.—The Commission shall transmit to the
Secretary and to each House of the Congress a report
not later than February 1, 1989, on the activities of the
Commission. The report shall contain a detailed statement of the findings and conclusions of the Commission, together with its recommendations for—
‘‘(1) a long range plan for the use of public and private resources to improve research into rare diseases
and to assist in the prevention, diagnosis, and treatment of rare diseases; and
‘‘(2) such legislation or administrative actions as it
considers appropriate.
‘‘(o) TERMINATION.—The Commission shall terminate
90 days after the date of the submittal of its report
under subsection (n).
‘‘(p) FUNDS.—The Director of the National Institutes
of Health shall make available $1,000,000 to the Commission from appropriations for fiscal year 1986 for the
National Institutes of Health.’’

§ 237. Silvio O. Conte Senior Biomedical Research Service
(a) Creation; number of members
(1) There shall be in the Public Health Service
a Silvio O. Conte Senior Biomedical Research
Service, not to exceed 500 members.
(2) The authority established in paragraph (1)
regarding the number of members in the Silvio
O. Conte Senior Biomedical Research Service is
in addition to any authority established regarding the number of members in the commissioned
Regular Corps, in the Reserve Corps, and in the
Senior Executive Service. Such paragraph may
not be construed to require that the number of
members in the commissioned Regular Corps, in
the Reserve Corps, or in the Senior Executive
Service be reduced to offset the number of members serving in the Silvio O. Conte Senior Biomedical Research Service (in this section referred to as the ‘‘Service’’).

Page 97

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Appointments; qualifications; provisions inapplicable to members
The Service shall be appointed by the Secretary without regard to the provisions of title
5 regarding appointment, and shall consist of individuals outstanding in the field of biomedical
research or clinical research evaluation. No individual may be appointed to the Service unless
such individual (1) has earned a doctoral level
degree in biomedicine or a related field, and (2)
meets the qualification standards prescribed by
the Office of Personnel Management for appointment to a position at GS–15 of the General
Schedule. Notwithstanding any previous applicability to an individual who is a member of the
Service, the provisions of subchapter I of chapter 35 (relating to retention preference), chapter
43 (relating to performance appraisal and performance actions), chapter 51 (relating to classification), subchapter III of chapter 53 (relating
to General Schedule pay rates), and chapter 75
(relating to adverse actions) of title 5 shall not
apply to any member of the Service.
(c) Performance appraisal system
The Secretary shall develop a performance appraisal system designed to—
(1) provide for the systematic appraisal of
the performance of members, and
(2) encourage excellence in performance by
members.
(d) Pay of members
(1) The Secretary shall determine, subject to
the provisions of this subsection, the pay of
members of the Service.
(2) The pay of a member of the Service shall
not be less than the minimum rate payable for
GS–15 of the General Schedule and shall not exceed the rate payable for level I of the Executive
Schedule unless approved by the President
under section 5377(d)(2) of title 5.
(e) Contribution to retirement system of institutions of higher education
The Secretary may, upon the request of a
member who—
(1) performed service in the employ of an institution of higher education immediately
prior to his appointment as a member of the
Service, and
(2) retains the right to continue to make
contributions to the retirement system of
such institution,
contribute an amount not to exceed 10 percent
per annum of the member’s basic pay to such institution’s retirement system on behalf of such
member. A member who requests that such contribution be made shall not be covered by, or
earn service credit under, any retirement system established for employees of the United
States under title 5, but such service shall be
creditable for determining years of service under
section 6303(a) of such title.
(f) Career and noncareer appointment of certain
individuals
Subject to the following sentence, the Secretary may, notwithstanding the provisions of
title 5 regarding appointment, appoint an individual who is separated from the Service involuntarily and without cause to a position in the

§ 237a

competitive civil service at GS–15 of the General
Schedule, and such appointment shall be a career appointment. In the case of such an individual who immediately prior to his appointment
to the Service was not a career appointee in the
civil service or the Senior Executive Service,
such appointment shall be in the excepted civil
service and may not exceed a period of 2 years.
(g) Rules and regulations
The Secretary shall promulgate such rules and
regulations, not inconsistent with this section,
as may be necessary for the efficient administration of the Service.
(July 1, 1944, ch. 373, title II, § 228, as added Pub.
L. 101–509, title V, § 529 [title III, § 304(a)], Nov. 5,
1990, 104 Stat. 1427, 1463; amended Pub. L. 103–43,
title XX, § 2001, June 10, 1993, 107 Stat. 208.)
REFERENCES IN TEXT
The General Schedule, referred to in subsecs. (b),
(d)(2), and (f), is set out under section 5332 of Title 5,
Government Organization and Employees.
The provisions of title 5 regarding appointments, referred to in subsecs. (b) and (f), are classified to section
3301 et seq. of Title 5.
Level I of the Executive Schedule, referred to in subsec. (d)(2), is set out in section 5312 of Title 5.
AMENDMENTS
1993—Pub. L. 103–43, § 2001(b), substituted ‘‘Silvio O.
Conte Senior Biomedical Research Service’’ for ‘‘Senior
Biomedical Research Service’’ in section catchline.
Subsec. (a). Pub. L. 103–43, § 2001(a), amended subsec.
(a) generally. Prior to amendment, subsec. (a) read as
follows: ‘‘There shall be in the Public Health Service a
Senior Biomedical Research Service (hereinafter in this
section referred to as the ‘Service’), not to exceed 350
members at any time.’’
EFFECTIVE DATE
Section effective on the 90th day following Nov. 5,
1990, see section 529 [title III, § 304(c)] of Pub. L. 101–509,
set out as an Effective Date of 1990 Amendment note
under section 212 of this title.

§ 237a. Health and Human Services Office on
Women’s Health
(a) Establishment of Office
There is established within the Office of the
Secretary, an Office on Women’s Health (referred to in this section as the ‘‘Office’’). The Office shall be headed by a Deputy Assistant Secretary for Women’s Health who may report to
the Secretary.
(b) Duties
The Secretary, acting through the Office, with
respect to the health concerns of women, shall—
(1) establish short-range and long-range
goals and objectives within the Department of
Health and Human Services and, as relevant
and appropriate, coordinate with other appropriate offices on activities within the Department that relate to disease prevention, health
promotion, service delivery, research, and public and health care professional education, for
issues of particular concern to women
throughout their lifespan; 1
(2) provide expert advice and consultation to
the Secretary concerning scientific, legal, eth1 So

in original. Probably should be ‘‘lifespans;’’.

§ 237a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ical, and policy issues relating to women’s
health;
(3) monitor the Department of Health and
Human Services’ offices, agencies, and regional activities regarding women’s health
and identify needs regarding the coordination
of activities, including intramural and extramural multidisciplinary activities;
(4) establish a Department of Health and
Human Services Coordinating Committee on
Women’s Health, which shall be chaired by the
Deputy Assistant Secretary for Women’s
Health and composed of senior level representatives from each of the agencies and offices of
the Department of Health and Human Services;
(5) establish a National Women’s Health Information Center to—
(A) facilitate the exchange of information
regarding matters relating to health information, health promotion, preventive health
services, research advances, and education
in the appropriate use of health care;
(B) facilitate access to such information;
(C) assist in the analysis of issues and
problems relating to the matters described
in this paragraph; and
(D) provide technical assistance with respect to the exchange of information (including facilitating the development of materials for such technical assistance);
(6) coordinate efforts to promote women’s
health programs and policies with the private
sector; and
(7) through publications and any other
means appropriate, provide for the exchange of
information between the Office and recipients
of grants, contracts, and agreements under
subsection (c), and between the Office and
health professionals and the general public.
(c) Grants and contracts regarding duties
(1) Authority
In carrying out subsection (b), the Secretary
may make grants to, and enter into cooperative agreements, contracts, and interagency
agreements with, public and private entities,
agencies, and organizations.
(2) Evaluation and dissemination
The Secretary shall directly or through contracts with public and private entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance provided under paragraph (1) and for
the dissemination of information developed as
a result of such projects.
(d) Reports
Not later than 1 year after March 23, 2010, and
every second year thereafter, the Secretary
shall prepare and submit to the appropriate
committees of Congress a report describing the
activities carried out under this section during
the period for which the report is being prepared.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2010 through 2014.

Page 98

(July 1, 1944, ch. 373, title II, § 229, as added Pub.
L. 111–148, title III, § 3509(a)(1), Mar. 23, 2010, 124
Stat. 531.)
CONSTRUCTION
Pub. L. 111–148, title III, § 3509(j), Mar. 23, 2010, 124
Stat. 537, provided that: ‘‘Nothing in this section [enacting this section, sections 242s, 299b–24a, and 914 of
this title and section 399b of Title 21, Food and Drugs,
amending sections 287d, 290aa, 299b–25, and 299b–26 of
this title, and enacting provisions set out as notes
under this section] (or the amendments made by this
section) shall be construed to limit the authority of the
Secretary of Health and Human Services with respect
to women’s health, or with respect to activities carried
out through the Department of Health and Human
Services on the date of enactment of this section [Mar.
23, 2010].’’
TRANSFER OF FUNCTIONS
Pub. L. 111–148, title III, § 3509(a)(2), Mar. 23, 2010, 124
Stat. 533, provided that: ‘‘There are transferred to the
Office on Women’s Health (established under section
229 of the Public Health Service Act [42 U.S.C. 237a], as
added by this section), all functions exercised by the
Office on Women’s Health of the Public Health Service
prior to the date of enactment of this section [Mar. 23,
2010], including all personnel and compensation authority, all delegation and assignment authority, and all
remaining appropriations. All orders, determinations,
rules, regulations, permits, agreements, grants, contracts, certificates, licenses, registrations, privileges,
and other administrative actions that—
‘‘(A) have been issued, made, granted, or allowed to
become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions transferred under this paragraph; and
‘‘(B) are in effect at the time this section takes effect, or were final before the date of enactment of
this section and are to become effective on or after
such date,
shall continue in effect according to their terms until
modified, terminated, superseded, set aside, or revoked
in accordance with law by the President, the Secretary,
or other authorized official, a court of competent jurisdiction, or by operation of law.’’
NO NEW REGULATORY AUTHORITY
Pub. L. 111–148, title III, § 3509(h), Mar. 23, 2010, 124
Stat. 537, provided that: ‘‘Nothing in this section [enacting this section, sections 242s, 299b–24a, and 914 of
this title and section 399b of Title 21, Food and Drugs,
amending sections 287d, 290aa, 299b–25, and 299b–26 of
this title, and enacting provisions set out as notes
under this section] and the amendments made by this
section may be construed as establishing regulatory
authority or modifying any existing regulatory authority.’’
LIMITATION ON TERMINATION
Pub. L. 111–148, title III, § 3509(i), Mar. 23, 2010, 124
Stat. 537, provided that: ‘‘Notwithstanding any other
provision of law, a Federal office of women’s health (including the Office of Research on Women’s Health of
the National Institutes of Health) or Federal appointive position with primary responsibility over women’s
health issues (including the Associate Administrator
for Women’s Services under the Substance Abuse and
Mental Health Services Administration) that is in existence on the date of enactment of this section [Mar.
23, 2010] shall not be terminated, reorganized, or have
any of it’s [sic] powers or duties transferred unless such
termination, reorganization, or transfer is approved by
Congress through the adoption of a concurrent resolution of approval.’’

Page 99

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART B—MISCELLANEOUS PROVISIONS
CODIFICATION
This part was classified to subchapter XXV (§ 300aaa
et seq.) of this chapter prior to its renumbering by Pub.
L. 103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107
Stat. 213.

§ 238. Gifts for benefit of Service
(a) Acceptance by Secretary
The Secretary of Health and Human Services
is authorized to accept on behalf of the United
States gifts made unconditionally by will or
otherwise for the benefit of the Service or for
the carrying out of any of its functions. Conditional gifts may be so accepted if recommended
by the Surgeon General, and the principal of and
income from any such conditional gift shall be
held, invested, reinvested, and used in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not to be met therefrom or from the income
thereof unless such expenditure has been approved by Act of Congress.
(b) Depository of funds; availability for expenditure
Any unconditional gift of money accepted pursuant to the authority granted in subsection (a)
of this section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of this section) of any other property
so accepted, and the proceeds of insurance on
any such gift property not used for its restoration, shall be deposited in the Treasury of the
United States and are hereby appropriated and
shall be held in trust by the Secretary of the
Treasury for the benefit of the Service, and he
may invest and reinvest such funds in interestbearing obligations of the United States or in
obligations guaranteed as to both principal and
interest by the United States. Such gifts and the
income from such investments shall be available
for expenditure in the operation of the Service
and the performance of its functions, subject to
the same examination and audit as is provided
for appropriations made for the Service by Congress.
(c) Evidences of unconditional gifts of intangible
property
The evidences of any unconditional gift of intangible personal property, other than money,
accepted pursuant to the authority granted in
subsection (a) of this section shall be deposited
with the Secretary of the Treasury and he, in
his discretion, may hold them, or liquidate them
except that they shall be liquidated upon the request of the Secretary of Health and Human
Services, whenever necessary to meet payments
required in the operation of the Service or the
performance of its functions. The proceeds and
income from any such property held by the Secretary of the Treasury shall be available for expenditure as is provided in subsection (b) of this
section.
(d) Real property or tangible personal property
The Secretary of Health and Human Services
shall hold any real property or any tangible personal property accepted unconditionally pursuant to the authority granted in subsection (a) of

§ 238

this section and he shall permit such property to
be used for the operation of the Service and the
performance of its functions or he may lease or
hire such property, and may insure such property, and deposit the income thereof with the
Secretary of the Treasury to be available for expenditure as provided in subsection (b) of this
section: Provided, That the income from any
such real property or tangible personal property
shall be available for expenditure in the discretion of the Secretary of Health and Human Services for the maintenance, preservation, or repair
and insurance of such property and that any
proceeds from insurance may be used to restore
the property insured. Any such property when
not required for the operation of the Service or
the performance of its functions may be liquidated by the Secretary of Health and Human
Services, and the proceeds thereof deposited
with the Secretary of the Treasury, whenever in
his judgment the purposes of the gifts will be
served thereby.
(July 1, 1944, ch. 373, title II, § 231, formerly title
V, § 501, 58 Stat. 709; July 3, 1946, ch. 538, § 10, 60
Stat. 425; June 16, 1948, ch. 481, § 6(b), 62 Stat. 469;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 90–574, title V,
§ 503(b), Oct. 15, 1968, 82 Stat. 1012; Pub. L. 96–88,
title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; renumbered title XXI, § 2101, Pub. L. 98–24, § 2(a)(1),
Apr. 26, 1983, 97 Stat. 176; renumbered title
XXIII, § 2301, Pub. L. 99–660, title III, § 311(a),
Nov. 14, 1986, 100 Stat. 3755; renumbered title
XXV, § 2501, Pub. L. 100–607, title II, § 201(1), (2),
Nov. 4, 1988, 102 Stat. 3062; renumbered title
XXVI, § 2601, Pub. L. 100–690, title II, § 2620(a),
Nov. 18, 1988, 102 Stat. 4244; renumbered title
XXVII, § 2701, Pub. L. 101–381, title I, § 101(1), (2),
Aug. 18, 1990, 104 Stat. 576; renumbered title II,
§ 231, Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213.)
CODIFICATION
Section was formerly classified to section 300aaa of
this title prior to renumbering by Pub. L. 103–43, to section 300cc of this title prior to renumbering by Pub. L.
100–607, to section 300aa of this title prior to renumbering by Pub. L. 99–660, and to section 219 of this title
prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1968—Subsec. (e). Pub. L. 90–574 struck out subsec. (e)
which provided for acknowledgment of donations of
$50,000 or more in aid of research by the establishment
of suitable memorials within the National Institutes of
Health and the National Institute of Mental Health.
1948—Subsec. (e). Act June 16, 1948, substituted ‘‘National Institutes of Health’’ for ‘‘National Institute of
Health’’.
1946—Subsec. (e). Act July 3, 1946, inserted reference
to National Institute of Mental Health.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 238a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 238a. Use of immigration station hospitals
The Immigration and Naturalization Service
may, by agreement of the heads of the departments concerned, permit the Public Health
Service to use hospitals at immigration stations
for the care of Public Health Service patients.
The Surgeon General shall reimburse the Immigration and Naturalization Service for the actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which
reimbursement shall be covered into the proper
Immigration and Naturalization Service appropriation, or such costs may be paid from working funds established as provided by law, but no
charge shall be made for the expense of physical
upkeep of the hospitals. The Immigration and
Naturalization Service shall reimburse the Surgeon General for the care and treatment of persons detained in hospitals of the Public Health
Service at the request of the Immigration and
Naturalization Service unless such persons are
entitled to care and treatment under section
249(a) 1 of this title.
(July 1, 1944, ch. 373, title II, § 232, formerly title
V, § 502, 58 Stat. 710, renumbered title XXI, § 2102,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2302, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered title XXV, § 2502, Pub. L. 100–607, title
II, § 201(1), (2), Nov. 4, 1988, 102 Stat. 3062; renumbered title XXVI, § 2602, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2702, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 232, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
REFERENCES IN TEXT
Subsec. (a) of section 249 of this title, referred to in
text, which related to persons entitled to care and
treatment without charge, was repealed, and subsec. (c)
of section 249 of this title was redesignated as subsec.
(a), by Pub. L. 97–35, title IX, § 986(a), (b)(2), Aug. 13,
1981, 95 Stat. 603.
CODIFICATION
Section was formerly classified to section 300aaa–1 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–1 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–1 of this title prior to renumbering by Pub. L. 99–660, and to section 220 of this
title prior to renumbering by Pub. L. 98–24.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions all
agencies of or in Public Health Service transferred to
1 See

References in Text note below.

Page 100

Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of all other officers of Department of Justice and functions of all agencies and employees of such
Department, with a few exceptions, transferred to Attorney General, with power vested in him to authorize
their performance or performance of any of his functions by any of such officers, agencies, and employees,
by sections 1 and 2 of Reorg. Plan No. 2 of 1950, eff. May
24, 1950, 15 F.R. 3173, 64 Stat. 1261, which were repealed
by Pub. L. 89–554, § 8(a), Sept. 6, 1966, 80 Stat. 662. Immigration and Naturalization Service, referred to in this
section, was a bureau in Department of Justice.
ABOLITION OF IMMIGRATION AND NATURALIZATION
SERVICE AND TRANSFER OF FUNCTIONS
For abolition of Immigration and Naturalization
Service, transfer of functions, and treatment of related
references, see note set out under section 1551 of Title
8, Aliens and Nationality.

§ 238b. Disposition of money collected for care of
patients
Money collected as provided by law for expenses incurred in the care and treatment of foreign seamen, and money received for the care
and treatment of pay patients, including any
amounts received from any executive department on account of care and treatment of pay
patients, shall be covered into the appropriation
from which the expenses of such care and treatment were paid.
(July 1, 1944, ch. 373, title II, § 233, formerly title
V, § 503, 58 Stat. 710, renumbered title XXI, § 2103,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2303, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered title XXV, § 2503, Pub. L. 100–607, title
II, § 201(1), (2), Nov. 4, 1988, 102 Stat. 3062; renumbered title XXVI, § 2603, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2703, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 233, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
CODIFICATION
Section was formerly classified to section 300aaa–2 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–2 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–2 of this title prior to renumbering by Pub. L. 99–660, and to section 221 of this
title prior to renumbering by Pub. L. 98–24.

§ 238c. Transportation of remains of officers
Appropriations available for traveling expenses of the Service shall be available for meeting the cost of preparation for burial and of
transportation to the place of burial of remains
of commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations available for carrying out the provisions of this chapter shall also be available for
the payment of such expenses relating to the recovery, care and disposition of the remains of
personnel or their dependents as may be authorized under other provisions of law.
(July 1, 1944, ch. 373, title II, § 234, formerly title
V, § 506, 58 Stat. 710; July 15, 1954, ch. 507, § 14(b),

Page 101

TITLE 42—THE PUBLIC HEALTH AND WELFARE

68 Stat. 481; renumbered title XXI, § 2106, Pub. L.
98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176; renumbered title XXIII, § 2306, Pub. L. 99–660, title III,
§ 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered
title XXV, § 2504, Pub. L. 100–607, title II, § 201(1),
(3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered
title XXVI, § 2604, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2704, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 234, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
CODIFICATION
Section was formerly classified to section 300aaa–3 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–5 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–5 of this title prior to renumbering by Pub. L. 99–660, and to section 224 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1954—Act July 15, 1954, inserted sentence at end relating to availability of appropriations for paying expenses relating to recovery, care, and disposition of the
remains of personnel or their dependents.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
DISPOSITION OF REMAINS OF DECEASED PERSONNEL
Recovery, care and disposition of the remains of deceased members of the uniformed services and other deceased personnel, see section 1481 et seq. of Title 10,
Armed Forces.

§ 238d. Availability of appropriations for grants
to Federal institutions
Appropriations to the Public Health Service
available under this chapter for research, training, or demonstration project grants or for
grants to expand existing treatment and research programs and facilities for alcoholism,
narcotic addiction, drug abuse, and drug dependence and appropriations under title VI of the
Mental Health Systems Act [42 U.S.C. 9511 et
seq.] shall also be available on the same terms
and conditions as apply to non-Federal institutions, for grants for the same purpose to Federal
institutions, except that grants to Federal institutions may be funded at 100 per centum of the
costs.
(July 1, 1944, ch. 373, title II, § 235, formerly title
V, § 507, as added Pub. L. 90–31, § 5, June 24, 1967,
81 Stat. 79; amended Pub. L. 91–513, title I, § 3(c),
Oct. 27, 1970, 84 Stat. 1241; Pub. L. 94–278, title
XI, § 1102(b), Apr. 22, 1976, 90 Stat. 415; Pub. L.
96–398, title VIII, § 804(b), Oct. 7, 1980, 94 Stat.
1608; Pub. L. 97–35, title IX, § 902(g)(2), Aug. 13,
1981, 95 Stat. 560; renumbered title XXI, § 2107,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2307, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; re-

§ 238e

numbered title XXV, § 2505, Pub. L. 100–607, title
II, § 201(1), (3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered title XXVI, § 2605, Pub. L. 100–690, title
II, § 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered title XXVII, § 2705, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 235, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
REFERENCES IN TEXT
The Mental Health Systems Act, referred to in text,
is Pub. L. 96–398, Oct. 7, 1980, 94 Stat. 1564, as amended.
Title VI of the Mental Health Systems Act is classified
generally to subchapter V (§ 9511 et seq.) of chapter 102
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section
9401 of this title and Tables.
CODIFICATION
Section was formerly classified to section 300aaa–4 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–6 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–6 of this title prior to renumbering by Pub. L. 99–660, and to section 225a of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1981—Pub. L. 97–35 struck out provisions relating to
appropriations available under Community Mental
Health Centers Act for construction, etc.
1980—Pub. L. 96–398 struck out ‘‘and’’ after ‘‘drug dependence,’’ and inserted reference to title VI of the
Mental Health Systems Act.
1976—Pub. L. 94–278 substituted ‘‘Federal institutions,
except that grants to’’ for ‘‘hospitals of the Service, of
the Veterans’ Administration, or of the Bureau of Prisons of the Department of Justice, and to Saint Elizabeths Hospital, except grants to such’’.
1970—Pub. L. 91–513 inserted references to appropriations available for grants to expand existing treatment
and research programs and facilities for alcoholism,
narcotic addiction, drug abuse, and drug dependence,
and appropriations available under Community Mental
Health Centers Act for construction and staffing of
community mental health centers and alcoholism and
narcotic addiction, drug abuse, and drug dependence facilities, and inserted provision that grants to specified
Federal institutions may be funded at 100 per centum of
the costs.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see
section 902(h) of Pub. L. 97–35, set out as a note under
section 238l of this title.
EFFECTIVE DATE
Section 5 of Pub. L. 90–31 provided that this section
is effective July 1, 1968.

§ 238e. Transfer of funds
For the purpose of any reorganization under
section 203 of this title, the Secretary, with the
approval of the Director of the Office of Management and Budget, is authorized to make such
transfers of funds between appropriations as
may be necessary for the continuance of transferred functions.
(July 1, 1944, ch. 373, title II, § 236, formerly title
V, § 508, 58 Stat. 711; 1953 Reorg. Plan No. 1, §§ 5,
8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; 1970
Reorg. Plan No. 2, § 102, eff. July 1, 1970, 35 F.R.
7959, 84 Stat. 2085; renumbered title XXI, § 2108,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2308, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; re-

§ 238f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

numbered title XXV, § 2506, Pub. L. 100–607, title
II, § 201(1), (3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered title XXVI, § 2606, Pub. L. 100–690, title
II, § 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered title XXVII, § 2706, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 236, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
CODIFICATION
Section was formerly classified to section 300aaa–5 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–7 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–7 of this title prior to renumbering by Pub. L. 99–660, and to section 226 of this
title prior to renumbering by Pub. L. 98–24.
TRANSFER OF FUNCTIONS
Functions vested by law (including reorganization
plan) in Bureau of the Budget or Director of Bureau of
the Budget transferred to President of the United
States by section 101 of Reorg. Plan No. 2 of 1970, eff.
July 1, 1970, 35 F.R. 7959, 84 Stat. 2085, set out in the Appendix to Title 5, Government Organization and Employees. Section 102 of Reorg. Plan No. 2 of 1970 redesignated Bureau of the Budget as Office of Management
and Budget.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 238f. Availability of appropriations
Appropriations for carrying out the purposes
of this chapter shall be available for expenditure
for personal services and rent at the seat of Government; books of reference, periodicals, and exhibits; printing and binding; transporting in
Government-owned automotive equipment, to
and from school, children of personnel who have
quarters for themselves and their families at
stations determined by the Surgeon General to
be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who escape from any hospital, institution, or station of
the Service or from the custody of any officer or
employee of the Service, including rewards for
the capture of such prisoners; furnishing, repairing, and cleaning such wearing apparel as may
be prescribed by the Surgeon General for use by
employees in the performance of their official
duties; reimbursing officers and employees, subject to regulations of the Secretary, for the cost
of repairing or replacing their personal belongings damaged or destroyed by patients while
such officers or employees are engaged in the
performance of their official duties; and maintenance of buildings of the National Institutes of
Health.
(July 1, 1944, ch. 373, title II, § 237, formerly title
V, § 509, 58 Stat. 711; June 16, 1948, ch. 481, § 6(b),
62 Stat. 469; June 25, 1948, ch. 654, § 7, 62 Stat.
1018; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; renumbered title
XXI, § 2109, Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97

Page 102

Stat. 176; renumbered title XXIII, § 2309, Pub. L.
99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat.
3755; renumbered title XXV, § 2507, Pub. L.
100–607, title II, § 201(1), (3), Nov. 4, 1988, 102 Stat.
3062, 3063; renumbered title XXVI, § 2607, Pub. L.
100–690, title II, § 2620(a), Nov. 18, 1988, 102 Stat.
4244; renumbered title XXVII, § 2707, Pub. L.
101–381, title I, § 101(1), (2), Aug. 18, 1990, 104 Stat.
576; renumbered title II, § 237, Pub. L. 103–43,
title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat.
213.)
CODIFICATION
Section was formerly classified to section 300aaa–6 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–8 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–8 of this title prior to renumbering by Pub. L. 99–660, and to section 227 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1948—Act June 25, 1948, amended section generally to
make it apply to all appropriations to carry out the
purposes of the Service instead of merely to appropriations to carry out the research functions of the Service.
Act June 16, 1948, substituted ‘‘National Institutes of
Health’’ for ‘‘National Institute of Health’’.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
BUY AMERICAN PROVISIONS
Section 2004 of Pub. L. 103–43, as amended by Pub. L.
105–392, title IV, § 416(a), (b), Nov. 13, 1998, 112 Stat. 3590,
provided that:
‘‘(a) SENSE OF CONGRESS REGARDING PURCHASE OF
AMERICAN-MADE EQUIPMENT AND PRODUCTS.—In the
case of any equipment or product that may be authorized to be purchased with financial assistance provided
pursuant to this Act for any of the fiscal years 1994
through 1996, it is the sense of the Congress that entities receiving such assistance should, in expending the
assistance, purchase only American-made equipment
and products.
‘‘(b) NOTICE TO RECIPIENTS OF ASSISTANCE.—In providing financial assistance pursuant to this Act, the Secretary of Health and Human Services shall provide to
each recipient of the assistance a notice describing the
statement made in subsection (a) by the Congress.’’
[Pub. L. 105–392, title IV, § 416(c), Nov. 13, 1998, 112
Stat. 3591, provided that: ‘‘This section [amending section 2004 of Pub. L. 103–43, set out above] is deemed to
have taken effect immediately after the enactment of
Public Law 103–43 [June 10, 1993].’’]

Page 103

TITLE 42—THE PUBLIC HEALTH AND WELFARE

AVAILABILITY OF APPROPRIATIONS FOR ACTIVE
COMMISSIONED OFFICERS AND OTHER EXPENSES
Pub. L. 102–394, title II, § 202, Oct. 6, 1992, 106 Stat.
1810, as amended by Pub. L. 111–8, div. F, title II, § 222,
Mar. 11, 2009, 123 Stat. 784; Pub. L. 111–148, title V, § 5209,
Mar. 23, 2010, 124 Stat. 613, provided that: ‘‘Appropriations in this or any other Act or subsequent Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Acts shall
be available for expenses for active commissioned officers in the Public Health Service Reserve Corps and for
commissioned officers in the Regular Corps; expenses
incident to the dissemination of health information in
foreign countries through exhibits and other appropriate means; advances of funds for compensation, travel, and subsistence expenses (or per diem in lieu thereof) for persons coming from abroad to participate in
health or scientific activities of the Department pursuant to law; expenses of primary and secondary schooling of dependents in foreign countries, of Public Health
Service commissioned officers stationed in foreign
countries, at costs for any given area not in excess of
those of the Department of Defense for the same area,
when it is determined by the Secretary that the schools
available in the locality are unable to provide adequately for the education of such dependents, and for
the transportation of such dependents, between such
schools and their places of residence when the schools
are not accessible to such dependents by regular means
of transportation; expenses for medical care for civilian
and commissioned employees of the Public Health
Service and their dependents assigned abroad on a permanent basis in accordance with such regulations as
the Secretary may provide; rental or lease of living
quarters (for periods not exceeding five years), and provision of heat, fuel, and light and maintenance, improvement, and repair of such quarters, and advance
payments therefor, for civilian officers and employees
of the Public Health Service who are United States
citizens and who have a permanent station in a foreign
country; purchase, erection, and maintenance of temporary or portable structures; and for the payment of
compensation to consultants or individual scientists
appointed for limited periods of time pursuant to section 207(f) or section 207(g) of the Public Health Service
Act [42 U.S.C. 209(f), (g)], at rates established by the Assistant Secretary for Health, or the Secretary where
such action is required by statute, not to exceed the
per diem rate equivalent to the maximum rate payable
for senior-level positions under 5 U.S.C. 5376.’’
[Pub. L. 111–148, § 5209, which directed amendment of
Pub. L. 102–394, § 202, set out above, by striking out
‘‘not to exceed 2,800’’, was executed by striking out
‘‘not to exceed 4,000’’ before ‘‘commissioned officers in
the Regular Corps’’, to reflect the probable intent of
Congress.]
[Except as otherwise provided, reference to maximum
rate under section 5376 of Title 5, Government Organization and Employees, before first day of first pay period beginning on or after 180th day after Oct. 8, 2008,
considered reference to basic pay rate for level IV of
Executive Schedule (5 U.S.C. 5315) and reference to
maximum rate on or after first day of first pay period
beginning on or after 180th day after Oct. 8, 2008, considered reference to basic pay rate for level III of Executive Schedule (5 U.S.C. 5314), or for level II of the Executive Schedule (5 U.S.C. 5313) for certain employees,
see section 2(d)(3) of Pub. L. 110–372, set out as an Effective Date of 2008 Amendment note under section 5376 of
Title 5.]
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 102–170, title II, § 202, Nov. 26, 1991, 105 Stat.
1126.
Pub. L. 101–517, title II, § 202, Nov. 5, 1990, 104 Stat.
2208.
Pub. L. 101–166, title II, § 203, Nov. 21, 1989, 103 Stat.
1176.
Pub. L. 100–202, § 101(h) [title II, § 203], Dec. 22, 1987, 101
Stat. 1329–256, 1329–273.

§ 238g

Pub. L. 99–500, § 101(i) [H.R. 5233, title II, § 203], Oct. 18,
1986, 100 Stat. 1783–287, and Pub. L. 99–591, § 101(i) [H.R.
5233, title II, § 203], Oct. 30, 1986, 100 Stat. 3341–287.
Pub. L. 99–178, title II, § 203, Dec. 12, 1985, 99 Stat. 1118.
Pub. L. 98–619, title II, § 203, Nov. 8, 1984, 98 Stat. 3320.
Pub. L. 98–139, title II, § 203, Oct. 31, 1983, 97 Stat. 887.
Pub. L. 97–377, title I, § 101(e)(1) [title II, § 203], Dec. 21,
1982, 96 Stat. 1878, 1893.
CREDITING OF PAYMENTS FOR ROOM AND BOARD TO
APPROPRIATION ACCOUNTS
Pub. L. 102–394, title II, § 206, Oct. 6, 1992, 106 Stat.
1811, provided that: ‘‘Hereafter amounts received from
employees of the Department in payment for room and
board may be credited to the appropriation accounts
which finance the activities of the Public Health Service.’’
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 102–170, title II, § 206, Nov. 26, 1991, 105 Stat.
1126.
Pub. L. 101–517, title II, § 206, Nov. 5, 1990, 104 Stat.
2209.
Pub. L. 101–166, title II, § 207, Nov. 21, 1989, 103 Stat.
1177.

§ 238g. Wearing of uniforms
Except as may be authorized by regulations of
the President, the insignia and uniform of commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia or uniform any part of which is similar to
a distinctive part thereof, shall not be worn,
after the promulgation of such regulations, by
any person other than a commissioned officer of
the Service.
(July 1, 1944, ch. 373, title II, § 238, formerly title
V, § 510, 58 Stat. 711; June 25, 1948, ch. 645, § 5, 62
Stat. 859; renumbered title XXI, § 2110, Pub. L.
98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176; renumbered title XXIII, § 2310, Pub. L. 99–660, title III,
§ 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered
title XXV, § 2508, Pub. L. 100–607, title II, § 201(1),
(3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered
title XXVI, § 2608, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2708, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 238, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
CODIFICATION
Section was formerly classified to section 300aaa–7 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–9 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–9 of this title prior to renumbering by Pub. L. 99–660, and to section 228 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1948—Act June 25, 1948, struck out penal provisions.
See section 702 of Title 18, Crimes and Criminal Procedure.
EFFECTIVE DATE OF 1948 AMENDMENT
Amendment effective Sept. 1, 1948, see section 20 of
act June 25, 1948.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.

§ 238h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.
30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§ 238h. Biennial report
The Surgeon General shall transmit to the
Secretary, for submission to the Congress, on
January 1, 1995, and on January 1, every 2 years
thereafter, a full report of the administration of
the functions of the Service under this chapter,
including a detailed statement of receipts and
disbursements.
(July 1, 1944, ch. 373, title II, § 239, formerly title
V, § 511, 58 Stat. 711; 1953 Reorg. Plan No. 1, §§ 5,
8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; renumbered title XXI, § 2111, Pub. L. 98–24, § 2(a)(1),
Apr. 26, 1983, 97 Stat. 176; renumbered title
XXIII, § 2311, Pub. L. 99–660, title III, § 311(a),
Nov. 14, 1986, 100 Stat. 3755; renumbered title
XXV, § 2509, Pub. L. 100–607, title II, § 201(1), (3),
Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered title
XXVI, § 2609, Pub. L. 100–690, title II, § 2620(a),
Nov. 18, 1988, 102 Stat. 4244; renumbered title
XXVII, § 2709, Pub. L. 101–381, title I, § 101(1), (2),
Aug. 18, 1990, 104 Stat. 576; renumbered title II,
§ 239, Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213; Pub. L. 104–66, title
I, § 1062(a), Dec. 21, 1995, 109 Stat. 720.)
CODIFICATION
Section was formerly classified to section 300aaa–8 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–10 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–10 of this title prior to renumbering by Pub. L. 99–660, and to section 229 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1995—Pub. L. 104–66 amended section catchline and
text generally. Prior to amendment, text read as follows: ‘‘The Surgeon General shall transmit to the Secretary, for submission to the Congress at the beginning
of each regular session, a full report of the administration of the functions of the Service under this chapter,
including a detailed statement of receipts and disbursements.’’
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
of law requiring submittal to Congress of any annual,
semiannual, or other regular periodic report listed in
House Document No. 103–7 (in which item 3 on page 101
identifies a reporting provision which, as subsequently
amended, is contained in this section), see section 3003
of Pub. L. 104–66, as amended, and section 1(a)(4) [div.
A, § 1402(1)] of Pub. L. 106–554, set out as notes under
section 1113 of Title 31, Money and Finance.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

Page 104

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 202 of this title. Federal Security Agency
and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
AGENCY REPORTING REQUIREMENTS; REPORT BY SECRETARY OF HEALTH, EDUCATION, AND WELFARE TO
CONGRESSIONAL COMMITTEES RELATING TO REQUIREMENTS, TERMINATION, ETC.
Pub. L. 93–641, § 7, Jan. 4, 1975, 88 Stat. 2275, provided
that by Jan. 4, 1976, the Secretary of Health, Education,
and Welfare report to specific committees of the Senate
and the House of Representatives on the identity, due
date, etc., of certain reports required under the Public
Health Service Act, the Mental Retardation Facilities
and Community Mental Health Centers Construction
Act of 1963, or the Comprehensive Alcohol Abuse and
Alcoholism Prevention, Treatment and Rehabilitation
Act of 1970.

§ 238i. Memorials and other acknowledgments for
contributions to health of Nation
The Secretary may provide for suitably acknowledging, within the Department (whether
by memorials, designations, or other suitable
acknowledgments), (1) efforts of persons who
have contributed substantially to the health of
the Nation and (2) gifts for use in activities of
the Department related to health.
(July 1, 1944, ch. 373, title II, § 240, formerly title
V, § 512, as added Pub. L. 90–574, title V, § 503(a),
Oct. 15, 1968, 82 Stat. 1012; renumbered title XXI,
§ 2112, Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97
Stat. 176; renumbered title XXIII, § 2312, Pub. L.
99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat.
3755; renumbered title XXV, § 2510, Pub. L.
100–607, title II, § 201(1), (3), Nov. 4, 1988, 102 Stat.
3062, 3063; renumbered title XXVI, § 2610, Pub. L.
100–690, title II, § 2620(a), Nov. 18, 1988, 102 Stat.
4244; renumbered title XXVII, § 2710, Pub. L.
101–381, title I, § 101(1), (2), Aug. 18, 1990, 104 Stat.
576; renumbered title II, § 240, Pub. L. 103–43,
title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat.
213.)
CODIFICATION
Section was formerly classified to section 300aaa–9 of
this title prior to renumbering by Pub. L. 103–43, to section 300cc–11 of this title prior to renumbering by Pub.
L. 100–607, to section 300aa–11 of this title prior to renumbering by Pub. L. 99–660, and to section 229a of this
title prior to renumbering by Pub. L. 98–24.

§ 238j. Evaluation of programs
(a) In general
Such portion as the Secretary shall determine,
but not less than 0.2 percent nor more than 1
percent, of any amounts appropriated for programs authorized under this chapter shall be
made available for the evaluation (directly, or
by grants of contracts) of the implementation
and effectiveness of such programs.
(b) Report on evaluations
Not later than February 1 of each year, the
Secretary shall prepare and submit to the Com-

Page 105

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mittee on Labor and Human Resources of the
Senate and the Committee on Energy and Commerce of the House of Representatives a report
summarizing the findings of the evaluations
conducted under subsection (a) of this section.
(July 1, 1944, ch. 373, title II, § 241, formerly title
V, § 513, as added Pub. L. 91–296, title IV, § 401(a),
June 30, 1970, 84 Stat. 351; amended Pub. L.
96–398, title VIII, § 804(c), Oct. 7, 1980, 94 Stat.
1608; Pub. L. 97–35, title IX, § 902(g)(3), Aug. 13,
1981, 95 Stat. 560; renumbered title XXI, § 2113,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2313, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered title XXV, § 2511, Pub. L. 100–607, title
II, § 201(1), (3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered title XXVI, § 2611, Pub. L. 100–690, title
II, § 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered title XXVII, § 2711, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 241, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213; Pub. L.
103–183, title VII, § 701, Dec. 14, 1993, 107 Stat.
2239.)

EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see
section 902(h) of Pub. L. 97–35, set out as a note under
section 238l of this title.

§ 238k. Contract authority
The authority of the Secretary to enter into
contracts under this chapter shall be effective
for any fiscal year only to such extent or in such
amounts as are provided in advance by appropriation Acts.
(July 1, 1944, ch. 373, title II, § 242, formerly title
V, § 514, as added Pub. L. 95–623, § 11(e), Nov. 9,
1978, 92 Stat. 3456; renumbered title XXI, § 2114,
Pub. L. 98–24, § 2(a)(1), Apr. 26, 1983, 97 Stat. 176;
renumbered title XXIII, § 2314, Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered title XXV, § 2512, Pub. L. 100–607, title
II, § 201(1), (3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered title XXVI, § 2612, Pub. L. 100–690, title
II, § 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered title XXVII, § 2712, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 242, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)

CODIFICATION
Section was formerly classified to section 300aaa–10
of this title prior to renumbering by Pub. L. 103–43, to
section 300cc–12 of this title prior to renumbering by
Pub. L. 100–607, to section 300aa–12 of this title prior to
renumbering by Pub. L. 99–660, and to section 229b of
this title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1993—Pub. L. 103–183 amended section generally. Prior
to amendment, section read as follows: ‘‘Such portion
as the Secretary may determine, but not more than 1
per centum, of any appropriation for grants, contracts,
or other payments under any provision of this chapter,
the Mental Health Systems Act, the Act of August 5,
1954 (Public Law 568, Eighty–third Congress), or the Act
of August 16, 1957 (Public Law 85–151), for any fiscal
year beginning after June 30, 1970, shall be available for
evaluation (directly, or by grants or contracts) of any
program authorized by this chapter or any of such
other Acts, and, in the case of allotments from any
such appropriation, the amount available for allotment
shall be reduced accordingly.’’
1981—Pub. L. 97–35 struck out references to Mental
Retardation Facilities Construction Act and Community Mental Health Centers Act.
1980—Pub. L. 96–398 inserted reference to Mental
Health Systems Act.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1993 AMENDMENT
Section 701 of Pub. L. 103–183 provided that the
amendment made by that section is effective Oct. 1,
1994.

§ 238l

CODIFICATION
Section was formerly classified to section 300aaa–11
of this title prior to renumbering by Pub. L. 103–43, to
section 300cc–13 of this title prior to renumbering by
Pub. L. 100–607, to section 300aa–13 of this title prior to
renumbering by Pub. L. 99–660, and to section 229c of
this title prior to renumbering by Pub. L. 98–24.
OBLIGATIONS RELATED TO AGREEMENT WITH PRIVATE
ENTITIES
Pub. L. 105–277, div. A, § 101(f) [title II], Oct. 21, 1998,
112 Stat. 2681–337, 2681–349, provided in part: ‘‘That hereinafter obligations may be incurred related to agreement with private entities without receipt of advance
payment.’’

§ 238l. Recovery
(a) Right of United States to recover base
amount plus interest
If any facility with respect to which funds
have been paid under the Community Mental
Health Centers Act [42 U.S.C. 2689 et seq.] (as
such Act was in effect prior to October 1, 1981)
is, at any time within twenty years after the
completion of remodeling, construction, or expansion or after the date of its acquisition—
(1) sold or transferred to any entity (A)
which would not have been qualified to file an
application under section 222 of such Act [42
U.S.C. 2689j] (as such section was in effect
prior to October 1, 1981) or (B) which is disapproved as a transferee by the State mental
health agency or by another entity designated
by the chief executive officer of the State, or
(2) ceases to be used by a community mental
health center in the provision of comprehensive mental health services,
the United States shall be entitled to recover
from the transferor, transferee, or owner of the
facility, the base amount prescribed by subsection (c)(1) of this section plus the interest (if
any) prescribed by subsection (c)(2) of this section.
(b) Notice of sale, transfer, or change
The transferor and transferee of a facility that
is sold or transferred as described in subsection

§ 238l

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(a)(1) of this section, or the owner of a facility
the use of which changes as described in subsection (a)(2) of this section, shall provide the
Secretary written notice of such sale, transfer,
or change within 10 days after the date on which
such sale, transfer, or cessation of use occurs or
within 30 days after October 22, 1985, whichever
is later.
(c) Base amount; interest
(1) The base amount that the United States is
entitled to recover under subsection (a) of this
section is the amount bearing the same ratio to
the then value (as determined by the agreement
of the parties or in an action brought in the district court of the United States for the district
in which the facility is situated) of so much of
the facility as constituted an approved project
or projects as the amount of the Federal participation bore to the cost of the remodeling, construction, expansion, or acquisition of the
project or projects.
(2)(A) The interest that the United States is
entitled to recover under subsection (a) of this
section is the interest for the period (if any) described in subparagraph (B) at a rate (determined by the Secretary) based on the average of
the bond equivalent rates of ninety-one-day
Treasury bills auctioned during that period.
(B) The period referred to in subparagraph (A)
is the period beginning—
(i) if notice is provided as prescribed by subsection (b) of this section, 191 days after the
date on which such sale, transfer, or cessation
of use occurs, or
(ii) if notice is not provided as prescribed by
subsection (b) of this section, 11 days after
such sale, transfer, or cessation of use occurs,
and ending on the date the amount the United
States is entitled to recover is collected.
(d) Waiver of recovery rights
The Secretary may waive the recovery rights
of the United States under subsection (a) of this
section with respect to a facility (under such
conditions as the Secretary may establish by
regulation) if the Secretary determines that
there is good cause for waiving such rights.
(e) Pre-judgment lien
The right of recovery of the United States
under subsection (a) of this section shall not,
prior to judgment, constitute a lien on any facility.
(July 1, 1944, ch. 373, title II, § 243, formerly title
V, § 515, formerly Pub. L. 88–164, title II, § 225, as
added Pub. L. 94–63, title III, § 303, July 29, 1975,
89 Stat. 326; amended Pub. L. 95–622, title I,
§ 110(c), Nov. 9, 1978, 92 Stat. 3420; renumbered
title V, § 515, and amended Pub. L. 97–35, title IX,
§ 902(e)(2)(A), Aug. 13, 1981, 95 Stat. 560; renumbered title XXI, § 2115, Pub. L. 98–24, § 2(a)(1),
Apr. 26, 1983, 97 Stat. 176; Pub. L. 99–129, title II,
§ 226(a), Oct. 22, 1985, 99 Stat. 546; renumbered
title XXIII, § 2315, Pub. L. 99–660, title III,
§ 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered
title XXV, § 2513, Pub. L. 100–607, title II, § 201(1),
(3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered
title XXVI, § 2613, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2713, Pub. L. 101–381, title I,

Page 106

§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; Pub. L.
102–229, title II, § 208, Dec. 12, 1991, 105 Stat. 1716;
Pub. L. 102–239, § 1, Dec. 17, 1991, 105 Stat. 1912;
renumbered title II, § 243, Pub. L. 103–43, title
XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
REFERENCES IN TEXT
The Community Mental Health Centers Act, referred
to in subsec. (a), is title II of Pub. L. 88–164, as added
by Pub. L. 94–63, title III, § 303, July 29, 1975, 89 Stat.
309, and amended, which was classified principally to
subchapter III (§ 2689 et seq.) of chapter 33 of this title
prior to its repeal by Pub. L. 97–35, title IX,
§ 902(e)(2)(B), Aug. 13, 1981, 95 Stat. 560. Section 222 of
the Community Mental Health Centers Act was classified to section 2689j of this title prior to its repeal.
CODIFICATION
Section was classified to section 300aaa–12 of this
title prior to renumbering by Pub. L. 103–43, to section
300cc–14 of this title prior to renumbering by Pub. L.
100–607, to section 300aa–14 of this title prior to renumbering by Pub. L. 99–660, to section 229d of this title
prior to renumbering by Pub. L. 98–24, and to section
2689m of this title prior to renumbering by Pub. L.
97–35.
AMENDMENTS
1991—Subsec. (d). Pub. L. 102–229 and Pub. L. 102–239
amended subsec. (d) identically, substituting ‘‘subsection (a)’’ for ‘‘subsection (a)(2)’’.
1985—Pub. L. 99–129 amended section generally. Prior
to amendment, section read as follows: ‘‘If any facility
of a community mental health center acquired, remodeled, constructed, or expanded with funds provided
under the Community Mental Health Centers Act is, at
any time within twenty years after the completion of
such remodeling, construction, or expansion or after
the date of its acquisition with such funds—
‘‘(1) sold or transferred to any person or entity (A)
which is not qualified to file an application under
section 222 of the Community Mental Health Centers
Act, or (B) which is not approved as a transferee by
the State agency of the State in which such facility
is located, or its successor; or
‘‘(2) not used by a community mental health center
in the provision of comprehensive mental health
services, and the Secretary has not determined that
there is good cause for termination of such use,
the United States shall be entitled to recover from either the transferor or the transferee in the case of a
sale or transfer or from the owner in the case of termination of use an amount bearing the same ratio to the
then value (as determined by the agreement of the parties or by action brought in the United States district
court for the district in which the center is situated) of
so much of such facility or center as constituted an approved project or projects, as the amount of the Federal participation bore to the acquisition, remodeling,
construction, or expansion cost of such project or
projects. Such right of recovery shall not constitute a
lien upon such facility or center prior to judgment.’’
1981—Pub. L. 97–35 substituted ‘‘the Community Mental Health Centers Act’’ for ‘‘this subchapter’’ and
‘‘section 222 of the Community Mental Health Centers
Act’’ for ‘‘section 2689j of this title’’.
1978—Pub. L. 95–622 substituted ‘‘this subchapter’’ for
‘‘this part’’.
EFFECTIVE DATE OF 1985 AMENDMENT
Pub. L. 99–129, title II, § 226(b), Oct. 22, 1985, 99 Stat.
547, provided that: ‘‘In the case of any facility that was
or is constructed, remodeled, expanded, or acquired on
or before the date of enactment of this Act [Oct. 22,
1985] or within 180 days after the date of enactment of
this Act, the period described in clause (i) or (ii), as the
case may be, of section 2115(c)(2)(B) [now 243(c)(2)(B)] of
the Public Health Service Act [subsec. (c)(2)(B)(i), (ii)

Page 107

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of this section] (as amended by subsection (a) of this
section) shall begin no earlier than 181 days after the
date of enactment of this Act.’’
EFFECTIVE DATE OF 1981 AMENDMENT
Section 902(h) of Pub. L. 97–35 provided that: ‘‘The
amendments made by this section [amending this section and sections 201, 225a [now 238d], 229b [now 238j],
243, 246, 289k–1, 300d–4, 300d–6, 300l–2, 300m, 300m–3, 9412,
and 9511 of this title, repealing sections 247b–1, 247b–2,
255, 300d to 300d–3, 300d–5, 300d–7 to 300d–9, 300d–21, 2689
to 2689l, 2689n to 2689p, 2689r to 2689aa, 9411, 9421 to 9423,
9431 to 9438, 9451, 9452, 9461 to 9465, 9471 to 9473, 9481, 9491
to 9493, 9502, 9512, 9521, and 9523 of this title, repealing
provisions set out as notes under sections 246 and 2689
of this title, and transferring section 2689m to section
229d [now 238l] of this title] shall take effect October 1,
1981.’’
EFFECTIVE DATE OF 1978 AMENDMENT
Section 110(c) of Pub. L. 95–622 provided that the
amendment made by that section is effective July 29,
1975.
EFFECTIVE DATE
Section effective July 1, 1975, see section 608 of Pub.
L. 94–63, set out as an Effective Date of 1975 Amendment note under section 247b of this title.
OTHER LEGAL RIGHTS OF UNITED STATES NOT
ADVERSELY AFFECTED BY 1985 AMENDMENT
Section 226(c) of Pub. L. 99–129 provided that: ‘‘The
amendments made by subsection (a) of this section
[amending this section] shall not adversely affect other
legal rights of the United States.’’

§ 238m. Use of fiscal agents
(a) Contracting authority
The Secretary may enter into contracts with
fiscal agents—
(1)(A) to determine the amounts payable to
persons who, on behalf of the Indian Health
Service, furnish health services to eligible Indians,
(B) to determine the amounts payable to
persons who, on behalf of the Public Health
Service, furnish health services to individuals
pursuant to section 247d or 249 of this title,
(2) to receive, disburse, and account for
funds in making payments described in paragraph (1),
(3) to make such audits of records as may be
necessary to assure that these payments are
proper, and
(4) to perform such additional functions as
may be necessary to carry out the functions
described in paragraphs (1) through (3).
(b) Contracting prerequisites
(1) Contracts under subsection (a) of this section may be entered into without regard to section 6101 of title 41 or any other provision of law
requiring competition.
(2) No such contract shall be entered into with
an entity unless the Secretary finds that the entity will perform its obligations under the contract efficiently and effectively and will meet
such requirements as to financial responsibility,
legal authority, and other matters as he finds
pertinent.
(c) Advances under contracts
A contract under subsection (a) of this section
may provide for advances of funds to enable entities to make payments under the contract.

§ 238n

(d) Applicable statutory provisions
Subsections (d) and (e) 1 of section 1395u of this
title shall apply to contracts with entities under
subsection (a) of this section in the same manner as they apply to contracts with carriers
under that section.
(e) ‘‘Fiscal agent’’ defined
In this section, the term ‘‘fiscal agent’’ means
a carrier described in section 1395u(f)(1) 1 of this
title and includes, with respect to contracts
under subsection (a)(1)(A) of this section, an Indian tribe or tribal organization acting under
contract with the Secretary under the Indian
Self-Determination Act (Public Law 93–638) [25
U.S.C. 450f et seq.].
(July 1, 1944, ch. 373, title II, § 244, formerly title
XXI, § 2116, as added Pub. L. 99–272, title XVII,
§ 17003, Apr. 7, 1986, 100 Stat. 359; renumbered
title XXIII, § 2316, Pub. L. 99–660, title III,
§ 311(a), Nov. 14, 1986, 100 Stat. 3755; renumbered
title XXV, § 2514, Pub. L. 100–607, title II, § 201(1),
(3), Nov. 4, 1988, 102 Stat. 3062, 3063; renumbered
title XXVI, § 2614, Pub. L. 100–690, title II,
§ 2620(a), Nov. 18, 1988, 102 Stat. 4244; renumbered
title XXVII, § 2714, Pub. L. 101–381, title I,
§ 101(1), (2), Aug. 18, 1990, 104 Stat. 576; renumbered title II, § 244, Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213.)
REFERENCES IN TEXT
Subsections (d), (e), and (f) of section 1395u of this
title, referred to in subsecs. (d) and (e), were repealed
by Pub. L. 108–173, title IX, § 911(c)(5), Dec. 8, 2003, 117
Stat. 2384.
The Indian Self-Determination Act, referred to in
subsec. (e), is title I of Pub. L. 93–638, Jan. 4, 1975, 88
Stat. 2206, as amended, which is classified principally
to part A (§ 450f et seq.) of subchapter II of chapter 14
of Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.
CODIFICATION
In subsec. (b)(1), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
Section was classified to section 300aaa–13 of this
title prior to renumbering by Pub. L. 103–43, to section
300cc–15 of this title prior to renumbering by Pub. L.
100–607, and to section 300aa–15 of this title prior to renumbering by Pub. L. 99–660.

§ 238n. Abortion-related discrimination in governmental activities regarding training and
licensing of physicians
(a) In general
The Federal Government, and any State or
local government that receives Federal financial
assistance, may not subject any health care entity to discrimination on the basis that—
(1) the entity refuses to undergo training in
the performance of induced abortions, to require or provide such training, to perform such
abortions, or to provide referrals for such
training or such abortions;
(2) the entity refuses to make arrangements
for any of the activities specified in paragraph
(1); or
1 See

References in Text note below.

§ 238o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) the entity attends (or attended) a postgraduate physician training program, or any
other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide or refer for
training in the performance of induced abortions, or make arrangements for the provision
of such training.
(b) Accreditation of postgraduate physician
training programs
(1) In general
In determining whether to grant a legal
status to a health care entity (including a license or certificate), or to provide such entity
with financial assistance, services or other
benefits, the Federal Government, or any
State or local government that receives Federal financial assistance, shall deem accredited any postgraduate physician training program that would be accredited but for the accrediting agency’s reliance upon an accreditation standards 1 that requires an entity to perform an induced abortion or require, provide,
or refer for training in the performance of induced abortions, or make arrangements for
such training, regardless of whether such
standard provides exceptions or exemptions.
The government involved shall formulate such
regulations or other mechanisms, or enter
into such agreements with accrediting agencies, as are necessary to comply with this subsection.
(2) Rules of construction
(A) In general
With respect to subclauses (I) and (II) of
section 292d(a)(2)(B)(i) of this title (relating
to a program of insured loans for training in
the health professions), the requirements in
such subclauses regarding accredited internship or residency programs are subject to
paragraph (1) of this subsection.
(B) Exceptions
This section shall not—
(i) prevent any health care entity from
voluntarily electing to be trained, to
train, or to arrange for training in the performance of, to perform, or to make referrals for induced abortions; or
(ii) prevent an accrediting agency or a
Federal, State or local government from
establishing standards of medical competency applicable only to those individuals who have voluntarily elected to perform abortions.
(c) Definitions
For purposes of this section:
(1) The term ‘‘financial assistance’’, with respect to a government program, includes governmental payments provided as reimbursement for carrying out health-related activities.
(2) The term ‘‘health care entity’’ includes
an individual physician, a postgraduate physician training program, and a participant in a
program of training in the health professions.
(3) The term ‘‘postgraduate physician training program’’ includes a residency training
program.
1 So

in original. Probably should be ‘‘standard’’.

Page 108

(July 1, 1944, ch. 373, title II, § 245, as added Pub.
L. 104–134, title I, § 101(d) [title V, § 515], Apr. 26,
1996, 110 Stat. 1321–211, 1321–245; renumbered title
I, Pub. L. 104–140, § 1(a), May 2, 1996, 110 Stat.
1327.)
§ 238o. Restriction on use of funds for assisted
suicide, euthanasia, and mercy killing
Appropriations for carrying out the purposes
of this chapter shall not be used in a manner inconsistent with the Assisted Suicide Funding
Restriction Act of 1997 [42 U.S.C. 14401 et seq.].
(July 1, 1944, ch. 373, title II, § 246, as added Pub.
L. 105–12, § 9(e), Apr. 30, 1997, 111 Stat. 27.)
REFERENCES IN TEXT
The Assisted Suicide Funding Restriction Act of 1997,
referred to in text, is Pub. L. 105–12, Apr. 30, 1997, 111
Stat. 23, which is classified principally to chapter 138
(§ 14401 et seq.) of this title. For complete classification
of this Act to the Code, see Short Title note set out
under section 14401 of this title and Tables.
EFFECTIVE DATE
Section effective Apr. 30, 1997, and applicable to Federal payments made pursuant to obligations incurred
after Apr. 30, 1997, for items and services provided on or
after such date, subject to also being applicable with
respect to contracts entered into, renewed, or extended
after Apr. 30, 1997, as well as contracts entered into before Apr. 30, 1997, to the extent permitted under such
contracts, see section 11 of Pub. L. 105–12, set out as a
note under section 14401 of this title.

§ 238p. Recommendations and guidelines regarding automated external defibrillators for
Federal buildings
(a) Guidelines on placement
The Secretary shall establish guidelines with
respect
to
placing
automated
external
defibrillator devices in Federal buildings. Such
guidelines shall take into account the extent to
which such devices may be used by lay persons,
the typical number of employees and visitors in
the buildings, the extent of the need for security
measures regarding the buildings, buildings or
portions of buildings in which there are special
circumstances such as high electrical voltage or
extreme heat or cold, and such other factors as
the Secretary determines to be appropriate.
(b) Related recommendations
The Secretary shall publish in the Federal
Register the recommendations of the Secretary
on the appropriate implementation of the placement of automated external defibrillator devices
under subsection (a) of this section, including
procedures for the following:
(1)
Implementing
appropriate
training
courses in the use of such devices, including
the role of cardiopulmonary resuscitation.
(2) Proper maintenance and testing of the
devices.
(3) Ensuring coordination with appropriate
licensed professionals in the oversight of
training of the devices.
(4) Ensuring coordination with local emergency medical systems regarding the placement and incidents of use of the devices.
(c) Consultations; consideration of certain recommendations
In carrying out this section, the Secretary
shall—

Page 109

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) consult with appropriate public and private entities;
(2) consider the recommendations of national and local public-health organizations
for improving the survival rates of individuals
who experience cardiac arrest in nonhospital
settings by minimizing the time elapsing between the onset of cardiac arrest and the initial medical response, including defibrillation
as necessary; and
(3) consult with and counsel other Federal
agencies where such devices are to be used.
(d) Date certain for establishing guidelines and
recommendations
The Secretary shall comply with this section
not later than 180 days after November 13, 2000.
(e) Definitions
For purposes of this section:
(1)
The
term
‘‘automated
external
defibrillator device’’ has the meaning given
such term in section 238q of this title.
(2) The term ‘‘Federal building’’ includes a
building or portion of a building leased or
rented by a Federal agency, and includes
buildings on military installations of the
United States.
(July 1, 1944, ch. 373, title II, § 247, as added Pub.
L. 106–505, title IV, § 403, Nov. 13, 2000, 114 Stat.
2337.)
FINDINGS
Pub. L. 106–505, title IV, § 402, Nov. 13, 2000, 114 Stat.
2336, provided that: ‘‘Congress makes the following
findings:
‘‘(1) Over 700 lives are lost every day to sudden cardiac arrest in the United States alone.
‘‘(2) Two out of every three sudden cardiac deaths
occur before a victim can reach a hospital.
‘‘(3) More than 95 percent of these cardiac arrest
victims will die, many because of lack of readily
available life saving medical equipment.
‘‘(4) With current medical technology, up to 30 percent of cardiac arrest victims could be saved if victims had access to immediate medical response, including defibrillation and cardiopulmonary resuscitation.
‘‘(5) Once a victim has suffered a cardiac arrest,
every minute that passes before returning the heart
to a normal rhythm decreases the chance of survival
by 10 percent.
‘‘(6) Most cardiac arrests are caused by abnormal
heart rhythms called ventricular fibrillation. Ventricular fibrillation occurs when the heart’s electrical system malfunctions, causing a chaotic rhythm
that prevents the heart from pumping oxygen to the
victim’s brain and body.
‘‘(7) Communities that have implemented programs
ensuring widespread public access to defibrillators,
combined with appropriate training, maintenance,
and coordination with local emergency medical systems, have dramatically improved the survival rates
from cardiac arrest.
‘‘(8) Automated external defibrillator devices have
been demonstrated to be safe and effective, even
when used by lay people, since the devices are designed not to allow a user to administer a shock until
after the device has analyzed a victim’s heart rhythm
and determined that an electric shock is required.
‘‘(9) Increasing public awareness regarding automated external defibrillator devices and encouraging
their use in Federal buildings will greatly facilitate
their adoption.
‘‘(10) Limiting the liability of Good Samaritans and
acquirers of automated external defibrillator devices

§ 238q

in emergency situations may encourage the use of
automated external defibrillator devices, and result
in saved lives.’’
CERTAIN TECHNOLOGIES AND PRACTICES REGARDING
SURVIVAL RATES FOR CARDIAC ARREST
Pub. L. 106–129, § 7, Dec. 6, 1999, 113 Stat. 1676, provided
that: ‘‘The Secretary of Health and Human Services
shall, in consultation with the Administrator of the
General Services Administration and other appropriate
public and private entities, develop recommendations
regarding the placement of automatic external defibrillators in Federal buildings as a means of improving the survival rates of individuals who experience
cardiac arrest in such buildings, including recommendations on training, maintenance, and medical
oversight, and on coordinating with the system for
emergency medical services.’’

§ 238q. Liability regarding emergency use of
automated external defibrillators
(a) Good Samaritan protections regarding AEDs
Except as provided in subsection (b) of this
section, any person who uses or attempts to use
an automated external defibrillator device on a
victim of a perceived medical emergency is immune from civil liability for any harm resulting
from the use or attempted use of such device;
and in addition, any person who acquired the device is immune from such liability, if the harm
was not due to the failure of such acquirer of the
device—
(1) to notify local emergency response personnel or other appropriate entities of the
most recent placement of the device within a
reasonable period of time after the device was
placed;
(2) to properly maintain and test the device;
or
(3) to provide appropriate training in the use
of the device to an employee or agent of the
acquirer when the employee or agent was the
person who used the device on the victim, except that such requirement of training does
not apply if—
(A) the employee or agent was not an employee or agent who would have been reasonably expected to use the device; or
(B) the period of time elapsing between the
engagement of the person as an employee or
agent and the occurrence of the harm (or between the acquisition of the device and the
occurrence of the harm, in any case in which
the device was acquired after such engagement of the person) was not a reasonably
sufficient period in which to provide the
training.
(b) Inapplicability of immunity
Immunity under subsection (a) of this section
does not apply to a person if—
(1) the harm involved was caused by willful
or criminal misconduct, gross negligence,
reckless misconduct, or a conscious, flagrant
indifference to the rights or safety of the victim who was harmed;
(2) the person is a licensed or certified
health professional who used the automated
external defibrillator device while acting
within the scope of the license or certification
of the professional and within the scope of the
employment or agency of the professional;

§ 238q

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) the person is a hospital, clinic, or other
entity whose purpose is providing health care
directly to patients, and the harm was caused
by an employee or agent of the entity who
used the device while acting within the scope
of the employment or agency of the employee
or agent; or
(4) the person is an acquirer of the device
who leased the device to a health care entity
(or who otherwise provided the device to such
entity for compensation without selling the
device to the entity), and the harm was caused
by an employee or agent of the entity who
used the device while acting within the scope
of the employment or agency of the employee
or agent.
(c) Rules of construction
(1) In general
The following applies with respect to this
section:
(A) This section does not establish any
cause of action, or require that an automated external defibrillator device be placed
at any building or other location.
(B) With respect to a class of persons for
which this section provides immunity from
civil liability, this section supersedes the
law of a State only to the extent that the
State has no statute or regulations that provide persons in such class with immunity for
civil liability arising from the use by such
persons of automated external defibrillator
devices in emergency situations (within the
meaning of the State law or regulation involved).
(C) This section does not waive any protection from liability for Federal officers or
employees under—
(i) section 233 of this title; or
(ii) sections 1346(b), 2672, and 2679 of title
28 or under alternative benefits provided
by the United States where the availability of such benefits precludes a remedy
under section 1346(b) of title 28.
(2) Civil actions under Federal law
(A) In general
The applicability of subsections (a) and (b)
of this section includes applicability to any
action for civil liability described in subsection (a) of this section that arises under
Federal law.
(B) Federal areas adopting State law
If a geographic area is under Federal jurisdiction and is located within a State but out
of the jurisdiction of the State, and if, pursuant to Federal law, the law of the State
applies in such area regarding matters for
which there is no applicable Federal law,
then an action for civil liability described in
subsection (a) of this section that in such
area arises under the law of the State is subject to subsections (a) through (c) of this
section in lieu of any related State law that
would apply in such area in the absence of
this subparagraph.
(d) Federal jurisdiction
In any civil action arising under State law,
the courts of the State involved have jurisdic-

Page 110

tion to apply the provisions of this section exclusive of the jurisdiction of the courts of the
United States.
(e) Definitions
(1) Perceived medical emergency
For purposes of this section, the term ‘‘perceived medical emergency’’ means circumstances in which the behavior of an individual
leads a reasonable person to believe that the
individual is experiencing a life-threatening
medical condition that requires an immediate
medical response regarding the heart or other
cardiopulmonary functioning of the individual.
(2) Other definitions
For purposes of this section:
(A) The term ‘‘automated external
defibrillator device’’ means a defibrillator
device that—
(i) is commercially distributed in accordance with the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.];
(ii) is capable of recognizing the presence
or absence of ventricular fibrillation, and
is capable of determining without intervention by the user of the device whether
defibrillation should be performed;
(iii) upon determining that defibrillation
should be performed, is able to deliver an
electrical shock to an individual; and
(iv) in the case of a defibrillator device
that may be operated in either an automated or a manual mode, is set to operate
in the automated mode.
(B)(i) The term ‘‘harm’’ includes physical,
nonphysical, economic, and noneconomic
losses.
(ii) The term ‘‘economic loss’’ means any
pecuniary loss resulting from harm (including the loss of earnings or other benefits related to employment, medical expense loss,
replacement services loss, loss due to death,
burial costs, and loss of business or employment opportunities) to the extent recovery
for such loss is allowed under applicable
State law.
(iii) The term ‘‘noneconomic losses’’
means losses for physical and emotional
pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement,
loss of enjoyment of life, loss of society and
companionship, loss of consortium (other
than loss of domestic service), hedonic damages, injury to reputation and all other nonpecuniary losses of any kind or nature.
(July 1, 1944, ch. 373, title II, § 248, as added Pub.
L. 106–505, title IV, § 404, Nov. 13, 2000, 114 Stat.
2338.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (e)(2)(A)(i), is act June 25, 1938, ch. 675, 52
Stat. 1040, as amended, which is classified generally to
chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For
complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Page 111

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART C—SMALLPOX EMERGENCY PERSONNEL
PROTECTION
§ 239. General provisions
(a) Definitions
For purposes of this part:
(1) Covered countermeasure
The term ‘‘covered countermeasure’’ means
a covered countermeasure as specified in a
Declaration made pursuant to section 233(p) of
this title.
(2) Covered individual
The term ‘‘covered individual’’ means an individual—
(A) who is a health care worker, law enforcement officer, firefighter, security personnel, emergency medical personnel, other
public safety personnel, or support personnel
for such occupational specialities 1;
(B) who is or will be functioning in a role
identified in a State, local, or Department of
Health and Human Services smallpox emergency response plan (as defined in paragraph
(7)) approved by the Secretary;
(C) who has volunteered and been selected
to be a member of a smallpox emergency response plan described in subparagraph (B)
prior to the time at which the Secretary
publicly announces that an active case of
smallpox has been identified either within or
outside of the United States; and
(D) to whom a smallpox vaccine is administered pursuant to such approved plan during the effective period of the Declaration
(including the portion of such period before
April 30, 2003).
(3) Covered injury
The term ‘‘covered injury’’ means an injury,
disability, illness, condition, or death (other
than a minor injury such as minor scarring or
minor local reaction) determined, pursuant to
the procedures established under section 239a
of this title, to have been sustained by an individual as the direct result of—
(A) administration to the individual of a
covered countermeasure during the effective
period of the Declaration; or
(B) accidental vaccinia inoculation of the
individual in circumstances in which—
(i) the vaccinia is contracted during the
effective period of the Declaration or within 30 days after the end of such period;
(ii) smallpox vaccine has not been administered to the individual; and
(iii) the individual has been in contact
with an individual who is (or who was accidentally inoculated by) a covered individual.
(4) Declaration
The term ‘‘Declaration’’ means the Declaration Regarding Administration of Smallpox
Countermeasures issued by the Secretary on
January 24, 2003, and published in the Federal
Register on January 28, 2003.
(5) Effective period of the Declaration
The term ‘‘effective period of the Declaration’’ means the effective period specified in
1 So

in original. Probably should be ‘‘specialties’’.

§ 239a

the Declaration, unless extended by the Secretary.
(6) Eligible individual
The term ‘‘eligible individual’’ means an individual who is (as determined in accordance
with section 239a of this title)—
(A) a covered individual who sustains a
covered injury in the manner described in
paragraph (3)(A); or
(B) an individual who sustains a covered
injury in the manner described in paragraph
(3)(B).
(7) Smallpox emergency response plan
The term ‘‘smallpox emergency response
plan’’ or ‘‘plan’’ means a response plan detailing actions to be taken in preparation for a
possible smallpox-related emergency during
the period prior to the identification of an active case of smallpox either within or outside
the United States.
(b) Voluntary program
The Secretary shall ensure that a State, local,
or Department of Health and Human Services
plan to vaccinate individuals that is approved
by the Secretary establishes procedures to ensure, consistent with the Declaration and any
applicable guidelines of the Centers for Disease
Control and Prevention, that—
(1) potential participants are educated with
respect to contraindications, the voluntary
nature of the program, and the availability of
potential benefits and compensation under
this part;
(2) there is voluntary screening provided to
potential participants that can identify health
conditions relevant to contraindications; and
(3) there is appropriate post-inoculation
medical surveillance that includes an evaluation of adverse health effects that may reasonably appear to be due to such vaccine and
prompt referral of, or the provision of appropriate information to, any individual requiring health care as a result of such adverse
health event.
(July 1, 1944, ch. 373, title II, § 261, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 638.)
§ 239a. Determination of eligibility and benefits
(a) In general
The Secretary shall establish procedures for
determining, as applicable with respect to an individual—
(1) whether the individual is an eligible individual;
(2) whether an eligible individual has sustained a covered injury or injuries for which
medical benefits or compensation may be
available under sections 239c and 239d of this
title, and the amount of such benefits or compensation; and
(3) whether the covered injury or injuries of
an eligible individual caused the individual’s
death for purposes of benefits under section
239e of this title.
(b) Covered individuals
The Secretary may accept a certification, by a
Federal, State, or local government entity or

§ 239b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

private health care entity participating in the
administration of covered countermeasures
under the Declaration, that an individual is a
covered individual.
(c) Criteria for reimbursement
(1) Injuries specified in injury table
In any case where an injury or other adverse
effect specified in the injury table established
under section 239b of this title as a known effect of a vaccine manifests in an individual
within the time period specified in such table,
such injury or other effect shall be presumed
to have resulted from administration of such
vaccine.
(2) Other determinations
In making determinations other than those
described in paragraph (1) as to the causation
or severity of an injury, the Secretary shall
employ a preponderance of the evidence standard and take into consideration all relevant
medical and scientific evidence presented for
consideration, and may obtain and consider
the views of qualified medical experts.
(d) Deadline for filing request
The Secretary shall not consider any request
for a benefit under this part with respect to an
individual, unless—
(1) in the case of a request based on the administration of the vaccine to the individual,
the individual files with the Secretary an initial request for benefits or compensation
under this part not later than one year after
the date of administration of the vaccine; or
(2) in the case of a request based on accidental vaccinia inoculation, the individual files
with the Secretary an initial request for benefits or compensation under this part not later
than two years after the date of the first
symptom or manifestation of onset of the adverse effect.
(e) Structured settlements at Secretary’s option
In any case in which there is a reasonable
likelihood that compensation or payment under
section 239c, 239d, or 239e(b) of this title will be
required for a period in excess of one year from
the date an individual is determined eligible for
such compensation or payment, the Secretary
shall have the discretion to make a lump-sum
payment, purchase an annuity or medical insurance policy, or execute an appropriate structured settlement agreement, provided that such
payment, annuity, policy, or agreement is actuarially determined to have a value equal to the
present value of the projected total amount of
benefits or compensation that the individual is
eligible to receive under such section or sections.
(f) Review of determination
(1) Secretary’s review authority
The Secretary may review a determination
under this section at any time on the Secretary’s own motion or on application, and
may affirm, vacate, or modify such determination in any manner the Secretary deems appropriate. The Secretary shall develop a process by which an individual may file a request
for reconsideration of any determination made
by the Secretary under this section.

Page 112

(2) Judicial and administrative review
No court of the United States, or of any
State, District, territory or possession thereof,
shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any
action by the Secretary under this section. No
officer or employee of the United States shall
review any action by the Secretary under this
section (unless the President specifically directs otherwise).
(July 1, 1944, ch. 373, title II, § 262, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 640.)
§ 239b. Smallpox vaccine injury table
(a) 1 Smallpox vaccine injury table
(1) Establishment required
The Secretary shall establish by interim
final regulation a table identifying adverse effects (including injuries, disabilities, illnesses,
conditions, and deaths) that shall be presumed
to result from the administration of (or exposure to) a smallpox vaccine, and the time period in which the first symptom or manifestation of onset of each such adverse effect must
manifest in order for such presumption to
apply.
(2) Amendments
The Secretary may by regulation amend the
table established under paragraph (1). An
amendment to the table takes effect on the
date of the promulgation of the final rule that
makes the amendment, and applies to all requests for benefits or compensation under this
part that are filed on or after such date or are
pending as of such date. In addition, the
amendment applies retroactively to an individual who was not with respect to the injury
involved an eligible individual under the table
as in effect before the amendment but who
with respect to such injury is an eligible individual under the table as amended. With respect to a request for benefits or compensation
under this part by an individual who becomes
an eligible individual as described in the preceding sentence, the Secretary may not provide such benefits or compensation unless the
request (or amendment to a request, as applicable) is filed before the expiration of one year
after the effective date of the amendment to
the table in the case of an individual to whom
the vaccine was administered and before the
expiration of two years after such effective
date in the case of a request based on accidental vaccinia inoculation.
(July 1, 1944, ch. 373, title II, § 263, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 641.)
§ 239c. Medical benefits
(a) In general
Subject to the succeeding provisions of this
section, the Secretary shall make payment or
reimbursement for medical items and services
as reasonable and necessary to treat a covered
injury of an eligible individual, including the
services, appliances, and supplies prescribed or
1 So

in original. No subsec. (b) has been enacted.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

recommended by a qualified physician, which
the Secretary considers likely to cure, give relief, reduce the degree or the period of disability, or aid in lessening the amount of monthly
compensation.
(b) Benefits secondary to other coverage
Payment or reimbursement for services or
benefits under subsection (a) of this section
shall be secondary to any obligation of the
United States or any third party (including any
State or local governmental entity, private insurance carrier, or employer) under any other
provision of law or contractual agreement, to
pay for or provide such services or benefits.
(July 1, 1944, ch. 373, title II, § 264, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 641.)
§ 239d. Compensation for lost employment income
(a) In general
Subject to the succeeding provisions of this
section, the Secretary shall provide compensation to an eligible individual for loss of employment income (based on such income at the time
of injury) incurred as a result of a covered injury, at the rate specified in subsection (b) of
this section.
(b) Amount of compensation
(1) In general
Compensation under subsection (a) of this
section shall be at the rate of 662⁄3 percent of
the relevant pay period (weekly, monthly, or
otherwise), except as provided in paragraph
(2).
(2) Augmented compensation for dependents
If an eligible individual has one or more dependents, the basic compensation for loss of
employment income as described in paragraph
(1) shall be augmented at the rate of 81⁄3 percent.
(3) Consideration of other programs
(A) In general
The Secretary may consider the provisions
of sections 8114, 8115, and 8146a of title 5, and
any implementing regulations, in determining the amount of payment under subsection
(a) of this section and the circumstances
under which such payments are reasonable
and necessary.
(B) Minors
With respect to an eligible individual who
is a minor, the Secretary may consider the
provisions of section 8113 of title 5, and any
implementing regulations, in determining
the amount of payment under subsection (a)
of this section and the circumstances under
which such payments are reasonable and
necessary.
(4) Treatment of self-employment income
For purposes of this section, the term ‘‘employment income’’ includes income from selfemployment.
(c) Limitations
(1) Benefits secondary to other coverage
(A) In general
Any compensation under subsection (a) of
this section shall be secondary to the obliga-

§ 239d

tion of the United States or any third party
(including any State or local governmental
entity, private insurance carrier, or employer), under any other law or contractual
agreement, to pay compensation for loss of
employment income or to provide disability
or retirement benefits.
(B) Relation to other obligations
Compensation under subsection (a) of this
section shall not be made to an eligible individual to the extent that the total of
amounts paid to the individual under such
subsection and under the other obligations
referred to in subparagraph (A) is an amount
that exceeds the rate specified in subsection
(b)(1) of this section. If under any such other
obligation a lump-sum payment is made,
such payment shall, for purposes of this
paragraph, be deemed to be received over
multiple years rather than received in a single year. The Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple years.
(2) No benefits in case of death
No payment shall be made under subsection
(a) of this section in compensation for loss of
employment income subsequent to the receipt,
by the survivor or survivors of an eligible individual, of benefits under section 239e of this
title for death.
(3) Limit on total benefits
(A) In general
Except as provided in subparagraph (B)—
(i) total compensation paid to an individual under subsection (a) of this section
shall not exceed $50,000 for any year; and
(ii) the lifetime total of such compensation for the individual may not exceed an
amount equal to the amount authorized to
be paid under section 239e of this title.
(B) Permanent and total disability
The limitation under subparagraph (A)(ii)
does not apply in the case of an eligible individual who is determined to have a covered
injury or injuries meeting the definition of
disability in section 416(i) of this title.
(4) Waiting period
(A) In general
Except as provided in subparagraph (B), an
eligible individual shall not be provided
compensation under this section for the first
5 work days of loss of employment income.
(B) Exception
Subparagraph (A) does not apply if the period of loss of employment income of an eligible individual is 10 or more work days.
(5) Termination of benefits
No payment shall be made under subsection
(a) of this section in compensation for loss of
employment income once the eligible individual involves 1 reaches the age of 65.
(d) Benefit in addition to medical benefits
A benefit under subsection (a) of this section
shall be in addition to any amounts received by
1 So

in original. Probably should be ‘‘involved’’.

§ 239e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

an eligible individual under section 239c of this
title.
(July 1, 1944, ch. 373, title II, § 265, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 642.)
§ 239e. Payment for death
(a) Death benefit
(1) In general
The Secretary shall pay, in the case of an eligible individual whose death is determined to
have resulted from a covered injury or injuries, a death benefit in the amount determined
under paragraph (2) to the survivor or survivors in the same manner as death benefits
are paid pursuant to the Public Safety Officers’ Benefits Program under subpart 1 of part
L of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.)
with respect to an eligible deceased (except
that in the case of an eligible individual who
is a minor with no living parent, the legal
guardian shall be considered the survivor in
the place of the parent).
(2) Benefit amount
(A) In general
The amount of the death benefit under
paragraph (1) in a fiscal year shall equal the
amount of the comparable benefit calculated
under the Public Safety Officers’ Benefits
Program under subpart 1 of part L of title I
of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796 et seq.) in
such fiscal year, without regard to any reduction attributable to a limitation on appropriations, but subject to subparagraph
(B).
(B) Reduction for payments for lost employment income
The amount of the benefit as determined
under subparagraph (A) shall be reduced by
the total amount of any benefits paid under
section 239d of this title with respect to lost
employment income.
(3) Limitations
(A) In general
No benefit is payable under paragraph (1)
with respect to the death of an eligible individual if—
(i) a disability benefit is paid with respect to such individual under the Public
Safety Officers’ Benefits Program under
subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3796 et seq.); or
(ii) a death benefit is paid or payable
with respect to such individual under the
Public Safety Officers’ Benefits Program
under subpart 1 of part L of title I of the
Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3796 et seq.).
(B) Exception in the case of a limitation on
appropriations for disability benefits
under PSOB
In the event that disability benefits available to an eligible individual under the Public Safety Officers’ Benefits Program under

Page 114

subpart 1 of part L of title I of the Omnibus
Crime Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.) are reduced because of
a limitation on appropriations, and such reduction would affect the amount that would
be payable under subparagraph (A) without
regard to this subparagraph, benefits shall
be available under paragraph (1) to the extent necessary to ensure that the survivor or
survivors of such individual receives a total
amount equal to the amount described in
paragraph (2).
(b) Election in case of dependents
(1) In general
In the case of an eligible individual whose
death is determined to have resulted from a
covered injury or injuries, if the individual
had one or more dependents under the age of
18, the legal guardian of the dependents may,
in lieu of the death benefit under subsection
(a) of this section, elect to receive on behalf of
the aggregate of such dependents payments in
accordance with this subsection. An election
under the preceding sentence is effective in
lieu of a request under subsection (a) of this
section by an individual who is not the legal
guardian of such dependents.
(2) Amount of payments
Payments under paragraph (1) with respect
to an eligible individual described in such
paragraph shall be made as if such individual
were an eligible individual to whom compensation would be paid under subsection (a) of section 239d of this title, with the rate augmented
in accordance with subsection (b)(2) of such
section and with such individual considered to
be an eligible individual described in subsection (c)(3)(B) of such section.
(3) Limitations
(A) Age of dependents
No payments may be made under paragraph (1) once the youngest of the dependents involved reaches the age of 18.
(B) Benefits secondary to other coverage
(i) In general
Any payment under paragraph (1) shall
be secondary to the obligation of the
United States or any third party (including any State or local governmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to pay compensation for
loss of employment income or to provide
disability benefits, retirement benefits,
life insurance benefits on behalf of dependents under the age of 18, or death benefits.
(ii) Relation to other obligations
Payments under paragraph (1) shall not
be made to with respect to 1 an eligible individual to the extent that the total of
amounts paid with respect to the individual under such paragraph and under the
other obligations referred to in clause (i) is
an amount that exceeds the rate of payment that applies under paragraph (2). If
1 So

in original.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

under any such other obligation a lumpsum payment is made, such payment shall,
for purposes of this subparagraph, be
deemed to be received over multiple years
rather than received in a single year. The
Secretary may, in the discretion of the
Secretary, determine how to apportion
such payment over multiple years.
(c) Benefit in addition to medical benefits
A benefit under subsection (a) or (b) of this
section shall be in addition to any amounts received by an eligible individual under section
239c of this title.
(July 1, 1944, ch. 373, title II, § 266, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 643.)
REFERENCES IN TEXT
The Omnibus Crime Control and Safe Streets Act of
1968, referred to in subsec. (a)(1), (2)(A), (3), is Pub. L.
90–351, June 19, 1968, 82 Stat. 197, as amended. Subpart
1 of part L of title I of the Act is classified generally
to part A (§ 3796 et seq.) of subchapter XII of chapter 46
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section
3711 of this title and Tables.

§ 239f. Administration
(a) Administration by agreement with other
agency or agencies
The Secretary may administer any or all of
the provisions of this part through Memorandum of Agreement with the head of any appropriate Federal agency.
(b) Regulations
The head of the agency administering this
part or provisions thereof (including any agency
head administering such Act 1 or provisions
through a Memorandum of Agreement under
subsection (a) of this section) may promulgate
such implementing regulations as may be found
necessary and appropriate. Initial implementing
regulations may be interim final regulations.
(July 1, 1944, ch. 373, title II, § 267, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 645.)
§ 239g. Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2003 through 2007, to remain available
until expended, including administrative costs
and costs of provision and payment of benefits.
The Secretary’s payment of any benefit under
section 239c, 239d, or 239e of this title shall be
subject to the availability of appropriations
under this section.
(July 1, 1944, ch. 373, title II, § 268, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 645.)
§ 239h. Relationship to other laws
Except as explicitly provided herein, nothing
in this part shall be construed to override or
limit any rights an individual may have to seek
compensation, benefits, or redress under any
other provision of Federal or State law.
(July 1, 1944, ch. 373, title II, § 269, as added Pub.
L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 645.)
1 So

in original. Probably should be ‘‘part’’.

§ 239l

PART D—UNITED STATES PUBLIC HEALTH
SCIENCES TRACK
§ 239l. Establishment
(a) United States Public Health Services Track
(1) In general
There is hereby authorized to be established
a United States Public Health Sciences Track
(referred to in this part as the ‘‘Track’’), at
sites to be selected by the Secretary, with authority to grant appropriate advanced degrees
in a manner that uniquely emphasizes teambased service, public health, epidemiology, and
emergency preparedness and response. It shall
be so organized as to graduate not less than—
(A) 150 medical students annually, 10 of
whom shall be awarded studentships to the
Uniformed Services University of Health
Sciences;
(B) 100 dental students annually;
(C) 250 nursing students annually;
(D) 100 public health students annually;
(E) 100 behavioral and mental health professional students annually;
(F) 100 physician assistant or nurse practitioner students annually; and
(G) 50 pharmacy students annually.
(2) Locations
The Track shall be located at existing and
accredited, affiliated health professions education training programs at academic health
centers located in regions of the United States
determined appropriate by the Surgeon General, in consultation with the National Health
Care Workforce Commission established in
section 294q of this title.
(b) Number of graduates
Except as provided in subsection (a), the number of persons to be graduated from the Track
shall be prescribed by the Secretary. In so prescribing the number of persons to be graduated
from the Track, the Secretary shall institute actions necessary to ensure the maximum number
of first-year enrollments in the Track consistent
with the academic capacity of the affiliated
sites and the needs of the United States for medical, dental, and nursing personnel.
(c) Development
The development of the Track may be by such
phases as the Secretary may prescribe subject to
the requirements of subsection (a).
(d) Integrated longitudinal plan
The Surgeon General shall develop an integrated longitudinal plan for health professions
continuing education throughout the continuum
of health-related education, training, and practice. Training under such plan shall emphasize
patient-centered, interdisciplinary, and care coordination skills. Experience with deployment
of emergency response teams shall be included
during the clinical experiences.
(e) Faculty development
The Surgeon General shall develop faculty development programs and curricula in decentralized venues of health care, to balance urban, tertiary, and inpatient venues.
(July 1, 1944, ch. 373, title II, § 271, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
637.)

§ 239l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 239l–1. Administration
(a) In general
The business of the Track shall be conducted
by the Surgeon General with funds appropriated
for and provided by the Department of Health
and Human Services. The National Health Care
Workforce Commission shall assist the Surgeon
General in an advisory capacity.
(b) Faculty
(1) In general
The Surgeon General, after considering the
recommendations of the National Health Care
Workforce Commission, shall obtain the services of such professors, instructors, and administrative and other employees as may be necessary to operate the Track, but utilize when
possible, existing affiliated health professions
training institutions. Members of the faculty
and staff shall be employed under salary
schedules and granted retirement and other
related benefits prescribed by the Secretary so
as to place the employees of the Track faculty
on a comparable basis with the employees of
fully accredited schools of the health professions within the United States.
(2) Titles
The Surgeon General may confer academic
titles, as appropriate, upon the members of
the faculty.
(3) Nonapplication of provisions
The limitations in section 5373 of title 5
shall not apply to the authority of the Surgeon General under paragraph (1) to prescribe
salary schedules and other related benefits.
(c) Agreements
The Surgeon General may negotiate agreements with agencies of the Federal Government
to utilize on a reimbursable basis appropriate
existing Federal medical resources located in
the United States (or locations selected in accordance with section 239l(a)(2) of this title).
Under such agreements the facilities concerned
will retain their identities and basic missions.
The Surgeon General may negotiate affiliation
agreements with accredited universities and
health professions training institutions in the
United States. Such agreements may include
provisions for payments for educational services
provided students participating in Department
of Health and Human Services educational programs.
(d) Programs
The Surgeon General may establish the following educational programs for Track students:
(1) Postdoctoral, postgraduate, and technological programs.
(2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral
and mental health, public health, and nursing
students.
(3) Other programs that the Surgeon General
determines necessary in order to operate the
Track in a cost-effective manner.
(e) Continuing medical education
The Surgeon General shall establish programs
in continuing medical education for members of

Page 116

the health professions to the end that high
standards of health care may be maintained
within the United States.
(f) Authority of the Surgeon General
(1) In general
The Surgeon General is authorized—
(A) to enter into contracts with, accept
grants from, and make grants to any nonprofit entity for the purpose of carrying out
cooperative enterprises in medical, dental,
physician assistant, pharmacy, behavioral
and mental health, public health, and nursing research, consultation, and education;
(B) to enter into contracts with entities
under which the Surgeon General may furnish the services of such professional, technical, or clerical personnel as may be necessary to fulfill cooperative enterprises
undertaken by the Track;
(C) to accept, hold, administer, invest, and
spend any gift, devise, or bequest of personal
property made to the Track, including any
gift, devise, or bequest for the support of an
academic chair, teaching, research, or demonstration project;
(D) to enter into agreements with entities
that may be utilized by the Track for the
purpose of enhancing the activities of the
Track in education, research, and technological applications of knowledge; and
(E) to accept the voluntary services of
guest scholars and other persons.
(2) Limitation
The Surgeon General may not enter into any
contract with an entity if the contract would
obligate the Track to make outlays in advance
of the enactment of budget authority for such
outlays.
(3) Scientists
Scientists or other medical, dental, or nursing personnel utilized by the Track under an
agreement described in paragraph (1) may be
appointed to any position within the Track
and may be permitted to perform such duties
within the Track as the Surgeon General may
approve.
(4) Volunteer services
A person who provides voluntary services
under the authority of subparagraph (E) of
paragraph (1) shall be considered to be an employee of the Federal Government for the purposes of chapter 81 of title 5, relating to compensation for work-related injuries, and to be
an employee of the Federal Government for
the purposes of chapter 171 of title 28, relating
to tort claims. Such a person who is not otherwise employed by the Federal Government
shall not be considered to be a Federal employee for any other purpose by reason of the
provision of such services.
(July 1, 1944, ch. 373, title II, § 272, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
637.)
§ 239l–2. Students; selection; obligation
(a) Student selection
(1) In general
Medical, dental, physician assistant, pharmacy, behavioral and mental health, public

Page 117

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health, and nursing students at the Track
shall be selected under procedures prescribed
by the Surgeon General. In so prescribing, the
Surgeon General shall consider the recommendations of the National Health Care Workforce Commission.
(2) Priority
In developing admissions procedures under
paragraph (1), the Surgeon General shall ensure that such procedures give priority to applicant medical, dental, physician assistant,
pharmacy, behavioral and mental health, public health, and nursing students from rural
communities and underrepresented minorities.
(b) Contract and service obligation
(1) Contract
Upon being admitted to the Track, a medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, or
nursing student shall enter into a written contract with the Surgeon General that shall contain—
(A) an agreement under which—
(i) subject to subparagraph (B), the Surgeon General agrees to provide the student
with tuition (or tuition remission) and a
student stipend (described in paragraph
(2)) in each school year for a period of
years (not to exceed 4 school years) determined by the student, during which period
the student is enrolled in the Track at an
affiliated or other participating health
professions institution pursuant to an
agreement between the Track and such institution; and
(ii) subject to subparagraph (B), the student agrees—
(I) to accept the provision of such tuition and student stipend to the student;
(II) to maintain enrollment at the
Track until the student completes the
course of study involved;
(III) while enrolled in such course of
study, to maintain an acceptable level of
academic standing (as determined by the
Surgeon General);
(IV) if pursuing a degree from a school
of medicine or osteopathic medicine,
dental, public health, or nursing school
or a physician assistant, pharmacy, or
behavioral and mental health professional program, to complete a residency
or internship in a specialty that the Surgeon General determines is appropriate;
and
(V) to serve for a period of time (referred to in this part as the ‘‘period of
obligated service’’) within the Commissioned Corps of the Public Health Service equal to 2 years for each school year
during which such individual was enrolled at the College, reduced as provided
for in paragraph (3);
(B) a provision that any financial obligation of the United States arising out of a
contract entered into under this part and
any obligation of the student which is conditioned thereon, is contingent upon funds
being appropriated to carry out this part;

§ 239l–2

(C) a statement of the damages to which
the United States is entitled for the student’s breach of the contract; and
(D) such other statements of the rights
and liabilities of the Secretary and of the individual, not inconsistent with the provisions of this part.
(2) Tuition and student stipend
(A) Tuition remission rates
The Surgeon General, based on the recommendations of the National Health Care
Workforce Commission, shall establish Federal tuition remission rates to be used by
the Track to provide reimbursement to affiliated and other participating health professions institutions for the cost of educational services provided by such institutions to Track students. The agreement entered into by such participating institutions
under paragraph (1)(A)(i) shall contain an
agreement to accept as payment in full the
established remission rate under this subparagraph.
(B) Stipend
The Surgeon General, based on the recommendations of the National Health Care
Workforce Commission, shall establish and
update Federal stipend rates for payment to
students under this part.
(3) Reductions in the period of obligated service
The period of obligated service under paragraph (1)(A)(ii)(V) shall be reduced—
(A) in the case of a student who elects to
participate in a high-needs speciality residency (as determined by the National Health
Care Workforce Commission), by 3 months
for each year of such participation (not to
exceed a total of 12 months); and
(B) in the case of a student who, upon completion of their residency, elects to practice
in a Federal medical facility (as defined in
section 781(e)) 1 that is located in a health
professional shortage area (as defined in section 254e of this title), by 3 months for year 2
of full-time practice in such a facility (not
to exceed a total of 12 months).
(c) Second 2 years of service
During the third and fourth years in which a
medical, dental, physician assistant, pharmacy,
behavioral and mental health, public health, or
nursing student is enrolled in the Track, training should be designed to prioritize clinical rotations in Federal medical facilities in health professional shortage areas, and emphasize a balance of hospital and community-based experiences, and training within interdisciplinary
teams.
(d) Dentist, physician assistant, pharmacist, behavioral and mental health professional,
public health professional, and nurse training
The Surgeon General shall establish provisions applicable with respect to dental, physi1 So
2 So

in original. Act July 1, 1944, does not contain a section 781.
in original. Probably should be preceded by ‘‘each’’.

§ 239l–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cian assistant, pharmacy, behavioral and mental
health, public health, and nursing students that
are comparable to those for medical students
under this section, including service obligations,
tuition support, and stipend support. The Surgeon General shall give priority to health professions training institutions that train medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, and
nursing students for some significant period of
time together, but at a minimum have a discrete and shared core curriculum.
(e) Elite Federal disaster teams
The Surgeon General, in consultation with the
Secretary, the Director of the Centers for Disease Control and Prevention, and other appropriate military and Federal government agencies, shall develop criteria for the appointment
of highly qualified Track faculty, medical, dental, physician assistant, pharmacy, behavioral
and mental health, public health, and nursing
students, and graduates to elite Federal disaster
preparedness teams to train and to respond to
public health emergencies, natural disasters,
bioterrorism events, and other emergencies.
(f) Student dropped from Track in affiliate
school
A medical, dental, physician assistant, pharmacy, behavioral and mental health, public
health, or nursing student who, under regulations prescribed by the Surgeon General, is
dropped from the Track in an affiliated school
for deficiency in conduct or studies, or for other
reasons, shall be liable to the United States for
all tuition and stipend support provided to the
student.
(July 1, 1944, ch. 373, title II, § 273, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
639.)
§ 239l–3. Funding
Beginning with fiscal year 2010, the Secretary
shall transfer from the Public Health and Social
Services Emergency Fund such sums as may be
necessary to carry out this part.
(July 1, 1944, ch. 373, title II, § 274, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
642.)
SUBCHAPTER II—GENERAL POWERS AND
DUTIES
PART A—RESEARCH AND INVESTIGATIONS
§ 241. Research and investigations generally
(a) Authority of Secretary
The Secretary shall conduct in the Service,
and encourage, cooperate with, and render assistance to other appropriate public authorities,
scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of
physical and mental diseases and impairments
of man, including water purification, sewage
treatment, and pollution of lakes and streams.
In carrying out the foregoing the Secretary is
authorized to—

Page 118

(1) collect and make available through publications and other appropriate means, information as to, and the practical application of,
such research and other activities;
(2) make available research facilities of the
Service to appropriate public authorities, and
to health officials and scientists engaged in
special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such
research projects as are recommended by the
advisory council to the entity of the Department supporting such projects and make, upon
recommendation of the advisory council to the
appropriate entity of the Department, grantsin-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for
the general support of their research;
(4) secure from time to time and for such periods as he deems advisable, the assistance and
advice of experts, scholars, and consultants
from the United States or abroad;
(5) for purposes of study, admit and treat at
institutions, hospitals, and stations of the
Service, persons not otherwise eligible for
such treatment;
(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application
of statistical methods to experiments, studies,
and surveys in health and medical fields;
(7) enter into contracts, including contracts
for research in accordance with and subject to
the provisions of law applicable to contracts
entered into by the military departments
under sections 2353 and 2354 of title 10, except
that determination, approval, and certification required thereby shall be by the Secretary of Health and Human Services; and
(8) adopt, upon recommendations of the advisory councils to the appropriate entities of
the Department or, with respect to mental
health, the National Advisory Mental Health
Council, such additional means as the Secretary considers necessary or appropriate to
carry out the purposes of this section.
The Secretary may make available to individuals and entities, for biomedical and behavioral
research, substances and living organisms. Such
substances and organisms shall be made available under such terms and conditions (including
payment for them) as the Secretary determines
appropriate.
(b) Testing for carcinogenicity, teratogenicity,
mutagenicity, and other harmful biological
effects; consultation
(1) The Secretary shall conduct and may support through grants and contracts studies and
testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph,
the Secretary shall consult with entities of the
Federal Government, outside of the Department
of Health and Human Services, engaged in comparable activities. The Secretary, upon request
of such an entity and under appropriate arrangements for the payment of expenses, may conduct
for such entity studies and testing of substances

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
(2)(A) The Secretary shall establish a comprehensive program of research into the biological
effects of low-level ionizing radiation under
which program the Secretary shall conduct such
research and may support such research by others through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of Federal programs of research on
the biological effects of ionizing radiation.
(3) The Secretary shall conduct and may support through grants and contracts research and
studies on human nutrition, with particular emphasis on the role of nutrition in the prevention
and treatment of disease and on the maintenance and promotion of health, and programs
for the dissemination of information respecting
human nutrition to health professionals and the
public. In carrying out activities under this
paragraph, the Secretary shall provide for the
coordination of such of these activities as are
performed by the different divisions within the
Department of Health and Human Services and
shall consult with entities of the Federal Government, outside of the Department of Health
and Human Services, engaged in comparable activities. The Secretary, upon request of such an
entity and under appropriate arrangements for
the payment of expenses, may conduct and support such activities for such entity.
(4) The Secretary shall publish a biennial report which contains—
(A) a list of all substances (i) which either
are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii)
to which a significant number of persons residing in the United States are exposed;
(B) information concerning the nature of
such exposure and the estimated number of
persons exposed to such substances;
(C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or
exposure standard has been established by a
Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a
Federal agency with respect to a substance
contained in the list under subparagraph (A),
the extent to which, on the basis of available
medical, scientific, or other data, such standard, and the implementation of such standard
by the agency, decreases the risk to public
health from exposure to the substance; and
(D) a description of (i) each request received
during the year involved—
(I) from a Federal agency outside the Department of Health and Human Services for
the Secretary, or
(II) from an entity within the Department
of Health and Human Services to any other
entity within the Department,
to conduct research into, or testing for, the
carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each
such other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter
into any contract for the conduct of any study,

§ 241

testing, program, research, or review, or assessment under this subsection shall be effective for
any fiscal year only to such extent or in such
amounts as are provided in advance in appropriation Acts.
(c) Diseases not significantly occurring in United
States
The Secretary may conduct biomedical research, directly or through grants or contracts,
for the identification, control, treatment, and
prevention of diseases (including tropical diseases) which do not occur to a significant extent
in the United States.
(d) Protection of privacy of individuals who are
research subjects
The Secretary may authorize persons engaged
in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol
and other psychoactive drugs) to protect the privacy of individuals who are the subject of such
research by withholding from all persons not
connected with the conduct of such research the
names or other identifying characteristics of
such individuals. Persons so authorized to protect the privacy of such individuals may not be
compelled in any Federal, State, or local civil,
criminal, administrative, legislative, or other
proceedings to identify such individuals.
(e) Preterm labor and delivery and infant mortality
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall expand, intensify, and coordinate the activities of the Centers for Disease Control and
Prevention with respect to preterm labor and
delivery and infant mortality.
(July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691;
July 3, 1946, ch. 538, § 7(a), (b), 60 Stat. 423; June
16, 1948, ch. 481, § 4(e), (f), 62 Stat. 467; June 24,
1948, ch. 621, § 4(e), (f), 62 Stat. 601; June 25, 1948,
ch. 654, § 1, 62 Stat. 1017; July 3, 1956, ch. 510, § 4,
70 Stat. 490; Pub. L. 86–798, Sept. 15, 1960, 74 Stat.
1053; Pub. L. 87–838, § 2, Oct. 17, 1962, 76 Stat. 1073;
Pub. L. 89–115, § 3, Aug. 9, 1965, 79 Stat. 448; Pub.
L. 90–174, § 9, Dec. 5, 1967, 81 Stat. 540; Pub. L.
91–513, title I, § 3(a), Oct. 27, 1970, 84 Stat. 1241;
Pub. L. 91–515, title II, § 292, Oct. 30, 1970, 84 Stat.
1308; Pub. L. 92–218, § 6(a)(2), Dec. 23, 1971, 85
Stat. 785; Pub. L. 92–423, § 7(b), Sept. 19, 1972, 86
Stat. 687; Pub. L. 93–282, title I, § 122(b), May 14,
1974, 88 Stat. 132; Pub. L. 93–348, title I,
§ 104(a)(1), July 12, 1974, 88 Stat. 346; Pub. L.
93–352, title I, § 111, July 23, 1974, 88 Stat. 360;
Pub. L. 94–278, title I, § 111, Apr. 22, 1976, 90 Stat.
405; Pub. L. 95–622, title II, §§ 261, 262, Nov. 9, 1978,
92 Stat. 3434; Pub. L. 96–88, title V, § 509(b), Oct.
17, 1979, 93 Stat. 695; Pub. L. 99–158, § 3(a)(5), Nov.
20, 1985, 99 Stat. 879; Pub. L. 99–570, title IV,
§ 4021(b)(2), Oct. 27, 1986, 100 Stat. 3207–124; Pub.
L. 99–660, title I, § 104, Nov. 14, 1986, 100 Stat.
3751; Pub. L. 100–607, title I, § 163(1), (2), Nov. 4,
1988, 102 Stat. 3062; Pub. L. 103–43, title XX,
§ 2009, June 10, 1993, 107 Stat. 213; Pub. L. 109–450,
§ 3(a), Dec. 22, 2006, 120 Stat. 3341.)
AMENDMENTS
2006—Subsec. (e). Pub. L. 109–450 added subsec. (e).
1993—Subsec. (b)(4). Pub. L. 103–43 substituted ‘‘a biennial report’’ for ‘‘an annual report’’ in introductory
provisions.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

1988—Subsec. (d). Pub. L. 100–607 redesignated concluding provisions of subsec. (a) of section 242a of this
title as subsec. (d) of this section, substituted ‘‘biomedical, behavioral, clinical, or other research (including research on mental health, including’’ for ‘‘research
on mental health, including’’, and substituted ‘‘drugs)’’
for ‘‘drugs,’’.
1986—Subsec. (a)(3). Pub. L. 99–570 struck out ‘‘or, in
the case of mental health projects, by the National Advisory Mental Health Council;’’ after ‘‘Department supporting such projects’’ and struck out ‘‘or the National
Advisory Mental Health Council’’ after ‘‘appropriate
entity of the Department’’.
Subsec. (c). Pub. L. 99–660 added subsec. (c).
1985—Subsec. (a)(3). Pub. L. 99–158, § 3(a)(5)(A), substituted ‘‘as are recommended by the advisory council
to the entity of the Department supporting such
projects or, in the case of mental health projects, by
the National Advisory Mental Health Council; and
make, upon recommendation of the advisory council to
the appropriate entity of the Department or the National Advisory Mental Health Council, grants-in-aid
to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of
their research’’ for ‘‘as are recommended by the National Advisory Health Council, or, with respect to cancer, recommended by the National Cancer Advisory
Board, or, with respect to mental health, recommended
by the National Advisory Mental Health Council, or
with respect to heart, blood vessel, lung, and blood diseases and blood resources, recommended by the National Heart, Lung, and Blood Advisory Council, or,
with respect to dental diseases and conditions, recommended by the National Advisory Dental Research
Council; and include in the grants for any such project
grants of penicillin and other antibiotic compounds for
use in such project; and make, upon recommendation of
the National Advisory Health Council, grants-in-aid to
public or nonprofit universities, hospitals, laboratories,
and other institutions for the general support of their
research: Provided, That such uniform percentage, not
to exceed 15 per centum, as the Secretary may determine, of the amounts provided for grants for research
projects for any fiscal year through the appropriations
for the National Institutes of Health may be transferred from such appropriations to a separate account
to be available for such research grants-in-aid for such
fiscal year’’.
Subsec. (a)(8). Pub. L. 99–158, § 3(a)(5)(B), substituted
‘‘recommendations of the advisory councils to the appropriate entities of the Department or, with respect to
mental health, the National Advisory Mental Health
Council, such additional means as the Secretary considers’’ for ‘‘recommendation of the National Advisory
Health Council, or, with respect to cancer, upon recommendation of the National Cancer Advisory Board, or,
with respect to mental health, upon recommendation of
the National Advisory Mental Health Council, or, with
respect to heart, blood vessel, lung, and blood diseases
and blood resources, upon recommendation of the National Heart, Lung and Blood Advisory Council, or,
with respect to dental diseases and conditions, upon
recommendations of the National Advisory Dental Research Council, such additional means as he deems’’.
1978—Pub. L. 95–622 designated existing provisions as
subsec. (a), redesignated former pars. (a) to (h) as (1) to
(8), respectively, substituted ‘‘Secretary’’ for ‘‘Surgeon
General’’ wherever appearing, and inserted following
par. (8) provisions relating to authority of Secretary to
make available to individuals and entities substances
and living organisms, and added subsec. (b).
1976—Subsecs. (c), (h). Pub. L. 94–278 substituted
‘‘heart, blood vessel, lung, and blood diseases and blood
resources’’ for ‘‘heart diseases’’ and ‘‘National Heart,
Lung and Blood Advisory Council’’ for ‘‘National Heart
and Lung Advisory Council’’.
1974—Subsec. (c). Pub. L. 93–348, § 104(a)(1), redesignated subsec. (d) as (c) and substituted ‘‘research
projects’’ for ‘‘research or research training projects’’
in two places, ‘‘general support of their research’’ for

Page 120

‘‘general support of their research and research training programs’’ and ‘‘research grants-in-aid’’ for ‘‘research and research training program grants-in-aid’’.
Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public
Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may
deem necessary to procure the assistance of the most
brilliant and promising research fellows from the
United States and abroad, was struck out.
Subsec. (d). Pub. L. 93–348, § 104(a)(1)(C), redesignated
subsec. (e) as (d).
Pub. L. 93–282 substituted ‘‘mental health, including
research on the use and effect of alcohol and other
psychoactive drugs’’ for ‘‘the use and effect of drugs’’ in
former concluding provisions of section 242a(a) of this
title. See 1988 Amendment note above.
Subsecs. (e), (f). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (f) and (g) as (e) and (f), respectively.
Former subsec. (e) redesignated (d).
Subsec. (g). Pub. L. 93–352 struck out ‘‘during the fiscal year ending June 30, 1966, and each of the eight succeeding fiscal years’’ after ‘‘Enter into contracts’’. Notwithstanding directory language that amendment be
made to subsec. (h), the amendment was executed to
subsec. (g) to reflect the probable intent of Congress
and the intervening redesignation of subsec. (h) as (g)
by Pub. L. 93–348.
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (h)
as (g). Former subsec. (g) redesignated (f).
Subsecs. (h), (i). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (h) and (i) as (g) and (h), respectively.
1972—Subsecs. (d), (i). Pub. L. 92–423 substituted ‘‘National Heart and Lung Advisory Council’’ for ‘‘National
Advisory Heart Council’’.
1971—Subsecs. (d), (i). Pub. L. 92–218 substituted ‘‘National Cancer Advisory Board’’ for ‘‘National Advisory
Cancer Council’’.
1970—Subsec. (d). Pub. L. 91–513 added subsec. (d). See
1988 Amendment note above.
Subsec. (h). Pub. L. 91–515 substituted ‘‘eight’’ for
‘‘five’’ succeeding fiscal years.
1967—Subsec. (h). Pub. L. 90–174 substituted ‘‘five’’ for
‘‘two’’ succeeding fiscal years.
1965—Subsecs. (h), (i). Pub. L. 89–115 added subsec. (h)
and redesignated former subsec. (h) as (i).
1962—Subsec. (d). Pub. L. 87–838 inserted ‘‘or research
training’’ in two places.
1960—Subsec. (d). Pub. L. 86–798 authorized the Surgeon General, upon recommendation of the National
Advisory Health Council, to make grants to public or
non-profit universities, hospitals, laboratories, and
other institutions to support research and research
training programs, and to make available for such research and research training programs, up to 15 per
centum of amounts provided for research grants
through the appropriations for the National Institutes
of Health.
1956—Subsecs. (g), (h). Act July 3, 1956, added subsec.
(g) and redesignated former subsec. (g) as (h).
1948—Subsec. (d). Acts June 16, 1948, § 4(e), and June
24, 1948, § 4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other
antibiotic compounds for use in research projects.
Subsec. (g). Acts June 16, 1948, § 4(f), and June 24, 1948,
§ 4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental
Research Council, respectively.
1946—Subsec. (d). Act July 3, 1946, made the National
Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of
grants-in-aid for research projects with respect to mental health.
Subsec. (g). Act July 3, 1946, gave National Advisory
Health Council the right to make recommendations to
carry out purposes of this section.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
CHANGE OF NAME

‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a)(7), and ‘‘Department of Health and
Human Services’’ substituted for ‘‘Department of
Health, Education, and Welfare’’ in subsec. (b)(1), (3),
and (4)(D)(I), (II), pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
EFFECTIVE DATE OF 1978 AMENDMENT
Sections 261 and 262 of Pub. L. 95–622 provided that
the amendments made by those sections are effective
Oct. 1, 1978.

§ 241

ganizations with expertise in preventing such practice.
‘‘(3) Develop recommendations for the education of
students of schools of medicine and osteopathic medicine regarding female genital mutilation and complications arising from such mutilation. Such recommendations shall be disseminated to such schools.
‘‘(c) For purposes of this section the term ‘female
genital mutilation’ means the removal or infibulation
(or both) of the whole or part of the clitoris, the labia
minor, or the labia major.
‘‘(d) The Secretary of Health and Human Services
shall commence carrying out this section not later
than 90 days after the date of enactment of this Act
[Apr. 26, 1996].’’

EFFECTIVE DATE OF 1974 AMENDMENT
Section 104(b) of Pub. L. 93–348 provided that: ‘‘The
amendments made by subsection (a) [amending this
section and sections 242a, 282, 286a, 286b, 287a, 287b, 287d,
288a, 289c, 289c–1, 289g, 289k, and heading preceding section 289l of this title] shall not apply with respect to
commitments made before the date of the enactment of
this Act [July 12, 1974] by the Secretary of Health, Education, and Welfare for research training under the provisions of the Public Health Service Act amended or repealed by subsection (a).’’
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92–423 effective 60 days after
Sept. 19, 1972, or on such prior date after Sept. 19, 1972,
as the President shall prescribe and publish in the Federal Register, see section 9 of Pub. L. 92–423, set out as
a note under section 218 of this title.
EFFECTIVE DATE OF 1971 AMENDMENT
Amendment by Pub. L. 92–218 effective 60 days after
Dec. 23, 1971, or on such prior date after Dec. 23, 1971,
as the President shall prescribe and publish in the Federal Register, see section 7 of Pub. L. 92–218, set out as
a note under section 218 of this title.
COORDINATION OF DATA SURVEYS AND REPORTS
Pub. L. 106–113, div. B, § 1000(a)(6) [title VII, § 703(e)],
Nov. 29, 1999, 113 Stat. 1536, 1501A–402, provided that:
‘‘The Secretary of Health and Human Services, through
the Assistant Secretary for Planning and Evaluation,
shall establish a clearinghouse for the consolidation
and coordination of all Federal databases and reports
regarding children’s health.’’
FEMALE GENITAL MUTILATION
Pub. L. 104–134, title I, § 101(d) [title V, § 520], Apr. 26,
1996, 110 Stat. 1321–211, 1321–250; renumbered title I,
Pub. L. 104–140, § 1(a), May 2, 1996, 110 Stat. 1327, provided that:
‘‘(a) Congress finds that—
‘‘(1) the practice of female genital mutilation is
carried out by members of certain cultural and religious groups within the United States; and
‘‘(2) the practice of female genital mutilation often
results in the occurrence of physical and psychological health effects that harm the women involved.
‘‘(b) The Secretary of Health and Human Services
shall do the following:
‘‘(1) Compile data on the number of females living
in the United States who have been subjected to female genital mutilation (whether in the United
States or in their countries of origin), including a
specification of the number of girls under the age of
18 who have been subjected to such mutilation.
‘‘(2) Identify communities in the United States that
practice female genital mutilation, and design and
carry out outreach activities to educate individuals
in the communities on the physical and psychological
health effects of such practice. Such outreach activities shall be designed and implemented in collaboration with representatives of the ethnic groups practicing such mutilation and with representatives of or-

SENTINEL DISEASE CONCEPT STUDY
Section 1910 of Pub. L. 103–43 directed Secretary of
Health and Human Services, in cooperation with Agency for Toxic Substances and Disease Registry and Centers for Disease Control and Prevention, to design and
implement a pilot sentinel disease surveillance system
for identifying relationship between occupation of
household members and incidence of subsequent conditions or diseases in other members of household, and
required Director of the National Institutes of Health
to prepare and submit to Congress, not later than 4
years after June 10, 1993, a report concerning this
project.
STUDY OF THYROID MORBIDITY FOR HANFORD,
WASHINGTON
Section 161 of Pub. L. 100–607, as amended by Pub. L.
102–531, title III, § 312(e)(1), Oct. 27, 1992, 106 Stat. 3506,
directed Secretary of Health and Human Services, acting through Director of Centers for Disease Control and
Prevention, to conduct a study of thyroid morbidity of
the population, including Indian tribes and tribal organizations, in vicinity of Hanford, in State of Washington, authorized Director to contract out portions of
study, and required Director, not later than 42 months
after Nov. 4, 1988, to transmit a report, including such
study, to Congress, chief executive officers of States of
Oregon and Washington, and governing officials of Indian tribes in vicinity of Hanford, Washington.
NATIONAL COMMISSION ON SLEEP DISORDERS RESEARCH
Section 162 of Pub. L. 100–607 directed Secretary of
Health and Human Services, after consultation with
Director of National Institutes of Health, to establish
a National Commission on Sleep Disorders Research to
conduct a comprehensive study of present state of
knowledge of incidence, prevalence, morbidity, and
mortality resulting from sleep disorders, and of social
and economic impact of such disorders, evaluate public
and private facilities and resources (including trained
personnel and research activities) available for diagnosis, prevention, and treatment of, and research into,
such disorders, and identify programs (including biological, physiological, behavioral, environmental, and
social programs) by which improvement in management and research into sleep disorders could be accomplished and, not later than 18 months after initial
meeting of Commission, to submit to appropriate Committees of Congress a final report, and provided for termination of the Commission 30 days after submission of
final report.
RESEARCH WITH RESPECT TO HEALTH RESOURCES AND
SERVICES ADMINISTRATION
Section 632 of Pub. L. 100–607 provided that with respect to any program of research pursuant to this chapter, any such program carried out in fiscal year 1987 by
an agency other than Health Resources and Services
Administration (or appropriate to be carried out by

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

such an agency) could not, for each of fiscal years 1989
through 1991, be carried out by such Administration.
CONTINUING CARE FOR PSYCHIATRIC PATIENTS IN
FORMER CLINICAL RESEARCH CENTER AT NATIONAL
INSTITUTE ON DRUG ABUSE
Pub. L. 99–117, § 10, Oct. 7, 1985, 99 Stat. 494, provided
that: ‘‘In any fiscal year beginning after September 30,
1981, from funds appropriated for carrying out section
301 of the Public Health Service Act [this section] with
respect to mental health, the Secretary of Health and
Human Services may provide, by contract or otherwise,
for the continuing care of psychiatric patients who
were under active and continuous treatment at the National Institute on Drug Abuse Clinical Research Center on the date such Clinical Research Center ceased
operations.’’
ANALYSIS OF THYROID CANCER; CREATION AND
PUBLICATION OF RADIOEPIDEMIOLOGICAL TABLES
Pub. L. 97–414, § 7, Jan. 4, 1983, 96 Stat. 2059, as amended by Pub. L. 109–482, title I, § 104(b)(3)(A), Jan. 15, 2007,
120 Stat. 3694, provided that:
‘‘(a) In carrying out section 301 of the Public Health
Service Act [this section], the Secretary of Health and
Human Services shall—
‘‘(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
‘‘(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods
to estimate the thyroid doses of Iodine 131 that are
received by individuals from nuclear bomb fallout;
and
‘‘(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric
nuclear bomb tests.
‘‘(b)(1) Within one year after the date of enactment of
this Act [Jan. 4, 1983], the Secretary of Health and
Human Services shall devise and publish radioepidemiological tables that estimate the likelihood
that persons who have or have had any of the radiation
related cancers and who have received specific doses
prior to the onset of such disease developed cancer as
a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from
1 millirad to 1,000 rads in terms of sex, age at time of
exposure, time from exposure to the onset of the cancer
in question, and such other categories as the Secretary,
after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation
shall be calculated and displayed as a single percentage
figure.
‘‘(2) At the time the Secretary of Health and Human
Services publishes the tables pursuant to paragraph (1),
such Secretary shall also publish—
‘‘(A) for the tables of each radiation related cancer,
an evaluation which will assess the credibility, validity, and degree of certainty associated with such
tables; and
‘‘(B) a compilation of the formulas that yielded the
probabilities of causation listed in such tables. Such
formulas shall be published in such a manner and together with information necessary to determine the
probability of causation of any individual who has or
has had a radiation related cancer and has received
any given dose.
‘‘(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from
the best available data that are most applicable to the
United States, and shall be devised in accordance with
the best available scientific procedures and expertise.’’
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an

Page 122

advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
EXECUTIVE ORDER NO. 13435
Ex. Ord. No. 13435, June 20, 2007, 72 F.R. 34591, which
directed research with stem cells not derived from the
creation or destruction of a human embryo or fetus,
was revoked by Ex. Ord. No. 13505, § 5(b), Mar. 9, 2009, 74
F.R. 10668, set out below.
EX. ORD. NO. 13505. REMOVING BARRIERS TO RESPONSIBLE
SCIENTIFIC RESEARCH INVOLVING HUMAN STEM CELLS
Ex. Ord. No. 13505, Mar. 9, 2009, 74 F.R. 10667, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
SECTION 1. Policy. Research involving human embryonic stem cells and human non-embryonic stem cells
has the potential to lead to better understanding and
treatment of many disabling diseases and conditions.
Advances over the past decade in this promising scientific field have been encouraging, leading to broad
agreement in the scientific community that the research should be supported by Federal funds.
For the past 8 years, the authority of the Department
of Health and Human Services, including the National
Institutes of Health (NIH), to fund and conduct human
embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove
these limitations on scientific inquiry, to expand NIH
support for the exploration of human stem cell research, and in so doing to enhance the contribution of
America’s scientists to important new discoveries and
new therapies for the benefit of humankind.
SEC. 2. Research. The Secretary of Health and Human
Services (Secretary), through the Director of NIH, may
support and conduct responsible, scientifically worthy
human stem cell research, including human embryonic
stem cell research, to the extent permitted by law.
SEC. 3. Guidance. Within 120 days from the date of this
order, the Secretary, through the Director of NIH, shall
review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and
issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH,
shall review and update such guidance periodically, as
appropriate.
SEC. 4. General Provisions. (a) This order shall be implemented consistent with applicable law and subject
to the availability of appropriations.
(b) Nothing in this order shall be construed to impair
or otherwise affect:
(i) authority granted by law to an executive department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
SEC. 5. Revocations. (a) The Presidential statement of
August 9, 2001, limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.
(b) Executive Order 13435 of June 20, 2007, which supplements the August 9, 2001, statement on human embryonic stem cell research, is revoked.
BARACK OBAMA.
GUIDELINES FOR HUMAN STEM CELL RESEARCH
Memorandum of President of the United States, July
30, 2009, 74 F.R. 38885, provided:
Memorandum for the Heads of Executive Departments and Agencies

Page 123

TITLE 42—THE PUBLIC HEALTH AND WELFARE

As outlined in Executive Order 13505 of March 9, 2009,
my Administration is committed to supporting and
conducting ethically responsible, scientifically worthy
human stem cell research, including human embryonic
stem cell research, to the extent permitted by law. Pursuant to that order, the National Institutes of Health
(NIH) published final ‘‘National Institutes of Health
Guidelines for Human Stem Cell Research’’ (Guidelines), effective July 7, 2009. These Guidelines apply to
the expenditure of NIH funds for research using human
embryonic stem cells and certain uses of human induced pluripotent stem cells. The Guidelines are based
on the principles that responsible research with human
embryonic stem cells has the potential to improve our
understanding of human biology and aid in the discovery of new ways to prevent and treat illness, and that
individuals donating embryos for research purposes
should do so freely, with voluntary and informed consent. These Guidelines will ensure that NIH-funded research adheres to the highest ethical standards.
In order to ensure that all federally funded human
stem cell research is conducted according to these
same principles and to promote a uniform Federal policy across the executive branch, I hereby direct the
heads of executive departments and agencies that support and conduct stem cell research to adopt these
Guidelines, to the fullest extent practicable in light of
legal authorities and obligations. I also direct those departments and agencies to submit to the Director of
the Office of Management and Budget (OMB), within 90
days, proposed additions or revisions to any other guidance, policies, or procedures related to human stem cell
research, consistent with Executive Order 13505 and
this memorandum. The Director of the OMB shall, in
coordination with the Director of NIH, review these
proposals to ensure consistent implementation of Executive Order 13505 and this memorandum.
This memorandum is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other
person. Executive departments and agencies shall carry
out the provisions of this memorandum to the extent
permitted by law and consistent with their statutory
and regulatory authorities and their enforcement
mechanisms.
The Director of the OMB is hereby authorized and directed to publish this memorandum in the Federal Register.
BARACK OBAMA.

§ 242. Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation
with States
(a) In carrying out the purposes of section 241
of this title with respect to drugs the use or misuse of which might result in drug abuse or dependency, the studies and investigations authorized therein shall include the use and misuse of
narcotic drugs and other drugs. Such studies and
investigations shall further include the quantities of crude opium, coca leaves, and their
salts, derivatives, and preparations, and other
drugs subject to control under the Controlled
Substances Act [21 U.S.C. 801 et seq.] and Controlled Substances Import and Export Act [21
U.S.C. 951 et seq.], together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific requirements of
the United States. The results of studies and investigations of the quantities of narcotic drugs
or other drugs subject to control under such
Acts, together with reserves of such drugs, that
are necessary to supply the normal and emer-

§ 242

gency medicinal and scientific requirements of
the United States, shall be reported not later
than the first day of April of each year to the
Attorney General, to be used at his discretion in
determining manufacturing quotas or importation requirements under such Acts.
(b) The Surgeon General shall cooperate with
States for the purpose of aiding them to solve
their narcotic drug problems and shall give authorized representatives of the States the benefit of his experience in the care, treatment, and
rehabilitation of narcotic addicts to the end
that each State may be encouraged to provide
adequate facilities and methods for the care and
treatment of its narcotic addicts.
(July 1, 1944, ch. 373, title III, § 302, 58 Stat. 692;
Pub. L. 91–513, title II, § 701(j), Oct. 27, 1970, 84
Stat. 1282.)
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec.
(a), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat.
1242, as amended, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of Title 21, Food
and Drugs. For complete classification of this Act to
the Code, see Short Title note set out under section 801
of Title 21 and Tables.
The Controlled Substances Import and Export Act,
referred to in subsec. (a), is title III of Pub. L. 91–513,
Oct. 27, 1970, 84 Stat. 1285, as amended, which is classified principally to subchapter II (§ 951 et seq.) of chapter 13 of Title 21. For complete classification of this
Act to the Code, see Short Title note set out under section 951 of Title 21 and Tables.
AMENDMENTS
1970—Subsec. (a). Pub. L. 91–513 inserted references to
drug dependency, drugs other than narcotic drugs, and
substances subject to control under the Controlled Substances Act and the Controlled Substances Import and
Export Act, substituted the first day of April of each
year for the first day of September of each year as the
date by which the study results must be submitted,
substituted the Attorney General for the Secretary of
the Treasury as the officer to whom the report is to be
submitted, and struck out references to the Narcotic
Drugs Import and Export Act.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91–513 effective on first day of
seventh calendar month that begins after Oct. 26, 1970,
see section 704 of Pub. L. 91–513, set out as an Effective
Date note under section 801 of Title 21, Food and Drugs.
SAVINGS PROVISION
Amendment by Pub. L. 91–513 not to affect or abate
any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment,
and all administrative proceedings pending before the
Bureau of Narcotics and Dangerous Drugs on Oct. 27,
1970, to be continued and brought to final determination in accord with laws and regulations in effect prior
to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out
as a note under section 321 of Title 21, Food and Drugs.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 242a

TITLE 42—THE PUBLIC HEALTH AND WELFARE
MARIHUANA AND HEALTH REPORTING

Pub. L. 91–296, title V, June 30, 1970, 84 Stat. 352, as
amended by Pub. L. 95–461, § 3(a), Oct. 14, 1978, 92 Stat.
1268; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat.
695, known as the Marihuana and Health Reporting Act,
which required the Secretary of Health and Human
Services, after consultation with the Surgeon General
and other appropriate individuals, to transmit a report
to the Congress on or before January 31, 1971, and biennially thereafter (1) containing current information on
the health consequences of using marihuana, and (2)
containing such recommendations for legislative and
administrative action as he may deem appropriate, was
repealed by Pub. L. 98–24, § 2(d), Apr. 26, 1983, 97 Stat.
182.

§ 242a. Repealed. Pub. L. 106–310, div. B, title
XXXII, § 3201(b)(1), Oct. 17, 2000, 114 Stat.
1190
Section, act July 1, 1944, ch. 373, title III, § 303, as
added July 3, 1946, ch. 538, § 7(c), 60 Stat. 423; amended
Aug. 2, 1956, ch. 871, title V, § 501, 70 Stat. 929; Pub. L.
91–513, title I, § 3(a), Oct. 27, 1970, 84 Stat. 1241; Pub. L.
93–282, title I, § 122(b), May 14, 1974, 88 Stat. 132; Pub. L.
93–348, title I, § 104(a)(2), July 12, 1974, 88 Stat. 346; Pub.
L. 95–633, title I, § 108(b), Nov. 10, 1978, 92 Stat. 3773; Pub.
L. 96–398, title VIII, § 803(a), Oct. 7, 1980, 94 Stat. 1607;
Pub. L. 100–177, title II, § 202(a), Dec. 1, 1987, 101 Stat.
996; Pub. L. 100–607, title I, § 163(1)(A), Nov. 4, 1988, 102
Stat. 3062; Pub. L. 100–690, title II, § 2058(b), Nov. 18,
1988, 102 Stat. 4214; Pub. L. 101–597, title IV, § 401(b)[(a)],
Nov. 16, 1990, 104 Stat. 3035; Pub. L. 102–321, title I,
§ 115(b), July 10, 1992, 106 Stat. 348; Pub. L. 102–408, title
III, § 305, Oct. 13, 1992, 106 Stat. 2084; Pub. L. 105–392,
title IV, § 403, Nov. 13, 1998, 112 Stat. 3588, related to
mental health.

§ 242b. General authority respecting research,
evaluations, and demonstrations in health
statistics, health services, and health care
technology
(a) Scope of activities
The Secretary may, through the Agency for
Healthcare Research and Quality or the National Center for Health Statistics, or using
Ruth L. Kirschstein National Research Service
Awards or other appropriate authorities, undertake and support training programs to provide
for an expanded and continuing supply of individuals qualified to perform the research, evaluation, and demonstration projects set forth in
section 242k of this title and in subchapter VII
of this chapter.
(b) Additional authority; scope of activities
To implement subsection (a) of this section
and section 242k of this title, the Secretary
may, in addition to any other authority which
under other provisions of this chapter or any
other law may be used by him to implement
such subsection, do the following:
(1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the
physical resources of such Department, provide technical assistance and advice, make
grants to public and nonprofit private entities
and individuals, and, when appropriate, enter
into contracts with public and private entities
and individuals.
(2) Admit and treat at hospitals and other
facilities of the Service persons not otherwise

Page 124

eligible for admission and treatment at such
facilities.
(3) Secure, from time to time and for such
periods as the Secretary deems advisable but
in accordance with section 3109 of title 5, the
assistance and advice of consultants from the
United States or abroad. The Secretary may
for the purpose of carrying out the functions
set forth in sections 242c,1 242k, and 242n 1 of
this title, obtain (in accordance with section
3109 of title 5, but without regard to the limitation in such section on the number of days
or the period of service) for each of the centers
the services of not more than fifteen experts
who have appropriate scientific or professional
qualifications.
(4) Acquire, construct, improve, repair, operate, and maintain laboratory, research, and
other necessary facilities and equipment, and
such other real or personal property (including
patents) as the Secretary deems necessary;
and acquire, without regard to section 8141 of
title 40, by lease or otherwise, through the Administrator of General Services, buildings or
parts of buildings in the District of Columbia
or communities located adjacent to the District of Columbia.
(c) Coordination of activities through units of
Department
(1) The Secretary shall coordinate all health
services research, evaluations, and demonstrations, all health statistical and epidemiological
activities, and all research, evaluations, and
demonstrations respecting the assessment of
health care technology undertaken and supported through units of the Department of
Health and Human Services. To the maximum
extent feasible such coordination shall be carried out through the Agency for Healthcare Research and Quality and the National Center for
Health Statistics.
(2) The Secretary shall coordinate the health
services research, evaluations, and demonstrations, the health statistical and (where appropriate) epidemiological activities, and the research, evaluations, and demonstrations respecting the assessment of health care technology authorized by this chapter through the
Agency for Healthcare Research and Quality and
the National Center for Health Statistics.
(July 1, 1944, ch. 373, title III, § 304, as added July
28, 1955, ch. 417, § 3, 69 Stat. 382; amended Aug. 2,
1956, ch. 871, title V, § 502, 70 Stat. 930; Pub. L.
90–174, § 3(a), Dec. 5, 1967, 81 Stat. 534; Pub. L.
91–296, title IV, § 401(b)(1)(A), June 30, 1970, 84
Stat. 352; Pub. L. 91–515, title II, §§ 201(a)–(c), 202,
203, Oct. 30, 1970, 84 Stat. 1301–1303; Pub. L. 93–45,
title I, § 102, June 18, 1973, 87 Stat. 91; Pub. L.
93–353, title I, § 103, July 23, 1974, 88 Stat. 362;
Pub. L. 95–623, §§ 3, 7, Nov. 9, 1978, 92 Stat. 3443,
3451; Pub. L. 96–32, § 5(a)–(c), July 10, 1979, 93
Stat. 82; Pub. L. 97–35, title IX, § 918, Aug. 13,
1981, 95 Stat. 565; Pub. L. 98–551, § 5(c), Oct. 30,
1984, 98 Stat. 2819; Pub. L. 101–239, title VI,
§ 6103(e)(1), Dec. 19, 1989, 103 Stat. 2205; Pub. L.
103–183, title V, § 501(b), Dec. 14, 1993, 107 Stat.
2237; Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999, 113
Stat. 1670; Pub. L. 107–206, title I, § 804(c), Aug. 2,
2002, 116 Stat. 874.)
1 See

References in Text note below.

Page 125

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

Sections 242c and 242n of this title, referred to in subsec. (b)(3), were repealed by Pub. L. 101–239, title VI,
§ 6103(d)(1), Dec. 19, 1989, 103 Stat. 2205.
CODIFICATION
In subsec. (b)(4), ‘‘section 8141 of title 40’’ substituted
for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303,
the first section of which enacted Title 40, Public
Buildings, Property, and Works.
AMENDMENTS
2002—Subsec. (a). Pub. L. 107–206 substituted ‘‘Ruth L.
Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’.
1999—Subsecs. (a), (c). Pub. L. 106–129 substituted
‘‘Agency for Healthcare Research and Quality’’ for
‘‘Agency for Health Care Policy and Research’’ wherever appearing.
1993—Subsec. (d). Pub. L. 103–183 struck out subsec.
(d) which directed Secretary to conduct an ongoing
study of present and projected future health costs of
pollution and other environmental conditions resulting
from human activity and to submit to Congress reports
on the study.
1989—Subsec. (a). Pub. L. 101–239, § 6103(e)(1)(B), substituted ‘‘the Agency for Health Care Policy and Research’’ for ‘‘the National Center for Health Services
Research and Health Care Technology Assessment’’ and
‘‘in section 242k of this title and in subchapter VII of
this chapter’’ for ‘‘in sections 242c, 242k, and 242n of
this title’’.
Pub. L. 101–239, § 6103(e)(1)(A), redesignated par. (3) as
entire subsec. (a) and struck out pars. (1) and (2) which
required Secretary to conduct and support research,
demonstrations, evaluations, and statistical and epidemiological activities for purpose of improving health
services in the United States, and which specified types
of activities Secretary was to emphasize in carrying
out par. (1).
Subsec. (b). Pub. L. 101–239, § 6103(e)(1)(C), substituted
‘‘subsection (a) of this section and section 242k of this
title’’ for ‘‘subsection (a) of this section’’.
Subsec. (c)(1), (2). Pub. L. 101–239, § 6103(e)(1)(D), substituted ‘‘the Agency for Health Care Policy and Research’’ for ‘‘the National Center for Health Services
Research and Health Care Technology Assessment’’.
1984—Subsec. (a)(1). Pub. L. 98–551, § 5(c)(1), (2), substituted ‘‘the National Center for Health Services Research and Health Care Technology Assessment and the
National Center for Health Statistics’’ for ‘‘the National Center for Health Services Research, the National Center for Health Statistics, and the National
Center for Health Care Technology’’.
Subsec. (a)(3). Pub. L. 98–551, § 5(c)(1), (3), substituted
‘‘the National Center for Health Services Research and
Health Care Technology Assessment or the National
Center for Health Statistics’’ for ‘‘the National Center
for Health Services Research, the National Center for
Health Statistics, or the National Center for Health
Care Technology’’.
Subsec. (c)(1), (2). Pub. L. 98–551, § 5(c)(1), (2), substituted ‘‘the National Center for Health Services Research and Health Care Technology Assessment and the
National Center for Health Statistics’’ for ‘‘the National Center for Health Services Research, the National Center for Health Statistics, and the National
Center for Health Care Technology’’.
1981—Subsec. (a)(3). Pub. L. 97–35, § 918(a), substituted
‘‘may’’ for ‘‘shall’’, ‘‘or the’’ for ‘‘and the’’, ‘‘or using’’
for ‘‘and using’’, and ‘‘or other’’ for ‘‘and other’’.
Subsecs. (b)(1), (c)(1). Pub. L. 97–35, § 918(d)(1), substituted ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’.
Subsec. (d)(1). Pub. L. 97–35, § 918(b)(1), (2), substituted
provisions relating to advice and assistance of the National Academy of Sciences, for provisions relating to
joint authority of the National Academy of Sciences,

§ 242b

and struck out definition of ‘‘Academy’’ as meaning the
National Academy of Sciences.
Subsec. (d)(3). Pub. L. 97–35, § 918(b)(3), (c), (d)(2), substituted ‘‘every three years’’ for ‘‘every two years’’, and
‘‘Energy and’’ for ‘‘Interstate and Foreign’’, and struck
out references to the Academy.
1979—Subsec. (b)(1), (3). Pub. L. 96–32, § 5(a), (b),
amended directory language of Pub. L. 95–623, § 3(b), (d),
and required no change in text. See 1978 Amendment
note below.
Subsec. (d). Pub. L. 96–32, § 5(c), substituted ‘‘(d)’’ for
‘‘(e)’’ as designation of subsection added by Pub. L.
95–623, § 7, thereby correcting the subsection designation.
1978—Subsec. (a)(1). Pub. L. 95–623, § 3(a), substituted
provision for the Secretary acting through the National Center for Health Care Technology for such action through other units of the Department of Health,
Education, and Welfare and ‘‘conduct’’ for ‘‘undertake’’, included epidemiological activities, and declared as an objective the improvement of the effectiveness, efficiency, and quality of Federal health services.
Subsec. (a)(2). Pub. L. 95–623, § 3(a), provided for emphasis to demonstrations, evaluations, and epidemiological activities; redesignated as subpar. (A) former
subpar. (C); struck out ‘‘technology’’ and ‘‘quality’’
after ‘‘organization,’’ and ‘‘utilization,’’, respectively,
and end clause ‘‘including systems for the delivery of
preventive, personal, and mental health care’’ and
former subpar. (A) activities respecting ‘‘the determination of an individual’s health’’; added subpars. (B)
through (D); struck out former subpar. (D) activities
respecting ‘‘individual and community knowledge of individual health and the systems for the delivery of
health care’’; added subpars. (E) through (I); and redesignated as subpar. (J) former subpar. (B).
Subsec. (a)(3). Pub. L. 95–623, § 3(a), added par. (3).
Subsec. (b)(1). Pub. L. 95–623, § 3(b), as amended by
Pub. L. 96–32, § 5(a), substituted ‘‘, when appropriate,
enter into contracts with public and private entities
and individuals’’ for ‘‘enter into contracts with public
and private entities and individuals, for (A) health
services research, evaluation, and demonstrations, and
(B) health services research and health statistics training, and (C) health statistical activities’’.
Subsec. (b)(3). Pub. L. 95–623, § 3(d), as amended by
Pub. L. 96–32, § 5(b), substituted ‘‘advisable but in accordance with section 3109 of title 5’’ for ‘‘advisable’’,
struck out ‘‘experts and’’ before ‘‘consultants’’, and authorized the Secretary to obtain for the centers the
services of experts with appropriate scientific or professional qualifications.
Subsec. (c). Pub. L. 95–623, § 3(c), designated existing
text as par. (1), substituted ‘‘evaluations, and demonstrations, all health statistical and epidemiological
activities, and all research, evaluations, and demonstrations respecting the assessment of health care
technology’’ for ‘‘evaluation, demonstration, and
health statistical activities’’ before ‘‘undertaken and
supported’’, required coordination of activities to also
be carried out through the National Center for Health
Care Technology, and added par. (2).
Subsec. (d). Pub. L. 95–623, § 7, as amended by Pub. L.
96–32, § 5(c), added subsec. (d).
1974—Pub. L. 93–353, in revising generally provisions
of subsecs. (a) to (c), provided for general authority respecting health statistics and health services research,
evaluation, and demonstrations, subsec. (a) relating to
scope of activities, subsec. (b) relating to additional authority and scope of activities, and subsec. (c) relating
to coordination of activities through units of the Department. Former provisions related to research and
demonstrations relating to health facilities and services, subsec. (a) relating to grants and contracts for
projects for research, experiments, or demonstrations
and related training, cost limitation, wage rates, labor
standards, and other conditions, and payments (former
subsec. (a)(2) and (3) now being covered by section
242m(h) and (e), respectively), subsec. (b) relating to
systems analysis of national health care plans, and cost

§ 242b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and coverage report on existing legislative proposals,
and subsec. (c) relating to authorization of appropriations.
1973—Subsec. (c)(1). Pub. L. 93–45 authorized appropriations of $42,617,000 for fiscal year ending June 30,
1974.
1970—Subsec. (a)(1). Pub. L. 91–515, §§ 201(a)(1), 203, redesignated subsec. (a) as (a)(1), substituted ‘‘(A)’’ and
‘‘(B)’’ for ‘‘(1)’’ and ‘‘(2)’’, and ‘‘(i) to (iii)’’ for ‘‘(A) to
(C)’’, and added cls. (iv) and (v).
Subsec. (a)(2). Pub. L. 91–515, § 201(a)(2), redesignated
subsec. (b) as (a)(2), and substituted ‘‘subsection’’ for
‘‘section’’ wherever appearing.
Subsec. (a)(3). Pub. L. 91–515, §§ 201(a)(3), 202, redesignated subsec. (c) as (a)(3)(A), substituted ‘‘subsection’’
for ‘‘section’’ wherever appearing, and added subsec.
(a)(3)(B).
Subsec. (b). Pub. L. 91–515, § 201(a)(2)(A), (b), added
subsec. (b). Former subsec. (b) redesignated (a)(2).
Subsecs. (c), (d). Pub. L. 91–515, §§ 201(a)(3)(A), (c),
202(1), redesignated subsec. (d) as (c), and substituted
provisions authorizing appropriations for the fiscal
years ending June 30, 1971, June 30, 1972, and June 30,
1973, and authorizing to be appropriated such additional
sums for each fiscal year as may be necessary to carry
out the provisions of subsec. (b), for provisions authorizing appropriations of $20,000,000 for the fiscal year
ending June 30, 1968, $40,000,000 for the fiscal year ending June 30, 1969, and $60,000,000 for the fiscal year ending June 30, 1970. Former subsec. (c) redesignated
(a)(3)(A).
Pub. L. 91–296 struck out provisions authorizing use
of appropriated funds for evaluation of program authorized by this section. See section 229b of this title.
1967—Pub. L. 90–174 substituted provisions of subsecs.
(a) to (d) for research and demonstrations relating to
health facilities (incorporated from former section 291n
of this title) for provisions of former subsecs. (a) to (d)
for mental health study including grants for special
projects, conditions thereof, and definition of ‘‘organization’’, authorization of appropriations, terms of
grant, availability of amounts otherwise appropriated
and noninterference with research and study programs
of the National Institute of Mental Health, and acceptance of additional financial support.
1956—Act Aug. 2, 1956, changed heading of section 304
of act July 1, 1944 from ‘‘Grants for special projects in
mental health’’ to ‘‘Mental health study grants’’. Section heading has been changed for purposes of codification.
EFFECTIVE DATE OF 1970 AMENDMENTS
Section 201(d) of Pub. L. 91–515 provided that: ‘‘The
amendments made by subsection (c) of this section
[amending this section] shall be effective only with respect to fiscal years ending after June 30, 1970.’’
Section 401(b)(1) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to appropriations for fiscal years beginning after
June 30, 1970.
EFFECTIVE DATE OF 1956 AMENDMENT
Amendment of section by act Aug. 2, 1956, effective
July 1, 1956, see section 503 of act Aug. 2, 1956.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
COMMISSION ON SYSTEMIC INTEROPERABILITY
Pub. L. 108–173, title X, § 1012, Dec. 8, 2003, 117 Stat.
2435, directed the Secretary of Health and Human Serv-

Page 126

ices to establish a commission to be known as the
‘‘Commission on Systemic Interoperability’’, which
would develop a comprehensive strategy for the adoption and implementation of health care information
technology standards, and which would terminate 30
days after submitting a report, not later than Oct. 31,
2005, to the Secretary and to Congress, describing the
strategy developed.
MODEL STANDARDS WITH RESPECT TO PREVENTIVE
HEALTH SERVICES IN COMMUNITIES
Pub. L. 95–83, title III, § 314, Aug. 1, 1977, 91 Stat. 398,
required the Secretary of Health, Education, and Welfare, within two years of Aug. 1, 1977, to establish
model standards with respect to preventive health services in communities and report such standards to Congress.
TRANSFER OF EQUIPMENT
Pub. L. 94–573, § 15, Oct. 21, 1976, 90 Stat. 2719, provided
that notwithstanding any other provision of law, the
Secretary of Health, Education, and Welfare could vest
title to equipment purchased with funds under the
seven contracts for emergency medical services demonstration projects entered into in 1972 and 1973 under
this section (as in effect at the time the contracts were
entered into), and by contractors with the United
States under such contracts or subcontractors under
such contracts, in such contractors or subcontractors
without further obligation to the Government or on
such terms as the Secretary considered appropriate.
CONGRESSIONAL DECLARATION OF PURPOSE
Section 2 of Joint Res. July 28, 1955, provides a Congressional statement of the critical need for an analysis and reevaluation of the human and economic problems of mental illness and of the resources, methods,
and practices utilized in diagnosing, treating, caring
for, and rehabilitating the mentally ill, both within
and outside of institutions, as might lead to the development of recommendations for such better utilization
of those resources or such improvements on and new
developments in methods of diagnosis, treatment, care,
and rehabilitation as give promise of resulting in a
marked reduction in the incidence or duration of mental illness and, in consequence, a lessening of the appalling emotional and financial drain on the families of
those afflicted or on the economic resources of the
States and of the Nation and a declaration of the policy
to promote mental health and to help solve the complex and the interrelated problems posed by mental illness by encouraging the undertaking of nongovernmental, multidisciplinary research into and reevaluation of all aspects of our resources, methods, and practices for diagnosing, treating, caring for, and rehabilitating the mentally ill, including research aimed at the
prevention of mental illness.
CHILDREN’S EMOTIONAL ILLNESS STUDY; PROGRAM
GRANTS; CONDITIONS; DEFINITIONS; APPROPRIATIONS;
TERMS OF GRANT
Pub. L. 89–97, title II, § 231, July 30, 1965, 79 Stat. 360,
as amended by Pub. L. 90–248, title III, § 305, Jan. 2, 1968,
81 Stat. 929, authorized the Secretary of Health, Education, and Welfare upon the recommendation of the
National Advisory Mental Health Council and after securing the advice of experts in pediatrics and child welfare, to make grants to organizations on certain conditions for carrying out a program of research into and
study of resources, methods, and practices for diagnosing or preventing emotional illness in children and of
treating, caring for, and rehabilitating children with
emotional illnesses, defined ‘‘organization’’, and authorized appropriations for the making of such grants
for fiscal years ending June 30, 1966, and June 30, 1967,
with such research and study to be completed not later
than three years from the date it was inaugurated.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 242k

§ 242c. Repealed. Pub. L. 101–239, title VI,
§ 6103(d)(1)(A), Dec. 19, 1989, 103 Stat. 2205

§§ 242f to 242j. Transferred

Section, act July 1, 1944, ch. 373, title III, § 305, as
added July 3, 1956, ch. 510, § 3, 70 Stat. 490; amended Oct.
30, 1970, Pub. L. 91–515, title II, § 210, 84 Stat. 1303; June
18, 1973, Pub. L. 93–45, title I, § 103, 87 Stat. 91; July 23,
1974, Pub. L. 93–353, title I, § 104, 88 Stat. 363; Oct. 8, 1976,
Pub. L. 94–460, title III, § 301, 90 Stat. 1960; Nov. 9, 1978,
Pub. L. 95–623, § 4, 92 Stat. 3445; Aug. 13, 1981, Pub. L.
97–35, title IX, § 919(a)(1), (2)(A), (3), (b)(1), (c), (d), 95
Stat. 565, 566; Oct. 30, 1984, Pub. L. 98–551, §§ 5(a), (b), 6,
98 Stat. 2817, 2819, 2820; Oct. 7, 1985, Pub. L. 99–117, § 6,
99 Stat. 492; Nov. 14, 1986, Pub. L. 99–660, title III,
§ 311(b)(2), 100 Stat. 3779; Dec. 1, 1987, Pub. L. 100–177,
title I, §§ 101, 102, 101 Stat. 987; Nov. 4, 1988, Pub. L.
100–607, title II, § 204(1), 102 Stat. 3079; Nov. 18, 1988, Pub.
L. 100–690, title II, § 2620(b)(3), 102 Stat. 4244; Aug. 16,
1989, Pub. L. 101–93, § 5(e)(3), 103 Stat. 612, related to National Center for Health Services Research and Health
Care Technology Assessment.

Section 242f, act July 1, 1944, ch. 373, title III, § 308, as
added July 12, 1960, Pub. L. 86–610, § 3, 74 Stat. 364,
which related to international cooperation with respect
to biomedical research and health services research and
statistical activities, was renumbered section 307 of act
July 1, 1944, by Pub. L. 93–353 and transferred to section
242l of this title.
Section 242g, act July 1, 1944, ch. 373, title III, § 309, as
added Sept. 8, 1960, Pub. L. 86–720, § 1(a), 74 Stat. 819;
amended Aug. 27, 1964, Pub. L. 88–497, § 3, 78 Stat. 613;
Nov. 3, 1966, Pub. L. 89–749, § 4, 80 Stat. 1190; Dec. 5, 1967,
Pub. L. 90–147, §§ 2(g), 8(c), 81 Stat. 534, 540; Aug. 16, 1968,
Pub. L. 90–490, title III, § 302(a), 82 Stat. 788; Mar. 12,
1970, Pub. L. 91–208, §§ 1, 2, 84 Stat. 52; June 30, 1970, Pub.
L. 91–296, title IV, § 401(b)(1)(B), 84 Stat. 352; June 18,
1973, Pub. L. 93–45, title I, § 104(b), (c), 87 Stat. 91, which
related to graduate public health training grants, was
renumbered section 313 of act July 1, 1944, by Pub. L.
93–353 and transferred to section 245a of this title, and
was subsequently repealed.
Section 242h, act July 1, 1944, ch. 373, title III, § 310,
as added Sept. 25, 1962, Pub. L. 87–692, 76 Stat. 592, and
amended and renumbered, which related to health services for domestic agricultural migrants, was renumbered section 319 of act July 1, 1944, by Pub. L. 93–353,
title I, § 102(d), July 23, 1974, 88 Stat. 362, transferred to
section 247d of this title, and subsequently renumbered
and transferred to section 254b of this title, prior to
being omitted in the general amendment of subpart I
(§ 254b et seq.) of part D of this subchapter by Pub. L.
104–299, § 2.
Section 242i, act July 1, 1944, ch. 373, title III, § 310A,
as added Oct. 30, 1970, Pub. L. 91–515, title II, § 270, 84
Stat. 1306; amended Nov. 18, 1971, Pub. L. 92–157, title II,
§ 201, 85 Stat. 461, which related to administration of
grants in multigrant projects, was renumbered section
226 of act July 1, 1944, by Pub. L. 93–353 and transferred
to section 235 of this title.
Section 242j, act July 1, 1944, ch. 373, title III, § 310B,
as added Oct. 30, 1970, Pub. L. 91–515, title II, § 280, 84
Stat. 1307, which provided for and annual report by Secretary on activities related to health facilities and
services and expenditure of funds, was renumbered section 227 of act July 1, 1944, by Pub. L. 93–353 and transferred to section 236 of this title, and was subsequently
repealed.

TERMINATION OF NATIONAL CENTER FOR HEALTH SERVICES RESEARCH AND HEALTH CARE TECHNOLOGY ASSESSMENT

Section 6103(d)(1)(A) of Pub. L. 101–239 provided in
part that the National Center for Health Services Research and Health Care Technology Assessment is terminated.
TRANSITIONAL AND SAVINGS PROVISIONS FOR
PUB. L. 101–239
For provision transferring personnel of Department
of Health and Human Services employed on Dec. 19,
1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to
amendments made by section 6103 of Pub. L. 101–239,
and assets, liabilities, etc., of Department arising from
or employed, held, used, or available on that date, or to
be made available after that date, in connection with
those functions, to Administrator for appropriate allocation, and for provisions for continued effectiveness of
actions, orders, rules, official documents, etc., of Department that have been issued, made, granted, or allowed to become effective in performance of those functions, and that were effective on Dec. 19, 1989, see section 6103(f) of Pub. L. 101–239, set out as a note under
section 299 of this title.

§ 242d. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title III, § 306, as
added Aug. 2, 1956, ch. 871, title I, § 101, 70 Stat. 923;
amended July 23, 1959, Pub. L. 86–105, § 1, 73 Stat. 239;
Sept. 8, 1960, Pub. L. 88–497, § 2, 78 Stat. 613; Aug. 16,
1968, Pub. L. 90–490, title III, § 302(b), 82 Stat. 789; Mar.
12, 1970, Pub. L. 91–208, § 3, 84 Stat. 52; Oct. 30, 1970, Pub.
L. 91–515, title VI, § 601(b)(2), 84 Stat. 1311; June 18, 1973,
Pub. L. 93–45, title I, § 104(a), 87 Stat. 91, which related
to graduate or specialized training for physicians, engineers, nurses, and other professional personnel, was renumbered section 312 of act July 1, 1944, by Pub. L.
93–353 and transferred to section 244–1 of this title, and
was subsequently repealed.

§ 242e. Repealed. Pub. L. 93–353, title I, § 102(a),
July 23, 1974, 88 Stat. 362
Section, act July 1, 1944, ch. 373, title III, § 307, as
added Aug. 2, 1956, ch. 871, title II, § 201, 70 Stat. 924;
amended July 23, 1959, Pub. L. 86–105, § 2, 73 Stat. 239;
Oct. 30, 1970, Pub. L. 91–515, title VI, § 601(b)(2), 84 Stat.
1311, provided for a professional nurse traineeship program for which authorization of appropriations were
made through fiscal year ending June 30, 1964. Provision for the continuation of the program was made by
the Nurse Training Act of 1964, which enacted section
297 et seq. of this title.

CODIFICATION

§ 242k. National Center for Health Statistics
(a) Establishment; appointment of Director; statistical and epidemiological activities
There is established in the Department of
Health and Human Services the National Center
for Health Statistics (hereinafter in this section
referred to as the ‘‘Center’’) which shall be
under the direction of a Director who shall be
appointed by the Secretary. The Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities
for the purpose of improving the effectiveness,
efficiency, and quality of health services in the
United States.
(b) Duties
In carrying out subsection (a) of this section,
the Secretary, acting through the Center,
(1) shall collect statistics on—
(A) the extent and nature of illness and
disability of the population of the United
States (or of any groupings of the people included in the population), including life expectancy, the incidence of various acute and
chronic illnesses, and infant and maternal
morbidity and mortality,

§ 242k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the impact of illness and disability of
the population on the economy of the United
States and on other aspects of the well-being
of its population (or of such groupings),
(C) environmental, social, and other health
hazards,
(D) determinants of health,
(E) health resources, including physicians,
dentists, nurses, and other health professionals by specialty and type of practice and
the supply of services by hospitals, extended
care facilities, home health agencies, and
other health institutions,
(F) utilization of health care, including
utilization of (i) ambulatory health services
by specialties and types of practice of the
health professionals providing such services,
and (ii) services of hospitals, extended care
facilities, home health agencies, and other
institutions,
(G) health care costs and financing, including the trends in health care prices and cost,
the sources of payments for health care services, and Federal, State, and local governmental expenditures for health care services,
and
(H) family formation, growth, and dissolution;
(2) shall undertake and support (by grant or
contract) research, demonstrations, and evaluations respecting new or improved methods
for obtaining current data on the matters referred to in paragraph (1);
(3) may undertake and support (by grant or
contract) epidemiological research, demonstrations, and evaluations on the matters
referred to in paragraph (1); and
(4) may collect, furnish, tabulate, and analyze statistics, and prepare studies, on matters
referred to in paragraph (1) upon request of
public and nonprofit private entities under arrangements under which the entities will pay
the cost of the service provided.
Amounts appropriated to the Secretary from
payments made under arrangements made under
paragraph (4) shall be available to the Secretary
for obligation until expended.
(c) Statistical and epidemiological compilations
and surveys
The Center shall furnish such special statistical and epidemiological compilations and surveys as the Committee on Labor and Human Resources and the Committee on Appropriations of
the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of Representatives may request. Such statistical and epidemiological compilations and surveys shall not be made subject
to the payment of the actual or estimated cost
of the preparation of such compilations and surveys.
(d) Technical aid to States and localities
To insure comparability and reliability of
health statistics, the Secretary shall, through
the Center, provide adequate technical assistance to assist State and local jurisdictions in
the development of model laws dealing with issues of confidentiality and comparability of
data.

Page 128

(e) Cooperative Health Statistics System
For the purpose of producing comparable and
uniform health information and statistics, there
is established the Cooperative Health Statistics
System. The Secretary, acting through the Center, shall—
(1) coordinate the activities of Federal agencies involved in the design and implementation of the System;
(2) undertake and support (by grant or contract) research, development, demonstrations,
and evaluations respecting the System;
(3) make grants to and enter into contracts
with State and local health agencies to assist
them in meeting the costs of data collection
and other activities carried out under the System; and
(4) review the statistical activities of the Department of Health and Human Services to assure that they are consistent with the System.
States participating in the System shall designate a State agency to administer or be responsible for the administration of the statistical activities within the State under the System. The Secretary, acting through the Center,
shall prescribe guidelines to assure that statistical activities within States participating in
the system 1 produce uniform and timely data
and assure appropriate access to such data.
(f) Federal-State cooperation
To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate and consult with the Departments of Commerce and Labor and any other interested Federal departments or agencies and with State and
local health departments and agencies. For such
purpose he shall utilize insofar as possible the
services or facilities of any agency of the Federal Government and, without regard to section
6101 of title 41, of any appropriate State or other
public agency, and may, without regard to such
section, utilize the services or facilities of any
private agency, organization, group, or individual, in accordance with written agreements between the head of such agency, organization, or
group and the Secretary or between such individual and the Secretary. Payment, if any, for
such services or facilities shall be made in such
amounts as may be provided in such agreement.
(g) Collection of health data; data collection
forms
To secure uniformity in the registration and
collection of mortality, morbidity, and other
health data, the Secretary shall prepare and distribute suitable and necessary forms for the collection and compilation of such data.
(h) Registration area records
(1) There shall be an annual collection of data
from the records of births, deaths, marriages,
and divorces in registration areas. The data
shall be obtained only from and restricted to
such records of the States and municipalities
which the Secretary, in his discretion, determines possess records affording satisfactory
data in necessary detail and form. The Secretary shall encourage States and registration
1 So

in original. Probably should be capitalized.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

areas to obtain detailed data on ethnic and racial populations, including subpopulations of
Hispanics, Asian Americans, and Pacific Islanders with significant representation in the State
or registration area. Each State or registration
area shall be paid by the Secretary the Federal
share of its reasonable costs (as determined by
the Secretary) for collecting and transcribing
(at the request of the Secretary and by whatever
method authorized by him) its records for such
data.
(2) There shall be an annual collection of data
from a statistically valid sample concerning the
general health, illness, and disability status of
the civilian noninstitutionalized population.
Specific topics to be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations, and the relationship between demographic and socioeconomic characteristics
and health characteristics.
(i) Technical assistance in effective use of statistics
The Center may provide to public and nonprofit private entities technical assistance in
the effective use in such activities of statistics
collected or compiled by the Center.
(j) Coordination of health statistical and epidemiological activities
In carrying out the requirements of section
242b(c) of this title and paragraph (1) of subsection (e) of this section, the Secretary shall
coordinate health statistical and epidemiological activities of the Department of Health and
Human Services by—
(1) establishing standardized means for the
collection of health information and statistics
under laws administered by the Secretary;
(2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the minimum sets of
data needed on a continuing basis to fulfill the
collection requirements of subsection (b)(1) of
this section;
(3) after consultation with the National
Committee on Vital and Health Statistics, establishing standards to assure the quality of
health statistical and epidemiological data
collection, processing, and analysis;
(4) in the case of proposed health data collections of the Department which are required to
be reviewed by the Director of the Office of
Management and Budget under section 3509 2 of
title 44, reviewing such proposed collections to
determine whether they conform with the
minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3),
and if any such proposed collection is found
not to be in conformance, by taking such action as may be necessary to assure that it will
conform to such sets of data and standards,
and
(5) periodically reviewing ongoing health
data collections of the Department, subject to
review under such section 3509,2 to determine
if the collections are being conducted in ac2 See

References in Text note below.

§ 242k

cordance with the minimum sets of data and
the standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is
found not to be in conformance, by taking
such action as may be necessary to assure that
the collection will conform to such sets of
data and standards not later than the ninetieth day after the date of the completion of
the review of the collection.
(k) National Committee on Vital and Health Statistics; establishment; membership; term of
office; compensation; functions; consultations of Secretary with Committee and professional advisory groups
(1) There is established in the Office of the
Secretary a committee to be known as the National Committee on Vital and Health Statistics
(hereinafter in this subsection referred to as the
‘‘Committee’’) which shall consist of 18 members.
(2) The members of the Committee shall be appointed from among persons who have distinguished themselves in the fields of health statistics, electronic interchange of health care information, privacy and security of electronic information, population-based public health, purchasing or financing health care services, integrated computerized health information systems, health services research, consumer interests in health information, health data standards, epidemiology, and the provision of health
services. Members of the Committee shall be appointed for terms of 4 years.
(3) Of the members of the Committee—
(A) 1 shall be appointed, not later than 60
days after August 21, 1996, by the Speaker of
the House of Representatives after consultation with the Minority Leader of the House of
Representatives;
(B) 1 shall be appointed, not later than 60
days after August 21, 1996, by the President pro
tempore of the Senate after consultation with
the Minority Leader of the Senate; and
(C) 16 shall be appointed by the Secretary.
(4) Members of the Committee shall be compensated in accordance with section 210(c) of
this title.
(5) The Committee—
(A) shall assist and advise the Secretary—
(i) to delineate statistical problems bearing on health and health services which are
of national or international interest;
(ii) to stimulate studies of such problems
by other organizations and agencies whenever possible or to make investigations of
such problems through subcommittees;
(iii) to determine, approve, and revise the
terms, definitions, classifications, and guidelines for assessing health status and health
services, their distribution and costs, for use
(I) within the Department of Health and
Human Services, (II) by all programs administered or funded by the Secretary, including
the Federal-State-local cooperative health
statistics system referred to in subsection
(e) of this section, and (III) to the extent
possible as determined by the head of the
agency involved, by the Department of Veterans Affairs, the Department of Defense,
and other Federal agencies concerned with
health and health services;

§ 242k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iv) with respect to the design of and approval of health statistical and health information systems concerned with the collection, processing, and tabulation of health
statistics within the Department of Health
and Human Services, with respect to the Cooperative Health Statistics System established under subsection (e) of this section,
and with respect to the standardized means
for the collection of health information and
statistics to be established by the Secretary
under subsection (j)(1) of this section;
(v) to review and comment on findings and
proposals developed by other organizations
and agencies and to make recommendations
for their adoption or implementation by
local, State, national, or international agencies;
(vi) to cooperate with national committees
of other countries and with the World Health
Organization and other national agencies in
the studies of problems of mutual interest;
(vii) to issue an annual report on the state
of the Nation’s health, its health services,
their costs and distributions, and to make
proposals for improvement of the Nation’s
health statistics and health information systems; and
(viii) in complying with the requirements
imposed on the Secretary under part C of
title XI of the Social Security Act [42 U.S.C.
1320d et seq.];
(B) shall study the issues related to the
adoption of uniform data standards for patient
medical record information and the electronic
exchange of such information;
(C) shall report to the Secretary not later
than 4 years after August 21, 1996, recommendations and legislative proposals for such
standards and electronic exchange; and
(D) shall be responsible generally for advising the Secretary and the Congress on the
status of the implementation of part C of title
XI of the Social Security Act [42 U.S.C. 1320d
et seq.].
(6) In carrying out health statistical activities
under this part, the Secretary shall consult
with, and seek the advice of, the Committee and
other appropriate professional advisory groups.
(7) Not later than 1 year after August 21, 1996,
and annually thereafter, the Committee shall
submit to the Congress, and make public, a report regarding the implementation of part C of
title XI of the Social Security Act [42 U.S.C.
1320d et seq.]. Such report shall address the following subjects, to the extent that the Committee determines appropriate:
(A) The extent to which persons required to
comply with part C of title XI of the Social
Security Act are cooperating in implementing
the standards adopted under such part.
(B) The extent to which such entities are
meeting the security standards adopted under
such part and the types of penalties assessed
for noncompliance with such standards.
(C) Whether the Federal and State Governments are receiving information of sufficient
quality to meet their responsibilities under
such part.
(D) Any problems that exist with respect to
implementation of such part.

Page 130

(E) The extent to which timetables under
such part are being met.
(l) Data specific to particular ethnic and racial
populations
In carrying out this section, the Secretary,
acting through the Center, shall collect and analyze adequate health data that is specific to particular ethnic and racial populations, including
data collected under national health surveys.
Activities carried out under this subsection
shall be in addition to any activities carried out
under subsection (m) of this section.
(m) Grants for assembly and analysis of data on
ethnic and racial populations
(1) The Secretary, acting through the Center,
may make grants to public and nonprofit private entities for—
(A) the conduct of special surveys or studies
on the health of ethnic and racial populations
or subpopulations;
(B) analysis of data on ethnic and racial populations and subpopulations; and
(C) research on improving methods for developing statistics on ethnic and racial populations and subpopulations.
(2) The Secretary, acting through the Center,
may provide technical assistance, standards,
and methodologies to grantees supported by this
subsection in order to maximize the data quality and comparability with other studies.
(3) Provisions of section 242m(d) of this title
do not apply to surveys or studies conducted by
grantees under this subsection unless the Secretary, in accordance with regulations the Secretary may issue, determines that such provisions are necessary for the conduct of the survey
or study and receives adequate assurance that
the grantee will enforce such provisions.
(4)(A) Subject to subparagraph (B), the Secretary, acting through the Center, shall collect
data on Hispanics and major Hispanic subpopulation groups and American Indians, and for
developing special area population studies on
major Asian American and Pacific Islander populations.
(B) The provisions of subparagraph (A) shall be
effective with respect to a fiscal year only to the
extent that funds are appropriated pursuant to
paragraph (3) of subsection (n) of this section,
and only if the amounts appropriated for such
fiscal year pursuant to each of paragraphs (1)
and (2) of subsection (n) of this section equal or
exceed the amounts so appropriated for fiscal
year 1997.
(n) Authorization of appropriations
(1) For health statistical and epidemiological
activities undertaken or supported under subsections (a) through (l) of this section, there are
authorized to be appropriated such sums as may
be necessary for each of the fiscal years 1991
through 2003.
(2) For activities authorized in paragraphs (1)
through (3) of subsection (m) of this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 1999 through 2003. Of such amounts, the
Secretary shall use not more than 10 percent for
administration and for activities described in
subsection (m)(2) of this section.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) For activities authorized in subsection
(m)(4) of this section, there are authorized to be
appropriated $1,000,000 for fiscal year 1998, and
such sums as may be necessary for each of the
fiscal years 1999 through 2002.
(July 1, 1944, ch. 373, title III, § 306, as added Pub.
L. 93–353, title I, § 105, July 23, 1974, 88 Stat. 365;
amended Pub. L. 95–623, §§ 5, 8(a), Nov. 9, 1978, 92
Stat. 3445, 3453; Pub. L. 97–35, title IX, § 920, Aug.
13, 1981, 95 Stat. 566; Pub. L. 97–414, § 8(b), Jan. 4,
1983, 96 Stat. 2060; Pub. L. 100–177, title I, §§ 104,
105(a), Dec. 1, 1987, 101 Stat. 988; Pub. L. 101–239,
title VI, § 6103(e)(2), Dec. 19, 1989, 103 Stat. 2206;
Pub. L. 101–527, § 7(a), (b)(1), (c), Nov. 6, 1990, 104
Stat. 2327, 2328; Pub. L. 102–54, § 13(q)(1)(A)(i),
June 13, 1991, 105 Stat. 278; Pub. L. 103–183, title
V, § 501(a), (d), Dec. 14, 1993, 107 Stat. 2237, 2238;
Pub. L. 104–191, title II, § 263, Aug. 21, 1996, 110
Stat. 2031; Pub. L. 105–340, title II, § 201, Oct. 31,
1998, 112 Stat. 3193; Pub. L. 105–392, title II,
§ 201(b), Nov. 13, 1998, 112 Stat. 3585.)
REFERENCES IN TEXT
Section 3509 of title 44, referred to in subsec. (j)(4), (5),
which required submission of certain plans and forms
for collection of information to the Director of the Office of Management and Budget for approval, was omitted in the general amendment of chapter 35 of Title 44,
Public Printing and Documents, by Pub. L. 96–511,
§ 2(a), Dec. 11, 1980, 94 Stat. 2812. Pub. L. 104–13 subsequently enacted a new section 3509 of Title 44 relating
to designation of a central collection agency. Provisions appearing in former section 3509 are contained in
section 3507 of Title 44.
The Social Security Act, referred to in subsec.
(k)(5)(A)(viii), (D), (7), is act Aug. 14, 1935, ch. 531, 49
Stat. 620, as amended. Part C of title XI of the Act is
classified generally to part C (§ 1320d et seq.) of subchapter XI of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of
this title and Tables.
CODIFICATION
In subsec. (f), ‘‘section 6101 of title 41’’ substituted for
‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’ on
authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.
PRIOR PROVISIONS
Provisions similar to those comprising subsec. (g) of
this section were contained in section 313 of act July 1,
1944, ch. 373, title III, 58 Stat. 693; Oct. 30, 1970, Pub. L.
91–516, title II, § 282, 84 Stat. 1308 (formerly classified to
section 245 of this title), prior to repeal by Pub. L.
93–353, § 102(a).
Provisions similar to those comprising subsec. (h) of
this section were contained in section 312a of act July
1, 1944, ch. 373, title III, as added Aug. 31, 1954, ch. 1158,
§ 2, 68 Stat. 1025 (formerly classified to section 244a of
this title), prior to repeal by Pub. L. 93–353, § 102(a).
AMENDMENTS
1998—Subsec. (m)(4). Pub. L. 105–392, § 201(b)(1), added
par. (4).
Subsec. (n)(1). Pub. L. 105–340, § 201(1), and Pub. L.
105–392, § 201(b)(2), amended par. (1) identically, substituting ‘‘2003’’ for ‘‘1998’’.
Subsec. (n)(2). Pub. L. 105–392, § 201(b)(3)(A), in first
sentence, substituted ‘‘paragraphs (1) through (3) of
subsection (m)’’ for ‘‘subsection (m)’’ and substituted
‘‘such sums as may be necessary for each of the fiscal
years 1999 through 2003.’’ for ‘‘$5,000,000 for fiscal year
1991, $7,500,000 for fiscal year 1992, $10,000,000 for fiscal
year 1993, and $10,000,000 for each of the fiscal years 1994
through 2003.’’
Pub. L. 105–340, § 201(2), substituted ‘‘2003’’ for ‘‘1998’’.

§ 242k

Subsec. (n)(3). Pub. L. 105–392, § 201(b)(3)(B), added par.
(3).
1996—Subsec. (k)(1). Pub. L. 104–191, § 263(1), substituted ‘‘18’’ for ‘‘16’’.
Subsec. (k)(2). Pub. L. 104–191, § 263(2), amended par.
(2) generally. Prior to amendment, par. (2) read as follows: ‘‘The members of the Committee shall be appointed by the Secretary from among persons who have
distinguished themselves in the fields of health statistics, health planning, epidemiology, and the provision
of health services. Members of the Committee shall be
appointed for terms of 4 years.’’
Subsec. (k)(3), (4). Pub. L. 104–191, § 263(3), added par.
(3) and redesignated former par. (3) as (4). Former par.
(4) redesignated (5).
Subsec. (k)(5). Pub. L. 104–191, § 263(4), amended par.
(5) generally. Prior to amendment, par. (5) consisted of
subpars. (A) to (G) relating to Committee functions in
assisting and advising the Secretary.
Pub. L. 104–191, § 263(3), redesignated par. (4) as (5).
Former par. (5) redesignated (6).
Subsec. (k)(6). Pub. L. 104–191, § 263(3), redesignated
par. (5) as (6).
Subsec. (k)(7). Pub. L. 104–191, § 263(5), added par. (7).
1993—Subsec. (c). Pub. L. 103–183, § 501(a)(1), substituted ‘‘Committee on Labor and Human Resources’’
for ‘‘Committee on Human Resources’’.
Subsec. (g). Pub. L. 103–183, § 501(a)(2), substituted
‘‘data’’ for ‘‘data which shall be published as a part of
the health reports published by the Secretary’’.
Subsec. (i). Pub. L. 103–183, § 501(a)(3), struck out ‘‘engaged in health planning activities’’ after ‘‘entities’’.
Subsec. (k)(2). Pub. L. 103–183, § 501(a)(4), struck out
subpar. (A) designation, substituted ‘‘Members’’ for
‘‘Except as provided in subparagraph (B), members’’,
and struck out subpar. (B) which related to extensions
of membership terms of members of National Committee on Vital and Health Statistics whose terms were to
expire in calendar years 1988, 1989, and 1990.
Subsec. (l). Pub. L. 103–183, § 501(a)(5)(A)–(C), redesignated subsec. (m) as (l), substituted ‘‘subsection (m)’’
for ‘‘subsection (n)’’, and struck out former subsec. (l)
which related to development of plan for collection and
coordination of statistical and epidemiological data on
effects of environment on health and establishment of
guidelines for compilation, analysis, and distribution of
statistics and information necessary for coordinated
determination of effects of conditions of employment
and indoor and outdoor environmental conditions on
public health.
Subsec. (m). Pub. L. 103–183, § 501(a)(5)(B), redesignated subsec. (n) as (m). Former subsec. (m) redesignated (l).
Subsecs. (n), (o). Pub. L. 103–183, § 501(a)(5)(B), (D), (d),
redesignated subsec. (o) as (n), in par. (1) substituted
‘‘(l)’’ for ‘‘(m)’’ and ‘‘1998’’ for ‘‘1993’’, and in par. (2)
substituted ‘‘(m)’’ for ‘‘(n)’’, struck out ‘‘and’’ after
‘‘1992,’’, inserted ‘‘, and $10,000,000 for each of the fiscal
years 1994 through 1998’’, and substituted ‘‘(m)(2)’’ for
‘‘(n)(2)’’. Former subsec. (n) redesignated (m).
1991—Subsec. (k)(4)(C). Pub. L. 102–54 substituted
‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1990—Subsec. (h). Pub. L. 101–527, § 7(a), designated existing text as par. (1), inserted after second sentence
‘‘The Secretary shall encourage States and registration
areas to obtain detailed data on ethnic and racial populations, including subpopulations of Hispanics, Asian
Americans, and Pacific Islanders with significant representation in the State or registration area.’’, and
added par. (2).
Subsecs. (m) to (o). Pub. L. 101–527, § 7(b)(1), (c), added
subsecs. (m) and (n) and redesignated former subsec.
(m) as (o) and amended it generally. Prior to amendment, subsec. (o) read as follows: ‘‘For health statistical and epidemiological activities undertaken or supported under this section, there are authorized to be
appropriated $55,000,000 for fiscal year 1988 and such
sums as may be necessary for each of the fiscal years
1989 and 1990.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

1989—Subsec. (a). Pub. L. 101–239, § 6103(e)(2)(A), inserted at end ‘‘The Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in
the United States.’’
Subsec. (b). Pub. L. 101–239, § 6103(e)(2)(B), substituted
‘‘subsection (a) of this section’’ for ‘‘section 242b(a) of
this title’’.
Subsec. (m). Pub. L. 101–239, § 6103(e)(2)(C), added subsec. (m).
1987—Subsec. (a). Pub. L. 100–177, § 104, struck out
‘‘and supervised by the Assistant Secretary for Health
(or such other officer of the Department as may be designated by the Secretary as the principal adviser to
him for health programs)’’.
Subsec. (k)(1). Pub. L. 100–177, § 105(a)(1), substituted
‘‘16 members’’ for ‘‘fifteen members’’.
Subsec. (k)(2)(A). Pub. L. 100–177, § 105(a)(2), substituted ‘‘terms of 4 years’’ for ‘‘terms of three years’’.
Subsec. (k)(2)(B). Pub. L. 100–177, § 105(a)(3), added
subpar. (B) and struck out former subpar. (B) which
read as follows: ‘‘Of the members first appointed—
‘‘(i) five shall be appointed for terms of one year,
‘‘(ii) five shall be appointed for terms of two years,
and
‘‘(iii) five shall be appointed for terms of three
years,
as designated by the Secretary at the time of appointment. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which his
predecessor was appointed shall be appointed only for
the remainder of such term. A member may serve after
the expiration of his term until his successor has taken
office.’’
1983—Subsec. (l)(2)(D). Pub. L. 97–414 redesignated
subpar. (E) as (D) and struck out former subpar. (D)
which provided that the Center would serve as a clearinghouse for statistics and information with respect to
which guidelines had been established under subpar.
(A).
Subsec. (l)(2)(E) to (G). Pub. L. 97–414 redesignated
subpars. (F) and (G) as (E) and (F), respectively.
Former subpar. (E) redesignated (D).
1981—Subsec. (a). Pub. L. 97–35, § 920(d)(1), substituted
‘‘Health and Human Services’’ for ‘‘Health, Education,
and Welfare’’.
Subsec. (c). Pub. L. 97–35, § 920(d)(2), substituted ‘‘Energy and’’ for ‘‘Interstate and Foreign’’.
Subsec. (e). Pub. L. 97–35, § 920(a), (d)(1), in par. (3) inserted applicability to other activities, and in par. (4)
substituted ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’.
Subsecs. (j), (k)(4)(C), (D). Pub. L. 97–35, § 920(d)(1),
substituted ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’.
Subsec. (l)(2). Pub. L. 97–35, § 920(b), (c), (d)(1), in subpar. (A) inserted reference to Office of Federal Statistical Policy and Standards, in subpar. (B)(v) substituted ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’, and in subpar. (D) struck out
provisions relating to assistance to executive departments.
1978—Subsec. (b). Pub. L. 95–623, § 5(a), struck out
‘‘may’’ after ‘‘through the Center,’’, substituted in
pars. (1) and (2) ‘‘shall collect’’ and ‘‘shall undertake’’
for ‘‘collect’’ and ‘‘undertake’’, respectively, and added
pars. (3) and (4) and provision for availability of certain
appropriated funds from par. (4) payments until expended.
Subsec. (c). Pub. L. 95–623, § 5(b), substituted ‘‘statistical and epidemiological compilations’’ for ‘‘statistical compilations’’ in two places and ‘‘Committee on
Human Resources’’ for ‘‘Committee on Labor and Public Welfare’’ of the Senate.
Subsec. (e). Pub. L. 95–623, § 5(c)(1), incorporated in introductory text prior cl. (1) provision requiring the Secretary to assist State and local health agencies and
Federal agencies involved in health matters in the design and implementation of a cooperative system for

Page 132

producing comparable and uniform health information
and statistics at the Federal, State, and local levels;
enacted in pars. (1) and (2) provisions almost identical
to prior cls. (2) and (3); enacted par. (3); struck out
former cl. (4) provision for the Federal share of the data
collection costs under the system; enacted in par. (4)
provisions almost identical to former cl. (5); and required State designation of a State administrative
agency to be responsible for the statistical activities
within the State under the System and Federal guidelines for production of uniform and timely data and appropriate access to the data.
Subsec. (f). Pub. L. 95–623, § 5(d), substituted ‘‘the Secretary, acting through the Center, shall cooperate and
consult’’ for ‘‘the Secretary shall cooperate and consult’’.
Subsecs. (i), (j). Pub. L. 95–623, § 5(f), added subsecs. (i)
and (j). Former subsec. (i) redesignated (k).
Subsec. (k). Pub. L. 95–623, § 5(c)(2), (e), (f), struck
from par. (1) ‘‘United States’’ before ‘‘National Committee on Vital and Health Statistics’’; authorized in
par. (2)(A) the appointment of Committee members
from distinguished persons in field of health planning;
required the Committee to assist and advise the Secretary with respect to the Cooperative Health Statistics System and the standardized means for the collection of health information and statistics to be established by the Secretary; and redesignated such amended subsec. (i) as (k).
Subsec. (l). Pub. L. 95–623, § 8(a), added subsec. (l).
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 12 of Pub. L. 101–527 provided that: ‘‘This Act
and the amendments made by this Act [enacting sections 254c–1, 254t, 256a, 294bb, 294cc, and 300u–6 of this
title, amending this section and sections 242m, 254b,
254c, 294m, 294o, and 295g–2 of this title, enacting provisions set out as notes under sections 201 and 300u–6 of
this title, and repealing provisions set out as a note
under section 292h of this title] shall take effect October 1, 1990, or upon the date of the enactment of this
Act [Nov. 6, 1990], whichever occurs later.’’
EFFECTIVE DATE OF 1987 AMENDMENT
Section 105(b) of Pub. L. 100–177 provided that: ‘‘The
amendments made by this section [amending this section] shall become effective on January 1, 1988.’’
MONEY RECEIVED BY CENTER FROM REIMBURSEMENTS,
INTERAGENCY AGREEMENTS, AND SALE OF DATA
TAPES TO REMAIN AVAILABLE UNTIL EXPENDED
Pub. L. 103–333, title II, Sept. 30, 1994, 108 Stat. 2550,
provided in part: ‘‘That for fiscal year 1995 and subsequent fiscal years amounts received by the National
Center for Health Statistics from reimbursements and
interagency agreements and the sale of data tapes may
be credited to this appropriation and shall remain
available until expended’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 242l. International cooperation
(a) Cooperative endeavors
The Secretary may participate with other
countries in cooperative endeavors in—
(1) biomedical research, health care technology, and the health services research and
statistical analysis authorized under section
242k of this title and subchapter VII; and
(2) biomedical research, health care services,
health care research, or other related activities in furtherance of the activities, objectives
or goals authorized under the Tom Lantos and
Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.
(b) Authority of Secretary; building construction
prohibition
In connection with the cooperative endeavors
authorized by subsection (a) of this section, the
Secretary may—
(1) make such use of resources offered by
participating foreign countries as he may find
necessary and appropriate;
(2) establish and maintain fellowships in the
United States and in participating foreign
countries;
(3) make grants to public institutions or
agencies and to nonprofit private institutions
or agencies in the United States and in participating foreign countries for the purpose of
establishing and maintaining the fellowships
authorized by paragraph (2);
(4) make grants or loans of equipment and
materials, for use by public or nonprofit institutions or agencies, or by individuals, in participating foreign countries;
(5) participate and otherwise cooperate in
any international meetings, conferences, or
other activities concerned with biomedical research, health services research, health statistics, or health care technology;
(6) facilitate the interchange between the
United States and participating foreign countries, and among participating foreign countries, of research scientists and experts who
are engaged in experiments or programs of
biomedical research, health services research,
health statistical activities, or health care
technology activities, and in carrying out
such purpose may pay per diem compensation,
subsistence, and travel for such scientists and
experts when away from their places of residence at rates not to exceed those provided in
section 5703(b) 1 of title 5 for persons in the
Government service employed intermittently;
(7) procure, in accordance with section 3109
of title 5, the temporary or intermittent services of experts or consultants;
(8) enter into contracts with individuals for
the provision of services (as defined in section
104 of part 37 of title 48, Code of Federal Regulations (48 CFR 37.104)) in participating foreign
countries, which individuals may not be
deemed employees of the United States for the
purpose of any law administered by the Office
of Personnel Management;
(9) provide such funds by advance or reimbursement to the Secretary of State, as may
1 See

References in Text note below.

§ 242l

be necessary, to pay the costs of acquisition,
lease, construction, alteration, equipping, furnishing or management of facilities outside of
the United States; and
(10) in consultation with the Secretary of
State, through grant or cooperative agreement, make funds available to public or nonprofit private institutions or agencies in foreign countries in which the Secretary is participating in activities described under subsection (a) to acquire, lease, construct, alter,
or renovate facilities in those countries.
(c) Benefits for overseas assignees
The Secretary may provide to personnel appointed or assigned by the Secretary to serve
abroad, allowances and benefits similar to those
provided under chapter 9 of title I of the Foreign
Service Act of 1980 (22 U.S.C. 4081 et seq.).
Leaves of absence for personnel under this subsection shall be on the same basis as that provided under subchapter I of chapter 63 of title 5
or section 903 of the Foreign Service Act of 1980
(22 U.S.C. 4083) to individuals serving in the Foreign Service.
(d) Strategies to improve injection safety
In carrying out immunization programs and
other programs in developing countries for the
prevention, treatment, and control of infectious
diseases, including HIV/AIDS, tuberculosis, and
malaria, the Director of the Centers for Disease
Control and Prevention, in coordination with
the Coordinator of United States Government
Activities to Combat HIV/AIDS Globally, the
National Institutes of Health, national and local
government, and other organizations, such as
the World Health Organization and the United
Nations Children’s Fund, shall develop and implement effective strategies to improve injection safety, including eliminating unnecessary
injections, promoting sterile injection practices
and technologies, strengthening the procedures
for proper needle and syringe disposal, and improving the education and information provided
to the public and to health professionals.
(July 1, 1944, ch. 373, title III, § 307, formerly
§ 308, as added Pub. L. 86–610, § 3, July 12, 1960, 74
Stat. 364; renumbered § 307 and amended Pub. L.
93–353, title I, § 106, July 23, 1974, 88 Stat. 367;
Pub. L. 97–35, title IX, § 921, Aug. 13, 1981, 95 Stat.
566; Pub. L. 101–239, title VI, § 6103(e)(3), Dec. 19,
1989, 103 Stat. 2206; Pub. L. 102–531, title III, § 310,
Oct. 27, 1992, 106 Stat. 3503; Pub. L. 103–183, title
VII, § 702, Dec. 14, 1993, 107 Stat. 2239; Pub. L.
108–25, title III, § 306, May 27, 2003, 117 Stat. 739;
Pub. L. 110–293, title II, § 205, July 30, 2008, 122
Stat. 2943.)
REFERENCES IN TEXT
The Tom Lantos and Henry J. Hyde United States
Global Leadership Against HIV/AIDS, Tuberculosis,
and Malaria Reauthorization Act of 2008, referred to in
subsec. (a)(2), is Pub. L. 110–293, July 30, 2008, 122 Stat.
2918. For complete classification of this Act to the
Code, see Short Title of 2008 Amendment note set out
under section 7601 of Title 22, Foreign Relations and
Intercourse, and Tables.
Section 5703 of title 5, referred to in subsec. (b)(6),
was amended generally by Pub. L. 94–22, § 4, May 19,
1975, 89 Stat. 85, and, as so amended, does not contain
a subsec. (b).
The Foreign Service Act of 1980, referred to in subsec.
(c), is Pub. L. 96–465, Oct. 17, 1980, 94 Stat. 2071. Chapter

§ 242m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

9 of title I of the Act is classified generally to subchapter IX (§ 4081 et seq.) of chapter 52 of Title 22, Foreign Relations and Intercourse. For complete classification of this Act to the Code, see Short Title note
set out under section 3901 of Title 22 and Tables.
CODIFICATION
Section was formerly classified to section 242f of this
title.
PRIOR PROVISIONS
A prior section 307 of act July 1, 1944, was classified
to section 242e of this title, prior to repeal by Pub. L.
93–353, title I, § 102(a), July 23, 1974, 88 Stat. 362.
AMENDMENTS
2008—Subsec. (a). Pub. L. 110–293, § 205(1), amended
subsec. (a) generally. Prior to amendment, text read as
follows: ‘‘For the purpose of advancing the status of the
health sciences in the United States (and thereby the
health of the American people), the Secretary may participate with other countries in cooperative endeavors
in biomedical research, health care technology, and the
health services research and statistical activities authorized by section 242k of this title and by subchapter
VII of this chapter.’’
Subsec. (b). Pub. L. 110–293, § 205(2)(B), struck out concluding provisions which read as follows: ‘‘The Secretary may not, in the exercise of his authority under
this section, provide financial assistance for the construction of any facility in any foreign country.’’
Subsec. (b)(8). Pub. L. 110–293, § 205(2)(C), substituted
‘‘for the purpose of any law administered by the Office
of Personnel Management;’’ for ‘‘for any purpose.’’
Subsec. (b)(9), (10). Pub. L. 110–293, § 205(2)(A), (D),
added pars. (9) and (10).
Subsec. (c). Pub. L. 110–293, § 205(3), substituted ‘‘1980’’
for ‘‘1990’’ and inserted ‘‘or section 903 of the Foreign
Service Act of 1980 (22 U.S.C. 4083)’’ after ‘‘title 5’’.
2003—Subsec. (d). Pub. L. 108–25 added subsec. (d).
1993—Subsec. (c). Pub. L. 103–183 added subsec. (c).
1992—Subsec. (b)(8). Pub. L. 102–531, which directed
amendment of subsec. (b) by adding par. (8) at the end
thereof, was executed by adding par. (8) after par. (7) to
reflect the probable intent of Congress.
1989—Subsec. (a). Pub. L. 101–239 substituted ‘‘section
242k of this title and by subchapter VII of this chapter’’
for ‘‘sections 242b, 242c, 242k, and 242n of this title’’.
1981—Subsec. (a). Pub. L. 97–35, § 921(a), inserted reference to health care technology and section 242n of
this title.
Subsec. (b). Pub. L. 97–35, § 921(b), in par. (5) inserted
reference to health care technology, and in par. (6) inserted reference to health care technology activities.
1974—Pub. L. 93–353 amended section generally.
INTERNATIONAL HEALTH STUDY
Pub. L. 95–83, title III, § 315, Aug. 1, 1977, 91 Stat. 398,
provided that the Secretary of Health, Education, and
Welfare arrange through the National Academy of Sciences or other nonprofit private groups or associations,
for a study to determine opportunities for broadened
Federal program activities in areas of international
health, which study was to consider biomedical and behavioral research, health services research, health professions education, immunization and public health activities, and other areas that might improve our and
other nations’ capacities to prevent, diagnose, control,
or cure disease, and to organize and deliver effective
and efficient health services, with an interim report on
such study completed no later than Oct. 1, 1977 and a
final report completed no later than Jan. 1, 1978 and
both reports submitted to the Secretary, the Committee on Human Resources of the Senate, and the Committee on Interstate and Foreign Commerce of the
House of Representatives.

Page 134

§ 242m. General provisions respecting effectiveness, efficiency, and quality of health services
(a) Reports to Congress and President; preparation; review by Office of Management and
Budget
(1) Not later than March 15 of each year, the
Secretary shall submit to the President and
Congress the following reports:
(A) A report on health care costs and financing. Such report shall include a description
and analysis of the statistics collected under
section 242k(b)(1)(G) of this title.
(B) A report on health resources. Such report shall include a description and analysis,
by geographical area, of the statistics collected under section 242k(b)(1)(E) of this title.
(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
section 242k(b)(1)(F) of this title.
(D) A report on the health of the Nation’s
people. Such report shall include a description
and analysis, by age, sex, income, and geographic area, of the statistics collected under
section 242k(b)(1)(A) of this title.
(2) The reports required in paragraph (1) shall
be prepared through the National Center for
Health Statistics.
(3) The Office of Management and Budget may
review any report required by paragraph (1) of
this subsection before its submission to Congress, but the Office may not revise any such report or delay its submission beyond the date
prescribed for its submission, and may submit to
Congress its comments respecting any such report.
(b) Grants or contracts; applications, submittal;
application peer review group, findings and
recommendations; necessity of favorable recommendation; appointments
(1) No grant or contract may be made under
section 242b, 242k, or 242l of this title unless an
application therefor has been submitted to the
Secretary in such form and manner, and containing such information, as the Secretary may
by regulation prescribe and unless a peer review
group referred to in paragraph (2) has recommended the application for approval.
(2)(A) Each application submitted for a grant
or contract under section 242k of this title in an
amount exceeding $50,000 of direct costs and for
a health services research, evaluation, or demonstration project, or for a grant under section
242k(m) of this title, shall be submitted to a peer
review group for an evaluation of the technical
and scientific merits of the proposals made in
each such application. The Director of the National Center for Health Statistics shall establish such peer review groups as may be necessary to provide for such an evaluation of each
such application.
(B) A peer review group to which an application is submitted pursuant to subparagraph (A)
shall report its finding and recommendations respecting the application to the Secretary, acting
through the Director of the National Center for
Health Statistics, in such form and manner as

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Secretary shall by regulation prescribe. The
Secretary may not approve an application described in such subparagraph unless a peer review group has recommended the application for
approval.
(C) The Secretary, acting through the Director
of the National Center for Health Statistics,
shall make appointments to the peer review
groups required in subparagraph (A) from among
persons who are not officers or employees of the
United States and who possess appropriate technical and scientific qualifications, except that
peer review groups regarding grants under section 242k(m) of this title may include appropriately qualified such officers and employees.
(c) Development and dissemination of statistics
The Secretary shall take such action as may
be necessary to assure that statistics developed
under sections 242b and 242k of this title are of
high quality, timely, comprehensive as well as
specific, standardized, and adequately analyzed
and indexed, and shall publish, make available,
and disseminate such statistics on as wide a
basis as is practicable.
(d) Information; publication restrictions
No information, if an establishment or person
supplying the information or described in it is
identifiable, obtained in the course of activities
undertaken or supported under section 242b,
242k, or 242l of this title may be used for any
purpose other than the purpose for which it was
supplied unless such establishment or person
has consented (as determined under regulations
of the Secretary) to its use for such other purpose; and in the case of information obtained in
the course of health statistical or epidemiological activities under section 242b or 242k of this
title, such information may not be published or
released in other form if the particular establishment or person supplying the information or
described in it is identifiable unless such establishment or person has consented (as determined
under regulations of the Secretary) to its publication or release in other form.
(e) Payment procedures; advances or reimbursement; installments; conditions; reductions
(1) Payments of any grant or under any contract under section 242b, 242k, or 242l of this title
may be made in advance or by way of reimbursement, and in such installments and on such conditions, as the Secretary deems necessary to
carry out the purposes of such section.
(2) The amounts otherwise payable to any person under a grant or contract made under section 242b, 242k, or 242l of this title shall be reduced by—
(A) amounts equal to the fair market value
of any equipment or supplies furnished to such
person by the Secretary for the purpose of carrying out the project with respect to which
such grant or contract is made, and
(B) amounts equal to the pay, allowances,
traveling expenses, and related personnel expenses attributable to the performance of
services by an officer or employee of the Government in connection with such project, if
such officer or employee was assigned or detailed by the Secretary to perform such services,

§ 242m

but only if such person requested the Secretary
to furnish such equipment or supplies, or such
services, as the case may be.
(f) Contracts without regard to section 3324 of
title 31 and section 6101 of title 41
Contracts may be entered into under section
242b or 242k of this title without regard to section 3324 of title 31 and section 6101 of title 41.
(July 1, 1944, ch. 373, title III, § 308, as added Pub.
L. 93–353, title I, § 107(a), July 23, 1974, 88 Stat.
368; amended Pub. L. 94–273, § 7(2), Apr. 21, 1976,
90 Stat. 378; Pub. L. 95–83, title I, § 104, Aug. 1,
1977, 91 Stat. 384; Pub. L. 95–623, §§ 2, 6(d), 8(b),
Nov. 9, 1978, 92 Stat. 3443, 3451, 3455; Pub. L. 97–35,
title IX, §§ 917(a), (b), 919(a)(2)(B), 922, Aug. 13,
1981, 95 Stat. 564, 565, 567; Pub. L. 97–414, § 8(c),
Jan. 4, 1983, 96 Stat. 2060; Pub. L. 98–551, § 7, Oct.
30, 1984, 98 Stat. 2820; Pub. L. 100–177, title I,
§§ 106(a), 107, 108, Dec. 1, 1987, 101 Stat. 988–990;
Pub. L. 100–690, title II, § 2612, Nov. 18, 1988, 102
Stat. 4235; Pub. L. 101–239, title VI, § 6103(e)(4),
Dec. 19, 1989, 103 Stat. 2206; Pub. L. 101–527,
§ 7(b)(2), (d), Nov. 6, 1990, 104 Stat. 2328; Pub. L.
103–183, title V, § 501(c), Dec. 14, 1993, 107 Stat.
2237; Pub. L. 105–392, title IV, § 401(d), Nov. 13,
1998, 112 Stat. 3587.)
CODIFICATION
In subsec. (f), ‘‘section 6101 of title 41’’ substituted for
‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’ on
authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.
PRIOR PROVISIONS
Provisions similar to those comprising subsec. (e) of
this section were contained in subsec. (a)(3) of section
304 of act July 1, 1944, ch. 373, title III, as added July
28, 1955, ch. 417, § 3, 69 Stat. 382, and amended (formerly
classified to section 242b(a)(3) of this title), prior to
general amendment of section 304 by Pub. L. 93–353,
§ 103.
AMENDMENTS
1998—Subsec. (b)(2)(A), (C). Pub. L. 105–392 substituted
‘‘242k(m)’’ for ‘‘242k(n)’’.
1993—Subsec. (a)(1). Pub. L. 103–183, § 501(c)(1)(A), redesignated subpars. (B) to (E) as (A) to (D), respectively, and struck out former subpar. (A) which read as
follows: ‘‘A report on—
‘‘(i) the administration of sections 242b, 242k, and
242l of this title and subchapter VII of this chapter
during the preceding fiscal year; and
‘‘(ii) the current state and progress of health services research, health statistics, and health care technology.’’
Subsec. (a)(2). Pub. L. 103–183, § 501(c)(1)(B), substituted ‘‘reports required in paragraph (1) shall be prepared through the National Center’’ for ‘‘reports required by subparagraphs (B) through (E) of paragraph
(2) shall be prepared through the Agency for Health
Care Policy and Research and the National Center’’.
Subsec. (c). Pub. L. 103–183, § 501(c)(2)(A)–(D), (3), redesignated subsec. (g)(2) as subsec. (c), substituted
‘‘shall take’’ for ‘‘shall (A) take’’ and ‘‘and shall publish’’ for ‘‘and (B) publish’’, and struck out former subsec. (c) which read as follows: ‘‘The aggregate number
of grants and contracts made or entered into under sections 242b and 242c of this title for any fiscal year respecting a particular means of delivery of health services or another particular aspect of health services may
not exceed twenty; and the aggregate amount of funds
obligated under grants and contracts under such sections for any fiscal year respecting a particular means
of delivery of health services or another particular aspect of health services may not exceed $5,000,000.’’

§ 242m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (f). Pub. L. 103–183, § 501(c)(4), substituted
‘‘section 3324 of title 31 and section 5 of title 41’’ for
‘‘sections 3648 and 3709 of the Revised Statutes (31
U.S.C. 529; 41 U.S.C. 5)’’.
Subsec. (g). Pub. L. 103–183, § 501(c)(2)(B), (C), (E), redesignated par. (2) as subsec. (c) and struck out par. (1)
which read as follows: ‘‘The Secretary shall—
‘‘(A) publish, make available and disseminate,
promptly in understandable form and on as broad a
basis as practicable, the results of health services research, demonstrations, and evaluations undertaken
and supported under sections 242b and 242c of this
title;
‘‘(B) make available to the public data developed in
such research, demonstrations, and evaluations; and
‘‘(C) provide indexing, abstracting, translating,
publishing, and other services leading to a more effective and timely dissemination of information on
health services research, demonstrations, and evaluations in health care delivery to public and private entities and individuals engaged in the improvement of
health care delivery and the general public; and undertake programs to develop new or improved methods for making such information available.’’
Subsec. (h). Pub. L. 103–183, § 501(c)(5), struck out subsec. (h) which read as follows:
‘‘(1) Except where the Secretary determines that unusual circumstances make a larger percentage necessary in order to effectuate the purposes of section
242k of this title, a grant or contract under any of such
sections of this title with respect to any project for
construction of a facility or for acquisition of equipment may not provide for payment of more than 50 per
centum of so much of the cost of the facility or equipment as the Secretary determines is reasonably attributable to research, evaluation, or demonstration purposes.
‘‘(2) Laborers and mechanics employed by contractors
and subcontractors in the construction of such a facility shall be paid wages at rates not less than those prevailing on similar work in the locality, as determined
by the Secretary of Labor in accordance with the Act
of March 3, 1931 (40 U.S.C. 267a—267a–5, known as the
Davis-Bacon Act); and the Secretary of Labor shall
have with respect to any labor standards specified in
this paragraph the authority and functions set forth in
Reorganization Plan Numbered 14 of 1950 (5 U.S.C. Appendix) and section 276c of title 40.
‘‘(3) Such grants and contracts shall be subject to
such additional requirements as the Secretary may by
regulation prescribe.’’
1990—Subsec. (b)(2)(A). Pub. L. 101–527, § 7(b)(2)(A), inserted ‘‘or for a grant under section 242k(n) of this
title,’’ after ‘‘demonstration project,’’.
Subsec. (b)(2)(C). Pub. L. 101–527, § 7(b)(2)(B), inserted
before period at end ‘‘, except that peer review groups
regarding grants under section 242k(n) of this title may
include appropriately qualified such officers and employees’’.
Subsec. (b)(3). Pub. L. 101–527, § 7(d), struck out par.
(3) which related to applications submitted under section 242k of this title for which a grant or contract may
be made under another provision of this chapter.
1989—Pub. L. 101–239, § 6103(e)(4)(A), amended section
catchline.
Subsec. (a)(1)(A)(i). Pub. L. 101–239, § 6103(e)(4)(B)(i),
substituted ‘‘sections 242b, 242k, and 242l of this title
and subchapter VII of this chapter’’ for ‘‘sections 242b,
242c, 242k, and 242l of this title and section 242n of this
title’’.
Subsec. (a)(2). Pub. L. 101–239, § 6103(e)(4)(B)(ii), substituted ‘‘the Agency for Health Care Policy and Research’’ for ‘‘the National Center for Health Services
Research and Health Care Technology Assessment’’.
Subsec. (b)(1). Pub. L. 101–239, § 6103(e)(4)(C)(i), which
directed amendment of par. (1) by substituting ‘‘section
242b, 242k, or 242l of this title’’ for ‘‘sections 242b, 242c,
242k, 242l, and 242n of this title’’, was executed by making the substitution for ‘‘section 242b, 242c, 242k, 242l, or
242n of this title’’ as the probable intent of Congress.

Page 136

Subsec. (b)(2)(A). Pub. L. 101–239, § 6103(e)(4)(C)(ii),
substituted ‘‘under section 242k of this title’’ for
‘‘under section 242b or 242c of this title,’’ in first sentence, struck out second sentence which read as follows: ‘‘Each application for a grant, contract, or cooperative agreement in an amount exceeding $50,000 of direct costs for the dissemination of research findings or
the development of research agendas (including conferences, workshops, and meetings) shall be submitted
to a standing peer review group with persons with appropriate expertise and shall not be submitted to any
peer review group established to review applications for
research, evaluation, or demonstration projects.’’, and
amended last sentence generally. Prior to amendment,
last sentence read as follows: ‘‘The Secretary, acting
through the Director of the National Center for Health
Services Research and Health Care Technology Assessment (or, as appropriate, through the Director of the
National Center for Health Statistics), shall establish
such peer review groups as may be necessary to provide
for such an evaluation of an application described in
the first two sentences of this subparagraph.’’
Subsec. (b)(2)(B). Pub. L. 101–239, § 6103(e)(4)(C)(iii),
substituted ‘‘the Director of the National Center for
Health Statistics’’ for ‘‘the Director involved’’.
Subsec. (b)(2)(C). Pub. L. 101–239, § 6103(e)(4)(C)(iv),
substituted ‘‘the Director of the National Center for
Health Statistics’’ for ‘‘the Directors’’.
Subsec. (b)(3). Pub. L. 101–239, § 6103(e)(4)(C)(v), substituted ‘‘submitted under section 242k of this title’’ for
‘‘submitted under section 242b, 242c, or 242k of this
title’’ and ‘‘approved under any of such sections’’ for
‘‘approved under section 242b, 242c, or 242k of this
title’’.
Subsec. (d). Pub. L. 101–239, § 6103(e)(4)(D), substituted
‘‘section 242b, 242k, or 242l of this title’’ for ‘‘section
242b, 242c, 242k, 242l, or 242n of this title’’, struck out
‘‘(1)’’ after ‘‘for such other purpose; and’’, and substituted ‘‘publication or release in other form.’’ for
‘‘publication or release in other form, and (2) in the
case of information obtained in the course of health
services research, evaluations, or demonstrations under
section 242b or 242c of this title or in the course of
health care technology activities under section 242n of
this title, such information may not be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person has consented (as determined under
regulations of the Secretary) to its publication or release in other form.’’
Subsec. (e)(1), (2). Pub. L. 101–239, § 6103(e)(4)(E), substituted ‘‘section 242b, 242k, or 242l of this title’’ for
‘‘section 242b, 242c, 242k, 242l, or 242n of this title’’.
Subsec. (f). Pub. L. 101–239, § 6103(e)(4)(F), substituted
‘‘section 242b or 242k of this title’’ for ‘‘section 242b,
242c, 242k, or 242n of this title’’.
Subsec. (g)(1). Pub. L. 101–239, § 6103(e)(4)(G)(i), struck
out at end ‘‘Except as provided in subsection (d) of this
section, the Secretary may not restrict the publication
and dissemination of data from, and results of projects
undertaken by, centers supported under section 242c(d)
of this title.’’
Subsec. (g)(2). Pub. L. 101–239, § 6103(e)(4)(G)(ii), substituted ‘‘sections 242b and 242k of this title’’ for ‘‘sections 242b, 242c, 242k, and 242n of this title’’.
Subsec. (h)(1). Pub. L. 101–239, § 6103(e)(4)(H), substituted ‘‘effectuate the purposes of section 242k of this
title’’ for ‘‘effectuate the purposes of section 242b, 242c,
242k, or 242n of this title’’ and ‘‘contract under any of
such sections’’ for ‘‘contract under section 242b, 242c,
242k, or 242n of this title’’.
Subsec. (i). Pub. L. 101–239, § 6103(e)(4)(I), struck out
subsec. (i) which authorized appropriations for carrying
out certain programs under sections 242b, 242c, 242k,
and 242n of this title during fiscal years 1988 to 1990.
1988—Subsec. (b)(2)(A). Pub. L. 100–690 inserted after
first sentence ‘‘Each application for a grant, contract,
or cooperative agreement in an amount exceeding
$50,000 of direct costs for the dissemination of research
findings or the development of research agendas (in-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

cluding conferences, workshops, and meetings) shall be
submitted to a standing peer review group with persons
with appropriate expertise and shall not be submitted
to any peer review group established to review applications for research, evaluation, or demonstration
projects.’’ and substituted ‘‘an application described in
the first two sentences of this subparagraph’’ for ‘‘each
such application’’ in last sentence.
1987—Subsec. (a)(1), (2). Pub. L. 100–177, § 106(a)(1),
added pars. (1) and (2) and struck out former pars. (1)
and (2) which read as follows:
‘‘(1) Not later than December 1 of each year, the Secretary shall make a report to Congress respecting (A)
the administration of sections 242b, 242c, 242k, and 242l
and section 242n of this title during the preceding fiscal
year, and (B) the current state and progress of health
services research and, health statistics, and health care
technology.
‘‘(2) The Secretary, acting through the National Center for Health Services Research and the National Center for Health Statistics, shall assemble and submit to
the President and the Congress not later than December 1 of each year the following reports:
‘‘(A) A report on health care costs and financing.
Such report shall include a description and analysis
of the statistics collected under section 242k(b)(1)(G)
of this title.
‘‘(B) A report on health resources. Such report shall
include a description and analysis, by geographic
area, of the statistics collected under section
242k(b)(1)(E) of this title.
‘‘(C) A report on the utilization of health resources.
Such report shall include a description and analysis,
by age, sex, income, and geographic area, of the statistics collected under section 242k(b)(1)(F) of this
title.
‘‘(D) A report on the health of the Nation’s people.
Such report shall include a description and analysis,
by age, sex, income, and geographic area, of the statistics collected under section 242k(b)(1)(A) of this
title.’’
Subsec. (a)(3). Pub. L. 100–177, § 106(a)(2), struck out
‘‘or (2)’’ after ‘‘paragraph (1)’’.
Subsec. (b)(1). Pub. L. 100–177, § 107(1), inserted ‘‘and
unless a peer review group referred to in paragraph (2)
has recommended the application for approval’’ before
period at end.
Subsec. (b)(2). Pub. L. 100–177, § 107(2), added par. (2)
and struck out former par. (2) which read as follows:
‘‘Each application submitted for a grant or contract
under section 242b or 242c of this title, in an amount exceeding $50,000 of direct costs and for a health services
research, evaluation, or demonstration project, shall be
submitted by the Secretary for review for scientific
merit to a panel of experts appointed by him from persons who are not officers or employees of the United
States and who possess qualifications relevant to the
project for which the application was made. A panel to
which an application is submitted under this paragraph
shall report its findings and recommendations respecting the application to the Secretary in such form and
manner as the Secretary shall by regulation prescribe.’’
Subsec. (i). Pub. L. 100–177, § 108, amended subsec. (i)
generally, substituting provisions authorizing appropriations for fiscal years 1988 to 1990 for carrying out
activities under sections 242b, 242c, 242k, and 242n of
this title for former provisions authorizing appropriations for fiscal years 1975 to 1987 for carrying out activities under those sections.
1984—Subsec. (i)(1). Pub. L. 98–551, § 7(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and 1987, inserted ‘‘and Health
Care Technology Assessment’’ after ‘‘Research’’, substituted ‘‘and at least 10 per centum of such amount or
$1,500,000, whichever is less, shall be available only for
the user liaison program and the technical assistance
program referred to in section 242c(c)(2) of this title
and for dissemination activities directly undertaken
through such Center’’ for ‘‘and at least 5 per centum of
such amount or $1,000,000, whichever is less, shall be

§ 242m

available only for dissemination activities directly
undertaken through such Center’’, inserted ‘‘For health
care technology assessment activities undertaken
under subsections (b)(5), (e), (f), and (g) of section 242c
of this title the Secretary shall obligate from funds appropriated under this paragraph not less than $3,000,000
for the fiscal year ending September 30, 1985, $3,500,000
for the fiscal year ending September 30, 1986, and
$4,000,000 for the fiscal year ending September 30, 1987.
For grants under section 242n of this title the Secretary shall obligate from funds appropriated under
this paragraph not less than $500,000 for the fiscal year
ending September 30, 1985, $750,000 for the fiscal year
ending September 30, 1986, and $750,000 for the fiscal
year ending September 30, 1987.’’, and in last sentence
substituted ‘‘for any fiscal year’’ for ‘‘for each of the
fiscal years ending September 30, 1982, September 30,
1983, and September 30, 1984,’’.
Subsec. (i)(2). Pub. L. 98–551, § 7(b), inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1985, 1986, and 1987.
1983—Subsec. (d). Pub. L. 97–414 inserted ‘‘, if an establishment or person supplying the information or described in it is identifiable,’’ after ‘‘No information’’,
and substituted ‘‘such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose’’ for ‘‘authorized by guidelines in effect under section 242k(l)(2) of
this title or under regulations of the Secretary’’.
1981—Subsec. (a)(2). Pub. L. 97–35, § 922(a), substituted
‘‘December’’ for ‘‘September’’, which change had already been made by Pub. L. 94–273.
Subsec. (b)(2). Pub. L. 97–35, § 922(b), substituted
‘‘$50,000’’ for ‘‘$35,000’’.
Subsec. (d)(2). Pub. L. 97–35, § 922(c), inserted applicability to health care technology activities under section 242n of this title.
Subsec. (i)(1). Pub. L. 97–35, §§ 917(a), 919(a)(2)(B), inserted provisions respecting amounts of and limitations
on uses for appropriations for the fiscal years ending
Sept. 30, 1982, 1983, and 1984.
Subsec. (i)(2). Pub. L. 97–35, § 917(b), inserted provisions respecting appropriations for the fiscal years ending Sept. 30, 1982, 1983, and 1984.
1978—Subsec. (a)(1). Pub. L. 95–623, § 6(d)(1), required
the report to cover the administration of section 242n
of this title and the current state and progress of
health care technology.
Subsec. (b)(1). Pub. L. 95–623, § 6(d)(2), inserted reference to grant or contract under section 242n of this
title.
Subsec. (d). Pub. L. 95–623, §§ 6(d)(3), 8(b), inserted reference to section 242n of this title and substituted in cl.
(1) ‘‘statistical or epidemiological activities’’ for ‘‘statistical activities’’; and authorized use of information
for purposes other than for which supplied when authorized by guidelines in effect under section 242k(l)(2)
of this title.
Subsecs. (e), (f), (g)(2), (h)(1). Pub. L. 95–623,
§ 6(d)(4)–(7), inserted references to section 242n of this
title.
Subsec. (i)(1). Pub. L. 95–623, § 2(a), authorized appropriation of $35,000,000; $40,000,000; and $45,000,000 for fiscal years ending Sept. 30, 1979, through 1981, and substituted minimum amounts of the lesser of 20 per centum of appropriated funds or $6,000,000 for health services research, evaluation and demonstration activities
of the National Center for Health Services Research
and 5 per centum of such funds or $1,000,000 for dissemination activities of such Center for prior similar requirement of 25 per centum of appropriated funds for
the applicable fiscal years for health services research,
evaluation, and demonstration activities of the Secretary.
Subsec. (i)(2). Pub. L. 95–623, § 2(b), authorized appropriation of $50,000,000; $65,000,000; and $70,000,000 for fiscal years ending Sept. 30, 1979, through 1981.
1977—Subsec. (i)(1). Pub. L. 95–83, § 104(a), authorized
appropriation of $28,600,000 for fiscal year ending Sept.
30, 1978.

§ 242n

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (i)(2). Pub. L. 95–83, § 104(b), authorized appropriation of $33,600,000 for fiscal year ending Sept. 30,
1978.
1976—Subsec. (a). Pub. L. 94–273 substituted ‘‘December’’ for ‘‘September’’ wherever appearing.
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–392, title IV, § 401(e), Nov. 13, 1998, 112
Stat. 3587, provided that: ‘‘This section [amending this
section and sections 247b–5, 247b–6, 247c, 285f–2, 300d–1 to
300d–3, 300d–13, 300d–32, 300k, and 300n–1 of this title] is
deemed to have taken effect immediately after the enactment of Public Law 103–183 [Dec. 14, 1993].’’
EFFECTIVE DATE OF 1988 AMENDMENT
Section 2600 of Pub. L. 100–690 provided that: ‘‘Except
as provided in section 2613(b)(1) [42 U.S.C. 285m note],
the amendments made by this subtitle [subtitle G
(§§ 2600–2641) of title II of Pub. L. 100–690, enacting sections 285m–4 to 285m–6 of this title, amending this section, sections 242c, 281, 284, 284c, 285j, 285m, 285m–1 to
285m–6, 286, 289f, 290cc–28, 290cc–36, 292h, 294a, 295g–4,
295g–7, 295g–8b, 295h, 295h–5, 295j, 297j, 297n, 300cc–3,
300cc–13, 300cc–17, 300cc–20, 300cc–31, 300dd–1, 300dd–3,
300dd–8, 300dd–10, 300dd–12 to 300dd–14, 300dd–21,
300dd–32, 300ee, 300ee–2, 300ee–5, 300ee–12, 300ee–13,
300ee–15 to 300ee–18, 300ee–20, 300ee–22, 300ee–34, 300ff–48,
and 300aaa to 300aaa–13 of this title, and section 393 of
Title 21, Food and Drugs, enacting provisions set out as
notes under section 285m of this title, amending provisions set out as notes under sections 201, 292h, 300cc,
300ee–1, and 300ff–48 of this title, and repealing provisions set out as a note under section 285m of this title]
shall take effect immediately after the enactment of
the Health Omnibus Programs Extension of 1988 [Nov.
4, 1988].’’
EFFECTIVE DATE OF 1987 AMENDMENT
Section 106(c) of Pub. L. 100–177 provided that: ‘‘The
amendments made by subsections (a) and (b) [amending
this section and section 242p of this title] shall apply to
reports and profiles required to be submitted after November 1, 1987.’’
MINE WORKERS STUDY; REPORT COMPLETED AND SUBMITTED NO LATER THAN 30 MONTHS AFTER NOVEMBER 9, 1978
Section 10 of Pub. L. 95–623, as amended by S. Res. 30,
Mar. 7, 1979; H. Res. 549, Mar. 25, 1980, required the Secretary, acting through the National Center for Health
Services Research, to arrange for the conduct of a
study to evaluate the impact upon the utilization of
health services by and the health status of members of
the United Mine Workers and their dependents as a result of changes in the United Mine Workers’ collectivebargaining agreements of Mar. 1978 with a report to be
submitted to the Secretary and specific committees of
the Senate and House of Representatives within 30
months after Nov. 9, 1978.
AUTHORIZATION OF APPROPRIATIONS FOR FISCAL YEAR
ENDING JUNE 30, 1977
Section 107(b) of Pub. L. 93–353 provided that: ‘‘The
authorizations of appropriations provided by section
308(i) of the Public Health Service Act [subsec. (i) of
this section] is extended for the fiscal year ending June
30, 1977, in the amounts authorized for the preceding
fiscal year unless before June 30, 1976, Congress has
passed legislation repealing this subsection.’’

§ 242n. Repealed. Pub. L. 101–239, title VI,
§ 6103(d)(1)(B), Dec. 19, 1989, 103 Stat. 2205
Section, act July 1, 1944, ch. 373, title III, § 309, as
added Nov. 9, 1978, Pub. L. 95–623, § 6(c), 92 Stat. 3447;
amended July 10, 1979, Pub. L. 96–32, § 5(d), 93 Stat. 83;
Aug. 13, 1981, Pub. L. 97–35, title IX, §§ 917(c), 923, 95
Stat. 565, 567; Oct. 30, 1984, Pub. L. 98–551, § 8, 98 Stat.
2820; Oct. 7, 1985, Pub. L. 99–117, § 8(a), 99 Stat. 493; Dec.

Page 138

1, 1987, Pub. L. 100–177, title I, § 109, 101 Stat. 990, related
to grants for a council on health care technology.
TERMINATION OF COUNCIL ON HEALTH CARE
TECHNOLOGY
Section 6103(d)(1)(B) of Pub. L. 101–239 provided in
part that the council on health care technology established under this section is terminated.
TRANSITIONAL AND SAVINGS PROVISIONS FOR
PUB. L. 101–239
For provision transferring personnel of Department
of Health and Human Services employed on Dec. 19,
1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to
amendments made by section 6103 of Pub. L. 101–239,
and assets, liabilities, etc., of Department arising from
or employed, held, used, or available on that date, or to
be made available after that date, in connection with
those functions, to Administrator for appropriate allocation, and for provisions for continued effectiveness of
actions, orders, rules, official documents, etc., of Department that have been issued, made, granted, or allowed to become effective in performance of those functions, and that were effective on Dec. 19, 1989, see section 6103(f) of Pub. L. 101–239, set out as a note under
section 299 of this title.

§ 242o. Health conferences; publication of health
educational information
(a) A conference of the health authorities in
and among the several States shall be called annually by the Secretary. Whenever in his opinion the interests of the public health would be
promoted by a conference, the Secretary may
invite as many of such health authorities and
officials of other State or local public or private
agencies, institutions, or organizations to confer
as he deems necessary or proper. Upon the application of health authorities of five or more
States it shall be the duty of the Secretary to
call a conference of all State health authorities
joining in the request. Each State represented
at any conference shall be entitled to a single
vote. Whenever at any such conference matters
relating to mental health are to be discussed,
the mental health authorities of the respective
States shall be invited to attend.
(b) From time to time the Secretary shall
issue information related to public health, in
the form of publications or otherwise, for the
use of the public, and shall publish weekly reports of health conditions in the United States
and other countries and other pertinent health
information for the use of persons and institutions concerned with health services.
(July 1, 1944, ch. 373, title III, § 310, formerly
§§ 309, 310, as added Pub. L. 93–353, title I, § 107(a),
July 23, 1974, 88 Stat. 371; renumbered § 310, Pub.
L. 95–623, § 6(a), (b), Nov. 9, 1978, 92 Stat. 3447.)
CODIFICATION
Subsec. (a) of this section consists of former section
309 of act July 1, 1944, prior to the renumbering of that
section as section 310(a) by Pub. L. 95–623. Subsec. (b) of
this section consists of former section 310 of act July 1,
1944, prior to the renumbering of that section as section
310(b) by Pub. L. 95–623.
PRIOR PROVISIONS
A prior section 310 of act July 1, 1944, was renumbered
section 329, and was classified to section 254b of this
title prior to the general amendment of subpart I (§ 254b
et seq.) of part D of this subchapter by Pub. L. 104–299.

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Provisions similar to those comprising subsec. (a) of
this section were contained in section 312 of act July 1,
1944, ch. 373, title III, 58 Stat. 693, as amended (formerly
classified to section 244 of this title), prior to repeal by
Pub. L. 93–353, § 102(a).
Provisions similar to those comprising subsec. (b) of
this section were contained in section 315 of act July 1,
1944, ch. 373, title III, 58 Stat. 695; Oct. 30, 1970, Pub. L.
91–515, title II, § 282, 84 Stat. 1308 (formerly classified to
section 247 of this title), prior to repeal by Pub. L.
93–353, § 102(a).

§ 242p. National disease prevention data profile
(a) The Secretary, acting through the National Center for Health Statistics, shall submit
to Congress on March 15, 1990, and on March 15
of every third year thereafter, a national disease
prevention data profile in order to provide a
data base for the effective implementation of
this Act and to increase public awareness of the
prevalence, incidence, and any trends in the preventable causes of death and disability in the
United States. Such profile shall include at a
minimum—
(1) mortality rates for preventable diseases;
(2) morbidity rates associated with preventable diseases;
(3) the physical determinants of health of
the population of the United States and the relationship between these determinants of
health and the incidence and prevalence of
preventable causes of death and disability; and
(4) the behavioral determinants of health of
the population of the United States including,
but not limited to, smoking, nutritional and
dietary habits, exercise, and alcohol consumption, and the relationship between these determinants of health and the incidence and prevalence of preventable causes of death and disability.
(b) In preparing the profile required by subsection (a) of this section, the Secretary, acting
through the National Center for Health Statistics, shall comply with all relevant provisions of
sections 242k and 242m of this title.
(Pub. L. 95–626, title IV, § 404, Nov. 10, 1978, 92
Stat. 3591; Pub. L. 100–177, title I, § 106(b), Dec. 1,
1987, 101 Stat. 989.)
REFERENCES IN TEXT
This Act, referred to in subsec. (a), is Pub. L. 95–626,
Nov. 10, 1978, 92 Stat. 3551, known as the Health Services and Centers Amendments of 1978. For complete
classification of this Act to the Code, see Short Title of
1978 Amendments note set out under section 201 of this
title and Tables.
CODIFICATION
Section was enacted as part of the Health Services
and Centers Amendments of 1978, and not as part of the
Public Health Service Act which comprises this chapter.
AMENDMENTS
1987—Subsec. (a). Pub. L. 100–177 substituted ‘‘on
March 15, 1990, and on March 15 of every third year
thereafter’’ for ‘‘on December 1, 1980, and on December
1 of every third year thereafter’’ in first sentence.
EFFECTIVE DATE OF 1987 AMENDMENT
Amendment by Pub. L. 100–177 applicable to reports
and profiles required to be submitted after Nov. 1, 1987,
see section 106(c) of Pub. L. 100–177, set out as a note
under section 242m of this title.

§ 242q–1

§ 242q. Task Force on Aging Research; establishment and duties
(a) Establishment
The Secretary of Health and Human Services
shall establish a Task Force on Aging Research.
(b) Duties
With respect to aging research (as defined in
section 242q–4 1 of this title), the Task Force
each fiscal year shall—
(1) make recommendations to the Secretary
specifying the particular projects of research,
or the particular categories of research, that
should be conducted or supported by the Secretary;
(2) of the projects specified under paragraph
(1), make recommendations to the Secretary
of the projects that should be given priority in
the provision of funds; and
(3) make recommendations to the Secretary
of the amount of funds that should be appropriated for such research.
(c) Provision of information to public
The Task Force may make available to health
professionals, and to other members of the public, information regarding the research described in subsection (b) of this section.
(Pub. L. 101–557, title III, § 301, Nov. 15, 1990, 104
Stat. 2768.)
REFERENCES IN TEXT
Section 242q–4 of this title, referred to in subsec. (b),
was in the original ‘‘section 305’’, meaning section 305
of Pub. L. 101–557. Section 305 was renumbered section
304 by Pub. L. 109–482, title I, § 104(b)(3)(B), Jan. 15, 2007,
120 Stat. 3694.
CODIFICATION
Section was enacted as part of the Home Health Care
and Alzheimer’s Disease Amendments of 1990, and not
as part of the Public Health Service Act which comprises this chapter.

§ 242q–1. Membership
(a) Composition
The Task Force shall be composed of—
(1) the Assistant Secretary for Health;
(2) the Surgeon General of the Public Health
Service;
(3) the Assistant Secretary for Planning and
Evaluation;
(4) the Director of the National Institute on
Aging, and the Directors of such other agencies of the National Institutes of Health as the
Secretary determines to be appropriate;
(5) the Commissioner of the Administration
on Aging;
(6) the Commissioner of Food and Drugs;
(7) the Under Secretary for Health of the Department of Veterans Affairs;
(8) the Administrator of the the 1 Substance
Abuse and Mental Health Services Administration;
(9) the Administrator of the Centers for
Medicare & Medicaid Services;
(10) the Commissioner of Social Security;
(11) the Director of the Agency for Healthcare Research and Quality;
1 See
1 So

References in Text note below.
in original.

§ 242q–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(12) two Members of the House of Representatives appointed by the Speaker of the House
in consultation with the Minority Leader, and
two members of the Senate appointed by the
Majority Leader in consultation with the Minority Leader, not more than one of whom
from each body shall be members of the same
political party; and
(13) three members of the general public, to
be appointed by the Secretary, that shall include one representative each from—
(A) a nonprofit group representing older
Americans;
(B) a private voluntary health organization concerned with the health problems affecting older Americans; and
(C) a nonprofit organization concerned
with research related to the health and independence of older Americans.
(b) Chair
The Secretary, acting through either the Assistant Secretary for Health or the Director of
the National Institute on Aging, shall serve as
the Chair of the Task Force.
(c) Quorum
A majority of the members of the Task Force
shall constitute a quorum, and a lesser number
may hold hearings.
(d) Meetings
The Task Force shall meet periodically at the
call of the Chair, but in no event less than twice
each year.
(e) Compensation and expenses
(1) Compensation
Members of the Task Force who are not regular full-time employees of the United States
Government shall, while attending meetings
and conferences of the Task Force or otherwise engaged in the business of the Task Force
(including traveltime), be entitled to receive
compensation at a rate fixed by the Secretary,
but not exceeding the rate specified at the
time of such service under GS–18 of the General Schedules established under section 5332
of title 5.
(2) Expenses
While away from their homes or regular
places of business on the business of the Task
Force, members of such Task Force may be allowed travel expenses, including per diem in
lieu of subsistence, as is authorized under section 5703 of title 5 for persons employed intermittently in the Government service.
(Pub. L. 101–557, title III, § 302, Nov. 15, 1990, 104
Stat. 2769; Pub. L. 102–321, title I, § 161, July 10,
1992, 106 Stat. 375; Pub. L. 102–405, title III,
§ 302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L.
106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670; Pub.
L. 108–173, title IX, § 900(e)(6)(D), Dec. 8, 2003, 117
Stat. 2373.)
CODIFICATION
Section was enacted as part of the Home Health Care
and Alzheimer’s Disease Amendments of 1990, and not
as part of the Public Health Service Act which comprises this chapter.

Page 140

AMENDMENTS
2003—Subsec. (a)(9). Pub. L. 108–173 substituted ‘‘Centers for Medicare & Medicaid Services’’ for ‘‘Health
Care Financing Administration’’.
1999—Subsec. (a)(11). Pub. L. 106–129 substituted ‘‘Director of the Agency for Healthcare Research and Quality’’ for ‘‘Administrator for Health Care Policy and Research’’.
1992—Subsec. (a)(7). Pub. L. 102–405 substituted
‘‘Under Secretary for Health of the Department of Veterans Affairs’’ for ‘‘Chief Medical Director of the Department of Veterans Affairs’’.
Subsec. (a)(8). Pub. L. 102–321 substituted ‘‘Substance
Abuse and Mental Health Services Administration’’ for
‘‘Alcohol, Drug Abuse and Mental Health Administration’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 242q–2. Administrative staff and support
The Secretary, acting through either the Assistant Secretary for Health or the Director of
the National Institute on Aging, shall appoint
an Executive Secretary for the Task Force and
shall provide the Task Force with such administrative staff and support as may be necessary to
enable the Task Force to carry out subsections
(b) and (c) of section 242q of this title.
(Pub. L. 101–557, title III, § 303, Nov. 15, 1990, 104
Stat. 2770.)
CODIFICATION
Section was enacted as part of the Home Health Care
and Alzheimer’s Disease Amendments of 1990, and not
as part of the Public Health Service Act which comprises this chapter.

§ 242q–3. Repealed. Pub. L. 109–482, title I,
§ 104(b)(3)(B), Jan. 15, 2007, 120 Stat. 3694
Section, Pub. L. 101–557, title III, § 304, Nov. 15, 1990,
104 Stat. 2770, related to reports that provided recommendations required in section 242q(b) of this title.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 242q–4. Definitions
For purposes of sections 242q to 242q–5 of this
title:
(1) Aging research
(A) The term ‘‘aging research’’ means research on the aging process and on the diagnosis and treatment of diseases, disorders, and
complications related to aging, including
menopause. Such research includes research

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on such treatments, and on medical devices
and other medical interventions regarding
such diseases, disorders, and complications,
that can assist individuals in avoiding institutionalization and prolonged hospitalization
and in otherwise increasing the independence
of the individuals.
(B) For purposes of subparagraph (A), the
term ‘‘independence’’, with respect to diseases,
disorders, and complications of aging, means
the functional ability of individuals to perform activities of daily living or instrumental
activities of daily living without assistance or
supervision.
(2) Secretary
The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(3) Task Force
The term ‘‘Task Force’’ means the Task
Force on Aging Research established under
section 242q(a) of this title.
(Pub. L. 101–557, title III, § 304, formerly § 305,
Nov. 15, 1990, 104 Stat. 2770; renumbered § 304,
Pub. L. 109–482, title I, § 104(b)(3)(B), Jan. 15, 2007,
120 Stat. 3694.)
CODIFICATION
Section was enacted as part of the Home Health Care
and Alzheimer’s Disease Amendments of 1990, and not
as part of the Public Health Service Act which comprises this chapter.
PRIOR PROVISIONS
A prior section 304 of Pub. L. 101–557 was classified to
section 242q–3 of this title, prior to repeal by Pub. L.
109–482.

§ 242q–5. Authorization of appropriations
For the purpose of carrying out sections 242q
to 242q–5 of this title, there are authorized to be
appropriated such sums as may be necessary for
each of the fiscal years 1991 through 1993.
(Pub. L. 101–557, title III, § 305, formerly § 306,
Nov. 15, 1990, 104 Stat. 2770; renumbered § 305,
Pub. L. 109–482, title I, § 104(b)(3)(B), Jan. 15, 2007,
120 Stat. 3694.)
CODIFICATION
Section was enacted as part of the Home Health Care
and Alzheimer’s Disease Amendments of 1990, and not
as part of the Public Health Service Act which comprises this chapter.
PRIOR PROVISIONS
A prior section 305 of Pub. L. 101–557 was renumbered
section 304 and is classified to section 242q–4 of this
title.

§ 242r. Improvement and publication of data on
food-related allergic responses
(a) In general
The Secretary of Health and Human Services,
acting through the Director of the Centers for
Disease Control and Prevention and in consultation with the Commissioner of Food and Drugs,
shall improve (including by educating physicians and other health care providers) the collection of, and publish as it becomes available,
national data on—

§ 242s

(1) the prevalence of food allergies;
(2) the incidence of clinically significant or
serious adverse events related to food allergies; and
(3) the use of different modes of treatment
for and prevention of allergic responses to
foods.
(b) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary.
(Pub. L. 108–282, title II, § 207, Aug. 2, 2004, 118
Stat. 910.)
CODIFICATION
Section was enacted as part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as
part of the Public Health Service Act which comprises
this chapter.

§ 242s. Centers for Disease Control and Prevention Office of Women’s Health
(a) Establishment
There is established within the Office of the
Director of the Centers for Disease Control and
Prevention, an office to be known as the Office
of Women’s Health (referred to in this section as
the ‘‘Office’’). The Office shall be headed by a director who shall be appointed by the Director of
such Centers.
(b) Purpose
The Director of the Office shall—
(1) report to the Director of the Centers for
Disease Control and Prevention on the current
level of the Centers’ activity regarding women’s health conditions across, where appropriate, age, biological, and sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and professional education, services, and treatment;
(2) establish short-range and long-range
goals and objectives within the Centers for
women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Centers that relate to prevention, research, education and
training, service delivery, and policy development, for issues of particular concern to
women;
(3) identify projects in women’s health that
should be conducted or supported by the Centers;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and
other individuals and groups, as appropriate,
on the policy of the Centers with regard to
women; and
(5) serve as a member of the Department of
Health and Human Services Coordinating
Committee on Women’s Health (established
under section 237a(b)(4) of this title).
(c) Definition
As used in this section, the term ‘‘women’s
health conditions’’, with respect to women of all
age, ethnic, and racial groups, means diseases,
disorders, and conditions—
(1) unique to, significantly more serious for,
or significantly more prevalent in women; and

§ 243

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) for which the factors of medical risk or
type of medical intervention are different for
women, or for which there is reasonable evidence that indicates that such factors or types
may be different for women.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 310A, as added
Pub. L. 111–148, title III, § 3509(b), Mar. 23, 2010,
124 Stat. 533.)
PRIOR PROVISIONS
A prior section 310A of act July 1, 1944, was renumbered section 226 and transferred to section 235 of this
title.

PART B—FEDERAL-STATE COOPERATION
§ 243. General grant of authority for cooperation
(a) Enforcement of quarantine regulations; prevention of communicable diseases
The Secretary is authorized to accept from
State and local authorities any assistance in the
enforcement of quarantine regulations made
pursuant to this chapter which such authorities
may be able and willing to provide. The Secretary shall also assist States and their political
subdivisions in the prevention and suppression
of communicable diseases and with respect to
other public health matters, shall cooperate
with and aid State and local authorities in the
enforcement of their quarantine and other
health regulations, and shall advise the several
States on matters relating to the preservation
and improvement of the public health.
(b) Comprehensive and continuing planning;
training of personnel for State and local
health work; fees
The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their
current and future health needs, the establishment and maintenance of adequate public health
services, and otherwise carrying out public
health activities. The Secretary is also authorized to train personnel for State and local
health work. The Secretary may charge only
private entities reasonable fees for the training
of their personnel under the preceding sentence.
(c) Development of plan to control epidemics and
meet emergencies or problems resulting from
disasters; cooperative planning; temporary
assistance; reimbursement of United States
(1) The Secretary is authorized to develop (and
may take such action as may be necessary to
implement) a plan under which personnel, equipment, medical supplies, and other resources of
the Service and other agencies under the jurisdiction of the Secretary may be effectively used
to control epidemics of any disease or condition
and to meet other health emergencies or problems. The Secretary may enter into agreements
providing for the cooperative planning between
the Service and public and private community
health programs and agencies to cope with

Page 142

health problems (including epidemics and health
emergencies).
(2) The Secretary may, at the request of the
appropriate State or local authority, extend
temporary (not in excess of six months) assistance to States or localities in meeting health
emergencies of such a nature as to warrant Federal assistance. The Secretary may require such
reimbursement of the United States for assistance provided under this paragraph as he may
determine to be reasonable under the circumstances. Any reimbursement so paid shall be
credited to the applicable appropriation for the
Service for the year in which such reimbursement is received.
(July 1, 1944, ch. 373, title III, § 311, 58 Stat. 693;
Pub. L. 89–749, § 5, Nov. 3, 1966, 80 Stat. 1190; Pub.
L. 90–174, § 4, Dec. 5, 1967, 81 Stat. 536; Pub. L.
91–515, title II, § 282, Oct. 30, 1970, 84 Stat. 1308;
Pub. L. 94–317, title II, § 202(b), (c), June 23, 1976,
90 Stat. 703; Pub. L. 97–35, title IX, § 902(c), Aug.
13, 1981, 95 Stat. 559; Pub. L. 97–414, § 8(d), Jan. 4,
1983, 96 Stat. 2060; Pub. L. 99–117, § 11(a), Oct. 7,
1985, 99 Stat. 494.)
AMENDMENTS
1985—Subsec. (c)(1). Pub. L. 99–117 struck out ‘‘referred to in section 247b(f) of this title’’ after ‘‘epidemics of any disease or condition’’, ‘‘involving or resulting
from disasters or any such disease’’ after ‘‘health emergencies or problems’’ in first sentence, and struck out
‘‘resulting from disasters or any disease or condition
referred to in section 247b(f) of this title’’ after ‘‘(including epidemics and health emergencies)’’ in second
sentence.
1983—Subsec. (c)(2). Pub. L. 97–414 substituted ‘‘six
months’’ for ‘‘forty-five days’’ after ‘‘not in excess of’’.
1981—Subsec. (a). Pub. L. 97–35, § 902(c)(1), inserted applicability to other public health matters, and struck
out reference to section 246 of this title.
Subsec. (b). Pub. L. 97–35, § 902(c)(2), substituted ‘‘public health activities’’ for ‘‘the purposes of section 246 of
this title’’.
1976—Subsec. (b). Pub. L. 94–317, § 202(c), inserted provision authorizing Secretary to charge only private entities reasonable fees for training of their personnel.
Subsec. (c). Pub. L. 94–317, § 202(b), made changes in
phraseology and restructured provisions into pars. (1)
and (2) and, in par. (1), as so restructured, inserted provisions authorizing Secretary to develop a plan utilizing Public Health Service personnel, equipment, medical supplies and other resources to control epidemics of
any disease referred to in section 247b of this title.
1970—Subsecs. (a), (b). Pub. L. 91–515 substituted
‘‘Secretary’’ for ‘‘Surgeon General’’ wherever appearing.
1967—Subsec. (c). Pub. L. 90–174 added subsec. (c).
1966—Pub. L. 89–749 designated existing provisions as
subsec. (a), added subsec. (b), and amended subsec. (b)
to permit Surgeon General to train personnel for State
and local health work.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see
section 902(h) of Pub. L. 97–35, set out as a note under
section 238l of this title.
EFFECTIVE DATE OF 1966 AMENDMENT
Section 5(a) of Pub. L. 89–749 provided that subsec. (b)
of this section is effective July 1, 1966.
Section 5(b) of Pub. L. 89–749 provided that the
amendment of subsec. (b) of this section, permitting
the Surgeon General to train personnel for State and
local health work, is effective July 1, 1967.
FOOD ALLERGENS IN THE FOOD CODE
Pub. L. 108–282, title II, § 209, Aug. 2, 2004, 118 Stat.
910, provided that: ‘‘The Secretary of Health and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Human Services shall, in the Conference for Food Protection, as part of its efforts to encourage cooperative
activities between the States under section 311 of the
Public Health Service Act (42 U.S.C. 243), pursue revision of the Food Code to provide guidelines for preparing allergen-free foods in food establishments, including in restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias.
The Secretary shall consider guidelines and recommendations developed by public and private entities for
public and private food establishments for preparing allergen-free foods in pursuing this revision.’’
TRAINING OF PRIVATE PERSONS SUBJECT TO
REIMBURSEMENT OR ADVANCES TO APPROPRIATIONS
Pub. L. 103–333, title II, Sept. 30, 1994, 108 Stat. 2550,
provided in part: ‘‘That for fiscal year 1995 and subsequent fiscal years training of private persons shall be
made subject to reimbursement or advances to this appropriation for not in excess of the full cost of such
training’’.

§ 244. Public access defibrillation programs
(a) In general
The Secretary shall award grants to States,
political subdivisions of States, Indian tribes,
and tribal organizations to develop and implement public access defibrillation programs—
(1) by training and equipping local emergency medical services personnel, including
firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary resuscitation and
automated external defibrillation, to cardiac
arrest victims;
(2) by purchasing automated external defibrillators, placing the defibrillators in public
places where cardiac arrests are likely to
occur, and training personnel in such places to
administer cardiopulmonary resuscitation and
automated external defibrillation to cardiac
arrest victims;
(3) by setting procedures for proper maintenance and testing of such devices, according to
the guidelines of the manufacturers of the devices;
(4) by providing training to members of the
public in cardiopulmonary resuscitation and
automated external defibrillation;
(5) by integrating the emergency medical
services system with the public access
defibrillation programs so that emergency
medical services personnel, including dispatchers, are informed about the location of
automated external defibrillators in their
community; and
(6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide
training for their employees to administer
cardiopulmonary resuscitation and external
automated defibrillation to cardiac arrest victims in their community.
(b) Preference
In awarding grants under subsection (a) of this
section, the Secretary shall give a preference to
a State, political subdivision of a State, Indian
tribe, or tribal organization that—
(1) has a particularly low local survival rate
for cardiac arrests, or a particularly low local
response rate for cardiac arrest victims; or

§ 244

(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access defibrillation program.
(c) Use of funds
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a
grant under subsection (a) of this section may
use funds received through such grant to—
(1) purchase automated external defibrillators that have been approved, or cleared for
marketing, by the Food and Drug Administration;
(2) provide automated external defibrillation
and basic life support training in automated
external defibrillator usage through nationally recognized courses;
(3) provide information to community members about the public access defibrillation program to be funded with the grant;
(4) provide information to the local emergency medical services system regarding the
placement of automated external defibrillators in public places;
(5) produce materials to encourage private
companies, including small businesses, to purchase automated external defibrillators;
(6) establish an information clearinghouse,
that shall be administered by an organization
that has substantial expertise in pediatric
education,
pediatric
medicine,
and
electrophysiology and sudden death, that provides information to increase public access to
defibrillation in schools; and
(7) further develop strategies to improve access to automated external defibrillators in
public places.
(d) Application
(1) In general
To be eligible to receive a grant under subsection (a) of this section, a State, political
subdivision of a State, Indian tribe, or tribal
organization shall prepare and submit an application to the Secretary at such time, in
such manner, and containing such information
as the Secretary may reasonably require.
(2) Contents
An application submitted under paragraph
(1) shall—
(A) describe the comprehensive public access defibrillation program to be funded with
the grant and demonstrate how such program would make automated external
defibrillation accessible and available to
cardiac arrest victims in the community;
(B) contain procedures for implementing
appropriate nationally recognized training
courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators;
(C) contain procedures for ensuring direct
involvement of a licensed medical professional and coordination with the local emergency medical services system in the oversight of training and notification of incidents of the use of the automated external
defibrillators;
(D) contain procedures for proper maintenance and testing of the automated external
defibrillators, according to the labeling of
the manufacturer;

§ 244–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(E) contain procedures for ensuring notification of local emergency medical services
system personnel, including dispatchers, of
the location and type of devices used in the
public access defibrillation program; and
(F) provide for the collection of data regarding the effectiveness of the public access
defibrillation program to be funded with the
grant in affecting the out-of-hospital cardiac
arrest survival rate.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$25,000,000 for for 1 each of fiscal years 2003
through 2014. Not more than 10 percent of
amounts received under a grant awarded under
this section may be used for administrative expenses.
(July 1, 1944, ch. 373, title III, § 312, as added Pub.
L. 107–188, title I, § 159(c), June 12, 2002, 116 Stat.
634; amended Pub. L. 108–41, § 2, July 1, 2003, 117
Stat. 839; Pub. L. 111–148, title X, § 10412, Mar. 23,
2010, 124 Stat. 990.)
PRIOR PROVISIONS
A prior section 244, acts July 1, 1944, ch. 373, title III,
§ 312, 58 Stat. 693; July 3, 1946, ch. 538, § 8, 60 Stat. 424;
Dec. 5, 1967, Pub. L. 90–174, § 12(b), 81 Stat. 541; Oct. 30,
1970, Pub. L. 91–515, title II, § 282, 84 Stat. 1308, provided
for health conferences, prior to repeal by Pub. L. 93–353,
title I, § 102(a), July 23, 1974, 88 Stat. 362. See section
242o(a) of this title.
A prior section 312 of act July 1, 1944, was classified
to section 244–1 of this title prior to repeal by Pub. L.
94–484.
AMENDMENTS
2010—Subsec. (c)(6). Pub. L. 111–148, § 10412(1), inserted
‘‘, that shall be administered by an organization that
has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden
death,’’ after ‘‘clearinghouse’’.
Subsec. (e). Pub. L. 111–148, § 10412(2), substituted ‘‘for
each of fiscal years 2003 through 2014’’ for ‘‘fiscal year
2003, and such sums as may be necessary for each of the
fiscal years 2004 through 2006’’.
2003—Subsec. (c)(6), (7). Pub. L. 108–41 added par. (6)
and redesignated former par. (6) as (7).
FINDINGS
Pub. L. 107–188, title I, § 159(b), June 12, 2002, 116 Stat.
634, provided that: ‘‘Congress makes the following findings:
‘‘(1) Over 220,000 Americans die each year from cardiac arrest. Every 2 minutes, an individual goes into
cardiac arrest in the United States.
‘‘(2) The chance of successfully returning to a normal heart rhythm diminishes by 10 percent each
minute following sudden cardiac arrest.
‘‘(3) Eighty percent of cardiac arrests are caused by
ventricular fibrillation, for which defibrillation is the
only effective treatment.
‘‘(4) Sixty percent of all cardiac arrests occur outside the hospital. The average national survival rate
for out-of-hospital cardiac arrest is only 5 percent.
‘‘(5) Communities that have established and implemented public access defibrillation programs have
achieved average survival rates for out-of-hospital
cardiac arrest as high as 50 percent.
‘‘(6) According to the American Heart Association,
wide use of defibrillators could save as many as 50,000
lives nationally each year.
‘‘(7) Successful public access defibrillation programs ensure that cardiac arrest victims have access
1 So

in original.

Page 144

to early 911 notification, early cardiopulmonary resuscitation, early defibrillation, and early advanced
care.’’

§ 244–1. Repealed. Pub. L. 94–484, title V, § 503(b),
Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, § 312, formerly § 306, as added Aug. 2, 1956, ch. 871, title I, § 101,
70 Stat. 923; amended July 23, 1959, Pub. L. 86–105, § 1, 73
Stat. 239; Sept 8, 1960, Pub. L. 86–720, § 1(b), 74 Stat. 820;
Aug. 27, 1964, Pub. L. 88–497, § 2, 78 Stat. 613; Aug. 16,
1968, Pub. L. 90–490, title III, § 302(b), 82 Stat. 789; Mar.
12, 1970, Pub. L. 91–208, § 3, 84 Stat. 52; Oct. 30, 1970, Pub.
L. 91–515, title VI, § 601(b)(2), 84 Stat. 1311; June 18, 1973,
Pub. L. 93–45, title I, § 104(a), 87 Stat. 91; renumbered
§ 312 and amended July 23, 1974, Pub. L. 93–353, title I,
§ 102(b), 88 Stat. 362; Oct. 12, 1976, Pub. L. 94–484, title I,
§ 101(a)(1), 90 Stat. 2244, related to graduate or specialized training for physicians, engineers, nurses, and
other professional personnel.
EFFECTIVE DATE OF REPEAL
Section 503(c) of Pub. L. 94–484 provided that: ‘‘The
amendments made by this section [amending former
section 295f–2 of this title and repealing this section
and section 245a of this title] shall take effect October
1, 1977.’’

§ 244a. Repealed. Pub. L. 93–353, title I, § 102(a),
July 23, 1974, 88 Stat. 362
Section, act July 1, 1944, ch. 373, title III, § 312a, as
added Aug. 31, 1954, ch. 1158, § 2, 68 Stat. 1025, related to
birth and death statistics, annual collection, and compensation for transcription. See section 242k(h) of this
title.

§ 245. Public access defibrillation demonstration
projects
(a) In general
The Secretary shall award grants to political
subdivisions of States, Indian tribes, and tribal
organizations to develop and implement innovative, comprehensive, community-based public
access defibrillation demonstration projects
that—
(1) provide cardiopulmonary resuscitation
and automated external defibrillation to cardiac arrest victims in unique settings;
(2) provide training to community members
in cardiopulmonary resuscitation and automated external defibrillation; and
(3) maximize community access to automated external defibrillators.
(b) Use of funds
A recipient of a grant under subsection (a) of
this section shall use the funds provided through
the grant to—
(1) purchase automated external defibrillators that have been approved, or cleared for
marketing, by the Food and Drug Administration;
(2) provide basic life training in automated
external defibrillator usage through nationally recognized courses;
(3) provide information to community members about the public access defibrillation
demonstration project to be funded with the
grant;
(4) provide information to the local emergency medical services system regarding the
placement of automated external defibrillators in the unique settings; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) further develop strategies to improve access to automated external defibrillators in
public places.
(c) Application
(1) In general
To be eligible to receive a grant under subsection (a) of this section, a political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application
to the Secretary at such time, in such manner,
and containing such information as the Secretary may reasonably require.
(2) Contents
An application submitted under paragraph
(1) may—
(A) describe the innovative, comprehensive,
community-based
public
access
defibrillation demonstration project to be
funded with the grant;
(B) explain how such public access
defibrillation demonstration project represents innovation in providing public access
to automated external defibrillation; and
(C) provide for the collection of data regarding the effectiveness of the demonstration project to be funded with the grant in—
(i)
providing
emergency
cardiopulmonary resuscitation and automated
external defibrillation to cardiac arrest
victims in the setting served by the demonstration project; and
(ii) affecting the cardiac arrest survival
rate in the setting served by the demonstration project.
(d) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $5,000,000 for each of fiscal
years 2002 through 2006. Not more than 10 percent of amounts received under a grant awarded
under this section may be used for administrative expenses.
(July 1, 1944, ch. 373, title III, § 313, as added Pub.
L. 107–188, title I, § 159(c), June 12, 2002, 116 Stat.
636.)
PRIOR PROVISIONS
A prior section 245, acts July 1, 1944, ch. 373, title III,
§ 313, 58 Stat. 693; Oct. 30, 1970, Pub. L. 91–515, title II,
§ 282, 84 Stat. 1308, provided for collection of vital statistics, prior to repeal by Pub. L. 93–353, title I, § 102(a),
July 23, 1974, 88 Stat. 362. See section 242k(g) of this
title.
A prior section 313 of act July 1, 1944, was classified
to section 245a of this title prior to repeal by Pub. L.
94–484.

§ 245a. Repealed. Pub. L. 94–484, title V, § 503(b),
Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, § 313, formerly § 309, as added Sept. 8, 1960, Pub. L. 86–720, § 1(a),
74 Stat. 819; amended Aug. 27, 1964, Pub. L. 88–497, § 3, 78
Stat. 613; Nov. 3, 1966, Pub. L. 89–749, § 4, 80 Stat. 1190;
Dec. 5, 1967, Pub. L. 90–174, §§ 2(g), 8(c), 81 Stat. 534, 540;
Aug. 16, 1968, Pub. L. 90–490, title III, § 302(a), 82 Stat.
788; Mar. 12, 1970, Pub. L. 91–208, §§ 1, 2, 84 Stat. 52; June
30, 1970, Pub. L. 91–296, title IV, § 401(b)(1)(B), 84 Stat.
352; June 18, 1973, Pub. L. 93–45, title I, § 104(b), (c), 87
Stat. 91; renumbered § 313 and amended July 23, 1974,
Pub. L. 93–353, title I, § 102(c), 88 Stat. 362; Oct. 12, 1976,
Pub. L. 94–484, title I, § 101(a)(2), (3), 90 Stat. 2244, related to graduate public health training grants.

§ 246

EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1977, see section 503(c) of Pub.
L. 94–484, set out as a note under section 244–1 of this
title.

§ 246. Grants and services to States
(a) Comprehensive health planning and services
(1) In order to assist the States in comprehensive and continuing planning for their current
and future health needs, the Secretary is authorized during the period beginning July 1,
1966, and ending June 30, 1973, to make grants to
States which have submitted, and had approved
by the Secretary, State plans for comprehensive
State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the
fiscal year ending June 30, 1968, $10,000,000 for
the fiscal year ending June 30, 1969, $15,000,000
for the fiscal year ending June 30, 1970,
$15,000,000 for the fiscal year ending June 30,
1971, $17,000,000 for the fiscal year ending June
30, 1972, $20,000,000 for the fiscal year ending
June 30, 1973, and $10,000,000 for the fiscal year
ending June 30, 1974.
(2) In order to be approved for purposes of this
subsection, a State plan for comprehensive
State health planning must—
(A) designate, or provide for the establishment of, a single State agency, which may be
an interdepartmental agency, as the sole agency for administering or supervising the administration of the State’s health planning functions under the plan;
(B) provide for the establishment of a State
health planning council, which shall include
representatives of Federal, State, and local
agencies (including as an ex officio member, if
there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual
whom the Secretary of Veterans Affairs shall
have designated to serve on such council as
the representative of the hospitals or other
health care facilities of such Department
which are located in such State) and nongovernmental organizations and groups concerned with health (including representation
of the regional medical program or programs
included in whole or in part within the State),
and of consumers of health services, to advise
such State agency in carrying out its functions under the plan, and a majority of the
membership of such council shall consist of
representatives of consumers of health services;
(C) set forth policies and procedures for the
expenditure of funds under the plan, which, in
the judgment of the Secretary, are designed to
provide for comprehensive State planning for
health services (both public and private and
including home health care), including the facilities and persons required for the provision
of such services, to meet the health needs of
the people of the State and including environmental considerations as they relate to public
health;
(D) provide for encouraging cooperative efforts among governmental or nongovern-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

mental agencies, organizations and groups
concerned with health services, facilities, or
manpower, and for cooperative efforts between
such agencies, organizations, and groups and
similar agencies, organizations, and groups in
the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances
satisfactory to the Secretary that the funds
paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise
be made available by the State for the purpose
of comprehensive health planning and not to
supplant such non-Federal funds;
(F) provide such methods of administration
(including methods relating to the establishment and maintenance of personnel standards
on a merit basis, except that the Secretary
shall exercise no authority with respect to the
selection, tenure of office, and compensation
of any individual employed in accordance with
such methods) as are found by the Secretary
to be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make
such reports, in such form and containing such
information, as the Secretary may from time
to time reasonably require, and will keep such
records and afford such access thereto as the
Secretary finds necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from
time to time, but not less often than annually,
review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State
to develop a program for capital expenditures
for replacement, modernization, and expansion
which is consistent with an overall State plan
developed in accordance with criteria established by the Secretary after consultation
with the State which will meet the needs of
the State for health care facilities, equipment,
and services without duplication and otherwise in the most efficient and economical
manner, and (ii) provide that the State agency
furnishing such assistance will periodically review the program (developed pursuant to
clause (i)) of each health care facility in the
State and recommend appropriate modification thereof;
(J) provide for such fiscal control and fund
accounting procedures as may be necessary to
assure proper disbursement of and accounting
for funds paid to the State under this subsection; and
(K) contain such additional information and
assurances as the Secretary may find necessary to carry out the purposes of this subsection.
(3)(A) From the sums appropriated for such
purpose for each fiscal year, the several States
shall be entitled to allotments determined, in
accordance with regulations, on the basis of the
population and the per capita income of the respective States; except that no such allotment
to any State for any fiscal year shall be less
than 1 per centum of the sum appropriated for

Page 146

such fiscal year pursuant to paragraph (1). Any
such allotment to a State for a fiscal year shall
remain available for obligation by the State, in
accordance with the provisions of this subsection and the State’s plan approved thereunder, until the close of the succeeding fiscal
year.
(B) The amount of any allotment to a State
under subparagraph (A) for any fiscal year which
the Secretary determines will not be required by
the State, during the period for which it is
available, for the purposes for which allotted
shall be available for reallotment by the Secretary from time to time, on such date or dates
as he may fix, to other States with respect to
which such a determination has not been made,
in proportion to the original allotments to such
States under subparagraph (A) for such fiscal
year, but with such proportionate amount for
any of such other States being reduced to the
extent it exceeds the sum the Secretary estimates such State needs and will be able to use
during such period; and the total of such reductions shall be similarly reallotted among the
States whose proportionate amounts were not so
reduced. Any amount so reallotted to a State
from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of
its allotment under subparagraph (A) for such
fiscal year.
(4) From each State’s allotment for a fiscal
year under this subsection, the State shall from
time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved
under this subsection. Such payments shall be
made on the basis of estimates by the Secretary
of the sums the State will need in order to perform the planning under its approved State plan
under this subsection, but with such adjustments as may be necessary to take account of
previously made underpayments or overpayments. The ‘‘Federal share’’ for any State for
purposes of this subsection shall be all, or such
part as the Secretary may determine, of the cost
of such planning, except that in the case of the
allotments for the fiscal year ending June 30,
1970, it shall not exceed 75 per centum of such
cost.
(b) Project grants for areawide health planning;
authorization
of
appropriations;
prerequisites for grants; application; contents
(1)(A) The Secretary is authorized, during the
period beginning July 1, 1966, and ending June
30, 1974, to make, with the approval of the State
agency administering or supervising the administration of the State plan approved under subsection (a) of this section, project grants to any
other public or nonprofit private agency or organization (but with appropriate representation of
the interests of local government where the recipient of the grant is not a local government or
combination thereof or an agency of such government or combination) to cover not to exceed
75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other
local area plans for coordination of existing and
planned health services, including the facilities
and persons required for provision of such serv-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ices; and including the provision of such services
through home health care; except that in the
case of project grants made in any State prior to
July 1, 1968, approval of such State agency shall
be required only if such State has such a State
plan in effect at the time of such grants. No
grant may be made under this subsection after
June 30, 1970, to any agency or organization to
develop or revise health plans for an area unless
the Secretary determines that such agency or
organization provides means for appropriate representation of the interests of the hospitals,
other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June
30, 1967, $7,500,000 for the fiscal year ending June
30, 1968, $10,000,000 for the fiscal year ending
June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year
ending June 30, 1971, $30,000,000 for the fiscal
year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for
the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State
agency administering or supervising the administration of the State plan approved under subsection (a) of this section with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region
or area has been filed by any other agency or organization qualified to receive such a grant, and
(ii) such State agency certifies, and the Secretary finds, that ample opportunity has been
afforded to qualified agencies and organizations
to file application for such a grant with respect
to such region or area and that it is improbable
that, in the foreseeable future, any agency or organization which is qualified for such a grant
will file application therefor.
(2)(A) In order to be approved under this subsection, an application for a grant under this
subsection must contain or be supported by reasonable assurances that there has been or will be
established, in or for the area with respect to
which such grant is sought, an areawide health
planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health
(including representatives of the interests of
local government of the regional medical program for such area, and of consumers of health
services). A majority of the members of such
council shall consist of representatives of consumers of health services.
(B) In addition, an application for a grant
under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision
for assisting health care facilities in its area to
develop a program for capital expenditures for
replacement, modernization, and expansion
which is consistent with an overall State plan
which will meet the needs of the State and the
area for health care facilities, equipment, and
services without duplication and otherwise in
the most efficient and economical manner.

§ 246

(c) Project grants for training, studies, and demonstrations; authorization of appropriations
The Secretary is also authorized, during the
period beginning July 1, 1966, and ending June
30, 1974, to make grants to any public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of
projects for training, studies, or demonstrations
looking toward the development of improved or
more effective comprehensive health planning
throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the
fiscal year ending June 30, 1968, $5,000,000 for the
fiscal year ending June 30, 1969, $7,500,000 for the
fiscal year ending June 30, 1970, $8,000,000 for the
fiscal year ending June 30, 1971, $10,000,000 for
the fiscal year ending June 30, 1972, $12,000,000
for the fiscal year ending June 30, 1973, and
$4,700,000 for the fiscal year ending June 30, 1974.
(July 1, 1944, ch. 373, title III, § 314, 58 Stat. 693;
July 3, 1946, ch. 538, § 9, 60 Stat. 424; June 16, 1948,
ch. 481, § 5, 62 Stat. 468; 1953 Reorg. Plan No. 1,
§§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631;
Aug. 1, 1956, ch. 852, § 18, 70 Stat. 910; Pub. L.
85–544, § 1, July 22, 1958, 72 Stat. 400; Pub. L.
87–395, § 2(a)–(d), Oct. 5, 1961, 75 Stat. 824; Pub. L.
87–688, § 4(a)(1), Sept. 25, 1962, 76 Stat. 587; Pub. L.
89–109, § 4, Aug. 5, 1965, 79 Stat. 436; Pub. L.
89–749, § 3, Nov. 3, 1966, 80 Stat. 1181; Pub. L.
90–174, §§ 2(a)–(f), 3(b)(2), 8(a), (b), 12(d), Dec. 5,
1967, 81 Stat. 533–535, 540, 541; Pub. L. 91–296, title
I, § 111(b), title IV, § 401(b)(1)(C), (D), June 30,
1970, 84 Stat. 340, 352; Pub. L. 91–513, title I, § 3(b),
Oct. 27, 1970, 84 Stat. 1241; Pub. L. 91–515, title II,
§§ 220, 230, 240, 250, 260(a)–(c)(1), 282, Oct. 30, 1970,
84 Stat. 1304–1306, 1308; Pub. L. 91–616, title III,
§ 331, Dec. 31, 1970, 84 Stat. 1853; Pub. L. 91–648,
title IV, § 403, Jan. 5, 1971, 84 Stat. 1925, as
amended Pub. L. 95–454, title VI, § 602(c), Oct. 13,
1978, 92 Stat. 1189; Pub. L. 92–255, title IV,
§ 403(a), Mar. 21, 1972, 86 Stat. 77; Pub. L. 93–45,
title I, § 106, June 18, 1973, 87 Stat. 92; Pub. L.
93–151, § 8, Nov. 9, 1973, 87 Stat. 568; Pub. L. 94–63,
title I, § 102, title V, § 501(b), title VII, § 701(a),
(b), July 29, 1975, 89 Stat. 304, 346, 352; Pub. L.
94–484, title IX, § 905(b)(1), Oct. 12, 1976, 90 Stat.
2325; Pub. L. 95–83, title III, § 302, Aug. 1, 1977, 91
Stat. 387; Pub. L. 95–454, title VI, § 602(c), Oct. 13,
1978, 92 Stat. 1189; Pub. L. 95–622, title I, § 109,
Nov. 9, 1978, 92 Stat. 3417; Pub. L. 95–626, title II,
§ 201(a), (b)(2), Nov. 10, 1978, 92 Stat. 3570; Pub. L.
96–32, § 6(e), (f), July 10, 1979, 93 Stat. 83; Pub. L.
96–79, title I, § 115(k)(2), Oct. 4, 1979, 93 Stat. 610;
Pub. L. 96–398, title I, § 107(d), Oct. 7, 1980, 94
Stat. 1571; Pub. L. 97–35, title IX, § 902(b), Aug.
13, 1981, 95 Stat. 559; Pub. L. 99–117, § 12(a), Oct.
7, 1985, 99 Stat. 495; Pub. L. 102–54, § 13(q)(1)(D),
June 13, 1991, 105 Stat. 279.)
AMENDMENTS
1991—Subsec. (a)(2)(B). Pub. L. 102–54 substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’, ‘‘Secretary of Veterans Affairs’’ for ‘‘Administrator of Veterans’ Affairs’’ and ‘‘such Department’’
for ‘‘such Administration’’.
1985—Subsec. (g). Pub. L. 99–117 directed that subsec.
(g) be repealed. Previously, subsec. (g) was repealed by
Pub. L. 96–398. See 1980 Amendment note below.
1981—Subsec. (d). Pub. L. 97–35 struck out subsec. (d)
which related to grants for services, form, manner, etc.,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

of application, review of activities undertaken, allotments, and authorization of appropriations.
1980—Subsec. (g). Pub. L. 96–398 struck out subsec. (g)
which related to application, procedures applicable,
amount, etc., for State mental health program grants.
1979—Subsec. (d)(2)(C)(ii). Pub. L. 96–32, § 6(e), substituted ‘‘uniform national health program reporting
system’’ for ‘‘uniform national reporting system’’.
Subsec. (d)(4)(A). Pub. L. 96–32, § 6(f), in provision following subd. (II) of cl. (ii), substituted ‘‘the preceding
provisions of this subparagraph’’ for ‘‘clauses (i) and
(ii)’’ and ‘‘amount’’ for ‘‘amounts’’ and inserted provision that if the amount appropriated for a fiscal year
is equal to or less than the amount appropriated for fiscal year ending Sept. 30, 1979, the total amount of
grants for a State health authority shall be an amount
which bears the same ratio to the amount appropriated
as the total amount of grants received by such authority from appropriations for fiscal year ending Sept. 30,
1979, bears to the amount appropriated for that fiscal
year.
Subsec. (g)(2)(D)(iv). Pub. L. 96–79 substituted ‘‘a plan
which is consistent with the State health plan in effect
for the State under section 300m–3(c) of this title and’’
for ‘‘a plan’’.
1978—Subsec. (d). Pub. L. 95–626, § 201(b)(2), completely
revised subsec. (d) under which the Secretary is authorized to make grants to State health authorities to assist in meeting the costs of providing comprehensive
public health services by including requirements that
the States submit an application outlining how funds
will be used to supplement non-Federal support for the
provision of public health services in the State, by setting out formulae under which funds will be made
available to States including definitions of ‘‘applicable
grant computation percentage’’ and ‘‘State and local
expenditures for comprehensive public health services’’, by requiring implementation of a national health
program reporting system to assure accountability for
expenditure of funds, and by authorizing appropriations
of $150,000,000 for fiscal year ending Sept. 30, 1980, and
$170,000,000 for fiscal year ending Sept. 30, 1981.
Subsec. (d)(7)(A). Pub. L. 95–626, § 201(a)(1), inserted
provision authorizing an appropriation of $103,000,000
for fiscal year ending Sept. 30, 1979.
Subsec. (d)(7)(B). Pub. L. 95–626, § 201(a)(2), inserted
provision authorizing an appropriation of $20,000,000 for
fiscal year ending Sept. 30, 1979.
Subsec. (f). Pub. L. 95–454 designated existing provisions of section 403 of Pub. L. 91–648 (see 1971 Amendment note below) as subsec. (a) thereof and added subsec. (b) thereto repealing subsec. (f) of this section as
subsec. (f) of this section had applied to commissioned
officers of the Public Health Service.
Subsec. (g). Pub. L. 95–622 substituted provisions relating to grants for State mental health programs for
provisions relating to regulations and amendments
with respect to grants to States under subsecs. (a) and
(d) and reduction and suspension of subsec. (a) and (d)
grant payments.
1977—Subsec. (d)(7)(A). Pub. L. 95–83, § 302(a), substituted provision for an appropriation authorization
for fiscal year ending Sept. 30, 1977, for prior such authorization for fiscal year 1977, and authorized appropriation of $106,750,000 for fiscal year ending Sept. 30,
1978.
Subsec. (d)(7)(B). Pub. L. 95–83, § 302(b), substituted
provision for an appropriation authorization for fiscal
year ending Sept. 30, 1977, for prior such authorization
for fiscal year 1977, and authorized appropriation of
$12,680,000 for fiscal year ending Sept. 30, 1978.
1976—Subsec. (g)(4)(B). Pub. L. 94–484 defined ‘‘State’’
to include the Northern Mariana Islands.
1975—Subsec. (d). Pub. L. 94–63, §§ 102, 701(a), substituted provisions relating to grants made pursuant to
allotments to State health and mental health authorities for meeting the costs of providing comprehensive
public health services, for provisions relating to grants
made pursuant to appropriations for fiscal year ending
June 30, 1968 to fiscal year ending June 30, 1975, to

Page 148

State health or mental health authorities to aid in the
establishment and maintenance of adequate public
health services, including the training of personnel for
State and local health work.
Subsec. (e). Pub. L. 94–63, §§ 501(b), 701(b), struck out
subsec. (e) which authorized appropriations from fiscal
year ending June 30, 1968 through fiscal year ending
June 30, 1975 for project grants for health services and
related training, set forth procedures for making such
grants, and prohibited grants after the fiscal year ending June 30, 1975, for provisions of this chapter amended
by title VII of the Health Revenue Sharing and Health
Services Act of 1975.
1973—Subsec. (a)(1). Pub. L. 93–45, § 106(a)(1), authorized appropriations of $10,000,000 for fiscal year ending
June 30, 1974.
Subsec. (b)(1)(A). Pub. L. 93–45, § 106(a)(2), (b), authorized appropriations of $25,100,000 for fiscal year ending
June 30, 1974, and extended period for making project
grants from June 30, 1973, to June 30, 1974.
Subsec. (c). Pub. L. 93–45, § 106(a)(3), (b), authorized
appropriations of $4,700,000 for fiscal year ending June
30, 1974, and extended period for grants from June 30,
1973, to June 30, 1974.
Subsec. (d)(1). Pub. L. 93–45, § 106(a)(4), authorized appropriations of $90,000,000 for fiscal year ending June 30,
1974.
Subsec. (e). Pub. L. 93–151 prohibited use of appropriated funds for lead based paint poisoning control.
Pub. L. 93–45, § 106(a)(5), authorized appropriations of
$230,700,000 for fiscal year ending June 30, 1974, and prohibited any grant for such fiscal year to cover cost of
services described in cl. (1) or (2) of the first sentence
if a grant or contract to cover cost of such services
may be made or entered into from funds authorized to
be appropriated for such fiscal year under an appropriations authorization in any provision of this chapter
(other than this subsection) amended by title I of the
Health Programs Extension Act of 1973.
1972—Subsec. (d)(2)(K). Pub. L. 92–255 required State
plans to provide for licensing of facilities for treatment
and rehabilitation of persons with drug abuse and other
drug dependence problems and for expansion of State
mental health programs and other prevention and
treatment programs in the field of drug abuse and drug
dependence.
1971—Subsec. (f). Pub. L. 91–648, § 403(a), as amended
by Pub. L. 94–454, § 602(c), repealed subsec. (f) which authorized the Secretary to arrange the interchange of
personnel with States to aid in discharge of responsibilities in field of health care, except as subsec. (b) applied
to commissioned officers of the Public Health Service.
See 1978 Amendment note above.
1970—Pub. L. 91–515, § 282, substituted ‘‘Secretary’’ for
‘‘Surgeon General’’ in subsecs. (a)(1), (a)(2)(C), (E) to
(H), (K), (a)(3)(B), (a)(4), (b)(1)(A), (c), (d)(1), (d)(2)(C),
(F) to (H), (J), (d)(4)(A), (d)(6), and (g)(1) to (3).
Subsec. (a)(1). Pub. L. 91–515, § 220(a), extended period
for making grants to States from June 30, 1970 to June
30, 1973, and authorized appropriations for the fiscal
years ending June 30, 1971, June 30, 1972, and June 30,
1973.
Subsec. (a)(2)(B). Pub. L. 91–515, § 220(b), (c), inserted
provisions authorizing appointment of an exofficio
member from representatives of Federal, State, and
local agencies involved, and requiring representation of
the regional medical program or programs included in
whole or in part within the State.
Subsec. (a)(2)(C). Pub. L. 91–515, § 220(d), inserted ‘‘and
including home health care’’ after ‘‘private’’ and ‘‘and
including environmental considerations as they relate
to public health’’ after ‘‘people of the State’’.
Subsec. (b). Pub. L. 91–515, § 230, redesignated existing
provisions as subsec. (b)(1)(A), and, as so redesignated,
extended period for making project grants from June
30, 1970 to June 30, 1973, inserted ‘‘and including the
provision of such services through home health care’’
after ‘‘such services’’, and authorized appropriations
for the fiscal years ending June 30, 1971, June 30, 1972,
and June 30, 1973, and added subsec. (b)(1)(B) and (b)(2).

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Pub. L. 91–296, § 111(b), inserted provisions requiring
that before grants be made to agencies or organizations
to develop or revise health plans for an area the Secretary determine that the agency or organization provides means for appropriate representation of the interests of the hospitals, practicing physicians, and the
general public.
Subsec. (c). Pub. L. 91–515, § 240, extended period for
making grants from June 30, 1970, to June 30, 1973, and
authorized appropriations for the fiscal years ending
June 30, 1971, June 30, 1972, and June 30, 1973.
Subsec. (d)(1). Pub. L. 91–515, § 250(a), authorized appropriations for fiscal years ending June 30, 1971, June
30, 1972, and June 30, 1973.
Pub. L. 91–296, § 401(b)(1)(C), struck out except which
provided for use of up to 1 per centum by Secretary for
evaluation.
Subsec. (d)(2)(C). Pub. L. 91–515, § 250(b), inserted provisions requiring State plan to contain assurances that
the plan is compatible with total health program of the
State.
Subsec. (d)(2)(K). Pub. L. 91–513 added subpar. (K).
Subsec. (d)(2)(L). Pub. L. 91–616 added subpar. (L).
Subsec. (e). Pub. L. 91–515, § 260(a), (b), (c)(1), inserted
provisions authorizing appropriations for fiscal years
ending June 30, 1971, June 30, 1972, and June 30, 1973,
provisions authorizing grants to cover part of cost of
equity requirements and amortization of loans on facilities acquired from the Office of Economic Opportunity or construction in connection with any program
or project transferred from the Office of Economic Opportunity, and provisions requiring the application for
any grant made under this subsection to be referred for
review and comment to the appropriate areawide
health planning agency, or, if no such agency is in the
area, then to such other public or nonprofit private
agency or organization (if any) which performs similar
functions.
Pub. L. 91–296, § 401(b)(1)(D), struck out provision for
use of up to 1 per centum of appropriation for grants
under subsec. (e) by the Secretary for evaluation.
1967—Subsec. (a)(1). Pub. L. 90–174, § 2(a)(1), extended
period for making grants to States from June 30, 1968,
to June 30, 1970, increased appropriations authorization
for fiscal year ending June 30, 1968, from $5,000,000 to
$7,000,000, and authorized appropriations of $10,000,000
and $15,000,000 for fiscal years ending June 30, 1969, and
1970, respectively.
Subsec. (a)(2)(I) to (K). Pub. L. 90–174, § 2(a)(2), added
subpar. (I) and redesignated former subpars. (I) and (J)
as (J) and (K), respectively.
Subsec. (a)(4). Pub. L. 90–174, § 2(a)(3), limited Federal
share of expenditures, in case of allotments for fiscal
year ending June 30, 1968, to 75 per centum of cost of
planning.
Subsec. (b). Pub. L. 90–174, § 2(b)(1), (2), extended period for making grants to public or nonprofit private
organizations from June 30, 1968, to June 30, 1970, and
authorized appropriations of $10,000,000 and $15,000,000
for fiscal years ending June 30, 1969, and 1970, respectively, and provided for appropriate representation of
interests of local government where recipient of grant
is not a local government or combination thereof or an
agency of such government or combination, respectively.
Subsec. (c). Pub. L. 90–174, § 2(c), extended period for
making grants to public or nonprofit private organizations from June 30, 1968, to June 30, 1970, and authorized appropriations of $5,000,000 and $7,500,000 for fiscal
years ending June 30, 1969, and 1970, respectively.
Subsec. (d)(1). Pub. L. 90–174, §§ 2(d)(1), 8(a), increased
appropriations authorization for fiscal year ending
June 30, 1968, from $62,500,000 to $70,000,000, and authorized appropriations of $90,000,000 and $100,000,000 for fiscal years ending June 30, 1969, and 1970, respectively,
and made program evaluation funds available for any
fiscal year ending after June 30, 1968, respectively.
Subsec. (d)(5). Pub. L. 90–174, § 2(d)(2), made Federal
share of 662⁄3 per centum applicable to the Trust Territory of the Pacific Islands.

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Subsec. (d)(7). Pub. L. 90–174, § 2(d)(3), provided for an
allocation of 70 per centum of funds for provision under
the State plan of services in communities of the State.
Subsec. (e). Pub. L. 90–174, §§ 2(e), 3(b)(2), 8(b), increased appropriations authorization for fiscal year
ending June 30, 1968, from $62,500,000 to $90,000,000, authorized appropriations of $95,000,000 and $80,000,000 for
fiscal years ending June 30, 1969, and 1970, respectively,
inserted ‘‘(including related training)’’ after ‘‘providing
services’’ in cl. (1), substituted ‘‘developing’’ for ‘‘stimulating’’ and inserted ‘‘(including related training)’’
after ‘‘health services’’ in cl. (2), struck out cl. (3)
which authorized grants to cover part of cost of undertaking studies, demonstrations, or training designed to
develop new methods or improve existing methods of
providing health services, and made program evaluation funds available for any fiscal year ending after
June 30, 1968.
Subsec. (f)(5). Pub. L. 90–174, § 12(d)(1), inserted ‘‘for’’
before ‘‘the expenses of travel’’.
Subsec. (f)(6), (8). Pub. L. 90–174, § 12(d)(2), substituted
‘‘Department’’ for ‘‘Service’’.
Subsec. (g)(4)(B). Pub. L. 90–174, § 2(f), defined ‘‘State’’
to include the Trust Territory of the Pacific Islands.
1966—Subsec. (a). Pub. L. 89–749 substituted provisions authorizing the Surgeon General to make grants
to States to assist in comprehensive and continuing
planning for their current and future health needs, authorizing appropriations therefor, setting out the requirements for an acceptable State plan for comprehensive State health planning, covering the allotting of
the appropriated sums to the States, and the payment
of the allotted funds, for provisions authorizing the
Surgeon General, through the use of grants and other
assistance, to help local programs of prevention, treatment, and control of venereal diseases, covering the
payment of the costs of assistance by personnel of the
Public Health Service to assist in carrying out the purposes of the section with respect to venereal disease,
and authorizing the appropriation of funds.
Subsec. (b). Pub. L. 89–749 substituted provisions for
project grants by the Surgeon General covering the development of comprehensive regional, metropolitan, or
local coordination of existing and planned health facilities and persons required for providing services and the
authorization of appropriations of $5,000,000 for fiscal
1967 and $7,500,000 for fiscal 1968 for provisions authorizing the appropriation of funds to enable the Surgeon
General to aid in the development of measures for the
local prevention, treatment, and control of tuberculosis.
Subsec. (c). Pub. L. 89–749 substituted provisions for
project grants for the development of improved or more
effective comprehensive health planning throughout
the United States and the authorization of appropriations of $1,500,000 for fiscal 1967 and $2,500,000 for fiscal
1968 for provisions authorizing the Surgeon General to
assist, through grants and otherwise, in the establishment and maintenance of adequate public health services by States, counties, health districts, and other political subdivisions, authorizing appropriations therefor, and covering the allotment, payment, and allocation of appropriated funds.
Subsec. (d). Pub. L. 89–749 substituted provisions authorizing grants by the Surgeon General to State
health or mental health authorities to assist in establishing and maintaining adequate public health services, setting out the requirements for an acceptable
State plan for the supplying of public health services,
authorizing an appropriation of $62,500,000 for fiscal
1968, the allotment of appropriated funds, payments to
States, and the determination of the Federal share for
provisions covering the allotment of appropriated funds
among the several States on the basis of population, incidence of venereal disease, tuberculosis, mental health
problems, and the financial needs of the various States.
Subsec. (e). Pub. L. 89–749 substituted provisions for
project grants for health services development to public or private nonprofit agencies and for the authorization of an appropriation of $62,500,000 for fiscal 1968 for

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

provisions covering the establishment and maintenance
of community programs of heart disease control and
the allotments and appropriations therefor.
Subsec. (f). Pub. L. 89–749 substituted provisions covering the interchange of personnel with States, the application of statutes covering Federal employees to
interchanged personnel, and the coverage of State officers and employees, for provisions for the determination and certification of amounts paid to each State
from allotments thereto.
Subsec. (g). Pub. L. 89–749 substituted provisions for
consultation with State health planning agencies concerning regulations and amendments with respect to
grants to States, the reduction of payments, cessation
of payments for non-compliance, and definitions, for
provisions limiting the expending of grant funds for
purposes specified by statute and by the agency, organization, or institution to which payment was made.
Subsecs. (h) to (m). Pub. L. 89–749 struck out subsecs.
(h) to (m) which dealt, respectively, with requirement
that State funds be provided for same purpose as that
for which allotted funds are spent, cessation of Federal
aid and procedures in connection therewith, promulgation of rules and regulations and consultation with
State health authorities precedent thereto, availability
of appropriated funds for administrative expenses including printing and travel expenses, applicability of
section to Guam and Samoa, and reduction of payments commensurate to expense of detailing of Public
Health Service personnel to States.
1965—Subsec. (c). Pub. L. 89–109 substituted ‘‘first six
fiscal years ending after June 30, 1961’’ for ‘‘first five
fiscal years ending after June 30, 1961’’ and ‘‘$5,000,000’’
for ‘‘$2,500,000’’.
1962—Subsec. (l). Pub. L. 87–688 inserted ‘‘and American Samoa’’, ‘‘or American Samoa’’, and ‘‘or American
Samoa, respectively’’ after ‘‘Guam’’.
1961—Subsec. (c). Pub. L. 87–395, § 2(a)–(c), substituted
‘‘of the first five fiscal years ending after June 30, 1961,
the sum of $50,000,000’’ for ‘‘fiscal year a sum not to exceed $30,000,000’’, ‘‘such amount as may be necessary’’
for ‘‘an amount, not to exceed $3,000,000’’, ‘‘$2,500,000’’
for ‘‘$1,000,000’’, and provided that when an appropriating act provides that the amounts it specifies are available only for allotments and payments for such services
and activities under this subsection as specified in such
act, the requirements of subsec. (h) shall apply to such
allotments and payments.
Subsec. (m). Pub. L. 87–395, § 2(d), added subsec. (m).
1958—Subsec. (c). Pub. L. 85–544 designated existing
provisions of second sentence as cl. (1) and added cl. (2).
1956—Subsec. (l). Act Aug. 1, 1956, added subsec. (l).
1948—Subsec. (e). Act June 16, 1948, § 5(a), added subsec. (e) to provide for community programs of heart
disease control. Former subsec. (e) redesignated (f).
Subsec. (f). Act June 16, 1948, § 5(a), (b), redesignated
former subsec. (e) as (f) and inserted proviso relating to
determination and certification of amounts to be paid
under subsec. (e). Former subsec. (f) redesignated (g).
Subsec. (g). Act June 16, 1948, § 5(a), (c), redesignated
former subsec. (f) as (g) and brought subsecs. (e) and
(f)(1) within the provisions of this subsection. Former
subsec. (g) redesignated (h).
Subsec. (h). Act June 16, 1948, § 5(a), (d), redesignated
former subsec. (g) as (h) and made subsection applicable to agencies, institutions or other organizations
specified in subsec. (f)(1). Former subsec. (h) redesignated (i).
Subsec. (i). Act June 16, 1948, § 5(a), (e), redesignated
former subsec. (h) as (i), made subsection applicable to
subsec. (e), and made technical changes as a result of
the renumbering of subsections. Former subsec. (i) redesignated (j).
Subsecs. (j), (k). Act June 16, 1948, § 5(a), redesignated
former subsecs. (i) and (j) as (j) and (k), respectively.
1946—Subsec. (c). Act July 3, 1946, increased annual
appropriation from $20,000,000 to $30,000,000, and increased annual amount available to provide demonstrations and to train personnel for State and local health
work from $2,000,000 to $3,000,000.

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Subsec. (d). Act July 3, 1946, provided that Surgeon
General shall give special consideration to the extent
of the mental health problem as well as other special
problems.
Subsecs. (f), (h), (i). Act July 3, 1946, provided that in
matters relating to work in field of mental health Surgeon General shall deal with State mental health authorities where they differ from general health authorities.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see
section 902(h) of Pub. L. 97–35, set out as a note under
section 238l of this title.
EFFECTIVE DATE OF 1980 AMENDMENT
Section 107(d) of Pub. L. 96–398 provided that the
amendment made by that section is effective Sept. 30,
1981. See Repeals note below.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective one year after
Oct. 4, 1979, see section 129(a) of Pub. L. 96–79.
EFFECTIVE DATE OF 1978 AMENDMENTS
Section 201(b)(2) of Pub. L. 95–626 provided that the
amendment made by section is effective Oct. 1, 1979.
Section 403(b) of Pub. L. 91–648, as added by section
602(c) of Pub. L. 95–454, provided that the repeal of subsec. (f) of this section (as applicable to commissioned
officers of the Public Health Service) is effective beginning on the effective date of the Civil Service Reform
Act of 1978, i.e., 90 days after Oct. 13, 1978.
EFFECTIVE DATE OF 1975 AMENDMENT
Section 102 of Pub. L. 94–63 provided that the amendment made by that section is effective with respect to
grants made under subsec. (d) of this section from appropriations under such subsection for fiscal years beginning after June 30, 1975.
Amendment by section 501(b) of Pub. L. 94–63 effective July 1, 1975, see section 608 of Pub. L. 94–63, set out
as a note under section 247b of this title.
EFFECTIVE DATE OF 1971 AMENDMENT
Repeal of subsec. (f) of this section (less applicability
to commissioned officers of the Public Health Service)
by section 403(a) of Pub. L. 91–648, as amended by Pub.
L. 94–454, § 602(c), effective sixty days after Jan. 5, 1971,
see section 404 of Pub. L. 91–648, set out as an Effective
Date note under section 3371 of Title 5, Government Organization and Employees.
EFFECTIVE DATE OF 1970 AMENDMENTS
Section 260(c)(2) of Pub. L. 91–515 provided that: ‘‘The
amendment made by paragraph (1) [amending this section] shall be effective with respect to grants under section 314(c) of the Public Health Service Act [subsec. (e)
of this section] which are made after the date of enactment of this Act [Oct. 30, 1970.]’’
Section 401(b)(1) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to appropriations for fiscal years beginning after
June 30, 1970.
EFFECTIVE DATE OF 1967 AMENDMENT
Section 2(d)(2), (f) of Pub. L. 90–174 provided that the
amendments made by that section are effective July 1,
1968.
Section 3(b) of Pub. L. 90–174 provided that the
amendment of this section, the repeal of section 291n of
this title, and the enactment of provisions set out as a
note under section 242b of this title by such section 3(b)
is effective with respect to appropriations for fiscal
years ending after June 30, 1967.
EFFECTIVE DATE OF 1966 AMENDMENT
Section 6 of Pub. L. 89–749 provided in part that: ‘‘The
amendments made by section 3 [amending this section]

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shall become effective as of July 1, 1966, except that the
provisions of section 314 of the Public Health Service
Act [this section] as in effect prior to the enactment of
this Act shall be effective until July 1, 1967, in lieu of
the provisions of subsections (d) and (e), and the provisions of subsections (g) insofar as they relate to such
subsections (d) and (e), of section 314 of the Public
Health Service Act [this section] as amended by this
Act.’’
EFFECTIVE DATE OF 1962 AMENDMENT
Section 4(b) of Pub. L. 87–688 provided that: ‘‘The
amendments made by this section [amending this section and sections 291g, 291i, and 291t of this title] shall
become effective July 1, 1962.’’
EFFECTIVE AND TERMINATION DATE OF 1958
AMENDMENT
Section 2 of Pub. L. 85–544 provided that: ‘‘The
amendment made by the first section of this Act
[amending this section] shall be applicable only to the
fiscal years beginning July 1, 1958, and July 1, 1959.’’
EFFECTIVE DATE OF 1956 AMENDMENT
Section 18 of act Aug. 1, 1956, provided that the
amendment made by that section is effective July 1,
1956.
REPEALS
The directory language of, but not the amendment
made by, Pub. L. 96–398, title I, § 107(d), cited as a credit
to this section and set out as an Effective Date of 1980
Amendment note above, which provided for repeal of
subsec. (g) of this section, effective Sept. 30, 1981, was
repealed by section 902(e)(1) of Pub. L. 97–35, title IX,
Aug. 13, 1981, 95 Stat. 560, effective Oct. 1, 1981.
TRANSFER OF FUNCTIONS
Functions, powers, and duties of Secretary of Health
and Human Services under subsecs. (a)(2)(F) and
(d)(2)(F) of this section, insofar as relates to the prescription of personnel standards on a merit basis,
transferred to Office of Personnel Management, see section 4728(a)(3)(C) of this title.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
YEAR 2000 HEALTH OBJECTIVES PLANNING
Pub. L. 101–582, Nov. 15, 1990, 104 Stat. 2867, provided
for grants for State plans regarding health objectives
for year 2000, prior to repeal by Pub. L. 102–531, title I,
§ 105, Oct. 27, 1992, 106 Stat. 3474.
CONGRESSIONAL FINDINGS AND DECLARATION
Section 201(b)(1) of Pub. L. 95–626 provided that: ‘‘The
Congress finds and declares that—
‘‘(A) individual health status can be effectively and
economically improved through an adequate investment in community public health programs and services;
‘‘(B) the Federal Government and the States and
their communities share in the financial responsibility for funding public health programs;
‘‘(C) the Federal contribution to funds for public
health programs should serve as an incentive to an
additional investment by State and local governments;
‘‘(D) existing categorical programs of Federal financial assistance to combat specific public health

§ 246

problems should be supplemented by a national program of stable generic support for such public health
activities as the prevention and control of environmental health hazards, prevention and control of diseases, prevention and control of health problems of
particularly vulnerable population groups, and development and regulation of health care facilities and
health services delivery systems; and
‘‘(E) the States and their communities, not the
Federal Government, should have primary responsibility for identifying and measuring the impact of
public health problems and the allocation of resources for their amelioration.’’
Section 2 of Pub. L. 89–749 provided that:
‘‘(a) The Congress declares that fulfillment of our national purpose depends on promoting and assuring the
highest level of health attainable for every person, in
an environment which contributes positively to healthful individual and family living; that attainment of
this goal depends on an effective partnership, involving
close intergovernmental collaboration, official and voluntary efforts, and participation of individuals and organizations; that Federal financial assistance must be
directed to support the marshaling of all health resources—national, State, and local—to assure comprehensive health services of high quality for every person, but without interference with existing patterns of
private professional practice of medicine, dentistry,
and related healing arts.
‘‘(b) To carry out such purpose, and recognizing the
changing character of health problems, the Congress
finds that comprehensive planning for health services,
health manpower, and health facilities is essential at
every level of government; that desirable administration requires strengthening the leadership and capacities of State health agencies; and that support of
health services provided people in their communities
should be broadened and made more flexible.’’
Section 2 of act July 3, 1956, provided that:
‘‘(a) The Congress hereby finds and declares—
‘‘(1) that the latest information on the number and
relevant characteristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis
and rheumatism, and other diseases, injuries, and
handicapping conditions is now seriously out of date;
and
‘‘(2) that periodic inventories providing reasonably
current information on these matters are urgently
needed for purposes such as (A) appraisal of the true
state of health of our population (including both
adults and children), (B) adequate planning of any
programs to improve their health, (C) research in the
field of chronic diseases, and (D) measurement of the
numbers of persons in the working ages so disabled as
to be unable to perform gainful work.
‘‘(b) It is, therefore, the purpose of this Act [see Short
Title of 1956 Amendment note set out under section 201
of this title] to provide (1) for a continuing survey and
special studies to secure on a non-compulsory basis accurate and current statistical information on the
amount, distribution, and effects of illness and disability in the United States and the services received for or
because of such conditions; and (2) for studying methods and survey techniques for securing such statistical
information, with a view toward their continuing improvement.’’
LIMITATION ON GRANTS-IN-AID TO SCHOOLS OF PUBLIC
HEALTH
Section 2 of Pub. L. 85–544, which had limited the authority of the Surgeon General to make grants-in-aid
totaling not to exceed $1,000,000 annually to schools of
public health for fiscal year beginning July 1, 1958, and
July 1, 1959, was repealed by section 2 of Pub. L. 86–720,
Sept. 8, 1960, 74 Stat. 820.
GRANTS TO STATES TO PROVIDE FOR VACCINATION
AGAINST POLIOMYELITIS
The Poliomyelitis Vaccination Assistance Act of 1955,
act Aug. 12, 1955, ch. 863, 69 Stat. 704, as amended Feb.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

15, 1956, ch. 39, 70 Stat. 18, authorized appropriations to
remain available until close of June 30, 1957 and provided for allotments to States, State application for
funds, payments to States, use of funds paid to States,
furnishing of vaccine by Surgeon General, diversion of
Federal funds, supervision over exercise of functions,
and definitions.
APPLICABILITY OF REORGANIZATION PLAN NO. 3 OF 1966
Section 7 of Pub. L. 89–749 provided that: ‘‘The provisions enacted by this Act [amending this section and
sections 242g and 243 of this title] shall be subject to
the provisions of Reorganization Plan No. 3 of 1966 [set
out as a note under section 202 of this title].’’

§ 246a. Bureau of State Services management
fund; establishment; advancements; availability
For the purpose of facilitating the economical
and efficient conduct of operations in the Bureau of State Services which are financed by two
or more appropriations where the costs of operation are not readily susceptible of distribution
as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may
determine to represent a reasonable distribution
of estimated costs among the various appropriations involved may be advanced each year to
this fund and shall be available for expenditure
for such costs under such regulations as may be
prescribed by the Secretary: Provided, That
funds advanced to this fund shall be available
only in the fiscal year in which they are advanced: Provided further, That final adjustments
of advances in accordance with actual costs
shall be effected wherever practicable with the
appropriations from which such funds are advanced.
(Pub. L. 86–703, title II, § 201, Sept. 2, 1960, 74
Stat. 765; Pub. L. 91–515, title II, § 282, Oct. 30,
1970, 84 Stat. 1308.)
CODIFICATION
Section was not enacted as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
1970—Pub. L. 91–515 substituted ‘‘Secretary’’ for ‘‘Surgeon General’’ wherever appearing.

Page 152

§ 247a. Family support groups for Alzheimer’s
disease patients
(a) Establishment; priorities
Subject to available appropriations, the Secretary, acting through the National Institute of
Mental Health, the National Institutes of
Health, and the Administration on Aging, shall
promote the establishment of family support
groups to provide, without charge, educational,
emotional, and practical support to assist individuals with Alzheimer’s disease or a related
memory disorder and members of the families of
such individuals. In promoting the establishment of such groups, the Secretary shall give
priority to—
(1) university medical centers and other appropriate health care facilities which receive
Federal funds from the Secretary and which
conduct research on Alzheimer’s disease or
provide services to individuals with such disease; and
(2) community-based programs which receive
funds from the Secretary, acting through the
Administration on Aging.
(b) National network to coordinate groups
The Secretary shall promote the establishment of a national network to coordinate the
family support groups described in subsection
(a) of this section.
(July 1, 1944, ch. 373, title III, § 316, as added Pub.
L. 99–319, title IV, § 401, May 23, 1986, 100 Stat.
489; amended Pub. L. 103–43, title XX, § 2008(a),
June 10, 1993, 107 Stat. 210.)
PRIOR PROVISIONS
A prior section 247a, act July 1, 1944, ch. 373, title III,
§ 316, as added Nov. 10, 1978, Pub. L. 95–626, title II,
§ 208(a), 92 Stat. 3586; amended Aug. 13, 1981, Pub. L.
97–35, title XXI, § 2193(a)(1)(A), 95 Stat. 826, related to
lead-based paint poisoning prevention programs, prior
to repeal by Pub. L. 97–35, title XXI, § 2193(b)(1), Aug. 13,
1981, 95 Stat. 827.
Another prior section 247a, act July 1, 1944, ch. 373,
title III, § 316, as added Oct. 30, 1970, Pub. L. 91–515, title
II, § 281, 84 Stat. 1307, provided for establishment, composition, qualifications of members, terms of office, vacancies, reappointment, compensation, travel expenses,
and functions of National Advisory Council on Comprehensive Health Planning Programs, prior to repeal by
Pub. L. 93–641, § 5(d), Jan. 4, 1975, 88 Stat. 2275.
AMENDMENTS

§ 247. Omitted
Section, act July 1, 1944, ch. 373, title III, § 315, as
added Oct. 4, 1988, Pub. L. 100–471, § 1, 102 Stat. 2284,
which related to grants for treatment drugs for acquired immune deficiency syndrome, ceased to exist
Mar. 31, 1989, pursuant to subsec. (d) thereof.

1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c)
which read as follows: ‘‘The Secretary shall report to
Congress, not later than one year after May 23, 1986, on
family support groups and the network of such groups
established pursuant to this section.’’

PRIOR PROVISIONS

§ 247b. Project grants for preventive health services

A prior section 247, act July 1, 1944, ch. 373, title III,
§ 315, as added Nov. 10, 1978, Pub. L. 95–626, title II, § 203,
92 Stat. 3578; amended July 10, 1979, Pub. L. 96–32, § 6(h),
93 Stat. 83, related to formula grants to States for preventive health service programs, prior to repeal by
Pub. L. 99–117, § 12(b), Oct. 7, 1985, 99 Stat. 495.
Another prior section 247, acts July 1, 1944, ch. 373,
title III, § 315, 58 Stat. 695; Oct. 30, 1970, Pub. L. 91–515,
title II, § 282, 84 Stat. 1308, provided for publication of
health educational information, prior to repeal by Pub.
L. 93–353, title I, § 102(a), July 23, 1974, 88 Stat. 362. See
section 242o(b) of this title.

(a) Grant authority
The Secretary may make grants to States, and
in consultation with State health authorities, to
political subdivisions of States and to other public entities to assist them in meeting the costs
of establishing and maintaining preventive
health service programs.
(b) Application
No grant may be made under subsection (a) of
this section unless an application therefor has

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

been submitted to, and approved by, the Secretary. Such an application shall be in such
form and be submitted in such manner as the
Secretary shall by regulation prescribe and shall
provide—
(1) a complete description of the type and extent of the program for which the applicant is
seeking a grant under subsection (a) of this
section;
(2) with respect to each such program (A) the
amount of Federal, State, and other funds obligated by the applicant in its latest annual
accounting period for the provision of such
program, (B) a description of the services provided by the applicant in such program in such
period, (C) the amount of Federal funds needed
by the applicant to continue providing such
services in such program, and (D) if the applicant proposes changes in the provision of the
services in such program, the priorities of
such proposed changes, reasons for such
changes, and the amount of Federal funds
needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary
that the program which will be provided with
funds under a grant under subsection (a) of
this section will be provided in a manner consistent with the State health plan in effect
under section 300m–3(c) 1 of this title and in
those cases where the applicant is a State,
that such program will be provided, where appropriate, in a manner consistent with any
plans in effect under an application approved
under section 247 1 of this title;
(4) assurances satisfactory to the Secretary
that the applicant will provide for such fiscal
control and fund accounting procedures as the
Secretary by regulation prescribes to assure
the proper disbursement of and accounting for
funds received under grants under subsection
(a) of this section;
(5) assurances satisfactory to the Secretary
that the applicant will provide for periodic
evaluation of its program or programs;
(6) assurances satisfactory to the Secretary
that the applicant will make such reports (in
such form and containing such information as
the Secretary may by regulation prescribe) as
the Secretary may reasonably require and
keep such records and afford such access
thereto as the Secretary may find necessary
to assure the correctness of, and to verify,
such reports;
(7) assurances satisfactory to the Secretary
that the applicant will comply with any other
conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary
may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) of this section for a grant for a program for which a grant
was previously made under subsection (a) of this
section unless the Secretary determines—
(A) the program for which the application
was submitted is operating effectively to
achieve its stated purpose,
1 See

References in Text note below.

§ 247b

(B) the applicant complied with the assurances provided the Secretary when applying
for such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant
under subsection (a) of this section to determine
if the program assisted by such grant is operating effectively to achieve its stated purposes and
if the recipient is in compliance with the assurances provided the Secretary when applying for
such grant.
(d) Amount of grant; payment
The amount of a grant under subsection (a) of
this section shall be determined by the Secretary. Payments under such grants may be
made in advance on the basis of estimates or by
the way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such
terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(e) Reduction
The Secretary, at the request of a recipient of
a grant under subsection (a) of this section, may
reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents)
or equipment furnished the grant recipient,
and
(2) the amount of the pay, allowances, and
travel expenses of any officer or employee of
the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such
officer or employee,
when the furnishing of such supplies or equipment or the detail of such an officer or employee
is for the convenience of and at the request of
such grant recipient and for the purpose of carrying out a program with respect to which the
grant under subsection (a) of this section is
made. The amount by which any such grant is so
reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the
supplies or equipment, or in detailing the personnel, on which the reduction of such grant is
based, and such amount shall be deemed as part
of the grant and shall be deemed to have been
paid to the grant recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection
(a) of this section shall keep such records as the
Secretary shall by regulation prescribe, including records which fully disclose the amount and
disposition by such recipient of the proceeds of
such grant, the total cost of the undertaking in
connection with which such grant was made,
and the amount of that portion of the cost of the
undertaking supplied by other sources, and such
other records as will facilitate an effective
audit.
(2) The Secretary and the Comptroller General
of the United States, or any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any
books, documents, papers, and records of the re-

§ 247b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cipient of grants under subsection (a) of this section that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment prohibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted
to a State or to an agency or a political subdivision of a State under provisions of Federal law
(other than this section) and which are available
for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection
(a) of this section.
(2) Nothing in this section shall be construed
to require any State or any agency or political
subdivision of a State to have a preventive
health service program which would require any
person, who objects to any treatment provided
under such a program, to be treated or to have
any child or ward treated under such program.
(h) Reports
The Secretary shall include, as part of the report required by section 300u–4 of this title, a report on the extent of the problems presented by
the diseases and conditions referred to in subsection (j) of this section; on the amount of
funds obligated under grants under subsection
(a) of this section in the preceding fiscal year for
each of the programs listed in subsection (j) of
this section; and on the effectiveness of the activities assisted under grants under subsection
(a) of this section in controlling such diseases
and conditions.
(i) Technical assistance
The Secretary may provide technical assistance to States, State health authorities, and
other public entities in connection with the operation of their preventive health service programs.
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for
which are established in paragraph (2), for
grants under subsections (a) and (k)(1) of this
section for preventive health service programs
to immunize without charge children, adolescents, and adults against vaccine-preventable
diseases, there are authorized to be appropriated
such sums as may be necessary. Not more than
10 percent of the total amount appropriated
under the preceding sentence for any fiscal year
shall be available for grants under subsection
(k)(1) of this section for such fiscal year.
(2) For grants under subsection (a) of this section for preventive health service programs for
the provision without charge of immunizations
with vaccines approved for use, and recommended for routine use, there are authorized
to be appropriated such sums as may be necessary.
(k) Additional grants to States, political subdivisions, and other public and nonprofit private
entities
(1) The Secretary may make grants to States,
political subdivisions of States, and other public
and nonprofit private entities for—
(A) research into the prevention and control
of diseases that may be prevented through
vaccination;

Page 154

(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of such
diseases; and
(D) education, training, and clinical skills
improvement activities in the prevention and
control of such diseases for health professionals (including allied health personnel).
(2) The Secretary may make grants to States,
political subdivisions of States, and other public
and nonprofit private entities for—
(A) research into the prevention and control
of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and conditions;
(C) public information and education programs for the prevention and control of such
diseases and conditions; and
(D) education, training, and clinical skills
improvement activities in the prevention and
control of such diseases and conditions for
health professionals (including allied health
personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time,
and containing such information as the Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) of this section
shall apply to grants under this subsection in
the same manner as such subsections apply to
grants under subsection (a) of this section.
(l) Authority to purchase recommended vaccines
for adults
(1) In general
The Secretary may negotiate and enter into
contracts with manufacturers of vaccines for
the purchase and delivery of vaccines for
adults as provided for under subsection (e).
(2) State purchase
A State may obtain additional quantities of
such adult vaccines (subject to amounts specified to the Secretary by the State in advance
of negotiations) through the purchase of vaccines from manufacturers at the applicable
price negotiated by the Secretary under this
subsection.
(m) Demonstration program to improve immunization coverage
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall establish a demonstration program
to award grants to States to improve the provision of recommended immunizations for
children, adolescents, and adults through the
use of evidence-based, population-based interventions for high-risk populations.
(2) State plan
To be eligible for a grant under paragraph
(1), a State shall submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary
may require, including a State plan that de-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

scribes the interventions to be implemented
under the grant and how such interventions
match with local needs and capabilities, as determined through consultation with local authorities.
(3) Use of funds
Funds received under a grant under this subsection shall be used to implement interventions that are recommended by the Task
Force on Community Preventive Services (as
established by the Secretary, acting through
the Director of the Centers for Disease Control
and Prevention) or other evidence-based interventions, including—
(A) providing immunization reminders or
recalls for target populations of clients, patients, and consumers;
(B) educating targeted populations and
health care providers concerning immunizations in combination with one or more other
interventions;
(C) reducing out-of-pocket costs for families for vaccines and their administration;
(D) carrying out immunization-promoting
strategies for participants or clients of public programs, including assessments of immunization status, referrals to health care
providers, education, provision of on-site immunizations, or incentives for immunization;
(E) providing for home visits that promote
immunization through education, assessments of need, referrals, provision of immunizations, or other services;
(F) providing reminders or recalls for immunization providers;
(G) conducting assessments of, and providing feedback to, immunization providers;
(H) any combination of one or more interventions described in this paragraph; or
(I) immunization information systems to
allow all States to have electronic databases
for immunization records.
(4) Consideration
In awarding grants under this subsection,
the Secretary shall consider any reviews or
recommendations of the Task Force on Community Preventive Services.
(5) Evaluation
Not later than 3 years after the date on
which a State receives a grant under this subsection, the State shall submit to the Secretary an evaluation of progress made toward
improving
immunization
coverage
rates
among high-risk populations within the State.
(6) Report to Congress
Not later than 4 years after March 23, 2010,1
the Secretary shall submit to Congress a report concerning the effectiveness of the demonstration program established under this subsection together with recommendations on
whether to continue and expand such program.
(7) Authorization of appropriations
There is authorized to be appropriated to
carry out this subsection, such sums as may
be necessary for each of fiscal years 2010
through 2014.
(July 1, 1944, ch. 373, title III, § 317, as added Pub.
L. 87–868, § 2, Oct. 23, 1962, 76 Stat. 1155; amended

§ 247b

Pub. L. 89–109, § 2, Aug. 5, 1965, 79 Stat. 435; Pub.
L. 91–464, § 2, Oct. 16, 1970, 84 Stat. 988; Pub. L.
92–449, title I, § 101, Sept. 30, 1972, 86 Stat. 748;
Pub. L. 93–354, § 4, July 23, 1974, 88 Stat. 376; Pub.
L. 94–63, title VI, § 601, July 29, 1975, 89 Stat. 346;
Pub. L. 94–317, title II, § 202(a), June 23, 1976, 90
Stat. 700; Pub. L. 94–380, § 2, Aug. 12, 1976, 90
Stat. 1113; Pub. L. 95–626, title II, §§ 202, 204(b)(2),
Nov. 10, 1978, 92 Stat. 3574, 3583; Pub. L. 96–32,
§ 6(i), July 10, 1979, 93 Stat. 83; Pub. L. 97–35, title
IX, § 928, Aug. 13, 1981, 95 Stat. 569; Pub. L. 98–555,
§ 2, Oct. 30, 1984, 98 Stat. 2854; Pub. L. 99–117,
§ 11(c), Oct. 7, 1985, 99 Stat. 495; Pub. L. 100–177,
title I, §§ 110(a), 111, Dec. 1, 1987, 101 Stat. 990, 991;
Pub. L. 101–368, § 2, Aug. 15, 1990, 104 Stat. 446;
Pub. L. 101–502, § 2(a), Nov. 3, 1990, 104 Stat. 1285;
Pub. L. 103–183, title III, § 301(b), Dec. 14, 1993, 107
Stat. 2235; Pub. L. 105–392, title III, § 303, Nov. 13,
1998, 112 Stat. 3586; Pub. L. 106–310, div. A, title
XVII, § 1711, Oct. 17, 2000, 114 Stat. 1152; Pub. L.
111–148, title IV, § 4204(a)–(c), Mar. 23, 2010, 124
Stat. 571, 572.)
REFERENCES IN TEXT
Section 300m–3 of this title, referred to in subsec.
(b)(3), was repealed by Pub. L. 99–660, title VII, § 701(a),
Nov. 14, 1986, 100 Stat. 3799.
Section 247 of this title, referred to in subsec. (b)(3),
was repealed by Pub. L. 99–117, § 12(b), Oct. 7, 1985, 99
Stat. 495.
March 23, 2010, referred to in subsec. (m)(6), was in
the original ‘‘the date of enactment of the Affordable
Health Choices Act’’, and was translated as meaning
the date of enactment of the Patient Protection and
Affordable Care Act, Pub. L. 111–148, to reflect the probable intent of Congress. No act named the ‘‘Affordable
Health Choices Act’’ has been enacted.
AMENDMENTS
2010—Subsec. (j)(1). Pub. L. 111–148, § 4204(c)(1), struck
out ‘‘for each of the fiscal years 1998 through 2005’’ after
‘‘necessary’’.
Subsec. (j)(2). Pub. L. 111–148, § 4204(c)(2), struck out
‘‘after October 1, 1997,’’ after ‘‘routine use,’’.
Subsecs. (l), (m). Pub. L. 111–148, § 4204(a), (b), added
subsecs. (l) and (m).
2000—Subsec. (j)(1). Pub. L. 106–310 substituted ‘‘1998
through 2005’’ for ‘‘1998 through 2002’’ in first sentence.
1998—Subsec. (j)(1). Pub. L. 105–392, § 303(1), substituted ‘‘children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be
appropriated such sums as may be necessary for each of
the fiscal years 1998 through 2002.’’ for ‘‘individuals
against vaccine-preventable diseases, there are authorized to be appropriated $205,000,000 for fiscal year 1991,
and such sums as may be necessary for each of the fiscal years 1992 through 1995.’’
Subsec. (j)(2). Pub. L. 105–392, § 303(2), substituted
‘‘1997’’ for ‘‘1990’’.
1993—Subsec. (j). Pub. L. 103–183, § 301(b)(1), redesignated subpars. (A) and (B) of par. (1) as pars. (1) and (2),
respectively, substituted ‘‘established in paragraph (2)’’
for ‘‘established in subparagraph (B)’’ in par. (1), and
struck out former par. (2), which read as follows: ‘‘For
grants under subsection (a) of this section for preventive health service programs for the prevention, control, and elimination of tuberculosis, and for grants
under subsection (k)(2) of this section, there are authorized to be appropriated $24,000,000 for fiscal year
1988, $31,000,000 for fiscal year 1989, $36,000,000 for fiscal
year 1990, $36,000,000 for fiscal year 1991, and such sums
as may be necessary for each of the fiscal years 1992
through 1995. Not more than 10 percent of the total
amount appropriated under the preceding sentence for
any fiscal year shall be available for grants under subsection (k)(2) of this section for such fiscal year.’’
Subsec. (k)(2). Pub. L. 103–183, § 301(b)(2)(A), (B), redesignated par. (3) as (2) and struck out former par. (2)

§ 247b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

which read as follows: ‘‘The Secretary may make
grants to States, political subdivisions of States, and
other public and nonprofit private entities for—
‘‘(A) research into the prevention, control, and
elimination of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and
research concerning cases of tuberculosis that affect
certain populations;
‘‘(B) demonstration projects for the prevention,
control, and elimination of tuberculosis;
‘‘(C) public information and education programs for
prevention, control, and elimination of tuberculosis;
and
‘‘(D) education, training, and clinical skills improvement activities in the prevention, control, and
elimination of tuberculosis for health professionals,
including allied health personnel.’’
Subsec. (k)(3). Pub. L. 103–183, § 301(b)(2)(B), redesignated par. (4) as (3). Former par. (3) redesignated (2).
Subsec. (k)(4), (5). Pub. L. 103–183, § 301(b)(2)(B), (C),
redesignated par. (5) as (4) and made technical amendments to references to subsections (d), (e), and (f) of
this section and subsection (a) of this section, to reflect
change in references to corresponding provisions of
original act. Former par. (4) redesignated (3).
Subsec. (l). Pub. L. 103–183, § 301(b)(3), struck out subsec. (l) which related to establishment and function of
Advisory Council for the Elimination of Tuberculosis.
1990—Subsec. (j)(1)(A). Pub. L. 101–502, § 2(a)(1), substituted provisions authorizing appropriations for fiscal years 1991 through 1995 for provisions authorizing
appropriations for fiscal years 1988 through 1990.
Subsec. (j)(1)(B). Pub. L. 101–502, § 2(a)(2), substituted
Oct. 1, 1990, for Dec. 1, 1987, and provisions authorizing
appropriations as may be necessary for provisions authorizing appropriations for fiscal years 1988 to 1990.
Subsec. (j)(1)(C). Pub. L. 101–502, § 2(a)(3), struck out
subpar. (C) which, on the implementation of part 2 of
subchapter XIX of this chapter, authorized appropriations for grants under subsec. (a) of this section for fiscal years 1988 to 1990.
Subsec. (j)(2). Pub. L. 101–368, § 2(c), inserted provisions authorizing appropriations of $36,000,000 for fiscal
year 1991, and such sums as may be necessary for fiscal
years 1992 through 1995.
Pub. L. 101–368, § 2(a)(1), substituted ‘‘preventive
health service programs for the prevention, control,
and elimination of tuberculosis’’ for ‘‘preventive health
service programs for tuberculosis’’.
Subsec. (k)(2)(A) to (D). Pub. L. 101–368, § 2(a)(2), substituted ‘‘prevention, control, and elimination’’ for
‘‘prevention and control’’.
Subsec. (l). Pub. L. 101–368, § 2(b), added subsec. (l).
1987—Subsec. (j). Pub. L. 100–177, §§ 110(a), 111(a),
amended subsec. (j) generally, substituting provisions
authorizing appropriations for fiscal years 1988 to 1990
for grants under subsecs. (a) and (k) of this section for
former provisions authorizing appropriations for fiscal
years 1982 to 1987 for grants under subsec. (a) of this
section.
Subsec. (k). Pub. L. 100–177, § 111(b), added subsec. (k).
1985—Subsec. (j). Pub. L. 99–117 amended directory
language of Pub. L. 97–35, § 928(b), to correct a technical
error. See 1981 Amendment note below.
1984—Subsec. (j)(1). Pub. L. 98–555, § 2(a), substituted
‘‘immunize individuals against vaccine-preventable diseases’’ for ‘‘immunize children against immunizable
diseases’’ and inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and
1987.
Subsec. (j)(2). Pub. L. 98–555, § 2(b), inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1985, 1986, and 1987.
1981—Subsec. (a). Pub. L. 97–35, § 928(a), struck out
par. (1) which related to grants to State health authorities, and redesignated par. (2) as entire section and, as
so redesignated, struck out reference to former par. (1).
Subsec. (j). Pub. L. 97–35, § 928(b), as amended by Pub.
L. 99–117, substituted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and

Page 156

1984, for provisions setting forth appropriations
through fiscal year ending Sept. 30, 1981, and provisions
setting forth limitations, conditions, etc., for appropriations.
1979—Subsec. (j)(4), (5). Pub. L. 96–32 added par. (4), redesignated former par. (4) as (5) and, in par. (5) as so redesignated, substituted ‘‘paragraph (1), (2), (3), or (4)’’
for ‘‘paragraph (1), (2), or (3)’’.
1978—Pub. L. 95–626, § 202, amended section generally,
substituting provisions relating to project grants for
preventive health services for provisions relating to
grants for disease control programs.
Subsec. (g)(2). Pub. L. 95–626, § 204(b)(2), struck out
‘‘Except as provided in section 247c of this title,’’ before
‘‘No funds appropriated under any provision of this
chapter’’.
1976—Pub. L. 94–317 amended section generally to include many non-communicable diseases as well as expanding coverage of communicable diseases, increased
appropriations for grants, widened scope of Secretary’s
authority to make grants and enter into contracts to
include nonprofit private entities, and required a report
from the Secretary on the effectiveness of all Federal
and other public and private activities in controlling
the diseases covered under this section.
Subsecs. (j) to (l). Pub. L. 94–380 added subsecs. (j) to
(l).
1975—Subsec. (d)(3). Pub. L. 94–63, § 601(b), inserted authorization of appropriation for fiscal year 1976.
Subsec. (h)(1). Pub. L. 94–63, § 601(a), inserted reference to diseases borne by rodents.
1974—Subsec. (a). Pub. L. 93–354, § 4(1)–(3), substituted
‘‘communicable and other disease control’’ for ‘‘communicable disease control’’, ‘‘communicable and other
diseases’’ for ‘‘communicable diseases’’, and ‘‘communicable and other disease control program’’ for ‘‘communicable disease program’’.
Subsec. (b)(2)(C). Pub. L. 93–354, § 4(1), (4), substituted
‘‘communicable or other disease’’ for ‘‘communicable
disease’’ in cl. (i) and ‘‘communicable and other disease
control’’ for ‘‘communicable disease control’’ in cl. (ii).
Subsecs. (b)(3), (d)(1), (2), (3), (f)(1). Pub. L. 93–354,
§ 4(1), substituted ‘‘communicable and other disease
control’’ for ‘‘communicable disease control’’.
Subsec. (h)(1). Pub. L. 93–354, § 4(1), (5), substituted
‘‘communicable and other disease control’’ for ‘‘communicable disease control’’ in two places and inserted
reference to diabetes mellitus.
Subsec. (i). Pub. L. 93–354, § 4(1), substituted ‘‘communicable and other disease control’’ for ‘‘communicable
disease control’’.
1972—Subsec. (a). Pub. L. 92–449 substituted provision
for grants by the Secretary in consultation with the
State health authority to agencies and political subdivisions of States, for former provision for grants by
the Secretary with the approval of the State health authority to political subdivisions or instrumentalities of
States, incorporated existing provisions in provision
designated as cl. (1), inserting ‘‘, in the area served by
the applicant for the grant,’’, substituted a cl. (2) reading ‘‘design of the applicant’s communicable disease
program to determine its effectiveness’’, for former
provision reading ‘‘levels of performance in preventing
and controlling such diseases’’, struck out appropriations authorization of $75,000,000 and $90,000,000 for fiscal years ending June 30, 1971, and 1972, now covered for
subsequent years in subsec. (d), and struck out provision for use of grants to meet cost of studies to determine the control needs of communities and the means
of best meeting such needs, now covered in subsec.
(h)(1) of this section.
Subsec. (b). Pub. L. 92–449 substituted provisions of
par. (1) respecting applications for grants, submission,
approval, form, and content of applications; par. (2) respecting application requirements; and par. (3) incorporating former subsec. (g) provisions respecting consent of individuals for former definitions provision now
incorporated in subsec. (h) of this section.
Subsec. (c). Pub. L. 92–449 designated existing provisions as par. (1) and among minor punctuation changes

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

inserted ‘‘under grants’’ after ‘‘Payments’’; and redesignated former subsec. (d) as par. (2), inserted ‘‘of the
Government’’ after ‘‘officer or employee’’, substituted
‘‘in detailing the personnel’’ for ‘‘personal services’’,
and struck out provision that reduced amount shall, for
purposes of subsec. (c), be deemed to have been paid to
the agency.
Subsec. (d). Pub. L. 92–449 substituted provisions respecting authorization of appropriations and limitation
on use of funds for provisions respecting grant reduction.
Subsec. (e). Pub. L. 92–449 substituted provisions for
emergency plan development and authorization of appropriations for provisions relating to use of funds.
Subsec. (f). Pub. L. 92–449 substituted provisions respecting conditional limitation on use of funds for provisions for an annual report.
Subsec. (g). Pub. L. 92–449 incorporated former subsec. (f) provisions in introductory text and cl. (3), prescribed a January 1 submission date, and inserted provisions of cls. (1), (2), and (4). Former subsec. (g) consent of individuals provision respecting communicable
disease control and vaccination assistance were covered in subsec. (b)(3) of this section and section 247c(h)
of this title.
Subsec. (h). Pub. L. 92–449 redesignated former subsec. (b) as (h), substituted in introductory text ‘‘this
section’’ for ‘‘this subsection’’, and in par. (1) struck
out ‘‘venereal disease’’ after ‘‘tuberculosis,’’, inserted
‘‘(other than venereal disease)’’ after ‘‘other communicable diseases’’, and included in definition of ‘‘communicable disease control program’’ vaccination programs, laboratory services, and control studies.
Subsec. (i). Pub. L. 92–449 redesignated former subsec.
(e) as (i), inserted reference to agency of a State, and
substituted ‘‘under provisions of Federal law (other
than this chapter)’’ for ‘‘under other provisions of this
chapter or other Federal law’’.
1970—Subsec. (a). Pub. L. 91–464 authorized appropriation of $75,000,000 for fiscal year ending June 30, 1971,
and $90,000,000 for fiscal year ending June 30, 1972, and
made award of grants dependent upon extent of communicable disease and success of programs and permitted use of grants for meeting cost of programs and
studies to control communicable diseases and struck
out reference to purchase of vaccines and use of grants
for salaries and expenses of personnel and to authority
of the Surgeon General.
Subsec. (b). Pub. L. 91–464 substituted definitions of
‘‘communicable disease control program’’ and ‘‘State’’
for definition of ‘‘immunization program’’.
Subsec. (c). Pub. L. 91–464 substituted reference to
Secretary for reference to Surgeon General and struck
out provisions relating to purchasing and furnishing of
vaccines and requirement of obtaining assurances from
recipients of grants.
Subsec. (d). Pub. L. 91–464 substituted reference to
Secretary for reference to Surgeon General and struck
out reference to Public Health Service.
Subsec. (e). Pub. L. 91–464 struck out reference to
title V of the Social Security Act and substituted provisions for the use of funds for the conduct of communicable disease control programs for provisions for the
purchase of vaccine or for organizing, promoting, conducting, or participating in immunization programs.
Subsecs. (f), (g). Pub. L. 91–464 added subsecs. (f) and
(g).
1965—Subsec. (a). Pub. L. 89–109, § 2(a), (b), (d)(1), inserted ‘‘and each of the next three fiscal years’’, substituted ‘‘any fiscal year ending prior to July 1, 1968’’
for ‘‘the fiscal years ending June 30, 1963, and June 30,
1964’’, ‘‘tetanus, and measles’’ for ‘‘and tetanus’’, ‘‘of
preschool age’’ for ‘‘under the age of five years’’, and
‘‘immunization’’ for ‘‘intensive community vaccination’’, and permitted grants to be used to pay costs in
connection with immunization of other infectious diseases.
Subsec. (b). Pub. L. 89–109, § 2(c), (d)(1), substituted
‘‘against the diseases referred to in subsection (a) of
this section’’ for ‘‘against poliomyelitis, diphtheria,

§ 247b

whooping cough, and tetanus’’, ‘‘of preschool age’’ for
‘‘who are under the age of five years’’ and ‘‘immunization’’ for ‘‘intensive community vaccination’’ in two
places.
Subsec. (c). Pub. L. 89–109, § 2(d)(1), (e), inserted ‘‘on
the basis of estimates’’ and ‘‘(with necessary adjustments on account of underpayments or overpayments)’’
in par. (1), and substituted ‘‘immunization’’ for ‘‘intensive community vaccination’’ in pars. (2) and (3).
EFFECTIVE DATE OF 1978 AMENDMENT
Section 202 of Pub. L. 95–626, as amended by Pub. L.
96–32, § 6(g), July 10, 1979, 93 Stat. 83, provided that the
amendment made by that section is effective Oct. 1,
1978.
EFFECTIVE DATE OF 1976 AMENDMENT
Section 202(a) of Pub. L. 94–317 provided that the
amendment made by that section is effective with respect to grants under this section for fiscal years beginning after June 30, 1975.
EFFECTIVE DATE OF 1975 AMENDMENT
Section 608 of title VI of Pub. L. 94–63 provided that:
‘‘Except as may otherwise be specifically provided, the
amendments made by this title [enacting sections
300c–21 and 300c–22 of this title, amending this section,
and enacting provisions set out as notes under sections
289, 289k–2, and 1395x of this title] and by titles I
[amending section 246 of this title and enacting provisions set out as notes under section 246 of this title], II
[enacting sections 300a–6a and 300a–8 of this title,
amending sections 300 and 300a–1 to 300a–4 of this title,
repealing section 3505c of this title, and enacting provision set out as a note under section 300 of this title], III
[enacting sections 2689 to 2689aa of this title, amending
sections 2691 and 2693 to 2696 of this title, and enacting
provisions set out as notes under section 2689 of this
title], IV [amending sections 218 and 254b of this title
and enacting provision set out as a note under section
254b of this title], and V [enacting section 254c of this
title and amending section 246 of this title] of this Act
shall take effect July 1, 1975. The amendments made by
this title and by such titles to the provisions of law
amended by this title and by such titles are made to
such provisions as amended by title VII of this Act
[amending sections 246, 254b, 300, 300a–1 to 300a–3 of this
title and sections 2681, 2687, 2688a, 2688d, 2688j–1, 2688j–2,
2688l, 2688l–1, 2688n–1, 2688o, and 2688u of this title].’’
EFFECTIVE DATE OF 1972 AMENDMENT
Pub. L. 92–449, title I, § 102, Sept. 30, 1972, 86 Stat. 750,
provided that: ‘‘The amendment made by section 101 of
this title [amending this section] shall apply to grants
made under section 317 of the Public Health Service
Act [this section] after June 30, 1972, except that subsection (d) of such section as amended by section 101
[subsec. (d) of this section] shall take effect on the date
of enactment of this Act [Sept. 30, 1972].’’
RULE OF CONSTRUCTION REGARDING ACCESS TO
IMMUNIZATIONS
Pub. L. 111–148, title IV, § 4204(d), Mar. 23, 2010, 124
Stat. 572, provided that: ‘‘Nothing in this section
[amending this section] (including the amendments
made by this section), or any other provision of this
Act [see Tables for classification] (including any
amendments made by this Act) shall be construed to
decrease children’s access to immunizations.’’
ASSISTANCE OF ADMINISTRATOR OF VETERANS’ AFFAIRS
IN ADMINISTRATION OF NATIONAL SWINE FLU IMMUNIZATION PROGRAM OF 1976; CLAIMS FOR DAMAGES
Pub. L. 94–420, § 3, Sept. 23, 1976, 90 Stat. 1301, provided
that, in order to assist Secretary of Health, Education,
and Welfare in carrying out National Swine Flu Immunization Program of 1976 pursuant to 42 U.S.C. 247b(j),
as added by Pub. L. 94–380, Administrator of Veterans’

§ 247b–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Affairs, in accordance with 42 U.S.C. 247b(j), could authorize administration of vaccine, procured under such
program and provided by Secretary at no cost to Veterans’ Administration, to eligible veterans (voluntarily
requesting such vaccine) in connection with provision
of care for a disability under chapter 17 of title 38, in
any health care facility under jurisdiction of Administrator, and provided for consideration and processing of
claims and suits for damages for personal injury or
death, in connection with administration of vaccine.
STUDY BY SECRETARY OF SCOPE AND EXTENT OF LIABILITY ARISING OUT OF IMMUNIZATION PROGRAM;
ALTERNATIVE PROTECTIVE APPROACHES; REPORT TO
CONGRESS
Section 3 of Pub. L. 94–380 directed Secretary to conduct a study of liability for personal injuries or death
arising out of immunization programs and of alternative approaches to provide protection against such liability and report to Congress on findings of such study
by Aug. 12, 1977.

§ 247b–1. Screenings, referrals, and education regarding lead poisoning
(a) Authority for grants
(1) In general
Subject to paragraph (2), the Secretary, acting through the Director of the Centers for
Disease Control and Prevention, may make
grants to States and political subdivisions of
States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels;
and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood
lead poisoning.
(2) Authority regarding certain entities
With respect to a geographic area with a
need for activities authorized in paragraph (1),
in any case in which neither the State nor the
political subdivision in which such area is located has applied for a grant under paragraph
(1), the Secretary may make a grant under
such paragraph to any grantee under section
254b, 254b, or 256a of this title 1 for carrying
out such activities in the area.
(3) Provision of all services and activities
through each grantee
In making grants under paragraph (1), the
Secretary shall ensure that each of the activities described in such paragraph is provided
through each grantee under such paragraph.
The Secretary may authorize such a grantee
to provide the services and activities directly,
or through arrangements with other providers.
(b) Status as medicaid provider
(1) In general
Subject to paragraph (2), the Secretary may
not make a grant under subsection (a) of this
section unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved
1 See

References in Text notes below.

Page 158

under title XIX of the Social Security Act [42
U.S.C. 1396 et seq.] for the State involved—
(A) the applicant for the grant will provide
the service directly, and the applicant has
entered into a participation agreement
under the State plan and is qualified to receive payments under such plan; or
(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation
agreement and is qualified to receive such
payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of a provider making an
agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding
a participation agreement shall be waived by
the Secretary if the provider does not, in providing health care services, impose a charge or
accept reimbursement available from any
third-party payor, including reimbursement
under any insurance policy or under any Federal or State health benefits plan.
(B) A determination by the Secretary of
whether a provider referred to in subparagraph
(A) meets the criteria for a waiver under such
subparagraph shall be made without regard to
whether the provider accepts voluntary donations regarding the provision of services to the
public.
(c) Priority in making grants
In making grants under subsection (a) of this
section, the Secretary shall give priority to applications for programs that will serve areas
with a high incidence of elevated blood lead levels in infants and children.
(d) Grant application
No grant may be made under subsection (a) of
this section, unless an application therefor has
been submitted to, and approved by, the Secretary. Such an application shall be in such
form and shall be submitted in such manner as
the Secretary shall prescribe and shall include
each of the following:
(1) A complete description of the program
which is to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary
that the program to be provided under the
grant applied for will include educational programs designed to—
(A) communicate to parents, educators,
and local health officials the significance
and prevalence of lead poisoning in infants
and children (including the sources of lead
exposure, the importance of screening young
children for lead, and the preventive steps
that parents can take in reducing the risk of
lead poisoning) which the program is designed to detect and prevent; and
(B) communicate to health professionals
and paraprofessionals updated knowledge
concerning lead poisoning and research (including the health consequences, if any, of
low-level lead burden; the prevalence of lead
poisoning among all socioeconomic group-

Page 159

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ings; the benefits of expanded lead screening;
and the therapeutic and other interventions
available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary
that the applicant will report on a quarterly
basis the number of infants and children
screened for elevated blood lead levels, the
number of infants and children who were found
to have elevated blood lead levels, the number
and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary
that the applicant will make such reports respecting the program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary
that the applicant will coordinate the activities carried out pursuant to subsection (a) of
this section with related activities and services carried out in the State by grantees under
title V or XIX of the Social Security Act [42
U.S.C. 701 et seq., 1396 et seq.].
(6) Assurances satisfactory to the Secretary
that Federal funds made available under such
a grant for any period will be so used as to
supplement and, to the extent practical, increase the level of State, local, and other nonFederal funds that would, in the absence of
such Federal funds, be made available for the
program for which the grant is to be made and
will in no event supplant such State, local,
and other non-Federal funds.
(7) Assurances satisfactory to the Secretary
that the applicant will ensure complete and
consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in
accordance with guidelines of the Centers for
Disease Control and Prevention for standardized reporting as described in subsection (m) of
this section.
(8) Such other information as the Secretary
may prescribe.
(e) Relationship to services and activities under
other programs
(1) In general
A recipient of a grant under subsection (a) of
this section may not make payments from the
grant for any service or activity to the extent
that payment has been made, or can reasonably be expected to be made, with respect to
such service or activity—
(A) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
Paragraph (1) shall not apply in the case of
a provider through which a grantee under subsection (a) of this section provides services
under such subsection if the Secretary has
provided a waiver under subsection (b)(2) of
this section regarding the provider.

§ 247b–1

(f) Method and amount of payment
The Secretary shall determine the amount of
a grant made under subsection (a) of this section. Payments under such grants may be made
in advance on the basis of estimates or by way
of reimbursement, with necessary adjustments
on account of underpayments or overpayments,
and in such installments and on such terms and
conditions as the Secretary finds necessary to
carry out the purposes of such grants. Not more
than 10 percent of any grant may be obligated
for administrative costs.
(g) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of
a grant under subsection (a) of this section, may
reduce the amount of such grant by—
(1) the fair market value of any supplies or
equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and
travel expenses of any officer or employee of
the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such
officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee
is for the convenience of and at the request of
such grant recipient and for the purpose of carrying out a program with respect to which the
grant under subsection (a) of this section is
made. The amount by which any such grant is so
reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the
supplies or equipment, or in detailing the personnel, on which the reduction of such grant is
based, and such amount shall be deemed as part
of the grant and shall be deemed to have been
paid to the grant recipient.
(h) Records
Each recipient of a grant under subsection (a)
of this section shall keep such records as the
Secretary shall prescribe, including records
which fully disclose the amount and disposition
by such recipient of the proceeds of such grant,
the total cost of the undertaking in connection
with which such grant was made, and the
amount of that portion of the cost of the undertaking supplied by other sources, and such other
records as will facilitate an effective audit.
(i) Audit and examination of records
The Secretary and the Comptroller General of
the United States, or any of their duly authorized representatives, shall have access for the
purpose of audit and examination to any books,
documents, papers, and records of the recipient
of a grant under subsection (a) of this section,
that are pertinent to such grant.
(j) Annual report
(1) In general
Not later than May 1 of each year, the Secretary shall submit to the Congress a report
on the effectiveness during the preceding fiscal year of programs carried out with grants
under subsection (a) of this section and of any
programs that are carried out by the Secretary pursuant to subsection (l)(2) of this section.

§ 247b–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Certain requirements
Each report under paragraph (1) shall include, in addition to any other information
that the Secretary may require, the following
information:
(A) The number of infants and children
screened.
(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of
such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the blood lead levels of the infants
and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and
local health departments.
(G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with
the equivalent data, if any, provided in the
report under paragraph (1) preceding the report involved.
(k) Indian tribes
For purposes of this section, the term ‘‘political subdivision’’ includes Indian tribes.
(l) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$40,000,000 for fiscal year 1993, and such sums
as may be necessary for each of the fiscal
years 1994 through 2005.
(2) Allocation for other programs
Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary
may reserve not more than 20 percent for carrying out programs regarding the activities
described in subsection (a) of this section in
addition to the program of grants established
in such subsection.
(m) Guidelines for standardized reporting
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall develop national guidelines for the uniform
reporting of all blood lead test results to State
and local health departments.
(July 1, 1944, ch. 373, title III, § 317A, as added
Pub. L. 100–572, § 3, Oct. 31, 1988, 102 Stat. 2887;
amended Pub. L. 102–531, title III, § 303(a), Oct.
27, 1992, 106 Stat. 3484; Pub. L. 103–183, title VII,
§ 705(a), Dec. 14, 1993, 107 Stat. 2241; Pub. L.
105–392, title IV, § 404, Nov. 13, 1998, 112 Stat. 3588;
Pub. L. 106–310, div. A, title XXV, §§ 2501(a), (b),
2504, Oct. 17, 2000, 114 Stat. 1161, 1164; Pub. L.
107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117
Stat. 2023.)
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing, referred to in subsec. (a)(2), was in the

Page 160

original a reference to section 329, meaning section 329
of act July 1, 1944, which was omitted in the general
amendment of subpart I (§ 254b et seq.) of part D of this
subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat.
3626.
Section 256a of this title, referred to in subsec. (a)(2),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.
The Social Security Act, referred to in subsecs. (b)(1)
and (d)(5), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles V and XIX of the Act are classified
generally to subchapters V (§ 701 et seq.) and XIX (§ 1396
et seq.), respectively, of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 247b–1, Pub. L. 95–626, title IV, § 401,
Nov. 10, 1978, 92 Stat. 3590; S. Res. 30, Mar. 7, 1979; Pub.
L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; H.
Res. 549, Mar. 25, 1980, related to demonstration and
evaluation of optimal methods for organizing and delivering comprehensive preventive health services to defined populations, prior to repeal by Pub. L. 97–35, title
IX, § 902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561, eff. Oct.
1, 1981.
AMENDMENTS
2003—Subsec. (a)(2). Pub. L. 108–163 substituted ‘‘254b’’
for ‘‘254c, 254b(h)’’ before ‘‘, or’’.
2002—Subsec. (a)(2). Pub. L. 107–251 substituted
‘‘254b(h)’’ for ‘‘256’’.
2000—Subsec. (d)(7), (8). Pub. L. 106–310, § 2501(a)(1),
added par. (7) and redesignated former par. (7) as (8).
Subsec. (j)(2)(F), (G). Pub. L. 106–310, § 2501(a)(2),
added subpar. (F), redesignated former subpar. (F) as
(G), and substituted ‘‘(F)’’ for ‘‘(E)’’.
Subsec. (l)(1). Pub. L. 106–310, § 2504, substituted ‘‘1994
through 2005’’ for ‘‘1994 through 2002’’.
Subsec. (m). Pub. L. 106–310, § 2501(b), added subsec.
(m).
1998—Subsec. (l)(1). Pub. L. 105–392 substituted ‘‘2002’’
for ‘‘1998’’.
1993—Subsec. (l)(1). Pub. L. 103–183 substituted
‘‘through 1998’’ for ‘‘through 1997’’.
1992—Pub. L. 102–531 amended section generally, substituting present provisions for provisions relating to
grants to States for lead poisoning prevention, grant
applications, conditions for approval, method and
amount of payment, reduction of amount, recordkeeping and audits, inclusion of Indian tribes as grant
recipients, and authorization of appropriations.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
DEVELOPMENT AND IMPLEMENTATION OF EFFECTIVE
DATA MANAGEMENT BY THE CENTERS FOR DISEASE
CONTROL AND PREVENTION
Pub. L. 106–310, div. A, title XXV, § 2501(c), Oct. 17,
2000, 114 Stat. 1161, provided that:
‘‘(1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention shall—
‘‘(A) assist with the improvement of data linkages
between State and local health departments and between State health departments and the Centers for
Disease Control and Prevention;
‘‘(B) assist States with the development of flexible,
comprehensive State-based data management systems for the surveillance of children with lead poisoning that have the capacity to contribute to a national data set;
‘‘(C) assist with the improvement of the ability of
State-based data management systems and federallyfunded means-tested public benefit programs (including the special supplemental food program for

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

women, infants and children (WIC) under section 17 of
the Child Nutrition Act of 1966 (42 U.S.C. 1786) and the
early head start program under section 645A of the
Head Start Act (42 U.S.C. 9840a(h)) to respond to ad
hoc inquiries and generate progress reports regarding
the lead blood level screening of children enrolled in
those programs;
‘‘(D) assist States with the establishment of a capacity for assessing how many children enrolled in
the Medicaid, WIC, early head start, and other federally-funded means-tested public benefit programs are
being screened for lead poisoning at age-appropriate
intervals;
‘‘(E) use data obtained as result of activities under
this section to formulate or revise existing lead blood
screening and case management policies; and
‘‘(F) establish performance measures for evaluating
State and local implementation of the requirements
and improvements described in subparagraphs (A)
through (E).
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this subsection such sums as may be necessary for each [sic]
the fiscal years 2001 through 2005.
‘‘(3) EFFECTIVE DATE.—This subsection takes effect on
the date of the enactment of this Act [Oct. 17, 2000].’’

§ 247b–2. Repealed. Pub. L. 97–35,
§ 902(a), Aug. 13, 1981, 95 Stat. 559
Section, Pub. L.
Stat. 3591; Pub. L.
Stat. 695, related
holic beverage use

title

IX,

95–626, title IV, § 402, Nov. 10, 1978, 92
96–88, title V, § 509(b), Oct. 17, 1979, 93
to deterrence of smoking and alcoamong children and adolescents.

EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1981, see section 902(h) of Pub.
L. 97–35, set out as an Effective Date of 1981 Amendment note under section 300aaa–12 of this title.

§ 247b–3. Education, technology assessment, and
epidemiology regarding lead poisoning
(a) Prevention
(1) Public education
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall carry out a program to educate
health professionals and paraprofessionals and
the general public on the prevention of lead
poisoning in infants and children. In carrying
out the program, the Secretary shall make
available information concerning the health
effects of low-level lead toxicity, the causes of
lead poisoning, and the primary and secondary
preventive measures that may be taken to prevent such poisoning.
(2) Interagency Task Force
(A) Not later than 6 months after October 27,
1992, the Secretary shall establish a council to
be known as the Interagency Task Force on
the Prevention of Lead Poisoning (in this
paragraph referred to as the ‘‘Task Force’’).
The Task Force shall coordinate the efforts of
Federal agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the
chair of the Task Force;
(ii) the Secretary of Housing and Urban
Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials
specified in clauses (i) through (iii), as selected by the officials respectively.

§ 247b–3

(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the
officials serving as members of the Task
Force, including—
(I) the plan of the Secretary of Health
and Human Services entitled ‘‘Strategic
Plan for the Elimination of Lead Poisoning’’, dated February 21, 1991;
(II) the plan of the Secretary of Housing
and Urban Development entitled ‘‘Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately
Owned Housing’’, dated December 7, 1990;
and
(III) the strategy of the Administrator of
the Environmental Protection Agency entitled ‘‘Strategy for Reducing Lead Exposures’’, dated February 21, 1991;
(ii) develop a unified implementation plan
for programs that receive Federal financial
assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and
disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of
research and education concerning lead poisoning;
(v) identify the practical and technological
constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive
review of Federal programs providing assistance to prevent lead poisoning, and not later
than May 1 of each year, submit to the Committee on Labor and Human Resources of
the Senate and the Committee on the Environment and Public Works of the Senate,
and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a
result of such review and that contains the
recommendations of the Task Force on the
programs and policies with respect to which
the Task Force is established, including related budgetary recommendations; and
(vii) annually review and coordinate departmental and agency budgetary requests
with respect to all lead poisoning prevention
activities of the Federal Government.
(b) Technology assessment and epidemiology
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall, directly or through grants or contracts—
(1) provide for the development of improved,
more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved
methods of assessing the prevalence of lead
poisoning, including such methods as may be
necessary to conduct individual assessments
for each State;
(3) provide for the collection of data on the
incidence and prevalence of lead poisoning of
infants and children, on the demographic characteristics of infants and children with such
poisoning (including racial and ethnic status),
and on the source of payment for treatment
for such poisoning (including the extent to

§ 247b–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

which insurance has paid for such treatment);
and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in
infants and children.
(July 1, 1944, ch. 373, title III, § 317B, as added
Pub. L. 102–531, title III, § 303(b), Oct. 27, 1992, 106
Stat. 3488; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(i), June 10, 1993, 107 Stat. 212.)
AMENDMENTS
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 303(b), which enacted this section.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 247b–3a. Training and reports by the Health Resources and Services Administration
(a) Training
The Secretary of Health and Human Services,
acting through the Administrator of the Health
Resources and Services Administration and in
collaboration with the Administrator of the
Centers for Medicare & Medicaid Services and
the Director of the Centers for Disease Control
and Prevention, shall conduct education and
training programs for physicians and other
health care providers regarding childhood lead
poisoning, current screening and treatment recommendations and requirements, and the scientific, medical, and public health basis for
those policies.
(b) Report
The Secretary of Health and Human Services,
acting through the Administrator of the Health
Resources and Services Administration, annually shall report to Congress on the number of
children who received services through health
centers established under section 254b of this
title and received a blood lead screening test
during the prior fiscal year, noting the percentage that such children represent as compared to
all children who received services through such
health centers.
(c) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each 1 the fiscal years 2001 through
2005.
(Pub. L. 106–310, div. A, title XXV, § 2503, Oct. 17,
2000, 114 Stat. 1163; Pub. L. 108–173, title IX,
§ 900(e)(6)(E), Dec. 8, 2003, 117 Stat. 2374.)
1 So

in original. Probably should be followed by ‘‘of’’.

Page 162

CODIFICATION
Section was enacted as part of the Children’s Health
Act of 2000, and not as part of the Public Health Service
Act which comprises this chapter.
AMENDMENTS
2003—Subsec. (a). Pub. L. 108–173 substituted ‘‘Centers
for Medicare & Medicaid Services’’ for ‘‘Health Care Financing Administration’’.

§ 247b–4. National Center on Birth Defects and
Developmental Disabilities
(a) In general
(1) National Center
There is established within the Centers for
Disease Control and Prevention a center to be
known as the National Center on Birth Defects
and Developmental Disabilities (referred to in
this section as the ‘‘Center’’), which shall be
headed by a director appointed by the Director
of the Centers for Disease Control and Prevention.
(2) General duties
The Secretary shall carry out programs—
(A) to collect, analyze, and make available
data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2) of this section), including data
on the causes of such defects and disabilities
and on the incidence and prevalence of such
defects and disabilities;
(B) to operate regional centers for the conduct of applied epidemiological research on
the prevention of such defects and disabilities;
(C) to provide information and education
to the public on the prevention of such defects and disabilities;
(D) to conduct research on and to promote
the prevention of such defects and disabilities, and secondary health conditions
among individuals with disabilities; and
(E) to support a National Spina Bifida Program to prevent and reduce suffering from
the Nation’s most common permanently disabling birth defect.
(3) Folic acid
The Secretary shall carry out section 247b–11
of this title through the Center.
(4) Certain programs
(A) Transfers
All programs and functions described in
subparagraph (B) are transferred to the Center, effective upon the expiration of the 180day period beginning on October 17, 2000.
(B) Relevant programs
The programs and functions described in
this subparagraph are all programs and functions that—
(i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child
development; newborn screening; autism;
fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases,
disorders, or conditions as determined 1 the
Secretary; and
1 So

in original. Probably should be followed by the word ‘‘by’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) were carried out through the National Center for Environmental Health as
of the day before October 17, 2000.
(C) Related transfers
Personnel employed in connection with
the programs and functions specified in subparagraph (B), and amounts available for
carrying out the programs and functions, are
transferred to the Center, effective upon the
expiration of the 180-day period beginning on
October 17, 2000. Such transfer of amounts
does not affect the period of availability of
the amounts, or the availability of the
amounts with respect to the purposes for
which the amounts may be expended.
(b) Grants and contracts
(1) In general
In carrying out subsection (a) of this section, the Secretary may make grants to and
enter into contracts with public and nonprofit
private entities.
(2) Supplies and services in lieu of award
funds
(A) Upon the request of a recipient of an
award of a grant or contract under paragraph
(1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and
services for the purpose of aiding the recipient
in carrying out the purposes for which the
award is made and, for such purposes, may detail to the recipient any officer or employee of
the Department of Health and Human Services.
(B) With respect to a request described in
subparagraph (A), the Secretary shall reduce
the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of
any supplies, equipment, or services provided
by the Secretary. The Secretary shall, for the
payment of expenses incurred in complying
with such request, expend the amounts withheld.
(3) Application for award
The Secretary may make an award of a
grant or contract under paragraph (1) only if
an application for the award is submitted to
the Secretary and the application is in such
form, is made in such manner, and contains
such agreements, assurances, and information
as the Secretary determines to be necessary to
carry out the purposes for which the award is
to be made.
(c) Biennial report
Not later than February 1 of fiscal year 1999
and of every second such year thereafter, the
Secretary shall submit to the Committee on
Commerce of the House of Representatives, and
the Committee on Labor and Human Resources
of the Senate, a report that, with respect to the
preceding 2 fiscal years—
(1) contains information regarding the incidence and prevalence of birth defects, developmental disabilities, and the health status of
individuals with disabilities and the extent to
which these conditions have contributed to
the incidence and prevalence of infant mortality and affected quality of life;

§ 247b–4

(2) contains information under paragraph (1)
that is specific to various racial and ethnic
groups (including Hispanics, non-Hispanic
whites, Blacks, Native Americans, and Asian
Americans);
(3) contains an assessment of the extent to
which various approaches of preventing birth
defects, developmental disabilities, and secondary health conditions among individuals
with disabilities have been effective;
(4) describes the activities carried out under
this section;
(5) contains information on the incidence
and prevalence of individuals living with birth
defects and disabilities or developmental disabilities, information on the health status of
individuals with disabilities, information on
any health disparities experienced by such individuals, and recommendations for improving
the health and wellness and quality of life of
such individuals;
(6) contains a summary of recommendations
from all birth defects research conferences
sponsored by the Centers for Disease Control
and Prevention, including conferences related
to spina bifida; and
(7) contains any recommendations of the
Secretary regarding this section.
(d) Applicability of privacy laws
The provisions of this section shall be subject
to the requirements of section 552a of title 5. All
Federal laws relating to the privacy of information shall apply to the data and information
that is collected under this section.
(e) Advisory committee
Notwithstanding any other provision of law,
the members of the advisory committee appointed by the Director of the National Center
for Environmental Health that have expertise in
birth defects, developmental disabilities, and
disabilities and health shall be transferred to
and shall advise the National Center on Birth
Defects and Developmental Disabilities effective
on December 3, 2003.
(f) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2003 through 2007.
(July 1, 1944, ch. 373, title III, § 317C, as added
Pub. L. 102–531, title III, § 306(a), Oct. 27, 1992, 106
Stat. 3494; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(iii), June 10, 1993, 107 Stat. 213;
Pub. L. 105–168, § 2, Apr. 21, 1998, 112 Stat. 43;
Pub. L. 106–310, div. A, title VI, § 611, Oct. 17,
2000, 114 Stat. 1119; Pub. L. 108–154, § 2, Dec. 3,
2003, 117 Stat. 1933; Pub. L. 111–256, § 2(f)(1), Oct.
5, 2010, 124 Stat. 2644.)
AMENDMENTS
2010—Subsec. (a)(4)(B)(i). Pub. L. 111–256 substituted
‘‘intellectual disabilities;’’ for ‘‘mental retardation;’’.
2003—Subsec. (a)(2)(A). Pub. L. 108–154, § 2(1)(A), substituted ‘‘, developmental disabilities, and disabilities
and health’’ for ‘‘and developmental disabilities’’ and
‘‘subsection (c)(2)’’ for ‘‘subsection (d)(2)’’.
Subsec. (a)(2)(D), (E). Pub. L. 108–154, § 2(1)(B)–(D),
added subpars. (D) and (E).
Subsecs. (b), (c). Pub. L. 108–154, § 2(2),(4), redesignated subsecs. (c) and (d) as (b) and (c), respectively,

§ 247b–4a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and struck out former subsec. (b) which related to additional provisions regarding collection of data.
Subsec. (d). Pub. L. 108–154, § 2(4), redesignated subsec.
(e) as (d). Former subsec. (d) redesignated (c).
Subsec. (d)(1). Pub. L. 108–154, § 2(3)(A), added par. (1)
and struck out former par. (1) which read as follows:
‘‘contains information regarding the incidence and
prevalence of birth defects and the extent to which
birth defects have contributed to the incidence and
prevalence of infant mortality;’’.
Subsec. (d)(3). Pub. L. 108–154, § 2(3)(B), inserted
‘‘, developmental disabilities, and secondary health
conditions among individuals with disabilities’’ after
‘‘defects’’.
Subsec. (d)(5) to (7). Pub. L. 108–154, § 2(3)(C)–(E),
added pars. (5) and (6) and redesignated former par. (5)
as (7).
Subsec. (e). Pub. L. 108–154, § 2(5), added subsec. (e).
Former subsec. (e) redesignated (d).
Subsec. (f). Pub. L. 108–154, § 2(6) substituted ‘‘such
sums as may be necessary for each of fiscal years 2003
through 2007.’’ for ‘‘$30,000,000 for fiscal year 1999,
$40,000,000 for fiscal year 2000, and such sums as may be
necessary for each of the fiscal years 2001 and 2002.’’
2000—Pub. L. 106–310, § 611(1), substituted ‘‘National
Center on Birth Defects and Developmental Disabilities’’ for ‘‘Programs regarding birth defects’’ in section catchline.
Subsec. (a). Pub. L. 106–310, § 611(2), added subsec. (a)
and struck out heading and text of former subsec. (a)
relating to Secretary’s responsibility, acting through
the Centers for Disease Control and Prevention, to
carry out programs regarding birth defects.
Subsec. (b)(1). Pub. L. 106–310, § 611(3), substituted
‘‘subsection (a)(2)(A) of this section’’ for ‘‘subsection
(a)(1) of this section’’ in introductory provisions.
1998—Pub. L. 105–168 amended section generally, substituting present provisions for provisions which directed Secretary to encourage and assist States in collection and analysis of epidemiological data on birth
defects and to establish and maintain National Information Clearinghouse on Birth Defects, required report
not later than July 1, 1993, and biennially thereafter,
and authorized appropriations for fiscal years 1993, 1994,
and 1995.
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 306(a), which enacted this section.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
CONGRESSIONAL FINDINGS
Pub. L. 105–168, § 1(b), Apr. 21, 1998, 112 Stat. 43, provided that: ‘‘Congress makes the following findings:
‘‘(1) Birth defects are the leading cause of infant
mortality, directly responsible for one out of every
five infant deaths.
‘‘(2) Thousands of the 150,000 infants born with a serious birth defect annually face a lifetime of chronic
disability and illness.
‘‘(3) Birth defects threaten the lives of infants of all
racial and ethnic backgrounds. However, some conditions pose excess risks for certain populations. For
example, compared to all infants born in the United
States, Hispanic-American infants are more likely to
be born with anencephaly spina bifida and other neural tube defects and African-American infants are
more likely to be born with sickle-cell anemia.

Page 164

‘‘(4) Birth defects can be caused by exposure to environmental hazards, adverse health conditions during pregnancy, or genetic mutations. Prevention efforts are slowed by lack of information about the
number and causes of birth defects. Outbreaks of
birth defects may go undetected because surveillance
and research efforts are underdeveloped and poorly
coordinated.
‘‘(5) Public awareness strategies, such as programs
using folic acid vitamin supplements to prevent spina
bifida and alcohol avoidance programs to prevent
Fetal Alcohol Syndrome, are essential to prevent the
heartache and costs associated with birth defects.’’
DEFINITIONS
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss
(a) Definitions
For the purposes of this section only, the following terms in this section are defined as follows:
(1) Hearing screening
Newborn and infant hearing screening consists of objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.
(2) Audiologic evaluation
Audiologic evaluation consists of procedures
to assess the status of the auditory system; to
establish the site of the auditory disorder; the
type and degree of hearing loss, and the potential effects of hearing loss on communication;
and to identify appropriate treatment and referral options. Referral options should include
linkage to State IDEA part C coordinating
agencies or other appropriate agencies, medical evaluation, hearing aid/sensory aid assessment, audiologic rehabilitation treatment, national and local consumer, self-help, parent,
and education organizations, and other family-centered services.
(3) Medical evaluation
Medical evaluation by a physician consists
of key components including history, examination, and medical decision making focused
on symptomatic and related body systems for
the purpose of diagnosing the etiology of hearing loss and related physical conditions, and
for identifying appropriate treatment and referral options.
(4) Medical intervention
Medical intervention is the process by which
a physician provides medical diagnosis and direction for medical and/or surgical treatment
options of hearing loss and/or related medical
disorder associated with hearing loss.
(5) Audiologic rehabilitation
Audiologic rehabilitation (intervention) consists of procedures, techniques, and technologies to facilitate the receptive and expres-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

sive communication abilities of a child with
hearing loss.
(6) Early intervention
Early intervention (e.g., nonmedical) means
providing appropriate services for the child
with hearing loss and ensuring that families of
the child are provided comprehensive, consumer-oriented information about the full
range of family support, training, information
services, communication options and are given
the opportunity to consider the full range of
educational and program placements and options for their child.
(b) Purposes
The purposes of this section are to clarify the
authority within the Public Health Service Act
[42 U.S.C. 201 et seq.] to authorize statewide
newborn and infant hearing screening, evaluation and intervention programs and systems,
technical assistance, a national applied research
program, and interagency and private sector
collaboration for policy development, in order to
assist the States in making progress toward the
following goals:
(1) All babies born in hospitals in the United
States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or
adoption should have a hearing screening as
early as possible.
(2) All babies who are not born in hospitals
in the United States and its territories should
have a hearing screening within the first 3
months of life.
(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for
all newborns and infants suspected of having
hearing loss to allow appropriate referral and
provisions for audiologic rehabilitation, medical and early intervention before the age of 6
months.
(4) All newborn and infant hearing screening
programs and systems should include a component for audiologic rehabilitation, medical and
early intervention options that ensures linkage to any new and existing statewide systems
of intervention and rehabilitative services for
newborns and infants with hearing loss.
(5) Public policy in regard to newborn and
infant hearing screening and intervention
should be based on applied research and the
recognition that newborns, infants, toddlers,
and children who are deaf or hard-of-hearing
have unique language, learning, and communication needs, and should be the result of
consultation with pertinent public and private
sectors.
(c) Statewide newborn and infant hearing
screening, evaluation and intervention programs and systems
Under the existing authority of the Public
Health Service Act [42 U.S.C. 201 et seq.], the
Secretary of Health and Human Services (in this
section referred to as the ‘‘Secretary’’), acting
through the Administrator of the Health Resources and Services Administration, shall
make awards of grants or cooperative agreements to develop statewide newborn and infant

§ 247b–4a

hearing screening, evaluation and intervention
programs and systems for the following purposes:
(1) To develop and monitor the efficacy of
statewide newborn and infant hearing screening, evaluation and intervention programs and
systems. Early intervention includes referral
to schools and agencies, including community,
consumer, and parent-based agencies and organizations and other programs mandated by
part C of the Individuals with Disabilities
Education Act [20 U.S.C. 1431 et seq.], which
offer programs specifically designed to meet
the unique language and communication needs
of deaf and hard-of-hearing newborns, infants,
toddlers, and children.
(2) To collect data on statewide newborn and
infant hearing screening, evaluation and intervention programs and systems that can be
used for applied research, program evaluation
and policy development.
(d) Technical assistance, data management, and
applied research
(1) Centers for Disease Control and Prevention
Under the existing authority of the Public
Health Service Act [42 U.S.C. 201 et seq.], the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention,
shall make awards of grants or cooperative
agreements to provide technical assistance to
State agencies to complement an intramural
program and to conduct applied research related to newborn and infant hearing screening,
evaluation and intervention programs and systems. The program shall develop standardized
procedures for data management and program
effectiveness and costs, such as—
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;
(B) to provide technical assistance on data
collection and management;
(C) to study the costs and effectiveness of
newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in
order to answer issues of importance to
State and national policymakers;
(D) to identify the causes and risk factors
for congenital hearing loss;
(E) to study the effectiveness of newborn
and infant hearing screening, audiologic and
medical evaluations and intervention programs and systems by assessing the health,
intellectual and social developmental, cognitive, and language status of these children
at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth
defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing
loss.
(2) National Institutes of Health
Under the existing authority of the Public
Health Service Act, the Director of the National Institutes of Health, acting through the
Director of the National Institute on Deafness

§ 247b–4a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and Other Communication Disorders, shall for
purposes of this section, continue a program of
research and development on the efficacy of
new screening techniques and technology, including clinical studies of screening methods,
studies on efficacy of intervention, and related
research.
(e) Coordination and collaboration
(1) In general
Under the existing authority of the Public
Health Service Act [42 U.S.C. 201 et seq.], in
carrying out programs under this section, the
Administrator of the Health Resources and
Services Administration, the Director of the
Centers for Disease Control and Prevention,
and the Director of the National Institutes of
Health shall collaborate and consult with
other Federal agencies; State and local agencies, including those responsible for early
intervention services pursuant to title XIX of
the Social Security Act [42 U.S.C. 1396 et seq.]
(Medicaid Early and Periodic Screening, Diagnosis and Treatment Program); title XXI of
the Social Security Act [42 U.S.C. 1397aa et
seq.], (State Children’s Health Insurance Program); title V of the Social Security Act [42
U.S.C. 701 et seq.] (Maternal and Child Health
Block Grant Program); and part C of the Individuals with Disabilities Education Act [20
U.S.C. 1431 et seq.]; consumer groups of and
that serve individuals who are deaf and hardof-hearing and their families; appropriate national medical and other health and education
specialty organizations; persons who are deaf
and hard-of-hearing and their families; other
qualified professional personnel who are proficient in deaf or hard-of-hearing children’s
language and who possess the specialized
knowledge, skills, and attributes needed to
serve deaf and hard-of-hearing newborns, infants, toddlers, children, and their families;
third-party payers and managed care organizations; and related commercial industries.
(2) Policy development
Under the existing authority of the Public
Health Service Act, the Administrator of the
Health Resources and Services Administration, the Director of the Centers for Disease
Control and Prevention, and the Director of
the National Institutes of Health shall coordinate and collaborate on recommendations for
policy development at the Federal and State
levels and with the private sector, including
consumer, medical and other health and education professional-based organizations, with
respect to newborn and infant hearing screening, evaluation and intervention programs and
systems.
(3) State early detection, diagnosis, and intervention programs and systems; data collection
Under the existing authority of the Public
Health Service Act, the Administrator of the
Health Resources and Services Administration
and the Director of the Centers for Disease
Control and Prevention shall coordinate and
collaborate in assisting States to establish
newborn and infant hearing screening, evaluation and intervention programs and systems

Page 166

under subsection (c) of this section and to develop a data collection system under subsection (d) of this section.
(f) Rule of construction
Nothing in this section shall be construed to
preempt any State law.
(g) Authorization of appropriations
(1) Statewide newborn and infant hearing
screening, evaluation and intervention programs and systems
For the purpose of carrying out subsection
(c) of this section under the existing authority
of the Public Health Service Act [42 U.S.C. 201
et seq.], there are authorized to the Health Resources and Services Administration appropriations in the amount of $5,000,000 for fiscal
year 2000, $8,000,000 for fiscal year 2001, and
such sums as may be necessary for fiscal year
2002.
(2) Technical assistance, data management,
and applied research; Centers for Disease
Control and Prevention
For the purpose of carrying out subsection
(d)(1) of this section under the existing authority of the Public Health Service Act, there are
authorized to the Centers for Disease Control
and Prevention, appropriations in the amount
of $5,000,000 for fiscal year 2000, $7,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal year 2002.
(3) Technical assistance, data management,
and applied research; National Institute on
Deafness and Other Communication Disorders
For the purpose of carrying out subsection
(d)(2) of this section under the existing authority of the Public Health Service Act, there are
authorized to the National Institute on Deafness and Other Communication Disorders appropriations for such sums as may be necessary for each of the fiscal years 2000 through
2002.
(Pub. L. 106–113, div. B, § 1000(a)(4) [title VI,
§ 601], Nov. 29, 1999, 113 Stat. 1535, 1501A–276.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsecs.
(b) to (e) and (g), is act July 1, 1944, ch. 373, 58 Stat. 682,
as amended, which is classified generally to this chapter (§ 201 et seq.). For complete classification of this
Act to the Code, see Short Title note set out under section 201 of this title and Tables.
The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1) and (e)(1), is title VI of Pub.
L. 91–230, Apr. 13, 1970, 84 Stat. 175, as amended. Part C
of the Act is classified generally to subchapter III
(§ 1431 et seq.) of chapter 33 of Title 20, Education. For
complete classification of this Act to the Code, see section 1400 of Title 20 and Tables.
The Social Security Act, referred to in subsec. (e)(1),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Titles V, XIX, and XXI of the Act are classified generally to subchapters V (§ 701 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of
this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
CODIFICATION
Section was enacted as part of the Departments of
Labor, Health, and Human Services, and Education,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and Related Agencies Appropriations Act, 2000, and not
as part of the Public Health Service Act which comprises this chapter.

§§ 247b–4b to 247b–4d. Repealed. Pub. L. 109–416,
§ 3(b)(1)–(3), Dec. 19, 2006, 120 Stat. 2829
Section 247b–4b, Pub. L. 106–310, div. A, title I, § 102,
Oct. 17, 2000, 114 Stat. 1107, related to developmental
disabilities surveillance and research programs.
Section 247b–4c, Pub. L. 106–310, div. A, title I, § 103,
Oct. 17, 2000, 114 Stat. 1108, related to information and
education.
Section 247b–4d, Pub. L. 106–310, div. A, title I, § 104,
Oct. 17, 2000, 114 Stat. 1109, related to Inter-agency Autism Coordinating Committee.

§ 247b–4e. Repealed. Pub. L. 109–416, § 3(b)(4),
Dec. 19, 2006, 120 Stat. 2829; Pub. L. 109–482,
title I, § 104(b)(3)(D), Jan. 15, 2007, 120 Stat.
3694
Section, Pub. L. 106–310, div. A, title I, § 105, Oct. 17,
2000, 114 Stat. 1109, related to annual report to Congress
concerning the implementation of this section and sections 247b–4b to 247b–4d and 284g of this title.
EFFECTIVE DATE OF REPEAL
Repeal by Pub. L. 109–482 applicable only with respect
to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set
out as an Effective Date of 2007 Amendment note under
section 281 of this title.

§ 247b–4f. Research relating to preterm labor and
delivery and the care, treatment, and outcomes of preterm and low birthweight infants
(a) Omitted
(b) Studies on relationship between prematurity
and birth defects
(1) In general
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall,
subject to the availability of appropriations,
conduct ongoing epidemiological studies on
the relationship between prematurity, birth
defects, and developmental disabilities.
(2) Report
Not later than 2 years after December 22,
2006, and every 2 years thereafter, the Secretary of Health and Human Services, acting
through the Director of the Centers for Disease Control and Prevention, shall submit to
the appropriate committees of Congress reports concerning the progress and any results
of studies conducted under paragraph (1).
(c) Pregnancy risk assessment monitoring survey
(1) In general
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall
establish systems for the collection of maternal-infant clinical and biomedical information, including electronic health records, electronic databases, and biobanks, to link with
the Pregnancy Risk Assessment Monitoring
System (PRAMS) and other epidemiological
studies of prematurity in order to track pregnancy outcomes and prevent preterm birth.

§ 247b–4g

(2) Authorization of appropriations
There is authorized to be appropriated to
carry out paragraph (1) $3,000,000 for each of
fiscal years 2007 through 2011.
(d) Evaluation of existing tools and measures
The Secretary of Health and Human Services
shall review existing tools and measures to ensure that such tools and measures include information related to the known risk factors of low
birth weight and preterm birth.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, except for subsection (c),
$5,000,000 for each of fiscal years 2007 through
2011.
(Pub. L. 109–450, § 3, Dec. 22, 2006, 120 Stat. 3341.)
CODIFICATION
Section is comprised of section 3 of Pub. L. 109–450.
Subsec. (a) of section 3 of Pub. L. 109–450 amended section 241 of this title.
Section was enacted as part of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or the PREEMIE Act, and not
as part of the Public Health Service Act which comprises this chapter.
PURPOSE
Pub. L. 109–450, § 2, Dec. 22, 2006, 120 Stat. 3341, provided that: ‘‘It is the purpose of this Act [enacting this
section and sections 247b–4g and 280g–5 of this title and
amending sections 241 and 280g–4 of this title] to—
‘‘(1) reduce rates of preterm labor and delivery;
‘‘(2) work toward an evidence-based standard of
care for pregnant women at risk of preterm labor or
other serious complications, and for infants born
preterm and at a low birthweight; and
‘‘(3) reduce infant mortality and disabilities caused
by prematurity.’’

§ 247b–4g. Interagency Coordinating Council on
Prematurity and Low Birthweight
(a) Purpose
It is the purpose of this section to stimulate
multidisciplinary research, scientific exchange,
and collaboration among the agencies of the Department of Health and Human Services and to
assist the Department in targeting efforts to
achieve the greatest advances toward the goal of
reducing prematurity and low birthweight.
(b) Establishment
The Secretary of Health and Human Services
shall establish an Interagency Coordinating
Council on Prematurity and Low Birthweight
(referred to in this section as the Council) to
carry out the purpose of this section.
(c) Composition
The Council shall be composed of members to
be appointed by the Secretary, including representatives of the agencies of the Department
of Health and Human Services.
(d) Activities
The Council shall—
(1) annually report to the Secretary of
Health and Human Services and Congress on
current Departmental activities relating to
prematurity and low birthweight;
(2) carry out other activities determined appropriate by the Secretary of Health and
Human Services; and

§ 247b–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) oversee the coordination of the implementation of this Act.
(Pub. L. 109–450, § 5, Dec. 22, 2006, 120 Stat. 3343.)
REFERENCES IN TEXT
This Act, referred to in subsec. (d)(3), is Pub. L.
109–450, Dec. 22, 2006, 120 Stat. 3341, known as the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act and also as the
PREEMIE Act. For complete classification of this Act
to the Code, see Short Title of 2006 Amendment note
set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or the PREEMIE Act, and not
as part of the Public Health Service Act which comprises this chapter.

§ 247b–5. Preventive health measures with respect to prostate cancer
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to States and local health departments for the purpose of enabling such
States and departments to carry out programs
that may include the following:
(1) To identify factors that influence the attitudes or levels of awareness of men and
health care practitioners regarding screening
for prostate cancer.
(2) To evaluate, in consultation with the
Agency for Health Care Policy and Research
and the National Institutes of Health, the effectiveness of screening strategies for prostate
cancer.
(3) To identify, in consultation with the
Agency for Health Care Policy and Research,
issues related to the quality of life for men
after prostrate 1 cancer screening and followup.
(4) To develop and disseminate public information and education programs for prostate
cancer, including appropriate messages about
the risks and benefits of prostate cancer
screening for the general public, health care
providers, policy makers and other appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and
minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary,
who shall take into consideration recommendations by the United States Preventive
Services Task Force and shall seek input,
where appropriate, from professional societies
and other private and public entities, that
there is sufficient consensus on the effectiveness of prostate cancer screening—
(A) to screen men for prostate cancer as a
preventive health measure;
(B) to provide appropriate referrals for the
medical treatment of men who have been
screened under subparagraph (A) and to ensure, to the extent practicable, the provision
1 So

in original. Probably should be ‘‘prostate’’.

Page 168

of appropriate followup services and support
services such as case management;
(C) to establish mechanisms through
which State and local health departments
can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
(D) to improve, in consultation with the
Health Resources and Services Administration, the education, training, and skills of
health practitioners (including appropriate
allied health professionals) in the detection
and control of prostate cancer.
(8) To evaluate activities conducted under
paragraphs (1) through (7) through appropriate
surveillance or program monitoring activities.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees, with respect to the costs
to be incurred by the applicant in carrying out
the purpose described in such section, to make
available non-Federal contributions (in cash
or in kind under paragraph (2)) toward such
costs in an amount equal to not less than $1
for each $3 of Federal funds provided in the
grant. Such contributions may be made directly or through donations from public or private entities.
(2) Determination of amount of non-Federal
contribution
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including equipment or services
(and excluding indirect or overhead costs).
Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the
amount of such non-Federal contributions.
(B) In making a determination of the
amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess
of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) of
this section for the 2-year period preceding the
fiscal year for which the applicant involved is
applying to receive a grant under such subsection.
(C) In making a determination of the
amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall,
subject to subparagraphs (A) and (B) of this
paragraph, include any non-Federal amounts
expended pursuant to title XIX of the Social
Security Act [42 U.S.C. 1396 et seq.] by the applicant involved toward the purpose described
in paragraphs (1) and (2) of subsection (a) of
this section.
(c) Education on significance of early detection
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that, in carrying out subsection (a)(3) of this section, the applicant will
carry out education programs to communicate

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

to men, and to local health officials, the significance of the early detection of prostate cancer.
(d) Requirement of provision of all services by
date certain
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees—
(1) to ensure that, initially and throughout
the period during which amounts are received
pursuant to the grant, not less than 60 percent
of the grant is expended to provide each of the
services or activities described in paragraphs
(1) and (2) of such subsection;
(2) to ensure that, by the end of any second
fiscal year of payments pursuant to the grant,
each of the services or activities described in
such subsection is provided; and
(3) to ensure that not more than 40 percent
of the grant is expended to provide the services or activities described in paragraphs (3)
through (6) of such section.2
(e) Additional required agreements
(1) Priority for low-income men
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that low-income men,
and men at risk of prostate cancer, will be
given priority in the provision of services and
activities pursuant to paragraphs (1) and (2) of
such subsection.
(2) Limitation on imposition of fees for services
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities
under the grant, such charge—
(A) will be made according to a schedule of
charges that is made available to the public;
(B) will be adjusted to reflect the income
of the man involved; and
(C) will not be imposed on any man with
an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and
Budget and revised by the Secretary in accordance with section 9902(2) of this title.
(3) Relationship to items and services under
other programs
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that the grant will not be
expended to make payment for any item or
service to the extent that payment has been
made, or can reasonably be expected to be
made, with respect to such item or service—
(A) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) Coordination with other prostate cancer
programs
The Secretary may not make a grant under
subsection (a) of this section unless the appli-

cant involved agrees that the services and activities funded through the grant will be coordinated with other Federal, State, and local
prostate cancer programs.
(5) Limitation on administrative expenses
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that not more than 10
percent of the grant will be expended for administrative expenses with respect to the
grant.
(6) Restrictions on use of grant
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that the grant will not be
expended to provide inpatient hospital services for any individual.
(7) Records and audits
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees that—
(A) the applicant will establish such fiscal
control and fund accounting procedures as
may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 3
and
(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of
the grant.
(f) Reports to Secretary
The Secretary may not make a grant under
subsection (a) of this section unless the applicant involved agrees to submit to the Secretary
such reports as the Secretary may require with
respect to the grant.
(g) Description of intended uses of grant
The Secretary may not make a grant under
subsection (a) of this section unless—
(1) the applicant involved submits to the
Secretary a description of the purposes for
which the applicant intends to expend the
grant;
(2) the description identifies the populations,
areas, and localities in the applicant 4 with a
need for the services or activities described in
subsection (a) of this section;
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in
which the services and activities will be coordinated with any similar services or activities
of public or nonprivate entities; and
(4) the description provides assurances that
the grant funds will be used in the most costeffective manner.
(h) Requirement of submission of application
The Secretary may not make a grant under
subsection (a) of this section unless an application for the grant is submitted to the Secretary,
the application contains the description of in3 So

2 So

in original. Probably should be ‘‘subsection.’’

§ 247b–5

4 So

in original. Probably should be ‘‘subsection;’’.
in original. Probably should be ‘‘application’’.

§ 247b–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tended uses required in subsection (g) of this
section, and the application is in such form, is
made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out
this section.
(i) Method and amount of payment
The Secretary shall determine the amount of
a grant made under subsection (a) of this section. Payments under such grants may be made
in advance on the basis of estimates or by way
of reimbursement, with necessary adjustments
on account of the underpayments or overpayments, and in such installments and on such
terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(j) Technical assistance and provision of supplies
and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and
technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a) of this section. The Secretary may
provide such technical assistance directly or
through grants to, or contracts with, public
and private entities.
(2) Provision of supplies and services in lieu of
grant funds
(A) Upon the request of an applicant receiving a grant under subsection (a) of this section, the Secretary may, subject to subparagraph (B), provide supplies, equipment, and
services for the purpose of aiding the applicant
in carrying out such section and, for such purpose, may detail to the applicant any officer
or employee of the Department of Health and
Human Services.
(B) With respect to a request described in
subparagraph (A), the Secretary shall reduce
the amount of payments under the grant
under subsection (a) of this section to the applicant involved by an amount equal to the
costs of detailing personnel (including pay, allowances, and travel expenses) and the fair
market value of any supplies, equipment, or
services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend
the amounts withheld.
(k) ‘‘Units of local government’’ defined
For purposes of this section, the term ‘‘units
of local government’’ includes Indian tribes.
(l) Authorization of appropriations
(1) In general
For the purpose of carrying out this section,
there are authorized to be appropriated
$20,000,000 for fiscal year 1993, and such sums
as may be necessary for each of the fiscal
years 1994 through 2004.
(2) Allocation for technical assistance
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall
reserve not more than 20 percent for carrying
out subsection (j)(1) of this section.
(July 1, 1944, ch. 373, title III, § 317D, as added
Pub. L. 102–531, title III, § 308, Oct. 27, 1992, 106

Page 170

Stat. 3495; amended Pub. L. 103–43, title XX,
§ 2010(i)(1)(B)(iv), June 10, 1993, 107 Stat. 213; Pub.
L. 103–183, title VII, § 705(b), Dec. 14, 1993, 107
Stat. 2241; Pub. L. 105–392, title IV, § 401(a)(3),
Nov. 13, 1998, 112 Stat. 3587; Pub. L. 106–505, title
VI, § 602(a), Nov. 13, 2000, 114 Stat. 2345.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(b)(2)(C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–505, § 602(a)(1), added
subsec. (a) and struck out heading and text of former
subsec. (a). Text read as follows: ‘‘The Secretary, acting through the Director of the Centers for Disease
Control and Prevention, may make grants to States
and local health departments for the purpose of enabling such States and departments to carry out programs—
‘‘(1) to screen men for prostate cancer as a preventive health measure;
‘‘(2) to provide appropriate referrals for medical
treatment of men screened pursuant to paragraph (1)
and to ensure, to the extent practicable, the provision of appropriate follow-up services;
‘‘(3) to develop and disseminate public information
and education programs for the detection and control
of prostate cancer;
‘‘(4) to improve the education, training, and skills
of health professionals (including appropriate allied
health professionals) in the detection and control of
prostate cancer;
‘‘(5) to establish mechanisms through which the
States and such departments can monitor the quality
of screening procedures for prostate cancer, including
the interpretation of such procedures; and
‘‘(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program monitoring activities.’’
Subsec. (l)(1). Pub. L. 106–505, § 602(a)(2), substituted
‘‘2004’’ for ‘‘1998’’.
1998—Subsec. (l)(1). Pub. L. 105–392 made technical
amendment to directory language of Pub. L. 103–183.
See 1993 Amendment note below.
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 308, which enacted
this section.
Subsec. (l)(1). Pub. L. 103–183, as amended by Pub. L.
105–392, substituted ‘‘through 1998’’ for ‘‘through 1996’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.

§ 247b–6. National strategy for combating and
eliminating tuberculosis
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to States, political subdivisions, and other public entities for preventive
health service programs for the prevention, control, and elimination of tuberculosis.
(b) Research and development; demonstration
projects; education and training
With respect to the prevention, treatment,
control, and elimination of tuberculosis, the
Secretary may, directly or through grants to

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public or nonprofit private entities, carry out
the following:
(1) Research, with priority given to research
and development concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and research concerning
cases of tuberculosis that affect certain populations at risk for tuberculosis.
(2) Research and development and related
activities to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and
non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice.
(3) Demonstration projects for—
(A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug resistant and
extensively drug resistant strains of tuberculosis;
(B) the intensification of efforts to reduce
health disparities in the incidence of tuberculosis;
(C) the intensification of efforts to control
tuberculosis along the United States-Mexico
border and among United States-Mexico binational populations, including through expansion of the scope and number of programs
that—
(i) detect and treat binational cases of
tuberculosis; and
(ii) treat high-risk cases of tuberculosis
referred from Mexican health departments;
(D) the intensification of efforts to prevent, detect, and treat tuberculosis among
foreign-born persons who are in the United
States;
(E) the intensification of efforts to prevent, detect, and treat tuberculosis among
populations and settings documented as having a high risk for tuberculosis; and
(F) tuberculosis detection, control, and
prevention.
(4) Public information and education activities.
(5) Education, training, clinical skills improvement activities, and workplace exposure
prevention for health professionals, including
allied health personnel and emergency response employees.
(6) Support of Centers to carry out activities
under paragraphs (1) through (4).
(7) Collaboration with international organizations and foreign countries in carrying out
such activities.
(8) Develop, enhance, and expand information technologies that support tuberculosis
control including surveillance and database
management systems with cross-jurisdictional
capabilities, which shall conform to the standards and implementation specifications for
such
information
technologies
as
recommended by the Secretary.

§ 247b–6

(c) Cooperation with providers of primary health
services
The Secretary may make a grant under subsection (a) or (b) of this section only if the applicant for the grant agrees that, in carrying out
activities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or substance
abuse services, including entities receiving assistance under section 254b, 254b, or 256a of this
title 1 or under subchapter III–A or XVII of this
chapter.
(d) Application for grant
(1) In general
The Secretary may make a grant under subsection (a) or (b) of this section only if an application for the grant is submitted to the
Secretary and the application, subject to paragraph (2), is in such form, is made in such
manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection involved.
(2) Plan for prevention, control, and elimination
The Secretary may make a grant under subsection (a) of this section only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area
with respect to which the grant is sought.
(3) Determination of amount of nonfederal contributions
(A) Priority
In awarding grants under subsection (a) or
(b), the Secretary shall give highest priority
to an applicant that provides assurances
that the applicant will contribute non-Federal funds to carry out activities under this
section, which may be provided directly or
through donations from public or private entities and may be in cash or in kind, including equipment or services.
(B) Federal amounts not to be included as
contributions
Amounts provided by the Federal Government, or services assisted or subsidized to
any significant extent by the Federal Government, may not be included in determining the amount of non-Federal contributions
as described in subparagraph (A).
(e) Supplies and services in lieu of grant funds
(1) In general
Upon the request of a grantee under subsection (a) or (b) of this section, the Secretary
may, subject to paragraph (2), provide supplies, equipment, and services for the purpose
of aiding the grantee in carrying out the subsection involved and, for such purpose, may
detail to the State any officer or employee of
the Department of Health and Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the
1 See

References in Text notes below.

§ 247b–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amount of payments under the grant involved
by an amount equal to the costs of detailing
personnel and the fair market value of any
supplies, equipment, or services provided by
the Secretary. The Secretary shall, for the
payment of expenses incurred in complying
with such request, expend the amounts withheld.
(f) Advisory Council
(1) In general
The Secretary shall establish an advisory
council to be known as the Advisory Council
for the Elimination of Tuberculosis (in this
subsection referred to as the ‘‘Council’’).
(2) Duties
The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary. In addition, the
Council shall, with respect to eliminating such
disease, provide to the Secretary and other appropriate Federal officials advice on—
(A) coordinating the activities of the Department of Health and Human Services and
other Federal agencies that relate to the disease, including activities under subsection
(b);
(B) responding rapidly and effectively to
emerging issues in tuberculosis; and
(C) efficiently utilizing the Federal resources involved.
(3) Comprehensive plan
(A) In general
In carrying out paragraph (2), the Council
shall make or update recommendations on
the development, revision, and implementation of a comprehensive plan to eliminate
tuberculosis in the United States.
(B) Consultation
In carrying out subparagraph (A), the
Council may consult with appropriate public
and private entities, which may, subject to
the direction or discretion of the Secretary,
include—
(i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not officers or employees of the Federal Government and who
represent the disciplines relevant to tuberculosis elimination;
(ii) members of public-private partnerships or private entities established to address the elimination of tuberculosis;
(iii) members of national and international nongovernmental organizations
whose purpose is to eliminate tuberculosis;
(iv) members from the general public
who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis;
and
(v) scientists, physicians, laboratorians,
and other health professionals who reside
in a foreign country with a substantial incidence or prevalence of tuberculosis, and
who represent the specialties and disciplines relevant to the research under
consideration.

Page 172

(C) Certain components of plan
In carrying out subparagraph (A), the
Council shall, subject to the direction or discretion of the Secretary—
(i) consider recommendations for the involvement of the United States in continuing global and cross-border tuberculosis
control activities in countries where a
high incidence of tuberculosis directly affects the United States; and
(ii) review the extent to which progress
has been made toward eliminating tuberculosis.
(4) Biennial report
(A) In general
The Council shall submit a biennial report
to the Secretary, as determined necessary
by the Secretary, on the activities carried
under this section. Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have
been implemented, including with respect
to—
(i) activities under subsection (b); and
(ii) the national plan referred to in paragraph (3).
(B) Public
The Secretary shall make a report submitted under subparagraph (A) public.
(5) Composition
The Council shall be composed of—
(A) ex officio representatives from the
Centers for Disease Control and Prevention,
the National Institutes of Health, the United
States Agency for International Development, the Agency for Healthcare Research
and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other
Federal departments and agencies that carry
out significant activities related to tuberculosis;
(B) State and local tuberculosis control
and public health officials;
(C) individuals who are scientists, physicians, laboratorians, and other health professionals who represent disciplines relevant
to tuberculosis elimination; and
(D) members of national and international
nongovernmental organizations established
to address the elimination of tuberculosis.
(6) Staff, information, and other assistance
The Secretary shall provide to the Council
such staff, information, and other assistance
as may be necessary to carry out the duties of
the Council.
(g) Federal Tuberculosis Task Force
(1) Duties
The Federal Tuberculosis Task Force (in
this subsection referred to as the ‘‘Task
Force’’) shall provide to the Secretary and
other appropriate Federal officials advice on
research into new tools under subsection
(b)(2), including advice regarding the efficient
utilization of the Federal resources involved.

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(2) Comprehensive plan for new tools development
In carrying out paragraph (1), the Task
Force shall make recommendations on the development of a comprehensive plan for the creation of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.
(3) Consultation
In developing the comprehensive plan under
paragraph (1),2 the Task Force shall consult
with external parties including representatives from groups such as—
(A) scientists, physicians, laboratorians,
and other health professionals who represent
the specialties and disciplines relevant to
the research under consideration;
(B) members from public-private partnerships, private entities, or foundations (or
both) engaged in activities relevant to research under consideration;
(C) members of national and international
nongovernmental organizations established
to address tuberculosis elimination;
(D) members from the general public who
are knowledgeable with respect to tuberculosis including individuals who have or
have had tuberculosis; and
(E) scientists, physicians, laboratorians,
and other health professionals who reside in
a foreign country with a substantial incidence or prevalence of tuberculosis, and who
represent the specialties and disciplines relevant to the research under consideration.
(h) Authorization of appropriations
(1) General program
(A) In general
For the purpose of carrying out this section, there are authorized to be appropriated
$200,000,000 for fiscal year 2009, $210,000,000 for
fiscal year 2010, $220,500,000 for fiscal year
2011, $231,525,000 for fiscal year 2012, and
$243,101,250 for fiscal year 2013.
(B) Reservation for emergency grants
Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than 25 percent
for emergency grants under subsection (a)
for any geographic area, State, political subdivision of a State, or other public entity in
which there is, relative to other areas, a substantial number of cases of tuberculosis,
multidrug resistant tuberculosis, or extensively drug resistant tuberculosis or a substantial rate of increase in such cases.
(C) Priority
In allocating amounts appropriated under
subparagraph (A), the Secretary shall give
priority to allocating such amounts for
grants under subsection (a).
(D) Allocation of funds
(i) Requirement of formula
Of the amounts appropriated under subparagraph (A), not reserved under subpara2 So

in original. Probably should be ‘‘paragraph (2),’’.

§ 247b–6

graph (B), and allocated by the Secretary
for grants under subsection (a), the Secretary shall distribute a portion of such
amounts to grantees under subsection (a)
on the basis of a formula.
(ii) Relevant factors
The formula developed by the Secretary
under clause (i) shall take into account
the level of tuberculosis morbidity and
case complexity in the respective geographic area and may consider other factors relevant to tuberculosis in such area.
(iii) No change to formula required
This subparagraph does not require the
Secretary to modify the formula that was
used by the Secretary to distribute funds
to grantees under subsection (a) for fiscal
year 2009.
(2) Limitation
The authorization of appropriations established in paragraph (1) for a fiscal year is effective only if the amount appropriated under
such paragraph for such year equals or exceeds
the amount appropriated to carry out this section for fiscal year 2009.
(July 1, 1944, ch. 373, title III, § 317E, as added
Pub. L. 103–183, title III, § 301(a), Dec. 14, 1993, 107
Stat. 2233; amended Pub. L. 105–392, title IV,
§§ 401(b)(1), 405, Nov. 13, 1998, 112 Stat. 3587, 3588;
Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116
Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003,
117 Stat. 2023; Pub. L. 110–392, title I, §§ 101,
111(a), (c), 131, Oct. 13, 2008, 122 Stat. 4196, 4197,
4199, 4200.)
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing, referred to in subsec. (c), was in the
original a reference to section 329, meaning section 329
of act July 1, 1944, which was omitted in the general
amendment of subpart I (§ 254b et seq.) of part D of this
subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat.
3626.
Section 256a of this title, referred to in subsec. (c),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.
AMENDMENTS
2008—Pub. L. 110–392, § 101(1), substituted ‘‘National
strategy for combating and eliminating tuberculosis’’
for ‘‘Preventive health services regarding tuberculosis’’
in section catchline.
Subsec. (b). Pub. L. 110–392, § 101(2), amended subsec.
(b) generally. Prior to amendment, subsec. (b) related
to research, demonstration projects, education, and
training for the purpose of prevention, control, and
elimination of tuberculosis.
Subsec. (d)(3). Pub. L. 110–392, § 101(3), added par. (3).
Subsec. (f)(2) to (6). Pub. L. 110–392, § 111(a), added
pars. (2) to (5), redesignated former par. (5) as (6), and
struck out former pars. (2) to (4) which related to general duties, certain activities, and composition of the
Council, respectively.
Subsec. (g). Pub. L. 110–392, § 111(c)(2), added subsec.
(g). Former subsec. (g) redesignated (h).
Subsec. (h). Pub. L. 110–392, § 131, added subsec. (h)
and struck out former subsec. (h) which authorized appropriations for grants, research, demonstration
projects, education, and training for fiscal years 1994 to
2002.
Pub. L. 110–392, § 111(c)(1), redesignated subsec. (g) as
(h).

§ 247b–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2003—Subsec. (c). Pub. L. 108–163 substituted ‘‘254b’’
for ‘‘254c, 254b(h)’’ before ‘‘, or’’.
2002—Subsec. (c). Pub. L. 107–251 substituted ‘‘254b(h)’’
for ‘‘256’’.
1998—Subsec. (g)(1)(A). Pub. L. 105–392, § 405(1)(A), substituted ‘‘2002’’ for ‘‘1998’’.
Subsec. (g)(1)(B). Pub. L. 105–392, § 405(1)(B), substituted ‘‘25 percent’’ for ‘‘$50,000,000’’.
Subsec. (g)(2). Pub. L. 105–392, § 405(2), substituted
‘‘2002’’ for ‘‘1998’’.
Pub. L. 105–392, § 401(b)(1), substituted ‘‘carrying out
subsection (b)’’ for ‘‘making grants under subsection
(b)’’.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by section 401(b)(1) of Pub. L. 105–392
deemed to have taken effect immediately after enactment of Pub. L. 103–183, see section 401(e) of Pub. L.
105–392, set out as a note under section 242m of this
title.
CONSTRUCTION OF 2008 AMENDMENT
Pub. L. 110–392, title I, § 111(b), Oct. 13, 2008, 122 Stat.
4199, provided that: ‘‘With respect to the advisory council under section 317E(f) of the Public Health Service
Act [42 U.S.C. 247b–6(f)], the amendments made by subsection (a) [amending this section] may not be construed as terminating the membership on such council
of any individual serving as such a member as of the
day before the date of the enactment of this Act [Oct.
13, 2008].’’
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 247b–7. Loan repayment program
(a) In general
(1) Authority
Subject to paragraph (2), the Secretary may
carry out a program of entering into contracts
with appropriately qualified health professionals under which such health professionals
agree to conduct prevention activities, as employees of the Centers for Disease Control and
Prevention and the Agency for Toxic Substances and Disease Registry, in consideration
of the Federal Government agreeing to repay,
for each year of such service, not more than
$35,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to
paragraph (1) unless such professional—

Page 174

(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the
Centers for Disease Control and Prevention
or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1)
for a period of not less than 3 years.
(b) Applicability of certain provisions
With respect to the National Health Service
Corps Loan Repayment Program established in
subpart III of part D of this subchapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply
to the program established in this section in the
same manner and to the same extent as such
provisions apply to the National Health Service
Corps Loan Repayment Program.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $500,000
for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995
through 2002.
(d) Availability of appropriations
Amounts appropriated for a fiscal year for
contracts under subsection (a) of this section
shall remain available until the expiration of
the second fiscal year beginning after the fiscal
year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title III, § 317F, as added
Pub. L. 103–183, title VII, § 703, Dec. 14, 1993, 107
Stat. 2240; amended Pub. L. 105–392, title IV,
§ 406, Nov. 13, 1998, 112 Stat. 3588.)
AMENDMENTS
1998—Subsec. (a)(1). Pub. L. 105–392, § 406(1), substituted ‘‘$35,000’’ for ‘‘$20,000’’.
Subsec. (c). Pub. L. 105–392, § 406(2), substituted ‘‘2002’’
for ‘‘1998’’.
Subsec. (d). Pub. L. 105–392, § 406(3), added subsec. (d).

§ 247b–8. Fellowship and training programs
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish fellowship and training programs
to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease
detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such
programs to work, after receiving such training,
in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships
and training may be administered through the
use of either appointment or nonappointment
procedures.
(July 1, 1944, ch. 373, title III, § 317G, as added
Pub. L. 105–115, title IV, § 408(b)(1), Nov. 21, 1997,
111 Stat. 2371.)
EFFECTIVE DATE
Section 408(b)(2) of Pub. L. 105–115 provided that:
‘‘The amendment made by this subsection [enacting
this section] is deemed to have taken effect July 1,
1995.’’

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§ 247b–9. Diabetes in children and youth
(a) Surveillance on juvenile diabetes
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall develop a sentinel system to collect data
on juvenile diabetes, including with respect to
incidence and prevalence, and shall establish a
national database for such data.
(b) Type 2 diabetes in youth
The Secretary shall implement a national public health effort to address type 2 diabetes in
youth, including—
(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2 diabetes in youth
and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and
(2) developing and improving laboratory
methods to assist in diagnosis, treatment, and
prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia
and improving existing glucometers that
measure blood glucose.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317H, as added
Pub. L. 106–310, div. A, title IV, § 401, Oct. 17,
2000, 114 Stat. 1112.)
§ 247b–9a. Better diabetes care
(a) Short title
This section may be cited as the ‘‘Catalyst to
Better Diabetes Care Act of 2009’’.
(b) National diabetes report card
(1) In general
The Secretary, in collaboration with the Director of the Centers for Disease Control and
Prevention (referred to in this section as the
‘‘Director’’), shall prepare on a biennial basis
a national diabetes report card (referred to in
this section as a ‘‘Report Card’’) and, to the
extent possible, for each State.1
(2) Contents
(A) In general
Each Report Card shall include aggregate
health outcomes related to individuals diagnosed with diabetes and prediabetes including—
(i) preventative care practices and quality of care;
(ii) risk factors; and
(iii) outcomes.
(B) Updated reports
Each Report Card that is prepared after
the initial Report Card shall include trend
analysis for the Nation and, to the extent
possible, for each State, for the purpose of—
(i) tracking progress in meeting established national goals and objectives for im1 So

in original.

§ 247b–9a

proving diabetes care, costs, and prevalence (including Healthy People 2010); and
(ii) informing policy and program development.
(3) Availability
The Secretary, in collaboration with the Director, shall make each Report Card publicly
available, including by posting the Report
Card on the Internet.
(c) Improvement of vital statistics collection
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in collaboration with appropriate
agencies and States, shall—
(A) promote the education and training of
physicians on the importance of birth and
death certificate data and how to properly
complete these documents, including the
collection of such data for diabetes and
other chronic diseases;
(B) encourage State adoption of the latest
standard revisions of birth and death certificates; and
(C) work with States to re-engineer their
vital statistics systems in order to provide
cost-effective, timely, and accurate vital
systems data.
(2) Death certificate additional language
In carrying out this subsection, the Secretary may promote improvements to the collection of diabetes mortality data, including
the addition of a question for the individual
certifying the cause of death regarding whether the deceased had diabetes.
(d) Study on appropriate level of diabetes medical education
(1) In general
The Secretary shall, in collaboration with
the Institute of Medicine and appropriate associations and councils, conduct a study of the
impact of diabetes on the practice of medicine
in the United States and the appropriateness
of the level of diabetes medical education that
should be required prior to licensure, board
certification, and board recertification.
(2) Report
Not later than 2 years after March 23, 2010,
the Secretary shall submit a report on the
study under paragraph (1) to the Committees
on Ways and Means and Energy and Commerce
of the House of Representatives and the Committees on Finance and Health, Education,
Labor, and Pensions of the Senate.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary.
(Pub. L. 111–148, title X, § 10407, Mar. 23, 2010, 124
Stat. 976.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

§ 247b–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 247b–10. Compilation of data on asthma
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall—
(1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma
management;
(2) compile and annually publish data on the
prevalence of children suffering from asthma
in each State; and
(3) to the extent practicable, compile and
publish data on the childhood mortality rate
associated with asthma nationally.
(b) Surveillance activities
The Director of the Centers for Disease Control and Prevention, acting through the representative of the Director on the National
Asthma Education Prevention Program Coordinating Committee, shall, in carrying out subsection (a) of this section, provide an update on
surveillance activities at each Committee meeting.
(c) Collaborative efforts
The activities described in subsection (a)(1) of
this section may be conducted in collaboration
with eligible entities awarded a grant under section 280g of this title.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317I, as added
Pub. L. 106–310, div. A, title V, § 531, Oct. 17, 2000,
114 Stat. 1117.)
§ 247b–11. Effects of folic acid in prevention of
birth defects
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall expand and intensify programs (directly or
through grants or contracts) for the following
purposes:
(1) To provide education and training for
health professionals and the general public for
purposes of explaining the effects of folic acid
in preventing birth defects and for purposes of
encouraging each woman of reproductive capacity (whether or not planning a pregnancy)
to consume on a daily basis a dietary supplement that provides an appropriate level of
folic acid.
(2) To conduct research with respect to such
education and training, including identifying
effective strategies for increasing the rate of
consumption of folic acid by women of reproductive capacity.
(3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding
with respect to cleft lip, cleft palate, and
heart defects.
(4) To provide for appropriate epidemiological activities regarding folic acid and birth

Page 176

defects, including epidemiological activities
regarding neural tube defects.
(b) Consultations with States and private entities
In carrying out subsection (a) of this section,
the Secretary shall consult with the States and
with other appropriate public or private entities, including national nonprofit private organizations, health professionals, and providers of
health insurance and health plans.
(c) Technical assistance
The Secretary may (directly or through grants
or contracts) provide technical assistance to
public and nonprofit private entities in carrying
out the activities described in subsection (a) of
this section.
(d) Evaluations
The Secretary shall (directly or through
grants or contracts) provide for the evaluation
of activities under subsection (a) of this section
in order to determine the extent to which such
activities have been effective in carrying out the
purposes of the program under such subsection,
including the effects on various demographic
populations. Methods of evaluation under the
preceding sentence may include surveys of
knowledge and attitudes on the consumption of
folic acid and on blood folate levels. Such methods may include complete and timely monitoring of infants who are born with neural tube defects.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317J, as added
Pub. L. 106–310, div. A, title VI, § 601, Oct. 17,
2000, 114 Stat. 1118.)
§ 247b–12. Safe motherhood
(a) Surveillance
(1) Purpose
The purpose of this subsection is to develop
surveillance systems at the local, State, and
national level to better understand the burden
of maternal complications and mortality and
to decrease the disparities among population
at risk of death and complications from pregnancy.
(2) Activities
For the purpose described in paragraph (1),
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may carry out the following activities:
(A) The Secretary may establish and implement a national surveillance program to
identify and promote the investigation of
deaths and severe complications that occur
during pregnancy.
(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System
to provide surveillance and collect data in
each State.
(C) The Secretary may expand the Maternal and Child Health Epidemiology Program

Page 177

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to provide technical support, financial assistance, or the time-limited assignment of
senior epidemiologists to maternal and child
health programs in each State.
(b) Prevention research
(1) Purpose
The purpose of this subsection is to provide
the Secretary with the authority to further
expand research concerning risk factors, prevention strategies, and the roles of the family,
health care providers and the community in
safe motherhood.
(2) Research
The Secretary may carry out activities to
expand research relating to—
(A) encouraging preconception counseling,
especially for at risk populations such as
diabetics;
(B) the identification of critical components of prenatal delivery and postpartum
care;
(C) the identification of outreach and support services, such as folic acid education,
that are available for pregnant women;
(D) the identification of women who are at
high risk for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean sections;
(H) an examination of the higher rates of
maternal mortality among African American women;
(I) an examination of the relationship between domestic violence and maternal complications and mortality;
(J) preventing and reducing adverse health
consequences that may result from smoking,
alcohol and illegal drug use before, during
and after pregnancy;
(K) preventing infections that cause maternal and infant complications; and
(L) other areas determined appropriate by
the Secretary.
(c) Prevention programs
(1) In general
The Secretary may carry out activities to
promote safe motherhood, including—
(A) public education campaigns on healthy
pregnancies and the building of partnerships
with outside organizations concerned about
safe motherhood;
(B) education programs for physicians,
nurses and other health care providers; and
(C) activities to promote community support services for pregnant women.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317K, as added
Pub. L. 106–310, div. A, title IX, § 901, Oct. 17,
2000, 114 Stat. 1125.)
§ 247b–13. Prenatal and postnatal health
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall carry out programs—

§ 247b–14

(1) to collect, analyze, and make available
data on prenatal smoking, alcohol and illegal
drug use, including data on the implications of
such activities and on the incidence and prevalence of such activities and their implications;
(2) to conduct applied epidemiological research on the prevention of prenatal and postnatal smoking, alcohol and illegal drug use;
(3) to support, conduct, and evaluate the effectiveness of educational and cessation programs; and
(4) to provide information and education to
the public on the prevention and implications
of prenatal and postnatal smoking, alcohol
and illegal drug use.
(b) Grants
In carrying out subsection (a) of this section,
the Secretary may award grants to and enter
into contracts with States, local governments,
scientific and academic institutions, federally
qualified health centers, and other public and
nonprofit entities, and may provide technical
and consultative assistance to such entities.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317L, as added
Pub. L. 106–310, div. A, title IX, § 911, Oct. 17,
2000, 114 Stat. 1127.)
§ 247b–14. Oral health promotion and disease
prevention
(a) Grants to increase resources for community
water fluoridation
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may make grants to States and Indian
tribes for the purpose of increasing the resources available for community water fluoridation.
(2) Use of funds
A State shall use amounts provided under a
grant under paragraph (1)—
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on
the benefits of fluoridation; or
(D) to support the infrastructure necessary
to monitor and maintain the quality of
water fluoridation.
(b) Community water fluoridation
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in collaboration with the Director of
the Indian Health Service, shall establish a
demonstration project that is designed to assist rural water systems in successfully implementing the water fluoridation guidelines of
the Centers for Disease Control and Prevention that are entitled ‘‘Engineering and Administrative Recommendations for Water
Fluoridation, 1995’’ (referred to in this subsection as the ‘‘EARWF’’).

§ 247b–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Requirements
(A) Collaboration
In collaborating under paragraph (1), the
Directors referred to in such paragraph shall
ensure that technical assistance and training are provided to tribal programs located
in each of the 12 areas of the Indian Health
Service. The Director of the Indian Health
Service shall provide coordination and administrative support to tribes under this
section.
(B) General use of funds
Amounts made available under paragraph
(1) shall be used to assist small water systems in improving the effectiveness of water
fluoridation and to meet the recommendations of the EARWF.
(C) Fluoridation specialists
(i) In general
In carrying out this subsection, the Secretary shall provide for the establishment
of fluoridation specialist engineering positions in each of the Dental Clinical and
Preventive Support Centers through which
technical assistance and training will be
provided to tribal water operators, tribal
utility operators and other Indian Health
Service personnel working directly with
fluoridation projects.
(ii) Liaison
A fluoridation specialist shall serve as
the principal technical liaison between the
Indian Health Service and the Centers for
Disease Control and Prevention with respect to engineering and fluoridation issues.
(iii) CDC
The Director of the Centers for Disease
Control and Prevention shall appoint individuals to serve as the fluoridation specialists.
(D) Implementation
The project established under this subsection shall be planned, implemented and
evaluated over the 5-year period beginning
on the date on which funds are appropriated
under this section and shall be designed to
serve as a model for improving the effectiveness of water fluoridation systems of small
rural communities.
(3) Evaluation
In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary
shall ensure that such evaluation includes—
(A) the measurement of changes in water
fluoridation compliance levels resulting
from assistance provided under this section;
(B) the identification of the administrative, technical and operational challenges
that are unique to the fluoridation of small
water systems;
(C) the development of a practical model
that may be easily utilized by other tribal,
State, county or local governments in improving the quality of water fluoridation
with emphasis on small water systems; and

Page 178

(D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the benefits of optimally
fluoridated water.
(c) School-based dental sealant program
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in collaboration with the Administrator of the Health Resources and Services
Administration, shall award a grant to each of
the 50 States and territories and to Indians,
Indian tribes, tribal organizations and urban
Indian organizations (as such terms are defined in section 1603 of title 25) to provide for
the development of school-based dental sealant programs to improve the access of children to sealants.
(2) Use of funds
A State shall use amounts received under a
grant under paragraph (1) to provide funds to
eligible school-based entities or to public elementary or secondary schools to enable such
entities or schools to provide children with access to dental care and dental sealant services.
Such services shall be provided by licensed
dental health professionals in accordance with
State practice licensing laws.
(3) Eligibility
To be eligible to receive funds under paragraph (1), an entity shall—
(A) prepare and submit to the State an application at such time, in such manner and
containing such information as the State
may require; and
(B) be a public elementary or secondary
school—
(i) that is located in an urban area in
which and 1 more than 50 percent of the
student population is participating in Federal or State free or reduced meal programs; or
(ii) that is located in a rural area and,
with respect to the school district in which
the school is located, the district involved
has a median income that is at or below
235 percent of the poverty line, as defined
in section 9902(2) of this title.
(d) Oral health infrastructure
(1) Cooperative agreements
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall enter into cooperative agreements
with State, territorial, and Indian tribes or
tribal organizations (as those terms are defined in section 1603 of title 25) to establish
oral health leadership and program guidance,
oral health data collection and interpretation,2 (including determinants of poor oral
health among vulnerable populations), a
multi-dimensional delivery system for oral
health, and to implement science-based programs (including dental sealants and commu1 So
2 So

in original. The word ‘‘and’’ probably should not appear.
in original. The comma probably should not appear.

Page 179

TITLE 42—THE PUBLIC HEALTH AND WELFARE

nity water fluoridation) to improve oral
health.
(2) Authorization of appropriations
There is authorized to be appropriated such
sums as necessary to carry out this subsection
for fiscal years 2010 through 2014.
(e) Definitions
For purposes of this section, the term ‘‘Indian
tribe’’ means an Indian tribe or tribal organization as defined in section 450b(b) and section
450b(c) 3 of title 25.
(f) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 317M, as added
Pub. L. 106–310, div. A, title XVI, § 1602, Oct. 17,
2000, 114 Stat. 1148; amended Pub. L. 111–148, title
IV, § 4102(b), (c), Mar. 23, 2010, 124 Stat. 551, 552.)
REFERENCES IN TEXT
Section 450b of title 25, referred to in subsec. (e), has
been amended, and subsecs. (b) and (c) of section 450b
no longer define the terms ‘‘Indian tribe’’ and ‘‘tribal
organization’’. However, such terms are defined elsewhere in that section.
AMENDMENTS
2010—Subsec. (c)(1). Pub. L. 111–148, § 4102(b), substituted ‘‘shall award a grant to each of the 50 States
and territories and to Indians, Indian tribes, tribal organizations and urban Indian organizations (as such
terms are defined in section 1603 of title 25)’’ for ‘‘may
award grants to States and Indian tribes’’.
Subsecs. (d) to (f). Pub. L. 111–148, § 4102(c), added subsec. (d) and redesignated former subsecs. (d) and (e) as
(e) and (f), respectively.

§ 247b–14a. Identification of interventions that
reduce the burden and transmission of oral,
dental, and craniofacial diseases in high risk
populations; development of approaches for
pediatric oral and craniofacial assessment
(a) In general
The Secretary of Health and Human Services,
through the Maternal and Child Health Bureau,
the Indian Health Service, and in consultation
with the National Institutes of Health and the
Centers for Disease Control and Prevention,
shall—
(1) support community-based research that
is designed to improve understanding of the
etiology, pathogenesis, diagnosis, prevention,
and treatment of pediatric oral, dental,
craniofacial diseases and conditions and their
sequelae in high risk populations;
(2) support demonstrations of preventive
interventions in high risk populations including nutrition, parenting, and feeding techniques; and
(3) develop clinical approaches to assess individual patients for the risk of pediatric dental
disease.
(b) Compliance with State practice laws
Treatment and other services shall be provided pursuant to this section by licensed dental
3 See

References in Text note below.

§ 247b–15

health professionals in accordance with State
practice and licensing laws.
(c) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary to carry out this section for each 1 the fiscal years 2001 through 2005.
(Pub. L. 106–310, div. A, title XVI, § 1601, Oct. 17,
2000, 114 Stat. 1148.)
CODIFICATION
Section was enacted as part of the Children’s Health
Act of 2000, and not as part of the Public Health Service
Act which comprises this chapter.

§ 247b–15. Surveillance and education regarding
hepatitis C virus
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may (directly and through grants to public and
nonprofit private entities) provide for programs
to carry out the following:
(1) To cooperate with the States in implementing a national system to determine the
incidence of hepatitis C virus infection (in this
section referred to as ‘‘HCV infection’’) and to
assist the States in determining the prevalence of such infection, including the reporting of chronic HCV cases.
(2) To identify, counsel, and offer testing to
individuals who are at risk of HCV infection as
a result of receiving blood transfusions prior
to July 1992, or as a result of other risk factors.
(3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to
ensure, to the extent practicable, the provision of appropriate follow-up services.
(4) To develop and disseminate public information and education programs for the detection and control of HCV infection, with priority given to high risk populations as determined by the Secretary.
(5) To improve the education, training, and
skills of health professionals in the detection
and control of HCV infection, with priority
given to pediatricians and other primary care
physicians, and obstetricians and gynecologists.
(b) Laboratory procedures
The Secretary may (directly and through
grants to public and nonprofit private entities)
carry out programs to provide for improvements
in the quality of clinical-laboratory procedures
regarding hepatitis C, including reducing variability in laboratory results on hepatitis C antibody and PCR testing.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
1 So

in original. Probably should be followed by ‘‘of’’.

§ 247b–16

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 180

(July 1, 1944, ch. 373, title III, § 317N, as added
Pub. L. 106–310, div. A, title XVIII, § 1801, Oct. 17,
2000, 114 Stat. 1152.)

be appropriated to the Department of Health and
Human Services and the Department of Labor
$10,000,000 for fiscal year 2001.’’

STUDY AND DEMONSTRATION PROJECTS REGARDING
CASES OF HEPATITIS C AMONG CERTAIN EMERGENCY
RESPONSE EMPLOYEES

§ 247b–16. Grants for lead poisoning related activities

Pub. L. 106–398, § 1 [[div. A], title XVII, § 1704], Oct. 30,
2000, 114 Stat. 1654, 1654A–365, provided that:
‘‘(a) STUDY REGARDING PREVALENCE AMONG CERTAIN
EMERGENCY RESPONSE EMPLOYEES.—
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the
‘Secretary’), in consultation with the Secretary of
Labor, shall conduct a study to determine—
‘‘(A) an estimate of the prevalence of hepatitis C
among designated emergency response employees
in the United States; and
‘‘(B) the likely means through which such employees become infected with such disease in the
course of performing their duties as such employees.
‘‘(2) DESIGNATED EMERGENCY RESPONSE EMPLOYEES.—For purposes of this section, the term ‘designated emergency response employees’ means firefighters, paramedics, and emergency medical technicians who are employees or volunteers of units of
local government.
‘‘(3) DATE CERTAIN FOR COMPLETION; REPORT TO CONGRESS.—The Secretary shall commence the study
under paragraph (1) not later than 90 days after the
date of the enactment of this Act [Oct. 30, 2000]. Not
later than one year after such date, the Secretary
shall complete the study and submit to the Congress
a report describing the findings of the study.
‘‘(b) DEMONSTRATION PROJECTS REGARDING TRAINING
AND TREATMENT.—
‘‘(1) IN GENERAL.—The Secretary, in consultation
with the Secretary of Labor, shall make grants to
qualifying local governments for the purpose of carrying out demonstration projects that (directly or
through arrangements with nonprofit private entities) carry out each of the following activities:
‘‘(A) Training designated emergency response employees in minimizing the risk of infection with
hepatitis C in performing their duties as such employees.
‘‘(B) Testing such employees for infection with
the disease.
‘‘(C) Treating the employees for the disease.
‘‘(2) QUALIFYING LOCAL GOVERNMENTS.—For purposes
of this section, the term ‘qualifying local government’ means a unit of local government whose population of designated emergency response employees
has a prevalence of hepatitis C that is not less than
200 percent of the national average for the prevalence
of such disease in such populations.
‘‘(3) CONFIDENTIALITY.—A grant may be made under
paragraph (1) only if the qualifying local government
involved agrees to ensure that information regarding
the testing or treatment of designated emergency response employees pursuant to the grant is maintained confidentially in a manner not inconsistent
with applicable law.
‘‘(4) EVALUATIONS.—The Secretary shall provide for
an evaluation of each demonstration project under
paragraph (1) in order to determine the extent to
which the project has been effective in carry [sic] out
the activities described in such paragraph.
‘‘(5) REPORT TO CONGRESS.—Not later than 180 days
after the date on which all grants under paragraph (1)
have been expended, the Secretary shall submit to
Congress a report providing—
‘‘(A) a summary of evaluations under paragraph
(4); and
‘‘(B) the recommendations of the Secretary for
administrative or legislative initiatives regarding
the activities described in paragraph (1).
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized to

(a) Authority to make grants
(1) In general
The Secretary shall make grants to States
to support public health activities in States
and localities where data suggests that at
least 5 percent of preschool-age children have
an elevated blood lead level through—
(A) effective, ongoing outreach and community education targeted to families most
likely to be at risk for lead poisoning;
(B) individual family education activities
that are designed to reduce ongoing exposures to lead for children with elevated
blood lead levels, including through home
visits and coordination with other programs
designed to identify and treat children at
risk for lead poisoning; and
(C) the development, coordination and implementation
of
community-based
approaches for comprehensive lead poisoning
prevention from surveillance to lead hazard
control.
(2) State match
A State is not eligible for a grant under this
section unless the State agrees to expend
(through State or local funds) $1 for every $2
provided under the grant to carry out the activities described in paragraph (1).
(3) Application
To be eligible to receive a grant under this
section, a State shall submit an application to
the Secretary in such form and manner and
containing such information as the Secretary
may require.
(b) Coordination with other children’s programs
A State shall identify in the application for a
grant under this section how the State will coordinate operations and activities under the grant
with—
(1) other programs operated in the State
that serve children with elevated blood lead
levels, including any such programs operated
under title V, XIX, or XXI of the Social Security Act [42 U.S.C. 701 et seq., 1396 et seq.,
1397aa et seq.]; and
(2) one or more of the following—
(A) the child welfare and foster care and
adoption assistance programs under parts B
and E of title IV of such Act [42 U.S.C. 620 et
seq., 670 et seq.];
(B) the head start program established
under the Head Start Act (42 U.S.C. 9831 et
seq.);
(C) the program of assistance under the
special supplemental nutrition program for
women, infants and children (WIC) under
section 1786 of this title;
(D) local public and private elementary or
secondary schools; or
(E) public housing agencies, as defined in
section 1437a of this title.
(c) Performance measures
The Secretary shall establish needs indicators
and performance measures to evaluate the ac-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tivities carried out under grants awarded under
this section. Such indicators shall be commensurate with national measures of maternal and
child health programs and shall be developed in
consultation with the Director of the Centers for
Disease Control and Prevention.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of the fiscal years 2001 through
2005.
(July 1, 1944, ch. 373, title III, § 317O, as added
Pub. L. 106–310, div. A, title XXV, § 2502(a), Oct.
17, 2000, 114 Stat. 1162.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(1),
(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Parts B and E of title IV of the Act are classified generally to parts B (§ 620 et seq.) and E (§ 670 et
seq.), respectively, of subchapter IV of chapter 7 of this
title. Titles V, XIX, and XXI of the Act are classified
generally to subchapters V (§ 701 et seq.), XIX (§ 1396 et
seq.), and XXI (§ 1397aa et seq.), respectively, of chapter
7 of this title. For complete classification of this Act to
the Code, see section 1305 of this title and Tables.
The Head Start Act, referred to in subsec. (b)(2)(B), is
subchapter B (§§ 635–657) of chapter 8 of subtitle A of
title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, as
amended, which is classified generally to subchapter II
(§ 9831 et seq.) of chapter 105 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 9801 of this title and Tables.

§ 247b–17.
Law)

Human

papillomavirus

(Johanna’s

(a) Surveillance
(1) In general
The Secretary, acting through the Centers
for Disease Control and Prevention, shall—
(A) enter into cooperative agreements
with States and other entities to conduct
sentinel surveillance or other special studies
that would determine the prevalence in various age groups and populations of specific
types of human papillomavirus (referred to
in this section as ‘‘HPV’’) in different sites
in various regions of the United States,
through collection of special specimens for
HPV using a variety of laboratory-based
testing and diagnostic tools; and
(B) develop and analyze data from the HPV
sentinel surveillance system described in
subparagraph (A).
(2) Report
The Secretary shall make a progress report
to the Congress with respect to paragraph (1)
no later than 1 year after the effective date of
this section.
(b) Prevention activities; education program
(1) In general
The Secretary, acting through the Centers
for Disease Control and Prevention, shall conduct prevention research on HPV, including—
(A) behavioral and other research on the
impact of HPV-related diagnosis on individuals;
(B) formative research to assist with the
development of educational messages and in-

§ 247b–17

formation for the public, for patients, and
for their partners about HPV;
(C) surveys of physician and public knowledge, attitudes, and practices about genital
HPV infection; and
(D) upon the completion of and based on
the findings under subparagraphs (A)
through (C), develop and disseminate educational materials for the public and health
care providers regarding HPV and its impact
and prevention.
(2) Report; final proposal
The Secretary shall make a progress report
to the Congress with respect to paragraph (1)
not later than 1 year after the effective date of
this section, and shall develop a final report
not later than 3 years after such effective
date, including a detailed summary of the significant findings and problems and the best
strategies to prevent future infections, based
on available science.
(c) HPV education and prevention
(1) In general
The Secretary shall prepare and distribute
educational materials for health care providers and the public that include information on
HPV. Such materials shall address—
(A) modes of transmission;
(B) consequences of infection, including
the link between HPV and cervical cancer;
(C) the available scientific evidence on the
effectiveness or lack of effectiveness of
condoms in preventing infection with HPV;
and
(D) the importance of regular Pap smears,
and other diagnostics for early intervention
and prevention of cervical cancer purposes
in preventing cervical cancer.
(2) Medically accurate information
Educational material under paragraph (1),
and all other relevant educational and prevention materials prepared and printed from this
date forward for the public and health care
providers by the Secretary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control
and Prevention, and the Health Resources and
Services Administration), or by contractors,
grantees, or subgrantees thereof, that are specifically designed to address STDs including
HPV shall contain medically accurate information regarding the effectiveness or lack of
effectiveness of condoms in preventing the
STD the materials are designed to address.
Such requirement only applies to materials
mass produced for the public and health care
providers, and not to routine communications.
(d) Johanna’s Law
(1) National public awareness campaign
(A) In general
The Secretary shall carry out a national
campaign to increase the awareness and
knowledge of health care providers and
women with respect to gynecologic cancers.
(B) Written materials
Activities under the national campaign
under subparagraph (A) shall include—

§ 247b–17

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) maintaining a supply of written materials that provide information to the public on gynecologic cancers; and
(ii) distributing the materials to members of the public upon request.
(C) Public service announcements
Activities under the national campaign
under subparagraph (A) shall, in accordance
with applicable law and regulations, include
developing and placing, in telecommunications media, public service announcements
intended to encourage women to discuss
with their physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in which the
written materials referred to in subparagraph (B) can be obtained upon request, and
shall call attention to early warning signs
and risk factors based on the best available
medical information.
(2) Report and strategy
(A) Report
Not later than 6 months after January 12,
2007, the Secretary shall submit to the Congress a report including the following:
(i) A description of the past and present
activities of the Department of Health and
Human Services to increase awareness and
knowledge of the public with respect to
different types of cancer, including gynecologic cancers.
(ii) A description of the past and present
activities of the Department of Health and
Human Services to increase awareness and
knowledge of health care providers with
respect to different types of cancer, including gynecologic cancers.
(iii) For each activity described pursuant
to clause (i) or (ii), a description of the following:
(I) The funding for such activity for
fiscal year 2006 and the cumulative funding for such activity for previous fiscal
years.
(II) The background and history of
such activity, including—
(aa) the goals of such activity;
(bb) the communications objectives
of such activity;
(cc) the identity of each agency within the Department of Health and
Human Services responsible for any aspect of the activity; and
(dd) how such activity is or was expected to result in change.
(III) How long the activity lasted or is
expected to last.
(IV) The outcomes observed and the
evaluation methods, if any, that have
been, are being, or will be used with respect to such activity.
(V) For each such outcome or evaluation method, a description of the associated results, analyses, and conclusions.
(B) Strategy
(i) Development; submission to Congress
Not later than 3 months after submitting
the report required by subparagraph (A),

Page 182

the Secretary shall develop and submit to
the Congress a strategy for improving efforts to increase awareness and knowledge
of the public and health care providers
with respect to different types of cancer,
including gynecological cancers.
(ii) Consultation
In developing the strategy under clause
(i), the Secretary should consult with
qualified private sector groups, including
nonprofit organizations.
(3) Full compliance
(A) IN GENERAL.—Not later than March 1,
2008, the Secretary shall ensure that all provisions of this section, including activities directed to be carried out by the Centers for Disease Control and Prevention and the Food and
Drug Administration, are fully implemented
and being complied with. Not later than April
30, 2008, the Secretary shall submit to Congress a report that certifies compliance with
the preceding sentence and that contains a description of all activities undertaken to
achieve such compliance.
(B) If the Secretary fails to submit the certification as provided for under subparagraph
(A), the Secretary shall, not later than 3
months after the date on which the report is
to be submitted under subparagraph (A), and
every 3 months thereafter, submit to Congress
an explanation as to why the Secretary has
not yet complied with the first sentence of
subparagraph (A), a detailed description of all
actions undertaken within the month for
which the report is being submitted to bring
the Secretary into compliance with such sentence, and the anticipated date the Secretary
expects to be in full compliance with such sentence.
(4) Consultation with nonprofit gynecologic
cancer organizations
In carrying out the national campaign under
this subsection, the Secretary shall consult
with nonprofit gynecologic cancer organizations, with a mission both to conquer ovarian
or other gynecologic cancer and to provide
outreach to State and local governments and
communities, for the purpose of determining
the best practices for providing gynecologic
cancer information and outreach services to
varied populations.
(6) 1 Authorization of appropriations
For the purpose of carrying out this subsection, there is authorized to be appropriated
$16,500,000 for the period of fiscal years 2007
through 2009 and $18,000,000 for the period of
fiscal years 2012 through 2014.
(July 1, 1944, ch. 373, title III, § 317P, as added
Pub. L. 106–554, § 1(a)(1) [title V, § 516(a)], Dec. 21,
2000, 114 Stat. 2763, 2763A–72; amended Pub. L.
109–475, § 2, Jan. 12, 2007, 120 Stat. 3565; Pub. L.
111–324, § 1, Dec. 22, 2010, 124 Stat. 3536.)
REFERENCES IN TEXT
Johanna’s Law, referred to in section catchline and
subsec. (d), is Pub. L. 109–475, Jan. 12, 2007, 120 Stat.
1 So

in original. No par. (5) has been enacted.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

3565, also known as the Gynecologic Cancer Education
and Awareness Act of 2005, which amended this section.
For complete classification of this Act to the Code, see
Short Title of 2007 Amendment note set out under section 201 of this title and Tables.
The effective date of this section, referred to in subsecs. (a)(2) and (b)(2), is the date of enactment of Pub.
L. 106–554, which was approved Dec. 21, 2000.
AMENDMENTS
2010—Subsec. (d)(4). Pub. L. 111–324, § 1(b), added par.
(4). Former par. (4) redesignated (6).
Pub. L. 111–324, § 1(a)(1), inserted ‘‘and $18,000,000 for
the period of fiscal years 2012 through 2014’’ after
‘‘2009’’.
Subsec. (d)(6). Pub. L. 111–324, § 1(a)(2), redesignated
par. (4) as (6).
2007—Pub. L. 109–475, § 2(1), inserted ‘‘(Johanna’s
Law)’’ after ‘‘papillomavirus’’ in section catchline.
Subsec. (d). Pub. L. 109–475, § 2(2), added subsec. (d).

§ 247b–18. Surveillance and research regarding
muscular dystrophy
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may award grants and cooperative agreements
to public or nonprofit private entities (including
health departments of States and political subdivisions of States, and including universities
and other educational entities) for the collection, analysis, and reporting of data on
Duchenne and other forms of muscular dystrophy. In making such awards, the Secretary
may provide direct technical assistance in lieu
of cash.
(b) National muscular dystrophy epidemiology
program
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may award grants to public or nonprofit private
entities (including health departments of States
and political subdivisions of States, and including universities and other educational entities)
for the purpose of carrying out epidemiological
activities regarding Duchenne and other forms
of muscular dystrophies, including collecting
and analyzing information on the number, incidence, correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary
shall provide for a national surveillance program. In making awards under this subsection,
the Secretary may provide direct technical assistance in lieu of cash.
(c) Coordination with centers of excellence
The Secretary shall ensure that epidemiological information under subsections (a) and (b) of
this section is made available to centers of excellence supported under section 283g(b) of this
title by the Director of the National Institutes
of Health.
(d) Data
In carrying out this section, the Secretary
may ensure that any data on patients that is
collected as part of the Muscular Dystrophy
STARnet (under a grant under this section) is
regularly updated to reflect changes in patient
condition over time.
(e) Reports and study
(1) Annual report
Not later than 18 months after October 8,
2008, and annually thereafter, the Director of

§ 247b–18

the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress a report—
(A) concerning the activities carried out
by MD STARnet site 1 funded under this section during the year for which the report is
prepared;
(B) containing the data collected and findings derived from the MD STARnet sites
each fiscal year (as funded under a grant
under this section during fiscal years 2008
through 2012); and
(C) that every 2 years outlines prospective
data collection objectives and strategies.
(2) Tracking health outcomes
The Secretary may provide health outcome
data on the health and survival of people with
muscular dystrophy.
(f) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary to carry out this section.
(July 1, 1944, ch. 373, title III, § 317Q, as added
Pub. L. 107–84, § 4, Dec. 18, 2001, 115 Stat. 828;
amended Pub. L. 110–361, § 3, Oct. 8, 2008, 122
Stat. 4010.)
AMENDMENTS
2008—Subsecs. (d) to (f). Pub. L. 110–361 added subsecs.
(d) and (e) and redesignated former subsec. (d) as (f).
FINDINGS
Pub. L. 107–84, § 2, Dec. 18, 2001, 115 Stat. 823, provided
that: ‘‘Congress makes the following findings:
‘‘(1) Of the childhood muscular dystrophies,
Duchenne Muscular Dystrophy (DMD) is the world’s
most common and catastrophic form of genetic childhood disease, and is characterized by a rapidly progressive muscle weakness that almost always results
in death, usually by 20 years of age.
‘‘(2) Duchenne muscular dystrophy is genetically
inherited, and mothers are the carriers in approximately 70 percent of all cases.
‘‘(3) If a female is a carrier of the dystrophin gene,
there is a 50 percent chance per birth that her male
offspring will have Duchenne muscular dystrophy,
and a 50 percent chance per birth that her female offspring will be carriers.
‘‘(4) Duchenne is the most common lethal genetic
disorder of childhood worldwide, affecting approximately 1 in every 3,500 boys worldwide.
‘‘(5) Children with muscular dystrophy exhibit extreme symptoms of weakness, delay in walking, waddling gait, difficulty in climbing stairs, and progressive mobility problems often in combination with
muscle hypertrophy.
‘‘(6) Other forms of muscular dystrophy affecting
children and adults include Becker, limb girdle, congenital,
facioscapulohumeral,
myotonic,
oculopharyngeal, distal, and Emery-Dreifuss muscular dystrophies.
‘‘(7) Myotonic muscular dystrophy (also known as
Steinert’s disease and dystrophia myotonica) is the
second most prominent form of muscular dystrophy
and the type most commonly found in adults. Unlike
any of the other muscular dystrophies, the muscle
weakness is accompanied by myotonia (delayed relaxation of muscles after contraction) and by a variety
of abnormalities in addition to those of muscle.
‘‘(8) Facioscapulohumeral muscular dystrophy (referred to in this section as ‘FSHD’) is a neuromuscular disorder that is inherited genetically and
1 So

in original. Probably should be plural.

§ 247b–19

TITLE 42—THE PUBLIC HEALTH AND WELFARE

has an estimated frequency of 1 in 20,000. FSHD, affecting between 15,000 to 40,000 persons, causes a progressive and sever [sic] loss of skeletal muscle gradually bringing weakness and reduced mobility. Many
persons with FSHD become severely physically disabled and spend many decades in a wheelchair.
‘‘(9) FSHD is regarded as a novel genetic phenomenon resulting from a crossover of subtelomeric DNA
and may be the only human disease caused by a deletion-mutation.
‘‘(10) Each of the muscular dystrophies, though distinct in progressivity and severity of symptoms, have
a devastating impact on tens of thousands of children
and adults throughout the United States and worldwide and impose severe physical and economic burdens on those affected.
‘‘(11) Muscular dystrophies have a significant impact on quality of life—not only for the individual
who experiences its painful symptoms and resulting
disability, but also for family members and caregivers.
‘‘(12) Development of therapies for these disorders,
while realistic with recent advances in research, is
likely to require costly investments and infrastructure to support gene and other therapies.
‘‘(13) There is a shortage of qualified researchers in
the field of neuromuscular research.
‘‘(14) Many family physicians and health care professionals lack the knowledge and resources to detect
and properly diagnose the disease as early as possible,
thus exacerbating the progressiveness of symptoms in
cases that go undetected or misdiagnosed.
‘‘(15) There is a need for efficient mechanisms to
translate clinically relevant findings in muscular
dystrophy research from basic science to applied
work.
‘‘(16) Educating the public and health care community throughout the country about this devastating
disease is of paramount importance and is in every
respect in the public interest and to the benefit of all
communities.’’
REPORT TO CONGRESS
Pub. L. 107–84, § 6, Dec. 18, 2001, 115 Stat. 829, which directed the Secretary of Health and Human Services to
prepare and submit to appropriate committees of Congress a report concerning the implementation of Pub.
L. 107–84 not later than Jan. 1, 2003, and each Jan. 1
thereafter, was repealed by Pub. L. 109–482, title I,
§ 104(b)(3)(H), Jan. 15, 2007, 120 Stat. 3694.

§ 247b–19. Information and education
(a) In general
The Secretary of Health and Human Services
(referred to in this Act as the ‘‘Secretary’’) shall
establish and implement a program to provide
information and education on muscular dystrophy to health professionals and the general
public, including information and education on
advances in the diagnosis and treatment of muscular dystrophy and training and continuing
education through programs for scientists, physicians, medical students, and other health professionals who provide care for patients with
muscular dystrophy.
(b) Stipends
The Secretary may use amounts made available under this section provides 1 stipends for
health professionals who are enrolled in training
programs under this section.
(c) Requirements
In carrying out this section, the Secretary
may—
1 So

in original. Probably should be ‘‘to provide’’.

Page 184

(1) partner with leaders in the muscular dystrophy patient community;
(2) cooperate with professional organizations
and the patient community in the development and issuance of care considerations for
Duchenne-Becker muscular dystrophy, and
other forms of muscular dystrophy, and in
periodic review and updates, as appropriate;
and
(3) widely disseminate the Duchenne-Becker
muscular dystrophy and other forms of muscular dystrophy care considerations as broadly
as possible, including through partnership opportunities with the muscular dystrophy patient community.
(d) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary to carry out this section.
(Pub. L. 107–84, § 5, Dec. 18, 2001, 115 Stat. 828;
Pub. L. 110–361, § 4, Oct. 8, 2008, 122 Stat. 4011.)
REFERENCES IN TEXT
This Act, referred to in subsec. (a), is Pub. L. 107–84,
Dec. 18, 2001, 115 Stat. 823, known as the Muscular Dystrophy Community Assistance, Research and Education
Amendments of 2001 and also as the MD–CARE Act. For
complete classification of this Act to the Code, see
Short Title of 2001 Amendment note set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Muscular Dystrophy Community Assistance, Research and Education
Amendments of 2001, also known as the MD–CARE Act,
and not as part of the Public Health Service Act which
comprises this chapter.
AMENDMENTS
2008—Subsecs. (c), (d). Pub. L. 110–361 added subsec.
(c) and redesignated former subsec. (c) as (d).

§ 247b–20. Food safety grants
(a) In general
The Secretary may award grants to States and
Indian tribes (as defined in section 450b(e) of
title 25) to expand participation in networks to
enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed
for such participation.
(b) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$19,500,000 for fiscal year 2010, and such sums as
may be necessary for each of the fiscal years
2011 through 2015.
(July 1, 1944, ch. 373, title III, § 317R, as added
Pub. L. 107–188, title III, § 312, June 12, 2002, 116
Stat. 674; amended Pub. L. 108–75, § 2(1), Aug. 15,
2003, 117 Stat. 898; Pub. L. 111–353, title II,
§ 205(d), Jan. 4, 2011, 124 Stat. 3939.)
AMENDMENTS
2011—Subsec. (b). Pub. L. 111–353 substituted ‘‘2010’’
for ‘‘2002’’ and ‘‘2011 through 2015’’ for ‘‘2003 through
2006’’.
2003—Pub. L. 108–75 made technical amendment relating to placement of section within original act.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 247b–21. Mosquito-borne diseases; coordination
grants to States; assessment and control
grants to political subdivisions
(a) Coordination grants to States; assessment
grants to political subdivisions
(1) In general
With respect to mosquito control programs
to prevent and control mosquito-borne diseases (referred to in this section as ‘‘control
programs’’), the Secretary, acting through the
Director of the Centers for Disease Control
and Prevention, may make grants to States
for the purpose of—
(A) coordinating control programs in the
State involved; and
(B) assisting such State in making grants
to political subdivisions of the State to conduct assessments to determine the immediate needs in such subdivisions for control
programs, and to develop, on the basis of
such assessments, plans for carrying out
control programs in the subdivisions.
(2) Preference in making grants
In making grants under paragraph (1), the
Secretary shall give preference to States that
have one or more political subdivisions with
an incidence, prevalence, or high risk of mosquito-borne disease, or a population of infected mosquitoes, that is substantial relative
to political subdivisions in other States.
(3) Certain requirements
A grant may be made under paragraph (1)
only if—
(A) the State involved has developed, or
agrees to develop, a plan for coordinating
control programs in the State, and the plan
takes into account any assessments or plans
described in subsection (b)(3) of this section
that have been conducted or developed, respectively, by political subdivisions in the
State;
(B) in developing such plan, the State consulted or will consult (as the case may be
under subparagraph (A)) with political subdivisions in the State that are carrying out
or planning to carry out control programs;
(C) the State agrees to monitor control
programs in the State in order to ensure
that the programs are carried out in accordance with such plan, with priority given to
coordination of control programs in political
subdivisions described in paragraph (2) that
are contiguous;
(D) the State agrees that the State will
make grants to political subdivisions as described in paragraph (1)(B), and that such a
grant will not exceed $10,000; and
(E) the State agrees that the grant will be
used to supplement, and not supplant, State
and local funds available for the purpose described in paragraph (1).
(4) Reports to Secretary
A grant may be made under paragraph (1)
only if the State involved agrees that, promptly after the end of the fiscal year for which the
grant is made, the State will submit to the
Secretary a report that—
(A) describes the activities of the State
under the grant; and

§ 247b–21

(B) contains an evaluation of whether the
control programs of political subdivisions in
the State were effectively coordinated with
each other, which evaluation takes into account any reports that the State received
under subsection (b)(5) of this section from
such subdivisions.
(5) Number of grants
A State may not receive more than one
grant under paragraph (1).
(b) Prevention and control grants to political
subdivisions
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may make grants to political subdivisions of States or consortia of political subdivisions of States, for the operation of control programs.
(2) Preference in making grants
In making grants under paragraph (1), the
Secretary shall give preference to a political
subdivision or consortium of political subdivisions that—
(A) has—
(i) a history of elevated incidence or
prevalence of mosquito-borne disease;
(ii) a population of infected mosquitoes;
or
(iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence or prevalence of mosquitoborne disease in the pending fiscal year;
(B) demonstrates to the Secretary that
such political subdivision or consortium of
political subdivisions will, if appropriate to
the mosquito circumstances involved, effectively coordinate the activities of the control programs with contiguous political subdivisions;
(C) demonstrates to the Secretary (directly or through State officials) that the
State in which such a political subdivision
or consortium of political subdivisions is located has identified or will identify geographic areas in such State that have a significant need for control programs and will
effectively coordinate such programs in such
areas; and
(D) is located in a State that has received
a grant under subsection (a) of this section.
(3) Requirement of assessment and plan
A grant may be made under paragraph (1)
only if the political subdivision or consortium
of political subdivisions involved—
(A) has conducted an assessment to determine the immediate needs in such subdivision or consortium for a control program, including an entomological survey of potential
mosquito breeding areas; and
(B) has, on the basis of such assessment,
developed a plan for carrying out such a program.
(4) Requirement of matching funds
(A) In general
With respect to the costs of a control program to be carried out under paragraph (1)

§ 247b–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

by a political subdivision or consortium of
political subdivisions, a grant under such
paragraph may be made only if the subdivision or consortium agrees to make available
(directly or through donations from public
or private entities) non-Federal contributions toward such costs in an amount that is
not less than 1⁄3 of such costs ($1 for each $2
of Federal funds provided in the grant).
(B) Determination of amount contributed
Non-Federal contributions required in subparagraph (A) may be in cash or in kind,
fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal
contributions.
(C) Waiver
The Secretary may waive the requirement
established in subparagraph (A) if the Secretary determines that extraordinary economic conditions in the political subdivision
or consortium of political subdivisions involved justify the waiver.
(5) Reports to Secretary
A grant may be made under paragraph (1)
only if the political subdivision or consortium
of political subdivisions involved agrees that,
promptly after the end of the fiscal year for
which the grant is made, the subdivision or
consortium will submit to the Secretary, and
to the State within which the subdivision or
consortium is located, a report that describes
the control program and contains an evaluation of whether the program was effective.
(6) Amount of grant; number of grants
(A) Amount of grant
(i) Single political subdivision
A grant under paragraph (1) awarded to a
political subdivision for a fiscal year may
not exceed $100,000.
(ii) Consortium
A grant under paragraph (1) awarded to a
consortium of 2 or more political subdivisions may not exceed $110,000 for each political subdivision. A consortium is not required to provide matching funds under
paragraph (4) for any amounts received by
such consortium in excess of amounts each
political subdivision would have received
separately.
(iii) Waiver of requirement
A grant may exceed the maximum
amount in clause (i) or (ii) if the Secretary
determines that the geographical area covered by a political subdivision or consortium awarded a grant under paragraph (1)
has an extreme need due to the size or density of—
(I) the human population in such geographical area; or
(II) the mosquito population in such
geographical area.

Page 186

(B) Number of grants
A political subdivision or a consortium of
political subdivisions may not receive more
than one grant under paragraph (1).
(c) Applications for grants
A grant may be made under subsection (a) or
(b) of this section only if an application for the
grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances,
and information as the Secretary determines to
be necessary to carry out this section.
(d) Technical assistance
Amounts appropriated under subsection (f) of
this section may be used by the Secretary to
provide training and technical assistance with
respect to the planning, development, and operation of assessments and plans under subsection
(a) of this section and control programs under
subsection (b) of this section. The Secretary
may provide such technical assistance directly
or through awards of grants or contracts to public and private entities.
(e) Definition of political subdivision
In this section, the term ‘‘political subdivision’’ means the local political jurisdiction immediately below the level of State government,
including counties, parishes, and boroughs. If
State law recognizes an entity of general government that functions in lieu of, and is not
within, a county, parish, or borough, the Secretary may recognize an area under the jurisdiction of such other entities of general government as a political subdivision for purposes of
this section.
(f) Authorization of appropriations
(1) In general
For the purpose of carrying out this section,
there are authorized to be appropriated
$100,000,000 for fiscal year 2003, and such sums
as may be necessary for each of fiscal years
2004 through 2007.
(2) Public health emergencies
In the case of control programs carried out
in response to a mosquito-borne disease that
constitutes a public health emergency, the authorization of appropriations under paragraph
(1) is in addition to applicable authorizations
of appropriations under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
(3) Fiscal year 2004 appropriations
For fiscal year 2004, 50 percent or more of
the funds appropriated under paragraph (1)
shall be used to award grants to political subdivisions or consortia of political subdivisions
under subsection (b) of this section.
(July 1, 1944, ch. 373, title III, § 317S, as added
Pub. L. 108–75, § 2(2), Aug. 15, 2003, 117 Stat. 898.)
REFERENCES IN TEXT
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, referred to in subsec. (f)(2), is Pub. L. 107–188, June 12, 2002, 116 Stat. 594,
as amended. For complete classification of this Act to
the Code, see Short Title of 2002 Amendments note set
out under section 201 of this title and Tables.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 247b–22. Microbicide research
(a) In general
The Director of the Centers for Disease Control and Prevention is strongly encouraged to
fully implement the Centers’ microbicide agenda to support research and development of
microbicides for use to prevent the transmission
of the human immunodeficiency virus.
(b) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2009 through 2013 to carry out this section.
(July 1, 1944, ch. 373, title III, § 317T, as added
Pub. L. 110–293, title II, § 203(d), July 30, 2008, 122
Stat. 2941.)
§ 247c. Sexually transmitted diseases; prevention
and control projects and programs
(a) Technical assistance to public and nonprofit
private entities and scientific institutions
The Secretary may provide technical assistance to appropriate public and nonprofit private
entities and to scientific institutions for their
research in, and training and public health programs for, the prevention and control of sexually transmitted diseases.
(b) Research, demonstration, and public information and education projects
The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—
(1) research into the prevention and control
of sexually transmitted diseases;
(2) demonstration projects for the prevention and control of sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such
diseases; and
(4) education, training, and clinical skills
improvement activities in the prevention and
control of such diseases for health professionals (including allied health personnel).
(c) Project grants to States
The Secretary is also authorized to make project grants to States and, in consultation with
the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting,
screening, and followup of diagnostic tests for,
and diagnosed cases of, sexually transmitted
diseases;
(2) casefinding and case followup activities
respecting sexually transmitted diseases, including contact tracing of infectious cases of
sexually transmitted diseases and routine
testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to
evaluate or test sexually transmitted diseases
prevention and control strategies and activities as may be prescribed by the Secretary.

§ 247c

(d) Grants for innovative, interdisciplinary approaches
The Secretary may make grants to States and
political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases.
(e) Authorization of appropriations; terms and
conditions; payments; recordkeeping; audit;
grant reduction; information disclosure
(1) For the purpose of making grants under
subsections (b) through (d) of this section, there
are authorized to be appropriated $85,000,000 for
fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through
1998.
(2) Each recipient of a grant under this section
shall keep such records as the Secretary shall
prescribe, including records which fully disclose
the amount and disposition by such recipient of
the proceeds of such grant, the total cost of the
project or undertaking in connection with which
such grant was given or used, and the amount of
that portion of the cost of the project or undertaking supplied by other sources, and such other
records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General
of the United States, or any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any
books, documents, papers, and records of the recipients of grants under this section that are
pertinent to such grants.
(4) The Secretary, at the request of a recipient
of a grant under this section, may reduce such
grant by the fair market value of any supplies or
equipment furnished to such recipient and by
the amount of pay, allowances, travel expenses,
and any other costs in connection with the detail of an officer or employee of the United
States to the recipient when the furnishing of
such supplies or equipment or the detail of such
an officer or employee is for the convenience of
and at the request of such recipient and for the
purpose of carrying out the program with respect to which the grant under this section is
made. The amount by which any such grant is so
reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the
supplies, equipment, or personal services on
which the reduction of such grant is based.
(5) All information obtained in connection
with the examination, care, or treatment of any
individual under any program which is being
carried out with a grant made under this section
shall not, without such individual’s consent, be
disclosed except as may be necessary to provide
service to him or as may be required by a law of
a state or political subdivision of a State. Information derived from any such program may be
disclosed—
(A) in summary, statistical, or other form;
or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided care or treatment under such
program is not disclosed.

§ 247c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Consent of individuals
Nothing in this section shall be construed to
require any State or any political subdivision of
a State to have a sexually transmitted diseases
program which would require any person, who
objects to any treatment provided under such a
program, to be treated under such a program.
(July 1, 1944, ch. 373, title III, § 318, as added Pub.
L. 92–449, title II, § 203, Sept. 30, 1972, 86 Stat. 751;
amended Pub. L. 94–317, title II, § 203(b)–(i), June
23, 1976, 90 Stat. 704, 705; Pub. L. 94–484, title IX,
§ 905(b)(2), Oct. 12, 1976, 90 Stat. 2325; Pub. L.
95–626, title II, § 204(b)(1), (c), (d), Nov. 10, 1978, 92
Stat. 3583; Pub. L. 96–32, § 6(j), July 10, 1979, 93
Stat. 84; Pub. L. 97–35, title IX, § 929, Aug. 13,
1981, 95 Stat. 569; Pub. L. 98–555, § 3, Oct. 30, 1984,
98 Stat. 2854; Pub. L. 100–607, title III, § 311, Nov.
4, 1988, 102 Stat. 3112; Pub. L. 103–183, title IV,
§ 401, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 105–392,
title IV, § 401(b)(2), (c), Nov. 13, 1998, 112 Stat.
3587.)
PRIOR PROVISIONS
A prior section 247c, act July 1, 1944, ch. 373 title III,
§ 318, as added Aug. 18, 1964, Pub. L. 88–443, § 2, 78 Stat.
447, related to grants for assisting in the areawide planning of health and related facilities, prior to repeal by
Pub. L. 89–749, § 6, Nov. 3, 1966, 80 Stat. 1190 eff. July 1,
1967.
AMENDMENTS
1998—Subsec. (e). Pub. L. 105–392, § 401(b)(2), redesignated subsec. (e), relating to consent of individuals, as
(f).
Subsec. (e)(5). Pub. L. 105–392, § 401(c), made technical
amendment to directory language of Pub. L. 103–183,
§ 401(c)(3). See 1993 Amendment note below.
Subsec. (f). Pub. L. 105–392, § 401(b)(2), redesignated
subsec. (e), relating to consent of individuals, as (f).
1993—Subsec. (b)(3). Pub. L. 103–183, § 401(c)(1), substituted ‘‘; and’’ for ‘‘, and’’.
Subsec. (c)(3). Pub. L. 103–183, § 401(c)(2), which directed the substitution of ‘‘; and’’ for ‘‘, and’’, could
not be executed because ‘‘, and’’ did not appear.
Subsec. (d). Pub. L. 103–183, § 401(a)(2), added subsec.
(d). Former subsec. (d) redesignated (e).
Subsec. (e). Pub. L. 103–183, § 401(a)(1), redesignated
subsec. (d), relating to authorization of appropriations,
etc., as (e).
Subsec. (e)(1). Pub. L. 103–183, § 401(b), amended par.
(1) generally. Prior to amendment, par. (1) read as follows: ‘‘For the purpose of making grants under subsections (b) and (c) of this section there are authorized
to be appropriated $45,000,000 for the fiscal year ending
September 30, 1979, $51,500,000 for the fiscal year ending
September 30, 1980, $59,000,000 for the fiscal year ending
September 30, 1981, $40,000,000 for the fiscal year ending
September 30, 1982, $46,500,000 for the fiscal year ending
September 30, 1983, $50,000,000 for the fiscal year ending
September 30, 1984, $57,000,000 for the fiscal year ending
September 30, 1985, $62,500,000 for the fiscal year ending
September 30, 1986, $68,000,000 for the fiscal year ending
September 30, 1987, $78,000,000 for fiscal year 1989, and
such sums as may be necessary for each of the fiscal
years 1990 and 1991. For grants under subsection (b) of
this section in any fiscal year, the Secretary shall obligate not less than 10 per centum of the amount appropriated for such fiscal year under the preceding sentence. Grants made under subsection (b) or (c) of this
section shall be made on such terms and conditions as
the Secretary finds necessary to carry out the purposes
of such subsection, and payments under any such
grants shall be made in advance or by way of reimbursement and in such installments as the Secretary
finds necessary.’’
Subsec. (e)(5). Pub. L. 103–183, § 401(c)(3), as amended
by Pub. L. 105–392, § 401(c), substituted ‘‘form; or’’ for

Page 188

‘‘form, or’’ in subpar. (A) and ‘‘purposes;’’ for ‘‘purposes,’’ in subpar. (B).
1988—Pub. L. 100–607, § 311(1), amended section catchline.
Subsec. (d). Pub. L. 100–607, § 311(2), (3), redesignated
subsec. (e) as (d) and struck out former subsec. (d)
which related to acquired immune deficiency syndrome.
Subsec. (d)(1). Pub. L. 100–607, § 311(4), substituted ‘‘(b)
and (c)’’ for ‘‘(b), (c), and (d)’’, struck out ‘‘and’’ after
‘‘1986,’’, and inserted ‘‘, $78,000,000 for fiscal year 1989,
and such sums as may be necessary for each of the fiscal years 1990 and 1991’’ before period at end of first sentence; substituted ‘‘(b) or (c)’’ for ‘‘(b), (c), or (d)’’ in
third sentence; and struck out at end ‘‘If the appropriations under the first sentence for fiscal year 1985 exceed
$50,000,000, one-half of the amount in excess of
$50,000,000 shall be made available for grants under subsection (d) of this section; if the appropriations under
the first sentence for fiscal year 1986 exceed $52,500,000,
one-half of the amount in excess of $52,500,000 shall be
made available for such grants; and if the appropriations under the first sentence for fiscal year 1987 exceed
$55,000,000, one-half of the amount in excess of
$55,000,000 shall be made available for such grants.’’
Subsecs. (e) to (g). Pub. L. 100–607, § 311(2), (3), struck
out subsec. (f) which related to conditional limitation
on use of funds and redesignated subsecs. (e) and (g) as
(d) and (e), respectively.
1984—Subsec. (a). Pub. L. 98–555, § 3(b)(1), substituted
‘‘research in, and training and public health programs
for, the prevention and control of sexually transmitted
diseases’’ for ‘‘research, training, and public health programs for the prevention and control of venereal disease’’.
Subsec. (b). Pub. L. 98–555, § 3(b)(2), in amending subsec. (b) generally, designated existing provisions as
pars. (1) to (3), added par. (4), and substituted references
to sexually transmitted diseases for reference to venereal disease.
Subsec. (c). Pub. L. 98–555, § 3(b)(3), (6)(A), substituted
‘‘sexually transmitted diseases’’ for ‘‘venereal disease’’
wherever appearing, struck out par. (4) relating to professional venereal disease education, training and clinical skills improvement activities, and redesignated par.
(5) as (4).
Subsec. (d). Pub. L. 98–555, § 3(b)(5)(A), added subsec.
(d). Former subsec. (d) redesignated (e).
Subsec. (e). Pub. L. 98–555, § 3(a), (b)(4), (5), redesignated subsec. (d) as (e), and in par. (1) of subsec. (e) as
so redesignated, substituted ‘‘(b), (c), and (d)’’ for ‘‘(b)
and (c)’’, inserted provisions authorizing appropriations
for fiscal years ending Sept. 30, 1985, 1986, and 1987, substituted ‘‘10 per centum’’ for ‘‘5 per centum’’, and inserted provisions directing that one-half the excess of
appropriations in fiscal years 1985, 1986, and 1987 over
certain amounts be made available for grants under
subsec. (d). Notwithstanding language of section
3(b)(5)(B)(ii) directing the substitution of ‘‘(b), (c), or
(d)’’ for ‘‘(b) or (c)’’ in second sentence of subsec. (e)(1),
the amendment was executed by making the substitution in third sentence of subsec. (e)(1) to reflect the
probable intent of Congress because ‘‘(b) or (c)’’ did not
appear in second sentence. Former subsec. (e) redesignated (f).
Subsecs. (f), (g). Pub. L. 98–555, § 3(b)(5)(A), (6)(A), (C),
redesignated subsecs. (e) and (f) as (f) and (g), respectively, in subsecs. (f) and (g) as so redesignated, substituted ‘‘sexually transmitted diseases’’ for ‘‘venereal
disease’’, and struck out former subsec. (g) which defined venereal disease.
1981—Subsec. (d)(1). Pub. L. 97–35 inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1982, 1983, and 1984.
1979—Subsec. (b). Pub. L. 96–32 amended directory
language of Pub. L. 95–626, § 204(c)(2), and required no
change in text. See 1978 Amendment note below.
1978—Subsec. (b). Pub. L. 95–626, § 204(c)(2), as amended by Pub. L. 96–32, substituted ‘‘research, demonstrations, and public information and education for the pre-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

vention and control of venereal disease’’ for ‘‘research,
demonstrations, education, and training for the prevention and control of venereal disease’’, struck out ‘‘(1)’’
preceding provisions thus amended, and struck out par.
(2) which authorized appropriation of $5,000,000 for fiscal year 1976, $6,600,000 for fiscal year 1977, and $7,600,000
for fiscal year 1978 for purpose of carrying out this subsection.
Subsec. (c). Pub. L. 95–626, § 204(d), struck out ‘‘(1)’’
after ‘‘(c)’’ at beginning of existing provisions, changed
designations at beginning of each of the five clauses
from ‘‘(A)’’, ‘‘(B)’’, ‘‘(C)’’, ‘‘(D)’’, and ‘‘(E)’’ to ‘‘(1)’’,
‘‘(2)’’, ‘‘(3)’’, ‘‘(4)’’, and ‘‘(5)’’, respectively, substituted
‘‘The Secretary is also authorized’’ for ‘‘The Secretary
is authorized’’ in provisions preceding cl. (1) as redesignated, substituted ‘‘professional (including appropriate
allied health personnel) venereal disease education,
training and clinical skills improvement activities’’ for
‘‘professional and public venereal disease education activities’’ in cl. (4) as redesignated, and struck out
former par. (2) which had authorized appropriations of
$32,000,000 for fiscal year 1976, $41,500,000 for fiscal year
1977, and $43,500,000 for fiscal year 1978.
Subsec. (d)(1). Pub. L. 95–626, § 204(c)(1), inserted provisions authorizing appropriations of $45,000,000 for fiscal year ending Sept. 30, 1979, $51,500,000 for fiscal year
ending Sept. 30, 1980, and $59,000,000 for fiscal year ending Sept. 30, 1981, for purpose of making grants under
subsecs. (b) and (c) of this section, and inserted provisions directing Secretary to obligate not less than 5 per
centum of amount appropriated for any fiscal year.
Subsec. (f). Pub. L. 95–626, § 204(b)(1), redesignated
subsec. (g) as (f). Former subsec. (f), requiring that not
to exceed 50 per centum of amounts appropriated for
any fiscal year under subsecs. (b) and (c) of this section
could be used by Secretary for grants for such fiscal
year under section 247b of this title, was struck out.
Subsec. (g). Pub. L. 95–626, § 204(b)(1), redesignated
subsec. (h) as (g). Former subsec. (g) redesignated (f).
1976—Subsec. (a). Pub. L. 94–317, § 203(c), substituted
‘‘public and nonprofit private entities and to’’ for ‘‘public authorities and’’.
Subsec. (b)(1). Pub. L. 94–317, § 203(i), inserted ‘‘education,’’ before ‘‘and training’’.
Subsec. (b)(2). Pub. L. 94–317, § 203(b)(1), substituted
provisions authorizing appropriations of $5,000,000 for
fiscal year 1976, $6,600,000 for fiscal year 1977, and
$7,600,000 for fiscal year 1978, for provisions authorizing
appropriations of $7,500,000 for fiscal year ending June
30, 1973, and for each of the next two fiscal years.
Subsec. (c). Pub. L. 94–484, purported to amend former
subsec. (c)(1) by defining ‘‘State’’ to include the Northern Mariana Islands. Former subsec. (c) of this section
had been previously repealed by section 203(f)(1) of Pub.
L. 94–317. See par. below.
Pub. L. 94–317, § 203(b)(2), (d), (e), (f)(1), (3), (8), redesignated subsec. (d) as (c), inserted, in par. (1)(B), reference to routine testing, including laboratory tests
and followup systems and substituted in par. (1)(E).
‘‘prevention and control strategies and activities’’ for
‘‘control’’ and, in par. (2), provisions authorizing appropriations of $32,000,000 for fiscal year 1976, $41,500,000 for
fiscal year 1977, and $43,500,000 for fiscal year 1978, for
provisions authorizing appropriations of $30,000,000 for
the fiscal year ending June 30, 1973, and for each of the
next two succeeding fiscal years. Former subsec. (c),
which provided for authorization of appropriations to
enable the Secretary to make grants to state health
authorities to establish and maintain programs for diagnosis and treatment of venereal disease was amended
by striking out reference to dark-field microscope techniques for diagnosis of both gonorrhea an syphilis, and
as so amended, was repealed.
Subsec. (d). Pub. L. 94–317, § 203(f)(2), (4), (5), (8), redesignated subsec. (e) as (d), substituted in par. (1) ‘‘or (c)’’
for ‘‘or (d)’’, struck out in par. (4) provisions relating to
the amount of reduction of a grant under former subsec. (c) whereby such amount shall be deemed a part of
the grant to the recipient of the grant and shall be
deemed to have been paid to such recipient, and in-

§ 247c

serted in par. (5) reference to requirement by law of a
State or political subdivision of a state. Former subsec.
(d) redesignated (c).
Subsec. (e). Pub. L. 94–317, § 203(f)(8), (g), redesignated
subsec. (f) as (e) and substituted ‘‘247b(g)(2) of this
title’’ for ‘‘247b(d)(4) of this title’’. Former subsec. (e)
redesignated (d).
Subsec. (f). Pub. L. 94–317, § 203(f)(6), (8), redesignated
subsec. (g) as (f) and substituted ‘‘and (c)’’ for ‘‘, (c),
and (d)’’. Former subsec. (f) redesignated (e).
Subsec. (g). Pub. L. 94–317, § 203(f)(7), (8), redesignated
subsec. (h) as (g) and struck out ‘‘treated or to have
any child or ward of his’’ after ‘‘a program, to be’’.
Former subsec. (g) redesignated (f).
Subsec. (h). Pub. L. 94–317, § 203(h), added subsec. (h).
Former subsec. (h) redesignated (g).
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.
DISTRIBUTION OF INFORMATION ON ACQUIRED IMMUNE
DEFICIENCY SYNDROME BY DIRECTOR OF CENTERS FOR
DISEASE CONTROL TO EVERY AMERICAN HOUSEHOLD
Pub. L. 100–202, § 101(h) [title II], Dec. 22, 1987, 101
Stat. 1329–256, 1329–365, provided: ‘‘That the Director
shall cause to be distributed without necessary clearance of the content by any official, organization or office, an AIDS mailer to every American household by
June 30, 1988, as approved and funded by the Congress
in Public Law 100–71 [July 11, 1987, 101 Stat. 391].’’
CONGRESSIONAL FINDINGS AND DECLARATIONS
Section 204(a) of Pub. L. 95–626 provided that: ‘‘The
Congress finds and declares that—
‘‘(1) the number of reported cases of venereal disease persists in epidemic proportions in the United
States;
‘‘(2) the number of persons affected by venereal disease and reported to public health authorities is only
a fraction of those actually affected;
‘‘(3) the incidence of venereal disease continues to
be particularly high among American youth, ages fifteen to twenty-nine, and among populations in metropolitan areas;
‘‘(4) venereal disease accounts for severe permanent
disabilities and sometimes death in newborns and
causes reproductive dysfunction in women of childbearing age;
‘‘(5) it is conservatively estimated that the public
cost of health care for persons suffering from complications of venereal disease exceeds one-half billion
dollars annually;
‘‘(6) the number of trained Federal venereal disease
prevention and control personnel has fallen to a dangerously inadequate level;
‘‘(7) no vaccine for syphilis, gonorrhea, or any other
venereal disease has yet been developed, nor does a
blood test for the detection of asymptomatic gonorrhea in women exist, nor are safe and effective therapeutic agents available for some other venereal diseases;
‘‘(8) school health education programs, public information and awareness campaigns, mass diagnostic
screening and case followup have all been found to be
effective venereal disease prevention and control
methodologies;
‘‘(9) skilled and knowledgeable health care providers, informed and concerned individuals and active,
well-coordinated voluntary groups are fundamental
to venereal disease prevention and control;
‘‘(10) biomedical research toward improved diagnostic and therapeutic tools is of singular importance
to the elimination of venereal disease; and
‘‘(11) an increasing number of sexually transmissible diseases besides syphilis and gonorrhea have
become a public health hazard.’’

§ 247c–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 203(a) of Pub. L. 94–317 provided that: ‘‘The
Congress finds and declares that—
‘‘(1) the number of reported cases of venereal disease continues in epidemic proportions in the United
States;
‘‘(2) the number of patients with venereal disease
reported to public health authorities is only a fraction of those actually infected;
‘‘(3) the incidence of venereal disease is particularly
high in the 15–29-year age group, and in metropolitan
areas;
‘‘(4) venereal disease accounts for needless deaths
and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
‘‘(5) the number of cases of congenital syphilis, a
preventable disease, tends to parallel the incidence of
syphilis in adults;
‘‘(6) it is conservatively estimated that the public
cost of care for persons suffering the complications of
venereal disease exceed $80,000,000 annually;
‘‘(7) medical researchers have no successful vaccine
for syphilis or gonorrhea, and have no blood test for
the detection of gonorrhea among the large reservoir
of asymptomatic females;
‘‘(8) school health education programs, public information and awareness campaigns, mass diagnostic
screening and case followup activities have all been
found to be effective disease intervention methodologies;
‘‘(9) knowledgeable health providers and concerned
individuals and groups are fundamental to venereal
disease prevention and control;
‘‘(10) biomedical research leading to the development of vaccines for syphilis and gonorrhea is of singular importance for the eventual eradication of
these dreaded diseases; and
‘‘(11) a variety of other sexually transmitted diseases, in addition to syphilis and gonorrhea, have become of public health significance.’’
Section 202 of Pub. L. 92–449 provided that:
‘‘(a) The Congress finds and declares that—
‘‘(1) the number or reported cases of venereal disease has reached epidemic proportions in the United
States;
‘‘(2) the number of patients with venereal disease
reported to public health authorities is only a fraction of those treated by physicians;
‘‘(3) the incidence of venereal disease is particularly
high among individuals in the 20–24 age group, and in
metropolitan areas;
‘‘(4) venereal disease accounts for needless deaths
and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
‘‘(5) the number of cases of congenital syphilis, a
preventable disease, in infants under one year of age
increased by 331⁄3 per centum between 1970 and 1971;
‘‘(6) health education programs in schools and
through the mass media may prevent a substantial
portion of the venereal disease problem; and
‘‘(7) medical authorities have no successful vaccine
for syphilis or gonorrhea and no blood test for the detection of gonorrhea among the large reservoir of
asymptomatic females.
‘‘(b) In order to preserve and protect the health and
welfare of all citizens, it is the purpose of this Act [this
chapter] to establish a national program for the prevention and control of venereal disease.’’

§ 247c–1. Infertility and sexually transmitted diseases
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to States, political subdivisions of States, and other public or nonprofit
private entities for the purpose of carrying out
the activities described in subsection (c) of this
section regarding any treatable sexually trans-

Page 190

mitted disease that can cause infertility in
women if treatment is not received for the disease.
(b) Authority regarding individual diseases
With respect to diseases described in subsection (a) of this section, the Secretary shall,
in making a grant under such subsection, specify the particular disease or diseases with respect
to which the grant is to be made. The Secretary
may not make the grant unless the applicant involved agrees to carry out this section only with
respect to the disease or diseases so specified.
(c) Authorized activities
With respect to any sexually transmitted disease described in subsection (a) of this section,
the activities referred to in such subsection
are—
(1) screening women for the disease and for
secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f) of this section;
(2) providing treatment to women for the
disease;
(3) providing counseling to women on the
prevention and control of the disease (including, in the case of a woman with the disease,
counseling on the benefits of locating and providing such counseling to any individual from
whom the woman may have contracted the
disease and any individual whom the woman
may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services
for women screened pursuant to paragraph (1),
including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through
(5), providing to the partner of the woman the
services described in such paragraphs, as appropriate;
(7) providing outreach services to inform
women of the availability of the services described in paragraphs (1) through (6);
(8) providing to the public information and
education on the prevention and control of the
disease, including disseminating such information; and
(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).
(d) Requirement of availability of all services
through each grantee
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees that each activity authorized in
subsection (c) of this section will be available
through the applicant. With respect to compliance with such agreement, the applicant may
expend the grant to carry out any of the activities directly, and may expend the grant to enter
into agreements with other public or nonprofit
private entities under which the entities carry
out the activities.
(e) Required providers regarding certain services
The Secretary may make a grant under subsection (a) of this section only if the applicant

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

involved agrees that, in expending the grant to
carry out activities authorized in subsection (c)
of this section, the services described in paragraphs (1) through (7) of such subsection will be
provided only through entities that are State or
local health departments, grantees under section 254b, 254b, 256a, or 300 of this title,1 or are
other public or nonprofit private entities that
provide health services to a significant number
of low-income women.
(f) Quality assurance regarding screening for
diseases
For purposes of this section, the Secretary
shall establish criteria for ensuring the quality
of screening procedures for diseases described in
subsection (a) of this section.
(g) Confidentiality
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees, subject to applicable law, to
maintain the confidentiality of information on
individuals with respect to activities carried out
under subsection (c) of this section.
(h) Limitation on imposition of fees for services
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees that, if a charge is imposed for
the provision of services or activities under the
grant, such charge—
(1) will be made according to a schedule of
charges that is made available to the public;
(2) will be adjusted to reflect the income of
the individual involved; and
(3) will not be imposed on any individual
with an income of less than 150 percent of the
official poverty line, as established by the Director of the Office of Management and Budget
and revised by the Secretary in accordance
with section 9902(2) of this title.
(i) Limitations on certain expenditures
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees that not less than 80 percent of
the grant will be expended for the purpose of
carrying out paragraphs (1) through (7) of subsection (c) of this section.
(j) Reports to Secretary
(1) Collection of data
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees, with respect to any disease
selected under subsection (b) of this section
for the applicant, to submit to the Secretary,
for each fiscal year for which the applicant receives such a grant, a report providing—
(A) the incidence of the disease among the
population of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided by the applicant, and the
health conditions with respect to which referrals have been made pursuant to subsection (c)(5) of this section;
1 See

References in Text notes below.

§ 247c–1

(D) an assessment of the extent to which
the activities carried pursuant to subsection
(a) of this section have reduced the incidence
of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the
project carried out with the grant.
(2) Utility and comparability of data
The Secretary shall carry out activities for
the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1).
(k) Maintenance of effort
With respect to activities for which a grant
under subsection (a) of this section is authorized
to be expended, the Secretary may make such a
grant only if the applicant involved agrees to
maintain expenditures of non-Federal amounts
for such activities at a level that is not less than
the average level of such expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is
applying to receive such a grant.
(l) Requirement of application
(1) In general
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is
in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary determines to be
necessary to carry out this section.
(2) Submission of plan for program of grantee
(A) In general
The Secretary may make a grant under
subsection (a) of this section only if the applicant involved submits to the Secretary a
plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a
grant, including a specification of the entities through which activities authorized in
subsection (c) of this section will be provided.
(B) Participation of certain entities
The Secretary may make a grant under
subsection (a) of this section only if the applicant provides assurances satisfactory to
the Secretary that the plan submitted under
subparagraph (A) has been prepared in consultation with an appropriate number and
variety of—
(i) representatives of entities in the geographic area involved that provide services
for the prevention and control of sexually
transmitted diseases, including programs
to provide to the public information and
education regarding such diseases; and
(ii) representatives of entities in such
area that provide family planning services.
(m) Duration of grant
The period during which payments are made
to an entity from a grant under subsection (a) of

§ 247c–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this section may not exceed 3 years. The provision of such payments shall be subject to annual
approval by the Secretary of the payments and
subject to the availability of appropriations for
the fiscal year involved to make the payments
in such year. The preceding sentence may not be
construed to establish a limitation on the number of grants under such subsection that may be
made to an entity.
(n) Technical assistance, and supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and
technical assistance to grantees under subsection (a) of this section with respect to the
planning, development, and operation of any
program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or
contracts.
(2) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient
of a grant under subsection (a) of this section,
may reduce the amount of such grant by—
(A) the fair market value of any supplies
or equipment furnished the grant recipient;
and
(B) the amount of the pay, allowances, and
travel expenses of any officer or employee of
the Government when detailed to the grant
recipient and the amount of any other costs
incurred in connection with the detail of
such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to
which the grant under subsection (a) of this
section is made. The amount by which any
such grant is so reduced shall be available for
payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which
the reduction of such grant is based, and such
amount shall be deemed as part of the grant
and shall be deemed to have been paid to the
grant recipient.
(o) Evaluations and reports by Secretary
(1) Evaluations
The Secretary shall, directly or through
contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) of this section in order to determine the quality and effectiveness of the programs.
(2) Report to Congress
Not later than 1 year after the date on which
amounts are first appropriated pursuant to
subsection (q) of this section, and biennially
thereafter, the Secretary shall submit to the
Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—
(A) summarizing the information provided
to the Secretary in reports made pursuant to

Page 192

subsection (j)(1) of this section, including information on the incidence of sexually
transmitted diseases described in subsection
(a) of this section; and
(B) summarizing evaluations carried out
pursuant to paragraph (1) during the preceding fiscal year.
(p) Coordination of Federal programs
The Secretary shall coordinate the program
carried out under this section with any similar
programs administered by the Secretary (including coordination between the Director of the
Centers for Disease Control and Prevention and
the Director of the National Institutes of
Health).
(q) Authorization of appropriations
For the purpose of carrying out this section,
other than subsections (o) and (r) of this section,
there are authorized to be appropriated
$25,000,000 for fiscal year 1993, and such sums as
may be necessary for each of the fiscal years
1994 through 1998.
(r) Separate grants for research on delivery of
services
(1) In general
The Secretary may make grants for the purpose of conducting research on the manner in
which the delivery of services under subsection (a) of this section may be improved.
The Secretary may make such grants only to
grantees under such subsection and to public
and nonprofit private entities that are carrying out programs substantially similar to programs carried out under such subsection.
(2) Authorization of appropriations
For the purpose of carrying out paragraph
(1), there are authorized to be appropriated
such sums as may be necessary for each of the
fiscal years 1993 through 1998.
(July 1, 1944, ch. 373, title III, § 318A, as added
Pub. L. 102–531, title III, § 304, Oct. 27, 1992, 106
Stat. 3490; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub.
L. 103–183, title IV, § 402, Dec. 14, 1993, 107 Stat.
2236; Pub. L. 107–251, title VI, § 601(a), Oct. 26,
2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec.
6, 2003, 117 Stat. 2023.)
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing, referred to in subsec. (e), was in the
original a reference to section 329, meaning section 329
of act July 1, 1944, which was omitted in the general
amendment of subpart I (§ 254b et seq.) of part D of this
subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat.
3626.
Section 256a of this title, referred to in subsec. (e),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.
AMENDMENTS
2003—Subsec. (e). Pub. L. 108–163 substituted ‘‘254b’’
for ‘‘254c, 254b(h)’’ before ‘‘, 256a’’.
2002—Subsec. (e). Pub. L. 107–251 substituted ‘‘254b(h)’’
for ‘‘256’’.
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 304, which enacted
this section.
Subsec. (o)(2). Pub. L. 103–183, § 402(a), substituted
‘‘subsection (q)’’ for ‘‘subsection (s)’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (q). Pub. L. 103–183, § 402(b)(1), substituted
‘‘through 1998’’ for ‘‘and 1995’’.
Subsec. (r)(2). Pub. L. 103–183, § 402(b)(2), substituted
‘‘1998’’ for ‘‘1995’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 247c–2. Data collection regarding programs
under subchapter XXIV
For the purpose of collecting and providing
data for program planning and evaluation activities under subchapter XXIV of this chapter,
there are authorized to be appropriated to the
Secretary (acting through the Director of the
Centers for Disease Control and Prevention)
such sums as may be necessary for each of the
fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available
for such purpose.
(July 1, 1944, ch. 373, title III, § 318B, as added
Pub. L. 106–345, title IV, § 412, Oct. 20, 2000, 114
Stat. 1350.)
§ 247d. Public health emergencies
(a) Emergencies
If the Secretary determines, after consultation with such public health officials as may be
necessary, that—
(1) a disease or disorder presents a public
health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or
bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be
appropriate to respond to the public health
emergency, including making grants, providing
awards for expenses, and entering into contracts
and conducting and supporting investigations
into the cause, treatment, or prevention of a
disease or disorder as described in paragraphs (1)
and (2). Any such determination of a public
health emergency terminates upon the Secretary declaring that the emergency no longer
exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever
occurs first. Determinations that terminate
under the preceding sentence may be renewed by
the Secretary (on the basis of the same or addi-

§ 247d

tional facts), and the preceding sentence applies
to each such renewal. Not later than 48 hours
after making a determination under this subsection of a public health emergency (including
a renewal), the Secretary shall submit to the
Congress written notification of the determination.
(b) Public Health Emergency Fund
(1) In general
There is established in the Treasury a fund
to be designated as the ‘‘Public Health Emergency Fund’’ to be made available to the Secretary without fiscal year limitation to carry
out subsection (a) of this section only if a public health emergency has been declared by the
Secretary under such subsection. There is authorized to be appropriated to the Fund such
sums as may be necessary.
(2) Report
Not later than 90 days after the end of each
fiscal year, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the
Committee on Commerce and the Committee
on Appropriations of the House of Representatives a report describing—
(A) the expenditures made from the Public
Health Emergency Fund in such fiscal year;
and
(B) each public health emergency for
which the expenditures were made and the
activities undertaken with respect to each
emergency which was conducted or supported by expenditures from the Fund.
(c) Supplement not supplant
Funds appropriated under this section shall be
used to supplement and not supplant other Federal, State, and local public funds provided for
activities under this section.
(d) Data submittal and reporting deadlines
In any case in which the Secretary determines
that, wholly or partially as a result of a public
health emergency that has been determined pursuant to subsection (a) of this section, individuals or public or private entities are unable to
comply with deadlines for the submission to the
Secretary of data or reports required under any
law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require,
and may waive, wholly or partially, any sanctions otherwise applicable to such failure to
comply. Before or promptly after granting such
an extension or waiver, the Secretary shall notify the Congress of such action and publish in
the Federal Register a notice of the extension or
waiver.
(July 1, 1944, ch. 373, title III, § 319, as added Pub.
L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat.
2315; amended Pub. L. 107–188, title I, §§ 141,
144(a), 158, June 12, 2002, 116 Stat. 626, 630, 633.)
PRIOR PROVISIONS
A prior section 247d, act July 1, 1944, ch. 373, title III,
§ 319, as added Pub. L. 98–49, July 13, 1983, 97 Stat. 245;
amended Pub. L. 100–607, title II, § 256(a), Nov. 4, 1988,

§ 247d–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

102 Stat. 3110; Pub. L. 102–321, title I, § 163(b)(2), July 10,
1992, 106 Stat. 376; Pub. L. 102–531, title III, § 312(d)(2),
Oct. 27, 1992, 106 Stat. 3504, authorized the Secretary to
take appropriate action relating to public health emergencies, prior to repeal by Pub. L. 106–505, title I, § 102,
Nov. 13, 2000, 114 Stat. 2315.
Another prior section 247d, act July 1, 1944, ch. 373,
title III, § 319, formerly § 310, as added Sept. 25, 1962,
Pub. L. 87–692, 76 Stat. 592, and amended and renumbered, which related to migrant health centers, was renumbered section 329 of act July 1, 1944, by Pub. L.
95–626, title I, § 102(a), Nov. 10, 1978, 92 Stat. 3551, and
transferred to section 254b of this title, prior to being
omitted in the general amendment of subpart I (§ 254b
et seq.) of part D of this subchapter by Pub. L. 104–299,
§ 2.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
AMENDMENTS
2002—Subsec. (a). Pub. L. 107–188, § 158, substituted
‘‘grants, providing awards for expenses, and’’ for
‘‘grants and’’ in concluding provisions.
Pub. L. 107–188, § 144(a), inserted at end of concluding
provisions ‘‘Any such determination of a public health
emergency terminates upon the Secretary declaring
that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on
which the determination is made by the Secretary,
whichever occurs first. Determinations that terminate
under the preceding sentence may be renewed by the
Secretary (on the basis of the same or additional facts),
and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit
to the Congress written notification of the determination.’’
Subsec. (d). Pub. L. 107–188, § 141, added subsec. (d).
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107–188, title I, § 144(b), June 12, 2002, 116 Stat.
630, provided that: ‘‘The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public
Health Service Act [subsec. (a) of this section], including any such emergency that was in effect as of the day
before the date of the enactment of this Act [June 12,
2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such
section with respect to the termination of the emergency is deemed to begin on such date of enactment.’’

§ 247d–1. Vaccine tracking and distribution
(a) Tracking
The Secretary, together with relevant manufacturers, wholesalers, and distributors as may
agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic. Such tracking information shall be used to inform Federal,
State, local, and tribal decision makers during
an influenza pandemic.
(b) Distribution
The Secretary shall promote communication
between State, local, and tribal public health officials and such manufacturers, wholesalers, and
distributors as agree to participate, regarding
the effective distribution of seasonal influenza

Page 194

vaccine. Such communication shall include estimates of high priority populations, as determined by the Secretary, in State, local, and
tribal jurisdictions in order to inform Federal,
State, local, and tribal decision makers during
vaccine shortages and supply disruptions.
(c) Confidentiality
The information submitted to the Secretary
or its contractors, if any, under this section or
under any other section of this chapter related
to vaccine distribution information shall remain
confidential in accordance with the exception
from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section
552(b)(4) of title 5, and subject to the penalties
and exceptions under sections 1832 and 1833 of
title 18 relating to the protection and theft of
trade secrets, and subject to privacy protections
that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.
None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used
in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.
(d) Guidelines
The Secretary, in order to maintain the confidentiality of relevant information and ensure
that none of the information contained in the
systems involved may be used to provide proprietary advantage within the vaccine market,
while allowing State, local, and tribal health officials access to such information to maximize
the delivery and availability of vaccines to high
priority populations, during times of influenza
pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers,
distributors, wholesalers and State, local, and
tribal health departments, shall develop guidelines for subsections (a) and (b).
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, such sums for each of fiscal years 2007 through 2011.
(f) Report to Congress
As part of the National Health Security Strategy described in section 300hh–1 of this title, the
Secretary shall provide an update on the implementation of subsections (a) through (d).
(July 1, 1944, ch. 373, title III, § 319A, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2316; amended Pub. L. 107–188, title I,
§ 111(1), June 12, 2002, 116 Stat. 611; Pub. L.
109–417, title II, § 204(a), Dec. 19, 2006, 120 Stat.
2850.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (c), is
section 264(c) of Pub. L. 104–191, which is set out as a
note under section 1320d–2 of this title.
AMENDMENTS
2006—Pub. L. 109–417 amended section catchline and
text generally, substituting provisions relating to vac-

Page 195

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cine tracking and distribution for provisions relating
to establishment of capacities to combat threats to
public health.
2002—Subsec. (a)(1). Pub. L. 107–188 substituted ‘‘five
years’’ for ‘‘10 years’’.

§§ 247d–2, 247d–3. Repealed. Pub. L. 109–417, title
II, § 204(b)(1), Dec. 19, 2006, 120 Stat. 2851
Section 247d–2, act July 1, 1944, ch. 373, title III,
§ 319B, as added Pub. L. 106–505, title I, § 102, Nov. 13,
2000, 114 Stat. 2317; amended Pub. L. 107–188, title I,
§ 111(2), June 12, 2002, 116 Stat. 611, related to grants to
States to assess public health needs.
Section 247d–3, act July 1, 1944, ch. 373, title III,
§ 319C, as added Pub. L. 106–505, title I, § 102, Nov. 13,
2000, 114 Stat. 2317; amended Pub. L. 107–188, title I,
§ 131(b), June 12, 2002, 116 Stat. 626, related to grants to
improve State and local public health agencies.

§ 247d–3a. Improving State and local public
health security
(a) In general
To enhance the security of the United States
with respect to public health emergencies, the
Secretary shall award cooperative agreements
to eligible entities to enable such entities to
conduct the activities described in subsection
(d).
(b) Eligible entities
To be eligible to receive an award under subsection (a), an entity shall—
(1)(A) be a State;
(B) be a political subdivision determined by
the Secretary to be eligible for an award under
this section (based on criteria described in
subsection (i)(4)); or
(C) be a consortium of entities described in
subparagraph (A); and
(2) prepare and submit to the Secretary an
application at such time, and in such manner,
and containing such information as the Secretary may require, including—
(A) an All-Hazards Public Health Emergency Preparedness and Response Plan
which shall include—
(i) a description of the activities such entity will carry out under the agreement to
meet the goals identified under section
300hh–1 of this title;
(ii) a pandemic influenza plan consistent
with the requirements of paragraphs (2)
and (5) of subsection (g);
(iii) preparedness and response strategies
and capabilities that take into account the
medical and public health needs of at-risk
individuals in the event of a public health
emergency;
(iv) a description of the mechanism the
entity will implement to utilize the Emergency Management Assistance Compact or
other mutual aid agreements for medical
and public health mutual aid; and
(v) a description of how the entity will
include the State Unit on Aging in public
health emergency preparedness;
(B) an assurance that the entity will report to the Secretary on an annual basis (or
more frequently as determined by the Secretary) on the evidence-based benchmarks
and objective standards established by the

§ 247d–3a

Secretary to evaluate the preparedness and
response capabilities of such entity under
subsection (g);
(C) an assurance that the entity will conduct, on at least an annual basis, an exercise
or drill that meets any criteria established
by the Secretary to test the preparedness
and response capabilities of such entity, and
that the entity will report back to the Secretary within the application of the following year on the strengths and weaknesses
identified through such exercise or drill, and
corrective actions taken to address material
weaknesses;
(D) an assurance that the entity will provide to the Secretary the data described
under section 247d–4(d)(3) of this title as determined feasible by the Secretary;
(E) an assurance that the entity will conduct activities to inform and educate the
hospitals within the jurisdiction of such entity on the role of such hospitals in the plan
required under subparagraph (A);
(F) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement
an accountability system to ensure that
such entity make 1 satisfactory annual improvement and describe 2 such system in the
plan under subparagraph (A);
(G) a description of the means by which to
obtain public comment and input on the
plan described in subparagraph (A) and on
the implementation of such plan, that shall
include an advisory committee or other
similar mechanism for obtaining comment
from the public and from other State, local,
and tribal stakeholders; and
(H) as relevant, a description of the process used by the entity to consult with local
departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under
this section.
(c) Limitation
Beginning in fiscal year 2009, the Secretary
may not award a cooperative agreement to a
State unless such State is a participant in the
Emergency System for Advance Registration of
Volunteer Health Professionals described in section 247d–7b of this title.
(d) Use of funds
(1) In general
An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (2),
(4), (5), and (6) of section 300hh–1(b) of this
title.
(2) Effect of section
Nothing in this subsection may be construed
as establishing new regulatory authority or as
modifying any existing regulatory authority.
(e) Coordination with local response capabilities
An entity shall, to the extent practicable, ensure that activities carried out under an award
1 So
2 So

in original. Probably should be ‘‘makes’’.
in original. Probably should be ‘‘describes’’.

§ 247d–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

under subsection (a) are coordinated with activities of relevant Metropolitan Medical Response
Systems, local public health departments, the
Cities Readiness Initiative, and local emergency
plans.
(f) Consultation with Homeland Security
In making awards under subsection (a), the
Secretary shall consult with the Secretary of
Homeland Security to—
(1) ensure maximum coordination of public
health and medical preparedness and response
activities with the Metropolitan Medical Response System, and other relevant activities;
(2) minimize duplicative funding of programs
and activities;
(3) analyze activities, including exercises
and drills, conducted under this section to develop recommendations and guidance on best
practices for such activities; and
(4) disseminate such recommendations and
guidance, including through expanding existing lessons learned information systems to
create a single Internet-based point of access
for sharing and distributing medical and public health best practices and lessons learned
from drills, exercises, disasters, and other
emergencies.
(g) Achievement of measurable evidence-based
benchmarks and objective standards
(1) In general
Not later than 180 days after December 19,
2006, the Secretary shall develop or where appropriate adopt, and require the application
of, measurable evidence-based benchmarks and
objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in section 247d–3b of this
title. In developing such benchmarks and
standards, the Secretary shall consult with
and seek comments from State, local, and
tribal officials and private entities, as appropriate. Where appropriate, the Secretary shall
incorporate existing objective standards. Such
benchmarks and standards shall—
(A) include outcome goals representing
operational achievement of the National
Preparedness Goals developed under section
300hh–1(b) of this title; and
(B) at a minimum, require entities to—
(i) measure progress toward achieving
the outcome goals; and
(ii) at least annually, test, exercise, and
rigorously evaluate the public health and
medical emergency preparedness and response capabilities of the entity, and report to the Secretary on such measured
and tested capabilities and measured and
tested progress toward achieving outcome
goals, based on criteria established by the
Secretary.
(2) Criteria for pandemic influenza plans
(A) In general
Not later than 180 days after December 19,
2006, the Secretary shall develop and disseminate to the chief executive officer of
each State criteria for an effective State
plan for responding to pandemic influenza.

Page 196

(B) Rule of construction
Nothing in this section shall be construed
to require the duplication of Federal efforts
with respect to the development of criteria
or standards, without regard to whether
such efforts were carried out prior to or
after December 19, 2006.3
(3) Technical assistance
The Secretary shall, as determined appropriate by the Secretary, provide to a State,
upon request, technical assistance in meeting
the requirements of this section, including the
provision of advice by experts in the development of high-quality assessments, the setting
of State objectives and assessment methods,
the development of measures of satisfactory
annual improvement that are valid and reliable, and other relevant areas.
(4) Notification of failures
The Secretary shall develop and implement
a process to notify entities that are determined by the Secretary to have failed to meet
the requirements of paragraph (1) or (2). Such
process shall provide such entities with the
opportunity to correct such noncompliance.
An entity that fails to correct such noncompliance shall be subject to paragraph (5).
(5) Withholding of amounts from entities that
fail to achieve benchmarks or submit influenza plan
Beginning with fiscal year 2009, and in each
succeeding fiscal year, the Secretary shall—
(A) withhold from each entity that has
failed substantially to meet the benchmarks
and performance measures described in paragraph (1) for the immediately preceding fiscal year (beginning with fiscal year 2008),
pursuant to the process developed under
paragraph (4), the amount described in paragraph (6); and
(B) withhold from each entity that has
failed to submit to the Secretary a plan for
responding to pandemic influenza that meets
the criteria developed under paragraph (2),
the amount described in paragraph (6).
(6) Amounts described
(A) In general
The amounts described in this paragraph
are the following amounts that are payable
to an entity for activities described in this
section or section 247d–3b of this title:
(i) For the fiscal year immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5) by the entity, an amount equal to 10 percent of the
amount the entity was eligible to receive
for such fiscal year.
(ii) For the fiscal year immediately following two consecutive fiscal years in
which an entity experienced such a failure,
an amount equal to 15 percent of the
amount the entity was eligible to receive
for such fiscal year, taking into account
the withholding of funds for the immediately preceding fiscal year under clause
(i).
3 See

Codification note below.

Page 197

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iii) For the fiscal year immediately following three consecutive fiscal years in
which an entity experienced such a failure,
an amount equal to 20 percent of the
amount the entity was eligible to receive
for such fiscal year, taking into account
the withholding of funds for the immediately preceding fiscal years under
clauses (i) and (ii).
(iv) For the fiscal year immediately following four consecutive fiscal years in
which an entity experienced such a failure,
an amount equal to 25 percent of the
amount the entity was eligible to receive
for such a fiscal year, taking into account
the withholding of funds for the immediately preceding fiscal years under
clauses (i), (ii), and (iii).
(B) Separate accounting
Each failure described in subparagraph (A)
or (B) of paragraph (5) shall be treated as a
separate failure for purposes of calculating
amounts withheld under subparagraph (A).
(7) Reallocation of amounts withheld
(A) In general
The Secretary shall make amounts withheld under paragraph (6) available for making awards under section 247d–3b of this title
to entities described in subsection (b)(1) of
such section.
(B) Preference in reallocation
In making awards under section 247d–3b of
this title with amounts described in subparagraph (A), the Secretary shall give preference to eligible entities (as described in
section 247d–3b(b)(1) of this title) that are located in whole or in part in States from
which amounts have been withheld under
paragraph (6).
(8) Waive or reduce withholding
The Secretary may waive or reduce the
withholding described in paragraph (6), for a
single entity or for all entities in a fiscal year,
if the Secretary determines that mitigating
conditions exist that justify the waiver or reduction.
(h) Grants for real-time disease detection improvement
(1) In general
The Secretary may award grants to eligible
entities to carry out projects described under
paragraph (4).
(2) Eligible entity
For purposes of this section, the term ‘‘eligible entity’’ means an entity that is—
(A)(i) a hospital, clinical laboratory, university; or
(ii) a poison control center or professional
organization in the field of poison control;
and
(B) a participant in the network established under subsection 4 247d–4(d) of this
title.
(3) Application
Each eligible entity desiring a grant under
this subsection shall submit to the Secretary
4 So

in original. Probably should be ‘‘section’’.

§ 247d–3a

an application at such time, in such manner,
and containing such information as the Secretary may require.
(4) Use of funds
(A) In general
An eligible entity described in paragraph
(2)(A)(i) that receives a grant under this subsection shall use the funds awarded pursuant
to such grant to carry out a pilot demonstration project to purchase and implement the use of advanced diagnostic medical
equipment to analyze real-time clinical
specimens for pathogens of public health or
bioterrorism significance and report any results from such project to State, local, and
tribal public health entities and the network
established under section 247d–4(d) of this
title.
(B) Other entities
An eligible entity described in paragraph
(2)(A)(ii) that receives a grant under this
section shall use the funds awarded pursuant
to such grant to—
(i) improve the early detection, surveillance, and investigative capabilities of poison control centers for chemical, biological, radiological, and nuclear events by
training poison information personnel to
improve the accuracy of surveillance data,
improving the definitions used by the poison control centers for surveillance, and
enhancing timely and efficient investigation of data anomalies;
(ii) improve the capabilities of poison
control centers to provide information to
health care providers and the public with
regard to chemical, biological, radiological, or nuclear threats or exposures, in
consultation with the appropriate State,
local, and tribal public health entities; or
(iii) provide surge capacity in the event
of a chemical, biological, radiological, or
nuclear event through the establishment
of alternative poison control center worksites and the training of nontraditional
personnel.
(i) Funding
(1) Authorization of appropriations
(A) In general
For the purpose of carrying out this section, there is authorized to be appropriated
$824,000,000 for fiscal year 2007, of which
$35,000,000 shall be used to carry out subsection (h), for awards pursuant to paragraph (3) (subject to the authority of the
Secretary to make awards pursuant to paragraphs (4) and (5)), and such sums as may be
necessary for each of fiscal years 2008
through 2011.
(B) Coordination
There are authorized to be appropriated,
$10,000,000 for fiscal year 2007 to carry out
subsection (f)(4) of this section and section
300hh–16 of this title.
(C) Requirement for State matching funds
Beginning in fiscal year 2009, in the case of
any State or consortium of two or more

§ 247d–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

States, the Secretary may not award a cooperative agreement under this section unless
the State or consortium of States agree
that, with respect to the amount of the cooperative agreement awarded by the Secretary, the State or consortium of States
will make available (directly or through donations from public or private entities) nonFederal contributions in an amount equal
to—
(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of
such costs ($1 for each $20 of Federal funds
provided in the cooperative agreement);
and
(ii) for any second fiscal year of the cooperative agreement, and for any subsequent fiscal year of such cooperative
agreement, not less than 10 percent of such
costs ($1 for each $10 of Federal funds provided in the cooperative agreement).
(D) Determination of amount of non-Federal
contributions
As determined by the Secretary, non-Federal contributions required in subparagraph
(C) may be provided directly or through donations from public or private entities and
may be in cash or in kind, fairly evaluated,
including plant, equipment or services.
Amounts provided by the Federal government, or services assisted or subsidized to
any significant extent by the Federal government, may not be included in determining the amount of such non-Federal contributions.
(2) Maintaining State funding
(A) In general
An entity that receives an award under
this section shall maintain expenditures for
public health security at a level that is not
less than the average level of such expenditures maintained by the entity for the preceding 2 year period.
(B) Rule of construction
Nothing in this section shall be construed
to prohibit the use of awards under this section to pay salary and related expenses of
public health and other professionals employed by State, local, or tribal public
health agencies who are carrying out activities supported by such awards (regardless of
whether the primary assignment of such personnel is to carry out such activities).
(3) Determination of amount
(A) In general
The Secretary shall award cooperative
agreements under subsection (a) to each
State or consortium of 2 or more States that
submits to the Secretary an application that
meets the criteria of the Secretary for the
receipt of such an award and that meets
other implementation conditions established
by the Secretary for such awards.
(B) Base amount
In determining the amount of an award
pursuant to subparagraph (A) for a State,
the Secretary shall first determine an

Page 198

amount the Secretary considers appropriate
for the State (referred to in this paragraph
as the ‘‘base amount’’), except that such
amount may not be greater than the minimum amount determined under subparagraph (D).
(C) Increase on basis of population
After determining the base amount for a
State under subparagraph (B), the Secretary
shall increase the base amount by an
amount equal to the product of—
(i) the amount appropriated under paragraph (1)(A)(i)(I) 5 for the fiscal year, less
an amount equal to the sum of all base
amounts determined for the States under
subparagraph (B), and less the amount, if
any, reserved by the Secretary under paragraphs (4) and (5); and
(ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an
amount equal to the population of the
State over an amount equal to the total
population of the States (as indicated by
the most recent data collected by the Bureau of the Census).
(D) Minimum amount
Subject to the amount appropriated under
paragraph (1)(A)(i)(I),5 an award pursuant to
subparagraph (A) for a State shall be the
greater of the base amount as increased
under subparagraph (C), or the minimum
amount under this subparagraph. The minimum amount under this subparagraph is—
(i) in the case of each of the several
States, the District of Columbia, and the
Commonwealth of Puerto Rico, an amount
equal to the lesser of—
(I) $5,000,000; or
(II) if the amount appropriated under
paragraph (1)(A)(i)(I) 5 is less than
$667,000,000, an amount equal to 0.75 percent of the amount appropriated under
such paragraph, less the amount, if any,
reserved by the Secretary under paragraphs (4) and (5); or
(ii) in the case of each of American
Samoa, Guam, the Commonwealth of the
Northern Mariana Islands, and the Virgin
Islands, an amount determined by the Secretary to be appropriate, except that such
amount may not exceed the amount determined under clause (i).
(4) Certain political subdivisions
(A) In general
For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph
(3) for such year, reserve from the amount
appropriated under paragraph (1) for the
year an amount determined necessary by the
Secretary to make awards under subsection
(a) of this section to political subdivisions
that have a substantial number of residents,
have a substantial local infrastructure for
responding to public health emergencies,
and face a high degree of risk from bioterrorist attacks or other public health
5 See

References in Text note below.

Page 199

TITLE 42—THE PUBLIC HEALTH AND WELFARE

emergencies. Not more than three political
subdivisions may receive awards pursuant to
this subparagraph.
(B) Coordination with Statewide plans
An award pursuant to subparagraph (A)
may not be made unless the application of
the political subdivision involved is in coordination with, and consistent with, applicable Statewide plans described in subsection (c) of this section.
(C) Relationship to formula grants
In the case of a State that will receive an
award pursuant to paragraph (3), and in
which there is located a political subdivision
that will receive an award pursuant to subparagraph (A), the Secretary shall, in determining the amount under paragraph (3)(C)
for the State, subtract from the population
of the State an amount equal to the population of such political subdivision.
(D) Continuity of funding
In determining whether to make an award
pursuant to subparagraph (A) to a political
subdivision, the Secretary may consider, as
a factor indicating that the award should be
made, that the political subdivision received
public health funding from the Secretary for
fiscal year 2006.
(5) Significant unmet needs; degree of risk
(A) In general
For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph
(3) for such year, reserve from the amount
appropriated under paragraph (1) for the
year an amount determined necessary by the
Secretary to make awards under subsection
(a) of this section to eligible entities that—
(i) have a significant need for funds to
build capacity to identify, detect, monitor,
and respond to a bioterrorist or other
threat to the public health, which need
will not be met by awards pursuant to
paragraph (3); and
(ii) face a particularly high degree of
risk of such a threat.
(B) Recipients of grants
Awards pursuant to subparagraph (A) may
be supplemental awards to States that receive awards pursuant to paragraph (3), or
may be awards to eligible entities described
in subsection (b)(1)(B) of this section within
such States.
(C) Finding with respect to District of Columbia
The Secretary shall consider the District
of Columbia to have a significant unmet
need for purposes of subparagraph (A), and
to face a particularly high degree of risk for
such purposes, on the basis of the concentration of entities of national significance located within the District.
(6) Funding of local entities
The Secretary shall, in making awards under
this section, ensure that with respect to the
cooperative agreement awarded, the entity
make available appropriate portions of such

§ 247d–3a

award to political subdivisions and local departments of public health through a process
involving the consensus, approval or concurrence with such local entities.
(j) Administrative and fiscal responsibility
(1) Annual reporting requirements
Each entity shall prepare and submit to the
Secretary annual reports on its activities
under this section and section 247d–3b of this
title. Each such report shall be prepared by, or
in consultation with, the health department.
In order to properly evaluate and compare the
performance of different entities assisted
under this section and section 247d–3b of this
title and to assure the proper expenditure of
funds under this section and section 247d–3b of
this title, such reports shall be in such standardized form and contain such information as
the Secretary determines and describes within
180 days of December 19, 2006 (after consultation with the States) to be necessary to—
(A) secure an accurate description of those
activities;
(B) secure a complete record of the purposes for which funds were spent, and of the
recipients of such funds;
(C) describe the extent to which the entity
has met the goals and objectives it set forth
under this section or section 247d–3b of this
title;
(D) determine the extent to which funds
were expended consistent with the entity’s
application transmitted under this section
or section 247d–3b of this title; and
(E) publish such information on a Federal
Internet website consistent with subsection
(k).
(2) Audits; implementation
(A) In general
Each entity receiving funds under this section or section 247d–3b of this title shall, not
less often than once every 2 years, audit its
expenditures from amounts received under
this section or section 247d–3b of this title.
Such audits shall be conducted by an entity
independent of the agency administering a
program funded under this section or section
247d–3b of this title in accordance with the
Comptroller General’s standards for auditing
governmental organizations, programs, activities, and functions and generally accepted auditing standards. Within 30 days following the completion of each audit report, the
entity shall submit a copy of that audit report to the Secretary.
(B) Repayment
Each entity shall repay to the United
States amounts found by the Secretary,
after notice and opportunity for a hearing to
the entity, not to have been expended in accordance with this section or section 247d–3b
of this title and, if such repayment is not
made, the Secretary may offset such
amounts against the amount of any allotment to which the entity is or may become
entitled under this section or section 247d–3b
of this title or may otherwise recover such
amounts.

§ 247d–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) Withholding of payment
The Secretary may, after notice and opportunity for a hearing, withhold payment
of funds to any entity which is not using its
allotment under this section or section
247d–3b of this title in accordance with such
section. The Secretary may withhold such
funds until the Secretary finds that the reason for the withholding has been removed
and there is reasonable assurance that it
will not recur.
(3) Maximum carryover amount
(A) In general
For each fiscal year, the Secretary, in consultation with the States and political subdivisions, shall determine the maximum percentage amount of an award under this section that an entity may carryover to the
succeeding fiscal year.
(B) Amount exceeded
For each fiscal year, if the percentage
amount of an award under this section unexpended by an entity exceeds the maximum
percentage permitted by the Secretary
under subparagraph (A), the entity shall return to the Secretary the portion of the unexpended amount that exceeds the maximum
amount permitted to be carried over by the
Secretary.
(C) Action by Secretary
The Secretary shall make amounts returned to the Secretary under subparagraph
(B) available for awards under section
247d–3b(b)(1) of this title. In making awards
under section 247d–3b(b)(1) of this title with
amounts collected under this paragraph the
Secretary shall give preference to entities
that are located in whole or in part in States
from which amounts have been returned
under subparagraph (B).
(D) Waiver
An entity may apply to the Secretary for
a waiver of the maximum percentage
amount under subparagraph (A). Such an application for a waiver shall include an explanation why such requirement should not
apply to the entity and the steps taken by
such entity to ensure that all funds under an
award under this section will be expended
appropriately.
(E) Waive or reduce withholding
The Secretary may waive the application
of subparagraph (B), or reduce the amount
determined under such subparagraph, for a
single entity pursuant to subparagraph (D)
or for all entities in a fiscal year, if the Secretary determines that mitigating conditions exist that justify the waiver or reduction.
(k) Compilation and availability of data
The Secretary shall compile the data submitted under this section and make such data available in a timely manner on an appropriate Internet website in a format that is useful to the public and to other entities and that provides information on what activities are best contributing

Page 200

to the achievement of the outcome goals described in subsection (g).
(July 1, 1944, ch. 373, title III, § 319C–1, as added
Pub. L. 107–188, title I, § 131(a), June 12, 2002, 116
Stat. 617; amended Pub. L. 109–417, title II, § 201,
Dec. 19, 2006, 120 Stat. 2837.)
REFERENCES IN TEXT
Paragraph (1)(A) of subsec. (i), referred to in subsec.
(i)(3)(C), (D), was struck out and a new paragraph (1)(A)
added by Pub. L. 109–417, title II, § 201(4)(A), Dec. 19,
2006, 120 Stat. 2837. The new paragraph (1)(A) does not
contain a clause (i).
CODIFICATION
December 19, 2006, referred to in subsec. (g)(2)(B), was
in the original ‘‘the date of enactment of this section’’,
which was translated as meaning the date of enactment
of Pub. L. 109–417, which enacted subsec. (g) of this section, to reflect the probable intent of Congress.
AMENDMENTS
2006—Pub. L. 109–417, § 201(1), substituted ‘‘Improving
State and local public health security’’ for ‘‘Grants to
improve State, local, and hospital preparedness for and
response to bioterrorism and other public health emergencies’’ in section catchline.
Subsecs. (a) to (h). Pub. L. 109–417, § 201(2), added subsecs. (a) to (h) and struck out former subsecs. (a) to (h)
which related to grants to improve State, local, and
hospital preparedness for and response to bioterrorism
and other public health emergencies.
Subsec. (i). Pub. L. 109–417, § 201(3), redesignated subsec. (j) as (i).
Pub. L. 109–417, § 201(2), struck out subsec. (i) which
defined ‘‘eligible entity’’.
Subsec. (i)(1) to (3)(A). Pub. L. 109–417, § 201(4)(A),
added pars. (1) to (3)(A) and struck out former pars. (1)
to (3)(A) which related to appropriations for fiscal
years 2003 through 2006, use of amounts to supplement
and not supplant other funds, and conditions for receipt
of award in fiscal year 2003.
Subsec. (i)(4)(A). Pub. L. 109–417, § 201(4)(B), substituted ‘‘fiscal year 2007’’ for ‘‘fiscal year 2003’’ and
struck out ‘‘(A)(i)(I)’’ after ‘‘paragraph (1)’’.
Subsec. (i)(4)(D). Pub. L. 109–417, § 201(4)(C), substituted ‘‘fiscal year 2006’’ for ‘‘fiscal year 2002’’.
Subsec. (i)(5)(A). Pub. L. 109–417, § 201(4)(D), in introductory provisions, substituted ‘‘fiscal year 2007’’ for
‘‘fiscal year 2003’’ and struck out ‘‘(A)(i)(I)’’ after
‘‘paragraph (1)’’.
Subsec. (i)(6). Pub. L. 109–417, § 201(4)(E), added par. (6)
and struck out heading and text of former par. (6). Text
read as follows: ‘‘For fiscal year 2003, the Secretary
shall in making awards under this section ensure that
appropriate portions of such awards are made available
to political subdivisions, local departments of public
health, hospitals (including children’s hospitals), clinics, health centers, or primary care facilities, or consortia of such entities.’’
Subsec. (j). Pub. L. 109–417, § 201(5), added subsec. (j).
Pub. L. 109–417, § 201(3), redesignated subsec. (j) as (i).
Subsec. (k). Pub. L. 109–417, § 201(5), added subsec. (k).
EMERGENCY MEDICAL AND PUBLIC HEALTH
COMMUNICATIONS PILOT PROJECTS
Pub. L. 110–53, title XXII, § 2201(d), Aug. 3, 2007, 121
Stat. 541, provided that:
‘‘(1) IN GENERAL.—The Assistant Secretary of Commerce for Communications and Information may establish not more than 10 geographically dispersed project
grants to emergency medical and public health care facilities to improve the capabilities of emergency communications systems in emergency medical care facilities.
‘‘(2) MAXIMUM AMOUNT.—The Assistant Secretary may
not provide more than $2,000,000 in Federal assistance
under the pilot program to any applicant.

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‘‘(3) COST SHARING.—The Assistant Secretary may not
provide more than 20 percent of the cost, incurred during the period of the grant, of any project under the
pilot program.
‘‘(4) MAXIMUM PERIOD OF GRANTS.—The Assistant Secretary may not fund any applicant under the pilot program for more than 3 years.
‘‘(5) DEPLOYMENT AND DISTRIBUTION.—The Assistant
Secretary shall seek to the maximum extent practicable to ensure a broad geographic distribution of
project sites.
‘‘(6) TRANSFER OF INFORMATION AND KNOWLEDGE.—The
Assistant Secretary shall establish mechanisms to ensure that the information and knowledge gained by
participants in the pilot program are transferred
among the pilot program participants and to other interested parties, including other applicants that submitted applications.’’

§ 247d–3b. Partnerships for State and regional
hospital preparedness to improve surge capacity
(a) In general
The Secretary shall award competitive grants
or cooperative agreements to eligible entities to
enable such entities to improve surge capacity
and enhance community and hospital preparedness for public health emergencies.
(b) Eligibility
To be eligible for an award under subsection
(a), an entity shall—
(1)(A) be a partnership consisting of—
(i) one or more hospitals, at least one of
which shall be a designated trauma center,
consistent with section 300d–13(c) of this
title;
(ii) one or more other local health care facilities, including clinics, health centers,
primary care facilities, mental health centers, mobile medical assets, or nursing
homes; and
(iii)(I) one or more political subdivisions;
(II) one or more States; or
(III) one or more States and one or more
political subdivisions; and
(B) prepare, in consultation with the Chief
Executive Officer and the lead health officials
of the State, District, or territory in which
the hospital and health care facilities described in subparagraph (A) are located, and
submit to the Secretary, an application at
such time, in such manner, and containing
such information as the Secretary may require; or
(2)(A) be an entity described in section
247d–3a(b)(1) of this title; and
(B) submit an application at such time, in
such manner, and containing such information
as the Secretary may require, including the
information or assurances required under section 247d–3a(b)(2) of this title and an assurance
that the State will adhere to any applicable
guidelines established by the Secretary.
(c) Use of funds
An award under subsection (a) shall be expended for activities to achieve the preparedness
goals described under paragraphs (1), (3), (4), (5),
and (6) of section 300hh–1(b) of this title.
(d) Preferences
(1) Regional coordination
In making awards under subsection (a), the
Secretary shall give preference to eligible en-

§ 247d–3b

tities that submit applications that, in the determination of the Secretary—
(A) will enhance coordination—
(i) among the entities described in subsection (b)(1)(A)(i); and
(ii) between such entities and the entities described in subsection (b)(1)(A)(ii);
and
(B) include, in the partnership described in
subsection (b)(1)(A), a significant percentage
of the hospitals and health care facilities
within the geographic area served by such
partnership.
(2) Other preferences
In making awards under subsection (a), the
Secretary shall give preference to eligible entities that, in the determination of the Secretary—
(A) include one or more hospitals that are
participants in the National Disaster Medical System;
(B) are located in a geographic area that
faces a high degree of risk, as determined by
the Secretary in consultation with the Secretary of Homeland Security; or
(C) have a significant need for funds to
achieve the medical preparedness goals described in section 300hh–1(b)(3) of this title.
(e) Consistency of planned activities
The Secretary may not award a cooperative
agreement to an eligible entity described in subsection (b)(1) unless the application submitted
by the entity is coordinated and consistent with
an applicable State All-Hazards Public Health
Emergency Preparedness and Response Plan and
relevant local plans, as determined by the Secretary in consultation with relevant State
health officials.
(f) Limitation on awards
A political subdivision shall not participate in
more than one partnership described in subsection (b)(1).
(g) Coordination with local response capabilities
An eligible entity shall, to the extent practicable, ensure that activities carried out under
an award under subsection (a) are coordinated
with activities of relevant local Metropolitan
Medical Response Systems, local Medical Reserve Corps, the Cities Readiness Initiative, and
local emergency plans.
(h) Maintenance of funding
(1) In general
An entity that receives an award under this
section shall maintain expenditures for health
care preparedness at a level that is not less
than the average level of such expenditures
maintained by the entity for the preceding 2
year period.
(2) Rule of construction
Nothing in this section shall be construed to
prohibit the use of awards under this section
to pay salary and related expenses of public
health and other professionals employed by
State, local, or tribal agencies who are carrying out activities supported by such awards
(regardless of whether the primary assignment

§ 247d–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of such personnel is to carry out such activities).
(i) Performance and accountability
The requirements of section 247d–3a(g), (j), and
(k) of this title shall apply to entities receiving
awards under this section (regardless of whether
such entities are described under subsection
(b)(1)(A) or (b)(2)(A)) in the same manner as such
requirements apply to entities under section
247d–3a of this title. An entity described in subsection (b)(1)(A) shall make such reports available to the lead health official of the State in
which such partnership is located.
(j) Authorization of appropriations
(1) In general
For the purpose of carrying out this section,
there is authorized to be appropriated
$474,000,000 for fiscal year 2007, and such sums
as may be necessary for each of fiscal years
2008 through 2011.
(2) Reservation of amounts for partnerships
Prior to making awards described in paragraph (3), the Secretary may reserve from the
amount appropriated under paragraph (1) for a
fiscal year, an amount determined appropriate
by the Secretary for making awards to entities described in subsection (b)(1)(A).
(3) Awards to States and political subdivisions
(A) In general
From amounts appropriated for a fiscal
year under paragraph (1) and not reserved
under paragraph (2), the Secretary shall
make awards to entities described in subsection (b)(2)(A) that have completed an application as described in subsection (b)(2)(B).
(B) Amount
The Secretary shall determine the amount
of an award to each entity described in subparagraph (A) in the same manner as such
amounts are determined under section
247d–3a(i) of this title.
(July 1, 1944, ch. 373, title III, § 319C–2, as added
Pub. L. 107–188, title I, § 131(a), June 12, 2002, 116
Stat. 624; amended Pub. L. 109–417, title III, § 305,
Dec. 19, 2006, 120 Stat. 2861; Pub. L. 110–85, title
XI, § 1104(1), Sept. 27, 2007, 121 Stat. 975.)
AMENDMENTS
2007—Subsec. (j)(3)(B). Pub. L. 110–85 substituted ‘‘section 247d–3a(i)’’ for ‘‘section 247d–3a(h)’’.
2006—Pub. L. 109–417 amended section catchline and
text generally. Prior to amendment, section consisted
of subsecs. (a) to (i) relating to partnerships for community and hospital preparedness.

§ 247d–4. Revitalizing the Centers for Disease
Control and Prevention
(a) Facilities; capacities
(1) Findings
Congress finds that the Centers for Disease
Control and Prevention has an essential role
in defending against and combatting public
health threats domestically and abroad and
requires secure and modern facilities, and expanded and improved capabilities related to
bioterrorism and other public health emer-

Page 202

gencies, sufficient to enable such Centers to
conduct this important mission.
(2) Facilities
(A) In general
The Director of the Centers for Disease
Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities
and infrastructure), and upgrade security of
such facilities, in order to better conduct
the capacities described in section 247d–1 of
this title, and for supporting public health
activities.
(B) Multiyear contracting authority
For any project of designing, constructing,
equipping, or renovating any facility under
subparagraph (A), the Director of the Centers for Disease Control and Prevention may
enter into a single contract or related contracts that collectively include the full
scope of the project, and the solicitation and
contract shall contain the clause ‘‘availability of funds’’ found at section 52.232–18 of
title 48, Code of Federal Regulations.
(3) Improving the capacities of the Centers for
Disease Control and Prevention
The Secretary shall expand, enhance, and
improve the capabilities of the Centers for
Disease Control and Prevention relating to
preparedness for and responding effectively to
bioterrorism and other public health emergencies. Activities that may be carried out
under the preceding sentence include—
(A) expanding or enhancing the training of
personnel;
(B) improving communications facilities
and networks, including delivery of necessary information to rural areas;
(C) improving capabilities for public
health surveillance and reporting activities,
taking into account the integrated system
or systems of public health alert communications and surveillance networks under
subsection (b) of this section; and
(D) improving laboratory facilities related
to bioterrorism and other public health
emergencies, including increasing the security of such facilities.
(b) National communications and surveillance
networks
(1) In general
The Secretary, directly or through awards of
grants, contracts, or cooperative agreements,
shall provide for the establishment of an integrated system or systems of public health
alert communications and surveillance networks between and among—
(A) Federal, State, and local public health
officials;
(B) public and private health-related laboratories, hospitals, and other health care
facilities; and
(C) any other entities determined appropriate by the Secretary.

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(2) Requirements
The Secretary shall ensure that networks
under paragraph (1) allow for the timely sharing and discussion, in a secure manner, of essential information concerning bioterrorism
or another public health emergency, or recommended methods for responding to such an
attack or emergency.
(3) Standards
Not later than one year after June 12, 2002,
the Secretary, in cooperation with health care
providers and State and local public health officials, shall establish any additional technical
and reporting standards (including standards
for interoperability) for networks under paragraph (1).
(c) Authorization of appropriations
(1) Facilities; capacities
(A) Facilities
For the purpose of carrying out subsection
(a)(2) of this section, there are authorized to
be appropriated $300,000,000 for each of the
fiscal years 2002 and 2003, and such sums as
may be necessary for each of the fiscal years
2004 through 2006.
(B) Mission; improving capacities
For the purposes of achieving the mission
of the Centers for Disease Control and Prevention described in subsection (a)(1) of this
section, for carrying out subsection (a)(3) of
this section, for better conducting the capacities described in section 247d–1 of this
title, and for supporting public health activities, there are authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.
(2) National communications and surveillance
networks
For the purpose of carrying out subsection
(b) of this section, there are authorized to be
appropriated such sums as may be necessary
for each of the fiscal years 2002 through 2006.
(d) Public health situational awareness
(1) In general
Not later than 2 years after December 19,
2006, the Secretary, in collaboration with
State, local, and tribal public health officials,
shall establish a near real-time electronic nationwide public health situational awareness
capability through an interoperable network
of systems to share data and information to
enhance early detection of rapid response to,
and management of, potentially catastrophic
infectious disease outbreaks and other public
health emergencies that originate domestically or abroad. Such network shall be built
on existing State situational awareness systems or enhanced systems that enable such
connectivity.
(2) Strategic plan
Not later than 180 days after December 19,
2006, the Secretary shall submit to the appropriate committees of Congress, a strategic
plan that demonstrates the steps the Secretary will undertake to develop, implement,
and evaluate the network described in para-

§ 247d–4

graph (1), utilizing the elements described in
paragraph (3).
(3) Elements
The network described in paragraph (1) shall
include data and information transmitted in a
standardized format from—
(A) State, local, and tribal public health
entities, including public health laboratories;
(B) Federal health agencies;
(C) zoonotic disease monitoring systems;
(D) public and private sector health care
entities, hospitals, pharmacies, poison control centers or professional organizations in
the field of poison control, and clinical laboratories, to the extent practicable and provided that such data are voluntarily provided simultaneously to the Secretary and
appropriate State, local, and tribal public
health agencies; and
(E) such other sources as the Secretary
may deem appropriate.
(4) Rule of construction
Paragraph (3) shall not be construed as requiring separate reporting of data and information from each source listed.
(5) Required activities
In establishing and operating the network
described in paragraph (1), the Secretary
shall—
(A) utilize applicable interoperability
standards as determined by the Secretary
through a joint public and private sector
process;
(B) define minimal data elements for such
network;
(C) in collaboration with State, local, and
tribal public health officials, integrate and
build upon existing State, local, and tribal
capabilities, ensuring simultaneous sharing
of data, information, and analyses from the
network described in paragraph (1) with
State, local, and tribal public health agencies; and
(D) in collaboration with State, local, and
tribal public health officials, develop procedures and standards for the collection,
analysis, and interpretation of data that
States, regions, or other entities collect and
report to the network described in paragraph
(1).
(e) State and regional systems to enhance situational awareness in public health emergencies
(1) In general
To implement the network described in subsection (d), the Secretary may award grants to
States or consortia of States to enhance the
ability of such States or consortia of States to
establish or operate a coordinated public
health situational awareness system for regional or Statewide early detection of, rapid
response to, and management of potentially
catastrophic infectious disease outbreaks and
public health emergencies, in collaboration
with appropriate public health agencies, sentinel hospitals, clinical laboratories, pharmacies, poison control centers, other health

§ 247d–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

care organizations, and animal health organizations within such States.
(2) Eligibility
To be eligible to receive a grant under paragraph (1), the State or consortium of States
shall submit to the Secretary an application
at such time, in such manner, and containing
such information as the Secretary may require, including an assurance that the State or
consortium of States will submit to the Secretary—
(A) reports of such data, information, and
metrics as the Secretary may require;
(B) a report on the effectiveness of the systems funded under the grant; and
(C) a description of the manner in which
grant funds will be used to enhance the
timelines and comprehensiveness of efforts
to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public health emergencies.
(3) Use of funds
A State or consortium of States that receives an award under this subsection—
(A) shall establish, enhance, or operate a
coordinated public health situational awareness system for regional or Statewide early
detection of, rapid response to, and management of potentially catastrophic infectious
disease outbreaks and public health emergencies;
(B) may award grants or contracts to entities described in paragraph (1) within or
serving such State to assist such entities in
improving the operation of information
technology systems, facilitating the secure
exchange of data and information, and training personnel to enhance the operation of
the system described in subparagraph (A);
and
(C) may conduct a pilot program for the
development of multi-State telehealth network test beds that build on, enhance, and
securely link existing State and local telehealth programs to prepare for, monitor, respond to, and manage the events of public
health emergencies, facilitate coordination
and communication among medical, public
health, and emergency response agencies,
and provide medical services through telehealth initiatives within the States that are
involved in such a multi-State telehealth
network test bed.
(4) Limitation
Information technology systems acquired or
implemented using grants awarded under this
section must be compliant with—
(A) interoperability and other technological standards, as determined by the Secretary; and
(B) data collection and reporting requirements for the network described in subsection (d).
(5) Independent evaluation
Not later than 4 years after December 19,
2006, the Government Accountability Office
shall conduct an independent evaluation, and
submit to the Secretary and the appropriate

Page 204

committees of Congress a report concerning
the activities conducted under this subsection
and subsection (d).
(f) Telehealth enhancements for emergency response
(1) Evaluation
The Secretary, in consultation with the Federal Communications Commission and other
relevant Federal agencies, shall—
(A) conduct an inventory of telehealth initiatives in existence on December 19, 2006,
including—
(i) the specific location of network components;
(ii) the medical, technological, and communications capabilities of such components;
(iii) the functionality of such components; and
(iv) the capacity and ability of such components to handle increased volume during
the response to a public health emergency;
(B) identify methods to expand and interconnect the regional health information networks funded by the Secretary, the State
and regional broadband networks funded
through the rural health care support mechanism pilot program funded by the Federal
Communications Commission, and other
telehealth networks;
(C) evaluate ways to prepare for, monitor,
respond rapidly to, or manage the events of,
a public health emergency through the enhanced use of telehealth technologies, including mechanisms for payment or reimbursement for use of such technologies and
personnel during public health emergencies;
(D) identify methods for reducing legal
barriers that deter health care professionals
from providing telemedicine services, such
as by utilizing State emergency health care
professional credentialing verification systems, encouraging States to establish and
implement mechanisms to improve interstate medical licensure cooperation, facilitating the exchange of information among
States regarding investigations and adverse
actions, and encouraging States to waive the
application of licensing requirements during
a public health emergency;
(E) evaluate ways to integrate the practice
of telemedicine within the National Disaster
Medical System; and
(F) promote greater coordination among
existing Federal interagency telemedicine
and health information technology initiatives.
(2) Report
Not later than 12 months after December 19,
2006, the Secretary shall prepare and submit a
report to the Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of
the House of Representatives regarding the
findings and recommendations pursuant to
subparagraphs (A) through (F) of paragraph
(1).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, such sums as may be necessary in each of fiscal years 2007 through 2011.
(July 1, 1944, ch. 373, title III, § 319D, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2318; amended Pub. L. 107–188, title I, § 103,
June 12, 2002, 116 Stat. 603; Pub. L. 109–417, title
II, §§ 202, 204(b)(2), Dec. 19, 2006, 120 Stat. 2845,
2851.)
AMENDMENTS
2006—Subsec. (a)(1). Pub. L. 109–417, § 202(1), inserted
‘‘domestically and abroad’’ after ‘‘public health
threats’’.
Subsec. (a)(3). Pub. L. 109–417, § 204(b)(2), struck out
‘‘, taking into account evaluations under section
247d–2(a) of this title,’’ after ‘‘The Secretary’’ in introductory provisions.
Subsecs. (d) to (g). Pub. L. 109–417, § 202(2), added subsecs. (d) to (g).
2002—Pub. L. 107–188 reenacted section catchline
without change and amended text generally, substituting detailed provisions relating to facilities, capacities,
and national communications and surveillance networks for provisions relating to findings of need for secure and modern facilities.

§ 247d–5. Combating antimicrobial resistance
(a) Task force
(1) In general
The Secretary shall establish an Antimicrobial Resistance Task Force to provide
advice and recommendations to the Secretary
and coordinate Federal programs relating to
antimicrobial resistance. The Secretary may
appoint or select a committee, or other organization in existence as of November 13, 2000,
to serve as such a task force, if such committee, or other organization meets the requirements of this section.
(2) Members of task force
The task force described in paragraph (1)
shall be composed of representatives from
such Federal agencies, and shall seek input
from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
(3) Agenda
(A) In general
The task force described in paragraph (1)
shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to
increasing antimicrobial resistance;
(ii) public health needs to detect and
monitor antimicrobial resistance;
(iii) detection, prevention, and control
strategies for resistant pathogens;
(iv) the need for improved information
and data collection;
(v) the assessment of the risk imposed by
pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary
determines are relevant to antimicrobial
resistance.

§ 247d–5

(B) Detection and control
The Secretary, in consultation with the
task force described in paragraph (1) and
State and local public health officials,
shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan
to detect and monitor emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and
exchange antimicrobial resistance data between public health departments.
(4) Meetings
The task force described under paragraph (1)
shall convene not less than twice a year, or
more frequently as the Secretary determines
to be appropriate.
(b) Research and development of new antimicrobial drugs and diagnostics
The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established
under subsection (a) of this section, shall directly or through awards of grants or cooperative agreements to public or private entities
provide for the conduct of research, investigations, experiments, demonstrations, and studies
in the health sciences that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against
resistant pathogens;
(2) the development or testing of medical
diagnostics to detect pathogens resistant to
antimicrobials;
(3) the epidemiology, mechanisms, and
pathogenesis of antimicrobial resistance;
(4) the sequencing of the genomes, or other
DNA analysis, or other comparative analysis,
of priority pathogens (as determined by the
Director of the National Institutes of Health
in consultation with the task force established
under subsection (a) of this section), in collaboration and coordination with the activities of the Department of Defense and the
Joint Genome Institute of the Department of
Energy; and
(5) other relevant research areas.
(c) Education of medical and public health personnel
The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease
Control and Prevention, the Administrator of
the Health Resources and Services Administration, the Director of the Agency for Healthcare
Research and Quality, members of the task force
described in subsection (a) of this section, professional organizations and societies, and such
other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general
public with respect to the public health threat
of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in
the prudent use of antibiotics; and

§ 247d–5a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) develop and implement programs to train
laboratory personnel in the recognition or
identification of resistance in pathogens.
(d) Grants
(1) In general
The Secretary shall award competitive
grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.
(2) Eligible entities
Eligible entities for grants under paragraph
(1) shall be State or local public health agencies, Indian tribes or tribal organizations, or
other public or private nonprofit entities.
(3) Use of funds
An eligible entity receiving a grant under
paragraph (1) shall use funds from such grant
for activities that are consistent with the factors identified by the task force under subsection (a)(3) of this section, which may include activities that—
(A) provide training to enable such entity
to identify patterns of resistance rapidly and
accurately;
(B) develop, improve, coordinate or enhance participation in information systems
by which data on resistant infections can be
shared rapidly among relevant national,
State, and local health agencies and health
care providers; and
(C) develop and implement policies to control the spread of antimicrobial resistance.
(e) Grants for demonstration programs
(1) In general
The Secretary shall award competitive
grants to eligible entities to establish demonstration programs to promote judicious use
of antimicrobial drugs or control the spread of
antimicrobial-resistant pathogens.
(2) Eligible entities
Eligible entities for grants under paragraph
(1) may include hospitals, clinics, institutions
of long-term care, professional medical societies, schools or programs that train medical
laboratory personnel, or other public or private nonprofit entities.
(3) Technical assistance
The Secretary shall provide appropriate
technical assistance to eligible entities that
receive grants under paragraph (1).
(f) Supplement not supplant
Funds appropriated under this section shall be
used to supplement and not supplant other Federal, State, and local public funds provided for
activities under this section.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $40,000,000 for fiscal year
2001, $25,000,000 for each of the fiscal years 2002
and 2003, and such sums as may be necessary for
each of the fiscal years 2004 through 2006.
(July 1, 1944, ch. 373, title III, § 319E, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2318; amended Pub. L. 107–188, title I, § 109,
June 12, 2002, 116 Stat. 610.)

Page 206

AMENDMENTS
2002—Subsec. (b). Pub. L. 107–188, § 109(1)(A), in introductory provisions, substituted ‘‘shall directly or
through awards of grants or cooperative agreements to
public or private entities provide for the conduct of’’
for ‘‘shall conduct and support’’.
Subsec. (b)(4). Pub. L. 107–188, § 109(1)(B), amended
par. (4) generally. Prior to amendment, par. (4) read as
follows: ‘‘the sequencing of the genomes of priority
pathogens as determined by the Director of the National Institutes of Health in consultation with the
task force established under subsection (a) of this section; and’’.
Subsec. (e)(2). Pub. L. 107–188, § 109(2), inserted
‘‘schools or programs that train medical laboratory
personnel,’’ after ‘‘professional medical societies,’’.
Subsec. (g). Pub. L. 107–188, § 109(3), substituted
‘‘$25,000,000 for each of the fiscal years 2002 and 2003,
and such sums as may be necessary for each of the fiscal years 2004 through 2006’’ for ‘‘and such sums as may
be necessary for each subsequent fiscal year through
2006’’.

§ 247d–5a. Identification of clinically susceptible
concentrations of antimicrobials
(a) Definition
In this section, the term ‘‘clinically susceptible concentrations’’ means specific values
which characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or
drugs) tested.
(b) Identification
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’),
through the Commissioner of Food and Drugs,
shall identify (where such information is reasonably available) and periodically update clinically susceptible concentrations.
(c) Public availability
The Secretary, through the Commissioner of
Food and Drugs, shall make such clinically susceptible concentrations publicly available, such
as by posting on the Internet, not later than 30
days after the date of identification and any update under this section.
(d) Effect
Nothing in this section shall be construed to
restrict, in any manner, the prescribing of antibiotics by physicians, or to limit the practice of
medicine, including for diseases such as Lyme
and tick-borne diseases.
(Pub. L. 110–85, title XI, § 1111, Sept. 27, 2007, 121
Stat. 975.)
CODIFICATION
Section was enacted as part of the Food and Drug Administration Amendments Act of 2007, and not as part
of the Public Health Service Act which comprises this
chapter.

§ 247d–6. Public health countermeasures to a bioterrorist attack
(a) All-hazards public health and medical response curricula and training
(1) In general
The Secretary, in collaboration with the
Secretary of Defense, and in consultation with
relevant public and private entities, shall develop core health and medical response curric-

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ula and trainings by adapting applicable existing curricula and training programs to improve responses to public health emergencies.
(2) Curriculum
The public health and medical response
training program may include course work related to—
(A) medical management of casualties,
taking into account the needs of at-risk individuals;
(B) public health aspects of public health
emergencies;
(C) mental health aspects of public health
emergencies;
(D) national incident management, including coordination among Federal, State,
local, tribal, international agencies, and
other entities; and
(E) protecting health care workers and
health care first responders from workplace
exposures during a public health emergency.
(3) Peer review
On a periodic basis, products prepared as
part of the program shall be rigorously tested
and peer-reviewed by experts in the relevant
fields.
(4) Credit
The Secretary and the Secretary of Defense
shall—
(A) take into account continuing professional education requirements of public
health and healthcare professions; and
(B) cooperate with State, local, and tribal
accrediting agencies and with professional
associations in arranging for students enrolled in the program to obtain continuing
professional education credit for program
courses.
(5) Dissemination and training
(A) In general
The Secretary may provide for the dissemination and teaching of the materials described in paragraphs (1) and (2) by appropriate means, as determined by the Secretary.
(B) Certain entities
The education and training activities described in subparagraph (A) may be carried
out by Federal public health or medical entities, appropriate educational entities, professional organizations and societies, private
accrediting organizations, and other nonprofit institutions or entities meeting criteria established by the Secretary.
(C) Grants and contracts
In carrying out this subsection, the Secretary may carry out activities directly or
through the award of grants and contracts,
and may enter into interagency agreements
with other Federal agencies.
(b) Advice to the Federal Government
(1) Required advisory committees
In coordination with the working group
under subsection (a) of this section, the Secretary shall establish advisory committees in
accordance with paragraphs (2) and (3) to pro-

§ 247d–6

vide expert recommendations to assist such
working groups in carrying out their respective responsibilities under subsections (a) and
(b) of this section.
(2) National Advisory Committee on At-Risk Individuals and Public Health Emergencies
(A) In general
For purposes of paragraph (1), the Secretary shall establish an advisory committee
to be known as the National Advisory Committee on At-Risk Individuals and Public
Health Emergencies (referred to in this paragraph as the ‘‘Advisory Committee’’).
(B) Duties
The Advisory Committee shall provide recommendations regarding—
(i) the preparedness of the health care
(including mental health care) system to
respond to public health emergencies as
they relate to at-risk individuals;
(ii) needed changes to the health care
and emergency medical service systems
and emergency medical services protocols
to meet the special needs of at-risk individuals; and
(iii) changes, if necessary, to the national stockpile under section 300hh–12 of
this title to meet the emergency health security of at-risk individuals.
(C) Composition
The Advisory Committee shall be composed of such Federal officials as may be appropriate to address the special needs of the
diverse population groups of at-risk populations.
(D) Termination
The Advisory Committee terminates six
years after June 12, 2002.
(3) Emergency Public Information and Communications Advisory Committee
(A) In general
For purposes of paragraph (1), the Secretary shall establish an advisory committee
to be known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the
‘‘EPIC Advisory Committee’’).
(B) Duties
The EPIC Advisory Committee shall make
recommendations to the Secretary and report on appropriate ways to communicate
public health information regarding bioterrorism and other public health emergencies to the public.
(C) Composition
The EPIC Advisory Committee shall be
composed of individuals representing a diverse group of experts in public health, medicine, communications, behavioral psychology, and other areas determined appropriate
by the Secretary.
(D) Dissemination
The Secretary shall review the recommendations of the EPIC Advisory Committee and ensure that appropriate information
is disseminated to the public.

§ 247d–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(E) Termination
The EPIC Advisory Committee terminates
one year after June 12, 2002.
(c) Expansion of Epidemic Intelligence Service
Program
The Secretary may establish 20 officer positions in the Epidemic Intelligence Service Program, in addition to the number of the officer
positions offered under such Program in 2006, for
individuals who agree to participate, for a period of not less than 2 years, in the Career Epidemiology Field Officer program in a State,
local, or tribal health department that serves a
health professional shortage area (as defined
under section 254e(a) of this title), a medically
underserved population (as defined under section
254b(b)(3) of this title), or a medically underserved area or area at high risk of a public
health emergency as designated by the Secretary.
(d) Centers for Public Health Preparedness; core
curricula and training
(1) In general
The Secretary may establish at accredited
schools of public health, Centers for Public
Health Preparedness (hereafter referred to in
this section as the ‘‘Centers’’).
(2) Eligibility
To be eligible to receive an award under this
subsection to establish a Center, an accredited
school of public health shall agree to conduct
activities consistent with the requirements of
this subsection.
(3) Core curricula
The Secretary, in collaboration with the
Centers and other public or private entities
shall establish core curricula based on established competencies leading to a 4-year bachelor’s degree, a graduate degree, a combined
bachelor and master’s degree, or a certificate
program, for use by each Center. The Secretary shall disseminate such curricula to
other accredited schools of public health and
other health professions schools determined
appropriate by the Secretary, for voluntary
use by such schools.
(4) Core competency-based training program
The Secretary, in collaboration with the
Centers and other public or private entities
shall facilitate the development of a competency-based training program to train public health practitioners. The Centers shall use
such training program to train public health
practitioners. The Secretary shall disseminate
such training program to other accredited
schools of public health, health professions
schools, and other public or private entities as
determined by the Secretary, for voluntary
use by such entities.
(5) Content of core curricula and training program
The Secretary shall ensure that the core
curricula and training program established
pursuant to this subsection respond to the
needs of State, local, and tribal public health
authorities and integrate and emphasize es-

Page 208

sential public health security capabilities consistent with section 300hh–1(b)(2) of this title.
(6) Academic-workforce communication
As a condition of receiving funding from the
Secretary under this subsection, a Center
shall collaborate with a State, local, or tribal
public health department to—
(A) define the public health preparedness
and response needs of the community involved;
(B) assess the extent to which such needs
are fulfilled by existing preparedness and response activities of such school or health department, and how such activities may be
improved;
(C) prior to developing new materials or
trainings, evaluate and utilize relevant materials and trainings developed by others
Centers; and
(D) evaluate community impact and the
effectiveness of any newly developed materials or trainings.
(7) Public health systems research
In consultation with relevant public and private entities, the Secretary shall define the
existing knowledge base for public health preparedness and response systems, and establish
a research agenda based on Federal, State,
local, and tribal public health preparedness
priorities. As a condition of receiving funding
from the Secretary under this subsection, a
Center shall conduct public health systems research that is consistent with the agenda described under this paragraph.
(e) Accelerated research and development on
priority pathogens and countermeasures
(1) In general
With respect to pathogens of potential use in
a bioterrorist attack, and other agents that
may cause a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a) of this section, shall conduct, and
award grants, contracts, or cooperative agreements for, research, investigations, experiments, demonstrations, and studies in the
health sciences relating to—
(A) the epidemiology and pathogenesis of
such pathogens;
(B) the sequencing of the genomes, or
other DNA analysis, or other comparative
analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the
working group established in subsection (a)
of this section), in collaboration and coordination with the activities of the Department
of Defense and the Joint Genome Institute of
the Department of Energy;
(C) the development of priority countermeasures; and
(D) other relevant areas of research;
with consideration given to the needs of children and other vulnerable populations.
(2) Priority
The Secretary shall give priority under this
section to the funding of research and other
studies related to priority countermeasures.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Role of Department of Veterans Affairs
In carrying out paragraph (1), the Secretary
shall consider using the biomedical research
and development capabilities of the Department of Veterans Affairs, in conjunction with
that Department’s affiliations with healthprofessions universities. When advantageous
to the Government in furtherance of the purposes of such paragraph, the Secretary may
enter into cooperative agreements with the
Secretary of Veterans Affairs to achieve such
purposes.
(4) Priority countermeasures
For purposes of this section, the term ‘‘priority countermeasure’’ means a drug, biological product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that the Secretary determines to be—
(A) a priority to treat, identify, or prevent
infection by a biological agent or toxin listed pursuant to section 262a(a)(1) of this title,
or harm from any other agent that may
cause a public health emergency; or
(B) a priority to treat, identify, or prevent
conditions that may result in adverse health
consequences or death and may be caused by
the administering of a drug, biological product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that is a priority under subparagraph (A).
(f) Authorization of appropriations
(1) Fiscal year 2007
There are authorized to be appropriated to
carry out this section for fiscal year 2007—
(A) to carry out subsection (a)—
(i) $5,000,000 to carry out paragraphs (1)
through (4); and
(ii) $7,000,000 to carry out paragraph (5);
(B) to carry out subsection (c), $3,000,000;
and
(C) to carry out subsection (d), $31,000,000,
of which $5,000,000 shall be used to carry out
paragraphs (3) through (5) of such subsection.
(2) Subsequent fiscal years
There are authorized to be appropriated such
sums as may be necessary to carry out this
section for fiscal year 2008 and each subsequent fiscal year.
(July 1, 1944, ch. 373, title III, § 319F, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2321; amended Pub. L. 107–188, title I,
§§ 104(a) 105, 108, 111(3), 125, June 12, 2002, 116
Stat. 605, 606, 609, 611, 614; Pub. L. 108–276, § 2(d),
July 21, 2004, 118 Stat. 842; Pub. L. 109–417, title
III, §§ 301(d), (e), 304, Dec. 19, 2006, 120 Stat. 2854,
2855, 2859.)
AMENDMENTS
2006—Subsec. (a). Pub. L. 109–417, § 304(1), added subsec. (a) and struck out heading and text of former subsec. (a) which established a working group on bioterrorism and other public health emergencies.
Subsec. (b)(2). Pub. L. 109–417, § 301(d)(1), substituted
‘‘At-Risk Individuals and Public Health Emergencies’’
for ‘‘Children and Terrorism’’ in heading.
Subsec. (b)(2)(A). Pub. L. 109–417, § 301(d)(2), substituted ‘‘At-Risk Individuals and Public Health Emergencies’’ for ‘‘Children and Terrorism’’.

§ 247d–6

Subsec. (b)(2)(B)(i). Pub. L. 109–417, § 301(d)(3)(A), substituted ‘‘public health emergencies as they relate to
at-risk individuals’’ for ‘‘bioterrorism as it relates to
children’’.
Subsec. (b)(2)(B)(ii), (iii). Pub. L. 109–417, § 301(d)(3)(B),
(C), substituted ‘‘at-risk individuals’’ for ‘‘children’’.
Subsec. (b)(2)(C). Pub. L. 109–417, § 301(d)(4), substituted ‘‘at-risk populations’’ for ‘‘children, and child
health experts on infectious disease, environmental
health, toxicology, and other relevant professional disciplines’’.
Subsec. (b)(2)(D). Pub. L. 109–417, § 301(d)(5), substituted ‘‘six years’’ for ‘‘one year’’.
Subsec. (b)(3)(B). Pub. L. 109–417, § 301(e), struck out
‘‘and the working group under subsection (a) of this
section’’ after ‘‘Secretary’’.
Subsecs. (c) to (h). Pub. L. 109–417, § 304(2)–(4), added
subsecs. (c), (d), and (f), redesignated subsec. (h) as (e),
and struck out former subsecs. (c) to (g), which related
to: in subsec. (c), development of communication strategy; in subsec. (d), Federal Internet site on bioterrorism; in subsec. (e), grants to increase capacity to detect, diagnose, and respond to acts of bioterrorism; in
subsec. (f), assistance to State and local health agencies to enable effective response to attacks; and, in subsec. (g), education and training activities.
Subsecs. (i), (j). Pub. L. 109–417, § 304(5), struck out
subsecs. (i) and (j) which related to report to congressional committees on public health and medical consequences of a bioterrorist attack and the supplementary
nature of funds appropriated under this section, respectively.
2004—Subsec. (a)(1). Pub. L. 108–276, § 2(d)(1), inserted
‘‘the Secretary of Homeland Security,’’ after ‘‘Management Agency,’’ in introductory provisions.
Subsec. (h)(4)(B). Pub. L. 108–276, § 2(d)(2), substituted
‘‘to treat, identify, or prevent conditions’’ for ‘‘to diagnose conditions’’.
2002—Subsec. (a). Pub. L. 107–188, § 108, added subsec.
(a) and struck out heading and text of former subsec.
(a). Text read as follows: ‘‘The Secretary, in coordination with the Secretary of Defense, shall establish a
joint interdepartmental working group on preparedness
and readiness for the medical and public health effects
of a bioterrorist attack on the civilian population.
Such joint working group shall—
‘‘(1) coordinate research on pathogens likely to be
used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens;
‘‘(2) coordinate research and development into
equipment to detect pathogens likely to be used in a
bioterrorist attack on the civilian population and
protect against infection from such pathogens;
‘‘(3) develop shared standards for equipment to detect and to protect against infection from pathogens
likely to be used in a bioterrorist attack on the civilian population; and
‘‘(4) coordinate the development, maintenance, and
procedures for the release of, strategic reserves of
vaccines, drugs, and medical supplies which may be
needed rapidly after a bioterrorist attack upon the civilian population.’’
Subsec. (b). Pub. L. 107–188, § 104(a)(1), (3), added subsec. (b) and struck out former subsec. (b) which related
to establishment, functions, membership, and coordination of a working group on the public health and medical consequences of bioterrorism.
Subsecs. (c), (d). Pub. L. 107–188, § 104(a)(3), added subsecs. (c) and (d). Former subsecs. (c) and (d) redesignated (e) and (f), respectively.
Subsec. (e). Pub. L. 107–188, § 104(a)(2), redesignated
subsec. (c) as (e). Former subsec. (e) redesignated (g).
Subsec. (e)(2). Pub. L. 107–188, § 111(3), which directed
the amendment of section 391F(e)(2) of the Public
Health Service Act by striking out ‘‘or’’ after ‘‘clinic,’’
and inserting before period ‘‘, professional organization
or society, school or program that trains medical laboratory personnel, private accrediting organization, or
other nonprofit private institution or entity meeting
criteria established by the Secretary’’, was executed to

§ 247d–6a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

subsec. (e)(2) of this section, which is section 319F(e)(2)
of the Act, to reflect the probable intent of Congress.
Subsec. (f). Pub. L. 107–188, § 104(a)(2), redesignated
subsec. (d) as (f). Former subsec. (f) redesignated (h).
Subsec. (g). Pub. L. 107–188, § 105, amended heading
and text of subsec. (g) generally. Prior to amendment,
text read as follows: ‘‘The Secretary, in collaboration
with members of the working group described in subsection (b) of this section, and professional organizations and societies, shall—
‘‘(1) develop and implement educational programs
to instruct public health officials, medical professionals, and other personnel working in health care
facilities in the recognition and care of victims of a
bioterrorist attack; and
‘‘(2) develop and implement programs to train laboratory personnel in the recognition and identification of a potential bioweapon.’’
Pub. L. 107–188, § 104(a)(2), redesignated subsec. (e) as
(g). Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 107–188, § 125, amended heading
and text of subsec. (h) generally. Prior to amendment,
text read as follows: ‘‘The Secretary shall consult with
the working group described in subsection (a) of this
section, to develop priorities for and conduct research,
investigations, experiments, demonstrations, and studies in the health sciences related to—
‘‘(1) the epidemiology and pathogenesis of potential
bioweapons;
‘‘(2) the development of new vaccines or other
therapeutics against pathogens likely to be used in a
bioterrorist attack;
‘‘(3) the development of medical diagnostics to detect potential bioweapons; and
‘‘(4) other relevant research areas.’’
Pub. L. 107–188, § 104(a)(2), redesignated subsec. (f) as
(h). Former subsec. (h) redesignated (j).
Subsec. (i). Pub. L. 107–188, § 104(a)(1), (2), redesignated subsec. (g) as (i) and struck out heading and text
of former subsec. (i). Text read as follows: ‘‘There are
authorized to be appropriated to carry out this section
$215,000,000 for fiscal year 2001, and such sums as may be
necessary for each subsequent fiscal year through
2006.’’
Subsec. (j). Pub. L. 107–188, § 104(a)(2), redesignated
subsec. (h) as (j).
OTHER REPORTS
Pub. L. 107–188, title I, § 101(b)(1), June 12, 2002, 116
Stat. 598, provided that:
‘‘(1) IN GENERAL.—Not later than one year after the
date of the enactment of this Act [June 12, 2002], the
Secretary of Health and Human Services (referred to in
this subsection as the ‘Secretary’) shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning—
‘‘(A) the recommendations and findings of the National Advisory Committee on Children and Terrorism under section 319F(c)(2) of the Public Health
Service Act [probably means subsec. (b)(2) of this section];
‘‘(B) the recommendations and findings of the EPIC
Advisory Committee under section 319F(c)(3) of such
Act [probably means subsec. (b)(3) of this section];
‘‘(C) the characteristics that may render a rural
community uniquely vulnerable to a biological attack, including distance, lack of emergency transport, hospital or laboratory capacity, lack of integration of Federal or State public health networks,
workforce deficits, or other relevant characteristics;
‘‘(D) the characteristics that may render areas or
populations designated as medically underserved populations (as defined in section 330 of such Act [section
254b of this title]) uniquely vulnerable to a biological
attack, including significant numbers of low-income
or uninsured individuals, lack of affordable and accessible health care services, insufficient public and
primary health care resources, lack of integration of

Page 210

Federal or State public health networks, workforce
deficits, or other relevant characteristics;
‘‘(E) the recommendations of the Secretary with respect to additional legislative authority that the Secretary determines is necessary to effectively
strengthen rural communities, or medically underserved populations (as defined in section 330 of such
Act); and
‘‘(F) the need for and benefits of a National Disaster Response Medical Volunteer Service that would
be a private-sector, community-based rapid response
corps of medical volunteers.’’
STUDY REGARDING COMMUNICATIONS ABILITIES OF
PUBLIC HEALTH AGENCIES
Pub. L. 107–188, title I, § 104(b), June 12, 2002, 116 Stat.
606, provided that: ‘‘The Secretary of Health and
Human Services, in consultation with the Federal Communications Commission, the National Telecommunications and Information Administration, and other appropriate Federal agencies, shall conduct a study to determine whether local public health entities have the
ability to maintain communications in the event of a
bioterrorist attack or other public health emergency.
The study shall examine whether redundancies are required in the telecommunications system, particularly
with respect to mobile communications, for public
health entities to maintain systems operability and
connectivity during such emergencies. The study shall
also include recommendations to industry and public
health entities about how to implement such
redundancies if necessary.’’

§ 247d–6a. Authority for use of certain procedures regarding qualified countermeasure
research and development activities
(a) In general
(1) Authority
In conducting and supporting research and
development activities regarding countermeasures under section 247d–6(h) of this title,
the Secretary may conduct and support such
activities in accordance with this section and,
in consultation with the Director of the National Institutes of Health, as part of the program under section 285f of this title, if the activities concern qualified countermeasures.
(2) Definitions
In this section:
(A) Qualified countermeasure
The term ‘‘qualified countermeasure’’
means a drug (as that term is defined by section 321(g)(1) of title 21), biological product
(as that term is defined by section 262(i) of
this title), or device (as that term is defined
by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)
to—
(i) diagnose, mitigate, prevent, or treat
harm from any biological agent (including
organisms that cause an infectious disease) or toxin, chemical, radiological, or
nuclear agent that may cause a public
health emergency affecting national security; or
(ii) diagnose, mitigate, prevent, or treat
harm from a condition that may result in
adverse health consequences or death and
may be caused by administering a drug, biological product, or device that is used as
described in this subparagraph.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Infectious disease
The term ‘‘infectious disease’’ means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus,
or parasite) that is acquired by a person and
that reproduces in that person.
(3) Interagency cooperation
(A) In general
In carrying out activities under this section, the Secretary is authorized, subject to
subparagraph (B), to enter into interagency
agreements and other collaborative undertakings with other agencies of the United
States Government.
(B) Limitation
An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the authorities provided by
this section.
(4) Availability of facilities to the Secretary
In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a biocontainment laboratory or other related or
ancillary specialized research facility that the
Secretary determines necessary for the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary may provide that
the facility that is the object of such grant,
contract, or cooperative agreement shall be
available as needed to the Secretary to respond to public health emergencies affecting
national security.
(5) Transfers of qualified countermeasures
Each agreement for an award of a grant,
contract, or cooperative agreement under section 247d–6(h) of this title for the development
of a qualified countermeasure shall provide
that the recipient of the award will comply
with all applicable export-related controls
with respect to such countermeasure.
(b) Expedited procurement authority
(1) Increased simplified acquisition threshold
for qualified countermeasure procurements
(A) In general
For any procurement by the Secretary of
property or services for use (as determined
by the Secretary) in performing, administering, or supporting qualified countermeasure
research or development activities under
this section that the Secretary determines
necessary to respond to pressing research
and development needs under this section,
the amount specified in section 134 of title
41, as applicable pursuant to section
3101(b)(1)(A) of title 41, shall be deemed to be
$25,000,000 in the administration, with respect to such procurement, of—
(i) section 3305(a)(1) of title 41 and its implementing regulations; and
(ii) section 3101(b)(1)(B) of title 41 and its
implementing regulations.
(B) Application of certain provisions
Notwithstanding subparagraph (A) and the
provision of law and regulations referred to

§ 247d–6a

in such subparagraph, each of the following
provisions shall apply to procurements described in this paragraph to the same extent
that such provisions would apply to such
procurements in the absence of subparagraph (A):
(i) Chapter 37 of title 40 (relating to contract work hours and safety standards).
(ii) Section 8703(a) of title 41.
(iii) Section 4706 of title 41 (relating to
the examination of contractor records).
(iv) Section 3131 of title 40 (relating to
bonds of contractors of public buildings or
works).
(v) Section 3901 of title 41 (relating to
contingent fees to middlemen).
(vi) Section 6962 of this title.
(vii) Section 1354 of title 31 (relating to
the limitation on the use of appropriated
funds for contracts with entities not meeting veterans employment reporting requirements).
(C) Internal controls to be instituted
The Secretary shall institute appropriate
internal controls for procurements that are
under this paragraph, including requirements with regard to documenting the justification for use of the authority in this
paragraph with respect to the procurement
involved.
(D) Authority to limit competition
In conducting a procurement under this
paragraph, the Secretary may not use the
authority provided for under subparagraph
(A) to conduct a procurement on a basis
other than full and open competition unless
the Secretary determines that the mission
of the BioShield Program under the Project
BioShield Act of 2004 would be seriously impaired without such a limitation.
(2) Procedures other than full and open competition
(A) In general
In using the authority provided in section
3304(a)(1) of title 41 to use procedures other
than competitive procedures in the case of a
procurement described in paragraph (1) of
this subsection, the phrase ‘‘available from
only one responsible source’’ in such section
3304(a)(1) shall be deemed to mean ‘‘available
from only one responsible source or only
from a limited number of responsible
sources’’.
(B) Relation to other authorities
The authority under subparagraph (A) is in
addition to any other authority to use procedures other than competitive procedures.
(C) Applicable government-wide regulations
The Secretary shall implement this paragraph in accordance with government-wide
regulations implementing such section
3304(a)(1) (including requirements that offers
be solicited from as many potential sources
as is practicable under the circumstances,
that required notices be published, and that
submitted offers be considered), as such regulations apply to procurements for which an

§ 247d–6a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

agency has authority to use procedures
other than competitive procedures when the
property or services needed by the agency
are available from only one responsible
source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the
agency.
(3) Increased micropurchase threshold
(A) In general
For a procurement described by paragraph
(1), the amount specified in subsections (a),
(d), and (e) of section 1902 of title 41 shall be
deemed to be $15,000 in the administration of
that section with respect to such procurement.
(B) Internal controls to be instituted
The Secretary shall institute appropriate
internal controls for purchases that are
under this paragraph and that are greater
than $2,500.
(C) Exception to preference for purchase
card mechanism
No provision of law establishing a preference for using a Government purchase
card method for purchases shall apply to
purchases that are under this paragraph and
that are greater than $2,500.
(4) Review
(A) Review allowed
Notwithstanding subsection (f) of this section, section 1491 of title 28, and section 3556
of title 31, review of a contracting agency
decision relating to a procurement described
in paragraph (1) may be had only by filing a
protest—
(i) with a contracting agency; or
(ii) with the Comptroller General under
subchapter V of chapter 35 of title 31.
(B) Override of stay of contract award or
performance committed to agency discretion
Notwithstanding section 1491 of title 28
and section 3553 of title 31, the following authorizations by the head of a procuring activity are committed to agency discretion:
(i) An authorization under section
3553(c)(2) of title 31 to award a contract for
a procurement described in paragraph (1)
of this subsection.
(ii) An authorization under section
3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.
(c) Authority to expedite peer review
(1) In general
The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development
needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts)
as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and
likely contribution to the field of qualified

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countermeasure research, in place of the peer
review and advisory council review procedures
that would be required under sections 241(a)(3),
284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and
289c of this title, as applicable to a grant, contract, or cooperative agreement—
(A) that is for performing, administering,
or supporting qualified countermeasure research and development activities; and
(B) the amount of which is not greater
than $1,500,000.
(2) Subsequent phases of research
The Secretary’s determination of whether to
employ expedited peer review with respect to
any subsequent phases of a research grant,
contract, or cooperative agreement under this
section shall be determined without regard to
the peer review procedures used for any prior
peer review of that same grant, contract, or
cooperative agreement. Nothing in the preceding sentence may be construed to impose any
requirement with respect to peer review not
otherwise required under any other law or regulation.
(d) Authority for personal services contracts
(1) In general
For the purpose of performing, administering, or supporting qualified countermeasure
research and development activities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs
under this section, obtain by contract (in accordance with section 3109 of title 5, but without regard to the limitations in such section
on the period of service and on pay) the personal services of experts or consultants who
have scientific or other professional qualifications, except that in no case shall the compensation provided to any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.
(2) Federal Tort Claims Act coverage
(A) In general
A person carrying out a contract under
paragraph (1), and an officer, employee, or
governing board member of such person,
shall, subject to a determination by the Secretary, be deemed to be an employee of the
Department of Health and Human Services
for purposes of claims under sections 1346(b)
and 2672 of title 28 for money damages for
personal injury, including death, resulting
from performance of functions under such
contract.
(B) Exclusivity of remedy
The remedy provided by subparagraph (A)
shall be exclusive of any other civil action
or proceeding by reason of the same subject
matter against the entity involved (person,
officer, employee, or governing board member) for any act or omission within the scope
of the Federal Tort Claims Act.
(C) Recourse in case of gross misconduct or
contract violation
(i) In general
Should payment be made by the United
States to any claimant bringing a claim

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under this paragraph, either by way of administrative determination, settlement, or
court judgment, the United States shall
have, notwithstanding any provision of
State law, the right to recover against any
entity identified in subparagraph (B) for
that portion of the damages so awarded or
paid, as well as interest and any costs of
litigation, resulting from the failure of
any such entity to carry out any obligation or responsibility assumed by such entity under a contract with the United
States or from any grossly negligent or
reckless conduct or intentional or willful
misconduct on the part of such entity.
(ii) Venue
The United States may maintain an action under this subparagraph against such
entity in the district court of the United
States in which such entity resides or has
its principal place of business.
(3) Internal controls to be instituted
(A) In general
The Secretary shall institute appropriate
internal controls for contracts under this
subsection, including procedures for the Secretary to make a determination of whether a
person, or an officer, employee, or governing
board member of a person, is deemed to be
an employee of the Department of Health
and Human Services pursuant to paragraph
(2).
(B) Determination of employee status to be
final
A determination by the Secretary under
subparagraph (A) that a person, or an officer, employee, or governing board member of
a person, is or is not deemed to be an employee of the Department of Health and
Human Services shall be final and binding
on the Secretary and the Attorney General
and other parties to any civil action or proceeding.
(4) Number of personal services contracts limited
The number of experts and consultants
whose personal services are obtained under
paragraph (1) shall not exceed 30 at any time.
(e) Streamlined personnel authority
(1) In general
In addition to any other personnel authorities, the Secretary may, as the Secretary determines necessary to respond to pressing
qualified countermeasure research and development needs under this section, without regard to those provisions of title 5 governing
appointments in the competitive service, and
without regard to the provisions of chapter 51
and subchapter III of chapter 53 of such title
relating to classification and General Schedule pay rates, appoint professional and technical employees, not to exceed 30 such employees at any time, to positions in the National
Institutes of Health to perform, administer, or
support qualified countermeasure research and
development activities in carrying out this
section.

§ 247d–6a

(2) Limitations
The authority provided for under paragraph
(1) shall be exercised in a manner that—
(A) recruits and appoints individuals based
solely on their abilities, knowledge, and
skills;
(B) does not discriminate for or against
any applicant for employment on any basis
described in section 2302(b)(1) of title 5;
(C) does not allow an official to appoint an
individual who is a relative (as defined in
section 3110(a)(3) of such title) of such official;
(D) does not discriminate for or against an
individual because of the exercise of any activity described in paragraph (9) or (10) of
section 2302(b) of such title; and
(E) accords a preference, among equally
qualified persons, to persons who are preference eligibles (as defined in section 2108(3)
of such title).
(3) Internal controls to be instituted
The Secretary shall institute appropriate internal controls for appointments under this
subsection.
(f) Actions committed to agency discretion
Actions by the Secretary under the authority
of this section are committed to agency discretion.
(July 1, 1944, ch. 373, title III, § 319F–1, as added
Pub. L. 108–276, § 2(a), July 21, 2004, 118 Stat. 835;
amended Pub. L. 109–417, title IV, § 403(a), Dec.
19, 2006, 120 Stat. 2874.)
REFERENCES IN TEXT
The Project BioShield Act of 2004, referred to in subsec. (b)(1)(D), is Pub. L. 108–276, July 21, 2004, 118 Stat.
835. For complete classification of this Act to the Code,
see Short Title of 2004 Amendments note set out under
section 201 of this title and Tables.
The Federal Tort Claims Act, referred to in subsec.
(d)(2), is title IV of act Aug. 2, 1946, ch. 753, 60 Stat. 842,
which was classified principally to chapter 20 (§§ 921,
922, 931–934, 941–946) of former Title 28, Judicial Code
and Judiciary. Title IV of act Aug. 2, 1946, was substantially repealed and reenacted as sections 1346(b) and
2671 et seq. of Title 28, Judiciary and Judicial Procedure, by act June 25, 1948, ch. 646, 62 Stat. 992, the first
section of which enacted Title 28. The Federal Tort
Claims Act is also commonly used to refer to chapter
171 of Title 28, Judiciary and Judicial Procedure. For
complete classification of title IV to the Code, see
Tables. For distribution of former sections of Title 28
into the revised Title 28, see Table at the beginning of
Title 28.
CODIFICATION
In subsec. (b)(1)(A), ‘‘section 134 of title 41’’ substituted for ‘‘section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11))’’ and ‘‘section
3101(b)(1)(A) of title 41’’ substituted for ‘‘section 302A(a)
of the Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 252a(a))’’ on authority of Pub. L.
111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (b)(1)(A)(i), ‘‘section 3305(a)(1) of title 41’’
substituted for ‘‘section 303(g)(1)(A) of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 253(g)(1)(A))’’ on authority of Pub. L. 111–350,
§ 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted
Title 41, Public Contracts.
In subsec. (b)(1)(A)(ii), ‘‘section 3101(b)(1)(B) of title
41’’ substituted for ‘‘section 302A(b) of such Act (41

§ 247d–6a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

U.S.C. 252a(b))’’ on authority of Pub. L. 111–350, § 6(c),
Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41,
Public Contracts.
In subsec. (b)(1)(B)(ii), ‘‘Section 8703(a) of title 41’’
substituted for ‘‘Subsections (a) and (b) of section 7 of
the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b))’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (b)(1)(B)(iii), ‘‘Section 4706 of title 41’’ substituted for ‘‘Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 254d)’’ on
authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.
In subsec. (b)(1)(B)(v), ‘‘Section 3901 of title 41’’ substituted for ‘‘Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949
(41 U.S.C. 254(a))’’ on authority of Pub. L. 111–350, § 6(c),
Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41,
Public Contracts.
In subsec. (b)(2)(A), ‘‘section 3304(a)(1) of title 41’’ substituted for ‘‘section 303(c)(1) of title III of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 253(c)(1))’’ and ‘‘such section 3304(a)(1)’’ substituted for ‘‘such section 303(c)(1)’’ on authority of
Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which
Act enacted Title 41, Public Contracts.
In subsec. (b)(2)(C), ‘‘such section 3304(a)(1)’’ substituted for ‘‘such section 303(c)(1)’’ on authority of
Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which
Act enacted Title 41, Public Contracts.
In subsec. (b)(3)(A), ‘‘subsections (a), (d), and (e) of
section 1902 of title 41’’ substituted for ‘‘subsections (c),
(d), and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428)’’ on authority of
Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which
Act enacted Title 41, Public Contracts.
AMENDMENTS
2006—Subsec. (a)(2). Pub. L. 109–417 added par. (2) and
struck out heading and text of former par. (2). Text
read as follows: ‘‘For purposes of this section, the term
‘qualified countermeasure’ means a drug (as that term
is defined by section 321(g)(1) of title 21), biological
product (as that term is defined by section 262(i) of this
title), or device (as that term is defined by section
321(h) of title 21) that the Secretary determines to be a
priority (consistent with sections 182(2) and 184(a) of
title 6) to—
‘‘(A) treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that
may cause a public health emergency affecting national security; or
‘‘(B) treat, identify, or prevent harm from a condition that may result in adverse health consequences
or death and may be caused by administering a drug,
biological product, or device that is used as described
in subparagraph (A).’’
RULE OF CONSTRUCTION
Pub. L. 108–276, § 2(e), July 21, 2004, 118 Stat. 842, provided that: ‘‘Nothing in this section [enacting this section and amending sections 247d–6, 287a–2, and 300aa–6
of this title] has any legal effect on sections 302(2),
302(4), 304(a), or 304(b) of the Homeland Security Act of
2002 [6 U.S.C. 182(2), (4), 184(a), (b)].’’
COLLABORATION AND COORDINATION
Pub. L. 109–417, title IV, § 405, Dec. 19, 2006, 120 Stat.
2875, provided that:
‘‘(a) LIMITED ANTITRUST EXEMPTION.—
‘‘(1) MEETINGS AND CONSULTATIONS TO DISCUSS SECURITY COUNTERMEASURES, QUALIFIED COUNTERMEASURES,
OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT DEVELOPMENT.—
‘‘(A) AUTHORITY TO CONDUCT MEETINGS AND CONSULTATIONS.—The Secretary of Health and Human
Services (referred to in this subsection as the ‘Secretary’), in coordination with the Attorney General

Page 214

and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in section 319F–2 of the Public
Health Service Act (42 U.S.C. 247d–6b)) (as amended
by this Act), a qualified countermeasure (as defined
in section 319F–1 of the Public Health Service Act
(42 U.S.C. 247d–6a)) (as amended by this Act), or a
qualified pandemic or epidemic product (as defined
in section 319F–3 of the Public Health Service Act
(42 U.S.C. 247d–6d)) for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The Secretary
may convene such meeting or consultation at the
request of the Secretary of Homeland Security, the
Attorney General, the Chairman of the Federal
Trade Commission (referred to in this section as
the ‘Chairman’), or any interested person, or upon
initiation by the Secretary. The Secretary shall
give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney
General, the Chairman, and the Secretary of Homeland Security.
‘‘(B) MEETING AND CONSULTATION CONDITIONS.—A
meeting or consultation conducted under subparagraph (A) shall—
‘‘(i) be chaired or, in the case of a consultation,
facilitated by the Secretary;
‘‘(ii) be open to persons involved in the development, manufacture, distribution, purchase, or
storage of a countermeasure or product, as determined by the Secretary;
‘‘(iii) be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;
‘‘(iv) be limited to discussions involving covered
activities; and
‘‘(v) be conducted in such manner as to ensure
that no national security, confidential commercial, or proprietary information is disclosed outside the meeting or consultation.
‘‘(C) LIMITATION.—The Secretary may not require
participants to disclose confidential commercial or
proprietary information.
‘‘(D) TRANSCRIPT.—The Secretary shall maintain
a complete verbatim transcript of each meeting or
consultation conducted under this subsection. Such
transcript (or a portion thereof) shall not be disclosed under section 552 of title 5, United States
Code, to the extent that the Secretary, in consultation with the Attorney General and the Secretary
of Homeland Security, determines that disclosure
of such transcript (or portion thereof) would pose a
threat to national security. The transcript (or portion thereof) with respect to which the Secretary
has made such a determination shall be deemed to
be information described in subsection (b)(3) of such
section 552.
‘‘(E) EXEMPTION.—
‘‘(i) IN GENERAL.—Subject to clause (ii), it shall
not be a violation of the antitrust laws for any
person to participate in a meeting or consultation
conducted in accordance with this paragraph.
‘‘(ii) LIMITATION.—Clause (i) shall not apply to
any agreement or conduct that results from a
meeting or consultation and that is not covered
by an exemption granted under paragraph (4).
‘‘(2) SUBMISSION OF WRITTEN AGREEMENTS.—The Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1)
to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself,
any submission shall include—
‘‘(A) an explanation of the intended purpose of
the agreement;
‘‘(B) a specific statement of the substance of the
agreement;
‘‘(C) a description of the methods that will be utilized to achieve the objectives of the agreement;
‘‘(D) an explanation of the necessity for a cooperative effort among the particular participating per-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

sons to achieve the objectives of the agreement;
and
‘‘(E) any other relevant information determined
necessary by the Attorney General, in consultation
with the Chairman and the Secretary.
‘‘(3) EXEMPTION FOR CONDUCT UNDER APPROVED
AGREEMENT.—It shall not be a violation of the antitrust laws for a person to engage in conduct in accordance with a written agreement to the extent that
such agreement has been granted an exemption under
paragraph (4), during the period for which the exemption is in effect.
‘‘(4) ACTION ON WRITTEN AGREEMENTS.—
‘‘(A) IN GENERAL.—The Attorney General, in consultation with the Chairman, shall grant, deny,
grant in part and deny in part, or propose modifications to an exemption request regarding a written
agreement submitted under paragraph (2), in a written statement to the Secretary, within 15 business
days of the receipt of such request. An exemption
granted under this paragraph shall take effect immediately.
‘‘(B) EXTENSION.—The Attorney General may extend the 15-day period referred to in subparagraph
(A) for an additional period of not to exceed 10 business days.
‘‘(C) DETERMINATION.—An exemption shall be
granted regarding a written agreement submitted
in accordance with paragraph (2) only to the extent
that the Attorney General, in consultation with the
Chairman and the Secretary, finds that the conduct
that will be exempted will not have any substantial
anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
‘‘(5) LIMITATION ON AND RENEWAL OF EXEMPTIONS.—
An exemption granted under paragraph (4) shall be
limited to covered activities, and such exemption
shall be renewed (with modifications, as appropriate,
consistent with the finding described in paragraph
(4)(C)), on the date that is 3 years after the date on
which the exemption is granted unless the Attorney
General in consultation with the Chairman determines that the exemption should not be renewed
(with modifications, as appropriate) considering the
factors described in paragraph (4).
‘‘(6) AUTHORITY TO OBTAIN INFORMATION.—Consideration by the Attorney General for granting or renewing an exemption submitted under this section shall
be considered an antitrust investigation for purposes
of the Antitrust Civil Process Act (15 U.S.C. 1311 et
seq.).
‘‘(7) LIMITATION ON PARTIES.—The use of any information acquired under an agreement for which an exemption has been granted under paragraph (4), for
any purpose other than specified in the exemption,
shall be subject to the antitrust laws and any other
applicable laws.
‘‘(8) REPORT.—Not later than one year after the
date of enactment of this Act [Dec. 19, 2006] and biannually thereafter, the Attorney General and the
Chairman shall report to Congress on the use of the
exemption from the antitrust laws provided by this
subsection.
‘‘(b) SUNSET.—The applicability of this section shall
expire at the end of the 6-year period that begins on the
date of enactment of this Act [Dec. 19, 2006].
‘‘(c) DEFINITIONS.—In this section:
‘‘(1) ANTITRUST LAWS.—The term ‘antitrust laws’—
‘‘(A) has the meaning given such term in subsection (a) of the first section of the Clayton Act (15
U.S.C. 12(a)), except that such term includes section
5 of the Federal Trade Commission Act (15 U.S.C.
45) to the extent such section 5 applies to unfair
methods of competition; and
‘‘(B) includes any State law similar to the laws
referred to in subparagraph (A).
‘‘(2) COUNTERMEASURE OR PRODUCT.—The term
‘countermeasure or product’ refers to a security
countermeasure, qualified countermeasure, or quali-

§ 247d–6a

fied pandemic or epidemic product (as those terms
are defined in subsection (a)(1)).
‘‘(3) COVERED ACTIVITIES.—
‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the term ‘covered activities’ includes any
activity relating to the development, manufacture,
distribution, purchase, or storage of a countermeasure or product.
‘‘(B) EXCEPTION.—The term ‘covered activities’
shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an
agreement for which an exemption has been granted under subsection (a)(4), the following activities
involving 2 or more persons:
‘‘(i) Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry
out covered activities—
‘‘(I) with respect to a countermeasure or product regarding which such meeting or consultation is being conducted; or
‘‘(II) that are described in the agreement as
exempted.
‘‘(ii) Entering into any agreement or engaging
in any other conduct—
‘‘(I) to restrict or require the sale, licensing,
or sharing of inventions, developments, products, processes, or services not developed
through, produced by, or distributed or sold
through such covered activities; or
‘‘(II) to restrict or require participation, by
any person participating in such covered activities, in other research and development activities, except as reasonably necessary to prevent
the misappropriation of proprietary information contributed by any person participating in
such covered activities or of the results of such
covered activities.
‘‘(iii) Entering into any agreement or engaging
in any other conduct allocating a market with a
competitor that is not expressly exempted from
the antitrust laws under subsection (a)(4).
‘‘(iv) Exchanging information among competitors relating to production (other than production by such covered activities) of a product,
process, or service if such information is not reasonably necessary to carry out such covered activities.
‘‘(v) Entering into any agreement or engaging
in any other conduct restricting, requiring, or
otherwise involving the production of a product,
process, or service that is not expressly exempted
from the antitrust laws under subsection (a)(4).
‘‘(vi) Except as otherwise provided in this subsection, entering into any agreement or engaging
in any other conduct to restrict or require participation by any person participating in such
covered activities, in any unilateral or joint activity that is not reasonably necessary to carry
out such covered activities.
‘‘(vii) Entering into any agreement or engaging
in any other conduct restricting or setting the
price at which a countermeasure or product is offered for sale, whether by bid or otherwise.’’
OUTREACH
Pub. L. 108–276, § 6, July 21, 2004, 118 Stat. 862, provided that: ‘‘The Secretary of Health and Human Services shall develop outreach measures to ensure to the
extent practicable that diverse institutions, including
Historically Black Colleges and Universities and those
serving large proportions of Black or African Americans, American Indians, Appalachian Americans, Alaska Natives, Asians, Native Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other underrepresented populations, are meaningfully aware of
available research and development grants, contracts,
cooperative agreements, and procurements conducted
under sections 2 and 3 of this Act [enacting this section

§ 247d–6b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and section 320 of Title 6, Domestic Security, amending
sections 247d–6, 247d–6b, 287a–2, and 300aa–6 of this title
and sections 312 and 313 of Title 6, renumbering section
300hh–12 of this title as section 247d–6b of this title, and
enacting provisions set out as notes under this section
and section 247d–6b of this title].’’
RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN
BIOMEDICAL COUNTERMEASURES
Pub. L. 108–276, § 7, July 21, 2004, 118 Stat. 863, provided that: ‘‘Upon the award of any grant, contract, or
cooperative agreement under section 2 or 3 of this Act
[enacting this section and section 320 of Title 6, Domestic Security, amending sections 247d–6, 247d–6b, 287a–2,
and 300aa–6 of this title and sections 312 and 313 of Title
6, renumbering section 300hh–12 of this title as section
247d–6b of this title, and enacting provisions set out as
notes under this section and section 247d–6b of this
title] for the research, development, or procurement of
a qualified countermeasure or a security countermeasure (as those terms are defined in this Act [see
Short Title of 2004 Amendments note set out under section 201 of this title]), the Secretary of Health and
Human Services shall, in consultation with the heads
of other appropriate Federal agencies, determine
whether the countermeasure involved in such grant,
contract, or cooperative agreement is subject to existing export-related controls and, if not, may make a recommendation to the appropriate Federal agency or
agencies that such countermeasure should be included
on the list of controlled items subject to such controls.’’
ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF UNNECESSARY DUPLICATION IN PROGRAMS
DESIGNED TO PROTECT THE HOMELAND FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR
AGENTS
Pub. L. 108–276, § 8, July 21, 2004, 118 Stat. 863, provided that:
‘‘(a) ENSURING COORDINATION OF PROGRAMS.—The Secretary of Health and Human Services, the Secretary of
Homeland Security, and the Secretary of Defense shall
ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs to identify potential domestic threats from biological, chemical, radiological or
nuclear agents, detect domestic incidents involving
such agents, analyze such incidents, and develop necessary countermeasures. The aforementioned Secretaries shall further ensure that information and technology possessed by the Departments relevant to these
activities are shared with the other Departments.
‘‘(b) DESIGNATION OF AGENCY COORDINATION OFFICER.—
The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Defense shall each designate an officer or employee of
their respective Departments who shall coordinate,
through regular meetings and communications, with
the other aforementioned Departments such programs
and activities carried out by their Departments.’’

§ 247d–6b. Strategic National Stockpile and security countermeasure procurements
(a) Strategic National Stockpile
(1) In general
The Secretary, in collaboration with the Director of the Centers for Disease Control and
Prevention, and in coordination with the Secretary of Homeland Security (referred to in
this section as the ‘‘Homeland Security Secretary’’), shall maintain a stockpile or stockpiles of drugs, vaccines and other biological
products, medical devices, and other supplies
in such numbers, types, and amounts as are
determined by the Secretary to be appropriate

Page 216

and practicable, taking into account other
available sources, to provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the
event of a bioterrorist attack or other public
health emergency. The Secretary shall conduct an annual review (taking into account atrisk individuals) of the contents of the stockpile, including non-pharmaceutical supplies,
and make necessary additions or modifications to the contents based on such review.
(2) Procedures
The Secretary, in managing the stockpile
under paragraph (1), shall—
(A) consult with the working group under
section 247d–6(a) of this title;
(B) ensure that adequate procedures are
followed with respect to such stockpile for
inventory management and accounting, and
for the physical security of the stockpile;
(C) in consultation with Federal, State,
and local officials, take into consideration
the timing and location of special events;
(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis
to ensure that emerging threats, advanced
technologies, and new countermeasures are
adequately considered;
(E) devise plans for the effective and timely supply-chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public
and private health care infrastructure;
(F) deploy the stockpile as required by the
Secretary of Homeland Security to respond
to an actual or potential emergency;
(G) deploy the stockpile at the discretion
of the Secretary to respond to an actual or
potential public health emergency or other
situation in which deployment is necessary
to protect the public health or safety; and
(H) ensure the adequate physical security
of the stockpile.
(b) Smallpox vaccine development
(1) In general
The Secretary shall award contracts, enter
into cooperative agreements, or carry out
such other activities as may reasonably be required in order to ensure that the stockpile
under subsection (a) of this section includes an
amount of vaccine against smallpox as determined by such Secretary to be sufficient to
meet the health security needs of the United
States.
(2) Rule of construction
Nothing in this section shall be construed to
limit the private distribution, purchase, or
sale of vaccines from sources other than the
stockpile described in subsection (a) of this
section.
(c) Additional authority regarding procurement
of certain countermeasures; availability of
special reserve fund
(1) In general
(A) Use of fund
A security countermeasure may, in accordance with this subsection, be procured

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with amounts in the special reserve fund
under paragraph (10).
(B) Security countermeasure
For purposes of this subsection, the term
‘‘security countermeasure’’ means a drug (as
that term is defined by section 201(g)(1) of
the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1))), biological product (as
that term is defined by section 262(i) of this
title), or device (as that term is defined by
section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h))) that—
(i)(I) the Secretary determines to be a
priority (consistent with sections 182(2)
and 184(a) of title 6) to diagnose, mitigate,
prevent, or treat harm from any biological, chemical, radiological, or nuclear
agent identified as a material threat under
paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by
administering a drug, biological product,
or device against such an agent;
(II) the Secretary determines under
paragraph (2)(B)(ii) to be a necessary countermeasure; and
(III)(aa) is approved or cleared under
chapter V of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or
(bb) is a countermeasure for which the
Secretary determines that sufficient and
satisfactory clinical experience or research
data (including data, if available, from
pre-clinical and clinical trials) support a
reasonable conclusion that the countermeasure will qualify for approval or licensing within eight years after the date of a
determination under paragraph (5); or
(ii) is authorized for emergency use
under section 564 of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C.
360bbb–3].
(2) Determination of material threats
(A) Material threat
The Homeland Security Secretary, in consultation with the Secretary and the heads
of other agencies as appropriate, shall on an
ongoing basis—
(i) assess current and emerging threats
of chemical, biological, radiological, and
nuclear agents; and
(ii) determine which of such agents
present a material threat against the
United States population sufficient to affect national security.
(B) Public health impact; necessary countermeasures
The Secretary shall on an ongoing basis—
(i) assess the potential public health consequences for the United States population
of exposure to agents identified under subparagraph (A)(ii); and
(ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health.

§ 247d–6b

(C) Notice to Congress
The Secretary and the Homeland Security
Secretary shall promptly notify the designated congressional committees (as defined in paragraph (10)) that a determination
has been made pursuant to subparagraph (A)
or (B).
(D) Assuring access to threat information
In making the assessment and determination required under subparagraph (A), the
Homeland Security Secretary shall use all
relevant information to which such Secretary is entitled under section 122 of title 6,
including but not limited to information, regardless of its level of classification, relating to current and emerging threats of
chemical, biological, radiological, and nuclear agents.
(3) Assessment of availability and appropriateness of countermeasures
(A) In general
The Secretary, in consultation with the
Homeland Security Secretary, shall assess
on an ongoing basis the availability and appropriateness of specific countermeasures to
address specific threats identified under
paragraph (2).
(B) Information
The Secretary shall institute a process for
making publicly available the results of assessments under subparagraph (A) while
withholding such information as—
(i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
(ii) would otherwise be exempt from disclosure under section 552 of title 5.
(4) Call for development of countermeasures;
commitment for recommendation for procurement
(A) Proposal to the President
If, pursuant to an assessment under paragraph (3), the Homeland Security Secretary
and the Secretary make a determination
that a countermeasure would be appropriate
but is either currently not developed or unavailable for procurement as a security
countermeasure or is approved, licensed, or
cleared only for alternative uses, such Secretaries may jointly submit to the President
a proposal to—
(i) issue a call for the development of
such countermeasure; and
(ii) make a commitment that, upon the
first development of such countermeasure
that meets the conditions for procurement
under paragraph (5), the Secretaries will,
based in part on information obtained pursuant to such call, make a recommendation under paragraph (6) that the special
reserve fund under paragraph (10) be made
available for the procurement of such
countermeasure.
(B) Countermeasure specifications
The Homeland Security Secretary and the
Secretary shall, to the extent practicable,
include in the proposal under subparagraph
(A)—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) estimated quantity of purchase (in
the form of number of doses or number of
effective courses of treatments regardless
of dosage form);
(ii) necessary measures of minimum
safety and effectiveness;
(iii) estimated price for each dose or effective course of treatment regardless of
dosage form; and
(iv) other information that may be necessary to encourage and facilitate research, development, and manufacture of
the countermeasure or to provide specifications for the countermeasure.
(C) Presidential approval
If the President approves a proposal under
subparagraph (A), the Homeland Security
Secretary and the Secretary shall make
known to persons who may respond to a call
for the countermeasure involved—
(i) the call for the countermeasure;
(ii) specifications for the countermeasure under subparagraph (B); and
(iii) the commitment described in subparagraph (A)(ii).
(5) Secretary’s determination of countermeasures appropriate for funding from
special reserve fund
(A) In general
The Secretary, in accordance with the provisions of this paragraph, shall identify specific security countermeasures that the Secretary determines, in consultation with the
Homeland Security Secretary, to be appropriate for inclusion in the stockpile under
subsection (a) of this section pursuant to
procurements made with amounts in the
special reserve fund under paragraph (10) (referred to in this subsection individually as a
‘‘procurement under this subsection’’).
(B) Requirements
In making a determination under subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and
consider the following:
(i) The quantities of the product that
will be needed to meet the stockpile needs.
(ii) The feasibility of production and delivery within eight years of sufficient
quantities of the product.
(iii) Whether there is a lack of a significant commercial market for the product
at the time of procurement, other than as
a security countermeasure.
(6) Recommendation for President’s approval
(A) Recommendation for procurement
In the case of a security countermeasure
that the Secretary has, in accordance with
paragraphs (3) and (5), determined to be appropriate for procurement under this subsection, the Homeland Security Secretary
and the Secretary shall jointly submit to the
President, in coordination with the Director
of the Office of Management and Budget, a
recommendation that the special reserve
fund under paragraph (10) be made available
for the procurement of such countermeasure.

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(B) Presidential approval
The special reserve fund under paragraph
(10) is available for a procurement of a security countermeasure only if the President
has approved a recommendation under subparagraph (A) regarding the countermeasure.
(C) Notice to designated congressional committees
The Secretary and the Homeland Security
Secretary shall notify the designated congressional committees of each decision of
the President to approve a recommendation
under subparagraph (A). Such notice shall
include an explanation of the decision to
make available the special reserve fund
under paragraph (10) for procurement of such
a countermeasure, including, where available, the number of, nature of, and other information concerning potential suppliers of
such countermeasure, and whether other potential suppliers of the same or similar
countermeasures were considered and rejected for procurement under this section
and the reasons therefor.
(D) Subsequent specific countermeasures
Procurement under this subsection of a security countermeasure for a particular purpose does not preclude the subsequent procurement under this subsection of any other
security countermeasure for such purpose if
the Secretary has determined under paragraph (5)(A) that such countermeasure is appropriate for inclusion in the stockpile and
if, as determined by the Secretary, such
countermeasure provides improved safety or
effectiveness, or for other reasons enhances
preparedness to respond to threats of use of
a biological, chemical, radiological, or nuclear agent. Such a determination by the
Secretary is committed to agency discretion.
(E) Rule of construction
Recommendations and approvals under
this paragraph apply solely to determinations that the special reserve fund under
paragraph (10) will be made available for a
procurement of a security countermeasure,
and not to the substance of contracts for
such procurement or other matters relating
to awards of such contracts.
(7) Procurement
(A) In general
For purposes of a procurement under this
subsection that is approved by the President
under paragraph (6), the Homeland Security
Secretary and the Secretary shall have responsibilities in accordance with subparagraphs (B) and (C).
(B) Interagency agreement; cost
The Homeland Security Secretary shall
enter into an agreement with the Secretary
for procurement of a security countermeasure in accordance with the provisions
of this paragraph. The special reserve fund
under paragraph (10) shall be available for
payments made by the Secretary to a vendor
for such procurement.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) Procurement
(i) In general
The Secretary shall be responsible for—
(I) arranging for procurement of a security countermeasure, including negotiating terms (including quantity, production schedule, and price) of, and entering into, contracts and cooperative
agreements, and for carrying out such
other activities as may reasonably be required, in accordance with the provisions
of this subparagraph; and
(II) promulgating such regulations as
the Secretary determines necessary to
implement the provisions of this subsection.
(ii) Contract terms
A contract for procurements under this
subsection shall (or, as specified below,
may) include the following terms:
(I) Payment conditioned on delivery
The contract shall provide that no payment may be made until delivery of a
portion, acceptable to the Secretary, of
the total number of units contracted for,
except that, notwithstanding any other
provision of law, the contract may provide that, if the Secretary determines (in
the Secretary’s discretion) that an advance payment, partial payment for significant milestones, or payment to increase manufacturing capacity is necessary to ensure success of a project, the
Secretary shall pay an amount, not to
exceed 10 percent of the contract
amount, in advance of delivery. The Secretary shall, to the extent practicable,
make the determination of advance payment at the same time as the issuance of
a solicitation. The contract shall provide
that such advance payment is required
to be repaid if there is a failure to perform by the vendor under the contract.
The contract may also provide for additional advance payments of 5 percent
each for meeting the milestones specified in such contract, except that such
payments shall not exceed 50 percent of
the total contract amount. If the specified milestones are reached, the advanced payments of 5 percent shall not
be required to be repaid. Nothing in this
subclause shall be construed as affecting
the rights of vendors under provisions of
law or regulation (including the Federal
Acquisition Regulation) relating to the
termination of contracts for the convenience of the Government.
(II) Discounted payment
The contract may provide for a discounted price per unit of a product that
is not licensed, cleared, or approved as
described in paragraph (1)(B)(i)(III)(aa)
at the time of delivery, and may provide
for payment of an additional amount per
unit if the product becomes so licensed,
cleared, or approved before the expiration date of the contract (including an

§ 247d–6b

additional amount per unit of product
delivered before the effective date of
such licensing, clearance, or approval).
(III) Contract duration
The contract shall be for a period not
to exceed five years, except that, in first
awarding the contract, the Secretary
may provide for a longer duration, not
exceeding eight years, if the Secretary
determines that complexities or other
difficulties in performance under the
contract justify such a period. The contract shall be renewable for additional
periods, none of which shall exceed five
years.
(IV) Storage by vendor
The contract may provide that the
vendor will provide storage for stocks of
a product delivered to the ownership of
the Federal Government under the contract, for such period and under such
terms and conditions as the Secretary
may specify, and in such case amounts
from the special reserve fund under paragraph (10) shall be available for costs of
shipping, handling, storage, and related
costs for such product.
(V) Product approval
The contract shall provide that the
vendor seek approval, clearance, or licensing of the product from the Secretary; for a timetable for the development of data and other information to
support such approval, clearance, or licensing; and that the Secretary may
waive part or all of this contract term on
request of the vendor or on the initiative
of the Secretary.
(VI) Non-stockpile transfers of security
countermeasures
The contract shall provide that the
vendor will comply with all applicable
export-related controls with respect to
such countermeasure.
(VII) Sales exclusivity
The contract may provide that the
vendor is the exclusive supplier of the
product to the Federal Government for a
specified period of time, not to exceed
the term of the contract, on the condition that the vendor is able to satisfy
the needs of the Government. During the
agreed period of sales exclusivity, the
vendor shall not assign its rights of sales
exclusivity to another entity or entities
without approval by the Secretary. Such
a sales exclusivity provision in such a
contract shall constitute a valid basis
for a sole source procurement under section 3304(a)(1) of title 41.
(VIII) Warm based surge capacity
The contract may provide that the
vendor establish domestic manufacturing capacity of the product to ensure
that additional production of the product is available in the event that the
Secretary determines that there is a

§ 247d–6b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

need to quickly purchase additional
quantities of the product. Such contract
may provide a fee to the vendor for establishing and maintaining such capacity in excess of the initial requirement
for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be
an allowable and allocable direct cost of
the contract.
(IX) Contract terms
The Secretary, in any contract for procurement under this section, may specify—
(aa) the dosing and administration
requirements for countermeasures to
be developed and procured;
(bb) the amount of funding that will
be dedicated by the Secretary for development and acquisition of the countermeasure; and
(cc) the specifications the countermeasure must meet to qualify for procurement under a contract under this
section.
(iii) Availability of simplified acquisition
procedures
(I) In general
If the Secretary determines that there
is a pressing need for a procurement of a
specific countermeasure, the amount of
the procurement under this subsection
shall be deemed to be below the threshold amount specified in section 134 of
title 41, for purposes of application to
such procurement, pursuant to section
3101(b)(1)(A) of title 41, of—
(aa) section 3305(a)(1) of title 41 and
its implementing regulations; and
(bb) section 3101(b)(1)(B) of title 41
and its implementing regulations.
(II) Application of certain provisions
Notwithstanding subclause (I) and the
provision of law and regulations referred
to in such clause, each of the following
provisions shall apply to procurements
described in this clause to the same extent that such provisions would apply to
such procurements in the absence of subclause (I):
(aa) Chapter 37 of title 40 (relating to
contract work hours and safety standards).
(bb) Section 8703(a) of title 41.
(cc) Section 4706 of title 41 (relating
to the examination of contractor
records).
(dd) Section 3131 of title 40 (relating
to bonds of contractors of public buildings or works).
(ee) Section 3901 of title 41 (relating
to contingent fees to middlemen).
(ff) Section 6962 of this title.
(gg) Section 1354 of title 31 (relating
to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment
reporting requirements).

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(III) Internal controls to be established
The Secretary shall establish appropriate internal controls for procurements made under this clause, including
requirements with respect to documentation of the justification for the use
of the authority provided under this
paragraph with respect to the procurement involved.
(IV) Authority to limit competition
In conducting a procurement under
this subparagraph, the Secretary may
not use the authority provided for under
subclause (I) to conduct a procurement
on a basis other than full and open competition unless the Secretary determines
that the mission of the BioShield Program under the Project BioShield Act of
2004 would be seriously impaired without
such a limitation.
(iv) Procedures other than full and open
competition
(I) In general
In using the authority provided in section 3304(a)(1) of title 41 to use procedures other than competitive procedures
in the case of a procurement under this
subsection, the phrase ‘‘available from
only one responsible source’’ in such section 3304(a)(1) shall be deemed to mean
‘‘available from only one responsible
source or only from a limited number of
responsible sources’’.
(II) Relation to other authorities
The authority under subclause (I) is in
addition to any other authority to use
procedures other than competitive procedures.
(III) Applicable government-wide regulations
The Secretary shall implement this
clause in accordance with governmentwide regulations implementing such section 3304(a)(1) (including requirements
that offers be solicited from as many potential sources as is practicable under
the circumstances, that required notices
be published, and that submitted offers
be considered), as such regulations apply
to procurements for which an agency has
authority to use procedures other than
competitive procedures when the property or services needed by the agency are
available from only one responsible
source or only from a limited number of
responsible sources and no other type of
property or services will satisfy the
needs of the agency.
(v) Premium provision in multiple award
contracts
(I) In general
If, under this subsection, the Secretary
enters into contracts with more than one
vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in each of such contracts a provision that—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(aa) identifies an increment of the
total quantity of security countermeasure required, whether by percentage or by numbers of units; and
(bb) promises to pay one or more
specified premiums based on the priority of such vendors’ production and delivery of the increment identified
under item (aa), in accordance with
the terms and conditions of the contract.
(II) Determination of Government’s requirement not reviewable
If the Secretary includes in each of a
set of contracts a provision as described
in subclause (I), such Secretary’s determination of the total quantity of security countermeasure required, and any
amendment of such determination, is
committed to agency discretion.
(vi) Extension of closing date for receipt of
proposals not reviewable
A decision by the Secretary to extend
the closing date for receipt of proposals for
a procurement under this subsection is
committed to agency discretion.
(vii) Limiting competition to sources responding to request for information
In conducting a procurement under this
subsection, the Secretary may exclude a
source that has not responded to a request
for information under section 3306(a)(1)(B)
of title 41 if such request has given notice
that the Secretary may so exclude such a
source.
(8) Interagency cooperation
(A) In general
In carrying out activities under this section, the Homeland Security Secretary and
the Secretary are authorized, subject to subparagraph (B), to enter into interagency
agreements and other collaborative undertakings with other agencies of the United
States Government. Such agreements may
allow other executive agencies to order
qualified and security countermeasures
under procurement contracts or other agreements established by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as
reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31, except that
all such orders shall be processed under the
terms established under this subsection for
the procurement of countermeasures.
(B) Limitation
An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the authorities provided by
this section to the Homeland Security Secretary or to the Secretary.
(9) Restrictions on use of funds
Amounts in the special reserve fund under
paragraph (10) shall not be used to pay—
(A) costs for the purchase of vaccines
under procurement contracts entered into
before July 21, 2004; or

§ 247d–6b

(B) costs other than payments made by the
Secretary to a vendor for a procurement of a
security countermeasure under paragraph
(7).
(10) Definitions
(A) Special reserve fund
For purposes of this subsection, the term
‘‘special reserve fund’’ has the meaning
given such term in section 510 1 of the Homeland Security Act of 2002.
(B) Designated congressional committees
For purposes of this section, the term
‘‘designated
congressional
committees’’
means the following committees of the Congress:
(i) In the House of Representatives: the
Committee on Energy and Commerce, the
Committee on Appropriations, the Committee on Government Reform, and the
Select Committee on Homeland Security
(or any successor to the Select Committee).
(ii) In the Senate: the appropriate committees.
(d) Disclosures
No Federal agency shall disclose under section
552 of title 5 any information identifying the location at which materials in the stockpile under
subsection (a) of this section are stored.
(e) Definition
For purposes of subsection (a) of this section,
the term ‘‘stockpile’’ includes—
(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a) of this section; or
(2) a contractual agreement between the
Secretary and a vendor or vendors under
which such vendor or vendors agree to provide
to such Secretary supplies described in subsection (a) of this section.
(f) Authorization of appropriations
(1) Strategic National Stockpile
For the purpose of carrying out subsection
(a) of this section, there are authorized to be
appropriated $640,000,000 for fiscal year 2002,
and such sums as may be necessary for each of
fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special
reserve fund referred to in subsection (c)(10)(A)
of this section.
(2) Smallpox vaccine development
For the purpose of carrying out subsection
(b) of this section, there are authorized to be
appropriated $509,000,000 for fiscal year 2002,
and such sums as may be necessary for each of
fiscal years 2003 through 2006.
(July 1, 1944, ch. 373, title III, § 319F–2, formerly
Pub. L. 107–188, title I, § 121, June 12, 2002, 116
Stat. 611; Pub. L. 107–296, title XVII, § 1705(a),
Nov. 25, 2002, 116 Stat. 2316; renumbered § 319F–2
of act July 1, 1944, and amended Pub. L. 108–276,
§ 3(a), July 21, 2004, 118 Stat. 842; Pub. L. 109–417,
title I, § 102(c), title IV, §§ 403(b), 406, Dec. 19,
2006, 120 Stat. 2834, 2874, 2879.)
1 See

References in Text note below.

§ 247d–6b

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(1)(B)(i)(III)(aa), is act June 25, 1938, ch.
675, 52 Stat. 1040, as amended. Chapter V of the Act is
classified generally to subchapter V (§ 351 et seq.) of
chapter 9 of Title 21, Food and Drugs. For complete
classification of this Act to the Code, see section 301 of
Title 21 and Tables.
The Project BioShield Act of 2004, referred to in subsec. (c)(7)(C)(iii)(IV), is Pub. L. 108–276, July 21, 2004, 118
Stat. 835. For complete classification of this Act to the
Code, see Short Title of 2004 Amendments note set out
under section 201 of this title and Tables.
Section 510 of the Homeland Security Act of 2002, referred to in subsec. (c)(10)(A), probably means section
510 of Pub. L. 107–296 as added by Pub. L. 108–276, which
defines ‘‘special reserve fund’’, and which was renumbered section 521 of that Act by Pub. L. 109–295, title VI,
§ 611(7), Oct. 4, 2006, 120 Stat. 1395, and is classified to
section 321j of Title 6, Domestic Security. Another section 510 of Pub. L. 107–296, relating to urban and other
high risk area communications capabilities, was classified to section 321 of Title 6, prior to repeal by Pub. L.
109–295, title VI, § 611(5), Oct. 4, 2006, 120 Stat. 1395. Another section 510 of Pub. L. 107–296, relating to credentialing and typing, is classified to section 320 of
Title 6.
CODIFICATION
In subsec. (c)(7)(C)(ii)(VII), ‘‘section 3304(a)(1) of title
41’’ substituted for ‘‘section 303(c)(1) of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 253(c)(1))’’ on authority of Pub. L. 111–350, § 6(c),
Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41,
Public Contracts.
In subsec. (c)(7)(C)(iii)(I), ‘‘section 134 of title 41’’ substituted for ‘‘section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11))’’ and ‘‘section
3101(b)(1)(A) of title 41’’ substituted for ‘‘section 302A(a)
of the Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 252a(a))’’ on authority of Pub. L.
111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(7)(C)(iii)(I)(aa), ‘‘section 3305(a)(1) of
title 41’’ substituted for ‘‘section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949
(41 U.S.C. 253(g)(1)(A))’’ on authority of Pub. L. 111–350,
§ 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted
Title 41, Public Contracts.
In subsec. (c)(7)(C)(iii)(I)(bb), ‘‘section 3101(b)(1)(B) of
title 41’’ substituted for ‘‘section 302A(b) of such Act (41
U.S.C. 252a(b))’’ on authority of Pub. L. 111–350, § 6(c),
Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41,
Public Contracts.
In subsec. (c)(7)(C)(iii)(II)(bb), ‘‘Section 8703(a) of title
41’’ substituted for ‘‘Subsections (a) and (b) of section
7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and
(b))’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011,
124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(7)(C)(iii)(II)(cc), ‘‘Section 4706 of title
41’’ substituted for ‘‘Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
254d)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011,
124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(7)(C)(iii)(II)(ee), ‘‘Section 3901 of title
41’’ substituted for ‘‘Subsection (a) of section 304 of the
Federal Property and Administrative Services Act of
1949 (41 U.S.C. 254(a))’’ on authority of Pub. L. 111–350,
§ 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted
Title 41, Public Contracts.
In subsec. (c)(7)(C)(iv)(I), ‘‘section 3304(a)(1) of title
41’’ substituted for ‘‘section 303(c)(1) of title III of the
Federal Property and Administrative Services Act of
1949 (41 U.S.C. 253(c)(1))’’ and ‘‘such section 3304(a)(1)’’
substituted for ‘‘such section 303(c)(1)’’ on authority of
Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which
Act enacted Title 41, Public Contracts.

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In subsec. (c)(7)(C)(iv)(III), ‘‘such section 3304(a)(1)’’
substituted for ‘‘such section 303(c)(1)’’ on authority of
Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which
Act enacted Title 41, Public Contracts.
In subsec. (c)(7)(C)(vii), ‘‘section 3306(a)(1)(B) of title
41’’ substituted for ‘‘section 303A(a)(1)(B) of the Federal
Property and Administrative Services Act of 1949 (41
U.S.C. 253a(a)(1)(B))’’ on authority of Pub. L. 111–350,
§ 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted
Title 41, Public Contracts.
Section was formerly classified to section 300hh–12 of
this title prior to renumbering by Pub. L. 108–276.
AMENDMENTS
2006—Pub. L. 109–417, § 406(1), inserted ‘‘and security
countermeasure procurements’’ after ‘‘Stockpile’’ in
section catchline.
Subsec. (a)(1). Pub. L. 109–417, § 102(c), inserted ‘‘in
collaboration with the Director of the Centers for Disease Control and Prevention, and’’ after ‘‘The Secretary,’’ and inserted at end ‘‘The Secretary shall conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including
non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review.’’
Subsec. (c). Pub. L. 109–417, § 406(2)(A), struck out
‘‘biomedical’’ before ‘‘countermeasures’’ in heading.
Subsec. (c)(1)(B)(i)(I). Pub. L. 109–417, § 403(b), which
directed amendment of section 319F–2(c)(1)(B) by substituting ‘‘diagnose, mitigate, prevent, or treat’’ for
‘‘treat, identify, or prevent’’ wherever appearing, was
executed by making the substitution in two places in
subsec. (c)(1)(B)(i)(I) of this section, which is section
319F–2 of the Public Health Service Act, to reflect the
probable intent of Congress.
Subsec. (c)(3). Pub. L. 109–417, § 406(2)(B), designated
existing provisions as subpar. (A), inserted heading, and
added subpar. (B).
Subsec. (c)(4)(A). Pub. L. 109–417, § 406(2)(C), inserted
‘‘not developed or’’ after ‘‘currently’’ in introductory
provisions.
Subsec. (c)(5)(B)(i). Pub. L. 109–417, § 406(2)(D), substituted ‘‘to meet the stockpile needs’’ for ‘‘to meet the
needs of the stockpile’’.
Subsec. (c)(7)(B). Pub. L. 109–417, § 406(2)(E), substituted ‘‘cost’’ for ‘‘costs’’ in subpar. heading, struck
out cl. (i) designation and heading before ‘‘The Homeland’’, and struck out heading and text of cl. (ii). Text
read as follows: ‘‘The actual costs to the Secretary
under this section, other than the costs described in
clause (i), shall be paid from the appropriation provided
for under subsection (f)(1) of this section.’’
Subsec. (c)(7)(C)(ii)(I). Pub. L. 109–417, § 406(2)(F)(i),
amended heading and text of subcl. (I) generally. Prior
to amendment, text read as follows: ‘‘The contract
shall provide that no payment may be made until delivery has been made of a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding any other provision of law,
the contract may provide that, if the Secretary determines (in the Secretary’s discretion) that an advance
payment is necessary to ensure success of a project, the
Secretary may pay an amount, not to exceed 10 percent
of the contract amount, in advance of delivery. The
contract shall provide that such advance payment is required to be repaid if there is a failure to perform by
the vendor under the contract. Nothing in this subclause may be construed as affecting rights of vendors
under provisions of law or regulation (including the
Federal Acquisition Regulation) relating to termination of contracts for the convenience of the Government.’’
Subsec. (c)(7)(C)(ii)(VII) to (IX). Pub. L. 109–417,
§ 406(2)(F)(ii), added subcls. (VII) to (IX).
Subsec. (c)(8)(A). Pub. L. 109–417, § 406(2)(G), inserted
at end ‘‘Such agreements may allow other executive
agencies to order qualified and security countermeasures under procurement contracts or other agreements established by the Secretary. Such ordering

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process (including transfers of appropriated funds between an agency and the Department of Health and
Human Services as reimbursements for such orders for
countermeasures) may be conducted under the authority of section 1535 of title 31, except that all such orders
shall be processed under the terms established under
this subsection for the procurement of countermeasures.’’
2004—Pub. L. 108–276, § 3(a)(2), amended section generally. Prior to amendment, text related in subsec. (a) to
Strategic National Stockpile, in subsec. (b) to smallpox
vaccine development, in subsec. (c) to disclosures, in
subsec. (d) to definition of ‘‘stockpile’’, and in subsec.
(e) to authorization of appropriations.
2002—Subsec. (a)(1). Pub. L. 107–296, § 1705(a)(1), substituted ‘‘The Secretary of Homeland Security’’ for
‘‘The Secretary of Health and Human Services’’ and inserted ‘‘the Secretary of Health and Human Services
and’’ after ‘‘in coordination with’’ and ‘‘of Health and
Human Services’’ after ‘‘as are determined by the Secretary’’.
Subsecs. (a)(2), (b)(1). Pub. L. 107–296, § 1705(a)(2), inserted ‘‘of Health and Human Services’’ after ‘‘Secretary’’ wherever appearing.
CHANGE OF NAME
Committee on Government Reform of House of Representatives changed to Committee on Oversight and
Government Reform of House of Representatives by
House Resolution No. 6, One Hundred Tenth Congress,
Jan. 5, 2007.
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107–296, title XVII, § 1705(b), Nov. 25, 2002, 116
Stat. 2316, provided that: ‘‘The amendments made by
this section [amending this section] shall take effect on
the date of transfer of the Strategic National Stockpile
of the Department of Health and Human Services to
the Department [of Homeland Security].’’
STOCKPILE FUNCTIONS TRANSFERRED
Pub. L. 108–276, § 3(c)(1),(2), July 21, 2004, 118 Stat. 853,
provided that:
‘‘(1) IN GENERAL.—Except as provided in paragraph (2),
there shall be transferred to the Secretary of Health
and Human Services the functions, personnel, assets,
unexpended balances, and liabilities of the Strategic
National Stockpile, including the functions of the Secretary of Homeland Security relating thereto.
‘‘(2) EXCEPTIONS.—
‘‘(A) FUNCTIONS.—The transfer of functions pursuant to paragraph (1) shall not include such functions
as are explicitly assigned to the Secretary of Homeland Security by this Act [see Short Title of 2004
Amendments note set out under section 201 of this
title] (including the amendments made by this Act).
‘‘(B) ASSETS AND UNEXPENDED BALANCES.—The
transfer of assets and unexpended balances pursuant
to paragraph (1) shall not include the funds appropriated under the heading ‘BIODEFENSE COUNTERMEASURES’ in the Department of Homeland Security
Appropriations Act, 2004 (Public Law 108–90 [117 Stat.
1148]).’’
POTASSIUM IODIDE
Pub. L. 107–188, title I, § 127, June 12, 2002, 116 Stat.
615, provided that:
‘‘(a) IN GENERAL.—Through the national stockpile
under section 121 [now section 319F–2 of act July 1, 1944,
this section], the President, subject to subsections (b)
and (c), shall make available to State and local governments potassium iodide tablets for stockpiling and for
distribution as appropriate to public facilities, such as
schools and hospitals, in quantities sufficient to provide adequate protection for the population within 20
miles of a nuclear power plant.
‘‘(b) STATE AND LOCAL PLANS.—
‘‘(1) IN GENERAL.—Subsection (a) applies with respect to a State or local government, subject to para-

§ 247d–6b

graph (2), if the government involved meets the following conditions:
‘‘(A) Such government submits to the President a
plan for the stockpiling of potassium iodide tablets,
and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident.
‘‘(B) The plan is accompanied by certifications by
such government that the government has not already received sufficient quantities of potassium
iodide tablets from the Federal Government.
‘‘(2) LOCAL GOVERNMENTS.—Subsection (a) applies
with respect to a local government only if, in addition to the conditions described in paragraph (1), the
following conditions are met:
‘‘(A) The State in which the locality involved is
located—
‘‘(i) does not have a plan described in paragraph
(1)(A); or
‘‘(ii) has a plan described in such paragraph, but
the plan does not address populations at a distance greater than 10 miles from the nuclear
power plant involved.
‘‘(B) The local government has petitioned the
State to modify the State plan to address such populations, not exceeding 20 miles from such plant,
and 60 days have elapsed without the State modifying the State plan to address populations at the full
distance sought by the local government through
the petition.
‘‘(C) The local government has submitted its local
plan under paragraph (1)(A) to the State, and the
State has approved the plan and certified that the
plan is not inconsistent with the State emergency
plan.
‘‘(c) GUIDELINES.—Not later than one year after the
date of the enactment of this Act [June 12, 2002], the
President, in consultation with individuals representing appropriate Federal, State, and local agencies,
shall establish guidelines for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident. Such tablets may not be made available
under subsection (a) until such guidelines have been established.
‘‘(d) INFORMATION.—The President shall carry out activities to inform State and local governments of the
program under this section.
‘‘(e) REPORTS.—
‘‘(1) PRESIDENT.—Not later than six months after
the date on which the guidelines under subsection (c)
are issued, the President shall submit to the Congress
a report—
‘‘(A) on whether potassium iodide tablets have
been made available under subsection (a) or other
Federal, State, or local programs, and the extent to
which State and local governments have established stockpiles of such tablets; and
‘‘(B) the measures taken by the President to implement this section.
‘‘(2) NATIONAL ACADEMY OF SCIENCES.—
‘‘(A) IN GENERAL.—The President shall request the
National Academy of Sciences to enter into an
agreement with the President under which the
Academy conducts a study to determine what is the
most effective and safe way to distribute and administer potassium iodide tablets on a mass scale.
If the Academy declines to conduct the study, the
President shall enter into an agreement with another appropriate public or nonprofit private entity
to conduct the study.
‘‘(B) REPORT.—The President shall ensure that,
not later than six months after the date of the enactment of this Act [June 12, 2002], the study required in subparagraph (A) is completed and a report describing the findings made in the study is
submitted to the Congress.
‘‘(f) APPLICABILITY.—Subsections (a) and (d) cease to
apply as requirements if the President determines that
there is an alternative and more effective prophylaxis

§ 247d–6c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or preventive measures for adverse thyroid conditions
that may result from the release of radionuclides from
nuclear power plants.’’
[Memorandum of President of the United States, July
3, 2007, 72 F.R. 37627, provided:
[Memorandum for the Secretary of Health and
Human Services[,] the Secretary of Energy[,] the Secretary of Homeland Security[,] the Chairman of the Nuclear Regulatory Commission[, and] the Director of the
Office of Science and Technology Policy
[By the authority vested in me as President by the
Constitution and the laws of the United States, including section 301 of title 3, United States Code, and section 204(b) of the National Science and Technology Policy, Organization, and Priorities Act of 1976, as amended (42 U.S.C. 6613(b)), the functions of the President
under section 127 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
(Public Law 107–188) (42 U.S.C. 247d–6b note) are assigned as follows:
[(1) the function of making a determination under
subsection 127(f) of Public Law 107–188 is assigned to
the Director of the Office of Science and Technology
Policy; and
[(2) the functions of the President under section 127 of
Public Law 107–188 other than that assigned under subsection 127(f) are assigned to the Chairman of the Nuclear Regulatory Commission.
[In the performance of such functions the Chairman
and the Director should consult each other and the Secretaries of Health and Human Services, Energy, and
Homeland Security, as appropriate.
[The Director is authorized and directed to publish
this memorandum in the Federal Register.]
DESIGNATION AND AUTHORIZATION TO PERFORM FUNCTIONS UNDER SECTION 319F–2 OF THE PUBLIC HEALTH
SERVICE ACT
Memorandum of President of the United States, Oct.
21, 2004, 69 F.R. 70349, provided:
Memorandum for the Director of the Office of Management and Budget
By the authority vested in me by the Constitution
and the laws of the United States of America, including
section 301 of title 3, United States Code, I hereby direct you to perform the functions vested in the President under section 319F–2(c)(6) of the Public Health
Service Act, 42 U.S.C. 247d–6b(c)(6).
Any reference in this memorandum to the provision
of any Act shall be deemed to include references to any
hereafter-enacted provision of law that is the same or
substantially the same as such provision.
You are authorized and directed to publish this
memorandum in the Federal Register.
GEORGE W. BUSH.

§ 247d–6c. Reports regarding authorities under
this Act
(a) Secretary of Health and Human Services
(1) Annual reports on particular exercises of
authority
(A) Relevant authorities
The Secretary of Health and Human Services (referred to in this subsection as the
‘‘Secretary’’) shall submit reports in accordance with subparagraph (B) regarding the
exercise of authority under the following
provisions of law:
(i) With respect to section 247d–6a of this
title:
(I) Subsection (b)(1) (relating to increased simplified acquisition threshold).
(II) Subsection (b)(2) (relating to procedures other than full and open competition).

Page 224

(III) Subsection (c) (relating to expedited peer review procedures).
(ii) With respect to section 247d–6b of
this title:
(I) Subsection (c)(7)(C)(iii) (relating to
simplified acquisition procedures).
(II) Subsection (c)(7)(C)(iv) (relating to
procedures other than full and open competition).
(III) Subsection (c)(7)(C)(v) (relating to
premium provision in multiple-award
contracts).
(iii) With respect to section 360bbb–3 of
title 21:
(I) Subsection (a)(1) (relating to emergency uses of certain drugs and devices).
(II) Subsection (b)(1) (relating to a declaration of an emergency).
(III) Subsection (e) (relating to conditions on authorization).
(B) Contents of reports
The Secretary shall annually submit to
the designated congressional committees a
report that summarizes—
(i) the particular actions that were
taken under the authorities specified in
subparagraph (A), including, as applicable,
the identification of the threat agent,
emergency, or the biomedical countermeasure with respect to which the authority was used;
(ii) the reasons underlying the decision
to use such authorities, including, as applicable, the options that were considered
and rejected with respect to the use of
such authorities;
(iii) the number of, nature of, and other
information concerning the persons and
entities that received a grant, cooperative
agreement, or contract pursuant to the use
of such authorities, and the persons and
entities that were considered and rejected
for such a grant, cooperative agreement,
or contract, except that the report need
not disclose the identity of any such person or entity; and
(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this
title, a contract was entered into within
one year after such approval by the President.
(2) Annual summaries regarding certain activity
The Secretary shall annually submit to the
designated congressional committees a report
that summarizes the activity undertaken pursuant to the following authorities under section 247d–6a of this title:
(A) Subsection (b)(3) (relating to increased
micropurchase threshold).
(B) Subsection (d) (relating to authority
for personal services contracts).
(C) Subsection (e) (relating to streamlined
personnel authority).
With respect to subparagraph (B), the report
shall include a provision specifying, for the
one-year period for which the report is submit-

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ted, the number of persons who were paid
amounts greater than $100,000 and the number
of persons who were paid amounts between
$50,000 and $100,000.
(3) Report on additional barriers to procurement of security countermeasures
Not later than one year after July 21, 2004,
the Secretary, in consultation with the Secretary of Homeland Security, shall report to
the designated congressional committees any
potential barriers to the procurement of security countermeasures that have not been addressed by this Act.
(b) Government Accountability Office review
(1) In general
Four years after July 21, 2004, the Comptroller General of the United States shall initiate
a study—
(A)(i) to review the Secretary of Health
and Human Services’ utilization of the authorities granted under this Act with respect
to simplified acquisition procedures, procedures other than full and open competition,
increased micropurchase thresholds, personal services contracts, streamlined personnel authority, and the purchase of security
countermeasures under the special reserve
fund; and
(ii) to make recommendations to improve
the utilization or effectiveness of such authorities in the future;
(B)(i) to review and assess the adequacy of
the internal controls instituted by such Secretary with respect to such authorities,
where required by this Act; and
(ii) to make recommendations to improve
the effectiveness of such controls;
(C)(i) to review such Secretary’s utilization of the authority granted under this Act
to authorize an emergency use of a biomedical countermeasure, including the
means by which the Secretary determines
whether and under what conditions any such
authorizations should be granted and the
benefits and adverse impacts, if any, resulting from the use of such authority; and
(ii) to make recommendations to improve
the utilization or effectiveness of such authority and to enhance protection of the
public health;
(D) to identify any purchases or procurements that would not have been made or
would have been significantly delayed except
for the authorities described in subparagraph (A)(i); and
(E)(i) to determine whether and to what
extent activities undertaken pursuant to the
biomedical countermeasure research and development authorities established in this
Act have enhanced the development of biomedical countermeasures affecting national
security; and
(ii) to make recommendations to improve
the ability of the Secretary to carry out
these activities in the future.
(2) Additional provisions regarding determination on development of biomedical countermeasures affecting national security
In the report under paragraph (1), the determination under subparagraph (E) of such paragraph shall include—

§ 247d–6c

(A) the Comptroller General’s assessment
of the current availability of countermeasures to address threats identified by
the Secretary of Homeland Security;
(B) the Comptroller General’s assessment
of the extent to which programs and activities under this Act will reduce any gap between the threat and the availability of
countermeasures to an acceptable level of
risk; and
(C)(i) the Comptroller General’s assessment of threats to national security that are
posed by technology that will enable, during
the 10-year period beginning on July 21, 2004,
the development of antibiotic resistant, mutated, or bioengineered strains of biological
agents; and
(ii) recommendations on short-term and
long-term governmental strategies for addressing such threats, including recommendations for Federal policies regarding
research priorities, the development of countermeasures, and investments in technology.
(3) Report
A report providing the results of the study
under paragraph (1) shall be submitted to the
designated congressional committees not later
than five years after July 21, 2004.
(c) Report regarding biocontainment facilities
Not later than 120 days after July 21, 2004, the
Secretary of Homeland Security and the Secretary of Health and Human Services shall
jointly report to the designated congressional
committees whether there is a lack of adequate
large-scale biocontainment facilities necessary
for the testing of security countermeasures in
accordance with Food and Drug Administration
requirements.
(d) Designated congressional committees
For purposes of this section, the term ‘‘designated congressional committees’’ means the
following committees of the Congress:
(1) In the House of Representatives: the
Committee on Energy and Commerce, the
Committee on Appropriations, the Committee
on Government Reform, and the Select Committee on Homeland Security (or any successor to the Select Committee).
(2) In the Senate: the appropriate committees.
(Pub. L. 108–276, § 5, July 21, 2004, 118 Stat. 860.)
REFERENCES IN TEXT
This Act, referred to in subsecs. (a)(3) and (b)(1),
(2)(B), is Pub. L. 108–276, July 21, 2004, 118 Stat. 835,
known as the Project BioShield Act of 2004. For complete classification of this Act to the Code, see Short
Title of 2004 Amendments note set out under section 201
of this title and Tables.
CODIFICATION
Section was enacted as part of the Project BioShield
Act of 2004, and not as part of the Public Health Service
Act which comprises this chapter.
CHANGE OF NAME
Committee on Government Reform of House of Representatives changed to Committee on Oversight and
Government Reform of House of Representatives by
House Resolution No. 6, One Hundred Tenth Congress,
Jan. 5, 2007.

§ 247d–6d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 247d–6d. Targeted liability protections for pandemic and epidemic products and security
countermeasures
(a) Liability protections
(1) In general
Subject to the other provisions of this section, a covered person shall be immune from
suit and liability under Federal and State law
with respect to all claims for loss caused by,
arising out of, relating to, or resulting from
the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) of this section has
been issued with respect to such countermeasure.
(2) Scope of claims for loss
(A) Loss
For purposes of this section, the term
‘‘loss’’ means any type of loss, including—
(i) death;
(ii) physical, mental, or emotional injury, illness, disability, or condition;
(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.
Each of clauses (i) through (iv) applies without regard to the date of the occurrence,
presentation, or discovery of the loss described in the clause.
(B) Scope
The immunity under paragraph (1) applies
to any claim for loss that has a causal relationship with the administration to or use
by an individual of a covered countermeasure, including a causal relationship
with the design, development, clinical testing or investigation, manufacture, labeling,
distribution, formulation, packaging, marketing, promotion, sale, purchase, donation,
dispensing, prescribing, administration, licensing, or use of such countermeasure.
(3) Certain conditions
Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies
only if—
(A) the countermeasure was administered
or used during the effective period of the
declaration that was issued under subsection
(b) of this section with respect to the countermeasure;
(B) the countermeasure was administered
or used for the category or categories of diseases, health conditions, or threats to health
specified in the declaration; and
(C) in addition, in the case of a covered
person who is a program planner or qualified
person with respect to the administration or
use of the countermeasure, the countermeasure was administered to or used by an
individual who—
(i) was in a population specified by the
declaration; and
(ii) was at the time of administration
physically present in a geographic area

Page 226

specified by the declaration or had a connection to such area specified in the declaration.
(4) Applicability of certain conditions
With respect to immunity under paragraph
(1) and subject to the other provisions of this
section:
(A) In the case of a covered person who is
a manufacturer or distributor of the covered
countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by
an individual in accordance with the conditions described in paragraph (3)(C).
(B) In the case of a covered person who is
a program planner or qualified person with
respect to the administration or use of the
covered countermeasure, the scope of immunity includes circumstances in which the
countermeasure was administered to or used
by an individual in circumstances in which
the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in paragraph (3)(C).
(5) Effect of distribution method
The provisions of this section apply to a covered countermeasure regardless of whether
such countermeasure is obtained by donation,
commercial sale, or any other means of distribution, except to the extent that, under
paragraph (2)(E) of subsection (b) of this section, the declaration under such subsection
provides that subsection (a) of this section applies only to covered countermeasures obtained through a particular means of distribution.
(6) Rebuttable presumption
For purposes of paragraph (1), there shall be
a rebuttable presumption that any administration or use, during the effective period of
the emergency declaration by the Secretary
under subsection (b) of this section, of a covered countermeasure shall have been for the
category or categories of diseases, health conditions, or threats to health with respect to
which such declaration was issued.
(b) Declaration by Secretary
(1) Authority to issue declaration
Subject to paragraph (2), if the Secretary
makes a determination that a disease or other
health condition or other threat to health constitutes a public health emergency, or that
there is a credible risk that the disease, condition, or threat may in the future constitute
such an emergency, the Secretary may make a
declaration, through publication in the Federal Register, recommending, under conditions
as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more covered
countermeasures, and stating that subsection
(a) of this section is in effect with respect to
the activities so recommended.
(2) Contents
In issuing a declaration under paragraph (1),
the Secretary shall identify, for each covered
countermeasure specified in the declaration—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the category or categories of diseases,
health conditions, or threats to health for
which the Secretary recommends the administration or use of the countermeasure;
(B) the period or periods during which, including as modified by paragraph (3), subsection (a) of this section is in effect, which
period or periods may be designated by
dates, or by milestones or other description
of events, including factors specified in paragraph (6);
(C) the population or populations of individuals for which subsection (a) of this section is in effect with respect to the administration or use of the countermeasure (which
may be a specification that such subsection
applies without geographic limitation to all
individuals);
(D) the geographic area or areas for which
subsection (a) of this section is in effect with
respect to the administration or use of the
countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect
to individuals in the populations identified
under subparagraph (C), a specification, as
determined appropriate by the Secretary, of
whether the declaration applies only to individuals physically present in such areas or
whether in addition the declaration applies
to individuals who have a connection to such
areas, which connection is described in the
declaration; and
(E) whether subsection (a) of this section
is effective only to a particular means of distribution as provided in subsection (a)(5) of
this section for obtaining the countermeasure, and if so, the particular means to
which such subsection is effective.
(3) Effective period of declaration
(A) Flexibility of period
The Secretary may, in describing periods
under paragraph (2)(B), have different periods for different covered persons to address
different logistical, practical or other differences in responsibilities.
(B) Additional time to be specified
In each declaration under paragraph (1),
the Secretary, after consulting, to the extent the Secretary deems appropriate, with
the manufacturer of the covered countermeasure, shall also specify a date that is
after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
(i) a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return
of such product to the manufacturer; and
(ii) a reasonable period for covered persons to take such other actions as may be
appropriate to limit administration or use
of the covered countermeasure.
(C) Additional period for certain strategic
national stockpile countermeasures
With respect to a covered countermeasure
that is in the stockpile under section 247d–6b
of this title, if such countermeasure was the
subject of a declaration under paragraph (1)

§ 247d–6d

at the time that it was obtained for the
stockpile, the effective period of such declaration shall include a period when the
countermeasure is administered or used pursuant to a distribution or release from the
stockpile.
(4) Amendments to declaration
The Secretary may through publication in
the Federal Register amend any portion of a
declaration under paragraph (1). Such an
amendment shall not retroactively limit the
applicability of subsection (a) of this section
with respect to the administration or use of
the covered countermeasure involved.
(5) Certain disclosures
In publishing a declaration under paragraph
(1) in the Federal Register, the Secretary is
not required to disclose any matter described
in section 552(b) of title 5.
(6) Factors to be considered
In deciding whether and under what circumstances or conditions to issue a declaration
under paragraph (1) with respect to a covered
countermeasure, the Secretary shall consider
the desirability of encouraging the design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale,
purchase, donation, dispensing, prescribing,
administration, licensing, and use of such
countermeasure.
(7) Judicial review
No court of the United States, or of any
State, shall have subject matter jurisdiction
to review, whether by mandamus or otherwise,
any action by the Secretary under this subsection.
(8) Preemption of State law
During the effective period of a declaration
under subsection (b) of this section, or at any
time with respect to conduct undertaken in
accordance with such declaration, no State or
political subdivision of a State may establish,
enforce, or continue in effect with respect to a
covered countermeasure any provision of law
or legal requirement that—
(A) is different from, or is in conflict with,
any requirement applicable under this section; and
(B) relates to the design, development,
clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing,
dispensing, or administration by qualified
persons of the covered countermeasure, or to
any matter included in a requirement applicable to the covered countermeasure under
this section or any other provision of this
chapter, or under the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.].
(9) Report to Congress
Within 30 days after making a declaration
under paragraph (1), the Secretary shall submit to the appropriate committees of the Congress a report that provides an explanation of

§ 247d–6d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the reasons for issuing the declaration and the
reasons underlying the determinations of the
Secretary with respect to paragraph (2). Within 30 days after making an amendment under
paragraph (4), the Secretary shall submit to
such committees a report that provides the
reasons underlying the determination of the
Secretary to make the amendment.
(c) Definition of willful misconduct
(1) Definition
(A) In general
Except as the meaning of such term is further restricted pursuant to paragraph (2),
the term ‘‘willful misconduct’’ shall, for purposes of subsection (d) of this section, denote
an act or omission that is taken—
(i) intentionally to achieve a wrongful
purpose;
(ii) knowingly without legal or factual
justification; and
(iii) in disregard of a known or obvious
risk that is so great as to make it highly
probable that the harm will outweigh the
benefit.
(B) Rule of construction
The criterion stated in subparagraph (A)
shall be construed as establishing a standard
for liability that is more stringent than a
standard of negligence in any form or recklessness.
(2) Authority to promulgate regulatory definition
(A) In general
The Secretary, in consultation with the
Attorney General, shall promulgate regulations, which may be promulgated through
interim final rules, that further restrict the
scope of actions or omissions by a covered
person that may qualify as ‘‘willful misconduct’’ for purposes of subsection (d) of
this section.
(B) Factors to be considered
In promulgating the regulations under this
paragraph, the Secretary, in consultation
with the Attorney General, shall consider
the need to define the scope of permissible
civil actions under subsection (d) of this section in a way that will not adversely affect
the public health.
(C) Temporal scope of regulations
The regulations under this paragraph may
specify the temporal effect that they shall
be given for purposes of subsection (d) of this
section.
(D) Initial rulemaking
Within 180 days after December 30, 2005,
the Secretary, in consultation with the Attorney General, shall commence and complete an initial rulemaking process under
this paragraph.
(3) Proof of willful misconduct
In an action under subsection (d) of this section, the plaintiff shall have the burden of
proving by clear and convincing evidence willful misconduct by each covered person sued

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and that such willful misconduct caused death
or serious physical injury.
(4) Defense for acts or omissions taken pursuant to Secretary’s declaration
Notwithstanding any other provision of law,
a program planner or qualified person shall
not have engaged in ‘‘willful misconduct’’ as a
matter of law where such program planner or
qualified person acted consistent with applicable directions, guidelines, or recommendations
by the Secretary regarding the administration
or use of a covered countermeasure that is
specified in the declaration under subsection
(b) of this section, provided either the Secretary, or a State or local health authority,
was provided with notice of information regarding serious physical injury or death from
the administration or use of a covered countermeasure that is material to the plaintiff’s
alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person.
(5) Exclusion for regulated activity of manufacturer or distributor
(A) In general
If an act or omission by a manufacturer or
distributor with respect to a covered countermeasure, which act or omission is alleged
under subsection (e)(3)(A) of this section to
constitute willful misconduct, is subject to
regulation by this chapter or by the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.], such act or omission shall not constitute ‘‘willful misconduct’’ for purposes of
subsection (d) of this section if—
(i) neither the Secretary nor the Attorney General has initiated an enforcement
action with respect to such act or omission; or
(ii) such an enforcement action has been
initiated and the action has been terminated or finally resolved without a covered
remedy.
Any action or proceeding under subsection
(d) of this section shall be stayed during the
pendency of such an enforcement action.
(B) Definitions
For purposes of this paragraph, the following terms have the following meanings:
(i) Enforcement action
The term ‘‘enforcement action’’ means a
criminal prosecution, an action seeking an
injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product
because voluntary recall was refused, a
proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of
the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification
proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an
authorization under section 564 of such Act
[21 U.S.C. 360bbb–3], or a suspension or
withdrawal, based on willful misconduct,

Page 229

of an approval or clearance under chapter
V of such Act [21 U.S.C. 351 et seq.] or of a
licensure under section 262 of this title.
(ii) Covered remedy
The term ‘‘covered remedy’’ means an
outcome—
(I) that is a criminal conviction, an injunction, or a condemnation, a civil
monetary payment, a product recall, a
repair or replacement of a product, a termination of an exemption under section
505(i) or 520(g) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 355(i),
360j(g)], a debarment, an investigator
disqualification, a revocation of an authorization under section 564 of such Act
[21 U.S.C. 360bbb–3], or a suspension or
withdrawal of an approval or clearance
under chapter 5 1 of such Act or of a licensure under section 262 of this title;
and
(II) that results from a final determination by a court or from a final agency action.
(iii) Final
The terms ‘‘final’’ and ‘‘finally’’—
(I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which
an appeal of right cannot be taken or a
voluntary or stipulated dismissal; and
(II) with respect to an agency action,
or to a final resolution of an enforcement action that is an agency action,
mean an order that is not subject to further review within the agency and that
has not been reversed, vacated, enjoined,
or otherwise nullified by a final court determination or a voluntary or stipulated
dismissal.
(C) Rules of construction
(i) In general
Nothing in this paragraph shall be construed—
(I) to affect the interpretation of any
provision of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.], of
this chapter, or of any other applicable
statute or regulation; or
(II) to impair, delay, alter, or affect
the authority, including the enforcement
discretion, of the United States, of the
Secretary, of the Attorney General, or of
any other official with respect to any administrative or court proceeding under
this chapter, under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.], under title 18, or under any other
applicable statute or regulation.
(ii) Mandatory recalls
A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action.
1 So

§ 247d–6d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

in original. Probably should be chapter ‘‘V’’.

(d) Exception to immunity of covered persons
(1) In general
Subject to subsection (f) of this section, the
sole exception to the immunity from suit and
liability of covered persons set forth in subsection (a) of this section shall be for an exclusive Federal cause of action against a covered
person for death or serious physical injury
proximately caused by willful misconduct, as
defined pursuant to subsection (c) of this section, by such covered person. For purposes of
section 2679(b)(2)(B) of title 28, such a cause of
action is not an action brought for violation of
a statute of the United States under which an
action against an individual is otherwise authorized.
(2) Persons who can sue
An action under this subsection may be
brought for wrongful death or serious physical
injury by any person who suffers such injury
or by any representative of such a person.
(e) Procedures for suit
(1) Exclusive Federal jurisdiction
Any action under subsection (d) of this section shall be filed and maintained only in the
United States District Court for the District
of Columbia.
(2) Governing law
The substantive law for decision in an action
under subsection (d) of this section shall be derived from the law, including choice of law
principles, of the State in which the alleged
willful misconduct occurred, unless such law
is inconsistent with or preempted by Federal
law, including provisions of this section.
(3) Pleading with particularity
In an action under subsection (d) of this section, the complaint shall plead with particularity each element of the plaintiff’s claim, including—
(A) each act or omission, by each covered
person sued, that is alleged to constitute
willful misconduct relating to the covered
countermeasure administered to or used by
the person on whose behalf the complaint
was filed;
(B) facts supporting the allegation that
such alleged willful misconduct proximately
caused the injury claimed; and
(C) facts supporting the allegation that
the person on whose behalf the complaint
was filed suffered death or serious physical
injury.
(4)

Verification,
records

certification,

and

medical

(A) In general
In an action under subsection (d) of this
section, the plaintiff shall verify the complaint in the manner stated in subparagraph
(B) and shall file with the complaint the materials described in subparagraph (C). A complaint that does not substantially comply
with subparagraphs (B) and (C) shall not be
accepted for filing and shall not stop the
running of the statute of limitations.

§ 247d–6d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Verification requirement
(i) In general
The complaint shall include a verification, made by affidavit of the plaintiff
under oath, stating that the pleading is
true to the knowledge of the deponent, except as to matters specifically identified
as being alleged on information and belief,
and that as to those matters the plaintiff
believes it to be true.
(ii) Identification of matters alleged upon
information and belief
Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon
the knowledge of the plaintiff.
(C) Materials required
In an action under subsection (d) of this
section, the plaintiff shall file with the complaint—
(i) an affidavit, by a physician who did
not treat the person on whose behalf the
complaint was filed, certifying, and explaining the basis for such physician’s belief, that such person suffered the serious
physical injury or death alleged in the
complaint and that such injury or death
was proximately caused by the administration or use of a covered countermeasure;
and
(ii) certified medical records documenting such injury or death and such proximate causal connection.
(5) Three-judge court
Any action under subsection (d) of this section shall be assigned initially to a panel of
three judges. Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary
judgment, and matters related thereto. If such
panel has denied such motions, or if the time
for filing such motions has expired, such panel
shall refer the action to the chief judge for assignment for further proceedings, including
any trial. Section 1253 of title 28 and paragraph (3) of subsection (b) of section 2284 of
title 28 shall not apply to actions under subsection (d) of this section.
(6) Civil discovery
(A) Timing
In an action under subsection (d) of this
section, no discovery shall be allowed—
(i) before each covered person sued has
had a reasonable opportunity to file a motion to dismiss;
(ii) in the event such a motion is filed,
before the court has ruled on such motion;
and
(iii) in the event a covered person files
an interlocutory appeal from the denial of
such a motion, before the court of appeals
has ruled on such appeal.
(B) Standard
Notwithstanding any other provision of
law, the court in an action under subsection

Page 230

(d) of this section shall permit discovery
only with respect to matters directly related
to material issues contested in such action,
and the court shall compel a response to a
discovery request (including a request for
admission, an interrogatory, a request for
production of documents, or any other form
of discovery request) under Rule 37, Federal
Rules of Civil Procedure, only if the court
finds that the requesting party needs the information sought to prove or defend as to a
material issue contested in such action and
that the likely benefits of a response to such
request equal or exceed the burden or cost
for the responding party of providing such
response.
(7) Reduction in award of damages for collateral source benefits
(A) In general
In an action under subsection (d) of this
section, the amount of an award of damages
that would otherwise be made to a plaintiff
shall be reduced by the amount of collateral
source benefits to such plaintiff.
(B) Provider of collateral source benefits not
to have lien or subrogation
No provider of collateral source benefits
shall recover any amount against the plaintiff or receive any lien or credit against the
plaintiff’s recovery or be equitably or legally
subrogated to the right of the plaintiff in an
action under subsection (d) of this section.
(C) Collateral source benefit defined
For purposes of this paragraph, the term
‘‘collateral source benefit’’ means any
amount paid or to be paid in the future to or
on behalf of the plaintiff, or any service,
product, or other benefit provided or to be
provided in the future to or on behalf of the
plaintiff, as a result of the injury or wrongful death, pursuant to—
(i) any State or Federal health, sickness,
income-disability, accident, or workers’
compensation law;
(ii) any health, sickness, income-disability, or accident insurance that provides
health benefits or income-disability coverage;
(iii) any contract or agreement of any
group, organization, partnership, or corporation to provide, pay for, or reimburse
the cost of medical, hospital, dental, or income disability benefits; or
(iv) any other publicly or privately funded program.
(8) Noneconomic damages
In an action under subsection (d) of this section, any noneconomic damages may be
awarded only in an amount directly proportional to the percentage of responsibility of a
defendant for the harm to the plaintiff. For
purposes of this paragraph, the term ‘‘noneconomic damages’’ means damages for losses
for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life,
loss of society and companionship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.

Page 231

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(9) Rule 11 sanctions
Whenever a district court of the United
States determines that there has been a violation of Rule 11 of the Federal Rules of Civil
Procedure in an action under subsection (d) of
this section, the court shall impose upon the
attorney, law firm, or parties that have violated Rule 11 or are responsible for the violation, an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a
direct result of the filing of the pleading, motion, or other paper that is the subject of the
violation, including a reasonable attorney’s
fee. Such sanction shall be sufficient to deter
repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such
conduct.
(10) Interlocutory appeal
The United States Court of Appeals for the
District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered
person taken within 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the
immunity from suit conferred by subsection
(a) of this section or based on an assertion of
the exclusion under subsection (c)(5) of this
section.
(f) Actions by and against the United States
Nothing in this section shall be construed to
abrogate or limit any right, remedy, or authority that the United States or any agency thereof
may possess under any other provision of law or
to waive sovereign immunity or to abrogate or
limit any defense or protection available to the
United States or its agencies, instrumentalities,
officers, or employees under any other law, including any provision of chapter 171 of title 28
(relating to tort claims procedure).
(g) Severability
If any provision of this section, or the application of such provision to any person or circumstance, is held to be unconstitutional, the remainder of this section and the application of
such remainder to any person or circumstance
shall not be affected thereby.
(h) Rule of construction concerning National
Vaccine Injury Compensation Program
Nothing in this section, or any amendment
made by the Public Readiness and Emergency
Preparedness Act, shall be construed to affect
the National Vaccine Injury Compensation Program under subchapter XIX of this chapter.
(i) Definitions
In this section:
(1) Covered countermeasure
The
term
‘‘covered
countermeasure’’
means—
(A) a qualified pandemic or epidemic product (as defined in paragraph (7));
(B) a security countermeasure (as defined
in section 247d–6b(c)(1)(B) of this title); or
(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)(1)), biological

§ 247d–6d

product (as such term is defined by section
262(i) of this title), or device (as such term is
defined by section 201(h) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C.
321(h)) that is authorized for emergency use
in accordance with section 564 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.
360bbb–3].
(2) Covered person
The term ‘‘covered person’’, when used with
respect to the administration or use of a covered countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed,
administered, or dispensed such countermeasure; or
(v) an official, agent, or employee of a
person or entity described in clause (i),
(ii), (iii), or (iv).
(3) Distributor
The term ‘‘distributor’’ means a person or
entity engaged in the distribution of drugs,
biologics, or devices, including but not limited
to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label
distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug
warehouses; independent wholesale drug traders; and retail pharmacies.
(4) Manufacturer
The term ‘‘manufacturer’’ includes—
(A) a contractor or subcontractor of a
manufacturer;
(B) a supplier or licenser of any product,
intellectual property, service, research tool,
or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered
countermeasure; and
(C) any or all of the parents, subsidiaries,
affiliates, successors, and assigns of a manufacturer.
(5) Person
The term ‘‘person’’ includes an individual,
partnership, corporation, association, entity,
or public or private corporation, including a
Federal, State, or local government agency or
department.
(6) Program planner
The term ‘‘program planner’’ means a State
or local government, including an Indian
tribe, a person employed by the State or local
government, or other person who supervised or
administered a program with respect to the
administration, dispensing, distribution, provision, or use of a security countermeasure or
a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied
technical or scientific advice or assistance or
provides a facility to administer or use a cov-

§ 247d–6e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ered countermeasure in accordance with a declaration under subsection (b) of this section.
(7) Qualified pandemic or epidemic product
The term ‘‘qualified pandemic or epidemic
product’’ means a drug (as such term is defined in section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),2
biological product (as such term is defined by
section 262(i) of this title), or device (as such
term is defined by section 201(h) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C.
321(h)) 2 that is—
(A)(i) a product manufactured, used, designed, developed, modified, licensed, or procured—
(I) to diagnose, mitigate, prevent, treat,
or cure a pandemic or epidemic; or
(II) to limit the harm such pandemic or
epidemic might otherwise cause; or
(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat,
or cure a serious or life-threatening disease
or condition caused by a product described
in clause (i); and
(B)(i) approved or cleared under chapter V
of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 351 et seq.] or licensed under section 262 of this title;
(ii) the object of research for possible use
as described by subparagraph (A) and is the
subject of an exemption under section 505(i)
or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or
(iii) authorized for emergency use in accordance with section 564 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.
360bbb–3].
(8) Qualified person
The term ‘‘qualified person’’, when used with
respect to the administration or use of a covered countermeasure, means—
(A) a licensed health professional or other
individual who is authorized to prescribe,
administer, or dispense such countermeasures under the law of the State in
which the countermeasure was prescribed,
administered, or dispensed; or
(B) a person within a category of persons
so identified in a declaration by the Secretary under subsection (b) of this section.
(9) Security countermeasure
The term ‘‘security countermeasure’’ has
the meaning given such term in section
247d–6b(c)(1)(B) of this title.
(10) Serious physical injury
The term ‘‘serious physical injury’’ means
an injury that—
(A) is life threatening;
(B) results in permanent impairment of a
body function or permanent damage to a
body structure; or
(C) necessitates medical or surgical intervention to preclude permanent impairment
of a body function or permanent damage to
a body structure.
2 So in original. A third closing parenthesis probably should
appear.

Page 232

(July 1, 1944, ch. 373, title III, § 319F–3, as added
Pub. L. 109–148, div. C, § 2, Dec. 30, 2005, 119 Stat.
2818.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsecs. (b)(8)(B), (c)(5)(A), (B)(i), (ii)(I), (C)(i), and
(i)(7)(B)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9
(§ 301 et seq.) of Title 21, Food and Drugs. Chapter V of
the Act is classified generally to subchapter V (§ 351 et
seq.) of chapter 9 of Title 21. For complete classification of this Act to the Code, see section 301 of Title 21
and Tables.
The Federal Rules of Civil Procedure, referred to in
subsec. (e)(6)(B), (9), are set out in the Appendix to
Title 28, Judiciary and Judicial Procedure.
The Public Readiness and Emergency Preparedness
Act, referred to in subsec. (h), is div. C of Pub. L.
109–148, Dec. 30, 2005, 119 Stat. 2818, which enacted this
section, section 247d–6e of this title, and provisions set
out as a note under section 201 of this title. For complete classification of this Act to the Code, see Short
Title of 2005 Amendment note set out under section 201
of this title and Tables.

§ 247d–6e. Covered countermeasure process
(a) Establishment of Fund
Upon the issuance by the Secretary of a declaration under section 247d–6d(b) of this title,
there is hereby established in the Treasury an
emergency fund designated as the ‘‘Covered
Countermeasure Process Fund’’ for purposes of
providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or
use of a covered countermeasure pursuant to
such declaration, which Fund shall consist of
such amounts designated as emergency appropriations under section 402 of H. Con. Res. 95 of
the 109th Congress, this emergency designation
shall remain in effect through October 1, 2006.
(b) Payment of compensation
(1) In general
If the Secretary issues a declaration under
247d–6d(b) of this title, the Secretary shall,
after amounts have by law been provided for
the Fund under subsection (a) of this section,
provide compensation to an eligible individual
for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to such declaration.
(2) Elements of compensation
The compensation that shall be provided
pursuant to paragraph (1) shall have the same
elements, and be in the same amount, as is
prescribed by sections 239c, 239d, and 239e of
this title in the case of certain individuals injured as a result of administration of certain
countermeasures against smallpox, except
that section 239e(a)(2)(B) of this title shall not
apply.
(3) Rule of construction
Neither reasonable and necessary medical
benefits nor lifetime total benefits for lost employment income due to permanent and total
disability shall be limited by section 239e of
this title.
(4) Determination of eligibility and compensation
Except as provided in this section, the procedures for determining, and for reviewing a de-

Page 233

TITLE 42—THE PUBLIC HEALTH AND WELFARE

termination of, whether an individual is an eligible individual, whether such individual has
sustained a covered injury, whether compensation may be available under this section, and
the amount of such compensation shall be
those stated in section 239a of this title (other
than in subsection (d)(2) of such section), in
regulations issued pursuant to that section,
and in such additional or alternate regulations
as the Secretary may promulgate for purposes
of this section. In making determinations
under this section, other than those described
in paragraph (5)(A) as to the direct causation
of a covered injury, the Secretary may only
make such determination based on compelling, reliable, valid, medical and scientific evidence.
(5) Covered countermeasure injury table
(A) In general
The Secretary shall by regulation establish a table identifying covered injuries that
shall be presumed to be directly caused by
the administration or use of a covered countermeasure and the time period in which the
first symptom or manifestation of onset of
each such adverse effect must manifest in
order for such presumption to apply. The
Secretary may only identify such covered
injuries, for purpose of inclusion on the
table, where the Secretary determines, based
on compelling, reliable, valid, medical and
scientific evidence that administration or
use of the covered countermeasure directly
caused such covered injury.
(B) Amendments
The provisions of section 239b of this title
(other than a provision of subsection (a)(2) of
such section that relates to accidental
vaccinia inoculation) shall apply to the
table established under this section.
(C) Judicial review
No court of the United States, or of any
State, shall have subject matter jurisdiction
to review, whether by mandamus or otherwise, any action by the Secretary under this
paragraph.
(6) Meanings of terms
In applying sections 239a, 239b, 239c, 239d,
and 239e of this title for purposes of this section—
(A) the terms ‘‘vaccine’’ and ‘‘smallpox
vaccine’’ shall be deemed to mean a covered
countermeasure;
(B) the terms ‘‘smallpox vaccine injury
table’’ and ‘‘table established under section
239b of this title’’ shall be deemed to refer to
the table established under paragraph (4);
and
(C) other terms used in those sections shall
have the meanings given to such terms by
this section.
(c) Voluntary program
The Secretary shall ensure that a State, local,
or Department of Health and Human Services
plan to administer or use a covered countermeasure is consistent with any declaration
under 247d–6d of this title and any applicable

§ 247d–6e

guidelines of the Centers for Disease Control and
Prevention and that potential participants are
educated with respect to contraindications, the
voluntary nature of the program, and the availability of potential benefits and compensation
under this part.
(d) Exhaustion; exclusivity; election
(1) Exhaustion
Subject to paragraph (5), a covered individual may not bring a civil action under section
247d–6d(d) of this title against a covered person (as such term is defined in section
247d–6d(i)(2) of this title) unless such individual has exhausted such remedies as are available under subsection (a) of this section, except that if amounts have not by law been provided for the Fund under subsection (a) of this
section, or if the Secretary fails to make a
final determination on a request for benefits
or compensation filed in accordance with the
requirements of this section within 240 days
after such request was filed, the individual
may seek any remedy that may be available
under section 247d–6d(d) of this title.
(2) Tolling of statute of limitations
The time limit for filing a civil action under
section 247d–6d(d) of this title for an injury or
death shall be tolled during the pendency of a
claim for compensation under subsection (a) of
this section.
(3) Rule of construction
This section shall not be construed as superseding or otherwise affecting the application
of a requirement, under chapter 171 of title 28,
to exhaust administrative remedies.
(4) Exclusivity
The remedy provided by subsection (a) of
this section shall be exclusive of any other
civil action or proceeding for any claim or suit
this section encompasses, except for a proceeding under section 247d–6d of this title.
(5) Election
If under subsection (a) of this section the
Secretary determines that a covered individual qualifies for compensation, the individual
has an election to accept the compensation or
to bring an action under section 247d–6d(d) of
this title. If such individual elects to accept
the compensation, the individual may not
bring such an action.
(e) Definitions
For purposes of this section, the following
terms shall have the following meanings:
(1) Covered countermeasure
The term ‘‘covered countermeasure’’ has the
meaning given such term in section 247d–6d of
this title.
(2) Covered individual
The term ‘‘covered individual’’, with respect
to administration or use of a covered countermeasure pursuant to a declaration, means an
individual—
(A) who is in a population specified in such
declaration, and with respect to whom the
administration or use of the covered coun-

§ 247d–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

termeasure satisfies the other specifications
of such declaration; or
(B) who uses the covered countermeasure,
or to whom the covered countermeasure is
administered, in a good faith belief that the
individual is in the category described by
subparagraph (A).
(3) Covered injury
The term ‘‘covered injury’’ means serious
physical injury or death.
(4) Declaration
The term ‘‘declaration’’ means a declaration
under section 247d–6d(b) of this title.
(5) Eligible individual
The term ‘‘eligible individual’’ means an individual who is determined, in accordance
with subsection (b) of this section, to be a covered individual who sustains a covered injury.
(July 1, 1944, ch. 373, title III, § 319F–4, as added
Pub. L. 109–148, div. C, § 3, Dec. 30, 2005, 119 Stat.
2829.)
REFERENCES IN TEXT
H. Con. Res. 95 of the 109th Congress, referred to in
subsec. (a), is H. Con. Res. 95, Apr. 28, 2005, 119 Stat.
3633, which is not classified to the Code.

§ 247d–7. Demonstration program to enhance bioterrorism training, coordination, and readiness
(a) In general
The Secretary shall make grants to not more
than three eligible entities to carry out demonstration programs to improve the detection of
pathogens likely to be used in a bioterrorist attack, the development of plans and measures to
respond to bioterrorist attacks, and the training
of personnel involved with the various responsibilities and capabilities needed to respond to
acts of bioterrorism upon the civilian population. Such awards shall be made on a competitive basis and pursuant to scientific and technical review.
(b) Eligible entities
Eligible entities for grants under subsection
(a) of this section are States, political subdivisions of States, and public or private non-profit
organizations.
(c) Specific criteria
In making grants under subsection (a) of this
section, the Secretary shall take into account
the following factors:
(1) Whether the eligible entity involved is
proximate to, and collaborates with, a major
research university with expertise in scientific
training, identification of biological agents,
medicine, and life sciences.
(2) Whether the entity is proximate to, and
collaborates with, a laboratory that has expertise in the identification of biological agents.
(3) Whether the entity demonstrates, in the
application for the program, support and participation of State and local governments and
research institutions in the conduct of the
program.
(4) Whether the entity is proximate to, and
collaborates with, or is, an academic medical

Page 234

center that has the capacity to serve an uninsured or underserved population, and is
equipped to educate medical personnel.
(5) Such other factors as the Secretary determines to be appropriate.
(d) Duration of award
The period during which payments are made
under a grant under subsection (a) of this section may not exceed 5 years. The provision of
such payments shall be subject to annual approval by the Secretary of the payments and
subject to the availability of appropriations for
the fiscal year involved to make the payments.
(e) Supplement not supplant
Grants under subsection (a) of this section
shall be used to supplement, and not supplant,
other Federal, State, or local public funds provided for the activities described in such subsection.
(f) Government Accountability Office report
Not later than 180 days after the conclusion of
the demonstration programs carried out under
subsection (a) of this section, the Comptroller
General of the United States shall submit to the
Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations
of the Senate, and the Committee on Commerce
and the Committee on Appropriations of the
House of Representatives, a report that describes the ability of grantees under such subsection to detect pathogens likely to be used in
a bioterrorist attack, develop plans and measures for dealing with such threats, and train personnel involved with the various responsibilities
and capabilities needed to deal with bioterrorist
threats.
(g) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $6,000,000 for fiscal year
2001, and such sums as may be necessary
through fiscal year 2006.
(July 1, 1944, ch. 373, title III, § 319G, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2323; amended Pub. L. 108–271, § 8(b), July 7,
2004, 118 Stat. 814.)
AMENDMENTS
2004—Subsec. (f). Pub. L. 108–271 substituted ‘‘Government Accountability Office’’ for ‘‘General Accounting
Office’’ in heading.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 247d–7a. Grants regarding training and education of certain health professionals
(a) In general
The Secretary may make awards of grants and
cooperative agreements to appropriate public
and nonprofit private health or educational entities, including health professions schools and
programs as defined in section 295p of this title,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

for the purpose of providing low-interest loans,
partial scholarships, partial fellowships, revolving loan funds, or other cost-sharing forms of assistance for the education and training of individuals in any category of health professions for
which there is a shortage that the Secretary determines should be alleviated in order to prepare
for or respond effectively to bioterrorism and
other public health emergencies.
(b) Authority regarding non-Federal contributions
The Secretary may require as a condition of
an award under subsection (a) of this section
that a grantee under such subsection provide
non-Federal contributions toward the purpose
described in such subsection.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2002 through 2006.
(July 1, 1944, ch. 373, title III, § 319H, as added
Pub. L. 107–188, title I, § 106, June 12, 2002, 116
Stat. 607.)
§ 247d–7b. Emergency system for advance registration of health professions volunteers
(a) In general
Not later than 12 months after December 19,
2006, the Secretary shall link existing State verification systems to maintain a single national
interoperable network of systems, each system
being maintained by a State or group of States,
for the purpose of verifying the credentials and
licenses of health care professionals who volunteer to provide health services during a public
health emergency.
(b) Requirements
The interoperable network of systems established under subsection (a) (referred to in this
section as the ‘‘verification network’’) shall include—
(1) with respect to each volunteer health
professional included in the verification network—
(A) information necessary for the rapid
identification of, and communication with,
such professionals; and
(B) the credentials, certifications, licenses,
and relevant training of such individuals;
and
(2) the name of each member of the Medical
Reserve Corps, the National Disaster Medical
System, and any other relevant federallysponsored or administered programs determined necessary by the Secretary.
(c) Other assistance
The Secretary may make grants and provide
technical assistance to States and other public
or nonprofit private entities for activities relating to the verification network developed under
subsection (a) of this section.
(d) Accessibility
The Secretary shall ensure that the verification network is electronically accessible by
State, local, and tribal health departments and

§ 247d–7b

can be linked with the identification cards
under section 300hh–15 of this title.
(e) Confidentiality
The Secretary shall establish and require the
application of and compliance with measures to
ensure the effective security of, integrity of, and
access to the data included in the verification
network.
(f) Coordination
The Secretary shall coordinate with the Secretary of Veterans Affairs and the Secretary of
Homeland Security to assess the feasibility of
integrating the verification network under this
section with the VetPro system of the Department of Veterans Affairs and the National
Emergency Responder Credentialing System of
the Department of Homeland Security. The Secretary shall, if feasible, integrate the verification network under this section with such
VetPro system and the National Emergency Responder Credentialing System.
(g) Updating of information
The States that are participants in the verification network shall, on at least a quarterly
basis, work with the Director to provide for the
updating of the information contained in the
verification network.
(h) Clarification
Inclusion of a health professional in the verification network shall not constitute appointment of such individual as a Federal employee
for any purpose, either under section 300hh–11(c)
of this title or otherwise. Such appointment
may only be made under section 300hh–11 or
300hh–15 of this title.
(i) Health care provider licenses
The Secretary shall encourage States to establish and implement mechanisms to waive the application of licensing requirements applicable to
health professionals, who are seeking to provide
medical services (within their scope of practice),
during a national, State, local, or tribal public
health emergency upon verification that such
health professionals are licensed and in good
standing in another State and have not been disciplined by any State health licensing or disciplinary board.
(j) Rule of construction
This section may not be construed as authorizing the Secretary to issue requirements regarding the provision by the States of credentials, licenses, accreditations, or hospital privileges.
(k) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $2,000,000
for fiscal year 2002, and such sums as may be
necessary for each of the fiscal years 2003
through 2011.
(July 1, 1944, ch. 373, title III, § 319I, as added
Pub. L. 107–188, title I, § 107, June 12, 2002, 116
Stat. 608; amended Pub. L. 109–417, title III,
§ 303(b), Dec. 19, 2006, 120 Stat. 2857.)
AMENDMENTS
2006—Subsecs. (a), (b). Pub. L. 109–417, § 303(b)(2),
added subsecs. (a) and (b) and struck out former sub-

§ 247d–7c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

secs. (a) and (b) which related to establishment of a
verification system and provisions regarding its
promptness and efficiency.
Subsec. (c). Pub. L. 109–417, § 303(b)(3), substituted
‘‘network’’ for ‘‘system’’.
Subsecs. (d) to (k). Pub. L. 109–417, § 303(b)(1), (4), (5),
added subsecs. (d) to (i), redesignated former subsecs.
(e) and (f) as (j) and (k), respectively, substituted ‘‘2011’’
for ‘‘2006’’ in subsec. (k), and struck out heading and
text of former subsec. (d). Text read as follows: ‘‘The
Secretary may encourage each State to provide legal
authority during a public health emergency for health
professionals authorized in another State to provide
certain health services to provide such health services
in the State.’’

§ 247d–7c. Supplies and services in lieu of award
funds
(a) In general
Upon the request of a recipient of an award
under any of sections 247d through 247d–7b of
this title or section 247d–7d of this title, the Secretary may, subject to subsection (b) of this section, provide supplies, equipment, and services
for the purpose of aiding the recipient in carrying out the purposes for which the award is
made and, for such purposes, may detail to the
recipient any officer or employee of the Department of Health and Human Services.
(b) Corresponding reduction in payments
With respect to a request described in subsection (a) of this section, the Secretary shall
reduce the amount of payments under the award
involved by an amount equal to the costs of detailing personnel and the fair market value of
any supplies, equipment, or services provided by
the Secretary. The Secretary shall, for the payment of expenses incurred in complying with
such request, expend the amounts withheld.
(July 1, 1944, ch. 373, title III, § 319J, as added
Pub. L. 107–188, title I, § 110, June 12, 2002, 116
Stat. 611.)
§ 247d–7d. Security for countermeasure development and production
(a) In general
The Secretary, in consultation with the Attorney General and the Secretary of Defense, may
provide technical or other assistance to provide
security to persons or facilities that conduct development, production, distribution, or storage
of priority countermeasures (as defined in section 247d–6(h)(4) of this title).
(b) Guidelines
The Secretary may develop guidelines to enable entities eligible to receive assistance under
subsection (a) of this section to secure their facilities against potential terrorist attack.
(July 1, 1944, ch. 373, title III, § 319K, as added
Pub. L. 107–188, title I, § 124, June 12, 2002, 116
Stat. 614.)
§ 247d–7e. Biomedical Advanced Research and
Development Authority
(a) Definitions
In this section:
(1) BARDA
The term ‘‘BARDA’’ means the Biomedical
Advanced Research and Development Authority.

Page 236

(2) Fund
The term ‘‘Fund’’ means the Biodefense
Medical Countermeasure Development Fund
established under subsection (d).
(3) Other transactions
The term ‘‘other transactions’’ means transactions, other than procurement contracts,
grants, and cooperative agreements, such as
the Secretary of Defense may enter into under
section 2371 of title 10.
(4) Qualified countermeasure
The term ‘‘qualified countermeasure’’ has
the meaning given such term in section
247d–6a of this title.
(5) Qualified pandemic or epidemic product
The term ‘‘qualified pandemic or epidemic
product’’ has the meaning given the term in
section 247d–6d of this title.
(6) Advanced research and development
(A) In general
The term ‘‘advanced research and development’’ means, with respect to a product that
is or may become a qualified countermeasure or a qualified pandemic or epidemic
product, activities that predominantly—
(i) are conducted after basic research and
preclinical development of the product;
and
(ii) are related to manufacturing the
product on a commercial scale and in a
form that satisfies the regulatory requirements under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] or
under section 262 of this title.
(B) Activities included
The term under subparagraph (A) includes—
(i) testing of the product to determine
whether the product may be approved,
cleared, or licensed under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.] or under section 262 of this title
for a use that is or may be the basis for
such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;
(ii) design and development of tests or
models, including animal models, for such
testing;
(iii) activities to facilitate manufacture
of the product on a commercial scale with
consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge
capacity;
(iv) activities to improve the shelf-life of
the product or technologies for administering the product; and
(v) such other activities as are part of
the advanced stages of testing, refinement,
improvement, or preparation of the product for such use and as are specified by the
Secretary.
(7) Security countermeasure
The term ‘‘security countermeasure’’ has
the meaning given such term in section
247d–6b of this title.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(8) Research tool
The term ‘‘research tool’’ means a device,
technology, biological material (including a
cell line or an antibody), reagent, animal
model, computer system, computer software,
or analytical technique that is developed to
assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products.
(9) Program manager
The term ‘‘program manager’’ means an individual appointed to carry out functions
under this section and authorized to provide
project oversight and management of strategic
initiatives.
(10) Person
The term ‘‘person’’ includes an individual,
partnership, corporation, association, entity,
or public or private corporation, and a Federal, State, or local government agency or department.
(b) Strategic plan for countermeasure research,
development, and procurement
(1) In general
Not later than 6 months after December 19,
2006, the Secretary shall develop and make
public a strategic plan to integrate biodefense
and emerging infectious disease requirements
with the advanced research and development,
strategic initiatives for innovation, and the
procurement of qualified countermeasures and
qualified pandemic or epidemic products. The
Secretary shall carry out such activities as
may be practicable to disseminate the information contained in such plan to persons who
may have the capacity to substantially contribute to the activities described in such strategic plan. The Secretary shall update and incorporate such plan as part of the National
Health Security Strategy described in section
300hh–1 of this title.
(2) Content
The strategic plan under paragraph (1) shall
guide—
(A) research and development, conducted
or supported by the Department of Health
and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological,
chemical, radiological, and nuclear agents
and to emerging infectious diseases;
(B) innovation in technologies that may
assist advanced research and development of
qualified countermeasures and qualified pandemic or epidemic products (such research
and development referred to in this section
as ‘‘countermeasure and product advanced
research and development’’); and
(C) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department.
(c) Biomedical Advanced Research and Development Authority
(1) Establishment
There is established within the Department
of Health and Human Services the Biomedical
Advanced Research and Development Authority.

§ 247d–7e

(2) In general
Based upon the strategic plan described in
subsection (b), the Secretary shall coordinate
the acceleration of countermeasure and product advanced research and development by—
(A) facilitating collaboration between the
Department of Health and Human Services
and other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
(B) promoting countermeasure and product advanced research and development;
(C) facilitating contacts between interested persons and the offices or employees
authorized by the Secretary to advise such
persons regarding requirements under the
Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.] and under section 262 of
this title; and
(D) promoting innovation to reduce the
time and cost of countermeasure and product advanced research and development.
(3) Director
The BARDA shall be headed by a Director
(referred to in this section as the ‘‘Director’’)
who shall be appointed by the Secretary and
to whom the Secretary shall delegate such
functions and authorities as necessary to implement this section.
(4) Duties
(A) Collaboration
To carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i) facilitate and increase the expeditious
and direct communication between the Department of Health and Human Services
and relevant persons with respect to countermeasure and product advanced research
and development, including by—
(I) facilitating such communication regarding the processes for procuring such
advanced research and development with
respect to qualified countermeasures and
qualified pandemic or epidemic products
of interest; and
(II) soliciting information about and
data from research on potential qualified
countermeasures and qualified pandemic
or epidemic products and related technologies;
(ii) at least annually—
(I) convene meetings with representatives from relevant industries, academia,
other Federal agencies, international
agencies as appropriate, and other interested persons;
(II) sponsor opportunities to demonstrate the operation and effectiveness
of relevant biodefense countermeasure
technologies; and
(III) convene such working groups on
countermeasure and product advanced
research and development as the Secretary may determine are necessary to
carry out this section; and
(iii) carry out the activities described in
section 405 of the Pandemic and All-Hazards Preparedness Act.

§ 247d–7e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Support advanced research and development
To carry out the purpose described in paragraph (2)(B), the Secretary shall—
(i) conduct ongoing searches for, and
support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
(ii) direct and coordinate the countermeasure and product advanced research
and development activities of the Department of Health and Human Services;
(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development and innovation in such areas as the Secretary
may identify as priority unmet need areas;
and
(iv) award contracts, grants, cooperative
agreements, and enter into other transactions, for countermeasure and product
advanced research and development.
(C) Facilitating advice
To carry out the purpose described in paragraph (2)(C) the Secretary shall—
(i) connect interested persons with the
offices or employees authorized by the
Secretary to advise such persons regarding
the regulatory requirements under the
Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.] and under section 262 of
this title related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products; and
(ii) with respect to persons performing
countermeasure and product advanced research and development funded under this
section, enable such offices or employees
to provide to the extent practicable such
advice in a manner that is ongoing and
that is otherwise designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure.
(D) Supporting innovation
To carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements,
or enter into other transactions, such as
prize payments, to promote—
(i) innovation in technologies that may
assist countermeasure and product advanced research and development;
(ii) research on and development of research tools and other devices and technologies; and
(iii) research to promote strategic initiatives, such as rapid diagnostics, broad
spectrum antimicrobials, and vaccine
manufacturing technologies.
(5) Transaction authorities
(A) Other transactions
(i) In general
The Secretary shall have the authority
to enter into other transactions under this
subsection in the same manner as the Sec-

Page 238

retary of Defense enters into such transactions under section 2371 of title 10.
(ii) Limitations on authority
(I) In general
Subsections (b), (c), and (h) of section
845 of the National Defense Authorization Act for Fiscal Year 1994 (10 U.S.C.
2371 note) shall apply to other transactions under this subparagraph as if
such transactions were for prototype
projects described by subsection (a) of
such section 845.
(II) Written determinations required
The authority of this subparagraph
may be exercised for a project that is expected to cost the Department of Health
and Human Services in excess of
$20,000,000 only upon a written determination by the senior procurement executive for the Department (as designated for purpose of section 1702(c) of
title 41), that the use of such authority
is essential to promoting the success of
the project. The authority of the senior
procurement executive under this subclause may not be delegated.
(iii) Guidelines
The Secretary shall establish guidelines
regarding the use of the authority under
clause (i). Such guidelines shall include
auditing requirements.
(B) Expedited authorities
(i) In general
In awarding contracts, grants, and cooperative agreements, and in entering into
other transactions under subparagraph (B)
or (D) of paragraph (4), the Secretary shall
have the expedited procurement authorities, the authority to expedite peer review,
and the authority for personal services
contracts, supplied by subsections (b), (c),
and (d) of section 247d–6a of this title.
(ii) Application of provisions
Provisions in such section 247d–6a of this
title that apply to such authorities and
that require institution of internal controls, limit review, provide for Federal
Tort Claims Act coverage of personal services contractors, and commit decisions to
the discretion of the Secretary shall apply
to the authorities as exercised pursuant to
this paragraph.
(iii) Authority to limit competition
For
purposes
of
applying
section
247d–6a(b)(1)(D) of this title to this paragraph, the phrase ‘‘BioShield Program
under the Project BioShield Act of 2004’’
shall be deemed to mean the countermeasure and product advanced research
and development program under this section.
(iv) Availability of data
The Secretary shall require that, as a
condition of being awarded a contract,
grant, cooperative agreement, or other
transaction under subparagraph (B) or (D)

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

of paragraph (4), a person make available
to the Secretary on an ongoing basis, and
submit upon request to the Secretary, all
data related to or resulting from countermeasure and product advanced research
and development carried out pursuant to
this section.
(C) Advance payments; advertising
The Secretary may waive the requirements of section 3324(a) of title 31 or section
6101 of title 41 upon the determination by
the Secretary that such waiver is necessary
to obtain countermeasures or products under
this section.
(D) Milestone-based payments allowed
In awarding contracts, grants, and cooperative agreements, and in entering into other
transactions, under this section, the Secretary may use milestone-based awards and
payments.
(E) Foreign nationals eligible
The Secretary may under this section
award contracts, grants, and cooperative
agreements to, and may enter into other
transactions with, highly qualified foreign
national persons outside the United States,
alone or in collaboration with American participants, when such transactions may inure
to the benefit of the American people.
(F) Establishment of research centers
The Secretary may assess the feasibility
and appropriateness of establishing, through
contract, grant, cooperative agreement, or
other transaction, an arrangement with an
existing research center in order to achieve
the goals of this section. If such an agreement is not feasible and appropriate, the
Secretary may establish one or more federally-funded research and development centers, or university-affiliated research centers, in accordance with section 3304(a)(3) of
title 41.
(6) At-risk individuals
In carrying out the functions under this section, the Secretary may give priority to the
advanced research and development of qualified countermeasures and qualified pandemic
or epidemic products that are likely to be safe
and effective with respect to children, pregnant women, elderly, and other at-risk individuals.
(7) Personnel authorities
(A) Specially qualified scientific and professional personnel
(i) In general
In addition to any other personnel authorities, the Secretary may—
(I) without regard to those provisions
of title 5 governing appointments in the
competitive service, appoint highly
qualified individuals to scientific or professional positions in BARDA, such as
program managers, to carry out this section; and
(II) compensate them in the same manner and subject to the same terms and

§ 247d–7e

conditions in which individuals appointed under section 9903 of such title
are compensated, without regard to the
provisions of chapter 51 and subchapter
III of chapter 53 of such title relating to
classification and General Schedule pay
rates.
(ii) Manner of exercise of authority
The authority provided for in this subparagraph shall be exercised subject to the
same limitations described in section
247d–6a(e)(2) of this title.
(iii) Term of appointment
The term limitations described in section 9903(c) of title 5 shall apply to appointments under this subparagraph, except that the references to the ‘‘Secretary’’ and to the ‘‘Department of Defense’s national security missions’’ shall
be deemed to be to the Secretary of Health
and Human Services and to the mission of
the Department of Health and Human
Services under this section.
(B) Special consultants
In carrying out this section, the Secretary
may appoint special consultants pursuant to
section 209(f) of this title.
(C) Limitation
(i) In general
The Secretary may hire up to 100 highly
qualified individuals, or up to 50 percent of
the total number of employees, whichever
is less, under the authorities provided for
in subparagraphs (A) and (B).
(ii) Report
The Secretary shall report to Congress
on a biennial basis on the implementation
of this subparagraph.
(d) Fund
(1) Establishment
There is established the Biodefense Medical
Countermeasure Development Fund, which
shall be available to carry out this section in
addition to such amounts as are otherwise
available for this purpose.
(2) Funding
To carry out the purposes of this section,
there are authorized to be appropriated to the
Fund—
(A) $1,070,000,000 for fiscal years 2006
through 2008, the amounts to remain available until expended; and
(B) such sums as may be necessary for subsequent fiscal years, the amounts to remain
available until expended.
(e) Inapplicability of certain provisions
(1) Disclosure
(A) In general
The Secretary shall withhold from disclosure under section 552 of title 5 specific technical data or scientific information that is
created or obtained during the countermeasure and product advanced research and
development carried out under subsection (c)

§ 247d–7f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

that reveals significant and not otherwise
publicly known vulnerabilities of existing
medical or public health defenses against biological, chemical, nuclear, or radiological
threats. Such information shall be deemed
to be information described in section
552(b)(3) of title 5.
(B) Review
Information subject to nondisclosure
under subparagraph (A) shall be reviewed by
the Secretary every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or necessity of continued nondisclosure.
(C) Sunset
This paragraph shall cease to have force or
effect on the date that is 7 years after December 19, 2006.
(2) Review
Notwithstanding section 14 of the Federal
Advisory Committee Act, a working group of
BARDA under this section and the National
Biodefense Science Board under section 247d–7f
of this title shall each terminate on the date
that is 5 years after the date on which each
such group or Board, as applicable, was established. Such 5-year period may be extended by
the Secretary for one or more additional 5year periods if the Secretary determines that
any such extension is appropriate.
(July 1, 1944, ch. 373, title III, § 319L, as added
Pub. L. 109–417, title IV, § 401, Dec. 19, 2006, 120
Stat. 2865.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsecs. (a)(6)(A)(ii), (B)(i) and (c)(2)(C), (4)(C)(i),
is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (§ 301 et seq.)
of Title 21, Food and Drugs. For complete classification
of this Act to the Code, see section 301 of Title 21 and
Tables.
Section 405 of the Pandemic and All-Hazards Preparedness Act, referred to in subsec. (c)(4)(A)(iii), is
section 405 of Pub. L. 109–417, which is set out as a note
under section 247d–6a of this title.
Section 845 of the National Defense Authorization
Act for Fiscal Year 1994, referred to in subsec.
(c)(5)(A)(ii)(I), is section 845 of Pub. L. 103–160, which is
set out as a note under section 2371 of Title 10, Armed
Forces.
The Federal Tort Claims Act, referred to in subsec.
(c)(5)(B)(ii), is title IV of act Aug. 2, 1946, ch. 753, 60
Stat. 842, which was classified principally to chapter 20
(§§ 921, 922, 931–934, 941–946) of former Title 28, Judicial
Code and Judiciary. Title IV of act Aug. 2, 1946, was
substantially repealed and reenacted as sections 1346(b)
and 2671 et seq. of Title 28, Judiciary and Judicial Procedure, by act June 25, 1948, ch. 646, 62 Stat. 992, the
first section of which enacted Title 28. The Federal
Tort Claims Act is also commonly used to refer to
chapter 171 of Title 28, Judiciary and Judicial Procedure. For complete classification of title IV to the
Code, see Tables. For distribution of former sections of
Title 28 into the revised Title 28, see Table at the beginning of Title 28.
Section 14 of the Federal Advisory Committee Act,
referred to in subsec. (e)(2), is section 14 of Pub. L.
92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.
CODIFICATION
In subsec. (c)(5)(A)(ii)(II), ‘‘section 1702(c) of title 41’’
substituted for ‘‘section 16(c) of the Office of Federal

Page 240

Procurement Policy Act (41 U.S.C. 414(c))’’ on authority
of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854,
which Act enacted Title 41, Public Contracts.
In subsec. (c)(5)(C), ‘‘section 6101 of title 41’’ substituted for ‘‘section 3709 of the Revised Statutes of the
United States (41 U.S.C. 5)’’ on authority of Pub. L.
111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
In subsec. (c)(5)(F), ‘‘section 3304(a)(3) of title 41’’ substituted for ‘‘section 303(c)(3) of the Federal Property
and Administrative Services Act of 1949 (41 U.S.C.
253(c)(3))’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4,
2011, 124 Stat. 3854, which Act enacted Title 41, Public
Contracts.

§ 247d–7f. National Biodefense Science Board and
working groups
(a) In general
(1) Establishment and function
The Secretary shall establish the National
Biodefense Science Board (referred to in this
section as the ‘‘Board’’) to provide expert advice and guidance to the Secretary on scientific, technical and other matters of special
interest to the Department of Health and
Human Services regarding current and future
chemical, biological, nuclear, and radiological
agents, whether naturally occurring, accidental, or deliberate.
(2) Membership
The membership of the Board shall be comprised of individuals who represent the Nation’s preeminent scientific, public health, and
medical experts, as follows—
(A) such Federal officials as the Secretary
may determine are necessary to support the
functions of the Board;
(B) four individuals representing the pharmaceutical, biotechnology, and device industries;
(C) four individuals representing academia;
and
(D) five other members as determined appropriate by the Secretary, of whom—
(i) one such member shall be a practicing
healthcare professional; and
(ii) one such member shall be an individual from an organization representing
healthcare consumers.
(3) Term of appointment
A member of the Board described in subparagraph (B), (C), or (D) of paragraph (2) shall
serve for a term of 3 years, except that the
Secretary may adjust the terms of the initial
Board appointees in order to provide for a
staggered term of appointment for all members.
(4) Consecutive appointments; maximum terms
A member may be appointed to serve not
more than 3 terms on the Board and may serve
not more than 2 consecutive terms.
(5) Duties
The Board shall—
(A) advise the Secretary on current and future trends, challenges, and opportunities
presented by advances in biological and life
sciences, biotechnology, and genetic engineering with respect to threats posed by naturally occurring infectious diseases and

Page 241

TITLE 42—THE PUBLIC HEALTH AND WELFARE

chemical, biological, radiological, and nuclear agents;
(B) at the request of the Secretary, review
and consider any information and findings
received from the working groups established under subsection (b); and
(C) at the request of the Secretary, provide
recommendations and findings for expanded,
intensified, and coordinated biodefense research and development activities.
(6) Meetings
(A) Initial meeting
Not later than one year after December 19,
2006, the Secretary shall hold the first meeting of the Board.
(B) Subsequent meetings
The Board shall meet at the call of the
Secretary, but in no case less than twice annually.
(7) Vacancies
Any vacancy in the Board shall not affect its
powers, but shall be filled in the same manner
as the original appointment.
(8) Chairperson
The Secretary shall appoint a chairperson
from among the members of the Board.
(9) Powers
(A) Hearings
The Board may hold such hearings, sit and
act at such times and places, take such testimony, and receive such evidence as the
Board considers advisable to carry out this
subsection.
(B) Postal services
The Board may use the United States
mails in the same manner and under the
same conditions as other departments and
agencies of the Federal Government.
(10) Personnel
(A) Employees of the Federal Government
A member of the Board that is an employee of the Federal Government may not
receive additional pay, allowances, or benefits by reason of the member’s service on the
Board.
(B) Other members
A member of the Board that is not an employee of the Federal Government may be
compensated at a rate not to exceed the
daily equivalent of the annual rate of basic
pay prescribed for level IV of the Executive
Schedule under section 5315 of title 5 for
each day (including travel time) during
which the member is engaged in the actual
performance of duties as a member of the
Board.
(C) Travel expenses
Each member of the Board shall receive
travel expenses, including per diem in lieu of
subsistence, in accordance with applicable
provisions under subchapter I of chapter 57
of title 5.
(D) Detail of Government employees
Any Federal Government employee may be
detailed to the Board with the approval for

§ 247d–8

the contributing agency without reimbursement, and such detail shall be without interruption or loss of civil service status or
privilege.
(b) Other working groups
The Secretary may establish a working group
of experts, or may use an existing working group
or advisory committee, to—
(1) identify innovative research with the potential to be developed as a qualified countermeasure or a qualified pandemic or epidemic
product;
(2) identify accepted animal models for particular diseases and conditions associated with
any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research
tool development and validation; and
(3) obtain advice regarding supporting and
facilitating advanced research and development related to qualified countermeasures and
qualified pandemic or epidemic products that
are likely to be safe and effective with respect
to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect
such populations.
(c) Definitions
Any term that is defined in section 247d–7e of
this title and that is used in this section shall
have the same meaning in this section as such
term is given in section 247d–7e of this title.
(d) Authorization of appropriations
There are authorized to be appropriated
$1,000,000 to carry out this section for fiscal year
2007 and each fiscal year thereafter.
(July 1, 1944, ch. 373, title III, § 319M, as added
Pub. L. 109–417, title IV, § 402, Dec. 19, 2006, 120
Stat. 2872.)
§ 247d–8. Coordinated program to improve pediatric oral health
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a program to fund
innovative oral health activities that improve
the oral health of children under 6 years of age
who are eligible for services provided under a
Federal health program, to increase the utilization of dental services by such children, and to
decrease the incidence of early childhood and
baby bottle tooth decay.
(b) Grants
The Secretary shall award grants to or enter
into contracts with public or private nonprofit
schools of dentistry or accredited dental training institutions or programs, community dental
programs, and programs operated by the Indian
Health Service (including federally recognized
Indian tribes that receive medical services from
the Indian Health Service, urban Indian health
programs funded under title V of the Indian
Health Care Improvement Act [25 U.S.C. 1651 et
seq.], and tribes that contract with the Indian
Health Service pursuant to the Indian Self-De-

§ 247d–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

termination and Education Assistance Act [25
U.S.C. 450 et seq.]) to enable such schools, institutions, and programs to develop programs of
oral health promotion, to increase training of
oral health services providers in accordance
with State practice laws, or to increase the utilization of dental services by eligible children.
(c) Distribution
In awarding grants under this section, the Secretary shall, to the extent practicable, ensure an
equitable national geographic distribution of
the grants, including areas of the United States
where the incidence of early childhood caries is
highest.
(d) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $10,000,000 for each 1 the
fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 320A, as added
Pub. L. 106–310, div. A, title XVI, § 1603, Oct. 17,
2000, 114 Stat. 1151.)
REFERENCES IN TEXT
The Indian Health Care Improvement Act, referred to
in subsec. (b), is Pub. L. 94–437, Sept. 30, 1976, 90 Stat.
1400, as amended. Title V of the Act is classified generally to subchapter IV (§ 1651 et seq.) of chapter 18 of
Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables.
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (b), is Pub. L. 93–638,
Jan. 4, 1975, 88 Stat. 2203, as amended, which is classified principally to subchapter II (§ 450 et seq.) of chapter 14 of Title 25, Indians. For complete classification
of this Act to the Code, see Short Title note set out
under section 450 of Title 25 and Tables.
CODIFICATION
Section 1603 of Pub. L. 106–310, which directed that
section 320A (this section) be added at the end of part
B of the Public Health Service Act, was executed by
adding section 320A at the end of part B of title III of
the Public Health Service Act, to reflect the probable
intent of Congress, notwithstanding that section 320 of
the Public Health Service Act (section 247e of this
title) appears in part C of title III of the Public Health
Service Act.

§ 247d–9. Dental education for parents of newborns
The Secretary shall develop and implement,
through entities that fund or provide perinatal
care services to targeted low-income children
under a State child health plan under title XXI
of the Social Security Act [42 U.S.C. 1397aa et
seq.], a program to deliver oral health educational materials that inform new parents
about risks for, and prevention of, early childhood caries and the need for a dental visit within their newborn’s first year of life.
(Pub. L. 111–3, title V, § 501(c), Feb. 4, 2009, 123
Stat. 87.)
REFERENCES IN TEXT
The Social Security Act, referred to in text, is act
Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XXI of the Act
is classified generally to subchapter XXI (§ 1397aa et
seq.) of chapter 7 of this title. For complete classifica1 So

in original. Probably should be followed by ‘‘of’’.

Page 242

tion of this Act to the Code, see section 1305 of this
title and Tables.
CODIFICATION
Section was enacted as part of the Children’s Health
Insurance Program Reauthorization Act of 2009, and
not as part of the Public Health Service Act which
comprises this chapter.
EFFECTIVE DATE
Section effective Apr. 1, 2009, and applicable to child
health assistance and medical assistance provided on or
after that date, with certain exceptions, see section 3 of
Pub. L. 111–3, set out as a note under section 1396 of
this title.
DEFINITION OF ‘‘SECRETARY’’
‘‘Secretary’’ as meaning the Secretary of Health and
Human Services, see section 1(c)(3) of Pub. L. 111–3, set
out as a note under section 1396 of this title.

PART C—HOSPITALS, MEDICAL EXAMINATIONS,
AND MEDICAL CARE
AMENDMENTS
1978—Pub. L. 95–626, title I, § 113(a)(1), Nov. 10, 1978, 92
Stat. 3562, struck out heading ‘‘Subpart I—General Provisions’’.
1976—Pub. L. 94–484, title IV, § 407(a), Oct. 12, 1976, 90
Stat. 2268, added heading ‘‘Subpart I—General Provisions’’.

§ 247e. National Hansen’s Disease Programs Center
(a) Care and treatment
(1) At or through the National Hansen’s Disease Programs Center (located in the State of
Louisiana), the Secretary shall without charge
provide short-term care and treatment, including outpatient care, for Hansen’s disease and related complications to any person determined
by the Secretary to be in need of such care and
treatment. The Secretary may not at or through
such Center provide long-term care for any such
disease or complication.
(2) The Center referred to in paragraph (1)
shall conduct training in the diagnosis and management of Hansen’s disease and related complications, and shall conduct and promote the
coordination of research (including clinical research), investigations, demonstrations, and
studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen’s disease and other mycobacterial diseases and complications related to such diseases.
(3) Paragraph (1) is subject to section 211 of
the Department of Health and Human Services
Appropriations Act, 1998.
(b) Additional sites authorized
In addition to the Center referred to in subsection (a) of this section, the Secretary may establish sites regarding persons with Hansen’s
disease. Each such site shall provide for the outpatient care and treatment for Hansen’s disease
and related complications to any person determined by the Secretary to be in need of such
care and treatment.
(c) Agency designated by Secretary
The Secretary shall carry out subsections (a)
and (b) of this section acting through an agency
of the Service. For purposes of the preceding

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

sentence, the agency designated by the Secretary shall carry out both activities relating to
the provision of health services and activities
relating to the conduct of research.
(d) Payments to Board of Health of Hawaii
The Secretary shall make payments to the
Board of Health of the State of Hawaii for the
care and treatment (including outpatient care)
in its facilities of persons suffering from Hansen’s disease at a rate determined by the Secretary. The rate shall be approximately equal to
the operating cost per patient of such facilities,
except that the rate may not exceed the comparable costs per patient with Hansen’s disease
for care and treatment provided by the Center
referred to in subsection (a) of this section. Payments under this subsection are subject to the
availability of appropriations for such purpose.
(July 1, 1944, ch. 373, title III, § 320, formerly
§ 331, 58 Stat. 698; June 25, 1948, ch. 654, § 4, 62
Stat. 1018; June 25, 1952, ch. 460, 66 Stat. 157; Pub.
L. 86–624, § 29(b), July 12, 1960, 74 Stat. 419; renumbered § 339, Pub. L. 94–484, title IV,
§ 407(b)(2), Oct. 12, 1976, 90 Stat. 2268; renumbered
§ 320, and amended Pub. L. 95–626, title I, § 105(a),
Nov. 10, 1978, 92 Stat. 3560; Pub. L. 96–32, § 7(b),
July 10, 1979, 93 Stat. 84; Pub. L. 99–117, § 2(a),
Oct. 7, 1985, 99 Stat. 491; Pub. L. 105–78, title II,
§ 211(h), Nov. 13, 1997, 111 Stat. 1494; Pub. L.
107–220, § 1(a), Aug. 21, 2002, 116 Stat. 1332.)
REFERENCES IN TEXT
Section 211 of the Department of Health and Human
Services Appropriations Act, 1998, referred to in subsec.
(a)(3), is section 211 of Pub. L. 105–78, which enacted
this section and provisions set out as notes below.
CODIFICATION
Section was classified to section 255 of this title prior
to its renumbering by Pub. L. 95–626.
AMENDMENTS
2002—Subsec. (a)(1). Pub. L. 107–220 substituted ‘‘National Hansen’s Disease Programs Center’’ for ‘‘Gillis
W. Long Hansen’s Disease Center’’.
1997—Pub. L. 105–78 amended section catchline and
text generally, substituting present provisions for
former provisions which related to: in subsec. (a), care
and treatment; and in subsec. (b), payments to Board of
Health of Hawaii.
1985—Pub. L. 99–117 substituted ‘‘Hansen’s disease
program’’ for ‘‘Receipt, apprehension, detention, treatment, and release of lepers’’ in section catchline.
Subsec. (a). Pub. L. 99–117 amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows:
‘‘The Service shall, in accordance with regulations, receive into any hospital of the Service suitable for his
accommodation any person afflicted with leprosy who
presents himself for care, detention, or treatment, or
who may be apprehended under subsection (b) of this
section or section 264 of this title, and any person afflicted with leprosy duly consigned to the care of the
Service by the proper health authority of any State.
The Surgeon General is authorized, upon the request of
any health authority, to send for any person within the
jurisdiction of such authority who is afflicted with leprosy and to convey such person to the appropriate hospital for detention and treatment. When the transportation of any such person is undertaken for the protection of the public health the expense of such removal
shall be met from funds available for the maintenance
of hospitals of the Service. Such funds shall also be
available, subject to regulations, for transportation of
recovered indigent leper patients to their homes, in-

§ 247e

cluding subsistence allowance while traveling. When so
provided in appropriations available for any fiscal year
for the maintenance of hospitals of the Service, the
Surgeon General is authorized and directed to make
payments to the Board of Health of Hawaii for the care
and treatment in its facilities of persons afflicted with
leprosy at a per diem rate, determined from time to
time by the Surgeon General, which shall, subject to
the availability of appropriations, be approximately
equal to the per diem operating cost per patient of such
facilities, except that such per diem rate shall not be
greater than the comparable per diem operating cost
per patient at the National Leprosarium, Carville, Louisiana.’’
Subsec. (b). Pub. L. 99–117 amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows:
‘‘The Surgeon General may provide by regulation for
the apprehension, detention, treatment, and release of
persons being treated by the Service for leprosy.’’
1979—Subsec. (a). Pub. L. 96–32 substituted ‘‘apprehended under subsection (b) of this section or section
264 of this title’’ for ‘‘apprehended under section 256 or
264 of this title’’.
1978—Pub. L. 95–626 designated existing provisions as
subsec. (a) and added subsec. (b).
1960—Pub. L. 86–624 struck out ‘‘, Territory, or the
District of Columbia’’ after ‘‘proper health authority of
any State’’, and substituted ‘‘Board of Health of Hawaii’’ for ‘‘Board of Health of the Territory of Hawaii’’.
1952—Act June 25, 1952, provided for payments to Hawaiian Board of Health for expenditures made by them
in care and treatment of patients.
1948—Act June 25, 1948, authorized payment of travel
expenses of indigent leper patients.
CHANGE OF NAME
Pub. L. 107–220, §§ 1(b), 2, Aug. 21, 2002, 116 Stat. 1332,
provided that:
‘‘(b) PUBLIC LAW 105–78.—References in section 211 of
Public Law 105–78 [amending this section and enacting
provisions set out as a note under this section], and in
deeds, agreements, or other documents under such section, to the Gillis W. Long Hansen’s Disease Center
shall be deemed to be references to the National Hansen’s Disease Programs Center.
‘‘SEC. 2. OTHER REFERENCES.
‘‘Any reference in a law, map, regulation, document,
paper, or other record of the United States to the Gillis
W. Long Hansen’s Disease Center shall be deemed to be
a reference to the ‘National Hansen’s Disease Programs
Center’ ’’.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86–624 effective Aug. 21, 1959,
see section 47(f) of Pub. L. 86–624, set out as a note
under section 201 of this title.
RELOCATION OF NATIONAL HANSEN’S DISEASE
PROGRAMS CENTER
Pub. L. 105–78, title II, § 211(a)–(g), Nov. 13, 1997, 111
Stat. 1489, as amended by Pub. L. 107–220, § 1(b), Aug. 21,
2002, 116 Stat. 1332, provided that:
‘‘(a) The Secretary of Health and Human Services
may in accordance with this section provide for the relocation of the Federal facility known as the National
Hansen’s Disease Programs Center (located in the vicinity of Carville, in the State of Louisiana), including
the relocation of the patients of the Center.
‘‘(b)(1) Subject to paragraph (2), in relocating the
Center the Secretary may on behalf of the United
States transfer to the State of Louisiana, without
charge, title to the real property and improvements
that as of the date of the enactment of this Act [Nov.
13, 1997] constitute the Center. Such real property is a
parcel consisting of approximately 330 acres. The exact
acreage and legal description used for purposes of the
transfer shall be in accordance with a survey satisfactory to the Secretary.

§ 247e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) Any conveyance under paragraph (1) is not effective unless the deed or other instrument of conveyance
contains the conditions specified in subsection (d); the
instrument specifies that the United States and the
State of Louisiana agree to such conditions; and the instrument specifies that, if the State engages in a material breach of the conditions, title to the real property
and improvements involved reverts to the United
States at the election of the Secretary.
‘‘(c)(1) With respect to Federal equipment and other
items of Federal personal property that are in use at
the Center as of the date of the enactment of this Act
[Nov. 13, 1997], the Secretary may, subject to paragraph
(2), transfer to the State such items as the Secretary
determines to be appropriate, if the Secretary makes
the transfer under subsection (b).
‘‘(2) A transfer of equipment or other items may be
made under paragraph (1) only if the State agrees that,
during the 30-year period beginning on the date on
which the transfer under subsection (b) is made, the
items will be used exclusively for purposes that promote the health or education of the public, except that
the Secretary may authorize such exceptions as the
Secretary determines to be appropriate.
‘‘(d) For purposes of subsection (b)(2), the conditions
specified in this subsection with respect to a transfer of
title are the following:
‘‘(1) During the 30-year period beginning on the date
on which the transfer is made, the real property and
improvements referred to in subsection (b)(1) (referred to in this subsection as the ‘transferred property’) will be used exclusively for purposes that promote the health or education of the public, with such
incidental exceptions as the Secretary may approve.
‘‘(2) For purposes of monitoring the extent to which
the transferred property is being used in accordance
with paragraph (1), the Secretary will have access to
such documents as the Secretary determines to be
necessary, and the Secretary may require the advance approval of the Secretary for such contracts,
conveyances of real or personal property, or other
transactions as the Secretary determines to be necessary.
‘‘(3) The relocation of patients from the transferred
property will be completed not later than 3 years
after the date on which the transfer is made, except
to the extent the Secretary determines that relocating particular patients is not feasible. During the period of relocation, the Secretary will have unrestricted access to the transferred property, and after
such period will have such access as may be necessary
with respect to the patients who pursuant to the preceding sentence are not relocated.
‘‘(4)(A) With respect to projects to make repairs and
energy-related improvements at the transferred property, the Secretary will provide for the completion of
all such projects for which contracts have been
awarded and appropriations have been made as of the
date on which the transfer is made.
‘‘(B) If upon completion of the projects referred to
in subparagraph (A) there are any unobligated balances of amounts appropriated for the projects, and
the sum of such balances is in excess of $100,000—
‘‘(i) the Secretary will transfer the amount of
such excess to the State; and
‘‘(ii) the State will expend such amount for the
purposes referred to in paragraph (1), which may include the renovation of facilities at the transferred
property.
‘‘(5)(A) The State will maintain the cemetery located on the transferred property, will permit individuals who were long-term-care patients of the Center to be buried at the cemetery, and will permit
members of the public to visit the cemetery.
‘‘(B) The State will permit the Center to maintain
a museum on the transferred property, and will permit members of the public to visit the museum.
‘‘(C) In the case of any waste products stored at the
transferred property as of the date of the transfer,
the Federal Government will after the transfer retain

Page 244

title to and responsibility for the products, and the
State will not require that the Federal Government
remove the products from the transferred property.
‘‘(6) In the case of each individual who as of the
date of the enactment of this Act [Nov. 13, 1997] is a
Federal employee at the transferred property with facilities management or dietary duties:
‘‘(A) The State will offer the individual an employment position with the State, the position with
the State will have duties similar to the duties the
individual performed in his or her most recent position at the transferred property, and the position
with the State will provide compensation and benefits that are similar to the compensation and benefits provided for such most recent position, subject
to the concurrence of the Governor of the State.
‘‘(B) If the individual becomes an employee of the
State pursuant to subparagraph (A), the State will
make payments in accordance with subsection
(e)(2)(B) (relating to disability), as applicable with
respect to the individual.
‘‘(7) The Federal Government may, consistent with
the intended uses by the State of the transferred
property, carry out at such property activities regarding at-risk youth.
‘‘(8) Such additional conditions as the Secretary determines to be necessary to protect the interests of
the United States.
‘‘(e)(1) This subsection applies if the transfer under
subsection (b) is made.
‘‘(2) In the case of each individual who as of the date
of the enactment of this Act [Nov. 13, 1997] is a Federal
employee at the Center with facilities management or
dietary duties, and who becomes an employee of the
State pursuant to subsection (d)(6)(A):
‘‘(A) The provisions of subchapter III of chapter 83
of title 5, United States Code, or of chapter 84 of such
title, whichever are applicable, that relate to disability shall be considered to remain in effect with respect to the individual (subject to subparagraph (C))
until the earlier of—
‘‘(i) the expiration of the 2-year period beginning
on the date on which the transfer under subsection
(b) is made; or
‘‘(ii) the date on which the individual first meets
all conditions for coverage under a State program
for payments during retirement by reason of disability.
‘‘(B) The payments to be made by the State pursuant to subsection (d)(6)(B) with respect to the individual are payments to the Civil Service Retirement and
Disability Fund, if the individual is receiving Federal
disability coverage pursuant to subparagraph (A).
Such payments are to be made in a total amount
equal to that portion of the normal-cost percentage
(determined through the use of dynamic assumptions)
of the basic pay of the individual that is allocable to
such coverage and is paid for service performed during the period for which such coverage is in effect.
Such amount is to be determined in accordance with
chapter 84 of such title 5, is to be paid at such time
and in such manner as mutually agreed by the State
and the Office of Personnel Management, and is in
lieu of individual or agency contributions otherwise
required.
‘‘(C) In the determination pursuant to subparagraph (A) of whether the individual is eligible for
Federal disability coverage (during the applicable period of time under such subparagraph), service as an
employee of the State after the date of the transfer
under subsection (b) shall be counted toward the service requirement specified in the first sentence of section 8337(a) or 8451(a)(1)(A) of such title 5 (whichever
is applicable).
‘‘(3) In the case of each individual who as of the date
of the enactment of this Act is a Federal employee with
a position at the Center and is, for duty at the Center,
receiving the pay differential under section 208(e) of the
Public Health Service Act [section 210(e) of this title]
or under section 5545(d) of title 5, United States Code:

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(A) If as of the date of the transfer under subsection (b) the individual is eligible for an annuity
under section 8336 or 8412 of title 5, United States
Code, then once the individual separates from the
service and thereby becomes entitled to receive the
annuity, the pay differential shall be included in the
computation of the annuity if the individual separated from the service not later than the expiration
of the 90-day period beginning on the date of the
transfer.
‘‘(B) If the individual is not eligible for such an annuity as of the date of the transfer under subsection
(b) but subsequently does become eligible, then once
the individual separates from the service and thereby
becomes entitled to receive the annuity, the pay differential shall be included in the computation of the
annuity if the individual separated from the service
not later than the expiration of the 90-day period beginning on the date on which the individual first became eligible for the annuity.
‘‘(C) For purposes of this paragraph, the individual
is eligible for the annuity if the individual meets all
conditions under such section 8336 or 8412 to be entitled to the annuity, except the condition that the individual be separated from the service.
‘‘(4) With respect to individuals who as of the date of
the enactment of this Act are Federal employees with
positions at the Center and are not, for duty at the center, receiving the pay differential under section 208(e)
of the Public Health Service Act [section 210(e) of this
title] or under section 5545(d) of title 5, United States
Code:
‘‘(A) During the calendar years 1997 and 1998, the
Secretary may in accordance with this paragraph
provide to any such individual a voluntary separation
incentive payment. The purpose of such payments is
to avoid or minimize the need for involuntary separations under a reduction in force with respect to the
Center.
‘‘(B) During calendar year 1997, any payment under
subparagraph (A) shall be made under section 663 of
the Treasury, Postal Service, and General Government Appropriations Act, 1997 (as contained in section 101(f) of division A of Public Law 104–208) [5
U.S.C. 5597 note], except that, for purposes of this
subparagraph, subsection (b) of such section 663 does
not apply.
‘‘(C) During calendar year 1998, such section 663 applies with respect to payments under subparagraph
(A) to the same extent and in the same manner as
such section applied with respect to the payments
during fiscal year 1997, and for purposes of this subparagraph, the reference in subsection (c)(2)(D) of
such section 663 to December 31, 1997, is deemed to be
a reference to December 31, 1998.
‘‘(f) The following provisions apply if under subsection (a) the Secretary makes the decision to relocate the Center:
‘‘(1) The site to which the Center is relocated shall
be in the vicinity of Baton Rouge, in the State of
Louisiana.
‘‘(2) The facility involved shall continue to be designated as the National Hansen’s Disease Programs
Center.
‘‘(3) The Secretary shall make reasonable efforts to
inform the patients of the Center with respect to the
planning and carrying out of the relocation.
‘‘(4) In the case of each individual who as of October
1, 1996, was a patient of the Center and is considered
by the Director of the Center to be a long-term-care
patient (referred to in this subsection as an ‘eligible
patient’), the Secretary shall continue to provide for
the long-term care of the eligible patient, without
charge, for the remainder of the life of the patient.
‘‘(5)(A) For purposes of paragraph (4), an eligible patient who is legally competent has the following options with respect to support and maintenance and
other nonmedical expenses:
‘‘(i) For the remainder of his or her life, the patient may reside at the Center.

§ 247e

‘‘(ii) For the remainder of his or her life, the patient may receive payments each year at an annual
rate of $33,000 (adjusted in accordance with subparagraphs (C) and (D)), and may not reside at the Center. Payments under this clause are in complete
discharge of the obligation of the Federal Government under paragraph (4) for support and maintenance and other nonmedical expenses of the patient.
‘‘(B) The choice by an eligible patient of the option
under clause (i) of subparagraph (A) may at any time
be revoked by the patient, and the patient may instead choose the option under clause (ii) of such subparagraph. The choice by an eligible patient of the
option under such clause (ii) is irrevocable.
‘‘(C) Payments under subparagraph (A)(ii) shall be
made on a monthly basis, and shall be pro rated as
applicable. In 1999 and each subsequent year, the
monthly amount of such payments shall be increased
by a percentage equal to any percentage increase taking effect under section 215(i) of the Social Security
Act [section 415(i) of this title] (relating to a cost-ofliving increase) for benefits under title II of such Act
[section 401 et seq. of this title] (relating to Federal
old-age, survivors, and disability insurance benefits).
Any such percentage increase in monthly payments
under subparagraph (A)(ii) shall take effect in the
same month as the percentage increase under such
section 215(i) takes effect.
‘‘(D) With respect to the provision of outpatient
and inpatient medical care for Hansen’s disease and
related complications to an eligible patient:
‘‘(i) The choice the patient makes under subparagraph (A) does not affect the responsibility of the
Secretary for providing to the patient such care at
or through the Center.
‘‘(ii) If the patient chooses the option under subparagraph (A)(ii) and receives inpatient care at or
through the Center, the Secretary may reduce the
amount of payments under such subparagraph, except to the extent that reimbursement for the expenses of such care is available to the provider of
the care through the program under title XVIII of
the Social Security Act [section 1395 et seq. of this
title] or the program under title XIX of such Act
[section 1396 et seq. of this title]. Any such reduction shall be made on the basis of the number of
days for which the patient received the inpatient
care.
‘‘(6) The Secretary shall provide to each eligible patient such information and time as may be necessary
for the patient to make an informed decision regarding the options under paragraph (5)(A).
‘‘(7) After the date of the enactment of this Act
[Nov. 13, 1997], the Center may not provide long-term
care for any individual who as of such date was not
receiving such care as a patient of the Center.
‘‘(8) If upon completion of the projects referred to
in subsection (d)(4)(A) there are unobligated balances
of amounts appropriated for the projects, such balances are available to the Secretary for expenses relating to the relocation of the Center, except that, if
the sum of such balances is in excess of $100,000, such
excess is available to the State in accordance with
subsection (d)(4)(B). The amounts available to the
Secretary pursuant to the preceding sentence are
available until expended.
‘‘(g) For purposes of this section:
‘‘(1) The term ‘Center’ means the National Hansen’s
Disease Programs Center.
‘‘(2) The term ‘Secretary’ means the Secretary of
Health and Human Services.
‘‘(3) The term ‘State’ means the State of Louisiana.’’

§ 248

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 248. Control and management of hospitals; furnishing prosthetic and orthopedic devices;
transfer of patients; disposal of articles produced by patients; disposal of money and effects of deceased patients; payment of burial
expenses
The Surgeon General, pursuant to regulations,
shall—
(a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and maintenance, and provide for the care, treatment, and hospitalization
of patients, including the furnishing of prosthetic and orthopedic devices; and from time to
time, with the approval of the President, select
suitable sites for and establish such additional
institutions, hospitals, and stations in the
States and possessions of the United States as in
his judgment are necessary to enable the Service to discharge its functions and duties;
(b) Provide for the transfer of Public Health
Service patients, in the care of attendants where
necessary, between hospitals and stations operated by the Service or between such hospitals
and stations and other hospitals and stations in
which Public Health Service patients may be received, and the payment of expenses of such
transfer;
(c) Provide for the disposal of articles produced by patients in the course of their curative
treatment, either by allowing the patient to retain such articles or by selling them and depositing the money received therefor to the credit
of the appropriation from which the materials
for making the articles were purchased;
(d) Provide for the disposal of money and effects, in the custody of the hospitals or stations,
of deceased patients; and
(e) Provide, to the extent the Surgeon General
determines that other public or private funds
are not available therefor, for the payment of
expenses of preparing and transporting the remains of, or the payment of reasonable burial
expenses for, any patient dying in a hospital or
station.
(July 1, 1944, ch. 373, title III, § 321, 58 Stat. 695;
June 25, 1948, ch. 654, § 2, 62 Stat. 1017; Pub. L.
95–622, title II, § 266, Nov. 9, 1978, 92 Stat. 3437.)
AMENDMENTS
1978—Subsec. (a). Pub. L. 95–622 struck out ‘‘, and tobacco’’ after ‘‘orthopedic devices’’.
1948—Subsec. (a). Act June 25, 1948, § 2(a), amended
subsec. (a) generally, continuing authority of Service
to furnish tobacco to patients being treated by it.
Subsec. (e). Act June 25, 1948, § 2(b), added subsec. (e).
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health and Human Services, see Ex. Ord. No. 11140, Jan.

Page 246

30, 1964, 29 F.R. 1637, as amended, set out as a note
under section 202 of this title.

§ 248a. Closing or transfer of hospitals; reduction
of services; Congressional authorization required
(a) Except as provided in subsection (b) of this
section, the Secretary of Health and Human
Services shall take such action as may be necessary to assure that the hospitals of the Public
Health Service, located in Seattle, Washington,
Boston, Massachusetts, San Francisco, California, Galveston, Texas, New Orleans, Louisiana,
Baltimore, Maryland, Staten Island, New York,
and Norfolk, Virginia, shall continue—
(1) in operation as hospitals of the Public
Health Service,
(2) to provide for all categories of individuals
entitled or authorized to receive care and
treatment at hospitals or other stations of the
Public Health Service inpatient, outpatient,
and other health care services in like manner
as such services were provided on January 1,
1973, to such categories of individuals at the
hospitals of the Public Health Service referred
to in the matter preceding paragraph (1) and
at a level and range at least as great as the
level and range of such services which were
provided (or authorized to be provided) by
such hospitals on such date, and
(3) to conduct at such hospitals a level and
range of other health-related activities (including training and research activities) which
is not less than the level and range of such activities which were being conducted on January 1, 1973, at such hospitals.
(b)(1) The Secretary may—
(A) close or transfer control of a hospital of
the Public Health Service to which subsection
(a) of this section applies,
(B) reduce the level and range of health care
services provided at such a hospital from the
level and range required by subsection (a)(2) of
this section or change the manner in which
such services are provided at such a hospital
from the manner required by such subsection,
or
(C) reduce the level and range of the other
health-related activities conducted at such
hospital from the level and range required by
subsection (a)(3) of this section,
if Congress by law (enacted after November 16,
1973) specifically authorizes such action.
(2) Any recommendation submitted to the
Congress for legislation to authorize an action
described in paragraph (1) with respect to a hospital of the Public Health Service shall be accompanied by a copy of the written, unqualified
approval of the proposed action submitted to the
Secretary by each (A) section 314(a) State health
planning agency whose section 314(a) plan covers
(in whole or in part) the area in which such hospital is located or which is served by such hospital, and (B) section 314(b) areawide health
planning agency whose section 314(b) plan covers
(in whole or in part) such area.
(3) For purposes of this subsection, the term
‘‘section 314(a) State health planning agency’’
means the agency of a State which administers
or supervises the administration of a State’s

Page 247

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health planning functions under a State plan approved under section 314(a) of the Public Health
Service Act (referred to in paragraph (2) as a
‘‘section 314(a) plan’’); and the term ‘‘section
314(b) areawide health planning agency’’ means
a public or nonprofit private agency or organization which has developed a comprehensive regional, metropolitan, or other local area plan or
plans referred to in section 314(b) of that Act
(referred to in paragraph (2) as a ‘‘section 314(b)
plan’’).
(Pub. L. 93–155, title VIII, § 818(a), (b), Nov. 16,
1973, 87 Stat. 622; Pub. L. 96–88, title V, § 509(b),
Oct. 17, 1979, 93 Stat. 695.)
REFERENCES IN TEXT
Section 314 of the Public Health Service Act, referred
to in subsec. (b)(2), (3), is classified to section 246 of this
title.
CODIFICATION
Section was enacted as part of the Department of Defense Appropriation Authorization Act, 1974, and not as
part of the Public Health Service Act which comprises
this chapter.
PRIOR PROVISIONS
Provisions similar to those comprising this section
were contained in Pub. L. 92–585, § 3, Oct. 27, 1972, 86
Stat. 1292, setting out procedure to be followed in closing or transferring control of hospitals or other health
care delivery facilities of Public Health Service, prior
to repeal by Pub. L. 93–155, § 818(c).
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a) pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.

§ 248b. Transfer or financial self-sufficiency of
public health service hospitals and clinics
(a) Deadline for closure, transfer, or financial
self-sufficiency
The Secretary of Health and Human Services
(hereinafter in this subtitle referred to as the
‘‘Secretary’’) shall, in accordance with this section and notwithstanding section 248a of this
title, provide for the closure, transfer, or financial self-sufficiency of all hospitals and other
stations of the Public Health Service (hereinafter in this subtitle referred to as the ‘‘Service’’) not later than September 30, 1982.
(b) Proposals for transfer or financial self-sufficiency
Not later than July 1, 1981, the Secretary shall
notify each Service hospital and other station,
and the chief executive officer of each State and
of each locality in which such a hospital or
other station is located, that the Secretary will
accept proposals for the transfer of each such
hospital and station from the Service to a public
(including Federal) or nonprofit private entity
or for the achievement of financial self-sufficiency of each such hospital and station not
later than September 30, 1982. No such proposal
shall be considered by the Secretary if it is submitted later than September 1, 1981.
(c) Evaluation of proposals
The Secretary shall evaluate promptly each
proposal submitted under subsection (b) of this

§ 248b

section with respect to a hospital or other station and determine, not later than September
30, 1981, whether or not under such proposal the
hospital or station—
(1) will be maintained as a general health
care facility providing a range of services to
the population within its service area,
(2) will continue to make services available
to existing patient populations, and
(3) has a reasonable expectation of financial
viability and, in the case of a hospital or station that is not proposed to be transferred, of
financial self-sufficiency.
Paragraph (1) shall not apply in the case of a
proposal for the transfer of a discrete, minor,
freestanding part of a hospital or station to a
local public entity for the purpose of continuing
the provision of services to refugees.
(d) Rejection or approval of proposal
(1) If the Secretary determines that a proposal
for a hospital or other station does not meet the
standards of subsection (c) of this section or if
there is no proposal submitted under subsection
(b) of this section with respect to a hospital or
other station, the Secretary shall provide for
the closure of the hospital or station by not
later than October 31, 1981.
(2) If the Secretary determines that a proposal
for a hospital or other station meets the standards of subsection (c) of this section, the Secretary shall take such steps, within the amounts
available through appropriations, as may be
necessary and proper—
(A) to operate (or participate or assist in the
operation of) the hospital or station by the
Service until the transfer is accomplished or
financial self-sufficiency is achieved,
(B) to bring the hospital or station into compliance with applicable licensure, accreditation, and local medical practice standards, and
(C) to provide for such other legal, administrative, personnel, and financial arrangements
(including allowing payments made with respect to services provided by the hospital or
station to be made directly to that hospital or
station) as may be necessary to effect a timely
and orderly transfer of such hospital or station (including the land, building, and equipment thereof) from the Service, or for the financial self-sufficiency of the hospital or station, not later than September 30, 1982.
(e) Establishment of identifiable administrative
unit
There is established, within the Office of the
Assistant Secretary for Health of the Department of Health and Human Services, an identifiable administrative unit which shall have direct
responsibility and authority for overseeing the
activities under this section.
(f) Finding of financial self-sufficiency
For purposes of this section, a hospital or station cannot be found to be financially self-sufficient if the hospital or station is relying, in
whole or in part, on direct appropriated funds
for its continued operations.
(Pub. L. 97–35, title IX, § 987, Aug. 13, 1981, 95
Stat. 603.)

§§ 248c, 248d

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

This subtitle, referred to in subsec. (a), is subtitle J
of title IX of Pub. L. 97–35, §§ 985 to 988, Aug. 13, 1981, 95
Stat. 602, which enacted this section, amended sections
201, 249, and 254e of this title, and enacted provisions
set out as notes under this section and section 249 of
this title. For complete classification of this subtitle to
the Code, see Tables.
Section 248a of this title, referred to in subsec. (a),
was in the original ‘‘section 818 of Public Law 93–155’’,
meaning section 818 of Pub. L. 93–155, title VIII, Nov. 16,
1973, 87 Stat. 622, which enacted section 248a of this
title and repealed section 3 of Pub. L. 92–585, Oct. 27,
1972, 86 Stat. 1292.
CODIFICATION
Section was enacted as part of the Omnibus Budget
Reconciliation Act of 1981, and not as part of the Public
Health Service Act which comprises this chapter.
CONGRESSIONAL FINDINGS AND DECLARATION OF
PURPOSE
Section 985 of Pub. L. 97–35 provided that:
‘‘(a) Congress finds that—
‘‘(1) because of national budgetary considerations,
it has become necessary to terminate Federal appropriations for Public Health Service hospitals and
clinics,
‘‘(2) with proper planning and coordination, some of
these hospitals and clinics could be transferred to
State, local, or private control or become financially
self-sufficient and continue to provide effective and
efficient health care to individuals in the areas in
which they are located,
‘‘(3) a precipitous closure of these hospitals and
clinics will preclude the possibility of such orderly
transfer to entities which are willing and able to take
over operations at such facilities and will cause unnecessary and costly hardships on the patients and
staffs at such facilities and on the communities in
which the facilities are located, and
‘‘(4) it is in the national interest, consistent with
sound budgetary considerations, to assist in the orderly and prompt transfer of such operations to
State, local, or private operation or in the achievement of financial self-sufficiency where feasible.
‘‘(b) The purposes of this subtitle [enacting this section, amending sections 201, 249, and 254e of this title,
and enacting provisions set out as notes under section
249 of this title] are—
‘‘(1) to provide for the prompt and orderly closure
by October 31, 1981, of Public Health Service hospitals
and clinics which cannot reasonably be transferred to
State, local, or private operation or become financially self-sufficient and for the transfer or achievement of financial self-sufficiency by September 30,
1982, of those hospitals and clinics which can be so
transferred or which can achieve such financial selfsufficiency, and
‘‘(2) to provide for transitional assistance for merchant seamen whose entitlement to receive free care
through Public Health Service hospitals and clinics is
repealed and who are hospitalized at the end of fiscal
year 1981 and require continuing hospitalization.’’

§§ 248c, 248d. Repealed. Pub. L. 104–201, div. A,
title VII, § 727(a)(1), (2), Sept. 23, 1996, 110
Stat. 2596
Section 248c, Pub. L. 97–99, title IX, § 911, Dec. 23, 1981,
95 Stat. 1386; Pub. L. 98–94, title XII, § 1252(g), formerly
§ 1252(f), Sept. 24, 1983, 97 Stat. 699, renumbered § 1252(g),
Pub. L. 101–510, div. A, title VII, § 718(b)(1), Nov. 5, 1990,
104 Stat. 1586; Pub. L. 98–557, § 17(f)(1), Oct. 30, 1984, 98
Stat. 2868, related to continued use of former Public
Health Service facilities.
Section 248d, Pub. L. 98–94, title XII, § 1252, Sept. 24,
1983, 97 Stat. 698; Pub. L. 98–557, § 17(f)(2), Oct. 30, 1984,
98 Stat. 2868; Pub. L. 99–661, div. A, title VII, § 706, Nov.

Page 248

14, 1986, 100 Stat. 3905; Pub. L. 100–456, div. A, title VI,
§ 645, Sept. 29, 1988, 102 Stat. 1988; Pub. L. 101–510, div.
A, title VII, § 718(a), (b), Nov. 5, 1990, 104 Stat. 1586, 1587;
Pub. L. 102–25, title VII, § 705(h), Apr. 6, 1991, 105 Stat.
121; Pub. L. 103–160, div. A, title VII, § 717(a), Nov. 30,
1993, 107 Stat. 1693; Pub. L. 104–106, div. A, title VII,
§§ 721, 722, 727, title XV, § 1502(c)(8), Feb. 10, 1996, 110
Stat. 377, 380, 508, related to Public Health Service facilities providing medical care for dependents, members, and former members of uniformed services.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1997, see section 727(b) of Pub.
L. 104–201, set out in an Inclusion of Certain Designated
Providers in Uniformed Services Health Care Delivery
System note under section 1073 of Title 10, Armed
Forces.
EQUITABLE IMPLEMENTATION OF UNIFORM COST SHARING REQUIREMENTS FOR UNIFORMED SERVICES TREATMENT FACILITIES
Pub. L. 104–106, div. A, title VII, § 726, Feb. 10, 1996, 110
Stat. 379, provided that the uniform managed care benefit fee and copayment schedule developed by Secretary
of Defense for use in all managed care initiatives of
military health service system be extended to managed
care program of Uniformed Services Treatment Facility only after the later of the implementation of the
TRICARE regional program covering service area of
Facility or Oct. 1, 1996, and provided for evaluation of
such extension by Comptroller General, prior to repeal
by Pub. L. 104–201, div. A, title VII, § 727(a)(4), Sept. 23,
1996, 110 Stat. 2596.
MANAGED-CARE DELIVERY AND REIMBURSEMENT MODEL
FOR THE UNIFORMED SERVICES TREATMENT FACILITIES
Section 718(c) of Pub. L. 101–510, as amended by Pub.
L. 102–484, div. A, title VII, § 716, Oct. 23, 1992, 106 Stat.
2438; Pub. L. 103–160, div. A, title VII, § 718, Nov. 30, 1993,
107 Stat. 1694; Pub. L. 104–106, div. A, title VII, §§ 724(a),
725, Feb. 10, 1996, 110 Stat. 378, provided that not later
than Nov. 5, 1990, the Secretary of Defense was to begin
operation of a managed-care delivery and reimbursement model to continue to use Uniformed Services
Treatment Facilities in the military health services
system, prior to repeal by Pub. L. 104–201, div. A, title
VII, § 727(a)(3), Sept. 23, 1996, 110 Stat. 2596.

§ 249. Medical care and treatment of quarantined
and detained persons
(a) Persons entitled to treatment
Any person when detained in accordance with
quarantine laws, or, at the request of the Immigration and Naturalization Service, any person
detained by that Service, may be treated and
cared for by the Public Health Service.
(b) Temporary treatment in emergency cases
Persons not entitled to treatment and care at
institutions, hospitals, and stations of the Service may, in accordance with regulations of the
Surgeon General, be admitted thereto for temporary treatment and care in case of emergency.
(c) Authorization for outside treatment
Persons whose care and treatment is authorized by subsection (a) of this section may, in accordance with regulations, receive such care and
treatment at the expense of the Service from
public or private medical or hospital facilities
other than those of the Service, when authorized
by the officer in charge of the station at which
the application is made.
(July 1, 1944, ch. 373, title III, § 322, 58 Stat. 696;
June 25, 1948, ch. 654, § 3, 62 Stat. 1018; Aug. 8,

Page 249

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1956, ch. 1036, § 3, 70 Stat. 1120; Pub. L. 88–424,
Aug. 13, 1964, 78 Stat. 398; Pub. L. 90–174, § 10(c),
Dec. 5, 1967, 81 Stat. 541; Pub. L. 97–35, title IX,
§ 986(a), (b)(1), (2), Aug. 13, 1981, 95 Stat. 603.)
AMENDMENTS
1981—Subsec. (a). Pub. L. 97–35, § 986(a), (b)(2), redesignated subsec. (c) as (a). Former subsec. (a), which related to persons entitled to medical, etc., treatment and
hospitalization, was struck out.
Subsec. (b). Pub. L. 97–35, § 986(a), (b)(2), redesignated
subsec. (d) as (b). Former subsec. (b), which related to
treatment for seamen on foreign-flag vessels, was
struck out.
Subsec. (c). Pub. L. 97–35, § 986(b)(1), (2), redesignated
subsec. (e) as (c), substituted ‘‘subsection (a)’’ for ‘‘subsection (c)’’, and struck out ‘‘entitled to care and treatment under subsection (a) of this section and persons’’
after ‘‘Persons’’. Former subsec. (c) redesignated (a).
Subsecs. (d), (e). Pub. L. 97–35, § 986(b)(2), redesignated
subsecs. (d) and (e) as (b) and (c), respectively.
1967—Subsec. (a)(7). Pub. L. 90–174 substituted provision for entitlement to treatment and hospitalization
of seamen-trainees, while participating in maritime
training programs to develop or enhance their employability in maritime industry, for provision for such entitlement of employees and noncommissioned officers
in field service of Public Health Service when injured
or taken sick in line of duty.
1964—Subsec. (a)(8). Pub. L. 88–424 added par. (8).
1948—Subsec. (e). Act June 25, 1948, permitted Service
to provide for care and treatment of individuals detained in accordance with our quarantine laws.
EFFECTIVE DATE OF 1981 AMENDMENT
Section 986(c) of Pub. L. 97–35 provided that: ‘‘The
amendments and repeals made by this section [amending this section and sections 201 and 254e of this title]
shall take effect on October 1, 1981.’’
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of all other officers of Department of Justice and functions of all agencies and employees of such
Department transferred, with a few exceptions, to Attorney General, with power vested in him to authorize
their performance or the performance of any of his
functions by any of such officers, agencies, and employees, by sections 1 and 2 of Reorg. Plan No. 2 of 1950, eff.
May 24, 1950, 15 F.R. 3173, 64 Stat. 1261, which were repealed by Pub. L. 89–554, § 8(a), Sept. 6, 1966, 80 Stat. 662.
Immigration and Naturalization Service, referred to in
this section, was a bureau in Department of Justice.
ABOLITION OF IMMIGRATION AND NATURALIZATION
SERVICE AND TRANSFER OF FUNCTIONS
For abolition of Immigration and Naturalization
Service, transfer of functions, and treatment of related
references, see note set out under section 1551 of Title
8, Aliens and Nationality.
CONTINUED CARE FOR MERCHANT SEAMEN HOSPITALIZED
IN PUBLIC HEALTH SERVICE HOSPITALS
Section 988 of Pub. L. 97–35 provided that:
‘‘(a) The Secretary shall provide, by contract or other
arrangement with a Federal entity and without charge
but subject to subsection (b), for the continuation of inpatient hospital services (and outpatient services relat-

§ 250a

ed to the condition of hospitalization) to any individual
who—
‘‘(1) on September 30, 1981, is receiving inpatient
hospital services at a Public Health Service hospital
on the basis of the entitlement contained in section
322(a) of the Public Health Service Act (42 U.S.C.
249(a)), as such section was in effect on such date, for
treatment of a condition,
‘‘(2) requires continued hospitalization after such
date for treatment of that condition (or requires outpatient services related to such condition), and
‘‘(3) the Secretary determines has no other source
of inpatient hospital services available for continued
treatment of that condition.
‘‘(b) Services may not be provided under subsection
(a) to an individual after the earlier of—
‘‘(1) September 30, 1982,
‘‘(2) the end of the first 60-day consecutive period
(beginning after September 30, 1981) during the entire
period of which the individual is not an inpatient of
a hospital.
‘‘(c) Notwithstanding any other provision of law, the
head of any Federal department or agency which provides, under other authority of law and through federal
facilities, inpatient hospital services or outpatient
services, or both, is authorized to provide inpatient
hospital services (and related outpatient services) to
individuals under contract or other arrangement with
the Secretary pursuant to this section.’’
FOREIGN SEAMEN
Section 810(c), formerly § 710(c), of act July 1, 1944, as
renumbered by acts Aug. 13, 1946, ch. 958, § 5, 60 Stat.
1049; July 30, 1956, ch. 779, § 3(b), 70 Stat. 720, which gave
foreign seamen the same benefits as accorded seamen
employed on United States vessels under subsec. (a)(1)
of this section, was repealed effective Jan. 25, 1948, by
Joint Res. July 25, 1947, ch. 327, § 2(b), 61 Stat. 451.

§ 250. Medical care and treatment of Federal
prisoners
The Service shall supervise and furnish medical treatment and other necessary medical, psychiatric, and related technical and scientific
services, authorized by section 4005 of title 18, in
penal and correctional institutions of the United
States.
(July 1, 1944, ch. 373, title III, § 323, 58 Stat. 697.)
CODIFICATION
‘‘Section 4005 of title 18’’ substituted in text for ‘‘the
Act of May 13, 1930, as amended (U.S.C., 1940 edition,
title 18, secs. 751, 752)’’ on authority of act June 25, 1948,
ch. 645, 62 Stat. 684, the first section of which enacted
Title 18, Crimes and Criminal Procedure.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 250a. Transfer of appropriations
The Attorney General may transfer to the
Health Resources and Services Administration
such amounts as may be necessary for direct expenditures by that Administration for medical
relief for inmates of Federal penal and correctional institutions.

§ 251

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(Pub. L. 111–117, div. B, title II, Dec. 16, 2009, 123
Stat. 3129.)
CODIFICATION
Section was enacted as part of the appropriation act
cited as the credit to this section, and not as part of
the Public Health Service Act which comprises this
chapter.
Section was formerly classified to section 341h of
title 5 prior to the general revision and enactment of
Title 5, Government Organization and Employees, by
Pub. L. 89–554, § 1, Sept. 6, 1966, 80 Stat. 378.
PRIOR PROVISIONS
Provisions similar to those in this section were contained in the following prior appropriation acts:
Pub. L. 111–8, div. B, title II, Mar. 11, 2009, 123 Stat.
576.
Pub. L. 110–161, div. B, title II, Dec. 26, 2007, 121 Stat.
1905.
Pub. L. 109–108, title I, Nov. 22, 2005, 119 Stat. 2297.
Pub. L. 108–447, div. B, title I, Dec. 8, 2004, 118 Stat.
2860.
Pub. L. 108–199, div. B, title I, Jan. 23, 2004, 118 Stat.
53.
Pub. L. 108–7, div. B, title I, Feb. 20, 2003, 117 Stat. 58.
Pub. L. 107–77, title I, Nov. 28, 2001, 115 Stat. 757.
Pub. L. 106–553, § 1(a)(2) [title I], Dec. 21, 2000, 114 Stat.
2762, 2762A–60.
Pub. L. 106–113, div. B, § 1000(a)(1) [title I], Nov. 29,
1999, 113 Stat. 1535, 1501A–13.
Pub. L. 105–277, div. A, § 101(b) [title I], Oct. 21, 1998,
112 Stat. 2681–50, 2681–60.
Pub. L. 105–119, title I, Nov. 26, 1997, 111 Stat. 2449.
Pub. L. 104–208, div. A, title I, § 101(a) [title I], Sept.
30, 1996, 110 Stat. 3009, 3009–11.
Pub. L. 104–134, title I, § 101[(a)] [title I], Apr. 26, 1996,
110 Stat. 1321, 1321–9; renumbered title I, Pub. L. 104–140,
§ 1(a), May 2, 1996, 110 Stat. 1327.
Pub. L. 103–317, title I, Aug. 26, 1994, 108 Stat. 1732.
Pub. L. 103–121, title I, Oct. 27, 1993, 107 Stat. 1161.
Pub. L. 102–395, title I, Oct. 6, 1992, 106 Stat. 1836.
Pub. L. 102–140, title I, Oct. 28, 1991, 105 Stat. 790.
Pub. L. 101–515, title II, Nov. 5, 1990, 104 Stat. 2114.
Pub. L. 101–162, title II, Nov. 21, 1989, 103 Stat. 1000.
Pub. L. 100–459, title II, Oct. 1, 1988, 102 Stat. 2196.
Pub. L. 100–202, § 101(a) [title II], Dec. 22, 1987, 101
Stat. 1329, 1329–13.
Pub. L. 99–500, § 101(b) [title II], Oct. 18, 1986, 100 Stat.
1783–39, 1783–49, and Pub. L. 99–591, § 101(b) [title II], Oct.
30, 1986, 100 Stat. 3341–39, 3341–49.
Pub. L. 99–180, title II, Dec. 13, 1985, 99 Stat. 1144.
Pub. L. 98–411, title II, Aug. 30, 1984, 98 Stat. 1556.
Pub. L. 98–166, title II, Nov. 28, 1983, 97 Stat. 1084.
Pub. L. 97–377, § 101(d) [S. 2956, title II], Dec. 21, 1982,
96 Stat. 1866.
Pub. L. 97–92, § 101(h) [incorporating Pub. L. 96–536,
§ 101o; H.R. 7584, title II], Dec. 15, 1981, 95 Stat. 1190.
Pub. L. 96–536, § 101o [H.R. 7584, title II], Dec. 16, 1980,
94 Stat. 3169.
Pub. L. 96–68, title II, Sept. 24, 1979, 93 Stat. 421.
Pub. L. 95–431, title II, Oct. 10, 1978, 92 Stat. 1028.
Pub. L. 95–86, title II, Aug. 2, 1977, 91 Stat. 427.
Pub. L. 94–362, title II, July 14, 1976, 90 Stat. 945.
Pub. L. 94–121, title II, Oct. 21, 1975, 89 Stat. 620.
Pub. L. 93–433, title II, Oct. 5, 1974, 88 Stat. 1194.
Pub. L. 93–162, title II, Nov. 27, 1973, 87 Stat. 643.
Pub. L. 92–544, title II, Oct. 25, 1972, 86 Stat. 1116.
Pub. L. 92–77, title II, Aug. 10, 1971, 85 Stat. 253.
Pub. L. 91–472, title II, Oct. 21, 1970, 84 Stat. 1047.
Pub. L. 91–153, title II, Dec. 24, 1969, 83 Stat. 410.
Pub. L. 90–470, title II, Aug. 9, 1968, 82 Stat. 675.
Pub. L. 90–133, title II, Nov. 8, 1967, 81 Stat. 418.
Pub. L. 89–797, title II, Nov. 8, 1966, 80 Stat. 1487.
Pub. L. 89–164, title II, Sept. 2, 1965, 79 Stat. 628.
Pub. L. 88–527, title II, Aug. 31, 1964, 78 Stat. 719.
Pub. L. 88–245, title II, Dec. 30, 1963, 77 Stat. 783.
Pub. L. 87–843, title II, Oct. 18, 1962, 76 Stat. 1088.
Pub. L. 87–264, title II, Sept. 21, 1961, 75 Stat. 553.

Page 250

Pub. L. 86–678, title II, Aug. 31, 1960, 74 Stat. 563.
Pub. L. 86–84, title II, July 13, 1959, 73 Stat. 189.
Pub. L. 85–474, title II, June 30, 1958, 72 Stat. 252.
Pub. L. 85–49, title II, June 11, 1957, 71 Stat. 62.
June 20, 1956, ch. 414, title II, 70 Stat. 307.
July 7, 1955, ch. 279, title II, 69 Stat. 273.

§ 251. Medical examination and treatment of Federal employees; medical care at remote stations
(a) The Surgeon General is authorized to provide at institutions, hospitals, and station of the
Service medical, surgical, and hospital services
and supplies for persons entitled to treatment
under subchapter I of Chapter 81 of title 5 and
extensions thereof. The Surgeon General may
also provide for making medical examinations
of—
(1) employees of the Federal Government for
retirement purposes;
(2) employees in the Federal classified service, and applicants for appointment, as requested by the Director of the Office of Personnel Management for the purpose of promoting health and efficiency;
(3) seamen for purposes of qualifying for certificates of service; and
(4) employees eligible for benefits under the
Longshore and Harbor Workers’ Compensation
Act, as amended [33 U.S.C. 901 et seq.], as requested by any deputy commissioner thereunder.
(b) The Secretary is authorized to provide
medical, surgical, and dental treatment and hospitalization and optometric care for Federal employees (as defined in section 8901(1) of title 5)
and their dependents at remote medical facilities of the Public Health Service where such
care and treatment are not otherwise available.
Such employees and their dependents who are
not entitled to this care and treatment under
any other provision of law shall be charged for
it at rates established by the Secretary to reflect the reasonable cost of providing the care
and treatment. Any payments pursuant to the
preceding sentence shall be credited to the applicable appropriation to the Public Health
Service for the year in which such payments are
received.
(July 1, 1944, ch. 373, title III, § 324, 58 Stat. 697;
Pub. L. 90–174, § 10(a), (b), Dec. 5, 1967, 81 Stat.
540; 1978 Reorg. Plan No. 2, § 102, eff. Jan. 1, 1979,
43 F.R. 36037, 92 Stat. 3783; Pub. L. 97–468, title
VI, § 615(b)(4), Jan. 14, 1983, 96 Stat. 2578; Pub. L.
98–426, § 27(d)(2), Sept. 28, 1984, 98 Stat. 1654.)
REFERENCES IN TEXT
The Longshore and Harbor Workers’ Compensation
Act, as amended, referred to in subsec. (a)(4), is act
Mar. 4, 1927, ch. 509, 44 Stat. 1424, as amended, which is
classified generally to chapter 18 (§ 901 et seq.) of Title
33, Navigation and Navigable Waters. For complete
classification of this Act to the Code, see section 901 of
Title 33 and Tables.
CODIFICATION
In subsec. (a), ‘‘subchapter I of chapter 81 of title 5’’
substituted for ‘‘United States Employees’ Compensation Act’’ on authority of Pub. L. 89–554, § 7(b), Sept. 6,
1966, 80 Stat. 631, the first section of which enacted
Title 5, Government Organization and Employees.

Page 251

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1984—Subsec. (a)(4). Pub. L. 98–426 substituted ‘‘Longshore and Harbor Workers’ Compensation Act’’ for
‘‘Longshoremen’s and Harbor Workers’ Compensation
Act’’.
1983—Subsec. (a)(1). Pub. L. 97–468 struck out ‘‘employees of the Alaska Railroad and’’ before ‘‘employees
of the Federal Government’’.
1967—Subsec. (a). Pub. L. 90–174, § 10(a), designated existing provisions as subsec. (a) and redesignated cls. (a)
to (d) as cls. (1) to (4), respectively.
Subsec. (b). Pub. L. 90–174, § 10(b), added subsec. (b).
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98–426 effective Sept. 28, 1984,
see section 28(e)(1) of Pub. L. 98–426, set out as a note
under section 901 of Title 33, Navigation and Navigable
Waters.
EFFECTIVE DATE OF 1983 AMENDMENT
Amendment by Pub. L. 97–468 effective on date of
transfer of Alaska Railroad to the State [Jan. 5, 1985],
pursuant to section 1203 of Title 45, Railroads, see section 615(b) of Pub. L. 97–468.
TRANSFER OF FUNCTIONS
‘‘Director of the Office of Personnel Management’’
substituted for ‘‘Civil Service Commission’’ in subsec.
(a)(2), pursuant to Reorg. Plan No. 2 of 1978, § 102, 43
F.R. 36037, 92 Stat. 3783, set out under section 1101 of
Title 5, Government Organization and Employees,
which transferred all functions vested by statute in
United States Civil Service Commission to Director of
Office of Personnel Management (except as otherwise
specified), effective Jan. 1, 1979, as provided by section
1–102 of Ex. Ord. No. 12107, Dec. 28, 1978, 44 F.R. 1055, set
out under section 1101 of Title 5.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 252. Medical examination of aliens
The Surgeon General shall provide for making,
at places within the United States or in other
countries, such physical and mental examinations of aliens as are required by the immigration laws, subject to administrative regulations
prescribed by the Attorney General and medical
regulations prescribed by the Surgeon General
with the approval of the Secretary.
(July 1, 1944, ch. 373, title III, § 325, 58 Stat. 697;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631.)
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by

§ 253

section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
ABOLITION OF IMMIGRATION AND NATURALIZATION
SERVICE AND TRANSFER OF FUNCTIONS
For abolition of Immigration and Naturalization
Service, transfer of functions, and treatment of related
references, see note set out under section 1551 of Title
8, Aliens and Nationality.

§ 253. Medical services to Coast Guard, National
Oceanic and Atmospheric Administration,
and Public Health Service
(a) Persons entitled to medical services
Subject to regulations of the President—
(1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the Regular Coast Guard on active
duty, including those on shore duty and those
on detached duty; and Regular, and temporary
members of the United States Coast Guard Reserve when on active duty;
(2) commissioned officers, ships’ officers, and
members of the crews of vessels of the National Oceanic and Atmospheric Administration on active duty, including those on shore
duty and those on detached duty; and
(3) commissioned officers of the Regular or
Reserve Corps of the Public Health Service on
active duty;
shall be entitled to medical, surgical, and dental
treatment and hospitalization by the Service.
The Surgeon General may detail commissioned
officers for duty aboard vessels of the Coast
Guard or the National Oceanic and Atmospheric
Administration.
(b) Health care for involuntarily separated officers and dependents
(1) The Secretary may provide health care for
an officer of the Regular or Reserve Corps involuntarily separated from the Service, and for any
dependent of such officer, if—
(A) the officer or dependent was receiving
health care at the expense of the Service at
the time of separation; and
(B) the Secretary finds that the officer or dependent is unable to obtain appropriate insurance for the conditions for which the officer or
dependent was receiving health care.
(2) Health care may be provided under paragraph (1) for a period of not more than one year
from the date of separation of the officer from
the Service.
(c) Examination of personnel of Service assigned
to Coast Guard or National Oceanic and Atmospheric Administration
The Service shall provide all services referred
to in subsection (a) of this section required by
the Coast Guard or National Oceanic and Atmospheric Administration and shall perform all duties prescribed by statute in connection with the
examinations to determine physical or mental
condition for purposes of appointment, enlistment, and reenlistment, promotion and retire-

§ 253a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment, and officers of the Service assigned to
duty on Coast Guard or National Oceanic and
Atmospheric Administration vessels may extend
aid to the crews of American vessels engaged in
deep-sea fishing.
(July 1, 1944, ch. 373, title III, § 326, 58 Stat. 697;
June 7, 1956, ch. 374, § 306(3), 70 Stat. 254; Pub. L.
86–415, § 5(d), Apr. 8, 1960, 74 Stat. 34; Pub. L.
88–71, § 2, July 19, 1963, 77 Stat. 83; 1965 Reorg.
Plan No. 2, eff. July 13, 1965, 30 F.R. 8819, 79 Stat.
1318; 1970 Reorg. Plan No. 4, eff. Oct. 3, 1970, 35
F.R. 15627, 84 Stat. 2090; Pub. L. 99–117, § 5, Oct.
7, 1985, 99 Stat. 492.)
AMENDMENTS
1985—Subsec. (b). Pub. L. 99–117 added subsec. (b).
1963—Subsec. (b). Pub. L. 88–71, § 2(a), repealed subsec.
(b) which provided for treatment of dependents of personnel. See section 253a(b) of this title.
Subsec. (c). Pub. L. 88–71, § 2(b), inserted ‘‘or Coast
and Geodetic Survey’’ after ‘‘Coast Guard’’ in two
places.
1960—Subsec. (a). Pub. L. 86–415 struck out provisions
which authorized medical, surgical, and dental care and
hospitalization for retired personnel of Coast Guard,
Coast and Geodetic Survey, and Public Health Service.
1956—Subsec. (b). Act June 7, 1956, repealed subsec. (b)
except insofar as it related to dependent members of
families of ships’ officers and members of crews of vessels of Coast and Geodetic Survey.
CHANGE OF NAME
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services
Administration, and commissioned officers of Survey
transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff.
July 13, 1965, 30 F.R. 8819, 79 Stat. 1318, set out in the
Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 4 of 1970, eff. Oct. 3, 1970, 35
F.R. 15627, 84 Stat. 2090, abolished Environmental
Science Services Administration, established National
Oceanic and Atmospheric Administration, and redesignated Commissioned Officer Corps of ESSA as Commissioned Officer Corps of NOAA. For further details, see
Transfer of Functions note set out under section 851 of
Title 33, Navigation and Navigable Waters.
EFFECTIVE DATE OF 1956 AMENDMENT
Amendment by act June 7, 1956, effective six months
after June 7, 1956, see section 307 of act June 7, 1956.
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

Page 252

§ 253a. Medical services to retired personnel of
National Oceanic and Atmospheric Administration
(a) Eligibility
Subject to regulations of the President, retired ships’ officers and retired members of the
crews of vessels of the National Oceanic and Atmospheric Administration shall be entitled to
medical, surgical, and dental treatment and hospitalization by the Public Health Service if the
ships’ officer or crew member, (1) was on active
duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1,
1963, or on July 19, 1963, whichever is later, and
his employment as a vessel employee was continuous from that date until retirement, or (2)
was retired as a vessel employee of the National
Oceanic and Atmospheric Administration on or
before July 1, 1963, or on July 19, 1963, whichever
is later.
(b) Treatment of dependents of personnel
Subject to regulations of the President, dependent members of families (as defined in such
regulations) of ships’ officers and members of
crews of vessels of the National Oceanic and Atmospheric Administration, whether such, ships’
officers and members of crew are on active duty
or retired, shall be furnished medical advice and
outpatient treatment by the Public Health Service and, if suitable accommodations are available, they shall also be furnished hospitalization
by the Public Health Service if the ships’ officer
or crew member (1) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on
July 19, 1963, whichever is later, and his employment as a vessel employee has been continuous
from that time, or (2) was on active duty as a
vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on
July 19, 1963, whichever is later, and his employment as a vessel employee was continuous from
that time until retirement, or (3) was retired as
a vessel employee of the National Oceanic and
Atmospheric Administration on or before July 1,
1963, or on July 19, 1963, whichever is later. When
dependent members of families are hospitalized,
a per diem charge, at such uniform rate as may
be prescribed from time to time for the hospitalization of dependents of members of the
uniformed services at hospitals of the uniformed
services pursuant to section 1078(a) of title 10
shall be made.
(c) Identification
The National Oceanic and Atmospheric Administration shall furnish proper identification
to those persons entitled to medical treatment
under the provisions of this section.
(Pub. L. 88–71, § 1, July 19, 1963, 77 Stat. 83; 1965
Reorg. Plan No. 2, eff. July 13, 1965, 30 F.R. 8819,
79 Stat. 1318; 1970 Reorg. Plan No. 4, eff. Oct. 3,
1970, 35 F.R. 15627, 84 Stat. 2090; Pub. L. 98–498,
title III, § 310(b), (c), Oct. 19, 1984, 98 Stat. 2306,
2307.)
CODIFICATION
Section was not enacted as part of the Public Health
Service Act which comprises this chapter.

Page 253

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1984—Subsec. (a). Pub. L. 98–498, § 310(b), substituted
‘‘by the Public Health Service if’’ for ‘‘at facilities of
the Public Health Service: Provided, That’’.
Subsec. (b). Pub. L. 98–498, § 310(c), struck out ‘‘at its
hospitals and relief stations’’ before ‘‘and, if suitable
accommodations’’ and substituted ‘‘by the Public
Health Service if’’ for ‘‘at hospitals of the Public
Health Service: Provided, That’’.
CHANGE OF NAME
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services
Administration, and commissioned officers of Survey
transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff.
July 13, 1965, 30 F.R. 8819, 79 Stat. 1318, set out in the
Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 4 of 1970, eff. Oct. 3, 1970, 35
F.R. 15627, 84 Stat. 2090, abolished Environmental
Science Services Administration, established National
Oceanic and Atmospheric Administration, and redesignated Commissioned Officer Corps of ESSA as Commissioned Officer Corps of NOAA. For further details, see
Transfer of Functions note set out under section 851 of
Title 33, Navigation and Navigable Waters.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
EX. ORD. NO. 11160. REGULATIONS RELATING TO MEDICAL
CARE FOR RETIRED PERSONNEL OF COAST AND GEODETIC
SURVEY [NOW NATIONAL OCEANIC AND ATMOSPHERIC
ADMINISTRATION] AND THEIR DEPENDENTS
Ex. Ord. No. 11160, July 6, 1964, 29 F.R. 9315, provided:
By virtue of the authority vested in me by the first
section of the Act of July 19, 1963 (Public Law 88–71, 77
Stat. 83, 42 U.S.C. 253a) [this section], and as President
of the United States, I hereby prescribe the following
regulations relating to the medical care of certain retired personnel of the Coast and Geodetic Survey [now
National Oceanic and Atmospheric Administration]
and dependents of Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration] ships’
officers and crew members, both active and retired.
SECTION 1. Definitions. As used in these regulations,
the term:
(1) ‘‘Retired ships’ officer and retired crew member’’
means a noncommissioned ships’ officer or crew member of a vessel of the Coast and Geodetic Survey [now
National Oceanic and Atmospheric Administration]
who either was on active duty as a vessel employee on
July 19, 1963, and whose employment as such vessel employee was continuous from that date until the date of
his retirement, or who had retired as a vessel employee
on or before July 19, 1963.
(2) ‘‘Active duty ships’ officer and active duty crew
member’’ means a noncommissioned ships’ officer or
crew member on active duty as a vessel employee of
the Coast and Geodetic Survey [now National Oceanic
and Atmospheric Administration] on July 19, 1963, and
whose employment as such vessel employee has been
continuous from that time.
(3) ‘‘Dependent members of families’’, with respect to
active duty or retired ships’ officers or crew members,
means:
(A) the lawful wife;
(B) the unmarried legitimate child, including an
adopted child or stepchild, who has not passed his
twenty-first birthday; and

§ 253a

(C) the father or mother, if in fact dependent upon
such active duty or retired ships’ officer or crew member for over one-half of his or her support.
(4) ‘‘Relief stations’’ means Public Health Service
outpatient clinics and outpatient offices.
(5) ‘‘Outpatient clinic’’ means a full-time outpatient
medical facility, operated in Federally owned or leased
space under the supervision of a commissioned medical
officer or a full-time civil service medical officer (formerly known as a Second-Class Relief Station).
(6) ‘‘Outpatient office’’ means a part-time outpatient
facility serving all classes of legal beneficiaries, located in other than Federal space, and in the charge of
a local private physician under contract to the Service
to provide medical care on an annual or fee basis (formerly known as a Third-Class Relief Station).
SEC. 2. Persons entitled to treatment. The following persons shall be entitled to medical care under these regulations:
(1) Retired ships’ officers and retired crew members
of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration];
(2) Dependent members of families of persons described in paragraph (1) of this section;
(3) Dependent members of families of active duty
ships’ officers and crew members of the Coast and Geodetic Survey [now National Oceanic and Atmospheric
Administration].
SEC. 3. Application for treatment; evidence of eligibility.
Persons entitled to medical care under Section 2 of
these regulations, when applying to Public Health
Service medical care facilities for medical care, shall
produce proper identification, as issued to them by the
Coast and Geodetic Survey [now National Oceanic and
Atmospheric Administration], and such identification
shall be accepted as evidence of eligibility for such
medical care by the Service.
SEC. 4. Extent of treatment; retired ships’ officers and
crew members. Subject to the limitation imposed by
paragraph (2) of this section, retired ships’ officers and
crew members entitled to medical care under these regulations shall be furnished:
(1) Medical, surgical, and dental treatment at hospitals, outpatient clinics, and outpatient offices of the
Service, and hospitalization at hospitals of the Service.
The Service will not be responsible for defraying the
cost of hospitalization, medical services, and supplies
procured elsewhere.
(2) Dental treatment shall be furnished to the extent
that facilities and services at hospitals and outpatient
clinics of the Service having full-time dental officers
on duty are available to provide such treatment. At
other Service facilities, dental treatment shall be limited to emergency measures necessary to relieve pain.
SEC. 5. Extent of treatment; dependent members of families; charges. (a) Dependent members of families shall be
furnished medical advice and outpatient treatment at
hospitals, outpatient clinics, and outpatient offices of
the Service and, if suitable accommodations are available, shall be furnished hospitalization at hospitals of
the Service. The Service will not be responsible for defraying the cost of hospitalization, medical services,
and supplies procured elsewhere.
(b) For the purpose of this section—
(1) Medical advice and outpatient treatment may include such services and supplies as the Medical Officer
in Charge may deem to be necessary for reasonable and
adequate treatment.
(2) Hospitalization shall be furnished when, in the
opinion of the Medical Officer in Charge, suitable accommodations are available and the condition of the
patient is such as to require hospitalization. When hospitalization is authorized, it may include such services
and supplies as the Medical Officer in Charge may deem
to be necessary for reasonable and adequate treatment.
(c) Charges shall be made for hospitalization of dependent members of families at the same per diem rate
as is prescribed for dependents of members of the uniformed services pursuant to section 1078(a) of Title 10 of
the United States Code.

§ 253b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Dental treatment may be furnished to the extent
that facilities and services at hospitals and outpatient
clinics of the Service having full-time dental officers
are available to provide such treatment. Dental care
will not be furnished under any circumstances in private facilities at the expense of the Service.
SEC. 6. Prior orders. Executive Order No. 9703 of March
12, 1946, prescribing regulations relating to medical
care of certain personnel of the Coast Guard, Coast and
Geodetic Survey [now National Oceanic and Atmospheric Administration], Public Health Service, and
former Lighthouse Service, is hereby amended to the
extent necessary to conform it to the provisions of this
order.
LYNDON B. JOHNSON.

§ 253b. Former Lighthouse Service employees;
medical service eligibility
Subject to regulations of the President, lightkeepers, assistant lightkeepers, and officers and
crews of vessels of the former Lighthouse Service, including any such persons who subsequent
to June 30, 1939, were involuntarily assigned to
other civilian duty in the Coast Guard, who were
entitled to medical relief at hospitals and other
stations of the Public Health Service prior to
July 1, 1944, and who retired under the provisions of section 763 of title 33, shall be entitled
to medical, surgical, and dental treatment and
hospitalization at hospitals and other stations
of the Public Health Service.
(Pub. L. 93–353, title I, § 108(a), July 23, 1974, 88
Stat. 371.)
CODIFICATION
Section was enacted as a part of Health Services Research, Health Statistics, and Medical Libraries Act of
1974, and also as a part of Health Services Research and
Evaluation and Health Statistics Act of 1974, and not as
a part of the Public Health Service Act which comprises this chapter.
EFFECTIVE DATE
Section 108(b) of Pub. L. 93–353 provided that: ‘‘Subsection (a) [enacting this section] shall be effective
from December 28, 1973.’’
TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.

§ 254. Interdepartmental work
Nothing contained in this part shall affect the
authority of the Service to furnish any materials, supplies, or equipment, or perform any
work of services, requested in accordance with
sections 1535 and 1536 of title 31, or the authority
of any other executive department to furnish
any materials, supplies, or equipment, or perform any work or services, requested by the Department of Health and Human Services for the
Service in accordance with that section.
(July 1, 1944, ch. 373, title III, § 327, 58 Stat. 697;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695.)

Page 254

CODIFICATION
‘‘Sections 1535 and 1536 of title 31’’ substituted in text
for ‘‘section 7 of the Act of May 21, 1920, as amended
(U.S.C., 1940 edition, title 31, sec. 686)’’ on authority of
Pub. L. 97–258, § 4(b), Sept. 13, 1982, 96 Stat. 1067, the
first section of which enacted Title 31, Money and Finance.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 254a. Sharing of medical care facilities and resources
(a) Definitions
For purposes of this section—
(1) the term ‘‘specialized health resources’’
means health care resources (whether equipment, space, or personnel) which, because of
cost, limited availability, or unusual nature,
are either unique in the health care community or are subject to maximum utilization
only through mutual use;
(2) the term ‘‘hospital’’, unless otherwise
specified, includes (in addition to other hospitals) any Federal hospital.
(b) Statement of purpose; agreements or arrangements;
reciprocity;
reimbursement;
credits
For the purpose of maintaining or improving
the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities
and hospitals and other health facilities in the
health care community, and to promote the full
utilization of hospitals and other health facilities and resources, the Secretary may—
(1) enter into agreements or arrangements
with schools of medicine, schools of osteopathic medicine, and with other health professions schools, agencies, or institutions, for
such interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the training
or research programs of the participating
agencies; and
(2) enter into agreements or arrangements
with hospitals and other health care facilities
for the mutual use or the exchange of use of

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specialized health resources, and providing for
reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement shall be based on charges
covering the reasonable cost of such utilization,
including normal depreciation and amortization
costs of equipment. Any proceeds to the Government under this subsection shall be credited to
the applicable appropriation of the Public
Health Service for the year in which such proceeds are received.
(July 1, 1944, ch. 373, title III, § 327A, formerly
§ 328, as added Pub. L. 90–174, § 7, Dec. 5, 1967, 81
Stat. 539; renumbered § 327A, Pub. L. 95–626, title
I, § 113(a)(2), Nov. 10, 1978, 92 Stat. 3562; amended
Pub. L. 100–607, title VI, § 629(a)(1), Nov. 4, 1988,
102 Stat. 3146.)
AMENDMENTS
1988—Subsec. (b)(1). Pub. L. 100–607 inserted ‘‘schools
of osteopathic medicine,’’ after ‘‘schools of medicine,’’
and ‘‘professions’’ after ‘‘health’’.
AVAILABILITY OF APPROPRIATIONS FOR EXPENSES OF
SHARING MEDICAL CARE FACILITIES AND RESOURCES
Pub. L. 102–394, title II, § 204, Oct. 6, 1992, 106 Stat.
1811, provided that: ‘‘Funds advanced to the National
Institutes of Health Management Fund from appropriations in this Act or subsequent Departments of Labor,
Health and Human Services, and Education, and Related Agencies Appropriations Acts shall be available for
the expenses of sharing medical care facilities and resources pursuant to section 327A of the Public Health
Service Act [42 U.S.C. 254a].’’
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 102–170, title II, § 204, Nov. 26, 1991, 105 Stat.
1126.
Pub. L. 101–517, title II, § 204, Nov. 5, 1990, 104 Stat.
2208.
Pub. L. 101–166, title II, § 205, Nov. 21, 1989, 103 Stat.
1177.
Pub. L. 100–202, § 101(h) [title II, § 205], Dec. 22, 1987, 101
Stat. 1329–256, 1329–274.
Pub. L. 99–500, § 101(i) [H.R. 5233, title II, § 205], Oct. 18,
1986, 100 Stat. 1783–287, and Pub. L. 99–591, § 101(i) [H.R.
5233, title II, § 205], Oct. 30, 1986, 100 Stat. 3341–287.
Pub. L. 99–178, title II, § 205, Dec. 12, 1985, 99 Stat. 1119.
Pub. L. 98–619, title II, § 205, Nov. 8, 1984, 98 Stat. 3321.
Pub. L. 98–139, title II, § 205, Oct. 31, 1983, 97 Stat. 887.
Pub. L. 97–377, title I, § 101(e)(1) [title II, § 205], Dec. 21,
1982, 96 Stat. 1878, 1894.

PART D—PRIMARY HEALTH CARE
SUBPART I—HEALTH CENTERS

AMENDMENTS
1996—Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626,
substituted ‘‘Health Centers’’ for ‘‘Primary Health Centers’’ in subpart heading.
1978—Pub. L. 95–626, title I, § 113(a)(3), Nov. 10, 1978, 92
Stat. 3562, added heading ‘‘Part D—Primary Health
Care’’ and, immediately under it, heading ‘‘Subpart I—
Primary Health Centers’’.

§ 254b. Health centers
(a) ‘‘Health center’’ defined
(1) In general
For purposes of this section, the term
‘‘health center’’ means an entity that serves a
population that is medically underserved, or a
special medically underserved population comprised of migratory and seasonal agricultural

§ 254b

workers, the homeless, and residents of public
housing, by providing, either through the staff
and supporting resources of the center or
through contracts or cooperative arrangements—
(A) required primary health services (as
defined in subsection (b)(1) of this section);
and
(B) as may be appropriate for particular
centers, additional health services (as defined in subsection (b)(2) of this section) necessary for the adequate support of the primary health services required under subparagraph (A);
for all residents of the area served by the center (hereafter referred to in this section as the
‘‘catchment area’’).
(2) Limitation
The requirement in paragraph (1) to provide
services for all residents within a catchment
area shall not apply in the case of a health
center receiving a grant only under subsection
(g), (h), or (i) of this section.
(b) Definitions
For purposes of this section:
(1) Required primary health services
(A) In general
The term ‘‘required primary health services’’ means—
(i) basic health services which, for purposes of this section, shall consist of—
(I) health services related to family
medicine, internal medicine, pediatrics,
obstetrics, or gynecology that are furnished by physicians and where appropriate, physician assistants, nurse practitioners, and nurse midwives;
(II) diagnostic laboratory and radiologic services;
(III) preventive health services, including—
(aa) prenatal and perinatal services;
(bb) appropriate cancer screening;
(cc) well-child services;
(dd) immunizations against vaccinepreventable diseases;
(ee) screenings for elevated blood
lead levels, communicable diseases,
and cholesterol;
(ff) pediatric eye, ear, and dental
screenings to determine the need for
vision and hearing correction and dental care;
(gg) voluntary family planning services; and
(hh) preventive dental services;
(IV) emergency medical services; and
(V) pharmaceutical services as may be
appropriate for particular centers;
(ii) referrals to providers of medical services (including specialty referral when
medically indicated) and other health-related services (including substance abuse
and mental health services);
(iii) patient case management services
(including counseling, referral, and followup services) and other services designed to

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

assist health center patients in establishing eligibility for and gaining access to
Federal, State, and local programs that
provide or financially support the provision of medical, social, housing, educational, or other related services;
(iv) services that enable individuals to
use the services of the health center (including outreach and transportation services and, if a substantial number of the individuals in the population served by a
center are of limited English-speaking
ability, the services of appropriate personnel fluent in the language spoken by a predominant number of such individuals); and
(v) education of patients and the general
population served by the health center regarding the availability and proper use of
health services.
(B) Exception
With respect to a health center that receives a grant only under subsection (g) of
this section, the Secretary, upon a showing
of good cause, shall—
(i) waive the requirement that the center
provide all required primary health services under this paragraph; and
(ii) approve, as appropriate, the provision of certain required primary health
services only during certain periods of the
year.
(2) Additional health services
The term ‘‘additional health services’’
means services that are not included as required primary health services and that are
appropriate to meet the health needs of the
population served by the health center involved. Such term may include—
(A) behavioral and mental health and substance abuse services;
(B) recuperative care services;
(C) environmental health services, including—
(i) the detection and alleviation of unhealthful conditions associated with—
(I) water supply;
(II) chemical and pesticide exposures;
(III) air quality; or
(IV) exposure to lead;
(ii) sewage treatment;
(iii) solid waste disposal;
(iv) rodent and parasitic infestation;
(v) field sanitation;
(vi) housing; and
(vii) other environmental factors related
to health; and
(D) in the case of health centers receiving
grants under subsection (g) of this section,
special occupation-related health services
for migratory and seasonal agricultural
workers, including—
(i) screening for and control of infectious
diseases, including parasitic diseases; and
(ii) injury prevention programs, including prevention of exposure to unsafe levels
of agricultural chemicals including pesticides.
(3) Medically underserved populations
(A) In general
The term ‘‘medically underserved population’’ means the population of an urban or

Page 256

rural area designated by the Secretary as an
area with a shortage of personal health services or a population group designated by the
Secretary as having a shortage of such services.
(B) Criteria
In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the specific shortages of personal health
services of an area or population group.
Such criteria shall—
(i) take into account comments received
by the Secretary from the chief executive
officer of a State and local officials in a
State; and
(ii) include factors indicative of the
health status of a population group or residents of an area, the ability of the residents of an area or of a population group
to pay for health services and their accessibility to them, and the availability of
health professionals to residents of an area
or to a population group.
(C) Limitation
The Secretary may not designate a medically underserved population in a State or
terminate the designation of such a population unless, prior to such designation or
termination, the Secretary provides reasonable notice and opportunity for comment
and consults with—
(i) the chief executive officer of such
State;
(ii) local officials in such State; and
(iii) the organization, if any, which represents a majority of health centers in
such State.
(D) Permissible designation
The Secretary may designate a medically
underserved population that does not meet
the criteria established under subparagraph
(B) if the chief executive officer of the State
in which such population is located and local
officials of such State recommend the designation of such population based on unusual local conditions which are a barrier to
access to or the availability of personal
health services.
(c) Planning grants
(1) In general
(A) Centers
The Secretary may make grants to public
and nonprofit private entities for projects to
plan and develop health centers which will
serve medically underserved populations. A
project for which a grant may be made under
this subsection may include the cost of the
acquisition and lease of buildings and equipment (including the costs of amortizing the
principal of, and paying the interest on,
loans) and shall include—
(i) an assessment of the need that the
population proposed to be served by the
health center for which the project is
undertaken has for required primary
health services and additional health services;
(ii) the design of a health center program
for such population based on such assessment;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iii) efforts to secure, within the proposed catchment area of such center, financial and professional assistance and
support for the project;
(iv) initiation and encouragement of continuing community involvement in the development and operation of the project;
and
(v) proposed linkages between the center
and other appropriate provider entities,
such as health departments, local hospitals, and rural health clinics, to provide
better coordinated, higher quality, and
more cost-effective health care services.
(B) Managed care networks and plans
The Secretary may make grants to health
centers that receive assistance under this
section to enable the centers to plan and develop a managed care network or plan. Such
a grant may only be made for such a center
if—
(i) the center has received grants under
subsection (e)(1)(A) of this section for at
least 2 consecutive years preceding the
year of the grant under this subparagraph
or has otherwise demonstrated, as required
by the Secretary, that such center has
been providing primary care services for at
least the 2 consecutive years immediately
preceding such year; and
(ii) the center provides assurances satisfactory to the Secretary that the provision
of such services on a prepaid basis, or
under another managed care arrangement,
will not result in the diminution of the
level or quality of health services provided
to the medically underserved population
served prior to the grant under this subparagraph.
(C) Practice management networks
The Secretary may make grants to health
centers that receive assistance under this
section to enable the centers to plan and develop practice management networks that
will enable the centers to—
(i) reduce costs associated with the provision of health care services;
(ii) improve access to, and availability
of, health care services provided to individuals served by the centers;
(iii) enhance the quality and coordination of health care services; or
(iv) improve the health status of communities.
(D) Use of funds
The activities for which a grant may be
made under subparagraph (B) or (C) may include the purchase or lease of equipment,
which may include data and information
systems (including paying for the costs of
amortizing the principal of, and paying the
interest on, loans for equipment), the provision of training and technical assistance related to the provision of health care services
on a prepaid basis or under another managed
care arrangement, and other activities that
promote the development of practice management or managed care networks and
plans.

§ 254b

(2) Limitation
Not more than two grants may be made
under this subsection for the same project, except that upon a showing of good cause, the
Secretary may make additional grant awards.
(3) Recognition of high poverty
(A) In general
In making grants under this subsection,
the Secretary may recognize the unique
needs of high poverty areas.
(B) High poverty area defined
For purposes of subparagraph (A), the term
‘‘high poverty area’’ means a catchment
area which is established in a manner that is
consistent with the factors in subsection
(k)(3)(J), and the poverty rate of which is
greater than the national average poverty
rate as determined by the Bureau of the Census.
(d) Loan guarantee program
(1) Establishment
(A) In general
The Secretary shall establish a program
under which the Secretary may, in accordance with this subsection and to the extent
that appropriations are provided in advance
for such program, guarantee up to 90 percent
of the principal and interest on loans made
by non-Federal lenders to health centers,
funded under this section, for the costs of developing and operating managed care networks or plans described in subsection
(c)(1)(B) of this section, or practice management networks described in subsection
(c)(1)(C) of this section.
(B) Use of funds
Loan funds guaranteed under this subsection may be used—
(i) to establish reserves for the furnishing of services on a pre-paid basis;
(ii) for costs incurred by the center or
centers, otherwise permitted under this
section, as the Secretary determines are
necessary to enable a center or centers to
develop, operate, and own the network or
plan; or
(iii) to refinance an existing loan (as of
the date of refinancing) to the center or
centers, if the Secretary determines—
(I) that such refinancing will be beneficial to the health center and the Federal Government; or
(II) that the center (or centers) can
demonstrate an ability to repay the refinanced loan equal to or greater than the
ability of the center (or centers) to repay
the original loan on the date the original
loan was made.
(C) Publication of guidance
Prior to considering an application submitted under this subsection, the Secretary
shall publish guidelines to provide guidance
on the implementation of this section. The
Secretary shall make such guidelines available to the universe of parties affected under
this subsection, distribute such guidelines to

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

such parties upon the request of such parties, and provide a copy of such guidelines to
the appropriate committees of Congress.
(D) Provision directly to networks or plans
At the request of health centers receiving
assistance under this section, loan guarantees provided under this paragraph may be
made directly to networks or plans that are
at least majority controlled and, as applicable, at least majority owned by those health
centers.
(E) Federal credit reform
The requirements of the Federal Credit
Reform Act of 1990 (2 U.S.C. 661 et seq.) shall
apply with respect to loans refinanced under
subparagraph (B)(iii).
(2) Protection of financial interests
(A) In general
The Secretary may not approve a loan
guarantee for a project under this subsection
unless the Secretary determines that—
(i) the terms, conditions, security (if
any), and schedule and amount of repayments with respect to the loan are sufficient to protect the financial interests of
the United States and are otherwise reasonable, including a determination that
the rate of interest does not exceed such
percent per annum on the principal obligation outstanding as the Secretary determines to be reasonable, taking into account the range of interest rates prevailing in the private market for similar loans
and the risks assumed by the United
States, except that the Secretary may not
require as security any center asset that
is, or may be, needed by the center or centers involved to provide health services;
(ii) the loan would not be available on
reasonable terms and conditions without
the guarantee under this subsection; and
(iii) amounts appropriated for the program under this subsection are sufficient
to provide loan guarantees under this subsection.
(B) Recovery of payments
(i) In general
The United States shall be entitled to recover from the applicant for a loan guarantee under this subsection the amount of
any payment made pursuant to such guarantee, unless the Secretary for good cause
waives such right of recovery (subject to
appropriations remaining available to permit such a waiver) and, upon making any
such payment, the United States shall be
subrogated to all of the rights of the recipient of the payments with respect to which
the guarantee was made. Amounts recovered under this clause shall be credited as
reimbursements to the financing account
of the program.
(ii) Modification of terms and conditions
To the extent permitted by clause (iii)
and subject to the requirements of section
504(e) of the Credit Reform Act of 1990 (2
U.S.C. 661c(e)), any terms and conditions

Page 258

applicable to a loan guarantee under this
subsection (including terms and conditions
imposed under clause (iv)) may be modified
or waived by the Secretary to the extent
the Secretary determines it to be consistent with the financial interest of the
United States.
(iii) Incontestability
Any loan guarantee made by the Secretary under this subsection shall be incontestable—
(I) in the hands of an applicant on
whose behalf such guarantee is made unless the applicant engaged in fraud or
misrepresentation in securing such guarantee; and
(II) as to any person (or successor in
interest) who makes or contracts to
make a loan to such applicant in reliance thereon unless such person (or successor in interest) engaged in fraud or
misrepresentation in making or contracting to make such loan.
(iv) Further terms and conditions
Guarantees of loans under this subsection shall be subject to such further
terms and conditions as the Secretary determines to be necessary to assure that
the purposes of this section will be
achieved.
(3) Loan origination fees
(A) In general
The Secretary shall collect a loan origination fee with respect to loans to be guaranteed under this subsection, except as provided in subparagraph (C).
(B) Amount
The amount of a loan origination fee collected by the Secretary under subparagraph
(A) shall be equal to the estimated long term
cost of the loan guarantees involved to the
Federal Government (excluding administrative costs), calculated on a net present value
basis, after taking into account any appropriations that may be made for the purpose
of offsetting such costs, and in accordance
with the criteria used to award loan guarantees under this subsection.
(C) Waiver
The Secretary may waive the loan origination fee for a health center applicant who
demonstrates to the Secretary that the applicant will be unable to meet the conditions
of the loan if the applicant incurs the additional cost of the fee.
(4) Defaults
(A) In general
Subject to the requirements of the Credit
Reform Act of 1990 1 (2 U.S.C. 661 et seq.), the
Secretary may take such action as may be
necessary to prevent a default on a loan
guaranteed under this subsection, including
the waiver of regulatory conditions, deferral
of loan payments, renegotiation of loans,
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and the expenditure of funds for technical
and consultative assistance, for the temporary payment of the interest and principal
on such a loan, and for other purposes. Any
such expenditure made under the preceding
sentence on behalf of a health center or centers shall be made under such terms and conditions as the Secretary shall prescribe, including the implementation of such organizational, operational, and financial reforms
as the Secretary determines are appropriate
and the disclosure of such financial or other
information as the Secretary may require to
determine the extent of the implementation
of such reforms.
(B) Foreclosure
The Secretary may take such action, consistent with State law respecting foreclosure
procedures and, with respect to reserves required for furnishing services on a prepaid
basis, subject to the consent of the affected
States, as the Secretary determines appropriate to protect the interest of the United
States in the event of a default on a loan
guaranteed under this subsection, except
that the Secretary may only foreclose on assets offered as security (if any) in accordance with paragraph (2)(A)(i).
(5) Limitation
Not more than one loan guarantee may be
made under this subsection for the same network or plan, except that upon a showing of
good cause the Secretary may make additional loan guarantees.
(6) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection such sums as may be
necessary.
(e) Operating grants
(1) Authority
(A) In general
The Secretary may make grants for the
costs of the operation of public and nonprofit private health centers that provide
health services to medically underserved
populations.
(B) Entities that fail to meet certain requirements
The Secretary may make grants, for a period of not to exceed 2 years, for the costs of
the operation of public and nonprofit private
entities which provide health services to
medically underserved populations but with
respect to which the Secretary is unable to
make each of the determinations required by
subsection (k)(3) of this section.
(C) Operation of networks and plans
The Secretary may make grants to health
centers that receive assistance under this
section, or at the request of the health centers, directly to a network or plan (as described in subparagraphs (B) and (C) of subsection (c)(1) of this section) that is at least
majority controlled and, as applicable, at
least majority owned by such health centers
receiving assistance under this section, for

§ 254b

the costs associated with the operation of
such network or plan, including the purchase or lease of equipment (including the
costs of amortizing the principal of, and paying the interest on, loans for equipment).
(2) Use of funds
The costs for which a grant may be made
under subparagraph (A) or (B) of paragraph (1)
may include the costs of acquiring and leasing
buildings and equipment (including the costs
of amortizing the principal of, and paying interest on, loans), and the costs of providing
training related to the provision of required
primary health services and additional health
services and to the management of health center programs.
(3) Construction
The Secretary may award grants which may
be used to pay the costs associated with expanding and modernizing existing buildings or
constructing new buildings (including the
costs of amortizing the principal of, and paying the interest on, loans) for projects approved prior to October 1, 1996.
(4) Limitation
Not more than two grants may be made
under subparagraph (B) of paragraph (1) for
the same entity.
(5) Amount
(A) In general
The amount of any grant made in any fiscal year under subparagraphs (A) and (B) of
paragraph (1) to a health center shall be determined by the Secretary, but may not exceed the amount by which the costs of operation of the center in such fiscal year exceed
the total of—
(i) State, local, and other operational
funding provided to the center; and
(ii) the fees, premiums, and third-party
reimbursements, which the center may
reasonably be expected to receive for its
operations in such fiscal year.
(B) Networks and plans
The total amount of grant funds made
available for any fiscal year under paragraph
(1)(C) and subparagraphs (B) and (C) of subsection (c)(1) of this section to a health center or to a network or plan shall be determined by the Secretary, but may not exceed
2 percent of the total amount appropriated
under this section for such fiscal year.
(C) Payments
Payments under grants under subparagraph (A) or (B) of paragraph (1) shall be
made in advance or by way of reimbursement and in such installments as the Secretary finds necessary and adjustments may
be made for overpayments or underpayments.
(D) Use of nongrant funds
Nongrant funds described in clauses (i) and
(ii) of subparagraph (A), including any such
funds in excess of those originally expected,
shall be used as permitted under this section, and may be used for such other pur-

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

poses as are not specifically prohibited
under this section if such use furthers the
objectives of the project.
(f) Infant mortality grants
(1) In general
The Secretary may make grants to health
centers for the purpose of assisting such centers in—
(A) providing comprehensive health care
and support services for the reduction of—
(i) the incidence of infant mortality; and
(ii) morbidity among children who are
less than 3 years of age; and
(B) developing and coordinating service
and referral arrangements between health
centers and other entities for the health
management of pregnant women and children described in subparagraph (A).
(2) Priority
In making grants under this subsection the
Secretary shall give priority to health centers
providing services to any medically underserved population among which there is a substantial incidence of infant mortality or
among which there is a significant increase in
the incidence of infant mortality.
(3) Requirements
The Secretary may make a grant under this
subsection only if the health center involved
agrees that—
(A) the center will coordinate the provision of services under the grant to each of
the recipients of the services;
(B) such services will be continuous for
each such recipient;
(C) the center will provide follow-up services for individuals who are referred by the
center for services described in paragraph
(1);
(D) the grant will be expended to supplement, and not supplant, the expenditures of
the center for primary health services (including prenatal care) with respect to the
purpose described in this subsection; and
(E) the center will coordinate the provision of services with other maternal and
child health providers operating in the
catchment area.
(g) Migratory and seasonal agricultural workers
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f)
of this section for the planning and delivery of
services to a special medically underserved
population comprised of—
(A) migratory agricultural workers, seasonal agricultural workers, and members of
the families of such migratory and seasonal
agricultural workers who are within a designated catchment area; and
(B) individuals who have previously been
migratory agricultural workers but who no
longer meet the requirements of subparagraph (A) of paragraph (3) because of age or
disability and members of the families of
such individuals who are within such catchment area.

Page 260

(2) Environmental concerns
The Secretary may enter into grants or contracts under this subsection with public and
private entities to—
(A) assist the States in the implementation and enforcement of acceptable environmental health standards, including enforcement of standards for sanitation in migratory agricultural worker and seasonal agricultural worker labor camps, and applicable
Federal and State pesticide control standards; and
(B) conduct projects and studies to assist
the several States and entities which have
received grants or contracts under this section in the assessment of problems related
to camp and field sanitation, exposure to unsafe levels of agricultural chemicals including pesticides, and other environmental
health hazards to which migratory agricultural workers and seasonal agricultural
workers, and members of their families, are
exposed.
(3) Definitions
For purposes of this subsection:
(A) Migratory agricultural worker
The term ‘‘migratory agricultural worker’’
means an individual whose principal employment is in agriculture, who has been so employed within the last 24 months, and who
establishes for the purposes of such employment a temporary abode.
(B) Seasonal agricultural worker
The term ‘‘seasonal agricultural worker’’
means an individual whose principal employment is in agriculture on a seasonal basis
and who is not a migratory agricultural
worker.
(C) Agriculture
The term ‘‘agriculture’’ means farming in
all its branches, including—
(i) cultivation and tillage of the soil;
(ii) the production, cultivation, growing,
and harvesting of any commodity grown
on, in, or as an adjunct to or part of a commodity grown in or on, the land; and
(iii) any practice (including preparation
and processing for market and delivery to
storage or to market or to carriers for
transportation to market) performed by a
farmer or on a farm incident to or in conjunction with an activity described in
clause (ii).
(h) Homeless population
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f)
of this section for the planning and delivery of
services to a special medically underserved
population comprised of homeless individuals,
including grants for innovative programs that
provide outreach and comprehensive primary
health services to homeless children and
youth and children and youth at risk of homelessness.
(2) Required services
In addition to required primary health services (as defined in subsection (b)(1) of this sec-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion), an entity that receives a grant under
this subsection shall be required to provide
substance abuse services as a condition of such
grant.
(3) Supplement not supplant requirement
A grant awarded under this subsection shall
be expended to supplement, and not supplant,
the expenditures of the health center and the
value of in kind contributions for the delivery
of services to the population described in paragraph (1).
(4) Temporary continued provision of services
to certain former homeless individuals
If any grantee under this subsection has provided services described in this section under
the grant to a homeless individual, such grantee may, notwithstanding that the individual is
no longer homeless as a result of becoming a
resident in permanent housing, expend the
grant to continue to provide such services to
the individual for not more than 12 months.
(5) Definitions
For purposes of this section:
(A) Homeless individual
The term ‘‘homeless individual’’ means an
individual who lacks housing (without regard to whether the individual is a member
of a family), including an individual whose
primary residence during the night is a supervised public or private facility that provides temporary living accommodations and
an individual who is a resident in transitional housing.
(B) Substance abuse
The term ‘‘substance abuse’’ has the same
meaning given such term in section
290cc–34(4) of this title.
(C) Substance abuse services
The term ‘‘substance abuse services’’ includes detoxification, risk reduction, outpatient treatment, residential treatment,
and rehabilitation for substance abuse provided in settings other than hospitals.
(i) Residents of public housing
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f)
of this section for the planning and delivery of
services to a special medically underserved
population comprised of residents of public
housing (such term, for purposes of this subsection, shall have the same meaning given
such term in section 1437a(b)(1) of this title)
and individuals living in areas immediately
accessible to such public housing.
(2) Supplement not supplant
A grant awarded under this subsection shall
be expended to supplement, and not supplant,
the expenditures of the health center and the
value of in kind contributions for the delivery
of services to the population described in paragraph (1).
(3) Consultation with residents
The Secretary may not make a grant under
paragraph (1) unless, with respect to the resi-

§ 254b

dents of the public housing involved, the applicant for the grant—
(A) has consulted with the residents in the
preparation of the application for the grant;
and
(B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the program carried out with the grant.
(j) Access grants
(1) In general
The Secretary may award grants to eligible
health centers with a substantial number of
clients with limited English speaking proficiency to provide translation, interpretation,
and other such services for such clients with
limited English speaking proficiency.
(2) Eligible health center
In this subsection, the term ‘‘eligible health
center’’ means an entity that—
(A) is a health center as defined under subsection (a) of this section;
(B) provides health care services for clients for whom English is a second language;
and
(C) has exceptional needs with respect to
linguistic access or faces exceptional challenges with respect to linguistic access.
(3) Grant amount
The amount of a grant awarded to a center
under this subsection shall be determined by
the Administrator. Such determination of
such amount shall be based on the number of
clients for whom English is a second language
that is served by such center, and larger grant
amounts shall be awarded to centers serving
larger numbers of such clients.
(4) Use of funds
An eligible health center that receives a
grant under this subsection may use funds received through such grant to—
(A) provide translation, interpretation,
and other such services for clients for whom
English is a second language, including hiring professional translation and interpretation services; and
(B) compensate bilingual or multilingual
staff for language assistance services provided by the staff for such clients.
(5) Application
An eligible health center desiring a grant
under this subsection shall submit an application to the Secretary at such time, in such
manner, and containing such information as
the Secretary may reasonably require, including—
(A) an estimate of the number of clients
that the center serves for whom English is a
second language;
(B) the ratio of the number of clients for
whom English is a second language to the
total number of clients served by the center;
(C) a description of any language assistance services that the center proposes to
provide to aid clients for whom English is a
second language; and
(D) a description of the exceptional needs
of such center with respect to linguistic ac-

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cess or a description of the exceptional challenges faced by such center with respect to
linguistic access.
(6) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection, in addition to any
funds authorized to be appropriated or appropriated for health centers under any other subsection of this section, such sums as may be
necessary for each of fiscal years 2002 through
2006.
(k) Applications
(1) Submission
No grant may be made under this section unless an application therefore is submitted to,
and approved by, the Secretary. Such an application shall be submitted in such form and
manner and shall contain such information as
the Secretary shall prescribe.
(2) Description of need
An application for a grant under subparagraph (A) or (B) of subsection (e)(1) of this section for a health center shall include—
(A) a description of the need for health
services in the catchment area of the center;
(B) a demonstration by the applicant that
the area or the population group to be served
by the applicant has a shortage of personal
health services; and
(C) a demonstration that the center will be
located so that it will provide services to the
greatest number of individuals residing in
the catchment area or included in such population group.
Such a demonstration shall be made on the
basis of the criteria prescribed by the Secretary under subsection (b)(3) of this section
or on any other criteria which the Secretary
may prescribe to determine if the area or population group to be served by the applicant
has a shortage of personal health services. In
considering an application for a grant under
subparagraph (A) or (B) of subsection (e)(1) of
this section, the Secretary may require as a
condition to the approval of such application
an assurance that the applicant will provide
any health service defined under paragraphs
(1) and (2) of subsection (b) of this section that
the Secretary finds is needed to meet specific
health needs of the area to be served by the
applicant. Such a finding shall be made in
writing and a copy shall be provided to the applicant.
(3) Requirements
Except as provided in subsection (e)(1)(B) of
this section, the Secretary may not approve
an application for a grant under subparagraph
(A) or (B) of subsection (e)(1) of this section
unless the Secretary determines that the entity for which the application is submitted is
a health center (within the meaning of subsection (a) of this section) and that—
(A) the required primary health services of
the center will be available and accessible in
the catchment area of the center promptly,
as appropriate, and in a manner which assures continuity;
(B) the center has made and will continue
to make every reasonable effort to establish

Page 262

and maintain collaborative relationships
with other health care providers in the
catchment area of the center;
(C) the center will have an ongoing quality
improvement system that includes clinical
services and management, and that maintains the confidentiality of patient records;
(D) the center will demonstrate its financial responsibility by the use of such accounting procedures and other requirements
as may be prescribed by the Secretary;
(E) the center—
(i)(I) has or will have a contractual or
other arrangement with the agency of the
State, in which it provides services, which
administers or supervises the administration of a State plan approved under title
XIX of the Social Security Act [42 U.S.C.
1396 et seq.] for the payment of all or a
part of the center’s costs in providing
health services to persons who are eligible
for medical assistance under such a State
plan; and
(II) has or will have a contractual or
other arrangement with the State agency
administering the program under title XXI
of such Act (42 U.S.C. 1397aa et seq.) with
respect to individuals who are State children’s health insurance program beneficiaries; or
(ii) has made or will make every reasonable effort to enter into arrangements described in subclauses (I) and (II) of clause
(i);
(F) the center has made or will make and
will continue to make every reasonable effort to collect appropriate reimbursement
for its costs in providing health services to
persons who are entitled to insurance benefits under title XVIII of the Social Security
Act [42 U.S.C. 1395 et seq.], to medical assistance under a State plan approved under title
XIX of such Act [42 U.S.C. 1396 et seq.], or to
assistance for medical expenses under any
other public assistance program or private
health insurance program;
(G) the center—
(i) has prepared a schedule of fees or payments for the provision of its services consistent with locally prevailing rates or
charges and designed to cover its reasonable costs of operation and has prepared a
corresponding schedule of discounts to be
applied to the payment of such fees or payments, which discounts are adjusted on the
basis of the patient’s ability to pay;
(ii) has made and will continue to make
every reasonable effort—
(I) to secure from patients payment for
services in accordance with such schedules; and
(II) to collect reimbursement for
health services to persons described in
subparagraph (F) on the basis of the full
amount of fees and payments for such
services without application of any discount;
(iii)(I) will assure that no patient will be
denied health care services due to an individual’s inability to pay for such services;
and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(II) will assure that any fees or payments
required by the center for such services
will be reduced or waived to enable the
center to fulfill the assurance described in
subclause (I); and
(iv) has submitted to the Secretary such
reports as the Secretary may require to
determine compliance with this subparagraph;
(H) the center has established a governing
board which except in the case of an entity
operated by an Indian tribe or tribal or Indian organization under the Indian Self-Determination Act [25 U.S.C. 450f et seq.] or an
urban Indian organization under the Indian
Health Care Improvement Act (25 U.S.C. 1651
et seq.)—
(i) is composed of individuals, a majority
of whom are being served by the center
and who, as a group, represent the individuals being served by the center;
(ii) meets at least once a month, selects
the services to be provided by the center,
schedules the hours during which such
services will be provided, approves the center’s annual budget, approves the selection
of a director for the center, and, except in
the case of a governing board of a public
center (as defined in the second sentence
of this paragraph), establishes general
policies for the center; and
(iii) in the case of an application for a
second or subsequent grant for a public
center, has approved the application or if
the governing body has not approved the
application, the failure of the governing
body to approve the application was unreasonable;
except that, upon a showing of good cause
the Secretary shall waive, for the length of
the project period, all or part of the requirements of this subparagraph in the case of a
health center that receives a grant pursuant
to subsection (g), (h), (i), or (p) of this section;
(I) the center has developed—
(i) an overall plan and budget that meets
the requirements of the Secretary; and
(ii) an effective procedure for compiling
and reporting to the Secretary such statistics and other information as the Secretary may require relating to—
(I) the costs of its operations;
(II) the patterns of use of its services;
(III) the availability, accessibility, and
acceptability of its services; and
(IV) such other matters relating to operations of the applicant as the Secretary may require;
(J) the center will review periodically its
catchment area to—
(i) ensure that the size of such area is
such that the services to be provided
through the center (including any satellite) are available and accessible to the
residents of the area promptly and as appropriate;
(ii) ensure that the boundaries of such
area conform, to the extent practicable, to
relevant boundaries of political subdivi-

§ 254b

sions, school districts, and Federal and
State health and social service programs;
and
(iii) ensure that the boundaries of such
area eliminate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the
area’s physical characteristics, its residential patterns, its economic and social
grouping, and available transportation;
(K) in the case of a center which serves a
population including a substantial proportion of individuals of limited English-speaking ability, the center has—
(i) developed a plan and made arrangements responsive to the needs of such population for providing services to the extent
practicable in the language and cultural
context most appropriate to such individuals; and
(ii) identified an individual on its staff
who is fluent in both that language and in
English and whose responsibilities shall
include providing guidance to such individuals and to appropriate staff members with
respect to cultural sensitivities and bridging linguistic and cultural differences;
(L) the center, has developed an ongoing
referral relationship with one or more hospitals; and
(M) the center encourages persons receiving or seeking health services from the center to participate in any public or private
(including employer-offered) health programs or plans for which the persons are eligible, so long as the center, in complying
with this subparagraph, does not violate the
requirements of subparagraph (G)(iii)(I).
For purposes of subparagraph (H), the term
‘‘public center’’ means a health center funded
(or to be funded) through a grant under this
section to a public agency.
(4) Approval of new or expanded service applications
The Secretary shall approve applications for
grants under subparagraph (A) or (B) of subsection (e)(1) of this section for health centers
which—
(A) have not received a previous grant
under such subsection; or
(B) have applied for such a grant to expand
their services;
in such a manner that the ratio of the medically underserved populations in rural areas
which may be expected to use the services provided by such centers to the medically underserved populations in urban areas which may
be expected to use the services provided by
such centers is not less than two to three or
greater than three to two.
(l) Technical assistance
The Secretary shall establish a program
through which the Secretary shall provide (either through the Department of Health and
Human Services or by grant or contract) technical and other assistance to eligible entities to
assist such entities to meet the requirements of
subsection (k)(3) of this section. Services pro-

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

vided through the program may include necessary technical and nonfinancial assistance, including fiscal and program management assistance, training in fiscal and program management, operational and administrative support,
and the provision of information to the entities
of the variety of resources available under this
subchapter and how those resources can be best
used to meet the health needs of the communities served by the entities.
(m) Memorandum of agreement
In carrying out this section, the Secretary
may enter into a memorandum of agreement
with a State. Such memorandum may include,
where appropriate, provisions permitting such
State to—
(1) analyze the need for primary health services for medically underserved populations
within such State;
(2) assist in the planning and development of
new health centers;
(3) review and comment upon annual program plans and budgets of health centers, including comments upon allocations of health
care resources in the State;
(4) assist health centers in the development
of clinical practices and fiscal and administrative systems through a technical assistance
plan which is responsive to the requests of
health centers; and
(5) share information and data relevant to
the operation of new and existing health centers.
(n) Records
(1) In general
Each entity which receives a grant under
subsection (e) of this section shall establish
and maintain such records as the Secretary
shall require.
(2) Availability
Each entity which is required to establish
and maintain records under this subsection
shall make such books, documents, papers,
and records available to the Secretary or the
Comptroller General of the United States, or
any of their duly authorized representatives,
for examination, copying or mechanical reproduction on or off the premises of such entity
upon a reasonable request therefore. The Secretary and the Comptroller General of the
United States, or any of their duly authorized
representatives, shall have the authority to
conduct such examination, copying, and reproduction.
(o) Delegation of authority
The Secretary may delegate the authority to
administer the programs authorized by this section to any office, except that the authority to
enter into, modify, or issue approvals with respect to grants or contracts may be delegated
only within the central office of the Health Resources and Services Administration.
(p) Special consideration
In making grants under this section, the Secretary shall give special consideration to the
unique needs of sparsely populated rural areas,
including giving priority in the awarding of

Page 264

grants for new health centers under subsections
(c) and (e) of this section, and the granting of
waivers as appropriate and permitted under subsections (b)(1)(B)(i) and (k)(3)(G) of this section.
(q) Audits
(1) In general
Each entity which receives a grant under
this section shall provide for an independent
annual financial audit of any books, accounts,
financial records, files, and other papers and
property which relate to the disposition or use
of the funds received under such grant and
such other funds received by or allocated to
the project for which such grant was made.
For purposes of assuring accurate, current,
and complete disclosure of the disposition or
use of the funds received, each such audit shall
be conducted in accordance with generally accepted accounting principles. Each audit shall
evaluate—
(A) the entity’s implementation of the
guidelines established by the Secretary respecting cost accounting,
(B) the processes used by the entity to
meet the financial and program reporting requirements of the Secretary, and
(C) the billing and collection procedures of
the entity and the relation of the procedures
to its fee schedule and schedule of discounts
and to the availability of health insurance
and public programs to pay for the health
services it provides.
A report of each such audit shall be filed with
the Secretary at such time and in such manner as the Secretary may require.
(2) Records
Each entity which receives a grant under
this section shall establish and maintain such
records as the Secretary shall by regulation
require to facilitate the audit required by
paragraph (1). The Secretary may specify by
regulation the form and manner in which such
records shall be established and maintained.
(3) Availability of records
Each entity which is required to establish
and maintain records or to provide for and 2
audit under this subsection shall make such
books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly
authorized representatives, for examination,
copying or mechanical reproduction on or off
the premises of such entity upon a reasonable
request therefore. The Secretary and the
Comptroller General of the United States, or
any of their duly authorized representatives,
shall have the authority to conduct such examination, copying, and reproduction.
(4) Waiver
The Secretary may, under appropriate circumstances, waive the application of all or
part of the requirements of this subsection
with respect to an entity.
(r) Authorization of appropriations
(1) General amounts for grants
For the purpose of carrying out this section,
in addition to the amounts authorized to be
2 So

in original. Probably should be ‘‘an’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

appropriated under subsection (d), there is authorized to be appropriated the following:
(A) For fiscal year 2010, $2,988,821,592.
(B) For fiscal year 2011, $3,862,107,440.
(C) For fiscal year 2012, $4,990,553,440.
(D) For fiscal year 2013, $6,448,713,307.
(E) For fiscal year 2014, $7,332,924,155.
(F) For fiscal year 2015, $8,332,924,155.
(G) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated
for the preceding fiscal year adjusted by the
product of—
(i) one plus the average percentage increase in costs incurred per patient served;
and
(ii) one plus the average percentage increase in the total number of patients
served.
(2) Special provisions
(A) Public centers
The Secretary may not expend in any fiscal year, for grants under this section to
public centers (as defined in the second sentence of subsection (k)(3) of this section) the
governing boards of which (as described in
subsection (k)(3)(H) of this section) do not
establish general policies for such centers,
an amount which exceeds 5 percent of the
amounts appropriated under this section for
that fiscal year. For purposes of applying
the preceding sentence, the term ‘‘public
centers’’ shall not include health centers
that receive grants pursuant to subsection
(h) or (i) of this section.
(B) Distribution of grants
For fiscal year 2002 and each of the following fiscal years, the Secretary, in awarding
grants under this section, shall ensure that
the proportion of the amount made available
under each of subsections (g), (h), and (i) of
this section, relative to the total amount appropriated to carry out this section for that
fiscal year, is equal to the proportion of the
amount made available under that subsection for fiscal year 2001, relative to the
total amount appropriated to carry out this
section for fiscal year 2001.
(3) Funding report
The Secretary shall annually prepare and
submit to the appropriate committees of Congress a report concerning the distribution of
funds under this section that are provided to
meet the health care needs of medically underserved populations, including the homeless,
residents of public housing, and migratory and
seasonal agricultural workers, and the appropriateness of the delivery systems involved in
responding to the needs of the particular populations. Such report shall include an assessment of the relative health care access needs
of the targeted populations and the rationale
for any substantial changes in the distribution
of funds.
(4) Rule of construction with respect to rural
health clinics
(A) In general
Nothing in this section shall be construed
to prevent a community health center from

§ 254b

contracting with a Federally certified rural
health clinic (as defined in section 1861(aa)(2)
of the Social Security Act [42 U.S.C.
1395x(aa)(2)]), a low-volume hospital (as defined for purposes of section 1886 of such Act
[42 U.S.C. 1395ww]), a critical access hospital, a sole community hospital (as defined
for purposes of section 1886(d)(5)(D)(iii) of
such Act), or a medicare-dependent share
hospital (as defined for purposes of section
1886(d)(5)(G)(iv) of such Act) for the delivery
of primary health care services that are
available at the clinic or hospital to individuals who would otherwise be eligible for free
or reduced cost care if that individual were
able to obtain that care at the community
health center. Such services may be limited
in scope to those primary health care services available in that clinic or hospitals.3
(B) Assurances
In order for a clinic or hospital to receive
funds under this section through a contract
with a community health center under subparagraph (A), such clinic or hospital shall
establish policies to ensure—
(i) nondiscrimination based on the ability of a patient to pay; and
(ii) the establishment of a sliding fee
scale for low-income patients.
(s) Demonstration program for individualized
wellness plans
(1) In general
The Secretary shall establish a pilot program to test the impact of providing at-risk
populations who utilize community health
centers funded under this section an individualized wellness plan that is designed to reduce risk factors for preventable conditions as
identified by a comprehensive risk-factor assessment.
(2) Agreements
The Secretary shall enter into agreements
with not more than 10 community health centers funded under this section to conduct activities under the pilot program under paragraph (1).
(3) Wellness plans
(A) In general
An individualized wellness plan prepared
under the pilot program under this subsection may include one or more of the following as appropriate to the individual’s
identified risk factors:
(i) Nutritional counseling.
(ii) A physical activity plan.
(iii) Alcohol and smoking cessation
counseling and services.
(iv) Stress management.
(v) Dietary supplements that have health
claims approved by the Secretary.
(vi) Compliance assistance provided by a
community health center employee.
(B) Risk factors
Wellness plan risk factors shall include—
(i) weight;
3 So

in original. Probably should be ‘‘hospital’’.

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) tobacco and alcohol use;
(iii) exercise rates;
(iv) nutritional status; and
(v) blood pressure.
(C) Comparisons
Individualized wellness plans shall make
comparisons between the individual involved
and a control group of individuals with respect to the risk factors described in subparagraph (B).
(4) Authorization of appropriations
There is authorized to be appropriated to
carry out this subsection, such sums as may
be necessary.
(July 1, 1944, ch. 373, title III, § 330, as added Pub.
L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626; amended Pub. L. 107–251, title I, § 101, Oct. 26, 2002, 116
Stat. 1622; Pub. L. 108–163, § 2(a), Dec. 6, 2003, 117
Stat. 2020; Pub. L. 110–355, § 2(a), (c)(1), Oct. 8,
2008, 122 Stat. 3988, 3992; Pub. L. 111–148, title IV,
§ 4206, title V, § 5601, Mar. 23, 2010, 124 Stat. 576,
676.)
REFERENCES IN TEXT
The Federal Credit Reform Act of 1990, referred to in
subsec. (d)(1)(E), is title V of Pub. L. 93–344, as added by
Pub. L. 101–508, title XIII, § 13201(a), Nov. 5, 1990, 104
Stat. 1388–609, which is classified generally to subchapter III (§ 661 et seq.) of chapter 17A of Title 2, The
Congress. The Credit Reform Act of 1990, referred to in
subsec. (d)(4)(A), probably means the Federal Credit Reform Act of 1990. For complete classification of this Act
to the Code, see Short Title note set out under section
621 of Title 2 and Tables.
The Social Security Act, referred to in subsec.
(k)(3)(E)(i), (F), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.
Titles XVIII, XIX, and XXI of the Act are classified
generally to subchapters XVIII (§ 1395 et seq.), XIX
(§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively,
of chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
The Indian Self-Determination Act, referred to in
subsec. (k)(3)(H), is title I of Pub. L. 93–638, Jan. 4, 1975,
88 Stat. 2206, which is classified principally to part A
(§ 450f et seq.) of subchapter II of chapter 14 of Title 25,
Indians. For complete classification of this Act to the
Code, see Short Title note set out under section 450 of
Title 25 and Tables.
The Indian Health Care Improvement Act, referred to
in subsec. (k)(3)(H), is Pub. L. 94–437, Sept. 30, 1976, 90
Stat. 1400, which is classified principally to chapter 18
(§ 1601 et seq.) of Title 25. For complete classification of
this Act to the Code, see Short Title note set out under
section 1601 of Title 25 and Tables.
PRIOR PROVISIONS
A prior section 254a–1, act July 1, 1944, ch. 373, title
III, § 328, as added Nov. 10, 1978, Pub. L. 95–626, title I,
§ 114, 92 Stat. 3563; amended Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695, related to hospital-affiliated primary care centers, prior to repeal by Pub. L.
99–117, § 12(c), Oct. 7, 1985, 99 Stat. 495.
A prior section 254b, act July 1, 1944, ch. 373, title III,
§ 329, formerly § 310, as added Sept. 25, 1962, Pub. L.
87–692, 76 Stat. 592; amended Aug. 5, 1965, Pub. L. 89–109,
§ 3, 79 Stat. 436; Oct. 15, 1968, Pub. L. 90–574, title II,
§ 201, 82 Stat. 1006; Mar. 12, 1970, Pub. L. 91–209, 84 Stat.
52; June 18, 1973, Pub. L. 93–45, title I, § 105, 87 Stat. 91;
renumbered § 319, July 23, 1974, Pub. L. 93–353, title I,
§ 102(d), 88 Stat. 362; amended July 29, 1975, Pub. L.
94–63, title IV, § 401(a), title VII, § 701(c), 89 Stat. 334, 352;
Apr. 22, 1976, Pub. L. 94–278, title VIII, § 801(a), 90 Stat.
414; Aug. 1, 1977, Pub. L. 95–83, title III, § 303, 91 Stat.
388; renumbered § 329 and amended Nov. 10, 1978, Pub. L.

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95–626, title I, §§ 102(a), 103(a)–(g)(1)(B), (2), (h), (i), 92
Stat. 3551–3555; July 10, 1979, Pub. L. 96–32, § 6(a), 93
Stat. 83; Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93
Stat. 695; Aug. 13, 1981, Pub. L. 97–35, title IX, § 930, 95
Stat. 569; Dec. 21, 1982, Pub. L. 97–375, title I, § 107(b), 96
Stat. 1820; Apr. 24, 1986, Pub. L. 99–280, §§ 6, 7, 100 Stat.
400, 401; Aug. 10, 1988, Pub. L. 100–386, § 2, 102 Stat. 919;
Nov. 6, 1990, Pub. L. 101–527, § 9(b), 104 Stat. 2333; Oct. 27,
1992, Pub. L. 102–531, title III, § 309(a), 106 Stat. 3499, related to migrant health centers, prior to the general
amendment of this subpart by Pub. L. 104–299, § 2.
Another prior section 254b, act July 1, 1944, ch. 373,
title III, § 329, as added Dec. 31, 1970, Pub. L. 91–623, § 2,
84 Stat. 1868; amended Nov. 18, 1971, Pub. L. 92–157, title
II, § 203, 85 Stat. 462; Oct. 27, 1972, Pub. L. 92–585, § 2, 86
Stat. 1290; July 29, 1975, Pub. L. 94–63, title VIII,
§§ 801–803, 89 Stat. 353, 354; Oct. 12, 1976, Pub. L. 94–484,
title I, § 101(b), 90 Stat. 2244, related to establishment of
National Health Service Corps, assignment of personnel
and statement of purpose, prior to repeal by Pub. L.
94–484, title IV, § 407(b)(1), Oct. 12, 1976, 90 Stat. 2268. See
section 254d et seq. of this title.
A prior section 330 of act July 1, 1944, was classified
to section 254c of this title prior to the general amendment of this subpart by Pub. L. 104–299.
AMENDMENTS
2010—Subsec. (r)(1). Pub. L. 111–148, § 5601(a), added
par. (1) and struck out former par. (1). Prior to amendment, text read as follows: ‘‘For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d), there are
authorized to be appropriated—
‘‘(A) $2,065,000,000 for fiscal year 2008;
‘‘(B) $2,313,000,000 for fiscal year 2009;
‘‘(C) $2,602,000,000 for fiscal year 2010;
‘‘(D) $2,940,000,000 for fiscal year 2011; and
‘‘(E) $3,337,000,000 for fiscal year 2012.’’
Subsec. (r)(4). Pub. L. 111–148, § 5601(b), added par. (4).
Subsec. (s). Pub. L. 111–148, § 4206, added subsec. (s).
2008—Subsec. (c)(3). Pub. L. 110–355, § 2(c)(1), added
par. (3).
Subsec. (r)(1). Pub. L. 110–355, § 2(a), amended par. (1)
generally. Prior to amendment, text read as follows:
‘‘For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated
under subsection (d) of this section, there are authorized to be appropriated $1,340,000,000 for fiscal year 2002
and such sums as may be necessary for each of the fiscal years 2003 through 2006.’’
2003—Subsec. (c)(1)(B). Pub. L. 108–163, § 2(a)(2)(A),
substituted ‘‘plan.’’ for ‘‘plan..’’ in introductory provisions.
Subsec. (d)(1)(B)(iii)(I). Pub. L. 108–163, § 2(a)(2)(B), inserted ‘‘or’’ at end.
Subsec. (e)(3) to (5). Pub. L. 108–163, § 2(a)(1)(A),
amended pars. (3) to (5) to read as if subpar. (C) of the
second par. (4) of section 101 of Pub. L. 107–251 had not
been enacted. See 2002 Amendment notes below.
Subsec. (j). Pub. L. 108–163, § 2(a)(2)(E), added subsec.
(j) identical to the subsec. (j) appearing in the amendment by section 101(8)(C) of Pub. L. 107–251. See 2002
Amendment notes below. Former subsec. (j) redesignated (k).
Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (j) to
read as if pars. (8) through (11) of section 101 of Pub. L.
107–251 had not been enacted. See 2002 Amendment
notes below.
Subsec. (j)(3)(H). Pub. L. 108–163, § 2(a)(1)(B), amended
subpar. (H) to read as if subpar. (C) of par. (7) of section
101 of Pub. L. 107–251 had not been enacted. See 2002
Amendment note below.
Subsec. (k). Pub. L. 108–163, § 2(a)(2)(C), (D), redesignated subsec. (j) as (k) and struck out heading and text
of former subsec. (k). Text read as follows: ‘‘The Secretary may provide (either through the Department of
Health and Human Services or by grant or contract) all
necessary technical and other nonfinancial assistance
(including fiscal and program management assistance
and training in such management) to any public or pri-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

vate nonprofit entity to assist entities in developing
plans for, or operating as, health centers, and in meeting the requirements of subsection (j)(2) of this section.’’
Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (k) to
read as if pars. (8) through (11) of section 101 of Pub. L.
107–251 had not been enacted. See 2002 Amendment
notes below.
Subsec. (l). Pub. L. 108–163, § 2(a)(2)(H), inserted ‘‘(either through the Department of Health and Human
Services or by grant or contract)’’ after ‘‘shall provide’’
and substituted ‘‘(k)(3)’’ for ‘‘(l)(3)’’.
Pub. L. 108–163, § 2(a)(2)(G), added subsec. (l) identical
to the subsec. (m) appearing in the amendment by section 101(9) of Pub. L. 107–251. See 2002 Amendment notes
below. Former subsec. (l) redesignated (r).
Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (l) to read
as if pars. (8) through (11) of section 101 of Pub. L.
107–251 had not been enacted. See 2002 Amendment note
below.
Subsecs. (m) to (o). Pub. L. 108–163, § 2(a)(1)(C), amended subsecs. (m) to (o) to read as if pars. (8) through (11)
of section 101 of Pub. L. 107–251 had not been enacted.
See 2002 Amendment notes below.
Subsec. (p). Pub. L. 108–163, § 2(a)(2)(I), substituted
‘‘(k)(3)(G)’’ for ‘‘(j)(3)(G)’’.
Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (p) to
read as if pars. (8) through (11) of section 101 of Pub. L.
107–251 had not been enacted. See 2002 Amendment note
below.
Subsec. (q). Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (q) to read as if pars. (8) through (11) of section 101
of Pub. L. 107–251 had not been enacted. See 2002
Amendment note below.
Subsec. (r). Pub. L. 108–163, § 2(a)(2)(F), redesignated
subsec. (l) as (r).
Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (r) to
read as if pars. (8) through (11) of section 101 of Pub. L.
107–251 had not been enacted. See 2002 Amendment note
below.
Subsec. (r)(1). Pub. L. 108–163, § 2(a)(2)(J)(i), substituted ‘‘$1,340,000,000 for fiscal year 2002 and such
sums as may be necessary for each of the fiscal years
2003 through 2006’’ for ‘‘$802,124,000 for fiscal year 1997,
and such sums as may be necessary for each of the fiscal years 1998 through 2001’’.
Subsec. (r)(2)(A). Pub. L. 108–163, § 2(a)(2)(J)(ii), substituted ‘‘(k)(3)’’ for ‘‘(j)(3)’’ and ‘‘(k)(3)(H)’’ for
‘‘(j)(3)(G)(ii)’’.
Subsec. (r)(2)(B). Pub. L. 108–163, § 2(a)(2)(J)(iii), added
subpar. (B) identical to the subpar. (B) appearing in the
amendment by section 101(11)(B)(ii) of Pub. L. 107–251
and struck out heading and text of former subpar. (B)
relating to distribution of grants for fiscal years 1997
through 1999. See 2002 Amendment note below.
Subsec. (s). Pub. L. 108–163, § 2(a)(1)(C), amended subsec. (s) to read as if pars. (8) through (11) of section 101
of Pub. L. 107–251 had not been enacted. See 2002
Amendment notes below.
2002—Subsec. (b)(1)(A)(i)(III)(bb). Pub. L. 107–251,
§ 101(1)(A), substituted ‘‘appropriate cancer screening’’
for ‘‘screening for breast and cervical cancer’’.
Subsec. (b)(1)(A)(ii). Pub. L. 107–251, § 101(1)(B), inserted ‘‘(including specialty referral when medically indicated)’’ after ‘‘medical services’’.
Subsec. (b)(1)(A)(iii). Pub. L. 107–251, § 101(1)(C), inserted ‘‘housing,’’ after ‘‘social,’’.
Subsec. (b)(2)(A). Pub. L. 107–251, § 101(2)(C), added
subpar. (A). Former subpar. (A) redesignated (C).
Subsec. (b)(2)(A)(i). Pub. L. 107–251, § 101(2)(A), substituted ‘‘associated with—’’ and subcls. (I) to (IV) for
‘‘associated with water supply;’’.
Subsec. (b)(2)(B) to (D). Pub. L. 107–251, § 101(2)(B), (C),
added subpar. (B) and redesignated former subpars. (A)
and (B) as (C) and (D), respectively.
Subsec. (c)(1)(B). Pub. L. 107–251, § 101(3)(A)(iii),
struck out concluding provisions which read as follows:
‘‘Any such grant may include the acquisition and lease
of buildings and equipment which may include data and
information systems (including the costs of amortizing

§ 254b

the principal of, and paying the interest on, loans), and
providing training and technical assistance related to
the provision of health services on a prepaid basis or
under another managed care arrangement, and for
other purposes that promote the development of managed care networks and plans.’’
Pub. L. 107–251, § 101(3)(A)(ii), in introductory provisions, substituted ‘‘managed care network or plan.’’ for
‘‘network or plan for the provision of health services,
which may include the provision of health services on
a prepaid basis or through another managed care arrangement, to some or to all of the individuals which
the centers serve’’.
Pub. L. 107–251, § 101(3)(A)(i), substituted ‘‘Managed
care’’ for ‘‘Comprehensive service delivery’’ in heading.
Subsec. (c)(1)(C), (D). Pub. L. 107–251, § 101(3)(B), added
subpars. (C) and (D).
Subsec. (d). Pub. L. 107–251, § 101(4)(A), substituted
‘‘Loan guarantee program’’ for ‘‘Managed care loan
guarantee program’’ in heading.
Subsec. (d)(1)(A). Pub. L. 107–251, § 101(4)(B)(i), substituted ‘‘up to 90 percent of the principal and interest
on loans made by non-Federal lenders to health centers, funded under this section, for the costs of developing and operating managed care networks or plans described in subsection (c)(1)(B) of this section, or practice management networks described in subsection
(c)(1)(C) of this section’’ for ‘‘the principal and interest
on loans made by non-Federal lenders to health centers
funded under this section for the costs of developing
and operating managed care networks or plans’’.
Subsec. (d)(1)(B)(iii). Pub. L. 107–251, § 101(4)(B)(ii),
added cl. (iii).
Subsec. (d)(1)(D), (E). Pub. L. 107–251, § 101(4)(B)(iii),
added subpars. (D) and (E).
Subsec. (d)(6) to (8). Pub. L. 107–251, § 101(4)(C), redesignated par. (8) as (6) and struck out headings and text
of former pars. (6) and (7) which related to annual reports and program evaluation, respectively.
Subsec. (e)(1)(B). Pub. L. 107–251, § 101(4)(A)(i), substituted ‘‘subsection (k)(3)’’ for ‘‘subsection (j)(3)’’.
Subsec. (e)(1)(C). Pub. L. 107–251, § 101(4)(A)(ii), added
subpar. (C).
Subsec. (e)(3). Pub. L. 107–251, § 101(4)(C), redesignated
par. (4), relating to limitation, as (3).
Subsec. (e)(4). Pub. L. 107–251, § 101(4)(C), redesignated
par. (5) as (4). Former par. (4) redesignated (3).
Subsec. (e)(5). Pub. L. 107–251, § 101(4)(B), (C), redesignated par. (5) as (4), inserted ‘‘subparagraphs (A) and
(B) of’’ after ‘‘any fiscal year under’’ in subpar. (A),
added subpar. (B), and redesignated former subpars. (B)
and (C) as (C) and (D), respectively.
Subsec. (g)(2)(A). Pub. L. 107–251, § 101(5)(A)(i), inserted ‘‘and seasonal agricultural worker’’ after ‘‘migratory agricultural worker’’.
Subsec. (g)(2)(B). Pub. L. 107–251, § 101(5)(A)(ii), substituted ‘‘and seasonal agricultural workers, and members of their families,’’ for ‘‘and members of their families’’.
Subsec. (g)(3)(A). Pub. L. 107–251, § 101(5)(B), struck
out ‘‘on a seasonal basis’’ after ‘‘in agriculture’’.
Subsec. (h)(1). Pub. L. 107–251, § 101(6)(A), substituted
‘‘homeless children and youth and children and youth
at risk of homelessness’’ for ‘‘homeless children and
children at risk of homelessness’’.
Subsec. (h)(4). Pub. L. 107–251, § 101(6)(B)(ii), added
par. (4). Former par. (4) redesignated (5).
Subsec. (h)(5). Pub. L. 107–251, § 101(6)(B)(i), (C), redesignated par. (4) as (5) and substituted ‘‘, risk reduction,
outpatient treatment, residential treatment, and rehabilitation’’ for ‘‘and residential treatment’’ in subpar.
(C).
Subsec. (j). Pub. L. 107–251, § 101(8)(C), added subsec.
(j) relating to access grants.
Pub. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not
be executed.
Subsec. (j)(3)(E)(i). Pub. L. 107–251, § 101(7)(A)(i), designated existing provisions as subcl. (I) and added
subcl. (II).

§ 254b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (j)(3)(E)(ii). Pub. L. 107–251, § 101(7)(A)(ii), substituted ‘‘arrangements described in subclauses (I) and
(II) of clause (i)’’ for ‘‘such an arrangement’’.
Subsec. (j)(3)(G)(iii), (iv). Pub. L. 107–251, § 101(7)(B),
added cl. (iii) and redesignated former cl. (iii) as (iv).
Subsec. (j)(3)(H). Pub. L. 107–251, § 101(7)(C), substituted ‘‘or (q)’’ for ‘‘or (p)’’ in concluding provisions.
Subsec. (j)(3)(M). Pub. L. 107–251, § 101(7)(D)–(F), added
subpar. (M).
Subsec. (k). Pub. L. 107–251, § 101(8)(B), which directed
the redesignation of subsecs. (j), (k), and (m) through
(q) as subsecs. (n), (o), and (p) through (s), respectively,
could not be executed.
Subsec. (l). Pub. L. 107–251, § 101(8)(A), redesignated
subsec. (l) as (s).
Subsec. (m). Pub. L. 107–251, § 101(9), which directed
striking subsec. (m) (as redesignated by paragraph
(9)(B)) and adding a new subsec. (m), could not be executed. The new subsec. (m) to be added read as follows:
‘‘(m) TECHNICAL ASSISTANCE.—The Secretary shall establish a program through which the Secretary shall
provide technical and other assistance to eligible entities to assist such entities to meet the requirements of
subsection (l)(3) of this section. Services provided
through the program may include necessary technical
and nonfinancial assistance, including fiscal and program management assistance, training in fiscal and
program management, operational and administrative
support, and the provision of information to the entities of the variety of resources available under this subchapter and how those resources can be best used to
meet the health needs of the communities served by
the entities.’’
Pub. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not
be executed.
Subsecs. (n) to (p). Pub. L. 107–251, § 101(8)(B), which
directed the redesignation of subsecs. (j), (k), and (m)
through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.
Subsec. (q). Pub. L. 107–251, § 101(10), which directed
the substitution of ‘‘(l)(3)(G)’’ for ‘‘(j)(3)(G)’’ in subsec.
(q) ‘‘(as redesignated by paragraph (9)(B))’’, could not
be executed.
Pub. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not
be executed.
Subsec. (r). Pub. L. 107–251, § 101(8)(B), which directed
the redesignation of subsecs. (j), (k), and (m) through
(q) as subsecs. (n), (o), and (p) through (s), respectively,
could not be executed.
Subsec. (s). Pub. L. 107–251, § 101(8)(B), which directed
the redesignation of subsecs. (j), (k), and (m) through
(q) as subsecs. (n), (o), and (p) through (s), respectively,
could not be executed.
Subsec. (s)(1). Pub. L. 107–251, § 101(11)(A), substituted
‘‘$1,340,000,000 for fiscal year 2002 and such sums as may
be necessary for each of the fiscal years 2003 through
2006’’ for ‘‘$802,124,000 for fiscal year 1997, and such sums
as may be necessary for each of the fiscal years 1998
through 2001’’.
Subsec. (s)(2)(A). Pub. L. 107–251, § 101(11)(B)(i), substituted ‘‘(l)(3)’’ for ‘‘(j)(3)’’ and ‘‘(l)(3)(H)’’ for
‘‘(j)(3)(G)(ii)’’.
Subsec. (s)(2)(B). Pub. L. 107–251, § 101(11)(B)(ii), added
subpar. (B) and struck out heading and text of former
subpar. (B) relating to distribution of grants for fiscal
years 1997 through 1999.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–355, § 2(c)(2), Oct. 8, 2008, 122 Stat. 3992,
provided that: ‘‘The amendment made by paragraph (1)
[amending this section] shall apply to grants made on
or after January 1, 2009.’’
EFFECTIVE DATE OF 2003 AMENDMENT
Amendments by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.

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107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1996, see section 5 of Pub. L.
104–299, as amended, set out as an Effective Date of 1996
Amendment note under section 233 of this title.
SAVINGS PROVISION FOR CURRENT GRANTS, CONTRACTS,
AND COOPERATIVE AGREEMENTS
Section 3(b) of Pub. L. 104–299 provided that: ‘‘The
Secretary of Health and Human Services shall ensure
the continued funding of grants made, or contracts or
cooperative agreements entered into, under subpart I of
part D of title III of the Public Health Service Act (42
U.S.C. 254b et seq.) (as such subpart existed on the day
prior to the date of enactment of this Act [Oct. 11,
1996]), until the expiration of the grant period or the
term of the contract or cooperative agreement. Such
funding shall be continued under the same terms and
conditions as were in effect on the date on which the
grant, contract or cooperative agreement was awarded,
subject to the availability of appropriations.’’
NEGOTIATED RULEMAKING FOR DEVELOPMENT OF METHODOLOGY AND CRITERIA FOR DESIGNATING MEDICALLY
UNDERSERVED POPULATIONS AND HEALTH PROFESSIONS SHORTAGE AREAS
Pub. L. 111–148, title V, § 5602, Mar. 23, 2010, 124 Stat.
677, provided that:
‘‘(a) ESTABLISHMENT.—
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services (in this section referred to as the
‘Secretary’) shall establish, through a negotiated
rulemaking process under subchapter 3 [III] of chapter 5 of title 5, United States Code, a comprehensive
methodology and criteria for designation of—
‘‘(A) medically underserved populations in accordance with section 330(b)(3) of the Public Health
Service Act (42 U.S.C. 254b(b)(3));
‘‘(B) health professions shortage areas under section 332 of the Public Health Service Act (42 U.S.C.
254e).
‘‘(2) FACTORS TO CONSIDER.—In establishing the
methodology and criteria under paragraph (1), the
Secretary—
‘‘(A) shall consult with relevant stakeholders who
will be significantly affected by a rule (such as national, State and regional organizations representing affected entities), State health offices, community organizations, health centers and other affected entities, and other interested parties; and
‘‘(B) shall take into account—
‘‘(i) the timely availability and appropriateness
of data used to determine a designation to potential applicants for such designations;
‘‘(ii) the impact of the methodology and criteria
on communities of various types and on health
centers and other safety net providers;
‘‘(iii) the degree of ease or difficulty that will
face potential applicants for such designations in
securing the necessary data; and
‘‘(iv) the extent to which the methodology accurately measures various barriers that confront individuals and population groups in seeking health
care services.
‘‘(b) PUBLICATION OF NOTICE.—In carrying out the
rulemaking process under this subsection, the Secretary shall publish the notice provided for under section 564(a) of title 5, United States Code, by not later
than 45 days after the date of the enactment of this Act
[Mar. 23, 2010].
‘‘(c) TARGET DATE FOR PUBLICATION OF RULE.—As part
of the notice under subsection (b), and for purposes of
this subsection, the ‘target date for publication’, as referred to in section 564(a)(5) of title 5, United Sates [sic]
Code, shall be July 1, 2010.
‘‘(d) APPOINTMENT OF NEGOTIATED RULEMAKING COMMITTEE AND FACILITATOR.—The Secretary shall provide
for—

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‘‘(1) the appointment of a negotiated rulemaking
committee under section 565(a) of title 5, United
States Code, by not later than 30 days after the end
of the comment period provided for under section
564(c) of such title; and
‘‘(2) the nomination of a facilitator under section
566(c) of such title 5 by not later than 10 days after
the date of appointment of the committee.
‘‘(e) PRELIMINARY COMMITTEE REPORT.—The negotiated rulemaking committee appointed under subsection (d) shall report to the Secretary, by not later
than April 1, 2010, regarding the committee’s progress
on achieving a consensus with regard to the rulemaking proceeding and whether such consensus is likely to occur before one month before the target date for
publication of the rule. If the committee reports that
the committee has failed to make significant progress
toward such consensus or is unlikely to reach such consensus by the target date, the Secretary may terminate
such process and provide for the publication of a rule
under this section through such other methods as the
Secretary may provide.
‘‘(f) FINAL COMMITTEE REPORT.—If the committee is
not terminated under subsection (e), the rulemaking
committee shall submit a report containing a proposed
rule by not later than one month before the target publication date.
‘‘(g) INTERIM FINAL EFFECT.—The Secretary shall
publish a rule under this section in the Federal Register by not later than the target publication date.
Such rule shall be effective and final immediately on
an interim basis, but is subject to change and revision
after public notice and opportunity for a period (of not
less than 90 days) for public comment. In connection
with such rule, the Secretary shall specify the process
for the timely review and approval of applications for
such designations pursuant to such rules and consistent
with this section.
‘‘(h) PUBLICATION OF RULE AFTER PUBLIC COMMENT.—
The Secretary shall provide for consideration of such
comments and republication of such rule by not later
than 1 year after the target publication date.’’
STUDIES RELATING TO COMMUNITY HEALTH CENTERS
Pub. L. 110–355, § 2(b)(1)–(3), Oct. 8, 2008, 122 Stat. 3988,
3989, provided that:
‘‘(1) DEFINITIONS.—For purposes of this subsection—
‘‘(A) the term ‘community health center’ means a
health center receiving assistance under section 330
of the Public Health Service Act (42 U.S.C. 254b); and
‘‘(B) the term ‘medically underserved population’
has the meaning given that term in such section 330.
‘‘(2) SCHOOL-BASED HEALTH CENTER STUDY.—
‘‘(A) IN GENERAL.—Not later than 2 years after the
date of enactment of this Act [Oct. 8, 2008], the Comptroller General of the United States shall issue a
study of the economic costs and benefits of schoolbased health centers and the impact on the health of
students of these centers.
‘‘(B) CONTENT.—In conducting the study under subparagraph (A), the Comptroller General of the United
States shall analyze—
‘‘(i) the impact that Federal funding could have
on the operation of school-based health centers;
‘‘(ii) any cost savings to other Federal programs
derived from providing health services in schoolbased health centers;
‘‘(iii) the effect on the Federal Budget and the
health of students of providing Federal funds to
school-based health centers and clinics, including
the result of providing disease prevention and nutrition information;
‘‘(iv) the impact of access to health care from
school-based health centers in rural or underserved
areas; and
‘‘(v) other sources of Federal funding for schoolbased health centers.
‘‘(3) HEALTH CARE QUALITY STUDY.—
‘‘(A) IN GENERAL.—Not later than 1 year after the
date of enactment of this Act [Oct. 8, 2008], the Sec-

§ 254b

retary of Health and Human Services (referred to in
this Act [see Short Title of 2008 Amendment note set
out under section 201 of this title] as the ‘Secretary’),
acting through the Administrator of the Health Resources and Services Administration, and in collaboration with the Agency for Healthcare Research and
Quality, shall prepare and submit to the Committee
on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce
of the House of Representatives a report that describes agency efforts to expand and accelerate quality improvement activities in community health centers.
‘‘(B) CONTENT.—The report under subparagraph (A)
shall focus on—
‘‘(i) Federal efforts, as of the date of enactment of
this Act, regarding health care quality in community health centers, including quality data collection, analysis, and reporting requirements;
‘‘(ii) identification of effective models for quality
improvement in community health centers, which
may include models that—
‘‘(I) incorporate care coordination, disease management, and other services demonstrated to improve care;
‘‘(II) are designed to address multiple, co-occurring diseases and conditions;
‘‘(III) improve access to providers through nontraditional means, such as the use of remote monitoring equipment;
‘‘(IV) target various medically underserved populations, including uninsured patient populations;
‘‘(V) increase access to specialty care, including
referrals and diagnostic testing; and
‘‘(VI) enhance the use of electronic health
records to improve quality;
‘‘(iii) efforts to determine how effective quality
improvement models may be adapted for implementation by community health centers that vary by
size, budget, staffing, services offered, populations
served, and other characteristics determined appropriate by the Secretary;
‘‘(iv) types of technical assistance and resources
provided to community health centers that may facilitate the implementation of quality improvement interventions;
‘‘(v) proposed or adopted methodologies for community health center evaluations of quality improvement interventions, including any development of new measures that are tailored to safetynet, community-based providers;
‘‘(vi) successful strategies for sustaining quality
improvement interventions in the long-term; and
‘‘(vii) partnerships with other Federal agencies
and private organizations or networks as appropriate, to enhance health care quality in community health centers.
‘‘(C) DISSEMINATION.—The Administrator of the
Health Resources and Services Administration shall
establish a formal mechanism or mechanisms for the
ongoing dissemination of agency initiatives, best
practices, and other information that may assist
health care quality improvement efforts in community health centers.’’
GUARANTEE STUDY
Pub. L. 107–251, title V, § 501, Oct. 26, 2002, 116 Stat.
1664, as amended by Pub. L. 108–163, § 2(n)(2), Dec. 6,
2003, 117 Stat. 2023, provided that: ‘‘The Secretary of
Health and Human Services shall conduct a study regarding the ability of the Department of Health and
Human Services to provide for guarantees of solvency
for managed care networks or plans involving health
centers receiving funding under section 330 of the Public Health Service Act [this section]. The Secretary
shall prepare and submit a report to the appropriate
Committees of Congress regarding such ability not
later than 2 years after the date of enactment of the

§ 254b–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Health Care Safety Net Amendments of 2002 [Oct. 26,
2002].’’
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Section 4(c) of Pub. L. 104–299 provided that: ‘‘Whenever any reference is made in any provision of law, regulation, rule, record, or document to a community
health center, migrant health center, public housing
health center, or homeless health center, such reference shall be considered a reference to a health center.’’
LEGISLATIVE PROPOSAL FOR CHANGES CONFORMING TO
PUB. L. 104–299
Section 4(e) of Pub. L. 104–299 provided that: ‘‘After
consultation with the appropriate committees of the
Congress, the Secretary of Health and Human Services
shall prepare and submit to the Congress a legislative
proposal in the form of an implementing bill containing technical and conforming amendments to reflect
the changes made by this Act [see Short Title of 1996
Amendments note set out under section 201 of this
title].’’
MEDICARE DEMONSTRATION TO TEST MEDICAL HOMES IN
FEDERALLY QUALIFIED HEALTH CENTERS
Memorandum of President of the United States, Dec.
9, 2009, 74 F.R. 66207, provided:
Memorandum for the Secretary of Health And Human
Services
My Administration is committed to building a highquality, efficient health care system and improving access to health care for all Americans. Health centers
are a vital part of the health care delivery system. For
more than 40 years, health centers have served populations with limited access to health care, treating all
patients regardless of ability to pay. These include lowincome populations, the uninsured, individuals with
limited English proficiency, migrant and seasonal farm
workers, individuals and families experiencing homelessness, and individuals living in public housing. There
are over 1,100 health centers across the country, delivering care at over 7,500 sites. These centers served more
than 17 million patients in 2008 and are estimated to
serve more than 20 million patients in 2010.
The American Recovery and Reinvestment Act of 2009
(Recovery Act) provided $2 billion for health centers,
including $500 million to expand health centers’ services to over 2 million new patients by opening new
health center sites, adding new providers, and improving hours of operations. An additional $1.5 billion is
supporting much-needed capital improvements, including funding to buy equipment, modernize clinic facilities, expand into new facilities, and adopt or expand
the use of health information technology and electronic health records.
One of the key benefits health centers provide to the
communities they serve is quality primary health care
services. Health centers use interdisciplinary teams to
treat the ‘‘whole patient’’ and focus on chronic disease
management to reduce the use of costlier providers of
care, such as emergency rooms and hospitals.
Federally qualified health centers provide an excellent environment to demonstrate the further improvements to health care that may be offered by the medical homes approach. In general, this approach emphasizes the patient’s relationship with a primary care
provider who coordinates the patient’s care and serves
as the patient’s principal point of contact for care. The
medical homes approach also emphasizes activities related to quality improvement, access to care, communication with patients, and care management and coordination. These activities are expected to improve
the quality and efficiency of care and to help avoid preventable emergency and inpatient hospital care. Demonstration programs establishing the medical homes
approach have been recommended by the Medicare Pay-

Page 270

ment Advisory Commission, an independent advisory
body to the Congress.
Therefore, I direct you to implement a Medicare Federally Qualified Health Center Advanced Primary Care
Practice demonstration, pursuant to your statutory
authority to conduct experiments and demonstrations
on changes in payments and services that may improve
the quality and efficiency of services to beneficiaries.
Health centers participating in this demonstration
must have shown their ability to provide comprehensive, coordinated, integrated, and accessible health
care.
This memorandum is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other
person.
You are authorized and directed to publish this
memorandum in the Federal Register.
BARACK OBAMA.

§ 254b–1. State grants to health care providers
who provide services to a high percentage of
medically underserved populations or other
special populations
(a) In general
A State may award grants to health care providers who treat a high percentage, as determined by such State, of medically underserved
populations or other special populations in such
State.
(b) Source of funds
A grant program established by a State under
subsection (a) may not be established within a
department, agency, or other entity of such
State that administers the Medicaid program
under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.), and no Federal or State
funds allocated to such Medicaid program, the
Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), or the
TRICARE program under chapter 55 of title 10
may be used to award grants or to pay administrative costs associated with a grant program
established under subsection (a).
(Pub. L. 111–148, title V, § 5606, as added Pub. L.
111–148, title X, § 10501(k), Mar. 23, 2010, 124 Stat.
999.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII and
XIX of the Act are classified generally to subchapters
XVIII (§ 1395 et seq.) and XIX (§ 1396 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

§ 254b–2. Community health centers and the National Health Service Corps Fund
(a) Purpose
It is the purpose of this section to establish a
Community Health Center Fund (referred to in
this section as the ‘‘CHC Fund’’), to be administered through the Office of the Secretary of the
Department of Health and Human Services to

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

provide for expanded and sustained national investment in community health centers under
section 254b of this title and the National Health
Service Corps.
(b) Funding
There is authorized to be appropriated, and
there is appropriated, out of any monies in the
Treasury not otherwise appropriated, to the
CHC Fund—
(1) to be transferred to the Secretary of
Health and Human Services to provide enhanced funding for the community health center program under section 254b of this title—
(A) $1,000,000,000 for fiscal year 2011;
(B) $1,200,000,000 for fiscal year 2012;
(C) $1,500,000,000 for fiscal year 2013;
(D) $2,200,000,000 for fiscal year 2014; and
(E) $3,600,000,000 for fiscal year 2015; and
(2) to be transferred to the Secretary of
Health and Human Services to provide enhanced funding for the National Health Service Corps—
(A) $290,000,000 for fiscal year 2011;
(B) $295,000,000 for fiscal year 2012;
(C) $300,000,000 for fiscal year 2013;
(D) $305,000,000 for fiscal year 2014; and
(E) $310,000,000 for fiscal year 2015.
(c) Construction
There is authorized to be appropriated, and
there is appropriated, out of any monies in the
Treasury
not
otherwise
appropriated,
$1,500,000,000 to be available for fiscal years 2011
through 2015 to be used by the Secretary of
Health and Human Services for the construction
and renovation of community health centers.
(d) Use of fund
The Secretary of Health and Human Services
shall transfer amounts in the CHC Fund to accounts within the Department of Health and
Human Services to increase funding, over the
fiscal year 2008 level, for community health centers and the National Health Service Corps.
(e) Availability
Amounts appropriated under subsections (b)
and (c) shall remain available until expended.
(Pub. L. 111–148, title X, § 10503, Mar. 23, 2010, 124
Stat. 1004; Pub. L. 111–152, title II, § 2303, Mar. 30,
2010, 124 Stat. 1083.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (b)(1)(A). Pub. L. 111–152, § 2303(1), substituted ‘‘1,000,000,000’’ for ‘‘700,000,000’’.
Subsec. (b)(1)(B). Pub. L. 111–152, § 2303(2), substituted
‘‘1,200,000,000’’ for ‘‘800,000,000’’.
Subsec. (b)(1)(C). Pub. L. 111–152, § 2303(3), substituted
‘‘1,500,000,000’’ for ‘‘1,000,000,000’’.
Subsec. (b)(1)(D). Pub. L. 111–152, § 2303(4), substituted
‘‘2,200,000,000’’ for ‘‘1,600,000,000’’.
Subsec. (b)(1)(E). Pub. L. 111–152, § 2303(5), substituted
‘‘3,600,000,000’’ for ‘‘2,900,000,000’’.

§ 254c

§ 254c. Rural health care services outreach, rural
health network development, and small
health care provider quality improvement
grant programs
(a) Purpose
The purpose of this section is to provide
grants for expanded delivery of health care services in rural areas, for the planning and implementation of integrated health care networks in
rural areas, and for the planning and implementation of small health care provider quality improvement activities.
(b) Definitions
(1) Director
The term ‘‘Director’’ means the Director
specified in subsection (d) of this section.
(2) Federally qualified health center; rural
health clinic
The terms ‘‘Federally qualified health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in section 1395x(aa) of
this title.
(3) Health professional shortage area
The term ‘‘health professional shortage
area’’ means a health professional shortage
area designated under section 254e of this
title.
(4) Medically underserved community
The term ‘‘medically underserved community’’ has the meaning given the term in section 295p(6) of this title.
(5) Medically underserved population
The term ‘‘medically underserved population’’ has the meaning given the term in section 254b(b)(3) of this title.
(c) Program
The Secretary shall establish, under section
241 of this title, a small health care provider
quality improvement grant program.
(d) Administration
(1) Programs
The rural health care services outreach,
rural health network development, and small
health care provider quality improvement
grant programs established under section 241
of this title shall be administered by the Director of the Office of Rural Health Policy of
the Health Resources and Services Administration, in consultation with State offices of
rural health or other appropriate State government entities.
(2) Grants
(A) In general
In carrying out the programs described in
paragraph (1), the Director may award
grants under subsections (e), (f), and (g) of
this section to expand access to, coordinate,
and improve the quality of essential health
care services, and enhance the delivery of
health care, in rural areas.
(B) Types of grants
The Director may award the grants—
(i) to promote expanded delivery of
health care services in rural areas under
subsection (e) of this section;

§ 254c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) to provide for the planning and implementation of integrated health care
networks in rural areas under subsection
(f) of this section; and
(iii) to provide for the planning and implementation of small health care provider
quality improvement activities under subsection (g) of this section.
(e) Rural health care services outreach grants
(1) Grants
The Director may award grants to eligible
entities to promote rural health care services
outreach by expanding the delivery of health
care services to include new and enhanced
services in rural areas. The Director may
award the grants for periods of not more than
3 years.
(2) Eligibility
To be eligible to receive a grant under this
subsection for a project, an entity—
(A) shall be a rural public or rural nonprofit private entity;
(B) shall represent a consortium composed
of members—
(i) that include 3 or more health care
providers; and
(ii) that may be nonprofit or for-profit
entities; and
(C) shall not previously have received a
grant under this subsection for the same or
a similar project, unless the entity is proposing to expand the scope of the project or
the area that will be served through the
project.
(3) Applications
To be eligible to receive a grant under this
subsection, an eligible entity, in consultation
with the appropriate State office of rural
health or another appropriate State entity,
shall prepare and submit to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary
may require, including—
(A) a description of the project that the eligible entity will carry out using the funds
provided under the grant;
(B) a description of the manner in which
the project funded under the grant will meet
the health care needs of rural underserved
populations in the local community or region to be served;
(C) a description of how the local community or region to be served will be involved
in the development and ongoing operations
of the project;
(D) a plan for sustaining the project after
Federal support for the project has ended;
(E) a description of how the project will be
evaluated; and
(F) other such information as the Secretary determines to be appropriate.
(f) Rural health network development grants
(1) Grants
(A) In general
The Director may award rural health network development grants to eligible entities
to promote, through planning and imple-

Page 272

mentation, the development of integrated
health care networks that have combined
the functions of the entities participating in
the networks in order to—
(i) achieve efficiencies;
(ii) expand access to, coordinate, and improve the quality of essential health care
services; and
(iii) strengthen the rural health care system as a whole.
(B) Grant periods
The Director may award such a rural
health network development grant for implementation activities for a period of 3
years. The Director may also award such a
rural health network development grant for
planning activities for a period of 1 year, to
assist in the development of an integrated
health care network, if the proposed participants in the network do not have a history
of collaborative efforts and a 3-year grant
would be inappropriate.
(2) Eligibility
To be eligible to receive a grant under this
subsection, an entity—
(A) shall be a rural public or rural nonprofit private entity;
(B) shall represent a network composed of
participants—
(i) that include 3 or more health care
providers; and
(ii) that may be nonprofit or for-profit
entities; and
(C) shall not previously have received a
grant under this subsection (other than a
grant for planning activities) for the same or
a similar project.
(3) Applications
To be eligible to receive a grant under this
subsection, an eligible entity, in consultation
with the appropriate State office of rural
health or another appropriate State entity,
shall prepare and submit to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary
may require, including—
(A) a description of the project that the eligible entity will carry out using the funds
provided under the grant;
(B) an explanation of the reasons why Federal assistance is required to carry out the
project;
(C) a description of—
(i) the history of collaborative activities
carried out by the participants in the network;
(ii) the degree to which the participants
are ready to integrate their functions; and
(iii) how the local community or region
to be served will benefit from and be involved in the activities carried out by the
network;
(D) a description of how the local community or region to be served will experience
increased access to quality health care services across the continuum of care as a result
of the integration activities carried out by
the network;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(E) a plan for sustaining the project after
Federal support for the project has ended;
(F) a description of how the project will be
evaluated; and
(G) other such information as the Secretary determines to be appropriate.
(g) Small health care provider quality improvement grants
(1) Grants
The Director may award grants to provide
for the planning and implementation of small
health care provider quality improvement activities. The Director may award the grants
for periods of 1 to 3 years.
(2) Eligibility
To be eligible for a grant under this subsection, an entity—
(A)(i) shall be a rural public or rural nonprofit private health care provider or provider of health care services, such as a critical access hospital or a rural health clinic;
or
(ii) shall be another rural provider or network of small rural providers identified by
the Secretary as a key source of local care;
and
(B) shall not previously have received a
grant under this subsection for the same or
a similar project.
(3) Applications
To be eligible to receive a grant under this
subsection, an eligible entity, in consultation
with the appropriate State office of rural
health or another appropriate State entity
shall prepare and submit to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary
may require, including—
(A) a description of the project that the eligible entity will carry out using the funds
provided under the grant;
(B) an explanation of the reasons why Federal assistance is required to carry out the
project;
(C) a description of the manner in which
the project funded under the grant will assure continuous quality improvement in the
provision of services by the entity;
(D) a description of how the local community or region to be served will experience
increased access to quality health care services across the continuum of care as a result
of the activities carried out by the entity;
(E) a plan for sustaining the project after
Federal support for the project has ended;
(F) a description of how the project will be
evaluated; and
(G) other such information as the Secretary determines to be appropriate.
(4) Expenditures for small health care provider
quality improvement grants
In awarding a grant under this subsection,
the Director shall ensure that the funds made
available through the grant will be used to
provide services to residents of rural areas.
The Director shall award not less than 50 percent of the funds made available under this
subsection to providers located in and serving
rural areas.

§ 254c

(h) General requirements
(1) Prohibited uses of funds
An entity that receives a grant under this
section may not use funds provided through
the grant—
(A) to build or acquire real property; or
(B) for construction.
(2) Coordination with other agencies
The Secretary shall coordinate activities
carried out under grant programs described in
this section, to the extent practicable, with
Federal and State agencies and nonprofit organizations that are operating similar grant
programs, to maximize the effect of public dollars in funding meritorious proposals.
(3) Preference
In awarding grants under this section, the
Secretary shall give preference to entities
that—
(A) are located in health professional
shortage areas or medically underserved
communities, or serve medically underserved populations; or
(B) propose to develop projects with a
focus on primary care, and wellness and prevention strategies.
(i) Report
Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate committees of Congress a report on the
progress and accomplishments of the grant programs described in subsections (e), (f), and (g) of
this section.
(j) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $45,000,000 for each of fiscal years 2008 through 2012.
(July 1, 1944, ch. 373, title III, § 330A, as added
Pub. L. 104–299, § 3(a), Oct. 11, 1996, 110 Stat. 3642;
amended Pub. L. 107–251, title II, § 201, Oct. 26,
2002, 116 Stat. 1628; Pub. L. 108–163, § 2(b), Dec. 6,
2003, 117 Stat. 2021; Pub. L. 110–355, § 4, Oct. 8,
2008, 122 Stat. 3994.)
PRIOR PROVISIONS
A prior section 254c, act July 1, 1944, ch. 373, title III,
§ 330, as added July 29, 1975, Pub. L. 94–63, title V,
§ 501(a), 89 Stat. 342; amended Apr. 22, 1976, Pub. L.
94–278, title VIII, § 801(b), 90 Stat. 415; Aug. 1, 1977, Pub.
L. 95–83, title III, § 304, 91 Stat. 388; Nov. 10, 1978, Pub.
L. 95–626, title I, § 104(a)–(d)(3)(B), (4), (5), (e), (f), 92
Stat. 3556–3559; July 10, 1979, Pub. L. 96–32, §§ 6(b)–(d),
7(c), 93 Stat. 83, 84; Oct. 17, 1979, Pub. L. 96–88, title V,
§ 509(b), 93 Stat. 695; Oct. 19, 1980, Pub. L. 96–470, title I,
§ 106(e), 94 Stat. 2238; Aug. 13, 1981, Pub. L. 97–35, title
IX, §§ 903(a), 905, 906, 95 Stat. 561, 562; Jan. 4, 1983, Pub.
L. 97–414, § 8(e), 96 Stat. 2060; Apr. 24, 1986, Pub. L.
99–280, §§ 2–4, 100 Stat. 399, 400; Aug. 10, 1988, Pub. L.
100–386, §§ 3, 4, 102 Stat. 921, 923; Nov. 4, 1988, Pub. L.
100–607, title I, § 163(3), 102 Stat. 3062; Dec. 19, 1989, Pub.
L. 101–239, title VI, § 6103(e)(5), 103 Stat. 2207; Nov. 6,
1990, Pub. L. 101–527, § 9(a), 104 Stat. 2332; Oct. 27, 1992,
Pub. L. 102–531, title III, § 309(b), 106 Stat. 3500, related
to community health centers, prior to the general
amendment of this subpart by Pub. L. 104–299, § 2.
AMENDMENTS
2008—Subsec. (j). Pub. L. 110–355 substituted
‘‘$45,000,000 for each of fiscal years 2008 through 2012.’’
for ‘‘$40,000,000 for fiscal year 2002, and such sums as

§ 254c–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

may be necessary for each of fiscal years 2003 through
2006.’’
2003—Subsec. (b)(4). Pub. L. 108–163 substituted ‘‘section 295p(6)’’ for ‘‘section 295p’’.
2002—Pub. L. 107–251 amended section generally. Prior
to amendment, section related to a rural health outreach, network development, and telemedicine grant
program, and in subsec. (a), provided for administration
by the Office of Rural Health Policy; in subsec. (b), set
out the objectives of grants; in subsec. (c), set out eligibility requirements; in subsec. (d), described preferred
characteristics of applicant networks; in subsec. (e),
specified permitted uses of grant funds; in subsec. (f),
limited the duration of grants; and in subsec. (g), authorized appropriations.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1996, see section 5 of Pub. L.
104–299, as amended, set out as an Effective Date of 1996
Amendment note under section 233 of this title.
RURAL ACCESS TO EMERGENCY DEVICES
Pub. L. 106–505, title IV, subtitle B, Nov. 13, 2000, 114
Stat. 2340, provided that:
‘‘SEC. 411. SHORT TITLE.
‘‘This subtitle may be cited as the ‘Rural Access to
Emergency Devices Act’ or the ‘Rural AED Act’.
‘‘SEC. 412. FINDINGS.
‘‘Congress makes the following findings:
‘‘(1) Heart disease is the leading cause of death in
the United States.
‘‘(2) The American Heart Association estimates
that 250,000 Americans die from sudden cardiac arrest
each year.
‘‘(3) A cardiac arrest victim’s chance of survival
drops 10 percent for every minute that passes before
his or her heart is returned to normal rhythm.
‘‘(4) Because most cardiac arrest victims are initially in ventricular fibrillation, and the only treatment for ventricular fibrillation is defibrillation,
prompt access to defibrillation to return the heart to
normal rhythm is essential.
‘‘(5) Lifesaving technology, the automated external
defibrillator, has been developed to allow trained lay
rescuers to respond to cardiac arrest by using this
simple device to shock the heart into normal rhythm.
‘‘(6) Those people who are likely to be first on the
scene of a cardiac arrest situation in many communities, particularly smaller and rural communities,
lack sufficient numbers of automated external defibrillators to respond to cardiac arrest in a timely
manner.
‘‘(7) The American Heart Association estimates
that more than 50,000 deaths could be prevented each
year if defibrillators were more widely available to
designated responders.
‘‘(8) Legislation should be enacted to encourage
greater public access to automated external defibrillators in communities across the United States.
‘‘SEC. 413. GRANTS.
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Rural Health Outreach Office of the Health Resources and Services Administration, shall award grants to community partnerships that meet the requirements of subsection (b)
to enable such partnerships to purchase equipment and
provide training as provided for in subsection (c).
‘‘(b) COMMUNITY PARTNERSHIPS.—A community partnership meets the requirements of this subsection if
such partnership—
‘‘(1) is composed of local emergency response entities such as community training facilities, local

Page 274

emergency responders, fire and rescue departments,
police, community hospitals, and local non-profit entities and for-profit entities concerned about cardiac
arrest survival rates;
‘‘(2) evaluates the local community emergency response times to assess whether they meet the standards established by national public health organizations such as the American Heart Association and the
American Red Cross; and
‘‘(3) submits to the Secretary of Health and Human
Services an application at such time, in such manner,
and containing such information as the Secretary
may require.
‘‘(c) USE OF FUNDS.—Amounts provided under a grant
under this section shall be used—
‘‘(1) to purchase automated external defibrillators
that have been approved, or cleared for marketing, by
the Food and Drug Administration; and
‘‘(2) to provide defibrillator and basic life support
training in automated external defibrillator usage
through the American Heart Association, the American Red Cross, or other nationally recognized training courses.
‘‘(d) REPORT.—Not later than 4 years after the date of
the enactment of this Act [Nov. 13, 2000], the Secretary
of Health and Human Services shall prepare and submit
to the appropriate committees of Congress a report
containing data relating to whether the increased
availability of defibrillators has affected survival rates
in the communities in which grantees under this section operated. The procedures under which the Secretary obtains data and prepares the report under this
subsection shall not impose an undue burden on program participants under this section.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $25,000,000 for fiscal years
2001 through 2003 to carry out this section.’’
REPORT ON TELEMEDICINE
Pub. L. 106–129, § 6, Dec. 6, 1999, 113 Stat. 1675, provided
that: ‘‘Not later than January 10, 2001, the Secretary of
Health and Human Services shall submit to the Congress a report that—
‘‘(1) identifies any factors that inhibit the expansion and accessibility of telemedicine services, including factors relating to telemedicine networks;
‘‘(2) identifies any factors that, in addition to geographical isolation, should be used to determine
which patients need or require access to telemedicine
care;
‘‘(3) determines the extent to which—
‘‘(A) patients receiving telemedicine service have
benefited from the services, and are satisfied with
the treatment received pursuant to the services;
and
‘‘(B) the medical outcomes for such patients
would have differed if telemedicine services had not
been available to the patients;
‘‘(4) determines the extent to which physicians involved with telemedicine services have been satisfied
with the medical aspects of the services;
‘‘(5) determines the extent to which primary care
physicians are enhancing their medical knowledge
and experience through the interaction with specialists provided by telemedicine consultations; and
‘‘(6) identifies legal and medical issues relating to
State licensing of health professionals that are presented by telemedicine services, and provides any
recommendations of the Secretary for responding to
such issues.’’

§ 254c–1. Grants for health services for Pacific Islanders
(a) Grants
The Secretary of Health and Human Services
(hereafter in this section referred to as the
‘‘Secretary’’) shall provide grants to, or enter
into contracts with, public or private nonprofit

Page 275

TITLE 42—THE PUBLIC HEALTH AND WELFARE

agencies that have demonstrated experience in
serving the health needs of Pacific Islanders living in the Territory of American Samoa, the
Commonwealth of Northern Mariana Islands,
the Territory of Guam, the Republic of the Marshall Islands, the Republic of Palau, and the
Federated States of Micronesia.
(b) Use of grants or contracts
Grants or contracts made or entered into
under subsection (a) of this section shall be
used, among other items—
(1) to continue, as a priority, the medical officer training program in Pohnpei, Federated
States of Micronesia;
(2) to improve the quality and availability of
health and mental health services and systems, with an emphasis therein on preventive
health services and health promotion programs and projects, including improved health
data systems;
(3) to improve the quality and availability of
health manpower, including programs and
projects to train new and upgrade the skills of
existing health professionals by—
(A) establishing dental officer, dental assistant, nurse practitioner, or nurse clinical
specialist training programs;
(B) providing technical training of new
auxiliary health workers;
(C) upgrading the training of currently
employed health personnel in special areas
of need;
(D) developing long-term plans for meeting
health profession needs;
(E) developing or improving programs for
faculty enhancement or post-doctoral training; and
(F) providing innovative health professions
training initiatives (including scholarships)
targeted toward ensuring that residents of
the Pacific Basin attend and graduate from
recognized health professional programs;

§ 254c–1a

resenting organizations in the State of Hawaii
actively involved in the provision of health
services or technical assistance to the entities
identified in subsection (a) of this section. The
Secretary shall solicit the advice of the Governor of the State of Hawaii in appointing the
5 Council members in addition to the representative of the Rehabilitation Hospital of
the Pacific from the State of Hawaii.
The Secretary shall be responsible for providing
sufficient staff support to the Council.
(d) Advisory Council functions
The Council shall meet at least annually to—
(1) recommend priority areas of need for
funding by the Public Health Service under
this section; and
(2) review progress in addressing priority
areas and make recommendations to the Secretary for needed program modifications.
(e) Omitted
(f) Authorization of appropriation
There is authorized to be appropriated to
carry out this section $10,000,000 for each of the
fiscal years 1991 through 1993.
(Pub. L. 101–527, § 10, Nov. 6, 1990, 104 Stat. 2333.)
CODIFICATION
Section was enacted as part of the Disadvantaged Minority Health Improvement Act of 1990, and not as part
of the Public Health Service Act which comprises this
chapter.
Subsec. (e) of this section, which required the Secretary, in consultation with the Council, to annually
prepare and submit to appropriate committees of Congress a report describing the expenditure of funds authorized to be appropriated under this section, with
any recommendations of the Secretary, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L.
104–66, as amended, set out as a note under section 1113
of Title 31, Money and Finance. See, also, page 95 of
House Document No. 103–7.

(4) to improve the quality of health services,
including laboratory, x-ray, and pharmacy,
provided in ambulatory and inpatient settings
through quality assurance, standard setting,
and other culturally appropriate means;
(5) to improve facility and equipment repair
and maintenance systems;
(6) to improve alcohol, drug abuse, and mental health prevention and treatment services
and systems;
(7) to improve local and regional health
planning systems; and
(8) to improve basic local public health systems, with particular attention to primary
care and services to those most in need.

§ 254c–1a. Grants to nurse-managed health clinics

No funds under subsection (b) of this section
shall be used for capital construction.
(c) Advisory Council
The Secretary of Health and Human Services
shall establish a ‘‘Pacific Health Advisory Council’’ which shall consist of 12 members and shall
include—
(1) the Directors of the Health Departments
for the entities identified in subsection (a) of
this section; and
(2) 6 members, including a representative of
the Rehabilitation Hospital of the Pacific, rep-

(a) Definitions
(1) Comprehensive primary health care services
In this section, the term ‘‘comprehensive
primary health care services’’ means the primary health services described in section
254b(b)(1) of this title.
(2) Nurse-managed health clinic
The term ‘‘nurse-managed health clinic’’
means a nurse-practice arrangement, managed
by advanced practice nurses, that provides pri-

TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.

§ 254c–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mary care or wellness services to underserved
or vulnerable populations and that is associated with a school, college, university or department of nursing, federally qualified health
center, or independent nonprofit health or social services agency.
(b) Authority to award grants
The Secretary shall award grants for the cost
of the operation of nurse-managed health clinics
that meet the requirements of this section.
(c) Applications
To be eligible to receive a grant under this
section, an entity shall—
(1) be an NMHC; and
(2) submit to the Secretary an application at
such time, in such manner, and containing—
(A) assurances that nurses are the major
providers of services at the NMHC and that
at least 1 advanced practice nurse holds an
executive management position within the
organizational structure of the NMHC;
(B) an assurance that the NMHC will continue providing comprehensive primary
health care services or wellness services
without regard to income or insurance
status of the patient for the duration of the
grant period; and
(C) an assurance that, not later than 90
days of receiving a grant under this section,
the NMHC will establish a community advisory committee, for which a majority of the
members shall be individuals who are served
by the NMHC.
(d) Grant amount
The amount of any grant made under this section for any fiscal year shall be determined by
the Secretary, taking into account—
(1) the financial need of the NMHC, considering State, local, and other operational funding
provided to the NMHC; and
(2) other factors, as the Secretary determines appropriate.
(e) Authorization of appropriations
For the purposes of carrying out this section,
there are authorized to be appropriated
$50,000,000 for the fiscal year 2010 and such sums
as may be necessary for each of the fiscal years
2011 through 2014.
(July 1, 1944, ch. 373, title III, § 330A–1, as added
Pub. L. 111–148, title V, § 5208(b), Mar. 23, 2010, 124
Stat. 613.)

Page 276

section for each of fiscal years 1998 through
2002, $30,000,000 is hereby transferred and made
available in such fiscal year for grants under
this section.
(2) Appropriations
For the purpose of making grants under this
section, there is appropriated, out of any funds
in the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001
and 2002 (which shall be combined with
amounts transferred under paragraph (1) for
each such fiscal years);
(B) $100,000,000 for fiscal year 2003; and
(C) $150,000,000 for each of fiscal years 2004
through 2013.
(July 1, 1944, ch. 373, title III, § 330B, as added
Pub. L. 105–33, title IV, § 4921, Aug. 5, 1997, 111
Stat. 574; amended Pub. L. 105–34, title XVI,
§ 1604(f)(1)(B), (C), Aug. 5, 1997, 111 Stat. 1098;
Pub. L. 106–554, § 1(a)(6) [title IX, § 931(a)], Dec.
21, 2000, 114 Stat. 2763, 2763A–585; Pub. L. 107–360,
§ 1(a), Dec. 17, 2002, 116 Stat. 3019; Pub. L. 110–173,
title III, § 302(a), Dec. 29, 2007, 121 Stat. 2514; Pub.
L. 110–275, title III, § 303(a), July 15, 2008, 122
Stat. 2594; Pub. L. 111–309, title I, § 112(1), Dec. 15,
2010, 124 Stat. 3289.)
AMENDMENTS
2010—Subsec. (b)(2)(C). Pub. L. 111–309 substituted
‘‘2013’’ for ‘‘2011’’.
2008—Subsec. (b)(2)(C). Pub. L. 110–275 substituted
‘‘2011’’ for ‘‘2009’’.
2007—Subsec. (b)(2)(C). Pub. L. 110–173 substituted
‘‘2009’’ for ‘‘2008’’.
2002—Subsec. (b)(2)(C). Pub. L. 107–360 added subpar.
(C).
2000—Subsec. (b). Pub. L. 106–554 designated existing
provisions as par. (1), inserted par. heading, and added
par. (2).
1997—Pub. L. 105–34, § 1604(f)(1)(B), amended directory
language of Pub. L. 105–33, § 4921, which enacted this
section.
Pub. L. 105–34, § 1604(f)(1)(C)(i), struck out ‘‘children
with’’ before ‘‘type I diabetes’’ in section catchline.
Subsec. (a). Pub. L. 105–34, § 1604(f)(1)(C)(ii), amended
heading and text of subsec. (a) generally. Prior to
amendment, text read as follows: ‘‘The Secretary shall
make grants for services for the prevention and treatment of type I diabetes in children, and for research in
innovative approaches to such services. Such grants
may be made to children’s hospitals; grantees under
section 254b of this title and other federally qualified
health centers; State and local health departments; and
other appropriate public or nonprofit private entities.’’

PURPOSE

EFFECTIVE DATE OF 1997 AMENDMENT

Pub. L. 111–148, title V, § 5208(a), Mar. 23, 2010, 124
Stat. 612, provided that: ‘‘The purpose of this section
[enacting this section] is to fund the development and
operation of nurse-managed health clinics.’’

Section 1604(f)(4) of Pub. L. 105–34 provided that: ‘‘The
provisions of, and amendments made by, this subsection [amending this section and provisions set out
as a note under section 5701 of Title 26, Internal Revenue Code] shall take effect immediately after the sections referred to in this subsection [sections 4921, 9302,
11104, and 11201 of Pub. L. 105–33] take effect.’’

§ 254c–2. Special diabetes programs for type I diabetes
(a) In general
The Secretary, directly or through grants,
shall provide for research into the prevention
and cure of Type 1 I diabetes.
(b) Funding
(1) Transferred funds
Notwithstanding section 1397dd(a) of this
title, from the amounts appropriated in such
1 So

in original. Probably should not be capitalized.

REPORT ON DIABETES GRANT PROGRAMS
Pub. L. 105–33, title IV, § 4923, Aug. 5, 1997, 111 Stat.
574, as amended by Pub. L. 106–554, § 1(a)(6) [title IX,
§ 931(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–585; Pub. L.
107–360, § 1(c), Dec. 17, 2002, 116 Stat. 3019; Pub. L.
109–482, title I, § 104(b)(3)(C), Jan. 15, 2007, 120 Stat. 3694;
Pub. L. 110–275, title III, § 303(c), July 15, 2008, 122 Stat.
2594, provided that:
‘‘(a) EVALUATION.—The Secretary of Health and
Human Services shall conduct an evaluation of the diabetes grant programs established under the amend-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ments made by this chapter [chapter 3 (§§ 4921–4923) of
subtitle J of title IV of Pub. L. 105–33, enacting this section and section 254c–3 of this title].
‘‘[(b) Repealed. Pub. L. 109–482, title I, § 104(b)(3)(C),
Jan. 15, 2007, 120 Stat. 3694.]’’
[Pub. L. 110–275, § 303(c), which directed amendment of
section 4923(b) of Pub. L. 105–33 by substituting ‘‘a second interim report’’ for ‘‘a final report’’ in par. (2) and
by adding par. (3) at end to read ‘‘a report on such evaluation not later than January 1, 2011.’’, could not be executed because of prior repeal.]

§ 254c–3. Special diabetes programs for Indians
(a) In general
The Secretary shall make grants for providing
services for the prevention and treatment of diabetes in accordance with subsection (b) of this
section.
(b) Services through Indian health facilities
For purposes of subsection (a) of this section,
services under such subsection are provided in
accordance with this subsection if the services
are provided through any of the following entities:
(1) The Indian Health Service.
(2) An Indian health program operated by an
Indian tribe or tribal organization pursuant to
a contract, grant, cooperative agreement, or
compact with the Indian Health Service pursuant to the Indian Self-Determination Act [25
U.S.C. 450f et seq.].
(3) An urban Indian health program operated
by an urban Indian organization pursuant to a
grant or contract with the Indian Health Service pursuant to title V of the Indian Health
Care Improvement Act [25 U.S.C. 1651 et seq.].
(c) Funding
(1) Transferred funds
Notwithstanding section 1397dd(a) of this
title, from the amounts appropriated in such
section for each of fiscal years 1998 through
2002, $30,000,000, to remain available until expended, is hereby transferred and made available in such fiscal year for grants under this
section.
(2) Appropriations
For the purpose of making grants under this
section, there is appropriated, out of any
money in the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001
and 2002 (which shall be combined with
amounts transferred under paragraph (1) for
each such fiscal years);
(B) $100,000,000 for fiscal year 2003; and
(C) $150,000,000 for each of fiscal years 2004
through 2013.

§ 254c–4

Stat. 2206, as amended, which is classified principally
to part A (§ 450f et seq.) of subchapter II of chapter 14
of Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.
The Indian Health Care Improvement Act, referred to
in subsec. (b)(3), is Pub. L. 94–437, Sept. 30, 1976, 90 Stat.
1400, as amended. Title V of the Act is classified generally to subchapter IV (§ 1651 et seq.) of chapter 18 of
Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables.
AMENDMENTS
2010—Subsec. (c)(2)(C). Pub. L. 111–309 substituted
‘‘2013’’ for ‘‘2011’’.
2008—Subsec. (c)(2)(C). Pub. L. 110–275 substituted
‘‘2011’’ for ‘‘2009’’.
2007—Subsec. (c)(2)(C). Pub. L. 110–173 substituted
‘‘2009’’ for ‘‘2008’’.
2002—Subsec. (c)(2)(C). Pub. L. 107–360 added subpar.
(C).
2000—Subsec. (c). Pub. L. 106–554 designated existing
provisions as par. (1), inserted par. heading, and added
par. (2).
1998—Subsec. (c). Pub. L. 105–174 inserted ‘‘, to remain available until expended,’’ after ‘‘fiscal years 1998
through 2002, $30,000,000’’.
FUNDS AVAILABLE UNTIL EXPENDED
Pub. L. 108–7, div. F, title II, Feb. 20, 2003, 117 Stat.
261, provided in part ‘‘That funds appropriated under
the Special Diabetes Program for Indians (42 U.S.C.
254c–3(c)) for fiscal year 2003 and thereafter for the purpose of making grants shall remain available until expended’’.

§ 254c–4. Centers for strategies on facilitating utilization of preventive health services among
various populations

REFERENCES IN TEXT

(a) In general
The Secretary, acting through the appropriate
agencies of the Public Health Service, shall
make grants to public or nonprofit private entities for the establishment and operation of regional centers whose purpose is to develop,
evaluate, and disseminate effective strategies,
which utilize quality management measures, to
assist public and private health care programs
and providers in the appropriate utilization of
preventive health care services by specific populations.
(b) Research and training
The activities carried out by a center under
subsection (a) of this section may include establishing programs of research and training with
respect to the purpose described in such subsection, including the development of curricula
for training individuals in implementing the
strategies developed under such subsection.
(c) Priority regarding infants and children
In carrying out the purpose described in subsection (a) of this section, the Secretary shall
give priority to various populations of infants,
young children, and their mothers.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2000 through 2004.

The Indian Self-Determination Act, referred to in
subsec. (b)(2), is title I of Pub. L. 93–638, Jan. 4, 1975, 88

(July 1, 1944, ch. 373, title III, § 330D, as added
Pub. L. 106–129, § 3, Dec. 6, 1999, 113 Stat. 1670.)

(July 1, 1944, ch. 373, title III, § 330C, as added
Pub. L. 105–33, title IV, § 4922, Aug. 5, 1997, 111
Stat. 574; amended Pub. L. 105–174, title III,
§ 3001, May 1, 1998, 112 Stat. 82; Pub. L. 106–554,
§ 1(a)(6) [title IX, § 931(b)], Dec. 21, 2000, 114 Stat.
2763, 2763A–585; Pub. L. 107–360, § 1(b), Dec. 17,
2002, 116 Stat. 3019; Pub. L. 110–173, title III,
§ 302(b), Dec. 29, 2007, 121 Stat. 2515; Pub. L.
110–275, title III, § 303(b), July 15, 2008, 122 Stat.
2594; Pub. L. 111–309, title I, § 112(2), Dec. 15, 2010,
124 Stat. 3289.)

§ 254c–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 254c–5. Epilepsy; seizure disorder
(a) National public health campaign
(1) In general
The Secretary shall develop and implement
public health surveillance, education, research, and intervention strategies to improve
the lives of persons with epilepsy, with a particular emphasis on children. Such projects
may be carried out by the Secretary directly
and through awards of grants or contracts to
public or nonprofit private entities. The Secretary may directly or through such awards
provide technical assistance with respect to
the planning, development, and operation of
such projects.
(2) Certain activities
Activities under paragraph (1) shall include—
(A) expanding current surveillance activities through existing monitoring systems
and improving registries that maintain data
on individuals with epilepsy, including children;
(B) enhancing research activities on the
diagnosis, treatment, and management of
epilepsy;
(C) implementing public and professional
information and education programs regarding epilepsy, including initiatives which promote effective management of the disease
through children’s programs which are targeted to parents, schools, daycare providers,
patients;
(D) undertaking educational efforts with
the media, providers of health care, schools
and others regarding stigmas and secondary
disabilities related to epilepsy and seizures,
and its effects on youth;
(E) utilizing and expanding partnerships
with organizations with experience addressing the health and related needs of people
with disabilities; and
(F) other activities the Secretary deems
appropriate.
(3) Coordination of activities
The Secretary shall ensure that activities
under this subsection are coordinated as appropriate with other agencies of the Public
Health Service that carry out activities regarding epilepsy and seizure.
(b) Seizure disorder; demonstration projects in
medically underserved areas
(1) In general
The Secretary, acting through the Administrator of the Health Resources and Services
Administration, may make grants for the purpose of carrying out demonstration projects to
improve access to health and other services regarding seizures to encourage early detection
and treatment in children and others residing
in medically underserved areas.
(2) Application for grant
A grant may not be awarded under paragraph (1) unless an application therefore is
submitted to the Secretary and the Secretary
approves such application. Such application
shall be submitted in such form and manner

Page 278

and shall contain such information as the Secretary may prescribe.
(c) Definitions
For purposes of this section:
(1) The term ‘‘epilepsy’’ refers to a chronic
and serious neurological condition characterized by excessive electrical discharges in the
brain causing recurring seizures affecting all
life activities. The Secretary may revise the
definition of such term to the extent the Secretary determines necessary.
(2) The term ‘‘medically underserved’’ has
the meaning applicable under section 295p(6) of
this title.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 330E, as added
Pub. L. 106–310, div. A, title VIII, § 801, Oct. 17,
2000, 114 Stat. 1124.)
§ 254c–6. Certain services for pregnant women
(a) Infant adoption awareness
(1) In general
The Secretary shall make grants to national, regional, or local adoption organizations for the purpose of developing and implementing programs to train the designated
staff of eligible health centers in providing
adoption information and referrals to pregnant women on an equal basis with all other
courses of action included in nondirective
counseling to pregnant women.
(2) Best-practices guidelines
(A) In general
A condition for the receipt of a grant
under paragraph (1) is that the adoption organization involved agree that, in providing
training under such paragraph, the organization will follow the guidelines developed
under subparagraph (B).
(B) Process for development of guidelines
(i) In general
The Secretary shall establish and supervise a process described in clause (ii) in
which the participants are—
(I) an appropriate number and variety
of adoption organizations that, as a
group, have expertise in all models of
adoption practice and that represent all
members of the adoption triad (birth
mother, infant, and adoptive parent);
and
(II) affected public health entities.
(ii) Description of process
The process referred to in clause (i) is a
process in which the participants described
in such clause collaborate to develop bestpractices guidelines on the provision of
adoption information and referrals to
pregnant women on an equal basis with all
other courses of action included in nondirective counseling to pregnant women.
(iii) Date certain for development
The Secretary shall ensure that the
guidelines described in clause (ii) are de-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

veloped not later than 180 days after October 17, 2000.
(C) Relation to authority for grants
The Secretary may not make any grant
under paragraph (1) before the date on which
the guidelines under subparagraph (B) are
developed.
(3) Use of grant
(A) In general
With respect to a grant under paragraph
(1)—
(i) an adoption organization may expend
the grant to carry out the programs directly or through grants to or contracts
with other adoption organizations;
(ii) the purposes for which the adoption
organization expends the grant may include the development of a training curriculum, consistent with the guidelines developed under paragraph (2)(B); and
(iii) a condition for the receipt of the
grant is that the adoption organization
agree that, in providing training for the
designated staff of eligible health centers,
such organization will make reasonable efforts to ensure that the individuals who
provide the training are individuals who
are knowledgeable in all elements of the
adoption process and are experienced in
providing adoption information and referrals in the geographic areas in which the
eligible health centers are located, and
that the designated staff receive the training in such areas.
(B) Rule of construction regarding training
of trainers
With respect to individuals who under a
grant under paragraph (1) provide training
for the designated staff of eligible health
centers (referred to in this subparagraph as
‘‘trainers’’), subparagraph (A)(iii) may not
be construed as establishing any limitation
regarding the geographic area in which the
trainers receive instruction in being such
trainers. A trainer may receive such instruction in a different geographic area than the
area in which the trainer trains (or will
train) the designated staff of eligible health
centers.
(4) Adoption organizations; eligible health centers; other definitions
For purposes of this section:
(A) The term ‘‘adoption organization’’
means a national, regional, or local organization—
(i) among whose primary purposes are
adoption;
(ii) that is knowledgeable in all elements
of the adoption process and on providing
adoption information and referrals to
pregnant women; and
(iii) that is a nonprofit private entity.
(B) The term ‘‘designated staff’’, with respect to an eligible health center, means
staff of the center who provide pregnancy or
adoption information and referrals (or will
provide such information and referrals after
receiving training under a grant under paragraph (1)).

§ 254c–6

(C) The term ‘‘eligible health centers’’
means public and nonprofit private entities
that provide health services to pregnant
women.
(5) Training for certain eligible health centers
A condition for the receipt of a grant under
paragraph (1) is that the adoption organization
involved agree to make reasonable efforts to
ensure that the eligible health centers with respect to which training under the grant is provided include—
(A) eligible health centers that receive
grants under section 300 of this title (relating to voluntary family planning projects);
(B) eligible health centers that receive
grants under section 254b of this title (relating to community health centers, migrant
health centers, and centers regarding homeless individuals and residents of public housing); and
(C) eligible health centers that receive
grants under this chapter for the provision
of services in schools.
(6) Participation of certain eligible health clinics
In the case of eligible health centers that receive grants under section 254b or 300 of this
title:
(A) Within a reasonable period after the
Secretary begins making grants under paragraph (1), the Secretary shall provide eligible health centers with complete information about the training available from organizations receiving grants under such paragraph. The Secretary shall make reasonable
efforts to encourage eligible health centers
to arrange for designated staff to participate
in such training. Such efforts shall affirm
Federal requirements, if any, that the eligible health center provide nondirective counseling to pregnant women.
(B) All costs of such centers in obtaining
the training shall be reimbursed by the organization that provides the training, using
grants under paragraph (1).
(C) Not later than 1 year after October 17,
2000, the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption
information and referral, upon request, are
provided by eligible health centers. Within a
reasonable time after training under this
section is initiated, the Secretary shall submit to the appropriate committees of the
Congress a report evaluating the extent to
which adoption information and referral,
upon request, are provided by eligible health
centers in order to determine the effectiveness of such training and the extent to
which such training complies with subsection (a)(1) of this section. In preparing
the reports required by this subparagraph,
the Secretary shall in no respect interpret
the provisions of this section to allow any
interference in the provider-patient relationship, any breach of patient confidentiality,
or any monitoring or auditing of the counseling process or patient records which
breaches patient confidentiality or reveals
patient identity. The reports required by

§ 254c–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this subparagraph shall be conducted by the
Secretary acting through the Administrator
of the Health Resources and Services Administration and in collaboration with the Director of the Agency for Healthcare Research and Quality.
(b) Application for grant
The Secretary may make a grant under subsection (a) of this section only if an application
for the grant is submitted to the Secretary and
the application is in such form, is made in such
manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 330F, as added
Pub. L. 106–310, div. A, title XII, § 1201, Oct. 17,
2000, 114 Stat. 1132.)
§ 254c–7. Special needs adoption programs; public awareness campaign and other activities
(a) Special needs adoption awareness campaign
(1) In general
The Secretary shall, through making grants
to nonprofit private entities, provide for the
planning, development, and carrying out of a
national campaign to provide information to
the public regarding the adoption of children
with special needs.
(2) Input on planning and development
In providing for the planning and development of the national campaign under paragraph (1), the Secretary shall provide for input
from a number and variety of adoption organizations throughout the States in order that
the full national diversity of interests among
adoption organizations is represented in the
planning and development of the campaign.
(3) Certain features
With respect to the national campaign under
paragraph (1):
(A) The campaign shall be directed at various populations, taking into account as appropriate differences among geographic regions, and shall be carried out in the language and cultural context that is most appropriate to the population involved.
(B) The means through which the campaign may be carried out include—
(i) placing public service announcements
on television, radio, and billboards; and
(ii)
providing
information
through
means that the Secretary determines will
reach individuals who are most likely to
adopt children with special needs.
(C) The campaign shall provide information on the subsidies and supports that are
available to individuals regarding the adoption of children with special needs.
(D) The Secretary may provide that the
placement of public service announcements,
and the dissemination of brochures and

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other materials, is subject to review by the
Secretary.
(4) Matching requirement
(A) In general
With respect to the costs of the activities
to be carried out by an entity pursuant to
paragraph (1), a condition for the receipt of
a grant under such paragraph is that the entity agree to make available (directly or
through donations from public or private entities) non-Federal contributions toward
such costs in an amount that is not less than
25 percent of such costs.
(B) Determination of amount contributed
Non-Federal contributions under subparagraph (A) may be in cash or in kind, fairly
evaluated, including plant, equipment, or
services. Amounts provided by the Federal
Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions.
(b) National resources program
The Secretary shall (directly or through grant
or contract) carry out a program that, through
toll-free telecommunications, makes available
to the public information regarding the adoption of children with special needs. Such information shall include the following:
(1) A list of national, State, and regional organizations that provide services regarding
such adoptions, including exchanges and other
information on communicating with the organizations. The list shall represent the full national diversity of adoption organizations.
(2) Information beneficial to individuals who
adopt such children, including lists of support
groups for adoptive parents and other
postadoptive services.
(c) Other programs
With respect to the adoption of children with
special needs, the Secretary shall make grants—
(1) to provide assistance to support groups
for adoptive parents, adopted children, and
siblings of adopted children; and
(2) to carry out studies to identify—
(A) the barriers to completion of the adoption process; and
(B) those components that lead to favorable long-term outcomes for families that
adopt children with special needs.
(d) Application for grant
The Secretary may make an award of a grant
or contract under this section only if an application for the award is submitted to the Secretary
and the application is in such form, is made in
such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(e) Funding
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 330G, as added
Pub. L. 106–310, div. A, title XII, § 1211, Oct. 17,
2000, 114 Stat. 1135.)

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§ 254c–8. Healthy start for infants
(a) In general
(1) Continuation and expansion of program
The Secretary, acting through the Administrator of the Health Resources and Services
Administration, Maternal and Child Health
Bureau, shall under authority of this section
continue in effect the Healthy Start Initiative
and may, during fiscal year 2001 and subsequent years, carry out such program on a national basis.
(2) Definition
For purposes of paragraph (1), the term
‘‘Healthy Start Initiative’’ is a reference to
the program that, as an initiative to reduce
the rate of infant mortality and improve perinatal outcomes, makes grants for project
areas with high annual rates of infant mortality and that, prior to the effective date of this
section, was a demonstration program carried
out under section 241 of this title.
(b) Considerations in making grants
(1) Requirements
In making grants under subsection (a), the
Secretary shall require that applicants (in addition to meeting all eligibility criteria established by the Secretary) establish, for project
areas under such subsection, community-based
consortia of individuals and organizations (including agencies responsible for administering
block grant programs under title V of the Social Security Act [42 U.S.C. 701 et seq.], consumers of project services, public health departments, hospitals, health centers under
section 254b of this title, and other significant
sources of health care services) that are appropriate for participation in projects under subsection (a) of this section.
(2) Other considerations
In making grants under subsection (a), the
Secretary shall take into consideration the
following:
(A) Factors that contribute to infant mortality, such as low birthweight.
(B) The extent to which applicants for
such grants facilitate—
(i) a community-based approach to the
delivery of services; and
(ii) a comprehensive approach to women’s health care to improve perinatal outcomes.
(3) Special projects
Nothing in paragraph (2) shall be construed
to prevent the Secretary from awarding grants
under subsection (a) for special projects that
are intended to address significant disparities
in perinatal health indicators in communities
along the United States-Mexico border or in
Alaska or Hawaii.
(c) Coordination
Recipients of grants under subsection (a) of
this section shall coordinate their services and
activities with the State agency or agencies
that administer block grant programs under
title V of the Social Security Act [42 U.S.C. 701
et seq.] in order to promote cooperation, inte-

§ 254c–8

gration, and dissemination of information with
Statewide systems and with other community
services funded under the Maternal and Child
Health Block Grant.
(d) Rule of construction
Except to the extent inconsistent with this
section, this section may not be construed as affecting the authority of the Secretary to make
modifications in the program carried out under
subsection (a) of this section.
(e) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated—
(A) $120,000,000 for fiscal year 2008; and
(B) for each of fiscal years 2009 through
2013, the amount authorized for the preceding fiscal year increased by the percentage
increase in the Consumer Price Index for all
urban consumers for such year.
(2) Allocation
(A) Program administration
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may
reserve up to 5 percent for coordination, dissemination, technical assistance, and data
activities that are determined by the Secretary to be appropriate for carrying out the
program under this section.
(B) Evaluation
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may
reserve up to 1 percent for evaluations of
projects carried out under subsection (a).
Each such evaluation shall include a determination of whether such projects have been
effective in reducing the disparity in health
status between the general population and
individuals who are members of racial or
ethnic minority groups.
(July 1, 1944, ch. 373, title III, § 330H, as added
Pub. L. 106–310, div. A, title XV, § 1501, Oct. 17,
2000, 114 Stat. 1146; amended Pub. L. 108–271,
§ 8(b), July 7, 2004, 118 Stat. 814; Pub. L. 110–339,
§ 2, Oct. 3, 2008, 122 Stat. 3733.)
REFERENCES IN TEXT
The effective date of this section, referred to in subsec. (a)(2), is the date of enactment of Pub. L. 106–310,
which was approved Oct. 17, 2000.
The Social Security Act, referred to in subsecs. (b)(1)
and (c), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title
V of the Act is classified generally to subchapter V
(§ 701 et seq.) of chapter 7 of this title. For complete
classification of this Act to the Code, see section 1305
of this title and Tables.
AMENDMENTS
2008—Subsec. (a)(3). Pub. L. 110–339, § 2(b)(1), struck
out par. (3). Text read as follows: ‘‘Effective upon increased funding beyond fiscal year 1999 for such Initiative, additional grants may be made to States to assist
communities with technical assistance, replication of
successful projects, and State policy formation to reduce infant and maternal mortality and morbidity.’’
Subsec. (b). Pub. L. 110–339, § 2(a), substituted ‘‘Considerations in making grants’’ for ‘‘Requirements for
making grants’’ in heading, designated existing provisions as par. (1), inserted par. heading, and added pars.
(2) and (3).

§ 254c–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (e). Pub. L. 110–339, § 2(b)(2), (c), added subsec.
(e) and struck out former subsec. (e) which related to
additional services for at-risk pregnant women and infants.
Subsec. (f). Pub. L. 110–339, § 2(b)(2), struck out subsec. (f) which related to funding of program and additional services for at-risk pregnant women and infants.
2004—Subsec. (e)(3). Pub. L. 108–271 substituted ‘‘Government Accountability Office’’ for ‘‘General Accounting Office’’ in heading.

§ 254c–9. Establishment of program of grants
(a) In general
The Secretary of Health and Human Services
shall in accordance with sections 254c–9 to
254c–13 of this title make grants to provide for
projects for the establishment, operation, and
coordination of effective and cost-efficient systems for the delivery of essential services to individuals with lupus and their families.
(b) Recipients of grants
A grant under subsection (a) of this section
may be made to an entity only if the entity is
a public or nonprofit private entity, which may
include a State or local government; a public or
nonprofit private hospital, community-based organization, hospice, ambulatory care facility,
community health center, migrant health center, or homeless health center; or other appropriate public or nonprofit private entity.
(c) Certain activities
To the extent practicable and appropriate, the
Secretary shall ensure that projects under subsection (a) of this section provide services for
the diagnosis and disease management of lupus.
Activities that the Secretary may authorize for
such projects may also include the following:
(1) Delivering or enhancing outpatient, ambulatory, and home-based health and support
services, including case management and comprehensive treatment services, for individuals
with lupus; and delivering or enhancing support services for their families.
(2) Delivering or enhancing inpatient care
management services that prevent unnecessary hospitalization or that expedite discharge, as medically appropriate, from inpatient facilities of individuals with lupus.
(3) Improving the quality, availability, and
organization of health care and support services (including transportation services, attendant care, homemaker services, day or respite care, and providing counseling on financial assistance and insurance) for individuals
with lupus and support services for their families.
(d) Integration with other programs
To the extent practicable and appropriate, the
Secretary shall integrate the program under
sections 254c–9 to 254c–13 of this title with other
grant programs carried out by the Secretary, including the program under section 254b of this
title.
(Pub. L. 106–505, title V, § 521, Nov. 13, 2000, 114
Stat. 2343.)
CODIFICATION
Section was enacted as part of the Lupus Research
and Care Amendments of 2000, and also as part of the

Page 282

Public Health Improvement Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 254c–10. Certain requirements
A grant may be made under section 254c–9 of
this title only if the applicant involved makes
the following agreements:
(1) Not more than 5 percent of the grant will
be used for administration, accounting, reporting, and program oversight functions.
(2) The grant will be used to supplement and
not supplant funds from other sources related
to the treatment of lupus.
(3) The applicant will abide by any limitations deemed appropriate by the Secretary on
any charges to individuals receiving services
pursuant to the grant. As deemed appropriate
by the Secretary, such limitations on charges
may vary based on the financial circumstances of the individual receiving services.
(4) The grant will not be expended to make
payment for services authorized under section
254c–9(a) of this title to the extent that payment has been made, or can reasonably be expected to be made, with respect to such services—
(A) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(5) The applicant will, at each site at which
the applicant provides services under section
254c–9(a) of this title, post a conspicuous notice informing individuals who receive the
services of any Federal policies that apply to
the applicant with respect to the imposition of
charges on such individuals.
(Pub. L. 106–505, title V, § 522, Nov. 13, 2000, 114
Stat. 2344.)
CODIFICATION
Section was enacted as part of the Lupus Research
and Care Amendments of 2000, and also as part of the
Public Health Improvement Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 254c–11. Technical assistance
The Secretary may provide technical assistance to assist entities in complying with the requirements of sections 254c–9 to 254c–13 of this
title in order to make such entities eligible to
receive grants under section 254c–9 of this title.
(Pub. L. 106–505, title V, § 523, Nov. 13, 2000, 114
Stat. 2344.)
CODIFICATION
Section was enacted as part of the Lupus Research
and Care Amendments of 2000, and also as part of the
Public Health Improvement Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 254c–12. Definitions
For purposes of sections 254c–9 to 254c–13 of
this title:
(1) Official poverty line
The term ‘‘official poverty line’’ means the
poverty line established by the Director of the

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Office of Management and Budget and revised
by the Secretary in accordance with section
9902(2) of this title.
(2) Secretary
The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(Pub. L. 106–505, title V, § 524, Nov. 13, 2000, 114
Stat. 2344.)
CODIFICATION
Section was enacted as part of the Lupus Research
and Care Amendments of 2000, and also as part of the
Public Health Improvement Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 254c–13. Authorization of appropriations
For the purpose of carrying out sections 254c–9
to 254c–13 of this title, there are authorized to be
appropriated such sums as may be necessary for
each of the fiscal years 2001 through 2003.
(Pub. L. 106–505, title V, § 525, Nov. 13, 2000, 114
Stat. 2345.)
CODIFICATION
Section was enacted as part of the Lupus Research
and Care Amendments of 2000, and also as part of the
Public Health Improvement Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 254c–14. Telehealth network and telehealth resource centers grant programs
(a) Definitions
In this section:
(1) Director; Office
The terms ‘‘Director’’ and ‘‘Office’’ mean the
Director and Office specified in subsection (c)
of this section.
(2) Federally qualified health center and rural
health clinic
The term ‘‘Federally qualified health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in section 1395x(aa) of
this title.
(3) Frontier community
The term ‘‘frontier community’’ shall have
the meaning given the term in regulations issued under subsection (r) of this section.
(4) Medically underserved area
The term ‘‘medically underserved area’’ has
the meaning given the term ‘‘medically underserved community’’ in section 295p(6) of this
title.
(5) Medically underserved population
The term ‘‘medically underserved population’’ has the meaning given the term in section 254b(b)(3) of this title.
(6) Telehealth services
The term ‘‘telehealth services’’ means services provided through telehealth technologies.
(7) Telehealth technologies
The term ‘‘telehealth technologies’’ means
technologies relating to the use of electronic
information, and telecommunications tech-

§ 254c–14

nologies, to support and promote, at a distance, health care, patient and professional
health-related education, health administration, and public health.
(b) Programs
The Secretary shall establish, under section
241 of this title, telehealth network and telehealth resource centers grant programs.
(c) Administration
(1) Establishment
There is established in the Health Resources
and Services Administration an Office for the
Advancement of Telehealth. The Office shall
be headed by a Director.
(2) Duties
The telehealth network and telehealth resource centers grant programs established
under section 241 of this title shall be administered by the Director, in consultation with the
State offices of rural health, State offices concerning primary care, or other appropriate
State government entities.
(d) Grants
(1) Telehealth network grants
The Director may, in carrying out the telehealth network grant program referred to in
subsection (b) of this section, award grants to
eligible entities for projects to demonstrate
how telehealth technologies can be used
through telehealth networks in rural areas,
frontier communities, and medically underserved areas, and for medically underserved
populations, to—
(A) expand access to, coordinate, and improve the quality of health care services;
(B) improve and expand the training of
health care providers; and
(C) expand and improve the quality of
health information available to health care
providers, and patients and their families,
for decisionmaking.
(2) Telehealth resource centers grants
The Director may, in carrying out the telehealth resource centers grant program referred to in subsection (b) of this section,
award grants to eligible entities for projects
to demonstrate how telehealth technologies
can be used in the areas and communities, and
for the populations, described in paragraph (1),
to establish telehealth resource centers.
(e) Grant periods
The Director may award grants under this section for periods of not more than 4 years.
(f) Eligible entities
(1) Telehealth network grants
(A) Grant recipient
To be eligible to receive a grant under subsection (d)(1) of this section, an entity shall
be a nonprofit entity.
(B) Telehealth networks
(i) In general
To be eligible to receive a grant under
subsection (d)(1) of this section, an entity
shall demonstrate that the entity will pro-

§ 254c–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

vide services through a telehealth network.
(ii) Nature of entities
Each entity participating in the telehealth network may be a nonprofit or forprofit entity.
(iii) Composition of network
The telehealth network shall include at
least 2 of the following entities (at least 1
of which shall be a community-based
health care provider):
(I) Community or migrant health centers or other Federally qualified health
centers.
(II) Health care providers, including
pharmacists, in private practice.
(III) Entities operating clinics, including rural health clinics.
(IV) Local health departments.
(V) Nonprofit hospitals, including community access hospitals.
(VI) Other publicly funded health or
social service agencies.
(VII) Long-term care providers.
(VIII) Providers of health care services
in the home.
(IX) Providers of outpatient mental
health services and entities operating
outpatient mental health facilities.
(X) Local or regional emergency health
care providers.
(XI) Institutions of higher education.
(XII) Entities operating dental clinics.
(2) Telehealth resource centers grants
To be eligible to receive a grant under subsection (d)(2) of this section, an entity shall be
a nonprofit entity.
(g) Applications
To be eligible to receive a grant under subsection (d) of this section, an eligible entity, in
consultation with the appropriate State office of
rural health or another appropriate State entity, shall prepare and submit to the Secretary
an application, at such time, in such manner,
and containing such information as the Secretary may require, including—
(1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
(2) a description of the manner in which the
project funded under the grant will meet the
health care needs of rural or other populations
to be served through the project, or improve
the access to services of, and the quality of
the services received by, those populations;
(3) evidence of local support for the project,
and a description of how the areas, communities, or populations to be served will be involved in the development and ongoing operations of the project;
(4) a plan for sustaining the project after
Federal support for the project has ended;
(5) information on the source and amount of
non-Federal funds that the entity will provide
for the project;
(6) information demonstrating the long-term
viability of the project, and other evidence of
institutional commitment of the entity to the
project;

Page 284

(7) in the case of an application for a project
involving a telehealth network, information
demonstrating how the project will promote
the integration of telehealth technologies into
the operations of health care providers, to
avoid redundancy, and improve access to and
the quality of care; and
(8) other such information as the Secretary
determines to be appropriate.
(h) Terms; conditions; maximum amount of assistance
The Secretary shall establish the terms and
conditions of each grant program described in
subsection (b) of this section and the maximum
amount of a grant to be awarded to an individual recipient for each fiscal year under this section. The Secretary shall publish, in a publication of the Health Resources and Services Administration, notice of the application requirements for each grant program described in subsection (b) of this section for each fiscal year.
(i) Preferences
(1) Telehealth networks
In awarding grants under subsection (d)(1) of
this section for projects involving telehealth
networks, the Secretary shall give preference
to an eligible entity that meets at least 1 of
the following requirements:
(A) Organization
The eligible entity is a rural communitybased organization or another communitybased organization.
(B) Services
The eligible entity proposes to use Federal
funds made available through such a grant
to develop plans for, or to establish, telehealth networks that provide mental health,
public health, long-term care, home care,
preventive, or case management services.
(C) Coordination
The eligible entity demonstrates how the
project to be carried out under the grant will
be coordinated with other relevant federally
funded projects in the areas, communities,
and populations to be served through the
grant.
(D) Network
The eligible entity demonstrates that the
project involves a telehealth network that
includes an entity that—
(i) provides clinical health care services,
or educational services for health care providers and for patients or their families;
and
(ii) is—
(I) a public library;
(II) an institution of higher education;
or
(III) a local government entity.
(E) Connectivity
The eligible entity proposes a project that
promotes local connectivity within areas,
communities, or populations to be served
through the project.
(F) Integration
The eligible entity demonstrates that
health care information has been integrated
into the project.

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(2) Telehealth resource centers
In awarding grants under subsection (d)(2) of
this section for projects involving telehealth
resource centers, the Secretary shall give preference to an eligible entity that meets at least
1 of the following requirements:
(A) Provision of services
The eligible entity has a record of success
in the provision of telehealth services to
medically underserved areas or medically
underserved populations.
(B) Collaboration and sharing of expertise
The eligible entity has a demonstrated
record of collaborating and sharing expertise
with providers of telehealth services at the
national, regional, State, and local levels.
(C) Broad range of telehealth services
The eligible entity has a record of providing a broad range of telehealth services,
which may include—
(i) a variety of clinical specialty services;
(ii) patient or family education;
(iii) health care professional education;
and
(iv) rural residency support programs.
(j) Distribution of funds
(1) In general
In awarding grants under this section, the
Director shall ensure, to the greatest extent
possible, that such grants are equitably distributed among the geographical regions of
the United States.
(2) Telehealth networks
In awarding grants under subsection (d)(1) of
this section for a fiscal year, the Director
shall ensure that—
(A) not less than 50 percent of the funds
awarded shall be awarded for projects in
rural areas; and
(B) the total amount of funds awarded for
such projects for that fiscal year shall be not
less than the total amount of funds awarded
for such projects for fiscal year 2001 under
section 254c of this title (as in effect on the
day before October 26, 2002).
(k) Use of funds
(1) Telehealth network program
The recipient of a grant under subsection
(d)(1) of this section may use funds received
through such grant for salaries, equipment,
and operating or other costs, including the
cost of—
(A) developing and delivering clinical telehealth services that enhance access to community-based health care services in rural
areas, frontier communities, or medically
underserved areas, or for medically underserved populations;
(B) developing and acquiring, through
lease or purchase, computer hardware and
software, audio and video equipment, computer network equipment, interactive equipment, data terminal equipment, and other
equipment that furthers the objectives of
the telehealth network grant program;

§ 254c–14

(C)(i) developing and providing distance
education, in a manner that enhances access
to care in rural areas, frontier communities,
or medically underserved areas, or for medically underserved populations; or
(ii) mentoring, precepting, or supervising
health care providers and students seeking
to become health care providers, in a manner that enhances access to care in the areas
and communities, or for the populations, described in clause (i);
(D) developing and acquiring instructional
programming;
(E)(i) providing for transmission of medical data, and maintenance of equipment; and
(ii) providing for compensation (including
travel expenses) of specialists, and referring
health care providers, who are providing
telehealth services through the telehealth
network, if no third party payment is available for the telehealth services delivered
through the telehealth network;
(F) developing projects to use telehealth
technology to facilitate collaboration between health care providers;
(G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the telehealth services; and
(H) carrying out such other activities as
are consistent with achieving the objectives
of this section, as determined by the Secretary.
(2) Telehealth resource centers
The recipient of a grant under subsection
(d)(2) of this section may use funds received
through such grant for salaries, equipment,
and operating or other costs for—
(A) providing technical assistance, training, and support, and providing for travel expenses, for health care providers and a range
of health care entities that provide or will
provide telehealth services;
(B) disseminating information and research findings related to telehealth services;
(C) promoting effective collaboration
among telehealth resource centers and the
Office;
(D) conducting evaluations to determine
the best utilization of telehealth technologies to meet health care needs;
(E) promoting the integration of the technologies used in clinical information systems with other telehealth technologies;
(F) fostering the use of telehealth technologies to provide health care information
and education for health care providers and
consumers in a more effective manner; and
(G) implementing special projects or studies under the direction of the Office.
(l) Prohibited uses of funds
An entity that receives a grant under this section may not use funds made available through
the grant—
(1) to acquire real property;
(2) for expenditures to purchase or lease
equipment, to the extent that the expenditures would exceed 40 percent of the total
grant funds;
(3) in the case of a project involving a telehealth network, to purchase or install trans-

§ 254c–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mission equipment (such as laying cable or
telephone lines, or purchasing or installing
microwave towers, satellite dishes, amplifiers,
or digital switching equipment);
(4) to pay for any equipment or transmission
costs not directly related to the purposes for
which the grant is awarded;
(5) to purchase or install general purpose
voice telephone systems;
(6) for construction; or
(7) for expenditures for indirect costs (as determined by the Secretary), to the extent that
the expenditures would exceed 15 percent of
the total grant funds.
(m) Collaboration
In providing services under this section, an eligible entity shall collaborate, if feasible, with
entities that—
(1)(A) are private or public organizations,
that receive Federal or State assistance; or
(B) are public or private entities that operate centers, or carry out programs, that receive Federal or State assistance; and
(2) provide telehealth services or related activities.
(n) Coordination with other agencies
The Secretary shall coordinate activities carried out under grant programs described in subsection (b) of this section, to the extent practicable, with Federal and State agencies and
nonprofit organizations that are operating similar programs, to maximize the effect of public
dollars in funding meritorious proposals.
(o) Outreach activities
The Secretary shall establish and implement
procedures to carry out outreach activities to
advise potential end users of telehealth services
in rural areas, frontier communities, medically
underserved areas, and medically underserved
populations in each State about the grant programs described in subsection (b) of this section.
(p) Telehealth
It is the sense of Congress that, for purposes of
this section, States should develop reciprocity
agreements so that a provider of services under
this section who is a licensed or otherwise authorized health care provider under the law of 1
or more States, and who, through telehealth
technology, consults with a licensed or otherwise authorized health care provider in another
State, is exempt, with respect to such consultation, from any State law of the other State that
prohibits such consultation on the basis that the
first health care provider is not a licensed or authorized health care provider under the law of
that State.
(q) Report
Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate committees of Congress a report on the
progress and accomplishments of the grant programs described in subsection (b) of this section.
(r) Regulations
The Secretary shall issue regulations specifying, for purposes of this section, a definition of
the term ‘‘frontier area’’. The definition shall be
based on factors that include population den-

Page 286

sity, travel distance in miles to the nearest
medical facility, travel time in minutes to the
nearest medical facility, and such other factors
as the Secretary determines to be appropriate.
The Secretary shall develop the definition in
consultation with the Director of the Bureau of
the Census and the Administrator of the Economic Research Service of the Department of
Agriculture.
(s) Authorization of appropriations
There are authorized to be appropriated to
carry out this section—
(1) for grants under subsection (d)(1) of this
section, $40,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years 2003 through 2006; and
(2) for grants under subsection (d)(2) of this
section, $20,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years 2003 through 2006.
(July 1, 1944, ch. 373, title III, § 330I, as added
Pub. L. 107–251, title II, § 212, Oct. 26, 2002, 116
Stat. 1632; amended Pub. L. 108–163, § 2(c), Dec. 6,
2003, 117 Stat. 2021.)
AMENDMENTS
2003—Subsec. (a)(4). Pub. L. 108–163, § 2(c)(1), substituted ‘‘section 295p(6)’’ for ‘‘section 295p’’.
Subsec. (c)(1). Pub. L. 108–163, § 2(c)(2), substituted
‘‘Health Resources and Services Administration’’ for
‘‘Health and Resources and Services Administration’’.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendments by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 254c–15. Rural emergency medical service
training and equipment assistance program
(a) Grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the
‘‘Secretary’’) shall award grants to eligible entities to enable such entities to provide for improved emergency medical services in rural
areas.
(b) Eligibility
To be eligible to receive a grant under this
section, an entity shall—
(1) be—
(A) a State emergency medical services office;
(B) a State emergency medical services association;
(C) a State office of rural health;
(D) a local government entity;
(E) a State or local ambulance provider; or
(F) any other entity determined appropriate by the Secretary; and
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary
may require, that includes—
(A) a description of the activities to be
carried out under the grant; and
(B) an assurance that the eligible entity
will comply with the matching requirement
of subsection (e) of this section.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Use of funds
An entity shall use amounts received under a
grant made under subsection (a) of this section,
either directly or through grants to emergency
medical service squads that are located in, or
that serve residents of, a nonmetropolitan statistical area, an area designated as a rural area
by any law or regulation of a State, or a rural
census tract of a metropolitan statistical area
(as determined under the most recent Goldsmith
Modification, originally published in a notice of
availability of funds in the Federal Register on
February 27, 1992, 57 Fed. Reg. 6725), to—
(1) recruit emergency medical service personnel;
(2) recruit volunteer emergency medical
service personnel;
(3) train emergency medical service personnel in emergency response, injury prevention,
safety awareness, and other topics relevant to
the delivery of emergency medical services;
(4) fund specific training to meet Federal or
State certification requirements;
(5) develop new ways to educate emergency
health care providers through the use of technology-enhanced educational methods (such as
distance learning);
(6) acquire emergency medical services
equipment, including cardiac defibrillators;
(7) acquire personal protective equipment for
emergency medical services personnel as required by the Occupational Safety and Health
Administration; and
(8) educate the public concerning cardiopulmonary resuscitation, first aid, injury prevention, safety awareness, illness prevention,
and other related emergency preparedness topics.
(d) Preference
In awarding grants under this section the Secretary shall give preference to—
(1) applications that reflect a collaborative
effort by 2 or more of the entities described in
subparagraphs (A) through (F) of subsection
(b)(1) of this section; and
(2) applications submitted by entities that
intend to use amounts provided under the
grant to fund activities described in any of
paragraphs (1) through (5) of subsection (c) of
this section.
(e) Matching requirement
The Secretary may not award a grant under
this section to an entity unless the entity agrees
that the entity will make available (directly or
through contributions from other public or private entities) non-Federal contributions toward
the activities to be carried out under the grant
in an amount equal to 25 percent of the amount
received under the grant.
(f) Emergency medical services
In this section, the term ‘‘emergency medical
services’’—
(1) means resources used by a qualified public or private nonprofit entity, or by any other
entity recognized as qualified by the State involved, to deliver medical care outside of a
medical facility under emergency conditions
that occur—
(A) as a result of the condition of the patient; or

§ 254c–16

(B) as a result of a natural disaster or
similar situation; and
(2) includes services delivered by an emergency medical services provider (either compensated or volunteer) or other provider recognized by the State involved that is licensed or
certified by the State as an emergency medical technician or its equivalent (as determined
by the State), a registered nurse, a physician
assistant, or a physician that provides services
similar to services provided by such an emergency medical services provider.
(g) Authorization of appropriations
(1) In general
There are authorized to be appropriated to
carry out this section such sums as may be
necessary for each of fiscal years 2002 through
2006.
(2) Administrative costs
The Secretary may use not more than 10 percent of the amount appropriated under paragraph (1) for a fiscal year for the administrative expenses of carrying out this section.
(July 1, 1944, ch. 373, title III, § 330J, as added
Pub. L. 107–251, title II, § 221, Oct. 26, 2002, 116
Stat. 1638.)
§ 254c–16. Mental health services delivered via
telehealth
(a) Definitions
In this section:
(1) Eligible entity
The term ‘‘eligible entity’’ means a public or
nonprofit private telehealth provider network
that offers services that include mental health
services provided by qualified mental health
providers.
(2) Qualified mental health professionals
The term ‘‘qualified mental health professionals’’ refers to providers of mental health
services reimbursed under the medicare program carried out under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) who
have additional training in the treatment of
mental illness in children and adolescents or
who have additional training in the treatment
of mental illness in the elderly.
(3) Special populations
The term ‘‘special populations’’ refers to the
following 2 distinct groups:
(A) Children and adolescents in mental
health underserved rural areas or in mental
health underserved urban areas.
(B) Elderly individuals located in longterm care facilities in mental health underserved rural or urban areas.
(4) Telehealth
The term ‘‘telehealth’’ means the use of
electronic information and telecommunications technologies to support long distance
clinical health care, patient and professional
health-related education, public health, and
health administration.
(b) Program authorized
(1) In general
The Secretary, acting through the Director
of the Office for the Advancement of Tele-

§ 254c–17

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health of the Health Resources and Services
Administration, shall award grants to eligible
entities to establish demonstration projects
for the provision of mental health services to
special populations as delivered remotely by
qualified mental health professionals using
telehealth and for the provision of education
regarding mental illness as delivered remotely
by qualified mental health professionals using
telehealth.
(2) Populations served
The Secretary shall award the grants under
paragraph (1) in a manner that distributes the
grants so as to serve equitably the populations
described in subparagraphs (A) and (B) of subsection (a)(3) of this section.
(c) Use of funds
(1) In general
An eligible entity that receives a grant
under this section shall use the grant funds—
(A) for the populations described in subsection (a)(3)(A) of this section—
(i) to provide mental health services, including diagnosis and treatment of mental
illness, as delivered remotely by qualified
mental health professionals using telehealth; and
(ii) to collaborate with local public
health entities to provide the mental
health services; and
(B) for the populations described in subsection (a)(3)(B) of this section—
(i) to provide mental health services, including diagnosis and treatment of mental
illness, in long-term care facilities as delivered remotely by qualified mental
health professionals using telehealth; and
(ii) to collaborate with local public
health entities to provide the mental
health services.
(2) Other uses
An eligible entity that receives a grant
under this section may also use the grant
funds to—
(A) pay telecommunications costs; and
(B) pay qualified mental health professionals on a reasonable cost basis as determined by the Secretary for services rendered.
(3) Prohibited uses
An eligible entity that receives a grant
under this section shall not use the grant
funds to—
(A) purchase or install transmission equipment (other than such equipment used by
qualified mental health professionals to deliver mental health services using telehealth
under the project involved); or
(B) build upon or acquire real property.
(d) Equitable distribution
In awarding grants under this section, the Secretary shall ensure, to the greatest extent possible, that such grants are equitably distributed
among geographical regions of the United
States.
(e) Application
An entity that desires a grant under this section shall submit an application to the Sec-

Page 288

retary at such time, in such manner, and containing such information as the Secretary determines to be reasonable.
(f) Report
Not later than 4 years after October 26, 2002,
the Secretary shall prepare and submit to the
appropriate committees of Congress a report
that shall evaluate activities funded with grants
under this section.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $20,000,000 for fiscal year
2002 and such sums as may be necessary for fiscal years 2003 through 2006.
(July 1, 1944, ch. 373, title III, § 330K, as added
Pub. L. 107–251, title II, § 221, Oct. 26, 2002, 116
Stat. 1640; amended Pub. L. 108–163, § 2(d), Dec. 6,
2003, 117 Stat. 2021.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (a)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Title XVIII of the Act is classified generally to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
AMENDMENTS
2003—Subsec. (b)(2). Pub. L. 108–163, § 2(d)(1), substituted ‘‘subsection (a)(3)’’ for ‘‘subsection (a)(4)’’.
Subsec. (c)(1)(A). Pub. L. 108–163, § 2(d)(2)(A), substituted
‘‘subsection
(a)(3)(A)’’
for
‘‘subsection
(a)(4)(A)’’.
Subsec. (c)(1)(B). Pub. L. 108–163, § 2(d)(2)(B), substituted
‘‘subsection
(a)(3)(B)’’
for
‘‘subsection
(a)(4)(B)’’.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendments by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 254c–17. Repealed. Pub. L. 108–163, § 2(e)(2),
Dec. 6, 2003, 117 Stat. 2021
Section, Pub. L. 107–251, title I, § 102, Oct. 26, 2002, 116
Stat. 1627, provided for grants to State professional licensing boards to develop and implement State policies
to promote telemedicine.
EFFECTIVE DATE OF REPEAL
Repeal deemed to have taken effect immediately
after the enactment of Pub. L. 107–251, see section 3 of
Pub. L. 108–163, set out as an Effective Date of 2003
Amendments note under section 233 of this title.

§ 254c–18. Telemedicine; incentive grants regarding coordination among States
(a) In general
The Secretary may make grants to State professional licensing boards to carry out programs
under which such licensing boards of various
States cooperate to develop and implement
State policies that will reduce statutory and
regulatory barriers to telemedicine.
(b) Authorization of appropriations
For the purpose of carrying out subsection (a)
of this section, there are authorized to be appropriated such sums as may be necessary for each
of the fiscal years 2002 through 2006.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title III, § 330L, as added
Pub. L. 108–163, § 2(e)(1), Dec. 6, 2003, 117 Stat.
2021.)
EFFECTIVE DATE
Section deemed to have taken effect immediately
after the enactment of Pub. L. 107–251, see section 3 of
Pub. L. 108–163, set out as an Effective Date of 2003
Amendments note under section 233 of this title.
SUBPART II—NATIONAL HEALTH SERVICE CORPS
PROGRAM

AMENDMENTS
1976—Pub. L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976,
90 Stat. 2268, added heading ‘‘Subpart II—National
Health Service Corps Program’’.

§ 254d. National Health Service Corps
(a) Establishment; composition; purpose; definitions
(1) For the purpose of eliminating health manpower shortages in health professional shortage
areas, there is established, within the Service,
the National Health Service Corps, which shall
consist of—
(A) such officers of the Regular and Reserve
Corps of the Service as the Secretary may designate,
(B) such civilian employees of the United
States as the Secretary may appoint, and
(C) such other individuals who are not employees of the United States.
(2) The Corps shall be utilized by the Secretary to provide primary health services in
health professional shortage areas.
(3) For purposes of this subpart and subpart
III:
(A) The term ‘‘Corps’’ means the National
Health Service Corps.
(B) The term ‘‘Corps member’’ means each of
the officers, employees, and individuals of
which the Corps consists pursuant to paragraph (1).
(C) The term ‘‘health professional shortage
area’’ has the meaning given such term in section 254e(a) of this title.
(D) The term ‘‘primary health services’’
means health services regarding family medicine, internal medicine, pediatrics, obstetrics
and gynecology, dentistry, or mental health,
that are provided by physicians or other
health professionals.
(E)(i) The term ‘‘behavioral and mental
health professionals’’ means health service
psychologists, licensed clinical social workers,
licensed professional counselors, marriage and
family therapists, psychiatric nurse specialists, and psychiatrists.
(ii) The term ‘‘graduate program of behavioral and mental health’’ means a program
that trains behavioral and mental health professionals.
(b) Recruitment and fellowship programs
(1) The Secretary may conduct at schools of
medicine, osteopathic medicine, dentistry, and,
as appropriate, nursing and other schools of the
health professions, including schools at which
graduate programs of behavioral and mental
health are offered, and at entities which train

§ 254d

allied health personnel, recruiting programs for
the Corps, the Scholarship Program, and the
Loan Repayment Program. Such recruiting programs shall include efforts to recruit individuals
who will serve in the Corps other than pursuant
to obligated service under the Scholarship or
Loan Repayment Program.
(2) In the case of physicians, dentists, behavioral and mental health professionals, certified
nurse midwives, certified nurse practitioners,
and physician assistants who have an interest
and a commitment to providing primary health
care, the Secretary may establish fellowship
programs to enable such health professionals to
gain exposure to and expertise in the delivery of
primary health services in health professional
shortage areas. To the maximum extent practicable, the Secretary shall ensure that any such
programs are established in conjunction with
accredited residency programs, and other training programs, regarding such health professions.
(c) Travel and moving expenses; persons entitled; reimbursement; limitation
(1) The Secretary may reimburse an applicant
for a position in the Corps (including an individual considering entering into a written agreement pursuant to section 254n of this title) for
the actual and reasonable expenses incurred in
traveling to and from the applicant’s place of
residence to an eligible site to which the applicant may be assigned under section 254f of this
title for the purpose of evaluating such site with
regard to being assigned at such site. The Secretary may establish a maximum total amount
that may be paid to an individual as reimbursement for such expenses.
(2) The Secretary may also reimburse the applicant for the actual and reasonable expenses
incurred for the travel of 1 family member to accompany the applicant to such site. The Secretary may establish a maximum total amount
that may be paid to an individual as reimbursement for such expenses.
(3) In the case of an individual who has entered into a contract for obligated service under
the Scholarship Program or under the Loan Repayment Program, the Secretary may reimburse
such individual for all or part of the actual and
reasonable expenses incurred in transporting the
individual, the individual’s family, and the family’s possessions to the site of the individual’s
assignment under section 254f of this title. The
Secretary may establish a maximum total
amount that may be paid to an individual as reimbursement for such expenses.
(d) Monthly pay adjustments of members directly
engaged in delivery of health services in
health professional shortage area; ‘‘monthly
pay’’ defined; monthly pay adjustment of
member with service obligation incurred
under Scholarship Program or Loan Repayment Program; personnel system applicable
(1) The Secretary may, under regulations promulgated by the Secretary, adjust the monthly
pay of each member of the Corps (other than a
member described in subsection (a)(1)(C) of this
section) who is directly engaged in the delivery
of health services in a health professional shortage area as follows:
(A) During the first 36 months in which such
a member is so engaged in the delivery of

§ 254d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health services, his monthly pay may be increased by an amount which when added to
the member’s monthly pay and allowances
will provide a monthly income competitive
with the average monthly income from a practice of an individual who is a member of the
profession of the Corps member, who has
equivalent training, and who has been in practice for a period equivalent to the period during which the Corps member has been in practice.
(B) During the period beginning upon the expiration of the 36 months referred to in subparagraph (A) and ending with the month in
which the member’s monthly pay and allowances are equal to or exceed the monthly income he received for the last of such 36
months, the member may receive in addition
to his monthly pay and allowances an amount
which when added to such monthly pay and allowances equals the monthly income he received for such last month.
(C) For each month in which a member is directly engaged in the delivery of health services in a health professional shortage area in
accordance with an agreement with the Secretary entered into under section 294n(f)(1)(C) 1
of this title, under which the Secretary is obligated to make payments in accordance with
section 294n(f)(2) 1 of this title, the amount of
any monthly increase under subparagraph (A)
or (B) with respect to such member shall be
decreased by an amount equal to one-twelfth
of the amount which the Secretary is obligated to pay upon the completion of the year
of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the
term ‘‘monthly pay’’ includes special pay received under chapter 5 of title 37.
(2) In the case of a member of the Corps who
is directly engaged in the delivery of health
services in a health professional shortage area
in accordance with a service obligation incurred
under the Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may be made for such
a member only upon satisfactory completion of
such service obligation, and the first 36 months
of such member’s being so engaged in the delivery of health services shall, for purposes of paragraph (1)(A), be deemed to begin upon such satisfactory completion.
(3) A member of the Corps described in subparagraph (C) of subsection (a)(1) of this section
shall when assigned to an entity under section
254f of this title be subject to the personnel system of such entity, except that such member
shall receive during the period of assignment
the income that the member would receive if the
member was a member of the Corps described in
subparagraph (B) of such subsection.
(e) Employment ceiling of Department not affected by Corps members
Corps members assigned under section 254f of
this title to provide health services in health
professional shortage areas shall not be counted
against any employment ceiling affecting the
Department.

(f) Assignment of personnel provisions inapplicable to members whose service obligation incurred under Scholarship Program or Loan
Repayment Program
Sections 215 and 217 of this title shall not
apply to members of the National Health Service Corps during their period of obligated service
under the Scholarship Program or the Loan Repayment Program, except when such members
are Commissioned Corps officers who entered
into a contract with 2 Secretary under section
254l or 254l–1 of this title after December 31, 2006
and when the Secretary determines that exercising the authority provided under section 215 or
217 of this title with respect to any such officer
to 3 would not cause unreasonable disruption to
health care services provided in the community
in which such officer is providing health care
services.
(g) Conversion from Corps member to commissioned officer; retirement credits
(1) The Secretary shall, by rule, prescribe conversion provisions applicable to any individual
who, within a year after completion of service as
a member of the Corps described in subsection
(a)(1)(C) of this section, becomes a commissioned officer in the Regular or Reserve Corps of
the Service.
(2) The rules prescribed under paragraph (1)
shall provide that in applying the appropriate
provisions of this chapter which relate to retirement, any individual who becomes such an officer shall be entitled to have credit for any period of service as a member of the Corps described in subsection (a)(1)(C) of this section.
(h) Effective administration of program
The Secretary shall ensure that adequate staff
is provided to the Service with respect to effectively administering the program for the Corps.
(i) Demonstration projects; waivers
(1) In carrying out subpart III, the Secretary
may, in accordance with this subsection, issue
waivers to individuals who have entered into a
contract for obligated service under the Scholarship Program or the Loan Repayment Program
under which the individuals are authorized to
satisfy the requirement of obligated service
through providing clinical practice that is half
time.
(2) A waiver described in paragraph (1) may be
provided by the Secretary only if—
(A) the entity for which the service is to be
performed—
(i) has been approved under section 254f–1
of this title for assignment of a Corps member; and
(ii) has requested in writing assignment of
a health professional who would serve half
time;
(B) the Secretary has determined that assignment of a health professional who would
serve half time would be appropriate for the
area where the entity is located;
(C) a Corps member who is required to perform obligated service has agreed in writing to
2 So

1 See

References in Text note below.

Page 290

3 So

in original. The word ‘‘the’’ probably should appear.
in original.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

be assigned for half-time service to an entity
described in subparagraph (A);
(D) the entity and the Corps member agree
in writing that the Corps member will perform
half-time clinical practice;
(E) the Corps member agrees in writing to
fulfill all of the service obligations under section 254m of this title through half-time clinical practice and either—
(i) double the period of obligated service
that would otherwise be required; or
(ii) in the case of contracts entered into
under section 254l–1 of this title, accept a
minimum service obligation of 2 years with
an award amount equal to 50 percent of the
amount that would otherwise be payable for
full-time service; and
(F) the Corps member agrees in writing that
if the Corps member begins providing halftime service but fails to begin or complete the
period of obligated service, the method stated
in 254o(c) of this title for determining the
damages for breach of the individual’s written
contract will be used after converting periods
of obligated service or of service performed
into their full-time equivalents.
(3) In evaluating waivers issued under paragraph (1), the Secretary shall examine the effect
of multidisciplinary teams.
(j) Definitions
For the purposes of this subpart and subpart
III:
(1) The term ‘‘Department’’ means the Department of Health and Human Services.
(2) The term ‘‘Loan Repayment Program’’
means the National Health Service Corps Loan
Repayment Program established under section
254l–1 of this title.
(3) The term ‘‘Scholarship Program’’ means
the National Health Service Corps Scholarship
Program established under section 254l of this
title.
(4) The term ‘‘State’’ includes, in addition to
the several States, only the District of Columbia, the Commonwealth of Puerto Rico, the
Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American
Samoa, and the Trust Territory of the Pacific
Islands.
(5) The terms ‘‘full time’’ and ‘‘full-time’’
mean a minimum of 40 hours per week in a
clinical practice, for a minimum of 45 weeks
per year.
(6) The terms ‘‘half time’’ and ‘‘half-time’’
mean a minimum of 20 hours per week (not to
exceed 39 hours per week) in a clinical practice, for a minimum of 45 weeks per year.
(July 1, 1944, ch. 373, title III, § 331, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2268; amended Pub. L. 97–35, title XXVII,
§ 2701, Aug. 13, 1981, 95 Stat. 902; Pub. L. 100–177,
title II, § 202(b), title III, § 301, Dec. 1, 1987, 101
Stat. 996, 1003; Pub. L. 100–607, title VI,
§ 629(a)(2), Nov. 4, 1988, 102 Stat. 3146; Pub. L.
101–597, title I, § 101, title IV, § 401(b)[(a)], Nov. 16,
1990, 104 Stat. 3013, 3035; Pub. L. 107–251, title III,
§ 301, Oct. 26, 2002, 116 Stat. 1642; Pub. L. 109–417,
title II, § 206(c)(2), Dec. 19, 2006, 120 Stat. 2853;
Pub. L. 111–148, title X, § 10501(n)(1), (2), Mar. 23,
2010, 124 Stat. 1002, 1003.)

§ 254d

REFERENCES IN TEXT
Section 294n of this title, referred to in subsec.
(d)(1)(C), was in the original a reference to section 741
of act July 1, 1944. Section 741 of that Act was omitted
in the general revision of subchapter V of this chapter
by Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106 Stat.
1994. Pub. L. 102–408 enacted a new section 776 of act
July 1, 1944, relating to acquired immune deficiency
syndrome, which was classified to section 294n of this
title, and subsequently renumbered section 2692 and
transferred to section 300ff–111 of this title.
AMENDMENTS
2010—Subsec. (i)(1). Pub. L. 111–148, § 10501(n)(1)(A),
substituted ‘‘issue waivers to individuals who have entered into a contract for obligated service under the
Scholarship Program or the Loan Repayment Program
under which the individuals are authorized to satisfy
the requirement of obligated service through providing
clinical practice that is half time’’ for ‘‘carry out demonstration projects in which individuals who have entered into a contract for obligated service under the
Loan Repayment Program receive waivers under which
the individuals are authorized to satisfy the requirement of obligated service through providing clinical
service that is not full-time’’.
Subsec.
(i)(2)(A)(ii),
(B).
Pub.
L.
111–148,
§ 10501(n)(1)(B)(i), substituted ‘‘half time’’ for ‘‘less than
full time’’.
Subsec. (i)(2)(C). Pub. L. 111–148, § 10501(n)(1)(B)(ii),
substituted ‘‘half-time service’’ for ‘‘less than full-time
service’’.
Subsec.
(i)(2)(D),
(E).
Pub.
L.
111–148,
§ 10501(n)(1)(B)(iii), amended subpars. (D) and (E) generally. Prior to amendment, subpars. (D) and (E) read as
follows:
‘‘(D) the entity and the Corps member agree in writing that the less than full-time service provided by the
Corps member will not be less than 16 hours of clinical
service per week;
‘‘(E) the Corps member agrees in writing that the period of obligated service pursuant to section 254l–1 of
this title will be extended so that the aggregate
amount of less than full-time service performed will
equal the amount of service that would be performed
through full-time service under section 254m of this
title; and’’.
Subsec. (i)(2)(F). Pub. L. 111–148, § 10501(n)(1)(B)(ii),
substituted ‘‘half-time service’’ for ‘‘less than full-time
service’’.
Subsec. (i)(3). Pub. L. 111–148, § 10501(n)(1)(C), substituted ‘‘In evaluating waivers issued under paragraph
(1)’’ for ‘‘In evaluating a demonstration project described in paragraph (1)’’.
Subsec. (j)(5), (6). Pub. L. 111–148, § 10501(n)(2), added
pars. (5) and (6).
2006—Subsec. (f). Pub. L. 109–417 inserted before period at end ‘‘, except when such members are Commissioned Corps officers who entered into a contract with
Secretary under section 254l or 254l–1 of this title after
December 31, 2006 and when the Secretary determines
that exercising the authority provided under section
215 or 217 of this title with respect to any such officer
to would not cause unreasonable disruption to health
care services provided in the community in which such
officer is providing health care services’’.
2002—Subsec. (a)(3)(E). Pub. L. 107–251, § 301(a)(1),
added subpar. (E).
Subsec. (b)(1). Pub. L. 107–251, § 301(a)(2)(A), substituted ‘‘health professions, including schools at which
graduate programs of behavioral and mental health are
offered,’’ for ‘‘health professions’’.
Subsec. (b)(2). Pub. L. 107–251, § 301(a)(2)(B), inserted
‘‘behavioral and mental health professionals,’’ after
‘‘dentists,’’.
Subsec. (c). Pub. L. 107–251, § 301(a)(3), added subsec.
(c) and struck out former subsec. (c) which read as follows: ‘‘The Secretary may reimburse applicants for positions in the Corps (including individuals considering

§ 254d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

entering into a written agreement pursuant to section
254n of this title) for actual and reasonable expenses incurred in traveling to and from their places of residence to a health professional shortage area (designated under section 254e of this title) in which they
may be assigned for the purpose of evaluating such area
with regard to being assigned in such area. The Secretary shall not reimburse an applicant for more than
one such trip.’’
Subsecs. (i), (j). Pub. L. 107–251, § 301(b), added subsec.
(i) and redesignated former subsec. (i) as (j).
1990—Subsec. (a). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area in pars.
(1), (2), and (3)(C).
Pub. L. 101–597, § 101(a), designated existing provisions
as par. (1), substituted ‘‘For the purpose of eliminating
health manpower shortages in health manpower shortage areas, there is established, within the Service, the
National Health Service Corps, which shall consist of—
’’ for ‘‘There is established, within the Service, the National Health Service Corps (hereinafter in this subpart
referred to as the ‘Corps’) which (1) shall consist of—’’,
substituted ‘‘States.’’ for ‘‘States,’’ at end of subpar.
(C), struck out closing provisions which read ‘‘(such officers, employees, and individuals hereinafter in this
subpart referred to as ‘Corps members’), and (2) shall be
utilized by the Secretary to improve the delivery of
health services in health manpower shortage areas as
defined in section 254e(a) of this title.’’, and added pars.
(2) and (3).
Subsec. (b). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (2).
Pub. L. 101–597, § 101(b), designated existing provision
as par. (1), inserted at end ‘‘Such recruiting programs
shall include efforts to recruit individuals who will
serve in the Corps other than pursuant to obligated
service under the Scholarship or Loan Repayment Program.’’, and added par. (2).
Subsec. (c). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Subsec. (d)(1). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in introductory provisions and in subpar. (C).
Subsec. (d)(1)(A). Pub. L. 101–597, § 101(c), struck out
‘‘(not to exceed $1,000)’’ after ‘‘by an amount’’.
Subsecs. (d)(2), (e). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area.
Subsec. (h). Pub. L. 101–597, § 101(d), added subsec. (h)
and struck out former subsec. (h) which read as follows:
‘‘In assigning members of the Corps to health manpower shortage areas, to the extent practicable, the
Secretary shall—
‘‘(1) give priority to meeting the needs of the Indian
Health Service and the needs of health programs or
facilities operated by tribes or tribal organizations
under the Indian Self-Determination Act (25 U.S.C.
450f et seq.); and
‘‘(2) provide special consideration to the homeless
populations who do not have access to primary health
care services.’’
Subsec. (i). Pub. L. 101–597, § 101(e), substituted ‘‘of
this subpart and subpart III’’ for ‘‘of this subpart’’.
1988—Subsec. (b). Pub. L. 100–607 substituted ‘‘osteopathic medicine’’ for ‘‘osteopathy’’.
1987—Subsec. (b). Pub. L. 100–177, § 202(b)(1), inserted
reference to Loan Repayment Program.
Subsec. (c). Pub. L. 100–177, § 202(b)(2), made technical
amendment to reference to section 254n of this title to
reflect renumbering of corresponding section of original act.
Subsecs. (d)(2), (f). Pub. L. 100–177, § 202(b)(3), (4), inserted reference to Loan Repayment Program.
Subsec. (h). Pub. L. 100–177, § 301(2), added subsec. (h).
Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 100–177, §§ 202(b)(5), 301(1), redesignated subsec. (h) as (i), added par. (2), and redesignated
former pars. (2) and (3) as (3) and (4), respectively.

Page 292

1981—Subsec. (a)(1). Pub. L. 97–35, § 2701(a), revised
provisions and, as so revised, set out existing provisions in cls. (A) and (B), and added cl. (C).
Subsec. (b). Pub. L. 97–35, § 2701(b), substituted ‘‘may’’
for ‘‘shall’’.
Subsec. (c). Pub. L. 97–35, § 2701(c), inserted provisions
respecting a written agreement under section 254n of
this title.
Subsec. (d). Pub. L. 97–35, § 2701(d), in par. (1) inserted
reference to member described in subsec. (a)(1)(C) of
this section, in subpars. (1)(A) and (B) substituted
‘‘may’’ for ‘‘shall’’, and added par. (3).
Subsec. (g). Pub. L. 97–35, § 2701(e), substituted provisions relating to conversion from Corps member to
commissioned officer and retirement credits, for provisions relating to school participation in development of
administrative guidelines.
Subsec. (h). Pub. L. 97–35, § 2701(f), in par. (1) substituted ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’, in par. (2) substituted ‘‘254l’’
for ‘‘294t’’, and in par. (3) inserted reference to Commonwealth with respect to the Northern Mariana Islands.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 501 of Pub. L. 101–597 provided that: ‘‘This Act
and the amendments made by this Act [enacting sections 254f–1, 254o–1, and 254r of this title, amending this
section, sections 242a, 254e to 254i, 254k, 254l to 254q–1,
254s, 294h, 294n, 294aa, 295g–1, 296m, 1320c–5, 1395l, 1395u,
1395x, 3505d, and 9840 of this title, and section 2123 of
Title 10, Armed Forces, and enacting provisions set out
as notes under sections 201, 254l–1, and 254o of this title]
shall take effect October 1, 1990, or upon the date of the
enactment of this Act [Nov. 16, 1990], whichever occurs
later.’’
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
SPECIAL REPORT ON PRESENT AND FUTURE DIRECTION
OF NATIONAL HEALTH SERVICE CORPS; SUBMISSION TO
CONGRESS NOT LATER THAN FEBRUARY 1, 1979
Pub. L. 95–626, title I, § 116(c), Nov. 10, 1978, 92 Stat.
3569, directed Secretary, not later than Feb. 1, 1979, in
consultation with National Advisory Council of National Health Service Corps and National Advisory
Council on Health Professions Education, to submit to
Congress a report on the direction of the National
Health Service Corps, particularly its role as a health
manpower program and as a health services delivery
program, the use of members of the Corps in health
manpower shortage areas to meet urban and rural
health needs, the types of health professions needed to
meet urban and rural health needs, and the projected
size, composition, and use of the Corps through 1985.
EFFECTIVE DATE; OTHER PROVISIONS: HEALTH MANPOWER SHORTAGE AREA; APPROVAL OF APPLICATIONS
FOR ASSIGNMENT OF CORPS PERSONNEL; ASSIGNMENT
PERIOD, COMMENCEMENT; CREDIT FOR MONTHS OF
PRIOR HEALTH CARE AND SERVICES FOR ADDITIONAL
PAY BENEFIT; NATIONAL ADVISORY COUNCIL ON THE
NATIONAL HEALTH SERVICE CORPS, CONTINUATION OF
COUNCIL AND APPOINTMENT OF MEMBERS
Pub. L. 94–484, title IV, § 407(c), Oct. 12, 1976, 90 Stat.
2278, provided that:
‘‘(1) The amendment made by subsections (a) and (b)
[enacting this subpart and repealing section 254b of this
title] shall apply only with respect to fiscal years beginning after September 30, 1977, except that the Secretary of Health, Education, and Welfare [now Health
and Human Services] shall carry out the activities described in section 332 of the Public Health Service Act
(as added by such amendment) [section 254e of this
title] after the date of enactment of this Act [Oct. 12,
1976].

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2)(A) Any area for which a designation under section 329(b) of the Public Health Service Act (as in effect
on September 30, 1977) [former section 254b(b) of this
title] was in effect on such date and in which National
Health Service Corps personnel were, on such date, providing, under an assignment made under such section
(as so in effect), health care and services for persons residing in such area shall, effective October 1, 1977, be
considered under subpart II of part C of title III of such
Act (as added by subsection (b) of this section) [this
subpart] to (i) be designated a health manpower shortage area (as defined by section 332 of such Act (as so
added)) [section 254e of this title], and (ii) have had an
application approved under section 333 of such Act (as
so added)) [section 254f of this title] for the assignment
of Corps personnel unless, as determined under subparagraph (B) of this paragraph, the assignment period
applicable to such area (within the meaning of section
334 (as so added)) [former section 254g of this title] has
expired.
‘‘(B) The assignment period (within the meaning of
such section 334) [former section 254g of this title] applicable to an area described in subparagraph (A) of
this paragraph shall be considered to have begun on the
date Corps personnel were first assigned to such area
under section 329 of such Act (as in effect on September
30, 1977) [former section 254b of this title].
‘‘(C) In the case of any physician or dentist member
of the Corps who was providing health care and services
on September 30, 1977, under an assignment made under
section 329(b) of such Act (as in effect on September 30,
1977) [former section 254b(b) of this title], the number of
the months during which such member provided such
care and services before October 1, 1977, shall be counted in determining the application of the additional pay
provisions of section 331(d) of such Act (as added by
subsection (b) of this section) [subsec. (d) of this section] to such number.
‘‘(3) The amendment made by subsection (b) which established an Advisory Council previously established
under section 329 of the Public Health Service Act
[former section 254b of this title] shall not be construed
as requiring the establishment of a new Advisory Council under such section 337 [section 254j of this title], and
the amendment made by such subsection with respect
to the composition of such Advisory Council shall
apply with respect to appointments made to the Advisory Council after October 1, 1977, and the Secretary of
Health, Education, and Welfare [now Health and
Human Services] shall make appointments to the Advisory Council after such date in a manner which will
bring about, at the earliest feasible time, the Advisory
Council composition prescribed by the amendment.’’

§ 254e. Health professional shortage areas
(a) Designation by Secretary; removal from areas
designated; ‘‘medical facility’’ defined
(1) For purposes of this subpart the term
‘‘health professional shortage area’’ means (A)
an area in an urban or rural area (which need
not conform to the geographic boundaries of a
political subdivision and which is a rational
area for the delivery of health services) which
the Secretary determines has a health manpower shortage and which is not reasonably accessible to an adequately served area, (B) a population group which the Secretary determines
has such a shortage, or (C) a public or nonprofit
private medical facility or other public facility
which the Secretary determines has such a
shortage. All Federally qualified health centers
and rural health clinics, as defined in section
1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa)), that meet the requirements of section
254g of this title shall be automatically designated as having such a shortage. The Sec-

§ 254e

retary shall not remove an area from the areas
determined to be health professional shortage
areas under subparagraph (A) of the preceding
sentence until the Secretary has afforded interested persons and groups in such area an opportunity to provide data and information in support of the designation as a health professional
shortage area or a population group described in
subparagraph (B) of such sentence or a facility
described in subparagraph (C) of such sentence,
and has made a determination on the basis of
the data and information submitted by such persons and groups and other data and information
available to the Secretary.
(2) For purposes of this subsection, the term
‘‘medical facility’’ means a facility for the delivery of health services and includes—
(A) a hospital, State mental hospital, public
health center, outpatient medical facility, rehabilitation facility, facility for long-term
care, community mental health center, migrant health center, facility operated by a city
or county health department, and community
health center;
(B) such a facility of a State correctional institution or of the Indian Health Service, and
a health program or facility operated by a
tribe or tribal organization under the Indian
Self-Determination Act [25 U.S.C. 450f et seq.];
(C) such a facility used in connection with
the delivery of health services under section
248 of this title (relating to hospitals), 249 of
this title (relating to care and treatment of
persons under quarantine and others), 250 of
this title (relating to care and treatment of
Federal prisoners), 251 of this title (relating to
examination and treatment of certain Federal
employees), 252 of this title (relating to examination of aliens), 253 of this title (relating to
services to certain Federal employees), 247e of
this title (relating to services for persons with
Hansen’s disease), or 254b(h) of this title (relating to the provision of health services to
homeless individuals); and
(D) a Federal medical facility.
(3) Homeless individuals (as defined in section
254b(h)(5) of this title), seasonal agricultural
workers (as defined in section 254b(g)(3) of this
title) and migratory agricultural workers (as so
defined)), and residents of public housing (as defined in section 1437a(b)(1) of this title) may be
population groups under paragraph (1).
(b) Criteria for designation of health professional shortage areas; promulgation of regulations
The Secretary shall establish by regulation
criteria for the designation of areas, population
groups, medical facilities, and other public facilities, in the States, as health professional
shortage areas. In establishing such criteria, the
Secretary shall take into consideration the following:
(1) The ratio of available health manpower
to the number of individuals in an area or population group, or served by a medical facility
or other public facility under consideration for
designation.
(2) Indicators of a need, notwithstanding the
supply of health manpower, for health services
for the individuals in an area or population

§ 254e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

group or served by a medical facility or other
public facility under consideration for designation.
(3) The percentage of physicians serving an
area, population group, medical facility, or
other public facility under consideration for
designation who are employed by hospitals
and who are graduates of foreign medical
schools.
(c) Considerations in determination of designation
In determining whether to make a designation, the Secretary shall take into consideration
the following:
(1) The recommendations of the Governor of
each State in which the area, population
group, medical facility, or other public facility under consideration for designation is in
whole or part located.
(2) The extent to which individuals who are
(A) residents of the area, members of the population group, or patients in the medical facility or other public facility under consideration for designation, and (B) entitled to have
payment made for medical services under title
XVIII, XIX, or XXI of the Social Security Act
[42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et
seq.], cannot obtain such services because of
suspension of physicians from the programs
under such titles.
(d) Designation; publication of descriptive lists
(1) In accordance with the criteria established
under subsection (b) of this section and the considerations listed in subsection (c) of this section the Secretary shall designate health professional shortage areas in the States, publish a descriptive list of the areas, population groups,
medical facilities, and other public facilities so
designated, and at least annually review and, as
necessary, revise such designations.
(2) For purposes of paragraph (1), a complete
descriptive list shall be published in the Federal
Register not later than July 1 of 1991 and each
subsequent year.
(e) Notice of proposed designation of areas and
facilities; time for comment
(1) Prior to the designation of a public facility,
including a Federal medical facility, as a health
professional shortage area, the Secretary shall
give written notice of such proposed designation
to the chief administrative officer of such facility and request comments within 30 days with
respect to such designation.
(2) Prior to the designation of a health professional shortage area under this section, the Secretary shall, to the extent practicable, give
written notice of the proposed designation of
such area to appropriate public or private nonprofit entities which are located or have a demonstrated interest in such area and request comments from such entities with respect to the
proposed designation of such area.
(f) Notice of designation
The Secretary shall give written notice of the
designation of a health professional shortage
area, not later than 60 days from the date of
such designation, to—
(1) the Governor of each State in which the
area, population group, medical facility, or

Page 294

other public facility so designated is in whole
or part located; and
(2) appropriate public or nonprofit private
entities which are located or which have a
demonstrated interest in the area so designated.
(g) Recommendations to Secretary
Any person may recommend to the Secretary
the designation of an area, population group,
medical facility, or other public facility as a
health professional shortage area.
(h) Public information programs in designated
areas
The Secretary may conduct such information
programs in areas, among population groups,
and in medical facilities and other public facilities designated under this section as health professional shortage areas as may be necessary to
inform public and nonprofit private entities
which are located or have a demonstrated interest in such areas of the assistance available
under this subchapter by virtue of the designation of such areas.
(i) Dissemination
The Administrator of the Health Resources
and Services Administration shall disseminate
information concerning the designation criteria
described in subsection (b) of this section to—
(1) the Governor of each State;
(2) the representative of any area, population group, or facility selected by any such
Governor to receive such information;
(3) the representative of any area, population group, or facility that requests such information; and
(4) the representative of any area, population group, or facility determined by the Administrator to be likely to meet the criteria
described in subsection (b) of this section.
(j) Regulations and report
(1) The Secretary shall submit the report described in paragraph (2) if the Secretary, acting
through the Administrator of the Health Resources and Services Administration, issues—
(A) a regulation that revises the definition
of a health professional shortage area for purposes of this section; or
(B) a regulation that revises the standards
concerning priority of such an area under section 254f–1 of this title.
(2) On issuing a regulation described in paragraph (1), the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that describes the
regulation.
(3) Each regulation described in paragraph (1)
shall take effect 180 days after the committees
described in paragraph (2) receive a report referred to in such paragraph describing the regulation.
(July 1, 1944, ch. 373, title III, § 332, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2270; amended Pub. L. 95–142, § 7(d), Oct. 25,
1977, 91 Stat. 1193; Pub. L. 96–32, § 7(d), July 10,
1979, 93 Stat. 84; Pub. L. 97–35, title IX, § 986(b)(4),

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

title XXVII, § 2702(a), (b), (c), Aug. 13, 1981, 95
Stat. 603, 903, 904; Pub. L. 100–77, title VI, § 602,
July 22, 1987, 101 Stat. 515; Pub. L. 100–177, title
III, § 302, Dec. 1, 1987, 101 Stat. 1003; Pub. L.
100–607, title VIII, § 802(b)(2), Nov. 4, 1988, 102
Stat. 3169; Pub. L. 100–628, title VI, § 602(b)(2),
Nov. 7, 1988, 102 Stat. 3242; Pub. L. 101–597, title
I, § 102, title IV, § 401(b)[(a)], Nov. 16, 1990, 104
Stat. 3014, 3035; Pub. L. 107–251, title III, § 302(a),
(d)(2), title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1643, 1645, 1664; Pub. L. 108–163, § 2(f)(1), Dec. 6,
2003, 117 Stat. 2021; Pub. L. 110–355, § 3(b), Oct. 8,
2008, 122 Stat. 3993.)
REFERENCES IN TEXT
The Indian Self-Determination Act, referred to in
subsec. (a)(2)(B), is title I of Pub. L. 93–638, Jan. 4, 1975,
88 Stat. 2206, which is classified principally to part A
(§ 450f et seq.) of subchapter II of chapter 14 of Title 25,
Indians. For complete classification of this Act to the
Code, see Short Title note set out under section 450 of
Title 25 and Tables.
The Social Security Act, referred to in subsec. (c)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Titles XVIII, XIX, and XXI of the Act are classified
generally to subchapters XVIII (§ 1395 et seq.), XIX
(§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively,
of chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
PRIOR PROVISIONS
A prior section 332 of act July 1, 1944, was renumbered
section 340, and was classified to section 256 of this title
prior to repeal by Pub. L. 95–626.
AMENDMENTS
2008—Subsec. (a)(1). Pub. L. 110–355 struck out ‘‘Not
earlier than 6 years after such date of designation, and
every 6 years thereafter, each such center or clinic
shall demonstrate that the center or clinic meets the
applicable requirements of the Federal regulations regarding the definition of a health professional shortage
area for purposes of this section.’’ before ‘‘The Secretary shall not’’.
2003—Subsec. (a)(1). Pub. L. 108–163, § 2(f)(1)(A), substituted ‘‘such date of designation’’ for ‘‘such date of
enactment’’ and ‘‘regarding’’ for ‘‘, issued after the
date of enactment of this Act, that revise’’.
Subsec. (a)(3). Pub. L. 108–163, § 2(f)(1)(B), substituted
‘‘254b(h)(5)’’ for ‘‘254b(h)(4)’’.
Subsec. (b)(2). Pub. L. 108–163, § 2(f)(1)(C), struck out
comma before period at end.
Subsec. (j). Pub. L. 108–163, § 2(f)(1)(D), added subsec.
(j).
2002—Subsec. (a)(1). Pub. L. 107–251, § 302(a)(1)(A), inserted after first sentence ‘‘All Federally qualified
health centers and rural health clinics, as defined in
section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa)), that meet the requirements of section 254g
of this title shall be automatically designated as having such a shortage. Not earlier than 6 years after such
date of enactment, and every 6 years thereafter, each
such center or clinic shall demonstrate that the center
or clinic meets the applicable requirements of the Federal regulations, issued after the date of enactment of
this Act, that revise the definition of a health professional shortage area for purposes of this section.’’
Subsec. (a)(2)(C). Pub. L. 107–251, § 601(a), substituted
‘‘254b(h)’’ for ‘‘256’’.
Subsec. (a)(3). Pub. L. 107–251, § 302(a)(1)(B), substituted ‘‘254b(h)(4) of this title), seasonal agricultural
workers (as defined in section 254b(g)(3) of this title)
and migratory agricultural workers (as so defined)),
and residents of public housing (as defined in section
1437a(b)(1) of this title) may be population groups’’ for
‘‘256(r) of this title) may be a population group’’.

§ 254e

Subsec. (b)(2). Pub. L. 107–251, § 302(a)(2), struck out
after ‘‘designation,’’ the following: ‘‘with special consideration to indicators of—
‘‘(A) infant mortality,
‘‘(B) access to health services,
‘‘(C) health status, and
‘‘(D) ability to pay for health services’’.
Subsec. (c)(2)(B). Pub. L. 107–251, § 302(a)(3), substituted ‘‘XVIII, XIX, or XXI of the Social Security
Act’’ for ‘‘XVIII or XIX of the Social Security Act’’.
Subsec. (i). Pub. L. 107–251, § 302(d)(2), added subsec.
(i).
1990—Subsec. (a)(1). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area wherever appearing.
Subsec. (a)(2)(A). Pub. L. 101–597, § 102(b)(1), inserted
‘‘facility operated by a city or county health department,’’ before ‘‘and community health center’’.
Subsec. (a)(2)(B). Pub. L. 101–597, § 102(b)(2), inserted
before semicolon ‘‘, and a health program or facility
operated by a tribe or tribal organization under the Indian Self-Determination Act’’.
Subsec. (a)(2)(C). Pub. L. 101–597, § 102(b)(3), substituted ‘‘section’’ for ‘‘sections’’ before ‘‘248’’, struck
out ‘‘or’’ before ‘‘253’’ and ‘‘or section’’ before ‘‘247e’’,
and inserted before semicolon ‘‘, or 256 of this title (relating to the provision of health services to homeless
individuals)’’.
Subsec. (b). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Pub. L. 101–597, § 102(c)(1), struck out ‘‘, promulgated
not later than May 1, 1977,’’ after ‘‘establish by regulation’’.
Subsec. (c). Pub. L. 101–597, § 102(c)(2), redesignated
pars. (2) and (3) as (1) and (2), respectively, and struck
out former par. (1) which read as follows:
‘‘(A) The recommendations of each health systems
agency (designated under section 300l–4 of this title) for
a health service area which includes all or any part of
the area, population group, medical facility, or other
public facility under consideration for designation.
‘‘(B) The recommendations of the State health planning and development agency (designated under section
300m of this title) if such area, population group, medical facility, or other public facility is within a health
service area for which no health systems agency has
been designated.’’
Subsec. (d). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (1).
Pub. L. 101–597, § 102(a), (c)(3), designated existing provision as par. (1), struck out ‘‘, not later than November 1, 1977,’’ after ‘‘Secretary shall designate’’, and
added par. (2).
Subsec. (e). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area wherever appearing.
Subsec. (f). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Pub. L. 101–597, § 102(c)(4), redesignated par. (3) as (2)
and struck out former par. (2) which read as follows:
‘‘(A) each health systems agency (designated under
section 300l–4 of this title) for a health service area
which includes all or any part of the area, population
group, medical facility, or other public facility so designated; or
‘‘(B) the State health planning and development
agency of the State (designated under section 300m of
this title) if there is a part of such area, population
group, medical facility, or other public facility within
a health service area for which no health systems agency has been designated; and’’.
Subsecs. (g), (h). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area.
1988—Subsec. (a)(3). Pub. L. 100–607 and Pub. L. 100–628
made identical amendments, substituting ‘‘section
256(r)’’ for ‘‘section 256(q)(2)’’.

§ 254f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1987—Subsec. (a)(1). Pub. L. 100–177, § 302(1), inserted
sentence at end relating to removal of an area from
areas determined to be health manpower shortage
areas.
Subsec. (a)(3). Pub. L. 100–77 added par. (3).
Subsec. (b)(2)(D). Pub. L. 100–177, § 302(2), added subpar. (D).
1981—Subsec. (a)(1)(A). Pub. L. 97–35, § 2702(a), inserted provisions respecting reasonable accessibility to
adequately served area.
Subsec. (a)(2)(C). Pub. L. 97–35, § 986(b)(4), substituted
‘‘persons under quarantine’’ for ‘‘seamen’’.
Subsec. (e). Pub. L. 97–35, § 2702(c), designated existing
provisions as par. (1) and added par. (2).
Subsec. (h). Pub. L. 97–35, § 2702(b), substituted ‘‘may’’
for ‘‘shall’’.
1979—Subsec. (a)(2)(C). Pub. L. 96–32 substituted ‘‘section 247e of this title’’ for ‘‘part D of subchapter II of
this chapter’’.
1977—Subsec. (c)(3). Pub. L. 95–142 added par. (3).
EFFECTIVE DATE OF 2003 AMENDMENT
Amendments by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1988 AMENDMENTS
Section 631 of title VI of Pub. L. 100–628 provided
that: ‘‘The amendments made by subsection (a) of section 601 [amending section 256 of this title] shall take
effect in accordance with subsection (b) of such section
[formerly set out as a note under section 256 of this
title]. The amendments otherwise made by this title
[amending this section and sections 256, 290bb–2,
290cc–21, 290cc–28, 290cc–29, 290cc–35, 290cc–36, 290dd,
290ee, and 290ee–1 of this title and amending provisions
set out as a note under section 290aa–3 of this title]
shall take effect October 1, 1988, or upon the date of the
enactment of this Act [Nov. 7, 1988], whichever occurs
later.’’
Section 831 of title VIII of Pub. L. 100–607 provided
that: ‘‘The amendments made by subsection (a) of section 801 [amending section 256 of this title] shall take
effect in accordance with subsection (b) of such section
[formerly set out as a note under section 256 of this
title]. The amendments otherwise made by this title
[amending this section and sections 256, 290bb–2,
290cc–21, 290cc–28, 290cc–29, 290cc–35, 290cc–36, 290dd,
290ee, and 290ee–1 of this title and amending provisions
set out as a note under section 290aa–3 of this title]
shall take effect October 1, 1988, or upon the date of the
enactment of this Act [Nov. 4, 1988], whichever occurs
later.’’
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by section 986(b)(4) of Pub. L. 97–35 effective Oct. 1, 1981, see section 986(c) of Pub. L. 97–35, set
out as a note under section 249 of this title.
EFFECTIVE DATE OF 1977 AMENDMENT
Section 7(e)(1) of Pub. L. 95–142 provided that: ‘‘The
amendment made by subsection (d) [amending this section] shall apply with respect to determinations and
designations made on and after the date of the enactment of this Act [Oct. 25, 1977].’’
REGULATIONS
Pub. L. 107–251, title III, § 302(b), Oct. 26, 2002, 116 Stat.
1644, which required the Secretary to submit a report
to Congress, if the Secretary issued regulations revising the definition of a health professional shortage area
under this section and standards concerning priority of
such an area under section 254f–1 of this title, was repealed by Pub. L. 108–163, § 2(f)(2), Dec. 6, 2003, 117 Stat.
2022.
IMPROVEMENT OF SITE DESIGNATION PROCESS
Pub. L. 107–251, title III, § 302(d)(1), Oct. 26, 2002, 116
Stat. 1644, provided that: ‘‘The Administrator of the

Page 296

Health Resources and Services Administration, in consultation with the Association of State and Territorial
Dental Directors, dental societies, and other interested
parties, shall revise the criteria on which the designations of dental health professional shortage areas are
based so that such criteria provide a more accurate reflection of oral health care need, particularly in rural
areas.’’
GAO STUDY
Pub. L. 107–251, title III, § 302(e), Oct. 26, 2002, 116 Stat.
1645, provided that: ‘‘Not later than February 1, 2005,
the Comptroller General of the United States shall submit to the Congress a report on the appropriateness of
the criteria, including but not limited to infant mortality rates, access to health services taking into account
the distance to primary health services, the rate of
poverty and ability to pay for health services, and low
birth rates, established by the Secretary of Health and
Human Services for the designation of health professional shortage areas and whether the deeming of federally qualified health centers and rural health clinics as
such areas is appropriate and necessary.’’
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center, considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
EVALUATION OF CRITERIA USED TO DESIGNATE HEALTH
MANPOWER SHORTAGE AREAS; REPORT TO CONGRESS
Section 2702(c) of Pub. L. 97–35 directed the Secretary
of Health and Human Services, effective Oct. 1, 1981, to
evaluate the criteria used under section 254e(b) of this
title to determine if the use of the criteria resulted in
areas which did not have a shortage of health professions personnel being designated as health manpower
shortage areas, and to consider different criteria (including the actual use of health professions personnel
in an area by the residents, taking into account their
health status and indicators of unmet demand and likelihood that such demand would not be met in two
years) which might be used to designate health manpower shortage areas. The Secretary was to report the
results of his activities to Congress not later than Nov.
30, 1982.

§ 254f. Corps personnel
(a) Conditions necessary for assignment of Corps
personnel to area; contents of application for
assignment; assignment to particular facility;
approval of applications
(1) The Secretary may assign members of the
Corps to provide, under regulations promulgated
by the Secretary, health services in or to a
health professional shortage area during the assignment period only if—
(A) a public or private entity, which is located or has a demonstrated interest in such
area makes application to the Secretary for
such assignment;
(B) such application has been approved by
the Secretary;
(C) the entity agrees to comply with the requirements of section 254g of this title; and
(D) the Secretary has (i) conducted an evaluation of the need and demand for health manpower for the area, the intended use of Corps
members to be assigned to the area, community support for the assignment of Corps members to the area, the area’s efforts to secure

Page 297

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health manpower for the area, and the fiscal
management capability of the entity to which
Corps members would be assigned and (ii) on
the basis of such evaluation has determined
that—
(I) there is a need and demand for health
manpower for the area;
(II) there has been appropriate and efficient use of any Corps members assigned to
the entity for the area;
(III) there is general community support
for the assignment of Corps members to the
entity;
(IV) the area has made unsuccessful efforts
to secure health manpower for the area;
(V) there is a reasonable prospect of sound
fiscal management, including efficient collection of fee-for-service, third-party, and
other appropriate funds, by the entity with
respect to Corps members assigned to such
entity; and
(VI) the entity demonstrates willingness
to support or facilitate mentorship, professional development, and training opportunities for Corps members.
An application for assignment of a Corps member to a health professional shortage area shall
include a demonstration by the applicant that
the area or population group to be served by the
applicant has a shortage of personal health services and that the Corps member will be located
so that the member will provide services to the
greatest number of persons residing in such area
or included in such population group. Such a
demonstration shall be made on the basis of the
criteria prescribed by the Secretary under section 254e(b) of this title and on additional criteria which the Secretary shall prescribe to determine if the area or population group to be
served by the applicant has a shortage of personal health services.
(2) Corps members may be assigned to a Federal health care facility, but only upon the request of the head of the department or agency of
which such facility is a part.
(3) In approving applications for assignment of
members of the Corps the Secretary shall not
discriminate against applications from entities
which are not receiving Federal financial assistance under this chapter. In approving such applications, the Secretary shall give preference to
applications in which a nonprofit entity or public entity shall provide a site to which Corps
members may be assigned.
(b) Corps member income assurances; grants respecting sufficiency of financial resources
(1) The Secretary may not approve an application for the assignment of a member of the
Corps described in subparagraph (C) of section
254d(a)(1) of this title to an entity unless the application of the entity contains assurances satisfactory to the Secretary that the entity (A)
has sufficient financial resources to provide the
member of the Corps with an income of not less
than the income to which the member would be
entitled if the member was a member described
in subparagraph (B) of section 254d(a)(1) of this
title, or (B) would have such financial resources
if a grant was made to the entity under paragraph (2).

§ 254f

(2)(A) If in approving an application of an entity for the assignment of a member of the
Corps described in subparagraph (C) of section
254d(a)(1) of this title the Secretary determines
that the entity does not have sufficient financial resources to provide the member of the
Corps with an income of not less than the income to which the member would be entitled if
the member was a member described in subparagraph (B) of section 254d(a)(1) of this title, the
Secretary may make a grant to the entity to assure that the member of the Corps assigned to it
will receive during the period of assignment to
the entity such an income.
(B) The amount of any grant under subparagraph (A) shall be determined by the Secretary.
Payments under such a grant may be made in
advance or by way of reimbursement, and at
such intervals and on such conditions, as the
Secretary finds necessary. No grant may be
made unless an application therefor is submitted to and approved by the Secretary. Such an
application shall be in such form, submitted in
such manner, and contain such information, as
the Secretary shall by regulation prescribe.
(c) Assignment of members without regard to
ability of area to pay for services
The Secretary shall assign Corps members to
entities in health professional shortage areas
without regard to the ability of the individuals
in such areas, population groups, medical facilities, or other public facilities to pay for such
services.
(d) Entities entitled to aid; forms of assistance;
coordination of efforts; agreements for assignment of Corps members; qualified entity
(1) The Secretary may provide technical assistance to a public or private entity which is
located in a health professional shortage area
and which desires to make an application under
this section for assignment of a Corps member
to such area. Assistance provided under this
paragraph may include assistance to an entity
in (A) analyzing the potential use of health professions personnel in defined health services delivery areas by the residents of such areas, (B)
determining the need for such personnel in such
areas, (C) determining the extent to which such
areas will have a financial base to support the
practice of such personnel and the extent to
which additional financial resources are needed
to adequately support the practice, (D) determining the types of inpatient and other health
services that should be provided by such personnel in such areas, and (E) developing long-term
plans for addressing health professional shortages and improving access to health care. The
Secretary shall encourage entities that receive
technical assistance under this paragraph to
communicate with other communities, State Offices of Rural Health, State Primary Care Associations and Offices, and other entities concerned with site development and community
needs assessment.
(2) The Secretary may provide, to public and
private entities which are located in a health
professional shortage area to which area a Corps
member has been assigned, technical assistance
to assist in the retention of such member in
such area after the completion of such member’s
assignment to the area.

§ 254f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) The Secretary may provide, to health professional shortage areas to which no Corps member has been assigned, (A) technical assistance
to assist in the recruitment of health manpower
for such areas, and (B) current information on
public and private programs which provide assistance in the securing of health manpower.
(4)(A) The Secretary shall undertake to demonstrate the improvements that can be made in
the assignment of members of the Corps to
health professional shortage areas and in the delivery of health care by Corps members in such
areas through coordination with States, political subdivisions of States, agencies of States
and political subdivisions, and other public and
private entities which have expertise in the
planning, development, and operation of centers
for the delivery of primary health care. In carrying out this subparagraph, the Secretary shall
enter into agreements with qualified entities
which provide that if—
(i) the entity places in effect a program for
the planning, development, and operation of
centers for the delivery of primary health care
in health professional shortage areas which
reasonably addresses the need for such care in
such areas, and
(ii) under the program the entity will perform the functions described in subparagraph
(B),
the Secretary will assign under this section
members of the Corps in accordance with the
program.
(B) For purposes of subparagraph (A), the term
‘‘qualified entity’’ means a State, political subdivision of a State, an agency of a State or political subdivision, or other public or private entity operating solely within one State, which
the Secretary determines is able—
(i) to analyze the potential use of health professions personnel in defined health services
delivery areas by the residents of such areas;
(ii) to determine the need for such personnel
in such areas and to recruit, select, and retain
health professions personnel (including members of the National Health Service Corps) to
meet such need;
(iii) to determine the extent to which such
areas will have a financial base to support the
practice of such personnel and the extent to
which additional financial resources are needed to adequately support the practice;
(iv) to determine the types of inpatient and
other health services that should be provided
by such personnel in such areas;
(v) to assist such personnel in the development of their clinical practice and fee schedules and in the management of their practice;
(vi) to assist in the planning and development of facilities for the delivery of primary
health care; and
(vii) to assist in establishing the governing
bodies of centers for the delivery of such care
and to assist such bodies in defining and carrying out their responsibilities.
(e) Practice within State by Corps member
Notwithstanding any other law, any member
of the Corps licensed to practice medicine, osteopathic medicine, dentistry, or any other
health profession in any State shall, while serv-

Page 298

ing in the Corps, be allowed to practice such
profession in any State.
(July 1, 1944, ch. 373, title III, § 333, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2272; amended Pub. L. 97–35, title XXVII,
§ 2703, Aug. 13, 1981, 95 Stat. 904; Pub. L. 100–177,
title III, §§ 303, 304, Dec. 1, 1987, 101 Stat. 1004;
Pub. L. 100–607, title VI, § 629(a)(2), Nov. 4, 1988,
102 Stat. 3146; Pub. L. 101–597, title I, § 103, title
IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3015, 3035;
Pub. L. 107–251, title III, § 303, Oct. 26, 2002, 116
Stat. 1645; Pub. L. 108–163, § 2(g), Dec. 6, 2003, 117
Stat. 2022; Pub. L. 110–355, § 3(c), Oct. 8, 2008, 122
Stat. 3993.)
AMENDMENTS
2008—Subsec. (a)(1)(D)(ii)(VI). Pub. L. 110–355 added
subcl. (VI).
2003—Subsec. (a)(1)(C). Pub. L. 108–163 realigned margin.
2002—Subsec. (a)(1). Pub. L. 107–251, § 303(1)(A)(i),
struck out ‘‘(specified in the agreement described in
section 254g of this title)’’ after ‘‘assignment period’’ in
introductory provisions.
Subsec. (a)(1)(A). Pub. L. 107–251, § 303(1)(A)(ii), struck
out ‘‘nonprofit’’ before ‘‘private entity’’.
Subsec. (a)(1)(C). Pub. L. 107–251, § 303(1)(A)(iii), added
subpar. (C) and struck out former subpar. (C) which
read as follows: ‘‘an agreement has been entered into
between the entity which has applied and the Secretary, in accordance with section 254g of this title;
and’’.
Subsec. (a)(3). Pub. L. 107–251, § 303(1)(B), inserted at
end ‘‘In approving such applications, the Secretary
shall give preference to applications in which a nonprofit entity or public entity shall provide a site to
which Corps members may be assigned.’’
Subsec. (d)(1). Pub. L. 107–251, § 303(2), struck out
‘‘nonprofit’’ before ‘‘private entity’’ in first sentence,
added cl. (E), and inserted at end ‘‘The Secretary shall
encourage entities that receive technical assistance
under this paragraph to communicate with other communities, State Offices of Rural Health, State Primary
Care Associations and Offices, and other entities concerned with site development and community needs assessment.’’
Subsec. (d)(2). Pub. L. 107–251, § 303(2)(A), struck out
‘‘nonprofit’’ before ‘‘private entities’’.
Subsec. (d)(4). Pub. L. 107–251, § 303(2)(A), struck out
‘‘nonprofit’’ before ‘‘private entities’’ in introductory
provisions of subpar. (A) and before ‘‘private entity’’ in
introductory provisions of subpar. (B).
1990—Subsec. (a)(1). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area in introductory and closing provisions.
Subsec. (a)(1)(D)(ii)(II). Pub. L. 101–597, § 103(a), substituted ‘‘has been’’ and ‘‘any Corps’’ for ‘‘will be’’ and
‘‘Corps’’, respectively.
Subsec. (b). Pub. L. 101–597, § 103(b), redesignated subsec. (d) as (b) and struck out former subsec. (b) which
related to approval of application for assignment of
Corps personnel subject to review and comment on application by health service agencies in designated area.
Subsec. (c). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Pub. L. 101–597, § 103(b), redesignated subsec. (e) as (c)
and struck out former subsec. (c) which related to applications, consideration and approval by Secretary,
priorities, cooperation with Corps members, and comments by health professionals and societies in designated areas.
Subsec. (d). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area wherever appearing in pars. (1) to (4)(A)(i).

Page 299

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 101–597, § 103(b)(2), redesignated subsec. (g) as
(d). Former subsec. (d) redesignated (b).
Subsec. (e). Pub. L. 101–597, § 103(b)(2), redesignated
subsec. (i) as (e). Former subsec. (e) redesignated (c).
Subsec. (f). Pub. L. 101–597, § 103(b)(1), struck out subsec. (f) which provided for selection of Corps members
for assignment upon basis of characteristics.
Subsec. (g). Pub. L. 101–597, § 103(b)(2), redesignated
subsec. (g) as (d).
Subsec. (h). Pub. L. 101–597, § 103(b)(1), struck out subsec. (h) which related to study and contracts for study
of methods of assignments of Corps members.
Subsec. (i). Pub. L. 101–597, § 103(b)(2), redesignated
subsec. (i) as (e).
Subsecs. (j), (k). Pub. L. 101–597, § 103(b)(1), struck out
subsecs. (j) and (k) which provided for placement of
physicians in medically underserved areas and assignment of family physicians, respectively.
1988—Subsec. (i). Pub. L. 100–607 substituted ‘‘osteopathic medicine’’ for ‘‘osteopathy’’.
1987—Subsec. (j). Pub. L. 100–177, § 303, added subsec.
(j).
Subsec. (k). Pub. L. 100–177, § 304, added subsec. (k).
1981—Subsec. (a). Pub. L. 97–35, § 2703(a), (b), amended
par. (1)(D) generally and, among changes, made numerous changes in nomenclature, inserted at end of par. (1)
provisions respecting application, and added par. (3).
Subsec. (c). Pub. L. 97–35, § 2703(c), struck out par. (2)
which related to special considerations, and redesignated pars. (3) and (4) as (2) and (3), respectively.
Subsecs. (d) to (f). Pub. L. 97–35, § 2703(d), added subsec. (d) and redesignated former subsecs. (d), (e), and (f)
as (e), (f), and (g), respectively.
Subsec. (g). Pub. L. 97–35, § 2703(d), (e), redesignated
former subsec. (f) as (g) and substituted ‘‘may’’ for
‘‘shall’’ in pars. (1) to (3), inserted provisions respecting
health professions personnel in par. (1), added par. (4),
and struck out requirement respecting demonstrated
interest in pars. (1) and (2). Former subsec. (g) redesignated (h).
Subsec. (h). Pub. L. 97–35, § 2703(d), (f), redesignated
former subsec. (g) as (h) and directed that ‘‘may’’ be
substituted for ‘‘shall’’ which was executed by substituting ‘‘may’’ for ‘‘shall’’ in two places preceding
par. (1). Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 97–35, § 2703(d), (g), redesignated
former subsec. (h) as (i) and inserted reference to other
health profession.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1981 AMENDMENT
Section 2703(d) of Pub. L. 97–35 provided that the
amendment made by that section is effective Oct. 1,
1981.

§ 254f–1. Priorities in assignment of Corps personnel
(a) In general
In approving applications made under section
254f of this title for the assignment of Corps
members, the Secretary shall—
(1) give priority to any such application
that—
(A) is made regarding the provision of primary health services to a health professional shortage area with the greatest such
shortage; and
(B) is made by an entity that—
(i) serves a health professional shortage
area described in subparagraph (A);
(ii) coordinates the delivery of primary
health services with related health and social services;

§ 254f–1

(iii) has a documented record of sound
fiscal management; and
(iv) will experience a negative impact on
its capacity to provide primary health
services if a Corps member is not assigned
to the entity;
(2) with respect to the geographic area in
which the health professional shortage area is
located, take into consideration the willingness of individuals in the geographic area, and
of the appropriate governmental agencies or
health entities in the area, to assist and cooperate with the Corps in providing effective
primary health services; and
(3) take into consideration comments of
medical, osteopathic, dental, or other health
professional societies whose members deliver
services to the health professional shortage
area, or if no such societies exist, comments of
physicians, dentists, or other health professionals delivering services to the area.
(b) Establishment of criteria for determining priorities
(1) In general
The Secretary shall establish criteria specifying the manner in which the Secretary
makes a determination under subsection
(a)(1)(A) of this section of the health professional shortage areas with the greatest such
shortages.
(2) Publication of criteria
The criteria required in paragraph (1) shall
be published in the Federal Register not later
than July 1, 1991. Any revisions made in the
criteria by the Secretary shall be effective
upon publication in the Federal Register.
(c) Notifications regarding priorities
(1) Proposed list
The Secretary shall prepare and publish a
proposed list of health professional shortage
areas and entities that would receive priority
under subsection (a)(1) of this section in the
assignment of Corps members. The list shall
contain the information described in paragraph (2), and the relative scores and relative
priorities of the entities submitting applications under section 254f of this title, in a proposed format. All such entities shall have 30
days after the date of publication of the list to
provide additional data and information in
support of inclusion on the list or in support of
a higher priority determination and the Secretary shall reasonably consider such data and
information in preparing the final list under
paragraph (2).
(2) Preparation of list for applicable period
For the purpose of carrying out paragraph
(3), the Secretary shall prepare and, as appropriate, update a list of health professional
shortage areas and entities that are receiving
priority under subsection (a)(1) of this section
in the assignment of Corps members. Such
list—
(A) shall include a specification, for each
such health professional shortage area, of
the entities for which the Secretary has provided an authorization to receive assign-

§ 254f–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ments of Corps members in the event that
Corps members are available for the assignments; and
(B) shall, of the entities for which an authorization described in subparagraph (A)
has been provided, specify—
(i) the entities provided such an authorization for the assignment of Corps members who are participating in the Scholarship Program;
(ii) the entities provided such an authorization for the assignment of Corps members who are participating in the Loan Repayment Program; and
(iii) the entities provided such an authorization for the assignment of Corps
members who have become Corps members
other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs.
The Secretary may set forth such specifications by medical specialty.
(3) Notification of affected parties
(A) Entities
Not later than 30 days after the Secretary
has added to a list under paragraph (2) an entity specified as described in subparagraph
(A) of such paragraph, the Secretary shall
notify such entity that the entity has been
provided an authorization to receive assignments of Corps members in the event that
Corps members are available for the assignments.
(B) Individuals
In the case of an individual obligated to
provide service under the Scholarship Program, not later than 3 months before the
date described in section 254m(b)(5) of this
title, the Secretary shall provide to such individual the names of each of the entities
specified as described in paragraph (2)(B)(i)
that is appropriate for the individual’s medical specialty and discipline.
(4) Revisions
If the Secretary proposes to make a revision
in the list under paragraph (2), and the revision would adversely alter the status of an entity with respect to the list, the Secretary
shall notify the entity of the revision. Any entity adversely affected by such a revision shall
be notified in writing by the Secretary of the
reasons for the revision and shall have 30 days
from such notification to file a written appeal
of the determination involved which shall be
reasonably considered by the Secretary before
the revision to the list becomes final. The revision to the list shall be effective with respect to assignment of Corps members beginning on the date that the revision becomes
final.
(d) Limitation on number of entities offered as
assignment choices in Scholarship Program
(1) Determination of available Corps members
By April 1 of each calendar year, the Secretary shall determine the number of participants in the Scholarship Program who will be
available for assignments under section 254f of

Page 300

this title during the program year beginning
on July 1 of that calendar year.
(2) Determination of number of entities
At all times during a program year, the
number of entities specified under subsection
(c)(2)(B)(i) of this section shall be—
(A) not less than the number of participants determined with respect to that program year under paragraph (1); and
(B) not greater than twice the number of
participants determined with respect to that
program year under paragraph (1).
(July 1, 1944, ch. 373, title III, § 333A, as added
and amended Pub. L. 101–597, title I, § 104, title
IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3015, 3035;
Pub. L. 107–251, title III, § 304, Oct. 26, 2002, 116
Stat. 1646; Pub. L. 108–163, § 2(h), Dec. 6, 2003, 117
Stat. 2022.)
AMENDMENTS
2003—Subsec. (c)(4). Pub. L. 108–163 substituted ‘‘30
days from such notification’’ for ‘‘30 days’’.
2002—Subsec. (a)(1)(A). Pub. L. 107–251, § 304(1), struck
out ‘‘, as determined in accordance with subsection (b)
of this section’’ after ‘‘such shortage’’.
Subsec. (b). Pub. L. 107–251, § 304(2), (7), redesignated
subsec. (c) as (b) and struck out heading and text of
former subsec. (b). Text read as follows: ‘‘In making a
determination under subsection (a)(1)(A) of this section
of the health professional shortage areas with the
greatest such shortages, the Secretary may consider
only the following factors:
‘‘(1) The ratio of available health manpower to the
number of individuals in the area or population group
involved, or served by the medical facility or other
public facility involved.
‘‘(2) Indicators of need as follows:
‘‘(A) The rate of low birthweight births.
‘‘(B) The rate of infant mortality.
‘‘(C) The rate of poverty.
‘‘(D) Access to primary health services, taking
into account the distance to such services.’’
Subsec. (c). Pub. L. 107–251, § 304(7), redesignated subsec. (d) as (c). Former subsec. (c) redesignated (b).
Subsec. (c)(1). Pub. L. 107–251, § 304(3), struck out second sentence, which read as follows: ‘‘Such criteria
shall specify the manner in which the factors described
in subsection (b) of this section are implemented regarding such a determination.’’
Subsec. (d). Pub. L. 107–251, § 304(7), redesignated subsec. (e) as (d). Former subsec. (d) redesignated (c).
Subsec. (d)(1). Pub. L. 107–251, § 304(4)(B), added par.
(1). Former par. (1) redesignated (2).
Subsec. (d)(2). Pub. L. 107–251, § 304(4)(C), in introductory provisions, substituted ‘‘paragraph (3)’’ for ‘‘paragraph (2)’’ and ‘‘prepare and, as appropriate, update a
list of health professional shortage areas and entities’’
for ‘‘prepare a list of health professional shortage
areas’’ and struck out ‘‘for the period applicable under
subsection (f) of this section’’ after ‘‘Corps members’’.
Pub. L. 107–251, § 304(4)(A), redesignated par. (1) as (2).
Former par. (2) redesignated (3).
Subsec. (d)(3). Pub. L. 107–251, § 304(4)(D), added par.
(3) and struck out heading and text of former par. (3).
Text read as follows:
‘‘(A) Not later than 30 days after the preparation of
each list under paragraph (1), the Secretary shall notify
entities specified for purposes of subparagraph (A) of
such paragraph of the fact that the entities have been
provided an authorization to receive assignments of
Corps members in the event that Corps members are
available for the assignments.
‘‘(B) In the case of individuals with respect to whom
a period of obligated service under the Scholarship Program will begin during the period under subsection (f)
of this section for which a list under paragraph (1) is

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

prepared, the Secretary shall, not later than 30 days
after the preparation of each such list, provide to such
individuals the names of each of the entities specified
for purposes of paragraph (1)(B)(i) that is appropriate to
the medical specialty of the individuals.’’
Pub. L. 107–251, § 304(4)(A), redesignated par. (2) as (3).
Former par. (3) redesignated (4).
Subsec. (d)(4). Pub. L. 107–251, § 304(4)(E), added par.
(4) and struck out heading and text of former par. (4).
Text read as follows: ‘‘If the Secretary makes a revision in a list under paragraph (1) during the period
under subsection (f) of this section to which the list is
applicable, and the revision alters the status of an entity with respect to the list, the Secretary shall notify
the entity of the effect on the entity of the revision.
Such notification shall be provided not later than 30
days after the date on which the revision is made.’’
Pub. L. 107–251, § 304(4)(A), redesignated par. (3) as (4).
Subsec. (e). Pub. L. 107–251, § 304(7), redesignated subsec. (e) as (d).
Pub. L. 107–251, § 304(5), added subsec. (e) and struck
out heading and text of former subsec. (e). Text related
to limitation on the number of entities offered as assignment choices in the Scholarship Program based on
the number of participants available for assignments.
Subsec. (f). Pub. L. 107–251, § 304(6), struck out heading
and text of subsec. (f), which related to applicable period regarding priorities in assignment of Corps members.
1990—Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area for reference to health manpower shortage area wherever appearing in subsecs. (a) to (c)(1), (d)(1), and (e)(3).
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 254g. Charges for services by entities using
Corps members
(a) Availability of services regardless of ability to
pay or payment source
An entity to which a Corps member is assigned
shall not deny requested health care services,
and shall not discriminate in the provision of
services to an individual—
(1) because the individual is unable to pay
for the services; or
(2) because payment for the services would
be made under—
(A) the medicare program under title
XVIII of the Social Security Act (42 U.S.C.
1395 et seq.);
(B) the medicaid program under title XIX
of such Act (42 U.S.C. 1396 et seq.); or
(C) the State children’s health insurance
program under title XXI of such Act (42
U.S.C. 1397aa et seq.).
(b) Charges for services
The following rules shall apply to charges for
health care services provided by an entity to
which a Corps member is assigned:
(1) In general
(A) Schedule of fees or payments
Except as provided in paragraph (2), the
entity shall prepare a schedule of fees or
payments for the entity’s services, consistent with locally prevailing rates or charges
and designed to cover the entity’s reasonable cost of operation.
(B) Schedule of discounts
Except as provided in paragraph (2), the
entity shall prepare a corresponding sched-

§ 254g

ule of discounts (including, in appropriate
cases, waivers) to be applied to the payment
of such fees or payments. In preparing the
schedule, the entity shall adjust the discounts on the basis of a patient’s ability to
pay.
(C) Use of schedules
The entity shall make every reasonable effort to secure from patients fees and payments for services in accordance with such
schedules, and fees or payments shall be sufficiently discounted in accordance with the
schedule described in subparagraph (B).
(2) Services to beneficiaries of Federal and federally assisted programs
In the case of health care services furnished
to an individual who is a beneficiary of a program listed in subsection (a)(2) of this section,
the entity—
(A) shall accept an assignment pursuant to
section 1842(b)(3)(B)(ii) of the Social Security Act (42 U.S.C. 1395u(b)(3)(B)(ii)) with respect to an individual who is a beneficiary
under the medicare program; and
(B) shall enter into an appropriate agreement with—
(i) the State agency administering the
program under title XIX of such Act [42
U.S.C. 1396 et seq.] with respect to an individual who is a beneficiary under the medicaid program; and
(ii) the State agency administering the
program under title XXI of such Act [42
U.S.C. 1397aa et seq.] with respect to an individual who is a beneficiary under the
State children’s health insurance program.
(3) Collection of payments
The entity shall take reasonable and appropriate steps to collect all payments due for
health care services provided by the entity, including payments from any third party (including a Federal, State, or local government
agency and any other third party) that is responsible for part or all of the charge for such
services.
(July 1, 1944, ch. 373, title III, § 334, as added Pub.
L. 107–251, title III, § 305, Oct. 26, 2002, 116 Stat.
1647; amended Pub. L. 108–163, § 2(i), Dec. 6, 2003,
117 Stat. 2022.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (a)(2)
and (b)(2)(B), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles XVIII, XIX, and XXI of the Act are
classified generally to subchapters XVIII (§ 1395 et seq.),
XIX (§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.
PRIOR PROVISIONS
A prior section 254g, act July 1, 1944, ch. 373, title III,
§ 334, as added Pub. L. 94–484, title IV, § 407(b)(3), Oct. 12,
1976, 90 Stat. 2274; amended Pub. L. 97–35, title XXVII,
§ 2704, Aug. 13, 1981, 95 Stat. 906; Pub. L. 98–194, § 3, Dec.
1, 1983, 97 Stat. 1345; Pub. L. 100–177, title II, § 202(c),
Dec. 1, 1987, 101 Stat. 996; Pub. L. 101–597, title I, § 105,
title IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3018, 3035,
related to shared responsibility for costs of Corps personnel providing health services in or to a health pro-

§ 254h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fessional shortage area during the assignment period,
prior to repeal by Pub. L. 107–251, title III, § 305, Oct. 26,
2002, 116 Stat. 1647.
AMENDMENTS
2003—Subsec. (b)(1)(B). Pub. L. 108–163 inserted ‘‘the
payment of’’ after ‘‘applied to’’.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 254h. Provision of health services by Corps
members
(a) Means of delivery of services; cooperation
with other health care providers
In providing health services in a health professional shortage area, Corps members shall utilize the techniques, facilities, and organizational forms most appropriate for the area, population group, medical facility, or other public
facility, and shall, to the maximum extent feasible, provide such services (1) to all individuals
in, or served by, such health professional shortage area regardless of their ability to pay for
the services, and (2) in a manner which is cooperative with other health care providers serving
such health professional shortage area.
(b) Utilization of existing health facilities; lease,
acquisition, and use of equipment and supplies; permanent and temporary professional
services
(1) Notwithstanding any other provision of
law, the Secretary may (A) to the maximum extent feasible make such arrangements as he determines necessary to enable Corps members to
utilize the health facilities in or serving the
health professional shortage area in providing
health services; (B) make such arrangements as
he determines are necessary for the use of equipment and supplies of the Service and for the
lease or acquisition of other equipment and supplies; and (C) secure the permanent or temporary services of physicians, dentists, nurses,
administrators, and other health personnel. If
there are no health facilities in or serving such
area, the Secretary may arrange to have Corps
members provide health services in the nearest
health facilities of the Service or may lease or
otherwise provide facilities in or serving such
area for the provision of health services.
(2) If the individuals in or served by a health
professional shortage area are being served (as
determined under regulations of the Secretary)
by a hospital or other health care delivery facility of the Service, the Secretary may, in addition to such other arrangements as he may
make under paragraph (1), arrange for the utilization of such hospital or facility by Corps
members in providing health services, but only
to the extent that such utilization will not impair the delivery of health services and treatment through such hospital or facility to individuals who are entitled to health services and
treatment through such hospital or facility.
(c) Loan; purposes; limitations
The Secretary may make one loan to any entity with an approved application under section

Page 302

254f of this title to assist such entity in meeting
the costs of (1) establishing medical, dental, or
other health profession practices, including the
development of medical practice management
systems; (2) acquiring equipment for use in providing health services; and (3) renovating buildings to establish health facilities. No loan may
be made under this subsection unless an application therefor is submitted to, and approved by,
the Secretary. The amount of any such loan
shall be determined by the Secretary, except
that no such loan may exceed $50,000.
(d) Property and equipment disposal; fair market
value; sale at less than full market value
Upon the expiration of the assignment of all
Corps members to a health professional shortage
area, the Secretary may (notwithstanding any
other provision of law) sell, to any appropriate
local entity, equipment and other property of
the United States utilized by such members in
providing health services. Sales made under this
subsection shall be made at the fair market
value (as determined by the Secretary) of the
equipment or such other property; except that
the Secretary may make such sales for a lesser
value to an appropriate local entity, if he determines that the entity is financially unable to
pay the full market value.
(e) Admitting privileges denied to Corps member
by hospital; notice and hearing; denial of
Federal funds for violation; ‘‘hospital’’ defined
(1)(A) It shall be unlawful for any hospital to
deny an authorized Corps member admitting
privileges when such Corps member otherwise
meets the professional qualifications established
by the hospital for granting such privileges and
agrees to abide by the published bylaws of the
hospital and the published bylaws, rules, and
regulations of its medical staff.
(B) Any hospital which is found by the Secretary, after notice and an opportunity for a
hearing on the record, to have violated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to be eligible to receive any Federal
funds under this chapter or under titles XVIII,
XIX, or XXI of the Social Security Act [42 U.S.C.
1395 et seq., 1396 et seq., 1397aa et seq.].
(2) For purposes of this subsection, the term
‘‘hospital’’ includes a State or local public hospital, a private profit hospital, a private nonprofit hospital, a general or special hospital, and
any other type of hospital (excluding a hospital
owned or operated by an agency of the Federal
Government), and any related facilities.
(July 1, 1944, ch. 373, title III, § 335, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2275; amended Pub. L. 97–35, title XXVII,
§ 2705, Aug. 13, 1981, 95 Stat. 907; Pub. L. 101–597,
title I, § 106, title IV, § 401(b)[(a)], Nov. 16, 1990,
104 Stat. 3018, 3035; Pub. L. 107–251, title III, § 306,
Oct. 26, 2002, 116 Stat. 1648.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(e)(1)(B), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles
XVIII, XIX, and XXI of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
AMENDMENTS
2002—Subsec. (e)(1)(B). Pub. L. 107–251 substituted
‘‘titles XVIII, XIX, or XXI of the Social Security Act’’
for ‘‘titles XVIII or XIX of the Social Security Act’’.
1990—Subsecs. (a), (b)(1)(A), (2), (d). Pub. L. 101–597,
§ 401(b)[(a)], substituted reference to health professional
shortage area for reference to health manpower shortage area wherever appearing.
Subsec. (e)(1)(A). Pub. L. 101–597, § 106, substituted
‘‘authorized Corps member admitting privileges’’ for
‘‘authorized physician or dentist member of the Corps
admitting privileges’’.
1981—Subsec. (a)(2). Pub. L. 97–35, § 2705(a), substituted provisions respecting cooperation with other
health care providers, for provisions respecting direct
health services programs.
Subsec. (c)(4). Pub. L. 97–35, § 2705(b), struck out cl. (4)
relating to appropriate continuing education programs.

§ 254h–1. Facilitation of effective provision of
Corps services
(a) Consideration of individual characteristics of
members in making assignments
In making an assignment of a Corps member
to an entity that has had an application approved under section 254f of this title, the Secretary shall, subject to making the assignment
in accordance with section 254f–1 of this title,
seek to assign to the entity a Corps member who
has (and whose spouse, if any, has) characteristics that increase the probability that the member will remain in the health professional shortage area involved after the completion of the period of service in the Corps.
(b) Counseling on service in Corps
(1) In general
The Secretary shall, subject to paragraph
(3), offer appropriate counseling on service in
the Corps to individuals during the period of
membership in the Corps, particularly during
the initial period of each assignment.
(2) Career advisor regarding obligated service
(A) In the case of individuals who have entered into contracts for obligated service
under the Scholarship or Loan Repayment
Program, counseling under paragraph (1) shall
include appropriate counseling on matters
particular to such obligated service. The Secretary shall ensure that career advisors for
providing such counseling are available to
such individuals throughout the period of participation in the Scholarship or Loan Repayment Program.
(B) With respect to the Scholarship Program, counseling under paragraph (1) shall include counseling individuals during the period
in which the individuals are pursuing an educational degree in the health profession involved, including counseling to prepare the individual for service in the Corps.
(3) Extent of counseling services
With respect to individuals who have entered into contracts for obligated service
under the Scholarship or Loan Repayment
Program, this subsection shall be carried out
regarding such individuals throughout the period of obligated service (and, additionally,

§ 254h–1

throughout the period specified in paragraph
(2)(B), in the case of the Scholarship Program). With respect to Corps members generally, this subsection shall be carried out to the
extent practicable.
(c) Grants regarding preparation of students for
practice
With respect to individuals who have entered
into contracts for obligated service under the
Scholarship or Loan Repayment Program, the
Secretary may make grants to, and enter into
contracts with, public and nonprofit private entities (including health professions schools) for
the conduct of programs designed to prepare
such individuals for the effective provision of
primary health services in the health professional shortage areas to which the individuals
are assigned.
(d) Professional development and training
(1) In general
The Secretary shall assist Corps members in
establishing and maintaining professional relationships and development opportunities, including by—
(A) establishing appropriate professional
relationships between the Corps member involved and the health professions community of the geographic area with respect to
which the member is assigned;
(B) establishing professional development,
training, and mentorship linkages between
the Corps member involved and the larger
health professions community, including
through
distance
learning,
direct
mentorship, and development and implementation of training modules designed to meet
the educational needs of offsite Corps members;
(C) establishing professional networks
among Corps members; or
(D) engaging in other professional development, mentorship, and training activities
for Corps members, at the discretion of the
Secretary.
(2) Assistance in establishing professional relationships
In providing such assistance under paragraph (1), the Secretary shall focus on establishing relationships with hospitals, with academic medical centers and health professions
schools, with area health education centers
under section 294a of this title, with health
education and training centers under section
294b 1 of this title, and with border health education and training centers under such section
294b 1 of this title. Such assistance shall include assistance in obtaining faculty appointments at health professions schools.
(3) Supplement not supplant
Such efforts under this subsection shall supplement, not supplant, non-government efforts
by professional health provider societies to establish and maintain professional relationships and development opportunities.
1 See

References in Text note below.

§ 254h–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Temporary relief from Corps duties
(1) In general
The Secretary shall, subject to paragraph
(4), provide assistance to Corps members in establishing arrangements through which Corps
members may, as appropriate, be provided
temporary relief from duties in the Corps in
order to pursue continuing education in the
health professions, to participate in exchange
programs with teaching centers, to attend professional conferences, or to pursue other interests, including vacations.
(2) Assumption of duties of member
(A) Temporary relief under paragraph (1)
may be provided only if the duties of the Corps
member involved are assumed by another
health professional. With respect to such temporary relief, the duties may be assumed by
Corps members or by health professionals who
are not Corps members, if the Secretary approves the professionals for such purpose. Any
health professional so approved by the Secretary shall, during the period of providing
such temporary relief, be deemed to be a Corps
member for purposes of section 233 of this title
(including for purposes of the remedy described in such section), section 254f(f) of this
title, and section 254h(e) of this title.
(B) In carrying out paragraph (1), the Secretary shall provide for the formation and continued existence of a group of health professionals to provide temporary relief under such
paragraph.
(3) Recruitment from general health professions community
In carrying out paragraph (1), the Secretary
shall—
(A) encourage health professionals who are
not Corps members to enter into arrangements under which the health professionals
temporarily assume the duties of Corps
members for purposes of paragraph (1); and
(B) with respect to the entities to which
Corps members have been assigned under
section 254f of this title, encourage the entities to facilitate the development of arrangements described in subparagraph (A).
(4) Limitation
In carrying out paragraph (1), the Secretary
may not, except as provided in paragraph (5),
obligate any amounts (other than for incidental expenses) for the purpose of—
(A) compensating a health professional
who is not a Corps member for assuming the
duties of a Corps member; or
(B) paying the costs of a vacation, or other
interests that a Corps member may pursue
during the period of temporary relief under
such paragraph.
(5) Sole providers of health services
In the case of any Corps member who is the
sole provider of health services in the geographic area involved, the Secretary may,
from amounts appropriated under section 254k
of this title, obligate on behalf of the member
such sums as the Secretary determines to be
necessary for purposes of providing temporary
relief under paragraph (1).

Page 304

(f) Determinations regarding effective service
In carrying out subsection (a) of this section
and sections 254l(d) and 254l–1(d) of this title, the
Secretary shall carry out activities to determine—
(1) the characteristics of physicians, dentists, and other health professionals who are
more likely to remain in practice in health
professional shortage areas after the completion of the period of service in the Corps;
(2) the characteristics of health manpower
shortage areas, and of entities seeking assignments of Corps members, that are more likely
to retain Corps members after the members
have completed the period of service in the
Corps; and
(3) the appropriate conditions for the assignment and utilization in health manpower
shortage areas of certified nurse practitioners,
certified nurse midwives, and physician assistants.
(July 1, 1944, ch. 373, title III, § 336, as added Pub.
L. 97–35, title XXVII, § 2706(b), Aug. 13, 1981, 95
Stat. 907; amended Pub. L. 100–177, title II,
§ 202(d), Dec. 1, 1987, 101 Stat. 997; Pub. L. 101–597,
title I, § 107, title IV, § 401(b)[(a)], Nov. 16, 1990,
104 Stat. 3018, 3035; Pub. L. 107–251, title III,
§ 307(a), Oct. 26, 2002, 116 Stat. 1649; Pub. L.
110–355, § 3(d), Oct. 8, 2008, 122 Stat. 3993.)
REFERENCES IN TEXT
Section 294b of this title, referred to in subsec. (d)(2),
was repealed and a new section 294b enacted by Pub. L.
111–148, title V, § 5403(b), Mar. 23, 2010, 124 Stat. 648, and,
as so enacted, no longer relates to health education and
training centers.
PRIOR PROVISIONS
A prior section 336 of act July 1, 1944, was renumbered
section 336A by Pub. L. 97–35, § 2706(a), and is classified
to section 254i of this title.
AMENDMENTS
2008—Subsec. (d). Pub. L. 110–355 amended subsec. (d)
generally. Prior to amendment, text read as follows:
‘‘The Secretary shall assist Corps members in establishing appropriate professional relationships between
the Corps member involved and the health professions
community of the geographic area with respect to
which the member is assigned, including such relationships with hospitals, with health professions schools,
with area health education centers under section 295g–1
of this title, with health education and training centers
under such section, and with border health education
and training centers under such section. Such assistance shall include assistance in obtaining faculty appointments at health professions schools.’’
2002—Subsecs. (c), (f)(1). Pub. L. 107–251 substituted
‘‘health professional shortage areas’’ for ‘‘health manpower shortage areas’’.
1990—Pub. L. 101–597, § 107, amended section generally.
Prior to amendment, section read as follows:
‘‘(a) The Secretary may make grants to and enter
into contracts with public and private nonprofit entities for the conduct of programs which are designed to
prepare individuals subject to a service obligation
under the National Health Service Corps Scholarship
Program or Loan Repayment Program to effectively
provide health services in the health manpower shortage area to which they are assigned.
‘‘(b) No grant may be made or contract entered into
under subsection (a) of this section unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information,
as the Secretary shall by regulation prescribe.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a). Pub. L. 101–597, § 401(b)[(a)], substituted
‘‘health professional shortage area’’ for ‘‘health manpower shortage area’’.
1987—Subsec. (a). Pub. L. 100–177 substituted ‘‘Scholarship Program or Loan Repayment Program’’ for
‘‘scholarship program’’.

§ 254i. Annual report to Congress; contents
The Secretary shall submit an annual report
to Congress, and shall include in such report
with respect to the previous calendar year—
(1) the number, identity, and priority of all
health professional shortage areas designated
in such year and the number of health professional shortage areas which the Secretary estimates will be designated in the subsequent
year;
(2) the number of applications filed under
section 254f of this title in such year for assignment of Corps members and the action
taken on each such application;
(3) the number and types of Corps members
assigned in such year to health professional
shortage areas, the number and types of additional Corps members which the Secretary estimates will be assigned to such areas in the
subsequent year, and the need for additional
members for the Corps;
(4) the recruitment efforts engaged in for the
Corps in such year and the number of qualified
individuals who applied for service in the
Corps in such year;
(5) the number of patients seen and the number of patient visits recorded during such year
with respect to each health professional shortage area to which a Corps member was assigned during such year;
(6) the number of Corps members who elected, and the number of Corps members who did
not elect, to continue to provide health services in health professional shortage areas after
termination of their service in the Corps and
the reasons (as reported to the Secretary) of
members who did not elect for not making
such election;
(7) the results of evaluations and determinations made under section 254f(a)(1)(D) of this
title during such year; and
(8) the amount charged during such year for
health services provided by Corps members,
the amount which was collected in such year
by entities in accordance with section 254g of
this title, and the amount which was paid to
the Secretary in such year under such agreements.
(July 1, 1944, ch. 373, title III, § 336A, formerly
§ 336, as added Pub. L. 94–484, title IV, § 407(b)(3),
Oct. 12, 1976, 90 Stat. 2277, renumbered § 336A,
Pub. L. 97–35, title XXVII, § 2706(a), Aug. 13, 1981,
95 Stat. 907; amended Pub. L. 97–375, title II,
§ 206(a), Dec. 21, 1982, 96 Stat. 1823; Pub. L.
101–597, title IV, § 401(b)[(a)], Nov. 16, 1990, 104
Stat. 3035; Pub. L. 107–251, title III, § 307(b), Oct.
26, 2002, 116 Stat. 1649.)
AMENDMENTS
2002—Par. (8). Pub. L. 107–251 struck out ‘‘agreements
under’’ after ‘‘in accordance with’’.
1990—Pars. (1), (3), (5), (6). Pub. L. 101–597 substituted
reference to health professional shortage area for reference to health manpower shortage area wherever appearing.

§ 254j

1982—Pub. L. 97–375 struck out ‘‘on May 1 of each
year’’ after ‘‘report to Congress’’.

§ 254j. National Advisory Council on National
Health Service Corps
(a) Establishment; appointment of members
There is established a council to be known as
the National Advisory Council on the National
Health Service Corps (hereinafter in this section
referred to as the ‘‘Council’’). The Council shall
be composed of not more than 15 members appointed by the Secretary. The Council shall consult with, advise, and make recommendations
to, the Secretary with respect to his responsibilities in carrying out this subpart (other than
section 254r 1 of this title), and shall review and
comment upon regulations promulgated by the
Secretary under this subpart.
(b) Term of members; compensation; expenses
(1) Members of the Council shall be appointed
for a term of three years, except that any member appointed to fill a vacancy occurring prior
to the expiration of the term for which the
member’s predecessor was appointed shall be appointed for the remainder of such term. No
member shall be removed, except for cause.
(2) Members of the Council (other than members who are officers or employees of the United
States), while attending meetings or conferences
thereof or otherwise serving on the business of
the Council, shall be entitled to receive for each
day (including traveltime) in which they are so
serving compensation at a rate fixed by the Secretary (but not to exceed the daily equivalent of
the annual rate of basic pay in effect for grade
GS–18 of the General Schedule); and while so
serving away from their homes or regular places
of business all members may be allowed travel
expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for
persons in the Government Service employed
intermittently.
(c) Termination
Section 14 of the Federal Advisory Committee
Act shall not apply with respect to the Council.
(July 1, 1944, ch. 373, title III, § 337, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2277; amended Pub. L. 96–32, § 7(g), July 10,
1979, 93 Stat. 84; Pub. L. 97–35, title XXVII, § 2707,
Aug. 13, 1981, 95 Stat. 907; Pub. L. 97–414, § 8(f),
Jan. 4, 1983, 96 Stat. 2061; Pub. L. 103–183, title
VII, § 706(b), Dec. 14, 1993, 107 Stat. 2241; Pub. L.
111–148, title X, § 10501(n)(3), Mar. 23, 2010, 124
Stat. 1003.)
REFERENCES IN TEXT
Section 254r of this title, referred to in subsec. (a),
was in the original a reference to section 338G of act
July 1, 1944, which was renumbered section 338I by Pub.
L. 100–177, title II, § 201(1), Dec. 1, 1987, 101 Stat. 992, and
repealed by Pub. L. 100–713, title I, § 104(b)(1), Nov. 23,
1988, 102 Stat. 4787.
Section 14 of the Federal Advisory Committee Act,
referred to in subsec. (c), is section 14 of Pub. L. 92–463,
which is set out in the Appendix to Title 5, Government
Organization and Employees.
AMENDMENTS
2010—Subsec. (b)(1). Pub. L. 111–148 struck out at end
‘‘Members may not be reappointed to the Council.’’
1 See

References in Text note below.

§ 254k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1993—Subsec. (b)(2). Pub. L. 103–183 inserted ‘‘compensation at a rate fixed by the Secretary (but not to
exceed’’ before ‘‘the daily equivalent’’ and substituted
‘‘Schedule);’’ for ‘‘Schedule;’’.
1983—Subsec. (a). Pub. L. 97–414 inserted ‘‘(other than
section 254r of this title)’’ after ‘‘carrying out this subpart’’.
1981—Subsec. (a). Pub. L. 97–35, § 2707(a), amended subsec. (a) generally, striking out pars. (1) to (5) respecting
required status and background of members appointed
by the Secretary.
Subsec. (b)(1). Pub. L. 97–35, § 2707(b), inserted ‘‘not’’
before ‘‘be reappointed’’.
1979—Subsec. (b)(2). Pub. L. 96–32 substituted ‘‘section
5703 of title 5’’ for ‘‘section 5703(b) of title 5’’.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 254k. Authorization of appropriations
(a) For the purpose of carrying out this subpart, there are authorized to be appropriated
such sums as may be necessary for each of the
fiscal years 2008 through 2012.
(b) An appropriation under an authorization
under subsection (a) of this section for any fiscal
year may be made at any time before that fiscal
year and may be included in an Act making an
appropriation under an authorization under subsection (a) of this section for another fiscal
year; but no funds may be made available from
any appropriation under such authorization for
obligation under sections 254d through 254h, section 254i, and section 254j of this title before the
fiscal year for which such appropriation is authorized.
(July 1, 1944, ch. 373, title III, § 338, as added Pub.
L. 94–484, title IV, § 407(b)(3), Oct. 12, 1976, 90
Stat. 2278; amended Pub. L. 95–626, title I, § 122,
Nov. 10, 1978, 92 Stat. 3570; Pub. L. 96–76, title II,
§ 202(c), Sept. 29, 1979, 93 Stat. 582; Pub. L. 97–35,
title XXVII, § 2708, Aug. 13, 1981, 95 Stat. 908;
Pub. L. 100–177, title III, § 305, Dec. 1, 1987, 101
Stat. 1004; Pub. L. 101–597, title I, § 108, Nov. 16,
1990, 104 Stat. 3021; Pub. L. 107–251, title III, § 308,
Oct. 26, 2002, 116 Stat. 1649; Pub. L. 110–355,
§ 3(a)(1), Oct. 8, 2008, 122 Stat. 3993.)
AMENDMENTS
2008—Subsec. (a). Pub. L. 110–355 substituted ‘‘2008
through 2012’’ for ‘‘2002 through 2006’’.
2002—Subsec. (a). Pub. L. 107–251 struck out par. (1)
designation before ‘‘For the purpose’’, substituted ‘‘2002
through 2006’’ for ‘‘1991 through 2000’’, and struck out
par. (2) which read as follows: ‘‘In the case of individuals who serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program, the Secretary each fiscal year shall, to
the extent practicable, make assignments under section 254f of this title of such individuals who are cer-

Page 306

tified nurse midwives, certified nurse practitioners, or
physician assistants.’’
1990—Subsec. (a). Pub. L. 101–597 added subsec. (a) and
struck out former subsec. (a) which read as follows:
‘‘To carry out this subpart, there are authorized to be
appropriated $65,000,000 for fiscal year 1988, $65,000,000
for fiscal year 1989, and $65,000,000 for fiscal year 1990.’’
1987—Subsec. (a). Pub. L. 100–177 amended subsec. (a)
generally. Prior to amendment, subsec. (a) read as follows: ‘‘To carry out the purposes of this subpart, there
are authorized to be appropriated $47,000,000 for the fiscal year ending September 30, 1978; $64,000,000 for the
fiscal year ending September 30, 1979; $82,000,000 for the
fiscal year ending September 30, 1980; $110,000,000 for
the fiscal year ending September 30, 1982; $120,000,000
for the fiscal year ending September 30, 1983; and
$130,000,000 for the fiscal year ending September 30,
1984.’’
1981—Subsec. (a). Pub. L. 97–35, § 2708(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and 1984.
Subsec. (b). Pub. L. 97–35, § 2708(b), substituted reference to sections 254d to 254h, 254i, and 254j of this
title for reference to this subpart.
1979—Subsec.
(a).
Pub.
L.
96–76
substituted
‘‘$82,000,000’’ for ‘‘$70,000,000’’.
1978—Subsec. (a). Pub. L. 95–626 substituted
‘‘$64,000,000’’ for ‘‘$57,000,000’’ as amount authorized to
be appropriated for fiscal year ending Sept. 30, 1979.
SUBPART III—SCHOLARSHIP PROGRAM AND LOAN
REPAYMENT PROGRAM

AMENDMENTS
1987—Pub. L. 100–177, title II, § 202(f), Dec. 1, 1987, 101
Stat. 999, inserted subpart III heading and redesignated
former subpart III as IV.

§ 254l. National Health Service Corps Scholarship Program
(a) Establishment
The Secretary shall establish the National
Health Service Corps Scholarship Program to
assure, with respect to the provision of primary
health services pursuant to section 254d(a)(2) of
this title—
(1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse midwives, certified
nurse practitioners, and physician assistants;
and
(2) if needed by the Corps, an adequate supply of other health professionals.
(b) Eligibility; application; written contract
To be eligible to participate in the Scholarship
Program, an individual must—
(1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by the Secretary) educational institution in a State and (B) in a
course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession, or
an appropriate degree from a graduate program of behavioral and mental health;
(2) be eligible for, or hold, an appointment as
a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps;
(3) submit an application to participate in
the Scholarship Program; and
(4) sign and submit to the Secretary, at the
time of submittal of such application, a writ-

Page 307

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ten contract (described in subsection (f) of this
section) to accept payment of a scholarship
and to serve (in accordance with this subpart)
for the applicable period of obligated service
in a health professional shortage area.
(c) Review and evaluation of information and
forms by prospective applicant
(1) In disseminating application forms and
contract forms to individuals desiring to participate in the Scholarship Program, the Secretary
shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the
Secretary, including in the summary a clear
explanation of the damages to which the
United States is entitled under section 254o of
this title in the case of the individual’s breach
of the contract; and
(B) information respecting meeting a service
obligation through private practice under an
agreement under section 254n of this title and
such other information as may be necessary
for the individual to understand the individual’s prospective participation in the Scholarship Program and service in the Corps, including a statement of all factors considered in approving applications for participation in the
Program and in making assignments for participants in the Program.
(2) The application form, contract form, and
all other information furnished by the Secretary
under this subpart shall be written in a manner
calculated to be understood by the average individual applying to participate in the Scholarship Program. The Secretary shall make such
application forms, contract forms, and other information available to individuals desiring to
participate in the Scholarship Program on a
date sufficiently early to insure that such individuals have adequate time to carefully review
and evaluate such forms and information.
(3)(A) The Secretary shall distribute to health
professions schools materials providing information on the Scholarship Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional
whose period of obligated service under the
Scholarship Program is nearing completion, the
Secretary shall encourage the individual to remain in a health professional shortage area and
to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to
private practice from obligated service under
the Scholarship Program, the Secretary may
provide assistance to the professional regarding
such transition if the professional is remaining
in a health professional shortage area and is
continuing to provide primary health services.
(C) In the case of entities to which participants in the Scholarship Program are assigned
under section 254f of this title, the Secretary
shall encourage the entities to provide options
with respect to assisting the participants in remaining in the health professional shortage
areas involved, and in continuing to provide primary health services, after the period of obligated service under the Scholarship Program is

§ 254l

completed. The options with respect to which
the Secretary provides such encouragement may
include options regarding the sharing of a single
employment position in the health professions
by 2 or more health professionals, and options
regarding the recruitment of couples where both
of the individuals are health professionals.
(d) Factors considered in providing contracts;
priorities
(1) Subject to section 254f–1 of this title, in
providing contracts under the Scholarship Program—
(A) the Secretary shall consider the extent
of the demonstrated interest of the applicants
for the contracts in providing primary health
services;
(B) the Secretary, in considering applications from individuals accepted for enrollment
or enrolled in dental school, shall consider applications from all individuals accepted for enrollment or enrolled in any accredited dental
school in a State; and
(C) may 1 consider such other factors regarding the applicants as the Secretary determines
to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Scholarship Program, the Secretary shall give priority—
(A) first, to any application for such a contract submitted by an individual who has previously received a scholarship under this section or under section 294z 1 of this title;
(B) second, to any application for such a
contract submitted by an individual who has
characteristics that increase the probability
that the individual will continue to serve in a
health professional shortage area after the period of obligated service pursuant to subsection (f) of this section is completed; and
(C) third, subject to subparagraph (B), to any
application for such a contract submitted by
an individual who is from a disadvantaged
background.
(e) Commencement of participation in Scholarship Program; notice
(1) An individual becomes a participant in the
Scholarship Program only upon the Secretary’s
approval of the individual’s application submitted under subsection (b)(3) of this section and
the Secretary’s acceptance of the contract submitted by the individual under subsection (b)(4)
of this section.
(2) The Secretary shall provide written notice
to an individual promptly upon the Secretary’s
approving, under paragraph (1), of the individual’s participation in the Scholarship Program.
(f) Written contract; contents
The written contract (referred to in this subpart) between the Secretary and an individual
shall contain—
(1) an agreement that—
(A) subject to paragraph (2), the Secretary
agrees (i) to provide the individual with a
scholarship (described in subsection (g) of
this section) in each such school year or
1 So

in original.

§ 254l

TITLE 42—THE PUBLIC HEALTH AND WELFARE

years for a period of years (not to exceed
four school years) determined by the individual, during which period the individual is
pursuing a course of study described in subsection (b)(1)(B) of this section, and (ii) to
accept (subject to the availability of appropriated funds for carrying out sections 254d
through 254h and section 254j of this title)
the individual into the Corps (or for equivalent service as otherwise provided in this
subpart); and
(B) subject to paragraph (2), the individual
agrees—
(i) to accept provision of such a scholarship to the individual;
(ii) to maintain enrollment in a course of
study described in subsection (b)(1)(B) of
this section until the individual completes
the course of study;
(iii) while enrolled in such course of
study, to maintain an acceptable level of
academic standing (as determined under
regulations of the Secretary by the educational institution offering such course of
study);
(iv) if pursuing a degree from a school of
medicine or osteopathic medicine, to complete a residency in a specialty that the
Secretary determines is consistent with
the needs of the Corps; and
(v) to serve for a time period (hereinafter
in the subpart referred to as the ‘‘period of
obligated service’’) equal to—
(I) one year for each school year for
which the individual was provided a
scholarship under the Scholarship Program, or
(II) two years,
whichever is greater, as a provider of primary health services in a health professional shortage area (designated under section 254e of this title) to which he is assigned by the Secretary as a member of
the Corps, or as otherwise provided in this
subpart;
(2) a provision that any financial obligation
of the United States arising out of a contract
entered into under this subpart and any obligation of the individual which is conditioned
thereon, is contingent upon funds being appropriated for scholarships under this subpart and
to carry out the purposes of sections 254d
through 254h and sections 254j and 254k of this
title;
(3) a statement of the damages to which the
United States is entitled, under section 254o of
this title, for the individual’s breach of the
contract; and
(4) such other statements of the rights and
liabilities of the Secretary and of the individual, not inconsistent with the provisions of
this subpart.
(g) Scholarship provisions; contract with educational institution; increase in monthly stipend
(1) A scholarship provided to a student for a
school year under a written contract under the
Scholarship Program shall consist of—
(A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the

Page 308

amount (except as provided in section 292k 2 of
this title) of—
(i) the tuition of the student in such school
year; and
(ii) all other reasonable educational expenses, including fees, books, and laboratory
expenses, incurred by the student in such
school year; and
(B) payment to the student of a stipend of
$400 per month (adjusted in accordance with
paragraph (3)) for each of the 12 consecutive
months beginning with the first month of such
school year.
(2) The Secretary may contract with an educational institution, in which a participant in
the Scholarship Program is enrolled, for the
payment to the educational institution of the
amounts of tuition and other reasonable educational expenses described in paragraph (1)(A).
Payment to such an educational institution may
be made without regard to section 3324(a) and (b)
of title 31.
(3) The amount of the monthly stipend, specified in paragraph (1)(B) and as previously adjusted (if at all) in accordance with this paragraph, shall be increased by the Secretary for
each school year ending in a fiscal year beginning after September 30, 1978, by an amount
(rounded to the next highest multiple of $1)
equal to the amount of such stipend multiplied
by the overall percentage (under section 5303 of
title 5) of the adjustment (if such adjustment is
an increase) in the rates of pay under the General Schedule made effective in the fiscal year
in which such school year ends.
(h) Employment ceiling of Department unaffected
Notwithstanding any other provision of law,
individuals who have entered into written contracts with the Secretary under this section,
while undergoing academic training, shall not
be counted against any employment ceiling affecting the Department.
(July 1, 1944, ch. 373, title III, § 338A, formerly
title VII, § 751, as added Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2281; amended
Pub. L. 95–215, § 5, Dec. 19, 1977, 91 Stat. 1506;
Pub. L. 95–623, § 12(c), Nov. 9, 1978, 92 Stat. 3457;
Pub. L. 95–626, title I, § 113(b), Nov. 10, 1978, 92
Stat. 3563; Pub. L. 96–32, § 7(i), July 10, 1979, 93
Stat. 84; renumbered § 338A and amended Pub. L.
97–35, title XXVII, § 2709(a), (b), Aug. 13, 1981, 95
Stat. 908; Pub. L. 99–129, title II, § 210(b), Oct. 22,
1985, 99 Stat. 537; Pub. L. 100–607, title VI,
§ 629(a)(2), Nov. 4, 1988, 102 Stat. 3146; Pub. L.
101–509, title V, § 529 [title I, § 101(b)(4)(K)], Nov.
5, 1990, 104 Stat. 1427, 1440; Pub. L. 101–597, title
II, § 201, title IV, § 401(b)[(a)], Nov. 16, 1990, 104
Stat. 3021, 3035; Pub. L. 107–251, title III, § 309,
Oct. 26, 2002, 116 Stat. 1649; Pub. L. 108–163, § 2(j),
Dec. 6, 2003, 117 Stat. 2022.)
REFERENCES IN TEXT
Section 294z of this title, referred to in subsec.
(d)(2)(A), was omitted in the general revision of subchapter V of this chapter by Pub. L. 102–408, title I,
§ 102, Oct. 13, 1992, 106 Stat. 1994.
2 See

References in Text note below.

Page 309

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 292k of this title, referred to in subsec.
(g)(1)(A), was in the original a reference to section 711
of act July 1, 1944. Section 711 of that Act was renumbered as section 710 by Pub. L. 97–35, title XXVII,
§ 2720(b), Aug. 13, 1981, 95 Stat. 915, and subsequently
omitted in the general revision of subchapter V of this
chapter by Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1994. Pub. L. 102–408 enacted a new section 710 of
act July 1, 1944, relating to insurance accounts, a new
section 711, relating to powers and responsibilities of
the Secretary, and a new section 712, relating to participation by Federal credit unions, which are classified to sections 292i, 292j, and 292k, respectively, of this
title.
CODIFICATION
In subsec. (g)(2), ‘‘section 3324(a) and (b) of title 31’’
substituted for ‘‘section 3648 of the Revised Statutes (31
U.S.C. 529)’’ on authority of Pub. L. 97–258, § 4(b), Sept.
13, 1982, 96 Stat. 1067, the first section of which enacted
Title 31, Money and Finance.
Section was formerly classified to section 294t of this
title prior to its renumbering by Pub. L. 97–35.
AMENDMENTS
2003—Subsec. (d)(1)(B). Pub. L. 108–163 realigned margin.
2002—Subsec. (a)(1). Pub. L. 107–251, § 309(1), inserted
‘‘behavioral and mental health professionals,’’ after
‘‘dentists,’’.
Subsec. (b)(1)(B). Pub. L. 107–251, § 309(2), inserted
‘‘, or an appropriate degree from a graduate program of
behavioral and mental health’’ after ‘‘other health profession’’.
Subsec. (c)(1). Pub. L. 107–251, § 309(3), made technical
amendment to references in original act which appear
in subpar. (A) as reference to section 254o of this title
and in subpar. (B) as reference to section 254n of this
title.
Subsec. (d)(1)(B), (C). Pub. L. 107–251, § 309(4), added
subpar. (B) and redesignated former subpar. (B) as (C).
Subsec. (f)(1)(B)(iv), (v). Pub. L. 107–251, § 309(5)(A),
added cl. (iv) and redesignated former cl. (iv) as (v).
Subsec. (f)(3). Pub. L. 107–251, § 309(5)(B), made technical amendment to reference in original act which appears in text as reference to section 254o of this title.
Subsec. (i). Pub. L. 107–251, § 309(6), struck out subsec.
(i), which required an annual report to Congress on the
Scholarship Program.
1990—Subsec. (a). Pub. L. 101–597, § 201(a)(1), substituted ‘‘Corps Scholarship Program to assure, with
respect to the provision of primary health services pursuant to section 254d(a)(2) of this title—’’ and pars. (1)
and (2) for ‘‘Corps Scholarship Program (hereinafter in
this subpart referred to as the ‘Scholarship Program’)
to assure an adequate supply of trained physicians,
dentists, and nurses for the National Health Service
Corps (hereinafter in this subpart referred to as the
‘Corps’) and, if needed by the Corps, podiatrists, optometrists, pharmacists, clinical psychologists, graduates
of schools of veterinary medicine, graduates of schools
of public health, graduates of programs in health administration, graduates of programs for the training of
physician assistants, expanded function dental auxiliaries, and nurse practitioners (as defined in section
296m of this title), and other health professionals.’’
Subsec. (b)(4). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Subsec. (c). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (3)(B),
(C).
Pub. L. 101–597, § 201(b), inserted par. (1) designation,
redesignated former pars. (1) and (2) as subpars. (A) and
(B), inserted before period at end of subpar. (B)
‘‘, including a statement of all factors considered in approving applications for participation in the Program
and in making assignments for participants in the Program’’, inserted par. (2) designation, and added par. (3).

§ 254l

Subsec. (d). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (2)(B).
Pub. L. 101–597, § 201(c), amended subsec. (d) generally.
Prior to amendment, subsec. (d) read as follows: ‘‘In determining which applications under the Scholarship
Program to approve (and which contracts to accept),
the Secretary shall give priority—
‘‘(1) first, to applications made (and contracts submitted) by individuals who have previously received
scholarships under the Scholarship Program or under
section 294z of this title; and
‘‘(2) second, to applications made (and contracts
submitted)—
‘‘(A) for the school year beginning in calendar
year 1978, by individuals who are entering their
first, second, or third year of study in a course of
study or program described in subsection (b)(1)(B)
of this section in such school year;
‘‘(B) for the school year beginning in calendar
year 1979, by individuals who are entering their
first or second year of study in a course of study or
program described in subsection (b)(1)(B) of this
section in such school year; and
‘‘(C) for each school year thereafter, by individuals who are entering their first year of study in a
course of study or program described in subsection
(b)(1)(B) of this section in such school year.’’
Subsec. (f)(1)(B)(iv). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area in closing provisions.
Pub. L. 101–597, § 201(a)(2), substituted ‘‘as a provider
of primary health services’’ after ‘‘whichever is greater,’’.
Subsec. (g)(3). Pub. L. 101–509 substituted ‘‘(under section 5303 of title 5)’’ for ‘‘(as set forth in the report
transmitted to the Congress under section 5305 of title
5)’’.
Subsec. (i). Pub. L. 101–597, § 201(d)(1), amended introductory provisions generally. Prior to amendment, introductory provisions read as follows: ‘‘The Secretary
shall report to Congress on March 1 of each year—’’.
Subsec. (i)(4), (5). Pub. L. 101–597, § 201(d)(2), added
pars. (4) and (5) and struck out former par. (4) which
read as follows: ‘‘the amount of tuition paid in the aggregate and at each educational institution for the
school year beginning in such year and for prior school
years.’’
Subsec. (i)(6). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area.
Pub. L. 101–597, § 201(d)(2)(C), added par. (6).
1988—Subsec. (b)(1). Pub. L. 100–607 substituted ‘‘osteopathic medicine’’ for ‘‘osteopathy’’.
1985—Subsec. (g)(1). Pub. L. 99–129 struck out ‘‘or
under section 294z of this title (relating to scholarships
for first-year students of exceptional financial need),’’
after ‘‘Scholarship Program’’.
1981—Subsec. (a). Pub. L. 97–35, § 2709(b)(1), inserted
reference to clinical psychologists.
Subsec. (c). Pub. L. 97–35, § 2709(b)(2), (3), substituted
‘‘254o’’ for ‘‘294w’’ in par. (1), and inserted provisions relating to information concerning meeting the service
obligation in par. (2).
Subsec. (f). Pub. L. 97–35, § 2709(b)(4)–(6), in par. (1)
substituted reference to sections 254d to 254h and 254j of
this title, for reference to subpart II of part D of subchapter II of this chapter, in par. (2) substituted reference to sections 254d to 254h, 254j and 254k of this
title, for reference to subpart II of part D of subchapter
II of this chapter, and in par. (3) substituted ‘‘254o’’ for
‘‘294w’’.
Subsec. (j). Pub. L. 97–35, § 2709(b)(7), struck out subsec. (j) which related to consultation and participation
of schools.
1979—Subsec. (g)(3). Pub. L. 96–32 substituted ‘‘section
5305 of title 5’’ for ‘‘section 5303 of title 5’’.
1978—Subsec. (f). Pub. L. 95–626 substituted ‘‘subpart
II of part D’’ for ‘‘subpart II of part C’’ in pars. (1)(A)
and (2).

§ 254l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (i). Pub. L. 95–623 substituted March 1 for December 1 as the date for Secretary’s annual report to
Congress.
1977—Subsec. (d)(2). Pub. L. 95–215 substituted provisions relating to the school years beginning in calendar
years 1978 and 1979 for provisions relating to the school
year ending in the fiscal year beginning Oct. 1, 1977.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–509 effective on such date
as the President shall determine, but not earlier than
90 days, and not later than 180 days, after Nov. 5, 1990,
see section 529 [title III, § 305] of Pub. L. 101–509, set out
as a note under section 5301 of Title 5, Government Organization and Employees.
EFFECTIVE DATE OF 1985 AMENDMENT
Section 228 of Pub. L. 99–129 provided that:
‘‘(a) Except as provided in subsection (b), this Act and
the amendments and repeals made by this Act [enacting sections 294q–1 to 294q–3 of this title, amending this
section and sections 292a, 292b, 292h, 292j, 293c, 294a,
294b, 294d, 294e, 294g, 294j, 294m to 294p, 294z, 295f to
295f–2, 295g, 295g–1, 295g–3, 295g–4, 295g–6 to 295g–8,
295g–8b, 295h, 295h–1a to 295h–1c, 296k, 296l, 296m, 297a,
298b–5, and 300aa–14 of this title, repealing sections
292c, 295 to 295e–5, 295g–2, 295g–5, 295g–8a, and 295g–9 of
this title, enacting provisions set out as notes under
sections 201, 292h, 293c, 294d, 294n, and 300aa–14 of this
title and section 462 of the Appendix to Title 50, War
and National Defense, and amending provisions set out
as a note under section 298b–5 of this title] shall take
effect on the date of enactment of this Act [Oct. 22,
1985].
‘‘(b)(1) The amendments made by section 101(a) of this
Act [amending section 294a of this title] shall take effect as of October 1, 1985.
‘‘(2) The amendments made by section 208(e) of this
Act [amending section 294e of this title] shall take effect nine months after the date of enactment of this
Act [Oct. 22, 1985].
‘‘(3) The amendment made by section 208(h) of this
Act [amending section 294a of this title] shall take effect as of October 1, 1983.
‘‘(4) The provisions of section 746 of the Public Health
Service Act (as added by the amendment made by section 209(h)(2) of this Act) [section 294g–2 of this title]
shall take effect as of June 30, 1984.
‘‘(5) The amendments made by section 209(j) of this
Act [amending sections 294m and 297a of this title]
shall take effect as of June 30, 1984.
‘‘(6) The amendments made by section 213(a) of this
Act [amending section 295g–1 of this title] shall take effect as of October 1, 1985.’’
EFFECTIVE DATE OF 1977 AMENDMENT
Section 5 of Pub. L. 95–215 provided that the amendment made by that section is effective Oct. 1, 1977.
EFFECTIVE DATE
Section 408(b)(1) of Pub. L. 94–484 provided that the
enactment of sections 254l to 254r of this title and repeal of section 234 of this title by Pub. L. 94–484 is effective Oct. 1, 1977.
EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION
Section 408(b)(2) of Pub. L. 94–484, as amended, eff.
Oct. 12, 1976, by Pub. L. 95–83, title III, § 307(p), Aug. 1,
1977, 91 Stat. 394, provided that:
‘‘(A) Except as provided in subparagraphs (B) and (C),
the amendment made by paragraph (1) of this sub-

Page 310

section [enacting this section and sections 254l–1 to 254r
of this title and repealing section 234 of this title] shall
apply with respect to scholarships awarded under the
National Health Service Corps Scholarship Program
from appropriations for such Program for fiscal years
beginning after September 30, 1977.
‘‘(B) The provisions of section 225(f)(1) of the Public
Health Service Act (as in effect on September 30, 1977)
[former section 234(f)(1) of this title] prescribing the financial obligation of a participant in the Public Health
and National Health Service Corps Scholarship Program who fails to complete an active duty service obligation incurred under that Program shall apply to any
individual who received a scholarship under such Program from appropriations for such Program for any fiscal year ending before October 1, 1977.
‘‘(C) If an individual received a scholarship under the
Public Health and National Health Service Corps
Scholarship Program for any school year beginning before the date of the enactment of this Act [Oct. 12,
1976], periods of internship or residency served by such
individual in a facility of the National Health Service
Corps or other facility of the Public Health Service
shall be creditable in satisfying such individual’s service obligation incurred under that Program for such
scholarship or for any scholarship received under the
National Health Service Corps Scholarship Program for
any subsequent school year. If an individual received a
scholarship under the Public Health and National
Health Service Corps Program for the first time from
appropriations for such Program for the fiscal year
ending September 30, 1977, periods of internship or residency served by such individual in such a facility shall
be creditable in satisfying such individual’s service obligation incurred under that Program for such scholarship.’’
SCHOLARSHIP AND LOAN REPAYMENT PROGRAMS
Pub. L. 107–251, title III, § 302(c), Oct. 26, 2002, 116 Stat.
1644, provided that: ‘‘The Secretary of Health and
Human Services, in consultation with organizations
representing individuals in the dental field and organizations representing publicly funded health care providers, shall develop and implement a plan for increasing the participation of dentists and dental hygienists
in the National Health Service Corps Scholarship Program under section 338A of the Public Health Service
Act (42 U.S.C. 254l) and the Loan Repayment Program
under section 338B of such Act (42 U.S.C. 254l–1).’’

§ 254l–1. National Health Service Corps Loan Repayment Program
(a) Establishment
The Secretary shall establish a program to be
known as the National Health Service Corps
Loan Repayment Program to assure, with respect to the provision of primary health services
pursuant to section 254d(a)(2) of this title—
(1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse midwives, certified
nurse practitioners, and physician assistants;
and
(2) if needed by the Corps, an adequate supply of other health professionals.
(b) Eligibility
To be eligible to participate in the Loan Repayment Program, an individual must—
(1)(A) have a degree in medicine, osteopathic
medicine, dentistry, or another health profession, or an appropriate degree from a graduate
program of behavioral and mental health, or
be certified as a nurse midwife, nurse practitioner, or physician assistant;
(B) be enrolled in an approved graduate
training program in medicine, osteopathic

Page 311

TITLE 42—THE PUBLIC HEALTH AND WELFARE

medicine, dentistry, behavioral and mental
health, or other health profession; or
(C) be enrolled as a full-time student—
(i) in an accredited (as determined by the
Secretary) educational institution in a
State; and
(ii) in the final year of a course of a study
or program, offered by such institution and
approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as
a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps; and
(3) submit to the Secretary an application
for a contract described in subsection (f) of
this section (relating to the payment by the
Secretary of the educational loans of the individual in consideration of the individual serving for a period of obligated service).
(c) Information to be included with application
and contract forms; understandability; availability
(1) Summary and information
In disseminating application forms and contract forms to individuals desiring to participate in the Loan Repayment Program, the
Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is
approved (and whose contract is accepted)
by the Secretary, including in the summary
a clear explanation of the damages to which
the United States is entitled under section
254o of this title in the case of the individual’s breach of the contract; and
(B) information respecting meeting a service obligation through private practice
under an agreement under section 254n of
this title and such other information as may
be necessary for the individual to understand the individual’s prospective participation in the Loan Repayment Program and
service in the Corps.
(2) Understandability
The application form, contract form, and all
other information furnished by the Secretary
under this subpart shall be written in a manner calculated to be understood by the average
individual applying to participate in the Loan
Repayment Program.
(3) Availability
The Secretary shall make such application
forms, contract forms, and other information
available to individuals desiring to participate
in the Loan Repayment Program on a date
sufficiently early to ensure that such individuals have adequate time to carefully review
and evaluate such forms and information.
(4) Recruitment and retention
(A) The Secretary shall distribute to health
professions schools materials providing information on the Loan Repayment Program and
shall encourage the schools to disseminate the
materials to the students of the schools.
(B)(i) In the case of any health professional
whose period of obligated service under the

§ 254l–1

Loan Repayment Program is nearing completion, the Secretary shall encourage the individual to remain in a health professional
shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated service
under the Loan Repayment Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional
shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the Loan Repayment Program are assigned under section 254f of this title, the Secretary shall encourage the entities to provide
options with respect to assisting the participants in remaining in the health professional
shortage areas involved, and in continuing to
provide primary health services, after the period of obligated service under the Loan Repayment Program is completed. The options
with respect to which the Secretary provides
such encouragement may include options regarding the sharing of a single employment
position in the health professions by 2 or more
health professionals, and options regarding
the recruitment of couples where both of the
individuals are health professionals.
(d) Factors considered in providing contracts;
priorities
(1) Subject to section 254f–1 of this title, in
providing contracts under the Loan Repayment
Program—
(A) the Secretary shall consider the extent
of the demonstrated interest of the applicants
for the contracts in providing primary health
services; and
(B) may consider such other factors regarding the applicants as the Secretary determines
to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Loan Repayment Program, the Secretary shall give priority—
(A) to any application for such a contract
submitted by an individual whose training is
in a health profession or specialty determined
by the Secretary to be needed by the Corps;
(B) to any application for such a contract
submitted by an individual who has (and
whose spouse, if any, has) characteristics that
increase the probability that the individual
will continue to serve in a health professional
shortage area after the period of obligated
service pursuant to subsection (f) of this section is completed; and
(C) subject to subparagraph (B), to any application for such a contract submitted by an
individual who is from a disadvantaged background.
(e) Approval required for participation
An individual becomes a participant in the
Loan Repayment Program only upon the Secretary and the individual entering into a written contract described in subsection (f) of this
section.

§ 254l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Contents of contracts
The written contract (referred to in this subpart) between the Secretary and an individual
shall contain—
(1) an agreement that—
(A) subject to paragraph (3), the Secretary
agrees—
(i) to pay on behalf of the individual
loans in accordance with subsection (g) of
this section; and
(ii) to accept (subject to the availability
of appropriated funds for carrying out sections 254d through 254h of this title and
section 254j of this title) the individual
into the Corps (or for equivalent service as
otherwise provided in this subpart); and
(B) subject to paragraph (3), the individual
agrees—
(i) to accept loan payments on behalf of
the individual;
(ii) in the case of an individual described
in subsection (b)(1)(C) of this section, to
maintain enrollment in a course of study
or training described in such subsection
until the individual completes the course
of study or training;
(iii) in the case of an individual described in subsection (b)(1)(C) of this section, while enrolled in such course of study
or training, to maintain an acceptable
level of academic standing (as determined
under regulations of the Secretary by the
educational institution offering such
course of study or training); and
(iv) to serve for a time period (hereinafter in this subpart referred to as the ‘‘period of obligated service’’) equal to 2 years
or such longer period as the individual
may agree to, as a provider of primary
health services in a health professional
shortage area (designated under section
254e of this title) to which such individual
is assigned by the Secretary as a member
of the Corps or released under section 254n
of this title;
(2) a provision permitting the Secretary to
extend for such longer additional periods, as
the individual may agree to, the period of obligated service agreed to by the individual
under paragraph (1)(B)(iv), including extensions resulting in an aggregate period of obligated service in excess of 4 years;
(3) a provision that any financial obligation
of the United States arising out of a contract
entered into under this subpart and any obligation of the individual that is conditioned
thereon, is contingent on funds being appropriated for loan repayments under this subpart
and to carry out the purposes of sections 254d
through 254h of this title and sections 254j and
254k of this title;
(4) a statement of the damages to which the
United States is entitled, under section 254o of
this title for the individual’s breach of the
contract; and
(5) such other statements of the rights and
liabilities of the Secretary and of the individual, not inconsistent with this subpart.

Page 312

(g) Payments
(1) In general
A loan repayment provided for an individual
under a written contract under the Loan Repayment Program shall consist of payment, in
accordance with paragraph (2), on behalf of the
individual of the principal, interest, and related expenses on government and commercial
loans received by the individual regarding the
undergraduate or graduate education of the
individual (or both), which loans were made
for—
(A) tuition expenses;
(B) all other reasonable educational expenses, including fees, books, and laboratory
expenses, incurred by the individual; or
(C) reasonable living expenses as determined by the Secretary.
(2) Payments for years served
(A) In general
For each year of obligated service that an
individual contracts to serve under subsection (f) of this section the Secretary may
pay up to $50,000, plus, beginning with fiscal
year 2012, an amount determined by the Secretary on an annual basis to reflect inflation, on behalf of the individual for loans described in paragraph (1). In making a determination of the amount to pay for a year of
such service by an individual, the Secretary
shall consider the extent to which each such
determination—
(i) affects the ability of the Secretary to
maximize the number of contracts that
can be provided under the Loan Repayment Program from the amounts appropriated for such contracts;
(ii) provides an incentive to serve in
health professional shortage areas with
the greatest such shortages; and
(iii) provides an incentive with respect
to the health professional involved remaining in a health professional shortage
area, and continuing to provide primary
health services, after the completion of
the period of obligated service under the
Loan Repayment Program.
(B) Repayment schedule
Any arrangement made by the Secretary
for the making of loan repayments in accordance with this subsection shall provide
that any repayments for a year of obligated
service shall be made no later than the end
of the fiscal year in which the individual
completes such year of service.
(3) Tax liability
For the purpose of providing reimbursements for tax liability resulting from payments under paragraph (2) on behalf of an individual—
(A) the Secretary shall, in addition to such
payments, make payments to the individual
in an amount equal to 39 percent of the total
amount of loan repayments made for the
taxable year involved; and
(B) may make such additional payments as
the Secretary determines to be appropriate
with respect to such purpose.

Page 313

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) Payment schedule
The Secretary may enter into an agreement
with the holder of any loan for which payments are made under the Loan Repayment
Program to establish a schedule for the making of such payments.
(h) Employment ceiling
Notwithstanding any other provision of law,
individuals who have entered into written contracts with the Secretary under this section,
while undergoing academic or other training,
shall not be counted against any employment
ceiling affecting the Department.
(July 1, 1944, ch. 373, title III, § 338B, as added
Pub. L. 100–177, title II, § 201(3), Dec. 1, 1987, 101
Stat. 992; amended Pub. L. 100–607, title VI,
§ 629(a)(2), Nov. 4, 1988, 102 Stat. 3146; Pub. L.
101–597, title II, § 202(a)–(g)(1), (h), title IV,
§ 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3023–3026, 3035;
Pub. L. 105–392, title I, § 109, Nov. 13, 1998, 112
Stat. 3562; Pub. L. 107–251, title III, § 310, Oct. 26,
2002, 116 Stat. 1650; Pub. L. 108–163, § 2(k), Dec. 6,
2003, 117 Stat. 2022; Pub. L. 111–148, title X,
§ 10501(n)(4), Mar. 23, 2010, 124 Stat. 1003.)
PRIOR PROVISIONS
A prior section 338B of act July 1, 1944, was renumbered section 338C by section 201(2) of Pub. L. 100–177
and is classified to section 254m of this title.
AMENDMENTS
2010—Subsec. (g)(2)(A). Pub. L. 111–148 substituted
‘‘$50,000, plus, beginning with fiscal year 2012, an
amount determined by the Secretary on an annual
basis to reflect inflation,’’ for ‘‘$35,000’’ in introductory
provisions.
2003—Subsec. (e). Pub. L. 108–163 made technical
amendment.
2002—Subsec. (a)(1). Pub. L. 107–251, § 310(1)(A), inserted ‘‘behavioral and mental health professionals,’’
after ‘‘dentists,’’.
Subsec. (a)(2). Pub. L. 107–251, § 310(1)(B), struck out
‘‘(including mental health professionals)’’ before period
at end.
Subsec. (b)(1)(A). Pub. L. 107–251, § 310(2), added subpar. (A) and struck out former subpar. (A) which read
as follows: ‘‘must have a degree in medicine, osteopathic medicine, dentistry, or other health profession,
or be certified as a nurse midwife, nurse practioner, or
physician assistant;’’.
Subsec. (e)(1). Pub. L. 107–251, § 310(3), struck out par.
(1) designation and heading.
Subsec. (i). Pub. L. 107–251, § 310(4), struck out subsec.
(i), which required an annual report to Congress about
the Loan Repayment Program.
1998—Subsec. (b)(1)(B). Pub. L. 105–392 substituted
‘‘behavioral and mental health, or other health profession’’ for ‘‘or other health profession’’.
1990—Subsec. (a). Pub. L. 101–597, § 202(a)(1), substituted ‘‘Corps Loan Repayment Program to assure,
with respect to the provision of primary health services
pursuant to section 254d(a)(2) of this title—’’ and pars.
(1) and (2) for ‘‘Corps Loan Repayment Program (hereinafter in this subpart referred to as the ‘Loan Repayment Program’) in order to assure—
‘‘(1) an adequate supply of trained physicians, dentists, and nurses for the Corps; and
‘‘(2) if needed by the Corps, an adequate supply of
podiatrists, optometrists, pharmacists, clinical psychologists, graduates of schools of veterinary medicine, graduates of schools of public health, graduates
of programs in health administration, graduates of
programs for the training of physician assistants, expanded function dental auxiliaries, and nurse practitioners (as defined in section 296m of this title), and
other health professionals.’’

§ 254l–1

Subsec. (b)(1). Pub. L. 101–597, § 202(b)(1)(A), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows:
‘‘(A) be enrolled—
‘‘(i) as a full-time student—
‘‘(I) in an accredited (as determined by the Secretary) educational institution in a State; and
‘‘(II) in the final year of a course of study or program, offered by such institution and approved by
the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession; or
‘‘(ii) in an approved graduate training program in
medicine, osteopathic medicine, dentistry, or other
health profession; or
‘‘(B) have—
‘‘(i) a degree in medicine, osteopathic medicine,
dentistry, or other health profession;
‘‘(ii) completed an approved graduate training program in medicine, osteopathic medicine, dentistry, or
other health profession in a State, except that the
Secretary may waive the completion requirement of
this clause for good cause; and
‘‘(iii) a license to practice medicine, osteopathic
medicine, dentistry, or other health profession in a
State;’’.
Subsec. (b)(2) to (4). Pub. L. 101–597, § 202(b)(2)(A), inserted ‘‘and’’ at end of par. (2), added par. (3), and
struck out former pars. (3) and (4) which read as follows:
‘‘(3) submit an application to participate in the Loan
Repayment Program; and
‘‘(4) sign and submit to the Secretary, at the time of
the submission of such application, a written contract
(described in subsection (f) of this section) to accept repayment of educational loans and to serve (in accordance with this subpart) for the applicable period of obligated service in a health manpower shortage area.’’
Subsec. (c)(4). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in subpars.
(B) and (C).
Pub. L. 101–597, § 202(c), added par. (4).
Subsec. (d). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (2)(B).
Pub. L. 101–597, § 202(d), amended subsec. (d) generally. Prior to amendment, subsec. (d) read as follows:
‘‘In determining which applications under the Loan Repayment Program to approve (and which contracts to
accept), the Secretary shall give priority to applications made by—
‘‘(1) individuals whose training is in a health profession or specialty determined by the Secretary to be
needed by the Corps; and
‘‘(2) individuals who are committed to service in
medically underserved areas.’’
Subsec. (e). Pub. L. 101–597, § 202(b)(2)(B), substituted
‘‘only upon the Secretary and the individual entering
into a written contract described in subsection (f) of
this section.’’ for ‘‘only on the Secretary’s approval of
the individual’s application submitted under subsection
(b)(3) of this section and the Secretary’s acceptance of
the contract submitted by the individual under subsection (b)(4) of this section.’’ in par. (1) and struck out
par. (2) which read as follows: ‘‘The Secretary shall provide written notice to an individual promptly on—
‘‘(A) the Secretary’s approving, under paragraph
(1), of the individual’s participation in the Loan Repayment Program; or
‘‘(B) the Secretary’s disapproving an individual’s
participation in such Program.’’
Subsec. (f)(1)(B)(ii), (iii). Pub. L. 101–597, § 202(b)(1)(B),
substituted ‘‘subsection (b)(1)(C)’’ for ‘‘subsection
(b)(1)(A)’’.
Subsec. (f)(1)(B)(iv). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area.
Pub. L. 101–597, § 202(a)(2), inserted ‘‘as a provider of
primary health services’’ before ‘‘in a health’’.

§ 254m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (f)(2). Pub. L. 101–597, § 202(e), inserted before
semicolon at end ‘‘, including extensions resulting in
an aggregate period of obligated service in excess of 4
years’’.
Subsec. (g)(1). Pub. L. 101–597, § 202(f)(1), inserted ‘‘regarding the undergraduate or graduate education of the
individual (or both), which loans were made’’ after
‘‘loans received by the individual’’.
Subsec. (g)(2)(A). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area in cls.
(ii) and (iii).
Pub. L. 101–597, § 202(f)(2)(A), substituted ‘‘For each
year’’ for ‘‘Except as provided in subparagraph (B) and
paragraph (3), for each year’’ and ‘‘$35,000’’ for
‘‘$20,000’’, inserted at end ‘‘In making a determination
of the amount to pay for a year of such service by an
individual, the Secretary shall consider the extent to
which each such determination—’’, and added immediately thereafter cls. (i) to (iii).
Subsec. (g)(2)(B), (C). Pub. L. 101–597, § 202(f)(2)(B), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: ‘‘For each year of obligated service that an individual contracts under subsection (f) of this section to serve in the Indian Health
Service, or to serve in a health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act (25 U.S.C. 450f et seq.), the
Secretary may pay up to $25,000 on behalf of the individual for loans described in paragraph (1).’’
Subsec. (g)(3). Pub. L. 101–597, § 202(g)(1), amended par.
(3) generally. Prior to amendment, par. (3) read as follows: ‘‘In addition to payments made under paragraph
(2), in any case in which payments on behalf of an individual under the Loan Repayment Program result in an
increase in Federal, State, or local income tax liability
for such individual, the Secretary may, on the request
of such individual, make payments to such individual
in a reasonable amount, as determined by the Secretary, to reimburse such individual for all or part of
the increased tax liability of the individual.’’
Subsec. (i). Pub. L. 101–597, § 401(b)[(a)], substituted
reference to health professional shortage area for reference to health manpower shortage area in par. (8).
Pub. L. 101–597, § 202(h), amended subsec. (i) generally.
Prior to amendment, subsec. (i) read as follows: ‘‘The
Secretary shall, not later than March 1 of each year,
submit to the Congress a report specifying—
‘‘(1) the number, and type of health profession
training, of individuals receiving loan payments
under the Loan Repayment Program;
‘‘(2) the educational institution at which such individuals are receiving their training;
‘‘(3) the number of applications filed under this section in the school year beginning in such year and in
prior school years; and
‘‘(4) the amount of loan payments made in the year
reported on.’’
1988—Subsec. (b)(1). Pub. L. 100–607 substituted ‘‘osteopathic medicine’’ for ‘‘osteopathy’’ wherever appearing.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Pub. L. 101–597, title II, § 202(g)(2), Nov. 16, 1990, 104
Stat. 3026, provided that: ‘‘The amendment made by
paragraph (1) [amending this section] shall apply only
with respect to contracts under section 338B of the
Public Health Service Act [this section] (relating to
service in the National Health Service Corps) that are
entered into on or after the effective date of this Act
[Nov. 16, 1990].’’
REGULATIONS
Section 205 of title II of Pub. L. 100–177 provided that:
‘‘Not later than 180 days after the effective date of the

Page 314

amendments made by this title [Dec. 21, 1987], the Secretary of Health and Human Services shall issue regulations for the loan repayment programs established by
the amendments [enacting this section and sections
254q and 254q–1 of this title, amending sections 242a,
254d, 254g, 254h–1, and 254o of this title, and repealing
former section 254q of this title].’’

§ 254m. Obligated service under contract
(a) Service in full-time clinical practice
Except as provided in section 254n of this title,
each individual who has entered into a written
contract with the Secretary under section 254l
or 254l–1 of this title shall provide service in the
full-time clinical practice of such individual’s
profession as a member of the Corps for the period of obligated service provided in such contract. The Secretary may treat teaching as clinical practice for up to 20 percent of such period
of obligated service. Notwithstanding the preceding sentence, with respect to a member of
the Corps participating in the teaching health
centers graduate medical education program
under section 256h of this title, for the purpose
of calculating time spent in full-time clinical
practice under this section, up to 50 percent of
time spent teaching by such member may be
counted toward his or her service obligation.
(b) Notice to individual; information for informed decision; eligibility; notice to Secretary; qualification and appointment as
commissioned officer; appointment as civilian member; designation of non-United
States employee as member; deferment of obligated service
(1) If an individual is required under subsection (a) of this section to provide service as
specified
in
section
254l(f)(1)(B)(v)
or
254l–1(f)(1)(B)(iv) of this title (hereinafter in this
subsection referred to as ‘‘obligated service’’),
the Secretary shall, not later than ninety days
before the date described in paragraph (5), determine if the individual shall provide such service—
(A) as a member of the Corps who is a commissioned officer in the Regular or Reserve
Corps of the Service or who is a civilian employee of the United States, or
(B) as a member of the Corps who is not such
an officer or employee,
and shall notify such individual of such determination.
(2) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is a commissioned officer
in the Service or a civilian employee of the
United States, the Secretary shall, not later
than sixty days before the date described in
paragraph (5), provide such individual with sufficient information regarding the advantages and
disadvantages of service as such a commissioned
officer or civilian employee to enable the individual to make a decision on an informed basis.
To be eligible to provide obligated service as a
commissioned officer in the Service, an individual shall notify the Secretary, not later than
thirty days before the date described in paragraph (5), of the individual’s desire to provide
such service as such an officer. If an individual
qualifies for an appointment as such an officer,

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the Secretary shall, as soon as possible after the
date described in paragraph (5), appoint the individual as a commissioned officer of the Regular
or Reserve Corps of the Service and shall designate the individual as a member of the Corps.
(3) If an individual provided notice by the Secretary under paragraph (2) does not qualify for
appointment as a commissioned officer in the
Service, the Secretary shall, as soon as possible
after the date described in paragraph (5), appoint such individual as a civilian employee of
the United States and designate the individual
as a member of the Corps.
(4) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is not an employee of the
United States, the Secretary shall, as soon as
possible after the date described in paragraph
(5), designate such individual as a member of the
Corps to provide such service.
(5)(A) In the case of the Scholarship Program,
the date referred to in paragraphs (1) through (4)
shall be the date on which the individual completes the training required for the degree for
which the individual receives the scholarship,
except that—
(i) for an individual receiving such a degree
after September 30, 2000, from a school of medicine or osteopathic medicine, such date shall
be the date the individual completes a residency in a specialty that the Secretary determines is consistent with the needs of the
Corps; and
(ii) at the request of an individual, the Secretary may, consistent with the needs of the
Corps, defer such date until the end of a period
of time required for the individual to complete
advanced training (including an internship or
residency).
(B) No period of internship, residency, or other
advanced clinical training shall be counted toward satisfying a period of obligated service
under this subpart.
(C) In the case of the Loan Repayment Program, if an individual is required to provide obligated service under such Program, the date referred to in paragraphs (1) through (4)—
(i) shall be the date determined under subparagraph (A) in the case of an individual who
is enrolled in the final year of a course of
study;
(ii) shall, in the case of an individual who is
enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession, be the date
the individual completes such training program; and
(iii) shall, in the case of an individual who
has a degree in medicine, osteopathic medicine, dentistry, or other health profession and
who has completed graduate training, be the
date the individual enters into an agreement
with the Secretary under section 254l–1 of this
title.
(c) Obligated service period; commencement
An individual shall be considered to have
begun serving a period of obligated service—
(1) on the date such individual is appointed
as an officer in a Regular or Reserve Corps of
the Service or is designated as a member of

§ 254m

the Corps under subsection (b)(3) or (b)(4) of
this section, or
(2) in the case of an individual who has entered into an agreement with the Secretary
under section 254n of this title, on the date
specified in such agreement,
whichever is earlier.
(d) Assignment of personnel
The Secretary shall assign individuals performing obligated service in accordance with a
written contract under the Scholarship Program
to health professional shortage areas in accordance with sections 254d through 254h and sections 254j and 254k of this title. If the Secretary
determines that there is no need in a health professional shortage area (designated under section 254e of this title) for a member of the profession in which an individual is obligated to
provide service under a written contract and if
such individual is an officer in the Service or a
civilian employee of the United States, the Secretary may detail such individual to serve his
period of obligated service as a full-time member of such profession in such unit of the Department as the Secretary may determine.
(July 1, 1944, ch. 373, title III, § 338C, formerly
title VII, § 752, as added Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2284; amended
Pub. L. 95–626, title I, § 113(b), Nov. 10, 1978, 92
Stat. 3563; Pub. L. 96–76, title II, § 202(a), (b),
Sept. 29, 1979, 93 Stat. 582; renumbered § 338B and
amended Pub. L. 97–35, title XXVII, § 2709(a), (c),
Aug. 13, 1981, 95 Stat. 908, 909; Pub. L. 97–414,
§ 8(g)(1), Jan. 4, 1983, 96 Stat. 2061; renumbered
§ 338C and amended Pub. L. 100–177, title II,
§ 201(2), title III, § 306, Dec. 1, 1987, 101 Stat. 992,
1004; Pub. L. 100–607, title VI, § 629(a)(2), Nov. 4,
1988, 102 Stat. 3146; Pub. L. 101–597, title IV,
§ 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3035; Pub. L.
107–251, title III, § 311, Oct. 26, 2002, 116 Stat. 1650;
Pub. L. 111–148, title V, § 5508(b), title X,
§ 10501(n)(5), Mar. 23, 2010, 124 Stat. 670, 1003.)
CODIFICATION
Section was formerly classified to section 294u of this
title prior to its renumbering by Pub. L. 97–35.
PRIOR PROVISIONS
A prior section 338C of act July 1, 1944, was renumbered section 338D by section 201(2) of Pub. L. 100–177
and is classified to section 254n of this title.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 10501(n)(5), in second sentence, substituted ‘‘The Secretary may treat
teaching as clinical practice for up to 20 percent of such
period of obligated service’’ for ‘‘For the purpose of calculating time spent in full-time clinical practice under
this subsection, up to 50 percent of time spent teaching
by a member of the Corps may be counted toward his
or her service obligation’’ and inserted at end ‘‘Notwithstanding the preceding sentence, with respect to a
member of the Corps participating in the teaching
health centers graduate medical education program
under section 256h of this title, for the purpose of calculating time spent in full-time clinical practice under
this section, up to 50 percent of time spent teaching by
such member may be counted toward his or her service
obligation.’’
Pub. L. 111–148, § 5508(b), amended subsec. (a) generally. Prior to amendment, text read as follows: ‘‘Except
as provided in section 254n of this title, each individual

§ 254m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

who has entered into a written contract with the Secretary under section 254l or 254l–1 of this title shall provide service in the full-time clinical practice of such individual’s profession as a member of the Corps for the
period of obligated service provided in such contract.’’
2002—Subsec. (b)(1). Pub. L. 107–251, § 311(1)(A), substituted ‘‘section 254l(f)(1)(B)(v)’’ for ‘‘254l(f)(1)(B)(iv)’’
in introductory provisions.
Subsec. (b)(5)(A). Pub. L. 107–251, § 311(1)(B)(i), added
subpar. (A) and struck out former subpar. (A) which
read as follows: ‘‘In the case of the Scholarship Program, with respect to an individual receiving a degree
from a school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatry, or
pharmacy, the date referred to in paragraphs (1)
through (4) shall be the date on which the individual
completes the training required for such degree, except
that—
‘‘(i) at the request of such an individual with whom
the Secretary has entered into a contract under section 254l of this title prior to October 1, 1985, the Secretary shall defer such date until the end of the period of time (not to exceed the number of years specified in subparagraph (B) or such greater period as the
Secretary, consistent with the needs of the Corps,
may authorize) required for the individual to complete an internship, residency, or other advanced
clinical training; and
‘‘(ii) at the request of such an individual with whom
the Secretary has entered into a contract under section 254l of this title on or after October 1, 1985, the
Secretary may defer such date in accordance with
clause (i).’’
Subsec. (b)(5)(B). Pub. L. 107–251, § 311(1)(B)(i), (iii), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows:
‘‘(B)(i) In the case of the Scholarship Program, with
respect to an individual receiving a degree from a
school of medicine, osteopathic medicine, or dentistry,
the number of years referred to in subparagraph (A)(i)
shall be 3 years.
‘‘(ii) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school
of veterinary medicine, optometry, podiatry, or pharmacy, the number of years referred to in subparagraph
(A)(i) shall be 1 year.’’
Subsec. (b)(5)(C). Pub. L. 107–251, § 311(1)(B)(iii), redesignated subpar. (E) as (C). Former subpar. (C) redesignated (B).
Subsec. (b)(5)(C)(i). Pub. L. 107–251, § 311(1)(B)(iv), substituted ‘‘subparagraph (A)’’ for ‘‘subparagraph (A), (B),
or (D)’’.
Subsec. (b)(5)(D). Pub. L. 107–251, § 311(1)(B)(ii), struck
out subpar. (D) which read as follows: ‘‘In the case of
the Scholarship Program, with respect to an individual
receiving a degree from an institution other than a
school referred to in subparagraph (A), the date referred to in paragraphs (1) through (4) shall be the date
on which the individual completes the academic training of the individual leading to such degree.’’
Subsec. (b)(5)(E). Pub. L. 107–251, § 311(1)(B)(iii), redesignated subpar. (E) as (C).
Subsec. (e). Pub. L. 107–251, § 311(2), struck out subsec.
(e) which related to service under National Research
Service Award program as credit against obligated
service time.
1990—Subsec. (d). Pub. L. 101–597 substituted reference to health professional shortage area for reference to health manpower shortage area wherever appearing.
1988—Subsec. (b)(5). Pub. L. 100–607 substituted ‘‘osteopathic medicine’’ for ‘‘osteopathy’’ wherever appearing.
1987—Subsec. (a). Pub. L. 100–177, § 306(1), inserted ‘‘or
254l–1’’, and made technical amendment to reference to
section 254n of this title to reflect renumbering of corresponding section of original act.
Subsec. (b)(1). Pub. L. 100–177, § 306(2), inserted reference to section 254l–l(f)(1)(B)(iv).
Subsec. (b)(5). Pub. L. 100–177, § 306(3), substituted par.
(5) consisting of subpars. (A) to (E) for former par. (5)
consisting of subpars. (A) and (B).

Page 316

Subsec. (c)(2). Pub. L. 100–177, § 306(4), made technical
amendment to reference to section 254n of this title to
reflect renumbering of corresponding section of original act.
1983—Subsec. (e). Pub. L. 97–414 inserted ‘‘or under
section 234 of this title as in effect on September 30,
1977’’ after ‘‘Scholarship Program’’.
1981—Subsec. (a). Pub. L. 97–35, § 2709(c)(1), substituted ‘‘254n’’ for ‘‘294v’’ and ‘‘254l’’ for ‘‘294t’’.
Subsec. (b). Pub. L. 97–35, § 2709(c)(2), substituted provisions relating to notice, information, etc., for individuals required to give obligated service, for provisions relating to notice, information, etc., for individuals required to provide service under the Scholarship
Program.
Subsec. (c). Pub. L. 97–35, § 2709(c)(3), (4), in par. (1) inserted reference to designation under subsec. (b)(3) or
(4) of this section, and in par. (2) substituted ‘‘254n’’ for
‘‘294v’’.
Subsec. (d). Pub. L. 97–35, § 2709(c)(5), inserted provision relating to individuals who are officers in the
Service or civilian employees of the United States, and
substituted reference to sections 254d to 254h, 254j, and
254k of this title, for reference to subpart II of part D
of subchapter II of this chapter.
Subsec. (e). Pub. L. 97–35, § 2709(c)(6), substituted provisions respecting mandatory determination of service
requirement, for provisions respecting discretionary
determination of service requirement.
1979—Subsec. (b)(5)(A). Pub. L. 96–76, § 202(a), (b)(1),
(2), inserted provisions authorizing a greater period
than three years for individuals receiving degrees from
schools of medicine, osteopathy, and dentistry, and
provisions respecting individuals receiving degrees
from schools of veterinary medicine, optometry, podiatry, and pharmacy, and substituted ‘‘No period’’ for
‘‘No such period’’.
Subsec. (b)(5)(B). Pub. L. 96–76, § 202(b)(3), substituted
‘‘referred to in subparagraph (A)’’ for ‘‘of medicine, osteopathy, or dentistry’’.
1978—Subsec. (d). Pub. L. 95–626 substituted ‘‘subpart
II of part D’’ for ‘‘subpart II of part C’’.
EFFECTIVE DATE OF 1981 AMENDMENT
Pub. L. 97–35, title XXVII, § 2709(h), Aug. 13, 1981, 95
Stat. 912, provided that: ‘‘The amendments made by
paragraphs (2), (3), and (5)(B) of subsection (c) [amending this section] shall apply with respect to contracts
entered into under the National Health Service Corps
scholarship program under subpart III of part C of title
VII of the Public Health Service Act [section 294r et
seq. of this title] after the date of the enactment of this
Act [Aug. 13, 1981]. An individual who before such date
has entered into such a contract and who has not begun
the period of obligated service required under such contract shall be given the opportunity to revise such contract to permit the individual to serve such period as
a member of the National Health Service Corps who is
not an employee of the United States.’’
EFFECTIVE DATE
Section effective Oct. 1, 1977, see section 408(b)(1) of
Pub. L. 94–484, set out in part as a note under section
254l of this title.
EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION
See section 408(b)(2) of Pub. L. 94–484, set out as a
note under section 254l of this title.
SPECIAL RETENTION PAY FOR REGULAR OR RESERVE
OFFICERS FOR PERIOD OFFICER IS OBLIGATED UNDER
THIS SECTION
Pub. L. 100–446, title II, Sept. 27, 1988, 102 Stat. 1816,
provided that: ‘‘the Secretary of Health and Human
Services may authorize special retention pay under
paragraph (4) of 37 U.S.C. 302(a) to any regular or reserve officer for the period during which the officer is

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

obligated under section 338B [now 338C] of the Public
Health Service Act [this section] and assigned and providing direct health services or serving the officer’s obligation as a specialist’’.
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 100–202, § 101(g) [title II], Dec. 22, 1987, 101
Stat. 1329–213, 1329–246.
Pub. L. 99–500, § 101(h) [title II], Oct. 18, 1986, 100 Stat.
1783–242, 1783–277, and Pub. L. 99–591, § 101(h) [title II],
Oct. 30, 1986, 100 Stat. 3341–242, 3341–277.

§ 254n. Private practice
(a) Application for release of obligations; conditions
The Secretary shall, to the extent permitted
by, and consistent with, the requirements of applicable State law, release an individual from all
or part of his service obligation under section
254m(a) of this title or under section 234 1 of this
title (as in effect on September 30, 1977) if the individual applies for such a release under this
section and enters into a written agreement
with the Secretary under which the individual
agrees to engage for a period equal to the remaining period of his service obligation in the
full-time private clinical practice (including
service as a salaried employee in an entity directly providing health services) of his health
profession—
(1) in the case of an individual who received
a scholarship under the Scholarship Program
or a loan repayment under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a
health professional shortage area on the date
of his application for such a release, in the
health professional shortage area in which
such individual is serving on such date or in
the case of an individual for whom a loan payment was made under the Loan Repayment
Program and who is performing obligated
service as a member of the Corps in a health
professional shortage area on the date of the
application of the individual for such a release, in the health professional shortage area
selected by the Secretary; or
(2) in the case of any other individual, in a
health professional shortage area (designated
under section 254e of this title) selected by the
Secretary.
(b) Written agreement; actions to ensure compliance
(1) The written agreement described in subsection (a) of this section shall—
(A) provide that, during the period of private
practice by an individual pursuant to the
agreement, the individual shall comply with
the requirements of section 254g of this title
that apply to entities; and
(B) contain such additional provisions as the
Secretary may require to carry out the objectives of this section.
(2) The Secretary shall take such action as
may be appropriate to ensure that the conditions of the written agreement prescribed by
this subsection are adhered to.
(c) Breach of service contract
If an individual breaches the contract entered
into under section 254l or 254l–1 of this title by
1 See

References in Text note below.

§ 254n

failing (for any reason) to begin his service obligation in accordance with an agreement entered
into under subsection (a) of this section or to
complete such service obligation, the Secretary
may permit such individual to perform such
service obligation as a member of the Corps.
(d) Travel expenses
The Secretary may pay an individual who has
entered into an agreement with the Secretary
under subsection (a) of this section an amount
to cover all or part of the individual’s expenses
reasonably incurred in transporting himself, his
family, and his possessions to the location of his
private clinical practice.
(e) Sale of equipment and supplies
Upon the expiration of the written agreement
under subsection (a) of this section, the Secretary may (notwithstanding any other provision of law) sell to the individual who has entered into an agreement with the Secretary
under subsection (a) of this section, equipment
and other property of the United States utilized
by such individual in providing health services.
Sales made under this subsection shall be made
at the fair market value (as determined by the
Secretary) of the equipment or such other property, except that the Secretary may make such
sales for a lesser value to the individual if he determines that the individual is financially unable to pay the full market value.
(f) Malpractice insurance
The Secretary may, out of appropriations authorized under section 254k of this title, pay to
individuals participating in private practice
under this section the cost of such individual’s
malpractice insurance and the lesser of—
(1)(A) $10,000 in the first year of obligated
service;
(B) $7,500 in the second year of obligated
service;
(C) $5,000 in the third year of obligated service; and
(D) $2,500 in the fourth year of obligated
service; or
(2) an amount determined by subtracting
such individual’s net income before taxes from
the income the individual would have received
as a member of the Corps for each such year of
obligated service.
(g) Technical assistance
The Secretary shall, upon request, provide to
each individual released from service obligation
under this section technical assistance to assist
such individual in fulfilling his or her agreement
under this section.
(July 1, 1944, ch. 373, title III, § 338D, formerly
title VII, § 753, as added Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2285; amended
Pub. L. 96–538, title IV, § 403, Dec. 17, 1980, 94
Stat. 3192; renumbered § 338C and amended Pub.
L. 97–35, title XXVII, § 2709(a), (d), Aug. 13, 1981,
95 Stat. 908, 910; renumbered § 338D and amended
Pub. L. 100–177, title II, § 201(2), title III, § 307,
Dec. 1, 1987, 101 Stat. 992, 1005; Pub. L. 101–597,
title IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3035;
Pub. L. 107–251, title III, § 312, Oct. 26, 2002, 116
Stat. 1650.)

§ 254o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 318

REFERENCES IN TEXT

EFFECTIVE DATE

Section 234 of this title, referred to in subsec. (a), was
repealed by Pub. L. 94–484, title IV, § 408(b)(1), Oct. 12,
1976, 90 Stat. 2281, effective Oct. 1, 1977.

Section effective Oct. 1, 1977, see section 408(b)(1) of
Pub. L. 94–484, set out in part as a note under section
254l of this title.

CODIFICATION

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

Section was formerly classified to section 294v of this
title prior to its renumbering by Pub. L. 97–35.
PRIOR PROVISIONS
A prior section 338D of act July 1, 1944, was renumbered section 338E by section 201(2) of Pub. L. 100–177
and is classified to section 254o of this title.
AMENDMENTS
2002—Subsec. (b). Pub. L. 107–251 added subsec. (b) and
struck out former subsec. (b) which related to written
agreements, regulations, and actions to ensure compliance.
1990—Subsec. (a)(1), (2). Pub. L. 101–597 substituted
reference to health professional shortage area for reference to health manpower shortage area wherever appearing.
1987—Subsec. (a). Pub. L. 100–177, § 307(1)–(3), made
technical amendment to reference to section 254m of
this title to reflect renumbering of corresponding section of original act, in introductory provisions, in par.
(1) inserted ‘‘who received a scholarship under the
Scholarship Program or a loan repayment under the
Loan Repayment Program and’’ after ‘‘individual’’ the
first time it appeared as the probable intent of Congress, and inserted ‘‘or in the case of an individual for
whom a loan payment was made under the Loan Repayment Program and who is performing obligated service
as a member of the Corps in a health manpower shortage area on the date of the application of the individual
for such a release, in the health manpower shortage
area selected by the Secretary’’, and in par. (2) inserted
‘‘selected by the Secretary’’.
Subsec. (b). Pub. L. 100–177, § 307(4), inserted at end
‘‘The Secretary shall take such action as may be appropriate to ensure that the conditions of the written
agreement prescribed by this subsection are adhered
to.’’
Subsec. (c). Pub. L. 100–177, § 307(5), inserted reference
to section 254l–1.
Subsec. (e). Pub. L. 100–177, § 307(b), designated par. (2)
as entire subsection and struck out par. (1) which read
as follows: ‘‘The Secretary may make such arrangements as he determines are necessary for the individual
for the use of equipment and supplies and for the lease
or acquisition of other equipment and supplies.’’
1981—Subsec. (a). Pub. L. 97–35, § 2709(d)(1), inserted
provision respecting requirements of applicable State
law, substituted references to sections 254m(a) and 234
of this title, for reference to section 294u(a) of this
title, and in cl. (2) struck out priority requirement
under section 254f(c) of this title.
Subsec. (b)(1)(B). Pub. L. 97–35, § 2709(d)(2), inserted
‘‘(i)’’ before ‘‘shall not’’ and added cl. (ii).
Subsecs. (c) to (g). Pub. L. 97–35, § 2709(d)(3), added
subsecs. (c) to (g).
1980—Subsec. (a). Pub. L. 96–538 substituted in par. (2)
‘‘which has’’ for ‘‘which (A) has’’ and struck out subpar.
(B) which referred to a health manpower shortage area
which has a sufficient financial base to substain private
practice and provide the individual with income of not
less than the income of members of the Corps, and
struck out provision following par. (2) which provided
that in the case of an individual described in par. (1),
the Secretary release the individual from his service
obligation under this subsection only if the Secretary
determines that the area in which the individual is
serving met the requirements of cl. (B) of par. (2).

See section 408(b)(2) of Pub. L. 94–484, set out as a
note under section 254l of this title.

§ 254o. Breach of scholarship contract or loan repayment contract
(a) Failure to maintain academic standing; dismissal from institution; voluntary termination; liability; failure to accept payment
(1) An individual who has entered into a written contract with the Secretary under section
254l of this title and who—
(A) fails to maintain an acceptable level of
academic standing in the educational institution in which he is enrolled (such level determined by the educational institution under
regulations of the Secretary);
(B) is dismissed from such educational institution for disciplinary reasons; or
(C) voluntarily terminates the training in
such an educational institution for which he is
provided a scholarship under such contract,
before the completion of such training,
in lieu of any service obligation arising under
such contract, shall be liable to the United
States for the amount which has been paid to
him, or on his behalf, under the contract.
(2) An individual who has entered into a written contract with the Secretary under section
254l–1 of this title and who—
(A) in the case of an individual who is enrolled in the final year of a course of study,
fails to maintain an acceptable level of academic standing in the educational institution
in which such individual is enrolled (such level
determined by the educational institution
under regulations of the Secretary) or voluntarily terminates such enrollment or is dismissed from such educational institution before completion of such course of study; or
(B) in the case of an individual who is enrolled in a graduate training program, fails to
complete such training program and does not
receive a waiver from the Secretary under section 254l–1(b)(1)(B)(ii) of this title,
in lieu of any service obligation arising under
such contract shall be liable to the United
States for the amount that has been paid on behalf of the individual under the contract.
(b) Failure to commence or complete service obligations; formula to determine liability; payment to United States; recovery of delinquent damages; disclosure to credit reporting agencies
(1)(A) Except as provided in paragraph (2), if
an individual breaches his written contract by
failing (for any reason not specified in subsection (a) of this section or section 254p(d) of
this title) to begin such individual’s service obligation under section 254l of this title in accordance with section 254m or 254n of this title, to
complete such service obligation, or to complete

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

a required residency as specified in section
254l(f)(1)(B)(iv) of this title, the United States
shall be entitled to recover from the individual
an amount determined in accordance with the
formula
t¥s
A=3φ

+——,
t

in which ‘‘A’’ is the amount the United States is
entitled to recover, ‘‘φ’’ is the sum of the
amounts paid under this subpart to or on behalf
of the individual and the interest on such
amounts which would be payable if at the time
the amounts were paid they were loans bearing
interest at the maximum legal prevailing rate,
as determined by the Treasurer of the United
States; ‘‘t’’ is the total number of months in the
individual’s period of obligated service; and ‘‘s’’
is the number of months of such period served
by him in accordance with section 254m of this
title or a written agreement under section 254n
of this title.
(B)(i) Any amount of damages that the United
States is entitled to recover under this subsection or under subsection (c) of this section
shall, within the 1-year period beginning on the
date of the breach of the written contract (or
such longer period beginning on such date as
specified by the Secretary), be paid to the
United States. Amounts not paid within such period shall be subject to collection through deductions in Medicare payments pursuant to section 1395ccc of this title.
(ii) If damages described in clause (i) are delinquent for 3 months, the Secretary shall, for the
purpose of recovering such damages—
(I) utilize collection agencies contracted
with by the Administrator of the General
Services Administration; or
(II) enter into contracts for the recovery of
such damages with collection agencies selected by the Secretary.
(iii) Each contract for recovering damages
pursuant to this subsection shall provide that
the contractor will, not less than once each 6
months, submit to the Secretary a status report
on the success of the contractor in collecting
such damages. Section 3718 of title 31 shall apply
to any such contract to the extent not inconsistent with this subsection.
(iv) To the extent not otherwise prohibited by
law, the Secretary shall disclose to all appropriate credit reporting agencies information relating to damages of more than $100 that are entitled to be recovered by the United States
under this subsection and that are delinquent by
more than 60 days or such longer period as is determined by the Secretary.
(2) If an individual is released under section
254n 1 of this title from a service obligation
under section 234 1 of this title (as in effect on
September 30, 1977) and if the individual does
not meet the service obligation incurred under
section 254n 1 of this title, subsection (f) of such
section 234 1 of this title shall apply to such individual in lieu of paragraph (1) of this subsection.
(3) The Secretary may terminate a contract
with an individual under section 254l of this title
1 See

References in Text note below.

§ 254o

if, not later than 30 days before the end of the
school year to which the contract pertains, the
individual—
(A) submits a written request for such termination; and
(B) repays all amounts paid to, or on behalf
of, the individual under section 254l(g) of this
title.
(c) Failure to commence or complete service obligations for other reasons; determination of
liability; payment to United States; waiver of
recovery for extreme hardship or good cause
shown
(1) If (for any reason not specified in subsection (a) of this section or section 254p(d) of
this title) an individual breaches the written
contract of the individual under section 254l–1 of
this title by failing either to begin such individual’s service obligation in accordance with section 254m or 254n of this title or to complete
such service obligation, the United States shall
be entitled to recover from the individual an
amount equal to the sum of—
(A) the total of the amounts paid by the
United States under section 254l–1(g) of this
title on behalf of the individual for any period
of obligated service not served;
(B) an amount equal to the product of the
number of months of obligated service that
were not completed by the individual, multiplied by $7,500; and
(C) the interest on the amounts described in
subparagraphs (A) and (B), at the maximum
legal prevailing rate, as determined by the
Treasurer of the United States, from the date
of the breach;
except that the amount the United States is entitled to recover under this paragraph shall not
be less than $31,000.
(2) The Secretary may terminate a contract
with an individual under section 254l–1 of this
title if, not later than 45 days before the end of
the fiscal year in which the contract was entered into, the individual—
(A) submits a written request for such termination; and
(B) repays all amounts paid on behalf of the
individual under section 254l–1(g) of this title.
(3) Damages that the United States is entitled
to recover shall be paid in accordance with subsection (b)(1)(B) of this section.
(d) Cancellation of obligation upon death of individual; waiver or suspension of obligation for
impossibility, hardship, or unconscionability;
release of debt by discharge in bankruptcy,
time limitations
(1) Any obligation of an individual under the
Scholarship Program (or a contract thereunder)
or the Loan Repayment Program (or a contract
thereunder) for service or payment of damages
shall be canceled upon the death of the individual.
(2) The Secretary shall by regulation provide
for the partial or total waiver or suspension of
any obligation of service or payment by an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) whenever compliance by the individual is impossible or would

§ 254o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

involve extreme hardship to the individual and
if enforcement of such obligation with respect to
any individual would be unconscionable.
(3)(A) Any obligation of an individual under
the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a
contract thereunder) for payment of damages
may be released by a discharge in bankruptcy
under title 11 only if such discharge is granted
after the expiration of the 7-year period beginning on the first date that payment of such damages is required, and only if the bankruptcy
court finds that nondischarge of the obligation
would be unconscionable.
(B)(i) Subparagraph (A) shall apply to any financial obligation of an individual under the
provision of law specified in clause (ii) to the
same extent and in the same manner as such
subparagraph applies to any obligation of an individual under the Scholarship or Loan Repayment Program (or contract thereunder) for payment of damages.
(ii) The provision of law referred to in clause
(i) is subsection (f) of section 234 2 of this title,
as in effect prior to the repeal of such section by
section 408(b)(1) of Public Law 94–484.
(e) Inapplicability of Federal and State statute of
limitations on actions for collection
Notwithstanding any other provision of Federal or State law, there shall be no limitation on
the period within which suit may be filed, a
judgment may be enforced, or an action relating
to an offset or garnishment, or other action,
may be initiated or taken by the Secretary, the
Attorney General, or the head of another Federal agency, as the case may be, for the repayment of the amount due from an individual
under this section.
(f) Effective date
The amendment made by section 313(a)(4) of
the Health Care Safety Net Amendments of 2002
(Public Law 107–251) shall apply to any obligation for which a discharge in bankruptcy has not
been granted before the date that is 31 days after
October 26, 2002.
(July 1, 1944, ch. 373, title III, § 338E, formerly
title VII, § 754, as added Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2286; amended
Pub. L. 95–83, title III, § 307(g), Aug. 1, 1977, 91
Stat. 391; renumbered § 338D and amended Pub.
L. 97–35, title XXVII, § 2709(a), (e)(1)–(4)(A), Aug.
13, 1981, 95 Stat. 908, 911; Pub. L. 97–414, § 8(g)(2),
Jan. 4, 1983, 96 Stat. 2061; renumbered § 338E and
amended Pub. L. 100–177, title II, §§ 201(2), 202(e),
title III, § 308(a), Dec. 1, 1987, 101 Stat. 992, 997,
1006; Pub. L. 100–203, title IV, § 4052(b), Dec. 22,
1987, 101 Stat. 1330–97; Pub. L. 100–360, title IV,
§ 411(f)(10)(B), July 1, 1988, 102 Stat. 780; Pub. L.
101–597, title II, § 203(a), Nov. 16, 1990, 104 Stat.
3027; Pub. L. 107–251, title III, § 313(a), Oct. 26,
2002, 116 Stat. 1651; Pub. L. 108–163, § 2(l)(1), Dec.
6, 2003, 117 Stat. 2022.)
REFERENCES IN TEXT
Section 234 of this title, referred to in subsecs. (b)(2)
and (d)(3)(B)(ii), was repealed by Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2281, effective Oct. 1,
1977.
2 See

References in Text note below.

Page 320

Section 254n of this title, referred to in subsec. (b)(2),
in the original referred to section 753, meaning section
753 of the Public Health Service Act, which was classified to section 294v of this title. Section 753 was redesignated section 338C of the Public Health Service Act
by Pub. L. 97–35, title XXVII, § 2709(a), Aug. 13, 1981, 95
Stat. 908, and was transferred to section 254n of this
title. Section 338C of the Public Health Service Act was
renumbered section 338D by Pub. L. 100–177, title II,
§ 201(2), Dec. 1, 1987, 101 Stat. 992.
Section 313(a)(4) of the Health Care Safety Net
Amendments of 2002, referred to in subsec. (f), is section
313(a)(4) of Pub. L. 107–251, which amended subsec.
(d)(3)(A) of this section. See 2002 Amendment note
below.
CODIFICATION
Section was formerly classified to section 294w of this
title prior to its renumbering by Pub. L. 97–35.
PRIOR PROVISIONS
A prior section 338E of act July 1, 1944, was renumbered section 338F by Pub. L. 100–177 and classified to
section 254p of this title, and subsequently renumbered
338G by Pub. L. 101–597.
AMENDMENTS
2003—Subsec. (c)(1). Pub. L. 108–163, § 2(l)(1)(A), realigned margins.
Subsec. (f). Pub. L. 108–163, § 2(l)(1)(B), added subsec.
(f).
2002—Subsec. (a)(1). Pub. L. 107–251, § 313(a)(1), substituted semicolon for comma at end of subpar. (A) and
‘‘; or’’ for comma at end of subpar. (B), struck out ‘‘or’’
at end of subpar. (C), and struck out subpar. (D) which
read as follows: ‘‘fails to accept payment, or instructs
the educational institution in which he is enrolled not
to accept payment, in whole or in part, of a scholarship
under such contract,’’.
Subsec. (b)(1)(A). Pub. L. 107–251, § 313(a)(2)(A)(ii)–(iv),
struck out ‘‘either’’ before ‘‘to begin’’, substituted
‘‘254n of this title,’’ for ‘‘254n of this title or’’, and inserted ‘‘or to complete a required residency as specified
in section 254l(f)(1)(B)(iv) of this title,’’ before ‘‘the
United States’’ the first time appearing.
Pub. L. 107–251, § 313(a)(2)(A)(i), made technical
amendment to reference in original act which appears
in text as reference to section 254p of this title.
Subsec. (b)(3). Pub. L. 107–251, § 313(a)(2)(B), added par.
(3).
Subsec. (c)(1). Pub. L. 107–251, § 313(a)(3)(A)(ii), added
subpars. (A) to (C) and concluding provisions and
struck out former subpars. (A) to (C) which related, respectively, to amounts to be recovered in the case of a
contract for a 2-year period of obligated service, in the
case of a contract for a period of obligated service of
greater than 2 years where the breach occurred before
the end of the first 2 years of such period, and in the
case of a contract for a period of obligated service of
greater than 2 years, where the breach occurred after
the first 2 years of such period.
Pub. L. 107–251, § 313(a)(3)(A)(i), in introductory provisions, made technical amendment to reference in original act which appears in text as reference to section
254p(d) of this title.
Subsec. (c)(2). Pub. L. 107–251, § 313(a)(3)(B), added par.
(2) and struck out former par. (2) which read as follows:
‘‘For purposes of paragraph (1), the term ‘unserved obligation penalty’ means the amount equal to the product
of the number of months of obligated service that were
not completed by an individual, multiplied by $1,000,
except that in any case in which the individual fails to
serve 1 year, the unserved obligation penalty shall be
equal to the full period of obligated service multiplied
by $1,000.’’
Subsec. (c)(3), (4). Pub. L. 107–251, § 313(a)(3)(B), (C), redesignated par. (4) as (3) and struck out former par. (3)
which read as follows: ‘‘The Secretary may waive, in
whole or in part, the rights of the United States to re-

Page 321

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cover amounts under this section in any case of extreme hardship or other good cause shown, as determined by the Secretary.’’
Subsec. (d)(3)(A). Pub. L. 107–251, § 313(a)(4), substituted ‘‘7-year period’’ for ‘‘five-year period’’.
Subsec. (e). Pub. L. 107–251, § 313(a)(5), added subsec.
(e).
1990—Subsec. (d)(3). Pub. L. 101–597 designated existing provision as subpar. (A) and added subpar. (B).
1988—Subsec. (b)(1)(B)(i). Pub. L. 100–360 made technical amendment to directory language of Pub. L.
100–203, see 1987 Amendment note below.
1987—Pub. L. 100–177, § 202(e)(6), inserted ‘‘or loan repayment contract’’ in section catchline.
Subsec. (a). Pub. L. 100–177, § 202(e)(1), designated existing provisions as par. (1), and former pars. (1) to (4)
as subpars. (A) to (D), respectively, and added par. (2).
Subsec. (b)(1). Pub. L. 100–177, § 202(e)(2), designated
existing provisions as subpar. (A), made technical
amendments to references to sections 254m, 254n, and
254p of this title wherever appearing to reflect renumbering of corresponding sections of original act, inserted ‘‘under section 254l of this title’’ after first reference to ‘‘service obligation’’ as the probable intent of
Congress, struck out at end ‘‘Any amount of damages
which the United States is entitled to recover under
this subsection shall, within the one year period beginning on the date of the breach of the written contract
(or such longer period beginning on such date as specified by the Secretary for good cause shown), be paid to
the United States.’’, and added subpar. (B).
Subsec. (b)(1)(B)(i). Pub. L. 100–203, as amended by
Pub. L. 100–360, inserted at end ‘‘Amounts not paid
within such period shall be subject to collection
through deductions in Medicare payments pursuant to
section 1395ccc of this title.’’
Subsec. (c). Pub. L. 100–177, § 202(e)(4), added subsec.
(c). Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 100–177, §§ 202(e)(3), (5), 308(a), redesignated subsec. (c) as (d), in pars. (1), (2), and (3), inserted ‘‘or the Loan Repayment Program (or a contract
thereunder’’, and in par. (3) inserted ‘‘, and only if the
bankruptcy court finds that nondischarge of the obligation would be unconscionable’’.
1983—Subsec. (b)(1). Pub. L. 97–414 substituted ‘‘section 254p(d)’’ for ‘‘section 254q(b)’’.
1981—Subsec. (a). Pub. L. 97–35, § 2709(e)(1), (2), redesignated subsec. (b) as (a) and, as so redesignated, in introductory text substituted ‘‘254l’’ for ‘‘294t’’ and added
par. (4). Former subsec. (a), which related to liability of
individual upon failure to accept payment, was struck
out.
Subsec. (b). Pub. L. 97–35, § 2709(e)(1), (3), redesignated
subsec. (c) as (b) and, as so redesignated, designated existing provisions as par. (1) and made numerous
changes to reflect renumbering of subpart sections, and
added par. (2). Former subsec. (b) redesignated (a).
Subsecs. (c), (d). Pub. L. 97–35, § 2709(e)(1), (4)(A), redesignated subsec. (d) as (c) and, as so redesignated, in
par. (2) inserted reference to partial or total waiver.
Former subsec. (c) redesignated (b).
1977—Subsec. (c). Pub. L. 95–83 substituted ‘‘ ‘φ’ is the
sum of the amounts paid under this subpart to or on behalf of the individual and the interest on such amounts
which would be payable if at the time the amounts
were paid they were loans’’ for ‘‘ ‘φ’ is the sum of the
amount paid under this subpart to or on behalf of the
individual and the interest on such amount which
would be payable if at the time it was paid it was a
loan’’.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendments by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107–251, title III, § 313(b), Oct. 26, 2002, 116 Stat.
1652, which provided that the amendment to this sec-

§ 254o–1

tion made by section 313(a)(4) of Pub. L. 107–251 was applicable to any obligation for which a discharge in
bankruptcy had not been granted before the date that
was 31 days after Oct. 26, 2002, was repealed by Pub. L.
108–163, §§ 2(l)(2), 3, Dec. 6, 2003, 117 Stat. 2023, effective
immediately after enactment of Pub. L. 107–251.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 203(b) of Pub. L. 101–597 provided that: ‘‘With
respect to any financial obligation of an individual
under subsection (f) of section 225 of the Public Health
Service Act [former section 234 of this title], as in effect prior to the repeal of such section by section
408(b)(1) of Public Law 94–484, the amendment made by
subsection (a) of this section [amending this section]
applies to any backruptcy [sic] proceeding in which discharge of such an obligation has not been granted before the date that is 31 days after the date of the enactment of this Act [Nov. 16, 1990].’’
EFFECTIVE DATE OF 1988 AMENDMENT
Except as specifically provided in section 411 of Pub.
L. 100–360, amendment by Pub. L. 100–360, as it relates
to a provision in the Omnibus Budget Reconciliation
Act of 1987, Pub. L. 100–203, effective as if included in
the enactment of that provision in Pub. L. 100–203, see
section 411(a) of Pub. L. 100–360, set out as a Reference
to OBRA; Effective Date note under section 106 of Title
1, General Provisions.
EFFECTIVE DATE
Section effective Oct. 1, 1977, see section 408(b)(1) of
Pub. L. 94–484, set out in part as a note under section
254l of this title.
EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION
See section 408(b)(2) of Pub. L. 94–484, set out as a
note under section 254l of this title.
SPECIAL REPAYMENT PROVISIONS
Section 204 of Pub. L. 100–177 provided that an individual who breached a written contract entered into
under section 254l of this title by failing either to begin
such individual’s service obligation in accordance with
section 254m of this title or to complete such service
obligation; or otherwise breached such a contract; and,
as of Nov. 1, 1987, was liable to United States under subsec. (b) of this section was to be relieved of liability to
United States under such section if the individual provided notice to Secretary and service in accordance
with a written contract with the Secretary that obligated the individual to provide service in accordance
with section and authorized Secretary to exclude an individual from relief from liability under this section for
reasons related to the individual’s professional competence or conduct.
EXISTING PROCEEDINGS
Section 308(b) of Pub. L. 100–177 provided that: ‘‘The
amendment made by subsection (a) [amending this section] applies to any bankruptcy proceeding in which
discharge of an obligation under section 338E(d)(3) of
the Public Health Service Act [subsec. (d)(3) of this section] (as redesignated by sections 201(2) and 202(e)(3) of
this Act) has not been granted before the date that is
31 days after the date of enactment of this Act [Dec. 1,
1987].’’

§ 254o–1. Fund regarding use of amounts recovered for contract breach to replace services
lost as result of breach
(a) Establishment of Fund
There is established in the Treasury of the
United States a fund to be known as the National Health Service Corps Member Replace-

§ 254p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment Fund (hereafter in this section referred to
as the ‘‘Fund’’). The Fund shall consist of such
amounts as may be appropriated under subsection (b) of this section to the Fund. Amounts
appropriated for the Fund shall remain available
until expended.
(b) Authorization of appropriations to Fund
For each fiscal year, there is authorized to be
appropriated to the Fund an amount equal to
the sum of—
(1) the amount collected during the preceding fiscal year by the Federal Government
pursuant to the liability of individuals under
section 254o of this title for the breach of contracts entered into under section 254l or 254l–1
of this title;
(2) the amount by which grants under section 254q–1 of this title have, for such preceding fiscal year, been reduced under subsection
(g)(2)(B) of such section; and
(3) the aggregate of the amount of interest
accruing during the preceding fiscal year on
obligations held in the Fund pursuant to subsection (d) of this section and the amount of
proceeds from the sale or redemption of such
obligations during such fiscal year.
(c) Use of Fund
(1) Payments to certain health facilities
Amounts in the Fund and available pursuant
to appropriations Act may, subject to paragraph (2), be expended by the Secretary to
make payments to any entity—
(A) to which a Corps member has been assigned under section 254f of this title; and
(B) that has a need for a health professional to provide primary health services as
a result of the Corps member having
breached the contract entered into under
section 254l or 254l–1 of this title by the individual.
(2) Purpose of payments
An entity receiving payments pursuant to
paragraph (1) may expend the payments to recruit and employ a health professional to provide primary health services to patients of the
entity, or to enter into a contract with such a
professional to provide the services to the patients.
(d) Investment
(1) In general
The Secretary of the Treasury shall invest
such amounts of the Fund as such Secretary
determines are not required to meet current
withdrawals from the Fund. Such investments
may be made only in interest-bearing obligations of the United States. For such purpose,
such obligations may be acquired on original
issue at the issue price, or by purchase of outstanding obligations at the market price.
(2) Sale of obligations
Any obligation acquired by the Fund may be
sold by the Secretary of the Treasury at the
market price.
(July 1, 1944, ch. 373, title III, § 338F, as added
Pub. L. 101–597, title II, § 204, Nov. 16, 1990, 104
Stat. 3027.)

Page 322

PRIOR PROVISIONS
A prior section 338F of act July 1, 1944, was renumbered section 338G by Pub. L. 101–597 and is classified to
section 254p of this title.
Another prior section 338F of act July 1, 1944, was renumbered section 338G by section 201(2) of Pub. L.
100–177 and classified to section 254q of this title, prior
to repeal by Pub. L. 100–177, title II, § 203, Dec. 1, 1987,
101 Stat. 999.

§ 254p. Special loans for former Corps members
to enter private practice
(a) Persons entitled; conditions
The Secretary may, out of appropriations authorized under section 254k of this title, make
one loan to a Corps member who has agreed in
writing—
(1) to engage in the private full-time clinical
practice of the profession of the member in a
health professional shortage area (designated
under section 254e of this title) for a period of
not less than 2 years which—
(A) in the case of a Corps member who is
required to complete a period of obligated
service under this subpart, begins not later
than 1 year after the date on which such individual completes such period of obligated
service; and
(B) in the case of an individual who is not
required to complete a period of obligated
service under this subpart, begins at such
time as the Secretary considers appropriate;
(2) to conduct such practice in accordance
with section 254n(b)(1) of this title; and
(3) to such additional conditions as the Secretary may require to carry out this section.
Such a loan shall be used to assist such individual in meeting the costs of beginning the practice of such individual’s profession in accordance with such agreement, including the costs of
acquiring equipment and renovating facilities
for use in providing health services, and of hiring nurses and other personnel to assist in providing health services. Such loan may not be
used for the purchase or construction of any
building.
(b) Amount of loan; maximum interest rate
(1) The amount of a loan under subsection (a)
of this section to an individual shall not exceed
$25,000.
(2) The interest rate for any such loan shall
not exceed an annual rate of 5 percent.
(c) Application for loan; submission and approval; interest rates and repayment terms
The Secretary may not make a loan under this
section unless an application therefor has been
submitted to, and approved by, the Secretary.
The Secretary shall, by regulation, set interest
rates and repayment terms for loans under this
section.
(d) Breach of agreement; notice; determination
of liability
If the Secretary determines that an individual
has breached a written agreement entered into
under subsection (a) of this section, he shall, as
soon as practicable after making such determination, notify the individual of such determination. If within 60 days after the date of giv-

Page 323

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing such notice, such individual is not practicing his profession in accordance with the agreement under such subsection and has not provided assurances satisfactory to the Secretary
that he will not knowingly violate such agreement again, the United States shall be entitled
to recover from such individual—
(1) in the case of an individual who has received a grant under this section (as in effect
prior to October 1, 1984), an amount determined under section 254o(b) of this title, except that in applying the formula contained in
such section ‘‘φ’’ shall be the sum of the
amount of the grant made under subsection (a)
of this section to such individual and the interest on such amount which would be payable
if at the time it was paid it was a loan bearing
interest at the maximum legal prevailing rate,
‘‘t’’ shall be the number of months that such
individual agreed to practice his profession
under such agreement, and ‘‘s’’ shall be the
number of months that such individual practices his profession in accordance with such
agreement; and
(2) in the case of an individual who has received a loan under this section, the full
amount of the principal and interest owed by
such individual under this section.
(July 1, 1944, ch. 373, title III, § 338G, formerly
title VII, § 755, as added Pub. L. 94–484, title IV,
§ 408(b)(1), Oct. 12, 1976, 90 Stat. 2287; renumbered
§ 338E and amended Pub. L. 97–35, title XXVII,
§ 2709(a), (f), Aug. 13, 1981, 95 Stat. 908, 911; Pub.
L. 97–414, § 8(g)(3), Jan. 4, 1983, 96 Stat. 2061; renumbered § 338F and amended Pub. L. 100–177,
title II, § 201(2), title III, § 309, Dec. 1, 1987, 101
Stat. 992, 1006; renumbered § 338G and amended
Pub. L. 101–597, title II, § 204, title IV,
§ 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3027, 3035.)
CODIFICATION
Section was formerly classified to section 294x of this
title prior to renumbering by Pub. L. 97–35.
PRIOR PROVISIONS
A prior section 338G of act July 1, 1944, was renumbered section 338H by Pub. L. 101–597 and is classified to
section 254q of this title.
Another prior section 338G of act July 1, 1944, was renumbered section 338I by section 201(1) of Pub. L.
100–177 and classified to section 254r of this title, prior
to repeal by Pub. L. 100–713, title I, § 104(b)(1), Nov. 23,
1988, 102 Stat. 4787.
Another prior section 338G of act July 1, 1944, was
classified to section 254q of this title prior to repeal by
Pub. L. 100–177, title II, § 203, Dec. 1, 1987, 101 Stat. 999.
AMENDMENTS
1990—Subsec. (a)(1). Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area
for reference to health manpower shortage area.
1987—Subsec. (a). Pub. L. 100–177, § 309(1), substituted
subsec. (a) consisting of pars. (1) to (3) for former subsec. (a) consisting of pars. (1) and (2).
Subsec. (b). Pub. L. 100–177, § 309(1), added subsec. (b)
and struck out former subsec. (b) which read as follows:
‘‘The amount of the grant or loan under subsection (a)
of this section to an individual shall be—
‘‘(1) $12,500 if the individual agrees to practice his
profession in accordance with the agreement for a period of at least one year, but less than two years; or
‘‘(2) $25,000 if the individual agrees to practice his
profession in accordance with the agreement for a period of at least two years.’’

§ 254q

Subsec. (c). Pub. L. 100–177, § 309(2), struck out ‘‘grant
or’’ before ‘‘loan’’ in first sentence.
Subsec. (d)(1). Pub. L. 100–177, § 309(3), substituted
‘‘under this section (as in effect prior to October 1,
1984)’’ for ‘‘under this section’’, and made technical
amendment to reference to section 254o(b) of this title
to reflect renumbering of corresponding section of
original act.
1983—Subsec. (d)(1). Pub. L. 97–414 substituted ‘‘section 254o(b)’’ for ‘‘section 254o(c)’’.
1981—Subsec. (a). Pub. L. 97–35, § 2709(f)(2)–(4), made
numerous changes to reflect renumbering of subpart
sections, among them inserting references to section
254k of this title and striking out references to section
294v of this title, and added applicability to loans.
Subsec. (b). Pub. L. 97–35, § 2709(f)(5), inserted applicability to loans.
Subsec. (c). Pub. L. 97–35, § 2709(f)(6), inserted provisions relating to loans and interest rates, etc.
Subsec. (d). Pub. L. 97–35, § 2709(f)(7), restructured and
revised criteria determining amount of liability of individual within 60 days after the date of notice instead of
within 120 days after the date of notice.
EFFECTIVE DATE
Section effective Oct. 1, 1977, see section 408(b)(1) of
Pub. L. 94–484, set out in part as a note under section
254l of this title.
EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION
See section 408(b)(2) of Pub. L. 94–484, set out as a
note under section 254l of this title.

§ 254q. Authorization of appropriations
(a) Authorization of appropriations
For the purpose of carrying out this section,1
there is authorized to be appropriated, out of
any funds in the Treasury not otherwise appropriated, the following:
(1) For fiscal year 2010, $320,461,632.
(2) For fiscal year 2011, $414,095,394.
(3) For fiscal year 2012, $535,087,442.
(4) For fiscal year 2013, $691,431,432.
(5) For fiscal year 2014, $893,456,433.
(6) For fiscal year 2015, $1,154,510,336.
(7) For fiscal year 2016, and each subsequent
fiscal year, the amount appropriated for the
preceding fiscal year adjusted by the product
of—
(A) one plus the average percentage increase in the costs of health professions education during the prior fiscal year; and
(B) one plus the average percentage change
in the number of individuals residing in
health professions shortage areas designated
under section 254f of this title during the
prior fiscal year, relative to the number of
individuals residing in such areas during the
previous fiscal year.
(b) Scholarships for new participants
Of the amounts appropriated under subsection
(a) of this section for a fiscal year, the Secretary
shall obligate not less than 10 percent for the
purpose of providing contracts for—
(1) scholarships under this subpart to individuals who have not previously received such
scholarships; or
(2) scholarships or loan repayments under
the Loan Repayment Program under section
1 So

in original. Probably should be ‘‘subpart,’’.

§ 254q–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

254l–1 of this title to individuals from disadvantaged backgrounds.
(c) Scholarships and loan repayments
With respect to certification as a nurse practitioner, nurse midwife, or physician assistant,
the Secretary shall, from amounts appropriated
under subsection (a) of this section for a fiscal
year, obligate not less than a total of 10 percent
for contracts for both scholarships under the
Scholarship Program under section 254l of this
title and loan repayments under the Loan Repayment Program under section 254l–1 of this
title to individuals who are entering the first
year of a course of study or program described
in section 254l(b)(1)(B) of this title that leads to
such a certification or individuals who are eligible for the loan repayment program as specified
in section 254l–1(b) of this title for a loan related
to such certification.
(July 1, 1944, ch. 373, title III, § 338H, formerly
§ 338G, as added Pub. L. 100–177, title II, § 203,
Dec. 1, 1987, 101 Stat. 999; renumbered § 338H and
amended Pub. L. 101–597, title II, §§ 204, 205, Nov.
16, 1990, 104 Stat. 3027, 3028; Pub. L. 107–251, title
III, § 314, Oct. 26, 2002, 116 Stat. 1652; Pub. L.
110–355, § 3(a)(2), Oct. 8, 2008, 122 Stat. 3993; Pub.
L. 111–148, title V, § 5207, Mar. 23, 2010, 124 Stat.
612.)
PRIOR PROVISIONS
A prior section 254q, act July 1, 1944, ch. 373, title III,
§ 338G, formerly title VII, § 756, as added Oct. 12, 1976,
Pub. L. 94–484, title IV, § 408(b)(1), 90 Stat. 2288; renumbered § 338F and amended Aug. 13, 1981, Pub. L. 97–35,
title XXVII, § 2709(a), (g), 95 Stat. 908, 912; renumbered
§ 338G, Dec. 1, 1987, Pub. L. 100–177, title II, § 201(2), 101
Stat. 992, authorized appropriations for fiscal years 1978
to 1987, prior to repeal by Pub. L. 100–177, § 203.
A prior section 338H of act July 1, 1944, was renumbered section 338I by Pub. L. 101–597 and is classified to
section 254q–1 of this title.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148 amended subsec. (a)
generally. Prior to amendment, subsec. (a) related to
authorization of appropriations for the purposes of carrying out this subpart as follows: for fiscal year 2008,
$131,500,000; for fiscal year 2009, $143,335,000; for fiscal
year 2010, $156,235,150; for fiscal year 2011, $170,296,310;
and for fiscal year 2012, $185,622,980.
2008—Subsec. (a). Pub. L. 110–355 substituted ‘‘appropriated—’’ for ‘‘appropriated $146,250,000 for fiscal year
2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.’’ and added pars. (1) to (5).
2002—Pub. L. 107–251 amended section generally. Prior
to amendment, section related to annual report to Congress, authorization of appropriations for fiscal years
1991 through 2000, and reservation of percentage of appropriated amounts for scholarships for new participants and for first-year study in certain fields.
1990—Subsec. (a). Pub. L. 101–597, § 205(a), substituted
‘‘March 1’’ for ‘‘January 20’’ and ‘‘5 fiscal years’’ for ‘‘3
fiscal years’’ wherever appearing.
Subsec. (b). Pub. L. 101–597, § 205(b), amended subsec.
(b) generally. Prior to amendment, subsec. (b) read as
follows: ‘‘There are authorized to be appropriated such
sums as may be necessary for scholarships and loan repayments under this subpart.’’

§ 254q–1. Grants to States for loan repayment
programs
(a) In general
(1) Authority for grants
The Secretary, acting through the Administrator of the Health Resources and Services

Page 324

Administration, may make grants to States
for the purpose of assisting the States in operating programs described in paragraph (2) in
order to provide for the increased availability
of primary health care services in health professional shortage areas. The National Advisory Council established under section 254j of
this title shall advise the Administrator regarding the program under this section.
(2) Loan repayment programs
The programs referred to in paragraph (1)
are, subject to subsection (c) of this section,
programs of entering into contracts under
which the State involved agrees to pay all or
part of the principal, interest, and related expenses of the educational loans of health professionals in consideration of the professionals
agreeing to provide primary health services in
health professional shortage areas.
(3) Direct administration by State agency
The Secretary may not make a grant under
paragraph (1) unless the State involved agrees
that the program operated with the grant will
be administered directly by a State agency.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under
subsection (a) of this section unless the State
agrees that, with respect to the costs of making payments on behalf of individuals under
contracts made pursuant to paragraph (2) of
such subsection, the State will make available
(directly or through donations from public or
private entities) non-Federal contributions in
cash toward such costs in an amount equal to
not less than $1 for each $1 of Federal funds
provided in the grant.
(2) Determination of amount of non-Federal
contribution
In determining the amount of non-Federal
contributions in cash that a State has provided pursuant to paragraph (1), the Secretary
may not include any amounts provided to the
State by the Federal Government.
(c) Coordination with Federal program
(1) Assignments for health professional shortage areas under Federal program
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that, in carrying out the program operated with the grant, the State will
assign health professionals participating in
the program only to public and nonprofit private entities located in and providing health
services in health professional shortage areas.
(2) Remedies for breach of contracts
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that the contracts provided by
the State pursuant to paragraph (2) of such
subsection will provide remedies for any
breach of the contracts by the health professionals involved.
(3) Limitation regarding contract inducements
(A) Except as provided in subparagraph (B),
the Secretary may not make a grant under

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

subsection (a) of this section unless the State
involved agrees that the contracts provided by
the State pursuant to paragraph (2) of such
subsection will not be provided on terms that
are more favorable to health professionals
than the most favorable terms that the Secretary is authorized to provide for contracts
under the Loan Repayment Program under
section 254l–1 of this title, including terms regarding—
(i) the annual amount of payments provided on behalf of the professionals regarding educational loans; and
(ii) the availability of remedies for any
breach of the contracts by the health professionals involved.
(B) With respect to the limitation established in subparagraph (A) regarding the annual amount of payments that may be provided to a health professional under a contract
provided by a State pursuant to subsection
(a)(2) of this section, such limitation shall not
apply with respect to a contract if—
(i) the excess of such annual payments
above the maximum amount authorized in
section 254l–1(g)(2)(A) of this title for annual
payments regarding contracts is paid solely
from non-Federal contributions under subsection (b) of this section; and
(ii) the contract provides that the health
professional involved will satisfy the requirement of obligated service under the
contract solely through the provision of primary health services in a health professional
shortage area that is receiving priority for
purposes of section 254f–1(a)(1) of this title
and that is authorized to receive assignments under section 254f of this title of individuals who are participating in the Scholarship Program under section 254l of this title.
(d) Restrictions on use of funds
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that the grant will not be expended—
(1) to conduct activities for which Federal
funds are expended—
(A) within the State to provide technical
or other nonfinancial assistance under subsection (f) of section 254c 1 of this title;
(B) under a memorandum of agreement entered into with the State under subsection
(h) of such section; or
(C) under a grant under section 254r of this
title; or
(2) for any purpose other than making payments on behalf of health professionals under
contracts entered into pursuant to subsection
(a)(2) of this section.
(e) Reports
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees—
(1) to submit to the Secretary such reports
regarding the States loan repayment program,
as are determined to be appropriate by the
Secretary; and
1 See

References in Text note below.

§ 254q–1

(2) to submit such a report not later than
January 10 of each fiscal year immediately following any fiscal year for which the State has
received such a grant.
(f) Requirement of application
The Secretary may not make a grant under
subsection (a) of this section unless an application for the grant is submitted to the Secretary
and the application is in such form, is made in
such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(g) Noncompliance
(1) In general
The Secretary may not make payments
under subsection (a) of this section to a State
for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately
preceding fiscal year, the State has complied
with each of the agreements made by the
State under this section.
(2) Reduction in grant relative to number of
breached contracts
(A) Before making a grant under subsection
(a) of this section to a State for a fiscal year,
the Secretary shall determine the number of
contracts provided by the State under paragraph (2) of such subsection with respect to
which there has been an initial breach by the
health professionals involved during the fiscal
year preceding the fiscal year for which the
State is applying to receive the grant.
(B) Subject to paragraph (3), in the case of a
State with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall
reduce the amount of a grant under subsection
(a) of this section to the State for the fiscal
year involved by an amount equal to the sum
of the expenditures of Federal funds made regarding the contracts involved and an amount
representing interest on the amount of such
expenditures, determined with respect to each
contract on the basis of the maximum legal
rate prevailing for loans made during the time
amounts were paid under the contract, as determined by the Treasurer of the United
States.
(3) Waiver regarding reduction in grant
The Secretary may waive the requirement
established in paragraph (2)(B) with respect to
the initial breach of a contract if the Secretary determines that such breach by the
health professional involved was attributable
solely to the professional having a serious illness.
(h) ‘‘State’’ defined
For purposes of this section, the term ‘‘State’’
means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the
United States Virgin Islands, Guam, American
Samoa, Palau, the Marshall Islands, and the
Commonwealth of the Northern Mariana Islands.
(i) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there are authorized

§ 254r

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to be appropriated $12,000,000 for fiscal year
2008, and such sums as may be necessary for
each of fiscal years 2009 through 2012.
(2) Availability
Amounts appropriated under paragraph (1)
shall remain available until expended.
(j) Public health loan repayment
(1) In general
The Secretary may award grants to States
for the purpose of assisting such States in operating loan repayment programs under which
such States enter into contracts to repay all
or part of the eligible loans borrowed by, or on
behalf of, individuals who agree to serve in
State, local, or tribal health departments that
serve health professional shortage areas or
other areas at risk of a public health emergency, as designated by the Secretary.
(2) Loans eligible for repayment
To be eligible for repayment under this subsection, a loan shall be a loan made, insured,
or guaranteed by the Federal Government that
is borrowed by, or on behalf of, an individual
to pay the cost of attendance for a program of
education leading to a degree appropriate for
serving in a State, local, or tribal health department as determined by the Secretary and
the chief executive officer of the State in
which the grant is administered, at an institution of higher education (as defined in section
1002 of title 20), including principal, interest,
and related expenses on such loan.
(3) Applicability of existing requirements
With respect to awards made under paragraph (1)—
(A) the requirements of subsections (b), (f),
and (g) shall apply to such awards; and
(B) the requirements of subsection (c) shall
apply to such awards except that with respect to paragraph (1) of such subsection, the
State involved may assign an individual
only to public and nonprofit private entities
that serve health professional shortage areas
or areas at risk of a public health emergency, as determined by the Secretary.
(4) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection, such sums as may
be necessary for each of fiscal years 2007
through 2010.
(July 1, 1944, ch. 373, title III, § 338I, formerly
§ 338H, as added Pub. L. 100–177, title II, § 203,
Dec. 1, 1987, 101 Stat. 999; renumbered § 338I and
amended Pub. L. 101–597, title II, § 204, title III,
§ 301, title IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat.
3027, 3029, 3035; Pub. L. 105–392, title IV, § 408,
Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107–251, title
III, § 315, Oct. 26, 2002, 116 Stat. 1653; Pub. L.
109–417, title II, § 203(b), Dec. 19, 2006, 120 Stat.
2849; Pub. L. 110–355, § 3(e), Oct. 8, 2008, 122 Stat.
3994.)
REFERENCES IN TEXT
Section 254c of this title, referred to in subsec.
(d)(1)(A), was in the original a reference to section 330,
meaning section 330 of act July 1, 1944, which was omitted in the general amendment of subpart I (§ 254b et

Page 326

seq.) of this part by Pub. L. 104–299, § 2, Oct. 11, 1996, 110
Stat. 3626. Sections 2 and 3(a) of Pub. L. 104–299 enacted
new sections 330 and 330A of act July 1, 1944, which are
classified, respectively, to sections 254b and 254c of this
title.
PRIOR PROVISIONS
A prior section 338I of act July 1, 1944, was classified
to section 254r of this title prior to repeal by Pub. L.
100–713, title I, § 104(b)(1), Nov. 23, 1988, 102 Stat. 4787.
AMENDMENTS
2008—Subsec. (h). Pub. L. 110–355, § 3(e)(1), substituted
‘‘50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the Northern Mariana
Islands’’ for ‘‘several States’’.
Subsec. (i)(1). Pub. L. 110–355, § 3(e)(2), substituted
‘‘2008, and such sums as may be necessary for each of
fiscal years 2009 through 2012.’’ for ‘‘2002 and such sums
as may be necessary for each of fiscal years 2003
through 2006.’’
2006—Subsec. (j). Pub. L. 109–417 added subsec. (j).
2002—Subsec. (a)(1). Pub. L. 107–251, § 315(1), added par.
(1) and struck out heading and text of former par. (1).
Text read as follows: ‘‘The Secretary, acting through
the Administrator of the Health Resources and Services Administration, may make grants to States for the
purpose of assisting the States in operating programs
described in paragraph (2) in order to provide for the increased availability of primary health services in
health professional shortage areas.’’
Subsec. (e)(1). Pub. L. 107–251, § 315(2), added par. (1)
and struck out former par. (1) which read as follows:
‘‘to submit to the Secretary reports providing the same
types of information regarding the program operated
pursuant to such subsection as reports submitted pursuant to subsection (i) of section 254l–1 of this title provide regarding the Loan Repayment Program under
such section; and’’.
Subsec. (i)(1). Pub. L. 107–251, § 315(3), added par. (1)
and struck out heading and text of former par. (1). Text
read as follows: ‘‘For the purpose of making grants
under subsection (a) of this section, there is authorized
to be appropriated $10,000,000 for each of the fiscal years
1991 through 1995, and such sums as may be necessary
for each of the fiscal years 1998 through 2002.’’
1998—Subsec. (i)(1). Pub. L. 105–392 inserted ‘‘, and
such sums as may be necessary for each of the fiscal
years 1998 through 2002’’ before period at end.
1990—Pub. L. 101–597, § 401(b)[(a)], substituted reference to health professional shortage area for reference to health manpower shortage area wherever appearing in subsecs. (a)(1), (2) and (c)(1), (3)(B)(ii).
Pub. L. 101–597, § 301, amended section generally, substituting present provisions for provisions which related to: in subsec. (a), grants; in subsec. (b), applications;
in subsec. (c), Federal share; and in subsec. (d), authorization of appropriations.

§ 254r. Grants to States for operation of offices of
rural health
(a) In general
The Secretary, acting through the Director of
the Office of Rural Health Policy (established in
section 912 of this title), may make grants to
States for the purpose of improving health care
in rural areas through the operation of State offices of rural health.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees, with respect to the costs to be
incurred by the State in carrying out the pur-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

pose described in such subsection, to provide
non-Federal contributions toward such costs
in an amount equal to—
(A) for the first fiscal year of payments
under the grant, not less than $1 for each $3
of Federal funds provided in the grant;
(B) for any second fiscal year of such payments, not less than $1 for each $1 of Federal
funds provided in the grant; and
(C) for any third fiscal year of such payments, not less than $3 for each $1 of Federal
funds provided in the grant.
(2) Determination of amount of non-Federal
contribution
(A) Subject to subparagraph (B), non-Federal
contributions required in paragraph (1) may be
in cash or in kind, fairly evaluated, including
plant, equipment, or services. Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent
by the Federal Government, may not be included in determining the amount of such nonFederal contributions.
(B) The Secretary may not make a grant
under subsection (a) of this section unless the
State involved agrees that—
(i) for the first fiscal year of payments
under the grant, 100 percent or less of the
non-Federal contributions required in paragraph (1) will be provided in the form of inkind contributions;
(ii) for any second fiscal year of such payments, not more than 50 percent of such nonFederal contributions will be provided in the
form of in-kind contributions; and
(iii) for any third fiscal year of such payments, such non-Federal contributions will
be provided solely in the form of cash.
(c) Certain required activities
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that activities carried out by an
office operated pursuant to such subsection will
include—
(1) establishing and maintaining within the
State a clearinghouse for collecting and disseminating information on—
(A) rural health care issues;
(B) research findings relating to rural
health care; and
(C) innovative approaches to the delivery
of health care in rural areas;
(2) coordinating the activities carried out in
the State that relate to rural health care, including providing coordination for the purpose
of avoiding redundancy in such activities; and
(3) identifying Federal and State programs
regarding rural health, and providing technical assistance to public and nonprofit private entities regarding participation in such
programs.
(d) Requirement regarding annual budget for office
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that, for any fiscal year for
which the State receives such a grant, the office
operated pursuant to subsection (a) of this section will be provided with an annual budget of
not less than $50,000.

§ 254r

(e) Certain uses of funds
(1) Restrictions
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that—
(A) if research with respect to rural health
is conducted pursuant to the grant, not more
than 10 percent of the grant will be expended
for such research; and
(B) the grant will not be expended—
(i) to provide health care (including providing cash payments regarding such
care);
(ii) to conduct activities for which Federal funds are expended—
(I) within the State to provide technical and other nonfinancial assistance
under subsection (f) of section 254c 1 of
this title;
(II) under a memorandum of agreement
entered into with the State under subsection (h) of such section; or
(III) under a grant under section 254q–1
of this title;
(iii) to purchase medical equipment, to
purchase ambulances, aircraft, or other vehicles, or to purchase major communications equipment;
(iv) to purchase or improve real property; or
(v) to carry out any activity regarding a
certificate of need.
(2) Authorities
Activities for which a State may expend a
grant under subsection (a) of this section include—
(A) paying the costs of establishing an office of rural health for purposes of subsection (a) of this section;
(B) subject to paragraph (1)(B)(ii)(III), paying the costs of any activity carried out with
respect to recruiting and retaining health
professionals to serve in rural areas of the
State; and
(C) providing grants and contracts to public and nonprofit private entities to carry
out activities authorized in this section.
(f) Reports
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees—
(1) to submit to the Secretary reports containing such information as the Secretary
may require regarding activities carried out
under this section by the State; and
(2) to submit such a report not later than
January 10 of each fiscal year immediately following any fiscal year for which the State has
received such a grant.
(g) Requirement of application
The Secretary may not make a grant under
subsection (a) of this section unless an application for the grant is submitted to the Secretary
and the application is in such form, is made in
such manner, and contains such agreements, assurances, and information as the Secretary de1 See

References in Text note below.

§ 254s

TITLE 42—THE PUBLIC HEALTH AND WELFARE

termines to be necessary to carry out such subsection.
(h) Noncompliance
The Secretary may not make payments under
subsection (a) of this section to a State for any
fiscal year subsequent to the first fiscal year of
such payments unless the Secretary determines
that, for the immediately preceding fiscal year,
the State has complied with each of the agreements made by the State under this section.
(i) ‘‘State’’ defined
For purposes of this section, the term ‘‘State’’
means each of the several States.
(j) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there are authorized
to be appropriated $3,000,000 for fiscal year
1991, $4,000,000 for fiscal year 1992, $3,000,000 for
fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1998 through
2002.
(2) Availability
Amounts appropriated under paragraph (1)
shall remain available until expended.
(k) Termination of program
No grant may be made under this section after
the aggregate amounts appropriated under subsection (j)(1) of this section are equal to
$36,000,000.
(July 1, 1944, ch. 373, title III, § 338J, as added
Pub. L. 101–597, title III, § 302, Nov. 16, 1990, 104
Stat. 3032; amended Pub. L. 105–392, title III,
§ 301, Nov. 13, 1998, 112 Stat. 3585.)
REFERENCES IN TEXT
Section 254c of this title, referred to in subsec.
(e)(1)(B)(ii)(I), was in the original a reference to section
330, meaning section 330 of act July 1, 1944, which was
omitted in the general amendment of subpart I (§ 254b
et seq.) of this part by Pub. L. 104–299, § 2, Oct. 11, 1996,
110 Stat. 3626. Sections 2 and 3(a) of Pub. L. 104–299 enacted new sections 330 and 330A of act July 1, 1944,
which are classified, respectively, to sections 254b and
254c of this title.
PRIOR PROVISIONS
A prior section 254r, act July 1, 1944, ch. 373, title III,
§ 338I, formerly title VII, § 757, as added Aug. 1, 1977,
Pub. L. 95–83, title III, § 307(n)(1), 91 Stat. 392; amended
Dec. 17, 1980, Pub. L. 96–537, § 3(d), 94 Stat. 3174; renumbered § 338G, Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2709(a), 95 Stat. 908; Oct. 30, 1984, Pub. L. 98–551, § 3, 98
Stat. 2817; renumbered § 338I, Dec. 1, 1987, Pub. L.
100–177, title II, § 201(1), 101 Stat. 992; Nov. 4, 1988, Pub.
L. 100–607, title VI, § 629(a)(3), 102 Stat. 3146, which related to Indian Health Scholarships and was classified
to section 294y–1 of this title prior to renumbering by
Pub. L. 97–35, was repealed by Pub. L. 100–713, title I,
§ 104(b)(1), Nov. 23, 1988, 102 Stat. 4787. For provisions
continuing scholarships provided on or before Nov. 23,
1988, see section 104(b)(2) of Pub. L. 100–713.
A prior section 338J of act July 1, 1944, was renumbered section 338K by Pub. L. 101–597 and is classified to
section 254s of this title.

Page 328

Subsec. (j)(1). Pub. L. 105–392, § 301(2), struck out
‘‘and’’ after ‘‘1992,’’ and inserted before period at end
‘‘, and such sums as may be necessary for each of the
fiscal years 1998 through 2002’’.
Subsec. (k). Pub. L. 105–392, § 301(3), substituted
‘‘$36,000,000’’ for ‘‘$10,000,000’’.
COMMUNICATIONS FOR RURAL HEALTH PROVIDERS
Pub. L. 102–538, title I, § 154, formerly § 134, Oct. 27,
1992, 106 Stat. 3541, renumbered § 154 by Pub. L. 103–66,
title VI, § 6001(a)(2), Aug. 10, 1993, 107 Stat. 379, directed
Secretary of Commerce, in conjunction with Secretary
of Health and Human Services, to establish an advisory
panel to develop recommendations for the improvement of rural health care through the collection of information needed by providers and the improvement in
the use of communications to disseminate such information and, not later than 1 year after establishment
of Panel to prepare and submit to Congress a report
summarizing the recommendations made by the Panel.
Similar provisions were contained in Pub. L. 101–555,
§ 3, Nov. 15, 1990, 104 Stat. 2760.

§ 254s. Native Hawaiian Health Scholarships
(a) Eligibility
Subject to the availability of funds appropriated under the authority of subsection (d) of
this section, the Secretary shall provide funds
to Papa Ola Lokahi for the purpose of providing
scholarship assistance to students who—
(1) meet the requirements of section 254l(b)
of this title, and
(2) are Native Hawaiians.
(b) Terms and conditions
(1) The scholarship assistance provided under
subsection (a) of this section shall be provided
under the same terms and subject to the same
conditions, regulations, and rules that apply to
scholarship assistance provided under section
254l of this title.
(2) The Native Hawaiian Health Scholarship
program shall not be administered by or through
the Indian Health Service.
(c) ‘‘Native Hawaiian’’ defined
For purposes of this section, the term ‘‘Native
Hawaiian’’ means any individual who is—
(1) a citizen of the United States,
(2) a resident of the State of Hawaii, and
(3) a descendant of the aboriginal people,
who prior to 1778, occupied and exercised sovereignty in the area that now constitutes the
State of Hawaii, as evidenced by—
(A) genealogical records,
(B) Kupuna (elders) or Kama’aina (longterm community residents) verification, or
(C) birth records of the State of Hawaii.
(d) Authorization of appropriations
There are authorized to be appropriated
$1,800,000 for each of the fiscal years 1990, 1991,
and 1992 for the purpose of funding the scholarship assistance provided under subsection (a) of
this section.

AMENDMENTS

(July 1, 1944, ch. 373, title III, § 338K, formerly
§ 338J, as added Pub. L. 100–713, title I, § 106, Nov.
23, 1988, 102 Stat. 4787; renumbered § 338K, Pub. L.
101–597, title III, § 302, Nov. 16, 1990, 104 Stat. 3032;
amended Pub. L. 101–644, title IV, § 401, Nov. 29,
1990, 104 Stat. 4668; Pub. L. 107–116, title V,
§ 514(b), Jan. 10, 2002, 115 Stat. 2220.)

1998—Subsec. (b)(1). Pub. L. 105–392, § 301(1), struck
out ‘‘in cash’’ after ‘‘contributions’’ in introductory
provisions.

2002—Subsec. (a). Pub. L. 107–116, which directed the
amendment of subsec. (a) by substituting ‘‘Papa Ola

AMENDMENTS

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Lokahi’’ for ‘‘Kamehameha School/Bishop Estate’’, was
executed by making the substitution for ‘‘Kamehameha
Schools/Bishop Estate’’ to reflect the probable intent of
Congress.
1990—Subsec. (a). Pub. L. 101–644, which directed the
general amendment of subsec. (a) of section 338J of the
Public Health Service Act, was executed to subsec. (a)
of this section, to reflect the probable intent of Congress and the intervening renumbering of section 338J
as 338K by Pub. L. 101–597. Prior to amendment, subsec.
(a) read as follows: ‘‘Subject to the availability of funds
appropriated under the authority of subsection (d) of
this section, the Secretary shall provide scholarship assistance, pursuant to a contract with the Kamehameha
Schools/Bishop Estate, to students who—
‘‘(1) meet the requirements of section 254l(b) of this
title, and
‘‘(2) are Native Hawaiians.’’

§ 254t. Demonstration project
(a) Program authorized
The Secretary shall establish a demonstration
project to provide for the participation of individuals who are chiropractic doctors or pharmacists in the Loan Repayment Program described in section 254l–1 of this title.
(b) Procedure
An individual that receives assistance under
this section with regard to the program described in section 254l–1 of this title shall comply with all rules and requirements described in
such section (other than subparagraphs (A) and
(B) of section 254l–1(b)(1) of this title) in order to
receive assistance under this section.
(c) Limitations
(1) In general
The demonstration project described in this
section shall provide for the participation of
individuals who shall provide services in rural
and urban areas.
(2) Availability of other health professionals
The Secretary may not assign an individual
receiving assistance under this section to provide obligated service at a site unless—
(A) the Secretary has assigned a physician
(as defined in section 1395x(r) of this title) or
other health professional licensed to prescribe drugs to provide obligated service at
such site under section 254m or 254n of this
title; and
(B) such physician or other health professional will provide obligated service at such
site concurrently with the individual receiving assistance under this section.
(3) Rules of construction
(A) Supervision of individuals
Nothing in this section shall be construed
to require or imply that a physician or other
health professional licensed to prescribe
drugs must supervise an individual receiving
assistance under the demonstration project
under this section, with respect to such
project.
(B) Licensure of health professionals
Nothing in this section shall be construed
to supersede State law regarding licensure of
health professionals.
(d) Designations
The demonstration project described in this
section, and any providers who are selected to

§ 254t

participate in such project, shall not be considered by the Secretary in the designation of a
health professional shortage area under section
254e of this title during fiscal years 2002 through
2004.
(e) Rule of construction
This section shall not be construed to require
any State to participate in the project described
in this section.
(f) Report
(1) In general
The Secretary shall evaluate the participation of individuals in the demonstration
projects under this section and prepare and
submit a report containing the information
described in paragraph (2) to—
(A) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(B) the Subcommittee on Labor, Health
and Human Services, and Education of the
Committee on Appropriations of the Senate;
(C) the Committee on Energy and Commerce of the House of Representatives; and
(D) the Subcommittee on Labor, Health
and Human Services, and Education of the
Committee on Appropriations of the House
of Representatives.
(2) Content
The report described in paragraph (1) shall
detail—
(A) the manner in which the demonstration project described in this section has affected access to primary care services, patient satisfaction, quality of care, and
health care services provided for traditionally underserved populations;
(B) how the participation of chiropractic
doctors and pharmacists in the Loan Repayment Program might affect the designation
of health professional shortage areas; and
(C) whether adding chiropractic doctors
and pharmacists as permanent members of
the National Health Service Corps would be
feasible and would enhance the effectiveness
of the National Health Service Corps.
(g) Authorization of appropriations
(1) In general
There are authorized to be appropriated to
carry out this section, such sums as may be
necessary for fiscal years 2002 through 2004.
(2) Fiscal year 2005
If the Secretary determines and certifies to
Congress by not later than September 30, 2004,
that the number of individuals participating
in the demonstration project established
under this section is insufficient for purposes
of performing the evaluation described in subsection (f)(1) of this section, the authorization
of appropriations under paragraph (1) shall be
extended to include fiscal year 2005.
(July 1, 1944, ch. 373, title III, § 338L, as added
Pub. L. 107–251, title III, § 317, Oct. 26, 2002, 116
Stat. 1653.)
PRIOR PROVISIONS
A prior section 254t, act July 1, 1944, ch. 373, title III,
§ 338L, as added Pub. L. 101–527, § 8, Nov. 6, 1990, 104 Stat.

§ 254u

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2328, related to demonstration grants to States for
community scholarship programs, prior to repeal by
Pub. L. 107–251, title III, § 316, Oct. 26, 2002, 116 Stat.
1653.

§ 254u. Public health departments
(a) In general
To the extent that funds are appropriated
under subsection (e), the Secretary shall establish a demonstration project to provide for the
participation of individuals who are eligible for
the Loan Repayment Program described in section 254l–1 of this title and who agree to complete their service obligation in a State health
department that provides a significant amount
of service to health professional shortage areas
or areas at risk of a public health emergency, as
determined by the Secretary, or in a local or
tribal health department that serves a health
professional shortage area or an area at risk of
a public health emergency.
(b) Procedure
To be eligible to receive assistance under subsection (a), with respect to the program described in section 254l–1 of this title, an individual shall—
(1) comply with all rules and requirements
described in such section (other than section
254l–1(f)(1)(B)(iv) of this title); and
(2) agree to serve for a time period equal to
2 years, or such longer period as the individual
may agree to, in a State, local, or tribal
health department, described in subsection (a).
(c) Designations
The demonstration project described in subsection (a), and any healthcare providers who
are selected to participate in such project, shall
not be considered by the Secretary in the designation of health professional shortage areas
under section 254e of this title during fiscal
years 2007 through 2010.
(d) Report
Not later than 3 years after December 19, 2006,
the Secretary shall submit a report to the relevant committees of Congress that evaluates
the participation of individuals in the demonstration project under subsection (a), the impact of such participation on State, local, and
tribal health departments, and the benefit and
feasibility of permanently allowing such placements in the Loan Repayment Program.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, such sums as may be necessary for each of fiscal years 2007 through 2010.
(July 1, 1944, ch. 373, title III, § 338M, as added
Pub. L. 109–417, title II, § 203(a), Dec. 19, 2006, 120
Stat. 2848.)
SUBPART IV—HOME HEALTH SERVICES

AMENDMENTS
1987—Pub. L. 100–177, title II, § 202(f)(1), Dec. 1, 1987,
101 Stat. 999, substituted ‘‘IV’’ for ‘‘III’’ as subpart designation.
1983—Pub. L. 97–414, § 6(a), Jan. 4, 1983, 96 Stat. 2057,
added heading ‘‘Subpart III—Home Health Services’’.
1978—Pub. L. 95–626, title I, § 105(b), title II, § 207(a),
Nov. 10, 1978, 92 Stat. 3560, 3585, struck out heading

Page 330

‘‘Part D—Lepers’’ and added heading ‘‘Subpart III—
Home Health Services’’.

§ 255. Home health services
(a) Purpose; authorization of grants and loans;
considerations; conditions on loans; appropriations
(1) For the purpose of encouraging the establishment and initial operation of home health
programs to provide home health services in
areas in which such services are inadequate or
not readily accessible, the Secretary may, in accordance with the provisions of this section,
make grants to public and nonprofit private entities and loans to proprietary entities to meet
the initial costs of establishing and operating
such home health programs. Such grants and
loans may include funds to provide training for
paraprofessionals (including homemaker home
health aides) to provide home health services.
(2) In making grants and loans under this subsection, the Secretary shall—
(A) consider the relative needs of the several
States for home health services;
(B) give preference to areas in which a high
percentage of the population proposed to be
served is composed of individuals who are elderly, medically indigent, or disabled; and
(C) give special consideration to areas with
inadequate means of transportation to obtain
necessary health services.
(3)(A) No loan may be made to a proprietary
entity under this section unless the application
of such entity for such loan contains assurances
satisfactory to the Secretary that—
(i) at the time the application is made the
entity is fiscally sound;
(ii) the entity is unable to secure a loan for
the project for which the application is submitted from non-Federal lenders at the rate of
interest prevailing in the area in which the entity is located; and
(iii) during the period of the loan, such entity will remain fiscally sound.
(B) Loans under this section shall be made at
an interest rate comparable to the rate of interest prevailing on the date the loan is made with
respect to the marketable obligations of the
United States of comparable maturities, adjusted to provide for administrative costs.
(4) Applications for grants and loans under
this subsection shall be in such form and contain such information as the Secretary shall
prescribe.
(5) There are authorized to be appropriated for
grants and loans under this subsection $5,000,000
for each of the fiscal years ending on September
30, 1983, September 30, 1984, September 30, 1985,
September 30, 1986, and September 30, 1987.
(b) Grants and contracts for training programs
for paraprofessionals; considerations; applications; appropriations
(1) The Secretary may make grants to and
enter into contracts with public and private entities to assist them in developing appropriate
training programs for paraprofessionals (including homemaker home health aides) to provide
home health services.
(2) Any program established with a grant or
contract under this subsection to train homemaker home health aides shall—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) extend for at least forty hours, and consist of classroom instruction and at least
twenty hours (in the aggregate) of supervised
clinical instruction directed toward preparing
students to deliver home health services;
(B) be carried out under appropriate professional supervision and be designed to train
students to maintain or enhance the personal
care of an individual in his home in a manner
which promotes the functional independence
of the individual; and
(C) include training in—
(i) personal care services designed to assist
an individual in the activities of daily living
such as bathing, exercising, personal grooming, and getting in and out of bed; and
(ii) household care services such as maintaining a safe living environment, light
housekeeping, and assisting in providing
good nutrition (by the purchasing and preparation of food).
(3) In making grants and entering into contracts under this subsection, special consideration shall be given to entities which establish
or will establish programs to provide training
for persons fifty years of age and older who wish
to become paraprofessionals (including homemaker home health aides) to provide home
health services.
(4) Applications for grants and contracts under
this subsection shall be in such form and contain such information as the Secretary shall
prescribe.
(5) There are authorized to be appropriated for
grants and contracts under this subsection
$2,000,000 for each of the fiscal years ending September 30, 1983, September 30, 1984, September
30, 1985, September 30, 1986, and September 30,
1987.
(c) Report to Congress with respect to grants
and loans and training of personnel
The Secretary shall report to the Committee
on Labor and Human Resources of the Senate
and the Committee on Energy and Commerce of
the House of Representatives on or before January 1, 1984, with respect to—
(1) the impact of grants made and contracts
entered into under subsections (a) and (b) of
this section (as such subsections were in effect
prior to October 1, 1981);
(2) the need to continue grants and loans
under subsections (a) and (b) of this section (as
such subsections are in effect on the day after
January 4, 1983); and
(3) the extent to which standards have been
applied to the training of personnel who provide home health services.
(d) ‘‘Home health services’’ defined
For purposes of this section, the term ‘‘home
health services’’ has the meaning prescribed for
the term by section 1395x(m) of this title.
(July 1, 1944, ch. 373, title III, § 339, as added Pub.
L. 97–414, § 6(a), Jan. 4, 1983, 96 Stat. 2057; amended Pub. L. 98–555, § 6, Oct. 30, 1984, 98 Stat. 2856.)
REFERENCES IN TEXT
Subsections (a) and (b) of this section (as such subsections were in effect prior to October 1, 1981), referred
to in subsec. (c)(1), mean subsections (a) and (b) of sec-

§ 255

tion 255 of this title prior to repeal of section 255 by
Pub. L. 97–35, title IX, § 902(b), Aug. 13, 1981, 95 Stat. 559,
effective Oct. 1, 1981.
PRIOR PROVISIONS
A prior section 255, act July 1, 1944, ch. 373, title III,
§ 339, as added Nov. 10, 1978, Pub. L. 95–626, title II,
§ 207(a), 92 Stat. 3585, related to grant authority, etc.,
for home health services, prior to repeal by Pub. L.
97–35, title IX, § 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561,
eff. Oct. 1, 1981.
Another prior section 339 of act July 1, 1944, ch. 373,
title III, formerly § 331, 58 Stat. 698; June 25, 1948, ch.
654, § 4, 62 Stat. 1018; June 25, 1952, ch. 460, 66 Stat. 157;
July 12, 1960, Pub. L. 86–624, § 29(b), 74 Stat. 419; renumbered § 339, Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 407(b)(2), 90 Stat. 2268, which related to reception of
persons suffering from leprosy in any hospital, was renumbered section 320 of act July 1, 1944, and transferred
to section 247e of this title.
AMENDMENTS
1984—Subsecs. (a)(5), (b)(5). Pub. L. 98–555 inserted
provisions authorizing appropriations for fiscal years
ending Sept. 30, 1985, 1986, and 1987.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
REPORT TO CONGRESS CONCERNING RESULTS OF STUDIES
EVALUATING HOME AND COMMUNITY BASED
HEALTH SERVICES; STUDIES OF REIMBURSEMENT
METHODOLOGIES; INVESTIGATION OF FRAUD; DEMONSTRATION PROJECTS; HOME HEALTH SERVICES, DEFINED

Section 6(b)–(f) of Pub. L. 97–414 directed Secretary of
Health and Human Services to report results of studies
evaluating home and community based health services,
and any recommendations for legislative action which
might improve the provision of such services, to Congress prior to Jan. 1, 1985, to compile and analyze results of significant public or private studies relating to
reimbursement methodologies for home health services
and to report recommendations to Congress within 180
days after Jan. 4, 1983, to investigate methods available
to stem medicare and medicaid fraud and abuse and extent to which such methods are applied and to report
results to Congress within 18 months of Jan. 4, 1983, and
to develop and carry out demonstration projects commencing no later than Jan. 1, 1984, to test methods for
identifying patients at risk of institutionalization who
could be treated more cost-effectively with home
health services, and to test alternative reimbursement
methodologies for home health agencies in order to determine most cost-effective way of providing home
health services, and to report to Congress with regard
to the demonstrations no later than Jan. 1, 1985; and
defined ‘‘home health services’’ for purposes of this section.
SUBPART V—HEALTHY COMMUNITIES ACCESS
PROGRAM

PRIOR PROVISIONS
A prior subpart VI, consisting of section 256a, related
to health services for residents of public housing, prior

§ 256

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to repeal by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996, 110
Stat. 3645.

§ 256. Grants to strengthen the effectiveness, efficiency, and coordination of services for the
uninsured and underinsured
(a) In general
The Secretary may award grants to eligible
entities to assist in the development of integrated health care delivery systems to serve
communities of individuals who are uninsured
and individuals who are underinsured—
(1) to improve the efficiency of, and coordination among, the providers providing services
through such systems;
(2) to assist communities in developing programs targeted toward preventing and managing chronic diseases; and
(3) to expand and enhance the services provided through such systems.
(b) Eligible entities
To be eligible to receive a grant under this
section, an entity shall be an entity that—
(1) represents a consortium—
(A) whose principal purpose is to provide a
broad range of coordinated health care services for a community defined in the entity’s
grant application as described in paragraph
(2); and
(B) that includes at least one of each of
the following providers that serve the community (unless such provider does not exist
within the community, declines or refuses to
participate, or places unreasonable conditions on their participation)—
(i) a Federally qualified health center (as
defined in section 1395x(aa) of this title);
(ii) a hospital with a low-income utilization rate (as defined in section 1396r–4(b)(3)
of this title), that is greater than 25 percent;
(iii) a public health department; and
(iv) an interested public or private sector
health care provider or an organization
that has traditionally served the medically uninsured and underserved; and
(2) submits to the Secretary an application,
in such form and manner as the Secretary
shall prescribe, that—
(A) defines a community or geographic
area of uninsured and underinsured individuals;
(B) identifies the providers who will participate in the consortium’s program under
the grant, and specifies each provider’s contribution to the care of uninsured and underinsured individuals in the community, including the volume of care the provider provides to beneficiaries under the medicare,
medicaid, and State child health insurance
programs and to patients who pay privately
for services;
(C) describes the activities that the applicant and the consortium propose to perform
under the grant to further the objectives of
this section;
(D) demonstrates the consortium’s ability
to build on the current system (as of the
date of submission of the application) for

Page 332

serving a community or geographic area of
uninsured and underinsured individuals by
involving providers who have traditionally
provided a significant volume of care for
that community;
(E) demonstrates the consortium’s ability
to develop coordinated systems of care that
either directly provide or ensure the prompt
provision of a broad range of high-quality,
accessible services, including, as appropriate, primary, secondary, and tertiary
services, as well as substance abuse treatment and mental health services in a manner that assures continuity of care in the
community or geographic area;
(F) provides evidence of community involvement in the development, implementation, and direction of the program that the
entity proposes to operate;
(G) demonstrates the consortium’s ability
to ensure that individuals participating in
the program are enrolled in public insurance
programs for which the individuals are eligible or know of private insurance programs
where available;
(H) presents a plan for leveraging other
sources of revenue, which may include State
and local sources and private grant funds,
and integrating current and proposed new
funding sources in a way to assure long-term
sustainability of the program;
(I) describes a plan for evaluation of the
activities carried out under the grant, including measurement of progress toward the
goals and objectives of the program and the
use of evaluation findings to improve program performance;
(J) demonstrates fiscal responsibility
through the use of appropriate accounting
procedures and appropriate management
systems;
(K) demonstrates the consortium’s commitment to serve the community without
regard to the ability of an individual or family to pay by arranging for or providing free
or reduced charge care for the poor; and
(L) includes such other information as the
Secretary may prescribe.
(c) Limitations
(1) Number of awards
(A) In general
For each of fiscal years 2003, 2004, 2005, and
2006, the Secretary may not make more than
35 new awards under subsection (a) of this
section (excluding renewals of such awards).
(B) Rule of construction
This paragraph shall not be construed to
affect awards made before fiscal year 2003.
(2) In general
An eligible entity may not receive a grant
under this section (including with respect to
any such grant made before fiscal year 2003)
for more than 3 consecutive fiscal years, except that such entity may receive such a grant
award for not more than 1 additional fiscal
year if—
(A) the eligible entity submits to the Secretary a request for a grant for such an additional fiscal year;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the Secretary determines that extraordinary circumstances (as defined in paragraph (3)) justify the granting of such request; and
(C) the Secretary determines that granting
such request is necessary to further the objectives described in subsection (a) of this
section.
(3) Extraordinary circumstances
(A) In general
In paragraph (2), the term ‘‘extraordinary
circumstances’’ means an event (or events)
that is outside of the control of the eligible
entity that has prevented the eligible entity
from fulfilling the objectives described by
such entity in the application submitted
under subsection (b)(2) of this section.
(B) Examples
Extraordinary circumstances include—
(i) natural disasters or other major disruptions to the security or health of the
community or geographic area served by
the eligible entity; or
(ii) a significant economic deterioration
in the community or geographic area
served by such eligible entity, that directly and adversely affects the entity receiving an award under subsection (a) of
this section.
(d) Priorities
In awarding grants under this section, the Secretary—
(1) shall accord priority to applicants that
demonstrate the extent of unmet need in the
community involved for a more coordinated
system of care; and
(2) may accord priority to applicants that
best promote the objectives of this section,
taking into consideration the extent to which
the application involved—
(A) identifies a community whose geographical area has a high or increasing percentage of individuals who are uninsured;
(B) demonstrates that the applicant has
included in its consortium providers, support systems, and programs that have a tradition of serving uninsured individuals and
underinsured individuals in the community;
(C) shows evidence that the program would
expand utilization of preventive and primary
care services for uninsured and underinsured
individuals and families in the community,
including behavioral and mental health services, oral health services, or substance abuse
services;
(D) proposes a program that would improve coordination between health care providers and appropriate social service providers;
(E) demonstrates collaboration with State
and local governments;
(F) demonstrates that the applicant makes
use of non-Federal contributions to the
greatest extent possible; or
(G) demonstrates a likelihood that the
proposed program will continue after support under this section ceases.

§ 256

(e) Use of funds
(1) Use by grantees
(A) In general
Except as provided in paragraphs (2) and
(3), a grantee may use amounts provided
under this section only for—
(i) direct expenses associated with
achieving the greater integration of a
health care delivery system so that the
system either directly provides or ensures
the provision of a broad range of culturally competent services, as appropriate,
including primary, secondary, and tertiary
services, as well as substance abuse treatment and mental health services; and
(ii) direct patient care and service expansions to fill identified or documented gaps
within an integrated delivery system.
(B) Specific uses
The following are examples of purposes for
which a grantee may use grant funds under
this section, when such use meets the conditions stated in subparagraph (A):
(i) Increases in outreach activities and
closing gaps in health care service.
(ii) Improvements to case management.
(iii) Improvements to coordination of
transportation to health care facilities.
(iv) Development of provider networks
and other innovative models to engage
physicians in voluntary efforts to serve
the medically underserved within a community.
(v) Recruitment, training, and compensation of necessary personnel.
(vi) Acquisition of technology for the
purpose of coordinating care.
(vii) Improvements to provider communication, including implementation of
shared information systems or shared clinical systems.
(viii) Development of common processes
for determining eligibility for the programs provided through the system, including creating common identification
cards and single sliding scale discounts.
(ix) Development of specific prevention
and disease management tools and processes.
(x) Translation services.
(xi) Carrying out other activities that
may be appropriate to a community and
that would increase access by the uninsured to health care, such as access initiatives for which private entities provide
non-Federal contributions to supplement
the Federal funds provided through the
grants for the initiatives.
(2) Direct patient care limitation
Not more than 15 percent of the funds provided under a grant awarded under this section
may be used for providing direct patient care
and services.
(3) Reservation of funds for national program
purposes
The Secretary may use not more than 3 percent of funds appropriated to carry out this
section for providing technical assistance to

§ 256

TITLE 42—THE PUBLIC HEALTH AND WELFARE

grantees, obtaining assistance of experts and
consultants, holding meetings, developing of
tools, disseminating of information, evaluation, and carrying out activities that will extend the benefits of programs funded under
this section to communities other than the
community served by the program funded.
(f) Grantee requirements
(1) Evaluation of effectiveness
A grantee under this section shall—
(A) report to the Secretary annually regarding—
(i) progress in meeting the goals and
measurable objectives set forth in the
grant application submitted by the grantee under subsection (b) of this section; and
(ii) the extent to which activities conducted by such grantee have—
(I) improved the effectiveness, efficiency, and coordination of services for
uninsured and underinsured individuals
in the communities or geographic areas
served by such grantee;
(II) resulted in the provision of better
quality health care for such individuals;
and
(III) resulted in the provision of health
care to such individuals at lower cost
than would have been possible in the absence of the activities conducted by such
grantee; and
(B) provide for an independent annual financial audit of all records that relate to
the disposition of funds received through the
grant.
(2) Progress
The Secretary may not renew an annual
grant under this section for an entity for a fiscal year unless the Secretary is satisfied that
the consortium represented by the entity has
made reasonable and demonstrable progress in
meeting the goals and measurable objectives
set forth in the entity’s grant application for
the preceding fiscal year.
(g) Maintenance of effort
With respect to activities for which a grant
under this section is authorized, the Secretary
may award such a grant only if the applicant for
the grant, and each of the participating providers, agree that the grantee and each such provider will maintain its expenditures of non-Federal funds for such activities at a level that is
not less than the level of such expenditures during the fiscal year immediately preceding the
fiscal year for which the applicant is applying to
receive such grant.
(h) Technical assistance
The Secretary may, either directly or by grant
or contract, provide any entity that receives a
grant under this section with technical and
other nonfinancial assistance necessary to meet
the requirements of this section.
(i) Evaluation of program
Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate committees of Congress a report that describes the extent to which projects funded

Page 334

under this section have been successful in improving the effectiveness, efficiency, and coordination of services for uninsured and underinsured individuals in the communities or geographic areas served by such projects, including
whether the projects resulted in the provision of
better quality health care for such individuals,
and whether such care was provided at lower
costs, than would have been provided in the absence of such projects.
(j) Demonstration authority
The Secretary may make demonstration
awards under this section to historically black
health professions schools for the purposes of—
(1) developing patient-based research infrastructure at historically black health professions schools, which have an affiliation, or affiliations, with any of the providers identified
in subsection (b)(1)(B) of this section;
(2) establishment of joint and collaborative
programs of medical research and data collection between historically black health professions schools and such providers, whose goal is
to improve the health status of medically underserved populations; or
(3) supporting the research-related costs of
patient care, data collection, and academic
training resulting from such affiliations.
(k) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2002 through 2006.
(l) Date certain for termination of program
Funds may not be appropriated to carry out
this section after September 30, 2006.
(July 1, 1944, ch. 373, title III, § 340, as added Pub.
L. 107–251, title IV, § 402, Oct. 26, 2002, 116 Stat.
1655.)
PRIOR PROVISIONS
A prior section 256, act July 1, 1944, ch. 373, title III,
§ 340, as added July 22, 1987, Pub. L. 100–77, title VI, § 601,
101 Stat. 511; amended Nov. 4, 1988, Pub. L. 100–607, title
VIII, §§ 801(a), (c), 802(a), (b)(1), 803, 804, 102 Stat. 3168,
3169; Nov. 7, 1988, Pub. L. 100–628, title VI, §§ 601(a), (c),
602(a), (b)(1), 603, 604, 102 Stat. 3241, 3242; Aug. 16, 1989,
Pub. L. 101–93, § 5(t)(1), (3), 103 Stat. 615; Nov. 29, 1990,
Pub. L. 101–645, title V, §§ 501–503, 104 Stat. 4724; Oct. 27,
1992, Pub. L. 102–531, title III, § 309(c), 106 Stat. 3501, related to grant program for certain health services for
the homeless, prior to repeal by Pub. L. 104–299,
§ 4(a)(3), Oct. 11, 1996, 110 Stat. 3645, eff. Oct. 1, 1996.
Another prior section 256, act July 1, 1944, ch. 373,
title III, § 340, as added Nov. 10, 1978, Pub. L. 95–626, title
I, § 115(2), 92 Stat. 3567; amended Dec. 12, 1979, Pub. L.
96–142, title III, § 301(a), 93 Stat. 1073; Aug. 13, 1981, Pub.
L. 97–35, title IX, § 903(b)(1), 95 Stat. 561; Jan. 4, 1983,
Pub. L. 97–414, § 8(h), 96 Stat. 2061, related to primary
care research and demonstration projects to serve
medically underserved population, prior to repeal by
Pub. L. 97–35, title IX, § 903(c), Aug. 13, 1981, 95 Stat. 561,
eff. Oct. 1, 1982.
Another prior section 256, act July 1, 1944, ch. 373,
title III, § 340, formerly § 332, 58 Stat. 698; renumbered
§ 340, Oct. 12, 1976, Pub. L. 94–484, title IV, § 407(b)(2), 90
Stat. 2268, related to apprehension, detention, treatment, and release of persons being treated for leprosy,
prior to repeal by Pub. L. 95–626, title I, § 105(b), Nov. 10,
1978, 92 Stat. 3560.
DEMONSTRATION PROJECT TO PROVIDE ACCESS TO
AFFORDABLE CARE
Pub. L. 111–148, title X, § 10504, Mar. 23, 2010, 124 Stat.
1004, provided that:

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‘‘(a) IN GENERAL.—Not later than 6 months after the
date of enactment of this Act [Mar. 23, 2010], the Secretary of Health and Human Services (referred to in
this section as the ‘Secretary’), acting through the
Health Resources and Services Administration, shall
establish a 3 year demonstration project in up to 10
States to provide access to comprehensive health care
services to the uninsured at reduced fees. The Secretary shall evaluate the feasibility of expanding the
project to additional States.
‘‘(b) ELIGIBILITY.—To be eligible to participate in the
demonstration project, an entity shall be a Statebased, nonprofit, public-private partnership that provides access to comprehensive health care services to
the uninsured at reduced fees. Each State in which a
participant selected by the Secretary is located shall
receive not more than $2,000,000 to establish and carry
out the project for the 3-year demonstration period.
‘‘(c) AUTHORIZATION.—There is authorized to be appropriated such sums as may be necessary to carry out
this section.’’
PURPOSE
Pub. L. 107–251, title IV, § 401, Oct. 26, 2002, 116 Stat.
1655, provided that: ‘‘The purpose of this title [enacting
this subpart and subpart X (§ 256f et seq.) of this part
and provisions set out as a note under section 1396a of
this title] is to provide assistance to communities and
consortia of health care providers and others, to develop or strengthen integrated community health care
delivery systems that coordinate health care services
for individuals who are uninsured or underinsured and
to develop or strengthen activities related to providing
coordinated care for individuals with chronic conditions who are uninsured or underinsured, through the—
‘‘(1) coordination of services to allow individuals to
receive efficient and higher quality care and to gain
entry into and receive services from a comprehensive
system of care;
‘‘(2) development of the infrastructure for a health
care delivery system characterized by effective collaboration, information sharing, and clinical and financial coordination among all providers of care in
the community; and
‘‘(3) provision of new Federal resources that do not
supplant funding for existing Federal categorical programs that support entities providing services to lowincome populations.’’

§ 256a. Patient navigator grants
(a) Grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve health care outcomes.
The Secretary shall coordinate with, and ensure
the participation of, the Indian Health Service,
the National Cancer Institute, the Office of
Rural Health Policy, and such other offices and
agencies as deemed appropriate by the Secretary, regarding the design and evaluation of
the demonstration programs.
(b) Use of funds
The Secretary shall require each recipient of a
grant under this section to use the grant to recruit, assign, train, and employ patient navigators who have direct knowledge of the communities they serve to facilitate the care of individuals, including by performing each of the following duties:
(1) Acting as contacts, including by assisting
in the coordination of health care services and
provider referrals, for individuals who are

§ 256a

seeking prevention or early detection services
for, or who following a screening or early detection service are found to have a symptom,
abnormal finding, or diagnosis of, cancer or
other chronic disease.
(2) Facilitating the involvement of community organizations in assisting individuals who
are at risk for or who have cancer or other
chronic diseases to receive better access to
high-quality health care services (such as by
creating partnerships with patient advocacy
groups, charities, health care centers, community hospice centers, other health care providers, or other organizations in the targeted
community).
(3) Notifying individuals of clinical trials
and, on request, facilitating enrollment of eligible individuals in these trials.
(4) Anticipating, identifying, and helping patients to overcome barriers within the health
care system to ensure prompt diagnostic and
treatment resolution of an abnormal finding
of cancer or other chronic disease.
(5) Coordinating with the relevant health insurance ombudsman programs to provide information to individuals who are at risk for or
who have cancer or other chronic diseases
about health coverage, including private insurance, health care savings accounts, and
other publicly funded programs (such as Medicare, Medicaid, health programs operated by
the Department of Veterans Affairs or the Department of Defense, the State children’s
health insurance program, and any private or
governmental prescription assistance programs).
(6) Conducting ongoing outreach to health
disparity populations, including the uninsured, rural populations, and other medically
underserved populations, in addition to assisting other individuals who are at risk for or
who have cancer or other chronic diseases to
seek preventative care.
(c) Prohibitions
(1) Referral fees
The Secretary shall require each recipient of
a grant under this section to prohibit any patient navigator providing services under the
grant from accepting any referral fee, kickback, or other thing of value in return for referring an individual to a particular health
care provider.
(2) Legal fees and costs
The Secretary shall prohibit the use of any
grant funds received under this section to pay
any fees or costs resulting from any litigation,
arbitration, mediation, or other proceeding to
resolve a legal dispute.
(d) Grant period
(1) In general
Subject to paragraphs (2) and (3), the Secretary may award grants under this section
for periods of not more than 3 years.
(2) Extensions
Subject to paragraph (3), the Secretary may
extend the period of a grant under this section. Each such extension shall be for a period
of not more than 1 year.

§ 256a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Limitations on grant period
In carrying out this section, the Secretary
shall ensure that the total period of a grant
does not exceed 4 years.
(e) Application
(1) In general
To seek a grant under this section, an eligible entity shall submit an application to the
Secretary in such form, in such manner, and
containing such information as the Secretary
may require.
(2) Contents
At a minimum, the Secretary shall require
each such application to outline how the eligible entity will establish baseline measures and
benchmarks that meet the Secretary’s requirements to evaluate program outcomes.
(3) Minimum core proficiencies
The Secretary shall not award a grant to an
entity under this section unless such entity
provides assurances that patient navigators
recruited, assigned, trained, or employed using
grant funds meet minimum core proficiencies,
as defined by the entity that submits the application, that are tailored for the main focus
or intervention of the navigator involved.
(f) Uniform baseline measures
The Secretary shall establish uniform baseline
measures in order to properly evaluate the impact of the demonstration projects under this
section.
(g) Preference
In making grants under this section, the Secretary shall give preference to eligible entities
that demonstrate in their applications plans to
utilize patient navigator services to overcome
significant barriers in order to improve health
care outcomes in their respective communities.
(h) Duplication of services
An eligible entity that is receiving Federal
funds for activities described in subsection (b) of
this section on the date on which the entity submits an application under subsection (e) of this
section may not receive a grant under this section unless the entity can demonstrate that
amounts received under the grant will be utilized to expand services or provide new services
to individuals who would not otherwise be
served.
(i) Coordination with other programs
The Secretary shall ensure coordination of the
demonstration grant program under this section
with existing authorized programs in order to
facilitate access to high-quality health care
services.
(j) Study; reports
(1) Final report by Secretary
Not later than 6 months after the completion of the demonstration grant program
under this section, the Secretary shall conduct a study of the results of the program and
submit to the Congress a report on such results that includes the following:
(A) An evaluation of the program outcomes, including—

Page 336

(i) quantitative analysis of baseline and
benchmark measures; and
(ii) aggregate information about the patients served and program activities.
(B) Recommendations on whether patient
navigator programs could be used to improve patient outcomes in other public
health areas.
(2) Interim reports by Secretary
The Secretary may provide interim reports
to the Congress on the demonstration grant
program under this section at such intervals
as the Secretary determines to be appropriate.
(3) Reports by grantees
The Secretary may require grant recipients
under this section to submit interim and final
reports on grant program outcomes.
(k) Rule of construction
This section shall not be construed to authorize funding for the delivery of health care services (other than the patient navigator duties
listed in subsection (b) of this section).
(l) Definitions
In this section:
(1) The term ‘‘eligible entity’’ means a public or nonprofit private health center (including a Federally qualified health center (as
that term is defined in section 1395x(aa)(4) of
this title)), a health facility operated by or
pursuant to a contract with the Indian Health
Service, a hospital, a cancer center, a rural
health clinic, an academic health center, or a
nonprofit entity that enters into a partnership
or coordinates referrals with such a center,
clinic, facility, or hospital to provide patient
navigator services.
(2) The term ‘‘health disparity population’’
means a population that, as determined by the
Secretary, has a significant disparity in the
overall rate of disease incidence, prevalence,
morbidity, mortality, or survival rates as
compared to the health status of the general
population.
(3) The term ‘‘patient navigator’’ means an
individual who has completed a training program approved by the Secretary to perform
the duties listed in subsection (b) of this section.
(m) Authorization of appropriations
(1) In general
To carry out this section, there are authorized to be appropriated $2,000,000 for fiscal year
2006, $5,000,000 for fiscal year 2007, $8,000,000 for
fiscal year 2008, $6,500,000 for fiscal year 2009,
$3,500,000 for fiscal year 2010, and such sums as
may be necessary for each of fiscal years 2011
through 2015.
(2) Availability
The amounts appropriated pursuant to paragraph (1) shall remain available for obligation
through the end of fiscal year 2015.
(July 1, 1944, ch. 373, title III, § 340A, as added
Pub. L. 109–18, § 2, June 29, 2005, 119 Stat. 340;
amended Pub. L. 111–148, title III, § 3510, Mar. 23,
2010, 124 Stat. 537.)
PRIOR PROVISIONS
A prior section 256a, act July 1, 1944, ch. 373, title III,
§ 340A, as added Nov. 6, 1990, Pub. L. 101–527, § 3, 104 Stat.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

2314; amended Oct. 27, 1992, Pub. L. 102–531, title III,
§ 309(d), 106 Stat. 3502, related to health services for
residents of public housing, prior to repeal by Pub. L.
104–299, §§ 4(a)(3), 5, Oct. 11, 1996, 110 Stat. 3645, effective
Oct. 1, 1996.
Another prior section 256a, act July 1, 1944, ch. 373,
title III, § 340A, as added Nov. 10, 1978, Pub. L. 95–626,
title I, § 106(a), 92 Stat. 3560, related to technical assistance demonstration grants and contracts, prior to repeal by Pub. L. 100–77, title VI, § 601, July 22, 1987, 101
Stat. 511.
AMENDMENTS
2010—Subsec. (d)(3). Pub. L. 111–148, § 3510(1), added
par. (3) and struck out former par. (3). Prior to amendment, text read as follows: ‘‘In carrying out this section, the Secretary—
‘‘(A) shall ensure that the total period of a grant
does not exceed 4 years; and
‘‘(B) may not authorize any grant period ending
after September 30, 2010.’’
Subsec. (e)(3). Pub. L. 111–148, § 3510(2), added par. (3).
Subsec. (m)(1). Pub. L. 111–148, § 3510(3)(A), substituted ‘‘$3,500,000 for fiscal year 2010, and such sums
as may be necessary for each of fiscal years 2011
through 2015’’ for ‘‘and $3,500,000 for fiscal year 2010’’.
Subsec. (m)(2). Pub. L. 111–148, § 3510(3)(B), substituted
‘‘2015’’ for ‘‘2010’’.

§ 256a–1. Establishing community health teams to
support the patient-centered medical home
(a) In general
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’)
shall establish a program to provide grants to or
enter into contracts with eligible entities to establish
community-based
interdisciplinary,
interprofessional teams (referred to in this section as ‘‘health teams’’) to support primary care
practices, including obstetrics and gynecology
practices, within the hospital service areas
served by the eligible entities. Grants or contracts shall be used to—
(1) establish health teams to provide support
services to primary care providers; and
(2) provide capitated payments to primary
care providers as determined by the Secretary.
(b) Eligible entities
To be eligible to receive a grant or contract
under subsection (a), an entity shall—
(1)(A) be a State or State-designated entity;
or
(B) be an Indian tribe or tribal organization,
as defined in section 1603 of title 25;
(2) submit a plan for achieving long-term financial sustainability within 3 years;
(3) submit a plan for incorporating prevention initiatives and patient education and care
management resources into the delivery of
health care that is integrated with community-based prevention and treatment resources, where available;
(4) ensure that the health team established
by the entity includes an interdisciplinary,
interprofessional team of health care providers, as determined by the Secretary; such
team may include medical specialists, nurses,
pharmacists, nutritionists, dieticians, social
workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of
chiropractic, licensed complementary and alternative medicine practitioners, and physicians’ assistants;

§ 256a–1

(5) agree to provide services to eligible individuals with chronic conditions, as described
in section 1396w–4 of this title (as added by
section 2703), in accordance with the payment
methodology established under subsection (c)
of such section; and
(6) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require.
(c) Requirements for health teams
A health team established pursuant to a grant
or contract under subsection (a) shall—
(1) establish contractual agreements with
primary care providers to provide support
services;
(2) support patient-centered medical homes,
defined as a mode of care that includes—
(A) personal physicians or other primary
care providers;
(B) whole person orientation;
(C) coordinated and integrated care;
(D) safe and high-quality care through evidence-informed medicine, appropriate use of
health information technology, and continuous quality improvements;
(E) expanded access to care; and
(F) payment that recognizes added value
from additional components of patient-centered care;
(3) collaborate with local primary care providers and existing State and community
based resources to coordinate disease prevention,
chronic
disease
management,
transitioning between health care providers
and settings and case management for patients, including children, with priority given
to those amenable to prevention and with
chronic diseases or conditions identified by
the Secretary;
(4) in collaboration with local health care
providers, develop and implement interdisciplinary, interprofessional care plans that
integrate clinical and community preventive
and health promotion services for patients, including children, with a priority given to
those amenable to prevention and with chronic diseases or conditions identified by the Secretary;
(5) incorporate health care providers, patients, caregivers, and authorized representatives in program design and oversight;
(6) provide support necessary for local primary care providers to—
(A) coordinate and provide access to highquality health care services;
(B) coordinate and provide access to preventive and health promotion services;
(C) provide access to appropriate specialty
care and inpatient services;
(D) provide quality-driven, cost-effective,
culturally appropriate, and patient- and
family-centered health care;
(E) provide access to pharmacist-delivered
medication management services, including
medication reconciliation;
(F) provide coordination of the appropriate
use of complementary and alternative (CAM)
services to those who request such services;
(G) promote effective strategies for treatment planning, monitoring health outcomes

§ 256b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and resource use, sharing information, treatment decision support, and organizing care
to avoid duplication of service and other
medical management approaches intended to
improve quality and value of health care
services;
(H) provide local access to the continuum
of health care services in the most appropriate setting, including access to individuals that implement the care plans of patients and coordinate care, such as integrative health care practitioners;
(I) collect and report data that permits
evaluation of the success of the collaborative effort on patient outcomes, including
collection of data on patient experience of
care, and identification of areas for improvement; and
(J) establish a coordinated system of early
identification and referral for children at
risk for developmental or behavioral problems such as through the use of infolines,
health information technology, or other
means as determined by the Secretary;
(7) provide 24-hour care management and
support during transitions in care settings including—
(A) a transitional care program that provides onsite visits from the care coordinator,1 assists with the development of discharge plans and medication reconciliation
upon admission to and discharge from the
hospitals,2 nursing home, or other institution setting;
(B) discharge planning and counseling support to providers, patients, caregivers, and
authorized representatives;
(C) assuring that post-discharge care plans
include medication management, as appropriate;
(D) referrals for mental and behavioral
health services, which may include the use
of infolines; and
(E) transitional health care needs from
adolescence to adulthood;
(8) serve as a liaison to community prevention and treatment programs;
(9) demonstrate a capacity to implement and
maintain health information technology that
meets the requirements of certified EHR technology (as defined in section 300jj of this title)
to facilitate coordination among members of
the applicable care team and affiliated primary care practices; and
(10) where applicable, report to the Secretary information on quality measures used
under section 280j–2 of this title.
(d) Requirement for primary care providers
A provider who contracts with a care team
shall—
(1) provide a care plan to the care team for
each patient participant;
(2) provide access to participant health
records; and
(3) meet regularly with the care team to ensure integration of care.
1 So
2 So

in original. The comma probably should be ‘‘and’’.
in original. Probably should be ‘‘hospital,’’.

Page 338

(e) Reporting to Secretary
An entity that receives a grant or contract
under subsection (a) shall submit to the Secretary a report that describes and evaluates, as
requested by the Secretary, the activities carried out by the entity under subsection (c).
(f) Definition of primary care
In this section, the term ‘‘primary care’’
means the provision of integrated, accessible
health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained
partnership with patients, and practicing in the
context of family and community.
(Pub. L. 111–148, title III, § 3502, title X, § 10321,
Mar. 23, 2010, 124 Stat. 513, 952.)
REFERENCES IN TEXT
Section 2703, referred to in subsec. (b)(5), means section 2703 of Pub. L. 111–148.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (c)(2)(A). Pub. L. 111–148, § 10321, inserted ‘‘or other primary care providers’’ after ‘‘physicians’’.
SUBPART VII—DRUG PRICING AGREEMENTS

§ 256b. Limitation on prices of drugs purchased
by covered entities
(a) Requirements for agreement with Secretary
(1) In general
The Secretary shall enter into an agreement
with each manufacturer of covered outpatient
drugs under which the amount required to be
paid (taking into account any rebate or discount, as provided by the Secretary) to the
manufacturer for covered outpatient drugs
(other than drugs described in paragraph (3))
purchased by a covered entity on or after the
first day of the first month that begins after
November 4, 1992, does not exceed an amount
equal to the average manufacturer price for
the drug under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] in the preceding calendar quarter, reduced by the rebate
percentage described in paragraph (2). Each
such agreement shall require that the manufacturer furnish the Secretary with reports, on
a quarterly basis, of the price for each covered
outpatient drug subject to the agreement that,
according to the manufacturer, represents the
maximum price that covered entities may permissibly be required to pay for the drug (referred to in this section as the ‘‘ceiling
price’’), and shall require that the manufacturer offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made
available to any other purchaser at any price.
(2) ‘‘Rebate percentage’’ defined
(A) In general
For a covered outpatient drug purchased
in a calendar quarter, the ‘‘rebate percent-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

age’’ is the amount (expressed as a percentage) equal to—
(i) the average total rebate required
under section 1927(c) of the Social Security
Act [42 U.S.C. 1396r–8(c)] with respect to
the drug (for a unit of the dosage form and
strength involved) during the preceding
calendar quarter; divided by
(ii) the average manufacturer price for
such a unit of the drug during such quarter.
(B) Over the counter drugs
(i) In general
For purposes of subparagraph (A), in the
case of over the counter drugs, the ‘‘rebate
percentage’’ shall be determined as if the
rebate required under section 1927(c) of the
Social Security Act [42 U.S.C. 1396r–8(c)] is
based on the applicable percentage provided under section 1927(c)(3) of such Act.
(ii) ‘‘Over the counter drug’’ defined
The term ‘‘over the counter drug’’ means
a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).
(3) Drugs provided under State medicaid plans
Drugs described in this paragraph are drugs
purchased by the entity for which payment is
made by the State under the State plan for
medical assistance under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.].
(4) ‘‘Covered entity’’ defined
In this section, the term ‘‘covered entity’’
means an entity that meets the requirements
described in paragraph (5) and is one of the following:
(A) A Federally-qualified health center (as
defined in section 1905(l)(2)(B) of the Social
Security Act [42 U.S.C. 1396d(l)(2)(B)]).
(B) An entity receiving a grant under section 256a 1 of this title.
(C) A family planning project receiving a
grant or contract under section 300 of this
title.
(D) An entity receiving a grant under subpart II 1 of part C of subchapter XXIV of this
chapter (relating to categorical grants for
outpatient early intervention services for
HIV disease).
(E) A State-operated AIDS drug purchasing assistance program receiving financial
assistance under subchapter XXIV of this
chapter.
(F) A black lung clinic receiving funds
under section 937(a) of title 30.
(G) A comprehensive hemophilia diagnostic treatment center receiving a grant
under section 501(a)(2) of the Social Security
Act [42 U.S.C. 701(a)(2)].
(H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian
Health Care Act of 1988.
(I) An urban Indian organization receiving
funds under title V of the Indian Health Care
Improvement Act [25 U.S.C. 1651 et seq.].
1 See

References in Text note below.

§ 256b

(J) Any entity receiving assistance under
subchapter XXIV of this chapter (other than
a State or unit of local government or an entity described in subparagraph (D)), but only
if the entity is certified by the Secretary
pursuant to paragraph (7).
(K) An entity receiving funds under section 247c of this title (relating to treatment
of sexually transmitted diseases) or section
247b(j)(2) 1 of this title (relating to treatment
of tuberculosis) through a State or unit of
local government, but only if the entity is
certified by the Secretary pursuant to paragraph (7).
(L) A subsection (d) hospital (as defined in
section 1886(d)(1)(B) of the Social Security
Act [42 U.S.C. 1395ww(d)(1)(B)]) that—
(i) is owned or operated by a unit of
State or local government, is a public or
private non-profit corporation which is
formally granted governmental powers by
a unit of State or local government, or is
a private non-profit hospital which has a
contract with a State or local government
to provide health care services to low income individuals who are not entitled to
benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] or eligible for assistance under the State plan
under this subchapter;
(ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a disproportionate share
adjustment percentage (as determined
under section 1886(d)(5)(F) of the Social Security Act [42 U.S.C. 1395ww(d)(5)(F)])
greater than 11.75 percent or was described
in section 1886(d)(5)(F)(i)(II) of such Act [42
U.S.C. 1395ww(d)(5)(F)(i)(II)]; and
(iii) does not obtain covered outpatient
drugs through a group purchasing organization or other group purchasing arrangement.
(M) A children’s hospital excluded from
the Medicare prospective payment system
pursuant to section 1886(d)(1)(B)(iii) of the
Social
Security
Act
[42
U.S.C.
1395ww(d)(1)(B)(iii)], or a free-standing cancer hospital excluded from the Medicare prospective payment system pursuant to section 1886(d)(1)(B)(v) of the Social Security
Act, that would meet the requirements of
subparagraph (L), including the disproportionate share adjustment percentage requirement under clause (ii) of such subparagraph, if the hospital were a subsection (d)
hospital as defined by section 1886(d)(1)(B) of
the Social Security Act.
(N) An entity that is a critical access hospital (as determined under section 1820(c)(2)
of the Social Security Act [42 U.S.C.
1395i–4(c)(2)]), and that meets the requirements of subparagraph (L)(i).
(O) An entity that is a rural referral center, as defined by section 1886(d)(5)(C)(i) of
the
Social
Security
Act
[42
U.S.C.
1395ww(d)(5)(C)(i)], or a sole community hospital, as defined by section 1886(d)(5)(C)(iii)
of such Act, and that both meets the requirements of subparagraph (L)(i) and has a
disproportionate share adjustment percentage equal to or greater than 8 percent.

§ 256b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Requirements for covered entities
(A) Prohibiting duplicate discounts or rebates
(i) In general
A covered entity shall not request payment under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for medical
assistance described in section 1905(a)(12)
of such Act [42 U.S.C. 1396d(a)(12)] with respect to a drug that is subject to an agreement under this section if the drug is subject to the payment of a rebate to the
State under section 1927 of such Act [42
U.S.C. 1396r–8].
(ii) Establishment of mechanism
The Secretary shall establish a mechanism to ensure that covered entities comply with clause (i). If the Secretary does
not establish a mechanism within 12
months under the previous sentence, the
requirements of section 1927(a)(5)(C) of the
Social
Security
Act
[42
U.S.C.
1396r–8(a)(5)(C)] shall apply.
(B) Prohibiting resale of drugs
With respect to any covered outpatient
drug that is subject to an agreement under
this subsection, a covered entity shall not
resell or otherwise transfer the drug to a
person who is not a patient of the entity.
(C) Auditing
A covered entity shall permit the Secretary and the manufacturer of a covered
outpatient drug that is subject to an agreement under this subsection with the entity
(acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit
at the Secretary’s or the manufacturer’s expense the records of the entity that directly
pertain to the entity’s compliance with the
requirements described in subparagraphs 2
(A) or (B) with respect to drugs of the manufacturer.
(D) Additional sanction for noncompliance
If the Secretary finds, after audit as described in subparagraph (C) and after notice
and hearing, that a covered entity is in violation of a requirement described in subparagraphs 2 (A) or (B), the covered entity shall
be liable to the manufacturer of the covered
outpatient drug that is the subject of the
violation in an amount equal to the reduction in the price of the drug (as described in
subparagraph (A)) provided under the agreement between the entity and the manufacturer under this paragraph.
(6) Treatment of distinct units of hospitals
In the case of a covered entity that is a distinct part of a hospital, the hospital shall not
be considered a covered entity under this paragraph unless the hospital is otherwise a covered entity under this subsection.
(7) Certification of certain covered entities
(A) Development of process
Not later than 60 days after November 4,
1992, the Secretary shall develop and imple2 So

in original. Probably should be ‘‘subparagraph’’.

Page 340

ment a process for the certification of entities described in subparagraphs (J) and (K)
of paragraph (4).
(B) Inclusion of purchase information
The process developed under subparagraph
(A) shall include a requirement that an entity applying for certification under this
paragraph submit information to the Secretary concerning the amount such entity
expended for covered outpatient drugs in the
preceding year so as to assist the Secretary
in evaluating the validity of the entity’s
subsequent purchases of covered outpatient
drugs at discounted prices.
(C) Criteria
The Secretary shall make available to all
manufacturers of covered outpatient drugs a
description of the criteria for certification
under this paragraph.
(D) List of purchasers and dispensers
The certification process developed by the
Secretary under subparagraph (A) shall include procedures under which each State
shall, not later than 30 days after the submission of the descriptions under subparagraph (C), prepare and submit a report to the
Secretary that contains a list of entities described in subparagraphs (J) and (K) of paragraph (4) that are located in the State.
(E) Recertification
The Secretary shall require the recertification of entities certified pursuant to
this paragraph on a not more frequent than
annual basis, and shall require that such entities submit information to the Secretary
to permit the Secretary to evaluate the validity of subsequent purchases by such entities in the same manner as that required
under subparagraph (B).
(8) Development of prime vendor program
The Secretary shall establish a prime vendor
program under which covered entities may
enter into contracts with prime vendors for
the distribution of covered outpatient drugs. If
a covered entity obtains drugs directly from a
manufacturer, the manufacturer shall be responsible for the costs of distribution.
(9) Notice to manufacturers
The Secretary shall notify manufacturers of
covered outpatient drugs and single State
agencies under section 1902(a)(5) of the Social
Security Act [42 U.S.C. 1396a(a)(5)] of the identities of covered entities under this paragraph,
and of entities that no longer meet the requirements of paragraph (5) or that are no
longer certified pursuant to paragraph (7).
(10) No prohibition on larger discount
Nothing in this subsection shall prohibit a
manufacturer from charging a price for a drug
that is lower than the maximum price that
may be charged under paragraph (1).
(b) Other definitions
(1) In general
In this section, the terms ‘‘average manufacturer price’’, ‘‘covered outpatient drug’’, and

Page 341

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘manufacturer’’ have the meaning given such
terms in section 1927(k) of the Social Security
Act [42 U.S.C. 1396r–8(k)].
(2) Covered drug
In this section, the term ‘‘covered drug’’—
(A) means a covered outpatient drug (as
defined in section 1927(k)(2) of the Social Security Act [42 U.S.C. 1396r–8(k)(2)]); and
(B) includes, notwithstanding paragraph
(3)(A) of section 1927(k) of such Act [42 U.S.C.
1396r–8(k)(3)(A)], a drug used in connection
with an inpatient or outpatient service provided by a hospital described in subparagraph (L), (M), (N), or (O) of subsection (a)(4)
that is enrolled to participate in the drug
discount program under this section.
(c) Repealed. Pub. L. 111–152, title II, § 2302(2),
Mar. 30, 2010, 124 Stat. 1083
(d) Improvements in program integrity
(1) Manufacturer compliance
(A) In general
From amounts appropriated under paragraph (4), the Secretary shall provide for improvements in compliance by manufacturers
with the requirements of this section in
order to prevent overcharges and other violations of the discounted pricing requirements specified in this section.
(B) Improvements
The improvements described in subparagraph (A) shall include the following:
(i) The development of a system to enable the Secretary to verify the accuracy
of ceiling prices calculated by manufacturers under subsection (a)(1) and charged to
covered entities, which shall include the
following:
(I) Developing and publishing through
an appropriate policy or regulatory issuance, precisely defined standards and
methodology for the calculation of ceiling prices under such subsection.
(II) Comparing regularly the ceiling
prices calculated by the Secretary with
the quarterly pricing data that is reported by manufacturers to the Secretary.
(III) Performing spot checks of sales
transactions by covered entities.
(IV) Inquiring into the cause of any
pricing discrepancies that may be identified and either taking, or requiring manufacturers to take, such corrective action as is appropriate in response to such
price discrepancies.
(ii) The establishment of procedures for
manufacturers to issue refunds to covered
entities in the event that there is an overcharge by the manufacturers, including
the following:
(I) Providing the Secretary with an explanation of why and how the overcharge
occurred, how the refunds will be calculated, and to whom the refunds will be
issued.
(II) Oversight by the Secretary to ensure that the refunds are issued accu-

§ 256b

rately and within a reasonable period of
time, both in routine instances of retroactive adjustment to relevant pricing
data and exceptional circumstances such
as erroneous or intentional overcharging
for covered outpatient drugs.
(iii) The provision of access through the
Internet website of the Department of
Health and Human Services to the applicable ceiling prices for covered outpatient
drugs as calculated and verified by the
Secretary in accordance with this section,
in a manner (such as through the use of
password protection) that limits such access to covered entities and adequately assures security and protection of privileged
pricing data from unauthorized re-disclosure.
(iv) The development of a mechanism by
which—
(I) rebates and other discounts provided by manufacturers to other purchasers subsequent to the sale of covered
outpatient drugs to covered entities are
reported to the Secretary; and
(II) appropriate credits and refunds are
issued to covered entities if such discounts or rebates have the effect of lowering the applicable ceiling price for the
relevant quarter for the drugs involved.
(v) Selective auditing of manufacturers
and wholesalers to ensure the integrity of
the drug discount program under this section.
(vi) The imposition of sanctions in the
form of civil monetary penalties, which—
(I) shall be assessed according to
standards established in regulations to
be promulgated by the Secretary not
later than 180 days after March 23, 2010;
(II) shall not exceed $5,000 for each instance of overcharging a covered entity
that may have occurred; and
(III) shall apply to any manufacturer
with an agreement under this section
that
knowingly
and
intentionally
charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection
(a)(1).
(2) Covered entity compliance
(A) In general
From amounts appropriated under paragraph (4), the Secretary shall provide for improvements in compliance by covered entities with the requirements of this section in
order to prevent diversion and violations of
the duplicate discount provision and other
requirements specified under subsection
(a)(5).
(B) Improvements
The improvements described in subparagraph (A) shall include the following:
(i) The development of procedures to enable and require covered entities to regularly update (at least annually) the information on the Internet website of the Department of Health and Human Services
relating to this section.

§ 256b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) The development of a system for the
Secretary to verify the accuracy of information regarding covered entities that is
listed on the website described in clause
(i).
(iii) The development of more detailed
guidance describing methodologies and options available to covered entities for billing covered outpatient drugs to State Medicaid agencies in a manner that avoids duplicate discounts pursuant to subsection
(a)(5)(A).
(iv) The establishment of a single, universal, and standardized identification system by which each covered entity site can
be identified by manufacturers, distributors, covered entities, and the Secretary
for purposes of facilitating the ordering,
purchasing, and delivery of covered outpatient drugs under this section, including
the processing of chargebacks for such
drugs.
(v) The imposition of sanctions, in appropriate cases as determined by the Secretary, additional to those to which covered entities are subject under subsection
(a)(5)(D), through one or more of the following actions:
(I) Where a covered entity knowingly
and intentionally violates subsection
(a)(5)(B), the covered entity shall be required to pay a monetary penalty to a
manufacturer or manufacturers in the
form of interest on sums for which the
covered entity is found liable under subsection (a)(5)(D), such interest to be
compounded monthly and equal to the
current short term interest rate as determined by the Federal Reserve for the
time period for which the covered entity
is liable.
(II) Where the Secretary determines a
violation of subsection (a)(5)(B) was systematic and egregious as well as knowing and intentional, removing the covered entity from the drug discount program under this section and disqualifying the entity from re-entry into such
program for a reasonable period of time
to be determined by the Secretary.
(III) Referring matters to appropriate
Federal authorities within the Food and
Drug Administration, the Office of Inspector General of Department of Health
and Human Services, or other Federal
agencies for consideration of appropriate
action under other Federal statutes,
such as the Prescription Drug Marketing
Act (21 U.S.C. 353).1
(3) Administrative dispute resolution process
(A) In general
Not later than 180 days after March 23,
2010, the Secretary shall promulgate regulations to establish and implement an administrative process for the resolution of claims
by covered entities that they have been
overcharged for drugs purchased under this
section, and claims by manufacturers, after
the conduct of audits as authorized by subsection (a)(5)(C), of violations of sub-

Page 342

sections 3 (a)(5)(A) or (a)(5)(B), including appropriate procedures for the provision of
remedies and enforcement of determinations
made pursuant to such process through
mechanisms and sanctions described in paragraphs (1)(B) and (2)(B).
(B) Deadlines and procedures
Regulations promulgated by the Secretary
under subparagraph (A) shall—
(i) designate or establish a decision-making official or decision-making body within the Department of Health and Human
Services to be responsible for reviewing
and finally resolving claims by covered entities that they have been charged prices
for covered outpatient drugs in excess of
the ceiling price described in subsection
(a)(1), and claims by manufacturers that
violations of subsection (a)(5)(A) or
(a)(5)(B) have occurred;
(ii) establish such deadlines and procedures as may be necessary to ensure that
claims shall be resolved fairly, efficiently,
and expeditiously;
(iii) establish procedures by which a covered entity may discover and obtain such
information and documents from manufacturers and third parties as may be relevant
to demonstrate the merits of a claim that
charges for a manufacturer’s product have
exceeded the applicable ceiling price under
this section, and may submit such documents and information to the administrative official or body responsible for adjudicating such claim;
(iv) require that a manufacturer conduct
an audit of a covered entity pursuant to
subsection (a)(5)(C) as a prerequisite to initiating administrative dispute resolution
proceedings against a covered entity;
(v) permit the official or body designated
under clause (i), at the request of a manufacturer or manufacturers, to consolidate
claims brought by more than one manufacturer against the same covered entity
where, in the judgment of such official or
body, consolidation is appropriate and consistent with the goals of fairness and economy of resources; and
(vi) include provisions and procedures to
permit multiple covered entities to jointly
assert claims of overcharges by the same
manufacturer for the same drug or drugs
in one administrative proceeding, and permit such claims to be asserted on behalf of
covered entities by associations or organizations representing the interests of such
covered entities and of which the covered
entities are members.
(C) Finality of administrative resolution
The administrative resolution of a claim
or claims under the regulations promulgated
under subparagraph (A) shall be a final agency decision and shall be binding upon the
parties involved, unless invalidated by an
order of a court of competent jurisdiction.
(4) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection, such sums as may
3 So

in original. Probably should be ‘‘subsection’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

be necessary for fiscal year 2010 and each succeeding fiscal year.
(e) Exclusion of orphan drugs for certain covered entities
For covered entities described in subparagraph
(M) (other than a children’s hospital described
in subparagraph (M)), (N), or (O) of subsection
(a)(4), the term ‘‘covered outpatient drug’’ shall
not include a drug designated by the Secretary
under section 360bb of title 21 for a rare disease
or condition.
(July 1, 1944, ch. 373, title III, § 340B, as added
Pub. L. 102–585, title VI, § 602(a), Nov. 4, 1992, 106
Stat. 4967; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(A), June 10, 1993, 107 Stat. 212; Pub. L.
111–148,
title
II,
§ 2501(f)(1),
title
VII,
§§ 7101(a)–(d), 7102, Mar. 23, 2010, 124 Stat. 309,
821–823; Pub. L. 111–152, title II, § 2302, Mar. 30,
2010, 124 Stat. 1082; Pub. L. 111–309, title II,
§ 204(a)(1), Dec. 15, 2010, 124 Stat. 3289.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (a)(1),
(3), (4)(L)(i), (5)(A)(i), is act Aug. 14, 1935, ch. 531, 49
Stat. 620, which is classified generally to chapter 7 (§ 301
et seq.) of this title. Titles XVIII and XIX of the Act
are classified generally to subchapters XVIII (§ 1395 et
seq.) and XIX (§ 1396 et seq.) of chapter 7 of this title,
respectively. For complete classification of this Act to
the Code, see section 1305 of this title and Tables.
Section 256a of this title, referred to in subsec.
(a)(4)(B), was in the original a reference to section 340A
of act July 1, 1944, which was repealed by Pub. L.
104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645. Subsequently, a new section 340A was added to the act of
July 1, 1944, by Pub. L. 109–18, § 2, June 29, 2005, 119 Stat.
340, which is also classified to section 256a of this title.
Subpart II of part C of subchapter XXIV of this chapter, referred to in subsec. (a)(4)(D), was redesignated
subpart I of part C of subchapter XXIV of this chapter
by Pub. L. 106–345, title III, § 301(b)(1), Oct. 20, 2000, 114
Stat. 1345, and is classified to section 300ff–51 et seq. of
this title.
The Native Hawaiian Health Care Act of 1988, referred
to in subsec. (a)(4)(H), was Pub. L. 100–579, Oct. 31, 1988,
102 Stat. 2916, and subtitle D of title II of Pub. L.
100–690, Nov. 18, 1988, 102 Stat. 4222, which were classified generally to chapter 122 (§ 11701 et seq.) of this title
prior to being amended generally and renamed the Native Hawaiian Health Care Improvement Act by Pub. L.
102–396. For complete classification of this Act to the
Code, see Tables.
The Indian Health Care Improvement Act, referred to
in subsec. (a)(4)(I), is Pub. L. 94–437, Sept. 30, 1976, 90
Stat. 1400, as amended. Title V of the Act is classified
generally to subchapter IV (§ 1651 et seq.) of chapter 18
of Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables.
Section 247b(j)(2) of this title, referred to in subsec.
(a)(4)(K), was repealed and section 247b(j)(1)(B) was redesignated section 247b(j)(2) by Pub. L. 103–183, title III,
§ 301(b)(1)(A), (C), Dec. 14, 1993, 107 Stat. 2235.
The Prescription Drug Marketing Act, referred to in
subsec. (d)(2)(B)(v)(III), probably means the Prescription Drug Marketing Act of 1987, Pub. L. 100–293, Apr.
22, 1988, 102 Stat. 95, which amended sections 331, 333,
353, and 381 of Title 21, Food and Drugs, and enacted
provisions set out as notes under sections 301 and 353 of
Title 21. For complete classification of this Act to the
Code, see Short Title of 1988 Amendments note set out
under section 301 of Title 21 and Tables.
CODIFICATION
Another section 340B of act July 1, 1944, was renumbered section 340C and is classified to section 256c of
this title.

§ 256b

AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drug’’ for ‘‘covered drug’’
and ‘‘covered outpatient drugs’’ for ‘‘covered drugs’’
wherever appearing.
Pub. L. 111–148, § 7102(b)(1), inserted at end ‘‘Each such
agreement shall require that the manufacturer furnish
the Secretary with reports, on a quarterly basis, of the
price for each covered drug subject to the agreement
that, according to the manufacturer, represents the
maximum price that covered entities may permissibly
be required to pay for the drug (referred to in this section as the ‘ceiling price’), and shall require that the
manufacturer offer each covered entity covered drugs
for purchase at or below the applicable ceiling price if
such drug is made available to any other purchaser at
any price.’’
Subsec. (a)(2)(A). Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drug’’ for ‘‘covered drug’’
in introductory provisions.
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drug’’ for ‘‘covered outpatient drug’’ in introductory
provisions.
Subsec. (a)(2)(B)(i). Pub. L. 111–148, § 2501(f)(1)(A), substituted ‘‘1927(c)(3)’’ for ‘‘1927(c)(4)’’.
Subsec. (a)(4)(L). Pub. L. 111–152, § 2302(1)(B), struck
out ‘‘and’’ at end of cl. (i), substituted ‘‘; and’’ for period at end of cl. (ii), and added cl. (iii).
Pub. L. 111–148, § 7101(c)(1), in cl. (i), inserted ‘‘and’’ at
end, in cl. (ii), substituted period for ‘‘; and’’ at end,
and struck out cl. (iii) which read as follows: ‘‘does not
obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.’’
Subsec. (a)(4)(M) to (O). Pub. L. 111–148, § 7101(a),
added subpars. (M) to (O).
Subsec. (a)(5)(B). Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drug’’ for ‘‘covered drug’’.
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drug’’ for ‘‘covered outpatient drug’’.
Subsec. (a)(5)(C). Pub. L. 111–152, § 2302(1)(C)(i), (ii), redesignated subpar. (D) as (C) and struck out former
subpar. (C). Prior to amendment, text of subpar. (C)
read as follows:
‘‘(i) IN GENERAL.—A hospital described in subparagraph (L), (M), (N), or (O) of paragraph (4) shall not obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement, except as permitted or provided for pursuant to
clauses (ii) or (iii).
‘‘(ii) INPATIENT DRUGS.—Clause (i) shall not apply to
drugs purchased for inpatient use.
‘‘(iii) EXCEPTIONS.—The Secretary shall establish reasonable exceptions to clause (i)—
‘‘(I) with respect to a covered outpatient drug that
is unavailable to be purchased through the program
under this section due to a drug shortage problem,
manufacturer noncompliance, or any other circumstance beyond the hospital’s control;
‘‘(II) to facilitate generic substitution when a generic covered outpatient drug is available at a lower
price; or
‘‘(III) to reduce in other ways the administrative
burdens of managing both inventories of drugs subject to this section and inventories of drugs that are
not subject to this section, so long as the exceptions
do not create a duplicate discount problem in violation of subparagraph (A) or a diversion problem in
violation of subparagraph (B).
‘‘(iv) PURCHASING ARRANGEMENTS FOR INPATIENT
DRUGS.—The Secretary shall ensure that a hospital described in subparagraph (L), (M), (N), or (O) of subsection (a)(4) that is enrolled to participate in the drug
discount program under this section shall have multiple options for purchasing covered outpatient drugs
for inpatients, including by utilizing a group purchasing organization or other group purchasing arrangement, establishing and utilizing its own group purchasing program, purchasing directly from a manufacturer,

§ 256c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and any other purchasing arrangements that the Secretary determines is appropriate to ensure access to
drug discount pricing under this section for inpatient
drugs taking into account the particular needs of small
and rural hospitals.’’
Pub. L. 111–148, § 7101(c)(2)(B), added subpar. (C).
Former subpar. (C) redesignated (D).
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drug’’ for ‘‘covered outpatient drug’’.
Subsec. (a)(5)(C)(iv). Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drugs’’ for ‘‘covered
drugs’’.
Subsec. (a)(5)(D). Pub. L. 111–152, § 2302(1)(C)(ii), (iii),
redesignated subpar. (E) as (D) and substituted ‘‘subparagraph (C)’’ for ‘‘subparagraph (D)’’. Former subpar.
(D) redesignated (C).
Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drug’’ for ‘‘covered drug’’.
Pub. L. 111–148, § 7101(c)(2)(A), redesignated subpar.
(C) as (D). Former subpar. (D) redesignated (E).
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drug’’ for ‘‘covered outpatient drug’’.
Subsec. (a)(5)(E). Pub. L. 111–152, § 2302(1)(C)(ii), redesignated subpar. (E) as (D).
Pub. L. 111–152, § 2302(1)(A), substituted ‘‘covered outpatient drug’’ for ‘‘covered drug’’.
Pub. L. 111–148, §§ 7101(c)(2)(A), 7102(b)(2), redesignated
subpar. (D) as (E) and inserted ‘‘after audit as described
in subparagraph (D) and’’ after ‘‘finds,’’.
Subsec. (a)(7). Pub. L. 111–152, § 2302(1)(A), substituted
‘‘covered outpatient drugs’’ for ‘‘covered drugs’’ wherever appearing.
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drugs’’ for ‘‘covered outpatient drugs’’ wherever appearing.
Subsec. (a)(9). Pub. L. 111–152, § 2302(1)(A), substituted
‘‘covered outpatient drugs’’ for ‘‘covered drugs’’.
Pub. L. 111–148, § 7101(b)(1), substituted ‘‘covered
drugs’’ for ‘‘covered outpatient drugs’’.
Subsec. (b). Pub. L. 111–148, § 7101(b)(2)(A), which directed substitution of ‘‘Other definitions’’ for ‘‘Other
definition’’ in subsec. heading, designation of existing
provisions as par. (1), and insertion of par. (1) heading,
was executed by reenacting subsec. heading without
change, designating existing provisions as par. (1), and
inserting par. (1) heading, to reflect the probable intent
of Congress.
Subsec. (b)(2). Pub. L. 111–148, § 7101(b)(2)(B), added
par. (2).
Subsec. (c). Pub. L. 111–152, § 2302(2), struck out subsec. (c). Text read as follows: ‘‘Not later than 90 days
after the date of filing of the hospital’s most recently
filed Medicare cost report, the hospital shall issue a
credit as determined by the Secretary to the State
Medicaid program for inpatient covered drugs provided
to Medicaid recipients.’’
Pub. L. 111–148, § 7101(d), added subsec. (c) and struck
out former subsec. (c). Prior to amendment, text read
as follows: ‘‘A manufacturer is deemed to meet the requirements of subsection (a) of this section if the manufacturer establishes to the satisfaction of the Secretary that the manufacturer would comply (and has
offered to comply) with the provisions of this section
(as in effect immediately after November 4, 1992), as applied by the Secretary, and would have entered into an
agreement under this section (as such section was in effect at such time), but for a legislative change in this
section (or the application of this section) after November 4, 1992.’’
Pub. L. 111–148, § 2501(f)(1)(B), (C), redesignated subsec. (d) as (c) and struck out former subsec. (c). Text of
former subsec. (c) read as follows: ‘‘Any reference in
this section to a provision of the Social Security Act
shall be deemed to be a reference to the provision as in
effect on November 4, 1992.’’
Subsec. (d). Pub. L. 111–152, § 2302(3), substituted ‘‘covered outpatient drugs’’ for ‘‘covered drugs’’ wherever
appearing and substituted ‘‘(a)(5)(C)’’ for ‘‘(a)(5)(D)’’
and ‘‘(a)(5)(D)’’ for ‘‘(a)(5)(E)’’ in two places.
Pub. L. 111–148, § 7102(a), which directed general
amendment of subsec. (d), was executed by adding sub-

Page 344

sec. (d) after subsec. (c) to reflect the probable intent
of Congress, because no subsec. (d) appeared subsequent
to amendment by Pub. L. 111–148, § 2501(f)(1)(C). See
below.
Pub. L. 111–148, § 2501(f)(1)(C), redesignated subsec. (d)
as (c).
Subsec. (e). Pub. L. 111–309 substituted ‘‘covered entities described in subparagraph (M) (other than a children’s hospital described in subparagraph (M))’’ for
‘‘covered entities described in subparagraph (M)’’.
Pub. L. 111–152, § 2302(4), added subsec. (e).
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–585, § 602(a), which enacted this section.
EFFECTIVE DATE OF 2010 AMENDMENT
Pub. L. 111–309, title II, § 204(a)(2), Dec. 15, 2010, 124
Stat. 3289, provided that: ‘‘The amendment made by
paragraph (1) [amending this section] shall take effect
as if included in the enactment of section 2302 of the
Health Care and Education Reconciliation Act of 2010
(Public Law 111–152).’’
Pub. L. 111–148, title II, § 2501(f)(2), Mar. 23, 2010, 124
Stat. 310, provided that: ‘‘The amendments made by
this subsection [amending this section] take effect on
January 1, 2010.’’
Pub. L. 111–148, title VII, § 7101(e), Mar. 23, 2010, 124
Stat. 823, provided that:
‘‘(1) IN GENERAL.—The amendments made by this section [amending this section] and section 7102 [amending
this section] shall take effect on January 1, 2010, and
shall apply to drugs purchased on or after January 1,
2010.
‘‘(2) EFFECTIVENESS.—The amendments made by this
section and section 7102 shall be effective and shall be
taken into account in determining whether a manufacturer is deemed to meet the requirements of section
340B(a) of the Public Health Service Act (42 U.S.C.
256b(a)), notwithstanding any other provision of law.’’
STUDY OF TREATMENT OF CERTAIN CLINICS AS COVERED
ENTITIES ELIGIBLE FOR PRESCRIPTION DRUG DISCOUNTS
Section 602(b) of Pub. L. 102–585 directed Secretary of
Health and Human Services to conduct a study of feasibility and desirability of including specified entities
receiving funds from a State as covered entities eligible
for limitations on prices of covered outpatient drugs
under 42 U.S.C. 256b(a) and, not later than 1 year after
Nov. 4, 1992, to submit a report to Congress on the
study, including in the report a description of the entities that were the subject of the study, an analysis of
the extent to which such entities procured prescription
drugs, and an analysis of the impact of the inclusion of
such entities as covered entities on the quality of care
provided to and the health status of the patients of
such entities.
SUBPART VIII—BULK PURCHASES OF VACCINES FOR
CERTAIN PROGRAMS

AMENDMENTS
1993—Pub. L. 103–43, title XX, § 2008(i)(2)(A)(i), June
10, 1993, 107 Stat. 213, made technical amendment relating to placement of subpart VIII within part D of this
subchapter.

§ 256c. Bulk purchases of vaccines for certain
programs
(a) Agreements for purchases
(1) In general
Not later than 180 days after October 27, 1992,
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services
Administration, shall enter into negotiations

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with manufacturers of vaccines for the purpose of establishing and maintaining agreements under which entities described in paragraph (2) may purchase vaccines from the
manufacturers at the prices specified in the
agreements.
(2) Relevant entities
The entities referred to in paragraph (1) are
entities that provide immunizations against
vaccine-preventable diseases with assistance
provided under section 254b of this title.
(b) Negotiation of prices
In carrying out subsection (a) of this section,
the Secretary shall, to the extent practicable,
ensure that the prices provided for in agreements under such subsection are comparable to
the prices provided for in agreements negotiated
by the Secretary on behalf of grantees under
section 247b(j)(1) of this title.
(c) Authority of Secretary
In carrying out subsection (a) of this section,
the Secretary, in the discretion of the Secretary, may enter into the agreements described
in such subsection (and may decline to enter
into such agreements), may modify such agreements, may extend such agreements, and may
terminate such agreements.
(d) Rule of construction
This section may not be construed as requiring any State to reduce or terminate the supply
of vaccines provided by the State to any of the
entities described in subsection (a)(2) of this section.
(July 1, 1944, ch. 373, title III, § 340C, formerly
§ 340B, as added Pub. L. 102–531, title III, § 305,
Oct. 27, 1992, 106 Stat. 3494; renumbered § 340C,
Pub. L. 103–43, title XX, § 2008(i)(2)(A)(ii), June
10, 1993, 107 Stat. 213; amended Pub. L. 104–299,
§ 4(a)(2), Oct. 11, 1996, 110 Stat. 3645.)
AMENDMENTS
1996—Subsec. (a)(2). Pub. L. 104–299 substituted ‘‘with
assistance provided under section 254b of this title’’ for
‘‘under the programs established in sections 254b, 254c,
256, and 256a of this title.’’
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–299 effective Oct. 1, 1996,
see section 5 of Pub. L. 104–299, as amended, set out as
a note under section 233 of this title.

§ 256d. Breast and cervical cancer information
(a) In general
As a condition of receiving grants, cooperative
agreements, or contracts under this chapter,
each of the entities specified in subsection (c) of
this section shall, to the extent determined to
be appropriate by the Secretary, make available
information concerning breast and cervical cancer.
(b) Certain authorities
In carrying out subsection (a) of this section,
an entity specified in subsection (c) of this section—
(1) may make the information involved
available to such individuals as the entity determines appropriate;

§ 256d

(2) may, as appropriate, provide information
under subsection (a) of this section on the
need for self-examination of the breasts and on
the skills for such self-examinations;
(3) shall provide information under subsection (a) of this section in the language and
cultural context most appropriate to the individuals to whom the information is provided;
and
(4) shall refer such clients as the entities determine appropriate for breast and cervical
cancer screening, treatment, or other appropriate services.
(c) Relevant entities
The entities specified in this subsection are
the following:
(1) Entities receiving assistance under section 247b–7 1 of this title (relating to tuberculosis).
(2) Entities receiving assistance under section 247c of this title (relating to sexually
transmitted diseases).
(3) Migrant health centers receiving assistance under section 254b 1 of this title.
(4) Community health centers receiving assistance under section 254c 1 of this title.
(5) Entities receiving assistance under section 254b(h) of this title (relating to homeless
individuals).
(6) Entities receiving assistance under section 256a 1 of this title (relating to health services for residents of public housing).
(7) Entities providing services with assistance under subchapter III–A of this chapter or
subchapter XVII of this chapter.
(8) Entities receiving assistance under section 300 of this title (relating to family planning).
(9) Entities receiving assistance under subchapter XXIV of this chapter (relating to services with respect to acquired immune deficiency syndrome).
(10) Non-Federal entities authorized under
the Indian Self-Determination Act [25 U.S.C.
450f et seq.].
(July 1, 1944, ch. 373, title III, § 340D, as added
Pub. L. 103–183, title I, § 104, Dec. 14, 1993, 107
Stat. 2230; amended Pub. L. 106–310, div. A, title
XXV, § 2502(b), Oct. 17, 2000, 114 Stat. 1163; Pub.
L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1664.)
REFERENCES IN TEXT
Section 247b–7 of this title, referred to in subsec.
(c)(1), relates to loan repayment program and not to assistance relating to tuberculosis.
Sections 254b and 254c of this title, referred to in subsec. (c)(3), (4), were in the original references to sections 329 and 330, meaning sections 329 and 330 of act
July 1, 1944, which were omitted in the general amendment of subpart I (§ 254b et seq.) of this part by Pub. L.
104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and
3(a) of Pub. L. 104–299 enacted new sections 330 and 330A
of act July 1, 1944, which are classified, respectively, to
sections 254b and 254c of this title.
Section 256a of this title, referred to in subsec. (c)(6),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.
The Indian Self-Determination Act, referred to in
subsec. (c)(10), is title I of Pub. L. 93–638, Jan. 4, 1975,
1 See

References in Text note below.

§ 256e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

88 Stat. 2206, as amended, which is classified principally
to part A (§ 450f et seq.) of subchapter II of chapter 14
of Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.
AMENDMENTS
2002—Subsec. (c)(5). Pub. L. 107–251 substituted
‘‘254b(h)’’ for ‘‘256’’.
2000—Subsec. (c)(1). Pub. L. 106–310 substituted ‘‘section 247b–7 of this title’’ for ‘‘section 247b–6 of this
title’’.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center, considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
SUBPART IX—SUPPORT OF GRADUATE MEDICAL
EDUCATION PROGRAMS IN CHILDREN’S HOSPITALS

§ 256e. Program of payments to children’s hospitals that operate graduate medical education programs
(a) Payments
The Secretary shall make two payments under
this section to each children’s hospital for each
of fiscal years 2000 through 2005 and each of fiscal years 2007 through 2011, one for the direct expenses and the other for indirect expenses associated with operating approved graduate medical residency training programs. The Secretary
shall promulgate regulations pursuant to the
rulemaking requirements of title 5 which shall
govern payments made under this subpart.
(b) Amount of payments
(1) In general
Subject to paragraphs (2) and (3), the
amounts payable under this section to a children’s hospital for an approved graduate medical residency training program for a fiscal
year are each of the following amounts:
(A) Direct expense amount
The amount determined under subsection
(c) of this section for direct expenses associated with operating approved graduate medical residency training programs.
(B) Indirect expense amount
The amount determined under subsection
(d) of this section for indirect expenses associated with the treatment of more severely
ill patients and the additional costs relating
to teaching residents in such programs.
(2) Capped amount
(A) In general
The total of the payments made to children’s hospitals under paragraph (1)(A) or
paragraph (1)(B) in a fiscal year shall not exceed the funds appropriated under paragraph
(1) or (2), respectively, of subsection (f) of
this section for such payments for that fiscal
year.
(B) Pro rata reductions of payments for direct expenses
If the Secretary determines that the
amount of funds appropriated under sub-

Page 346

section (f)(1) of this section for a fiscal year
is insufficient to provide the total amount of
payments otherwise due for such periods
under paragraph (1)(A), the Secretary shall
reduce the amounts so payable on a pro rata
basis to reflect such shortfall.
(3) Annual reporting required
(A) Reduction in payment for failure to report
(i) In general
The amount payable under this section
to a children’s hospital for a fiscal year
(beginning with fiscal year 2008 and after
taking into account paragraph (2)) shall be
reduced by 25 percent if the Secretary determines that—
(I) the hospital has failed to provide
the Secretary, as an addendum to the
hospital’s application under this section
for such fiscal year, the report required
under subparagraph (B) for the previous
fiscal year; or
(II) such report fails to provide the information required under any clause of
such subparagraph.
(ii) Notice and opportunity to provide missing information
Before imposing a reduction under
clause (i) on the basis of a hospital’s failure to provide information described in
clause (i)(II), the Secretary shall provide
notice to the hospital of such failure and
the Secretary’s intention to impose such
reduction and shall provide the hospital
with the opportunity to provide the required information within a period of 30
days beginning on the date of such notice.
If the hospital provides such information
within such period, no reduction shall be
made under clause (i) on the basis of the
previous failure to provide such information.
(B) Annual report
The report required under this subparagraph for a children’s hospital for a fiscal
year is a report that includes (in a form and
manner specified by the Secretary) the following information for the residency academic year completed immediately prior to
such fiscal year:
(i) The types of resident training programs that the hospital provided for residents described in subparagraph (C), such
as general pediatrics, internal medicine/pediatrics, and pediatric subspecialties, including both medical subspecialties certified by the American Board of Pediatrics
(such as pediatric gastroenterology) and
non-medical subspecialties approved by
other medical certification boards (such as
pediatric surgery).
(ii) The number of training positions for
residents described in subparagraph (C),
the number of such positions recruited to
fill, and the number of such positions
filled.
(iii) The types of training that the hospital provided for residents described in

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subparagraph (C) related to the health
care needs of different populations, such as
children who are underserved for reasons
of family income or geographic location,
including rural and urban areas.
(iv) The changes in residency training
for residents described in subparagraph (C)
which the hospital has made during such
residency academic year (except that the
first report submitted by the hospital
under this subparagraph shall be for such
changes since the first year in which the
hospital received payment under this section), including—
(I) changes in curricula, training experiences, and types of training programs,
and benefits that have resulted from
such changes; and
(II) changes for purposes of training
the residents in the measurement and
improvement of the quality and safety of
patient care.
(v) The numbers of residents described in
subparagraph (C) who completed their residency training at the end of such residency
academic year and care for children within
the borders of the service area of the hospital or within the borders of the State in
which the hospital is located. Such numbers shall be disaggregated with respect to
residents who completed residencies in
general pediatrics or internal medicine/pediatrics, subspecialty residencies, and dental residencies.
(C) Residents
The residents described in this subparagraph are those who—
(i) are in full-time equivalent resident
training positions in any training program
sponsored by the hospital; or
(ii) are in a training program sponsored
by an entity other than the hospital, but
who spend more than 75 percent of their
training time at the hospital.
(D) Report to Congress
Not later than the end of fiscal year 2011,
the Secretary, acting through the Administrator of the Health Resources and Services
Administration, shall submit a report to the
Congress—
(i) summarizing the information submitted in reports to the Secretary under subparagraph (B);
(ii) describing the results of the program
carried out under this section; and
(iii) making recommendations for improvements to the program.
(c) Amount of payment for direct graduate medical education
(1) In general
The amount determined under this subsection for payments to a children’s hospital
for direct graduate expenses relating to approved graduate medical residency training
programs for a fiscal year is equal to the product of—
(A) the updated per resident amount for direct graduate medical education, as determined under paragraph (2); and

§ 256e

(B) the average number of full-time equivalent residents in the hospital’s graduate approved medical residency training programs
(as determined under section 1395ww(h)(4) of
this title during the fiscal year.
(2) Updated per resident amount for direct
graduate medical education
The updated per resident amount for direct
graduate medical education for a hospital for
a fiscal year is an amount determined as follows:
(A) Determination of hospital single per resident amount
The Secretary shall compute for each hospital operating an approved graduate medical education program (regardless of whether or not it is a children’s hospital) a single
per resident amount equal to the average
(weighted by number of full-time equivalent
residents) of the primary care per resident
amount and the non-primary care per resident amount computed under section
1395ww(h)(2) of this title for cost reporting
periods ending during fiscal year 1997.
(B) Determination of wage and non-wage-related proportion of the single per resident amount
The Secretary shall estimate the average
proportion of the single per resident
amounts computed under subparagraph (A)
that is attributable to wages and wage-related costs.
(C) Standardizing per resident amounts
The Secretary shall establish a standardized per resident amount for each such hospital—
(i) by dividing the single per resident
amount computed under subparagraph (A)
into a wage-related portion and a nonwage-related portion by applying the proportion determined under subparagraph
(B);
(ii) by dividing the wage-related portion
by the factor applied under section
1395ww(d)(3)(E) of this title for discharges
occurring during fiscal year 1999 for the
hospital’s area; and
(iii) by adding the non-wage-related portion to the amount computed under clause
(ii).
(D) Determination of national average
The Secretary shall compute a national
average per resident amount equal to the average of the standardized per resident
amounts computed under subparagraph (C)
for such hospitals, with the amount for each
hospital weighted by the average number of
full-time equivalent residents at such hospital.
(E) Application to individual hospitals
The Secretary shall compute for each such
hospital that is a children’s hospital a per
resident amount—
(i) by dividing the national average per
resident amount computed under subparagraph (D) into a wage-related portion and
a non-wage-related portion by applying

§ 256e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the proportion determined under subparagraph (B);
(ii) by multiplying the wage-related portion by the factor applied under section
1395ww(d)(3)(E) of this title for discharges
occurring during the preceding fiscal year
for the hospital’s area; and
(iii) by adding the non-wage-related portion to the amount computed under clause
(ii).
(F) Updating rate
The Secretary shall update such per resident amount for each such children’s hospital by the estimated percentage increase
in the consumer price index for all urban
consumers during the period beginning October 1997 and ending with the midpoint of the
Federal fiscal year for which payments are
made.
(d) Amount of payment for indirect medical education
(1) In general
The amount determined under this subsection for payments to a children’s hospital
for indirect expenses associated with the
treatment of more severely ill patients and
the additional costs associated with the teaching of residents for a fiscal year is equal to an
amount determined appropriate by the Secretary.
(2) Factors
In determining the amount under paragraph
(1), the Secretary shall—
(A) take into account variations in case
mix among children’s hospitals and the ratio
of the number of full-time equivalent residents in the hospitals’ approved graduate
medical residency training programs to beds
(but excluding beds or bassinets assigned to
healthy newborn infants); and
(B) assure that the aggregate of the payments for indirect expenses associated with
the treatment of more severely ill patients
and the additional costs related to the
teaching of residents under this section in a
fiscal year are equal to the amount appropriated for such expenses for the fiscal year
involved under subsection (f)(2) of this section.
(e) Making of payments
(1) Interim payments
The Secretary shall determine, before the
beginning of each fiscal year involved for
which payments may be made for a hospital
under this section, the amounts of the payments for direct graduate medical education
and indirect medical education for such fiscal
year and shall (subject to paragraph (2)) make
the payments of such amounts in 12 equal interim installments during such period. Such
interim payments to each individual hospital
shall be based on the number of residents reported in the hospital’s most recently filed
Medicare cost report prior to the application
date for the Federal fiscal year for which the
interim payment amounts are established. In
the case of a hospital that does not report residents on a Medicare cost report, such interim

Page 348

payments shall be based on the number of residents trained during the hospital’s most recently completed Medicare cost report filing
period.
(2) Withholding
The Secretary shall withhold up to 25 percent from each interim installment for direct
and indirect graduate medical education paid
under paragraph (1) as necessary to ensure a
hospital will not be overpaid on an interim
basis.
(3) Reconciliation
Prior to the end of each fiscal year, the Secretary shall determine any changes to the
number of residents reported by a hospital in
the application of the hospital for the current
fiscal year to determine the final amount payable to the hospital for the current fiscal year
for both direct expense and indirect expense
amounts. Based on such determination, the
Secretary shall recoup any overpayments
made and pay any balance due to the extent
possible. The final amount so determined shall
be considered a final intermediary determination for the purposes of section 1395oo of this
title and shall be subject to administrative
and judicial review under that section in the
same manner as the amount of payment under
section 1395ww(d) 1 of this title is subject to review under such section.
(f) Authorization of appropriations
(1) Direct graduate medical education
(A) In general
There are hereby authorized to be appropriated, out of any money in the Treasury
not otherwise appropriated, for payments
under subsection (b)(1)(A) of this section—
(i) for fiscal year 2000, $90,000,000;
(ii) for fiscal year 2001, $95,000,000;
(iii) for each of the fiscal years 2002
through 2005, such sums as may be necessary; and
(iv) for each of fiscal years 2007 through
2011, $110,000,000.
(B) Carryover of excess
The amounts appropriated under subparagraph (A) for fiscal year 2000 shall remain
available for obligation through the end of
fiscal year 2001.
(2) Indirect medical education
There are hereby authorized to be appropriated, out of any money in the Treasury not
otherwise appropriated, for payments under
subsection (b)(1)(B) of this section—
(A) for fiscal year 2000, $190,000,000;
(B) for fiscal year 2001, $190,000,000;
(C) for each of the fiscal years 2002 through
2005, such sums as may be necessary; and
(D) for each of fiscal years 2007 through
2011, $220,000,000.
(g) Definitions
In this section:
(1) Approved graduate medical residency training program
The term ‘‘approved graduate medical residency training program’’ has the meaning
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

given the term ‘‘approved medical residency
training program’’ in section 1395ww(h)(5)(A)
of this title.
(2) Children’s hospital
The term ‘‘children’s hospital’’ means a hospital with a Medicare payment agreement and
which is excluded from the Medicare inpatient
prospective payment system pursuant to section 1395ww(d)(1)(B)(iii) of this title and its accompanying regulations.
(3) Direct graduate medical education costs
The term ‘‘direct graduate medical education costs’’ has the meaning given such term
in section 1395ww(h)(5)(C) of this title.
(July 1, 1944, ch. 373, title III, § 340E, as added
Pub. L. 106–129, § 4, Dec. 6, 1999, 113 Stat. 1671;
amended Pub. L. 106–310, div. A, title XX, § 2001,
Oct. 17, 2000, 114 Stat. 1155; Pub. L. 108–490, § 1(a),
Dec. 23, 2004, 118 Stat. 3972; Pub. L. 109–307, § 2,
Oct. 6, 2006, 120 Stat. 1721.)
REFERENCES IN TEXT
Section 1395ww(d) of this title, referred to in subsec.
(e)(3), was in the original ‘‘section 1186(d) of such Act’’
and was translated as reading ‘‘section 1886(d) of such
Act’’, meaning section 1886(d) of the Social Security
Act, to reflect the probable intent of Congress, because
the Social Security Act does not contain a section 1186
and section 1395ww(d) of this title relates to review of
inpatient hospital service payments.
AMENDMENTS
2006—Subsec. (a). Pub. L. 109–307, § 2(a)(1), inserted
‘‘and each of fiscal years 2007 through 2011’’ after ‘‘for
each of fiscal years 2000 through 2005’’.
Subsec. (b)(1). Pub. L. 109–307, § 2(b)(1), substituted
‘‘paragraphs (2) and (3)’’ for ‘‘paragraph (2)’’ in introductory provisions.
Subsec. (b)(3). Pub. L. 109–307, § 2(b)(2), added par. (3).
Subsec. (c)(2)(E)(ii). Pub. L. 109–307, § 2(c)(1), substituted ‘‘applied under section 1395ww(d)(3)(E) of this
title for discharges occurring during the preceding fiscal year’’ for ‘‘described in subparagraph (C)(ii)’’.
Subsec. (e)(1). Pub. L. 109–307, § 2(a)(2), substituted
‘‘12’’ for ‘‘26’’.
Subsec. (e)(2). Pub. L. 109–307, § 2(c)(2), struck out first
sentence which read as follows: ‘‘The Secretary shall
withhold up to 25 percent from each interim installment for direct and indirect graduate medical education paid under paragraph (1).’’
Subsec. (e)(3). Pub. L. 109–307, § 2(c)(3), substituted
‘‘made and pay’’ for ‘‘made to pay’’.
Subsec. (f)(1)(A)(iv). Pub. L. 109–307, § 2(a)(3), added cl.
(iv).
Subsec. (f)(2). Pub. L. 109–307, § 2(a)(4)(A), substituted
‘‘subsection (b)(1)(B)’’ for ‘‘subsection (b)(1)(A)’’ in introductory provisions.
Subsec. (f)(2)(D). Pub. L. 109–307, § 2(a)(4)(B)–(D),
added subpar. (D).
2004—Subsec. (d)(1). Pub. L. 108–490, § 1(a)(1), substituted ‘‘costs associated with’’ for ‘‘costs related to’’.
Subsec. (d)(2)(A). Pub. L. 108–490, § 1(a)(2), inserted
‘‘ratio of the’’ after ‘‘hospitals and the’’ and ‘‘to beds
(but excluding beds or bassinets assigned to healthy
newborn infants)’’ before semicolon.
2000—Subsec. (a). Pub. L. 106–310, § 2001(a), substituted
‘‘2000 through 2005’’ for ‘‘2000 and 2001’’ and inserted at
end ‘‘The Secretary shall promulgate regulations pursuant to the rulemaking requirements of title 5 which
shall govern payments made under this subpart.’’.
Subsec. (c)(2)(F). Pub. L. 106–310, § 2001(b), substituted
‘‘Federal fiscal year for which payments are made’’ for
‘‘hospital’s cost reporting period that begins during fiscal year 2000’’.
Subsec. (e)(1). Pub. L. 106–310, § 2001(c), inserted at end
‘‘Such interim payments to each individual hospital

§ 256g

shall be based on the number of residents reported in
the hospital’s most recently filed Medicare cost report
prior to the application date for the Federal fiscal year
for which the interim payment amounts are established. In the case of a hospital that does not report
residents on a Medicare cost report, such interim payments shall be based on the number of residents trained
during the hospital’s most recently completed Medicare cost report filing period.’’
Subsec. (e)(2). Pub. L. 106–310, § 2001(d), inserted ‘‘and
indirect’’ after ‘‘interim installment for direct’’ and inserted at end ‘‘The Secretary shall withhold up to 25
percent from each interim installment for direct and
indirect graduate medical education paid under paragraph (1) as necessary to ensure a hospital will not be
overpaid on an interim basis.’’
Subsec. (e)(3). Pub. L. 106–310, § 2001(e), reenacted
heading without change and amended text generally.
Prior to amendment, text read as follows: ‘‘At the end
of each fiscal year for which payments may be made
under this section, the hospital shall submit to the Secretary such information as the Secretary determines to
be necessary to determine the percent (if any) of the
total amount withheld under paragraph (2) that is due
under this section for the hospital for the fiscal year.
Based on such determination, the Secretary shall recoup any overpayments made, or pay any balance due.
The amount so determined shall be considered a final
intermediary determination for purposes of applying
section 1395oo of this title and shall be subject to review under that section in the same manner as the
amount of payment under section 1395ww(d) of this
title is subject to review under such section.’’
Subsec. (f)(1)(A)(iii). Pub. L. 106–310, § 2001(f)(1), added
cl. (iii).
Subsec. (f)(2)(C). Pub. L. 106–310, § 2001(f)(2), added subpar. (C).
Subsec. (g)(2). Pub. L. 106–310, § 2001(g), substituted
‘‘with a Medicare payment agreement and which is excluded from the Medicare inpatient prospective payment system pursuant to section 1395ww(d)(1)(B)(iii) of
this title and its accompanying regulations’’ for ‘‘described in section 1395ww(d)(1)(B)(iii) of this title’’.
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108–490, § 1(b), Dec. 23, 2004, 118 Stat. 3972, provided that: ‘‘The amendments made by subsection (a)
[amending this section] shall apply to payments for periods beginning with fiscal year 2005.’’
SUBPART X—PRIMARY DENTAL PROGRAMS

§ 256f. Designated dental health professional
shortage area
In this subpart, the term ‘‘designated dental
health professional shortage area’’ means an
area, population group, or facility that is designated by the Secretary as a dental health professional shortage area under section 254e of this
title or designated by the applicable State as
having a dental health professional shortage.
(July 1, 1944, ch. 373, title III, § 340F, as added
Pub. L. 107–251, title IV, § 403, Oct. 26, 2002, 116
Stat. 1660.)
§ 256g. Grants for innovative programs
(a) Grant program authorized
The Secretary, acting through the Administrator of the Health Resources and Services Administration, is authorized to award grants to
States for the purpose of helping States develop
and implement innovative programs to address
the dental workforce needs of designated dental
health professional shortage areas in a manner
that is appropriate to the States’ individual
needs.

§ 256g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) State activities
A State receiving a grant under subsection (a)
of this section may use funds received under the
grant for—
(1) loan forgiveness and repayment programs
for dentists who—
(A) agree to practice in designated dental
health professional shortage areas;
(B) are dental school graduates who agree
to serve as public health dentists for the
Federal, State, or local government; and
(C) agree to—
(i) provide services to patients regardless
of such patients’ ability to pay; and
(ii) use a sliding payment scale for patients who are unable to pay the total cost
of services;
(2) dental recruitment and retention efforts;
(3) grants and low-interest or no-interest
loans to help dentists who participate in the
medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) to establish or expand practices in designated dental health professional shortage areas by
equipping dental offices or sharing in the overhead costs of such practices;
(4) the establishment or expansion of dental
residency programs in coordination with accredited dental training institutions in States
without dental schools;
(5) programs developed in consultation with
State and local dental societies to expand or
establish oral health services and facilities in
designated dental health professional shortage
areas, including services and facilities for children with special needs, such as—
(A) the expansion or establishment of a
community-based dental facility, free-standing dental clinic, consolidated health center
dental facility, school-linked dental facility,
or United States dental school-based facility;
(B) the establishment of a mobile or portable dental clinic; and
(C) the establishment or expansion of private dental services to enhance capacity
through additional equipment or additional
hours of operation;
(6) placement and support of dental students,
dental residents, and advanced dentistry
trainees;
(7) continuing dental education, including
distance-based education;
(8) practice support through teledentistry
conducted in accordance with State laws;
(9) community-based prevention services
such as water fluoridation and dental sealant
programs;
(10) coordination with local educational
agencies within the State to foster programs
that promote children going into oral health
or science professions;
(11) the establishment of faculty recruitment programs at accredited dental training
institutions whose mission includes community outreach and service and that have a
demonstrated record of serving underserved
States;
(12) the development of a State dental officer
position or the augmentation of a State dental

Page 350

office to coordinate oral health and access issues in the State; and
(13) any other activities determined to be appropriate by the Secretary.
(c) Application
(1) In general
Each State desiring a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary
may reasonably require.
(2) Assurances
The application shall include assurances
that the State will meet the requirements of
subsection (d) of this section and that the
State possesses sufficient infrastructure to
manage the activities to be funded through
the grant and to evaluate and report on the
outcomes resulting from such activities.
(d) Matching requirement
The Secretary may not make a grant to a
State under this section unless that State
agrees that, with respect to the costs to be incurred by the State in carrying out the activities for which the grant was awarded, the State
will provide non-Federal contributions in an
amount equal to not less than 40 percent of Federal funds provided under the grant. The State
may provide the contributions in cash or in
kind, fairly evaluated, including plant, equipment, and services and may provide the contributions from State, local, or private sources.
(e) Report
Not later than 5 years after October 26, 2002,
the Secretary shall prepare and submit to the
appropriate committees of Congress a report
containing data relating to whether grants provided under this section have increased access to
dental services in designated dental health professional shortage areas.
(f) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $25,000,000 for the 5-fiscal
year period beginning with fiscal year 2008.
(July 1, 1944, ch. 373, title III, § 340G, as added
Pub. L. 107–251, title IV, § 403, Oct. 26, 2002, 116
Stat. 1661; amended Pub. L. 110–355, § 5, Oct. 8,
2008, 122 Stat. 3994.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(3),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Title XIX of the Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
AMENDMENTS
2008—Subsec. (f). Pub. L. 110–355 substituted
‘‘$25,000,000’’ for ‘‘$50,000,000’’ and ‘‘2008’’ for ‘‘2002’’.

§ 256g–1. Demonstration program to increase access to dental health care services
(a) In general
(1) Authorization
The Secretary is authorized to award grants
to 15 eligible entities to enable such entities

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

to establish a demonstration program to establish training programs to train, or to employ, alternative dental health care providers
in order to increase access to dental health
care services in rural and other underserved
communities.
(2) Definition
The term ‘‘alternative dental health care
providers’’ includes community dental health
coordinators, advance practice dental hygienists, independent dental hygienists, supervised
dental hygienists, primary care physicians,
dental therapists, dental health aides, and any
other health professional that the Secretary
determines appropriate.
(b) Timeframe
The demonstration projects funded under this
section shall begin not later than 2 years after
March 23, 2010, and shall conclude not later than
7 years after March 23, 2010.
(c) Eligible entities
To be eligible to receive a grant under subsection (a), an entity shall—
(1) be—
(A) an institution of higher education, including a community college;
(B) a public-private partnership;
(C) a federally qualified health center;
(D) an Indian Health Service facility or a
tribe or tribal organization (as such terms
are defined in section 450b of title 25);
(E) a State or county public health clinic,
a health facility operated by an Indian tribe
or tribal organization, or urban Indian organization providing dental services; or
(F) a public hospital or health system;
(2) be within a program accredited by the
Commission on Dental Accreditation or within
a dental education program in an accredited
institution; and
(3) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary
may require.
(d) Administrative provisions
(1) Amount of grant
Each grant under this section shall be in an
amount that is not less than $4,000,000 for the
5-year period during which the demonstration
project 1 being conducted.
(2) Disbursement of funds
(A) Preliminary disbursements
Beginning 1 year after March 23, 2010, the
Secretary may disperse to any entity receiving a grant under this section not more than
20 percent of the total funding awarded to
such entity under such grant, for the purpose of enabling the entity to plan the demonstration project to be conducted under
such grant.
(B) Subsequent disbursements
The remaining amount of grant funds not
dispersed under subparagraph (A) shall be
dispersed such that not less than 15 percent
1 So

in original. The word ‘‘is’’ probably should appear.

§ 256h

of such remaining amount is dispersed each
subsequent year.
(e) Compliance with State requirements
Each entity receiving a grant under this section shall certify that it is in compliance with
all applicable State licensing requirements.
(f) Evaluation
The Secretary shall contract with the Director of the Institute of Medicine to conduct a
study of the demonstration programs conducted
under this section that shall provide analysis,
based upon quantitative and qualitative data,
regarding access to dental health care in the
United States.
(g) Clarification regarding dental health aide
program
Nothing in this section shall prohibit a dental
health aide training program approved by the
Indian Health Service from being eligible for a
grant under this section.
(h) Authorization of appropriations
There is authorized to be appropriated such
sums as may be necessary to carry out this section.
(July 1, 1944, ch. 373, title III, § 340G–1, as added
Pub. L. 111–148, title V, § 5304, Mar. 23, 2010, 124
Stat. 621.)
SUBPART XI—SUPPORT OF GRADUATE MEDICAL
EDUCATION IN QUALIFIED TEACHING HEALTH
CENTERS

CODIFICATION
Subpart is comprised of subpart XI of part D of title
III of act July 1, 1944, as added by Pub. L. 111–148, title
V, § 5508(c), Mar. 23, 2010, 124 Stat. 670. Another subpart
XI of part D of title III of the Act was added by Pub.
L. 111–148, title X, § 10333, Mar. 23, 2010, 124 Stat. 970, and
is classified to subpart XII (§ 256i) of this part.

§ 256h. Program of payments to teaching health
centers that operate graduate medical education programs
(a) Payments
Subject to subsection (h)(2), the Secretary
shall make payments under this section for direct expenses and for indirect expenses to qualified teaching health centers that are listed as
sponsoring institutions by the relevant accrediting body for expansion of existing or establishment of new approved graduate medical residency training programs.
(b) Amount of payments
(1) In general
Subject to paragraph (2), the amounts payable under this section to qualified teaching
health centers for an approved graduate medical residency training program for a fiscal
year are each of the following amounts:
(A) Direct expense amount
The amount determined under subsection
(c) for direct expenses associated with sponsoring approved graduate medical residency
training programs.
(B) Indirect expense amount
The amount determined under subsection
(d) for indirect expenses associated with the

§ 256h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

additional costs relating to teaching residents in such programs.
(2) Capped amount
(A) In general
The total of the payments made to qualified teaching health centers under paragraph
(1)(A) or paragraph (1)(B) in a fiscal year
shall not exceed the amount of funds appropriated under subsection (g) for such payments for that fiscal year.
(B) Limitation
The Secretary shall limit the funding of
full-time equivalent residents in order to ensure the direct and indirect payments as determined under subsection 1 (c) and (d) do
not exceed the total amount of funds appropriated in a fiscal year under subsection (g).
(c) Amount of payment for direct graduate medical education
(1) In general
The amount determined under this subsection for payments to qualified teaching
health centers for direct graduate expenses relating to approved graduate medical residency
training programs for a fiscal year is equal to
the product of—
(A) the updated national per resident
amount for direct graduate medical education, as determined under paragraph (2);
and
(B) the average number of full-time equivalent residents in the teaching health center’s graduate approved medical residency
training programs as determined under section 1395ww(h)(4) of this title (without regard to the limitation under subparagraph
(F) of such section) during the fiscal year.
(2) Updated national per resident amount for
direct graduate medical education
The updated per resident amount for direct
graduate medical education for a qualified
teaching health center for a fiscal year is an
amount determined as follows:
(A) Determination of qualified teaching
health center per resident amount
The Secretary shall compute for each individual qualified teaching health center a per
resident amount—
(i) by dividing the national average per
resident amount computed under section
256e(c)(2)(D) of this title into a wage-related portion and a non-wage related portion
by applying the proportion determined
under subparagraph (B);
(ii) by multiplying the wage-related portion by the factor applied under section
1395ww(d)(3)(E) of this title (but without
application of section 4410 of the Balanced
Budget Act of 1997 (42 U.S.C. 1395ww note))
during the preceding fiscal year for the
teaching health center’s area; and
(iii) by adding the non-wage-related portion to the amount computed under clause
(ii).
(B) Updating rate
The Secretary shall update such per resident amount for each such qualified teach1 So

in original. Probably should be ‘‘subsections’’.

Page 352

ing health center as determined appropriate
by the Secretary.
(d) Amount of payment for indirect medical education
(1) In general
The amount determined under this subsection for payments to qualified teaching
health centers for indirect expenses associated
with the additional costs of teaching residents
for a fiscal year is equal to an amount determined appropriate by the Secretary.
(2) Factors
In determining the amount under paragraph
(1), the Secretary shall—
(A) evaluate indirect training costs relative to supporting a primary care residency
program in qualified teaching health centers; and
(B) based on this evaluation, assure that
the aggregate of the payments for indirect
expenses under this section and the payments for direct graduate medical education
as determined under subsection (c) in a fiscal year do not exceed the amount appropriated for such expenses as determined in
subsection (g).
(3) Interim payment
Before the Secretary makes a payment
under this subsection pursuant to a determination of indirect expenses under paragraph
(1), the Secretary may provide to qualified
teaching health centers a payment, in addition to any payment made under subsection
(c), for expected indirect expenses associated
with the additional costs of teaching residents
for a fiscal year, based on an estimate by the
Secretary.
(e) Clarification regarding relationship to other
payments for graduate medical education
Payments under this section—
(1) shall be in addition to any payments—
(A) for the indirect costs of medical education under section 1395ww(d)(5)(B) of this
title;
(B) for direct graduate medical education
costs under section 1395ww(h) of this title;
and
(C) for direct costs of medical education
under section 1395ww(k) of this title;
(2) shall not be taken into account in applying the limitation on the number of total fulltime equivalent residents under subparagraphs
(F) and (G) of section 1395ww(h)(4) of this title
and clauses (v), (vi)(I), and (vi)(II) of section
1395ww(d)(5)(B) of this title for the portion of
time that a resident rotates to a hospital; and
(3) shall not include the time in which a resident is counted toward full-time equivalency
by a hospital under paragraph (2) or under section 1395ww(d)(5)(B)(iv) of this title, section
1395ww(h)(4)(E) of this title, or section 256e of
this title.
(f) Reconciliation
The Secretary shall determine any changes to
the number of residents reported by a hospital
in the application of the hospital for the current
fiscal year to determine the final amount pay-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

able to the hospital for the current fiscal year
for both direct expense and indirect expense
amounts. Based on such determination, the Secretary shall recoup any overpayments made to
pay any balance due to the extent possible. The
final amount so determined shall be considered
a final intermediary determination for the purposes of section 1395oo of this title and shall be
subject to administrative and judicial review
under that section in the same manner as the
amount of payment under section 1395ww(d) 2 of
this title is subject to review under such section.
(g) Funding
To carry out this section, there are appropriated such sums as may be necessary, not to
exceed $230,000,000, for the period of fiscal years
2011 through 2015.
(h) Annual reporting required
(1) Annual report
The report required under this paragraph for
a qualified teaching health center for a fiscal
year is a report that includes (in a form and
manner specified by the Secretary) the following information for the residency academic
year completed immediately prior to such fiscal year:
(A) The types of primary care resident approved training programs that the qualified
teaching health center provided for residents.
(B) The number of approved training positions for residents described in paragraph
(4).
(C) The number of residents described in
paragraph (4) who completed their residency
training at the end of such residency academic year and care for vulnerable populations living in underserved areas.
(D) Other information as deemed appropriate by the Secretary.
(2) Audit authority; limitation on payment
(A) Audit authority
The Secretary may audit a qualified teaching health center to ensure the accuracy and
completeness of the information submitted
in a report under paragraph (1).
(B) Limitation on payment
A teaching health center may only receive
payment in a cost reporting period for a
number of such resident positions that is
greater than the base level of primary care
resident positions, as determined by the Secretary. For purposes of this subparagraph,
the ‘‘base level of primary care residents’’
for a teaching health center is the level of
such residents as of a base period.
(3) Reduction in payment for failure to report
(A) In general
The amount payable under this section to
a qualified teaching health center for a fiscal year shall be reduced by at least 25 percent if the Secretary determines that—
(i) the qualified teaching health center
has failed to provide the Secretary, as an
2 See

References in Text note below.

§ 256h

addendum to the qualified teaching health
center’s application under this section for
such fiscal year, the report required under
paragraph (1) for the previous fiscal year;
or
(ii) such report fails to provide complete
and accurate information required under
any subparagraph of such paragraph.
(B) Notice and opportunity to provide accurate and missing information
Before imposing a reduction under subparagraph (A) on the basis of a qualified
teaching health center’s failure to provide
complete and accurate information described in subparagraph (A)(ii), the Secretary shall provide notice to the teaching
health center of such failure and the Secretary’s intention to impose such reduction
and shall provide the teaching health center
with the opportunity to provide the required
information within the period of 30 days beginning on the date of such notice. If the
teaching health center provides such information within such period, no reduction
shall be made under subparagraph (A) on the
basis of the previous failure to provide such
information.
(4) Residents
The residents described in this paragraph
are those who are in part-time or full-time
equivalent resident training positions at a
qualified teaching health center in any approved graduate medical residency training
program.
(i) Regulations
The Secretary shall promulgate regulations to
carry out this section.
(j) Definitions
In this section:
(1) Approved graduate medical residency training program
The term ‘‘approved graduate medical residency training program’’ means a residency or
other postgraduate medical training program—
(A) participation in which may be counted
toward certification in a specialty or subspecialty and includes formal postgraduate
training programs in geriatric medicine approved by the Secretary; and
(B) that meets criteria for accreditation
(as established by the Accreditation Council
for Graduate Medical Education, the American Osteopathic Association, or the American Dental Association).
(2) Primary care residency program
The term ‘‘primary care residency program’’
has the meaning given that term in section
293l–1 of this title.
(3) Qualified teaching health center
The term ‘‘qualified teaching health center’’
has the meaning given the term ‘‘teaching
health center’’ in section 293l–1 of this title.
(July 1, 1944, ch. 373, title III, § 340H, as added
Pub. L. 111–148, title V, § 5508(c), Mar. 23, 2010, 124
Stat. 670.)

§ 256i

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

Section 4410 of the Balanced Budget Act of 1997, referred to in subsec. (c)(2)(A)(ii), is section 4410 of Pub.
L. 105–33, which is set out as a note under section
1395ww of this title.
Section 1395ww(d) of this title, referred to in subsec.
(f), was in the original ‘‘section 1186(d) of such Act’’,
and was translated as meaning section 1886(d) of act
Aug. 14, 1935, ch. 531, known as the Social Security Act,
to reflect the probable intent of Congress. The Social
Security Act does not contain a section 1186.
CODIFICATION
Another section 340H of act July 1, 1944, ch. 373, as
added by Pub. L. 111–148, title X, § 10333, March 23, 2010,
124 Stat. 970, is classified to section 256i of this title.
SUBPART XII—COMMUNITY-BASED COLLABORATIVE
CARE NETWORK PROGRAM

CODIFICATION
Subpart is comprised of subpart XI of part D of title
III of act July 1, 1944, as added by Pub. L. 111–148, title
X, § 10333, Mar. 23, 2010, 124 Stat. 970. Another subpart
XI of part D of title III of the Act was added by Pub.
L. 111–148, title V, § 5508(c), Mar. 23, 2010, 124 Stat. 670,
and is classified to subpart XI (§ 256h) of this part.

§ 256i. Community-based collaborative care network program
(a) In general
The Secretary may award grants to eligible
entities to support community-based collaborative care networks that meet the requirements of subsection (b).
(b) Community-based collaborative care networks
(1) Description
A community-based collaborative care network (referred to in this section as a ‘‘network’’) shall be a consortium of health care
providers with a joint governance structure
(including providers within a single entity)
that provides comprehensive coordinated and
integrated health care services (as defined by
the Secretary) for low-income populations.
(2) Required inclusion
A network shall include the following providers (unless such provider does not exist
within the community, declines or refuses to
participate, or places unreasonable conditions
on their participation):
(A) A hospital that meets the criteria in
section 1396r–4(b)(1) of this title; and
(B) All Federally qualified health centers
(as defined in section 1395x(aa) of this title 1
located in the community.
(3) Priority
In awarding grants, the Secretary shall give
priority to networks that include—
(A) the capability to provide the broadest
range of services to low-income individuals;
(B) the broadest range of providers that
currently serve a high volume of low-income
individuals; and
(C) a county or municipal department of
health.
1 So

in original. A closing parenthesis probably should appear.

Page 354

(c) Application
(1) Application
A network described in subsection (b) shall
submit an application to the Secretary.
(2) Renewal
In subsequent years, based on the performance of grantees, the Secretary may provide
renewal grants to prior year grant recipients.
(d) Use of funds
(1) Use by grantees
Grant funds may be used for the following
activities:
(A) Assist low-income individuals to—
(i) access and appropriately use health
services;
(ii) enroll in health coverage programs;
and
(iii) obtain a regular primary care provider or a medical home.
(B) Provide case management and care
management.
(C) Perform health outreach using neighborhood health workers or through other
means.
(D) Provide transportation.
(E) Expand capacity, including through
telehealth, after-hours services or urgent
care.
(F) Provide direct patient care services.
(2) Grant funds to HRSA grantees
The Secretary may limit the percent of
grant funding that may be spent on direct care
services provided by grantees of programs administered by the Health Resources and Services Administration or impose other requirements on such grantees deemed necessary.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2011 through 2015.
(July 1, 1944, ch. 373, title III, § 340H, as added
Pub. L. 111–148, title X, § 10333, Mar. 23, 2010, 124
Stat. 970.)
CODIFICATION
Another section 340H of act July 1, 1944, ch. 373, as
added by Pub. L. 111–148, title V, § 5508(c), March 23,
2010, 124 Stat. 670, is classified to section 256h of this
title.

PART E—NARCOTIC ADDICTS AND OTHER DRUG
ABUSERS
§ 257. Repealed. Pub. L. 106–310, div. B, title
XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221
Section, acts July 1, 1944, ch. 373, title III, § 341, 58
Stat. 698; May 8, 1954, ch. 195, § 3, 68 Stat. 80; July 24,
1956, ch. 676, title III, § 302(a), 70 Stat. 622; Pub. L. 89–793,
title VI, § 601, Nov. 8, 1966, 80 Stat. 1449; 1967 Reorg. Plan
No. 3, § 401, eff. Nov. 3, 1967 (in part), 32 F.R. 11669, 81
Stat. 951; Pub. L. 91–513, title I, § 2(a)(1), Oct. 27, 1970, 84
Stat. 1240; Pub. L. 92–255, title IV, § 402, Mar. 21, 1972, 86
Stat. 77; Pub. L. 93–198, title IV, § 421, Dec. 24, 1973, 87
Stat. 789; Pub. L. 98–473, title II, § 232(a), Oct. 12, 1984, 98
Stat. 2031; Pub. L. 99–646, § 22(a), Nov. 10, 1986, 100 Stat.
3597; Pub. L. 102–54, § 13(q)(1)(B)(i), June 13, 1991, 105
Stat. 278, related to care and treatment of narcotic addicts.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 257a. Transferred
CODIFICATION
Section, Pub. L. 91–513, title I, § 4, Oct. 27, 1970, 84
Stat. 1241; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695, which related to medical treatment of narcotics addiction, was transferred to section 290bb–2a of
this title.

§ 258. Repealed. Pub. L. 106–310, div. B, title
XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221
Section, acts July 1, 1944, ch. 373, title III, § 342, 58
Stat. 699; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631; Pub. L. 91–513, title I,
§ 2(a)(2)(A), Oct. 27, 1970, 84 Stat. 1240; Pub. L. 96–88,
title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, related to employment, establishment of industries, plants, etc., sale
of commodities, and disposition of proceeds.

§ 258a. Transferred
CODIFICATION
Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat.
269, which related to transfer of balances in working
capital fund, narcotic hospitals, to surplus fund, was
transferred and is set out as a note under section 290aa
of this title.

§§ 259 to 261a. Repealed. Pub. L. 106–310, div. B,
title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat.
1221
Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58
Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct.
27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86
Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98
Stat. 2031, related to convict addicts or other persons
with drug abuse or drug dependence problems.
Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58
Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24,
1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513,
title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, related to addicts and persons with drug abuse or drug
dependence problems.
Section 260a, act July 1, 1944, ch. 373, title III, § 345, as
added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July
24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L.
91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, related to admission of addicts committed from District
of Columbia.
Section 261, acts July 1, 1944, ch. 373, title III, § 346,
formerly § 345, 58 Stat. 701; renumbered § 346, May 8,
1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513,
title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, related
to penalties for introducing prohibited articles and substances into hospitals and escaping from, or aiding and
abetting escape from hospitals.
Section 261a, act July 1, 1944, ch. 373, title III, § 347, as
added May 8, 1954, ch. 195, § 4, 68 Stat. 80; amended Pub.
L. 91–513, title I, § 2(a)(4), Oct. 27, 1970, 84 Stat. 1240, related to release of patients and determination by Surgeon General.

PART F—LICENSING OF BIOLOGICAL PRODUCTS
AND CLINICAL LABORATORIES
SUBPART 1—BIOLOGICAL PRODUCTS

§ 262. Regulation of biological products
(a) Biologics license
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection
or subsection (k) is in effect for the biological
product; and

§ 262

(B) each package of the biological product is
plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological
product.
(2)(A) The Secretary shall establish, by regulation, requirements for the approval, suspension,
and revocation of biologics licenses.
(B) PEDIATRIC STUDIES.—A person that submits
an application for a license under this paragraph
shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological
product is manufactured, processed, packed,
or held meets standards designed to assure
that the biological product continues to be
safe, pure, and potent; and
(ii) if the applicant (or other appropriate
person) consents to the inspection of the facility that is the subject of the application, in
accordance with subsection (c) of this section.
(D) POSTMARKET STUDIES AND CLINICAL TRIALS;
LABELING; RISK EVALUATION AND MITIGATION
STRATEGY.—A person that submits an application for a license under this paragraph is subject
to sections 505(o), 505(p), and 505–1 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 355(o),
(p), 355–1].
(3) The Secretary shall prescribe requirements
under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1).
(b) Falsely labeling or marking package or container; altering label or mark
No person shall falsely label or mark any
package or container of any biological product
or alter any label or mark on the package or
container of the biological product so as to falsify the label or mark.
(c) Inspection of establishment for propagation
and preparation
Any officer, agent, or employee of the Department of Health and Human Services, authorized
by the Secretary for the purpose, may during all
reasonable hours enter and inspect any establishment for the propagation or manufacture
and preparation of any biological product.
(d) Recall of product presenting imminent hazard; violations
(1) Upon a determination that a batch, lot, or
other quantity of a product licensed under this
section presents an imminent or substantial
hazard to the public health, the Secretary shall
issue an order immediately ordering the recall
of such batch, lot, or other quantity of such
product. An order under this paragraph shall be
issued in accordance with section 554 of title 5.

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(2) Any violation of paragraph (1) shall subject
the violator to a civil penalty of up to $100,000
per day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year beginning 1 year after the
effective date of this paragraph, be increased by
the percent change in the Consumer Price Index
for the base quarter of such year over the Consumer Price Index for the base quarter of the
preceding year, adjusted to the nearest 1⁄10 of 1
percent. For purposes of this paragraph, the
term ‘‘base quarter’’, as used with respect to a
year, means the calendar quarter ending on September 30 of such year and the price index for a
base quarter is the arithmetical mean of such
index for the 3 months comprising such quarter.
(e) Interference with officers
No person shall interfere with any officer,
agent, or employee of the Service in the performance of any duty imposed upon him by this
section or by regulations made by authority
thereof.
(f) Penalties for offenses
Any person who shall violate, or aid or abet in
violating, any of the provisions of this section
shall be punished upon conviction by a fine not
exceeding $500 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.
(g) Construction with other laws
Nothing contained in this chapter shall be
construed as in any way affecting, modifying,
repealing, or superseding the provisions of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.].
(h) Exportation of partially processed biological
products
A partially processed biological product
which—
(1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries
of man;
(2) is not intended for sale in the United
States; and
(3) is intended for further manufacture into
final dosage form outside the United States,
shall be subject to no restriction on the export
of the product under this chapter or the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et.
seq.] if the product is manufactured, processed,
packaged, and held in conformity with current
good manufacturing practice requirements or
meets international manufacturing standards as
certified by an international standards organization recognized by the Secretary and meets the
requirements of section 801(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).
(i) ‘‘Biological product’’ defined
In this section:
(1) The term ‘‘biological product’’ means a
virus, therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or derivative,
allergenic product, protein (except any chemically synthesized polypeptide), or analogous
product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention,

Page 356

treatment, or cure of a disease or condition of
human beings.
(2) The term ‘‘biosimilar’’ or ‘‘biosimilarity’’, in reference to a biological product that
is the subject of an application under subsection (k), means—
(A) that the biological product is highly
similar to the reference product notwithstanding minor differences in clinically inactive components; and
(B) there are no clinically meaningful differences between the biological product and
the reference product in terms of the safety,
purity, and potency of the product.
(3) The term ‘‘interchangeable’’ or ‘‘interchangeability’’, in reference to a biological
product that is shown to meet the standards
described in subsection (k)(4), means that the
biological product may be substituted for the
reference product without the intervention of
the health care provider who prescribed the
reference product.
(4) The term ‘‘reference product’’ means the
single biological product licensed under subsection (a) against which a biological product
is evaluated in an application submitted under
subsection (k).
(j) Application of Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.], including the requirements
under sections 505(o), 505(p), and 505–1 of such
Act [21 U.S.C. 355(o), (p), 355–1], applies to a biological product subject to regulation under this
section, except that a product for which a license has been approved under subsection (a)
shall not be required to have an approved application under section 505 of such Act.
(k) Licensure of biological products as biosimilar
or interchangeable
(1) In general
Any person may submit an application for
licensure of a biological product under this
subsection.
(2) Content
(A) In general
(i) Required information
An application submitted under this subsection shall include information demonstrating that—
(I) the biological product is biosimilar
to a reference product based upon data
derived from—
(aa) analytical studies that demonstrate that the biological product is
highly similar to the reference product
notwithstanding minor differences in
clinically inactive components;
(bb) animal studies (including the assessment of toxicity); and
(cc) a clinical study or studies (including
the
assessment
of
immunogenicity and pharmacokinetics
or pharmacodynamics) that are sufficient to demonstrate safety, purity,
and potency in 1 or more appropriate
conditions of use for which the reference product is licensed and intended

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
to be used and for which licensure is
sought for the biological product;

(II) the biological product and reference product utilize the same mechanism or mechanisms of action for the
condition or conditions of use prescribed,
recommended, or suggested in the proposed labeling, but only to the extent
the mechanism or mechanisms of action
are known for the reference product;
(III) the condition or conditions of use
prescribed, recommended, or suggested
in the labeling proposed for the biological product have been previously approved for the reference product;
(IV) the route of administration, the
dosage form, and the strength of the biological product are the same as those of
the reference product; and
(V) the facility in which the biological
product is manufactured, processed,
packed, or held meets standards designed
to assure that the biological product
continues to be safe, pure, and potent.
(ii) Determination by Secretary
The Secretary may determine, in the
Secretary’s discretion, that an element described in clause (i)(I) is unnecessary in an
application submitted under this subsection.
(iii) Additional information
An application submitted under this subsection—
(I) shall include publicly-available information regarding the Secretary’s previous determination that the reference
product is safe, pure, and potent; and
(II) may include any additional information in support of the application, including publicly-available information
with respect to the reference product or
another biological product.
(B) Interchangeability
An application (or a supplement to an application) submitted under this subsection
may include information demonstrating
that the biological product meets the standards described in paragraph (4).
(3) Evaluation by Secretary
Upon review of an application (or a supplement to an application) submitted under this
subsection, the Secretary shall license the biological product under this subsection if—
(A) the Secretary determines that the information submitted in the application (or
the supplement) is sufficient to show that
the biological product—
(i) is biosimilar to the reference product;
or
(ii) meets the standards described in
paragraph (4), and therefore is interchangeable with the reference product; and
(B) the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in
accordance with subsection (c).

§ 262

(4) Safety standards for determining interchangeability
Upon review of an application submitted
under this subsection or any supplement to
such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to
such application) is sufficient to show that—
(A) the biological product—
(i) is biosimilar to the reference product;
and
(ii) can be expected to produce the same
clinical result as the reference product in
any given patient; and
(B) for a biological product that is administered more than once to an individual, the
risk in terms of safety or diminished efficacy of alternating or switching between use
of the biological product and the reference
product is not greater than the risk of using
the reference product without such alternation or switch.
(5) General rules
(A) One reference product per application
A biological product, in an application
submitted under this subsection, may not be
evaluated against more than 1 reference
product.
(B) Review
An application submitted under this subsection shall be reviewed by the division
within the Food and Drug Administration
that is responsible for the review and approval of the application under which the
reference product is licensed.
(C) Risk evaluation and mitigation strategies
The authority of the Secretary with respect to risk evaluation and mitigation
strategies under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] shall
apply to biological products licensed under
this subsection in the same manner as such
authority applies to biological products licensed under subsection (a).
(6) Exclusivity for first interchangeable biological product
Upon review of an application submitted
under this subsection relying on the same reference product for which a prior biological
product has received a determination of interchangeability for any condition of use, the
Secretary shall not make a determination
under paragraph (4) that the second or subsequent biological product is interchangeable for
any condition of use until the earlier of—
(A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as
interchangeable for that reference product;
(B) 18 months after—
(i) a final court decision on all patents in
suit in an action instituted under subsection (l)(6) against the applicant that
submitted the application for the first approved interchangeable biosimilar biological product; or

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that
submitted the application for the first approved interchangeable biosimilar biological product; or

(C)(i) 42 months after approval of the first
interchangeable biosimilar biological product if the applicant that submitted such application has been sued under subsection
(l)(6) and such litigation is still ongoing
within such 42-month period; or
(ii) 18 months after approval of the first
interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection
(l)(6).
For purposes of this paragraph, the term
‘‘final court decision’’ means a final decision
of a court from which no appeal (other than a
petition to the United States Supreme Court
for a writ of certiorari) has been or can be
taken.
(7) Exclusivity for reference product
(A) Effective date of biosimilar application
approval
Approval of an application under this subsection may not be made effective by the
Secretary until the date that is 12 years
after the date on which the reference product was first licensed under subsection (a).
(B) Filing period
An application under this subsection may
not be submitted to the Secretary until the
date that is 4 years after the date on which
the reference product was first licensed
under subsection (a).
(C) First licensure
Subparagraphs (A) and (B) shall not apply
to a license for or approval of—
(i) a supplement for the biological product that is the reference product; or
(ii) a subsequent application filed by the
same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest,
or other related entity) for—
(I) a change (not including a modification to the structure of the biological
product) that results in a new indication,
route of administration, dosing schedule,
dosage form, delivery system, delivery
device, or strength; or
(II) a modification to the structure of
the biological product that does not result in a change in safety, purity, or potency.
(8) Guidance documents
(A) In general
The Secretary may, after opportunity for
public comment, issue guidance in accordance, except as provided in subparagraph
(B)(i), with section 701(h) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.
371(h)] with respect to the licensure of a biological product under this subsection. Any
such guidance may be general or specific.

Page 358

(B) Public comment
(i) In general
The Secretary shall provide the public
an opportunity to comment on any proposed guidance issued under subparagraph
(A) before issuing final guidance.
(ii) Input regarding most valuable guidance
The Secretary shall establish a process
through which the public may provide the
Secretary with input regarding priorities
for issuing guidance.
(C) No requirement for application consideration
The issuance (or non-issuance) of guidance
under subparagraph (A) shall not preclude
the review of, or action on, an application
submitted under this subsection.
(D) Requirement for product class-specific
guidance
If the Secretary issues product class-specific guidance under subparagraph (A), such
guidance shall include a description of—
(i) the criteria that the Secretary will
use to determine whether a biological
product is highly similar to a reference
product in such product class; and
(ii) the criteria, if available, that the
Secretary will use to determine whether a
biological product meets the standards described in paragraph (4).
(E) Certain product classes
(i) Guidance
The Secretary may indicate in a guidance document that the science and experience, as of the date of such guidance,
with respect to a product or product class
(not including any recombinant protein)
does not allow approval of an application
for a license as provided under this subsection for such product or product class.
(ii) Modification or reversal
The Secretary may issue a subsequent
guidance document under subparagraph
(A) to modify or reverse a guidance document under clause (i).
(iii) No effect on ability to deny license
Clause (i) shall not be construed to require the Secretary to approve a product
with respect to which the Secretary has
not indicated in a guidance document that
the science and experience, as described in
clause (i), does not allow approval of such
an application.
(l) Patents
(1) Confidential access to subsection (k) application
(A) Application of paragraph
Unless otherwise agreed to by a person
that submits an application under subsection (k) (referred to in this subsection as
the ‘‘subsection (k) applicant’’) and the
sponsor of the application for the reference
product (referred to in this subsection as the
‘‘reference product sponsor’’), the provisions

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of this paragraph shall apply to the exchange of information described in this subsection.
(B) In general
(i) Provision of confidential information
When a subsection (k) applicant submits
an application under subsection (k), such
applicant shall provide to the persons described in clause (ii), subject to the terms
of this paragraph, confidential access to
the information required to be produced
pursuant to paragraph (2) and any other
information that the subsection (k) applicant determines, in its sole discretion, to
be appropriate (referred to in this subsection as the ‘‘confidential information’’).
(ii) Recipients of information
The persons described in this clause are
the following:
(I) Outside counsel
One or more attorneys designated by
the reference product sponsor who are
employees of an entity other than the
reference product sponsor (referred to in
this paragraph as the ‘‘outside counsel’’),
provided that such attorneys do not engage, formally or informally, in patent
prosecution relevant or related to the
reference product.
(II) In-house counsel
One attorney that represents the reference product sponsor who is an employee of the reference product sponsor,
provided that such attorney does not engage, formally or informally, in patent
prosecution relevant or related to the
reference product.
(iii) Patent owner access
A representative of the owner of a patent
exclusively licensed to a reference product
sponsor with respect to the reference product and who has retained a right to assert
the patent or participate in litigation concerning the patent may be provided the
confidential information, provided that
the representative informs the reference
product sponsor and the subsection (k) applicant of his or her agreement to be subject to the confidentiality provisions set
forth in this paragraph, including those
under clause (ii).
(C) Limitation on disclosure
No person that receives confidential information pursuant to subparagraph (B) shall
disclose any confidential information to any
other person or entity, including the reference product sponsor employees, outside
scientific consultants, or other outside counsel retained by the reference product sponsor, without the prior written consent of the
subsection (k) applicant, which shall not be
unreasonably withheld.
(D) Use of confidential information
Confidential information shall be used for
the sole and exclusive purpose of determining, with respect to each patent assigned to

§ 262

or exclusively licensed by the reference
product sponsor, whether a claim of patent
infringement could reasonably be asserted if
the subsection (k) applicant engaged in the
manufacture, use, offering for sale, sale, or
importation into the United States of the biological product that is the subject of the
application under subsection (k).
(E) Ownership of confidential information
The confidential information disclosed
under this paragraph is, and shall remain,
the property of the subsection (k) applicant.
By providing the confidential information
pursuant to this paragraph, the subsection
(k) applicant does not provide the reference
product sponsor or the outside counsel any
interest in or license to use the confidential
information, for purposes other than those
specified in subparagraph (D).
(F) Effect of infringement action
In the event that the reference product
sponsor files a patent infringement suit, the
use of confidential information shall continue to be governed by the terms of this
paragraph until such time as a court enters
a protective order regarding the information. Upon entry of such order, the subsection (k) applicant may redesignate confidential information in accordance with the
terms of that order. No confidential information shall be included in any publiclyavailable complaint or other pleading. In the
event that the reference product sponsor
does not file an infringement action by the
date specified in paragraph (6), the reference
product sponsor shall return or destroy all
confidential information received under this
paragraph, provided that if the reference
product sponsor opts to destroy such information, it will confirm destruction in writing to the subsection (k) applicant.
(G) Rule of construction
Nothing in this paragraph shall be construed—
(i) as an admission by the subsection (k)
applicant regarding the validity, enforceability, or infringement of any patent; or
(ii) as an agreement or admission by the
subsection (k) applicant with respect to
the competency, relevance, or materiality
of any confidential information.
(H) Effect of violation
The disclosure of any confidential information in violation of this paragraph shall
be deemed to cause the subsection (k) applicant to suffer irreparable harm for which
there is no adequate legal remedy and the
court shall consider immediate injunctive
relief to be an appropriate and necessary
remedy for any violation or threatened violation of this paragraph.
(2) Subsection (k) application information
Not later than 20 days after the Secretary
notifies the subsection (k) applicant that the
application has been accepted for review, the
subsection (k) applicant—
(A) shall provide to the reference product
sponsor a copy of the application submitted

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

to the Secretary under subsection (k), and
such other information that describes the
process or processes used to manufacture the
biological product that is the subject of such
application; and
(B) may provide to the reference product
sponsor additional information requested by
or on behalf of the reference product sponsor.
(3) List and description of patents
(A) List by reference product sponsor
Not later than 60 days after the receipt of
the application and information under paragraph (2), the reference product sponsor
shall provide to the subsection (k) applicant—
(i) a list of patents for which the reference product sponsor believes a claim of
patent infringement could reasonably be
asserted by the reference product sponsor,
or by a patent owner that has granted an
exclusive license to the reference product
sponsor with respect to the reference product, if a person not licensed by the reference product sponsor engaged in the
making, using, offering to sell, selling, or
importing into the United States of the biological product that is the subject of the
subsection (k) application; and
(ii) an identification of the patents on
such list that the reference product sponsor would be prepared to license to the
subsection (k) applicant.
(B) List and description by subsection (k) applicant
Not later than 60 days after receipt of the
list under subparagraph (A), the subsection
(k) applicant—
(i) may provide to the reference product
sponsor a list of patents to which the subsection (k) applicant believes a claim of
patent infringement could reasonably be
asserted by the reference product sponsor
if a person not licensed by the reference
product sponsor engaged in the making,
using, offering to sell, selling, or importing into the United States of the biological
product that is the subject of the subsection (k) application;
(ii) shall provide to the reference product
sponsor, with respect to each patent listed
by the reference product sponsor under
subparagraph (A) or listed by the subsection (k) applicant under clause (i)—
(I) a detailed statement that describes,
on a claim by claim basis, the factual
and legal basis of the opinion of the subsection (k) applicant that such patent is
invalid, unenforceable, or will not be infringed by the commercial marketing of
the biological product that is the subject
of the subsection (k) application; or
(II) a statement that the subsection (k)
applicant does not intend to begin commercial marketing of the biological
product before the date that such patent
expires; and
(iii) shall provide to the reference product sponsor a response regarding each pat-

Page 360

ent identified by the reference product
sponsor under subparagraph (A)(ii).
(C) Description by reference product sponsor
Not later than 60 days after receipt of the
list and statement under subparagraph (B),
the reference product sponsor shall provide
to the subsection (k) applicant a detailed
statement that describes, with respect to
each patent described in subparagraph
(B)(ii)(I), on a claim by claim basis, the factual and legal basis of the opinion of the reference product sponsor that such patent will
be infringed by the commercial marketing of
the biological product that is the subject of
the subsection (k) application and a response
to the statement concerning validity and enforceability provided under subparagraph
(B)(ii)(I).
(4) Patent resolution negotiations
(A) In general
After receipt by the subsection (k) applicant of the statement under paragraph
(3)(C), the reference product sponsor and the
subsection (k) applicant shall engage in good
faith negotiations to agree on which, if any,
patents listed under paragraph (3) by the
subsection (k) applicant or the reference
product sponsor shall be the subject of an action for patent infringement under paragraph (6).
(B) Failure to reach agreement
If, within 15 days of beginning negotiations
under subparagraph (A), the subsection (k)
applicant and the reference product sponsor
fail to agree on a final and complete list of
which, if any, patents listed under paragraph
(3) by the subsection (k) applicant or the reference product sponsor shall be the subject
of an action for patent infringement under
paragraph (6), the provisions of paragraph (5)
shall apply to the parties.
(5) Patent resolution if no agreement
(A) Number of patents
The subsection (k) applicant shall notify
the reference product sponsor of the number
of patents that such applicant will provide
to the reference product sponsor under subparagraph (B)(i)(I).
(B) Exchange of patent lists
(i) In general
On a date agreed to by the subsection (k)
applicant and the reference product sponsor, but in no case later than 5 days after
the subsection (k) applicant notifies the
reference product sponsor under subparagraph (A), the subsection (k) applicant and
the reference product sponsor shall simultaneously exchange—
(I) the list of patents that the subsection (k) applicant believes should be
the subject of an action for patent infringement under paragraph (6); and
(II) the list of patents, in accordance
with clause (ii), that the reference product sponsor believes should be the subject of an action for patent infringement
under paragraph (6).

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(ii) Number of patents listed by reference
product sponsor
(I) In general
Subject to subclause (II), the number
of patents listed by the reference product sponsor under clause (i)(II) may not
exceed the number of patents listed by
the subsection (k) applicant under clause
(i)(I).
(II) Exception
If a subsection (k) applicant does not
list any patent under clause (i)(I), the
reference product sponsor may list 1 patent under clause (i)(II).
(6) Immediate patent infringement action
(A) Action if agreement on patent list
If the subsection (k) applicant and the reference product sponsor agree on patents as
described in paragraph (4), not later than 30
days after such agreement, the reference
product sponsor shall bring an action for
patent infringement with respect to each
such patent.
(B) Action if no agreement on patent list
If the provisions of paragraph (5) apply to
the parties as described in paragraph (4)(B),
not later than 30 days after the exchange of
lists under paragraph (5)(B), the reference
product sponsor shall bring an action for
patent infringement with respect to each
patent that is included on such lists.
(C) Notification and publication of complaint
(i) Notification to Secretary
Not later than 30 days after a complaint
is served to a subsection (k) applicant in
an action for patent infringement described under this paragraph, the subsection (k) applicant shall provide the Secretary with notice and a copy of such complaint.
(ii) Publication by Secretary
The Secretary shall publish in the Federal Register notice of a complaint received under clause (i).
(7) Newly issued or licensed patents
In the case of a patent that—
(A) is issued to, or exclusively licensed by,
the reference product sponsor after the date
that the reference product sponsor provided
the list to the subsection (k) applicant under
paragraph (3)(A); and
(B) the reference product sponsor reasonably believes that, due to the issuance of
such patent, a claim of patent infringement
could reasonably be asserted by the reference product sponsor if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell,
selling, or importing into the United States
of the biological product that is the subject
of the subsection (k) application,
not later than 30 days after such issuance or
licensing, the reference product sponsor shall
provide to the subsection (k) applicant a supplement to the list provided by the reference

§ 262

product sponsor under paragraph (3)(A) that
includes such patent, not later than 30 days
after such supplement is provided, the subsection (k) applicant shall provide a statement
to the reference product sponsor in accordance
with paragraph (3)(B), and such patent shall be
subject to paragraph (8).
(8) Notice of commercial marketing and preliminary injunction
(A) Notice of commercial marketing
The subsection (k) applicant shall provide
notice to the reference product sponsor not
later than 180 days before the date of the
first commercial marketing of the biological
product licensed under subsection (k).
(B) Preliminary injunction
After receiving the notice under subparagraph (A) and before such date of the first
commercial marketing of such biological
product, the reference product sponsor may
seek a preliminary injunction prohibiting
the subsection (k) applicant from engaging
in the commercial manufacture or sale of
such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any
patent that is—
(i) included in the list provided by the
reference product sponsor under paragraph
(3)(A) or in the list provided by the subsection (k) applicant under paragraph
(3)(B); and
(ii) not included, as applicable, on—
(I) the list of patents described in paragraph (4); or
(II) the lists of patents described in
paragraph (5)(B).
(C) Reasonable cooperation
If the reference product sponsor has sought
a preliminary injunction under subparagraph (B), the reference product sponsor and
the subsection (k) applicant shall reasonably
cooperate to expedite such further discovery
as is needed in connection with the preliminary injunction motion.
(9) Limitation on declaratory judgment action
(A) Subsection (k) application provided
If a subsection (k) applicant provides the
application and information required under
paragraph (2)(A), neither the reference product sponsor nor the subsection (k) applicant
may, prior to the date notice is received
under paragraph (8)(A), bring any action
under section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that is described in
clauses (i) and (ii) of paragraph (8)(B).
(B) Subsequent failure to act by subsection
(k) applicant
If a subsection (k) applicant fails to complete an action required of the subsection (k)
applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7),
or paragraph (8)(A), the reference product
sponsor, but not the subsection (k) applicant, may bring an action under section 2201
of title 28 for a declaration of infringement,

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validity, or enforceability of any patent included in the list described in paragraph
(3)(A), including as provided under paragraph (7).
(C) Subsection (k) application not provided
If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k)
applicant, may bring an action under section
2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a
use of the biological product.
(m) Pediatric studies
(1) Application of certain provisions
The provisions of subsections (a), (d), (e), (f),
(i), (j), (k), (l), (p), and (q) of section 505A of
the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355a(a), (d), (e), (f), (i), (j), (k), (l), (p),
(q)] shall apply with respect to the extension
of a period under paragraphs (2) and (3) to the
same extent and in the same manner as such
provisions apply with respect to the extension
of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(b), (c)].
(2) Market exclusivity for new biological products
If, prior to approval of an application that is
submitted under subsection (a), the Secretary
determines that information relating to the
use of a new biological product in the pediatric population may produce health benefits
in that population, the Secretary makes a
written request for pediatric studies (which
shall include a timeframe for completing such
studies), the applicant agrees to the request,
such studies are completed using appropriate
formulations for each age group for which the
study is requested within any such timeframe,
and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of
the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355a(d)(3)]—
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years
and 12 years and 6 months rather than 12
years; and
(B) if the biological product is designated
under section 526 1 [21 U.S.C. 360bb] for a rare
disease or condition, the period for such biological product referred to in section 527(a) 1
[21 U.S.C. 360cc(a)] is deemed to be 7 years
and 6 months rather than 7 years.
(3) Market exclusivity for already-marketed biological products
If the Secretary determines that information relating to the use of a licensed biological
product in the pediatric population may
produce health benefits in that population and
makes a written request to the holder of an
approved application under subsection (a) for
pediatric studies (which shall include a timeframe for completing such studies), the holder
1 See

References in Text note below.

Page 362

agrees to the request, such studies are completed using appropriate formulations for each
age group for which the study is requested
within any such timeframe, and the reports
thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.
355a(d)(3)]—
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years
and 12 years and 6 months rather than 12
years; and
(B) if the biological product is designated
under section 526 1 [21 U.S.C. 360bb] for a rare
disease or condition, the period for such biological product referred to in section 527(a) 1
[21 U.S.C. 360cc(a)] is deemed to be 7 years
and 6 months rather than 7 years.
(4) Exception
The Secretary shall not extend a period referred to in paragraph (2)(A), (2)(B), (3)(A), or
(3)(B) if the determination under section
505A(d)(3) 1 [21 U.S.C. 355a(d)(3)] is made later
than 9 months prior to the expiration of such
period.
(July 1, 1944, ch. 373, title III, § 351, 58 Stat. 702;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 85–881, § 2, Sept. 2,
1958, 72 Stat. 1704; Pub. L. 91–515, title II, § 291,
Oct. 30, 1970, 84 Stat. 1308; Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 99–660,
title I, § 105(a), title III, § 315, Nov. 14, 1986, 100
Stat. 3751, 3783; Pub. L. 102–300, § 6(b)(1), June 16,
1992, 106 Stat. 240; Pub. L. 104–134, title II,
§§ 2102(d)(2), 2104, Apr. 26, 1996, 110 Stat. 1321–319,
1321–320; Pub. L. 105–115, title I, § 123(a)–(d), (g),
Nov. 21, 1997, 111 Stat. 2323, 2324; Pub. L. 108–155,
§ 2(b)(3), Dec. 3, 2003, 117 Stat. 1941; Pub. L.
110–85, title IX, § 901(c), Sept. 27, 2007, 121 Stat.
939; Pub. L. 111–148, title VII, § 7002(a), (b), (g)(1),
Mar. 23, 2010, 124 Stat. 804, 814, 819.)
REFERENCES IN TEXT
The effective date of this paragraph, referred to in
subsec. (d)(2), is the effective date of section 315 of Pub.
L. 99–660 which added subsec. (d)(2). See Effective Date
of 1986 Amendment note set out below.
The Federal Food, Drug, and Cosmetic Act, referred
to in subsecs. (g), (h), (j), and (k)(5)(C), is act June 25,
1938, ch. 675, 52 Stat. 1040, which is classified generally
to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs.
For complete classification of this Act to the Code, see
section 301 of Title 21 and Tables.
Sections 526, 527(a), and 505A(d)(3), referred to in subsec. (m)(2)(B), (3)(B), (4), probably mean sections 526,
527(a), and 505A(d)(3) of the Federal Food, Drug, and
Cosmetic Act, act June 25, 1938, ch. 675, which are classified to sections 360bb, 360cc(a), and 355a(d)(3), respectively, of Title 21, Food and Drugs.
AMENDMENTS
2010—Subsec. (a)(1)(A). Pub. L. 111–148, § 7002(a)(1), inserted ‘‘under this subsection or subsection (k)’’ after
‘‘biologics license’’.
Subsec. (i). Pub. L. 111–148, § 7002(b), substituted ‘‘In
this section:’’ for ‘‘In this section,’’, designated remainder of existing provisions as par. (1), substituted ‘‘The
term’’ for ‘‘the term’’, inserted ‘‘protein (except any
chemically synthesized polypeptide),’’ after ‘‘allergenic
product,’’, and added pars. (2) to (4).
Subsecs. (k), (l). Pub. L. 111–148, § 7002(a)(2), added
subsecs. (k) and (l).

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Subsec. (m). Pub. L. 111–148, § 7002(g)(1), added subsec.
(m).
2007—Subsec. (a)(2)(D). Pub. L. 110–85, § 901(c)(1), added
subpar. (D).
Subsec. (j). Pub. L. 110–85, § 901(c)(2), inserted
‘‘, including the requirements under sections 505(o),
505(p), and 505–1 of such Act,’’ after ‘‘and Cosmetic
Act’’.
2003—Subsec. (a)(2)(B), (C). Pub. L. 108–155 added subpar. (B) and redesignated former subpar. (B) as (C).
1997—Subsec. (a). Pub. L. 105–115, § 123(a)(1), amended
subsec. (a) generally. Prior to amendment, subsec. (a)
related to intrastate and interstate traffic in biological
products and suspension or revocation of licenses as affecting prior sales.
Subsec. (b). Pub. L. 105–115, § 123(b), amended subsec.
(b) generally. Prior to amendment, subsec. (b) read as
follows: ‘‘No person shall falsely label or mark any
package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative,
allergenic product, or other product aforesaid; nor alter
any label or mark on any package or container of any
virus, serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, or other
product aforesaid so as to falsify such label or mark.’’
Subsec. (c). Pub. L. 105–115, § 123(c), substituted ‘‘biological product.’’ for ‘‘virus, serum, toxin, antitoxin,
vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid for sale, barter, or exchange in the District of Columbia, or to be
sent, carried, or brought from any State or possession
into any other State or possession or into any foreign
country, or from any foreign country into any State or
possession.’’
Subsec. (d). Pub. L. 105–115, § 123(a)(2), designated par.
(2) as subsec. (d), redesignated subpars. (A) and (B) of
par. (2) as pars. (1) and (2), respectively, in par. (2), substituted ‘‘Any violation of paragraph (1)’’ for ‘‘Any violation of subparagraph (A)’’ and substituted ‘‘this paragraph’’ for ‘‘this subparagraph’’ wherever appearing,
and struck out former par. (1) which read as follows:
‘‘Licenses for the maintenance of establishments for
the propagation or manufacture and preparation of
products described in subsection (a) of this section may
be issued only upon a showing that the establishment
and the products for which a license is desired meet
standards, designed to insure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued
only upon a showing that they meet such standards. All
such licenses shall be issued, suspended, and revoked as
prescribed by regulations and all licenses issued for the
maintenance of establishments for the propagation or
manufacture and preparation, in any foreign country,
of any such products for sale, barter, or exchange in
any State or possession shall be issued upon condition
that the licensees will permit the inspection of their
establishments in accordance with subsection (c) of
this section.’’
Subsec. (i). Pub. L. 105–115, § 123(d), added subsec. (i).
Subsec. (j). Pub. L. 105–115, § 123(g), added subsec. (j).
1996—Subsec. (h). Pub. L. 104–134, § 2104, amended subsec. (h) generally, revising and restating former provisions, which also related to exportation of partially
processed biological products.
Subsec. (h)(1)(A). Pub. L. 104–134, § 2102(d)(2), substituted ‘‘in a country listed under section 802(b)(1)’’ for
‘‘in a country listed under section 802(b)(A)’’ and ‘‘to a
country listed under section 802(b)(1)’’ for ‘‘to a country
listed under section 802(b)(4)’’.
1992—Subsec. (c). Pub. L. 102–300, which directed substitution of ‘‘Health and Human Services’’ for ‘‘Health,
Education, and Welfare’’, could not be executed because
the words ‘‘Health, Education, and Welfare’’ did not appear in original statutory text. Previously, references
to Department and Secretary of Health and Human
Services were substituted for references to Federal Security Agency and its Administrator pursuant to provisions cited in Transfer of Functions note below.
1986—Subsec. (d). Pub. L. 99–660, § 315, designated existing provisions as par. (1) and added par. (2).

§ 262

Subsec. (h). Pub. L. 99–660, § 105(a), added subsec. (h).
1970—Subsecs. (a) to (c). Pub. L. 91–515 inserted ‘‘vaccine, blood, blood component or derivative, allergenic
product,’’ after ‘‘antitoxin’’ wherever appearing.
1958—Subsec. (d). Pub. L. 85–881 struck out ‘‘made
jointly by the Surgeon General, the Surgeon General of
the Army, and the Surgeon General of the Navy, and
approved by the Secretary’’ after ‘‘regulations’’ in first
sentence.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 110–85 effective 180 days after
Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out
as a note under section 331 of Title 21, Food and Drugs.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–155 effective Dec. 3, 2003,
except as otherwise provided, see section 4 of Pub. L.
108–155, set out as an Effective Date note under section
355c of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105–115 effective 90 days after
Nov. 21, 1997, except as otherwise provided, see section
501 of Pub. L. 105–115, set out as a note under section 321
of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1986 AMENDMENT
Section 105(b) of Pub. L. 99–660 provided that: ‘‘Paragraph (1) of section 351(h) of the Public Health Service
Act [former subsec. (h)(1) of this section] as added by
subsection (a) shall take effect upon the expiration of
90 days after the date of the enactment of this Act
[Nov. 14, 1986].’’
Amendment by section 315 of Pub. L. 99–660 effective
Dec. 22, 1987, see section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section
300aa–1 of this title.
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
References to Secretary and Department of Health,
Education, and Welfare substituted for references to
Federal Security Administrator and Federal Security
Agency, respectively, pursuant to Reorg. Plan No. 1 of
1953, § 5, set out as a note under section 3501 of this
title, which transferred all functions of Federal Security Administrator to Secretary of Health, Education,
and Welfare and all agencies of Federal Security Agency to Department of Health, Education, and Welfare.
Federal Security Agency and office of Administrator
abolished by section 8 of Reorg. Plan No. 1 of 1953. Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health
and Human Services by section 509(b) of Pub. L. 96–88
which is classified to section 3508(b) of Title 20.
PRODUCTS PREVIOUSLY APPROVED UNDER THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT
Pub. L. 111–148, title VII, § 7002(e), Mar. 23, 2010, 124
Stat. 817, provided that:
‘‘(1) REQUIREMENT TO FOLLOW SECTION 351.—Except as
provided in paragraph (2), an application for a biological product shall be submitted under section 351 of the
Public Health Service Act (42 U.S.C. 262) (as amended
by this Act).
‘‘(2) EXCEPTION.—An application for a biological product may be submitted under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) if—

§ 262a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(A) such biological product is in a product class
for which a biological product in such product class
is the subject of an application approved under such
section 505 not later than the date of enactment of
this Act [Mar. 23, 2010]; and
‘‘(B) such application—
‘‘(i) has been submitted to the Secretary of
Health and Human Services (referred to in this subtitle [subtitle A (§§ 7001–7003) of title VII of Pub. L.
111–148, see Short Title of 2010 Amendment note
under section 201 of this title] as the ‘Secretary’)
before the date of enactment of this Act; or
‘‘(ii) is submitted to the Secretary not later than
the date that is 10 years after the date of enactment
of this Act.
‘‘(3) LIMITATION.—Notwithstanding paragraph (2), an
application for a biological product may not be submitted under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) if there is another biological product approved under subsection (a) of section 351
of the Public Health Service Act [42 U.S.C. 262] that
could be a reference product with respect to such application (within the meaning of such section 351) if such
application were submitted under subsection (k) of
such section 351.
‘‘(4) DEEMED APPROVED UNDER SECTION 351.—An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 on the date that
is 10 years after the date of enactment of this Act.
‘‘(5) DEFINITIONS.—For purposes of this subsection,
the term ‘biological product’ has the meaning given
such term under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).’’
COSTS OF REVIEWING BIOSIMILAR BIOLOGICAL PRODUCT
APPLICATIONS
Pub. L. 111–148, title VII, § 7002(f)(3)(B), (C), Mar. 23,
2010, 124 Stat. 818, 819, provided that:
‘‘(B) EVALUATION OF COSTS OF REVIEWING BIOSIMILAR
BIOLOGICAL PRODUCT APPLICATIONS.—During the period
beginning on the date of enactment of this Act [Mar.
23, 2010] and ending on October 1, 2010, the Secretary [of
Health and Human Services] shall collect and evaluate
data regarding the costs of reviewing applications for
biological products submitted under section 351(k) of
the Public Health Service Act [42 U.S.C. 262(k)] (as
added by this Act) during such period.
‘‘(C) AUDIT.—
‘‘(i) IN GENERAL.—On the date that is 2 years after
first receiving a user fee applicable to an application
for a biological product under section 351(k) of the
Public Health Service Act [42 U.S.C. 262(k)] (as added
by this Act), and on a biennial basis thereafter until
October 1, 2013, the Secretary shall perform an audit
of the costs of reviewing such applications under such
section 351(k). Such an audit shall compare—
‘‘(I) the costs of reviewing such applications
under such section 351(k) to the amount of the user
fee applicable to such applications; and
‘‘(II)(aa) such ratio determined under subclause
(I); to
‘‘(bb) the ratio of the costs of reviewing applications for biological products under section 351(a) of
such Act [42 U.S.C. 262(a)] (as amended by this Act)
to the amount of the user fee applicable to such applications under such section 351(a).
‘‘(ii) ALTERATION OF USER FEE.—If the audit performed under clause (i) indicates that the ratios compared under subclause (II) of such clause differ by
more than 5 percent, then the Secretary shall alter
the user fee applicable to applications submitted
under such section 351(k) [42 U.S.C. 262(k)] to more
appropriately account for the costs of reviewing such
applications.
‘‘(iii) ACCOUNTING STANDARDS.—The Secretary shall
perform an audit under clause (i) in conformance
with the accounting principles, standards, and requirements prescribed by the Comptroller General of

Page 364

the United States under section 3511 of title 31,
United State Code, to ensure the validity of any potential variability.’’
LICENSING OF ORPHAN PRODUCTS
Pub. L. 111–148, title VII, § 7002(h), Mar. 23, 2010, 124
Stat. 821, provided that: ‘‘If a reference product, as defined in section 351 of the Public Health Service Act (42
U.S.C. 262) (as amended by this Act) has been designated under section 526 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or
condition, a biological product seeking approval for
such disease or condition under subsection (k) of such
section 351 as biosimilar to, or interchangeable with,
such reference product may be licensed by the Secretary [of Health and Human Services] only after the
expiration for such reference product of the later of—
‘‘(1) the 7-year period described in section 527(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360cc(a)); and
‘‘(2) the 12-year period described in subsection (k)(7)
of such section 351.’’
SAVINGS GENERATED BY 2010 AMENDMENT
Pub. L. 111–148, title VII, § 7003, Mar. 23, 2010, 124 Stat.
821, provided that:
‘‘(a) DETERMINATION.—The Secretary of the Treasury,
in consultation with the Secretary of Health and
Human Services, shall for each fiscal year determine
the amount of savings to the Federal Government as a
result of the enactment of this subtitle [subtitle A
(§§ 7001–7003) of title VII of Pub. L. 111–148, see Short
Title of 2010 Amendment note under section 201 of this
title].
‘‘(b) USE.—Notwithstanding any other provision of
this subtitle (or an amendment made by this subtitle),
the savings to the Federal Government generated as a
result of the enactment of this subtitle shall be used
for deficit reduction.’’
ENHANCED PENALTIES AND CONTROL OF BIOLOGICAL
AGENTS
Pub. L. 104–132, title V, § 511, Apr. 24, 1996, 110 Stat.
1284, as amended by Pub. L. 107–188, title II, § 204, June
12, 2002, 116 Stat. 647, provided that:
‘‘(a) FINDINGS.—The Congress finds that—
‘‘(1) certain biological agents have the potential to
pose a severe threat to public health and safety;
‘‘(2) such biological agents can be used as weapons
by individuals or organizations for the purpose of domestic or international terrorism or for other criminal purposes;
‘‘(3) the transfer and possession of potentially hazardous biological agents should be regulated to protect public health and safety; and
‘‘(4) efforts to protect the public from exposure to
such agents should ensure that individuals and
groups with legitimate objectives continue to have
access to such agents for clinical and research purposes.
‘‘(b) CRIMINAL ENFORCEMENT.—[Amended sections 175,
177, and 178 of Title 18, Crimes and Criminal Procedure.]
‘‘(c) TERRORISM.—[Amended section 2332a of Title
18.]’’

§ 262a. Enhanced control of dangerous biological
agents and toxins
(a)

Regulatory control of certain biological
agents and toxins
(1) List of biological agents and toxins
(A) In general
The Secretary shall by regulation establish and maintain a list of each biological
agent and each toxin that has the potential
to pose a severe threat to public health and
safety.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Criteria
In determining whether to include an
agent or toxin on the list under subparagraph (A), the Secretary shall—
(i) consider—
(I) the effect on human health of exposure to the agent or toxin;
(II) the degree of contagiousness of the
agent or toxin and the methods by which
the agent or toxin is transferred to humans;
(III) the availability and effectiveness
of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or
toxin; and
(IV) any other criteria, including the
needs of children and other vulnerable
populations, that the Secretary considers appropriate; and
(ii) consult with appropriate Federal departments and agencies and with scientific
experts representing appropriate professional groups, including groups with pediatric expertise.
(2) Biennial review
The Secretary shall review and republish the
list under paragraph (1) biennially, or more
often as needed, and shall by regulation revise
the list as necessary in accordance with such
paragraph.
(b) Regulation of transfers of listed agents and
toxins
The Secretary shall by regulation provide
for—
(1) the establishment and enforcement of
safety procedures for the transfer of listed
agents and toxins, including measures to ensure—
(A) proper training and appropriate skills
to handle such agents and toxins; and
(B) proper laboratory facilities to contain
and dispose of such agents and toxins;
(2) the establishment and enforcement of
safeguard and security measures to prevent
access to such agents and toxins for use in domestic or international terrorism or for any
other criminal purpose;
(3) the establishment of procedures to protect the public safety in the event of a transfer or potential transfer of such an agent or
toxin in violation of the safety procedures established under paragraph (1) or the safeguard
and security measures established under paragraph (2); and
(4) appropriate availability of biological
agents and toxins for research, education, and
other legitimate purposes.
(c) Possession and use of listed agents and toxins
The Secretary shall by regulation provide for
the establishment and enforcement of standards
and procedures governing the possession and use
of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of
subsection (b) of this section, in order to protect
the public health and safety.

§ 262a

(d) Registration; identification; database
(1) Registration
Regulations under subsections (b) and (c) of
this section shall require registration with the
Secretary of the possession, use, and transfer
of listed agents and toxins, and shall include
provisions to ensure that persons seeking to
register under such regulations have a lawful
purpose to possess, use, or transfer such
agents and toxins, including provisions in accordance with subsection (e)(6) of this section.
(2) Identification; database
Regulations under subsections (b) and (c) of
this section shall require that registration include (if available to the person registering)
information regarding the characterization of
listed agents and toxins to facilitate their
identification, including their source. The Secretary shall maintain a national database that
includes the names and locations of registered
persons, the listed agents and toxins such persons are possessing, using, or transferring, and
information regarding the characterization of
such agents and toxins.
(e) Safeguard and security requirements for registered persons
(1) In general
Regulations under subsections (b) and (c) of
this section shall include appropriate safeguard and security requirements for persons
possessing, using, or transferring a listed
agent or toxin commensurate with the risk
such agent or toxin poses to public health and
safety (including the risk of use in domestic or
international terrorism). The Secretary shall
establish such requirements in collaboration
with the Secretary of Homeland Security and
the Attorney General, and shall ensure compliance with such requirements as part of the
registration system under such regulations.
(2) Limiting access to listed agents and toxins
Requirements under paragraph (1) shall include provisions to ensure that registered persons—
(A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents
and toxins;
(B) submit the names and other identifying information for such individuals to the
Secretary and the Attorney General,
promptly after first determining that the individuals need access under subparagraph
(A), and periodically thereafter while the individuals have such access, not less frequently than once every five years;
(C) deny access to such agents and toxins
by individuals whom the Attorney General
has identified as restricted persons; and
(D) limit or deny access to such agents and
toxins by individuals whom the Attorney
General has identified as within any category under paragraph (3)(B)(ii), if limiting
or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney
General.

§ 262a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Submitted names; use of databases by attorney general
(A) In general
Upon the receipt of names and other identifying information under paragraph (2)(B),
the Attorney General shall, for the sole purpose of identifying whether the individuals
involved are within any of the categories
specified in subparagraph (B), promptly use
criminal, immigration, national security,
and other electronic databases that are
available to the Federal Government and are
appropriate for such purpose.
(B) Certain individuals
For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—
(i) the individual is a restricted person;
or
(ii) the individual is reasonably suspected by any Federal law enforcement or
intelligence agency of—
(I) committing a crime set forth in section 2332b(g)(5) of title 18;
(II) knowing involvement with an organization that engages in domestic or
international terrorism (as defined in
section 2331 of such title 18) or with any
other organization that engages in intentional crimes of violence; or
(III) being an agent of a foreign power
(as defined in section 1801 of title 50).
(C) Notification by Attorney General regarding submitted names
After the receipt of a name and other identifying information under paragraph (2)(B),
the Attorney General shall promptly notify
the Secretary whether the individual is
within any of the categories specified in subparagraph (B).
(4) Notifications by Secretary
The Secretary, after receiving notice under
paragraph (3) regarding an individual, shall
promptly notify the registered person involved
of whether the individual is granted or denied
access under paragraph (2). If the individual is
denied such access, the Secretary shall
promptly notify the individual of the denial.
(5) Expedited review
Regulations under subsections (b) and (c) of
this section shall provide for a procedure
through which, upon request to the Secretary
by a registered person who submits names and
other identifying information under paragraph
(2)(B) and who demonstrates good cause, the
Secretary may, as determined appropriate by
the Secretary—
(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and
(B) expedite the notification of the registered person by the Secretary under paragraph (4).
(6) Process regarding persons seeking to register
(A) Individuals
Regulations under subsections (b) and (c)
of this section shall provide that an individ-

Page 366

ual who seeks to register under either of
such subsections is subject to the same processes described in paragraphs (2) through (4)
as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5)
does not apply for purposes of this subparagraph.
(B) Other persons
Regulations under subsections (b) and (c)
of this section shall provide that, in determining whether to deny or revoke registration by a person other than an individual,
the Secretary shall submit the name of such
person to the Attorney General, who shall
use criminal, immigration, national security, and other electronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying
the Secretary whether the person, or, where
relevant, the individual who owns or controls such person, is a restricted person or is
reasonably suspected by any Federal law enforcement or intelligence agency of being
within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including individuals). Such regulations shall provide
that a person who seeks to register under either of such subsections is subject to the
same processes described in paragraphs (2)
and (4) as apply to names and other identifying information submitted to the Attorney
General under paragraph (2)(B). Paragraph
(5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local governmental agencies
from the requirements of this subparagraph.
(7) Review
(A) Administrative review
(i) In general
Regulations under subsections (b) and (c)
of this section shall provide for an opportunity for a review by the Secretary—
(I) when requested by the individual
involved, of a determination under paragraph (2) to deny the individual access to
listed agents and toxins; and
(II) when requested by the person involved, of a determination under paragraph (6) to deny or revoke registration
for such person.
(ii) Ex parte review
During a review under clause (i), the
Secretary may consider information relevant to the review ex parte to the extent
that disclosure of the information could
compromise national security or an investigation by any law enforcement agency.
(iii) Final agency action
The decision of the Secretary in a review
under clause (i) constitutes final agency
action for purposes of section 702 of title 5.
(B) Certain procedures
(i) Submission of ex parte materials in judicial proceedings
When reviewing a decision of the Secretary under subparagraph (A), and upon

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request made ex parte and in writing by
the United States, a court, upon a sufficient showing, may review and consider ex
parte documents containing information
the disclosure of which could compromise
national security or an investigation by
any law enforcement agency. If the court
determines that portions of the documents
considered ex parte should be disclosed to
the person involved to allow a response,
the court shall authorize the United States
to delete from such documents specified
items of information the disclosure of
which could compromise national security
or an investigation by any law enforcement agency, or to substitute a summary
of the information to which the person
may respond. Any order by the court authorizing the disclosure of information
that the United States believes could compromise national security or an investigation by any law enforcement agency shall
be subject to the processes set forth in subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18 (relating to interlocutory appeal and expedited consideration).
(ii) Disclosure of information
In a review under subparagraph (A), and
in any judical 1 proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be
required to disclose to the public any information that under subsection (h) of this
section shall not be disclosed under section 552 of title 5.
(8) Notifications regarding theft or loss of
agents
Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and
local law enforcement agencies, of the theft or
loss of listed agents and toxins.
(9) Technical assistance for registered persons
The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security
of the facilities of such persons.
(f) Inspections
The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) of this section to ensure their
compliance with such regulations, including
prohibitions on restricted persons and other provisions of subsection (e) of this section.
(g) Exemptions
(1) Clinical or diagnostic laboratories
Regulations under subsections (b) and (c) of
this section shall exempt clinical or diagnostic
laboratories and other persons who possess,
use, or transfer listed agents or toxins that are
contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—
(A) the identification of such agents or
toxins is reported to the Secretary, and
1 So

in original. Probably should be ‘‘judicial’’.

§ 262a

when required under Federal, State, or local
law, to other appropriate authorities; and
(B) such agents or toxins are transferred or
destroyed in a manner set forth by the Secretary by regulation.
(2) Products
(A) In general
Regulations under subsections (b) and (c)
of this section shall exempt products that
are, bear, or contain listed agents or toxins
and are cleared, approved, licensed, or registered under any of the Acts specified in
subparagraph (B), unless the Secretary by
order determines that applying additional
regulation under subsection (b) or (c) of this
section to a specific product is necessary to
protect public health and safety.
(B) Relevant laws
For purposes of subparagraph (A), the Acts
specified in this subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(ii) Section 262 of this title.
(iii) The Act commonly known as the
Virus-Serum-Toxin Act (the eighth paragraph under the heading ‘‘Bureau of Animal Industry’’ in the Act of March 4, 1913;
21 U.S.C. 151–159).
(iv) The Federal Insecticide, Fungicide,
and Rodenticide Act [7 U.S.C. 136 et seq.].
(C) Investigational use
(i) In general
The Secretary may exempt an investigational product that is, bears, or contains a
listed agent or toxin from the applicability
of provisions of regulations under subsection (b) or (c) of this section when such
product is being used in an investigation
authorized under any Federal Act and the
Secretary determines that applying additional regulation under subsection (b) or
(c) of this section to such product is not
necessary to protect public health and
safety.
(ii) Certain processes
Regulations under subsections (b) and (c)
of this section shall set forth the procedures for applying for an exemption under
clause (i). In the case of investigational
products authorized under any of the Acts
specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption not later
than 14 days after the first date on which
both of the following conditions have been
met by the person requesting the exemption:
(I) The person has submitted to the
Secretary an application for the exemption meeting the requirements established by the Secretary.
(II) The person has notified the Secretary that the investigation has been
authorized under such an Act.
(3) Public health emergencies
The Secretary may temporarily exempt a
person from the applicability of the require-

§ 262a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ments of this section, in whole or in part, if
the Secretary determines that such exemption
is necessary to provide for the timely participation of the person in a response to a domestic or foreign public health emergency (whether determined under section 247d(a) of this
title or otherwise) that involves a listed agent
or toxin. With respect to the emergency involved, such exemption for a person may not
exceed 30 days, except that the Secretary,
after review of whether such exemption remains necessary, may provide one extension of
an additional 30 days.
(4) Agricultural emergencies
Upon request of the Secretary of Agriculture, after the granting by such Secretary
of an exemption under section 8401(g)(1)(D) of
title 7 pursuant to a finding that there is an
agricultural emergency, the Secretary of
Health and Human Services may temporarily
exempt a person from the applicability of the
requirements of this section, in whole or in
part, to provide for the timely participation of
the person in a response to the agricultural
emergency. With respect to the emergency involved, the exemption under this paragraph
for a person may not exceed 30 days, except
that upon request of the Secretary of Agriculture, the Secretary of Health and Human
Services may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.
(h) Disclosure of information
(1) Nondisclosure of certain information
No Federal agency specified in paragraph (2)
shall disclose under section 552 of title 5 any of
the following:
(A) Any registration or transfer documentation submitted under subsections (b)
and (c) of this section for the possession, use,
or transfer of a listed agent or toxin; or information derived therefrom to the extent
that it identifies the listed agent or toxin
possessed, used, or transferred by a specific
registered person or discloses the identity or
location of a specific registered person.
(B) The national database developed pursuant to subsection (d) of this section, or any
other compilation of the registration or
transfer information submitted under subsections (b) and (c) of this section to the extent that such compilation discloses sitespecific registration or transfer information.
(C) Any portion of a record that discloses
the site-specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to listed agents and toxins.
(D) Any notification of a release of a listed
agent or toxin submitted under subsections
(b) and (c) of this section, or any notification of theft or loss submitted under such
subsections.
(E) Any portion of an evaluation or report
of an inspection of a specific registered person conducted under subsection (f) of this
section that identifies the listed agent or
toxin possessed by a specific registered person or that discloses the identity or location

Page 368

of a specific registered person if the agency
determines that public disclosure of the information would endanger public health or
safety.
(2) Covered agencies
For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are
the following:
(A) The Department of Health and Human
Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.
(B) Any Federal agency to which information specified in paragraph (1) is transferred
by any agency specified in subparagraph (A)
of this paragraph.
(C) Any Federal agency that is a registered
person, or has a sub-agency component that
is a registered person.
(D) Any Federal agency that awards grants
or enters into contracts or cooperative
agreements involving listed agents and toxins to or with a registered person, and to
which information specified in paragraph (1)
is transferred by any such registered person.
(3) Other exemptions
This subsection may not be construed as altering the application of any exemptions to
public disclosure under section 552 of title 5,
except as to subsection 2 552(b)(3) of such title,
to any of the information specified in paragraph (1).
(4) Rule of construction
Except as specifically provided in paragraph
(1), this subsection may not be construed as altering the authority of any Federal agency to
withhold under section 552 of title 5, or the obligation of any Federal agency to disclose
under section 552 of title 5, any information,
including information relating to—
(A) listed agents and toxins, or individuals
seeking access to such agents and toxins;
(B) registered persons, or persons seeking
to register their possession, use, or transfer
of such agents and toxins;
(C) general safeguard and security policies
and requirements under regulations under
subsections (b) and (c) of this section; or
(D) summary or statistical information
concerning registrations, registrants, denials or revocations of registrations, listed
agents and toxins, inspection evaluations
and reports, or individuals seeking access to
such agents and toxins.
(5) Disclosures to Congress; other disclosures
This subsection may not be construed as
providing any authority—
(A) to withhold information from the Congress or any committee or subcommittee
thereof; or
(B) to withhold information from any person under any other Federal law or treaty.
(i) Civil money penalty
(1) In general
In addition to any other penalties that may
apply under law, any person who violates any
2 So

in original. Probably should be ‘‘section’’.

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provision of regulations under subsection (b)
or (c) of this section shall be subject to the
United States for a civil money penalty in an
amount not exceeding $250,000 in the case of an
individual and $500,000 in the case of any other
person.
(2) Applicability of certain provisions
The provisions of section 1320a–7a of this
title (other than subsections (a), (b), (h), and
(i), the first sentence of subsection (c), and
paragraphs (1) and (2) of subsection (f)) shall
apply to a civil money penalty under paragraph (1) in the same manner as such provisions apply to a penalty or proceeding under
section 1320a–7a(a) of this title. The Secretary
may delegate authority under this subsection
in the same manner as provided in section
1320a–7a(j)(2) of this title, and such authority
shall include all powers as contained in section 6 of the Inspector General Act of 1978 (5
U.S.C. App.).
(j) Notification in event of release
Regulations under subsections (b) and (c) of
this section shall require the prompt notification of the Secretary by a registered person
whenever a release, meeting criteria established
by the Secretary, of a listed agent or toxin has
occurred outside of the biocontainment area of a
facility of the registered person. Upon receipt of
such notification and a finding by the Secretary
that the release poses a threat to public health
or safety, the Secretary shall take appropriate
action to notify relevant State and local public
health authorities, other relevant Federal authorities, and, if necessary, other appropriate
persons (including the public). If the released
listed agent or toxin is an overlap agent or toxin
(as defined in subsection (l) of this section), the
Secretary shall promptly notify the Secretary of
Agriculture upon notification by the registered
person.
(k) Reports
The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) of this section (relating to theft or loss) and subsection (j)
of this section (relating to releases).
(l) Definitions
For purposes of this section:
(1) The terms ‘‘biological agent’’ and
‘‘toxin’’ have the meanings given such terms
in section 178 of title 18.
(2) The term ‘‘listed agents and toxins’’
means biological agents and toxins listed pursuant to subsection (a)(1) of this section.
(3) The term ‘‘listed agents or toxins’’ means
biological agents or toxins listed pursuant to
subsection (a)(1) of this section.
(4) The term ‘‘overlap agents and toxins’’
means biological agents and toxins that—
(A) are listed pursuant to subsection (a)(1)
of this section; and
(B) are listed pursuant to section 8401(a)(1)
of title 7.
(5) The term ‘‘overlap agent or toxin’’ means
a biological agent or toxin that—
(A) is listed pursuant to subsection (a)(1)
of this section; and

§ 262a

(B) is listed pursuant to section 8401(a)(1)
of title 7.
(6) The term ‘‘person’’ includes Federal,
State, and local governmental entities.
(7) The term ‘‘registered person’’ means a
person registered under regulations under subsection (b) or (c) of this section.
(8) The term ‘‘restricted person’’ has the
meaning given such term in section 175b of
title 18.
(m) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2002 through 2007.
(July 1, 1944, ch. 373, title III, § 351A, as added
Pub. L. 107–188, title II, § 201(a), June 12, 2002, 116
Stat. 637; amended Pub. L. 107–296, title XVII,
§ 1709(a), Nov. 25, 2002, 116 Stat. 2318.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec.(g)(2)(B)(i), is act June 25, 1938, ch. 675, 52
Stat. 1040, as amended, which is classified generally to
chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For
complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Act commonly known as the Virus-Serum-Toxin
Act, referred to in subsec. (g)(2)(B)(iii), is the eighth
paragraph under the heading ‘‘Bureau of Animal Industry’’ of act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is classified generally to chapter 5 (§ 151 et
seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note
set out under section 151 of Title 21 and Tables.
The Federal Insecticide, Fungicide, and Rodenticide
Act, referred to in subsec. (g)(2)(B)(iv), is act June 25,
1947, ch. 125, as amended generally by Pub. L. 92–516,
Oct. 21, 1972, 86 Stat. 973, which is classified generally
to subchapter II (§ 136 et seq.) of chapter 6 of Title 7,
Agriculture. For complete classification of this Act to
the Code, see Short Title note set out under section 136
of Title 7 and Tables.
Section 6 of the Inspector General Act of 1978, referred to in subsec. (i)(2), is section 6 of Pub. L. 95–452,
which is set out in the Appendix to Title 5, Government
Organization and Employees.
AMENDMENTS
2002—Subsec. (e)(1). Pub. L. 107–296 substituted ‘‘collaboration with the Secretary of Homeland Security
and’’ for ‘‘consultation with’’.
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107–296 effective 60 days after
Nov. 25, 2002, see section 4 of Pub. L. 107–296, set out as
an Effective Date note under section 101 of Title 6, Domestic Security.
EFFECTIVE DATE
Pub. L. 107–188, title II, § 203(b), June 12, 2002, 116 Stat.
647, provided that: ‘‘Subsection (h) of section 351A of
the Public Health Service Act [subsec. (h) of this section], as added by section 201 of this Act, is deemed to
have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub.
L. 104–132, Apr. 24, 1996, 110 Stat. 1214].’’
REGULATIONS
Pub. L. 107–188, title II, § 203(a), June 12, 2002, 116 Stat.
647, provided that: ‘‘Regulations promulgated by the
Secretary of Health and Human Services under section
511 of the Antiterrorism and Effective Death Penalty
Act of 1996 [Pub. L. 104–132, set out as a note under sec-

§ 262a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion 262 of this title] are deemed to have been promulgated under section 351A of the Public Health Service
Act [this section], as added by section 201 of this Act.
Such regulations, including the list under [former] subsection (d)(1) of such section 511, that were in effect on
the day before the date of the enactment of this Act
[June 12, 2002] remain in effect until modified by the
Secretary in accordance with such section 351A and
with section 202 of this Act [set out as a note below].’’
NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY
Pub. L. 109–417, title II, § 205, Dec. 19, 2006, 120 Stat.
2851, provided that: ‘‘The National Science Advisory
Board for Biosecurity shall, when requested by the Secretary of Health and Human Services, provide to relevant Federal departments and agencies, advice, guidance, or recommendations concerning—
‘‘(1) a core curriculum and training requirements
for workers in maximum containment biological laboratories; and
‘‘(2) periodic evaluations of maximum containment
biological laboratory capacity nationwide and assessments of the future need for increased laboratory capacity.’’
REPORT TO CONGRESS
Pub. L. 107–188, title II, § 201(b), June 12, 2002, 116 Stat.
646, required the Secretary of Health and Human Services to report to Congress not later than one year after
June 12, 2002, on the implementation, compliance, and
future plans under this section.
IMPLEMENTATION BY DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pub. L. 107–188, title II, § 202, June 12, 2002, 116 Stat.
646, provided that:
‘‘(a) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not
later than 90 days after the date of the enactment of
this Act [June 12, 2002], all persons (unless exempt
under subsection (g) of section 351A of the Public
Health Service Act [subsec. (g) of this section], as
added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A
of the Public Health Service Act [this section] shall notify the Secretary of Health and Human Services of
such possession. Not later than 30 days after such date
of enactment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary.
‘‘(b) DATE CERTAIN FOR PROMULGATION; EFFECTIVE
DATE REGARDING CRIMINAL AND CIVIL PENALTIES.—Not
later than 180 days after the date of the enactment of
this Act [June 12, 2002], the Secretary of Health and
Human Services shall promulgate an interim final rule
for carrying out section 351A of the Public Health Service Act [this section], subject to subsection (c). Such
interim final rule shall take effect 60 days after the
date on which such rule is promulgated, including for
purposes of—
‘‘(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section
231(a)(5) of this Act; and
‘‘(2) section 351A(i) of the Public Health Service Act
[subsec. (i) of this section] (relating to civil penalties).
‘‘(c) TRANSITIONAL PROVISION REGARDING CURRENT
RESEARCH AND EDUCATION.—The interim final rule
under subsection (b) shall include time frames for the
applicability of the rule that minimize disruption of research or educational projects that involve biological
agents and toxins listed pursuant to section 351A(a)(1)
of the Public Health Service Act [subsec. (a)(1) of this
section] and that were underway as of the effective
date of such rule.’’
EX. ORD. NO. 13546. OPTIMIZING THE SECURITY OF BIOLOGICAL SELECT AGENTS AND TOXINS IN THE UNITED
STATES
Ex. Ord. No. 13546, July 2, 2010, 75 F.R. 39439, provided:

Page 370

By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
SECTION 1. Policy. It is the policy of the United States
that:
(a) A robust and productive scientific enterprise that
utilizes biological select agents and toxins (BSAT) is
essential to national security;
(b) BSAT shall be secured in a manner appropriate to
their risk of misuse, theft, loss, and accidental release;
and
(c) Security measures shall be taken in a coordinated
manner that balances their efficacy with the need to
minimize the adverse impact on the legitimate use of
BSAT.
SEC. 2. Definitions. (a) ‘‘Select Agent Program’’ (SAP)
means the regulatory oversight and administrative activities conducted by the Secretaries of Health and
Human Services and Agriculture and the Attorney General to implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and
the Agricultural Bioterrorism Protection Act of 2002.
(b) ‘‘Select Agent Regulations’’ (SAR) means the Federal regulations found in Part 73 of Title 42 of the Code
of Federal Regulations, Part 331 of Title 7 of the Code
of Federal Regulations, and Part 121 of Title 9 of the
Code of Federal Regulations.
(c) ‘‘Biological Select Agents and Toxins’’ means biological agents and toxins with the potential to pose a
severe threat to public health and safety, animal and
plant health, or animal and plant products and whose
possession, use, and transfer are regulated by the Department of Health and Human Services and the Department of Agriculture under the SAR.
SEC. 3. Findings. (a) The use of BSAT presents the
risk that BSAT might be lost, stolen, or diverted for
malicious purpose. The SAP exists to provide effective
regulatory oversight of the possession, use, and transfer of BSAT that reduces the risk of their misuse or
mishandling. The absence of clearly defined, risk-based
security measures in the SAR/SAP has raised concern
about the need for optimized security and for risk management.
(b) In addition, variations in, and limited coordination of, individual executive departments’ and agencies’ oversight, security practices, and inspections have
raised concerns that the cost and complexity of compliance for those who are registered to work with BSAT
could discourage research or other legitimate activities.
(c) Understanding that research and laboratory work
on BSAT is essential to both public health and national
security, it is in the interest of the United States to address these issues.
SEC. 4. Risk-based Tiering of the Select Agent List. To
help ensure that BSAT are secured according to level of
risk, the Secretaries of Health and Human Services and
Agriculture shall, through their ongoing review of the
biological Select Agents and Toxins List (‘‘Select
Agent List’’) contained in regulations, and no later
than 18 months from the date of this order:
(a) designate a subset of the Select Agent List (Tier
1) that presents the greatest risk of deliberate misuse
with most significant potential for mass casualties or
devastating effects to the economy, critical infrastructure, or public confidence;
(b) explore options for graded protection of Tier 1
agents and toxins as described in subsection (a) of this
section to permit tailored risk management practices
based upon relevant contextual factors; and
(c) consider reducing the overall number of agents
and toxins on the Select Agent List.
SEC. 5. Revision of Regulations, Rules, and Guidance to
Accommodate a Tiered Select Agent List. Consistent with
section 4 of this order, I request that:
(a) The Secretaries of Health and Human Services
and Agriculture, no later than 15 months from the date
of this order, propose amendments to their respective
parts of the SAR that would establish security standards specific to Tier 1 agents and toxins.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) The Secretaries of Health and Human Services
and Agriculture each, no later than 27 months from the
date of this order, promulgate final rules and guidance
that clearly articulate security actions for registrants
who possess, use, or transfer Tier 1 agents and toxins.
SEC. 6. Coordination of Federal Oversight for BSAT Security. To ensure that the policies and practices used to
secure BSAT are harmonized and that the related oversight activities of the Federal Government are coordinated, the heads of executive departments and agencies
identified in section 7(a)(ii) of this order shall:
(a) no later than 6 months from the date of this order,
develop and implement a plan for the coordination of
BSAT security oversight that:
(i) articulates a mechanism for coordinated and reciprocal inspection of and harmonized administrative
practices for facilities registered with the SAP;
(ii) ensures consistent and timely identification and
resolution of BSAT security and compliance issues;
(iii) facilitates information sharing among departments and agencies regarding ongoing oversight and inspection activities; and
(iv) provides for comprehensive and effective Federal
oversight of BSAT security; and
(b) no later than 6 months from the issuance of final
rules and guidance as described in section 5 of this
order, and annually thereafter, review for inconsistent
requirements and revise or rescind, as appropriate, any
regulations, directives, guidance, or policies regarding
BSAT security within their department or agency that
exceed those in the updated SAR and guidance as described in section 5 of this order.
SEC. 7. Implementation. (a) Establishment, Operation,
and Functions of the Federal Experts Security Advisory Panel.
(i) There is hereby established, within the Department of Health and Human Services for administrative
purposes only, the Federal Experts Security Advisory
Panel (Panel), which shall make technical and substantive recommendations on BSAT security concerning the SAP.
(ii) The Panel shall consist of representatives from
the following, who may consult with additional experts
from their department or agency as required:
1. the Department of State;
2. the Department of Defense;
3. the Department of Justice;
4. the Department of Agriculture (Co-Chair);
5. the Department of Commerce;
6. the Department of Health and Human Services
(Co-Chair);
7. the Department of Transportation;
8. the Department of Labor;
9. the Department of Energy;
10. the Department of Veterans Affairs;
11. the Department of Homeland Security;
12. the Environmental Protection Agency;
13. the Office of the Director of National Intelligence;
14. the Office of Science and Technology Policy;
15. the Joint Chiefs of Staff; and
16. any other department or agency designated by
the Co-Chairs.
(iii) To assist the Secretaries of Health and Human
Services and Agriculture and the Attorney General in
implementing the policies set forth in sections 1, 4, 5,
and 6 of this order, the Panel shall, no later than 4
months from the date of this order, provide consensus
recommendations concerning the SAP on:
1. the designation of Tier 1 agents and toxins;
2. reduction in the number of agents on the Select
Agent List;
3. the establishment of appropriate practices to ensure reliability of personnel with access to Tier 1
agents and toxins at registered facilities;
4. the establishment of appropriate practices for
physical security and cyber security for facilities
that possess Tier 1 agents. The Department of Homeland Security shall Chair a Working Group of the
Panel that develops recommended laboratory critical
infrastructure security standards in these areas; and

§ 263

5. other emerging policy issues relevant to the security of BSAT.
Thereafter, the Panel shall continue to provide technical advice concerning the SAP on request.
(iv) If the Panel is unable to reach consensus on recommendations for an issue within its charge, the matter shall be resolved through the interagency policy
committee process led by the National Security Staff.
(v) The Secretaries of Health and Human Services
and Agriculture and the Attorney General shall report
to the Assistant to the President for Homeland Security and Counterterrorism on the consideration and implementation of Panel recommendations concerning
the SAP, including a rationale for failure to implement
any recommendations.
(vi) The Panel shall be chartered for a period of 4
years subject to renewal through the interagency policy committee process led by the National Security
Staff.
(b) To further assist the Secretaries of Health and
Human Services and Agriculture and the Attorney General in implementing the policy set forth in sections 1,
4, 5, and 6 of this order, the National Science Advisory
Board for Biosecurity shall provide technical advice
and serve as a conduit for public consultation, as needed, on topics of relevance to the SAP.
SEC. 8. Sharing of Select Agent Program Information. (a)
Consistent with applicable laws and regulations, the
Secretaries of Health and Human Services and Agriculture and the Attorney General shall, no later than
6 months from the date of this order, develop a process
and the criteria for making SAP information available
to executive departments and agencies when such information is necessary for furthering a public health, safety, security, law enforcement, or national security mission.
(b) SAP information shall continue to be safeguarded
properly and handled securely to minimize the risk of
disclosing sensitive, personal, and other information
protected by the Privacy Act, 5 U.S.C. 552a.
SEC. 9. General Provisions. (a) The National Security
Staff shall, on a biennial basis, review the implementation and effectiveness of this order and refer to the
interagency policy committee process any issues that
require further deliberation or adjudication.
(b) Nothing in this order shall be construed to impair
or otherwise affect the authority granted by law to a
department or agency, or the head thereof, or functions
of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative
proposals.
(c) This order shall be implemented consistent with
applicable law and subject to the availability of appropriations.
(d) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
BARACK OBAMA.

§ 263. Preparation of biological products by Service
(a) The Service may prepare for its own use
any product described in section 262 of this title
and any product necessary to carrying out any
of the purposes of section 241 of this title.
(b) The Service may prepare any product described in section 262 of this title for the use of
other Federal departments or agencies, and public or private agencies and individuals engaged
in work in the field of medicine when such product is not available from establishments licensed under such section.
(July 1, 1944, ch. 373, title III, § 352, 58 Stat. 703.)
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and em-

§ 263a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ployees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
SUBPART 2—CLINICAL LABORATORIES

§ 263a. Certification of laboratories
(a) ‘‘Laboratory’’ or ‘‘clinical laboratory’’ defined
As used in this section, the term ‘‘laboratory’’
or ‘‘clinical laboratory’’ means a facility for the
biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human
body for the purpose of providing information
for the diagnosis, prevention, or treatment of
any disease or impairment of, or the assessment
of the health of, human beings.
(b) Certificate requirement
No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by
the Secretary under this section applicable to
the category of examinations or procedures
which includes such examination or procedure.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a laboratory only if the laboratory
meets the requirements of subsection (d) of
this section.
(2) Term
A certificate issued under this section shall
be valid for a period of 2 years or such shorter
period as the Secretary may establish.
(d) Requirements for certificates
(1) In general
A laboratory may be issued a certificate or
have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e) of
this section, the accreditation body which
accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of
the laboratory examinations and other
procedures performed by the laboratory including—
(I) the number and types of laboratory
examinations and other procedures performed,
(II) the methodologies for laboratory
examinations and other procedures employed, and
(III) the qualifications (educational
background, training, and experience) of
the personnel directing and supervising
the laboratory and performing the laboratory examinations and other procedures, and

Page 372

(iii) that contains such other information as the Secretary may require to determine compliance with this section, and
the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to
the accreditation body which accredited it) a
description of any change in the information
submitted under clause (ii) not later than 6
months after the change was put into effect,
(B) the laboratory provides the Secretary—
(i) with satisfactory assurances that the
laboratory will be operated in accordance
with standards issued by the Secretary
under subsection (f) of this section, or
(ii) with proof of accreditation under
subsection (e) of this section,
(C) the laboratory agrees to permit inspections by the Secretary under subsection (g)
of this section,
(D) the laboratory agrees to make records
available and submit reports to the Secretary as the Secretary may reasonably require, and
(E) the laboratory agrees to treat proficiency testing samples in the same manner
as it treats materials derived from the
human body referred to it for laboratory examinations or other procedures in the ordinary course of business.
(2) Requirements for certificates of waiver
(A) In general
A laboratory which only performs laboratory examinations and procedures described
in paragraph (3) shall be issued a certificate
of waiver or have its certificate of waiver renewed if—
(i) the laboratory submits an application—
(I) in such form and manner as the Secretary shall prescribe,
(II) that describes the characteristics
of the laboratory examinations and
other procedures performed by the laboratory, including the number and types
of laboratory examinations and other
procedures performed, the methodologies
for laboratory examinations and other
procedures employed, and the qualifications (educational background, training,
and experience) of the personnel directing and supervising the laboratory and
performing the laboratory examinations
and other procedures, and
(III) that contains such other information as the Secretary may reasonably require to determine compliance with this
section, and
(ii) the laboratory agrees to make
records available and submit reports to
the Secretary as the Secretary may require.
(B) Changes
If a laboratory makes changes in the examinations and other procedures performed
by it only with respect to examinations and
procedures which are described in paragraph
(3), the laboratory shall report such changes

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

to the Secretary not later than 6 months
after the change has been put into effect. If
a laboratory proposes to make changes in
the examinations and procedures performed
by it such that the laboratory will perform
an examination or procedure not described
in paragraph (3), the laboratory shall report
such change to the Secretary before the
change takes effect.
(C) Effect
Subsections (f) and (g) of this section shall
not apply to a laboratory to which has been
issued a certificate of waiver.
(3) Examinations and procedures
The examinations and procedures identified
in paragraph (2) are laboratory examinations
and procedures that have been approved by the
Food and Drug Administration for home use or
that, as determined by the Secretary, are simple laboratory examinations and procedures
that have an insignificant risk of an erroneous
result, including those that—
(A) employ methodologies that are so simple and accurate as to render the likelihood
of erroneous results by the user negligible,
or
(B) the Secretary has determined pose no
unreasonable risk of harm to the patient if
performed incorrectly.
(4) ‘‘Certificate’’ defined
As used in this section, the term ‘‘certificate’’ includes a certificate of waiver issued
under paragraph (2).
(e) Accreditation
(1) In general
A laboratory may be accredited for purposes
of obtaining a certificate if the laboratory—
(A) meets the standards of an approved accreditation body, and
(B) authorizes the accreditation body to
submit to the Secretary (or such State agency as the Secretary may designate) such
records or other information as the Secretary may require.
(2) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization to be an accreditation
body for the accreditation of laboratories
if—
(i) using inspectors qualified to evaluate
the methodologies used by the laboratories
in performing laboratory examinations
and other procedures, the accreditation
body agrees to inspect a laboratory for
purposes of accreditation with such frequency as determined by 1 Secretary,
(ii) the standards applied by the body in
determining whether or not to accredit a
laboratory are equal to or more stringent
than the standards issued by the Secretary
under subsection (f) of this section,
(iii) there is adequate provision for assuring that the standards of the accreditation body continue to be met by the laboratory,
1 So

in original. Probably should be ‘‘by the’’.

§ 263a

(iv) in the case of any laboratory accredited by the body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any other action
taken against it by the accrediting body,
the accrediting body agrees to submit to
the Secretary the name of such laboratory
within 30 days of the action taken,
(v) the accreditation body agrees to notify the Secretary at least 30 days before it
changes its standards, and
(vi) if the accreditation body has its approval withdrawn by the Secretary, the
body agrees to notify each laboratory accredited by the body of the withdrawal
within 10 days of the withdrawal.
(B) Criteria and procedures
The Secretary shall promulgate criteria
and procedures for approving an accreditation body and for withdrawing such approval
if the Secretary determines that the accreditation body does not meet the requirements
of subparagraph (A).
(C) Effect of withdrawal of approval
If the Secretary withdraws the approval of
an accreditation body under subparagraph
(B), the certificate of any laboratory accredited by the body shall continue in effect for
60 days after the laboratory receives notification of the withdrawal of the approval, except that the Secretary may extend such period for a laboratory if it determines that
the laboratory submitted an application for
accreditation or a certificate in a timely
manner after receipt of the notification of
the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the
laboratory shall continue in effect—
(i) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or
(ii) until the effective date of any action
taken by the Secretary under subsection
(i) of this section.
(D) Evaluations
The Secretary shall evaluate annually the
performance of each approved accreditation
body by—
(i) inspecting under subsection (g) of this
section a sufficient number of the laboratories accredited by such body to allow a
reasonable estimate of the performance of
such body, and
(ii) such other means as the Secretary
determines appropriate.
(3) Omitted
(f) Standards
(1) In general
The Secretary shall issue standards to assure consistent performance by laboratories
issued a certificate under this section of valid
and reliable laboratory examinations and
other procedures. Such standards shall require
each laboratory issued a certificate under this
section—
(A) to maintain a quality assurance and
quality control program adequate and appro-

§ 263a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

priate for the validity and reliability of the
laboratory examinations and other procedures of the laboratory and to meet requirements relating to the proper collection,
transportation, and storage of specimens and
the reporting of results,
(B) to maintain records, equipment, and
facilities necessary for the proper and effective operation of the laboratory,
(C) in performing and carrying out its laboratory examinations and other procedures,
to use only personnel meeting such qualifications as the Secretary may establish for
the direction, supervision, and performance
of examinations and procedures within the
laboratory, which qualifications shall take
into consideration competency, training, experience, job performance, and education
and which qualifications shall, as appropriate, be different on the basis of the type
of examinations and procedures being performed by the laboratory and the risks and
consequences of erroneous results associated
with such examinations and procedures,
(D) to qualify under a proficiency testing
program meeting the standards established
by the Secretary under paragraph (3), and
(E) to meet such other requirements as the
Secretary determines necessary to assure
consistent performance by such laboratories
of accurate and reliable laboratory examinations and procedures.
(2) Considerations
In developing the standards to be issued
under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take
into consideration—
(A) the examinations and procedures performed and the methodologies employed,
(B) the degree of independent judgment involved,
(C) the amount of interpretation involved,
(D) the difficulty of the calculations involved,
(E) the calibration and quality control requirements of the instruments used,
(F) the type of training required to operate
the instruments used in the methodology,
and
(G) such other factors as the Secretary
considers relevant.
(3) Proficiency testing program
(A) In general
The Secretary shall establish standards for
the proficiency testing programs for laboratories issued a certificate under this section
which are conducted by the Secretary, conducted by an organization approved under
subparagraph (C), or conducted by an approved accrediting body. The standards shall
require that a laboratory issued a certificate
under this section be tested for each examination and procedure conducted within a
category of examinations or procedures for
which it has received a certificate, except
for examinations and procedures for which
the Secretary has determined that a proficiency test cannot reasonably be devel-

Page 374

oped. The testing shall be conducted on a
quarterly basis, except where the Secretary
determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not
less often than twice per year).
(B) Criteria
The standards established under subparagraph (A) shall include uniform criteria for
acceptable performance under a proficiency
testing program, based on the available
technology and the clinical relevance of the
laboratory examination or other procedure
subject to such program. The criteria shall
be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall
also include a system for grading proficiency
testing performance to determine whether a
laboratory has performed acceptably for a
particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.
(C) Approved proficiency testing programs
For the purpose of administering proficiency testing programs which meet the
standards established under subparagraph
(A), the Secretary shall approve a proficiency testing program offered by a private
nonprofit organization or a State if the program meets the standards established under
subparagraph (A) and the organization or
State provides technical assistance to laboratories seeking to qualify under the program. The Secretary shall evaluate each
program approved under this subparagraph
annually to determine if the program continues to meet the standards established
under subparagraph (A) and shall withdraw
the approval of any program that no longer
meets such standards.
(D) Onsite testing
The Secretary shall perform, or shall direct a program approved under subparagraph
(C) to perform, onsite proficiency testing to
assure compliance with the requirements of
subsection (d)(5) of this section. The Secretary shall perform, on an onsite or other
basis, proficiency testing to evaluate the
performance of a proficiency testing program approved under subparagraph (C) and
to assure quality performance by a laboratory.
(E) Training, technical assistance, and enhanced proficiency testing
The Secretary may, in lieu of or in addition to actions authorized under subsection
(h), (i), or (j) of this section, require any laboratory which fails to perform acceptably on
an individual examination and procedure or
a category of examination and procedures—
(i) to undertake training and to obtain
the necessary technical assistance to meet
the requirements of the proficency 2 testing program,
2 So

in original. Probably should be ‘‘proficiency’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) to enroll in a program of enhanced
proficiency testing, or
(iii) to undertake any combination of the
training, technical assistance, or testing
described in clauses (i) and (ii).
(F) Testing results
The Secretary shall establish a system to
make the results of the proficiency testing
programs subject to the standards established by the Secretary under subparagraph
(A) available, on a reasonable basis, upon request of any person. The Secretary shall include with results made available under this
subparagraph such explanatory information
as may be appropriate to assist in the interpretation of such results.
(4) National standards for quality assurance in
cytology services
(A) Establishment
The Secretary shall establish national
standards for quality assurance in cytology
services designed to assure consistent performance by laboratories of valid and reliable cytological services.
(B) Standards
The standards established under subparagraph (A) shall include—
(i) the maximum number of cytology
slides that any individual may screen in a
24-hour period,
(ii) requirements that a clinical laboratory maintain a record of (I) the number of
cytology slides screened during each 24hour period by each individual who examines cytology slides for the laboratory, and
(II) the number of hours devoted during
each 24-hour period to screening cytology
slides by such individual,
(iii) criteria for requiring rescreening of
cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II)
focused rescreening of such preparations in
high risk groups, and (III) for each abnormal cytological result, rescreening of all
prior cytological specimens for the patient, if available,
(iv) periodic confirmation and evaluation
of the proficiency of individuals involved
in screening or interpreting cytological
preparations, including announced and unannounced on-site proficiency testing of
such individuals, with such testing to take
place, to the extent practicable, under normal working conditions,
(v) procedures for detecting inadequately
prepared slides, for assuring that no cytological diagnosis is rendered on such
slides, and for notifying referring physicians of such slides,
(vi) requirements that all cytological
screening be done on the premises of a laboratory that is certified under this section,
(vii) requirements for the retention of
cytology slides by laboratories for such periods of time as the Secretary considers
appropriate, and
(viii) standards requiring periodic inspection of cytology services by persons

§ 263a

capable of evaluating the quality of cytology services.
(g) Inspections
(1) In general
The Secretary may, on an announced or unannounced basis, enter and inspect, during
regular hours of operation, laboratories which
have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information
that the Secretary determines have a bearing
on whether the laboratory is being operated in
accordance with this section. As part of such
an inspection the Secretary may copy any
such material or require to it 3 be submitted to
the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in
charge of the laboratory being inspected.
(2) Compliance with requirements and standards
The Secretary shall conduct inspections of
laboratories under paragraph (1) to determine
their compliance with the requirements of
subsection (d) of this section and the standards issued under subsection (f) of this section.
Inspections of laboratories not accredited
under subsection (e) of this section shall be
conducted on a biennial basis or with such
other frequency as the Secretary determines
to be necessary to assure compliance with
such requirements and standards. Inspections
of laboratories accredited under subsection (e)
of this section shall be conducted on such
basis as the Secretary determines is necessary
to assure compliance with such requirements
and standards.
(h) Intermediate sanctions
(1) In general
If the Secretary determines that a laboratory which has been issued a certificate under
this section no longer substantially meets the
requirements for the issuance of a certificate,
the Secretary may impose intermediate sanctions in lieu of the actions authorized by subsection (i) of this section.
(2) Types of sanctions
The intermediate sanctions which may be
imposed under paragraph (1) shall consist of—
(A) directed plans of correction,
(B) civil money penalties in an amount not
to exceed $10,000 for each violation listed in
subsection (i)(1) of this section or for each
day of substantial noncompliance with the
requirements of this section,
(C) payment for the costs of onsite monitoring, or
(D) any combination of the actions described in subparagraphs (A), (B), and (C).
(3) Procedures
The Secretary shall develop and implement
procedures with respect to when and how each
of the intermediate sanctions is to be imposed
under paragraph (1). Such procedures shall
3 So

in original. Probably should be ‘‘require it to’’.

§ 263a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for
appealing determinations relating to the imposition of intermediate sanctions 4
(i) Suspension, revocation, and limitation
(1) In general
Except as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if
the Secretary finds, after reasonable notice
and opportunity for hearing to the owner or
operator of the laboratory, that such owner or
operator or any employee of the laboratory—
(A) has been guilty of misrepresentation in
obtaining the certificate,
(B) has performed or represented the laboratory as entitled to perform a laboratory
examination or other procedure which is not
within a category of laboratory examinations or other procedures authorized in the
certificate,
(C) has failed to comply with the requirements of subsection (d) of this section or the
standards prescribed by the Secretary under
subsection (f) of this section,
(D) has failed to comply with reasonable
requests of the Secretary for—
(i) any information or materials, or
(ii) work on materials,
that the Secretary concludes is necessary to
determine the laboratory’s continued eligibility for its certificate or continued compliance with the Secretary’s standards under
subsection (f) of this section,
(E) has refused a reasonable request of the
Secretary, or any Federal officer or employee duly designated by the Secretary, for
permission to inspect the laboratory and its
operations and pertinent records during the
hours the laboratory is in operation,
(F) has violated or aided and abetted in
the violation of any provisions of this section or of any regulation promulgated thereunder, or
(G) has not complied with an intermediate
sanction imposed under subsection (h) of
this section.
(2) Action before a hearing
If the Secretary determines that—
(A) the failure of a laboratory to comply
with the standards of the Secretary under
subsection (f) of this section presents an imminent and serious risk to human health, or
(B) a laboratory has engaged in an action
described in subparagraph (D) or (E) of paragraph (1),
the Secretary may suspend or limit the certificate of the laboratory before holding a
hearing under paragraph (1) regarding such
failure or refusal. The opportunity for a hearing shall be provided no later than 60 days
from the effective date of the suspension or
limitation. A suspension or limitation under
this paragraph shall stay in effect until the
decision of the Secretary made after the hearing under paragraph (1).
4 So

in original. Probably should be followed by a period.

Page 376

(3) Ineligibility to own or operate laboratories
after revocation
No person who has owned or operated a laboratory which has had its certificate revoked
may, within 2 years of the revocation of the
certificate, own or operate a laboratory for
which a certificate has been issued under this
section. The certificate of a laboratory which
has been excluded from participation under
the medicare program under title XVIII of the
Social Security Act [42 U.S.C. 1395 et seq.] because of actions relating to the quality of the
laboratory shall be suspended for the period
the laboratory is so excluded.
(4) Improper referrals
Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis
shall have its certificate revoked for at least
one year and shall be subject to appropriate
fines and penalties as provided for in subsection (h) of this section.
(j) Injunctions
Whenever the Secretary has reason to believe
that continuation of any activity by a laboratory would constitute a significant hazard to the
public health the Secretary may bring suit in
the district court of the United States for the
district in which such laboratory is situated to
enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity
pending issuance of a final order under this subsection shall be granted without bond by such
court.
(k) Judicial review
(1) Petition
Any laboratory which has had an intermediate sanction imposed under subsection (h) of
this section or has had its certificate suspended, revoked, or limited under subsection
(i) of this section may, at any time within 60
days after the date the action of the Secretary
under subsection (i) or (h) of this section becomes final, file a petition with the United
States court of appeals for the circuit wherein
the laboratory has its principal place of business for judicial review of such action. As soon
as practicable after receipt of the petition, the
clerk of the court shall transmit a copy of the
petition to the Secretary or other officer designated by the Secretary for that purpose. As
soon as practicable after receipt of the copy,
the Secretary shall file in the court the record
on which the action of the Secretary is based,
as provided in section 2112 of title 28.
(2) Additional evidence
If the petitioner applies to the court for
leave to adduce additional evidence, and shows
to the satisfaction of the court that such additional evidence is material and that there
were reasonable grounds for the failure to adduce such evidence in the proceeding before
the Secretary, the court may order such additional evidence (and evidence in rebuttal of
such additional evidence) to be taken before
the Secretary, and to be adduced upon the
hearing in such manner and upon such terms

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and conditions as the court may deem proper.
The Secretary may modify the findings of the
Secretary as to the facts, or make new findings, by reason of the additional evidence so
taken, and the Secretary shall file such modified or new findings, and the recommendations
of the Secretary, if any, for the modification
or setting aside of his original action, with the
return of such additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in
paragraph (1), the court shall have jurisdiction
to affirm the action, or to set it aside in whole
or in part, temporarily or permanently. The
findings of the Secretary as to the facts, if
supported by substantial evidence, shall be
conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any such action
of the Secretary shall be final, subject to review by the Supreme Court of the United
States upon certiorari or certification as provided in section 1254 of title 28.
(l) Sanctions
Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder shall be imprisoned for not
more than one year or fined under title 18, or
both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not
more than 3 years or fined in accordance with
title 18, or both.
(m) Fees
(1) Certificate fees
The Secretary shall require payment of fees
for the issuance and renewal of certificates,
except that the Secretary shall only require a
nominal fee for the issuance and renewal of
certificates of waiver.
(2) Additional fees
The Secretary shall require the payment of
fees for inspections of laboratories which are
not accredited and for the cost of performing
proficiency testing on laboratories which do
not participate in proficiency testing programs approved under subsection (f)(3)(C) of
this section.
(3) Criteria
(A) Fees under paragraph (1)
Fees imposed under paragraph (1) shall be
sufficient to cover the general costs of administering this section, including evaluating and monitoring proficiency testing programs approved under subsection (f) of this
section and accrediting bodies and implementing and monitoring compliance with
the requirements of this section.
(B) Fees under paragraph (2)
Fees imposed under paragraph (2) shall be
sufficient to cover the cost of the Secretary
in carrying out the inspections and proficiency testing described in paragraph (2).
(C) Fees imposed under paragraphs (1) and
(2)
Fees imposed under paragraphs (1) and (2)
shall vary by group or classification of lab-

§ 263a

oratory, based on such considerations as the
Secretary determines are relevant, which
may include the dollar volume and scope of
the testing being performed by the laboratories.
(n) Information
On April 1, 1990 and annually thereafter, the
Secretary shall compile and make available to
physicians and the general public information,
based on the previous calendar year, which the
Secretary determines is useful in evaluating the
performance of a laboratory, including—
(1) a list of laboratories which have been
convicted under Federal or State laws relating
to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories—
(A) which have had their certificates revoked, suspended, or limited under subsection (i) of this section, or
(B) which have been the subject of a sanction under subsection (l) of this section,
together with a statement of the reasons for
the revocation, suspension, limitation, or
sanction,
(3) a list of laboratories subject to intermediate sanctions under subsection (h) of this
section together with a statement of the reasons for the sanctions,
(4) a list of laboratories whose accreditation
has been withdrawn or revoked together with
a statement of the reasons for the withdrawal
or revocation,
(5) a list of laboratories against which the
Secretary has taken action under subsection
(j) of this section together with a statement of
the reasons for such action, and
(6) a list of laboratories which have been excluded from participation under title XVIII or
XIX of the Social Security Act [42 U.S.C. 1395
et seq., 1396 et seq.].
The information to be compiled under paragraphs (1) through (6) shall be information for
the calendar year preceding the date the information is to be made available to the public and
shall be accompanied by such explanatory information as may be appropriate to assist in the
interpretation of the information compiled
under such paragraphs.
(o) Delegation
In carrying out this section, the Secretary
may, pursuant to agreement, use the services or
facilities of any Federal or State or local public
agency or nonprofit private organization, and
may pay therefor in advance or by way of reimbursement, and in such installments, as the Secretary may determine.
(p) State laws
(1) Except as provided in paragraph (2), nothing in this section shall be construed as affecting the power of any State to enact and enforce
laws relating to the matters covered by this section to the extent that such laws are not inconsistent with this section or with the regulations
issued under this section.
(2) If a State enacts laws relating to matters
covered by this section which provide for requirements equal to or more stringent than the

§ 263a–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

requirements of this section or than the regulations issued under this section, the Secretary
may exempt clinical laboratories in that State
from compliance with this section.
(q) Consultations
In carrying out this section, the Secretary
shall consult with appropriate private organizations and public agencies.
(July 1, 1944, ch. 373, title III, § 353, as added Pub.
L. 90–174, § 5(a), Dec. 5, 1967, 81 Stat. 536; amended
Pub. L. 100–578, § 2, Oct. 31, 1988, 102 Stat. 2903;
Pub. L. 105–115, title I, § 123(h), Nov. 21, 1997, 111
Stat. 2324.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (i)(3)
and (n)(6), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles XVIII and XIX of the Social Security
Act are classified generally to subchapters XVIII (§ 1395
et seq.) and XIX (§ 1396 et seq.), respectively, of chapter
7 of this title. For complete classification of this Act to
the Code, see section 1305 of this title and Tables.
CODIFICATION
Subsec. (e)(3) of this section, which required the Secretary to annually prepare and submit to certain committees of Congress a report describing the results of
the evaluation conducted under subsec. (e)(2)(D) of this
section, terminated, effective May 15, 2000, pursuant to
section 3003 of Pub. L. 104–66, as amended, set out as a
note under section 1113 of Title 31, Money and Finance.
See, also, page 96 of House Document No. 103–7.
AMENDMENTS
1997—Subsec. (d)(3). Pub. L. 105–115 amended heading
and text of par. (3) generally. Prior to amendment, text
read as follows: ‘‘The examinations and procedures
identified in paragraph (2) are simple laboratory examinations and procedures which, as determined by the
Secretary, have an insignificant risk of an erroneous
result, including those which—
‘‘(A) have been approved by the Food and Drug Administration for home use,
‘‘(B) employ methodologies that are so simple and
accurate as to render the likelihood of erroneous results negligible, or
‘‘(C) the Secretary has determined pose no reasonable risk of harm to the patient if performed incorrectly.’’
1988—Pub. L. 100–578 substituted ‘‘Certification of laboratories’’ for ‘‘Licensing of laboratories’’ in section
catchline, and amended text generally, revising and restating as subsecs. (a) to (q) provisions of former subsecs. (a) to (l).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105–115 effective 90 days after
Nov. 21, 1997, except as otherwise provided, see section
501 of Pub. L. 105–115, set out as a note under section 321
of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1988 AMENDMENT; EXCEPTIONS;
CONTINUING APPLICABILITY
Section 3 of Pub. L. 100–578 provided that: ‘‘Subsections (g)(1), (h), (i), (j), (k), (l), and (m) of section 353
of the Public Health Service Act [this section], as
amended by section 101 [probably means section 2 of
Pub. L. 100–578], shall take effect January 1, 1989, except that any reference in such subsections to the
standards established under subsection (f) shall be considered a reference to the standards established under
subsection (d) of such section 353, as in effect on December 31, 1988. During the period beginning January 1,
1989, and ending December 31, 1989, subsections (a)
through (d) and subsection (i) through (l) of such section 353 as in effect on December 31, 1988, shall continue

Page 378

to apply to clinical laboratories. The remaining subsections of such section 353, as so amended, shall take
effect January 1, 1990, except that subsections (f)(1)(C)
and (g)(2) shall take effect July 1, 1991, with respect to
laboratories which were not subject to the requirements of such section 353 as in effect on December 31,
1988.’’
EFFECTIVE DATE
Section 5(b) of Pub. L. 90–174 provided that: ‘‘The
amendment made by subsection (a) [enacting this section] shall become effective on the first day of the thirteenth month after the month [December 1967] in which
it is enacted, except that the Secretary of Health, Education, and Welfare may postpone such effective date
for such additional period as he finds necessary, but not
beyond the first day of the 19th month after such
month [December 1967] in which the amendment is enacted.’’
STUDIES
Section 4 of Pub. L. 100–578 directed Secretary to conduct studies and submit report to Congress, not later
than May 1, 1990, relating to the reliability and quality
control procedures of clinical laboratory testing programs and the effect of errors in the testing procedures
and results on the diagnosis and treatment of patients.

§ 263a–1. Assisted reproductive technology programs
(a) In general
Effective 2 years after October 24, 1992, each
assisted reproductive technology (as defined in
section 263a–7 1 of this title) program shall annually report to the Secretary through the Centers
for Disease Control—
(1) pregnancy success rates achieved by such
program through each assisted reproductive
technology, and
(2) the identity of each embryo laboratory
(as defined in section 263a–7 1 of this title) used
by such program and whether the laboratory
is certified under section 263a–2 of this title or
has applied for such certification.
(b) Pregnancy success rates
(1) In general
For purposes of subsection (a)(1) of this section, the Secretary shall, in consultation with
the organizations referenced in subsection (c)
of this section, define pregnancy success rates
and shall make public any proposed definition
in such manner as to facilitate comment from
any person (including any Federal or other
public agency) during its development.
(2) Definition
In developing the definition of pregnancy
success rates, the Secretary shall take into account the effect on success rates of age, diagnosis, and other significant factors and shall
include in such rates—
(A) the basic live birth rate calculated for
each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of
pregnancies which result in live births by
the number of ovarian stimulation procedures attempted by such program, and
(B) the live birth rate per successful oocyte retrieval procedure calculated for each
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

assisted reproductive technology performed
by an assisted reproductive technology program by dividing the number of pregnancies
which result in live births by the number of
successful oocyte retrieval procedures performed by such program.
(c) Consultation
In developing the definition under subsection
(b) of this section, the Secretary shall consult
with appropriate consumer and professional organizations with expertise in using, providing,
and evaluating professional services and embryo
laboratories associated with assisted reproductive technologies.
(Pub. L. 102–493, § 2, Oct. 24, 1992, 106 Stat. 3146.)
REFERENCES IN TEXT
Section 263a–7 of this title, referred to in subsec. (a),
was in the original ‘‘section 7’’ meaning section 7 of
Pub. L. 102–493, which was translated as reading section
8 to reflect the probable intent of Congress, because
definitions are contained in section 8 instead of section
7.
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
EFFECTIVE DATE
Section 9 of Pub. L. 102–493 provided that: ‘‘This Act
[enacting this section, sections 263a–2 to 263a–7 of this
title, and provisions set out as a note under section 201
of this title] shall take effect upon the expiration of 2
years after the date of the enactment of this Act [Oct.
24, 1992].’’

§ 263a–2. Certification of embryo laboratories
(a) In general
(1) Development
Not later than 2 years after October 24, 1992,
the Secretary, through the Centers for Disease
Control, shall develop a model program for the
certification of embryo laboratories (referred
to in this section as a ‘‘certification program’’) to be carried out by the States.
(2) Consultation
In developing the certification program
under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using,
providing, and evaluating professional services
and embryo laboratories associated with the
assisted reproductive technology programs.
(b) Distribution
The Secretary shall distribute a description of
the certification program to—
(1) the Governor of each State,
(2) the presiding officers of each State legislature,
(3) the public health official of each State,
and
(4) the official responsible in each State for
the operation of the State’s contract with the
Secretary under section 1395aa of this title,

§ 263a–2

and shall encourage such officials to assist in
the State adopting such program.
(c) Requirements
The certification program shall include the
following requirements:
(1) Administration
The certification program shall be administered by the State and shall provide for the inspection and certification of embryo laboratories in the State by the State or by approved
accreditation organizations.
(2) Application requirements
The certification program shall provide for
the submission of an application to a State by
an embryo laboratory for certification, in such
form as may be specified by the State. Such an
application shall include—
(A) assurances satisfactory to the State
that the embryo laboratory will be operated
in accordance with the standards under subsection (d) of this section,
(B) a report to the State identifying the
assisted reproductive technology programs
with which the laboratory is associated, and
(C) such other information as the State
finds necessary.
An embryo laboratory which meets the requirements of section 263a of this title shall,
for the purposes of subparagraph (A) be considered in compliance with the standards referred
to in such subparagraph which are the same as
the standards in effect under section 263a of
this title.
(d) Standards
The certification program shall include the
following standards developed by the Secretary:
(1) A standard to assure consistent performance of procedures by each embryo laboratory
certified under the certification program or by
an approved accreditation organization in a
State which has not adopted the certification
program.
(2) A standard for a quality assurance and a
quality control program to assure valid, reliable, and reproduceable 1 procedures in the laboratory.
(3) A standard for the maintenance of
records (on a program by program basis) on
laboratory tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and
preparation of any standards or controls, criteria for acceptable and unacceptable outcomes, criteria for sample rejection, and procedures for safe sample disposal.
(4) A standard for the maintenance of written records on personnel and facilities necessary for proper and effective operation of the
laboratory, schedules of preventive maintenance, function verification for equipment,
and the release of such records to the State
upon demand.
(5) A standard for the use of such personnel
who meet such qualifications as the Secretary
may develop.
1 So

in original. Probably should be ‘‘reproducible’’.

§ 263a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Certification under State programs
A State may qualify to adopt the certification
program if the State has submitted an application to the Secretary to adopt such program and
the Secretary has approved the application.
Such an application shall include—
(1) assurances by the State satisfactory to
the Secretary that the certification program
within the State meets the requirements of
this section,
(2) an agreement to make such reports as the
Secretary may require, and
(3) information about any proposed use of
accreditation organizations under subsection
(g) 2 of this section.
(f) Use of accreditation organizations
A State which has adopted the certification
program may use accreditation organizations
approved under section 263a–3 of this title to inspect and certify embryo laboratories.
(g) Inspections
(1) In general
A State which qualifies to adopt the certification program within the State shall conduct
inspections in accordance with paragraph (2)
to determine if laboratories in the State meet
the requirements of such program. Such inspections shall be carried out by the State or
by accreditation organizations used by the
State under subsection (g) 2 of this section.
(2) Requirements
Inspections carried out under paragraph (1)
shall—
(A) be periodic and unannounced, or
(B) be announced in such circumstances as
the Secretary determines will not diminish
the likelihood of discovering deficiencies in
the operations of a laboratory.
Before making a determination under subparagraph (B), the Secretary shall make public, in
such manner as to facilitate comment from
any person (including any Federal or other
public agency), a proposal indicating the circumstances under which announced inspections would be permitted.
(3) Results
The specific findings, including deficiencies,
identified in an inspection carried out under
paragraph (1) and any subsequent corrections
to those deficiencies shall be announced and
made available to the public upon request beginning no later than 60 days after the date of
the inspection.
(h) Validation inspections
(1) In general
The Secretary may enter and inspect, during
regular hours of operation, embryo laboratories—
(A) which have been certified by a State
under the certification program, or
(B) which have been certified by an accreditation organization approved by the Secretary under section 263a–3 of this title,
for the purpose of determining whether the
laboratory is being operated in accordance
2 So

in original. Probably should be subsection ‘‘(f)’’.

Page 380

with the standards in subsection (d) of this
section.
(2) Access to facilities and records
In conducting an inspection of an embryo
laboratory under paragraph (1), the Secretary
shall have access to all facilities, equipment,
materials, records, and information which the
Secretary determines is necessary to determine if such laboratory is being operated in
accordance with the standards in subsection
(d) of this section. As part of such an inspection, the Secretary may copy any material,
record, or information inspected or require it
to be submitted to the Secretary. Such an inspection may be made only upon the presentation of identification to the owner, operator,
or agent in charge of the laboratory being inspected.
(3) Failure to comply
If the Secretary determines as a result of an
inspection under paragraph (1) that the embryo laboratory is not in compliance with the
standards in subsection (d) of this section, the
Secretary shall—
(A) notify the State in which the laboratory is located and, if appropriate, the accreditation organization which certified the
laboratory,
(B) make available to the public the results of the inspection,
(C) conduct additional inspections of other
embryo laboratories under paragraph (1) to
determine if—
(i) such State in carrying out the certification program is reliably identifying the
deficiencies of such laboratory, or
(ii) the accreditation organization which
certified such laboratories is reliably identifying such deficencies,3 and
(D) if the Secretary determines—
(i) that such State in carrying out the
certification program has not met the requirements applicable to such program, or
(ii) the accreditation organization which
certified such laboratory has not met the
requirements of section 263a–3 of this title,
the Secretary may revoke the approval of the
State certification program or revoke the approval of such accreditation organization.
(i) Limitation
(1) Secretary
In developing the certification program, the
Secretary may not establish any regulation,
standard, or requirement which has the effect
of exercising supervision or control over the
practice of medicine in assisted reproductive
technology programs.
(2) State
In adopting the certification program, a
State may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.
(j) Term
The term of a certification issued by a State
or an accreditation organization in a State shall
3 So

in original. Probably should be ‘‘deficiencies,’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

be prescribed by the Secretary in the certification program and shall be valid for a period of
time to be defined by the Secretary through the
public comment process described in subsection
(h)(2) 4 of this section. The Secretary shall provide an application for recertification to be submitted at the time of changes in the ownership
of a certified laboratory or changes in the administration of such a laboratory.
(Pub. L. 102–493, § 3, Oct. 24, 1992, 106 Stat. 3146.)
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.

(d) Transition
If the Secretary revokes approval under section 263a–2(i)(3)(D) 3 of this title of an accreditation organization after an evaluation under subsection (c) of this section, the certification of
any embryo laboratory accredited by the organization shall continue in effect for 60 days after
the laboratory is notified by the Secretary of
the withdrawal of approval, except that the Secretary may extend the period during which the
certification shall remain in effect if the Secretary determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.
(Pub. L. 102–493, § 4, Oct. 24, 1992, 106 Stat. 3150.)

CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
EFFECTIVE DATE
Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.

§ 263a–3. Accreditation organizations
(a) Approval of accreditation organizations
Not later than 2 years after October 24, 1992,
the Secretary, through the Centers for Disease
Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify embryo laboratories.
The procedures shall require an application to
the Secretary by an accreditation organization
for approval. An accreditation organization
which has received such an approval—
(1) may be used by States in the certification program under section 263a–2 of this
title to inspect and certify embryo laboratories, or
(2) may certify embryo laboratories in
States which have not adopted such a certification program.
(b) Criteria and procedures
The criteria and procedures promulgated
under subsection (a) of this section shall include—
(1) requirements for submission of such reports and the maintenance of such records as
the Secretary or a State may require, and
(2) requirements for the conduct of inspections under section 263a–2(h) 1 of this title.
(c) Evaluations
The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—
(1) inspecting under section 263a–2(i) 2 of this
title a sufficient number of embryo laboratories accredited by such an organization to
allow a reasonable estimate of the performance of such organization, and
(2) such other means as the Secretary determines to be appropriate.
4 So

in original. Probably should be subsection ‘‘(g)(2)’’.
in original. Probably should be section ‘‘263a–2(g)’’.
2 So in original. Probably should be section ‘‘263a–2(h)’’.

§ 263a–4

CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
EFFECTIVE DATE
Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.

§ 263a–4. Certification revocation and suspension
(a) In general
A certification issued by a State or an accreditation organization for an embryo laboratory
shall be revoked or suspended if the State or organization finds, on the basis of inspections and
after reasonable notice and opportunity for
hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory—
(1) has been guilty of misrepresentation in
obtaining the certification,
(2) has failed to comply with any standards
under section 263a–2 of this title applicable to
the certification, or
(3) has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and
records.
(b) Effect
If the certification of an embryo laboratory is
revoked or suspended, the certification of the
laboratory shall continue in effect for 60 days
after the laboratory receives notice of the revocation or suspension. If the certification of an
embryo laboratory is revoked or suspended, the
laboratory may apply for recertification after
one year after the date of the revocation or suspension.
(Pub. L. 102–493, § 5, Oct. 24, 1992, 106 Stat. 3150.)
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.

1 So

3 So

in original. Probably should be section ‘‘263a–2(h)(3)(D)’’.

§ 263a–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.

§ 263a–5. Publication
The Secretary, through the Centers for Disease Control, shall not later than 3 years after
October 24, 1992, and annually thereafter publish
and distribute to the States and the public—
(1)(A) 1 pregnancy success rates reported to
the Secretary under section 263a–1(a)(1) of this
title and, in the case of an assisted reproductive technology program which failed to report one or more success rates as required
under such section, the name of each such program and each pregnancy success rate which
the program failed to report, and
(B) from information reported under section
263a–1(a)(2) of this title—
(i) the identity of each embryo laboratory
in a State which has adopted the certification program under such program and
whether such laboratory is certified under
section 263a–2 of this title,
(ii) the identity of each embryo laboratory
in a State which has not adopted such certification program and which has been certified by an accreditation organization approved by the Secretary under section 263a–3
of this title, and
(iii) in the case of an embryo laboratory
which is not certified under section 263a–2 of
this title or certified by an accreditation organization approved by the Secretary under
section 263a–3 of this title, whether the laboratory applied for certification.
(Pub. L. 102–493, § 6, Oct. 24, 1992, 106 Stat. 3151.)
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
EFFECTIVE DATE
Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.

§ 263a–6. Fees
The Secretary may require the payment of
fees for the purpose of, and in an amount sufficient to cover the cost of, administering sections 263a–1 to 263a–7 of this title. A State operating a program under section 263a–2 of this title
may require the payment of fees for the purpose
of, and in an amount sufficient to cover the
costs of, administering its program.
(Pub. L. 102–493, § 7, Oct. 24, 1992, 106 Stat. 3151.)
REFERENCES IN TEXT
Sections 263a–1 to 263a–7 of this title, referred to in
text, was in the original ‘‘this Act’’, meaning Pub. L.
1 So

in original. No par. (2) has been enacted.

Page 382

102–493, Oct. 24, 1992, 106 Stat. 3146, known as the Fertility Clinic Success Rate and Certification Act of 1992,
which enacted sections 263a–1 to 263a–7 of this title and
provisions set out as notes under sections 201 and 263a–1
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section 201
of this title and Tables.
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.
EFFECTIVE DATE
Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.

§ 263a–7. Definitions
For purposes of sections 263a–1 to 263a–7 of this
title:
(1) Assisted reproductive technology
The term ‘‘assisted reproductive technology’’ means all treatments or procedures
which include the handling of human oocytes
or embryos, including in vitro fertilization,
gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific
technologies as the Secretary may include in
this definition, after making public any proposed definition in such manner as to facilitate comment from any person (including any
Federal or other public agency).
(2) Embryo laboratory
The term ‘‘embryo laboratory’’ means a facility in which human oocytes are subject to
assisted reproductive technology treatment or
procedures based on manipulation of oocytes
or embryos which are subject to implantation.
(3) Secretary
The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(Pub. L. 102–493, § 8, Oct. 24, 1992, 106 Stat. 3151.)
REFERENCES IN TEXT
Sections 263a–1 to 263a–7 of this title, referred to in
text, was in the original ‘‘this Act’’, meaning Pub. L.
102–493, Oct. 24, 1992, 106 Stat. 3146, known as the Fertility Clinic Success Rate and Certification Act of 1992,
which enacted sections 263a–1 to 263a–7 of this title and
provisions set out as notes under sections 201 and 263a–1
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section 201
of this title and Tables.
CODIFICATION
Section was enacted as part of the Fertility Clinic
Success Rate and Certification Act of 1992, and not as
part of the Public Health Service Act which comprises
this chapter.
EFFECTIVE DATE
Section effective upon expiration of 2 years after Oct.
24, 1992, see section 9 of Pub. L. 102–493, set out as a
note under section 263a–1 of this title.
SUBPART 3—MAMMOGRAPHY FACILITIES

PRIOR PROVISIONS
A prior subpart 3 of part F of title III of the Public
Health Service Act, comprising this subpart, was re-

Page 383

TITLE 42—THE PUBLIC HEALTH AND WELFARE

numbered subchapter C of chapter V of the Federal
Food, Drug, and Cosmetic Act, by Pub. L. 101–629,
§ 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by
Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779, and
is classified to part C (§ 360hh et seq.) of subchapter V
of chapter 9 of Title 21, Food and Drugs.

§ 263b. Certification of mammography facilities
(a) Definitions
As used in this section:
(1) Accreditation body
The term ‘‘accreditation body’’ means a
body that has been approved by the Secretary
under subsection (e)(1)(A) of this section to accredit mammography facilities.
(2) Certificate
The term ‘‘certificate’’ means the certificate
described in subsection (b)(1) of this section.
(3) Facility
(A) In general
The term ‘‘facility’’ means a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician,
or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities. Such term does not include a facility of the Department of Veterans Affairs.
(B) Activities
For the purposes of this section, the activities of a facility include the operation of
equipment to produce the mammogram, the
processing of the film, the initial interpretation of the mammogram and the viewing
conditions for that interpretation. Where
procedures such as the film processing, or
the interpretation of the mammogram are
performed in a location different from where
the mammogram is performed, the facility
performing the mammogram shall be responsible for meeting the quality standards described in subsection (f) of this section.
(4) Inspection
The term ‘‘inspection’’ means an onsite evaluation of the facility by the Secretary, or
State or local agency on behalf of the Secretary.
(5) Mammogram
The term ‘‘mammogram’’ means a radiographic image produced through mammography.
(6) Mammography
The term ‘‘mammography’’ means radiography of the breast.
(7) Survey
The term ‘‘survey’’ means an onsite physics
consultation and evaluation performed by a
medical physicist as described in subsection
(f)(1)(E) of this section.
(8) Review physician
The term ‘‘review physician’’ means a physician as prescribed by the Secretary under subsection (f)(1)(D) of this section who meets such
additional requirements as may be established
by an accreditation body under subsection (e)

§ 263b

of this section and approved by the Secretary
to review clinical images under subsection
(e)(1)(B)(i) of this section on behalf of the accreditation body.
(b) Certificate requirement
(1) Certificate
No facility may conduct an examination or
procedure described in paragraph (2) involving
mammography after October 1, 1994, unless the
facility obtains—
(A) a certificate or a temporary renewal
certificate—
(i) that is issued, and, if applicable, renewed, by the Secretary in accordance
with paragraphs 1 (1) or (2) of subsection (c)
of this section;
(ii) that is applicable to the examination
or procedure to be conducted; and
(iii) that is displayed prominently in
such facility; or
(B) a provisional certificate or a limited
provisional certificate—
(i) that is issued by the Secretary in accordance with paragraphs (3) and (4) of
subsection (c) of this section;
(ii) that is applicable to the examination
or procedure to be conducted; and
(iii) that is displayed prominently in
such facility.
The reference to a certificate in this section
includes a temporary renewal certificate, provisional certificate, or a limited provisional
certificate.
(2) Examination or procedure
A facility shall obtain a certificate in order
to—
(A) operate radiological equipment that is
used to image the breast;
(B) provide for the interpretation of a
mammogram produced by such equipment at
the facility or under arrangements with a
qualified individual at a facility different
from where the mammography examination
is performed; and
(C) provide for the processing of film produced by such equipment at the facility or
under arrangements with a qualified individual at a facility different from where the
mammography examination is performed.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a facility if the person or agent described in subsection (d)(1)(A) of this section
meets the applicable requirements of subsection (d)(1) of this section with respect to
the facility. The Secretary may issue or renew
a certificate under this paragraph for not
more than 3 years.
(2) Temporary renewal certificate
The Secretary may issue a temporary renewal certificate, for a period of not to exceed
45 days, to a facility seeking reaccreditation if
the accreditation body has issued an accreditation extension, for a period of not to exceed
45 days, for any of the following:
1 So

in original. Probably should be ‘‘paragraph’’.

§ 263b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) The facility has submitted the required
materials to the accreditation body within
the established time frames for the submission of such materials but the accreditation
body is unable to complete the reaccreditation process before the certification expires.
(B) The facility has acquired additional or
replacement equipment, or has had significant personnel changes or other unforeseen
situations that have caused the facility to
be unable to meet reaccreditation timeframes, but in the opinion of the accreditation body have not compromised the quality
of mammography.
(3) Limited provisional certificate
The Secretary may, upon the request of an
accreditation body, issue a limited provisional
certificate to an entity to enable the entity to
conduct examinations for educational purposes while an onsite visit from an accreditation body is in progress. Such certificate shall
be valid only during the time the site visit
team from the accreditation body is physically in the facility, and in no case shall be
valid for longer than 72 hours. The issuance of
a certificate under this paragraph, shall not
preclude the entity from qualifying for a provisional certificate under paragraph (4).
(4) Provisional certificate
The Secretary may issue a provisional certificate for an entity to enable the entity to
qualify as a facility. The applicant for a provisional certificate shall meet the requirements
of subsection (d)(1) of this section, except providing information required by clauses (iii)
and (iv) of subsection (d)(1)(A) of this section.
A provisional certificate may be in effect no
longer than 6 months from the date it is issued, except that it may be extended once for
a period of not more than 90 days if the owner,
lessor, or agent of the facility demonstrates to
the Secretary that without such extension access to mammography in the geographic area
served by the facility would be significantly
reduced and if the owner, lessor, or agent of
the facility will describe in a report to the
Secretary steps that will be taken to qualify
the facility for certification under subsection
(b)(1) of this section.
(d) Application for certificate
(1) Submission
The Secretary may issue or renew a certificate for a facility if—
(A) the person who owns or leases the facility or an authorized agent of the person,
submits to the Secretary, in such form and
manner as the Secretary shall prescribe, an
application that contains at a minimum—
(i) a description of the manufacturer,
model, and type of each x-ray machine,
image receptor, and processor operated in
the performance of mammography by the
facility;
(ii) a description of the procedures currently used to provide mammography at
the facility, including—
(I) the types of procedures performed
and the number of such procedures performed in the prior 12 months;

Page 384

(II) the methodologies for mammography; and
(III) the names and qualifications (educational background, training, and experience) of the personnel performing
mammography and the physicians reading and interpreting the results from the
procedures;
(iii) proof of on-site survey by a qualified
medical physicist as described in subsection (f)(1)(E) of this section; and
(iv) proof of accreditation in such manner as the Secretary shall prescribe; and
(B) the person or agent submits to the Secretary—
(i) a satisfactory assurance that the facility will be operated in accordance with
standards established by the Secretary
under subsection (f) of this section to assure the safety and accuracy of mammography;
(ii) a satisfactory assurance that the facility will—
(I) permit inspections under subsection
(g) of this section;
(II) make such records and information
available, and submit such reports, to
the Secretary as the Secretary may require; and
(III) update the information submitted
under subparagraph (A) or assurances
submitted under this subparagraph on a
timely basis as required by the Secretary; and
(iii) such other information as the Secretary may require.
An applicant shall not be required to provide
in an application under subparagraph (A) any
information which the applicant has supplied
to the accreditation body which accredited the
applicant, except as required by the Secretary.
(2) Appeal
If the Secretary denies an application for
the certification of a facility submitted under
paragraph (1)(A), the Secretary shall provide
the owner or lessor of the facility or the agent
of the owner or lessor who submitted such application—
(A) a statement of the grounds on which
the denial is based, and
(B) an opportunity for an appeal in accordance with the procedures set forth in regulations of the Secretary published at part 498
of title 42, Code of Federal Regulations.
(3) Effect of denial
If the application for the certification of a
facility is denied, the facility may not operate
unless the denial of the application is overturned at the conclusion of the administrative
appeals process provided in the regulations referred to in paragraph (2)(B).
(e) Accreditation
(1) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization or State agency to accredit facilities for purposes of subsection

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d)(1)(A)(iv) of this section if the accreditation body meets the standards for accreditation established by the Secretary as described in subparagraph (B) and provides the
assurances required by subparagraph (C).
(B) Standards
The Secretary shall establish standards for
accreditation bodies, including—
(i) standards that require an accreditation body to perform—
(I) a review of clinical images from
each facility accredited by such body not
less often than every 3 years which review will be made by qualified review
physicians; and
(II) a review of a random sample of
clinical images from such facilities in
each 3-year period beginning October 1,
1994, which review will be made by qualified review physicians;
(ii) standards that prohibit individuals
conducting the reviews described in clause
(i) from maintaining any relationship to
the facility undergoing review which
would constitute a conflict of interest;
(iii) standards that limit the imposition
of fees for accreditation to reasonable
amounts;
(iv) standards that require as a condition
of accreditation that each facility undergo
a survey at least annually by a medical
physicist as described in subsection
(f)(1)(E) of this section to ensure that the
facility meets the standards described in
subparagraphs (A) and (B) of subsection
(f)(1) of this section;
(v) standards that require monitoring
and evaluation of such survey, as prescribed by the Secretary;
(vi) standards that are equal to standards established under subsection (f) of
this section which are relevant to accreditation as determined by the Secretary; and
(vii) such additional standards as the
Secretary may require.
(C) Assurances
The accrediting body shall provide the
Secretary satisfactory assurances that the
body will—
(i) comply with the standards as described in subparagraph (B);
(ii) comply with the requirements described in paragraph (4);
(iii) submit to the Secretary the name of
any facility for which the accreditation
body denies, suspends, or revokes accreditation;
(iv) notify the Secretary in a timely
manner before the accreditation body
changes the standards of the body;
(v) notify each facility accredited by the
accreditation body if the Secretary withdraws approval of the accreditation body
under paragraph (2) in a timely manner;
and
(vi) provide such other additional information as the Secretary may require.
(D) Regulations
Not later than 9 months after October 27,
1992, the Secretary shall promulgate regula-

§ 263b

tions under which the Secretary may approve an accreditation body.
(2) Withdrawal of approval
(A) In general
The Secretary shall promulgate regulations under which the Secretary may withdraw the approval of an accreditation body
if the Secretary determines that the accreditation body does not meet the standards
under subparagraph (B) of paragraph (1), the
requirements of clauses (i) through (vi) of
subparagraph (C) of paragraph (1), or the requirements of paragraph (4).
(B) Effect of withdrawal
If the Secretary withdraws the approval of
an accreditation body under subparagraph
(A), the certificate of any facility accredited
by the body shall continue in effect until the
expiration of a reasonable period, as determined by the Secretary, for such facility to
obtain another accreditation.
(3) Accreditation
To be accredited by an approved accreditation body a facility shall meet—
(A) the standards described in paragraph
(1)(B) which the Secretary determines are
applicable to the facility, and
(B) such other standards which the accreditation body may require.
(4) Compliance
To ensure that facilities accredited by an accreditation body will continue to meet the
standards of the accreditation body, the accreditation body shall—
(A) make onsite visits on an annual basis
of a sufficient number of the facilities accredited by the body to allow a reasonable
estimate of the performance of the body; and
(B) take such additional measures as the
Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be
made after providing such notice as the Secretary may require.
(5) Revocation of accreditation
If an accreditation body revokes the accreditation of a facility, the certificate of the facility shall continue in effect until such time as
may be determined by the Secretary.
(6) Evaluation and report
(A) Evaluation
The Secretary shall evaluate annually the
performance of each approved accreditation
body by—
(i) inspecting under subsection (g)(2) of
this section a sufficient number of the facilities accredited by the body to allow a
reasonable estimate of the performance of
the body; and
(ii) such additional means as the Secretary determines to be appropriate.
(B) Report
The Secretary shall annually prepare and
submit to the Committee on Labor and
Human Resources of the Senate and the
Committee on Energy and Commerce of the

§ 263b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

House of Representatives a report that describes the results of the evaluation conducted in accordance with subparagraph (A).
(f) Quality standards
(1) In general
The standards referred to in subsection
(d)(1)(B)(i) of this section are standards established by the Secretary which include—
(A) standards that require establishment
and maintenance of a quality assurance and
quality control program at each facility
that is adequate and appropriate to ensure
the reliability, clarity, and accuracy of interpretation of mammograms and standards
for appropriate radiation dose;
(B) standards that require use of radiological equipment specifically designed for
mammography, including radiologic standards and standards for other equipment and
materials used in conjunction with such
equipment;
(C) a requirement that personnel who perform mammography—
(i)(I) be licensed by a State to perform
radiological procedures; or
(II) be certified as qualified to perform
radiological procedures by an organization
described in paragraph (2)(A); and
(ii) during the 2-year period beginning
October 1, 1994, meet training standards
for personnel who perform mammography
or meet experience requirements which
shall at a minimum include 1 year of experience in the performance of mammography; and
(iii) upon the expiration of such 2-year
period meet minimum training standards
for personnel who perform mammograms;
(D) a requirement that mammograms be
interpreted by a physician who is certified
as qualified to interpret radiological procedures, including mammography—
(i)(I) by a board described in paragraph
(2)(B); or
(II) by a program that complies with the
standards described in paragraph (2)(C);
and
(ii) who meets training and continuing
medical education requirements as established by the Secretary;
(E) a requirement that individuals who
survey mammography facilities be medical
physicists—
(i) licensed or approved by a State to
perform such surveys, reviews, or inspections for mammography facilities;
(ii) certified in diagnostic radiological
physics or certified as qualified to perform
such surveys by a board as described in
paragraph (2)(D); or
(iii) in the first 5 years after October 27,
1992, who meet other criteria established
by the Secretary which are comparable to
the criteria described in clause (i) or (ii);
(F) a requirement that a medical physicist
who is qualified in mammography as described in subparagraph (E) survey mammography equipment and oversee quality assurance practices at each facility;

Page 386

(G) a requirement that—
(i) a facility that performs any mammogram—
(I) except as provided in subclause (II),
maintain the mammogram in the permanent medical records of the patient for a
period of not less than 5 years, or not
less than 10 years if no subsequent mammograms of such patient are performed
at the facility, or longer if mandated by
State law; and
(II) upon the request of or on behalf of
the patient, transfer the mammogram to
a medical institution, to a physician of
the patient, or to the patient directly;
and
(ii)(I) a facility must assure the preparation of a written report of the results of
any mammography examination signed by
the interpreting physician;
(II) such written report shall be provided
to the patient’s physicians (if any);
(III) if such a physician is not available
or if there is no such physician, the written report shall be sent directly to the patient; and
(IV) whether or not such a physician is
available or there is no such physician, a
summary of the written report shall be
sent directly to the patient in terms easily
understood by a lay person; and
(H) standards relating to special techniques for mammography of patients with
breast implants.
Subparagraph (G) shall not be construed to
limit a patient’s access to the patient’s medical records.
(2) Certification of personnel
The Secretary shall by regulation—
(A) specify organizations eligible to certify
individuals to perform radiological procedures as required by paragraph (1)(C);
(B) specify boards eligible to certify physicians to interpret radiological procedures,
including mammography, as required by
paragraph (1)(D);
(C) establish standards for a program to
certify physicians described in paragraph
(1)(D); and
(D) specify boards eligible to certify medical physicists who are qualified to survey
mammography equipment and to oversee
quality assurance practices at mammography facilities.
(g) Inspections
(1) Annual inspections
(A) In general
The Secretary may enter and inspect facilities to determine compliance with the
certification requirements under subsection
(b) of this section and the standards established under subsection (f) of this section.
The Secretary shall, if feasible, delegate to a
State or local agency the authority to make
such inspections.
(B) Identification
The Secretary, or State or local agency
acting on behalf of the Secretary, may con-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

duct inspections only on presenting identification to the owner, operator, or agent in
charge of the facility to be inspected.
(C) Scope of inspection
In conducting inspections, the Secretary
or State or local agency acting on behalf of
the Secretary—
(i) shall have access to all equipment,
materials, records, and information that
the Secretary or State or local agency
considers necessary to determine whether
the facility is being operated in accordance with this section; and
(ii) may copy, or require the facility to
submit to the Secretary or the State or
local agency, any of the materials,
records, or information.
(D) Qualifications of inspectors
Qualified individuals, as determined by the
Secretary, shall conduct all inspections. The
Secretary may request that a State or local
agency acting on behalf of the Secretary
designate a qualified officer or employee to
conduct the inspections, or designate a
qualified Federal officer or employee to conduct inspections. The Secretary shall establish minimum qualifications and appropriate
training for inspectors and criteria for certification of inspectors in order to inspect
facilities for compliance with subsection (f)
of this section.
(E) Frequency
The Secretary or State or local agency
acting on behalf of the Secretary shall conduct inspections under this paragraph of
each facility not less often than annually,
subject to paragraph (6).
(F) Records and annual reports
The Secretary or a State or local agency
acting on behalf of the Secretary which is
responsible for inspecting mammography facilities shall maintain records of annual inspections required under this paragraph for a
period as prescribed by the Secretary. Such
a State or local agency shall annually prepare and submit to the Secretary a report
concerning the inspections carried out under
this paragraph. Such reports shall include a
description of the facilities inspected and
the results of such inspections.
(2) Inspection of accredited facilities
The Secretary shall inspect annually a sufficient number of the facilities accredited by an
accreditation body to provide the Secretary
with a reasonable estimate of the performance
of such body.
(3) Inspection of facilities inspected by State or
local agencies
The Secretary shall inspect annually facilities inspected by State or local agencies acting on behalf of the Secretary to assure a reasonable performance by such State or local
agencies.
(4) Timing
The Secretary, or State or local agency,
may conduct inspections under paragraphs (1),

§ 263b

(2), and (3), during regular business hours or at
a mutually agreeable time and after providing
such notice as the Secretary may prescribe,
except that the Secretary may waive such requirements if the continued performance of
mammography at such facility threatens the
public health.
(5) Limited reinspection
Nothing in this section limits the authority
of the Secretary to conduct limited reinspections of facilities found not to be in compliance with this section.
(6) Demonstration program
(A) In general
The Secretary may establish a demonstration program under which inspections under
paragraph (1) of selected facilities are conducted less frequently by the Secretary (or
as applicable, by State or local agencies acting on behalf of the Secretary) than the interval specified in subparagraph (E) of such
paragraph.
(B) Requirements
Any demonstration program under subparagraph (A) shall be carried out in accordance with the following:
(i) The program may not be implemented
before April 1, 2001. Preparations for the
program may be carried out prior to such
date.
(ii) In carrying out the program, the Secretary may not select a facility for inclusion in the program unless the facility is
substantially free of incidents of noncompliance with the standards under subsection (f) of this section. The Secretary
may at any time provide that a facility
will no longer be included in the program.
(iii) The number of facilities selected for
inclusion in the program shall be sufficient to provide a statistically significant
sample, subject to compliance with clause
(ii).
(iv) Facilities that are selected for inclusion in the program shall be inspected at
such intervals as the Secretary determines
will reasonably ensure that the facilities
are maintaining compliance with such
standards.
(h) Sanctions
(1) In general
In order to promote voluntary compliance
with this section, the Secretary may, in lieu
of taking the actions authorized by subsection
(i) of this section, impose one or more of the
following sanctions:
(A) Directed plans of correction which afford a facility an opportunity to correct violations in a timely manner.
(B) Payment for the cost of onsite monitoring.
(2) Patient information
If the Secretary determines that the quality
of mammography performed by a facility
(whether or not certified pursuant to subsection (c) of this section) was so inconsistent
with the quality standards established pursu-

§ 263b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ant to subsection (f) of this section as to
present a significant risk to individual or public health, the Secretary may require such facility to notify patients who received mammograms at such facility, and their referring
physicians, of the deficiencies presenting such
risk, the potential harm resulting, appropriate
remedial measures, and such other relevant
information as the Secretary may require.
(3) Civil money penalties
The Secretary may assess civil money penalties in an amount not to exceed $10,000 for—
(A) failure to obtain a certificate as required by subsection (b) of this section,
(B) each failure by a facility to substantially comply with, or each day on which a
facility fails to substantially comply with,
the standards established under subsection
(f) of this section or the requirements described in subclauses (I) through (III) of subsection (d)(1)(B)(ii) of this section,
(C) each failure to notify a patient of risk
as required by the Secretary pursuant to
paragraph (2), and
(D) each violation, or for each aiding and
abetting in a violation of, any provision of,
or regulation promulgated under, this section by an owner, operator, or any employee
of a facility required to have a certificate.
(4) Procedures
The Secretary shall develop and implement
procedures with respect to when and how each
of the sanctions is to be imposed under paragraphs (1) through (3). Such procedures shall
provide for notice to the owner or operator of
the facility and a reasonable opportunity for
the owner or operator to respond to the proposed sanctions and appropriate procedures for
appealing determinations relating to the imposition of sanctions.
(i) Suspension and revocation
(1) In general
The certificate of a facility issued under subsection (c) of this section may be suspended or
revoked if the Secretary finds, after providing,
except as provided in paragraph (2), reasonable
notice and an opportunity for a hearing to the
owner or operator of the facility, that the
owner, operator, or any employee of the facility—
(A) has been guilty of misrepresentation in
obtaining the certificate;
(B) has failed to comply with the requirements of subsection (d)(1)(B)(ii)(III) of this
section or the standards established by the
Secretary under subsection (f) of this section;
(C) has failed to comply with reasonable
requests of the Secretary (or of an accreditation body approved pursuant to subsection
(e) of this section) for any record, information, report, or material that the Secretary
(or such accreditation body or State carrying out certification program requirements
pursuant to subsection (q) of this section)
concludes is necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the
standards established under subsection (f) of
this section;

Page 388

(D) has refused a reasonable request of the
Secretary, any Federal officer or employee
duly designated by the Secretary, or any
State or local officer or employee duly designated by the State or local agency, for permission to inspect the facility or the operations and pertinent records of the facility
in accordance with subsection (g) of this section;
(E) has violated or aided and abetted in
the violation of any provision of, or regulation promulgated under, this section; or
(F) has failed to comply with a sanction
imposed under subsection (h) of this section.
(2) Action before a hearing
(A) In general
The Secretary may suspend the certificate
of the facility before holding a hearing required by paragraph (1) if the Secretary has
reason to believe that the circumstance of
the case will support one or more of the findings described in paragraph (1) and that—
(i) the failure or violation was intentional; or
(ii) the failure or violation presents a serious risk to human health.
(B) Hearing
If the Secretary suspends a certificate
under subparagraph (A), the Secretary shall
provide an opportunity for a hearing to the
owner or operator of the facility not later
than 60 days from the effective date of the
suspension. The suspension shall remain in
effect until the decision of the Secretary
made after the hearing.
(3) Ineligibility to own or operate facilities
after revocation
If the Secretary revokes the certificate of a
facility on the basis of an act described in
paragraph (1), no person who owned or operated the facility at the time of the act may,
within 2 years of the revocation of the certificate, own or operate a facility that requires a
certificate under this section.
(j) Injunctions
If the Secretary determines that—
(1) continuation of any activity related to
the provision of mammography by a facility
would constitute a serious risk to human
health, the Secretary may bring suit in the
district court of the United States for the district in which the facility is situated to enjoin
continuation of the activity; and
(2) a facility is operating without a certificate as required by subsection (b) of this section, the Secretary may bring suit in the district court of the United States for the district
in which the facility is situated to enjoin the
operation of the facility.
Upon a proper showing, the district court shall
grant a temporary injunction or restraining
order against continuation of the activity or
against operation of a facility, as the case may
be, without requiring the Secretary to post a
bond, pending issuance of a final order under
this subsection.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(k) Judicial review
(1) Petition
If the Secretary imposes a sanction on a facility under subsection (h) of this section or
suspends or revokes the certificate of a facility under subsection (i) of this section, the
owner or operator of the facility may, not
later than 60 days after the date the action of
the Secretary becomes final, file a petition
with the United States court of appeals for the
circuit in which the facility is situated for judicial review of the action. As soon as practicable after receipt of the petition, the clerk
of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary. As soon as practicable after receipt of the copy, the Secretary
shall file in the court the record on which the
action of the Secretary is based, as provided in
section 2112 of title 28.
(2) Additional evidence
If the petitioner applies to the court for
leave to adduce additional evidence, and shows
to the satisfaction of the court that the additional evidence is material and that there
were reasonable grounds for the failure to adduce such evidence in the proceeding before
the Secretary, the court may order the additional evidence (and evidence in rebuttal of
the additional evidence) to be taken before the
Secretary, and to be adduced upon the hearing
in such manner and upon such terms and conditions as the court may determine to be proper. The Secretary may modify the findings of
the Secretary as to the facts, or make new
findings, by reason of the additional evidence
so taken, and the Secretary shall file the
modified or new findings, and the recommendations of the Secretary, if any, for the
modification or setting aside of the original
action of the Secretary with the return of the
additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in
paragraph (1), the court shall have jurisdiction
to affirm the action, or to set the action aside
in whole or in part, temporarily or permanently. The findings of the Secretary as to the
facts, if supported by substantial evidence,
shall be conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any action of
the Secretary shall be final, subject to review
by the Supreme Court of the United States
upon certiorari or certification, as provided in
section 1254 of title 28.
(l) Information
(1) In general
Not later than October 1, 1996, and annually
thereafter, the Secretary shall compile and
make available to physicians and the general
public information that the Secretary determines is useful in evaluating the performance
of facilities, including a list of facilities—
(A) that have been convicted under Federal or State laws relating to fraud and
abuse, false billings, or kickbacks;

§ 263b

(B) that have been subject to sanctions
under subsection (h) of this section, together
with a statement of the reasons for the sanctions;
(C) that have had certificates revoked or
suspended under subsection (i) of this section, together with a statement of the reasons for the revocation or suspension;
(D) against which the Secretary has taken
action under subsection (j) of this section,
together with a statement of the reasons for
the action;
(E) whose accreditation has been revoked,
together with a statement of the reasons of
the revocation;
(F) against which a State has taken adverse action; and
(G) that meets such other measures of performance as the Secretary may develop.
(2) Date
The information to be compiled under paragraph (1) shall be information for the calendar
year preceding the date the information is to
be made available to the public.
(3) Explanatory information
The information to be compiled under paragraph (1) shall be accompanied by such explanatory information as may be appropriate to
assist in the interpretation of the information
compiled under such paragraph.
(m) State laws
Nothing in this section shall be construed to
limit the authority of any State to enact and
enforce laws relating to the matters covered by
this section that are at least as stringent as this
section or the regulations issued under this section.
(n) National Advisory Committee
(1) Establishment
In carrying out this section, the Secretary
shall establish an advisory committee to be
known as the National Mammography Quality
Assurance Advisory Committee (hereafter in
this subsection referred to as the ‘‘Advisory
Committee’’).
(2) Composition
The Advisory Committee shall be composed
of not fewer than 13, nor more than 19 individuals, who are not officers or employees of the
Federal Government. The Secretary shall
make appointments to the Advisory Committee from among—
(A) physicians,
(B) practitioners, and
(C) other health professionals,
whose clinical practice, research specialization, or professional expertise include a significant focus on mammography. The Secretary shall appoint at least 4 individuals from
among national breast cancer or consumer
health organizations with expertise in mammography, at least 2 industry representatives
with expertise in mammography equipment,
and at least 2 practicing physicians who provide mammography services.
(3) Functions and duties
The Advisory Committee shall—

§ 263b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) advise the Secretary on appropriate
quality standards and regulations for mammography facilities;
(B) advise the Secretary on appropriate
standards and regulations for accreditation
bodies;
(C) advise the Secretary in the development of regulations with respect to sanctions;
(D) assist in developing procedures for
monitoring compliance with standards under
subsection (f) of this section;
(E) make recommendations and assist in
the establishment of a mechanism to investigate consumer complaints;
(F) report on new developments concerning breast imaging that should be considered
in the oversight of mammography facilities;
(G) determine whether there exists a
shortage of mammography facilities in rural
and health professional shortage areas and
determine the effects of personnel or other
requirements of subsection (f) of this section
on access to the services of such facilities in
such areas;
(H) determine whether there will exist a
sufficient number of medical physicists after
October 1, 1999, to assure compliance with
the requirements of subsection (f)(1)(E) of
this section;
(I) determine the costs and benefits of
compliance with the requirements of this
section (including the requirements of regulations promulgated under this section); and
(J) perform other activities that the Secretary may require.
The Advisory Committee shall report the findings made under subparagraphs (G) and (I) to
the Secretary and the Congress no later than
October 1, 1993.
(4) Meetings
The Advisory Committee shall meet not less
than quarterly for the first 3 years of the program and thereafter, at least annually.
(5) Chairperson
The Secretary shall appoint a chairperson of
the Advisory Committee.
(o) Consultations
In carrying out this section, the Secretary
shall consult with appropriate Federal agencies
within the Department of Health and Human
Services for the purposes of developing standards, regulations, evaluations, and procedures
for compliance and oversight.
(p) Breast cancer screening surveillance research grants
(1) Research
(A) Grants
The Secretary shall award grants to such
entities as the Secretary may determine to
be appropriate to establish surveillance systems in selected geographic areas to provide
data to evaluate the functioning and effectiveness of breast cancer screening programs
in the United States, including assessments
of participation rates in screening mammography, diagnostic procedures, incidence of

Page 390

breast cancer, mode of detection (mammography screening or other methods), outcome
and follow up information, and such related
epidemiologic analyses that may improve
early cancer detection and contribute to reduction in breast cancer mortality. Grants
may be awarded for further research on
breast cancer surveillance systems upon the
Secretary’s review of the evaluation of the
program.
(B) Use of funds
Grants awarded under subparagraph (A)
may be used—
(i) to study—
(I) methods to link mammography and
clinical breast examination records with
population-based cancer registry data;
(II) methods to provide diagnostic outcome data, or facilitate the communication of diagnostic outcome data, to radiology facilities for purposes of evaluating patterns of mammography interpretation; and
(III) mechanisms for limiting access
and maintaining confidentiality of all
stored data; and
(ii) to conduct pilot testing of the methods and mechanisms described in subclauses (I), (II), and (III) of clause (i) on a
limited basis.
(C) Grant application
To be eligible to receive funds under this
paragraph, an entity shall submit an application to the Secretary at such time, in such
manner, and containing such information as
the Secretary may require.
(D) Report
A recipient of a grant under this paragraph
shall submit a report to the Secretary containing the results of the study and testing
conducted under clauses (i) and (ii) of subparagraph (B), along with recommendations
for methods of establishing a breast cancer
screening surveillance system.
(2) Establishment
The Secretary shall establish a breast cancer screening surveillance system based on the
recommendations contained in the report described in paragraph (1)(D).
(3) Standards and procedures
The Secretary shall establish standards and
procedures for the operation of the breast cancer screening surveillance system, including
procedures to maintain confidentiality of patient records.
(4) Information
The Secretary shall recruit facilities to provide to the breast cancer screening surveillance system relevant data that could help in
the research of the causes, characteristics, and
prevalence of, and potential treatments for,
breast cancer and benign breast conditions, if
the information may be disclosed under section 552 of title 5.
(q) State program
(1) In general
The Secretary may, upon application, authorize a State—

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(A) to carry out, subject to paragraph (2),
the certification program requirements
under subsections (b), (c), (d), (g)(1), (h), (i),
and (j) of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) to implement the standards established
by the Secretary under subsection (f) of this
section,
with respect to mammography facilities operating within the State.
(2) Approval
The Secretary may approve an application
under paragraph (1) if the Secretary determines that—
(A) the State has enacted laws and issued
regulations relating to mammography facilities which are the requirements of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) the State has provided satisfactory assurances that the State—
(i) has the legal authority and qualified
personnel necessary to enforce the requirements of and the regulations promulgated
pursuant to this section (including the requirements under regulations promulgated
pursuant to such subsections),
(ii) will devote adequate funds to the administration and enforcement of such requirements, and
(iii) will provide the Secretary with such
information and reports as the Secretary
may require.
(3) Authority of Secretary
In a State with an approved application—
(A) the Secretary shall carry out the Secretary’s functions under subsections (e) and
(f) of this section;
(B) the Secretary may take action under
subsections (h), (i), and (j) of this section;
and
(C) the Secretary shall conduct oversight
functions under subsections (g)(2) and (g)(3)
of this section.
(4) Withdrawal of approval
(A) In general
The Secretary may, after providing notice
and opportunity for corrective action, withdraw the approval of a State’s authority
under paragraph (1) if the Secretary determines that the State does not meet the requirements of such paragraph. The Secretary shall promulgate regulations for the
implementation of this subparagraph.
(B) Effect of withdrawal
If the Secretary withdraws the approval of
a State under subparagraph (A), the certificate of any facility certified by the State
shall continue in effect until the expiration
of a reasonable period, as determined by the
Secretary, for such facility to obtain certification by the Secretary.
(r) Funding
(1) Fees
(A) In general
The Secretary shall, in accordance with
this paragraph assess and collect fees from

§ 263b

persons described in subsection (d)(1)(A) of
this section (other than persons who are governmental entities, as determined by the
Secretary) to cover the costs of inspections
conducted under subsection (g)(1) of this section by the Secretary or a State acting
under a delegation under subparagraph (A)
of such subsection. Fees may be assessed and
collected under this paragraph only in such
manner as would result in an aggregate
amount of fees collected during any fiscal
year which equals the aggregate amount of
costs for such fiscal year for inspections of
facilities of such persons under subsection
(g)(1) of this section. A person’s liability for
fees shall be reasonably based on the proportion of the inspection costs which relate to
such person.
(B) Deposit and appropriations
(i) Deposit and availability
Fees collected under subparagraph (A)
shall be deposited as an offsetting collection to the appropriations for the Department of Health and Human Services as
provided in appropriation Acts and shall
remain available without fiscal year limitation.
(ii) Appropriations
Fees collected under subparagraph (A)
shall be collected and available only to the
extent provided in advance in appropriation Acts.
(2) Authorization of appropriations
There are authorized to be appropriated to
carry out this section—
(A) to award research grants under subsection (p) of this section, such sums as may
be necessary for each of the fiscal years 1993
through 2007; and
(B) for the Secretary to carry out other activities which are not supported by fees authorized and collected under paragraph (1),
such sums as may be necessary for fiscal
years 1993 through 2007.
(July 1, 1944, ch. 373, title III, § 354, as added Pub.
L. 102–539, § 2, Oct. 27, 1992, 106 Stat. 3547; amended Pub. L. 105–248, §§ 2–13, Oct. 9, 1998, 112 Stat.
1864–1867; Pub. L. 108–365, §§ 2–4, Oct. 25, 2004, 118
Stat. 1738–1740.)
PRIOR PROVISIONS
A prior section 263b, act July 1, 1944, ch. 373, title III,
§ 354, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat.
1173; amended Nov. 28, 1990, Pub. L. 101–629, § 19(a)(1)(B),
104 Stat. 4529; Aug. 13, 1993, Pub. L. 103–80, § 4(a)(2), 107
Stat. 779, set forth Congressional declaration of purpose, prior to repeal by Pub. L. 101–629, § 19(a)(3), Nov.
28, 1990, 104 Stat. 4530.
Sections 263c to 263n, act July 1, 1944, ch. 373, title III,
§§ 355–360F, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3),
82 Stat. 1174, and amended, which related to electronic
product radiation control, were renumbered sections
531 to 542, respectively, of the Federal Food, Drug, and
Cosmetic Act by Pub. L. 101–629, § 19(a)(4), Nov. 28, 1990,
104 Stat. 4530, and are classified to sections 360hh to
360ss, respectively, of Title 21, Food and Drugs.
AMENDMENTS
2004—Subsec. (b)(1). Pub. L. 108–365, § 2(1)(C), substituted ‘‘temporary renewal certificate, provisional

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

certificate, or a limited provisional certificate’’ for
‘‘provisional certificate’’ in concluding provisions.
Subsec. (b)(1)(A). Pub. L. 108–365, § 2(1)(A), inserted
‘‘or a temporary renewal certificate’’ after ‘‘certificate’’ in introductory provisions and substituted ‘‘paragraphs (1) or (2) of subsection (c)’’ for ‘‘subsection
(c)(1)’’ in cl. (i).
Subsec. (b)(1)(B). Pub. L. 108–365, § 2(1)(B), inserted
‘‘or a limited provisional certificate’’ after ‘‘certificate’’ in introductory provisions and substituted ‘‘paragraphs (3) and (4) of subsection (c)’’ for ‘‘subsection
(c)(2)’’ in cl. (i).
Subsec. (c)(2) to (4). Pub. L. 108–365, § 2(2), added pars.
(2) and (3) and redesignated former par. (2) as (4).
Subsec. (n)(2). Pub. L. 108–365, § 3(1), reenacted subpar.
(C) without change, added concluding provisions, and
struck out former concluding provisions which read as
follows: ‘‘whose clinical practice, research specialization, or professional expertise include a significant
focus on mammography. The Secretary shall appoint at
least 4 individuals from among national breast cancer
or consumer health organizations with expertise in
mammography and at least 2 practicing physicians who
provide mammography services.’’
Subsec. (n)(4). Pub. L. 108–365, § 3(2), substituted ‘‘annually’’ for ‘‘biannually’’.
Subsec. (r)(2). Pub. L. 108–365, § 4, substituted ‘‘2007’’
for ‘‘2002’’ in subpars. (A) and (B).
1998—Subsec. (a)(4). Pub. L. 105–248, § 9(1), inserted ‘‘or
local’’ after ‘‘State’’.
Subsec. (a)(8). Pub. L. 105–248, § 4(b), added par. (8).
Subsec. (d)(2)(B). Pub. L. 105–248, § 3, substituted
‘‘part 498 of title 42, Code of Federal Regulations’’ for
‘‘42 C.F.R. 498 and in effect on October 27, 1992’’.
Subsec. (e)(1)(B)(i)(I), (II). Pub. L. 105–248, § 4(a)(1),
substituted ‘‘review physicians’’ for ‘‘practicing physicians’’.
Subsec. (e)(1)(B)(ii). Pub. L. 105–248, § 4(a)(2), substituted ‘‘relationship’’ for ‘‘financial relationship’’.
Subsec. (f)(1)(G)(i). Pub. L. 105–248, § 5, added cl. (i)
and struck out former cl. (i) which read as follows: ‘‘a
facility that performs any mammogram maintain the
mammogram in the permanent medical records of the
patient—
‘‘(I) for a period of not less than 5 years, or not less
than 10 years if no additional mammograms of such
patient are performed at the facility, or longer if
mandated by State law; or
‘‘(II) until such time as the patient should request
that the patient’s medical records be forwarded to a
medical institution or a physician of the patient;
whichever is longer; and’’.
Subsec. (f)(1)(G)(ii)(IV). Pub. L. 105–248, § 6, added
subcl. (IV) and struck out former subcl. (IV) which read
as follows: ‘‘if such report is sent to the patient, the report shall include a summary written in terms easily
understood by a lay person; and’’.
Subsec. (g)(1). Pub. L. 105–248, § 9(1), inserted ‘‘or
local’’ after ‘‘State’’ wherever appearing.
Subsec. (g)(1)(A). Pub. L. 105–248, § 7, in first sentence,
struck out ‘‘certified’’ before ‘‘facilities’’ and inserted
‘‘the certification requirements under subsection (b) of
this section and’’ after ‘‘compliance with’’.
Subsec. (g)(1)(E). Pub. L. 105–248, § 8(1), inserted
‘‘, subject to paragraph (6)’’ before period at end.
Subsec. (g)(3). Pub. L. 105–248, § 9(1), (2), inserted ‘‘or
local’’ after ‘‘State’’ in heading and in two places in
text.
Subsec. (g)(4). Pub. L. 105–248, § 9(1), inserted ‘‘or
local’’ after ‘‘State’’.
Subsec. (g)(6). Pub. L. 105–248, § 8(2), added par. (6).
Subsec. (h)(2). Pub. L. 105–248, § 10(a), added par. (2)
and redesignated former par. (2) as (3).
Subsec. (h)(3). Pub. L. 105–248, § 10(a)(1), (b), redesignated par. (2) as (3), added subpar. (C), and redesignated
former subpar. (C) as (D). Former par. (3) redesignated
(4).
Subsec. (h)(4). Pub. L. 105–248, § 10(a)(1), (c), redesignated par. (3) as (4) and substituted ‘‘paragraphs (1)
through (3)’’ for ‘‘paragraphs (1) and (2)’’.

Page 392

Subsec. (i)(1)(C). Pub. L. 105–248, § 11, inserted ‘‘(or of
an accreditation body approved pursuant to subsection
(e) of this section)’’ after ‘‘of the Secretary’’ and inserted ‘‘(or such accreditation body or State carrying
out certification program requirements pursuant to
subsection (q) of this section)’’ after ‘‘that the Secretary’’.
Subsec. (i)(1)(D). Pub. L. 105–248, § 9(3), inserted ‘‘or
local’’ after ‘‘any State’’ and ‘‘or local agency’’ after
‘‘by the State’’.
Subsec. (i)(2)(A). Pub. L. 105–248, § 12, substituted ‘‘has
reason to believe that the circumstance of the case will
support one or more of the findings described in paragraph (1) and that—’’ and cls. (i) and (ii) for ‘‘makes the
finding described in paragraph (1) and determines
that—
‘‘(i) the failure of a facility to comply with the
standards established by the Secretary under subsection (f) of this section presents a serious risk to
human health; or
‘‘(ii) a facility has engaged in an action described in
subparagraph (D) or (E) of paragraph (1).’’
Subsec. (q)(4)(B). Pub. L. 105–248, § 13, substituted
‘‘certified’’ for ‘‘accredited’’.
Subsec. (r)(2)(A). Pub. L. 105–248, § 2, substituted ‘‘subsection (p)’’ for ‘‘subsection (q)’’ and ‘‘2002’’ for ‘‘1997’’.
Subsec. (r)(2)(B). Pub. L. 105–248, § 2, substituted ‘‘fiscal years’’ for ‘‘fiscal year’’ and ‘‘2002’’ for ‘‘1997’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by Congress, its duration is
otherwise provided for by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REGULATIONS
Pub. L. 103–183, title VII, § 707, Dec. 14, 1993, 107 Stat.
2241, provided that: ‘‘The Secretary of Health and
Human Services is authorized to issue interim final
regulations—
‘‘(1) under which the Secretary may approve accreditation bodies under section 354(e) of the Public
Health Service Act (42 U.S.C. 263b(e)); and
‘‘(2) establishing quality standards under section
354(f) of the Public Health Service Act (42 U.S.C.
263b(f)).’’
STUDY
Section 3 of Pub. L. 102–539 directed Comptroller General of United States to conduct a study of the certifi-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

cation program authorized by this section to determine
if the program has resulted in improvement of quality
and accessibility of mammography services, and if the
program has reduced the frequency of poor quality
mammography and improved early detection of breast
cancer, with Comptroller General, not later than 3
years from Oct. 27, 1992, submit to Congress an interim
report of results of study and, not later than 5 years
from such date to submit a final report.

PART G—QUARANTINE AND INSPECTION
§ 264. Regulations to control communicable diseases
(a) Promulgation and enforcement by Surgeon
General
The Surgeon General, with the approval of the
Secretary, is authorized to make and enforce
such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases
from foreign countries into the States or possessions, or from one State or possession into any
other State or possession. For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection,
fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles
found to be so infected or contaminated as to be
sources of dangerous infection to human beings,
and other measures, as in his judgment may be
necessary.
(b) Apprehension, detention, or conditional release of individuals
Regulations prescribed under this section
shall not provide for the apprehension, detention, or conditional release of individuals except
for the purpose of preventing the introduction,
transmission, or spread of such communicable
diseases as may be specified from time to time
in Executive orders of the President upon the
recommendation of the Secretary, in consultation with the Surgeon General,1.
(c) Application of regulations to persons entering
from foreign countries
Except as provided in subsection (d) of this
section, regulations prescribed under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be applicable only to
individuals coming into a State or possession
from a foreign country or a possession.
(d) Apprehension and examination of persons
reasonably believed to be infected
(1) Regulations prescribed under this section
may provide for the apprehension and examination of any individual reasonably believed to be
infected with a communicable disease in a qualifying stage and (A) to be moving or about to
move from a State to another State; or (B) to be
a probable source of infection to individuals
who, while infected with such disease in a qualifying stage, will be moving from a State to another State. Such regulations may provide that
if upon examination any such individual is
found to be infected, he may be detained for
such time and in such manner as may be reason1 So

in original. Comma probably should not appear.

§ 264

ably necessary. For purposes of this subsection,
the term ‘‘State’’ includes, in addition to the
several States, only the District of Columbia.
(2) For purposes of this subsection, the term
‘‘qualifying stage’’, with respect to a communicable disease, means that such disease—
(A) is in a communicable stage; or
(B) is in a precommunicable stage, if the disease would be likely to cause a public health
emergency if transmitted to other individuals.
(e) Preemption
Nothing in this section or section 266 of this
title, or the regulations promulgated under such
sections, may be construed as superseding any
provision under State law (including regulations
and including provisions established by political
subdivisions of States), except to the extent
that such a provision conflicts with an exercise
of Federal authority under this section or section 266 of this title.
(July 1, 1944, ch. 373, title III, § 361, 58 Stat. 703;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Pub. L. 86–624, § 29(c), July
12, 1960, 74 Stat. 419; Pub. L. 94–317, title III,
§ 301(b)(1), June 23, 1976, 90 Stat. 707; Pub. L.
107–188, title I, § 142(a)(1), (2), (b)(1), (c), June 12,
2002, 116 Stat. 626, 627.)
AMENDMENTS
2002—Pub. L. 107–188, § 142(a)(1), (2), (b)(1), and (c),
which directed certain amendments to section 361 of
the Public Health Act, was executed by making the
amendments to this section, which is section 361 of the
Public Health Service Act, to reflect the probable intent of Congress. See below.
Subsec. (b). Pub. L. 107–188, § 142(a)(1), substituted
‘‘Executive orders of the President upon the recommendation of the Secretary, in consultation with the
Surgeon General,’’ for ‘‘Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General’’.
Subsec. (d). Pub. L. 107–188, § 142(a)(2), (b)(1), substituted in first sentence ‘‘Regulations’’ for ‘‘On recommendation of the National Advisory Health Council,
regulations’’, ‘‘in a qualifying stage’’ for ‘‘in a communicable stage’’ in two places, designated existing text
as par. (1) and substituted ‘‘(A)’’ and ‘‘(B)’’ for ‘‘(1)’’ and
‘‘(2)’’, respectively, and added par. (2).
Subsec. (e). Pub. L. 107–188, § 142(c), added subsec. (e).
1976—Subsec. (d). Pub. L. 94–317 inserted provision defining ‘‘State’’ to include, in addition to the several
States, only the District of Columbia.
1960—Subsec. (c). Pub. L. 86–624 struck out reference
to Territory of Hawaii.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86–624 effective Aug. 21, 1959,
see section 47(f) of Pub. L. 86–624, set out as a note
under section 201 of this title.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
EVALUATION OF PUBLIC HEALTH AUTHORITIES
Pub. L. 110–392, title I, § 121, Oct. 13, 2008, 122 Stat.
4200, provided that:
‘‘(a) IN GENERAL.—Not later than 180 days after the
date of enactment of the Comprehensive Tuberculosis
Elimination Act of 2008 [Oct. 13, 2008], the Secretary of
Health and Human Services shall prepare and submit to
the appropriate committees of Congress a report that
evaluates and provides recommendations on changes
needed to Federal and State public health authorities
to address current disease containment challenges such
as isolation and quarantine.
‘‘(b) CONTENTS OF EVALUATION.—The report described
in subsection (a) shall include—
‘‘(1) an evaluation of the effectiveness of current
policies to detain patients with active tuberculosis;
‘‘(2) an evaluation of whether Federal laws should
be strengthened to expressly address the movement
of individuals with active tuberculosis; and
‘‘(3) specific legislative recommendations for
changes to Federal laws, if any.
‘‘(c) UPDATE OF QUARANTINE REGULATIONS.—Not later
than 240 days after the date of enactment of this Act
[Oct. 13, 2008], the Secretary of Health and Human
Services shall promulgate regulations to update the
current interstate and foreign quarantine regulations
found in parts 70 and 71 of title 42, Code of Federal Regulations.’’
EXECUTIVE ORDER NO. 12452
Ex. Ord. No. 12452, Dec. 22, 1983, 48 F.R. 56927, which
specified certain communicable diseases for regulations
providing for the apprehension, detention, or conditional release of individuals to prevent the introduction, transmission, or spread of such diseases, was revoked by Ex. Ord. No. 13295, § 5, Apr. 4, 2003, 68 F.R.
17255, set out below.
EX. ORD. NO. 13295. REVISED LIST OF QUARANTINABLE
COMMUNICABLE DISEASES
Ex. Ord. No. 13295, Apr. 4, 2003, 68 F.R. 17255, as
amended by Ex. Ord. No. 13375, § 1, Apr. 1, 2005, 70 F.R.
17299, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, including section 361(b) of the Public Health
Service Act (42 U.S.C. 264(b)), it is hereby ordered as
follows:
SECTION 1. Based upon the recommendation of the
Secretary of Health and Human Services (the ‘‘Secretary’’), in consultation with the Surgeon General,
and for the purpose of specifying certain communicable
diseases for regulations providing for the apprehension,
detention, or conditional release of individuals to prevent the introduction, transmission, or spread of suspected communicable diseases, the following communicable diseases are hereby specified pursuant to section 361(b) of the Public Health Service Act:
(a) Cholera; Diphtheria; infectious Tuberculosis;
Plague; Smallpox; Yellow Fever; and Viral Hemorrhagic Fevers (Lassa, Marburg, Ebola, Crimean-Congo,
South American, and others not yet isolated or named).
(b) Severe Acute Respiratory Syndrome (SARS),
which is a disease associated with fever and signs and
symptoms of pneumonia or other respiratory illness, is
transmitted from person to person predominantly by
the aerosolized or droplet route, and, if spread in the
population, would have severe public health consequences.
(c) Influenza caused by novel or reemergent influenza
viruses that are causing, or have the potential to cause,
a pandemic.

Page 394

SEC. 2. The Secretary, in the Secretary’s discretion,
shall determine whether a particular condition constitutes a communicable disease of the type specified in
section 1 of this order.
SEC. 3. The functions of the President under sections
362 and 364(a) of the Public Health Service Act (42
U.S.C. 265 and 267(a)) are assigned to the Secretary.
SEC. 4. This order is not intended to, and does not,
create any right or benefit enforceable at law or equity
by any party against the United States, its departments, agencies, entities, officers, employees or agents,
or any other person.
SEC. 5. Executive Order 12452 of December 22, 1983, is
hereby revoked.
GEORGE W. BUSH.

§ 265. Suspension of entries and imports from
designated places to prevent spread of communicable diseases
Whenever the Surgeon General determines
that by reason of the existence of any communicable disease in a foreign country there is serious danger of the introduction of such disease
into the United States, and that this danger is
so increased by the introduction of persons or
property from such country that a suspension of
the right to introduce such persons and property
is required in the interest of the public health,
the Surgeon General, in accordance with regulations approved by the President, shall have the
power to prohibit, in whole or in part, the introduction of persons and property from such countries or places as he shall designate in order to
avert such danger, and for such period of time as
he may deem necessary for such purpose.
(July 1, 1944, ch. 373, title III, § 362, 58 Stat. 704.)
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
DELEGATION OF FUNCTIONS
For assignment of functions of President under this
section, see section 3 of Ex. Ord. No. 13295, Apr. 4, 2003,
68 F.R. 17255, set out as a note under section 264 of this
title.

§ 266. Special quarantine powers in time of war
To protect the military and naval forces and
war workers of the United States, in time of
war, against any communicable disease specified
in Executive orders as provided in subsection (b)
of section 264 of this title, the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the apprehension and examination, in time of war, of any individual reasonably believed (1) to be infected
with such disease and (2) to be a probable source
of infection to members of the armed forces of
the United States or to individuals engaged in
the production or transportation of arms, munitions, ships, food, clothing, or other supplies for
the armed forces. Such regulations may provide
that if upon examination any such individual is
found to be so infected, he may be detained for
such time and in such manner as may be reasonably necessary.

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(July 1, 1944, ch. 373, title III, § 363, 58 Stat. 704;
Pub. L. 107–188, title I, § 142(a)(3), (b)(2), June 12,
2002, 116 Stat. 626, 627.)
AMENDMENTS
2002—Pub. L. 107–188, which directed substitution of
‘‘the Secretary, in consultation with the Surgeon General,’’ for ‘‘the Surgeon General, on recommendation of
the National Advisory Health Council,’’ and striking
out of ‘‘in a communicable stage’’ after ‘‘(1) to be infected with such disease’’, in section 363 of the Public
Health Act, was executed to this section, which is section 363 of the Public Health Service Act, to reflect the
probable intent of Congress.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
TERMINATION OF WAR AND EMERGENCIES
Joint Res. July 25, 1947, ch. 327, § 3, 61 Stat. 451, provided that in the interpretation of this section, the
date July 25, 1947, shall be deemed to be the date of termination of any state of war theretofore declared by
Congress and of the national emergencies proclaimed
by the President on Sept. 8, 1939, and May 27, 1941.

§ 267. Quarantine stations, grounds, and anchorages
(a) Control and management
Except as provided in title II of the Act of
June 15, 1917, as amended [50 U.S.C. 191 et seq.],
the Surgeon General shall control, direct, and
manage all United States quarantine stations,
grounds, and anchorages, designate their boundaries, and designate the quarantine officers to
be in charge thereof. With the approval of the
President he shall from time to time select suitable sites for and establish such additional stations, grounds, and anchorages in the States and
possessions of the United States as in his judgment are necessary to prevent the introduction
of communicable diseases into the States and
possessions of the United States.
(b) Hours of inspection
The Surgeon General shall establish the hours
during which quarantine service shall be performed at each quarantine station, and, upon
application by any interested party, may establish quarantine inspection during the twentyfour hours of the day, or any fraction thereof, at
such quarantine stations as, in his opinion, require such extended service. He may restrict the
performance of quarantine inspection to hours
of daylight for such arriving vessels as cannot,
in his opinion, be satisfactorily inspected during
hours of darkness. No vessel shall be required to
undergo quarantine inspection during the hours
of darkness, unless the quarantine officer at
such quarantine station shall deem an immediate inspection necessary to protect the public
health. Uniformity shall not be required in the
hours during which quarantine inspection may
be obtained at the various ports of the United
States.

§ 267

(c) Overtime pay for employees of Service
The Surgeon General shall fix a reasonable
rate of extra compensation for overtime services
of employees of the United States Public Health
Service, Foreign Quarantine Division, performing overtime duties including the operation of
vessels, in connection with the inspection or
quarantine treatment of persons (passengers and
crews), conveyances, or goods arriving by land,
water, or air in the United States or any place
subject to the jurisdiction thereof, hereinafter
referred to as ‘‘employees of the Public Health
Service’’, when required to be on duty between
the hours of 6 o’clock postmeridian and 6 o’clock
antemeridian (or between the hours of 7 o’clock
postmeridian and 7 o’clock antemeridian at stations which have a declared workday of from 7
o’clock antemeridian to 7 o’clock postmeridian),
or on Sundays or holidays, such rate, in lieu of
compensation under any other provision of law,
to be fixed at two times the basic hourly rate for
each hour that the overtime extends beyond 6
o’clock (or 7 o’clock as the case may be) postmeridian, and two times the basic hourly rate
for each overtime hour worked on Sundays or
holidays. As used in this subsection, the term
‘‘basic hourly rate’’ shall mean the regular basic
rate of pay which is applicable to such employees for work performed within their regular
scheduled tour of duty.
(d) Payment of extra compensation to United
States; bond or deposit to assure payment;
deposit of moneys to credit of appropriation
(1) The said extra compensation shall be paid
to the United States by the owner, agent, consignee, operator, or master or other person in
charge of any conveyance, for whom, at his request, services as described in this subsection
(hereinafter referred to as overtime service) are
performed. If such employees have been ordered
to report for duty and have so reported, and the
requested services are not performed by reason
of circumstances beyond the control of the employees concerned, such extra compensation
shall be paid on the same basis as though the
overtime services had actually been performed
during the period between the time the employees were ordered to report for duty and did so report, and the time they were notified that their
services would not be required, and in any case
as though their services had continued for not
less than one hour. The Surgeon General with
the approval of the Secretary of Health and
Human Services may prescribe regulations requiring the owner, agent, consignee, operator, or
master or other person for whom the overtime
services are performed to file a bond in such
amounts and containing such conditions and
with such sureties, or in lieu of a bond, to deposit money or obligations of the United States
in such amount, as will assure the payment of
charges under this subsection, which bond or deposit may cover one or more transactions or all
transactions during a specified period: Provided,
That no charges shall be made for services performed in connection with the inspection of (1)
persons arriving by international highways, ferries, bridges, or tunnels, or the conveyances in
which they arrive, or (2) persons arriving by aircraft or railroad trains, the operations of which

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons arriving by vessels operated between Canadian ports and ports on Puget Sound or operated
on the Great Lakes and connecting waterways,
the operations of which are covered by published
schedules, or the vessels in which they arrive.
(2) Moneys collected under this subsection
shall be deposited in the Treasury of the United
States to the credit of the appropriation charged
with the expense of the services, and the appropriations so credited shall be available for the
payment of such compensation to the said employees for services so rendered.
(July 1, 1944, ch. 373, title III, § 364, 58 Stat. 704;
Pub. L. 85–58, ch. VII, § 701, June 21, 1957, 71 Stat.
181; Pub. L. 85–580, title II, § 201, Aug. 1, 1958, 72
Stat. 467; Pub. L. 96–88, title V, § 509(b), Oct. 17,
1979, 93 Stat. 695.)
AMENDMENTS
1958—Subsec. (c). Pub. L. 85–580 increased rate of pay
for each hour that overtime extends beyond 6 o’clock
(or 7 o’clock as the case may be) postmeridian from one
and one-half times the basic hourly rate to two times
the basic hourly rate.
1957—Subsecs. (c), (d). Pub. L. 85–58 added subsecs. (c)
and (d).
TRANSFER OF FUNCTIONS
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (d) pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.
DELEGATION OF FUNCTIONS
Functions of President delegated to Secretary of
Health Health and Human Services, see Ex. Ord. No.
11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as
a note under section 202 of this title.
For assignment of functions of President under subsec. (a) of this section, see section 3 of Ex. Ord. No.
13295, Apr. 4, 2003, 68 F.R. 17255, set out as a note under
section 264 of this title.

§ 268. Quarantine duties of consular and other officers
(a) Any consular or medical officer of the
United States, designated for such purpose by
the Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon General may prescribe, of
the health conditions at the port or place at
which such officer is stationed.
(b) It shall be the duty of the customs officers
and of Coast Guard officers to aid in the enforcement of quarantine rules and regulations; but no
additional compensation, except actual and necessary traveling expenses, shall be allowed any
such officer by reason of such services.
(July 1, 1944, ch. 373, title III, § 365, 58 Stat. 705;
1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631.)

Page 396

TRANSFER OF FUNCTIONS
For transfer of authorities, functions, personnel, and
assets of the Coast Guard, including the authorities
and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security,
and for treatment of related references, see sections
468(b), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Reference to Secretary of Health, Education, and
Welfare substituted for reference to Federal Security
Administrator pursuant to section 5 of Reorg. Plan No.
1, of 1953, set out as a note under section 3501 of this
title, which transferred functions of Federal Security
Administrator to Secretary of Health, Education, and
Welfare and all agencies of Federal Security Agency to
Department of Health, Education, and Welfare. Federal
Security Agency and office of Administrator abolished
by section 8 of Reorg. Plan No. 1 of 1953. Secretary and
Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human
Services by section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20.

§ 269. Bills of health
(a) Detail of medical officer; conditions precedent to issuance; consular officer to receive
fees
Except as otherwise prescribed in regulations,
any vessel at any foreign port or place clearing
or departing for any port or place in a State or
possession shall be required to obtain from the
consular officer of the United States or from the
Public Health Service officer, or other medical
officer of the United States designated by the
Surgeon General, at the port or place of departure, a bill of health in duplicate, in the form
prescribed by the Surgeon General. The President, from time to time, shall specify the ports
at which a medical officer shall be stationed for
this purpose. Such bill of health shall set forth
the sanitary history and condition of said vessel, and shall state that it has in all respects
complied with the regulations prescribed pursuant to subsection (c) of this section. Before
granting such duplicate bill of health, such consular or medical officer shall be satisfied that
the matters and things therein stated are true.
The consular officer shall be entitled to demand
and receive the fees for bills of health and such
fees shall be established by regulation.
(b) Collectors of customs to receive originals; duplicate copies as part of ship’s papers
Original bills of health shall be delivered to
the collectors of customs at the port of entry.
Duplicate copies of such bills of health shall be
delivered at the time of inspection to quarantine
officers at such port. The bills of health herein
prescribed shall be considered as part of the
ship’s papers, and when duly certified to by the
proper consular or other officer of the United
States, over his official signature and seal, shall
be accepted as evidence of the statements therein contained in any court of the United States.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Regulations to secure sanitary conditions of
vessels
The Surgeon General shall from time to time
prescribe regulations, applicable to vessels referred to in subsection (a) of this section for the
purpose of preventing the introduction into the
States or possessions of the United States of any
communicable disease by securing the best sanitary condition of such vessels, their cargoes,
passengers, and crews. Such regulations shall be
observed by such vessels prior to departure, during the course of the voyage, and also during inspection, disinfection, or other quarantine procedure upon arrival at any United States quarantine station.
(d) Vessels from ports near frontier
The provisions of subsections (a) and (b) of
this section shall not apply to vessels plying between such foreign ports on or near the frontiers
of the United States and ports of the United
States as are designated by treaty.
(e) Compliance with regulations
It shall be unlawful for any vessel to enter any
port in any State or possession of the United
States to discharge its cargo, or land its passengers, except upon a certificate of the quarantine officer that regulations prescribed under
subsection (c) of this section have in all respects
been complied with by such officer, the vessel,
and its master. The master of every such vessel
shall deliver such certificate to the collector of
customs at the port of entry, together with the
original bill of health and other papers of the
vessel. The certificate required by this subsection shall be procurable from the quarantine
officer, upon arrival of the vessel at the quarantine station and satisfactory inspection thereof, at any time within which quarantine services
are performed at such station.
(July 1, 1944, ch. 373, title III, § 366, 58 Stat. 705.)
TRANSFER OF FUNCTIONS
Functions of Public Health Service, Surgeon General
of Public Health Service, and all other officers and employees of Public Health Service, and functions of all
agencies of or in Public Health Service transferred to
Secretary of Health, Education, and Welfare by Reorg.
Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat.
1610, set out as a note under section 202 of this title.
Secretary of Health, Education, and Welfare redesignated Secretary of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.
All offices of collector of customs, comptroller of customs, surveyor of customs, and appraiser of merchandise of Bureau of Customs of Department of the Treasury to which appointments were required to be made by
the President with the advice and consent of the Senate ordered abolished, with such offices to be terminated not later than December 31, 1966, by Reorg. Plan
No. 1, of 1965, eff. May 25, 1965, 30 F.R. 7035, 79 Stat. 1317,
set out in the Appendix to Title 5, Government Organization and Employees. All functions of offices eliminated were already vested in Secretary of the Treasury
by Reorg. Plan No. 26 of 1950, eff. July 31, 1950, 15 F.R.
4935, 64 Stat. 1280, set out in the Appendix to Title 5.

§ 271

tion and aircraft of any of the provisions of sections 267 to 269 of this title and regulations prescribed thereunder (including penalties and forfeitures for violations of such sections and regulations), to such extent and upon such conditions as he deems necessary for the safeguarding
of the public health.
(July 1, 1944, ch. 373, title III, § 367, 58 Stat. 706.)
ABOLITION OF OFFICE OF SURGEON GENERAL
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 271. Penalties for violation of quarantine laws
(a) Penalties for persons violating quarantine
laws
Any person who violates any regulation prescribed under sections 264 to 266 of this title, or
any provision of section 269 of this title or any
regulation prescribed thereunder, or who enters
or departs from the limits of any quarantine
station, ground, or anchorage in disregard of
quarantine rules and regulations or without permission of the quarantine officer in charge, shall
be punished by a fine of not more than $1,000 or
by imprisonment for not more than one year, or
both.
(b) Penalties for vessels violating quarantine
laws
Any vessel which violates section 269 of this
title, or any regulations thereunder or under
section 267 of this title, or which enters within
or departs from the limits of any quarantine
station, ground, or anchorage in disregard of the
quarantine rules and regulations or without permission of the officer in charge, shall forfeit to
the United States not more than $5,000, the
amount to be determined by the court, which
shall be a lien on such vessel, to be recovered by
proceedings in the proper district court of the
United States. In all such proceedings the
United States attorney shall appear on behalf of
the United States; and all such proceedings shall
be conducted in accordance with the rules and
laws governing cases of seizure of vessels for violation of the revenue laws of the United States.
(c) Remittance or mitigation of forfeitures
With the approval of the Secretary, the Surgeon General may, upon application therefor,
remit or mitigate any forfeiture provided for
under subsection (b) of this section, and he shall
have authority to ascertain the facts upon all
such applications.
(July 1, 1944, ch. 373, title III, § 368, 58 Stat. 706;
June 25, 1948, ch. 646, § 1, 62 Stat. 909; 1953 Reorg.
Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631.)

§ 270. Quarantine regulations governing civil air
navigation and civil aircraft

CHANGE OF NAME

The Surgeon General is authorized to provide
by regulations for the application to air naviga-

Act June 25, 1948, eff. Sept. 1, 1948, substituted
‘‘United States attorney’’ for ‘‘United States district
attorney’’. See section 541 of Title 28, Judiciary and Ju-

§ 272

TITLE 42—THE PUBLIC HEALTH AND WELFARE

dicial Procedure, and Historical and Revision note
thereunder.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out as a note
under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of
Reorg. Plan No. 1 of 1953. Secretary and Department of
Health, Education, and Welfare redesignated Secretary
and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20.

§ 272. Administration of oaths by quarantine officers
Medical officers of the United States, when
performing duties as quarantine officers at any
port or place within the United States, are authorized to take declarations and administer
oaths in matters pertaining to the administration of the quarantine laws and regulations of
the United States.
(July 1, 1944, ch. 373, title III, § 369, 58 Stat. 706.)
PART H—ORGAN TRANSPLANTS
PRIOR PROVISIONS
A prior part H related to grants to Alaska for mental
health, prior to the general revision of part H by Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2342.
Another prior part H, entitled ‘‘National Library of
Medicine’’, as added by act Aug. 3, 1956, ch. 907, 70 Stat.
960, was redesignated part I and classified to section 275
et seq. of this title, prior to repeal by Pub. L. 99–158.

§ 273. Organ procurement organizations
(a) Grant authority of Secretary
(1) The Secretary may make grants for the
planning of qualified organ procurement organizations described in subsection (b) of this section.
(2) The Secretary may make grants for the establishment, initial operation, consolidation,
and expansion of qualified organ procurement
organizations described in subsection (b) of this
section.
(b) Qualified organizations
(1) A qualified organ procurement organization for which grants may be made under subsection (a) of this section is an organization
which, as determined by the Secretary, will
carry out the functions described in paragraph
(2) 1 and—
(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as specified by the Secretary) necessary
to assure the fiscal stability of the organization,

(C) has an agreement with the Secretary to
be reimbursed under title XVIII of the Social
Security Act [42 U.S.C. 1395 et seq.] for the
procurement of kidneys,
(D) notwithstanding any other provision of
law, has met the other requirements of this
section and has been certified or recertified by
the Secretary within the previous 4-year period as meeting the performance standards to
be a qualified organ procurement organization
through a process that either—
(i) granted certification or recertification
within such 4-year period with such certification or recertification in effect as of January 1, 2000, and remaining in effect through
the earlier of—
(I) January 1, 2002; or
(II) the completion of recertification
under the requirements of clause (ii); or
(ii) is defined through regulations that are
promulgated by the Secretary by not later
than January 1, 2002, that—
(I) require recertifications of qualified
organ procurement organizations not more
frequently than once every 4 years;
(II) rely on outcome and process performance measures that are based on empirical evidence, obtained through reasonable efforts, of organ donor potential and
other related factors in each service area
of qualified organ procurement organizations;
(III) use multiple outcome measures as
part of the certification process; and
(IV) provide for a qualified organ procurement organization to appeal a decertification to the Secretary on substantive
and procedural grounds; 2
(E) has procedures to obtain payment for
non-renal organs provided to transplant centers,
(F) has a defined service area that is of sufficient size to assure maximum effectiveness in
the procurement and equitable distribution of
organs, and that either includes an entire metropolitan statistical area (as specified by the
Director of the Office of Management and
Budget) or does not include any part of the
area,
(G) has a director and such other staff, including the organ donation coordinators and
organ procurement specialists necessary to effectively obtain organs from donors in its
service area, and
(H) has a board of directors or an advisory
board which—
(i) is composed of—
(I) members who represent hospital administrators, intensive care or emergency
room personnel, tissue banks, and voluntary health associations in its service
area,
(II) members who represent the public
residing in such area,
(III) a physician with knowledge, experience,
or
skill
in
the
field
of
histocompatability 3 or an individual with
2 So

1 See

References in Text note below.

Page 398

3 So

in original. The semicolon probably should be a comma.
in original. Probably should be ‘‘histocompatibility’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

a doctorate degree in a biological science
with knowledge, experience, or skill in the
field of histocompatibility,
(IV) a physician with knowledge or skill
in the field of neurology, and
(V) from each transplant center in its
service area which has arrangements described in paragraph (2)(G) 1 with the organization, a member who is a surgeon who
has practicing privileges in such center
and who performs organ transplant surgery,
(ii) has the authority to recommend policies for the procurement of organs and the
other functions described in paragraph (2),1
and
(iii) has no authority over any other activity of the organization.
(2)(A) Not later than 90 days after November
16, 1990, the Secretary shall publish in the Federal Register a notice of proposed rulemaking to
establish criteria for determining whether an
entity meets the requirement established in
paragraph (1)(E).1
(B) Not later than 1 year after November 16,
1990, the Secretary shall publish in the Federal
Register a final rule to establish the criteria described in subparagraph (A).
(3) An organ procurement organization shall—
(A) have effective agreements, to identify
potential organ donors, with a substantial majority of the hospitals and other health care
entities in its service area which have facilities for organ donations,
(B) conduct and participate in systematic efforts, including professional education, to acquire all useable organs from potential donors,
(C) arrange for the acquisition and preservation of donated organs and provide quality
standards for the acquisition of organs which
are consistent with the standards adopted by
the Organ Procurement and Transplantation
Network under section 274(b)(2)(E) of this
title, including arranging for testing with respect to preventing the acquisition of organs
that are infected with the etiologic agent for
acquired immune deficiency syndrome,
(D) arrange for the appropriate tissue typing
of donated organs,
(E) have a system to allocate donated organs
equitably among transplant patients according to established medical criteria,
(F) provide or arrange for the transportation
of donated organs to transplant centers,
(G) have arrangements to coordinate its activities with transplant centers in its service
area,
(H) participate in the Organ Procurement
Transplantation Network established under
section 274 of this title,
(I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as
may be appropriate to assure that all useable
tissues are obtained from potential donors,
(J) evaluate annually the effectiveness of
the organization in acquiring potentially
available organs, and
(K) assist hospitals in establishing and implementing protocols for making routine in-

§ 273

quiries about organ donations by potential donors.
(c) Pancreata islet cell transplantation or research
Pancreata procured by an organ procurement
organization and used for islet cell transplantation or research shall be counted for purposes
of certification or recertification under subsection (b) of this section.
(July 1, 1944, ch. 373, title III, § 371, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2342;
amended Pub. L. 100–607, title IV, § 402(a), (c)(1),
(2), (d), Nov. 4, 1988, 102 Stat. 3114, 3115; Pub. L.
101–616, title II, §§ 201(a)–(c)(1), (d), (e), 206(b),
Nov. 16, 1990, 104 Stat. 3283, 3285; Pub. L. 106–505,
title VII, § 701(c), Nov. 13, 2000, 114 Stat. 2347;
Pub. L. 106–554, § 1(a)(1) [title II, § 219(b)], Dec. 21,
2000, 114 Stat. 2763, 2763A–29; Pub. L. 108–216, § 9,
Apr. 5, 2004, 118 Stat. 590; Pub. L. 108–362, § 2, Oct.
25, 2004, 118 Stat. 1703.)
REFERENCES IN TEXT
Paragraph (2), referred to in subsec. (b)(1), meaning
paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of Pub. L.
101–616. See 1990 Amendment note below.
The Social Security Act, referred to in subsec.
(b)(1)(C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XVIII of the Social Security Act is classified generally to subchapter XVIII (§ 1395 et seq.) of
chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
Paragraph (1)(E), referred to in subsec. (b)(2)(A),
meaning paragraph (1)(E) of subsec. (b) of this section,
was redesignated paragraph (1)(F) by section 701(c)(1) of
Pub. L. 106–505 and section 1(a)(1) [title II, § 219(b)(1)] of
Pub. L. 106–554. See 2000 Amendment note below.
PRIOR PROVISIONS
A prior section 273, act July 1, 1944, ch. 373, title III,
§ 371, as added July 28, 1956, ch. 772, title II, § 201, 70
Stat. 709, authorized grants to the Territory of Alaska
for an integrated mental health program, prior to repeal by Pub. L. 86–70, § 31(b)(1), June 25, 1959, 73 Stat.
148, effective July 1, 1959.
A prior section 371 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 907, § 1, 70 Stat. 960, was renumbered
section 381 and classified to section 275 of this title,
prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99
Stat. 879.
AMENDMENTS
2004—Subsec. (a)(3). Pub. L. 108–216 struck out par. (3)
which read as follows: ‘‘The Secretary may make
grants to, and enter into contracts with, qualified
organ procurement organizations described in subsection (b) of this section and other nonprofit private
entities for the purpose of carrying out special projects
designed to increase the number of organ donors.’’
Subsec. (c). Pub. L. 108–362 added subsec. (c).
2000—Subsec. (b)(1)(D) to (H). Pub. L. 106–505 and Pub.
L. 106–554 amended par. (1) identically, adding subpar.
(D), redesignating former subpars. (D) to (G) as (E) to
(H), respectively, and realigning margins of subpar. (F).
1990—Pub. L. 101–616, § 201(a), substituted ‘‘Organ procurement organizations’’ for ‘‘Assistance for organ procurement organizations’’ in section catchline.
Subsec. (a)(3). Pub. L. 101–616, § 201(b)(1), substituted
‘‘may make grants to, and enter into contracts with,
qualified organ procurement organizations described in
subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special
projects’’ for ‘‘may make grants for special projects’’.
Subsec. (a)(4). Pub. L. 101–616, § 201(b)(2), struck out
par. (4) which set forth factors to consider in making
grants.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (b)(1)(E). Pub. L. 101–616, § 201(c)(1), amended
subpar. (E) generally. Prior to amendment, subpar. (E)
read as follows: ‘‘has a defined service area which is a
geographical area of sufficient size such that (unless
the service area comprises an entire State) the organization can reasonably expect to procure organs from
not less than 50 donors each year and which either includes an entire standard metropolitan statistical area
(as specified by the Office of Management and Budget)
or does not include any part of such an area,’’.
Subsec. (b)(1)(G)(i)(III). Pub. L. 101–616, § 201(e), made
technical correction to Pub. L. 100–607, § 402(c)(2). See
1988 Amendment note below.
Subsec. (b)(2), (3). Pub. L. 101–616, § 201(d), added par.
(2) and redesignated former par. (2) as (3).
Subsec. (c). Pub. L. 101–616, § 206(b), struck out subsec.
(c) which authorized appropriations for subsec. (a)
grants for fiscal years 1988 through 1990.
1988—Subsec. (a)(2). Pub. L. 100–607, § 402(a)(1), inserted ‘‘consolidation,’’ after ‘‘initial operation,’’.
Subsec. (a)(3). Pub. L. 100–607, § 402(a)(2), added par.
(3). Former par. (3) redesignated (4).
Subsec. (a)(4). Pub. L. 100–607, § 402(a)(2), redesignated
former par. (3) as (4).
Subsec. (a)(4)(C). Pub. L. 100–607, § 402(a)(3), added subpar. (C).
Subsec. (b)(1)(E). Pub. L. 100–607, § 402(c)(1)(A), substituted ‘‘size such that’’ for ‘‘size which’’, and ‘‘the organization can reasonably expect to procure organs
from not less than 50 donors each year’’ for ‘‘will include at least fifty potential organ donors each year’’.
Subsec. (b)(1)(G)(i)(III). Pub. L. 100–607, § 402(c)(2), as
amended by Pub. L. 101–616, § 201(e), inserted ‘‘or an individual with a doctorate degree in a biological science
with knowledge, experience, or skill in the field of
histocompatibility’’ before comma at end.
Subsec. (b)(2)(C). Pub. L. 100–607, § 402(c)(1)(B), substituted ‘‘274(b)(2)(E) of this title, including arranging
for testing with respect to preventing the acquisition of
organs that are infected with the etiologic agent for acquired immune deficiency syndrome,’’ for ‘‘274(b)(2)(D)
of this title,’’.
Subsec. (b)(2)(E). Pub. L. 100–607, § 402(c)(1)(C), substituted ‘‘organs equitably among transplant patients’’
for ‘‘organs among transplant centers and patients’’.
Subsec. (b)(2)(K). Pub. L. 100–607, § 402(c)(1)(D), added
subpar. (K).
Subsec. (c). Pub. L. 100–607, § 402(d), amended subsec.
(c) generally. Prior to amendment, subsec. (c) read as
follows: ‘‘For grants under subsection (a) of this section
there are authorized to be appropriated $5,000,000 for
fiscal year 1985, $8,000,000 for fiscal year 1986, and
$12,000,000 for fiscal year 1987.’’
EFFECTIVE DATE OF 1990 AMENDMENT
Section 207 of title II of Pub. L. 101–616 provided that:
‘‘Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and
274g of this title, amending this section and sections 274
and 274b to 274d of this title, and repealing provisions
set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act
[Nov. 16, 1990], whichever occurs later.’’
EFFECTIVE DATE OF 1988 AMENDMENT
Section 402(c)(3) of Pub. L. 100–607, as amended by
Pub. L. 101–274, Apr. 23, 1990, 104 Stat. 139, which provided that the amendment made by section 402(c)(1)(A)
of Pub. L. 100–607, amending this section, was not to
apply to an organ procurement organization designated
under section 1320b–8(b) of this title until Jan. 1, 1992,
was repealed by Pub. L. 101–616, title II, § 201(c)(2), Nov.
16, 1990, 104 Stat. 3283.
SHORT TITLE
For short title of Pub. L. 98–507, which enacted this
part as the ‘‘National Organ Transplant Act’’, see section 1 of Pub. L. 98–507, set out as a Short Title of 1984
Amendments note under section 201 of this title.

Page 400

SEVERABILITY
Section 301 of Pub. L. 101–616 provided that: ‘‘If any
provision of this Act [enacting sections 274f, 274g, 274k,
and 274l of this title, amending this section and sections 274 to 274d of this title, enacting provisions set
out as notes under this section and sections 274 and
274k of this title, and repealing provisions set out as a
note above], amendment made by this Act, or application of the provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act,
and the application of the provisions or amendments to
any person or circumstance shall not be affected.’’
CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS
Pub. L. 106–505, title VII, § 701(b), Nov. 13, 2000, 114
Stat. 2346, and Pub. L. 106–554, § 1(a)(1) [title II, § 219(a)],
Dec. 21, 2000, 114 Stat. 2763, 2763A–28, provided that:
‘‘Congress makes the following findings:
‘‘(1) Organ procurement organizations play an important role in the effort to increase organ donation
in the United States.
‘‘(2) The current process for the certification and
recertification of organ procurement organizations
conducted by the Department of Health and Human
Services has created a level of uncertainty that is
interfering with the effectiveness of organ procurement organizations in raising the level of organ donation.
‘‘(3) The General Accounting Office [now Government Accountability Office], the Institute of Medicine, and the Harvard School of Public Health have
identified substantial limitations in the organ procurement organization certification and recertification process and have recommended changes in
that process.
‘‘(4) The limitations in the recertification process
include:
‘‘(A) An exclusive reliance on population-based
measures of performance that do not account for
the potential in the population for organ donation
and do not permit consideration of other outcome
and process standards that would more accurately
reflect the relative capability and performance of
each organ procurement organization.
‘‘(B) A lack of due process to appeal to the Secretary of Health and Human Services for recertification on either substantive or procedural
grounds.
‘‘(5) The Secretary of Health and Human Services
has the authority under section 1138(b)(1)(A)(i) of the
Social Security Act (42 U.S.C. 1320b–8(b)(1)(A)(i)) to
extend the period for recertification of an organ procurement organization from 2 to 4 years on the basis
of its past practices in order to avoid the inappropriate disruption of the nation’s organ system.
‘‘(6) The Secretary of Health and Human Services
can use the extended period described in paragraph (5)
for recertification of all organ procurement organizations to—
‘‘(A) develop improved performance measures
that would reflect organ donor potential and interim outcomes, and to test these measures to ensure that they accurately measure performance differences among the organ procurement organizations; and
‘‘(B) improve the overall certification process by
incorporating process as well as outcome performance measures, and developing equitable processes
for appeals.’’
STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS
Pub. L. 106–310, div. A, title XXI, § 2101(b), Oct. 17,
2000, 114 Stat. 1156, provided that:
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this subsection as the
‘Secretary’) shall provide for a study to determine the
costs of immunosuppressive drugs that are provided to
children pursuant to organ transplants and to deter-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

mine the extent to which health plans and health insurance cover such costs. The Secretary may carry out
the study directly or through a grant to the Institute
of Medicine (or other public or nonprofit private entity).
‘‘(2) RECOMMENDATIONS REGARDING CERTAIN ISSUES.—
The Secretary shall ensure that, in addition to making
determinations under paragraph (1), the study under
such paragraph makes recommendations regarding the
following issues:
‘‘(A) The costs of immunosuppressive drugs that are
provided to children pursuant to organ transplants
and to determine the extent to which health plans,
health insurance and government programs cover
such costs.
‘‘(B) The extent of denial of organs to be released
for transplant by coroners and medical examiners.
‘‘(C) The special growth and developmental issues
that children have pre- and post-organ transplantation.
‘‘(D) Other issues that are particular to the special
health and transplantation needs of children.
‘‘(3) REPORT.—The Secretary shall ensure that, not
later than December 31, 2001, the study under paragraph
(1) is completed and a report describing the findings of
the study is submitted to the Congress.’’
STUDY ON HOSPITAL AGREEMENTS WITH ORGAN
PROCUREMENT AGENCIES
Pub. L. 103–432, title I, § 155(b), Oct. 31, 1994, 108 Stat.
4439, directed Office of Technology Assessment to conduct study to determine efficacy and fairness of requiring a hospital to enter into agreement under subsec.
(b)(3)(A) of this section with organ procurement agency
for service area in which such hospital is located and
impact of such requirement on efficacy and fairness of
organ procurement and distribution, and to submit to
Congress, not later than 2 years after Oct. 31, 1994, report containing findings of such study and implications
of such findings with respect to policies affecting organ
procurement and distribution.
TASK FORCE ON ORGAN PROCUREMENT AND
TRANSPLANTATION
Pub. L. 98–507, title I, §§ 101–105, Oct. 19, 1984, 98 Stat.
2339–2342, directed Secretary of Health and Human
Services, not later than 90 days after Oct. 19, 1984, to establish a Task Force on Organ Transplantation to conduct comprehensive examinations, prepare an assessment and report, and submit advice as to regulation of
the medical, legal, ethical, economic, and social issues
presented by human organ procurement and transplantation, with the final report due not later than 12
months after the Task Force is established and the
Task Force to terminate 3 months thereafter.
BONE MARROW REGISTRY DEMONSTRATION AND STUDY
Section 401 of Pub. L. 98–507 directed Secretary of
Health and Human Services to hold a conference on the
feasibility of establishing and the effectiveness of a national registry of voluntary bone marrow donors not
later than 9 months after Oct. 19, 1984, and if the conference found that it was feasible to establish a national registry of voluntary donors of bone marrow and
that such a registry was likely to be effective in matching donors with recipients, the Secretary was to establish a registry of voluntary donors of bone marrow not
later than six months after the completion of the conference, and further directed the Secretary, acting
through the Assistant Secretary for Health, to study
the establishment and implementation of the registry
to identify the issues presented by the establishment of
such a registry, to evaluate participation of bone marrow donors, to assess the implementation of the informed consent and confidentiality requirements, and
to determine if the establishment of a permanent bone
marrow registry was needed and appropriate, and to report the results of the study to Congress not later than
two years after the date the registry was established.

§ 274

§ 273a. National living donor mechanisms
The Secretary may establish and maintain
mechanisms to evaluate the long-term effects
associated with living organ donations by individuals who have served as living donors.
(July 1, 1944, ch. 373, title III, § 371A, as added
Pub. L. 108–216, § 7, Apr. 5, 2004, 118 Stat. 589.)
§ 273b. Report on the long-term health effects of
living organ donation
Not later than 1 year after December 21, 2007,
and annually thereafter, the Secretary of Health
and Human Services shall submit to the appropriate committees of Congress a report that details the progress made towards understanding
the long-term health effects of living organ donation.
(Pub. L. 110–144, § 3, Dec. 21, 2007, 121 Stat. 1814.)
CODIFICATION
Section was enacted as part of the Charlie W. Norwood Living Organ Donation Act, and not as part of the
Public Health Service Act which comprises this chapter.

§ 274. Organ procurement and transplantation
network
(a) Contract authority of Secretary; limitation;
available appropriations
The Secretary shall by contract provide for
the establishment and operation of an Organ
Procurement and Transplantation Network
which meets the requirements of subsection (b)
of this section. The amount provided under such
contract in any fiscal year may not exceed
$7,000,000. Funds for such contracts shall be
made available from funds available to the Public Health Service from appropriations for fiscal
years beginning after fiscal year 1984.
(b) Functions
(1) The Organ Procurement and Transplantation Network shall carry out the functions described in paragraph (2) and shall—
(A) be a private nonprofit entity that has an
expertise in organ procurement and transplantation, and
(B) have a board of directors—
(i) that includes representatives of organ
procurement organizations (including organizations that have received grants under
section 273 of this title), transplant centers,
voluntary health associations, and the general public; and
(ii) that shall establish an executive committee and other committees, whose chairpersons shall be selected to ensure continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network shall—
(A) establish in one location or through regional centers—
(i) a national list of individuals who need
organs, and
(ii) a national system, through the use of
computers and in accordance with established medical criteria, to match organs and
individuals included in the list, especially
individuals whose immune system makes it
difficult for them to receive organs,

§ 274

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) establish membership criteria and medical criteria for allocating organs and provide
to members of the public an opportunity to
comment with respect to such criteria,
(C) maintain a twenty-four-hour telephone
service to facilitate matching organs with individuals included in the list,
(D) assist organ procurement organizations
in the nationwide distribution of organs equitably among transplant patients,
(E) adopt and use standards of quality for
the acquisition and transportation of donated
organs, including standards for preventing the
acquisition of organs that are infected with
the etiologic agent for acquired immune deficiency syndrome,
(F) prepare and distribute, on a regionalized
basis (and, to the extent practicable, among
regions or on a national basis), samples of
blood sera from individuals who are included
on the list and whose immune system makes it
difficult for them to receive organs, in order
to facilitate matching the compatibility of
such individuals with organ donors,
(G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers,
(H) provide information to physicians and
other health professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donation and transplants,
(J) carry out studies and demonstration
projects for the purpose of improving procedures for organ procurement and allocation,
(K) work actively to increase the supply of
donated organs,
(L) submit to the Secretary an annual report
containing information on the comparative
costs and patient outcomes at each transplant
center affiliated with the organ procurement
and transplantation network,
(M) recognize the differences in health and
in organ transplantation issues between children and adults throughout the system and
adopt criteria, polices, and procedures that address the unique health care needs of children,
(N) carry out studies and demonstration
projects for the purpose of improving procedures for organ donation procurement and allocation, including but not limited to projects
to examine and attempt to increase transplantation among populations with special needs,
including children and individuals who are
members of racial or ethnic minority groups,
and among populations with limited access to
transportation, and
(O) provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age of 18.
(c) Consideration of critical comments
The Secretary shall establish procedures for—
(1) receiving from interested persons critical
comments relating to the manner in which the
Organ Procurement and Transplantation Network is carrying out the duties of the Network
under subsection (b) of this section; and
(2) the consideration by the Secretary of
such critical comments.
(July 1, 1944, ch. 373, title III, § 372, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2344;

Page 402

amended Pub. L. 100–607, title IV, § 403, Nov. 4,
1988, 102 Stat. 3115; Pub. L. 101–616, title II,
§ 202(a)–(c), Nov. 16, 1990, 104 Stat. 3283, 3284; Pub.
L. 106–310, div. A, title XXI, § 2101(a), Oct. 17,
2000, 114 Stat. 1156; Pub. L. 110–426, § 2, Oct. 15,
2008, 122 Stat. 4835.)
PRIOR PROVISIONS
A prior section 274, act July 1, 1944, ch. 373, title III,
§ 372, as added July 28, 1956, ch. 772, title II, § 201, 70
Stat. 710; amended June 25, 1959, Pub. L. 86–70,
§ 31(b)(2)–(4), 73 Stat. 148, related to grants to Alaska for
a mental health program and payment for construction
of hospital facilities, prior to the general revision of
this part by section 201 of Pub. L. 98–507.
Another section 372 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 941, § 1, 70 Stat. 960, which related to
functions of National Library of Medicine, was renumbered section 382 and classified to section 276 of this
title, prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20,
1985, 99 Stat. 879.
AMENDMENTS
2008—Subsec. (a). Pub. L. 110–426 substituted
‘‘$7,000,000’’ for ‘‘$2,000,000’’.
2000—Subsec. (b)(2)(M) to(O). Pub. L. 106–310 added
subpars. (M) to (O).
1990—Subsec. (b)(1)(A). Pub. L. 101–616, § 202(a)(1), substituted ‘‘that has an expertise in organ procurement
and transplantation’’ for ‘‘which is not engaged in any
activity unrelated to organ procurement’’.
Subsec. (b)(1)(B). Pub. L. 101–616, § 202(a)(2), amended
subpar. (B) generally. Prior to amendment, subpar. (B)
read as follows: ‘‘have a board of directors which includes representatives of organ procurement organizations (including organizations which have received
grants under section 273 of this title), transplant centers, voluntary health associations, and the general
public.’’
Subsec. (b)(2)(D). Pub. L. 101–616, § 202(b)(1), inserted
‘‘nationwide’’ after ‘‘organizations in the’’ and ‘‘equitably among transplant patients’’ after ‘‘organs’’.
Subsec. (b)(2)(F). Pub. L. 101–616, § 202(c), substituted
‘‘compatibility’’ for ‘‘compatability’’.
Subsec. (b)(2)(K), (L). Pub. L. 101–616, § 202(b)(2)–(4),
added subpars. (K) and (L).
1988—Subsec. (b)(2)(B), (C). Pub. L. 100–607, § 403(a)(1),
added subpar. (B) and redesignated former subpars. (B)
and (C) as (C) and (D), respectively.
Subsec. (b)(2)(D). Pub. L. 100–607, § 403(a)(1), (2), redesignated former subpar. (C) as (D) and substituted ‘‘organs’’ for ‘‘organs which cannot be placed within the
service areas of the organizations’’. Former subpar. (D)
redesignated (E).
Subsec. (b)(2)(E). Pub. L. 100–607, § 403(a)(1), (3), redesignated former subpar. (D) as (E) and inserted ‘‘including standards for preventing the acquisition of organs
that are infected with the etiologic agent for acquired
immune deficiency syndrome,’’ after ‘‘organs,’’. Former
subpar. (E) redesignated (F).
Subsec. (b)(2)(F). Pub. L. 100–607, § 403(a)(1), (4), redesignated former subpar. (E) as (F) and inserted ‘‘(and, to
the extent practicable, among regions or on a national
basis)’’ after ‘‘basis’’. Former subpar. (F) redesignated
(G).
Subsec. (b)(2)(G) to (I). Pub. L. 100–607, § 403(a)(1), redesignated former subpars. (F) to (H) as (G) to (I), respectively.
Subsec. (b)(2)(J). Pub. L. 100–607, § 403(a)(5), added subpar. (J).
Subsec. (c). Pub. L. 100–607, § 403(b), added subsec. (c).
EFFECTIVE DATE OF 1990 AMENDMENT
Section 202(d) of Pub. L. 101–616 provided that: ‘‘The
amendments made by subsection (a) [amending this
section] shall become effective on December 31, 1990.’’
REPORT; LIMITATION ON AMENDMENT BY PUB. L. 110–426
Pub. L. 110–426, § 3, Oct. 15, 2008, 122 Stat. 4835, provided that:

Page 403

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services shall request that the Executive Director of the Organ Procurement and Transplantation
Network submit to Congress, not later than 1 year after
the date of enactment of this Act [Oct. 15, 2008], a report that shall include—
‘‘(1) the identity of transplant programs that have
become inactive or have closed since the heart allocation policy change of 2006;
‘‘(2) the distance to the next closest operational
heart transplant center from such inactivated or
closed programs and an evaluation of whether or not
access to care has been reduced to the population previously serviced by such inactive or closed program;
‘‘(3) the number of patients with rural zip codes
that received transplants after the heart allocation
policy change of 2006 as compared with the number of
such patients that received such transplants prior to
such heart allocation policy change;
‘‘(4) a comparison of the number of transplants performed, the mortality rate for individuals on the
transplant waiting lists, and the post-transplant survival rate nationally and by region prior to and after
the heart allocation policy change of 2006; and
‘‘(5) specifically with respect to allosensitized patients, a comparison of the number of heart transplants performed, the mortality rate for individuals
on the heart transplant waiting lists, and the post
heart transplant survival rate nationally and by region prior to and after the heart allocation policy
change of 2006.
‘‘(b) LIMITATION ON FUNDING.—The increase provided
for in the amendment made by section 2 [amending this
section] shall not apply with respect to contracts entered into under section 372(a) of the Public Health
Service Act (42 U.S.C. 274(a)) after the date that is 1
year after the date of enactment of this Act [Oct. 15,
2008] if the Executive Director of the Organ Procurement and Transplantation Network fails to submit the
report under subsection (a).’’

§ 274a. Scientific registry
The Secretary shall, by grant or contract, develop and maintain a scientific registry of the
recipients of organ transplants. The registry
shall include such information respecting patients and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status of organ
transplantation. The Secretary shall prepare for
inclusion in the report under section 274d of this
title an analysis of information derived from the
registry.
(July 1, 1944, ch. 373, title III, § 373, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2345;
amended Pub. L. 100–607, title IV, § 404, Nov. 4,
1988, 102 Stat. 3116; Pub. L. 101–616, title I,
§ 101(b), Nov. 16, 1990, 104 Stat. 3282.)
PRIOR PROVISIONS
A prior section 373 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 907, § 1, 70 Stat. 960, which related to a
Board of Regents of National Library of Medicine, was
renumbered section 383 and classified to section 277 of
this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov.
20, 1985, 99 Stat. 879.
AMENDMENTS
1990—Pub. L. 101–616 struck out ‘‘and bone marrow
registry’’ after ‘‘Scientific registry’’ in section catchline and struck out subsec. (a) designation and subsec.
(b) which directed establishment of bone marrow registry and authorized appropriations for fiscal years 1989
and 1990 for such purpose.
1988—Pub. L. 100–607 inserted ‘‘and bone marrow registry’’ in section catchline, designated existing text as
subsec. (a), and added subsec. (b).

§ 274b

§ 274b. General provisions respecting grants and
contracts
(a) Application requirement
No grant may be made under this part or contract entered into under section 274 or 274a of
this title unless an application therefor has been
submitted to, and approved by, the Secretary.
Such an application shall be in such form and
shall be submitted in such manner as the Secretary shall by regulation prescribe.
(b) Special considerations and priority; planning
and establishment grants
(1) A grant for planning under section 273(a)(1)
of this title may be made for one year with respect to any organ procurement organization
and may not exceed $100,000.
(2) Grants under section 273(a)(2) of this title
may be made for two years. No such grant may
exceed $500,000 for any year and no organ procurement organization may receive more than
$800,000 for initial operation or expansion.
(3) Grants or contracts under section 273(a)(3)
of this title may be made for not more than 3
years.
(c) Determination of grant amount; terms of payment; recordkeeping; access for purposes of
audits and examination of records
(1) The Secretary shall determine the amount
of a grant or contract made under section 273 or
274a of this title. Payments under such grants
and contracts may be made in advance on the
basis of estimates or by the way of reimbursement, with necessary adjustments on account of
underpayments or overpayments, and in such installments and on such terms and conditions as
the Secretary finds necessary to carry out the
purposes of such grants and contracts.
(2)(A) Each recipient of a grant or contract
under section 273 or 274a of this title shall keep
such records as the Secretary shall prescribe, including records which fully disclose the amount
and disposition by such recipient of the proceeds
of such grant or contract, the total cost of the
undertaking in connection with which such
grant or contract was made, and the amount of
that portion of the cost of the undertaking supplied by other sources, and such other records as
will facilitate an effective audit.
(B) The Secretary and the Comptroller General of the United States, or any of their duly
authorized representatives, shall have access for
the purpose of audit and examination to any
books, documents, papers, and records of the recipient of a grant or contract under section 273
or 274a of this title that are pertinent to such
grant or contract.
(d) ‘‘Transplant center’’ and ‘‘organ’’ defined
For purposes of this part:
(1) The term ‘‘transplant center’’ means a
health care facility in which transplants of organs are performed.
(2) The term ‘‘organ’’ means the human kidney, liver, heart, lung, pancreas, and any other
human organ (other than corneas and eyes)
specified by the Secretary by regulation and
for purposes of section 274a of this title, such
term includes bone marrow.
(July 1, 1944, ch. 373, title III, § 374, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2345;

§ 274c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 404

amended Pub. L. 100–607, title IV, § 402(b), Nov. 4,
1988, 102 Stat. 3114; Pub. L. 101–616, title II, § 203,
Nov. 16, 1990, 104 Stat. 3284.)

title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.

PRIOR PROVISIONS

A prior section 375 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 907, § 1, 70 Stat. 962, which related to
definitions, was renumbered section 385 and classified
to section 279 of this title, prior to repeal by Pub. L.
99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.

A prior section 374 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 907, § 1, 70 Stat. 961, which related to acceptance and administration of gifts to National Library of Medicine and to establishment of memorials to
donors, was renumbered section 384 and classified to
section 278 of this title, prior to repeal by Pub. L.
99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
AMENDMENTS
1990—Subsec. (a). Pub. L. 101–616, § 203(1), substituted
‘‘No grant may be made under this part’’ for ‘‘No grant
may be made under section 273 or 274a of this title’’.
Subsec. (b). Pub. L. 101–616, § 203(2), redesignated par.
(2) as (1) and substituted ‘‘section 273(a)(1)’’ for ‘‘section
273’’, struck out former par. (1) which set forth factors
in considering applications for section 273 grants, redesignated par. (3) as (2) and substituted ‘‘section
273(a)(2)’’ for ‘‘paragraphs (2) and (3) of section 273(a)’’,
and added par. (3).
Subsec. (c). Pub. L. 101–616, § 203(3), inserted ‘‘or contract’’ after ‘‘grant’’ wherever appearing and ‘‘and contracts’’ after ‘‘grants’’ wherever appearing.
1988—Subsec. (b)(3). Pub. L. 100–607 substituted ‘‘paragraphs (2) and (3) of section 273(a) of this title’’ for
‘‘section 273 of this title for the establishment, initial
operation, or expansion of organ procurement organizations’’.

§ 274c. Administration
The Secretary shall designate and maintain an
identifiable administrative unit in the Public
Health Service to—
(1) administer this part and coordinate with
the organ procurement activities under title
XVIII of the Social Security Act [42 U.S.C. 1395
et seq.],
(2) conduct a program of public information
to inform the public of the need for organ donations,
(3) provide technical assistance to organ procurement organizations, the Organ Procurement and Transplantation Network established under section 274 of this title, and other
entities in the health care system involved in
organ donations, procurement, and transplants, and
(4) provide information—
(i) to patients, their families, and their
physicians about transplantation; and
(ii) to patients and their families about
the resources available nationally and in
each State, and the comparative costs and
patient outcomes at each transplant center
affiliated with the organ procurement and
transplantation network, in order to assist
the patients and families with the costs associated with transplantation.
(July 1, 1944, ch. 373, title III, § 375, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2346;
amended Pub. L. 100–607, title IV, § 405, Nov. 4,
1988, 102 Stat. 3116; Pub. L. 101–616, title II, § 204,
Nov. 16, 1990, 104 Stat. 3285.)

PRIOR PROVISIONS

AMENDMENTS
1990—Pub. L. 101–616, § 204(a), struck out ‘‘, during fiscal years 1985 through 1990,’’ after ‘‘The Secretary
shall’’.
Par. (3). Pub. L. 101–616, § 204(b)(1), struck out ‘‘receiving funds under section 273 of this title’’ after ‘‘organ
procurement organizations’’.
Par. (4). Pub. L. 101–616, § 204(b)(2), amended par. (4)
generally. Prior to amendment, par. (4) read as follows:
‘‘not later than April 1 of each of the years 1989 and
1990, submit to the Congress a report on the status of
organ donation and coordination services and include
in the report an analysis of the efficiency and effectiveness of the procurement and allocation of organs and a
description of problems encountered in the procurement and allocation of organs.’’
1988—Pub. L. 100–607, in introductory provisions, substituted ‘‘1985 through 1990’’ for ‘‘1985, 1986, 1987, and
1988’’ and, in par. (4), substituted ‘‘not later than April
1 of each of the years 1989 and 1990, submit to the Congress a report’’ for ‘‘one year after the date on which
the Task Force on Organ Transplantation transmits its
final report under section 104(c) of the National Organ
Transplant Act, and annually thereafter through fiscal
year 1988, submit to Congress an annual report’’.

§ 274d. Report
Not later than February 10 of 1991 and of each
second year thereafter, the Secretary shall publish, and submit to the Committee on Energy
and Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate.1 a report on the scientific
and clinical status of organ transplantation. The
Secretary shall consult with the Director of the
National Institutes of Health and the Commissioner of the Food and Drug Administration in
the preparation of the report.
(July 1, 1944, ch. 373, title III, § 376, as added Pub.
L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2346;
amended Pub. L. 100–607, title IV, § 406, Nov. 4,
1988, 102 Stat. 3116; Pub. L. 101–616, title II, § 205,
Nov. 16, 1990, 104 Stat. 3285.)
PRIOR PROVISIONS
A prior section 376 of act July 1, 1944, added by act
Aug. 3, 1956, ch. 907, § 1, 70 Stat. 962, which related to Library facilities, was renumbered section 386 and classified to section 280 of this title, prior to repeal by Pub.
L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
AMENDMENTS
1990—Pub. L. 101–616 substituted ‘‘Not later than February 10 of 1991 and of each second year thereafter, the
Secretary shall publish, and submit to the Committee
on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.’’ for ‘‘The Secretary shall, not
later than October 1 of each year, publish’’.
1988—Pub. L. 100–607 substituted ‘‘shall, not later
than October 1 of each year,’’ for ‘‘shall annually’’.

REFERENCES IN TEXT

CHANGE OF NAME

The Social Security Act, referred to in par. (1), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title
XVIII of the Social Security Act is classified generally
to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this

Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
1 So

in original. The period probably should be a comma.

Page 405

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 274e. Prohibition of organ purchases
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any
human organ for valuable consideration for use
in human transplantation if the transfer affects
interstate commerce. The preceding sentence
does not apply with respect to human organ
paired donation.
(b) Penalties
Any person who violates subsection (a) of this
section shall be fined not more than $50,000 or
imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a) of this section:
(1) The term ‘‘human organ’’ means the
human (including fetal) kidney, liver, heart,
lung, pancreas, bone marrow, cornea, eye,
bone, and skin or any subpart thereof and any
other human organ (or any subpart thereof, including that derived from a fetus) specified by
the Secretary of Health and Human Services
by regulation.
(2) The term ‘‘valuable consideration’’ does
not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality
control, and storage of a human organ or the
expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.
(3) The term ‘‘interstate commerce’’ has the
meaning prescribed for it by section 321(b) of
title 21.
(4) The term ‘‘human organ paired donation’’
means the donation and receipt of human organs under the following circumstances:
(A) An individual (referred to in this paragraph as the ‘‘first donor’’) desires to make
a living donation of a human organ specifically to a particular patient (referred to in
this paragraph as the ‘‘first patient’’), but
such donor is biologically incompatible as a
donor for such patient.
(B) A second individual (referred to in this
paragraph as the ‘‘second donor’’) desires to
make a living donation of a human organ
specifically to a second particular patient
(referred to in this paragraph as the ‘‘second
patient’’), but such donor is biologically incompatible as a donor for such patient.
(C) Subject to subparagraph (D), the first
donor is biologically compatible as a donor
of a human organ for the second patient, and
the second donor is biologically compatible
as a donor of a human organ for the first patient.

§ 274f

(D) If there is any additional donor-patient
pair as described in subparagraph (A) or (B),
each donor in the group of donor-patient
pairs is biologically compatible as a donor of
a human organ for a patient in such group.
(E) All donors and patients in the group of
donor-patient pairs (whether 2 pairs or more
than 2 pairs) enter into a single agreement
to donate and receive such human organs,
respectively, according to such biological
compatibility in the group.
(F) Other than as described in subparagraph (E), no valuable consideration is
knowingly acquired, received, or otherwise
transferred with respect to the human organs referred to in such subparagraph.
(Pub. L. 98–507, title III, § 301, Oct. 19, 1984, 98
Stat. 2346; Pub. L. 100–607, title IV, § 407, Nov. 4,
1988, 102 Stat. 3116; Pub. L. 110–144, § 2, Dec. 21,
2007, 121 Stat. 1813.)
CODIFICATION
Section was enacted as part of the National Organ
Transplant Act, and not as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–144, § 2(1), inserted at
end ‘‘The preceding sentence does not apply with respect to human organ paired donation.’’
Subsec. (c)(4). Pub. L. 110–144, § 2(2), added par. (4).
1988—Subsec. (c)(1). Pub. L. 100–607 amended par. (1)
generally. Prior to amendment, par. (1) read as follows:
‘‘The term ‘human organ’ means the human kidney,
liver, heart, lung, pancreas, bone marrow, cornea, eye,
bone, and skin, and any other human organ specified by
the Secretary of Health and Human Services by regulation.’’
NO IMPACT ON SOCIAL SECURITY TRUST FUND
Pub. L. 110–144, § 4, Dec. 21, 2007, 121 Stat. 1814, provided that: ‘‘Nothing in this Act [see Short Title of 2007
Amendment note set out under section 201 of this title]
(or an amendment made by this Act) shall be construed
to alter or amend the Social Security Act (42 U.S.C. 301
et seq.) (or any regulation promulgated under that
Act).’’

§ 274f. Reimbursement of travel and subsistence
expenses incurred toward living organ donation
(a) In general
The Secretary may award grants to States,
transplant centers, qualified organ procurement
organizations under section 273 of this title, or
other public or private entities for the purpose
of—
(1) providing for the reimbursement of travel
and subsistence expenses incurred by individuals toward making living donations of their
organs (in this section referred to as ‘‘donating individuals’’); and
(2) providing for the reimbursement of such
incidental nonmedical expenses that are so incurred as the Secretary determines by regulation to be appropriate.
(b) Preference
The Secretary shall, in carrying out subsection (a) of this section, give preference to
those individuals that the Secretary determines
are more likely to be otherwise unable to meet
such expenses.

§ 274f–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Certain circumstances
The Secretary may, in carrying out subsection
(a) of this section, consider—
(1) the term ‘‘donating individuals’’ as including individuals who in good faith incur
qualifying expenses toward the intended donation of an organ but with respect to whom, for
such reasons as the Secretary determines to
be appropriate, no donation of the organ occurs; and
(2) the term ‘‘qualifying expenses’’ as including the expenses of having relatives or other
individuals, not to exceed 2, accompany or assist the donating individual for purposes of
subsection (a) of this section (subject to making payment for only those types of expenses
that are paid for a donating individual).
(d) Relationship to payments under other programs
An award may be made under subsection (a) of
this section only if the applicant involved agrees
that the award will not be expended to pay the
qualifying expenses of a donating individual to
the extent that payment has been made, or can
reasonably be expected to be made, with respect
to such expenses—
(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program;
(2) by an entity that provides health services
on a prepaid basis; or
(3) by the recipient of the organ.
(e) Definitions
For purposes of this section:
(1) The term ‘‘donating individuals’’ has the
meaning indicated for such term in subsection
(a)(1) of this section, subject to subsection
(c)(1) of this section.
(2) The term ‘‘qualifying expenses’’ means
the expenses authorized for purposes of subsection (a) of this section, subject to subsection (c)(2) of this section.
(f) Authorization of appropriations
For the purpose of carrying out this section,
there is authorized to be appropriated $5,000,000
for each of the fiscal years 2005 through 2009.
(July 1, 1944, ch. 373, title III, § 377, as added Pub.
L. 101–616, title II, § 206(a), Nov. 16, 1990, 104 Stat.
3285; amended Pub. L. 108–216, § 3, Apr. 5, 2004, 118
Stat. 584.)
AMENDMENTS
2004—Pub. L. 108–216 amended section catchline and
text generally, substituting provisions relating to reimbursement of travel and subsistence expenses incurred toward living organ donation for provisions requiring the Comptroller General to study and report on
organ procurement and allocation.

§ 274f–1. Public awareness; studies and demonstrations
(a) Organ donation public awareness program
The Secretary shall, directly or through
grants or contracts, establish a public education
program in cooperation with existing national
public awareness campaigns to increase awareness about organ donation and the need to provide for an adequate rate of such donations.

Page 406

(b) Studies and demonstrations
The Secretary may make peer-reviewed grants
to, or enter into peer-reviewed contracts with,
public and nonprofit private entities for the purpose of carrying out studies and demonstration
projects to increase organ donation and recovery rates, including living donation.
(c) Grants to States
(1) In general
The Secretary may make grants to States
for the purpose of assisting States in carrying
out organ donor awareness, public education,
and outreach activities and programs designed
to increase the number of organ donors within
the State, including living donors.
(2) Eligibility
To be eligible to receive a grant under this
subsection, a State shall—
(A) submit an application to the Department in the form prescribed;
(B) establish yearly benchmarks for improvement in organ donation rates in the
State; and
(C) report to the Secretary on an annual
basis a description and assessment of the
State’s use of funds received under this subsection, accompanied by an assessment of
initiatives for potential replication in other
States.
(3) Use of funds
Funds received under this subsection may be
used by the State, or in partnership with other
public agencies or private sector institutions,
for education and awareness efforts, information dissemination, activities pertaining to
the State donor registry, and other innovative
donation specific initiatives, including living
donation.
(d) Educational activities
The Secretary, in coordination with the Organ
Procurement and Transplantation Network and
other appropriate organizations, shall support
the development and dissemination of educational materials to inform health care professionals and other appropriate professionals in issues surrounding organ, tissue, and eye donation
including evidence-based proven methods to approach patients and their families, cultural sensitivities, and other relevant issues.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$15,000,000 for fiscal year 2005, and such sums as
may be necessary for each of the fiscal years
2006 through 2009. Such authorization of appropriations is in addition to any other authorizations of appropriations that are available for
such purpose.
(July 1, 1944, ch. 373, title III, § 377A, as added
Pub. L. 108–216, § 4, Apr. 5, 2004, 118 Stat. 585.)
§ 274f–2. Grants regarding hospital organ donation coordinators
(a) Authority
(1) In general
The Secretary may award grants to qualified
organ procurement organizations and hos-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

pitals under section 273 of this title to establish programs coordinating organ donation activities of eligible hospitals and qualified
organ procurement organizations under section 273 of this title. Such activities shall be
coordinated to increase the rate of organ donations for such hospitals.
(2) Eligible hospital
For purposes of this section, the term ‘‘eligible hospital’’ means a hospital that performs
significant trauma care, or a hospital or consortium of hospitals that serves a population
base of not fewer than 200,000 individuals.
(b) Administration of coordination program
A condition for the receipt of a grant under
subsection (a) of this section is that the applicant involved agree that the program under such
subsection will be carried out jointly—
(1) by representatives from the eligible hospital and the qualified organ procurement organization with respect to which the grant is
made; and
(2) by such other entities as the representatives referred to in paragraph (1) may designate.
(c) Requirements
Each entity receiving a grant under subsection (a) of this section shall—
(1) establish joint organ procurement organization and hospital designated leadership responsibility and accountability for the
project;
(2) develop mutually agreed upon overall
project performance goals and outcome measures, including interim outcome targets; and
(3) collaboratively design and implement an
appropriate data collection process to provide
ongoing feedback to hospital and organ procurement organization leadership on project
progress and results.
(d) Rule of construction
Nothing in this section shall be construed to
interfere with regulations in force on April 5,
2004.
(e) Evaluations
Within 3 years after the award of grants under
this section, the Secretary shall ensure an evaluation of programs carried out pursuant to subsection (a) of this section in order to determine
the extent to which the programs have increased
the rate of organ donation for the eligible hospitals involved.
(f) Matching requirement
The Secretary may not award a grant to a
qualifying organ donation entity under this section unless such entity agrees that, with respect
to costs to be incurred by the entity in carrying
out activities for which the grant was awarded,
the entity shall contribute (directly or through
donations from public or private entities) nonFederal contributions in cash or in kind, in an
amount equal to not less than 30 percent of the
amount of the grant awarded to such entity.
(g) Funding
For the purpose of carrying out this section,
there are authorized to be appropriated $3,000,000

§ 274f–3

for fiscal year 2005, and such sums as may be
necessary for each of fiscal years 2006 through
2009.
(July 1, 1944, ch. 373, title III, § 377B, as added
Pub. L. 108–216, § 4, Apr. 5, 2004, 118 Stat. 586.)
§ 274f–3. Studies relating to organ donation and
the recovery, preservation, and transportation of organs
(a) Development of supportive information
The Secretary, acting through the Director of
the Agency for Healthcare Research and Quality, shall develop scientific evidence in support
of efforts to increase organ donation and improve the recovery, preservation, and transportation of organs.
(b) Activities
In carrying out subsection (a) of this section,
the Secretary shall—
(1) conduct or support evaluation research to
determine
whether
interventions,
technologies, or other activities improve the effectiveness, efficiency, or quality of existing
organ donation practice;
(2) undertake or support periodic reviews of
the scientific literature to assist efforts of
professional societies to ensure that the clinical practice guidelines that they develop reflect the latest scientific findings;
(3) ensure that scientific evidence of the research and other activities undertaken under
this section is readily accessible by the organ
procurement workforce; and
(4) work in coordination with the appropriate professional societies as well as the
Organ Procurement and Transplantation Network and other organ procurement and transplantation organizations to develop evidence
and promote the adoption of such proven practices.
(c) Research and dissemination
The Secretary, acting through the Director of
the Agency for Healthcare Research and Quality, as appropriate, shall provide support for research and dissemination of findings, to—
(1) develop a uniform clinical vocabulary for
organ recovery;
(2) apply information technology and telecommunications to support the clinical operations of organ procurement organizations;
(3) enhance the skill levels of the organ procurement workforce in undertaking quality
improvement activities; and
(4) assess specific organ recovery, preservation, and transportation technologies.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $2,000,000
for fiscal year 2005, and such sums as may be
necessary for each of fiscal years 2006 through
2009.
(July 1, 1944, ch. 373, title III, § 377C, as added
Pub. L. 108–216, § 5, Apr. 5, 2004, 118 Stat. 587.)

§ 274f–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 274f–4. Report relating to organ donation and
the recovery, preservation, and transportation of organs
(a) In general
Not later than December 31, 2005, and every 2
years thereafter, the Secretary shall report to
the appropriate committees of Congress on the
activities of the Department carried out pursuant to this part, including an evaluation describing the extent to which the activities have
affected the rate of organ donation and recovery.
(b) Requirements
To the extent practicable, each report submitted under subsection (a) of this section shall—
(1) evaluate the effectiveness of activities,
identify effective activities, and disseminate
such findings with respect to organ donation
and recovery;
(2) assess organ donation and recovery activities that are recently completed, ongoing,
or planned; and
(3) evaluate progress on the implementation
of the plan required under subsection (c)(5) of
this section.
(c) Initial report requirements
The initial report under subsection (a) of this
section shall include the following:
(1) An evaluation of the organ donation
practices of organ procurement organizations,
States, other countries, and other appropriate
organizations including an examination across
all populations, including those with low
organ donation rates, of—
(A) existing barriers to organ donation;
and
(B) the most effective donation and recovery practices.
(2) An evaluation of living donation practices and procedures. Such evaluation shall include an assessment of issues relating to informed consent and the health risks associated with living donation (including possible
reduction of long-term effects).
(3) An evaluation of—
(A) federally supported or conducted organ
donation efforts and policies, as well as federally supported or conducted basic, clinical,
and health services research (including research on preservation techniques and organ
rejection and compatibility); and
(B) the coordination of such efforts across
relevant agencies within the Department
and throughout the Federal Government.
(4) An evaluation of the costs and benefits of
State donor registries, including the status of
existing State donor registries, the effect of
State donor registries on organ donation
rates, issues relating to consent, and recommendations regarding improving the effectiveness of State donor registries in increasing
overall organ donation rates.
(5) A plan to improve federally supported or
conducted organ donation and recovery activities, including, when appropriate, the establishment of baselines and benchmarks to
measure overall outcomes of these programs.
Such plan shall provide for the ongoing coordi-

Page 408

nation of federally supported or conducted
organ donation and research activities.
(July 1, 1944, ch. 373, title III, § 377D, as added
Pub. L. 108–216, § 6, Apr. 5, 2004, 118 Stat. 588.)
§ 274g. Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated $8,000,000
for fiscal year 1991, and such sums as may be
necessary for each of the fiscal years 1992 and
1993.
(July 1, 1944, ch. 373, title III, § 378, as added Pub.
L. 101–616, title II, § 206(a), Nov. 16, 1990, 104 Stat.
3285; amended Pub. L. 105–196, § 4(1), July 16, 1998,
112 Stat. 636.)
AMENDMENTS
1998—Pub. L. 105–196 made technical amendment relating to placement of section within part H of this
subchapter.

PART H–1—Stephanie Tubbs Jones Gift of Life
Medal
CODIFICATION
Part was enacted as part of the Stephanie Tubbs
Jones Gift of Life Medal Act of 2008, and not as part of
the Public Health Service Act which comprises this
chapter.

§ 274i. Eligibility requirements for Stephanie
Tubbs Jones Gift of Life Medal
(a) In general
Subject to the provisions of this section and
the availability of funds under this part, any
organ donor, or the family of any organ donor,
shall be eligible for a Stephanie Tubbs Jones
Gift of Life Medal (hereafter in this part referred to as a ‘‘medal’’).
(b) Documentation
The Secretary of Health and Human Services
shall direct the entity operating the Organ Procurement and Transplantation Network to—
(1) establish an application procedure requiring the relevant organ procurement organization through which an individual or family of
the individual made an organ donation, to submit to such entity documentation supporting
the eligibility of the individual or the family,
respectively, to receive a medal;
(2) determine through the documentation
provided and, if necessary, independent investigation whether the individual or family, respectively, is eligible to receive such a medal;
and
(3) arrange for the presentation to the relevant organ procurement organization all
medals struck pursuant to section 274i–2 of
this title to individuals or families that are
determined to be eligible to receive medals.
(c) Limitation
(1) In general
Except as provided in paragraph (2), only 1
medal may be presented to a family under subsection (b). Such medal shall be presented to
the donating family member, or in the case of
a deceased donor, the family member who
signed the consent form authorizing, or who

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

otherwise authorized, the donation of the
organ involved.
(2) Exception
In the case of a family in which more than
1 member is an organ donor, a medal may be
presented for each such organ donor.

§ 274i–4

(a) In general
The Organ Procurement and Transplantation
Network may collect funds to offset expenditures relating to the issuance of medals authorized under this part.
(b) Payment of funds
(1) In general
Except as provided in paragraph (2), all
funds received by the Organ Procurement and
Transplantation Network under subsection (a)
shall be promptly paid by the Organ Procurement and Transplantation Network to the
Secretary of Health and Human Services for
purposes of purchasing medals under this part
for distribution and paying the administrative
costs of the Secretary of Health and Human
Services and the Secretary of the Treasury in
carrying out this part.
(2) Limitation
Not more than 7 percent of any funds received under subsection (a) may be used to pay
administrative costs, and fundraising costs to
solicit funds under subsection (a), incurred by
the Organ Procurement and Transplantation
Network in carrying out this part.
(c) Prohibition on use of Federal funds
No Federal funds (including amounts appropriated for use by the Organ Procurement and
Transplantation Network) may be used for purposes of carrying out this part, including purchasing medals under this part or paying the administrative costs of the Secretary of Health
and Human Services or the Secretary of the
Treasury in carrying out this part.

(A) selected by the Secretary of the Treasury, in consultation with the Secretary of
Health and Human Services, the Organ Procurement and Transplantation Network, interested members of the family of Stephanie
Tubbs Jones, Dr. William H. Frist, and the
Commission of Fine Arts; and
(B) reviewed by the Citizens Coin Advisory
Committee.
(c) National medals
The medals struck pursuant to this section are
national medals for purposes of chapter 51 of
title 31.
(d) Striking and delivery of minimum-sized lots
The Secretary of the Treasury shall strike and
deliver to the Secretary of Health and Human
Services no fewer than 100 medals at any time
pursuant to an order by such Secretary.
(e) Cost of medals
Medals struck under this section and sold to
the Secretary of Health and Human Services for
distribution in accordance with this part shall
be sold to the Secretary of Health and Human
Services at a price sufficient to cover the cost of
designing and striking the medals, including
labor, materials, dies, use of machinery, and
overhead expenses.
(f) No expenditures in advance of receipt of fund
(1) In general
The Secretary of the Treasury shall not
strike or distribute any medals under this part
until such time as the Secretary of Health and
Human Services certifies that sufficient funds
have been received by such Secretary to cover
the cost of the medals ordered.
(2) Design in advance of order
Notwithstanding paragraph (1), the Secretary of the Treasury may begin designing
the medal at any time after October 14, 2008,
and take such other action as may be necessary to be prepared to strike such medals
upon receiving the certification described in
such paragraph, including preparing dies and
striking test pieces.

(Pub. L. 110–413, § 3, Oct. 14, 2008, 122 Stat. 4339.)

(Pub. L. 110–413, § 4, Oct. 14, 2008, 122 Stat. 4339.)

§ 274i–2. Design and production of medal

§ 274i–3. Medals not treated as valuable consideration

(Pub. L. 110–413, § 2, Oct. 14, 2008, 122 Stat. 4338.)
§ 274i–1. Solicitation of donations; prohibition on
use of Federal funds

(a) In general
Subject to the provisions of this section, the
Secretary of the Treasury shall design and
strike the Stephanie Tubbs Jones Gift of Life
Medals, each of which shall—
(1) weigh 250 grams;
(2) have a diameter of 3 inches; and
(3) consist of bronze.
(b) Design
(1) In general
The design of the medals shall commemorate the compassion and courage manifested
by and the sacrifices made by organ donors
and their families, and the medals shall bear
suitable emblems, devices, and inscriptions.
(2) Selection
The design of medals struck under this section shall be—

A medal under this part shall not be treated as
valuable consideration for purposes of section
274e(a) of this title.
(Pub. L. 110–413, § 5, Oct. 14, 2008, 122 Stat. 4340.)
§ 274i–4. Definitions
For purposes of this part:
(1) Organ
The term ‘‘organ’’ has the meaning given
such term in section 121.2 of title 42, Code of
Federal Regulations.
(2) Organ procurement organization
The term ‘‘organ procurement organization’’
means a qualified organ procurement organization described in section 273(b)(1) of this
title.

§ 274k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Organ Procurement and Transplantation
Network
The term ‘‘Organ Procurementand 1 Transplantation Network’’ means the Organ Procurement and Transplantation Network established under section 274 of this title.
(Pub. L. 110–413, § 6, Oct. 14, 2008, 122 Stat. 4340.)
PART I—C.W. BILL YOUNG CELL
TRANSPLANTATION PROGRAM
AMENDMENTS
2005—Pub. L. 109–129, § 3(e), Dec. 20, 2005, 119 Stat. 2562,
substituted ‘‘C.W. Bill Young Cell Transplantation Program’’ for ‘‘National Bone Marrow Donor Registry’’ in
part heading.
1990—Pub. L. 101–616, title I, § 101(a)(2), Nov. 16, 1990,
104 Stat. 3279, added part I ‘‘National Bone Marrow
Donor Registry’’ and redesignated former part I ‘‘Biomedical Ethics’’ as J.
1985—Pub. L. 99–158, §§ 3(b), 11, Nov. 20, 1985, 99 Stat.
879, 883, added part I ‘‘Biomedical Ethics’’, and repealed
former part I ‘‘National Library of Medicine’’.
1970—Pub. L. 91–212, § 10(a)(2), Mar. 13, 1970, 84 Stat. 66,
redesignated part H ‘‘National Library of Medicine’’, as
part I ‘‘National Library of Medicine’’.

§ 274k. National Program
(a) Establishment
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall by one or more contracts establish and maintain a C.W. Bill Young Cell
Transplantation Program (referred to in this
section as the ‘‘Program’’), successor to the National Bone Marrow Donor Registry, that has
the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and
cord blood, and that meets the requirements of
this section. The Secretary may award a separate contract to perform each of the major functions of the Program described in paragraphs (1)
and (2) of subsection (d) of this section if deemed
necessary by the Secretary to operate an effective and efficient system that is in the best interest of patients. The Secretary shall conduct a
separate competition for the initial establishment of the cord blood functions of the Program. The Program shall be under the general
supervision of the Secretary. The Secretary
shall establish an Advisory Council to advise,
assist, consult with, and make recommendations
to the Secretary on matters related to the activities carried out by the Program. The members of the Advisory Council shall be appointed
in accordance with the following:
(1) Each member of the Advisory Council
shall serve for a term of 2 years, and each such
member may serve as many as 3 consecutive 2year terms, except that—
(A) such limitations shall not apply to the
Chair of the Advisory Council (or the Chairelect) or to the member of the Advisory
Council who most recently served as the
Chair; and
(B) one additional consecutive 2-year term
may be served by any member of the Advisory Council who has no employment, gov1 So

in original. Probably should be ‘‘Procurement and’’.

Page 410

ernance, or financial affiliation with any
donor center, recruitment organization,
transplant center, or cord blood bank.
(2) A member of the Advisory Council may
continue to serve after the expiration of the
term of such member until a successor is appointed.
(3) In order to ensure the continuity of the
Advisory Council, the Advisory Council shall
be appointed so that each year the terms of
approximately one-third of the members of the
Advisory Council expire.
(4) The membership of the Advisory Council—
(A) shall include as voting members a balanced number of representatives including
representatives of marrow donor centers and
marrow transplant centers, representatives
of cord blood banks and participating birthing hospitals, recipients of a bone marrow
transplant, recipients of a cord blood transplant, persons who require such transplants,
family members of such a recipient or family members of a patient who has requested
the assistance of the Program in searching
for an unrelated donor of bone marrow or
cord blood, persons with expertise in bone
marrow and cord blood transplantation, persons with expertise in typing, matching, and
transplant outcome data analysis, persons
with expertise in the social sciences, basic
scientists with expertise in the biology of
adult stem cells, and members of the general
public; and
(B) shall include as nonvoting members
representatives from the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department
of the Navy, the Division of Transplantation
of the Health Resources and Services Administration, the Food and Drug Administration, and the National Institutes of Health.
(5) Members of the Advisory Council shall be
chosen so as to ensure objectivity and balance
and reduce the potential for conflicts of interest. The Secretary shall establish bylaws and
procedures—
(A) to prohibit any member of the Advisory Council who has an employment, governance, or financial affiliation with a donor
center, recruitment organization, transplant
center, or cord blood bank from participating in any decision that materially affects
the center, recruitment organization, transplant center, or cord blood bank; and
(B) to limit the number of members of the
Advisory Council with any such affiliation.
(6) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit to Congress
an annual report on the activities carried out
under this section.
(b) Accreditation
The Secretary shall, through a public process,
recognize one or more accreditation entities for
the accreditation of cord blood banks.
(c) Informed consent
The Secretary shall, through a public process,
examine issues of informed consent, including—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) the appropriate timing of such consent;
and
(2) the information provided to the maternal
donor regarding all of her medically appropriate cord blood options.
Based on such examination, the Secretary shall
require that the standards used by the accreditation entities recognized under subsection (b)
of this section ensure that a cord blood unit is
acquired with the informed consent of the maternal donor.
(d) Functions
(1) Bone marrow functions
With respect to bone marrow, the Program
shall—
(A) operate a system for identifying,
matching, and facilitating the distribution
of bone marrow that is suitably matched to
candidate patients;
(B) consistent with paragraph (3), permit
transplant physicians, other appropriate
health care professionals, and patients to
search by means of electronic access all
available bone marrow donors listed in the
Program;
(C) carry out a program for the recruitment of bone marrow donors in accordance
with subsection (e) of this section, including
with respect to increasing the representation of racial and ethnic minority groups
(including persons of mixed ancestry) in the
enrollment of the Program;
(D) maintain and expand medical contingency response capabilities, in coordination
with Federal programs, to prepare for and
respond effectively to biological, chemical,
or radiological attacks, and other public
health emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from disease can
be used to support casualties with marrow
damage;
(E) carry out informational and educational activities in accordance with subsection (e) of this section;
(F) at least annually update information
to account for changes in the status of individuals as potential donors of bone marrow;
(G) provide for a system of patient advocacy through the office established under
subsection (h) of this section;
(H) provide case management services for
any potential donor of bone marrow to
whom the Program has provided a notice
that the potential donor may be suitably
matched to a particular patient through the
office established under subsection (h) of
this section;
(I) with respect to searches for unrelated
donors of bone marrow that are conducted
through the system under subparagraph (A),
collect, analyze, and publish data in a standardized electronic format on the number and
percentage of patients at each of the various
stages of the search process, including data
regarding the furthest stage reached, the
number and percentage of patients who are
unable to complete the search process, and
the reasons underlying such circumstances;
(J) support studies and demonstration and
outreach projects for the purpose of increas-

§ 274k

ing the number of individuals who are willing to be marrow donors to ensure a genetically diverse donor pool; and
(K) facilitate research with the appropriate Federal agencies to improve the availability, efficiency, safety, and cost of transplants from unrelated donors and the effectiveness of Program operations.
(2) Cord blood functions
(A) In general
With respect to cord blood, the Program
shall—
(i) operate a system for identifying,
matching, and facilitating the distribution
of donated cord blood units that are suitably matched to candidate patients and
meet all applicable Federal and State regulations (including informed consent and
Food and Drug Administration regulations) from a qualified cord blood bank;
(ii) consistent with paragraph (3), allow
transplant physicians, other appropriate
health care professionals, and patients to
search by means of electronic access all
available cord blood units made available
through the Program;
(iii) allow transplant physicians and
other appropriate health care professionals
to reserve, as defined by the Secretary, a
cord blood unit for transplantation;
(iv) support and expand new and existing
studies and demonstration and outreach
projects for the purpose of increasing cord
blood unit donation and collection from a
genetically diverse population and expanding the number of cord blood unit collection sites partnering with cord blood
banks receiving a contract under the National Cord Blood Inventory program
under section 2 of the Stem Cell Therapeutic and Research Act of 2005, including
such studies and projects that focus on—
(I) remote collection of cord blood
units, consistent with the requirements
under the Program and the National
Cord Blood Inventory program goal described in section 2(a) of the Stem Cell
Therapeutic and Research Act of 2005;
and
(II) exploring novel approaches or incentives to encourage innovative technological advances that could be used to
collect cord blood units, consistent with
the requirements under the Program and
such National Cord Blood Inventory program goal;
(v) provide for a system of patient advocacy through the office established under
subsection (h) of this section;
(vi) coordinate with the qualified cord
blood banks to support informational and
educational activities in accordance with
subsection (g) of this section;
(vii) maintain and expand medical contingency response capabilities, in coordination with Federal programs, to prepare
for and respond effectively to biological,
chemical, or radiological attacks, and
other public health emergencies that can
damage marrow, so that the capability of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

supporting patients with marrow damage
from disease can be used to support casualties with marrow damage; and
(viii) with respect to the system under
subparagraph (A), collect, analyze, and
publish data in a standardized electronic
format, as required by the Secretary, on
the number and percentage of patients at
each of the various stages of the search
process, including data regarding the furthest stage reached, the number and percentage of patients who are unable to complete the search process, and the reasons
underlying such circumstances.
(B) Efforts to increase collection of high
quality cord blood units
In carrying out subparagraph (A)(iv), not
later than 1 year after October 8, 2010, and
annually thereafter, the Secretary shall set
an annual goal of increasing collections of
high quality cord blood units, consistent
with the inventory goal described in section
2(a) of the Stem Cell Therapeutic and Research Act of 2005 (referred to in this subparagraph as the ‘‘inventory goal’’), and
shall identify at least one project under subparagraph (A)(iv) to replicate and expand nationwide, as appropriate. If the Secretary
cannot identify a project as described in the
preceding sentence, the Secretary shall submit a plan, not later than 180 days after the
date on which the Secretary was required to
identify such a project, to the Committee on
Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy
and Commerce of the House of Representatives for expanding remote collection of high
quality cord blood units, consistent with the
requirements under the National Cord Blood
Inventory program under section 2 of the
Stem Cell Therapeutic and Research Act of
2005 and the inventory goal. Each such plan
shall be made available to the public.
(C) Definition
In this paragraph, the term ‘‘remote collection’’ means the collection of cord blood
units at locations that do not have written
contracts with cord blood banks for collection support.
(3) Single point of access; standard data
(A) Single point of access
The Secretary shall ensure that health
care professionals and patients are able to
search electronically for and facilitate access to, in the manner and to the extent defined by the Secretary and consistent with
the functions described in paragraphs (1)(A)
and (2)(A)(i), cells from bone marrow donors
and cord blood units through a single point
of access.
(B) Standard data
The Secretary shall require all recipients
of contracts under this section to make
available a standard dataset for purposes of
subparagraph (A) in a standardized electronic format that enables transplant physicians to compare among and between bone
marrow donors and cord blood units to ensure the best possible match for the patient.

Page 412

(4) Definition
The term ‘‘qualified cord blood bank’’ means
a cord blood bank that—
(A) has obtained all applicable Federal and
State licenses, certifications, registrations
(including pursuant to the regulations of the
Food and Drug Administration), and other
authorizations required to operate and
maintain a cord blood bank;
(B) has implemented donor screening, cord
blood collection practices, and processing
methods intended to protect the health and
safety of donors and transplant recipients to
improve transplant outcomes, including
with respect to the transmission of potentially harmful infections and other diseases;
(C) is accredited by an accreditation entity
recognized by the Secretary under subsection (b) of this section;
(D) has established a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance
with existing Federal and State law;
(E) has established a system for encouraging donation by a genetically diverse group
of donors; and
(F) has established a system to confidentially maintain linkage between a cord blood
unit and a maternal donor.
(e) Bone marrow recruitment; priorities; information and education
(1) Recruitment; priorities
The Program shall carry out activities for
the recruitment of bone marrow donors. Such
recruitment program shall identify populations that are underrepresented among potential donors enrolled with the Program. In
the case of populations that are identified
under the preceding sentence:
(A) The Program shall give priority to carrying out activities under this part to increase representation for such populations
in order to enable a member of such a population, to the extent practicable, to have a
probability of finding a suitable unrelated
donor that is comparable to the probability
that an individual who is not a member of an
underrepresented population would have.
(B) The Program shall consider racial and
ethnic minority groups (including persons of
mixed ancestry) to be populations that have
been identified for purposes of this paragraph, and shall carry out subparagraph (A)
with respect to such populations.
(2) Information and education regarding recruitment; testing and enrollment
(A) In general
The Program shall carry out informational and educational activities, in coordination with organ donation public awareness
campaigns operated through the Department
of Health and Human Services, for purposes
of recruiting individuals to serve as donors
of bone marrow, and shall test and enroll
with the Program potential bone marrow donors. Such information and educational activities shall include the following:
(i) Making information available to the
general public, including information de-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

scribing the needs of patients with respect
to donors of bone marrow.
(ii) Educating and providing information
to individuals who are willing to serve as
potential bone marrow donors.
(iii) Training individuals in requesting
individuals to serve as potential bone marrow donors.
(B) Priorities
In carrying out informational and educational activities under subparagraph (A),
the Program shall give priority to recruiting
individuals to serve as donors of bone marrow for populations that are identified under
paragraph (1).
(3) Transplantation as treatment option
In addition to activities regarding recruitment, the recruitment program under paragraph (1) shall provide information to physicians, other health care professionals, and the
public regarding bone marrow transplants
from unrelated donors as a treatment option.
(4) Implementation of subsection
The requirements of this subsection shall be
carried out by the entity that has been awarded a contract by the Secretary under subsection (a) of this section to carry out the
functions described in subsection (d)(1) of this
section.
(f) Bone marrow criteria, standards, and procedures
The Secretary shall enforce, for participating
entities, including the Program, individual marrow donor centers, marrow donor registries,
marrow collection centers, and marrow transplant centers—
(1) quality standards and standards for tissue typing, obtaining the informed consent of
donors, and providing patient advocacy;
(2) donor selection criteria, based on established medical criteria, to protect both the
donor and the recipient and to prevent the
transmission of potentially harmful infectious
diseases such as the viruses that cause hepatitis and the etiologic agent for Acquired Immune Deficiency Syndrome;
(3) procedures to ensure the proper collection and transportation of the marrow;
(4) standards for the system for patient advocacy operated under subsection (h) of this
section, including standards requiring the provision of appropriate information (at the start
of the search process and throughout the process) to patients and their families and physicians;
(5) standards that—
(A) require the establishment of a system
of strict confidentiality to protect the identity and privacy of patients and donors in
accordance with Federal and State law; and
(B) prescribe the purposes for which the
records described in subparagraph (A) may
be disclosed, and the circumstances and extent of the disclosure; and
(6) in the case of a marrow donor center or
marrow donor registry participating in the
program, procedures to ensure the establishment of a method for integrating donor files,

§ 274k

searches, and general procedures of the center
or registry with the Program.
(g) Cord blood recruitment; priorities; information and education
(1) Recruitment; priorities
The Program shall support activities, in cooperation with qualified cord blood banks, for
the recruitment of cord blood donors. Such recruitment program shall identify populations
that are underrepresented among cord blood
donors. In the case of populations that are
identified under the preceding sentence:
(A) The Program shall give priority to supporting activities under this part to increase
representation for such populations in order
to enable a member of such a population, to
the extent practicable, to have a probability
of finding a suitable cord blood unit that is
comparable to the probability that an individual who is not a member of an underrepresented population would have.
(B) The Program shall consider racial and
ethnic minority groups (including persons of
mixed ancestry) to be populations that have
been identified for purposes of this paragraph, and shall support activities under
subparagraph (A) with respect to such populations.
(2) Information and education regarding recruitment; testing and donation
(A) In general
In carrying out the recruitment program
under paragraph (1), the Program shall support informational and educational activities in coordination with qualified cord
blood banks and organ donation public
awareness campaigns operated through the
Department of Health and Human Services,
for purposes of recruiting pregnant women
to serve as donors of cord blood. Such information and educational activities shall include the following:
(i) Making information available to the
general public, including information describing the needs of patients with respect
to cord blood units.
(ii) Educating and providing information
to pregnant women who are willing to donate cord blood units.
(iii) Training individuals in requesting
pregnant women to serve as cord blood donors.
(B) Priorities
In carrying out informational and educational activities under subparagraph (A),
the Program shall give priority to supporting the recruitment of pregnant women to
serve as donors of cord blood for populations
that are identified under paragraph (1).
(3) Transplantation as treatment option
In addition to activities regarding recruitment, the recruitment program under paragraph (1) shall provide information to physicians, other health care professionals, and the
public regarding cord blood transplants from
donors as a treatment option.
(4) Implementation of subsection
The requirements of this subsection shall be
carried out by the entity that has been award-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ed a contract by the Secretary under subsection (a) of this section to carry out the
functions described in subsection (d)(2) of this
section.
(h) Patient advocacy and case management for
bone marrow and cord blood
(1) In general
The Secretary shall establish and maintain,
through a contract or other means determined
appropriate by the Secretary, an office of patient advocacy (in this subsection referred to
as the ‘‘Office’’).
(2) General functions
The Office shall meet the following requirements:
(A) The Office shall be headed by a director.
(B) The Office shall be staffed by individuals with expertise in bone marrow and cord
blood therapy covered under the Program.
(C) The Office shall operate a system for
patient advocacy, which shall be separate
from mechanisms for donor advocacy, and
which shall serve patients for whom the Program is conducting, or has been requested to
conduct, a search for a bone marrow donor
or cord blood unit.
(D) In the case of such a patient, the Office
shall serve as an advocate for the patient by
directly providing to the patient (or family
members, physicians, or other individuals
acting on behalf of the patient) individualized services with respect to efficiently utilizing the system under paragraphs (1) and
(2) of subsection (d) of this section to conduct an ongoing search for a bone marrow
donor or cord blood unit and assist with information regarding third party payor matters.
(E) In carrying out subparagraph (D), the
Office shall monitor the system under paragraphs (1) and (2) of subsection (d) of this
section to determine whether the search
needs of the patient involved are being met,
including with respect to the following:
(i) Periodically providing to the patient
(or an individual acting on behalf of the
patient) information regarding bone marrow donors or cord blood units that are
suitably matched to the patient, and other
information regarding the progress being
made in the search.
(ii) Informing the patient (or such other
individual) if the search has been interrupted or discontinued.
(iii) Identifying and resolving problems
in the search, to the extent practicable.
(F) The Office shall ensure that the following data are made available to patients:
(i) The resources available through the
Program.
(ii) A comparison of transplant centers
regarding search and other costs that prior
to transplantation are charged to patients
by transplant centers.
(iii) The post-transplant outcomes for individual transplant centers.
(iv) Information concerning issues that
patients may face after a transplant.

Page 414

(v) Such other information as the Program determines to be appropriate.
(G) The Office shall conduct surveys of patients (or family members, physicians, or
other individuals acting on behalf of patients) to determine the extent of satisfaction with the system for patient advocacy
under this subsection, and to identify ways
in which the system can be improved to best
meet the needs of patients.
(3) Case management
(A) In general
In serving as an advocate for a patient
under paragraph (2), the Office shall provide
individualized case management services directly to the patient (or family members,
physicians, or other individuals acting on
behalf of the patient), including—
(i) individualized case assessment; and
(ii) the functions described in paragraph
(2)(D) (relating to progress in the search
process).
(B) Postsearch functions
In addition to the case management services described in paragraph (1) for patients,
the Office shall, on behalf of patients who
have completed the search for a bone marrow donor or cord blood unit, provide information and education on the process of receiving a transplant, including the posttransplant process.
(i) Comment procedures
The Secretary shall establish and provide information to the public on procedures under
which the Secretary shall receive and consider
comments from interested persons relating to
the manner in which the Program is carrying
out the duties of the Program. The Secretary
may promulgate regulations under this section.
(j) Consultation
In developing policies affecting the Program,
the Secretary shall consult with the Advisory
Council, the Department of Defense Marrow
Donor Recruitment and Research Program operated by the Department of the Navy, and the
board of directors of each entity awarded a contract under this section.
(k) Contracts
(1) Application
To be eligible to enter into a contract under
this section, an entity shall submit to the Secretary and obtain approval of an application
at such time, in such manner, and containing
such information as the Secretary shall by
regulation prescribe.
(2) Considerations
In awarding contracts under this section,
the Secretary shall give consideration to the
continued safety of donors and patients and
other factors deemed appropriate by the Secretary.
(l) Eligibility
Entities eligible to receive a contract under
this section shall include private nonprofit entities.

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(m) Records
(1) Recordkeeping
Each recipient of a contract or subcontract
under subsection (a) of this section shall keep
such records as the Secretary shall prescribe,
including records that fully disclose the
amount and disposition by the recipient of the
proceeds of the contract, the total cost of the
undertaking in connection with which the
contract was made, and the amount of the portion of the cost of the undertaking supplied by
other sources, and such other records as will
facilitate an effective audit.
(2) Examination of records
The Secretary and the Comptroller General
of the United States shall have access to any
books, documents, papers, and records of the
recipient of a contract or subcontract entered
into under this section that are pertinent to
the contract, for the purpose of conducting audits and examinations.
(n) Penalties for disclosure
Any person who discloses the content of any
record referred to in subsection (d)(4)(D) or
(f)(5)(A) of this section without the prior written
consent of the donor or potential donor with respect to whom the record is maintained, or in
violation of the standards described in subsection (f)(5)(B) of this section, shall be imprisoned for not more than 2 years or fined in accordance with title 18, or both.
(July 1, 1944, ch. 373, title III, § 379, as added Pub.
L. 101–616, title I, § 101(a)(2), Nov. 16, 1990, 104
Stat. 3279; amended Pub. L. 105–196, § 2(a), (b)(1),
(c)–(g), July 16, 1998, 112 Stat. 631–635; Pub. L.
109–129, § 3(a), Dec. 20, 2005, 119 Stat. 2553; Pub. L.
111–264, § 2(b), Oct. 8, 2010, 124 Stat. 2791.)
REFERENCES IN TEXT
Section 2 of the Stem Cell Therapeutic and Research
Act of 2005, referred to in subsec. (d)(2)(A)(iv), (B), is
section 2 of Pub. L. 109–129, Dec. 20, 2005, 119 Stat. 2550,
which is set out as a note under this section.
AMENDMENTS
2010—Subsec. (a)(6). Pub. L. 111–264, § 2(b)(1), added
par. (6) and struck out former par. (6) which read as follows: ‘‘The Secretary, acting through the Advisory
Council, shall submit to the Congress—
‘‘(A) an annual report on the activities carried out
under this section; and
‘‘(B) not later than 6 months after December 20,
2005, a report of recommendations on the scientific
factors necessary to define a cord blood unit as a
high-quality unit.’’
Subsec. (d)(2). Pub. L. 111–264, § 2(b)(2)(A), designated
existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (H) as cls. (i) to (viii),
respectively, of subpar. (A), added cl. (iv) and struck
out former cl. (iv) which related to studies and demonstration and outreach projects for the purpose of increasing cord blood donation, and added subpars. (B)
and (C).
Subsec. (d)(3)(A). Pub. L. 111–264, § 2(b)(2)(B), substituted ‘‘(2)(A)(i)’’ for ‘‘(2)(A)’’.
Subsec. (f)(5)(A). Pub. L. 111–264, § 2(b)(3), added subpar. (A) and struck out former subpar. (A) which read
as follows: ‘‘require the establishment of a system of
strict confidentiality of records relating to the identity, address, HLA type, and managing marrow donor
center for marrow donors and potential marrow donors;
and’’.

§ 274k

2005—Pub. L. 109–129 amended section generally, substituting provisions relating to the C.W. Bill Young
Cell Transplantation Program for provisions relating
to the National Bone Marrow Donor Registry.
1998—Subsec. (a). Pub. L. 105–196, § 2(a), substituted
‘‘(referred to in this part as the ‘Registry’) that has the
purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow, and that meets’’ for ‘‘(referred to
in this part as the ‘Registry’) that meets’’ and substituted ‘‘under the direction of a board of directors
meeting the following requirements:’’ and pars. (1) to
(4) for ‘‘under the direction of a board of directors that
shall include representatives of marrow donor centers,
marrow transplant centers, persons with expertise in
the social science, and the general public.’’
Subsec. (b)(2) to (8). Pub. L. 105–196, § 2(b)(1), added
pars. (2) to (7), redesignated former par. (7) as (8), and
struck out former pars. (2) to (6) which read as follows:
‘‘(2) establish a system for patient advocacy, separate
from mechanisms for donor advocacy, that directly assists patients, their families, and their physicians in
the search for an unrelated marrow donor;
‘‘(3) increase the representation of individuals from
racial and ethnic minority groups in the pool of potential donors for the Registry in order to enable an individual in a minority group, to the extent practicable,
to have a comparable chance of finding a suitable unrelated donor as would an individual not in a minority
group;
‘‘(4) provide information to physicians, other health
care professionals, and the public regarding bone marrow transplantation;
‘‘(5) recruit potential bone marrow donors;
‘‘(6) collect, analyze, and publish data concerning
bone marrow donation and transplantation; and’’.
Subsecs. (c), (d). Pub. L. 105–196, § 2(c), (d), added subsecs. (c) and (d). Former subsecs. (c) and (d) redesignated (e) and (f), respectively.
Subsec. (e). Pub. L. 105–196, § 2(c), redesignated subsec.
(c) as (e). Former subsec. (e) redesignated (g).
Subsec. (e)(4). Pub. L. 105–196, § 2(e), added par. (4) and
struck out former par. (4) which read as follows:
‘‘standards that require the provision of information to
patients, their families, and their physicians at the
start of the search process concerning—
‘‘(A) the resources available through the Registry;
‘‘(B) all other marrow donor registries meeting the
standards described in this paragraph; and
‘‘(C) in the case of the Registry—
‘‘(i) the comparative costs of all charges by marrow transplant centers incurred by patients prior to
transplantation; and
‘‘(ii) the success rates of individual marrow transplant centers;’’.
Subsec. (f). Pub. L. 105–196, § 2(c), (g)(1), redesignated
subsec. (d) as (f) and substituted ‘‘subsection (e)’’ for
‘‘subsection (c)’’. Former subsec. (f) redesignated (h).
Subsecs. (g) to (i). Pub. L. 105–196, § 2(c), redesignated
subsecs. (e) to (g) as (g) to (i), respectively. Former subsecs. (h) and (i) redesignated (j) and (k), respectively.
Subsec. (j). Pub. L. 105–196, § 2(c), redesignated subsec.
(h) as (j) and struck out heading and text of former subsec. (j). Text read as follows: ‘‘There are authorized to
be appropriated to carry out this section $15,000,000 for
fiscal year 1991 and such sums as may be necessary for
each of fiscal years 1992 and 1993.’’
Subsec. (k). Pub. L. 105–196, § 2(c), (g)(2), redesignated
subsec. (i) as (k) and substituted ‘‘subsection (e)(5)(A)’’
for ‘‘subsection (c)(5)(A)’’ and ‘‘subsection (e)(5)(B)’’ for
‘‘subsection (c)(5)(B)’’.
Subsec. (l). Pub. L. 105–196, § 2(f), added subsec. (l).
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–196, § 7, July 16, 1998, 112 Stat. 637, provided that: ‘‘This Act [see Short Title of 1998 Amendment note set out under section 201 of this title] takes
effect October 1, 1998, or upon the date of the enactment of this Act [July 16, 1998], whichever occurs
later.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
SAVINGS PROVISION

Section 102 of title I of Pub. L. 101–616 provided that:
‘‘(a) IN GENERAL.—This title [enacting this section
and section 274l of this title and amending section 274a
of this title], and the amendments made by this title,
shall not affect any legal document, including any
order, regulation, grant, or contract, in effect on the
date of enactment of this Act [Nov. 16, 1990], or any administrative proceeding or lawsuit pending on the date,
that relates to the bone marrow registry established
under section 373(b) of the Public Health Service Act
[section 274a(b) of this title] (as it existed before the
amendment made by section 101(b) of this Act).
‘‘(b) CONTINUED EFFECT.—A legal document described
in subsection (a) or an order issued in a lawsuit described in subsection (a) shall continue in effect until
modified, terminated, or revoked.
‘‘(c) PROCEEDINGS.—In any administrative proceeding
or lawsuit described in subsection (a), parties shall
take appeals, and officials shall hold proceedings and
render judgments, in the same manner and with the
same effect as if this title had not been enacted.’’
CORD BLOOD INVENTORY
Pub. L. 109–129, § 2, Dec. 20, 2005, 119 Stat. 2550, as
amended by Pub. L. 111–264, § 2(a), Oct. 8, 2010, 124 Stat.
2789, provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services shall enter into one-time contracts
with qualified cord blood banks to assist in the collection and maintenance of the inventory goal of at least
150,000 new units of high-quality cord blood to be made
available for transplantation through the C.W. Bill
Young Cell Transplantation Program and to carry out
the requirements of subsection (b).
‘‘(b) REQUIREMENTS.—The Secretary shall require
each recipient of a contract under this section—
‘‘(1) to acquire, tissue-type, test, cryopreserve, and
store donated units of cord blood acquired with the
informed consent of the donor, as determined by the
Secretary pursuant to section 379(c) of the Public
Health Service Act [subsec. (c) of this section], in a
manner that complies with applicable Federal and
State regulations;
‘‘(2) to encourage donation from a genetically diverse population;
‘‘(3) to make cord blood units that are collected
pursuant to this section or otherwise and meet all applicable Federal standards available to transplant
centers for transplantation;
‘‘(4) to make cord blood units that are collected,
but not appropriate for clinical use, available for
peer-reviewed research;
‘‘(5) to make data available, as required by the Secretary and consistent with section 379(d)(3) of the
Public Health Service Act (42 U.S.C. 274k(d)(3)), as
amended by this Act, in a standardized electronic format, as determined by the Secretary, for the C.W.
Bill Young Cell Transplantation Program; and
‘‘(6) to submit data in a standardized electronic format for inclusion in the stem cell therapeutic outcomes database maintained under section 379A of the
Public Health Service Act [section 274l of this title],
as amended by this Act.
‘‘(c) RELATED CORD BLOOD DONORS.—
‘‘(1) IN GENERAL.—The Secretary shall establish a 3year demonstration project under which qualified
cord blood banks receiving a contract under this section may use a portion of the funding under such contract for the collection and storage of cord blood
units for a family where a first-degree relative has
been diagnosed with a condition that will benefit
from transplantation (including selected blood disorders, malignancies, metabolic storage disorders,
hemoglobinopathies,
and
congenital
immunodeficiencies) at no cost to such family. Qualified cord blood banks collecting cord blood units
under this paragraph shall comply with the requirements of paragraphs (1), (2), (3), and (5) of subsection
(b).

Page 416

‘‘(2) AVAILABILITY.—Qualified cord blood banks that
are operating a program under paragraph (1) shall
provide assurances that the cord blood units in such
banks will be available for directed transplantation
until such time that the cord blood unit is released
for transplantation for a first-degree relative.
‘‘(3) INVENTORY.—Cord blood units collected
through the program under this section shall not be
counted toward the inventory goal under the C.W.
Bill Young Cell Transplantation Program.
‘‘(4) REPORT.—Not later than 90 days after the date
on which the project under paragraph (1) is terminated by the Secretary, the Secretary shall submit to
Congress a report on the outcomes of the project that
shall include the recommendations of the Secretary
with respect to the continuation of such project.
‘‘(d) APPLICATION.—To seek to enter into a contract
under this section, a qualified cord blood bank shall
submit an application to the Secretary at such time, in
such manner, and containing such information as the
Secretary may reasonably require. At a minimum, an
application for a contract under this section shall include a requirement that the applicant—
‘‘(1) will participate in the C.W. Bill Young Cell
Transplantation Program for a period of at least 10
years beginning on the last date on which the recipient of a contract under this section receives Federal
funds under this section;
‘‘(2) will make cord blood units collected pursuant
to this section available through the C.W. Bill Young
Cell Transplantation Program in perpetuity or for
such time as determined viable by the Secretary;
‘‘(3) will provide a plan to increase cord blood unit
collections at collection sites that exist at the time
of application, assist with the establishment of new
collection sites, or contract with new collection sites;
‘‘(4) will annually provide to the Secretary a plan
for, and demonstrate, ongoing measurable progress
toward achieving self-sufficiency of cord blood unit
collection and banking operations; and
‘‘(5) if the Secretary determines through an assessment, or through petition by the applicant, that a
cord blood bank is no longer operational or does not
meet the requirements of section 379(d)(4) of the Public Health Service Act [subsec. (d)(4) of this section]
(as added by this Act) and as a result may not distribute the units, transfer the units collected pursuant to
this section to another qualified cord blood bank approved by the Secretary to ensure continued availability of cord blood units.
‘‘(e) DURATION OF CONTRACTS.—
‘‘(1) IN GENERAL.—Except as provided in paragraph
(2), the term of each contract entered into by the Secretary under this section shall be for a period of at
least 10 years beginning on the last date on which the
recipient of a contract under this section receives
Federal funds under this section. The Secretary shall
ensure that no Federal funds shall be obligated under
any such contract after the date that is 5 years after
the date on which the contract is entered into, except
as provided in paragraphs (2) and (3).
‘‘(2) EXTENSIONS.—The Secretary may extend the
period of funding under a contract under this section
to exceed a period of 5 years if—
‘‘(A) the Secretary finds that the inventory goal
described in subsection (a) has not yet been met;
‘‘(B) the Secretary does not receive an application
for a contract under this section meeting the requirements under subsection (d) from any qualified
cord blood bank that has not previously entered
into a contract under this section; or
‘‘(C) the Secretary determines that the outstanding inventory need cannot be met by the qualified
cord blood banks under contract under this section.
‘‘(3) EXTENSION ELIGIBILITY.—A qualified cord blood
bank shall be eligible for a 5-year extension of a contract awarded under this section, as described in
paragraph (2), provided that the qualified cord blood
bank—
‘‘(A) demonstrates a superior ability to satisfy
the requirements described in subsection (b) and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

achieves the overall goals for which the contract
was awarded;
‘‘(B) provides a plan for how the qualified cord
blood bank will increase cord blood unit collections
at collection sites that exist at the time of consideration for such extension of a contract, assist with
the establishment of new collection sites, or contract with new collection sites; and
‘‘(C) annually provides to the Secretary a plan
for, and demonstrates, ongoing measurable progress
toward achieving self-sufficiency of cord blood unit
collection and banking operations.
‘‘(f) REGULATIONS.—The Secretary may promulgate
regulations to carry out this section.
‘‘(g) DEFINITIONS.—In this section:
‘‘(1) The term ‘C.W. Bill Young Cell Transplantation Program’ means the C.W. Bill Young Cell
Transplantation Program under section 379 of the
Public Health Service Act [this section], as amended
by this Act.
‘‘(2) The term ‘cord blood donor’ means a mother
who has delivered a baby and consents to donate the
neonatal blood remaining in the placenta and umbilical cord after separation from the newborn baby.
‘‘(3) The term ‘cord blood unit’ means the neonatal
blood collected from the placenta and umbilical cord
of a single newborn baby.
‘‘(4) The term ‘first-degree relative’ means a sibling
who is one meiosis away from a particular individual
in a family.
‘‘(5) The term ‘qualified cord blood bank’ has the
meaning given to that term in section 379(d)(4) of the
Public Health Service Act [subsec. (d)(4) of this section], as amended by this Act.
‘‘(6) The term ‘Secretary’ means the Secretary of
Health and Human Services.
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to the Secretary to
carry out the program under this section $23,000,000
for each of fiscal years 2011 through 2014 and
$20,000,000 for fiscal year 2015.
‘‘(2) LIMITATION.—Not to exceed 5 percent of the
amount appropriated under this section for each of
fiscal years 2011 through 2015 may be used to carry
out the demonstration project under subsection (c).’’
REPORT OF INSPECTOR GENERAL; PLAN REGARDING
RELATIONSHIP BETWEEN REGISTRY AND DONOR CENTERS
Pub. L. 105–196, § 2(b)(2), July 16, 1998, 112 Stat. 632, directed the Secretary of Health and Human Services to
ensure that, not later than 1 year after July 16, 1998,
the National Bone Marrow Donor Registry (under this
section) developed, evaluated, and implemented a plan
to effectuate efficiencies in the relationship between
such Registry and donor centers.
STUDY BY GAO
Pub. L. 105–196, § 5, July 16, 1998, 112 Stat. 636, provided that the Comptroller General was to conduct a
study of the National Bone Marrow Donor Registry
under this section to determine the extent to which the
Registry had increased the representation of racial and
ethnic minority groups among potential donors enrolled with the Registry and whether the extent of increase resulted in a level of representation that met
the standard established in subsec. (c)(1)(A) of this section, the extent to which patients in need of a transplant of bone marrow from a biologically unrelated
donor, and the physicians of such patients, had been
utilizing the Registry, the number of patients for whom
the Registry began a preliminary but not complete
search process and the reasons underlying such circumstances, the extent to which the plan required in section 2(b)(2) of Pub. L. 105–196 (42 U.S.C. 274k note) had
been implemented, and the extent to which the Registry, donor centers, donor registries, collection centers, transplant centers, and other appropriate entities
had been complying with subsec. (e) of this section; and

§ 274l

provided that a report describing the findings of this
study was to be submitted to Congress not later than
Oct. 1, 2001, and not before Jan. 1, 2001.
COMPLIANCE WITH NEW REQUIREMENTS FOR OFFICE OF
PATIENT ADVOCACY
Pub. L. 105–196, § 6, July 16, 1998, 112 Stat. 636, provided that with respect to requirements for the office of
patient advocacy under subsec. (d) of this section, the
Secretary of Health and Human Services was to ensure
that, not later than 180 days after Oct. 1, 1998, such office was in compliance with all requirements that were
additional to the requirements under this section in effect with respect to patient advocacy on the day before
July 16, 1998.

§ 274l. Stem cell therapeutic outcomes database
(a) Establishment
The Secretary shall by contract establish and
maintain a scientific database of information
relating to patients who have been recipients of
a stem cell therapeutics product (including bone
marrow, cord blood, or other such product) from
a donor.
(b) Information
The outcomes database shall include information in a standardized electronic format with respect to patients described in subsection (a) of
this section, diagnosis, transplant procedures,
results, long-term follow-up, and such other information as the Secretary determines to be appropriate, to conduct an ongoing evaluation of
the scientific and clinical status of transplantation involving recipients of a stem cell therapeutics product from a donor.
(c) Annual report on patient outcomes
The Secretary shall require the entity awarded a contract under this section to submit to the
Secretary an annual report concerning patient
outcomes with respect to each transplant center, based on data collected and maintained by
the entity pursuant to this section.
(d) Publicly available data
The outcomes database shall make relevant
scientific information not containing individually identifiable information available to the
public in the form of summaries and data sets to
encourage medical research and to provide information to transplant programs, physicians, patients, entities awarded a contract under section
274k of this title 1 donor registries, and cord
blood banks.
(July 1, 1944, ch. 373, title III, § 379A, as added
Pub. L. 105–196, § 3, July 16, 1998, 112 Stat. 635;
amended Pub. L. 109–129, § 3(b), Dec. 20, 2005, 119
Stat. 2561.)
PRIOR PROVISIONS
A prior section 274l, act July 1, 1944, ch. 373, title III,
§ 379A, as added Pub. L. 101–616, title I, § 101(a)(2), Nov.
16, 1990, 104 Stat. 3282, related to study by General Accounting Office, prior to repeal by Pub. L. 105–196, §§ 3,
7, July 16, 1998, 112 Stat. 635, 637, effective Oct. 1, 1998.
AMENDMENTS
2005—Pub. L. 109–129, amended section generally, substituting provisions relating to the stem cell therapeutic outcomes database for provisions relating to the
bone marrow scientific registry.
1 So

in original. Probably should be followed by a comma.

§ 274l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section effective Oct. 1, 1998, see section 7 of Pub. L.
105–196, set out as an Effective Date of 1998 Amendment
note under section 274k of this title.

§ 274l–1. Definitions
In this part:
(1) The term ‘‘Advisory Council’’ means the
advisory council established by the Secretary
under section 274k(a)(1) of this title.
(2) The term ‘‘bone marrow’’ means the cells
found in adult bone marrow and peripheral
blood.
(3) The term ‘‘outcomes database’’ means
the database established by the Secretary
under section 274l of this title.
(4) The term ‘‘Program’’ means the C.W. Bill
Young Cell Transplantation Program established under section 274k of this title.
(July 1, 1944, ch. 373, title III, § 379A–1, as added
Pub. L. 109–129, § 3(c), Dec. 20, 2005, 119 Stat.
2562.)
§ 274m. Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated
$30,000,000 for each of fiscal years 2011 through
2014 and $33,000,000 for fiscal year 2015.
(July 1, 1944, ch. 373, title III, § 379B, as added
Pub. L. 105–196, § 4(2), July 16, 1998, 112 Stat. 636;
amended Pub. L. 109–129, § 3(d), Dec. 20, 2005, 119
Stat. 2562; Pub. L. 111–264, § 2(d), Oct. 8, 2010, 124
Stat. 2792.)
AMENDMENTS
2010—Pub. L. 111–264 substituted ‘‘$30,000,000 for each
of fiscal years 2011 through 2014 and $33,000,000 for fiscal
year 2015.’’ for ‘‘$34,000,000 for fiscal year 2006 and
$38,000,000 for each of fiscal years 2007 through 2010.’’
2005—Pub. L. 109–129 amended section generally. Prior
to amendment, section read as follows: ‘‘For the purpose of carrying out this part, there are authorized to
be appropriated $18,000,000 for fiscal year 1999, and such
sums as may be necessary for each of the fiscal years
2000 through 2003.’’
EFFECTIVE DATE
Section effective Oct. 1, 1998, see section 7 of Pub. L.
105–196, set out as an Effective Date of 1998 Amendment
note under section 274k of this title.

§ 275. Repealed. Pub. L. 103–43, title I, § 121(a),
June 10, 1993, 107 Stat. 133
Section, act July 1, 1944, ch. 373, title III, § 381, as
added Nov. 20, 1985, Pub. L. 99–158, § 11, 99 Stat. 883;
amended Nov. 4, 1988, Pub. L. 100–607, title I, § 157(a), 102
Stat. 3059, established the Biomedical Ethics Board and
provided for its membership, functions, reports to Congress, etc., and provided for appointment of a Biomedical Ethics Advisory Committee to assist the Biomedical Ethics Board.
A prior section 275, act July 1, 1944, ch. 373, title III,
§ 381, formerly § 371, as added Aug. 3, 1956, ch. 907, § 1, 70
Stat. 960; renumbered § 381, Mar. 13, 1970, Pub. L. 91–212,
§ 10(a)(3), 84 Stat. 66, established a National Library of
Medicine in the Public Health Service and stated the
congressional purposes for such establishment, prior to
repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.

§§ 276 to 280a–1. Repealed. Pub. L. 99–158, § 3(b),
Nov. 20, 1985, 99 Stat. 879
Section 276, act July 1, 1944, ch. 373, title III, § 382, formerly § 372, as added Aug. 3, 1956, ch. 907, § 1, 70 Stat.

Page 418

960; renumbered § 382 and amended Mar. 13, 1970, Pub. L.
91–212, § 10(a)(3), (b)(1), (d)(1), 84 Stat. 66, 67; Nov. 18,
1971, Pub. L. 92–157, title III, § 301(d)(1), 85 Stat. 463, related to functions of Secretary with regard to acquisition, etc., of materials and rules for public access to
materials.
Section 277, act July 1, 1944, ch. 373, title III, § 383, formerly § 373, as added Aug. 3, 1956, ch. 907, § 1, 70 Stat.
960; amended Oct. 22, 1965, Pub. L. 89–291, § 4, 79 Stat.
1067; renumbered § 383 and amended Mar. 13, 1970, Pub.
L. 91–212, § 10(a)(3), (d)(1), 84 Stat. 66, 67; Oct. 30, 1970,
Pub. L. 91–515, title VI, § 601(b)(2), 84 Stat. 1311; Nov. 18,
1971, Pub. L. 92–157, title III, § 301(d)(2), 85 Stat. 464; Nov.
9, 1978, Pub. L. 95–622, title II, § 212, 92 Stat. 3421, related
to establishment, etc., of Board of Regents.
Section 278, act July 1, 1944, ch. 373, title III, § 384, formerly § 374, as added Aug. 3, 1956, ch. 907, § 1, 70 Stat.
961; renumbered § 384 and amended Mar. 13, 1970, Pub. L.
91–212, § 10(a)(3), (d)(1), 84 Stat. 66, 67; Oct. 17, 1979, Pub.
L. 96–88, title V, § 509(b), 93 Stat. 695; Apr. 26, 1983, Pub.
L. 98–24, § 2(a)(2), 97 Stat. 176, related to acceptance and
administration of gifts and establishment of memorials
to donors.
Section 279, act July 1, 1944, ch. 373, title III, § 385, formerly § 375, as added Aug. 3, 1956, ch. 907 § 1, 70 Stat. 962;
renumbered § 385 and amended Mar. 13, 1970, Pub. L.
91–212, § 10(a)(3), (b)(2), 84 Stat. 66, defined ‘‘medicine’’
and ‘‘medical’’.
Section 280, act July 1, 1944, ch. 373, title III, § 386, formerly § 376, as added Aug. 3, 1956, ch. 907, § 1, 70 Stat.
962; renumbered § 386 and amended Mar. 13, 1970, Pub. L.
91–212, § 10(a)(3), (d)(1), 84 Stat. 66, 67; Nov. 18, 1971, Pub.
L. 92–157, title III, § 301(d)(3), 85 Stat. 464, authorized appropriations for erection and equipment of Library.
Section 280a, act July 1, 1944, ch. 373, title III, § 387,
formerly § 377, as added Aug. 3, 1956, ch. 907, § 1, 70 Stat.
962; amended 1970 Reorg. Plan No. 2 § 102, eff. July 1,
1970, 35 F.R. 7959, 84 Stat. 2085; renumbered § 387, Mar.
13, 1970, Pub. L. 91–212, § 10(a)(3), 84 Stat. 66, related to
transfer of Armed Forces Medical Library to Public
Health Service for use in administration of part I.
Section 280a–1, act July 1, 1944, ch. 373, title III, § 388,
formerly § 378, as added Oct. 22, 1965, Pub. L. 89–291, § 3,
79 Stat. 1067; renumbered § 388 and amended Mar. 13,
1970, Pub. L. 91–212, § 10(a)(3), (d)(1), 84 Stat. 66, 67; Nov.
18, 1971, Pub. L. 92–157, title III, § 301(d)(4), 85 Stat. 464,
related to establishment of regional branches.

PART J—PREVENTION AND CONTROL OF INJURIES
AMENDMENTS
1993—Pub. L. 103–183, title II, § 203(a)(1), Dec. 14, 1993,
107 Stat. 2232, substituted ‘‘Prevention and Control of
Injuries’’ for ‘‘Injury Control’’ in part heading.
Pub. L. 103–43, title XX, § 2008(i)(2)(B)(i), June 10, 1993,
107 Stat. 213, redesignated part K ‘‘Injury Control’’ as J.
Former part J ‘‘Biomedical Ethics’’, consisting of section 275, was repealed by Pub. L. 103–43, title I, § 121(a),
June 10, 1993, 107 Stat. 133.
1990—Pub. L. 101–616, title I, § 101(a)(1), Nov. 16, 1990,
104 Stat. 3279, redesignated part I ‘‘Biomedical Ethics’’
as J. Former part J ‘‘Injury Control’’ redesignated K.

§ 280b. Research
(a) The Secretary, through the Director of the
Centers for Disease Control and Prevention,
shall—
(1) conduct, and give assistance to public
and nonprofit private entities, scientific institutions, and individuals engaged in the conduct of, research relating to the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries;
(2) make grants to, or enter into cooperative
agreements or contracts with, public and nonprofit private entities (including academic institutions, hospitals, and laboratories) and individuals for the conduct of such research; and

Page 419

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) make grants to, or enter into cooperative
agreements or contracts with, academic institutions for the purpose of providing training
on the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation
from injuries.
(b) The Secretary, through the Director of the
Centers for Disease Control and Prevention,
shall collect and disseminate, through publications and other appropriate means, information
concerning the practical applications of research conducted or assisted under subsection
(a) of this section. In carrying out the preceding
sentence, the Secretary shall disseminate such
information to the public, including through
elementary and secondary schools.
(July 1, 1944, ch. 373, title III, § 391, as added Pub.
L. 99–649, § 3, Nov. 10, 1986, 100 Stat. 3633; amended Pub. L. 101–558, § 2(a), Nov. 15, 1990, 104 Stat.
2772; Pub. L. 102–531, title III, § 312(d)(3), Oct. 27,
1992, 106 Stat. 3504; Pub. L. 103–183, title II,
§ 203(b)(2), Dec. 14, 1993, 107 Stat. 2232.)
PRIOR PROVISIONS
A prior section 280b, act July 1, 1944, ch. 373, title III,
§ 390, as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79 Stat.
1059; amended Mar. 13, 1970, Pub. L. 91–212, §§ 4(b), 5(b),
6(b), 84 Stat. 64, 65; July 23, 1974, Pub. L. 93–353, title II,
§§ 201(a), (b), 202(a), 88 Stat. 371, 372; Aug. 1, 1977, Pub. L.
95–83, title II, § 202, 91 Stat. 386; Nov. 9, 1978, Pub. L.
95–622, title II, § 211, 92 Stat. 3420; Aug. 13, 1981, Pub. L.
97–35, title IX, § 925(a), 95 Stat. 569, set forth findings
and declaration of policy and authorized appropriations
with regard to assistance to medical libraries, prior to
repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
A prior section 391 of act July 1, 1944, ch. 373, title III,
as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79 Stat. 1059;
amended Mar. 13, 1970, Pub. L. 91–212, § 10(b)(3), 84 Stat.
66; July 23, 1974, Pub. L. 93–353, title II, § 202(b), 88 Stat.
372, which defined ‘‘sciences related to health’’, ‘‘National Medical Libraries Assistance Advisory Board’’,
‘‘Board’’, and ‘‘medical library’’, was classified to section 280b–1 of this title, prior to repeal by Pub. L.
99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
AMENDMENTS
1993—Subsec. (b). Pub. L. 103–183 inserted at end ‘‘In
carrying out the preceding sentence, the Secretary
shall disseminate such information to the public, including through elementary and secondary schools.’’
1992—Pub. L. 102–531 substituted ‘‘Centers for Disease
Control and Prevention’’ for ‘‘Centers for Disease Control’’ in subsecs. (a) and (b).
1990—Subsec. (a)(2). Pub. L. 101–558, § 2(a)(1), inserted
‘‘, or enter into cooperative agreements or contracts
with,’’ after ‘‘grants to’’.
Subsec. (a)(3). Pub. L. 101–558, § 2(a)(2), added par. (3).
FINDINGS AND PURPOSES
Section 2 of Pub. L. 99–649 provided that:
‘‘(a) The Congress finds and declares that:
‘‘(1) Injury is one of the principal public health
problems in America, and causes over 140,000 deaths
per year.
‘‘(2) Injury rates are particularly high for children
and the elderly.
‘‘(3) Injury causes 50 percent of all deaths for children over the age of one year and two-thirds of all
deaths for children over the age of 15 years, and is the
leading cause of death for individuals under the age
of 44 years. Individuals over the age of 65 years have
the highest fatality rates for many injuries.
‘‘(4) Injury control has not been given high priority
in the United States, and the research being conducted on injury control and the number of personnel

§ 280b–1

involved in injury control activities are not adequate.
‘‘(b) The purposes of this Act [enacting this part]
are—
‘‘(1) to promote research into the causes, diagnosis,
treatment, prevention, and control of injuries and rehabilitation from injuries;
‘‘(2) to promote cooperation between specialists in
fields involved in injury research; and
‘‘(3) to promote coordination between Federal,
State, and local governments and public and private
entities in order to achieve a reduction in deaths
from injuries.’’

§ 280b–1. Prevention and control activities
(a) The Secretary, through the Director of the
Centers for Disease Control and Prevention,
shall—
(1) assist States and political subdivisions of
States in activities for the prevention and
control of injuries; and
(2) encourage regional activities between
States designed to reduce injury rates.
(b) The Secretary, through the Director of the
Centers for Disease Control and Prevention,
may—
(1) enter into agreements between the Service and public and private community health
agencies which provide for cooperative planning of activities to deal with problems relating to the prevention and control of injuries;
(2) work in cooperation with other Federal
agencies, and with public and nonprofit private entities, to promote activities regarding
the prevention and control of injuries; and
(3) make grants to States and, after consultation with State health agencies, to other
public or nonprofit private entities for the
purpose of carrying out demonstration
projects for the prevention and control of injuries at sites that are not subject to the Occupational Safety and Health Act of 1970 [29
U.S.C. 651 et seq.], including homes, elementary and secondary schools, and public buildings.
(July 1, 1944, ch. 373, title III, § 392, as added Pub.
L. 99–649, § 3, Nov. 10, 1986, 100 Stat. 3634; amended Pub. L. 101–558, § 2(b), Nov. 15, 1990, 104 Stat.
2772; Pub. L. 102–531, title III, §§ 301, 312(d)(4),
Oct. 27, 1992, 106 Stat. 3482, 3504; Pub. L. 103–183,
title II, § 203(a)(2), (b)(1), Dec. 14, 1993, 107 Stat.
2232.)
REFERENCES IN TEXT
The Occupational Safety and Health Act of 1970, referred to in subsec. (b)(3), is Pub. L. 91–596, Dec. 29, 1970,
84 Stat. 1590, as amended, which is classified principally
to chapter 15 (§ 651 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see Short
Title note set out under section 651 of Title 29 and
Tables.
PRIOR PROVISIONS
A prior section 280b–1, act July 1, 1944, ch. 373, title
III, § 391, as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79
Stat. 1059; amended Mar. 13, 1970, Pub. L. 91–212,
§ 10(b)(3), 84 Stat. 66; July 23, 1974, Pub. L. 93–353, title
II, § 202(b), 88 Stat. 372, defined ‘‘sciences related to
health’’, ‘‘National Medical Libraries Assistance Advisory Board’’, ‘‘Board’’, and ‘‘medical library’’, prior to
repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
A prior section 392 of act July 1, 1944, ch. 373, title III,
as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79 Stat. 1060;

§ 280b–1a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amended Mar. 13, 1970, Pub. L. 91–212, § 10(b)(4), (d)(2)(A),
84 Stat. 66, 67; July 23, 1974, Pub. L. 93–353, title II,
§ 202(c), 88 Stat. 372, which related to composition, functions, etc., of the National Medical Libraries Assistance Advisory Board, was classified to section 280b–2 of
this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov.
20, 1985, 99 Stat. 879.
AMENDMENTS
1993—Pub. L. 103–183, § 203(a)(2)(A), substituted ‘‘Prevention and control activities’’ for ‘‘Control activities’’
in section catchline.
Subsec. (a)(1). Pub. L. 103–183, § 203(a)(2)(B), inserted
‘‘and control’’ after ‘‘prevention’’.
Subsec. (b)(1). Pub. L. 103–183, § 203(a)(2)(C), substituted ‘‘the prevention and control of injuries’’ for
‘‘injuries and injury control’’.
Subsec. (b)(2). Pub. L. 103–183, § 203(b)(1), substituted
‘‘to promote activities regarding the prevention and
control of injuries; and’’ for ‘‘to promote injury control. In carrying out the preceding sentence, the Secretary shall disseminate such information to the public, including through elementary and secondary
schools; and’’.
1992—Pub. L. 102–531, § 312(d)(4), substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’ in introductory provisions of subsecs.
(a) and (b).
Subsec. (b)(1). Pub. L. 102–531, § 301(1), struck out
‘‘and’’ after semicolon at end.
Subsec. (b)(2). Pub. L. 102–531, § 301(2), inserted sentence requiring Secretary to disseminate information
on injury control to the public, including through elementary and secondary schools and substituted ‘‘; and’’
for period at end.
Subsec. (b)(3). Pub. L. 102–531, § 301(3), added par. (3).
1990—Subsec. (b)(2). Pub. L. 101–558 amended par. (2)
generally. Prior to amendment, par. (2) read as follows:
‘‘work in cooperation with Federal, State, and local
agencies to promote injury control.’’

§ 280b–1a. Interpersonal violence within families
and among acquaintances
(a) With respect to activities that are authorized in sections 280b and 280b–1 of this title, the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention,
shall carry out such activities with respect to
interpersonal violence within families and
among acquaintances. Activities authorized in
the preceding sentence include the following:
(1) Collecting data relating to the incidence
of such violence.
(2) Making grants to public and nonprofit
private entities for the evaluation of programs
whose purpose is to prevent such violence, including the evaluation of demonstration
projects under paragraph (6).
(3) Making grants to public and nonprofit
private entities for the conduct of research on
identifying effective strategies for preventing
such violence.
(4) Providing to the public information and
education on such violence, including information and education to increase awareness of
the public health consequences of such violence.
(5) Training health care providers as follows:
(A) To identify individuals whose medical
conditions or statements indicate that the
individuals are victims of such violence.
(B) To routinely determine, in examining
patients, whether the medical conditions or
statements of the patients so indicate.
(C) To refer individuals so identified to entities that provide services regarding such

Page 420

violence, including referrals for counseling,
housing, legal services, and services of community organizations.
(6) Making grants to public and nonprofit
private entities for demonstration projects
with respect to such violence, including with
respect to prevention.
(b) For purposes of this part, the term ‘‘interpersonal violence within families and among acquaintances’’ includes behavior commonly referred to as domestic violence, sexual assault,
spousal abuse, woman battering, partner abuse,
elder abuse, and acquaintance rape.
(July 1, 1944, ch. 373, title III, § 393, as added Pub.
L. 103–183, title II, § 201(2), Dec. 14, 1993, 107 Stat.
2231.)
PRIOR PROVISIONS
A prior section 393 of act July 1, 1944, was renumbered
section 394 and is classified to section 280b–2 of this
title.
Another prior section 393 of act July 1, 1944, was renumbered section 394 and was classified to section
280b–4 of this title.

§ 280b–1b. Use of allotments for rape prevention
education
(a) Permitted use
The Secretary, acting through the National
Center for Injury Prevention and Control at the
Centers for Disease Control and Prevention,
shall award targeted grants to States to be used
for rape prevention and education programs conducted by rape crisis centers, State sexual assault coalitions, and other public and private
nonprofit entities for—
(1) educational seminars;
(2) the operation of hotlines;
(3) training programs for professionals;
(4) the preparation of informational material;
(5) education and training programs for students and campus personnel designed to reduce the incidence of sexual assault at colleges and universities;
(6) education to increase awareness about
drugs used to facilitate rapes or sexual assaults; and
(7) other efforts to increase awareness of the
facts about, or to help prevent, sexual assault,
including efforts to increase awareness in underserved communities and awareness among
individuals with disabilities (as defined in section 12102 of this title).
(b) Collection and dissemination of information
on sexual assault
The Secretary shall, through the National Resource Center on Sexual Assault established
under the National Center for Injury Prevention
and Control at the Centers for Disease Control
and Prevention, provide resource information,
policy, training, and technical assistance to
Federal, State, local, and Indian tribal agencies,
as well as to State sexual assault coalitions and
local sexual assault programs and to other professionals and interested parties on issues relating to sexual assault, including maintenance of
a central resource library in order to collect,
prepare, analyze, and disseminate information

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§ 280b–1c

and statistics and analyses thereof relating to
the incidence and prevention of sexual assault.
(c) Authorization of appropriations
(1) In general
There is authorized to be appropriated to
carry out this section $80,000,000 for each of
fiscal years 2007 through 2011.
(2) National sexual violence resource center allotment
Of the total amount made available under
this subsection in each fiscal year, not less
than $1,500,000 shall be available for allotment
under subsection (b) of this section.
(d) Limitations
(1) Supplement not supplant
Amounts provided to States under this section shall be used to supplement and not supplant other Federal, State, and local public
funds expended to provide services of the type
described in subsection (a) of this section.
(2) Studies
A State may not use more than 2 percent of
the amount received by the State under this
section for each fiscal year for surveillance
studies or prevalence studies.
(3) Administration
A State may not use more than 5 percent of
the amount received by the State under this
section for each fiscal year for administrative
expenses.

may carry out projects to reduce the incidence
of traumatic brain injury. Such projects may be
carried out by the Secretary directly or through
awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such awards provide technical
assistance with respect to the planning, development, and operation of such projects.
(b) Certain activities
Activities under subsection (a) of this section
may include—
(1) the conduct of research into identifying
effective strategies for the prevention of traumatic brain injury;
(2) the implementation of public information
and education programs for the prevention of
such injury and for broadening the awareness
of the public concerning the public health consequences of such injury; and
(3) the implementation of a national education and awareness campaign regarding such
injury (in conjunction with the program of the
Secretary regarding health-status goals for
2010, commonly referred to as Healthy People
2010), including—
(A) the national dissemination of information on—
(i) incidence and prevalence; and
(ii) information relating to traumatic
brain injury and the sequelae of secondary
conditions arising from traumatic brain
injury upon discharge from hospitals and
emergency departments; and

(July 1, 1944, ch. 373, title III, § 393A, formerly
§ 393B, as added Pub. L. 106–386, div. B, title IV,
§ 1401(a), Oct. 28, 2000, 114 Stat. 1512; amended
Pub. L. 109–162, title III, § 302, Jan. 5, 2006, 119
Stat. 3004; renumbered § 393C, Pub. L. 110–202,
§ 2(1), Apr. 23, 2008, 122 Stat. 697; renumbered
§ 393A, Pub. L. 110–206, § 2(1), Apr. 28, 2008, 122
Stat. 714.)

(B) the provision of information in primary care settings, including emergency
rooms and trauma centers, concerning the
availability of State level services and resources.
(c) Coordination of activities
The Secretary shall ensure that activities
under this section are coordinated as appropriate with other agencies of the Public Health
Service that carry out activities regarding traumatic brain injury.
(d) ‘‘Traumatic brain injury’’ defined
For purposes of this section, the term ‘‘traumatic brain injury’’ means an acquired injury to
the brain. Such term does not include brain dysfunction caused by congenital or degenerative
disorders, nor birth trauma, but may include
brain injuries caused by anoxia due to trauma.
The Secretary may revise the definition of such
term as the Secretary determines necessary,
after consultation with States and other appropriate public or nonprofit private entities.

CODIFICATION
Section was formerly classified to section 280b–1c of
this title. Pub. L. 110–206, which directed the renumbering of ‘‘the section 393B (42 U.S.C. 280b–1c)’’ of act July
1, 1944, ‘‘relating to the use of allotments for rape prevention education’’ as section 393A and the transfer of
that section so as to appear after section 393 of that
Act, was executed by renumbering section 393C of that
Act as 393A and transferring the renumbered provisions
to this section, to reflect the probable intent of Congress and the renumbering of section 393B as 393C by
section 2(1) of Pub. L. 110–202.
PRIOR PROVISIONS
A prior section 393A of act July 1, 1944, was renumbered section 393B and is classified to section 280b–1c of
this title.
AMENDMENTS
2006—Subsec. (c). Pub. L. 109–162 reenacted heading
without change and amended text generally. Prior to
amendment, text contained provisions in par. (1) authorizing appropriations for fiscal years 2001 through
2005 and in par. (2) directing an allotment under subsec.
(b) of this section.

§ 280b–1c. Prevention of traumatic brain injury
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,

(July 1, 1944, ch. 373, title III, § 393B, formerly
§ 393A, as added Pub. L. 104–166, § 1, July 29, 1996,
110 Stat. 1445; amended Pub. L. 106–310, div. A,
title XIII, § 1301(a), Oct. 17, 2000, 114 Stat. 1137;
renumbered § 393B and amended Pub. L. 110–206,
§§ 2(2), 3(a), Apr. 28, 2008, 122 Stat. 714.)
CODIFICATION
Section was formerly classified to section 280b–1b of
this title.
PRIOR PROVISIONS
Prior sections 393B of act July 1, 1944, were renumbered sections 393A and 393C and are classified to sections 280b–1b and 280b–1d, respectively, of this title.

§ 280b–1d

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Page 422

AMENDMENTS

PRIOR PROVISIONS

2008—Subsec. (b)(3)(A)(ii). Pub. L. 110–206, § 3(a), substituted ‘‘from hospitals and emergency departments’’
for ‘‘from hospitals and trauma centers’’.
2000—Subsec. (b)(3). Pub. L. 106–310, § 1301(a)(1), added
par. (3).
Subsec. (d). Pub. L. 106–310, § 1301(a)(2), substituted
‘‘anoxia due to trauma’’ for ‘‘anoxia due to near drowning’’ and inserted ‘‘, after consultation with States and
other appropriate public or nonprofit private entities’’
after ‘‘Secretary determines necessary’’.

A prior section 393C of act July 1, 1944, was renumbered section 393A and is classified to section 280b–1b of
this title.

§ 280b–1d. National program for traumatic brain
injury surveillance and registries
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to States or their designees to
develop or operate the State’s traumatic brain
injury surveillance system or registry to determine the incidence and prevalence of traumatic
brain injury and related disability, to ensure the
uniformity of reporting under such system or
registry, to link individuals with traumatic
brain injury to services and supports, and to
link such individuals with academic institutions
to conduct applied research that will support
the development of such surveillance systems
and registries as may be necessary. A surveillance system or registry under this section shall
provide for the collection of data concerning—
(1) demographic information about each
traumatic brain injury;
(2) information about the circumstances surrounding the injury event associated with
each traumatic brain injury;
(3) administrative information about the
source of the collected information, dates of
hospitalization and treatment, and the date of
injury; and
(4) information characterizing the clinical
aspects of the traumatic brain injury, including the severity of the injury, outcomes of the
injury, the types of treatments received, and
the types of services utilized.
(b) Report
Not later than 18 months after April 28, 2008,
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention
and the Director of the National Institutes of
Health and in consultation with the Secretary of
Defense and the Secretary of Veterans Affairs,
shall submit to the relevant committees of Congress a report that contains the findings derived
from an evaluation concerning activities and
procedures that can be implemented by the Centers for Disease Control and Prevention to improve the collection and dissemination of compatible epidemiological studies on the incidence
and prevalence of traumatic brain injury in individuals who were formerly in the military. The
report shall include recommendations on the
manner in which such agencies can further collaborate on the development and improvement
of traumatic brain injury diagnostic tools and
treatments.
(July 1, 1944, ch. 373, title III, § 393C, formerly
§ 393B, as added Pub. L. 106–310, div. A, title XIII,
§ 1301(b), Oct. 17, 2000, 114 Stat. 1137; renumbered
§ 393C and amended Pub. L. 110–206, §§ 2(3), 3(b),
(c), Apr. 28, 2008, 122 Stat. 714, 715.)

AMENDMENTS
2008—Pub. L. 110–206, § 3(b)(1), inserted ‘‘surveillance
and’’ after ‘‘National program for traumatic brain injury’’ in section catchline.
Subsec. (a). Pub. L. 110–206, § 3(b)(2), in introductory
provisions, substituted ‘‘may make grants to States or
their designees to develop or operate the State’s traumatic brain injury surveillance system or registry to
determine the incidence and prevalence of traumatic
brain injury and related disability, to ensure the uniformity of reporting under such system or registry, to
link individuals with traumatic brain injury to services
and supports, and to link such individuals with academic institutions to conduct applied research that
will support the development of such surveillance systems and registries as may be necessary. A surveillance
system or registry under this section shall provide for
the collection of data concerning—’’ for ‘‘may make
grants to States or their designees to operate the
State’s traumatic brain injury registry, and to academic institutions to conduct applied research that
will support the development of such registries, to collect data concerning—’’.
Subsec. (b). Pub. L. 110–206, § 3(c), added subsec. (b).

§ 280b–1e. Study on traumatic brain injury
(a) Study
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention
with respect to paragraph (1) and in consultation with the Director of the National Institutes
of Health and other appropriate entities with respect to paragraphs (2), (3), and (4), may conduct
a study with respect to traumatic brain injury
for the purpose of carrying out the following:
(1) In collaboration with appropriate State
and local health-related agencies—
(A) determining the incidence of traumatic
brain injury and prevalence of traumatic
brain injury related disability and the clinical aspects of the disability in all age groups
and racial and ethnic minority groups in the
general population of the United States, including institutional settings, such as nursing homes, correctional facilities, psychiatric hospitals, child care facilities, and
residential institutes for people with developmental disabilities; and
(B) reporting national trends in traumatic
brain injury.
(2) Identifying common therapeutic interventions which are used for the rehabilitation
of individuals with such injuries, and, subject
to the availability of information, including
an analysis of—
(A) the effectiveness of each such intervention in improving the functioning, including
return to work or school and community
participation, of individuals with brain injuries;
(B) the comparative effectiveness of interventions employed in the course of rehabilitation of individuals with brain injuries to
achieve the same or similar clinical outcome; and
(C) the adequacy of existing measures of
outcomes and knowledge of factors influencing differential outcomes.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Identifying interventions and therapies
that can prevent or remediate the development of secondary neurologic conditions related to traumatic brain injury.
(4) Developing practice guidelines for the rehabilitation of traumatic brain injury at such
time as appropriate scientific research becomes available.
(b) Dates certain for reports
If the study is conducted under subsection (a),
the Secretary shall, not later than 3 years after
April 28, 2008, submit to Congress a report describing findings made as a result of carrying
out such subsection (a).
(c) Definition
For purposes of this section, the term ‘‘traumatic brain injury’’ means an acquired injury to
the brain. Such term does not include brain dysfunction caused by congenital or degenerative
disorders, nor birth trauma, but may include
brain injuries caused by anoxia due to trauma
including near drowning. The Secretary may revise the definition of such term as the Secretary
determines necessary.
(July 1, 1944, ch. 373, title III, § 393C–1, as added
Pub. L. 110–206, § 4, Apr. 28, 2008, 122 Stat. 715.)
§ 280b–1f. Prevention of falls among older adults
(a) Public education
The Secretary may—
(1) oversee and support a national education
campaign to be carried out by a nonprofit organization with experience in designing and
implementing national injury prevention programs, that is directed principally to older
adults, their families, and health care providers, and that focuses on reducing falls among
older adults and preventing repeat falls; and
(2) award grants, contracts, or cooperative
agreements to qualified organizations, institutions, or consortia of qualified organizations
and institutions, specializing, or demonstrating expertise, in falls or fall prevention, for
the purpose of organizing State-level coalitions of appropriate State and local agencies,
safety, health, senior citizen, and other organizations to design and carry out local education campaigns, focusing on reducing falls
among older adults and preventing repeat
falls.
(b) Research
(1) In general
The Secretary may—
(A) conduct and support research to—
(i) improve the identification of older
adults who have a high risk of falling;
(ii) improve data collection and analysis
to identify fall risk and protective factors;
(iii) design, implement, and evaluate the
most effective fall prevention interventions;
(iv) improve strategies that are proven
to be effective in reducing falls by tailoring these strategies to specific populations
of older adults;
(v) conduct research in order to maximize the dissemination of proven, effective
fall prevention interventions;

§ 280b–1f

(vi) intensify proven interventions to
prevent falls among older adults;
(vii) improve the diagnosis, treatment,
and rehabilitation of elderly fall victims
and older adults at high risk for falls; and
(viii) assess the risk of falls occurring in
various settings;
(B) conduct research concerning barriers
to the adoption of proven interventions with
respect to the prevention of falls among
older adults;
(C) conduct research to develop, implement, and evaluate the most effective approaches to reducing falls among high-risk
older adults living in communities and longterm care and assisted living facilities; and
(D) evaluate the effectiveness of community programs designed to prevent falls
among older adults.
(2) Educational support
The Secretary, either directly or through
awarding grants, contracts, or cooperative
agreements to qualified organizations, institutions, or consortia of qualified organizations
and institutions, specializing, or demonstrating expertise, in falls or fall prevention, may
provide professional education for physicians
and allied health professionals, and aging service providers in fall prevention, evaluation,
and management.
(c) Demonstration projects
The Secretary may carry out the following:
(1) Oversee and support demonstration and
research projects to be carried out by qualified
organizations, institutions, or consortia of
qualified organizations and institutions, specializing, or demonstrating expertise, in falls
or fall prevention, in the following areas:
(A) A multistate demonstration project assessing the utility of targeted fall risk
screening and referral programs.
(B) Programs designed for communitydwelling older adults that utilize multicomponent fall intervention approaches, including physical activity, medication assessment and reduction when possible, vision enhancement, and home modification strategies.
(C) Programs that are targeted to new fall
victims who are at a high risk for second
falls and which are designed to maximize
independence and quality of life for older
adults, particularly those older adults with
functional limitations.
(D) Private sector and public-private partnerships to develop technologies to prevent
falls among older adults and prevent or reduce injuries if falls occur.
(2)(A) Award grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, to design, implement, and evaluate fall
prevention programs using proven intervention strategies in residential and institutional
settings.
(B) Award 1 or more grants, contracts, or cooperative agreements to 1 or more qualified

§ 280b–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

organizations, institutions, or consortia of
qualified organizations and institutions, specializing, or demonstrating expertise, in falls
or fall prevention, in order to carry out a
multistate demonstration project to implement and evaluate fall prevention programs
using proven intervention strategies designed
for single and multifamily residential settings
with high concentrations of older adults, including—
(i) identifying high-risk populations;
(ii) evaluating residential facilities;
(iii) conducting screening to identify highrisk individuals;
(iv) providing fall assessment and risk reduction interventions and counseling;
(v) coordinating services with health care
and social service providers; and
(vi) coordinating post-fall treatment and
rehabilitation.
(3) Award 1 or more grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified
organizations and institutions, specializing, or
demonstrating expertise, in falls or fall prevention, to conduct evaluations of the effectiveness of the demonstration projects described in this subsection.
(d) Priority
In awarding grants, contracts, or cooperative
agreements under this section, the Secretary
may give priority to entities that explore the
use of cost-sharing with respect to activities
funded under the grant, contract, or agreement
to ensure the institutional commitment of the
recipients of such assistance to the projects
funded under the grant, contract, or agreement.
Such non-Federal cost sharing contributions
may be provided directly or through donations
from public or private entities and may be in
cash or in-kind, fairly evaluated, including
plant, equipment, or services.
(e) Study of effects of falls on health care costs
(1) In general
The Secretary may conduct a review of the
effects of falls on health care costs, the potential for reducing falls, and the most effective
strategies for reducing health care costs associated with falls.
(2) Report
If the Secretary conducts the review under
paragraph (1), the Secretary shall, not later
than 36 months after April 23, 2008, submit to
Congress a report describing the findings of
the Secretary in conducting such review.
(July 1, 1944, ch. 373, title III, § 393D, as added
Pub. L. 110–202, § 2(2), Apr. 23, 2008, 122 Stat. 697.)
§ 280b–2. General provisions
(a) Advisory committee
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish an advisory committee to advise
the Secretary and such Director with respect to
the prevention and control of injuries.
(b) Technical assistance
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,

Page 424

may provide technical assistance to public and
nonprofit private entities with respect to the
planning, development, and operation of any
program or service carried out pursuant to this
part. The Secretary may provide such technical
assistance directly or through grants or contracts.
(c) Biennial report
Not later than February 1 of 1995 and of every
second year thereafter, the Secretary, acting
through the Director of the Centers for Disease
Control and Prevention, shall submit to the
Committee on Energy and Commerce of the
House of Representatives, and to the Committee
on Labor and Human Resources of the Senate, a
report describing the activities carried out
under this part during the preceding 2 fiscal
years. Such report shall include a description of
such activities that were carried out with respect to interpersonal violence within families
and among acquaintances and with respect to
rural areas.
(July 1, 1944, ch. 373, title III, § 394, formerly
§ 393, as added Pub. L. 99–649, § 3, Nov. 10, 1986, 100
Stat. 3634; amended Pub. L. 101–558, § 2(c), Nov.
15, 1990, 104 Stat. 2772; Pub. L. 102–531, title III,
§ 312(d)(5), Oct. 27, 1992, 106 Stat. 3504; renumbered § 394 and amended Pub. L. 103–183, title II,
§§ 201(1), 202, Dec. 14, 1993, 107 Stat. 2231, 2232.)
PRIOR PROVISIONS
A prior section 280b–2, act July 1, 1944, ch. 373, title
III, § 392, as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79
Stat. 1060; amended Mar. 13, 1970, Pub. L. 91–212,
§ 10(b)(4), (d)(2)(A), 84 Stat. 66, 67; July 23, 1974, Pub. L.
93–353, title II, § 202(c), 88 Stat. 372, related to composition, functions, etc., of National Medical Libraries Assistance Advisory Board, prior to repeal by Pub. L.
99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
A prior section 394 of act July 1, 1944, was renumbered
section 394A and is classified to section 280b–3 of this
title.
AMENDMENTS
1993—Pub. L. 103–183, § 202, amended section generally.
Prior to amendment, section read as follows: ‘‘By not
later than September 30, 1992, the Secretary, through
the Director of the Centers for Disease Control and Prevention, shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources
of the Senate, a report describing the activities conducted or supported under this part. The report shall
include—
‘‘(1) information regarding the practical applications of research conducted pursuant to subsection
(a) of section 280b of this title, including information
that has not been disseminated under subsection (b)
of such section; and
‘‘(2) information on such activities regarding the
prevention and control of injuries in rural areas, including information regarding injuries that are particular to rural areas.’’
1992—Pub. L. 102–531 substituted ‘‘Centers for Disease
Control and Prevention’’ for ‘‘Centers for Disease Control’’ in introductory provisions.
1990—Pub. L. 101–558 amended section generally. Prior
to amendment, section read as follows: ‘‘By January 1,
1989, the Secretary, through the Director of the Centers
for Disease Control, shall prepare and transmit to the
Congress a report analyzing the incidence and causes of
childhood injuries in the United States and containing
recommendations for such legislation with respect to
injury control as the Secretary considers appropriate.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
CHANGE OF NAME

Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by Congress, its duration is
otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 280b–3. Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated
$50,000,000 for fiscal year 1994, such sums as may
be necessary for each of the fiscal years 1995
through 1998, and such sums as may be necessary for each of the fiscal years 2001 through
2005..1
(July 1, 1944, ch. 373, title III, § 394A, formerly
§ 394, as added Pub. L. 99–649, § 3, Nov. 10, 1986, 100
Stat. 3634; amended Pub. L. 101–558, § 2(d), Nov.
15, 1990, 104 Stat. 2773; renumbered § 394A and
amended Pub. L. 103–183, title II, §§ 201(1), 204,
Dec. 14, 1993, 107 Stat. 2231, 2233; Pub. L. 106–310,
div. A, title XIII, § 1306, Oct. 17, 2000, 114 Stat.
1143.)

§ 280b–4

out sections 280b and 280b–1 of this title, there are authorized to be appropriated $10,000,000 for each of the
fiscal years 1988, 1989, and 1990, $30,000,000 for fiscal year
1991, and such sums as may be necessary for each of the
fiscal years 1992 and 1993.’’
1990—Pub. L. 101–558 struck out subsec. (a) designation, inserted before period at end of first sentence
‘‘, $30,000,000 for fiscal year 1991, and such sums as may
be necessary for each of the fiscal years 1992 and 1993’’,
and struck out at end ‘‘Of the amounts appropriated
under this section for any fiscal year, not more than 20
percent may be used for Federal administrative expenses to carry out such section for such fiscal year.’’

§ 280b–4. Study conducted by the Centers for Disease Control and Prevention
(a) Purposes
The Secretary of Health and Human Services
acting through the National Center for Injury
Prevention and Control at the Centers for Disease Control 1 Prevention shall make grants to
entities, including domestic and sexual assault
coalitions and programs, research organizations,
tribal organizations, and academic institutions
to support research to examine prevention and
intervention programs to further the understanding of sexual and domestic violence by and
against adults, youth, and children.
(b) Use of funds
The research conducted under this section
shall include evaluation and study of best practices for reducing and preventing violence
against women and children addressed by the
strategies included in Department of Health and
Human Services-related provisions 2 this title,3
including strategies addressing underserved
communities.
(c) Authorization of appropriations
There shall be authorized to be appropriated
to carry out this title $2,000,000 for each of the
fiscal years 2007 through 2011.
(Pub. L. 109–162, title IV, § 402, Jan. 5, 2006, 119
Stat. 3023.)
REFERENCES IN TEXT
This title, referred to in subsecs. (b) and (c), is title
IV of Pub. L. 109–162, Jan. 5, 2006, 119 Stat. 3017, which
enacted this section and part L (§ 14043d et seq.) of subchapter III of chapter 136 and section 14045c of this
title. For complete classification of title IV to the
Code, see Tables.

PRIOR PROVISIONS

CODIFICATION

A prior section 280b–3, act July 1, 1944, ch. 373, title
III, § 393, as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79
Stat. 1060; amended Mar. 13, 1970, Pub. L. 91–212, §§ 2(a),
3, 10(d)(2), 84 Stat. 63, 64, 67, related to grants for construction of medical library facilities, prior to repeal
by Pub. L. 93–353, title II, § 202(d), July 23, 1974, 88 Stat.
372.

Section was enacted as part of the Violence Against
Women and Department of Justice Reauthorization Act
of 2005, and not as part of the Public Health Service Act
which comprises this chapter.

AMENDMENTS
2000—Pub. L. 106–310, which directed the amendment
of this section by striking out ‘‘and’’ after ‘‘1994’’, was
executed by striking ‘‘and’’ after ‘‘1994,’’ to reflect the
probable intent of Congress.
Pub. L. 106–310 inserted before period at end ‘‘, and
such sums as may be necessary for each of the fiscal
years 2001 through 2005.’’
1993—Pub. L. 103–183, § 204, amended section generally.
Prior to amendment, section read as follows: ‘‘To carry

PRIOR PROVISIONS
Prior sections 280b–4 to 280b–11 were repealed by Pub.
L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
Section 280b–4, act July 1, 1944, ch. 373, title III, § 393,
formerly § 394, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1062; amended Mar. 13, 1970, Pub. L. 91–212,
§§ 2(b), 10(d)(2)(A), 84 Stat. 63, 67; June 18, 1973, Pub. L.
93–45, title I, § 107(a), 87 Stat. 92; renumbered § 393 and
amended July 23, 1974, Pub. L. 93–353, title II, §§ 203(a),
204, 88 Stat. 372, 373, related to grants for training in
medical library sciences.
1 So

in original. Probably should be followed by ‘‘and’’.
in original. Probably should be followed by ‘‘of’’.
3 See References in Text note below.
2 So

1 So

in original.

§ 280c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 280b–5, act July 1, 1944, ch. 373, title III, § 394,
formerly § 395, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1062; amended Mar. 13, 1970, Pub. L. 91–212,
§§ 2(c), (d), 4(a), 5(a), 10(c)(1)(A), (B), (2)(A)–(C), (d)(2)(A),
84 Stat. 63, 64, 66, 67; June 18, 1973, Pub. L. 93–45, title
I, § 107(b), (c), 87 Stat. 92; renumbered § 394 and amended
July 23, 1974, Pub. L. 93–353, title II, §§ 203(b), 204, 88
Stat. 372, 373, related to assistance for special scientific
projects; research and development in medical library
science and related fields.
Section 280b–6, act July 1, 1944, ch. 373, title III, § 396,
as added Oct. 22, 1965, Pub. L. 89–291, § 2, 79 Stat. 1063,
was redesignated as subsecs. (b) and (c) of section 280b–5
of this title by Pub. L. 91–212, § 10(c)(2), Mar. 13, 1970, 84
Stat. 66.
Section 280b–7, act July 1, 1944, ch. 373, title III, § 395,
formerly § 397, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1063; renumbered § 396 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(e), 6(a)(1), (2), 10(c)(3), (d)(2)(A),
84 Stat. 63, 64, 67; June 18, 1973, Pub. L. 93–45, title I,
§ 107(d), 87 Stat. 92; renumbered § 395 and amended July
23, 1974, Pub. L. 93–353, title II, §§ 203(c), 204, 88 Stat. 372,
373, related to grants for establishing, expanding, and
improving basic medical library or related resources.
Section 280b–8, act July 1, 1944, ch. 373, title III, § 396,
formerly § 398, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1065; renumbered § 397 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(f), 7, 10(c)(3), (d)(2)(A), 84 Stat.
63, 65, 67; June 18, 1973, Pub. L. 93–45, title I, § 107(e), 87
Stat. 92; renumbered § 396 and amended July 23, 1974,
Pub. L. 93–353, title II, §§ 202(e), (f), 203(d), 204, 88 Stat.
372, 373, related to grants for establishment of regional
medical libraries.
Section 280b–9, act July 1, 1944, ch. 373, title III, § 397,
formerly § 399, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1066; renumbered § 398 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(g), 8, 10(c)(3), (d)(2)(A), 84 Stat.
63, 65, 67; June 18, 1973, Pub. L. 93–45, title I, § 107(f), 87
Stat. 92; renumbered § 397 and amended July 23, 1974,
Pub. L. 93–353, title II, §§ 203(e), 204, 88 Stat. 372, 373, related to grants to provide support for biomedical scientific publications.
Section 280b–10, act July 1, 1944, ch. 373, title III, § 398,
formerly § 399a, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1066; renumbered § 399, Mar. 13, 1970, Pub. L.
91–212, § 10(c)(3), 84 Stat. 67; renumbered § 398, July 23,
1974, Pub. L. 93–353, title II, § 204, 88 Stat. 373, related to
the continuing availability of appropriated funds.
Section 280b–11, act July 1, 1944, ch. 373, title III, § 399,
formerly § 399b, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1066; renumbered § 399a and amended Mar. 13,
1970, Pub. L. 91–212, § 10(c)(3), (d)(2)(A), 84 Stat. 67; renumbered § 399, July 23, 1974, Pub. L. 93–353, title II,
§ 204, 88 Stat. 373; Oct. 17, 1979, Pub. L. 96–88, title V,
§ 509(b), 93 Stat. 695, related to the maintenance of
records by recipients of grants and audits thereof by
the Secretary of Health and Human Services and the
Comptroller General of the United States.
A prior section 280b–12, act July 1, 1944, ch. 373, title
III, § 399b, as added Mar. 13, 1970, Pub. L. 91–212, § 9, 84
Stat. 65, related to transfer of funds, prior to repeal by
Pub. L. 93–353, title II, § 204, July 23, 1974, 88 Stat. 373,
applicable with respect to fiscal years beginning after
June 30, 1974.

PART K—HEALTH CARE SERVICES IN THE HOME

Page 426

SUBPART I—GRANTS FOR DEMONSTRATION
PROJECTS

§ 280c. Establishment of program
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make not less than 5, and
not more than 20, grants to States for the purpose of assisting grantees in carrying out demonstration projects—
(1) to identify low-income individuals who
can avoid institutionalization or prolonged
hospitalization if skilled medical services,
skilled nursing care services, homemaker or
home health aide services, or personal care
services are provided in the homes of the individuals;
(2) to pay the costs of the provision of such
services in the homes of such individuals; and
(3) to coordinate the provision by public and
private entities of such services, and other
long-term care services, in the homes of such
individuals.
(b) Requirement with respect to age of recipients
of services
The Secretary may not make a grant under
subsection (a) of this section to a State unless
the State agrees to ensure that—
(1) not less than 25 percent of the grant is expended to provide services under such subsection to individuals who are not less than 65
years of age; and
(2) of the portion of the grant reserved by
the State for purposes of complying with paragraph (1), not less than 10 percent is expended
to provide such services to individuals who are
not less than 85 years of age.
(c) Relationship to items and services under
other programs
A State may not make payments from a grant
under subsection (a) of this section for any item
or service to the extent that payment has been
made, or can reasonably be expected to be made,
with respect to such item or service—
(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services
on a prepaid basis.
(July 1, 1944, ch. 373, title III, § 395, as added Pub.
L. 100–175, title VI, § 602, Nov. 29, 1987, 101 Stat.
979; amended Pub. L. 101–557, title I, § 101(a)–(c),
Nov. 15, 1990, 104 Stat. 2766; Pub. L. 102–108, § 2(f),
Aug. 17, 1991, 105 Stat. 550.)

AMENDMENTS

PRIOR PROVISIONS

1993—Pub. L. 103–43, title XX, § 2008(i)(2)(B)(i), June 10,
1993, 107 Stat. 213, redesignated part L ‘‘Health Care
Services in the Home’’ as K. Former part K ‘‘Injury
Control’’ redesignated J.
1990—Pub. L. 101–616, title I, § 101(a)(1), Nov. 16, 1990,
104 Stat. 3279, redesignated part J ‘‘Injury Control’’ as
K. Former part K ‘‘Health Care Services in the Home’’
redesignated L.

A prior section 280C, act July 1, 1944, ch. 373, title III,
§ 399A, formerly § 399c, as added Dec. 29, 1973, Pub. L.
93–222, § 3, 87 Stat. 934; renumbered § 399A, July 29, 1975,
Pub. L. 94–63, title VI, § 607(a), (c), 89 Stat. 351, provided
for programs designed to assure the quality of health
care, prior to repeal by Pub. L. 95–623, § 11(b), Nov. 9,
1978, 92 Stat. 3455.
A prior section 395 of act July 1, 1944, ch. 373, title III,
formerly § 397, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1063; renumbered § 396 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(e), 6(a)(1), (2), 10(c)(3), (d)(2)(A),
84 Stat. 63, 64, 67; June 18, 1973, Pub. L. 93–45, title I,
§ 107(d), 87 Stat. 92; renumbered § 395 and amended July

PRIOR PROVISIONS
A prior part K, added Pub. L. 93–222, § 3, Dec. 29, 1973,
87 Stat. 934, related to quality assurance, prior to repeal by Pub. L. 95–623, § 11(b), Nov. 9, 1978, 92 Stat. 3455.

Page 427

TITLE 42—THE PUBLIC HEALTH AND WELFARE

23, 1974, Pub. L. 93–353, title II, §§ 203(c), 204, 88 Stat. 372,
373, which related to grants for establishing, expanding,
and improving basic medical library or related resources, was classified to section 280b–7 of this title,
prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99
Stat. 879.
AMENDMENTS
1991—Subsec. (a)(1). Pub. L. 102–108 inserted ‘‘skilled
medical services,’’ after ‘‘if’’.
1990—Subsec. (a). Pub. L. 101–557, § 101(a), substituted
‘‘shall make not less than 5, and not more than 20,
grants’’ for ‘‘shall make not less than 3, and not more
than 5, grants’’.
Subsec. (a)(1). Pub. L. 101–557, § 101(b), substituted
‘‘skilled nursing care services, homemaker or home
health aide services, or personal care services are provided in the homes of the individuals’’ for ‘‘skilled medical services or related health services (or both) are
provided in the homes of the individuals’’.
Subsec. (b). Pub. L. 101–557, § 101(c), substituted ‘‘to
ensure that—’’ and pars. (1) and (2) for ‘‘to ensure that
not less than 25 percent of individuals receiving services pursuant to subsection (a) of this section are individuals who are not less than 65 years of age’’.
EFFECTIVE DATE
Part effective Oct. 1, 1987, see section 701(a) of Pub. L.
100–175, set out as an Effective Date of 1987 Amendment
note under section 3001 of this title.
SHORT TITLE
For short title of title VI of Pub. L. 100–175, which enacted this part as the ‘‘Health Care Services in the
Home Act of 1987’’, see section 601 of Pub. L. 100–175, set
out as a Short Title of 1987 Amendments note under
section 201 of this title.

§ 280c–1. Limitation on duration of grant and requirement of matching funds
(a) Limitation on duration of grant
The period during which payments are made
to a State from a grant under section 280c(a) of
this title may not exceed 3 years. Such payments shall be subject to annual evaluation by
the Secretary.
(b) Requirement of matching funds
(1)(A) For the first year of payments to a
State from a grant under section 280c(a) of this
title, the Secretary may not make such payments in an amount exceeding 75 percent of the
costs of services to be provided by the State pursuant to such section.
(B) For the second year of such payments to a
State, the Secretary may not make such payments in an amount exceeding 65 percent of the
costs of such services.
(C) For the third year of such payments to a
State, the Secretary may not make such payments in an amount exceeding 55 percent of the
costs of such services.
(2) The Secretary may not make a grant under
section 280c(a) of this title to a State unless the
State agrees to make available, directly or
through donations from public or private entities, non-Federal contributions toward the costs
of services to be provided pursuant to such section in an amount equal to—
(A) for the first year of payments to the
State from the grant, not less than $25 (in cash
or in kind under subsection (c) of this section)
for each $75 of Federal funds provided in the
grant;

§ 280c–2

(B) for the second year of such payments to
the State, not less than $35 (in cash or in kind
under subsection (c) of this section) for each
$65 of such Federal funds; and
(C) for the third year of such payments to
the State, not less than $45 (in cash or in kind
under subsection (c) of this section) for each
$55 of such Federal funds.
(c) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in
kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal
Government, may not be included in determining the amount of such non-Federal contributions.
(July 1, 1944, ch. 373, title III, § 396, as added Pub.
L. 100–175, title VI, § 602, Nov. 29, 1987, 101 Stat.
979.)
PRIOR PROVISIONS
A prior section 396 of act July 1, 1944, ch. 373, title III,
formerly § 398, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1065; renumbered § 397 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(f), 7, 10(c)(3), (d)(2)(A), 84 Stat.
63, 65, 67; June 18, 1973, Pub. L. 93–45, title I, § 107(e), 87
Stat. 92; renumbered § 396 and amended July 23, 1974,
Pub. L. 93–353, title II, §§ 202(e), (f), 203(d), 204, 88 Stat.
372, 373, which related to grants for establishment of regional medical libraries, was classified to section 280b–8
of this title, prior to repeal by Pub. L. 99–158, § 3(b),
Nov. 20, 1985, 99 Stat. 879.

§ 280c–2. General provisions
(a) Limitation on administrative expenses
The Secretary may not make a grant under
section 280c(a) of this title to a State unless the
State agrees that not more than 10 percent of
the grant will be expended for administrative
expenses with respect to the grant.
(b) Description of intended use of grant
The Secretary may not make a grant under
section 280c(a) of this title to a State unless—
(1) the State submits to the Secretary a description of the purposes for which the State
intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be
supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to section 280c(a) of
this title and the average costs of providing
such services to each such individual; and
(B) a description of the manner in which
such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
section 280c(a) of this title to a State unless the
State has submitted to the Secretary an application for the grant. The application shall—
(1) contain the description of intended expenditures required in subsection (b) of this
section;

§ 280c–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) with respect to carrying out the purpose
for which the grant is to be made, provide assurances of compliance satisfactory to the
Secretary; and
(3) otherwise be in such form, be made in
such manner, and contain such information
and agreements as the Secretary determines
to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made
under section 280c(a) of this title; and
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as
a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart,
there are authorized to be appropriated $5,000,000
for each of the fiscal years 1988 through 1990,
$7,500,000 for fiscal year 1991, and such sums as
may be necessary for each of the fiscal years
1992 and 1993.
(July 1, 1944, ch. 373, title III, § 397, as added Pub.
L. 100–175, title VI, § 602, Nov. 29, 1987, 101 Stat.
980; amended Pub. L. 101–557, title I, § 101(d), Nov.
15, 1990, 104 Stat. 2766.)
PRIOR PROVISIONS
A prior section 397 of act July 1, 1944, ch. 373, title III,
formerly § 399, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1066; renumbered § 398 and amended Mar. 13,
1970, Pub. L. 91–212, §§ 2(g), 8, 10(c)(3), (d)(2)(A), 84 Stat.
63, 65, 67; June 18, 1973, Pub. L. 93–45, title I, § 107(f), 87
Stat. 92; renumbered § 397 and amended July 23, 1974,
Pub. L. 93–353, title II, §§ 203(e), 204, 88 Stat. 372, 373,
which related to grants to provide support for biomedical scientific publications, was classified to section 280b–9 of this title, prior to repeal by Pub. L.
99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
AMENDMENTS
1990—Subsec. (e). Pub. L. 101–557 substituted ‘‘there
are’’ for ‘‘there is’’ and inserted before period at end
‘‘, $7,500,000 for fiscal year 1991, and such sums as may
be necessary for each of the fiscal years 1992 and 1993’’.
SUBPART II—GRANTS FOR DEMONSTRATION PROJECTS WITH RESPECT TO ALZHEIMER’S DISEASE

§ 280c–3. Establishment of program
(a) In general
The Secretary shall make grants to States for
the purpose of assisting grantees in carrying out
demonstration projects for planning, establishing, and operating programs—
(1) to coordinate the development and operation with public and private organizations of
diagnostic, treatment, care management, respite care, legal counseling, and education services provided within the State to individuals
with Alzheimer’s disease or related disorders
and to the families and care providers of such
individuals;
(2) to provide home health care, personal
care, day care, companion services, short-term
care in health facilities, and other respite care
to individuals with Alzheimer’s disease or related disorders who are living in single family
homes or in congregate settings;

Page 428

(3) to improve the access of such individuals
to home-based or community-based long-term
care services (subject to the services being
provided by entities that were providing such
services in the State involved as of October 1,
1995), particularly such individuals who are
members of racial or ethnic minority groups,
who have limited proficiency in speaking the
English language, or who live in rural areas;
and
(4) to provide to health care providers, to individuals with Alzheimer’s disease or related
disorders, to the families of such individuals,
to organizations established for such individuals and such families, and to the general public, information with respect to—
(A) diagnostic services, treatment services, and related services available to such
individuals and to the families of such individuals;
(B) sources of assistance in obtaining such
services, including assistance under entitlement programs; and
(C) the legal rights of such individuals and
such families.
(b) Requirement with respect to certain expenditures
The Secretary may not make a grant under
subsection (a) of this section to a State unless
the State agrees to expend not less than 50 percent of the grant for the provision of services described in subsection (a)(2) of this section.
(c) Relationship to items and services under
other programs
A State may not make payments from a grant
under subsection (a) of this section for any item
or service to the extent that payment has been
made, or can reasonably be expected to be made,
with respect to such item or service—
(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services
on a prepaid basis.
(July 1, 1944, ch. 373, title III, § 398, as added Pub.
L. 100–175, title VI, § 602, Nov. 29, 1987, 101 Stat.
981; amended Pub. L. 101–557, title I, § 102(a), (b),
Nov. 15, 1990, 104 Stat. 2767; Pub. L. 105–392, title
III, § 302(a), Nov. 13, 1998, 112 Stat. 3586.)
PRIOR PROVISIONS
A prior section 398 of act July 1, 1944, ch. 373, title III,
formerly § 399a, as added Oct. 22, 1965, Pub. L. 89–291, § 2,
79 Stat. 1066; renumbered § 399, Mar. 13, 1970, Pub. L.
91–212, § 10(c)(3), 84 Stat. 67; renumbered § 398, July 23,
1974, Pub. L. 93–353, title II, § 204, 88 Stat. 373, which related to the continuing availability of appropriated
funds, was classified to section 280b–10 of this title,
prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99
Stat. 879.
AMENDMENTS
1998—Subsec. (a). Pub. L. 105–392, § 302(a)(1), struck
out ‘‘not less than 5, and not more than 15,’’ after
‘‘shall make’’ in introductory provisions.
Subsec. (a)(2). Pub. L. 105–392, § 302(a)(2), inserted
‘‘who are living in single family homes or in congregate
settings’’ after ‘‘disorders’’ and struck out ‘‘and’’ at
end.
Subsec. (a)(3), (4). Pub. L. 105–392, § 302(a)(3), (4), added
par. (3) and redesignated former par. (3) as (4).

Page 429

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 280c–5

1990—Subsec. (a). Pub. L. 101–557, § 102(a), substituted
‘‘shall make not less than 5, and not more than 15,
grants’’ for ‘‘shall make not less than 3, and not more
than 5, grants’’.
Subsec. (a)(1). Pub. L. 101–557, § 102(b), substituted
‘‘with public and private organizations’’ for ‘‘by public
and private organizations’’.

Text read as follows: ‘‘The period during which payments are made to a State from a grant under section
280c–3(a) of this title may not exceed 3 years. Such payments shall be subject to annual evaluation by the Secretary.’’
Subsecs. (b), (c). Pub. L. 105–392, § 302(b)(3), redesignated subsecs. (b) and (c) as (a) and (b), respectively.

§ 280c–4. Requirement of matching funds

§ 280c–5. General provisions

(a) Requirement of matching funds
(1)(A) For the first year of payments to a
State from a grant under section 280c–3(a) of
this title, the Secretary may not make such
payments in an amount exceeding 75 percent of
the costs of services to be provided by the State
pursuant to such section.
(B) For the second year of such payments to a
State, the Secretary may not make such payments in an amount exceeding 65 percent of the
costs of such services.
(C) For the third or subsequent year of such
payments to a State, the Secretary may not
make such payments in an amount exceeding 55
percent of the costs of such services.
(2) The Secretary may not make a grant under
section 280c–3(a) of this title to a State unless
the State agrees to make available, directly or
through donations from public or private entities, non-Federal contributions toward the costs
of services to be provided pursuant to such section in an amount equal to—
(A) for the first year of payments to the
State from the grant, not less than $25 (in cash
or in kind under subsection (c) of this section)
for each $75 of Federal funds provided in the
grant;
(B) for the second year of such payments to
the State, not less than $35 (in cash or in kind
under subsection (c) of this section) for each
$65 of such Federal funds; and
(C) for the third or subsequent year of such
payments to the State, not less than $45 (in
cash or in kind under subsection (c) of this
section) for each $55 of such Federal funds.
(b) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in
kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal
Government, may not be included in determining the amount of such non-Federal contributions.

(a) Limitation on administrative expenses
The Secretary may not make a grant under
section 280c–3(a) of this title to a State unless
the State agrees that not more than 10 percent
of the grant will be expended for administrative
expenses with respect to the grant.
(b) Description of intended use of grant
The Secretary may not make a grant under
section 280c–3(a) of this title to a State unless—
(1) the State submits to the Secretary a description of the purposes for which the State
intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be
supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to section 280c–3(a)
of this title and the average costs of providing such services to each such individual;
and
(B) a description of the manner in which
such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
section 280c–3(a) of this title to a State unless
the State has submitted to the Secretary an application for the grant. The application shall—
(1) contain the description of intended expenditures required in subsection (b) of this
section;
(2) with respect to carrying out the purpose
for which the grant is to be made, provide assurances of compliance satisfactory to the
Secretary; and
(3) otherwise be in such form, be made in
such manner, and contain such information
and agreements as the Secretary determines
to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made
under section 280c–3(a) of this title; and
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as
a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart,
there are authorized to be appropriated $5,000,000
for each of the fiscal years 1988 through 1990,
$7,500,000 for fiscal year 1991, such sums as may
be necessary for each of the fiscal years 1992 and
1993, $8,000,000 for fiscal year 1998, and such sums
as may be necessary for each of the fiscal years
1999 through 2002.

(July 1, 1944, ch. 373, title III, § 398A, formerly
§ 399, as added Pub. L. 100–175, title VI, § 602, Nov.
29, 1987, 101 Stat. 982; renumbered § 398A, Pub. L.
102–321, title V, § 502(1), July 10, 1992, 106 Stat.
427; amended Pub. L. 105–392, title III, § 302(b),
Nov. 13, 1998, 112 Stat. 3586.)
AMENDMENTS
1998—Pub. L. 105–392, § 302(b)(1), substituted ‘‘Requirement of matching funds’’ for ‘‘Limitation on duration
of grant and requirement of matching funds’’ in section
catchline.
Subsec. (a). Pub. L. 105–392, § 302(b)(2)–(4), redesignated subsec. (b) as (a), substituted ‘‘third or subsequent year’’ for ‘‘third year’’ in pars. (1)(C) and (2)(C),
and struck out heading and text of former subsec. (a).

§ 280c–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title III, § 398B, formerly
§ 399A, as added Pub. L. 100–175, title VI, § 602,
Nov. 29, 1987, 101 Stat. 982; amended Pub. L.
101–557, title I, § 102(c), Nov. 15, 1990, 104 Stat.
2767; renumbered § 398B, Pub. L. 102–321, title V,
§ 502(1), July 10, 1992, 106 Stat. 427; Pub. L.
105–392, title III, § 302(c), Nov. 13, 1998, 112 Stat.
3586.)
AMENDMENTS
1998—Subsec. (e). Pub. L. 105–392 substituted ‘‘1991,
such sums’’ for ‘‘1991, and such sums’’ and inserted before period at end ‘‘, $8,000,000 for fiscal year 1998, and
such sums as may be necessary for each of the fiscal
years 1999 through 2002’’.
1990—Subsec. (e). Pub. L. 101–557 substituted ‘‘there
are’’ for ‘‘there is’’ and inserted before period at end
‘‘, $7,500,000 for fiscal year 1991, and such sums as may
be necessary for each of the fiscal years 1992 and 1993’’.
SUBPART III—GRANTS FOR HOME VISITING
SERVICES FOR AT-RISK FAMILIES

§ 280c–6. Projects to improve maternal, infant,
and child health
(a) In general
(1) Establishment of program
The Secretary, acting through the Administrator of the Health Resources and Services
Administration, shall make grants to eligible
entities to pay the Federal share of the cost of
providing the services specified in subsection
(b) of this section to families in which a member is—
(A) a pregnant woman at risk of delivering
an infant with a health or developmental
complication; or
(B) a child less than 3 years of age—
(i) who is experiencing or is at risk of a
health or developmental complication, or
of child abuse or neglect; or
(ii) who has been prenatally exposed to
maternal substance abuse.
(2) Minimum period of awards; administrative
consultations
(A) The Secretary shall award grants under
paragraph (1) for periods of at least three
years.
(B) The Administrator of the Administration
for Children, Youth, and Families and the Director of the National Commission to Prevent
Infant Mortality shall be consulted regarding
the promulgation of program guidelines and
funding priorities under this section.
(3) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1)
only if, in the case of any service under such
paragraph that is covered in the State plan approved under title XIX of the Social Security
Act [42 U.S.C. 1396 et seq.] for the State involved—
(i) the entity involved will provide the
service directly, and the entity has entered
into a participation agreement under the
State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement
with an organization under which the organization will provide the service, and the or-

Page 430

ganization has entered into such a participation agreement and is qualified to receive
such payments.
(B)(i) In the case of an organization making
an agreement under subparagraph (A)(ii) regarding the provision of services under paragraph (1), the requirement established in such
subparagraph regarding a participation agreement shall be waived by the Secretary if the
organization does not, in providing health or
mental health services, impose a charge or accept reimbursement available from any thirdparty payor, including reimbursement under
any insurance policy or under any Federal or
State health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the
public.
(b) Home visiting services for eligible families
With respect to an eligible family, each of the
following services shall, directly or through arrangement with other public or nonprofit private entities, be available (as applicable to the
family member involved) in each project operated with a grant under subsection (a) of this
section:
(1) Prenatal and postnatal health care.
(2) Primary health care for the children, including developmental assessments.
(3) Education for the parents concerning infant care and child development, including the
development and utilization of parent and
teacher resource networks and other family
resource and support networks where such
networks are available.
(4) Upon the request of a parent, providing
the education described in paragraph (3) to
other individuals who have responsibility for
caring for the children.
(5) Education for the parents concerning behaviors that adversely affect health.
(6) Assistance in obtaining necessary health,
mental health, developmental, social, housing,
and nutrition services and other assistance,
including services and other assistance under
maternal and child health programs; the special supplemental nutrition program for
women, infants, and children; section 1786 of
this title; title V of the Social Security Act [42
U.S.C. 701 et seq.]; title XIX of such Act [42
U.S.C. 1396 et seq.] (including the program for
early and periodic screening, diagnostic, and
treatment services described in section 1905(r)
of such Act [42 U.S.C. 1396d(r)]); titles IV and
XIX of the Social Security Act [42 U.S.C. 601 et
seq., 1396 et seq.]; housing programs; other
food assistance programs; and appropriate alcohol and drug dependency treatment programs, according to need.
(c) Considerations in making grants
In awarding grants under subsection (a) of this
section, the Secretary shall take into consideration—
(1) the ability of the entity involved to provide, either directly or through linkages, a

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broad range of preventive and primary health
care services and related social, family support, and developmental services;
(2) different combinations of professional
and lay home visitors utilized within programs that are reflective of the identified
service needs and characteristics of target
populations;
(3) the extent to which the population to be
targeted has limited access to health care, and
related social, family support, and developmental services; and
(4) whether such grants are equitably distributed among urban and rural settings and
whether entities serving Native American
communities are represented among the
grantees.
(d) Federal share
With respect to the costs of carrying out a
project under subsection (a) of this section, a
grant under such subsection for the project may
not exceed 90 percent of such costs. To be eligible to receive such a grant, an applicant must
provide assurances that the applicant will obtain at least 10 percent of such costs from nonFederal funds (and such contributions to such
costs may be in cash or in-kind, including facilities and personnel).
(e) Rule of construction regarding at-risk births
For purposes of subsection (a)(1) of this section, a pregnant woman shall be considered to
be at risk of delivering an infant with a health
or developmental complication if during the
pregnancy the woman—
(1) lacks appropriate access to, or information concerning, early and routine prenatal
care;
(2) lacks the transportation necessary to
gain access to the services described in subsection (b) of this section;
(3) lacks appropriate child care assistance,
which results in impeding the ability of such
woman to utilize health and related social
services;
(4) is fearful of accessing substance abuse
services or child and family support services;
or
(5) is a minor with a low income.
(f) Delivery of services and case management
(1) Case management model
Home visiting services provided under this
section shall be delivered according to a case
management model, and a registered nurse, licensed social worker, or other licensed health
care professional with experience and expertise in providing health and related social
services in home and community settings
shall be assigned as the case manager for individual cases under such model.
(2) Case manager
A case manager assigned under paragraph (1)
shall have primary responsibility for coordinating and overseeing the development of a
plan for each family that is to receive home
visiting services under this section, and for coordinating the delivery of such services provided through appropriate personnel.

§ 280c–6

(3) Appropriate personnel
In determining which personnel shall be utilized in the delivery of services, the case manager shall consider—
(A) the stated objective of the project to
be operated with the grant, as determined
after considering identified gaps in the current service delivery system; and
(B) the nature of the needs of the family to
be served, as determined at the initial assessment of the family that is conducted by
the case manager, and through follow-up
contacts by other providers of home visiting
services.
(4) Family service plan
A case manager, in consultation with a team
established in accordance with paragraph (5)
for the family involved, shall develop a plan
for the family following the initial visit to the
home of the family. Such plan shall reflect—
(A) an assessment of the health and related social service needs of the family;
(B) a structured plan for the delivery of
home visiting services to meet the identified
needs of the family;
(C) the frequency with which such services
are to be provided to the family;
(D) ongoing revisions made as the needs of
family members change; and
(E) the continuing voluntary participation
of the family in the plan.
(5) Home visiting services team
The team to be consulted under paragraph
(4) on behalf of a family shall include, as appropriate, other nursing professionals, physician assistants, social workers, child welfare
professionals, infant and early childhood specialists, nutritionists, and laypersons trained
as home visitors. The case manager shall ensure that the plan is coordinated with those
physician services that may be required by the
mother or child.
(g) Outreach
Each grantee under subsection (a) of this section shall provide outreach and casefinding services to inform eligible families of the availability of home visiting services from the project.
(h) Confidentiality
In accordance with applicable State law, an
entity receiving a grant under subsection (a) of
this section shall maintain confidentiality with
respect to services provided to families under
this section.
(i) Certain assurances
The Secretary may award a grant under subsection (a) of this section only if the entity involved provides assurances satisfactory to the
Secretary that—
(1) the entity will provide home visiting
services with reasonable frequency—
(A) to families with pregnant women, as
early in the pregnancy as is practicable, and
until the infant reaches at least 2 years of
age; and
(B) to other eligible families, for at least 2
years; and
(2) the entity will coordinate with public
health and related social service agencies to

§ 280c–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

prevent duplication of effort and improve the
delivery of comprehensive health and related
social services.
(j) Submission to Secretary of certain information
The Secretary may award a grant under subsection (a) of this section only if the entity involved submits to the Secretary—
(1) a description of the population to be targeted for home visiting services and methods
of outreach and casefinding for identifying eligible families, including the use of lay home
visitors where appropriate;
(2) a description of the types and qualifications of home visitors used by the entity and
the process by which the entity will provide
continuing training and sufficient support to
the home visitors; and
(3) such other information as the Secretary
determines to be appropriate.
(k) Limitation regarding administrative expenses
Not more than 10 percent of a grant under subsection (a) of this section may be expended for
administrative expenses with respect to the
grant. The costs of training individuals to serve
in the project involved are not subject to the
preceding sentence.
(l) Restrictions on use of grant
To be eligible to receive a grant under this
section, an entity must agree that the grant will
not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other
than minor remodeling) any building or other
facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition
for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private
entity.
(m) Reports to Secretary
To be eligible to receive a grant under this
section, an entity must agree to submit an annual report on the services provided under this
section to the Secretary in such manner and
containing such information as the Secretary by
regulation requires. At a minimum, the entity
shall report information concerning eligible
families, including—
(1) the characteristics of the families and
children receiving services under this section;
(2) the usage, nature, and location of the
provider, of preventive health services, including prenatal, primary infant, and child health
care;
(3) the incidence of low birthweight and premature infants;
(4) the length of hospital stays for pre- and
post-partum women and their children;
(5) the incidence of substantiated child abuse
and neglect for all children within participating families;
(6) the number of emergency room visits for
routine health care;

Page 432

(7) the source of payment for health care
services and the extent to which the utilization of health care services, other than routine screening and medical care, available to
the individuals under the program established
under title XIX of the Social Security Act [42
U.S.C. 1396 et seq.], and under other Federal,
State, and local programs, is reduced;
(8) the number and type of referrals made for
health and related social services, including
alcohol and drug treatment services, and the
utilization of such services provided by the
grantee; and
(9) the incidence of developmental disabilities.
(n) Requirement of application
The Secretary may make a grant under subsection (a) of this section only if—
(1) an application for the grant is submitted
to the Secretary;
(2) the application contains the agreements
and assurances required in this section, and
the information required in subsection (j) of
this section;
(3) the application contains evidence that
the preparation of the application has been
coordinated with the State agencies responsible for maternal and child health and child
welfare, and coordinated with services provided under part C of the Individuals with Disabilities Education Act [20 U.S.C. 1431 et seq.];
and
(4) the application is in such form, is made
in such manner, and contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry
out this section.
(o) Peer review
(1) Requirement
In making determinations for awarding
grants under subsection (a) of this section, the
Secretary shall rely on the recommendations
of the peer review panel established under
paragraph (2).
(2) Composition
The Secretary shall establish a review panel
to make recommendations under paragraph (1)
that shall be composed of—
(A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of community-based
primary health services; and
(B) representatives of relevant Federal
agencies, including the Health Resources
and Services Administration, the Substance
Abuse and Mental Health Services Administration, the Administration for Children,
Youth, and Families, the U.S. Advisory
Board on Child Abuse and Neglect, and the
National Commission to Prevent Infant Mortality.
(p) Evaluations
(1) In general
The Secretary shall, directly or through
contracts with public or private entities—
(A) conduct evaluations to determine the
effectiveness of projects under subsection (a)
of this section in reducing the incidence of

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children born with health or developmental
complications, the incidence among children
less than 3 years of age of such complications, and the incidence of child abuse and
neglect; and
(B) not less than once during each 3-year
period, prepare and submit to the appropriate committees of Congress a report concerning the results of such evaluations.
(2) Contents
The evaluations conducted under paragraph
(1) shall—
(A) include a summary of the data contained in the annual reports submitted
under subsection (m) of this section;
(B) assess the relative effectiveness of
projects under subsection (a) of this section
in urban and rural areas, and among programs utilizing differing combinations of
professionals and trained home visitors recruited from the community to meet the
needs of defined target service populations;
and
(C) make further recommendations necessary or desirable to increase the effectiveness of such projects.
(q) Definitions
For purposes of this section:
(1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide
health or related social services, including
community-based
organizations,
visiting
nurse organizations, hospitals, local health departments, community health centers, Native
Hawaiian health centers, nurse managed clinics, family service agencies, child welfare
agencies, developmental service providers,
family resource and support programs, and resource mothers projects.
(2) The term ‘‘eligible family’’ means a family described in subsection (a) of this section.
(3) The term ‘‘health or developmental complication’’, with respect to a child, means—
(A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low birthweight, and prenatal
exposure to maternal substance abuse;
(B) a condition arising from a condition
described in subparagraph (A);
(C) a physical disability or delay; and
(D) a developmental disability or delay.
(4) The term ‘‘home visiting services’’ means
the services specified in subsection (b) of this
section, provided at the residence of the eligible family involved or provided pursuant to arrangements made for the family (including arrangements for services in community settings).
(5) The term ‘‘home visitors’’ means providers of home visiting services.
(r) Authorization of appropriations
For the purpose of carrying out this section,
there is authorized to be appropriated $30,000,000
for each of the fiscal years 1993 and 1994.
(July 1, 1944, ch. 373, title III, § 399, as added Pub.
L. 102–321, title V, § 502(2), July 10, 1992, 106 Stat.
427; amended Pub. L. 103–448, title II,
§ 204(w)(2)(D), Nov. 2, 1994, 108 Stat. 4746; Pub. L.

§ 280c–6

108–446, title III, § 305(i)(2), Dec. 3, 2004, 118 Stat.
2806.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs.
(a)(3)(A), (b)(6), and (m)(7), is act Aug. 14, 1935, ch. 531,
49 Stat. 620, as amended. Titles IV, V, and XIX of the
Act are classified generally to subchapters IV (§ 601 et
seq.), V (§ 701 et seq.), and XIX (§ 1396 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.
The Individuals with Disabilities Education Act, referred to in subsec. (n)(3), is title VI of Pub. L. 91–230,
Apr. 13, 1970, 84 Stat. 175, as amended. Part C of the Act
is classified generally to subchapter III (§ 1431 et seq.) of
chapter 33 of Title 20, Education. For complete classification of this Act to the Code, see section 1400 of Title
20 and Tables.
PRIOR PROVISIONS
A prior section 399 of act July 1, 1944, was renumbered
section 398A by section 502(1) of Pub. L. 102–321 and is
classified to section 280c–4 of this title.
Another prior section 399 of act July 1, 1944, ch. 373,
title III, formerly § 399b, as added Oct. 22, 1965, Pub. L.
89–291, § 2, 79 Stat. 1066; renumbered § 399a and amended
Mar. 13, 1970, Pub. L. 91–212, § 10(c)(3), (d)(2)(A), 84 Stat.
67; renumbered § 399, July 23, 1974, Pub. L. 93–353, title
II, § 204, 88 Stat. 373; Oct. 17, 1979, Pub. L. 96–88, title V,
§ 509(b), 93 Stat. 695, which related to the maintenance
of records by recipients of grants and audits thereof by
the Secretary of Health and Human Services and the
Comptroller General of the United States, was classified to section 280b–11 of this title, prior to repeal by
Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.
AMENDMENTS
2004—Subsec. (n)(3). Pub. L. 108–446 substituted ‘‘part
C’’ for ‘‘part H’’.
1994—Subsec. (b)(6). Pub. L. 103–448 substituted ‘‘special supplemental nutrition program’’ for ‘‘special supplemental food program’’.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103–448 effective Oct. 1, 1994,
see section 401 of Pub. L. 103–448, set out as a note
under section 1755 of this title.
EFFECTIVE DATE
Section effective July 10, 1992, with programs making
awards providing financial assistance in fiscal year 1993
and subsequent years effective for awards made on or
after Oct. 1, 1992, see section 801(b), (d)(1) of Pub. L.
102–321, set out as an Effective Date of 1992 Amendment
note under section 236 of this title.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
PURPOSE
Section 501 of title V of Pub. L. 102–321 provided that:
‘‘The purpose of this title [enacting this section] is—
‘‘(1) to increase the use of, and to provide information on the availability of early, continuous and comprehensive prenatal care;
‘‘(2) to reduce the incidence of infant mortality and
of infants born prematurely, with low birthweight, or
with other impairments including those associated
with maternal substance abuse;
‘‘(3) for pregnant women and mothers of children
below the age of 3 whose children have experienced or

§ 280d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

are at risk of experiencing a health or developmental
complication, to provide assistance in obtaining
health and related social services necessary to meet
the special needs of the women and their children;
‘‘(4) to assist, when requested, women who are pregnant and at-risk for poor birth outcomes, or who have
young children and are abusing alcohol or other
drugs, in obtaining appropriate treatment; and
‘‘(5) to reduce the incidence of child abuse and neglect.’’

PART L—[REPEALED]
AMENDMENTS
2000—Pub. L. 106–310, div. B, title XXXI, § 3106(n), Oct.
17, 2000, 114 Stat. 1179, struck out heading for part L
‘‘Services for Children of Substance Abusers’’.
1993—Pub. L. 103–43, title XX, § 2008(i)(2)(B)(ii), June
10, 1993, 107 Stat. 213, redesignated part M ‘‘Services for
Children of Substance Abusers’’ as L. Former part L
‘‘Health Care Services in the Home’’ redesignated K.
1990—Pub. L. 101–616, title I, § 101(a)(1), Nov. 16, 1990,
104 Stat. 3279, redesignated part K ‘‘Health Care Services in the Home’’ as L.

§ 280d. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title III, § 399D, as
added Pub. L. 102–321, title IV, § 401(a), July 10, 1992, 106
Stat. 419, and amended, which related to grants for
services for children of substance abusers, was renumbered section 399A of title III of act July 1, 1944 by Pub.
L. 106–310, div. A, title V, § 502(1), Oct. 17, 2000, 114 Stat.
1115. Subsequently, section 399D was renumbered section 519 of title V of act July 1, 1944, without reference
to its prior renumbering as 399A, by Pub. L. 106–310, div.
B, title XXXI, § 3106(m), Oct. 17, 2000, 114 Stat. 1179. Section was transferred to section 290bb–25 of this title.

§ 280d–11. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title III, § 399F, as
added Pub. L. 102–531, title II, § 201, Oct. 27, 1992, 106
Stat. 3474, which comprised part N in its entirety and
which related to establishment and duties of National
Foundation for the Centers for Disease Control and
Prevention, was renumbered section 399G of act July 1,
1944, by Pub. L. 106–310, div. A, title V, § 502(3), Oct. 17,
2000, 114 Stat. 1115, and transferred to section 280e–11 of
this title.

PART M—NATIONAL PROGRAM OF CANCER
REGISTRIES
§ 280e. National program of cancer registries
(a) In general
(1) Statewide cancer registries
The Secretary, acting through the Director
of the Centers for Disease Control, may make
grants to States, or may make grants or enter
into contracts with academic or nonprofit organizations designated by the State to operate
the State’s cancer registry in lieu of making a
grant directly to the State, to support the operation of population-based, statewide registries to collect, for each condition specified
in paragraph (2)(A), data concerning—
(A) demographic information about each
case of cancer;
(B) information on the industrial or occupational history of the individuals with the
cancers, to the extent such information is
available from the same record;

Page 434

(C) administrative information, including
date of diagnosis and source of information;
(D) pathological data characterizing the
cancer, including the cancer site, stage of
disease (pursuant to Staging Guide), incidence, and type of treatment; and
(E) other elements determined appropriate
by the Secretary.
(2) Cancer; benign brain-related tumors
(A) In general
For purposes of paragraph (1), the conditions referred to in this paragraph are the
following:
(i) Each form of in-situ and invasive cancer (with the exception of basal cell and
squamous cell carcinoma of the skin), including malignant brain-related tumors.
(ii) Benign brain-related tumors.
(B) Brain-related tumor
For purposes of subparagraph (A):
(i) The term ‘‘brain-related tumor’’
means a listed primary tumor (whether
malignant or benign) occurring in any of
the following sites:
(I) The brain, meninges, spinal cord,
cauda equina, a cranial nerve or nerves,
or any other part of the central nervous
system.
(II) The pituitary gland, pineal gland,
or craniopharyngeal duct.
(ii) The term ‘‘listed’’, with respect to a
primary tumor, means a primary tumor
that is listed in the International Classification of Diseases for Oncology (commonly referred to as the ICD–O).
(iii) The term ‘‘International Classification of Diseases for Oncology’’ means a
classification system that includes topography (site) information and histology
(cell type information) developed by the
World Health Organization, in collaboration with international centers, to promote international comparability in the
collection, classification, processing, and
presentation of cancer statistics. The
ICD–O system is a supplement to the International Statistical Classification of Diseases and Related Health Problems (commonly known as the ICD) and is the standard coding system used by cancer registries worldwide. Such term includes any
modification made to such system for purposes of the United States. Such term further includes any published classification
system that is internationally recognized
as a successor to the classification system
referred to in the first sentence of this
clause.
(C) Statewide cancer registry
References in this section to cancer registries shall be considered to be references to
registries described in this subsection.
(b) Matching funds
(1) In general
The Secretary may make a grant under subsection (a) of this section only if the State, or
the academic or nonprofit private organiza-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion designated by the State to operate the
cancer registry of the State, involved agrees,
with respect to the costs of the program, to
make available (directly or through donations
from public or private entities) non-Federal
contributions toward such costs in an amount
that is not less than 25 percent of such costs or
$1 for every $3 of Federal funds provided in the
grant.
(2) Determination of amount of non-Federal
contribution; maintenance of effort
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to
any significant extent by the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
(B) With respect to a State in which the purpose described in subsection (a) of this section
is to be carried out, the Secretary, in making
a determination of the amount of non-Federal
contributions provided under paragraph (1),
may include only such contributions as are in
excess of the amount of such contributions
made by the State toward the collection of
data on cancer for the fiscal year preceding
the first year for which a grant under subsection (a) of this section is made with respect
to the State. The Secretary may decrease the
amount of non-Federal contributions that
otherwise would have been required by this
subsection in those cases in which the State
can demonstrate that decreasing such amount
is appropriate because of financial hardship.
(c) Eligibility for grants
(1) In general
No grant shall be made by the Secretary
under subsection (a) of this section unless an
application has been submitted to, and approved by, the Secretary. Such application
shall be in such form, submitted in such a
manner, and be accompanied by such information, as the Secretary may specify. No such
application may be approved unless it contains assurances that the applicant will use
the funds provided only for the purposes specified in the approved application and in accordance with the requirements of this section,
that the application will establish such fiscal
control and fund accounting procedures as
may be necessary to assure proper disbursement and accounting of Federal funds paid to
the applicant under subsection (a) of this section, and that the applicant will comply with
the peer review requirements under sections
289 and 289a of this title.
(2) Assurances
Each applicant, prior to receiving Federal
funds under subsection (a) of this section,
shall provide assurances satisfactory to the
Secretary that the applicant will—
(A) provide for the establishment of a registry in accordance with subsection (a) of
this section;
(B) comply with appropriate standards of
completeness, timeliness, and quality of population-based cancer registry data;

§ 280e

(C) provide for the annual publication of
reports of cancer data under subsection (a)
of this section; and
(D) provide for the authorization under
State law of the statewide cancer registry,
including promulgation of regulations providing—
(i) a means to assure complete reporting
of cancer cases (as described in subsection
(a) of this section) to the statewide cancer
registry by hospitals or other facilities
providing screening, diagnostic or therapeutic services to patients with respect to
cancer;
(ii) a means to assure the complete reporting of cancer cases (as defined in subsection (a) of this section) to the statewide
cancer registry by physicians, surgeons,
and all other health care practitioners diagnosing or providing treatment for cancer patients, except for cases directly referred to or previously admitted to a hospital or other facility providing screening,
diagnostic or therapeutic services to patients in that State and reported by those
facilities;
(iii) a means for the statewide cancer
registry to access all records of physicians
and surgeons, hospitals, outpatient clinics,
nursing homes, and all other facilities, individuals, or agencies providing such services to patients which would identify cases
of cancer or would establish characteristics of the cancer, treatment of the cancer,
or medical status of any identified patient;
(iv) for the reporting of cancer case data
to the statewide cancer registry in such a
format, with such data elements, and in
accordance with such standards of quality
timeliness and completeness, as may be established by the Secretary;
(v) for the protection of the confidentiality of all cancer case data reported to the
statewide cancer registry, including a prohibition on disclosure to any person of information reported to the statewide cancer
registry that identifies, or could lead to
the identification of, an individual cancer
patient, except for disclosure to other
State cancer registries and local and State
health officers;
(vi) for a means by which confidential
case data may in accordance with State
law be disclosed to cancer researchers for
the purposes of cancer prevention, control
and research;
(vii) for the authorization or the conduct, by the statewide cancer registry or
other persons and organizations, of studies
utilizing statewide cancer registry data,
including studies of the sources and causes
of cancer, evaluations of the cost, quality,
efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and
preventative services and programs relating to cancer, and any other clinical, epidemiological, or other cancer research;
and
(viii) for protection for individuals complying with the law, including provisions
specifying that no person shall be held lia-

§ 280e–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ble in any civil action with respect to a
cancer case report provided to the statewide cancer registry, or with respect to access to cancer case information provided
to the statewide cancer registry.
(d) Relationship to certain programs
(1) In general
This section may not be construed to act as
a replacement for or diminishment of the program carried out by the Director of the National Cancer Institute and designated by such
Director as the Surveillance, Epidemiology,
and End Results Program (SEER).
(2) Supplanting of activities
In areas where both such programs exist, the
Secretary shall ensure that SEER support is
not supplanted and that any additional activities are consistent with the guidelines provided for in subsection (c)(2)(C) and (D) of this
section and are appropriately coordinated
with the existing SEER program.
(3) Transfer of responsibility
The Secretary may not transfer administration responsibility for such SEER program
from such Director.
(4) Coordination
To encourage the greatest possible efficiency
and effectiveness of Federally supported efforts with respect to the activities described
in this subsection, the Secretary shall take
steps to assure the appropriate coordination of
programs supported under this part with existing Federally supported cancer registry programs.
(e) Requirement regarding certain study on
breast cancer
In the case of a grant under subsection (a) of
this section to any State specified in subsection
(b) of section 280e–3 of this title, the Secretary
may establish such conditions regarding the receipt of the grant as the Secretary determines
are necessary to facilitate the collection of data
for the study carried out under such section.
(July 1, 1944, ch. 373, title III, § 399B, formerly
§ 399H, as added Pub. L. 102–515, § 3, Oct. 24, 1992,
106 Stat. 3372; renumbered § 399B and amended
Pub. L. 106–310, div. A, title V, § 502(2)(A), (B),
Oct. 17, 2000, 114 Stat. 1115; Pub. L. 107–260, § 2(a),
Oct. 29, 2002, 116 Stat. 1743.)
AMENDMENTS
2002—Subsec. (a). Pub. L. 107–260 designated existing
provisions as par. (1), inserted par. (1) heading, substituted ‘‘population-based, statewide registries to collect, for each condition specified in paragraph (2)(A),
data’’ for ‘‘population-based, statewide cancer registries in order to collect, for each form of in-situ and
invasive cancer (with the exception of basal cell and
squamous cell carcinoma of the skin), data’’, redesignated former pars. (1) to (5) as subpars. (A) to (E) of
par. (1), respectively, and added par. (2).
2000—Subsec. (e). Pub. L. 106–310, § 502(2)(B), substituted ‘‘subsection (b) of section 280e–3 of this title’’
for ‘‘section 280e–3(b) of this title’’ and ‘‘such section’’
for ‘‘section 399C’’.
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.

Page 436

EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107–260, § 2(b), Oct. 29, 2002, 116 Stat. 1744, provided that: ‘‘The amendments made by subsection (a)
[amending this section] apply to grants under section
399B of the Public Health Service Act [this section] for
fiscal year 2002 and subsequent fiscal years, except
that, in the case of a State that received such a grant
for fiscal year 2000, the Secretary of Health and Human
Services may delay the applicability of such amendments to the State for not more than 12 months if the
Secretary determines that compliance with such
amendments requires the enactment of a statute by the
State or the issuance of State regulations.’’
CONGRESSIONAL FINDINGS AND PURPOSE
Section 2 of Pub. L. 102–515 provided that:
‘‘(a) FINDINGS.—Congress finds that—
‘‘(1) cancer control efforts, including prevention
and early detection, are best addressed locally by
State health departments that can identify unique
needs;
‘‘(2) cancer control programs and existing statewide
population-based cancer registries have identified
cancer incidence and cancer mortality rates that indicate the burden of cancer for Americans is substantial and varies widely by geographic location and by
ethnicity;
‘‘(3) statewide cancer incidence and cancer mortality data, can be used to identify cancer trends, patterns, and variation for directing cancer control
intervention;
‘‘(4) the American Association of Central Cancer
Registries (AACCR) cites that of the 50 States, approximately 38 have established cancer registries,
many are not statewide and 10 have no cancer registry; and
‘‘(5) AACCR also cites that of the 50 States, 39 collect data on less than 100 percent of their population,
and less than half have adequate resources for insuring minimum standards for quality and for completeness of case information.
‘‘(b) PURPOSE.—It is the purpose of this Act [enacting
this part and provisions set out as a note under section
201 of this title] to establish a national program of cancer registries.’’

§ 280e–1. Planning grants regarding registries
(a) In general
(1) States
The Secretary, acting through the Director
of the Centers for Disease Control, may make
grants to States for the purpose of developing
plans that meet the assurances required by the
Secretary under section 280e(c)(2) of this title.
(2) Other entities
For the purpose described in paragraph (1),
the Secretary may make grants to public entities other than States and to nonprofit private
entities. Such a grant may be made to an entity only if the State in which the purpose is
to be carried out has certified that the State
approves the entity as qualified to carry out
the purpose.
(b) Application
The Secretary may make a grant under subsection (a) of this section only if an application
for the grant is submitted to the Secretary, the
application contains the certification required
in subsection (a)(2) of this section (if the application is for a grant under such subsection), and
the application is in such form, is made in such
manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

Page 437

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title III, § 399C, formerly
§ 399I, as added Pub. L. 102–515, § 3, Oct. 24, 1992,
106 Stat. 3375; renumbered § 399C, Pub. L. 106–310,
div. A, title V, § 502(2)(A), Oct. 17, 2000, 114 Stat.
1115.)
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.

§ 280e–2. Technical assistance in operations of
statewide cancer registries
The Secretary, acting through the Director of
the Centers for Disease Control, may, directly or
through grants and contracts, or both, provide
technical assistance to the States in the establishment and operation of statewide registries,
including assistance in the development of
model legislation for statewide cancer registries
and assistance in establishing a computerized
reporting and data processing system.
(July 1, 1944, ch. 373, title III, § 399D, formerly
§ 399J, as added Pub. L. 102–515, § 3, Oct. 24, 1992,
106 Stat. 3376; renumbered § 399D, Pub. L. 106–310,
div. A, title V, § 502(2)(A), Oct. 17, 2000, 114 Stat.
1115.)
PRIOR PROVISIONS
A prior section 399D of act July 1, 1944, was renumbered section 519, and is classified to section 290bb–25 of
this title.
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.

§ 280e–3. Study in certain States to determine
factors contributing to elevated breast cancer mortality rates
(a) In general
Subject to subsections (c) and (d) of this section, the Secretary, acting through the Director
of the National Cancer Institute, shall conduct a
study for the purpose of determining the factors
contributing to the fact that breast cancer mortality rates in the States specified in subsection
(b) of this section are elevated compared to
rates in other States.
(b) Relevant States
The States referred to in subsection (a) of this
section are Connecticut, Delaware, Maryland,
Massachusetts, New Hampshire, New Jersey,
New York, Rhode Island, Vermont, and the District of Columbia.
(c) Cooperation of State
The Secretary may conduct the study required
in subsection (a) of this section in a State only
if the State agrees to cooperate with the Secretary in the conduct of the study, including
providing information from any registry operated by the State pursuant to section 280e(a) of
this title.
(d) Planning, commencement, and duration
The Secretary shall, during each of the fiscal
years 1993 and 1994, develop a plan for conducting the study required in subsection (a) of this
section. The study shall be initiated by the Sec-

§ 280e–3a

retary not later than fiscal year 1994, and the
collection of data under the study may continue
through fiscal year 1998.
(July 1, 1944, ch. 373, title III, § 399E, formerly
§ 399K, as added Pub. L. 102–515, § 3, Oct. 24, 1992,
106 Stat. 3376; renumbered § 399E and amended
Pub. L. 106–310, div. A, title V, § 502(2)(A), (C),
Oct. 17, 2000, 114 Stat. 1115; Pub. L. 109–482, title
I, § 104(b)(2)(A), Jan. 15, 2007, 120 Stat. 3693.)
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘Not later
than September 30, 1999, the Secretary shall complete
the study required in subsection (a) of this section and
submit to the Committee on Energy and Commerce of
the House of Representatives, and to the Committee on
Labor and Human Resources of the Senate, a report describing the findings and recommendations made as a
result of the study.’’
2000—Subsec. (c). Pub. L. 106–310, § 502(2)(C), made
technical amendment to reference in original act which
appears in text as reference to section 280e(a) of this
title.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
POTENTIAL ENVIRONMENTAL AND OTHER RISKS
CONTRIBUTING TO INCIDENCE OF BREAST CANCER
Pub. L. 103–43, title XIX, § 1911, June 10, 1993, 107 Stat.
205, provided that Director of the National Cancer Institute, in collaboration with Director of the National
Institute of Environmental Health Sciences, was to
conduct case-control study to assess biological markers
of environmental and other potential risk factors contributing to incidence of breast cancer in specified
counties in State of New York and northeastern United
States that had highest age-adjusted mortality rate of
such cancer, and to report results of such study to Congress not later than 30 months after June 10, 1993.

§ 280e–3a. National childhood cancer registry
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall award a grant to enhance and expand infrastructure to track the epidemiology of pediatric
cancer into a comprehensive nationwide registry
of actual occurrences of pediatric cancer. Such
registry shall be updated to include an actual
occurrence within weeks of the date of such occurrence.
(b) Informed consent and privacy requirements
and coordination with existing programs
The registry established pursuant to subsection (a) shall be subject to section 552a of
title 5, the regulations promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996, applicable Federal and State informed consent regulations,
any other applicable Federal and State laws relating to the privacy of patient information, and
section 280e(d)(4) of this title.
(July 1, 1944, ch. 373, title III, § 399E–1, as added
Pub. L. 110–285, § 4(b)(1), July 29, 2008, 122 Stat.
2630.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (b), is

§ 280e–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section 264(c) of Pub. L. 104–191, which is set out as a
note under section 1320d–2 of this title.
FINDINGS AND PURPOSES
Pub. L. 110–285, §§ 2, 3, July 29, 2008, 122 Stat. 2628, provided that:
‘‘SEC. 2. FINDINGS
‘‘Congress makes the following findings:
‘‘(1) Cancer kills more children than any other disease.
‘‘(2) Each year cancer kills more children between
1 and 20 years of age than asthma, diabetes, cystic fibrosis, and AIDS, combined.
‘‘(3) Every year, over 12,500 young people are diagnosed with cancer.
‘‘(4) Each year about 2,300 children and teenagers
die from cancer.
‘‘(5) One in every 330 Americans develops cancer before age 20.
‘‘(6) Some forms of childhood cancer have proven to
be so resistant that even in spite of the great research strides made, most of those children die. Up to
75 percent of the children with cancer can now be
cured.
‘‘(7) The causes of most childhood cancers are not
yet known.
‘‘(8) Childhood cancers are mostly those of the
white blood cells (leukemias), brain, bone, the lymphatic system, and tumors of the muscles, kidneys,
and nervous system. Each of these behaves differently, but all are characterized by an uncontrolled
proliferation of abnormal cells.
‘‘(9) Eighty percent of the children who are diagnosed with cancer have disease which has already
spread to distant sites in the body.
‘‘(10) Ninety percent of children with a form of pediatric cancer are treated at one of the more than 200
Children’s Oncology Group member institutions
throughout the United States.
‘‘SEC. 3. PURPOSES
‘‘It is the purpose of this Act [see Short Title of 2008
Amendment note set out under section 201 of this title]
to authorize appropriations to—
‘‘(1) encourage the support for pediatric cancer research and other activities related to pediatric cancer;
‘‘(2) establish a comprehensive national childhood
cancer registry; and
‘‘(3) provide informational services to patients and
families affected by childhood cancer.’’

Page 438

(July 1, 1944, ch. 373, title III, § 399F, formerly
§ 399L, as added Pub. L. 102–515, § 3, Oct. 24, 1992,
106 Stat. 3376; amended Pub. L. 103–43, title XX,
§ 2003, June 10, 1993, 107 Stat. 208; Pub. L. 103–183,
title VII, § 705(c), Dec. 14, 1993, 107 Stat. 2241;
Pub. L. 105–340, title II, § 202, Oct. 31, 1998, 112
Stat. 3194; renumbered § 399F and amended Pub.
L. 106–310, div. A, title V, § 502(2)(A), (D), Oct. 17,
2000, 114 Stat. 1115; Pub. L. 110–285, § 4(b)(2), July
29, 2008, 122 Stat. 2631.)
PRIOR PROVISIONS
A prior section 399F of act July 1, 1944, was renumbered section 399G and is classified to section 280e–11 of
this title.
AMENDMENTS
2008—Subsec. (a). Pub. L. 110–285 inserted ‘‘(other
than section 280e–3a of this title)’’ after ‘‘this part’’.
2000—Subsec. (a). Pub. L. 106–310, § 502(2)(D)(ii), substituted ‘‘section 280e–2 of this title’’ for ‘‘subsection
280e–2 of this title’’.
Pub. L. 106–310, § 502(2)(D)(i), made technical amendment to reference in original act which appears in text
as reference to section 280e–1 of this title.
Subsec. (b). Pub. L. 106–310, § 502(2)(D)(iii), made technical amendment to reference in original act which appears in text as reference to section 280e–3 of this title.
1998—Subsec. (a). Pub. L. 105–340 substituted ‘‘2003’’
for ‘‘1998’’.
1993—Subsec. (a). Pub. L. 103–183 substituted
‘‘through 1998’’ for ‘‘through 1996’’.
Pub. L. 103–43 substituted ‘‘there are authorized to be
appropriated $30,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years
1995 through 1996’’ for ‘‘the Secretary may use
$30,000,000 for each of the fiscal years 1993 through 1997’’
in first sentence and ‘‘Of the amounts appropriated
under the preceding sentence’’ for ‘‘Out of any amounts
used’’ in second sentence.

PART N—NATIONAL FOUNDATION FOR THE CENTERS FOR DISEASE CONTROL AND PREVENTION
CODIFICATION
This part was formerly set out preceding part M of
this subchapter.

§ 280e–4. Authorization of appropriations

§ 280e–11. Establishment and duties of Foundation

(a) Registries
For the purpose of carrying out this part
(other than section 280e–3a of this title), there
are authorized to be appropriated $30,000,000 for
fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through
2003. Of the amounts appropriated under the preceding sentence for any such fiscal year, the
Secretary may obligate not more than 25 percent for carrying out section 280e–1 of this title,
and not more than 10 percent may be expended
for assessing the accuracy, completeness and
quality of data collected, and not more than 10
percent of which is to be expended under section
280e–2 of this title.
(b) Breast cancer study
Of the amounts appropriated for the National
Cancer Institute under subpart 1 of part C of
subchapter III of this chapter for any fiscal year
in which the study required in section 280e–3 of
this title is being carried out, the Secretary
shall expend not less than $1,000,000 for the
study.

(a) In general
There shall be established in accordance with
this section a nonprofit private corporation to
be known as the National Foundation for the
Centers for Disease Control and Prevention (in
this part referred to as the ‘‘Foundation’’). The
Foundation shall not be an agency or instrumentality of the Federal Government, and officers, employees, and members of the board of
the Foundation shall not be officers or employees of the Federal Government.
(b) Purpose of Foundation
The purpose of the Foundation shall be to support and carry out activities for the prevention
and control of diseases, disorders, injuries, and
disabilities, and for promotion of public health.
(c) Endowment fund
(1) In general
In carrying out subsection (b) of this section, the Foundation shall establish a fund for
providing endowments for positions that are
associated with the Centers for Disease Con-

Page 439

TITLE 42—THE PUBLIC HEALTH AND WELFARE

trol and Prevention and dedicated to the purpose described in such subsection. Subject to
subsection (f)(1)(B) of this section, the fund
shall consist of such donations as may be provided by non-Federal entities and such nonFederal assets of the Foundation (including
earnings of the Foundation and the fund) as
the Foundation may elect to transfer to the
fund.
(2) Authorized expenditures of fund
The provision of endowments under paragraph (1) shall be the exclusive function of the
fund established under such paragraph. Such
endowments may be expended only for the
compensation of individuals holding the positions, for staff, equipment, quarters, travel,
and other expenditures that are appropriate in
supporting the positions, and for recruiting individuals to hold the positions endowed by the
fund.
(d) Certain activities of Foundation
In carrying out subsection (b) of this section,
the Foundation may provide for the following
with respect to the purpose described in such
subsection:
(1) Programs of fellowships for State and
local public health officials to work and study
in association with the Centers for Disease
Control and Prevention.
(2) Programs of international arrangements
to provide opportunities for public health officials of other countries to serve in public
health capacities in the United States in association with the Centers for Disease Control
and Prevention or elsewhere, or opportunities
for employees of such Centers (or other public
health officials in the United States) to serve
in such capacities in other countries, or both.
(3) Studies, projects, and research (which
may include applied research on the effectiveness of prevention activities, demonstration
projects, and programs and projects involving
international, Federal, State, and local governments).
(4) Forums for government officials and appropriate private entities to exchange information. Participants in such forums may include institutions of higher education and appropriate international organizations.
(5) Meetings, conferences, courses, and training workshops.
(6) Programs to improve the collection and
analysis of data on the health status of various populations.
(7) Programs for writing, editing, printing,
and publishing of books and other materials.
(8) Other activities to carry out the purpose
described in subsection (b) of this section.
(e) General structure of Foundation; nonprofit
status
(1) Board of directors
The Foundation shall have a board of directors (in this part referred to as the ‘‘Board’’),
which shall be established and conducted in
accordance with subsection (f) of this section.
The Board shall establish the general policies
of the Foundation for carrying out subsection
(b) of this section, including the establishment
of the bylaws of the Foundation.

§ 280e–11

(2) Executive director
The Foundation shall have an executive director (in this part referred to as the ‘‘Director’’), who shall be appointed by the Board,
who shall serve at the pleasure of the Board,
and for whom the Board shall establish the
rate of compensation. Subject to compliance
with the policies and bylaws established by
the Board pursuant to paragraph (1), the Director shall be responsible for the daily operations of the Foundation in carrying out subsection (b) of this section.
(3) Nonprofit status
In carrying out subsection (b) of this section, the Board shall establish such policies
and bylaws under paragraph (1), and the Director shall carry out such activities under paragraph (2), as may be necessary to ensure that
the Foundation maintains status as an organization that—
(A) is described in subsection (c)(3) of section 501 of title 26; and
(B) is, under subsection (a) of such section,
exempt from taxation.
(f) Board of directors
(1) Certain bylaws
(A) In establishing bylaws under subsection
(e)(1) of this section, the Board shall ensure
that the bylaws of the Foundation include bylaws for the following:
(i) Policies for the selection of the officers,
employees, agents, and contractors of the
Foundation.
(ii) Policies, including ethical standards,
for the acceptance and disposition of donations to the Foundation and for the disposition of the assets of the Foundation.
(iii) Policies for the conduct of the general
operations of the Foundation.
(iv) Policies for writing, editing, printing,
and publishing of books and other materials,
and the acquisition of patents and licenses
for devices and procedures developed by the
Foundation.
(B) In establishing bylaws under subsection
(e)(1) of this section, the Board shall ensure
that the bylaws of the Foundation (and activities carried out under the bylaws) do not—
(i) reflect unfavorably upon the ability of
the Foundation, or the Centers for Disease
Control and Prevention, to carry out its responsibilities or official duties in a fair and
objective manner; or
(ii) compromise, or appear to compromise,
the integrity of any governmental program
or any officer or employee involved in such
program.
(2) Composition
(A) Subject to subparagraph (B), the Board
shall be composed of 7 individuals, appointed
in accordance with paragraph (4), who collectively possess education or experience appropriate for representing the general field of
public health, the general field of international health, and the general public. Each
such individual shall be a voting member of
the Board.
(B) The Board may, through amendments to
the bylaws of the Foundation, provide that the

§ 280e–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

number of members of the Board shall be a
greater number than the number specified in
subparagraph (A).
(3) Chair
The Board shall, from among the members
of the Board, designate an individual to serve
as the chair of the Board (in this subsection
referred to as the ‘‘Chair’’).
(4) Appointments, vacancies, and terms
Subject to subsection (j) of this section (regarding the initial membership of the Board),
the following shall apply to the Board:
(A) Any vacancy in the membership of the
Board shall be filled by appointment by the
Board, after consideration of suggestions
made by the Chair and the Director regarding the appointments. Any such vacancy
shall be filled not later than the expiration
of the 180-day period beginning on the date
on which the vacancy occurs.
(B) The term of office of each member of
the Board appointed under subparagraph (A)
shall be 5 years. A member of the Board may
continue to serve after the expiration of the
term of the member until the expiration of
the 180-day period beginning on the date on
which the term of the member expires.
(C) A vacancy in the membership of the
Board shall not affect the power of the Board
to carry out the duties of the Board. If a
member of the Board does not serve the full
term applicable under subparagraph (B), the
individual appointed to fill the resulting vacancy shall be appointed for the remainder
of the term of the predecessor of the individual.
(5) Compensation
Members of the Board may not receive compensation for service on the Board. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in
carrying out the duties of the Board.
(g) Certain responsibilities of executive director
In carrying out subsection (e)(2) of this section, the Director shall carry out the following
functions:
(1) Hire, promote, compensate, and discharge
officers and employees of the Foundation, and
define the duties of the officers and employees.
(2) Accept and administer donations to the
Foundation, and administer the assets of the
Foundation.
(3) Establish a process for the selection of
candidates for holding endowed positions
under subsection (c) of this section.
(4) Enter into such financial agreements as
are appropriate in carrying out the activities
of the Foundation.
(5) Take such action as may be necessary to
acquire patents and licenses for devices and
procedures developed by the Foundation and
the employees of the Foundation.
(6) Adopt, alter, and use a corporate seal,
which shall be judicially noticed.
(7) Commence and respond to judicial proceedings in the name of the Foundation.
(8) Other functions that are appropriate in
the determination of the Director.

Page 440

(h) General provisions
(1) Authority for accepting funds
The Director of the Centers for Disease Control and Prevention may accept and utilize, on
behalf of the Federal Government, any gift,
donation, bequest, or devise of real or personal
property from the Foundation for the purpose
of aiding or facilitating the work of such Centers. Funds may be accepted and utilized by
such Director under the preceding sentence
without regard to whether the funds are designated as general-purpose funds or specialpurpose funds.
(2) Authority for acceptance of voluntary services
(A) The Director of the Centers for Disease
Control and Prevention may accept, on behalf
of the Federal Government, any voluntary
services provided to such Centers by the Foundation for the purpose of aiding or facilitating
the work of such Centers. In the case of an individual, such Director may accept the services provided under the preceding sentence by
the individual until such time as the private
funding for such individual ends.
(B) The limitation established in subparagraph (A) regarding the period of time in
which services may be accepted applies to
each individual who is not an employee of the
Federal Government and who serves in association with the Centers for Disease Control
and Prevention pursuant to financial support
from the Foundation.
(3) Administrative control
No officer, employee, or member of the
Board of the Foundation may exercise any administrative or managerial control over any
Federal employee.
(4) Applicability of certain standards to nonFederal employees
In the case of any individual who is not an
employee of the Federal Government and who
serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation, the
Foundation shall negotiate a memorandum of
understanding with the individual and the Director of the Centers for Disease Control and
Prevention specifying that the individual—
(A) shall be subject to the ethical and procedural standards regulating Federal employment, scientific investigation, and research findings (including publications and
patents) that are required of individuals employed by the Centers for Disease Control
and Prevention, including standards under
this chapter, the Ethics in Government Act,
and the Technology Transfer Act; 1 and
(B) shall be subject to such ethical and
procedural standards under chapter 11 of
title 18 (relating to conflicts of interest), as
the Director of such Centers determines is
appropriate, except such memorandum may
not provide that the individual shall be subject to the standards of section 209 of title
18.
1 See

References in Text note below.

Page 441

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Financial conflicts of interest
Any individual who is an officer, employee,
or member of the Board of the Foundation
may not directly or indirectly participate in
the consideration or determination by the
Foundation of any question affecting—
(A) any direct or indirect financial interest of the individual; or
(B) any direct or indirect financial interest
of any business organization or other entity
of which the individual is an officer or employee or in which the individual has a direct or indirect financial interest.
(6) Audits; availability of records
The Foundation shall—
(A) provide for biennial audits of the financial condition of the Foundation; and
(B) make such audits, and all other
records, documents, and other papers of the
Foundation, available to the Secretary and
the Comptroller General of the United
States for examination or audit.
(7) Reports
(A) Not later than February 1 of each fiscal
year, the Foundation shall publish a report describing the activities of the Foundation during the preceding fiscal year. Each such report
shall include for the fiscal year involved a
comprehensive statement of the operations,
activities, financial condition, and accomplishments of the Foundation, including an accounting of the use of amounts provided for
under subsection (i).
(B) With respect to the financial condition of
the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts to the Foundation of real
or personal property, and the source and
amount of all gifts to the Foundation of
money. Each such report shall include a specification of any restrictions on the purposes for
which gifts to the Foundation may be used.
(C) The Foundation shall make copies of
each report submitted under subparagraph (A)
available—
(i) for public inspection, and shall upon request provide a copy of the report to any individual for a charge not to exceed the cost
of providing the copy; and
(ii) to the appropriate committees of Congress.
(8) Liaison from Centers for Disease Control
and Prevention
The Director of the Centers for Disease Control and Prevention shall serve as the liaison
representative of such Centers to the Board
and the Foundation.
(i) Federal funding
(1) Authority for annual grants
(A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(i) for fiscal year 1993, make a grant to an
entity described in subsection (j)(9) of this
section (relating to the establishment of a
committee to establish the Foundation);
(ii) for fiscal year 1994, make a grant to the
committee established under such sub-

§ 280e–11

section, or if the Foundation has been established, to the Foundation; and
(iii) for fiscal year 1995 and each subsequent fiscal year, make a grant to the Foundation.
(B) A grant under subparagraph (A) may be
expended—
(i) in the case of an entity receiving the
grant under subparagraph (A)(i), only for the
purpose of carrying out the duties established in subsection (j)(9) of this section for
the entity;
(ii) in the case of the committee established under such subsection, only for the
purpose of carrying out the duties established in subsection (j) of this section for the
committee; and
(iii) in the case of the Foundation, only for
the purpose of the administrative expenses
of the Foundation.
(C) A grant under subparagraph (A) may not
be expended to provide amounts for the fund
established under subsection (c) of this section.
(D) For the purposes described in subparagraph (B)—
(i) any portion of the grant made under
subparagraph (A)(i) for fiscal year 1993 that
remains unobligated after the entity receiving the grant completes the duties established in subsection (j)(9) of this section for
the entity shall be available to the committee established under such subsection; and
(ii) any portion of a grant under subparagraph (A) made for fiscal year 1993 or 1994
that remains unobligated after such committee completes the duties established in
such subsection for the committee shall be
available to the Foundation.
(2) Funding for grants
(A) For the purpose of grants under paragraph (1), there is authorized to be appropriated $1,250,000 for each fiscal year.
(B) For the purpose of grants under paragraph (1), the Secretary may for each fiscal
year make available not less than $500,000, and
not more than $1,250,000 from the amounts appropriated for the fiscal year for the programs
of the Department of Health and Human Services. Such amounts may be made available
without regard to whether amounts have been
appropriated under subparagraph (A).
(3) Certain restriction
If the Foundation receives Federal funds for
the purpose of serving as a fiscal intermediary
between Federal agencies, the Foundation
may not receive such funds for the indirect
costs of carrying out such purpose in an
amount exceeding 10 percent of the direct
costs of carrying out such purpose. The preceding sentence may not be construed as authorizing the expenditure of any grant under
paragraph (1) for such purpose.
(4) Support services
The Director of the Centers for Disease Control and Prevention may provide facilities,
utilities, and support services to the Foundation if it is determined by the Director to be
advantageous to the programs of such Centers.

§ 280e–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(j) Committee for establishment of Foundation
(1) In general
There shall be established in accordance
with this subsection a committee to carry out
the functions described in paragraph (2) (which
committee is referred to in this subsection as
the ‘‘Committee’’).
(2) Functions
The functions referred to in paragraph (1) for
the Committee are as follows:
(A) To carry out such activities as may be
necessary to incorporate the Foundation
under the laws of the State involved, including serving as incorporators for the Foundation. Such activities shall include ensuring
that the articles of incorporation for the
Foundation require that the Foundation be
established and operated in accordance with
the applicable provisions of this part (or any
successor to this part), including such provisions as may be in effect pursuant to amendments enacted after October 27, 1992.
(B) To ensure that the Foundation qualifies for and maintains the status described
in subsection (e)(3) of this section (regarding
taxation).
(C) To establish the general policies and
initial bylaws of the Foundation, which bylaws shall include the bylaws described in
subsections (e)(3) and (f)(1) of this section.
(D) To provide for the initial operation of
the Foundation, including providing for
quarters, equipment, and staff.
(E) To appoint the initial members of the
Board in accordance with the requirements
established in subsection (f)(2)(A) of this section for the composition of the Board, and in
accordance with such other qualifications as
the Committee may determine to be appropriate regarding such composition. Of the
members so appointed—
(i) 2 shall be appointed to serve for a
term of 3 years;
(ii) 2 shall be appointed to serve for a
term of 4 years; and
(iii) 3 shall be appointed to serve for a
term of 5 years.
(3) Completion of functions of Committee; initial meeting of Board
(A) The Committee shall complete the functions required in paragraph (1) not later than
September 30, 1994. The Committee shall terminate upon the expiration of the 30-day period beginning on the date on which the Secretary determines that the functions have
been completed.
(B) The initial meeting of the Board shall be
held not later than November 1, 1994.
(4) Composition
The Committee shall be composed of 5 members, each of whom shall be a voting member.
Of the members of the Committee—
(A) no fewer than 2 shall have broad, general experience in public health; and
(B) no fewer than 2 shall have broad, general experience in nonprofit private organizations (without regard to whether the individuals have experience in public health).

Page 442

(5) Chair
The Committee shall, from among the members of the Committee, designate an individual
to serve as the chair of the Committee.
(6) Terms; vacancies
The term of members of the Committee shall
be for the duration of the Committee. A vacancy in the membership of the Committee
shall not affect the power of the Committee to
carry out the duties of the Committee. If a
member of the Committee does not serve the
full term, the individual appointed to fill the
resulting vacancy shall be appointed for the
remainder of the term of the predecessor of
the individual.
(7) Compensation
Members of the Committee may not receive
compensation for service on the Committee.
Members of the Committee may be reimbursed
for travel, subsistence, and other necessary expenses incurred in carrying out the duties of
the Committee.
(8) Committee support
The Director of the Centers for Disease Control and Prevention may, from amounts available to the Director for the general administration of such Centers, provide staff and financial support to assist the Committee with
carrying out the functions described in paragraph (2). In providing such staff and support,
the Director may both detail employees and
contract for assistance.
(9) Grant for establishment of Committee
(A) With respect to a grant under paragraph
(1)(A)(i) of subsection (i) of this section for fiscal year 1993, an entity described in this paragraph is a private nonprofit entity with significant experience in domestic and international issues of public health. Not later than
180 days after October 27, 1992, the Secretary
shall make the grant to such an entity (subject to the availability of funds under paragraph (2) of such subsection).
(B) The grant referred to in subparagraph
(A) may be made to an entity only if the entity agrees that—
(i) the entity will establish a committee
that is composed in accordance with paragraph (4); and
(ii) the entity will not select an individual
for membership on the Committee unless the
individual agrees that the Committee will
operate in accordance with each of the provisions of this subsection that relate to the
operation of the Committee.
(C) The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes an agreement that
the grant will not be expended for any purpose
other than carrying out subparagraph (B).
Such a grant may be made only if an application for the grant is submitted to the Secretary containing such agreement, and the application is in such form, is made in such manner, and contains such other agreements and
such assurances and information as the Secretary determines to be necessary to carry out
this paragraph.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title III, § 399G, formerly
§ 399F, as added Pub. L. 102–531, title II, § 201,
Oct. 27, 1992, 106 Stat. 3474; renumbered § 399G,
Pub. L. 106–310, div. A, title V, § 502(3), Oct. 17,
2000, 114 Stat. 1115; amended Pub. L. 109–245, § 1,
July 26, 2006, 120 Stat. 575.)
REFERENCES IN TEXT
The Ethics in Government Act, referred to in subsec.
(h)(4)(A), probably means the Ethics in Government
Act of 1978, Pub. L. 95–521, Oct. 26, 1978, 92 Stat. 1824, as
amended. For complete classification of this Act to the
Code, see Short Title note set out under section 101 of
Pub. L. 95–521 in the Appendix to Title 5, Government
Organization and Employees, and Tables.
The Technology Transfer Act, referred to in subsec.
(h)(4)(A), may mean the Federal Technology Transfer
Act of 1986, Pub. L. 99–502, Oct. 20, 1986, 100 Stat. 1785,
as amended, or the National Competitiveness Technology Transfer Act of 1989, part C (§§ 3131–3133) of title
XXXI of div. C of Pub. L. 101–189, Nov. 29, 1989, 103 Stat.
1674. For complete classification of these Acts to the
Code, see Short Title of 1986 Amendment note and
Short Title of 1989 Amendment note both set out under
section 3701 of Title 15, Commerce and Trade, and
Tables.
CODIFICATION
Section was formerly classified to section 280d–11 of
this title prior to renumbering by Pub. L. 106–310.
PRIOR PROVISIONS
A prior section 399G of act July 1, 1944, was renumbered section 399H and was classified to section 280f of
this title, prior to being omitted from the Code.

Section 280f, act July 1, 1944, ch. 373, title III, § 399H,
formerly § 399G, as added Pub. L. 105–392, title IV,
§ 419(d), Nov. 13, 1998, 112 Stat. 3593; renumbered § 399H
and amended Pub. L. 106–310, div. A, title V, § 502(4)(A),
(B), Oct. 17, 2000, 114 Stat. 1115, required the Secretary
of Health and Human Services to establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention, intervention and services delivery program and to establish the National Task Force on
Fetal Alcohol Syndrome and Fetal Alcohol Effect.
Section 280f–1, act July 1, 1944, ch. 373, title III, § 399I,
formerly § 399H, as added Pub. L. 105–392, title IV,
§ 419(d), Nov. 13, 1998, 112 Stat. 3594; renumbered § 399I,
Pub. L. 106–310, div. A, title V, § 502(4)(A), Oct. 17, 2000,
114 Stat. 1115, provided eligibility criteria for receiving
a grant or entering into a cooperative agreement or
contract under this part.
Section 280f–2, act July 1, 1944, ch. 373, title III, § 399J,
formerly § 399I, as added Pub. L. 105–392, title IV,
§ 419(d), Nov. 13, 1998, 112 Stat. 3595; renumbered § 399J
and amended Pub. L. 106–310, div. A, title V, § 502(4)(A),
(C), Oct. 17, 2000, 114 Stat. 1115, authorized appropriations to carry out this part.
Section 280f–3, act July 1, 1944, ch. 373, title III, § 399K,
formerly § 399J, as added Pub. L. 105–392, title IV,
§ 419(d), Nov. 13, 1998, 112 Stat. 3595; renumbered § 399K
and amended Pub. L. 106–310, div. A, title V, § 502(4)(A),
(D), Oct. 17, 2000, 114 Stat. 1115, provided for the expiration of this part 7 years after the date on which all
members of the National Task Force had been appointed.
CONGRESSIONAL FINDINGS AND PURPOSE
Pub. L. 105–392, title IV, § 419(b), (c), Nov. 13, 1998, 112
Stat. 3591, 3592, as amended by Pub. L. 111–256, § 2(g),
Oct. 5, 2010, 124 Stat. 2644, provided findings and purpose
related to prevention of Fetal Alcohol Syndrome and
Fetal Alcohol Effect.

AMENDMENTS
2006—Subsec. (h)(2)(A). Pub. L. 109–245, § 1(a), substituted ‘‘In the case of an individual, such Director
may accept the services provided under the preceding
sentence by the individual until such time as the private funding for such individual ends.’’ for ‘‘In the case
of an individual, such Director may accept the services
provided under the preceding sentence by the individual for not more than 2 years.’’
Subsec. (h)(7)(A). Pub. L. 109–245, § 1(b)(1), inserted
‘‘, including an accounting of the use of amounts provided for under subsection (i)’’ before period at end of
second sentence.
Subsec. (h)(7)(C). Pub. L. 109–245, § 1(b)(2), added subpar. (C) and struck out former subpar. (C) which read as
follows: ‘‘The Foundation shall make copies of each report submitted under subparagraph (A) available for
public inspection, and shall upon request provide a
copy of the report to any individual for a charge not exceeding the cost of providing the copy.’’
Subsec. (i)(2)(A). Pub. L. 109–245, § 1(c)(1)(A), substituted ‘‘$1,250,000’’ for ‘‘$500,000’’.
Subsec. (i)(2)(B). Pub. L. 109–245, § 1(c)(1)(B), substituted ‘‘not less than $500,000, and not more than
$1,250,000’’ for ‘‘not more than $500,000’’.
Subsec. (i)(4). Pub. L. 109–245, § 1(c)(2), added par. (4).

PART O—FETAL ALCOHOL SYNDROME
PREVENTION AND SERVICES PROGRAM
§§ 280f to 280f–3. Omitted
CODIFICATION
Sections 280f to 280f–3, which provided for the establishment of a Fetal Alcohol Syndrome prevention and
services program, were omitted pursuant to section
280f–3 which provided that this part would no longer
apply on the date that was 7 years after the date on
which all members of the National Task Force on Fetal
Alcohol Syndrome and Fetal Alcohol Effect established
under section 280f(d)(1) were appointed, which occurred
May 17, 2000.

§ 280g

PART P—ADDITIONAL PROGRAMS
§ 280g. Children’s asthma treatment grants program
(a) Authority to make grants
(1) In general
In addition to any other payments made
under this chapter or title V of the Social Security Act [42 U.S.C. 701 et seq.], the Secretary
shall award grants to eligible entities to carry
out the following purposes:
(A) To provide access to quality medical
care for children who live in areas that have
a high prevalence of asthma and who lack
access to medical care.
(B) To provide on-site education to parents, children, health care providers, and
medical teams to recognize the signs and
symptoms of asthma, and to train them in
the use of medications to treat asthma and
prevent its exacerbations.
(C) To decrease preventable trips to the
emergency room by making medication
available to individuals who have not previously had access to treatment or education in the management of asthma.
(D) To provide other services, such as
smoking cessation programs, home modification, and other direct and support services that ameliorate conditions that exacerbate or induce asthma.
(2) 1 Certain projects
In making grants under paragraph (1), the
Secretary may make grants designed to develop and expand the following projects:
1 So

in original. Two pars. (2) have been enacted.

§ 280g

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) Projects to provide comprehensive
asthma services to children in accordance
with the guidelines of the National Asthma
Education and Prevention Program (through
the National Heart, Lung and Blood Institute), including access to care and treatment for asthma in a community-based setting.
(B) Projects to fully equip mobile health
care clinics that provide preventive asthma
care including diagnosis, physical examinations, pharmacological therapy, skin testing, peak flow meter testing, and other asthma-related health care services.
(C) Projects to conduct validated asthma
management education programs for patients with asthma and their families, including patient education regarding asthma
management, family education on asthma
management, and the distribution of materials, including displays and videos, to reinforce concepts presented by medical teams.
(2) 1 Award of grants
(A) Application
(i) In general
An eligible entity shall submit an application to the Secretary for a grant under
this section in such form and manner as
the Secretary may require.
(ii) Required information
An application submitted under this subparagraph shall include a plan for the use
of funds awarded under the grant and such
other information as the Secretary may
require.
(B) Requirement
In awarding grants under this section, the
Secretary shall give preference to eligible
entities that demonstrate that the activities
to be carried out under this section shall be
in localities within areas of known or suspected high prevalence of childhood asthma
or high asthma-related mortality or high
rate of hospitalization or emergency room
visits for asthma (relative to the average
asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate a high prevalence of childhood asthma or high asthmarelated mortality may include data from
Federal, State, or local vital statistics,
claims data under title XIX or XXI of the
Social Security Act [42 U.S.C. 1396 et seq.,
1397aa et seq.], other public health statistics
or surveys, or other data that the Secretary,
in consultation with the Director of the Centers for Disease Control and Prevention,
deems appropriate.
(3) Definition of eligible entity
For purposes of this section, the term ‘‘eligible entity’’ means a public or nonprofit private entity (including a State or political subdivision of a State), or a consortium of any of
such entities.
(b) Coordination with other children’s programs
An eligible entity shall identify in the plan
submitted as part of an application for a grant

Page 444

under this section how the entity will coordinate operations and activities under the grant
with—
(1) other programs operated in the State
that serve children with asthma, including
any such programs operated under title V,
XIX, or XXI of the Social Security Act [42
U.S.C. 701 et seq., 1396 et seq., 1397aa et seq.];
and
(2) one or more of the following—
(A) the child welfare and foster care and
adoption assistance programs under parts B
and E of title IV of such Act [42 U.S.C. 620 et
seq., 670 et seq.];
(B) the head start program established
under the Head Start Act (42 U.S.C. 9831 et
seq.);
(C) the program of assistance under the
special supplemental nutrition program for
women, infants and children (WIC) under
section 1786 of this title;
(D) local public and private elementary or
secondary schools; or
(E) public housing agencies, as defined in
section 1437a of this title.
(c) Evaluation
An eligible entity that receives a grant under
this section shall submit to the Secretary an
evaluation of the operations and activities carried out under the grant that includes—
(1) a description of the health status outcomes of children assisted under the grant;
(2) an assessment of the utilization of asthma-related health care services as a result of
activities carried out under the grant;
(3) the collection, analysis, and reporting of
asthma data according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention; and
(4) such other information as the Secretary
may require.
(d) Preference for States that allow students to
self-administer medication to treat asthma
and anaphylaxis
(1) Preference
The Secretary, in making any grant under
this section or any other grant that is asthmarelated (as determined by the Secretary) to a
State, shall give preference to any State that
satisfies the following:
(A) In general
The State must require that each public
elementary school and secondary school in
that State will grant to any student in the
school an authorization for the self-administration of medication to treat that student’s
asthma or anaphylaxis, if—
(i) a health care practitioner prescribed
the medication for use by the student during school hours and instructed the student in the correct and responsible use of
the medication;
(ii) the student has demonstrated to the
health care practitioner (or such practitioner’s designee) and the school nurse (if
available) the skill level necessary to use
the medication and any device that is necessary to administer such medication as
prescribed;

Page 445

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iii) the health care practitioner formulates a written treatment plan for managing asthma or anaphylaxis episodes of the
student and for medication use by the student during school hours; and
(iv) the student’s parent or guardian has
completed and submitted to the school any
written documentation required by the
school, including the treatment plan formulated under clause (iii) and other documents related to liability.
(B) Scope
An authorization granted under subparagraph (A) must allow the student involved to
possess and use his or her medication—
(i) while in school;
(ii) while at a school-sponsored activity,
such as a sporting event; and
(iii) in transit to or from school or
school-sponsored activities.
(C) Duration of authorization
An authorization granted under subparagraph (A)—
(i) must be effective only for the same
school and school year for which it is
granted; and
(ii) must be renewed by the parent or
guardian each subsequent school year in
accordance with this subsection.
(D) Backup medication
The State must require that backup medication, if provided by a student’s parent or
guardian, be kept at a student’s school in a
location to which the student has immediate
access in the event of an asthma or anaphylaxis emergency.
(E) Maintenance of information
The State must require that information
described in subparagraphs (A)(iii) and
(A)(iv) be kept on file at the student’s school
in a location easily accessible in the event of
an asthma or anaphylaxis emergency.
(2) Rule of construction
Nothing in this subsection creates a cause of
action or in any other way increases or diminishes the liability of any person under any
other law.
(3) Definitions
For purposes of this subsection:
(A) The terms ‘‘elementary school’’ and
‘‘secondary school’’ have the meaning given
to those terms in section 7801 of title 20.
(B) The term ‘‘health care practitioner’’
means a person authorized under law to prescribe drugs subject to section 353(b) of title
21.
(C) The term ‘‘medication’’ means a drug
as that term is defined in section 321 of title
21 and includes inhaled bronchodilators and
auto-injectable epinephrine.
(D) The term ‘‘self-administration’’ means
a student’s discretionary use of his or her
prescribed asthma or anaphylaxis medication, pursuant to a prescription or written
direction from a health care practitioner.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such

§ 280g

sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 399L, as added
Pub. L. 106–310, div. A, title V, § 501, Oct. 17, 2000,
114 Stat. 1113; amended Pub. L. 108–377, § 3(a),
Oct. 30, 2004, 118 Stat. 2203.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (a)(1),
(2)(B) and (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531, 49
Stat. 620, as amended. Parts B and E of title IV of the
Act are classified generally to parts B (§ 620 et seq.) and
E (§ 670 et seq.), respectively, of subchapter IV of chapter 7 of this title. Titles V, XIX, and XXI of the Act are
classified generally to subchapters V (§ 701 et seq.), XIX
(§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively,
of chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
The Head Start Act, referred to in subsec. (b)(2)(B), is
subchapter B (§§ 635–657) of chapter 8 of subtitle A of
title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, as
amended, which is classified generally to subchapter II
(§ 9831 et seq.) of chapter 105 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 9801 of this title and Tables.
PRIOR PROVISIONS
A prior section 399L of act July 1, 1944, was renumbered section 399F and is classified to section 280e–4 of
this title.
AMENDMENTS
2004—Subsecs. (d), (e). Pub. L. 108–377 added subsec.
(d) and redesignated former subsec. (d) as (e).
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108–377, § 3(b), Oct. 30, 2004, 118 Stat. 2204, provided that: ‘‘The amendments made by this section
[amending this section] shall apply only with respect to
grants made on or after the date that is 9 months after
the date of the enactment of this Act [Oct. 30, 2004].’’
FINDINGS OF 2004 AMENDMENT
Pub. L. 108–377, § 2, Oct. 30, 2004, 118 Stat. 2202, provided that: ‘‘The Congress finds the following:
‘‘(1) Asthma is a chronic condition requiring lifetime, ongoing medical intervention.
‘‘(2) In 1980, 6,700,000 Americans had asthma.
‘‘(3) In 2001, 20,300,000 Americans had asthma;
6,300,000 children under age 18 had asthma.
‘‘(4) The prevalence of asthma among AfricanAmerican children was 40 percent greater than among
Caucasian children, and more than 26 percent of all
asthma deaths are in the African-American population.
‘‘(5) In 2000, there were 1,800,000 asthma-related visits to emergency departments (more than 728,000 of
these involved children under 18 years of age).
‘‘(6) In 2000, there were 465,000 asthma-related hospitalizations (214,000 of these involved children under
18 years of age).
‘‘(7) In 2000, 4,487 people died from asthma, and of
these 223 were children.
‘‘(8) According to the Centers for Disease Control
and Prevention, asthma is a common cause of missed
school days, accounting for approximately 14,000,000
missed school days annually.
‘‘(9) According to the New England Journal of Medicine, working parents of children with asthma lose an
estimated $1,000,000,000 a year in productivity.
‘‘(10) At least 30 States have legislation protecting
the rights of children to carry and self-administer
asthma metered-dose inhalers, and at least 18 States
expand this protection to epinephrine auto-injectors.
‘‘(11) Tragic refusals of schools to permit students
to carry their inhalers and auto-injectable epineph-

§ 280g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

rine have occurred, some resulting in death and
spawning litigation.
‘‘(12) School district medication policies must be
developed with the safety of all students in mind. The
immediate and correct use of asthma inhalers and
auto-injectable epinephrine are necessary to avoid serious respiratory complications and improve health
care outcomes.
‘‘(13) No school should interfere with the patientphysician relationship.
‘‘(14) Anaphylaxis, or anaphylactic shock, is a systemic allergic reaction that can kill within minutes.
Anaphylaxis occurs in some asthma patients. According to the American Academy of Allergy, Asthma,
and Immunology, people who have experienced symptoms of anaphylaxis previously are at risk for subsequent reactions and should carry an epinephrine
auto-injector with them at all times, if prescribed.
‘‘(15) An increasing number of students and school
staff have life-threatening allergies. Exposure to the
affecting allergen can trigger anaphylaxis. Anaphylaxis requires prompt medical intervention with an
injection of epinephrine.’’

§ 280g–1. Early detection, diagnosis, and treatment regarding hearing loss in newborns
and infants
(a)

Statewide newborn and infant hearing
screening, evaluation and intervention programs and systems
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing screening, evaluation,
diagnosis, and intervention programs and systems, and to assist in the recruitment, retention, education, and training of qualified personnel and health care providers, for the following
purposes:
(1) To develop and monitor the efficacy of
statewide programs and systems for hearing
screening of newborns and infants; prompt
evaluation and diagnosis of children referred
from screening programs; and appropriate educational, audiological, and medical interventions for children identified with hearing loss.
Early intervention includes referral to and delivery of information and services by schools
and agencies, including community, consumer,
and parent-based agencies and organizations
and other programs mandated by part C of the
Individuals with Disabilities Education Act [20
U.S.C. 1431 et seq.], which offer programs specifically designed to meet the unique language
and communication needs of deaf and hard of
hearing newborns, infants, toddlers, and children. Programs and systems under this paragraph shall establish and foster family-to-family support mechanisms that are critical in
the first months after a child is identified with
hearing loss.
(2) To collect data on statewide newborn and
infant hearing screening, evaluation and intervention programs and systems that can be
used for applied research, program evaluation
and policy development.
(3) Other activities may include developing
efficient models to ensure that newborns and
infants who are identified with a hearing loss
through screening receive follow-up by a
qualified health care provider, and State agencies shall be encouraged to adopt models that

Page 446

effectively increase the rate of occurrence of
such follow-up.
(b) Technical assistance, data management, and
applied research
(1) Centers for Disease Control and Prevention
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramural program and to conduct applied research related to newborn and infant hearing
screening, evaluation and intervention programs and systems. The program shall develop
standardized procedures for data management
and program effectiveness and costs, such as—
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, diagnosis, and intervention programs
and systems;
(B) to provide technical assistance on data
collection and management;
(C) to study the costs and effectiveness of
newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in
order to answer issues of importance to
State and national policymakers;
(D) to identify the causes and risk factors
for congenital hearing loss;
(E) to study the effectiveness of newborn
and infant hearing screening, audiologic and
medical evaluations and intervention programs and systems by assessing the health,
intellectual and social developmental, cognitive, and language status of these children
at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth
defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing
loss.
(2) National Institutes of Health
The Director of the National Institutes of
Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
this section, continue a program of research
and development on the efficacy of new
screening techniques and technology, including clinical studies of screening methods,
studies on efficacy of intervention, and related
research.
(c) Coordination and collaboration
(1) In general
In carrying out programs under this section,
the Administrator of the Health Resources and
Services Administration, the Director of the
Centers for Disease Control and Prevention,
and the Director of the National Institutes of
Health shall collaborate and consult with
other Federal agencies; State and local agencies, including those responsible for early
intervention services pursuant to title XIX of
the Social Security Act [42 U.S.C. 1396 et seq.]
(Medicaid Early and Periodic Screening, Diagnosis and Treatment Program); title XXI of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Social Security Act [42 U.S.C. 1397aa et
seq.] (State Children’s Health Insurance Program); title V of the Social Security Act [42
U.S.C. 701 et seq.] (Maternal and Child Health
Block Grant Program); and part C of the Individuals with Disabilities Education Act [20
U.S.C. 1431 et seq.]; consumer groups of and
that serve individuals who are deaf and hardof-hearing and their families; appropriate national medical and other health and education
specialty organizations; persons who are deaf
and hard-of-hearing and their families; other
qualified professional personnel who are proficient in deaf or hard-of-hearing children’s
language and who possess the specialized
knowledge, skills, and attributes needed to
serve deaf and hard-of-hearing newborns, infants, toddlers, children, and their families;
third-party payers and managed care organizations; and related commercial industries.
(2) Policy development
The Administrator of the Health Resources
and Services Administration, the Director of
the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
the private sector, including consumer, medical and other health and education professional-based organizations, with respect to
newborn and infant hearing screening, evaluation, diagnosis, and intervention programs and
systems.
(3) State early detection, diagnosis, and intervention programs and systems; data collection
The Administrator of the Health Resources
and Services Administration and the Director
of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant
hearing screening, evaluation, diagnosis, and
intervention programs and systems under subsection (a) of this section and to develop a
data collection system under subsection (b) of
this section.
(d) Rule of construction; religious accommodation
Nothing in this section shall be construed to
preempt or prohibit any State law, including
State laws which do not require the screening
for hearing loss of newborn infants or young
children of parents who object to the screening
on the grounds that such screening conflicts
with the parents’ religious beliefs.
(e) Definitions
For purposes of this section:
(1) The term ‘‘audiologic evaluation’’ refers
to procedures to assess the status of the auditory system; to establish the site of the auditory disorder; the type and degree of hearing
loss, and the potential effects of hearing loss
on communication; and to identify appropriate treatment and referral options. Referral
options should include linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act [20

§ 280g–1

U.S.C. 1431 et seq.] or other appropriate agencies, medical evaluation, hearing aid/sensory
aid assessment, audiologic rehabilitation
treatment, national and local consumer, selfhelp, parent, and education organizations, and
other family-centered services.
(2) The terms ‘‘audiologic rehabilitation’’
and ‘‘audiologic intervention’’ refer to procedures, techniques, and technologies to facilitate the receptive and expressive communication abilities of a child with hearing loss.
(3) The term ‘‘early intervention’’ refers to
providing appropriate services for the child
with hearing loss, including nonmedical services, and ensuring that families of the child
are provided comprehensive, consumer-oriented information about the full range of family support, training, information services,
and language and communication options and
are given the opportunity to consider and obtain the full range of such appropriate services, educational and program placements, and
other options for their child from highly qualified providers.
(4) The term ‘‘medical evaluation by a physician’’ refers to key components including history, examination, and medical decision making focused on symptomatic and related body
systems for the purpose of diagnosing the etiology of hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.
(5) The term ‘‘medical intervention’’ refers
to the process by which a physician provides
medical diagnosis and direction for medical
and/or surgical treatment options of hearing
loss and/or related medical disorder associated
with hearing loss.
(6) The term ‘‘newborn and infant hearing
screening’’ refers to objective physiologic procedures to detect possible hearing loss and to
identify newborns and infants who require further audiologic and medical evaluations.
(f) Authorization of appropriations
(1) Statewide newborn and infant hearing
screening, evaluation and intervention programs and systems
For the purpose of carrying out subsection
(a) of this section, there are authorized to be
appropriated to the Health Resources and
Services Administration such sums as may be
necessary for fiscal years 2011 through 2015.
(2) Technical assistance, data management,
and applied research; Centers for Disease
Control and Prevention
For the purpose of carrying out subsection
(b)(1) of this section, there are authorized to
be appropriated to the Centers for Disease
Control and Prevention such sums as may be
necessary for fiscal years 2011 through 2015.
(3) Technical assistance, data management,
and applied research; national institute on
deafness and other communication disorders
For the purpose of carrying out subsection
(b)(2) of this section, there are authorized to
be appropriated to the National Institute on
Deafness and Other Communication Disorders
such sums as may be necessary for fiscal years
2011 through 2015.

§ 280g–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 448

(July 1, 1944, ch. 373, title III, § 399M, as added
Pub. L. 106–310, div. A, title VII, § 702, Oct. 17,
2000, 114 Stat. 1121; amended Pub. L. 111–337, § 2,
Dec. 22, 2010, 124 Stat. 3588.)

ice Act [42 U.S.C. 280g–1] shall be known as the ‘James
T. Walsh Universal Newborn Hearing Screening Program.’ ’’

REFERENCES IN TEXT

Pub. L. 106–310, div. A, title VII, § 701, Oct. 17, 2000, 114
Stat. 1120, provided that: ‘‘The purposes of this title
[enacting this section] are to clarify the authority
within the Public Health Service Act [this chapter] to
authorize statewide newborn and infant hearing screening, evaluation and intervention programs and systems, technical assistance, a national applied research
program, and interagency and private sector collaboration for policy development, in order to assist the
States in making progress toward the following goals:
‘‘(1) All babies born in hospitals in the United
States and its territories should have a hearing
screening before leaving the birthing facility. Babies
born in other countries and residing in the United
States via immigration or adoption should have a
hearing screening as early as possible.
‘‘(2) All babies who are not born in hospitals in the
United States and its territories should have a hearing screening within the first 3 months of life.
‘‘(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to
allow appropriate referral and provisions for
audiologic rehabilitation, medical and early intervention before the age of 6 months.
‘‘(4) All newborn and infant hearing screening programs and systems should include a component for
audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing state-wide systems of intervention and rehabilitative services for newborns and infants with
hearing loss.
‘‘(5) Public policy in regard to newborn and infant
hearing screening and intervention should be based
on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or
hard-of-hearing have unique language, learning, and
communication needs, and should be the result of
consultation with pertinent public and private sectors.’’

The Individuals with Disabilities Education Act, referred to in subsecs. (a)(1), (c)(1), and (e)(1), is title VI
of Pub. L. 91–230, Apr. 13, 1970, 84 Stat. 175. Part C of the
Act is classified generally to subchapter III (§ 1431 et
seq.) of chapter 33 of Title 20, Education. For complete
classification of this Act to the Code, see section 1400
of Title 20 and Tables.
The Social Security Act, referred to in subsec. (c)(1),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles V, XIX,
and XXI of the Act are classified generally to subchapters V (§ 701 et seq.), XIX (§ 1396 et seq.), and XXI
(§ 1397aa et seq.), respectively, of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
AMENDMENTS
2010—Pub. L. 111–337, § 2(1), substituted ‘‘newborns
and infants’’ for ‘‘infants’’ in section catchline.
Subsec. (a). Pub. L. 111–337, § 2(2)(A), substituted
‘‘screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the recruitment,
retention, education, and training of qualified personnel and health care providers,’’ for ‘‘screening, evaluation and intervention programs and systems’’ in introductory provisions.
Subsec. (a)(1). Pub. L. 111–337, § 2(2)(B), amended par.
(1) generally. Prior to amendment, par. (1) read as follows: ‘‘To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation
and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated
by part C of the Individuals with Disabilities Education
Act, which offer programs specifically designed to meet
the unique language and communication needs of deaf
and hard of hearing newborns, infants, toddlers, and
children.’’
Subsec. (a)(3). Pub. L. 111–337, § 2(2)(C), added par. (3).
Subsec. (b)(1)(A). Pub. L. 111–337, § 2(3), substituted
‘‘hearing loss screening, evaluation, diagnosis, and
intervention programs’’ for ‘‘hearing loss screening,
evaluation, and intervention programs’’.
Subsec. (c)(2), (3). Pub. L. 111–337, § 2(4), substituted
‘‘hearing screening, evaluation, diagnosis, and intervention programs’’ for ‘‘hearing screening, evaluation
and intervention programs’’.
Subsec. (e)(3). Pub. L. 111–337, § 2(5)(A), substituted
‘‘ensuring that families of the child are provided comprehensive, consumer-oriented information about the
full range of family support, training, information
services, and language and communication options and
are given the opportunity to consider and obtain the
full range of such appropriate services, educational and
program placements, and other options for their child
from highly qualified providers.’’ for ‘‘ensuring that
families of the child are provided comprehensive, consumer-oriented information about the full range of
family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.’’
Subsec. (e)(6). Pub. L. 111–337, § 2(5)(B), struck out
‘‘, after rescreening,’’ after ‘‘infants who’’.
Subsec. (f). Pub. L. 111–337, § 2(6), substituted ‘‘fiscal
years 2011 through 2015’’ for ‘‘fiscal year 2002’’ in pars.
(1) to (3).
JAMES T. WALSH UNIVERSAL NEWBORN HEARING
SCREENING PROGRAM
Pub. L. 111–8, div. F, title II, § 224, Mar. 11, 2009, 123
Stat. 784, provided that: ‘‘Hereafter, the activities authorized under section 399M of the Public Health Serv-

PURPOSES

§ 280g–2. Childhood malignancies
(a) In general
The Secretary, acting as appropriate through
the Director of the Centers for Disease Control
and Prevention and the Director of the National
Institutes of Health, shall study environmental
and other risk factors for childhood cancers (including skeletal malignancies, leukemias, malignant tumors of the central nervous system,
lymphomas, soft tissue sarcomas, and other malignant neoplasms) and carry out projects to improve outcomes among children with childhood
cancers and resultant secondary conditions, including limb loss, anemia, rehabilitation, and
palliative care. Such projects shall be carried
out by the Secretary directly and through
awards of grants or contracts.
(b) Certain activities
Activities under subsection (a) of this section
include—
(1) the expansion of current demographic
data collection and population surveillance efforts to include childhood cancers nationally;
(2) the development of a uniform reporting
system under which treating physicians, hospitals, clinics, and States report the diagnosis
of childhood cancers, including relevant associated epidemiological data; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) support for the National Limb Loss Information Center to address, in part, the primary
and secondary needs of persons who experience
childhood cancers in order to prevent or minimize the disabling nature of these cancers.
(c) Coordination of activities
The Secretary shall assure that activities
under this section are coordinated as appropriate with other agencies of the Public Health
Service that carry out activities focused on
childhood cancers and limb loss.
(d) Definition
For purposes of this section, the term ‘‘childhood cancer’’ refers to a spectrum of different
malignancies that vary by histology, site of disease, origin, race, sex, and age. The Secretary
may for purposes of this section revise the definition of such term to the extent determined by
the Secretary to be appropriate.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title III, § 399N, as added
Pub. L. 106–310, div. A, title XI, § 1101, Oct. 17,
2000, 114 Stat. 1131.)
§ 280g–3. Controlled substance monitoring program
(a) Grants
(1) In general
Each fiscal year, the Secretary shall award a
grant to each State with an application approved under this section to enable the State—
(A) to establish and implement a State
controlled substance monitoring program; or
(B) to make improvements to an existing
State controlled substance monitoring program.
(2) Determination of amount
(A) Minimum amount
In making payments under a grant under
paragraph (1) for a fiscal year, the Secretary
shall allocate to each State with an application approved under this section an amount
that equals 1.0 percent of the amount appropriated to carry out this section for that fiscal year.
(B) Additional amounts
In making payments under a grant under
paragraph (1) for a fiscal year, the Secretary
shall allocate to each State with an application approved under this section an additional amount which bears the same ratio to
the amount appropriated to carry out this
section for that fiscal year and remaining
after amounts are made available under subparagraph (A) as the number of pharmacies
of the State bears to the number of pharmacies of all States with applications approved under this section (as determined by
the Secretary), except that the Secretary
may adjust the amount allocated to a State
under this subparagraph after taking into
consideration the budget cost estimate for

§ 280g–3

the State’s controlled substance monitoring
program.
(3) Term of grants
Grants awarded under this section shall be
obligated in the year in which funds are allotted.
(b) Development of minimum requirements
Prior to awarding a grant under this section,
and not later than 6 months after the date on
which funds are first appropriated to carry out
this section, after seeking consultation with
States and other interested parties, the Secretary shall, after publishing in the Federal
Register proposed minimum requirements and
receiving public comments, establish minimum
requirements for criteria to be used by States
for purposes of clauses (ii), (v), (vi), and (vii) of
subsection (c)(1)(A) of this section.
(c) Application approval process
(1) In general
To be eligible to receive a grant under this
section, a State shall submit an application to
the Secretary at such time, in such manner,
and containing such assurances and information as the Secretary may reasonably require.
Each such application shall include—
(A) with respect to a State that intends to
use funds under the grant as provided for in
subsection (a)(1)(A) of this section—
(i) a budget cost estimate for the controlled substance monitoring program to
be implemented under the grant;
(ii) criteria for security for information
handling and for the database maintained
by the State under subsection (e) of this
section generally including efforts to use
appropriate encryption technology or
other appropriate technology to protect
the security of such information;
(iii) an agreement to adopt health information interoperability standards, including health vocabulary and messaging
standards, that are consistent with any
such standards generated or identified by
the Secretary or his or her designee;
(iv) criteria for meeting the uniform
electronic format requirement of subsection (h) of this section;
(v) criteria for availability of information and limitation on access to program
personnel;
(vi) criteria for access to the database,
and procedures to ensure that information
in the database is accurate;
(vii) criteria for the use and disclosure of
information, including a description of the
certification process to be applied to requests for information under subsection (f)
of this section;
(viii) penalties for the unauthorized use
and disclosure of information maintained
in the State controlled substance monitoring program in violation of applicable
State law or regulation;
(ix) information on the relevant State
laws, policies, and procedures, if any, regarding purging of information from the
database; and
(x) assurances of compliance with all
other requirements of this section; or

§ 280g–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) with respect to a State that intends to
use funds under the grant as provided for in
subsection (a)(1)(B) of this section—
(i) a budget cost estimate for the controlled substance monitoring program to
be improved under the grant;
(ii) a plan for ensuring that the State
controlled substance monitoring program
is in compliance with the criteria and penalty requirements described in clauses (ii)
through (viii) of subparagraph (A);
(iii) a plan to enable the State controlled
substance monitoring program to achieve
interoperability with at least one other
State controlled substance monitoring
program; and
(iv) assurances of compliance with all
other requirements of this section or a
statement describing why such compliance
is not feasible or is contrary to the best interests of public health in such State.
(2) State legislation
As part of an application under paragraph
(1), the Secretary shall require a State to demonstrate that the State has enacted legislation or regulations to permit the implementation of the State controlled substance monitoring program and the imposition of appropriate penalties for the unauthorized use and
disclosure of information maintained in such
program.
(3) Interoperability
If a State that submits an application under
this subsection geographically borders another
State that is operating a controlled substance
monitoring program under subsection (a)(1) of
this section on the date of submission of such
application, and such applicant State has not
achieved interoperability for purposes of information sharing between its monitoring program and the monitoring program of such border State, such applicant State shall, as part
of the plan under paragraph (1)(B)(iii), describe
the manner in which the applicant State will
achieve interoperability between the monitoring programs of such States.
(4) Approval
If a State submits an application in accordance with this subsection, the Secretary shall
approve such application.
(5) Return of funds
If the Secretary withdraws approval of a
State’s application under this section, or the
State chooses to cease to implement or improve a controlled substance monitoring program under this section, a funding agreement
for the receipt of a grant under this section is
that the State will return to the Secretary an
amount which bears the same ratio to the
overall grant as the remaining time period for
expending the grant funds bears to the overall
time period for expending the grant (as specified by the Secretary at the time of the grant).
(d) Reporting requirements
In implementing or improving a controlled
substance monitoring program under this section, a State shall comply, or with respect to a
State that applies for a grant under subsection

Page 450

(a)(1)(B) of this section submit to the Secretary
for approval a statement of why such compliance is not feasible or is contrary to the best interests of public health in such State, with the
following:
(1) The State shall require dispensers to report to such State each dispensing in the
State of a controlled substance to an ultimate
user not later than 1 week after the date of
such dispensing.
(2) The State may exclude from the reporting requirement of this subsection—
(A) the direct administration of a controlled substance to the body of an ultimate
user;
(B) the dispensing of a controlled substance in a quantity limited to an amount
adequate to treat the ultimate user involved
for 48 hours or less; or
(C) the administration or dispensing of a
controlled substance in accordance with any
other exclusion identified by the Secretary
for purposes of this paragraph.
(3) The information to be reported under this
subsection with respect to the dispensing of a
controlled substance shall include the following:
(A) Drug Enforcement Administration
Registration Number (or other identifying
number used in lieu of such Registration
Number) of the dispenser.
(B) Drug Enforcement Administration
Registration Number (or other identifying
number used in lieu of such Registration
Number) and name of the practitioner who
prescribed the drug.
(C) Name, address, and telephone number
of the ultimate user or such contact information of the ultimate user as the Secretary
determines appropriate.
(D) Identification of the drug by a national
drug code number.
(E) Quantity dispensed.
(F) Number of refills ordered.
(G) Whether the drug was dispensed as a
refill of a prescription or as a first-time request.
(H) Date of the dispensing.
(I) Date of origin of the prescription.
(J) Such other information as may be required by State law to be reported under this
subsection.
(4) The State shall require dispensers to report information under this section in accordance with the electronic format specified by
the Secretary under subsection (h) of this section, except that the State may waive the requirement of such format with respect to an
individual dispenser that is unable to submit
such information by electronic means.
(e) Database
In implementing or improving a controlled
substance monitoring program under this section, a State shall comply with the following:
(1) The State shall establish and maintain
an electronic database containing the information reported to the State under subsection
(d) of this section.
(2) The database must be searchable by any
field or combination of fields.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) The State shall include reported information in the database in a manner consistent
with criteria established by the Secretary,
with appropriate safeguards for ensuring the
accuracy and completeness of the database.
(4) The State shall take appropriate security
measures to protect the integrity of, and access to, the database.
(f) Use and disclosure of information
(1) In general
Subject to subsection (g) of this section, in
implementing or improving a controlled substance monitoring program under this section,
a State may disclose information from the
database established under subsection (e) of
this section and, in the case of a request under
subparagraph (D), summary statistics of such
information, only in response to a request by—
(A) a practitioner (or the agent thereof)
who certifies, under the procedures determined by the State, that the requested information is for the purpose of providing medical or pharmaceutical treatment or evaluating the need for such treatment to a bona
fide current patient;
(B) any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, who certifies, under the procedures determined by
the State, that the requested information is
related to an individual investigation or proceeding involving the unlawful diversion or
misuse of a schedule II, III, or IV substance,
and such information will further the purpose of the investigation or assist in the proceeding;
(C) the controlled substance monitoring
program of another State or group of States
with whom the State has established an
interoperability agreement;
(D) any agent of the Department of Health
and Human Services, a State medicaid program, a State health department, or the
Drug Enforcement Administration who certifies that the requested information is necessary for research to be conducted by such
department, program, or administration, respectively, and the intended purpose of the
research is related to a function committed
to such department, program, or administration by law that is not investigative in nature; or
(E) an agent of the State agency or entity
of another State that is responsible for the
establishment and maintenance of that
State’s controlled substance monitoring program, who certifies that—
(i) the State has an application approved
under this section; and
(ii) the requested information is for the
purpose of implementing the State’s controlled substance monitoring program
under this section.
(2) Drug diversion
In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving a grant under subsection (a) of this section—
(A) shall establish a program to notify
practitioners and dispensers of information

§ 280g–3

that will help identify and prevent the unlawful diversion or misuse of controlled substances; and
(B) may, to the extent permitted under
State law, notify the appropriate authorities
responsible for carrying out drug diversion
investigations if the State determines that
information in the database maintained by
the State under subsection (e) of this section
indicates an unlawful diversion or abuse of a
controlled substance.
(g) Limitations
In implementing or improving a controlled
substance monitoring program under this section, a State—
(1) shall limit the information provided pursuant to a valid request under subsection (f)(1)
of this section to the minimum necessary to
accomplish the intended purpose of the request; and
(2) shall limit information provided in response to a request under subsection (f)(1)(D)
of this section to nonidentifiable information.
(h) Electronic format
The Secretary shall specify a uniform electronic format for the reporting, sharing, and disclosure of information under this section.
(i) Rules of construction
(1) Functions otherwise authorized by law
Nothing in this section shall be construed to
restrict the ability of any authority, including
any local, State, or Federal law enforcement,
narcotics control, licensure, disciplinary, or
program authority, to perform functions
otherwise authorized by law.
(2) No preemption
Nothing in this section shall be construed as
preempting any State law, except that no such
law may relieve any person of a requirement
otherwise applicable under this chapter.
(3) Additional privacy protections
Nothing in this section shall be construed as
preempting any State from imposing any additional privacy protections.
(4) Federal privacy requirements
Nothing in this section shall be construed to
supersede any Federal privacy or confidentiality requirement, including the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act
of 1996 (Public Law 104–191; 110 Stat. 2033) and
section 290dd–2 of this title.
(5) No Federal private cause of action
Nothing in this section shall be construed to
create a Federal private cause of action.
(j) Studies and reports
(1) Implementation report
(A) In general
Not later than 180 days after August 11,
2005, the Secretary, based on a review of existing State controlled substance monitoring programs and other relevant information, shall determine whether the implementation of such programs has had a substantial negative impact on—

§ 280g–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) patient access to treatment, including
therapy for pain or controlled substance
abuse;
(ii) pediatric patient access to treatment; or
(iii) patient enrollment in research or
clinical trials in which, following the protocol that has been approved by the relevant institutional review board for the
research or clinical trial, the patient has
obtained a controlled substance from either the scientific investigator conducting
such research or clinical trial or the agent
thereof.
(B) Additional categories of exclusion
If the Secretary determines under subparagraph (A) that a substantial negative impact
has been demonstrated with regard to one or
more of the categories of patients described
in such subparagraph, the Secretary shall
identify additional appropriate categories of
exclusion from reporting as authorized
under subsection (d)(2)(C) of this section.
(2) Progress report
Not later than 3 years after the date on
which funds are first appropriated under this
section, the Secretary shall—
(A) complete a study that—
(i) determines the progress of States in
establishing and implementing controlled
substance monitoring programs under this
section;
(ii) provides an analysis of the extent to
which the operation of controlled substance monitoring programs have reduced
inappropriate use, abuse, or diversion of
controlled substances or affected patient
access to appropriate pain care in States
operating such programs;
(iii) determines the progress of States in
achieving interoperability between controlled substance monitoring programs, including an assessment of technical and
legal barriers to such activities and recommendations for addressing these barriers;
(iv) determines the feasibility of implementing a real-time electronic controlled
substance monitoring program, including
the costs associated with establishing such
a program;
(v) provides an analysis of the privacy
protections in place for the information
reported to the controlled substance monitoring program in each State receiving a
grant for the establishment or operation of
such program, and any recommendations
for additional requirements for protection
of this information;
(vi) determines the feasibility of implementing technological alternatives to centralized data storage, such as peer-to-peer
file sharing or data pointer systems, in
controlled substance monitoring programs
and the potential for such alternatives to
enhance the privacy and security of individually identifiable data; and
(vii) evaluates the penalties that States
have enacted for the unauthorized use and
disclosure of information maintained in
the controlled substance monitoring pro-

Page 452

gram, and reports on the criteria used by
the Secretary to determine whether such
penalties qualify as appropriate pursuant
to this section; and
(B) submit a report to the Congress on the
results of the study.
(k) Preference
Beginning 3 years after the date on which
funds are first appropriated to carry out this
section, the Secretary, in awarding any competitive grant that is related to drug abuse (as
determined by the Secretary) and for which only
States are eligible to apply, shall give preference to any State with an application approved under this section. The Secretary shall
have the discretion to apply such preference to
States with existing controlled substance monitoring programs that meet minimum requirements under this section or to States that put
forth a good faith effort to meet those requirements (as determined by the Secretary).
(l) Advisory council
(1) Establishment
A State may establish an advisory council to
assist in the establishment, implementation,
or improvement of a controlled substance
monitoring program under this section.
(2) Limitation
A State may not use amounts received under
a grant under this section for the operations of
an advisory council established under paragraph (1).
(3) Sense of Congress
It is the sense of the Congress that, in establishing an advisory council under this subsection, a State should consult with appropriate professional boards and other interested
parties.
(m) Definitions
For purposes of this section:
(1) The term ‘‘bona fide patient’’ means an
individual who is a patient of the practitioner
involved.
(2) The term ‘‘controlled substance’’ means a
drug that is included in schedule II, III, or IV
of section 812(c) of title 21.
(3) The term ‘‘dispense’’ means to deliver a
controlled substance to an ultimate user by,
or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser
uses the Internet or other means to effect such
delivery.
(4) The term ‘‘dispenser’’ means a physician,
pharmacist, or other person that dispenses a
controlled substance to an ultimate user.
(5) The term ‘‘interoperability’’ with respect
to a State controlled substance monitoring
program means the ability of the program to
electronically share reported information, including each of the required report components described in subsection (d) of this section, with another State if the information
concerns either the dispensing of a controlled
substance to an ultimate user who resides in
such other State, or the dispensing of a controlled substance prescribed by a practitioner
whose principal place of business is located in
such other State.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) The term ‘‘nonidentifiable information’’
means information that does not identify a
practitioner, dispenser, or an ultimate user
and with respect to which there is no reasonable basis to believe that the information can
be used to identify a practitioner, dispenser,
or an ultimate user.
(7) The term ‘‘practitioner’’ means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person
licensed, registered, or otherwise permitted,
by the United States or the jurisdiction in
which he or she practices or does research, to
distribute, dispense, conduct research with respect to, administer, or use in teaching or
chemical analysis, a controlled substance in
the course of professional practice or research.
(8) The term ‘‘State’’ means each of the 50
States and the District of Columbia.
(9) The term ‘‘ultimate user’’ means a person
who has obtained from a dispenser, and who
possesses, a controlled substance for his or her
own use, for the use of a member of his or her
household, or for the use of an animal owned
by him or her or by a member of his or her
household.
(n) Authorization of appropriations
To carry out this section, there are authorized
to be appropriated—
(1) $15,000,000 for each of fiscal years 2006 and
2007; and
(2) $10,000,000 for each of fiscal years 2008,
2009, and 2010.
(July 1, 1944, ch. 373, title III, § 399O, as added
Pub. L. 109–60, § 3, Aug. 11, 2005, 119 Stat. 1979.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (i)(4),
is section 264(c) of Pub. L. 104–191, which is set out as
a note under section 1320d–2 of this title.
PRIOR PROVISIONS
Another section 399O of act July 1, 1944, was renumbered section 399P and is classified to section 280g–4 of
this title.
PURPOSE
Pub. L. 109–60, § 2, Aug. 11, 2005, 119 Stat. 1979, provided that: ‘‘It is the purpose of this Act [enacting this
section and provisions set out as a note under section
201 of this title] to—
‘‘(1) foster the establishment of State-administered
controlled substance monitoring systems in order to
ensure that health care providers have access to the
accurate, timely prescription history information
that they may use as a tool for the early identification of patients at risk for addiction in order to initiate appropriate medical interventions and avert the
tragic personal, family, and community consequences
of untreated addiction; and
‘‘(2) establish, based on the experiences of existing
State controlled substance monitoring programs, a
set of best practices to guide the establishment of
new State programs and the improvement of existing
programs.’’

§ 280g–4. Grants to foster public health responses
to domestic violence, dating violence, sexual
assault, and stalking
(a) Authority to award grants
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Preven-

§ 280g–4

tion, shall award grants to eligible State, tribal, territorial, or local entities to strengthen
the response of State, tribal, territorial, or
local health care systems to domestic violence, dating violence, sexual assault, and
stalking.
(2) Eligible entities
To be eligible to receive a grant under this
section, an entity shall—
(A) be—
(i) a State department (or other division)
of health, a State domestic or sexual assault coalition or service-based program,
State law enforcement task force, or any
other nonprofit, nongovernmental, tribal,
territorial, or State entity with a history
of effective work in the fields of domestic
violence, dating violence, sexual assault or
stalking, and health care; or
(ii) a local, nonprofit domestic violence,
dating violence, sexual assault, or stalking
service-based program, a local department
(or other division) of health, a local health
clinic, hospital, or health system, or any
other nonprofit, tribal, or local entity with
a history of effective work in the field of
domestic or sexual violence and health;
(B) prepare and submit to the Secretary an
application at such time, in such manner,
and containing such agreements, assurances,
and information as the Secretary determines
to be necessary to carry out the purposes for
which the grant is to be made; and
(C) demonstrate that the entity is representing a team of organizations and agencies working collaboratively to strengthen
the response of the health care system involved to domestic violence, dating violence,
sexual assault, or stalking and that such
team includes domestic violence, dating violence, sexual assault or stalking and health
care organizations.
(3) Duration
A program conducted under a grant awarded
under this section shall not exceed 2 years.
(b) Use of funds
(1) In general
An entity shall use amounts received under
a grant under this section to design and implement comprehensive strategies to improve the
response of the health care system involved to
domestic or sexual violence in clinical and
public health settings, hospitals, clinics, managed care settings (including behavioral and
mental health), and other health settings.
(2) Mandatory strategies
Strategies implemented under paragraph (1)
shall include the following:
(A) The implementation, dissemination,
and evaluation of policies and procedures to
guide health care professionals and behavioral and public health staff in responding to
domestic violence, dating violence, sexual
assault, and stalking, including strategies to
ensure that health information is maintained in a manner that protects the patient’s privacy and safety and prohibits insurance discrimination.

§ 280g–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) The development of on-site access to
services to address the safety, medical, mental health, and economic needs of patients
either by increasing the capacity of existing
health care professionals and behavioral and
public health staff to address domestic violence, dating violence, sexual assault, and
stalking, by contracting with or hiring domestic or sexual assault advocates to provide the services, or to model other services
appropriate to the geographic and cultural
needs of a site.
(C) The evaluation of practice and the institutionalization of identification, intervention, and documentation including quality improvement measurements.
(D) The provision of training and followup
technical assistance to health care professionals, behavioral and public health staff,
and allied health professionals to identify,
assess, treat, and refer clients who are victims of domestic violence, dating violence,
sexual violence, or stalking.
(3) Permissive strategies
Strategies implemented under paragraph (1)
may include the following:
(A) Where appropriate, the development of
training modules and policies that address
the overlap of child abuse, domestic violence, dating violence, sexual assault, and
stalking and elder abuse as well as childhood
exposure to domestic violence.
(B) The creation, adaptation, and implementation of public education campaigns for
patients concerning domestic violence, dating violence, sexual assault, and stalking
prevention.
(C) The development, adaptation, and dissemination of domestic violence, dating violence, sexual assault, and stalking education
materials to patients and health care professionals and behavioral and public health
staff.
(D) The promotion of the inclusion of domestic violence, dating violence, sexual assault, and stalking into health professional
training schools, including medical, dental,
nursing school, social work, and mental
health curriculum.
(E) The integration of domestic violence,
dating violence, sexual assault, and stalking
into health care accreditation and professional licensing examinations, such as medical, dental, social work, and nursing boards.
(c) Allocation of funds
Funds appropriated under this section shall be
distributed equally between State and local programs.
(d) Authorization of appropriations
There is authorized to be appropriated to
award grants under this section, $5,000,000 for
each of fiscal years 2007 through 2011.
(July 1, 1944, ch. 373, title III, § 399P, formerly
§ 399O, as added Pub. L. 109–162, title V, § 504,
Jan. 5, 2006, 119 Stat. 3026; renumbered § 399P,
Pub. L. 109–450, § 4(1), Dec. 22, 2006, 120 Stat.
3342.)

Page 454

FINDINGS
Pub. L. 109–162, title V, § 501, Jan. 5, 2006, 119 Stat.
3023, provided that: ‘‘Congress makes the following
findings:
‘‘(1) The health-related costs of intimate partner
violence in the United States exceed $5,800,000,000 annually.
‘‘(2) Thirty-seven percent of all women who sought
care in hospital emergency rooms for violence-related
injuries were injured by a current or former spouse,
boyfriend, or girlfriend.
‘‘(3) In addition to injuries sustained during violent
episodes, physical and psychological abuse is linked
to a number of adverse physical and mental health effects. Women who have been abused are much more
likely to suffer from chronic pain, diabetes, depression, unintended pregnancies, substance abuse and
sexually transmitted infections, including HIV/AIDS.
‘‘(4) Health plans spend an average of $1,775 more a
year on abused women than on general enrollees.
‘‘(5) Each year about 324,000 pregnant women in the
United States are battered by the men in their lives.
This battering leads to complications of pregnancy,
including low weight gain, anemia, infections, and
first and second trimester bleeding.
‘‘(6) Pregnant and recently pregnant women are
more likely to be victims of homicide than to die of
any other pregnancy-related cause, and evidence exists that a significant proportion of all female homicide victims are killed by their intimate partners.
‘‘(7) Children who witness domestic violence are
more likely to exhibit behavioral and physical health
problems including depression, anxiety, and violence
towards peers. They are also more likely to attempt
suicide, abuse drugs and alcohol, run away from
home, engage in teenage prostitution, and commit
sexual assault crimes.
‘‘(8) Recent research suggests that women experiencing domestic violence significantly increase their
safety-promoting behaviors over the short- and longterm when health care providers screen for, identify,
and provide followup care and information to address
the violence.
‘‘(9) Currently, only about 10 percent of primary
care physicians routinely screen for intimate partner
abuse during new patient visits and 9 percent routinely screen for intimate partner abuse during periodic checkups.
‘‘(10) Recent clinical studies have proven the effectiveness of a 2-minute screening for early detection of
abuse of pregnant women. Additional longitudinal
studies have tested a 10-minute intervention that was
proven highly effective in increasing the safety of
pregnant abused women. Comparable research does
not yet exist to support the effectiveness of screening
men.
‘‘(11) Seventy to 81 percent of the patients studied
reported that they would like their healthcare providers to ask them privately about intimate partner
violence.’’
PURPOSE
Pub. L. 109–162, title V, § 502, Jan. 5, 2006, 119 Stat.
3024, provided that: ‘‘It is the purpose of this title [enacting this section, sections 294h and 13973 of this title,
and provisions set out as a note above] to improve the
health care system’s response to domestic violence,
dating violence, sexual assault, and stalking through
the training and education of health care providers, developing comprehensive public health responses to violence against women and children, increasing the number of women properly screened, identified, and treated
for lifetime exposure to violence, and expanding research on effective interventions in the health care setting.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 280g–5. Public and health care provider education and support services
(a) In general
The Secretary, directly or through the awarding of grants to public or private nonprofit entities, may conduct demonstration projects for
the purpose of improving the provision of information on prematurity to health professionals
and other health care providers and the public
and improving the treatment and outcomes for
babies born preterm.
(b) Activities
Activities to be carried out under the demonstration project under subsection (a) may include the establishment of—
(1) programs to test and evaluate various
strategies to provide information and education to health professionals, other health
care providers, and the public concerning—
(A) the signs of preterm labor, updated as
new research results become available;
(B) the screening for and the treating of
infections;
(c) 1 counseling on optimal weight and
good nutrition, including folic acid;
(D) smoking cessation education and counseling;
(E) stress management; and
(F) appropriate prenatal care;
(2) programs to improve the treatment and
outcomes for babies born premature, including
the use of evidence-based standards of care by
health care professionals for pregnant women
at risk of preterm labor or other serious complications and for infants born preterm and at
a low birthweight;
(3) programs to respond to the informational
needs of families during the stay of an infant
in a neonatal intensive care unit, during the
transition of the infant to the home, and in
the event of a newborn death; and
(4) such other programs as the Secretary determines appropriate to achieve the purpose
specified in subsection (a).
(c) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $5,000,000 for each of fiscal
years 2007 through 2011.
(July 1, 1944, ch. 373, title III, § 399Q, as added
Pub. L. 109–450, § 4(2), Dec. 22, 2006, 120 Stat.
3342.)
§ 280g–6. Chronic kidney disease initiatives
(a) In general
The Secretary shall establish pilot projects
to—
(1) increase public and medical community
awareness (particularly of those who treat patients with diabetes and hypertension) regarding chronic kidney disease, focusing on prevention;
(2) increase screening for chronic kidney disease, focusing on Medicare beneficiaries at
risk of chronic kidney disease; and
(3) enhance surveillance systems to better
assess the prevalence and incidence of chronic
kidney disease.
1 So

in original. Probably should be ‘‘(C)’’.

§ 280g–7

(b) Scope and duration
(1) Scope
The Secretary shall select at least 3 States
in which to conduct pilot projects under this
section.
(2) Duration
The pilot projects under this section shall be
conducted for a period that is not longer than
5 years and shall begin on January 1, 2009.
(c) Evaluation and report
The Comptroller General of the United States
shall conduct an evaluation of the pilot projects
conducted under this section. Not later than 12
months after the date on which the pilot
projects are completed, the Comptroller General
shall submit to Congress a report on the evaluation.
(d) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary for the purpose of carrying out this section.
(July 1, 1944, ch. 373, title III, § 399R, as added
Pub. L. 110–275, title I, § 152(a), July 15, 2008, 122
Stat. 2551.)
CODIFICATION
Another section 399R of act July 1, 1944, ch. 373, as
added by Pub. L. 110–373, § 2, Oct. 8, 2008, 122 Stat. 4047,
was renumbered section 399S and is classified to section
280g–7 of this title.
Another section 399R of act July 1, 1944, ch. 373, as
added by Pub. L. 110–374, § 3, Oct. 8, 2008, 122 Stat. 4051,
was renumbered section 399T and is classified to section
280g–8 of this title.

§ 280g–7. Amyotrophic lateral sclerosis registry
(a) Establishment
(1) In general
Not later than 1 year after the receipt of the
report described in subsection (b)(2)(A), the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention,
may, if scientifically advisable—
(A) develop a system to collect data on
amyotrophic lateral sclerosis (referred to in
this section as ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS,
misdiagnosed as ALS, and in some cases
progress to ALS, including information with
respect to the incidence and prevalence of
the disease in the United States; and
(B) establish a national registry for the
collection and storage of such data to develop a population-based registry of cases in
the United States of ALS and other motor
neuron disorders that can be confused with
ALS, misdiagnosed as ALS, and in some
cases progress to ALS.
(2) Purpose
It is the purpose of the registry established
under paragraph (1)(B) to—
(A) better describe the incidence and prevalence of ALS in the United States;
(B) examine appropriate factors, such as
environmental and occupational, that may
be associated with the disease;
(C) better outline key demographic factors
(such as age, race or ethnicity, gender, and

§ 280g–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

family history of individuals who are diagnosed with the disease) associated with the
disease;
(D) better examine the connection between
ALS and other motor neuron disorders that
can be confused with ALS, misdiagnosed as
ALS, and in some cases progress to ALS; and
(E) other matters as recommended by the
Advisory Committee established under subsection (b).
(b) Advisory Committee
(1) Establishment
Not later than 180 days after October 8, 2008,
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may establish a committee to be known
as the Advisory Committee on the National
ALS Registry (referred to in this section as
the ‘‘Advisory Committee’’). The Advisory
Committee shall be composed of not more
than 27 members to be appointed by the Secretary, acting through the Centers for Disease
Control and Prevention, of which—
(A) two-thirds of such members shall represent governmental agencies—
(i) including at least one member representing—
(I) the National Institutes of Health, to
include, upon the recommendation of the
Director of the National Institutes of
Health, representatives from the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences;
(II) the Department of Veterans Affairs;
(III) the Agency for Toxic Substances
and Disease Registry; and
(IV) the Centers for Disease Control
and Prevention; and
(ii) of which at least one such member
shall be a clinician with expertise on ALS
and related diseases, an epidemiologist
with experience in data registries, a statistician, an ethicist, and a privacy expert
(relating to the privacy regulations under
the Health Insurance Portability and Accountability Act of 1996); and
(B) one-third of such members shall be
public members, including at least one member representing—
(i) national and voluntary health associations; 1
(ii) patients with ALS or their family
members;
(iii) clinicians with expertise on ALS and
related diseases;
(iv) epidemiologists with experience in
data registries;
(v) geneticists or experts in genetics who
have experience with the genetics of ALS
or other neurological diseases 2 and
(vi) other individuals with an interest in
developing and maintaining the National
ALS Registry.
1 So in original. Probably should be ‘‘national voluntary health
associations;’’.
2 So in original. Probably should be followed by a semicolon.

Page 456

(2) Duties
The Advisory Committee may review information and make recommendations to the
Secretary concerning—
(A) the development and maintenance of
the National ALS Registry;
(B) the type of information to be collected
and stored in the Registry;
(C) the manner in which such data is to be
collected;
(D) the use and availability of such data
including guidelines for such use; and
(E) the collection of information about diseases and disorders that primarily affect
motor neurons that are considered essential
to furthering the study and cure of ALS.
(3) Report
Not later than 270 days after the date on
which the Advisory Committee is established,
the Advisory Committee may submit a report
to the Secretary concerning the review conducted under paragraph (2) that contains the
recommendations of the Advisory Committee
with respect to the results of such review.
(c) Grants
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may award grants to, and enter into contracts
and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on ALS and other
motor neuron disorders that can be confused
with ALS, misdiagnosed as ALS, and in some
cases progress to ALS after receiving the report
under subsection (b)(3).
(d) Coordination with State, local, and Federal
registries
(1) 3 In general
In establishing the National ALS Registry
under subsection (a), the Secretary, acting
through the Director of the Centers for Disease Control and Prevention, may—
(A) identify, build upon, expand, and coordinate among existing data and surveillance
systems, surveys, registries, and other Federal public health and environmental infrastructure wherever possible, which may include—
(i) any registry pilot projects previously
supported by the Centers for Disease Control and Prevention;
(ii) the Department of Veterans Affairs
ALS Registry;
(iii) the DNA and Cell Line Repository of
the National Institute of Neurological Disorders and Stroke Human Genetics Resource Center at the National Institutes of
Health;
(iv) Agency for Toxic Substances and
Disease Registry studies, including studies
conducted in Illinois, Missouri, El Paso
and San Antonio, Texas, and Massachusetts;
(v) State-based ALS registries;
(vi) the National Vital Statistics System; and
3 So

in original. No par. (2) has been enacted.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(vii) any other existing or relevant databases that collect or maintain information
on those motor neuron diseases recommended by the Advisory Committee established in subsection (b); and
(B) provide for research access to ALS
data as recommended by the Advisory Committee established in subsection (b) to the
extent permitted by applicable statutes and
regulations and in a manner that protects
personal privacy consistent with applicable
privacy statutes and regulations.
(C) COORDINATION WITH NIH AND DEPARTMENT OF VETERANS AFFAIRS.—Consistent
with applicable privacy statutes and regulations, the Secretary may ensure that epidemiological and other types of information
obtained under subsection (a) is made available to the National Institutes of Health and
the Department of Veterans Affairs.
(e) Definition
For the purposes of this section, the term ‘‘national voluntary health association’’ means a
national non-profit organization with chapters
or other affiliated organizations in States
throughout the United States with experience
serving the population of individuals with ALS
and have demonstrated experience in ALS research, care, and patient services.
(July 1, 1944, ch. 373, title III, § 399S, formerly
§ 399R, as added Pub. L. 110–373, § 2, Oct. 8, 2008,
122 Stat. 4047; renumbered § 399S, Pub. L. 111–148,
title IV, § 4003(b)(2)(A), Mar. 23, 2010, 124 Stat.
544.)
REFERENCES IN TEXT
The Health Insurance Portability and Accountability
Act of 1996, referred to in subsec. (b)(1)(A)(ii), is Pub. L.
104–191, Aug. 21, 1996, 110 Stat. 1936. For complete classification of this Act to the Code, see Short Title of 1996
Amendments note set out under section 201 of this title
and Tables.

§ 280g–8. Support for patients receiving a positive diagnosis of Down syndrome or other
prenatally or postnatally diagnosed conditions
(a) Definitions
In this section:
(1) Down syndrome
The term ‘‘Down syndrome’’ refers to a chromosomal disorder caused by an error in cell division that results in the presence of an extra
whole or partial copy of chromosome 21.
(2) Health care provider
The term ‘‘health care provider’’ means any
person or entity required by State or Federal
law or regulation to be licensed, registered, or
certified to provide health care services, and
who is so licensed, registered, or certified.
(3) Postnatally diagnosed condition
The term ‘‘postnatally diagnosed condition’’
means any health condition identified during
the 12-month period beginning at birth.
(4) Prenatally diagnosed condition
The term ‘‘prenatally diagnosed condition’’
means any fetal health condition identified by

§ 280g–8

prenatal genetic testing or prenatal screening
procedures.
(5) Prenatal test
The term ‘‘prenatal test’’ means diagnostic
or screening tests offered to pregnant women
seeking routine prenatal care that are administered on a required or recommended basis by
a health care provider based on medical history, family background, ethnic background,
previous test results, or other risk factors.
(b) Information and support services
(1) In general
The Secretary, acting through the Director
of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, or the Administrator of the Health
Resources and Services Administration, may
authorize and oversee certain activities, including the awarding of grants, contracts or
cooperative agreements to eligible entities,
to—
(A) collect, synthesize, and disseminate
current evidence-based information relating
to Down syndrome or other prenatally or
postnatally diagnosed conditions; and
(B) coordinate the provision of, and access
to, new or existing supportive services for
patients receiving a positive diagnosis for
Down syndrome or other prenatally or
postnatally diagnosed conditions, including—
(i) the establishment of a resource telephone hotline accessible to patients receiving a positive test result or to the parents of newly diagnosed infants with Down
syndrome and other diagnosed conditions;
(ii) the expansion and further development of the National Dissemination Center for Children with Disabilities, so that
such Center can more effectively conduct
outreach to new and expecting parents and
provide them with up-to-date information
on the range of outcomes for individuals
living with the diagnosed condition, including physical, developmental, educational, and psychosocial outcomes;
(iii) the expansion and further development of national and local peer-support
programs, so that such programs can more
effectively serve women who receive a
positive diagnosis for Down syndrome or
other prenatal conditions or parents of infants with a postnatally diagnosed condition;
(iv) the establishment of a national registry, or network of local registries, of
families willing to adopt newborns with
Down syndrome or other prenatally or
postnatally diagnosed conditions, and
links to adoption agencies willing to place
babies with Down syndrome or other prenatally or postnatally diagnosed conditions, with families willing to adopt; and
(v) the establishment of awareness and
education programs for health care providers who provide, interpret, or inform parents of the results of prenatal tests for
Down syndrome or other prenatally or
postnatally diagnosed conditions, to pa-

§ 280g–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tients, consistent with the purpose described in section 2(b)(1) 1 of the Prenatally
and Postnatally Diagnosed Conditions
Awareness Act.
(2) Eligible entity
In this subsection, the term ‘‘eligible entity’’ means—
(A) a State or a political subdivision of a
State;
(B) a consortium of 2 or more States or political subdivisions of States;
(C) a territory;
(D) a health facility or program operated
by or pursuant to a contract with or grant
from the Indian Health Service; or
(E) any other entity with appropriate expertise in prenatally and postnatally diagnosed conditions (including nationally recognized disability groups), as determined by
the Secretary.
(3) Distribution
In distributing funds under this subsection,
the Secretary shall place an emphasis on funding partnerships between health care professional groups and disability advocacy organizations.
(c) Provision of information to providers
(1) In general
A grantee under this section shall make
available to health care providers of parents
who receive a prenatal or postnatal diagnosis
the following:
(A) Up-to-date, evidence-based, written information concerning the range of outcomes
for individuals living with the diagnosed
condition, including physical, developmental, educational, and psychosocial outcomes.
(B) Contact information regarding support
services, including information hotlines specific to Down syndrome or other prenatally
or postnatally diagnosed conditions, resource centers or clearinghouses, national
and local peer support groups, and other education and support programs as described in
subsection (b)(2).
(2) Informational requirements
Information provided under this subsection
shall be—
(A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the family of infants receiving a postnatal diagnosis; and
(B) approved by the Secretary.
(d) Report
Not later than 2 years after October 8, 2008,
the Government Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and family support programs serving as resources for the families of children with disabilities.
(July 1, 1944, ch. 373, title III, § 399T, formerly
§ 399R, as added Pub. L. 110–374, § 3, Oct. 8, 2008,
122 Stat. 4051; renumbered § 399T, Pub. L. 111–148,
title IV, § 4003(b)(2)(B), Mar. 23, 2010, 124 Stat.
544.)
1 See

References in Text note below.

Page 458

REFERENCES IN TEXT
Section 2(b)(1) of the Prenatally and Postnatally Diagnosed Conditions Awareness Act, referred to in subsec. (b)(1)(B)(v), probably means section 2(1) of that
Act, Pub. L. 110–374, which is set out as a note under
this section.
PURPOSES
Pub. L. 110–374, § 2, Oct. 8, 2008, 122 Stat. 4051, provided
that: ‘‘It is the purpose of this Act [enacting this section and provisions set out as a note under section 201
of this title] to—
‘‘(1) increase patient referrals to providers of key
support services for women who have received a positive diagnosis for Down syndrome, or other prenatally or postnatally diagnosed conditions, as well
as to provide up-to-date information on the range of
outcomes for individuals living with the diagnosed
condition, including physical, developmental, educational, and psychosocial outcomes;
‘‘(2) strengthen existing networks of support
through the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and other patient and provider outreach programs; and
‘‘(3) ensure that patients receive up-to-date, evidence-based information about the accuracy of the
test.’’

§ 280g–9. Programs to improve quality of life for
persons with paralysis and other physical
disabilities
(a) In general
The Secretary of Health and Human Services
(in this section referred to as the ‘‘Secretary’’)
may study the unique health challenges associated with paralysis and other physical disabilities and carry out projects and interventions to
improve the quality of life and long-term health
status of persons with paralysis and other physical disabilities. The Secretary may carry out
such projects directly and through awards of
grants or contracts.
(b) Certain activities
Activities under subsection (a) may include—
(1) the development of a national paralysis
and physical disability quality of life action
plan, to promote health and wellness in order
to enhance full participation, independent living, self-sufficiency, and equality of opportunity in partnership with voluntary health
agencies focused on paralysis and other physical disabilities, to be carried out in coordination with the State-based Disability and
Health Program of the Centers for Disease
Control and Prevention;
(2) support for programs to disseminate information involving care and rehabilitation
options and quality of life grant programs supportive of community-based programs and
support systems for persons with paralysis and
other physical disabilities;
(3) in collaboration with other centers and
national voluntary health agencies, the establishment of a population-based database that
may be used for longitudinal and other research on paralysis and other disabling conditions; and
(4) the replication and translation of best
practices and the sharing of information
across States, as well as the development of
comprehensive, unique, and innovative pro-

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grams, services, and demonstrations within
existing State-based disability and health programs of the Centers for Disease Control and
Prevention which are designed to support and
advance quality of life programs for persons
living with paralysis and other physical disabilities focusing on—
(A) caregiver education;
(B) promoting proper nutrition, increasing
physical activity, and reducing tobacco use;
(C) education and awareness programs for
health care providers;
(D) prevention of secondary complications;
(E) home- and community-based interventions;
(F) coordinating services and removing
barriers that prevent full participation and
integration into the community; and
(G) recognizing the unique needs of underserved populations.
(c) Grants
The Secretary may award grants in accordance with the following:
(1) To State and local health and disability
agencies for the purpose of—
(A) establishing a population-based database that may be used for longitudinal and
other research on paralysis and other disabling conditions;
(B) developing comprehensive paralysis
and other physical disability action plans
and activities focused on the items listed in
subsection (b)(4);
(C) assisting State-based programs in establishing and implementing partnerships
and collaborations that maximize the input
and support of people with paralysis and
other physical disabilities and their constituent organizations;
(D) coordinating paralysis and physical
disability activities with existing Statebased disability and health programs;
(E) providing education and training opportunities and programs for health professionals and allied caregivers; and
(F) developing, testing, evaluating, and
replicating effective intervention programs
to maintain or improve health and quality
of life.
(2) To private health and disability organizations for the purpose of—
(A) disseminating information to the public;
(B) improving access to services for persons living with paralysis and other physical
disabilities and their caregivers;
(C) testing model intervention programs to
improve health and quality of life; and
(D) coordinating existing services with
State-based disability and health programs.
(d) Coordination of activities
The Secretary shall ensure that activities
under this section are coordinated as appropriate by the agencies of the Department of
Health and Human Services.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there is authorized to be appropriated $25,000,000
for each of fiscal years 2008 through 2011.

§ 280g–10

(Pub. L. 111–11, title XIV, § 14301, Mar. 30, 2009,
123 Stat. 1454.)
CODIFICATION
Section was enacted as part of the Christopher and
Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as
part of the Public Health Service Act which comprises
this chapter.

§ 280g–10. Community Preventive Services Task
Force
(a) Establishment and purpose
The Director of the Centers for Disease Control and Prevention shall convene an independent Community Preventive Services Task Force
(referred to in this subsection as the ‘‘Task
Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness
of community preventive interventions for the
purpose of developing recommendations, to be
published in the Guide to Community Preventive Services (referred to in this section as the
‘‘Guide’’), for individuals and organizations delivering population-based services, including
primary care professionals, health care systems,
professional societies, employers, community
organizations, non-profit organizations, schools,
governmental public health agencies, Indian
tribes, tribal organizations and urban Indian organizations, medical groups, Congress and other
policy-makers. Community preventive services
include any policies, programs, processes or activities designed to affect or otherwise affecting
health at the population level.
(b) Duties
The duties of the Task Force shall include—
(1) the development of additional topic areas
for new recommendations and interventions
related to those topic areas, including those
related to specific populations and age groups,
as well as the social, economic and physical
environments that can have broad effects on
the health and disease of populations and
health disparities among sub-populations and
age groups;
(2) at least once during every 5-year period,
review 1 interventions and update 1 recommendations related to existing topic areas, including new or improved techniques to assess
the health effects of interventions, including
health impact assessment and population
health modeling;
(3) improved integration with Federal Government health objectives and related target
setting for health improvement;
(4) the enhanced dissemination of recommendations;
(5) the provision of technical assistance to
those health care professionals, agencies, and
organizations that request help in implementing the Guide recommendations; and
(6) providing yearly reports to Congress and
related agencies identifying gaps in research
and recommending priority areas that deserve
further examination, including areas related
1 So

in original. Probably should be followed by ‘‘of’’.

§ 280g–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to populations and age groups not adequately
addressed by current recommendations.
(c) Role of agency
The Director shall provide ongoing administrative, research, and technical support for the
operations of the Task Force, including coordinating and supporting the dissemination of the
recommendations of the Task Force, ensuring
adequate staff resources, and assistance to those
organizations requesting it for implementation
of Guide recommendations.
(d) Coordination with Preventive Services Task
Force
The Task Force shall take appropriate steps
to coordinate its work with the U.S. Preventive
Services Task Force and the Advisory Committee on Immunization Practices, including the
examination of how each task force’s recommendations interact at the nexus of clinic and
community.
(e) Operation
In carrying out the duties under subsection
(b), the Task Force shall not be subject to the
provisions of Appendix 2 of title 5.
(f) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary for each fiscal year to
carry out the activities of the Task Force.
(July 1, 1944, ch. 373, title III, § 399U, as added
Pub. L. 111–148, title IV, § 4003(b)(1), Mar. 23, 2010,
124 Stat. 543.)
REFERENCES IN TEXT
Appendix 2 of title 5, referred to in subsec. (e), probably means the Federal Advisory Committee Act, Pub.
L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out in
the Appendix to Title 5, Government Organization and
Employees.

§ 280g–11. Grants to promote positive health behaviors and outcomes
(a) Grants authorized
The Director of the Centers for Disease Control and Prevention, in collaboration with the
Secretary, shall award grants to eligible entities
to promote positive health behaviors and outcomes for populations in medically underserved
communities through the use of community
health workers.
(b) Use of funds
Grants awarded under subsection (a) shall be
used to support community health workers—
(1) to educate, guide, and provide outreach
in a community setting regarding health problems prevalent in medically underserved communities, particularly racial and ethnic minority populations;
(2) to educate and provide guidance regarding effective strategies to promote positive
health behaviors and discourage risky health
behaviors;
(3) to educate and provide outreach regarding enrollment in health insurance including
the Children’s Health Insurance Program
under title XXI of the Social Security Act [42
U.S.C. 1397aa et seq.], Medicare under title
XVIII of such Act [42 U.S.C. 1395 et seq.] and

Page 460

Medicaid under title XIX of such Act [42 U.S.C.
1396 et seq.];
(4) to identify and refer underserved populations to appropriate healthcare agencies and
community-based programs and organizations
in order to increase access to quality healthcare services and to eliminate duplicative
care; or
(5) to educate, guide, and provide home visitation services regarding maternal health and
prenatal care.
(c) Application
Each eligible entity that desires to receive a
grant under subsection (a) shall submit an application to the Secretary, at such time, in such
manner, and accompanied by such information
as the Secretary may require.
(d) Priority
In awarding grants under subsection (a), the
Secretary shall give priority to applicants
that—
(1) propose to target geographic areas—
(A) with a high percentage of residents
who are eligible for health insurance but are
uninsured or underinsured;
(B) with a high percentage of residents
who suffer from chronic diseases; or
(C) with a high infant mortality rate;
(2) have experience in providing health or
health-related social services to individuals
who are underserved with respect to such services; and
(3) have documented community activity
and experience with community health workers.
(e) Collaboration with academic institutions and
the one-stop delivery system
The Secretary shall encourage community
health worker programs receiving funds under
this section to collaborate with academic institutions and one-stop delivery systems under section 2864(c) of title 29. Nothing in this section
shall be construed to require such collaboration.
(f) Evidence-based interventions
The Secretary shall encourage community
health worker programs receiving funding under
this section to implement a process or an outcome-based payment system that rewards community health workers for connecting underserved populations with the most appropriate
services at the most appropriate time. Nothing
in this section shall be construed to require such
a payment.
(g) Quality assurance and cost effectiveness
The Secretary shall establish guidelines for
assuring the quality of the training and supervision of community health workers under the
programs funded under this section and for assuring the cost-effectiveness of such programs.
(h) Monitoring
The Secretary shall monitor community
health worker programs identified in approved
applications under this section and shall determine whether such programs are in compliance
with the guidelines established under subsection
(g).
(i) Technical assistance
The Secretary may provide technical assistance to community health worker programs

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identified in approved applications under this
section with respect to planning, developing,
and operating programs under the grant.
(j) Authorization of appropriations
There are authorized to be appropriated, such
sums as may be necessary to carry out this section for each of fiscal years 2010 through 2014.
(k) Definitions
In this section:
(1) Community health worker
The term ‘‘community health worker’’
means an individual who promotes health or
nutrition within the community in which the
individual resides—
(A) by serving as a liaison between communities and healthcare agencies;
(B) by providing guidance and social assistance to community residents;
(C) by enhancing community residents’
ability to effectively communicate with
healthcare providers;
(D) by providing culturally and linguistically appropriate health or nutrition education;
(E) by advocating for individual and community health;
(F) by providing referral and follow-up
services or otherwise coordinating care; and
(G) by proactively identifying and enrolling eligible individuals in Federal, State,
local, private or nonprofit health and human
services programs.
(2) Community setting
The term ‘‘community setting’’ means a
home or a community organization located in
the neighborhood in which a participant in the
program under this section resides.
(3) Eligible entity
The term ‘‘eligible entity’’ means a public or
nonprofit private entity (including a State or
public subdivision of a State, a public health
department, a free health clinic, a hospital, or
a Federally-qualified health center (as defined
in section 1861(aa) of the Social Security Act
[42 U.S.C. 1395x(aa)])), or a consortium of any
such entities.
(4) Medically underserved community
The term ‘‘medically underserved community’’ means a community identified by a
State—
(A) that has a substantial number of individuals who are members of a medically underserved population, as defined by section
254b(b)(3) of this title; and
(B) a significant portion of which is a
health professional shortage area as designated under section 254e of this title.
(July 1, 1944, ch. 373, title III, § 399V, as added
and amended Pub. L. 111–148, title V, § 5313(a),
title X, § 10501(c), Mar. 23, 2010, 124 Stat. 633, 994.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(3),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII,
XIX, and XXI of the Act are classified generally to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.), and
XXI (§ 1397aa et seq.), respectively, of chapter 7 of this

§ 280g–12

title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
AMENDMENTS
2010—Subsec. (b)(4). Pub. L. 111–148, § 10501(c)(1), substituted ‘‘identify and refer’’ for ‘‘identify, educate,
refer, and enroll’’.
Subsec. (k)(1). Pub. L. 111–148, § 10501(c)(2), struck out
‘‘, as defined by the Department of Labor as Standard
Occupational Classification [21–1094]’’ before ‘‘means’’
in introductory provisions.

§ 280g–12. Primary Care Extension Program
(a) Establishment, purpose and definition
(1) In general
The Secretary, acting through the Director
of the Agency for Healthcare Research and
Quality, shall establish a Primary Care Extension Program.
(2) Purpose
The Primary Care Extension Program shall
provide support and assistance to primary
care providers to educate providers about preventive medicine, health promotion, chronic
disease management, mental and behavioral
health services (including substance abuse prevention and treatment services), and evidencebased and evidence-informed therapies and
techniques, in order to enable providers to incorporate such matters into their practice and
to improve community health by working
with community-based health connectors (referred to in this section as ‘‘Health Extension
Agents’’).
(3) Definitions
In this section:
(A) Health Extension Agent
The term ‘‘Health Extension Agent’’
means any local, community-based health
worker who facilitates and provides assistance to primary care practices by implementing quality improvement or system redesign, incorporating the principles of the
patient-centered medical home to provide
high-quality, effective, efficient, and safe
primary care and to provide guidance to patients in culturally and linguistically appropriate ways, and linking practices to diverse
health system resources.
(B) Primary care provider
The term ‘‘primary care provider’’ means a
clinician who provides integrated, accessible
health care services and who is accountable
for addressing a large majority of personal
health care needs, including providing preventive and health promotion services for
men, women, and children of all ages, developing a sustained partnership with patients,
and practicing in the context of family and
community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this section.
(b) Grants to establish State Hubs and local Primary Care Extension Agencies
(1) Grants
The Secretary shall award competitive
grants to States for the establishment of

§ 280g–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State- or multistate-level primary care Primary Care Extension Program State Hubs (referred to in this section as ‘‘Hubs’’).
(2) Composition of Hubs
A Hub established by a State pursuant to
paragraph (1)—
(A) shall consist of, at a minimum, the
State health department, the entity responsible for administering the State Medicaid
program (if other than the State health department), the State-level entity administering the Medicare program, and the departments that train providers in primary
care in 1 or more health professions schools
in the State; and
(B) may include entities such as hospital
associations, primary care practice-based research networks, health professional societies, State primary care associations, State
licensing boards, organizations with a contract with the Secretary under section
1320c–2 of this title, consumer groups, and
other appropriate entities.
(c) State and local activities
(1) Hub activities
Hubs established under a grant under subsection (b) shall—
(A) submit to the Secretary a plan to coordinate functions with quality improvement
organizations and area health education centers if such entities are members of the Hub
not described in subsection (b)(2)(A);
(B) contract with a county- or local-level
entity that shall serve as the Primary Care
Extension Agency to administer the services
described in paragraph (2);
(C) organize and administer grant funds to
county- or local-level Primary Care Extension Agencies that serve a catchment area,
as determined by the State; and
(D) organize State-wide or multistate networks of local-level Primary Care Extension
Agencies to share and disseminate information and practices.
(2) Local Primary Care Extension Agency activities
(A) Required activities
Primary Care Extension Agencies established by a Hub under paragraph (1) shall—
(i) assist primary care providers to implement a patient-centered medical home
to improve the accessibility, quality, and
efficiency of primary care services, including health homes;
(ii) develop and support primary care
learning communities to enhance the dissemination of research findings for evidence-based practice, assess implementation of practice improvement, share best
practices, and involve community clinicians in the generation of new knowledge
and identification of important questions
for research;
(iii) participate in a national network of
Primary Care Extension Hubs and propose
how the Primary Care Extension Agency
will share and disseminate lessons learned
and best practices; and

Page 462

(iv) develop a plan for financial sustainability involving State, local, and private
contributions, to provide for the reduction
in Federal funds that is expected after an
initial 6-year period of program establishment, infrastructure development, and
planning.
(B) Discretionary activities
Primary Care Extension Agencies established by a Hub under paragraph (1) may—
(i) provide technical assistance, training,
and organizational support for community
health teams established under section
256a–1 1 of this title;
(ii) collect data and provision of primary
care provider feedback from standardized
measurements of processes and outcomes
to aid in continuous performance improvement;
(iii) collaborate with local health departments, community health centers, tribes
and tribal entities, and other community
agencies to identify community health priorities and local health workforce needs,
and participate in community-based efforts to address the social and primary determinants of health, strengthen the local
primary care workforce, and eliminate
health disparities;
(iv) develop measures to monitor the impact of the proposed program on the health
of practice enrollees and of the wider community served; and
(v) participate in other activities, as determined appropriate by the Secretary.
(d) Federal program administration
(1) Grants; types
Grants awarded under subsection (b) shall
be—
(A) program grants, that are awarded to
State or multistate entities that submit
fully-developed plans for the implementation of a Hub, for a period of 6 years; or
(B) planning grants, that are awarded to
State or multistate entities with the goal of
developing a plan for a Hub, for a period of
2 years.
(2) Applications
To be eligible for a grant under subsection
(b), a State or multistate entity shall submit
to the Secretary an application, at such time,
in such manner, and containing such information as the Secretary may require.
(3) Evaluation
A State that receives a grant under subsection (b) shall be evaluated at the end of the
grant period by an evaluation panel appointed
by the Secretary.
(4) Continuing support
After the sixth year in which assistance is
provided to a State under a grant awarded
under subsection (b), the State may receive
additional support under this section if the
State program has received satisfactory evaluations with respect to program performance
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and the merits of the State sustainability
plan, as determined by the Secretary.
(5) Limitation
A State shall not use in excess of 10 percent
of the amount received under a grant to carry
out administrative activities under this section. Funds awarded pursuant to this section
shall not be used for funding direct patient
care.
(e) Requirements on the Secretary
In carrying out this section, the Secretary
shall consult with the heads of other Federal
agencies with demonstrated experience and expertise in health care and preventive medicine,
such as the Centers for Disease Control and Prevention, the Substance Abuse and Mental
Health Administration, the Health Resources
and Services Administration, the National Institutes of Health, the Office of the National Coordinator for Health Information Technology,
the Indian Health Service, the Agricultural Cooperative Extension Service of the Department
of Agriculture, and other entities, as the Secretary determines appropriate.
(f) Authorization of appropriations
To awards grants as provided in subsection (d),
there are authorized to be appropriated
$120,000,000 for each of fiscal years 2011 and 2012,
and such sums as may be necessary to carry out
this section for each of fiscal years 2013 through
2014.
(July 1, 1944, ch. 373, title III, § 399V–1, formerly
§ 399W, as added, amended, and renumbered
§ 399V–1, Pub. L. 111–148, title V, § 5405, title X,
§ 10501(f)(1), (2), Mar. 23, 2010, 124 Stat. 649, 996.)
REFERENCES IN TEXT
Section 256a–1 of this title, referred to in subsec.
(c)(2)(B)(i), was in the original ‘‘section 3602 of the Patient Protection and Affordable Care Act’’, and was
translated as meaning section 3502 of the Patient Protection and Affordable Care Act, Pub. L. 111–148, to reflect the probable intent of Congress.
AMENDMENTS
2010—Subsec. (b)(2)(A). Pub. L. 111–148, § 10501(f)(2),
substituted ‘‘and the departments that train providers
in primary care in 1 or more health professions schools
in the State’’ for ‘‘and the departments of 1 or more
health professions schools in the State that train providers in primary care’’.

§ 280g–13. National Congenital Heart Disease
Surveillance System
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may—
(1) enhance and expand infrastructure to
track the epidemiology of congenital heart
disease and to organize such information into
a nationally-representative, population-based
surveillance system that compiles data concerning actual occurrences of congenital heart
disease, to be known as the ‘‘National Congenital Heart Disease Surveillance System’’;
or
(2) award a grant to one eligible entity to
undertake the activities described in paragraph (1).

§ 280g–13

(b) Purpose
The purpose of the Congenital Heart Disease
Surveillance System shall be to facilitate further research into the types of health services
patients use and to identify possible areas for
educational outreach and prevention in accordance with standard practices of the Centers for
Disease Control and Prevention.
(c) Content
The Congenital Heart Disease Surveillance
System—
(1) may include information concerning the
incidence and prevalence of congenital heart
disease in the United States;
(2) may be used to collect and store data on
congenital heart disease, including data concerning—
(A) demographic factors associated with
congenital heart disease, such as age, race,
ethnicity, sex, and family history of individuals who are diagnosed with the disease;
(B) risk factors associated with the disease;
(C) causation of the disease;
(D) treatment approaches; and
(E) outcome measures, such that analysis
of the outcome measures will allow derivation of evidence-based best practices and
guidelines for congenital heart disease patients; and
(3) may ensure the collection and analysis of
longitudinal data related to individuals of all
ages with congenital heart disease, including
infants, young children, adolescents, and
adults of all ages.
(d) Public access
The Congenital Heart Disease Surveillance
System shall be made available to the public, as
appropriate, including congenital heart disease
researchers.
(e) Patient privacy
The Secretary shall ensure that the Congenital Heart Disease Surveillance System is maintained in a manner that complies with the regulations promulgated under section 264 of the
Health Insurance Portability and Accountability Act of 1996.
(f) Eligibility for grant
To be eligible to receive a grant under subsection (a)(2), an entity shall—
(1) be a public or private nonprofit entity
with specialized experience in congenital heart
disease; and
(2) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require.
(July 1, 1944, ch. 373, title III, § 399V–2, as added
Pub. L. 111–148, title X, § 10411(b)(1), Mar. 23, 2010,
124 Stat. 988.)
REFERENCES IN TEXT
Section 264 of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (e), is
section 264 of Pub. L. 104–191, which is set out as a note
under section 1320d–2 of this title.

§ 280g–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 280g–14. National diabetes prevention program
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish a national diabetes prevention
program (referred to in this section as the ‘‘program’’) targeted at adults at high risk for diabetes in order to eliminate the preventable burden
of diabetes.
(b) Program activities
The program described in subsection (a) shall
include—
(1) a grant program for community-based diabetes prevention program model sites;
(2) a program within the Centers for Disease
Control and Prevention to determine eligibility of entities to deliver community-based
diabetes prevention services;
(3) a training and outreach program for lifestyle intervention instructors; and
(4) evaluation, monitoring and technical assistance, and applied research carried out by
the Centers for Disease Control and Prevention.
(c) Eligible entities
To be eligible for a grant under subsection
(b)(1), an entity shall be a State or local health
department, a tribal organization, a national
network of community-based non-profits focused on health and wellbeing, an academic institution, or other entity, as the Secretary determines.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 399V–3, as added
Pub. L. 111–148, title X, § 10501(g), Mar. 23, 2010,
124 Stat. 996.)
§ 280g–15. State demonstration programs to
evaluate alternatives to current medical tort
litigation
(a) In general
The Secretary is authorized to award demonstration grants to States for the development,
implementation, and evaluation of alternatives
to current tort litigation for resolving disputes
over injuries allegedly caused by health care
providers or health care organizations. In
awarding such grants, the Secretary shall ensure the diversity of the alternatives so funded.
(b) Duration
The Secretary may award grants under subsection (a) for a period not to exceed 5 years.
(c) Conditions for demonstration grants
(1) Requirements
Each State desiring a grant under subsection
(a) shall develop an alternative to current tort
litigation that—
(A) allows for the resolution of disputes
over injuries allegedly caused by health care
providers or health care organizations; and
(B) promotes a reduction of health care errors by encouraging the collection and

Page 464

analysis of patient safety data related to
disputes resolved under subparagraph (A) by
organizations that engage in efforts to improve patient safety and the quality of
health care.
(2) Alternative to current tort litigation
Each State desiring a grant under subsection
(a) shall demonstrate how the proposed alternative described in paragraph (1)(A)—
(A) makes the medical liability system
more reliable by increasing the availability
of prompt and fair resolution of disputes;
(B) encourages the efficient resolution of
disputes;
(C) encourages the disclosure of health
care errors;
(D) enhances patient safety by detecting,
analyzing, and helping to reduce medical errors and adverse events;
(E) improves access to liability insurance;
(F) fully informs patients about the differences in the alternative and current tort
litigation;
(G) provides patients the ability to opt out
of or voluntarily withdraw from participating in the alternative at any time and to
pursue other options, including litigation,
outside the alternative;
(H) would not conflict with State law at
the time of the application in a way that
would prohibit the adoption of an alternative to current tort litigation; and
(I) would not limit or curtail a patient’s
existing legal rights, ability to file a claim
in or access a State’s legal system, or otherwise abrogate a patient’s ability to file a
medical malpractice claim.
(3) Sources of compensation
Each State desiring a grant under subsection
(a) shall identify the sources from and methods by which compensation would be paid for
claims resolved under the proposed alternative
to current tort litigation, which may include
public or private funding sources, or a combination of such sources. Funding methods shall
to the extent practicable provide financial incentives for activities that improve patient
safety.
(4) Scope
(A) In general
Each State desiring a grant under subsection (a) shall establish a scope of jurisdiction (such as Statewide, designated geographic region, a designated area of health
care practice, or a designated group of
health care providers or health care organizations) for the proposed alternative to current tort litigation that is sufficient to
evaluate the effects of the alternative. No
scope of jurisdiction shall be established
under this paragraph that is based on a
health care payer or patient population.
(B) Notification of patients
A State shall demonstrate how patients
would be notified that they are receiving
health care services that fall within such
scope, and the process by which they may
opt out of or voluntarily withdraw from par-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ticipating in the alternative. The decision of
the patient whether to participate or continue participating in the alternative process shall be made at any time and shall not
be limited in any way.
(5) Preference in awarding demonstration
grants
In awarding grants under subsection (a), the
Secretary shall give preference to States—
(A) that have developed the proposed alternative through substantive consultation
with relevant stakeholders, including patient advocates, health care providers and
health care organizations, attorneys with
expertise in representing patients and health
care providers, medical malpractice insurers, and patient safety experts;
(B) that make proposals that are likely to
enhance patient safety by detecting, analyzing, and helping to reduce medical errors
and adverse events; and
(C) that make proposals that are likely to
improve access to liability insurance.
(d) Application
(1) In general
Each State desiring a grant under subsection
(a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary
may require.
(2) Review panel
(A) In general
In reviewing applications under paragraph
(1), the Secretary shall consult with a review
panel composed of relevant experts appointed by the Comptroller General.
(B) Composition
(i) Nominations
The Comptroller General shall solicit
nominations from the public for individuals to serve on the review panel.
(ii) Appointment
The Comptroller General shall appoint,
at least 9 but not more than 13, highly
qualified and knowledgeable individuals to
serve on the review panel and shall ensure
that the following entities receive fair representation on such panel:
(I) Patient advocates.
(II) Health care providers and health
care organizations.
(III) Attorneys with expertise in representing patients and health care providers.
(IV) Medical malpractice insurers.
(V) State officials.
(VI) Patient safety experts.
(C) Chairperson
The Comptroller General, or an individual
within the Government Accountability Office designated by the Comptroller General,
shall be the chairperson of the review panel.
(D) Availability of information
The Comptroller General shall make available to the review panel such information,

§ 280g–15

personnel, and administrative services and
assistance as the review panel may reasonably require to carry out its duties.
(E) Information from agencies
The review panel may request directly
from any department or agency of the
United States any information that such
panel considers necessary to carry out its
duties. To the extent consistent with applicable laws and regulations, the head of such
department or agency shall furnish the requested information to the review panel.
(e) Reports
(1) By State
Each State receiving a grant under subsection (a) shall submit to the Secretary an
annual report evaluating the effectiveness of
activities funded with grants awarded under
such subsection. Such report shall, at a minimum, include the impact of the activities
funded on patient safety and on the availability and price of medical liability insurance.
(2) By Secretary
The Secretary shall submit to Congress an
annual compendium of the reports submitted
under paragraph (1) and an analysis of the activities funded under subsection (a) that examines any differences that result from such activities in terms of the quality of care, number
and nature of medical errors, medical resources used, length of time for dispute resolution, and the availability and price of liability
insurance.
(f) Technical assistance
(1) In general
The Secretary shall provide technical assistance to the States applying for or awarded
grants under subsection (a).
(2) Requirements
Technical assistance under paragraph (1)
shall include—
(A) guidance on non-economic damages,
including the consideration of individual
facts and circumstances in determining appropriate payment, guidance on identifying
avoidable injuries, and guidance on disclosure to patients of health care errors and adverse events; and
(B) the development, in consultation with
States, of common definitions, formats, and
data collection infrastructure for States receiving grants under this section to use in
reporting to facilitate aggregation and
analysis of data both within and between
States.
(3) Use of common definitions, formats, and
data collection infrastructure
States not receiving grants under this section may also use the common definitions, formats, and data collection infrastructure developed under paragraph (2)(B).
(g) Evaluation
(1) In general
The Secretary, in consultation with the review panel established under subsection (d)(2),

§ 280g–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall enter into a contract with an appropriate
research organization to conduct an overall
evaluation of the effectiveness of grants
awarded under subsection (a) and to annually
prepare and submit a report to Congress. Such
an evaluation shall begin not later than 18
months following the date of implementation
of the first program funded by a grant under
subsection (a).
(2) Contents
The evaluation under paragraph (1) shall include—
(A) an analysis of the effects of the grants
awarded under subsection (a) with regard to
the measures described in paragraph (3);
(B) for each State, an analysis of the extent to which the alternative developed
under subsection (c)(1) is effective in meeting the elements described in subsection
(c)(2);
(C) a comparison among the States receiving grants under subsection (a) of the effectiveness of the various alternatives developed by such States under subsection (c)(1);
(D) a comparison, considering the measures described in paragraph (3), of States receiving grants approved under subsection (a)
and similar States not receiving such grants;
and
(E) a comparison, with regard to the measures described in paragraph (3), of—
(i) States receiving grants under subsection (a);
(ii) States that enacted, prior to March
23, 2010, any cap on non-economic damages;
and
(iii) States that have enacted, prior to
March 23, 2010, a requirement that the
complainant obtain an opinion regarding
the merit of the claim, although the substance of such opinion may have no bearing on whether the complainant may proceed with a case.
(3) Measures
The evaluations under paragraph (2) shall
analyze and make comparisons on the basis
of—
(A) the nature and number of disputes over
injuries allegedly caused by health care providers or health care organizations;
(B) the nature and number of claims in
which tort litigation was pursued despite the
existence of an alternative under subsection
(a);
(C) the disposition of disputes and claims,
including the length of time and estimated
costs to all parties;
(D) the medical liability environment;
(E) health care quality;
(F) patient safety in terms of detecting,
analyzing, and helping to reduce medical errors and adverse events;
(G) patient and health care provider and
organization satisfaction with the alternative under subsection (a) and with the
medical liability environment; and
(H) impact on utilization of medical services, appropriately adjusted for risk.

Page 466

(4) Funding
The Secretary shall reserve 5 percent of the
amount appropriated in each fiscal year under
subsection (k) to carry out this subsection.
(h) MedPAC and MACPAC reports
(1) MedPAC
The Medicare Payment Advisory Commission shall conduct an independent review of
the alternatives to current tort litigation that
are implemented under grants under subsection (a) to determine the impact of such alternatives on the Medicare program under
title XVIII of the Social Security Act [42
U.S.C. 1395 et seq.], and its beneficiaries.
(2) MACPAC
The Medicaid and CHIP Payment and Access
Commission shall conduct an independent review of the alternatives to current tort litigation that are implemented under grants under
subsection (a) to determine the impact of such
alternatives on the Medicaid or CHIP programs under titles XIX and XXI of the Social
Security Act [42 U.S.C. 1396 et seq., 1397aa et
seq.], and their beneficiaries.
(3) Reports
Not later than December 31, 2016, the Medicare Payment Advisory Commission and the
Medicaid and CHIP Payment and Access Commission shall each submit to Congress a report
that includes the findings and recommendations of each respective Commission based on
independent reviews conducted under paragraphs (1) and (2), including an analysis of the
impact of the alternatives reviewed on the efficiency and effectiveness of the respective
programs.
(i) Option to provide for initial planning grants
Of the funds appropriated pursuant to subsection (k), the Secretary may use a portion not
to exceed $500,000 per State to provide planning
grants to such States for the development of
demonstration project applications meeting the
criteria described in subsection (c). In selecting
States to receive such planning grants, the Secretary shall give preference to those States in
which State law at the time of the application
would not prohibit the adoption of an alternative to current tort litigation.
(j) Definitions
In this section:
(1) Health care services
The term ‘‘health care services’’ means any
services provided by a health care provider, or
by any individual working under the supervision of a health care provider, that relate
to—
(A) the diagnosis, prevention, or treatment
of any human disease or impairment; or
(B) the assessment of the health of human
beings.
(2) Health care organization
The term ‘‘health care organization’’ means
any individual or entity which is obligated to
provide, pay for, or administer health benefits
under any health plan.
(3) Health care provider
The term ‘‘health care provider’’ means any
individual or entity—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) licensed, registered, or certified under
Federal or State laws or regulations to provide health care services; or
(B) required to be so licensed, registered,
or certified but that is exempted by other
statute or regulation.
(k) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $50,000,000 for the 5-fiscal
year period beginning with fiscal year 2011.
(l) Current State efforts to establish alternative
to tort litigation
Nothing in this section shall be construed to
limit any prior, current, or future efforts of any
State to establish any alternative to tort litigation.
(m) Rule of construction
Nothing in this section shall be construed as
limiting states’ 1 authority over or responsibility for their state 1 justice systems.
(July 1, 1944, ch. 373, title III, § 399V–4, as added
Pub. L. 111–148, title X, § 10607, Mar. 23, 2010, 124
Stat. 1009.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (h)(1),
(2), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles
XVIII, XIX, and XXI of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of
this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.

§ 280g–16. Food Safety Integrated Centers of Excellence
(a) In general
Not later than 1 year after January 4, 2011, the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention and
in consultation with the working group described in subsection (b)(2), shall designate 5 Integrated Food Safety Centers of Excellence (referred to in this section as the ‘‘Centers of Excellence’’) to serve as resources for Federal,
State, and local public health professionals to
respond to foodborne illness outbreaks. The Centers of Excellence shall be headquartered at selected State health departments.
(b) Selection of Centers of Excellence
(1) Eligible entities
To be eligible to be designated as a Center of
Excellence under subsection (a), an entity
shall—
(A) be a State health department;
(B) partner with 1 or more institutions of
higher education that have demonstrated
knowledge, expertise, and meaningful experience with regional or national food production, processing, and distribution, as well as
leadership in the laboratory, epidemiological, and environmental detection and investigation of foodborne illness; and
(C) provide to the Secretary such information, at such time, and in such manner, as
the Secretary may require.
(2) Working group
Not later than 180 days after January 4, 2011,
the Secretary shall establish a diverse work1 So

in original. Probably should be capitalized.

§ 280g–16

ing group of experts and stakeholders from
Federal, State, and local food safety and
health agencies, the food industry, including
food retailers and food manufacturers, consumer organizations, and academia to make
recommendations to the Secretary regarding
designations of the Centers of Excellence.
(3) Additional Centers of Excellence
The Secretary may designate eligible entities to be regional Food Safety Centers of Excellence, in addition to the 5 Centers designated under subsection (a).
(c) Activities
Under the leadership of the Director of the
Centers for Disease Control and Prevention,
each Center of Excellence shall be based out of
a selected State health department, which shall
provide assistance to other regional, State, and
local departments of health through activities
that include—
(1) providing resources, including timely information concerning symptoms and tests, for
frontline health professionals interviewing individuals as part of routine surveillance and
outbreak investigations;
(2) providing analysis of the timeliness and
effectiveness of foodborne disease surveillance
and outbreak response activities;
(3) providing training for epidemiological
and environmental investigation of foodborne
illness, including suggestions for streamlining
and standardizing the investigation process;
(4) establishing fellowships, stipends, and
scholarships to train future epidemiological
and food-safety leaders and to address critical
workforce shortages;
(5) training and coordinating State and local
personnel;
(6) strengthening capacity to participate in
existing or new foodborne illness surveillance
and environmental assessment information
systems; and
(7) conducting research and outreach activities focused on increasing prevention, communication, and education regarding food safety.
(d) Report to Congress
Not later than 2 years after January 4, 2011,
the Secretary shall submit to Congress a report
that—
(1) describes the effectiveness of the Centers
of Excellence; and
(2) provides legislative recommendations or
describes additional resources required by the
Centers of Excellence.
(e) Authorization of appropriations
There is authorized to be appropriated such
sums as may be necessary to carry out this section.
(f) No duplication of effort
In carrying out activities of the Centers of Excellence or other programs under this section,
the Secretary shall not duplicate other Federal
foodborne illness response efforts.
(July 1, 1944, ch. 373, title III, § 399V–5, as added
Pub. L. 111–353, title II, § 210(b), Jan. 4, 2011, 124
Stat. 3950.)

§ 280h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART Q—PROGRAMS TO IMPROVE THE HEALTH
OF CHILDREN
§ 280h. Grants to promote childhood nutrition
and physical activity
(a) In general
The Secretary, acting though the Director of
the Centers for Disease Control and Prevention,
shall award competitive grants to States and political subdivisions of States for the development and implementation of State and community-based intervention programs to promote
good nutrition and physical activity in children
and adolescents.
(b) Eligibility
To be eligible to receive a grant under this
section a State or political subdivision of a
State shall prepare and submit to the Secretary
an application at such time, in such manner,
and containing such information as the Secretary may require, including a plan that describes—
(1) how the applicant proposes to develop a
comprehensive program of school- and community-based approaches to encourage and promote good nutrition and appropriate levels of
physical activity with respect to children or
adolescents in local communities;
(2) the manner in which the applicant shall
coordinate with appropriate State and local
authorities, such as State and local school departments, State departments of health,
chronic disease directors, State directors of
programs under section 1786 of this title, 5-aday coordinators, governors councils for physical activity and good nutrition, and State and
local parks and recreation departments; and
(3) the manner in which the applicant will
evaluate the effectiveness of the program carried out under this section.
(c) Use of funds
A State or political subdivision of a State
shall use amount received under a grant under
this section to—
(1) develop, implement, disseminate, and
evaluate school- and community-based strategies in States to reduce inactivity and improve dietary choices among children and adolescents;
(2) expand opportunities for physical activity programs in school- and community-based
settings; and
(3) develop, implement, and evaluate programs that promote good eating habits and
physical activity including opportunities for
children with cognitive and physical disabilities.
(d) Technical assistance
The Secretary may set-aside an amount not to
exceed 10 percent of the amount appropriated for
a fiscal year under subsection (h) of this section
to permit the Director of the Centers for Disease
Control and Prevention to—
(1) provide States and political subdivisions
of States with technical support in the development and implementation of programs
under this section; and
(2) disseminate information about effective
strategies and interventions in preventing and

Page 468

treating obesity through the promotion of
good nutrition and physical activity.
(e) Limitation on administrative costs
Not to exceed 10 percent of the amount of a
grant awarded to the State or political subdivision under subsection (a) of this section for a fiscal year may be used by the State or political
subdivision for administrative expenses.
(f) Term
A grant awarded under subsection (a) of this
section shall be for a term of 3 years.
(g) Definition
In this section, the term ‘‘children and adolescents’’ means individuals who do not exceed 18
years of age.
(h) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of the fiscal years 2001 through
2005.
(July 1, 1944, ch. 373, title III, § 399W, as added
Pub. L. 106–310, div. A, title XXIV, § 2401, Oct. 17,
2000, 114 Stat. 1158.)
CODIFICATION
Another section 399W of act July 1, 1944, was renumbered section 399V–1 and is classified to section 280g–12
of this title.

§ 280h–1. Applied research program
(a) In general
The Secretary, acting through the Centers for
Disease Control and Prevention and in consultation with the Director of the National Institutes
of Health, shall—
(1) conduct research to better understand
the relationship between physical activity,
diet, and health and factors that influence
health-related behaviors;
(2) develop and evaluate strategies for the
prevention and treatment of obesity to be used
in community-based interventions and by
health professionals;
(3) develop and evaluate strategies for the
prevention and treatment of eating disorders,
such as anorexia and bulimia;
(4) conduct research to establish the prevalence, consequences, and costs of childhood
obesity and its effects in adulthood;
(5) identify behaviors and risk factors that
contribute to obesity;
(6) evaluate materials and programs to provide nutrition education to parents and teachers of children in child care or pre-school and
the food service staff of such child care and
pre-school entities; and
(7) evaluate materials and programs that are
designed to educate and encourage physical
activity in child care and pre-school facilities.
(b) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of the fiscal years 2001 through
2005.
(July 1, 1944, ch. 373, title III, § 399X, as added
Pub. L. 106–310, div. A, title XXIV, § 2401, Oct. 17,
2000, 114 Stat. 1159.)

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 280h–2. Education campaign
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
and in collaboration with national, State, and
local partners, physical activity organizations,
nutrition experts, and health professional organizations, shall develop a national public campaign to promote and educate children and their
parents concerning—
(1) the health risks associated with obesity,
inactivity, and poor nutrition;
(2) ways in which to incorporate physical activity into daily living; and
(3) the benefits of good nutrition and strategies to improve eating habits.
(b) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of the fiscal years 2001 through
2005.
(July 1, 1944, ch. 373, title III, § 399Y, as added
Pub. L. 106–310, div. A, title XXIV, § 2401, Oct. 17,
2000, 114 Stat. 1160.)
§ 280h–3. Health
training

professional

education

and

(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
in collaboration with the Administrator of the
Health Resources and Services Administration
and the heads of other agencies, and in consultation with appropriate health professional associations, shall develop and carry out a program
to educate and train health professionals in effective strategies to—
(1) better identify and assess patients with
obesity or an eating disorder or patients atrisk of becoming obese or developing an eating
disorder;
(2) counsel, refer, or treat patients with obesity or an eating disorder; and
(3) educate patients and their families about
effective strategies to improve dietary habits
and establish appropriate levels of physical activity.
(b) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of the fiscal years 2001 through
2005.
(July 1, 1944, ch. 373, title III, § 399Z, as added
Pub. L. 106–310, div. A, title XXIV, § 2401, Oct. 17,
2000, 114 Stat. 1160.)
§ 280h–4. Grants for the establishment of schoolbased health centers
(1) Program
The Secretary of Health and Human Services
(in this section referred to as the ‘‘Secretary’’)
shall establish a program to award grants to eligible entities to support the operation of schoolbased health centers.
(2) Eligibility
To be eligible for a grant under this section,
an entity shall—

§ 280h–5

(A) be a school-based health center or a
sponsoring facility of a school-based health
center; and
(B) submit an application at such time, in
such manner, and containing such information
as the Secretary may require, including at a
minimum an assurance that funds awarded
under the grant shall not be used to provide
any service that is not authorized or allowed
by Federal, State, or local law.
(3) Preference
In awarding grants under this section,1 the
Secretary shall give preference to awarding
grants for school-based health centers that serve
a large population of children eligible for medical assistance under the State Medicaid plan
under title XIX of the Social Security Act [42
U.S.C. 1396 et seq.] or under a waiver of such
plan or children eligible for child health assistance under the State child health plan under
title XXI of that Act (42 U.S.C. 1397aa et seq.).
(4) Limitation on use of funds
An eligible entity shall use funds provided
under a grant awarded under this section only
for expenditures for facilities (including the acquisition or improvement of land, or the acquisition, construction, expansion, replacement, or
other improvement of any building or other facility), equipment, or similar expenditures, as
specified by the Secretary. No funds provided
under a grant awarded under this section 1 shall
be used for expenditures for personnel or to provide health services.
(5) Appropriations
Out of any funds in the Treasury not otherwise appropriated, there is appropriated for each
of fiscal years 2010 through 2013, $50,000,000 for
the purpose of carrying out this section. Funds
appropriated under this paragraph shall remain
available until expended.
(6) Definitions
In this section, the terms ‘‘school-based health
center’’ and ‘‘sponsoring facility’’ have the
meanings given those terms in section 2110(c)(9)
of the Social Security Act (42 U.S.C. 1397jj(c)(9)).
(Pub. L. 111–148, title IV, § 4101(a), Mar. 23, 2010,
124 Stat. 546.)
REFERENCES IN TEXT
This section, referred to in par. (3) and in par. (4) the
second place it appears, was in the original ‘‘this section’’, meaning section 4101 of Pub. L. 111–148, which enacted this section and section 280h–5 of this title.
The Social Security Act, referred to in par. (3), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XIX and XXI
of the Act are classified generally to subchapters XIX
(§ 1396 et seq.) and XXI (§ 1397aa et seq.), respectively, of
chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

§ 280h–5. School-based health centers
(a) Definitions; establishment of criteria
In this section:
1 See

References in Text note below.

§ 280h–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) Comprehensive primary health services
The term ‘‘comprehensive primary health
services’’ means the core services offered by
school-based health centers, which shall include the following:
(A) Physical
Comprehensive health assessments, diagnosis, and treatment of minor, acute, and
chronic medical conditions, and referrals to,
and follow-up for, specialty care and oral
and vision health services.
(B) Mental health
Mental health and substance use disorder
assessments, crisis intervention, counseling,
treatment, and referral to a continuum of
services including emergency psychiatric
care, community support programs, inpatient care, and outpatient programs.
(2) Medically underserved children and adolescents
(A) In general
The term ‘‘medically underserved children
and adolescents’’ means a population of children and adolescents who are residents of an
area designated as a medically underserved
area or a health professional shortage area
by the Secretary.
(B) Criteria
The Secretary shall prescribe criteria for
determining the specific shortages of personal health services for medically underserved children and adolescents under subparagraph (A) that shall—
(i) take into account any comments received by the Secretary from the chief executive officer of a State and local officials in a State; and
(ii) include factors indicative of the
health status of such children and adolescents of an area, including the ability of
the residents of such area to pay for health
services, the accessibility of such services,
the availability of health professionals to
such children and adolescents, and other
factors as determined appropriate by the
Secretary.
(3) School-based health center
The term ‘‘school-based health center’’
means a health clinic that—
(A) meets the definition of a school-based
health center under section 1397jj(c)(9)(A) of
this title and is administered by a sponsoring
facility
(as
defined
in
section
1397jj(c)(9)(B) of this title);
(B) provides, at a minimum, comprehensive primary health services during school
hours to children and adolescents by health
professionals in accordance with established
standards, community practice, reporting
laws, and other State laws, including parental consent and notification laws that are
not inconsistent with Federal law; and
(C) does not perform abortion services.
(b) Authority to award grants
The Secretary shall award grants for the costs
of the operation of school-based health centers

Page 470

(referred to in this section as ‘‘SBHCs’’) that
meet the requirements of this section.
(c) Applications
To be eligible to receive a grant under this
section, an entity shall—
(1) be an SBHC (as defined in subsection
(a)(3)); and
(2) submit to the Secretary an application at
such time, in such manner, and containing—
(A) evidence that the applicant meets all
criteria necessary to be designated an SBHC;
(B) evidence of local need for the services
to be provided by the SBHC;
(C) an assurance that—
(i) SBHC services will be provided to
those children and adolescents for whom
parental or guardian consent has been obtained in cooperation with Federal, State,
and local laws governing health care service provision to children and adolescents;
(ii) the SBHC has made and will continue
to make every reasonable effort to establish and maintain collaborative relationships with other health care providers in
the catchment area of the SBHC;
(iii) the SBHC will provide on-site access
during the academic day when school is in
session and 24-hour coverage through an
on-call system and through its backup
health providers to ensure access to services on a year-round basis when the school
or the SBHC is closed;
(iv) the SBHC will be integrated into the
school environment and will coordinate
health services with school personnel, such
as administrators, teachers, nurses, counselors, and support personnel, as well as
with other community providers co-located at the school;
(v) the SBHC sponsoring facility assumes
all responsibility for the SBHC administration, operations, and oversight; and
(vi) the SBHC will comply with Federal,
State, and local laws concerning patient
privacy and student records, including regulations promulgated under the Health Insurance Portability and Accountability
Act of 1996 and section 1232g of title 20; and
(D) such other information as the Secretary may require.
(d) Preferences and consideration
In reviewing applications:
(1) The Secretary may give preference to applicants who demonstrate an ability to serve
the following:
(A) Communities that have evidenced barriers to primary health care and mental
health and substance use disorder prevention
services for children and adolescents.
(B) Communities with high per capita
numbers of children and adolescents who are
uninsured, underinsured, or enrolled in public health insurance programs.
(C) Populations of children and adolescents that have historically demonstrated
difficulty in accessing health and mental
health and substance use disorder prevention
services.
(2) The Secretary may give consideration to
whether an applicant has received a grant
under section 280h–4 of this title.

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(e) Waiver of requirements
The Secretary may—
(1) under appropriate circumstances, waive
the application of all or part of the requirements of this subsection with respect to an
SBHC for not to exceed 2 years; and
(2) upon a showing of good cause, waive the
requirement that the SBHC provide all required comprehensive primary health services
for a designated period of time to be determined by the Secretary.
(f) Use of funds
(1) Funds
Funds awarded under a grant under this section—
(A) may be used for—
(i) acquiring and leasing equipment (including the costs of amortizing the principle of, and paying interest on, loans for
such equipment);
(ii) providing training related to the provision of required comprehensive primary
health services and additional health services;
(iii) the management and operation of
health center programs;
(iv) the payment of salaries for physicians, nurses, and other personnel of the
SBHC; and
(B) may not be used to provide abortions.
(2) Construction
The Secretary may award grants which may
be used to pay the costs associated with expanding and modernizing existing buildings
for use as an SBHC, including the purchase of
trailers or manufactured buildings to install
on the school property.
(3) Limitations
(A) In general
Any provider of services that is determined by a State to be in violation of a
State law described in subsection (a)(3)(B)
with respect to activities carried out at a 1
SBHC shall not be eligible to receive additional funding under this section.
(B) No overlapping grant period
No entity that has received funding under
section 254b of this title for a grant period
shall be eligible for a grant under this section for with respect to 1 the same grant period.
(g) Matching requirement
(1) In general
Each eligible entity that receives a grant
under this section shall provide, from nonFederal sources, an amount equal to 20 percent
of the amount of the grant (which may be provided in cash or in-kind) to carry out the activities supported by the grant.
(2) Waiver
The Secretary may waive all or part of the
matching requirement described in paragraph
(1) for any fiscal year for the SBHC if the Sec1 So

in original.

§ 280i

retary determines that applying the matching
requirement to the SBHC would result in serious hardship or an inability to carry out the
purposes of this section.
(h) Supplement, not supplant
Grant funds provided under this section shall
be used to supplement, not supplant, other Federal or State funds.
(i) Evaluation
The Secretary shall develop and implement a
plan for evaluating SBHCs and monitoring quality performance under the awards made under
this section.
(j) Age appropriate services
An eligible entity receiving funds under this
section shall only provide age appropriate services through a 1 SBHC funded under this section
to an individual.
(k) Parental consent
An eligible entity receiving funds under this
section shall not provide services through a 1
SBHC funded under this section to an individual
without the consent of the parent or guardian of
such individual if such individual is considered a
minor under applicable State law.
(l) Authorization of appropriations
For purposes of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 399Z–1, as added
and amended Pub. L. 111–148, title IV, § 4101(b),
title X, § 10402(a), Mar. 23, 2010, 124 Stat. 547, 975.)
REFERENCES IN TEXT
The Health Insurance Portability and Accountability
Act of 1996, referred to in subsec. (c)(2)(C)(vi), is Pub. L.
104–191, Aug. 21, 1996, 110 Stat. 1936. For complete classification of this Act to the Code, see Short Title of 1996
Amendments note set out under section 201 of this title
and Tables.
AMENDMENTS
2010—Subsec. (a)(1)(A). Pub. L. 111–148, § 10402(a), inserted ‘‘and vision’’ after ‘‘oral’’.

PART R—PROGRAMS RELATING TO AUTISM
§ 280i. Developmental disabilities surveillance
and research program
(a) Autism spectrum disorder and other developmental disabilities
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may award grants or cooperative agreements to eligible entities for the collection,
analysis, and reporting of State epidemiological data on autism spectrum disorder and
other developmental disabilities. An eligible
entity shall assist with the development and
coordination of State autism spectrum disorder and other developmental disability surveillance efforts within a region. In making
such awards, the Secretary may provide direct
technical assistance in lieu of cash.
(2) Data standards
In submitting epidemiological data to the
Secretary pursuant to paragraph (1), an eligi-

§ 280i–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ble entity shall report data according to
guidelines prescribed by the Director of the
Centers for Disease Control and Prevention,
after consultation with relevant State and
local public health officials, private sector developmental disability researchers, and advocates for individuals with autism spectrum
disorder or other developmental disabilities.
(3) Eligibility
To be eligible to receive an award under
paragraph (1), an entity shall be a public or
nonprofit private entity (including a health
department of a State or a political subdivision of a State, a university, or any other educational institution), and submit to the Secretary an application at such time, in such
manner, and containing such information as
the Secretary may require.
(b) Centers of excellence in autism spectrum disorder epidemiology
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall, subject to the availability of appropriations, award grants or cooperative
agreements for the establishment of regional
centers of excellence in autism spectrum disorder and other developmental disabilities epidemiology for the purpose of collecting and
analyzing information on the number, incidence, correlates, and causes of autism spectrum disorder and other developmental disabilities.
(2) Requirements
To be eligible to receive a grant or cooperative agreement under paragraph (1), an entity
shall submit to the Secretary an application
containing such agreements and information
as the Secretary may require, including an
agreement that the center to be established
under the grant or cooperative agreement
shall operate in accordance with the following:
(A) The center will collect, analyze, and
report autism spectrum disorder and other
developmental disability data according to
guidelines prescribed by the Director of the
Centers for Disease Control and Prevention,
after consultation with relevant State and
local public health officials, private sector
developmental disability researchers, and
advocates for individuals with developmental disabilities.
(B) The center will develop or extend an
area of special research expertise (including
genetics, epigenetics, and epidemiological
research related to environmental exposures), immunology, and other relevant research specialty areas.
(C) The center will identify eligible cases
and controls through its surveillance system
and conduct research into factors which may
cause or increase the risk of autism spectrum disorder and other developmental disabilities.
(c) Federal response
The Secretary shall coordinate the Federal response to requests for assistance from State
health, mental health, and education depart-

Page 472

ment officials regarding potential or alleged autism spectrum disorder or developmental disability clusters.
(d) Definitions
In this part:
(1) Other developmental disabilities
The term ‘‘other developmental disabilities’’
has the meaning given the term ‘‘developmental disability’’ in section 15002(8) of this
title.
(2) State
The term ‘‘State’’ means each of the several
States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa,
Guam, the Commonwealth of the Northern
Mariana Islands, the Virgin Islands, and the
Trust Territory of the Pacific Islands.
(e) Sunset
This section shall not apply after September
30, 2011.
(July 1, 1944, ch. 373, title III, § 399AA, as added
Pub. L. 109–416, § 3(a), Dec. 19, 2006, 120 Stat.
2822.)
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.

§ 280i–1. Autism education, early detection, and
intervention
(a) Purpose
It is the purpose of this section—
(1) to increase awareness, reduce barriers to
screening and diagnosis, promote evidencebased interventions for individuals with autism spectrum disorder or other developmental disabilities, and train professionals to
utilize valid and reliable screening tools to diagnose or rule out and provide evidence-based
interventions for children with autism spectrum disorder and other developmental disabilities; and
(2) to conduct activities under this section
with a focus on an interdisciplinary approach
(as defined in programs developed under section 501(a)(2) of the Social Security Act [42
U.S.C. 701(a)(2)]) that will also focus on specific issues for children who are not receiving
an early diagnosis and subsequent interventions.
(b) In general
The Secretary shall, subject to the availability of appropriations, establish and evaluate activities to—
(1) provide information and education on autism spectrum disorder and other developmental disabilities to increase public awareness of developmental milestones;
(2) promote research into the development
and validation of reliable screening tools for
autism spectrum disorder and other developmental disabilities and disseminate information regarding those screening tools;
(3) promote early screening of individuals at
higher risk for autism spectrum disorder and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

other developmental disabilities as early as
practicable, given evidence-based screening
techniques and interventions;
(4) increase the number of individuals who
are able to confirm or rule out a diagnosis of
autism spectrum disorder and other developmental disabilities;
(5) increase the number of individuals able
to provide evidence-based interventions for individuals diagnosed with autism spectrum disorder or other developmental disabilities; and
(6) promote the use of evidence-based interventions for individuals at higher risk for autism spectrum disorder and other developmental disabilities as early as practicable.
(c) Information and education
(1) In general
In carrying out subsection (b)(1), the Secretary, in collaboration with the Secretary of
Education and the Secretary of Agriculture,
shall, subject to the availability of appropriations, provide culturally competent information regarding autism spectrum disorder and
other developmental disabilities, risk factors,
characteristics, identification, diagnosis or
rule out, and evidence-based interventions to
meet the needs of individuals with autism
spectrum disorder or other developmental disabilities and their families through—
(A) Federal programs, including—
(i) the Head Start program;
(ii) the Early Start program;
(iii) the Healthy Start program;
(iv) programs under the Child Care and
Development Block Grant Act of 1990 [42
U.S.C. 9858 et seq.];
(v) programs under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]
(particularly the Medicaid Early and Periodic Screening, Diagnosis and Treatment
Program);
(vi) the program under title XXI of the
Social Security Act [42 U.S.C. 1397aa et
seq.] (the State Children’s Health Insurance Program);
(vii) the program under title V of the Social Security Act [42 U.S.C. 701 et seq.] (the
Maternal and Child Health Block Grant
Program);
(viii) the program under parts B and C of
the Individuals with Disabilities Education Act [20 U.S.C. 1411 et seq., 1431 et
seq.];
(ix) the special supplemental nutrition
program for women, infants, and children
established under section 1786 of this title;
and
(x) the State grant program under the
Rehabilitation Act of 1973 [29 U.S.C. 701 et
seq.].
(B) State licensed child care facilities; and
(C) other community-based organizations
or points of entry for individuals with autism spectrum disorder and other developmental disabilities to receive services.
(2) Lead agency
(A) Designation
As a condition on the provision of assistance or the conduct of activities under this

§ 280i–1

section with respect to a State, the Secretary may require the Governor of the
State—
(i) to designate a public agency as a lead
agency to coordinate the activities provided for under paragraph (1) in the State
at the State level; and
(ii) acting through such lead agency, to
make available to individuals and their
family members, guardians, advocates, or
authorized representatives; providers; and
other appropriate individuals in the State,
comprehensive culturally competent information about State and local resources regarding autism spectrum disorder and
other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule out, available services and
supports, and evidence-based interventions.
(B) Requirements of agency
In designating the lead agency under subparagraph (A)(i), the Governor shall—
(i) select an agency that has demonstrated experience and expertise in—
(I) autism spectrum disorder and other
developmental disability issues; and
(II) developing, implementing, conducting, and administering programs and
delivering education, information, and
referral services (including technologybased curriculum-development services)
to individuals with developmental disabilities and their family members,
guardians, advocates or authorized representatives, providers, and other appropriate individuals locally and across the
State; and
(ii) consider input from individuals with
developmental disabilities and their family members, guardians, advocates or authorized representatives, providers, and
other appropriate individuals.
(C) Information
Information under subparagraph (A)(ii)
shall be provided through—
(i) toll-free telephone numbers;
(ii) Internet websites;
(iii) mailings; or
(iv) such other means as the Governor
may require.
(d) Tools
(1) In general
To promote the use of valid and reliable
screening tools for autism spectrum disorder
and other developmental disabilities, the Secretary shall develop a curriculum for continuing education to assist individuals in recognizing the need for valid and reliable screening
tools and the use of such tools.
(2) Collection, storage, coordination, and availability
The Secretary, in collaboration with the
Secretary of Education, shall provide for the
collection, storage, coordination, and public
availability of tools described in paragraph (1),
educational materials and other products that
are used by the Federal programs referred to
in subsection (c)(1)(A), as well as—

§ 280i–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) programs authorized under the Developmental Disabilities Assistance and Bill of
Rights Act of 2000 [42 U.S.C. 15001 et seq.];
(B) early intervention programs or interagency coordinating councils authorized
under part C of the Individuals with Disabilities Education Act [20 U.S.C. 1431 et seq.];
and
(C) children with special health care needs
programs authorized under title V of the Social Security Act [42 U.S.C. 701 et seq.].
(3) Required sharing
In establishing mechanisms and entities
under this subsection, the Secretary, and the
Secretary of Education, shall ensure the sharing of tools, materials, and products developed
under this subsection among entities receiving
funding under this section.
(e) Diagnosis
(1) Training
The Secretary, in coordination with activities conducted under title V of the Social Security Act [42 U.S.C. 701 et seq.], shall, subject
to the availability of appropriations, expand
existing interdisciplinary training opportunities or opportunities to increase the number of
sites able to diagnose or rule out individuals
with autism spectrum disorder or other developmental disabilities and ensure that—
(A) competitive grants or cooperative
agreements are awarded to public or nonprofit agencies, including institutions of
higher education, to expand existing or develop new maternal and child health interdisciplinary
leadership
education
in
neurodevelopmental and related disabilities
programs (similar to the programs developed
under section 501(a)(2) of the Social Security
Act [42 U.S.C. 701(a)(2)]) in States that do
not have such a program;
(B) trainees under such training programs—
(i) receive an appropriate balance of academic, clinical, and community opportunities;
(ii) are culturally competent;
(iii) are ethnically diverse;
(iv) demonstrate a capacity to evaluate,
diagnose or rule out, develop, and provide
evidence-based interventions to individuals with autism spectrum disorder and
other developmental disabilities; and
(v) demonstrate an ability to use a family-centered approach; and
(C) program sites provide culturally competent services.
(2) Technical assistance
The Secretary may award one or more
grants under this section to provide technical
assistance to the network of interdisciplinary
training programs.
(3) Best practices
The Secretary shall promote research into
additional valid and reliable tools for shortening the time required to confirm or rule out a
diagnosis of autism spectrum disorder or other
developmental disabilities and detecting individuals with autism spectrum disorder or

Page 474

other developmental disabilities at an earlier
age.
(f) Intervention
The Secretary shall promote research,
through grants or contracts, to determine the
evidence-based practices for interventions for
individuals with autism spectrum disorder or
other developmental disabilities, develop guidelines for those interventions, and disseminate
information related to such research and guidelines.
(g) Sunset
This section shall not apply after September
30, 2011.
(July 1, 1944, ch. 373, title III, § 399BB, as added
Pub. L. 109–416, § 3(a), Dec. 19, 2006, 120 Stat.
2823.)
REFERENCES IN TEXT
The Child Care and Development Block Grant Act of
1990, referred to in subsec. (c)(1)(A)(iv), is subchapter C
(§ 658A et seq.) of chapter 8 of subtitle A of title VI of
Pub. L. 97–35, as added by Pub. L. 101–508, title V,
§ 5082(2), Nov. 5, 1990, 104 Stat. 1388–236, as amended,
which is classified generally to subchapter II–B (§ 9858
et seq.) of chapter 105 of this title. For complete classification of this Act to the Code, see Short Title note
set out under section 9801 of this title and Tables.
The Social Security Act, referred to in subsecs.
(c)(1)(A)(v)–(vii), (d)(2)(C), and (e)(1), is act Aug. 14, 1935,
ch. 531, 49 Stat. 620, as amended. Titles V, XIX, and XXI
of the Act are classified generally to subchapters V
(§ 701 et seq.), XIX (§ 1396 et seq.), and XXI (§ 1397aa et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.
The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1)(A)(viii) and (d)(2)(B), is title
VI of Pub. L. 91–230, Apr. 13, 1970, 84 Stat. 175, as amended. Parts B and C of the Act are classified generally to
subchapters II (§ 1411 et seq.) and III (§ 1431 et seq.), respectively, of chapter 33 of Title 20, Education. For
complete classification of this Act to the Code, see section 1400 of Title 20 and Tables.
The Rehabilitation Act of 1973, referred to in subsec.
(c)(1)(A)(x), is Pub. L. 93–112, Sept. 26, 1973, 87 Stat. 355,
as amended, which is classified principally to chapter
16 (§ 701 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see Short Title note
set out under section 701 of Title 29 and Tables.
The Developmental Disabilities Assistance and Bill of
Rights Act of 2000, referred to in subsec. (d)(2)(A), is
Pub. L. 106–402, Oct. 30, 2000, 114 Stat. 1677, which is
classified principally to chapter 144 (§ 15001 et seq.) of
this title. For complete classification of this Act to the
Code, see Short Title note set out under section 15001
of this title and Tables.

§ 280i–2. Interagency Autism Coordinating Committee
(a) Establishment
The Secretary shall establish a committee, to
be known as the ‘‘Interagency Autism Coordinating Committee’’ (in this section referred to
as the ‘‘Committee’’), to coordinate all efforts
within the Department of Health and Human
Services concerning autism spectrum disorder.
(b) Responsibilities
In carrying out its duties under this section,
the Committee shall—
(1) develop and annually update a summary
of advances in autism spectrum disorder re-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

search related to causes, prevention, treatment, early screening, diagnosis or rule out,
intervention, and access to services and supports for individuals with autism spectrum
disorder;
(2) monitor Federal activities with respect
to autism spectrum disorder;
(3) make recommendations to the Secretary
regarding any appropriate changes to such activities, including recommendations to the Director of NIH with respect to the strategic
plan developed under paragraph (5);
(4) make recommendations to the Secretary
regarding public participation in decisions relating to autism spectrum disorder;
(5) develop and annually update a strategic
plan for the conduct of, and support for, autism spectrum disorder research, including
proposed budgetary requirements; and
(6) submit to the Congress such strategic
plan and any updates to such plan.
(c) Membership
(1) In general
The Committee shall be composed of—
(A) the Director of the Centers for Disease
Control and Prevention;
(B) the Director of the National Institutes
of Health, and the Directors of such national
research institutes of the National Institutes of Health as the Secretary determines
appropriate;
(C) the heads of such other agencies as the
Secretary determines appropriate;
(D) representatives of other Federal Governmental agencies that serve individuals
with autism spectrum disorder such as the
Department of Education; and
(E) the additional members appointed
under paragraph (2).
(2) Additional members
Not fewer than 6 members of the Committee,
or 1/3 of the total membership of the Committee, whichever is greater, shall be composed of
non-Federal public members to be appointed
by the Secretary, of which—
(A) at least one such member shall be an
individual with a diagnosis of autism spectrum disorder;
(B) at least one such member shall be a
parent or legal guardian of an individual
with an autism spectrum disorder; and
(C) at least one such member shall be a
representative of leading research, advocacy,
and service organizations for individuals
with autism spectrum disorder.
(d) Administrative support; terms of service;
other provisions
The following provisions shall apply with respect to the Committee:
(1) The Committee shall receive necessary
and appropriate administrative support from
the Secretary.
(2) Members of the Committee appointed
under subsection (c)(2) shall serve for a term
of 4 years, and may be reappointed for one or
more additional 4 year term. Any member appointed to fill a vacancy for an unexpired term
shall be appointed for the remainder of such
term. A member may serve after the expira-

§ 280i–3

tion of the member’s term until a successor
has taken office.
(3) The Committee shall meet at the call of
the chairperson or upon the request of the Secretary. The Committee shall meet not fewer
than 2 times each year.
(4) All meetings of the Committee shall be
public and shall include appropriate time periods for questions and presentations by the
public.
(e) Subcommittees; establishment and membership
In carrying out its functions, the Committee
may establish subcommittees and convene
workshops and conferences. Such subcommittees shall be composed of Committee members
and may hold such meetings as are necessary to
enable the subcommittees to carry out their duties.
(f) Sunset
This section shall not apply after September
30, 2011, and the Committee shall be terminated
on such date.
(July 1, 1944, ch. 373, title III, § 399CC, as added
Pub. L. 109–416, § 3(a), Dec. 19, 2006, 120 Stat.
2827.)
§ 280i–3. Report to Congress
(a) In general
Not later than 4 years after December 19, 2006,
the Secretary, in coordination with the Secretary of Education, shall prepare and submit to
the Health, Education, Labor, and Pensions
Committee of the Senate and the Energy and
Commerce Committee of the House of Representatives a progress report on activities related to autism spectrum disorder and other developmental disabilities.
(b) Contents
The report submitted under subsection (a)
shall contain—
(1) a description of the progress made in implementing the provisions of the Combating
Autism Act of 2006;
(2) a description of the amounts expended on
the implementation of the particular provisions of Combating 1 Autism Act of 2006;
(3) information on the incidence of autism
spectrum disorder and trend data of such incidence since December 19, 2006;
(4) information on the average age of diagnosis for children with autism spectrum disorder and other disabilities, including how
that age may have changed over the 4-year period beginning on December 19, 2006;
(5) information on the average age for intervention for individuals diagnosed with autism
spectrum disorder and other developmental
disabilities, including how that age may have
changed over the 4-year period beginning on
December 19, 2006;
(6) information on the average time between
initial screening and then diagnosis or rule
out for individuals with autism spectrum disorder or other developmental disabilities, as
well as information on the average time be1 So

in original. Probably should be preceded by ‘‘the’’.

§ 280i–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tween diagnosis and evidence-based intervention for individuals with autism spectrum disorder or other developmental disabilities;
(7) information on the effectiveness and outcomes of interventions for individuals diagnosed with autism spectrum disorder, including by various subtypes, and other developmental disabilities and how the age of the
child may affect such effectiveness;
(8) information on the effectiveness and outcomes of innovative and newly developed
intervention strategies for individuals with
autism spectrum disorder or other developmental disabilities; and
(9) information on services and supports provided to individuals with autism spectrum disorder and other developmental disabilities
who have reached the age of majority (as defined for purposes of section 1415(m) of title
20).
(July 1, 1944, ch. 373, title III, § 399DD, as added
Pub. L. 109–416, § 3(a), Dec. 19, 2006, 120 Stat.
2828.)
REFERENCES IN TEXT
The Combating Autism Act of 2006, referred to in subsec. (b)(1), (2), is Pub. L. 109–416, Dec. 19, 2006, 120 Stat.
2821. For complete classification of this Act to the
Code, see Short Title of 2006 Amendment note set out
under section 201 of this title and Tables.
CODIFICATION
December 19, 2006, referred to in subsec. (b)(4), (5), was
in the original ‘‘the date of enactment of this Act’’,
which was translated as meaning the date of enactment
of Pub. L. 109–416, which enacted this section, to reflect
the probable intent of Congress.

§ 280i–4. Authorization of appropriations
(a) Developmental disabilities surveillance and
research program
To carry out section 280i of this title, there
are authorized to be appropriated the following:
(1) For fiscal year 2007, $15,000,000.
(2) For fiscal year 2008, $16,500,000.
(3) For fiscal year 2009, $18,000,000.
(4) For fiscal year 2010, $19,500,000.
(5) For fiscal year 2011, $21,000,000.
(b) Autism education, early detection, and intervention
To carry out section 280i–1 of this title, there
are authorized to be appropriated the following:
(1) For fiscal year 2007, $32,000,000.
(2) For fiscal year 2008, $37,000,000.
(3) For fiscal year 2009, $42,000,000.
(4) For fiscal year 2010, $47,000,000.
(5) For fiscal year 2011, $52,000,000.
(c) Interagency Autism Coordinating Committee;
certain other programs
To carry out section 1 280i–2, 284g, and section 2
283j of this title, there are authorized to be appropriated the following:
(1) For fiscal year 2007, $100,000,000.
(2) For fiscal year 2008, $114,500,000.
(3) For fiscal year 2009, $129,000,000.
(4) For fiscal year 2010, $143,500,000.
1 So
2 So

pear.

in original. Probably should be ‘‘sections’’.
in original. The word ‘‘section’’ probably should not ap-

Page 476

(5) For fiscal year 2011, $158,000,000.
(July 1, 1944, ch. 373, title III, § 399EE, as added
Pub. L. 109–416, § 4(a), Dec. 19, 2006, 120 Stat.
2829.)
PART S—HEALTH CARE QUALITY PROGRAMS
SUBPART I—NATIONAL STRATEGY FOR QUALITY
IMPROVEMENT IN HEALTH CARE

CODIFICATION
Subpart is based on subpart I of part S of title III of
act July 1, 1944, as added by Pub. L. 111–148, title III,
§ 3011, Mar. 23, 2010, 124 Stat. 378. No subpart II has been
enacted.

§ 280j. National strategy for quality improvement
in health care
(a) Establishment of national strategy and priorities
(1) National strategy
The Secretary, through a transparent collaborative process, shall establish a national
strategy to improve the delivery of health
care services, patient health outcomes, and
population health.
(2) Identification of priorities
(A) In general
The Secretary shall identify national priorities for improvement in developing the
strategy under paragraph (1).
(B) Requirements
The Secretary shall ensure that priorities
identified under subparagraph (A) will—
(i) have the greatest potential for improving the health outcomes, efficiency,
and patient-centeredness of health care for
all populations, including children and
vulnerable populations;
(ii) identify areas in the delivery of
health care services that have the potential for rapid improvement in the quality
and efficiency of patient care;
(iii) address gaps in quality, efficiency,
comparative
effectiveness
information
(taking into consideration the limitations
set forth in subsections (c) and (d) of section 1182 of the Social Security Act [42
U.S.C. 1320e–1(c), (d)]), and health outcomes measures and data aggregation
techniques;
(iv) improve Federal payment policy to
emphasize quality and efficiency;
(v) enhance the use of health care data
to improve quality, efficiency, transparency, and outcomes;
(vi) address the health care provided to
patients with high-cost chronic diseases;
(vii) improve research and dissemination
of strategies and best practices to improve
patient safety and reduce medical errors,
preventable admissions and readmissions,
and health care-associated infections;
(viii) reduce health disparities across
health disparity populations (as defined in
section 285t 1 of this title) and geographic
areas; and
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ix) address other areas as determined
appropriate by the Secretary.
(C) Considerations
In identifying priorities under subparagraph (A), the Secretary shall take into consideration the recommendations submitted
by the entity with a contract under section
1890(a) of the Social Security Act [42 U.S.C.
1395aaa(a)] and other stakeholders.
(D) Coordination with State agencies
The Secretary shall collaborate, coordinate, and consult with State agencies responsible for administering the Medicaid
program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] and the Children’s Health Insurance Program under title
XXI of such Act [42 U.S.C. 1397aa et seq.]
with respect to developing and disseminating strategies, goals, models, and timetables
that are consistent with the national priorities identified under subparagraph (A).
(b) Strategic plan
(1) In general
The national strategy shall include a comprehensive strategic plan to achieve the priorities described in subsection (a).
(2) Requirements
The strategic plan shall include provisions
for addressing, at a minimum, the following:
(A) Coordination among agencies within
the Department, which shall include steps to
minimize duplication of efforts and utilization of common quality measures, where
available. Such common quality measures
shall be measures identified by the Secretary under section 1139A or 1139B of the
Social Security Act [42 U.S.C. 1320b–9a,
1320b–9b] or endorsed under section 1890 of
such Act [42 U.S.C. 1395aaa].
(B) Agency-specific strategic plans to
achieve national priorities.
(C) Establishment of annual benchmarks
for each relevant agency to achieve national
priorities.
(D) A process for regular reporting by the
agencies to the Secretary on the implementation of the strategic plan.
(E) Strategies to align public and private
payers with regard to quality and patient
safety efforts.
(F) Incorporating quality improvement
and measurement in the strategic plan for
health information technology required by
the American Recovery and Reinvestment
Act of 2009 (Public Law 111–5).
(c) Periodic update of national strategy
The Secretary shall update the national strategy not less than annually. Any such update
shall include a review of short- and long-term
goals.
(d) Submission and availability of national strategy and updates
(1) Deadline for initial submission of national
strategy
Not later than January 1, 2011, the Secretary
shall submit to the relevant committees of

§ 280j

Congress the national strategy described in
subsection (a).
(2) Updates
(A) In general
The Secretary shall submit to the relevant
committees of Congress an annual update to
the strategy described in paragraph (1).
(B) Information submitted
Each update submitted under subparagraph (A) shall include—
(i) a review of the short- and long-term
goals of the national strategy and any
gaps in such strategy;
(ii) an analysis of the progress, or lack of
progress, in meeting such goals and any
barriers to such progress;
(iii) the information reported under section 1139A of the Social Security Act [42
U.S.C. 1320b–9a], consistent with the reporting requirements of such section; and
(iv) in the case of an update required to
be submitted on or after January 1, 2014,
the information reported under section
1139B(b)(4) of the Social Security Act [42
U.S.C. 1320b–9b(b)(4)], consistent with the
reporting requirements of such section.
(C) Satisfaction of other reporting requirements
Compliance with the requirements of
clauses (iii) and (iv) of subparagraph (B)
shall satisfy the reporting requirements
under sections 1139A(a)(6) and 1139B(b)(4), respectively, of the Social Security Act [42
U.S.C. 1320b–9a(a)(6), 1320b–9b(b)(4)].
(e) Health care quality Internet website
Not later than January 1, 2011, the Secretary
shall create an Internet website to make public
information regarding—
(1) the national priorities for health care
quality improvement established under subsection (a)(2);
(2) the agency-specific strategic plans for
health care quality described in subsection
(b)(2)(B); and
(3) other information, as the Secretary determines to be appropriate.
(July 1, 1944, ch. 373, title III, § 399HH, as added
and amended Pub. L. 111–148, title III, § 3011, title
X, § 10302, Mar. 23, 2010, 124 Stat. 378, 937.)
REFERENCES IN TEXT
Section 285t of this title, referred to in subsec.
(a)(2)(B)(viii), was in the original ‘‘section 485E’’, meaning section 485E of act July 1, 1944, ch. 373, as added by
section 101(a) of Pub. L. 106–525, which was classified to
section 287c–31 of this title. Section 485E of act July 1,
1944, was renumbered section 464z–3 by Pub. L. 111–148,
title X, § 10334(c)(1)(D)(i), Mar. 23, 2010, 124 Stat. 973, and
transferred to section 285t of this title. The act July 1,
1944, no longer contains a section 485E.
The Social Security Act, referred to in subsec.
(a)(2)(D), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles
XIX and XXI of the Act are classified generally to subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et seq.),
respectively, of chapter 7 of this title. For complete
classification of this Act to the Code, see section 1305
of this title and Tables.
The American Recovery and Reinvestment Act of
2009, referred to in subsec. (b)(2)(F), is Pub. L. 111–5,
Feb. 17, 2009, 123 Stat. 115. For complete classification

§ 280j–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of this Act to the Code, see Short Title of 2009 Amendment note set out under section 1 of Title 26, Internal
Revenue Code, and Tables.
AMENDMENTS
2010—Subsec. (a)(2)(B)(iii). Pub. L. 111–148, § 10302, inserted ‘‘(taking into consideration the limitations set
forth in subsections (c) and (d) of section 1182 of the Social Security Act)’’ after ‘‘information’’.
INTERAGENCY WORKING GROUP ON HEALTH CARE
QUALITY
Pub. L. 111–148, title III, § 3012, Mar. 23, 2010, 124 Stat.
380, provided that:
‘‘(a) IN GENERAL.—The President shall convene a
working group to be known as the Interagency Working
Group on Health Care Quality (referred to in this section as the ‘Working Group’).
‘‘(b) GOALS.—The goals of the Working Group shall be
to achieve the following:
‘‘(1) Collaboration, cooperation, and consultation
between Federal departments and agencies with respect to developing and disseminating strategies,
goals, models, and timetables that are consistent
with the national priorities identified under section
399HH(a)(2) of the Public Health Service Act [42
U.S.C. 280j(a)(2)] (as added by section 3011 [of Pub. L.
111–148]).
‘‘(2) Avoidance of inefficient duplication of quality
improvement efforts and resources, where practicable, and a streamlined process for quality reporting and compliance requirements.
‘‘(3) Assess alignment of quality efforts in the public sector with private sector initiatives.
‘‘(c) COMPOSITION.—
‘‘(1) IN GENERAL.—The Working Group shall be composed of senior level representatives of—
‘‘(A) the Department of Health and Human Services;
‘‘(B) the Centers for Medicare & Medicaid Services;
‘‘(C) the National Institutes of Health;
‘‘(D) the Centers for Disease Control and Prevention;
‘‘(E) the Food and Drug Administration;
‘‘(F) the Health Resources and Services Administration;
‘‘(G) the Agency for Healthcare Research and
Quality;
‘‘(H) the Office of the National Coordinator for
Health Information Technology;
‘‘(I) the Substance Abuse and Mental Health Services Administration;
‘‘(J) the Administration for Children and Families;
‘‘(K) the Department of Commerce;
‘‘(L) the Office of Management and Budget;
‘‘(M) the United States Coast Guard;
‘‘(N) the Federal Bureau of Prisons;
‘‘(O) the National Highway Traffic Safety Administration;
‘‘(P) the Federal Trade Commission;
‘‘(Q) the Social Security Administration;
‘‘(R) the Department of Labor;
‘‘(S) the United States Office of Personnel Management;
‘‘(T) the Department of Defense;
‘‘(U) the Department of Education;
‘‘(V) the Department of Veterans Affairs;
‘‘(W) the Veterans Health Administration; and
‘‘(X) any other Federal agencies and departments
with activities relating to improving health care
quality and safety, as determined by the President.
‘‘(2) CHAIR AND VICE-CHAIR.—
‘‘(A) CHAIR.—The Working Group shall be chaired
by the Secretary of Health and Human Services.
‘‘(B) VICE CHAIR.—Members of the Working Group,
other than the Secretary of Health and Human
Services, shall serve as Vice Chair of the Group on
a rotating basis, as determined by the Group.

Page 478

‘‘(d) REPORT TO CONGRESS.—Not later than December
31, 2010, and annually thereafter, the Working Group
shall submit to the relevant Committees of Congress,
and make public on an Internet website, a report describing the progress and recommendations of the
Working Group in meeting the goals described in subsection (b).’’

§ 280j–1. Collection and analysis of data for quality and resource use measures
(a) In general
(1) Establishment of strategic framework
The Secretary shall establish and implement
an overall strategic framework to carry out
the public reporting of performance information, as described in section 280j–2 of this title.
Such strategic framework may include methods and related timelines for implementing
nationally consistent data collection, data aggregation, and analysis methods.
(2) Collection and aggregation of data
The Secretary shall collect and aggregate
consistent data on quality and resource use
measures from information systems used to
support health care delivery, and may award
grants or contracts for this purpose. The Secretary shall align such collection and aggregation efforts with the requirements and assistance regarding the expansion of health information technology systems, the interoperability of such technology systems, and related standards that are in effect on March 23,
2010.
(3) Scope
The Secretary shall ensure that the data collection, data aggregation, and analysis systems described in paragraph (1) involve an increasingly broad range of patient populations,
providers, and geographic areas over time.
(b) Grants or contracts for data collection
(1) In general
The Secretary may award grants or contracts to eligible entities to support new, or
improve existing, efforts to collect and aggregate quality and resource use measures described under subsection (c).
(2) Eligible entities
To be eligible for a grant or contract under
this subsection, an entity shall—
(A) be—
(i) a multi-stakeholder entity that coordinates the development of methods and
implementation plans for the consistent
reporting of summary quality and cost information;
(ii) an entity capable of submitting such
summary data for a particular population
and providers, such as a disease registry,
regional collaboration, health plan collaboration,
or
other
population-wide
source; or
(iii) a Federal Indian Health Service program or a health program operated by an
Indian tribe (as defined in section 1603 of
title 25);
(B) promote the use of the systems that
provide data to improve and coordinate patient care;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) support the provision of timely, consistent quality and resource use information
to health care providers, and other groups
and organizations as appropriate, with an
opportunity for providers to correct inaccurate measures; and
(D) agree to report, as determined by the
Secretary, measures on quality and resource
use to the public in accordance with the public reporting process established under section 280j–2 of this title.
(c) Consistent data aggregation
The Secretary may award grants or contracts
under this section only to entities that enable
summary data that can be integrated and compared across multiple sources. The Secretary
shall provide standards for the protection of the
security and privacy of patient data.
(d) Matching funds
The Secretary may not award a grant or contract under this section to an entity unless the
entity agrees that it will make available (directly or through contributions from other public or private entities) non-Federal contributions toward the activities to be carried out
under the grant or contract in an amount equal
to $1 for each $5 of Federal funds provided under
the grant or contract. Such non-Federal matching funds may be provided directly or through
donations from public or private entities and
may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
(e) Authorization of appropriations
To carry out this section, there are authorized
to be appropriated such sums as may be necessary for fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 399II, as added
and amended Pub. L. 111–148, title III, § 3015, title
X, § 10305, Mar. 23, 2010, 124 Stat. 387, 938.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 10305, amended
subsec. (a) generally. Prior to amendment, text read as
follows: ‘‘The Secretary shall collect and aggregate
consistent data on quality and resource use measures
from information systems used to support health care
delivery to implement the public reporting of performance information, as described in section 280j–2 of this
title, and may award grants or contracts for this purpose. The Secretary shall ensure that such collection,
aggregation, and analysis systems span an increasingly
broad range of patient populations, providers, and geographic areas over time.’’

§ 280j–2. Public reporting of performance information
(a) Development of performance websites
The Secretary shall make available to the
public, through standardized Internet websites,
performance information summarizing data on
quality measures. Such information shall be tailored to respond to the differing needs of hospitals and other institutional health care providers, physicians and other clinicians, patients,
consumers, researchers, policymakers, States,
and other stakeholders, as the Secretary may
specify.
(b) Information on conditions
The performance information made publicly
available on an Internet website, as described in

§ 280j–3

subsection (a), shall include information regarding clinical conditions to the extent such information is available, and the information shall,
where appropriate, be provider-specific and sufficiently disaggregated and specific to meet the
needs of patients with different clinical conditions.
(c) Consultation
(1) In general
In carrying out this section, the Secretary
shall consult with the entity with a contract
under section 1890(a) of the Social Security
Act [42 U.S.C. 1395aaa(a)], and other entities,
as appropriate, to determine the type of information that is useful to stakeholders and the
format that best facilitates use of the reports
and of performance reporting Internet
websites.
(2) Consultation with stakeholders
The entity with a contract under section
1890(a) of the Social Security Act [42 U.S.C.
1395aaa(a)] shall convene multi-stakeholder
groups, as described in such section, to review
the design and format of each Internet website
made available under subsection (a) and shall
transmit to the Secretary the views of such
multi-stakeholder groups with respect to each
such design and format.
(d) Coordination
Where appropriate, the Secretary shall coordinate the manner in which data are presented
through Internet websites described in subsection (a) and for public reporting of other
quality measures by the Secretary, including
such quality measures under title XVIII of the
Social Security Act [42 U.S.C. 1395 et seq.].
(e) Authorization of appropriations
To carry out this section, there are authorized
to be appropriated such sums as may be necessary for fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 399JJ, as added
Pub. L. 111–148, title III, § 3015, Mar. 23, 2010, 124
Stat. 388.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (d), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XVIII of the
Act is classified generally to subchapter XVIII (§ 1395 et
seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.

§ 280j–3. Quality improvement program for hospitals with a high severity adjusted readmission rate
(a) Establishment
(1) In general
Not later than 2 years after March 23, 2010,
the Secretary shall make available a program
for eligible hospitals to improve their readmission rates through the use of patient safety
organizations (as defined in section 299b–21(4)
of this title).
(2) Eligible hospital defined
In this subsection, the term ‘‘eligible hospital’’ means a hospital that the Secretary determines has a high rate of risk adjusted re-

§ 280k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

admissions for the conditions described in section 1395ww(q)(8)(A) of this title and has not
taken appropriate steps to reduce such readmissions and improve patient safety as evidenced through historically high rates of readmissions, as determined by the Secretary.
(3) Risk adjustment
The Secretary shall utilize appropriate risk
adjustment measures to determine eligible
hospitals.
(b) Report to the Secretary
As determined appropriate by the Secretary,
eligible hospitals and patient safety organizations working with those hospitals shall report
to the Secretary on the processes employed by
the hospital to improve readmission rates and
the impact of such processes on readmission
rates.
(July 1, 1944, ch. 373, title III, § 399KK, as added
Pub. L. 111–148, title III, § 3025(b), Mar. 23, 2010,
124 Stat. 412.)
PART T—ORAL HEALTHCARE PREVENTION
ACTIVITIES
§ 280k. Oral healthcare prevention education
campaign
(a) Establishment
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention
and in consultation with professional oral
health organizations, shall, subject to the availability of appropriations, establish a 5-year national, public education campaign (referred to in
this section as the ‘‘campaign’’) that is focused
on oral healthcare prevention and education, including prevention of oral disease such as early
childhood and other caries, periodontal disease,
and oral cancer.
(b) Requirements
In establishing the campaign, the Secretary
shall—
(1) ensure that activities are targeted towards specific populations such as children,
pregnant women, parents, the elderly, individuals with disabilities, and ethnic and racial
minority populations, including Indians, Alaska Natives and Native Hawaiians (as defined
in section 1603(c) 1 of title 25) in a culturally
and linguistically appropriate manner; and
(2) utilize science-based strategies to convey
oral health prevention messages that include,
but are not limited to, community water fluoridation and dental sealants.
(c) Planning and implementation
Not later than 2 years after March 23, 2010, the
Secretary shall begin implementing the 5-year
campaign. During the 2-year period referred to
in the previous sentence, the Secretary shall
conduct planning activities with respect to the
campaign.
(July 1, 1944, ch. 373, title III, § 399LL, as added
Pub. L. 111–148, title IV, § 4102(a), Mar. 23, 2010,
124 Stat. 550.)
REFERENCES IN TEXT
Section 1603(c) of title 25, referred to in subsec. (b)(1),
which defines ‘‘Indians’’, was redesignated section
1 See

References in Text note below.

Page 480

1603(13) of title 25 by Pub. L. 111–148, title X, § 10221(a),
Mar. 23, 2010, 124 Stat. 935.

§ 280k–1. Research-based dental caries disease
management
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall award demonstration grants to eligible entities to demonstrate the effectiveness of research-based dental caries disease management
activities.
(b) Eligibility
To be eligible for a grant under this section,
an entity shall—
(1) be a community-based provider of dental
services (as defined by the Secretary), including a Federally-qualified health center, a clinic of a hospital owned or operated by a State
(or by an instrumentality or a unit of government within a State), a State or local department of health, a dental program of the Indian
Health Service, an Indian tribe or tribal organization, or an urban Indian organization (as
such terms are defined in section 1603 of title
25), a health system provider, a private provider of dental services, medical, dental, public health, nursing, nutrition educational institutions, or national organizations involved
in improving children’s oral health; and
(2) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require.
(c) Use of funds
A grantee shall use amounts received under a
grant under this section to demonstrate the effectiveness of research-based dental caries disease management activities.
(d) Use of information
The Secretary shall utilize information generated from grantees under this section in planning and implementing the public education
campaign under section 280k of this title.
(July 1, 1944, ch. 373, title III, § 399LL–1, as added
Pub. L. 111–148, title IV, § 4102(a), Mar. 23, 2010,
124 Stat. 551.)
§ 280k–2. Authorization of appropriations
There is authorized to be appropriated to
carry out this part, such sums as may be necessary.
(July 1, 1944, ch. 373, title III, § 399LL–2, as added
Pub. L. 111–148, title IV, § 4102(a), Mar. 23, 2010,
124 Stat. 551.)
§ 280k–3. Updating national oral healthcare surveillance activities
(1) PRAMS
(A) In general
The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall carry out activities to update
and improve the Pregnancy Risk Assessment
Monitoring System (referred to in this section
as ‘‘PRAMS’’) as it relates to oral healthcare.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) State reports and mandatory measurements
(i) In general
Not later than 5 years after March 23, 2010,
and every 5 years thereafter, a State shall
submit to the Secretary a report concerning
activities conducted within the State under
PRAMS.
(ii) Measurements
The oral healthcare measurements developed by the Secretary for use under PRAMS
shall be mandatory with respect to States
for purposes of the State reports under
clause (i).
(C) Funding
There is authorized to be appropriated to
carry out this paragraph, such sums as may be
necessary.
(2) National Health and Nutrition Examination
Survey
The Secretary shall develop oral healthcare
components that shall include tooth-level surveillance for inclusion in the National Health
and Nutrition Examination Survey. Such components shall be updated by the Secretary at
least every 6 years. For purposes of this paragraph, the term ‘‘tooth-level surveillance’’
means a clinical examination where an examiner looks at each dental surface, on each tooth
in the mouth and as expanded by the Division of
Oral Health of the Centers for Disease Control
and Prevention.
(3) Medical Expenditures Panel Survey
The Secretary shall ensure that the Medical
Expenditures Panel Survey by the Agency for
Healthcare Research and Quality includes the
verification of dental utilization, expenditure,
and coverage findings through conduct of a
look-back analysis.
(4) National Oral Health Surveillance System
(A) Appropriations
There is authorized to be appropriated, such
sums as may be necessary for each of fiscal
years 2010 through 2014 to increase the participation of States in the National Oral Health
Surveillance System from 16 States to all 50
States, territories, and District of Columbia.
(B) Requirements
The Secretary shall ensure that the National
Oral Health Surveillance System include the
measurement of early childhood caries.
(Pub. L. 111–148, title IV, § 4102(d), Mar. 23, 2010,
124 Stat. 552.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

PART U—EMPLOYER-BASED WELLNESS PROGRAM
§ 280l. Technical assistance for employer-based
wellness programs
In order to expand the utilization of evidencebased prevention and health promotion approaches in the workplace, the Director shall—

§ 280l

(1) provide employers (including small, medium, and large employers, as determined by
the Director) with technical assistance, consultation, tools, and other resources in evaluating
such
employers’
employer-based
wellness programs, including—
(A) measuring the participation and methods to increase participation of employees in
such programs;
(B) developing standardized measures that
assess policy, environmental and systems
changes necessary to have a positive health
impact on employees’ health behaviors,
health outcomes, and health care expenditures; and
(C) evaluating such programs as they relate to changes in the health status of employees, the absenteeism of employees, the
productivity of employees, the rate of workplace injury, and the medical costs incurred
by employees; and
(2) build evaluation capacity among workplace staff by training employers on how to
evaluate employer-based wellness programs
and ensuring evaluation resources, technical
assistance, and consultation are available to
workplace staff as needed through such mechanisms as web portals, call centers, or other
means.
(July 1, 1944, ch. 373, title III, § 399MM, as added
and amended Pub. L. 111–148, title IV, § 4303, title
X, § 10404, Mar. 23, 2010, 124 Stat. 583, 975.)
AMENDMENTS
2010—Par. (2). Pub. L. 111–148, § 10404, substituted ‘‘and
ensuring’’ for ‘‘by ensuring’’.
GRANTS FOR SMALL BUSINESSES TO PROVIDE
COMPREHENSIVE WORKPLACE WELLNESS PROGRAMS
Pub. L. 111–148, title X, § 10408, Mar. 23, 2010, 124 Stat.
977, provided that:
‘‘(a) ESTABLISHMENT.—The Secretary shall award
grants to eligible employers to provide their employees
with access to comprehensive workplace wellness programs (as described under subsection (c)).
‘‘(b) SCOPE.—
‘‘(1) DURATION.—The grant program established
under this section shall be conducted for a 5-year period.
‘‘(2) ELIGIBLE EMPLOYER.—The term ‘eligible employer’ means an employer (including a non-profit
employer) that—
‘‘(A) employs less than 100 employees who work 25
hours or greater per week; and
‘‘(B) does not provide a workplace wellness program as of the date of enactment of this Act [Mar.
23, 2010].
‘‘(c) COMPREHENSIVE WORKPLACE WELLNESS PROGRAMS.—
‘‘(1) CRITERIA.—The Secretary shall develop program criteria for comprehensive workplace wellness
programs under this section that are based on and
consistent with evidence-based research and best
practices, including research and practices as provided in the Guide to Community Preventive Services, the Guide to Clinical Preventive Services, and
the National Registry for Effective Programs.
‘‘(2) REQUIREMENTS.—A comprehensive workplace
wellness program shall be made available by an eligible employer to all employees and include the following components:
‘‘(A) Health awareness initiatives (including
health education, preventive screenings, and health
risk assessments).

§ 280l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(B) Efforts to maximize employee engagement
(including mechanisms to encourage employee participation).
‘‘(C) Initiatives to change unhealthy behaviors
and lifestyle choices (including counseling, seminars, online programs, and self-help materials).
‘‘(D) Supportive environment efforts (including
workplace policies to encourage healthy lifestyles,
healthy eating, increased physical activity, and improved mental health).
‘‘(d) APPLICATION.—An eligible employer desiring to
participate in the grant program under this section
shall submit an application to the Secretary, in such
manner and containing such information as the Secretary may require, which shall include a proposal for
a comprehensive workplace wellness program that
meet [sic] the criteria and requirements described
under subsection (c).
‘‘(e) AUTHORIZATION OF APPROPRIATION.—For purposes
of carrying out the grant program under this section,
there is authorized to be appropriated $200,000,000 for
the period of fiscal years 2011 through 2015. Amounts
appropriated pursuant to this subsection shall remain
available until expended.’’

§ 280l–1. National worksite health policies and
programs study
(a) In general
In order to assess, analyze, and monitor over
time data about workplace policies and programs, and to develop instruments to assess and
evaluate comprehensive workplace chronic disease prevention and health promotion programs,
policies and practices, not later than 2 years
after March 23, 2010, and at regular intervals (to
be determined by the Director) thereafter, the
Director shall conduct a national worksite
health policies and programs survey to assess
employer-based health policies and programs.
(b) Report
Upon the completion of each study under subsection (a), the Director shall submit to Congress a report that includes the recommendations of the Director for the implementation of
effective employer-based health policies and
programs.
(July 1, 1944, ch. 373, title III, § 399MM–1, as
added Pub. L. 111–148, title IV, § 4303, Mar. 23,
2010, 124 Stat. 583.)
§ 280l–2. Prioritization of evaluation by Secretary
The Secretary shall evaluate, in accordance
with this part, all programs funded through the
Centers for Disease Control and Prevention before conducting such an evaluation of privately
funded programs unless an entity with a privately funded wellness program requests such an
evaluation.
(July 1, 1944, ch. 373, title III, § 399MM–2, as
added Pub. L. 111–148, title IV, § 4303, Mar. 23,
2010, 124 Stat. 583.)
§ 280l–3. Prohibition of
wellness requirements

Federal

workplace

Notwithstanding any other provision of this
part, any recommendations, data, or assessments carried out under this part shall not be
used to mandate requirements for workplace
wellness programs.
(July 1, 1944, ch. 373, title III, § 399MM–3, as
added Pub. L. 111–148, title IV, § 4303, Mar. 23,
2010, 124 Stat. 583.)

Page 482

PART V—PROGRAMS RELATING TO BREAST
HEALTH AND CANCER
§ 280m. Young women’s breast health awareness
and support of young women diagnosed with
breast cancer
(a) Public education campaign
(1) In general
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall conduct a national evidence-based
education campaign to increase awareness of
young women’s knowledge regarding—
(A) breast health in young women of all racial, ethnic, and cultural backgrounds;
(B) breast awareness and good breast
health habits;
(C) the occurrence of breast cancer and the
general and specific risk factors in women
who may be at high risk for breast cancer
based on familial, racial, ethnic, and cultural backgrounds such as Ashkenazi Jewish
populations;
(D) evidence-based information that would
encourage young women and their health
care professional to increase early detection
of breast cancers; and
(E) the availability of health information
and other resources for young women diagnosed with breast cancer.
(2) Evidence-based, age appropriate messages
The campaign shall provide evidence-based,
age-appropriate messages and materials as developed by the Centers for Disease Control and
Prevention and the Advisory Committee established under paragraph (4).
(3) Media campaign
In conducting the education campaign under
paragraph (1), the Secretary shall award
grants to entities to establish national multimedia campaigns oriented to young women
that may include advertising through television, radio, print media, billboards, posters,
all forms of existing and especially emerging
social networking media, other Internet
media, and any other medium determined appropriate by the Secretary.
(4) Advisory committee
(A) Establishment
Not later than 60 days after March 23, 2010,
the Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall establish an advisory committee to assist in creating and conducting the
education campaigns under paragraph (1)
and subsection (b)(1).
(B) Membership
The Secretary, acting through the Director of the Centers for Disease Control and
Prevention, shall appoint to the advisory
committee under subparagraph (A) such
members as deemed necessary to properly
advise the Secretary, and shall include organizations and individuals with expertise in
breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling,

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treatment, rehabilitation, palliative care,
and survivorship in young women.
(b) Health care professional education campaign
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
and in consultation with the Administrator of
the Health Resources and Services Administration, shall conduct an education campaign
among physicians and other health care professionals to increase awareness—
(1) of breast health, symptoms, and early diagnosis and treatment of breast cancer in
young women, including specific risk factors
such as family history of cancer and women
that may be at high risk for breast cancer,
such as Ashkenazi Jewish population;
(2) on how to provide counseling to young
women about their breast health, including
knowledge of their family cancer history and
importance of providing regular clinical breast
examinations;
(3) concerning the importance of discussing
healthy behaviors, and increasing awareness
of services and programs available to address
overall health and wellness, and making patient referrals to address tobacco cessation,
good nutrition, and physical activity;
(4) on when to refer patients to a health care
provider with genetics expertise;
(5) on how to provide counseling that addresses long-term survivorship and health concerns of young women diagnosed with breast
cancer; and
(6) on when to provide referrals to organizations and institutions that provide credible
health information and substantive assistance
and support to young women diagnosed with
breast cancer.
(c) Prevention research activities
The Secretary, acting through—
(1) the Director of the Centers for Disease
Control and Prevention, shall conduct prevention research on breast cancer in younger
women, including—
(A) behavioral, survivorship studies, and
other research on the impact of breast cancer diagnosis on young women;
(B) formative research to assist with the
development of educational messages and information for the public, targeted populations, and their families about breast
health, breast cancer, and healthy lifestyles;
(C) testing and evaluating existing and
new social marketing strategies targeted at
young women; and
(D) surveys of health care providers and
the public regarding knowledge, attitudes,
and practices related to breast health and
breast cancer prevention and control in
high-risk populations; and
(2) the Director of the National Institutes of
Health, shall conduct research to develop and
validate new screening tests and methods for
prevention and early detection of breast cancer in young women.
(d) Support for young women diagnosed with
breast cancer
(1) In general
The Secretary shall award grants to organizations and institutions to provide health in-

§ 280m

formation from credible sources and substantive assistance directed to young women
diagnosed with breast cancer and pre-neoplastic breast diseases.
(2) Priority
In making grants under paragraph (1), the
Secretary shall give priority to applicants
that deal specifically with young women diagnosed with breast cancer and pre-neoplastic
breast disease.
(e) No duplication of effort
In conducting an education campaign or other
program under subsections (a), (b), (c), or (d),
the Secretary shall avoid duplicating other existing Federal breast cancer education efforts.
(f) Measurement; reporting
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall—
(1) measure—
(A) young women’s awareness regarding
breast health, including knowledge of family
cancer history, specific risk factors and
early warning signs, and young women’s
proactive efforts at early detection;
(B) the number or percentage of young
women utilizing information regarding lifestyle interventions that foster healthy behaviors;
(C) the number or percentage of young
women receiving regular clinical breast
exams; and
(D) the number or percentage of young
women who perform breast self exams, and
the frequency of such exams, before the implementation of this section;
(2) not less than every 3 years, measure the
impact of such activities; and
(3) submit reports to the Congress on the results of such measurements.
(g) Definition
In this section, the term ‘‘young women’’
means women 15 to 44 years of age.
(h) Authorization of appropriations
To carry out subsections (a), (b), (c)(1), and (d),
there are authorized to be appropriated $9,000,000
for each of the fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title III, § 399NN, as added
Pub. L. 111–148, title X, § 10413(b), Mar. 23, 2010,
124 Stat. 991.)
SUBCHAPTER III—NATIONAL RESEARCH
INSTITUTES
CODIFICATION
Title IV of the Public Health Service Act, comprising
this subchapter, was originally enacted by act July 1,
1944, ch. 373, 58 Stat. 707, at which time title IV related
solely to the National Cancer Institute. Because of the
extensive amendments, reorganization of the subject
matter, and expansion of title IV by the acts listed
below, title IV is shown herein as having been added by
Pub. L. 99–158, without reference to intervening amendments.
The provisions of title IV as originally enacted were
subsequently redesignated as part A of title IV and
amended, and parts B to I of title IV were added and
amended by the following acts: June 16, 1948, ch. 481, 62

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Stat. 464; June 24, 1948, ch. 621, 62 Stat. 598; Aug. 15,
1950, ch. 714, 64 Stat. 443; Oct. 5, 1961, Pub. L. 87–395, 75
Stat. 824; Oct. 17, 1962, Pub. L. 87–838, 76 Stat. 1072; Aug.
16, 1968, Pub. L. 90–489, 82 Stat. 771; Oct. 30, 1970, Pub.
L. 91–515, 84 Stat. 1297; Dec. 23, 1971, Pub. L. 92–218, 85
Stat. 778; May 19, 1972, Pub. L. 92–305, 86 Stat. 162; Sept.
19, 1972, Pub. L. 92–423, 86 Stat. 679; Apr. 22, 1974, Pub.
L. 93–270, 88 Stat. 90; May 14, 1974, Pub. L. 93–282, 88
Stat. 126; May 31, 1974, Pub. L. 93–296, 88 Stat. 184; July
12, 1974, Pub. L. 93–348, 88 Stat. 342; July 23, 1974, Pub.
L. 93–352, 88 Stat. 358; July 23, 1974, Pub. L. 93–354, 88
Stat. 373; Jan. 4, 1975, Pub. L. 93–640, 88 Stat. 2217; July
29, 1975, Pub. L. 94–63, 89 Stat. 304; Nov. 28, 1975, Pub. L.
94–135, 89 Stat. 713; Apr. 21, 1976, Pub. L. 94–273, 90 Stat.
375; Apr. 22, 1976, Pub. L. 94–278, 90 Stat. 401; Oct. 19,
1976, Pub. L. 94–562, 90 Stat. 2645; Aug. 1, 1977, Pub. L.
95–83, 91 Stat. 383; Nov. 9, 1978, Pub. L. 95–622, 92 Stat.
3412; Nov. 9, 1978, Pub. L. 95–623, 92 Stat. 3443; July 10,
1979, Pub. L. 96–32, 93 Stat. 82; Oct. 7, 1980, Pub. L.
96–398, 94 Stat. 1564; Dec. 17, 1980, Pub. L. 96–538, 94 Stat.
3183; Aug. 13, 1981, Pub. L. 97–35, 95 Stat. 358; Apr. 26,
1984, Pub. L. 98–24, 97 Stat. 175.
Title IV was subsequently amended generally and
completely reorganized by Pub. L. 99–158, § 2, Nov. 20,
1985, 99 Stat. 822.

PART A—NATIONAL INSTITUTES OF HEALTH
§ 281. Organization of National Institutes of
Health
(a) Relation to Public Health Service
The National Institutes of Health is an agency
of the Service.
(b) National research institutes and national centers
The following agencies of the National Institutes of Health are national research institutes
or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and
Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and
Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
(8) The National Institute of Dental and
Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological
Disorders and Stroke.
(11) The National Institute on Deafness and
Other Communication Disorders.
(12) The National Institute on Alcohol Abuse
and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical Sciences.
(16) The National Institute of Environmental
Health Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical
Imaging and Bioengineering.
(19) The National Human Genome Research
Institute.
(20) The National Library of Medicine.

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(21) The National Center for Research Resources.
(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(23) The National Center for Complementary
and Alternative Medicine.
(24) The National Institute on Minority
Health and Health Disparities.
(25) Any other national center that, as an
agency separate from any national research
institute, was established within the National
Institutes of Health as of the day before January 15, 2007.
(c) Division of Program Coordination, Planning,
and Strategic Initiatives
(1) In general
Within the Office of the Director of the National Institutes of Health, there shall be a Division of Program Coordination, Planning, and
Strategic Initiatives (referred to in this subsection as the ‘‘Division’’).
(2) Offices within Division
(A) Offices
The following offices are within the Division: The Office of AIDS Research, the Office
of Research on Women’s Health, the Office of
Behavioral and Social Sciences Research,
the Office of Disease Prevention, the Office
of Dietary Supplements, the Office of Rare
Diseases, and any other office located within
the Office of the Director of NIH as of the
day before January 15, 2007. In addition to
such offices, the Director of NIH may establish within the Division such additional offices or other administrative units as the Director determines to be appropriate.
(B) Authorities
Each office in the Division—
(i) shall continue to carry out the authorities that were in effect for the office
before January 15, 2007; and
(ii) shall, as determined appropriate by
the Director of NIH, support the Division
with respect to the authorities described
in section 282(b)(7) of this title.
(d) Organization
(1) Number of institutes and centers
In the National Institutes of Health, the
number of national research institutes and national centers may not exceed a total of 27, including any such institutes or centers established under authority of paragraph (2) or
under authority of this subchapter as in effect
on the day before January 15, 2007.
(2) Reorganization of institutes
(A) In general
The Secretary may establish in the National Institutes of Health one or more additional national research institutes to conduct and support research, training, health
information, and other programs with respect to any particular disease or groups of
diseases or any other aspect of human health
if—
(i) the Secretary determines that an additional institute is necessary to carry out
such activities; and

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(ii) the additional institute is not established before the expiration of 180 days
after the Secretary has provided the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate written notice of the
determination made under clause (i) with
respect to the institute.
(B) Additional authority
The Secretary may reorganize the functions of any national research institute and
may abolish any national research institute
if the Secretary determines that the institute is no longer required. A reorganization
or abolition may not take effect under this
paragraph before the expiration of 180 days
after the Secretary has provided the Committee on Energy and Commerce of the
House of Representatives and the Committee
on Health, Education, Labor, and Pensions
of the Senate written notice of the reorganization or abolition.
(3) Reorganization of Office of Director
Notwithstanding subsection (c), the Director
of NIH may, after a series of public hearings,
and with the approval of the Secretary, reorganize the offices within the Office of the Director, including the addition, removal, or
transfer of functions of such offices, and the
establishment or termination of such offices,
if the Director determines that the overall
management and operation of programs and
activities conducted or supported by such offices would be more efficiently carried out
under such a reorganization.
(4) Internal reorganization of institutes and
centers
Notwithstanding any conflicting provisions
of this subchapter, the director of a national
research institute or a national center may,
after a series of public hearings and with the
approval of the Director of NIH, reorganize the
divisions, centers, or other administrative
units within such institute or center, including the addition, removal, or transfer of functions of such units, and the establishment or
termination of such units, if the director of
such institute or center determines that the
overall management and operation of programs and activities conducted or supported
by such divisions, centers, or other units
would be more efficiently carried out under
such a reorganization.
(e) Scientific Management Review Board for
periodic organizational reviews
(1) In general
Not later than 60 days after January 15, 2007,
the Secretary shall establish an advisory
council within the National Institutes of
Health to be known as the Scientific Management Review Board (referred to in this subsection as the ‘‘Board’’).
(2) Duties
(A) Reports on organizational issues
The Board shall provide advice to the appropriate officials under subsection (d) re-

§ 281

garding the use of the authorities established in paragraphs (2), (3), and (4) of such
subsection to reorganize the National Institutes of Health (referred to in this subsection as ‘‘organizational authorities’’). Not
less frequently than once each 7 years, the
Board shall—
(i) determine whether and to what extent
the organizational authorities should be
used; and
(ii) issue a report providing the recommendations of the Board regarding the use
of the authorities and the reasons underlying the recommendations.
(B) Certain responsibilities regarding reports
The activities of the Board with respect to
a report under subparagraph (A) shall include the following:
(i) Reviewing the research portfolio of
the National Institutes of Health (referred
to in this subsection as ‘‘NIH’’) in order to
determine the progress and effectiveness
and value of the portfolio and the allocation among the portfolio activities of the
resources of NIH.
(ii) Determining pending scientific opportunities, and public health needs, with
respect to research within the jurisdiction
of NIH.
(iii) For any proposal for organizational
changes to which the Board gives significant consideration as a possible recommendation in such report—
(I) analyzing the budgetary and operational consequences of the proposed
changes;
(II) taking into account historical
funding and support for research activities at national research institutes and
centers that have been established recently relative to national research institutes and centers that have been in
existence for more than two decades;
(III) estimating the level of resources
needed to implement the proposed
changes;
(IV) assuming the proposed changes
will be made and making a recommendation for the allocation of the resources of
NIH among the national research institutes and national centers; and
(V) analyzing the consequences for the
progress of research in the areas affected
by the proposed changes.
(C) Consultation
In carrying out subparagraph (A), the
Board shall consult with—
(i) the heads of national research institutes and national centers whose directors
are not members of the Board;
(ii) other scientific leaders who are officers or employees of NIH and are not members of the Board;
(iii) advisory councils of the national research institutes and national centers;
(iv) organizations representing the scientific community; and
(v) organizations representing patients.
(3) Composition of Board
The Board shall consist of the Director of
NIH, who shall be a permanent nonvoting

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member on an ex officio basis, and an odd
number of additional members, not to exceed
21, all of whom shall be voting members. The
voting members of the Board shall be the following:
(A) Not fewer than 9 officials who are directors of national research institutes or national centers. The Secretary shall designate
such officials for membership and shall ensure that the group of officials so designated
includes directors of—
(i) national research institutes whose
budgets are substantial relative to a majority of the other institutes;
(ii) national research institutes whose
budgets are small relative to a majority of
the other institutes;
(iii) national research institutes that
have been in existence for a substantial period of time without significant organizational change under subsection (d);
(iv) as applicable, national research institutes that have undergone significant
organization changes under such subsection, or that have been established
under such subsection, other than national
research institutes for which such changes
have been in place for a substantial period
of time; and
(v) national centers.
(B) Members appointed by the Secretary
from among individuals who are not officers
or employees of the United States. Such
members shall include—
(i) individuals representing the interests
of public or private institutions of higher
education that have historically received
funds from NIH to conduct research; and
(ii) individuals representing the interests
of private entities that have received funds
from NIH to conduct research or that have
broad expertise regarding how the National Institutes of Health functions, exclusive of private entities to which clause
(i) applies.
(4) Chair
The Chair of the Board shall be selected by
the Secretary from among the members of the
Board appointed under paragraph (3)(B). The
term of office of the Chair shall be 2 years.
(5) Meetings
(A) In general
The Board shall meet at the call of the
Chair or upon the request of the Director of
NIH, but not fewer than 5 times with respect
to issuing any particular report under paragraph (2)(A). The location of the meetings of
the Board is subject to the approval of the
Director of NIH.
(B) Particular forums
Of the meetings held under subparagraph
(A) with respect to a report under paragraph
(2)(A)—
(i) one or more shall be directed toward
the scientific community to address scientific needs and opportunities related to
proposals for organizational changes under
subsection (d), or as the case may be, re-

Page 486

lated to a proposal that no such changes be
made; and
(ii) one or more shall be directed toward
consumer organizations to address the
needs and opportunities of patients and
their families with respect to proposals referred to in clause (i).
(C) Availability of information from forums
For each meeting under subparagraph (B),
the Director of NIH shall post on the Internet site of the National Institutes of Health
a summary of the proceedings.
(6) Compensation; term of office
The provisions of subsections (b)(4) and (c) of
section 284a of this title apply with respect to
the Board to the same extent and in the same
manner as such provisions apply with respect
to an advisory council referred to in such subsections, except that the reference in such
subsection (c) to 4 years regarding the term of
an appointed member is deemed to be a reference to 5 years.
(7) Reports
(A) Recommendations for changes
Each report under paragraph (2)(A) shall
be submitted to—
(i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives;
(ii) the Committee on Health, Education,
Labor, and Pensions and the Committee on
Appropriations of the Senate;
(iii) the Secretary; and
(iv) officials with organizational authorities, other than any such official who
served as a member of the Board with respect to the report involved.
(B) Availability to public
The Director of NIH shall post each report
under paragraph (2) on the Internet site of
the National Institutes of Health.
(C) Report on Board activities
Not later than 18 months after January 15,
2007, the Board shall submit to the committees specified in subparagraph (A) a report
describing the activities of the Board.
(f) Organizational changes per recommendation
of Scientific Management Review Board
(1) In general
With respect to an official who has organizational authorities within the meaning of subsection (e)(2)(A), if a recommendation to the
official for an organizational change is made
in a report under such subsection, the official
shall, except as provided in paragraphs (2), (3),
and (4) of this subsection, make the change in
accordance with the following:
(A) Not later than 100 days after the report
is submitted under subsection (e)(7)(A), the
official shall initiate the applicable public
process required in subsection (d) toward
making the change.
(B) The change shall be fully implemented
not later than the expiration of the 3-year
period beginning on the date on which such
process is initiated.

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(2) Inapplicability to certain reorganizations
Paragraph (1) does not apply to a recommendation made in a report under subsection
(e)(2)(A) if the recommendation is for—
(A) an organizational change under subsection (d)(2) that constitutes the establishment, termination, or consolidation of one
or more national research institutes or national centers; or
(B) an organizational change under subsection (d)(3).
(3) Objection by Director of NIH
(A) In general
Paragraph (1) does not apply to a recommendation for an organizational change
made in a report under subsection (e)(2)(A)
if, not later than 90 days after the report is
submitted under subsection (e)(7)(A), the Director of NIH submits to the committees
specified in such subsection a report providing that the Director objects to the change,
which report includes the reasons underlying
the objection.
(B) Scope of objection
For purposes of subparagraph (A), an objection by the Director of NIH may be made
to the entirety of a recommended organizational change or to 1 or more aspects of the
change. Any aspect of a change not objected
to by the Director in a report under subparagraph (A) shall be implemented in accordance with paragraph (1).
(4) Congressional review
An organizational change under subsection
(d)(2) that is initiated pursuant to paragraph
(1) shall be carried out by regulation in accordance with the procedures for substantive
rules under section 553 of title 5. A rule under
the preceding sentence shall be considered a
major rule for purposes of chapter 8 of such
title (relating to congressional review of agency rulemaking).
(g) Definitions
For purposes of this subchapter:
(1) The term ‘‘Director of NIH’’ means the
Director of the National Institutes of Health.
(2) The terms ‘‘national research institute’’
and ‘‘national center’’ mean an agency of the
National Institutes of Health that is—
(A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or
(B) established by the Director of NIH
under such subsection.
(h) References to NIH
For purposes of this subchapter, a reference to
the National Institutes of Health includes its
agencies.
(July 1, 1944, ch. 373, title IV, § 401, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 822; amended
Pub. L. 100–553, § 2(1), Oct. 28, 1988, 102 Stat. 2769;
Pub. L. 100–607, title I, § 101(1), Nov. 4, 1988, 102
Stat. 3048; Pub. L. 100–690, title II, § 2613(b)(2),
Nov. 18, 1988, 102 Stat. 4238; Pub. L. 102–321, title
I, § 121(a), July 10, 1992, 106 Stat. 358; Pub. L.
103–43, title XV, §§ 1501(1), 1511(b)(1), 1521(1), June
10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103–417,
§ 13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L.

§ 281

105–277, div. A, § 101(f) [title II, § 212, title VI,
§ 601(k)], Oct. 21, 1998, 112 Stat. 2681–337, 2681–359,
2681–388; Pub. L. 106–525, title I, § 101(b)(1), Nov.
22, 2000, 114 Stat. 2501; Pub. L. 106–580, § 3(e), Dec.
29, 2000, 114 Stat. 3091; Pub. L. 109–482, title I,
§§ 101(a), (b), 108(a), Jan. 15, 2007, 120 Stat. 3675,
3676, 3697; Pub. L. 110–154, § 1(b)(1), Dec. 21, 2007,
121 Stat. 1827; Pub. L. 111–148, title X,
§ 10334(c)(3)(A), Mar. 23, 2010, 124 Stat. 974.)
AMENDMENTS
2010—Subsec. (b)(24). Pub. L. 111–148 substituted ‘‘Institute’’ for ‘‘Center’’.
2007—Subsec. (b)(7). Pub. L. 110–154 substituted ‘‘Eunice Kennedy Shriver National Institute of Child
Health and Human Development’’ for ‘‘National Institute of Child Health and Human Development’’.
Pub. L. 109–482, § 101(a), reenacted section catchline
without change and amended text generally, substituting provisions consisting of subsecs. (a) to (d)(1) for
former subsecs. (a) to (d) which related to: in subsec.
(a), relationship to Public Health Service; in subsec.
(b), list of national research institutes that were agencies; in subsec. (c), establishment of additional institutes and reorganization or abolition of institutes; and,
in subsec. (d), definition of ‘‘national research institute’’. See below.
Subsec. (d)(2). Pub. L. 109–482, § 108(a), added after
subsec. (d)(1) provisions identical to text of subsec. (c)
prior to amendment by Pub. L. 109–482, § 101(a), redesignated such provisions as par. (2), added par. heading, redesignated former pars. (1) and (2) as subpars. (A) and
(B), respectively, added subpar. headings, in subpar.
(A), redesignated former subpars. (A) and (B) as cls. (i)
and (ii), respectively, in cl. (ii), substituted ‘‘Health,
Education, Labor, and Pensions’’ for ‘‘Labor and
Human Resources’’ and ‘‘clause (i)’’ for ‘‘subparagraph
(A)’’, and, in subpar. (B), substituted ‘‘Health, Education, Labor, and Pensions’’ for ‘‘Labor and Human
Resources’’.
Subsec. (d)(3), (4). Pub. L. 109–482, § 101(b)(1), added
pars. (3) and (4).
Subsecs. (e) to (h). Pub. L. 109–482, § 101(b)(2), added
subsecs. (e) to (h).
2000—Subsec. (b)(1)(R). Pub. L. 106–580 added subpar.
(R).
Subsec. (b)(2)(F). Pub. L. 106–525, § 101(b)(1)(A), realigned margins.
Subsec. (b)(2)(G). Pub. L. 106–525, § 101(b)(1)(B), added
subpar. (G).
1998—Subsec. (b)(1)(H). Pub. L. 105–277, § 101(f) [title II,
§ 212], substituted ‘‘National Institute of Dental and
Craniofacial Research’’ for ‘‘National Institute of Dental Research’’.
Subsec. (b)(2)(F). Pub. L. 105–277, § 101(f) [title VI,
§ 601(k)], added subpar. (F).
1994—Subsec. (b)(2)(E). Pub. L. 103–417 added subpar.
(E).
1993—Subsec. (b)(1)(Q). Pub. L. 103–43, § 1511(b)(1)(A),
added subpar. (Q).
Subsec. (b)(2)(B). Pub. L. 103–43, § 1501(1), amended
subpar. (B) generally, substituting ‘‘National Center for
Research Resources’’ for ‘‘Division of Research Resources’’.
Subsec. (b)(2)(D). Pub. L. 103–43, §§ 1511(b)(1)(B),
1521(1), added subpar. (D) and struck out former subpar.
(D) which read as follows: ‘‘The National Center for
Nursing Research.’’
1992—Subsec. (b)(1)(N) to (P). Pub. L. 102–321 added
subpars. (N) to (P).
1988—Subsec. (b)(1)(J), (M). Pub. L. 100–553 and Pub.
L. 100–607 made identical amendments, striking out
‘‘and Communicative’’ after ‘‘Neurological’’ in subpar.
(J), and adding subpar. (M). Pub. L. 100–690 amended
subsec. (b)(1) to read as if the amendments by Pub. L.
100–607 had not been enacted.
EFFECTIVE DATE OF 2007 AMENDMENT
Pub. L. 109–482, title I, § 109, Jan. 15, 2007, 120 Stat.
3697, provided that: ‘‘This title [see Tables for classi-

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fication] and the amendments made by this title apply
only with respect to amounts appropriated for fiscal
year 2007 or subsequent fiscal years.’’
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–525, title VI, § 603, Nov. 22, 2000, 114 Stat.
2511, provided that: ‘‘This Act [enacting subpart 6
(§ 287c–31 et seq.) of part E of this subchapter and sections 293e, 296e–1, and 299a–1 of this title, amending sections 281, 296f, 299a, 299c–6, and 300u–6 of this title, repealing section 283b of this title, and enacting provisions set out as notes under sections 201, 287c–31, 293e,
and 3501 of this title] and the amendments made by this
Act take effect October 1, 2000, or upon the date of the
enactment of this Act [Nov. 22, 2000], whichever occurs
later.’’
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.
CONSTRUCTION OF 2007 AMENDMENT
Pub. L. 109–482, title I, § 102(g), Jan. 15, 2007, 120 Stat.
3685, provided that: ‘‘This Act [see Tables for classification] and the amendments made by this Act may not be
construed as affecting the authorities of the national
research institutes and national centers that were in
effect under the Public Health Service Act [this chapter] on the day before the date of the enactment of this
Act [Jan. 15, 2007], subject to the authorities of the Secretary of Health and Human Services and the Director
of NIH under section 401 of the Public Health Service
Act [this section] (as amended by section 101 of this
Act). For purposes of the preceding sentence, the terms
‘national research institute’, ‘national center’, and ‘Director of NIH’ have the meanings given such terms in
such section 401.’’
STUDY OF THE USE OF CENTERS OF EXCELLENCE AT
THE NATIONAL INSTITUTES OF HEALTH
Pub. L. 107–84, § 7, Dec. 18, 2001, 115 Stat. 829, required
the Secretary of Health and Human Services to contract, not later than 60 days after Dec. 18, 2001, with the
Institute of Medicine to conduct a study on the impact
of, need for, and other issues associated with Centers of
Excellence at the National Institutes of Health and
complete the study and submit a report not later than
one year after the date of the contract.
REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN
DEVELOPMENT OF DEFENSES AGAINST BIOLOGICAL
WARFARE
Section 1904 of Pub. L. 103–43 directed Secretary of
Health and Human Services, in consultation with Secretary of Defense and with heads of other appropriate
executive agencies, to report to Congress, not later
than 12 months after June 10, 1993, on the appropriateness and impact of the National Institutes of Health assuming responsibility for the conduct of all Federal research, development, testing, and evaluation functions
relating to medical countermeasures against biowarfare threat agents.
RESEARCH ON LUPUS ERYTHEMATOSUS
Section 5 of Pub. L. 99–158, as amended by Pub. L.
102–531, title III, § 312(f), Oct. 27, 1992, 106 Stat. 3506, directed Secretary of Health and Human Resources to establish a Lupus Erythematosus Coordinating Committee to plan, develop, coordinate, and implement comprehensive Federal initiatives in research on Lupus

Page 488

Erythematosus, provided for composition of committee
and meetings, and directed Committee to prepare a report for Congress on its activities, to be submitted not
later than 18 months after Nov. 20, 1985, with Committee to terminate one month after the report was submitted.
INTERAGENCY COMMITTEE ON LEARNING DISABILITIES
Section 9 of Pub. L. 99–158 directed Director of the
National Institutes of Health, not later than 90 days
after Nov. 20, 1985, to establish an Interagency Committee on Learning Disabilities to review and assess Federal research priorities, activities, and findings regarding learning disabilities (including central nervous system dysfunction in children), provided for composition
of the Committee, directed Committee to report to
Congress on its activities not later than 18 months
after Nov. 20, 1985, and provided that the Committee
terminate 90 days after submission of the report.

§ 282. Director of National Institutes of Health
(a) Appointment
The National Institutes of Health shall be
headed by the Director of NIH who shall be appointed by the President by and with the advice
and consent of the Senate. The Director of NIH
shall perform functions as provided under subsection (b) of this section and as the Secretary
may otherwise prescribe.
(b) Duties and authority
In carrying out the purposes of section 241 of
this title, the Secretary, acting through the Director of NIH—
(1) shall carry out this subchapter, including
being responsible for the overall direction of
the National Institutes of Health and for the
establishment and implementation of general
policies respecting the management and operation of programs and activities within the
National Institutes of Health;
(2) shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities
within the National Institutes of Health;
(3) shall, in consultation with the heads of
the national research institutes and national
centers, be responsible for program coordination across the national research institutes
and national centers, including conducting
priority-setting reviews, to ensure that the research portfolio of the National Institutes of
Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
(4) shall assemble accurate data to be used
to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in
reducing minority and other health disparities;
(5) shall ensure that scientifically based
strategic planning is implemented in support
of research priorities as determined by the
agencies of the National Institutes of Health;
(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;
(7)(A) shall, through the Division of Program
Coordination, Planning, and Strategic Initiatives—
(i) identify research that represents important areas of emerging scientific opportuni-

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ties, rising public health challenges, or
knowledge gaps that deserve special emphasis and would benefit from conducting or
supporting additional research that involves
collaboration between 2 or more national research institutes or national centers, or
would otherwise benefit from strategic coordination and planning;
(ii) include information on such research
in reports under section 283 of this title; and
(iii) in the case of such research supported
with funds referred to in subparagraph (B)—
(I) require as appropriate that proposals
include milestones and goals for the research;
(II) require that the proposals include
timeframes for funding of the research;
and
(III) ensure appropriate consideration of
proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by
the National Institutes of Health;
(B) may, with respect to funds reserved
under section 282a(c)(1) of this title for the
Common Fund, allocate such funds to the national research institutes and national centers
for conducting and supporting research that is
identified under subparagraph (A); and
(C) may assign additional functions to the
Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;
(8) shall, in coordination with the heads of
the national research institutes and national
centers, ensure that such institutes and centers—
(A) preserve an emphasis on investigatorinitiated research project grants, including
with respect to research involving collaboration between 2 or more such institutes or
centers; and
(B) when appropriate, maximize investigator-initiated research project grants in their
annual research portfolios;
(9) shall ensure that research conducted or
supported by the National Institutes of Health
is subject to review in accordance with section
289a of this title and that, after such review,
the research is reviewed in accordance with
section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of
this title before the research proposals are approved for funding;
(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research
institutes;
(11)(A) shall oversee research training for all
of the national research institutes and National Research Service Awards in accordance
with section 288 of this title; and
(B) may conduct and support research training—
(i) for which fellowship support is not provided under section 288 of this title; and
(ii) that does not consist of residency
training of physicians or other health professionals;

§ 282

(12) may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other
matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;
(13) may, subject to appropriations Acts, collect and retain registration fees obtained from
third parties to defray expenses for scientific,
educational, and research-related conferences;
(14) for the national research institutes and
administrative entities within the National
Institutes of Health—
(A) may acquire, construct, improve, repair, operate, and maintain, at the site of
such institutes and entities, laboratories,
and other research facilities, other facilities,
equipment, and other real or personal property, and
(B) may acquire, without regard to section
8141 of title 40, by lease or otherwise through
the Administrator of General Services,
buildings or parts of buildings in the District
of Columbia or communities located adjacent to the District of Columbia for use for
a period not to exceed ten years;
(15) may secure resources for research conducted by or through the National Institutes
of Health;
(16) may, without regard to the provisions of
title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification
and General Schedule pay rates, establish such
technical and scientific peer review groups and
scientific program advisory committees as are
needed to carry out the requirements of this
subchapter and appoint and pay the members
of such groups, except that officers and employees of the United States shall not receive
additional compensation for service as members of such groups;
(17) may secure for the National Institutes of
Health consultation services and advice of persons from the United States or abroad;
(18) may use, with their consent, the services, equipment, personnel, information, and
facilities of other Federal, State, or local public agencies, with or without reimbursement
therefor;
(19) may, for purposes of study, admit and
treat at facilities of the National Institutes of
Health individuals not otherwise eligible for
such treatment;
(20) may accept voluntary and uncompensated services;
(21) may perform such other administrative
functions as the Secretary determines are
needed to effectively carry out this subchapter;
(22) may appoint physicians, dentists, and
other health care professionals, subject to the
provisions of title 5 relating to appointments
and classifications in the competitive service,
and may compensate such professionals subject to the provisions of chapter 74 of title 38;
(23) shall designate a contact point or office
to help innovators and physicians identify
sources of funding available for pediatric medical device development; and

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(24) implement the Cures Acceleration Network described in section 282d of this title.
The Federal Advisory Committee Act shall not
apply to the duration of a peer review group appointed under paragraph (16). The members of
such a group shall be individuals who by virtue
of their training or experience are eminently
qualified to perform the review functions of such
group. Not more than one-fourth of the members
of any such group shall be officers or employees
of the United States.
(c) Availability of substances and organisms for
research
The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms.
Such substances and organisms shall be made
available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(d) Services of experts or consultants; number;
payment of expenses, conditions, recovery
(1) The Director of NIH may obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than 220
experts or consultants, with scientific or other
professional qualifications, for the National Institutes of Health.
(2)(A) Except as provided in subparagraph (B),
experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for
other expenses associated with their assignment.
(B) Expenses specified in subparagraph (A)
shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the
expert or consultant has agreed in writing to
complete the entire period of the assignment or
one year of the assignment, whichever is shorter, unless separated or reassigned for reasons
which are beyond the control of the expert or
consultant and which are acceptable to the Secretary. If the expert or consultant violates the
agreement, the money spent by the United
States for such expenses is recoverable from the
expert or consultant as a debt due the United
States. The Secretary may waive in whole or in
part a right of recovery under this subparagraph.
(e) Dissemination of research information
The Director of NIH shall—
(1) advise the agencies of the National Institutes of Health on medical applications of research;
(2) coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;
(3) promote the effective transfer of the information described in paragraph (2) to the
health care community and to entities that
require such information;
(4) monitor the effectiveness of the activities
described in paragraph (3); and

Page 490

(5) ensure that, after January 1, 1994, all new
or revised health education and promotion
materials developed or funded by the National
Institutes of Health and intended for the general public are in a form that does not exceed
a level of functional literacy, as defined in the
National Literacy Act of 1991 (Public Law
102–73).
(f) Associate Director for Prevention; functions
There shall be in the National Institutes of
Health an Associate Director for Prevention.
The Director of NIH shall delegate to the Associate Director for Prevention the functions of
the Director relating to the promotion of the
disease prevention research programs of the national research institutes and the coordination
of such programs among the national research
institutes and between the national research institutes and other public and private entities,
including elementary, secondary, and post-secondary schools. The Associate Director shall—
(1) annually review the efficacy of existing
policies and techniques used by the national
research institutes to disseminate the results
of disease prevention and behavioral research
programs; and
(2) recommend, coordinate, and oversee the
modification or reconstruction of such policies
and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to
such entities.
(g) Enhancing competitiveness of certain entities
in obtaining research funds
(1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting
through the Director of the National Center for
Research Resources, shall establish a program
to enhance the competitiveness of such entities
in obtaining funds from the national research
institutes for conducting biomedical and behavioral research.
(B) The entities referred to in subparagraph
(A) are entities that conduct biomedical and behavioral research and are located in a State in
which the aggregate success rate for applications to the national research institutes for assistance for such research by the entities in the
State has historically constituted a low success
rate of obtaining such funds, relative to such aggregate rate for such entities in other States.
(C) With respect to enhancing competitiveness
for purposes of subparagraph (A), the Director of
NIH, in carrying out the program established
under such subparagraph, may—
(i) provide technical assistance to the entities involved, including technical assistance in
the preparation of applications for obtaining
funds from the national research institutes;
(ii) assist the entities in developing a plan
for biomedical or behavioral research proposals; and
(iii) assist the entities in implementing such
plan.
(2) The Director of NIH shall establish a program of supporting projects of biomedical or behavioral research whose principal researchers
are individuals who have not previously served
as the principal researchers of such projects supported by the Director.

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(h) Increased participation of women and disadvantaged individuals in biomedical and
behavioral research
The Secretary, acting through the Director of
NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting
and supporting programs for research, research
training, recruitment, and other activities, provide for an increase in the number of women and
individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the
fields of biomedical and behavioral research.
(i) Data bank of information on clinical trials for
drugs for serious or life-threatening diseases
and conditions
(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical
trials for drugs for serious or life-threatening
diseases and conditions (in this subsection referred to as the ‘‘data bank’’). The activities of
the data bank shall be integrated and coordinated with related activities of other agencies of
the Department of Health and Human Services,
and to the extent practicable, coordinated with
other data banks containing similar information.
(B) The Secretary shall establish the data
bank after consultation with the Commissioner
of Food and Drugs, the directors of the appropriate agencies of the National Institutes of
Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.
(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which
shall include toll-free telephone communications, available to individuals with serious or
life-threatening diseases and conditions, to
other members of the public, to health care providers, and to researchers.
(3) The data bank shall include the following:
(A) A registry of clinical trials (whether federally or privately funded) of experimental
treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 355(i) of title 21,
which provides a description of the purpose of
each experimental drug, either with the consent of the protocol sponsor, or when a trial to
test effectiveness begins. Information provided
shall consist of eligibility criteria for participation in the clinical trials, a description of
the location of trial sites, a point of contact
for those wanting to enroll in the trial, and a
description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children, and shall be in a form that
can be readily understood by members of the
public. Such information shall be forwarded to
the data bank by the sponsor of the trial not
later than 21 days after the approval of the
protocol.

§ 282

(B) Information pertaining to experimental
treatments for serious or life-threatening diseases and conditions that may be available—
(i) under a treatment investigational new
drug application that has been submitted to
the Secretary under section 360bbb(c) of title
21; or
(ii) as a Group C cancer drug (as defined by
the National Cancer Institute).
The data bank may also include information
pertaining to the results of clinical trials of
such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated
with the use or administration of such experimental treatments.
(4) The data bank shall not include information relating to an investigation if the sponsor
has provided a detailed certification to the Secretary that disclosure of such information would
substantially interfere with the timely enrollment of subjects in the investigation, unless the
Secretary, after the receipt of the certification,
provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.
(5) Fees collected under section 379h of title 21
shall not be used in carrying out this subsection.
(j) Expanded clinical trial registry data bank
(1) Definitions; requirement
(A) Definitions
In this subsection:
(i) Applicable clinical trial
The term ‘‘applicable clinical trial’’
means an applicable device clinical trial or
an applicable drug clinical trial.
(ii) Applicable device clinical trial
The term ‘‘applicable device clinical
trial’’ means—
(I) a prospective clinical study of
health outcomes comparing an intervention with a device subject to section
360(k), 360e, or 360j(m) of title 21 against
a control in human subjects (other than
a small clinical trial to determine the
feasibility of a device, or a clinical trial
to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and
(II) a pediatric postmarket surveillance as required under section 360l of
title 21.
(iii) Applicable drug clinical trial
(I) In general
The term ‘‘applicable drug clinical
trial’’ means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section
355 of title 21 or to section 262 of this
title.
(II) Clinical investigation
For purposes of subclause (I), the term
‘‘clinical investigation’’ has the meaning
given that term in section 312.3 of title
21, Code of Federal Regulations (or any
successor regulation).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
(III) Phase I
For purposes of subclause (I), the term
‘‘phase I’’ has the meaning given that
term in section 312.21 of title 21, Code of
Federal Regulations (or any successor
regulation).
(iv) Clinical trial information
The term ‘‘clinical trial information’’
means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under
paragraph (2) or under paragraph (3).
(v) Completion date
The term ‘‘completion date’’ means,
with respect to an applicable clinical trial,
the date that the final subject was examined or received an intervention for the
purposes of final collection of data for the
primary outcome, whether the clinical
trial
concluded
according
to
the
prespecified protocol or was terminated.
(vi) Device
The term ‘‘device’’ means a device as defined in section 321(h) of title 21.
(vii) Drug
The term ‘‘drug’’ means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of
this title.
(viii) Ongoing
The term ‘‘ongoing’’ means, with respect
to a clinical trial of a drug or a device and
to a date, that—
(I) 1 or more patients is enrolled in the
clinical trial; and
(II) the date is before the completion
date of the clinical trial.
(ix) Responsible party
The term ‘‘responsible party’’, with respect to a clinical trial of a drug or device,
means—
(I) the sponsor of the clinical trial (as
defined in section 50.3 of title 21, Code of
Federal Regulations (or any successor
regulation)); or
(II) the principal investigator of such
clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so
long as the principal investigator is responsible for conducting the trial, has
access to and control over the data from
the clinical trial, has the right to publish the results of the trial, and has the
ability to meet all of the requirements
under this subsection for the submission
of clinical trial information.

(B) Requirement
The Secretary shall develop a mechanism
by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of
submission of clinical trial information
under paragraph (2).

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(2) Expansion of clinical trial registry data
bank with respect to clinical trial information
(A) In general
(i) Expansion of data bank
To enhance patient enrollment and provide a mechanism to track subsequent
progress of clinical trials, the Secretary,
acting through the Director of NIH, shall
expand, in accordance with this subsection, the clinical trials registry of the
data bank described under subsection (i)(1)
(referred to in this subsection as the ‘‘registry data bank’’). The Director of NIH
shall ensure that the registry data bank is
made publicly available through the Internet.
(ii) Content
The clinical trial information required
to be submitted under this paragraph for
an applicable clinical trial shall include—
(I) descriptive information, including—
(aa) a brief title, intended for the lay
public;
(bb) a brief summary, intended for
the lay public;
(cc) the primary purpose;
(dd) the study design;
(ee) for an applicable drug clinical
trial, the study phase;
(ff) study type;
(gg) the primary disease or condition
being studied, or the focus of the
study;
(hh) the intervention name and
intervention type;
(ii) the study start date;
(jj) the expected completion date;
(kk) the target number of subjects;
and
(ll) outcomes, including primary and
secondary outcome measures;
(II) recruitment information, including—
(aa) eligibility criteria;
(bb) gender;
(cc) age limits;
(dd) whether the trial accepts
healthy volunteers;
(ee) overall recruitment status;
(ff) individual site status; and
(gg) in the case of an applicable drug
clinical trial, if the drug is not approved under section 355 of title 21 or
licensed under section 262 of this title,
specify whether or not there is expanded access to the drug under section 360bbb of title 21 for those who do
not qualify for enrollment in the clinical trial and how to obtain information
about such access;
(III) location and contact information,
including—
(aa) the name of the sponsor;
(bb) the responsible party, by official
title; and
(cc) the facility name and facility
contact information (including the

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
city, State, and zip code for each clinical trial location, or a toll-free number
through which such location information may be accessed); and

(IV) administrative data (which the
Secretary may make publicly available
as necessary), including—
(aa) the unique protocol identification number;
(bb) other protocol identification
numbers, if any; and
(cc) the Food and Drug Administration IND/IDE protocol number and the
record verification date.
(iii) Modifications
The Secretary may by regulation modify
the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a
modification improves and does not reduce
such clinical trial information.
(B) Format and structure
(i) Searchable categories
The Director of NIH shall ensure that
the public may, in addition to keyword
searching, search the entries in the registry data bank by 1 or more of the following criteria:
(I) The disease or condition being studied in the clinical trial, using Medical
Subject Headers (MeSH) descriptors.
(II) The name of the intervention, including any drug or device being studied
in the clinical trial.
(III) The location of the clinical trial.
(IV) The age group studied in the clinical trial, including pediatric subpopulations.
(V) The study phase of the clinical
trial.
(VI) The sponsor of the clinical trial,
which may be the National Institutes of
Health or another Federal agency, a private industry source, or a university or
other organization.
(VII) The recruitment status of the
clinical trial.
(VIII) The National Clinical Trial number or other study identification for the
clinical trial.
(ii) Additional searchable category
Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
(iii) Other elements
The Director of NIH shall also ensure
that the public may search the entries of
the registry data bank by such other elements as the Director deems necessary on
an ongoing basis.
(iv) Format
The Director of the NIH shall ensure
that the registry data bank is easily used

§ 282

by the public, and that entries are easily
compared.
(C) Data submission
The responsible party for an applicable
clinical trial, including an applicable drug
clinical trial for a serious or life-threatening
disease or condition, that is initiated after,
or is ongoing on the date that is 90 days
after, September 27, 2007, shall submit to the
Director of NIH for inclusion in the registry
data bank the clinical trial information described in of 1 subparagraph (A)(ii) not later
than the later of—
(i) 90 days after September 27, 2007;
(ii) 21 days after the first patient is enrolled in such clinical trial; or
(iii) in the case of a clinical trial that is
not for a serious or life-threatening disease or condition and that is ongoing on
September 27, 2007, 1 year after September
27, 2007.
(D) Posting of data
(i) Applicable drug clinical trial
The Director of NIH shall ensure that
clinical trial information for an applicable
drug clinical trial submitted in accordance
with this paragraph is posted in the registry data bank not later than 30 days
after such submission.
(ii) Applicable device clinical trial
The Director of NIH shall ensure that
clinical trial information for an applicable
device clinical trial submitted in accordance with this paragraph is posted publicly
in the registry data bank—
(I) not earlier than the date of clearance under section 360(k) of title 21, or
approval under section 360e or 360j(m) of
title 21, as applicable, for a device that
was not previously cleared or approved,
and not later than 30 days after such
date; or
(II) for a device that was previously
cleared or approved, not later than 30
days after the clinical trial information
under paragraph (3)(C) is required to be
posted by the Secretary.
(3) Expansion of registry data bank to include
results of clinical trials
(A) Linking registry data bank to existing results
(i) In general
Beginning not later than 90 days after
September 27, 2007, for those clinical trials
that form the primary basis of an efficacy
claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data
bank includes links to results information
as described in clause (ii) for such clinical
trial—
(I) not earlier than 30 days after the
date of the approval of the drug involved
or clearance or approval of the device involved; or
1 So

in original. The word ‘‘of’’ probably should not appear.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
(II) not later than 30 days after the results information described in clause (ii)
becomes publicly available.
(ii) Required information
(I) FDA information
The Secretary shall ensure that the
registry data bank includes links to the
following information:
(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug
Administration summary document regarding such applicable clinical trial.
(bb) If an applicable drug clinical
trial was conducted under section 355a
or 355c of title 21, a link to the posted
Food and Drug Administration assessment of the results of such trial.
(cc) Food and Drug Administration
public health advisories regarding the
drug or device that is the subject of
the applicable clinical trial, if any.
(dd) For an applicable drug clinical
trial, the Food and Drug Administration action package for approval document required under section 355(l)(2) of
title 21.
(ee) For an applicable device clinical
trial, in the case of a premarket application under section 360e of title 21,
the detailed summary of information
respecting the safety and effectiveness
of the device required under section
360j(h)(1) of title 21, or, in the case of a
report under section 360(k) of title 21,
the section 360(k) summary of the safety and effectiveness data required
under section 807.95(d) of title 21, Code
of Federal Regulations (or any successor regulation).
(II) NIH information
The Secretary shall ensure that the
registry data bank includes links to the
following information:
(aa) Medline citations to any publications focused on the results of an applicable clinical trial.
(bb) The entry for the drug that is
the subject of an applicable drug clinical trial in the National Library of
Medicine database of structured product labels, if available.
(iii) Results for existing data bank entries
The Secretary may include the links described in clause (ii) for data bank entries
for clinical trials submitted to the data
bank prior to September 27, 2007, as available.

(B) Inclusion of results
The Secretary, acting through the Director of NIH, shall—
(i) expand the registry data bank to include the results of applicable clinical
trials (referred to in this subsection as the
‘‘registry and results data bank’’);
(ii) ensure that such results are made
publicly available through the Internet;

Page 494

(iii) post publicly a glossary for the lay
public explaining technical terms related
to the results of clinical trials; and
(iv) in consultation with experts on risk
communication, provide information with
the information included under subparagraph (C) in the registry and results data
bank to help ensure that such information
does not mislead the patients or the public.
(C) Basic results
Not later than 1 year after September 27,
2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved
under section 355 of title 21 or licensed under
section 262 of this title or a device that is
cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title
21, the following elements:
(i) Demographic and baseline characteristics of patient sample
A table of the demographic and baseline
data collected overall and for each arm of
the clinical trial to describe the patients
who participated in the clinical trial, including the number of patients who
dropped out of the clinical trial and the
number of patients excluded from the
analysis, if any.
(ii) Primary and secondary outcomes
The primary and secondary outcome
measures as submitted under paragraph
(2)(A)(ii)(I)(ll), and a table of values for
each of the primary and secondary outcome measures for each arm of the clinical
trial, including the results of scientifically
appropriate tests of the statistical significance of such outcome measures.
(iii) Point of contact
A point of contact for scientific information about the clinical trial results.
(iv) Certain agreements
Whether there exists an agreement
(other than an agreement solely to comply
with applicable provisions of law protecting the privacy of participants) between
the sponsor or its agent and the principal
investigator (unless the sponsor is an employer of the principal investigator) that
restricts in any manner the ability of the
principal investigator, after the completion date of the trial, to discuss the results
of the trial at a scientific meeting or any
other public or private forum, or to publish in a scientific or academic journal information concerning the results of the
trial.
(D) Expanded registry and results data bank
(i) Expansion by rulemaking
To provide more complete results information and to enhance patient access to
and understanding of the results of clinical
trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data
bank as provided under this subparagraph.

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(ii) Clinical trials
(I) Approved products
The regulations under this subparagraph shall require the inclusion of the
results information described in clause
(iii) for—
(aa) each applicable drug clinical
trial for a drug that is approved under
section 355 of title 21 or licensed under
section 262 of this title; and
(bb) each applicable device clinical
trial for a device that is cleared under
section 360(k) of title 21 or approved
under section 360e or 360j(m) of title 21.
(II) Unapproved products
The regulations under this subparagraph shall establish whether or not the
results information described in clause
(iii) shall be required for—
(aa) an applicable drug clinical trial
for a drug that is not approved under
section 355 of title 21 and not licensed
under section 262 of this title (whether
approval or licensure was sought or
not); and
(bb) an applicable device clinical
trial for a device that is not cleared
under section 360(k) of title 21 and not
approved under section 360e or section
360j(m) of title 21 (whether clearance
or approval was sought or not).
(iii) Required elements
The regulations under this subparagraph
shall require, in addition to the elements
described in subparagraph (C), information
within each of the following categories:
(I) A summary of the clinical trial and
its results that is written in non-technical, understandable language for patients, if the Secretary determines that
such types of summary can be included
without being misleading or promotional.
(II) A summary of the clinical trial and
its results that is technical in nature, if
the Secretary determines that such
types of summary can be included without being misleading or promotional.
(III) The full protocol or such information on the protocol for the trial as may
be necessary to help to evaluate the results of the trial.
(IV) Such other categories as the Secretary determines appropriate.
(iv) Results submission
The results information described in
clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and
results data bank as provided by subparagraph (E), except that the Secretary shall
by regulation determine—
(I) whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be
increased from 1 year to a period not to
exceed 18 months;
(II) whether the clinical trial information described in clause (iii) should be re-

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quired to be submitted for an applicable
clinical trial for which the clinical trial
information described in subparagraph
(C) is submitted to the registry and results data bank before the effective date
of the regulations issued under this subparagraph; and
(III) in the case when the clinical trial
information described in clause (iii) is
required to be submitted for the applicable clinical trials described in clause
(ii)(II), the date by which such clinical
trial information shall be required to be
submitted, taking into account—
(aa) the certification process under
subparagraph (E)(iii) when approval, licensure, or clearance is sought; and
(bb) whether there should be a delay
of submission when approval, licensure, or clearance will not be sought.
(v) Additional provisions
The regulations under this subparagraph
shall also establish—
(I) a standard format for the submission of clinical trial information under
this paragraph to the registry and results data bank;
(II) additional information on clinical
trials and results that is written in nontechnical, understandable language for
patients;
(III) considering the experience under
the pilot quality control project described in paragraph (5)(C), procedures
for quality control, including using representative samples, with respect to
completeness and content of clinical
trial information under this subsection,
to help ensure that data elements are
not false or misleading and are non-promotional;
(IV) the appropriate timing and requirements for updates of clinical trial
information, and whether and, if so, how
such updates should be tracked;
(V) a statement to accompany the
entry for an applicable clinical trial
when the primary and secondary outcome measures for such clinical trial are
submitted under paragraph (4)(A) after
the date specified for the submission of
such information in paragraph (2)(C);
and
(VI) additions or modifications to the
manner of reporting of the data elements
established under subparagraph (C).
(vi) Consideration of world health organization data set
The Secretary shall consider the status
of the consensus data elements set for reporting clinical trial results of the World
Health Organization when issuing the regulations under this subparagraph.
(vii) Public meeting
The Secretary shall hold a public meeting no later than 18 months after September 27, 2007, to provide an opportunity for
input from interested parties with regard
to the regulations to be issued under this
subparagraph.

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(E) Submission of results information
(i) In general
Except as provided in clauses (iii), (iv),
(v), and (vi) the responsible party for an
applicable clinical trial that is described
in clause (ii) shall submit to the Director
of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not
later than 1 year, or such other period as
may be provided by regulation under subparagraph (D), after the earlier of—
(I) the estimated completion date of
the trial as described in paragraph
(2)(A)(ii)(I)(jj)); 2 or
(II) the actual date of completion.
(ii) Clinical trials described
An applicable clinical trial described in
this clause is an applicable clinical trial
subject to—
(I) paragraph (2)(C); and
(II)(aa) subparagraph (C); or
(bb) the regulations issued under subparagraph (D).
(iii) Delayed submission of results with certification
If the responsible party for an applicable
clinical trial submits a certification that
clause (iv) or (v) applies to such clinical
trial, the responsible party shall submit to
the Director of NIH for inclusion in the
registry and results data bank the clinical
trial information described in subparagraphs (C) and (D) as required under the
applicable clause.
(iv) Seeking initial approval of a drug or
device
With respect to an applicable clinical
trial that is completed before the drug is
initially approved under section 355 of title
21 or initially licensed under section 262 of
this title, or the device is initially cleared
under section 360(k) or initially approved
under section 360e or 360j(m) of title 21, the
responsible party shall submit to the Director of NIH for inclusion in the registry
and results data bank the clinical trial information described in subparagraphs (C)
and (D) not later than 30 days after the
drug or device is approved under such section 355, licensed under such section 262,
cleared under such section 360(k), or approved under such section 360e or 360j(m),
as applicable.
(v) Seeking approval of a new use for the
drug or device
(I) In general
With respect to an applicable clinical
trial where the manufacturer of the drug
or device is the sponsor of an applicable
clinical trial, and such manufacturer has
filed, or will file within 1 year, an application seeking approval under section
355 of title 21, licensing under section 262
2 So in original. The second closing parenthesis probably
should not appear.

Page 496

of this title, or clearance under section
360(k), or approval under section 360e or
360j(m) of title 21 for the use studied in
such clinical trial (which use is not included in the labeling of the approved
drug or device), then the responsible
party shall submit to the Director of
NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C)
and (D) on the earlier of the date that is
30 days after the date—
(aa) the new use of the drug or device
is approved under such section 355, licensed under such section 262, cleared
under such section 360(k), or approved
under such section 360e or 360j(m);
(bb) the Secretary issues a letter,
such as a complete response letter, not
approving the submission or not clearing the submission, a not approvable
letter, or a not substantially equivalent letter for the new use of the drug
or device under such section 355, 262,
360(k), 360e, or 360j(m); or
(cc) except as provided in subclause
(III), the application or premarket notification under such section 355, 262,
360(k), 360e, or 360j(m) is withdrawn
without resubmission for no less than
210 days.
(II) Requirement that each clinical trial
in application be treated the same
If a manufacturer makes a certification under clause (iii) that this clause
applies with respect to a clinical trial,
the manufacturer shall make such a certification with respect to each applicable
clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under
section 262 of this title or section 355,
360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial.
(III) Two-year limitation
The responsible party shall submit to
the Director of NIH for inclusion in the
registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years
after the date a certification under
clause (iii) was made to the Director of
NIH, if an action referred to in item (aa),
(bb), or (cc) of subclause (I) has not occurred by such date.
(vi) Extensions
The Director of NIH may provide an extension of the deadline for submission of
clinical trial information under clause (i)
if the responsible party for the trial submits to the Director a written request that
demonstrates good cause for the extension
and provides an estimate of the date on
which the information will be submitted.
The Director of NIH may grant more than
one such extension for a clinical trial.
(F) Notice to Director of NIH
The Commissioner of Food and Drugs shall
notify the Director of NIH when there is an

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action described in subparagraph (E)(iv) or
item (aa), (bb), or (cc) of subparagraph
(E)(v)(I) with respect to an application or a
report that includes a certification required
under paragraph (5)(B) of such action not
later than 30 days after such action.
(G) Posting of data
The Director of NIH shall ensure that the
clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this
paragraph is posted publicly in the registry
and results database not later than 30 days
after such submission.
(H) Waivers regarding certain clinical trial
results
The Secretary may waive any applicable
requirements of this paragraph for an applicable clinical trial, upon a written request
from the responsible party, if the Secretary
determines that extraordinary circumstances justify the waiver and that providing
the waiver is consistent with the protection
of public health, or in the interest of national security. Not later than 30 days after
any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver
and provide an explanation for why the
waiver was granted.
(I) Adverse events
(i) Regulations
Not later than 18 months after September 27, 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank
appropriate results information on serious
adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is
useful and not misleading to patients, physicians, and scientists.
(ii) Default
If the Secretary fails to issue the regulation required by clause (i) by the date that
is 24 months after September 27, 2007,
clause (iii) shall take effect.
(iii) Additional elements
Upon the application of clause (ii), the
Secretary shall include in the registry and
results data bank for applicable clinical
trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following
elements:
(I) Serious adverse events
A table of anticipated and unanticipated serious adverse events grouped by
organ system, with number and frequency of such event in each arm of the
clinical trial.
(II) Frequent adverse events
A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5

§ 282

percent within any arm of the clinical
trial, grouped by organ system, with
number and frequency of such event in
each arm of the clinical trial.
(iv) Posting of other information
In carrying out clause (iii), the Secretary shall, in consultation with experts
in risk communication, post with the
tables information to enhance patient understanding and to ensure such tables do
not mislead patients or the lay public.
(v) Relation to subparagraph (C)
Clinical trial information included in the
registry and results data bank pursuant to
this subparagraph is deemed to be clinical
trial information included in such data
bank pursuant to subparagraph (C).
(4) Additional submissions of clinical trial information
(A) Voluntary submissions
A responsible party for a clinical trial that
is not an applicable clinical trial, or that is
an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in
paragraph (2) or paragraph (3) provided the
responsible party submits clinical trial information for each applicable clinical trial
that is required to be submitted under section 262 of this title or under section 355,
360(k), 360e, or 360j(m) of title 21 in an application or report for licensure, approval, or
clearance of the drug or device for the use
studied in the clinical trial.
(B) Required submissions
(i) In general
Notwithstanding paragraphs (2) and (3)
and subparagraph (A), in any case in which
the Secretary determines for a specific
clinical trial described in clause (ii) that
posting in the registry and results data
bank of clinical trial information for such
clinical trial is necessary to protect the
public health—
(I) the Secretary may require by notification that such information be submitted to the Secretary in accordance
with paragraphs (2) and (3) except with
regard to timing of submission;
(II) unless the responsible party submits a certification under paragraph
(3)(E)(iii), such information shall be submitted not later than 30 days after the
date specified by the Secretary in the
notification; and
(III) failure to comply with the requirements under subclauses (I) and (II)
shall be treated as a violation of the corresponding requirement of such paragraphs.
(ii) Clinical trials described
A clinical trial described in this clause
is—
(I) an applicable clinical trial for a
drug that is approved under section 355
of title 21 or licensed under section 262 of
this title or for a device that is cleared

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under section 360(k) of title 21 or approved under section 360e or section
360j(m) of title 21, whose completion date
is on or after the date 10 years before
September 27, 2007; or
(II) an applicable clinical trial that is
described by both by 3 paragraph (2)(C)
and paragraph (3)(D)(ii)(II)).4
(C) Updates to clinical trial data bank
(i) Submission of updates
The responsible party for an applicable
clinical trial shall submit to the Director
of NIH for inclusion in the registry and results data bank updates to reflect changes
to the clinical trial information submitted
under paragraph (2). Such updates—
(I) shall be provided not less than once
every 12 months, unless there were no
changes to the clinical trial information
during the preceding 12-month period;
(II) shall include identification of the
dates of any such changes;
(III) not later than 30 days after the recruitment status of such clinical trial
changes, shall include an update of the
recruitment status; and
(IV) not later than 30 days after the
completion date of the clinical trial,
shall include notification to the Director
that such clinical trial is complete.
(ii) Public availability of updates
The Director of NIH shall make updates
submitted under clause (i) publicly available in the registry data bank. Except with
regard to overall recruitment status, individual site status, location, and contact
information, the Director of NIH shall ensure that updates to elements required
under subclauses (I) to (V) of paragraph
(2)(A)(ii) do not result in the removal of
any information from the original submissions or any preceding updates, and information in such databases is presented in a
manner that enables users to readily access each original element submission and
to track the changes made by the updates.
The Director of NIH shall provide a link
from the table of primary and secondary
outcomes
required
under
paragraph
(3)(C)(ii) to the tracked history required
under this clause of the primary and secondary outcome measures submitted under
paragraph (2)(A)(ii)(I)(ll).
(5) Coordination and compliance
(A) Clinical trials supported by grants from
Federal agencies
(i) Grants from certain Federal agencies
If an applicable clinical trial is funded in
whole or in part by a grant from any agency of the Department of Health and
Human Services, including the Food and
Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or
3 So

in original.
in original. The second closing parenthesis probably
should not appear.
4 So

Page 498

progress report forms required under such
grant shall include a certification that the
responsible party has made all required
submissions to the Director of NIH under
paragraphs (2) and (3).
(ii) Verification by Federal agencies
The heads of the agencies referred to in
clause (i), as applicable, shall verify that
the clinical trial information for each applicable clinical trial for which a grantee
is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant
or funding for a future grant to such
grantee.
(iii) Notice and opportunity to remedy
If the head of an agency referred to in
clause (i), as applicable, verifies that a
grantee has not submitted clinical trial information as described in clause (ii), such
agency head shall provide notice to such
grantee of such non-compliance and allow
such grantee 30 days to correct such noncompliance and submit the required clinical trial information.
(iv) Consultation with other Federal agencies
The Secretary shall—
(I) consult with other agencies that
conduct research involving human subjects in accordance with any section of
part 46 of title 45, Code of Federal Regulations (or any successor regulations), to
determine if any such research is an applicable clinical trial; and
(II) develop with such agencies procedures comparable to those described in
clauses (i), (ii), and (iii) to ensure that
clinical trial information for such applicable clinical trial is submitted under
paragraphs (2) and (3).
(B) Certification to accompany drug, biological product, and device submissions
At the time of submission of an application under section 355 of title 21, section 360e
of title 21, section 360j(m) of title 21, or section 262 of this title, or submission of a report under section 360(k) of title 21, such application or submission shall be accompanied by a certification that all applicable
requirements of this subsection have been
met. Where available, such certification
shall include the appropriate National Clinical Trial control numbers.
(C) Quality control
(i) Pilot quality control project
Until the effective date of the regulations issued under paragraph (3)(D), the
Secretary, acting through the Director of
NIH and the Commissioner of Food and
Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical
trial information submitted under paragraph (3)(C) is non-promotional and is not
false or misleading in any particular under
subparagraph (D). The Secretary shall use

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the publicly available information described in paragraph (3)(A) and any other
information available to the Secretary
about applicable clinical trials to verify
the accuracy of the clinical trial information submitted under paragraph (3)(C).
(ii) Notice of compliance
If the Secretary determines that any
clinical trial information was not submitted as required under this subsection, or
was submitted but is false or misleading in
any particular, the Secretary shall notify
the responsible party and give such party
an opportunity to remedy such noncompliance by submitting the required revised
clinical trial information not later than 30
days after such notification.
(D) Truthful clinical trial information
(i) In general
The clinical trial information submitted
by a responsible party under this subsection shall not be false or misleading in
any particular.
(ii) Effect
Clause (i) shall not have the effect of—
(I) requiring clinical trial information
with respect to an applicable clinical
trial to include information from any
source other than such clinical trial involved; or
(II) requiring clinical trial information
described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).
(E) Public notices
(i) Notice of violations
If the responsible party for an applicable
clinical trial fails to submit clinical trial
information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry
and results data bank entry for such clinical trial a notice—
(I) that the responsible party is not in
compliance with this chapter by—
(aa) failing to submit required clinical trial information; or
(bb) submitting false or misleading
clinical trial information;
(II) of the penalties imposed for the
violation, if any; and
(III) whether the responsible party has
corrected the clinical trial information
in the registry and results data bank.
(ii) Notice of failure to submit primary and
secondary outcomes
If the responsible party for an applicable
clinical trial fails to submit the primary
and secondary outcomes as required under
section 2(A)(ii)(I)(ll),5 the Director of NIH
shall include in the registry and results
data bank entry for such clinical trial a
notice that the responsible party is not in
compliance by failing to register the primary and secondary outcomes in accord5 So
in
original.
(2)(A)(ii)(I)(ll),’’.

Probably

should

be

‘‘paragraph

§ 282

ance with this chapter, and that the primary and secondary outcomes were not
publicly disclosed in the database before
conducting the clinical trial.
(iii) Failure to submit statement
The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: ‘‘The entry
for this clinical trial was not complete at
the time of submission, as required by law.
This may or may not have any bearing on
the accuracy of the information in the
entry.’’.
(iv) Submission of false information statement
The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: ‘‘The entry
for this clinical trial was found to be false
or misleading and therefore not in compliance with the law.’’.
(v) Non-submission of statement
The notice under clause (ii) for a violation described in clause (ii) shall include
the following statement: ‘‘The entry for
this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have
any bearing on the accuracy of the information in the entry.’’.
(vi) Compliance searches
The Director of NIH shall provide that
the public may easily search the registry
and results data bank for entries that include notices required under this subparagraph.
(6) Limitation on disclosure of clinical trial information
(A) In general
Nothing in this subsection (or under section 552 of title 5) shall require the Secretary to publicly disclose, by any means
other than the registry and results data
bank, information described in subparagraph
(B).
(B) Information described
Information described in this subparagraph is—
(i) information submitted to the Director of NIH under this subsection, or information of the same general nature as (or
integrally associated with) the information so submitted; and
(ii) information not otherwise publicly
available, including because it is protected
from disclosure under section 552 of title 5.
(7) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection $10,000,000 for each
fiscal year.
(k) Day care for children of employees
(1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health

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similar to those services provided by other Federal agencies (including the availability of day
care service on a 24-hour-a-day basis).
(2) Any day care provider at the National Institutes of Health shall establish a sliding scale
of fees that takes into consideration the income
and needs of the employee.
(3) For purposes regarding the provision of day
care services, the Director of NIH may enter
into rental or lease purchase agreements.
(l) Council of Councils
(1) Establishment
Not later than 90 days after January 15, 2007,
the Director of NIH shall establish within the
Office of the Director an advisory council to
be known as the ‘‘Council of Councils’’ (referred to in this subsection as the ‘‘Council’’)
for the purpose of advising the Director on
matters related to the policies and activities
of the Division of Program Coordination,
Planning, and Strategic Initiatives, including
making recommendations with respect to the
conduct and support of research described in
subsection (b)(7).
(2) Membership
(A) In general
The Council shall be composed of 27 members selected by the Director of NIH with approval from the Secretary from among the
list of nominees under subparagraph (C).
(B) Certain requirements
In selecting the members of the Council,
the Director of NIH shall ensure—
(i) the representation of a broad range of
disciplines and perspectives; and
(ii) the ongoing inclusion of at least 1
representative from each national research
institute whose budget is substantial relative to a majority of the other institutes.
(C) Nomination
The Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list
shall consist of the following:
(i) For each national research institute
and national center, 3 individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of
which—
(I) two shall be scientists; and
(II) one shall be from the general public or shall be a leader in the field of public policy, law, health policy, economics,
or management.
(ii) For each office within the Division of
Program Coordination, Planning, and
Strategic Initiatives, 1 individual nominated by the head of such office.
(iii) Members of the Council of Public
Representatives.
(3) Terms
(A) In general
The term of service for a member of the
Council shall be 6 years, except as provided
in subparagraphs (B) and (C).

Page 500

(B) Terms of initial appointees
Of the initial members selected for the
Council, the Director of NIH shall designate—
(i) nine for a term of 6 years;
(ii) nine for a term of 4 years; and
(iii) nine for a term of 2 years.
(C) Vacancies
Any member appointed to fill a vacancy
occurring before the expiration of the term
for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve
after the expiration of that member’s term
until a successor has taken office.
(July 1, 1944, ch. 373, title IV, § 402, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823; amended
Pub. L. 100–607, title I, § 111, Nov. 4, 1988, 102
Stat. 3052; Pub. L. 102–321, title I, § 163(b)(3), July
10, 1992, 106 Stat. 376; Pub. L. 103–43, title I,
§ 141(b), title II, §§ 201, 202, 206, 208, 210(b), (c),
title III, § 303(b), June 10, 1993, 107 Stat. 139, 144,
148–150, 153; Pub. L. 105–115, title I, § 113(a), Nov.
21, 1997, 111 Stat. 2310; Pub. L. 105–362, title VI,
§ 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L.
105–392, title IV, § 409, Nov. 13, 1998, 112 Stat. 3589;
Pub. L. 107–109, § 15(c)(2), Jan. 4, 2002, 115 Stat.
1420; Pub. L. 109–482, title I, §§ 102(a)–(d), (f)(1)(A),
103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684,
3687; Pub. L. 110–85, title III, § 304(a), title VIII,
§ 801(a), title XI, § 1104(2), Sept. 27, 2007, 121 Stat.
863, 904, 975; Pub. L. 110–316, title III, § 302, Aug.
14, 2008, 122 Stat. 3524; Pub. L. 111–148, title X,
§ 10409(b), Mar. 23, 2010, 124 Stat. 978.)
REFERENCES IN TEXT
The General Schedule, referred to in subsec. (b)(16), is
set out under section 5332 of Title 5, Government Organization and Employees.
The Federal Advisory Committee Act, referred to in
subsec. (b), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.
The National Literacy Act of 1991, referred to in subsec. (e)(5), is Pub. L. 102–73, July 25, 1991, 105 Stat. 333,
which was repealed by Pub. L. 105–220, title II,
§ 251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete classification of this Act to the Code, see Tables.
CODIFICATION
In subsec. (b)(14)(B), ‘‘section 8141 of title 40’’ substituted for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on
authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116
Stat. 1303, the first section of which enacted Title 40,
Public Buildings, Property, and Works.
AMENDMENTS
2010—Subsec. (b)(24). Pub. L. 111–148 added par. (24).
2008—Subsec. (j)(3)(C). Pub. L. 110–316, § 302(1), in introductory provisions, substituted ‘‘for each applicable
clinical trial for a drug that is approved under section
355 of title 21 or licensed under section 262 of this title
or a device that is cleared under section 360(k) of title
21 or approved under section 360e or 360j(m) of title 21,
the following elements:’’ for ‘‘the following elements
for drugs that are approved under section 355 of title 21
or licensed under section 262 of this title and devices
that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:’’.
Subsec. (j)(3)(I)(i), (iii). Pub. L. 110–316, § 302(2), substituted ‘‘applicable clinical trials described in subparagraph (C)’’ for ‘‘drugs described in subparagraph
(C)’’.

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2007—Subsec. (a). Pub. L. 109–482, § 102(f)(1)(A), substituted ‘‘Director of NIH who shall’’ for ‘‘Director of
the National Institutes of Health (hereafter in this subchapter referred to as the ‘Director of NIH’) who shall’’.
Subsec. (b). Pub. L. 109–482, § 102(a)(5), substituted
‘‘paragraph (16)’’ for ‘‘paragraph (6)’’ in concluding provisions.
Subsec. (b)(1). Pub. L. 109–482, § 102(a)(6), added par. (1)
and struck out former par. (1) which read as follows:
‘‘shall be responsible for the overall direction of the
National Institutes of Health and for the establishment
and implementation of general policies respecting the
management and operation of programs and activities
within the National Institutes of Health;’’.
Subsec. (b)(2), (3). Pub. L. 109–482, § 102(b), added pars.
(2) and (3) and struck out former pars. (2) and (3) which
read as follows:
‘‘(2) shall coordinate and oversee the operation of the
national research institutes and administrative entities within the National Institutes of Health;
‘‘(3) shall assure that research at or supported by the
National Institutes of Health is subject to review in accordance with section 289a of this title;’’.
Subsec. (b)(4). Pub. L. 110–85, § 1104(2), inserted ‘‘minority and other’’ after ‘‘reducing’’.
Pub. L. 109–482, § 102(b), added par. (4). Former par. (4)
redesignated (14).
Subsec. (b)(5) to (22). Pub. L. 109–482, § 102(a)(1)–(4), (b),
added pars. (5) to (13), redesignated former pars. (4) to
(11) and (14) as (14) to (22), respectively, in par. (21) inserted ‘‘and’’ at end, and struck out former pars. (12)
and (13) which read as follows:
‘‘(12) after consultation with the Director of the Office of Research on Women’s Health, shall ensure that
resources of the National Institutes of Health are sufficiently allocated for projects of research on women’s
health that are identified under section 287d(b) of this
title;
‘‘(13) may conduct and support research training—
‘‘(A) for which fellowship support is not provided
under section 288 of this title; and
‘‘(B) which does not consist of residency training of
physicians or other health professionals; and’’.
Subsec. (b)(23). Pub. L. 110–85, § 304(a), added par. (23).
Subsec. (i). Pub. L. 109–482, § 102(c), redesignated subsec. (j) as (i) and struck out former subsec. (i) which related to discretionary fund for use by the Director of
NIH to carry out activities authorized in this chapter.
Subsec. (i)(5). Pub. L. 109–482, § 103(b)(1), struck out
first sentence which read as follows: ‘‘For the purpose
of carrying out this subsection, there are authorized to
be appropriated such sums as may be necessary.’’
Subsecs. (j), (k). Pub. L. 110–85, § 801(a), added subsec.
(j) and redesignated former subsec. (j) as (k). Former
subsec. (k) redesignated (l).
Pub. L. 109–482, § 102(c)(2), (d), added subsec. (k) and
redesignated former subsec. (k) as (j).
Subsec. (l). Pub. L. 110–85, § 801(a)(1), redesignated
subsec. (k) as (l).
Pub. L. 109–482, § 102(c)(1), struck out subsec. (l) which
read as follows: ‘‘The Director of NIH shall carry out
the program established in part F of subchapter X of
this chapter (relating to interagency research on trauma).’’
2002—Subsec. (j)(3)(A). Pub. L. 107–109, which directed
the amendment of the first sentence of subsec. (j)(3)(A)
by substituting ‘‘trial sites,’’ for ‘‘trial sites, and’’ and
‘‘in the trial, and a description of whether, and through
what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for
protocol exception, with appropriate safeguards, for
single-patient and expanded protocol use of the new
drug, particularly in children,’’ for ‘‘in the trial,’’, was
executed by making the substitutions in the second
sentence, to reflect the probable intent of Congress.
1998—Subsec. (b)(13), (14). Pub. L. 105–392 added pars.
(13) and (14).
Subsec. (f). Pub. L. 105–362 inserted ‘‘and’’ at end of
par. (1), substituted a period for ‘‘; and’’ at end of par.
(2), and struck out par. (3) which read as follows: ‘‘an-

§ 282

nually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—
‘‘(A) a summary of the Associate Director’s review
of existing dissemination policies and techniques together with a detailed statement concerning any
modification or restructuring, or recommendations
for modification or restructuring, of such policies and
techniques; and
‘‘(B) a detailed statement of the expenditures made
for the prevention and dissemination activities reported on and the personnel used in connection with
such activities.’’
1997—Subsecs. (j) to (l). Pub. L. 105–115 added subsec.
(j) and redesignated former subsecs. (j) and (k) as (k)
and (l), respectively.
1993—Subsec. (b)(12). Pub. L. 103–43, § 141(b), added
par. (12).
Subsec. (e)(5). Pub. L. 103–43, § 210(b), added par. (5).
Subsec. (f). Pub. L. 103–43, § 201, substituted ‘‘other
public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—’’ and pars. (1) to (3) for ‘‘other public and
private entities. The Associate Director shall annually
report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report
shall include a detailed statement of the expenditures
made for the activities reported on and the personnel
used in connection with such activities’’.
Subsec. (g). Pub. L. 103–43, § 202, added subsec. (g).
Subsec. (h). Pub. L. 103–43, § 206, added subsec. (h).
Subsec. (i). Pub. L. 103–43, § 208, added subsec. (i).
Subsec. (j). Pub. L. 103–43, § 210(c), added subsec. (j).
Subsec. (k). Pub. L. 103–43, § 303(b), added subsec. (k).
1992—Subsec. (d)(1). Pub. L. 102–321 substituted ‘‘220’’
for ‘‘two hundred’’.
1988—Subsec. (b)(6). Pub. L. 100–607 inserted ‘‘and scientific program advisory committees’’ after ‘‘peer review groups’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105–115 effective 90 days after
Nov. 21, 1997, except as otherwise provided, see section
501 of Pub. L. 105–115, set out as a note under section 321
of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
RULE OF CONSTRUCTION REGARDING CONTINUATION OF
PROGRAMS
Pub. L. 109–482, title I, § 103(c), Jan. 15, 2007, 120 Stat.
3689, provided that: ‘‘The amendment of a program by
a provision of subsection (b) [amending this section and
sections 283a, 283d, 283g to 283i, 284e to 284j, 284l, 284m,
285a–9, 285a–10, 285b–7a, 285b–7b, 285c–9, 285d–6a, 285d–8,
285e–10, 285e–10a, 285f–2, 285f–3, 285g–5, 285g–9, 285g–10,
285n, 285o, 285o–2, 285o–4, 285p, 285r, 286a–1, 287a–2, 287a–3,
287a–4, 287c–11, 287c–31 to 287c–33, 288, 288–1, and 288–5a of
this title and repealing sections 285a–8, 285b–8, 285e–11,
and 286a–2 of this title] may not be construed as terminating the authority of the Federal agency involved to
carry out the program.’’
DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC
DEVICE AVAILABILITY
Pub. L. 110–85, title III, § 305, Sept. 27, 2007, 121 Stat.
863, provided that:
‘‘(a) IN GENERAL.—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(1) REQUEST FOR PROPOSALS.—Not later than 90
days after the date of the enactment of this Act
[Sept. 27, 2007], the Secretary of Health and Human
Services shall issue a request for proposals for 1 or
more grants or contracts to nonprofit consortia for
demonstration projects to promote pediatric device
development.
‘‘(2) DETERMINATION ON GRANTS OR CONTRACTS.—Not
later than 180 days after the date the Secretary of
Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make
a determination on the grants or contracts under this
section.
‘‘(b) APPLICATION.—A nonprofit consortium that desires to receive a grant or contract under this section
shall submit an application to the Secretary of Health
and Human Services at such time, in such manner, and
containing such information as the Secretary may require.
‘‘(c) USE OF FUNDS.—A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution
of pediatric medical devices by—
‘‘(1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
‘‘(2) mentoring and managing pediatric device
projects through the development process, including
product identification, prototype design, device development, and marketing;
‘‘(3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the
National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation,
the Department of Veterans Affairs, the Agency for
Healthcare Research and Quality, and the National
Institute of Standards and Technology;
‘‘(4) assessing the scientific and medical merit of
proposed pediatric device projects; and
‘‘(5) providing assistance and advice as needed on
business development, personnel training, prototype
development, postmarket needs, and other activities
consistent with the purposes of this section.
‘‘(d) COORDINATION.—
‘‘(1) NATIONAL INSTITUTES OF HEALTH.—Each consortium that receives a grant or contract under this section shall—
‘‘(A) coordinate with the National Institutes of
Health’s pediatric device contact point or office,
designated under section 402(b)(23) of the Public
Health Service Act [subsec. (b)(23) of this section],
as added by section 304(a) of this Act; and
‘‘(B) provide to the National Institutes of Health
any identified pediatric device needs that the consortium lacks sufficient capacity to address or
those needs in which the consortium has been unable to stimulate manufacturer interest.
‘‘(2) FOOD AND DRUG ADMINISTRATION.—Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food
and Drugs and device companies to facilitate the application for approval or clearance of devices labeled
for pediatric use.
‘‘(3) EFFECTIVENESS AND OUTCOMES.—Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health
and Human Services on the status of pediatric device
development, production, and distribution that has
been facilitated by the consortium.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
$6,000,000 for each of fiscal years 2008 through 2012.’’
SURVEILLANCES
Pub. L. 110–85, title VIII, § 801(c), Sept. 27, 2007, 121
Stat. 921, provided that: ‘‘Not later than 12 months
after the date of the enactment of this Act [Sept. 27,
2007], the Secretary of Health and Human Services shall

Page 502

issue guidance on how the requirements of section
402(j) of the Public Health Service Act [subsec. (j) of
this section], as added by this section, apply to a pediatric postmarket surveillance described in paragraph
(1)(A)(ii)(II) of such section 402(j) that is not a clinical
trial.’’
PREEMPTION
Pub. L. 110–85, title VIII, § 801(d), Sept. 27, 2007, 121
Stat. 922, provided that:
‘‘(1) IN GENERAL.—Upon the expansion of the registry
and results data bank under section 402(j)(3)(D) of the
Public Health Service Act [subsec. (j)(3)(D) of this section], as added by this section, no State or political
subdivision of a State may establish or continue in effect any requirement for the registration of clinical
trials or for the inclusion of information relating to the
results of clinical trials in a database.
‘‘(2) RULE OF CONSTRUCTION.—The fact of submission
of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public
Health Service Act (as amended by this section), that
relates to a use of a drug or device not included in the
official labeling of the approved drug or device shall
not be construed by the Secretary of Health and
Human Services or in any administrative or judicial
proceeding, as evidence of a new intended use of the
drug or device that is different from the intended use
of the drug or device set forth in the official labeling of
the drug or device. The availability of clinical trial information through the registry and results data bank
under such subsection (j), if submitted in compliance
with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device
under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).’’
COLLABORATION AND REPORT
Pub. L. 105–115, title I, § 113(b), Nov. 21, 1997, 111 Stat.
2312, directed the Secretary of Health and Human Services, the Director of the National Institutes of Health,
and the Commissioner of Food and Drugs to collaborate
to determine the feasibility of including device investigations within the scope of the data bank under subsec. (j) of this section, with the Secretary to report to
Congress, not later than two years after Nov. 21, 1997,
on the public health need, if any, for inclusion of device
investigations within the scope of the data bank under
subsec. (j), and on the adverse impact, if any, on device
innovation and research in the United States if information relating to such device investigations was required to be publicly disclosed.
CHRONIC FATIGUE SYNDROME; EXPERTS AND RESEARCH
REPRESENTATIVES ON ADVISORY COMMITTEES AND
BOARDS
Section 902(c) of Pub. L. 103–43 provided that: ‘‘The
Secretary of Health and Human Services, acting
through the Director of the National Institutes of
Health, shall ensure that appropriate individuals with
expertise in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of
disciplines and fields within the research community
are appointed to appropriate National Institutes of
Health advisory committees and boards.’’
THIRD-PARTY PAYMENTS REGARDING CERTAIN CLINICAL
TRIALS AND CERTAIN LIFE-THREATENING ILLNESSES
Section 1901(a) of Pub. L. 103–43 provided that: ‘‘The
Secretary of Health and Human Services, acting
through the Director of the National Institutes of
Health, shall conduct a study for the purpose of—
‘‘(1) determining the policies of third-party payors
regarding the payment of the costs of appropriate
health services that are provided incident to the participation of individuals as subjects in clinical trials
conducted in the development of drugs with respect
to acquired immune deficiency syndrome, cancer, and
other life-threatening illnesses; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) developing recommendations regarding such
policies.’’
PERSONNEL STUDY OF RECRUITMENT, RETENTION AND
TURNOVER
Section 1905 of Pub. L. 103–43 directed Secretary of
Health and Human Services, acting through Director of
National Institutes of Health, to conduct a study to review the retention, recruitment, vacancy and turnover
rates of support staff, including firefighters, law enforcement, procurement officers, technicians, nurses
and clerical employees, to ensure that National Institutes of Health is adequately supporting conduct of efficient, effective and high quality research for the
American public, and to submit a report to Congress on
results of such study not later than 1 year after June
10, 1993.
CHRONIC PAIN CONDITIONS
Section 1907 of Pub. L. 103–43 directed Director of the
National Institutes of Health to submit to Congress,
not later than 2 years after June 10, 1993, a report and
study on the incidence in the United States of cases of
chronic pain, including chronic pain resulting from
back injuries, reflex sympathetic dystrophy syndrome,
temporomandibular joint disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom pain,
and post-stroke pain, and the effect of such cases on
the costs of health care in the United States.
SUPPORT FOR BIOENGINEERING RESEARCH
Section 1912 of Pub. L. 103–43 directed Secretary of
Health and Human Services, acting through Director of
the National Institutes of Health, to conduct a study
for the purpose of determining the sources and amounts
of public and private funding devoted to basic research
in bioengineering, including biomaterials sciences, cellular bioprocessing, tissue and rehabilitation engineering, evaluating whether that commitment is sufficient
to maintain the innovative edge that the United States
has in these technologies, evaluating the role of the
National Institutes of Health or any other Federal
agency to achieve a greater commitment to innovation
in bioengineering, and evaluating the need for better
coordination and collaboration among Federal agencies
and between the public and private sectors, and, not
later than 1 year after June 10, 1993, to prepare and submit to Committee on Labor and Human Resources of
Senate, and Committee on Energy and Commerce of
House of Representatives, a report containing the findings of the study together with recommendations concerning the enactment of legislation to implement the
results of such study.
MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR
RESEARCH
Section 2002 of Pub. L. 103–43 directed Secretary of
Health and Human Services, acting through Director of
the National Institutes of Health, not later than June
1, 1994, to present to Congress a master plan to provide
for replacement or refurbishment of less than adequate
buildings, utility equipment and distribution systems
(including the resources that provide electrical and
other utilities, chilled water, air handling, and other
services that the Secretary, acting through the Director, deemed necessary), roads, walkways, parking
areas, and grounds that underpin the laboratory and
clinical facilities of the National Institutes of Health,
and provided that the plan could make recommendations for the undertaking of new projects that are consistent with the objectives of this section, such as encircling the National Institutes of Health Federal enclave with an adequate chilled water conduit.

§ 282a. Authorization of appropriations
(a) In general
For the purpose of carrying out this subchapter, there are authorized to be appropriated—

§ 282a

(1) $30,331,309,000 for fiscal year 2007;
(2) $32,831,309,000 for fiscal year 2008; and
(3) such sums as may be necessary for fiscal
year 2009.
(b) Office of the Director
Of the amount authorized to be appropriated
under subsection (a) for a fiscal year, there are
authorized to be appropriated for programs and
activities under this subchapter carried out
through the Office of the Director of NIH such
sums as may be necessary for each of the fiscal
years 2007 through 2009.
(c) Trans-NIH research
(1) Common Fund
(A) Account
For the purpose of allocations under section 282(b)(7)(B) of this title (relating to research identified by the Division of Program
Coordination, Planning, and Strategic Initiatives), there is established an account to
be known as the Common Fund.
(B) Reservation
(i) In general
Of the total amount appropriated under
subsection (a) for fiscal year 2007 or any
subsequent fiscal year, the Director of NIH
shall reserve an amount for the Common
Fund, subject to any applicable provisions
in appropriations Acts.
(ii) Minimum amount
For each fiscal year, the percentage constituted by the amount reserved under
clause (i) relative to the total amount appropriated under subsection (a) for such
year may not be less than the percentage
constituted by the amount so reserved for
the preceding fiscal year relative to the
total amount appropriated under subsection (a) for such preceding fiscal year,
subject to any applicable provisions in appropriations Acts.
(C) Common Fund strategic planning report
Not later than June 1, 2007, and every 2
years thereafter, the Secretary, acting
through the Director of NIH, shall submit a
report to the Congress containing a strategic
plan for funding research described in section 282(b)(7)(A)(i) of this title (including
personnel needs) through the Common Fund.
Each such plan shall include the following:
(i) An estimate of the amounts determined by the Director of NIH to be appropriate for maximizing the potential of
such research.
(ii) An estimate of the amounts determined by the Director of NIH to be sufficient only for continuing to fund research
activities previously identified by the Division of Program Coordination, Planning,
and Strategic Initiatives.
(iii) An estimate of the amounts determined by the Director of NIH to be necessary to fund research described in section 282(b)(7)(A)(i) of this title—
(I) that is in addition to the research
activities described in clause (ii); and
(II) for which there is the most substantial need.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) Evaluation
During the 6-month period following the
end of the first fiscal year for which the
total amount reserved under subparagraph
(B) is equal to 5 percent of the total amount
appropriated under subsection (a) for such
fiscal year, the Secretary, acting through
the Director of NIH, in consultation with the
advisory council established under section
282(k) of this title, shall submit recommendations to the Congress for changes regarding amounts for the Common Fund.
(2) Trans-NIH research reporting
(A) Limitation
With respect to the total amount appropriated under subsection (a) for fiscal year
2008 or any subsequent fiscal year, if the
head of a national research institute or national center fails to submit the report required by subparagraph (B) for the preceding
fiscal year, the amount made available for
the institute or center for the fiscal year involved may not exceed the amount made
available for the institute or center for fiscal year 2006.
(B) Reporting
Not later than January 1, 2008, and each
January 1st thereafter—
(i) the head of each national research institute or national center shall submit to
the Director of NIH a report on the
amount made available by the institute or
center for conducting or supporting research that involves collaboration between
the institute or center and 1 or more other
national research institutes or national
centers; and
(ii) the Secretary shall submit a report
to the Congress identifying the percentage
of funds made available by each national
research institute and national center
with respect to such fiscal year for conducting or supporting research described
in clause (i).
(C) Determination
For purposes of determining the amount or
percentage of funds to be reported under
subparagraph (B), any amounts made available to an institute or center under section
282(b)(7)(B) of this title shall be included.
(D) Verification of amounts
Upon receipt of each report submitted
under subparagraph (B)(i), the Director of
NIH shall review and, in cases of discrepancy, verify the accuracy of the amounts
specified in the report.
(E) Waiver
At the request of any national research institute or national center, the Director of
NIH may waive the application of this paragraph to such institute or center if the Director finds that the conduct or support of
research described in subparagraph (B)(i) is
inconsistent with the mission of such institute or center.
(d) Transfer authority
Of the total amount appropriated under subsection (a) for a fiscal year, the Director of NIH

Page 504

may (in addition to the reservation under subsection (c)(1) for such year) transfer not more
than 1 percent for programs or activities that
are authorized in this subchapter and identified
by the Director to receive funds pursuant to this
subsection. In making such transfers, the Director may not decrease any appropriation account
under subsection (a) by more than 1 percent.
(e) Rule of construction
This section may not be construed as affecting
the authorities of the Director of NIH under section 281 of this title.
(July 1, 1944, ch. 373, title IV, § 402A, as added
Pub. L. 109–482, title I, § 103(a), Jan. 15, 2007, 120
Stat. 3685.)
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 282b. Electronic coding of grants and activities
The Secretary, acting through the Director of
NIH, shall establish an electronic system to uniformly code research grants and activities of the
Office of the Director and of all the national research institutes and national centers. The electronic system shall be searchable by a variety of
codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible,
the Secretary, acting through the Director of
NIH, shall provide information on relevant literature and patents that are associated with research activities of the National Institutes of
Health.
(July 1, 1944, ch. 373, title IV, § 402B, as added
Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007,
120 Stat. 3689.)
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 282c. Public access to funded investigators’
final manuscripts
The Director of the National Institutes of
Health (‘‘NIH’’) shall require in the current fiscal year and thereafter that all investigators
funded by the NIH submit or have submitted for
them to the National Library of Medicine’s
PubMed Central an electronic version of their
final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official
date of publication: Provided, That the NIH shall
implement the public access policy in a manner
consistent with copyright law.
(Pub. L. 111–8, div. F, title II, § 217, Mar. 11, 2009,
123 Stat. 782.)
CODIFICATION
Section was enacted as part of the Department of
Health and Human Services Appropriations Act, 2009,
and also as part of the Departments of Labor, Health

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and Human Services, and Education, and Related Agencies Appropriations Act, 2009, and the Omnibus Appropriations Act, 2009, and not as part of the Public Health
Service Act which comprises this chapter.

§ 282d. Cures Acceleration Network
(a) Definitions
In this section:
(1) Biological product
The term ‘‘biological product’’ has the
meaning given such term in section 262 of this
title.
(2) Drug; device
The terms ‘‘drug’’ and ‘‘device’’ have the
meanings given such terms in section 321 of
title 21.
(3) High need cure
The term ‘‘high need cure’’ means a drug (as
that term is defined by section 321(g)(1) of title
21,1 biological product (as that term is defined
by section 262(i) 2 of this title), or device (as
that term is defined by section 321(h) of title
21) that, in the determination of the Director
of NIH—
(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and
(B) for which the incentives of the commercial market are unlikely to result in its
adequate or timely development.
(4) Medical product
The term ‘‘medical product’’ means a drug,
device, biological product, or product that is a
combination of drugs, devices, and biological
products.
(b) Establishment of the Cures Acceleration Network
Subject to the appropriation of funds as described in subsection (g), there is established
within the Office of the Director of NIH a program to be known as the Cures Acceleration
Network (referred to in this section as ‘‘CAN’’),
which shall—
(1) be under the direction of the Director of
NIH, taking into account the recommendations of a CAN Review Board (referred to in
this section as the ‘‘Board’’), described in subsection (d); and
(2) award grants and contracts to eligible entities, as described in subsection (e), to accelerate the development of high need cures, including through the development of medical
products and behavioral therapies.
(c) Functions
The functions of the CAN are to—
(1) conduct and support revolutionary advances in basic research, translating scientific
discoveries from bench to bedside;
(2) award grants and contracts to eligible entities to accelerate the development of high
need cures;
(3) provide the resources necessary for government agencies, independent investigators,
1 So in original. A closing parenthesis probably should precede
the comma.
2 See References in Text note below.

§ 282d

research organizations, biotechnology companies, academic research institutions, and
other entities to develop high need cures;
(4) reduce the barriers between laboratory
discoveries and clinical trials for new therapies; and
(5) facilitate review in the Food and Drug
Administration for the high need cures funded
by the CAN, through activities that may include—
(A) the facilitation of regular and ongoing
communication with the Food and Drug Administration regarding the status of activities conducted under this section;
(B) ensuring that such activities are coordinated with the approval requirements of
the Food and Drug Administration, with the
goal of expediting the development and approval of countermeasures and products; and
(C) connecting interested persons with additional technical assistance made available
under section 360bbb–4 of title 21.
(d) CAN Board
(1) Establishment
There is established a Cures Acceleration
Network Review Board (referred to in this section as the ‘‘Board’’), which shall advise the
Director of NIH on the conduct of the activities of the Cures Acceleration Network.
(2) Membership
(A) In general
(i) Appointment
The Board shall be comprised of 24 members who are appointed by the Secretary
and who serve at the pleasure of the Secretary.
(ii) Chairperson and Vice Chairperson
The Secretary shall designate, from
among the 24 members appointed under
clause (i), one Chairperson of the Board
(referred to in this section as the ‘‘Chairperson’’) and one Vice Chairperson.
(B) Terms
(i) In general
Each member shall be appointed to serve
a 4-year term, except that any member appointed to fill a vacancy occurring prior to
the expiration of the term for which the
member’s predecessor was appointed shall
be appointed for the remainder of such
term.
(ii) Consecutive appointments; maximum
terms
A member may be appointed to serve not
more than 3 terms on the Board, and may
not serve more than 2 such terms consecutively.
(C) Qualifications
(i) In general
The Secretary shall appoint individuals
to the Board based solely upon the individual’s established record of distinguished
service in one of the areas of expertise described in clause (ii). Each individual appointed to the Board shall be of distin-

§ 282d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

guished achievement and have a broad
range of disciplinary interests.
(ii) Expertise
The Secretary shall select individuals
based upon the following requirements:
(I) For each of the fields of—
(aa) basic research;
(bb) medicine;
(cc) biopharmaceuticals;
(dd) discovery and delivery of medical products;
(ee) bioinformatics and gene therapy;
(ff) medical instrumentation; and
(gg) regulatory review and approval
of medical products,
the Secretary shall select at least 1 individual who is eminent in such fields.
(II) At least 4 individuals shall be recognized leaders in professional venture
capital or private equity organizations
and have demonstrated experience in private equity investing.
(III) At least 8 individuals shall represent disease advocacy organizations.
(3) Ex-officio members
(A) Appointment
In addition to the 24 Board members described in paragraph (2), the Secretary shall
appoint as ex-officio members of the Board—
(i) a representative of the National Institutes of Health, recommended by the Secretary of the Department of Health and
Human Services;
(ii) a representative of the Office of the
Assistant Secretary of Defense for Health
Affairs, recommended by the Secretary of
Defense;
(iii) a representative of the Office of the
Under Secretary for Health for the Veterans Health Administration, recommended
by the Secretary of Veterans Affairs;
(iv) a representative of the National
Science Foundation, recommended by the
Chair of the National Science Board; and
(v) a representative of the Food and Drug
Administration, recommended by the
Commissioner of Food and Drugs.
(B) Terms
Each ex-officio member shall serve a 3year term on the Board, except that the
Chairperson may adjust the terms of the initial ex-officio members in order to provide
for a staggered term of appointment for all
such members.
(4) Responsibilities of the Board and the Director of NIH
(A) Responsibilities of the Board
(i) In general
The Board shall advise, and provide recommendations to, the Director of NIH
with respect to—
(I) policies, programs, and procedures
for carrying out the duties of the Director of NIH under this section; and
(II) significant barriers to successful
translation of basic science into clinical
application (including issues under the

Page 506

purview of other agencies and departments).
(ii) Report
In the case that the Board identifies a
significant barrier, as described in clause
(i)(II), the Board shall submit to the Secretary a report regarding such barrier.
(B) Responsibilities of the Director of NIH
With respect to each recommendation provided by the Board under subparagraph
(A)(i), the Director of NIH shall respond in
writing to the Board, indicating whether
such Director will implement such recommendation. In the case that the Director of
NIH indicates a recommendation of the
Board will not be implemented, such Director shall provide an explanation of the reasons for not implementing such recommendation.
(5) Meetings
(A) In general
The Board shall meet 4 times per calendar
year, at the call of the Chairperson.
(B) Quorum; requirements; limitations
(i) Quorum
A quorum shall consist of a total of 13
members of the Board, excluding ex-officio
members, with diverse representation as
described in clause (iii).
(ii) Chairperson or Vice Chairperson
Each meeting of the Board shall be attended by either the Chairperson or the
Vice Chairperson.
(iii) Diverse representation
At each meeting of the Board, there
shall be not less than one scientist, one
representative of a disease advocacy organization, and one representative of a professional venture capital or private equity
organization.
(6) Compensation and travel expenses
(A) Compensation
Members shall receive compensation at a
rate to be fixed by the Chairperson but not
to exceed a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5 for each day
(including travel time) during which the
member is engaged in the performance of the
duties of the Board. All members of the
Board who are officers or employees of the
United States shall serve without compensation in addition to that received for their
services as officers or employees of the
United States.
(B) Travel expenses
Members of the Board shall be allowed
travel expenses, including per diem in lieu of
subsistence, at rates authorized for persons
employed intermittently by the Federal
Government under section 5703(b) 3 of title 5,
3 So in original. Section 5703 of title 5 does not contain a subsec. (b).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

while away from their homes or regular
places of business in the performance of
services for the Board.
(e) Grant program
(1) Supporting innovation
To carry out the purposes described in this
section, the Director of NIH shall award contracts, grants, or cooperative agreements to
the entities described in paragraph (2), to—
(A) promote innovation in technologies
supporting the advanced research and development and production of high need cures,
including through the development of medical products and behavioral therapies.
(B) accelerate the development of high
need cures, including through the development of medical products, behavioral therapies, and biomarkers that demonstrate the
safety or effectiveness of medical products;
or
(C) help the award recipient establish protocols that comply with Food and Drug Administration standards and otherwise permit
the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.
(2) Eligible entities
To receive assistance under paragraph (1), an
entity shall—
(A) be a public or private entity, which
may include a private or public research institution, an institution of higher education,
a medical center, a biotechnology company,
a pharmaceutical company, a disease advocacy organization, a patient advocacy organization, or an academic research institution;
(B) submit an application containing—
(i) a detailed description of the project
for which the entity seeks such grant or
contract;
(ii) a timetable for such project;
(iii) an assurance that the entity will
submit—
(I) interim reports describing the entity’s—
(aa) progress in carrying out the
project; and
(bb) compliance with all provisions
of this section and conditions of receipt of such grant or contract; and
(II) a final report at the conclusion of
the grant period, describing the outcomes of the project; and
(iv) a description of the protocols the entity will follow to comply with Food and
Drug Administration standards and regulatory requirements at all stages of development, manufacturing, review, approval,
and safety surveillance of a medical product; and
(C) provide such additional information as
the Director of NIH may require.

§ 282d

(3) Awards
(A) The cures acceleration partnership
awards
(i) Initial award amount
Each award under this subparagraph
shall be not more than $15,000,000 per
project for the first fiscal year for which
the project is funded, which shall be payable in one payment.
(ii) Funding in subsequent fiscal years
An eligible entity receiving an award
under clause (i) may apply for additional
funding for such project by submitting to
the Director of NIH the information required under subparagraphs (B) and (C) of
paragraph (2). The Director may fund a
project of such eligible entity in an
amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award
under clause (i).
(iii) Matching funds
As a condition for receiving an award
under this subsection, an eligible entity
shall contribute to the project non-Federal
funds in the amount of $1 for every $3
awarded under clauses (i) and (ii), except
that the Director of NIH may waive or
modify such matching requirement in any
case where the Director determines that
the goals and objectives of this section
cannot adequately be carried out unless
such requirement is waived.
(B) The cures acceleration grant awards
(i) Initial award amount
Each award under this subparagraph
shall be not more than $15,000,000 per
project for the first fiscal year for which
the project is funded, which shall be payable in one payment.
(ii) Funding in subsequent fiscal years
An eligible entity receiving an award
under clause (i) may apply for additional
funding for such project by submitting to
the Board the information required under
subparagraphs (B) and (C) of paragraph (2).
The Director of NIH may fund a project of
such eligible entity in an amount not to
exceed $15,000,000 for a fiscal year subsequent to the initial award under clause (i).
(C) The cures acceleration flexible research
awards
If the Director of NIH determines that the
goals and objectives of this section cannot
adequately be carried out through a contract, grant, or cooperative agreement, the
Director of NIH shall have flexible research
authority to use other transactions to fund
projects in accordance with the terms and
conditions of this section. Awards made
under such flexible research authority for a
fiscal year shall not exceed 20 percent of the
total funds appropriated under subsection
(g)(1) for such fiscal year.
(4) Suspension of awards for defaults, noncompliance with provisions and plans, and
diversion of funds; repayment of funds
The Director of NIH may suspend the award
to any entity upon noncompliance by such en-

§ 283

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tity with provisions and plans under this section or diversion of funds.
(5) Audits
The Director of NIH may enter into agreements with other entities to conduct periodic
audits of the projects funded by grants or contracts awarded under this subsection.
(6) Closeout procedures
At the end of a grant or contract period, a
recipient shall follow the closeout procedures
under section 74.71 of title 45, Code of Federal
Regulations (or any successor regulation).
(7) Review
A determination by the Director of NIH as
to whether a drug, device, or biological product is a high need cure (for purposes of subsection (a)(3)) shall not be subject to judicial
review.
(f) Competitive basis of awards
Any grant, cooperative agreement, or contract
awarded under this section shall be awarded on
a competitive basis.
(g) Authorization of appropriations
(1) In general
For purposes of carrying out this section,
there are authorized to be appropriated
$500,000,000 for fiscal year 2010, and such sums
as may be necessary for subsequent fiscal
years. Funds appropriated under this section
shall be available until expended.
(2) Limitation on use of funds otherwise appropriated
No funds appropriated under this chapter,
other than funds appropriated under paragraph (1), may be allocated to the Cures Acceleration Network.
(July 1, 1944, ch. 373, title IV, § 402C, as added
Pub. L. 111–148, title X, § 10409(d), Mar. 23, 2010,
124 Stat. 978.)
REFERENCES IN TEXT
Section 262(i) of this title, referred to in subsec.
(a)(3), was in the original ‘‘section 262(i)’’, and was
translated as meaning section 351(i) of act July 1, 1944,
ch. 373, to reflect the probable intent of Congress.

§ 283. Biennial reports of Director of NIH
(a) In general
The Director of NIH shall submit to the Congress on a biennial basis a report in accordance
with this section. The first report shall be submitted not later than 1 year after January 15,
2007. Each such report shall include the following information:
(1) An assessment of the state of biomedical
and behavioral research.
(2) A description of the activities conducted
or supported by the agencies of the National
Institutes of Health and policies respecting
the programs of such agencies.
(3) Classification and justification for the
priorities established by the agencies, including a strategic plan and recommendations for
future research initiatives to be carried out
under section 282(b)(7) of this title through the
Division of Program Coordination, Planning,
and Strategic Initiatives.

Page 508

(4) A catalog of all the research activities of
the agencies, prepared in accordance with the
following:
(A) The catalog shall, for each such activity—
(i) identify the agency or agencies involved;
(ii) state whether the activity was carried out directly by the agencies or was
supported by the agencies and describe to
what extent the agency was involved; and
(iii) identify whether the activity was
carried out through a center of excellence.
(B) In the case of clinical research, the
catalog shall, as appropriate, identify study
populations by demographic variables and
other variables that contribute to research
on minority health and health disparities.
(C) Research activities listed in the catalog shall include, where applicable, the following:
(i) Epidemiological studies and longitudinal studies.
(ii) Disease registries, information clearinghouses, and other data systems.
(iii) Public education and information
campaigns.
(iv) Training activities, including—
(I) National Research Service Awards
and Clinical Transformation Science
Awards;
(II) graduate medical education programs, including information on the
number and type of graduate degrees
awarded during the period in which the
programs received funding under this
subchapter;
(III) investigator-initiated awards for
postdoctoral training and postdoctoral
training funded through research grants;
(IV) a breakdown by demographic variables and other appropriate categories;
and
(V) an evaluation and comparison of
outcomes and effectiveness of various
training programs.
(v) Clinical trials, including a breakdown
of participation by study populations and
demographic variables and such other information as may be necessary to demonstrate compliance with section 289a–2 of
this title (regarding inclusion of women
and minorities in clinical research).
(vi) Translational research activities
with other agencies of the Public Health
Service.
(5) A summary of the research activities
throughout the agencies, which summary shall
be organized by the following categories,
where applicable:
(A) Cancer.
(B) Neurosciences.
(C) Life stages, human development, and
rehabilitation.
(D) Organ systems.
(E) Autoimmune diseases.
(F) Genomics.
(G) Molecular biology and basic science.
(H) Technology development.
(I) Chronic diseases, including pain and
palliative care.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(J) Infectious diseases and bioterrorism.
(K) Minority health and health disparities.
(L) Such additional categories as the Director determines to be appropriate.
(6) A review of each entity receiving funding
under this subchapter in its capacity as a center of excellence (in this paragraph referred to
as a ‘‘center of excellence’’), including the following:
(A) An evaluation of the performance and
research outcomes of each center of excellence.
(B) Recommendations for promoting coordination of information among the centers
of excellence.
(C) Recommendations for improving the
effectiveness, efficiency, and outcomes of
the centers of excellence.
(D) If no additional centers of excellence
have been funded under this subchapter
since the previous report under this section,
an explanation of the reasons for not funding
any additional centers.
(b) Requirement regarding disease-specific research activities
In a report under subsection (a), the Director
of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—
(1) present information in a standardized format;
(2) identify the actual dollar amounts obligated for such activities; and
(3) include a plan for research on the specific
disease, disorder, or other adverse health condition, including a statement of objectives regarding the research, the means for achieving
the objectives, a date by which the objectives
are expected to be achieved, and justifications
for revisions to the plan.
(c) Additional reports
In addition to reports required by subsections
(a) and (b), the Director of NIH or the head of a
national research institute or national center
may submit to the Congress such additional reports as the Director or the head of such institute or center determines to be appropriate.
(July 1, 1944, ch. 373, title IV, § 403, as added Pub.
L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120
Stat. 3689; amended Pub. L. 110–85, title XI,
§ 1104(3), Sept. 27, 2007, 121 Stat. 975.)
PRIOR PROVISIONS
A prior section 283, act July 1, 1944, ch. 373, title IV,
§ 403, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat.
826; amended Pub. L. 100–607, title I, § 112, Nov. 4, 1988,
102 Stat. 3052, required a biennial report by the Director to the President and Congress, prior to repeal by
Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat.
3689.
AMENDMENTS
2007—Subsec. (a)(4)(C)(iv)(III). Pub. L. 110–85 inserted
‘‘and postdoctoral training funded through research
grants’’ before semicolon at end.
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an

§ 283a–1

Effective Date of 2007 Amendment note under section
281 of this title.

§ 283a. Annual reporting to increase interagency
collaboration and coordination
(a) Collaboration with other HHS agencies
On an annual basis, the Director of NIH shall
submit to the Secretary a report on the activities of the National Institutes of Health involving collaboration with other agencies of the Department of Health and Human Services.
(b) Clinical trials
Each calendar year, the Director of NIH shall
submit to the Commissioner of Food and Drugs
a report that identifies each clinical trial that is
registered during such calendar year in the
databank of information established under section 282(i) of this title.
(c) Human tissue samples
On an annual basis, the Director of NIH shall
submit to the Congress a report that describes
how the National Institutes of Health and its
agencies store and track human tissue samples.
(d) First report
The first report under subsections (a), (b), and
(c) shall be submitted not later than 1 year after
January 15, 2007.
(July 1, 1944, ch. 373, title IV, § 403A, as added
Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007,
120 Stat. 3691.)
PRIOR PROVISIONS
A prior section 403A of act July 1, 1944, was renumbered section 403D and is classified to section 283a–3 of
this title.
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 283a–1. Annual reporting to prevent fraud and
abuse
(a) Whistleblower complaints
(1) In general
On an annual basis, the Director of NIH shall
submit to the Inspector General of the Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on Appropriations
of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of
the Senate a report summarizing the activities of the National Institutes of Health relating to whistleblower complaints.
(2) Contents
For each whistleblower complaint pending
during the year for which a report is submitted under this subsection, the report shall
identify the following:
(A) Each agency of the National Institutes
of Health involved.
(B) The status of the complaint.
(C) The resolution of the complaint to
date.

§ 283a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Experts and consultants
On an annual basis, the Director of NIH shall
submit to the Inspector General of the Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce
and the Committee on Appropriations of the
House of Representatives, and the Committee on
Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate a
report that—
(1) identifies the number of experts and consultants, including any special consultants,
whose services are obtained by the National
Institutes of Health or its agencies;
(2) specifies whether such services were obtained under section 209(f) of this title, section
282(d) of this title, or other authority;
(3) describes the qualifications of such experts and consultants;
(4) describes the need for hiring such experts
and consultants; and
(5) if such experts and consultants make financial disclosures to the National Institutes
of Health or any of its agencies, specifies the
income, gifts, assets, and liabilities so disclosed.
(c) First report
The first report under subsections (a) and (b)
shall be submitted not later than 1 year after
January 15, 2007.
(July 1, 1944, ch. 373, title IV, § 403B, as added
Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007,
120 Stat. 3691.)
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 283a–2. Annual reporting regarding training of
graduate students for doctoral degrees
(a) In general
Each institution receiving an award under this
subchapter for the training of graduate students
for doctoral degrees shall annually report to the
Director of NIH, with respect to graduate students supported by the National Institutes of
Health at such institution—
(1) the percentage of such students admitted
for study who successfully attain a doctoral
degree; and
(2) for students described in paragraph (1),
the average time (not including any leaves of
absence) between the beginning of graduate
study and the receipt of a doctoral degree.
(3) 1 Provision of information to applicants
Each institution described in subsection (a)
shall provide to each student submitting an application for a program of graduate study at
such institution the information described in
paragraphs (1) and (2) of such subsection with respect to the program or programs to which such
student has applied.
(July 1, 1944, ch. 373, title IV, § 403C, as added
Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007,
1 So

in original. Probably should be ‘‘(b)’’.

Page 510

120 Stat. 3692; amended Pub. L. 110–85, title XI,
§ 1104(5), Sept. 27, 2007, 121 Stat. 975.)
PRIOR PROVISIONS
A prior section 403C of act July 1, 1944, was renumbered section 403D and is classified to section 283a–3 of
this title.
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–85, § 1104(5)(A), substituted ‘‘graduate students supported by the National
Institutes of Health’’ for ‘‘each degree-granting program’’ in introductory provisions.
Subsec. (a)(1). Pub. L. 110–85, § 1104(5)(B), inserted
‘‘such’’ after ‘‘percentage of’’.
Subsec. (a)(2). Pub. L. 110–85, § 1104(5)(C), inserted
‘‘(not including any leaves of absence)’’ after ‘‘average
time’’.
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 283a–3. Establishment of program regarding
DES
(a) In general
The Director of NIH shall establish a program
for the conduct and support of research and
training, the dissemination of health information, and other programs with respect to the diagnosis and treatment of conditions associated
with exposure to the drug diethylstilbestrol (in
this section referred to as ‘‘DES’’).
(b) Education programs
In carrying out subsection (a), the Director of
NIH, after consultation with nonprofit private
entities representing individuals who have been
exposed to DES, shall conduct or support programs to educate health professionals and the
public on the drug, including the importance of
identifying and treating individuals who have
been exposed to the drug.
(c) Longitudinal studies
After consultation with the Office of Research
on Women’s Health, the Director of NIH, acting
through the appropriate national research institutes, shall in carrying out subsection (a) conduct or support one or more longitudinal studies
to determine the incidence of the following diseases or disorders in the indicated populations
and the relationship of DES to the diseases or
disorders:
(1) In the case of women to whom (on or
after January 1, 1938) DES was administered
while the women were pregnant, the incidence
of all diseases and disorders (including breast
cancer, gynecological cancers, and impairments of the immune system, including autoimmune disease).
(2) In the case of women exposed to DES in
utero, the incidence of clear cell cancer (including recurrences), the long-term health effects of such cancer, and the effects of treatments for such cancer.
(3) In the case of men and women exposed to
DES in utero, the incidence of all diseases and
disorders (including impairments of the reproductive and autoimmune systems).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) In the case of children of men or women
exposed to DES in utero, the incidence of all
diseases and disorders.
(d) Exposure to DES in utero
For purposes of this section, an individual
shall be considered to have been exposed to DES
in utero if, during the pregnancy that resulted
in the birth of such individual, DES was (on or
after January 1, 1938) administered to the biological mother of the individual.
(July 1, 1944, ch. 373, title IV, § 403D, formerly
§ 403A, as added Pub. L. 102–409, § 2, Oct. 13, 1992,
106 Stat. 2092; amended Pub. L. 105–340, title I,
§ 101(a), Oct. 31, 1998, 112 Stat. 3191; renumbered
§ 403C and amended Pub. L. 109–482, title I,
§§ 103(b)(2), 104(a)(1), Jan. 15, 2007, 120 Stat. 3687,
3689; renumbered § 403D, Pub. L. 110–85, title XI,
§ 1104(4), Sept. 27, 2007, 121 Stat. 975.)
CODIFICATION
Section was formerly classified to section 283a of this
title prior to renumbering by Pub. L. 109–482.
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482, § 103(b)(2), struck
out subsec. (e) which read as follows: ‘‘In addition to
any other authorization of appropriations available for
the purpose of carrying out this section, there are authorized to be appropriated for such purpose such sums
as may be necessary for each of the fiscal years 1993
through 2003.’’
1998—Subsec. (e). Pub. L. 105–340 substituted ‘‘2003’’
for ‘‘1996’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 283b. Repealed. Pub. L. 106–525, title
§ 101(b)(2), Nov. 22, 2000, 114 Stat. 2501

I,

Section, act July 1, 1944, ch. 373, title IV, § 404, as
added Pub. L. 103–43, title I, § 151, June 10, 1993, 107 Stat.
139, related to the establishment and purpose of the Office of Research on Minority Health.

§ 283c. Office of Behavioral and Social Sciences
Research
(a) There is established within the Office of
the Director of NIH an office to be known as the
Office of Behavioral and Social Sciences Research (in this section referred to as the ‘‘Office’’). The Office shall be headed by a director,
who shall be appointed by the Director of NIH.
(b)(1) With respect to research on the relationship between human behavior and the development, treatment, and prevention of medical conditions, the Director of the Office shall—
(A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
(B) identify projects of behavioral and social
sciences research that should be conducted or
supported by the national research institutes,
and develop such projects in cooperation with
such institutes.
(2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent behavior, suicide, and homelessness. Such research does not include neuro-

§ 283d

biological research, or research in which the behavior of an organism is observed for the purpose of determining activity at the cellular or
molecular level.
(July 1, 1944, ch. 373, title IV, § 404A, as added
Pub. L. 103–43, title II, § 203(a), June 10, 1993, 107
Stat. 145.)
EFFECTIVE DATE
Section 203(c) of Pub. L. 103–43 provided that: ‘‘The
amendment described in subsection (a) [enacting this
section] is made upon the date of the enactment of this
Act [June 10, 1993] and takes effect July 1, 1993. Subsection (b) [107 Stat. 145] takes effect on such date.’’

§ 283d. Children’s Vaccine Initiative
(a) Development of new vaccines
The Secretary, in consultation with the Director of the National Vaccine Program under subchapter XIX of this chapter and acting through
the Directors of the National Institute for Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health
and Human Development, the National Institute
for Aging, and other public and private programs, shall carry out activities, which shall be
consistent with the global Children’s Vaccine
Initiative, to develop affordable new and improved vaccines to be used in the United States
and in the developing world that will increase
the efficacy and efficiency of the prevention of
infectious diseases. In carrying out such activities, the Secretary shall, to the extent practicable, develop and make available vaccines
that require fewer contacts to deliver, that can
be given early in life, that provide long lasting
protection, that obviate refrigeration, needles
and syringes, and that protect against a larger
number of diseases.
(b) Report
In the report required in section 300aa–4 1 of
this title, the Secretary, acting through the Director of the National Vaccine Program under
subchapter XIX of this chapter, shall include information with respect to activities and the
progress made in implementing the provisions of
this section and achieving its goals.
(July 1, 1944, ch. 373, title IV, § 404B, as added
Pub. L. 103–43, title II, § 204, June 10, 1993, 107
Stat. 146; amended Pub. L. 109–482, title I,
§ 103(b)(3), Jan. 15, 2007, 120 Stat. 3687; Pub. L.
110–154, § 1(b)(2), Dec. 21, 2007, 121 Stat. 1827.)
REFERENCES IN TEXT
Section 300aa–4 of this title, referred to in subsec. (b),
was repealed by Pub. L. 105–362, title VI, § 601(a)(1)(H),
Nov. 10, 1998, 112 Stat. 3285.
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–154 substituted ‘‘Eunice
Kennedy Shriver National Institute of Child Health and
Human Development’’ for ‘‘National Institute for Child
Health and Human Development’’.
Subsec. (c). Pub. L. 109–482 struck out heading and
text of subsec. (c). Text read as follows: ‘‘In addition to
any other amounts authorized to be appropriated for
activities of the type described in this section, there
are authorized to be appropriated to carry out this section $20,000,000 for fiscal year 1994, and such sums as
1 See

References in Text note below.

§ 283e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

may be necessary for each of the fiscal years 1995 and
1996.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 283e. Plan for use of animals in research
(a) Preparation
The Director of NIH, after consultation with
the committee established under subsection (e)
of this section, shall prepare a plan—
(1) for the National Institutes of Health to
conduct or support research into—
(A) methods of biomedical research and experimentation that do not require the use of
animals;
(B) methods of such research and experimentation that reduce the number of animals used in such research;
(C) methods of such research and experimentation that produce less pain and distress in such animals; and
(D) methods of such research and experimentation that involve the use of marine
life (other than marine mammals);
(2) for establishing the validity and reliability of the methods described in paragraph (1);
(3) for encouraging the acceptance by the
scientific community of such methods that
have been found to be valid and reliable; and
(4) for training scientists in the use of such
methods that have been found to be valid and
reliable.
(b) Submission to Congressional committees
Not later than October 1, 1993, the Director of
NIH shall submit to the Committee on Energy
and Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources of the Senate, the plan required in subsection (a) of this section and shall begin implementation of the plan.
(c) Periodic review and revision
The Director of NIH shall periodically review,
and as appropriate, make revisions in the plan
required under subsection (a) of this section. A
description of any revision made in the plan
shall be included in the first biennial report
under section 283 of this title that is submitted
after the revision is made.
(d) Dissemination of information
The Director of NIH shall take such actions as
may be appropriate to convey to scientists and
others who use animals in biomedical or behavioral research or experimentation information
respecting the methods found to be valid and reliable under subsection (a)(2) of this section.
(e) Interagency Coordinating Committee on the
Use of Animals in Research
(1) The Director of NIH shall establish within
the National Institutes of Health a committee
to be known as the Interagency Coordinating
Committee on the Use of Animals in Research
(in this subsection referred to as the ‘‘Committee’’).
(2) The Committee shall provide advice to the
Director of NIH on the preparation of the plan
required in subsection (a) of this section.

Page 512

(3) The Committee shall be composed of—
(A) the Directors of each of the national research institutes and the Director of the Center for Research Resources (or the designees of
such Directors); and
(B) representatives of the Environmental
Protection Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and
such additional agencies as the Director of
NIH determines to be appropriate, which representatives shall include not less than one
veterinarian with expertise in laboratory-animal medicine.
(July 1, 1944, ch. 373, title IV, § 404C, as added
Pub. L. 103–43, title II, § 205(a), June 10, 1993, 107
Stat. 146.)
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 283f. Requirements regarding surveys of sexual
behavior
With respect to any survey of human sexual
behavior proposed to be conducted or supported
through the National Institutes of Health, the
survey may not be carried out unless—
(1) the proposal has undergone review in accordance with any applicable requirements of
sections 289 and 289a of this title; and
(2) the Secretary, in accordance with section
289a–1 of this title, makes a determination
that the information expected to be obtained
through the survey will assist—
(A) in reducing the incidence of sexually
transmitted diseases, the incidence of infection with the human immunodeficiency
virus, or the incidence of any other infectious disease; or
(B) in improving reproductive health or
other conditions of health.
(July 1, 1944, ch. 373, title IV, § 404D, as added
Pub. L. 103–43, title II, § 207, June 10, 1993, 107
Stat. 148.)
PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND
AMERICAN TEENAGE SEX SURVEY
Section 2015 of Pub. L. 103–43 provided that: ‘‘The
Secretary of Health and Human Services may not during fiscal year 1993 or any subsequent fiscal year conduct or support the SHARP survey of adult sexual behavior or the American Teenage Study of adolescent
sexual behavior. This section becomes effective on the
date of the enactment of this Act [June 10, 1993].’’

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§ 283g. Muscular dystrophy; initiative through
Director of National Institutes of Health
(a) Expansion, intensification, and coordination
of activities
(1) In general
The Director of NIH, in coordination with
the Directors of the National Institute of Neurological Disorders and Stroke, the National
Institute of Arthritis and Muscoskeletal and
Skin Diseases, the Eunice Kennedy Shriver
National Institute of Child Health and Human
Development, the National Heart, Lung, and
Blood Institute, and the other national research institutes as appropriate, shall expand
and intensify programs of such Institutes with
respect to research and related activities concerning various forms of muscular dystrophy,
including
Duchenne,
myotonic,
facioscapulohumeral muscular dystrophy (referred to in this section as ‘‘FSHD’’) and other
forms of muscular dystrophy.
(2) Coordination
The Directors referred to in paragraph (1)
shall jointly coordinate the programs referred
to in such paragraph and consult with the
Muscular Dystrophy Interagency Coordinating
Committee established under section 6 of the
MD–CARE Act.1
(3) Allocations by Director of NIH
The Director of NIH shall allocate the
amounts appropriated to carry out this section for each fiscal year among the national
research institutes referred to in paragraph
(1).
(b) Centers of excellence
(1) In general
The Director of NIH shall award grants and
contracts under subsection (a)(1) of this section to public or nonprofit private entities to
pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding
research on various forms of muscular dystrophy. Such centers of excellence shall be
known as the ‘‘Paul D. Wellstone Muscular
Dystrophy Cooperative Research Centers’’.
(2) Research
Each center under paragraph (1) shall supplement but not replace the establishment of
a comprehensive research portfolio in all the
muscular dystrophies. As a whole, the centers
shall conduct basic and clinical research in all
forms of muscular dystrophy including early
detection, diagnosis, prevention, and treatment, including the fields of muscle biology,
genetics, noninvasive imaging, genetics, pharmacological and other therapies.
(3) Coordination of centers
The Director of NIH shall, as appropriate,
provide for the coordination of information
among centers under paragraph (1) and ensure
regular communication between such centers.
(4) Organization of centers
Each center under paragraph (1) shall use
the facilities of a single institution, or be
1 See

References in Text note below.

§ 283g

formed from a consortium of cooperating institutions, meeting such requirements as may
be prescribed by the Director of NIH.
(5) Duration of support
Support for a center established under paragraph (1) may be provided under this section
for a period of not to exceed 5 years. Such period may be extended for 1 or more additional
periods not exceeding 5 years if the operations
of such center have been reviewed by an appropriate technical and scientific peer review
group established by the Director of NIH and
if such group has recommended to the Director that such period should be extended.
(c) Facilitation of research
The Director of NIH shall provide for a program under subsection (a)(1) of this section
under which samples of tissues and genetic materials that are of use in research on muscular
dystrophy are donated, collected, preserved, and
made available for such research. The program
shall be carried out in accordance with accepted
scientific and medical standards for the donation, collection, and preservation of such samples.
(d) Coordinating Committee
(1) In general
The Secretary shall establish the Muscular
Dystrophy Coordinating Committee (referred
to in this section as the ‘‘Coordinating Committee’’) to coordinate activities across the
National Institutes and with other Federal
health programs and activities relating to the
various forms of muscular dystrophy.
(2) Composition
The Coordinating Committee shall consist of
not more than 15 members to be appointed by
the Secretary, of which—
(A) 2⁄3 of such members shall represent governmental agencies, including the directors
or their designees of each of the national research institutes involved in research with
respect to muscular dystrophy and representatives of all other Federal departments and agencies whose programs involve
health functions or responsibilities relevant
to such diseases, including the Centers for
Disease Control and Prevention, the Health
Resources and Services Administration and
the Food and Drug Administration and representatives of other governmental agencies
that serve children with muscular dystrophy, such as the Department of Education; and
(B) 1⁄3 of such members shall be public
members, including a broad cross section of
persons affected with muscular dystrophies
including parents or legal guardians, affected individuals, researchers, and clinicians.
Members appointed under subparagraph (B)
shall serve for a term of 3 years, and may
serve for an unlimited number of terms if reappointed.
(3) Chair
(A) In general
With respect to muscular dystrophy, the
Chair of the Coordinating Committee shall

§ 283g

TITLE 42—THE PUBLIC HEALTH AND WELFARE

serve as the principal advisor to the Secretary, the Assistant Secretary for Health,
and the Director of NIH, and shall provide
advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and to the heads
of other relevant agencies. The Coordinating
Committee shall select the Chair for a term
not to exceed 2 years.
(B) Appointment
The Chair of the Committee shall be appointed by and be directly responsible to the
Secretary.
(4) Administrative support; terms of service;
other provisions
The following shall apply with respect to the
Coordinating Committee:
(A) The Coordinating Committee shall receive necessary and appropriate administrative support from the Department of Health
and Human Services.
(B) The Coordinating Committee shall
meet as appropriate as determined by the
Secretary, in consultation with the chair.2
(e) Plan for HHS activities
(1) In general
Not later than 1 year after December 18,
2001, the Coordinating Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy
through the national research institutes and
shall periodically review and revise the plan.
The plan shall—
(A) provide for a broad range of research
and education activities relating to biomedical, epidemiological, psychosocial, and
rehabilitative issues, including studies of
the impact of such diseases in rural and underserved communities;
(B) identify priorities among the programs
and activities of the National Institutes of
Health regarding such diseases; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan
The plan under paragraph (1) shall, with respect to each form of muscular dystrophy, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dystrophy.
(B) Basic research concerning the etiology
and genetic links of the disease and potential causes of mutations.
(C) The development of improved screening
techniques.
(D) Basic and clinical research for the development and evaluation of new treatments, including new biological agents.
(E) Information and education programs
for health care professionals and the public.
(f) Public input
The Secretary shall, under subsection (a)(1) of
this section, provide for a means through which
the public can obtain information on the exist2 So

in original. Probably should be capitalized.

Page 514

ing and planned programs and activities of the
Department of Health and Human Services with
respect to various forms of muscular dystrophy
and through which the Secretary can receive
comments from the public regarding such programs and activities.
(g) Clinical research
The Coordinating Committee may evaluate
the potential need to enhance the clinical research infrastructure required to test emerging
therapies for the various forms of muscular dystrophy by prioritizing the achievement of the
goals related to this topic in the plan under subsection (e)(1).
(July 1, 1944, ch. 373, title IV, § 404E, as added
Pub. L. 107–84, § 3, Dec. 18, 2001, 115 Stat. 824;
amended Pub. L. 109–482, title I, §§ 103(b)(4),
104(b)(1)(A), Jan. 15, 2007, 120 Stat. 3687, 3692;
Pub. L. 110–154, § 1(b)(3), Dec. 21, 2007, 121 Stat.
1827; Pub. L. 110–361, § 2, Oct. 8, 2008, 122 Stat.
4010.)
REFERENCES IN TEXT
Section 6 of the MD–CARE Act, referred to in subsec.
(a)(2), is section 6 of Pub. L. 107–84, which was formerly
set out as a note under section 247b–18 of this title and
does not relate to establishment of a coordinating committee. However, subsec. (d) of this section contains
provisions relating to the establishment of the Muscular Dystrophy Coordinating Committee.
PRIOR PROVISIONS
A prior section 283g, act July 1, 1944, ch. 373, title IV,
§ 404E, as added Pub. L. 103–43, title II, § 209, June 10,
1993, 107 Stat. 149, related to Office of Alternative Medicine, prior to repeal by Pub. L. 105–277, div. A, § 101(f)
[title VI, § 601(1)], Oct. 21, 1998, 112 Stat. 2681–337,
2681–387.
AMENDMENTS
2008—Subsec. (a)(1). Pub. L. 110–361, § 2(b)(1), inserted
‘‘the National Heart, Lung, and Blood Institute,’’ after
‘‘the Eunice Kennedy Shriver National Institute of
Child Health and Human Development,’’.
Subsec. (b)(1). Pub. L. 110–361, § 2(b)(2), inserted at end
‘‘Such centers of excellence shall be known as the ‘Paul
D. Wellstone Muscular Dystrophy Cooperative Research Centers’.’’
Subsec. (f). Pub. L. 110–361, § 2(a), struck out subsec.
(f) which related to reports.
Subsec. (g). Pub. L. 110–361, § 2(a), (b)(3), added subsec.
(g) and redesignated former subsec. (g) as (f).
2007—Pub. L. 109–482, § 104(b)(1)(A)(ii), which directed
amendment of subsec. (b) by striking subsec. (f) and redesignating subsec. (g) as (f), could not literally be executed and was not executed in view of amendments by
Pub. L. 110–361. See 2008 Amendment notes above.
Subsec. (a)(1). Pub. L. 110–154 substituted ‘‘Eunice
Kennedy Shriver National Institute of Child Health and
Human Development’’ for ‘‘National Institute of Child
Health and Human Development’’.
Subsec. (b)(3). Pub. L. 109–482, § 104(b)(1)(A)(i), amended heading and text of par. (3) generally. Text read as
follows: ‘‘The Director of NIH—
‘‘(A) shall, as appropriate, provide for the coordination of information among centers under paragraph
(1) and ensure regular communication between such
centers; and
‘‘(B) shall require the periodic preparation of reports on the activities of the centers and the submission of the reports to the Director.’’
Subsec. (h). Pub. L. 109–482, § 103(b)(4), struck out
heading and text of subsec. (h). Text read as follows:
‘‘For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be nec-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

essary for each of fiscal years 2002 through 2006. The authorization of appropriations established in the preceding sentence is in addition to any other authorization
of appropriations that is available for conducting or
supporting through the National Institutes of Health
research and other activities with respect to muscular
dystrophy.’’

§ 283h

fects less than 200,000 persons in the United
States.
(July 1, 1944, ch. 373, title IV, § 404F, as added
Pub. L. 107–280, § 3, Nov. 6, 2002, 116 Stat. 1989;
amended Pub. L. 109–482, title I, §§ 103(b)(5),
104(b)(1)(B), Jan. 15, 2007, 120 Stat. 3687, 3693.)

EFFECTIVE DATE OF 2007 AMENDMENT

AMENDMENTS

Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

2007—Subsec.
(b)(1)(F),
(G).
Pub.
L.
109–482,
§ 104(b)(1)(B), struck out subpars. (F) and (G) which read
as follows:
‘‘(F) The Director shall biennially prepare a report
that describes the research and education activities on
rare diseases being conducted or supported through the
national research institutes and centers, and that identifies particular projects or types of projects that
should in the future be conducted or supported by the
national research institutes and centers or other entities in the field of research on rare diseases.
‘‘(G) The Director shall prepare the NIH Director’s
annual report to Congress on rare disease research conducted by or supported through the national research
institutes and centers.’’
Subsec. (d). Pub. L. 109–482, § 103(b)(5), struck out
heading and text of subsec. (d). Text read as follows:
‘‘For the purpose of carrying out this section, there are
authorized to be appropriated such sums as already
have been appropriated for fiscal year 2002, and
$4,000,000 for each of the fiscal years 2003 through 2006.’’

§ 283h. Office of Rare Diseases
(a) Establishment
There is established within the Office of the
Director of NIH an office to be known as the Office of Rare Diseases (in this section referred to
as the ‘‘Office’’), which shall be headed by a Director (in this section referred to as the ‘‘Director’’), appointed by the Director of NIH.
(b) Duties
(1) In general
The Director of the Office shall carry out
the following:
(A) The Director shall recommend an
agenda for conducting and supporting research on rare diseases through the national
research institutes and centers. The agenda
shall provide for a broad range of research
and education activities, including scientific
workshops and symposia to identify research
opportunities for rare diseases.
(B) The Director shall, with respect to rare
diseases, promote coordination and cooperation among the national research institutes
and centers and entities whose research is
supported by such institutes.
(C) The Director, in collaboration with the
directors of the other relevant institutes and
centers of the National Institutes of Health,
may enter into cooperative agreements with
and make grants for regional centers of excellence on rare diseases in accordance with
section 283i of this title.
(D) The Director shall promote the sufficient allocation of the resources of the National Institutes of Health for conducting
and supporting research on rare diseases.
(E) The Director shall promote and encourage the establishment of a centralized
clearinghouse for rare and genetic disease
information that will provide understandable information about these diseases to the
public, medical professionals, patients and
families.
(2) Principal advisor regarding orphan diseases
With respect to rare diseases, the Director
shall serve as the principal advisor to the Director of NIH and shall provide advice to other
relevant agencies. The Director shall provide
liaison with national and international patient, health and scientific organizations concerned with rare diseases.
(c) Definition
For purposes of this section, the term ‘‘rare
disease’’ means any disease or condition that af-

EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
FINDINGS AND PURPOSES
Pub. L. 107–280, § 2, Nov. 6, 2002, 116 Stat. 1988, provided that:
‘‘(a) FINDINGS.—Congress makes the following findings:
‘‘(1) Rare diseases and disorders are those which affect small patient populations, typically populations
smaller than 200,000 individuals in the United States.
Such diseases and conditions include Huntington’s
disease, amyotrophic lateral sclerosis (Lou Gehrig’s
disease), Tourette syndrome, Crohn’s disease, cystic
fibrosis, cystinosis, and Duchenne muscular dystrophy.
‘‘(2) For many years, the 25,000,000 Americans suffering from the over 6,000 rare diseases and disorders
were denied access to effective medicines because
prescription drug manufacturers could rarely make a
profit from marketing drugs for such small groups of
patients. The prescription drug industry did not adequately fund research into such treatments. Despite
the urgent health need for these medicines, they
came to be known as ‘orphan drugs’ because no companies would commercialize them.
‘‘(3) During the 1970s, an organization called the National Organization for Rare Disorders (NORD) was
founded to provide services and to lobby on behalf of
patients with rare diseases and disorders. NORD was
instrumental in pressing Congress for legislation to
encourage the development of orphan drugs.
‘‘(4) The Orphan Drug Act [Pub. L. 97–414, see Short
Title of 1983 Amendments note set out under section
301 of Title 21, Food and Drugs] created financial incentives for the research and production of such orphan drugs. New Federal programs at the National
Institutes of Health and the Food and Drug Administration encouraged clinical research and commercial
product development for products that target rare
diseases. An Orphan Products Board was established
to promote the development of drugs and devices for
rare diseases or disorders.
‘‘(5) Before 1983, some 38 orphan drugs had been developed. Since the enactment of the Orphan Drug Act

§ 283i

TITLE 42—THE PUBLIC HEALTH AND WELFARE

[Jan. 4, 1983], more than 220 new orphan drugs have
been approved and marketed in the United States and
more than 800 additional drugs are in the research
pipeline.
‘‘(6) Despite the tremendous success of the Orphan
Drug Act, rare diseases and disorders deserve greater
emphasis in the national biomedical research enterprise. The Office of Rare Diseases at the National Institutes of Health was created in 1993, but lacks a
statutory authorization.
‘‘(7) The National Institutes of Health has received
a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research.
‘‘(8) Notwithstanding such increases, funding for
rare diseases and disorders at the National Institutes
of Health has not increased appreciably.
‘‘(9) To redress this oversight, the Department of
Health and Human Services has proposed the establishment of a network of regional centers of excellence for research on rare diseases.
‘‘(b) PURPOSES.—The purposes of this Act [see Short
Title of 2002 Amendments note set out under section 201
of this title] are to—
‘‘(1) amend the Public Health Service Act [this
chapter] to establish an Office of Rare Diseases at the
National Institutes of Health; and
‘‘(2) increase the national investment in the development of diagnostics and treatments for patients
with rare diseases and disorders.’’

§ 283i. Rare disease regional centers of excellence
(a) Cooperative agreements and grants
(1) In general
The Director of the Office of Rare Diseases
(in this section referred to as the ‘‘Director’’),
in collaboration with the directors of the
other relevant institutes and centers of the
National Institutes of Health, may enter into
cooperative agreements with and make grants
to public or private nonprofit entities to pay
all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for regional centers of excellence for clinical research into, training in,
and demonstration of diagnostic, prevention,
control, and treatment methods for rare diseases.
(2) Policies
A cooperative agreement or grant under
paragraph (1) shall be entered into in accordance with policies established by the Director
of NIH.
(b) Coordination with other institutes
The Director shall coordinate the activities
under this section with similar activities conducted by other national research institutes,
centers and agencies of the National Institutes
of Health and by the Food and Drug Administration to the extent that such institutes, centers
and agencies have responsibilities that are related to rare diseases.
(c) Uses for Federal payments under cooperative
agreements or grants
Federal payments made under a cooperative
agreement or grant under subsection (a) of this
section may be used for—
(1) staffing, administrative, and other basic
operating costs, including such patient care
costs as are required for research;

Page 516

(2) clinical training, including training for
allied health professionals, continuing education for health professionals and allied
health professions personnel, and information
programs for the public with respect to rare
diseases; and
(3) clinical research and demonstration programs.
(d) Period of support; additional periods
Support of a center under subsection (a) of
this section may be for a period of not to exceed
5 years. Such period may be extended by the Director for additional periods of not more than 5
years if the operations of such center have been
reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to
the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, § 404G, as added
Pub. L. 107–280, § 4, Nov. 6, 2002, 116 Stat. 1990;
amended Pub. L. 109–482, title I, § 103(b)(6), Jan.
15, 2007, 120 Stat. 3687.)
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as already have been
appropriated for fiscal year 2002, and $20,000,000 for each
of the fiscal years 2003 through 2006.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 283j. Review of centers of excellence
(a) In general
Not later than April 1, 2008, and periodically
thereafter, the Secretary, acting through the
Director of NIH, shall conduct a review and submit a report to the appropriate committees of
the Congress on the centers of excellence.
(b) Report contents
Each report under subsection (a) shall include
the following:
(1) Evaluation of the performance and research outcomes of each center of excellence.
(2) Recommendations for promoting coordination of information among centers of excellence.
(3) Recommendations for improving the effectiveness, efficiency, and outcomes of the
centers of excellence.
(c) Definition
In this section, the term ‘‘center of excellence’’ means an entity receiving funding under
this subchapter in its capacity as a center of excellence.
(July 1, 1944, ch. 373, title IV, § 404H, as added
Pub. L. 109–416, § 2(b), Dec. 19, 2006, 120 Stat.
2821.)

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PART B—GENERAL PROVISIONS RESPECTING
NATIONAL RESEARCH INSTITUTES
§ 284. Directors of national research institutes
(a) Appointment
The Director of the National Cancer Institute
shall be appointed by the President and the Directors of the other national research institutes
shall be appointed by the Secretary. Each Director of a national research institute shall report
directly to the Director of NIH.
(b) Duties and authority; grants, contracts, and
cooperative agreements
(1) In carrying out the purposes of section 241
of this title with respect to human diseases or
disorders or other aspects of human health for
which the national research institutes were established, the Secretary, acting through the Director of each national research institute—
(A) shall encourage and support research, investigations, experiments, demonstrations,
and studies in the health sciences related to—
(i) the maintenance of health,
(ii) the detection, diagnosis, treatment,
and prevention of human diseases and disorders,
(iii) the rehabilitation of individuals with
human diseases, disorders, and disabilities,
and
(iv) the expansion of knowledge of the
processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and
the processes underlying the interactions between the human organism and the environment;
(B) may, subject to the peer review prescribed under section 289a(b) of this title and
any advisory council review under section
284a(a)(3)(A)(i) of this title, conduct the research, investigations, experiments, demonstrations, and studies referred to in subparagraph (A);
(C) may conduct and support research training (i) for which fellowship support is not provided under section 288 of this title, and (ii)
which is not residency training of physicians
or other health professionals;
(D) may develop, implement, and support
demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities;
(E) may develop, conduct, and support public
and professional education and information
programs;
(F) may secure, develop and maintain, distribute, and support the development and
maintenance of resources needed for research;
(G) may make available the facilities of the
institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies
charged with protecting the public health;
(H) may accept unconditional gifts made to
the institute for its activities, and, in the case
of gifts of a value in excess of $50,000, establish
suitable memorials to the donor;

§ 284

(I) may secure for the institute consultation
services and advice of persons from the United
States or abroad;
(J) may use, with their consent, the services,
equipment, personnel, information, and facilities of other Federal, State, or local public
agencies, with or without reimbursement
therefor;
(K) may accept voluntary and uncompensated services; and
(L) may perform such other functions as the
Secretary determines are needed to carry out
effectively the purposes of the institute.
The indemnification provisions of section 2354 of
title 10 shall apply with respect to contracts entered into under this subsection and section
282(b) of this title.
(2) Support for an activity or program under
this subsection may be provided through grants,
contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute—
(A) may enter into a contract for research,
training, or demonstrations only if the contract has been recommended after technical
and scientific peer review required by regulations under section 289a of this title;
(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that—
(i) if the direct cost of the grant or cooperative agreement to be made does not exceed
$50,000, such grant or cooperative agreement
may be made only if such grant or cooperative agreement has been recommended after
technical and scientific peer review required
by regulations under section 289a of this
title, and
(ii) if the direct cost of the grant or cooperative agreement to be made exceeds
$50,000, such grant or cooperative agreement
may be made only if such grant or cooperative agreement has been recommended after
technical and scientific peer review required
by regulations under section 289a of this
title and is recommended under section
284a(a)(3)(A)(ii) of this title by the advisory
council for the national research institute
involved; and
(C) shall, subject to section 300cc–40c(d)(2) of
this title, receive from the President and the
Office of Management and Budget directly all
funds appropriated by the Congress for obligation and expenditure by the Institute.
(c) Coordination with other public and private
entities; cooperation with other national research institutes; appointment of additional
peer review groups
In carrying out subsection (b) of this section,
each Director of a national research institute—
(1) shall coordinate, as appropriate, the activities of the institute with similar programs
of other public and private entities;
(2) shall cooperate with the Directors of the
other national research institutes in the development and support of multidisciplinary research and research that involves more than
one institute;
(3) may, in consultation with the advisory
council for the Institute and with the approval
of the Director of NIH—

§ 284a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) establish technical and scientific peer
review groups in addition to those appointed
under section 282(b)(16) of this title; and
(B) appoint the members of peer review
groups established under subparagraph (A);
and
(4) may publish, or arrange for the publication of, information with respect to the purpose of the Institute without regard to section
501 of title 44.
The Federal Advisory Committee Act shall not
apply to the duration of a peer review group appointed under paragraph (3).
(July 1, 1944, ch. 373, title IV, § 405, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 826; amended
Pub. L. 100–607, title I, § 116, Nov. 4, 1988, 102
Stat. 3053; Pub. L. 100–690, title II, § 2613(c), Nov.
18, 1988, 102 Stat. 4239; Pub. L. 103–43, title III,
§ 301(a)(1), (b), June 10, 1993, 107 Stat. 150; Pub. L.
109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120
Stat. 3685.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (c), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5,
Government Organization and Employees.
AMENDMENTS
2007—Subsec. (c)(3)(A). Pub. L. 109–482 substituted
‘‘section 282(b)(16)’’ for ‘‘section 282(b)(6)’’.
1993—Subsec. (b)(2)(C). Pub. L. 103–43, § 301(a)(1), added
subpar. (C).
Subsec. (c). Pub. L. 103–43, § 301(b)(2), inserted concluding provisions relating to Federal Advisory Committee Act.
Subsec. (c)(3). Pub. L. 103–43, § 301(b)(1), amended par.
(3) generally. Prior to amendment, par. (3) read as follows: ‘‘may, in consultation with the advisory council
for the Institute and the approval of the Director of
NIH, establish and appoint technical and scientific peer
review groups in addition to those established and appointed under section 282(b)(6) of this title; and’’.
1988—Subsec. (b)(1). Pub. L. 100–607, § 116(1), struck
out ‘‘the’’ after ‘‘with respect to’’ in introductory provisions.
Subsec. (c)(3). Pub. L. 100–690 substituted ‘‘establish
and appoint’’ and ‘‘established and appointed’’ for ‘‘establish’’ and ‘‘established’’, respectively.
Pub. L. 100–607, § 116(2)(A), amended par. (3) generally.
Prior to amendment, par. (3) read as follows: ‘‘may,
with the approval of the advisory council for the institute and the Director of NIH, appoint technical and scientific peer review groups in addition to those appointed under section 282(b)(6) of this title.’’
Subsec. (c)(4). Pub. L. 100–607, § 116(2)(C), added par.
(4).
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
ENHANCING THE CLINICAL AND TRANSLATIONAL SCIENCE
AWARD
Pub. L. 109–482, title I, § 106, Jan. 15, 2007, 120 Stat.
3696, provided that:

Page 518

‘‘(a) IN GENERAL.—In administering the Clinical and
Translational Science Award, the Director of NIH shall
establish a mechanism to preserve independent funding
and infrastructure for pediatric clinical research centers by—
‘‘(1) allowing the appointment of a secondary principal investigator under a single Clinical and
Translational Science Award, such that a pediatric
principal investigator may be appointed with direct
authority over a separate budget and infrastructure
for pediatric clinical research; or
‘‘(2) otherwise securing institutional independence
of pediatric clinical research centers with respect to
finances, infrastructure, resources, and research
agenda.
‘‘(b) REPORT.—As part of the biennial report under
section 403 of the Public Health Service Act [section 283
of this title], the Director of NIH shall provide an evaluation and comparison of outcomes and effectiveness of
training programs under subsection (a).
‘‘(c) DEFINITION.—For purposes of this section, the
term ‘Director of NIH’ has the meaning given such
term in section 401 of the Public Health Service Act
[section 281 of this title].’’

§ 284a. Advisory councils
(a) Establishment; acceptance of conditional
gifts; functions
(1) Except as provided in subsection (h) of this
section, the Secretary shall appoint an advisory
council for each national research institute
which (A) shall advise, assist, consult with, and
make recommendations to the Secretary and
the Director of such institute on matters related
to the activities carried out by and through the
institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C of this subchapter.
(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with section
238 of this title, of conditional gifts for study,
investigation, or research respecting the diseases, disorders, or other aspect of human health
with respect to which the institute was established, for the acquisition of grounds, or for the
construction, equipping, or maintenance of facilities for the institute.
(3) Each advisory council for a national research institute—
(A)(i) may on the basis of the materials provided under section 289a(b)(2) of this title respecting research conducted at the institute,
make recommendations to the Director of the
institute respecting such research,
(ii) may review applications for grants and
cooperative agreements for research or training and for which advisory council approval is
required under section 284(b)(2) of this title
and recommend for approval applications for
projects which show promise of making valuable contributions to human knowledge, and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or
entered into by the institute;
(B) may collect, by correspondence or by
personal investigation, information as to studies which are being carried on in the United
States or any other country as to the diseases,
disorders, or other aspect of human health
with respect to which the institute was established and with the approval of the Director of
the institute make available such information

Page 519

TITLE 42—THE PUBLIC HEALTH AND WELFARE

through appropriate publications for the benefit of public and private health entities and
health professions personnel and scientists
and for the information of the general public;
and
(C) may appoint subcommittees and convene
workshops and conferences.
(b) Membership; compensation
(1) Each advisory council shall consist of ex
officio members and not more than eighteen
members appointed by the Secretary. The ex
officio members shall be nonvoting members.
(2) The ex officio members of an advisory
council shall consist of—
(A) the Secretary, the Director of NIH, the
Director of the national research institute for
which the council is established, the Under
Secretary for Health of the Department of
Veterans Affairs or the Chief Dental Director
of the Department of Veterans Affairs, and the
Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of
the United States as the Secretary determines
necessary for the advisory council to effectively carry out its functions.
(3) The members of an advisory council who
are not ex officio members shall be appointed as
follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific
disciplines (including not less than two individuals who are leaders in the fields of public
health and the behavioral or social sciences)
relevant to the activities of the national research institute for which the advisory council
is established.
(B) One-third of the members shall be appointed by the Secretary from the general
public and shall include leaders in fields of
public policy, law, health policy, economics,
and management.
(4) Members of an advisory council who are officers or employees of the United States shall
not receive any compensation for service on the
advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council,
compensation at rates not to exceed the daily
equivalent of the annual rate in effect for grade
GS–18 of the General Schedule.
(c) Term of office; reappointment; vacancy
The term of office of an appointed member of
an advisory council is four years, except that
any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such term and the Secretary shall
make appointments to an advisory council in
such a manner as to ensure that the terms of the
members do not all expire in the same year. A
member may serve after the expiration of the
member’s term for 180 days after the date of
such expiration. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two
years from the date of expiration of such term of
office. If a vacancy occurs in the advisory coun-

§ 284a

cil among the appointed members, the Secretary
shall make an appointment to fill the vacancy
within 90 days from the date the vacancy occurs.
(d) Chairman; term of office
The chairman of an advisory council shall be
selected by the Secretary from among the appointed members, except that the Secretary
may select the Director of the national research
institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be
two years.
(e) Meetings
The advisory council shall meet at the call of
the chairman or upon the request of the Director of the national research institute for which
it was established, but at least three times each
fiscal year. The location of the meetings of each
advisory council is subject to the approval of
the Director of the national research institute
for which the advisory council was established.
(f) Appointment of executive secretary; training
and orientation for new members
The Director of the national research institute
for which an advisory council is established
shall designate a member of the staff of the institute to serve as the executive secretary of the
advisory council. The Director of such institute
shall make available to the advisory council
such staff, information, and other assistance as
it may require to carry out its functions. The
Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for
their effective participation in the functions of
the advisory council.
(g) Comments and recommendations for inclusion in biennial report; additional reports
Each advisory council may prepare, for inclusion in the biennial report made under section
284b 1 of this title, (1) comments respecting the
activities of the advisory council in the fiscal
years respecting which the report is prepared,
(2) comments on the progress of the national research institute for which it was established in
meeting its objectives, and (3) recommendations
respecting the future directions and program
and policy emphasis of the institute. Each advisory council may prepare such additional reports as it may determine appropriate.
(h) Advisory councils in existence; application of
section to National Cancer Advisory Board
and advisory council to National Heart,
Lung, and Blood Institute
(1) Except as provided in paragraph (2), this
section does not terminate the membership of
any advisory council for a national research institute which was in existence on November 20,
1985. After November 20, 1985—
(A) the Secretary shall make appointments
to each such advisory council in such a manner as to bring about as soon as practicable
the composition for such council prescribed by
this section;
(B) each advisory council shall organize itself in accordance with this section and exer1 See

References in Text note below.

§ 284b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cise the functions prescribed by this section;
and
(C) the Director of each national research institute shall perform for such advisory council
the functions prescribed by this section.
(2)(A) The National Cancer Advisory Board
shall be the advisory council for the National
Cancer Institute. This section applies to the National Cancer Advisory Board, except that—
(i) appointments to such Board shall be
made by the President;
(ii) the term of office of an appointed member shall be 6 years;
(iii) of the members appointed to the Board
not less than five members shall be individuals
knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors);
(iv) the chairman of the Board shall be selected by the President from the appointed
members and shall serve as chairman for a
term of two years;
(v) the ex officio members of the Board shall
be nonvoting members and shall be the Secretary, the Director of the Office of Science
and Technology Policy, the Director of NIH,
the Under Secretary for Health of the Department of Veterans Affairs, the Director of the
National Institute for Occupational Safety
and Health, the Director of the National Institute of Environmental Health Sciences, the
Secretary of Labor, the Commissioner of the
Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product
Safety Commission, the Assistant Secretary of
Defense for Health Affairs, and the Director of
the Office of Science of the Department of Energy (or the designees of such officers); and
(vi) the Board shall meet at least four times
each fiscal year.
(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall
meet at least four times each fiscal year.
(July 1, 1944, ch. 373, title IV, § 406, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 828; amended
Pub. L. 100–607, title I, § 117, Nov. 4, 1988, 102
Stat. 3053; Pub. L. 101–381, title I, § 102(1), Aug.
18, 1990, 104 Stat. 585; Pub. L. 102–405, title III,
§ 302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L.
103–43, title II, § 210(a), title XX, §§ 2008(b)(1),
2010(b)(2), June 10, 1993, 107 Stat. 149, 210, 214;
Pub. L. 105–245, title III, § 309(b)(2)(C), Oct. 7,
1998, 112 Stat. 1853.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (g),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
AMENDMENTS
1998—Subsec. (h)(2)(A)(v). Pub. L. 105–245 substituted
‘‘Science of the Department of Energy’’ for ‘‘Energy
Research of the Department of Energy’’.
1993—Subsec. (a)(2). Pub. L. 103–43, § 2010(b)(2), substituted ‘‘section 238’’ for ‘‘section 300aaa’’.
Subsec. (b)(2)(A). Pub. L. 103–43, § 2008(b)(1)(A), substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’ in two places.
Subsec. (c). Pub. L. 103–43, § 210(a), substituted ‘‘for
180 days after the date of such expiration’’ for ‘‘until a
successor has taken office’’.

Page 520

Subsec. (h)(2)(A)(v). Pub. L. 103–43, § 2008(b)(1)(B), substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1992—Subsecs. (b)(2)(A), (h)(2)(A)(v). Pub. L. 102–405
substituted ‘‘Under Secretary for Health’’ for ‘‘Chief
Medical Director’’.
1990—Subsec. (a)(2). Pub. L. 101–381 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
1988—Subsec. (b)(1). Pub. L. 100–607, § 117(a), inserted
at end ‘‘The ex officio members shall be nonvoting
members.’’
Subsec. (b)(3)(A). Pub. L. 100–607, § 117(b), inserted
‘‘not less than two individuals who are leaders in the
fields of’’ after ‘‘(including’’.
Subsec. (h)(2)(A)(v). Pub. L. 100–607, § 117(c), inserted
‘‘shall be nonvoting members and’’ after ‘‘Board’’ and
substituted ‘‘the Assistant Secretary of Defense for
Health Affairs, and the Director of the Office of Energy
Research of the Department of Energy’’ for ‘‘and the
Assistant Secretary of Defense for Health Affairs’’.
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by the Congress, its duration is
otherwise provided by law. See sections 3(2) and 14 of
Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in
the Appendix to Title 5, Government Organization and
Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 284b. Repealed. Pub. L. 109–482, title
§ 104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693

I,

Section, act July 1, 1944, ch. 373, title IV, § 407, as
added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 831, related to biennial report and its contents.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 284c. Certain uses of funds
(a)(1) Except as provided in paragraph (2), the
sum of the amounts obligated in any fiscal year
for administrative expenses of the National Institutes of Health may not exceed an amount
which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center

Page 521

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for Nursing Research, the John E. Fogarty
International Center for Advanced Study in the
Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.
(3) For purposes of paragraph (1), the term
‘‘administrative expenses’’ means expenses incurred for the support of activities relevant to
the award of grants, contracts, and cooperative
agreements and expenses incurred for general
administration of the scientific programs and
activities of the National Institutes of Health.
(b) For fiscal year 1989 and subsequent fiscal
years, amounts made available to the National
Institutes of Health shall be available for payment of nurses and allied health professionals in
accordance with payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38 for nurses of
the Department of Veterans Affairs.
(July 1, 1944, ch. 373, title IV, § 408, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 831; amended
Pub. L. 100–607, title I, § 118, Nov. 4, 1988, 102
Stat. 3053; Pub. L. 100–690, title II, § 2613(d), Nov.
18, 1988, 102 Stat. 4239; Pub. L. 103–43, title IV,
§ 403(b)(1), title XX, § 2008(b)(2), June 10, 1993, 107
Stat. 158, 211; Pub. L. 104–316, title I, § 122(a), Oct.
19, 1996, 110 Stat. 3836; Pub. L. 105–362, title VI,
§ 601(a)(1)(B), Nov. 10, 1998, 112 Stat. 3285.)
AMENDMENTS
1998—Subsec. (a)(4). Pub. L. 105–362 struck out par. (4)
which read as follows: ‘‘Not later than December 31,
1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for administrative expenses of the National Institutes of Health
and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary
shall consult with the Comptroller General of the
United States in preparing each report.’’
1996—Subsec. (a)(3). Pub. L. 104–316 struck out at end
‘‘In identifying expenses incurred for such support and
administration the Secretary shall consult with the
Comptroller General of the United States.’’
1993—Pub. L. 103–43 amended section catchline generally, redesignated subsec. (b) as (a) and par. (5) of subsec. (a) as (b), struck out former subsec. (a) which authorized appropriations in addition to amounts otherwise appropriated under this subchapter for the National Cancer Institute for programs other than under
section 285a–1 of this title and for its program under
section 285a–1 of this title and for the National Heart,
Lung, and Blood Institute for programs other than
under section 285b–1 of this title and for its program
under section 285b–1 of this title, and substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’ in subsec. (b).
1988—Subsec. (a)(1), (2). Pub. L. 100–607, § 118(a),
amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows:
‘‘(1)(A) For the National Cancer Institute (other than
its programs under section 285a–1 of this title), there
are authorized to be appropriated $1,194,000,000 for fiscal
year 1986, $1,270,000,000 for fiscal year 1987, and
$1,344,000,000 for fiscal year 1988.
‘‘(B) For the programs under section 285a–1 of this
title, there are authorized to be appropriated $68,000,000
for fiscal year 1986, $74,000,000 for fiscal year 1987, and
$80,000,000 for fiscal year 1988.
‘‘(2)(A) For the National Heart, Lung, and Blood Institute (other than its programs under section 285b–1 of
this title), there are authorized to be appropriated
$809,000,000 for fiscal year 1986, $871,000,000 for fiscal
year 1987, and $927,000,000 for fiscal year 1988. Of the

§ 284d

amount appropriated under this subsection for such fiscal year, not less than 15 percent of such amount shall
be reserved for programs respecting diseases of the lung
and not less than 15 percent of such amount shall be reserved for programs respecting blood diseases and blood
resources.
‘‘(B) For the programs under section 285b–1 of this
title, there are authorized to be appropriated $82,000,000
for fiscal year 1986, $90,000,000 for fiscal year 1987, and
$98,000,000 for fiscal year 1988.’’
Subsec. (a)(2)(B). Pub. L. 100–690 inserted a comma
after ‘‘section 285b–1 of this title’’.
Subsec. (b)(5). Pub. L. 100–607, § 118(b), added par. (5).
CHANGE OF NAME
National Center for Nursing Research changed to National Institute of Nursing Research by Pub. L. 103–43,
title XV, § 1511, June 10, 1993, 107 Stat. 178.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
WARREN G. MAGNUSON CLINICAL CENTER; AVAILABILITY
OF FUNDS FOR PAYMENT OF NURSES; RATE OF PAY
AND OPTIONS AND BENEFITS
Pub. L. 99–349, title I, July 2, 1986, 100 Stat. 738, provided that: ‘‘Funds made available for fiscal year 1986
and hereafter to the Warren G. Magnuson Clinical Center of the National Institutes of Health shall be available for payment of nurses at the rates of pay and with
schedule options and benefits authorized for the Veterans Administration pursuant to 38 U.S.C. 4107.’’

§ 284d. Definitions
(a) Health service research
For purposes of this subchapter, the term
‘‘health services research’’ means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes
of care. Such term does not include research on
the efficacy of services to prevent, diagnose, or
treat medical conditions.
(b) Clinical research
As used in this subchapter, the term ‘‘clinical
research’’ means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease
in human populations involving material of
human origin (such as tissue specimens and cognitive phenomena) for which an investigator or
colleague directly interacts with human subjects in an outpatient or inpatient setting to
clarify a problem in human physiology,
pathophysiology or disease, or epidemiologic or
behavioral studies, outcomes research or health
services research, or developing new technologies, therapeutic interventions, or clinical
trials.
(July 1, 1944, ch. 373, title IV, § 409, as added Pub.
L. 102–321, title I, § 121(b), July 10, 1992, 106 Stat.
358; amended Pub. L. 103–43, title XX, § 2016(a),
June 10, 1993, 107 Stat. 218; Pub. L. 106–505, title
II, § 206, Nov. 13, 2000, 114 Stat. 2329.)
AMENDMENTS
2000—Pub. L. 106–505 designated existing provisions as
subsec. (a), inserted heading, and added subsec. (b).
1993—Pub. L. 103–43 inserted at end ‘‘Such term does
not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.’’

§ 284e

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 284e. Research on osteoporosis, Paget’s disease,
and related bone disorders
(a) Establishment
The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases,
the National Institute on Aging, the National
Institute of Dental Research, and the National
Institute of Diabetes and Digestive and Kidney
Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget’s disease, and related bone disorders.
(b) Coordination
The Directors referred to in subsection (a) of
this section shall jointly coordinate the programs referred to in such subsection and consult
with the Arthritis and Musculoskeletal Diseases
Interagency Coordinating Committee and the
Interagency Task Force on Aging Research.
(c) Information clearinghouse
(1) In general
In order to assist in carrying out the purpose
described in subsection (a) of this section, the
Director of NIH shall provide for the establishment of an information clearinghouse on
osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals,
patients, and the public through the effective
dissemination of information.
(2) Establishment through grant or contract
For the purpose of carrying out paragraph
(1), the Director of NIH shall enter into a
grant, cooperative agreement, or contract
with a nonprofit private entity involved in activities regarding the prevention and control
of osteoporosis and related bone disorders.
(July 1, 1944, ch. 373, title IV, § 409A, as added
Pub. L. 103–43, title III, § 302, June 10, 1993, 107
Stat. 151; amended Pub. L. 105–340, title I, § 102,
Oct. 31, 1998, 112 Stat. 3192; Pub. L. 109–482, title
I, § 103(b)(7), Jan. 15, 2007, 120 Stat. 3687.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the fiscal years 1995 through 2003.’’
1998—Subsec. (d). Pub. L. 105–340 substituted
‘‘through 2003’’ for ‘‘and 1996’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 284f. Parkinson’s disease
(a) In general
The Director of NIH shall establish a program
for the conduct and support of research and

Page 522

training with respect to Parkinson’s disease
(subject to the extent of amounts appropriated
to carry out this section).
(b) Inter-institute coordination
(1) In general
The Director of NIH shall provide for the coordination of the program established under
subsection (a) of this section among all of the
national research institutes conducting Parkinson’s disease research.
(2) Conference
Coordination under paragraph (1) shall include the convening of a research planning
conference not less frequently than once every
2 years. Each such conference shall prepare
and submit to the Committee on Appropriations and the Committee on Labor and Human
Resources of the Senate and the Committee on
Appropriations and the Committee on Commerce of the House of Representatives a report
concerning the conference.
(c) Morris K. Udall research centers
(1) In general
The Director of NIH is authorized to award
Core Center Grants to encourage the development of innovative multidisciplinary research
and provide training concerning Parkinson’s
disease. The Director is authorized to award
not more than 10 Core Center Grants and designate each center funded under such grants as
a Morris K. Udall Center for Research on Parkinson’s Disease.
(2) Requirements
(A) In general
With respect to Parkinson’s disease, each
center assisted under this subsection shall—
(i) use the facilities of a single institution or a consortium of cooperating institutions, and meet such qualifications as
may be prescribed by the Director of the
NIH; and
(ii) conduct basic and clinical research.
(B) Discretionary requirements
With respect to Parkinson’s disease, each
center assisted under this subsection may—
(i) conduct training programs for scientists and health professionals;
(ii) conduct programs to provide information and continuing education to health
professionals;
(iii) conduct programs for the dissemination of information to the public;
(iv) separately or in collaboration with
other centers, establish a nationwide data
system derived from patient populations
with Parkinson’s disease, and where possible, comparing relevant data involving
general populations;
(v) separately or in collaboration with
other centers, establish a Parkinson’s Disease Information Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson’s disease; and
(vi) separately or in collaboration with
other centers, establish a national education program that fosters a national
focus on Parkinson’s disease and the care
of those with Parkinson’s disease.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Stipends regarding training programs
A center may use funds provided under paragraph (1) to provide stipends for scientists and
health professionals enrolled in training programs under paragraph (2)(B).
(4) Duration of support
Support of a center under this subsection
may be for a period not exceeding five years.
Such period may be extended by the Director
of NIH for one or more additional periods of
not more than five years if the operations of
such center have been reviewed by an appropriate technical and scientific peer review
group established by the Director and if such
group has recommended to the Director that
such period should be extended.
(d) Morris K. Udall Awards for Excellence in Parkinson’s Disease Research
The Director of NIH is authorized to establish
a grant program to support investigators with a
proven record of excellence and innovation in
Parkinson’s disease research and who demonstrate potential for significant future breakthroughs
in
the
understanding
of
the
pathogensis,1 diagnosis, and treatment of Parkinson’s disease. Grants under this subsection
shall be available for a period of not to exceed 5
years.
(July 1, 1944, ch. 373, title IV, § 409B, as added
Pub. L. 105–78, title VI, § 603(c), Nov. 13, 1997, 111
Stat. 1520; amended Pub. L. 109–482, title I,
§ 103(b)(8), Jan. 15, 2007, 120 Stat. 3687.)
AMENDMENTS
2007—Subsec. (a). Pub. L. 109–482, § 103(b)(8)(A), substituted ‘‘to carry out this section’’ for ‘‘under subsection (e) of this section’’.
Subsec. (e). Pub. L. 109–482, § 103(b)(8)(B), struck out
heading and text of subsec. (e). Text read as follows:
‘‘For the purpose of carrying out this section and section 241 of this title and this subchapter with respect to
research focused on Parkinson’s disease, there are authorized to be appropriated up to $100,000,000 for fiscal
year 1998, and such sums as may be necessary for each
of the fiscal years 1999 and 2000.’’
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
ADDITIONAL GRANTS
Pub. L. 108–199, div. E, title II, § 217, Jan. 23, 2004, 118
Stat. 255, provided that: ‘‘Notwithstanding section
409B(c) of the Public Health Service Act [subsec. (c) of
this section] regarding a limitation on the number of
1 So

in original. Probably should be ‘‘pathogenesis,’’.

§ 284g

such grants, funds appropriated in this Act [div. E of
Pub. L. 108–199, see Tables for classification] and Acts
in fiscal years thereafter may be expended by the Director of the National Institutes of Health to award
Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson’s disease. Each center funded
under such grants shall be designated as a Morris K.
Udall Center for Research on Parkinson’s Disease.’’
Similar provisions were contained in Pub. L. 108–7,
div. G, title II, § 218, Feb. 20, 2003, 117 Stat. 326.
FINDING AND PURPOSE
Section 603(b) of Pub. L. 105–78 provided that:
‘‘(1) FINDING.—Congress finds that to take full advantage of the tremendous potential for finding a cure or
effective treatment, the Federal investment in Parkinson’s disease must be expanded, as well as the coordination strengthened among the National Institutes of
Health research institutes.
‘‘(2) PURPOSE.—It is the purpose of this section [enacting this section] to provide for the expansion and coordination of research regarding Parkinson’s disease,
and to improve care and assistance for afflicted individuals and their family caregivers.’’

§ 284g. Expansion, intensification, and coordination of activities of National Institutes of
Health with respect to research on autism
spectrum disorder
(a) In general
(1) Expansion of activities
The Director of NIH (in this section referred
to as the ‘‘Director’’) shall, subject to the
availability of appropriations, expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including
basic and clinical research in fields including
pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition,
immunology,
neuroimmunology,
neurobehavioral development, endocrinology,
gastroenterology, and toxicology. Such research shall investigate the cause (including
possible environmental causes), diagnosis or
rule out, early detection, prevention, services,
supports, intervention, and treatment of autism spectrum disorder.
(2) Consolidation
The Director may consolidate program activities under this section if such consolidation would improve program efficiencies and
outcomes.
(3) Administration of program; collaboration
among agencies
The Director shall carry out this section
acting through the Director of the National
Institute of Mental Health and in collaboration with any other agencies that the Director
determines appropriate.
(b) Centers of excellence
(1) In general
The Director shall under subsection (a)(1) of
this section make awards of grants and contracts to public or nonprofit private entities
to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism spectrum disorder.

§ 284h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Research
Each center under paragraph (1) shall conduct basic and clinical research into autism
spectrum disorder. Such research should include investigations into the cause, diagnosis,
early detection, prevention, control, and
treatment of autism spectrum disorder. The
centers, as a group, shall conduct research including
the
fields
of
developmental
neurobiology,
genetics,
and
psychopharmacology.
(3) Services for patients
(A) In general
A center under paragraph (1) may expend
amounts provided under such paragraph to
carry out a program to make individuals
aware of opportunities to participate as subjects in research conducted by the centers.
(B) Referrals and costs
A program under subparagraph (A) may, in
accordance with such criteria as the Director may establish, provide to the subjects
described in such subparagraph, referrals for
health and other services, and such patient
care costs as are required for research.
(C) Availability and access
The extent to which a center can demonstrate availability and access to clinical
services shall be considered by the Director
in decisions about awarding grants to applicants which meet the scientific criteria for
funding under this section.
(4) Organization of centers
Each center under paragraph (1) shall use
the facilities of a single institution, or be
formed from a consortium of cooperating institutions, meeting such requirements as may
be prescribed by the Director.
(5) Number of centers; duration of support
(A) In general
The Director shall provide for the establishment of not less than five centers under
paragraph (1).
(B) Duration
Support for a center established under
paragraph (1) may be provided under this
section for a period of not to exceed 5 years.
Such period may be extended for one or
more additional periods not exceeding 5
years if the operations of such center have
been reviewed by an appropriate technical
and scientific peer review group established
by the Director and if such group has recommended to the Director that such period
should be extended.
(c) Facilitation of research
The Director shall under subsection (a)(1) of
this section provide for a program under which
samples of tissues and genetic materials that
are of use in research on autism spectrum disorder are donated, collected, preserved, and
made available for such research. The program
shall be carried out in accordance with accepted
scientific and medical standards for the donation, collection, and preservation of such samples.

Page 524

(d) Public input
The Director shall under subsection (a)(1) of
this section provide for means through which
the public can obtain information on the existing and planned programs and activities of the
National Institutes of Health with respect to autism spectrum disorder and through which the
Director can receive comments from the public
regarding such programs and activities.
(July 1, 1944, ch. 373, title IV, § 409C, as added
Pub. L. 106–310, div. A, title I, § 101, Oct. 17, 2000,
114 Stat. 1105; amended Pub. L. 109–416, §§ 2(a),
4(b), Dec. 19, 2006, 120 Stat. 2821, 2830; Pub. L.
109–482, title I, §§ 103(b)(9), 104(b)(1)(D), Jan. 15,
2007, 120 Stat. 3687, 3693.)
PRIOR PROVISIONS
Another section 409C of act July 1, 1944, was renumbered section 409G and is classified to section 284k of
this title.
AMENDMENTS
2007—Subsec. (b)(4) to (6). Pub. L. 109–482,
§ 104(b)(1)(D), redesignated pars. (5) and (6) as (4) and (5),
respectively, and struck out heading and text of former
par. (4). Text read as follows: ‘‘The Director shall, as
appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers, and may require the periodic preparation of reports on the activities of the centers and the submission of the reports to
the Director.’’
Subsec. (e). Pub. L. 109–482, § 103(b)(9), which directed
the striking of subsec. (e), could not be executed because of prior amendment by Pub. L. 109–416. See 2006
Amendment note below.
2006—Pub. L. 109–416, § 2(a)(1), substituted ‘‘autism
spectrum disorder’’ for ‘‘autism’’ in section catchline.
Subsec. (a). Pub. L. 109–416, § 2(a)(3), added pars. (1)
and (2), redesignated former par. (2) as (3), and struck
out heading and text of former par. (1). Text read as follows: ‘‘The Director of NIH (in this section referred to
as the ‘Director’) shall expand, intensify, and coordinate the activities of the National Institutes of Health
with respect to research on autism.’’
Subsec. (b)(1), (2). Pub. L. 109–416, § 2(a)(2), substituted
‘‘autism spectrum disorder’’ for ‘‘autism’’ in par. (1)
and in two places in par. (2).
Subsecs. (c), (d). Pub. L. 109–416, § 2(a)(2), substituted
‘‘autism spectrum disorder’’ for ‘‘autism’’.
Subsec. (e). Pub. L. 109–416, § 4(b), struck out heading
and text of subsec. (e). Text read as follows: ‘‘There are
authorized to be appropriated such sums as may be necessary to carry out this section. Amounts appropriated
under this subsection are in addition to any other
amounts appropriated for such purpose.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 284h. Pediatric Research Initiative
(a) Establishment
The Secretary shall establish within the Office
of the Director of NIH a Pediatric Research Initiative (referred to in this section as the ‘‘Initiative’’) to conduct and support research that is
directly related to diseases, disorders, and other
conditions in children. The Initiative shall be
headed by the Director of NIH.
(b) Purpose
The purpose of the Initiative is to provide
funds to enable the Director of NIH—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) to increase support for pediatric biomedical research within the National Institutes of Health to realize the expanding opportunities for advancement in scientific investigations and care for children;
(2) to enhance collaborative efforts among
the Institutes to conduct and support multidisciplinary research in the areas that the Director deems most promising; and
(3) in coordination with the Food and Drug
Administration, to increase the development
of adequate pediatric clinical trials and pediatric use information to promote the safer and
more effective use of prescription drugs in the
pediatric population.
(c) Duties
In carrying out subsection (b) of this section,
the Director of NIH shall—
(1) consult with the Director of the Eunice
Kennedy Shriver National Institute of Child
Health and Human Development and the other
national research institutes, in considering
their requests for new or expanded pediatric
research efforts, and consult with the Administrator of the Health Resources and Services
Administration and other advisors as the Director determines to be appropriate;
(2) have broad discretion in the allocation of
any Initiative assistance among the Institutes, among types of grants, and between
basic and clinical research so long as the assistance is directly related to the illnesses and
conditions of children; and
(3) be responsible for the oversight of any
newly appropriated Initiative funds and annually report to Congress and the public on the
extent of the total funds obligated to conduct
or support pediatric research across the National Institutes of Health, including the specific support and research awards allocated
through the Initiative.
(d) Transfer of funds
The Director of NIH may transfer amounts appropriated under this section to any of the Institutes for a fiscal year to carry out the purposes
of the Initiative under this section.
(July 1, 1944, ch. 373, title IV, § 409D, as added
Pub. L. 106–310, div. A, title X, § 1001, Oct. 17,
2000, 114 Stat. 1127; amended Pub. L. 109–482, title
I, § 103(b)(10), Jan. 15, 2007, 120 Stat. 3687; Pub. L.
110–154, § 1(b)(4), Dec. 21, 2007, 121 Stat. 1827.)
CODIFICATION
Another section 409D of act July 1, 1944, was renumbered section 409H and is classified to section 284l of
this title.
AMENDMENTS
2007—Subsec. (c)(1). Pub. L. 110–154 substituted ‘‘Eunice Kennedy Shriver National Institute of Child
Health and Human Development’’ for ‘‘National Institute of Child Health and Human Development’’.
Subsecs. (d), (e). Pub. L. 109–482 redesignated subsec.
(e) as (d) and struck out heading and text of former
subsec. (d). Text read as follows: ‘‘For the purpose of
carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal years 2002
through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or

§ 284i

subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 284i. Autoimmune diseases
(a) Expansion, intensification, and coordination
of activities
(1) In general
The Director of NIH shall expand, intensify,
and coordinate research and other activities of
the National Institutes of Health with respect
to autoimmune diseases.
(2) Allocations by Director of NIH
With respect to amounts appropriated to
carry out this section for a fiscal year, the Director of NIH shall allocate the amounts
among the national research institutes that
are carrying out paragraph (1).
(3) Definition
The term ‘‘autoimmune disease’’ includes,
for purposes of this section such diseases or
disorders with evidence of autoimmune
pathogensis 1 as the Secretary determines to
be appropriate.
(b) Coordinating Committee
(1) In general
The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the ‘‘Coordinating
Committee’’) coordinates activities across the
National Institutes and with other Federal
health programs and activities relating to
such diseases.
(2) Composition
The Coordinating Committee shall be composed of the directors or their designees of
each of the national research institutes involved in research with respect to autoimmune diseases and representatives of all
other Federal departments and agencies whose
programs involve health functions or responsibilities relevant to such diseases, including
the Centers for Disease Control and Prevention and the Food and Drug Administration.
(3) Chair
(A) In general
With respect to autoimmune diseases, the
Chair of the Committee shall serve as the
principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the
Director of the Centers for Disease Control
and Prevention, the Commissioner of Food
and Drugs, and other relevant agencies.
(B) Director of NIH
The Chair of the Committee shall be directly responsible to the Director of NIH.
(c) Plan for NIH activities
(1) In general
Not later than 1 year after October 17, 2000,
the Coordinating Committee shall develop a
plan for conducting and supporting research
and education on autoimmune diseases
1 So

in original. Probably should be ‘‘pathogenesis’’.

§ 284j

TITLE 42—THE PUBLIC HEALTH AND WELFARE

through the national research institutes and
shall periodically review and revise the plan.
The plan shall—
(A) provide for a broad range of research
and education activities relating to biomedical, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases on women;
(B) identify priorities among the programs
and activities of the National Institutes of
Health regarding such diseases; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan
The plan under paragraph (1) shall, with respect to autoimmune diseases, provide for the
following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of the
diseases.
(B) Basic research concerning the etiology
and causes of the diseases.
(C) Epidemiological studies to address the
frequency and natural history of the diseases, including any differences among the
sexes and among racial and ethnic groups.
(D) The development of improved screening techniques.
(E) Clinical research for the development
and evaluation of new treatments, including
new biological agents.
(F) Information and education programs
for health care professionals and the public.
(3) Implementation of plan
The Director of NIH shall ensure that programs and activities of the National Institutes
of Health regarding autoimmune diseases are
implemented in accordance with the plan
under paragraph (1).

Page 526

ceding sentence is in addition to any other authorization of appropriations that is available for conducting
or supporting through the National Institutes of Health
research and other activities with respect to autoimmune diseases.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 284j. Muscular dystrophy research
(a) Coordination of activities
The Director of NIH shall expand and increase
coordination in the activities of the National Institutes of Health with respect to research on
muscular dystrophies, including Duchenne muscular dystrophy.
(b) Administration of program; collaboration
among agencies
The Director of NIH shall carry out this section through the appropriate institutes, including the National Institute of Neurological Disorders and Stroke and in collaboration with any
other agencies that the Director determines appropriate.
(July 1, 1944, ch. 373, title IV, § 409F, as added
Pub. L. 106–310, div. A, title XXII, § 2201, Oct. 17,
2000, 114 Stat. 1157; amended Pub. L. 109–482, title
I, § 103(b)(12), Jan. 15, 2007, 120 Stat. 3687.)
AMENDMENTS
2007—Subsec. (c). Pub. L. 109–482 struck out heading
and text of subsec. (c). Text read as follows: ‘‘There are
authorized to be appropriated such sums as may be necessary to carry out this section for each of the fiscal
years 2001 through 2005. Amounts appropriated under
this subsection shall be in addition to any other
amounts appropriated for such purpose.’’
EFFECTIVE DATE OF 2007 AMENDMENT

(July 1, 1944, ch. 373, title IV, § 409E, as added
Pub. L. 106–310, div. A, title XIX, § 1901, Oct. 17,
2000, 114 Stat. 1153; amended Pub. L. 109–482, title
I, §§ 103(b)(11), 104(b)(1)(E), Jan. 15, 2007, 120 Stat.
3687, 3693.)

Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

AMENDMENTS

(a) In general
The Director of National Institutes of Health
shall undertake activities to support and expand
the involvement of the National Institutes of
Health in clinical research.
(b) Requirements
In carrying out subsection (a) of this section,
the Director of National Institutes of Health
shall—
(1) consider the recommendations of the Division of Research Grants Clinical Research
Study Group and other recommendations for
enhancing clinical research; and
(2) establish intramural and extramural clinical research fellowship programs directed specifically at medical and dental students and a
continuing education clinical research training program at the National Institutes of
Health.
(c) Support for the diverse needs of clinical research
The Director of National Institutes of Health,
in cooperation with the Directors of the Insti-

2007—Subsec. (d). Pub. L. 109–482, § 104(b)(1)(E), struck
out heading and text of subsec. (d). Text read as follows: ‘‘The Coordinating Committee under subsection
(b)(1) of this section shall biennially submit to the
Committee on Commerce of the House of Representatives, and the Committee on Health, Education, Labor
and Pensions of the Senate, a report that describes the
research, education, and other activities on autoimmune diseases being conducted or supported through
the national research institutes, and that in addition
includes the following:
‘‘(1) The plan under subsection (c)(1) of this section
(or revisions to the plan, as the case may be).
‘‘(2) Provisions specifying the amounts expended by
the National Institutes of Health with respect to each
of the autoimmune diseases included in the plan.
‘‘(3) Provisions identifying particular projects or
types of projects that should in the future be considered by the national research institutes or other entities in the field of research on autoimmune diseases.’’
Subsec. (e). Pub. L. 109–482, § 103(b)(11), struck out
heading and text of subsec. (e). Text read as follows:
‘‘For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. The
authorization of appropriations established in the pre-

§ 284k. Clinical research

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

tutes, Centers, and Divisions of the National Institutes of Health, shall support and expand the
resources available for the diverse needs of the
clinical research community, including inpatient, outpatient, and critical care clinical research.
(d) Peer review
The Director of National Institutes of Health
shall establish peer review mechanisms to evaluate applications for the awards and fellowships
provided for in subsection (b)(2) of this section
and section 284l of this title. Such review mechanisms shall include individuals who are exceptionally qualified to appraise the merits of potential clinical research training and research
grant proposals.
(July 1, 1944, ch. 373, title IV, § 409G, formerly
§ 409C, as added Pub. L. 106–505, title II, § 203,
Nov. 13, 2000, 114 Stat. 2326; renumbered § 409G,
Pub. L. 107–109, § 3(1), Jan. 4, 2002, 115 Stat. 1408.)
REFERENCES IN TEXT
Section 284l of this title, referred to in subsec. (d),
was in the original ‘‘section 409D’’, and was translated
as meaning section 409D of act July 1, 1944, ch. 373, as
added by section 204(b) of Pub. L. 106–505. Such section
409D was renumbered section 409H of act July 1, 1944,
ch. 373, by Pub. L. 107–109, § 3(2), Jan. 4, 2002, 115 Stat.
1408. Another section 409D of act July 1, 1944, ch. 373, as
added by section 1001 of Pub. L. 106–310, is classified to
section 284h of this title.
FINDINGS AND PURPOSE
Pub. L. 106–505, title II, § 202, Nov. 13, 2000, 114 Stat.
2325, provided that:
‘‘(a) FINDINGS.—Congress makes the following findings:
‘‘(1) Clinical research is critical to the advancement
of scientific knowledge and to the development of
cures and improved treatment for disease.
‘‘(2) Tremendous advances in biology are opening
doors to new insights into human physiology,
pathophysiology and disease, creating extraordinary
opportunities for clinical research.
‘‘(3) Clinical research includes translational research which is an integral part of the research process leading to general human applications. It is the
bridge between the laboratory and new methods of diagnosis, treatment, and prevention and is thus essential to progress against cancer and other diseases.
‘‘(4) The United States will spend more than
$1,200,000,000,000 on health care in 1999, but the Federal budget for health research at the National Institutes of Health was $15,600,000,000 only 1 percent of
that total.
‘‘(5) Studies at the Institute of Medicine, the National Research Council, and the National Academy
of Sciences have all addressed the current problems
in clinical research.
‘‘(6) The Director of the National Institutes of
Health has recognized the current problems in clinical research and appointed a special panel, which recommended expanded support for existing National Institutes of Health clinical research programs and the
creation of new initiatives to recruit and retain clinical investigators.
‘‘(7) The current level of training and support for
health professionals in clinical research is fragmented, undervalued, and underfunded.
‘‘(8) Young investigators are not only apprentices
for future positions but a crucial source of energy,
enthusiasm, and ideas in the day-to-day research that
constitutes the scientific enterprise. Serious questions about the future of life-science research are
raised by the following:
‘‘(A) The number of young investigators applying
for grants dropped by 54 percent between 1985 and
1993.

§ 284l

‘‘(B) The number of physicians applying for firsttime National Institutes of Health research project
grants fell from 1226 in 1994 to 963 in 1998, a 21 percent reduction.
‘‘(C) Newly independent life-scientists are expected to raise funds to support their new research
programs and a substantial proportion of their own
salaries.
‘‘(9) The following have been cited as reasons for
the decline in the number of active clinical researchers, and those choosing this career path:
‘‘(A) A medical school graduate incurs an average
debt of $85,619, as reported in the Medical School
Graduation Questionnaire by the Association of
American Medical Colleges (AAMC).
‘‘(B) The prolonged period of clinical training required increases the accumulated debt burden.
‘‘(C) The decreasing number of mentors and role
models.
‘‘(D) The perceived instability of funding from the
National Institutes of Health and other Federal
agencies.
‘‘(E) The almost complete absence of clinical research training in the curriculum of training grant
awardees.
‘‘(F) Academic Medical Centers are experiencing
difficulties in maintaining a proper environment
for research in a highly competitive health care
marketplace, which are compounded by the decreased willingness of third party payers to cover
health care costs for patients engaged in research
studies and research procedures.
‘‘(10) In 1960, general clinical research centers were
established under the Office of the Director of the National Institutes of Health with an initial appropriation of $3,000,000.
‘‘(11) Appropriations for general clinical research
centers in fiscal year 1999 equaled $200,500,000.
‘‘(12) Since the late 1960s, spending for general clinical research centers has declined from approximately
3 percent to 1 percent of the National Institutes of
Health budget.
‘‘(13) In fiscal year 1999, there were 77 general clinical research centers in operation, supplying patients
in the areas in which such centers operate with access to the most modern clinical research and clinical
research facilities and technologies.
‘‘(b) PURPOSE.—It is the purpose of this title [see
Short Title of 2000 Amendments note set out under section 201 of this title] to provide additional support for
and to expand clinical research programs.’’
OVERSIGHT BY GAO
Pub. L. 106–505, title II, § 207, Nov. 13, 2000, 114 Stat.
2330, provided that, not later than 18 months after Nov.
13, 2000, the Comptroller General was to submit to Congress a report describing the extent to which the National Institutes of Health had complied with the
amendments made by title II of Pub. L. 106–505.

§ 284l. Enhancement awards
(a) Mentored Patient-Oriented Research Career
Development Awards
(1) Grants
(A) In general
The Director of the National Institutes of
Health shall make grants (to be referred to
as ‘‘Mentored Patient-Oriented Research Career Development Awards’’) to support individual careers in clinical research at general
clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting
patient-oriented clinical research.
(B) Use
Grants under subparagraph (A) shall be
used to support clinical investigators in the

§ 284m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

early phases of their independent careers by
providing salary and such other support for
a period of supervised study.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(b) Mid-Career Investigator Awards in PatientOriented Research
(1) Grants
(A) In general
The Director of the National Institutes of
Health shall make grants (to be referred to
as ‘‘Mid-Career Investigator Awards in Patient-Oriented Research’’) to support individual clinical research projects at general
clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting
patient-oriented clinical research.
(B) Use
Grants under subparagraph (A) shall be
used to provide support for mid-career level
clinicians to allow such clinicians to devote
time to clinical research and to act as mentors for beginning clinical investigators.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual
scientist at such time as the Director requires.
(c) Graduate Training in Clinical Investigation
Award
(1) In general
The Director of the National Institutes of
Health shall make grants (to be referred to as
‘‘Graduate Training in Clinical Investigation
Awards’’) to support individuals pursuing master’s or doctoral degrees in clinical investigation.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(3) Limitations
Grants under this subsection shall be for
terms of 2 years or more and shall provide stipend, tuition, and institutional support for individual advanced degree programs in clinical
investigation.
(4) Definition
As used in this subsection, the term ‘‘advanced degree programs in clinical investigation’’ means programs that award a master’s
or Ph.D. degree in clinical investigation after
2 or more years of training in areas such as
the following:
(A) Analytical methods, biostatistics, and
study design.
(B) Principles of clinical pharmacology
and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.

Page 528

(E) Ethical and regulatory issues.
(F) Biomedical writing.
(d) Clinical Research Curriculum Awards
(1) In general
The Director of the National Institutes of
Health shall make grants (to be referred to as
‘‘Clinical Research Curriculum Awards’’) to
institutions for the development and support
of programs of core curricula for training clinical investigators, including medical students.
Such core curricula may include training in
areas such as the following:
(A) Analytical methods, biostatistics, and
study design.
(B) Principles of clinical pharmacology
and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual institution or a consortium of institutions at
such time as the Director may require. An institution may submit only one such application.
(3) Limitations
Grants under this subsection shall be for
terms of up to 5 years and may be renewable.
(July 1, 1944, ch. 373, title IV, § 409H, formerly
§ 409D, as added Pub. L. 106–505, title II, § 204(b),
Nov. 13, 2000, 114 Stat. 2327; renumbered § 409H,
Pub. L. 107–109, § 3(2), Jan. 4, 2002, 115 Stat. 1408;
Pub. L. 109–482, title I, § 103(b)(13), Jan. 15, 2007,
120 Stat. 3687.)
AMENDMENTS
2007—Subsec. (a)(3). Pub. L. 109–482, § 103(b)(13)(A),
struck out heading and text of par. (3). Text read as follows: ‘‘For the purpose of carrying out this subsection,
there are authorized to be appropriated such sums as
may be necessary for each fiscal year.’’
Subsec. (b)(3). Pub. L. 109–482, § 103(b)(13)(B), struck
out heading and text of par. (3). Text read as follows:
‘‘For the purpose of carrying out this subsection, there
are authorized to be appropriated such sums as may be
necessary for each fiscal year.’’
Subsec. (c)(5). Pub. L. 109–482, § 103(b)(13)(C), struck
out heading and text of par. (5). Text read as follows:
‘‘For the purpose of carrying out this subsection, there
are authorized to be appropriated such sums as may be
necessary for each fiscal year.’’
Subsec. (d)(4). Pub. L. 109–482, § 103(b)(13)(D), struck
out heading and text of par. (4). Text read as follows:
‘‘For the purpose of carrying out this subsection, there
are authorized to be appropriated such sums as may be
necessary for each fiscal year.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 284m. Program for pediatric studies of drugs
(a) List of priority issues in pediatric therapeutics
(1) In general
Not later than one year after September 27,
2007, the Secretary, acting through the Direc-

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tor of the National Institutes of Health and in
consultation with the Commissioner of Food
and Drugs and experts in pediatric research,
shall develop and publish a priority list of
needs in pediatric therapeutics, including
drugs, biological products, or indications that
require study. The list shall be revised every
three years.
(2) Consideration of available information
In developing and prioritizing the list under
paragraph (1), the Secretary shall consider—
(A) therapeutic gaps in pediatrics that
may include developmental pharmacology,
pharmacogenetic determinants of drug response, metabolism of drugs and biologics in
children, and pediatric clinical trials;
(B) particular pediatric diseases, disorders
or conditions where more complete knowledge and testing of therapeutics, including
drugs and biologics, may be beneficial in pediatric populations; and
(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological
research, including research networks and
trained pediatric investigators.
(b) Pediatric studies and research
The Secretary, acting through the National
Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric
clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups,
federally funded programs such as pediatric
pharmacology research units, other public or
private institutions, or individuals) to enable
the entities to conduct the drug studies or other
research on the issues described in subsection
(a). The Secretary may use contracts, grants, or
other appropriate funding mechanisms to award
funds under this subsection.
(c) Process for proposed pediatric study requests
and labeling changes
(1) Submission of proposed pediatric study request
The Director of the National Institutes of
Health shall, as appropriate, submit proposed
pediatric study requests for consideration by
the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication
identified under subsection (a). Such a proposed pediatric study request shall be made in
a manner equivalent to a written request
made under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 355a], including with respect to
the information provided on the pediatric
studies to be conducted pursuant to the request. The Director of the National Institutes
of Health may submit a proposed pediatric
study request for a drug for which—
(A)(i) there is an approved application
under section 505(j) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)]; or
(ii) there is a submitted application that
could be approved under the criteria of such
section; and
(B) there is no patent protection or market
exclusivity protection for at least one form
of the drug under the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.]; and

§ 284m

(C) additional studies are needed to assess
the safety and effectiveness of the use of the
drug in the pediatric population.
(2) Written request to holders of approved applications for drugs lacking exclusivity
The Commissioner of Food and Drugs, in
consultation with the Director of the National
Institutes of Health, may issue a written request based on the proposed pediatric study
request for the indication or indications submitted pursuant to paragraph (1) (which shall
include a timeframe for negotiations for an
agreement) for pediatric studies concerning a
drug identified under subsection (a) to all
holders of an approved application for the drug
under section 505 of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 355]. Such a written request shall be made in a manner equivalent to the manner in which a written request
is made under subsection (b) or (c) of section
505A of such Act [21 U.S.C. 355a], including
with respect to information provided on the
pediatric studies to be conducted pursuant to
the request and using appropriate formulations for each age group for which the study is
requested.
(3) Requests for proposals
If the Commissioner of Food and Drugs does
not receive a response to a written request issued under paragraph (2) not later than 30 days
after the date on which a request was issued,
the Secretary, acting through the Director of
the National Institutes of Health and in consultation with the Commissioner of Food and
Drugs, shall publish a request for proposals to
conduct the pediatric studies described in the
written request in accordance with subsection
(b).
(4) Disqualification
A holder that receives a first right of refusal
shall not be entitled to respond to a request
for proposals under paragraph (3).
(5) Contracts, grants, or other funding mechanisms
A contract, grant, or other funding may be
awarded under this section only if a proposal
is submitted to the Secretary in such form and
manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(6) Reporting of studies
(A) In general
On completion of a pediatric study in accordance with an award under this section, a
report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of
Food and Drugs. The report shall include all
data generated in connection with the study,
including a written request if issued.
(B) Availability of reports
Each report submitted under subparagraph
(A) shall be considered to be in the public
domain (subject to section 505A(d)(4) of the
Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355a(d)(4)]) and shall be assigned a

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

docket number by the Commissioner of Food
and Drugs. An interested person may submit
written comments concerning such pediatric
studies to the Commissioner of Food and
Drugs, and the written comments shall become part of the docket file with respect to
each of the drugs.
(C) Action by Commissioner
The Commissioner of Food and Drugs shall
take appropriate action in response to the
reports submitted under subparagraph (A) in
accordance with paragraph (7).
(7) Requests for labeling change
During the 180-day period after the date on
which a report is submitted under paragraph
(6)(A), the Commissioner of Food and Drugs
shall—
(A) review the report and such other data
as are available concerning the safe and effective use in the pediatric population of the
drug studied;
(B) negotiate with the holders of approved
applications for the drug studied for any labeling changes that the Commissioner of
Food and Drugs determines to be appropriate and requests the holders to make; and
(C)(i) place in the public docket file a copy
of the report and of any requested labeling
changes; and
(ii) publish in the Federal Register and
through a posting on the Web site of the
Food and Drug Administration a summary
of the report and a copy of any requested labeling changes.
(8) Dispute resolution
(A) Referral to Pediatric Advisory Committee
If, not later than the end of the 180-day period specified in paragraph (7), the holder of
an approved application for the drug involved does not agree to any labeling change
requested by the Commissioner of Food and
Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.
(B) Action by the Pediatric Advisory Committee
Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric
Advisory Committee shall—
(i) review the available information on
the safe and effective use of the drug in
the pediatric population, including study
reports submitted under this section; and
(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
(9) FDA determination
Not later than 30 days after receiving a recommendation from the Pediatric Advisory
Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and
Drugs shall consider the recommendation and,
if appropriate, make a request to the holders
of approved applications for the drug to make
any labeling change that the Commissioner of
Food and Drugs determines to be appropriate.
(10) Failure to agree
If a holder of an approved application for a
drug, within 30 days after receiving a request

Page 530

to make a labeling change under paragraph
(9), does not agree to make a requested labeling change, the Commissioner of Food and
Drugs may deem the drug to be misbranded
under the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.].
(11) No effect on authority
Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.] when
a drug lacks appropriate pediatric labeling.
Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence)
shall preclude, delay, or serve as the basis to
stay the other course of action.
(d) Dissemination of pediatric information
Not later than one year after September 27,
2007, the Secretary, acting through the Director
of the National Institutes of Health, shall study
the feasibility of establishing a compilation of
information on pediatric drug use and report the
findings to Congress.
(e) Authorization of appropriations
(1) In general
There are authorized to be appropriated to
carry out this section—
(A) $200,000,000 for fiscal year 2008; and
(B) such sums as are necessary for each of
the four succeeding fiscal years.
(2) Availability
Any amount appropriated under paragraph
(1) shall remain available to carry out this
section until expended.
(July 1, 1944, ch. 373, title IV, § 409I, as added
Pub. L. 107–109, § 3(3), Jan. 4, 2002, 115 Stat. 1408;
amended Pub. L. 108–155, § 3(b)(6), Dec. 3, 2003, 117
Stat. 1942; Pub. L. 109–482, title I, § 103(b)(14),
Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–85, title
V, § 502(b), Sept. 27, 2007, 121 Stat. 886; Pub. L.
111–148, title VII, § 7002(g)(2)(A), Mar. 23, 2010, 124
Stat. 820.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(1)(B), (10), (11), is act June 25, 1938, ch.
675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section
301 of Title 21 and Tables.
AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–148 inserted
‘‘, biological products,’’ after ‘‘including drugs’’.
2007—Pub. L. 110–85 amended section generally. Prior
to amendment, section related to development of list of
drugs for which pediatric studies are needed, award of
contracts for pediatric studies, process for requesting
contract proposals to conduct certain pediatric studies,
reporting of completed studies, requests for labeling
changes and dispute resolution, and recommendation
by the Secretary for formulation changes.
Subsec. (d). Pub. L. 109–482 struck out subsec. (d)
which related to authorization and availability of appropriations.
2003—Subsec. (c)(8), (9), (11). Pub. L. 108–155 struck out
‘‘Advisory Subcommittee of the Anti-Infective Drugs’’
before ‘‘Advisory Committee’’ wherever appearing.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or

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subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–155 effective Dec. 3, 2003,
except as otherwise provided, see section 4 of Pub. L.
108–155, set out as an Effective Date note under section
355c of Title 21, Food and Drugs.
PEDIATRIC ADVISORY COMMITTEE
Pub. L. 107–109, § 14, Jan. 4, 2002, 115 Stat. 1419, as
amended by Pub. L. 108–155, § 3(b)(2), Dec. 3, 2003, 117
Stat. 1941; Pub. L. 110–85, title III, § 306(b), title V,
§ 502(d), Sept. 27, 2007, 121 Stat. 865, 889, provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services shall, under section 222 of the Public
Health Service Act (42 U.S.C. 217a) or other appropriate
authority, convene and consult an advisory committee
on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this
section as the ‘advisory committee’).
‘‘(b) PURPOSE.—
‘‘(1) IN GENERAL.—The advisory committee shall advise and make recommendations to the Secretary,
through the Commissioner of Food and Drugs, on
matters relating to pediatric therapeutics (including
drugs and biological products) and medical devices.
‘‘(2) MATTERS INCLUDED.—The matters referred to in
paragraph (1) include—
‘‘(A) pediatric research conducted under sections
351, 409I, and 499 of the Public Health Service Act
[42 U.S.C. 262, 284m, and 290b] and sections 501, 502,
505, 505A, 505B, 510(k), 515, and 520(m) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 351, 352,
355, 355a, 355c, 360(k), 360e, and 360j(m)];
‘‘(B) identification of research priorities related
to therapeutics (including drugs and biological
products) and medical devices for pediatric populations and the need for additional diagnostics and
treatments for specific pediatric diseases or conditions; [and]
‘‘(C) the ethics, design, and analysis of clinical
trials related to pediatric therapeutics (including
drugs and biological products) and medical devices.
‘‘(c) COMPOSITION.—The advisory committee shall include representatives of pediatric health organizations,
pediatric researchers, relevant patient and patientfamily organizations, and other experts selected by the
Secretary.
‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.—
Notwithstanding section 14 of the Federal Advisory
Committee Act [5 U.S.C. App.], the advisory committee
shall continue to operate during the five-year period
beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007 [Sept. 27,
2007].’’

§ 284n. Certain demonstration projects
(a) Bridging the sciences
(1) In general
From amounts to be appropriated under section 282a(b) of this title, the Secretary of
Health and Human Services, acting through
the Director of NIH, (in this subsection referred to as the ‘‘Secretary’’) in consultation
with the Director of the National Science
Foundation, the Secretary of Energy, and
other agency heads when necessary, may allocate funds for the national research institutes
and national centers to make grants for the
purpose of improving the public health
through demonstration projects for biomedical
research at the interface between the biological, behavioral, and social sciences and the
physical, chemical, mathematical, and computational sciences.

§ 284n

(2) Goals, priorities, and methods; interagency
collaboration
The Secretary shall establish goals, priorities, and methods of evaluation for research
under paragraph (1), and shall provide for
interagency collaboration with respect to such
research. In developing such goals, priorities,
and methods, the Secretary shall ensure
that—
(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum
of projects, funded at various levels, with
varying timeframes.
(3) Peer review
A grant may be made under paragraph (1)
only if the application for the grant has undergone technical and scientific peer review
under section 289a of this title and has been reviewed by the advisory council under section
282(k) of this title or has been reviewed by an
advisory council composed of representatives
from appropriate scientific disciplines who can
fully evaluate the applicant.
(b) High-risk, high-reward research
(1) In general
From amounts to be appropriated under section 282a(b) of this title, the Secretary, acting
through the Director of NIH, may allocate
funds for the national research institutes and
national centers to make awards of grants or
contracts or to engage in other transactions
for demonstration projects for high-impact,
cutting-edge research that fosters scientific
creativity and increases fundamental biological understanding leading to the prevention,
diagnosis, and treatment of diseases and disorders. The head of a national research institute or national center may conduct or support such high-impact, cutting-edge research
(with funds allocated under the preceding sentence or otherwise available for such purpose)
if the institute or center gives notice to the
Director of NIH beforehand and submits a report to the Director of NIH on an annual basis
on the activities of the institute or center relating to such research.
(2) Special consideration
In carrying out the program under paragraph (1), the Director of NIH shall give special consideration to coordinating activities
with national research institutes whose budgets are substantial relative to a majority of
the other institutes.
(3) Administration of program
Activities relating to research described in
paragraph (1) shall be designed by the Director
of NIH or the head of a national research institute or national center, as applicable, to enable such research to be carried out with maximum flexibility and speed.
(4) Public-private partnerships
In providing for research described in paragraph (1), the Director of NIH or the head of a
national research institute or national center,
as applicable, shall seek to facilitate partner-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ships between public and private entities and
shall coordinate when appropriate with the
Foundation for the National Institutes of
Health.
(5) Peer review
A grant for research described in paragraph
(1) may be made only if the application for the
grant has undergone technical and scientific
peer review under section 289a of this title and
has been reviewed by the advisory council
under section 282(k) of this title.
(c) Report to Congress
Not later than the end of fiscal year 2009, the
Secretary, acting through the Director of NIH,
shall conduct an evaluation of the activities
under this section and submit a report to the
Congress on the results of such evaluation.
(d) Definitions
For purposes of this section, the terms ‘‘Director of NIH’’, ‘‘national research institute’’, and
‘‘national center’’ have the meanings given such
terms in section 281 of this title.
(Pub. L. 109–482, title I, § 105, Jan. 15, 2007, 120
Stat. 3694.)
CODIFICATION
Section was enacted as part of the National Institutes of Health Reform Act of 2006, and not as part of
the Public Health Service Act which comprises this
chapter.
EFFECTIVE DATE
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 284o. Activities of the National Institutes of
Health with respect to research on paralysis
(a) Coordination
The Director of the National Institutes of
Health (referred to in this section and sections
280g–9 and 284p of this title as the ‘‘Director’’),
pursuant to the general authority of the Director, may develop mechanisms to coordinate the
paralysis research and rehabilitation activities
of the Institutes and Centers of the National Institutes of Health in order to further advance
such activities and avoid duplication of activities.
(b) Christopher and Dana Reeve Paralysis Research Consortia
(1) In general
The Director may make awards of grants to
public or private entities to pay all or part of
the cost of planning, establishing, improving,
and providing basic operating support for consortia in paralysis research. The Director shall
designate each consortium funded through
such grants as a Christopher and Dana Reeve
Paralysis Research Consortium.
(2) Research
Each consortium under paragraph (1)—
(A) may conduct basic, translational, and
clinical paralysis research;
(B) may focus on advancing treatments
and developing therapies in paralysis research;

Page 532

(C) may focus on one or more forms of paralysis that result from central nervous system trauma or stroke;
(D) may facilitate and enhance the dissemination of clinical and scientific findings; and
(E) may replicate the findings of consortia
members or other researchers for scientific
and translational purposes.
(3) Coordination of consortia; reports
The Director may, as appropriate, provide
for the coordination of information among
consortia under paragraph (1) and ensure regular communication among members of the
consortia, and may require the periodic preparation of reports on the activities of the consortia and the submission of the reports to the
Director.
(4) Organization of consortia
Each consortium under paragraph (1) may
use the facilities of a single lead institution,
or be formed from several cooperating institutions, meeting such requirements as may be
prescribed by the Director.
(c) Public input
The Director may provide for a mechanism to
educate and disseminate information on the existing and planned programs and research activities of the National Institutes of Health with
respect to paralysis and through which the Director can receive comments from the public regarding such programs and activities.
(Pub. L. 111–11, title XIV, § 14101, Mar. 30, 2009,
123 Stat. 1452.)
CODIFICATION
Section was enacted as part of the Christopher and
Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as
part of the Public Health Service Act which comprises
this chapter.

§ 284p. Activities of the National Institutes of
Health with respect to research with implications for enhancing daily function for persons with paralysis
(a) In general
The Director, pursuant to the general authority of the Director, may make awards of grants
to public or private entities to pay all or part of
the costs of planning, establishing, improving,
and providing basic operating support to multicenter networks of clinical sites that will collaborate to design clinical rehabilitation intervention protocols and measures of outcomes on
one or more forms of paralysis that result from
central nervous system trauma, disorders, or
stroke, or any combination of such conditions.
(b) Research
A multicenter network of clinical sites funded
through this section may—
(1) focus on areas of key scientific concern,
including—
(A) improving functional mobility;
(B) promoting behavioral adaptation to
functional losses, especially to prevent secondary complications;
(C) assessing the efficacy and outcomes of
medical rehabilitation therapies and practices and assisting technologies;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) developing improved assistive technology to improve function and independence; and
(E) understanding whole body system responses to physical impairments, disabilities, and societal and functional limitations; and
(2) replicate the findings of network members or other researchers for scientific and
translation purposes.
(c) Coordination of clinical trials networks; reports
The Director may, as appropriate, provide for
the coordination of information among networks funded through this section and ensure
regular communication among members of the
networks, and may require the periodic preparation of reports on the activities of the networks
and submission of reports to the Director.
(Pub. L. 111–11, title XIV, § 14201, Mar. 30, 2009,
123 Stat. 1453.)
CODIFICATION
Section was enacted as part of the Christopher and
Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as
part of the Public Health Service Act which comprises
this chapter.
DEFINITION OF ‘‘DIRECTOR’’
‘‘Director’’ as meaning the Director of the National
Institutes of Health, see section 284o(a) of this title.

§ 284q. Pain research
(a) Research initiatives
(1) In general
The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential
treatments for pain.
(2) Annual recommendations
Not less than annually, the Pain Consortium, in consultation with the Division of Program Coordination, Planning, and Strategic
Initiatives, shall develop and submit to the Director of NIH recommendations on appropriate
pain research initiatives that could be undertaken with funds reserved under section
282a(c)(1) of this title for the Common Fund or
otherwise available for such initiatives.
(3) Definition
In this subsection, the term ‘‘Pain Consortium’’ means the Pain Consortium of the National Institutes of Health or a similar transNational Institutes of Health coordinating entity designated by the Secretary for purposes
of this subsection.
(b) Interagency Pain Research Coordinating
Committee
(1) Establishment
The Secretary shall establish not later than
1 year after March 23, 2010, and as necessary
maintain a committee, to be known as the
Interagency Pain Research Coordinating Committee (in this section referred to as the
‘‘Committee’’), to coordinate all efforts within

§ 284q

the Department of Health and Human Services
and other Federal agencies that relate to pain
research.
(2) Membership
(A) In general
The Committee shall be composed of the
following voting members:
(i) Not more than 7 voting Federal representatives appoint 1 by the Secretary
from agencies that conduct pain care research and treatment.
(ii) 12 additional voting members appointed under subparagraph (B).
(B) Additional members
The Committee shall include additional
voting members appointed by the Secretary
as follows:
(i) 6 non-Federal members shall be appointed from among scientists, physicians,
and other health professionals.
(ii) 6 members shall be appointed from
members of the general public, who are
representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.
(C) Nonvoting members
The Committee shall include such nonvoting members as the Secretary determines
to be appropriate.
(3) Chairperson
The voting members of the Committee shall
select a chairperson from among such members. The selection of a chairperson shall be
subject to the approval of the Director of NIH.
(4) Meetings
The Committee shall meet at the call of the
chairperson of the Committee or upon the request of the Director of NIH, but in no case
less often than once each year.
(5) Duties
The Committee shall—
(A) develop a summary of advances in pain
care research supported or conducted by the
Federal agencies relevant to the diagnosis,
prevention, and treatment of pain and diseases and disorders associated with pain;
(B) identify critical gaps in basic and clinical research on the symptoms and causes of
pain;
(C) make recommendations to ensure that
the activities of the National Institutes of
Health and other Federal agencies are free of
unnecessary duplication of effort;
(D) make recommendations on how best to
disseminate information on pain care; and
(E) make recommendations on how to expand partnerships between public entities
and private entities to expand collaborative,
cross-cutting research.
(6) Review
The Secretary shall review the necessity of
the Committee at least once every 2 years.
(July 1, 1944, ch. 373, title IV, § 409J, as added
Pub. L. 111–148, title IV, § 4305(b), Mar. 23, 2010,
124 Stat. 585.)
1 So

in original. Probably should be ‘‘appointed’’.

§ 285

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART C—SPECIFIC PROVISIONS RESPECTING
NATIONAL RESEARCH INSTITUTES
SUBPART 1—NATIONAL CANCER INSTITUTE

§ 285. Purpose of Institute
The general purpose of the National Cancer Institute (hereafter in this subpart referred to as
the ‘‘Institute’’) is the conduct and support of
research, training, health information dissemination, and other programs with respect to the
cause, diagnosis, prevention, and treatment of
cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families
of cancer patients.
(July 1, 1944, ch. 373, title IV, § 410, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 832; amended
Pub. L. 100–607, title I, § 121, Nov. 4, 1988, 102
Stat. 3054.)
AMENDMENTS
1988—Pub. L. 100–607 inserted ‘‘, rehabilitation from
cancer,’’ after ‘‘treatment of cancer’’.

§ 285a. National Cancer Program
The National Cancer Program shall consist of
(1) an expanded, intensified, and coordinated
cancer research program encompassing the research programs conducted and supported by the
Institute and the related research programs of
the other national research institutes, including
an expanded and intensified research program
for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities
of the Institute.
(July 1, 1944, ch. 373, title IV, § 411, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 832.)
§ 285a–1. Cancer control programs
The Director of the Institute shall establish
and support demonstration, education, and
other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include—
(1) locally initiated education and demonstration programs (and regional networks of
such programs) to transmit research results
and to disseminate information respecting—
(A) the detection, diagnosis, prevention,
and treatment of cancer,
(B) the continuing care of cancer patients
and the families of cancer patients, and
(C) rehabilitation and counseling respecting cancer,
to physicians and other health professionals
who provide care to individuals who have cancer;
(2) the demonstration of and the education
of students of the health professions and
health professionals in—
(A) effective methods for the prevention
and early detection of cancer and the identification of individuals with a high risk of developing cancer, and
(B) improved methods of patient referral
to appropriate centers for early diagnosis
and treatment of cancer; and

Page 534

(3) the demonstration of new methods for the
dissemination of information to the general
public concerning the prevention, early detection, diagnosis, and treatment and control of
cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment,
and control of cancer.
(July 1, 1944, ch. 373, title IV, § 412, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 832.)
§ 285a–2. Special authorities of Director
(a) Information and education program
(1) The Director of the Institute shall establish an information and education program to
collect, identify, analyze, and disseminate on a
timely basis, through publications and other appropriate means, to cancer patients and their
families, physicians and other health professionals, and the general public, information on
cancer research, diagnosis, prevention, and
treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The
Director of the Institute may take such action
as may be necessary to insure that all channels
for the dissemination and exchange of scientific
knowledge and information are maintained between the Institute and the public and between
the Institute and other scientific, medical, and
biomedical disciplines and organizations nationally and internationally.
(2) In carrying out paragraph (1), the Director
of the Institute shall—
(A) provide public and patient information
and education programs, providing information that will help individuals take personal
steps to reduce their risk of cancer, to make
them aware of early detection techniques and
to motivate appropriate utilization of those
techniques, to help individuals deal with cancer if it strikes, and to provide information to
improve long-term survival;
(B) continue and expand programs to provide
physicians and the public with state-of-the-art
information on the treatment of particular
forms of cancers, and to identify those clinical
trials that might benefit patients while advancing knowledge of cancer treatment;
(C) assess the incorporation of state-of-theart cancer treatments into clinical practice
and the extent to which cancer patients receive such treatments and include the results
of such assessments in the biennial reports required under section 284b 1 of this title;
(D) maintain and operate the International
Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as
feasible the results of cancer research and
treatment undertaken in any country for the
use of any person involved in cancer research
and treatment in any country; and
(E) to the extent practicable, in disseminating the results of such cancer research and
treatment, utilize information systems available to the public.
(b) National Cancer Program
The Director of the Institute in carrying out
the National Cancer Program—
1 See

References in Text note below.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) shall establish or support the large-scale
production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards
of safety and care for persons using such materials;
(2) shall, in consultation with the advisory
council for the Institute, support (A) research
in the cancer field outside the United States
by highly qualified foreign nationals which
can be expected to benefit the American people, (B) collaborative research involving
American and foreign participants, and (C) the
training of American scientists abroad and
foreign scientists in the United States;
(3) shall, in consultation with the advisory
council for the Institute, support appropriate
programs of education and training (including
continuing education and laboratory and clinical research training);
(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such
research;
(5) may obtain (after consultation with the
advisory council for the Institute and in accordance with section 3109 of title 5, but without regard to the limitation in such section on
the period of service) the services of not more
than one hundred and fifty-one experts or consultants who have scientific or professional
qualifications;
(6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve, repair, operate, and maintain
laboratories, other research facilities, equipment, and such other real or personal property
as the Director determines necessary;
(B) may, in consultation with the advisory
council for the Institute, make grants for construction or renovation of facilities; and
(C) may, in consultation with the advisory
council for the Institute, acquire, without regard to section 8141 of title 40, by lease or
otherwise through the Administrator of General Services, buildings or parts of buildings in
the District of Columbia or communities located adjacent to the District of Columbia for
the use of the Institute for a period not to exceed ten years;
(7) may, in consultation with the advisory
council for the Institute, appoint one or more
advisory committees composed of such private
citizens and officials of Federal, State, and
local governments to advise the Director with
respect to the Director’s functions;
(8) may, subject to section 284(b)(2) of this
title and without regard to section 3324 of title
31 and section 6101 of title 41, enter into such
contracts, leases, cooperative agreements, as
may be necessary in the conduct of functions
of the Director, with any public agency, or
with any person, firm, association, corporation, or educational institution; and
(9) shall, notwithstanding section 284(a) of
this title, prepare and submit, directly to the
President for review and transmittal to Congress, an annual budget estimate (including an
estimate of the number and type of personnel
needs for the Institute) for the National Cancer Program, after reasonable opportunity for

§ 285a–2

comment (but without change) by the Secretary, the Director of NIH, and the Institute’s
advisory council.
Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5 for their travel to and from
their place of service and for other expenses associated with their assignment. Such expenses
shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the
expert or consultant has agreed in writing to
complete the entire period of the assignment or
one year of the assignment, whichever is shorter, unless separated or reassigned for reasons
which are beyond the control of the expert or
consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by
the United States for such expenses is recoverable from the expert or consultant as a debt due
the United States. The Secretary may waive in
whole or in part a right of recovery under the
preceding sentence.
(c) Pre-clinical models to evaluate promising pediatric cancer therapies
(1) Expansion and coordination of activities
The Director of the National Cancer Institute shall expand, intensify, and coordinate
the activities of the Institute with respect to
research on the development of preclinical
models to evaluate which therapies are likely
to be effective for treating pediatric cancer.
(2) Coordination with other institutes
The Director of the Institute shall coordinate the activities under paragraph (1) with
similar activities conducted by other national
research institutes and agencies of the National Institutes of Health to the extent that
those Institutes and agencies have responsibilities that are related to pediatric cancer.
(July 1, 1944, ch. 373, title IV, § 413, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 833; amended
Pub. L. 100–607, title I, § 122, Nov. 4, 1988, 102
Stat. 3054; Pub. L. 101–93, § 5(c), Aug. 16, 1989, 103
Stat. 611; Pub. L. 103–43, title III, § 301(a)(2), June
10, 1993, 107 Stat. 150; Pub. L. 107–109, § 15(b), Jan.
4, 2002, 115 Stat. 1420.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec.
(a)(2)(C), was repealed by Pub. L. 109–482, title I,
§ 104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.
CODIFICATION
In subsec. (b)(6)(C), ‘‘section 8141 of title 40’’ substituted for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on
authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116
Stat. 1303, the first section of which enacted Title 40,
Public Buildings, Property, and Works.
In subsec. (b)(8), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
2002—Subsec. (c). Pub. L. 107–109 added subsec. (c).
1993—Subsec. (b)(9). Pub. L. 103–43 struck out subpar.
(A) designation and subpar. (B) which permitted Direc-

§ 285a–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tor to receive from President and Office of Management
and Budget directly all funds appropriated by Congress
for obligation and expenditure by Institute.
1989—Subsec. (a)(1). Pub. L. 101–93 substituted ‘‘Institute and’’ for ‘‘Institute and and’’.
1988—Subsec. (a). Pub. L. 100–607, § 122(1), designated
existing provisions as par. (1), substituted ‘‘education
program’’ for ‘‘education center’’, inserted ‘‘and the
public and between the Institute and’’ after ‘‘between
the Institute’’, and added par. (2).
Subsec. (b)(5). Pub. L. 100–607, § 122(2)(A), substituted
‘‘after consultation with’’ for ‘‘with the approval of’’.
Subsec. (b)(8) to (10). Pub. L. 100–607, § 122(2)(B), inserted ‘‘and’’ after ‘‘or educational institution;’’ in par.
(8), redesignated par. (10) as (9), and struck out former
par. (9) which related to International Cancer Research
Data Bank.

§ 285a–3. National cancer research and demonstration centers
(a) Cooperative agreements and grants for establishing and supporting
(1) The Director of the Institute may enter
into cooperative agreements with and make
grants to public or private nonprofit entities to
pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical
research into, training in, and demonstration of
advanced diagnostic, prevention, control, and
treatment methods for cancer.
(2) A cooperative agreement or grant under
paragraph (1) shall be entered into in accordance
with policies established by the Director of NIH
and after consultation with the Institute’s advisory council.
(b) Uses for Federal payments under cooperative
agreements or grants
Federal payments made under a cooperative
agreement or grant under subsection (a) of this
section may be used for—
(1) construction (notwithstanding any limitation under section 289e of this title);
(2) staffing and other basic operating costs,
including such patient care costs as are required for research;
(3) clinical training, including training for
allied health professionals, continuing education for health professionals and allied
health professions personnel, and information
programs for the public respecting cancer; and
(4) demonstration purposes.
As used in this paragraph, the term ‘‘construction’’ does not include the acquisition of land,
and the term ‘‘training’’ does not include research training for which Ruth L. Kirschstein
National Research Service Awards may be provided under section 288 of this title.
(c) Period of support; additional periods
Support of a center under subsection (a) of
this section may be for a period of not to exceed
five years. Such period may be extended by the
Director for additional periods of not more than
five years each if the operations of such center
have been reviewed by an appropriate technical
and scientific peer review group established by
the Director and if such group has recommended
to the Director that such period should be extended.

Page 536

(d) Construction
Research centers under this section may not
be considered centers of excellence for purposes
of section 282(b)(10) of this title.
(July 1, 1944, ch. 373, title IV, § 414, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 835; amended
Pub. L. 100–607, title I, § 123, Nov. 4, 1988, 102
Stat. 3055; Pub. L. 107–206, title I, § 804(c), Aug. 2,
2002, 116 Stat. 874; Pub. L. 109–482, title I, § 108(b),
Jan. 15, 2007, 120 Stat. 3697.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 added subsec. (d).
2002—Subsec. (b). Pub. L. 107–206 substituted ‘‘Ruth L.
Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’ in concluding provisions.
1988—Subsec. (a)(1). Pub. L. 100–607 inserted ‘‘control,’’ after ‘‘prevention,’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285a–4. President’s Cancer Panel; establishment, membership, etc., functions
(a)(1) The President’s Cancer Panel (hereafter
in this section referred to as the ‘‘Panel’’) shall
be composed of three persons appointed by the
President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program.
At least two members of the Panel shall be distinguished scientists or physicians.
(2)(A) Members of the Panel shall be appointed
for three-year terms, except that (i) any member
appointed to fill a vacancy occurring prior to
the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of such term, and
(ii) a member may serve until the member’s successor has taken office. If a vacancy occurs in
the Panel, the President shall make an appointment to fill the vacancy not later than 90 days
after the date the vacancy occurred.
(B) The President shall designate one of the
members to serve as the chairman of the Panel
for a term of one year.
(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18
of the General Schedule for each day (including
traveltime) during which they are engaged in
the actual performance of duties as members of
the Panel and shall be paid or reimbursed, in accordance with title 5, for their travel to and
from their place of service and for other expenses associated with their assignment.
(3) The Panel shall meet at the call of the
chairman, but not less often than four times a
year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the
public.
(b) The Panel shall monitor the development
and execution of the activities of the National
Cancer Program, and shall report directly to the
President. Any delays or blockages in rapid execution of the Program shall immediately be

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

brought to the attention of the President. The
Panel shall submit to the President periodic
progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of
the efficacy of the Program and suggestions for
improvements, and shall submit such other reports as the President shall direct.
(July 1, 1944, ch. 373, title IV, § 415, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 835.)
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
in subsec. (b) of this section relating to the requirement that the Panel submit to Congress an annual
evaluation of the efficacy of the Program and suggestions for improvements, see section 3003 of Pub. L.
104–66, as amended, set out as a note under section 1113
of Title 31, Money and Finance, and page 189 of House
Document No. 103–7.
TERMINATION OF ADVISORY PANELS
Advisory panels established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President
or an officer of the Federal Government, such panel is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a panel established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463,
Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 285a–5. Associate Director for Prevention; appointment; function
(a) There shall be in the Institute an Associate
Director for Prevention to coordinate and promote the programs in the Institute concerning
the prevention of cancer. The Associate Director
shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in
public health or preventive medicine.
(b) The Associate Director for Prevention
shall prepare for inclusion in the biennial report
made under section 284b 1 of this title a description of the prevention activities of the Institute,
including a description of the staff and resources
allocated to those activities.
(July 1, 1944, ch. 373, title IV, § 416, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 836.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
1 See

References in Text note below.

§ 285a–6

§ 285a–6. Breast and gynecological cancers
(a) Expansion and coordination of activities
The Director of the Institute, in consultation
with the National Cancer Advisory Board, shall
expand, intensify, and coordinate the activities
of the Institute with respect to research on
breast cancer, ovarian cancer, and other cancers
of the reproductive system of women.
(b) Coordination with other institutes
The Director of the Institute shall coordinate
the activities of the Director under subsection
(a) of this section with similar activities conducted by other national research institutes and
agencies of the National Institutes of Health to
the extent that such Institutes 1 and agencies
have responsibilities that are related to breast
cancer and other cancers of the reproductive
system of women.
(c) Programs for breast cancer
(1) In general
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for,
breast cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology
and causes of breast cancer;
(B) clinical research and related activities
concerning the causes, prevention, detection
and treatment of breast cancer;
(C) control programs with respect to
breast cancer in accordance with section
285a–1 of this title, including communitybased programs designed to assist women
who are members of medically underserved
populations, low-income populations, or minority groups;
(D) information and education programs
with respect to breast cancer in accordance
with section 285a–2 of this title; and
(E) research and demonstration centers
with respect to breast cancer in accordance
with section 285a–3 of this title, including
the development and operation of centers for
breast cancer research to bring together
basic and clinical, biomedical and behavioral
scientists to conduct basic, clinical, epidemiological, psychosocial, prevention and
treatment research and related activities on
breast cancer.
Not less than six centers shall be operated
under subparagraph (E). Activities of such
centers should include supporting new and innovative research and training programs for
new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in
paragraph (1) are implemented in accordance
with a plan for the programs. Such plan shall
include comments and recommendations that
1 So

in original. Probably should not be capitalized.

§ 285a–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Director of the Institute considers appropriate, with due consideration provided to the
professional judgment needs of the Institute
as expressed in the annual budget estimate
prepared in accordance with section 285a–2(9) 2
of this title. The Director of the Institute, in
consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the
plan to the President’s Cancer Panel, the Secretary and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President’s Cancer Panel, the Secretary, and the
Director of NIH.
(D) The Secretary shall provide a copy of the
plan submitted under subparagraph (A), and
any revisions submitted under subparagraph
(C), to the Committee on Energy and Commerce of the House of Representatives and the
Committee on Labor and Human Resources of
the Senate.
(d) Other cancers
In carrying out subsection (a) of this section,
the Director of the Institute shall conduct or
support research on ovarian cancer and other
cancers of the reproductive system of women.
Activities under such subsection shall provide
for the conduct and support of—
(1) basic research concerning the etiology
and causes of ovarian cancer and other cancers
of the reproductive system of women;
(2) clinical research and related activities
into the causes, prevention, detection and
treatment of ovarian cancer and other cancers
of the reproductive system of women;
(3) control programs with respect to ovarian
cancer and other cancers of the reproductive
system of women in accordance with section
285a–1 of this title;
(4) information and education programs with
respect to ovarian cancer and other cancers of
the reproductive system of women in accordance with section 285a–2 of this title; and
(5) research and demonstration centers with
respect to ovarian cancer and cancers of the
reproductive system in accordance with section 285a–3 of this title.
(e) Report
The Director of the Institute shall prepare, for
inclusion in the biennial report submitted under
section 284b 3 of this title, a report that describes
the activities of the National Cancer Institute
under the research programs referred to in subsection (a) of this section, that shall include—
(1) a description of the research plan with respect to breast cancer prepared under subsection (c) of this section;
(2) an assessment of the development, revision, and implementation of such plan;
(3) a description and evaluation of the
progress made, during the period for which
such report is prepared, in the research programs on breast cancer and cancers of the reproductive system of women;
2 So

in original. Probably should be section ‘‘285a–2(b)(9)’’.
References in Text note below.

3 See

Page 538

(4) a summary and analysis of expenditures
made, during the period for which such report
is made, for activities with respect to breast
cancer and cancers of the reproductive system
of women conducted and supported by the National Institutes of Health; and
(5) such comments and recommendations as
the Director considers appropriate.
(July 1, 1944, ch. 373, title IV, § 417, as added Pub.
L. 103–43, title IV, § 401, June 10, 1993, 107 Stat.
153.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (e),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 285a–7. Prostate cancer
(a) Expansion and coordination of activities
The Director of the Institute, in consultation
with the National Cancer Advisory Board, shall
expand, intensify, and coordinate the activities
of the Institute with respect to research on prostate cancer.
(b) Coordination with other institutes
The Director of the Institute shall coordinate
the activities of the Director under subsection
(a) of this section with similar activities conducted by other national research institutes and
agencies of the National Institutes of Health to
the extent that such Institutes 1 and agencies
have responsibilities that are related to prostate
cancer.
(c) Programs
(1) In general
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for,
prostate cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology
and causes of prostate cancer;
(B) clinical research and related activities
concerning the causes, prevention, detection
and treatment of prostate cancer;
(C) prevention and control and early detection programs with respect to prostate cancer in accordance with section 285a–1 of this
1 So

in original. Probably should not be capitalized.

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title, particularly as it relates to intensifying research on the role of prostate specific
antigen for the screening and early detection of prostate cancer;
(D) an Inter-Institute Task Force, under
the direction of the Director of the Institute, to provide coordination between relevant National Institutes of Health components of research efforts on prostate cancer;
(E) control programs with respect to prostate cancer in accordance with section
285a–1 of this title;
(F) information and education programs
with respect to prostate cancer in accordance with section 285a–2 of this title; and
(G) research and demonstration centers
with respect to prostate cancer in accordance with section 285a–3 of this title, including the development and operation of centers for prostate cancer research to bring together basic and clinical, biomedical and behavioral scientists to conduct basic, clinical,
epidemiological, psychosocial, prevention
and control, treatment, research, and related activities on prostate cancer.
Not less than six centers shall be operated
under subparagraph (G). Activities of such
centers should include supporting new and innovative research and training programs for
new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in
paragraph (1) are implemented in accordance
with a plan for the programs. Such plan shall
include comments and recommendations that
the Director of the Institute considers appropriate, with due consideration provided to the
professional judgment needs of the Institute
as expressed in the annual budget estimate
prepared in accordance with section 285a–2(9) 2
of this title. The Director of the Institute, in
consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the
plan to the President’s Cancer Panel, the Secretary, and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President’s Cancer Panel, the Secretary, and the
Director of NIH.
(D) The Secretary shall provide a copy of the
plan submitted under subparagraph (A), and
any revisions submitted under subparagraph
(C), to the Committee on Energy and Commerce of the House of Representatives and the
Committee on Labor and Human Resources of
the Senate.
(July 1, 1944, ch. 373, title IV, § 417A, as added
Pub. L. 103–43, title IV, § 402, June 10, 1993, 107
Stat. 155.)
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
2 So

in original. Probably should be section ‘‘285a–2(b)(9)’’.

§ 285a–9

and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 285a–8. Repealed. Pub. L. 109–482, title I,
§ 103(b)(15), Jan. 15, 2007, 120 Stat. 3687
Section, act July 1, 1944, ch. 373, title IV, § 417B, as
added Pub. L. 103–43, title IV, § 403(a), June 10, 1993, 107
Stat. 157; amended Pub. L. 105–340, title I, § 103, Oct. 31,
1998, 112 Stat. 3192; Pub. L. 106–505, title VI, § 602(b),
Nov. 13, 2000, 114 Stat. 2346, related to authorization of
appropriations.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 285a–9. Grants for education, prevention, and
early detection of radiogenic cancers and
diseases
(a) Definition
In this section the term ‘‘entity’’ means any—
(1) National Cancer Institute-designated
cancer center;
(2) Department of Veterans Affairs hospital
or medical center;
(3) Federally Qualified Health Center, community health center, or hospital;
(4) agency of any State or local government,
including any State department of health; or
(5) nonprofit organization.
(b) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration in consultation with the Director
of the National Institutes of Health and the Director of the Indian Health Service, may make
competitive grants to any entity for the purpose
of carrying out programs to—
(1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation
Exposure Compensation Act (42 U.S.C. 2210
note) for cancer as a preventative health
measure;
(2) provide appropriate referrals for medical
treatment of individuals screened under paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up
services;
(3) develop and disseminate public information and education programs for the detection,
prevention, and treatment of radiogenic cancers and diseases; and
(4) facilitate putative applicants in the documentation of claims as described in section
5(a) of the Radiation Exposure Compensation
Act (42 U.S.C. 2210 note).
(c) Indian Health Service
The programs under subsection (a) of this section shall include programs provided through

§ 285a–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Indian Health Service or through tribal contracts, compacts, grants, or cooperative agreements with the Indian Health Service and which
are determined appropriate to raising the health
status of Indians.
(d) Grant and contract authority
Entities receiving a grant under subsection (b)
of this section may expend the grant to carry
out the purpose described in such subsection.
(e) Health coverage unaffected
Nothing in this section shall be construed to
affect any coverage obligation of a governmental or private health plan or program relating to an individual referred to under subsection
(b)(1) of this section.
(July 1, 1944, ch. 373, title IV, § 417C, as added
Pub. L. 106–245, § 4, July 10, 2000, 114 Stat. 508;
amended Pub. L. 109–482, title I, §§ 103(b)(16),
104(b)(1)(F), Jan. 15, 2007, 120 Stat. 3687, 3693.)
REFERENCES IN TEXT
Sections 4 and 5 of the Radiation Exposure Compensation Act, referred to in subsec. (b)(1) and (4), are
sections 4 and 5 of Pub. L. 101–426, which are set out as
a note under section 2210 of this title.
AMENDMENTS
2007—Subsec. (f). Pub. L. 109–482, § 104(b)(1)(F), struck
out heading and text of subsec. (f). Text read as follows:
‘‘Beginning on October 1 of the year following the date
on which amounts are first appropriated to carry out
this section and annually on each October 1 thereafter,
the Secretary shall submit a report to the Committee
on the Judiciary and the Committee on Health, Education, Labor, and Pensions of the Senate and to the
Committee on the Judiciary and the Committee on
Commerce of the House of Representatives. Each report
shall summarize the expenditures and programs funded
under this section as the Secretary determines to be
appropriate.’’
Subsec. (g). Pub. L. 109–482, § 103(b)(16), struck out
heading and text of subsec. (g). Text read as follows:
‘‘There are authorized to be appropriated for the purpose of carrying out this section $20,000,000 for fiscal
year 1999 and such sums as may be necessary for each
of the fiscal years 2000 through 2009.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

Page 540

Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information and education for
patients and the general public with respect to
blood cancer, and particularly with respect to
the treatment of leukemia, lymphoma, and
multiple myeloma.
(2) Administration
The Agency determined by the Secretary
under paragraph (1) shall carry out this subsection in collaboration with private health
organizations that have national education
and patient assistance programs on blood-related cancers.
(July 1, 1944, ch. 373, title IV, § 417D, as added
Pub. L. 107–172, § 3, May 14, 2002, 116 Stat. 541;
amended Pub. L. 109–482, title I, § 103(b)(17), Jan.
15, 2007, 120 Stat. 3688.)
CODIFICATION
Section 3 of Pub. L. 107–172, which directed that section 417D (this section) be inserted after section 419C of
part C of title IV of the Public Health Service Act, was
executed by adding section 417D to part C of title IV of
the Public Health Service Act, to reflect the probable
intent of Congress, notwithstanding that part C does
not contain a section 419C.
AMENDMENTS
2007—Subsec. (a)(3). Pub. L. 109–482, § 103(b)(17)(A),
struck out heading and text of par. (3). Text read as follows: ‘‘For the purpose of carrying out this subsection,
there is authorized to be appropriated such sums as
may be necessary for fiscal year 2002 and each subsequent fiscal year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are available for such purpose.’’
Subsec. (b)(3). Pub. L. 109–482, § 103(b)(17)(B), struck
out heading and text of par. (3). Text read as follows:
‘‘For the purpose of carrying out this subsection, there
is authorized to be appropriated such sums as may be
necessary for fiscal year 2002 and each subsequent fiscal
year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are
available for such purpose.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285a–10. Research, information, and education
with respect to blood cancer

CONGRESSIONAL FINDINGS

(a) Joe Moakley Research Excellence Program
(1) In general
The Director of NIH shall expand, intensify,
and coordinate programs for the conduct and
support of research with respect to blood cancer, and particularly with respect to leukemia,
lymphoma, and multiple myeloma.
(2) Administration
The Director of NIH shall carry out this subsection through the Director of the National
Cancer Institute and in collaboration with any
other agencies that the Director determines to
be appropriate.
(b) Geraldine Ferraro Cancer Education Program
(1) In general
The Secretary shall direct the appropriate
agency within the Department of Health and

Pub. L. 107–172, § 2, May 14, 2002, 116 Stat. 541, provided
that: ‘‘Congress finds that:
‘‘(1) An estimated 109,500 people in the United
States will be diagnosed with leukemia, lymphoma,
and multiple myeloma in 2001.
‘‘(2) New cases of the blood cancers described in
paragraph (1) account for 8.6 percent of new cancer
cases.
‘‘(3) Those devastating blood cancers will cause the
deaths of an estimated 60,300 persons in the United
States in 2001. Every 9 minutes, a person in the
United States dies from leukemia, lymphoma, or
multiple myeloma.
‘‘(4) While less than 5 percent of Federal funds for
cancer research are spent on those blood cancers,
those blood cancers cause 11 percent of all cancer
deaths in the United States.
‘‘(5) Increased Federal support of research into leukemia, lymphoma, and multiple myeloma has resulted and will continue to result in significant advances in the treatment, and ultimately the cure, of
those blood cancers as well as other cancers.’’

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§ 285a–11. Pediatric cancer research and awareness
(a) Pediatric cancer research
(1) Programs of research excellence in pediatric cancer
The Secretary, in collaboration with the Director of NIH and other Federal agencies with
interest in prevention and treatment of pediatric cancer, shall continue to enhance, expand, and intensify pediatric cancer research
and other activities related to pediatric cancer, including therapeutically applicable research to generate effective treatments, pediatric preclinical testing, and pediatric clinical
trials through National Cancer Institute-supported pediatric cancer clinical trial groups
and their member institutions. In enhancing,
expanding, and intensifying such research and
other activities, the Secretary is encouraged
to take into consideration the application of
such research and other activities for minority, health disparity, and medically underserved communities. For purposes of this section, the term ‘‘pediatric cancer research’’
means research on the causes, prevention, diagnosis, recognition, treatment, and longterm effects of pediatric cancer.
(2) Peer review requirements
All grants awarded under this subsection
shall be awarded in accordance with section
289a of this title.
(b) Public awareness of pediatric cancers and
available treatments and research
(1) In general
The Secretary may award grants to childhood cancer professional and direct service organizations for the expansion and widespread
implementation of—
(A) activities that provide available information on treatment protocols to ensure
early access to the best available therapies
and clinical trials for pediatric cancers;
(B) activities that provide available information on the late effects of pediatric cancer treatment to ensure access to necessary
long-term medical and psychological care;
and
(C) direct resource services such as educational outreach for parents, peer-to-peer
and parent-to-parent support networks, information on school re-entry and postsecondary education, and resource directories or referral services for financial assistance, psychological counseling, and
other support services.
In awarding grants under this paragraph, the
Secretary is encouraged to take into consideration the extent to which an entity would use
such grant for purposes of making activities
and services described in this paragraph available to minority, health disparity, and medically underserved communities.
(2) Performance measurement, transparency,
and accountability
For each grant awarded under this subsection, the Secretary shall develop and implement metrics-based performance measures to

§ 285a–12

assess the effectiveness of activities funded
under such grant.
(3) Informational requirements
Any information made available pursuant to
a grant awarded under paragraph (1) shall be—
(A) culturally and linguistically appropriate as needed by patients and families affected by childhood cancer; and
(B) approved by the Secretary.
(c) Rule of construction
Nothing in this section shall be construed as
being inconsistent with the goals and purposes
of the Minority Health and Health Disparities
Research and Education Act of 2000 (42 U.S.C. 202
note).1
(d) Authorization of appropriations
For purposes of carrying out this section and
section 280e–3a of this title, there are authorized
to be appropriated $30,000,000 for each of fiscal
years 2009 through 2013. Such authorization of
appropriations is in addition to the authorization of appropriations established in section 282a
of this title with respect to such purpose. Funds
appropriated under this subsection shall remain
available until expended.
(July 1, 1944, ch. 373, title IV, § 417E, as added
Pub. L. 110–285, § 4(a), July 29, 2008, 122 Stat.
2629.)
REFERENCES IN TEXT
The Minority Health and Health Disparities Research
and Education Act of 2000, referred to in subsec. (c), is
Pub. L. 106–525, Nov. 22, 2000, 114 Stat. 2495. For complete classification of this Act to the Code, see Short
Title of 2000 Amendments note set out under section 201
of this title and Tables.

§ 285a–12. Interagency Breast Cancer and Environmental Research Coordinating Committee
(a) Interagency Breast Cancer and Environmental Research Coordinating Committee
(1) Establishment
Not later than 6 months after October 8,
2008, the Secretary shall establish a committee, to be known as the Interagency Breast
Cancer and Environmental Research Coordinating Committee (in this section referred to
as the ‘‘Committee’’).
(2) Duties
The Committee shall—
(A) share and coordinate information on
existing research activities, and make recommendations to the National Institutes of
Health and other Federal agencies regarding
how to improve existing research programs,
that are related to breast cancer research;
(B) develop a comprehensive strategy and
advise the National Institutes of Health and
other Federal agencies in the solicitation of
proposals for collaborative, multidisciplinary research, including proposals to
evaluate environmental and genomic factors
that may be related to the etiology of breast
cancer that would—
(i) result in innovative approaches to
study emerging scientific opportunities or
1 So

in original. See References in Text note below.

§ 285b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

eliminate knowledge gaps in research to
improve the research portfolio;
(ii) outline key research questions,
methodologies, and knowledge gaps;
(iii) expand the number of research proposals that involve collaboration between
2 or more national research institutes or
national centers, including proposals for
Common Fund research described in section 282(b)(7) of this title to improve the
research portfolio; and
(iv) expand the number of collaborative,
multidisciplinary, and multi-institutional
research grants;
(C) develop a summary of advances in
breast cancer research supported or conducted by Federal agencies relevant to the
diagnosis, prevention, and treatment of cancer and other diseases and disorders; and
(D) not later than 2 years after the date of
the establishment of the Committee, make
recommendations to the Secretary—
(i) regarding any appropriate changes to
research activities, including recommendations to improve the research portfolio of the National Institutes of Health
to ensure that scientifically-based strategic planning is implemented in support of
research priorities that impact breast cancer research activities;
(ii) to ensure that the activities of the
National Institutes of Health and other
Federal agencies, including the Department of Defense, are free of unnecessary
duplication of effort;
(iii) regarding public participation in decisions relating to breast cancer research
to increase the involvement of patient advocacy and community organizations representing a broad geographical area;
(iv) on how best to disseminate information on breast cancer research progress;
and
(v) on how to expand partnerships between public entities, including Federal
agencies, and private entities to expand
collaborative, cross-cutting research.
(3) Rule of construction
For the purposes of the Committee, when focusing on research to evaluate environmental
and genomic factors that may be related to
the etiology of breast cancer, nothing in this
section shall be construed to restrict the Secretary from including other forms of cancer,
as appropriate, when doing so may advance research in breast cancer or advance research in
other forms of cancer.
(4) Membership
(A) In general
The Committee shall be composed of the
following voting members:
(i) Not more than 7 voting Federal representatives as follows:
(I) The Director of the Centers for Disease Control and Prevention.
(II) The Director of the National Institutes of Health and the directors of such
national research institutes and national
centers (which may include the National

Page 542

Institute of Environmental Health Sciences) as the Secretary determines appropriate.
(III) One representative from the National Cancer Institute Board of Scientific Advisors, appointed by the Director of the National Cancer Institute.
(IV) The heads of such other agencies
of the Department of Health and Human
Services as the Secretary determines appropriate.
(V) Representatives of other Federal
agencies that conduct or support cancer
research, including the Department of
Defense.
(ii) 12 additional voting members appointed under subparagraph (B).
(B) Additional members
The Committee shall include additional
voting members appointed by the Secretary
as follows:
(i) 6 members shall be appointed from
among scientists, physicians, and other
health professionals, who—
(I) are not officers or employees of the
United States;
(II) represent multiple disciplines, including clinical, basic, and public health
sciences;
(III) represent different geographical
regions of the United States;
(IV) are from practice settings, academia, or other research settings; and
(V) are experienced in scientific peer
review process.
(ii) 6 members shall be appointed from
members of the general public, who represent individuals with breast cancer.
(C) Nonvoting members
The Committee shall include such nonvoting members as the Secretary determines
to be appropriate.
(5) Chairperson
The voting members of the Committee shall
select a chairperson from among such members. The selection of a chairperson shall be
subject to the approval of the Director of NIH.
(6) Meetings
The Committee shall meet at the call of the
chairperson of the Committee or upon the request of the Director of NIH, but in no case
less often than once each year.
(b) Review
The Secretary shall review the necessity of
the Committee in calendar year 2011 and, thereafter, at least once every 2 years.
(July 1, 1944, ch. 373, title IV, § 417F, as added
Pub. L. 110–354, § 2(a), Oct. 8, 2008, 122 Stat. 3984.)
SUBPART 2—NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE

§ 285b. Purpose of Institute
The general purpose of the National Heart,
Lung, and Blood Institute (hereafter in this subpart referred to as the ‘‘Institute’’) is the con-

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duct and support of research, training, health
information dissemination, and other programs
with respect to heart, blood vessel, lung, and
blood diseases and with respect to the use of
blood and blood products and the management
of blood resources.
(July 1, 1944, ch. 373, title IV, § 418, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 836.)
§ 285b–1. Heart, blood vessel, lung, and blood disease prevention and control programs
(a) The Director of the Institute shall conduct
and support programs for the prevention and
control of heart, blood vessel, lung, and blood
diseases. Such programs shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or
local governments, with nonprofit private entities that are community-based health agencies,
or with other appropriate public or nonprofit
private entities.
(b) In carrying out programs under subsection
(a) of this section, the Director of the Institute
shall give special consideration to the prevention and control of heart, blood vessel, lung, and
blood diseases in children, and in populations
that are at increased risk with respect to such
diseases.
(July 1, 1944, ch. 373, title IV, § 419, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 836; amended
Pub. L. 103–43, title V, § 505, June 10, 1993, 107
Stat. 160.)
AMENDMENTS
1993—Pub. L. 103–43 substituted subsecs. (a) and (b)
for former section which read as follows: ‘‘The Director
of the Institute, under policies established by the Director of NIH and after consultation with the advisory
council for the Institute, shall establish programs as
necessary for cooperation with other Federal health
agencies, State, local, and regional public health agencies, and nonprofit private health agencies in the diagnosis, prevention, and treatment (including the provision of emergency medical services) of heart, blood vessel, lung, and blood diseases, appropriately emphasizing
the prevention, diagnosis, and treatment of such diseases of children.’’

§ 285b–2. Information and education
The Director of the Institute shall collect,
identify, analyze, and disseminate on a timely
basis, through publications and other appropriate means, to patients, families of patients,
physicians and other health professionals, and
the general public, information on research, prevention, diagnosis, and treatment of heart,
blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of
such diseases, and on the use of blood and blood
products and the management of blood resources. In carrying out this section, the Director of the Institute shall place special emphasis
upon the utilization of collaborative efforts with
both the public and private sectors to—
(1) increase the awareness and knowledge of
health care professionals and the public regarding the prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and
(2) develop and disseminate to health professionals, patients and patient families, and the

§ 285b–3

public information designed to encourage
adults and children to adopt healthful practices concerning the prevention of such diseases.
(July 1, 1944, ch. 373, title IV, § 420, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 837; amended
Pub. L. 100–607, title I, § 126, Nov. 4, 1988, 102
Stat. 3055.)
AMENDMENTS
1988—Pub. L. 100–607 amended second sentence generally. Prior to amendment, second sentence read as follows: ‘‘In carrying out this section the Director of the
Institute shall place special emphasis upon—
‘‘(1) the dissemination of information regarding
diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight
control, and other factors affecting the prevention of
arteriosclerosis and other cardiovascular diseases and
of pulmonary and blood diseases; and
‘‘(2) the dissemination of information designed to
encourage children to adopt healthful habits respecting the risk factors related to the prevention of such
diseases.’’

§ 285b–3. National Heart, Blood Vessel, Lung, and
Blood Diseases and Blood Resources Program; administrative provisions
(a)(1) The National Heart, Blood Vessel, Lung,
and Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as
the ‘‘Program’’) may provide for—
(A) investigation into the epidemiology, etiology, and prevention of all forms and aspects
of heart, blood vessel, lung, and blood diseases,
including investigations into the social, environmental, behavioral, nutritional, biological,
and genetic determinants and influences involved in the epidemiology, etiology, and prevention of such diseases;
(B) studies and research into the basic biological processes and mechanisms involved in
the underlying normal and abnormal heart,
blood vessel, lung, and blood phenomena;
(C) research into the development, trial, and
evaluation of techniques, drugs, and devices
(including computers) used in, and approaches
to, the diagnosis, treatment (including the
provision of emergency medical services), and
prevention of heart, blood vessel, lung, and
blood diseases and the rehabilitation of patients suffering from such diseases;
(D) establishment of programs that will
focus and apply scientific and technological
efforts involving the biological, physical, and
engineering sciences to all facets of heart,
blood vessel, lung, and blood diseases with emphasis on the refinement, development, and
evaluation of technological devices that will
assist, replace, or monitor vital organs and
improve instrumentation for detection, diagnosis, and treatment of and rehabilitation
from such diseases;
(E) establishment of programs for the conduct and direction of field studies, large-scale
testing and evaluation, and demonstration of
preventive, diagnostic, therapeutic, and rehabilitative approaches to, and emergency medical services for, such diseases;
(F) studies and research into blood diseases
and blood, and into the use of blood for clinical purposes and all aspects of the manage-

§ 285b–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment of blood resources in the United States,
including the collection, preservation, fractionation, and distribution of blood and blood
products;
(G) the education (including continuing education) and training of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood
diseases and blood resources;
(H) public and professional education relating to all aspects of such diseases, including
the prevention of such diseases, and the use of
blood and blood products and the management
of blood resources;
(I) establishment of programs for study and
research into heart, blood vessel, lung, and
blood diseases of children (including cystic fibrosis, hyaline membrane, hemolytic diseases
such as sickle cell anemia and Cooley’s anemia, and hemophilic diseases) and for the development and demonstration of diagnostic,
treatment, and preventive approaches to such
diseases; and
(J) establishment of programs for study, research, development, demonstrations and evaluation of emergency medical services for people who become critically ill in connection
with heart, blood vessel, lung, or blood diseases.
(2) The Program shall be coordinated with
other national research institutes to the extent
that they have responsibilities respecting such
diseases and shall give special emphasis to the
continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute
of Neurological and Communicative Disorders
and Stroke. The Director of the Institute, with
the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
(b) In carrying out the Program, the Director
of the Institute, under policies established by
the Director of NIH—
(1) may, after consultation with the advisory
council for the Institute, obtain (in accordance with section 3109 of title 5, but without
regard to the limitation in such section on the
period of such service) the services of not more
than one hundred experts or consultants who
have scientific or professional qualifications;
(2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung,
and blood disease and blood resource laboratories, research, training, and other facilities,
equipment, and such other real or personal
property as the Director determines necessary;
(B) may, in consultation with the advisory
council for the Institute, make grants for construction or renovation of facilities; and
(C) may, in consultation with the advisory
council for the Institute, acquire, without regard to section 8141 of title 40, by lease or
otherwise, through the Administrator of Gen-

Page 544

eral Services, buildings or parts of buildings in
the District of Columbia or communities located adjacent to the District of Columbia for
the use of the Institute for a period not to exceed ten years;
(3) subject to section 284(b)(2) of this title
and without regard to section 3324 of title 31
and section 6101 of title 41, may enter into
such contracts, leases, cooperative agreements, or other transactions, as may be necessary in the conduct of the Director’s functions, with any public agency, or with any person, firm, association, corporation, or educational institutions;
(4) may make grants to public and nonprofit
private entities to assist in meeting the cost
of the care of patients in hospitals, clinics,
and related facilities who are participating in
research projects; and
(5) shall, in consultation with the advisory
council for the Institute, conduct appropriate
intramural training and education programs,
including continuing education and laboratory
and clinical research training programs.
Except as otherwise provided, experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from
their place of service and for other expenses associated with their assignment. Such expenses
shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the
expert or consultant has agreed in writing to
complete the entire period of the assignment or
one year of the assignment, whichever is shorter, unless separated or reassigned for reasons
which are beyond the control of the expert or
consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by
the United States for such expenses is recoverable from the expert or consultant as a debt due
the United States. The Secretary may waive in
whole or in part a right of recovery under the
preceding sentence.
(July 1, 1944, ch. 373, title IV, § 421, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 837; amended
Pub. L. 100–607, title I, § 127, Nov. 4, 1988, 102
Stat. 3055; Pub. L. 103–43, title V, § 501, title XX,
§ 2008(b)(3), June 10, 1993, 107 Stat. 158, 211.)
CODIFICATION
In subsec. (b)(2)(C), ‘‘section 8141 of title 40’’ substituted for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on
authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116
Stat. 1303, the first section of which enacted Title 40,
Public Buildings, Property, and Works.
In subsec. (b)(3), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
1993—Subsec. (b)(1). Pub. L. 103–43, § 2008(b)(3), inserted comma after ‘‘may’’.
Subsec. (b)(5). Pub. L. 103–43, § 501, added par. (5).
1988—Subsec. (a)(1)(D). Pub. L. 100–607, § 127(1), inserted ‘‘and rehabilitation from’’ after ‘‘and treatment
of’’.
Subsec. (b)(1). Pub. L. 100–607, § 127(2), substituted
‘‘after consultation with’’ for ‘‘, after approval of’’.

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§ 285b–4. National research and demonstration
centers
(a) Heart, blood vessel, lung, blood diseases, and
blood resources; utilization of centers for
prevention programs
(1) The Director of the Institute may provide,
in accordance with subsection (c) of this section,
for the development of—
(A) ten centers for basic and clinical research into, training in, and demonstration of,
advanced diagnostic, prevention, and treatment and rehabilitation methods (including
methods of providing emergency medical services) for heart and blood vessel diseases;
(B) ten centers for basic and clinical research into, training in, and demonstration of,
advanced diagnostic, prevention, and treatment and rehabilitation methods (including
methods of providing emergency medical services) for lung diseases (including bronchitis,
emphysema, asthma, cystic fibrosis, and other
lung diseases of children);
(C) ten centers for basic and clinical research into, training in, and demonstration of,
advanced diagnostic, prevention, and treatment methods (including methods of providing
emergency medical services) for blood diseases
and research into blood, in the use of blood
products and in the management of blood resources; and
(D) three centers for basic and clinical research into, training in, and demonstration of,
advanced diagnostic, prevention, and treatment (including genetic studies, intrauterine
environment studies, postnatal studies, heart
arrhythmias, and acquired heart disease and
preventive cardiology) for cardiovascular diseases in children.
(2) The centers developed under paragraph (1)
shall, in addition to being utilized for research,
training, and demonstrations, be utilized for the
following prevention programs for cardiovascular, pulmonary, and blood diseases:
(A) Programs to develop improved methods
of detecting individuals with a high risk of developing cardiovascular, pulmonary, and blood
diseases.
(B) Programs to develop improved methods
of intervention against those factors which
cause individuals to have a high risk of developing such diseases.
(C) Programs to develop health professions
and allied health professions personnel highly
skilled in the prevention of such diseases.
(D) Programs to develop improved methods
of providing emergency medical services for
persons with such diseases.
(E) Programs of continuing education for
health and allied health professionals in the
diagnosis, prevention, and treatment of such
diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the
prevention and early diagnosis and treatment
of such diseases and the maintenance of
health.
(3) The research, training, and demonstration
activities carried out through any such center
may relate to any one or more of the diseases
referred to in paragraph (1) of this subsection.

§ 285b–4

(b) Sickle cell anemia
The Director of the Institute shall provide, in
accordance with subsection (c) of this section,
for the development of ten centers for basic and
clinical research into the diagnosis, treatment,
and control of sickle cell anemia.
(c) Cooperative agreements and grants for establishing and supporting; uses for Federal payments; period of support, additional periods
(1) The Director of the Institute may enter
into cooperative agreements with and make
grants to public or private nonprofit entities to
pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical
research into, training in, and demonstration of
the management of blood resources and advanced diagnostic, prevention, and treatment
methods for heart, blood vessel, lung, or blood
diseases.
(2) A cooperative agreement or grant under
paragraph (1) shall be entered into in accordance
with policies established by the Director of NIH
and after consultation with the Institute’s advisory council.
(3) Federal payments made under a cooperative agreement or grant under paragraph (1)
may be used for—
(A) construction (notwithstanding any limitation under section 289e of this title);
(B) staffing and other basic operating costs,
including such patient care costs as are required for research;
(C) training, including training for allied
health professionals; and
(D) demonstration purposes.
As used in this subsection, the term ‘‘construction’’ does not include the acquisition of land,
and the term ‘‘training’’ does not include research training for which Ruth L. Kirschstein
National Research Service Awards may be provided under section 288 of this title.
(4) Support of a center under paragraph (1)
may be for a period of not to exceed five years.
Such period may be extended by the Director for
additional periods of not more than five years
each if the operations of such center have been
reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to
the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, § 422, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 839; amended
Pub. L. 100–607, title I, § 128, Nov. 4, 1988, 102
Stat. 3055; Pub. L. 103–43, title V, § 502, June 10,
1993, 107 Stat. 158; Pub. L. 107–206, title I, § 804(c),
Aug. 2, 2002, 116 Stat. 874.)
AMENDMENTS
2002—Subsec. (c)(3). Pub. L. 107–206 substituted ‘‘Ruth
L. Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’ in concluding provisions.
1993—Subsec. (a)(1)(D). Pub. L. 103–43 added subpar.
(D).
1988—Subsec. (a)(1)(A), (B). Pub. L. 100–607 inserted
‘‘and rehabilitation’’ after ‘‘prevention, and treatment’’.

§ 285b–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 285b–5. Repealed. Pub. L. 100–607, title I, § 129,
Nov. 4, 1988, 102 Stat. 3055
Section, act July 1, 1944, ch. 373, title IV, § 423, as
added Nov. 20, 1985, Pub. L. 99–158, § 2, 99 Stat. 841, directed Secretary to establish an Interagency Technical
Committee on Heart, Blood Vessel, Lung, and Blood
Diseases and Blood Resources.

§ 285b–6. Associate Director for Prevention; appointment; function
(a) There shall be in the Institute an Associate
Director for Prevention to coordinate and promote the programs in the Institute concerning
the prevention of heart, blood vessel, lung, and
blood diseases. The Associate Director shall be
appointed by the Director of the Institute from
individuals who because of their professional
training or experience are experts in public
health or preventive medicine.
(b) The Associate Director for Prevention
shall prepare for inclusion in the biennial report
made under section 284b 1 of this title a description of the prevention activities of the Institute,
including a description of the staff and resources
allocated to those activities.
(July 1, 1944, ch. 373, title IV, § 423, formerly § 424,
as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat.
841; renumbered § 423, Pub. L. 100–607, title I,
§ 129, Nov. 4, 1988, 102 Stat. 3055.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
PRIOR PROVISIONS
A prior section 423 of act July 1, 1944, was classified
to section 285b–5 of this title prior to repeal by Pub. L.
100–607.

§ 285b–7. National Center on Sleep Disorders Research
(a) Establishment
Not later than 1 year after June 10, 1993, the
Director of the Institute shall establish the National Center on Sleep Disorders Research (in
this section referred to as the ‘‘Center’’). The
Center shall be headed by a director, who shall
be appointed by the Director of the Institute.
(b) Purpose
The general purpose of the Center is—
(1) the conduct and support of research,
training, health information dissemination,
and other activities with respect to sleep disorders, including biological and circadian
rhythm research, basic understanding of sleep,
chronobiological and other sleep related research; and
(2) to coordinate the activities of the Center
with similar activities of other Federal agencies, including the other agencies of the National Institutes of Health, and similar activities of other public entities and nonprofit entities.
(c) Sleep Disorders Research Advisory Board
(1) The Director of the National Institutes of
Health shall establish a board to be known as

the Sleep Disorders Research Advisory Board (in
this section referred to as the ‘‘Advisory
Board’’).
(2) The Advisory Board shall advise, assist,
consult with, and make recommendations to the
Director of the National Institutes of Health,
through the Director of the Institute, and the
Director of the Center concerning matters relating to the scientific activities carried out by and
through the Center and the policies respecting
such activities, including recommendations with
respect to the plan required in subsection (c) 1 of
this section.
(3)(A) The Director of the National Institutes
of Health shall appoint to the Advisory Board 12
appropriately qualified representatives of the
public who are not officers or employees of the
Federal Government. Of such members, eight
shall be representatives of health and scientific
disciplines with respect to sleep disorders and
four shall be individuals representing the interests of individuals with or undergoing treatment
for sleep disorders.
(B) The following officials shall serve as ex
officio members of the Advisory Board:
(i) The Director of the National Institutes of
Health.
(ii) The Director of the Center.
(iii) The Director of the National Heart,
Lung and Blood Institute.
(iv) The Director of the National Institute of
Mental Health.
(v) The Director of the National Institute on
Aging.
(vi) The Director of the Eunice Kennedy
Shriver National Institute of Child Health and
Human Development.
(vii) The Director of the National Institute
of Neurological Disorders and Stroke.
(viii) The Assistant Secretary for Health.
(ix) The Assistant Secretary of Defense
(Health Affairs).
(x) The Chief Medical Director of the Veterans’ Administration.
(4) The members of the Advisory Board shall,
from among the members of the Advisory Board,
designate an individual to serve as the chair of
the Advisory Board.
(5) Except as inconsistent with, or inapplicable
to, this section, the provisions of section 284a of
this title shall apply to the advisory board 2 established under this section in the same manner
as such provisions apply to any advisory council
established under such section.
(d) Development of comprehensive research
plan; revision
(1) After consultation with the Director of the
Center and the advisory board 2 established
under subsection (c) of this section, the Director
of the National Institutes of Health shall develop a comprehensive plan for the conduct and
support of sleep disorders research.
(2) The plan developed under paragraph (1)
shall identify priorities with respect to such research and shall provide for the coordination of
such research conducted or supported by the
agencies of the National Institutes of Health.
1 So

1 See

References in Text note below.

Page 546

2 So

in original. Probably should be subsection ‘‘(d)’’.
in original. Probably should be capitalized.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) The Director of the National Institutes of
Health (after consultation with the Director of
the Center and the advisory board 2 established
under subsection (c) of this section) shall revise
the plan developed under paragraph (1) as appropriate.
(e) Collection and dissemination of information
The Director of the Center, in cooperation
with the Centers for Disease Control and Prevention, is authorized to coordinate activities
with the Department of Transportation, the Department of Defense, the Department of Education, the Department of Labor, and the Department of Commerce to collect data, conduct
studies, and disseminate public information concerning the impact of sleep disorders and sleep
deprivation.
(July 1, 1944, ch. 373, title IV, § 424, as added Pub.
L. 103–43, title V, § 503, June 10, 1993, 107 Stat.
159; amended Pub. L. 110–154, § 1(b)(5), Dec. 21,
2007, 121 Stat. 1827.)
AMENDMENTS
2007—Subsec. (c)(3)(B)(vi). Pub. L. 110–154 substituted
‘‘Eunice Kennedy Shriver National Institute of Child
Health and Human Development’’ for ‘‘National Institute of Child Health and Human Development’’.
CHANGE OF NAME
Reference to Chief Medical Director of Department of
Veterans Affairs deemed to refer to Under Secretary for
Health of Department of Veterans Affairs pursuant to
section 302(e) of Pub. L. 102–405, set out as a note under
section 305 of Title 38, Veterans’ Benefits.
Reference to Chief Medical Director of Veterans’ Administration deemed to refer to Chief Medical Director
of Department of Veterans Affairs pursuant to section
10 of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 201 of Title 38.
TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by Congress, its duration is otherwise provided
by law. See sections 3(2) and 14 of Pub. L. 92–463, Oct.
6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title
5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 285b–7a. Heart attack, stroke, and other cardiovascular diseases in women
(a) In general
The Director of the Institute shall expand, intensify, and coordinate research and related activities of the Institute with respect to heart attack, stroke, and other cardiovascular diseases
in women.
(b) Coordination with other institutes
The Director of the Institute shall coordinate
activities under subsection (a) of this section
with similar activities conducted by the other
national research institutes and agencies of the

§ 285b–7a

National Institutes of Health to the extent that
such Institutes and agencies have responsibilities that are related to heart attack, stroke,
and other cardiovascular diseases in women.
(c) Certain programs
In carrying out subsection (a) of this section,
the Director of the Institute shall conduct or
support research to expand the understanding of
the causes of, and to develop methods for preventing, cardiovascular diseases in women. Activities under such subsection shall include conducting and supporting the following:
(1) Research to determine the reasons underlying the prevalence of heart attack, stroke,
and other cardiovascular diseases in women,
including African-American women and other
women who are members of racial or ethnic
minority groups.
(2) Basic research concerning the etiology
and causes of cardiovascular diseases in
women.
(3) Epidemiological studies to address the
frequency and natural history of such diseases
and the differences among men and women,
and among racial and ethnic groups, with respect to such diseases.
(4) The development of safe, efficient, and
cost-effective diagnostic approaches to evaluating women with suspected ischemic heart
disease.
(5) Clinical research for the development and
evaluation of new treatments for women, including rehabilitation.
(6) Studies to gain a better understanding of
methods of preventing cardiovascular diseases
in women, including applications of effective
methods for the control of blood pressure,
lipids, and obesity.
(7) Information and education programs for
patients and health care providers on risk factors associated with heart attack, stroke, and
other cardiovascular diseases in women, and
on the importance of the prevention or control
of such risk factors and timely referral with
appropriate diagnosis and treatment. Such
programs shall include information and education on health-related behaviors that can
improve such important risk factors as smoking, obesity, high blood cholesterol, and lack
of exercise.
(July 1, 1944, ch. 373, title IV, § 424A, as added
Pub. L. 105–340, title I, § 104, Oct. 31, 1998, 112
Stat. 3192; amended Pub. L. 109–482, title I,
§ 103(b)(18), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1999 through 2003. The authorization of appropriations established in the preceding sentence is in addition to any other authorization
of appropriation that is available for such purpose.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285b–7b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 285b–7b. Coordination of Federal asthma activities
(a) In general
The Director of 1 Institute shall, through the
National Asthma Education Prevention Program Coordinating Committee—
(1) identify all Federal programs that carry
out asthma-related activities; and
(2) develop, in consultation with appropriate
Federal agencies and professional and voluntary health organizations, a Federal plan
for responding to asthma.
(b) Representation of the Department of Housing
and Urban Development
A representative of the Department of Housing and Urban Development shall be included on
the National Asthma Education Prevention Program Coordinating Committee for the purpose of
performing the tasks described in subsection (a)
of this section.
(July 1, 1944, ch. 373, title IV, § 424B, as added
Pub. L. 106–310, div. A, title V, § 521, Oct. 17, 2000,
114 Stat. 1116; amended Pub. L. 109–482, title I,
§§ 103(b)(19), 104(b)(1)(G), Jan. 15, 2007, 120 Stat.
3688, 3693.)
AMENDMENTS
2007—Subsec. (a). Pub. L. 109–482, § 104(b)(1)(G), inserted ‘‘and’’ at end of par. (1), substituted a period for
‘‘; and’’ at end of par. (2), and struck out par. (3) which
read as follows: ‘‘not later than 12 months after October 17, 2000, submit recommendations to the appropriate committees of the Congress on ways to strengthen and improve the coordination of asthma-related activities of the Federal Government.’’
Subsec. (c). Pub. L. 109–482, § 103(b)(19), struck out
heading and text of subsec. (c). Text read as follows:
‘‘For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285b–7c. Tuberculosis
(a) In general
The Director of the National Institutes of
Health may expand, intensify, and coordinate
research and development and related activities
of the Institutes with respect to tuberculosis including activities toward the goal of eliminating
such disease.
(b) Certain activities
Activities under subsection (a) may include—
(1) enhancing basic and clinical research on
tuberculosis, including drug resistant tuberculosis;
(2) expanding research on the relationship
between such disease and the human immunodeficiency virus; and
(3) developing new tools for the elimination
of tuberculosis, including public health interventions and methods to enhance detection
and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.
1 So

in original. Probably should be followed by ‘‘the’’.

Page 548

(July 1, 1944, ch. 373, title IV, § 424C, as added
Pub. L. 110–392, title II, § 201, Oct. 13, 2008, 122
Stat. 4201.)
§ 285b–8. Congenital heart disease
(a) In general
The Director of the Institute may expand, intensify, and coordinate research and related activities of the Institute with respect to congenital heart disease, which may include congenital
heart disease research with respect to—
(1) causation of congenital heart disease, including genetic causes;
(2) long-term outcomes in individuals with
congenital heart disease, including infants,
children, teenagers, adults, and elderly individuals;
(3) diagnosis, treatment, and prevention;
(4) studies using longitudinal data and retrospective analysis to identify effective treatments and outcomes for individuals with congenital heart disease; and
(5) identifying barriers to life-long care for
individuals with congenital heart disease.
(b) Coordination of research activities
The Director of the Institute may coordinate
research efforts related to congenital heart disease among multiple research institutions and
may develop research networks.
(c) Minority and medically underserved communities
In carrying out the activities described in this
section, the Director of the Institute shall consider the application of such research and other
activities to minority and medically underserved communities.
(July 1, 1944, ch. 373, title IV, § 425, as added Pub.
L. 111–148, title X, § 10411(b)(2), Mar. 23, 2010, 124
Stat. 989.)
PRIOR PROVISIONS
A prior section 285b–8, act July 1, 1944, ch. 373, title
IV, § 425, as added Pub. L. 103–43, title V, § 504, June 10,
1993, 107 Stat. 160, authorized appropriations to carry
out this subpart, prior to repeal by Pub. L. 109–482, title
I, §§ 103(b)(20), 109, Jan. 15, 2007, 120 Stat. 3688, 3697, applicable only with respect to amounts appropriated for
fiscal year 2007 or subsequent fiscal years.
SUBPART 3—NATIONAL INSTITUTE OF DIABETES
AND DIGESTIVE AND KIDNEY DISEASES

§ 285c. Purpose of Institute
The general purpose of the National Institute
of Diabetes and Digestive and Kidney Diseases
(hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of research,
training, health information dissemination, and
other programs with respect to diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic diseases.
(July 1, 1944, ch. 373, title IV, § 426, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 841.)
STUDY ON METABOLIC DISORDERS
Pub. L. 106–310, div. A, title XXVIII, § 2802, Oct. 17,
2000, 114 Stat. 1167, provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services (in this section referred to as the ‘Sec-

Page 549

TITLE 42—THE PUBLIC HEALTH AND WELFARE

retary’) shall, in consultation with relevant experts or
through the Institute of Medicine, study issues related
to treatment of PKU and other metabolic disorders for
children, adolescents, and adults, and mechanisms to
assure access to effective treatment, including special
diets, for children and others with PKU and other metabolic disorders. Such mechanisms shall be evidencebased and reflect the best scientific knowledge regarding effective treatment and prevention of disease progression.
‘‘(b) DISSEMINATION OF RESULTS.—Upon completion of
the study referred to in subsection (a), the Secretary
shall disseminate and otherwise make available the results of the study to interested groups and organizations, including insurance commissioners, employers,
private insurers, health care professionals, State and
local public health agencies, and State agencies that
carry out the Medicaid program under title XIX of the
Social Security Act [section 1396 et seq. of this title] or
the State children’s health insurance program under
title XXI of such Act [section 1397aa et seq. of this
title].
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
such sums as may be necessary for each of the fiscal
years 2001 through 2003.’’
REVIEW OF DISEASE RESEARCH PROGRAMS OF THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND
KIDNEY DISEASES
Section 10 of Pub. L. 99–158 provided that: ‘‘The Secretary of Health and Human Services shall conduct an
administrative review of the disease research programs
of the National Institute of Diabetes and Digestive and
Kidney Diseases to determine if any of such programs
could be more effectively and efficiently managed by
other national research institutes. The Secretary shall
complete such review within the one-year period beginning on the date of enactment of this Act [Nov. 20,
1985].’’

§ 285c–1. Data systems and information clearinghouses
(a) National Diabetes Data System and National
Diabetes Clearinghouse
The Director of the Institute shall (1) establish the National Diabetes Data System for the
collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with diabetes, including, where possible,
data involving general populations for the purpose of detection of individuals with a risk of developing diabetes, and (2) establish the National
Diabetes Information Clearinghouse to facilitate and enhance knowledge and understanding
of diabetes on the part of health professionals,
patients, and the public through the effective
dissemination of information.
(b) National Digestive Diseases Data System and
National Digestive Diseases Information
Clearinghouse
The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from
patient populations with digestive diseases, including, where possible, data involving general
populations for the purpose of detection of individuals with a risk of developing digestive diseases, and (2) establish the National Digestive
Diseases Information Clearinghouse to facilitate
and enhance knowledge and understanding of digestive diseases on the part of health professionals, patients, and the public through the effective dissemination of information.

§ 285c–2

(c) National Kidney and Urologic Diseases Data
System and National Kidney and Urologic
Diseases Information Clearinghouse
The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases
Data System for the collection, storage, analysis, retrieval, and dissemination of data derived
from patient populations with kidney and urologic diseases, including, where possible, data
involving general populations for the purpose of
detection of individuals with a risk of developing kidney and urologic diseases, and (2) establish the National Kidney and Urologic Diseases
Information Clearinghouse to facilitate and enhance knowledge and understanding of kidney
and urologic diseases on the part of health professionals, patients, and the public through the
effective dissemination of information.
(July 1, 1944, ch. 373, title IV, § 427, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 841.)
§ 285c–2. Division Directors for Diabetes, Endocrinology, and Metabolic Diseases, Digestive
Diseases and Nutrition, and Kidney, Urologic, and Hematologic Diseases; functions
(a)(1) In the Institute there shall be a Division
Director for Diabetes, Endocrinology, and Metabolic Diseases, a Division Director for Digestive
Diseases and Nutrition, and a Division Director
for Kidney, Urologic, and Hematologic Diseases.
Such Division Directors, under the supervision
of the Director of the Institute, shall be responsible for—
(A) developing a coordinated plan (including
recommendations for expenditures) for each of
the national research institutes within the National Institutes of Health with respect to research and training concerning diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and
hematologic diseases;
(B) assessing the adequacy of management
approaches for the activities within such institutes concerning such diseases and nutrition
and developing improved approaches if needed;
(C) monitoring and reviewing expenditures
by such institutes concerning such diseases
and nutrition; and
(D) identifying research opportunities concerning such diseases and nutrition and recommending ways to utilize such opportunities.
(2) The Director of the Institute shall transmit
to the Director of NIH the plans, recommendations, and reviews of the Division Directors
under subparagraphs (A) through (D) of paragraph (1) together with such comments and recommendations as the Director of the Institute
determines appropriate.
(b) The Director of the Institute, acting
through the Division Director for Diabetes, Endocrinology, and Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the Division Director for Kidney, Urologic, and Hematologic Diseases, shall—
(1) carry out programs of support for research and training (other than training for
which Ruth L. Kirschstein National Research
Service Awards may be made under section 288
of this title) in the diagnosis, prevention, and

§ 285c–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

treatment of diabetes mellitus and endocrine
and metabolic diseases, digestive diseases and
nutritional disorders, and kidney, urologic,
and hematologic diseases, including support
for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and
interdisciplinary research programs; and
(2) establish programs of evaluation, planning, and dissemination of knowledge related
to such research and training.
(July 1, 1944, ch. 373, title IV, § 428, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 842; amended
Pub. L. 103–43, title XX, § 2008(b)(4), June 10, 1993,
107 Stat. 211; Pub. L. 107–206, title I, § 804(c), Aug.
2, 2002, 116 Stat. 874.)
AMENDMENTS
2002—Subsec. (b)(1). Pub. L. 107–206 substituted ‘‘Ruth
L. Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’.
1993—Subsec. (b). Pub. L. 103–43 substituted ‘‘the’’ for
‘‘the the’’ before ‘‘Division Director for Diabetes’’ in introductory provisions.

§ 285c–3. Interagency coordinating committees
(a) Establishment and purpose
For the purpose of—
(1) better coordination of the research activities of all the national research institutes
relating to diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic
diseases; and
(2) coordinating those aspects of all Federal
health programs and activities relating to
such diseases to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication
and exchange of information necessary to
maintain adequate coordination of such programs and activities;
the Secretary shall establish a Diabetes Mellitus
Interagency Coordinating Committee, a Digestive Diseases Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic
Diseases Coordinating Committee (hereafter in
this section individually referred to as a ‘‘Committee’’).
(b) Membership; chairman; meetings
Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research with respect to the diseases for which the Committee is
established, the Division Director of the Institute for the diseases for which the Committee is
established, the Under Secretary for Health of
the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs
(or the designees of such officers) and shall include representation from all other Federal departments and agencies whose programs involve
health functions or responsibilities relevant to
such diseases, as determined by the Secretary.
Each Committee shall be chaired by the Director of NIH (or the designee of the Director).
Each Committee shall meet at the call of the
chairman, but not less often than four times a
year.
(July 1, 1944, ch. 373, title IV, § 429, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 843; amended

Page 550

Pub. L. 100–527, § 10(4), Oct. 25, 1988, 102 Stat.
2641; Pub. L. 102–405, title III, § 302(e)(1), Oct. 9,
1992, 106 Stat. 1985; Pub. L. 108–362, § 3, Oct. 25,
2004, 118 Stat. 1703; Pub. L. 109–482, title I,
§ 104(b)(1)(H), Jan. 15, 2007, 120 Stat. 3693.)
AMENDMENTS
2007—Subsecs. (c), (d). Pub. L. 109–482 struck out subsecs. (c) and (d) which required an annual report detailing the work of the Committee in carrying out subsec.
(a) and an annual assessment on Federal pancreatic
islet cell transplantation, respectively.
2004—Subsec. (d). Pub. L. 108–362 added subsec. (d).
1992—Subsec. (b). Pub. L. 102–405 substituted ‘‘Under
Secretary for Health of the Department of Veterans Affairs’’ for ‘‘Chief Medical Director of the Department of
Veterans Affairs’’.
1988—Subsec. (b). Pub. L. 100–527 substituted ‘‘Chief
Medical Director of the Department of Veterans Affairs’’ for ‘‘Chief Medical Director of the Veterans’ Administration’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–527 effective Mar. 15, 1989,
see section 18(a) of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 301 of
Title 38, Veterans’ Benefits.

§ 285c–4. Advisory boards
(a) Establishment
The Secretary shall establish in the Institute
the National Diabetes Advisory Board, the National Digestive Diseases Advisory Board, and
the National Kidney and Urologic Diseases Advisory Board (hereafter in this section individually referred to as an ‘‘Advisory Board’’).
(b) Membership; ex officio members
Each Advisory Board shall be composed of
eighteen appointed members and nonvoting ex
officio members as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who
are scientists, physicians, and other health
professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to the diseases with respect to which
the Advisory Board is established; and
(B) six members from the general public
who are knowledgeable with respect to such
diseases, including at least one member who
is a person who has such a disease and one
member who is a parent of a person who has
such a disease.
Of the appointed members at least five shall
by virtue of training or experience be knowledgeable in the fields of health education,
nursing, data systems, public information, and
community program development.
(2)(A) The following shall be ex officio members of each Advisory Board:
(i) The Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute of Diabetes and Digestive and Kidney Diseases, the Director of the Centers for
Disease Control and Prevention, the Under

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Secretary for Health of the Department of
Veterans Affairs, the Assistant Secretary of
Defense for Health Affairs, and the Division
Director of the National Institute of Diabetes and Digestive and Kidney Diseases for
the diseases for which the Board is established (or the designees of such officers).
(ii) Such other officers and employees of
the United States as the Secretary determines necessary for the Advisory Board to
carry out its functions.
(B) In the case of the National Diabetes Advisory Board, the following shall also be ex
officio members: The Director of the National
Heart, Lung, and Blood Institute, the Director
of the National Eye Institute, the Director of
the Eunice Kennedy Shriver National Institute of Child Health and Human Development,
and the Administrator of the Health Resources
and Services Administration (or the designees
of such officers).
(c) Compensation
Members of an Advisory Board who are officers or employees of the Federal Government
shall serve as members of the Advisory Board
without compensation in addition to that received in their regular public employment.
Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18
of the General Schedule for each day (including
traveltime) they are engaged in the performance
of their duties as members of the Board.
(d) Term of office; vacancy
The term of office of an appointed member of
an Advisory Board is four years, except that no
term of office may extend beyond the expiration
of the Advisory Board. Any member appointed
to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A
member may serve after the expiration of the
member’s term until a successor has taken office. If a vacancy occurs in an Advisory Board,
the Secretary shall make an appointment to fill
the vacancy not later than 90 days from the date
the vacancy occurred.
(e) Chairman
The members of each Advisory Board shall select a chairman from among the appointed
members.
(f) Executive director; professional and clerical
staff; administrative support services and facilities
The Secretary shall, after consultation with
and consideration of the recommendations of an
Advisory Board, provide the Advisory Board
with an executive director and one other professional staff member. In addition, the Secretary
shall, after consultation with and consideration
of the recommendations of the Advisory Board,
provide the Advisory Board with such additional
professional staff members, such clerical staff
members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines
are necessary for the Advisory Board to carry
out its functions.

§ 285c–4

(g) Meetings
Each Advisory Board shall meet at the call of
the chairman or upon request of the Director of
the Institute, but not less often than four times
a year.
(h) Functions of National Diabetes Advisory
Board and National Digestive Diseases Advisory Board
The National Diabetes Advisory Board and the
National Digestive Diseases Advisory Board
shall—
(1) review and evaluate the implementation
of the plan (referred to in section 285c–7 of this
title) respecting the diseases with respect to
which the Advisory Board was established and
periodically update the plan to ensure its continuing relevance;
(2) for the purpose of assuring the most effective use and organization of resources respecting such diseases, advise and make recommendations to the Congress, the Secretary,
the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies related to Federal agencies involved in the
implementation of such plan, the coordinating
committee for such diseases, and with key
non-Federal entities involved in activities affecting the control of such diseases.
(i) Subcommittees; establishment and membership
In carrying out its functions, each Advisory
Board may establish subcommittees, convene
workshops and conferences, and collect data.
Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to
enable them to carry out their activities.
(j) Termination of predecessor boards; time within which to appoint members
The National Diabetes Advisory Board and the
National Digestive Diseases Advisory Board in
existence on November 20, 1985, shall terminate
upon the appointment of a successor Board
under subsection (a) of this section. The Secretary shall make appointments to the Advisory
Boards established under subsection (a) of this
section before the expiration of 90 days after November 20, 1985. The members of the Boards in
existence on November 20, 1985, may be appointed, in accordance with subsections (b) and
(d) of this section, to the Boards established
under subsection (a) of this section for diabetes
and digestive diseases, except that at least onehalf of the members of the National Diabetes
Advisory Board in existence on November 20,
1985, shall be appointed to the National Diabetes
Advisory Board first established under subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, § 430, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 844; amended
Pub. L. 100–607, title I, § 131, Nov. 4, 1988, 102
Stat. 3056; Pub. L. 102–405, title III, § 302(e)(1),
Oct. 9, 1992, 106 Stat. 1985; Pub. L. 102–531, title

§ 285c–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

III, § 312(d)(6), Oct. 27, 1992, 106 Stat. 3504; Pub. L.
103–43, title XX, § 2008(b)(5), June 10, 1993, 107
Stat. 211; Pub. L. 105–362, title VI, § 601(a)(1)(C),
Nov. 10, 1998, 112 Stat. 3285; Pub. L. 110–154,
§ 1(b)(6), Dec. 21, 2007, 121 Stat. 1827.)
AMENDMENTS
2007—Subsec. (b)(2)(B). Pub. L. 110–154 substituted
‘‘Eunice Kennedy Shriver National Institute of Child
Health and Human Development’’ for ‘‘National Institute of Child Health and Human Development’’.
1998—Subsecs. (j), (k). Pub. L. 105–362 redesignated
subsec. (k) as (j) and struck out former subsec. (j)
which read as follows: ‘‘Each Advisory Board shall prepare an annual report for the Secretary which—
‘‘(1) describes the Advisory Board’s activities in the
fiscal year for which the report is made;
‘‘(2) describes and evaluates the progress made in
such fiscal year in research, treatment, education,
and training with respect to the diseases with respect
to which the Advisory Board was established;
‘‘(3) summarizes and analyzes expenditures made by
the Federal Government for activities respecting
such diseases in such fiscal year; and
‘‘(4) contains the Advisory Board’s recommendations (if any) for changes in the plan referred to in
section 285c–7 of this title.’’
1993—Subsec. (b)(2)(A)(i). Pub. L. 103–43 substituted
‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1992—Subsec. (b)(2)(A)(i). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–405 substituted ‘‘Under Secretary for
Health’’ for ‘‘Chief Medical Director’’.
1988—Subsecs. (k), (l). Pub. L. 100–607 redesignated
subsec. (l) as (k) and struck out former subsec. (k)
which read as follows: ‘‘Each Advisory Board shall expire on September 30, 1988.’’

Page 552

centers for research and training in diabetes
mellitus and related endocrine and metabolic
diseases. Each center developed or expanded
under this subsection shall—
(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research
and training qualifications as may be prescribed by the Secretary; and
(B) conduct—
(i) research in the diagnosis and treatment
of diabetes mellitus and related endocrine
and metabolic diseases and the complications resulting from such diseases;
(ii) training programs for physicians and
allied health personnel in current methods
of diagnosis and treatment of such diseases
and complications, and in research in diabetes; and
(iii) information programs for physicians
and allied health personnel who provide primary care for patients with such diseases or
complications.

§ 285c–5. Research and training centers; development or expansion

(2) A center may use funds provided under
paragraph (1) to provide stipends for nurses and
allied health professionals enrolled in research
training programs described in paragraph
(1)(B)(ii).
(b) Digestive diseases and related functional,
congenital, metabolic disorders, and normal
development of digestive tract
Consistent with applicable recommendations
of the National Digestive Diseases Advisory
Board, the Director shall provide for the development or substantial expansion of centers for
research in digestive diseases and related functional, congenital, metabolic disorders, and normal development of the digestive tract. Each
center developed or expanded under this subsection—
(1) shall utilize the facilities of a single institution, or be formed from a consortium of
cooperating institutions, meeting such research qualifications as may be prescribed by
the Secretary;
(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early
detection, prevention, control, and treatment
of digestive diseases and nutritional disorders
and related functional, congenital, or metabolic complications resulting from such diseases or disorders;
(3) shall encourage research into and programs for—
(A) providing information for patients
with such diseases and the families of such
patients, physicians and others who care for
such patients, and the general public;
(B) model programs for cost effective and
preventive patient care; and
(C) training physicians and scientists in
research on such diseases, disorders, and
complications; and

(a) Diabetes mellitus and related endocrine and
metabolic diseases
(1) Consistent with applicable recommendations of the National Commission on Diabetes,
the Director of the Institute shall provide for
the development or substantial expansion of

(4) may perform research and participate in
epidemiological studies and data collection
relevant to digestive diseases and disorders
and disseminate such research, studies, and
data to the health care profession and to the
public.

TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463,
Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Kidney and urologic diseases
The Director shall provide for the development or substantial expansion of centers for research in kidney and urologic diseases. Each
center developed or expanded under this subsection—
(1) shall utilize the facilities of a single institution, or be formed from a consortium of
cooperating institutions, meeting such research qualifications as may be prescribed by
the Secretary;
(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early
detection, prevention, control, and treatment
of kidney and urologic diseases;
(3) shall encourage research into and programs for—
(A) providing information for patients
with such diseases, disorders, and complications and the families of such patients, physicians and others who care for such patients, and the general public;
(B) model programs for cost effective and
preventive patient care; and
(C) training physicians and scientists in
research on such diseases; and
(4) may perform research and participate in
epidemiological studies and data collection
relevant to kidney and urologic diseases in
order to disseminate such research, studies,
and data to the health care profession and to
the public.
(d) Nutritional disorders
(1) The Director of the Institute shall, subject
to the extent of amounts made available in appropriations Acts, provide for the development
or substantial expansion of centers for research
and training regarding nutritional disorders, including obesity.
(2) The Director of the Institute shall carry
out paragraph (1) in collaboration with the Director of the National Cancer Institute and with
the Directors of such other agencies of the National Institutes of Health as the Director of
NIH determines to be appropriate.
(3) Each center developed or expanded under
paragraph (1) shall—
(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research
and training qualifications as may be prescribed by the Director;
(B) conduct basic and clinical research into
the cause, diagnosis, early detection, prevention, control and treatment of nutritional disorders, including obesity and the impact of nutrition and diet on child development;
(C) conduct training programs for physicians
and allied health professionals in current
methods of diagnosis and treatment of such
diseases and complications, and in research in
such disorders; and
(D) conduct information programs for physicians and allied health professionals who provide primary care for patients with such disorders or complications.
(e) Geographic distribution; period of support,
additional periods
Insofar as practicable, centers developed or expanded under this section should be geographi-

§ 285c–7

cally dispersed throughout the United States
and in environments with proven research capabilities. Support of a center under this section
may be for a period of not to exceed five years
and such period may be extended by the Director of the Institute for additional periods of not
more than five years each if the operations of
such center have been reviewed by an appropriate technical and scientific peer review group
established by the Director and if such group
has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, § 431, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 846; amended
Pub. L. 103–43, title VI, § 601(b), June 10, 1993, 107
Stat. 161.)
AMENDMENTS
1993—Subsecs. (d), (e). Pub. L. 103–43 added subsec. (d)
and redesignated former subsec. (d) as (e).

§ 285c–6. Advisory council subcommittees
There are established within the advisory
council for the Institute appointed under section
284a of this title a subcommittee on diabetes and
endocrine and metabolic diseases, a subcommittee on digestive diseases and nutrition, and a
subcommittee on kidney, urologic, and hematologic diseases. The subcommittees shall be composed of members of the advisory council who
are outstanding in the diagnosis, prevention,
and treatment of the diseases for which the subcommittees are established and members of the
advisory council who are leaders in the fields of
education and public affairs. The subcommittees
are authorized to review applications made to
the Director of the Institute for grants for research and training projects relating to the diagnosis, prevention, and treatment of the diseases for which the subcommittees are established and shall recommend to the advisory
council those applications and contracts that
the subcommittees determine will best carry
out the purposes of the Institute. The subcommittees shall also review and evaluate the
diabetes and endocrine and metabolic diseases,
digestive diseases and nutrition, and kidney,
urologic, and hematologic diseases programs of
the Institute and recommend to the advisory
council such changes in the administration of
such programs as the subcommittees determine
are necessary.
(July 1, 1944, ch. 373, title IV, § 432, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 847.)
§ 285c–7. Biennial report
The Director of the Institute shall prepare for
inclusion in the biennial report made under section 284b 1 of this title a description of the Institute’s activities—
(1) under the current diabetes plan under the
National Diabetes Mellitus Research and Education Act; and
(2) under the current digestive diseases plan
formulated under the Arthritis, Diabetes, and
Digestive Diseases Amendments of 1976.
The description submitted by the Director shall
include an evaluation of the activities of the
1 See

References in Text note below.

§ 285c–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE

centers supported under section 285c–5 of this
title.
(July 1, 1944, ch. 373, title IV, § 433, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 848.)
REFERENCES IN TEXT
Section 284b of this title, referred to in text, was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C), Jan. 15,
2007, 120 Stat. 3693.
The National Diabetes Mellitus Research and Education Act, referred to in par. (1), is Pub. L. 93–354, July
23, 1974, 88 Stat. 373, as amended, which enacted former
sections 289c–1a, 289c–2, and 289c–3 of this title, amended section 247b and former section 289c–1 of this title,
and enacted provisions formerly set out as notes under
section 289c–2 of this title. For complete classification
of this Act to the Code, see Short Title of 1974 Amendments note set out under section 201 of this title and
Tables.
The Arthritis, Diabetes, and Digestive Diseases
Amendments of 1976, referred to in par. (2), is Pub. L.
94–562, Oct. 19, 1976, 90 Stat. 2645, as amended, which enacted former sections 289c–3a, 289c–7, and 289c–8 of this
title, amended former sections 289c–2, 289c–5, and 289c–6
of this title, and enacted provisions formerly set out as
notes under sections 289a, 289c–3a, and 289c–7 of this
title. For complete classification of this Act to the
Code, see Short Title of 1976 Amendments note set out
under section 201 of this title and Tables.

§ 285c–8. Nutritional disorders program
(a) Establishment
The Director of the Institute, in consultation
with the Director of NIH, shall establish a program of conducting and supporting research,
training, health information dissemination, and
other activities with respect to nutritional disorders, including obesity.
(b) Support of activities
In carrying out the program established under
subsection (a) of this section, the Director of the
Institute shall conduct and support each of the
activities described in such subsection.
(c) Dissemination of information
In carrying out the program established under
subsection (a) of this section, the Director of the
Institute shall carry out activities to facilitate
and enhance knowledge and understanding of
nutritional disorders, including obesity, on the
part of health professionals, patients, and the
public through the effective dissemination of information.
(July 1, 1944, ch. 373, title IV, § 434, as added Pub.
L. 103–43, title VI, § 601[(a)], June 10, 1993, 107
Stat. 161.)
§ 285c–9. Juvenile diabetes
(a) Long-term epidemiology studies
The Director of the Institute shall conduct or
support long-term epidemiology studies in
which individuals with or at risk for type 1, or
juvenile, diabetes are followed for 10 years or
more. Such studies shall investigate the causes
and characteristics of the disease and its complications.
(b) Clinical trial infrastructure/innovative treatments for juvenile diabetes
The Secretary, acting through the Director of
the National Institutes of Health, shall support

Page 554

regional clinical research centers for the prevention, detection, treatment, and cure of juvenile
diabetes.
(c) Prevention of type 1 diabetes
The Secretary, acting through the appropriate
agencies, shall provide for a national effort to
prevent type 1 diabetes. Such effort shall provide for a combination of increased efforts in research and development of prevention strategies, including consideration of vaccine development, coupled with appropriate ability to test
the effectiveness of such strategies in large clinical trials of children and young adults.
(July 1, 1944, ch. 373, title IV, § 434A, as added
Pub. L. 106–310, div. A, title IV, § 402, Oct. 17,
2000, 114 Stat. 1112; amended Pub. L. 109–482, title
I, § 103(b)(21), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2001 through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 4—NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN DISEASES

§ 285d. Purpose of Institute
The general purpose of the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (hereafter in this subpart referred to as
the ‘‘Institute’’) is the conduct and support of
research and training, the dissemination of
health information, and other programs with respect to arthritis and musculoskeletal and skin
diseases (including sports-related disorders),
with particular attention to the effect of these
diseases on children.
(July 1, 1944, ch. 373, title IV, § 435, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 848; amended
Pub. L. 103–43, title VII, § 701(a), June 10, 1993, 107
Stat. 162.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘(including sports-related disorders), with particular attention to the effect
of these diseases on children’’ for ‘‘, including sportsrelated disorders’’.

§ 285d–1. National arthritis and musculoskeletal
and skin diseases program
(a) Plan to expand, intensify, and coordinate activities; submission; periodic review and revision
The Director of the Institute, with the advice
of the Institute’s advisory council, shall prepare
and transmit to the Director of NIH a plan for
a national arthritis and musculoskeletal and
skin diseases program to expand, intensify, and
coordinate the activities of the Institute respecting arthritis and musculoskeletal and skin
diseases. The plan shall include such comments
and recommendations as the Director of the In-

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stitute determines appropriate. The plan shall
place particular emphasis upon expanding research into better understanding the causes and
the development of effective treatments for arthritis affecting children. The Director of the
Institute shall periodically review and revise
such plan and shall transmit any revisions of
such plan to the Director of NIH.
(b) Coordination of activities with other national
research institutes; minimum activities
under program
Activities under the national arthritis and
musculoskeletal and skin diseases program shall
be coordinated with the other national research
institutes to the extent that such institutes
have responsibilities respecting arthritis and
musculoskeletal and skin diseases, and shall, at
least, provide for—
(1) investigation into the epidemiology, etiology, and prevention of all forms of arthritis
and musculoskeletal and skin diseases, including sports-related disorders, primarily through
the support of basic research in such areas as
immunology, genetics, biochemistry, microbiology, physiology, bioengineering, and any
other scientific discipline which can contribute important knowledge to the treatment
and understanding of arthritis and musculoskeletal and skin diseases;
(2) research into the development, trial, and
evaluation of techniques, drugs, and devices
used in the diagnosis, treatment, including
medical rehabilitation, and prevention of arthritis and musculoskeletal and skin diseases;
(3) research on the refinement, development,
and evaluation of technological devices that
will replace or be a substitute for damaged
bone, muscle, and joints and other supporting
structures;
(4) the establishment of mechanisms to monitor the causes of athletic injuries and identify
ways of preventing such injuries on scholastic
athletic fields; and
(5) research into the causes of arthritis affecting children and the development, trial,
and evaluation of techniques, drugs and devices used in the diagnosis, treatment (including medical rehabilitation), and prevention of
arthritis in children.
(c) Program to be carried out in accordance with
plan
The Director of the Institute shall carry out
the national arthritis and musculoskeletal and
skin diseases program in accordance with the
plan prepared under subsection (a) of this section and any revisions of such plan made under
such subsection.
(July 1, 1944, ch. 373, title IV, § 436, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 848; amended
Pub. L. 100–607, title I, § 136, Nov. 4, 1988, 102
Stat. 3056; Pub. L. 103–43, title VII, § 701(b), June
10, 1993, 107 Stat. 162.)
AMENDMENTS
1993—Subsec. (a). Pub. L. 103–43, § 701(b)(1), inserted
after second sentence ‘‘The plan shall place particular
emphasis upon expanding research into better understanding the causes and the development of effective
treatments for arthritis affecting children.’’
Subsec. (b)(5). Pub. L. 103–43, § 701(b)(2), added par. (5).

§ 285d–4

1988—Pub. L. 100–607 inserted ‘‘and skin’’ after ‘‘musculoskeletal’’ in section catchline and wherever appearing in text.

§ 285d–2. Research and training
The Director of the Institute shall—
(1) carry out programs of support for research and training (other than training for
which Ruth L. Kirschstein National Research
Service Awards may be made under section 288
of this title) in the diagnosis, prevention, and
treatment of arthritis and musculoskeletal
and skin diseases, including support for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary research programs; and
(2) establish programs of evaluation, planning, and dissemination of knowledge related
to such research and training.
(July 1, 1944, ch. 373, title IV, § 437, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 849; amended
Pub. L. 107–206, title I, § 804(c), Aug. 2, 2002, 116
Stat. 874.)
AMENDMENTS
2002—Par. (1). Pub. L. 107–206 substituted ‘‘Ruth L.
Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’.

§ 285d–3. Data system and information clearinghouse
(a) The Director of the Institute shall establish the National Arthritis and Musculoskeletal
and Skin Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations
with arthritis and musculoskeletal and skin diseases, including where possible, data involving
general populations for the purpose of detection
of individuals with a risk of developing arthritis
and musculoskeletal and skin diseases.
(b) The Director of the Institute shall establish the National Arthritis and Musculoskeletal
and Skin Diseases Information Clearinghouse to
facilitate and enhance, through the effective dissemination of information, knowledge and understanding of arthritis and musculoskeletal
and skin diseases, including juvenile arthritis
and related conditions, by health professionals,
patients, and the public.
(July 1, 1944, ch. 373, title IV, § 438, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 849; amended
Pub. L. 106–310, div. A, title III, § 302, Oct. 17,
2000, 114 Stat. 1111.)
AMENDMENTS
2000—Subsec. (b). Pub. L. 106–310 inserted ‘‘, including
juvenile arthritis and related conditions,’’ after ‘‘skin
diseases’’.

§ 285d–4. Interagency coordinating committees
(a) Establishment and purpose
For the purpose of—
(1) better coordination of the research activities of all the national research institutes
relating to arthritis, musculoskeletal diseases,
and skin diseases, including sports-related disorders; and
(2) coordinating the aspects of all Federal
health programs and activities relating to ar-

§ 285d–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

thritis, musculoskeletal diseases, and skin diseases in order to assure the adequacy and
technical soundness of such programs and activities and in order to provide for the full
communication and exchange of information
necessary to maintain adequate coordination
of such programs and activities,
the Secretary shall establish an Arthritis and
Musculoskeletal Diseases Interagency Coordinating Committee and a Skin Diseases Interagency Coordinating Committee (hereafter in
this section individually referred to as a ‘‘Committee’’).
(b) Membership; chairman; meetings
Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research regarding the diseases with respect to which the Committee is established, the Under Secretary for
Health of the Department of Veterans Affairs,
and the Assistant Secretary of Defense for
Health Affairs (or the designees of such officers),
and representatives of all other Federal departments and agencies (as determined by the Secretary) whose programs involve health functions
or responsibilities relevant to arthritis and musculoskeletal diseases or skin diseases, as the
case may be. Each Committee shall be chaired
by the Director of NIH (or the designee of the
Director). Each Committee shall meet at the
call of the chairman, but not less often than
four times a year.
(July 1, 1944, ch. 373, title IV, § 439, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 849; amended
Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992,
106 Stat. 1985; Pub. L. 103–43, title XX,
§ 2008(b)(6), June 10, 1993, 107 Stat. 211; Pub. L.
105–362, title VI, § 601(a)(1)(D), Nov. 10, 1998, 112
Stat. 3285.)
AMENDMENTS
1998—Subsec. (c). Pub. L. 105–362 struck out subsec.
(c) which read as follows: ‘‘Not later than 120 days after
the end of each fiscal year, each Committee shall prepare and transmit to the Secretary, the Director of
NIH, the Director of the Institute, and the advisory
council for the Institute a report detailing the activities of the Committee in such fiscal year in carrying
out paragraphs (1) and (2) of subsection (a) of this section.’’
1993—Subsec. (b). Pub. L. 103–43 substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1992—Subsec. (b). Pub. L. 102–405 substituted ‘‘Under
Secretary for Health’’ for ‘‘Chief Medical Director’’.

§ 285d–5. Arthritis and musculoskeletal diseases
demonstration projects
(a) Grants for establishment and support
The Director of the Institute may make grants
to public and private nonprofit entities to establish and support projects for the development
and demonstration of methods for screening, detection, and referral for treatment of arthritis
and musculoskeletal diseases and for the dissemination of information on such methods to
the health and allied health professions. Activities under such projects shall be coordinated
with Federal, State, local, and regional health
agencies, centers assisted under section 285d–6 of

Page 556

this title, and the data system established under
subsection (c) of this section.
(b) Programs included
Projects supported under this section shall include—
(1) programs which emphasize the development and demonstration of new and improved
methods of screening and early detection, referral for treatment, and diagnosis of individuals with a risk of developing arthritis and
musculoskeletal diseases;
(2) programs which emphasize the development and demonstration of new and improved
methods for patient referral from local hospitals and physicians to appropriate centers
for early diagnosis and treatment;
(3) programs which emphasize the development and demonstration of new and improved
means of standardizing patient data and recordkeeping;
(4) programs which emphasize the development and demonstration of new and improved
methods of dissemination of knowledge about
the programs, methods, and means referred to
in paragraphs (1), (2), and (3) of this subsection
to health and allied health professionals;
(5) programs which emphasize the development and demonstration of new and improved
methods for the dissemination to the general
public of information—
(A) on the importance of early detection of
arthritis and musculoskeletal diseases, of
seeking prompt treatment, and of following
an appropriate regimen; and
(B) to discourage the promotion and use of
unapproved and ineffective diagnostic, preventive treatment, and control methods for
arthritis and unapproved and ineffective
drugs and devices for arthritis and musculoskeletal diseases; and
(6) projects for investigation into the epidemiology of all forms and aspects of arthritis
and musculoskeletal diseases, including investigations into the social, environmental, behavioral, nutritional, and genetic determinants and influences involved in the epidemiology of arthritis and musculoskeletal diseases.
(c) Standardization of patient data and recordkeeping
The Director shall provide for the standardization of patient data and recordkeeping for the
collection, storage, analysis, retrieval, and dissemination of such data in cooperation with
projects assisted under this section, centers assisted under section 285d–6 of this title, and
other persons engaged in arthritis and musculoskeletal disease programs.
(July 1, 1944, ch. 373, title IV, § 440, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 850.)
§ 285d–6. Multipurpose arthritis and musculoskeletal diseases centers
(a) Development, modernization, and operation
The Director of the Institute shall, after consultation with the advisory council for the Institute, provide for the development, modernization, and operation (including staffing and other

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operating costs such as the costs of patient care
required for research) of new and existing centers for arthritis and musculoskeletal diseases.
For purposes of this section, the term ‘‘modernization’’ means the alteration, remodeling,
improvement, expansion, and repair of existing
buildings and the provision of equipment for
such buildings to the extent necessary to make
them suitable for use as centers described in the
preceding sentence.
(b) Duties and functions
Each center assisted under this section shall—
(1)(A) use the facilities of a single institution or a consortium of cooperating institutions, and (B) meet such qualifications as may
be prescribed by the Secretary; and
(2) conduct—
(A) basic and clinical research into the
cause, diagnosis, early detection, prevention, control, and treatment of and rehabilitation from arthritis and musculoskeletal
diseases and complications resulting from
arthritis and musculoskeletal diseases, including research into implantable biomaterials and biomechanical and other orthopedic procedures;
(B) training programs for physicians, scientists, and other health and allied health
professionals;
(C) information and continuing education
programs for physicians and other health
and allied health professionals who provide
care for patients with arthritis and musculoskeletal diseases; and
(D) programs for the dissemination to the
general public of information—
(i) on the importance of early detection
of arthritis and musculoskeletal diseases,
of seeking prompt treatment, and of following an appropriate regimen; and
(ii) to discourage the promotion and use
of unapproved and ineffective diagnostic,
preventive, treatment, and control methods and unapproved and ineffective drugs
and devices.
A center may use funds provided under subsection (a) of this section to provide stipends for
health professionals enrolled in training programs described in paragraph (2)(B).
(c) Optional programs
Each center assisted under this section may
conduct programs to—
(1) establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases;
(2) disseminate the results of research,
screening, and other activities, and develop
means of standardizing patient data and recordkeeping; and
(3) develop community consultative services
to facilitate the referral of patients to centers
for treatment.
(d) Geographical distribution
The Director of the Institute shall, insofar as
practicable, provide for an equitable geographical distribution of centers assisted under this
section. The Director shall give appropriate consideration to the need for centers especially

§ 285d–6a

suited to meeting the needs of children affected
by arthritis and musculoskeletal diseases.
(e) Period of support; additional periods
Support of a center under this section may be
for a period of not to exceed five years. Such period may be extended by the Director of the Institute for one or more additional periods of not
more than five years if the operations of such
center have been reviewed by an appropriate
technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period
should be extended.
(f) Treatment and rehabilitation of children
Not later than October 1, 1993, the Director
shall establish a multipurpose arthritis and
musculoskeletal disease center for the purpose
of expanding the level of research into the
cause, diagnosis, early detection, prevention,
control, and treatment of, and rehabilitation of
children with arthritis and musculoskeletal diseases.
(July 1, 1944, ch. 373, title IV, § 441, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 851; amended
Pub. L. 100–607, title I, § 137, Nov. 4, 1988, 102
Stat. 3056; Pub. L. 103–43, title VII, § 701(c), June
10, 1993, 107 Stat. 162.)
AMENDMENTS
1993—Subsec. (f). Pub. L. 103–43 added subsec. (f).
1988—Subsec. (b)(2)(A). Pub. L. 100–607 inserted ‘‘and
rehabilitation from’’ after ‘‘and treatment of’’.

§ 285d–6a. Lupus
(a) In general
The Director of the Institute shall expand and
intensify research and related activities of the
Institute with respect to lupus.
(b) Coordination with other institutes
The Director of the Institute shall coordinate
the activities of the Director under subsection
(a) of this section with similar activities conducted by the other national research institutes
and agencies of the National Institutes of
Health to the extent that such Institutes and
agencies have responsibilities that are related to
lupus.
(c) Programs for lupus
In carrying out subsection (a) of this section,
the Director of the Institute shall conduct or
support research to expand the understanding of
the causes of, and to find a cure for, lupus. Activities under such subsection shall include conducting and supporting the following:
(1) Research to determine the reasons underlying the elevated prevalence of lupus in
women, including African-American women.
(2) Basic research concerning the etiology
and causes of the disease.
(3) Epidemiological studies to address the
frequency and natural history of the disease
and the differences among the sexes and
among racial and ethnic groups with respect
to the disease.
(4) The development of improved diagnostic
techniques.
(5) Clinical research for the development and
evaluation of new treatments, including new
biological agents.

§ 285d–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) Information and education programs for
health care professionals and the public.
(July 1, 1944, ch. 373, title IV, § 441A, as added
Pub. L. 106–505, title V, § 511, Nov. 13, 2000, 114
Stat. 2342; amended Pub. L. 109–482, title I,
§ 103(b)(22), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2001 through 2003.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
FINDINGS
Pub. L. 106–505, title V, § 502, Nov. 13, 2000, 114 Stat.
2342, provided that: ‘‘The Congress finds that—
‘‘(1) lupus is a serious, complex, inflammatory,
autoimmune disease of particular concern to women;
‘‘(2) lupus affects women nine times more often
than men;
‘‘(3) there are three main types of lupus: systemic
lupus, a serious form of the disease that affects many
parts of the body; discoid lupus, a form of the disease
that affects mainly the skin; and drug-induced lupus
caused by certain medications;
‘‘(4) lupus can be fatal if not detected and treated
early;
‘‘(5) the disease can simultaneously affect various
areas of the body, such as the skin, joints, kidneys,
and brain, and can be difficult to diagnose because
the symptoms of lupus are similar to those of many
other diseases;
‘‘(6) lupus disproportionately affects African-American women, as the prevalence of the disease among
such women is three times the prevalence among
white women, and an estimated 1 in 250 AfricanAmerican women between the ages of 15 and 65 develops the disease;
‘‘(7) it has been estimated that between 1,400,000 and
2,000,000 Americans have been diagnosed with the disease, and that many more have undiagnosed cases;
‘‘(8) current treatments for the disease can be effective, but may lead to damaging side effects;
‘‘(9) many victims of the disease suffer debilitating
pain and fatigue, making it difficult to maintain employment and lead normal lives; and
‘‘(10) in fiscal year 1996, the amount allocated by
the National Institutes of Health for research on
lupus was $33,000,000, which is less than one-half of 1
percent of the budget for such Institutes.’’

§ 285d–7. Advisory Board
(a) Establishment
The Secretary shall establish in the Institute
the National Arthritis and Musculoskeletal and
Skin Diseases Advisory Board (hereafter in this
section referred to as the ‘‘Advisory Board’’).
(b) Membership; ex officio members
The Advisory Board shall be composed of
twenty appointed members and nonvoting, ex
officio members, as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who
are scientists, physicians, and other health
professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines rel-

Page 558

evant to arthritis, musculoskeletal diseases,
and skin diseases; and
(B) eight members from the general public
who are knowledgeable with respect to such
diseases, including one member who is a person who has such a disease, one person who
is the parent of an adult with such a disease,
and two members who are parents of children with arthritis.
Of the appointed members at least five shall
by virtue of training or experience be knowledgeable in health education, nursing, data
systems, public information, or community
program development.
(2) The following shall be ex officio members
of the Advisory Board:
(A) the Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute of Arthritis and Musculoskeletal
and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the
Under Secretary for Health of the Department of Veterans Affairs, and the Assistant
Secretary of Defense for Health Affairs (or
the designees of such officers), and
(B) such other officers and employees of
the United States as the Secretary determines necessary for the Advisory Board to
carry out its functions.
(c) Compensation
Members of the Advisory Board who are officers or employees of the Federal Government
shall serve as members of the Advisory Board
without compensation in addition to that received in their regular public employment.
Other members of the Advisory Board shall receive compensation at rates not to exceed the
daily equivalent of the annual rate in effect for
grade GS–18 of the General Schedule for each
day (including traveltime) they are engaged in
the performance of their duties as members of
the Advisory Board.
(d) Term of office; vacancy
The term of office of an appointed member of
the Advisory Board is four years. Any member
appointed to fill a vacancy for an unexpired
term shall be appointed for the remainder of
such term. A member may serve after the expiration of the member’s term until a successor
has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90
days after the date the vacancy occurred.
(e) Chairman
The members of the Advisory Board shall select a chairman from among the appointed
members.
(f) Executive director, professional and clerical
staff; administrative support services and facilities
The Secretary shall, after consultation with
and consideration of the recommendations of
the Advisory Board, provide the Advisory Board
with an executive director and one other professional staff member. In addition, the Secretary
shall, after consultation with and consideration
of the recommendations of the Advisory Board,
provide the Advisory Board with such additional

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professional staff members, such clerical staff
members, and (through contracts or other arrangements) with such administrative support
services and facilities, such information, and
such services of consultants, as the Secretary
determines are necessary for the Advisory Board
to carry out its functions.
(g) Meetings
The Advisory Board shall meet at the call of
the chairman or upon request of the Director of
the Institute, but not less often than four times
a year.
(h) Duties and functions
The Advisory Board shall—
(1) review and evaluate the implementation
of the plan prepared under section 285d–1(a) of
this title and periodically update the plan to
ensure its continuing relevance;
(2) for the purpose of assuring the most effective use and organization of resources respecting arthritis, musculoskeletal diseases
and skin diseases, advise and make recommendations to the Congress, the Secretary,
the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies for Federal agencies involved in the implementation of such plan, the interagency coordinating committees for such diseases established under section 285d–4 of this title, and
with key non-Federal entities involved in activities affecting the control of such diseases.
(i) Subcommittees; establishment and membership
In carrying out its functions, the Advisory
Board may establish subcommittees, convene
workshops and conferences, and collect data.
Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to
enable them to carry out their activities.
(j) Termination of predecessor board; time within which to appoint members
The National Arthritis Advisory Board in existence on November 20, 1985, shall terminate
upon the appointment of a successor Board
under subsection (a) of this section. The Secretary shall make appointments to the Advisory
Board established under subsection (a) of this
section before the expiration of 90 days after November 20, 1985. The member of the Board in existence on November 20, 1985, may be appointed,
in accordance with subsections (b) and (d) of this
section, to the Advisory Board established under
subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, § 442, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 852; amended
Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992,
106 Stat. 1985; Pub. L. 102–531, title III, § 312(d)(7),
Oct. 27, 1992, 106 Stat. 3504; Pub. L. 103–43, title
VII, § 701(d), title XX, § 2008(b)(7), June 10, 1993,
107 Stat. 162, 211; Pub. L. 109–482, title I,
§ 104(b)(1)(I), Jan. 15, 2007, 120 Stat. 3693.)

§ 285d–8

AMENDMENTS
2007—Subsecs. (j), (k). Pub. L. 109–482 redesignated
subsec. (k) as (j) and struck out former subsec. (j)
which required the Advisory Board to prepare an annual report for the Secretary and set out the subjects
for report.
1993—Subsec. (a). Pub. L. 103–43, § 701(d)(1), inserted
‘‘and Musculoskeletal and Skin Diseases’’ after ‘‘Arthritis’’.
Subsec. (b). Pub. L. 103–43, §§ 701(d)(2), 2008(b)(7), substituted ‘‘twenty’’ for ‘‘eighteen’’ in introductory provisions, ‘‘eight’’ for ‘‘six’’ and ‘‘including one member
who is a person who has such a disease, one person who
is the parent of an adult with such a disease, and two
members who are parents of children with arthritis’’
for ‘‘including at least one member who is a person who
has such a disease and one member who is a parent of
a person who has such a disease’’ in par. (1)(B), and
‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’ in par. (2)(A).
Subsec. (j)(5). Pub. L. 103–43, § 701(d)(3), added par. (5).
1992—Subsec. (b)(2)(A). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–405 substituted ‘‘Under Secretary for
Health’’ for ‘‘Chief Medical Director’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463,
Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 285d–8. Juvenile arthritis and related conditions
(a) Expansion and coordination of activities
The Director of the Institute, in coordination
with the Director of the National Institute of
Allergy and Infectious Diseases, shall expand
and intensify the programs of such Institutes
with respect to research and related activities
concerning juvenile arthritis and related conditions.
(b) Coordination
The Directors referred to in subsection (a) of
this section shall jointly coordinate the pro-

§ 285e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

grams referred to in such subsection and consult
with the Arthritis and Musculoskeletal Diseases
Interagency Coordinating Committee.
(July 1, 1944, ch. 373, title IV, § 442A, as added
Pub. L. 106–310, div. A, title III, § 301(a), Oct. 17,
2000, 114 Stat. 1111; amended Pub. L. 109–482, title
I, § 103(b)(23), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (c). Pub. L. 109–482 struck out heading
and text of subsec. (c). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2001 through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 5—NATIONAL INSTITUTE ON AGING

§ 285e. Purpose of Institute
The general purpose of the National Institute
on Aging (hereafter in this subpart referred to as
the ‘‘Institute’’) is the conduct and support of
biomedical, social, and behavioral research,
training, health information dissemination, and
other programs with respect to the aging process and the diseases and other special problems
and needs of the aged.
(July 1, 1944, ch. 373, title IV, § 443, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 854.)
STUDY OF MALNUTRITION IN ELDERLY
Pub. L. 103–43, title XIX, § 1902, June 10, 1993, 107 Stat.
201, directed Secretary of Health and Human Services,
acting through National Institute on Aging, to conduct
a 3-year study on health benefits and cost-effectiveness
of nutrition screening and intervention activities of the
elderly, and a 3-year study to determine extent of malnutrition in elderly individuals in hospitals and longterm care facilities and in elderly individuals who are
living independently, provided for creation of advisory
panel to oversee studies, provided for submission to
Congress of reports containing findings of such studies,
and provided for termination of advisory panel 3 years
after June 10, 1993.
STUDY OF PERSONNEL FOR HEALTH NEEDS OF ELDERLY
Section 8 of Pub. L. 99–158 directed Secretary to conduct a study on the adequacy and availability of personnel to meet the current and projected health needs
(including needs for home and community-based care)
of elderly Americans through the year 2020, and report
the results of the study, with recommendations, to
Congress by Mar. 1, 1987.

§ 285e–1. Special functions
(a) Education and training of adequate numbers
of personnel
In carrying out the training responsibilities
under this chapter or any other Act for health
and allied health professions personnel, the Secretary shall take appropriate steps to insure the
education and training of adequate numbers of
allied health, nursing, and paramedical personnel in the field of health care for the aged.
(b) Scientific studies
The Director of the Institute shall conduct
scientific studies to measure the impact on the

Page 560

biological, medical, social, and psychological aspects of aging of programs and activities assisted or conducted by the Department of Health
and Human Services.
(c) Public information and education programs
The Director of the Institute shall carry out
public information and education programs designed to disseminate as widely as possible the
findings of research sponsored by the Institute,
other relevant aging research and studies, and
other information about the process of aging
which may assist elderly and near-elderly persons in dealing with, and all Americans in understanding, the problems and processes associated with growing older.
(d) Grants for research relating to Alzheimer’s
Disease
The Director of the Institute shall make
grants to public and private nonprofit institutions to conduct research relating to Alzheimer’s Disease.
(July 1, 1944, ch. 373, title IV, § 444, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 854.)
§ 285e–2. Alzheimer’s Disease centers
(a) Cooperative agreements and grants for establishing and supporting
(1) The Director of the Institute may enter
into cooperative agreements with and make
grants to public or private nonprofit entities
(including university medical centers) to pay all
or part of the cost of planning, establishing, or
strengthening, and providing basic operating
support (including staffing) for centers for basic
and clinical research (including multidisciplinary research) into, training in, and demonstration of advanced diagnostic, prevention,
and treatment methods for Alzheimer’s disease.
(2) A cooperative agreement or grant under
paragraph (1) shall be entered into in accordance
with policies established by the Director of NIH
and after consultation with the Institute’s advisory council.
(b) Use of Federal payments under cooperative
agreement or grant
(1) Federal payments made under a cooperative agreement or grant under subsection (a) of
this section may, with respect to Alzheimer’s
disease, be used for—
(A) diagnostic examinations, patient assessments, patient care costs, and other costs necessary for conducting research;
(B) training, including training for allied
health professionals;
(C) diagnostic and treatment clinics designed to meet the special needs of minority
and rural populations and other underserved
populations;
(D) activities to educate the public; and
(E) the dissemination of information.
(2) For purposes of paragraph (1), the term
‘‘training’’ does not include research training
for which Ruth L. Kirschstein National Research Service Awards may be provided under
section 288 of this title.
(c) Support period; additional periods
Support of a center under subsection (a) of
this section may be for a period of not to exceed

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five years. Such period may be extended by the
Director for additional periods of not more than
five years each if the operations of such center
have been reviewed by an appropriate technical
and scientific peer review group established by
the Director and if such group has recommended
to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, § 445, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 855; amended
Pub. L. 101–557, title II, § 201, Nov. 15, 1990, 104
Stat. 2767; Pub. L. 107–206, title I, § 804(c), Aug. 2,
2002, 116 Stat. 874.)
AMENDMENTS
2002—Subsec. (b)(2). Pub. L. 107–206 substituted ‘‘Ruth
L. Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’.
1990—Subsec. (a)(1). Pub. L. 101–557, § 201(1), inserted
‘‘(including university medical centers)’’ after ‘‘nonprofit entities’’, ‘‘(including staffing)’’ after ‘‘operating
support’’, and ‘‘(including multidisciplinary research)’’
after ‘‘clinical research’’ and substituted ‘‘Alzheimer’s
disease’’ for ‘‘Alzheimer’s Disease’’.
Subsec. (b). Pub. L. 101–557, § 201(2), amended subsec.
(b) generally. Prior to amendment, subsec. (b) read as
follows: ‘‘Federal payments made under a cooperative
agreement or grant under subsection (a) of this section
may be used for—
‘‘(1) construction (notwithstanding any limitation
under section 289e of this title);
‘‘(2) staffing and other basic operating costs, including such patient care costs as are required for research;
‘‘(3) training, including training for allied health
professionals; and
‘‘(4) demonstration purposes.
As used in this subsection, the term ‘construction’ does
not include the acquisition of land, and the term ‘training’ does not include research training for which National Research Service Awards may be provided under
section 288 of this title.’’
ALZHEIMER’S DISEASE RESEARCH
Pub. L. 100–175, title III, Nov. 29, 1987, 101 Stat. 972,
provided that:
‘‘SEC. 301. REQUIREMENT FOR CLINICAL TRIALS.
‘‘(a) IN GENERAL.—The Director of the National Institute on Aging shall provide for the conduct of clinical
trials on the efficacy of the use of such promising
therapeutic agents as have been or may be discovered
and recommended for further scientific analysis by the
National Institute on Aging and the Food and Drug Administration to treat individuals with Alzheimer’s disease, to retard the progression of symptoms of Alzheimer’s disease, or to improve the functioning of individuals with such disease.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this title
shall be construed to affect adversely any research
being conducted as of the date of the enactment of this
Act [Nov. 29, 1987].
‘‘SEC. 302. AUTHORIZATION OF APPROPRIATIONS.
‘‘For the purpose of carrying out section 301, there is
authorized to be appropriated $2,000,000 for fiscal year
1988.’’
ALZHEIMER’S DISEASE REGISTRY
Section 12 of Pub. L. 99–158, which was formerly set
out as a note under this section, was renumbered section 445G of the Public Health Service Act by Pub. L.
103–43, title VIII, § 801(a), June 10, 1993, 107 Stat. 163, and
is classified to section 285e–9 of this title.

§ 285e–3

§ 285e–3. Claude D. Pepper Older Americans
Independence Centers
(a) Development and expansion of centers
The Director of the Institute shall enter into
cooperative agreements with, and make grants
to, public and private nonprofit entities for the
development or expansion of not less than 10
centers of excellence in geriatric research and
training of researchers. Each such center shall
be known as a Claude D. Pepper Older Americans Independence Center.
(b) Functions of centers
Each center developed or expanded under this
section shall—
(1) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research
and training qualifications as may be prescribed by the Director; and
(2) conduct—
(A) research into the aging processes and
into the diagnosis and treatment of diseases,
disorders, and complications related to
aging, including menopause, which research
includes research on such treatments, and
on medical devices and other medical interventions regarding such diseases, disorders,
and complications, that can assist individuals in avoiding institutionalization and
prolonged hospitalization and in otherwise
increasing the independence of the individuals; and
(B) programs to develop individuals capable of conducting research described in subparagraph (A).
(c) Geographic distribution of centers
In making cooperative agreements and grants
under this section for the development or expansion of centers, the Director of the Institute
shall ensure that, to the extent practicable, any
such centers are distributed equitably among
the principal geographic regions of the United
States.
(d) ‘‘Independence’’ defined
For purposes of this section, the term ‘‘independence’’, with respect to diseases, disorders,
and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of
daily living without assistance or supervision.
(July 1, 1944, ch. 373, title IV, § 445A, as added
Pub. L. 100–607, title I, § 141, Nov. 4, 1988, 102
Stat. 3056; amended Pub. L. 101–557, title II, § 202,
Nov. 15, 1990, 104 Stat. 2767.)
AMENDMENTS
1990—Pub. L. 101–557, § 202(a)(1), substituted ‘‘Claude
D. Pepper Older Americans Independence Centers’’ for
‘‘Centers of geriatric research and training’’ in section
catchline.
Subsec. (a). Pub. L. 101–557, § 202(a)(2), (b)(1)(A), inserted ‘‘not less than 10’’ before ‘‘centers of excellence’’
and inserted provision designating centers as Claude D.
Pepper Older Americans Independence Centers.
Subsec. (b)(2)(A). Pub. L. 101–557, § 202(b)(1)(B), inserted before semicolon at end ‘‘, including menopause,
which research includes research on such treatments,
and on medical devices and other medical interventions
regarding such diseases, disorders, and complications,

§ 285e–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals’’.
Subsec. (b)(2)(B). Pub. L. 101–557, § 202(b)(2), substituted ‘‘research described in subparagraph (A)’’ for
‘‘research concerning aging and concerning such diseases, disorders, and complications.’’
Subsec. (d). Pub. L. 101–557, § 202(c), added subsec. (d).

§ 285e–4. Awards for leadership and excellence in
Alzheimer’s disease and related dementias
(a) Senior researchers in biomedical research
The Director of the Institute shall make
awards to senior researchers who have made distinguished achievements in biomedical research
in areas relating to Alzheimer’s disease and related dementias. Awards under this section shall
be used by the recipients to support research in
areas relating to such disease and dementias,
and may be used by the recipients to train junior researchers who demonstrate exceptional
promise to conduct research in such areas.
(b) Eligible centers
The Director of the Institute may make
awards under this section to researchers at centers supported under section 285e–2 of this title
and to researchers at other public and nonprofit
private entities.
(c) Required recommendation
The Director of the Institute shall make
awards under this section only to researchers
who have been recommended for such awards by
the National Advisory Council on Aging.
(d) Selection procedures
The Director of the Institute shall establish
procedures for the selection of the recipients of
awards under this section.
(e) Term of award; renewal
Awards under this section shall be made for a
one-year period, and may be renewed for not
more than six additional consecutive one-year
periods.
(July 1, 1944, ch. 373, title IV, § 445B, formerly
Pub. L. 99–660, title IX, § 931, Nov. 14, 1986, 100
Stat. 3807; renumbered § 445B of act July 1, 1944;
amended Pub. L. 100–607, title I, § 142(a), (d)(1),
Nov. 4, 1988, 102 Stat. 3057.)
CODIFICATION
Section was formerly classified to section 11231 of
this title prior to renumbering by Pub. L. 100–607.
AMENDMENTS
1988—Pub. L. 100–607, § 142(a), renumbered section
11231 of this title as this section.
Subsec. (a). Pub. L. 100–607, § 142(d)(1)(A), substituted
‘‘the Institute’’ for ‘‘the National Institute on Aging’’.
Subsec. (b). Pub. L. 100–607, § 142(d)(1)(B), substituted
‘‘the Institute’’ for ‘‘the National Institute on Aging’’
and made technical amendment to reference to section
285e–2 of this title to correct reference to corresponding
provision of original act.
Subsecs. (c), (d). Pub. L. 100–607, § 142(d)(1)(C), substituted ‘‘the Institute’’ for ‘‘the National Institute on
Aging’’.
AVAILABILITY OF APPROPRIATIONS
Section 142(b) of Pub. L. 100–607 provided that: ‘‘With
respect to amounts made available in appropriation
Acts for the purpose of carrying out the programs

Page 562

transferred by subsection (a) to the Public Health Service Act [sections 285e–4 to 285e–8 of this title], such subsection may not be construed to affect the availability
of such funds for such purpose.’’

§ 285e–5. Research relevant to appropriate services for individuals with Alzheimer’s disease
and related dementias and their families
(a) Grants for research
The Director of the Institute shall conduct, or
make grants for the conduct of, research relevant to appropriate services for individuals
with Alzheimer’s disease and related dementias
and their families.
(b) Preparation of plan; contents; revision
(1) Within 6 months after November 14, 1986,
the Director of the Institute shall prepare and
transmit to the Chairman of the Council on Alzheimer’s Disease (in this section referred to as
the ‘‘Council’’) a plan for the research to be conducted under subsection (a) of this section. The
plan shall—
(A) provide for research concerning—
(i) the epidemiology of, and the identification of risk factors for, Alzheimer’s disease
and related dementias; and
(ii) the development and evaluation of reliable and valid multidimensional diagnostic
and assessment procedures and instruments;
and
(B) ensure that research carried out under
the plan is coordinated with, and uses, to the
maximum extent feasible, resources of, other
Federal programs relating to Alzheimer’s disease and related dementias, including centers
supported under section 285e–2 of this title,
centers supported by the National Institute of
Mental Health on the psychopathology of the
elderly, relevant activities of the Administration on Aging, other programs and centers involved in research on Alzheimer’s disease and
related dementias supported by the Department, and other programs relating to Alzheimer’s disease and related dementias which
are planned or conducted by Federal agencies
other than the Department, State or local
agencies, community organizations, or private
foundations.
(2) Within one year after transmitting the
plan required under paragraph (1), and annually
thereafter, the Director of the Institute shall
prepare and transmit to the Chairman of the
Council such revisions of such plan as the Director considers appropriate.
(c) Consultation for preparation and revision of
plan
In preparing and revising the plan required by
subsection (b) of this section, the Director of the
Institute shall consult with the Chairman of the
Council and the heads of agencies within the Department.
(d) Grants for promoting independence and preventing secondary disabilities
the 1 Director of the Institute may develop, or
make grants to develop—
(1) model techniques to—
1 So

in original. Probably should be capitalized.

Page 563

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) promote greater independence, including enhanced independence in performing activities of daily living and instrumental activities of daily living, for persons with Alzheimer’s disease and related disorders; and
(B) prevent or reduce the severity of secondary disabilities, including confusional
episodes, falls, bladder and bowel incontinence, and adverse effects of prescription
and over-the-counter medications, in such
persons; and
(2) model curricula for health care professionals, health care paraprofessionals, and
family caregivers, for training and application
in the use of such techniques.
(e) ‘‘Council on Alzheimer’s Disease’’ defined
For purposes of this section, the term ‘‘Council on Alzheimer’s Disease’’ means the council
established in section 11211(a) 2 of this title.
(July 1, 1944, ch. 373, title IV, § 445C, formerly
Pub. L. 99–660, title IX, § 941, Nov. 14, 1986, 100
Stat. 3808; renumbered § 445C of act July 1, 1944;
amended Pub. L. 100–607, title I, § 142(a), (d)(2),
Nov. 4, 1988, 102 Stat. 3057, 3058; Pub. L. 102–507,
§ 9, Oct. 24, 1992, 106 Stat. 3287; Pub. L. 103–43,
title VIII, § 804, June 10, 1993, 107 Stat. 164.)
REFERENCES IN TEXT
Section 11211 of this title, referred to in subsec. (e),
was repealed by Pub. L. 105–362, title VI, § 601(a)(2)(E),
Nov. 10, 1998, 112 Stat. 3286.
CODIFICATION
Section was formerly classified to section 11241 of
this title prior to renumbering by Pub. L. 100–607.
AMENDMENTS
1993—Subsec. (b)(1). Pub. L. 103–43, § 804(1), inserted
‘‘on Alzheimer’s Disease (in this section referred to as
the ‘Council’)’’ after ‘‘Council’’.
Subsec. (e). Pub. L. 103–43, § 804(2), added subsec. (e).
1992—Subsec. (d). Pub. L. 102–507 added subsec. (d).
1988—Pub. L. 100–607, § 142(a), renumbered section
11241 of this title as this section.
Subsec. (a). Pub. L. 100–607, § 142(d)(2)(A), substituted
‘‘the Institute’’ for ‘‘the National Institute on Aging’’.
Subsec. (b)(1). Pub. L. 100–607, § 142(d)(2)(B)(i)(I), in introductory provisions, substituted ‘‘the date of enactment of the Alzheimer’s Disease and Related Dementias Services Research Act of 1986’’ for ‘‘the date of enactment of this Act’’, which for purposes of codification
was translated as ‘‘November 14, 1986’’, thus requiring
no change in text.
Pub. L. 100–607, § 142(d)(2)(B)(i)(II), in introductory
provisions, substituted ‘‘the Institute’’ for ‘‘the National Institute on Aging’’.
Subsec. (b)(1)(B). Pub. L. 100–607, § 142(d)(2)(B)(ii),
made technical amendment to reference to section
285e–2 of this title to correct reference to corresponding
provision of original act.
Subsecs. (b)(2), (c). Pub. L. 100–607, § 142(d)(2)(B)(iii),
(C), substituted ‘‘the Institute’’ for ‘‘the National Institute on Aging’’.

§ 285e–6. Dissemination of research results
The Director of the Institute shall disseminate
the results of research conducted under section
285e–5 of this title and this section to appropriate professional entities and to the public.
(July 1, 1944, ch. 373, title IV, § 445D, formerly
Pub. L. 99–660, title IX, § 942, Nov. 14, 1986, 100
2 See

References in Text note below.

§ 285e–7

Stat. 3809; renumbered § 445D of act July 1, 1944;
amended Pub. L. 100–607, title I, § 142(a), (d)(3),
Nov. 4, 1988, 102 Stat. 3057, 3058.)
CODIFICATION
Section was formerly classified to section 11242 of
this title prior to renumbering by Pub. L. 100–607.
AMENDMENTS
1988—Pub. L. 100–607, § 142(a), renumbered section
11242 of this title as this section.
Pub. L. 100–607, § 142(d)(3), substituted ‘‘the Institute’’
for ‘‘the National Institute on Aging’’ and ‘‘section
285e–5 of this title and this section’’ for ‘‘this part’’.

§ 285e–7. Clearinghouse on Alzheimer’s Disease
(a) Establishment; purpose; duties; publication of
summary
The Director of the Institute shall establish
the Clearinghouse on Alzheimer’s Disease (hereinafter referred to as the ‘‘Clearinghouse’’). The
purpose of the Clearinghouse is the dissemination of information concerning services available for individuals with Alzheimer’s disease and
related dementias and their families. The Clearinghouse shall—
(1) compile, archive, and disseminate information concerning research, demonstration,
evaluation, and training programs and
projects concerning Alzheimer’s disease and
related dementias; and
(2) annually publish a summary of the information compiled under paragraph (1) during
the preceding 12-month period, and make such
information available upon request to appropriate individuals and entities, including educational institutions, research entities, and
Federal and public agencies.
(b) Fee for information
The Clearinghouse may charge an appropriate
fee for information provided through the tollfree telephone line established under subsection
(a)(3).1
(c) Summaries of research findings from other
agencies
The Director of the Institute, the Director of
the National Institute of Mental Health, and the
Director of the National Center for Health Services Research and Health Care Technology Assessment shall provide to the Clearinghouse
summaries of the findings of research conducted
under part D.
(July 1, 1944, ch. 373, title IV, § 445E, formerly
Pub. L. 99–660, title IX, § 951, Nov. 14, 1986, 100
Stat. 3813; renumbered § 445E of act July 1, 1944,
and amended Pub. L. 100–607, title I, § 142(a),
(d)(4), Nov. 4, 1988, 102 Stat. 3057, 3058.)
REFERENCES IN TEXT
Part D, referred to in subsec. (c), probably means part
D of title IX of Pub. L. 99–660, Nov. 14, 1986, 100 Stat.
3808, as amended, which is classified to subchapter IV
(§ 11251 et seq.) of chapter 118 of this title. Prior to renumbering by Pub. L. 100–607, this section was part of
title IX of Pub. L. 99–660.
CODIFICATION
Section was formerly classified to section 11281 of
this title prior to renumbering by Pub. L. 100–607.
1 So

in original. No subsec. (a)(3) has been enacted.

§ 285e–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1988—Pub. L. 100–607, § 142(a), renumbered section
11281 of this title as this section.
Subsec. (a). Pub. L. 100–607, § 142(d)(4)(A), substituted
‘‘the Institute’’ for ‘‘the National Institute on Aging’’
in introductory provisions.
Subsec. (c). Pub. L. 100–607, § 142(d)(4)(B), substituted
‘‘the Institute’’ for ‘‘the National Institute on Aging’’
and ‘‘part D’’ for ‘‘part E’’.

§ 285e–8. Dissemination project
(a) Grant or contract for establishment
The Director of the Institute shall make a
grant to, or enter into a contract with, a national organization representing individuals
with Alzheimer’s disease and related dementias
for the conduct of the activities described in
subsection (b) of this section.
(b) Project activities
The organization receiving a grant or contract
under this section shall—
(1) establish a central computerized information system to—
(A) compile and disseminate information
concerning initiatives by State and local
governments and private entities to provide
programs and services for individuals with
Alzheimer’s disease and related dementias;
and
(B) translate scientific and technical information concerning such initiatives into information readily understandable by the
general public, and make such information
available upon request; and
(2) establish a national toll-free telephone
line to make available the information described in paragraph (1), and information concerning Federal programs, services, and benefits for individuals with Alzheimer’s disease
and related dementias and their families.
(c) Fees for information; exception
The organization receiving a grant or contract
under this section may charge appropriate fees
for information provided through the toll-free
telephone line established under subsection
(b)(2) of this section, and may make exceptions
to such fees for individuals and organizations
who are not financially able to pay such fees.
(d) Application for grant or contract; contents
In order to receive a grant or contract under
this section, an organization shall submit an application to the Director of the Institute. Such
application shall contain—
(1) information demonstrating that such organization has a network of contacts which
will enable such organization to receive information necessary to the operation of the central computerized information system described in subsection (b)(1) of this section;
(2) information demonstrating that, by the
end of fiscal year 1991, such organization will
be financially able to, and will, carry out the
activities described in subsection (b) of this
section without a grant or contract from the
Federal Government; and
(3) such other information as the Director
may prescribe.
(July 1, 1944, ch. 373, title IV, § 445F, formerly
Pub. L. 99–660, title IX, § 952, Nov. 14, 1986, 100

Page 564

Stat. 3813; renumbered § 445F of act July 1, 1944,
and amended Pub. L. 100–607, title I, § 142(a),
(d)(5), Nov. 4, 1988, 102 Stat. 3057, 3058.)
CODIFICATION
Section was formerly classified to section 11282 of
this title prior to renumbering by Pub. L. 100–607.
AMENDMENTS
1988—Pub. L. 100–607, § 142(a), renumbered section
11282 of this title as this section.
Subsecs. (a), (d). Pub. L. 100–607, § 142(d)(5), substituted ‘‘the Institute’’ for ‘‘the National Institute on
Aging’’.

§ 285e–9. Alzheimer’s disease registry
(a) In general
The Director of the Institute may make a
grant to develop a registry for the collection of
epidemiological data about Alzheimer’s disease
and its incidence in the United States, to train
personnel in the collection of such data, and for
other matters respecting such disease.
(b) Qualifications
To qualify for a grant under subsection (a) of
this section an applicant shall—
(1) be an accredited school of medicine or
public health which has expertise in the collection of epidemiological data about individuals with Alzheimer’s disease and in the development of disease registries, and
(2) have access to a large patient population,
including a patient population representative
of diverse ethnic backgrounds.
(July 1, 1944, ch. 373, title IV, § 445G, formerly
Pub. L. 99–158, § 12, Nov. 20, 1985, 99 Stat. 885, as
renumbered § 445G and amended Pub. L. 103–43,
title VIII, § 801, June 10, 1993, 107 Stat. 163.)
CODIFICATION
Section was formerly set out as a note under section
285e–2 of this title prior to renumbering by Pub. L.
103–43.
AMENDMENTS
1993—Pub. L. 103–43, § 801(b)(1), reenacted section
catchline without change.
Subsec. (a). Pub. L. 103–43, § 801(b)(1), substituted in
heading ‘‘In general’’ for ‘‘Grant authority’’ and in text
substituted ‘‘Director of the Institute’’ for ‘‘Director of
the National Institute on Aging’’.
Subsec. (c). Pub. L. 103–43, § 801(b)(2), struck out subsec. (c) which authorized appropriations of $2,500,000 for
grants to remain available until expended or through
fiscal year 1989, whichever occurred first.

§ 285e–10. Aging processes regarding women
The Director of the Institute, in addition to
other special functions specified in section
285e–1 of this title and in cooperation with the
Directors of the other national research institutes and agencies of the National Institutes of
Health, shall conduct research into the aging
processes of women, with particular emphasis
given to the effects of menopause and the physiological and behavioral changes occurring during the transition from pre- to post-menopause,
and into the diagnosis, disorders, and complications related to aging and loss of ovarian hormones in women.
(July 1, 1944, ch. 373, title IV, § 445H, as added
Pub. L. 103–43, title VIII, § 802, June 10, 1993, 107

Page 565

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 163; amended Pub. L. 105–340, title I, § 105,
Oct. 31, 1998, 112 Stat. 3193; Pub. L. 109–482, title
I, § 103(b)(24), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Pub. L. 109–482 struck out subsec. (a) designation before ‘‘The Director’’ and subsec. (b) which read
as follows: ‘‘For the purpose of carrying out this section, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1999
through 2003. The authorization of appropriations established in the preceding sentence is in addition to
any other authorization of appropriation that is available for such purpose.’’
1998—Pub. L. 105–340 designated existing provisions as
subsec. (a) and added subsec. (b).
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285e–10a. Alzheimer’s clinical research and
training awards
(a) In general
The Director of the Institute is authorized to
establish and maintain a program to enhance
and promote the translation of new scientific
knowledge into clinical practice related to the
diagnosis, care and treatment of individuals
with Alzheimer’s disease.
(b) Support of promising clinicians
In order to foster the application of the most
current developments in the etiology, pathogenesis, diagnosis, prevention and treatment of
Alzheimer’s disease, amounts made available
under this section shall be directed to the support of promising clinicians through awards for
research, study, and practice at centers of excellence in Alzheimer’s disease research and treatment.
(c) Excellence in certain fields
Research shall be carried out under awards
made under subsection (b) of this section in environments of demonstrated excellence in neuroscience, neurobiology, geriatric medicine, and
psychiatry and shall foster innovation and integration of such disciplines or other environments determined suitable by the Director of
the Institute.
(July 1, 1944, ch. 373, title IV, § 445I, as added
Pub. L. 106–505, title VIII, § 801(2), Nov. 13, 2000,
114 Stat. 2349; amended Pub. L. 109–482, title I,
§ 103(b)(25), Jan. 15, 2007, 120 Stat. 3688.)

§ 285f–1

subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285e–11. Repealed. Pub. L. 109–482, title I,
§ 103(b)(26), Jan. 15, 2007, 120 Stat. 3688
Section, act July 1, 1944, ch. 373, title IV, § 445J, formerly § 445I, as added Pub. L. 103–43, title VIII, § 803,
June 10, 1993, 107 Stat. 163; renumbered § 445J, Pub. L.
106–505, title VIII, § 801(1), Nov. 13, 2000, 114 Stat. 2349,
authorized appropriations to carry out this subpart.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.
SUBPART 6—NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES

§ 285f. Purpose of Institute
The general purpose of the National Institute
of Allergy and Infectious Diseases is the conduct
and support of research, training, health information dissemination, and other programs with
respect to allergic and immunologic diseases
and disorders and infectious diseases, including
tropical diseases.
(July 1, 1944, ch. 373, title IV, § 446, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 855; amended
Pub. L. 103–43, title IX, § 901, June 10, 1993, 107
Stat. 164.)
AMENDMENTS
1993—Pub. L. 103–43 inserted before period at end
‘‘, including tropical diseases’’.

§ 285f–1. Research centers regarding chronic fatigue syndrome
(a) The Director of the Institute, after consultation with the advisory council for the Institute, may make grants to, or enter into contracts with, public or nonprofit private entities
for the development and operation of centers to
conduct basic and clinical research on chronic
fatigue syndrome.
(b) Each center assisted under this section
shall use the facilities of a single institution, or
be formed from a consortium of cooperating institutions, meeting such requirements as may
be prescribed by the Director of the Institute.
(July 1, 1944, ch. 373, title IV, § 447, as added Pub.
L. 103–43, title IX, § 902(a), June 10, 1993, 107 Stat.
164.)

PRIOR PROVISIONS

CODIFICATION

A prior section 445I of act July 1, 1944, was renumbered section 445J and was classified to section 285e–11
of this title prior to repeal by Pub. L. 109–482.

Another section 447 of act July 1, 1944, was renumbered section 447A and is classified to section 285f–2 of
this title.

AMENDMENTS

EXTRAMURAL STUDY SECTION

2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated $2,250,000 for fiscal year 2001,
and such sums as may be necessary for each of fiscal
years 2002 through 2005.’’

Section 902(b) of Pub. L. 103–43 provided that: ‘‘Not
later than 6 months after the date of enactment of this
Act [June 10, 1993], the Secretary of Health and Human
Services shall establish an extramural study section for
chronic fatigue syndrome research.’’

EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or

RESEARCH ACTIVITIES ON CHRONIC FATIGUE SYNDROME
Section 1903 of Pub. L. 103–43 directed Secretary of
Health and Human Services to, not later than Oct. 1,
1993, and annually thereafter for next 3 years, prepare

§ 285f–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and submit to Congress a report that summarizes research activities conducted or supported by National
Institutes of Health concerning chronic fatigue syndrome, with information concerning grants made, cooperative agreements or contracts entered into, intramural activities, research priorities and needs, and
plan to address such priorities and needs.

§ 285f–2. Research and research training regarding tuberculosis
In carrying out section 285f of this title, the
Director of the Institute shall conduct or support research and research training regarding
the cause, diagnosis, early detection, prevention
and treatment of tuberculosis.
(July 1, 1944, ch. 373, title IV, § 447A, formerly
§ 447, as added Pub. L. 103–183, title III, § 302(a),
Dec. 14, 1993, 107 Stat. 2235; renumbered § 447A,
Pub. L. 105–392, title IV, § 401(b)(3), Nov. 13, 1998,
112 Stat. 3587; amended Pub. L. 109–482, title I,
§ 103(b)(27), Jan. 15, 2007, 120 Stat. 3688.)

Page 566

(c) Excellence in certain fields
Research shall be carried out under awards
made under subsection (b) of this section in environments of demonstrated excellence in the
etiology and pathogenesis of sexually transmitted diseases and shall foster innovation and integration of such disciplines or other environments determined suitable by the Director of
the Institute.
(July 1, 1944, ch. 373, title IV, § 447B, as added
Pub. L. 106–505, title IX, § 901, Nov. 13, 2000, 114
Stat. 2349; amended Pub. L. 109–482, title I,
§ 103(b)(28), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out heading
and text of subsec. (d). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated $2,250,000 for fiscal year 2001,
and such sums as may be necessary for each of fiscal
years 2002 through 2005.’’

AMENDMENTS

EFFECTIVE DATE OF 2007 AMENDMENT

2007—Pub. L. 109–482 struck out subsec. (a) designation before ‘‘In carrying out’’ and subsec. (b) which
read as follows: ‘‘For the purpose of carrying out subsection (a) of this section, there are authorized to be
appropriated $50,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years
1995 through 1998. Such authorization is in addition to
any other authorization of appropriations that is available for such purpose.’’

Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
RESEARCH THROUGH FOOD AND DRUG ADMINISTRATION
Section 303 of Pub. L. 103–183 provided that: ‘‘The
Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall implement a tuberculosis drug and device research program under which the Commissioner may—
‘‘(1) provide assistance to other Federal agencies for
the development of tuberculosis protocols;
‘‘(2) review and evaluate medical devices designed
for the diagnosis and control of airborne tuberculosis;
and
‘‘(3) conduct research concerning drugs or devices
to be used in diagnosing, controlling and preventing
tuberculosis.’’

§ 285f–3. Sexually transmitted disease clinical research and training awards
(a) In general
The Director of the Institute is authorized to
establish and maintain a program to enhance
and promote the translation of new scientific
knowledge into clinical practice related to the
diagnosis, care and treatment of individuals
with sexually transmitted diseases.
(b) Support of promising clinicians
In order to foster the application of the most
current developments in the etiology, pathogenesis, diagnosis, prevention and treatment of
sexually transmitted diseases, amounts made
available under this section shall be directed to
the support of promising clinicians through
awards for research, study, and practice at centers of excellence in sexually transmitted disease research and treatment.

§ 285f–4. Microbicide research and development
The Director of the Institute, acting through
the head of the Division of AIDS, shall, consistent with the peer-review process of the National
Institutes of Health, carry out research on, and
development of, safe and effective methods for
use by women to prevent the transmission of the
human immunodeficiency virus, which may include microbicides.
(July 1, 1944, ch. 373, title IV, § 447C, as added
Pub. L. 110–293, title II, § 203(c), July 30, 2008, 122
Stat. 2941.)
SUBPART 7—EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

AMENDMENTS
2007—Pub. L. 110–154, § 1(b)(7), Dec. 21, 2007, 121 Stat.
1827, substituted ‘‘Eunice Kennedy Shriver National Institute of Child Health and Human Development’’ for
‘‘National Institute of Child Health and Human Development’’ in subpart heading.

§ 285g. Purpose of Institute
The general purpose of the Eunice Kennedy
Shriver National Institute of Child Health and
Human Development (hereafter in this subpart
referred to as the ‘‘Institute’’) is the conduct
and support of research, training, health information dissemination, and other programs with
respect to gynecologic health, maternal health,
child health, intellectual disabilities, human
growth and development, including prenatal development, population research, and special
health problems and requirements of mothers
and children.
(July 1, 1944, ch. 373, title IV, § 448, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended
Pub. L. 106–554, § 1(a)(1) [title II, § 215], Dec. 21,
2000, 114 Stat. 2763, 2763A–28; Pub. L. 110–154,
§ 1(d), Dec. 21, 2007, 121 Stat. 1828; Pub. L. 111–256,
§ 2(f)(2), Oct. 5, 2010, 124 Stat. 2644.)

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2010—Pub. L. 111–256 substituted ‘‘intellectual disabilities,’’ for ‘‘mental retardation,’’.
2000—Pub. L. 106–554 inserted ‘‘gynecologic health,’’
after ‘‘with respect to’’.
CHANGE OF NAME
‘‘Eunice Kennedy Shriver National Institute of Child
Health and Human Development’’ substituted for ‘‘National Institute of Child Health and Human Development’’ in text, on authority of section 1(d) of Pub. L.
110–154, set out below.
Pub. L. 110–154, § 1(d), Dec. 21, 2007, 121 Stat. 1828, provided that: ‘‘Any reference in any law, regulation,
order, document, paper, or other record of the United
States to the ‘National Institute of Child Health and
Human Development’ shall be deemed to be a reference
to the ‘Eunice Kennedy Shriver National Institute of
Child Health and Human Development’.’’
EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF
CHILD HEALTH AND HUMAN DEVELOPMENT; FINDINGS
Pub. L. 110–154, § 1(a), Dec. 21, 2007, 121 Stat. 1826, as
amended by Pub. L. 111–256, § 2(h), Oct. 5, 2010, 124 Stat.
2644, provided that: ‘‘Congress makes the following
findings:
‘‘(1) Since it was established by Congress in 1962 at
the request of President John F. Kennedy, the National Institute of Child Health and Human Development has achieved an outstanding record of achievement in catalyzing a concentrated attack on the unsolved health problems of children and of mother-infant relationships by fulfilling its mission to—
‘‘(A) ensure that every individual is born healthy
and wanted, that women suffer no harmful effects
from reproductive processes, and that all children
have the chance to achieve their full potential for
healthy and productive lives, free from disease or
disability; and
‘‘(B) ensure the health, productivity, independence, and well-being of all individuals through optimal rehabilitation.
‘‘(2) The National Institute of Child Health and
Human Development has made unparalleled contributions to the advancement of child health and human
development, including significant efforts to—
‘‘(A) reduce dramatically the rates of Sudden Infant Death Syndrome, infant mortality, and maternal HIV transmission;
‘‘(B) develop the Haemophilus Influenza B (Hib)
vaccine, credited with nearly eliminating the incidence of intellectual disabilities; and
‘‘(C) conduct intramural research, support extramural research, and train thousands of child health
and human development researchers who have contributed greatly to dramatic gains in child health
throughout the world.
‘‘(3) The vision, drive, and tenacity of one woman,
Eunice Kennedy Shriver, was instrumental in proposing, passing, and enacting legislation to establish the
National Institute of Child Health and Human Development (Public Law 87–838) [see Tables for classification] on October 17, 1962.
‘‘(4) It is befitting and appropriate to recognize the
substantial achievements of Eunice Kennedy Shriver,
a tireless advocate for children with special needs,
whose foresight in creating the National Institute of
Child Health and Human Development gave life to
the words of President Kennedy, who wished to ‘encourage imaginative research into the complex processes of human development from conception to old
age.’ ’’
[For definition of ‘‘intellectual disabilities’’ in section 1(a) of Pub. L. 110–154, set out above, see Definitions note below.]

§ 285g

Dec. 3, 2004, 118 Stat. 2803; Pub. L. 109–482, title I,
§ 104(b)(3)(E), Jan. 15, 2007, 120 Stat. 3694; Pub. L. 110–154,
§ 1(d), Dec. 21, 2007, 121 Stat. 1828, provided that:
‘‘(a) PURPOSE.—It is the purpose of this section to authorize the Eunice Kennedy Shriver National Institute
of Child Health and Human Development to conduct a
national longitudinal study of environmental influences (including physical, chemical, biological, and
psychosocial) on children’s health and development.
‘‘(b) IN GENERAL.—The Director of the Eunice Kennedy Shriver National Institute of Child Health and
Human Development shall establish a consortium of
representatives from appropriate Federal agencies (including the Centers for Disease Control and Prevention,
the Environmental Protection Agency, and the Department of Education) to—
‘‘(1) plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the
effects of both chronic and intermittent exposures on
child health and human development; and
‘‘(2) investigate basic mechanisms of developmental
disorders and environmental factors, both risk and
protective, that influence health and developmental
processes.
‘‘(c) REQUIREMENT.—The study under subsection (b)
shall—
‘‘(1) incorporate behavioral, emotional, educational, and contextual consequences to enable a
complete assessment of the physical, chemical, biological and psychosocial environmental influences on
children’s well-being;
‘‘(2) gather data on environmental influences and
outcomes on diverse populations of children, which
may include the consideration of prenatal exposures;
‘‘(3) consider health disparities among children
which may include the consideration of prenatal exposures; and
‘‘(4) be conducted in compliance with section 444 of
the General Education Provisions Act (20 U.S.C.
1232g), including the requirement of prior parental
consent for the disclosure of any education records,
except without the use of authority or exceptions
granted to authorized representatives of the Secretary of Education for the evaluation of Federallysupported education programs or in connection with
the enforcement of the Federal legal requirements
that relate to such programs.
‘‘[(d) REPEALED. Pub. L. 109–482, title I, § 104(b)(3)(E),
Jan. 15, 2007, 120 Stat. 3694.]
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
$18,000,000 for fiscal year 2001, and such sums as may be
necessary for each [sic] the fiscal years 2002 through
2005.’’
NATIONAL COMMISSION TO PREVENT INFANT MORTALITY;
COMPOSITION; VOLUNTARY SERVICES; DURATION
Pub. L. 100–436, title IV, Sept. 20, 1988, 102 Stat. 1709,
provided that the National Commission to Prevent Infant Mortality was to be composed of sixteen members,
including seven at large members, and that it had
power to accept voluntary and uncompensated services,
notwithstanding section 1342 of title 31, and was to continue operating, notwithstanding sections 208 and 209 of
Pub. L. 99–660 (formerly set out below).
NATIONAL COMMISSION TO PREVENT INFANT MORTALITY
Pub. L. 99–660, title II, Nov. 14, 1986, 100 Stat. 3752,
known as the National Commission to Prevent Infant
Mortality Act of 1986, established National Commission
to Prevent Infant Mortality to examine and make recommendation on government and private resources,
policies, and programs which impact on infant mortality, required Commission to submit recommendations
to President and Congress no later than one year after
Nov. 14, 1986, and terminated Commission 90 days after
submission of recommendations.

LONG-TERM CHILD DEVELOPMENT STUDY

DEFINITIONS

Pub. L. 106–310, div. A, title X, § 1004, Oct. 17, 2000, 114
Stat. 1130, as amended by Pub. L. 108–446, title III, § 301,

For meaning of references to an intellectual disability and to individuals with intellectual disabilities in

§ 285g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 285g–1. Sudden infant death syndrome research
The Director of the Institute shall conduct
and support research which specifically relates
to sudden infant death syndrome.
(July 1, 1944, ch. 373, title IV, § 449, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856.)
§ 285g–2. Research on intellectual disabilities
The Director of the Institute shall conduct
and support research and related activities into
the causes, prevention, and treatment of intellectual disabilities.
(July 1, 1944, ch. 373, title IV, § 450, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended
Pub. L. 111–256, § 2(f)(3), Oct. 5, 2010, 124 Stat.
2644.)
AMENDMENTS
2010—Pub. L. 111–256 amended section generally. Prior
to amendment, text read as follows: ‘‘The Director of
the Institute shall conduct and support research and
related activities into the causes, prevention, and
treatment of mental retardation.’’
DEFINITIONS
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 285g–3. Associate Director for Prevention; appointment; function
There shall be in the Institute an Associate
Director for Prevention to coordinate and promote the programs in the Institute concerning
the prevention of health problems of mothers
and children. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional
training or experience are experts in public
health or preventive medicine.
(July 1, 1944, ch. 373, title IV, § 451, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended
Pub. L. 105–362, title VI, § 601(a)(1)(E), Nov. 10,
1998, 112 Stat. 3285.)
AMENDMENTS
1998—Pub. L. 105–362 struck out subsec. (a) designation and struck out subsec. (b) which read as follows:
‘‘The Associate Director for Prevention shall prepare
for inclusion in the biennial report made under section
284b of this title a description of the prevention activities of the Institute, including a description of the staff
and resources allocated to those activities.’’

§ 285g–4. National Center for Medical Rehabilitation Research
(a) Establishment of Center
There shall be in the Institute an agency to be
known as the National Center for Medical Rehabilitation Research (hereafter in this section referred to as the ‘‘Center’’). The Director of the
Institute shall appoint a qualified individual to
serve as Director of the Center. The Director of
the Center shall report directly to the Director
of the Institute.

Page 568

(b) Purpose
The general purpose of the Center is the conduct and support of research and research training (including research on the development of
orthotic and prosthetic devices), the dissemination of health information, and other programs
with respect to the rehabilitation of individuals
with physical disabilities resulting from diseases or disorders of the neurological, musculoskeletal, cardiovascular, pulmonary, or any
other physiological system (hereafter in this
section referred to as ‘‘medical rehabilitation’’).
(c) Authority of Director
(1) In carrying out the purpose described in
subsection (b) of this section, the Director of the
Center may—
(A) provide for clinical trials regarding medical rehabilitation;
(B) provide for research regarding model systems of medical rehabilitation;
(C) coordinate the activities of the Center
with similar activities of other agencies of the
Federal Government, including the other
agencies of the National Institutes of Health,
and with similar activities of other public entities and of private entities;
(D) support multidisciplinary medical rehabilitation research conducted or supported by
more than one such agency;
(E) in consultation with the advisory council
for the Institute and with the approval of the
Director of NIH—
(i) establish technical and scientific peer
review groups in addition to those appointed
under section 282(b)(16) of this title; and
(ii) appoint the members of peer review
groups established under subparagraph (A);
and
(F) support medical rehabilitation research
and training centers.
The Federal Advisory Committee Act shall not
apply to the duration of a peer review group appointed under subparagraph (E).
(2) In carrying out this section, the Director of
the Center may make grants and enter into cooperative agreements and contracts.
(d) Research Plan
(1) In consultation with the Director of the
Center, the coordinating committee established
under subsection (e) of this section, and the advisory board established under subsection (f) of
this section, the Director of the Institute shall
develop a comprehensive plan for the conduct
and support of medical rehabilitation research
(hereafter in this section referred to as the ‘‘Research Plan’’).
(2) The Research Plan shall—
(A) identify current medical rehabilitation
research activities conducted or supported by
the Federal Government, opportunities and
needs for additional research, and priorities
for such research; and
(B) make recommendations for the coordination of such research conducted or supported
by the National Institutes of Health and other
agencies of the Federal Government.
(3)(A) Not later than 18 months after the date
of the enactment of the National Institutes of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Health Revitalization Amendments of 1990, the
Director of the Institute shall transmit the Research Plan to the Director of NIH, who shall
submit the Plan to the President and the Congress.
(B) Subparagraph (A) shall be carried out independently of the process of reporting that is required in sections 283 and 284b 1 of this title.
(4) The Director of the Institute shall periodically revise and update the Research Plan as appropriate, after consultation with the Director
of the Center, the coordinating committee established under subsection (e) of this section,
and the advisory board established under subsection (f) of this section. A description of any
revisions in the Research Plan shall be contained in each report prepared under section
284b 1 of this title by the Director of the Institute.
(e) Medical Rehabilitation Coordinating Committee
(1) The Director of NIH shall establish a committee to be known as the Medical Rehabilitation Coordinating Committee (hereafter in this
section referred to as the ‘‘Coordinating Committee’’).
(2) The Coordinating Committee shall make
recommendations to the Director of the Institute and the Director of the Center with respect
to the content of the Research Plan and with respect to the activities of the Center that are
carried out in conjunction with other agencies
of the National Institutes of Health and with
other agencies of the Federal Government.
(3) The Coordinating Committee shall be composed of the Director of the Center, the Director
of the Institute, and the Directors of the National Institute on Aging, the National Institute
of Arthritis and Musculoskeletal and Skin Diseases, the National Heart, Lung, and Blood Institute, the National Institute of Neurological
Disorders and Stroke, and such other national
research institutes and such representatives of
other agencies of the Federal Government as the
Director of NIH determines to be appropriate.
(4) The Coordinating Committee shall be
chaired by the Director of the Center.
(f) National Advisory Board on Medical Rehabilitation Research
(1) Not later than 90 days after the date of the
enactment of the National Institutes of Health
Revitalization Amendments of 1990, the Director
of NIH shall establish a National Advisory Board
on Medical Rehabilitation Research (hereafter
in this section referred to as the ‘‘Advisory
Board’’).
(2) The Advisory Board shall review and assess
Federal research priorities, activities, and findings regarding medical rehabilitation research,
and shall advise the Director of the Center and
the Director of the Institute on the provisions of
the Research Plan.
(3)(A) The Director of NIH shall appoint to the
Advisory Board 18 qualified representatives of
the public who are not officers or employees of
the Federal Government. Of such members, 12
shall be representatives of health and scientific
disciplines with respect to medical rehabilita1 See

References in Text note below.

§ 285g–4

tion and 6 shall be individuals representing the
interests of individuals undergoing, or in need
of, medical rehabilitation.
(B) The following officials shall serve as ex
officio members of the Advisory Board:
(i) The Director of the Center.
(ii) The Director of the Institute.
(iii) The Director of the National Institute
on Aging.
(iv) The Director of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases.
(v) The Director of the National Institute on
Deafness and Other Communication Disorders.
(vi) The Director of the National Heart,
Lung, and Blood Institute.
(vii) The Director of the National Institute
of Neurological Disorders and Stroke.
(viii) The Director of the National Institute
on Disability and Rehabilitation Research.
(ix) The Commissioner for Rehabilitation
Services Administration.
(x) The Assistant Secretary of Defense
(Health Affairs).
(xi) The Under Secretary for Health of the
Department of Veterans Affairs.
(4) The members of the Advisory Board shall,
from among the members appointed under paragraph (3)(A), designate an individual to serve as
the chair of the Advisory Board.
(July 1, 1944, ch. 373, title IV, § 452, as added Pub.
L. 101–613, § 3(a), Nov. 16, 1990, 104 Stat. 3227;
amended Pub. L. 102–405, title III, § 302(e)(1), Oct.
9, 1992, 106 Stat. 1985; Pub. L. 109–482, title I,
§ 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (c)(1), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
as amended, which is set out in the Appendix to Title
5, Government Organization and Employees.
The date of the enactment of the National Institutes
of Health Revitalization Amendments of 1990, referred
to in subsecs. (d)(3)(A) and (f)(1), probably means the
date of enactment of the National Institutes of Health
Amendments of 1990, Pub. L. 101–613, which was approved Nov. 16, 1990.
Section 284b of this title, referred to in subsec.
(d)(3)(B), (4), was repealed by Pub. L. 109–482, title I,
§ 104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.
AMENDMENTS
2007—Subsec. (c)(1)(E)(i). Pub. L. 109–482 substituted
‘‘section 282(b)(16)’’ for ‘‘section 282(b)(6)’’.
1992—Subsec. (f)(3)(B)(xi). Pub. L. 102–405 substituted
‘‘Under Secretary for Health of the Department of Veterans Affairs’’ for ‘‘Chief Medical Director of the Department of Veterans Affairs’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
PREVENTING DUPLICATIVE PROGRAMS OF MEDICAL
REHABILITATION RESEARCH
Section 3(b) of Pub. L. 101–613 provided that:
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services and the heads of other Federal agencies shall—
‘‘(A) jointly review the programs being carried out
(or proposed to be carried out) by each such official
with respect to medical rehabilitation research; and

§ 285g–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(B) as appropriate, enter into agreements for preventing duplication among such programs.
‘‘(2) TIME FOR COMPLETION.—The agreements required
in paragraph (1)(B) shall be made not later than one
year after the date of the enactment of this Act [Nov.
16, 1990].
‘‘(3) DEFINITION OF MEDICAL REHABILITATION.—For purposes of this subsection, the term ‘medical rehabilitation’ means the rehabilitation of individuals with physical disabilities resulting from diseases or disorders of
the neurological, musculoskeletal, cardiovascular, pulmonary, or any other physiological system.’’
TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by Congress, its duration is otherwise provided
by law. See sections 3(2) and 14 of Pub. L. 92–463, Oct.
6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title
5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 285g–5. Research centers with respect to contraception and infertility
(a) Grants and contracts
The Director of the Institute, after consultation with the advisory council for the Institute,
shall make grants to, or enter into contracts
with, public or nonprofit private entities for the
development and operation of centers to conduct
activities for the purpose of improving methods
of contraception and centers to conduct activities for the purpose of improving methods of diagnosis and treatment of infertility.
(b) Number of centers
In carrying out subsection (a) of this section,
the Director of the Institute shall, subject to the
extent of amounts made available in appropriations Acts, provide for the establishment of
three centers with respect to contraception and
for two centers with respect to infertility.
(c) Duties
(1) Each center assisted under this section
shall, in carrying out the purpose of the center
involved—
(A) conduct clinical and other applied research, including—
(i) for centers with respect to contraception, clinical trials of new or improved drugs
and devices for use by males and females (including barrier methods); and
(ii) for centers with respect to infertility,
clinical trials of new or improved drugs and
devices for the diagnosis and treatment of
infertility in males and females;
(B) develop protocols for training physicians, scientists, nurses, and other health and
allied health professionals;
(C) conduct training programs for such individuals;
(D) develop model continuing education programs for such professionals; and

Page 570

(E) disseminate information to such professionals and the public.
(2) A center may use funds provided under subsection (a) of this section to provide stipends for
health and allied health professionals enrolled
in programs described in subparagraph (C) of
paragraph (1), and to provide fees to individuals
serving as subjects in clinical trials conducted
under such paragraph.
(d) Coordination of information
The Director of the Institute shall, as appropriate, provide for the coordination of information among the centers assisted under this section.
(e) Facilities
Each center assisted under subsection (a) of
this section shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of
the Institute.
(f) Period of support
Support of a center under subsection (a) of
this section may be for a period not exceeding 5
years. Such period may be extended for one or
more additional periods not exceeding 5 years if
the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to
the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, § 452A, as added
Pub. L. 103–43, title X, § 1001, June 10, 1993, 107
Stat. 165; amended Pub. L. 109–482, title I,
§ 103(b)(29), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (g). Pub. L. 109–482 struck out subsec.
(g) which read as follows: ‘‘For the purpose of carrying
out this section, there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 and
1996.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285g–6. Program regarding obstetrics and gynecology
The Director of the Institute shall establish
and maintain within the Institute an intramural
laboratory and clinical research program in obstetrics and gynecology.
(July 1, 1944, ch. 373, title IV, § 452B, as added
Pub. L. 103–43, title X, § 1011, June 10, 1993, 107
Stat. 166.)
§ 285g–7. Child health research centers
The Director of the Institute shall develop and
support centers for conducting research with respect to child health. Such centers shall give
priority to the expeditious transfer of advances
from basic science to clinical applications and
improving the care of infants and children.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title IV, § 452C, as added
Pub. L. 103–43, title X, § 1021, June 10, 1993, 107
Stat. 167.)
§ 285g–8. Prospective longitudinal study on adolescent health
(a) In general
Not later than October 1, 1993, the Director of
the Institute shall commence a study for the
purpose of providing information on the general
health and well-being of adolescents in the
United States, including, with respect to such
adolescents, information on—
(1) the behaviors that promote health and
the behaviors that are detrimental to health;
and
(2) the influence on health of factors particular to the communities in which the adolescents reside.
(b) Design of study
(1) In general
The study required in subsection (a) of this
section shall be a longitudinal study in which
a substantial number of adolescents participate as subjects. With respect to the purpose
described in such subsection, the study shall
monitor the subjects throughout the period of
the study to determine the health status of
the subjects and any change in such status
over time.
(2) Population-specific analyses
The study required in subsection (a) of this
section shall be conducted with respect to the
population of adolescents who are female, the
population of adolescents who are male, various socioeconomic populations of adolescents,
and various racial and ethnic populations of
adolescents. The study shall be designed and
conducted in a manner sufficient to provide
for a valid analysis of whether there are significant differences among such populations in
health status and whether and to what extent
any such differences are due to factors particular to the populations involved.
(c) Coordination with Women’s Health Initiative
With respect to the national study of women
being conducted by the Secretary and known as
the Women’s Health Initiative, the Secretary
shall ensure that such study is coordinated with
the component of the study required in subsection (a) of this section that concerns adolescent females, including coordination in the design of the 2 studies.
(July 1, 1944, ch. 373, title IV, § 452D, as added
Pub. L. 103–43, title X, § 1031, June 10, 1993, 107
Stat. 167.)
§ 285g–9. Fragile X
(a) Expansion and coordination of research activities
The Director of the Institute, after consultation with the advisory council for the Institute,
shall expand, intensify, and coordinate the activities of the Institute with respect to research
on the disease known as fragile X.
(b) Research centers
(1) In general
The Director of the Institute shall make
grants or enter into contracts for the develop-

§ 285g–9

ment and operation of centers to conduct research for the purposes of improving the diagnosis and treatment of, and finding the cure
for, fragile X.
(2) Number of centers
(A) In general
In carrying out paragraph (1), the Director
of the Institute shall, to the extent that
amounts are appropriated, and subject to
subparagraph (B), provide for the establishment of at least three fragile X research centers.
(B) Peer review requirement
The Director of the Institute shall make a
grant to, or enter into a contract with, an
entity for purposes of establishing a center
under paragraph (1) only if the grant or contract has been recommended after technical
and scientific peer review required by regulations under section 289a of this title.
(3) Activities
The Director of the Institute, with the assistance of centers established under paragraph (1), shall conduct and support basic and
biomedical research into the detection and
treatment of fragile X.
(4) Coordination among centers
The Director of the Institute shall, as appropriate, provide for the coordination of the activities of the centers assisted under this section, including providing for the exchange of
information among the centers.
(5) Certain administrative requirements
Each center assisted under paragraph (1)
shall use the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such requirements as
may be prescribed by the Director of the Institute.
(6) Duration of support
Support may be provided to a center under
paragraph (1) for a period not exceeding 5
years. Such period may be extended for one or
more additional periods, each of which may
not exceed 5 years, if the operations of such
center have been reviewed by an appropriate
technical and scientific peer review group established by the Director and if such group has
recommended to the Director that such period
be extended.
(July 1, 1944, ch. 373, title IV, § 452E, as added
Pub. L. 106–310, div. A, title II, § 201, Oct. 17, 2000,
114 Stat. 1109; amended Pub. L. 109–482, title I,
§ 103(b)(30), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (b)(7). Pub. L. 109–482 struck out heading and text of par. (7). Text read as follows: ‘‘For the
purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285g–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 285g–10. Investment in tomorrow’s pediatric researchers
In order to ensure the future supply of researchers dedicated to the care and research
needs of children, the Director of the Institute,
after consultation with the Administrator of the
Health Resources and Services Administration,
shall support activities to provide for—
(1) an increase in the number and size of institutional training grants to institutions supporting pediatric training; and
(2) an increase in the number of career development awards for health professionals who
intend to build careers in pediatric basic and
clinical research, including pediatric pharmacological research.
(July 1, 1944, ch. 373, title IV, § 452G, as added
Pub. L. 106–310, div. A, title X, § 1002(a), Oct. 17,
2000, 114 Stat. 1128; amended Pub. L. 109–482, title
I, § 103(b)(31), Jan. 15, 2007, 120 Stat. 3688; Pub. L.
110–85, title V, § 503(a), Sept. 27, 2007, 121 Stat.
890.)
AMENDMENTS
2007—Pub. L. 109–482 struck out subsec. (a) designation and heading before ‘‘In order to’’ and struck out
heading and text of subsec. (b). Text read as follows:
‘‘For the purpose of carrying out subsection (a) of this
section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
2001 through 2005.’’
Par. (2). Pub. L. 110–85 inserted ‘‘, including pediatric
pharmacological research’’ before period at end.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 8—NATIONAL INSTITUTE OF DENTAL
RESEARCH

§ 285h. Purpose of Institute
The general purpose of the National Institute
of Dental Research is the conduct and support of
research, training, health information dissemination, and other programs with respect to the
cause, prevention, and methods of diagnosis and
treatment of dental and oral diseases and conditions.
(July 1, 1944, ch. 373, title IV, § 453, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856.)
SUBPART 9—NATIONAL EYE INSTITUTE

§ 285i. Purpose of Institute
The general purpose of the National Eye Institute (hereafter in this subpart referred to as the
‘‘Institute’’) is the conduct and support of research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of
visual function, preservation of sight, and the
special health problems and requirements of the
blind. Subject to section 285i–1 of this title, the
Director of the Institute may carry out a program of grants for public and private nonprofit
vision research facilities.
(July 1, 1944, ch. 373, title IV, § 455, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended

Page 572

Pub. L. 103–43, title XI, § 1101(b), June 10, 1993, 107
Stat. 169.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘Subject to section
285i–1 of this title, the Director’’ for ‘‘The Director’’ in
second sentence.

§ 285i–1. Clinical research on eye care and diabetes
(a) Program of grants
The Director of the Institute, in consultation
with the advisory council for the Institute, may
award research grants to one or more Diabetes
Eye Research Institutions for the support of programs in clinical or health services aimed at—
(1) providing comprehensive eye care services for people with diabetes, including a full
complement of preventive, diagnostic and
treatment procedures;
(2) developing new and improved techniques
of patient care through basic and clinical research;
(3) assisting in translation of the latest research advances into clinical practice; and
(4) expanding the knowledge of the eye and
diabetes through further research.
(b) Use of funds
Amounts received under a grant awarded
under this section shall be used for the following:
(1) Establishing the biochemical, cellular,
and genetic mechanisms associated with diabetic eye disease and the earlier detection of
pending eye abnormalities. The focus of work
under this paragraph shall require that ophthalmologists have training in the most up-todate molecular and cell biological methods.
(2) Establishing new frontiers in technology,
such as video-based diagnostic and research
resources, to—
(A) provide improved patient care;
(B) provide for the evaluation of retinal
physiology and its affect on diabetes; and
(C) provide for the assessment of risks for
the development and progression of diabetic
eye disease and a more immediate evaluation of various therapies aimed at preventing diabetic eye disease.
Such technologies shall be designed to permit
evaluations to be performed both in humans
and in animal models.
(3) The translation of the results of vision
research into the improved care of patients
with diabetic eye disease. Such translation
shall require the application of institutional
resources that encompass patient care, clinical research and basic laboratory research.
(4) The conduct of research concerning the
outcomes of eye care treatments and eye
health education programs as they relate to
patients with diabetic eye disease, including
the evaluation of regional approaches to such
research.
(c) Authorized expenditures
The purposes for which a grant under subsection (a) of this section may be expended include equipment for the research described in
such subsection.

Page 573

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title IV, § 456, as added Pub.
L. 103–43, title XI, § 1101(a), June 10, 1993, 107
Stat. 168.)
SUBPART 10—NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND STROKE

AMENDMENTS
1988—Pub. L. 100–553, § 2(2), Oct. 28, 1988, 102 Stat. 2769,
and Pub. L. 100–607, title I, § 101(2), Nov. 4, 1988, 102 Stat.
3049, made identical amendments to subpart heading,
substituting ‘‘Neurological Disorders’’ for ‘‘Neurological and Communicative Disorders’’. Pub. L. 100–690,
title II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238, amended
subpart heading to read as if the amendment by Pub. L.
100–607 had not been enacted.

§ 285j. Purpose of Institute
The general purpose of the National Institute
of Neurological Disorders and Stroke (hereafter
in this subpart referred to as the ‘‘Institute’’) is
the conduct and support of research, training,
health information dissemination, and other
programs with respect to neurological disease
and disorder and stroke.
(July 1, 1944, ch. 373, title IV, § 457, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended
Pub. L. 100–553, § 2(3), Oct. 28, 1988, 102 Stat. 2769;
Pub. L. 100–607, title I, § 101(3), Nov. 4, 1988, 102
Stat. 3049; Pub. L. 100–690, title II, § 2613(b)(2),
Nov. 18, 1988, 102 Stat. 4238; Pub. L. 101–93, § 5(a),
Aug. 16, 1989, 103 Stat. 611.)
AMENDMENTS
1989—Pub. L. 101–93 substituted ‘‘disease and’’ for
‘‘disease and and’’.
1988—Pub. L. 100–553 and Pub. L. 100–607 made identical amendments, substituting ‘‘Neurological Disorders’’ for ‘‘Neurological and Communicative Disorders’’ and ‘‘and disorder and stroke’’ for ‘‘disorder,
stroke, and disorders of human communication’’. Pub.
L. 100–690 amended this section to read as if the amendments by Pub. L. 100–607 had not been enacted.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.

§ 285j–1. Spinal cord regeneration research
The Director of the Institute shall conduct
and support research into spinal cord regeneration.
(July 1, 1944, ch. 373, title IV, § 458, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857.)
INTERAGENCY COMMITTEE ON SPINAL CORD INJURY
Section 7 of Pub. L. 99–158 provided that:
‘‘(a) ESTABLISHMENT.—Within 90 days after the date of
enactment of this Act [Nov. 20, 1985], the Secretary of
Health and Human Services shall establish in the National Institute of Neurological and Communicative
Diseases and Stroke an Interagency Committee on Spinal Cord Injury (hereafter in this section referred to as
the ‘Interagency Committee’). The Interagency Committee shall plan, develop, coordinate, and implement
comprehensive Federal initiatives in research on spinal
cord injury and regeneration.
‘‘(b) COMMITTEE COMPOSITION AND MEETINGS.—(1) The
Interagency Committee shall consist of representatives
from—
‘‘(A) the National Institute on Neurological and
Communicative Disorders and Stroke;

§ 285l

‘‘(B) the Department of Defense;
‘‘(C) the Department of Education;
‘‘(D) the Veterans’ Administration;
‘‘(E) the Office of Science and Technology Policy;
and
‘‘(F) the National Science Foundation;
designated by the heads of such entities.
‘‘(2) The Interagency Committee shall meet at least
four times. The Secretary of Health and Human Services shall select the Chairman of the Interagency Committee from the members of the Interagency Committee.
‘‘(c) REPORT.—Within the 18 months after the date of
enactment of this Act [Nov. 20, 1985], the Interagency
Committee shall prepare and transmit to the Congress
a report concerning its activities under this section.
The report shall include a description of research
projects on spinal cord injury and regeneration conducted or supported by Federal agencies during such 18month period, the nature and purpose of each such
project, the amounts expended for each such project,
and an identification of the entity which conducted the
research under each such project.
‘‘(d) TERMINATION.—The Interagency Committee shall
terminate 90 days after the date on which the Interagency Committee transmits the report required by
subsection (c) to the Congress.’’

§ 285j–2. Bioengineering research
The Director of the Institute shall make
grants or enter into contracts for research on
the means to overcome paralysis of the extremities through electrical stimulation and the use
of computers.
(July 1, 1944, ch. 373, title IV, § 459, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857.)
§ 285j–3. Research on multiple sclerosis
The Director of the Institute shall conduct
and support research on multiple sclerosis, especially research on effects of genetics and hormonal changes on the progress of the disease.
(July 1, 1944, ch. 373, title IV, § 460, as added Pub.
L. 103–43, title XII, § 1201, June 10, 1993, 107 Stat.
169.)
SUBPART 11—NATIONAL INSTITUTE OF GENERAL
MEDICAL SCIENCES

§ 285k. Purpose of Institute
The general purpose of the National Institute
of General Medical Sciences is the conduct and
support of research, training, and, as appropriate, health information dissemination, and
other programs with respect to general or basic
medical sciences and related natural or behavioral sciences which have significance for two or
more other national research institutes or are
outside the general area of responsibility of any
other national research institute.
(July 1, 1944, ch. 373, title IV, § 461, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857.)
SUBPART 12—NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES

§ 285l. Purpose of Institute
The general purpose of the National Institute
of Environmental Health Sciences (in this subpart referred to as the ‘‘Institute’’) is the conduct and support of research, training, health
information dissemination, and other programs

§ 285l–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 574

with respect to factors in the environment that
affect human health, directly or indirectly.

(Pub. L. 106–545, § 2, Dec. 19, 2000, 114 Stat. 2721.)

(July 1, 1944, ch. 373, title IV, § 463, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended
Pub. L. 103–43, title XIII, § 1301(b), June 10, 1993,
107 Stat. 170.)

Section was enacted as part of the ICCVAM Authorization Act of 2000, and not as part of the Public Health
Service Act which comprises this chapter.

AMENDMENTS
1993—Pub. L. 103–43 inserted ‘‘(in this subpart referred
to as the ‘Institute’)’’ after ‘‘Sciences’’.

§ 285l–1. Applied Toxicological Research and
Testing Program
(a) There is established within the Institute a
program for conducting applied research and
testing regarding toxicology, which program
shall be known as the Applied Toxicological Research and Testing Program.
(b) In carrying out the program established
under subsection (a) of this section, the Director
of the Institute shall, with respect to toxicology, carry out activities—
(1) to expand knowledge of the health effects
of environmental agents;
(2) to broaden the spectrum of toxicology information that is obtained on selected chemicals;
(3) to develop and validate assays and protocols, including alternative methods that can
reduce or eliminate the use of animals in
acute or chronic safety testing;
(4) to establish criteria for the validation
and regulatory acceptance of alternative testing and to recommend a process through
which scientifically validated alternative
methods can be accepted for regulatory use;
(5) to communicate the results of research to
government agencies, to medical, scientific,
and regulatory communities, and to the public; and
(6) to integrate related activities of the Department of Health and Human Services.
(July 1, 1944, ch. 373, title IV, § 463A, as added
Pub. L. 103–43, title XIII, § 1301(a), June 10, 1993,
107 Stat. 169.)
§ 285l–2. Definitions
In sections 285l–2 to 285l–5 of this title:
(1) Alternative test method
The term ‘‘alternative test method’’ means a
test method that—
(A) includes any new or revised test method; and
(B)(i) reduces the number of animals required;
(ii) refines procedures to lessen or eliminate pain or distress to animals, or enhances
animal well-being; or
(iii) replaces animals with non-animal systems or one animal species with a
phylogenetically lower animal species, such
as replacing a mammal with an invertebrate.
(2) ICCVAM test recommendation
The term ‘‘ICCVAM test recommendation’’
means a summary report prepared by the
ICCVAM characterizing the results of a scientific expert peer review of a test method.

CODIFICATION

§ 285l–3. Interagency Coordinating Committee on
the Validation of Alternative Methods
(a) In general
With respect to the interagency coordinating
committee that is known as the Interagency Coordinating Committee on the Validation of Alternative Methods (referred to in sections 285l–2
to 285l–5 of this title as ‘‘ICCVAM’’) and that
was established by the Director of the National
Institute of Environmental Health Sciences for
purposes of section 285l–1(b) of this title, the Director of the Institute shall designate such committee as a permanent interagency coordinating
committee of the Institute under the National
Toxicology Program Interagency Center for the
Evaluation of Alternative Toxicological Methods. Sections 285l–2 to 285l–5 of this title may not
be construed as affecting the authorities of such
Director regarding ICCVAM that were in effect
on the day before December 19, 2000, except to
the extent inconsistent with sections 285l–2 to
285l–5 of this title.
(b) Purposes
The purposes of the ICCVAM shall be to—
(1) increase the efficiency and effectiveness
of Federal agency test method review;
(2) eliminate unnecessary duplicative efforts
and share experiences between Federal regulatory agencies;
(3) optimize utilization of scientific expertise outside the Federal Government;
(4) ensure that new and revised test methods
are validated to meet the needs of Federal
agencies; and
(5) reduce, refine, or replace the use of animals in testing, where feasible.
(c) Composition
The ICCVAM shall be composed of the heads of
the following Federal agencies (or their designees):
(1) Agency for Toxic Substances and Disease
Registry.
(2) Consumer Product Safety Commission.
(3) Department of Agriculture.
(4) Department of Defense.
(5) Department of Energy.
(6) Department of the Interior.
(7) Department of Transportation.
(8) Environmental Protection Agency.
(9) Food and Drug Administration.
(10) National Institute for Occupational
Safety and Health.
(11) National Institutes of Health.
(12) National Cancer Institute.
(13) National Institute of Environmental
Health Sciences.
(14) National Library of Medicine.
(15) Occupational Safety and Health Administration.
(16) Any other agency that develops, or employs tests or test data using animals, or regulates on the basis of the use of animals in toxicity testing.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Scientific Advisory Committee
(1) Establishment
The Director of the National Institute of Environmental Health Sciences shall establish a
Scientific Advisory Committee (referred to in
sections 285l–2 to 285l–5 of this title as the
‘‘SAC’’) to advise ICCVAM and the National
Toxicology Program Interagency Center for
the Evaluation of Alternative Toxicological
Methods regarding ICCVAM activities. The activities of the SAC shall be subject to provisions of the Federal Advisory Committee Act.
(2) Membership
(A) In general
The SAC shall be composed of the following voting members:
(i) At least one knowledgeable representative having a history of expertise, development, or evaluation of new or revised or
alternative test methods from each of—
(I) the personal care, pharmaceutical,
industrial chemicals, or agriculture industry;
(II) any other industry that is regulated by the Federal agencies specified in
subsection (c) of this section; and
(III) a national animal protection organization
established
under
section
501(c)(3) of title 26.
(ii) Representatives (selected by the Director of the National Institute of Environmental Health Sciences) from an academic institution, a State government
agency, an international regulatory body,
or any corporation developing or marketing new or revised or alternative test
methodologies, including contract laboratories.
(B) Nonvoting ex officio members
The membership of the SAC shall, in addition to voting members under subparagraph
(A), include as nonvoting ex officio members
the agency heads specified in subsection (c)
of this section (or their designees).
(e) Duties
The ICCVAM shall, consistent with the purposes described in subsection (b) of this section,
carry out the following functions:
(1) Review and evaluate new or revised or alternative test methods, including batteries of
tests and test screens, that may be acceptable
for specific regulatory uses, including the coordination of technical reviews of proposed
new or revised or alternative test methods of
interagency interest.
(2) Facilitate appropriate interagency and
international harmonization of acute or
chronic toxicological test protocols that encourage the reduction, refinement, or replacement of animal test methods.
(3) Facilitate and provide guidance on the
development of validation criteria, validation
studies and processes for new or revised or alternative test methods and help facilitate the
acceptance of such scientifically valid test
methods and awareness of accepted test methods by Federal agencies and other stakeholders.

§ 285l–4

(4) Submit ICCVAM test recommendations
for the test method reviewed by the ICCVAM,
through expeditious transmittal by the Secretary of Health and Human Services (or the
designee of the Secretary), to each appropriate
Federal agency, along with the identification
of specific agency guidelines, recommendations, or regulations for a test method, including batteries of tests and test screens, for
chemicals or class of chemicals within a regulatory framework that may be appropriate for
scientific improvement, while seeking to reduce, refine, or replace animal test methods.
(5) Consider for review and evaluation, petitions received from the public that—
(A) identify a specific regulation, recommendation, or guideline regarding a regulatory mandate; and
(B) recommend new or revised or alternative test methods and provide valid scientific evidence of the potential of the test
method.
(6) Make available to the public final
ICCVAM test recommendations to appropriate
Federal agencies and the responses from the
agencies regarding such recommendations.
(7) Prepare reports to be made available to
the public on its progress under sections 285l–2
to 285l–5 of this title. The first report shall be
completed not later than 12 months after December 19, 2000, and subsequent reports shall
be completed biennially thereafter.
(Pub. L. 106–545, § 3, Dec. 19, 2000, 114 Stat. 2721.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (d)(1), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
as amended, which is set out in the Appendix to Title
5, Government Organization and Employees.
CODIFICATION
Section was enacted as part of the ICCVAM Authorization Act of 2000, and not as part of the Public Health
Service Act which comprises this chapter.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 285l–4. Federal agency action
(a) Identification of tests
With respect to each Federal agency carrying
out a program that requires or recommends
acute or chronic toxicological testing, such
agency shall, not later than 180 days after receiving an ICCVAM test recommendation, identify and forward to the ICCVAM any relevant

§ 285l–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

test method specified in a regulation or industry-wide guideline which specifically, or in practice requires, recommends, or encourages the
use of an animal acute or chronic toxicological
test method for which the ICCVAM test recommendation may be added or substituted.
(b) Alternatives
Each Federal agency carrying out a program
described in subsection (a) of this section shall
promote and encourage the development and use
of alternatives to animal test methods (including batteries of tests and test screens), where
appropriate, for the purpose of complying with
Federal statutes, regulations, guidelines, or recommendations (in each instance, and for each
chemical class) if such test methods are found to
be effective for generating data, in an amount
and of a scientific value that is at least equivalent to the data generated from existing tests,
for hazard identification, dose-response assessment, or risk assessment purposes.
(c) Test method validation
Each Federal agency carrying out a program
described in subsection (a) of this section shall
ensure that any new or revised acute or chronic
toxicity test method, including animal test
methods and alternatives, is determined to be
valid for its proposed use prior to requiring, recommending, or encouraging the application of
such test method.
(d) Review
Not later than 180 days after receipt of an
ICCVAM test recommendation, a Federal agency
carrying out a program described in subsection
(a) of this section shall review such recommendation and notify the ICCVAM in writing of
its findings.
(e) Recommendation adoption
Each Federal agency carrying out a program
described in subsection (a) of this section, or its
specific regulatory unit or units, shall adopt the
ICCVAM test recommendation unless such Federal agency determines that—
(1) the ICCVAM test recommendation is not
adequate in terms of biological relevance for
the regulatory goal authorized by that agency,
or mandated by Congress;
(2) the ICCVAM test recommendation does
not generate data, in an amount and of a scientific value that is at least equivalent to the
data generated prior to such recommendation,
for the appropriate hazard identification, doseresponse assessment, or risk assessment purposes as the current test method recommended or required by that agency;
(3) the agency does not employ, recommend,
or require testing for that class of chemical or
for the recommended test endpoint; or
(4) the ICCVAM test recommendation is unacceptable for satisfactorily fulfilling the test
needs for that particular agency and its respective congressional mandate.
(Pub. L. 106–545, § 4, Dec. 19, 2000, 114 Stat. 2723.)

Page 576

§ 285l–5. Application
(a) Application
Sections 285l–2 to 285l–5 of this title shall not
apply to research, including research performed
using biotechnology techniques, or research related to the causes, diagnosis, treatment, control, or prevention of physical or mental diseases or impairments of humans or animals.
(b) Use of test methods
Nothing in sections 285l–2 to 285l–5 of this title
shall prevent a Federal agency from retaining
final authority for incorporating the test methods recommended by the ICCVAM in the manner
determined to be appropriate by such Federal
agency or regulatory body.
(c) Limitation
Nothing in sections 285l–2 to 285l–5 of this title
shall be construed to require a manufacturer
that is currently not required to perform animal
testing to perform such tests. Nothing in sections 285l–2 to 285l–5 of this title shall be construed to require a manufacturer to perform redundant endpoint specific testing.
(d) Submission of tests and data
Nothing in sections 285l–2 to 285l–5 of this title
precludes a party from submitting a test method
or scientific data directly to a Federal agency
for use in a regulatory program.
(Pub. L. 106–545, § 5, Dec. 19, 2000, 114 Stat. 2724.)
CODIFICATION
Section was enacted as part of the ICCVAM Authorization Act of 2000, and not as part of the Public Health
Service Act which comprises this chapter.

§ 285l–6. Methods of controlling certain insect
and vermin populations
The Director of the Institute shall conduct or
support research to identify or develop methods
of controlling insect and vermin populations
that transmit to humans diseases that have significant adverse health consequences.
(July 1, 1944, ch. 373, title IV, § 463B, as added
Pub. L. 108–75, § 3, Aug. 15, 2003, 117 Stat. 902.)
SUBPART 13—NATIONAL INSTITUTE ON DEAFNESS
AND OTHER COMMUNICATION DISORDERS

§ 285m. Purpose of Institute
The general purpose of the National Institute
on Deafness and Other Communication Disorders (hereafter referred to in this subpart as
the ‘‘Institute’’) is the conduct and support of
research and training, the dissemination of
health information, and other programs with respect to disorders of hearing and other communication processes, including diseases affecting
hearing, balance, voice, speech, language, taste,
and smell.
(July 1, 1944, ch. 373, title IV, § 464, as added Pub.
L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2769, and
Pub. L. 100–607, title I, § 101(4), Nov. 4, 1988, 102
Stat. 3049; amended Pub. L. 100–690, title II,
§ 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238.)

CODIFICATION

CODIFICATION

Section was enacted as part of the ICCVAM Authorization Act of 2000, and not as part of the Public Health
Service Act which comprises this chapter.

Pub. L. 100–553 and Pub. L. 100–607 contained identical
provisions enacting this section. See 1988 Amendment
note below.

Page 577

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1988—Pub. L. 100–690 amended this section to read as
if the amendments made by Pub. L. 100–607, which enacted this section, had not been enacted. See Codification note above.
SHORT TITLE OF 1988 AMENDMENT
For short title of Pub. L. 100–553 which enacted this
subpart and amended sections 281 and 285j of this title
as the ‘‘National Deafness and Other Communication
Disorders Act of 1988’’, see section 1 of Pub. L. 100–553,
set out as a note under section 201 of this title.
EFFECT OF ENACTMENT OF SIMILAR PROVISIONS
Section 2613(b) of Pub. L. 100–690 provided that:
‘‘(1) Paragraphs (2) and (3) shall take effect immediately after the enactment of both the bill, S. 1727, of
the One Hundredth Congress [Pub. L. 100–553, approved
Oct. 28, 1988], and the Health Omnibus Programs Extension of 1988 [Pub. L. 100–607, approved Nov. 4, 1988].
‘‘(2)(A) The provisions of the Public Health Service
Act referred to in subparagraph (B), as similarly
amended by the enactment of the bill, S. 1727, of the
One Hundredth Congress, by subtitle A of title I of the
Health Omnibus Programs Extension of 1988, and by
subsection (a)(1) of this section, are amended to read as
if the amendments made by such subtitle A and such
subsection (a)(1) had not been enacted.
‘‘(B) The provisions of the Public Health Service Act
referred to in subparagraph (A) are—
‘‘(A) sections 401(b)(1) and 457 [sections 281(b)(1) and
285j of this title];
‘‘(B) part C of title IV [this part]; and
‘‘(C) the heading for subpart 10 of such part C [42
U.S.C. prec. 285j].
‘‘(3) Subsection (a)(2) of this section [set out below] is
repealed.’’
TRANSITIONAL AND SAVINGS PROVISIONS
Section 3 of Pub. L. 100–553 provided that:
‘‘(a) TRANSFER OF PERSONNEL, ASSETS, AND LIABILITIES.—Personnel employed by the National Institutes
of Health in connection with the functions vested under
section 2 [enacting this subpart and amending sections
281 and 285j of this title] in the Director of the National
Institute on Deafness and Other Communication Disorders, and assets, property, contracts, liabilities,
records, unexpended balances of appropriations, authorizations, allocations, and other funds of the National Institutes of Health, arising from or employed,
held, used, available to, or to be made available, in connection with such functions shall be transferred to the
Director for appropriate allocation. Unexpended funds
transferred under this subsection shall be used only for
the purposes for which the funds were originally authorized and appropriated.
‘‘(b) SAVINGS PROVISIONS.—With respect to functions
vested under section 1 [probably means section 2, enacting this subpart and amending sections 281 and 285j
of this title] in the Director of the National Institute
on Deafness and Other Communication Disorders, all
orders, rules, regulations, grants, contracts, certificates, licenses, privileges, and other determinations,
actions, or official documents, that have been issued,
made, granted, or allowed to become effective, and that
are effective on the date of the enactment of this Act
[Oct. 28, 1988], shall continue in effect according to
their terms unless changed pursuant to law.’’
Section 2612(a)(2) of Pub. L. 100–690, which enacted
provisions that were substantially identical to the
transitional and savings provisions above, was repealed
by section 2613(b)(3) of Pub. L. 100–690.

§ 285m–1. National Deafness and Other Communication Disorders Program
(a) The Director of the Institute, with the advice of the Institute’s advisory council, shall establish a National Deafness and Other Commu-

§ 285m–1

nication Disorders Program (hereafter in this
section referred to as the ‘‘Program’’). The Director or 1 the Institute shall, with respect to
the Program, prepare and transmit to the Director of NIH a plan to initiate, expand, intensify
and coordinate activities of the Institute respecting disorders of hearing (including tinnitus) and other communication processes, including diseases affecting hearing, balance, voice,
speech, language, taste, and smell. The plan
shall include such comments and recommendations as the Director of the Institute determines
appropriate. The Director of the Institute shall
periodically review and revise the plan and shall
transmit any revisions of the plan to the Director of NIH.
(b) Activities under the Program shall include—
(1) investigation into the etiology, pathology, detection, treatment, and prevention of
all forms of disorders of hearing and other
communication processes, primarily through
the support of basic research in such areas as
anatomy,
audiology,
biochemistry,
bioengineering, epidemiology, genetics, immunology, microbiology, molecular biology, the neurosciences, otolaryngology, psychology, pharmacology, physiology, speech and language
pathology, and any other scientific disciplines
that can contribute important knowledge to
the understanding and elimination of disorders of hearing and other communication
processes;
(2) research into the evaluation of techniques (including surgical, medical, and behavioral approaches) and devices (including hearing aids, implanted auditory and nonauditory
prosthetic devices and other communication
aids) used in diagnosis, treatment, rehabilitation, and prevention of disorders of hearing
and other communication processes;
(3) research into prevention, and early detection and diagnosis, of hearing loss and speech
and language disturbances (including stuttering) and research into preventing the effects of
such disorders on learning and learning disabilities with extension of programs for appropriate referral and rehabilitation;
(4) research into the detection, treatment,
and prevention of disorders of hearing and
other communication processes in the growing
elderly population with extension of rehabilitative programs to ensure continued effective
communication skills in such population;
(5) research to expand knowledge of the effects of environmental agents that influence
hearing or other communication processes;
and
(6) developing and facilitating intramural
programs on clinical and fundamental aspects
of disorders of hearing and all other communication processes.
(July 1, 1944, ch. 373, title IV, § 464A, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2769,
and Pub. L. 100–607, title I, § 101(4), Nov. 4, 1988,
102 Stat. 3049; amended Pub. L. 100–690, title II,
§ 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238.)
1 So

in original. Probably should be ‘‘of’’.

§ 285m–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE
CODIFICATION

Pub. L. 100–553 and Pub. L. 100–607 contained identical
provisions enacting this section. See 1988 Amendment
note below.
AMENDMENTS
1988—Pub. L. 100–690 amended this section to read as
if the amendments made by Pub. L. 100–607, which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.

§ 285m–2. Data System and Information Clearinghouse
(a) The Director of the Institute shall establish a National Deafness and Other Communication Disorders Data System for the collection,
storage, analysis, retrieval, and dissemination
of data derived from patient populations with
disorders of hearing or other communication
processes, including where possible, data involving general populations for the purpose of identifying individuals at risk of developing such
disorders.
(b) The Director of the Institute shall establish a National Deafness and Other Communication Disorders Information Clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of disorders of hearing and other
communication processes by health professionals, patients, industry, and the public.
(July 1, 1944, ch. 373, title IV, § 464B, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2770,
and Pub. L. 100–607, title I, § 101(4), Nov. 4, 1988,
102 Stat. 3050; amended Pub. L. 100–690, title II,
§ 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238.)
CODIFICATION
Pub. L. 100–553 and Pub. L. 100–607 contained identical
provisions enacting this section. See 1988 Amendment
note below.
AMENDMENTS
1988—Pub. L. 100–690 amended this section to read as
if the amendments made by Pub. L. 100–607, which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.

§ 285m–3. Multipurpose deafness and other communication disorders center
(a) Development, modernization and operation;
‘‘modernization’’ defined
The Director of the Institute shall, after consultation with the advisory council for the Institute, provide for the development, modernization, and operation (including care required for
research) of new and existing centers for studies
of disorders of hearing and other communication
processes. For purposes of this section, the term
‘‘modernization’’ means the alteration, remodel-

Page 578

ing, improvement, expansion, and repair of existing buildings and the provision of equipment
for such buildings to the extent necessary to
make them suitable for use as centers described
in the preceding sentence.
(b) Use of facilities; qualifications
Each center assisted under this section shall—
(1) use the facilities of a single institution or
a consortium of cooperating institutions; and
(2) meet such qualifications as may be prescribed by the Secretary.
(c) Requisite programs
Each center assisted under this section shall,
at least, conduct—
(1) basic and clinical research into the cause
diagnosis, early detection, prevention, control
and treatment of disorders of hearing and
other communication processes and complications resulting from such disorders, including
research into rehabilitative aids, implantable
biomaterials, auditory speech processors,
speech production devices, and other otolaryngologic procedures;
(2) training programs for physicians, scientists, and other health and allied health professionals;
(3) information and continuing education
programs for physicians and other health and
allied health professionals who will provide
care for patients with disorders of hearing or
other communication processes; and
(4) programs for the dissemination to the
general public of information—
(A) on the importance of early detection of
disorders of hearing and other communication processes, of seeking prompt treatment,
rehabilitation, and of following an appropriate regimen; and
(B) on the importance of avoiding exposure
to noise and other environmental toxic
agents that may affect disorders of hearing
or other communication processes.
(d) Stipends
A center may use funds provided under subsection (a) of this section to provide stipends for
health professionals enrolled in training programs described in subsection (c)(2) of this section.
(e) Discretionary programs
Each center assisted under this section may
conduct programs—
(1) to establish the effectiveness of new and
improved methods of detection, referral, and
diagnosis of individuals at risk of developing
disorders of hearing or other communication
processes; and
(2) to disseminate the results of research,
screening, and other activities, and develop
means of standardizing patient data and recordkeeping.
(f) Equitable geographical distribution; needs of
elderly and children
The Director of the Institute shall, to the extent practicable, provide for an equitable geographical distribution of centers assisted under
this section. The Director shall give appropriate
consideration to the need for centers especially
suited to meeting the needs of the elderly, and

Page 579

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of children (particularly with respect to their
education and training), affected by disorders of
hearing or other communication processes.
(g) Period of support; recommended extensions
of peer review group
Support of a center under this section may be
for a period not to exceed seven years. Such period may be extended by the Director of the Institute for one or more additional periods of not
more than five years if the operations of such
center have been reviewed by an appropriate
technical and scientific peer review group established by the Director, with the advice of the Institute’s advisory council, if such group has recommended to the Director that such period
should be extended.
(July 1, 1944, ch. 373, title IV, § 464C, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2771,
and Pub. L. 100–607, title I, § 101(4), Nov. 4, 1988,
102 Stat. 3050; amended Pub. L. 100–690, title II,
§ 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238.)
CODIFICATION
Pub. L. 100–553 and Pub. L. 100–607 contained identical
provisions enacting this section. See 1988 Amendment
note below.
AMENDMENTS
1988—Pub. L. 100–690 amended this section to read as
if the amendments made by Pub. L. 100–607, which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.

§ 285m–4. National Institute on Deafness and
Other Communication Disorders Advisory
Board
(a) Establishment
The Secretary shall establish in the Institute
the National Deafness and Other Communication Disorders Advisory Board (hereafter in this
section referred to as the ‘‘Advisory Board’’).
(b) Composition; qualifications; appointed and ex
officio members
The Advisory Board shall be composed of
eighteen appointed members and nonvoting ex
officio members as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who
are scientists, physicians, and other health
and rehabilitation professionals, who are not
officers or employees of the United States,
and who represent the specialties and disciplines relevant to deafness and other communication disorders, including not less
than two persons with a communication disorder; and
(B) six members from the general public
who are knowledgeable with respect to such
disorders, including not less than one person
with a communication disorder and not less
than one person who is a parent of an individual with such a disorder.
Of the appointed members, not less than five
shall by virtue of training or experience be

§ 285m–4

knowledgeable in diagnoses and rehabilitation
of communication disorders, education of the
hearing, speech, or language impaired, public
health, public information, community program development, occupational hazards to
communications senses, or the aging process.
(2) The following shall be ex officio members
of each Advisory Board:
(A) The Assistant Secretary for Health,
the Director of NIH, the Director of the National Institute on Deafness and Other Communication Disorders, the Director of the
Centers for Disease Control and Prevention,
the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers).
(B) Such other officers and employees of
the United States as the Secretary determines necessary for the Advisory Board to
carry out its functions.
(c) Compensation
Members of an Advisory Board who are officers or employees of the Federal Government
shall serve as members of the Advisory Board
without compensation in addition to that received in their regular public employment.
Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18
of the General Schedule for each day (including
traveltime) they are engaged in the performance
of their duties as members of the Board.
(d) Term of office; vacancies
The term of office of an appointed member of
the Advisory Board is four years, except that no
term of office may extend beyond the expiration
of the Advisory Board. Any member appointed
to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A
member may serve after the expiration of the
member’s term until a successor has taken office. If a vacancy occurs in the Advisory Board,
the Secretary shall make an appointment to fill
the vacancy not later than 90 days from the date
the vacancy occurred.
(e) Chairman
The members of the Advisory Board shall select a chairman from among the appointed
members.
(f) Personnel; executive director; professional
and clerical staff members; consultants; information and administrative support services and facilities
The Secretary shall, after consultation with
and consideration of the recommendations of
the Advisory Board, provide the Advisory Board
with an executive director and one other professional staff member. In addition, the Secretary
shall, after consultation with and consideration
of the recommendations of the Advisory Board,
provide the Advisory Board with such additional
professional staff members, such clerical staff
members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines
are necessary for the Advisory Board to carry
out its functions.

§ 285m–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(g) Meetings
The Advisory Board shall meet at the call of
the chairman or upon request of the Director of
the Institute, but not less often than four times
a year.
(h) Functions
The Advisory Board shall—
(1) review and evaluate the implementation
of the plan prepared under section 285m–1(a) of
this title and periodically update the plan to
ensure its continuing relevance;
(2) for the purpose of assuring the most effective use and organization of resources respecting deafness and other communication
disorders, advise and make recommendations
to the Congress, the Secretary, the Director of
NIH, the Director of the Institute, and the
heads of other appropriate Federal agencies
for the implementation and revision of such
plan; and
(3) maintain liaison with other advisory bodies related to Federal agencies involved in the
implementation of such plan and with key
non-Federal entities involved in activities affecting the control of such disorders.
(i) Subcommittee activities; workshops and conferences; collection of data
In carrying out its functions, the Advisory
Board may establish subcommittees, convene
workshops and conferences, and collect data.
Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to
enable them to carry out their activities.
(j)
Repealed.
Pub.
L.
109–482,
title
I,
§ 104(b)(1)(J), Jan. 15, 2007, 120 Stat. 3693
(k) Commencement of existence
The National Deafness and Other Communication Disorders Advisory Board shall be established not later than April 1, 1989.
(July 1, 1944, ch. 373, title IV, § 464D, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2772,
and Pub. L. 100–690, title II, § 2613(a)(1), Nov. 18,
1988, 102 Stat. 4235; amended Pub. L. 100–690, title
II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub.
L. 101–93, § 5(b), Aug. 16, 1989, 103 Stat. 611; Pub.
L. 102–405, title III, § 302(e)(1), Oct. 9, 1992, 106
Stat. 1985; Pub. L. 102–531, title III, § 312(d)(8),
Oct. 27, 1992, 106 Stat. 3504; Pub. L. 103–43, title
XX, § 2008(b)(8), June 10, 1993, 107 Stat. 211; Pub.
L. 109–482, title I, § 104(b)(1)(J), Jan. 15, 2007, 120
Stat. 3693.)
CODIFICATION
Pub. L. 100–553 and section 2613(a)(1) of Pub. L. 100–690
contained identical provisions enacting this section.
See 1988 Amendment note below.
AMENDMENTS
2007—Subsec. (j). Pub. L. 109–482 struck out subsec. (j)
which read as follows: ‘‘The Advisory Board shall prepare an annual report for the Secretary which—
‘‘(1) describes the Advisory Board’s activities in the
fiscal year for which the report is made;
‘‘(2) describes and evaluates the progress made in
such fiscal year in research, treatment, education,
and training with respect to the deafness and other
communication disorders;

Page 580

‘‘(3) summarizes and analyzes expenditures made by
the Federal Government for activities respecting
such disorders in such fiscal year; and
‘‘(4) contains the Advisory Board’s recommendations (if any) for changes in the plan prepared under
section 285m–1(a) of this title.’’
1993—Subsec. (b)(2)(A). Pub. L. 103–43 substituted
‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1992—Subsec. (b)(2)(A). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–405 substituted ‘‘Under Secretary for
Health’’ for ‘‘Chief Medical Director’’.
1989—Subsec. (k). Pub. L. 101–93 substituted ‘‘April 1,
1989’’ for ‘‘90 days after the date of the enactment of the
National Institute on Deafness and Other Communication Disorders Act’’.
1988—Pub. L. 100–690, § 2613(b)(2), amended this section
to read as if the amendments made by Pub. L. 100–690,
§ 2613(a)(1), which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by section 2613(b)(2)
of Pub. L. 100–690, see section 2613(b)(1) of Pub. L.
100–690, set out as an Effect of Enactment of Similar
Provisions note under section 285m of this title.
TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463,
Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 285m–5. Interagency Coordinating Committee
(a) Establishment
The Secretary may establish a committee to
be known as the Deafness and Other Communication Disorders Interagency Coordinating
Committee (hereafter in this section referred to
as the ‘‘Coordinating Committee’’).
(b) Functions
The Coordinating Committee shall, with respect to deafness and other communication disorders—
(1) provide for the coordination of the activities of the national research institutes; and

Page 581

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) coordinate the aspects of all Federal
health programs and activities relating to
deafness and other communication disorders
in order to assure the adequacy and technical
soundness of such programs and activities and
in order to provide for the full communication
and exchange of information necessary to
maintain adequate coordination of such programs and activities.
(c) Composition
The Coordinating Committee shall be composed of the directors of each of the national research institutes and divisions involved in research with respect to deafness and other communication disorders and representatives of all
other Federal departments and agencies whose
programs involve health functions or responsibilities relevant to deafness and other communication disorders.
(d) Chairman; meetings
The Coordinating Committee shall be chaired
by the Director of NIH (or the designee of the
Director). The Committee shall meet at the call
of the chair, but not less often than four times
a year.
(July 1, 1944, ch. 373, title IV, § 464E, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2774,
and Pub. L. 100–690, title II, § 2613(a)(1), Nov. 18,
1988, 102 Stat. 4237; amended Pub. L. 100–690, title
II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub.
L. 103–43, title XX, § 2008(b)(9), June 10, 1993, 107
Stat. 211; Pub. L. 109–482, title I, § 104(b)(1)(K),
Jan. 15, 2007, 120 Stat. 3693.)
CODIFICATION
Pub. L. 100–553 and section 2613(a)(1) of Pub. L. 100–690
contained identical provisions enacting this section.
See 1988 Amendment note below.
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out subsec.
(e) which read as follows: ‘‘Not later than 120 days after
the end of each fiscal year, the Coordinating Committee shall prepare and transmit to the Secretary, the Director of NIH, the Director of the Institute, and the advisory council for the Institute a report detailing the
activities of the Committee in such fiscal year in carrying out subsection (b) of this section.’’
1993—Subsecs. (d), (e). Pub. L. 103–43 inserted ‘‘Coordinating’’ before ‘‘Committee’’ in first sentence of subsec. (d) and before first reference to ‘‘Committee’’ in
subsec. (e).
1988—Pub. L. 100–690, § 2613(b)(2), amended this section
to read as if the amendments made by Pub. L. 100–690,
§ 2613(a)(1), which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by section 2613(b)(2)
of Pub. L. 100–690, see section 2613(b)(1) of Pub. L.
100–690, set out as an Effect of Enactment of Similar
Provisions note under section 285m of this title.

§ 285m–6. Limitation on administrative expenses
With respect to amounts appropriated for a
fiscal year for the National Institutes of Health,

§ 285n

the limitation established in section 284c(a)(1) of
this title on the expenditure of such amounts for
administrative expenses shall apply to administrative expenses of the National Institute on
Deafness and Other Communication Disorders.
(July 1, 1944, ch. 373, title IV, § 464F, as added
Pub. L. 100–553, § 2(4), Oct. 28, 1988, 102 Stat. 2774,
and Pub. L. 100–690, title II, § 2613(a)(1), Nov. 18,
1988, 102 Stat. 4238; amended Pub. L. 100–690, title
II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub.
L. 103–43, title IV, § 403(b)(2), June 10, 1993, 107
Stat. 158.)
CODIFICATION
Pub. L. 100–553 and section 2613(a)(1) of Pub. L. 100–690
contained identical provisions enacting this section.
See 1988 Amendment note below.
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘section 284c(a)(1)’’
for ‘‘section 284c(b)(1)’’.
1988—Pub. L. 100–690, § 2613(b)(2), amended this section
to read as if the amendments made by Pub. L. 100–690,
§ 2613(a)(1), which enacted this section, had not been enacted. See Codification note above.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by section 2613(b)(2)
of Pub. L. 100–690, see section 2613(b)(1) of Pub. L.
100–690, set out as an Effect of Enactment of Similar
Provisions note under section 285m of this title.
SUBPART 14—NATIONAL INSTITUTE ON ALCOHOL
ABUSE AND ALCOHOLISM

§ 285n. Purpose of Institute
(a) In general
The general purpose of the National Institute
on Alcohol Abuse and Alcoholism (hereafter in
this subpart referred to as the ‘‘Institute’’) is
the conduct and support of biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of alcohol
abuse and the treatment of alcoholism.
(b) Research program
The research program established under this
subpart shall encompass the social, behavioral,
and biomedical etiology, mental and physical
health consequences, and social and economic
consequences of alcohol abuse and alcoholism.
In carrying out the program, the Director of the
Institute is authorized to—
(1) collect and disseminate through publications and other appropriate means (including
the development of curriculum materials), information as to, and the practical application
of, the research and other activities under the
program;
(2) make available research facilities of the
Public Health Service to appropriate public
authorities, and to health officials and scientists engaged in special study;
(3) make grants to universities, hospitals,
laboratories, and other public or nonprofit institutions, and to individuals for such research
projects as are recommended by the National
Advisory Council on Alcohol Abuse and Alcoholism, giving special consideration to
projects relating to—
(A) the relationship between alcohol abuse
and domestic violence,

§ 285n

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the effects of alcohol use during pregnancy,
(C) the impact of alcoholism and alcohol
abuse on the family, the workplace, and systems for the delivery of health services,
(D) the relationship between the abuse of
alcohol and other drugs,
(E) the effect on the incidence of alcohol
abuse and alcoholism of social pressures,
legal requirements respecting the use of alcoholic beverages, the cost of such beverages, and the economic status and education of users of such beverages,
(F) the interrelationship between alcohol
use and other health problems,
(G) the comparison of the cost and effectiveness of various treatment methods for
alcoholism and alcohol abuse and the effectiveness of prevention and intervention programs for alcoholism and alcohol abuse,
(H) alcoholism and alcohol abuse among
women;
(4) secure from time to time and for such periods as he deems advisable, the assistance and
advice of experts, scholars, and consultants
from the United States or abroad;
(5) promote the coordination of research programs conducted by the Institute, and similar
programs conducted by the National Institute
of Drug Abuse and by other departments,
agencies, organizations, and individuals, including all National Institutes of Health research activities which are or may be related
to the problems of individuals suffering from
alcoholism or alcohol abuse or those of their
families or the impact of alcohol abuse on
other health problems;
(6) conduct an intramural program of biomedical, behavioral, epidemiological, and social research, including research into the most
effective means of treatment and service delivery, and including research involving
human subjects, which is—
(A) located in an institution capable of
providing all necessary medical care for such
human subjects, including complete 24-hour
medical diagnostic services by or under the
supervision of physicians, acute and intensive medical care, including 24-hour emergency care, psychiatric care, and such other
care as is determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
(B) associated with an accredited medical
or research training institution;
(7) for purposes of study, admit and treat at
institutions, hospitals, and stations of the
Public Health Service, persons not otherwise
eligible for such treatment;
(8) provide to health officials, scientists, and
appropriate public and other nonprofit institutions and organizations, technical advice and
assistance on the application of statistical and
other scientific research methods to experiments, studies, and surveys in health and medical fields;
(9) enter into contracts under this subchapter without regard to section 3324(a) and
(b) of title 31 and section 6101 of title 41; and
(10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and

Page 582

Alcoholism, such additional means as he
deems necessary or appropriate to carry out
the purposes of this section.
(c) Collaboration
The Director of the Institute shall collaborate
with the Administrator of the Substance Abuse
and Mental Health Services Administration in
focusing the services research activities of the
Institute and in disseminating the results of
such research to health professionals and the
general public.
(July 1, 1944, ch. 373, title IV, § 464H, as added
and amended Pub. L. 102–321, title I, § 122(a), (b),
July 10, 1992, 106 Stat. 358, 359; Pub. L. 102–352,
§ 2(a)(1), Aug. 26, 1992, 106 Stat. 938; Pub. L.
109–482, title I, § 103(b)(32), Jan. 15, 2007, 120 Stat.
3688.)
CODIFICATION
Section 290bb(b) of this title, which was transferred
to subsec. (b) of this section and amended by Pub. L.
102–321, was based on act July 1, 1944, ch. 373, title V,
§ 510, formerly Pub. L. 91–616, title V, § 501(b), as added
Pub. L. 94–371, § 7, July 26, 1976, 90 Stat. 1038; amended
Pub. L. 95–622, title II, § 268(d), Nov. 9, 1978, 92 Stat. 3437;
Pub. L. 96–180, § 14(b), Jan. 2, 1980, 93 Stat. 1305; renumbered § 510(b) of act July 1, 1944, and amended Apr. 26,
1983, Pub. L. 98–24, § 2(b)(9), 97 Stat. 179; Oct. 19, 1984,
Pub. L. 98–509, title II, § 205(a)(1), 98 Stat. 2361.
In subsec. (b)(9), ‘‘section 3324(a) and (b) of title 31
and section 6101 of title 41’’ substituted for ‘‘sections
3648 and 3709 of the Revised Statutes (31 U.S.C. 529; 41
U.S.C. 5)’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13,
1982, 96 Stat. 1067, which Act enacted Title 31, Money
and Finance, and Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out subsec.
(d) which related to authorization of appropriations
and allocation for health services research.
1992—Subsec. (a). Pub. L. 102–352 substituted ‘‘Institute on Alcohol’’ for ‘‘Institute of Alcohol’’.
Subsec. (b). Pub. L. 102–321, § 122(b)(1), (2)(A), transferred subsec. (b) of section 290bb of this title to subsec.
(b) of this section, substituted ‘‘(b) RESEARCH PROGRAM.—The research program established under this
subpart shall encompass the social, behavioral, and biomedical etiology, mental and physical health consequences, and social and economic consequences of alcohol abuse and alcoholism. In carrying out the program,
the Director of the Institute is authorized’’ for ‘‘(b) In
carrying out the program described in subsection (a) of
this section, the Secretary, acting through the Institute, is authorized’’ in introductory provisions, and
substituted a semicolon for period at end of par. (3)(H).
Subsecs. (c), (d). Pub. L. 102–321, § 122(b)(2)(B), added
subsecs. (c) and (d).
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Section 3 of Pub. L. 102–352 provided that: ‘‘The
amendments made by—
‘‘(1) subsection (a) of section 2 [amending this section and sections 285n–2, 285o, 285o–2, 285p, 290aa–1,
290aa–3, 300x–7, 300x–27, 300x–33, 300x–53, and 300y of
this title], shall take effect immediately upon the effectuation of the amendments made by titles I and II
of the ADAMHA Reorganization Act [Pub. L. 102–321,

Page 583

TITLE 42—THE PUBLIC HEALTH AND WELFARE

see Effective Date of 1992 Amendment note set out
under section 236 of this title]; and
‘‘(2) subsections (b) and (c) of section 2 [amending
sections 290cc–21, 290cc–28, and 290cc–30 of this title
and provisions set out as notes under sections 290aa
and 300x of this title], shall take effect on the date of
enactment of this Act [Aug. 26, 1992].’’

§ 285n–2

under section 284b 1 of this title a description of
the prevention activities of the Institute, including a description of the staff and resources
allocated to those activities.

EFFECTIVE DATE

(July 1, 1944, ch. 373, title IV, § 464I, as added
Pub. L. 102–321, title I, § 122(c), July 10, 1992, 106
Stat. 359.)

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.

REQUIRED ALLOCATIONS FOR HEALTH SERVICES
RESEARCH
Pub. L. 103–43, title XX, § 2016(b), June 10, 1993, 107
Stat. 218, provided that, with respect to the allocation
for health services research required in former subsec.
(d)(2) of this section and former sections 285o(d)(2) and
285p(f)(2) of this title, the term ‘‘15 percent’’ appearing
in each of such provisions was deemed to be 12 percent
in the case of allocations for fiscal year 1993.
STUDY ON FETAL ALCOHOL EFFECT AND FETAL
ALCOHOL SYNDROME
Section 705 of Pub. L. 102–321 directed Secretary of
Health and Human Services to enter into a contract
with a public or nonprofit private entity to conduct a
study on the prevalence of fetal alcohol effect and fetal
alcohol syndrome in the general population of the
United States and on the adequacy of Federal efforts to
reduce the incidence of such conditions (including efforts regarding appropriate training for health care
providers in identifying such effect or syndrome), and
to ensure that a report outlining this study be submitted to Congress not later than 18 months after July 10,
1992.
ALCOHOLISM AND ALCOHOL ABUSE TREATMENT STUDY
Pub. L. 99–570, title IV, § 4022, Oct. 27, 1986, 100 Stat.
3207–124, directed Secretary of Health and Human Services, acting through Director of National Institute on
Alcohol Abuse and Alcoholism, to conduct a study of
alternative approaches for alcoholism and alcohol
abuse treatment and rehabilitation and of financing alternatives including policies and experiences of third
party insurers and State and municipal governments;
to recommend policies and programs for research, planning, administration, and reimbursement for treatment
and rehabilitation; to request National Academy of
Sciences to conduct such study in consultation with
Director of National Institute on Alcohol Abuse and Alcoholism under an arrangement entered into with consent of Academy that actual expenses of Academy will
be paid by Secretary and that Academy would submit
a final report to Secretary no later than 24 months
after the arrangement was entered into; and to transmit a final report to Congress no later than 30 days
after receiving Academy’s report.

§ 285n–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate
Director for Prevention who shall be responsible
for the full-time coordination and promotion of
the programs in the Institute concerning the
prevention of alcohol abuse and alcoholism. The
Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or expertise
are experts in alcohol abuse and alcoholism or
the prevention of such.
(b) Biennial report
The Associate Director for Prevention shall
prepare for inclusion in the biennial report made

REFERENCES IN TEXT

EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285n–2. National Alcohol Research Centers;
mandatory grant for research of effects of alcohol on elderly
(a) Designation; procedures applicable for approval of applications
The Secretary acting through the Institute
may designate National Alcohol Research Centers for the purpose of interdisciplinary research
relating to alcoholism and other biomedical, behavioral, and social issues related to alcoholism
and alcohol abuse. No entity may be designated
as a Center unless an application therefor has
been submitted to, and approved by, the Secretary. Such an application shall be submitted
in such manner and contain such information as
the Secretary may reasonably require. The Secretary may not approve such an application unless—
(1) the application contains or is supported
by reasonable assurances that—
(A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social, and related disciplines,
long-term research on alcoholism and other
alcohol problems and to provide coordination of such research among such disciplines;
(B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis facilities) to carry
out the research plan contained in the application;
(C) the applicant has facilities and personnel to provide training in the prevention and
treatment of alcoholism and other alcohol
problems;
(D) the applicant has the capacity to train
predoctoral and postdoctoral students for
careers in research on alcoholism and other
alcohol problems;
(E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol problems for undergraduate and graduate students, and for medical
and osteopathic, nursing, social work, and
other specialized graduate students; and
(F) the applicant has the capacity to conduct programs of continuing education in
such medical, legal, and social service fields
as the Secretary may require.1
1 See
1 So

References in Text note below.
in original. The period probably should be ‘‘; and’’.

§ 285o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) the application contains a detailed fiveyear plan for research relating to alcoholism
and other alcohol problems.
(b) Annual grants; amount; limitation on uses
The Secretary shall, under such conditions as
the Secretary may reasonably require, make annual grants to Centers which have been designated under this section. No funds provided
under a grant under this subsection may be used
for the purchase of any land or the purchase,
construction, preservation, or repair of any
building. For the purposes of the preceding sentence, the term ‘‘construction’’ has the meaning
given that term by section 292a(1) 2 of this title.
The Secretary shall include in the grants made
under this section for fiscal years beginning
after September 30, 1981, a grant to a designated
Center for research on the effects of alcohol on
the elderly.
(July 1, 1944, ch. 373, title IV, § 464J, formerly
title V, § 511, formerly Pub. L. 91–616, title V,
§ 503, formerly § 504, as added Pub. L. 94–371, § 7,
July 26, 1976, 90 Stat. 1039; amended Pub. L.
95–622, title I, § 110(d), Nov. 9, 1978, 92 Stat. 3420;
Pub. L. 96–180, § 16, Jan. 2, 1980, 93 Stat. 1305; renumbered § 503 of Pub. L. 91–616 and amended
Pub. L. 97–35, title IX, § 965(b), (c), Aug. 13, 1981,
95 Stat. 594; renumbered § 511 of act July 1, 1944,
and amended Pub. L. 98–24, § 2(b)(9), Apr. 26, 1983,
97 Stat. 179; Pub. L. 99–570, title IV, § 4008, Oct.
27, 1986, 100 Stat. 3207–115; renumbered title IV,
§ 464J and amended Pub. L. 102–321, title I,
§ 122(d), July 10, 1992, 106 Stat. 360; Pub. L.
102–352, § 2(a)(2), Aug. 26, 1992, 106 Stat. 938.)
REFERENCES IN TEXT
Section 292a of this title, referred to in subsec. (b),
was in the original a reference to section 701 of act July
1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702,
relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see sections 292o and 295p of this title.
CODIFICATION
Section was formerly classified to section 290bb–1 of
this title prior to renumbering by Pub. L. 102–321.
Section was formerly classified to section 4587 of this
title prior to renumbering by Pub. L. 98–24.
Section was formerly classified to section 4588 of this
title prior to renumbering by Pub. L. 97–35.
AMENDMENTS
1992—Subsec. (b). Pub. L. 102–352 substituted ‘‘292a(1)’’
for ‘‘292a(2)’’.
Pub. L. 102–321, § 122(d)(2), struck ‘‘or rental’’ before
‘‘of any land’’.
1986—Subsec. (b). Pub. L. 99–570, § 4008(1), which directed that subsec. (b) be amended by striking out ‘‘or
rental’’ before ‘‘any land’’, could not be executed because ‘‘or rental’’ appeared before ‘‘of any land’’.
Pub. L. 99–570, § 4008(2), struck out ‘‘rental,’’ before
‘‘purchase’’.
1983—Subsec. (a). Pub. L. 98–24, § 2(b)(9)(B)(i), struck
out direction that, insofar as practicable, the Secretary
approve applications under this subsection in a manner
resulting in an equitable geographic distribution of
Centers.
2 See

References in Text note below.

Page 584

Subsec. (b). Pub. L. 98–24, § 2(b)(9)(B)(ii), (iii), struck
out provision that no annual grant to any Center might
exceed $1,500,000, and made a technical amendment to
reference to section 292a of this title to reflect the
transfer of this section to the Public Health Service
Act.
Subsec. (c). Pub. L. 98–24, § 2(b)(9)(B)(iv), struck out
subsec. (c) which authorized $6,000,000 for each of fiscal
years ending Sept. 30, 1977, 1978, and 1979, $8,000,000 for
fiscal year ending Sept. 30, 1980, and $9,000,000 for fiscal
year ending Sept. 30, 1981.
1981—Subsec. (b). Pub. L. 97–35, § 965(b), inserted provisions relating to grants made for fiscal years beginning after Sept. 30, 1981.
1980—Subsec. (a). Pub. L. 96–180, § 16(a), substituted:
in first sentence ‘‘biomedical, behavioral, and social issues related to alcoholism and alcohol abuse’’ for ‘‘alcohol problems’’; in par. (1)(B) ‘‘facilities (including
laboratory, reference, and data analysis facilities) to
carry out the research plan contained in the application’’ for ‘‘laboratory facilities and reference services
(including reference services that will afford access to
scientific alcohol literature)’’; and in par. (1)(E) ‘‘medical and osteopathic, nursing, social work, and other
specialized graduate students; and’’ for ‘‘medical and
osteopathic students and physicians;’’, and added par.
(1)(F).
Subsec. (b). Pub. L. 96–180, § 16(b), increased annual
grant limitation to $1,500,000 from $1,000,000.
Subsec. (c). Pub. L. 96–180, § 16(c), authorized appropriation of $8,000,000 and $9,000,000 for fiscal years ending Sept. 30, 1980, and 1981.
1978—Subsec. (a). Pub. L. 95–622 inserted provision following par. (2) relating to approval of applications
under this subsection by the Secretary in a manner
which results in equitable geographic distribution of
Centers.
EFFECTIVE DATE OF 1992 AMENDMENTS
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
SUBPART 15—NATIONAL INSTITUTE ON DRUG ABUSE

§ 285o. Purpose of Institute
(a) In general
The general purpose of the National Institute
on Drug Abuse (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and
support of biomedical and behavioral research,
health services research, research training, and
health information dissemination with respect
to the prevention of drug abuse and the treatment of drug abusers.
(b) Research program
The research program established under this
subpart shall encompass the social, behavioral,
and biomedical etiology, mental and physical
health consequences, and social and economic
consequences of drug abuse. In carrying out the
program, the Director of the Institute shall give
special consideration to projects relating to
drug abuse among women (particularly with respect to pregnant women).
(c) Collaboration
The Director of the Institute shall collaborate
with the Substance Abuse and Mental Health
Services Administration in focusing the services

Page 585

TITLE 42—THE PUBLIC HEALTH AND WELFARE

research activities of the Institute and in disseminating the results of such research to
health professionals and the general public.
(July 1, 1944, ch. 373, title IV, § 464L, as added
Pub. L. 102–321, title I, § 123(a), July 10, 1992, 106
Stat. 360; amended Pub. L. 102–352, § 2(a)(3), Aug.
26, 1992, 106 Stat. 938; Pub. L. 109–482, title I,
§ 103(b)(33), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out subsec.
(d) which related to authorization of appropriations
and allocation for health services research.
1992—Subsec. (d)(1). Pub. L. 102–352 inserted ‘‘other
than section 285o–4 of this title,’’ after ‘‘this subpart,’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate
Director for Prevention who shall be responsible
for the full-time coordination and promotion of
the programs in the Institute concerning the
prevention of drug abuse. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their
professional training or expertise are experts in
drug abuse and the prevention of such abuse.
(b) Report
The Associate Director for Prevention shall
prepare for inclusion in the biennial report made
under section 284b 1 of this title a description of
the prevention activities of the Institute, including a description of the staff and resources
allocated to those activities.
(July 1, 1944, ch. 373, title IV, § 464M, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 361.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–2. Drug Abuse Research Centers
(a) Authority
The Director of the Institute may designate
National Drug Abuse Research Centers for the

purpose of interdisciplinary research relating to
drug abuse and other biomedical, behavioral,
and social issues related to drug abuse. No entity may be designated as a Center unless an application therefore has been submitted to, and
approved by, the Secretary. Such an application
shall be submitted in such manner and contain
such information as the Secretary may reasonably require. The Secretary may not approve
such an application unless—
(1) the application contains or is supported
by reasonable assurances that—
(A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social, and related disciplines,
long-term research on drug abuse and to provide coordination of such research among
such disciplines;
(B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis facilities) to carry
out the research plan contained in the application;
(C) the applicant has facilities and personnel to provide training in the prevention and
treatment of drug abuse;
(D) the applicant has the capacity to train
predoctoral and postdoctoral students for
careers in research on drug abuse;
(E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse for undergraduate and
graduate students, and medical and osteopathic, nursing, social work, and other specialized graduate students; and
(F) the applicant has the capacity to conduct programs of continuing education in
such medical, legal, and social service fields
as the Secretary may require.1
(2) the application contains a detailed fiveyear plan for research relating to drug abuse.
(b) Grants
The Director of the Institute shall, under such
conditions as the Secretary may reasonably require, make annual grants to Centers which
have been designated under this section. No
funds provided under a grant under this subsection may be used for the purchase of any land
or the purchase, construction, preservation, or
repair of any building. For the purposes of the
preceding sentence, the term ‘‘construction’’ has
the meaning given that term by section 292a(1) 2
of this title.
(c) Drug abuse and addiction research
(1) Grants or cooperative agreements
The Director of the Institute may make
grants or enter into cooperative agreements to
expand the current and ongoing interdisciplinary research and clinical trials with treatment centers of the National Drug Abuse
Treatment Clinical Trials Network relating to
drug abuse and addiction, including related
biomedical, behavioral, and social issues.
(2) Use of funds
Amounts made available under a grant or
cooperative agreement under paragraph (1) for
1 So

1 See

References in Text note below.

§ 285o–2

in original. The period probably should be ‘‘; and’’.
References in Text note below.

2 See

§ 285o–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

drug abuse and addiction may be used for research and clinical trials relating to—
(A) the effects of drug abuse on the human
body, including the brain;
(B) the addictive nature of drugs and how
such effects differ with respect to different
individuals;
(C) the connection between drug abuse and
mental health;
(D) the identification and evaluation of
the most effective methods of prevention of
drug abuse and addiction;
(E) the identification and development of
the most effective methods of treatment of
drug addiction, including pharmacological
treatments;
(F) risk factors for drug abuse;
(G) effects of drug abuse and addiction on
pregnant women and their fetuses; and
(H) cultural, social, behavioral, neurological, and psychological reasons that individuals abuse drugs, or refrain from abusing
drugs.
(3) Research results
The Director shall promptly disseminate research results under this subsection to Federal, State, and local entities involved in combating drug abuse and addiction.
(July 1, 1944, ch. 373, title IV, § 464N, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 361; amended Pub. L. 102–352, § 2(a)(4), Aug.
26, 1992, 106 Stat. 938; Pub. L. 106–310, div. B, title
XXXVI, § 3631, Oct. 17, 2000, 114 Stat. 1235; Pub.
L. 107–273, div. B, title II, § 2203, Nov. 2, 2002, 116
Stat. 1794; Pub. L. 109–482, title I, § 103(b)(34),
Jan. 15, 2007, 120 Stat. 3688.)
REFERENCES IN TEXT
Section 292a of this title, referred to in subsec. (b),
was in the original a reference to section 701 of act July
1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702,
relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see sections 292o and 295p of this title.
AMENDMENTS
2007—Subsec. (c)(4). Pub. L. 109–482 struck out par. (4)
which authorized appropriations and provided they
were supplemental to other funding of research on drug
abuse.
2002—Subsec. (c). Pub. L. 107–273 amended heading
and text of subsec. (c) generally, substituting provisions relating to grants or cooperative agreements for
research and clinical trials relating to drug abuse and
addiction for similar provisions relating to grants or
cooperative agreements for research and clinical trials
relating to methamphetamine abuse and addiction.
2000—Subsec. (c). Pub. L. 106–310 added subsec. (c).
1992—Subsec. (b). Pub. L. 102–352 substituted ‘‘292a(1)’’
for ‘‘292a(2)’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.

Page 586

102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–3. Office on AIDS
The Director of the Institute shall establish
within the Institute an Office on AIDS. The Office shall be responsible for the coordination of
research and determining the direction of the
Institute with respect to AIDS research related
to—
(1) primary prevention of the spread of HIV,
including transmission via drug abuse;
(2) drug abuse services research; and
(3) other matters determined appropriate by
the Director.
(July 1, 1944, ch. 373, title IV, § 464O, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 362.)
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
STUDY BY NATIONAL ACADEMY OF SCIENCES
Section 706 of Pub. L. 102–321 directed Secretary of
Health and Human Services to contract for a study or
studies relating to programs that provide both sterile
hypodermic needles and bleach to individuals in order
to reduce the risk of contracting acquired immune deficiency syndrome or related conditions, in order to determine extent to which such programs promote the
abuse of drugs or otherwise altered any behaviors constituting a substantial risk of contracting AIDS or
hepatitus, or of transmitting such conditions, and further directed Secretary to ensure that a report is submitted to Congress on the results of this study not
later than 18 months after July 10, 1992.

§ 285o–4. Medication Development Program
(a) Establishment
There is established in the Institute a Medication Development Program through which the
Director of such Institute shall—
(1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate the approval process
of drug abuse treatments;
(2) encourage and promote (through grants,
contracts, international collaboration, or
otherwise) expanded research programs, investigations, experiments, community trials, and
studies, into the development and use of medications to treat drug addiction;
(3) establish or provide for the establishment
of research facilities;
(4) report on the activities of other relevant
agencies relating to the development and use
of pharmacotherapeutic treatments for drug
addiction;
(5) collect, analyze, and disseminate data
useful in the development and use of
pharmacotherapeutic treatments for drug addiction and collect, catalog, analyze, and disseminate through international channels, the
results of such research;

Page 587

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) directly or through grants, contracts, or
cooperative agreements, support training in
the fundamental sciences and clinical disciplines related to the pharmacotherapeutic
treatment of drug abuse, including the use of
training stipends, fellowships, and awards
where appropriate; and
(7) coordinate the activities conducted under
this section with related activities conducted
within the National Institute on Alcohol
Abuse and Alcoholism, the National Institute
of Mental Health, and other appropriate institutes and shall consult with the Directors of
such Institutes.
(b) Duties
In carrying out the activities described in subsection (a) of this section, the Director of the Institute—
(1) shall collect and disseminate through
publications and other appropriate means, information pertaining to the research and
other activities under this section;
(2) shall make grants to or enter into contracts and cooperative agreements with individuals and public and private entities to further the goals of the program;
(3) may, in accordance with section 289e of
this title, and in consultation with the National Advisory Council on Drug Abuse, acquire, construct, improve, repair, operate, and
maintain pharmacotherapeutic research centers, laboratories, and other necessary facilities and equipment, and such other real or personal property as the Director determines necessary, and may, in consultation with such
Advisory Council, make grants for the construction or renovation of facilities to carry
out the purposes of this section;
(4) may accept voluntary and uncompensated services;
(5) may accept gifts, or donations of services, money, or property, real, personal, or
mixed, tangible or intangible; and
(6) shall take necessary action to ensure
that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and
the other scientific, medical, and biomedical
disciplines and organizations nationally and
internationally.
(c) Report
(1) In general
Not later than December 31, 1992, and each
December 31 thereafter, the Director of the Institute shall submit to the Office of National
Drug Control Policy established under section
1501 1 of title 21 a report, in accordance with
paragraph (3), that describes the objectives
and activities of the program assisted under
this section.
(2) National Drug Control Strategy
The Director of National Drug Control Policy shall incorporate, by reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy
submitted the following February 1 under section 1504 1 of title 21.
1 See

References in Text note below.

§ 285o–4

(d) ‘‘Pharmacotherapeutics’’ defined
For purposes of this section, the term
‘‘pharmacotherapeutics’’ means medications
used to treat the symptoms and disease of drug
abuse, including medications to—
(1) block the effects of abused drugs;
(2) reduce the craving for abused drugs;
(3) moderate or eliminate withdrawal symptoms;
(4) block or reverse the toxic effect of abused
drugs; or
(5) prevent relapse in persons who have been
detoxified from drugs of abuse.
(July 1, 1944, ch. 373, title IV, § 464P, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 362; amended Pub. L. 103–43, title XX,
§ 2008(b)(10), June 10, 1993, 107 Stat. 211; Pub. L.
109–482, title I, § 103(b)(35), Jan. 15, 2007, 120 Stat.
3688.)
REFERENCES IN TEXT
Sections 1501 and 1504 of title 21, referred to in subsec.
(c), were repealed by Pub. L. 100–690, title I, § 1009, Nov.
18, 1988, 102 Stat. 4188, as amended.
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated $85,000,000 for fiscal year 1993,
and $95,000,000 for fiscal year 1994.’’
1993—Subsec. (b)(6). Pub. L. 103–43 substituted ‘‘Institute’’ for ‘‘Administration’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
REPORT BY INSTITUTE ON MEDICINE
Section 701 of Pub. L. 102–321 directed Secretary of
Health and Human Services to enter into a contract
with a public or nonprofit private entity to conduct a
study concerning (1) role of the private sector in development of anti-addiction medications, including legislative proposals designed to encourage private sector
development of such medications, (2) process by which
anti-addiction medications receive marketing approval
from Food and Drug Administration, including an assessment of feasibility of expediting marketing approval process in a manner consistent with maintaining safety and effectiveness of such medications, (3)
with respect to pharmacotherapeutic treatments for
drug addiction (A) recommendations with respect to a
national strategy for developing such treatments and
improvements in such strategy, (B) state of the scientific knowledge concerning such treatments, and (C)
assessment of progress toward development of safe, effective pharmacological treatments for drug addiction,
and (4) other related information determined appropriate by the authors of the study, and to submit to
Congress a report of the results of such study not later
than 18 months after July 10, 1992.

§ 285p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

SUBPART 16—NATIONAL INSTITUTE OF MENTAL
HEALTH

§ 285p. Purpose of Institute
(a) In general
The general purpose of the National Institute
of Mental Health (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and
support of biomedical and behavioral research,
health services research, research training, and
health information dissemination with respect
to the cause, diagnosis, treatment, control and
prevention of mental illness.
(b) Research program
The research program established under this
subpart shall include support for biomedical and
behavioral neuroscience and shall be designed to
further the treatment and prevention of mental
illness, the promotion of mental health, and the
study of the psychological, social and legal factors that influence behavior.
(c) Collaboration
The Director of the Institute shall collaborate
with the Administrator of the Substance Abuse
and Mental Health Services Administration in
focusing the services research activities of the
Institute and in disseminating the results of
such research to health professionals and the
general public.
(d) Information with respect to suicide
(1) In general
The Director of the Institute shall—
(A) develop and publish information with
respect to the causes of suicide and the
means of preventing suicide; and
(B) make such information generally
available to the public and to health professionals.
(2) Youth suicide
Information described in paragraph (1) shall
especially relate to suicide among individuals
under 24 years of age.
(e) Associate Director for Special Populations
(1) In general
The Director of the Institute shall designate
an Associate Director for Special Populations.
(2) Duties
The Associate Director for Special Populations shall—
(A) develop and coordinate research policies and programs to assure increased emphasis on the mental health needs of women
and minority populations;
(B) support programs of basic and applied
social and behavioral research on the mental
health problems of women and minority populations;
(C) study the effects of discrimination on
institutions and individuals, including majority institutions and individuals;
(D) support and develop research designed
to eliminate institutional discrimination;
and
(E) provide increased emphasis on the concerns of women and minority populations in
training programs, service delivery pro-

Page 588

grams, and research endeavors of the Institute.
(July 1, 1944, ch. 373, title IV, § 464R, as added
Pub. L. 102–321, title I, § 124(a), July 10, 1992, 106
Stat. 364; amended Pub. L. 102–352, § 2(a)(5), Aug.
26, 1992, 106 Stat. 938; Pub. L. 109–482, title I,
§ 103(b)(36), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (f). Pub. L. 109–482 struck out subsec. (f)
which authorized appropriations and provided that at
least 15% of the appropriated amounts were to carry
out health services research relating to mental health.
1992—Subsec. (f)(1). Pub. L. 102–352 struck out ‘‘other
than section 285o–4 of this title’’ after ‘‘this subpart’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
STUDY OF BARRIERS TO INSURANCE COVERAGE OF
TREATMENT FOR MENTAL ILLNESS AND SUBSTANCE
ABUSE
Section 704 of Pub. L. 102–321 directed Secretary of
Health and Human Services, acting through Director of
the National Institute of Mental Health and in consultation with Administrator of Health Care Financing
Administration, to conduct a study of the barriers to
insurance coverage for the treatment of mental illness
and substance abuse and to submit a report to Congress
on the results of such study not later than Oct. 1, 1993.

§ 285p–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate
Director for Prevention who shall be responsible
for the full-time coordination and promotion of
the programs in the Institute concerning the
prevention of mental disorder. The Associate Director shall be appointed by the Director of the
Institute from individuals who because of their
professional training or expertise are experts in
mental disorder and the prevention of such.
(b) Report
The Associate Director for Prevention shall
prepare for inclusion in the biennial report made
under section 284b 1 of this title a description of
the prevention activities of the Institute, including a description of the staff and resources
allocated to those activities.
(July 1, 1944, ch. 373, title IV, § 464S, as added
Pub. L. 102–321, title I, § 124(b), July 10, 1992, 106
Stat. 365.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
1 See

References in Text note below.

Page 589

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285p–2. Office of Rural Mental Health Research
(a) In general
There is established within the Institute an office to be known as the Office of Rural Mental
Health Research (hereafter in this section referred to as the ‘‘Office’’). The Office shall be
headed by a director, who shall be appointed by
the Director of such Institute from among individuals experienced or knowledgeable in the provision of mental health services in rural areas.
The Secretary shall carry out the authorities established in this section acting through the Director of the Office.
(b) Coordination of activities
The Director of the Office, in consultation
with the Director of the Institute and with the
Director of the Office of Rural Health Policy,
shall—
(1) coordinate the research activities of the
Department of Health and Human Services as
such activities relate to the mental health of
residents of rural areas; and
(2) coordinate the activities of the Office
with similar activities of public and nonprofit
private entities.
(c) Research, demonstrations, evaluations, and
dissemination
The Director of the Office may, with respect
to the mental health of adults and children residing in rural areas—
(1) conduct research on conditions that are
unique to the residents of rural areas, or more
serious or prevalent in such residents;
(2) conduct research on improving the delivery of services in such areas; and
(3) disseminate information to appropriate
public and nonprofit private entities.
(d) Authority regarding grants and contracts
The Director of the Office may carry out the
authorities established in subsection (c) of this
section directly and through grants, cooperative
agreements, or contracts with public or nonprofit private entities.
(July 1, 1944, ch. 373, title IV, § 464T, as added
Pub. L. 102–321, title I, § 124(b), July 10, 1992, 106
Stat. 365; amended Pub. L. 109–482, title I,
§ 104(b)(1)(L), Jan. 15, 2007, 120 Stat. 3693.)
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘Not later
than February 1, 1993, and each fiscal year thereafter,
the Director shall submit to the Subcommittee on
Health and the Environment of the Committee on Energy and Commerce (of the House of Representatives),
and to the Committee on Labor and Human Resources
(of the Senate), a report describing the activities of the
Office during the preceding fiscal year, including a
summary of the activities of demonstration projects
and a summary of evaluations of the projects.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or

§ 285q

subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285p–3. Office on AIDS
The Director of the Institute shall establish
within the Institute an Office on AIDS. The Office shall be responsible for the coordination of
research and determining the direction of the
Institute with respect to AIDS research related
to—
(1) primary prevention of the spread of HIV,
including transmission via sexual behavior;
(2) mental health services research; and
(3) other matters determined appropriate by
the Director.
(July 1, 1944, ch. 373, title IV, § 464U, as added
Pub. L. 102–321, title I, § 124(b), July 10, 1992, 106
Stat. 366.)
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
SUBPART 17—NATIONAL INSTITUTE OF NURSING
RESEARCH

§ 285q. Purpose of Institute
The general purpose of the National Institute
of Nursing Research (in this subpart referred to
as the ‘‘Institute’’) is the conduct and support
of, and dissemination of information respecting,
basic and clinical nursing research, training,
and other programs in patient care research.
(July 1, 1944, ch. 373, title IV, § 464V, formerly
§ 483, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99
Stat. 867; renumbered § 464V and amended Pub.
L. 103–43, title XV, § 1511(a)(1), (b)(2), June 10,
1993, 107 Stat. 178, 179.)
CODIFICATION
Section was formerly classified to section 287c of this
title prior to renumbering by Pub. L. 103–43.
AMENDMENTS
1993—Pub. L. 103–43, § 1511(a)(1) substituted ‘‘Institute’’ for ‘‘Center’’ in section catchline and ‘‘National
Institute of Nursing Research (in this subpart referred
to as the ‘Institute’)’’ for ‘‘National Center for Nursing
Research (hereafter in this subpart referred to as the
‘Center’)’’ in text.
STUDY ON ADEQUACY OF NUMBER OF NURSES
Section 1512 of Pub. L. 103–43 directed Secretary of
Health and Human Services, acting through Director of
National Institute of Nursing Research, to enter into a
contract with a public or nonprofit private entity to
conduct a study for purpose of determining whether
and to what extent there is a need for an increase in
the number of nurses in hospitals and nursing homes in
order to promote the quality of patient care and reduce
the incidence among nurses of work-related injuries
and stress and to complete such study and submit a report to Congress not later than 18 months after June 10,
1993.

§ 285q–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 285q–1. Specific authorities
To carry out section 285q of this title, the Director of the Institute may provide research
training and instruction and establish, in the Institute and other nonprofit institutions, research traineeships and fellowships in the study
and investigation of the prevention of disease,
health promotion, and the nursing care of individuals with and the families of individuals with
acute and chronic illnesses. The Director of the
Institute may provide individuals receiving such
training and instruction or such traineeships or
fellowships with such stipends and allowances
(including amounts for travel and subsistence
and dependency allowances) as the Director determines necessary. The Director may make
grants to nonprofit institutions to provide such
training and instruction and traineeships and
fellowships.
(July 1, 1944, ch. 373, title IV, § 464W, formerly
§ 484, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99
Stat. 867; renumbered § 464W and amended Pub.
L. 103–43, title XV, § 1511(a)(2), (b)(2), (4)(A), June
10, 1993, 107 Stat. 178, 179.)
CODIFICATION
Section was formerly classified to section 287c–1 of
this title prior to renumbering by Pub. L. 103–43.
AMENDMENTS
1993—Pub. L. 103–43, § 1511(a)(2), (b)(4)(A), substituted
‘‘section 285q’’ for ‘‘section 287c’’ and ‘‘Institute’’ for
‘‘Center’’ wherever appearing.

§ 285q–2. Advisory council
(a) Appointment; functions and duties; acceptance of conditional gifts; subcommittees
(1) The Secretary shall appoint an advisory
council for the Institute which shall advise, assist, consult with, and make recommendations
to the Secretary and the Director of the Institute on matters related to the activities carried
out by and through the Institute and the policies respecting such activities.
(2) The advisory council for the Institute may
recommend to the Secretary acceptance, in accordance with section 238 of this title, of conditional gifts for study, investigations, and research and for the acquisition of grounds or construction, equipping, or maintenance of facilities for the Institute.
(3) The advisory council for the Institute—
(A)(i) may make recommendations to the Director of the Institute respecting research
conducted at the Institute,
(ii) may review applications for grants and
cooperative agreements for research or training and recommend for approval applications
for projects which show promise of making
valuable contributions to human knowledge,
and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or
entered into by the Institute;
(B) may collect, by correspondence or by
personal investigation, information as to studies which are being carried on in the United
States or any other country as to the diseases,
disorders, or other aspects of human health
with respect to which the Institute is con-

Page 590

cerned and with the approval of the Director
of the Institute make available such information through appropriate publications for the
benefit of public and private health entities
and health professions personnel and scientists and for the information of the general
public; and
(C) may appoint subcommittees and convene
workshops and conferences.
(b) Membership; ex officio members; compensation
(1) The advisory council shall consist of ex
officio members and not more than eighteen
members appointed by the Secretary.
(2) The ex officio members of the advisory
council shall consist of—
(A) the Secretary, the Director of NIH, the
Director of the Institute, the chief nursing officer of the Department of Veterans Affairs,
the Assistant Secretary of Defense for Health
Affairs, the Director of the Division of Nursing
of the Health Resources and Services Administration (or the designees of such officers), and
(B) such additional officers or employees of
the United States as the Secretary determines
necessary for the advisory council to effectively carry out its functions.
(3) The members of the advisory council who
are not ex officio members shall be appointed as
follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific
disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Institute. Of the members appointed pursuant to this subparagraph, at
least seven shall be professional nurses who
are recognized experts in the area of clinical
practice, education, or research.
(B) One-third of the members shall be appointed by the Secretary from the general
public and shall include leaders in fields of
public policy, law, health policy, economics,
and management.
(4) Members of the advisory council who are
officers or employees of the United States shall
not receive any compensation for service on the
advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the
daily equivalent of the annual rate in effect for
grade GS–18 of the General Schedule.
(c) Term of office; vacancy; reappointment
The term of office of an appointed member of
the advisory council is four years, except that
any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such term and the Secretary shall
make appointments to an advisory council in
such a manner as to ensure that the terms of the
members do not all expire in the same year. A
member may serve after the expiration of the
member’s term until a successor has taken office. A member who has been appointed for a
term of four years may not be reappointed to an
advisory council before two years from the date

Page 591

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of expiration of such term of office. If a vacancy
occurs in the advisory council among the appointed members, the Secretary shall make an
appointment to fill the vacancy within 90 days
from the date the vacancy occurs.
(d) Chairman; selection; term of office
The chairman of the advisory council shall be
selected by the Secretary from among the appointed members, except that the Secretary
may select the Director of the Institute to be
the chairman of the advisory council. The term
of office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of
the chairman or upon the request of the Director of the Institute, but at least three times
each fiscal year. The location of the meetings of
the advisory council is subject to the approval
of the Director of the Institute.
(f) Executive secretary; staff; orientation and
training for new members
The Director of the Institute shall designate a
member of the staff of the Institute to serve as
the executive secretary of the advisory council.
The Director of the Institute shall make available to the advisory council such staff, information, and other assistance as it may require to
carry out its functions. The Director of the Institute shall provide orientation and training
for new members of the advisory council to provide them with such information and training as
may be appropriate for their effective participation in the functions of the advisory council.
(g) Material for inclusion in biennial report; additional reports
The advisory council may prepare, for inclusion in the biennial report made under section
285q–3 of this title, (1) comments respecting the
activities of the advisory council in the fiscal
years respecting which the report is prepared,
(2) comments on the progress of the Institute in
meeting its objectives, and (3) recommendations
respecting the future directions and program
and policy emphasis of the Institute. The advisory council may prepare such additional reports as it may determine appropriate.
(July 1, 1944, ch. 373, title IV, § 464X, formerly
§ 485, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99
Stat. 867; amended Pub. L. 101–381, title I,
§ 102(4), Aug. 18, 1990, 104 Stat. 586; Pub. L. 102–54,
§ 13(q)(1)(E), June 13, 1991, 105 Stat. 279; renumbered § 464X and amended Pub. L. 103–43, title
XV,
§ 1511(a)(3),
(b)(2),
(4)(B),
title
XX,
§§ 2008(b)(13), 2010(b)(5), June 10, 1993, 107 Stat.
178, 179, 211, 214.)
CODIFICATION
Section was formerly classified to section 285c–2 of
this title prior to renumbering by Pub. L. 103–43.
AMENDMENTS
1993—Subsec. (a). Pub. L. 103–43, § 1511(a)(3)(A), substituted ‘‘Institute’’ for ‘‘Center’’ wherever appearing.
Subsec. (a)(2). Pub. L. 103–43, § 2010(b)(5), which directed the substitution of ‘‘section 238’’ for ‘‘section
300aaa’’ in section 287c–2(a)(2) of this title, was executed to subsec. (a)(2) of this section to reflect the
probable intent of Congress and the renumbering of
this section. See Codification note above.

§ 285q–3

Subsec. (b)(2)(A). Pub. L. 103–43, § 2008(b)(13), which directed the substitution of ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’ in section
287c–2(b)(2)(A) of this title could not be executed because the words ‘‘Veterans’ Administration’’ do not appear in subsec. (b)(2)(A) of this section subsequent to
amendment by Pub. L. 102–54 and because of the renumbering of this section. See Codification note above and
1991 Amendment note below.
Pub. L. 103–43, §§ 1511(a)(3)(B)(i), substituted ‘‘Institute’’ for ‘‘Center’’.
Subsec. (b)(3)(A). Pub. L. 103–43, § 1511(a)(3)(B)(ii), substituted ‘‘Institute’’ for ‘‘Center’’.
Subsecs. (d) to (f). Pub. L. 103–43, § 1511(a)(3)(C), substituted ‘‘Institute’’ for ‘‘Center’’ wherever appearing.
Subsec. (g). Pub. L. 103–43, § 1511(a)(3)(C), (b)(4)(B),
substituted ‘‘section 285q–3’’ for ‘‘section 287c–3’’ and
‘‘Institute’’ for ‘‘Center’’ in two places.
1991—Subsec. (b)(2)(A). Pub. L. 102–54 substituted
‘‘chief nursing officer of the Department of Veterans
Affairs’’ for ‘‘Chief Nursing Officer of the Veterans’ Administration’’.
1990—Subsec. (a)(2). Pub. L. 101–381 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by the Congress, its duration is
otherwise provided by law. See sections 3(2) and 14 of
Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in
the Appendix to Title 5, Government Organization and
Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 285q–3. Biennial report
The Director of the Institute after consultation with the advisory council for the Institute,
shall prepare for inclusion in the biennial report
made under section 283 of this title a biennial
report which shall consist of a description of the
activities of the Institute and program policies
of the Director of the Institute in the fiscal
years respecting which the report is prepared.
The Director of the Institute may prepare such
additional reports as the Director determines
appropriate. The Director of the Institute shall
provide the advisory council of the Institute an
opportunity for the submission of the written
comments referred to in section 285q–2(g) of this
title.
(July 1, 1944, ch. 373, title IV, § 464Y, formerly
§ 486, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99
Stat. 869; renumbered § 485A, renumbered § 464Y,

§ 285r

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and amended Pub. L. 103–43, title I, § 141(a)(1),
title XV, § 1511(a)(4), (b)(2), (4)(C), June 10, 1993,
107 Stat. 136, 179.)
CODIFICATION
Section was formerly classified to section 287c–3 of
this title prior to renumbering by Pub. L. 103–43.
AMENDMENTS
1993—Pub. L. 103–43, § 1511(a)(4), (b)(4)(C), substituted
‘‘Institute’’ for ‘‘Center’’ wherever appearing and ‘‘section 285q–2(g)’’ for ‘‘section 287c–2(g)’’.
SUBPART 18—NATIONAL INSTITUTE OF BIOMEDICAL
IMAGING AND BIOENGINEERING

§ 285r. Purpose of the Institute
(a) In general
The general purpose of the National Institute
of Biomedical Imaging and Bioengineering (in
this section referred to as the ‘‘Institute’’) is the
conduct and support of research, training, the
dissemination of health information, and other
programs with respect to biomedical imaging,
biomedical engineering, and associated technologies and modalities with biomedical applications (in this section referred to as ‘‘biomedical imaging and bioengineering’’).
(b) National Biomedical Imaging and Bioengineering Program
(1) The Director of the Institute, with the advice of the Institute’s advisory council, shall establish a National Biomedical Imaging and Bioengineering Program (in this section referred to
as the ‘‘Program’’).
(2) Activities under the Program shall include
the following with respect to biomedical imaging and bioengineering:
(A) Research into the development of new
techniques and devices.
(B) Related research in physics, engineering,
mathematics, computer science, and other disciplines.
(C) Technology assessments and outcomes
studies to evaluate the effectiveness of biologics, materials, processes, devices, procedures, and informatics.
(D) Research in screening for diseases and
disorders.
(E) The advancement of existing imaging
and bioengineering modalities, including imaging, biomaterials, and informatics.
(F) The development of target-specific
agents to enhance images and to identify and
delineate disease.
(G) The development of advanced engineering and imaging technologies and techniques
for research from the molecular and genetic to
the whole organ and body levels.
(H) The development of new techniques and
devices for more effective interventional procedures (such as image-guided interventions).
(3)(A) With respect to the Program, the Director of the Institute shall prepare and transmit
to the Secretary and the Director of NIH a plan
to initiate, expand, intensify, and coordinate activities of the Institute with respect to biomedical imaging and bioengineering. The plan
shall include such comments and recommendations as the Director of the Institute determines

Page 592

appropriate. The Director of the Institute shall
periodically review and revise the plan and shall
transmit any revisions of the plan to the Secretary and the Director of NIH.
(B) The plan under subparagraph (A) shall include the recommendations of the Director of
the Institute with respect to the following:
(i) Where appropriate, the consolidation of
programs of the National Institutes of Health
for the express purpose of enhancing support
of activities regarding basic biomedical imaging and bioengineering research.
(ii) The coordination of the activities of the
Institute with related activities of the other
agencies of the National Institutes of Health
and with related activities of other Federal
agencies.
(c) Membership
The establishment under section 284a of this
title of an advisory council for the Institute is
subject to the following:
(1) The number of members appointed by the
Secretary shall be 12.
(2) Of such members—
(A) six members shall be scientists, engineers, physicians, and other health professionals who represent disciplines in biomedical imaging and bioengineering and who
are not officers or employees of the United
States; and
(B) six members shall be scientists, engineers, physicians, and other health professionals who represent other disciplines and
are knowledgeable about the applications of
biomedical imaging and bioengineering in
medicine, and who are not officers or employees of the United States.
(3) In addition to the ex officio members
specified in section 284a(b)(2) of this title, the
ex officio members of the advisory council
shall include the Director of the Centers for
Disease Control and Prevention, the Director
of the National Science Foundation, and the
Director of the National Institute of Standards and Technology (or the designees of such
officers).
(July 1, 1944, ch. 373, title IV, § 464z, as added
Pub. L. 106–580, § 3(a), Dec. 29, 2000, 114 Stat. 3089;
amended Pub. L. 109–482, title I, § 103(b)(37), Jan.
15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out subsec.
(d) which related to appropriations for fiscal years 2001
to 2003.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE
Pub. L. 106–580, § 4, Dec. 29, 2000, 114 Stat. 3092, provided that: ‘‘This Act [enacting this subpart, amending
section 281 of this title, and enacting provisions set out
as notes under this section and section 201 of this title]
takes effect October 1, 2000, or upon the date of the enactment of this Act [Dec. 29, 2000], whichever occurs
later.’’

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TITLE 42—THE PUBLIC HEALTH AND WELFARE
FINDINGS

Pub. L. 106–580, § 2, Dec. 29, 2000, 114 Stat. 3088, provided that: ‘‘The Congress makes the following findings:
‘‘(1) Basic research in imaging, bioengineering,
computer science, informatics, and related fields is
critical to improving health care but is fundamentally different from the research in molecular biology
on which the current national research institutes at
the National Institutes of Health (‘NIH’) are based.
To ensure the development of new techniques and
technologies for the 21st century, these disciplines
therefore require an identity and research home at
the NIH that is independent of the existing institute
structure.
‘‘(2) Advances based on medical research promise
new, more effective treatments for a wide variety of
diseases, but the development of new, noninvasive
imaging techniques for earlier detection and diagnosis of disease is essential to take full advantage of
such new treatments and to promote the general improvement of health care.
‘‘(3) The development of advanced genetic and molecular imaging techniques is necessary to continue
the current rapid pace of discovery in molecular biology.
‘‘(4) Advances in telemedicine, and teleradiology in
particular, are increasingly important in the delivery
of high quality, reliable medical care to rural citizens
and other underserved populations. To fulfill the
promise of telemedicine and related technologies
fully, a structure is needed at the NIH to support
basic research focused on the acquisition, transmission, processing, and optimal display of images.
‘‘(5) A number of Federal departments and agencies
support imaging and engineering research with potential medical applications, but a central coordinating body, preferably housed at the NIH, is needed
to coordinate these disparate efforts and facilitate
the transfer of technologies with medical applications.
‘‘(6) Several breakthrough imaging technologies,
including magnetic resonance imaging (‘MRI’) and
computed tomography (‘CT’), have been developed
primarily abroad, in large part because of the absence
of a home at the NIH for basic research in imaging
and related fields. The establishment of a central
focus for imaging and bioengineering research at the
NIH would promote both scientific advance and
United States economic development.
‘‘(7) At a time when a consensus exists to add significant resources to the NIH in coming years, it is
appropriate to modernize the structure of the NIH to
ensure that research dollars are expended more effectively and efficiently and that the fields of medical
science that have contributed the most to the detection, diagnosis, and treatment of disease in recent
years receive appropriate emphasis.
‘‘(8) The establishment of a National Institute of
Biomedical Imaging and Bioengineering at the NIH
would accelerate the development of new technologies with clinical and research applications, improve coordination and efficiency at the NIH and
throughout the Federal Government, reduce duplication and waste, lay the foundation for a new medical
information age, promote economic development, and
provide a structure to train the young researchers
who will make the pathbreaking discoveries of the
next century.’’
ESTABLISHMENT OF INSTITUTE AND ADVISORY COUNCIL
Pub. L. 106–580, § 3(b)–(d), Dec. 29, 2000, 114 Stat. 3091,
provided that:
‘‘(b) USE OF EXISTING RESOURCES.—In providing for
the establishment of the National Institute of Biomedical Imaging and Bioengineering pursuant to the
amendment made by subsection (a) [enacting this subpart], the Director of the National Institutes of Health
(referred to in this subsection as ‘NIH’)—

§ 285s

‘‘(1) may transfer to the National Institute of Biomedical Imaging and Bioengineering such personnel
of NIH as the Director determines to be appropriate;
‘‘(2) may, for quarters for such Institute, utilize
such facilities of NIH as the Director determines to
be appropriate; and
‘‘(3) may obtain administrative support for the Institute from the other agencies of NIH, including the
other national research institutes.
‘‘(c) CONSTRUCTION OF FACILITIES.—None of the provisions of this Act [enacting this subpart, amending section 281 of this title, and enacting provisions set out as
notes under this section and section 201 of this title] or
the amendments made by the Act may be construed as
authorizing the construction of facilities, or the acquisition of land, for purposes of the establishment or operation of the National Institute of Biomedical Imaging and Bioengineering.
‘‘(d) DATE CERTAIN FOR ESTABLISHMENT OF ADVISORY
COUNCIL.—Not later than 90 days after the effective
date of this Act [Dec. 29, 2000] under section 4 [set out
above], the Secretary of Health and Human Services
shall complete the establishment of an advisory council for the National Institute of Biomedical Imaging
and Bioengineering in accordance with section 406 of
the Public Health Service Act [section 284a of this
title] and in accordance with section 464z of such Act
(as added by subsection (a) of this section) [this section].’’
SUBPART 19—NATIONAL HUMAN GENOME RESEARCH
INSTITUTE

AMENDMENTS
2007—Pub. L. 109–482, title I, § 101(c)(1)–(3), Jan. 15,
2007, 120 Stat. 3681, redesignated subpart 3 of part E of
this subchapter as this subpart.

§ 285s. Purpose of Institute
(a) General purpose
The general purpose of the National Human
Genome Research Institute (in this subpart referred to as the ‘‘Institute’’) is to characterize
the structure and function of the human genome, including the mapping and sequencing of
individual genes. Such purpose includes—
(1) planning and coordinating the research
goal of the genome project;
(2) reviewing and funding research proposals;
(3) developing training programs;
(4) coordinating international genome research;
(5) communicating advances in genome
science to the public; and
(6) reviewing and funding proposals to address the ethical and legal issues associated
with the genome project (including legal issues regarding patents).
(b) Research training
The Director of the Institute may conduct and
support research training—
(1) for which fellowship support is not provided under section 288 of this title; and
(2) that is not residency training of physicians or other health professionals.
(c) Amount available for ethical and legal issues
(1) Except as provided in paragraph (2), of the
amounts appropriated to carry out subsection
(a) of this section for a fiscal year, the Director
of the Institute shall make available not less
than 5 percent for carrying out paragraph (6) of
such subsection.
(2) With respect to providing funds under subsection (a)(6) of this section for proposals to ad-

§ 285t

TITLE 42—THE PUBLIC HEALTH AND WELFARE

dress the ethical issues associated with the genome project, paragraph (1) shall not apply for a
fiscal year if the Director of the Institute certifies to the Committee on Energy and Commerce of the House of Representatives, and to
the Committee on Labor and Human Resources
of the Senate, that the Director has determined
that an insufficient number of such proposals
meet the applicable requirements of sections 289
and 289a of this title.
(July 1, 1944, ch. 373, title IV, § 464z–1, formerly
§ 485B, as added Pub. L. 103–43, title XV, § 1521(2),
June 10, 1993, 107 Stat. 180; renumbered § 464z–1
and amended Pub. L. 109–482, title I, § 101(c)(4),
Jan. 15, 2007, 120 Stat. 3681.)
CODIFICATION
Section was formerly classified to section 287c of this
title prior to renumbering by Pub. L. 109–482.
AMENDMENTS
2007—Pub. L. 109–482, § 101(c)(4)(C), substituted ‘‘Institute’’ for ‘‘Center’’ wherever appearing in section
catchline and text.
Subsec. (a). Pub. L. 109–482, § 101(c)(4)(B), substituted
‘‘National Human Genome Research Institute’’ for ‘‘National Center for Human Genome Research’’ in introductory provisions.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 20—NATIONAL INSTITUTE ON MINORITY
HEALTH AND HEALTH DISPARITIES

AMENDMENTS
2010—Pub. L. 111–148, title X, § 10334(c)(1)(A)–(C),
(D)(ii), Mar. 23, 2010, 124 Stat. 973, redesignated subpart
6 of part E of this subchapter as this subpart and substituted ‘‘National Institute on Minority Health and
Health Disparities’’ for ‘‘National Center on Minority
Health and Health Disparities’’ in heading.

§ 285t. Purpose of Institute
(a) In general
The general purpose of the National Institute
on Minority Health and Health Disparities (in
this subpart referred to as the ‘‘Institute’’) is
the conduct and support of research, training,
dissemination of information, and other programs with respect to minority health conditions and other populations with health disparities.

Page 594

(b) Priorities
The Director of the Institute shall in expending amounts appropriated under this subpart
give priority to conducting and supporting minority health disparities research.
(c) Minority health disparities research
For purposes of this subpart:
(1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral
research on minority health conditions (as defined in paragraph (2)), including research to
prevent, diagnose, and treat such conditions.
(2) The term ‘‘minority health conditions’’,
with respect to individuals who are members
of minority groups, means all diseases, disorders, and conditions (including with respect
to mental health and substance abuse)—
(A) unique to, more serious, or more prevalent in such individuals;
(B) for which the factors of medical risk or
types of medical intervention may be different for such individuals, or for which it is
unknown whether such factors or types are
different for such individuals; or
(C) with respect to which there has been
insufficient research involving such individuals as subjects or insufficient data on such
individuals.
(3) The term ‘‘minority group’’ has the
meaning given the term ‘‘racial and ethnic minority group’’ in section 300u–6 of this title.
(4) The terms ‘‘minority’’ and ‘‘minorities’’
refer to individuals from a minority group.
(d) Health disparity populations
For purposes of this subpart:
(1) A population is a health disparity population if, as determined by the Director of the
Institute after consultation with the Director
of the Agency for Healthcare Research and
Quality, there is a significant disparity in the
overall rate of disease incidence, prevalence,
morbidity, mortality, or survival rates in the
population as compared to the health status of
the general population.
(2) The Director shall give priority consideration to determining whether minority groups
qualify as health disparity populations under
paragraph (1).
(3) The term ‘‘health disparities research’’
means basic, clinical, and behavioral research
on health disparity populations (including individual members and communities of such
populations) that relates to health disparities
as defined under paragraph (1), including the
causes of such disparities and methods to prevent, diagnose, and treat such disparities.
(e) Coordination of activities
The Director of the Institute shall act as the
primary Federal official with responsibility for
coordinating all minority health disparities research and other health disparities research conducted or supported by the National Institutes
of Health, and—
(1) shall represent the health disparities research program of the National Institutes of
Health, including the minority health disparities research program, at all relevant Executive branch task forces, committees and planning activities; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) shall maintain communications with all
relevant Public Health Service agencies, including the Indian Health Service, and various
other departments of the Federal Government
to ensure the timely transmission of information concerning advances in minority health
disparities research and other health disparities research between these various agencies
for dissemination to affected communities and
health care providers.
(f) Collaborative comprehensive plan and budget
(1) In general
Subject to the provisions of this section and
other applicable law, the Director of NIH, the
Director of the Institute, and the directors of
the other agencies of the National Institutes
of Health in collaboration (and in consultation
with the advisory council for the Institute)
shall—
(A) establish a comprehensive plan and
budget for the conduct and support of all minority health disparities research and other
health disparities research activities of the
agencies of the National Institutes of Health
(which plan and budget shall be first established under this subsection not later than
12 months after November 22, 2000);
(B) ensure that the plan and budget establish priorities among the health disparities
research activities that such agencies are
authorized to carry out;
(C) ensure that the plan and budget establish objectives regarding such activities, describes the means for achieving the objectives, and designates the date by which the
objectives are expected to be achieved;
(D) ensure that, with respect to amounts
appropriated for activities of the Institute,
the plan and budget give priority in the expenditure of funds to conducting and supporting minority health disparities research;
(E) ensure that all amounts appropriated
for such activities are expended in accordance with the plan and budget;
(F) review the plan and budget not less
than annually, and revise the plan and budget as appropriate;
(G) ensure that the plan and budget serve
as a broad, binding statement of policies regarding minority health disparities research
and other health disparities research activities of the agencies, but do not remove the
responsibility of the heads of the agencies
for the approval of specific programs or
projects, or for other details of the daily administration of such activities, in accordance with the plan and budget; and
(H) promote coordination and collaboration among the agencies conducting or supporting minority health or other health disparities research.
(2) Certain components of plan and budget
With respect to health disparities research
activities of the agencies of the National Institutes of Health, the Director of the Institute
shall ensure that the plan and budget under
paragraph (1) provide for—
(A) basic research and applied research, including research and development with respect to products;

§ 285t

(B) research that is conducted by the agencies;
(C) research that is supported by the agencies;
(D) proposals developed pursuant to solicitations by the agencies and for proposals developed independently of such solicitations;
and
(E) behavioral research and social sciences
research, which may include cultural and
linguistic research in each of the agencies.
(3) Minority health disparities research
The plan and budget under paragraph (1)
shall include a separate statement of the plan
and budget for minority health disparities research.
(g) Participation in clinical research
The Director of the Institute shall work with
the Director of NIH and the directors of the
agencies of the National Institutes of Health to
carry out the provisions of section 289a–2 of this
title that relate to minority groups.
(h) 1 Research endowments
(1) In general
The Director of the Institute may carry out
a program to facilitate minority health disparities research and other health disparities
research by providing for research endowments—
(1) 2 at centers of excellence under section
293 of this title; and
(2) 3 at centers of excellence under section
285t–1 of this title.
(2) Eligibility
The Director of the Institute may provide
for a research endowment under paragraph (1)
only if the institution involved meets the following conditions:
(A) The institution does not have an endowment that is worth in excess of an
amount equal to 50 percent of the national
median of endowment funds at institutions
that conduct similar biomedical research or
training of health professionals.
(B) The application of the institution
under paragraph (1) regarding a research endowment has been recommended pursuant to
technical and scientific peer review and has
been approved by the advisory council under
subsection (j) of this section.
(i) Certain activities
In carrying out subsection (a) of this section,
the Director of the Institute—
(1) shall assist the Director of the National
Institute 4 for Research Resources in carrying
out section 287a–1(c)(3) 5 of this title and in
committing resources for construction at Institutions of Emerging Excellence;
(2) shall establish projects to promote cooperation among Federal agencies, State,
local, tribal, and regional public health agen1 Another

subsec. (h) is set out after subsec. (j).
in original. Probably should be ‘‘(A)’’.
3 So in original. Probably should be ‘‘(B)’’.
4 So in original. Probably should be ‘‘Center’’.
5 So in original. Section 287a–1 of this title does not contain
subsections.
2 So

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

cies, and private entities in health disparities
research; and
(3) may utilize information from previous
health initiatives concerning minorities and
other health disparity populations.
(j) Advisory council
(1) In general
The Secretary shall, in accordance with section 284a of this title, establish an advisory
council to advise, assist, consult with, and
make recommendations to the Director of the
Institute on matters relating to the activities
described in subsection (a) of this section, and
with respect to such activities to carry out
any other functions described in section 284a
of this title for advisory councils under such
section. Functions under the preceding sentence shall include making recommendations
on budgetary allocations made in the plan
under subsection (f) of this section, and shall
include reviewing reports under subsection (k)
of this section before the reports are submitted under such subsection.
(2) Membership
With respect to the membership of the advisory council under paragraph (1), a majority of
the members shall be individuals with demonstrated expertise regarding minority health
disparity and other health disparity issues;
representatives of communities impacted by
minority and other health disparities shall be
included; and a diversity of health professionals shall be represented. The membership
shall in addition include a representative of
the Office of Behavioral and Social Sciences
Research under section 283c of this title.
(h) 6 Interagency coordination
The Director of the Institute, as the primary
Federal officials 7 with responsibility for coordinating all research and activities conducted or
supported by the National Institutes of Health
on minority health and health disparities, shall
plan, coordinate, review and evaluate research
and other activities conducted or supported by
the Institutes and Centers of the National Institutes of Health.
(July 1, 1944, ch. 373, title IV, § 464z–3, formerly
§ 485E, as added Pub. L. 106–525, title I, § 101(a),
Nov. 22, 2000, 114 Stat. 2497; amended Pub. L.
109–482, title I, §§ 103(b)(44), 104(b)(1)(N), Jan. 15,
2007, 120 Stat. 3688, 3693; renumbered § 464z–3 and
amended Pub. L. 111–148, title X, § 10334(c)(1)(D),
(2), Mar. 23, 2010, 124 Stat. 973.)
CODIFICATION
Section was formerly classified to section 287c–31 of
this title prior to renumbering by Pub. L. 111–148.

Page 596

Subsecs.
(b),
(d)
to
(g).
Pub.
L.
111–148,
§ 10334(c)(1)(D)(iii), substituted ‘‘Institute’’ for ‘‘Center’’
wherever appearing.
Subsec. (h). Pub. L. 111–148, § 10334(c)(2)(C), added at
end subsec. (h) relating to interagency coordination.
Subsec. (h)(1). Pub. L. 111–148, § 10334(c)(2)(A), in par.
(1) of subsec. (h) relating to research endowments, substituted ‘‘research endowments—
‘‘(1) at centers of excellence under section 293 of
this title; and
‘‘(2) at centers of excellence under section 285t–1 of
this title.’’
for ‘‘research endowments at centers of excellence
under section 293 of this title.’’
Pub. L. 111–148, § 10334(c)(1)(D)(iii), in par. (1) of subsec. (h) relating to research endowments, substituted
‘‘Institute’’ for ‘‘Center’’.
Subsec. (h)(2). Pub. L. 111–148, § 10334(c)(1)(D)(iii), in
par. (2) of subsec. (h) relating to research endowments,
substituted ‘‘Institute’’ for ‘‘Center’’ in introductory
provisions.
Subsec. (h)(2)(A). Pub. L. 111–148, § 10334(c)(2)(B), in
par. (2)(A) of subsec. (h) relating to research endowments, substituted ‘‘median’’ for ‘‘average’’.
Subsecs. (i), (j). Pub. L. 111–148, § 10334(c)(1)(D)(iii),
substituted ‘‘Institute’’ for ‘‘Center’’ wherever appearing.
2007—Subsec. (k). Pub. L. 109–482, § 104(b)(1)(N), struck
out heading and text of subsec. (k). Text read as follows: ‘‘The Director of the Center shall prepare an annual report on the activities carried out or to be carried out by the Center, and shall submit each such report to the Committee on Health, Education, Labor,
and Pensions of the Senate, the Committee on Commerce of the House of Representatives, the Secretary,
and the Director of NIH. With respect to the fiscal year
involved, the report shall—
‘‘(1) describe and evaluate the progress made in
health disparities research conducted or supported by
the national research institutes;
‘‘(2) summarize and analyze expenditures made for
activities with respect to health disparities research
conducted or supported by the National Institutes of
Health;
‘‘(3) include a separate statement applying the requirements of paragraphs (1) and (2) specifically to
minority health disparities research; and
‘‘(4) contain such recommendations as the Director
considers appropriate.’’
Subsec. (l). Pub. L. 109–482, § 103(b)(44), struck out
heading and text of subsec. (l). Text read as follows:
‘‘For the purpose of carrying out this subpart, there are
authorized to be appropriated $100,000,000 for fiscal year
2001, and such sums as may be necessary for each of the
fiscal years 2002 through 2005. Such authorization of appropriations is in addition to other authorizations of
appropriations that are available for the conduct and
support of minority health disparities research or other
health disparities research by the agencies of the National Institutes of Health.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

AMENDMENTS

FINDINGS

2010—Pub. L. 111–148, § 10334(c)(1)(D)(iii), substituted
‘‘Institute’’ for ‘‘Center’’ in section catchline.
Subsec. (a). Pub. L. 111–148, § 10334(c)(1)(D)(ii), (iii),
substituted ‘‘National Institute on Minority Health and
Health Disparities’’ for ‘‘National Center on Minority
Health and Health Disparities’’ and ‘‘Institute’’ for
‘‘Center’’.

Pub. L. 106–525, § 2, Nov. 22, 2000, 114 Stat. 2495, provided that: ‘‘The Congress finds as follows:
‘‘(1) Despite notable progress in the overall health
of the Nation, there are continuing disparities in the
burden of illness and death experienced by African
Americans, Hispanics, Native Americans, Alaska Natives, and Asian Pacific Islanders, compared to the
United States population as a whole.
‘‘(2) The largest numbers of the medically underserved are white individuals, and many of them have
the same health care access problems as do members

6 So

in original. Another subsec. (h) is set out preceding subsec.

(i).
7 So

in original.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

of minority groups. Nearly 20,000,000 white individuals live below the poverty line with many living in
nonmetropolitan, rural areas such as Appalachia,
where the high percentage of counties designated as
health professional shortage areas (47 percent) and
the high rate of poverty contribute to disparity outcomes. However, there is a higher proportion of racial
and ethnic minorities in the United States represented among the medically underserved.
‘‘(3) There is a national need for minority scientists
in the fields of biomedical, clinical, behavioral, and
health services research. Ninety percent of minority
physicians educated at Historically Black Medical
Colleges live and serve in minority communities.
‘‘(4) Demographic trends inspire concern about the
Nation’s ability to meet its future scientific, technological, and engineering workforce needs. Historically, non-Hispanic white males have made up the
majority of the United States scientific, technological, and engineering workers.
‘‘(5) The Hispanic and Black population will increase significantly in the next 50 years. The scientific, technological, and engineering workforce
may decrease if participation by underrepresented
minorities remains the same.
‘‘(6) Increasing rates of Black and Hispanic workers
can help ensure a strong scientific, technological, and
engineering workforce.
‘‘(7) Individuals such as underrepresented minorities and women in the scientific, technological, and
engineering workforce enable society to address its
diverse needs.
‘‘(8) If there had not been a substantial increase in
the number of science and engineering degrees awarded to women and underrepresented minorities over
the past few decades, the United States would be facing even greater shortages in scientific, technological, and engineering workers.
‘‘(9) In order to effectively promote a diverse and
strong 21st century scientific, technological, and engineering workforce, Federal agencies should expand
or add programs that effectively overcome barriers
such as educational transition from one level to the
next and student requirements for financial resources.
‘‘(10) Federal agencies should work in concert with
the private nonprofit sector to emphasize the recruitment and retention of qualified individuals from ethnic and gender groups that are currently underrepresented in the scientific, technological, and engineering workforce.
‘‘(11) Behavioral and social sciences research has increased awareness and understanding of factors associated with health care utilization and access, patient attitudes toward health services, and risk and
protective behaviors that affect health and illness.
These factors have the potential to then be modified
to help close the health disparities gap among ethnic
minority populations. In addition, there is a shortage
of minority behavioral science researchers and behavioral health care professionals. According to the National Science Foundation, only 15.5 percent of behavioral research-oriented psychology doctorate degrees were awarded to minority students in 1997. In
addition, only 17.9 percent of practice-oriented psychology doctorate degrees were awarded to ethnic minorities.’’
PUBLIC AWARENESS AND DISSEMINATION OF
INFORMATION ON HEALTH DISPARITIES
Pub. L. 106–525, title V, § 501, Nov. 22, 2000, 114 Stat.
2510, provided that:
‘‘(a) PUBLIC AWARENESS ON HEALTH DISPARITIES.—The
Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct a national campaign to inform the public and health care
professionals about health disparities in minority and
other underserved populations by disseminating information and materials available on specific diseases affecting these populations and programs and activities
to address these disparities. The campaign shall—

§ 285t–1

‘‘(1) have a specific focus on minority and other underserved communities with health disparities; and
‘‘(2) include an evaluation component to assess the
impact of the national campaign in raising awareness
of health disparities and information on available resources.
‘‘(b) DISSEMINATION OF INFORMATION ON HEALTH DISPARITIES.—The Secretary shall develop and implement
a plan for the dissemination of information and findings with respect to health disparities under titles I, II,
III, and IV of this Act [see Tables for classification].
The plan shall—
‘‘(1) include the participation of all agencies of the
Department of Health and Human Services that are
responsible for serving populations included in the
health disparities research; and
‘‘(2) have agency-specific strategies for disseminating relevant findings and information on health disparities and improving health care services to affected communities.’’
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 285t–1. Centers of excellence for research education and training
(a) In general
The Director of the Institute shall make
awards of grants or contracts to designated biomedical and behavioral research institutions
under paragraph (1) of subsection (c) of this section, or to consortia under paragraph (2) of such
subsection, for the purpose of assisting the institutions in supporting programs of excellence in
biomedical and behavioral research training for
individuals who are members of minority health
disparity populations or other health disparity
populations.
(b) Required use of funds
An award may be made under subsection (a) of
this section only if the applicant involved agrees
that the grant will be expended—
(1) to train members of minority health disparity populations or other health disparity
populations as professionals in the area of biomedical or behavioral research or both; or
(2) to expand, remodel, renovate, or alter existing research facilities or construct new research facilities for the purpose of conducting
minority health disparities research and other
health disparities research.
(c) Centers of excellence
(1) In general
For purposes of this section, a designated
biomedical and behavioral research institution
is a biomedical and behavioral research institution that—

§ 285t–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) has a significant number of members of
minority health disparity populations or
other health disparity populations enrolled
as students in the institution (including individuals accepted for enrollment in the institution);
(B) has been effective in assisting such students of the institution to complete the program of education or training and receive
the degree involved;
(C) has made significant efforts to recruit
minority students to enroll in and graduate
from the institution, which may include providing means-tested scholarships and other
financial assistance as appropriate; and
(D) has made significant recruitment efforts to increase the number of minority or
other members of health disparity populations serving in faculty or administrative
positions at the institution.
(2) Consortium
Any designated biomedical and behavioral
research institution involved may, with other
biomedical and behavioral institutions (designated or otherwise), including tribal health
programs, form a consortium to receive an
award under subsection (a) of this section.
(3) Application of criteria to other programs
In the case of any criteria established by the
Director of the Institute for purposes of determining whether institutions meet the conditions described in paragraph (1), this section
may not, with respect to minority health disparity populations or other health disparity
populations, be construed to authorize, require, or prohibit the use of such criteria in
any program other than the program established in this section.
(d) Duration of grant
The period during which payments are made
under a grant under subsection (a) of this section may not exceed 5 years. Such payments
shall be subject to annual approval by the Director of the Institute and to the availability of appropriations for the fiscal year involved to make
the payments.
(e) Maintenance of effort
(1) In general
With respect to activities for which an
award under subsection (a) of this section is
authorized to be expended, the Director of the
Institute may not make such an award to a
designated research institution or consortium
for any fiscal year unless the institution, or
institutions in the consortium, as the case
may be, agree to maintain expenditures of
non-Federal amounts for such activities at a
level that is not less than the level of such expenditures maintained by the institutions involved for the fiscal year preceding the fiscal
year for which such institutions receive such
an award.
(2) Use of Federal funds
With respect to any Federal amounts received by a designated research institution or
consortium and available for carrying out activities for which an award under subsection

Page 598

(a) of this section is authorized to be expended, the Director of the Institute may
make such an award only if the institutions
involved agree that the institutions will, before expending the award, expend the Federal
amounts obtained from sources other than the
award.
(f) Certain expenditures
The Director of the Institute may authorize a
designated biomedical and behavioral research
institution to expend a portion of an award
under subsection (a) of this section for research
endowments.
(g) Definitions
For purposes of this section:
(1) The term ‘‘designated biomedical and behavioral research institution’’ has the meaning indicated for such term in subsection (c)(1)
of this section. Such term includes any health
professions school receiving an award of a
grant or contract under section 293 of this
title.
(2) The term ‘‘program of excellence’’ means
any program carried out by a designated biomedical and behavioral research institution
with an award under subsection (a) of this section, if the program is for purposes for which
the institution involved is authorized in subsection (b) of this section to expend the grant.
(July 1, 1944, ch. 373, title IV, § 464z–4, formerly
§ 485F, as added Pub. L. 106–525, title I, § 102, Nov.
22, 2000, 114 Stat. 2501; amended Pub. L. 109–482,
title I, § 103(b)(45), Jan. 15, 2007, 120 Stat. 3688; renumbered § 464z–4 and amended Pub. L. 111–148,
title X, § 10334(c)(1)(D)(i), (iii), Mar. 23, 2010, 124
Stat. 973.)
CODIFICATION
Section was formerly classified to section 287c–32 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Subsecs. (a), (c)(3) to (f). Pub. L. 111–148,
§ 10334(c)(1)(D)(iii), substituted ‘‘Institute’’ for ‘‘Center’’
wherever appearing.
2007—Subsec. (h). Pub. L. 109–482 struck out heading
and text of subsec. (h). Text read as follows: ‘‘For the
purpose of making grants under subsection (a) of this
section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
2001 through 2005.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285t–2. Loan repayment program for minority
health disparities research
(a) In general
The Director of the Institute shall establish a
program of entering into contracts with qualified health professionals under which such
health professionals agree to engage in minority
health disparities research or other health disparities research in consideration of the Federal
Government agreeing to repay, for each year of
engaging in such research, not more than $35,000
of the principal and interest of the educational
loans of such health professionals.

Page 599

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Service provisions
The provisions of sections 254l–1, 254m, and
254o of this title shall, except as inconsistent
with subsection (a) of this section, apply to the
program established in such subsection to the
same extent and in the same manner as such
provisions apply to the National Health Service
Corps Loan Repayment Program established in
subpart III of part D of subchapter II of this
chapter.
(c) Requirement regarding health disparity populations
The Director of the Institute shall ensure that
not fewer than 50 percent of the contracts entered into under subsection (a) of this section
are for appropriately qualified health professionals who are members of a health disparity
population.
(d) Priority
With respect to minority health disparities research and other health disparities research
under subsection (a) of this section, the Secretary shall ensure that priority is given to conducting projects of biomedical research.
(July 1, 1944, ch. 373, title IV, § 464z–5, formerly
§ 485G, as added Pub. L. 106–525, title I, § 103, Nov.
22, 2000, 114 Stat. 2503; amended Pub. L. 109–482,
title I, § 103(b)(46), Jan. 15, 2007, 120 Stat. 3688; renumbered § 464z–5 and amended Pub. L. 111–148,
title X, § 10334(c)(1)(D)(i), (iii), Mar. 23, 2010, 124
Stat. 973.)
CODIFICATION
Section was formerly classified to section 287c–33 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Subsecs.
(a),
(c).
Pub.
L.
111–148,
§ 10334(c)(1)(D)(iii), substituted ‘‘Institute’’ for ‘‘Center’’.
2007—Subsec. (e). Pub. L. 109–482 struck out subsec.
(e) which related to authorization and availability of
appropriations.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 285t–3. General provisions regarding the Institute
The Secretary, acting through the Director of
the National Institutes of Health, shall provide
administrative support and support services to
the Director of the Institute and shall ensure
that such support takes maximum advantage of
existing administrative structures at the agencies of the National Institutes of Health.
(July 1, 1944, ch. 373, title IV, § 464z–6, formerly
§ 485H, as added Pub. L. 106–525, title I, § 104, Nov.
22, 2000, 114 Stat. 2503; amended Pub. L. 109–482,
title I, § 104(b)(1)(O), Jan. 15, 2007, 120 Stat. 3693;
renumbered § 464z–6 and amended Pub. L. 111–148,
title X, § 10334(c)(1)(D)(i), (iii), Mar. 23, 2010, 124
Stat. 973.)
CODIFICATION
Section was formerly classified to section 287c–34 of
this title prior to renumbering by Pub. L. 111–148.

§ 286

AMENDMENTS
2010—Pub. L. 111–148, § 10334(c)(1)(D)(iii), substituted
‘‘Institute’’ for ‘‘Center’’ in section catchline and text.
2007—Pub. L. 109–482 struck out subsec. (a) designation and heading before ‘‘The Secretary’’ and struck
out subsec. (b) which related to evaluation of this subpart not later than 5 years after Nov. 22, 2000, and report on such evaluation not later than 1 year after its
commencement.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

PART D—NATIONAL LIBRARY OF MEDICINE
SUBPART 1—GENERAL PROVISIONS

§ 286. National Library of Medicine
(a) Purpose and establishment
In order to assist the advancement of medical
and related sciences and to aid the dissemination and exchange of scientific and other information important to the progress of medicine
and to the public health, there is established the
National Library of Medicine (hereafter in this
part referred to as the ‘‘Library’’).
(b) Functions
The Secretary, through the Library and subject to subsection (d) of this section, shall—
(1) acquire and preserve books, periodicals,
prints, films, recordings, and other library materials pertinent to medicine;
(2) organize the materials specified in paragraph (1) by appropriate cataloging, indexing,
and bibliographical listings;
(3) publish and disseminate the catalogs, indexes, and bibliographies referred to in paragraph (2);
(4) make available, through loans, photographic or other copying procedures, or otherwise, such materials in the Library as the Secretary determines appropriate;
(5) provide reference and research assistance;
(6) publicize the availability from the Library of the products and services described in
any of paragraphs (1) through (5);
(7) promote the use of computers and telecommunications by health professionals (including health professionals in rural areas) for
the purpose of improving access to biomedical
information for health care delivery and medical research; and
(8) engage in such other activities as the
Secretary determines appropriate and as the
Library’s resources permit.
(c) Exchange, destruction, or disposal of materials not needed
The Secretary may exchange, destroy, or
otherwise dispose of any books, periodicals,
films, and other library materials not needed for
the permanent use of the Library.
(d) Availability of publications, materials, facilities, or services; prescription of rules
(1) The Secretary may, after obtaining the advice and recommendations of the Board of Regents, prescribe rules under which the Library
will—

§ 286a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) provide copies of its publications or materials,
(B) will make available its facilities for research, or
(C) will make available its bibliographic, reference, or other services,
to public and private entities and individuals.
(2) Rules prescribed under paragraph (1) may
provide for making available such publications,
materials, facilities, or services—
(A) without charge as a public service,
(B) upon a loan, exchange, or charge basis,
or
(C) in appropriate circumstances, under contract arrangements made with a public or
other nonprofit entity.
(e) Regional medical libraries; establishment
Whenever the Secretary, with the advice of
the Board of Regents, determines that—
(1) in any geographic area of the United
States there is no regional medical library
adequate to serve such area;
(2) under criteria prescribed for the administration of section 286b–6 of this title, there is
a need for a regional medical library to serve
such area; and
(3) because there is no medical library located in such area which, with financial assistance under section 286b–6 of this title, can
feasibly be developed into a regional medical
library adequate to serve such area,
the Secretary may establish, as a branch of the
Library, a regional medical library to serve the
needs of such area.
(f) Acceptance and administration of gifts; memorials
Section 238 of this title shall be applicable to
the acceptance and administration of gifts made
for the benefit of the Library or for carrying out
any of its functions, and the Board of Regents
shall make recommendations to the Secretary
relating to establishment within the Library of
suitable memorials to the donors.
(g) ‘‘Medicine’’ and ‘‘medical’’ defined
For purposes of this part, the terms ‘‘medicine’’ and ‘‘medical’’, except when used in section 286a of this title, include preventive and
therapeutic medicine, dentistry, pharmacy, hospitalization, nursing, public health, and the fundamental sciences related thereto, and other related fields of study, research, or activity.
(July 1, 1944, ch. 373, title IV, § 465, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended
Pub. L. 99–660, title III, § 311(b)(1), Nov. 14, 1986,
100 Stat. 3779; Pub. L. 100–202, § 101(h) [title II,
§ 215], Dec. 22, 1987, 101 Stat. 1329–256, 1329–275;
Pub. L. 100–607, title II, § 204(2), Nov. 4, 1988, 102
Stat. 3079; Pub. L. 100–690, title II, § 2620(b)(1),
Nov. 18, 1988, 102 Stat. 4244; Pub. L. 101–381, title
I, § 102(2), Aug. 18, 1990, 104 Stat. 585; Pub. L.
103–43, title XIV, § 1401(a), (c)(1), title XX,
§ 2010(b)(3), June 10, 1993, 107 Stat. 170, 214.)
AMENDMENTS
1993—Pub. L. 103–43, § 1401(c)(1), repealed amendment
by Pub. L. 100–202. See 1987 Amendment note below.
Subsec. (b)(6) to (8). Pub. L. 103–43, § 1401(a), added
pars. (6) and (7) and redesignated former par. (6) as (8).

Page 600

Subsec. (f). Pub. L. 103–43, § 2010(b)(3), substituted
‘‘Section 238’’ for ‘‘Section 300aaa’’.
1990—Subsec. (f). Pub. L. 101–381 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
1988—Subsec. (f). Pub. L. 100–690 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
Pub. L. 100–607 substituted ‘‘300aaa’’ for ‘‘300cc’’.
1987—Pub. L. 100–202, which directed the amendment
of ‘‘Section 465(B) of 42 U.S.C. 286’’ by inserting ‘‘between (5) and (6) an additional charge to the Secretary
to ‘publicize the availability of the above products and
services of the National Library of Medicine’ ’’, was repealed by Pub. L. 103–43, § 1401(c)(1).
1986—Subsec. (f). Pub. L. 99–660 substituted ‘‘section
300cc of this title’’ for ‘‘section 300aa of this title’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Dec. 22, 1987,
see section 323 of Pub. L. 99–660, as amended, set out as
an Effective Date note under section 300aa–1 of this
title.
APPLICABILITY OF CERTAIN NEW AUTHORITY
Section 1401(c)(2) of Pub. L. 103–43 provided that:
‘‘With respect to the authority established for the National Library of Medicine in section 465(b)(6) of the
Public Health Service Act, as added by subsection (a) of
this section [subsec. (b)(6) of this section], such authority shall be effective as if the authority had been established on December 22, 1987.’’

§ 286a. Board of Regents
(a) Membership; ex officio members
(1)(A) The Board of Regents of the National
Library of Medicine consists of ex officio members and ten members appointed by the Secretary.
(B) The ex officio members are the Surgeons
General of the Public Health Service, the Army,
the Navy, and the Air Force, the Under Secretary for Health of the Department of Veterans
Affairs, the Dean of the Uniformed Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social Sciences of the National Science Foundation, the
Director of the National Agricultural Library,
and the Librarian of Congress (or their designees).
(C) The appointed members shall be selected
from among leaders in the various fields of the
fundamental sciences, medicine, dentistry, public health, hospital administration, pharmacology, health communications technology, or scientific or medical library work, or in public affairs. At least six of the appointed members
shall be selected from among leaders in the
fields of medical, dental, or public health research or education.
(2) The Board shall annually elect one of the
appointed members to serve as chairman until
the next election. The Secretary shall designate
a member of the Library staff to act as executive secretary of the Board.

Page 601

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Recommendations on matters of policy; recommendations included in annual report;
use of services of members by Secretary
The Board shall advise, consult with, and
make recommendations to the Secretary on
matters of policy in regard to the Library, including such matters as the acquisition of materials for the Library, the scope, content, and organization of the Library’s services, and the
rules under which its materials, publications, facilities, and services shall be made available to
various kinds of users. The Secretary shall include in the annual report of the Secretary to
the Congress a statement covering the recommendations made by the Board and the disposition thereof. The Secretary may use the services
of any member of the Board in connection with
matters related to the work of the Library, for
such periods, in addition to conference periods,
as the Secretary may determine.
(c) Term of office; vacancy; reappointment
Each appointed member of the Board shall
hold office for a term of four years, except that
any member appointed to fill a vacancy occurring prior to the expiration of the term for
which the predecessor of such member was appointed shall be appointed for the remainder of
such term. None of the appointed members shall
be eligible for reappointment within one year
after the end of the preceding term of such
member.
(July 1, 1944, ch. 373, title IV, § 466, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 859; amended
Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992,
106 Stat. 1985; Pub. L. 103–43, title XX,
§ 2008(b)(11), June 10, 1993, 107 Stat. 211.)
AMENDMENTS
1993—Subsec. (a)(1)(B). Pub. L. 103–43 substituted ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’.
1992—Subsec. (a)(1)(B). Pub. L. 102–405 substituted
‘‘Under Secretary for Health’’ for ‘‘Chief Medical Director’’.

§ 286a–1. Library facilities
The Administrator of General Services may
acquire, by purchase, condemnation, donation,
or otherwise, a suitable site or sites, selected by
the Secretary in accordance with the direction
of the Board, for suitable and adequate buildings
and facilities for use of the Library and to erect
thereon, furnish, and equip such buildings and
facilities. Amounts appropriated to carry out
this section may be used for the cost of preparation of drawings and specifications, supervision
of construction, and other administrative expenses incident to the work. The Administrator
of General Services shall prepare the plans and
specifications, make all necessary contracts,
and supervise construction.
(July 1, 1944, ch. 373, title IV, § 467, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 859; amended
Pub. L. 109–482, title I, § 103(b)(38), Jan. 15, 2007,
120 Stat. 3688.)
AMENDMENTS
2007—Pub. L. 109–482 substituted ‘‘for suitable and
adequate buildings and facilities for use of the Library’’ for ‘‘for such buildings and facilities’’ and

§ 286b–2

‘‘Amounts appropriated to carry out this section may
be used for’’ for ‘‘The amounts authorized to be appropriated by this section include’’ and struck out first
sentence which read as follows: ‘‘There are authorized
to be appropriated amounts sufficient for the erection
and equipment of suitable and adequate buildings and
facilities for use of the Library.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 286a–2. Repealed. Pub. L. 109–482, title I,
§ 103(b)(39), Jan. 15, 2007, 120 Stat. 3688
Section, act July 1, 1944, ch. 373, title IV, § 468, as
added Pub. L. 103–43, title XIV, § 1402(a), June 10, 1993,
107 Stat. 170, authorized appropriations for this part.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.
SUBPART 2—FINANCIAL ASSISTANCE

§ 286b. Repealed. Pub. L. 103–43, title
§ 1402(b), June 10, 1993, 107 Stat. 171

XIV,

Section, act July 1, 1944, ch. 373, title IV, § 469, as
added Nov. 20, 1985, Pub. L. 99–158, § 2, 99 Stat. 860;
amended Nov. 4, 1988, Pub. L. 100–607, title I, § 146(a), 102
Stat. 3058, authorized appropriations for grants and
contracts under sections 286b–3 through 286b–7 of this
title.

§ 286b–1. Definitions
As used in this subpart—
(1) the term ‘‘medical library’’ means a library related to the sciences related to health;
and
(2) the term ‘‘sciences related to health’’ includes medicine, osteopathy, dentistry, and
public health, and fundamental and applied
sciences when related thereto.
(July 1, 1944, ch. 373, title IV, § 470, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 860.)
§ 286b–2. National Medical Libraries Assistance
Advisory Board
(a) Board of Regents of National Library of Medicine to serve as
The Board of Regents of the National Library
of Medicine shall also serve as the National
Medical Libraries Assistance Advisory Board
(hereafter in this subpart referred to as the
‘‘Board’’).
(b) Functions
The Board shall advise and assist the Secretary in the preparation of general regulations
and with respect to policy matters arising in the
administration of this subpart.
(c) Use of services of members by Secretary
The Secretary may use the services of any
member of the Board, in connection with matters related to the administration of this part
for such periods, in addition to conference periods, as the Secretary may determine.

§ 286b–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Compensation
Appointed members of the Board who are not
otherwise in the employ of the United States,
while attending conferences of the Board or
otherwise serving at the request of the Secretary in connection with the administration of
this subpart, shall be entitled to receive compensation, per diem in lieu of subsistence, and
travel expenses in the same manner and under
the same conditions as that prescribed under
section 210(c) of this title when attending conferences, traveling, or serving at the request of
the Secretary in connection with the Board’s
function under this section.
(July 1, 1944, ch. 373, title IV, § 471, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 860.)
TERMINATION OF ADVISORY BOARDS
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President
or an officer of the Federal Government, such board is
renewed by appropriate action prior to the expiration
of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463,
Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 286b–3. Grants for training in medical library
sciences
The Secretary shall make grants—
(1) to individuals to enable them to accept
traineeships and fellowships leading to postbaccalaureate academic degrees in the field of
medical library science, in related fields pertaining to sciences related to health, or in the
field of the communication of information;
(2) to individuals who are librarians or specialists in information on sciences relating to
health, to enable them to undergo intensive
training or retraining so as to attain greater
competence in their occupations (including
competence in the fields of automatic data
processing and retrieval);
(3) to assist appropriate public and private
nonprofit institutions in developing, expanding, and improving training programs in library science and the field of communications
of information pertaining to sciences relating
to health; and
(4) to assist in the establishment of internship programs in established medical libraries
meeting standards which the Secretary shall
prescribe.
(July 1, 1944, ch. 373, title IV, § 472, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 860.)
§ 286b–4. Assistance for projects in sciences related to health, for research and development
in medical library science, and for development of education technologies
(a) Compilation of existing and original writings
on health
The Secretary shall make grants to physicians
and other practitioners in the sciences related

Page 602

to health, to scientists, and to public or nonprofit private institutions on behalf of such physicians, other practitioners, and scientists for
the compilation of existing, or the writing of
original, contributions relating to scientific, social, or cultural advancements in sciences related to health. In making such grants, the Secretary shall make appropriate arrangements
under which the facilities of the Library and the
facilities of libraries of public and private nonprofit institutions of higher learning may be
made available in connection with the projects
for which such grants are made.
(b) Medical library science and related activities
The Secretary shall make grants to appropriate public or private nonprofit institutions
and enter into contracts with appropriate persons, for purposes of carrying out projects of research, investigations, and demonstrations in
the field of medical library science and related
activities and for the development of new techniques, systems, and equipment, for processing,
storing, retrieving, and distributing information
pertaining to sciences related to health.
(c) Development of education technologies
(1) The Secretary shall make grants to public
or nonprofit private institutions for the purpose
of carrying out projects of research on, and development and demonstration of, new education
technologies.
(2) The purposes for which a grant under paragraph (1) may be made include projects concerning—
(A) computer-assisted teaching and testing
of clinical competence at health professions
and research institutions;
(B) the effective transfer of new information
from research laboratories to appropriate clinical applications;
(C) the expansion of the laboratory and clinical uses of computer-stored research databases; and
(D) the testing of new technologies for training health care professionals.
(3) The Secretary may not make a grant under
paragraph (1) unless the applicant for the grant
agrees to make the projects available with respect to—
(A) assisting in the training of health professions students; and
(B) enhancing and improving the capabilities
of health professionals regarding research and
teaching.
(July 1, 1944, ch. 373, title IV, § 473, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 861; amended
Pub. L. 103–43, title XIV, § 1411, June 10, 1993, 107
Stat. 171.)
AMENDMENTS
1993—Subsec. (c). Pub. L. 103–43 added subsec. (c).

§ 286b–5. Grants for establishing, expanding, and
improving basic resources of medical libraries and related instrumentalities
(a) The Secretary shall make grants of money,
materials, or both, to public or private nonprofit
medical libraries and related scientific communication instrumentalities for the purpose of establishing, expanding, and improving their basic

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medical library or related resources. A grant
under this subsection may be used for—
(1) the acquisition of books, journals, photographs, motion picture and other films, and
other similar materials;
(2) cataloging, binding, and other services
and procedures for processing library resource
materials for use by those who are served by
the library or related instrumentality;
(3) the acquisition of duplication devices,
facsimile equipment, film projectors, recording equipment, and other equipment to facilitate the use of the resources of the library or
related instrumentality by those who are
served by it; and
(4) the introduction of new technologies in
medical librarianship.
(b)(1) The amount of any grant under this section to any medical library or related instrumentality shall be determined by the Secretary
on the basis of the scope of library or related
services provided by such library or instrumentality in relation to the population and purposes
served by it. In making a determination of the
scope of services served by any medical library
or related instrumentality, the Secretary shall
take into account—
(A) the number of graduate and undergraduate students making use of the resources of
such library or instrumentality;
(B) the number of physicians and other practitioners in the sciences related to health utilizing the resources of such library or instrumentality;
(C) the type of supportive staffs, if any,
available to such library or instrumentality;
(D) the type, size, and qualifications of the
faculty of any school with which such library
or instrumentality is affiliated;
(E) the staff of any hospital or hospitals or
of any clinic or clinics with which such library
or instrumentality is affiliated; and
(F) the geographic area served by such library or instrumentality and the availability
within such area of medical library or related
services provided by other libraries or related
instrumentalities.
(2) Grants to such medical libraries or related
instrumentalities under this section shall be in
such amounts as the Secretary may by regulation prescribe with a view to assuring adequate
continuing financial support for such libraries
or instrumentalities from other sources during
and after the period for which grants are provided, except that in no case shall any grant
under this section to a medical library or related instrumentality for any fiscal year exceed
$1,000,000.
(July 1, 1944, ch. 373, title IV, § 474, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 861; amended
Pub. L. 100–607, title I, § 146(b), Nov. 4, 1988, 102
Stat. 3058; Pub. L. 103–43, title XIV, § 1401(b),
June 10, 1993, 107 Stat. 170.)
AMENDMENTS
1993—Subsec. (b)(2). Pub. L. 103–43
‘‘$1,000,000’’ for ‘‘$750,000’’.
1988—Subsec. (b)(2). Pub. L. 100–607
‘‘$750,000’’ for ‘‘$500,000’’.

substituted
substituted

§ 286b–6

§ 286b–6. Grants and contracts for establishment
of regional medical libraries
(a) Existing public or private nonprofit medical
libraries
The Secretary, with the advice of the Board,
shall make grants to and enter into contracts
with existing public or private nonprofit medical libraries so as to enable each of them to
serve as the regional medical library for the geographical area in which it is located.
(b) Uses for grants and contracts
The uses for which grants and contracts under
this section may be employed include the—
(1) acquisition of books, journals, and other
similar materials;
(2) cataloging, binding, and other procedures
for processing library resource materials for
use by those who are served by the library;
(3) acquisition of duplicating devices and
other equipment to facilitate the use of the resources of the library by those who are served
by it;
(4) acquisition of mechanisms and employment of personnel for the speedy transmission
of materials from the regional library to local
libraries in the geographic area served by the
regional library; and
(5) planning for services and activities under
this section.
(c) Conditions
(1) Grants and contracts under this section
shall only be made to or entered into with medical libraries which agree—
(A) to modify and increase their library resources, and to supplement the resources of
cooperating libraries in the region, so as to be
able to provide adequate supportive services to
all libraries in the region as well as to individual users of library services; and
(B) to provide free loan services to qualified
users and make available photoduplicated or
facsimile copies of biomedical materials which
qualified requesters may retain.
(2) The Secretary, in awarding grants and contracts under this section, shall give priority to
medical libraries having the greatest potential
of fulfilling the needs for regional medical libraries. In determining the priority to be assigned to any medical library, the Secretary
shall consider—
(A) the adequacy of the library (in terms of
collections, personnel, equipment, and other
facilities) as a basis for a regional medical library; and
(B) the size and nature of the population to
be served in the region in which the library is
located.
(d) Basic resources materials; limitation on grant
or contract
Grants and contracts under this section for
basic resource materials to a library may not
exceed—
(1) 50 percent of the library’s annual operating expense (exclusive of Federal financial assistance under this part) for the preceding
year; or
(2) in case of the first year in which the library receives a grant under this section for

§ 286b–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

basic resource materials, 50 percent of its average annual operating expenses over the past
three years (or if it had been in operation for
less than three years, its annual operating expenses determined by the Secretary in accordance with regulations).
(July 1, 1944, ch. 373, title IV, § 475, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 862.)
§ 286b–7. Financial support of biomedical scientific publications
(a) The Secretary, with the advice of the
Board, shall make grants to, and enter into appropriate contracts with, public or private nonprofit institutions of higher education and individual scientists for the purpose of supporting
biomedical scientific publications of a nonprofit
nature and to procure the compilation, writing,
editing, and publication of reviews, abstracts,
indices, handbooks, bibliographies, and related
matter pertaining to scientific works and scientific developments.
(b) Grants under subsection (a) of this section
in support of any single periodical publication
may not be made for more than three years, except in those cases in which the Secretary determines that further support is necessary to carry
out the purposes of subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, § 476, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 863.)
§ 286b–8. Grant payments, records, and audit
(a) Payments under grants made under sections 286b–3, 286b–4, 286b–5, 286b–6, and 286b–7 of
this title may be made in advance or by way of
reimbursement and in such installments as the
Secretary shall prescribe by regulation after
consultation with the Board.
(b)(1) Each recipient of a grant under this subpart shall keep such records as the Secretary
shall prescribe, including records which fully
disclose the amount and disposition by such recipient of the proceeds of such grant, the total
cost of the project or undertaking in connection
with which such grant is given or used, and the
amount of that portion of the cost of the project
or undertaking supplied by other sources, and
such other records as will facilitate an effective
audit.
(2) The Secretary and the Comptroller General
of the United States, or any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any
books, documents, papers, and records of such
recipients that are pertinent to any grant received under this subpart.
(July 1, 1944, ch. 373, title IV, § 477, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 863.)
SUBPART 3—NATIONAL CENTER FOR
BIOTECHNOLOGY INFORMATION

§ 286c. Purpose, establishment, functions, and
funding of National Center for Biotechnology
Information
(a) Establishment
In order to focus and expand the collection,
storage, retrieval, and dissemination of the re-

Page 604

sults of biotechnology research by information
systems, and to support and enhance the development of new information technologies to aid
in the understanding of the molecular processes
that control health and disease, there is established the National Center for Biotechnology Information (hereinafter in this section referred to
as the ‘‘Center’’) in the National Library of Medicine.
(b) Functions
The Secretary, through the Center and subject
to section 286(d) of this title, shall—
(1) design, develop, implement, and manage
automated systems for the collection, storage,
retrieval, analysis, and dissemination of
knowledge concerning human molecular biology, biochemistry, and genetics;
(2) perform research into advanced methods
of computer-based information processing capable of representing and analyzing the vast
number of biologically important molecules
and compounds;
(3) enable persons engaged in biotechnology
research and medical care to use systems developed under paragraph (1) and methods described in paragraph (2); and
(4) coordinate, as much as is practicable, efforts to gather biotechnology information on
an international basis.
(July 1, 1944, ch. 373, title IV, § 478, as added Pub.
L. 100–607, title I, § 105, Nov. 4, 1988, 102 Stat.
3052; amended Pub. L. 103–43, title XIV, § 1402(b),
June 10, 1993, 107 Stat. 171.)
AMENDMENTS
1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c)
which read as follows: ‘‘For the purpose of performing
the duties specified in subsection (b) of this section,
there are authorized to be appropriated $8,000,000 for
fiscal year 1989 and such sums as may be necessary for
fiscal year 1990. Funds appropriated under this subsection shall remain available until expended.’’
SUBPART 4—NATIONAL INFORMATION CENTER ON
HEALTH SERVICES RESEARCH AND HEALTH CARE
TECHNOLOGY

§ 286d. National Information Center
(a) Establishment
There is established within the Library an entity to be known as the National Information
Center on Health Services Research and Health
Care Technology (in this section referred to as
the ‘‘Center’’).
(b) Purpose
The purpose of the Center is the collection,
storage, analysis, retrieval, and dissemination
of information on health services research, clinical practice guidelines, and on health care technology, including the assessment of such technology. Such purpose includes developing and
maintaining data bases and developing and implementing methods of carrying out such purpose.
(c) Electronic, convenient format; criteria for inclusion
The Director of the Center shall ensure that
information under subsection (b) of this section
concerning clinical practice guidelines is col-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

lected and maintained electronically and in a
convenient format. Such Director shall develop
and publish criteria for the inclusion of practice
guidelines and technology assessments in the information center database.
(d) Coordination with Director of the Agency for
Healthcare Research and Quality
The Secretary, acting through the Center,
shall coordinate the activities carried out under
this section through the Center with related activities of the Director of the Agency for Healthcare Research and Quality.
(July 1, 1944, ch. 373, title IV, § 478A, as added
Pub. L. 103–43, title XIV, § 1421, June 10, 1993, 107
Stat. 171; amended Pub. L. 106–129, § 2(b)(2), Dec.
6, 1999, 113 Stat. 1670.)
AMENDMENTS
1999—Subsec. (d). Pub. L. 106–129 substituted ‘‘Director of the Agency for Healthcare Research and Quality’’ for ‘‘Administrator for Health Care Policy and Research’’.
CONSTRUCTION
Section 1422(b) of Pub. L. 103–43 provided that: ‘‘The
amendments made by section 3 of Public Law 102–410
(106 Stat. 2094) [amending section 299a–1 of this title],
by section 1421 of this Act [enacting this section], and
by subsection (a) of this section [amending section
299a–1 of this title] may not be construed as terminating the information center on health care technologies
and health care technology assessment established
under section 904 of the Public Health Service Act [section 299a–2 of this title], as in effect on the day before
the date of the enactment of Public Law 102–410 [Oct.
13, 1992]. Such center shall be considered to be the center established in section 478A of the Public Health
Service Act, as added by section 1421 of this Act [this
section], and shall be subject to the provisions of such
section 478A.’’

PART E—OTHER AGENCIES OF NIH
SUBPART 1—NATIONAL CENTER FOR RESEARCH
RESOURCES

§ 287. General purpose
The general purpose of the National Center for
Research Resources (in this subpart referred to
as the ‘‘Center’’) is to strengthen and enhance
the research environments of entities engaged in
health-related research by developing and supporting essential research resources.
(July 1, 1944, ch. 373, title IV, § 479, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 864; amended
Pub. L. 103–43, title XV, § 1501(2)(B), June 10, 1993,
107 Stat. 172.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘the National Center
for Research Resources (in this subpart referred to as
the ‘Center’)’’ for ‘‘the Division of Research Resources’’.
SHARED INSTRUMENTATION GRANT PROGRAM
Pub. L. 106–505, title III, § 305, Nov. 13, 2000, 114 Stat.
2335, provided that:
‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $100,000,000 for fiscal year
2000, and such sums as may be necessary for each subsequent fiscal year, to enable the Secretary of Health and
Human Services, acting through the Director of the National Center for Research Resources, to provide for the

§ 287a

continued operation of the Shared Instrumentation
Grant Program (initiated in fiscal year 1992 under the
authority of section 479 of the Public Health Service
Act (42 U.S.C. 287 et seq.)).
‘‘(b) REQUIREMENTS FOR GRANTS.—In determining
whether to award a grant to an applicant under the
program described in subsection (a), the Director of the
National Center for Research Resources shall consider—
‘‘(1) the extent to which an award for the specific
instrument involved would meet the scientific needs
and enhance the planned research endeavors of the
major users by providing an instrument that is unavailable or to which availability is highly limited;
‘‘(2) with respect to the instrument involved, the
availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation;
‘‘(3) the adequacy of the organizational plan for the
use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any;
‘‘(4) the applicant’s commitment for continued support of the utilization and maintenance of the instrument; and
‘‘(5) the extent to which the specified instrument
will be shared and the benefit of the proposed instrument to the overall research community to be served.
‘‘(c) PEER REVIEW.—In awarding grants under the program described in subsection (a)[, the] Director of the
National Center for Research Resources shall comply
with the peer review requirements in section 492 of the
Public Health Service Act (42 U.S.C. 289a).’’

§ 287a. Advisory council
(a) Appointment; functions and duties; acceptance of conditional gifts; subcommittees
(1) The Secretary shall appoint an advisory
council for the Center which shall advise, assist,
consult with, and make recommendations to the
Secretary and the Director of the Center on
matters related to the activities carried out by
and through the Center and the policies respecting such activities.
(2) The advisory council for the Center may
recommend to the Secretary acceptance, in accordance with section 238 of this title, of conditional gifts for study, investigations, and research and for the acquisition of grounds or construction, equipping, or maintenance of facilities for the Center.
(3) The advisory council for the Center—
(A)(i) may make recommendations to the Director of the Center respecting research conducted at the Center,
(ii) may review applications for grants and
cooperative agreements for research or training and recommend for approval applications
for projects which show promise of making
valuable contributions to human knowledge,
and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or
entered into by the Center;
(B) may collect, by correspondence or by
personal investigation, information as to studies which are being carried on in the United
States or any other country as to the diseases,
disorders, or other aspects of human health
with respect to which the Center is concerned
and with the approval of the Director of the
Center make available such information
through appropriate publications for the benefit of public and private health entities and

§ 287a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health professions personnel and scientists
and for the information of the general public;
and
(C) may appoint subcommittees and convene
workshops and conferences.
(b) Membership; ex officio members; compensation
(1) The advisory council shall consist of ex
officio members and not more than eighteen
members appointed by the Secretary.
(2) The ex officio members of the advisory
council shall consist of—
(A) the Secretary, the Director of NIH, the
Director of the Center, the Under Secretary
for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense
for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of
the United States as the Secretary determines
necessary for the advisory council to effectively carry out its functions.
(3) The members of the advisory council who
are not ex officio members shall be appointed as
follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific
disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Center.
(B) One-third of the members shall be appointed by the Secretary from the general
public and shall include leaders in fields of
public policy, law, health policy, economics,
and management.
(4) Members of the advisory council who are
officers or employees of the United States shall
not receive any compensation for service on the
advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the
daily equivalent of the annual rate in effect for
grade GS–18 of the General Schedule.
(c) Term of office; vacancy; reappointment
The term of office of an appointed member of
the advisory council is four years, except that
any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such term and the Secretary shall
make appointments to an advisory council in
such a manner as to ensure that the terms of the
members do not all expire in the same year. A
member may serve after the expiration of the
member’s term until a successor has taken office. A member who has been appointed for a
term of four years may not be reappointed to an
advisory council before two years from the date
of expiration of such term of office. If a vacancy
occurs in the advisory council among the appointed members, the Secretary shall make an
appointment to fill the vacancy within 90 days
from the date the vacancy occurs.
(d) Chairman; selection; term of office
The chairman of the advisory council shall be
selected by the Secretary from among the ap-

Page 606

pointed members, except that the Secretary
may select the Director of the Center to be the
chairman of the advisory council. The term of
office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of
the chairman or upon the request of the Director of the Center, but at least three times each
fiscal year. The location of the meetings of the
advisory council is subject to the approval of
the Director of the Center.
(f) Executive secretary; staff; orientation and
training for new members
The Director of the Center shall designate a
member of the staff of the Center to serve as the
executive secretary of the advisory council. The
Director of the Center shall make available to
the advisory council such staff, information, and
other assistance as it may require to carry out
its functions. The Director of the Center shall
provide orientation and training for new members of the advisory council to provide them
with such information and training as may be
appropriate for their effective participation in
the functions of the advisory council.
(g) Material for inclusion in biennial report; additional reports
The advisory council may prepare, for inclusion in the biennial report made under section
287a–1 of this title, (1) comments respecting the
activities of the advisory council in the fiscal
years respecting which the report is prepared,
(2) comments on the progress of the Center in
meeting its objectives, and (3) recommendations
respecting the future directions and program
and policy emphasis of the Center. The advisory
council may prepare such additional reports as
it may determine appropriate.
(h) Advisory council in existence on November
20, 1985
This section does not terminate the membership of the advisory council for the Center which
was in existence on November 20, 1985. After November 20, 1985—
(1) the Secretary shall make appointments
to such advisory council in such a manner as
to bring about as soon as practicable the composition for such council prescribed by this
section;
(2) the advisory council shall organize itself
in accordance with this section and exercise
the functions prescribed by this section; and
(3) the Director of the Center shall perform
for such advisory council the functions prescribed by this section.
(July 1, 1944, ch. 373, title IV, § 480, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 864; amended
Pub. L. 101–381, title I, § 102(3), Aug. 18, 1990, 104
Stat. 586; Pub. L. 102–405, title III, § 302(e)(1), Oct.
9, 1992, 106 Stat. 1985; Pub. L. 103–43, title XV,
§ 1501(2)(C), (D), title XX, §§ 2008(b)(12), 2010(b)(4),
June 10, 1993, 107 Stat. 172, 173, 211, 214.)
AMENDMENTS
1993—Subsec. (a)(1). Pub. L. 103–43, § 1501(2)(C), (D),
substituted ‘‘the Center’’ for ‘‘the Division of Research
Resources’’ after ‘‘advisory council for’’ and substituted ‘‘the Center’’ for ‘‘the Division’’ in two places.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a)(2). Pub. L. 103–43, §§ 1501(2)(C), (D),
2010(b)(4), substituted ‘‘the Center’’ for ‘‘the Division of
Research Resources’’ after ‘‘advisory council for’’, ‘‘section 238’’ for ‘‘section 300aaa’’, and ‘‘the Center’’ for
‘‘the Division’’.
Subsec. (a)(3). Pub. L. 103–43, § 1501(2)(D), substituted
‘‘the Center’’ for ‘‘the Division’’ wherever appearing.
Subsec. (b). Pub. L. 103–43, §§ 1501(2)(C), (D), 2008(b)(12),
in par. (2)(A) substituted ‘‘the Center’’ for ‘‘the Division of Research Resources’’ and ‘‘Department of Veterans Affairs’’ for ‘‘Veterans’ Administration’’ and in par.
(3)(A) substituted ‘‘the Center’’ for ‘‘the Division’’.
Subsec. (d). Pub. L. 103–43, § 1501(2)(C), substituted
‘‘the Center’’ for ‘‘the Division of Research Resources’’.
Subsec. (e). Pub. L. 103–43, § 1501(2)(C), (D), substituted
‘‘the Center’’ for ‘‘the Division of Research Resources’’
and ‘‘the Center’’ for ‘‘the Division’’.
Subsec. (f). Pub. L. 103–43, § 1501(2)(C), (D), substituted
‘‘the Center’’ for ‘‘the Division of Research Resources’’
and ‘‘the Center’’ for ‘‘the Division’’ in three places.
Subsec. (g). Pub. L. 103–43, § 1501(2)(C), (D), substituted ‘‘the Center’’ for ‘‘the Division of Research Resources’’ and ‘‘the Center’’ for ‘‘the Division’’.
Subsec. (h). Pub. L. 103–43, § 1501(2)(C), substituted
‘‘the Center’’ for ‘‘the Division of Research Resources’’
in introductory provisions and in par. (3).
1992—Subsec. (b)(2)(A). Pub. L. 102–405 substituted
‘‘Under Secretary for Health’’ for ‘‘Chief Medical Director’’.
1990—Subsec. (a)(2). Pub. L. 101–381 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by the Congress, its duration is
otherwise provided by law. See sections 3(2) and 14 of
Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in
the Appendix to Title 5, Government Organization and
Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 287a–1. Biennial report
The Director of the Center, after consultation
with the advisory council for the Center, shall
prepare for inclusion in the biennial report made
under section 283 of this title a biennial report
which shall consist of a description of the activities of the Center and program policies of the
Director of the Center in the fiscal years respecting which the report is prepared. The Director of the Center may prepare such additional reports as the Director determines appropriate. The Director of the Center shall provide
the advisory council of the Center an oppor-

§ 287a–2

tunity for the submission of the written comments referred to in section 287a(g) of this title.
(July 1, 1944, ch. 373, title IV, § 481, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 866; amended
Pub. L. 103–43, title XV, § 1501(2)(C), (D), June 10,
1993, 107 Stat. 172, 173.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘the Center’’ for ‘‘the
Division of Research Resources’’ and ‘‘the Center’’ for
‘‘the Division’’ wherever appearing.

§ 287a–2. Biomedical and behavioral research facilities
(a) Modernization and construction of facilities
(1) In general
The Director of NIH, acting through the Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases, may make grants or contracts to public
and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities,
subject to the provisions of this section.
(2) Construction and cost of construction
For purposes of this section, the terms ‘‘construction’’ and ‘‘cost of construction’’ include
the construction of new buildings and the expansion, renovation, remodeling, and alteration of existing buildings, including architects’ fees, but do not include the cost of acquisition of land or off-site improvements.
(b) Scientific and technical review boards for
merit-based review of proposals
(1) In general: approval as precondition to
grants
(A) Establishment
There is established within the Center a
Scientific and Technical Review Board on
Biomedical and Behavioral Research Facilities (referred to in this section as the
‘‘Board’’).
(B) Requirement
The Director of the Center may approve an
application for a grant under subsection (a)
of this section only if the Board has under
paragraph (2) recommended the application
for approval.
(2) Duties
(A) Advice
The Board shall provide advice to the Director of the Center and the advisory council
established under section 287a of this title
(in this section referred to as the ‘‘Advisory
Council’’) in carrying out this section.
(B) Determination of merit
In carrying out subparagraph (A), the
Board shall make a determination of the
merit of each application submitted for a
grant under subsection (a) of this section,
after consideration of the requirements established in subsection (c) of this section,
and shall report the results of the determination to the Director of the Center and
the Advisory Council. Such determinations
shall be conducted in a manner consistent

§ 287a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

with procedures established under section
289a of this title.
(C) Amount
In carrying out subparagraph (A), the
Board shall, in the case of applications recommended for approval, make recommendations to the Director and the Advisory Council on the amount that should be provided
under the grant.
(D) Annual report
In carrying out subparagraph (A), the
Board shall prepare an annual report for the
Director of the Center and the Advisory
Council describing the activities of the
Board in the fiscal year for which the report
is made. Each such report shall be available
to the public, and shall—
(i) summarize and analyze expenditures
made under this section;
(ii) provide a summary of the types,
numbers, and amounts of applications that
were recommended for grants under subsection (a) of this section but that were
not approved by the Director of the Center; and
(iii) contain the recommendations of the
Board for any changes in the administration of this section.
(3) Membership
(A) In general
Subject to subparagraph (B), the Board
shall be composed of 15 members to be appointed by the Director of the Center, and
such ad-hoc or temporary members as the
Director of the Center determines to be appropriate. All members of the Board, including temporary and ad-hoc members, shall be
voting members.
(B) Limitation
Not more than three individuals who are
officers or employees of the Federal Government may serve as members of the Board.
(4) Certain requirements regarding membership
In selecting individuals for membership on
the Board, the Director of the Center shall ensure that the members are individuals who, by
virtue of their training or experience, are eminently qualified to perform peer review functions. In selecting such individuals for such
membership, the Director of the Center shall
ensure that the members of the Board collectively—
(A) are experienced in the planning, construction, financing, and administration of
entities that conduct biomedical or behavioral research sciences;
(B) are knowledgeable in making determinations of the need of entities for biomedical or behavioral research facilities, including such facilities for the dentistry,
nursing, pharmacy, and allied health professions;
(C) are knowledgeable in evaluating the
relative priorities for applications for grants
under subsection (a) of this section in view
of the overall research needs of the United
States; and

Page 608

(D) are experienced with emerging centers
of excellence, as described in subsection
(c)(2) of this section.
(5) Certain authorities
(A) Workshops and conferences
In carrying out paragraph (2), the Board
may convene workshops and conferences,
and collect data as the Board considers appropriate.
(B) Subcommittees
In carrying out paragraph (2), the Board
may establish subcommittees within the
Board. Such subcommittees may hold meetings as determined necessary to enable the
subcommittee to carry out its duties.
(6) Terms
(A) In general
Except as provided in subparagraph (B),
each appointed member of the Board shall
hold office for a term of 4 years. Any member appointed to fill a vacancy occurring
prior to the expiration of the term for which
such member’s predecessor was appointed
shall be appointed for the remainder of the
term of the predecessor.
(B) Staggered terms
Members appointed to the Board shall
serve staggered terms as specified by the Director of the Center when making the appointments.
(C) Reappointment
No member of the Board shall be eligible
for reappointment to the Board until 1 year
has elapsed after the end of the most recent
term of the member.
(7) Compensation
Members of the Board who are not officers
or employees of the United States shall receive for each day the members are engaged in
the performance of the functions of the Board
compensation at the same rate received by
members of other national advisory councils
established under this subchapter.
(c) Requirements for grants
(1) In general
The Director of the Center or the Director of
the National Institute of Allergy and Infectious Diseases may make a grant under subsection (a) of this section only if the applicant
for the grant meets the following conditions:
(A) The applicant is determined by such
Director to be competent to engage in the
type of research for which the proposed facility is to be constructed.
(B) The applicant provides assurances satisfactory to the Director that—
(i) for not less than 20 years after completion of the construction involved, the
facility will be used for the purposes of the
research for which it is to be constructed;
(ii) sufficient funds will be available to
meet the non-Federal share of the cost of
constructing the facility;
(iii) sufficient funds will be available,
when construction is completed, for the ef-

Page 609

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fective use of the facility for the research
for which it is being constructed; and
(iv) the proposed construction will expand the applicant’s capacity for research,
or is necessary to improve or maintain the
quality of the applicant’s research.
(C) The applicant meets reasonable qualifications established by the Director with
respect to—
(i) the relative scientific and technical
merit of the applications, and the relative
effectiveness of the proposed facilities, in
expanding the capacity for biomedical or
behavioral research and in improving the
quality of such research;
(ii) the quality of the research or training, or both, to be carried out in the facilities involved;
(iii) the congruence of the research activities to be carried out within the facility with the research and investigator
manpower needs of the United States; and
(iv) the age and condition of existing research facilities.
(D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of the applicant.
(2) Institutions of emerging excellence
From the amount appropriated to carry out
this section for a fiscal year up to $50,000,000,
the Director of the Center shall make available 25 percent of such amount, and from the
amount appropriated to carry out this section
for a fiscal year that is over $50,000,000, the Director of the Center shall make available up to
25 percent of such amount, for grants under
subsection (a) of this section to applicants
that in addition to meeting the requirements
established in paragraph (1), have demonstrated emerging excellence in biomedical
or behavioral research, as follows:
(A) The applicant has a plan for research
or training advancement and possesses the
ability to carry out the plan.
(B) The applicant carries out research and
research training programs that have a special relevance to a problem, concern, or
unmet health need of the United States.
(C) The applicant has been productive in
research or research development and training.
(D) The applicant—
(i) has been designated as a center of excellence under section 293c 1 of this title;
(ii) is located in a geographic area whose
population includes a significant number
of individuals with health status deficit,
and the applicant provides health services
to such individuals; or
(iii) is located in a geographic area in
which a deficit in health care technology,
services, or research resources may adversely affect the health status of the population of the area in the future, and the
applicant is carrying out activities with
respect to protecting the health status of
such population.
1 See

References in Text note below.

§ 287a–2

(d) Requirement of application
The Director of the Center or the Director of
the National Institute of Allergy and Infectious
Diseases may make a grant under subsection (a)
of this section only if an application for the
grant is submitted to the Director and the application is in such form, is made in such manner,
and contains such agreements, assurances, and
information as the Director determines to be
necessary to carry out this section.
(e) Amount of grant; payments
(1) Amount
The amount of any grant awarded under subsection (a) of this section shall be determined
by the Director of the Center or the Director
of the National Institute of Allergy and Infectious Diseases, except that such amount shall
not exceed—
(A) 50 percent (or, in the case of the Institute, 75 percent) of the necessary cost of the
construction of a proposed facility as determined by the Director; or
(B) in the case of a multipurpose facility,
40 percent (or, in the case of the Institute, 75
percent) of that part of the necessary cost of
construction that the Director determines to
be proportionate to the contemplated use of
the facility.
(2) Reservation of amounts
On the approval of any application for a
grant under subsection (a) of this section, the
Director of the Center or the Director of the
National Institute of Allergy and Infectious
Diseases shall reserve, from any appropriation
available for such grants, the amount of such
grant, and shall pay such amount, in advance
or by way of reimbursement, and in such installments consistent with the construction
progress, as the Director may determine appropriate. The reservation of any amount by
the Director under this paragraph may be
amended by the Director, either on the approval of an amendment of the application or
on the revision of the estimated cost of construction of the facility.
(3) Exclusion of certain costs
In determining the amount of any grant
under subsection (a) of this section, there
shall be excluded from the cost of construction
an amount equal to the sum of—
(A) the amount of any other Federal grant
that the applicant has obtained, or is assured of obtaining, with respect to construction that is to be financed in part by a grant
authorized under this section; and
(B) the amount of any non-Federal funds
required to be expended as a condition of
such other Federal grant.
(4) Waiver of limitations
The limitations imposed under paragraph (1)
may be waived at the discretion of the Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases for applicants meeting the conditions described in subsection (c) of this section.
(f) Recapture of payments
If, not later than 20 years after the completion
of construction for which a grant has been
awarded under subsection (a) of this section—

§ 287a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) in the case of an award by the Director of
the Center, the applicant or other owner of the
facility shall cease to be a public or non profit 2 private entity; or
(2) the facility shall cease to be used for the
research purposes for which it was constructed
(unless the Director of the Center or the Director of the National Institute of Allergy and
Infectious Diseases determines, in accordance
with regulations, that there is good cause for
releasing the applicant or other owner from
obligation to do so),
the United States shall be entitled to recover
from the applicant or other owner of the facility
the amount bearing the same ratio to the current value (as determined by an agreement between the parties or by action brought in the
United States District Court for the district in
which such facility is situated) of the facility as
the amount of the Federal participation bore to
the cost of the construction of such facility.
(g) Guidelines
Not later than 6 months after June 10, 1993,
the Director of the Center, after consultation
with the Advisory Council, shall issue guidelines
with respect to grants under subsection (a) of
this section.
(July 1, 1944, ch. 373, title IV, § 481A, as added
Pub. L. 103–43, title XV, § 1502, June 10, 1993, 107
Stat. 173; amended Pub. L. 105–392, title I,
§ 101(c), Nov. 13, 1998, 112 Stat. 3537; Pub. L.
106–505, title III, § 303, Nov. 13, 2000, 114 Stat. 2330;
Pub. L. 108–276, § 2(b), July 21, 2004, 118 Stat. 841;
Pub. L. 109–482, title I, §§ 103(b)(40), 104(b)(1)(M),
Jan. 15, 2007, 120 Stat. 3688, 3693.)
REFERENCES IN TEXT
Section 293c of this title, referred to in subsec.
(c)(2)(D)(i), does not contain provisions relating to designation as a center of excellence. See section 293 of
this title.
AMENDMENTS
2007—Subsec. (c)(2). Pub. L. 109–482, § 103(b)(40)(A), in
introductory provisions, substituted ‘‘to carry out this
section for a fiscal year up to’’ for ‘‘under subsection
(i)(1) of this section for a fiscal year up to’’ and ‘‘to
carry out this section for a fiscal year that’’ for ‘‘under
such subsection for a fiscal year that’’.
Subsec. (h). Pub. L. 109–482, § 104(b)(1)(M), struck out
subsec. (h) which required biennial report concerning
the status of biomedical and behavioral research facilities and the availability and condition of laboratory
equipment.
Subsec. (i). Pub. L. 109–482, § 103(b)(40)(B), struck out
subsec. (i) which authorized appropriations for the National Center for Research Resources and the National
Institute of Allergy and Infectious Diseases.
2004—Subsec. (a)(1). Pub. L. 108–276, § 2(b)(1), inserted
‘‘or the Director of the National Institute of Allergy
and Infectious Diseases’’ after ‘‘Director of the Center’’.
Subsec. (c)(1). Pub. L. 108–276, § 2(b)(2)(A), inserted ‘‘or
the Director of the National Institute of Allergy and
Infectious Diseases’’ after ‘‘Director of the Center’’.
Subsec. (c)(2). Pub. L. 108–276, § 2(b)(2)(B), substituted
‘‘subsection (i)(1)’’ for ‘‘subsection (i)’’ in introductory
provisions.
Subsec. (d). Pub. L. 108–276, § 2(b)(3), inserted ‘‘or the
Director of the National Institute of Allergy and Infectious Diseases’’ after ‘‘Director of the Center’’.
2 So

in original. Probably should be ‘‘nonprofit’’.

Page 610

Subsec. (e)(1). Pub. L. 108–276, § 2(b)(4)(A)(i), inserted
‘‘or the Director of the National Institute of Allergy
and Infectious Diseases’’ after ‘‘Director of the Center’’
in introductory provisions.
Subsec. (e)(1)(A). Pub. L. 108–276, § 2(b)(4)(A)(ii), inserted ‘‘(or, in the case of the Institute, 75 percent)’’
after ‘‘50 percent’’.
Subsec. (e)(1)(B). Pub. L. 108–276, § 2(b)(4)(A)(iii), inserted ‘‘(or, in the case of the Institute, 75 percent)’’
after ‘‘40 percent’’.
Subsec. (e)(2). Pub. L. 108–276, § 2(b)(4)(B), inserted ‘‘or
the Director of the National Institute of Allergy and
Infectious Diseases’’ after ‘‘Director of the Center’’.
Subsec. (e)(4). Pub. L.108–276, § 2(b)(4)(C), inserted ‘‘of
the Center or the Director of the National Institute of
Allergy and Infectious Diseases’’ after ‘‘Director’’.
Subsec. (f)(1). Pub. L. 108–276, § 2(b)(5)(A), inserted ‘‘in
the case of an award by the Director of the Center,’’ before ‘‘the applicant’’.
Subsec. (f)(2). Pub. L. 108–276, § 2(b)(5)(B), inserted ‘‘of
the Center or the Director of the National Institute of
Allergy and Infectious Diseases’’ after ‘‘Director’’.
Subsec. (i). Pub. L. 108–276, § 2(b)(6), designated existing provisions as par. (1), inserted heading, substituted
‘‘For the purpose of carrying out this section with respect to the Center,’’ for ‘‘For the purpose of carrying
out this section,’’, and added par. (2).
2000—Pub. L. 106–505 amended section generally, adding provisions requiring the Director to provide Congress with biennial status reports.
1998—Subsec. (c)(3)(D)(i). Pub. L. 105–392 substituted
‘‘part B of subchapter V of this chapter’’ for ‘‘section
293c of this title’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
FINDINGS
Pub. L. 106–505, title III, § 302, Nov. 13, 2000, 114 Stat.
2330, provided that: ‘‘Congress finds that—
‘‘(1) the National Institutes of Health is the principal source of Federal funding for medical research
at universities and other research institutions in the
United States;
‘‘(2) the National Institutes of Health has received
a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research;
‘‘(3) the infrastructure of our research institutions
is central to the continued leadership of the United
States in medical research;
‘‘(4) as Congress increases the investment in cutting-edge basic and clinical research, it is critical
that Congress also examine the current quality of the
laboratories and buildings where research is being
conducted, as well as the quality of laboratory equipment used in research;
‘‘(5) many of the research facilities and laboratories
in the United States are outdated and inadequate;
‘‘(6) the National Science Foundation found, in a
1998 report on the status of biomedical research facilities, that over 60 percent of research-performing
institutions indicated that they had an inadequate
amount of medical research space;
‘‘(7) the National Science Foundation reports that
academic
institutions
have
deferred
nearly
$11,000,000,000 in renovation and construction projects
because of a lack of funds; and
‘‘(8) future increases in Federal funding for the National Institutes of Health must include increased
support for the renovation and construction of extramural research facilities in the United States and the
purchase of state-of-the-art laboratory instrumentation.’’

Page 611

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 287a–3. Construction of regional centers for research on primates
(a) With respect to activities carried out by
the National Center for Research Resources to
support regional centers for research on primates, the Director of NIH may, for each of the
fiscal years 2000 through 2002, reserve from the
amounts appropriated to carry out section
287a–2 of this title such sums as necessary for
the purpose of making awards of grants and contracts to public or nonprofit private entities to
construct, renovate, or otherwise improve such
regional centers. The reservation of such
amounts for any fiscal year is subject to the
availability of qualified applicants for such
awards.
(b) The Director of NIH may not make a grant
or enter into a contract under subsection (a) of
this section unless the applicant for such assistance agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such subsection, to make
available (directly or through donations from
public or private entities) non-Federal contributions in cash toward such costs in an amount
equal to not less than $1 for each $4 of Federal
funds provided in such assistance.
(July 1, 1944, ch. 373, title IV, § 481B, as added
Pub. L. 103–43, title XV, § 1503, June 10, 1993, 107
Stat. 178; amended Pub. L. 105–392, title IV, § 411,
Nov. 13, 1998, 112 Stat. 3590; Pub. L. 106–505, title
III, § 304, Nov. 13, 2000, 114 Stat. 2335; Pub. L.
109–482, title I, § 103(b)(41), Jan. 15, 2007, 120 Stat.
3688.)
AMENDMENTS
2007—Subsec. (a). Pub. L. 109–482, which directed the
substitution of ‘‘to carry out section 287a–2’’ for ‘‘under
section 287a–2(h)’’, was executed by making substitution for ‘‘under section 287a–2(i)’’, to reflect the probable intent of Congress.
2000—Subsec. (a). Pub. L. 106–505, which directed the
amendment of subsec. (a) by substituting ‘‘2000 through
2002, reserve from the amounts appropriated under section 287a–2(i) of this title such sums as necessary’’ for
‘‘ ‘1994’ and all that follows through ‘$5,000,000’ ’’, was
executed by making the substitution for ‘‘1994 through
1996, reserve from the amounts appropriated under section 287a–2(h) of this title up to $2,500,000’’, to reflect
the probable intent of Congress and the amendment by
Pub. L. 105–392. See 1998 Amendment note below.
1998—Subsec. (a). Pub. L. 105–392, in first sentence,
substituted ‘‘may’’ for ‘‘shall’’ and ‘‘up to $2,500,000’’ for
‘‘$5,000,000’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 287a–3a. Sanctuary system for surplus chimpanzees
(a) In general
The Secretary shall provide for the establishment and operation in accordance with this section of a system to provide for the lifetime care
of chimpanzees that have been used, or were
bred or purchased for use, in research conducted
or supported by the National Institutes of
Health, the Food and Drug Administration, or
other agencies of the Federal Government, and

§ 287a–3a

with respect to which it has been determined by
the Secretary that the chimpanzees are not
needed for such research (in this section referred
to as ‘‘surplus chimpanzees’’).
(b) Administration of sanctuary system
The Secretary shall carry out this section, including the establishment of regulations under
subsection (d) of this section, in consultation
with the board of directors of the nonprofit private entity that receives the contract under
subsection (e) of this section (relating to the operation of the sanctuary system).
(c) Acceptance of chimpanzees into system
All surplus chimpanzees owned by the Federal
Government shall be accepted into the sanctuary system. Subject to standards under subsection (d)(4) of this section, any chimpanzee
that is not owned by the Federal Government
can be accepted into the system if the owner
transfers to the sanctuary system title to the
chimpanzee.
(d) Standards for permanent retirement of surplus chimpanzees
(1) In general
Not later than 180 days after December 20,
2000, the Secretary shall by regulation establish standards for operating the sanctuary system to provide for the permanent retirement
of surplus chimpanzees. In establishing the
standards, the Secretary shall consider the
recommendations of the board of directors of
the nonprofit private entity that receives the
contract under subsection (e) of this section,
and shall consider the recommendations of the
National Research Council applicable to surplus chimpanzees that are made in the report
published in 1997 and entitled ‘‘Chimpanzees in
Research—Strategies for Their Ethical Care,
Management, and Use’’.
(2) Chimpanzees accepted into system
With respect to chimpanzees that are accepted into the sanctuary system, standards
under paragraph (1) shall include the following:
(A) A prohibition that the chimpanzees
may not be used for research, except as authorized under paragraph (3).
(B) Provisions regarding the housing of the
chimpanzees.
(C) Provisions regarding the behavioral
well-being of the chimpanzees.
(D) A requirement that the chimpanzees be
cared for in accordance with the Animal
Welfare Act [7 U.S.C. 2131 et seq.].
(E) A requirement that the chimpanzees be
prevented from breeding.
(F) A requirement that complete histories
be maintained on the health and use in research of the chimpanzees.
(G) A requirement that the chimpanzees be
monitored for the purpose of promptly detecting the presence in the chimpanzees of
any condition that may be a threat to the
public health or the health of other chimpanzees.
(H) A requirement that chimpanzees posing such a threat be contained in accordance
with applicable recommendations of the Di-

§ 287a–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

rector of the Centers for Disease Control and
Prevention.
(I) A prohibition that none of the chimpanzees may be subjected to euthanasia, except as in the best interests of the chimpanzee involved, as determined by the system and an attending veterinarian.
(J) A prohibition that the chimpanzees
may not be discharged from the system.
(K) A provision that the Secretary may, in
the discretion of the Secretary, accept into
the system chimpanzees that are not surplus
chimpanzees.
(L) Such additional standards as the Secretary determines to be appropriate.
(3) Restrictions regarding research
(A) In general
For purposes of paragraph (2)(A), standards
under paragraph (1) shall provide that a
chimpanzee accepted into the sanctuary system may not be used for studies or research,
except that the chimpanzee may be used for
noninvasive behavioral studies or medical
studies based on information collected during the course of normal veterinary care
that is provided for the benefit of the chimpanzee, provided that any such study involves minimal physical and mental harm,
pain, distress, and disturbance to the chimpanzee and the social group in which the
chimpanzee lives.
(B) Additional restriction
For purposes of paragraph (2)(A), a condition for the use in studies or research of a
chimpanzee accepted into the sanctuary system is (in addition to conditions under subparagraph (A) of this paragraph) that the applicant for such use has not been fined for,
or signed a consent decree for, any violation
of the Animal Welfare Act [7 U.S.C. 2131 et
seq.].
(4) Non-Federal chimpanzees offered for acceptance into system
With respect to a chimpanzee that is not
owned by the Federal Government and is offered for acceptance into the sanctuary system, standards under paragraph (1) shall include the following:
(A) A provision that the Secretary may authorize the imposition of a fee for accepting
such chimpanzee into the system, except as
follows:
(i) Such a fee may not be imposed for accepting the chimpanzee if, on the day before December 20, 2000, the chimpanzee was
owned by the nonprofit private entity that
receives the contract under subsection (e)
of this section or by any individual sanctuary facility receiving a subcontract or
grant under subsection (e)(1) of this section.
(ii) Such a fee may not be imposed for
accepting the chimpanzee if the chimpanzee is owned by an entity that operates
a primate center, and if the chimpanzee is
housed in the primate center pursuant to
the program for regional centers for research on primates that is carried out by
the National Center for Research Resources.

Page 612

Any fees collected under this subparagraph
are available to the Secretary for the costs
of operating the system. Any other fees received by the Secretary for the long-term
care of chimpanzees (including any Federal
fees that are collected for such purpose and
are identified in the report under section 3 of
the Chimpanzee Health Improvement, Maintenance, and Protection Act) are available
for operating the system, in addition to
availability for such other purposes as may
be authorized for the use of the fees.
(B) A provision that the Secretary may
deny such chimpanzee acceptance into the
system if the capacity of the system is not
sufficient to accept the chimpanzee, taking
into account the physical capacity of the
system; the financial resources of the system; the number of individuals serving as
the staff of the system, including the number of professional staff; the necessity of
providing for the safety of the staff and of
the public; the necessity of caring for accepted chimpanzees in accordance with the
standards under paragraph (1); and such
other factors as may be appropriate.
(C) A provision that the Secretary may
deny such chimpanzee acceptance into the
system if a complete history of the health
and use in research of the chimpanzee is not
available to the Secretary.
(D) Such additional standards as the Secretary determines to be appropriate.
(e) Award of contract for operation of system
(1) In general
Subject to the availability of funds pursuant
to subsection (g) of this section, the Secretary
shall make an award of a contract to a nonprofit private entity under which the entity
has the responsibility of operating (and establishing, as applicable) the sanctuary system
and awarding subcontracts or grants to individual sanctuary facilities that meet the
standards under subsection (d) of this section.
(2) Requirements
The Secretary may make an award under
paragraph (1) to a nonprofit private entity
only if the entity meets the following requirements:
(A) The entity has a governing board of directors that is composed and appointed in
accordance with paragraph (3) and is satisfactory to the Secretary.
(B) The terms of service for members of
such board are in accordance with paragraph
(3).
(C) The members of the board serve without compensation. The members may be reimbursed for travel, subsistence, and other
necessary expenses incurred in carrying out
the duties of the board.
(D) The entity has an executive director
meeting such requirements as the Secretary
determines to be appropriate.
(E) The entity makes the agreement described in paragraph (4) (relating to nonFederal contributions).
(F) The entity agrees to comply with
standards under subsection (d) of this section.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a reasonable basis to persons who conduct biomedical or behavioral
research, with priority given to such persons
who are Federal employees or who receive financial support from the Federal Government for research.
(H) Such other requirements as the Secretary determines to be appropriate.
(3) Board of directors
For purposes of subparagraphs (A) and (B) of
paragraph (2):
(A) The governing board of directors of the
nonprofit private entity involved is composed and appointed in accordance with this
paragraph if the following conditions are
met:
(i) Such board is composed of not more
than 13 voting members.
(ii) Such members include individuals
with expertise and experience in the
science of managing captive chimpanzees
(including primate veterinary care), appointed from among individuals endorsed
by organizations that represent individuals in such field.
(iii) Such members include individuals
with expertise and experience in the field
of animal protection, appointed from
among individuals endorsed by organizations that represent individuals in such
field.
(iv) Such members include individuals
with expertise and experience in the zoological field (including behavioral primatology), appointed from among individuals
endorsed by organizations that represent
individuals in such field.
(v) Such members include individuals
with expertise and experience in the field
of the business and management of nonprofit
organizations,
appointed
from
among individuals endorsed by organizations that represent individuals in such
field.
(vi) Such members include representatives from entities that provide accreditation in the field of laboratory animal medicine.
(vii) Such members include individuals
with expertise and experience in the field
of containing biohazards.
(viii) Such members include an additional member who serves as the chair of
the board, appointed from among individuals who have been endorsed for purposes
of clause (ii), (iii), (iv), or (v).
(ix) None of the members of the board
has been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [7 U.S.C. 2131 et seq.].
(B) The terms of service for members of
the board of directors are in accordance with
this paragraph if the following conditions
are met:
(i) The term of the chair of the board is
3 years.
(ii) The initial members of the board select, by a random method, one member

§ 287a–3a

from each of the six fields specified in subparagraph (A) to serve a term of 2 years
and (in addition to the chair) one member
from each of such fields to serve a term of
3 years.
(iii) After the initial terms under clause
(ii) expire, each member of the board
(other than the chair) is appointed to serve
a term of 2 years.
(iv) An individual whose term of service
expires may be reappointed to the board.
(v) A vacancy in the membership of the
board is filled in the manner in which the
original appointment was made.
(vi) If a member of the board does not
serve the full term applicable to the member, the individual appointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor
member.
(4) Requirement of matching funds
The agreement required in paragraph (2)(E)
for a nonprofit private entity (relating to the
award of the contract under paragraph (1)) is
an agreement that, with respect to the costs
to be incurred by the entity in establishing
and operating the sanctuary system, the entity will make available (directly or through
donations from public or private entities) nonFederal contributions toward such costs, in
cash or in kind, in an amount not less than
the following, as applicable:
(A) For expenses associated with establishing the sanctuary system (as determined by
the Secretary), 10 percent of such costs ($1
for each $9 of Federal funds provided under
the contract under paragraph (1)).
(B) For expenses associated with operating
the sanctuary system (as determined by the
Secretary), 25 percent of such costs ($1 for
each $3 of Federal funds provided under such
contract).
(5) Establishment of contract entity
If the Secretary determines that an entity
meeting the requirements of paragraph (2)
does not exist, not later than 60 days after December 20, 2000, the Secretary shall, for purposes of paragraph (1), make a grant for the establishment of such an entity, including paying the cost of incorporating the entity under
the law of one of the States.
(f) Definitions
For purposes of this section:
(1) Permanent retirement
The term ‘‘permanent retirement’’, with respect to a chimpanzee that has been accepted
into the sanctuary system, means that under
subsection (a) of this section the system provides for the lifetime care of the chimpanzee,
that under subsection (d)(2) of this section the
system does not permit the chimpanzee to be
used in research (except as authorized under
subsection (d)(3) of this section) or to be
euthanized (except as provided in subsection
(d)(2)(I) of this section), that under subsection
(d)(2) of this section the system will not discharge the chimpanzee from the system, and
that under such subsection the system otherwise cares for the chimpanzee.

§ 287a–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Sanctuary system
The term ‘‘sanctuary system’’ means the
system described in subsection (a) of this section.
(3) Secretary
The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(4) Surplus chimpanzees
The term ‘‘surplus chimpanzees’’ has the
meaning given that term in subsection (a) of
this section.
(g) Funding
(1) In general
Of the amount appropriated under this chapter for fiscal year 2001 and each subsequent fiscal year, the Secretary, subject to paragraph
(2), shall reserve a portion for purposes of the
operation (and establishment, as applicable) of
the sanctuary system and for purposes of paragraph (3), except that the Secretary may not
for such purposes reserve any further funds
from such amount after the aggregate total of
the funds so reserved for such fiscal years
reaches $30,000,000. The purposes for which
funds reserved under the preceding sentence
may be expended include the construction and
renovation of facilities for the sanctuary system.
(2) Limitation
Funds may not be reserved for a fiscal year
under paragraph (1) unless the amount appropriated under this chapter for such year equals
or exceeds the amount appropriated under this
chapter for fiscal year 1999.
(3) Use of funds for other compliant facilities
With respect to amounts reserved under
paragraph (1) for a fiscal year, the Secretary
may use a portion of such amounts to make
awards of grants or contracts to public or private entities operating facilities that, as determined by the board of directors of the nonprofit private entity that receives the contract under subsection (e) of this section, provide for the retirement of chimpanzees in accordance with the same standards that apply
to the sanctuary system pursuant to regulations under subsection (d) of this section. Such
an award may be expended for the expenses of
operating the facilities involved.
(July 1, 1944, ch. 373, title IV, § 481C, as added
Pub. L. 106–551, § 2, Dec. 20, 2000, 114 Stat. 2752;
amended Pub. L. 110–170, § 2(a), Dec. 26, 2007, 121
Stat. 2465.)
REFERENCES IN TEXT
The Animal Welfare Act, referred to in subsecs.
(d)(2)(D), (3)(B) and (e)(3)(A)(ix), is Pub. L. 89–544, Aug.
24, 1966, 80 Stat. 350, as amended, which is classified
generally to chapter 54 (§ 2131 et seq.) of Title 7, Agriculture. For complete classification of this Act to the
Code, see Short Title note set out under section 2131 of
Title 7 and Tables.
Section 3 of the Chimpanzee Health Improvement,
Maintenance, and Protection Act, referred to in subsec.
(d)(4)(A), is section 3 of Pub. L. 106–551, which is set out
as a note below.
PRIOR PROVISIONS
A prior section 481C of act July 1, 1944, was renumbered section 481D and is classified to section 287a–4 of
this title.

Page 614

AMENDMENTS
2007—Subsec. (d)(2)(J). Pub. L. 110–170, § 2(a)(1), struck
out at end ‘‘If any chimpanzee is removed from a sanctuary facility for purposes of research authorized under
paragraph (3)(A)(ii), the chimpanzee shall be returned
immediately upon the completion of that research. All
costs associated with the removal of the chimpanzee
from the facility, with the care of the chimpanzee during such absence from the facility, and with the return
of the chimpanzee to the facility shall be the responsibility of the entity that obtains approval under such
paragraph regarding use of the chimpanzee and removes the chimpanzee from the sanctuary facility.’’
Subsec. (d)(3)(A). Pub. L. 110–170, § 2(a)(2)(A), substituted ‘‘except that the chimpanzee may be used for
noninvasive behavioral studies’’ for ‘‘except as provided
in clause (i) or (ii), as follows:
‘‘(i) The chimpanzee may be used for noninvasive
behavioral studies’’
and struck out cl. (ii) which related to findings necessary before a chimpanzee may be used in research.
Subsec. (d)(3)(B), (C). Pub. L. 110–170, § 2(a)(2)(B)–(D),
redesignated subpar. (C) as (B), substituted ‘‘under subparagraph (A)’’ for ‘‘under subparagraphs (A) and (B)’’,
and struck out former subpar. (B) which related to approval of research design.
REPORT TO CONGRESS REGARDING NUMBER OF
CHIMPANZEES AND FUNDING FOR CARE OF CHIMPANZEES
Pub. L. 106–551, § 3, Dec. 20, 2000, 114 Stat. 2759, provided that:
‘‘With respect to chimpanzees that have been used, or
were bred or purchased for use, in research conducted
or supported by the National Institutes of Health, the
Food and Drug Administration, or other agencies of the
Federal Government, the Secretary of Health and
Human Services shall, not later than 365 days after the
date of the enactment of this Act [Dec. 20, 2000], submit
to Congress a report providing the following information:
‘‘(1) The number of such chimpanzees in the United
States, whether owned or held by the Federal Government, any of the States, or private entities.
‘‘(2) An identification of any requirement imposed
by the Federal Government that, as a condition of
the use of such a chimpanzee in research by a nonFederal entity—
‘‘(A) fees be paid by the entity to the Federal
Government for the purpose of providing for the
care of the chimpanzee (including any fees for longterm care); or
‘‘(B) funds be provided by the entity to a State,
unit of local government, or private entity for an
endowment or other financial account whose purpose is to provide for the care of the chimpanzee
(including any funds provided for long-term care).
‘‘(3) An accounting for fiscal years 1999 and 2000 of
all fees paid and funds provided by non-Federal entities pursuant to requirements described in subparagraphs (A) and (B) of paragraph (2).
‘‘(4) In the case of such fees, a specification of
whether the fees were available to the Secretary (or
other Federal officials) pursuant to annual appropriations Acts or pursuant to permanent appropriations.’’

§ 287a–4. General clinical research centers
(a) Grants
The Director of the National Center for Research Resources shall award grants for the establishment of general clinical research centers
to provide the infrastructure for clinical research including clinical research training and
career enhancement. Such centers shall support
clinical studies and career development in all
settings of the hospital or academic medical
center involved.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Activities
In carrying out subsection (a) of this section,
the Director of National Institutes of Health
shall expand the activities of the general clinical research centers through the increased use
of telecommunications and telemedicine initiatives.
(July 1, 1944, ch. 373, title IV, § 481D, formerly
§ 481C, as added Pub. L. 106–505, title II, § 204(a),
Nov. 13, 2000, 114 Stat. 2327; amended Pub. L.
109–482, title I, § 103(b)(42), Jan. 15, 2007, 120 Stat.
3688; renumbered § 481D, Pub. L. 110–170, § 2(b),
Dec. 26, 2007, 121 Stat. 2466.)
AMENDMENTS
2007—Subsec. (c). Pub. L. 109–482 struck out heading
and text of subsec. (c). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each fiscal year.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 2—JOHN E. FOGARTY INTERNATIONAL
CENTER FOR ADVANCED STUDY IN HEALTH SCIENCES

§ 287b. General purpose
The general purpose of the John E. Fogarty
International Center for Advanced Study in the
Health Sciences is to—
(1) facilitate the assembly of scientists and
others in the biomedical, behavioral, and related fields for discussion, study, and research
relating to the development of health science
internationally;
(2) provide research programs, conferences,
and seminars to further international cooperation and collaboration in the life sciences;
(3) provide postdoctorate fellowships for research training in the United States and
abroad and promote exchanges of senior scientists between the United States and other
countries;
(4) coordinate the activities of the National
Institutes of Health concerned with the health
sciences internationally; and
(5) receive foreign visitors to the National
Institutes of Health.
(July 1, 1944, ch. 373, title IV, § 482, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 866.)
SUBPART 3—NATIONAL CENTER FOR HUMAN
GENOME RESEARCH

CODIFICATION
Subpart 3 of part E of title IV of act July 1, 1944, comprising this subpart, was renumbered subpart 19 of part
C of title IV by Pub. L. 109–482, title I, § 101(c)(1)–(3),
Jan. 15, 2007, 120 Stat. 3681, and is classified to subpart
19 (§ 285s) of part C of this subchapter.

§ 287c. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title IV, § 485B, as
added Pub. L. 103–43, title XV, § 1521(2), June 10, 1993, 107
Stat. 180, which set out the purpose of the National

§ 287c–11

Center for Human Genome Research, was renumbered
section 464z–1 of act July 1, 1944, by Pub. L. 109–482,
title I, § 101(c)(4)(A), Jan. 15, 2007, 120 Stat. 3681, and
transferred to section 285s of this title.
PRIOR PROVISIONS
Another prior section 287c, act July 1, 1944, ch. 373,
title IV, § 483, as added Nov. 20, 1985, Pub. L. 99–158, § 2,
99 Stat. 867, and amended, which related to purpose of
National Center for Nursing Research, was renumbered
section 464V of act July 1, 1944, by Pub. L. 103–43, title
XV, § 1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q of this title.
A prior section 287c–1, act July 1, 1944, ch. 373, title
IV, § 484, as added Nov. 20, 1985, Pub. L. 99–158, § 2, 99
Stat. 867, and amended, which related to specific authorities of the Director of the Center, was renumbered
section 464W of act July 1, 1944, by Pub. L. 103–43, title
XV, § 1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q–1 of this title.
A prior section 287c–2, act July 1, 1944, ch. 373, title
IV, § 485, as added Nov. 20, 1985, Pub. L. 99–158, § 2, 99
Stat. 867, and amended, which related to the advisory
council for the Center, was renumbered section 464X of
act July 1, 1944, by Pub. L. 103–43, title XV, § 1511(b)(2),
June 10, 1993, 107 Stat. 179, and transferred to section
285q–2 of this title.
A prior section 287c–3, act July 1, 1944, ch. 373, title
IV, § 486, as added Nov. 20, 1985, Pub. L. 99–158, § 2, 99
Stat. 869, and amended, which related to biennial report of activities of the Center, was renumbered section
464Y of act July 1, 1944, by Pub. L. 103–43, title XV,
§ 1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred
to section 285q–3 of this title.
SUBPART 4—OFFICE OF DIETARY SUPPLEMENTS

§ 287c–11. Dietary supplements
(a) Establishment
The Secretary shall establish an Office of Dietary Supplements within the National Institutes of Health.
(b) Purpose
The purposes of the Office are—
(1) to explore more fully the potential role of
dietary supplements as a significant part of
the efforts of the United States to improve
health care; and
(2) to promote scientific study of the benefits of dietary supplements in maintaining
health and preventing chronic disease and
other health-related conditions.
(c) Duties
The Director of the Office of Dietary Supplements shall—
(1) conduct and coordinate scientific research within the National Institutes of
Health relating to dietary supplements and
the extent to which the use of dietary supplements can limit or reduce the risk of diseases
such as heart disease, cancer, birth defects,
osteoporosis, cataracts, or prostatism;
(2) collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign
sources or the Office of Alternative Medicine;
(3) serve as the principal advisor to the Secretary and to the Assistant Secretary for
Health and provide advice to the Director of
the National Institutes of Health, the Director
of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs
on issues relating to dietary supplements including—

§ 287c–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) dietary intake regulations;
(B) the safety of dietary supplements;
(C) claims characterizing the relationship
between—
(i) dietary supplements; and
(ii)(I) prevention of disease or other
health-related conditions; and
(II) maintenance of health; and
(D) scientific issues arising in connection
with the labeling and composition of dietary
supplements;
(4) compile a database of scientific research
on dietary supplements and individual nutrients; and
(5) coordinate funding relating to dietary
supplements for the National Institutes of
Health.
(d) ‘‘Dietary supplement’’ defined
As used in this section, the term ‘‘dietary supplement’’ has the meaning given the term in
section 321(ff) of title 21.
(July 1, 1944, ch. 373, title IV, § 485C, as added
Pub. L. 103–417, § 13(a), Oct. 25, 1994, 108 Stat.
4334; amended Pub. L. 109–482, title I, § 103(b)(43),
Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘There are
authorized to be appropriated to carry out this section
$5,000,000 for fiscal year 1994 and such sums as may be
necessary for each subsequent fiscal year.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART 5—NATIONAL CENTER FOR
COMPLEMENTARY AND ALTERNATIVE MEDICINE

§ 287c–21. Purpose of Center
(a) In general
The general purposes of the National Center
for Complementary and Alternative Medicine
(in this subpart referred to as the ‘‘Center’’) are
the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating,
and validating complementary and alternative
treatment, diagnostic and prevention modalities, disciplines and systems. The Center shall
be headed by a director, who shall be appointed
by the Secretary. The Director of the Center
shall report directly to the Director of NIH.
(b) Advisory council
The Secretary shall establish an advisory
council for the Center in accordance with section 284a of this title, except that at least half
of the members of the advisory council who are
not ex officio members shall include practitioners licensed in one or more of the major systems
with which the Center is concerned, and at least
3 individuals representing the interests of individual consumers of complementary and alternative medicine.

Page 616

(c) Complement to conventional medicine
In carrying out subsection (a) of this section,
the Director of the Center shall, as appropriate,
study the integration of alternative treatment,
diagnostic and prevention systems, modalities,
and disciplines with the practice of conventional
medicine as a complement to such medicine and
into health care delivery systems in the United
States.
(d) Appropriate scientific expertise and coordination with institutes and Federal agencies
The Director of the Center, after consultation
with the advisory council for the Center and the
division of research grants, shall ensure that
scientists with appropriate expertise in research
on complementary and alternative medicine are
incorporated into the review, oversight, and
management processes of all research projects
and other activities funded by the Center. In
carrying out this subsection, the Director of the
Center, as necessary, may establish review
groups with appropriate scientific expertise. The
Director of the Center shall coordinate efforts
with other Institutes and Federal agencies to
ensure appropriate scientific input and management.
(e) Evaluation of various disciplines and systems
In carrying out subsection (a) of this section,
the Director of the Center shall identify and
evaluate alternative and complementary medical treatment, diagnostic and prevention modalities in each of the disciplines and systems with
which the Center is concerned, including each
discipline and system in which accreditation,
national certification, or a State license is
available.
(f) Ensuring high quality, rigorous scientific review
In order to ensure high quality, rigorous scientific review of complementary and alternative, diagnostic and prevention modalities,
disciplines and systems, the Director of the Center shall conduct or support the following activities:
(1) Outcomes research and investigations.
(2) Epidemiological studies.
(3) Health services research.
(4) Basic science research.
(5) Clinical trials.
(6) Other appropriate research and investigational activities.
The Director of NIH, in coordination with the
Director of the Center, shall designate specific
personnel in each Institute to serve as full-time
liaisons with the Center in facilitating appropriate coordination and scientific input.
(g) Data system; information clearinghouse
(1) Data system
The Director of the Center shall establish a
bibliographic system for the collection, storage, and retrieval of worldwide research relating to complementary and alternative treatment, diagnostic and prevention modalities,
disciplines and systems. Such a system shall
be regularly updated and publicly accessible.
(2) Clearinghouse
The Director of the Center shall establish an
information clearinghouse to facilitate and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

enhance, through the effective dissemination
of information, knowledge and understanding
of alternative medical treatment, diagnostic
and prevention practices by health professionals, patients, industry, and the public.
(h) Research centers
The Director of the Center, after consultation
with the advisory council for the Center, shall
provide support for the development and operation of multipurpose centers to conduct research and other activities described in subsection (a) of this section with respect to complementary and alternative treatment, diagnostic and prevention modalities, disciplines
and systems. The provision of support for the development and operation of such centers shall
include accredited complementary and alternative medicine research and education facilities.
(i) Availability of resources
After consultation with the Director of the
Center, the Director of NIH shall ensure that resources of the National Institutes of Health, including laboratory and clinical facilities, fellowships (including research training fellowship and
junior and senior clinical fellowships), and other
resources are sufficiently available to enable the
Center to appropriately and effectively carry
out its duties as described in subsection (a) of
this section. The Director of NIH, in coordination with the Director of the Center, shall designate specific personnel in each Institute to
serve as full-time liaisons with the Center in facilitating appropriate coordination and scientific input.
(j) Availability of appropriations
Amounts appropriated to carry out this section for fiscal year 1999 are available for obligation through September 30, 2001. Amounts appropriated to carry out this section for fiscal year
2000 are available for obligation through September 30, 2001.
(July 1, 1944, ch. 373, title IV, § 485D, as added
Pub. L. 105–277, div. A, § 101(f) [title VI, § 601(2)],
Oct. 21, 1998, 112 Stat. 2681–337, 2681–387.)
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
EXECUTIVE ORDER NO. 13147
Ex. Ord. No. 13147, Mar. 7, 2000, 65 F.R. 13233, as
amended by Ex. Ord. No. 13167, Sept. 15, 2000, 65 F.R.
54079 [57079], 65 F.R. 57436, which established White
House Commission on Complementary and Alternative

§ 287d

Medicine Policy, was revoked by Ex. Ord. No. 13316,
§ 3(i), Sept. 17, 2003, 68 F.R. 55256, eff. Sept. 30, 2003.
SUBPART 6—TRANSFERRED

CODIFICATION
Subpart 6 of part E of title IV of act July 1, 1944, comprising this subpart, was renumbered subpart 20 of part
C of title IV by Pub. L. 111–148, title X,
§ 10334(c)(1)(A)–(C), Mar. 23, 2010, 124 Stat. 973, and is
classified to subpart 20 (§ 285t et seq.) of part C of this
subchapter.

§§ 287c–31 to 287c–34. Transferred
CODIFICATION
Section 287c–31, act July 1, 1944, ch. 373, title IV,
§ 485E, as added Pub. L. 106–525, title I, § 101(a), Nov. 22,
2000, 114 Stat. 2497; amended Pub. L. 109–482, title I,
§§ 103(b)(44), 104(b)(1)(N), Jan. 15, 2007, 120 Stat. 3688,
3693, which set out the purpose of the National Center
on Minority Health and Health Disparities, was renumbered section 464z–3 of act July 1, 1944, and transferred
to section 285t of this title.
Section 287c–32, act July 1, 1944, ch. 373, title IV,
§ 485F, as added Pub. L. 106–525, title I, § 102, Nov. 22,
2000, 114 Stat. 2501; amended Pub. L. 109–482, title I,
§ 103(b)(45), Jan. 15, 2007, 120 Stat. 3688, which related to
centers of excellence for research education and training, was renumbered section 464z–4 of act July 1, 1944,
and transferred to section 285t–1 of this title.
Section 287c–33, act July 1, 1944, ch. 373, title IV,
§ 485G, as added Pub. L. 106–525, title I, § 103, Nov. 22,
2000, 114 Stat. 2503; amended Pub. L. 109–482, title I,
§ 103(b)(46), Jan. 15, 2007, 120 Stat. 3688, which related to
loan repayment program for minority health disparities research, was renumbered section 464z–5 of act July
1, 1944, and transferred to section 285t–2 of this title.
Section 287c–34, act July 1, 1944, ch. 373, title IV,
§ 485H, as added Pub. L. 106–525, title I, § 104, Nov. 22,
2000, 114 Stat. 2503; amended Pub. L. 109–482, title I,
§ 104(b)(1)(O), Jan. 15, 2007, 120 Stat. 3693, which related
to administrative support and support services, was renumbered section 464z–6 of act July 1, 1944, and transferred to section 285t–3 of this title.

PART F—RESEARCH ON WOMEN’S HEALTH
§ 287d. Office of Research on Women’s Health
(a) Establishment
There is established within the Office of the
Director of NIH an office to be known as the Office of Research on Women’s Health (in this part
referred to as the ‘‘Office’’). The Office shall be
headed by a director, who shall be appointed by
the Director of NIH and who shall report directly to the Director.
(b) Purpose
The Director of the Office shall—
(1) identify projects of research on women’s
health that should be conducted or supported
by the national research institutes;
(2) identify multidisciplinary research relating to research on women’s health that should
be so conducted or supported;
(3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause;
(4) promote coordination and collaboration
among entities conducting research identified
under any of paragraphs (1) through (3);
(5) encourage the conduct of such research
by entities receiving funds from the national
research institutes;

§ 287d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) recommend an agenda for conducting and
supporting such research;
(7) promote the sufficient allocation of the
resources of the national research institutes
for conducting and supporting such research;
(8) assist in the administration of section
289a–2 of this title with respect to the inclusion of women as subjects in clinical research;
and
(9) prepare the report required in section
287d–2 of this title.
(c) Coordinating Committee
(1) In carrying out subsection (b) of this section, the Director of the Office shall establish a
committee to be known as the Coordinating
Committee on Research on Women’s Health (in
this subsection referred to as the ‘‘Coordinating
Committee’’).
(2) The Coordinating Committee shall be composed of the Directors of the national research
institutes (or the designees of the Directors).
(3) The Director of the Office shall serve as the
chair of the Coordinating Committee.
(4) With respect to research on women’s
health, the Coordinating Committee shall assist
the Director of the Office in—
(A) identifying the need for such research,
and making an estimate each fiscal year of the
funds needed to adequately support the research;
(B) identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities;
(C) supporting the development of methodologies to determine the circumstances in
which obtaining data specific to women (including data relating to the age of women and
the membership of women in ethnic or racial
groups) is an appropriate function of clinical
trials of treatments and therapies;
(D) supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been
determined to be an appropriate function; and
(E) encouraging the national research institutes to conduct and support such research,
including such clinical trials.
(d) Advisory Committee
(1) In carrying out subsection (b) of this section, the Director of the Office shall establish an
advisory committee to be known as the Advisory Committee on Research on Women’s Health
(in this subsection referred to as the ‘‘Advisory
Committee’’).
(2) The Advisory Committee shall be composed
of no fewer than 12, and not more than 18 individuals, who are not officers or employees of the
Federal Government. The Director of NIH shall
make appointments to the Advisory Committee
from among physicians, practitioners, scientists, and other health professionals, whose
clinical practice, research specialization, or professional expertise includes a significant focus
on research on women’s health. A majority of
the members of the Advisory Committee shall
be women.
(3) The Director of the Office shall serve as the
chair of the Advisory Committee.
(4) The Advisory Committee shall—

Page 618

(A) advise the Director of the Office on appropriate research activities to be undertaken
by the national research institutes with respect to—
(i) research on women’s health;
(ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
(iii) research on gender differences in disease etiology, course, and treatment;
(iv) research on obstetrical and gynecological health conditions, diseases, and
treatments; and
(v) research on women’s health conditions
which require a multidisciplinary approach;
(B) report to the Director of the Office on
such research;
(C) provide recommendations to such Director regarding activities of the Office (including recommendations on the development of
the methodologies described in subsection
(c)(4)(C) of this section and recommendations
on priorities in carrying out research described in subparagraph (A)); and
(D) assist in monitoring compliance with
section 289a–2 of this title regarding the inclusion of women in clinical research.
(5)(A) The Advisory Committee shall prepare a
biennial report describing the activities of the
Committee, including findings made by the
Committee regarding—
(i) compliance with section 289a–2 of this
title;
(ii) the extent of expenditures made for research on women’s health by the agencies of
the National Institutes of Health; and
(iii) the level of funding needed for such research.
(B) The report required in subparagraph (A)
shall be submitted to the Director of NIH for inclusion in the report required in section 283 of
this title.
(e) Representation of women among researchers
The Secretary, acting through the Assistant
Secretary for Personnel and in collaboration
with the Director of the Office, shall determine
the extent to which women are represented
among senior physicians and scientists of the
national research institutes and among physicians and scientists conducting research with
funds provided by such institutes, and as appropriate, carry out activities to increase the extent of such representation.
(f) Definitions
For purposes of this part:
(1) The term ‘‘women’s health conditions’’,
with respect to women of all age, ethnic, and
racial groups, means all diseases, disorders,
and conditions (including with respect to mental health)—
(A) unique to, more serious, or more prevalent in women;
(B) for which the factors of medical risk or
types of medical intervention are different
for women, or for which it is unknown
whether such factors or types are different
for women; or
(C) with respect to which there has been
insufficient clinical research involving

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

women as subjects or insufficient clinical
data on women.
(2) The term ‘‘research on women’s health’’
means research on women’s health conditions,
including research on preventing such conditions.
(July 1, 1944, ch. 373, title IV, § 486, as added Pub.
L. 103–43, title I, § 141(a)(3), June 10, 1993, 107
Stat. 136; amended Pub. L. 105–340, title I, § 106,
Oct. 31, 1998, 112 Stat. 3193; Pub. L. 111–148, title
III, § 3509(c), Mar. 23, 2010, 124 Stat. 534.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148 inserted ‘‘and who
shall report directly to the Director’’ before period at
end.
1998—Subsec. (d)(2). Pub. L. 105–340 substituted ‘‘NIH’’
for ‘‘the Office’’.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by Congress, its duration is
otherwise provided for by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 287d–1. National data system and clearinghouse
on research on women’s health
(a) Data system
(1) The Director of NIH, in consultation with
the Director of the Office and the Director of the
National Library of Medicine, shall establish a
data system for the collection, storage, analysis,
retrieval, and dissemination of information regarding research on women’s health that is conducted or supported by the national research institutes. Information from the data system shall
be available through information systems available to health care professionals and providers,
researchers, and members of the public.
(2) The data system established under paragraph (1) shall include a registry of clinical
trials of experimental treatments that have
been developed for research on women’s health.
Such registry shall include information on subject eligibility criteria, sex, age, ethnicity or
race, and the location of the trial site or sites.
Principal investigators of such clinical trials
shall provide this information to the registry
within 30 days after it is available. Once a trial
has been completed, the principal investigator
shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the
experimental treatment or treatments evaluated.
(b) Clearinghouse
The Director of NIH, in consultation with the
Director of the Office and with the National Li-

§ 288

brary of Medicine, shall establish, maintain, and
operate a program to provide information on research and prevention activities of the national
research institutes that relate to research on
women’s health.
(July 1, 1944, ch. 373, title IV, § 486A, as added
Pub. L. 103–43, title I, § 141(a)(3), June 10, 1993, 107
Stat. 138.)
§ 287d–2. Biennial report
(a) In general
With respect to research on women’s health,
the Director of the Office shall, not later than
February 1, 1994, and biennially thereafter, prepare a report—
(1) describing and evaluating the progress
made during the preceding 2 fiscal years in research and treatment conducted or supported
by the National Institutes of Health;
(2) describing and analyzing the professional
status of women physicians and scientists of
such Institutes, including the identification of
problems and barriers regarding advancements;
(3) summarizing and analyzing expenditures
made by the agencies of such Institutes (and
by such Office) during the preceding 2 fiscal
years; and
(4) making such recommendations for legislative and administrative initiatives as the Director of the Office determines to be appropriate.
(b) Inclusion in biennial report of Director of
NIH
The Director of the Office shall submit each
report prepared under subsection (a) of this section to the Director of NIH for inclusion in the
report submitted to the President and the Congress under section 283 of this title.
(July 1, 1944, ch. 373, title IV, § 486B, as added
Pub. L. 103–43, title I, § 141(a)(3), June 10, 1993, 107
Stat. 139.)
PART G—AWARDS AND TRAINING
AMENDMENTS
1993—Pub. L. 103–43, title I, § 141(a)(2), June 10, 1993,
107 Stat. 136, redesignated part F ‘‘Awards and Training’’ as G. Former part G ‘‘General Provisions’’ redesignated H.

§ 288. Ruth L. Kirschstein National Research
Service Awards
(a) Biomedical and behavioral research and research training; programs and institutions
included; restriction; special consideration
(1) The Secretary shall—
(A) provide Ruth L. Kirschstein National Research Service Awards for—
(i) biomedical and behavioral research at
the National Institutes of Health in matters
relating to the cause, diagnosis, prevention,
and treatment of the diseases or other
health problems to which the activities of
the National Institutes of Health and Administration 1 are directed;
1 So in original. Reference to Administration probably should
not appear.

§ 288

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) training at the National Institutes of
Health and at the Administration 1 of individuals to undertake such research;
(iii) biomedical and behavioral research
and health services research (including research in primary medical care) at public
and nonprofit private entities; and
(iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake biomedical and behavioral research;
(B) make grants to public and nonprofit private institutions to enable such institutions
to make Ruth L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and behavioral
research) in the matters described in subparagraph (A)(i) to individuals selected by such institutions; and
(C) provide contracts for scholarships and
loan repayments in accordance with sections
288–4 and 288–5 of this title, subject to providing not more than an aggregate 50 such contracts during the fiscal years 1994 through
1996.
A reference in this subsection to the National
Institutes of Health shall be considered to include the institutes, agencies, divisions, and bureaus included in the National Institutes of
Health or under the Administration,1 as the case
may be.
(2) Ruth L. Kirschstein National Research
Service Awards may not be used to support residency training of physicians and other health
professionals.
(3) In awarding Ruth L. Kirschstein National
Research Service Awards under this section, the
Secretary shall take account of the Nation’s
overall need for biomedical research personnel
by giving special consideration to physicians
who agree to undertake a minimum of two years
of biomedical research.
(4) The Secretary shall carry out paragraph (1)
in a manner that will result in the recruitment
of women, and individuals from disadvantaged
backgrounds (including racial and ethnic minorities), into fields of biomedical or behavioral
research and in the provision of research training to women and such individuals.
(b) Prerequisites for Award; review and approval
by appropriate advisory councils; Award period; uses for Award; payments to non-Federal public or nonprofit private institutions
(1) No Ruth L. Kirschstein National Research
Service Award may be made by the Secretary to
any individual unless—
(A) the individual has submitted to the Secretary an application therefor and the Secretary has approved the application;
(B) the individual provides, in such form and
manner as the Secretary shall by regulation
prescribe, assurances satisfactory to the Secretary that the individual will meet the service requirement of subsection (c) of this section; and
(C) in the case of a Ruth L. Kirschstein National Research Service Award for a purpose
described in subsection (a)(1)(A)(iii) of this
section, the individual has been sponsored (in

Page 620

such manner as the Secretary may by regulation require) by the institution at which the
research or training under the award will be
conducted.
An application for an award shall be in such
form, submitted in such manner, and contain
such information, as the Secretary may by regulation prescribe.
(2) The making of grants under subsection
(a)(1)(B) of this section for Ruth L. Kirschstein
National Research Service Awards shall be subject to review and approval by the appropriate
advisory councils within the Department of
Health and Human Services (A) whose activities
relate to the research or training under the
awards, or (B) for the entity at which such research or training will be conducted.
(3) No grant may be made under subsection
(a)(1)(B) of this section unless an application
therefor has been submitted to and approved by
the Secretary. Such application shall be in such
form, submitted in such manner, and contain
such information, as the Secretary may by regulation prescribe. Subject to the provisions of
this section (other than paragraph (1)), Ruth L.
Kirschstein National Research Service Awards
made under a grant under subsection (a)(1)(B) of
this section shall be made in accordance with
such regulations as the Secretary shall prescribe.
(4) The period of any Ruth L. Kirschstein National Research Service Award made to any individual under subsection (a) of this section may
not exceed—
(A) five years in the aggregate for pre-doctoral training; and
(B) three years in the aggregate for post-doctoral training;
unless the Secretary for good cause shown
waives the application of such limit to such individual.
(5) Ruth L. Kirschstein National Research
Service Awards shall provide for such stipends,
tuition, fees, and allowances (including travel
and subsistence expenses and dependency allowances), adjusted periodically to reflect increases
in the cost of living, for the recipients of the
awards as the Secretary may deem necessary. A
Ruth L. Kirschstein National Research Service
Award made to an individual for research or research training at a non-Federal public or nonprofit private institution shall also provide for
payments to be made to the institution for the
cost of support services (including the cost of
faculty salaries, supplies, equipment, general research support, and related items) provided such
individual by such institution. The amount of
any such payments to any institution shall be
determined by the Secretary and shall bear a direct relationship to the reasonable costs of the
institution for establishing and maintaining the
quality of its biomedical and behavioral research and training programs.
(c) Health research or teaching; service period;
recovery upon noncompliance with service
requirement, formula; cancellation or waiver
of obligation
(1) Each individual who is awarded a Ruth L.
Kirschstein National Research Service Award

Page 621

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for postdoctoral research training shall, in accordance with paragraph (3), engage in research
training, research, or teaching that is health-related (or any combination thereof) for the period
specified in paragraph (2). Such period shall be
served in accordance with the usual patterns of
scientific employment.
(2)(A) The period referred to in paragraph (1) is
12 months, or one month for each month for
which the individual involved receives a Ruth L.
Kirschstein National Research Service Award
for postdoctoral research training, whichever is
less.
(B) With respect to postdoctoral research
training, in any case in which an individual receives a Ruth L. Kirschstein National Research
Service Award for more than 12 months, the 13th
month and each subsequent month of performing activities under the Award shall be considered to be activities engaged in toward satisfaction of the requirement established in paragraph
(1) regarding a period of service.
(3) The requirement of paragraph (1) shall be
complied with by any individual to whom it applies within such reasonable period of time,
after the completion of such individual’s award,
as the Secretary shall by regulation prescribe.
The Secretary shall by regulation prescribe the
type of research and teaching in which an individual may engage to comply with such requirement and such other requirements respecting research and teaching as the Secretary considers
appropriate.
(4)(A) If any individual to whom the requirement of paragraph (1) is applicable fails, within
the period prescribed by paragraph (3), to comply with such requirements, the United States
shall be entitled to recover from such individual
an amount determined in accordance with the
formula—
t¥s
A=φ +——,
t
in which ‘‘A’’ is the amount the United States is
entitled to recover; ‘‘φ’’ is the sum of the total
amount paid under one or more Ruth L.
Kirschstein National Research Service Awards
to such individual; ‘‘t’’ is the total number of
months in such individual’s service obligation;
and ‘‘s’’ is the number of months of such obligation served by such individual in accordance
with paragraphs (1) and (2) of this subsection.
(B) Any amount which the United States is entitled to recover under subparagraph (A) shall,
within the three-year period beginning on the
date the United States becomes entitled to recover such amount, be paid to the United States.
Until any amount due the United States under
subparagraph (A) on account of any Ruth L.
Kirschstein National Research Service Award is
paid, there shall accrue to the United States interest on such amount at a rate fixed by the
Secretary of the Treasury after taking into consideration private consumer rates of interest
prevailing on the date the United States becomes entitled to such amount.
(5)(A) Any obligation of an individual under
paragraph (1) shall be canceled upon the death of
such individual.
(B) The Secretary shall by regulation provide
for the waiver or suspension of any such obliga-

§ 288

tion applicable to any individual whenever compliance by such individual is impossible or
would involve substantial hardship to such individual or would be against equity and good conscience.
(July 1, 1944, ch. 373, title IV, § 487, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 869; amended
Pub. L. 100–607, title I, § 151, title VI, § 635, Nov.
4, 1988, 102 Stat. 3058, 3148; Pub. L. 101–93, § 5(d),
Aug. 16, 1989, 103 Stat. 612; Pub. L. 101–239, title
VI, § 6103(e)(7), Dec. 19, 1989, 103 Stat. 2208; Pub.
L. 102–321, title I, § 163(b)(4), July 10, 1992, 106
Stat. 376; Pub. L. 103–43, title XVI, §§ 1601, 1602,
1632, 1641, title XX, § 2008(b)(14), June 10, 1993, 107
Stat. 181, 186, 211; Pub. L. 106–129, § 2(b)(2), Dec.
6, 1999, 113 Stat. 1670; Pub. L. 107–206, title I,
§ 804(a), (b), Aug. 2, 2002, 116 Stat. 874; Pub. L.
109–482, title I, § 103(b)(47), Jan. 15, 2007, 120 Stat.
3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out subsec.
(d) which related to authorization and apportionment
of appropriations.
2002—Pub. L. 107–206 inserted ‘‘Ruth L. Kirschstein’’
before ‘‘National Research Service Award’’ and ‘‘National Research Service Awards’’ wherever appearing in
section catchline and text.
1999—Subsec. (d)(3). Pub. L. 106–129 substituted
‘‘Agency for Healthcare Research and Quality’’ for
‘‘Agency for Health Care Policy and Research’’.
1993—Subsec. (a)(1)(C). Pub. L. 103–43, § 1632, added
subpar. (C).
Subsec. (a)(4). Pub. L. 103–43, § 1601, added par. (4).
Subsec. (c)(1), (2). Pub. L. 103–43, § 1602, added pars. (1)
and (2) and struck out former pars. (1) and (2) which
read as follows:
‘‘(1) Each individual who is awarded a National Research Service Award (other than an individual who is
a pre-baccalaureate student who is awarded a National
Research Service Award for research training) shall, in
accordance with paragraph (3), engage in health research or teaching or any combination thereof which is
in accordance with the usual patterns of academic employment, for a period computed in accordance with
paragraph (2).
‘‘(2) For each month for which an individual receives
a National Research Service Award which is made for
a period in excess of twelve months, such individual
shall engage in one month of health research or teaching or any combination thereof which is in accordance
with the usual patterns of academic employment.’’
Subsec. (d). Pub. L. 103–43, § 1641(1), amended first sentence generally. Prior to amendment, first sentence
read as follows: ‘‘For the purpose of making payments
under National Research Service Awards and under
grants for such Awards, there are authorized to be appropriated $300,000,000 for fiscal year 1989 and such sums
as may be necessary for fiscal year 1990.’’
Subsec. (d)(3). Pub. L. 103–43, §§ 1641(2), 2008(b)(14), substituted ‘‘1 percent’’ for ‘‘one-half of one percent’’ in
two places, ‘‘293k, 293l, or 293m’’ for ‘‘295g, 295g–4, or
295g–6’’, and ‘‘242b(a)’’ for ‘‘242b(a)(3)’’.
1992—Subsec. (a)(1). Pub. L. 102–321 struck out ‘‘and
the Alcohol, Drug Abuse, and Mental Health Administration’’ before ‘‘in matters relating to’’ in subpar.
(A)(i) and struck out ‘‘or the Alcohol, Drug Abuse, and
Mental Health Administration’’ before ‘‘shall be considered’’ in last sentence.
1989—Subsec. (d)(3). Pub. L. 101–93 directed that par.
(3), as similarly amended by sections 151(2) and 635 of
Pub. L. 100–607, be amended to read as if the amendment made by such section 635 had not been enacted.
See 1988 Amendment note below.
Subsec. (d)(3)(B). Pub. L. 101–239 substituted ‘‘Agency
for Health Care Policy and Research’’ for ‘‘National
Center for Health Services Research and Health Care
Technology Assessment’’.

§ 288–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1988—Subsec. (d). Pub. L. 100–607, § 151(1), amended
first sentence generally. Prior to amendment, first sentence read as follows: ‘‘There are authorized to be appropriated to make payments under National Research
Service Awards and under grants for such awards
$244,000,000 for fiscal year 1986, $260,000,000 for fiscal
year 1987, and $275,000,000 for fiscal year 1988.’’
Subsec. (d)(3). Pub. L. 100–607, §§ 151(2), 635, made identical amendments, inserting ‘‘to the Secretary, acting
through the Administrator of the Health Resources and
Services Administration,’’ after first reference to
‘‘available’’.
CHANGE OF NAME
Pub. L. 107–206, title I, § 804(c), Aug. 2, 2002, 116 Stat.
874, provided that: ‘‘Any reference in any law (other
than this Act [see Tables for classification]), regulation, document, record, map, or other paper of the
United States to ‘National Research Service Awards’
shall be considered to be a reference to ‘Ruth L.
Kirschstein National Research Service Awards’.’’

Page 622

purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1994 through 2001.’’
1998—Subsec. (a). Pub. L. 105–392, § 410(a)(1), substituted ‘‘$35,000’’ for ‘‘$20,000’’.
Subsec. (c). Pub. L. 105–392, § 410(a)(2), substituted
‘‘2001’’ for ‘‘1996’’.
1993—Pub. L. 103–43 amended section generally, in
subsec. (a) redesignating former par. (1) as entire subsec., striking out provisions setting a deadline for implementation of the program and former par. (2) containing a limitation that the health professional have
a substantial amount of educational loans relative to
income and not have been employed at the National Institutes of Health during the 1-year period preceding
Nov. 4, 1988, reenacting subsec. (b) without change, and
in subsec. (c) redesignating former par. (1) as entire
subsec., substituting authorization of appropriations
for fiscal years 1994 through 1996 for authorization of
appropriations for fiscal years 1989 through 1991, and
striking out former par. (2) relating to continued availability of appropriated amounts.

EFFECTIVE DATE OF 2007 AMENDMENT

EFFECTIVE DATE OF 2007 AMENDMENT

Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

EFFECTIVE DATE OF 1992 AMENDMENT

EFFECTIVE DATE OF 1993 AMENDMENT

Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

Section 1611(b) of Pub. L. 103–43 provided that: ‘‘The
amendment made by subsection (a) [amending this section] does not apply to any agreement entered into
under section 487A of the Public Health Service Act
[this section] before the date of the enactment of this
Act [June 10, 1993]. Each such agreement continues to
be subject to the terms of the agreement in effect on
the day before such date.’’

§ 288–1. Loan repayment program for research
with respect to acquired immune deficiency
syndrome
(a) In general
The Secretary shall carry out a program of entering into agreements with appropriately qualified health professionals under which such
health professionals agree to conduct, as employees of the National Institutes of Health, research with respect to acquired immune deficiency syndrome in consideration of the Federal
Government agreeing to repay, for each year of
such service, not more than $35,000 of the principal and interest of the educational loans of
such health professionals.
(b) Applicability of certain provisions
With respect to the National Health Service
Corps Loan Repayment Program established in
subpart III of part D of subchapter II of this
chapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this
section, apply to the program established in
such subsection (a) of this section in the same
manner and to the same extent as such provisions apply to the National Health Service Corps
Loan Repayment Program established in such
subpart.

§ 288–2. Loan repayment program for research
with respect to contraception and infertility

AMENDMENTS

(a) Establishment
The Secretary, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, shall establish a program of entering into
contracts with qualified health professionals (including graduate students) under which such
health professionals agree to conduct research
with respect to contraception, or with respect to
infertility, in consideration of the Federal Government agreeing to repay, for each year of such
service, not more than $35,000 of the principal
and interest of the educational loans of such
health professionals.
(b) Contracts, obligated service, breach of contract
The provisions of sections 254l–1, 254m, and
254o of this title shall, except as inconsistent
with subsection (a) of this section, apply to the
program established in subsection (a) of this section to the same extent and in the same manner
as such provisions apply to the National Health
Service Corps Loan Repayment Program established in subpart III of part D of subchapter II of
this chapter.
(c) Availability of funds
Amounts available for carrying out this section shall remain available until the expiration
of the second fiscal year beginning after the fiscal year for which the amounts were made available.

2007—Subsec. (c). Pub. L. 109–482 struck out heading
and text of subsec. (c). Text read as follows: ‘‘For the

(July 1, 1944, ch. 373, title IV, § 487B, as added
Pub. L. 103–43, title X, § 1002, June 10, 1993, 107

(July 1, 1944, ch. 373, title IV, § 487A, as added
Pub. L. 100–607, title VI, § 634(a), Nov. 4, 1988, 102
Stat. 3148; amended Pub. L. 103–43, title XVI,
§ 1611(a), June 10, 1993, 107 Stat. 181; Pub. L.
105–392, title IV, § 410(a), Nov. 13, 1998, 112 Stat.
3589; Pub. L. 109–482, title I, § 103(b)(48), Jan. 15,
2007, 120 Stat. 3688.)

Page 623

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 166; amended Pub. L. 105–392, title IV,
§ 410(b), Nov. 13, 1998, 112 Stat. 3589; Pub. L.
110–154, § 1(b)(8), Dec. 21, 2007, 121 Stat. 1827.)
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–154, which directed substitution of ‘‘Eunice Kennedy Shriver National Institute of Child Health and Human Development’’ for ‘‘National Institute on Child Health and Human Development’’, was executed by making the substitution for
‘‘National Institute of Child Health and Human Development’’ to reflect the probable intent of Congress.
1998—Subsec. (a). Pub. L. 105–392 substituted ‘‘$35,000’’
for ‘‘$20,000’’.

§ 288–3. Loan repayment program for research
generally
(a) In general
(1) Authority for program
Subject to paragraph (2), the Secretary shall
carry out a program of entering into contracts
with appropriately qualified health professionals under which such health professionals
agree to conduct research, as employees of the
National Institutes of Health, in consideration
of the Federal Government agreeing to repay,
for each year of such service, not more than
$35,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to
paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the
National Institutes of Health for purposes of
paragraph (1) for a period of not less than 3
years.
(b) Applicability of certain provisions
With respect to the National Health Service
Corps Loan Repayment Program established in
subpart III of part D of subchapter II of this
chapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this
section, apply to the program established in
such subsection (a) of this section in the same
manner and to the same extent as such provisions apply to the National Health Service Corps
Loan Repayment Program established in such
subpart.
(July 1, 1944, ch. 373, title IV, § 487C, as added
Pub. L. 103–43, title XVI, § 1621, June 10, 1993, 107
Stat. 182; amended Pub. L. 105–392, title IV,
§ 410(c), Nov. 13, 1998, 112 Stat. 3589.)
AMENDMENTS
1998—Subsec. (a)(1).
‘‘$35,000’’ for ‘‘$20,000’’.

Pub.

L.

105–392

substituted

§ 288–4. Undergraduate scholarship program regarding professions needed by National Research Institutes
(a) Establishment of program
(1) In general
Subject to section 288(a)(1)(C) of this title,
the Secretary, acting through the Director of
NIH, may carry out a program of entering into

§ 288–4

contracts with individuals described in paragraph (2) under which—
(A) the Director of NIH agrees to provide
to the individuals scholarships for pursuing,
as undergraduates at accredited institutions
of higher education, academic programs appropriate for careers in professions needed
by the National Institutes of Health; and
(B) the individuals agree to serve as employees of the National Institutes of Health,
for the period described in subsection (c) of
this section, in positions that are needed by
the National Institutes of Health and for
which the individuals are qualified.
(2) Individuals from disadvantaged backgrounds
The individuals referred to in paragraph (1)
are individuals who—
(A) are enrolled or accepted for enrollment
as full-time undergraduates at accredited institutions of higher education; and
(B) are from disadvantaged backgrounds.
(b) Facilitation of interest of students in careers
at National Institutes of Health
In providing employment to individuals pursuant to contracts under subsection (a)(1) of this
section, the Director of NIH shall carry out activities to facilitate the interest of the individuals in pursuing careers as employees of the National Institutes of Health.
(c) Period of obligated service
(1) Duration of service
For purposes of subparagraph (B) of subsection (a)(1) of this section, the period of
service for which an individual is obligated to
serve as an employee of the National Institutes of Health is, subject to paragraph (2)(A),
12 months for each academic year for which
the scholarship under such subsection is provided.
(2) Schedule for service
(A) Subject to subparagraph (B), the Director of NIH may not provide a scholarship
under subsection (a) of this section unless the
individual applying for the scholarship agrees
that—
(i) the individual will serve as an employee
of the National Institutes of Health fulltime for not less than 10 consecutive weeks
of each year during which the individual is
attending the educational institution involved and receiving such a scholarship;
(ii) the period of service as such an employee that the individual is obligated to
provide under clause (i) is in addition to the
period of service as such an employee that
the individual is obligated to provide under
subsection (a)(1)(B) of this section; and
(iii) not later than 60 days after obtaining
the educational degree involved, the individual will begin serving full-time as such an
employee in satisfaction of the period of
service that the individual is obligated to
provide under subsection (a)(1)(B) of this section.
(B) The Director of NIH may defer the obligation of an individual to provide a period of
service under subsection (a)(1)(B) of this sec-

§ 288–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion, if the Director determines that such a
deferral is appropriate.
(3) Applicability of certain provisions relating
to appointment and compensation
For any period in which an individual provides service as an employee of the National
Institutes of Health in satisfaction of the obligation of the individual under subsection
(a)(1)(B) of this section or paragraph (2)(A)(i),
the individual may be appointed as such an
employee without regard to the provisions of
title 5 relating to appointment and compensation.
(d) Provisions regarding scholarship
(1) Approval of academic program
The Director of NIH may not provide a
scholarship under subsection (a) of this section for an academic year unless—
(A) the individual applying for the scholarship has submitted to the Director a proposed academic program for the year and the
Director has approved the program; and
(B) the individual agrees that the program
will not be altered without the approval of
the Director.
(2) Academic standing
The Director of NIH may not provide a
scholarship under subsection (a) of this section for an academic year unless the individual applying for the scholarship agrees to
maintain an acceptable level of academic
standing, as determined by the educational institution involved in accordance with regulations issued by the Secretary.
(3) Limitation on amount
The Director of NIH may not provide a
scholarship under subsection (a) of this section for an academic year in an amount exceeding $20,000.
(4) Authorized uses
A scholarship provided under subsection (a)
of this section may be expended only for tuition expenses, other reasonable educational
expenses, and reasonable living expenses incurred in attending the school involved.
(5) Contract regarding direct payments to institution
In the case of an institution of higher education with respect to which a scholarship
under subsection (a) of this section is provided, the Director of NIH may enter into a
contract with the institution under which the
amounts provided in the scholarship for tuition and other educational expenses are paid
directly to the institution.
(e) Penalties for breach of scholarship contract
The provisions of section 254o of this title
shall apply to the program established in subsection (a) of this section to the same extent
and in the same manner as such provisions apply
to the National Health Service Corps Loan Repayment Program established in section 254l–1
of this title.
(f) Requirement of application
The Director of NIH may not provide a scholarship under subsection (a) of this section unless

Page 624

an application for the scholarship is submitted
to the Director and the application is in such
form, is made in such manner, and contains such
agreements, assurances, and information as the
Director determines to be necessary to carry out
this section.
(g) Availability of authorization of appropriations
Amounts appropriated for a fiscal year for
scholarships under this section shall remain
available until the expiration of the second fiscal year beginning after the fiscal year for
which the amounts were appropriated.
(July 1, 1944, ch. 373, title IV, § 487D, as added
Pub. L. 103–43, title XVI, § 1631, June 10, 1993, 107
Stat. 183.)
§ 288–5. Loan repayment program regarding clinical researchers from disadvantaged backgrounds
(a) Implementation of program
(1) In general
Subject to section 288(a)(1)(C) of this title,
the Secretary, acting through the Director of
NIH may, subject to paragraph (2), carry out a
program of entering into contracts with appropriately qualified health professionals who
are from disadvantaged backgrounds under
which such health professionals agree to conduct clinical research in consideration of the
Federal Government agreeing to pay, for each
year of such service, not more than $35,000 of
the principal and interest of the educational
loans of the health professionals.
(2) Limitation
The Director of NIH may not enter into a
contract with a health professional pursuant
to paragraph (1) unless such professional has a
substantial amount of education loans relative
to income.
(3) Applicability of certain provisions regarding obligated service
Except to the extent inconsistent with this
section, the provisions of sections 254l–1, 254m
and 254o of this title shall apply to the program established in paragraph (1) to the same
extent and in the same manner as such provisions apply to the National Health Service
Corps Loan Repayment Program established
in section 254l–1 of this title.
(b) Availability of authorization of appropriations
Amounts appropriated for a fiscal year for
contracts under subsection (a) of this section
shall remain available until the expiration of
the second fiscal year beginning after the fiscal
year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title IV, § 487E, as added
Pub. L. 103–43, title XVI, § 1631, June 10, 1993, 107
Stat. 185; amended Pub. L. 105–392, title IV,
§ 410(d), Nov. 13, 1998, 112 Stat. 3589; Pub. L.
106–554, § 1(a)(1) [title II, § 223], Dec. 21, 2000, 114
Stat. 2763, 2763A–30.)
AMENDMENTS
2000—Subsec. (a)(1). Pub. L. 106–554 struck out ‘‘as
employees of the National Institutes of Health’’ after
‘‘conduct clinical research’’.

Page 625

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1998—Subsec. (a)(1). Pub. L. 105–392, § 410(d)(1), substituted ‘‘$35,000’’ for ‘‘$20,000’’.
Subsec. (a)(3). Pub. L. 105–392, § 410(d)(2), substituted
‘‘254l–1, 254m’’ for ‘‘254m’’.

§ 288–5a. Loan repayment program regarding
clinical researchers
(a) In general
The Secretary, acting through the Director of
the National Institutes of Health, shall establish
a program to enter into contracts with qualified
health professionals under which such health
professionals agree to conduct clinical research,
in consideration of the Federal Government
agreeing to repay, for each year of service conducting such research, not more than $35,000 of
the principal and interest of the educational
loans of such health professionals.
(b) Application of provisions
The provisions of sections 254l–1, 254m, and
254o of this title shall, except as inconsistent
with subsection (a) of this section, apply to the
program established under subsection (a) of this
section to the same extent and in the same manner as such provisions apply to the National
Health Service Corps Loan Repayment Program
established in subpart III of part D of subchapter
II of this chapter.
(July 1, 1944, ch. 373, title IV, § 487F, as added
Pub. L. 106–505, title II, § 205, Nov. 13, 2000, 114
Stat. 2329; amended Pub. L. 109–482, title I,
§ 103(b)(49), Jan. 15, 2007, 120 Stat. 3689.)
CODIFICATION
Another section 487F of act July 1, 1944, is classified
to section 288–6 of this title.
AMENDMENTS
2007—Subsec. (c). Pub. L. 109–482 struck out subsec.
(c) which related to authorization and availability of
appropriations.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 288–6. Pediatric research loan repayment program
(a) In general
The Secretary, in consultation with the Director of NIH, may establish a pediatric research
loan repayment program. Through such program—
(1) the Secretary shall enter into contracts
with qualified health professionals under
which such professionals will agree to conduct
pediatric research, including pediatric pharmacological research, in consideration of the
Federal Government agreeing to repay, for
each year of such service, not more than
$35,000 of the principal and interest of the educational loans of such professionals; and
(2) the Secretary shall, for the purpose of
providing reimbursements for tax liability resulting from payments made under paragraph
(1) on behalf of an individual, make payments,
in addition to payments under such paragraph,
to the individual in an amount equal to 39 per-

§ 288a

cent of the total amount of loan repayments
made for the taxable year involved.
(b) Application of other provisions
The provisions of sections 254l–1, 254m, and
254o of this title shall, except as inconsistent
with paragraph (1), apply to the program established under such paragraph to the same extent
and in the same manner as such provisions apply
to the National Health Service Corps Loan Repayment Program established under subpart III
of part D of subchapter II of this chapter.
(c) Funding
(1) In general
For the purpose of carrying out this section
with respect to a national research institute
the Secretary may reserve, from amounts appropriated for such institute for the fiscal
year involved, such amounts as the Secretary
determines to be appropriate.
(2) Availability of funds
Amounts made available to carry out this
section shall remain available until the expiration of the second fiscal year beginning after
the fiscal year for which such amounts were
made available.
(July 1, 1944, ch. 373, title IV, § 487F, as added
Pub. L. 106–310, div. A, title X, § 1002(b), Oct. 17,
2000, 114 Stat. 1129; amended Pub. L. 110–85, title
V, § 503(b), Sept. 27, 2007, 121 Stat. 890.)
CODIFICATION
Another section 487F of act July 1, 1944, is classified
to section 288–5a of this title.
AMENDMENTS
2007—Subsec. (a)(1). Pub. L. 110–85 inserted ‘‘including
pediatric pharmacological research,’’ after ‘‘pediatric
research,’’.

§ 288a. Visiting Scientist Awards
(a) The Secretary may make awards (hereafter
in this section referred to as ‘‘Visiting Scientist
Awards’’) to outstanding scientists who agree to
serve as visiting scientists at institutions of
postsecondary education which have significant
enrollments of disadvantaged students. Visiting
Scientist Awards shall be made by the Secretary
to enable the faculty and students of such institutions to draw upon the special talents of scientists from other institutions for the purpose
of receiving guidance, advice, and instruction
with regard to research, teaching, and curriculum development in the biomedical and behavioral sciences and such other aspects of these
sciences as the Secretary shall deem appropriate.
(b) The amount of each Visiting Scientist
Award shall include such sum as shall be commensurate with the salary or remuneration
which the individual receiving the award would
have been entitled to receive from the institution with which the individual has, or had, a
permanent or immediately prior affiliation. Eligibility for and terms of Visiting Scientist
Awards shall be determined in accordance with
regulations the Secretary shall prescribe.
(July 1, 1944, ch. 373, title IV, § 488, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 872.)

§ 288b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 288b. Studies respecting biomedical and behavioral research personnel
(a) Scope of undertaking
The Secretary shall, in accordance with subsection (b) of this section, arrange for the conduct of a continuing study to—
(1) establish (A) the Nation’s overall need for
biomedical and behavioral research personnel,
(B) the subject areas in which such personnel
are needed and the number of such personnel
needed in each such area, and (C) the kinds
and extent of training which should be provided such personnel;
(2) assess (A) current training programs
available for the training of biomedical and
behavioral research personnel which are conducted under this chapter, at or through national research institutes under the National
Institutes of Health, and (B) other current
training programs available for the training of
such personnel;
(3) identify the kinds of research positions
available to and held by individuals completing such programs;
(4) determine, to the extent feasible, whether the programs referred to in clause (B) of
paragraph (2) would be adequate to meet the
needs established under paragraph (1) if the
programs referred to in clause (A) of paragraph (2) were terminated; and
(5) determine what modifications in the programs referred to in paragraph (2) are required
to meet the needs established under paragraph
(1).
(b) Arrangement with National Academy of Sciences or other nonprofit private groups or
associations
(1) The Secretary shall request the National
Academy of Sciences to conduct the study required by subsection (a) of this section under an
arrangement under which the actual expenses
incurred by such Academy in conducting such
study will be paid by the Secretary. If the National Academy of Sciences is willing to do so,
the Secretary shall enter into such an arrangement with such Academy for the conduct of such
study.
(2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the Secretary shall enter into a
similar arrangement with other appropriate
nonprofit private groups or associations under
which such groups or associations will conduct
such study and prepare and submit the reports
thereon as provided in subsection (c) of this section.1
(3) The National Academy of Sciences or other
group or association conducting the study required by subsection (a) of this section shall
conduct such study in consultation with the Director of NIH.
(July 1, 1944, ch. 373, title IV, § 489, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 872; amended
Pub. L. 102–321, title I, § 163(b)(5), July 10, 1992,
106 Stat. 376.)
REFERENCES IN TEXT
Subsection (c), referred to in subsec. (b)(2), was omitted from the Code. See Codification note below.
1 See

References in Text note below.

Page 626

CODIFICATION
Subsec. (c) of this section, which required the Secretary to submit a report on results of the study required under subsec. (a) of this section to certain committees of Congress at least once every four years, terminated, effective May 15, 2000, pursuant to section 3003
of Pub. L. 104–66, as amended, set out as a note under
section 1113 of Title 31, Money and Finance. See, also,
page 96 of House Document No. 103–7.
AMENDMENTS
1992—Subsec. (a)(2). Pub. L. 102–321 struck out ‘‘and
institutes under the Alcohol, Drug Abuse, and Mental
Health Administration’’ after ‘‘National Institutes of
Health’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

PART H—GENERAL PROVISIONS
AMENDMENTS
1993—Pub. L. 103–43, title I, § 141(a)(2), June 10, 1993,
107 Stat. 136, redesignated part G ‘‘General Provisions’’
as H. Former part H ‘‘National Foundation for Biomedical Research’’ redesignated I.

§ 289. Institutional review boards; ethics guidance program
(a) The Secretary shall by regulation require
that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves
the conduct of biomedical or behavioral research
involving human subjects submit in or with its
application for such grant, contract, or cooperative agreement assurances satisfactory to the
Secretary that it has established (in accordance
with regulations which the Secretary shall prescribe) a board (to be known as an ‘‘Institutional
Review Board’’) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to
protect the rights of the human subjects of such
research.
(b)(1) The Secretary shall establish a program
within the Department of Health and Human
Services under which requests for clarification
and guidance with respect to ethical issues
raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately.
(2) The Secretary shall establish a process for
the prompt and appropriate response to information provided to the Director of NIH respecting
incidences of violations of the rights of human
subjects of research for which funds have been
made available under this chapter. The process
shall include procedures for the receiving of reports of such information from recipients of
funds under this chapter and taking appropriate
action with respect to such violations.
(July 1, 1944, ch. 373, title IV, § 491, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 873.)
STUDY CONCERNING RESEARCH INVOLVING CHILDREN
Pub. L. 107–109, § 12, Jan. 4, 2002, 115 Stat. 1416, provided that:
‘‘(a) CONTRACT WITH INSTITUTE OF MEDICINE.—The
Secretary of Health and Human Services shall enter
into a contract with the Institute of Medicine for—

Page 627

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(1) the conduct, in accordance with subsection (b),
of a review of—
‘‘(A) Federal regulations in effect on the date of
the enactment of this Act [Jan. 4, 2002] relating to
research involving children;
‘‘(B) federally prepared or supported reports relating to research involving children; and
‘‘(C) federally supported evidence-based research
involving children; and
‘‘(2) the submission to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, not later than two years after the
date of enactment of this Act, of a report concerning
the review conducted under paragraph (1) that includes recommendations on best practices relating to
research involving children.
‘‘(b) AREAS OF REVIEW.—In conducting the review
under subsection (a)(1), the Institute of Medicine shall
consider the following:
‘‘(1) The written and oral process of obtaining and
defining ‘assent’, ‘permission’ and ‘informed consent’
with respect to child clinical research participants
and the parents, guardians, and the individuals who
may serve as the legally authorized representatives
of such children (as defined in subpart A of part 46 of
title 45, Code of Federal Regulations).
‘‘(2) The expectations and comprehension of child
research participants and the parents, guardians, or
legally authorized representatives of such children,
for the direct benefits and risks of the child’s research involvement, particularly in terms of research
versus therapeutic treatment.
‘‘(3) The definition of ‘minimal risk’ with respect to
a healthy child or a child with an illness.
‘‘(4) The appropriateness of the regulations applicable to children of differing ages and maturity levels,
including regulations relating to legal status.
‘‘(5) Whether payment (financial or otherwise) may
be provided to a child or his or her parent, guardian,
or legally authorized representative for the participation of the child in research, and if so, the amount
and type of payment that may be made.
‘‘(6) Compliance with the regulations referred to in
subsection (a)(1)(A), the monitoring of such compliance (including the role of institutional review
boards), and the enforcement actions taken for violations of such regulations.
‘‘(7) The unique roles and responsibilities of institutional review boards in reviewing research involving
children, including composition of membership on institutional review boards.
‘‘(c) REQUIREMENTS OF EXPERTISE.—The Institute of
Medicine shall conduct the review under subsection
(a)(1) and make recommendations under subsection
(a)(2) in conjunction with experts in pediatric medicine,
pediatric research, and the ethical conduct of research
involving children.’’
REQUIREMENT FOR ADDITIONAL PROTECTIONS FOR
CHILDREN INVOLVED IN RESEARCH
Pub. L. 106–310, div. A, title XXVII, § 2701, Oct. 17,
2000, 114 Stat. 1167, as amended by Pub. L. 106–505, title
X, § 1001(a), Nov. 13, 2000, 114 Stat. 2350, provided that:
‘‘Notwithstanding any other provision of law, not later
than 6 months after the date of the enactment of this
Act [Oct. 17, 2000], the Secretary of Health and Human
Services shall require that all research involving children that is conducted, supported, or regulated by the
Department of Health and Human Services be in compliance with subpart D of part 46 of title 45, Code of
Federal Regulations.’’
[Pub. L. 106–505, title X, § 1001(b), Nov. 13, 2000, 114
Stat. 2350, provided that: ‘‘The amendment made by
subsection (a) [amending section 2701 of Pub. L. 106–310,
set out above] takes effect on the date of the enactment of the Children’s Health Act of 2000 [Oct. 17,
2000].’’]

§ 289a

§ 289a. Peer review requirements
(a) Applications for biomedical and behavioral
research grants, cooperative agreements,
and contracts; regulations
(1) The Secretary, acting through the Director
of NIH, shall by regulation require appropriate
technical and scientific peer review of—
(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and
(B) applications made for biomedical and behavioral research and development contracts
to be administered through the National Institutes of Health.
(2) Regulations promulgated under paragraph
(1) shall require that the review of applications
made for grants, contracts, and cooperative
agreements required by the regulations be conducted—
(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20,
1985, to grants under this chapter for biomedical and behavioral research, and
(B) to the extent practical, by technical and
scientific peer review groups performing such
review on or before November 20, 1985,
and shall authorize such review to be conducted
by groups appointed under sections 282(b)(16) and
284(c)(3) of this title.
(b) Periodic review of research at National Institutes of Health
The Director of NIH shall establish procedures
for periodic technical and scientific peer review
of research at the National Institutes of Health.
Such procedures shall require that—
(1) the reviewing entity be provided a written description of the research to be reviewed,
and
(2) the reviewing entity provide the advisory
council of the national research institute involved with such description and the results of
the review by the entity,
and shall authorize such review to be conducted
by groups appointed under sections 282(b)(6) 1
and 284(c)(3) of this title.
(c) Compliance with requirements for inclusion
of women and minorities in clinical research
(1) In technical and scientific peer review
under this section of proposals for clinical research, the consideration of any such proposal
(including the initial consideration) shall, except as provided in paragraph (2), include an
evaluation of the technical and scientific merit
of the proposal regarding compliance with section 289a–2 of this title.
(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 289a–2 of this title, is not
subject to the requirement of subsection (a) of
such section regarding the inclusion of women
and members of minority groups as subjects in
clinical research.
(July 1, 1944, ch. 373, title IV, § 492, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended
1 See

References in Text note below.

§ 289a–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 103–43, title I, § 132, June 10, 1993, 107
Stat. 135; Pub. L. 109–482, title I, § 102(f)(1)(B),
Jan. 15, 2007, 120 Stat. 3685.)
REFERENCES IN TEXT
Section 282(b)(6) of this title, referred to in subsec.
(b), was redesignated section 282(b)(16) by Pub. L.
109–482, title I, § 102(a)(3), Jan. 15, 2007, 120 Stat. 3681.
AMENDMENTS
2007—Subsec. (a)(2). Pub. L. 109–482 substituted ‘‘sections 282(b)(16)’’ for ‘‘sections 282(b)(6)’’ in concluding
provisions.
1993—Subsec. (c). Pub. L. 103–43 added subsec. (c).
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 289a–1. Certain provisions regarding review
and approval of proposals for research
(a) Review as precondition to research
(1) Protection of human research subjects
(A) In the case of any application submitted
to the Secretary for financial assistance to
conduct research, the Secretary may not approve or fund any application that is subject
to review under section 289(a) of this title by
an Institutional Review Board unless the application has undergone review in accordance
with such section and has been recommended
for approval by a majority of the members of
the Board conducting such review.
(B) In the case of research that is subject to
review under procedures established by the
Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may
not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.
(2) Peer review
In the case of any proposal for the National
Institutes of Health to conduct or support research, the Secretary may not approve or fund
any proposal that is subject to technical and
scientific peer review under section 289a of
this title unless the proposal has undergone
such review in accordance with such section
and has been recommended for approval by a
majority of the members of the entity conducting such review, and unless a majority of
the voting members of the appropriate advisory council under section 284a of this title, or
as applicable, of the advisory council under
section 282(k) of this title, has recommended
the proposal for approval.
(b) Ethical review of research
(1) Procedures regarding withholding of funds
If research has been recommended for approval for purposes of subsection (a) of this
section, the Secretary may not withhold funds
for the research because of ethical considerations unless—
(A) the Secretary convenes an advisory
board in accordance with paragraph (5) to
study such considerations; and
(B)(i) the majority of the advisory board
recommends that, because of such consider-

Page 628

ations, the Secretary withhold funds for the
research; or
(ii) the majority of such board recommends that the Secretary not withhold
funds for the research because of such considerations, but the Secretary finds, on the
basis of the report submitted under paragraph (5)(B)(ii), that the recommendation is
arbitrary and capricious.
(2) Rules of construction
Paragraph (1) may not be construed as prohibiting the Secretary from withholding funds
for research on the basis of—
(A) the inadequacy of the qualifications of
the entities that would be involved with the
conduct of the research (including the entity
that would directly receive the funds from
the Secretary), subject to the condition
that, with respect to the process of review
through which the research was recommended for approval for purposes of subsection (a) of this section, all findings regarding such qualifications made in such
process are conclusive; or
(B) the priorities established by the Secretary for the allocation of funds among
projects of research that have been so recommended.
(3) Applicability
The limitation established in paragraph (1)
regarding the authority to withhold funds because of ethical considerations shall apply
without regard to whether the withholding of
funds on such basis is characterized as a disapproval, a moratorium, a prohibition, or
other characterization.
(4) Preliminary matters regarding use of procedures
(A) If the Secretary makes a determination
that an advisory board should be convened for
purposes of paragraph (1), the Secretary shall,
through a statement published in the Federal
Register, announce the intention of the Secretary to convene such a board.
(B) A statement issued under subparagraph
(A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory
board involved. The Secretary shall consider
such recommendations in making appointments to the board.
(C) The Secretary may not make appointments to an advisory board under paragraph
(1) until the expiration of the 30-day period beginning on the date on which the statement
required in subparagraph (A) is made with respect to the board.
(5) Ethics advisory boards
(A) Any advisory board convened for purposes of paragraph (1) shall be known as an
ethics advisory board (in this paragraph referred to as an ‘‘ethics board’’).
(B)(i) An ethics board shall advise, consult
with, and make recommendations to the Secretary regarding the ethics of the project of
biomedical or behavioral research with respect
to which the board has been convened.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) Not later than 180 days after the date on
which the statement required in paragraph
(4)(A) is made with respect to an ethics board,
the board shall submit to the Secretary, and
to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the
board regarding the project of research involved and making a recommendation under
clause (i) of whether the Secretary should or
should not withhold funds for the project. The
report shall include the information considered in making the findings.
(C) An ethics board shall be composed of no
fewer than 14, and no more than 20, individuals
who are not officers or employees of the
United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical
and behavioral research. Of the members of
the board—
(i) no fewer than 1 shall be an attorney;
(ii) no fewer than 1 shall be an ethicist;
(iii) no fewer than 1 shall be a practicing
physician;
(iv) no fewer than 1 shall be a theologian;
and
(v) no fewer than one-third, and no more
than one-half, shall be scientists with substantial accomplishments in biomedical or
behavioral research.
(D) The term of service as a member of an
ethics board shall be for the life of the board.
If such a member does not serve the full term
of such service, the individual appointed to fill
the resulting vacancy shall be appointed for
the remainder of the term of the predecessor
of the individual.
(E) A member of an ethics board shall be
subject to removal from the board by the Secretary for neglect of duty or malfeasance or
for other good cause shown.
(F) The Secretary shall designate an individual from among the members of an ethics
board to serve as the chair of the board.
(G) In carrying out subparagraph (B)(i) with
respect to a project of research, an ethics
board shall conduct inquiries and hold public
hearings.
(H) In carrying out subparagraph (B)(i) with
respect to a project of research, an ethics
board shall have access to all relevant information possessed by the Department of Health
and Human Services, or available to the Secretary from other agencies.
(I) Members of an ethics board shall receive
compensation for each day engaged in carrying out the duties of the board, including time
engaged in traveling for purposes of such duties. Such compensation may not be provided
in an amount in excess of the maximum rate
of basic pay payable for GS–18 of the General
Schedule.
(J) The Secretary, acting through the Director of the National Institutes of Health, shall
provide to each ethics board reasonable staff
and assistance to carry out the duties of the
board.

§ 289a–2

(K) An ethics board shall terminate 30 days
after the date on which the report required in
subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.
(6) ‘‘Ethical considerations’’ defined
For purposes of this subsection, the term
‘‘ethical considerations’’ means considerations
as to whether the nature of the research involved is such that it is unethical to conduct
or support the research.
(July 1, 1944, ch. 373, title IV, § 492A, as added
Pub. L. 103–43, title I, § 101, June 10, 1993, 107
Stat. 126; amended Pub. L. 109–482, title I,
§ 102(e), Jan. 15, 2007, 120 Stat. 3684.)
AMENDMENTS
2007—Subsec. (a)(2). Pub. L. 109–482 inserted before period at end ‘‘, and unless a majority of the voting members of the appropriate advisory council under section
284a of this title, or as applicable, of the advisory council under section 282(k) of this title, has recommended
the proposal for approval’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 289a–2. Inclusion of women and minorities in
clinical research
(a) Requirement of inclusion
(1) In general
In conducting or supporting clinical research for purposes of this subchapter, the Director of NIH shall, subject to subsection (b) of
this section, ensure that—
(A) women are included as subjects in each
project of such research; and
(B) members of minority groups are included as subjects in such research.
(2) Outreach regarding participation as subjects
The Director of NIH, in consultation with
the Director of the Office of Research on Wom-

§ 289a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

en’s Health and the Director of the Office of
Research on Minority Health, shall conduct or
support outreach programs for the recruitment of women and members of minority
groups as subjects in projects of clinical research.
(b) Inapplicability of requirement
The requirement established in subsection (a)
of this section regarding women and members of
minority groups shall not apply to a project of
clinical research if the inclusion, as subjects in
the project, of women and members of minority
groups, respectively—
(1) is inappropriate with respect to the
health of the subjects;
(2) is inappropriate with respect to the purpose of the research; or
(3) is inappropriate under such other circumstances as the Director of NIH may designate.
(c) Design of clinical trials
In the case of any clinical trial in which
women or members of minority groups will
under subsection (a) of this section be included
as subjects, the Director of NIH shall ensure
that the trial is designed and carried out in a
manner sufficient to provide for a valid analysis
of whether the variables being studied in the
trial affect women or members of minority
groups, as the case may be, differently than
other subjects in the trial.
(d) Guidelines
(1) In general
Subject to paragraph (2), the Director of
NIH, in consultation with the Director of the
Office of Research on Women’s Health and the
Director of the Office of Research on Minority
Health, shall establish guidelines regarding
the requirements of this section. The guidelines shall include guidelines regarding—
(A) the circumstances under which the inclusion of women and minorities as subjects
in projects of clinical research is inappropriate for purposes of subsection (b) of this section;
(B) the manner in which clinical trials are
required to be designed and carried out for
purposes of subsection (c) of this section;
and
(C) the operation of outreach programs
under subsection (a) of this section.
(2) Certain provisions
With respect to the circumstances under
which the inclusion of women or members of
minority groups (as the case may be) as subjects in a project of clinical research is inappropriate for purposes of subsection (b) of this
section, the following applies to guidelines
under paragraph (1):
(A)(i) In the case of a clinical trial, the
guidelines shall provide that the costs of
such inclusion in the trial is not a permissible consideration in determining whether
such inclusion is inappropriate.
(ii) In the case of other projects of clinical
research, the guidelines shall provide that
the costs of such inclusion in the project is
not a permissible consideration in determining whether such inclusion is inappropriate

Page 630

unless the data regarding women or members of minority groups, respectively, that
would be obtained in such project (in the
event that such inclusion were required)
have been or are being obtained through
other means that provide data of comparable
quality.
(B) In the case of a clinical trial, the
guidelines may provide that such inclusion
in the trial is not required if there is substantial scientific data demonstrating that
there is no significant difference between—
(i) the effects that the variables to be
studied in the trial have on women or
members of minority groups, respectively;
and
(ii) the effects that the variables have on
the individuals who would serve as subjects in the trial in the event that such inclusion were not required.
(e) Date certain for guidelines; applicability
(1) Date certain
The guidelines required in subsection (d) of
this section shall be established and published
in the Federal Register not later than 180 days
after June 10, 1993.
(2) Applicability
For fiscal year 1995 and subsequent fiscal
years, the Director of NIH may not approve
any proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health unless the proposal
specifies the manner in which the research
will comply with this section.
(f) Reports by advisory councils
The advisory council of each national research
institute shall prepare biennial reports describing the manner in which the institute has complied with this section. Each such report shall
be submitted to the Director of the institute involved for inclusion in the biennial report under
section 283 of this title.
(g) Definitions
For purposes of this section:
(1) The term ‘‘project of clinical research’’
includes a clinical trial.
(2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director
of NIH shall, through the guidelines established under subsection (d) of this section, define the terms ‘‘minority group’’ and ‘‘subpopulation’’ for purposes of the preceding sentence.
(July 1, 1944, ch. 373, title IV, § 492B, as added
Pub. L. 103–43, title I, § 131, June 10, 1993, 107
Stat. 133.)
INAPPLICABILITY TO CURRENT PROJECTS
Section 133 of Pub. L. 103–43 provided that: ‘‘Section
492B of the Public Health Service Act, as added by section 131 of this Act [this section], shall not apply with
respect to projects of clinical research for which initial
funding was provided prior to the date of the enactment of this Act [June 10, 1993]. With respect to the inclusion of women and minorities as subjects in clinical
research conducted or supported by the National Institutes of Health, any policies of the Secretary of Health
and Human Services regarding such inclusion that are
in effect on the day before the date of the enactment of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

this Act shall continue to apply to the projects referred
to in the preceding sentence.’’

§ 289b. Office of Research Integrity
(a) In general
(1) Establishment of Office
Not later than 90 days after June 10, 1993, the
Secretary shall establish an office to be known
as the Office of Research Integrity (referred to
in this section as the ‘‘Office’’), which shall be
established as an independent entity in the
Department of Health and Human Services.
(2) Appointment of Director
The Office shall be headed by a Director,
who shall be appointed by the Secretary, be
experienced and specially trained in the conduct of research, and have experience in the
conduct of investigations of research misconduct. The Secretary shall carry out this
section acting through the Director of the Office. The Director shall report to the Secretary.
(3) Definitions
(A) The Secretary shall by regulation establish a definition for the term ‘‘research misconduct’’ for purposes of this section.
(B) For purposes of this section, the term
‘‘financial assistance’’ means a grant, contract, or cooperative agreement.
(b) Existence of administrative processes as condition of funding for research
The Secretary shall by regulation require that
each entity that applies for financial assistance
under this chapter for any project or program
that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary
that such entity has established and has in effect (in accordance with regulations which the
Secretary shall prescribe) an administrative
process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or sponsored
by such entity;
(2) an agreement that the entity will report
to the Director any investigation of alleged research misconduct in connection with projects
for which funds have been made available
under this chapter that appears substantial;
and
(3) an agreement that the entity will comply
with regulations issued under this section.
(c) Process for response of Director
The Secretary shall by regulation establish a
process to be followed by the Director for the
prompt and appropriate—
(1) response to information provided to the
Director respecting research misconduct in
connection with projects for which funds have
been made available under this chapter;
(2) receipt of reports by the Director of such
information from recipients of funds under
this chapter;
(3) conduct of investigations, when appropriate; and
(4) taking of other actions, including appropriate remedies, with respect to such misconduct.

§ 289b

(d) Monitoring by Director
The Secretary shall by regulation establish
procedures for the Director to monitor administrative processes and investigations that have
been established or carried out under this section.
(e) Protection of whistleblowers
(1) In general
In the case of any entity required to establish administrative processes under subsection
(b) of this section, the Secretary shall by regulation establish standards for preventing, and
for responding to the occurrence of retaliation
by such entity, its officials or agents, against
an employee in the terms and conditions of
employment in response to the employee having in good faith—
(A) made an allegation that the entity, its
officials or agents, has engaged in or failed
to adequately respond to an allegation of research misconduct; or
(B) cooperated with an investigation of
such an allegation.
(2) Monitoring by Secretary
The Secretary shall by regulation establish
procedures for the Director to monitor the implementation of the standards established by
an entity under paragraph (1) for the purpose
of determining whether the procedures have
been established, and are being utilized, in accordance with the standards established under
such paragraph.
(3) Noncompliance
The Secretary shall by regulation establish
remedies for noncompliance by an entity, its
officials or agents, which has engaged in retaliation in violation of the standards established
under paragraph (1). Such remedies may include termination of funding provided by the
Secretary for such project or recovery of funding being provided by the Secretary for such
project, or other actions as appropriate.
(July 1, 1944, ch. 373, title IV, § 493, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended
Pub. L. 103–43, title I, §§ 161, 163, June 10, 1993, 107
Stat. 140, 142.)
CODIFICATION
June 10, 1993, referred to in subsec. (a)(1), was in the
original ‘‘the date of enactment of this section’’ which
was translated as meaning the date of enactment of
Pub. L. 103–43, which amended this section generally, to
reflect the probable intent of Congress.
AMENDMENTS
1993—Pub. L. 103–43, § 161, amended section generally.
Prior to amendment, section read as follows:
‘‘(a) The Secretary shall by regulation require that
each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project
or program which involves the conduct of biomedical or
behavioral research submit in or with its application
for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity—
‘‘(1) has established (in accordance with regulations
which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in
connection with biomedical and behavioral research
conducted at or sponsored by such entity; and

§ 289b–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) will report to the Secretary any investigation
of alleged scientific fraud which appears substantial.
‘‘(b) The Director of NIH shall establish a process for
the prompt and appropriate response to information
provided the Director of NIH respecting scientific fraud
in connection with projects for which funds have been
made available under this chapter. The process shall
include procedures for the receiving of reports of such
information from recipients of funds under this chapter
and taking appropriate action with respect to such
fraud.’’
Subsec. (e). Pub. L. 103–43, § 163, added subsec. (e).
REGULATIONS
Section 165 of Pub. L. 103–43 provided that:
‘‘(a) ISSUANCE OF FINAL RULES.—
‘‘(1) IN GENERAL.—Not later than 180 days after the
date of the enactment of this Act [June 10, 1993], the
Secretary shall, subject to paragraph (2), issue the
final rule for each regulation required in section 493
or 493A of the Public Health Service Act [this section
and section 289b–1 of this title].
‘‘(2) DEFINITION OF RESEARCH MISCONDUCT.—Not
later than 90 days after the date on which the report
required in section 162(e) [107 Stat. 142] is submitted
to the Secretary, the Secretary shall issue the final
rule for the regulations required in section 493 of the
Public Health Service Act with respect to the definition of the term ‘research misconduct’.
‘‘(b) APPLICABILITY TO ONGOING INVESTIGATIONS.—The
final rule issued pursuant to subsection (a) for investigations under section 493 of the Public Health Service
Act [this section] does not apply to investigations commenced before the date of the enactment of this Act
[June 10, 1993] under authority of such section as in effect before such date.
‘‘(c) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘section 493 of the Public Health
Service Act’ means such section as amended by sections 161 and 163 of this Act [this section], except as
indicated otherwise in subsection (b).
‘‘(2) The term ‘section 493A of the Public Health
Service Act’ means such section as added by section
164 of this Act [section 289b–1 of this title].
‘‘(3) The term ‘Secretary’ means the Secretary of
Health and Human Services.’’

§ 289b–1. Protection against financial conflicts of
interest in certain projects of research
(a) Issuance of regulations
The Secretary shall by regulation define the
specific circumstances that constitute the existence of a financial interest in a project on the
part of an entity or individual that will, or may
be reasonably expected to, create a bias in favor
of obtaining results in such project that are consistent with such financial interest. Such definition shall apply uniformly to each entity or individual conducting a research project under
this chapter. In the case of any entity or individual receiving assistance from the Secretary
for a project of research described in subsection
(b) of this section, the Secretary shall by regulation establish standards for responding to, including managing, reducing, or eliminating, the
existence of such a financial interest. The entity
may adopt individualized procedures for implementing the standards.
(b) Relevant projects
A project of research referred to in subsection
(a) of this section is a project of clinical research whose purpose is to evaluate the safety
or effectiveness of a drug, medical device, or
treatment and for which such entity is receiving
assistance from the Secretary.

Page 632

(c) Identifying and reporting to Secretary
The Secretary shall by regulation require that
each entity described in subsection (a) of this
section that applies for assistance under this
chapter for any project described in subsection
(b) of this section submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary
that such entity has established and has in effect an administrative process under subsection (a) of this section to identify financial
interests (as defined under subsection (a) of
this section) that exist regarding the project;
and
(2) an agreement that the entity will report
to the Secretary such interests identified by
the entity and how any such interests identified by the entity will be managed or eliminated in order that the project in question will
be protected from bias that may stem from
such interests; and
(3) an agreement that the entity will comply
with regulations issued under this section.
(d) Monitoring of process
The Secretary shall monitor the establishment and conduct of the administrative process
established by an entity pursuant to subsection
(a) of this section.
(e) Response
In any case in which the Secretary determines
that an entity has failed to comply with subsection (c) of this section regarding a project of
research described in subsection (b) of this section, the Secretary—
(1) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest (as defined
under subsection (a) of this section) in each
public presentation of the results of such
project; and
(2) may take such other actions as the Secretary determines to be appropriate.
(f) Definitions
For purposes of this section:
(1) The term ‘‘financial interest’’ includes
the receipt of consulting fees or honoraria and
the ownership of stock or equity.
(2) The term ‘‘assistance’’, with respect to
conducting a project of research, means a
grant, contract, or cooperative agreement.
(July 1, 1944, ch. 373, title IV, § 493A, as added
Pub. L. 103–43, title I, § 164, June 10, 1993, 107
Stat. 142.)
REGULATIONS
Final rule for regulations required in this section to
be issued not later than 180 days after June 10, 1993, see
section 165 of Pub. L. 103–43, set out as a note under section 289b of this title.

§ 289c. Research on public health emergencies
If the Secretary determines, after consultation with the Director of NIH, the Commissioner
of the Food and Drug Administration, or the Director of the Centers for Disease Control and
Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the Director of NIH—

Page 633

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) shall expedite the review by advisory
councils under section 284a of this title and by
peer review groups under section 289a of this
title of applications for grants for research on
such disease or disorder or proposals for contracts for such research;
(2) shall exercise the authority in section
6101 of title 41 respecting public exigencies to
waive the advertising requirements of such
section in the case of proposals for contracts
for such research;
(3) may provide administrative supplemental
increases in existing grants and contracts to
support new research relevant to such disease
or disorder; and
(4) shall disseminate, to health professionals
and the public, information on the cause, prevention, and treatment of such disease or disorder that has been developed in research assisted under this section.

§ 289d

REFERENCES IN TEXT
Subparts 14, 15 and 16 of part C, referred to in text,
are classified to sections 285n et seq., 285o et seq., and
285p et seq., respectively, of this title.
AMENDMENTS

The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half the original amount of the grant
or contract.

1999—Pub. L. 106–129, which directed the substitution
of ‘‘Agency for Healthcare Research and Quality’’ for
‘‘Agency for Health Care Policy and Research’’, was executed by making the substitution for ‘‘Agency for
Health Care Policy Research’’, to reflect the probable
intent of Congress.
1998—Pub. L. 105–362 struck out heading and designation of subsec. (a) and heading and text of subsec. (b).
Text of subsec. (b) read as follows: ‘‘Not later than December 30, 1993, and each December 30 thereafter, the
Secretary shall prepare and submit to the Committee
on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report concerning the activities carried out with the amounts referred to in subsection (a) of this section.’’
1995—Subsec. (b). Pub. L. 104–66 substituted ‘‘December 30, 1993, and each December 30 thereafter’’ for ‘‘September 30, 1993, and annually thereafter’’.
1993—Subsec. (b). Pub. L. 103–43 substituted ‘‘September 30, 1993’’ for ‘‘May 3, 1993’’.

(July 1, 1944, ch. 373, title IV, § 494, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875; amended
Pub. L. 102–531, title III, § 312(d)(9), Oct. 27, 1992,
106 Stat. 3504; Pub. L. 109–482, title I,
§ 104(b)(1)(P), Jan. 15, 2007, 120 Stat. 3693.)

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

CODIFICATION
In par. (2), ‘‘section 6101 of title 41’’ substituted for
‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’ on
authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
2007—Pub. L. 109–482 struck out subsec. (a) designation before ‘‘If the Secretary’’ and subsec. (b) which
read as follows: ‘‘Not later than 90 days after the end
of a fiscal year, the Secretary shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human
Resources of the Senate on actions taken under subsection (a) of this section in such fiscal year.’’
1992—Subsec. (a). Pub. L. 102–531 substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 289c–1. Collaborative use of certain health services research funds
The Secretary shall ensure that amounts
made available under subparts 14, 15 and 16 of
part C for health services research relating to
alcohol abuse and alcoholism, drug abuse and
mental health be used collaboratively, as appropriate, and in consultation with the Agency for
Healthcare Research and Quality.
(July 1, 1944, ch. 373, title IV, § 494A, as added
Pub. L. 102–321, title I, § 125, July 10, 1992, 106
Stat. 366; amended Pub. L. 103–43, title XX,
§ 2016(c), June 10, 1993, 107 Stat. 218; Pub. L.
104–66, title I, § 1062(b), Dec. 21, 1995, 109 Stat. 720;
Pub. L. 105–362, title VI, § 601(a)(1)(F), Nov. 10,
1998, 112 Stat. 3285; Pub. L. 106–129, § 2(b)(2), Dec.
6, 1999, 113 Stat. 1670.)

EFFECTIVE DATE

§ 289d. Animals in research
(a) Establishment of guidelines
The Secretary, acting through the Director of
NIH, shall establish guidelines for the following:
(1) The proper care of animals to be used in
biomedical and behavioral research.
(2) The proper treatment of animals while
being used in such research. Guidelines under
this paragraph shall require—
(A) the appropriate use of tranquilizers,
analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and
(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care
for animals in such research.
Such guidelines shall not be construed to prescribe methods of research.
(3) The organization and operation of animal
care committees in accordance with subsection (b) of this section.
(b) Animal care committees; establishment; membership; functions
(1) Guidelines of the Secretary under subsection (a)(3) of this section shall require animal
care committees at each entity which conducts
biomedical and behavioral research with funds
provided under this chapter (including the National Institutes of Health and the national research institutes) to assure compliance with the
guidelines established under subsection (a) of
this section.
(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established,
shall be composed of not fewer than three members, and shall include at least one individual
who has no association with such entity and at
least one doctor of veterinary medicine.

§ 289e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Each animal care committee of a research
entity shall—
(A) review the care and treatment of animals in all animal study areas and facilities of
the research entity at least semi-annually to
evaluate compliance with applicable guidelines established under subsection (a) of this
section for appropriate animal care and treatment;
(B) keep appropriate records of reviews conducted under subparagraph (A); and
(C) for each review conducted under subparagraph (A), file with the Director of NIH at
least annually (i) a certification that the review has been conducted, and (ii) reports of
any violations of guidelines established under
subsection (a) of this section or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the
research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority views filed by members of
the committee.
(c) Assurances required in application or contract proposal; reasons for use of animals;
notice and comment requirements for promulgation of regulations
The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health
or any national research institute to include in
its application or contract proposal, submitted
after the expiration of the twelve-month period
beginning on November 20, 1985—
(1) assurances satisfactory to the Director of
NIH that—
(A) the applicant meets the requirements
of the guidelines established under paragraphs (1) and (2) of subsection (a) of this
section and has an animal care committee
which meets the requirements of subsection
(b) of this section; and
(B) scientists, animal technicians, and
other personnel involved with animal care,
treatment, and use by the applicant have
available to them instruction or training in
the humane practice of animal maintenance
and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit
animal distress; and
(2) a statement of the reasons for the use of
animals in the research to be conducted with
funds provided under such grant or contract.
Notwithstanding subsection (a)(2) of section 553
of title 5, regulations under this subsection shall
be promulgated in accordance with the notice
and comment requirements of such section.
(d) Failure to meet guidelines; suspension or revocation of grant or contract
If the Director of NIH determines that—
(1) the conditions of animal care, treatment,
or use in an entity which is receiving a grant,
contract, or cooperative agreement involving
research on animals under this subchapter do
not meet applicable guidelines established
under subsection (a) of this section;

Page 634

(2) the entity has been notified by the Director of NIH of such determination and has been
given a reasonable opportunity to take corrective action; and
(3) no action has been taken by the entity to
correct such conditions;
the Director of NIH shall suspend or revoke such
grant or contract under such conditions as the
Director determines appropriate.
(e) Disclosure of trade secrets or privileged or
confidential information
No guideline or regulation promulgated under
subsection (a) or (c) of this section may require
a research entity to disclose publicly trade secrets or commercial or financial information
which is privileged or confidential.
(July 1, 1944, ch. 373, title IV, § 495, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875.)
PROHIBITION ON FUNDING OF PROJECTS INVOLVING USE
OF CHIMPANZEES OBTAINED FROM THE WILD
Pub. L. 102–394, title II, § 213, Oct. 6, 1992, 106 Stat.
1812, provided that: ‘‘No funds appropriated under this
Act or subsequent Departments of Labor, Health and
Human Services, and Education, and Related Agencies
Appropriations Acts shall be used by the National Institutes of Health, or any other Federal agency, or recipient of Federal funds on any project that entails the
capture or procurement of chimpanzees obtained from
the wild. For purposes of this section, the term ‘recipient of Federal funds’ includes private citizens, corporations, or other research institutions located outside of
the United States that are recipients of Federal funds.’’
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 102–170, title II, § 213, Nov. 26, 1991, 105 Stat.
1127.
Pub. L. 101–517, title II, § 211, Nov. 5, 1990, 104 Stat.
2209.
Pub. L. 101–166, title II, § 214, Nov. 21, 1989, 103 Stat.
1178.
PLAN FOR RESEARCH INVOLVING ANIMALS
Section 4 of Pub. L. 99–158 directed Director of National Institutes of Health to establish, not later than
Oct. 1, 1986, a plan for research into methods of biomedical research and experimentation which reduces
the use of animals in research or which produce less
pain and distress in animals to develop methods found
to be valid and reliable, to train scientists in use of
such methods, to disseminate information on such
methods and to establish an Interagency Coordinating
Committee to assist in development of the plan, prior
to repeal by Pub. L. 103–43, title II, § 205(b), June 10,
1993, 107 Stat. 148. See section 283e of this title.

§ 289e. Use of appropriations
(a) Appropriations to carry out the purposes of
this subchapter, unless otherwise expressly provided, may be expended in the District of Columbia for—
(1) personal services;
(2) stenographic recording and translating
services;
(3) travel expenses (including the expenses of
attendance at meetings when specifically authorized by the Secretary);
(4) rental;
(5) supplies and equipment;
(6) purchase and exchange of medical books,
books of reference, directories, periodicals,
newspapers, and press clippings;
(7) purchase, operation, and maintenance of
passenger motor vehicles;

Page 635

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(8) printing and binding (in addition to that
otherwise provided by law); and
(9) all other necessary expenses in carrying
out this subchapter.
Such appropriations may be expended by contract if deemed necessary, without regard to
section 6101 of title 41.
(b)(1) None of the amounts appropriated under
this chapter for the purposes of this subchapter
may be obligated for the construction of facilities (including the acquisition of land) unless a
provision of this subchapter establishes express
authority for such purpose and unless the Act
making appropriations under such provision
specifies that the amounts appropriated are
available for such purpose.
(2) Any grants, cooperative agreements, or
contracts authorized in this subchapter for the
construction of facilities may be awarded only
on a competitive basis.
(July 1, 1944, ch. 373, title IV, § 496, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended
Pub. L. 101–190, § 8, Nov. 29, 1989, 103 Stat. 1695;
Pub. L. 103–43, title XX, § 2008(b)(15), June 10,
1993, 107 Stat. 211.)
CODIFICATION
In subsec. (a), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
1993—Subsec. (a). Pub. L. 103–43 substituted ‘‘Appropriations to carry out the purposes of this subchapter’’
for ‘‘Such appropriations’’.
1989—Subsec. (a). Pub. L. 101–190 designated existing
provisions as subsec. (a), struck out first sentence
which read as follows: ‘‘Appropriations to carry out the
purposes of this subchapter shall be available for the
acquisition of land or the erection of buildings only if
so specified.’’, and added subsec. (b).
CONSTRUCTION OF BIOMEDICAL FACILITIES FOR DEVELOPMENT AND BREEDING OF SPECIALIZED STRAINS OF
MICE
Sections 1 to 7 of Pub. L. 101–190, as amended by Pub.
L. 101–374, § 4(a), (c)(1), Aug. 15, 1990, 104 Stat. 458, 459,
authorized a reservation of funds for making a grant to
construct facilities for development and breeding of
specialized strains of mice for use in biomedical research, provided for a competitive grant award process,
required applicant for the grant to agree to a twentyyear transferable obligation, restricted grant applicant
to public or nonprofit private status, with assurances
of sufficient financial resources, set forth other grant
requirements, and specified consequences of failure to
comply with agreements and violation of the twentyyear obligation.

§ 289f. Gifts and donations; memorials
The Secretary may, in accordance with section 238 of this title, accept conditional gifts for
the National Institutes of Health or a national
research institute or for the acquisition of
grounds or for the erection, equipment, or maintenance of facilities for the National Institutes
of Health or a national research institute. Donations of $50,000 or over for the National Institutes of Health or a national research institute
for carrying out the purposes of this subchapter
may be acknowledged by the establishment

§ 289g

within the National Institutes of Health or a national research institute of suitable memorials
to the donors.
(July 1, 1944, ch. 373, title IV, § 497, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended
Pub. L. 99–660, title III, § 311(b)(1), Nov. 14, 1986,
100 Stat. 3779; Pub. L. 100–607, title II, § 204(3),
Nov. 4, 1988, 102 Stat. 3079; Pub. L. 100–690, title
II, § 2620(b)(2), Nov. 18, 1988, 102 Stat. 4244; Pub.
L. 101–381, title I, § 102(5), Aug. 18, 1990, 104 Stat.
586; Pub. L. 103–43, title XX, § 2010(b)(6), June 10,
1993, 107 Stat. 214.)
AMENDMENTS
1993—Pub. L. 103–43 substituted ‘‘section 238’’ for
‘‘section 300aaa’’.
1990—Pub. L. 101–381 made technical amendment to
reference to section 300aaa of this title to reflect renumbering of corresponding section of original act.
1988—Pub. L. 100–690 made technical amendment to
reference to section 300aaa of this title to reflect renumbering of corresponding section of original act.
Pub. L. 100–607 substituted ‘‘300aaa’’ for ‘‘300cc’’.
1986—Pub. L. 99–660 substituted ‘‘section 300cc of this
title’’ for ‘‘section 300aa of this title’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Dec. 22, 1987,
see section 323 of Pub. L. 99–660, as amended, set out as
an Effective Date note under section 300aa–1 of this
title.

§ 289g. Fetal research
(a) Conduct or support by Secretary; restrictions
The Secretary may not conduct or support any
research or experimentation, in the United
States or in any other country, on a nonviable
living human fetus ex utero or a living human
fetus ex utero for whom viability has not been
ascertained unless the research or experimentation—
(1) may enhance the well-being or meet the
health needs of the fetus or enhance the probability of its survival to viability; or
(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of
the research or experimentation is the development of important biomedical knowledge
which cannot be obtained by other means.
(b) Risk standard for fetuses intended to be
aborted and fetuses intended to be carried to
term to be same
In administering the regulations for the protection of human research subjects which—
(1) apply to research conducted or supported
by the Secretary;
(2) involve living human fetuses in utero;
and
(3) are published in section 46.208 of part 46
of title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any
successor to such regulations) be the same for
fetuses which are intended to be aborted and fetuses which are intended to be carried to term.

§ 289g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title IV, § 498, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended
Pub. L. 100–607, title I, §§ 156, 157(b), Nov. 4, 1988,
102 Stat. 3059; Pub. L. 103–43, title I, § 121(b)(1),
June 10, 1993, 107 Stat. 133.)
AMENDMENTS
1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c)
which directed Biomedical Ethics Advisory Committee
to conduct a study of the nature, advisability, and biomedical and ethical implications of exercising any
waiver of the risk standard published in section
46.102(g) of part 46 of title 45 of the Code of Federal Regulations and to report its finding to the Biomedical
Ethics Board not later than 24 months after Nov. 4,
1988, which report was to be then transmitted to specified Congressional committees.
1988—Subsec. (c)(1). Pub. L. 100–607, § 157(b), substituted ‘‘24 months after November 4, 1988’’ for ‘‘thirty
months after November 20, 1985’’.
Subsec. (c)(2). Pub. L. 100–607, § 156(1), substituted ‘‘24month period beginning on November 4, 1988’’ for ‘‘thirty-six month period beginning on November 20, 1985’’.
Subsec. (c)(3). Pub. L. 100–607, § 156(2), substituted
‘‘1990’’ for ‘‘1988’’.
NULLIFICATION OF CERTAIN PROVISIONS
Section 121(c) of Pub. L. 103–43 provided that: ‘‘The
provisions of Executive Order 12806 (57 Fed. Reg. 21589
(May 21, 1992)) [formerly set out below] shall not have
any legal effect. The provisions of section 204(d) of part
46 of title 45 of the Code of Federal Regulations (45 CFR
46.204(d)) shall not have any legal effect.’’
EXECUTIVE ORDER NO. 12806. ESTABLISHMENT OF FETAL
TISSUE BANK
Ex. Ord. No. 12806, May 19, 1992, 57 F.R. 21589, which
established a human fetal tissue bank, was nullified by
Pub. L. 103–43, title I, § 121(c), June 10, 1993, 107 Stat.
133, set out above.
FEDERAL FUNDING OF FETAL TISSUE TRANSPLANTATION
RESEARCH
Memorandum of President of the United States, Jan.
22, 1993, 58 F.R. 7457, provided:
Memorandum for the Secretary of Health and Human
Services
On March 22, 1988, the Assistant Secretary for Health
of Health and Human Services (‘‘HHS’’) imposed a temporary moratorium on Federal funding of research involving transplantation of fetal tissue from induced
abortions. Contrary to the recommendations of a National Institutes of Health advisory panel, on November 2, 1989, the Secretary of Health and Human Services
extended the moratorium indefinitely. This moratorium has significantly hampered the development of
possible treatments for individuals afflicted with serious diseases and disorders, such as Parkinson’s disease,
Alzheimer’s disease, diabetes, and leukemia. Accordingly, I hereby direct that you immediately lift the
moratorium.
You are hereby authorized and directed to publish
this memorandum in the Federal Register.
WILLIAM J. CLINTON.

§ 289g–1. Research on transplantation of fetal tissue
(a) Establishment of program
(1) In general
The Secretary may conduct or support research on the transplantation of human fetal
tissue for therapeutic purposes.
(2) Source of tissue
Human fetal tissue may be used in research
carried out under paragraph (1) regardless of

Page 636

whether the tissue is obtained pursuant to a
spontaneous or induced abortion or pursuant
to a stillbirth.
(b) Informed consent of donor
(1) In general
In research carried out under subsection (a)
of this section, human fetal tissue may be
used only if the woman providing the tissue
makes a statement, made in writing and
signed by the woman, declaring that—
(A) the woman donates the fetal tissue for
use in research described in subsection (a) of
this section;
(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and
(C) the woman has not been informed of
the identity of any such individuals.
(2) Additional statement
In research carried out under subsection (a)
of this section, human fetal tissue may be
used only if the attending physician with respect to obtaining the tissue from the woman
involved makes a statement, made in writing
and signed by the physician, declaring that—
(A) in the case of tissue obtained pursuant
to an induced abortion—
(i) the consent of the woman for the
abortion was obtained prior to requesting
or obtaining consent for a donation of the
tissue for use in such research;
(ii) no alteration of the timing, method,
or procedures used to terminate the pregnancy was made solely for the purposes of
obtaining the tissue; and
(iii) the abortion was performed in accordance with applicable State law;
(B) the tissue has been donated by the
woman in accordance with paragraph (1);
and
(C) full disclosure has been provided to the
woman with regard to—
(i) such physician’s interest, if any, in
the research to be conducted with the tissue; and
(ii) any known medical risks to the
woman or risks to her privacy that might
be associated with the donation of the tissue and that are in addition to risks of
such type that are associated with the
woman’s medical care.
(c) Informed consent of researcher and donee
In research carried out under subsection (a) of
this section, human fetal tissue may be used
only if the individual with the principal responsibility for conducting the research involved
makes a statement, made in writing and signed
by the individual, declaring that the individual—
(1) is aware that—
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion
or pursuant to a stillbirth; and
(C) the tissue was donated for research
purposes;
(2) has provided such information to other
individuals with responsibilities regarding the
research;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) will require, prior to obtaining the consent of an individual to be a recipient of a
transplantation of the tissue, written acknowledgment of receipt of such information
by such recipient; and
(4) has had no part in any decisions as to the
timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.
(d) Availability of statements for audit
(1) In general
In research carried out under subsection (a)
of this section, human fetal tissue may be
used only if the head of the agency or other
entity conducting the research involved certifies to the Secretary that the statements required under subsections (b)(2) and (c) of this
section will be available for audit by the Secretary.
(2) Confidentiality of audit
Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a
confidential manner to protect the privacy
rights of the individuals and entities involved
in such research, including such individuals
and entities involved in the donation, transfer,
receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall—
(A) use such material or information only
for the purposes of verifying compliance
with the requirements of this section;
(B) not disclose or publish such material
or information, except where required by
Federal law, in which case such material or
information shall be coded in a manner such
that the identities of such individuals and
entities are protected; and
(C) not maintain such material or information after completion of such audit, except
where necessary for the purposes of such
audit.
(e) Applicability of State and local law
(1) Research conducted by recipients of assistance
The Secretary may not provide support for
research under subsection (a) of this section
unless the applicant for the financial assistance involved agrees to conduct the research
in accordance with applicable State law.
(2) Research conducted by Secretary
The Secretary may conduct research under
subsection (a) of this section only in accordance with applicable State and local law.
(f) Report
The Secretary shall annually submit to the
Committee on Energy and Commerce of the
House of Representatives, and to the Committee
on Labor and Human Resources of the Senate, a
report describing the activities carried out
under this section during the preceding fiscal
year, including a description of whether and to
what extent research under subsection (a) of this
section has been conducted in accordance with
this section.
(g) ‘‘Human fetal tissue’’ defined
For purposes of this section, the term ‘‘human
fetal tissue’’ means tissue or cells obtained from

§ 289g–1

a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
(July 1, 1944, ch. 373, title IV, § 498A, as added
Pub. L. 103–43, title I, § 111, June 10, 1993, 107
Stat. 129.)
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
NULLIFICATION OF MORATORIUM
Section 113 of Pub. L. 103–43 provided that:
‘‘(a) IN GENERAL.—Except as provided in subsection
(c), no official of the executive branch may impose a
policy that the Department of Health and Human Services is prohibited from conducting or supporting any
research on the transplantation of human fetal tissue
for therapeutic purposes. Such research shall be carried
out in accordance with section 498A of the Public
Health Service Act [this section] (as added by section
111 of this Act), without regard to any such policy that
may have been in effect prior to the date of the enactment of this Act [June 10, 1993].
‘‘(b) PROHIBITION AGAINST WITHHOLDING OF FUNDS IN
CASES OF TECHNICAL AND SCIENTIFIC MERIT.—
‘‘(1) IN GENERAL.—Subject to subsection (b)(2) of
section 492A of the Public Health Service Act [section
289a–1(b)(2) of this title] (as added by section 101 of
this Act), in the case of any proposal for research on
the transplantation of human fetal tissue for therapeutic purposes, the Secretary of Health and Human
Services may not withhold funds for the research if—
‘‘(A) the research has been approved for purposes
of subsection (a) of such section 492A;
‘‘(B) the research will be carried out in accordance with section 498A of such Act [this section] (as
added by section 111 of this Act); and
‘‘(C) there are reasonable assurances that the research will not utilize any human fetal tissue that
has been obtained in violation of section 498B(a) of
such Act [section 289g–2(a) of this title] (as added
by section 112 of this Act).
‘‘(2) STANDING APPROVAL REGARDING ETHICAL
STATUS.—In the case of any proposal for research on
the transplantation of human fetal tissue for therapeutic purposes, the issuance in December 1988 of the
Report of the Human Fetal Tissue Transplantation
Research Panel shall be deemed to be a report—
‘‘(A) issued by an ethics advisory board pursuant
to section 492A(b)(5)(B)(ii) of the Public Health
Service Act (as added by section 101 of this Act);
and
‘‘(B) finding, on a basis that is neither arbitrary
nor capricious, that the nature of the research is
such that it is not unethical to conduct or support
the research.
‘‘(c) AUTHORITY FOR WITHHOLDING FUNDS FROM RESEARCH.—In the case of any research on the transplantation of human fetal tissue for therapeutic purposes,
the Secretary of Health and Human Services may withhold funds for the research if any of the conditions
specified in any of subparagraphs (A) through (C) of
subsection (b)(1) are not met with respect to the research.

§ 289g–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(d) DEFINITION.—For purposes of this section, the
term ‘human fetal tissue’ has the meaning given such
term in section 498A(f) of the Public Health Service Act
[subsec. (f) of this section] (as added by section 111 of
this Act).’’
REPORT BY GENERAL ACCOUNTING OFFICE ON ADEQUACY
OF REQUIREMENTS
Section 114 of Pub. L. 103–43 provided that, with respect to research on the transplantation of human fetal
tissue for therapeutic purposes, the Comptroller General of the United States was to conduct an audit for
the purpose of determining whether and to what extent
such research conducted or supported by Secretary of
Health and Human Services had been conducted in accordance with this section and whether and to what extent there have been violations of section 289g–2 of this
title and directed the Comptroller General to complete
the audit and report the findings to Congress, not later
than May 19, 1995.

§ 289g–2. Prohibitions regarding human fetal tissue
(a) Purchase of tissue
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any
human fetal tissue for valuable consideration if
the transfer affects interstate commerce.
(b) Solicitation or acceptance of tissue as directed donation for use in transplantation
It shall be unlawful for any person to solicit or
knowingly acquire, receive, or accept a donation
of human fetal tissue for the purpose of transplantation of such tissue into another person if
the donation affects interstate commerce, the
tissue will be or is obtained pursuant to an induced abortion, and—
(1) the donation will be or is made pursuant
to a promise to the donating individual that
the donated tissue will be transplanted into a
recipient specified by such individual;
(2) the donated tissue will be transplanted
into a relative of the donating individual; or
(3) the person who solicits or knowingly acquires, receives, or accepts the donation has
provided valuable consideration for the costs
associated with such abortion.
(c) Solicitation or acceptance of tissue from fetuses gestated for research purposes
It shall be unlawful for any person or entity
involved or engaged in interstate commerce to—
(1) solicit or knowingly acquire, receive, or
accept a donation of human fetal tissue knowing that a human pregnancy was deliberately
initiated to provide such tissue; or
(2) knowingly acquire, receive, or accept tissue or cells obtained from a human embryo or
fetus that was gestated in the uterus of a
nonhuman animal.
(d) Criminal penalties for violations
(1) In general
Any person who violates subsection (a), (b),
or (c) shall be fined in accordance with title 18,
subject to paragraph (2), or imprisoned for not
more than 10 years, or both.
(2) Penalties applicable to persons receiving
consideration
With respect to the imposition of a fine
under paragraph (1), if the person involved vio-

Page 638

lates subsection (a) or (b)(3), a fine shall be imposed in an amount not less than twice the
amount of the valuable consideration received.
(e) Definitions
For purposes of this section:
(1) The term ‘‘human fetal tissue’’ has the
meaning given such term in section 289g–1(g)
of this title.
(2) The term ‘‘interstate commerce’’ has the
meaning given such term in section 321(b) of
title 21.
(3) The term ‘‘valuable consideration’’ does
not include reasonable payments associated
with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
(July 1, 1944, ch. 373, title IV, § 498B, as added
Pub. L. 103–43, title I, § 112, June 10, 1993, 107
Stat. 131; amended Pub. L. 109–242, § 2, July 19,
2006, 120 Stat. 570.)
AMENDMENTS
2006—Subsec. (c). Pub. L. 109–242, § 2(2), added subsec.
(c). Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 109–242, § 2(1), (3), redesignated
subsec. (c) as (d) and substituted ‘‘(a), (b), or (c)’’ for
‘‘(a) or (b)’’ in par. (1). Former subsec. (d) redesignated
(e).
Subsec. (e). Pub. L. 109–242, § 2(1), (4), redesignated
subsec. (d) as (e) and substituted ‘‘section 289g–1(g)’’ for
‘‘section 289g–1(f)’’ in par. (1).

§ 289g–3. Breast implant research
(a) In general
The Director of NIH may conduct or support
research to examine the long-term health implications of silicone breast implants, both gel and
saline filled. Such research studies may include
the following:
(1) Developing and examining techniques to
measure concentrations of silicone in body
fluids and tissues.
(2) Surveillance of recipients of silicone
breast implants, including long-term outcomes and local complications.
(b) Definition
For purposes of this section, the term ‘‘breast
implant’’ means a breast prosthesis that is implanted to augment or reconstruct the female
breast.
(July 1, 1944, ch. 373, title IV, § 498C, as added
Pub. L. 107–250, title II, § 215(b), Oct. 26, 2002, 116
Stat. 1615.)
BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL
Pub. L. 107–250, title II, § 214, Oct. 26, 2002, 116 Stat.
1615, which provided that the Comptroller General was
to conduct a study of information typically provided by
health professionals to women on breast implant surgery and to report the findings of the study to Congress, was repealed by Pub. L. 111–8, div. G, title I,
§ 1301(g), Mar. 11, 2009, 123 Stat. 829.

§ 289g–4. Support for emergency medicine research
(a) Emergency medical research
The Secretary shall support Federal programs
administered by the National Institutes of
Health, the Agency for Healthcare Research and

Page 639

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Quality, the Health Resources and Services Administration, the Centers for Disease Control
and Prevention, and other agencies involved in
improving the emergency care system to expand
and accelerate research in emergency medical
care systems and emergency medicine, including—
(1) the basic science of emergency medicine;
(2) the model of service delivery and the
components of such models that contribute to
enhanced patient health outcomes;
(3) the translation of basic scientific research into improved practice; and
(4) the development of timely and efficient
delivery of health services.
(b) Pediatric emergency medical research
The Secretary shall support Federal programs
administered by the National Institutes of
Health, the Agency for Healthcare Research and
Quality, the Health Resources and Services Administration, the Centers for Disease Control
and Prevention, and other agencies to coordinate and expand research in pediatric emergency medical care systems and pediatric emergency medicine, including—
(1) an examination of the gaps and opportunities in pediatric emergency care research
and a strategy for the optimal organization
and funding of such research;
(2) the role of pediatric emergency services
as an integrated component of the overall
health system;
(3) system-wide pediatric emergency care
planning, preparedness, coordination, and
funding;
(4) pediatric training in professional education; and
(5) research in pediatric emergency care,
specifically on the efficacy, safety, and health
outcomes of medications used for infants, children, and adolescents in emergency care settings in order to improve patient safety.
(c) Impact research
The Secretary shall support research to determine the estimated economic impact of, and
savings that result from, the implementation of
coordinated emergency care systems.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title IV, § 498D, as added
Pub. L. 111–148, title III, § 3504(b), Mar. 23, 2010,
124 Stat. 521.)
§ 289h. Repealed. Pub. L. 103–43, title
§ 121(b)(2), June 10, 1993, 107 Stat. 133

I,

Section, act July 1, 1944, ch. 373, title IV, § 499, as
added Nov. 20, 1985, Pub. L. 99–158, § 2, 99 Stat. 878, related to construction of subchapter.

§ 290. National Institutes of Health Management
Fund; establishment; advancements; availability; final adjustments of advances
For the purpose of facilitating the economical
and efficient conduct of operations in the National Institutes of Health which are financed
by two or more appropriations where the costs

§ 290a

of operation are not readily susceptible of distribution as charges to such appropriations,
there is established the National Institutes of
Health Management Fund. Such amounts as the
Director of the National Institutes of Health
may determine to represent a reasonable distribution of estimated costs among the various
appropriations involved may be advanced each
year to this fund and shall be available for expenditure for such costs under such regulations
as may be prescribed by said Director, including
the operation of facilities for the sale of meals
to employees and others at rates to be determined by said Director to be sufficient to cover
the reasonable value of the meals served and the
proceeds thereof shall be deposited to the credit
of this fund: Provided, That funds advanced to
this fund shall be available only in the fiscal
year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected
wherever practicable with the appropriations
from which such funds are advanced.
(Pub. L. 85–67, title II, § 201, June 29, 1957, 71
Stat. 220; Pub. L. 87–290, title II, § 201, Sept. 22,
1961, 75 Stat. 603.)
CODIFICATION
Section was enacted as a part of the Department of
Health, Education, and Welfare Appropriation Act,
1958, and not as a part of the Public Health Service Act
which comprises this chapter.
AMENDMENTS
1961—Pub. L. 87–290 substituted ‘‘reasonable value of
the meals served’’ for ‘‘cost of such operation’’.

§ 290a. Victims of fire
(a) Research on burns, burn injuries, and rehabilitation
The Secretary of Health and Human Services
shall establish, within the National Institutes of
Health and in cooperation with the Director, an
expanded program of research on burns, treatment of burn injuries, and rehabilitation of victims of fires. The National Institutes of Health
shall—
(1) sponsor and encourage the establishment
throughout the Nation of twenty-five additional burn centers, which shall comprise separate hospital facilities providing specialized
burn treatment and including research and
teaching programs and twenty-five additional
burn units, which shall comprise specialized
facilities in general hospitals used only for
burn victims;
(2) provide training and continuing support
of specialists to staff the new burn centers and
burn units;
(3) sponsor and encourage the establishment
of ninety burn programs in general hospitals
which comprise staffs of burn injury specialists;
(4) provide special training in emergency
care for burn victims;
(5) augment sponsorship of research on burns
and burn treatment;
(6) administer and support a systematic program of research concerning smoke inhalation
injuries; and
(7) sponsor and support other research and
training programs in the treatment and rehabilitation of burn injury victims.

§ 290b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Authorization of appropriations
For purposes of this section, there are authorized to be appropriated not to exceed $5,000,000
for the fiscal year ending June 30, 1975 and not
to exceed $8,000,000 for the fiscal year ending
June 30, 1976.
(Pub. L. 93–498, § 19, Oct. 29, 1974, 88 Stat. 1547;
Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat.
695;
Pub.
L.
106–503,
title
I,
§ 110(a)(2)(B)(vii), Nov. 13, 2000, 114 Stat. 2302.)
CODIFICATION
Section was enacted as part of the Federal Fire Prevention and Control Act of 1974 (which is classified
principally to chapter 49 (§ 2201 et seq.) of Title 15), and
not as a part of the Public Health Service Act which
comprises this chapter.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–503 substituted ‘‘in cooperation with the Director’’ for ‘‘in cooperation with
the Secretary’’.
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a) pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
TRANSFER OF FUNCTIONS
For transfer of all functions, personnel, assets, components, authorities, grant programs, and liabilities of
the Federal Emergency Management Agency, including
the functions of the Under Secretary for Federal Emergency Management relating thereto, to the Federal
Emergency Management Agency, see section 315(a)(1)
of Title 6, Domestic Security.
For transfer of functions, personnel, assets, and liabilities of the Federal Emergency Management Agency, including the functions of the Director of the Federal Emergency Management Agency relating thereto,
to the Secretary of Homeland Security, and for treatment of related references, see former section 313(1) and
sections 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.
DEFINITIONS
For definition of terms used in this section, see section 2203 of Title 15, Commerce and Trade.

PART I—FOUNDATION FOR THE NATIONAL
INSTITUTES OF HEALTH
AMENDMENTS
1998—Pub. L. 105–392, title IV, § 418(1), Nov. 13, 1998, 112
Stat. 3591, substituted ‘‘Foundation for the National Institutes of Health’’ for ‘‘National Foundation for Biomedical Research’’ in part heading.
1993—Pub. L. 103–43, title I, § 141(a)(2), June 10, 1993,
107 Stat. 136, redesignated part H ‘‘National Foundation
for Biomedical Research’’ as I.

§ 290b. Establishment and duties of Foundation
(a) In general
The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to
be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the ‘‘Foundation’’). The Foundation
shall not be an agency or instrumentality of the
United States Government.

Page 640

(b) Purpose of Foundation
The purpose of the Foundation shall be to support the National Institutes of Health in its mission (including collection of funds for pediatric
pharmacologic research), and to advance collaboration with biomedical researchers from
universities, industry, and nonprofit organizations.
(c) Certain activities of Foundation
(1) In general
In carrying out subsection (b) of this section, the Foundation may solicit and accept
gifts, grants, and other donations, establish
accounts, and invest and expend funds in support of the following activities with respect to
the purpose described in such subsection:
(A) A program to provide and administer
endowed positions that are associated with
the research program of the National Institutes of Health. Such endowments may be
expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the
endowed positions.
(B) A program to provide and administer
fellowships and grants to research personnel
in order to work and study in association
with the National Institutes of Health. Such
fellowships and grants may include stipends,
travel, health insurance benefits and other
appropriate expenses. The recipients of fellowships shall be selected by the donors and
the Foundation upon the recommendation of
the National Institutes of Health employees
in the laboratory where the fellow would
serve, and shall be subject to the agreement
of the Director of the National Institutes of
Health and the Executive Director of the
Foundation.
(C) A program to collect funds for pediatric pharmacologic research and studies for
which the Secretary issues a certification in
the affirmative under section 355a(n)(1)(A) of
title 21).1
(D) Supplementary programs to provide
for—
(i) scientists of other countries to serve
in research capacities in the United States
in association with the National Institutes
of Health or elsewhere, or opportunities
for employees of the National Institutes of
Health or other public health officials in
the United States to serve in such capacities in other countries, or both;
(ii) the conduct and support of studies,
projects, and research, which may include
stipends, travel and other support for personnel in collaboration with national and
international non-profit and for-profit organizations;
(iii) the conduct and support of forums,
meetings, conferences, courses, and training workshops that may include undergraduate, graduate, post-graduate, and
post-doctoral accredited courses and the
maintenance of accreditation of such
1 So in original. The closing parenthesis probably should not
appear.

Page 641

TITLE 42—THE PUBLIC HEALTH AND WELFARE

courses by the Foundation at the State
and national level for college or continuing education credits or for degrees;
(iv) programs to support and encourage
teachers and students of science at all levels of education and programs for the general public which promote the understanding of science;
(v) programs for writing, editing, printing, publishing, and vending of books and
other materials; and
(vi) the conduct of other activities to
carry out and support the purpose described in subsection (b) of this section.
(E) The Cures Acceleration Network described in section 282d of this title.
(2) Fees
The Foundation may assess fees for the provision of professional, administrative and
management services by the Foundation in
amounts determined reasonable and appropriate by the Executive Director.
(3) Authority of Foundation
The Foundation shall be the sole entity responsible for carrying out the activities described in this subsection.
(d) Board of Directors
(1) Composition
(A) The Foundation shall have a Board of Directors (hereafter referred to in this section as
the ‘‘Board’’), which shall be composed of ex
officio and appointed members in accordance
with this subsection. All appointed members
of the Board shall be voting members.
(B) The ex officio members of the Board
shall be—
(i) the Chairman and ranking minority
member of the Subcommittee on Health and
the Environment (Committee on Energy and
Commerce) or their designees, in the case of
the House of Representatives;
(ii) the Chairman and ranking minority
member of the Committee on Labor and
Human Resources or their designees, in the
case of the Senate;
(iii) the Director of the National Institutes
of Health; and
(iv) the Commissioner of Food and Drugs.
(C) The ex officio members of the Board
under subparagraph (B) shall appoint to the
Board individuals from among a list of candidates to be provided by the National Academy of Science. Such appointed members shall
include—
(i) representatives of the general biomedical field;
(ii) representatives of experts in pediatric
medicine and research;
(iii) representatives of the general biobehavioral field, which may include experts
in biomedical ethics; and
(iv) representatives of the general public,
which may include representatives of affected industries.
(D)(i) Not later than 30 days after June 10,
1993, the Director of the National Institutes of
Health shall convene a meeting of the ex officio members of the Board to—

§ 290b

(I) incorporate the Foundation and establish the general policies of the Foundation
for carrying out the purposes of subsection
(b) of this section, including the establishment of the bylaws of the Foundation; and
(II) appoint the members of the Board in
accordance with subparagraph (C).
(ii) Upon the appointment of the appointed
members of the Board under clause (i)(II), the
terms of service as members of the Board of
the ex officio members of the Board described
in clauses (i) and (ii) of subparagraph (B) shall
terminate. The ex officio members of the
Board described in clauses (iii) and (iv) of subparagraph (B) shall continue to serve as ex
officio members of the Board.
(E) The agreement of not less than threefifths of the members of the ex officio members of the Board shall be required for the appointment of each member to the initial
Board.
(F) No employee of the National Institutes
of Health shall be appointed as a member of
the Board.
(G) The Board may, through amendments to
the bylaws of the Foundation, provide that the
number of appointed members of the Board
shall be greater than the number specified in
subparagraph (C).
(2) Chair
(A) The ex officio members of the Board
under paragraph (1)(B) shall designate an individual to serve as the initial Chair of the
Board.
(B) Upon the termination of the term of
service of the initial Chair of the Board, the
appointed members of the Board shall elect a
member of the Board to serve as the Chair of
the Board.
(3) Terms and vacancies
(A) The term of office of each member of the
Board appointed under paragraph (1)(C) shall
be 5 years, except that the terms of offices for
the initial appointed members of the Board
shall expire as determined by the ex officio
members and the Chair.
(B) Any vacancy in the membership of the
appointed members of the Board shall be filled
in accordance with the bylaws of the Foundation established in accordance with paragraph
(6), and shall not affect the power of the remaining appointed members to execute the duties of the Board.
(C) If a member of the Board does not serve
the full term applicable under subparagraph
(A), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(D) A member of the Board may continue to
serve after the expiration of the term of the
member until a successor is appointed.
(4) Compensation
Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in
carrying out the duties of the Board, as set
forth in the bylaws issued by the Board.

§ 290b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Meetings and quorum
A majority of the appointed members of the
Board shall constitute a quorum for purposes
of conducting the business of the Board.
(6) Certain bylaws
(A) In establishing bylaws under this subsection, the Board shall ensure that the following are provided for:
(i) Policies for the selection of the officers,
employees, agents, and contractors of the
Foundation.
(ii) Policies, including ethical standards,
for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of
the Foundation. Policies with respect to ethical standards shall ensure that officers, employees and agents of the Foundation (including members of the Board) avoid encumbrances that would result in a conflict of interest, including a financial conflict of interest or a divided allegiance. Such policies
shall include requirements for the provision
of information concerning any ownership or
controlling interest in entities related to the
activities of the Foundation by such officers,
employees and agents and their spouses and
relatives.
(iii) Policies for the conduct of the general
operations of the Foundation.
(iv) Policies for writing, editing, printing,
publishing, and vending of books and other
materials.
(B) In establishing bylaws under this subsection, the Board shall ensure that such bylaws (and activities carried out under the bylaws) do not—
(i) reflect unfavorably upon the ability of
the Foundation or the National Institutes of
Health to carry out its responsibilities or official duties in a fair and objective manner;
or
(ii) compromise, or appear to compromise,
the integrity of any governmental agency or
program, or any officer or employee involved
in such program.
(e) Incorporation
The initial members of the Board shall serve
as incorporators and shall take whatever actions necessary to incorporate the Foundation.
(f) Nonprofit status
The Foundation shall be considered to be a
corporation under section 501(c) of title 26, and
shall be subject to the provisions of such section.
(g) Executive Director
(1) In general
The Foundation shall have an Executive Director who shall be appointed by the Board
and shall serve at the pleasure of the Board.
The Executive Director shall be responsible
for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.
(2) Compensation
The rate of compensation of the Executive
Director shall be fixed by the Board.

Page 642

(h) Powers
In carrying out subsection (b) of this section,
the Foundation may—
(1) operate under the direction of its Board;
(2) adopt, alter, and use a corporate seal,
which shall be judicially noticed;
(3) provide for 1 or more officers, employees,
and agents, as may be necessary, define their
duties, and require surety bonds or make other
provisions against losses occasioned by acts of
such persons;
(4) hire, promote, compensate, and discharge
officers and employees of the Foundation, and
define the duties of the officers and employees;
(5) with the consent of any executive department or independent agency, use the information, services, staff, and facilities of such in
carrying out this section;
(6) sue and be sued in its corporate name,
and complain and defend in courts of competent jurisdiction;
(7) modify or consent to the modification of
any contract or agreement to which it is a
party or in which it has an interest under this
part;
(8) establish a process for the selection of
candidates for positions under subsection (c)
of this section;
(9) enter into contracts with public and private organizations for the writing, editing,
printing, and publishing of books and other
material;
(10) take such action as may be necessary to
obtain patents and licenses for devices and
procedures developed by the Foundation and
its employees;
(11) solicit, accept, hold, administer, invest,
and spend any gift, devise, or bequest of real
or personal property made to the Foundation;
(12) enter into such other contracts, leases,
cooperative agreements, and other transactions as the Executive Director considers
appropriate to conduct the activities of the
Foundation;
(13) appoint other groups of advisors as may
be determined necessary from time to time to
carry out the functions of the Foundation;
(14) enter into such other contracts, leases,
cooperative agreements, and other transactions as the Executive Director considers
appropriate to conduct the activities of the
Foundation; and
(15) exercise other powers as set forth in this
section, and such other incidental powers as
are necessary to carry out its powers, duties,
and functions in accordance with this part.
(i) Administrative control
No participant in the program established
under this part shall exercise any administrative control over any Federal employee.
(j) General provisions
(1) Foundation integrity
The members of the Board shall be accountable for the integrity of the operations of the
Foundation and shall ensure such integrity
through the development and enforcement of
criteria and procedures relating to standards
of conduct, financial disclosure statements,
conflict of interest rules, recusal and waiver

Page 643

TITLE 42—THE PUBLIC HEALTH AND WELFARE

rules, audits and other matter determined appropriate by the Board.
(2) Financial conflicts of interest
Any individual who is an officer, employee,
or member of the Board of the Foundation
may not (in accordance with policies and requirements developed under subsection (d)(6))
personally or substantially participate in the
consideration or determination by the Foundation of any matter that would directly or
predictably affect any financial interest of the
individual or a relative (as such term is defined in section 109(16) of the Ethics in Government Act of 1978) of the individual, of any
business organization or other entity, or of
which the individual is an officer or employee,
or is negotiating for employment, or in which
the individual has any other financial interest.
(3) Audits; availability of records
The Foundation shall—
(A) provide for annual audits of the financial condition of the Foundation; and
(B) make such audits, and all other
records, documents, and other papers of the
Foundation, available to the Secretary and
the Comptroller General of the United
States for examination or audit.
(4) Reports
(A) Not later than 5 months following the
end of each fiscal year, the Foundation shall
publish a report describing the activities of
the Foundation during the preceding fiscal
year. Each such report shall include for the
fiscal year involved a comprehensive statement of the operations, activities, financial
condition, and accomplishments of the Foundation, including an accounting of the use of
amounts transferred under subsection (l).
(B) With respect to the financial condition of
the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts or grants to the Foundation of real or personal property, and the
source and amount of all gifts or grants to the
Foundation of money. Each such report shall
include a specification of any restrictions on
the purposes for which gifts or grants to the
Foundation may be used.
(C) The Foundation shall make copies of
each report submitted under subparagraph (A)
available—
(i) for public inspection, and shall upon request provide a copy of the report to any individual for a charge that shall not exceed
the cost of providing the copy; and
(ii) to the appropriate committees of Congress.
(D) The Board shall annually hold a public
meeting to summarize the activities of the
Foundation and distribute written reports
concerning such activities and the scientific
results derived from such activities.
(5) Service of Federal employees
Federal employees may serve on committees
advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its function, so long as the employ-

§ 290b

ees do not direct or control Foundation activities.
(6) Relationship with existing entities
The Foundation may, pursuant to appropriate agreements, merge with, acquire, or use
the resources of existing nonprofit private corporations with missions similar to the purposes of the Foundation, such as the Foundation for Advanced Education in the Sciences.
(7) Intellectual property rights
The Board shall adopt written standards
with respect to the ownership of any intellectual property rights derived from the collaborative efforts of the Foundation prior to the
commencement of such efforts.
(8) National Institutes of Health Amendments
of 1990
The activities conducted in support of the
National Institutes of Health Amendments of
1990 (Public Law 101–613), and the amendments
made by such Act, shall not be nullified by the
enactment of this section.2
(9) Limitation of activities
(A) In general
The Foundation shall exist solely as an entity to work in collaboration with the research programs of the National Institutes
of Health. The Foundation may not undertake activities (such as the operation of
independent laboratories or competing for
Federal research funds) that are independent
of those of the National Institutes of Health
research programs.
(B) Gifts, grants, and other donations
(i) In general
Gifts, grants, and other donations to the
Foundation may be designated for pediatric research and studies on drugs, and
funds so designated shall be used solely for
grants for research and studies under subsection (c)(1)(C) of this section.
(ii) Other gifts
Other gifts, grants, or donations received
by the Foundation and not described in
clause (i) may also be used to support such
pediatric research and studies.
(iii) Report
The recipient of a grant for research and
studies shall agree to provide the Director
of the National Institutes of Health and
the Commissioner of Food and Drugs, at
the conclusion of the research and studies—
(I) a report describing the results of
the research and studies; and
(II) all data generated in connection
with the research and studies.
(iv) Action by the Commissioner of Food
and Drugs
The Commissioner of Food and Drugs
shall take appropriate action in response
to a report received under clause (iii) in
accordance with paragraphs (7) through
2 So

in original. Probably should be ‘‘subsection’’.

§ 290b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(12) 3 of section 284m(c) of this title, including negotiating with the holders of approved applications for the drugs studied
for any labeling changes that the Commissioner determines to be appropriate and
requests the holders to make.
(C) Applicability
Subparagraph (A) does not apply to the
program described in subsection (c)(1)(C) of
this section.
(10) Transfer of funds
The Foundation may transfer funds to the
National Institutes of Health and the National
Institutes of Health may accept transfers of
funds from the Foundation. Any funds transferred under this paragraph shall be subject to
all Federal limitations relating to federallyfunded research.
(k) Duties of Director
(1) Applicability of certain standards to nonFederal employees
In the case of any individual who is not an
employee of the Federal Government and who
serves in association with the National Institutes of Health, with respect to financial assistance received from the Foundation, the
Foundation may not provide the assistance of,
or otherwise permit the work at the National
Institutes of Health to begin until a memorandum of understanding between the individual
and the Director of the National Institutes of
Health, or the designee of such Director, has
been executed specifying that the individual
shall be subject to such ethical and procedural
standards of conduct relating to duties performed at the National Institutes of Health, as
the Director of the National Institutes of
Health determines is appropriate.
(2) Support services
The Director of the National Institutes of
Health may provide facilities, utilities and
support services to the Foundation if it is determined by the Director to be advantageous
to the research programs of the National Institutes of Health.
(l) Funding
From amounts appropriated to the National
Institutes of Health, for each fiscal year, the Director of NIH shall transfer not less than $500,000
and not more than $1,250,000 to the Foundation.
(July 1, 1944, ch. 373, title IV, § 499, formerly
§ 499A, as added Pub. L. 101–613, § 2, Nov. 16, 1990,
104 Stat. 3224; amended Pub. L. 102–170, title II,
§ 216, Nov. 26, 1991, 105 Stat. 1128; Pub. L. 102–321,
title I, § 163(b)(6), July 10, 1992, 106 Stat. 376; renumbered § 499 and amended Pub. L. 103–43, title
I, § 121(b)(3), title XVII, § 1701, June 10, 1993, 107
Stat. 133, 186; Pub. L. 104–316, title I, § 122(b), Oct.
19, 1996, 110 Stat. 3836; Pub. L. 105–392, title IV,
§ 418(2), Nov. 13, 1998, 112 Stat. 3591; Pub. L.
107–109, § 13, Jan. 4, 2002, 115 Stat. 1417; Pub. L.
109–482, title I, § 107, Jan. 15, 2007, 120 Stat. 3696;
Pub. L. 110–85, title V, § 502(c), Sept. 27, 2007, 121
Stat. 889; Pub. L. 111–148, title X, § 10409(c), Mar.
23, 2010, 124 Stat. 978.)
3 See

References in Text note below.

Page 644

REFERENCES IN TEXT
Section 109(16) of the Ethics in Government Act of
1978, referred to in subsec. (j)(2), is section 109(16) of
Pub. L. 95–521, which is set out in the Appendix to Title
5, Government Organization and Employees.
The National Institutes of Health Amendments of
1990, referred to in subsec. (j)(8), is Pub. L. 101–613, Nov.
16, 1990, 104 Stat. 3224, as amended, which enacted this
section, section 285g–4 of this title, and provisions set
out as notes under section 201 and 285g–4 of this title.
For complete classification of this Act to the Code, see
Short Title of 1990 Amendments note set out under section 201 of this title and Tables.
Section 284m of this title, referred to in subsec.
(j)(9)(B)(iv), was amended generally by Pub. L. 110–85,
title V, § 502(b), Sept. 27, 2007, 121 Stat. 886, and, as so
amended, does not contain a par. (12) in subsec. (c).
PRIOR PROVISIONS
A prior section 499 of act July 1, 1944, was classified
to section 289h of this title prior to repeal by Pub. L.
103–43.
AMENDMENTS
2010—Subsec. (c)(1)(E). Pub. L. 111–148 added subpar.
(E).
2007—Subsec. (c)(1)(C). Pub. L. 110–85 substituted ‘‘and
studies for which the Secretary issues a certification in
the affirmative under section 355a(n)(1)(A) of title 21’’
for ‘‘and studies listed by the Secretary pursuant to
section 284m(a)(1)(A) of this title and referred under
section 355a(d)(4)(C) of title 21’’. Amendment was executed as the probable intent of Congress, notwithstanding errors in the directory language in quoting the text
in the original to be stricken out.
Subsec. (d)(1)(D)(ii). Pub. L. 109–482, § 107(1)(A)(i),
amended cl. (ii) generally. Prior to amendment, cl. (ii)
read as follows: ‘‘Upon the appointment of the members
of the Board under clause (i)(II), the terms of service of
the ex officio members of the Board as members of the
Board shall terminate.’’
Subsec. (d)(1)(G). Pub. L. 109–482, § 107(1)(A)(ii), inserted ‘‘appointed’’ after ‘‘that the number of’’.
Subsec. (d)(3)(B). Pub. L. 109–482, § 107(1)(B), amended
subpar. (B) generally. Prior to amendment, subpar. (B)
read as follows: ‘‘Any vacancy in the membership of the
Board shall be filled in the manner in which the original position was made and shall not affect the power of
the remaining members to execute the duties of the
Board.’’
Subsec. (d)(5). Pub. L. 109–482, § 107(1)(C), inserted ‘‘appointed’’ after ‘‘majority of the’’.
Subsec. (j)(2). Pub. L. 109–482, § 107(2)(A), substituted
‘‘subsection (d)(6)’’ for ‘‘subsection (d)(2)(B)(i)(II)’’.
Subsec. (j)(4)(A). Pub. L. 109–482, § 107(2)(B)(i), inserted
‘‘, including an accounting of the use of amounts transferred under subsection (l)’’ before period at end.
Subsec. (j)(4)(C). Pub. L. 109–482, § 107(2)(B)(ii), added
subpar. (C) and struck out former subpar. (C) which
read as follows: ‘‘The Foundation shall make copies of
each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge
not exceeding the cost of providing the copy.’’
Subsec. (j)(10). Pub. L. 109–482, § 107(2)(C), substituted
‘‘of Health and the National Institutes of Health may
accept transfers of funds from the Foundation’’ for ‘‘of
Health’’.
Subsec. (l). Pub. L. 109–482, § 107(3), added subsec. (l)
and struck out former subsec. (l) which related to authorization of appropriations and limitation regarding
other funds.
2002—Subsec. (b). Pub. L. 107–109, § 13(1), inserted ‘‘(including collection of funds for pediatric pharmacologic
research)’’ after ‘‘mission’’.
Subsec. (c)(1)(C), (D). Pub. L. 107–109, § 13(2), added
subpar. (C) and redesignated former subpar. (C) as (D).
Subsec. (d)(1)(B)(iv). Pub. L. 107–109, § 13(3)(A)(i),
added cl. (iv).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (d)(1)(C). Pub. L. 107–109, § 13(3)(A)(ii), added
subpar. (C) and struck out former subpar. (C) which
read as follows: ‘‘The ex officio members of the Board
under subparagraph (B) shall appoint to the Board 11
individuals from among a list of candidates to be provided by the National Academy of Science. Of such appointed members—
‘‘(i) 4 shall be representative of the general biomedical field;
‘‘(ii) 2 shall be representatives of the general
biobehavorial field; and
‘‘(iii) 5 shall be representatives of the general public.’’
Subsec. (d)(2)(B). Pub. L. 107–109, § 13(3)(B), realigned
margin.
Subsec. (e) to (g). Pub. L. 107–109, § 13(5), redesignated
subsecs. (f) to (h) as (e) to (g), respectively.
Subsec. (h). Pub. L. 107–109, § 13(5), (6), redesignated
subsec. (i) as (h) and substituted ‘‘solicit,’’ for ‘‘solicit’’
in par. (11). Former subsec. (h) redesignated (g).
Subsec. (i). Pub. L. 107–109, § 13(5), redesignated subsec. (j) as (i). Former subsec. (i) redesignated (h).
Subsec. (j). Pub. L. 107–109, § 13(5), redesignated subsec. (k) as (j). Former subsec. (j) redesignated (i).
Subsec. (j)(1). Pub. L. 107–109, § 13(7), struck out ‘‘(including
those
developed
under
subsection
(d)(2)(B)(i)(II))’’ after ‘‘procedures relating to standards
of conduct’’.
Subsec. (j)(2). Pub. L. 107–109, § 13(7), which directed
striking out ‘‘(including those developed under subsection (d)(2)(B)(i)(II))’’ in par. (2), could not be executed because those words do not appear in par. (2).
Subsec. (k). Pub. L. 107–109, § 13(5), redesignated subsec. (l) as (k). Former subsec. (k) redesignated (j).
Subsec. (k)(9). Pub. L. 107–109, § 13(4), designated existing provisions as subpar. (A), inserted subpar. heading, and added subpars. (B) and (C).
Subsecs. (l), (m). Pub. L. 107–109, § 13(5), redesignated
subsec. (m) as (l). Former subsec. (l) redesignated (k).
1998—Subsec. (a). Pub. L. 105–392, § 418(2)(A), substituted ‘‘Foundation for the National Institutes of
Health’’ for ‘‘National Foundation for Biomedical Research’’.
Subsec. (k)(10). Pub. L. 105–392, § 418(2)(B), struck out
‘‘not’’ after ‘‘may’’ and inserted at end ‘‘Any funds
transferred under this paragraph shall be subject to all
Federal limitations relating to federally-funded research.’’
Subsec. (m)(1). Pub. L. 105–392, § 418(2)(C), substituted
‘‘$500,000 for each fiscal year’’ for ‘‘$200,000 for the fiscal
years 1994 and 1995’’.
1996—Subsec. (n). Pub. L. 104–316 struck out subsec.
(n) which required Comptroller General to conduct
audit and prepare report to Congress on adequacy of
compliance of the Foundation with guidelines established under this section.
1993—Subsec. (a). Pub. L. 103–43, § 1701(1), inserted
‘‘, acting through the Director of NIH,’’ after ‘‘Secretary shall’’ and struck out ‘‘, except for the purposes
of the Ethics in Government Act and the Technology
Transfer Act,’’ after ‘‘shall not’’.
Subsec. (b). Pub. L. 103–43, § 1701(3), added subsec. (b)
and struck out heading and text of former subsec. (b).
Text related to duties of Foundation.
Subsec. (c). Pub. L. 103–43, § 1701(3), added subsec. (c).
Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 103–43, § 1701(2), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (f).
Subsec. (d)(1). Pub. L. 103–43, § 1701(4)(A), substituted
‘‘appointed members of the Board’’ for ‘‘members of the
Foundation’’ in subpar. (A), ‘‘Board’’ for ‘‘Council’’ in
subpar. (B), and ‘‘appoint to the Board’’ for ‘‘appoint to
the Council’’ in subpar. (C), and added subpars. (D) to
(G).
Subsec. (d)(2). Pub. L. 103–43, § 1701(4)(B), designated
existing provisions as subpar. (A), substituted ‘‘an individual to serve as the initial Chair’’ for ‘‘an appointed
member of the Board to serve as the Chair’’, and added
subpar. (B).
Subsec. (d)(3)(A). Pub. L. 103–43, § 1701(4)(C), substituted ‘‘(1)(C)’’ for ‘‘(2)(C)’’.

§ 290b

Subsec. (d)(5), (6). Pub. L. 103–43, § 1701(4)(D), added
pars. (5) and (6).
Subsec. (e). Pub. L. 103–43, § 1701(2), redesignated subsec. (e) as (g).
Subsecs. (f) to (h). Pub. L. 103–43, § 1701(2), redesignated subsecs. (d) to (f) as (f) to (h), respectively.
Former subsecs. (g) and (h) redesignated (i) and (j), respectively.
Subsec. (i). Pub. L. 103–43, § 1701(2), redesignated subsec. (g) as (i). Former subsec. (i) redesignated (m).
Subsec. (i)(4). Pub. L. 103–43, § 1701(5)(A), inserted before period at end ‘‘, and define the duties of the officers and employees’’.
Subsec. (i)(5), (6). Pub. L. 103–43, § 1701(5)(B), (C), redesignated par. (6) as (5) and struck out former par. (5)
which read as follows: ‘‘prescribe by its Board its bylaws, that shall be consistent with law, and that shall
provide for the manner in which—
‘‘(A) its officers, employees, and agents are selected;
‘‘(B) its property is acquired, held, and transferred;
‘‘(C) its general operations are to be conducted; and
‘‘(D) the privileges granted by law are exercised and
enjoyed;’’.
Subsec. (i)(7). Pub. L. 103–43, § 1701(5)(C), (D), redesignated par. (8) as (7) and substituted ‘‘part’’ for ‘‘subtitle’’. Former par. (7) redesignated (6).
Subsec. (i)(8). Pub. L. 103–43, § 1701(5)(C), (E), redesignated par. (9) as (8) and substituted ‘‘establish a process
for the selection of candidates for positions under subsection (c) of this section’’ for ‘‘establish a mechanism
for the selection of candidates, subject to the approval
of the Director of the National Institutes of Health, for
the endowed scientific positions within the organizational structure of the intramural research programs of
the National Institutes of Health and candidates for
participation in the National Institutes of Health
Scholars program’’.
Subsec. (i)(9), (10). Pub. L. 103–43, § 1701(5)(C), redesignated pars. (10) and (11) as (9) and (10), respectively.
Former par. (9) redesignated (8).
Subsec. (i)(11). Pub. L. 103–43, § 1701(5)(C), (F), redesignated par. (12) as (11) and inserted ‘‘solicit’’ before ‘‘accept’’. Former par. (11) redesignated (10).
Subsec. (i)(12), (13). Pub. L. 103–43, § 1701(5)(C), redesignated pars. (13) and (14) as (12) and (13), respectively.
Former par. (12) redesignated (11).
Subsec. (i)(14). Pub. L. 103–43, § 1701(5)(G), (H), added
par. (14). Former par. (14) redesignated (13).
Subsec. (i)(15). Pub. L. 103–43, § 1701(5)(I), substituted
‘‘part’’ for ‘‘subtitle’’.
Subsec. (j). Pub. L. 103–43, § 1701(2), redesignated subsec. (h) as (j).
Subsecs. (k), (l). Pub. L. 103–43, § 1701(6), added subsecs. (k) and (l).
Subsec. (m). Pub. L. 103–43, § 1701(7), amended heading
and text of subsec. (m) generally. Prior to amendment,
text read as follows:
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—Subject to
paragraph (2), for the purpose of carrying out this part,
there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1991
through 1995.
‘‘(2) LIMITATIONS.—
‘‘(A) Amounts appropriated under paragraph (1) or
made available under subparagraph (C) may not be
provided to the fund established under subsection
(b)(1)(A) of this section.
‘‘(B) For the first fiscal year for which amounts are
appropriated under paragraph (1), $200,000 is authorized to be appropriated.
‘‘(C) With respect to the first fiscal year for which
amounts are appropriated under paragraph (1), the
Secretary may, from amounts appropriated for such
fiscal year for the programs of the Department of
Health and Human Services, make available not more
than $200,000 for carrying out this part, subject to
subparagraph (A).’’
Pub. L. 103–43, § 1701(2), redesignated subsec. (i) as
(m).

§ 290aa

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (n). Pub. L. 103–43, § 1701(8), added subsec. (n).
1992—Subsec. (g)(9). Pub. L. 102–321 struck out ‘‘or the
Administrator of the Alcohol, Drug Abuse, and Mental
Health Administration’’ after ‘‘Director of the National
Institutes of Health’’ and ‘‘and the Alcohol, Drug
Abuse, and Mental Health Administration’’ after ‘‘research programs of the National Institutes of Health’’.
1991—Subsec. (c)(1)(C). Pub. L. 102–170, § 216(1), substituted ‘‘11’’ for ‘‘9’’.
Subsec. (c)(1)(C)(iii). Pub. L. 102–170, § 216(2), substituted ‘‘5’’ for ‘‘3’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

SUBCHAPTER
III–A—SUBSTANCE
ABUSE
AND MENTAL HEALTH SERVICES ADMINISTRATION
PART A—ORGANIZATION AND GENERAL
AUTHORITIES
§ 290aa. Substance Abuse and Mental Health
Services Administration
(a) Establishment
The Substance Abuse and Mental Health Services Administration (hereafter referred to in
this subchapter as the ‘‘Administration’’) is an
agency of the Service.
(b) Agencies
The following entities are agencies of the Administration:
(1) The Center for Substance Abuse Treatment.
(2) The Center for Substance Abuse Prevention.
(3) The Center for Mental Health Services.
(c) Administrator and Deputy Administrator
(1) Administrator
The Administration shall be headed by an
Administrator (hereinafter in this subchapter
referred to as the ‘‘Administrator’’) who shall
be appointed by the President, by and with the
advice and consent of the Senate.
(2) Deputy Administrator
The Administrator, with the approval of the
Secretary, may appoint a Deputy Adminis-

Page 646

trator and may employ and prescribe the functions of such officers and employees, including
attorneys, as are necessary to administer the
activities to be carried out through the Administration.
(d) Authorities
The Secretary, acting through the Administrator, shall—
(1) supervise the functions of the agencies of
the Administration in order to assure that the
programs carried out through each such agency receive appropriate and equitable support
and that there is cooperation among the agencies in the implementation of such programs;
(2) establish and implement, through the respective agencies, a comprehensive program to
improve the provision of treatment and related services to individuals with respect to substance abuse and mental illness and to improve prevention services, promote mental
health and protect the legal rights of individuals with mental illnesses and individuals who
are substance abusers;
(3) carry out the administrative and financial management, policy development and
planning, evaluation, knowledge dissemination, and public information functions that
are required for the implementation of this
subchapter;
(4) assure that the Administration conduct
and coordinate demonstration projects, evaluations, and service system assessments and
other activities necessary to improve the
availability and quality of treatment, prevention and related services;
(5) support activities that will improve the
provision of treatment, prevention and related
services, including the development of national mental health and substance abuse
goals and model programs;
(6) in cooperation with the National Institutes of Health, the Centers for Disease Control and the Health Resources and Services
Administration develop educational materials
and intervention strategies to reduce the risks
of HIV or tuberculosis among substance abusers and individuals with mental illness and to
develop appropriate mental health services for
individuals with such illnesses;
(7) coordinate Federal policy with respect to
the provision of treatment services for substance abuse utilizing anti-addiction medications, including methadone;
(8) conduct programs, and assure the coordination of such programs with activities of the
National Institutes of Health and the Agency
for Healthcare Research and Quality, as appropriate, to evaluate the process, outcomes and
community impact of treatment and prevention services and systems of care in order to
identify the manner in which such services
can most effectively be provided;
(9) collaborate with the Director of the National Institutes of Health in the development
of a system by which the relevant research
findings of the National Institute on Drug
Abuse, the National Institute on Alcohol
Abuse and Alcoholism, the National Institute
of Mental Health, and, as appropriate, the
Agency for Healthcare Research and Quality

Page 647

TITLE 42—THE PUBLIC HEALTH AND WELFARE

are disseminated to service providers in a
manner designed to improve the delivery and
effectiveness of treatment and prevention
services;
(10) encourage public and private entities
that provide health insurance to provide benefits for substance abuse and mental health
services;
(11) promote the integration of substance
abuse and mental health services into the
mainstream of the health care delivery system
of the United States;
(12) monitor compliance by hospitals and
other facilities with the requirements of sections 290dd–1 and 290dd–2 of this title;
(13) with respect to grant programs authorized under this subchapter, assure that—
(A) all grants that are awarded for the provision of services are subject to performance
and outcome evaluations; and
(B) all grants that are awarded to entities
other than States are awarded only after the
State in which the entity intends to provide
services—
(i) is notified of the pendency of the
grant application; and
(ii) is afforded an opportunity to comment on the merits of the application;
(14) assure that services provided with
amounts appropriated under this subchapter
are provided bilingually, if appropriate;
(15) improve coordination among prevention
programs, treatment facilities and nonhealth
care systems such as employers, labor unions,
and schools, and encourage the adoption of
employee assistance programs and student assistance programs;
(16) maintain a clearinghouse for substance
abuse and mental health information to assure
the widespread dissemination of such information to States, political subdivisions, educational agencies and institutions, treatment
providers, and the general public;
(17) in collaboration with the National Institute on Aging, and in consultation with the
National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental
Health, as appropriate, promote and evaluate
substance abuse services for older Americans
in need of such services, and mental health
services for older Americans who are seriously
mentally ill; and
(18) promote the coordination of service programs conducted by other departments, agencies, organizations and individuals that are or
may be related to the problems of individuals
suffering from mental illness or substance
abuse, including liaisons with the Social Security Administration, Centers for Medicare &
Medicaid Services, and other programs of the
Department, as well as liaisons with the Department of Education, Department of Justice, and other Federal Departments and offices, as appropriate.
(e) Associate Administrator for Alcohol Prevention and Treatment Policy
(1) In general
There may be in the Administration an Associate Administrator for Alcohol Prevention

§ 290aa

and Treatment Policy to whom the Administrator may delegate the functions of promoting, monitoring, and evaluating service programs for the prevention and treatment of alcoholism and alcohol abuse within the Center
for Substance Abuse Prevention, the Center
for Substance Abuse Treatment and the Center for Mental Health Services, and coordinating such programs among the Centers, and
among the Centers and other public and private entities. The Associate Administrator
also may ensure that alcohol prevention, education, and policy strategies are integrated
into all programs of the Centers that address
substance abuse prevention, education, and
policy, and that the Center for Substance
Abuse Prevention addresses the Healthy People 2010 goals and the National Dietary Guidelines of the Department of Health and Human
Services and the Department of Agriculture
related to alcohol consumption.
(2) Plan
(A) The Administrator, acting through the
Associate Administrator for Alcohol Prevention and Treatment Policy, shall develop, and
periodically review and as appropriate revise,
a plan for programs and policies to treat and
prevent alcoholism and alcohol abuse. The
plan shall be developed (and reviewed and revised) in collaboration with the Directors of
the Centers of the Administration and in consultation with members of other Federal agencies and public and private entities.
(B) Not later than 1 year after July 10, 1992,
the Administrator shall submit to the Congress the first plan developed under subparagraph (A).
(3) Report
(A) Not less than once during each 2 years,
the Administrator, acting through the Associate Administrator for Alcohol Prevention and
Treatment Policy, shall prepare a report describing the alcoholism and alcohol abuse prevention and treatment programs undertaken
by the Administration and its agencies, and
the report shall include a detailed statement
of the expenditures made for the activities reported on and the personnel used in connection with such activities.
(B) Each report under subparagraph (A) shall
include a description of any revisions in the
plan under paragraph (2) made during the preceding 2 years.
(C) Each report under subparagraph (A) shall
be submitted to the Administrator for inclusion in the biennial report under subsection
(k) of this section.
(f) Associate Administrator for Women’s Services
(1) Appointment
The Administrator, with the approval of the
Secretary, shall appoint an Associate Administrator for Women’s Services who shall report
directly to the Administrator.
(2) Duties
The Associate Administrator appointed
under paragraph (1) shall—
(A) establish a committee to be known as
the Coordinating Committee for Women’s

§ 290aa

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Services (hereafter in this subparagraph referred to as the ‘‘Coordinating Committee’’),
which shall be composed of the Directors of
the agencies of the Administration (or the
designees of the Directors);
(B) acting through the Coordinating Committee, with respect to women’s substance
abuse and mental health services—
(i) identify the need for such services,
and make an estimate each fiscal year of
the funds needed to adequately support the
services;
(ii) identify needs regarding the coordination of services;
(iii) encourage the agencies of the Administration to support such services; and
(iv) assure that the unique needs of minority women, including Native American,
Hispanic, African-American and Asian
women, are recognized and addressed within the activities of the Administration;
and
(C) establish an advisory committee to be
known as the Advisory Committee for Women’s Services, which shall be composed of
not more than 10 individuals, a majority of
whom shall be women, who are not officers
or employees of the Federal Government, to
be appointed by the Administrator from
among physicians, practitioners, treatment
providers, and other health professionals,
whose clinical practice, specialization, or
professional expertise includes a significant
focus on women’s substance abuse and mental health conditions, that shall—
(i) advise the Associate Administrator
on appropriate activities to be undertaken
by the agencies of the Administration with
respect to women’s substance abuse and
mental health services, including services
which require a multidisciplinary approach;
(ii) collect and review data, including information provided by the Secretary (including the material referred to in paragraph (3)), and report biannually to the
Administrator regarding the extent to
which women are represented among senior personnel, and make recommendations
regarding improvement in the participation of women in the workforce of the Administration; and
(iii) prepare, for inclusion in the biennial
report required pursuant to subsection (k)
of this section, a description of activities
of the Committee, including findings made
by the Committee regarding—
(I) the extent of expenditures made for
women’s substance abuse and mental
health services by the agencies of the
Administration; and
(II) the estimated level of funding
needed for substance abuse and mental
health services to meet the needs of
women;
(D) improve the collection of data on women’s health by—
(i) reviewing the current data at the Administration to determine its uniformity
and applicability;

Page 648

(ii) developing standards for all programs funded by the Administration so
that data are, to the extent practicable,
collected and reported using common reporting formats, linkages and definitions;
and
(iii) reporting to the Administrator a
plan for incorporating the standards developed under clause (ii) in all Administration programs and a plan to assure that
the data so collected are accessible to
health professionals, providers, researchers, and members of the public; and
(E) shall establish, maintain, and operate
a program to provide information on women’s substance abuse and mental health services.
(3) Study
(A) The Secretary, acting through the Assistant Secretary for Personnel, shall conduct
a study to evaluate the extent to which
women are represented among senior personnel at the Administration.
(B) Not later than 90 days after July 10, 1992,
the Assistant Secretary for Personnel shall
provide the Advisory Committee for Women’s
Services with a study plan, including the
methodology of the study and any sampling
frames. Not later than 180 days after July 10,
1992, the Assistant Secretary shall prepare and
submit directly to the Advisory Committee a
report concerning the results of the study conducted under subparagraph (A).
(C) The Secretary shall prepare and provide
to the Advisory Committee for Women’s Services any additional data as requested.
(4) Office
Nothing in this subsection shall be construed to preclude the Secretary from establishing within the Substance Abuse and Mental Health Administration an Office of Women’s Health.
(5) Definition
For purposes of this subsection, the term
‘‘women’s substance abuse and mental health
conditions’’, with respect to women of all age,
ethnic, and racial groups, means all aspects of
substance abuse and mental illness—
(A) unique to or more prevalent among
women; or
(B) with respect to which there have been
insufficient services involving women or insufficient data.
(g) Services of experts
(1) In general
The Administrator may obtain (in accordance with section 3109 of title 5, but without
regard to the limitation in such section on the
number of days or the period of service) the
services of not more than 20 experts or consultants who have professional qualifications.
Such experts and consultants shall be obtained for the Administration and for each of
its agencies.
(2) Compensation and expenses
(A) Experts and consultants whose services
are obtained under paragraph (1) shall be paid

Page 649

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or reimbursed for their expenses associated
with traveling to and from their assignment
location in accordance with sections 5724,
5724a(a), 5724a(c), and 5726(c) of title 5.
(B) Expenses specified in subparagraph (A)
may not be allowed in connection with the assignment of an expert or consultant whose
services are obtained under paragraph (1), unless and until the expert or consultant agrees
in writing to complete the entire period of assignment or one year, whichever is shorter,
unless separated or reassigned for reasons beyond the control of the expert or consultant
that are acceptable to the Secretary. If the expert or consultant violates the agreement, the
money spent by the United States for the expenses specified in subparagraph (A) is recoverable from the expert or consultant as a debt
of the United States. The Secretary may
waive in whole or in part a right of recovery
under this subparagraph.
(h) Peer review groups
The Administrator shall, without regard to
the provisions of title 5 governing appointments
in the competitive service, and without regard
to the provisions of chapter 51 and subchapter
III of chapter 53 of such title, relating to classification and General Schedule pay rates, establish such peer review groups and program advisory committees as are needed to carry out the
requirements of this subchapter and appoint and
pay members of such groups, except that officers
and employees of the United States shall not receive additional compensation for services as
members of such groups. The Federal Advisory
Committee Act shall not apply to the duration
of a peer review group appointed under this subsection.
(i) Voluntary services
The Administrator may accept voluntary and
uncompensated services.
(j) Administration
The Administrator shall ensure that programs
and activities assigned under this subchapter to
the Administration are fully administered by
the respective Centers to which such programs
and activities are assigned.
(k) Report concerning activities and progress
Not later than February 10, 1994, and once
every 2 years thereafter, the Administrator
shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives, and to the Committee on Labor
and Human Resources of the Senate, the report
containing—
(1) a description of the activities carried out
by the Administration;
(2) a description of any measurable progress
made in improving the availability and quality of substance abuse and mental health services;
(3) a description of the mechanisms by which
relevant research findings of the National Institute on Drug Abuse, the National Institute
on Alcohol Abuse and Alcoholism, and the National Institute of Mental Health have been
disseminated to service providers or otherwise
utilized by the Administration to further the
purposes of this subchapter; and

§ 290aa

(4) any report required in this subchapter to
be submitted to the Adminstrator 1 for inclusion in the report under this subsection.
(l) Applications for grants and contracts
With respect to awards of grants, cooperative
agreements, and contracts under this subchapter, the Administrator, or the Director of
the Center involved, as the case may be, may
not make such an award unless—
(1) an application for the award is submitted
to the official involved;
(2) with respect to carrying out the purpose
for which the award is to be provided, the application provides assurances of compliance
satisfactory to such official; and
(3) the application is otherwise in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the official determines to be necessary to
carry out the purpose for which the award is
to be provided.
(m) Emergency response
(1) In general
Notwithstanding section 290aa–3 of this title
and except as provided in paragraph (2), the
Secretary may use not to exceed 2.5 percent of
all amounts appropriated under this subchapter for a fiscal year to make noncompetitive grants, contracts or cooperative agreements to public entities to enable such entities to address emergency substance abuse or
mental health needs in local communities.
(2) Exceptions
Amounts appropriated under part C of this
subchapter shall not be subject to paragraph
(1).
(3) Emergencies
The Secretary shall establish criteria for determining that a substance abuse or mental
health emergency exists and publish such criteria in the Federal Register prior to providing funds under this subsection.
(n) Limitation on the use of certain information
No information, if an establishment or person
supplying the information or described in it is
identifiable, obtained in the course of activities
undertaken or supported under section 290aa–4
of this title may be used for any purpose other
than the purpose for which it was supplied unless such establishment or person has consented
(as determined under regulations of the Secretary) to its use for such other purpose. Such
information may not be published or released in
other form if the person who supplied the information or who is described in it is identifiable
unless such person has consented (as determined
under regulations of the Secretary) to its publication or release in other form.
(o) Authorization of appropriations
For the purpose of providing grants, cooperative agreements, and contracts under this section, there are authorized to be appropriated
$25,000,000 for fiscal year 2001, and such sums as
may be necessary for each of the fiscal years
2002 and 2003.
1 So

in original. Probably should be ‘‘Administrator’’.

§ 290aa

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title V, § 501, formerly Pub.
L. 93–282, title II, § 201, May 14, 1974, 88 Stat. 134,
as amended Pub. L. 94–371, § 8, July 26, 1976, 90
Stat. 1040; renumbered § 501 of act July 1, 1944,
and amended Pub. L. 98–24, § 2(b)(2), Apr. 26, 1983,
97 Stat. 176; Pub. L. 98–509, title II, § 201, title III,
§ 301(c)(1), Oct. 19, 1984, 98 Stat. 2359, 2364; Pub. L.
99–570, title IV, § 4003, Oct. 27, 1986, 100 Stat.
3207–106; Pub. L. 100–690, title II, § 2058(a)(2), Nov.
18, 1988, 102 Stat. 4213; Pub. L. 101–93, § 3(f), Aug.
16, 1989, 103 Stat. 611; Pub. L. 102–321, title I,
§ 101(a), July 10, 1992, 106 Stat. 324; Pub. L.
104–201, div. A, title XVII, § 1723(a)(3)(A), Sept. 23,
1996, 110 Stat. 2759; Pub. L. 106–129, § 2(b)(2), Dec.
6, 1999, 113 Stat. 1670; Pub. L. 106–310, div. B, title
XXXI, § 3102, title XXXIV, § 3401(a), Oct. 17, 2000,
114 Stat. 1170, 1218; Pub. L. 108–173, title IX,
§ 900(e)(2)(A), Dec. 8, 2003, 117 Stat. 2372; Pub. L.
111–148, title III, § 3509(d), Mar. 23, 2010, 124 Stat.
534.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (h), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5.
CODIFICATION
Section was formerly classified to section 3511 of this
title prior to renumbering by Pub. L. 98–24.
PRIOR PROVISIONS
A prior section 501 of act July 1, 1944, which was classified to section 219 of this title, was successively renumbered by subsequent acts and transferred, see section 238 of this title.
AMENDMENTS
2010—Subsec. (f)(1). Pub. L. 111–148, § 3509(d)(1), inserted ‘‘who shall report directly to the Administrator’’
before period at end.
Subsec. (f)(4), (5). Pub. L. 111–148, § 3509(d)(2), (3),
added par. (4) and redesignated former par. (4) as (5).
2003—Subsec. (d)(18). Pub. L. 108–173 substituted ‘‘Centers for Medicare & Medicaid Services’’ for ‘‘Health
Care Financing Administration’’.
2000—Subsec. (e)(1). Pub. L. 106–310, § 3401(a), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: ‘‘There
shall be in the Administration an Associate Administrator for Alcohol Prevention and Treatment Policy to
whom the Administrator shall delegate the functions of
promoting, monitoring, and evaluating service programs for the prevention and treatment of alcoholism
and alcohol abuse within the Center for Substance
Abuse Prevention, the Center for Substance Abuse
Treatment, and the Center for Mental Health Services,
and coordinating such programs among the Centers,
and among the Centers and other public and private entities. The Associate Administrator also shall ensure
that alcohol prevention, education, and policy strategies are integrated into all programs of the Centers
that address substance abuse prevention, education,
and policy, and that the Center for Substance Abuse
Prevention addresses the Healthy People 2000 goals and
the National Dietary Guidelines of the Department of
Health and Human Services and the Department of Agriculture related to alcohol consumption.’’
Subsecs. (m) to (o). Pub. L. 106–310, § 3102, added subsecs. (m) and (n), redesignated former subsec. (m) as (o),
and substituted ‘‘2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003’’ for
‘‘1993, and such sums as may be necessary for fiscal
year 1994’’ before period at end.
1999—Subsec. (d)(8), (9). Pub. L. 106–129, which directed the substitution of ‘‘Agency for Healthcare Research and Quality’’ for ‘‘Agency for Health Care Pol-

Page 650

icy and Research’’, was executed by making the substitution for ‘‘Agency for Health Care Policy Research’’,
to reflect the probable intent of Congress.
1996—Subsec. (g)(2)(A). Pub. L. 104–201 substituted
‘‘5724a(a), 5724a(c)’’ for ‘‘5724a(a)(1), 5724a(a)(3)’’.
1992—Pub. L. 102–321 amended section generally, substituting provisions relating to the Substance Abuse
and Mental Health Services Administration for provisions relating to the Alcohol, Drug Abuse, and Mental
Health Administration.
1989—Subsec. (b)(4). Pub. L. 101–93, § 3(f)(1), substituted ‘‘for’’ for ‘‘of’’.
Subsec. (j). Pub. L. 101–93, § 3(f)(2), substituted ‘‘section 290aa–5 of this title, establish program advisory
committees, and pay members of such groups and committees’’ for ‘‘section 290aa–5 of this title and appoint
and pay members of such groups’’ and ‘‘as members of
such groups or committees’’ for ‘‘as members of such
groups’’.
1988—Subsec. (b)(4). Pub. L. 100–690, § 2058(a)(2)(A),
added par. (4).
Subsec. (e)(2). Pub. L. 100–690, § 2058(a)(2)(B), substituted ‘‘Not less than once each three years, the Administrator’’ for ‘‘The Administrator’’ and ‘‘shall submit’’ for ‘‘shall annually submit’’.
Subsec. (f). Pub. L. 100–690, § 2058(a)(2)(C), substituted
‘‘misconduct’’ for ‘‘fraud’’ in heading and two places in
text.
Subsecs. (k) to (m). Pub. L. 100–690, § 2058(a)(2)(D), (E),
added subsecs. (k) to (m) and struck out former subsec.
(k), which related to Alcohol, Drug Abuse, and Mental
Health Advisory Board, including its duties, membership, terms of office, compensation, personnel, chairman, meetings, and reports to Congress.
1986—Pub. L. 99–570 amended section generally, revising and restating former subsecs. (a), (b), (c), (d), (e),
(f), (g), and (h) as (c), (d), (k), (h), (e), (f), (g), and (i),
respectively, and adding new subsecs. (a), (b), and (j).
1984—Pub. L. 98–509, § 301(c)(1), amended directory language of Pub. L. 98–24, § 2(b)(2). See 1983 Amendment
note below.
Subsec. (c). Pub. L. 98–509, § 201(a), substituted provisions relating to the Alcohol, Drug Abuse, and Mental
Health Advisory Board for provisions relating to the
National Panel on Alcohol, Drug Abuse, and Mental
Health.
Subsecs. (g), (h). Pub. L. 98–509, § 201(b), added subsecs. (g) and (h).
1983—Pub. L. 98–24, § 2(b)(2), as amended by Pub. L.
98–509, § 301(c)(1), renumbered section 3511 of this title
as this section.
Subsec. (a). Pub. L. 98–24, § 2(b)(2)(A), struck out ‘‘of
Health, Education, and Welfare’’ after ‘‘The Secretary’’
and ‘‘Department’’.
Subsec. (c). Pub. L. 98–24, § 2(b)(2)(A), (B), struck out
‘‘of Health, Education, and Welfare’’ after ‘‘The Secretary’’, and made a technical amendment to reference
to section 218 of this title to reflect the transfer of this
section to the Public Health Service Act.
Subsec. (d). Pub. L. 98–24, § 2(b)(2)(C), substituted provisions directing the Administrator to distribute information on the hazards of alcoholism and the abuse of
alcohol and drugs for provisions directing the Secretary, through the Administration, to evaluate and
make recommendations regarding improved, coordinated activities, where appropriate, for public education and other prevention programs with respect to
the abuse of alcohol and other substances.
Subsecs. (e), (f). Pub. L. 98–24, § 2(b)(2)(D), added subsecs. (e) and (f).
1976—Subsec. (d). Pub. L. 94–371 added subsec. (d).
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
Section 161 of Pub. L. 102–321 provided that: ‘‘Reference in any other Federal law, Executive order, rule,
regulation, or delegation of authority, or any document
of or pertaining to the Alcohol, Drug Abuse and Mental
Health Administration or to the Administrator of the
Alcohol, Drug Abuse and Mental Health Administration shall be deemed to refer to the Substance Abuse
and Mental Health Services Administration or to the
Administrator of the Substance Abuse and Mental
Health Services Administration.’’
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–201 effective 180 days after
Sept. 23, 1996, see section 1725(a) of Pub. L. 104–201, set
out as a note under section 5722 of Title 5, Government
Organization and Employees.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
TRANSFER PROVISIONS
Pub. L. 102–321, title I, subtitle D, July 10, 1992, 106
Stat. 370, as amended by Pub. L. 102–352, § 2(b)(1), Aug.
26, 1992, 106 Stat. 939, provided that:
‘‘SEC. 141. TRANSFERS.
‘‘(a) SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES
ADMINISTRATION.—Except as specifically provided
otherwise in this Act [see Tables for classification] or
an amendment made by this Act, there are transferred
to the Administrator of the Substance Abuse and Mental Health Services Administration all service related
functions which the Administrator of the Alcohol, Drug
Abuse and Mental Health Administration, or the Director of any entity within the Alcohol, Drug Abuse and
Mental Health Administration, exercised before the
date of the enactment of this Act [July 10, 1992] and all
related functions of any officer or employee of the Alcohol, Drug Abuse and Mental Health Administration.
‘‘(b) NATIONAL INSTITUTES.—Except as specifically
provided otherwise in this Act or an amendment made
by this Act, there are transferred to the appropriate Directors of the National Institute on Alcohol Abuse and
Alcoholism, the National Institute on Drug Abuse and
the National Institute of Mental Health, through the
Director of the National Institutes of Health, all research related functions which the Administrator of
the Alcohol, Drug Abuse and Mental Health Administration exercised before the date of the enactment of
this Act and all related functions of any officer or employee of the Alcohol, Drug Abuse, and Mental Health
Administration.
‘‘(c) ADEQUATE PERSONNEL AND RESOURCES.—The
transfers required under this subtitle shall be effectuated in a manner that ensures that the Substance
Abuse and Mental Health Services Administration has
adequate personnel and resources to carry out its statutory responsibilities and that the National Institute
on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of Mental Health have adequate personnel and resources to
enable such institutes to carry out their respective
statutory responsibilities.

§ 290aa

‘‘SEC. 142. TRANSFER AND ALLOCATIONS OF APPROPRIATIONS AND PERSONNEL.
‘‘(a) SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES
ADMINISTRATION.—Except as otherwise provided in the
Public Health Service Act [this chapter], all personnel
employed in connection with, and all assets, liabilities,
contracts, property, records, and unexpended balances
of appropriations, authorizations, allocations, and
other funds employed, used, held, arising from, available to, or to be made available in connection with the
functions transferred to the Administrator of the Substance Abuse and Mental Health Services Administration by this subtitle, subject to section 1531 of title 31,
United States Code, shall be transferred to the Substance Abuse and Mental Health Services Administration. Unexpended funds transferred pursuant to this
subsection shall be used only for the purposes for which
the funds were originally authorized and appropriated.
‘‘(b) NATIONAL INSTITUTES.—Except as otherwise provided in the Public Health Service Act, all personnel
employed in connection with, and all assets, liabilities,
contracts, property, records, and unexpended balances
of appropriations, authorizations, allocations, and
other funds employed, used, held, arising from, available to, or to be made available in connection with the
functions transferred to the Directors of the National
Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of Mental Health by this subtitle, subject to section 1531 of title 31, United States Code, shall be transferred to the National Institute on Alcohol Abuse and
Alcoholism, the National Institute on Drug Abuse and
the National Institute of Mental Health. Unexpended
funds transferred pursuant to this subsection shall be
used only for the purposes for which the funds were
originally authorized and appropriated.
‘‘(c) CUSTODY OF BALANCES.—The actual transfer of
custody of obligation balances is not required in order
to implement this section.
‘‘SEC. 143. INCIDENTAL TRANSFERS.
‘‘Prior to October 1, 1992, the Secretary of Health and
Human Services is authorized to make such determinations as may be necessary with regard to the functions
transferred by this subtitle, and to make such additional incidental dispositions of personnel, assets, liabilities, grants, contracts, property, records, and unexpended balances of appropriations, authorizations,
allocations, and other funds held, used, arising from,
available to, or to be made available in connection with
such functions, as may be necessary to carry out the
provisions of this subtitle and the Public Health Service Act [this chapter]. Such Secretary shall provide for
the termination of the affairs of all entities terminated
by this subtitle and for such further measures and dispositions as may be necessary to effectuate the purposes of this subtitle.
‘‘SEC. 144. EFFECT ON PERSONNEL.
‘‘(a) IN GENERAL.—Except as otherwise provided by
this subtitle and the Public Health Service Act [this
chapter], the transfer pursuant to this subtitle of fulltime personnel (except special Government employees)
and part-time personnel holding permanent positions
shall not cause any such employee to be separated or
reduced in grade or compensation for one year after the
date of transfer of such employee under this subtitle.
‘‘(b) EXECUTIVE SCHEDULE POSITIONS.—Any person
who, on the day preceding the effective date of this Act
[see Effective Date of 1992 Amendment note set out
under section 236 of this title], held a position compensated in accordance with the Executive Schedule
prescribed in chapter 53 of title 5, United States Code,
and who, without a break in service, is appointed in the
Substance Abuse and Mental Health Services Administration to a position having duties comparable to the
duties performed immediately preceding such appointment shall continue to be compensated in such new position at not less than the rate provided for such previous position, for the duration of the service of such
person in such new position.

§ 290aa

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘SEC. 145. SAVINGS PROVISIONS.
‘‘(a) EFFECT ON PREVIOUS DETERMINATIONS.—All orders, determinations, rules, regulations, permits, contracts, certificates, licenses, and privileges that—
‘‘(1) have been issued, made, granted, or allowed to
become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions which are
transferred by this subtitle; and
‘‘(2) are in effect on the date of enactment of this
Act [July 10, 1992];
shall continue in effect according to their terms until
modified, terminated, superseded, set aside, or revoked
in accordance with law by the President, the Director
of the National Institutes of Health, or the Administrator of the Substance Abuse and Mental Health Services Administration, as appropriate, a court of competent jurisdiction, or by operation of law.
‘‘(b) CONTINUATION OF PROCEEDINGS.—
‘‘(1) IN GENERAL.—The provisions of this subtitle
shall not affect any proceedings, including notices of
proposed rule making, or any application for any license, permit, certificate, or financial assistance
pending on the date of enactment of this Act before
the Department of Health and Human Services, which
relates to the Alcohol, Drug Abuse and Mental Health
Administration or the National Institute on Alcohol
Abuse and Alcoholism, the National Institute on
Drug Abuse, or the National Institute of Mental
Health, or any office thereof with respect to functions transferred by this subtitle. Such proceedings
or applications, to the extent that they relate to
functions transferred, shall be continued. Orders shall
be issued in such proceedings, appeals shall be taken
therefrom, and payments shall be made under such
orders, as if this Act [see Tables for classification]
had not been enacted, and orders issued in any such
proceedings shall continue in effect until modified,
terminated, superseded, or revoked by the Administrator of the Substance Abuse and Mental Health
Services Administration or the Directors of the National Institute on Alcohol Abuse and Alcoholism,
the National Institute on Drug Abuse and the National Institute of Mental Health by a court of competent jurisdiction, or by operation of law. Nothing
in this subsection prohibits the discontinuance or
modification of any such proceeding under the same
terms and conditions and to the same extent that
such proceeding could have been discontinued or
modified if this subtitle had not been enacted.
‘‘(2) REGULATIONS.—The Secretary of Health and
Human Services is authorized to issue regulations
providing for the orderly transfer of proceedings continued under paragraph (1).
‘‘(c) EFFECT ON LEGAL ACTIONS.—Except as provided
in subsection (e)—
‘‘(1) the provisions of this subtitle do not affect actions commenced prior to the date of enactment of
this Act [July 10, 1992]; and
‘‘(2) in all such actions, proceedings shall be had,
appeals taken, and judgments rendered in the same
manner and effect as if this Act had not been enacted.
‘‘(d) NO ABATEMENT OF ACTIONS OR PROCEEDINGS.—No
action or other proceeding commenced by or against
any officer in his official capacity as an officer of the
Department of Health and Human Services with respect
to functions transferred by this subtitle shall abate by
reason of the enactment of this Act [see Tables for classification]. No cause of action by or against the Department of Health and Human Services with respect to
functions transferred by this subtitle, or by or against
any officer thereof in his official capacity, shall abate
by reason of the enactment of this Act. Causes of action and actions with respect to a function transferred
by this subtitle, or other proceedings may be asserted
by or against the United States or the Administrator of
the Alcohol, Drug Abuse and Mental Health Administration or the Directors of the National Institute on
Alcohol Abuse and Alcoholism, the National Institute
on Drug Abuse, and the National Institute of Mental

Page 652

Health, as may be appropriate, and, in an action pending when this Act takes effect [see Effective Date of
1992 Amendment note set out under section 236 of this
title], the court may at any time, on its own motion or
that of any party, enter an order which will give effect
to the provisions of this subsection.
‘‘(e) SUBSTITUTION.—If, before the date of enactment
of this Act [July 10, 1992], the Department of Health
and Human Services, or any officer thereof in the official capacity of such officer, is a party to an action,
and under this subtitle any function of such Department, Office, or officer is transferred to the Administrator of the Substance Abuse and Mental Health Services Administration or the Directors of the National Institute on Alcohol Abuse and Alcoholism, the National
Institute on Drug Abuse and the National Institute of
Mental Health, then such action shall be continued
with the Administrator of the Substance Abuse and
Mental Health Services Administration or the Directors of the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the
National Institute of Mental Health, as the case may
be, substituted or added as a party.
‘‘(f) JUDICIAL REVIEW.—Orders and actions of the Administrator of the Substance Abuse and Mental Health
Services Administration or the Directors of the National Institute on Alcohol Abuse and Alcoholism, the
National Institute on Drug Abuse and the National Institute of Mental Health in the exercise of functions
transferred to the Directors by this subtitle shall be
subject to judicial review to the same extent and in the
same manner as if such orders and actions had been by
the Administrator of the Alcohol, Drug Abuse and Mental Health Administration or the Directors of the National Institute on Alcohol Abuse and Alcoholism, the
National Institute on Drug Abuse, and the National Institute of Mental Health, or any office or officer thereof, in the exercise of such functions immediately preceding their transfer. Any statutory requirements relating to notice, hearings, action upon the record, or
administrative review that apply to any function transferred by this subtitle shall apply to the exercise of
such function by the Administrator of the Substance
Abuse and Mental Health Services Administration or
the Directors.
‘‘SEC. 146. TRANSITION.
‘‘With the consent of the Secretary of Health and
Human Services, the Administrator of the Substance
Abuse and Mental Health Services Administration and
the Directors of the National Institute on Alcohol
Abuse and Alcoholism, the National Institute on Drug
Abuse and the National Institute of Mental Health are
authorized to utilize—
‘‘(1) the services of such officers, employees, and
other personnel of the Department with respect to
functions transferred to the Administrator of the
Substance Abuse and Mental Health Services Administration and the Director of the National Institute
on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of
Mental Health by this subtitle; and
‘‘(2) funds appropriated to such functions for such
period of time as may reasonably be needed to facilitate the orderly implementation of this subtitle.
‘‘SEC. 147. PEER REVIEW.
‘‘With respect to fiscal years 1993 through 1996, the
peer review systems, advisory councils and scientific
advisory committees utilized, or approved for utilization, by the National Institute on Alcohol Abuse and
Alcoholism, the National Institute on Drug Abuse and
the National Institute of Mental Health prior to the
transfer of such Institutes to the National Institute of
Health shall be utilized by such Institutes.
‘‘SEC. 148. MERGERS.
‘‘Notwithstanding the provisions of section 401(c)(2)
of the Public Health Service Act (42 U.S.C. 281(c)(2)),
the Secretary of Health and Human Services may not
merge the National Institute on Alcohol Abuse and Al-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

coholism, the National Institute on Drug Abuse or the
National Institute of Mental Health with any other institute or entity (or with each other) within the national research institutes for a 5-year period beginning
on the date of enactment of this Act [July 10, 1992].
‘‘SEC. 149. CONDUCT OF MULTI-YEAR RESEARCH
PROJECTS.
‘‘With respect to multi-year grants awarded prior to
fiscal year 1993 by the National Institute on Alcohol
Abuse and Alcoholism, the National Institute on Drug
Abuse, and the National Institute of Mental Health
with amounts received under section 1911(b) [former
section 300x(b) of this title], as such section existed one
day prior to the date of enactment of this Act [July 10,
1992], such grants shall be continued for the entire period of the grant through the utilization of funds made
available pursuant to sections 464H, 464L, and 464R [sections 285n, 285o, 285p of this title], as appropriate, subject to satisfactory performance.
‘‘SEC. 150. SEPARABILITY.
‘‘If a provision of this subtitle or its application to
any person or circumstance is held invalid, neither the
remainder of this Act [see Tables for classification] nor
the application of the provision to other persons or circumstances shall be affected.
‘‘SEC. 151. BUDGETARY AUTHORITY.
‘‘With respect to fiscal years 1994 and 1995, the Directors of the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and
the National Institute of Mental Health shall notwithstanding section 405(a) [section 284(a) of this title], prepare and submit, directly to the President for review
and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of
personnel needs for the Institute) for their respective
Institutes, after reasonable opportunity for comment
(but without change) by the Secretary of Health and
Human Services, the Director of the National Institutes of Health, and the Institute’s advisory council.’’
REPORT BY SUBSTANCE ABUSE AND MENTAL HEALTH
SERVICES ADMINISTRATION
Section 708 of Pub. L. 102–321 directed Administrator
of Substance Abuse and Mental Health Services Administration to submit to Congress an interim report, not
later than 6 months after July 10, 1992, and a final report, not later than Oct. 1, 1993, concerning current
policies and barriers to provision of substance abuse
and mental health services, with emphasis on barriers
to health insurance and Medicaid coverage of such
services, and further directed Secretary of Health and
Human Services to initiate, not later than Jan. 1, 1994,
research and demonstration projects which, consistent
with information from reports submitted by the Administrator, explore alternative mechanisms of providing health insurance and treatment services for substance abuse and mental illness.
RELATIONSHIP BETWEEN MENTAL ILLNESS AND
SUBSTANCE ABUSE
Section 2071 of Pub. L. 100–690 directed Secretary of
Health and Human Services to conduct a study for the
purpose of determining the relationship between mental illness and substance abuse, and developing recommendations on the most effective methods of treatment
for individuals with both mental illness and substance
abuse problems, and, not later than 12 months after
Nov. 18, 1988, to complete the study and submit to Congress the findings made as a result of the study.

§ 290aa–1

not later than 12 months after the date on which any
contract requested is entered into, provide for the completion of the review and submit to Congress a report
describing the findings made as a result of the review,
with Secretary of Health and Human Services authorized to enter into a contract with National Academy of
Sciences to carry out the review.
CONGRESSIONAL STATEMENT OF POLICY FOR ALCOHOL
AND DRUG ABUSE AMENDMENTS OF 1983
Section 1(b) of Pub. L. 98–24 provided that: ‘‘It is the
policy of the United States and the purpose of this Act
[see Short Title of 1983 Amendment note set out under
section 201 of this title] to provide leadership in the national effort to reduce the incidence of alcoholism and
alcohol-related problems and drug abuse through—
‘‘(1) a continued Federal commitment to research
into the behavioral and biomedical etiology, the
treatment, and the mental and physical health and
social and economic consequences of alcohol abuse
and alcoholism and drug abuse;
‘‘(2) a commitment to—
‘‘(A) extensive dissemination to States, units of
local government, community organizations, and
private groups of the most recent information and
research findings with respect to alcohol abuse and
alcoholism and drug abuse, including information
with respect to the application of research findings;
and
‘‘(B) the accomplishment of such dissemination
through up-to-date publications, demonstrations,
educational programs, and other appropriate
means;
‘‘(3) the provision of technical assistance to research personnel; services personnel, and prevention
personnel in the field of alcohol abuse and alcoholism
and drug abuse;
‘‘(4) the development and encouragement of prevention programs designed to combat the spread of alcoholism, alcohol abuse, drug abuse, and the abuse of
other legal and illegal substances;
‘‘(5) the development and encouragement of effective occupational prevention and treatment programs
within Government and in cooperation with the private sector; and
‘‘(6) the provision of a Federal response to alcohol
abuse and alcoholism and drug abuse which encourages the greatest participation by the private sector,
both financially and otherwise, and concentrates on
carrying out functions relating to alcohol abuse and
alcoholism and drug abuse which are truly national
in scope.’’
ALCOHOL AND DRUG ABUSE AND MENTAL HEALTH
REPORTS BY THE SECRETARY
Section 3 of Pub. L. 98–24 directed Secretary of
Health and Human Services to submit to Congress, on
or before Jan. 15, 1984, a report describing the extent to
which Federal and State programs, departments, and
agencies are concerned and are dealing effectively with
problems of alcohol abuse and alcoholism, problems of
drug abuse, and mental illness.
TRANSFER OF BALANCES IN WORKING CAPITAL FUND,
NARCOTIC HOSPITALS, TO SURPLUS FUND
Act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, provided: ‘‘That as of June 30, 1947, and the end of each fiscal year thereafter any balances in the ‘Working capital fund, narcotic hospitals,’ in excess of $150,000 shall
be transferred to the surplus fund of the Treasury.’’
[Section 201 of act July 8, 1947, set out above, was formerly classified to section 258a of this title.]

REPORT WITH RESPECT TO ADMINISTRATION OF CERTAIN
RESEARCH PROGRAMS

§ 290aa–1. Advisory councils

Section 2073 of Pub. L. 100–690 directed Secretary of
Health and Human Services to request National Academy of Sciences to conduct a review of research activities of National Institutes of Health and the Alcohol,
Drug Abuse, and Mental Health Administration and,

(a) Appointment
(1) In general
The Secretary shall appoint an advisory
council for—

§ 290aa–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the Substance Abuse and Mental
Health Services Administration;
(B) the Center for Substance Abuse Treatment;
(C) the Center for Substance Abuse Prevention; and
(D) the Center for Mental Health Services.
Each such advisory council shall advise, consult with, and make recommendations to the
Secretary and the Administrator or Director
of the Administration or Center for which the
advisory council is established concerning
matters relating to the activities carried out
by and through the Administration or Center
and the policies respecting such activities.
(2) Function and activities
An advisory council—
(A)(i) may on the basis of the materials
provided by the organization respecting activities conducted at the organization, make
recommendations to the Administrator or
Director of the Administration or Center for
which it was established respecting such activities;
(ii) shall review applications submitted for
grants and cooperative agreements for activities for which advisory council approval
is required under section 290aa–3(d)(2) of this
title and recommend for approval applications for projects that show promise of making valuable contributions to the Administration’s mission; and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or
entered into by the organization;
(B) may collect, by correspondence or by
personal investigation, information as to
studies and services that are being carried
on in the United States or any other country
as to the diseases, disorders, or other aspects
of human health with respect to which the
organization was established and with the
approval of the Administrator or Director,
whichever is appropriate, make such information available through appropriate publications for the benefit of public and private
health entities and health professions personnel and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership
(1) In general
Each advisory council shall consist of nonvoting ex officio members and not more than
12 members to be appointed by the Secretary
under paragraph (3).
(2) Ex officio members
The ex officio members of an advisory council shall consist of—
(A) the Secretary;
(B) the Administrator;
(C) the Director of the Center for which
the council is established;
(D) the Under Secretary for Health of the
Department of Veterans Affairs;
(E) the Assistant Secretary for Defense for
Health Affairs (or the designates of such officers); and

Page 654

(F) such additional officers or employees
of the United States as the Secretary determines necessary for the advisory council to
effectively carry out its functions.
(3) Appointed members
Individuals shall be appointed to an advisory
council under paragraph (1) as follows:
(A) Nine of the members shall be appointed
by the Secretary from among the leading
representatives of the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
the Administration or Center for which the
advisory council is established.
(B) Three of the members shall be appointed by the Secretary from the general
public and shall include leaders in fields of
public policy, public relations, law, health
policy economics, or management.
(4) Compensation
Members of an advisory council who are officers or employees of the United States shall
not receive any compensation for service on
the advisory council. The remaining members
of an advisory council shall receive, for each
day (including travel time) they are engaged
in the performance of the functions of the advisory council, compensation at rates not to
exceed the daily equivalent to the annual rate
in effect for grade GS–18 of the General Schedule.
(c) Terms of office
(1) In general
The term of office of a member of an advisory council appointed under subsection (b) of
this section shall be 4 years, except that any
member appointed to fill a vacancy for an unexpired term shall serve for the remainder of
such term. The Secretary shall make appointments to an advisory council in such a manner
as to ensure that the terms of the members
not all expire in the same year. A member of
an advisory council may serve after the expiration of such member’s term until a successor has been appointed and taken office.
(2) Reappointments
A member who has been appointed to an advisory council for a term of 4 years may not be
reappointed to an advisory council during the
2-year period beginning on the date on which
such 4-year term expired.
(3) Time for appointment
If a vacancy occurs in an advisory council
among the members under subsection (b) of
this section, the Secretary shall make an appointment to fill such vacancy within 90 days
from the date the vacancy occurs.
(d) Chair
The Secretary shall select a member of an advisory council to serve as the chair of the council. The Secretary may so select an individual
from among the appointed members, or may select the Administrator or the Director of the
Center involved. The term of office of the chair
shall be 2 years.
(e) Meetings
An advisory council shall meet at the call of
the chairperson or upon the request of the Ad-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

ministrator or Director of the Administration or
Center for which the advisory council is established, but in no event less than 2 times during
each fiscal year. The location of the meetings of
each advisory council shall be subject to the approval of the Administrator or Director of Administration or Center for which the council
was established.
(f) Executive Secretary and staff
The Administrator or Director of the Administration or Center for which the advisory council
is established shall designate a member of the
staff of the Administration or Center for which
the advisory council is established to serve as
the Executive Secretary of the advisory council.
The Administrator or Director shall make available to the advisory council such staff, information, and other assistance as it may require to
carry out its functions. The Administrator or
Director shall provide orientation and training
for new members of the advisory council to provide for their effective participation in the functions of the advisory council.
(July 1, 1944, ch. 373, title V, § 502, formerly § 505,
as added Pub. L. 99–570, title IV, § 4004(a), Oct. 27,
1986, 100 Stat. 3207–109; amended Pub. L. 100–527,
§ 10(4), Oct. 25, 1988, 102 Stat. 2641; Pub. L.
101–381, title I, § 102(6), Aug. 18, 1990, 104 Stat. 586;
renumbered § 502 and amended Pub. L. 102–321,
title I, § 102, July 10, 1992, 106 Stat. 331; Pub. L.
102–352, § 2(a)(6), Aug. 26, 1992, 106 Stat. 938; Pub.
L. 103–446, title XII, § 1203(a)(1), Nov. 2, 1994, 108
Stat. 4689; Pub. L. 106–310, div. B, title XXXIV,
§ 3402, Oct. 17, 2000, 114 Stat. 1219.)
CODIFICATION
Section was formerly classified to section 290aa–3a of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 290aa–1, act July 1, 1944, ch. 373, title
V, § 502, formerly Pub. L. 91–616, title I, § 101, Dec. 31,
1970, 84 Stat. 1848, as amended Pub. L. 93–282, title II,
§ 203(a), May 14, 1974, 88 Stat. 135; Pub. L. 96–180, § 3, Jan.
2, 1980, 93 Stat. 1302; Pub. L. 97–35, title IX, § 966(a), Aug.
13, 1981, 95 Stat. 595; renumbered § 502 of act July 1, 1944,
and amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(3), 97
Stat. 177; Oct. 19, 1984, Pub. L. 98–509, title II, § 205(b)(2),
98 Stat. 2361; Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4005(b)(1), 100 Stat. 3207–114, related to National Institute on Alcohol Abuse and Alcoholism, prior to repeal
by Pub. L. 102–321, title I, § 101(b), July 10, 1992, 106 Stat.
331. See section 285n of this title.
A prior section 502 of act July 1, 1944, which was classified to section 220 of this title, was successively renumbered by subsequent acts and transferred, see section 238a of this title.
AMENDMENTS
2000—Subsec. (e). Pub. L. 106–310 substituted ‘‘2 times
during each fiscal year’’ for ‘‘3 times during each fiscal
year’’.
1994—Subsec. (b)(2)(D). Pub. L. 103–446 amended subpar. (D) generally. Prior to amendment, subpar. (D)
read as follows: ‘‘the Chief Medical Director of the Veterans Administration; and’’.
1992—Pub. L. 102–352 substituted ‘‘or management’’
for ‘‘and management’’ in subsec. (b)(3)(B).
Pub. L. 102–321 amended section generally, substituting provisions relating to appointment of advisory
councils to Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, Center for Substance Abuse Prevention, and Center for Mental Health Services for provisions appoint-

§ 290aa–1

ing advisory councils for National Institute on Alcohol
Abuse and Alcoholism, National Institute on Drug
Abuse, and National Institute of Mental Health.
1990—Subsec. (a)(2). Pub. L. 101–381 made technical
amendment to reference to section 300aaa of this title
to reflect renumbering of corresponding section of
original act.
1988—Subsec. (b)(2)(A). Pub. L. 100–527 substituted
‘‘Chief Medical Director of the Department of Veterans
Affairs’’ for ‘‘Chief Medical Director of the Veterans’
Administration’’.
EFFECTIVE DATE OF 1992 AMENDMENTS
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–527 effective Mar. 15, 1989,
see section 18(a) of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 301 of
Title 38, Veterans’ Benefits.
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
CONTINUATION OF EXISTING ADVISORY COUNCILS
Section 4004(b) of Pub. L. 99–570 provided that: ‘‘The
amendment made by subsection (a) [enacting this section and renumbering this section and section 290aa–5
of this title] does not terminate the membership of any
advisory council for the National Institute on Alcohol
Abuse and Alcoholism, the National Institute on Drug
Abuse, or the National Institute of Mental Health
which was in existence on the date of enactment of this
Act [Oct. 27, 1986]. After such date—
‘‘(1) the Secretary of Health and Human Services
shall make appointments to each such advisory council in such a manner as to bring about as soon as
practicable the composition for such council prescribed by section 505 [now 502] of the Public Health
Service Act [this section];
‘‘(2) each advisory council shall organize itself in
accordance with such section and exercise the functions prescribed by such section; and
‘‘(3) the Director of each such institute shall perform for such advisory council the functions prescribed by such section.’’

§ 290aa–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 290aa–2. Omitted
CODIFICATION
Section, act July 1, 1944, ch. 373, title V, § 503, formerly § 505, as added Pub. L. 98–24, § 2(b)(7), Apr. 26, 1983,
97 Stat. 178; renumbered § 506, Pub. L. 99–570, title IV,
§ 4004(a), Oct. 27, 1986, 100 Stat. 3207–109; renumbered
§ 503, Pub. L. 102–321, title I, § 103, July 10, 1992, 106 Stat.
333, which required the Secretary of Health and Human
Services to submit triennial reports to Congress on the
health consequences of using alcoholic beverages, the
health consequences and extent of drug abuse in the
United States, and current research findings made with
respect to drug abuse, including current findings on the
health effects of marihuana and the addictive property
of tobacco, terminated, effective May 15, 2000, pursuant
to section 3003 of Pub. L. 104–66, as amended, set out as
a note under section 1113 of Title 31, Money and Finance. See, also, pages 92 and 93 of House Document No.
103–7.
Section was formerly classified to section 290aa–4 of
this title prior to renumbering by Pub. L. 102–321.
A prior section 290aa–2, act July 1, 1944, ch. 373, title
V, § 503, formerly Pub. L. 92–255, title IV, § 406(a), title
V, § 501, Mar. 21, 1972, 86 Stat. 78, 85; amended Pub. L.
93–282, title II, § 204, May 14, 1974, 88 Stat. 136; Pub. L.
94–237, § 12(a), Mar. 19, 1976, 90 Stat. 247; Pub. L. 96–181,
§ 10, Jan. 2, 1980, 93 Stat. 1314; Pub. L. 97–35, title IX,
§§ 968(a), 973(f), Aug. 13, 1981, 95 Stat. 595, 598; renumbered § 503 of act July 1, 1944, and amended Apr. 26, 1983,
Pub. L. 98–24, § 2(b)(4), (5), 97 Stat. 177; Oct. 19, 1984, Pub.
L. 98–509, title II, §§ 202, 205(b)(1), 98 Stat. 2360, 2361; Oct.
27, 1986, Pub. L. 99–570, title IV, § 4005(b)(2), 100 Stat.
3207–114, related to National Institute on Drug Abuse,
prior to repeal by Pub. L. 102–321, title I, § 101(b), July
10, 1992, 106 Stat. 331. See section 285o of this title.
A prior section 503 of act July 1, 1944, which was classified to section 221 of this title, was successively renumbered by subsequent acts and transferred, see section 238b of this title.

§ 290aa–2a. Report on individuals with co-occurring mental illness and substance abuse disorders
(a) In general
Not later than 2 years after October 17, 2000,
the Secretary shall, after consultation with organizations representing States, mental health
and substance abuse treatment providers, prevention specialists, individuals receiving treatment services, and family members of such individuals, prepare and submit to the Committee
on Health, Education, Labor, and Pensions of
the Senate and the Committee on Commerce of
the House of Representatives, a report on prevention and treatment services for individuals
who have co-occurring mental illness and substance abuse disorders.
(b) Report content
The report under subsection (a) of this section
shall be based on data collected from existing
Federal and State surveys regarding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
(1) a summary of the manner in which individuals with co-occurring disorders are receiving treatment, including the most up-to-date
information available regarding the number of
children and adults with co-occurring mental
illness and substance abuse disorders and the
manner in which funds provided under sections 300x and 300x–21 of this title are being
utilized, including the number of such children
and adults served with such funds;

Page 656

(2) a summary of improvements necessary to
ensure that individuals with co-occurring
mental illness and substance abuse disorders
receive the services they need;
(3) a summary of practices for preventing
substance abuse among individuals who have a
mental illness and are at risk of having or acquiring a substance abuse disorder; and
(4) a summary of evidenced-based practices
for treating individuals with co-occurring
mental illness and substance abuse disorders
and recommendations for implementing such
practices.
(c) Funds for report
The Secretary may obligate funds to carry out
this section with such appropriations as are
available.
(July 1, 1944, ch. 373, title V, § 503A, as added
Pub. L. 106–310, div. B, title XXXIV, § 3406, Oct.
17, 2000, 114 Stat. 1221.)
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 290aa–3. Peer review
(a) In general
The Secretary, after consultation with the Administrator, shall require appropriate peer review of grants, cooperative agreements, and contracts to be administered through the agency
which exceed the simple acquisition threshold as
defined in section 134 of title 41.
(b) Members
The members of any peer review group established under subsection (a) of this section shall
be individuals who by virtue of their training or
experience are eminently qualified to perform
the review functions of the group. Not more
than one-fourth of the members of any such peer
review group shall be officers or employees of
the United States.
(c) Advisory council review
If the direct cost of a grant or cooperative
agreement (described in subsection (a) of this
section) exceeds the simple acquisition threshold as defined by section 134 of title 41, the Secretary may make such a grant or cooperative
agreement only if such grant or cooperative
agreement is recommended—
(1) after peer review required under subsection (a) of this section; and
(2) by the appropriate advisory council.
(d) Conditions
The Secretary may establish limited exceptions to the limitations contained in this section regarding participation of Federal employees and advisory council approval. The circumstances under which the Secretary may make
such an exception shall be made public.
(July 1, 1944, ch. 373, title V, § 504, formerly § 506,
as added Pub. L. 98–24, § 2(b)(7), Apr. 26, 1983, 97
Stat. 178; amended Pub. L. 99–158, § 3(c), Nov. 20,

Page 657

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1985, 99 Stat. 879; renumbered § 507 and amended
Pub. L. 99–570, title IV, §§ 4004(a), 4007, Oct. 27,
1986, 100 Stat. 3207–109, 3207–115; renumbered § 504
and amended Pub. L. 102–321, title I, § 104, July
10, 1992, 106 Stat. 333; Pub. L. 102–352, § 2(a)(7),
Aug. 26, 1992, 106 Stat. 938; Pub. L. 105–392, title
IV, § 412, Nov. 13, 1998, 112 Stat. 3590; Pub. L.
106–310, div. B, title XXXIV, § 3401(b), Oct. 17,
2000, 114 Stat. 1218.)
CODIFICATION
In subsecs. (a) and (c), ‘‘section 134 of title 41’’ substituted for ‘‘section 4(11) of the Office of Federal Procurement Policy Act’’ on authority of Pub. L. 111–350,
§ 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted
Title 41, Public Contracts.
Section was formerly classified to section 290aa–5 of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 290aa–3, act July 1, 1944, ch. 373, title
V, § 504, formerly title IV, § 455, as added May 14, 1974,
Pub. L. 93–282, title II, § 202, 88 Stat. 135; amended Oct.
7, 1980, Pub. L. 96–398, title III, § 325, title IV, § 401(a),
title VIII, § 804(a), 94 Stat. 1596, 1597, 1608; Aug. 13, 1981,
Pub. L. 97–35, title IX, § 902(g)(1), 95 Stat. 560; renumbered title V, § 504, Apr. 26, 1983, Pub. L. 98–24, § 2(b)(6),
97 Stat. 177; Oct. 19, 1984, Pub. L. 98–509, title II, §§ 203,
204, 98 Stat. 2360, 2361; Oct. 7, 1985, Pub. L. 99–117, § 11(b),
99 Stat. 495; Oct. 27, 1986, Pub. L. 99–570, title IV,
§§ 4011(a), 4012, 4013, 4021(a), (b)(1), 100 Stat. 3207–115,
3207–116, 3207–124; Nov. 14, 1986, Pub. L. 99–660, title V,
§ 504, 100 Stat. 3797; Nov. 18, 1988, Pub. L. 100–690, title
II, § 2057(1), (2), 102 Stat. 4211, related to National Institute of Mental Health, prior to repeal by Pub. L.
102–321, title I, § 101(b), July 10, 1992, 106 Stat. 331. See
section 285p of this title.
A prior section 504 of act July 1, 1944, which was classified to section 222 of this title, was renumbered section 2104 of act July 1, 1944, by Pub. L. 98–24 and transferred to section 300aa–3 of this title, renumbered section 2304 of act July 1, 1944, by Pub. L. 99–660 and transferred to section 300cc–3 of this title, prior to repeal by
Pub. L. 98–621, § 10(s), Nov. 8, 1984, 98 Stat. 3381.
AMENDMENTS
2000—Pub. L. 106–310 reenacted section catchline
without change and amended text generally, substituting, in subsec. (a), provisions requiring, after consultation with the Administrator of the Substance Abuse
and Mental Health Services Administration, appropriate peer review of grants, cooperative agreements,
and contracts to be administered through the agency
that exceed the simple acquisition threshold as defined
in section 403 of title 41 for provisions requiring such
peer review after consultation with the Directors of the
Center for Substance Abuse Treatment, the Center for
Substance Abuse Prevention, and the Center for Mental
Health Services, in subsec. (b), provisions relating to
members of peer groups qualified to perform review
functions under subsec. (a) for similar provisions in
former subsec. (b) but which included reference to regulatory establishment of such groups, in subsec. (c), provisions relating to advisory council review for provisions relating to requirements and specification of regulations promulgated under subsec. (a), and in subsec.
(d), provisions relating to Secretary’s authority to establish exceptions to the limitations in section regarding participation of Federal employees and advisory
council approval for provisions relating to recommendations.
1998—Subsec. (d)(2). Pub. L. 105–392 substituted ‘‘or
cooperative agreement’’ for ‘‘cooperative agreement, or
contract’’ wherever appearing in introductory provisions.
1992—Pub. L. 102–352 struck out ‘‘by regulation’’ after
‘‘Center for Mental Health Services, shall’’ in subsec.
(a).

§ 290aa–4

Pub. L. 102–321 amended section generally, substituting provisions relating to peer review of grants, cooperative agreements, and contracts administered through
the Centers for Substance Abuse Treatment, Substance
Abuse Prevention, and Mental Health Services for provisions relating to peer review of biomedical and behavioral research and development grants, cooperative
agreements, and contracts administered through the
National Institutes of Mental Health, Alcohol Abuse
and Alcoholism, and Drug Abuse.
1986—Subsec. (b). Pub. L. 99–570, § 4007, inserted ‘‘applications made for’’ before ‘‘grants, cooperative’’ in introductory text.
1985—Subsec. (e). Pub. L. 99–158 added subsec. (e).
EFFECTIVE DATE OF 1992 AMENDMENTS
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290aa–3a. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title V, § 505, as
added Oct. 27, 1986, Pub. L. 99–570, title IV, § 4004(a), 100
Stat. 3207–109, and amended, which related to advisory
councils for the National Institute on Alcohol Abuse
and Alcoholism, the National Institute on Drug Abuse,
and the National Institute of Mental Health, was renumbered section 502 of act July 1, 1944, by Pub. L.
102–321, title I, § 102(1), July 10, 1992, 106 Stat. 331, and
transferred to section 290aa–1 of this title.

§ 290aa–4. Data collection
(a) Requirement of annual collection of data on
mental illness and substance abuse
The Secretary, acting through the Administrator, shall collect data each year on—
(1) the national incidence and prevalence of
the various forms of mental illness and substance abuse; and
(2) the incidence and prevalence of such various forms in major metropolitan areas selected by the Administrator.
(b) Requisite areas of data collection on mental
health
With respect to the activities of the Administrator under subsection (a) of this section relating to mental health, the Administrator shall
ensure that such activities include, at a minimum, the collection of data on—
(1) the number and variety of public and
nonprofit private treatment programs;
(2) the number and demographic characteristics of individuals receiving treatment
through such programs;
(3) the type of care received by such individuals; and
(4) such other data as may be appropriate.
(c) Requisite areas of data collection on substance abuse
(1) With respect to the activities of the Administrator under subsection (a) of this section relating to substance abuse, the Administrator
shall ensure that such activities include, at a
minimum, the collection of data on—
(A) the number of individuals admitted to
the emergency rooms of hospitals as a result
of the abuse of alcohol or other drugs;

§ 290aa–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the number of deaths occurring as a result of substance abuse, as indicated in reports
by coroners;
(C) the number and variety of public and private nonprofit treatment programs, including
the number and type of patient slots available;
(D) the number of individuals seeking treatment through such programs, the number and
demographic characteristics of individuals receiving such treatment, the percentage of individuals who complete such programs, and,
with respect to individuals receiving such
treatment, the length of time between an individual’s request for treatment and the commencement of treatment;
(E) the number of such individuals who return for treatment after the completion of a
prior treatment in such programs and the
method of treatment utilized during the prior
treatment;
(F) the number of individuals receiving public assistance for such treatment programs;
(G) the costs of the different types of treatment modalities for drug and alcohol abuse
and the aggregate relative costs of each such
treatment modality provided within a State in
each fiscal year;
(H) to the extent of available information,
the number of individuals receiving treatment
for alcohol or drug abuse who have private insurance coverage for the costs of such treatment;
(I) the extent of alcohol and drug abuse
among high school students and among the
general population; and
(J) the number of alcohol and drug abuse
counselors and other substance abuse treatment personnel employed in public and private
treatment facilities.
(2) Annual surveys shall be carried out in the
collection of data under this subsection. Summaries and analyses of the data collected shall
be made available to the public.
(d) Development of uniform criteria for data collection
After consultation with the States and with
appropriate national organizations, the Administrator shall develop uniform criteria for the
collection of data, using the best available technology, pursuant to this section.
(July 1, 1944, ch. 373, title V, § 505, formerly
§ 509D, as added Pub. L. 100–690, title II, § 2052(a),
Nov. 18, 1988, 102 Stat. 4207; amended Pub. L.
101–93, § 3(b), Aug. 16, 1989, 103 Stat. 609; renumbered § 505, Pub. L. 102–321, title I, § 105, July 10,
1992, 106 Stat. 334; Pub. L. 103–43, title XX,
§ 2010(b)(7), June 10, 1993, 107 Stat. 214.)
CODIFICATION
Section was formerly classified to section 290aa–11 of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 290aa–4, act July 1, 1944, ch. 373, title
V, § 506, formerly § 505, as added Apr. 26, 1983, Pub. L.
98–24, § 2(b)(7), 97 Stat. 178; renumbered § 506, Oct. 27,
1986, Pub. L. 99–570, title IV, § 4004(a), 100 Stat. 3207–109,
which related to reports on alcoholism and alcohol and
drug abuse, was renumbered section 503 of act July 1,
1944, by Pub. L. 102–321 and transferred to section
290aa–2 of this title.

Page 658

A prior section 505 of act July 1, 1944, was renumbered
section 502 by section 102 of Pub. L. 102–321 and is classified to section 290aa–1 of this title.
Another prior section 505 of act July 1, 1944, which
was classified to section 223 of this title, was renumbered section 2105 of act July 1, 1944, by Pub. L. 98–24
and transferred to section 300aa–4 of this title, renumbered section 2305 of act July 1, 1944, by Pub. L. 99–660
and transferred to section 300cc–4 of this title, prior to
repeal by Pub. L. 99–117, § 12(f), Oct. 7, 1985, 99 Stat. 495.
AMENDMENTS
1993—Pub. L. 103–43, § 2010(b)(7), which directed the
substitution of ‘‘section 238 of this title’’ for ‘‘section
300aaa of this title’’ in section 505(a)(2) of act July 1,
1944 (this section), could not be executed because the
language did not appear. Amendment was probably intended for prior section 505 which was renumbered section 502 and amended generally by Pub. L. 102–321, § 102,
which is classified to section 290aa–1 of this title.
1989—Subsec. (c)(1)(A). Pub. L. 101–93, § 3(b)(1), substituted ‘‘alcohol or’’ for ‘‘alcohol and’’.
Subsec. (c)(2). Pub. L. 101–93, § 3(b)(2), substituted
‘‘this subsection’’ for ‘‘this section’’.
NATIONAL SURVEY ON DRUG USE AND HEALTH
Pub. L. 108–358, § 5, Oct. 22, 2004, 118 Stat. 1664, provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services shall ensure that the National Survey
on Drug Use and Health includes questions concerning
the use of anabolic steroids.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
$1,000,000 for each of fiscal years 2005 through 2010.’’
REPORTS ON CONSUMPTION OF METHAMPHETAMINE AND
OTHER ILLICIT DRUGS
Pub. L. 106–310, div. B, title XXXVI, § 3641, Oct. 17,
2000, 114 Stat. 1237, provided that: ‘‘The Secretary of
Health and Human Services shall include in each National Household Survey on Drug Abuse appropriate
prevalence data and information on the consumption of
methamphetamine and other illicit drugs in rural
areas, metropolitan areas, and consolidated metropolitan areas.’’
PUBLIC HEALTH MONITORING OF METHAMPHETAMINE
ABUSE
Pub. L. 104–237, title V, § 502, Oct. 3, 1996, 110 Stat.
3112, provided that: ‘‘The Secretary of Health and
Human Services shall develop a public health monitoring program to monitor methamphetamine abuse in
the United States. The program shall include the collection and dissemination of data related to methamphetamine abuse which can be used by public health
officials in policy development.’’

§ 290aa–5. Grants for the benefit of homeless individuals
(a) In general
The Secretary shall award grants, contracts
and cooperative agreements to communitybased public and private nonprofit entities for
the purposes of providing mental health and
substance abuse services for homeless individuals. In carrying out this section, the Secretary
shall consult with the Interagency Council on
the Homeless 1, established under section 11311 of
this title.
(b) Preferences
In awarding grants, contracts, and cooperative
agreements under subsection (a) of this section,
the Secretary shall give a preference to—
1 See

Change of Name note below.

Page 659

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) entities that provide integrated primary
health, substance abuse, and mental health
services to homeless individuals;
(2) entities that demonstrate effectiveness in
serving runaway, homeless, and street youth;
(3) entities that have experience in providing
substance abuse and mental health services to
homeless individuals;
(4) entities that demonstrate experience in
providing housing for individuals in treatment
for or in recovery from mental illness or substance abuse; and
(5) entities that demonstrate effectiveness in
serving homeless veterans.
(c) Services for certain individuals
In awarding grants, contracts, and cooperative
agreements under subsection (a) of this section,
the Secretary shall not—
(1) prohibit the provision of services under
such subsection to homeless individuals who
are suffering from a substance abuse disorder
and are not suffering from a mental health
disorder; and
(2) make payments under subsection (a) of
this section to any entity that has a policy
of—
(A) excluding individuals from mental
health services due to the existence or suspicion of substance abuse; or
(B) has a policy of excluding individuals
from substance abuse services due to the existence or suspicion of mental illness.
(d) Term of the awards
No entity may receive a grant, contract, or cooperative agreement under subsection (a) of this
section for more than 5 years.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $50,000,000 for fiscal year
2001, and such sums as may be necessary for
each of the fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 506, formerly § 512,
as added Pub. L. 98–509, title II, § 206(a), Oct. 19,
1984, 98 Stat. 2361; amended Pub. L. 100–77, title
VI, § 613(a), (b), July 22, 1987, 101 Stat. 524; renumbered § 506 and amended Pub. L. 102–321, title
I, § 106, July 10, 1992, 106 Stat. 334; Pub. L.
106–310, div. B, title XXXII, § 3202, Oct. 17, 2000,
114 Stat. 1190; Pub. L. 106–400, § 2, Oct. 30, 2000,
114 Stat. 1675.)
CODIFICATION
Section was formerly classified to section 290bb–1a of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 290aa–5, act July 1, 1944, ch. 373, title
V, § 507, formerly § 506, as added Apr. 26, 1983, Pub. L.
98–24, § 2(b)(7), 97 Stat. 178; amended Nov. 20, 1985, Pub.
L. 99–158, § 3(c), 99 Stat. 879; renumbered § 507 and
amended Oct. 27, 1986, Pub. L. 99–570, title IV, §§ 4004(a),
4007, 100 Stat. 3207–109, 3207–115, which related to peer
review of biomedical and behavioral research and development grants, was renumbered section 504 of act July
1, 1944, by Pub. L. 102–321 and transferred to section
290aa–3 of this title.
A prior section 506 of act July 1, 1944, which was classified to section 224 of this title, was successively renumbered by subsequent acts, and transferred, see section 238c of this title.

§ 290aa–5a

AMENDMENTS
2000—Pub. L. 106–310 amended section catchline and
text generally, substituting present provisions for provisions, in subsec. (a), authorizing Secretary to make
grants for benefit of homeless individuals through the
Administrator of Substance Abuse and Mental Health
Services Administration, in subsec. (b), relating to
preferences for grants to entities providing integrated
primary health, substance abuse, and mental health
services, in subsec. (c), relating to services for certain
individuals, in subsec. (d), relating to 5-year grants
with renewals, and in subsec. (e), authorizing appropriations for fiscal years 1993 and 1994.
Subsec. (a). Pub. L. 106–400 made technical amendment to reference in original act which appears in text
as reference to section 11311 of this title.
1992—Pub. L. 102–321 amended section generally, substituting provisions relating to grants for benefit of
homeless individuals for provisions relating to alcohol
abuse and alcoholism demonstration projects.
1987—Subsecs. (c), (d). Pub. L. 100–77 added subsec. (c),
redesignated former subsec. (c) as (d), and substituted
‘‘subsection (a) or (c)’’ for ‘‘subsection (a)’’.
CHANGE OF NAME
Interagency Council on the Homeless changed to
United States Interagency Council on Homelessness by
Pub. L. 108–199, div. G, title II, § 216, Jan. 23, 2004, 118
Stat. 394.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290aa–5a. Alcohol and drug prevention or treatment services for Indians and Native Alaskans
(a) In general
The Secretary shall award grants, contracts,
or cooperative agreements to public and private
nonprofit entities, including Native Alaskan entities and Indian tribes and tribal organizations,
for the purpose of providing alcohol and drug
prevention or treatment services for Indians and
Native Alaskans.
(b) Priority
In awarding grants, contracts, or cooperative
agreements under subsection (a) of this section,
the Secretary shall give priority to applicants
that—
(1) propose to provide alcohol and drug prevention or treatment services on reservations;
(2) propose to employ culturally-appropriate
approaches, as determined by the Secretary,
in providing such services; and
(3) have provided prevention or treatment
services to Native Alaskan entities and Indian
tribes and tribal organizations for at least 1
year prior to applying for a grant under this
section.
(c) Duration
The Secretary shall award grants, contracts,
or cooperative agreements under subsection (a)
of this section for a period not to exceed 5 years.
(d) Application
An entity desiring a grant, contract, or cooperative agreement under subsection (a) of this
section shall submit an application to the Secretary at such time, in such manner, and accom-

§ 290aa–5b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

panied by such information as the Secretary
may reasonably require.
(e) Evaluation
An entity that receives a grant, contract, or
cooperative agreement under subsection (a) of
this section shall submit, in the application for
such grant, a plan for the evaluation of any
project undertaken with funds provided under
this section. Such entity shall provide the Secretary with periodic evaluations of the progress
of such project and such evaluation at the completion of such project as the Secretary determines to be appropriate. The final evaluation
submitted by such entity shall include a recommendation as to whether such project shall continue.
(f) Report
Not later than 3 years after October 17, 2000,
and annually thereafter, the Secretary shall prepare and submit, to the Committee on Health,
Education, Labor, and Pensions of the Senate, a
report describing the services provided pursuant
to this section.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $15,000,000 for fiscal year
2001, and such sums as may be necessary for fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 506A, as added
Pub. L. 106–310, div. B, title XXXIII, § 3306, Oct.
17, 2000, 114 Stat. 1215.)
§ 290aa–5b. Grants for ecstasy and other club
drugs abuse prevention
(a) Authority
The Administrator may make grants to, and
enter into contracts and cooperative agreements
with, public and nonprofit private entities to enable such entities—
(1) to carry out school-based programs concerning the dangers of the abuse of and addiction to 3,4-methylenedioxy methamphetamine,
related drugs, and other drugs commonly referred to as ‘‘club drugs’’ using methods that
are effective and science-based, including initiatives that give students the responsibility
to create their own anti-drug abuse education
programs for their schools; and
(2) to carry out community-based abuse and
addiction prevention programs relating to 3,4methylenedioxy methamphetamine, related
drugs, and other club drugs that are effective
and science-based.
(b) Use of funds
Amounts made available under a grant, contract or cooperative agreement under subsection
(a) of this section shall be used for planning, establishing, or administering prevention programs relating to 3,4-methylenedioxy methamphetamine, related drugs, and other club
drugs.
(c) Use of funds
(1) Discretionary functions
Amounts provided to an entity under this
section may be used—
(A) to carry out school-based programs
that are focused on those districts with high

Page 660

or increasing rates of abuse and addiction to
3,4-methylenedioxy methamphetamine, related drugs, and other club drugs and targeted at populations that are most at risk to
start abusing these drugs;
(B) to carry out community-based prevention programs that are focused on those populations within the community that are
most at-risk for abuse of and addiction to
3,4-methylenedioxy methamphetamine, related drugs, and other club drugs;
(C) to assist local government entities to
conduct appropriate prevention activities relating to 3,4-methylenedioxy methamphetamine, related drugs, and other club drugs;
(D) to train and educate State and local
law enforcement officials, prevention and
education officials, health professionals,
members of community anti-drug coalitions
and parents on the signs of abuse of and addiction to 3,4-methylenedioxy methamphetamine, related drugs, and other club drugs
and the options for treatment and prevention;
(E) for planning, administration, and educational activities related to the prevention
of
abuse
of
and
addiction
to
3,4methylenedioxy methamphetamine, related
drugs, and other club drugs;
(F) for the monitoring and evaluation of
prevention
activities
relating
to
3,4methylenedioxy methamphetamine, related
drugs, and other club drugs and reporting
and disseminating resulting information to
the public; and
(G) for targeted pilot programs with evaluation components to encourage innovation
and experimentation with new methodologies.
(2) Priority
The Administrator shall give priority in
awarding grants under this section to rural
and urban areas that are experiencing a high
rate or rapid increases in abuse and addiction
to 3,4-methylenedioxy methamphetamine, related drugs, and other club drugs.
(d) Allocation and report
(1) Prevention program allocation
Not less than $500,000 of the amount appropriated in each fiscal year to carry out this
section shall be made available to the Administrator, acting in consultation with other
Federal agencies, to support and conduct periodic analyses and evaluations of effective prevention programs for abuse of and addiction to
3,4-methylenedioxy methamphetamine, related drugs, and other club drugs and the development of appropriate strategies for disseminating information about and implementing
such programs.
(2) Report
The Administrator shall annually prepare
and submit to the Committee on Health, Education, Labor, and Pensions, the Committee
on the Judiciary, and the Committee on Appropriations of the Senate, and the Committee
on Commerce, the Committee on the Judiciary, and the Committee on Appropriations of
the House of Representatives, a report con-

Page 661

TITLE 42—THE PUBLIC HEALTH AND WELFARE §§ 290aa–12 to 290aa–14

taining the results of the analyses and evaluations conducted under paragraph (1).
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section—
(1) $10,000,000 for fiscal year 2001; and
(2) such sums as may be necessary for each
succeeding fiscal year.
(July 1, 1944, ch. 373, title V, § 506B, as added
Pub. L. 106–310, div. B, title XXXVI, § 3665(a),
Oct. 17, 2000, 114 Stat. 1244.)
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
FINDINGS
Pub. L. 106–310, div. B, title XXXVI, § 3662, Oct. 17,
2000, 114 Stat. 1241, provided that: ‘‘Congress makes the
following findings:
‘‘(1) The illegal importation of 3,4-methylenedioxy
methamphetamine, commonly referred to as ‘MDMA’
or ‘Ecstasy’ (referred to in this subtitle [subtitle C
(§§ 3661–3665) of title XXXVI of div. B of Pub. L.
106–310, see section 3661 of Pub. L. 106–310, set out as
a Short Title of 2000 Amendment note under section
201 of this title] as ‘Ecstasy’), has increased in recent
years, as evidenced by the fact that Ecstasy seizures
by the United States Customs Service have increased
from less than 500,000 tablets during fiscal year 1997
to more than 9,000,000 tablets during the first 9
months of fiscal year 2000.
‘‘(2) Use of Ecstasy can cause long-lasting, and perhaps permanent, damage to the serotonin system of
the brain, which is fundamental to the integration of
information and emotion, and this damage can cause
long-term problems with learning and memory.
‘‘(3) Due to the popularity and marketability of Ecstasy, there are numerous Internet websites with information on the effects of Ecstasy, the production of
Ecstasy, and the locations of Ecstasy use (often referred to as ‘raves’). The availability of this information targets the primary users of Ecstasy, who are
most often college students, young professionals, and
other young people from middle- to high-income families.
‘‘(4) Greater emphasis needs to be placed on—
‘‘(A) penalties associated with the manufacture,
distribution, and use of Ecstasy;
‘‘(B) the education of young people on the negative health effects of Ecstasy, since the reputation
of Ecstasy as a ‘safe’ drug is the most dangerous
component of Ecstasy;
‘‘(C) the education of State and local law enforcement agencies regarding the growing problem of
Ecstasy trafficking across the United States;
‘‘(D) reducing the number of deaths caused by Ecstasy use and the combined use of Ecstasy with
other ‘club’ drugs and alcohol; and
‘‘(E) adequate funding for research by the National Institute on Drug Abuse to—
‘‘(i) identify those most vulnerable to using Ecstasy and develop science-based prevention approaches tailored to the specific needs of individuals at high risk;
‘‘(ii) understand how Ecstasy produces its toxic
effects and how to reverse neurotoxic damage;
‘‘(iii) develop treatments, including new medications and behavioral treatment approaches;
‘‘(iv) better understand the effects that Ecstasy
has on the developing children and adolescents;
and

‘‘(v) translate research findings into useful
tools and ensure their effective dissemination.’’

§§ 290aa–6 to 290aa–8. Transferred
CODIFICATION
Section 290aa–6, act July 1, 1944, ch. 373, title V, § 508,
as added Oct. 27, 1986, Pub. L. 99–570, title IV, § 4005(a),
100 Stat. 3207–111, and amended, which related to the
Office of Substance Abuse Prevention, was renumbered
section 515 of act July 1, 1944, by Pub. L. 102–321, title
I, § 113(b), July 10, 1992, 106 Stat. 345, and transferred to
section 290bb–21 of this title.
Section 290aa–7, act July 1, 1944, ch. 373, title V, § 509,
as added Oct. 27, 1986, Pub. L. 99–570, title IV, § 4005(a),
100 Stat. 3207–112, which related to Alcohol and Drug
Abuse Information Clearinghouse, was renumbered section 516 of act July 1, 1944, by Pub. L. 102–321, title I,
§ 113(f)(1)–(3), July 10, 1992, 106 Stat. 345, and transferred
to section 290bb–22 of this title.
Section 290aa–8, act July 1, 1944, ch. 373, title V,
§ 509A, as added Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4005(a), 100 Stat. 3207–113, and amended, which related
to alcohol and drug abuse prevention, treatment, and
rehabilitation model projects for high risk youth, was
renumbered section 517 of act July 1, 1944, by Pub. L.
102–321, title I, § 114(a), July 10, 1992, 106 Stat. 346, and
transferred to section 290bb–23 of this title.

§§ 290aa–9, 290aa–10. Repealed. Pub. L. 102–321,
title I, § 120(a), July 10, 1992, 106 Stat. 358
Section 290aa–9, act July 1, 1944, ch. 373, title V,
§ 509B, as added Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4006, 100 Stat. 3207–114; amended Oct. 27, 1992, Pub. L.
102–531, title III, § 312(d)(11), 106 Stat. 3505, related to research on public health emergencies.
Section 290aa–10, act July 1, 1944, ch. 373, title V,
§ 509C, as added Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 420 [4020], 100 Stat. 3207–122, related to guidelines for
use of animals in research.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290aa–11. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title V, § 509D, as
added Nov. 18, 1988, Pub. L. 100–690, title II, § 2052(a), 102
Stat. 4207, and amended, which related to the collection
of data on mental illness and substance abuse, was renumbered section 505 of act July 1, 1944, by Pub. L.
102–321, title I, § 105, July 10, 1992, 106 Stat. 334, and
transferred to section 290aa–4 of this title.

§§ 290aa–12 to 290aa–14. Repealed. Pub. L.
102–321, title I, § 120(a), July 10, 1992, 106
Stat. 358
Section 290aa–12, act July 1, 1944, ch. 373, title V,
§ 509E, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2053, 102 Stat. 4208; amended Aug. 16, 1989, Pub. L.
101–93, § 3(c), 103 Stat. 610; Aug. 15, 1990, Pub. L. 101–374,
§ 2(a)–(c)(2), 104 Stat. 456, related to reduction of waiting periods for drug abuse treatment.
Section 290aa–13, act July 1, 1944, ch. 373, title V,
§ 509F, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2054, 102 Stat. 4209, related to model projects for pregnant and post partum women and their infants.
Section 290aa–14, act July 1, 1944, ch. 373, title V,
§ 509G, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2055, 102 Stat. 4210; amended Aug. 16, 1989, Pub. L.
101–93, § 3(d), 103 Stat. 610, related to drug abuse demonstration projects of national significance.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),

§ 290bb

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

PART B—CENTERS AND PROGRAMS
SUBPART 1—CENTER FOR SUBSTANCE ABUSE
TREATMENT

§ 290bb. Center for Substance Abuse Treatment
(a) Establishment
There is established in the Administration a
Center for Substance Abuse Treatment (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a Director
(hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
individuals with extensive experience or academic qualifications in the treatment of substance abuse or in the evaluation of substance
abuse treatment systems.
(b) Duties
The Director of the Center shall—
(1) administer the substance abuse treatment block grant program authorized in section 300x–21 of this title;
(2) ensure that emphasis is placed on children and adolescents in the development of
treatment programs;
(3) collaborate with the Attorney General to
develop programs to provide substance abuse
treatment services to individuals who have
had contact with the Justice system, especially adolescents;
(4) collaborate with the Director of the Center for Substance Abuse Prevention in order to
provide outreach services to identify individuals in need of treatment services, with emphasis on the provision of such services to
pregnant and postpartum women and their infants and to individuals who abuse drugs intravenously;
(5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the National Institute on Alcohol
Abuse and Alcoholism, and with the States to
promote the study, dissemination, and implementation of research findings that will improve the delivery and effectiveness of treatment services;
(6) collaborate with the Administrator of the
Health Resources and Services Administration
and the Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into the mainstream of
the health care system of the United States of
programs for providing treatment services;
(7) evaluate plans submitted by the States
pursuant to section 300x–32(a)(6) of this title in
order to determine whether the plans adequately provide for the availability, allocation, and effectiveness of treatment services;
(8) sponsor regional workshops on improving
the quality and availability of treatment services;
(9) provide technical assistance to public and
nonprofit private entities that provide treatment services, including technical assistance
with respect to the process of submitting to
the Director applications for any program of
grants or contracts carried out by the Director;

Page 662

(10) encourage the States to expand the
availability (relative to fiscal year 1992) of
programs
providing
treatment
services
through self-run, self-supported recovery
based on the programs of housing operated
pursuant to section 300x–25 of this title;
(11) carry out activities to educate individuals on the need for establishing treatment facilities within their communities;
(12) encourage public and private entities
that provide health insurance to provide benefits for outpatient treatment services and
other nonhospital-based treatment services;
(13) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which shall be carried out through grants, contracts, or cooperative agreements provided to public or nonprofit private entities; and
(14) in carrying out paragraph (13), assess the
quality, appropriateness, and costs of various
treatment forms for specific patient groups.
(c) Grants and contracts
In carrying out the duties established in subsection (b) of this section, the Director may
make grants to and enter into contracts and cooperative agreements with public and nonprofit
private entities.
(July 1, 1944, ch. 373, title V, § 507, as added Pub.
L. 102–321, title I, § 107(2), July 10, 1992, 106 Stat.
335; amended Pub. L. 106–310, div. B, title XXXI,
§ 3112(a), Oct. 17, 2000, 114 Stat. 1188; Pub. L.
108–173, title IX, § 900(e)(2)(B), Dec. 8, 2003, 117
Stat. 2372.)
PRIOR PROVISIONS
A prior section 290bb, act July 1, 1944, ch. 373, title V,
§ 510, formerly Pub. L. 91–616, title V, § 501, as added
Pub. L. 94–371, § 7, July 26, 1976, 90 Stat. 1038; amended
Pub. L. 95–622, title II, § 268(c), (d), Nov. 9, 1978, 92 Stat.
3437; Pub. L. 96–180, § 14, Jan. 2, 1980, 93 Stat. 1305; renumbered § 510 of act July 1, 1944, and amended Apr. 26,
1983, Pub. L. 98–24, § 2(b)(9), 97 Stat. 179; Oct. 19, 1984,
Pub. L. 98–509, title II, §§ 205(a)(1), 206(c)(1), 98 Stat. 2361,
2362, related to encouragement of alcohol abuse and alcoholism research, prior to repeal by Pub. L. 102–321,
§ 122(b)(1). Prior to repeal, section 510(b) of act July 1,
1944, was renumbered section 464H(b) by Pub. L. 102–321
and transferred to section 285n(b) of this title.
A prior section 507 of act July 1, 1944, which was classified to section 290aa–5 of this title, was renumbered
section 504 of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 290aa–3 of this title.
AMENDMENTS
2003—Subsec. (b)(6). Pub. L. 108–173 substituted ‘‘Centers for Medicare & Medicaid Services’’ for ‘‘Health
Care Financing Administration’’.
2000—Subsec. (b)(2) to (6). Pub. L. 106–310, § 3112(a)(1),
(2), added pars. (2) and (3) and redesignated former pars.
(2) to (4) as (4) to (6), respectively. Former pars. (5) and
(6) redesignated (7) and (8), respectively.
Subsec. (b)(7). Pub. L. 106–310, § 3112(a)(1), (3), redesignated par. (5) as (7) and substituted ‘‘services’’ for
‘‘services, and monitor the use of revolving loan funds
pursuant to section 300x–25 of this title’’. Former par.
(7) redesignated (9).
Subsec. (b)(8) to (12). Pub. L. 106–310, § 3112(a)(1), redesignated pars. (6) to (10) as (8) to (12), respectively.
Former pars. (11) and (12) redesignated (13) and (14), respectively.
Subsec. (b)(13). Pub. L. 106–310, § 3112(a)(1), (4), redesignated par. (11) as (13) and substituted ‘‘treatment,
which shall’’ for ‘‘treatment, including the effect of liv-

Page 663

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing in housing provided by programs established under
section 300x–25 of this title, which shall’’.
Subsec. (b)(14). Pub. L. 106–310, § 3112(a)(1), (5), redesignated par. (12) as (14) and substituted ‘‘paragraph (13)’’
for ‘‘paragraph (11)’’.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290bb–1. Residential treatment programs for
pregnant and postpartum women
(a) In general
The Director of the Center for Substance
Abuse Treatment shall provide awards of grants,
cooperative agreement, or contracts to public
and nonprofit private entities for the purpose of
providing to pregnant and postpartum women
treatment for substance abuse through programs in which, during the course of receiving
treatment—
(1) the women reside in facilities provided by
the programs;
(2) the minor children of the women reside
with the women in such facilities, if the
women so request; and
(3) the services described in subsection (d) of
this section are available to or on behalf of the
women.
(b) Availability of services for each participant
A funding agreement for an award under subsection (a) of this section for an applicant is
that, in the program operated pursuant to such
subsection—
(1) treatment services and each supplemental service will be available through the
applicant, either directly or through agreements with other public or nonprofit private
entities; and
(2) the services will be made available to
each woman admitted to the program.
(c) Individualized plan of services
A funding agreement for an award under subsection (a) of this section for an applicant is
that—
(1) in providing authorized services for an eligible woman pursuant to such subsection, the
applicant will, in consultation with the
women, prepare an individualized plan for the
provision to the woman of the services; and
(2) treatment services under the plan will include—
(A) individual, group, and family counseling, as appropriate, regarding substance
abuse; and
(B) follow-up services to assist the woman
in preventing a relapse into such abuse.
(d) Required supplemental services
In the case of an eligible woman, the services
referred to in subsection (a)(3) of this section are
as follows:
(1) Prenatal and postpartum health care.
(2) Referrals for necessary hospital services.
(3) For the infants and children of the
woman—
(A) pediatric health care, including treatment for any perinatal effects of maternal

§ 290bb–1

substance abuse and including screenings regarding the physical and mental development of the infants and children;
(B) counseling and other mental health
services, in the case of children; and
(C) comprehensive social services.
(4) Providing supervision of children during
periods in which the woman is engaged in
therapy or in other necessary health or rehabilitative activities.
(5) Training in parenting.
(6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
(7) Counseling on domestic violence and sexual abuse.
(8) Counseling on obtaining employment, including the importance of graduating from a
secondary school.
(9) Reasonable efforts to preserve and support the family units of the women, including
promoting the appropriate involvement of parents and others, and counseling the children of
the women.
(10) Planning for and counseling to assist reentry into society, both before and after discharge, including referrals to any public or
nonprofit private entities in the community
involved that provide services appropriate for
the women and the children of the women.
(11) Case management services, including—
(A) assessing the extent to which authorized services are appropriate for the women
and their children;
(B) in the case of the services that are appropriate, ensuring that the services are provided in a coordinated manner; and
(C) assistance in establishing eligibility
for assistance under Federal, State, and
local programs providing health services,
mental health services, housing services,
employment services, educational services,
or social services.
(e) Minimum qualifications for receipt of award
(1) Certification by relevant State agency
With respect to the principal agency of the
State involved that administers programs relating to substance abuse, the Director may
make an award under subsection (a) of this
section to an applicant only if the agency has
certified to the Director that—
(A) the applicant has the capacity to carry
out a program described in subsection (a) of
this section;
(B) the plans of the applicant for such a
program are consistent with the policies of
such agency regarding the treatment of substance abuse; and
(C) the applicant, or any entity through
which the applicant will provide authorized
services, meets all applicable State licensure
or certification requirements regarding the
provision of the services involved.
(2) Status as medicaid provider
(A) Subject to subparagraphs (B) and (C), the
Director may make an award under subsection
(a) of this section only if, in the case of any
authorized service that is available pursuant
to the State plan approved under title XIX of

§ 290bb–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Social Security Act [42 U.S.C. 1396 et seq.]
for the State involved—
(i) the applicant for the award will provide
the service directly, and the applicant has
entered into a participation agreement
under the State plan and is qualified to receive payments under such plan; or
(ii) the applicant will enter into an agreement with a public or nonprofit private entity under which the entity will provide the
service, and the entity has entered into such
a participation agreement plan and is qualified to receive such payments.
(B)(i) In the case of an entity making an
agreement pursuant to subparagraph (A)(ii)
regarding the provision of services, the requirement established in such subparagraph
regarding a participation agreement shall be
waived by the Director if the entity does not,
in providing health care services, impose a
charge or accept reimbursement available
from any third-party payor, including reimbursement under any insurance policy or
under any Federal or State health benefits
plan.
(ii) A determination by the Director of
whether an entity referred to in clause (i)
meets the criteria for a waiver under such
clause shall be made without regard to whether the entity accepts voluntary donations regarding the provision of services to the public.
(C) With respect to any authorized service
that is available pursuant to the State plan
described in subparagraph (A), the requirements established in such subparagraph shall
not apply to the provision of any such service
by an institution for mental diseases to an individual who has attained 21 years of age and
who has not attained 65 years of age. For purposes of the preceding sentence, the term ‘‘institution for mental diseases’’ has the meaning given such term in section 1905(i) of the
Social Security Act [42 U.S.C. 1396d(i)].
(f) Requirement of matching funds
(1) In general
With respect to the costs of the program to
be carried out by an applicant pursuant to
subsection (a) of this section, a funding agreement for an award under such subsection is
that the applicant will make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that—
(A) for the first fiscal year for which the
applicant receives payments under an award
under such subsection, is not less than $1 for
each $9 of Federal funds provided in the
award;
(B) for any second such fiscal year, is not
less than $1 for each $9 of Federal funds provided in the award; and
(C) for any subsequent such fiscal year, is
not less than $1 for each $3 of Federal funds
provided in the award.
(2) Determination of amount contributed
Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services. Amounts provided by the Federal Gov-

Page 664

ernment, or services assisted or subsidized to
any significant extent by the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
(g) Outreach
A funding agreement for an award under subsection (a) of this section for an applicant is
that the applicant will provide outreach services
in the community involved to identify women
who are engaging in substance abuse and to encourage the women to undergo treatment for
such abuse.
(h) Accessibility of program; cultural context of
services
A funding agreement for an award under subsection (a) of this section for an applicant is
that—
(1) the program operated pursuant to such
subsection will be operated at a location that
is accessible to low-income pregnant and postpartum women; and
(2) authorized services will be provided in
the language and the cultural context that is
most appropriate.
(i) Continuing education
A funding agreement for an award under subsection (a) of this section is that the applicant
involved will provide for continuing education
in treatment services for the individuals who
will provide treatment in the program to be operated by the applicant pursuant to such subsection.
(j) Imposition of charges
A funding agreement for an award under subsection (a) of this section for an applicant is
that, if a charge is imposed for the provision of
authorized services to on 1 behalf of an eligible
woman, such charge—
(1) will be made according to a schedule of
charges that is made available to the public;
(2) will be adjusted to reflect the income of
the woman involved; and
(3) will not be imposed on any such woman
with an income of less than 185 percent of the
official poverty line, as established by the Director of the Office for Management and Budget and revised by the Secretary in accordance
with section 9902(2) of this title.
(k) Reports to Director
A funding agreement for an award under subsection (a) of this section is that the applicant
involved will submit to the Director a report—
(1) describing the utilization and costs of
services provided under the award;
(2) specifying the number of women served,
the number of infants served, and the type and
costs of services provided; and
(3) providing such other information as the
Director determines to be appropriate.
(l) Requirement of application
The Director may make an award under subsection (a) of this section only if an application
for the award is submitted to the Director containing such agreements, and the application is
in such form, is made in such manner, and con1 So

in original. Probably should be preceded by ‘‘or’’.

Page 665

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tains such other agreements and such assurances and information as the Director determines to be necessary to carry out this section.
(m) Equitable allocation of awards
In making awards under subsection (a) of this
section, the Director shall ensure that the
awards are equitably allocated among the principal geographic regions of the United States,
subject to the availability of qualified applicants for the awards.
(n) Duration of award
The period during which payments are made
to an entity from an award under subsection (a)
of this section may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Director of the payments
and subject to the availability of appropriations
for the fiscal year involved to make the payments. This subsection may not be construed to
establish a limitation on the number of awards
under such subsection that may be made to an
entity.
(o) Evaluations; dissemination of findings
The Director shall, directly or through contract, provide for the conduct of evaluations of
programs carried out pursuant to subsection (a)
of this section. The Director shall disseminate
to the States the findings made as a result of
the evaluations.
(p) Reports to Congress
Not later than October 1, 1994, the Director
shall submit to the Committee on Energy and
Commerce of the House of Representatives, and
to the Committee on Labor and Human Resources of the Senate, a report describing programs carried out pursuant to this section.
Every 2 years thereafter, the Director shall prepare a report describing such programs carried
out during the preceding 2 years, and shall submit the report to the Administrator for inclusion in the biennial report under section
290aa(k) of this title. Each report under this subsection shall include a summary of any evaluations conducted under subsection (m) of this section during the period with respect to which the
report is prepared.
(q) Definitions
For purposes of this section:
(1) The term ‘‘authorized services’’ means
treatment services and supplemental services.
(2) The term ‘‘eligible woman’’ means a
woman who has been admitted to a program
operated pursuant to subsection (a) of this section.
(3) The term ‘‘funding agreement under subsection (a)’’ of this section, with respect to an
award under subsection (a) of this section,
means that the Director may make the award
only if the applicant makes the agreement involved.
(4) The term ‘‘treatment services’’ means
treatment for substance abuse, including the
counseling and services described in subsection (c)(2) of this section.
(5) The term ‘‘supplemental services’’ means
the services described in subsection (d) of this
section.

§ 290bb–1

(r) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary to fiscal years 2001
through 2003.
(July 1, 1944, ch. 373, title V, § 508, as added Pub.
L. 102–321, title I, § 108(a), July 10, 1992, 106 Stat.
336; amended Pub. L. 106–310, div. B, title
XXXIII, § 3301(a), Oct. 17, 2000, 114 Stat. 1207.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(e)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 290bb–1, act July 1, 1944, ch. 373, title
V, § 511, formerly Pub. L. 91–616, title V, § 503, formerly
§ 504, as added Pub. L. 94–371, § 7, July 26, 1976, 90 Stat.
1039; amended Pub. L. 95–622, title I, § 110(d), Nov. 9,
1978, 92 Stat. 3420; Pub. L. 96–180, § 16, Jan. 2, 1980, 93
Stat. 1305; renumbered § 503 of Pub. L. 91–616 and
amended Pub. L. 97–35, title IX, § 965(b), (c), Aug. 13,
1981, 95 Stat. 594; renumbered § 511 of act July 1, 1944,
and amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(9), 97
Stat. 179; Oct. 27, 1986, Pub. L. 99–570, title IV, § 4008, 100
Stat. 3207–115, which related to National Alcohol Research Centers and a mandatory grant for research of
the effects of alcohol on the elderly, was renumbered
section 464J of title IV of act July 1, 1944, by Pub. L.
102–321 and transferred to section 285n–2 of this title.
A prior section 508 of act July 1, 1944, which was classified to section 290aa–6 of this title, was renumbered
section 515 of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 290bb–21 of this title.
AMENDMENTS
2000—Subsec. (r). Pub. L. 106–310 reenacted heading
without change and amended text generally, substituting provisions authorizing appropriations for fiscal
years 2001 to 2003 for provisions authorizing appropriations for fiscal years 1993 and 1994 and authorizing appropriations from the special forfeiture fund of the Director of the Office of National Drug Control Policy.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
TRANSITIONAL AND SAVINGS PROVISIONS
Section 108(b) of Pub. L. 102–321 provided that:
‘‘(1) SAVINGS PROVISION FOR COMPLETION OF CURRENT
PROJECTS.—

§ 290bb–1a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(A) Subject to paragraph (2), in the case of any
project for which a grant under former section 509F
[former 42 U.S.C. 290aa–13] was provided for fiscal
year 1992, the Secretary of Health and Human Services may continue in effect the grant for fiscal year
1993 and subsequent fiscal years, subject to the duration of any such grant not exceeding the period determined by the Secretary in first approving the grant.
Subject to approval by the Administrator, such
grants may be administered by the Center for Substance Abuse Prevention.
‘‘(B) Subparagraph (A) shall apply with respect to a
project notwithstanding that the project is not eligible to receive a grant under current section 508 or 509
[42 U.S.C. 290bb–1, 290bb–2].
‘‘(2) LIMITATION ON FUNDING FOR CERTAIN PROJECTS.—
With respect to the amounts appropriated for any fiscal
year under current section 508, any such amounts appropriated in excess of the amount appropriated for fiscal year 1992 under former section 509F shall be available only for grants under current section 508.
‘‘(3) DEFINITIONS.—For purposes of this subsection:
‘‘(A) The term ‘former section 509F’ means section
509F of the Public Health Service Act [former 42
U.S.C. 290aa–13], as in effect for fiscal year 1992.
‘‘(B) The term ‘current section 508’ means section
508 of the Public Health Service Act [42 U.S.C.
290bb–1], as in effect for fiscal year 1993 and subsequent fiscal years.
‘‘(C) The term ‘current section 509’ means section
509 of the Public Health Service Act [42 U.S.C.
290bb–2], as in effect for fiscal year 1993 and subsequent fiscal years.’’

§ 290bb–1a. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title V, § 512, as
added Oct. 19, 1984, Pub. L. 98–509, title II, § 206(a), 98
Stat. 2361, and amended, which related to alcohol abuse
and alcoholism demonstration projects, was renumbered section 506 of act July 1, 1944, by Pub. L. 102–321,
title I, § 106(a), July 10, 1992, 106 Stat. 334, and transferred to section 290aa–5 of this title.

§ 290bb–2. Priority substance abuse treatment
needs of regional and national significance
(a) Projects
The Secretary shall address priority substance
abuse treatment needs of regional and national
significance (as determined under subsection (b)
of this section) through the provision of or
through assistance for—
(1) knowledge development and application
projects for treatment and rehabilitation and
the conduct or support of evaluations of such
projects;
(2) training and technical assistance; and
(3) targeted capacity response programs.
The Secretary may carry out the activities described in this section directly or through
grants or cooperative agreements with States,
political subdivisions of States, Indian tribes
and tribal organizations, other public or nonprofit private entities.
(b) Priority substance abuse treatment needs
(1) In general
Priority substance abuse treatment needs of
regional and national significance shall be determined by the Secretary after consultation
with States and other interested groups. The
Secretary shall meet with the States and interested groups on an annual basis to discuss
program priorities.

Page 666

(2) Special consideration
In developing program priorities under paragraph (1), the Secretary shall give special consideration to promoting the integration of
substance abuse treatment services into primary health care systems.
(c) Requirements
(1) In general
Recipients of grants, contracts, or cooperative agreements under this section shall comply with information and application requirements determined appropriate by the Secretary.
(2) Duration of award
With respect to a grant, contract, or cooperative agreement awarded under this section,
the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds
The Secretary may, for projects carried out
under subsection (a) of this section, require
that entities that apply for grants, contracts,
or cooperative agreements under that project
provide non-Federal matching funds, as determined appropriate by the Secretary, to ensure
the institutional commitment of the entity to
the projects funded under the grant, contract,
or cooperative agreement. Such non-Federal
matching funds may be provided directly or
through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment, or services.
(4) Maintenance of effort
With respect to activities for which a grant,
contract, or cooperative agreement is awarded
under this section, the Secretary may require
that recipients for specific projects under subsection (a) of this section agree to maintain
expenditures of non-Federal amounts for such
activities at a level that is not less than the
level of such expenditures maintained by the
entity for the fiscal year preceding the fiscal
year for which the entity receives such a
grant, contract, or cooperative agreement.
(d) Evaluation
The Secretary shall evaluate each project carried out under subsection (a)(1) of this section
and shall disseminate the findings with respect
to each such evaluation to appropriate public
and private entities.
(e) Information and education
The Secretary shall establish comprehensive
information and education programs to disseminate and apply the findings of the knowledge development and application, training and technical assistance programs, and targeted capacity response programs under this section to the
general public, to health professionals and other
interested groups. The Secretary shall make
every effort to provide linkages between the
findings of supported projects and State agencies responsible for carrying out substance
abuse prevention and treatment programs.
(f) Authorization of appropriation
There are authorized to be appropriated to
carry out this section, $300,000,000 for fiscal year

Page 667

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 290bb–6

2001 and such sums as may be necessary for each
of the fiscal years 2002 and 2003.

which is classified to section 3508(b) of Title 20, Education.

(July 1, 1944, ch. 373, title V, § 509, as added Pub.
L. 102–321, title I, § 108(a), July 10, 1992, 106 Stat.
341; amended Pub. L. 106–310, div. B, title
XXXIII, § 3301(b), Oct. 17, 2000, 114 Stat. 1207.)

§§ 290bb–3 to 290bb–5. Repealed. Pub. L. 106–310,
div. B, title XXXIII, § 3301(c)(1)–(3), Oct. 17,
2000, 114 Stat. 1209

PRIOR PROVISIONS
A prior section 290bb–2, act July 1, 1944, ch. 373, title
V, § 513, formerly § 512, formerly Pub. L. 91–616, title V,
§ 504, formerly § 503, as added Pub. L. 94–371, § 7, July 26,
1976, 90 Stat. 1039; amended Pub. L. 96–180, § 15, Jan. 2,
1980, 93 Stat. 1305; renumbered § 504 of Pub. L. 91–616 and
amended Pub. L. 97–35, title IX, § 965(a), (c), Aug. 13,
1981, 95 Stat. 594; Pub. L. 97–414, § 9(e), Jan. 4, 1983, 96
Stat. 2064; renumbered § 512 of act July 1, 1944, and
amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(9), 97 Stat.
179; renumbered § 513 and amended Oct. 19, 1984, Pub. L.
98–509, title II, §§ 206(a), 207(a), 98 Stat. 2361, 2362; Oct.
27, 1986, Pub. L. 99–570, title IV, § 4010(a), 100 Stat.
3207–115; July 22, 1987, Pub. L. 100–77, title VI, § 613(c),
101 Stat. 524; Nov. 4, 1988, Pub. L. 100–607, title VIII,
§ 822, 102 Stat. 3171; Nov. 7, 1988, Pub. L. 100–628, title VI,
§ 622, 102 Stat. 3244; Nov. 18, 1988, Pub. L. 100–690, title
II, § 2056(a), 102 Stat. 4211; Aug. 16, 1989, Pub. L. 101–93,
§ 5(t)(1), 103 Stat. 615; Nov. 29, 1990, Pub. L. 101–645, title
V, § 522, 104 Stat. 4734, authorized appropriations to
carry out alcohol abuse and alcoholism research, prior
to repeal by Pub. L. 102–321, § 122(d)[(e)].
A prior section 509 of act July 1, 1944, which was classified to section 290aa–7 of this title, was renumbered
section 516 of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 290bb–22 of this title.
AMENDMENTS
2000—Pub. L. 106–310 amended section catchline and
text generally, substituting provisions relating to priority substance abuse treatment needs of regional and
national significance for provisions relating to outpatient treatment programs for pregnant and postpartum women.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290bb–2a. Medical treatment of narcotics addiction; report to Congress
The Secretary of Health and Human Services,
after consultation with the Attorney General
and with national organizations representative
of persons with knowledge and experience in the
treatment of narcotic addicts, shall determine
the appropriate methods of professional practice
in the medical treatment of the narcotic addiction of various classes of narcotic addicts, and
shall report thereon from time to time to the
Congress.
(Pub. L. 91–513, title I, § 4, Oct. 27, 1970, 84 Stat.
1241; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979,
93 Stat. 695.)
CODIFICATION
Section was not enacted as part of the Public Health
Service Act which comprises this chapter.
Section was formerly classified to section 257a of this
title.
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted in text for ‘‘Secretary of Health, Education,
and Welfare’’ pursuant to section 509(b) of Pub. L. 96–88

Section 290bb–3, act July 1, 1944, ch. 373, title V, § 510,
as added Pub. L. 102–321, title I, § 109, July 10, 1992, 106
Stat. 342, related to demonstration projects of national
significance.
A prior section 510 of act July 1, 1944, was classified
to section 290bb of this title, prior to repeal by Pub. L.
102–321, § 122(b)(1). Prior to repeal, section 510(b) of act
July 1, 1944, was renumbered section 464H(b) by Pub. L.
102–321 and transferred to section 285n(b) of this title.
Another prior section 510 of act July 1, 1944, which
was classified to section 228 of this title, was successively renumbered by subsequent acts and transferred,
see section 238g of this title.
Section 290bb–4, act July 1, 1944, ch. 373, title V, § 511,
as added Pub. L. 102–321, title I, § 110, July 10, 1992, 106
Stat. 343, related to grants for substance abuse treatment in State and local criminal justice systems.
A prior section 511 of act July 1, 1944, which was classified to section 290bb–1 of this title, was renumbered
section 464J of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 285n–2 of this title.
Another prior section 511 of act July 1, 1944, which
was classified to section 229 of this title, was successively renumbered by subsequent acts and transferred,
see section 238h of this title.
Section 290bb–5, act July 1, 1944, ch. 373, title V, § 512,
as added Pub. L. 102–321, title I, § 111, July 10, 1992, 106
Stat. 344, related to training in provision of treatment
services.
A prior section 512 of act July 1, 1944, which was classified to section 290bb–1a of this title, was renumbered
section 506 of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 290aa–5 of this title.
Another prior section 512 of act July 1, 1944, was renumbered section 513 by Pub. L. 98–509 and classified to
section 290bb–2 of this title, prior to repeal by Pub. L.
102–321, § 122(d)[(e)].
Another prior section 512 of act July 1, 1944, which
was classified to section 229a of this title, was successively renumbered by subsequent acts and transferred,
see section 238i of this title.

§ 290bb–6. Action by Center for Substance Abuse
Treatment and States concerning military facilities
(a) Center for Substance Abuse Treatment
The Director of the Center for Substance
Abuse Treatment shall—
(1) coordinate with the agencies represented
on the Commission on Alternative Utilization
of Military Facilities the utilization of military facilities or parts thereof, as identified by
such Commission, established under the National Defense Authorization Act of 1989, that
could be utilized or renovated to house nonviolent persons for drug treatment purposes;
(2) notify State agencies responsible for the
oversight of drug abuse treatment entities and
programs of the availability of space at the installations identified in paragraph (1); and
(3) assist State agencies responsible for the
oversight of drug abuse treatment entities and
programs in developing methods for adapting
the installations described in paragraph (1)
into residential treatment centers.
(b) States
With regard to military facilities or parts
thereof, as identified by the Commission on Al-

§ 290bb–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ternative Utilization of Military Facilities established under section 3042 of the Comprehensive Alcohol Abuse, Drug Abuse, and Mental
Health Amendments Act of 1988,1 that could be
utilized or renovated to house nonviolent persons for drug treatment purposes, State agencies
responsible for the oversight of drug abuse
treatment entities and programs shall—
(1) establish eligibility criteria for the treatment of individuals at such facilities;
(2) select treatment providers to provide
drug abuse treatment at such facilities;
(3) provide assistance to treatment providers
selected under paragraph (2) to assist such providers in securing financing to fund the cost of
the programs at such facilities; and
(4) establish, regulate, and coordinate with
the military official in charge of the facility,
work programs for individuals receiving treatment at such facilities.
(c) Reservation of space
Prior to notifying States of the availability of
space at military facilities under subsection
(a)(2) of this section, the Director may reserve
space at such facilities to conduct research or
demonstration projects.
(July 1, 1944, ch. 373, title V, § 513, formerly § 561,
as added Pub. L. 100–690, title II, § 2081(a), Nov.
18, 1988, 102 Stat. 4215; renumbered § 513 and
amended Pub. L. 102–321, title I, § 112(a), (b)(1),
July 10, 1992, 106 Stat. 344, 345.)
REFERENCES IN TEXT
The National Defense Authorization Act of 1989, referred to in subsec. (a)(1), probably means the National
Defense Authorization Act, Fiscal Year 1989, Pub. L.
100–456, Sept. 29, 1988, 102 Stat. 1918. For complete classification of this Act to the Code, see Tables.
Section 3042 of the Comprehensive Alcohol Abuse,
Drug Abuse, and Mental Health Amendments Act of
1988, referred to in subsec. (b), probably should be a reference to section 2819 of the National Defense Authorization Act, Fiscal Year 1989, Pub. L. 100–456, div. B,
title XXVIII, Sept. 29, 1988, 102 Stat. 2119, which established the Commission on Alternative Utilization of
Military Facilities and which was set out as a note
under section 2391 of Title 10, Armed Forces, prior to
repeal by Pub. L. 105–261, div. A, title X, § 1031(b), Oct.
17, 1998, 112 Stat. 2123. The Comprehensive Alcohol
Abuse, Drug Abuse, and Mental Health Amendments
Act of 1988 is subtitle A of title II of Pub. L. 100–690,
Nov. 18, 1988, 102 Stat. 4193, and does not contain a section 3042.
CODIFICATION
Section was formerly classified to section 290ff of this
title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 513 of act July 1, 1944, was classified
to section 290bb–2 of this title prior to repeal by Pub.
L. 102–321, title I, § 122(d)[(e)], July 10, 1992, 106 Stat. 360.
Another prior section 513 of act July 1, 1944, which
was classified to section 229b of this title, was successively renumbered by subsequent acts and transferred,
see section 238j of this title.
AMENDMENTS
1992—Subsec. (a). Pub. L. 102–321, § 112(b)(1), substituted provisions relating to Center for Substance
Abuse Treatment for provisions relating to National
Institute on Drug Abuse in heading and text.
1 See

References in Text note below.

Page 668

EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290bb–7. Substance abuse treatment services
for children and adolescents
(a) In general
The Secretary shall award grants, contracts,
or cooperative agreements to public and private
nonprofit entities, including Native Alaskan entities and Indian tribes and tribal organizations,
for the purpose of providing substance abuse
treatment services for children and adolescents.
(b) Priority
In awarding grants, contracts, or cooperative
agreements under subsection (a) of this section,
the Secretary shall give priority to applicants
who propose to—
(1) apply evidenced-based and cost effective
methods for the treatment of substance abuse
among children and adolescents;
(2) coordinate the provision of treatment
services with other social service agencies in
the community, including educational, juvenile justice, child welfare, and mental health
agencies;
(3) provide a continuum of integrated treatment services, including case management, for
children and adolescents with substance abuse
disorders and their families;
(4) provide treatment that is gender-specific
and culturally appropriate;
(5) involve and work with families of children and adolescents receiving treatment;
(6) provide aftercare services for children
and adolescents and their families after completion of substance abuse treatment; and
(7) address the relationship between substance abuse and violence.
(c) Duration of grants
The Secretary shall award grants, contracts,
or cooperative agreements under subsection (a)
of this section for periods not to exceed 5 fiscal
years.
(d) Application
An entity desiring a grant, contract, or cooperative agreement under subsection (a) of this
section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary
may reasonably require.
(e) Evaluation
An entity that receives a grant, contract, or
cooperative agreement under subsection (a) of
this section shall submit, in the application for
such grant, contract, or cooperative agreement,
a plan for the evaluation of any project undertaken with funds provided under this section.
Such entity shall provide the Secretary with
periodic evaluations of the progress of such
project and such evaluation at the completion of
such project as the Secretary determines to be
appropriate.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $40,000,000 for fiscal year

Page 669

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2001, and such sums as may be necessary for fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 514, as added Pub.
L. 106–310, div. B, title XXXI, § 3104(a), Oct. 17,
2000, 114 Stat. 1171.)
CODIFICATION
Another section 514 of act July 1, 1944, is classified to
section 290bb–9 of this title.

§ 290bb–8. Early intervention services for children and adolescents
(a) In general
The Secretary shall award grants, contracts,
or cooperative agreements to public and private
nonprofit entities, including local educational
agencies (as defined in section 8801 of title 20),1
for the purpose of providing early intervention
substance abuse services for children and adolescents.
(b) Priority
In awarding grants, contracts, or cooperative
agreements under subsection (a) of this section,
the Secretary shall give priority to applicants
who demonstrate an ability to—
(1) screen for and assess substance use and
abuse by children and adolescents;
(2) make appropriate referrals for children
and adolescents who are in need of treatment
for substance abuse;
(3) provide early intervention services, including counseling and ancillary services, that
are designed to meet the developmental needs
of children and adolescents who are at risk for
substance abuse; and
(4) develop networks with the educational,
juvenile justice, social services, and other
agencies and organizations in the State or
local community involved that will work to
identify children and adolescents who are in
need of substance abuse treatment services.
(c) Condition
In awarding grants, contracts, or cooperative
agreements under subsection (a) of this section,
the Secretary shall ensure that such grants,
contracts, or cooperative agreements are allocated, subject to the availability of qualified applicants, among the principal geographic regions
of the United States, to Indian tribes and tribal
organizations, and to urban and rural areas.
(d) Duration of grants
The Secretary shall award grants, contracts,
or cooperative agreements under subsection (a)
of this section for periods not to exceed 5 fiscal
years.
(e) Application
An entity desiring a grant, contract, or cooperative agreement under subsection (a) of this
section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary
may reasonably require.
(f) Evaluation
An entity that receives a grant, contract, or
cooperative agreement under subsection (a) of
1 See

References in Text note below.

§ 290bb–9

this section shall submit, in the application for
such grant, contract, or cooperative agreement,
a plan for the evaluation of any project undertaken with funds provided under this section.
Such entity shall provide the Secretary with
periodic evaluations of the progress of such
project and such evaluation at the completion of
such project as the Secretary determines to be
appropriate.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $20,000,000 for fiscal year
2001, and such sums as may be necessary for fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 514A, as added
Pub. L. 106–310, div. B, title XXXI, § 3104(a), Oct.
17, 2000, 114 Stat. 1172.)
REFERENCES IN TEXT
Section 8801 of title 20, referred to in subsec. (a), was
repealed by Pub. L. 107–110, title X, § 1011(5)(C), Jan. 8,
2002, 115 Stat. 1986. See section 7801 of Title 20, Education.

§ 290bb–9. Methamphetamine and amphetamine
treatment initiative
(a) Grants
(1) Authority to make grants
The Director of the Center for Substance
Abuse Treatment may make grants to States
and Indian tribes recognized by the United
States that have a high rate, or have had a
rapid increase, in methamphetamine or amphetamine abuse or addiction in order to permit such States and Indian tribes to expand
activities in connection with the treatment of
methamphetamine or amphetamine abuser or
addiction in the specific geographical areas of
such States or Indian tribes, as the case may
be, where there is such a rate or has been such
an increase.
(2) Recipients
Any grants under paragraph (1) shall be directed to the substance abuse directors of the
States, and of the appropriate tribal government authorities of the Indian tribes, selected
by the Director to receive such grants.
(3) Nature of activities
Any activities under a grant under paragraph (1) shall be based on reliable scientific
evidence of their efficacy in the treatment of
methamphetamine or amphetamine abuse or
addiction.
(b) Geographic distribution
The Director shall ensure that grants under
subsection (a) of this section are distributed equitably among the various regions of the country and among rural, urban, and suburban areas
that are affected by methamphetamine or amphetamine abuse or addiction.
(c) Additional activities
The Director shall—
(1) evaluate the activities supported by
grants under subsection (a) of this section;
(2) disseminate widely such significant information derived from the evaluation as the Director considers appropriate to assist States,

§ 290bb–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Indian tribes, and private providers of treatment services for methamphetamine or amphetamine abuser or addiction in the treatment of methamphetamine or amphetamine
abuse or addiction; and
(3) provide States, Indian tribes, and such
providers with technical assistance in connection with the provision of such treatment.
(d) Authorization of appropriations
(1) In general
There are authorized to be appropriated to
carry out this section $10,000,000 for fiscal year
2000 and such sums as may be necessary for
each of fiscal years 2001 and 2002.
(2) Use of certain funds
Of the funds appropriated to carry out this
section in any fiscal year, the lesser of 5 percent of such funds or $1,000,000 shall be available to the Director for purposes of carrying
out subsection (c) of this section.
(July 1, 1944, ch. 373, title V, § 514, as added Pub.
L. 106–310, div. B, title XXXVI, § 3632, Oct. 17,
2000, 114 Stat. 1236.)
CODIFICATION
Another section 514 of act July 1, 1944, is classified to
section 290bb–7 of this title.
SUBPART 2—CENTER FOR SUBSTANCE ABUSE
PREVENTION

§ 290bb–21. Office for Substance Abuse Prevention
(a) Establishment; Director
There is established in the Administration an
Office for Substance Abuse Prevention (hereafter referred to in this part as the ‘‘Prevention
Center’’). The Office 1 shall be headed by a Director appointed by the Secretary from individuals
with extensive experience or academic qualifications in the prevention of drug or alcohol abuse.
(b) Duties of Director
The Director of the Prevention Center shall—
(1) sponsor regional workshops on the prevention of drug and alcohol abuse;
(2) coordinate the findings of research sponsored by agencies of the Service on the prevention of drug and alcohol abuse;
(3) develop effective drug and alcohol abuse
prevention literature (including literature on
the adverse effects of cocaine free base (known
as ‘‘crack’’));
(4) in cooperation with the Secretary of Education, assure the widespread dissemination of
prevention materials among States, political
subdivisions, and school systems;
(5) support clinical training programs for
substance abuse counselors and other health
professionals involved in drug abuse education, prevention,; 2
(6) in cooperation with the Director of the
Centers for Disease Control and Prevention,
develop educational materials to reduce the
risks of acquired immune deficiency syndrome
among intravenous drug abusers;
1 So

in original. Probably should be ‘‘Prevention Center’’.
in original. Probably should be ‘‘education and prevention;’’.
2 So

Page 670

(7) conduct training, technical assistance,
data collection, and evaluation activities of
programs supported under the Drug Free
Schools and Communities Act of 1986;
(8) support the development of model, innovative, community-based programs to discourage alcohol and drug abuse among young people;
(9) collaborate with the Attorney General of
the Department of Justice to develop programs to prevent drug abuse among high risk
youth;
(10) prepare for distribution documentary
films and public service announcements for
television and radio to educate the public, especially adolescent audiences, concerning the
dangers to health resulting from the consumption of alcohol and drugs and, to the extent
feasible, use appropriate private organizations
and business concerns in the preparation of
such announcements; and
(11) develop and support innovative demonstration programs designed to identify and
deter the improper use or abuse of anabolic
steroids by students, especially students in
secondary schools.
(c) Grants, contracts and cooperative agreements
The Director may make grants and enter into
contracts and cooperative agreements in carrying out subsection (b) of this section.
(d) National data base
The Director of the Prevention Center shall
establish a national data base providing information on programs for the prevention of substance abuse. The data base shall contain information appropriate for use by public entities
and information appropriate for use by nonprofit private entities.
(July 1, 1944, ch. 373, title V, § 515, formerly § 508,
as added Pub. L. 99–570, title IV, § 4005(a), Oct. 27,
1986, 100 Stat. 3207–111; amended Pub. L. 100–690,
title II, § 2051(a)–(c), Nov. 18, 1988, 102 Stat. 4206;
Pub. L. 101–93, § 3(a), Aug. 16, 1989, 103 Stat. 609;
Pub. L. 101–647, title XIX, § 1906, Nov. 29, 1990, 104
Stat. 4854; renumbered § 515 and amended Pub. L.
102–321, title I, § 113(b)–(e), July 10, 1992, 106 Stat.
345; Pub. L. 102–531, title III, § 312(d)(10), Oct. 27,
1992, 106 Stat. 3505; Pub. L. 106–310, div. B, title
XXXI, § 3112(b), Oct. 17, 2000, 114 Stat. 1188.)
REFERENCES IN TEXT
The Drug-Free Schools and Communities Act of 1986,
referred to in subsec. (b)(7), means title V of Pub. L.
89–10 as added by Pub. L. 100–297, title I, § 1001, Apr. 28,
1988, 102 Stat. 252, which was classified generally to
subchapter V (§ 3171 et seq.) of chapter 47 of Title 20,
Education, prior to the general amendment of Pub. L.
89–10 by Pub. L. 103–382, title I, § 101, Oct. 20, 1994, 108
Stat. 3519. For provisions relating to safe and drug-free
schools and communities, see section 7101 et seq. of
Title 20.
CODIFICATION
Section was formerly classified to section 290aa–6 of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 515 of act July 1, 1944, was classified
to section 290cc of this title, prior to repeal by Pub. L.
102–321, title I, § 123(c), July 10, 1992, 106 Stat. 363.
Another prior section 515 of act July 1, 1944, which
was classified to section 229d of this title, was succes-

Page 671

TITLE 42—THE PUBLIC HEALTH AND WELFARE

sively renumbered by subsequent acts and transferred,
see section 238l of this title.
AMENDMENTS
2000—Subsec. (b)(9). Pub. L. 106–310, § 3112(b)(2), added
par. (9). Former par. (9) redesignated (10).
Subsec. (b)(10). Pub. L. 106–310, § 3112(b)(1), (3), redesignated par. (9) as (10) and substituted ‘‘educate the public, especially adolescent audiences, concerning’’ for
‘‘educate the public concerning’’. Former par. (10) redesignated (11).
Subsec. (b)(11). Pub. L. 106–310, § 3112(b)(1), redesignated par. (10) as (11).
1992—Subsec. (a). Pub. L. 102–321, § 113(e)(1), substituted ‘‘(hereafter referred to in this part as the ‘Prevention Center’)’’ for ‘‘(hereafter in this part referred
to as the ‘Office’)’’.
Subsec. (b). Pub. L. 102–321, § 113(e)(2), substituted
‘‘Prevention Center’’ for ‘‘Office’’ in introductory provisions.
Subsec. (b)(5). Pub. L. 102–321, § 113(c)(1), struck out
‘‘and intervention’’ after ‘‘prevention,’’.
Subsec. (b)(6). Pub. L. 102–531, which directed the
amendment
of
‘‘section
508(b)(6)
(42
U.S.C.
290aa–6(b)(6))’’ of act July 1, 1944, by substituting ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’, was executed to subsec. (b)(6) of
this section to reflect the probable intent of Congress
and the intervening renumbering of section 508 of act
July 1, 1944, as section 515 of that act by Pub. L. 102–321,
§ 113(b)(2).
Subsec. (b)(9). Pub. L. 102–321, § 113(c)(4), inserted
‘‘and’’ after semicolon at end.
Subsec. (b)(10) to (12). Pub. L. 102–321, § 113(c)(2)–(4),
redesignated par. (12) as (10) and struck out former
pars. (10) and (11) which read as follows:
‘‘(10)(A) provide assistance to communities to develop
comprehensive long-term strategies for the prevention
of substance abuse; and
‘‘(B) evaluate the success of different community approaches toward the prevention of substance abuse;
‘‘(11) through schools of health professions, schools of
allied health professions, schools of nursing, and
schools of social work, carry out programs—
‘‘(A) to train individuals in the diagnosis and treatment of alcohol and drug abuse; and
‘‘(B) to develop appropriate curricula and materials
for the training described in subparagraph (A); and’’.
Subsec. (d). Pub. L. 102–321, § 113(d), amended subsec.
(d) generally. Prior to amendment, subsec. (d) read as
follows:
‘‘(1) For the purpose of carrying out this section and
sections 290aa–7, 290aa–8, and 290aa–13 of this title,
there are authorized to be appropriated $95,000,000 for
fiscal year 1989 and such sums as may be necessary for
each of the fiscal years 1990 and 1991.
‘‘(2) Of the amounts appropriated pursuant to paragraph (1) for a fiscal year, the Secretary shall make
available not less than $5,000,000 to carry out paragraphs (5) and (11) of subsection (b) of this section.’’
1990—Subsec. (b)(12). Pub. L. 101–647 added par. (12).
1989—Subsec. (b)(11)(B). Pub. L. 101–93, § 3(a)(2), substituted ‘‘subparagraph (A)’’ for ‘‘subparagraph (a)’’.
Subsec. (d)(1). Pub. L. 101–93, § 3(a)(1), inserted a
comma after ‘‘290aa–13 of this title’’.
1988—Subsec. (b)(5). Pub. L. 100–690, § 2051(b)(1),
amended par. (5) generally. Prior to amendment, par.
(5) read as follows: ‘‘support programs of clinical training of substance abuse counselors and other health professionals;’’.
Subsec. (b)(10). Pub. L. 100–690, § 2051(b)(2) added par.
(10).
Subsec. (b)(11). Pub. L. 100–690, § 2051(c), added par.
(11).
Subsec. (d). Pub. L. 100–690, § 2051(a), amended subsec.
(d) generally. Prior to amendment, subsec. (d) read as
follows: ‘‘Of the amounts available under the second
sentence of section 300y(a) of this title to carry out this
section and section 290aa–8 of this title, $20,000,000 shall
be available to carry out section 290aa–8 of this title.’’

§ 290bb–22

EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290bb–22. Priority substance abuse prevention
needs of regional and national significance
(a) Projects
The Secretary shall address priority substance
abuse prevention needs of regional and national
significance (as determined under subsection (b)
of this section) through the provision of or
through assistance for—
(1) knowledge development and application
projects for prevention and the conduct or support of evaluations of such projects;
(2) training and technical assistance; and
(3) targeted capacity response programs.
The Secretary may carry out the activities described in this section directly or through
grants or cooperative agreements with States,
political subdivisions of States, Indian tribes
and tribal organizations, or other public or nonprofit private entities.
(b) Priority substance abuse prevention needs
(1) In general
Priority substance abuse prevention needs of
regional and national significance shall be determined by the Secretary in consultation
with the States and other interested groups.
The Secretary shall meet with the States and
interested groups on an annual basis to discuss
program priorities.
(2) Special consideration
In developing program priorities under paragraph (1), the Secretary shall give special consideration to—
(A) applying the most promising strategies
and research-based primary prevention approaches; and
(B) promoting the integration of substance
abuse prevention information and activities
into primary health care systems.
(c) Requirements
(1) In general
Recipients of grants, contracts, and cooperative agreements under this section shall comply with information and application requirements determined appropriate by the Secretary.
(2) Duration of award
With respect to a grant, contract, or cooperative agreement awarded under this section,
the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds
The Secretary may, for projects carried out
under subsection (a) of this section, require
that entities that apply for grants, contracts,
or cooperative agreements under that project
provide non-Federal matching funds, as determined appropriate by the Secretary, to ensure
the institutional commitment of the entity to
the projects funded under the grant, contract,

§ 290bb–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or cooperative agreement. Such non-Federal
matching funds may be provided directly or
through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment, or services.
(4) Maintenance of effort
With respect to activities for which a grant,
contract, or cooperative agreement is awarded
under this section, the Secretary may require
that recipients for specific projects under subsection (a) of this section agree to maintain
expenditures of non-Federal amounts for such
activities at a level that is not less than the
level of such expenditures maintained by the
entity for the fiscal year preceding the fiscal
year for which the entity receives such a
grant, contract, or cooperative agreement.
(d) Evaluation
The Secretary shall evaluate each project carried out under subsection (a)(1) of this section
and shall disseminate the findings with respect
to each such evaluation to appropriate public
and private entities.
(e) Information and education
The Secretary shall establish comprehensive
information and education programs to disseminate the findings of the knowledge development
and application, training and technical assistance programs, and targeted capacity response
programs under this section to the general public and to health professionals. The Secretary
shall make every effort to provide linkages between the findings of supported projects and
State agencies responsible for carrying out substance abuse prevention and treatment programs.
(f) Authorization of appropriation
There are authorized to be appropriated to
carry out this section, $300,000,000 for fiscal year
2001, and such sums as may be necessary for
each of the fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 516, formerly § 509,
as added Pub. L. 99–570, title IV, § 4005(a), Oct. 27,
1986, 100 Stat. 3207–112; renumbered § 516 and
amended Pub. L. 102–321, title I, § 113(f), July 10,
1992, 106 Stat. 345; Pub. L. 106–310, div. B, title
XXXIII, § 3302(a), Oct. 17, 2000, 114 Stat. 1209.)
CODIFICATION
Section was formerly classified to section 290aa–7 of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 516 of act July 1, 1944, was classified
to section 290cc–1 of this title, prior to repeal by Pub.
L. 102–321, title I, § 123(c), July 10, 1992, 106 Stat. 363.
AMENDMENTS
2000—Pub. L. 106–310 amended section catchline and
text generally, substituting provisions relating to priority substance abuse prevention needs of regional and
national significance for provisions relating to community programs.
1992—Pub. L. 102–321, § 113(f)(4), amended section generally, substituting provisions relating to community
programs for provisions relating to alcohol and drug
abuse information clearinghouse.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assist-

Page 672

ance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290bb–23. Prevention, treatment, and rehabilitation model projects for high risk youth
(a) Grants to public and nonprofit private entities
The Secretary, through the Director of the
Prevention Center, shall make grants to public
and nonprofit private entities for projects to
demonstrate effective models for the prevention,
treatment, and rehabilitation of drug abuse and
alcohol abuse among high risk youth.
(b) Priority of projects
(1) In making grants for drug abuse and alcohol abuse prevention projects under this section,
the Secretary shall give priority to applications
for projects directed at children of substance
abusers, latchkey children, children at risk of
abuse or neglect, preschool children eligible for
services under the Head Start Act [42 U.S.C. 9831
et seq.], children at risk of dropping out of
school, children at risk of becoming adolescent
parents, and children who do not attend school
and who are at risk of being unemployed.
(2) In making grants for drug abuse and alcohol abuse treatment and rehabilitation projects
under this section, the Secretary shall give priority to projects which address the relationship
between drug abuse or alcohol abuse and physical child abuse, sexual child abuse, emotional
child abuse, dropping out of school, unemployment, delinquency, pregnancy, violence, suicide,
or mental health problems.
(3) In making grants under this section, the
Secretary shall give priority to applications
from community based organizations for
projects to develop innovative models with multiple, coordinated services for the prevention or
for the treatment and rehabilitation of drug
abuse or alcohol abuse by high risk youth.
(4) In making grants under this section, the
Secretary shall give priority to applications for
projects to demonstrate effective models with
multiple, coordinated services which may be
replicated and which are for the prevention or
for the treatment and rehabilitation of drug
abuse or alcohol abuse by high risk youth.
(5) In making grants under this section, the
Secretary shall give priority to applications
that employ research designs adequate for evaluating the effectiveness of the program.
(c) Strategies for reducing use
The Secretary shall ensure that projects under
subsection (a) of this section include strategies
for reducing the use of alcoholic beverages and
tobacco products by individuals to whom it is
unlawful to sell or distribute such beverages or
products.
(d) Regionally equal distribution of grants
To the extent feasible, the Secretary shall
make grants under this section in all regions of
the United States, and shall ensure the distribution of grants under this section among urban
and rural areas.
(e) Application for grants
In order to receive a grant for a project under
this section for a fiscal year, a public or non-

Page 673

TITLE 42—THE PUBLIC HEALTH AND WELFARE

profit private entity shall submit an application
to the Secretary, acting through the Office.1 The
Secretary may provide to the Governor of the
State the opportunity to review and comment
on such application. Such application shall be in
such form, shall contain such information, and
shall be submitted at such time as the Secretary
may by regulation prescribe.
(f) Evaluation of projects
The Director of the Office 1 shall evaluate
projects conducted with grants under this section.
(g) ‘‘High risk youth’’ defined
For purposes of this section, the term ‘‘high
risk youth’’ means an individual who has not attained the age of 21 years, who is at high risk of
becoming, or who has become, a drug abuser or
an alcohol abuser, and who—
(1) is identified as a child of a substance
abuser;
(2) is a victim of physical, sexual, or psychological abuse;
(3) has dropped out of school;
(4) has become pregnant;
(5) is economically disadvantaged;
(6) has committed a violent or delinquent
act;
(7) has experienced mental health problems;
(8) has attempted suicide;
(9) has experienced long-term physical pain
due to injury; or
(10) has experienced chronic failure in
school.
(h) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2003.
(July 1, 1944, ch. 373, title V, § 517, formerly
§ 509A, as added Pub. L. 99–570, title IV, § 4005(a),
Oct. 27, 1986, 100 Stat. 3207–113; amended Pub. L.
100–690, title II, § 2051(d), Nov. 18, 1988, 102 Stat.
4206; renumbered § 517 and amended Pub. L.
102–321, title I, § 114, July 10, 1992, 106 Stat. 346;
Pub. L. 106–310, div. B, title XXXI, § 3103, Oct. 17,
2000, 114 Stat. 1171.)
REFERENCES IN TEXT
The Head Start Act, referred to in subsec. (b)(1), is
subchapter B (§§ 635–657) of chapter 8 of subtitle A of
title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, as
amended, which is classified generally to subchapter II
(§ 9831 et seq.) of chapter 105 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 9801 of this title and Tables.
CODIFICATION
Section was formerly classified to section 290aa–8 of
this title prior to renumbering by Pub. L. 102–321.
PRIOR PROVISIONS
A prior section 517 of act July 1, 1944, was classified
to section 290cc–2 of this title, prior to repeal by Pub.
L. 102–321, title I, § 123(c), July 10, 1992, 106 Stat. 363.
AMENDMENTS
2000—Subsec. (h). Pub. L. 106–310 substituted ‘‘such
sums as may be necessary for each of the fiscal years
1 So

in original. Probably should be ‘‘Prevention Center’’.

§ 290bb–25

2001 through 2003’’ for ‘‘$70,000,000 for fiscal year 1993,
and such sums as may be necessary for fiscal year
1994’’.
1992—Subsec. (a). Pub. L. 102–321, § 114(d), substituted
‘‘Prevention Center’’ for ‘‘Office’’.
Subsecs. (c) to (g). Pub. L. 102–321, § 114(b), added subsec. (c) and redesignated former subsecs. (c) through (f)
as (d) through (g), respectively.
Subsec. (h). Pub. L. 102–321, § 114(c), added subsec. (h).
1988—Subsec. (b)(5). Pub. L. 100–690, § 2051(d)(1), added
par. (5).
Subsec. (f)(9). Pub. L. 100–690, § 2051(d)(2)(B), amended
par. (9) generally, substituting ‘‘has experienced longterm physical pain due to injury; or’’ for ‘‘is disabled
by injuries.’’
Subsec. (f)(10). Pub. L. 100–690, § 2051(d)(2)(C), added
par. (10).
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290bb–24. Repealed. Pub. L. 106–310, div. B, title
XXXIII, § 3302(b), Oct. 17, 2000, 114 Stat. 1210
Section, act July 1, 1944, ch. 373, title V, § 518, as
added Pub. L. 102–321, title I, § 171, July 10, 1992, 106
Stat. 377, related to employee assistance programs.
A prior section 518 of act July 1, 1944, was classified
to section 290cc–11 of this title, prior to repeal by Pub.
L. 102–321, § 120(b)(3).

§ 290bb–25. Grants for services for children of
substance abusers
(a) Establishment
(1) In general
The Secretary, acting through the Administrator of the Substance Abuse and Mental
Health Services Administration, shall make
grants to public and nonprofit private entities
for the purpose of carrying out programs—
(A) to provide the services described in
subsection (b) of this section to children of
substance abusers;
(B) to provide the applicable services described in subsection (c) of this section to
families in which a member is a substance
abuser;
(C) to identify such children and such families through youth service agencies, family
social services, child care providers, Head
Start, schools and after-school programs,
early childhood development programs, community-based family resource and support
centers, the criminal justice system, health,
substance abuse and mental health providers
through screenings conducted during regular
childhood examinations and other examinations, self and family member referrals, substance abuse treatment services, and other
providers of services to children and families; and
(D) to provide education and training to
health, substance abuse and mental health
professionals, and other providers of services
to children and families through youth service agencies, family social services, child
care, Head Start, schools and after-school
programs, early childhood development programs, community-based family resource
and support centers, the criminal justice
system, and other providers of services to
children and families.

§ 290bb–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Administrative consultations
The Administrator of the Administration for
Children, Youth, and Families and the Administrator of the Health Resources and Services
Administration shall be consulted regarding
the promulgation of program guidelines and
funding priorities under this section.
(3) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1)
only if, in the case of any service under such
paragraph that is covered in the State plan approved under title XIX of the Social Security
Act [42 U.S.C. 1396 et seq.] for the State involved—
(i)(I) the entity involved will provide the
service directly, and the entity has entered
into a participation agreement under the
State plan and is qualified to receive payments under such plan; or
(II) the entity will enter into an agreement with an organization under which the
organization will provide the service, and
the organization has entered into such a participation agreement and is qualified to receive such payments; and
(ii) the entity will identify children who
may be eligible for medical assistance under
a State program under title XIX or XXI of
the Social Security Act [42 U.S.C. 1396 et
seq., 1397aa et seq.].
(B)(i) In the case of an organization making
an agreement under subparagraph (A)(ii) 1 regarding the provision of services under paragraph (1), the requirement established in such
subparagraph regarding a participation agreement shall be waived by the Secretary if the
organization does not, in providing health or
mental health services, impose a charge or accept reimbursement available from any thirdparty payor, including reimbursement under
any insurance policy or under any Federal or
State health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the
public.
(b) Services for children of substance abusers
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees to make available (directly or
through agreements with other entities) to children of substance abusers each of the following
services:
(1) Periodic evaluation of children for developmental, psychological, alcohol and drug,
and medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental
health services.
(4) Therapeutic intervention services for
children, including provision of therapeutic
child care.
(5) Developmentally and age-appropriate
drug and alcohol early intervention, treatment and prevention services.
1 See

References in Text note below.

Page 674

(6) Counseling related to the witnessing of
chronic violence.
(7) Referrals for, and assistance in establishing eligibility for, services provided under—
(A) education and special education programs;
(B) Head Start programs established under
the Head Start Act [42 U.S.C. 9831 et seq.];
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by
Federal, State, or local governments; and
(F) programs offered by vocational rehabilitation agencies, recreation departments,
and housing agencies.
(8) Additional developmental services that
are consistent with the provision of early
intervention services, as such term is defined
in part C of the Individuals with Disabilities
Education Act [20 U.S.C. 1431 et seq.].
Services shall be provided under paragraphs (2)
through (8) by a public health nurse, social
worker, or similar professional, or by a trained
worker from the community who is supervised
by a professional, or by an entity, where the professional or entity provides assurances that the
professional or entity is licensed or certified by
the State if required and is complying with applicable licensure or certification requirements.
(c) Services for affected families
The Secretary may make a grant under subsection (a) of this section only if, in the case of
families in which a member is a substance
abuser, the applicant involved agrees to make
available (directly or through agreements with
other entities) each of the following services, as
applicable to the family member involved:
(1) Services as follows, to be provided by a
public health nurse, social worker, or similar
professional, or by a trained worker from the
community who is supervised by a professional, or by an entity, where the professional
or entity provides assurances that the professional or entity is licensed or certified by the
State if required and is complying with applicable licensure or certification requirements:
(A) Counseling to substance abusers on the
benefits and availability of substance abuse
treatment services and services for children
of substance abusers.
(B) Assistance to substance abusers in obtaining and using substance abuse treatment
services and in obtaining the services described in subsection (b) of this section for
their children.
(C) Visiting and providing support to substance abusers, especially pregnant women,
who are receiving substance abuse treatment services or whose children are receiving services under subsection (b) of this section.
(D) Aggressive outreach to family members with substance abuse problems.
(E) Inclusion of consumer in the development, implementation, and monitoring of
Family Services Plan.
(2) In the case of substance abusers:
(A) Alcohol and drug treatment services,
including screening and assessment, diag-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

nosis, detoxification, individual, group and
family
counseling,
relapse
prevention,
pharmacotherapy treatment, after-care services, and case management.
(B) Primary health care and mental health
services, including prenatal and post partum
care for pregnant women.
(C) Consultation and referral regarding
subsequent pregnancies and life options and
counseling on the human immunodeficiency
virus and acquired immune deficiency syndrome.
(D) Where appropriate, counseling regarding family violence.
(E) Career planning and education services.
(F) Referrals for, and assistance in establishing eligibility for, services described in
subsection (b)(7) of this section.
(3) In the case of substance abusers, spouses
of substance abusers, extended family members of substance abusers, caretakers of children of substance abusers, and other people
significantly involved in the lives of substance
abusers or the children of substance abusers:
(A) An assessment of the strengths and
service needs of the family and the assignment of a case manager who will coordinate
services for the family.
(B) Therapeutic intervention services,
such as parental counseling, joint counseling
sessions for families and children, and family therapy.
(C) Child care or other care for the child to
enable the parent to attend treatment or
other activities and respite care services.
(D) Parenting education services and parent support groups which include child abuse
and neglect prevention techniques.
(E) Support services, including, where appropriate, transportation services.
(F) Where appropriate, referral of other
family members to related services such as
job training.
(G) Aftercare services, including continued
support through parent groups and home visits.
(d) Training for providers of services to children
and families
The Secretary may make a grant under subsection (a) of this section for the training of
health, substance abuse and mental health professionals and other providers of services to children and families through youth service agencies, family social services, child care providers,
Head Start, schools and after-school programs,
early childhood development programs, community-based family resource centers, the criminal
justice system, and other providers of services
to children and families. Such training shall be
to assist professionals in recognizing the drug
and alcohol problems of their clients and to enhance their skills in identifying and understanding the nature of substance abuse, and obtaining
substance abuse early intervention, prevention
and treatment resources.
(e) Eligible entities
The Secretary shall distribute the grants
through the following types of entities:

§ 290bb–25

(1) Alcohol and drug early intervention, prevention or treatment programs, especially
those providing treatment to pregnant women
and mothers and their children.
(2) Public or nonprofit private entities that
provide health or social services to disadvantaged populations, and that have—
(A) expertise in applying the services to
the particular problems of substance abusers
and the children of substance abusers; or
(B) an affiliation or contractual relationship with one or more substance abuse treatment programs or pediatric health or mental
health providers and family mental health
providers.
(3) Consortia of public or nonprofit private
entities that include at least one substance
abuse treatment program.
(4) Indian tribes.
(f) Federal share
The Federal share of a program carried out
under subsection (a) of this section shall be 90
percent. The Secretary shall accept the value of
in-kind contributions, including facilities and
personnel, made by the grant recipient as a part
or all of the non-Federal share of grants.
(g) Restrictions on use of grant
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other
than minor remodeling) any building or other
facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition
for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private
entity.
(h) Submission to Secretary of certain information
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved submits to the Secretary—
(1) a description of the population that is to
receive services under this section and a description of such services that are to be provided and measurable goals and objectives;
(2) a description of the mechanism that will
be used to involve the local public agencies responsible for health, including maternal and
child health 2 mental health, child welfare,
education, juvenile justice, developmental disabilities, and substance abuse in planning and
providing services under this section, as well
as evidence that the proposal has been coordinated with the State agencies responsible for
administering those programs, the State agency responsible for administering alcohol and
drug programs, the State lead agency, and the
2 So

in original. Probably should be followed by a comma.

§ 290bb–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State Interagency Coordinating Council under
part H 3 of the Individuals with Disabilities
Education Act; and; 4
(3) such other information as the Secretary
determines to be appropriate.
(i) Reports to Secretary
The Secretary may make a grant under subsection (a) of this section only if the applicant
involved agrees that for each fiscal year for
which the applicant receives such a grant the
applicant, in accordance with uniform standards
developed by the Secretary, will submit to the
Secretary a report containing—
(1) a description of specific services and activities provided under the grant;
(2) information regarding progress toward
meeting the program’s stated goals and objectives;
(3) information concerning the extent of use
of services provided under the grant, including
the number of referrals to related services and
information on other programs or services accessed by children, parents, and other caretakers;
(4) information concerning the extent to
which parents were able to access and receive
treatment for alcohol and drug abuse and sustain participation in treatment over time
until the provider and the individual receiving
treatment agree to end such treatment, and
the extent to which parents re-enter treatment after the successful or unsuccessful termination of treatment;
(5) information concerning the costs of the
services provided and the source of financing
for health care services;
(6) information concerning—
(A) the number and characteristics of families, parents, and children served, including
a description of the type and severity of
childhood disabilities, and an analysis of the
number of children served by age;
(B) the number of children served who remained with their parents during the period
in which entities provided services under
this section; and
(C) the number of case workers or other
professionals trained to identify and address
substance abuse issues.
(7) information on hospitalization or emergency room use by the family members participating in the program; and
(8) such other information as the Secretary
determines to be appropriate.
(j) Requirement of application
The Secretary may make any grant under subsection (a) of this section only if—
(1) an application for the grant is submitted
to the Secretary;
(2) the application contains the agreements
required in this section and the information
required in subsection (h) of this section; and
(3) the application is in such form, is made
in such manner, and contains such agreements, assurances, and information as the
References in Text note below.
in original. The semicolon probably should not appear
after ‘‘and’’.

Page 676

Secretary determines to be necessary to carry
out this section.
(k) Evaluations
The Secretary shall periodically conduct evaluations to determine the effectiveness of programs supported under subsection (a) of this section—
(1) in reducing the incidence of alcohol and
drug abuse among substance abusers participating in the programs;
(2) in preventing adverse health conditions
in children of substance abusers;
(3) in promoting better utilization of health
and developmental services and improving the
health, developmental, and psychological
status of children receiving services under the
program; and
(4) in improving parental and family functioning, including increased participation in
work or employment-related activities and decreased participation in welfare programs.
(l) Report to Congress
Not later than 2 years after the date on which
amounts are first appropriated under subjection 5 (o) of this section, the Secretary shall prepare and submit to the Committee on Energy
and Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources of the Senate, a report that contains a
description of programs carried out under this
section. At a minimum, the report shall contain—
(1) information concerning the number and
type of programs receiving grants;
(2) information concerning the type and use
of services offered; and
(3) information concerning—
(A) the number and characteristics of families, parents, and children served; and
(B) the number of children served who remained with their parents during or after
the period in which entities provided services under this section.
analyzed by the type of entity described in
subsection (e) of this section that provided
services; 6
(m) Data collection
The Secretary shall periodically collect and
report on information concerning the numbers
of children in substance abusing families, including information on the age, gender and ethnicity of the children, the composition and income of the family, and the source of health
care finances. The periodic report shall include
a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
the child welfare system, the barriers to treatment and prevention services facing these families, and policy recommendations for removing
the identified barriers, including training for
child welfare workers.
(n) Definitions
For purposes of this section:
(1) The term ‘‘caretaker’’, with respect to a
child of a substance abuser, means any indi-

3 See
4 So

5 So
6 So

in original. Probably should be ‘‘subsection’’.
in original. The semicolon probably should be a period.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

vidual acting in a parental role regarding the
child (including any birth parent, foster parent, adoptive parent, relative of such a child,
or other individual acting in such a role).
(2) The term ‘‘children of substance abusers’’
means—
(A) children who have lived or are living in
a household with a substance abuser who is
acting in a parental role regarding the children; and
(B) children who have been prenatally exposed to alcohol or other drugs.
(3) The term ‘‘Indian tribe’’ means any tribe,
band, nation, or other organized group or community of Indians, including any Alaska Native village (as defined in, or established pursuant to, the Alaska Native Claims Settlement Act [43 U.S.C. 1601 et seq.]), that is recognized as eligible for the special programs
and services provided by the United States to
Indians because of their status as Indians.
(4) The term ‘‘public or nonprofit private entities that provide health or social services to
disadvantaged populations’’ includes community-based organizations, local public health
departments, community action agencies, hospitals, community health centers, child welfare agencies, developmental disabilities service providers, and family resource and support
programs.
(5) The term ‘‘substance abuse’’ means the
abuse of alcohol or other drugs.
(o) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$50,000,000 for fiscal year 2001, and such sums as
may be necessary for each of fiscal years 2002
and 2003.
(July 1, 1944, ch. 373, title V, § 519, formerly title
III, § 399D, as added Pub. L. 102–321, title IV,
§ 401(a), July 10, 1992, 106 Stat. 419; renumbered
§ 399A, renumbered title V, § 519, and amended
Pub. L. 106–310, div. A, title V, § 502(1), div. B,
title XXXI, § 3106(a)–(m), Oct. 17, 2000, 114 Stat.
1115, 1175–1179; Pub. L. 108–446, title III, § 305(i)(1),
(3), Dec. 3, 2004, 118 Stat. 2806.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(a)(3)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles XIX and XXI of the Act are classified
generally to subchapters XIX (§ 1396 et seq.) and XXI
(§ 1397aa et seq.), respectively, of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
Subparagraph
(A)(ii),
referred
to
in
subsec.
(a)(3)(B)(i), meaning subsec. (a)(3)(A)(ii) of this section
was redesignated as subsec. (a)(3)(A)(i)(II) and a new
subsec. (a)(3)(A)(ii) was added by Pub. L. 106–310, div. B,
title XXXI, § 3106(a)(3)(B)(i), (C), Oct. 17, 2000, 114 Stat.
1176.
The Head Start Act, referred to in subsec. (b)(7)(B), is
subchapter B (§§ 635–657) of chapter 8 of subtitle A of
title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, as
amended, which is classified generally to subchapter II
(§ 9831 et seq.) of chapter 105 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 9801 of this title and Tables.
The Individuals with Disabilities Education Act, referred to in subsecs. (b)(8) and (h)(2), is title VI of Pub.
L. 91–230, Apr. 13, 1970, 84 Stat. 175, as amended. Part C
of the Act is classified generally to subchapter III

§ 290bb–25

(§ 1431 et seq.) of chapter 33 of Title 20, Education. Part
H of the Act was classified generally to subchapter VIII
(§ 1471 et seq.) of chapter 33 of Title 20, prior to repeal
by Pub. L. 105–17, title II, § 203(b), June 4, 1997, 111 Stat.
157, effective July 1, 1998. For complete classification of
this Act to the Code, see section 1400 of Title 20 and
Tables.
The Alaska Native Claims Settlement Act, referred
to in subsec. (n)(3), is Pub. L. 92–203, Dec. 18, 1971, 85
Stat. 688, as amended, which is classified generally to
chapter 33 (§ 1601 et seq.) of Title 43, Public Lands. For
complete classification of this Act to the Code, see
Short Title note set out under section 1601 of Title 43
and Tables.
CODIFICATION
Section was formerly classified to section 280d of this
title.
AMENDMENTS
2004—Subsecs. (b)(8), (f). Pub. L. 108–446, § 305(i)(1), (3),
which directed amendment of subsecs. (b)(8) and (f) of
section 399A of the Public Health Service Act by substituting ‘‘part C’’ for ‘‘part H’’, was executed to subsec. (b)(8) of this section, which is section 519 of the
Public Health Service Act, to reflect the probable intent of Congress and the renumbering of this section
and repeal of former subsec. (f). See 2000 Amendments
notes below.
2000—Pub. L. 106–310, § 3106(a)–(m), which directed numerous amendments to section 399D of the Public
Health Service Act and the subsequent renumbering of
that section as section 519 of title V of the Act, was executed by amending this section and renumbering this
section as section 519 of title V, to reflect the probable
intent of Congress, notwithstanding the intervening renumbering of this section as section 399A of the Act by
section 502(1) of Pub. L. 106–310. See source credit above
and notes below.
Subsec. (a)(1). Pub. L. 106–310, § 3106(a)(1)(A), substituted ‘‘Administrator of the Substance Abuse and
Mental Health Services Administration’’ for ‘‘Administrator of the Health Resources and Services Administration’’ in introductory provisions.
Subsec. (a)(1)(B). Pub. L. 106–310, § 3106(a)(2)(A),
struck out ‘‘and’’ at end.
Subsec. (a)(1)(C). Pub. L. 106–310, § 3106(a)(2)(B), substituted ‘‘through youth service agencies, family social
services, child care providers, Head Start, schools and
after-school programs, early childhood development
programs, community-based family resource and support centers, the criminal justice system, health, substance abuse and mental health providers through
screenings conducted during regular childhood examinations and other examinations, self and family member referrals, substance abuse treatment services, and
other providers of services to children and families;
and’’ for period at end.
Subsec. (a)(1)(D). Pub. L. 106–310, § 3106(a)(2)(C), added
subpar. (D).
Subsec. (a)(2). Pub. L. 106–310, § 3106(a)(1)(B), substituted ‘‘Administrator of the Health Resources and
Services Administration’’ for ‘‘Administrator of the
Substance Abuse and Mental Health Services Administration’’.
Subsec. (a)(3)(A). Pub. L. 106–310, § 3106(a)(3), redesignated cls. (i) and (ii) as subcls. (I) and (II), respectively,
of cl. (i) and added cl. (ii).
Subsec. (b). Pub. L. 106–310, § 3106(b)(3), inserted concluding provisions.
Subsec. (b)(1). Pub. L. 106–310, § 3106(b)(1), inserted
‘‘alcohol and drug,’’ after ‘‘psychological,’’.
Subsec. (b)(5). Pub. L. 106–310, § 3106(b)(2), added par.
(5) and struck out former par. (5) relating to preventive
counseling services.
Subsec. (c)(1). Pub. L. 106–310, § 3106(c)(1)(A), inserted
‘‘, or by an entity, where the professional or entity provides assurances that the professional or entity is licensed or certified by the State if required and is com-

§ 290bb–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

plying with applicable licensure or certification requirements’’ before colon in introductory provisions.
Subsec. (c)(1)(D), (E). Pub. L. 106–310, § 3106(c)(1)(B),
added subpars. (D) and (E).
Subsec. (c)(2)(A). Pub. L. 106–310, § 3106(c)(2)(A), added
subpar. (A) and struck out former subpar. (A) relating
to encouragement to participate in and referrals to appropriate substance abuse treatment.
Subsec. (c)(2)(C). Pub. L. 106–310, § 3106(c)(2)(B), which
directed substitution of ‘‘and counseling on the human
immunodeficiency virus and acquired immune deficiency syndrome’’ for ‘‘, including educational and career planning’’, was executed by making the substitution for ‘‘, including education and career planning’’
to reflect the probable intent of Congress.
Subsec. (c)(2)(D). Pub. L. 106–310, § 3106(c)(2)(C), struck
out ‘‘conflict and’’ before ‘‘violence’’.
Subsec. (c)(2)(E). Pub. L. 106–310, § 3106(c)(2)(D), substituted ‘‘Career planning and education services’’ for
‘‘Remedial education services’’.
Subsec. (c)(3)(D). Pub. L. 106–310, § 3106(c)(3), inserted
‘‘which include child abuse and neglect prevention
techniques’’ before period at end.
Subsec. (d). Pub. L. 106–310, § 3106(l)(3), (4), added subsec. (d) and redesignated former subsec. (d) as (e).
Pub. L. 106–310, § 3106(d)(1), substituted ‘‘Eligible entities’’ for ‘‘Considerations in making grants’’ in heading
and ‘‘The Secretary shall distribute the grants through
the following types of entities:’’ for ‘‘In making grants
under subsection (a) of this section, the Secretary shall
ensure that the grants are reasonably distributed
among the following types of entities:’’ in introductory
provisions.
Subsec. (d)(1). Pub. L. 106–310, § 3106(d)(2), substituted
‘‘drug early intervention, prevention or treatment programs’’ for ‘‘drug treatment programs’’.
Subsec. (d)(2)(A). Pub. L. 106–310, § 3106(d)(3)(A), substituted ‘‘; or’’ for ‘‘; and’’.
Subsec. (d)(2)(B). Pub. L. 106–310, § 3106(d)(3)(B), inserted ‘‘or pediatric health or mental health providers
and family mental health providers’’ before period at
end.
Subsec. (e). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (d) as (e). Former subsec. (e) redesignated (f).
Subsec. (f). Pub. L. 106–310, § 3106(l)(1), (3), redesignated subsec. (e) as (f) and struck out former subsec. (f)
relating to coordination with other providers.
Subsec. (h)(2). Pub. L. 106–310, § 3106(e)(1), inserted
‘‘including maternal and child health’’ before ‘‘mental
health’’, struck out ‘‘treatment programs’’ after ‘‘substance abuse’’, and substituted ‘‘, the State agency responsible for administering alcohol and drug programs,
the State lead agency, and the State Interagency Coordinating Council under part H of the Individuals with
Disabilities Education Act; and’’ for ‘‘and the State
agency responsible for administering public maternal
and child health services’’.
Subsec. (h)(3), (4). Pub. L. 106–310, § 3106(e)(2), redesignated par. (4) as (3) and struck out former par. (3) relating to requirement to submit to Secretary information
demonstrating that the applicant has established a collaborative relationship with child welfare agencies and
child protective services.
Subsec. (i)(6)(B). Pub. L. 106–310, § 3106(f)(1), inserted
‘‘and’’ at end.
Subsec. (i)(6)(C). Pub. L. 106–310, § 3106(f)(2), added subpar. (C) and struck out former subpar. (C) relating to
the number of children served who were placed in outof-home care during the period in which entities provided services under section.
Subsec. (i)(6)(D), (E). Pub. L. 106–310, § 3106(f)(2),
struck out subpars. (D) and (E) relating to the number
of children described in subparagraph (C) who were reunited with their families and the number of children
described in subparagraph (C) for whom a permanent
plan has not been made or for whom the permanent
plan is other than family reunification, respectively.
Subsec. (k). Pub. L. 106–310, § 3106(l)(2), (3), redesignated subsec. (l) as (k) and struck out former subsec.
(k) relating to peer review.

Page 678

Subsec. (k)(2). Pub. L. 106–310, § 3106(l)(5), which directed amendment of subsec. (k)(2) of this section by
substituting ‘‘(i)’’ for ‘‘(h)’’, could not be executed because ‘‘(h)’’ does not appear in subsec. (k)(2).
Subsec. (l). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (m) as (l). Former subsec. (l) redesignated (k).
Subsec. (l)(3). Pub. L. 106–310, § 3106(l)(6), which directed substitution of ‘‘(e)’’ for ‘‘(d)’’ in subsec.
(m)(3)(E), was executed by making the substitution in
concluding provisions of subsec. (l)(3) to reflect the
probable intent of Congress and the amendment by
Pub. L. 106–310, § 3106(l)(3). See above.
Pub. L. 106–310, § 3106(g)(1), inserted ‘‘and’’ at end.
Subsec. (l)(4). Pub. L. 106–310, § 3106(g)(2), substituted
‘‘, including increased participation in work or employment-related activities and decreased participation in
welfare programs.’’ for semicolon at end.
Subsec. (l)(5), (6). Pub. L. 106–310, § 3106(g)(3), struck
out pars. (5) and (6) relating to reducing the incidence
of out-of-home placement for children whose parents
receive services under the program and facilitating the
reunification of families after children have been
placed in out-of-home care, respectively.
Subsec. (m). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (n) as (m). Former subsec. (m) redesignated (l).
Subsec. (m)(2). Pub. L. 106–310, § 3106(h)(1), inserted
‘‘and’’ at end.
Subsec. (m)(3)(A). Pub. L. 106–310, § 3106(h)(2)(A), inserted ‘‘and’’ at end.
Subsec. (m)(3)(B). Pub. L. 106–310, § 3106(h)(2)(B), substituted period for semicolon at end.
Subsec. (m)(3)(C) to (E). Pub. L. 106–310, § 3106(h)(2)(C),
struck out subpars. (C) to (E) relating to the number of
children served who were placed in out-of-home care
during the period in which entities provided services
under this section, the number of children described in
subparagraph (C) who were reunited with their families, and the number of children described in subparagraph (C) who were permanently placed in out-of-home
care, respectively.
Subsec. (m)(4). Pub. L. 106–310, § 3106(h)(3), struck out
par. (4) relating to an analysis of the access provided
to, and use of, related services and alcohol and drug
treatment through programs carried out under this section.
Subsec. (m)(5). Pub. L. 106–310, § 3106(l)(6), which directed amendment of subsec. (m)(5) by substituting
‘‘(e)’’ for ‘‘(d)’’, could not be executed because subsec.
(m) did not contain a par. (5) or a reference to ‘‘(d)’’
subsequent to the amendments by Pub. L. 106–310,
§ 3106(h)(3), (l)(3). See notes above and below.
Pub. L. 106–310, § 3106(h)(3), struck out par. (5) relating
to a comparison of the costs of providing services
through each of the types of entities described in subsection (d) of this section.
Subsec. (n). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (o) as (n). Former subsec. (n) redesignated (m).
Pub. L. 106–310, § 3106(i), inserted at end ‘‘The periodic
report shall include a quantitative estimate of the
prevalence of alcohol and drug problems in families involved in the child welfare system, the barriers to
treatment and prevention services facing these families, and policy recommendations for removing the
identified barriers, including training for child welfare
workers.’’
Subsec. (o). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (p) as (o). Former subsec. (o) redesignated (n).
Subsec. (o)(2)(B). Pub. L. 106–310, § 3106(j), struck out
‘‘dangerous’’ before ‘‘drugs’’.
Subsec. (p). Pub. L. 106–310, § 3106(l)(3), redesignated
subsec. (p) as (o).
Pub. L. 106–310, § 3106(k), amended heading and text of
subsec. (p) generally, substituting provisions relating
to authorization of appropriations for provisions relating to funding for carrying out section.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE
Section effective July 10, 1992, with programs making
awards providing financial assistance in fiscal year 1993
and subsequent years effective for awards made on or
after Oct. 1, 1992, see section 801(b), (d)(1) of Pub. L.
102–321, set out as an Effective Date of 1992 Amendment
note under section 236 of this title.
CONSTRUCTION
Section 401(b) of Pub. L. 102–321 provided that: ‘‘With
respect to the program established in section 399D [now
519] of the Public Health Service Act [this section] (as
added by subsection (a) of this section), nothing in such
section 399D may be construed as establishing for any
other Federal program any requirement, authority, or
prohibition, including with respect to recipients of
funds under such other Federal programs.’’
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.

§ 290bb–25a. Grants for strengthening families
(a) Program authorized
The Secretary, acting through the Director of
the Prevention Center, may make grants to public and nonprofit private entities to develop and
implement model substance abuse prevention
programs to provide early intervention and substance abuse prevention services for individuals
of high-risk families and the communities in
which such individuals reside.
(b) Priority
In awarding grants under subsection (a) of this
section, the Secretary shall give priority to applicants that—
(1) have proven experience in preventing substance abuse by individuals of high-risk families and reducing substance abuse in communities of such individuals;
(2) have demonstrated the capacity to implement community-based partnership initiatives
that are sensitive to the diverse backgrounds
of individuals of high-risk families and the
communities of such individuals;
(3) have experience in providing technical assistance to support substance abuse prevention programs that are community-based;
(4) have demonstrated the capacity to implement research-based substance abuse prevention strategies; and
(5) have implemented programs that involve
families, residents, community agencies, and
institutions in the implementation and design
of such programs.

§ 290bb–25a

(c) Duration of grants
The Secretary shall award grants under subsection (a) of this section for a period not to exceed 5 years.
(d) Use of funds
An applicant that is awarded a grant under
subsection (a) of this section shall—
(1) in the first fiscal year that such funds are
received under the grant, use such funds to develop a model substance abuse prevention program; and
(2) in the fiscal year following the first fiscal
year that such funds are received, use such
funds to implement the program developed
under paragraph (1) to provide early intervention and substance abuse prevention services
to—
(A) strengthen the environment of children of high risk families by targeting interventions at the families of such children and
the communities in which such children reside;
(B) strengthen protective factors, such
as—
(i) positive adult role models;
(ii) messages that oppose substance
abuse;
(iii) community actions designed to reduce accessibility to and use of illegal substances; and
(iv) willingness of individuals of families
in which substance abuse occurs to seek
treatment for substance abuse;
(C) reduce family and community risks,
such as family violence, alcohol or drug
abuse, crime, and other behaviors that may
effect healthy child development and increase the likelihood of substance abuse; and
(D) build collaborative and formal partnerships between community agencies, institutions, and businesses to ensure that comprehensive high quality services are provided,
such as early childhood education, health
care, family support programs, parent education programs, and home visits for infants.
(e) Application
To be eligible to receive a grant under subsection (a) of this section, an applicant shall
prepare and submit to the Secretary an application that—
(1) describes a model substance abuse prevention program that such applicant will establish;
(2) describes the manner in which the services described in subsection (d)(2) of this section will be provided; and
(3) describe 1 in as much detail as possible
the results that the entity expects to achieve
in implementing such a program.
(f) Matching funding
The Secretary may not make a grant to a 2 entity under subsection (a) of this section unless
that entity agrees that, with respect to the
costs to be incurred by the entity in carrying
out the program for which the grant was award1 So
2 So

in original. Probably should be ‘‘describes’’.
in original. Probably should be ‘‘an’’.

§ 290bb–25b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ed, the entity will make available non-Federal
contributions in an amount that is not less than
40 percent of the amount provided under the
grant.
(g) Report to Secretary
An applicant that is awarded a grant under
subsection (a) of this section shall prepare and
submit to the Secretary a report in such form
and containing such information as the Secretary may require, including an assessment of
the efficacy of the model substance abuse prevention program implemented by the applicant
and the short, intermediate, and long term results of such program.
(h) Evaluations
The Secretary shall conduct evaluations,
based in part on the reports submitted under
subsection (g) of this section, to determine the
effectiveness of the programs funded under subsection (a) of this section in reducing substance
use in high-risk families and in making communities in which such families reside in stronger.
The Secretary shall submit such evaluations to
the appropriate committees of Congress.
(i) High-risk families
In this section, the term ‘‘high-risk family’’
means a family in which the individuals of such
family are at a significant risk of using or abusing alcohol or any illegal substance.
(j) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $3,000,000 for fiscal year
2001, and such sums as may be necessary for
each of the fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 519A, as added
Pub. L. 106–310, div. B, title XXXI, § 3108, Oct. 17,
2000, 114 Stat. 1180.)
§ 290bb–25b. Programs to reduce underage drinking
(a) Definitions
For purposes of this section:
(1) The term ‘‘alcohol beverage industry’’
means the brewers, vintners, distillers, importers, distributors, and retail or online outlets that sell or serve beer, wine, and distilled
spirits.
(2) The term ‘‘school-based prevention’’
means programs, which are institutionalized,
and run by staff members or school-designated
persons or organizations in any grade of
school, kindergarten through 12th grade.
(3) The term ‘‘youth’’ means persons under
the age of 21.
(4) The term ‘‘IOM report’’ means the report
released in September 2003 by the National Research Council, Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collective Responsibility’’.
(b) Sense of Congress
It is the sense of the Congress that:
(1) A multi-faceted effort is needed to more
successfully address the problem of underage
drinking in the United States. A coordinated
approach to prevention, intervention, treatment, enforcement, and research is key to
making progress. This chapter recognizes the

Page 680

need for a focused national effort, and addresses particulars of the Federal portion of that
effort, as well as Federal support for State activities.
(2) The Secretary of Health and Human
Services shall continue to conduct research
and collect data on the short and long-range
impact of alcohol use and abuse upon adolescent brain development and other organ systems.
(3) States and communities, including colleges and universities, are encouraged to adopt
comprehensive prevention approaches, including—
(A) evidence-based screening, programs
and curricula;
(B) brief intervention strategies;
(C) consistent policy enforcement; and
(D) environmental changes that limit underage access to alcohol.
(4) Public health groups, consumer groups,
and the alcohol beverage industry should continue and expand evidence-based efforts to prevent and reduce underage drinking.
(5) The entertainment industries have a powerful impact on youth, and they should use
rating systems and marketing codes to reduce
the likelihood that underage audiences will be
exposed to movies, recordings, or television
programs with unsuitable alcohol content.
(6) The National Collegiate Athletic Association, its member colleges and universities, and
athletic conferences should affirm a commitment to a policy of discouraging alcohol use
among underage students and other young
fans.
(7) Alcohol is a unique product and should be
regulated differently than other products by
the States and Federal Government. States
have primary authority to regulate alcohol
distribution and sale, and the Federal Government should support and supplement these
State efforts. States also have a responsibility
to fight youth access to alcohol and reduce underage drinking. Continued State regulation
and licensing of the manufacture, importation, sale, distribution, transportation and
storage of alcoholic beverages are clearly in
the public interest and are critical to promoting responsible consumption, preventing illegal access to alcohol by persons under 21 years
of age from commercial and non-commercial
sources, maintaining industry integrity and
an orderly marketplace, and furthering effective State tax collection.
(c) Interagency coordinating committee; annual
report on State underage drinking prevention and enforcement activities
(1) Interagency coordinating committee on the
prevention of underage drinking
(A) In general
The Secretary, in collaboration with the
Federal officials specified in subparagraph
(B), shall formally establish and enhance the
efforts of the interagency coordinating committee, that began operating in 2004, focusing on underage drinking (referred to in this
subsection as the ‘‘Committee’’).
(B) Other agencies
The officials referred to in paragraph (1)
are the Secretary of Education, the Attor-

Page 681

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ney General, the Secretary of Transportation, the Secretary of the Treasury, the
Secretary of Defense, the Surgeon General,
the Director of the Centers for Disease Control and Prevention, the Director of the National Institute on Alcohol Abuse and Alcoholism, the Administrator of the Substance
Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, the Assistant Secretary
for Children and Families, the Director of
the Office of National Drug Control Policy,
the Administrator of the National Highway
Traffic Safety Administration, the Administrator of the Office of Juvenile Justice and
Delinquency Prevention, the Chairman of
the Federal Trade Commission, and such
other Federal officials as the Secretary of
Health and Human Services determines to be
appropriate.
(C) Chair
The Secretary of Health and Human Services shall serve as the chair of the Committee.
(D) Duties
The Committee shall guide policy and program development across the Federal Government with respect to underage drinking,
provided, however, that nothing in this section shall be construed as transferring regulatory or program authority from an Agency
to the Coordinating Committee.
(E) Consultations
The Committee shall actively seek the
input of and shall consult with all appropriate and interested parties, including
States, public health research and interest
groups, foundations, and alcohol beverage
industry trade associations and companies.
(F) Annual report
(i) In general
The Secretary, on behalf of the Committee, shall annually submit to the Congress
a report that summarizes—
(I) all programs and policies of Federal
agencies designed to prevent and reduce
underage drinking;
(II) the extent of progress in preventing and reducing underage drinking nationally;
(III) data that the Secretary shall collect with respect to the information
specified in clause (ii); and
(IV) such other information regarding
underage drinking as the Secretary determines to be appropriate.
(ii) Certain information
The report under clause (i) shall include
information on the following:
(I) Patterns and consequences of underage drinking as reported in research and
surveys such as, but not limited to Monitoring the Future, Youth Risk Behavior
Surveillance System, the National Survey on Drug Use and Health, and the Fatality Analysis Reporting System.
(II) Measures of the availability of alcohol from commercial and non-commercial sources to underage populations.

§ 290bb–25b

(III) Measures of the exposure of underage populations to messages regarding
alcohol in advertising and the entertainment media as reported by the Federal
Trade Commission.
(IV) Surveillance data, including information on the onset and prevalence of
underage drinking, consumption patterns and the means of underage access.
The Secretary shall develop a plan to
improve the collection, measurement
and consistency of reporting Federal underage alcohol data.
(V) Any additional findings resulting
from research conducted or supported
under subsection (f).
(VI) Evidence-based best practices to
prevent and reduce underage drinking
and provide treatment services to those
youth who need them.
(2) Annual report on state underage drinking
prevention and enforcement activities
(A) In general
The Secretary shall, with input and collaboration from other appropriate Federal
agencies, States, Indian tribes, territories,
and public health, consumer, and alcohol
beverage industry groups, annually issue a
report on each State’s performance in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking.
(B) State performance measures
(i) In general
The Secretary shall develop, in consultation with the Committee, a set of measures to be used in preparing the report on
best practices.
(ii) Categories
In developing these measures, the Secretary shall consider categories including,
but not limited to:
(I) Whether or not the State has comprehensive anti-underage drinking laws
such as for the illegal sale, purchase, attempt to purchase, consumption, or possession of alcohol; illegal use of fraudulent ID; illegal furnishing or obtaining of
alcohol for an individual under 21 years;
the degree of strictness of the penalties
for such offenses; and the prevalence of
the enforcement of each of these infractions.
(II) Whether or not the State has comprehensive liability statutes pertaining
to underage access to alcohol such as
dram shop, social host, and house party
laws, and the prevalence of enforcement
of each of these laws.
(III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
access to alcohol at retail outlets, such
as random compliance checks and shoulder tap programs, and the number of
compliance checks within alcohol retail
outlets measured against the number of
total alcohol retail outlets in each
State, and the result of such checks.

§ 290bb–25b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(IV) Whether or not the State encourages training on the proper selling and
serving of alcohol for all sellers and servers of alcohol as a condition of employment.
(V) Whether or not the State has policies and regulations with regard to direct sales to consumers and home delivery of alcoholic beverages.
(VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the number of adults targeted by these programs.
(VII) Whether or not the State has programs targeted to youths, parents, and
caregivers to deter underage drinking;
and the number of individuals served by
these programs.
(VIII) Whether or not the State has enacted graduated drivers licenses and the
extent of those provisions.
(IX) The amount that the State invests, per youth capita, on the prevention of underage drinking, further broken down by the amount spent on—
(aa) compliance check programs in
retail outlets, including providing
technology to prevent and detect the
use of false identification by minors to
make alcohol purchases;
(bb) checkpoints and saturation patrols that include the goal of reducing
and deterring underage drinking;
(cc) community-based, school-based,
and higher-education-based programs
to prevent underage drinking;
(dd) underage drinking prevention
programs that target youth within the
juvenile justice and child welfare systems; and
(ee) other State efforts or programs
as deemed appropriate.
(3) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection $1,000,000 for fiscal
year 2007, and $1,000,000 for each of the fiscal
years 2008 through 2010.
(d) National media campaign to prevent underage drinking
(1) Scope of the campaign
The Secretary shall continue to fund and
oversee the production, broadcasting, and
evaluation of the national adult-oriented
media public service campaign if the Secretary determines that such campaign is effective in achieving the media campaign’s measurable objectives.
(2) Report
The Secretary shall provide a report to the
Congress annually detailing the production,
broadcasting, and evaluation of the campaign
referred to in paragraph (1), and to detail in
the report the effectiveness of the campaign in
reducing underage drinking, the need for and
likely effectiveness of an expanded adult-oriented media campaign, and the feasibility and
the likely effectiveness of a national youth-focused media campaign to combat underage
drinking.

Page 682

(3) Consultation requirement
In carrying out the media campaign, the
Secretary shall direct the entity carrying out
the national adult-oriented media public service campaign to consult with interested parties including both the alcohol beverage industry and public health and consumer groups.
The progress of this consultative process is to
be covered in the report under paragraph (2).
(4) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection, $1,000,000 for fiscal
year 2007 and $1,000,000 for each of the fiscal
years 2008 through 2010.
(e) Interventions
(1) Community-based coalition enhancement
grants to prevent underage drinking
(A) Authorization of program
The Administrator of the Substance Abuse
and Mental Health Services Administration,
in consultation with the Director of the Office of National Drug Control Policy, shall
award, if the Administrator determines that
the Department of Health and Human Services is not currently conducting activities
that duplicate activities of the type described in this subsection, ‘‘enhancement
grants’’ to eligible entities to design, test,
evaluate and disseminate effective strategies to maximize the effectiveness of community-wide approaches to preventing and
reducing underage drinking. This subsection
is subject to the availability of appropriations.
(B) Purposes
The purposes of this paragraph are to—
(i) prevent and reduce alcohol use among
youth in communities throughout the
United States;
(ii) strengthen collaboration among communities, the Federal Government, and
State, local, and tribal governments;
(iii) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;
(iv) serve as a catalyst for increased citizen participation and greater collaboration among all sectors and organizations
of a community that first demonstrates a
long-term commitment to reducing alcohol use among youth;
(v) disseminate to communities timely
information
regarding
state-of-the-art
practices and initiatives that have proven
to be effective in preventing and reducing
alcohol use among youth; and
(vi) enhance, not supplant, effective
local community initiatives for preventing
and reducing alcohol use among youth.
(C) Application
An eligible entity desiring an enhancement grant under this paragraph shall submit an application to the Administrator at
such time, and in such manner, and accompanied by such information as the Administrator may require. Each application shall
include—

Page 683

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) a complete description of the entity’s
current underage alcohol use prevention
initiatives and how the grant will appropriately enhance the focus on underage
drinking issues; or
(ii) a complete description of the entity’s
current initiatives, and how it will use this
grant to enhance those initiatives by adding a focus on underage drinking prevention.
(D) Uses of funds
Each eligible entity that receives a grant
under this paragraph shall use the grant
funds to carry out the activities described in
such entity’s application submitted pursuant to subparagraph (C). Grants under this
paragraph shall not exceed $50,000 per year
and may not exceed four years.
(E) Supplement not supplant
Grant funds provided under this paragraph
shall be used to supplement, not supplant,
Federal and non-Federal funds available for
carrying out the activities described in this
paragraph.
(F) Evaluation
Grants under this paragraph shall be subject to the same evaluation requirements
and procedures as the evaluation requirements and procedures imposed on recipients
of drug free community grants.
(G) Definitions
For purposes of this paragraph, the term
‘‘eligible entity’’ means an organization that
is currently receiving or has received grant
funds under the Drug-Free Communities Act
of 1997 (21 U.S.C. 1521 et seq.).
(H) Administrative expenses
Not more than 6 percent of a grant under
this paragraph may be expended for administrative expenses.
(I) Authorization of appropriations
There are authorized to be appropriated to
carry out this paragraph $5,000,000 for fiscal
year 2007, and $5,000,000 for each of the fiscal
years 2008 through 2010.
(2) Grants directed at preventing and reducing
alcohol abuse at institutions of higher education
(A) Authorization of program
The Secretary shall award grants to eligible entities to enable the entities to prevent
and reduce the rate of underage alcohol consumption including binge drinking among
students at institutions of higher education.
(B) Applications
An eligible entity that desires to receive a
grant under this paragraph shall submit an
application to the Secretary at such time, in
such manner, and accompanied by such information as the Secretary may require.
Each application shall include—
(i) a description of how the eligible entity will work to enhance an existing, or
where none exists to build a, statewide coalition;

§ 290bb–25b

(ii) a description of how the eligible entity will target underage students in the
State;
(iii) a description of how the eligible entity intends to ensure that the statewide
coalition is actually implementing the
purpose of this section and moving toward
indicators described in subparagraph (D);
(iv) a list of the members of the statewide coalition or interested parties involved in the work of the eligible entity;
(v) a description of how the eligible entity intends to work with State agencies
on substance abuse prevention and education;
(vi) the anticipated impact of funds provided under this paragraph in preventing
and reducing the rates of underage alcohol
use;
(vii) outreach strategies, including ways
in which the eligible entity proposes to—
(I) reach out to students and community stakeholders;
(II) promote the purpose of this paragraph;
(III) address the range of needs of the
students and the surrounding communities; and
(IV) address community norms for underage students regarding alcohol use;
and
(viii) such additional information as required by the Secretary.
(C) Uses of funds
Each eligible entity that receives a grant
under this paragraph shall use the grant
funds to carry out the activities described in
such entity’s application submitted pursuant to subparagraph (B).
(D) Accountability
On the date on which the Secretary first
publishes a notice in the Federal Register
soliciting applications for grants under this
paragraph, the Secretary shall include in the
notice achievement indicators for the program authorized under this paragraph. The
achievement indicators shall be designed—
(i) to measure the impact that the statewide coalitions assisted under this paragraph are having on the institutions of
higher education and the surrounding communities, including changes in the number
of incidents of any kind in which students
have abused alcohol or consumed alcohol
while under the age of 21 (including violations, physical assaults, sexual assaults,
reports of intimidation, disruptions of
school functions, disruptions of student
studies, mental health referrals, illnesses,
or deaths);
(ii) to measure the quality and accessibility of the programs or information offered by the eligible entity; and
(iii) to provide such other measures of
program impact as the Secretary determines appropriate.
(E) Supplement not supplant
Grant funds provided under this paragraph
shall be used to supplement, and not sup-

§ 290bb–25b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

plant, Federal and non-Federal funds available for carrying out the activities described
in this paragraph.
(F) Definitions
For purposes of this paragraph:
(i) Eligible entity
The term ‘‘eligible entity’’ means a
State, institution of higher education, or
nonprofit entity.
(ii) Institution of higher education
The term ‘‘institution of higher education’’ has the meaning given the term in
section 1001(a) of title 20.
(iii) Secretary
The term ‘‘Secretary’’ means the Secretary of Education.
(iv) State
The term ‘‘State’’ means each of the 50
States, the District of Columbia, and the
Commonwealth of Puerto Rico.
(v) Statewide coalition
The term ‘‘statewide coalition’’ means a
coalition that—
(I) includes, but is not limited to—
(aa) institutions of higher education
within a State; and
(bb) a nonprofit group, a community
underage drinking prevention coalition, or another substance abuse prevention group within a State; and
(II) works toward lowering the alcohol
abuse rate by targeting underage students at institutions of higher education
throughout the State and in the surrounding communities.
(vi) Surrounding community
The term ‘‘surrounding community’’
means the community—
(I) that surrounds an institution of
higher education participating in a
statewide coalition;
(II) where the students from the institution of higher education take part in
the community; and
(III) where students from the institution of higher education live in off-campus housing.
(G) Administrative expenses
Not more than 5 percent of a grant under
this paragraph may be expended for administrative expenses.
(H) Authorization of appropriations
There are authorized to be appropriated to
carry out this paragraph $5,000,000 for fiscal
year 2007, and $5,000,000 for each of the fiscal
years 2008 through 2010.
(f) Additional research
(1) Additional research on underage drinking
(A) In general
The Secretary shall, subject to the availability of appropriations, collect data, and
conduct or support research that is not duplicative of research currently being con-

Page 684

ducted or supported by the Department of
Health and Human Services, on underage
drinking, with respect to the following:
(i) Comprehensive community-based programs or strategies and statewide systems
to prevent and reduce underage drinking,
across the underage years from early
childhood to age 21, including programs
funded and implemented by government
entities, public health interest groups and
foundations, and alcohol beverage companies and trade associations.
(ii) Annually obtain and report more precise information than is currently collected on the scope of the underage drinking problem and patterns of underage alcohol consumption, including improved
knowledge about the problem and progress
in preventing, reducing and treating underage drinking; as well as information on
the rate of exposure of youth to advertising and other media messages encouraging
and discouraging alcohol consumption.
(iii) Compiling information on the involvement of alcohol in unnatural deaths
of persons ages 12 to 20 in the United
States, including suicides, homicides, and
unintentional injuries such as falls,
drownings, burns, poisonings, and motor
vehicle crash deaths.
(B) Certain matters
The Secretary shall carry out activities
toward the following objectives with respect
to underage drinking:
(i) Obtaining new epidemiological data
within the national or targeted surveys
that identify alcohol use and attitudes
about alcohol use during pre- and early
adolescence, including harm caused to self
or others as a result of adolescent alcohol
use such as violence, date rape, risky sexual behavior, and prenatal alcohol exposure.
(ii) Developing or identifying successful
clinical treatments for youth with alcohol
problems.
(C) Peer review
Research under subparagraph (A) shall
meet current Federal standards for scientific
peer review.
(2) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection $6,000,000 for fiscal
year 2007, and $6,000,000 for each of the fiscal
years 2008 through 2010.
(July 1, 1944, ch. 373, title V, § 519B, as added
Pub. L. 106–310, div. B, title XXXI, § 3109, Oct. 17,
2000, 114 Stat. 1182; amended Pub. L. 109–422, § 2,
Dec. 20, 2006, 120 Stat. 2890.)
REFERENCES IN TEXT
The Drug-Free Communities Act of 1997, referred to
in subsec. (e)(1)(G), is Pub. L. 105–20, June 27, 1997, 111
Stat. 224, which is classified principally to subchapter
II (§ 1521 et seq.) of chapter 20 of Title 21, Food and
Drugs. For complete classification of this Act to the
Code, see Short Title of 1997 Amendment note set out
under section 1501 of Title 21 and Tables.
AMENDMENTS
2006—Pub. L. 109–422 added subsecs. (a) to (f) and
struck out former subsecs. (a) to (f), which related, re-

Page 685

TITLE 42—THE PUBLIC HEALTH AND WELFARE

spectively, to the Secretary’s authority to make
grants, cooperative agreements, or contracts for programs to prevent underage drinking; eligibility requirements; evaluation; geographical distribution; duration of award; and authorization of appropriations.

§ 290bb–25c. Services for individuals with fetal
alcohol syndrome
(a) In general
The Secretary shall make awards of grants,
cooperative agreements, or contracts to public
and nonprofit private entities, including Indian
tribes and tribal organizations, to provide services to individuals diagnosed with fetal alcohol
syndrome or alcohol-related birth defects.
(b) Use of funds
An award under subsection (a) of this section
may, subject to subsection (d) of this section, be
used to—
(1) screen and test individuals to determine
the type and level of services needed;
(2) develop a comprehensive plan for providing services to the individual;
(3) provide mental health counseling;
(4) provide substance abuse prevention services and treatment, if needed;
(5) coordinate services with other social programs including social services, justice system, educational services, health services,
mental health and substance abuse services,
financial assistance programs, vocational
services and housing assistance programs;
(6) provide vocational services;
(7) provide health counseling;
(8) provide housing assistance;
(9) parenting 1 skills training;
(10) overall 1 case management;
(11) supportive 1 services for families of individuals with Fetal Alcohol Syndrome; and
(12) provide other services and programs, to
the extent authorized by the Secretary after
consideration of recommendations made by
the National Task Force on Fetal Alcohol
Syndrome.
(c) Requirements
To be eligible to receive an award under subsection (a) of this section, an applicant shall—
(1) demonstrate that the program will be
part of a coordinated, comprehensive system
of care for such individuals;
(2) demonstrate an established communication with other social programs in the community including social services, justice system,
financial assistance programs, health services,
educational services, mental health and substance abuse services, vocational services and
housing assistance services;
(3) show a history of working with individuals with fetal alcohol syndrome or alcohol-related birth defects;
(4) provide assurance that the services will
be provided in a culturally and linguistically
appropriate manner; and
(5) provide assurance that at the end of the
5-year award period, other mechanisms will be
identified to meet the needs of the individuals
and families served under such award.
1 So

in original. Probably should be preceded by ‘‘provide’’.

§ 290bb–25d

(d) Relationship to payments under other programs
An award may be made under subsection (a) of
this section only if the applicant involved agrees
that the award will not be expended to pay the
expenses of providing any service under this section to an individual to the extent that payment
has been made, or can reasonably be expected to
be made, with respect to such expenses—
(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services
on a prepaid basis.
(e) Duration of awards
With respect to an award under subsection (a)
of this section, the period during which payments under such award are made to the recipient may not exceed 5 years.
(f) Evaluation
The Secretary shall evaluate each project carried out under subsection (a) of this section and
shall disseminate the findings with respect to
each such evaluation to appropriate public and
private entities.
(g) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$25,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal
years 2002 and 2003.
(2) Allocation
Of the amounts appropriated under paragraph (1) for a fiscal year, not less than
$300,000 shall, for purposes relating to fetal alcohol syndrome and alcohol-related birth defects, be made available for collaborative,
coordinated interagency efforts with the National Institute on Alcohol Abuse and Alcoholism, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, the Centers for Disease
Control and Prevention, the Department of
Education, and the Department of Justice.
(July 1, 1944, ch. 373, title V, § 519C, as added
Pub. L. 106–310, div. B, title XXXI, § 3110, Oct. 17,
2000, 114 Stat. 1183; amended Pub. L. 110–154,
§ 1(b)(9), Dec. 21, 2007, 121 Stat. 1827.)
AMENDMENTS
2007—Subsec. (g)(2). Pub. L. 110–154, which directed
substitution of ‘‘Eunice Kennedy Shriver National Institute of Child Health and Human Development’’ for
‘‘National Institute of Child Health and Human Development’’, was executed by making the substitution for
‘‘National Institute on Child Health and Human Development’’ to reflect the probable intent of Congress.

§ 290bb–25d. Centers of excellence on services for
individuals with fetal alcohol syndrome and
alcohol-related birth defects and treatment
for individuals with such conditions and
their families
(a) In general
The Secretary shall make awards of grants,
cooperative agreements, or contracts to public

§ 290bb–25e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or nonprofit private entities for the purposes of
establishing not more than four centers of excellence to study techniques for the prevention of
fetal alcohol syndrome and alcohol-related birth
defects and adaptations of innovative clinical
interventions and service delivery improvements for the provision of comprehensive services to individuals with fetal alcohol syndrome
or alcohol-related birth defects and their families and for providing training on such conditions.
(b) Use of funds
An award under subsection (a) of this section
may be used to—
(1) study adaptations of innovative clinical
interventions and service delivery improvements strategies for children and adults with
fetal alcohol syndrome or alcohol-related
birth defects and their families;
(2) identify communities which have an exemplary comprehensive system of care for
such individuals so that they can provide technical assistance to other communities attempting to set up such a system of care;
(3) provide technical assistance to communities who do not have a comprehensive system of care for such individuals and their families;
(4) train community leaders, mental health
and substance abuse professionals, families,
law enforcement personnel, judges, health professionals, persons working in financial assistance programs, social service personnel, child
welfare professionals, and other service providers on the implications of fetal alcohol syndrome and alcohol-related birth defects, the
early identification of and referral for such
conditions;
(5) develop innovative techniques for preventing alcohol use by women in child bearing
years;
(6) perform other functions, to the extent authorized by the Secretary after consideration
of recommendations made by the National
Task Force on Fetal Alcohol Syndrome.
(c) Report
(1) In general
A recipient of an award under subsection (a)
of this section shall at the end of the period of
funding report to the Secretary on any innovative techniques that have been discovered for
preventing alcohol use among women of child
bearing years.
(2) Dissemination of findings
The Secretary shall upon receiving a report
under paragraph (1) disseminate the findings
to appropriate public and private entities.
(d) Duration of awards
With respect to an award under subsection (a)
of this section, the period during which payments under such award are made to the recipient may not exceed 5 years.
(e) Evaluation
The Secretary shall evaluate each project carried out under subsection (a) of this section and
shall disseminate the findings with respect to
each such evaluation to appropriate public and
private entities.

Page 686

(f) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $5,000,000
for fiscal year 2001, and such sums as may be
necessary for each of the fiscal years 2002 and
2003.
(July 1, 1944, ch. 373, title V, § 519D, as added
Pub. L. 106–310, div. B, title XXXI, § 3110, Oct. 17,
2000, 114 Stat. 1185.)
§ 290bb–25e. Prevention of methamphetamine
and inhalant abuse and addiction
(a) Grants
The Director of the Center for Substance
Abuse Prevention (referred to in this section as
the ‘‘Director’’) may make grants to and enter
into contracts and cooperative agreements with
public and nonprofit private entities to enable
such entities—
(1) to carry out school-based programs concerning the dangers of methamphetamine or
inhalant abuse and addiction, using methods
that are effective and evidence-based, including initiatives that give students the responsibility to create their own anti-drug abuse
education programs for their schools; and
(2) to carry out community-based methamphetamine or inhalant abuse and addiction
prevention programs that are effective and
evidence-based.
(b) Use of funds
Amounts made available under a grant, contract or cooperative agreement under subsection
(a) of this section shall be used for planning, establishing, or administering methamphetamine
or inhalant prevention programs in accordance
with subsection (c) of this section.
(c) Prevention programs and activities
(1) In general
Amounts provided under this section may be
used—
(A) to carry out school-based programs
that are focused on those districts with high
or increasing rates of methamphetamine or
inhalant abuse and addiction and targeted at
populations which are most at risk to start
methamphetamine or inhalant abuse;
(B) to carry out community-based prevention programs that are focused on those populations within the community that are
most at-risk for methamphetamine or inhalant abuse and addiction;
(C) to assist local government entities to
conduct appropriate methamphetamine or
inhalant prevention activities;
(D) to train and educate State and local
law enforcement officials, prevention and
education officials, members of community
anti-drug coalitions and parents on the signs
of methamphetamine or inhalant abuse and
addiction and the options for treatment and
prevention;
(E) for planning, administration, and educational activities related to the prevention
of methamphetamine or inhalant abuse and
addiction;
(F) for the monitoring and evaluation of
methamphetamine or inhalant prevention

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

activities, and reporting and disseminating
resulting information to the public; and
(G) for targeted pilot programs with evaluation components to encourage innovation
and experimentation with new methodologies.
(2) Priority
The Director shall give priority in making
grants under this section to rural and urban
areas that are experiencing a high rate or
rapid increases in methamphetamine or inhalant abuse and addiction.
(d) Analyses and evaluation
(1) In general
Up to $500,000 of the amount available in
each fiscal year to carry out this section shall
be made available to the Director, acting in
consultation with other Federal agencies, to
support and conduct periodic analyses and
evaluations of effective prevention programs
for methamphetamine or inhalant abuse and
addiction and the development of appropriate
strategies for disseminating information
about and implementing these programs.
(2) Annual reports
The Director shall submit to the Committee
on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate and the Committee on Commerce and
Committee on Appropriations of the House of
Representatives, an annual report with the results of the analyses and evaluation under
paragraph (1).
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out subsection (a) of this section,
$10,000,000 for fiscal year 2001, and such sums as
may be necessary for each of fiscal years 2002
and 2003.
(July 1, 1944, ch. 373, title V, § 519E, as added
Pub. L. 106–310, div. B, title XXXI, § 3104(c), Oct.
17, 2000, 114 Stat. 1173.)
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 290bb–25f. Prevention and education programs
(a) In general
The Secretary of Health and Human Services
(referred to in this Act as the ‘‘Secretary’’) shall
award grants to public and nonprofit private entities to enable such entities to carry out
science-based education programs in elementary
and secondary schools to highlight the harmful
effects of anabolic steroids.
(b) Eligibility
(1) Application
To be eligible for grants under subsection (a)
of this section, an entity shall prepare and
submit to the Secretary an application at such
time, in such manner, and containing such information as the Secretary may require.

§ 290bb–31

(2) Preference
In awarding grants under subsection (a) of
this section, the Secretary shall give preference to applicants that intend to use grant
funds to carry out programs based on—
(A) the Athletes Training and Learning to
Avoid Steroids program;
(B) The Athletes Targeting Healthy Exercise and Nutrition Alternatives program;
and
(C) other programs determined to be effective by the National Institute on Drug
Abuse.
(c) Use of funds
Amounts received under a grant under subsection (a) of this section shall be used for education programs that will directly communicate
with teachers, principals, coaches, as well as elementary and secondary school children concerning the harmful effects of anabolic steroids.
(d) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $15,000,000 for each of fiscal years 2005 through 2010.
(Pub. L. 108–358, § 4, Oct. 22, 2004, 118 Stat. 1664.)
REFERENCES IN TEXT
This Act, referred to in subsec. (a), means Pub. L.
108–358, October 22, 2004, 92 Stat. 1661, known as the Anabolic Steroid Control Act of 2004. For complete classification of this Act to the Code, see Short Title of 2004
Amendment note set out under section 801 of Title 21,
Food and Drugs, and Tables.
CODIFICATION
Section was enacted as part of the Anabolic Steroid
Control Act of 2004, and not as part of the Public
Health Service Act which comprises this chapter.
SUBPART 3—CENTER FOR MENTAL HEALTH
SERVICES

§ 290bb–31. Center for Mental Health Services
(a) Establishment
There is established in the Administration a
Center for Mental Health Services (hereafter in
this section referred to as the ‘‘Center’’). The
Center shall be headed by a Director (hereafter
in this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive experience or academic
qualifications in the provision of mental health
services or in the evaluation of mental health
service systems.
(b) Duties
The Director of the Center shall—
(1) design national goals and establish national priorities for—
(A) the prevention of mental illness; and
(B) the promotion of mental health;
(2) encourage and assist local entities and
State agencies to achieve the goals and priorities described in paragraph (1);
(3) collaborate with the Department of Education and the Department of Justice to develop programs to assist local communities in
addressing violence among children and adolescents;

§ 290bb–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) develop and coordinate Federal prevention policies and programs and to assure increased focus on the prevention of mental illness and the promotion of mental health;
(5) develop improved methods of treating individuals with mental health problems and improved methods of assisting the families of
such individuals;
(6) administer the mental health services
block grant program authorized in section
300x of this title;
(7) promote policies and programs at Federal, State, and local levels and in the private
sector that foster independence and protect
the legal rights of persons with mental illness,
including carrying out the provisions of the
Protection and Advocacy of Mentally Ill Individuals Act 1 [42 U.S.C. 10801 et seq.];
(8) carry out the programs under part C of
this subchapter; and
(9) carry out responsibilities for the Human
Resource Development programs;
(10) conduct services-related assessments, including evaluations of the organization and financing of care, self-help and consumer-run
programs, mental health economics, mental
health service systems, rural mental health,
and improve the capacity of State to conduct
evaluations of publicly funded mental health
programs;
(11) establish a clearinghouse for mental
health information to assure the widespread
dissemination of such information to States,
political subdivisions, educational agencies
and institutions, treatment and prevention
service providers, and the general public, including information concerning the practical
application of research supported by the National Institute of Mental Health that is applicable to improving the delivery of services;
(12) provide technical assistance to public
and private entities that are providers of mental health services;
(13) monitor and enforce obligations incurred by community mental health centers
pursuant to the Community Mental Health
Centers Act (as in effect prior to the repeal of
such Act on August 13, 1981, by section
902(e)(2)(B) of Public Law 97–35 (95 Stat. 560));
(14) conduct surveys with respect to mental
health, such as the National Reporting Program; and
(15) assist States in improving their mental
health data collection.
(c) Grants and contracts
In carrying out the duties established in subsection (b) of this section, the Director may
make grants to and enter into contracts and cooperative agreements with public and nonprofit
private entities.
(July 1, 1944, ch. 373, title V, § 520, as added Pub.
L. 102–321, title I, § 115(a), July 10, 1992, 106 Stat.
346; amended Pub. L. 106–310, div. B, title XXXI,
§ 3112(c), Oct. 17, 2000, 114 Stat. 1188.)
REFERENCES IN TEXT
The Protection and Advocacy of Mentally Ill Individuals Act, referred to in subsec. (b)(7), probably means
1 See

References in Text note below.

Page 688

the Protection and Advocacy for Mentally Ill Individuals Act of 1986, which was Pub. L. 99–319, May 23, 1986,
100 Stat. 478, as amended. Pub. L. 99–319 was renamed
the Protection and Advocacy for Individuals with Mental Illness Act by Pub. L. 106–310, div. B, title XXXII,
§ 3206(a), Oct. 17, 2000, 114 Stat. 1193, and is classified
generally to chapter 114 (§ 10801 et seq.) of this title. For
complete classification of this Act to the Code, see
Short Title note set out under section 10801 of this title
and Tables.
The Community Mental Health Centers Act, referred
to in subsec. (b)(13), is title II of Pub. L. 88–164, as added
by Pub. L. 94–63, title III, § 303, July 29, 1975, 89 Stat.
309, and amended, which was classified principally to
subchapter III (§ 2689 et seq.) of chapter 33 of this title
prior to its repeal by Pub. L. 97–35, title IX,
§ 902(e)(2)(B), Aug. 13, 1981, 95 Stat. 560.
PRIOR PROVISIONS
A prior section 520 of act July 1, 1944, which was classified to section 290cc–13 of this title, was renumbered
section 520A of act July 1, 1944, by Pub. L. 102–321 and
transferred to section 290bb–32 of this title.
Another prior section 520 of act July 1, 1944, was renumbered section 519 by Pub. L. 101–93 and classified to
section 290cc–12 of this title, prior to repeal by Pub. L.
102–321, § 117.
AMENDMENTS
2000—Subsec. (b)(3) to (7). Pub. L. 106–310, § 3112(c)(1),
(2), added par. (3) and redesignated former pars. (3) to
(6) as (4) to (7), respectively. Former par. (7) redesignated (8).
Subsec. (b)(8). Pub. L. 106–310, § 3112(c)(1), (3), redesignated par. (7) as (8) and substituted ‘‘programs under
part C of this subchapter’’ for ‘‘programs authorized
under sections 290bb–32 and 290cc–21 of this title, including the Community Support Program and the Child
and Adolescent Service System Programs’’. Former
par. (8) redesignated (9).
Subsec. (b)(9). Pub. L. 106–310, § 3112(c)(4), which directed the amendment of par. (9) by substituting ‘‘programs’’ for ‘‘program and programs of clinical training
for professional and paraprofessional personnel pursuant to section 242a of this title’’ was executed by making the substitution for the phrase which began with
the words ‘‘program, and programs’’, to reflect the
probable intent of Congress.
Pub. L. 106–310, § 3112(c)(1), redesignated par. (8) as (9).
Former par. (9) redesignated (10).
Subsec. (b)(10) to (15). Pub. L. 106–310, § 3112(c)(1), redesignated pars. (9) to (14) as (10) to (15), respectively.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
MENTAL HEALTH SERVICES FOR INDIVIDUALS IN
CORRECTIONAL FACILITIES
Section 703 of Pub. L. 102–321 directed Secretary of
Health and Human Services, acting through Director of
Center for Mental Health Services, not later than July
10, 1992, to prepare and submit to Congress a report concerning most effective methods for providing mental
health services to individuals who come into contact
with the criminal justice system, including those individuals incarcerated in correctional facilities (including local jails and detention facilities), and the obstacles to providing such services, with such study to be
carried out in consultation with the National Institute
of Mental Health, the Department of Justice, and other
appropriate public and private entities.
EXECUTIVE ORDER NO. 13263
Ex. Ord. No. 13263, Apr. 29, 2002, 67 F.R. 22337, which
established President’s New Freedom Commission on
Mental Health, was revoked by Ex. Ord. No. 13316, § 3(g),
Sept. 17, 2003, 68 F.R. 55256, eff. Sept. 30, 2003.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 290bb–32. Priority mental health needs of regional and national significance
(a) Projects
The Secretary shall address priority mental
health needs of regional and national significance (as determined under subsection (b) of this
section) through the provision of or through assistance for—
(1) knowledge development and application
projects for prevention, treatment, and rehabilitation, and the conduct or support of evaluations of such projects;
(2) training and technical assistance programs;
(3) targeted capacity response programs; and
(4) systems change grants including statewide family network grants and client-oriented and consumer run self-help activities.
The Secretary may carry out the activities described in this subsection directly or through
grants or cooperative agreements with States,
political subdivisions of States, Indian tribes
and tribal organizations, other public or private
nonprofit entities.
(b) Priority mental health needs
(1) Determination of needs
Priority mental health needs of regional and
national significance shall be determined by
the Secretary in consultation with States and
other interested groups. The Secretary shall
meet with the States and interested groups on
an annual basis to discuss program priorities.
(2) Special consideration
In developing program priorities described in
paragraph (1), the Secretary shall give special
consideration to promoting the integration of
mental health services into primary health
care systems.
(c) Requirements
(1) In general
Recipients of grants, contracts, and cooperative agreements under this section shall comply with information and application requirements determined appropriate by the Secretary.
(2) Duration of award
With respect to a grant, contract, or cooperative agreement awarded under this section,
the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds
The Secretary may, for projects carried out
under subsection (a) of this section, require
that entities that apply for grants, contracts,
or cooperative agreements under this section
provide non-Federal matching funds, as determined appropriate by the Secretary, to ensure
the institutional commitment of the entity to
the projects funded under the grant, contract,
or cooperative agreement. Such non-Federal
matching funds may be provided directly or
through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment, or services.
(4) Maintenance of effort
With respect to activities for which a grant,
contract or cooperative agreement is awarded

§ 290bb–32

under this section, the Secretary may require
that recipients for specific projects under subsection (a) of this section agree to maintain
expenditures of non-Federal amounts for such
activities at a level that is not less than the
level of such expenditures maintained by the
entity for the fiscal year preceding the fiscal
year for which the entity receives such a
grant, contract, or cooperative agreement.
(d) Evaluation
The Secretary shall evaluate each project carried out under subsection (a)(1) of this section
and shall disseminate the findings with respect
to each such evaluation to appropriate public
and private entities.
(e) Information and education
(1) In general
The Secretary shall establish information
and education programs to disseminate and
apply the findings of the knowledge development and application, training, and technical
assistance programs, and targeted capacity response programs, under this section to the
general public, to health care professionals,
and to interested groups. The Secretary shall
make every effort to provide linkages between
the findings of supported projects and State
agencies responsible for carrying out mental
health services.
(2) Rural and underserved areas
In disseminating information on evidencebased practices in the provision of children’s
mental health services under this subsection,
the Secretary shall ensure that such information is distributed to rural and medically underserved areas.
(f) Authorization of appropriation
(1) In general
There are authorized to be appropriated to
carry out this section, $300,000,000 for fiscal
year 2001, and such sums as may be necessary
for each of the fiscal years 2002 and 2003.
(2) Data infrastructure
If amounts are not appropriated for a fiscal
year to carry out section 300y of this title with
respect to mental health, then the Secretary
shall make available, from the amounts appropriated for such fiscal year under paragraph
(1), an amount equal to the sum of $6,000,000
and 10 percent of all amounts appropriated for
such fiscal year under such paragraph in excess of $100,000,000, to carry out such section
300y of this title.
(July 1, 1944, ch. 373, title V, § 520A, as added
Pub. L. 100–690, title II, § 2057(3), Nov. 18, 1988, 102
Stat. 4212; renumbered § 520 and amended Pub. L.
101–93, § 3(e), (g), Aug. 16, 1989, 103 Stat. 610, 611;
Pub. L. 101–639, § 2, Nov. 28, 1990, 104 Stat. 4600;
renumbered § 520A and amended Pub. L. 102–321,
title I, § 116, July 10, 1992, 106 Stat. 348; Pub. L.
106–310, div. B, title XXXII, § 3201(a), Oct. 17, 2000,
114 Stat. 1189.)
CODIFICATION
Section was formerly classified to section 290cc–13 of
this title prior to renumbering by Pub. L. 102–321.

§ 290bb–33

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2000—Pub. L. 106–310 amended section catchline and
text generally, substituting provisions relating to priority mental health needs of regional and national significance for provisions relating to establishment of
grant programs for demonstration projects.
1992—Subsec. (a)(1). Pub. L. 102–321, § 116(b)(1), substituted ‘‘Center for Mental Health Services’’ for ‘‘National Institute of Mental Health’’.
Subsec. (c). Pub. L. 102–321, § 116(b)(2), substituted
‘‘five’’ for ‘‘three’’.
Subsec. (e)(1). Pub. L. 102–321, § 116(b)(3), amended par.
(1) generally. Prior to amendment, par. (1) read as follows: ‘‘For the purposes of carrying out this section,
there are authorized to be appropriated $40,000,000 for
fiscal year 1991, and such sums as may be necessary for
each of the fiscal years 1992 and 1993.’’
1990—Subsec. (a). Pub. L. 101–639, § 2(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) read
as follows: ‘‘The Secretary, acting through the Director, may make grants to States, political subdivisions
of States, and nonprofit private agencies—
‘‘(1) for mental health services demonstration
projects for the planning, coordination, and improvement of community services (including outreach and
self-help services) for seriously mentally ill individuals, seriously emotionally disturbed children and
youth, elderly individuals, and homeless seriously
mentally ill individuals, and for the conduct of research concerning such services;
‘‘(2) for demonstration projects for the prevention
of youth suicide;
‘‘(3) for demonstration projects for the improvement of the recognition, assessment, treatment, and
clinical management of depressive disorders; and
‘‘(4) for demonstration projects for treatment and
prevention relating to sex offenses.’’
Subsec. (e)(1). Pub. L. 101–639, § 2(b), amended par. (1)
generally. Prior to amendment, par. (1) read as follows:
‘‘For the purposes of carrying out this section, there
are authorized to be appropriated $60,000,000 for each of
the fiscal years 1989 and 1990.’’
1989—Pub. L. 101–93 substituted ‘‘programs’’ for ‘‘program’’ in section catchline and in subsec. (a) substituted ‘‘seriously mentally ill’’ for ‘‘chronically mentally ill’’ wherever appearing, redesignated par. (5) as
(4), and inserted ‘‘for’’ before ‘‘demonstration’’ in pars.
(2), (3), and (4).
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
COMMUNITY MENTAL HEALTH SERVICES DEMONSTRATION
PROJECTS FOR HOMELESS INDIVIDUALS WHO ARE
CHRONICALLY MENTALLY ILL
Pub. L. 100–77, title VI, § 612, July 22, 1987, 101 Stat.
523, as amended by Pub. L. 100–607, title VIII, § 821, Nov.
4, 1988, 102 Stat. 3171; Pub. L. 100–628, title VI, § 621, Nov.
7, 1988, 102 Stat. 3244; Pub. L. 101–93, § 5(t)(1), (2), Aug. 16,
1989, 103 Stat. 615; Pub. L. 101–645, title V, § 521, Nov. 29,
1990, 104 Stat. 4734, which authorized to be appropriated
for payments under this section such sums as may be
necessary for each of the fiscal years 1991 through 1993,
in addition to any other amounts authorized to be appropriated for such payments for each of such fiscal
years with such additional amounts to be available
only for the provision of community-based mental
health services to homeless individuals who are chronically mentally ill, and amounts paid to grantees under
subsection (a) of this section that remain unobligated
at the end of the fiscal year in which the amounts were
received to remain available to grantees during the
succeeding fiscal year for the purposes for which the
payments were made, was repealed by Pub. L. 106–310,
div. B, title XXXII, § 3201(b)(3), Oct. 17, 2000, 114 Stat.
1190.

Page 690

§ 290bb–33. National centers of excellence for depression
(a) Depressive disorder defined
In this section, the term ‘‘depressive disorder’’
means a mental or brain disorder relating to depression, including major depression, bipolar
disorder, and related mood disorders.
(b) Grant program
(1) In general
The Secretary, acting through the Administrator, shall award grants on a competitive
basis to eligible entities to establish national
centers of excellence for depression (referred
to in this section as ‘‘Centers’’), which shall
engage in activities related to the treatment
of depressive disorders.
(2) Allocation of awards
If the funds authorized under subsection (f)
are appropriated in the amounts provided for
under such subsection, the Secretary shall allocate such amounts so that—
(A) not later than 1 year after March 23,
2010, not more than 20 Centers may be established; and
(B) not later than September 30, 2016, not
more than 30 Centers may be established.
(3) Grant period
(A) In general
A grant awarded under this section shall
be for a period of 5 years.
(B) Renewal
A grant awarded under subparagraph (A)
may be renewed, on a competitive basis, for
1 additional 5-year period, at the discretion
of the Secretary. In determining whether to
renew a grant, the Secretary shall consider
the report cards issued under subsection
(e)(2).
(4) Use of funds
Grant funds awarded under this subsection
shall be used for the establishment and ongoing activities of the recipient of such funds.
(5) Eligible entities
(A) Requirements
To be eligible to receive a grant under this
section, an entity shall—
(i) be an institution of higher education
or a public or private nonprofit research
institution; and
(ii) submit an application to the Secretary at such time and in such manner as
the Secretary may require, as described in
subparagraph (B).
(B) Application
An application described in subparagraph
(A)(ii) shall include—
(i) evidence that such entity—
(I) provides, or is capable of coordinating with other entities to provide,
comprehensive health services with a
focus on mental health services and subspecialty expertise for depressive disorders;
(II) collaborates with other mental
health providers, as necessary, to address co-occurring mental illnesses;

Page 691

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(III) is capable of training health professionals about mental health; and
(ii) such other information, as the Secretary may require.
(C) Priorities
In awarding grants under this section, the
Secretary shall give priority to eligible entities that meet 1 or more of the following criteria:
(i) Demonstrated capacity and expertise
to serve the targeted population.
(ii) Existing infrastructure or expertise
to provide appropriate, evidence-based and
culturally and linguistically competent
services.
(iii) A location in a geographic area with
disproportionate numbers of underserved
and at-risk populations in medically underserved areas and health professional
shortage areas.
(iv) Proposed innovative approaches for
outreach to initiate or expand services.
(v) Use of the most up-to-date science,
practices, and interventions available.
(vi) Demonstrated capacity to establish
cooperative and collaborative agreements
with community mental health centers
and other community entities to provide
mental health, social, and human services
to individuals with depressive disorders.
(6) National coordinating center
(A) In general
The Secretary, acting through the Administrator, shall designate 1 recipient of a
grant under this section to be the coordinating center of excellence for depression
(referred to in this section as the ‘‘coordinating center’’). The Secretary shall select
such coordinating center on a competitive
basis, based upon the demonstrated capacity
of such center to perform the duties described in subparagraph (C).
(B) Application
A Center that has been awarded a grant
under paragraph (1) may apply for designation as the coordinating center by submitting an application to the Secretary at such
time, in such manner, and containing such
information as the Secretary may require.
(C) Duties
The coordinating center shall—
(i) develop, administer, and coordinate
the network of Centers under this section;
(ii) oversee and coordinate the national
database described in subsection (d);
(iii) lead a strategy to disseminate the
findings and activities of the Centers
through such database; and
(iv) serve as a liaison with the Administration, the National Registry of Evidence-based Programs and Practices of the
Administration, and any Federal interagency or interagency forum on mental
health.
(7) Matching funds
The Secretary may not award a grant or
contract under this section to an entity unless

§ 290bb–33

the entity agrees that it will make available
(directly or through contributions from other
public or private entities) non-Federal contributions toward the activities to be carried
out under the grant or contract in an amount
equal to $1 for each $5 of Federal funds provided under the grant or contract. Such nonFederal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind,
fairly evaluated, including plant, equipment,
or services.
(c) Activities of the Centers
Each Center shall carry out the following activities:
(1) General activities
Each Center shall—
(A) integrate basic, clinical, or health
services interdisciplinary research and practice in the development, implementation,
and dissemination of evidence-based interventions;
(B) involve a broad cross-section of stakeholders, such as researchers, clinicians, consumers, families of consumers, and voluntary health organizations, to develop a research agenda and disseminate findings, and
to provide support in the implementation of
evidence-based practices;
(C) provide training and technical assistance to mental health professionals, and engage in and disseminate translational research with a focus on meeting the needs of
individuals with depressive disorders; and
(D) educate policy makers, employers,
community leaders, and the public about depressive disorders to reduce stigma and raise
awareness of treatments.
(2) Improved treatment standards, clinical
guidelines, diagnostic protocols, and care
coordination practice
Each Center shall collaborate with other
Centers in the network to—
(A) develop and implement treatment
standards, clinical guidelines, and protocols
that emphasize primary prevention, early
intervention, treatment for, and recovery
from, depressive disorders;
(B) foster communication with other providers attending to co-occurring physical
health conditions such as cardiovascular, diabetes, cancer, and substance abuse disorders;
(C) leverage available community resources, develop and implement improved
self-management programs, and, when appropriate, involve family and other providers of social support in the development and
implementation of care plans; and
(D) use electronic health records and telehealth technology to better coordinate and
manage, and improve access to, care, as determined by the coordinating center.
(3) Translational research through collaboration of centers and community-based organizations
Each Center shall—
(A) demonstrate effective use of a publicprivate partnership to foster collaborations

§ 290bb–34

TITLE 42—THE PUBLIC HEALTH AND WELFARE

among members of the network and community-based organizations such as community
mental health centers and other social and
human services providers;
(B) expand interdisciplinary, translational,
and patient-oriented research and treatment; and
(C) coordinate with accredited academic
programs to provide ongoing opportunities
for the professional and continuing education of mental health providers.
(d) National database
(1) In general
The coordinating center shall establish and
maintain a national, publicly available database to improve prevention programs, evidence-based interventions, and disease management programs for depressive disorders,
using data collected from the Centers, as described in paragraph (2).
(2) Data collection
Each Center shall submit data gathered at
such center, as appropriate, to the coordinating center regarding—
(A) the prevalence and incidence of depressive disorders;
(B) the health and social outcomes of individuals with depressive disorders;
(C) the effectiveness of interventions designed, tested, and evaluated;
(D) other information, as the Secretary
may require.
(3) Submission of data to the Administrator
The coordinating center shall submit to the
Administrator the data and financial information gathered under paragraph (2).
(4) Publication using data from the database
A Center, or an individual affiliated with a
Center, may publish findings using the data
described in paragraph (2) only if such center
submits such data to the coordinating center,
as required under such paragraph.
(e) Establishment of standards; report cards and
recommendations; third party review
(1) Establishment of standards
The Secretary, acting through the Administrator, shall establish performance standards
for—
(A) each Center; and
(B) the network of Centers as a whole.
(2) Report cards
The Secretary, acting through the Administrator, shall—
(A) for each Center, not later than 3 years
after the date on which such center of excellence is established and annually thereafter,
issue a report card to the coordinating center to rate the performance of such Center;
and
(B) not later than 3 years after the date on
which the first grant is awarded under subsection (b)(1) and annually thereafter, issue
a report card to Congress to rate the performance of the network of centers of excellence as a whole.
(3) Recommendations
Based upon the report cards described in
paragraph (2), the Secretary shall, not later
than September 30, 2015—

Page 692

(A) make recommendations to the Centers
regarding improvements such centers shall
make; and
(B) make recommendations to Congress for
expanding the Centers to serve individuals
with other types of mental disorders.
(4) Third party review
Not later than 3 years after the date on
which the first grant is awarded under subsection (b)(1) and annually thereafter, the Secretary shall arrange for an independent third
party to conduct an evaluation of the network
of Centers to ensure that such centers are
meeting the goals of this section.
(f) Authorization of appropriations
(1) In general
To carry out this section, there are authorized to be appropriated—
(A) $100,000,000 for each of the fiscal years
2011 through 2015; and
(B) $150,000,000 for each of the fiscal years
2016 through 2020.
(2) Allocation of funds authorized
Of the amount appropriated under paragraph
(1) for a fiscal year, the Secretary shall determine the allocation of each Center receiving a
grant under this section, but in no case may
the allocation be more than $5,000,000, except
that the Secretary may allocate not more
than $10,000,000 to the coordinating center.
(July 1, 1944, ch. 373, title V, § 520B, as added
Pub. L. 111–148, title X, § 10410(b), Mar. 23, 2010,
124 Stat. 984.)
PRIOR PROVISIONS
A prior section 290bb–33, act July 1, 1944, ch. 373, title
V, § 520B, formerly title XXIV, § 2441, as added Pub. L.
100–607, title II, § 211, Nov. 4, 1988, 102 Stat. 3092; renumbered title V, § 520B, and amended Pub. L. 102–321, title
I, § 118(a), (b)(2), July 10, 1992, 106 Stat. 348, 349, related
to demonstration projects for individuals with positive
test results, prior to repeal by Pub. L. 106–310, div. B,
title XXXII, § 3201(b)(2), Oct. 17, 2000, 114 Stat. 1190.

§ 290bb–34. Youth interagency research, training,
and technical assistance centers
(a) Program authorized
The Secretary, acting through the Administrator of the Substance Abuse and Mental
Health Services Administration, and in consultation with the Administrator of the Office of
Juvenile Justice and Delinquency Prevention,
the Director of the Bureau of Justice Assistance
and the Director of the National Institutes of
Health—
(1) shall award grants or contracts to public
or nonprofit private entities to establish not
more than four research, training, and technical assistance centers to carry out the activities described in subsection (c) of this section; and
(2) shall award a competitive grant to 1 additional research, training, and technical assistance center to carry out the activities described in subsection (d) of this section.
(b) Application
A public or private nonprofit entity desiring a
grant or contract under subsection (a) of this

Page 693

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section shall prepare and submit an application
to the Secretary at such time, in such manner,
and containing such information as the Secretary may require.
(c) Authorized activities
A center established under a grant or contract
under subsection (a)(1) of this section shall—
(1) provide training with respect to state-ofthe-art mental health and justice-related services and successful mental health and substance abuse-justice collaborations that focus
on children and adolescents, to public policymakers, law enforcement administrators, public defenders, police, probation officers,
judges, parole officials, jail administrators and
mental health and substance abuse providers
and administrators;
(2) engage in research and evaluations concerning State and local justice and mental
health systems, including system redesign initiatives, and disseminate information concerning the results of such evaluations;
(3) provide direct technical assistance, including assistance provided through toll-free
telephone numbers, concerning issues such as
how to accommodate individuals who are
being processed through the courts under the
Americans with Disabilities Act of 1990 (42
U.S.C. 12101 et seq.), what types of mental
health or substance abuse service approaches
are effective within the judicial system, and
how community-based mental health or substance abuse services can be more effective,
including relevant regional, ethnic, and gender-related considerations; and
(4) provide information, training, and technical assistance to State and local governmental officials to enhance the capacity of
such officials to provide appropriate services
relating to mental health or substance abuse.
(d) Additional center
The additional research, training, and technical assistance center established under subsection (a)(2) of this section shall provide appropriate information, training, and technical assistance to States, political subdivisions of a
State, Federally recognized Indian tribes, tribal
organizations, institutions of higher education,
public organizations, or private nonprofit organizations for—
(1) the development or continuation of statewide or tribal youth suicide early intervention
and prevention strategies;
(2) ensuring the surveillance of youth suicide
early intervention and prevention strategies;
(3) studying the costs and effectiveness of
statewide youth suicide early intervention and
prevention strategies in order to provide information concerning relevant issues of importance to State, tribal, and national policymakers;
(4) further identifying and understanding
causes and associated risk factors for youth
suicide;
(5) analyzing the efficacy of new and existing
youth suicide early intervention techniques
and technology;
(6) ensuring the surveillance of suicidal behaviors and nonfatal suicidal attempts;
(7) studying the effectiveness of State-sponsored statewide and tribal youth suicide early

§ 290bb–35

intervention and prevention strategies on the
overall wellness and health promotion strategies related to suicide attempts;
(8) promoting the sharing of data regarding
youth suicide with Federal agencies involved
with youth suicide early intervention and prevention, and State-sponsored statewide or
tribal youth suicide early intervention and
prevention strategies for the purpose of identifying previously unknown mental health
causes and associated risk factors for suicide
in youth;
(9) evaluating and disseminating outcomes
and best practices of mental and behavioral
health services at institutions of higher education; and
(10) other activities determined appropriate
by the Secretary.
(e) Authorization of appropriations
(1) For the purpose of awarding grants or contracts under subsection (a)(1) of this section,
there is authorized to be appropriated $4,000,000
for fiscal year 2001, and such sums as may be
necessary for fiscal years 2002 and 2003.
(2) For the purpose of awarding a grant under
subsection (a)(2) of this section, there are authorized to be appropriated $3,000,000 for fiscal
year 2005, $4,000,000 for fiscal year 2006, and
$5,000,000 for fiscal year 2007.
(July 1, 1944, ch. 373, title V, § 520C, as added
Pub. L. 106–310, div. B, title XXXI, § 3104(b), Oct.
17, 2000, 114 Stat. 1173; amended Pub. L. 108–355,
§ 3(a), Oct. 21, 2004, 118 Stat. 1405.)
REFERENCES IN TEXT
The Americans with Disabilities Act of 1990, referred
to in subsec. (c)(3), is Pub. L. 101–336, July 26, 1990, 104
Stat. 327, as amended, which is classified principally to
chapter 126 (§ 12101 et seq.) of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 12101 of this title and Tables.
AMENDMENTS
2004—Subsec. (a). Pub. L. 108–355, § 3(a)(1), substituted
dash for comma after ‘‘National Institutes of Health’’,
designated remainder of existing provisions as par. (1),
substituted ‘‘; and’’ for period, and added par. (2).
Subsec. (c). Pub. L. 108–355, § 3(a)(2), substituted
‘‘(a)(1)’’ for ‘‘(a)’’ in introductory provisions.
Subsec. (d). Pub. L. 108–355, § 3(a)(5), added subsec. (d).
Former subsec. (d) redesignated (e).
Pub. L. 108–355, § 3(a)(3), designated existing provisions as par. (1), substituted ‘‘awarding grants or contracts under subsection (a)(1) of this section’’ for ‘‘carrying out this section’’, and added par. (2).
Subsec. (e). Pub. L. 108–355, § 3(a)(4), redesignated subsec. (d) as (e).

§ 290bb–35. Services for youth offenders
(a) In general
The Secretary, acting through the Director of
the Center for Mental Health Services, and in
consultation with the Director of the Center for
Substance Abuse Treatment, the Administrator
of the Office of Juvenile Justice and Delinquency Prevention, and the Director of the Special Education Programs, shall award grants on
a competitive basis to State or local juvenile
justice agencies to enable such agencies to provide aftercare services for youth offenders who
have been discharged from facilities in the juve-

§ 290bb–36

TITLE 42—THE PUBLIC HEALTH AND WELFARE

nile or criminal justice system and have serious
emotional disturbances or are at risk of developing such disturbances.
(b) Use of funds
A State or local juvenile justice agency receiving a grant under subsection (a) of this section shall use the amounts provided under the
grant—
(1) to develop a plan describing the manner
in which the agency will provide services for
each youth offender who has a serious emotional disturbance and has been detained or
incarcerated in facilities within the juvenile
or criminal justice system;
(2) to provide a network of core or aftercare
services or access to such services for each
youth offender, including diagnostic and evaluation services, substance abuse treatment
services, outpatient mental health care services, medication management services, intensive home-based therapy, intensive day treatment services, respite care, and therapeutic
foster care;
(3) to establish a program that coordinates
with other State and local agencies providing
recreational, social, educational, vocational,
or operational services for youth, to enable
the agency receiving a grant under this section to provide community-based system of
care services for each youth offender that addresses the special needs of the youth and
helps the youth access all of the aforementioned services; and
(4) using not more than 20 percent of funds
received, to provide planning and transition
services as described in paragraph (3) for
youth offenders while such youth are incarcerated or detained.
(c) Application
A State or local juvenile justice agency that
desires a grant under subsection (a) of this section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary
may reasonably require.
(d) Report
Not later than 3 years after October 17, 2000,
and annually thereafter, the Secretary shall prepare and submit, to the Committee on Health,
Education, Labor, and Pensions of the Senate
and the Committee on Commerce of the House
of Representatives, a report that describes the
services provided pursuant to this section.
(e) Definitions
In this section:
(1) Serious emotional disturbance
The term ‘‘serious emotional disturbance’’
with respect to a youth offender means an offender who currently, or at any time within
the 1-year period ending on the day on which
services are sought under this section, has a
diagnosable mental, behavioral, or emotional
disorder that functionally impairs the offender’s life by substantially limiting the offender’s role in family, school, or community activities, and interfering with the offender’s
ability to achieve or maintain one or more developmentally-appropriate social, behavior,
cognitive, communicative, or adaptive skills.

Page 694

(2) Community-based system of care
The term ‘‘community-based system of
care’’ means the provision of services for the
youth offender by various State or local agencies that in an interagency fashion or operating as a network addresses the recreational,
social, educational, vocational, mental health,
substance abuse, and operational needs of the
youth offender.
(3) Youth offender
The term ‘‘youth offender’’ means an individual who is 21 years of age or younger who
has been discharged from a State or local juvenile or criminal justice system, except that if
the individual is between the ages of 18 and 21
years, such individual has had contact with
the State or local juvenile or criminal justice
system prior to attaining 18 years of age and
is under the jurisdiction of such a system at
the time services are sought.
(f) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $40,000,000 for fiscal year
2001, and such sums as may be necessary for
each of fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 520D, as added
Pub. L. 106–310, div. B, title XXXI, § 3107, Oct. 17,
2000, 114 Stat. 1179.)
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 290bb–36. Youth suicide early intervention and
prevention strategies
(a) In general
The Secretary, acting through the Administrator of the Substance Abuse and Mental
Health Services Administration, shall award
grants or cooperative agreements to eligible entities to—
(1) develop and implement State-sponsored
statewide or tribal youth suicide early intervention and prevention strategies in schools,
educational institutions, juvenile justice systems, substance abuse programs, mental
health programs, foster care systems, and
other child and youth support organizations;
(2) support public organizations and private
nonprofit organizations actively involved in
State-sponsored statewide or tribal youth suicide early intervention and prevention strategies and in the development and continuation
of State-sponsored statewide youth suicide
early intervention and prevention strategies;
(3) provide grants to institutions of higher
education to coordinate the implementation of
State-sponsored statewide or tribal youth suicide early intervention and prevention strategies;
(4) collect and analyze data on State-sponsored statewide or tribal youth suicide early
intervention and prevention services that can
be used to monitor the effectiveness of such

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

services and for research, technical assistance,
and policy development; and
(5) assist eligible entities, through Statesponsored statewide or tribal youth suicide
early intervention and prevention strategies,
in achieving targets for youth suicide reductions under title V of the Social Security Act
[42 U.S.C. 701 et seq.].
(b) Eligible entity
(1) Definition
In this section, the term ‘‘eligible entity’’
means—
(A) a State;
(B) a public organization or private nonprofit organization designated by a State to
develop or direct the State-sponsored statewide youth suicide early intervention and
prevention strategy; or
(C) a Federally recognized Indian tribe or
tribal organization (as defined in the Indian
Self-Determination and Education Assistance Act [25 U.S.C. 450 et seq.]) or an urban
Indian organization (as defined in the Indian
Health Care Improvement Act [25 U.S.C. 1601
et seq.]) that is actively involved in the development and continuation of a tribal
youth suicide early intervention and prevention strategy.
(2) Limitation
In carrying out this section, the Secretary
shall ensure that each State is awarded only 1
grant or cooperative agreement under this section. For purposes of the preceding sentence, a
State shall be considered to have been awarded a grant or cooperative agreement if the eligible entity involved is the State or an entity
designated by the State under paragraph
(1)(B). Nothing in this paragraph shall be construed to apply to entities described in paragraph (1)(C).
(c) Preference
In providing assistance under a grant or cooperative agreement under this section, an eligible
entity shall give preference to public organizations, private nonprofit organizations, political
subdivisions, institutions of higher education,
and tribal organizations actively involved with
the State-sponsored statewide or tribal youth
suicide early intervention and prevention strategy that—
(1) provide early intervention and assessment services, including screening programs,
to youth who are at risk for mental or emotional disorders that may lead to a suicide attempt, and that are integrated with school
systems, educational institutions, juvenile
justice systems, substance abuse programs,
mental health programs, foster care systems,
and other child and youth support organizations;
(2) demonstrate collaboration among early
intervention and prevention services or certify
that entities will engage in future collaboration;
(3) employ or include in their applications a
commitment to evaluate youth suicide early
intervention and prevention practices and
strategies adapted to the local community;
(4) provide timely referrals for appropriate
community-based mental health care and

§ 290bb–36

treatment of youth who are at risk for suicide
in child-serving settings and agencies;
(5) provide immediate support and information resources to families of youth who are at
risk for suicide;
(6) offer access to services and care to youth
with diverse linguistic and cultural backgrounds;
(7) offer appropriate postsuicide intervention
services, care, and information to families,
friends, schools, educational institutions, juvenile justice systems, substance abuse programs, mental health programs, foster care
systems, and other child and youth support organizations of youth who recently completed
suicide;
(8) offer continuous and up-to-date information and awareness campaigns that target parents, family members, child care professionals,
community care providers, and the general
public and highlight the risk factors associated with youth suicide and the life-saving
help and care available from early intervention and prevention services;
(9) ensure that information and awareness
campaigns on youth suicide risk factors, and
early intervention and prevention services,
use effective communication mechanisms that
are targeted to and reach youth, families,
schools, educational institutions, and youth
organizations;
(10) provide a timely response system to ensure that child-serving professionals and providers are properly trained in youth suicide
early intervention and prevention strategies
and that child-serving professionals and providers involved in early intervention and prevention services are properly trained in effectively identifying youth who are at risk for
suicide;
(11) provide continuous training activities
for child care professionals and community
care providers on the latest youth suicide
early intervention and prevention services
practices and strategies;
(12) conduct annual self-evaluations of outcomes and activities, including consulting
with interested families and advocacy organizations;
(13) provide services in areas or regions with
rates of youth suicide that exceed the national
average as determined by the Centers for Disease Control and Prevention; and
(14) obtain informed written consent from a
parent or legal guardian of an at-risk child before involving the child in a youth suicide
early intervention and prevention program.
(d) Requirement for direct services
Not less than 85 percent of grant funds received under this section shall be used to provide direct services, of which not less than 5 percent shall be used for activities authorized
under subsection (a)(3) of this section.
(e) Coordination and collaboration
(1) In general
In carrying out this section, the Secretary
shall collaborate with relevant Federal agencies and suicide working groups responsible
for early intervention and prevention services
relating to youth suicide.

§ 290bb–36

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Consultation
In carrying out this section, the Secretary
shall consult with—
(A) State and local agencies, including
agencies responsible for early intervention
and prevention services under title XIX of
the Social Security Act [42 U.S.C. 1396 et
seq.], the State Children’s Health Insurance
Program under title XXI of the Social Security Act [42 U.S.C. 1397aa et seq.], and programs funded by grants under title V of the
Social Security Act [42 U.S.C. 701 et seq.];
(B) local and national organizations that
serve youth at risk for suicide and their
families;
(C) relevant national medical and other
health and education specialty organizations;
(D) youth who are at risk for suicide, who
have survived suicide attempts, or who are
currently receiving care from early intervention services;
(E) families and friends of youth who are
at risk for suicide, who have survived suicide
attempts, who are currently receiving care
from early intervention and prevention services, or who have completed suicide;
(F) qualified professionals who possess the
specialized knowledge, skills, experience,
and relevant attributes needed to serve
youth at risk for suicide and their families;
and
(G) third-party payers, managed care organizations, and related commercial industries.
(3) Policy development
In carrying out this section, the Secretary
shall—
(A) coordinate and collaborate on policy
development at the Federal level with the
relevant Department of Health and Human
Services agencies and suicide working
groups; and
(B) consult on policy development at the
Federal level with the private sector, including consumer, medical, suicide prevention
advocacy groups, and other health and education
professional-based
organizations,
with respect to State-sponsored statewide or
tribal youth suicide early intervention and
prevention strategies.
(f) Rule of construction; religious and moral accommodation
Nothing in this section shall be construed to
require suicide assessment, early intervention,
or treatment services for youth whose parents
or legal guardians object based on the parents’
or legal guardians’ religious beliefs or moral objections.
(g) Evaluations and report
(1) Evaluations by eligible entities
Not later than 18 months after receiving a
grant or cooperative agreement under this section, an eligible entity shall submit to the
Secretary the results of an evaluation to be
conducted by the entity concerning the effectiveness of the activities carried out under the
grant or agreement.

Page 696

(2) Report
Not later than 2 years after October 21, 2004,
the Secretary shall submit to the appropriate
committees of Congress a report concerning
the results of—
(A) the evaluations conducted under paragraph (1); and
(B) an evaluation conducted by the Secretary to analyze the effectiveness and efficacy of the activities conducted with grants,
collaborations, and consultations under this
section.
(h) Rule of construction; student medication
Nothing in this section or section 290bb–36a of
this title shall be construed to allow school personnel to require that a student obtain any
medication as a condition of attending school or
receiving services.
(i) Prohibition
Funds appropriated to carry out this section,
section 290bb–34 of this title, section 290bb–36a of
this title, or section 290bb–36b of this title shall
not be used to pay for or refer for abortion.
(j) Parental consent
States and entities receiving funding under
this section and section 290bb–36a of this title
shall obtain prior written, informed consent
from the child’s parent or legal guardian for assessment services, school-sponsored programs,
and treatment involving medication related to
youth suicide conducted in elementary and secondary schools. The requirement of the preceding sentence does not apply in the following
cases:
(1) In an emergency, where it is necessary to
protect the immediate health and safety of the
student or other students.
(2) Other instances, as defined by the State,
where parental consent cannot reasonably be
obtained.
(k) Relation to education provisions
Nothing in this section or section 290bb–36a of
this title shall be construed to supersede section
1232g of title 20, including the requirement of
prior parental consent for the disclosure of any
education records. Nothing in this section or
section 290bb–36a of this title shall be construed
to modify or affect parental notification requirements for programs authorized under the
Elementary and Secondary Education Act of
1965 [20 U.S.C. 6301 et seq.] (as amended by the
No Child Left Behind Act of 2001; Public Law
107–110).
(l) Definitions
In this section:
(1) Early intervention
The term ‘‘early intervention’’ means a
strategy or approach that is intended to prevent an outcome or to alter the course of an
existing condition.
(2) Educational institution; institution of higher education; school
The term—
(A) ‘‘educational institution’’ means a
school or institution of higher education;
(B) ‘‘institution of higher education’’ has
the meaning given such term in section 1001
of title 20; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) ‘‘school’’ means an elementary or secondary school (as such terms are defined in
section 9101 of the Elementary and Secondary Education Act of 1965 [20 U.S.C. 7801]).
(3) Prevention
The term ‘‘prevention’’ means a strategy or
approach that reduces the likelihood or risk of
onset, or delays the onset, of adverse health
problems that have been known to lead to suicide.
(4) Youth
The term ‘‘youth’’ means individuals who
are between 10 and 24 years of age.
(m) Authorization of appropriations
(1) In general
For the purpose of carrying out this section,
there are authorized to be appropriated
$7,000,000 for fiscal year 2005, $18,000,000 for fiscal year 2006, and $30,000,000 for fiscal year
2007.
(2) Preference
If less than $3,500,000 is appropriated for any
fiscal year to carry out this section, in awarding grants and cooperative agreements under
this section during the fiscal year, the Secretary shall give preference to States that
have rates of suicide that significantly exceed
the national average as determined by the
Centers for Disease Control and Prevention.
(July 1, 1944, ch. 373, title V, § 520E, as added
Pub. L. 108–355, § 3(c), Oct. 21, 2004, 118 Stat. 1409.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (a)(5)
and (e)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles V, XIX, and XXI of the Act are classified generally to subchapters V (§ 701 et seq.), XIX
(§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively,
of chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (b)(1)(C), is Pub. L.
93–638, Jan. 4, 1975, 88 Stat. 2203, as amended, which is
classified principally to subchapter II (§ 450 et seq.) of
chapter 14 of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set
out under section 450 of Title 25 and Tables.
The Indian Health Care Improvement Act, referred to
in subsec. (b)(1)(C), is Pub. L. 94–437, Sept. 30, 1976, 90
Stat. 1400, as amended, which is classified principally
to chapter 18 (§ 1601 et seq.) of Title 25, Indians. For
complete classification of this Act to the Code, see
Short Title note set out under section 1601 of Title 25
and Tables.
The Elementary and Secondary Education Act of
1965, referred to in subsec. (k), is Pub. L. 89–10, Apr. 11,
1965, 79 Stat. 27, as amended, which is classified generally to chapter 70 (§ 6301 et seq.) of Title 20, Education.
For complete classification of this Act to the Code, see
Short Title note set out under section 6301 of Title 20
and Tables.
The No Child Left Behind Act of 2001, referred to in
subsec. (k), is Pub. L. 107–110, Jan. 8, 2002, 115 Stat. 1425.
For complete classification of this Act to the Code, see
Short Title of 2002 Amendment note set out under section 6301 of Title 20, Education, and Tables.
PRIOR PROVISIONS
A prior section 290bb–36, act July 1, 1944, ch. 373, title
V, § 520E, as added Pub. L. 106–310, div. B, title XXXI,
§ 3111, Oct. 17, 2000, 114 Stat. 1186, and amended, which

§ 290bb–36

related to suicide prevention for children and adolescents, was renumbered section 520E–1 of act July 1,
1944, by Pub. L. 108–355, § 3(b)(2), Oct. 21, 2004, 118 Stat.
1409, and transferred to section 290bb–36a of this title.
CONGRESSIONAL FINDINGS
Pub. L. 108–355, § 2, Oct. 21, 2004, 118 Stat. 1404, provided that: ‘‘Congress makes the following findings:
‘‘(1) More children and young adults die from suicide each year than from cancer, heart disease, AIDS,
birth defects, stroke, and chronic lung disease combined.
‘‘(2) Over 4,000 children and young adults tragically
take their lives every year, making suicide the third
overall cause of death between the ages of 10 and 24.
According to the Centers for Disease Control and Prevention, suicide is the third overall cause of death
among college-age students.
‘‘(3) According to the National Center for Injury
Prevention and Control of the Centers for Disease
Control and Prevention, children and young adults
accounted for 15 percent of all suicides completed in
2000.
‘‘(4) From 1952 to 1995, the rate of suicide in children and young adults tripled.
‘‘(5) From 1980 to 1997, the rate of suicide among
young adults ages 15 to 19 increased 11 percent.
‘‘(6) From 1980 to 1997, the rate of suicide among
children ages 10 to 14 increased 109 percent.
‘‘(7) According to the National Center of Health
Statistics, suicide rates among Native Americans
range from 1.5 to 3 times the national average for
other groups, with young people ages 15 to 34 making
up 64 percent of all suicides.
‘‘(8) Congress has recognized that youth suicide is a
public health tragedy linked to underlying mental
health problems and that youth suicide early intervention and prevention activities are national priorities.
‘‘(9) Youth suicide early intervention and prevention have been listed as urgent public health priorities by the President’s New Freedom Commission in
[probably should be ‘‘on’’] Mental Health (2002), the
Institute of Medicine’s Reducing Suicide: A National
Imperative (2002), the National Strategy for Suicide
Prevention: Goals and Objectives for Action (2001),
and the Surgeon General’s Call to Action To Prevent
Suicide (1999).
‘‘(10) Many States have already developed comprehensive statewide youth suicide early intervention
and prevention strategies that seek to provide effective early intervention and prevention services.
‘‘(11) In a recent report, a startling 85 percent of
college counseling centers revealed an increase in the
number of students they see with psychological problems. Furthermore, the American College Health Association found that 61 percent of college students reported feeling hopeless, 45 percent said they felt so
depressed they could barely function, and 9 percent
felt suicidal.
‘‘(12) There is clear evidence of an increased incidence of depression among college students. According to a survey described in the Chronicle of Higher
Education (February 1, 2002), depression among freshmen has nearly doubled (from 8.2 percent to 16.3 percent). Without treatment, researchers recently noted
that ‘depressed adolescents are at risk for school failure, social isolation, promiscuity, self-medication
with drugs and alcohol, and suicide—now the third
leading cause of death among 10–24 year olds.’.
‘‘(13) Researchers who conducted the study
‘Changes in Counseling Center Client Problems
Across 13 Years’ (1989–2001) at Kansas State University stated that ‘students are experiencing more
stress, more anxiety, more depression than they were
a decade ago.’ (The Chronicle of Higher Education,
February 14, 2003).
‘‘(14) According to the 2001 National Household Survey on Drug Abuse, 20 percent of full-time undergraduate college students use illicit drugs.

§ 290bb–36a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(15) The 2001 National Household Survey on Drug
Abuse also reported that 18.4 percent of adults aged 18
to 24 are dependent on or abusing illicit drugs or alcohol. In addition, the study found that ‘serious mental
illness is highly correlated with substance dependence or abuse. Among adults with serious mental illness in 2001, 20.3 percent were dependent on or abused
alcohol or illicit drugs, while the rate among adults
without serious mental illness was only 6.3 percent.’.
‘‘(16) A 2003 Gallagher’s Survey of Counseling Center Directors found that 81 percent were concerned
about the increasing number of students with more
serious psychological problems, 67 percent reported a
need for more psychiatric services, and 63 percent reported problems with growing demand for services
without an appropriate increase in resources.
‘‘(17) The International Association of Counseling
Services accreditation standards recommend 1 counselor per 1,000 to 1,500 students. According to the 2003
Gallagher’s Survey of Counseling Center Directors,
the ratio of counselors to students is as high as 1
counselor per 2,400 students at institutions of higher
education with more than 15,000 students.’’

§ 290bb–36a. Suicide prevention for youth
(a) In general
The Secretary shall award grants or cooperative agreements to public organizations, private
nonprofit organizations, political subdivisions,
consortia of political subdivisions, consortia of
States, or Federally recognized Indian tribes or
tribal organizations to design early intervention
and prevention strategies that will complement
the State-sponsored statewide or tribal youth
suicide early intervention and prevention strategies developed pursuant to section 290bb–36 of
this title.
(b) Collaboration
In carrying out subsection (a) of this section,
the Secretary shall ensure that activities under
this section are coordinated with the relevant
Department of Health and Human Services
agencies and suicide working groups.
(c) Requirements
A public organization, private nonprofit organization, political subdivision, consortium of political subdivisions, consortium of States, or
federally recognized Indian tribe or tribal organization desiring a grant, contract, or cooperative agreement under this section shall demonstrate that the suicide prevention program
such entity proposes will—
(1)(A) comply with the State-sponsored
statewide early intervention and prevention
strategy as developed under section 290bb–36 of
this title; and
(B) in the case of a consortium of States, receive the support of all States involved;
(2) provide for the timely assessment, treatment, or referral for mental health or substance abuse services of youth at risk for suicide;
(3) be based on suicide prevention practices
and strategies that are adapted to the local
community;
(4) integrate its suicide prevention program
into the existing health care system in the
community including general, mental, and behavioral health services, and substance abuse
services;
(5) be integrated into other systems in the
community that address the needs of youth in-

Page 698

cluding the school systems, educational institutions, juvenile justice system, substance
abuse programs, mental health programs, foster care systems, and community child and
youth support organizations;
(6) use primary prevention methods to educate and raise awareness in the local community by disseminating evidence-based information about suicide prevention;
(7) include suicide prevention, mental
health, and related information and services
for the families and friends of those who completed suicide, as needed;
(8) offer access to services and care to youth
with diverse linguistic and cultural backgrounds;
(9) conduct annual self-evaluations of outcomes and activities, including consulting
with interested families and advocacy organizations; 1
(10) ensure that staff used in the program are
trained in suicide prevention and that professionals involved in the system of care have received training in identifying persons at risk
of suicide.
(d) Use of funds
Amounts provided under a grant or cooperative agreement under this section shall be used
to supplement, and not supplant, Federal and
non-Federal funds available for carrying out the
activities described in this section. Applicants
shall provide financial information to demonstrate compliance with this section.
(e) Condition
An applicant for a grant or cooperative agreement under subsection (a) of this section shall
demonstrate to the Secretary that the application complies with the State-sponsored statewide early intervention and prevention strategy
as developed under section 290bb–36 of this title
and the applicant has the support of the local
community and relevant public health officials.
(f) Special populations
In awarding grants and cooperative agreements under subsection (a) of this section, the
Secretary shall ensure that such awards are
made in a manner that will focus on the needs
of communities or groups that experience high
or rapidly rising rates of suicide.
(g) Application
A public organization, private nonprofit organization, political subdivision, consortium of political subdivisions, consortium of States, or
Federally recognized Indian tribe or tribal organization receiving a grant or cooperative agreement under subsection (a) of this section shall
prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may
reasonably require. Such application shall include a plan for the rigorous evaluation of activities funded under the grant or cooperative
agreement, including a process and outcome
evaluation.
(h) Distribution of awards
In awarding grants and cooperative agreements under subsection (a) of this section, the
1 So

in original. Probably should be followed by ‘‘and’’.

Page 699

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Secretary shall ensure that such awards are distributed among the geographical regions of the
United States and between urban and rural settings.
(i) Evaluation
A public organization, private nonprofit organization, political subdivision, consortium of political subdivisions, consortium of States, or
Federally recognized Indian tribe or tribal organization receiving a grant or cooperative agreement under subsection (a) of this section shall
prepare and submit to the Secretary at the end
of the program period, an evaluation of all activities funded under this section.
(j) Dissemination and education
The Secretary shall ensure that findings derived from activities carried out under this section are disseminated to State, county and local
governmental agencies and public and private
nonprofit organizations active in promoting suicide prevention and family support activities.
(k) Duration of projects
With respect to a grant, contract, or cooperative agreement awarded under this section, the
period during which payments under such award
may be made to the recipient may not exceed 3
years.
(l) Study
Within 1 year after October 17, 2000, the Secretary shall, directly or by grant or contract,
initiate a study to assemble and analyze data to
identify—
(1) unique profiles of children under 13 who
attempt or complete suicide;
(2) unique profiles of youths between ages 13
and 24 who attempt or complete suicide; and
(3) a profile of services available to these
groups and the use of these services by children and youths from paragraphs (1) and (2).
(m) Definitions
In this section, the terms ‘‘early intervention’’, ‘‘educational institution’’, ‘‘institution of
higher education’’, ‘‘prevention’’, ‘‘school’’, and
‘‘youth’’ have the meanings given to those terms
in section 290bb–36 of this title.
(n) Authorization of appropriation
For purposes of carrying out this section,
there is authorized to be appropriated $75,000,000
for fiscal year 2001 and such sums as may be necessary for each of the fiscal years 2002 through
2003.
(July 1, 1944, ch. 373, title V, § 520E–1, formerly
§ 520E, as added Pub. L. 106–310, div. B, title
XXXI, § 3111, Oct. 17, 2000, 114 Stat. 1186; renumbered § 520E–1 and amended Pub. L. 108–355, § 3(b),
Oct. 21, 2004, 118 Stat. 1407.)
CODIFICATION
Section was formerly classified to section 290bb–36 of
this title prior to renumbering by Pub. L. 108–355.
AMENDMENTS
2004—Pub. L. 108–355, § 3(b)(1)(A), substituted ‘‘youth’’
for ‘‘children and adolescents’’ in section catchline.
Subsec. (a). Pub. L. 108–355, § 3(b)(1)(B), added subsec.
(a) and struck out heading and text of former subsec.
(a). Text read as follows: ‘‘The Secretary shall award

§ 290bb–36a

grants, contracts, or cooperative agreements to States,
political subdivisions of States, Indian tribes, tribal organizations, public organizations, or private nonprofit
organizations to establish programs to reduce suicide
deaths in the United States among children and adolescents.’’
Subsec. (b). Pub. L. 108–355, § 3(b)(1)(C), substituted
‘‘with the relevant Department of Health and Human
Services agencies and suicide working groups.’’ for
‘‘among the Substance Abuse and Mental Health Services Administration, the relevant institutes at the National Institutes of Health, the Centers for Disease
Control and Prevention, the Health Resources and
Services Administration, and the Administration on
Children and Families.’’
Subsec. (c). Pub. L. 108–355, § 3(b)(1)(D)(i), substituted
‘‘A public organization, private nonprofit organization,
political subdivision, consortium of political subdivisions, consortium of States, or federally recognized Indian tribe or tribal organization desiring’’ for ‘‘A State,
political subdivision of a State, Indian tribe, tribal organization, public organization, or private nonprofit organization desiring’’ in introductory provisions.
Subsec. (c)(1). Pub. L. 108–355, § 3(b)(1)(D)(iii), added
par. (1). Former par. (1) redesignated (2).
Subsec. (c)(2). Pub. L. 108–355, § 3(b)(1)(D)(ii), (iv), redesignated par. (1) as (2) and substituted ‘‘youth’’ for
‘‘children and adolescents’’. Former par. (2) redesignated (3).
Subsec. (c)(3). Pub. L. 108–355, § 3(b)(1)(D)(ii), (v), redesignated par. (2) as (3) and struck out ‘‘best evidencebased,’’ after ‘‘based on’’. Former par. (3) redesignated
(4).
Subsec. (c)(4). Pub. L. 108–355, § 3(b)(1)(D)(ii), (vi), redesignated par. (3) as (4) and substituted ‘‘general, mental, and behavioral health services, and substance
abuse services;’’ for ‘‘primary health care, mental
health services, and substance abuse services;’’. Former
par. (4) redesignated (5).
Subsec. (c)(5). Pub. L. 108–355, § 3(b)(1)(D)(ii), (vii), redesignated par. (4) as (5) and substituted ‘‘youth including the school systems, educational institutions, juvenile justice system, substance abuse programs, mental
health programs, foster care systems, and community
child and youth support organizations;’’ for ‘‘children
and adolescents including the educational system, juvenile justice system, welfare and child protection systems, and community youth support organizations;’’.
Former par. (5) redesignated (6).
Subsec. (c)(6), (7). Pub. L. 108–355, § 3(b)(1)(D)(ii), redesignated pars. (5) and (6) as (6) and (7), respectively.
Former par. (7) redesignated (8).
Subsec. (c)(8). Pub. L. 108–355, § 3(b)(1)(D)(viii), added
par. (8) and struck out former par. (8) which read as follows: ‘‘provide linguistically appropriate and culturally
competent services, as needed;’’.
Pub. L. 108–355, § 3(b)(1)(D)(ii), redesignated par. (7) as
(8). Former par. (8) redesignated (9).
Subsec. (c)(9). Pub. L. 108–355, § 3(b)(1)(D)(ix), added
par. (9) and struck out former par. (9) which read as follows: ‘‘provide a plan for the evaluation of outcomes
and activities at the local level, according to standards
established by the Secretary, and agree to participate
in a national evaluation; and’’.
Pub. L. 108–355, § 3(b)(1)(D)(ii), redesignated par. (8) as
(9). Former par. (9) redesignated (10).
Subsec. (c)(10). Pub. L. 108–355, § 3(b)(1)(D)(ii), redesignated par. (9) as (10).
Subsec. (d). Pub. L. 108–355, § 3(b)(1)(E), added subsec.
(d) and struck out heading and text of former subsec.
(d). Text read as follows: ‘‘Amounts provided under
grants, contracts, or cooperative agreements under
subsection (a) of this section shall be used to supplement and not supplant other Federal, State, and local
public funds that are expended to provide services for
eligible individuals.’’
Subsec. (e). Pub. L. 108–355, § 3(b)(1)(F), struck out
‘‘, contract,’’ after ‘‘grant’’ and inserted ‘‘application
complies with the State-sponsored statewide early
intervention and prevention strategy as developed

§ 290bb–36b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

under section 290bb–36 of this title and the’’ after ‘‘Secretary that the’’.
Subsec. (f). Pub. L. 108–355, § 3(b)(1)(G), struck out
‘‘, contracts,’’ after ‘‘grants’’.
Subsec. (g). Pub. L. 108–355, § 3(b)(1)(H), substituted
‘‘A public organization, private nonprofit organization,
political subdivision, consortium of political subdivisions, consortium of States, or Federally recognized Indian tribe or tribal organization receiving’’ for ‘‘A
State, political subdivision of a State, Indian tribe,
tribal organization, public organization, or private nonprofit organization receiving’’ and struck out
‘‘, contract,’’ after ‘‘grant’’ in two places.
Subsec. (h). Pub. L. 108–355, § 3(b)(1)(I), struck out
‘‘, contracts,’’ after ‘‘grants’’.
Subsec. (i). Pub. L. 108–355, § 3(b)(1)(J), substituted ‘‘A
public organization, private nonprofit organization, political subdivision, consortium of political subdivisions,
consortium of States, or Federally recognized Indian
tribe or tribal organization receiving’’ for ‘‘A State, political subdivision of a State, Indian tribe, tribal organization, public organization, or private nonprofit organization receiving’’ and struck out ‘‘, contract,’’ after
‘‘grant’’.
Subsec. (k). Pub. L. 108–355, § 3(b)(1)(K), substituted ‘‘3
years’’ for ‘‘5 years’’.
Subsec. (l)(2). Pub. L. 108–355, § 3(b)(1)(L)(i), substituted ‘‘24’’ for ‘‘21’’.
Subsec. (l)(3). Pub. L. 108–355, § 3(b)(1)(L)(ii), struck
out ‘‘which might have been’’ after ‘‘profile of services’’.
Subsec. (m). Pub. L. 108–355, § 3(b)(1)(O), added subsec.
(m). Former subsec. (m) redesignated (n).
Pub. L. 108–355, § 3(b)(1)(M), struck out par. (1) designation and heading and struck out heading and text
of par. (2). Text read as follows: ‘‘In carrying out this
section, the Secretary shall use 1 percent of the
amount appropriated under paragraph (1) for each fiscal
year for managing programs under this section.’’
Subsec. (n). Pub. L. 108–355, § 3(b)(1)(N), redesignated
subsec. (m) as (n).
TEEN SUICIDE PREVENTION STUDY
Pub. L. 106–386, div. B, title VI, § 1602, Oct. 28, 2000, 114
Stat. 1538, provided that:
‘‘(a) SHORT TITLE.—This section may be cited as the
‘Teen Suicide Prevention Act of 2000’.
‘‘(b) FINDINGS.—Congress finds that—
‘‘(1) measures that increase public awareness of suicide as a preventable public health problem, and target parents and youth so that suicide risks and warning signs can be recognized, will help to eliminate the
ignorance and stigma of suicide as barriers to youth
and families seeking preventive care;
‘‘(2) suicide prevention efforts in the year 2000
should—
‘‘(A) target at-risk youth, particularly youth with
mental health problems, substance abuse problems,
or contact with the juvenile justice system;
‘‘(B) involve—
‘‘(i) the identification of the characteristics of
the at-risk youth and other youth who are contemplating suicide, and barriers to treatment of
the youth; and
‘‘(ii) the development of model treatment programs for the youth;
‘‘(C) include a pilot study of the outcomes of
treatment for juvenile delinquents with mental
health or substance abuse problems;
‘‘(D) include a public education approach to combat the negative effects of the stigma of, and discrimination against individuals with, mental
health and substance abuse problems; and
‘‘(E) include a nationwide effort to develop, implement, and evaluate a mental health awareness
program for schools, communities, and families;
‘‘(3) although numerous symptoms, diagnoses,
traits, characteristics, and psychosocial stressors of
suicide have been investigated, no single factor or set
of factors has ever come close to predicting suicide
with accuracy;

Page 700

‘‘(4) research of United States youth, such as a 1994
study by Lewinsohn, Rohde, and Seeley, has shown
predictors of suicide, such as a history of suicide attempts, current suicidal ideation and depression, a
recent attempt or completed suicide by a friend, and
low self-esteem; and
‘‘(5) epidemiological data illustrate—
‘‘(A) the trend of suicide at younger ages as well
as increases in suicidal ideation among youth in
the United States; and
‘‘(B) distinct differences in approaches to suicide
by gender, with—
‘‘(i) 3 to 5 times as many females as males attempting suicide; and
‘‘(ii) 3 to 5 times as many males as females completing suicide.
‘‘(c) PURPOSE.—The purpose of this section is to provide for a study of predictors of suicide among at-risk
and other youth, and barriers that prevent the youth
from receiving treatment, to facilitate the development of model treatment programs and public education and awareness efforts.
‘‘(d) STUDY.—Not later than 1 year after the date of
the enactment of this Act [Oct. 28, 2000], the Secretary
of Health and Human Services shall carry out, directly
or by grant or contract, a study that is designed to
identify—
‘‘(1) the characteristics of at-risk and other youth
age 13 through 21 who are contemplating suicide;
‘‘(2) the characteristics of at-risk and other youth
who are younger than age 13 and are contemplating
suicide; and
‘‘(3) the barriers that prevent youth described in
paragraphs (1) and (2) from receiving treatment.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
such sums as may be necessary.’’
[For definition of ‘‘youth’’ as used in section 1602 of
Pub. L. 106–386, set out above, see section 1002 of Pub.
L. 106–386, set out as a note under section 3796gg–2 of
this title.]

§ 290bb–36b. Mental and behavioral health services on campus
(a) In general
The Secretary, acting through the Director of
the Center for Mental Health Services, in consultation with the Secretary of Education, may
award grants on a competitive basis to institutions of higher education to enhance services for
students with mental and behavioral health
problems that can lead to school failure, such as
depression, substance abuse, and suicide attempts, so that students will successfully complete their studies.
(b) Use of funds
The Secretary may not make a grant to an institution of higher education under this section
unless the institution agrees to use the grant
only for—
(1) educational seminars;
(2) the operation of hot lines;
(3) preparation of informational material;
(4) preparation of educational materials for
families of students to increase awareness of
potential mental and behavioral health issues
of students enrolled at the institution of higher education;
(5) training programs for students and campus personnel to respond effectively to students with mental and behavioral health problems that can lead to school failure, such as
depression, substance abuse, and suicide attempts; or

Page 701

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) the creation of a networking infrastructure to link colleges and universities that do
not have mental health services with health
care providers who can treat mental and behavioral health problems.
(c) Eligible grant recipients
Any institution of higher education receiving
a grant under this section may carry out activities under the grant through—
(1) college counseling centers;
(2) college and university psychological service centers;
(3) mental health centers;
(4) psychology training clinics; or
(5) institution of higher education supported, evidence-based, mental health and substance abuse programs.
(d) Application
An institution of higher education desiring a
grant under this section shall prepare and submit an application to the Secretary at such time
and in such manner as the Secretary may require. At a minimum, the application shall include the following:
(1) A description of identified mental and behavioral health needs of students at the institution of higher education.
(2) A description of Federal, State, local, private, and institutional resources currently
available to address the needs described in
paragraph (1) at the institution of higher education.
(3) A description of the outreach strategies
of the institution of higher education for promoting access to services, including a proposed plan for reaching those students most in
need of mental health services.
(4) A plan to evaluate program outcomes, including a description of the proposed use of
funds, the program objectives, and how the objectives will be met.
(5) An assurance that the institution will
submit a report to the Secretary each fiscal
year on the activities carried out with the
grant and the results achieved through those
activities.
(e) Requirement of matching funds
(1) In general
The Secretary may make a grant under this
section to an institution of higher education
only if the institution agrees to make available (directly or through donations from public or private entities) non-Federal contributions in an amount that is not less than $1 for
each $1 of Federal funds provided in the grant,
toward the costs of activities carried out with
the grant (as described in subsection (b) of this
section) and other activities by the institution
to reduce student mental and behavioral
health problems.
(2) Determination of amount contributed
Non-Federal contributions required under
paragraph (1) may be in cash or in kind.
Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the
amount of such non-Federal contributions.

§ 290bb–37

(3) Waiver
The Secretary may waive the requirement
established in paragraph (1) with respect to an
institution of higher education if the Secretary determines that extraordinary need at
the institution justifies the waiver.
(f) Reports
For each fiscal year that grants are awarded
under this section, the Secretary shall conduct a
study on the results of the grants and submit to
the Congress a report on such results that includes the following:
(1) An evaluation of the grant program outcomes, including a summary of activities carried out with the grant and the results
achieved through those activities.
(2) Recommendations on how to improve access to mental and behavioral health services
at institutions of higher education, including
efforts to reduce the incidence of suicide and
substance abuse.
(g) Definition
In this section, the term ‘‘institution of higher
education’’ has the meaning given such term in
section 1001 of title 20.
(h) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $5,000,000
for fiscal year 2005, $5,000,000 for fiscal year 2006,
and $5,000,000 for fiscal year 2007.
(July 1, 1944, ch. 373, title V, § 520E–2, as added
Pub. L. 108–355, § 3(d), Oct. 21, 2004, 118 Stat.
1413.)
§ 290bb–37. Grants for emergency mental health
centers
(a) Program authorized
The Secretary shall award grants to States,
political subdivisions of States, Indian tribes,
and tribal organizations to support the designation of hospitals and health centers as Emergency Mental Health Centers.
(b) Health center
In this section, the term ‘‘health center’’ has
the meaning given such term in section 254b of
this title, and includes community health centers and community mental health centers.
(c) Distribution of awards
The Secretary shall ensure that such grants
awarded under subsection (a) of this section are
equitably distributed among the geographical
regions of the United States, between urban and
rural populations, and between different settings of care including health centers, mental
health centers, hospitals, and other psychiatric
units or facilities.
(d) Application
A State, political subdivision of a State, Indian tribe, or tribal organization that desires a
grant under subsection (a) of this section shall
submit an application to the Secretary at such
time, in such manner, and containing such information as the Secretary may require, including a plan for the rigorous evaluation of activities carried out with funds received under this
section.

§ 290bb–38

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Use of funds
(1) In general
A State, political subdivision of a State, Indian tribe, or tribal organization receiving a
grant under subsection (a) of this section shall
use funds from such grant to establish or designate hospitals and health centers as Emergency Mental Health Centers.
(2) Emergency mental health centers
Such emergency mental health centers described in paragraph (1)—
(A) shall—
(i) serve as a central receiving point in
the community for individuals who may be
in need of emergency mental health services;
(ii) purchase, if needed, any equipment
necessary to evaluate, diagnose and stabilize an individual with a mental illness;
(iii) provide training, if needed, to the
medical personnel staffing the Emergency
Mental Health Center to evaluate, diagnose, stabilize, and treat an individual
with a mental illness; and
(iv) provide any treatment that is necessary for an individual with a mental illness or a referral for such individual to another facility where such treatment may
be received; and
(B) may establish and train a mobile crisis
intervention team to respond to mental
health emergencies within the community.
(f) Evaluation
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a
grant under subsection (a) of this section shall
prepare and submit an evaluation to the Secretary at such time, in such manner, and containing such information as the Secretary may
reasonably require, including an evaluation of
activities carried out with funds received under
this section and a process and outcomes evaluation.
(g) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $25,000,000 for fiscal year
2001 and such sums as may be necessary for each
of the fiscal years 2002 through 2003.
(July 1, 1944, ch. 373, title V, § 520F, as added
Pub. L. 106–310, div. B, title XXXII, § 3209, Oct.
17, 2000, 114 Stat. 1200.)
§ 290bb–38. Grants for jail diversion programs
(a) Program authorized
The Secretary shall make up to 125 grants to
States, political subdivisions of States, Indian
tribes, and tribal organizations, acting directly
or through agreements with other public or nonprofit entities, to develop and implement programs to divert individuals with a mental illness from the criminal justice system to community-based services.
(b) Administration
(1) Consultation
The Secretary shall consult with the Attorney General and any other appropriate officials in carrying out this section.

Page 702

(2) Regulatory authority
The Secretary shall issue regulations and
guidelines necessary to carry out this section,
including methodologies and outcome measures for evaluating programs carried out by
States, political subdivisions of States, Indian
tribes, and tribal organizations receiving
grants under subsection (a) of this section.
(c) Applications
(1) In general
To receive a grant under subsection (a) of
this section, the chief executive of a State,
chief executive of a subdivision of a State, Indian tribe or tribal organization shall prepare
and submit an application to the Secretary at
such time, in such manner, and containing
such information as the Secretary shall reasonably require.
(2) Content
Such application shall—
(A) contain an assurance that—
(i) community-based mental health services will be available for the individuals
who are diverted from the criminal justice
system, and that such services are based
on the best known practices, reflect current research findings, include case management, assertive community treatment,
medication management and access, integrated mental health and co-occurring
substance abuse treatment, and psychiatric rehabilitation, and will be coordinated with social services, including life
skills training, housing placement, vocational training, education job placement,
and health care;
(ii) there has been relevant interagency
collaboration between the appropriate
criminal justice, mental health, and substance abuse systems; and
(iii) the Federal support provided will be
used to supplement, and not supplant,
State, local, Indian tribe, or tribal organization sources of funding that would otherwise be available;
(B) demonstrate that the diversion program will be integrated with an existing system of care for those with mental illness;
(C) explain the applicant’s inability to
fund the program adequately without Federal assistance;
(D) specify plans for obtaining necessary
support and continuing the proposed program following the conclusion of Federal
support; and
(E) describe methodology and outcome
measures that will be used in evaluating the
program.
(d) Use of funds
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a
grant under subsection (a) of this section may
use funds received under such grant to—
(1) integrate the diversion program into the
existing system of care;
(2) create or expand community-based mental health and co-occurring mental illness and
substance abuse services to accommodate the
diversion program;

Page 703

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) train professionals involved in the system
of care, and law enforcement officers, attorneys, and judges; and
(4) provide community outreach and crisis
intervention.
(e) Federal share
(1) In general
The Secretary shall pay to a State, political
subdivision of a State, Indian tribe, or tribal
organization receiving a grant under subsection (a) of this section the Federal share of
the cost of activities described in the application.
(2) Federal share
The Federal share of a grant made under
this section shall not exceed 75 percent of the
total cost of the program carried out by the
State, political subdivision of a State, Indian
tribe, or tribal organization. Such share shall
be used for new expenses of the program carried out by such State, political subdivision of
a State, Indian tribe, or tribal organization.
(3) Non-Federal share
The non-Federal share of payments made
under this section may be made in cash or in
kind fairly evaluated, including planned equipment or services. The Secretary may waive
the requirement of matching contributions.
(f) Geographic distribution
The Secretary shall ensure that such grants
awarded under subsection (a) of this section are
equitably distributed among the geographical
regions of the United States and between urban
and rural populations.
(g) Training and technical assistance
Training and technical assistance may be provided by the Secretary to assist a State, political subdivision of a State, Indian tribe, or tribal
organization receiving a grant under subsection
(a) of this section in establishing and operating
a diversion program.
(h) Evaluations
The programs described in subsection (a) of
this section shall be evaluated not less than one
time in every 12-month period using the methodology and outcome measures identified in the
grant application.
(i) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $10,000,000 for fiscal year
2001, and such sums as may be necessary for fiscal years 2002 through 2003.
(July 1, 1944, ch. 373, title V, § 520G, as added
Pub. L. 106–310, div. B, title XXXII, § 3210, Oct.
17, 2000, 114 Stat. 1201.)
§ 290bb–39. Improving outcomes for children and
adolescents through services integration between child welfare and mental health services
(a) In general
The Secretary shall award grants, contracts or
cooperative agreements to States, political subdivisions of States, Indian tribes, and tribal organizations to provide integrated child welfare

§ 290bb–39

and mental health services for children and adolescents under 19 years of age in the child welfare system or at risk for becoming part of the
system, and parents or caregivers with a mental
illness or a mental illness and a co-occurring
substance abuse disorder.
(b) Duration
With respect to a grant, contract or cooperative agreement awarded under this section, the
period during which payments under such award
are made to the recipient may not exceed 5
years.
(c) Application
(1) In general
To be eligible to receive an award under subsection (a) of this section, a State, political
subdivision of a State, Indian tribe, or tribal
organization shall submit an application to
the Secretary at such time, in such manner,
and accompanied by such information as the
Secretary may reasonably require.
(2) Content
An application submitted under paragraph
(1) shall—
(A) describe the program to be funded
under the grant, contract or cooperative
agreement;
(B) explain how such program reflects best
practices in the provision of child welfare
and mental health services; and
(C) provide assurances that—
(i) persons providing services under the
grant, contract or cooperative agreement
are adequately trained to provide such
services; and
(ii) the services will be provided in accordance with subsection (d) of this section.
(d) Use of funds
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a
grant, contract, or cooperative agreement under
subsection (a) of this section shall use amounts
made available through such grant, contract or
cooperative agreement to—
(1) provide family-centered, comprehensive,
and coordinated child welfare and mental
health services, including prevention, early
intervention and treatment services for children and adolescents, and for their parents or
caregivers;
(2) ensure a single point of access for such
coordinated services;
(3) provide integrated mental health and
substance abuse treatment for children, adolescents, and parents or caregivers with a
mental illness and a co-occurring substance
abuse disorder;
(4) provide training for the child welfare,
mental health and substance abuse professionals who will participate in the program
carried out under this section;
(5) provide technical assistance to child welfare and mental health agencies;
(6) develop cooperative efforts with other
service entities in the community, including
education, social services, juvenile justice, and
primary health care agencies;

§ 290bb–40

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(7) coordinate services with services provided under the Medicaid program and the
State Children’s Health Insurance Program
under titles XIX and XXI of the Social Security Act [42 U.S.C. 1396 et seq., 1397aa et seq.];
(8) provide linguistically appropriate and
culturally competent services; and
(9) evaluate the effectiveness and cost-efficiency of the integrated services that measure
the level of coordination, outcome measures
for parents or caregivers with a mental illness
or a mental illness and a co-occurring substance abuse disorder, and outcome measures
for children.
(e) Distribution of awards
The Secretary shall ensure that grants, contracts, and cooperative agreements awarded
under subsection (a) of this section are equitably distributed among the geographical regions of the United States and between urban
and rural populations.
(f) Evaluation
The Secretary shall evaluate each program
carried out by a State, political subdivision of a
State, Indian tribe, or tribal organization under
subsection (a) of this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities.
(g) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $10,000,000 for fiscal year
2001, and such sums as may be necessary for
each of fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 520H, as added
Pub. L. 106–310, div. B, title XXXII, § 3211, Oct.
17, 2000, 114 Stat. 1203.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (d)(7),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Titles XIX and XXI of the Act are classified generally
to subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.

§ 290bb–40. Grants for the integrated treatment
of serious mental illness and co-occurring
substance abuse
(a) In general
The Secretary shall award grants, contracts,
or cooperative agreements to States, political
subdivisions of States, Indian tribes, tribal organizations, and private nonprofit organizations
for the development or expansion of programs to
provide integrated treatment services for individuals with a serious mental illness and a cooccurring substance abuse disorder.
(b) Priority
In awarding grants, contracts, and cooperative
agreements under subsection (a) of this section,
the Secretary shall give priority to applicants
that emphasize the provision of services for individuals with a serious mental illness and a cooccurring substance abuse disorder who—
(1) have a history of interactions with law
enforcement or the criminal justice system;

Page 704

(2) have recently been released from incarceration;
(3) have a history of unsuccessful treatment
in either an inpatient or outpatient setting;
(4) have never followed through with outpatient services despite repeated referrals; or
(5) are homeless.
(c) Use of funds
A State, political subdivision of a State, Indian tribe, tribal organization, or private nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) of this section shall use funds received under such grant—
(1) to provide fully integrated services rather than serial or parallel services;
(2) to employ staff that are cross-trained in
the diagnosis and treatment of both serious
mental illness and substance abuse;
(3) to provide integrated mental health and
substance abuse services at the same location;
(4) to provide services that are linguistically
appropriate and culturally competent;
(5) to provide at least 10 programs for integrated treatment of both mental illness and
substance abuse at sites that previously provided only mental health services or only substance abuse services; and
(6) to provide services in coordination with
other existing public and private community
programs.
(d) Condition
The Secretary shall ensure that a State, political subdivision of a State, Indian tribe, tribal
organization, or private nonprofit organization
that receives a grant, contract, or cooperative
agreement under subsection (a) of this section
maintains the level of effort necessary to sustain existing mental health and substance abuse
programs for other populations served by mental health systems in the community.
(e) Distribution of awards
The Secretary shall ensure that grants, contracts, or cooperative agreements awarded
under subsection (a) of this section are equitably distributed among the geographical regions of the United States and between urban
and rural populations.
(f) Duration
The Secretary shall award grants, contract, or
cooperative agreements under this subsection
for a period of not more than 5 years.
(g) Application
A State, political subdivision of a State, Indian tribe, tribal organization, or private nonprofit organization that desires a grant, contract, or cooperative agreement under this subsection shall prepare and submit an application
to the Secretary at such time, in such manner,
and containing such information as the Secretary may require. Such application shall include a plan for the rigorous evaluation of activities funded with an award under such subsection, including a process and outcomes evaluation.
(h) Evaluation
A State, political subdivision of a State, Indian tribe, tribal organization, or private non-

Page 705

TITLE 42—THE PUBLIC HEALTH AND WELFARE

profit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare and submit a plan for the
rigorous evaluation of the program funded under
such grant, contract, or agreement, including
both process and outcomes evaluation, and the
submission of an evaluation at the end of the
project period.
(i) Authorization of appropriation
There is authorized to be appropriated to
carry out this subsection $40,000,000 for fiscal
year 2001, and such sums as may be necessary for
fiscal years 2002 through 2003.
(July 1, 1944, ch. 373, title V, § 520I, as added Pub.
L. 106–310, div. B, title XXXII, § 3212, Oct. 17, 2000,
114 Stat. 1205.)
§ 290bb–41. Training grants
(a) In general
The Secretary shall award grants in accordance with the provisions of this section.
(b) Mental illness awareness training grants
(1) In general
The Secretary shall award grants to States,
political subdivisions of States, Indian tribes,
tribal organizations, and nonprofit private entities to train teachers and other relevant
school personnel to recognize symptoms of
childhood and adolescent mental disorders, to
refer family members to the appropriate mental health services if necessary, to train emergency services personnel to identify and appropriately respond to persons with a mental
illness, and to provide education to such
teachers and personnel regarding resources
that are available in the community for individuals with a mental illness.
(2) Emergency services personnel
In this subsection, the term ‘‘emergency
services personnel’’ includes paramedics, firefighters, and emergency medical technicians.
(3) Distribution of awards
The Secretary shall ensure that such grants
awarded under this subsection are equitably
distributed among the geographical regions of
the United States and between urban and rural
populations.
(4) Application
A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
private entity that desires a grant under this
subsection shall submit an application to the
Secretary at such time, in such manner, and
containing such information as the Secretary
may require, including a plan for the rigorous
evaluation of activities that are carried out
with funds received under a grant under this
subsection.
(5) Use of funds
A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
private entity receiving a grant under this
subsection shall use funds from such grant
to—
(A) train teachers and other relevant
school personnel to recognize symptoms of

§ 290bb–42

childhood and adolescent mental disorders
and appropriately respond;
(B) train emergency services personnel to
identify and appropriately respond to persons with a mental illness; and
(C) provide education to such teachers and
personnel regarding resources that are available in the community for individuals with a
mental illness.
(6) Evaluation
A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
private entity that receives a grant under this
subsection shall prepare and submit an evaluation to the Secretary at such time, in such
manner, and containing such information as
the Secretary may reasonably require, including an evaluation of activities carried out
with funds received under the grant under this
subsection and a process and outcome evaluation.
(7) Authorization of appropriations
There is authorized to be appropriated to
carry out this subsection, $25,000,000 for fiscal
year 2001 and such sums as may be necessary
for each of fiscal years 2002 through 2003.
(July 1, 1944, ch. 373, title V, § 520J, as added Pub.
L. 106–310, div. B, title XXXII, § 3213, Oct. 17, 2000,
114 Stat. 1206.)
§ 290bb–42. Awards for co-locating primary and
specialty care in community-based mental
health settings
(a) Definitions
In this section:
(1) Eligible entity
The term ‘‘eligible entity’’ means a qualified
community mental health program defined
under section 300x–2(b)(1) of this title.
(2) Special populations
The term ‘‘special populations’’ means
adults with mental illnesses who have co-occurring primary care conditions and chronic
diseases.
(b) Program authorized
The Secretary, acting through the Administrator 1 shall award grants and cooperative
agreements to eligible entities to establish demonstration projects for the provision of coordinated and integrated services to special populations through the co-location of primary and
specialty care services in community-based
mental and behavioral health settings.
(c) Application
To be eligible to receive a grant or cooperative
agreement under this section, an eligible entity
shall submit an application to the Administrator at such time, in such manner, and accompanied by such information as the Administrator may require, including a description of
partnerships, or other arrangements with local
primary care providers, including community
health centers, to provide services to special
populations.
1 So

in original. A comma probably should appear.

§§ 290cc to 290cc–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Use of funds
(1) In general
For the benefit of special populations, an eligible entity shall use funds awarded under this
section for—
(A) the provision, by qualified primary
care professionals, of on site primary care
services;
(B) reasonable costs associated with medically necessary referrals to qualified specialty care professionals, other coordinators
of care or, if permitted by the terms of the
grant or cooperative agreement, by 2 qualified specialty care professionals on a reasonable cost basis on site at the eligible entity;
(C) information technology required to accommodate the clinical needs of primary
and specialty care professionals; or
(D) facility modifications needed to bring
primary and specialty care professionals on
site at the eligible entity.
(2) Limitation
Not to exceed 15 percent of grant or cooperative agreement funds may be used for activities described in subparagraphs (C) and (D) of
paragraph (1).
(e) Evaluation
Not later than 90 days after a grant or cooperative agreement awarded under this section expires, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted by the entity concerning the effectiveness of the activities carried out under the grant
or agreement.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $50,000,000 for fiscal year
2010 and such sums as may be necessary for each
of fiscal years 2011 through 2014.
(July 1, 1944, ch.373, title V, § 520K, as added Pub.
L. 111–148, title V, § 5604, Mar. 23, 2010, 124 Stat.
679.)
§§ 290cc to 290cc–12. Repealed. Pub. L. 102–321,
title I, §§ 117, 120(b)(3), 123(c), July 10, 1992,
106 Stat. 348, 358, 363
Section 290cc, act July 1, 1944, ch. 373, title V, § 515,
formerly Pub. L. 92–255, title V, § 503, as added Pub. L.
94–237, § 13(a), Mar. 19, 1976, 90 Stat. 248; amended Pub.
L. 95–461, § 2(c), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 96–181,
§ 12, Jan. 2, 1980, 93 Stat. 1315; Pub. L. 97–35, title IX,
§ 972(a), (b), Aug. 13, 1981, 95 Stat. 597; renumbered § 515
of act July 1, 1944, and amended Apr. 26, 1983, Pub. L.
98–24, § 2(b)(11), 97 Stat. 180; Oct. 19, 1984, Pub. L. 98–509,
title II, §§ 205(a)(2), 206(c)(2), 207(b), 98 Stat. 2361–2363;
Oct. 27, 1986, Pub. L. 99–570, title IV, § 4009, 100 Stat.
3207–115; Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2058(a)(3), 102 Stat. 4214, related to encouraging drug
abuse research.
Section 290cc–1, act July 1, 1944, ch. 373, title V, § 516,
as added Oct. 19, 1984, Pub. L. 98–509, title II, § 206(b), 98
Stat. 2362; amended Nov. 18, 1988, Pub. L. 100–690, title
II, § 2058(a)(4), 102 Stat. 4214, related to drug abuse demonstration projects.
Section 290cc–2, act July 1, 1944, ch. 373, title V, § 517,
as added Oct. 19, 1984, Pub. L. 98–509, title II, § 207(b), 98
Stat. 2363; amended Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4010(b), 100 Stat. 3207–115; Nov. 18, 1988, Pub. L. 100–690,
2 So

in original.

Page 706

title II, § 2056(b), 102 Stat. 4211; Aug. 15, 1990, Pub. L.
101–374, § 3(a), 104 Stat. 457, authorized appropriations
for drug abuse research.
Section 290cc–11, act July 1, 1944, ch. 373, title V, § 518,
formerly § 519, as added Nov. 18, 1988, Pub. L. 100–690,
title II, § 2057(3), 102 Stat. 4212; renumbered § 518, Aug.
16, 1989, Pub. L. 101–93, § 3(e)(1)(A), 103 Stat. 610, related
to establishment of a mental health research program.
Section 290cc–12, act July 1, 1944, ch. 373, title V, § 519,
formerly § 520, as added Nov. 18, 1988, Pub. L. 100–690,
title II, § 2057(3), 102 Stat. 4212; renumbered § 519, Aug.
16, 1989, Pub. L. 101–93, § 3(e)(1)(A), 103 Stat. 610, related
to National Mental Health Education Program.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290cc–13. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title V, § 520, formerly § 520A, as added Nov. 18, 1988, Pub. L. 100–690,
title II, § 2057(3), 102 Stat. 4212, and amended, which related to establishment of grant programs for demonstration projects for drug abuse research, was renumbered section 520A of act July 1, 1944 by Pub. L. 102–321,
title I, § 116(a), July 10, 1992, 106 Stat. 348, and transferred to section 290bb–32 of this title.

PART C—PROJECTS FOR ASSISTANCE IN
TRANSITION FROM HOMELESSNESS
§ 290cc–21. Formula grants to States
For the purpose of carrying out section
290cc–22 of this title, the Secretary, acting
through the Director of the Center for Mental
Health Services, shall for each of the fiscal
years 1991 through 1994 make an allotment for
each State in an amount determined in accordance with section 290cc–24 of this title. The Secretary shall make payments, as grants, each
such fiscal year to each State from the allotment for the State if the Secretary approves for
the fiscal year involved an application submitted by the State pursuant to section 290cc–29 of
this title.
(July 1, 1944, ch. 373, title V, § 521, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
516; amended Pub. L. 100–607, title VIII, § 813(1),
Nov. 4, 1988, 102 Stat. 3170; Pub. L. 100–628, title
VI, § 613(1), Nov. 7, 1988, 102 Stat. 3243; Pub. L.
101–93, § 5(t)(1), Aug. 16, 1989, 103 Stat. 615; Pub.
L. 101–645, title V, § 511, Nov. 29, 1990, 104 Stat.
4726; Pub. L. 102–321, title I, §§ 162(1), 163(a)(1),
July 10, 1992, 106 Stat. 375; Pub. L. 102–352,
§ 2(b)(2), Aug. 26, 1992, 106 Stat. 939.)
PRIOR PROVISIONS
A prior section 521 of act July 1, 1944, was renumbered
section 542 by section 611(2) of Pub. L. 100–77 and is classified to section 290dd–1 of this title.
AMENDMENTS
1992—Pub. L. 102–352 repealed Pub. L. 102–321,
§ 163(a)(1), which directed the substitution of ‘‘Administrator of the Substance Abuse and Mental Health Services Administration’’ for ‘‘Director of the National Institute of Mental Health’’.
Pub. L. 102–321, § 162(1), substituted ‘‘Center for Mental Health Services’’ for ‘‘National Institute of Mental
Health’’.
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to formula grants to

Page 707

TITLE 42—THE PUBLIC HEALTH AND WELFARE

States for provisions relating to establishment of block
grant program for services to homeless individuals who
are chronically mentally ill.
1989—Subsec. (a). Pub. L. 101–93 directed that subsec.
(a) of this section as similarly amended by title VIII of
Pub. L. 100–607 and title VI of Pub. L. 100–628 be amended to read as if the amendments made by title VI of
Pub. L. 100–628 had not been enacted. See 1988 Amendment note below.
1988—Subsec. (a). Pub. L. 100–607 and Pub. L. 100–628
made identical amendments, amending first sentence
generally. Prior to amendment, first sentence read as
follows: ‘‘The Secretary shall for fiscal years 1987 and
1988 allot to each State an amount determined in accordance with sections 290cc–28 and 290cc–29 of this
title.’’
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENTS
Amendment by Pub. L. 100–628 effective Nov.
see section 631 of Pub. L. 100–628, set out as
under section 254e of this title.
Amendment by Pub. L. 100–607 effective Nov.
see section 831 of Pub. L. 100–607, set out as
under section 254e of this title.

7, 1988,
a note
4, 1988,
a note

§ 290cc–22. Purpose of grants
(a) In general
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that the payments will be expended solely for making grants to political subdivisions of the State, and to nonprofit private
entities (including community-based veterans
organizations and other community organizations), for the purpose of providing the services
specified in subsection (b) of this section to individuals who—
(1)(A) are suffering from serious mental illness; or
(B) are suffering from serious mental illness
and from substance abuse; and
(2) are homeless or at imminent risk of becoming homeless.
(b) Specification of services
The services referred to in subsection (a) of
this section are—
(1) outreach services;
(2) screening and diagnostic treatment services;
(3) habilitation and rehabilitation services;
(4) community mental health services;
(5) alcohol or drug treatment services;
(6) staff training, including the training of
individuals who work in shelters, mental
health clinics, substance abuse programs, and
other sites where homeless individuals require
services;
(7) case management services, including—
(A) preparing a plan for the provision of
community mental health services to the eligible homeless individual involved, and reviewing such plan not less than once every 3
months;
(B) providing assistance in obtaining and
coordinating social and maintenance services for the eligible homeless individuals, including services relating to daily living ac-

§ 290cc–22

tivities, personal financial planning, transportation services, and habilitation and rehabilitation services, prevocational and vocational services, and housing services;
(C) providing assistance to the eligible
homeless individual in obtaining income
support services, including housing assistance, supplemental nutrition assistance program benefits, and supplemental security income benefits;
(D) referring the eligible homeless individual for such other services as may be appropriate; and
(E) providing representative payee services
in accordance with section 1631(a)(2) of the
Social Security Act [42 U.S.C. 1383(a)(2)] if
the eligible homeless individual is receiving
aid under title XVI of such act [42 U.S.C. 1381
et seq.] and if the applicant is designated by
the Secretary to provide such services;
(8) supportive and supervisory services in
residential settings;
(9) referrals for primary health services, job
training, educational services, and relevant
housing services;
(10) subject to subsection (h)(1) of this section—
(A) minor renovation, expansion, and repair of housing;
(B) planning of housing;
(C) technical assistance in applying for
housing assistance;
(D) improving the coordination of housing
services;
(E) security deposits;
(F) the costs associated with matching eligible homeless individuals with appropriate
housing situations; and
(G) 1-time rental payments to prevent
eviction; and
(11) other appropriate services, as determined by the Secretary.
(c) Coordination
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees to make grants pursuant to subsection (a) of this section only to entities that
have the capacity to provide, directly or
through arrangements, the services specified in
subsection (b) of this section, including coordinating the provision of services in order to meet
the needs of eligible homeless individuals who
are both mentally ill and suffering from substance abuse.
(d) Special consideration regarding veterans
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that, in making grants to entities
pursuant to subsection (a) of this section, the
State will give special consideration to entities
with a demonstrated effectiveness in serving
homeless veterans.
(e) Special rules
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that grants pursuant to subsection
(a) of this section will not be made to any entity
that—

§ 290cc–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 708

PRIOR PROVISIONS

(1) has a policy of excluding individuals from
mental health services due to the existence or
suspicion of substance abuse; or
(2) has a policy of excluding individuals from
substance abuse services due to the existence
or suspicion of mental illness.

A prior section 522 of act July 1, 1944, was renumbered
section 543 by section 611(2) of Pub. L. 100–77 and is classified to section 290dd–2 of this title.

(f) Administrative expenses
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that not more than 4 percent of
the payments will be expended for administrative expenses regarding the payments.

2008—Subsec. (b)(7)(C). Pub. L. 110–246, § 4002(b)(1)(E),
(2)(U), substituted ‘‘supplemental nutrition assistance
program benefits’’ for ‘‘food stamps’’.
2000—Subsec. (i). Pub. L. 106–310 added subsec. (i).
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to purpose of grants for
provisions relating to requirement of submission of application containing certain agreements.

(g) Maintenance of effort
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that the State will maintain State
expenditures for services specified in subsection
(b) of this section at a level that is not less than
the average level of such expenditures maintained by the State for the 2-year period preceding the fiscal year for which the State is applying to receive such payments.

Amendment of this section and repeal of Pub. L.
110–234 by Pub. L. 110–246 effective May 22, 2008, the
date of enactment of Pub. L. 110–234, except as otherwise provided, see section 4 of Pub. L. 110–246, set out
as an Effective Date note under section 8701 of Title 7,
Agriculture.
Amendment by section 4002(b)(1)(E), (2)(U) of Pub. L.
110–246 effective Oct. 1, 2008, see section 4407 of Pub. L.
110–246, set out as a note under section 1161 of Title 2,
The Congress.

(h) Restrictions on use of funds
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that—
(1) not more than 20 percent of the payments
will be expended for housing services under
subsection (b)(10) of this section; and
(2) the payments will not be expended—
(A) to support emergency shelters or construction of housing facilities;
(B) for inpatient psychiatric treatment
costs or inpatient substance abuse treatment costs; or
(C) to make cash payments to intended recipients of mental health or substance abuse
services.
(i) Waiver for territories
With respect to the United States Virgin Islands, Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the
Northern Mariana Islands, the Secretary may
waive the provisions of this part that the Secretary determines to be appropriate.
(July 1, 1944, ch. 373, title V, § 522, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
516; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4726; Pub. L. 106–310, div. B,
title XXXII, § 3203(a), Oct. 17, 2000, 114 Stat. 1191;
Pub. L. 110–234, title IV, § 4002(b)(1)(E), (2)(U),
May 22, 2008, 122 Stat. 1096, 1097; Pub. L. 110–246,
§ 4(a), title IV, § 4002(b)(1)(E), (2)(U), June 18, 2008,
122 Stat. 1664, 1857, 1858.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(b)(7)(E), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XVI of the Act is classified generally to
subchapter XVI (§ 1381 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
CODIFICATION
Pub. L. 110–234 and Pub. L. 110–246 made identical
amendments to this section. The amendments by Pub.
L. 110–234 were repealed by section 4(a) of Pub. L.
110–246.

AMENDMENTS

EFFECTIVE DATE OF 2008 AMENDMENT

§ 290cc–23. Requirement of matching funds
(a) In general
The Secretary may not make payments under
section 290cc–21 of this title unless, with respect
to the costs of providing services pursuant to
section 290cc–22 of this title, the State involved
agrees to make available, directly or through
donations from public or private entities, nonFederal contributions toward such costs in an
amount that is not less than $1 for each $3 of
Federal funds provided in such payments.
(b) Determination of amount
Non-Federal contributions required in subsection (a) of this section may be in cash or in
kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal
Government, shall not be included in determining the amount of such non-Federal contributions.
(c) Limitation regarding grants by States
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that the State will not require the
entities to which grants are provided pursuant
to section 290cc–22(a) of this title to provide
non-Federal contributions in excess of the nonFederal contributions described in subsection (a)
of this section.
(July 1, 1944, ch. 373, title V, § 523, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
517; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4728.)
PRIOR PROVISIONS
A prior section 523 of act July 1, 1944, was renumbered
section 544 by section 611(2) of Pub. L. 100–77 and is classified to section 290dd–3 of this title.
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting present provisions for provisions which related to: in subsec. (a), general requirements; and in sub-

Page 709

TITLE 42—THE PUBLIC HEALTH AND WELFARE

sec. (b), determination of amount of non-Federal contribution.

§ 290cc–24. Determination of amount of allotment
(a) Minimum allotment
The allotment for a State under section
290cc–21 of this title for a fiscal year shall be the
greater of—
(1) $300,000 for each of the several States, the
District of Columbia, and the Commonwealth
of Puerto Rico, and $50,000 for each of Guam,
the Virgin Islands, American Samoa, and the
Commonwealth of the Northern Mariana Islands; and
(2) an amount determined in accordance
with subsection (b) of this section.
(b) Determination under formula
The amount referred to in subsection (a)(2) of
this section is the product of—
(1) an amount equal to the amount appropriated under section 290cc–35(a) of this title
for the fiscal year; and
(2) a percentage equal to the quotient of—
(A) an amount equal to the population living in urbanized areas of the State involved,
as indicated by the most recent data collected by the Bureau of the Census; and
(B) an amount equal to the population living in urbanized areas of the United States,
as indicated by the sum of the respective
amounts determined for the States under
subparagraph (A).
(July 1, 1944, ch. 373, title V, § 524, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
517; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4728.)
PRIOR PROVISIONS
A prior section 524 of act July 1, 1944, was renumbered
section 545 by section 611(2) of Pub. L. 100–77 and is classified to section 290ee of this title.
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to determination of
amount of allotment for provisions relating to requiring provision of certain mental health services.

§ 290cc–25. Conversion to categorical program in
event of failure of State regarding expenditure of grants
(a) In general
Subject to subsection (c) of this section, the
Secretary shall, from the amounts specified in
subsection (b) of this section, make grants to
public and nonprofit private entities for the purpose of providing to eligible homeless individuals the services specified in section 290cc–22(b)
of this title.
(b) Specification of funds
The amounts referred to in subsection (a) of
this section are any amounts made available in
appropriations Acts for allotments under section 290cc–21 of this title that are not paid to a
State as a result of—
(A) the failure of the State to submit an application under section 290cc–29 of this title;
(B) the failure of the State, in the determination of the Secretary, to prepare the ap-

§ 290cc–26

plication in accordance with such section or to
submit the application within a reasonable period of time; or
(C) the State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State.
(c) Requirement of provision of services in State
involved
With respect to grants under subsection (a) of
this section, amounts made available under subsection (b) of this section as a result of the
State involved shall be available only for grants
to provide services in such State.
(July 1, 1944, ch. 373, title V, § 525, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
518; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4729.)
PRIOR PROVISIONS
A prior section 525 of act July 1, 1944, was renumbered
section 546 by section 611(2) of Pub. L. 100–77 and is classified to section 290ee–1 of this title.
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to conversion to categorical program in event of failure of State regarding expenditure of grants for provisions relating to restrictions on use of payments.

§ 290cc–26. Provision of certain information from
State
The Secretary may not make payments under
section 290cc–21 of this title to a State unless, as
part of the application required in section
290cc–29 of this title, the State submits to the
Secretary a statement—
(1) identifying existing programs providing
services and housing to eligible homeless individuals and identify gaps in the delivery systems of such programs;
(2) containing a plan for providing services
and housing to eligible homeless individuals,
which plan—
(A) describes the coordinated and comprehensive means of providing services and
housing to homeless individuals; and
(B) includes documentation that suitable
housing for eligible homeless individuals
will accompany the provision of services to
such individuals;
(3) describes the source of the non-Federal
contributions described in section 290cc–23 of
this title;
(4) contains assurances that the non-Federal
contributions described in section 290cc–23 of
this title will be available at the beginning of
the grant period;
(5) describe any voucher system that may be
used to carry out this part; and
(6) contain such other information or assurances as the Secretary may reasonably require.
(July 1, 1944, ch. 373, title V, § 526, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
519; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4729.)
PRIOR PROVISIONS
A prior section 526 of act July 1, 1944, was renumbered
section 547 by section 611(2) of Pub. L. 100–77 and is classified to section 290ee–2 of this title.

§ 290cc–27

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1990—Pub. L. 101–645 amended section generally, substituting provisions relating to providing certain information from State for provisions relating to requirement of submission of description of intended use of
block grant.

§ 290cc–27. Description of intended expenditures
of grant
(a) In general
The Secretary may not make payments under
section 290cc–21 of this title unless—
(1) as part of the application required in section 290cc–29 of this title, the State involved
submits to the Secretary a description of the
intended use for the fiscal year of the amounts
for which the State is applying pursuant to
such section;
(2) such description identifies the geographic
areas within the State in which the greatest
numbers of homeless individuals with a need
for mental health, substance abuse, and housing services are located;
(3) such description provides information relating to the programs and activities to be
supported and services to be provided, including information relating to coordinating such
programs and activities with any similar programs and activities of public and private entities; and
(4) the State agrees that such description
will be revised throughout the year as may be
necessary to reflect substantial changes in the
programs and activities assisted by the State
pursuant to section 290cc–22 of this title.
(b) Opportunity for public comment
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that, in developing and carrying
out the description required in subsection (a) of
this section, the State will provide public notice
with respect to the description (including any
revisions) and such opportunities as may be necessary to provide interested persons, such as
family members, consumers, and mental health,
substance abuse, and housing agencies, an opportunity to present comments and recommendations with respect to the description.
(c) Relationship to State comprehensive mental
health services plan
(1) In general
The Secretary may not make payments
under section 290cc–21 of this title unless the
services to be provided pursuant to the description required in subsection (a) of this section are consistent with the State comprehensive mental health services plan required in
subpart 2 1 of part B of subchapter XVII of this
chapter.
(2) Special rule
The Secretary may not make payments
under section 290cc–21 of this title unless the
services to be provided pursuant to the description required in subsection (a) of this section have been considered in the preparation
of, have been included in, and are consistent
1 See

References in Text note below.

Page 710

with, the State comprehensive mental health
services plan referred to in paragraph (1).
(July 1, 1944, ch. 373, title V, § 527, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
520; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4730.)
REFERENCES IN TEXT
Subpart 2 of part B of subchapter XVII of this chapter, referred to in subsec. (c)(1), which related to State
comprehensive mental health services plans and which
was classified to section 300x–10 et seq. of this title, was
repealed by Pub. L. 102–321, title II, § 201(2), July 10,
1992, 106 Stat. 378, and a new subpart 2 of part B of subchapter XVII of this chapter, relating to block grants
for prevention and treatment of substance abuse, was
added by section 202 of Pub. L. 102–321 and classified to
section 300x–21 et seq. of this title.
PRIOR PROVISIONS
A prior section 527 of act July 1, 1944, was renumbered
section 548 by section 611(2) of Pub. L. 100–77 and is classified to section 290ee–3 of this title.
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to description of intended
expenditures of grant for provisions relating to requirement of reports by States.

§ 290cc–28. Requirement of reports by States
(a) In general
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees that, by not later than January 31
of each fiscal year, the State will prepare and
submit to the Secretary a report in such form
and containing such information as the Secretary determines (after consultation with the
Administrator of the Substance Abuse and Mental Health Services Administration) to be necessary for—
(1) securing a record and a description of the
purposes for which amounts received under
section 290cc–21 of this title were expended
during the preceding fiscal year and of the recipients of such amounts; and
(2) determining whether such amounts were
expended in accordance with the provisions of
this part.
(b) Availability to public of reports
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved agrees to make copies of the reports described in subsection (a) of this section available
for public inspection.
(c) Evaluations
The Administrator of the Substance Abuse and
Mental Health Services Administration shall
evaluate at least once every 3 years the expenditures of grants under this part by eligible entities in order to ensure that expenditures are
consistent with the provisions of this part, and
shall include in such evaluation recommendations regarding changes needed in program design or operations.
(July 1, 1944, ch. 373, title V, § 528, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
520; amended Pub. L. 100–607, title VIII, § 812(b),
Nov. 4, 1988, 102 Stat. 3170; Pub. L. 100–628, title

Page 711

TITLE 42—THE PUBLIC HEALTH AND WELFARE

VI, § 612(b), Nov. 7, 1988, 102 Stat. 3243; Pub. L.
100–690, title II, § 2614(a), Nov. 18, 1988, 102 Stat.
4239; Pub. L. 101–93, § 5(t)(1), Aug. 16, 1989, 103
Stat. 615; Pub. L. 101–645, title V, § 511, Nov. 29,
1990, 104 Stat. 4730; Pub. L. 102–321, title I,
§ 163(a)(1), formerly § 163(a)(2), July 10, 1992, 106
Stat. 375, renumbered § 163(a)(1), Pub. L. 102–352,
§ 2(b)(2), Aug. 26, 1992, 106 Stat. 939; Pub. L.
104–316, title I, § 122(c), Oct. 19, 1996, 110 Stat.
3836.)
AMENDMENTS
1996—Subsec. (a). Pub. L. 104–316, § 122(c)(1), struck
out ‘‘the Comptroller General of the United States,
and’’ after ‘‘(after consultation with’’.
Subsec. (c). Pub. L. 104–316, § 122(c)(2), struck out
‘‘Comptroller General of the United States in cooperation with the’’ before ‘‘Administrator’’ and struck out
comma after ‘‘Administration’’.
1992—Subsec. (a). Pub. L. 102–321, § 163(a)(1)(A), as renumbered by Pub. L. 102–352, substituted ‘‘and the Administrator of the Substance Abuse and Mental Health
Services Administration’’ for ‘‘the National Institute of
Mental Health, the National Institute on Alcohol
Abuse and Alcoholism, and the National Institute on
Drug Abuse’’.
Subsec. (c). Pub. L. 102–321, § 163(a)(1)(B), as renumbered by Pub. L. 102–352, substituted ‘‘Administrator of
the Substance Abuse and Mental Health Services Administration’’ for ‘‘National Institute of Mental
Health’’.
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to requirement of reports
by States for provisions relating to determination of
amount of allotments.
1989—Subsec. (a)(1). Pub. L. 101–93 directed that subsec. (a)(1) of this section as similarly amended by title
VIII of Pub. L. 100–607 and title VI of Pub. L. 100–628 be
amended to read as if the amendments made by title VI
of Pub. L. 100–628 had not been enacted. See 1988
Amendment note below.
1988—Subsec. (a)(1). Pub. L. 100–690 substituted ‘‘the
Commonwealth of the Northern Mariana Islands’’ for
‘‘the Northern Mariana Islands’’.
Pub. L. 100–607 and Pub. L. 100–628 made identical
amendments, amending par. (1) generally. Prior to
amendment, par. (1) read as follows: ‘‘$275,000; and’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290cc–30

(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this part.
(July 1, 1944, ch. 373, title V, § 529, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
520; amended Pub. L. 100–607, title VIII, § 811(b),
Nov. 4, 1988, 102 Stat. 3170; Pub. L. 100–628, title
VI, § 611(b), Nov. 7, 1988, 102 Stat. 3243; Pub. L.
101–93, § 5(t)(1), Aug. 16, 1989, 103 Stat. 615; Pub.
L. 101–645, title V, § 511, Nov. 29, 1990, 104 Stat.
4731.)
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to requirement of application for provisions relating to conversion to State categorical program in event of failure of State with respect to expending allotment.
1989—Pub. L. 101–93 directed that this section as similarly amended by title VIII of Pub. L. 100–607 and title
VI of Pub. L. 100–628 be amended to read as if the
amendments made by title VI of Pub. L. 100–628 had not
been enacted. See 1988 Amendment note below.
1988—Pub. L. 100–607 and Pub. L. 100–628 made identical amendments, amending section generally by substituting present provisions for provisions which had
related to: in subsec. (a), additional allotments for certain States; in subsec. (b), description of funds; and in
subsec. (c), determination of amount of allotment.
EFFECTIVE DATE OF 1988 AMENDMENTS
Amendment by Pub. L. 100–628 effective Nov.
see section 631 of Pub. L. 100–628, set out as
under section 254e of this title.
Amendment by Pub. L. 100–607 effective Nov.
see section 831 of Pub. L. 100–607, set out as
under section 254e of this title.

7, 1988,
a note
4, 1988,
a note

§ 290cc–30. Technical assistance
The Secretary, through the agencies of the
Administration, shall provide technical assistance to eligible entities in developing planning
and operating programs in accordance with the
provisions of this part.
(July 1, 1944, ch. 373, title V, § 530, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
521; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4731; Pub. L. 102–321, title I,
§§ 162(2), 163(a)(3), July 10, 1992, 106 Stat. 375; Pub.
L. 102–352, § 2(b)(2), Aug. 26, 1992, 106 Stat. 939.)

EFFECTIVE DATE OF 1988 AMENDMENTS

AMENDMENTS

Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
Amendment by Pub. L. 100–628 effective Nov. 7, 1988,
see section 631 of Pub. L. 100–628, set out as a note
under section 254e of this title.
Amendment by Pub. L. 100–607 effective Nov. 4, 1988,
see section 831 of Pub. L. 100–607, set out as a note
under section 254e of this title.

1992—Pub. L. 102–352 repealed Pub. L. 102–321,
§ 163(a)(3), which directed the substitution of ‘‘the Administrator of the Substance Abuse and Mental Health
Services Administration’’ for ‘‘the National Institute of
Mental Health, the National Institute on Alcohol
Abuse and Alcoholism, and the National Institute on
Drug Abuse’’.
Pub. L. 102–321, § 162(2), which directed the substitution of ‘‘through the agencies of the Administration’’
for ‘‘through the National’’ and all that follows
through ‘‘Abuse’’, was executed by making the substitution for ‘‘through the National Institute of Mental
Health, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse’’ to
reflect the probable intent of Congress.
1990—Pub. L. 101–645 amended section generally, substituting provision relating to technical assistance for
provision relating to disbursement and availability of
funds.

§ 290cc–29. Requirement of application
The Secretary may not make payments under
section 290cc–21 of this title unless the State involved—
(1) submits to the Secretary an application
for the payments containing agreements and
information in accordance with this part;
(2) the agreements are made through certification from the chief executive officer of the
State; and

EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assist-

§ 290cc–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 712

ance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290cc–32. Prohibition
statements

§ 290cc–31. Failure to comply with agreements

(a) In general
(1) A person may not knowingly make or cause
to be made any false statement or representation of a material fact in connection with the
furnishing of items or services for which
amounts may be paid by a State from payments
received by the State under section 290cc–21 of
this title.
(2) A person with knowledge of the occurrence
of any event affecting the right of the person to
receive any amounts from payments made to
the State under section 290cc–21 of this title
may not conceal or fail to disclose any such
event with the intent of securing such an
amount that the person is not authorized to receive or securing such an amount in an amount
greater than the amount the person is authorized to receive.
(b) Criminal penalty for violation of prohibition
Any person who violates a prohibition established in subsection (a) of this section may for
each violation be fined in accordance with title
18 or imprisoned for not more than 5 years, or
both.

(a) Repayment of payments
(1) The Secretary may, subject to subsection
(c) of this section, require a State to repay any
payments received by the State under section
290cc–21 of this title that the Secretary determines were not expended by the State in accordance with the agreements required to be contained in the application submitted by the State
pursuant to section 290cc–29 of this title.
(2) If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against the
amount of any payment due to be paid to the
State under section 290cc–21 of this title.
(b) Withholding of payments
(1) The Secretary may, subject to subsection
(c) of this section, withhold payments due under
section 290cc–21 of this title if the Secretary determines that the State involved is not expending amounts received under such section in accordance with the agreements required to be
contained in the application submitted by the
State pursuant to section 290cc–29 of this title.
(2) The Secretary shall cease withholding payments from a State under paragraph (1) if the
Secretary determines that there are reasonable
assurances that the State will expend amounts
received under section 290cc–21 of this title in
accordance with the agreements referred to in
such paragraph.
(3) The Secretary may not withhold funds
under paragraph (1) from a State for a minor
failure to comply with the agreements referred
to in such paragraph.
(c) Opportunity for hearing
Before requiring repayment of payments under
subsection (a)(1) of this section, or withholding
payments under subsection (b)(1) of this section,
the Secretary shall provide to the State an opportunity for a hearing.
(d) Rule of construction
Notwithstanding any other provision of this
part, a State receiving payments under section
290cc–21 of this title may not, with respect to
any agreements required to be contained in the
application submitted under section 290cc–29 of
this title, be considered to be in violation of any
such agreements by reason of the fact that the
State, in the regular course of providing services
under section 290cc–22(b) of this title to eligible
homeless individuals, incidentally provides services to homeless individuals who are not eligible
homeless individuals.
(July 1, 1944, ch. 373, title V, § 531, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
521; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4731.)
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to failure to comply with
agreements for provision relating to technical assistance.

against

certain

false

(July 1, 1944, ch. 373, title V, § 532, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
521; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4732.)
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to prohibition against certain false statements for provisions relating to failure
to comply with agreements.

§ 290cc–33. Nondiscrimination
(a) In general
(1) Rule of construction regarding certain civil
rights laws
For the purpose of applying the prohibitions
against discrimination on the basis of age
under the Age Discrimination Act of 1975 [42
U.S.C. 6101 et seq.], on the basis of handicap
under section 504 of the Rehabilitation Act of
1973 [29 U.S.C. 794], on the basis of sex under
title IX of the Education Amendments of 1972
[20 U.S.C. 1681 et seq.], or on the basis of race,
color, or national origin under title VI of the
Civil Rights Act of 1964 [42 U.S.C. 2000d et
seq.], programs and activities funded in whole
or in part with funds made available under
section 290cc–21 of this title shall be considered to be programs and activities receiving
Federal financial assistance.
(2) Prohibition
No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity
funded in whole or in part with funds made
available under section 290cc–21 of this title.
(b) Enforcement
(1) Referrals to Attorney General after notice
Whenever the Secretary finds that a State,
or an entity that has received a payment pur-

Page 713

TITLE 42—THE PUBLIC HEALTH AND WELFARE

suant to section 290cc–21 of this title, has
failed to comply with a provision of law referred to in subsection (a)(1) of this section,
with subsection (a)(2) of this section, or with
an applicable regulation (including one prescribed to carry out subsection (a)(2) of this
section), the Secretary shall notify the chief
executive officer of the State and shall request
the chief executive officer to secure compliance. If within a reasonable period of time, not
to exceed 60 days, the chief executive officer
fails or refuses to secure compliance, the Secretary may—
(A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be instituted;
(B) exercise the powers and functions provided by the Age Discrimination Act of 1975
[42 U.S.C. 6101 et seq.], section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], title
IX of the Education Amendments of 1972 [20
U.S.C. 1681 et seq.], or title VI of the Civil
Rights Act of 1964 [42 U.S.C. 2000d et seq.], as
may be applicable; or
(C) take such other actions as may be authorized by law.
(2) Authority of Attorney General
When a matter is referred to the Attorney
General pursuant to paragraph (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
pattern or practice in violation of a provision
of law referred to in subsection (a)(1) of this
section or in violation of subsection (a)(2) of
this section, the Attorney General may bring
a civil action in any appropriate district court
of the United States for such relief as may be
appropriate, including injunctive relief.
(July 1, 1944, ch. 373, title V, § 533, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
522; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4732.)
REFERENCES IN TEXT
The Age Discrimination Act of 1975, referred to in
subsecs. (a)(1) and (b)(1)(B), is title III of Pub. L. 94–135,
Nov. 28, 1975, 89 Stat. 728, as amended, which is classified generally to chapter 76 (§ 6101 et seq.) of this title.
For complete classification of this Act to the Code, see
Short Title note set out under section 6101 of this title
and Tables.
The Education Amendments of 1972, referred to in
subsecs. (a)(1) and (b)(1)(B), is Pub. L. 92–318, June 23,
1972, 86 Stat. 235, as amended. Title IX of the Act,
known as the Patsy Takemoto Mink Equal Opportunity
in Education Act, is classified principally to chapter 38
(§ 1681 et seq.) of Title 20, Education. For complete classification of title IX to the Code, see Short Title note
set out under section 1681 of Title 20 and Tables.
The Civil Rights Act of 1964, referred to in subsecs.
(a)(1) and (b)(1)(B), is Pub. L. 88–352, July 2, 1964, 78
Stat. 241, as amended. Title VI of the Civil Rights Act
of 1964 is classified generally to subchapter V (§ 2000d et
seq.) of chapter 21 of this title. For complete classification of this Act to the Code, see Short Title note set
out under section 2000a of this title and Tables.
AMENDMENTS
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to nondiscrimination for
provision relating to establishment of prohibition
against making certain false statements.

§ 290cc–35

§ 290cc–34. Definitions
For purposes of this part:
(1) Eligible homeless individual
The term ‘‘eligible homeless individual’’
means an individual described in section
290cc–22(a) of this title.
(2) Homeless individual
The term ‘‘homeless individual’’ has the
meaning given such term in section 254b(h)(5)
of this title.
(3) State
The term ‘‘State’’ means each of the several
States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands,
Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
(4) Substance abuse
The term ‘‘substance abuse’’ means the
abuse of alcohol or other drugs.
(July 1, 1944, ch. 373, title V, § 534, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
522; amended Pub. L. 101–645, title V, § 511, Nov.
29, 1990, 104 Stat. 4733; Pub. L. 107–251, title VI,
§ 601(b), Oct. 26, 2002, 116 Stat. 1665.)
AMENDMENTS
2002—Par. (2). Pub. L. 107–251 substituted ‘‘254b(h)(5) ’’
for ‘‘256(r)’’.
1990—Pub. L. 101–645 amended section generally, substituting provisions relating to definitions for provisions relating to nondiscrimination.

§ 290cc–35. Funding
(a) Authorization of appropriations
For the purpose of carrying out this part,
there is authorized to be appropriated $75,000,000
for each of the fiscal years 2001 through 2003.
(b) Effect of insufficient appropriations for minimum allotments
(1) In general
If the amounts made available under subsection (a) of this section for a fiscal year are
insufficient for providing each State with an
allotment under section 290cc–21 of this title
of not less than the applicable amount under
section 290cc–24(a)(1) of this title, the Secretary shall, from such amounts as are made
available under such subsection, make grants
to the States for providing to eligible homeless individuals the services specified in section 290cc–22(b) of this title.
(2) Rule of construction
Paragraph (1) may not be construed to require the Secretary to make a grant under
such paragraph to each State.
(July 1, 1944, ch. 373, title V, § 535, as added Pub.
L. 100–77, title VI, § 611(3), July 22, 1987, 101 Stat.
523; amended Pub. L. 100–607, title VIII, § 811(a),
Nov. 4, 1988, 102 Stat. 3169; Pub. L. 100–628, title
VI, § 611(a), Nov. 7, 1988, 102 Stat. 3242; Pub. L.
101–93, § 5(t)(1), Aug. 16, 1989, 103 Stat. 615; Pub.
L. 101–645, title V, § 511, Nov. 29, 1990, 104 Stat.
4733; Pub. L. 106–310, div. B, title XXXII, § 3203(b),
Oct. 17, 2000, 114 Stat. 1191.)
PRIOR PROVISIONS
A prior section 290cc–36, act July 1, 1944, ch. 373, title
V, § 536, as added July 22, 1987, Pub. L. 100–77, title VI,

§ 290dd

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 611(3), 101 Stat. 523, and amended Nov. 4, 1988, Pub. L.
100–607, title VIII, §§ 802(b)(3), 812(a), 102 Stat. 3169, 3170;
Nov. 7, 1988, Pub. L. 100–628, title VI, §§ 602(b)(3), 612(a),
102 Stat. 3242, 3243; Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2614(b), 102 Stat. 4239; Aug. 16, 1989, Pub. L. 101–93,
§ 5(t)(1), 103 Stat. 615, defined terms used in this part,
prior to the general revision of this part by Pub. L.
101–645.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310 substituted ‘‘fiscal
years 2001 through 2003’’ for ‘‘fiscal years 1991 through
1994’’.
1990—Pub. L. 101–645 amended section generally, substituting present provisions for similar provisions authorizing appropriations and providing for minimum
allotments.
1989—Pub. L. 101–93 directed that this section as similarly amended by title VIII of Pub. L. 100–607 and title
VI of Pub. L. 100–628 be amended to read as if the
amendments made by title VI of Pub. L. 100–628 had not
been enacted. See 1988 Amendment note below.
1988—Pub. L. 100–607 and Pub. L. 100–628 made identical amendments, amending section generally. Prior
to amendment, section read as follows: ‘‘There are authorized to be appropriated to carry out this part
$35,000,000 for fiscal year 1987 and such sums as may be
necessary for fiscal year 1988.’’
EFFECTIVE DATE OF 1988 AMENDMENTS
Amendment by Pub. L. 100–628 effective Nov.
see section 631 of Pub. L. 100–628, set out as
under section 254e of this title.
Amendment by Pub. L. 100–607 effective Nov.
see section 831 of Pub. L. 100–607, set out as
under section 254e of this title.

7, 1988,
a note
4, 1988,
a note

PART D—MISCELLANEOUS PROVISIONS RELATING
TO SUBSTANCE ABUSE AND MENTAL HEALTH
§ 290dd. Substance abuse among government and
other employees
(a) Programs and services
(1) Development
The Secretary, acting through the Administrator of the Substance Abuse and Mental
Health Services Administration, shall be responsible for fostering substance abuse prevention and treatment programs and services in
State and local governments and in private industry.
(2) Model programs
(A) In general
Consistent with the responsibilities described in paragraph (1), the Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services
Administration, shall develop a variety of
model programs suitable for replication on a
cost-effective basis in different types of business concerns and State and local governmental entities.
(B) Dissemination of information
The Secretary, acting through the Administrator of the Substance Abuse and Mental
Health Services Administration, shall disseminate information and materials relative
to such model programs to the State agencies responsible for the administration of
substance abuse prevention, treatment, and
rehabilitation activities and shall, to the extent feasible provide technical assistance to
such agencies as requested.

Page 714

(b) Deprivation of employment
(1) Prohibition
No person may be denied or deprived of Federal civilian employment or a Federal professional or other license or right solely on the
grounds of prior substance abuse.
(2) Application
This subsection shall not apply to employment in—
(A) the Central Intelligence Agency;
(B) the Federal Bureau of Investigation;
(C) the National Security Agency;
(D) any other department or agency of the
Federal Government designated for purposes
of national security by the President; or
(E) in any position in any department or
agency of the Federal Government, not referred to in subparagraphs (A) through (D),
which position is determined pursuant to
regulations prescribed by the head of such
agency or department to be a sensitive position.
(3) Rehabilitation Act
The inapplicability of the prohibition described in paragraph (1) to the employment described in paragraph (2) shall not be construed
to reflect on the applicability of the Rehabilitation Act of 1973 [29 U.S.C. 701 et seq.] or
other anti-discrimination laws to such employment.
(c) Construction
This section shall not be construed to prohibit
the dismissal from employment of a Federal civilian employee who cannot properly function in
his employment.
(July 1, 1944, ch. 373, title V, § 541, formerly Pub.
L. 91–616, title III, § 301, Dec. 31, 1970, 84 Stat.
1849, as amended Pub. L. 92–554, Oct. 25, 1972, 86
Stat. 1167; Pub. L. 93–282, title I, § 105(a), May 14,
1974, 88 Stat. 127; Pub. L. 94–371, § 3(a), July 26,
1976, 90 Stat. 1035; Pub. L. 96–180, § 7, Jan. 2, 1980,
93 Stat. 1303; Pub. L. 97–35, title IX, § 962(a), Aug.
13, 1981, 95 Stat. 592; renumbered § 520 of act July
1, 1944, and amended Pub. L. 98–24, § 2(b)(13), Apr.
26, 1983, 97 Stat. 181; Pub. L. 98–509, title III,
§ 301(c)(2), Oct. 19, 1984, 98 Stat. 2364; renumbered
§ 541, Pub. L. 100–77, title VI, § 611(2), July 22,
1987, 101 Stat. 516; Pub. L. 100–607, title VIII,
§ 813(2), Nov. 4, 1988, 102 Stat. 3170; Pub. L.
100–628, title VI, § 613(2), Nov. 7, 1988, 102 Stat.
3243; Pub. L. 101–93, § 5(t)(1), Aug. 16, 1989, 103
Stat. 615; Pub. L. 102–321, title I, § 131, July 10,
1992, 106 Stat. 366.)
REFERENCES IN TEXT
The Rehabilitation Act of 1973, referred to in subsec.
(b)(3), is Pub. L. 93–112, Sept. 26, 1973, 87 Stat. 355, as
amended, which is classified principally to chapter 16
(§ 701 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see Short Title note set
out under section 701 of Title 29 and Tables.
CODIFICATION
Section was formerly classified to section 4571 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1992—Pub. L. 102–321 amended section generally, substituting provisions relating to substance abuse among

Page 715

TITLE 42—THE PUBLIC HEALTH AND WELFARE

government and other employees for provisions relating to technical assistance to States relative to alcohol
abuse and alcoholism programs.
1989—Subsec. (a)(4). Pub. L. 101–93 directed that subsec. (a)(4) of this section as similarly amended by title
VIII of Pub. L. 100–607 and title VI of Pub. L. 100–628 be
amended to read as if the amendments made by title VI
of Pub. L. 100–628 had not been enacted. See 1988
Amendment note below.
1988—Subsec. (a)(4). Pub. L. 100–607 and Pub. L. 100–628
made identical technical amendments to reference to
section 290dd–2 of this title to reflect renumbering of
corresponding section of original act.
1984—Pub. L. 98–509 amended directory language of
Pub. L. 98–24, § 2(b)(13). See 1983 Amendment note
below.
1983—Pub. L. 98–24, § 2(b)(13), as amended by Pub. L.
98–509 renumbered section 4571 of this title as this section.
Subsec. (a). Pub. L. 98–24, § 2(b)(13)(A)(i), substituted
‘‘the National Institute on Alcohol Abuse and Alcoholism’’ for ‘‘the Institute’’.
Subsec. (a)(4). Pub. L. 98–24, § 2(b)(13)(A)(ii), substituted ‘‘section 290dd–2 of this title’’ for ‘‘section 4581
of this title’’.
Subsec. (b). Pub. L. 98–24, § 2(b)(13)(A)(iii), substituted
‘‘this subchapter’’ for references to ‘‘this chapter’’,
meaning chapter 60 (§ 4541 et seq.) of this title, and the
Drug Abuse Prevention, Treatment, and Rehabilitation
Act [21 U.S.C. 1101 et seq.].
1981—Pub. L. 97–35 restructured provisions and substituted provisions relating to technical assistance for
enumerated activities, and improvement of coordination with Drug Abuse Prevention, Treatment, and Rehabilitation Act, for provisions authorizing appropriations through fiscal year ending Sept. 30, 1981, for covered activities.
1980—Pub. L. 96–180 authorized appropriation of
$60,000,000 and $65,000,000 for fiscal years ending Sept.
30, 1980, and 1981.
1976—Pub. L. 94–371 struck out ‘‘and’’ after ‘‘1975’’ and
inserted provisions authorizing $70,000,000 to be appropriated for fiscal year ending Sept. 30, 1977, $77,000,000
to be appropriated for fiscal year ending Sept. 30, 1978,
and $85,000,000 to be appropriated for fiscal year ending
Sept. 30, 1979.
1974—Pub. L. 93–282 authorized appropriation of
$80,000,000 for fiscal years ending June 30, 1975 and June
30, 1976.
1972—Pub. L. 92–554 substituted ‘‘for each of the next
two fiscal years’’ for ‘‘for the fiscal year ending June
30, 1973’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENTS
Amendment by Pub. L. 100–628 effective Nov.
see section 631 of Pub. L. 100–628, set out as
under section 254e of this title.
Amendment by Pub. L. 100–607 effective Nov.
see section 831 of Pub. L. 100–607, set out as
under section 254e of this title.

7, 1988,
a note
4, 1988,
a note

§ 290dd–1. Admission of substance abusers to private and public hospitals and outpatient facilities
(a) Nondiscrimination
Substance abusers who are suffering from
medical conditions shall not be discriminated
against in admission or treatment, solely because of their substance abuse, by any private or
public general hospital, or outpatient facility
(as defined in section 300s–3(4) of this title)

§ 290dd–1

which receives support in any form from any
program supported in whole or in part by funds
appropriated to any Federal department or
agency.
(b) Regulations
(1) In general
The Secretary shall issue regulations for the
enforcement of the policy of subsection (a) of
this section with respect to the admission and
treatment of substance abusers in hospitals
and outpatient facilities which receive support
of any kind from any program administered by
the Secretary. Such regulations shall include
procedures for determining (after opportunity
for a hearing if requested) if a violation of subsection (a) of this section has occurred, notification of failure to comply with such subsection, and opportunity for a violator to comply with such subsection. If the Secretary determines that a hospital or outpatient facility
subject to such regulations has violated subsection (a) of this section and such violation
continues after an opportunity has been afforded for compliance, the Secretary may suspend or revoke, after opportunity for a hearing, all or part of any support of any kind received by such hospital from any program administered by the Secretary. The Secretary
may consult with the officials responsible for
the administration of any other Federal program from which such hospital or outpatient
facility receives support of any kind, with respect to the suspension or revocation of such
other Federal support for such hospital or outpatient facility.
(2) Department of Veterans Affairs
The Secretary of Veterans Affairs, acting
through the Under Secretary for Health, shall,
to the maximum feasible extent consistent
with their responsibilities under title 38, prescribe regulations making applicable the regulations prescribed by the Secretary under
paragraph (1) to the provision of hospital care,
nursing home care, domiciliary care, and medical services under such title 38 to veterans
suffering from substance abuse. In prescribing
and implementing regulations pursuant to
this paragraph, the Secretary shall, from time
to time, consult with the Secretary of Health
and Human Services in order to achieve the
maximum possible coordination of the regulations, and the implementation thereof, which
they each prescribe.
(July 1, 1944, ch. 373, title V, § 542, formerly Pub.
L. 91–616, title II, § 201, Dec. 31, 1970, 84 Stat. 1849,
as amended Pub. L. 96–180, § 6(a), (b)(1), (2)(B),
Jan. 2, 1980, 93 Stat. 1302, 1303; Pub. L. 97–35, title
IX, §§ 961, 966(d), (e), Aug. 13, 1981, 95 Stat. 592,
595; renumbered § 521 of act July 1, 1944, and
amended Pub. L. 98–24, § 2(b)(13), Apr. 26, 1983, 97
Stat. 181; Pub. L. 98–509, title III, § 301(c)(2), Oct.
19, 1984, 98 Stat. 2364; Pub. L. 99–570, title VI,
§ 6002(b)(1), Oct. 27, 1986, 100 Stat. 3207–158; renumbered § 542, Pub. L. 100–77, title VI, § 611(2),
July 22, 1987, 101 Stat. 516; Pub. L. 102–321, title
I, § 131, July 10, 1992, 106 Stat. 368; Pub. L.
103–446, title XII, § 1203(a)(2), Nov. 2, 1994, 108
Stat. 4689.)

§ 290dd–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE
CODIFICATION

Section was formerly classified to section 4561 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1994—Subsec. (b)(2). Pub. L. 103–446 substituted
‘‘Under Secretary for Health’’ for ‘‘Chief Medical Director’’.
1992—Pub. L. 102–321 amended section generally, substituting provisions relating to admission of substance
abusers to private and public hospitals and outpatient
facilities for provisions relating to programs for government and other employees.
1986—Subsec. (a). Pub. L. 99–570, § 6002(b)(1), redesignated subsec. (b) as (a), struck out ‘‘similar’’ after ‘‘fostering and encouraging’’ in par. (1), and struck out
former subsec. (a) which read as follows: ‘‘The Office of
Personnel Management shall be responsible for developing and maintaining, in cooperation with the Secretary and with other Federal agencies and departments, and in accordance with the provisions of subpart F of part III of title 5, appropriate prevention,
treatment, and rehabilitation programs and services
for alcohol abuse and alcoholism among Federal civilian employees, consistent with the purposes of this
chapter. Such agencies and departments are encouraged to extend, to the extent feasible, these programs
and services to the families of alcoholic employees and
to employees who have family members who are alcoholics. Such policies and services shall make optimal
use of existing governmental facilities, services, and
skills.’’
Subsecs. (b) to (d). Pub. L. 99–570, § 6002(b)(1)(C), redesignated subsecs. (c) and (d) as (b) and (c), respectively.
Former subsec. (b) redesignated (a).
1984—Pub. L. 98–509 amended directory language of
Pub. L. 98–24, § 2(b)(13). See 1983 Amendment note
below.
1983—Pub. L. 98–24, § 2(b)(13), as amended by Pub. L.
98–509, renumbered section 4561 of this title as this section.
Subsec. (b)(4). Pub. L. 98–24, § 2(b)(13)(B)(i), substituted ‘‘section 290ee–1 of this title’’ for ‘‘section
1180(b) of title 21’’.
Subsec. (d). Pub. L. 98–24, § 2(b)(13)(B)(ii), substituted
‘‘this section’’ for ‘‘this subchapter’’, meaning subchapter II (§ 4561 et seq.) of chapter 60 of this title.
1981—Subsec. (b). Pub. L. 97–35, §§ 961, 966(d), made
changes in nomenclature, and substituted provisions
relating to responsible State administrative agencies,
for provisions relating to single State agencies designated pursuant to section 4573 of this title.
1980—Pub. L. 96–180, § 6(b)(2)(A), amended section
catchline.
Subsec. (a). Pub. L. 96–180, § 6(a), substituted ‘‘Office
of Personnel Management’’ for ‘‘Civil Service Commission’’ and inserted provisions that require compliance
with provisions of subpart F of part III of title 5 and encourage agencies and departments to extend the programs and services to the families of alcoholic employees and to employees who have family members who
are alcoholics.
Subsec. (b). Pub. L. 96–180, § 6(b)(1), designated existing provisions as par. (1), made the Secretary responsible for encouragement of programs and services, required the programs and services to be designed for application to families of employees and to employees
who have family members who are alcoholics, and
added pars. (2) to (4).
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 290dd–2. Confidentiality of records
(a) Requirement
Records of the identity, diagnosis, prognosis,
or treatment of any patient which are main-

Page 716

tained in connection with the performance of
any program or activity relating to substance
abuse education, prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the
United States shall, except as provided in subsection (e) of this section, be confidential and be
disclosed only for the purposes and under the
circumstances expressly authorized under subsection (b) of this section.
(b) Permitted disclosure
(1) Consent
The content of any record referred to in subsection (a) of this section may be disclosed in
accordance with the prior written consent of
the patient with respect to whom such record
is maintained, but only to such extent, under
such circumstances, and for such purposes as
may be allowed under regulations prescribed
pursuant to subsection (g) of this section.
(2) Method for disclosure
Whether or not the patient, with respect to
whom any given record referred to in subsection (a) of this section is maintained, gives
written consent, the content of such record
may be disclosed as follows:
(A) To medical personnel to the extent
necessary to meet a bona fide medical emergency.
(B) To qualified personnel for the purpose
of conducting scientific research, management audits, financial audits, or program
evaluation, but such personnel may not
identify, directly or indirectly, any individual patient in any report of such research,
audit, or evaluation, or otherwise disclose
patient identities in any manner.
(C) If authorized by an appropriate order of
a court of competent jurisdiction granted
after application showing good cause therefor, including the need to avert a substantial
risk of death or serious bodily harm. In assessing good cause the court shall weigh the
public interest and the need for disclosure
against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such
order, the court, in determining the extent
to which any disclosure of all or any part of
any record is necessary, shall impose appropriate safeguards against unauthorized disclosure.
(c) Use of records in criminal proceedings
Except as authorized by a court order granted
under subsection (b)(2)(C) of this section, no
record referred to in subsection (a) of this section may be used to initiate or substantiate any
criminal charges against a patient or to conduct
any investigation of a patient.
(d) Application
The prohibitions of this section continue to
apply to records concerning any individual who
has been a patient, irrespective of whether or
when such individual ceases to be a patient.
(e) Nonapplicability
The prohibitions of this section do not apply
to any interchange of records—

Page 717

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) within the Uniformed Services or within
those components of the Department of Veterans Affairs furnishing health care to veterans;
or
(2) between such components and the Uniformed Services.
The prohibitions of this section do not apply to
the reporting under State law of incidents of
suspected child abuse and neglect to the appropriate State or local authorities.
(f) Penalties
Any person who violates any provision of this
section or any regulation issued pursuant to this
section shall be fined in accordance with title 18.
(g) Regulations
Except as provided in subsection (h) of this
section, the Secretary shall prescribe regulations to carry out the purposes of this section.
Such regulations may contain such definitions,
and may provide for such safeguards and procedures, including procedures and criteria for the
issuance and scope of orders under subsection
(b)(2)(C) of this section, as in the judgment of
the Secretary are necessary or proper to effectuate the purposes of this section, to prevent
circumvention or evasion thereof, or to facilitate compliance therewith.
(h) Application to Department of Veterans Affairs
The Secretary of Veterans Affairs, acting
through the Under Secretary for Health, shall,
to the maximum feasible extent consistent with
their responsibilities under title 38, prescribe
regulations making applicable the regulations
prescribed by the Secretary of Health and
Human Services under subsection (g) of this section to records maintained in connection with
the provision of hospital care, nursing home
care, domiciliary care, and medical services
under such title 38 to veterans suffering from
substance abuse. In prescribing and implementing regulations pursuant to this subsection, the
Secretary of Veterans Affairs shall, from time
to time, consult with the Secretary of Health
and Human Services in order to achieve the
maximum possible coordination of the regulations, and the implementation thereof, which
they each prescribe.
(July 1, 1944, ch. 373, title V, § 543, formerly Pub.
L. 91–616, title III, § 321, Dec. 31, 1970, 84 Stat.
1852, as amended Pub. L. 93–282, title I, § 121(a),
May 14, 1974, 88 Stat. 130; Pub. L. 94–371, § 11(a),
(b), July 26, 1976, 90 Stat. 1041; Pub. L. 94–581,
title I, § 111(c)(1), Oct. 21, 1976, 90 Stat. 2852; renumbered § 522 of act July 1, 1944, and amended
Pub. L. 98–24, § 2(b)(13), Apr. 26, 1983, 97 Stat. 181;
renumbered § 543, Pub. L. 100–77, title VI, § 611(2),
July 22, 1987, 101 Stat. 516; Pub. L. 102–321, title
I, § 131, July 10, 1992, 106 Stat. 368; Pub. L.
102–405, title III, § 302(e)(1), Oct. 9, 1992, 106 Stat.
1985; Pub. L. 105–392, title IV, § 402(c), Nov. 13,
1998, 112 Stat. 3588.)
CODIFICATION
Section was formerly classified to section 4581 of this
title prior to renumbering by Pub. L. 98–24.
AMENDMENTS
1998—Subsec. (e)(1), (2). Pub. L. 105–392 substituted
‘‘Uniformed Services’’ for ‘‘Armed Forces’’.

§ 290dd–2

1992—Pub. L. 102–405 substituted ‘‘Under Secretary for
Health’’ for ‘‘Chief Medical Director’’ in subsec. (h).
Pub. L. 102–321 amended section generally, substituting provisions relating to confidentiality of records for
provisions relating to admission of alcohol abusers and
alcoholics to general hospitals and outpatient facilities.
1983—Pub. L. 98–24, § 2(b)(13), renumbered section 4581
of this title as this section.
Subsec. (a). Pub. L. 98–24, § 2(b)(13)(C), made a technical amendment to reference to section 300s–3 of this
title.
1976—Subsec. (a). Pub. L. 94–371, § 11(a), inserted ‘‘, or
outpatient facility (as defined in section 300s–3(6) of
this title)’’ after ‘‘hospital’’.
Subsec. (b)(1). Pub. L. 94–371, § 11(b), inserted ‘‘and
outpatient facilities’’ after ‘‘hospitals’’, and ‘‘or outpatient facility’’ after ‘‘hospital’’ wherever appearing,
and substituted ‘‘shall issue regulations not later than
December 31, 1976’’ for ‘‘is authorized to make regulations’’.
Subsec. (b)(2). Pub. L. 94–581 provided that subsec.
(b)(2), which directed the Administrator of Veteran’s
Affairs, through the Chief Medical Director, to prescribe regulations making applicable the regulations
prescribed by the Secretary under subsec. (b)(1) to the
provision of hospital care, nursing home care, domiciliary care, and medical services under title 38 to veterans suffering from alcohol abuse or alcoholism and to
consult with the Secretary in order to achieve the maximum possible coordination of the regulations, and the
implementation thereof, which they each prescribed,
was superseded by section 4131 [now 7331] et seq. of
Title 38, Veterans’ Benefits.
1974—Subsec. (a). Pub. L. 93–282, in revising text, prohibited discrimination because of alcohol abuse, substituted provisions respecting eligibility for admission
and treatment based on suffering from medical conditions for former provision based on medical need and
ineligibility, because of discrimination, for support in
any form from any program supported in whole or in
part by funds appropriated to any Federal department
or agency for former requirement for treatment by a
general hospital which received Federal funds, and deleted prohibition against receiving Federal financial
assistance for violation of section and for termination
of Federal assistance on failure to comply, now incorporated in regulation authorization of subsec. (b) of
this section.
Subsec. (b). Pub. L. 93–282 substituted provisions respecting issuance of regulations by the Secretary concerning enforcement procedures and suspension or revocation of Federal support and by the Administrator
concerning applicable regulations for veterans, and for
coordination of the respective regulations for former
provisions respecting judicial review.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–581 effective Oct. 21, 1976,
see section 211 of Pub. L. 94–581, set out as a note under
section 111 of Title 38, Veterans’ Benefits.
REPORT OF ADMINISTRATOR OF VETERANS’ AFFAIRS TO
CONGRESSIONAL COMMITTEES; PUBLICATION IN FEDERAL REGISTER
Section 121(b) of Pub. L. 93–282, which directed Administrator of Veterans’ Affairs to submit to appropriate committees of House of Representatives and
Senate a full report (1) on regulations (including guidelines, policies, and procedures thereunder) he had prescribed pursuant to section 321(b)(2) of Comprehensive
Alcohol Abuse and Alcoholism Prevention, Treatment,
and Rehabilitation Act of 1970 [former subsec. (b)(2) of

§§ 290dd–3 to 290ee–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this section], (2) explaining bases for any inconsistency
between such regulations and regulations of Secretary
under section 321(b)(1) of such Act [subsec. (b)(1) of this
section], (3) on extent, substance, and results of his
consultations with Secretary respecting prescribing
and implementation of Administrator’s regulations,
and (4) containing such recommendations for legislation and administrative actions as he determined were
necessary and desirable, with Administrator to submit
report not later than sixty days after effective date of
regulations prescribed by Secretary under such section
321(b)(1) [subsec. (b)(1) of this section], and to publish
such report in Federal Register, was characterized by
section 111(c)(5) of Pub. L. 94–581 as having been superseded by section 4134 [now 7334] of Title 38, Veterans’
Benefits.

§§ 290dd–3 to 290ee–3. Omitted
CODIFICATION
Sections 290dd–3 to 290ee–3 were omitted in the general revision of this part by Pub. L. 102–321.
Section 290dd–3, act July 1, 1944, ch. 373, title V, § 544,
formerly Pub. L. 91–616, title III, § 333, Dec. 31, 1970, 84
Stat. 1853, as amended Pub. L. 93–282, title I, § 122(a),
May 14, 1974, 88 Stat. 131; Pub. L. 94–581, title I,
§ 111(c)(4), Oct. 21, 1976, 90 Stat. 2852; renumbered § 523 of
act July 1, 1944, Apr. 26, 1983, Pub. L. 98–24, § 2(b)(13), 97
Stat. 181; Aug. 27, 1986, Pub. L. 99–401, title I, § 106(a), 100
Stat. 907; renumbered § 544, July 22, 1987, Pub. L. 100–77,
title VI, § 611(2), 101 Stat. 516; June 13, 1991, Pub. L.
102–54, § 13(q)(1)(A)(ii), 105 Stat. 278, related to confidentiality of patient records for alcohol abuse and alcoholism programs. See section 290dd–2 of this title.
Section 290ee, act July 1, 1944, ch. 373, title V, § 545,
formerly Pub. L. 92–255, title V, § 502, as added Pub. L.
94–237, § 12(b)(1), Mar. 19, 1976, 90 Stat. 247, and amended
Pub. L. 95–461, § 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L.
96–181, § 11, Jan. 2, 1980, 93 Stat. 1315; renumbered § 524 of
act July 1, 1944, and amended Apr. 26, 1983, Pub. L.
98–24, § 2(b)(15), 97 Stat. 181; renumbered § 545, July 22,
1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat. 516; Nov.
4, 1988, Pub. L. 100–607, title VIII, § 813(3), 102 Stat. 3170;
Nov. 7, 1988, Pub. L. 100–628, title VI, § 613(3), 102 Stat.
3243; Aug. 16, 1989, Pub. L. 101–93, § 5(t)(1), 103 Stat. 615,
related to technical assistance to State and local agencies by National Institute on Drug Abuse.
Section 290ee–1, act July 1, 1944, ch. 373, title V, § 546,
formerly Pub. L. 92–255, title IV, § 413, Mar. 21, 1972, 86
Stat. 84, as amended Pub. L. 96–181, § 8(a), (b)(1), Jan. 2,
1980, 93 Stat. 1313, 1314; Pub. L. 97–35, title IX, § 973(e),
Aug. 13, 1981, 95 Stat. 598; renumbered § 525 of act July
1, 1944, and amended Apr. 26, 1983, Pub. L. 98–24,
§ 2(b)(16)(A), 97 Stat. 182; Oct. 27, 1986, Pub. L. 99–570,
title VI, § 6002(b)(2), 100 Stat. 3207–159; renumbered § 546,
July 22, 1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat.
516; Nov. 4, 1988, Pub. L. 100–607, title VIII, § 813(4), 102
Stat. 3171; Nov. 7, 1988, Pub. L. 100–628, title VI, § 613(4),
102 Stat. 3243; Aug. 16, 1989, Pub. L. 101–93, § 5(t)(1), 103
Stat. 615, related to drug abuse among government and
other employees.
Section 290ee–2, act July 1, 1944, ch. 373, title V, § 547,
formerly Pub. L. 92–255, title IV, § 407, Mar. 21, 1972, 86
Stat. 78, as amended Pub. L. 94–237, § 6(a), Mar. 19, 1976,
90 Stat. 244; Pub. L. 94–581, title I, § 111(c)(2), Oct. 21,
1976, 90 Stat. 2852; renumbered § 526 of act July 1, 1944,
Apr. 26, 1983. Pub. L. 98–24, § 2(b)(16)(B), 97 Stat. 182; renumbered § 547, July 22, 1987, Pub. L. 100–77, title VI,
§ 611(2), 101 Stat. 516, related to admission of drug abusers to private and public hospitals.
Section 290ee–3, act July 1, 1944, ch. 373, title V, § 548,
formerly Pub. L. 92–255, title IV, § 408, Mar. 21, 1972, 86
Stat. 79, as amended Pub. L. 93–282, title III, § 303(a), (b),
May 14, 1974, 88 Stat. 137, 138; Pub. L. 94–237, § 4(c)(5)(A),
Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I,
§ 111(c)(3), Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97–35, title
IX, § 973(d), Aug. 13, 1981, 95 Stat. 598; renumbered § 527
of act July 1, 1944, and amended Apr. 26, 1983, Pub. L.
98–24, § 2(b)(16)(B), 97 Stat. 182; Aug. 27, 1986, Pub. L.
99–401, title I, § 106(b), 100 Stat. 907; renumbered § 548,

Page 718

July 22, 1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat.
516; June 13, 1991, Pub. L. 102–54, § 13(q)(1)(A)(iii), (B)(ii),
105 Stat. 278, related to confidentiality of patient
records for drug abuse programs. See section 290dd–2 of
this title.

PART E—CHILDREN WITH SERIOUS EMOTIONAL
DISTURBANCES
§ 290ff. Comprehensive community mental health
services for children with serious emotional
disturbances
(a) Grants to certain public entities
(1) In general
The Secretary, acting through the Director
of the Center for Mental Health Services, shall
make grants to public entities for the purpose
of providing comprehensive community mental health services to children with a serious
emotional disturbance.
(2) ‘‘Public entity’’ defined
For purposes of this part, the term ‘‘public
entity’’ means any State, any political subdivision of a State, and any Indian tribe or
tribal organization (as defined in section
450b(b) and section 450b(c) 1 of title 25).
(b) Considerations in making grants
(1) Requirement of status as grantee under
part B of subchapter XVII
The Secretary may make a grant under subsection (a) of this section to a public entity
only if—
(A) in the case of a public entity that is a
State, the State is a grantee under section
300x of this title;
(B) in the case of a public entity that is a
political subdivision of a State, the State in
which the political subdivision is located is
such a grantee; and
(C) in the case of a public entity that is an
Indian tribe or tribal organization, the State
in which the tribe or tribal organization is
located is such a grantee.
(2) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under subsection (a)
of this section only if, in the case of any service under such subsection that is covered in
the State plan approved under title XIX of the
Social Security Act [42 U.S.C. 1396 et seq.] for
the State involved—
(i) the public entity involved will provide
the service directly, and the entity has entered into a participation agreement under
the State plan and is qualified to receive
payments under such plan; or
(ii) the public entity will enter into an
agreement with an organization under which
the organization will provide the service,
and the organization has entered into such a
participation agreement and is qualified to
receive such payments.
(B)(i) In the case of an organization making
an agreement under subparagraph (A)(ii) regarding the provision of services under subsection (a) of this section, the requirement es1 See

References in Text note below.

Page 719

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tablished in such subparagraph regarding a
participation agreement shall be waived by
the Secretary if the organization does not, in
providing health or mental health services,
impose a charge or accept reimbursement
available from any third-party payor, including reimbursement under any insurance policy
or under any Federal or State health benefits
program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the
public.
(3) Certain considerations
In making grants under subsection (a) of
this section, the Secretary shall—
(A) equitably allocate such assistance
among the principal geographic regions of
the United States;
(B) consider the extent to which the public
entity involved has a need for the grant; and
(C) in the case of any public entity that is
a political subdivision of a State or that is
an Indian tribe or tribal organization—
(i) shall consider any comments regarding the application of the entity for such a
grant that are received by the Secretary
from the State in which the entity is located; and
(ii) shall give special consideration to
the entity if the State agrees to provide a
portion of the non-Federal contributions
required in subsection (c) of this section
regarding such a grant.
(c) Matching funds
(1) In general
A funding agreement for a grant under subsection (a) of this section is that the public entity involved will, with respect to the costs to
be incurred by the entity in carrying out the
purpose described in such subsection, make
available (directly or through donations from
public or private entities) non-Federal contributions toward such costs in an amount
that—
(A) for the first fiscal year for which the
entity receives payments from a grant under
such subsection, is not less than $1 for each
$3 of Federal funds provided in the grant;
(B) for any second or third such fiscal
year, is not less than $1 for each $3 of Federal funds provided in the grant;
(C) for any fourth such fiscal year, is not
less than $1 for each $1 of Federal funds provided in the grant; and
(D) for any fifth and sixth such fiscal
year,2 is not less than $2 for each $1 of Federal funds provided in the grant.
(2) Determination of amount contributed
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to
2 So

in original. Probably should be ‘‘years,’’.

§ 290ff

any significant extent by the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
(B) In making a determination of the
amount of non-Federal contributions for purposes of subparagraph (A), the Secretary may
include only non-Federal contributions in excess of the average amount of non-Federal
contributions made by the public entity involved toward the purpose described in subsection (a) of this section for the 2-year period
preceding the first fiscal year for which the
entity receives a grant under such section.
(July 1, 1944, ch. 373, title V, § 561, as added Pub.
L. 102–321, title I, § 119, July 10, 1992, 106 Stat.
349; amended Pub. L. 103–43, title XX, § 2017(1),
June 10, 1993, 107 Stat. 218; Pub. L. 106–310, div.
B, title XXXI, § 3105(a), Oct. 17, 2000, 114 Stat.
1175.)
REFERENCES IN TEXT
Subsections (b) and (c) of section 450b of title 25, referred to in subsec. (a)(2), do not contain definitions of
the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’.
However, such terms are defined elsewhere in section
450b of Title 25, Indians.
The Social Security Act, referred to in subsec.
(b)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 290ff, act July 1, 1944, ch. 373, title V,
§ 561, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2081(a), 102 Stat. 4216, which related to action by National Institute on Drug Abuse and States concerning
military facilities, was renumbered section 513 of act
July 1, 1944, by Pub. L. 102–321 and transferred to section 290bb–6 of this title.
AMENDMENTS
2000—Subsec. (c)(1)(D). Pub. L. 106–310 substituted
‘‘fifth and sixth such fiscal year’’ for ‘‘fifth such fiscal
year’’.
1993—Subsec. (a)(2). Pub. L. 103–43, § 2017(1)(A), substituted ‘‘this part’’ for ‘‘this subpart’’.
Subsec. (b)(1)(B), (C). Pub. L. 103–43, § 2017(1)(B), substituted ‘‘is such a grantee’’ for ‘‘is receiving such payments’’.
EFFECTIVE DATE
Part effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
CURRENT GRANTEES
Pub. L. 106–310, div. B, title XXXI, § 3105(e), Oct. 17,
2000, 114 Stat. 1175, provided that:
‘‘(1) IN GENERAL.—Entities with active grants under
section 561 of the Public Health Service Act (42 U.S.C.
290ff) on the date of the enactment of this Act [Oct. 17,
2000] shall be eligible to receive a sixth year of funding
under the grant in an amount not to exceed the amount
that such grantee received in the fifth year of funding
under such grant. Such sixth year may be funded without requiring peer and Advisory Council review as required under section 504 of such Act (42 U.S.C. 290aa–3).
‘‘(2) LIMITATION.—Paragraph (1) shall apply with respect to a grantee only if the grantee agrees to comply
with the provisions of section 561 as amended by subsection (a).’’

§ 290ff–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 290ff–1. Requirements with respect to carrying
out purpose of grants
(a) Systems of comprehensive care
(1) In general
A funding agreement for a grant under section 290ff(a) of this title is that, with respect
to children with a serious emotional disturbance, the public entity involved will carry out
the purpose described in such section only
through establishing and operating 1 or more
systems of care for making each of the mental
health services specified in subsection (c) of
this section available to each child provided
access to the system. In providing for such a
system, the public entity may make grants to,
and enter into contracts with, public and nonprofit private entities.
(2) Structure of system
A funding agreement for a grant under section 290ff(a) of this title is that a system of
care under paragraph (1) will—
(A) be established in a community selected
by the public entity involved;
(B) consist of such public agencies and
nonprofit private entities in the community
as are necessary to ensure that each of the
services specified in subsection (c) of this
section is available to each child provided
access to the system;
(C) be established pursuant to agreements
that the public entity enters into with the
agencies and entities described in subparagraph (B);
(D) coordinate the provision of the services
of the system; and
(E) establish an office whose functions are
to serve as the location through which children are provided access to the system, to
coordinate the provision of services of the
system, and to provide information to the
public regarding the system.
(3) Collaboration of local public entities
A funding agreement for a grant under section 290ff(a) of this title is that, for purposes
of the establishment and operation of a system of care under paragraph (1), the public entity involved will seek collaboration among
all public agencies that provide human services in the community in which the system is
established, including but not limited to those
providing mental health services, educational
services, child welfare services, or juvenile
justice services.
(b) Limitation on age of children provided access
to system
A funding agreement for a grant under section
290ff(a) of this title is that a system of care
under subsection (a) of this section will not provide an individual with access to the system if
the individual is more than 21 years of age.
(c) Required mental health services of system
A funding agreement for a grant under section
290ff(a) of this title is that mental health services provided by a system of care under subsection (a) of this section will include, with respect to a serious emotional disturbance in a
child—

Page 720

(1) diagnostic and evaluation services;
(2) outpatient services provided in a clinic,
office, school or other appropriate location, including individual, group and family counseling services, professional consultation, and review and management of medications;
(3) emergency services, available 24-hours a
day, 7 days a week;
(4) intensive home-based services for children and their families when the child is at
imminent risk of out-of-home placement;
(5) intensive day-treatment services;
(6) respite care;
(7) therapeutic foster care services, and services in therapeutic foster family homes or individual therapeutic residential homes, and
groups homes caring for not more than 10 children; and
(8) assisting the child in making the transition from the services received as a child to
the services to be received as an adult.
(d) Required arrangements regarding other appropriate services
(1) In general
A funding agreement for a grant under section 290ff(a) of this title is that—
(A) a system of care under subsection (a)
of this section will enter into a memorandum of understanding with each of the providers specified in paragraph (2) in order to
facilitate the availability of the services of
the provider involved to each child provided
access to the system; and
(B) the grant under such section 290ff(a) of
this title, and the non-Federal contributions
made with respect to the grant, will not be
expended to pay the costs of providing such
non-mental health services to any individual.
(2) Specification of non-mental health services
The providers referred to in paragraph (1)
are providers of medical services other than
mental health services, providers of educational services, providers of vocational
counseling and vocational rehabilitation services, and providers of protection and advocacy
services with respect to mental health.
(3) Facilitation of services of certain programs
A funding agreement for a grant under section 290ff(a) of this title is that a system of
care under subsection (a) of this section will,
for purposes of paragraph (1), enter into a
memorandum of understanding regarding facilitation of—
(A) services available pursuant to title
XIX of the Social Security Act [42 U.S.C.
1396 et seq.], including services regarding
early periodic screening, diagnosis, and
treatment;
(B) services available under parts B and C
of the Individuals with Disabilities Education Act [20 U.S.C. 1411 et seq., 1431 et
seq.]; and
(C) services available under other appropriate programs, as identified by the Secretary.

Page 721

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) General provisions regarding services of system
(1) Case management services
A funding agreement for a grant under section 290ff(a) of this title is that a system of
care under subsection (a) of this section will
provide for the case management of each child
provided access to the system in order to ensure that—
(A) the services provided through the system to the child are coordinated and that
the need of each such child for the services
is periodically reassessed;
(B) information is provided to the family
of the child on the extent of progress being
made toward the objectives established for
the child under the plan of services implemented for the child pursuant to section
290ff–2 of this title; and
(C) the system provides assistance with respect to—
(i) establishing the eligibility of the
child, and the family of the child, for financial assistance and services under Federal, State, or local programs providing for
health services, mental health services,
educational services, social services, or
other services; and
(ii) seeking to ensure that the child receives appropriate services available under
such programs.
(2) Other provisions
A funding agreement for a grant under section 290ff(a) of this title is that a system of
care under subsection (a) of this section, in
providing the services of the system, will—
(A) provide the services of the system in
the cultural context that is most appropriate for the child and family involved;
(B) ensure that individuals providing such
services to the child can effectively communicate with the child and family in the most
direct manner;
(C) provide the services without discriminating against the child or the family of the
child on the basis of race, religion, national
origin, sex, disability, or age;
(D) seek to ensure that each child provided
access to the system of care remains in the
least restrictive, most normative environment that is clinically appropriate; and
(E) provide outreach services to inform individuals, as appropriate, of the services
available from the system, including identifying children with a serious emotional disturbance who are in the early stages of such
disturbance.
(3) Rule of construction
An agreement made under paragraph (2) may
not be construed—
(A) with respect to subparagraph (C) of
such paragraph—
(i) to prohibit a system of care under
subsection (a) of this section from requiring that, in housing provided by the grantee for purposes of residential treatment
services authorized under subsection (c) of
this section, males and females be segregated to the extent appropriate in the
treatment of the children involved; or

§ 290ff–1

(ii) to prohibit the system of care from
complying with the agreement made under
subsection (b) of this section; or
(B) with respect to subparagraph (D) of
such paragraph, to authorize the system of
care to expend the grant under section
290ff(a) of this title (or the non-Federal contributions made with respect to the grant)
to provide legal services or any service with
respect to which expenditures regarding the
grant are prohibited under subsection
(d)(1)(B) of this section.
(f) Restrictions on use of grant
A funding agreement for a grant under section
290ff(a) of this title is that the grant, and the
non-Federal contributions made with respect to
the grant, will not be expended—
(1) to purchase or improve real property (including the construction or renovation of facilities);
(2) to provide for room and board in residential programs serving 10 or fewer children;
(3) to provide for room and board or other
services or expenditures associated with care
of children in residential treatment centers
serving more than 10 children or in inpatient
hospital settings, except intensive home-based
services and other services provided on an ambulatory or outpatient basis; or
(4) to provide for the training of any individual, except training authorized in section
290ff–3(a)(2) of this title and training provided
through any appropriate course in continuing
education whose duration does not exceed 2
days.
(g) Waivers
The Secretary may waive one or more of the
requirements of subsection (c) of this section for
a public entity that is an Indian Tribe or tribal
organization, or American Samoa, Guam, the
Marshall Islands, the Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, or the United
States Virgin Islands if the Secretary determines, after peer review, that the system of care
is family-centered and uses the least restrictive
environment that is clinically appropriate.
(July 1, 1944, ch. 373, title V, § 562, as added Pub.
L. 102–321, title I, § 119, July 10, 1992, 106 Stat.
351; amended Pub. L. 106–310, div. B, title XXXI,
§ 3105(b), Oct. 17, 2000, 114 Stat. 1175; Pub. L.
108–446, title III, § 305(i)(4), Dec. 3, 2004, 118 Stat.
2806.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(d)(3)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
The Individuals with Disabilities Education Act, referred to in subsec. (d)(3)(B), is title VI of Pub. L.
91–230, Apr. 13, 1970, 84 Stat. 175, as amended. Parts B
and C of the Act are classified generally to subchapters
II (§ 1411 et seq.) and III (§ 1431 et seq.), respectively, of
chapter 33 of Title 20, Education. For complete classification of this Act to the Code, see section 1400 of Title
20 and Tables.
AMENDMENTS
2004—Subsec. (d)(3)(B). Pub. L. 108–446 substituted
‘‘and C’’ for ‘‘and H’’.

§ 290ff–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2000—Subsec. (g). Pub. L. 106–310 added subsec. (g).
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290ff–2. Individualized plan for services
(a) In general
A funding agreement for a grant under section
290ff(a) of this title is that a system of care
under section 290ff–1(a) of this title will develop
and carry out an individualized plan of services
for each child provided access to the system, and
that the plan will be developed and carried out
with the participation of the family of the child
and, unless clinically inappropriate, with the
participation of the child.
(b) Multidisciplinary team
A funding agreement for a grant under section
290ff(a) of this title is that the plan required in
subsection (a) of this section will be developed,
and reviewed and as appropriate revised not less
than once each year, by a multidisciplinary
team of appropriately qualified individuals who
provide services through the system, including
as appropriate mental health services, other
health services, educational services, social
services, and vocational counseling and rehabilitation; 1
(c) Coordination with services under Individuals
with Disabilities Education Act
A funding agreement for a grant under section
290ff(a) of this title is that, with respect to a
plan under subsection (a) of this section for a
child, the multidisciplinary team required in
subsection (b) of this section will—
(1) in developing, carrying out, reviewing,
and revising the plan consider any individualized education program in effect for the child
pursuant to part B of the Individuals with Disabilities Education Act [42 U.S.C. 1411 et seq.];
(2) ensure that the plan is consistent with
such individualized education program and
provides for coordinating services under the
plan with services under such program; and
(3) ensure that the memorandum of understanding
entered
into
under
section
290ff–1(d)(3)(B) of this title regarding such Act
[20 U.S.C. 1400 et seq.] includes provisions regarding compliance with this subsection.
(d) Contents of plan
A funding agreement for a grant under section
290ff(a) of this title is that the plan required in
subsection (a) of this section for a child will—
(1) identify and state the needs of the child
for the services available pursuant to section
290ff–1 of this title through the system;
(2) provide for each of such services that is
appropriate to the circumstances of the child,
including, except in the case of children who
are less than 14 years of age, the provision of
appropriate vocational counseling and rehabilitation, and transition services (as defined
in section 602 [20 U.S.C. 1401] of the Individuals
with Disabilities Education Act);
1 So

in original. The semicolon probably should be a period.

Page 722

(3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the objectives; and
(4) designate an individual to be responsible
for providing the case management required in
section 290ff–1(e)(1) of this title or certify that
case management services will be provided to
the child as part of the individualized education program of the child under the Individuals with Disabilities Education Act [20 U.S.C.
1400 et seq.].
(July 1, 1944, ch. 373, title V, § 563, as added Pub.
L. 102–321, title I, § 119, July 10, 1992, 106 Stat.
354; amended Pub. L. 108–446, title III, § 305(i)(5),
Dec. 3, 2004, 118 Stat. 2806.)
REFERENCES IN TEXT
The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1), (3) and (d)(4), is title VI of
Pub. L. 91–230, Apr. 13, 1970, 84 Stat. 175, as amended,
which is classified generally to chapter 33 (§ 1400 et seq.)
of Title 20, Education. Part B of the Act is classified
generally to subchapter II (§ 1411 et seq.) of chapter 33
of Title 20. For complete classification of this Act to
the Code, see section 1400 of Title 20 and Tables.
AMENDMENTS
2004—Subsec. (d)(2). Pub. L. 108–446 substituted ‘‘section 602’’ for ‘‘section 602(a)(19)’’.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290ff–3. Additional provisions
(a) Optional services
In addition to services described in subsection
(c) of section 290ff–1 of this title, a system of
care under subsection (a) of such section may, in
expending a grant under section 290ff(a) of this
title, provide for—
(1) preliminary assessments to determine
whether a child should be provided access to
the system;
(2) training in—
(A) the administration of the system;
(B) the provision of intensive home-based
services under paragraph (4) of section
290ff–1(c) of this title, intensive day treatment under paragraph (5) of such section,
and foster care or group homes under paragraph (7) of such section; and
(C) the development of individualized plans
for purposes of section 290ff–2 of this title;
(3) recreational activities for children provided access to the system; and
(4) such other services as may be appropriate
in providing for the comprehensive needs with
respect to mental health of children with a serious emotional disturbance.
(b) Comprehensive plan
The Secretary may make a grant under section 290ff(a) of this title only if, with respect to
the jurisdiction of the public entity involved,
the entity has submitted to the Secretary, and
has had approved by the Secretary, a plan for
the development of a jurisdiction-wide system of
care for community-based services for children

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

with a serious emotional disturbance that specifies the progress the public entity has made in
developing the jurisdiction-wide system, the extent of cooperation across agencies serving children in the establishment of the system, the
Federal and non-Federal resources currently
committed to the establishment of the system,
and the current gaps in community services and
the manner in which the grant under section
290ff(a) of this title will be expended to address
such gaps and establish local systems of care.
(c) Limitation on imposition of fees for services
A funding agreement for a grant under section
290ff(a) of this title is that, if a charge is imposed for the provision of services under the
grant, such charge—
(1) will be made according to a schedule of
charges that is made available to the public;
(2) will be adjusted to reflect the income of
the family of the child involved; and
(3) will not be imposed on any child whose
family has income and resources of equal to or
less than 100 percent of the official poverty
line, as established by the Director of the Office of Management and Budget and revised by
the Secretary in accordance with section
9902(2) of this title.
(d) Relationship to items and services under
other programs
A funding agreement for a grant under section
290ff(a) of this title is that the grant, and the
non-Federal contributions made with respect to
the grant, will not be expended to make payment for any item or service to the extent that
payment has been made, or can reasonably be
expected to be made, with respect to such item
or service—
(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services
on a prepaid basis.
(e) Limitation on administrative expenses
A funding agreement for a grant under section
290ff(a) of this title is that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
grant by the public entity involved.
(f) Reports to Secretary
A funding agreement for a grant under section
290ff(a) of this title is that the public entity involved will annually submit to the Secretary a
report on the activities of the entity under the
grant that includes a description of the number
of children provided access to systems of care
operated pursuant to the grant, the demographic
characteristics of the children, the types and
costs of services provided pursuant to the grant,
the availability and use of third-party reimbursements, estimates of the unmet need for
such services in the jurisdiction of the entity,
and the manner in which the grant has been expended toward the establishment of a jurisdiction-wide system of care for children with a serious emotional disturbance, and such other information as the Secretary may require with respect to the grant.
(g) Description of intended uses of grant
The Secretary may make a grant under section 290ff(a) of this title only if—

§ 290ff–4

(1) the public entity involved submits to the
Secretary a description of the purposes for
which the entity intends to expend the grant;
(2) the description identifies the populations,
areas, and localities in the jurisdiction of the
entity with a need for services under this section; and
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in
which the services and activities will be coordinated with any similar services or activities
of public or nonprofit entities.
(h) Requirement of application
The Secretary may make a grant under section 290ff(a) of this title only if an application
for the grant is submitted to the Secretary, the
application contains the description of intended
uses required in subsection (g) of this section,
and the application is in such form, is made in
such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(July 1, 1944, ch. 373, title V, § 564, as added Pub.
L. 102–321, title I, § 119, July 10, 1992, 106 Stat.
355.)
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 290ff–4. General provisions
(a) Duration of support
The period during which payments are made
to a public entity from a grant under section
290ff(a) of this title may not exceed 6 fiscal
years.
(b) Technical assistance
(1) In general
The Secretary shall, upon the request of a
public entity receiving a grant under section
290ff(a) of this title—
(A) provide technical assistance to the entity regarding the process of submitting to
the Secretary applications for grants under
section 290ff(a) of this title; and
(B) provide to the entity training and
technical assistance with respect to the
planning, development, and operation of systems of care pursuant to section 290ff–1 of
this title.
(2) Authority for grants and contracts
The Secretary may provide technical assistance under subsection (a) of this section directly or through grants to, or contracts with,
public and nonprofit private entities.
(c) Evaluations and reports by Secretary
(1) In general
The Secretary shall, directly or through
contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to section 290ff(a) of this
title. The evaluations shall assess the effectiveness of the systems of care operated pursu-

§ 290gg

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ant to such section, including longitudinal
studies of outcomes of services provided by
such systems, other studies regarding such
outcomes, the effect of activities under this
part on the utilization of hospital and other
institutional settings, the barriers to and
achievements resulting from interagency collaboration in providing community-based
services to children with a serious emotional
disturbance, and assessments by parents of the
effectiveness of the systems of care.
(2) Report to Congress
The Secretary shall, not later than 1 year
after the date on which amounts are first appropriated under subsection (c) of this section,
and annually thereafter, submit to the Congress a report summarizing evaluations carried out pursuant to paragraph (1) during the
preceding fiscal year and making such recommendations for administrative and legislative
initiatives with respect to this section as the
Secretary determines to be appropriate.
(d) Definitions
For purposes of this part:
(1) The term ‘‘child’’ means an individual
not more than 21 years of age.
(2) The term ‘‘family’’, with respect to a
child provided access to a system of care under
section 290ff–1(a) of this title, means—
(A) the legal guardian of the child; and
(B) as appropriate regarding mental health
services for the child, the parents of the
child (biological or adoptive, as the case
may be) and any foster parents of the child.
(3) The term ‘‘funding agreement’’, with respect to a grant under section 290ff(a) of this
title to a public entity, means that the Secretary may make such a grant only if the public entity makes the agreement involved.
(4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any
child who has a serious emotional disorder, a
serious behavioral disorder, or a serious mental disorder.
(e) Rule of construction
Nothing in this part shall be construed as limiting the rights of a child with a serious emotional disturbance under the Individuals with
Disabilities Education Act [20 U.S.C. 1400 et
seq.].
(f) Funding
(1) Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated
$100,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal
years 2002 and 2003.
(2) Limitation regarding technical assistance
Not more than 10 percent of the amounts appropriated under paragraph (1) for a fiscal year
may be expended for carrying out subsection
(b) of this section.
(July 1, 1944, ch. 373, title V, § 565, as added Pub.
L. 102–321, title I, § 119, July 10, 1992, 106 Stat.
356; amended Pub. L. 103–43, title XX, § 2017(2),
June 10, 1993, 107 Stat. 218; Pub. L. 106–310, div.

Page 724

B, title XXXI, § 3105(c), (d), Oct. 17, 2000, 114 Stat.
1175.)
REFERENCES IN TEXT
The Individuals with Disabilities Education Act, referred to in subsec. (e), is title VI of Pub. L. 91–230, Apr.
13, 1970, 84 Stat. 175, as amended, which is classified
generally to chapter 33 (§ 1400 et seq.) of Title 20, Education. For complete classification of this Act to the
Code, see section 1400 of Title 20 and Tables.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, § 3105(c), substituted
‘‘6 fiscal years’’ for ‘‘5 fiscal years’’.
Subsec. (f)(1). Pub. L. 106–310, § 3105(d), substituted
‘‘2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003’’ for ‘‘1993, and such sums
as may be necessary for fiscal year 1994’’.
1993—Subsec. (c)(1), (d), (f)(1). Pub. L. 103–43,
§ 2017(2)(A), (B), (C)(i), substituted ‘‘this part’’ for ‘‘this
subpart’’.
Subsec. (f)(2). Pub. L. 103–43, § 2017(2)(C)(ii), amended
heading and text of par. (2) generally. Prior to amendment, text read as follows: ‘‘Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall make available not less than $3,000,000 for
the purpose of carrying out subsection (b) of this section.’’
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

PART F—MODEL COMPREHENSIVE PROGRAM FOR
TREATMENT OF SUBSTANCE ABUSE
§ 290gg. Repealed. Pub. L. 106–310, div. B, title
XXXIII, § 3301(c)(4), Oct. 17, 2000, 114 Stat.
1209
Section, act July 1, 1944, ch. 373, title V, § 571, as
added Pub. L. 102–321, title III, § 301, July 10, 1992, 106
Stat. 417, related to demonstration program in national
capital area.

PART G—PROJECTS FOR CHILDREN AND
VIOLENCE
CODIFICATION
This part is comprised of part G of title V of act July
1, 1944. Another part G of title V of act July 1, 1944, is
classified to part J (§ 290kk et seq.) of this subchapter.

§ 290hh. Children and violence
(a) In general
The Secretary, in consultation with the Secretary of Education and the Attorney General,
shall carry out directly or through grants, contracts or cooperative agreements with public entities a program to assist local communities in
developing ways to assist children in dealing
with violence.
(b) Activities
Under the program under subsection (a) of this
section, the Secretary may—
(1) provide financial support to enable local
communities to implement programs to foster
the health and development of children;
(2) provide technical assistance to local communities with respect to the development of
programs described in paragraph (1);
(3) provide assistance to local communities
in the development of policies to address violence when and if it occurs;

Page 725

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) assist in the creation of community partnerships among law enforcement, education
systems and mental health and substance
abuse service systems; and
(5) establish mechanisms for children and
adolescents to report incidents of violence or
plans by other children or adolescents to commit violence.
(c) Requirements
An application for a grant, contract or cooperative agreement under subsection (a) of this section shall demonstrate that—
(1) the applicant will use amounts received
to create a partnership described in subsection
(b)(4) of this section to address issues of violence in schools;
(2) the activities carried out by the applicant will provide a comprehensive method for
addressing violence, that will include—
(A) security;
(B) educational reform;
(C) the review and updating of school policies;
(D) alcohol and drug abuse prevention and
early intervention services;
(E) mental health prevention and treatment services; and
(F) early childhood development and
psychosocial services; and
(3) the applicant will use amounts received
only for the services described in subparagraphs (D), (E), and (F) of paragraph (2).
(d) Geographical distribution
The Secretary shall ensure that grants, contracts or cooperative agreements under subsection (a) of this section will be distributed equitably among the regions of the country and
among urban and rural areas.
(e) Duration of awards
With respect to a grant, contract or cooperative agreement under subsection (a) of this section, the period during which payments under
such an award will be made to the recipient may
not exceed 5 years.
(f) Evaluation
The Secretary shall conduct an evaluation of
each project carried out under this section and
shall disseminate the results of such evaluations
to appropriate public and private entities.
(g) Information and education
The Secretary shall establish comprehensive
information and education programs to disseminate the findings of the knowledge development
and application under this section to the general
public and to health care professionals.
(h) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $100,000,000 for fiscal year
2001, and such sums as may be necessary for
each of fiscal years 2002 and 2003.
(July 1, 1944, ch. 373, title V, § 581, as added Pub.
L. 106–310, div. B, title XXXI, § 3101, Oct. 17, 2000,
114 Stat. 1168.)

§ 290hh–1

§ 290hh–1. Grants to address the problems of persons who experience violence related stress
(a) In general
The Secretary shall award grants, contracts or
cooperative agreements to public and nonprofit
private entities, as well as to Indian tribes and
tribal organizations, for the purpose of developing programs focusing on the behavioral and biological aspects of psychological trauma response and for developing knowledge with regard to evidence-based practices for treating
psychiatric disorders of children and youth resulting from witnessing or experiencing a traumatic event.
(b) Priorities
In awarding grants, contracts or cooperative
agreements under subsection (a) of this section
related to the development of knowledge on evidence-based practices for treating disorders associated with psychological trauma, the Secretary shall give priority to mental health agencies and programs that have established clinical
and basic research experience in the field of
trauma-related mental disorders.
(c) Geographical distribution
The Secretary shall ensure that grants, contracts or cooperative agreements under subsection (a) of this section with respect to centers of excellence are distributed equitably
among the regions of the country and among
urban and rural areas.
(d) Evaluation
The Secretary, as part of the application process, shall require that each applicant for a
grant, contract or cooperative agreement under
subsection (a) of this section submit a plan for
the rigorous evaluation of the activities funded
under the grant, contract or agreement, including both process and outcomes evaluation, and
the submission of an evaluation at the end of
the project period.
(e) Duration of awards
With respect to a grant, contract or cooperative agreement under subsection (a) of this section, the period during which payments under
such an award will be made to the recipient may
not exceed 5 years. Such grants, contracts or
agreements may be renewed.
(f) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $50,000,000 for fiscal year
2001, and such sums as may be necessary for
each of fiscal years 2003 through 2006.
(g) Short title
This section may be cited as the ‘‘Donald J.
Cohen National Child Traumatic Stress Initiative’’.
(July 1, 1944, ch. 373, title V, § 582, as added Pub.
L. 106–310, div. B, title XXXI, § 3101, Oct. 17, 2000,
114 Stat. 1169; amended Pub. L. 107–116, title II,
§ 218, Jan. 10, 2002, 115 Stat. 2201; Pub. L. 107–188,
title I, § 155, June 12, 2002, 116 Stat. 633.)

CODIFICATION

CODIFICATION

Another section 581 of act July 1, 1944, is classified to
section 290kk of this title.

Another section 582 of act July 1, 1944, is classified to
section 290kk–1 of this title.

§ 290ii

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2002—Subsec. (f). Pub. L. 107–188 substituted ‘‘2003
through 2006’’ for ‘‘2002 and 2003’’.
Subsec. (g). Pub. L. 107–116 added subsec. (g).

PART H—REQUIREMENT RELATING TO THE
RIGHTS OF RESIDENTS OF CERTAIN FACILITIES
§ 290ii. Requirement relating to the rights of residents of certain facilities
(a) In general
A public or private general hospital, nursing
facility, intermediate care facility, or other
health care facility, that receives support in any
form from any program supported in whole or in
part with funds appropriated to any Federal department or agency shall protect and promote
the rights of each resident of the facility, including the right to be free from physical or
mental abuse, corporal punishment, and any restraints or involuntary seclusions imposed for
purposes of discipline or convenience.
(b) Requirements
Restraints and seclusion may only be imposed
on a resident of a facility described in subsection (a) of this section if—
(1) the restraints or seclusion are imposed to
ensure the physical safety of the resident, a
staff member, or others; and
(2) the restraints or seclusion are imposed
only upon the written order of a physician, or
other licensed practitioner permitted by the
State and the facility to order such restraint
or seclusion, that specifies the duration and
circumstances under which the restraints are
to be used (except in emergency circumstances
specified by the Secretary until such an order
could reasonably be obtained).
(c) Current law
This part shall not be construed to affect or
impede any Federal or State law or regulations
that provide greater protections than this part
regarding seclusion and restraint.
(d) Definitions
In this section:
(1) Restraints
The term ‘‘restraints’’ means—
(A) any physical restraint that is a mechanical or personal restriction that immobilizes or reduces the ability of an individual
to move his or her arms, legs, or head freely,
not including devices, such as orthopedically
prescribed devices, surgical dressings or bandages, protective helmets, or any other
methods that involves the physical holding
of a resident for the purpose of conducting
routine physical examinations or tests or to
protect the resident from falling out of bed
or to permit the resident to participate in
activities without the risk of physical harm
to the resident (such term does not include
a physical escort); and
(B) a drug or medication that is used as a
restraint to control behavior or restrict the
resident’s freedom of movement that is not a
standard treatment for the resident’s medical or psychiatric condition.

Page 726

(2) Seclusion
The term ‘‘seclusion’’ means a behavior control technique involving locked isolation.
Such term does not include a time out.
(3) Physical escort
The term ‘‘physical escort’’ means the temporary touching or holding of the hand, wrist,
arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to
a safe location.
(4) Time out
The term ‘‘time out’’ means a behavior management technique that is part of an approved
treatment program and may involve the separation of the resident from the group, in a
non-locked setting, for the purpose of calming.
Time out is not seclusion.
(July 1, 1944, ch. 373, title V, § 591, as added Pub.
L. 106–310, div. B, title XXXII, § 3207, Oct. 17, 2000,
114 Stat. 1195.)
§ 290ii–1. Reporting requirement
(a) In general
Each facility to which the Protection and Advocacy for Mentally Ill Individuals Act of 1986 1
[42 U.S.C. 10801 et seq.] applies shall notify the
appropriate agency, as determined by the Secretary, of each death that occurs at each such
facility while a patient is restrained or in seclusion, of each death occurring within 24 hours
after the patient has been removed from restraints and seclusion, or where it is reasonable
to assume that a patient’s death is a result of
such seclusion or restraint. A notification under
this section shall include the name of the resident and shall be provided not later than 7 days
after the date of the death of the individual involved.
(b) Facility
In this section, the term ‘‘facility’’ has the
meaning given the term ‘‘facilities’’ in section
102(3) of the Protection and Advocacy for Mentally Ill Individuals Act of 1986 1 (42 U.S.C.
10802(3)).
(July 1, 1944, ch. 373, title V, § 592, as added Pub.
L. 106–310, div. B, title XXXII, § 3207, Oct. 17, 2000,
114 Stat. 1196.)
REFERENCES IN TEXT
The Protection and Advocacy for Mentally Ill Individuals Act of 1986, referred to in text, was Pub. L.
99–319, May 23, 1986, 100 Stat. 478, as amended. Pub. L.
99–319 was renamed the Protection and Advocacy for Individuals with Mental Illness Act by Pub. L. 106–310,
div. B, title XXXII, § 3206(a), Oct. 17, 2000, 114 Stat. 1193,
and is classified generally to chapter 114 (§ 10801 et seq.)
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section
10801 of this title and Tables.

§ 290ii–2. Regulations and enforcement
(a) Training
Not later than 1 year after October 17, 2000,
the Secretary, after consultation with appropriate State and local protection and advocacy
1 See

References in Text note below.

Page 727

TITLE 42—THE PUBLIC HEALTH AND WELFARE

organizations, physicians, facilities, and other
health care professionals and patients, shall promulgate regulations that require facilities to
which the Protection and Advocacy for Mentally
Ill Individuals Act of 1986 1 (42 U.S.C. 10801 et
seq.) applies, to meet the requirements of subsection (b) of this section.
(b) Requirements
The regulations promulgated under subsection
(a) of this section shall require that—
(1) facilities described in subsection (a) of
this section ensure that there is an adequate
number of qualified professional and supportive staff to evaluate patients, formulate written individualized, comprehensive treatment
plans, and to provide active treatment measures;
(2) appropriate training be provided for the
staff of such facilities in the use of restraints
and any alternatives to the use of restraints;
and
(3) such facilities provide complete and accurate notification of deaths, as required under
section 290ii–1(a) of this title.
(c) Enforcement
A facility to which this part applies that fails
to comply with any requirement of this part, including a failure to provide appropriate training, shall not be eligible for participation in any
program supported in whole or in part by funds
appropriated to any Federal department or
agency.
(July 1, 1944, ch. 373, title V, § 593, as added Pub.
L. 106–310, div. B, title XXXII, § 3207, Oct. 17, 2000,
114 Stat. 1196.)
REFERENCES IN TEXT
The Protection and Advocacy for Mentally Ill Individuals Act of 1986, referred to in subsec. (a), was Pub.
L. 99–319, May 23, 1986, 100 Stat. 478, as amended. Pub.
L. 99–319 was renamed the Protection and Advocacy for
Individuals with Mental Illness Act by Pub. L. 106–310,
div. B, title XXXII, § 3206(a), Oct. 17, 2000, 114 Stat. 1193,
and is classified generally to chapter 114 (§ 10801 et seq.)
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section
10801 of this title and Tables.

PART I—REQUIREMENT RELATING TO THE RIGHTS
OF RESIDENTS OF CERTAIN NON-MEDICAL, COMMUNITY-BASED FACILITIES FOR CHILDREN AND
YOUTH
§ 290jj. Requirement relating to the rights of residents of certain non-medical, communitybased facilities for children and youth
(a) Protection of rights
(1) In general
A public or private non-medical, community-based facility for children and youth (as
defined in regulations to be promulgated by
the Secretary) that receives support in any
form from any program supported in whole or
in part with funds appropriated under this
chapter shall protect and promote the rights
of each resident of the facility, including the
right to be free from physical or mental abuse,
1 See

References in Text note below.

§ 290jj

corporal punishment, and any restraints or involuntary seclusions imposed for purposes of
discipline or convenience.
(2) Nonapplicability
Notwithstanding this part, a facility that
provides inpatient psychiatric treatment services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and
(h) of section 1905 of the Social Security Act
[42 U.S.C. 1396d], shall comply with the requirements of part H of this subchapter.
(3) Applicability of Medicaid provisions
A non-medical, community-based facility for
children and youth funded under the Medicaid
program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] shall continue
to meet all existing requirements for participation in such program that are not affected
by this part.
(b) Requirements
(1) In general
Physical restraints and seclusion may only
be imposed on a resident of a facility described
in subsection (a) of this section if—
(A) the restraints or seclusion are imposed
only in emergency circumstances and only
to ensure the immediate physical safety of
the resident, a staff member, or others and
less restrictive interventions have been determined to be ineffective; and
(B) the restraints or seclusion are imposed
only by an individual trained and certified,
by a State-recognized body (as defined in
regulation promulgated by the Secretary)
and pursuant to a process determined appropriate by the State and approved by the Secretary, in the prevention and use of physical
restraint and seclusion, including the needs
and behaviors of the population served, relationship building, alternatives to restraint
and seclusion, de-escalation methods, avoiding power struggles, thresholds for restraints and seclusion, the physiological and
psychological impact of restraint and seclusion, monitoring physical signs of distress
and obtaining medical assistance, legal issues, position asphyxia, escape and evasion
techniques, time limits, the process for obtaining approval for continued restraints,
procedures to address problematic restraints, documentation, processing with
children, and follow-up with staff, and investigation of injuries and complaints.
(2) Interim procedures relating to training and
certification
(A) In general
Until such time as the State develops a
process to assure the proper training and
certification of facility personnel in the
skills and competencies referred 1 in paragraph (1)(B), the facility involved shall develop and implement an interim procedure
that meets the requirements of subparagraph (B).
(B) Requirements
A procedure developed under subparagraph
(A) shall—
1 So

in original. Probably should be followed by ‘‘to’’.

§ 290jj–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) ensure that a supervisory or senior
staff person with training in restraint and
seclusion who is competent to conduct a
face-to-face assessment (as defined in regulations promulgated by the Secretary),
will assess the mental and physical wellbeing of the child or youth being restrained or secluded and assure that the
restraint or seclusion is being done in a
safe manner;
(ii) ensure that the assessment required
under clause (i) take place as soon as practicable, but in no case later than 1 hour
after the initiation of the restraint or seclusion; and
(iii) ensure that the supervisory or senior staff person continues to monitor the
situation for the duration of the restraint
and seclusion.
(3) Limitations
(A) In general
The use of a drug or medication that is
used as a restraint to control behavior or restrict the resident’s freedom of movement
that is not a standard treatment for the resident’s medical or psychiatric condition in
nonmedical community-based facilities for
children and youth described in subsection
(a)(1) of this section is prohibited.
(B) Prohibition
The use of mechanical restraints in nonmedical, community-based facilities for children and youth described in subsection (a)(1)
of this section is prohibited.
(C) Limitation
A non-medical, community-based facility
for children and youth described in subsection (a)(1) of this section may only use seclusion when a staff member is continuously
face-to-face monitoring the resident and
when strong licensing or accreditation and
internal controls are in place.
(c) Rule of construction
(1) In general
Nothing in this section shall be construed as
prohibiting the use of restraints for medical
immobilization, adaptive support, or medical
protection.
(2) Current law
This part shall not be construed to affect or
impede any Federal or State law or regulations that provide greater protections than
this part regarding seclusion and restraint.
(d) Definitions
In this section:
(1) Mechanical restraint
The term ‘‘mechanical restraint’’ means the
use of devices as a means of restricting a resident’s freedom of movement.
(2) Physical escort
The term ‘‘physical escort’’ means the temporary touching or holding of the hand, wrist,
arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to
a safe location.

Page 728

(3) Physical restraint
The term ‘‘physical restraint’’ means a personal restriction that immobilizes or reduces
the ability of an individual to move his or her
arms, legs, or head freely. Such term does not
include a physical escort.
(4) Seclusion
The term ‘‘seclusion’’ means a behavior control technique involving locked isolation.
Such term does not include a time out.
(5) Time out
The term ‘‘time out’’ means a behavior management technique that is part of an approved
treatment program and may involve the separation of the resident from the group, in a
non-locked setting, for the purpose of calming.
Time out is not seclusion.
(July 1, 1944, ch. 373, title V, § 595, as added Pub.
L. 106–310, div. B, title XXXII, § 3208, Oct. 17, 2000,
114 Stat. 1197.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (a)(3),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Title XIX of the Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.

§ 290jj–1. Reporting requirement
Each facility to which this part applies shall
notify the appropriate State licensing or regulatory agency, as determined by the Secretary—
(1) of each death that occurs at each such facility. A notification under this section shall
include the name of the resident and shall be
provided not later than 24 hours after the time
of the individuals 1 death; and
(2) of the use of seclusion or restraints in accordance with regulations promulgated by the
Secretary, in consultation with the States.
(July 1, 1944, ch. 373, title V, § 595A, as added
Pub. L. 106–310, div. B, title XXXII, § 3208, Oct.
17, 2000, 114 Stat. 1199.)
§ 290jj–2. Regulations and enforcement
(a) Training
Not later than 6 months after October 17, 2000,
the Secretary, after consultation with appropriate State, local, public and private protection
and advocacy organizations, health care professionals, social workers, facilities, and patients,
shall promulgate regulations that—
(1) require States that license non-medical,
community-based residential facilities for
children and youth to develop licensing rules
and monitoring requirements concerning behavior management practice that will ensure
compliance with Federal regulations and to
meet the requirements of subsection (b) of this
section;
(2) require States to develop and implement
such licensing rules and monitoring requirements within 1 year after the promulgation of
the regulations referred to in the matter preceding paragraph (1); and
1 So

in original. Probably should be ‘‘individual’s’’.

Page 729

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) support the development of national
guidelines and standards on the quality, quantity, orientation and training, required under
this part, as well as the certification or licensure of those staff responsible for the implementation of behavioral intervention concepts
and techniques.
(b) Requirements
The regulations promulgated under subsection
(a) of this section shall require—
(1) that facilities described in subsection (a)
of this section ensure that there is an adequate number of qualified professional and
supportive staff to evaluate residents, formulate written individualized, comprehensive
treatment plans, and to provide active treatment measures;
(2) the provision of appropriate training and
certification of the staff of such facilities in
the prevention and use of physical restraint
and seclusion, including the needs and behaviors of the population served, relationship
building, alternatives to restraint, de-escalation methods, avoiding power struggles,
thresholds for restraints, the physiological impact of restraint and seclusion, monitoring
physical signs of distress and obtaining medical assistance, legal issues, position asphyxia,
escape and evasion techniques, time limits for
the use of restraint and seclusion, the process
for obtaining approval for continued restraints
and seclusion, procedures to address problematic restraints, documentation, processing
with children, and follow-up with staff, and investigation of injuries and complaints; and
(3) that such facilities provide complete and
accurate notification of deaths, as required
under section 290jj–1(1) of this title.
(c) Enforcement
A State to which this part applies that fails to
comply with any requirement of this part, including a failure to provide appropriate training
and certification, shall not be eligible for participation in any program supported in whole or
in part by funds appropriated under this chapter.
(July 1, 1944, ch. 373, title V, § 595B, as added
Pub. L. 106–310, div. B, title XXXII, § 3208, Oct.
17, 2000, 114 Stat. 1199.)
PART J—SERVICES PROVIDED THROUGH
RELIGIOUS ORGANIZATIONS
CODIFICATION
This part was, in the original, part G of title V of act
July 1, 1944, and has been redesignated as part J for
purposes of codification. Another part G of title V of
act July 1, 1944, is classified to part G (§ 290hh et seq.)
of this subchapter.

§ 290kk. Applicability to designated programs
(a) Designated programs
Subject to subsection (b) of this section, this
part applies to discretionary and formula grant
programs administered by the Substance Abuse
and Mental Health Services Administration that
make awards of financial assistance to public or
private entities for the purpose of carrying out
activities to prevent or treat substance abuse

§ 290kk–1

(in this part referred to as a ‘‘designated program’’). Designated programs include the program under subpart II of part B of subchapter
XVII of this chapter (relating to formula grants
to the States).
(b) Limitation
This part does not apply to any award of financial assistance under a designated program
for a purpose other than the purpose specified in
subsection (a) of this section.
(c) Definitions
For purposes of this part (and subject to subsection (b) of this section):
(1) The term ‘‘designated program’’ has the
meaning given such term in subsection (a) of
this section.
(2) The term ‘‘financial assistance’’ means a
grant, cooperative agreement, or contract.
(3) The term ‘‘program beneficiary’’ means
an individual who receives program services.
(4) The term ‘‘program participant’’ means a
public or private entity that has received financial assistance under a designated program.
(5) The term ‘‘program services’’ means
treatment for substance abuse, or preventive
services regarding such abuse, provided pursuant to an award of financial assistance under
a designated program.
(6) The term ‘‘religious organization’’ means
a nonprofit religious organization.
(July 1, 1944, ch. 373, title V, § 581, as added Pub.
L. 106–554, § 1(a)(7) [title I, § 144], Dec. 21, 2000, 114
Stat. 2763, 2763A–619.)
CODIFICATION
Another section 581 of act July 1, 1944, is classified to
section 290hh of this title.

§ 290kk–1. Religious organizations as program
participants
(a) In general
Notwithstanding any other provision of law, a
religious organization, on the same basis as any
other nonprofit private provider—
(1) may receive financial assistance under a
designated program; and
(2) may be a provider of services under a designated program.
(b) Religious organizations
The purpose of this section is to allow religious organizations to be program participants
on the same basis as any other nonprofit private
provider without impairing the religious character of such organizations, and without diminishing the religious freedom of program beneficiaries.
(c) Nondiscrimination against religious organizations
(1) Eligibility as program participants
Religious organizations are eligible to be
program participants on the same basis as any
other nonprofit private organization as long as
the programs are implemented consistent with
the Establishment Clause and Free Exercise
Clause of the First Amendment to the United
States Constitution. Nothing in this chapter

§ 290kk–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall be construed to restrict the ability of the
Federal Government, or a State or local government receiving funds under such programs,
to apply to religious organizations the same
eligibility conditions in designated programs
as are applied to any other nonprofit private
organization.
(2) Nondiscrimination
Neither the Federal Government nor a State
or local government receiving funds under designated programs shall discriminate against
an organization that is or applies to be a program participant on the basis that the organization has a religious character.
(d) Religious character and freedom
(1) Religious organizations
Except as provided in this section, any religious organization that is a program participant shall retain its independence from Federal, State, and local government, including
such organization’s control over the definition, development, practice, and expression of
its religious beliefs.
(2) Additional safeguards
Neither the Federal Government nor a State
shall require a religious organization to—
(A) alter its form of internal governance;
or
(B) remove religious art, icons, scripture,
or other symbols,
in order to be a program participant.
(e) Employment practices
Nothing in this section shall be construed to
modify or affect the provisions of any other Federal or State law or regulation that relates to
discrimination in employment. A religious organization’s exemption provided under section
2000e–1 of this title regarding employment practices shall not be affected by its participation
in, or receipt of funds from, a designated program.
(f) Rights of program beneficiaries
(1) In general
If an individual who is a program beneficiary
or a prospective program beneficiary objects
to the religious character of a program participant, within a reasonable period of time
after the date of such objection such program
participant shall refer such individual to, and
the appropriate Federal, State, or local government that administers a designated program or is a program participant shall provide
to such individual (if otherwise eligible for
such services), program services that—
(A) are from an alternative provider that
is accessible to, and has the capacity to provide such services to, such individual; and
(B) have a value that is not less than the
value of the services that the individual
would have received from the program participant to which the individual had such objection.
Upon referring a program beneficiary to an alternative provider, the program participant
shall notify the appropriate Federal, State, or
local government agency that administers the
program of such referral.

Page 730

(2) Notices
Program participants, public agencies that
refer individuals to designated programs, and
the appropriate Federal, State, or local governments that administer designated programs or are program participants shall ensure that notice is provided to program beneficiaries or prospective program beneficiaries
of their rights under this section.
(3) Additional requirements
A program participant making a referral
pursuant to paragraph (1) shall—
(A) prior to making such referral, consider
any list that the State or local government
makes available of entities in the geographic
area that provide program services; and
(B) ensure that the individual makes contact with the alternative provider to which
the individual is referred.
(4) Nondiscrimination
A religious organization that is a program
participant shall not in providing program
services or engaging in outreach activities
under
designated
programs
discriminate
against a program beneficiary or prospective
program beneficiary on the basis of religion or
religious belief.
(g) Fiscal accountability
(1) In general
Except as provided in paragraph (2), any religious organization that is a program participant shall be subject to the same regulations
as other recipients of awards of Federal financial assistance to account, in accordance with
generally accepted auditing principles, for the
use of the funds provided under such awards.
(2) Limited audit
With respect to the award involved, a religious organization that is a program participant shall segregate Federal amounts provided
under award into a separate account from nonFederal funds. Only the award funds shall be
subject to audit by the government.
(h) Compliance
With respect to compliance with this section
by an agency, a religious organization may obtain judicial review of agency action in accordance with chapter 7 of title 5.
(July 1, 1944, ch. 373, title V, § 582, as added Pub.
L. 106–554, § 1(a)(7) [title I, § 144], Dec. 21, 2000, 114
Stat. 2763, 2763A–620.)
CODIFICATION
Another section 582 of act July 1, 1944, is classified to
section 290hh–1 of this title.

§ 290kk–2. Limitations on use of funds for certain
purposes
No funds provided under a designated program
shall be expended for sectarian worship, instruction, or proselytization.
(July 1, 1944, ch. 373, title V, § 583, as added Pub.
L. 106–554, § 1(a)(7) [title I, § 144], Dec. 21, 2000, 114
Stat. 2763, 2763A–622.)

Page 731

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 290kk–3. Educational requirements for personnel in drug treatment programs
(a) Findings
The Congress finds that—
(1) establishing unduly rigid or uniform educational qualification for counselors and other
personnel in drug treatment programs may
undermine the effectiveness of such programs;
and
(2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug treatment
services.
(b) Nondiscrimination
In determining whether personnel of a program participant that has a record of successful
drug treatment for the preceding three years
have satisfied State or local requirements for
education and training, a State or local government shall not discriminate against education
and training provided to such personnel by a religious organization, so long as such education
and training includes basic content substantially equivalent to the content provided by
nonreligious organizations that the State or
local government would credit for purposes of
determining whether the relevant requirements
have been satisfied.
(July 1, 1944, ch. 373, title V, § 584, as added Pub.
L. 106–554, § 1(a)(7) [title I, § 144], Dec. 21, 2000, 114
Stat. 2763, 2763A–622.)
SUBCHAPTER
IV—CONSTRUCTION
MODERNIZATION OF HOSPITALS
OTHER MEDICAL FACILITIES

AND
AND

§ 291. Congressional declaration of purpose
The purpose of this subchapter is—
(a) to assist the several States in the carrying out of their programs for the construction
and modernization of such public or other nonprofit community hospitals and other medical
facilities as may be necessary, in conjunction
with existing facilities, to furnish adequate
hospital, clinic, or similar services to all their
people;
(b) to stimulate the development of new or
improved types of physical facilities for medical, diagnostic, preventive, treatment, or rehabilitative services; and
(c) to promote research, experiments, and
demonstrations relating to the effective development and utilization of hospital, clinic, or
similar services, facilities, and resources, and
to promote the coordination of such research,
experiments, and demonstrations and the useful application of their results.
(July 1, 1944, ch. 373, title VI, § 600, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 447.)
PRIOR PROVISIONS
A prior section 291, act July 1, 1944, ch. 373, title VI,
§ 601, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended Oct. 25, 1949, ch. 722, § 6, 63 Stat. 900; July 12,
1954, ch. 471, § 4(a), 68 Stat. 464, related to subject matter similar to this section, prior to the general amendment of this subchapter by Pub. L. 88–443.
Provisions similar to those comprising this section
were contained in former section 291o, act July 1, 1944,

§ 291a

ch. 373, title VI, § 641, as added July 12, 1954, ch. 471, § 2,
68 Stat. 461, prior to the general amendment of this
subchapter by Pub. L. 88–443.
EFFECTIVE DATE
Section 3(b) of Pub. L. 88–443, as amended by Pub. L.
91–296, title I, § 120, June 30, 1970, 84 Stat. 343, provided
that: ‘‘The amendment made by subsection (a) [enacting this section and sections 291a to 291j, 291k to 291m,
291n, and 291o of this title] shall become effective upon
the date of enactment of this Act [Aug. 18, 1964], except
that—
‘‘(1) all applications approved by the Surgeon General under title VI of the Public Health Service Act
[this subchapter] prior to such date, and allotments
of sums appropriated prior to such date, shall be governed by the provisions of such title VI in effect prior
to such date;
‘‘(2) allotment percentages promulgated by the Surgeon General under such title VI during 1962 shall
continue to be effective for purposes of such title as
amended by this Act for the fiscal year ending June
30, 1965;
‘‘(3) the terms of members of the Federal Hospital
Council who are serving on such Council prior to such
date shall expire on the date they would have expired
had this Act not been enacted;
‘‘(4) the provisions of the fourth sentence of section
636(a) of the Public Health Service Act [former section 291n of this title], as in effect prior to the enactment of this Act, shall apply in lieu of the fourth sentence of section 624(a) of the Public Health Service
Act [section 291n(a) of this title], as amended by this
Act, in the case of any project for construction of a
facility or for acquisition of equipment with respect
to which a grant for any part thereof or for planning
such construction or equipment was made prior to
the enactment of this Act;
‘‘(5) no application with respect to a project for
modernization of any facility in any State may be approved by the Surgeon General, for purposes of receiving funds from an allotment under section
602(a)(2) of the Public Health Service Act, as amended
by this Act [section 291b(a)(2) of this title], before
July 1, 1965, or before such State has had a State plan
approved by the Surgeon General as meeting the requirements
of
section
604(a)(4)(E)
[section
291d(a)(4)(E) of this title] as well as the other requirements of section 604 of such Act as so amended [section 291d of this title];
‘‘(6) the provisions of clause (b) of section 609 of the
Public Health Service Act [section 291i of this title],
as amended by this Act, shall apply with respect to
any project whether it was approved, and whether the
event specified in such clause occurred, before, on, or
after the date of enactment of this Act [June 30, 1970],
except that it shall not apply in the case of any
project with respect to which recovery under title VI
of such Act [this subchapter] has been made prior to
the enactment of this paragraph.’’

PART A—GRANTS AND LOANS FOR CONSTRUCTION
AND MODERNIZATION OF HOSPITALS AND OTHER
MEDICAL FACILITIES
§ 291a. Authorization of appropriations
In order to assist the States in carrying out
the purposes of section 291 of this title, there are
authorized to be appropriated—
(a) for the fiscal year ending June 30, 1974—
(1) $20,800,000 for grants for the construction of public or other nonprofit facilities
for long-term care;
(2) $70,000,000 for grants for the construction of public or other nonprofit outpatient
facilities;
(3) $15,000,000 for grants for the construction of public or other nonprofit rehabilitation facilities;

§ 291b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) for grants for the construction of public
or other nonprofit hospitals and public health
centers, $150,000,000 for the fiscal year ending
June 30, 1965, $160,000,000 for the fiscal year
ending June 30, 1966, $170,000,000 for the fiscal
year ending June 30, 1967, $180,000,000 each for
the next two fiscal years, $195,000,000 for the
fiscal year ending June 30, 1970, $147,500,000 for
the fiscal year ending June 30, 1971, $152,500,000
for the fiscal year ending June 30, 1972,
$157,500,000 for the fiscal year ending June 30,
1973, and $41,400,000 for the fiscal year ending
June 30, 1974; and
(c) for grants for modernization of the facilities referred to in paragraphs (a) and (b),
$65,000,000 for the fiscal year ending June 30,
1971, $80,000,000 for the fiscal year ending June
30, 1972, $90,000,000 for the fiscal year ending
June 30, 1973, and $50,000,000 for the fiscal year
ending June 30, 1974.
(July 1, 1944, ch. 373, title VI, § 601, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 448; amended Pub. L. 90–574, title IV, § 402(a), Oct. 15, 1968,
82 Stat. 1011; Pub. L. 91–296, title I, §§ 101(a),
102(a), 116(a), June 30, 1970, 84 Stat. 337, 341; Pub.
L. 93–45, title I, § 108(a), June 18, 1973, 87 Stat. 92.)
PRIOR PROVISIONS
A prior section 291a, act July 1, 1944, ch. 373, title VI,
§ 611, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041, authorized appropriations for surveys and planning, prior
to the general amendment of this subchapter by Pub.
L. 88–443.
A prior section 291d, act July 1, 1944, ch. 373, title VI,
§ 621, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended Oct. 25, 1949, ch. 722, § 2(a), 63 Stat. 897; July
27, 1953, ch. 243, 67 Stat. 196; Aug. 2, 1956, ch. 871, title
IV, § 401, 70 Stat. 929; Aug. 14, 1958, Pub. L. 85–664, § 1(a),
72 Stat. 616, related to subject matter similar to this
section, prior to the general amendment of this subchapter by Pub. L. 88–443.
A prior section 291p, act July 1, 1944, ch. 373, title VI,
§ 646, as added July 12, 1954, ch. 471, § 2, 68 Stat. 461, related to subject matter similar to this section, prior to
the general amendment of this subchapter by Pub. L.
88–443.
A prior section 291s, act July 1, 1944, ch. 373, title VI,
§ 651, as added July 12, 1954, ch. 471, § 3, 68 Stat. 462;
amended Aug. 2, 1956, ch. 871, title IV, § 402, 70 Stat. 929;
Aug. 14, 1958, Pub. L. 85–664, § 1(b), 72 Stat. 616; Oct. 5,
1961, Pub. L. 87–395, § 3(a), 75 Stat. 825, related to subject
matter similar to this section, prior to the general
amendment of this subchapter by Pub. L. 88–443.
AMENDMENTS
1973—Subsec. (a). Pub. L. 93–45, § 108(a)(1), substituted
introductory text reading ‘‘fiscal year ending June 30,
1974’’ for ‘‘fiscal year ending June 30, 1965, and each of
the next eight fiscal years’’ and in cl. (1) ‘‘$20,800,000’’
for ‘‘$85,000,000’’.
Subsec. (b). Pub. L. 93–45, § 108(a)(2), authorized appropriations of $41,400,000 for fiscal year ending June 30,
1974.
Subsec. (c). Pub. L. 93–45, § 108(a)(3), authorized appropriations of $50,000,000 for fiscal year ending June 30,
1974.
1970—Par. (a). Pub. L. 91–296, §§ 101(a)(1), (2), 116(a),
substituted ‘‘outpatient facilities’’ for ‘‘diagnostic or
treatment centers’’ in enumeration of facilities eligible
for construction grants, extended through fiscal year
ending June 30, 1973, authority to appropriate funds for
construction grants, increased from $70,000,000 to
$85,000,000 annual authority to make grants for public
or other nonprofit facilities for long-term care, from
$20,000,000 to $70,000,000 authority for public or other
nonprofit outpatient facilities, and from $10,000,000 to

Page 732

$15,000,000 authority for public or other nonprofit rehabilitation facilities.
Par. (b). Pub. L. 91–296, §§ 101(a)(3), 102(a)(1), struck
out provisions authorizing grants for modernization of
facilities and inserted provisions authorizing appropriation of $147,500,000 for fiscal year ending June 30,
1971, $152,500,000 for fiscal year ending June 30, 1972, and
$157,500,000 for fiscal year ending June 30, 1973, for
grants for construction of public or other nonprofit
hospitals and public health centers
Par. (c). Pub. L. 91–296, § 102(a)(2), added par. (c).
1968—Par. (a). Pub. L. 90–574, § 402(a)(1), substituted
‘‘next five’’ for ‘‘next four’’.
Par. (b). Pub. L. 90–574, § 402(a)(2), authorized appropriation of $195,000,000 for fiscal year ending June 30,
1970.
EFFECTIVE DATE OF 1970 AMENDMENT
Section 101(b) of Pub. L. 91–296 provided that: ‘‘The
amendments made by subsection (a) [amending this
section] shall take effect with respect to appropriations
made under such section 601 [this section] for fiscal
years beginning after June 30, 1970.’’
Section 102(a) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to appropriations made under this section for fiscal years beginning after June 30, 1970.

§ 291b. State allotments
(a) Computation for individual States; formulas
for both new construction and modernization
(1) Each State shall be entitled for each fiscal
year to an allotment bearing the same ratio to
the sums appropriated for such year pursuant to
subparagraphs (1), (2), and (3), respectively, of
section 291a(a) of this title, and to an allotment
bearing the same ratio to the sums appropriated
for such year pursuant to section 291a(b) of this
title, as the product of—
(A) the population of such State, and
(B) the square of its allotment percentage,
bears to the sum of the corresponding products
for all of the States.
(2) For each fiscal year, the Secretary shall, in
accordance with regulations, make allotments
among the States, from the sums appropriated
for such year under section 291a(c) of this title,
on the basis of the population, the financial
need, and the extent of the need for modernization of the facilities referred to in paragraphs
(a) and (b) of section 291a of this title, of the respective States.
(b) Minimum allotments
(1) The allotment to any State under subsection (a) of this section for any fiscal year
which is less than—
(A) $50,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or Guam and $100,000 for any other
State, in the case of an allotment for grants
for the construction of public or other nonprofit rehabilitation facilities,
(B) $100,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or Guam and $200,000 for any other
State in the case of an allotment for grants for
the construction of public or other nonprofit
outpatient facilities,
(C) $200,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or Guam and $300,000 for any other

Page 733

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State in the case of an allotment for grants for
the construction of public or other nonprofit
facilities for long-term care or for the construction of public or other nonprofit hospitals and public health centers, or for the
modernization of facilities referred to in paragraph (a) or (b) of section 291a of this title, or
(D) $200,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or Guam and $300,000 for any other
State in the case of an allotment for grants for
the modernization of facilities referred to in
paragraphs (a) and (b) of section 291a of this
title,
shall be increased to that amount, the total of
the increases thereby required being derived by
proportionately reducing the allotment from appropriations under such subparagraph or paragraph to each of the remaining States under
subsection (a) of this section, but with such adjustments as may be necessary to prevent the
allotment of any of such remaining States from
appropriations under such subparagraph or paragraph from being thereby reduced to less than
that amount.
(2) An allotment of the Virgin Islands, American Samoa, the Trust Territory of the Pacific
Islands, or Guam for any fiscal year may be increased as provided in paragraph (1) only to the
extent it satisfies the Surgeon General, at such
time prior to the beginning of such year as the
Surgeon General may designate, that such increase will be used for payments under and in
accordance with the provisions of this part.
(c) Allotment percentages; definitions; determination
For the purposes of this part—
(1) The ‘‘allotment percentage’’ for any State
shall be 100 per centum less that percentage
which bears the same ratio to 50 per centum as
the per capita income of such State bears to the
per capita income of the United States, except
that (A) the allotment percentage shall in no
case be more than 75 per centum or less than
331⁄3 per centum, and (B) the allotment percentage for the Commonwealth of Puerto Rico,
Guam, American Samoa, the Trust Territory of
the Pacific Islands, and the Virgin Islands shall
be 75 per centum.
(2) The allotment percentages shall be determined by the Surgeon General between July 1
and September 30 of each even-numbered year,
on the basis of the average of the per capita incomes of each of the States and of the United
States for the three most recent consecutive
years for which satisfactory data are available
from the Department of Commerce, and the
States shall be notified promptly thereof. Such
determination shall be conclusive for each of the
two fiscal years in the period beginning July 1
next succeeding such determination.
(3) The population of the several States shall
be determined on the basis of the latest figures
certified by the Department of Commerce.
(4) The term ‘‘United States’’ means (but only
for purposes of paragraphs (1) and (2)) the fifty
States and the District of Columbia.
(d) Availability of allotments in subsequent years
(1) Any sum allotted to a State, other than the
Virgin Islands, American Samoa, the Trust Ter-

§ 291b

ritory of the Pacific Islands, and Guam for a fiscal year under this section and remaining unobligated at the end of such year shall remain
available to such State, for the purpose for
which made, for the next two fiscal years (and
for such years only), in addition to the sums allotted to such State for such purposes for such
next two fiscal years.
(2) Any sum allotted to the Virgin Islands,
American Samoa, the Trust Territory of the Pacific Islands, or Guam for a fiscal year under
this section and remaining unobligated at the
end of such year shall remain available to it, for
the purpose for which made, for the next two fiscal years (and for such years only), in addition
to the sums allotted to it for such purpose for
each of such next two fiscal years.
(e) Transfer of allotments
(1) Upon the request of any State that a specified portion of any allotment of such State
under subsection (a) of this section for any fiscal
year be added to any other allotment or allotments of such State under such subsection for
such year, the Secretary shall promptly (but
after application of subsection (b) of this section) adjust the allotments of such State in accordance with such request and shall notify the
State agency; except that the aggregate of the
portions so transferred from an allotment for a
fiscal year pursuant to this paragraph may not
exceed the amount specified with respect to
such allotment in clause (A), (B), (C), or (D), as
the case may be, of subsection (b)(1) of this section which is applicable to such State.
(2) In addition to the transfer of portions of allotments under paragraph (1), upon the request
of any State that a specified portion of any allotment of such State under subsection (a) of
this section, other than an allotment for grants
for the construction of public or other nonprofit
rehabilitation facilities, be added to another allotment of such State under such subsection,
other than an allotment for grants for the construction of public or other nonprofit hospitals
and public health centers, and upon simultaneous certification to the Secretary by the
State agency in such State to the effect that—
(A) it has afforded a reasonable opportunity
to make applications for the portion so specified and there have been no approvable applications for such portion, or
(B) in the case of a request to transfer a portion of an allotment for grants for the construction of public or other nonprofit hospitals and public health centers, use of such
portion as requested by such State agency will
better carry out the purposes of this subchapter,
the Secretary shall promptly (but after application of subsection (b) of this section) adjust the
allotments of such State in accordance with
such request and shall notify the State agency.
(3) In addition to the transfer of portions of allotments under paragraph (1) or (2), upon the request of any State that a specified portion of an
allotment of such State under paragraph (2) of
subsection (a) of this section be added to an allotment of such State under paragraph (1) of
such subsection for grants for the construction
of public or other nonprofit hospitals and public

§ 291b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health centers, and upon simultaneous certification by the State agency in such State to the
effect that the need for new public or other nonprofit hospitals and public health centers is substantially greater than the need for modernization of facilities referred to in paragraph (a) or
(b) of section 291a of this title, the Secretary
shall promptly (but after application of subsection (b) of this section) adjust the allotments
of such State in accordance with such request
and shall notify the State agency.
(4) After adjustment of allotments of any
State, as provided in paragraph (1), (2), or (3) of
this subsection, the allotments as so adjusted
shall be deemed to be the State’s allotments
under this section.
(f) Request by State to transfer portion of allotment
In accordance with regulations, any State may
file with the Surgeon General a request that a
specified portion of an allotment to it under this
part for grants for construction of any type of
facility, or for modernization of facilities, be
added to the corresponding allotment of another
State for the purpose of meeting a portion of the
Federal share of the cost of a project for the
construction of a facility of that type in such
other State, or for modernization of a facility in
such other State, as the case may be. If it is
found by the Surgeon General (or, in the case of
a rehabilitation facility, by the Surgeon General
and the Secretary) that construction or modernization of the facility with respect to which
the request is made would meet needs of the
State making the request and that use of the
specified portion of such State’s allotment, as
requested by it, would assist in carrying out the
purposes of this subchapter, such portion of such
State’s allotment shall be added to the corresponding allotment of the other State, to be
used for the purpose referred to above.
(July 1, 1944, ch. 373, title VI, § 602, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 448; amended Pub. L. 90–574, title IV, § 402(b), Oct. 15, 1968,
82 Stat. 1011; Pub. L. 91–296, title I, §§ 103(a), (b),
104, 116(a), 119(a)–(c), 122, June 30, 1970, 84 Stat.
338, 341, 343, 344.)
PRIOR PROVISIONS
A prior section 291b, act July 1, 1944, ch. 373, title VI,
§ 612, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041, related to a State application for funds, its requirements
and its approval, prior to the general amendment of
this subchapter by Pub. L. 88–443.
A prior section 291c, act July 1, 1944, ch. 373, title VI,
§ 624, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1941, related to subject matter similar to this section, prior to
the general amendment of this subchapter by Pub. L.
88–443.
A prior section 291g, act July 1, 1944, ch. 373, title VI,
§ 624, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended June 29, 1948, ch. 728, § 1, 62 Stat. 1103; Oct. 25,
1949, ch. 722, §§ 3(b), 7, 63 Stat. 899, 901; Aug. 1, 1956, ch.
852, § 19(c), 70 Stat. 911; Sept. 25, 1962, Pub. L. 87–688,
§ 4(a)(3), 76 Stat. 587, related to subject matter similar
to this section, prior to the general amendment of this
subchapter by Pub. L. 88–443.
A prior section 291i(a) to (d), act July 1, 1944, ch. 373,
title VI, § 631, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat.
1041; amended June 19, 1948, ch. 544, 62 Stat. 531; Aug. 1,
1956, ch. 852, § 19(a), (b), 70 Stat. 911; June 25, 1959, Pub.
L. 86–70, § 31(c), 73 Stat. 149; July 12, 1960, Pub. L. 86–624,

Page 734

§ 29(d), 74 Stat. 419; Sept. 25, 1962, Pub. L. 87–688, § 4(a)(2),
76 Stat. 587, related to subject matter similar to this
section, prior to the general amendment of this subchapter by Pub. L. 88–443.
A prior section 291n–1, act July 1, 1944, ch. 373, title
VI, § 637, formerly § 654(c), as added July 12, 1954, ch. 471,
§ 3, 68 Stat. 463, renumbered and amended Aug. 14, 1959,
Pub. L. 86–158, title II, § 201, 73 Stat. 349, related to subject matter similar to this section, prior to the general
amendment of this subchapter by Pub. L. 88–443.
A prior section 291r, act July 1, 1944, ch. 373, title VI,
§ 648, as added July 12, 1954, ch. 471, § 2, 68 Stat. 462, related to subject matter similar to this section, prior to
the general amendment of this subchapter by Pub. L.
88–443.
A prior section 291t, act July 1, 1944, ch. 373, title VI,
§ 652, as added July 12, 1954, ch. 471, § 3, 68 Stat. 462;
amended Aug. 1, 1956, ch. 852, § 19(c), 70 Stat. 911; Oct.
5, 1961, Pub. L. 87–395, § 3(b), 75 Stat. 825; Sept. 25, 1962,
Pub. L. 87–688, § 4(a)(3), 76 Stat. 587, related to subject
matter similar to this section, prior to the general
amendment of this subchapter by Pub. L. 88–443.
A prior section 291v(b), act July 1, 1944, ch. 373, title
VI, § 654, as added July 12, 1954, ch. 471, § 3, 68 Stat. 463,
related to subject matter similar to this section, prior
to the general amendment of this subchapter by Pub.
L. 88–443.
AMENDMENTS
1970—Subsec. (a)(1). Pub. L. 91–296, § 103(a), substituted ‘‘sums appropriated for such year’’ for ‘‘new
hospital portion of the sums appropriated for such
year’’ and struck out provision setting out a formula
for determining new hospital portion of sums appropriated pursuant to section 291a(b) of this title.
Subsec. (a)(2). Pub. L. 91–296, § 103(a), substituted
‘‘Secretary’’ for ‘‘Surgeon General’’, and substituted
reference to sums appropriated for such year under section 291a(c) of this title for reference to remainder of
sums appropriated pursuant to section 291a(b) of this
title (which portion was to be available for grants for
modernization of facilities referred to in paragraphs (a)
and (b) of section 291a of this title).
Subsec. (b)(1)(A). Pub. L. 91–296, §§ 103(b)(1), 119(a)(1),
substituted ‘‘$50,000’’ and ‘‘$100,000’’ for ‘‘$25,000’’ and
‘‘$50,000’’, respectively, and inserted reference to Trust
Territory of the Pacific Islands.
Subsec. (b)(1)(B). Pub. L. 91–296, §§ 103(b)(2), 116(a),
119(a)(1), substituted ‘‘$100,000’’ and ‘‘$200,000’’ for
‘‘$50,000’’ and ‘‘$100,000’’, respectively, substituted ‘‘outpatient facilities’’ for ‘‘diagnostic or treatment centers’’, and inserted reference to Trust Territory of the
Pacific Islands.
Subsec. (b)(1)(C). Pub. L. 91–296, §§ 103(b)(3), 119(a)(1),
substituted ‘‘$200,000’’ and ‘‘$300,000’’ for ‘‘$100,000’’ and
‘‘$200,000’’, respectively, and inserted reference to Trust
Territory of the Pacific Islands.
Subsec. (b)(1)(D). Pub. L. 91–296, § 103(b)(4), added subpar. (D).
Subsecs. (b)(2), (c)(1). Pub. L. 91–296, § 119(a)(2), (b), inserted reference to Trust Territory of the Pacific Islands.
Subsec. (d)(1). Pub. L. 91–296, §§ 119(c), 122, inserted
reference to Trust Territory of the Pacific Islands and
substituted two years for one year as the time span following a year in which allotted sums remaining unobligated at the end thereof during which such unobligated
funds remain available.
Subsec. (d)(2). Pub. L. 91–296, § 119(c), inserted references to Trust Territory of the Pacific Islands.
Subsec. (e). Pub. L. 91–296, § 104, authorized any State
to make transfers of any amount up to the minimum
amount allotted to any state for a particular category
and authorized all amounts above such minimums to be
transferred from one category of assistance to another
without restriction on the amounts with the exception
that no funds could be transferred from rehabilitation
facilities category or to new hospital construction category and that all transfers be justified on the basis
that either there are no approvable applications in the

Page 735

TITLE 42—THE PUBLIC HEALTH AND WELFARE

category from which funds are transferred or, in case of
transfers from new hospital construction category, the
purposes of the program would be better served by the
transfer, and authorized transfers to new hospital construction from modernization category if need is greater.
1968—Subsec. (a)(1). Pub. L. 90–574, § 402(b)(1), inserted
provision for two-thirds of the sums appropriated in the
case of the fifth fiscal year thereafter.
Subsec. (e)(2)(E). Pub. L. 90–574, § 402(b)(2), added subpar. (E).
EFFECTIVE DATE OF 1970 AMENDMENT
Section 103(a) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to appropriations made pursuant to section 291a
of this title for fiscal years beginning after June 30,
1970.
Section 103(b) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to allotments from appropriations made pursuant
to section 291a of this title for fiscal years beginning
after June 30, 1970.
Section 104 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
allotments made pursuant to section 291a of this title
for fiscal years beginning after June 30, 1970.
Section 119(e) of Pub. L. 91–296 provided that: ‘‘The
amendments made by this section [amending this section and section 291o of this title] shall apply with respect to allotments (and grants therefrom) under part
A of title VI of the Public Health Service Act [this
part] for fiscal years ending after June 30, 1970, and
with respect to loan guarantees and loans under part B
of such title [part B of this subchapter] made after
June 30, 1970.’’
Section 122 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
allotments made from appropriations under section
291a of this title for fiscal years beginning after June
30, 1970.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
AVAILABILITY OF FUNDS FOR OBLIGATION FROM
ALLOTMENT FOR ADMINISTRATION OF PLAN
Pub. L. 93–641, § 5(b), Jan. 4, 1975, 88 Stat. 2274, provided that any State having in the fiscal year ending
June 30, 1975 or the next fiscal year funds available for
obligation from its allotments under section 291a et
seq. of this title, may in such fiscal year use for the
proper and efficient administration during such year of
its State plan an amount of such funds not exceeding
4 percentum of such funds or $100,000, whichever is less.
ALLOTMENT STUDY; REPORT TO CONGRESS
Section 103(c) of Pub. L. 91–296 directed Secretary to
study effects of the formula specified in subsec. (a)(1) of
this section for allotment among the States for construction of health facilities, with results of such study

§ 291c

together with recommendations for change to be reported to Congress on May 15, 1972.
APPROVAL OF APPLICATION FOR MODERNIZATION PRIOR
TO JULY 1, 1965, OR BEFORE APPROVAL OF A STATE
PLAN
Section 3(b)(5) of Pub. L. 88–443, providing that no application for modernization of any facility may be approved for purposes of receiving funds before the approval of a State plan, as well as other requirements,
is set out as an Effective Date note under section 291 of
this title.

§ 291c. General regulations
The Surgeon General, with the approval of the
Federal Hospital Council and the Secretary of
Health and Human Services shall by general regulations prescribe—
(a) Priority of projects; determination
the general manner in which the State agency shall determine the priority of projects
based on the relative need of different areas
lacking adequate facilities of various types for
which assistance is available under this part,
giving special consideration—
(1) in the case of projects for the construction of hospitals, to facilities serving areas
with relatively small financial resources
and, at the option of the State, rural communities;
(2) in the case of projects for the construction of rehabilitation facilities, to facilities
operated in connection with a university
teaching hospital which will provide an integrated program of medical, psychological,
social, and vocational evaluation and services under competent supervision;
(3) in the case of projects for modernization of facilities, to facilities serving densely populated areas;
(4) in the case of projects for construction
or modernization of outpatient facilities, to
any outpatient facility that will be located
in, and provide services for residents of, an
area determined by the Secretary to be a
rural or urban poverty area;
(5) to projects for facilities which, alone or
in conjunction with other facilities, will provide comprehensive health care, including
outpatient and preventive care as well as
hospitalization;
(6) to facilities which will provide training
in health or allied health professions; and
(7) to facilities which will provide to a significant extent, for the treatment of alcoholism;
(b) Standards of construction and equipment
general standards of construction and equipment for facilities of different classes and in
different types of location, for which assistance is available under this part;
(c) Criteria for determining needs for beds,
hospitals and other facilities; plans for distribution of beds and facilities
criteria for determining needs for general
hospital and long-term care beds, and needs
for hospitals and other facilities for which aid
under this part is available, and for developing
plans for the distribution of such beds and facilities;

§ 291d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Criteria for determining need for modernization
criteria for determining the extent to which
existing facilities, for which aid under this
part is available, are in need of modernization;
and
(e) State plan requirements; assurances necessary for approval of application
that the State plan shall provide for adequate hospitals, and other facilities for which
aid under this part is available, for all persons
residing in the State, and adequate hospitals
(and such other facilities) to furnish needed
services for persons unable to pay therefor.
Such regulations may also require that before
approval of an application for a project is recommended by a State agency to the Surgeon
General for approval under this part, assurance shall be received by the State from the
applicant that (1) the facility or portion thereof to be constructed or modernized will be
made available to all persons residing in the
territorial area of the applicant; and (2) there
will be made available in the facility or portion thereof to be constructed or modernized a
reasonable volume of services to persons unable to pay therefor, but an exception shall be
made if such a requirement is not feasible
from a financial viewpoint.
(July 1, 1944, ch. 373, title VI, § 603, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 451; amended Pub. L. 88–581, § 3(b), Sept. 4, 1964, 78 Stat. 919;
Pub. L. 91–296, title I, § 110, June 30, 1970, 84 Stat.
339; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695.)
PRIOR PROVISIONS
A prior section 291c, act July 1, 1944, ch. 373, title VI,
§ 613, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041, related to allotments to States, the determination of
their amount, and the disposition of unexpended funds,
prior to the general amendment of this subchapter by
Pub. L. 88–443. See section 291(a), (b) and (d) of this
title.
Provisions similar to those comprising this section
were contained in a prior section 291e, act July 1, 1944,
ch. 373, title VI, § 622, as added Aug. 13, 1946, ch. 958, § 2,
60 Stat. 1041; amended 1953 Reorg. Plan No. 1, §§ 5, 8, eff.
Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631, prior to the general amendment of this subchapter by Pub. L. 88–443.
AMENDMENTS
1970—Subsec. (a). Pub. L. 91–296 struck out from cl. (1)
provisions requiring that States give special consideration for projects for hospitals serving rural areas but
inserted provisions making such preference optional
with each State and added cls. (4) to (7).
1964—Subsec. (a)(4). Pub. L. 88–581 struck out cl. (4)
relating to hospital facilities which ‘‘will include new
or expanded facilities for nurse training’’.
EFFECTIVE DATE OF 1970 AMENDMENT
Section 110 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
applications approved under this subchapter after June
30, 1970.
EFFECTIVE DATE OF 1964 AMENDMENT
Section 3(b) of Pub. L. 88–581 provided that the
amendments made by such section 3(b) [amending this
section and sections 291o and 293c of this title] are effective with respect to applications for grants from appropriations for fiscal years beginning after June 30,
1965.

Page 736

TRANSFER OF FUNCTIONS
‘‘Secretary of Health and Human Services’’ substituted in text for ‘‘Secretary of Health, Education,
and Welfare’’ pursuant to section 509(b) of Pub. L. 96–88
which is classified to section 3508(b) of Title 20, Education.
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20.

§ 291d. State plans
(a) Submission; requirements
Any State desiring to participate in this part
may submit a State plan. Such plan must—
(1) designate a single State agency as the
sole agency for the administration of the plan,
or designate such agency as the sole agency
for supervising the administration of the plan;
(2) contain satisfactory evidence that the
State agency designated in accordance with
paragraph (1) of this subsection will have authority to carry out such plan in conformity
with this part;
(3) provide for the designation of a State advisory council which shall include (A) representatives of nongovernmental organizations or groups, and of public agencies, concerned with the operation, construction, or
utilization of hospital or other facilities for diagnosis, prevention, or treatment of illness or
disease, or for provision of rehabilitation services, and representatives particularly concerned with education or training of health
professions personnel, and (B) an equal number of representatives of consumers familiar
with the need for the services provided by such
facilities, to consult with the State agency in
carrying out the plan, and provide, if such
council does not include any representatives
of nongovernmental organizations or groups,
or State agencies, concerned with rehabilitation, for consultation with organizations,
groups, and State agencies so concerned;
(4) set forth, in accordance with criteria established in regulations prescribed under section 291c of this title and on the basis of a
statewide inventory of existing facilities, a
survey of need, and (except to the extent provided by or pursuant to such regulations) community, area, or regional plans—
(A) the number of general hospital beds
and long-term care beds, and the number and
types of hospital facilities and facilities for
long-term care, needed to provide adequate
facilities for inpatient care of people residing in the State, and a plan for the distribution of such beds and facilities in service
areas throughout the State;
(B) the public health centers needed to
provide adequate public health services for
people residing in the State, and a plan for
the distribution of such centers throughout
the State;
(C) the outpatient facilities needed to provide adequate diagnostic or treatment services to ambulatory patients residing in the

Page 737

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State, and a plan for distribution of such facilities throughout the State;
(D) the rehabilitation facilities needed to
assure adequate rehabilitation services for
disabled persons residing in the State, and a
plan for distribution of such facilities
throughout the State; and
(E) effective January 1, 1966, the extent to
which existing facilities referred to in section 291a(a) or (b) of this title in the State
are in need of modernization;
(5) set forth a construction and modernization program conforming to the provisions set
forth pursuant to paragraph (4) of this subsection and regulations prescribed under section 291c of this title and providing for construction or modernization of the hospital or
long-term care facilities, public health centers, outpatient facilities, and rehabilitation
facilities which are needed, as determined
under the provisions so set forth pursuant to
paragraph (4) of this subsection;
(6) set forth, with respect to each of such
types of medical facilities, the relative need,
determined in accordance with regulations
prescribed under section 291c of this title, for
projects for facilities of that type, and provide
for the construction or modernization, insofar
as financial resources available therefor and
for maintenance and operation make possible,
in the order of such relative need;
(7) provide minimum standards (to be fixed
in the discretion of the State) for the maintenance and operation of facilities providing inpatient care which receive aid under this part
and, effective July 1, 1966, provide for enforcement of such standards with respect to
projects approved by the Surgeon General
under this part after June 30, 1964;
(8) provide such methods of administration
of the State plan, including methods relating
to the establishment and maintenance of personnel standards on a merit basis (except that
the Surgeon General shall exercise no authority with respect to the selection, tenure of office, or compensation of any individual employed in accordance with such methods), as
are found by the Surgeon General to be necessary for the proper and efficient operation of
the plan;
(9) provide for affording to every applicant
for a construction or modernization project an
opportunity for a hearing before the State
agency;
(10) provide that the State agency will make
such reports, in such form and containing such
information, as the Surgeon General may from
time to time reasonably require, and will keep
such records and afford such access thereto as
the Surgeon General may find necessary to assure the correctness and verification of such
reports;
(11) provide that the Comptroller General of
the United States or his duly authorized representatives shall have access for the purpose
of audit and examination to the records specified in paragraph (10) of this subsection;
(12) provide that the State agency will from
time to time, but not less often than annually,
review its State plan and submit to the Surgeon General any modifications thereof which
it considers necessary; and

§ 291d

(13) Effective July 1, 1971, provide that before any project for construction or modernization of any general hospital is approved
by the State agency there will be reasonable
assurance of adequate provision for extended
care services (as determined in accordance
with regulations) to patients of such hospital
when such services are medically appropriate
for them, with such services being provided in
facilities which (A) are structurally part of,
physically connected with, or in immediate
proximity to, such hospital, and (B) either (i)
are under the supervision of the professional
staff of such hospital or (ii) have organized
medical staffs and have in effect transfer
agreements with such hospital; except that
the Secretary may, at the request of the State
agency, waive compliance with clause (A) or
(B), or both such clauses, as the case may be,
in the case of any project if the State agency
has determined that compliance with such
clause or clauses in such case would be inadvisable.
(b) Approval by Surgeon General; hearing after
disapproval
The Surgeon General shall approve any State
plan and any modification thereof which complies with the provisions of subsection (a) of this
section. If any such plan or modification thereof
shall have been disapproved by the Surgeon General for failure to comply with subsection (a) of
this section, the Federal Hospital Council shall,
upon request of the State agency, afford it an
opportunity for hearing. If such Council determines that the plan or modification complies
with the provisions of such subsection, the Surgeon General shall thereupon approve such plan
or modification.
(July 1, 1944, ch. 373, title VI, § 604, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 452; amended Pub. L. 91–296, title I, §§ 115, 116(b), (c), 123,
June 30, 1970, 84 Stat. 341, 342, 344.)
PRIOR PROVISIONS
A prior section 291d, act July 1, 1944, ch. 373, title VI,
§ 621, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended Oct. 25, 1949, ch. 722, § 2(a), 63 Stat. 898; July
27, 1953, ch. 243, 67 Stat. 196; Aug. 2, 1956, ch. 871, title
IV, § 401, 70 Stat. 929; Aug. 14, 1958, Pub. L. 85–664, § 1(a),
72 Stat. 616, authorized appropriations for construction
of hospitals and related facilities, prior to the general
amendment of this subchapter by Pub. L. 88–443. See
section 291a of this title.
Provisions similar to those comprising this section
were contained in a prior section 291f(a), (b), act July
1, 1944, ch. 373, title VI, § 623, as added Aug. 13, 1946, ch.
958, § 2, 60 Stat. 1041, prior to the general amendment of
this subchapter by Pub. L. 88–443.
AMENDMENTS
1970—Subsec. (a)(3). Pub. L. 91–296, § 115, inserted requirement that State advisory councils include representatives particularly concerned with education or
training of health professions personnel.
Subsec. (a)(4)(C). Pub. L. 91–296, § 116(b), substituted
‘‘outpatient facilities’’ for ‘‘diagnostic or treatment
centers’’ and ‘‘such facilities’’ for ‘‘such centers’’.
Subsec. (a)(5). Pub. L. 91–296, § 116(c), substituted
‘‘outpatient facilities’’ for ‘‘diagnostic or treatment
centers’’.
Subsec. (a)(13). Pub. L. 91–296, § 123, added par. (13).
EFFECTIVE DATE OF 1970 AMENDMENT
Section 115 of Pub. L. 91–296 provided that the amendment made by that section is effective July 1, 1970.

§ 291e

TITLE 42—THE PUBLIC HEALTH AND WELFARE
TRANSFER OF FUNCTIONS

Functions, powers, and duties of Secretary of Health
and Human Services under subsec. (a)(8) of this section,
insofar as relates to the prescription of personnel
standards on a merit basis, transferred to Office of Personnel Management, see section 4728(a)(3)(C) of this
title.
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
FUNDS FOR MODERNIZATION PROJECTS; CONDITIONS TO
BE MET BEFORE APPROVAL
Section 3(b)(5) of Pub. L. 88–443 provided that no application with respect to a modernization project may
be approved for purposes of receiving funds from an allotment under section 291(a)(2) of this title before July
1, 1965, or before a State plan has been approved, as well
as certain other requirements. See Effective Date note
under section 291 of this title.

§ 291e. Projects for construction or modernization
(a) Application; contents
For each project pursuant to a State plan approved under this part, there shall be submitted
to the Surgeon General, through the State agency, an application by the State or a political
subdivision thereof or by a public or other nonprofit agency. If two or more such agencies join
in the project, the application may be filed by
one or more of such agencies. Such application
shall set forth—
(1) a description of the site for such project;
(2) plans and specifications therefor, in accordance with regulations prescribed under
section 291c of this title;
(3) reasonable assurance that title to such
site is or will be vested in one or more of the
agencies filing the application or in a public or
other nonprofit agency which is to operate the
facility on completion of the project;
(4) reasonable assurance that adequate financial support will be available for the completion of the project and for its maintenance
and operation when completed;
(5) reasonable assurance that all laborers
and mechanics employed by contractors or
subcontractors in the performance of construction or modernization on the project will
be paid wages at rates not less than those prevailing on similar work in the locality as determined by the Secretary of Labor in accordance with sections 3141–3144, 3146, and 3147 of
title 40; and the Secretary of Labor shall have
with respect to the labor standards specified
in this paragraph the authority and functions
set forth in Reorganization Plan Numbered 14
of 1950 (15 F.R. 3176) and section 3145 of title 40;
and
(6) a certification by the State agency of the
Federal share for the project.
(b) Approval by Surgeon General; requisites; additional approval by Secretary of Health and
Human Services
The Surgeon General shall approve such application if sufficient funds to pay the Federal

Page 738

share of the cost of such project are available
from the appropriate allotment to the State,
and if the Surgeon General finds (1) that the application contains such reasonable assurance as
to title, financial support, and payment of prevailing rates of wages; (2) that the plans and
specifications are in accord with the regulations
prescribed pursuant to section 291c of this title;
(3) that the application is in conformity with
the State plan approved under section 291d of
this title and contains an assurance that in the
operation of the project there will be compliance with the applicable requirements of the
regulations prescribed under section 291c(e) of
this title, and with State standards for operation and maintenance; and (4) that the application has been approved and recommended by the
State agency, opportunity has been provided,
prior to such approval and recommendation, for
consideration of the project by the public or
nonprofit private agency or organization which
has developed the comprehensive regional, metropolitan area, or other local area plan or plans
referred to in section 246(b) of this title covering
the area in which such project is to be located
or, if there is no such agency or organization, by
the State agency administering or supervising
the administration of the State plan approved
under section 246(a) of this title, and the application is for a project which is entitled to priority over other projects within the State in accordance with the regulations prescribed pursuant to section 291c(a) of this title. Notwithstanding the preceding sentence, the Surgeon General
may approve such an application for a project
for construction or modernization of a rehabilitation facility only if it is also approved by the
Secretary of Health and Human Services.
(c) Opportunity for hearing required prior to disapproval
No application shall be disapproved until the
Surgeon General has afforded the State agency
an opportunity for a hearing.
(d) Amendments subject to same approval as
original applications
Amendment of any approved application shall
be subject to approval in the same manner as an
original application.
(e) Outpatient facilities; requirements of applicants
Notwithstanding any other provision of this
subchapter, no application for an outpatient facility shall be approved under this section unless the applicant is (1) a State, political subdivision, or public agency, or (2) a corporation
or association which owns and operates a nonprofit hospital (as defined in section 291o of this
title) or which provides reasonable assurance
that the services of a general hospital will be
available to patients of such facility who are in
need of hospital care.
(July 1, 1944, ch. 373, title VI, § 605, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 453; amended Pub. L. 91–296, title I, §§ 111(a), 116(e), June 30,
1970, 84 Stat. 340, 342; Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695.)

Page 739

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

Reorganization Plan Numbered 14 of 1950, referred to
in subsec. (a)(5), is set out in the Appendix to Title 5,
Government Organization and Employees.
CODIFICATION
In subsec. (a) (5), ‘‘sections 3141–3144, 3146, and 3147 of
title 40’’ substituted for ‘‘the Davis-Bacon Act, as
amended (40 U.S.C. 276a—276a–5)’’ and ‘‘section 3145 of
title 40’’ substituted for ‘‘section 2 of the Act of June
13, 1934, as amended (40 U.S.C. 276c)’’ on authority of
Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303, the
first section of which enacted Title 40, Public Buildings, Property, and Works.
PRIOR PROVISIONS
A prior section 291e, act July 1944, ch. 373, title VI,
§ 622, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631, authorized Surgeon General to
prescribe general regulations, prior to the general
amendment of this subchapter by Pub. L. 88–443. See
section 291c of this title.
A prior section 291h(a), (c), act July 1, 1944, ch. 373,
title VI, § 625, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat.
1041; amended Oct. 25, 1949, ch. 722, § 8, 63 Stat. 901, related to subject matter similar to this section, prior to
the general amendment of this subchapter by Pub. L.
88–443.
A prior section 291v(d), act July 1, 1944, ch. 373, title
VI, § 654, as added July 12, 1954, ch. 471, § 3, 68 Stat. 463,
related to subject matter similar to this section, prior
to the general amendment of this subchapter by Pub.
L. 88–443.
AMENDMENTS
1970—Subsec. (b)(4). Pub. L. 91–296, § 111(a), inserted
provisions requiring that the appropriate area wide
health planning agency be given an opportunity to consider the project for which an application is made before approval is given.
Subsec. (e). Pub. L. 91–296, § 116(e), substituted ‘‘an
outpatient facility’’ for ‘‘a diagnostic or treatment center’’ and inserted provisions extending coverage to include corporations and associations which, although
not owning or operating hospitals offer services of a
general hospital to patients in need of hospital care.
EFFECTIVE DATE OF 1970 AMENDMENT
Section 111(a) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to applications approved under this subchapter
after June 30, 1970.
Amendment by section 116(e) of Pub. L. 91–296 applicable with respect to applications approved under this
subchapter after June 30, 1970, see section 116(g) of Pub.
L. 91–296, set out as a note under section 291o of this
title.
TRANSFER OF FUNCTIONS
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (b) pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20.
APPLICATIONS APPROVED PRIOR TO AUG. 18, 1964
Section 3(b)(1) of Pub. L. 88–443, providing that applications approved, and allotments appropriated prior to

§ 291f

Aug. 18, 1964, shall be governed by this subchapter as in
effect prior to such date, is set out as an Effective Date
note under section 291 of this title.
FUNDS FOR MODERNIZATION PROJECTS; CONDITIONS TO
BE MET BEFORE APPROVAL
Section 3(b)(5) of Pub. L. 88–443 provided that no application with respect to a modernization project may
be approved for purposes of receiving funds from an allotment under section 291(a)(2) of this title before July
1, 1965, or before a State plan has been approved, as well
as certain other requirements. See Effective Date note
set out under section 291 of this title.

§ 291f. Payments for construction or modernization
(a) Certification of work by Surgeon General;
conditions affecting payments
Upon certification to the Surgeon General by
the State agency, based upon inspection by it,
that work has been performed upon a project, or
purchases have been made, in accordance with
the approved plans and specifications, and that
payment of an installment is due to the applicant, such installment shall be paid to the
State, from the applicable allotment of such
State, except that (1) if the State is not authorized by law to make payments to the applicant,
or if the State so requests, the payment shall be
made directly to the applicant, (2) if the Surgeon General, after investigation or otherwise,
has reason to believe that any act (or failure to
act) has occurred requiring action pursuant to
section 291g of this title, payment may, after he
has given the State agency notice of opportunity for hearing pursuant to such section, be
withheld, in whole or in part, pending corrective
action or action based on such hearing, and (3)
the total of payments under this subsection with
respect to such project may not exceed an
amount equal to the Federal share of the cost of
construction of such project.
(b) Additional payments in cases of amended applications
In case an amendment to an approved application is approved as provided in section 291e of
this title or the estimated cost of a project is revised upward, any additional payment with respect thereto may be made from the applicable
allotment of the State for the fiscal year in
which such amendment or revision is approved.
(c) Administration expenses; use of portion of allotments to defray; manner of payment
(1) At the request of any State, a portion of
any allotment or allotments of such State under
this part shall be available to pay one-half (or
such smaller share as the State may request) of
the expenditures found necessary by the Surgeon General for the proper and efficient administration during such year of the State plan approved under this part; except that not more
than 4 per centum of the total of the allotments
of such State for a year, or $100,000, whichever is
less, shall be available for such purpose for such
year. Payments of amounts due under this paragraph may be made in advance or by way of reimbursement, and in such installments, as the
Surgeon General may determine.
(2) Any amount paid under paragraph (1) of
this subsection to any State for any fiscal year

§ 291g

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall be paid on condition that there shall be expended from State sources for such year for administration of the State plan approved under
this part not less than the total amount expended for such purposes from such sources during the fiscal year ending June 30, 1970.
(July 1, 1944, ch. 373, title VI, § 606, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 454; amended Pub. L. 91–296, title I, § 112, June 30, 1970, 84
Stat. 340.)
PRIOR PROVISIONS
A prior section 291f, act July 1, 1944, ch. 373, title VI,
§ 623, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended June 19, 1948, ch. 554, 62 Stat. 536; Oct. 25, 1949,
ch. 722, § 3(a), 63 Stat. 899, related to State plans, their
submission, and their requirements, prior to the general amendment of this subchapter by Pub. L. 88–443.
See section 291d of this title.
Provisions similar to those comprising subsec. (a) of
this section were contained in former section 291h(b),
acts July 1, 1944, ch. 373, title VI, § 625, as added Aug. 13,
1946, ch. 958, § 2, 60 Stat. 1041; amended Oct. 25, 1949, ch.
722, § 3(b), 63 Stat. 899, prior to the general amendment
of this subchapter by Pub. L. 88–443.
AMENDMENTS
1970—Subsec. (c)(1). Pub. L. 91–296, § 112(1), substituted
‘‘4 per centum’’ for ‘‘2 per centum’’ and ‘‘$100,000 for
$50,000’’.
Subsec. (c)(2). Pub. L. 91–296, § 112(2), substituted
‘‘June 30, 1970’’ for ‘‘June 30, 1964’’.
EFFECTIVE DATE OF 1970 AMENDMENT
Section 112 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
expenditures under a State plan approved under this
subchapter which are made for administration of such
plan during any fiscal year beginning after June 30,
1970.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 291g. Withholding of payments; noncompliance
with requirements
Whenever the Surgeon General, after reasonable notice and opportunity for hearing to the
State agency designated as provided in section
291d(a)(1) of this title, finds—
(a) that the State agency is not complying
substantially with the provisions required by
section 291d of this title to be included in its
State plan; or
(b) that any assurance required to be given
in an application filed under section 291e of
this title is not being or cannot be carried out;
or
(c) that there is a substantial failure to
carry out plans and specifications approved by
the Surgeon General under section 291e of this
title; or
(d) that adequate State funds are not being
provided annually for the direct administration of the State plan,
the Surgeon General may forthwith notify the
State agency that—

Page 740

(e) no further payments will be made to the
State under this part, or
(f) no further payments will be made from
the allotments of such State from appropriations under any one or more subparagraphs or
paragraphs of section 291a of this title, or for
any project or projects, designated by the Surgeon General as being affected by the action
or inaction referred to in paragraph (a), (b),
(c), or (d) of this section,
as the Surgeon General may determine to be appropriate under the circumstances; and, except
with regard to any project for which the application has already been approved and which is not
directly affected, further payments may be
withheld, in whole or in part, until there is no
longer any failure to comply (or carry out the
assurance or plans and specifications or provide
adequate State funds, as the case may be) or, if
such compliance (or other action) is impossible,
until the State repays or arranges for the repayment of Federal moneys to which the recipient
was not entitled.
(July 1, 1944, ch. 373, title VI, § 607, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 455.)
PRIOR PROVISIONS
A prior section 291g, act July 1, 1944, ch. 373, title VI,
§ 624, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended June 29, 1948, ch. 728, § 1, 62 Stat. 1103; Oct. 25,
1949, ch. 722, §§ 3(b), 7, 63 Stat. 899, 901; Aug. 1, 1956, ch.
852, § 19(c), 70 Stat. 911; Sept. 25, 1962, Pub. L. 87–688,
§ 4(a)(3), 76 Stat. 587, authorized allotments to States
for construction, specified their amount, and provided
for availability for unexpended funds, prior to the general amendment of this subchapter by Pub. L. 88–443.
See section 291b of this title.
Provisions similar to those comprising this section
were contained in former section 291j(a), acts July 1,
1944, ch. 373, title VI, § 632, as added Aug. 13, 1946, ch.
958, § 2, 60 Stat. 1041; amended Oct. 25, 1949, ch. 722, § 4,
63 Stat. 900; July 12, 1954, ch. 471, § 4(g), 68 Stat. 466,
prior to the general amendment of this subchapter by
Pub. L. 88–443.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 291h. Judicial review
(a) Refusal to approve application; procedure; jurisdiction of court of appeals
If the Surgeon General refuses to approve any
application for a project submitted under section 291e of this title or section 291j of this title,
the State agency through which such application was submitted, or if any State is dissatisfied with his action under section 291g of this
title such State may appeal to the United States
court of appeals for the circuit in which such
State is located, by filing a petition with such
court within sixty days after such action. A
copy of the petition shall be forthwith transmitted by the clerk of the court to the Surgeon
General, or any officer designated by him for

Page 741

TITLE 42—THE PUBLIC HEALTH AND WELFARE

that purpose. The Surgeon General shall thereupon file in the court the record of the proceedings on which he based his action, as provided in
section 2112 of title 28. Upon the filing of such
petition, the court shall have jurisdiction to affirm the action of the Surgeon General or to set
it aside, in whole or in part, temporarily or permanently, but until the filing of the record, the
Surgeon General may modify or set aside his
order.
(b) Conclusiveness of Surgeon General’s findings;
remand; new or modified findings
The findings of the Surgeon General as to the
facts, if supported by substantial evidence, shall
be conclusive, but the court, for good cause
shown, may remand the case to the Surgeon
General to take further evidence, and the Surgeon General may thereupon make new or modified findings of fact and may modify his previous
action, and shall file in the court the record of
the further proceedings. Such new or modified
findings of fact shall likewise be conclusive if
supported by substantial evidence.
(c) Review by Supreme Court; stay of Surgeon
General’s action
The judgment of the court affirming or setting
aside, in whole or in part, any action of the Surgeon General shall be final, subject to review by
the Supreme Court of the United States upon
certiorari or certification as provided in section
1254 of title 28. The commencement of proceedings under this section shall not, unless so specifically ordered by the court, operate as a stay
of the Surgeon General’s action.
(July 1, 1944, ch. 373, title VI, § 608, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 456.)
PRIOR PROVISIONS
A prior section 291h, act July 1, 1944, ch. 373, title VI,
§ 625, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended Oct. 25, 1949, ch. 722, §§ 3(b–d), 8, 63 Stat. 899,
901; July 12, 1954, ch. 471, § 4(b), 68 Stat. 464, related to
projects for construction, the application required and
its contents and approval by the Surgeon General, and
provided for a hearing prior to disapproval of the application, prior to the general amendment of this subchapter by Pub. L. 88–443. See section 291e of this title.
Provisions similar to those comprising this section
were contained in former section 291j(b), act July 1,
1944, ch. 373, title VI, § 632, as added Aug. 13, 1946, ch.
958, § 2, 60 Stat. 1041; amended June 28, 1948, ch. 646,
§ 32(a), 62 Stat. 991; May 24, 1949, ch. 139, § 127, 63 Stat.
107; July 12, 1954, ch. 471, § 4(g), 68 Stat. 466; Aug. 28,
1958, Pub. L. 85–791, § 27, 72 Stat. 950, prior to the general amendment of this subchapter by Pub. L. 88–443.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

§ 291i. Recovery of expenditures under certain
conditions
(a) Persons liable
If any facility with respect to which funds
have been paid under section 291f of this title

§ 291i

shall, at any time within 20 years after the completion of construction or modernization—
(1) be sold or transferred to any entity (A)
which is not qualified to file an application
under section 291e of this title, or (B) which is
not approved as a transferee by the State
agency designated pursuant to section 291d of
this title, or its successor, or
(2) cease to be a public health center or a
public or other nonprofit hospital, outpatient
facility, facility for long-term care, or rehabilitation facility,
the United States shall be entitled to recover,
whether from the transferor or the transferee
(or, in the case of a facility which has ceased to
be public or nonprofit, from the owners thereof)
an amount determined under subsection (c) of
this section.
(b) Notice to Secretary
The transferor of a facility which is sold or
transferred as described in subsection (a)(1) of
this section, or the owner of a facility the use of
which is changed as described in subsection
(a)(2) of this section, shall provide the Secretary
written notice of such sale, transfer, or change
not later than the expiration of 10 days from the
date on which such sale, transfer, or change occurs.
(c) Amount of recovery; interest; interest period
(1) Except as provided in paragraph (2), the
amount the United States shall be entitled to
recover under subsection (a) of this section is an
amount bearing the same ratio to the then value
(as determined by the agreement of the parties
or in an action brought in the district court of
the United States for the district for which the
facility involved is situated) of so much of the
facility as constituted an approved project or
projects as the amount of the Federal participation bore to the cost of the construction or modernization of such project or projects.
(2)(A) After the expiration of—
(i) 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b) of this section, in the
case of a facility which is sold or transferred
or the use of which changes after July 18, 1984,
or
(ii) thirty days after July 18, 1984, or if later
180 days after the date of the sale, transfer, or
change of use for which a notice is required by
subsection (b) of this section, in the case of a
facility which was sold or transferred or the
use of which changed before July 18, 1984.1
the amount which the United States is entitled
to recover under paragraph (1) with respect to a
facility shall be the amount prescribed by paragraph (1) plus interest, during the period described in subparagraph (B), at a rate (determined by the Secretary) based on the average of
the bond equivalent of the weekly ninety-day
Treasury bill auction rate.
(B) The period referred to in subparagraph (A)
is the period beginning—
(i) in the case of a facility which was sold or
transferred or the use of which changed before
July 18, 1984, thirty days after such date or if
1 So

in original. The period probably should be a comma.

§ 291j

TITLE 42—THE PUBLIC HEALTH AND WELFARE

later 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b) of this section,
(ii) in the case of a facility with respect to
which notice is provided in accordance with
subsection (b) of this section, upon the expiration of 180 days after the receipt of such notice, or
(iii) in the case of a facility with respect to
which such notice is not provided as prescribed by subsection (b) of this section, on
the date of the sale, transfer, or change of use
for which such notice was to be provided,
and ending on the date the amount the United
States is entitled to under paragraph (1) is collected.
(d) Waiver
(1) The Secretary may waive the recovery
rights of the United States under subsection
(a)(1) of this section with respect to a facility in
any State if the Secretary determines, in accordance with regulations, that the entity to
which the facility was sold or transferred—
(A) has established an irrevocable trust—
(i) in an amount equal to the greater of
twice the cost of the remaining obligation of
the facility under clause (2) of section 291c(e)
of this title or the amount, determined
under subsection (c) of this section, that the
United States is entitled to recover, and
(ii) which will only be used by the entity
to provide the care required by clause (2) of
section 291c(e) of this title; and

1, 1944, ch. 373, title VI, § 625, as added Aug. 13, 1946, ch.
958, § 2, 60 Stat. 1041; amended Oct. 25, 1949, ch. 722,
§ 3(c), 63 Stat. 899, 901; July 12, 1954, ch. 471, § 4(b), 68
Stat. 464, prior to the general amendment of this subchapter by Pub. L. 88–443.
AMENDMENTS
1984—Pub. L. 98–369 amended section generally. Prior
to amendment, section read as follows: ‘‘If any facility
with respect to which funds have been paid under section 291f of this title shall, at any time within twenty
years after the completion of construction—
‘‘(a) be sold or transferred to any person, agency, or
organization (1) which is not qualified to file an application under section 291e of this title, or (2) which
is not approved as a transferee by the State agency
designated pursuant to section 291d of this title, or
its successor, or
‘‘(b) cease to be a public health center or a public
or other nonprofit hospital, outpatient facility, facility for long-term care, or rehabilitation facility, unless the Surgeon General determines, in accordance
with regulations, that there is good cause for releasing the applicant or other owner from this obligation,
the United States shall be entitled to recover from either the transferor or the transferee (or, in the case of
a facility which has ceased to be public or nonprofit,
from the owners thereof) an amount bearing the same
ratio to the then value (as determined by the agreement of the parties or by action brought in the district
court of the United States for the district in which the
facility is situated) of so much of the facility as constituted an approved project or projects, as the amount
of the Federal participation bore to the cost of the construction or modernization under such project or
projects. Such right of recovery shall not constitute a
lien upon said facility prior to judgment.’’
1970—Cl. (b). Pub. L. 91–296 substituted ‘‘outpatient
facility’’ for ‘‘diagnostic or treatment center’’.

(B) will meet the obligation of the facility
under clause (1) of section 291c(e) of this title.
(2) The Secretary may waive the recovery
rights of the United States under subsection
(a)(2) of this section with respect to a facility in
any State if the Secretary determines, in accordance with regulations, that there is good
cause for waiving such rights with respect to
such facility.
(e) Lien
The right of recovery of the United States
under subsection (a) of this section shall not
constitute a lien on any facility with respect to
which funds have been paid under section 291f of
this title.
(July 1, 1944, ch. 373, title VI, § 609, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 456; amended Pub. L. 91–296, title I § 116(d), June 30, 1970, 84
Stat. 342; Pub. L. 98–369, div. B, title III, § 2381(a),
July 18, 1984, 98 Stat. 1112.)
PRIOR PROVISIONS
A prior section 291i, act July 1, 1944, ch. 373, title VI,
§ 631, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended June 19, 1948, ch. 544, 62 Stat. 531; Oct. 25, 1949,
ch. 722, § 9, 63 Stat. 901; July 12, 1954, ch. 471, § 4(c)–(f),
68 Stat. 465, 466; Aug. 1, 1956, ch. 852, § 19(a), (b), 70 Stat.
911; June 25, 1959, Pub. L. 86–70, § 31(c), 73 Stat. 149; July
12, 1960, Pub. L. 86–624, § 29(d), 74 Stat. 419; Oct. 5, 1961,
Pub. L. 87–395, § 5, 75 Stat. 826; Sept. 25, 1962, Pub. L.
87–688, § 4(a)(2), 76 Stat. 587, related to allotment percentages, and contained various definitions, prior to
the general amendment of this subchapter by Pub. L.
88–443. See section 291b of this title.
Provisions similar to those comprising this section
were contained in section 291h(e) of this title, act July

Page 742

TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
REGULATIONS AND PERSONNEL
Section 2381(c) of Pub. L. 98–369 provided that: ‘‘Not
later than the expiration of the one-hundred-andeighty-day period beginning on the date of the enactment of this section [July 18, 1984], the Secretary shall
have in effect regulations and personnel to place in effect the amendments made by this section [amending
sections 291i and 300s–1a of this title].’’

§ 291j. Loans
(a) Authorization; conditions
In order further to assist the States in carrying out the purposes of this subchapter, the Surgeon General is authorized to make a loan of
funds to the applicant for any project for construction or modernization which meets all of
the conditions specified for a grant under this
part.
(b) Approval; payments to applicants
Except as provided in this section, an application for a loan with respect to any project under
this part shall be submitted, and shall be approved by the Surgeon General, in accordance
with the same procedures and subject to the
same limitations and conditions as would be ap-

Page 743

TITLE 42—THE PUBLIC HEALTH AND WELFARE

plicable to the making of a grant under this part
for such project. Any such application may be
approved in any fiscal year only if sufficient
funds are available from the allotment for the
type of project involved. All loans under this
section shall be paid directly to the applicant.
(c) Terms
(1) The amount of a loan under this part shall
not exceed an amount equal to the Federal share
of the estimated cost of construction or modernization under the project. Where a loan and a
grant are made under this part with respect to
the same project, the aggregate amount of such
loan and such grant shall not exceed an amount
equal to the Federal share of the estimated cost
of construction or modernization under the
project. Each loan shall bear interest at the rate
arrived at by adding one-quarter of 1 per centum
per annum to the rate which the Secretary of
the Treasury determines to be equal to the current average yield on all outstanding marketable obligations of the United States as of the
last day of the month preceding the date the application for the loan is approved and by adjusting the result so obtained to the nearest oneeighth of 1 per centum. Each loan made under
this part shall mature not more than forty years
after the date on which such loan is made, except that nothing in this part shall prohibit the
payment of all or part of the loan at any time
prior to the maturity date. In addition to the
terms and conditions provided for, each loan
under this part shall be made subject to such
terms, conditions, and covenants relating to repayment of principal, payment of interest, and
other matters as may be agreed upon by the applicant and the Surgeon General.
(2) The Surgeon General may enter into agreements modifying any of the terms and conditions of a loan made under this part whenever he
determines such action is necessary to protect
the financial interest of the United States.
(3) If, at any time before a loan for a project
has been repaid in full, any of the events specified in clause (a) or clause (b) of section 291i 1 of
this title occurs with respect to such project,
the unpaid balance of the loan shall become immediately due and payable by the applicant, and
any transferee of the facility shall be liable to
the United States for such repayment.
(d) Funds; miscellaneous receipts
Any loan under this part shall be made out of
the allotment from which a grant for the project
concerned would be made. Payments of interest
and repayments of principal on loans under this
part shall be deposited in the Treasury as miscellaneous receipts.
(July 1, 1944, ch. 373, title VI, § 610, as added Pub.
L. 88–443, § 3(a), Aug. 18, 1964, 78 Stat. 457.)
REFERENCES IN TEXT
Section 291i of this title, referred to in subsec. (c)(3),
was amended generally by Pub. L. 98–369, div. B, title
III, § 2381(a), July 18, 1984, 98 Stat. 1112, and, as so
amended, the provisions contained in former cls. (a)
and (b) of section 291i are covered by section 291i(a)(1)
and (2).
1 See

References in Text note below.

§ 291j–1

PRIOR PROVISIONS
A prior section 291j, act July 1, 1944, ch. 373, title VI,
§ 632, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended June 25, 1948, ch. 646, § 32(a), 62 Stat. 991; May
24, 1949, ch. 139, § 127, 63 Stat. 107; Oct. 25, 1949, ch. 722,
§ 4, 63 Stat. 900; July 12, 1954, ch. 471, § 4(g), 68 Stat. 466;
Aug. 28, 1958, Pub. L. 85–791, § 27, 72 Stat. 950, related to
withholding of certification for noncompliance with requirements, appeal, conclusiveness of findings, the jurisdiction of the courts of appeals and to review by the
Supreme Court, prior to the general amendment of this
subchapter by Pub. L. 88–443. See sections 291g and 291h
of this title.
Provisions similar to those comprising this section
were contained in sections 291w to 291z of this title,
prior to the general amendment of this subchapter by
Pub. L. 88–443.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

PART B—LOAN GUARANTEES AND LOANS FOR
MODERNIZATION AND CONSTRUCTION OF HOSPITALS AND OTHER MEDICAL FACILITIES
§ 291j–1. Loan guarantees and loans
(a) Authority of Secretary
(1) In order to assist nonprofit private agencies to carry out needed projects for the modernization or construction of nonprofit private
hospitals, facilities for long-term care, outpatient facilities, and rehabilitation facilities,
the Secretary, during the period July 1, 1970,
through June 30, 1974, may, in accordance with
the provisions of this part, guarantee to nonFederal lenders making loans to such agencies
for such projects, payment of principal of and
interest on loans, made by such lenders, which
are approved under this part.
(2) In order to assist public agencies to carry
out needed projects for the modernization or
construction of public health centers, and public
hospitals, facilities for long-term care, outpatient facilities, and rehabilitation facilities,
the Secretary, during the period July 1, 1970,
through June 30, 1974, may, in accordance with
the provisions of this part, make loans to such
agencies which shall be sold and guaranteed in
accordance with section 291j–7 of this title.
(b) Cost limitations
(1) No loan guarantee under this part with respect to any modernization or construction
project may apply to so much of the principal
amount thereof as, when added to the amount of
any grant or loan under part A of this subchapter with respect to such project, exceeds 90
per centum of the cost of such project.
(2) No loan to a public agency under this part
shall be made in an amount which, when added
to the amount of any grant or loan under part A
of this subchapter with respect to such project,
exceeds 90 per centum of the cost of such
project.
(c) Administrative assistance
The Secretary, with the consent of the Secretary of Housing and Urban Development, shall

§ 291j–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

obtain from the Department of Housing and
Urban Development such assistance with respect
to the administration of this part as will promote efficiency and economy thereof.
(July 1, 1944, ch. 373, title VI, § 621, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat. 344;
amended Pub. L. 93–45, title I, § 108(b)(1), June 18,
1973, 87 Stat. 93.)
AMENDMENTS
1973—Subsec. (a). Pub. L. 93–45 extended termination
date of guarantee and loan making period in pars. (1)
and (2) from June 30, 1973, to June 30, 1974.

§ 291j–2. Allocation among States
(a) Allotment regulations
For each fiscal year, the total amount of principal of loans to nonprofit private agencies
which may be guaranteed or loans to public
agencies which may be directly made under this
part shall be allotted by the Secretary among
the States, in accordance with regulations, on
the basis of each State’s relative population, financial need, need for construction of the facilities referred to in section 291j–1(a) of this title,
and need for modernization of such facilities.
(b) Reallotment
Any amount allotted under subsection (a) of
this section to a State for a fiscal year ending
before July 1, 1973, and remaining unobligated at
the end of such year shall remain available to
such State, for the purpose for which made, for
the next two fiscal years (and for such years
only), and any such amount shall be in addition
to the amounts allotted to such State for such
purpose for each of such next two fiscal years;
except that, with the consent of any such State,
any such amount remaining unobligated at the
end of the first of such next fiscal year may be
reallotted (on such basis as the Secretary deems
equitable and consistent with the purposes of
this subchapter) to other States which have
need therefor. Any amounts so reallotted to a
State shall be available for the purposes for
which made until the close of the second such
next two fiscal years and shall be in addition to
the amount allotted and available to such State
for the same period.
(c) Time of availability of amounts for subsequent allotment
Any amount allotted or reallotted to a State
under this section for a fiscal year shall not,
until the expiration of the period during which
it is available for obligation, be considered as
available for allotment for a subsequent fiscal
year.
(d) Modernization or construction commenced
on or after January 1, 1968
The allotments of any State under subsection
(a) of this section for the fiscal year ending June
30, 1971, and the succeeding fiscal year shall also
be available to guarantee loans with respect to
any project, for modernization or construction
of a nonprofit private hospital or other health
facility referred to in section 291j–1(a)(1) of this
title, if the modernization or construction of
such facility was not commenced earlier than
January 1, 1968, and if the State certifies and the

Page 744

Secretary finds that without such guaranteed
loan such facility could not be completed and
begin to operate or could not continue to operate, but with such guaranteed loan would be
able to do so: Provided, That this subsection
shall not apply to more than two projects in any
one State.
(July 1, 1944, ch. 373, title VI, § 622, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat.
345.)
§ 291j–3. Applications and conditions
(a) Contents of applications
For each project for which a guarantee of a
loan to a nonprofit private agency or a direct
loan to a public agency is sought under this
part, there shall be submitted to the Secretary,
through the State agency designated in accordance with section 291d of this title, an application by such private nonprofit agency or by such
public agency. If two or more private nonprofit
agencies, or two or more public agencies, join in
the project, the application may be filed by one
or more such agencies. Such application shall (1)
set forth all of the descriptions, plans, specifications, assurances, and information which are required by the third sentence of section 291e(a) of
this title (other than clause (6) thereof) with respect to applications submitted under that section, (2) contain such other information as the
Secretary may require to carry out the purposes
of this part, and (3) include a certification by
the State agency of the total cost of the project
and the amount of the loan for which a guarantee is sought under this part, or the amount of
the direct loan sought under this part, as the
case may be.
(b) Conditions for approval
The Secretary may approve such application
only if—
(1) there remains sufficient balance in the
allotment determined for such State pursuant
to section 291j–2 of this title to cover the
amount of the loan for which a guarantee is
sought, or the amount of the direct loan
sought (as the case may be), in such application,
(2) he makes each of the findings which are
required by clauses (1) through (4) of section
291e(b) of this title for the approval of applications for projects thereunder (except that, in
the case of the finding required under such
clause (4) of entitlement of a project to a priority established under section 291c(a) of this
title; such finding shall be made without regard to the provisions of clauses (1) and (3) of
such section),
(3) he finds that there is compliance with
section 291e(e) of this title,
(4) he obtains assurances that the applicant
will keep such records, and afford such access
thereto, and make such reports, in such form
and containing such information, as the Secretary may reasonably require, and
(5) he also determines, in the case of a loan
for which a guarantee is sought, that the
terms, conditions, maturity, security (if any),
and schedule and amounts of repayments with
respect to the loan are sufficient to protect

Page 745

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the financial interests of the United States
and are otherwise reasonable and in accord
with regulations, including a determination
that the rate of interest does not exceed such
per centum per annum on the principal obligation outstanding as the Secretary determines
to be reasonable, taking into account the
range of interest rates prevailing in the private market for similar loans and the risks assumed by the United States.
(c) Hearing
No application under this section shall be disapproved until the Secretary has afforded the
State agency an opportunity for a hearing.
(d) Amendment of approved applications
Amendment of an approved application shall
be subject to approval in the same manner as an
original application.
(e) Recovery rights; terms and conditions
(1) In the case of any loan to a nonprofit private agency, the United States shall be entitled
to recover from the applicant the amount of any
payments made pursuant to any guarantee of
such loan under this part, unless the Secretary
for good cause waives its right of recovery, and,
upon making any such payment, the United
States shall be subrogated to all of the rights of
the recipient of the payments with respect to
which the guarantee was made.
(2) Guarantees of loans to nonprofit private
agencies under this part shall be subject to such
further terms and conditions as the Secretary
determines to be necessary to assure that the
purposes of this part will be achieved, and, to
the extent permitted by subsection (f) of this
section, any of such terms and conditions may
be modified by the Secretary to the extent he
determines it to be consistent with the financial
interest of the United States.
(f) Incontestable guarantee
Any guarantee of a loan to a nonprofit private
agency made by the Secretary pursuant to this
part shall be incontestable in the hands of an
applicant on whose behalf such guarantee is
made, and as to any person who makes or contracts to make a loan to such applicant in reliance thereon, except for fraud or misrepresentation on the part of such applicant or such other
person.
(July 1, 1944, ch. 373, title VI, § 623, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat.
346.)
§ 291j–4. Payment of interest on guaranteed loans
(a) Subject to the provisions of subsection (b)
of this section, in the case of a guarantee of any
loan to a nonprofit private agency under this
part with respect to a hospital or other medical
facility, the Secretary shall pay, to the holder of
such loan and for and on behalf of such hospital
or other medical facility amounts sufficient to
reduce by 3 per centum per annum the net effective interest rate otherwise payable on such
loan. Each holder of a loan, to a nonprofit private agency, which is guaranteed under this part
shall have a contractual right to receive from
the United States interest payments required by
the preceding sentence.

§ 291j–6

(b) Contracts to make the payments provided
for in this section shall not carry an aggregate
amount greater than such amount as may be
provided in appropriations Acts.
(July 1, 1944, ch. 373, title VI, § 624, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat.
347.)
§ 291j–5. Limitation on amounts of loans guaranteed or directly made
The cumulative total of the principal of the
loans outstanding at any time with respect to
which guarantees have been issued, or which
have been directly made, under this part may
not exceed the lesser of—
(1) such limitations as may be specified in
appropriations Acts, or
(2) in the case of loans covered by allotments
for the fiscal year ending June 30, 1971,
$500,000,000; for the fiscal year ending June 30,
1972, $1,000,000,000; and for each of the fiscal
years ending June 30, 1973, and June 30, 1974,
$1,500,000,000.
(July 1, 1944, ch. 373, title VI, § 625, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat. 347;
amended Pub. L. 93–45, title I, § 108(b)(2), June 18,
1973, 87 Stat. 93.)
AMENDMENTS
1973—Pub. L. 93–45 provided for a limitation of
$1,500,000,000 on amount of loans outstanding in the
case of loans covered by allotments for fiscal year ending June 30, 1974.

§ 291j–6. Loan guarantee and loan fund
(a)(1) There is hereby established in the Treasury a loan guarantee and loan fund (hereinafter
in this section referred to as the ‘‘fund’’) which
shall be available to the Secretary without fiscal year limitation, in such amounts as may be
specified from time to time in appropriations
Acts, (i) to enable him to discharge his responsibilities under guarantees issued by him under
this part, (ii) for payment of interest on the
loans to nonprofit agencies which are guaranteed, (iii) for direct loans to public agencies
which are sold and guaranteed, (iv) for payment
of interest with respect to such loans, and (v) for
repurchase by him of direct loans to public
agencies which have been sold and guaranteed.
There are authorized to be appropriated to the
fund from time to time such amounts as may be
necessary to provide capital required for the
fund. To the extent authorized from time to
time in appropriation Acts, there shall be deposited in the fund amounts received by the Secretary as interest payments or repayments of
principal on loans and any other moneys, property, or assets derived by him from his operations under this part, including any moneys derived from the sale of assets.
(2) Of the moneys in the fund, there shall be
available to the Secretary for the purpose of
making of direct loans to public agencies only
such sums as shall have been appropriated for
such purpose pursuant to section 291j–7 of this
title or sums received by the Secretary from the
sale of such loans (in accordance with such section) and authorized in appropriations Acts to
be used for such purpose.

§ 291j–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) If at any time the moneys in the fund are
insufficient to enable the Secretary to discharge
his responsibilities under this part—
(i) to make payments of interest on loans to
nonprofit private agencies which he has guaranteed under this part;
(ii) to otherwise comply with guarantees
under this part of loans to nonprofit private
agencies;
(iii) to make payments of interest subsidies
with respect to loans to public agencies which
he has made, sold, and guaranteed under this
part;
(iv) in the event of default by public agencies to make payments of principal and interest on loans which the Secretary has made,
sold, and guaranteed, under this part, to make
such payments to the purchaser of such loan;
(v) to repurchase loans to public agencies
which have been sold and guaranteed under
this part,
he is authorized to issue to the Secretary of the
Treasury notes or other obligations in such
forms and denominations, bearing such maturities, and subject to such terms and conditions,
as may be prescribed by the Secretary with the
approval of the Secretary of the Treasury, but
only in such amounts as may be specified from
time to time in appropriations Acts. Such notes
or other obligations shall bear interest at a rate
determined by the Secretary of the Treasury,
taking into consideration the current average
market yield on outstanding marketable obligations of the United States of comparable maturities during the month preceding the issuance
of the notes or other obligations. The Secretary
of the Treasury is authorized and directed to
purchase any notes and other obligations issued
hereunder and for that purpose he is authorized
to use as a public debt transaction the proceeds
from the sale of any securities issued under
chapter 31 of title 31, and the purposes for which
securities may be issued under that chapter, are
extended to include any purchase of such notes
and obligations. The Secretary of the Treasury
may at any time sell any of the notes or other
obligations acquired by him under this subsection. All redemptions, purchases, and sales
by the Secretary of the Treasury of such notes
or other obligations shall be treated as public
debt transactions of the United States. Sums
borrowed under this subsection shall be deposited in the fund and redemption of such notes
and obligations shall be made by the Secretary
from such fund.
(July 1, 1944, ch. 373, title VI, § 626, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat.
347.)
CODIFICATION
In subsec. (b), ‘‘chapter 31 of title 31’’ and ‘‘that chapter’’ substituted for ‘‘the Second Liberty Bond Act, as
amended’’ and ‘‘that Act, as amended’’, respectively, on
authority of Pub. L. 97–258, § 4(b), Sept. 13, 1982, 96 Stat.
1067, the first section of which enacted Title 31, Money
and Finance.

§ 291j–7. Loans to public facilities
(a) Interest rates; security; equitable geographical distribution
(1) Any loan made by the Secretary to a public
agency under this part for the modernization or

Page 746

construction of a public hospital or other health
facility shall require such public agency to pay
interest thereon at a rate comparable to the
current rate of interest prevailing with respect
to loans, to nonprofit private agencies, which
are guaranteed under this part, for the modernization or construction of similar facilities in
the same or similar areas, minus 3 per centum
per annum.
(2)(A) No loan to a public agency shall be made
under this part unless—
(i) the Secretary is reasonably satisfied that
such agency will be able to make payments of
principal and interest thereon when due, and
(ii) such agency provides the Secretary with
reasonable assurances that there will be available to such agency such additional funds as
may be necessary to complete the project with
respect to which such loan is requested.
(B) Any loan to a public agency shall have
such security, have such maturity date, be repayable in such installments, and be subject to
such other terms and conditions (including provision for recovery in case of default) as the Secretary determines to be necessary to carry out
the purposes of this part while adequately protecting the financial interests of the United
States.
(3) In making loans to public agencies under
this part, the Secretary shall give due regard to
achieving an equitable geographical distribution
of such loans.
(b) Sale
(1) The Secretary shall from time to time, but
with due regard to the financial interests of the
United States, sell loans referred to in subsection (a)(1) of this section either on the private market or to the Federal National Mortgage Association in accordance with section 1717
of title 12.
(2) Any loan so sold shall be sold for an
amount which is equal (or approximately equal)
to the amount of the unpaid principal of such
loan as of the time of sale.
(c) Agreements
(1) The Secretary is authorized to enter into
an agreement with the purchaser of any loan
sold under this part under which the Secretary
agrees—
(A) to guarantee to such purchaser (and any
successor in interest to such purchaser) payment of the principal and interest payable
under such loan, and
(B) to pay as an interest subsidy to such purchaser (and any successor in interest of such
purchaser) amounts which when added to the
amount of interest payable on such loan, are
equivalent to a reasonable rate of interest on
such loan as determined by the Secretary,
after taking into account the range of prevailing interest rates in the private market on
similar loans and the risks assumed by the
United States.
(2) Any such agreement—
(A) may provide that the Secretary shall act
as agent of any such purchaser, for the purpose of collecting from the public agency to
which such loan was made and paying over to
such purchaser, any payments of principal and

Page 747

TITLE 42—THE PUBLIC HEALTH AND WELFARE

interest payable by such agency under such
loan;
(B) may provide for the repurchase by the
Secretary of any such loan on such terms and
conditions as may be specified in the agreement;
(C) shall provide that, in the event of any default by the public agency to which such loan
was made in payment of principal and interest
due on such loan, the Secretary shall, upon notification to the purchaser (or to the successor
in interest of such purchaser), have the option
to close out such loan (and any obligations of
the Secretary with respect thereto) by paying
to the purchaser (or his successor in interest)
the total amount of outstanding principal and
interest due thereon at the time of such notification; and
(D) shall provide that, in the event such loan
is closed out as provided in subparagraph (C),
or in the event of any other loss incurred by
the Secretary by reason of the failure of such
public agency to make payments of principal
and interest on such loan, the Secretary shall
be subrogated to all rights of such purchaser
for recovery of such loss from such public
agency.
(d) Right of recovery; waiver
The Secretary may, for good cause, waive any
right of recovery which he has against a public
agency by reason of the failure of such agency
to make payments of principal and interest on a
loan made to such agency under this part.
(e) Interest and interest subsidies as gross income under Internal Revenue Code
After any loan to a public agency under this
part has been sold and guaranteed, interest paid
on such loan and any interest subsidy paid by
the Secretary with respect to such loan which is
received by the purchaser thereof (or his successor in interest) shall be included in gross income
for the purposes of chapter 1 of title 26.
(f) Sales proceeds; deposit and use
Amounts received by the Secretary as proceeds from the sale of loans under this section
shall be deposited in the loan fund established
by section 291j–6 of this title, and shall be available to the Secretary for the making of further
loans under this part in accordance with the
provisions of subsection (a)(2) of such section.
(g) Authorization of appropriations
There is authorized to be appropriated to the
Secretary, for deposit in the loan fund established by section 291j–6 of this title, $30,000,000 to
provide initial capital for the making of direct
loans by the Secretary to public agencies for the
modernization or construction of facilities referred to in subsection (a)(1) of this section.
(July 1, 1944, ch. 373, title VI, § 627, as added Pub.
L. 91–296, title II, § 201, June 30, 1970, 84 Stat. 349;
amended Pub. L. 99–514, § 2, Oct. 22, 1986, 100
Stat. 2095.)
AMENDMENTS
1986—Subsec. (e). Pub. L. 99–514 substituted ‘‘Internal
Revenue Code of 1986’’ for ‘‘Internal Revenue Code of
1954’’, which for purposes of codification was translated
as ‘‘title 26’’ thus requiring no change in text.

§ 291j–10

COMMITMENTS FOR DIRECT LOANS TO PUBLIC AGENCIES
Pub. L. 91–667, title II, § 200, Jan. 11, 1971, 84 Stat. 2007,
provided: ‘‘That the Secretary is authorized to issue
commitments for direct loans to public agencies in accordance with section 627 of the Public Health Service
Act [this section] which shall constitute contractual
obligations of the United States, the total of such outstanding commitments not to exceed $30,000,000 at any
given time; to sell obligations received pursuant to
such commitments as provided in section 627, and the
proceeds of any such sale shall be used to make a direct
loan pursuant to the outstanding commitment under
which the obligations were received.’’

PART C—CONSTRUCTION OR MODERNIZATION OF
EMERGENCY ROOMS
§ 291j–8. Authorization of appropriations
In order to assist in the provision of adequate
emergency room service in various communities
of the Nation for treatment of accident victims
and handling of other medical emergencies
through special project grants for the construction or modernization of emergency rooms of
general hospitals, there are authorized to be appropriated $20,000,000 each for the fiscal year
ending June 30, 1971, and the next two fiscal
years.
(July 1, 1944, ch. 373, title VI, § 631, as added Pub.
L. 91–296, title III, § 301, June 30, 1970, 84 Stat.
351.)
§ 291j–9. Eligibility for grants
Funds appropriated pursuant to section 291j–8
of this title shall be available for grants by the
Secretary for not to exceed 50 per centum of the
cost of construction or modernization of emergency rooms of public or nonprofit general hospitals, including provision or replacement of
medical transportation facilities. Such grants
shall be made by the Secretary only after consultation with the State agency designated in
accordance with section 291d(a)(1) of this title.
In order to be eligible for a grant under this
part, the project, and the applicant therefor,
must meet such criteria as may be prescribed by
regulations. Such regulations shall be so designed as to provide aid only with respect to
projects for which adequate assistance is not
readily available from other Federal, State,
local, or other sources, and to assist in providing
modern, efficient, and effective emergency room
service needed to care for victims of highway,
industrial, agricultural, or other accidents and
to handle other medical emergencies, and to assist in providing such service in geographical
areas which have special need therefor.
(July 1, 1944, ch. 373, title VI, § 632, as added Pub.
L. 91–296, title III, § 301, June 30, 1970, 84 Stat.
351.)
§ 291j–10. Payments
Grants under this part shall be paid in advance
or by way of reimbursement, in such installments and on such conditions, as in the judgment of the Secretary will best carry out the
purposes of this part.
(July 1, 1944, ch. 373, title VI, § 633, as added Pub.
L. 91–296, title III, § 301, June 30, 1970, 84 Stat.
351.)

§ 291k

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PART D—GENERAL PROVISIONS

§ 291k. Federal Hospital Council
(a) Membership; qualifications
In administering this subchapter, the Surgeon
General shall consult with a Federal Hospital
Council consisting of the Surgeon General, who
shall serve as Chairman ex officio, and twelve
members appointed by the Secretary of Health
and Human Services. Six of the twelve appointed members shall be persons who are outstanding in fields pertaining to medical facility
and health activities, and three of these six
shall be authorities in matters relating to the
operation of hospitals or other medical facilities, one of them shall be an authority in matters relating to individuals with intellectual disabilities, and one of them shall be an authority
in matters relating to mental health, and the
other six members shall be appointed to represent the consumers of the services provided by
such facilities and shall be persons familiar with
the need for such services in urban or rural
areas.
(b) Term of membership
Each appointed member shall hold office for a
term of four years, except that any member appointed to fill a vacancy occurring prior to the
expiration of the term for which his predecessor
was appointed shall be appointed for the remainder of such term. An appointed member shall
not be eligible to serve continuously for more
than two terms (whether beginning before or
after August 18, 1964) but shall be eligible for reappointment if he has not served immediately
preceding his reappointment.
(c) Meetings; annual or by call of Surgeon General
The Council shall meet as frequently as the
Surgeon General deems necessary, but not less
than once each year. Upon request by three or
more members, it shall be the duty of the Surgeon General to call a meeting of the Council.
(d) Advisory or technical committees
The Council is authorized to appoint such special advisory or technical committees as may be
useful in carrying out its functions.
(July 1, 1944, ch. 373, title VI, § 641, formerly § 621,
as added Pub. L. 88–443, § 3(a), Aug. 18, 1964, 78
Stat. 458, renumbered § 641, Pub. L. 91–296, title
II, § 201, June 30, 1970, 84 Stat. 344; amended Pub.
L. 91–515, title VI, § 601(b)(2), Oct. 30, 1970, 84
Stat. 1311; Pub. L. 96–88, title V, § 509(b), Oct. 17,
1979, 93 Stat. 695; Pub. L. 111–256, § 2(f)(4), Oct. 5,
2010, 124 Stat. 2644.)

Page 748

1970—Subsec. (e). Pub. L. 91–515 struck out subsec. (e)
which related to payment of compensation and travel
expenses of appointed Council members and members of
advisory or technical committees while serving on
Council business.
TRANSFER OF FUNCTIONS
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a) pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20.
TERMS OF FEDERAL HOSPITAL COUNCIL MEMBERS
Section 3(b)(3) of Pub. L. 88–443 providing that the
terms of members serving on the Council prior to Aug.
18, 1964, shall expire on the date they would have expired had Pub. L. 88–443 not been enacted, is set out as
an Effective Date note under section 291 of this title.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
DEFINITIONS
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 291l. Conference of State agencies
Whenever in his opinion the purposes of this
subchapter would be promoted by a conference,
the Surgeon General may invite representatives
of as many State agencies, designated in accordance with section 291d of this title, to confer as
he deems necessary or proper. A conference of
the representatives of all such State agencies
shall be called annually by the Surgeon General.
Upon the application of five or more of such
State agencies, it shall be the duty of the Surgeon General to call a conference of representatives of all State agencies joining in the request.
(July 1, 1944, ch. 373, title VI, § 642, formerly § 622,
as added Pub. L. 88–443, § 3(a), Aug. 18, 1964, 78
Stat. 458, and renumbered § 642, Pub. L. 91–296,
title II, § 201, June 30, 1970, 84 Stat. 344.)

PRIOR PROVISIONS

PRIOR PROVISIONS

Provisions similar to those comprising this section
were contained in subsec. (b) of a prior section 291k, act
July 1, 1944, ch. 373, title VI, § 633, as added Aug. 13, 1946,
ch. 958, § 2, 60 Stat. 1041; amended June 24, 1948, ch. 621,
§ 6(b), 62 Stat. 602; 1953 Reorg. Plan No. 1, §§ 5, 8, eff. Apr.
11, 1953, 18 F.R. 2053, 67 Stat. 631, prior to the general
amendment of this subchapter by Pub. L. 88–443.

A prior section 291l, act July 1, 1944, ch. 373, title VI,
§ 634, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041,
contained provisions similar to this section, prior to
the general amendment of this subchapter by Pub. L.
88–443.

AMENDMENTS
2010—Subsec. (a). Pub. L. 111–256 substituted ‘‘matters
relating to individuals with intellectual disabilities’’
for ‘‘matters relating to the mentally retarded’’.

TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under sec-

Page 749

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 291o

tion 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.

81 Stat. 541, and renumbered § 643A, Pub. L.
91–296, title II, § 201, June 30, 1970, 84 Stat. 344.)

§ 291m. State control of operations

Section 291n of this title, referred to in subsec. (a),
was repealed by Pub. L. 90–174, § 3(b)(1), Dec. 5, 1967, 81
Stat. 535.

Except as otherwise specifically provided,
nothing in this subchapter shall be construed as
conferring on any Federal officer or employee
the right to exercise any supervision or control
over the administration, personnel, maintenance, or operation of any facility with respect
to which any funds have been or may be expended under this subchapter.
(July 1, 1944, ch. 373, title VI, § 643, formerly § 623,
as added Pub. L. 88–443, § 3(a), Aug. 18, 1964, 78
Stat. 458, and renumbered § 643, Pub. L. 91–296,
title II, § 201, June 30, 1970, 84 Stat. 344.)
PRIOR PROVISIONS
A prior section 291m, act July 1, 1944, ch. 373, title VI,
§ 635, as added Aug. 13, 1946, ch. 958, § 2, 60 Stat. 1041;
amended July 12, 1954, ch. 471, § 4(h), 68 Stat. 467, contained provisions similar to this section, prior to the
general amendment of this subchapter by Pub. L.
88–443.

§ 291m–1. Loans for certain hospital experimentation projects
(a) Other public or private sources unavailable
for alleviation of hardship due to increased
construction costs
In order to alleviate hardship on any recipient
of a grant under section 291n 1 of this title (as in
effect immediately before August 18, 1964) for a
project for the construction of an experimental
or demonstration facility having as its specific
purpose the application of novel means for the
reduction of hospital costs with respect to which
there has been a substantial increase in the cost
of such construction (over the estimated cost of
such project on the basis of which such grant
was made) through no fault of such recipient,
the Secretary is authorized to make a loan to
such recipient not exceeding 662⁄3 per centum of
such increased costs, as determined by the Secretary, if the Secretary determines that such recipient is unable to obtain such an amount for
such purpose from other public or private
sources.
(b) Application; form; information
Any such loan shall be made only on the basis
of an application submitted to the Secretary in
such form and containing such information and
assurances as he may prescribe.
(c) Interest; repayment period
Each such loan shall bear interest at the rate
of 21⁄2 per centum per annum on the unpaid balance thereof and shall be repayable over a period
determined by the Secretary to be appropriate,
but not exceeding fifty years.
(d) Authorization of appropriation
There are hereby authorized to be appropriated $3,500,000 to carry out the provisions of
this section.
(July 1, 1944, ch. 373, title VI, § 643A, formerly
§ 623A, as added Pub. L. 90–174, § 11, Dec. 5, 1967,
1 See

References in Text note below.

REFERENCES IN TEXT

§ 291n. Repealed. Pub. L. 90–174, § 3(b)(1), Dec. 5,
1967, 81 Stat. 535
Section, act July 1, 1944, ch. 373, title VI, § 644, formerly § 624, as added Aug. 18, 1964, Pub. L. 88–443, § 3(a),
78 Stat. 459, and renumbered § 644, June 30, 1970, Pub. L.
91–296, title II, § 201, 84 Stat. 344, provided for research,
experiments and demonstrations in utilization of medical facilities, authorization, grants-in-aid, amounts,
payment, conditions, authorization of appropriations,
and right of recovery of United States Government. See
section 242b of this title.
Provisions similar to those comprising this section
were contained in a prior section 291n, act July 1, 1944,
ch. 373, title VI, § 636, as added Oct. 25, 1949, ch. 722, § 5,
63 Stat. 900; amended Oct. 6, 1961, Pub. L. 87–395, § 4, 75
Stat. 825, prior to the general amendment of this subchapter by Pub. L. 88–443.
EFFECTIVE DATE OF REPEAL
Repeal effective with respect to appropriations for
fiscal year ending after June 30, 1967, see section 3(b) of
Pub. L. 90–174, set out as an Effective Date of 1967
Amendment note under section 246 of this title.

§ 291n–1. Omitted
CODIFICATION
Section, act July 1, 1944, ch. 373, title VI, § 637, formerly § 654(c), as added July 12, 1954, ch. 471, § 3, 68 Stat.
463; renumbered § 637 and amended Aug. 14, 1959, Pub. L.
86–158, title II, § 201, 73 Stat. 349, related to transfers of
allotments between States, prior to the general amendment of this subchapter by Pub. L. 88–443, Aug. 18, 1964,
78 Stat. 447. See section 291b of this title.

§ 291o. Definitions
For the purposes of this subchapter—
(a) The term ‘‘State’’ includes the Commonwealth of Puerto Rico, Guam, American Samoa,
the Trust Territory of the Pacific Islands, the
Virgin Islands, and the District of Columbia.
(b)(1) The term ‘‘Federal share’’ with respect
to any project means the proportion of the cost
of such project to be paid by the Federal Government under this subchapter.
(2) With respect to any project in any State for
which a grant is made from an allotment from
an appropriation under section 291a of this title,
the Federal share shall be the amount determined by the State agency designated in accordance with section 291d of this title, but not more
than 662⁄3 per centum or the State’s allotment
percentage, whichever is the lower, except that,
if the State’s allotment percentage is lower than
50 per centum, such allotment percentage shall
be deemed to be 50 per centum for purposes of
this paragraph.
(3) Prior to the approval of the first project in
a State during any fiscal year the State agency
designated in accordance with section 291d of
this title shall give the Secretary written notification of the maximum Federal share established pursuant to paragraph (2) of this subsection for projects in such State to be approved
by the Secretary during such fiscal year and the
method for determining the actual Federal

§ 291o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

share to be paid with respect to such projects;
and such maximum Federal share and such
method of determination for projects in such
State approved during such fiscal year shall not
be changed after such approval.
(4) Notwithstanding the provisions of paragraphs (2) and (3) of this subsection, the Federal
share shall, at the option of the State agency, be
equal to the per centum provided under such
paragraphs plus an incentive per centum (which
when combined with the per centum provided
under such paragraphs shall not exceed 90 per
centum) specified by the State agency in the
case of (A) projects that will provide services
primarily for persons in an area determined by
the Secretary to be a rural or urban poverty
area, and (B) projects that offer potential for reducing health care costs through shared services
among health care facilities, through interfacility cooperation, or through the construction or modernization of free-standing outpatient facilities.
(c) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related facilities, such as laboratories, outpatient
departments, nurses’ home facilities, extended
care facilities, facilities related to programs for
home health services, self-care units, and central service facilities, operated in connection
with hospitals, and also includes education or
training facilities for health professions personnel operated as an integral part of a hospital,
but does not include any hospital furnishing primarily domiciliary care.
(d) The term ‘‘public health center’’ means a
publicly owned facility for the provision of public health services, including related publicly
owned facilities such as laboratories, clinics,
and administrative offices operated in connection with such a facility.
(e) The term ‘‘nonprofit’’ as applied to any facility means a facility which is owned and operated by one or more nonprofit corporations or
associations no part of the net earnings of which
inures, or may lawfully inure, to the benefit of
any private shareholder or individual.
(f) The term ‘‘outpatient facility’’ means a facility (located in or apart from a hospital) for
the diagnosis or diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
(1) which is operated in connection with a
hospital, or
(2) in which patient care is under the professional supervision of persons licensed to practice medicine or surgery in the State, or, in
the case of dental diagnosis or treatment,
under the professional supervision of persons
licensed to practice dentistry in the State; or
(3) which offers to patients not requiring
hospitalization the services of licensed physicians in various medical specialties, and which
provides to its patients a reasonably full-range
of diagnostic and treatment services.
(g) The term ‘‘rehabilitation facility’’ means a
facility which is operated for the primary purpose of assisting in the rehabilitation of disabled
persons through an integrated program of—
(1) medical evaluation and services, and
(2) psychological, social, or vocational evaluation and services,

Page 750

under competent professional supervision, and
in the case of which—
(3) the major portion of the required evaluation and services is furnished within the facility; and
(4) either (A) the facility is operated in connection with a hospital, or (B) all medical and
related health services are prescribed by, or
are under the general direction of, persons licensed to practice medicine or surgery in the
State.
(h) The term ‘‘facility for long-term care’’
means a facility (including an extended care facility) providing in-patient care for convalescent or chronic disease patients who require
skilled nursing care and related medical services—
(1) which is a hospital (other than a hospital
primarily for the care and treatment of mentally ill or tuberculosis patients) or is operated in connection with a hospital, or
(2) in which such nursing care and medical
services are prescribed by, or are performed
under the general direction of, persons licensed to practice medicine or surgery in the
State.
(i) The term ‘‘construction’’ includes construction of new buildings, expansion, remodeling,
and alteration of existing buildings, and initial
equipment of any such buildings (including medical transportation facilities) and, in any case in
which it will help to provide a service not previously provided in the community, equipment
of any buildings; including architects’ fees, but
excluding the cost of off-site improvements and,
except with respect to public health centers, the
cost of the acquisition of land.
(j) The term ‘‘cost’’ as applied to construction
or modernization means the amount found by
the Surgeon General to be necessary for construction and modernization respectively, under
a project, except that such term, as applied to a
project for modernization of a facility for which
a grant or loan is to be made from an allotment
under section 291b(a)(2) of this title, does not include any amount found by the Surgeon General
to be attributable to expansion of the bed capacity of such facility.
(k) The term ‘‘modernization’’ includes alteration, major repair (to the extent permitted by
regulations), remodeling, replacement, and renovation of existing buildings (including initial
equipment thereof), and replacement of obsolete, built-in (as determined in accordance with
regulations) equipment of existing buildings.
(l) The term ‘‘title’’, when used with reference
to a site for a project, means a fee simple, or
such other estate or interest (including a leasehold on which the rental does not exceed 4 per
centum of the value of the land) as the Surgeon
General finds sufficient to assure for a period of
not less than fifty years’ undisturbed use and
possession for the purposes of construction and
operation of the project.
(July 1, 1944, ch. 373, title VI, § 645, formerly § 625,
as added Pub. L. 88–443, § 3(a), Aug. 18, 1964, 78
Stat. 460; amended Pub. L. 88–581, § 3(b), Sept. 4,
1964, 78 Stat. 919; renumbered § 645 and amended
Pub. L. 91–296, title I, §§ 113, 114(a), 116(f), 117, 118,
119(d), title II, § 201, June 30, 1970, 84 Stat. 340,
341, 342, 343, 344.)

Page 751

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 291o, act July 1, 1944, ch. 373, title VI,
§ 641, as added July 12, 1954, ch. 471, § 2, 68 Stat. 461, related to a declaration of purpose with respect to diagnostic or treatment centers, chronic disease hospitals,
rehabilitation facilities, and nursing homes, prior to
the general amendment of this subchapter by Pub. L.
88–443. See section 291 of this title.
Provisions similar to those comprising this section
were contained in section 291i(d) to (o), act July 1, 1944,
ch. 373, title VI, § 631, as added Aug. 13, 1946, ch. 958, § 2,
60 Stat. 1041; amended June 19, 1948, ch. 544, § 1(b), 62
Stat. 531; Oct. 25, 1949, ch. 722, § 9, 63 Stat. 901; July 12,
1954, ch. 471, § 4(c) to (f), 68 Stat. 465, 466; Aug. 1, 1956,
ch. 852, § 19(b), 70 Stat. 911; June 25, 1959, Pub. L. 86–70,
§ 31(c), 73 Stat. 149; July 12, 1960, Pub. L. 86–624, § 29(d),
74 Stat. 419; Oct. 5, 1961, Pub. L. 87–395, § 5, 75 Stat. 826;
Sept. 25, 1962, Pub. L. 87–688, § 4(a)(2), 76 Stat. 587, prior
to the general amendment of this subchapter by Pub.
L. 88–443.
AMENDMENTS
1970—Subsec. (a). Pub. L. 91–296, § 119(d), inserted reference to Trust Territory of the Pacific Islands.
Subsec. (b). Pub. L. 91–296, § 113, provided that Federal
share of any project be in such amount, not in excess
of two-thirds, as the State agency determined and authorized a higher Federal share of up to 90 per centum,
in case of rural or urban poverty projects, and facilities
which might reduce health costs through shared services, interfacility cooperation, and free-standing ambulatory care centers.
Subsec. (c). Pub. L. 91–296, § 114(a), inserted references
to extended care facilities, facilities related to programs for home health services, and self-care units operated in connection with hospitals and education or
training facilities for health professions personnel operated as an integral part of a hospital.
Subsec. (f). Pub. L. 91–296, § 116(f), substituted ‘‘outpatient facility’’ for ‘‘diagnostic or treatment center’’,
inserted ‘‘(located in or apart from a hospital)’’ after
‘‘means at facility’’, inserted ‘‘(including ambulatory
inpatients)’’ after ‘‘ambulatory patients’’, and added
par. (3).
Subsec. (h). Pub. L. 91–296, § 117, inserted ‘‘(including
an extended care facility)’’ after ‘‘means a facility’’.
Subsec. (i). Pub. L. 91–296, § 118, inserted reference to
equipment of any buildings in cases in which such
equipment will help to provide a service not previously
provided in the community.
1964—Subsec. (c). Pub. L. 88–581 substituted ‘‘nurses’
home facilities’’ for ‘‘nurses’ home and training facilities’’.

§ 291o–1

under part A of this subchapter for fiscal years ending
after June 30, 1970, and with respect to loan guarantees
and loans under part B of this subchapter made after
June 30, 1970, see section 119(e) of Pub. L. 91–296, set out
as a note under section 291b of this title.
EFFECTIVE DATE OF 1964 AMENDMENT
Amendment by Pub. L. 88–581 effective with respect
to applications for grants from appropriations for fiscal
years beginning after June 30, 1965, see section 3(b) of
Pub. L. 88–581, set out as a note under section 291c of
this title.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.

§ 291o–1. Financial statements
In the case of any facility for which a grant,
loan, or loan guarantee has been made under
this subchapter, the applicant for such grant,
loan, or loan guarantee (or, if appropriate, such
other person as the Secretary may prescribe)
shall file at least annually with the State agency for the State in which the facility is located
a statement which shall be in such form, and
contain such information, as the Secretary may
require to accurately show—
(1) the financial operations of the facility,
and
(2) the costs to the facility of providing
health services in the facility and the charges
made by the facility for providing such services,
during the period with respect to which the
statement is filed.

EFFECTIVE DATE OF 1970 AMENDMENT

(July 1, 1944, ch. 373, title VI, § 646, as added Pub.
L. 91–296, title I, § 121, June 30, 1970, 84 Stat. 343.)

Section 113 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
projects approved under this subchapter after June 30,
1970.
Section 114(a) of Pub. L. 91–296 provided that the
amendment made by that section is effective with respect to applications approved under this subchapter
after June 30, 1970.
Section 116(g) of Pub. L. 91–296 provided that: ‘‘The
amendments made by subsection (e) [amending this
section] and paragraphs (2) and (3) of subsection (f) of
this section [amending section 291e of this title] shall
apply with respect to applications approved under title
VI of such Act [this subchapter] after June 30, 1970.’’
Section 117 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
applications approved under this subchapter after June
30, 1970.
Section 118 of Pub. L. 91–296 provided that the amendment made by that section is effective with respect to
projects approved under this subchapter after June 30,
1970.
Amendment by section 119(d) of Pub. L. 91–296 applicable with respect to allotments and grants therefrom

Sections 291p to 291z were omitted in the general
amendment of this subchapter by Pub. L. 88–443, Aug.
18, 1964, 78 Stat. 447.
Section 291p, act July 1, 1944, ch. 373, title VI, § 646, as
added July 12, 1954, ch. 471, § 2, 68 Stat. 461, related to
appropriations to States for carrying out purposes of
section 291o(a) of this title.
Section 291q, act July 1, 1944, ch. 373, title VI, § 647, as
added July 12, 1954, ch. 471, § 2, 68 Stat. 461, related to
State application for funds for carrying out purposes of
section 291o(a) of this title.
Section 291r, act July 1, 1944, ch. 373, title VI, § 648, as
added July 12, 1954, ch. 471, § 2, 68 Stat. 462, related to
allotments to States of appropriations made pursuant
to section 291p of this title.
Section 291s, act July 1, 1944, ch. 373, title VI, § 651, as
added July 12, 1954, ch. 471, § 3, 68 Stat. 462; amended
Aug. 2, 1956, ch. 871, title IV, § 402, 70 Stat. 929; Aug. 14,
1958, Pub. L. 85–664, § 1(b), 72 Stat. 616; Oct. 5, 1961, Pub.
L. 87–395, § 3(a), 75 Stat. 825, related to appropriations
for assistance to States in carrying out purposes of section 291o(b) of this title.

PRIOR PROVISIONS

§ 292

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 291t, act July 1, 1944, ch. 373, title VI, 652, as
added July 12, 1954, ch. 471, § 3, 68 Stat. 462; amended
Aug. 1, 1956, ch. 852, § 19(c), 70 Stat. 911; Oct. 5, 1961, Pub.
L. 87–395, § 3(b), 75 Stat. 825; Sept. 25, 1962, Pub. L.
87–688, § 4(a)(3), 76 Stat. 587, related to allotments to
States of sums appropriated under section 291s of this
title.
Section 291u, act July 1, 1944, ch. 373, title VI, § 653, as
added July 12, 1954, ch. 471, § 3, 68 Stat. 463, related to
revision of regulations and State plans to cover benefits of sections 291s to 291v of this title.
Section 291v, act July 1, 1944, ch. 373, title VI, § 654, as
added July 12, 1954, ch. 471, § 3, 68 Stat. 463; amended
Aug. 14, 1959, Pub. L. 86–158, title II, § 201, 73 Stat. 349,
related to applications and payments for projects under
sections 291s to 291v of this title.
Section 291w, act July 1, 1944, ch. 373, title VI, § 661,
as added Aug. 1, 1958, Pub. L. 85–589, 72 Stat. 489; amended Oct. 5, 1961, Pub. L. 87–395, § 6, 75 Stat. 826, related to
an authorization of Surgeon General to make loans for
construction.
Section 291x, act July 1, 1944, ch. 373, title VI, § 662, as
added Aug. 1, 1958, Pub. L. 85–589, 72 Stat. 489, related
to approval of construction loans by Surgeon General.
Section 291y, act July 1, 1944, ch. 373, title VI, § 663, as
added Aug. 1, 1958, Pub. L. 85–589, 72 Stat. 489, related
to terms of the loans with respect to sections 291w to
291z of this title.
Section 291z, act July 1, 1944, ch. 373, title VI, § 664, as
added Aug. 1, 1958, Pub. L. 85–589, 72 Stat. 490, related
to allotment of funds for loans under this subchapter.

SUBCHAPTER V—HEALTH PROFESSIONS
EDUCATION
PART A—STUDENT LOANS
SUBPART I—INSURED HEALTH EDUCATION
ASSISTANCE LOANS TO GRADUATE STUDENTS

§ 292. Statement of purpose
The purpose of this subpart is to enable the
Secretary to provide a Federal program of student loan insurance for students in (and certain
former students of) eligible institutions (as defined in section 292o of this title).
(July 1, 1944, ch. 373, title VII, § 701, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1994.)
PRIOR PROVISIONS
A prior section 292, act July 1, 1944, ch. 373, title VII,
§ 700, as added Oct. 12, 1976, Pub. L. 94–484, title II,
§ 201(b), 90 Stat. 2246, set forth limitations on use of appropriations, prior to repeal by Pub. L. 97–35, title
XXVII, § 2715, Aug. 13, 1981, 95 Stat. 913.
Another prior section 292, act July 1, 1944, ch. 373,
title VII, § 701, as added July 30, 1956, ch. 779, § 2, 70 Stat.
717; amended Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164, stated Congressional findings and declaration of
policy respecting grants for construction of health research facilities, prior to repeal by Pub. L. 94–484, title
II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 701 of act July 1, 1944, was classified
to section 292a of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
EFFECTIVE DATE
Section 103 of Pub. L. 102–408 provided that: ‘‘The
amendment made by section 102 [enacting this subchapter] takes effect on the date of the enactment of
this Act [Oct. 13, 1992], except that section 708 of the
Public Health Service Act [section 292g of this title], as
added by section 102 of this Act, takes effect January
1, 1993. Until such date, section 732(c) of the Public
Health Service Act [former section 294e(c) of this title],
as in effect on the day before the date of the enactment

Page 752

of this Act, continues in effect in lieu of such section
708.’’
STUDY ON EFFECTIVENESS OF HEALTH PROFESSIONS
PROGRAMS
Pub. L. 102–408, title III, § 309, Oct. 13, 1992, 106 Stat.
2089, directed the Comptroller General to conduct a
study of the programs carried out under this subchapter and subchapter VI of this chapter for the purpose of determining the effectiveness of such programs
in increasing the number of primary care providers
(physicians, physician assistants, nurse midwives,
nurse practitioners and general dentists), nurses and
allied health personnel, improving the geographic distribution of health professionals in medically underserved and rural areas, and recruiting and retaining as
students in health professions schools individuals who
are members of a minority group, and report to the
Congress not later than Jan. 1, 1994, on findings and
recommendations made as a result of the study relevant to the reauthorization of such programs.

§ 292a. Scope and duration of loan insurance program
(a) In general
The total principal amount of new loans made
and installments paid pursuant to lines of credit
(as defined in section 292o of this title) to borrowers covered by Federal loan insurance under
this subpart shall not exceed $350,000,000 for fiscal year 1993, $375,000,000 for fiscal year 1994, and
$425,000,000 for fiscal year 1995. If the total
amount of new loans made and installments
paid pursuant to lines of credit in any fiscal
year is less than the ceiling established for such
year, the difference between the loans made and
installments paid and the ceiling shall be carried over to the next fiscal year and added to the
ceiling applicable to that fiscal year, and if in
any fiscal year no ceiling has been established,
any difference carried over shall constitute the
ceiling for making new loans (including loans to
new borrowers) and paying installments for such
fiscal year. Thereafter, Federal loan insurance
pursuant to this subpart may be granted only
for loans made (or for loan installments paid
pursuant to lines of credit) to enable students,
who have obtained prior loans insured under this
subpart, to continue or complete their educational program or to obtain a loan under section 292d(a)(1)(B) of this title to pay interest on
such prior loans; but no insurance may be granted for any loan made or installment paid after
September 30, 1998. The total principal amount
of Federal loan insurance available under this
subsection shall be granted by the Secretary
without regard to any apportionment for the
purpose of chapter 15 of title 31 and without regard to any similar limitation.
(b) Certain limitations and priorities
(1) Limitations regarding lenders, States, or
areas
The Secretary may, if necessary to assure an
equitable distribution of the benefits of this
subpart, assign, within the maximum amounts
specified in subsection (a) of this section, Federal loan insurance quotas applicable to eligible lenders, or to States or areas, and may
from time to time reassign unused portions of
these quotas.
(2) Priority for certain lenders
In providing certificates of insurance under
section 292e of this title through comprehen-

Page 753

TITLE 42—THE PUBLIC HEALTH AND WELFARE

sive contracts, the Secretary shall give priority to eligible lenders that agree—
(A) to make loans to students at interest
rates below the rates prevailing, during the
period involved, for loans covered by Federal
loan insurance pursuant to this subpart; or
(B) to make such loans under terms that
are otherwise favorable to the student relative to the terms under which eligible lenders are generally making such loans during
such period.
(c) Authority of Student Loan Marketing Association
(1) In general
Subject to paragraph (2), the Student Loan
Marketing Association, established under part
B of title IV of the Higher Education Act of
1965 [20 U.S.C. 1071 et seq.], is authorized to
make advances on the security of, purchase,
service, sell, consolidate, or otherwise deal in
loans which are insured by the Secretary
under this subpart, except that if any loan
made under this subpart is included in a consolidated loan pursuant to the authority of the
Association under part B of title IV of the
Higher Education Act of 1965, the interest rate
on such consolidated loan shall be set at the
weighted average interest rate of all such
loans offered for consolidation and the resultant per centum shall be rounded downward to
the nearest one-eighth of 1 per centum, except
that the interest rate shall be no less than the
applicable interest rate of the guaranteed student loan program established under part B of
title IV of the Higher Education Act of 1965. In
the case of such a consolidated loan, the borrower shall be responsible for any interest
which accrues prior to the beginning of the repayment period of the loan, or which accrues
during a period in which principal need not be
paid (whether or not such principal is in fact
paid) by reason of any provision of the Higher
Education Act of 1965 [20 U.S.C. 1001 et seq., 42
U.S.C. 2751 et seq.].
(2) Applicability of certain Federal regulations
With respect to Federal regulations for lenders, this subpart may not be construed to preclude the applicability of such regulations to
the Student Loan Marketing Association or to
any other entity in the business of purchasing
student loans, including such regulations with
respect to applications, contracts, and due
diligence.
(July 1, 1944, ch. 373, title VII, § 702, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1994.)
REFERENCES IN TEXT
The Higher Education Act of 1965, referred to in subsec. (c)(1), is Pub. L. 89–329, Nov. 8, 1965, 79 Stat. 1219,
which is classified generally to chapter 28 (§ 1001 et seq.)
of Title 20, Education, and part C (§ 2751 et seq.) of subchapter I of chapter 34 of this title. Part B of title IV
of the Act is classified generally to part B (§ 1071 et
seq.) of subchapter IV of chapter 28 of Title 20. For
complete classification of this Act to the Code, see
Short Title note set out under section 1001 of Title 20
and Tables.
PRIOR PROVISIONS
A prior section 292a, act July 1, 1944, ch. 373, title VII,
§ 701, formerly § 724, as added Sept. 24, 1963, Pub. L.

§ 292b

88–129, § 2(b), 77 Stat. 169; amended Oct. 22, 1965, Pub. L.
89–290, § 2(b), 79 Stat. 1056; Nov. 2, 1966, Pub. L. 89–709,
§ 2(c), 80 Stat. 1103; Aug. 16, 1968, Pub. L. 90–490, title I,
§ 105(c), 82 Stat. 774; Nov. 18, 1971, Pub. L. 92–157, title I,
§ 102(c)(1)–(4), (f)(2)(B), 85 Stat. 431, 432, 435; renumbered
§ 701 and amended Oct. 12, 1976, Pub. L. 94–484, title II,
§ 201(c), (e), 90 Stat. 2247; Aug. 13, 1981, Pub. L. 97–35,
title XXVII, § 2716, 95 Stat. 913; Oct. 22, 1985, Pub. L.
99–129, title II, §§ 201(a), (b), 202, 203, 204(a), (b), 99 Stat.
525–527; Nov. 4, 1988, Pub. L. 100–607, title VI, §§ 620(a),
623, 628(1), 629(b)(1), (2), 102 Stat. 3141, 3142, 3145, 3146;
Aug. 16, 1989, Pub. L. 101–93, § 5(l), 103 Stat. 613, defined
terms for purposes of this subchapter, prior to the general revision of this subchapter by Pub. L. 102–408. See
sections 292o and 295p of this title.
Another prior section 292a, act July 1, 1944, ch. 373,
title VII, § 702, as added July 30, 1956, ch. 779, § 2, 70 Stat.
717; amended Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164, defined ‘‘Council’’, ‘‘construction’’, ‘‘cost of construction’’, ‘‘nonprofit institution’’, and ‘‘sciences related to health’’ as applicable to grants for construction of health research facilities, prior to repeal by
Pub. L. 94–484, title II, § 201(a), Oct. 12, 1976, 90 Stat.
2246.
A prior section 702 of act July 1, 1944, was classified
to section 292b of this title prior to the general revision
of this subchapter by Pub. L. 102–408.

§ 292b. Limitations on individual insured loans
and on loan insurance
(a) In general
The total of the loans made to a student in
any academic year or its equivalent (as determined by the Secretary) which may be covered
by Federal loan insurance under this subpart
may not exceed $20,000 in the case of a student
enrolled in a school of medicine, osteopathic
medicine, dentistry, veterinary medicine, optometry, or podiatric medicine, and $12,500 in
the case of a student enrolled in a school of
pharmacy, public health, allied health, or chiropractic, or a graduate program in health administration or behavioral and mental health practice, including clinical psychology. The aggregate insured unpaid principal amount for all
such insured loans made to any borrower shall
not at any time exceed $80,000 in the case of a
borrower who is or was a student enrolled in a
school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, or podiatric medicine, and $50,000 in the case of a borrower who is or was a student enrolled in a
school of pharmacy, public health, allied health,
or chiropractic, or a graduate program in health
administration or clinical psychology. The annual insurable limit per student shall not be exceeded by a line of credit under which actual
payments by the lender to the borrower will not
be made in any year in excess of the annual
limit.
(b) Extent of insurance liability
The insurance liability on any loan insured by
the Secretary under this subpart shall be 100
percent of the unpaid balance of the principal
amount of the loan plus interest. The full faith
and credit of the United States is pledged to the
payment of all amounts which may be required
to be paid under the provisions of section 292f or
292m of this title.
(July 1, 1944, ch. 373, title VII, § 703, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1995; amended Pub. L. 105–392, title I,
§ 141(c)(1), Nov. 13, 1998, 112 Stat. 3579.)

§ 292c

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 292b, act July 1, 1944, ch. 373, title VII,
§ 702, formerly § 725, as added Sept. 24, 1963, Pub. L.
88–129, § 2(b), 77 Stat. 169; amended Sept. 4, 1964, Pub. L.
88–581, § 3(c), 78 Stat. 919; Nov. 2, 1966, Pub. L. 89–709,
§ 2(d), 80 Stat. 1103; Nov. 3, 1966, Pub. L. 89–751, § 3(a), 80
Stat. 1230; Dec. 5, 1967, Pub. L. 90–174, § 12(c), 81 Stat.
541; Oct. 30, 1970, Pub. L. 91–515, title VI, § 601(b)(2), 84
Stat. 1311; Nov. 18, 1971, Pub. L. 92–157, title I, § 108(a),
85 Stat. 460; renumbered § 702 and amended Oct. 12, 1976,
Pub. L. 94–484, title II, §§ 201(c), 202(a)(1), (2), (b), 90 Stat.
2247, 2248; Oct. 22, 1985, Pub. L. 99–129, title II, § 205(a),
99 Stat. 527; Nov. 4, 1988, Pub. L. 100–607, title VI,
§§ 620(b), 628(2), 102 Stat. 3141, 3145, related to National
Advisory Council on Education for Health Professions,
prior to the general revision of this subchapter by Pub.
L. 102–408.
Another prior section 292b, act July 1, 1944, ch. 373,
title VII, § 703, as added July 30, 1956, ch. 779, § 2, 70 Stat.
717; amended Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164; Aug. 16, 1968, Pub. L. 90–490, title IV, § 403, 82 Stat.
789; Oct. 30, 1970, Pub. L. 91–515, title VI, § 601(a)(1),
(b)(2), 84 Stat. 1310, 1311; Nov. 18, 1971, Pub. L. 92–157,
title I, § 102(k)(2)(A), 85 Stat. 437, related to National
Advisory Council on Health Research Facilities, providing for its establishment, composition, selection of
members; its functions; and use of its services in administration of grants for construction of health research facilities, prior to repeal by Pub. L. 94–484, title
II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 703 of act July 1, 1994, was classified
to section 292c of this title prior to repeal by Pub. L.
99–129.
AMENDMENTS
1998—Subsec. (a). Pub. L. 105–392 substituted ‘‘or behavioral and mental health practice, including clinical
psychology’’ for ‘‘or clinical psychology’’ in first sentence.

§ 292c. Sources of funds
Loans made by eligible lenders in accordance
with this subpart shall be insurable by the Secretary whether made from funds fully owned by
the lender or from funds held by the lender in a
trust or similar capacity and available for such
loans.
(July 1, 1944, ch. 373, title VII, § 704, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1996.)
PRIOR PROVISIONS
A prior section 292c, act July 1, 1944, ch. 373, title VII,
§ 703, formerly § 799, as added Nov. 2, 1970, Pub. L. 91–519,
title II, § 206, 84 Stat. 1354; amended Nov. 18, 1971, Pub.
L. 92–157, title I, § 109, 85 Stat. 461; renumbered § 703 and
amended Oct. 12, 1976, Pub. L. 94–484, title II, §§ 201(c),
203, 90 Stat. 2247, 2248; Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2717, 95 Stat. 914, related to advance funding
for grants and contracts, prior to repeal by Pub. L.
99–129, title II, § 220(a), Oct. 22, 1985, 99 Stat. 543.
Another prior section 292c, act July 1, 1944, ch. 373,
title VII, § 704, as added July 30, 1956, 779, § 2, 70 Stat.
718; amended Aug. 27, 1958, Pub. L. 85–777, § 1(a), 72 Stat.
933; Oct. 5, 1961, Pub. L. 87–395, § 8(a), (d), 75 Stat. 827;
Oct. 17, 1962, Pub. L. 87–838, § 4(a), 76 Stat. 1074; Aug. 9,
1965, Pub. L. 89–115, § 2(a), 79 Stat. 448; Aug. 16, 1968,
Pub. L. 90–490, title IV, § 401(a), 82 Stat. 789, related to
authorization of appropriations and availability of
funds for grants for construction of health research facilities, prior to repeal by Pub. L. 94–484, title II,
§ 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 704 of act July 1, 1944, was classified
to section 292d of this title prior to the general revision
of this subchapter by Pub. L. 102–408.

Page 754

§ 292d. Eligibility of borrowers and terms of insured loans
(a) In general
A loan by an eligible lender shall be insurable
by the Secretary under the provisions of this
subpart only if—
(1) made to—
(A) a student who—
(i)(I) has been accepted for enrollment at
an eligible institution, or (II) in the case of
a student attending an eligible institution,
is in good standing at that institution, as
determined by the institution;
(ii) is or will be a full-time student at
the eligible institution;
(iii) has agreed that all funds received
under such loan shall be used solely for
tuition, other reasonable educational expenses, including fees, books, and laboratory expenses, and reasonable living expenses, incurred by such students;
(iv) if required under section 453 of title
50, Appendix, to present himself for and
submit to registration under such section,
has presented himself and submitted to
registration under such section; and
(v) in the case of a pharmacy student,
has satisfactorily completed three years of
training; or
(B) an individual who—
(i) has previously had a loan insured
under this subpart when the individual was
a full-time student at an eligible institution;
(ii) is in a period during which, pursuant
to paragraph (2), the principal amount of
such previous loan need not be paid;
(iii) has agreed that all funds received
under the proposed loan shall be used solely for repayment of interest due on previous loans made under this subpart; and
(iv) if required under section 453 of title
50, Appendix, to present himself for and
submit to registration under such section,
has presented himself and submitted to
registration under such section;
(2) evidenced by a note or other written
agreement which—
(A) is made without security and without
endorsement, except that if the borrower is
a minor and such note or other written
agreement executed by him would not, under
the applicable law, create a binding obligation, an endorsement may be required;
(B) provides for repayment of the principal
amount of the loan in installments over a
period of not less than 10 years (unless sooner repaid) nor more than 25 years beginning
not earlier than 9 months nor later than 12
months after the date of—
(i) the date on which—
(I) the borrower ceases to be a participant in an accredited internship or residency program of not more than four
years in duration;
(II) the borrower completes the fourth
year of an accredited internship or residency program of more than four years
in duration; or

Page 755

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(III) the borrower, if not a participant
in a program described in subclause (I)
or (II), ceases to carry, at an eligible institution, the normal full-time academic
workload as determined by the institution; or
(ii) the date on which a borrower who is
a graduate of an eligible institution ceases
to be a participant in a fellowship training
program not in excess of two years or a
participant in a full-time educational activity not in excess of two years, which—
(I) is directly related to the health profession for which the borrower prepared
at an eligible institution, as determined
by the Secretary; and
(II) may be engaged in by the borrower
during such a two-year period which begins within twelve months after the
completion of the borrower’s participation in a program described in subclause
(I) or (II) of clause (i) or prior to the
completion of the borrower’s participation in such program,
except as provided in subparagraph (C), except that the period of the loan may not exceed 33 years from the date of execution of
the note or written agreement evidencing it,
and except that the note or other written instrument may contain such provisions relating to repayment in the event of default in
the payment of interest or in the payment of
the costs of insurance premiums, or other
default by the borrower, as may be authorized by regulations of the Secretary in effect
at the time the loan is made;
(C) provides that periodic installments of
principal and interest need not be paid, but
interest shall accrue, during any period (i)
during which the borrower is pursuing a fulltime course of study at an eligible institution (or at an institution defined by section
1002(a) of title 20); (ii) not in excess of four
years during which the borrower is a participant in an accredited internship or residency
program (including any period in such a program described in subclause (I) or subclause
(II) of subparagraph (B)(i)); (iii) not in excess
of three years, during which the borrower is
a member of the Armed Forces of the United
States; (iv) not in excess of three years during which the borrower is in service as a volunteer under the Peace Corps Act [22 U.S.C.
2501 et seq.]; (v) not in excess of three years
during which the borrower is a member of
the National Health Service Corps; (vi) not
in excess of three years during which the
borrower is in service as a full-time volunteer under title I of the Domestic Volunteer
Service Act of 1973 [42 U.S.C. 4951 et seq.];
(vii) not in excess of 3 years, for a borrower
who has completed an accredited internship
or residency training program in osteopathic
general practice, family medicine, general
internal medicine, preventive medicine, or
general pediatrics and who is practicing primary care; (viii) not in excess of 1 year, for
borrowers who are graduates of schools of
chiropractic; (ix) any period not in excess of
two years which is described in subpara-

§ 292d

graph (B)(ii); (x) not in excess of three years,
during which the borrower is providing
health care services to Indians through an
Indian health program (as defined in section
1616a(a)(2)(A) of title 25; 1 and (xi) in addition
to all other deferments for which the borrower is eligible under clauses (i) through
(x), any period during which the borrower is
a member of the Armed Forces on active
duty during the Persian Gulf conflict, and
any period described in clauses (i) through
(xi) shall not be included in determining the
25-year period described in subparagraph (B);
(D) provides for interest on the unpaid
principal balance of the loan at a yearly
rate, not exceeding the applicable maximum
rate prescribed and defined by the Secretary
(within the limits set forth in subsection (b)
of this section) on a national, regional, or
other appropriate basis, which interest shall
be compounded not more frequently than annually and payable in installments over the
period of the loan except as provided in subparagraph (C), except that the note or other
written agreement may provide that payment of any interest may be deferred until
not later than the date upon which repayment of the first installment of principal
falls due or the date repayment of principal
is required to resume (whichever is applicable) and may further provide that, on such
date, the amount of the interest which has
so accrued may be added to the principal for
the purposes of calculating a repayment
schedule;
(E) offers, in accordance with criteria prescribed by regulation by the Secretary, a
schedule for repayment of principal and interest under which payment of a portion of
the principal and interest otherwise payable
at the beginning of the repayment period (as
defined in such regulations) is deferred until
a later time in the period;
(F) entitles the borrower to accelerate
without penalty repayment of the whole or
any part of the loan;
(G) provides that the check for the proceeds of the loan shall be made payable
jointly to the borrower and the eligible institution in which the borrower is enrolled;
and
(H) contains such other terms and conditions consistent with the provisions of this
subpart and with the regulations issued by
the Secretary pursuant to this subpart, as
may be agreed upon by the parties to such
loan, including, if agreed upon, a provision
requiring the borrower to pay to the lender,
in addition to principal and interest,
amounts equal to the insurance premiums
payable by the lender to the Secretary with
respect to such loan; and
(3) subject to the consent of the student and
subject to applicable law, the eligible lender
has obtained from the student appropriate demographic information regarding the student,
including racial or ethnic background.
1 So in original. Probably should be preceded by a closing
parenthesis.

§ 292e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Limitation on rate of interest
The rate of interest prescribed and defined by
the Secretary for the purpose of subsection
(a)(2)(D) of this section may not exceed the average of the bond equivalent rates of the 91-day
Treasury bills auctioned for the previous quarter plus 3 percentage points, rounded to the next
higher one-eighth of 1 percent.
(c) Minimum annual payment by borrower
The total of the payments by a borrower during any year or any repayment period with respect to the aggregate amount of all loans to
that borrower which are insured under this subpart shall not be less than the annual interest
on the outstanding principal, except as provided
in subsection (a)(2)(C) of this section, unless the
borrower, in the written agreement described in
subsection (a)(2) of this section, agrees to make
payments during any year or any repayment period in a lesser amount.
(d) Applicability of certain laws on rate or
amount of interest
No provision of any law of the United States
(other than subsections (a)(2)(D) and (b) of this
section) or of any State that limits the rate or
amount of interest payable on loans shall apply
to a loan insured under this subpart.
(e) Determination regarding forbearance
Any period of time granted to a borrower
under this subpart in the form of forbearance on
the loan shall not be included in the 25-year
total loan repayment period under subsection
(a)(2)(C) of this section.
(f) Loan repayment schedule
Lenders and holders under this subpart shall
offer borrowers graduated loan repayment
schedules that, during the first 5 years of loan
repayment, are based on the borrower’s debt-toincome ratio.
(g) Rule of construction regarding determination
of need of students
With respect to any determination of the financial need of a student for a loan covered by
Federal loan insurance under this subpart, this
subpart may not be construed to limit the authority of any school to make such allowances
for students with special circumstances as the
school determines appropriate.
(h) Definitions
For purposes of this section:
(1) The term ‘‘active duty’’ has the meaning
given such term in section 101(18) of title 37,
except that such term does not include active
duty for training.
(2) The term ‘‘Persian Gulf conflict’’ means
the period beginning on August 2, 1990, and
ending on the date thereafter prescribed by
Presidential proclamation or by law.
(July 1, 1944, ch. 373, title VII, § 705, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 1996; amended Pub. L. 103–43, title XX,
§ 2014(a)(1), June 10, 1993, 107 Stat. 215; Pub. L.
105–244, title I, § 102(a)(13)(A), Oct. 7, 1998, 112
Stat. 1620; Pub. L. 105–392, title I, § 141(a)(1), (2),
Nov. 13, 1998, 112 Stat. 3578.)
REFERENCES IN TEXT
The Peace Corps Act, referred to in subsec. (a)(2)(C),
is Pub. L. 87–293, Sept. 22, 1961, 75 Stat. 612, as amended,

Page 756

which is classified principally to chapter 34 (§ 2501 et
seq.) of Title 22, Foreign Relations and Intercourse. For
complete classification of this Act to the Code, see
Short Title note set out under section 2501 of Title 22
and Tables.
The Domestic Volunteer Service Act of 1973, referred
to in subsec. (a)(2)(C), is Pub. L. 93–113, Oct. 1, 1973, 87
Stat. 394, as amended. Title I of the Act is classified
generally to subchapter I (§ 4951 et seq.) of chapter 66 of
this title. For complete classification of this Act to the
Code, see Short Title note set out under section 4950 of
this title and Tables.
PRIOR PROVISIONS
A prior section 292d, act July 1, 1944, ch. 373, title VII,
§ 704, formerly § 799A, as added Nov. 2, 1970, Pub. L.
91–519, title II, § 207, 84 Stat. 1355; amended Nov. 18, 1971,
Pub. L. 92–157, title I, § 110(2), 85 Stat. 461; July 12, 1974,
Pub. L. 93–348, title I, § 105, 88 Stat. 347; renumbered
§ 704, Oct. 12, 1976, Pub. L. 94–484, title II, § 201(c), 90
Stat. 2247; Nov. 4, 1988, Pub. L. 100–607, title VI, §§ 620(c),
628(3), 629(b)(2), 102 Stat. 3141, 3145, 3146, prohibited discrimination on the basis of sex, prior to the general revision of this subchapter by Pub. L. 102–408. See section
295m of this title.
Another prior section 292d, act July 1, 1944, ch. 373,
title VII, § 705, as added July 30, 1956, ch. 779, § 2, 70 Stat.
718; amended Aug. 27, 1958, Pub. L. 85–777, § 1(b), 72 Stat.
933; Oct. 5, 1961, Pub. L. 87–395, § 8(b), (d), 75 Stat. 827;
Oct. 17, 1962, Pub. L. 87–838, § 4(b), 76 Stat. 1074; Sept. 24,
1963, Pub. L. 88–129, §§ 2(a), 3(a), 77 Stat. 164, 173; Aug. 9,
1965, Pub. L. 89–115, § 2(b), 79 Stat. 448; Aug. 16, 1968,
Pub. L. 90–490, title IV, § 401(b), 82 Stat. 789; Nov. 18,
1971, Pub. L. 92–157, title I, § 102(k)(1), (2)(A), 85 Stat.
437, related to applications for grants for construction
of health research facilities, providing for time of filing, eligibility, recommendation and approval and requirement of findings, conditional approval, and matters considered, prior to repeal by Pub. L. 94–484, title
II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 705 of act July 1, 1944, was classified
to section 292e of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (a)(2)(C). Pub. L. 105–392 added cl. (x),
redesignated former cl. (x) as (xi) and substituted ‘‘(x)’’
for ‘‘(ix)’’, and substituted ‘‘(xi)’’ for ‘‘(x)’’ in concluding provisions.
Pub. L. 105–244 substituted ‘‘section 1002(a)’’ for ‘‘section 1088(a)’’ in cl. (i).
1993—Subsec. (a)(2)(H), (I). Pub. L. 103–43 redesignated
subpar. (I) as (H) and struck out former subpar. (H)
which read as follows: ‘‘notwithstanding the provisions
of the Fair Debt Collection Practices Act, authorizes
an institution or postgraduate training program attended by the borrower to assist in the collection of
any loan that becomes delinquent, including providing
information concerning the borrower to the Secretary
and to past and present lenders and holders of the borrower’s loans; and’’.
EFFECTIVE DATE OF 1998 AMENDMENTS
Pub. L. 105–392, title I, § 141(a)(3), Nov. 13, 1998, 112
Stat. 3578, provided that: ‘‘The amendments made by
this subsection [amending this section] shall apply
with respect to services provided on or after the first
day of the third month that begins after the date of the
enactment of this Act [Nov. 13, 1998].’’
Amendment by Pub. L. 105–244 effective Oct. 1, 1998,
except as otherwise provided in Pub. L. 105–244, see section 3 of Pub. L. 105–244, set out as a note under section
1001 of Title 20, Education.

§ 292e. Certificate of loan insurance; effective
date of insurance
(a) In general
(1) Authority for issuance of certificate
If, upon application by an eligible lender,
made upon such form, containing such infor-

Page 757

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mation, and supported by such evidence as the
Secretary may require, and otherwise in conformity with this section, the Secretary finds
that the applicant has made a loan to an eligible borrower which is insurable under the provisions of this subpart, he may issue to the applicant a certificate of insurance covering the
loan and setting forth the amount and terms
of the insurance.
(2) Effective date of insurance
Insurance evidenced by a certificate of insurance pursuant to subsection (a)(1) of this
section shall become effective upon the date of
issuance of the certificate, except that the
Secretary is authorized, in accordance with
regulations, to issue commitments with respect to proposed loans, or with respect to
lines (or proposed lines) of credit, submitted
by eligible lenders, and in that event, upon
compliance with subsection (a)(1) of this section by the lender, the certificate of insurance
may be issued effective as of the date when
any loan, or any payment by the lender pursuant to a line of credit, to be covered by such
insurance is made to a student described in
section 292d(a)(1) of this title. Such insurance
shall cease to be effective upon 60 days’ default by the lender in the payment of any installment of the premiums payable pursuant
to section 292g of this title.
(3) Certain agreements for lenders
An application submitted pursuant to subsection (a)(1) of this section shall contain—
(A) an agreement by the applicant to pay,
in accordance with regulations, the premiums fixed by the Secretary pursuant to
section 292g of this title; and
(B) an agreement by the applicant that if
the loan is covered by insurance the applicant will submit such supplementary reports
and statements during the effective period of
the loan agreement, upon such forms, at
such times, and containing such information
as the Secretary may prescribe by or pursuant to regulation.
(b) Authority regarding comprehensive insurance coverage
(1) In general
In lieu of requiring a separate insurance application and issuing a separate certificate of
insurance for each loan made by an eligible
lender as provided in subsection (a) of this section, the Secretary may, in accordance with
regulations consistent with section 292a of this
title, issue to any eligible lender applying
therefor a certificate of comprehensive insurance coverage which shall, without further action by the Secretary, insure all insurable
loans made by that lender, on or after the date
of the certificate and before a specified cutoff
date, within the limits of an aggregate maximum amount stated in the certificate. Such
regulations may provide for conditioning such
insurance, with respect to any loan, upon compliance by the lender with such requirements
(to be stated or incorporated by reference in
the certificate) as in the Secretary’s judgment
will best achieve the purpose of this subsection while protecting the financial interest

§ 292e

of the United States and promoting the objectives of this subpart, including (but not limited to) provisions as to the reporting of such
loans and information relevant thereto to the
Secretary and as to the payment of initial and
other premiums and the effect of default
therein, and including provision for confirmation by the Secretary from time to time
(through endorsement of the certificate) of the
coverage of specific new loans by such certificate, which confirmation shall be incontestable by the Secretary in the absence of fraud
or misrepresentation of fact or patent error.
(2) Lines of credit beyond cutoff date
If the holder of a certificate of comprehensive insurance coverage issued under this subsection grants to a borrower a line of credit
extending beyond the cutoff date specified in
that certificate, loans or payments thereon
made by the holder after that date pursuant to
the line of credit shall not be deemed to be included in the coverage of that certificate except as may be specifically provided therein;
but, subject to the limitations of section 292a
of this title, the Secretary may, in accordance
with regulations, make commitments to insure such future loans or payments, and such
commitments may be honored either as provided in subsection (a) of this section or by inclusion of such insurance in comprehensive
coverage under this subsection for the period
or periods in which such future loans or payments are made.
(c) Assignment of insurance rights
The rights of an eligible lender arising under
insurance evidenced by a certificate of insurance
issued to it under this section may be assigned
by such lender, subject to regulation by the Secretary, only to—
(1) another eligible lender (including a public entity in the business of purchasing student loans); or
(2) the Student Loan Marketing Association.
(d) Effect of refinancing or consolidation of obligations
The consolidation of the obligations of two or
more federally insured loans obtained by a borrower in any fiscal year into a single obligation
evidenced by a single instrument of indebtedness or the refinancing of a single loan shall not
affect the insurance by the United States. If the
loans thus consolidated are covered by separate
certificates of insurance issued under subsection
(a) of this section, the Secretary may upon surrender of the original certificates issue a new
certificate of insurance in accordance with that
subsection upon the consolidated obligation. If
the loans thus consolidated are covered by a single comprehensive certificate issued under subsection (b) of this section, the Secretary may
amend that certificate accordingly.
(e) Rule of construction regarding consolidation
of debts and refinancing
Nothing in this section shall be construed to
preclude the lender and the borrower, by mutual
agreement, from consolidating all of the borrower’s loans insured under this subpart into a single instrument (or, if the borrower obtained

§ 292f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

only 1 loan insured under this subpart, refinancing the loan 1 time) under the terms applicable
to an insured loan made at the same time as the
consolidation. The lender or loan holder should
provide full information to the borrower concerning the advantages and disadvantages of
loan consolidation or refinancing. Nothing in
this section shall be construed to preclude the
consolidation of the borrower’s loans insured
under this subpart under section 1078–3 of title
20. Any loans insured pursuant to this subpart
that are consolidated under section 1078–3 of
title 20 shall not be eligible for special allowance payments under section 1087–1 of title 20.
(July 1, 1944, ch. 373, title VII, § 706, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2000; amended Pub. L. 105–392, title I, § 145,
Nov. 13, 1998, 112 Stat. 3581.)
PRIOR PROVISIONS
A prior section 292e, act July 1, 1944, ch. 373, title VII,
§ 705, as added Oct. 12, 1976, Pub. L. 94–484, title II, § 204,
90 Stat. 2248; amended Nov. 9, 1978, Pub. L. 95–623, § 11(f),
92 Stat. 3456; Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2718, 95 Stat. 914, related to establishment and maintenance of records and annual financial reports and audits, prior to the general revision of this subchapter by
Pub. L. 102–408.
Another prior section 292e, act July 1, 1944, ch. 373,
title VII, § 706, as added July 30, 1956, 779, § 2, 70 Stat.
719; amended Oct. 5, 1961, Pub. L. 87–395, § 8(c), (d), 75
Stat. 827; Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164; Aug. 16, 1968, Pub. L. 90–490, title IV, § 402, 82 Stat.
789; Nov. 18, 1971, Pub. L. 92–157, title I, § 102(k)(2)(A),
(B), 85 Stat. 437, limited amount of grant available for
construction of health research facilities, including
provisions relating to its maximum, reservation of
amount, manner of payment, and exclusion of amounts
granted by certain other funds, prior to repeal by Pub.
L. 94–484, title II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 706 of act July 1, 1944, was classified
to section 292f of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
Another prior section 706 of act July 1, 1944, was classified to section 230 of this title prior to repeal by act
Apr. 27, 1956, ch. 211, § 5(e), 70 Stat. 117.
AMENDMENTS
1998—Subsec. (d). Pub. L. 105–392, § 145(1), in heading,
substituted ‘‘refinancing or consolidation’’ for ‘‘consolidation’’ and, in first sentence, substituted ‘‘indebtedness or the refinancing of a single loan’’ for ‘‘indebtedness’’.
Subsec. (e). Pub. L. 105–392, § 145(2), in heading, substituted ‘‘debts and refinancing’’ for ‘‘debts’’, in first
sentence, substituted ‘‘all of the borrower’s loans insured under this subpart into a single instrument (or,
if the borrower obtained only 1 loan insured under this
subpart, refinancing the loan 1 time)’’ for ‘‘all of the
borrower’s debts into a single instrument’’, and in second sentence, substituted ‘‘consolidation or refinancing’’ for ‘‘consolidation’’.

§ 292f. Default of borrower
(a) Conditions for payment to beneficiary
(1) In general
Upon default by the borrower on any loan
covered by Federal loan insurance pursuant to
this subpart, and after a substantial collection
effort (including, subject to subsection (h) of
this section, commencement and prosecution
of an action) as determined under regulations
of the Secretary, the insurance beneficiary
shall promptly notify the Secretary and the

Page 758

Secretary shall, if requested (at that time or
after further collection efforts) by the beneficiary, or may on his own motion, if the insurance is still in effect, pay to the beneficiary
the amount of the loss sustained by the insured upon that loan as soon as that amount
has been determined, except that, if the insurance beneficiary including any servicer of the
loan is not designated for ‘‘exceptional performance’’, as set forth in paragraph (2), the
Secretary shall pay to the beneficiary a sum
equal to 98 percent of the amount of the loss
sustained by the insured upon that loan.
(2) Exceptional performance
(A) Authority
Where the Secretary determines that an
eligible lender, holder, or servicer has a compliance performance rating that equals or
exceeds 97 percent, the Secretary shall designate that eligible lender, holder, or servicer, as the case may be, for exceptional performance.
(B) Compliance performance rating
For purposes of subparagraph (A), a compliance performance rating is determined
with respect to compliance with due diligence in the disbursement, servicing, and
collection of loans under this subpart for
each year for which the determination is
made. Such rating shall be equal to the percentage of all due diligence requirements applicable to each loan, on average, as established by the Secretary, with respect to
loans serviced during the period by the eligible lender, holder, or servicer.
(C) Annual audits for lenders, holders, and
servicers
Each eligible lender, holder, or servicer desiring a designation under subparagraph (A)
shall have an annual financial and compliance audit conducted with respect to the
loan portfolio of such eligible lender, holder,
or servicer, by a qualified independent organization from a list of qualified organizations identified by the Secretary and in accordance with standards established by the
Secretary. The standards shall measure the
lender’s, holder’s, or servicer’s compliance
with due diligence standards and shall include a defined statistical sampling technique designed to measure the performance
rating of the eligible lender, holder, or servicer for the purpose of this section. Each eligible lender, holder, or servicer shall submit
the audit required by this section to the Secretary.
(D) Secretary’s determinations
The Secretary shall make the determination under subparagraph (A) based upon the
audits submitted under this paragraph and
any information in the possession of the
Secretary or submitted by any other agency
or office of the Federal Government.
(E) Quarterly compliance audit
To maintain its status as an exceptional
performer, the lender, holder, or servicer
shall undergo a quarterly compliance audit

Page 759

TITLE 42—THE PUBLIC HEALTH AND WELFARE

at the end of each quarter (other than the
quarter in which status as an exceptional
performer is established through a financial
and compliance audit, as described in subparagraph (C)), and submit the results of
such audit to the Secretary. The compliance
audit shall review compliance with due diligence requirements for the period beginning
on the day after the ending date of the previous audit, in accordance with standards
determined by the Secretary.
(F) Revocation authority
The Secretary shall revoke the designation of a lender, holder, or servicer under
subparagraph (A) if any quarterly audit required under subparagraph (E) is not received by the Secretary by the date established by the Secretary or if the audit indicates the lender, holder, or servicer has
failed to meet the standards for designation
as an exceptional performer under subparagraph (A). A lender, holder, or servicer receiving a compliance audit not meeting the
standard for designation as an exceptional
performer may reapply for designation under
subparagraph (A) at any time.
(G) Documentation
Nothing in this section shall restrict or
limit the authority of the Secretary to require the submission of claims documentation evidencing servicing performed on
loans, except that the Secretary may not require exceptional performers to submit
greater documentation than that required
for lenders, holders, and servicers not designated under subparagraph (A).
(H) Cost of audits
Each eligible lender, holder, or servicer
shall pay for all the costs associated with
the audits required under this section.
(I) Additional revocation authority
Notwithstanding any other provision of
this section, a designation under subparagraph (A) may be revoked at any time by the
Secretary if the Secretary determines that
the eligible lender, holder, or servicer has
failed to maintain an overall level of compliance consistent with the audit submitted by
the eligible lender, holder, or servicer under
this paragraph or if the Secretary asserts
that the lender, holder, or servicer may have
engaged in fraud in securing designation
under subparagraph (A) or is failing to service loans in accordance with program requirements.
(J) Noncompliance
A lender, holder, or servicer designated
under subparagraph (A) that fails to service
loans or otherwise comply with applicable
program regulations shall be considered in
violation of the Federal False Claims Act.
(b) Subrogation
Upon payment by the Secretary of the amount
of the loss pursuant to subsection (a) of this section, the United States shall be subrogated for
all of the rights of the holder of the obligation
upon the insured loan and shall be entitled to an

§ 292f

assignment of the note or other evidence of the
insured loan by the insurance beneficiary. If the
net recovery made by the Secretary on a loan
after deduction of the cost of that recovery (including reasonable administrative costs) exceeds
the amount of the loss, the excess shall be paid
over to the insured. The Secretary may sell
without recourse to eligible lenders (or other entities that the Secretary determines are capable
of dealing in such loans) notes or other evidence
of loans received through assignment under the
first sentence.
(c) Forbearance
Nothing in this section or in this subpart shall
be construed to preclude any forbearance for the
benefit of the borrower which may be agreed
upon by the parties to the insured loan and approved by the Secretary or to preclude forbearance by the Secretary in the enforcement of the
insured obligation after payment on that insurance.
(d) Reasonable care and diligence regarding
loans
Nothing in this section or in this subpart shall
be construed to excuse the eligible lender or
holder of a federally insured loan from exercising reasonable care and diligence in the making
of loans under the provisions of this subpart and
from exercising a substantial effort in the collection of loans under the provisions of this subpart. If the Secretary, after reasonable notice
and opportunity for hearing to an eligible lender, finds that the lender has failed to exercise
such care and diligence, to exercise such substantial efforts, to make the reports and statements required under section 292e(a)(3) of this
title, or to pay the required Federal loan insurance premiums, he shall disqualify that lender
from obtaining further Federal insurance on
loans granted pursuant to this subpart until he
is satisfied that its failure has ceased and finds
that there is reasonable assurance that the lender will in the future exercise necessary care and
diligence, exercise substantial effort, or comply
with such requirements, as the case may be.
(e) Definitions
For purposes of this section:
(1) The term ‘‘insurance beneficiary’’ means
the insured or its authorized assignee in accordance with section 292e(c) of this title.
(2) The term ‘‘amount of the loss’’ means,
with respect to a loan, unpaid balance of the
principal amount and interest on such loan,
less the amount of any judgment collected
pursuant to default proceedings commenced
by the eligible lender or holder involved.
(3) The term ‘‘default’’ includes only such
defaults as have existed for 120 days.
(4) The term ‘‘servicer’’ means any agency
acting on behalf of the insurance beneficiary.
(f) Reductions in Federal reimbursements or
payments for defaulting borrowers
The Secretary shall, after notice and opportunity for a hearing, cause to be reduced Federal
reimbursements or payments for health services
under any Federal law to borrowers who are
practicing their professions and have defaulted
on their loans insured under this subpart in

§ 292f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amounts up to the remaining balance of such
loans. Procedures for reduction of payments
under the medicare program are provided under
section 1395ccc of this title. Notwithstanding
such section 1395ccc of this title, any funds recovered under this subsection shall be deposited
in the insurance fund established under section
292i of this title.
(g) Conditions for discharge of debt in bankruptcy
Notwithstanding any other provision of Federal or State law, a debt that is a loan insured
under the authority of this subpart may be released by a discharge in bankruptcy under any
chapter of title 11, only if such discharge is
granted—
(1) after the expiration of the seven-year period beginning on the first date when repayment of such loan is required, exclusive of any
period after such date in which the obligation
to pay installments on the loan is suspended;
(2) upon a finding by the Bankruptcy Court
that the nondischarge of such debt would be
unconscionable; and
(3) upon the condition that the Secretary
shall not have waived the Secretary’s rights to
apply subsection (f) of this section to the borrower and the discharged debt.
(h) Requirement regarding actions for default
(1) In general
With respect to the default by a borrower on
any loan covered by Federal loan insurance
under this subpart, the Secretary shall, under
subsection (a) of this section, require an eligible lender or holder to commence and prosecute an action for such default unless—
(A) in the determination of the Secretary—
(i) the eligible lender or holder has made
reasonable efforts to serve process on the
borrower involved and has been unsuccessful with respect to such efforts, or
(ii) prosecution of such an action would
be fruitless because of the financial or
other circumstances of the borrower;
(B) for such loans made before November 4,
1988, the loan involved was made in an
amount of less than $5,000; or
(C) for such loans made after November 4,
1988, the loan involved was made in an
amount of less than $2,500.
(2) Relationship to claim for payment
With respect to an eligible lender or holder
that has commenced an action pursuant to
subsection (a) of this section, the Secretary
shall make the payment required in such subsection, or deny the claim for such payment,
not later than 60 days after the date on which
the Secretary determines that the lender or
holder has made reasonable efforts to secure a
judgment and collect on the judgment entered
into pursuant to this subsection.
(3) State court judgments
With respect to any State court judgment
that is obtained by a lender or holder against
a borrower for default on a loan insured under
this subpart and that is subrogated to the
United States under subsection (b) of this sec-

Page 760

tion, any United States attorney may register
such judgment with the Federal courts for enforcement.
(i) Inapplicability of Federal and State statute of
limitations on actions for loan collection
Notwithstanding any other provision of Federal or State law, there shall be no limitation on
the period within which suit may be filed, a
judgment may be enforced, or an offset, garnishment, or other action may be initiated or taken
by the Secretary, the Attorney General, or other
administrative head of another Federal agency,
as the case may be, for the repayment of the
amount due from a borrower on a loan made
under this subpart that has been assigned to the
Secretary under subsection (b) of this section.
(j) School collection assistance
An institution or postgraduate training program attended by a borrower may assist in the
collection of any loan of that borrower made
under this subpart which becomes delinquent,
including providing information concerning the
borrower to the Secretary and to past and
present lenders and holders of the borrower’s
loans, contacting the borrower in order to encourage repayment, and withholding services in
accordance with regulations issued by the Secretary under section 292n(a)(7) of this title. The
institution or postgraduate training program
shall not be subject to section 1692g of title 15
for purposes of carrying out activities authorized by this section.
(July 1, 1944, ch. 373, title VII, § 707, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2002; amended Pub. L. 103–43, title XX,
§ 2014(a)(2), June 10, 1993, 107 Stat. 215; Pub. L.
105–392, title I, §§ 142(a), (b), 144(a), Nov. 13, 1998,
112 Stat. 3579, 3581.)
REFERENCES IN TEXT
The Federal False Claims Act, referred to in subsec.
(a)(2)(J), probably means the False Claims Act which
was the popular name for sections 231, 232, 233, and 235
of former Title 31, Money and Finance. Sections 231,
232, 233, and 235 were repealed by Pub. L. 97–258, § 5(b),
Sept. 13, 1982, 96 Stat. 1084, and reenacted by the first
section thereof as sections 3729 to 3731 of Title 31,
Money and Finance.
PRIOR PROVISIONS
A prior section 292f, act July 1, 1944, ch. 373, title VII,
§ 706, as added Oct. 12, 1976, Pub. L. 94–484, title II, § 204,
90 Stat. 2249, authorized contracts under this subchapter without regard to certain provisions, prior to
the general revision of this subchapter by Pub. L.
102–408.
Another prior section 292f, act July 1, 1944, ch. 373,
title VII, § 707, as added July 30, 1956, ch. 779, § 2, 70 Stat.
720; amended Oct. 5, 1961, Pub. L. 87–395, § 8(d), 75 Stat.
827; Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat. 164; Nov.
18, 1971, Pub. L. 92–157, title I, § 102(k)(2)(A), 85 Stat. 437,
provided for recapture of payments relating to grants
for construction of health research facilities, prior to
repeal by Pub. L. 94–484, title II, § 201(a), Oct. 12, 1976,
90 Stat. 2246.
A prior section 707 of act July 1, 1944, was classified
to section 292g of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (a). Pub. L. 105–392, § 142(a), designated
existing provisions as par. (1), inserted heading, sub-

Page 761

TITLE 42—THE PUBLIC HEALTH AND WELFARE

stituted ‘‘determined, except that, if the insurance beneficiary including any servicer of the loan is not designated for ‘exceptional performance’, as set forth in
paragraph (2), the Secretary shall pay to the beneficiary a sum equal to 98 percent of the amount of the
loss sustained by the insured upon that loan.’’ for ‘‘determined.’’, struck out at end ‘‘Not later than one year
after October 13, 1992, the Secretary shall establish performance standards for lenders and holders of loans
under this subpart, including fees to be imposed for
failing to meet such standards.’’, and added par. (2).
Subsec. (e)(4). Pub. L. 105–392, § 142(b), added par. (4).
Subsec. (g). Pub. L. 105–392, § 144(a), substituted ‘‘Notwithstanding any other provision of Federal or State
law, a debt that is a loan insured’’ for ‘‘A debt which
is a loan insured’’ in introductory provisions.
1993—Subsec. (g)(1). Pub. L. 103–43, § 2014(a)(2)(A),
amended par. (1) generally. Prior to amendment, par.
(1) read as follows: ‘‘after the expiration of the fiveyear period beginning on the first date, as specified in
subparagraphs (B) and (C) of section 292d(a)(2) of this
title, when repayment of such loan is required;’’.
Subsec. (j). Pub. L. 103–43, § 2014(a)(2)(B), added subsec. (j).
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–392, title I, § 142(c), Nov. 13, 1998, 112 Stat.
3581, provided that: ‘‘The amendments made by subsections (a) and (b) [amending this section] shall apply
with respect to loans submitted to the Secretary for
payment on or after the first day of the sixth month
that begins after the date of enactment of this Act
[Nov. 13, 1998].’’
Pub. L. 105–392, title I, § 144(b), Nov. 13, 1998, 112 Stat.
3581, provided that: ‘‘The amendment made by subsection (a) [amending this section] shall apply to any
loan insured under the authority of subpart I of part A
of title VII of the Public Health Service Act (42 U.S.C.
292 et seq.) that is listed or scheduled by the debtor in
a case under title XI, United States Code [Title 11,
Bankruptcy], filed—
‘‘(1) on or after the date of enactment of this Act
[Nov. 13, 1998]; or
‘‘(2) prior to such date of enactment in which a discharge has not been granted.’’

§ 292g. Risk-based premiums
(a) Authority
With respect to a loan made under this subpart on or after January 1, 1993, the Secretary,
in accordance with subsection (b) of this section,
shall assess a risk-based premium on an eligible
borrower and, if required under this section, an
eligible institution that is based on the default
rate of the eligible institution involved (as defined in section 292o of this title).
(b) Assessment of premium
Except as provided in subsection (d)(2) of this
section, the risk-based premium to be assessed
under subsection (a) of this section shall be as
follows:
(1) Low-risk rate
With respect to an eligible borrower seeking
to obtain a loan for attendance at an eligible
institution that has a default rate of not to exceed five percent, such borrower shall be assessed a risk-based premium in an amount
equal to 6 percent of the principal amount of
the loan.
(2) Medium-risk rate
(A) In general
With respect to an eligible borrower seeking to obtain a loan for attendance at an eli-

§ 292g

gible institution that has a default rate of in
excess of five percent but not to exceed 10
percent—
(i) such borrower shall be assessed a riskbased premium in an amount equal to 8
percent of the principal amount of the
loan; and
(ii) such institution shall be assessed a
risk-based premium in an amount equal to
5 percent of the principal amount of the
loan.
(B) Default management plan
An institution of the type described in subparagraph (A) shall prepare and submit to
the Secretary for approval, an annual default management plan, that shall specify
the detailed short-term and long-term procedures that such institution will have in
place to minimize defaults on loans to borrowers under this subpart. Under such plan
the institution shall, among other measures,
provide an exit interview to all borrowers
that includes information concerning repayment schedules, loan deferments, forbearance, and the consequences of default.
(3) High-risk rate
(A) In general
With respect to an eligible borrower seeking to obtain a loan for attendance at an eligible institution that has a default rate of in
excess of 10 percent but not to exceed 20 percent—
(i) such borrower shall be assessed a riskbased premium in an amount equal to 8
percent of the principal amount of the
loan; and
(ii) such institution shall be assessed a
risk-based premium in an amount equal to
10 percent of the principal amount of the
loan.
(B) Default management plan
An institution of the type described in subparagraph (A) shall prepare and submit to
the Secretary for approval a plan that meets
the requirements of paragraph (2)(B).
(4) Ineligibility
An individual shall not be eligible to obtain
a loan under this subpart for attendance at an
institution that has a default rate in excess of
20 percent.
(c) Reduction of risk-based premium
Lenders shall reduce by 50 percent the riskbased premium to eligible borrowers if a credit
worthy parent or other responsible party cosigns the loan note.
(d) Administrative waivers
(1) Hearing
The Secretary shall afford an institution not
less than one hearing, and may consider mitigating circumstances, prior to making such
institution ineligible for participation in the
program under this subpart.
(2) Exceptions
In carrying out this section with respect to
an institution, the Secretary may grant an institution a waiver of requirements of para-

§ 292h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

graphs (2) through (4) of subsection (b) of this
section if the Secretary determines that the
default rate for such institution is not an accurate indicator because the volume of the
loans under this subpart made by such institution has been insufficient.
(3) Transition for certain institutions
During the 3-year period beginning on October 13, 1992—
(A) subsection (b)(4) of this section shall
not apply with respect to any eligible institution that is a Historically Black College
or University; and
(B) any such institution that has a default
rate in excess of 20 percent, and any eligible
borrower seeking a loan for attendance at
the institution, shall be subject to subsection (b)(3) of this section to the same extent and in the same manner as eligible institutions and borrowers described in such
subsection.
(e) Payoff to reduce risk category
An institution may pay off the outstanding
principal and interest owed by the borrowers of
such institution who have defaulted on loans
made under this subpart in order to reduce the
risk category of the institution.
(July 1, 1944, ch. 373, title VII, § 708, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2004.)
PRIOR PROVISIONS
A prior section 292g, act July 1, 1944, ch. 373, title VII,
§ 707, as added Oct. 12, 1976, Pub. L. 94–484, title II, § 205,
90 Stat. 2249; amended Aug. 1, 1977, Pub. L. 95–83, title
III, § 307(r), 91 Stat. 395, related to delegation of authority by the Secretary, prior to the general revision of
this subchapter by Pub. L. 102–408.
Another prior section 292g, act July 1, 1944, ch. 373,
title VII, § 708, as added July 30, 1956, ch. 779, § 2, 70 Stat.
720; amended Oct. 5, 1961, Pub. L. 87–395, § 8(d), 75 Stat.
827; Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat. 164, prohibited Federal interference with administration of institutions where grants were made for construction of
health research facilities, prior to repeal by Pub. L.
94–484, title II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 708 of act July 1, 1944, was classified
to section 292h of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
EFFECTIVE DATE
Section effective Jan. 1, 1993, and until such date,
former section 294e(c) of this title, as in effect on the
day before Oct. 13, 1992, to continue in effect in lieu of
this section, see section 103 of Pub. L. 102–408, set out
as a note under section 292 of this title.

§ 292h. Office for Health Education Assistance
Loan Default Reduction
(a) Establishment
The Secretary shall establish, within the Division of Student Assistance of the Bureau of
Health Professions, an office to be known as the
Office for Health Education Assistance Loan Default Reduction (in this section referred to as
the ‘‘Office’’).
(b) Purpose and functions
It shall be the purpose of the Office to achieve
a reduction in the number and amounts of defaults on loans guaranteed under this subpart.
In carrying out such purpose the Office shall—

Page 762

(1) conduct analytical and evaluative studies
concerning loans and loan defaults;
(2) carry out activities designed to reduce
loan defaults;
(3) respond to special circumstances that
may exist in the financial lending environment that may lead to loan defaults;
(4) coordinate with other Federal entities
that are involved with student loan programs,
including—
(A) with respect to the Department of Education, in the development of a single student loan application form, a single student
loan deferment form, a single disability
form, and a central student loan database;
and
(B) with respect to the Department of Justice, in the recovery of payments from
health professionals who have defaulted on
loans guaranteed under this subpart; and
(5) provide technical assistance to borrowers, lenders, holders, and institutions concerning deferments and collection activities.
(c) Additional duties
In conjunction with the report submitted
under subsection (b) of this section, the Office
shall—
(1) compile, and publish in the Federal Register, a list of the borrowers who are in default
under this subpart; and
(2) send the report and notices of default
with respect to these borrowers to relevant
Federal agencies and to schools, school associations, professional and specialty associations, State licensing boards, hospitals with
which such borrowers may be associated, and
any other relevant organizations.
(d) Allocation of funds for Office
In the case of amounts reserved under section
292i(a)(2)(B) of this title for obligation under
this subsection, the Secretary may obligate the
amounts for the purpose of administering the
Office, including 7 full-time equivalent employment positions for such Office. With respect to
such purpose, amounts made available under the
preceding sentence are in addition to amounts
made available to the Health Resources and
Services Administration for program management for the fiscal year involved. With respect
to such employment positions, the positions are
in addition to the number of full-time equivalent employment positions that otherwise is authorized for the Department of Health and
Human Services for the fiscal year involved.
(July 1, 1944, ch. 373, title VII, § 709, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2006; amended Pub. L. 105–392, title I,
§ 141(b), Nov. 13, 1998, 112 Stat. 3579.)
PRIOR PROVISIONS
A prior section 292h, act July 1, 1944, ch. 373, title VII,
§ 708, as added Oct. 12, 1976, Pub. L. 94–484, title II, § 206,
90 Stat. 2250; amended Aug. 1, 1977, Pub. L. 95–83, title
III, § 307(a), 91 Stat. 389; Nov. 9, 1978, Pub. L. 95–623,
§ 12(a), 92 Stat. 3457; Dec. 11, 1980, Pub. L. 96–511, § 4(c),
94 Stat. 2826; Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2719, 95 Stat. 914; Oct. 22, 1985, Pub. L. 99–129, title II,
§ 220(b), 99 Stat. 543; Nov. 4, 1988, Pub. L. 100–607, title
VI, §§ 616(c)(1), 626, 102 Stat. 3139, 3144; Nov. 18, 1988, Pub.
L. 100–690, title II, § 2615(a), 102 Stat. 4239; Aug. 16, 1989,

Page 763

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 101–93, § 5(m), 103 Stat. 613, related to health
professions data, prior to the general revision of this
subchapter by Pub. L. 102–408. See section 295k of this
title.
Another prior section 292h, act July 1, 1944, ch. 373,
title VII, § 709, as added July 30, 1956, ch. 779, § 2, 70 Stat.
720; amended Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164; Nov. 18, 1971, Pub. L. 92–157, title I, § 102(k)(2)(C), 85
Stat. 437, provided for issuance of general, administrative, and other regulations for implementation of
grants for construction of health research facilities,
prior to repeal by Pub. L. 94–484, title II, § 201(a), Oct.
12, 1976, 90 Stat. 2246.
A prior section 709 of act July 1, 1944, was classified
to section 292i of this title prior to repeal by Pub. L.
97–35, title XXVII, § 2720(a), Aug. 13, 1981, 95 Stat. 915.
AMENDMENTS
1998—Subsec. (b). Pub. L. 105–392 inserted ‘‘and’’ at
end of par. (4)(B), substituted a period for ‘‘; and’’ at
end of par. (5), and struck out par. (6) which read as follows: ‘‘prepare and submit a report not later than
March 31, 1993, and annually, thereafter, to the Committee on Labor and Human Resources of the Senate
and the Committee on Energy and Commerce of the
House of Representatives concerning—
‘‘(A) the default rates for each—
‘‘(i) institution described in section 292o(1) of this
title that is participating in the loan programs
under this subpart;
‘‘(ii) lender participating in the loan program
under this subpart; and
‘‘(iii) loan holder under this subpart;
‘‘(B) the total amounts recovered pursuant to section 292f(b) of this title during the preceding fiscal
year; and
‘‘(C) a plan for improving the extent of such recoveries during the current fiscal year.’’

§ 292i. Insurance account
(a) In general
(1) Establishment
There is hereby established a student loan
insurance account (in this section referred to
as the ‘‘Account’’) which shall be available
without fiscal year limitation to the Secretary for making payments in connection
with the collection and default of loans insured under this subpart by the Secretary.
(2) Funding
(A) Except as provided in subparagraph (B),
all amounts received by the Secretary as premium charges for insurance and as receipts,
earnings, or proceeds derived from any claim
or other assets acquired by the Secretary in
connection with his operations under this subpart, and any other moneys, property, or assets derived by the Secretary from the operations of the Secretary in connection with
this section, shall be deposited in the Account.
(B) With respect to amounts described in
subparagraph (A) that are received by the Secretary for fiscal year 1993 and subsequent fiscal years, the Secretary may, before depositing such amounts in the Account, reserve from
the amounts each such fiscal year not more
than $1,000,000 for obligation under section
292h(d) of this title.
(3) Expenditures
All payments in connection with the default
of loans insured by the Secretary under this
subpart shall be paid from the Account.

§ 292j

(b) Contingent authority for issuance of notes or
other obligations
If at any time the moneys in the Account are
insufficient to make payments in connection
with the collection or default of any loan insured by the Secretary under this subpart, the
Secretary of the Treasury may lend the Account
such amounts as may be necessary to make the
payments involved, subject to the Federal Credit Reform Act of 1990 [2 U.S.C. 661 et seq.].
(July 1, 1944, ch. 373, title VII, § 710, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2007; amended Pub. L. 105–392, title I, § 143,
Nov. 13, 1998, 112 Stat. 3581.)
REFERENCES IN TEXT
The Federal Credit Reform Act of 1990, referred to in
subsec. (b), is title V of Pub. L. 93–344, as added by Pub.
L. 101–508, title XIII, § 13201(a), Nov. 5, 1990, 104 Stat.
1388–609, which is classified generally to subchapter III
(§ 661 et seq.) of chapter 17A of Title 2, The Congress.
For complete classification of this Act to the Code, see
Short Title of 1990 Amendment note set out under section 621 of Title 2 and Tables.
PRIOR PROVISIONS
A prior section 292i, act July 1, 1944, ch. 373, title VII,
§ 709, as added Oct. 12, 1976, Pub. L. 94–484, title II, § 207,
90 Stat. 2252; amended Nov. 9, 1978, Pub. L. 95–623,
§ 12(b), 92 Stat. 3457, related to shared schedule residency training positions, prior to repeal by Pub. L.
97–35, title XXVII, § 2720(a), Aug. 13, 1981, 95 Stat. 915.
Another prior section 292i, act July 1, 1944, ch. 373,
title VII, § 710, as added July 30, 1956, ch. 779, § 2, 70 Stat.
720; amended Sept. 24, 1963, Pub. L. 88–129, § 2(a), 77 Stat.
164; Nov. 18, 1971, Pub. L. 92–157, title I, § 102(k)(2)(A), 85
Stat. 437, related to preparation and submission of annual reports to the Congress through the President, including its contents, as to grants for construction of
health research facilities, prior to repeal by Pub. L.
94–484, title II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
A prior section 710 of act July 1, 1944, was classified
to section 292k of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
Another prior section 710 of act July 1, 1944, was renumbered section 709 by Pub. L. 97–35 and was classified
to section 292j of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (a)(2)(B). Pub. L. 105–392 substituted
‘‘fiscal year 1993 and subsequent fiscal years’’ for ‘‘any
of the fiscal years 1993 through 1996’’.

§ 292j. Powers and responsibilities of Secretary
(a) In general
In the performance of, and with respect to, the
functions, powers, and duties vested in the Secretary by this subpart, the Secretary is authorized as follows:
(1) To prescribe such regulations as may be
necessary to carry out the purposes of this
subpart.
(2) To sue and be sued in any district court
of the United States. Such district courts shall
have jurisdiction of civil actions arising under
this subpart without regard to the amount in
controversy, and any action instituted under
this subsection by or against the Secretary
shall survive notwithstanding any change in
the person occupying the office of Secretary or
any vacancy in that office. No attachment, injunction, garnishment, or other similar proc-

§ 292k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ess, mesne or final, shall be issued against the
Secretary or property under the control of the
Secretary. Nothing herein shall be constructed
to except litigation arising out of activities
under this subpart from the application of sections 517 and 547 of title 28.
(3) To include in any contract for Federal
loan insurance such terms, conditions, and
covenants relating to repayment of principal
and payments of interest, relating to his obligations and rights and to those of eligible
lenders, and borrowers in case of default, and
relating to such other matters as the Secretary determines to be necessary to assure
that the purposes of this subpart will be
achieved. Any term, condition, and covenant
made pursuant to this paragraph or any other
provisions of this subpart may be modified by
the Secretary if the Secretary determines that
modification is necessary to protect the financial interest of the United States.
(4) Subject to the specific limitations in the
subpart, to consent to the modification of any
note or other instrument evidencing a loan
which has been insured by him under this subpart (including modifications with respect to
the rate of interest, time of payment of any
installment of principal and interest or any
portion thereof, or any other provision).
(5) To enforce, pay, compromise, waive, or
release any right, title, claim, lien, or demand,
however acquired, including any equity or any
right or 1 redemption.
(b) Annual budget; accounts
The Secretary shall, with respect to the financial operations arising by reason of this subpart—
(1) prepare annually and submit a budget
program as provided for wholly owned Government corporations by chapter 91 of title 31;
and
(2) maintain with respect to insurance under
this subpart an integral set of accounts.

Page 764

§ 292k. Participation by Federal credit unions in
Federal, State, and private student loan insurance programs
Notwithstanding any other provision of law,
Federal credit unions shall, pursuant to regulations of the Administrator of the National Credit Union Administration, have power to make
insured loans to eligible students in accordance
with the provisions of this subpart relating to
Federal insured loans.
(July 1, 1944, ch. 373, title VII, § 712, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2008.)
PRIOR PROVISIONS
A prior section 292k, act July 1, 1944, ch. 373, title VII,
§ 710, formerly § 711, as added Oct. 12, 1976, Pub. L.
94–484, title II, § 209, 90 Stat. 2253; renumbered § 710 and
amended Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§§ 2720(b), 2722, 95 Stat. 915, related to differential tuition and fees, prior to the general revision of this subchapter by Pub. L. 102–408.
TRANSFER OF FUNCTIONS
Functions vested in Administrator of National Credit
Union Administration transferred and vested in National Credit Union Administration Board pursuant to
section 1752a of Title 12, Banks and Banking.

§ 292l. Determination of eligible students
For purposes of determining eligible students
under this part, in the case of a public school in
a State that offers an accelerated, integrated
program of study combining undergraduate premedical education and medical education leading to advanced entry, by contractual agreement, into an accredited four-year school of
medicine which provides the remaining training
leading to a degree of doctor of medicine, whenever in this part a provision refers to a student
at a school of medicine, such reference shall include only a student enrolled in any of the last
four years of such accelerated, integrated program of study.

(July 1, 1944, ch. 373, title VII, § 711, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2007.)

(July 1, 1944, ch. 373, title VII, § 713, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2008.)

CODIFICATION

§ 292m. Repayment by Secretary of loans of deceased or disabled borrowers

In subsec. (b)(1), ‘‘chapter 91 of title 31’’ was substituted for ‘‘the Government Corporation Control
Act’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13, 1982,
96 Stat. 1067, the first section of which enacted Title 31,
Money and Finance.
PRIOR PROVISIONS
A prior section 292j, act July 1, 1944, ch. 373, title VII,
§ 709, formerly § 710, as added Oct. 12, 1976, Pub. L.
94–484, title II, § 208, 90 Stat. 2252; renumbered § 709 and
amended Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§§ 2720(b), 2721, 95 Stat. 915; Oct. 22, 1985, Pub. L. 99–129,
title II, § 206, 99 Stat. 527, related to payment under
grants, prior to the general revision of this subchapter
by Pub. L. 102–408.
Another prior section 292j, act July 1, 1944, ch. 373,
title VII, § 711, as added Sept. 24, 1963, Pub. L. 88–129,
§ 3(b), 77 Stat. 173; amended Nov. 18, 1971, Pub. L. 92–157,
title I, § 102(k)(2)(A), 85 Stat. 437, provided for technical
assistance in connection with grants for construction
of health research facilities, prior to repeal by Pub. L.
94–484, title II, § 201(a), Oct. 12, 1976, 90 Stat. 2246.
1 So

in original. Probably should be ‘‘of’’.

If a borrower who has received a loan dies or
becomes permanently and totally disabled (as
determined in accordance with regulations of
the Secretary), the Secretary shall discharge
the borrower’s liability on the loan by repaying
the amount owed on the loan from the account
established under section 292i of this title.
(July 1, 1944, ch. 373, title VII, § 714, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2008.)
§ 292n. Additional requirements for institutions
and lenders
(a) In general
Notwithstanding any other provision of this
subpart, the Secretary is authorized to prescribe
such regulations as may be necessary to provide
for—
(1) a fiscal audit of an eligible institution
with regard to any funds obtained from a bor-

Page 765

TITLE 42—THE PUBLIC HEALTH AND WELFARE

rower who has received a loan insured under
this subpart;
(2) the establishment of reasonable standards of financial responsibility and appropriate institutional capability for the administration by an eligible institution of a program
of student financial aid with respect to funds
obtained from a student who has received a
loan insured under this subpart;
(3) the limitation, suspension, or termination of the eligibility under this subpart of
any otherwise eligible institution, whenever
the Secretary has determined, after notice and
affording an opportunity for hearing, that
such institution has violated or failed to carry
out any regulation prescribed under this subpart;
(4) the collection of information from the
borrower, lender, or eligible institution to assure compliance with the provisions of section
292d of this title;
(5) the assessing of tuition or fees to borrowers in amounts that are the same or less than
the amount of tuition and fees assessed to
nonborrowers;
(6) the submission, by the institution or the
lender to the Office of Health Education Assistance Loan Default Reduction, of information concerning each loan made under this
subpart, including the date when each such
loan was originated, the date when each such
loan is sold, the identity of the loan holder
and information concerning a change in the
borrower’s status;
(7) the withholding of services, including
academic transcripts, financial aid transcripts, and alumni services, by an institution
from a borrower upon the default of such borrower of a loan under this subpart, except in
case of a borrower who has filed for bankruptcy; and
(8) the offering, by the lender to the borrower, of a variety of repayment options, including fixed-rate, graduated repayment with
negative amortization permitted, and income
dependent payments for a limited period followed by level monthly payments.
(b) Recording by institution of information on
students
The Secretary shall require an eligible institution to record, and make available to the lender
and to the Secretary upon request, the name,
address, postgraduate destination, and other
reasonable identifying information for each student of such institution who has a loan insured
under this subpart.
(c) Workshop for student borrowers
Each participating eligible institution must
have, at the beginning of each academic year, a
workshop concerning the provisions of this subpart that all student borrowers shall be required
to attend.
(July 1, 1944, ch. 373, title VII, § 715, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2009.)
§ 292o. Definitions
For purposes of this subpart:
(1) The term ‘‘eligible institution’’ means,
with respect to a fiscal year, a school of medi-

§ 292o

cine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine,
pharmacy, public health, allied health, or
chiropractic, or a graduate program in health
administration or behavioral and mental
health practice, including clinical psychology.
(2) The term ‘‘eligible lender’’ means an eligible institution that became a lender under
this subpart prior to September 15, 1992, an
agency or instrumentality of a State, a financial or credit institution (including an insurance company) which is subject to examination and supervision by an agency of the
United States or of any State, a pension fund
approved by the Secretary for this purpose, or
a nonprofit private entity designated by the
State, regulated by the State, and approved by
the Secretary.
(3) The term ‘‘line of credit’’ means an arrangement or agreement between the lender
and the borrower whereby a loan is paid out by
the lender to the borrower in annual installments, or whereby the lender agrees to make,
in addition to the initial loan, additional loans
in subsequent years.
(4) The term ‘‘school of allied health’’ means
a program in a school of allied health (as defined in section 295p of this title) which leads
to a masters’ degree or a doctoral degree.
(5)(A) The term ‘‘default rate’’, in the case of
an eligible entity, means the percentage constituted by the ratio of—
(i) the principal amount of loans insured
under this subpart—
(I) that are made with respect to the entity and that enter repayment status after
April 7, 1987; and
(II) for which amounts have been paid
under section 292f(a) of this title to insurance beneficiaries, exclusive of any loan
for which amounts have been so paid as a
result of the death or total and permanent
disability of the borrower; exclusive of any
loan for which the borrower begins payments to the Secretary on the loan pursuant to section 292f(b) of this title and
maintains payments for 12 consecutive
months in accordance with the agreement
involved (with the loan subsequently being
included or excluded, as the case may be,
as amounts paid under section 292f(a) of
this title according to whether further defaults occur and whether with respect to
the default involved compliance with such
requirement regarding 12 consecutive
months occurs); and exclusive of any loan
on which payments may not be recovered
by reason of the obligation under the loan
being discharged in bankruptcy under title
11; to
(ii) the total principal amount of loans insured under this subpart that are made with
respect to the entity and that enter repayment status after April 7, 1987.
(B) For purposes of subparagraph (A), a loan
insured under this subpart shall be considered
to have entered repayment status if the applicable period described in subparagraph (B) of
section 292d(a)(2) of this title regarding the
loan has expired (without regard to whether

§ 292p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

any period described in subparagraph (C) of
such section is applicable regarding the loan).
(C) For purposes of subparagraph (A), the
term ‘‘eligible entity’’ means an eligible institution, an eligible lender, or a holder, as the
case may be.
(D) For purposes of subparagraph (A), a loan
is made with respect to an eligible entity if—
(i) in the case of an eligible institution,
the loan was made to students of the institution;
(ii) in the case of an eligible lender, the
loan was made by the lender; and
(iii) in the case of a holder, the loan was
purchased by the holder.
(July 1, 1944, ch. 373, title VII, § 719, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2009; amended Pub. L. 105–392, title I,
§ 141(c)(2), Nov. 13, 1998, 112 Stat. 3579.)
AMENDMENTS
1998—Par. (1). Pub. L. 105–392 substituted ‘‘or behavioral and mental health practice, including clinical
psychology’’ for ‘‘or clinical psychology’’.

§ 292p. Authorization of appropriations
(a) In general
For fiscal year 1993 and subsequent fiscal
years, there are authorized to be appropriated
such sums as may be necessary for the adequacy
of the student loan insurance account under this
subpart and for the purpose of administering
this subpart.
(b) Availability of sums
Sums appropriated under subsection (a) of this
section shall remain available until expended.
(July 1, 1944, ch. 373, title VII, § 720, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2011.)
PRIOR PROVISIONS
A prior section 720 of act July 1, 1944, was classified
to section 293 of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
SUBPART II—FEDERALLY-SUPPORTED STUDENT
LOAN FUNDS

§ 292q. Agreements for operation of school loan
funds
(a) Fund agreements
The Secretary is authorized to enter into an
agreement for the establishment and operation
of a student loan fund in accordance with this
subpart with any public or other nonprofit
school of medicine, osteopathic medicine, dentistry, pharmacy, podiatric medicine, optometry, or veterinary medicine.
(b) Requirements
Each agreement entered into under this section shall—
(1) provide for establishment of a student
loan fund by the school;
(2) provide for deposit in the fund of—
(A) the Federal capital contributions to
the fund;
(B) an amount equal to not less than oneninth of such Federal capital contributions,
contributed by such institution;

Page 766

(C) collections of principal and interest on
loans made from the fund;
(D) collections pursuant to section 292r(j)
of this title; and
(E) any other earnings of the fund;
(3) provide that the fund shall be used only
for loans to students of the school in accordance with the agreement and for costs of collection of such loans and interest thereon;
(4) provide that loans may be made from
such funds only to students pursuing a fulltime course of study at the school leading to
a degree of doctor of medicine, doctor of dentistry or an equivalent degree, doctor of osteopathy, bachelor of science in pharmacy or an
equivalent degree, doctor of pharmacy or an
equivalent degree, doctor of podiatric medicine or an equivalent degree, doctor of optometry or an equivalent degree, or doctor of veterinary medicine or an equivalent degree;
(5) provide that the school shall advise, in
writing, each applicant for a loan from the
student loan fund of the provisions of section
292r of this title under which outstanding
loans from the student loan fund may be paid
(in whole or in part) by the Secretary; and
(6) contain such other provisions as are necessary to protect the financial interests of the
United States.
(c) Failure of school to collect loans
(1) In general
Any standard established by the Secretary
by regulation for the collection by schools of
medicine, osteopathic medicine, dentistry,
pharmacy, podiatric medicine, optometry, or
veterinary medicine of loans made pursuant to
loan agreements under this subpart shall provide that the failure of any such school to collect such loans shall be measured in accordance with this subsection. This subsection
may not be construed to require such schools
to reimburse the student loan fund under this
subpart for loans that became uncollectible
prior to August 1985 or to penalize such
schools with respect to such loans.
(2) Extent of failure
The measurement of a school’s failure to
collect loans made under this subpart shall be
the ratio (stated as a percentage) that the defaulted principal amount outstanding of such
school bears to the matured loans of such
school.
(3) Definitions
For purposes of this subsection:
(A) The term ‘‘default’’ means the failure
of a borrower of a loan made under this subpart to—
(i) make an installment payment when
due; or
(ii) comply with any other term of the
promissory note for such loan,
except that a loan made under this subpart
shall not be considered to be in default if the
loan is discharged in bankruptcy or if the
school reasonably concludes from written
contracts with the borrower that the borrower intends to repay the loan.
(B) The term ‘‘defaulted principal amount
outstanding’’ means the total amount bor-

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rowed from the loan fund of a school that
has reached the repayment stage (minus any
principal amount repaid or canceled) on
loans—
(i) repayable monthly and in default for
at least 120 days; and
(ii) repayable less frequently than
monthly and in default for at least 180
days;
(C) The term ‘‘grace period’’ means the period of one year beginning on the date on
which the borrower ceases to pursue a fulltime course of study at a school of medicine,
osteopathic medicine, dentistry, pharmacy,
podiatric medicine, optometry, or veterinary
medicine; and
(D) The term ‘‘matured loans’’ means the
total principal amount of all loans made by
a school under this subpart minus the total
principal amount of loans made by such
school to students who are—
(i) enrolled in a full-time course of study
at such school; or
(ii) in their grace period.
(July 1, 1944, ch. 373, title VII, § 721, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2011.)
PRIOR PROVISIONS
A prior section 721 of act July 1, 1944, was classified
to section 293a of this title prior to the general revision
of this subchapter by Pub. L. 102–408.

§ 292r. Loan provisions
(a) Amount of loan
(1) In general
Loans from a student loan fund (established
under an agreement with a school under section 292q of this title) may not, subject to
paragraph (2), exceed for any student for a
school year (or its equivalent) the cost of attendance (including tuition, other reasonable
educational expenses, and reasonable living
costs) for that year at the educational institution attended by the student (as determined
by such educational institution).
(2) Third and fourth years of medical school
For purposes of paragraph (1), the amount of
the loan may, in the case of the third or fourth
year of a student at a school of medicine or osteopathic medicine, be increased to the extent
necessary to pay the balances of loans that,
from sources other than the student loan fund
under section 292q of this title, were made to
the individual for attendance at the school.
The authority to make such an increase is
subject to the school and the student agreeing
that such amount (as increased) will be expended to pay such balances.
(b) Terms and conditions
Subject to section 292s of this title, any such
loans shall be made on such terms and conditions as the school may determine, but may be
made only to a student—
(1) who is in need of the amount thereof to
pursue a full-time course of study at the
school leading to a degree of doctor of medicine, doctor of dentistry or an equivalent de-

§ 292r

gree, doctor of osteopathy, bachelor of science
in pharmacy or an equivalent degree, doctor of
pharmacy or an equivalent degree, doctor of
podiatric medicine or an equivalent degree,
doctor of optometry or an equivalent degree,
or doctor of veterinary medicine or an equivalent degree; and
(2) who, if required under section 453 of title
50, Appendix, to present himself for and submit to registration under such section, has
presented himself and submitted to registration under such section.
(c) Repayment; exclusions from repayment period
Such loans shall be repayable in equal or graduated periodic installments (with the right of
the borrower to accelerate repayment) over the
period of not less than 10 years nor more than 25
years, at the discretion of the institution, which
begins one year after the student ceases to pursue a full-time course of study at a school of
medicine, osteopathic medicine, dentistry, pharmacy, podiatry, optometry, or veterinary medicine, excluding from such period—
(1) all periods—
(A) not in excess of three years of active
duty performed by the borrower as a member
of a uniformed service;
(B) not in excess of three years during
which the borrower serves as a volunteer
under the Peace Corps Act [22 U.S.C. 2501 et
seq.];
(C) during which the borrower participates
in advanced professional training, including
internships and residencies; and
(D) during which the borrower is pursuing
a full-time course of study at such a school;
and
(2) a period—
(A) not in excess of two years during which
a borrower who is a full-time student in such
a school leaves the school, with the intent to
return to such school as a full-time student,
in order to engage in a full-time educational
activity which is directly related to the
health profession for which the borrower is
preparing, as determined by the Secretary;
or
(B) not in excess of two years during which
a borrower who is a graduate of such a
school is a participant in a fellowship training program or a full-time educational activity which—
(i) is directly related to the health profession for which such borrower prepared
at such school, as determined by the Secretary; and
(ii) may be engaged in by the borrower
during such a two-year period which begins within twelve months after the completion of the borrower’s participation in
advanced professional training described
in paragraph (1)(C) or prior to the completion of such borrower’s participation in
such training.
(d) Cancellation of liability
The liability to repay the unpaid balance of
such a loan and accrued interest thereon shall
be canceled upon the death of the borrower, or if

§ 292r

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Secretary determines that he has become
permanently, and totally disabled.
(e) Rate of interest
Such loans shall bear interest, on the unpaid
balance of the loan, computed only for periods
for which the loan is repayable, at the rate of 5
percent per year.
(f) Security or endorsement
Loans shall be made under this subpart without security or endorsement, except that if the
borrower is a minor and the note or other evidence of obligation executed by him would not,
under the applicable law, create a binding obligation, either security or endorsement may be
required.
(g) Transferring and assigning loans
No note or other evidence of a loan made
under this subpart may be transferred or assigned by the school making the loan except
that, if the borrowers transfer to another school
participating in the program under this subpart,
such note or other evidence of a loan may be
transferred to such other school.
(h) Charge with respect to insurance for certain
cancellations
Subject to regulations of the Secretary, a
school may assess a charge with respect to loans
made this subpart 1 to cover the costs of insuring
against cancellation of liability under subsection (d) of this section.
(i) Charge with respect to late payments
Subject to regulations of the Secretary, and in
accordance with this section, a school shall assess a charge with respect to a loan made under
this subpart for failure of the borrower to pay
all or any part of an installment when it is due
and, in the case of a borrower who is entitled to
deferment of the loan under subsection (c) of
this section, for any failure to file timely and
satisfactory evidence of such entitlement. No
such charge may be made if the payment of such
installment or the filing of such evidence is
made within 60 days after the date on which
such installment or filing is due. The amount of
any such charge may not exceed an amount
equal to 6 percent of the amount of such installment. The school may elect to add the amount
of any such charge to the principal amount of
the loan as of the first day after the day on
which such installment or evidence was due, or
to make the amount of the charge payable to
the school not later than the due date of the
next installment after receipt by the borrower
of notice of the assessment of the charge.
(j) Authority of schools regarding rate of payment
A school may provide, in accordance with regulations of the Secretary, that during the repayment period of a loan from a loan fund established pursuant to an agreement under this subpart payments of principal and interest by the
borrower with respect to all the outstanding
loans made to him from loan funds so established shall be at a rate equal to not less than
$40 per month.
1 So

in original. Probably should be ‘‘under this subpart’’.

Page 768

(k) Authority regarding repayments by Secretary
Upon application by a person who received,
and is under an obligation to repay, any loan
made to such person as a health professions student to enable him to study medicine, osteopathy, dentistry, veterinary medicine, optometry, pharmacy, or podiatry, the Secretary may
undertake to repay (without liability to the applicant) all or any part of such loan, and any interest or portion thereof outstanding thereon,
upon his determination, pursuant to regulations
establishing criteria therefor, that the applicant—
(1) failed to complete such studies leading to
his first professional degree;
(2) is in exceptionally needy circumstances;
(3) is from a low-income or disadvantaged
family as those terms may be defined by such
regulations; and
(4) has not resumed, or cannot reasonably be
expected to resume, the study of medicine, osteopathy, dentistry, veterinary medicine, optometry, pharmacy, or podiatric medicine,
within two years following the date upon
which he terminated such studies.
(l) Collection efforts by Secretary
The Secretary is authorized to attempt to collect any loan which was made under this subpart, which is in default, and which was referred
to the Secretary by a school with which the Secretary has an agreement under this subpart, on
behalf of that school under such terms and conditions as the Secretary may prescribe (including reimbursement from the school’s student
loan fund for expenses the Secretary may reasonably incur in attempting collection), but
only if the school has complied with such requirements as the Secretary may specify by regulation with respect to the collection of loans
under this subpart. A loan so referred shall be
treated as a debt subject to section 5514 of title
5. Amounts collected shall be deposited in the
school’s student loan fund. Whenever the Secretary desires the institution of a civil action
regarding any such loan, the Secretary shall
refer the matter to the Attorney General for appropriate action.
(m) Elimination of statute of limitation for loan
collections
(1) Purpose
It is the purpose of this subsection to ensure
that obligations to repay loans under this section are enforced without regard to any Federal or State statutory, regulatory, or administrative limitation on the period within
which debts may be enforced.
(2) Prohibition
Notwithstanding any other provision of Federal or State law, no limitation shall terminate the period within which suit may be filed,
a judgment may be enforced, or an offset, garnishment, or other action may be initiated or
taken by a school that has an agreement with
the Secretary pursuant to section 292q of this
title that is seeking the repayment of the
amount due from a borrower on a loan made
under this subpart after the default of the borrower on such loan.

Page 769

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title VII, § 722, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2012; amended Pub. L. 103–43, title XX,
§ 2014(b), June 10, 1993, 107 Stat. 215; Pub. L.
105–392, title I, § 134(a), (b)(1), Nov. 13, 1998, 112
Stat. 3577, 3578.)
REFERENCES IN TEXT
The Peace Corps Act, referred to in subsec. (c)(1)(B),
is Pub. L. 87–293, Sept. 22, 1961, 75 Stat. 612, as amended,
which is classified principally to chapter 34 (§ 2501 et
seq.) of Title 22, Foreign Relations and Intercourse. For
complete classification of this Act to the Code, see
Short Title note set out under section 2501 of Title 22
and Tables.
PRIOR PROVISIONS
A prior section 722 of act July 1, 1944, was classified
to section 293b of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (a)(1). Pub. L. 105–392, § 134(a)(1), substituted ‘‘the cost of attendance (including tuition,
other reasonable educational expenses, and reasonable
living costs) for that year at the educational institution attended by the student (as determined by such
educational institution).’’ for ‘‘the sum of—
‘‘(A) the cost of tuition for such year at such
school, and
‘‘(B) $2,500.’’
Subsec. (a)(2). Pub. L. 105–392, § 134(a)(2), substituted
‘‘the amount of the loan may, in the case of the third
or fourth year of a student at a school of medicine or
osteopathic medicine, be increased to the extent necessary’’ for ‘‘the amount $2,500 may, in the case of the
third or fourth year of a student at school of medicine
or osteopathic medicine, be increased to the extent
necessary (including such $2,500)’’.
Subsec. (c). Pub. L. 105–392, § 134(a)(3), in heading, substituted ‘‘repayment’’ for ‘‘ten-year’’ and, in introductory provisions, substituted ‘‘period of not less than 10
years nor more than 25 years, at the discretion of the
institution, which begins’’ for ‘‘ten-year period which
begins’’ and ‘‘such period’’ for ‘‘such ten-year period’’.
Subsec. (j). Pub. L. 105–392, § 134(a)(4), substituted
‘‘$40’’ for ‘‘$15’’.
Subsec. (m). Pub. L. 105–392, § 134(b)(1), added subsec.
(m).
1993—Subsec. (a). Pub. L. 103–43, § 2014(b)(1), amended
heading and text of subsec. (a) generally. Prior to
amendment, text read as follows: ‘‘Loans from a student loan fund (established under an agreement with a
school under section 292q of this title) may not exceed
for any student for each school year (or its equivalent)
the sum of—
‘‘(1) the cost of tuition for such year at such school,
and
‘‘(2) $2,500.’’
Subsec. (b)(2), (3). Pub. L. 103–43, § 2014(b)(2), redesignated par. (3) as (2) and struck out former par. (2),
which read as follows: ‘‘who, if pursuing a full-time
course of study at the school leading to a degree of doctor of medicine or doctor of osteopathy, is of exceptional financial need (as defined by regulations of the
Secretary); and’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–392, title I, § 134(b)(2), Nov. 13, 1998, 112
Stat. 3578, provided that: ‘‘The amendment made by
paragraph (1) [amending this section] shall be effective
with respect to actions pending on or after the date of
enactment of this Act [Nov. 13, 1998].’’

§ 292s. Medical schools and primary health care
(a) Requirements for students
(1) In general
Subject to the provisions of this subsection,
in the case of student loan funds established

§ 292s

under section 292q of this title by schools of
medicine or osteopathic medicine, each agreement entered into under such section with
such a school shall provide (in addition to the
provisions required in subsection (b) of such
section) that the school will make a loan from
such fund to a student only if the student
agrees—
(A) to enter and complete a residency
training program in primary health care not
later than 4 years after the date on which
the student graduates from such school; and
(B) to practice in such care for 10 years
(including residency training in primary
health care) or through the date on which
the loan is repaid in full, whichever occurs
first.
(2) Inapplicability to certain students
(A) The requirement established in paragraph (1) regarding the student loan fund of a
school does not apply to a student if—
(i) the first loan to the student from such
fund is made before July 1, 1993; or
(ii) the loan is made from—
(I) a Federal capital contribution under
section 292q of this title that is made from
amounts
appropriated
under
section
292t(f) 1 of this title (in this section referred to as an ‘‘exempt Federal capital
contribution’’); or
(II) a school contribution made under
section 292q of this title pursuant to such
a Federal capital contribution (in this section referred to as an ‘‘exempt school contribution’’).
(B) A Federal capital contribution under section 292q of this title may not be construed as
being an exempt Federal capital contribution
if the contribution was made from amounts
appropriated before October 1, 1990. A school
contribution under section 292q of this title
may not be construed as being an exempt
school contribution if the contribution was
made pursuant to a Federal capital contribution under such section that was made from
amounts appropriated before such date.
(3) Noncompliance by student
Each agreement entered into with a student
pursuant to paragraph (1) shall provide that, if
the student fails to comply with such agreement, the loan involved will begin to accrue
interest at a rate of 2 percent per year greater
than the rate at which the student would pay
if compliant in such year.
(4) Waivers
(A) With respect to the obligation of an individual under an agreement made under paragraph (1) as a student, the Secretary shall provide for the partial or total waiver or suspension of the obligation whenever compliance by
the individual is impossible, or would involve
extreme hardship to the individual, and if enforcement of the obligation with respect to
the individual would be unconscionable.
(B) For purposes of subparagraph (A), the obligation of an individual shall be waived if—
1 See

References in Text note below.

§ 292s

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) the status of the individual as a student
of the school involved is terminated before
graduation from the school, whether voluntarily or involuntarily; and
(ii) the individual does not, after such termination, resume attendance at the school
or begin attendance at any other school of
medicine or osteopathic medicine.
(C) If an individual resumes or begins attendance for purposes of subparagraph (B), the
obligation of the individual under the agreement under paragraph (1) shall be considered
to have been suspended for the period in which
the individual was not in attendance.
(D) This paragraph may not be construed as
authorizing the waiver or suspension of the obligation of a student to repay, in accordance
with section 292r of this title, loans from student loan funds under section 292q of this title.
(b) Requirements for schools
(1) In general
Subject to the provisions of this subsection,
in the case of student loan funds established
under section 292q of this title by schools of
medicine or osteopathic medicine, each agreement entered into under such section with
such a school shall provide (in addition to the
provisions required in subsection (b) of such
section) that, for the 1-year period ending on
June 30, 1997; 2 and for the 1-year period ending
on June 30 of each subsequent fiscal year, the
school will meet not less than 1 of the conditions described in paragraph (2) with respect
to graduates of the school whose date of graduation from the school occurred approximately 4 years before the end of the 1-year period involved.
(2) Description of conditions
With respect to graduates described in paragraph (1) (in this paragraph referred to as
‘‘designated graduates’’), the conditions referred to in such paragraph for a school for a
1-year period are as follows:
(A) Not less than 50 percent of designated
graduates of the school meet the criterion of
either being in a residency training program
in primary health care, or being engaged in
a practice in such care (having completed
such a program).
(B) Not less than 25 percent of the designated graduates of the school meet such
criterion, and such percentage is not less
than 5 percentage points above the percentage of such graduates meeting such criterion
for the preceding 1-year period.
(C) In the case of schools of medicine or osteopathic medicine with student loans funds
under section 292q of this title, the school involved is at or above the 75th percentile of
such schools whose designated graduates
meet such criterion.
(3) Determinations by Secretary
Not later than 90 days after the close of each
1-year period described in paragraph (1), the
Secretary shall make a determination of
whether the school involved has for such pe2 So

in original. The semicolon probably should be a comma.

Page 770

riod complied with such paragraph and shall
in writing inform the school of the determination. Such determination shall be made only
after consideration of the report submitted to
the Secretary by the school under paragraph
(6).
(4) Noncompliance by school
(A)(i) Subject to subparagraph (C), each
agreement under section 292q of this title with
a school of medicine or osteopathic medicine
shall provide that, if the school fails to comply with paragraph (1) for a 1-year period
under such paragraph, the school—
(I) will pay to the Secretary the amount
applicable under subparagraph (B) for the
period; and
(II) will pay such amount not later than 90
days after the school is informed under paragraph (3) of the determination of the Secretary regarding such period.
(ii) Any amount that a school is required to
pay under clause (i) may be paid from the student loan fund of the school under section 292q
of this title.
(B) For purposes of subparagraph (A), the
amount applicable for a school, subject to subparagraph (C), is—
(i) for the 1-year period ending June 30,
1997, an amount equal to 10 percent of the income received during such period by the student loan fund of the school under section
292q of this title;
(ii) for the 1-year period ending June 30,
1998, an amount equal to 20 percent of the income received during such period by the student loan fund; and
(iii) for any subsequent 1-year period under
paragraph (1), an amount equal to 30 percent
of the income received during such period by
the student loan fund.
(C) In determining the amount of income
that a student loan fund has received for purposes of subparagraph (B), the Secretary shall
exclude any income derived from exempt contributions. Payments made to the Secretary
under subparagraph (A) may not be made with
such contributions or with income derived
from such contributions.
(5) Expenditure of payments
(A) Amounts paid to the Secretary under
paragraph (4) shall be expended to make Federal capital contributions to student loan
funds under section 292q of this title of schools
that are in compliance with paragraph (1).
(B) A Federal capital contribution under section 292q of this title may not be construed as
being an exempt Federal capital contribution
if the contribution is made from payments
under subparagraph (A). A school contribution
under such section may not be construed as
being an exempt school contribution if the
contribution is made pursuant to a Federal
capital contribution from such payments.
(6) Reports by schools
Each agreement under section 292q of this
title with a school of medicine or osteopathic
medicine shall provide that the school will
submit to the Secretary a report for each 1-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

year period under paragraph (1) that provides
such information as the Secretary determines
to be necessary for carrying out this subsection. Each such report shall include statistics concerning the current training or practice status of all graduates of such school
whose date of graduation from the school occurred approximately 4 years before the end of
the 1-year period involved.
(c) Definitions
For purposes of this section:
(1) The term ‘‘exempt contributions’’ means
exempt Federal capital contributions and exempt school contributions.
(2) The term ‘‘exempt Federal capital contribution’’ means a Federal capital contribution described in subclause (I) of subsection
(a)(2)(A)(ii) of this section.
(3) The term ‘‘exempt school contribution’’
means a school contribution described in subclause (II) of subsection (a)(2)(A)(ii) of this
section.
(4) The term ‘‘income’’, with respect to a
student fund under section 292q of this title,
means payments of principal and interest on
any loan made from the fund, and any other
earnings of the fund.
(5) The term ‘‘primary health care’’ means
family medicine, general internal medicine,
general pediatrics, preventive medicine, or osteopathic general practice.
(d) Sense of Congress
It is the sense of Congress that funds repaid
under the loan program under this section
should not be transferred to the Treasury of the
United States or otherwise used for any other
purpose other than to carry out this section.
(July 1, 1944, ch. 373, title VII, § 723, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2015; amended Pub. L. 103–43, title XX,
§ 2014(c), June 10, 1993, 107 Stat. 216; Pub. L.
105–392, title I, § 131, Nov. 13, 1998, 112 Stat. 3574;
Pub. L. 111–148, title V, § 5201(a), Mar. 23, 2010, 124
Stat. 606.)
REFERENCES IN TEXT
Section 292t(f) of this title, referred to in subsec.
(a)(2)(A)(ii)(I), contained provisions in par. (1) relating
to appropriation of funds for Federal capital contributions to student loan funds, prior to repeal by Pub. L.
105–392, title I, § 132(b), Nov. 13, 1998, 112 Stat. 3575, eff.
Oct. 1, 2002.
PRIOR PROVISIONS
A prior section 723 of act July 1, 1944, was classified
to section 293c of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
2010—Subsec. (a)(1)(B). Pub. L. 111–148, § 5201(a)(1)(A),
added subpar. (B) and struck out former subpar. (B)
which read as follows: ‘‘to practice in such care
through the date on which the loan is repaid in full.’’
Subsec. (a)(3). Pub. L. 111–148, § 5201(a)(1)(B), added
par. (3) and struck out former par. (3). Prior to amendment, text read as follows: ‘‘Each agreement entered
into with a student pursuant to paragraph (1) shall provide that, if the student fails to comply with such
agreement, the loan involved will begin to accrue interest at a rate of 18 percent per year beginning on the
date of such noncompliance.’’
Subsec. (d). Pub. L. 111–148, § 5201(a)(2), added subsec.
(d).

§ 292t

1998—Subsec. (a)(3). Pub. L. 105–392, § 131(b), reenacted
heading without change and amended text of par. (3)
generally. Prior to amendment, text read as follows:
‘‘Each agreement entered into with a student pursuant
to paragraph (1) shall provide that, if the student fails
to comply with the agreement—
‘‘(A) the balance due on the loan involved will be
immediately recomputed from the date of issuance at
an interest rate of 12 percent per year, compounded
annually; and
‘‘(B) the recomputed balance will be paid not later
than the expiration of the 3-year period beginning on
the date on which the student fails to comply with
the agreement.’’
Subsec. (b)(1). Pub. L. 105–392, § 131(a), substituted ‘‘4
years before’’ for ‘‘3 years before’’.
Subsecs. (c), (d). Pub. L. 105–392, § 131(c), redesignated
subsec. (d) as (c) and struck out heading and text of
subsec. (c). Text read as follows: ‘‘The Secretary shall
each fiscal year submit to the Committee on Energy
and Commerce of the House of Representatives, and the
Committee on Labor and Human Resources of the Senate, a report regarding the administration of this section, including the extent of compliance with the requirements of this section, during the preceding fiscal
year.’’
1993—Subsec. (a)(4). Pub. L. 103–43, § 2014(c)(1), added
par. (4).
Subsec. (b)(1). Pub. L. 103–43, § 2014(c)(2)(A), substituted ‘‘1997;’’ for ‘‘1994,’’ and ‘‘3 years before’’ for ‘‘4
years before’’.
Subsec. (b)(2)(B). Pub. L. 103–43, § 2014(c)(2)(B), substituted ‘‘25 percent’’ for ‘‘15 percent’’.
Subsec. (b)(4)(B). Pub. L. 103–43, § 2014(c)(2)(C), substituted ‘‘1997’’ for ‘‘1994’’ in cl. (i) and ‘‘1998’’ for ‘‘1995’’
in cl. (ii).
STUDENT LOAN GUIDELINES
Pub. L. 111–148, title V, § 5201(b), Mar. 23, 2010, 124
Stat. 607, provided that: ‘‘The Secretary of Health and
Human Services shall not require parental financial information for an independent student to determine financial need under section 723 of the Public Health
Service Act (42 U.S.C. 292s) and the determination of
need for such information shall be at the discretion of
applicable school loan officer. The Secretary shall
amend guidelines issued by the Health Resources and
Services Administration in accordance with the preceding sentence.’’

§ 292t. Individuals from disadvantaged backgrounds
(a) Fund agreements regarding certain amounts
With respect to amounts appropriated under
subsection (f) of this section, each agreement
entered into under section 292q of this title with
a school shall provide (in addition to the provisions required in subsection (b) of such section)
that—
(1) any Federal capital contribution made to
the student loan fund of the school from such
amounts, together with the school contribution appropriate under subsection (b)(2)(B) of
such section to the amount of the Federal capital contribution, will be utilized only for the
purpose of—
(A) making loans to individuals from disadvantaged backgrounds; and
(B) the costs of the collection of the loans
and interest on the loans; and
(2) collections of principal and interest on
loans made pursuant to paragraph (1), and any
other earnings of the student loan fund attributable to amounts that are in the fund pursuant to such paragraph, will be utilized only for
the purpose described in such paragraph.

§ 292u

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Minimum qualifications for schools
The Secretary may not make a Federal capital
contribution for purposes of subsection (a) of
this section for a fiscal year unless the health
professions school involved—
(1) is carrying out a program for recruiting
and retaining students from disadvantaged
backgrounds, including racial and ethnic minorities; and
(2) is carrying out a program for recruiting
and retaining minority faculty.
(c) Certain agreements regarding education of
students; date certain for compliance
The Secretary may not make a Federal capital
contribution for purposes of subsection (a) of
this section for a fiscal year unless the health
professions school involved agrees—
(1) to ensure that adequate instruction regarding minority health issues is provided for
in the curricula of the school;
(2) with respect to health clinics providing
services to a significant number of individuals
who are from disadvantaged backgrounds, including members of minority groups, to enter
into arrangements with 1 or more such clinics
for the purpose of providing students of the
school with experience in providing clinical
services to such individuals;
(3) with respect to public or nonprofit private secondary educational institutions and
undergraduate institutions of higher education, to enter into arrangements with 1 or
more such institutions for the purpose of carrying out programs regarding the educational
preparation of disadvantaged students, including minority students, to enter the health professions and regarding the recruitment of such
individuals into the health professions;
(4) to establish a mentor program for assisting disadvantaged students, including minority students, regarding the completion of the
educational requirements for degrees from the
school;
(5) to be carrying out each of the activities
specified in any of paragraphs (1) through (4)
by not later than 1 year after the date on
which the first Federal capital contribution is
made to the school for purposes of subsection
(a) of this section; and
(6) to continue carrying out such activities,
and the activities specified in paragraphs (1)
and (2) of subsection (b) of this section,
throughout the period during which the student loan fund established pursuant to section
292q(b) of this title is in operation.
(d) Availability of other amounts
With respect to Federal capital contributions
to student loan funds under agreements under
section 292q(b) of this title, any such contributions made before October 1, 1990, together with
the school contributions appropriate under paragraph (2)(B) of such section to the amount of the
Federal capital contributions, may be utilized
for the purpose of making loans to individuals
from disadvantaged backgrounds, subject to section 292s(a)(2)(B) of this title.
(e) ‘‘Disadvantaged’’ defined
For purposes of this section, the term ‘‘disadvantaged’’, with respect to an individual,
shall be defined by the Secretary.

Page 772

(f) Authorization of appropriations
(1) Repealed. Pub. L. 105–392, title I, § 132(b),
Nov. 13, 1998, 112 Stat. 3575
(2) Special consideration for certain schools
In making Federal capital contributions to
student loan funds for purposes of subsection
(a) of this section, the Secretary shall give
special consideration to health professions
schools that have enrollments of underrepresented minorities above the national average for health professions schools.
(July 1, 1944, ch. 373, title VII, § 724, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2018; amended Pub. L. 105–392, title I, § 132,
Nov. 13, 1998, 112 Stat. 3575.)
PRIOR PROVISIONS
A prior section 724 of act July 1, 1944, was classified
to section 293d of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (f)(1). Pub. L. 105–392, § 132(b), struck out
heading and text of par. (1). Text read as follows: ‘‘With
respect to making Federal capital contributions to student loan funds for purposes of subsection (a) of this
section, there is authorized to be appropriated for such
contributions $8,000,000 for each of the fiscal years 1998
through 2002.’’
Pub. L. 105–392, § 132(a), substituted ‘‘$8,000,000 for
each of the fiscal years 1998 through 2002’’ for
‘‘$15,000,000 for fiscal year 1993’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–392, title I, § 132(b), Nov. 13, 1998, 112 Stat.
3575, provided that the repeal of subsec. (f)(1) of this
section is effective Oct. 1, 2002.

§ 292u. Administrative provisions
The Secretary may agree to modifications of
agreements or loans made under this subpart,
and may compromise, waive, or release any
right, title, claim, or demand of the United
States arising or acquired under this subpart.
(July 1, 1944, ch. 373, title VII, § 725, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2019.)
PRIOR PROVISIONS
A prior section 725 of act July 1, 1944, was classified
to section 293e of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
HEALTH PROFESSIONS EDUCATION FUND; AVAILABILITY
OF FUND; DEPOSIT IN FUND OF: INTEREST PAYMENTS
OR REPAYMENTS OF PRINCIPAL ON LOANS; TRANSFER
OF EXCESS MONEYS TO GENERAL FUND OF THE
TREASURY; AUTHORIZATION OF APPROPRIATIONS FOR
PAYMENTS UNDER AGREEMENTS
Section 406(b), (c) of Pub. L. 94–484 provided that:
‘‘(b) The health professions education fund created
within the Treasury by section 744(d)(1) of the Public
Health Service Act (as in effect before the date of enactment of this Act) [former section 294d(d)(1) of this
title] shall remain available to the Secretary of Health,
Education, and Welfare [now Health and Human Services] for the purpose of meeting his responsibilities respecting participations in obligations acquired under
such section. The Secretary shall continue to deposit in
such fund all amounts received by him as interest payments or repayments of principal on loans under such
section 744 [former section 294d of this title]. If at any

Page 773

TITLE 42—THE PUBLIC HEALTH AND WELFARE

time the Secretary determines the moneys in the fund
exceed the present and any reasonable prospective future requirements of such fund, such excess may be
transferred to the general fund of the Treasury.
‘‘(c) There are authorized to be appropriated without
fiscal year limitation such sums as may be necessary to
enable the Secretary to make payments under agreements entered into under section 744(b) [former section
294d(b) of this title] of the Public Health Service Act
before September 30, 1977.’’

§ 292v. Provision by schools of information to
students
(a) In general
With respect to loans made by a school under
this subpart after June 30, 1986, each school, in
order to carry out the provisions of sections 292q
and 292r of this title, shall, at any time such
school makes such a loan to a student under this
subpart, provide thorough and adequate loan information on loans made under this subpart to
the student. The loan information required to be
provided to the student by this subsection shall
include—
(1) the yearly and cumulative maximum
amounts that may be borrowed by the student;
(2) the terms under which repayment of the
loan will begin;
(3) the maximum number of years in which
the loan must be repaid;
(4) the interest rate that will be paid by the
borrower and the minimum amount of the required monthly payment;
(5) the amount of any other fees charged to
the borrower by the lender;
(6) any options the borrower may have for
deferral, cancellation, prepayment, consolidation, or other refinancing of the loan;
(7) a definition of default on the loan and a
specification of the consequences which will
result to the borrower if the borrower defaults,
including a description of any arrangements
which may be made with credit bureau organizations;
(8) to the extent practicable, the effect of accepting the loan on the eligibility of the borrower for other forms of student assistance;
and
(9) a description of the actions that may be
taken by the Federal Government to collect
the loan, including a description of the type of
information concerning the borrower that the
Federal Government may disclose to (A) officers, employees, or agents of the Department
of Health and Human Services, (B) officers,
employees, or agents of schools with which the
Secretary has an agreement under this subpart, or (C) any other person involved in the
collection of a loan under this subpart.
(b) Statement regarding loan
Each school shall, immediately prior to the
graduation from such school of a student who
receives a loan under this subpart after June 30,
1986, provide such student with a statement
specifying—
(1) each amount borrowed by the student
under this subpart;
(2) the total amount borrowed by the student under this subpart; and
(3) a schedule for the repayment of the
amounts borrowed under this subpart, includ-

§ 292x

ing the number, amount, and frequency of payments to be made.
(July 1, 1944, ch. 373, title VII, § 726, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2020.)
PRIOR PROVISIONS
A prior section 726 of act July 1, 1944, was classified
to section 293f of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
Another prior section 726 of act July 1, 1944, was classified to section 293f of this title prior to repeal by Pub.
L. 94–484.

§ 292w. Procedures for appeal of termination of
agreements
In any case in which the Secretary intends to
terminate an agreement with a school under
this subpart, the Secretary shall provide the
school with a written notice specifying such intention and stating that the school may request
a formal hearing with respect to such termination. If the school requests such a hearing
within 30 days after the receipt of such notice,
the Secretary shall provide such school with a
hearing conducted by an administrative law
judge.
(July 1, 1944, ch. 373, title VII, § 727, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2020.)
PRIOR PROVISIONS
A prior section 727 of act July 1, 1944, was classified
to section 294 of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
Another prior section 727 of act July 1, 1944, was classified to section 293g of this title prior to renumbering
by Pub. L. 94–484.

§ 292x. Distribution of assets from loan funds
(a) Distribution after termination of fund
If a school terminates a loan fund established
under an agreement pursuant to section 292q(b)
of this title, or if the Secretary for good cause
terminates the agreement with the school, there
shall be a capital distribution as follows:
(1) The Secretary shall first be paid an
amount which bears the same ratio to such
balance in such fund on the date of termination of the fund as the total amount of the
Federal capital contributions to such fund by
the Secretary pursuant to section 292q(b)(2)(A)
of this title bears to the total amount in such
fund derived from such Federal capital contributions and from funds deposited therein
pursuant to section 292q(b)(2)(B) of this title.
(2) The remainder of such balance shall be
paid to the school.
(b) Payment of proportionate share to Secretary
If a capital distribution is made under subsection (a) of this section, the school involved
shall, after the capital distribution, pay to the
Secretary, not less often than quarterly, the
same proportionate share of amounts received
by the school in payment of principal or interest
on loans made from the loan fund established
pursuant to section 292q(b) of this title as was
determined by the Secretary under subsection
(a) of this section.
(July 1, 1944, ch. 373, title VII, § 728, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2021.)

§ 292y

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 728 of act July 1, 1944, was classified
to section 294a of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
Another prior section 728 of act July 1, 1944, was classified to section 293h of this title prior to renumbering
by Pub. L. 94–484.

§ 292y. General provisions
(a) Date certain for applications
The Secretary shall from time to time set
dates by which schools must file applications for
Federal capital contributions.
(b) Contingent reduction in allotments
If the total of the amounts requested for any
fiscal year in such applications exceeds the
amounts appropriated under this section for
that fiscal year, the allotment to the loan fund
of each such school shall be reduced to whichever of the following is the smaller: (A) the
amount requested in its application; or (B) an
amount which bears the same ratio to the
amounts appropriated as the number of students
estimated by the Secretary to be enrolled in
such school during such fiscal year bears to the
estimated total number of students in all such
schools during such year. Amounts remaining
after allotment under the preceding sentence
shall be reallotted in accordance with clause (B)
of such sentence among schools whose applications requested more than the amounts so allotted to their loan funds, but with such adjustments as may be necessary to prevent the total
allotted to any such school’s loan fund from exceeding the total so requested by it.
(c) Allotment of excess funds
Funds available in any fiscal year for payment
to schools under this subpart which are in excess
of the amount appropriated pursuant to this section for that year shall be allotted among
schools in such manner as the Secretary determines will best carry out the purposes of this
subpart.
(d) Payment of installments to schools
Allotments to a loan fund of a school shall be
paid to it from time to time in such installments as the Secretary determines will not result in unnecessary accumulations in the loan
fund at such school.
(e) Disposition of funds returned to Secretary
(1) Expenditure for Federal capital contributions
Subject to section 292s(b)(5) of this title, any
amounts from student loan funds under section 292q of this title that are returned to the
Secretary by health professions schools shall
be expended to make Federal capital contributions to such funds.
(2) Date certain for contributions
Amounts described in paragraph (1) that are
returned to the Secretary shall be obligated
before the end of the succeeding fiscal year.
(3) Preference in making contributions
In making Federal capital contributions to
student loans funds under section 292q of this
title for a fiscal year from amounts described

Page 774

in paragraph (1), the Secretary shall give preference to health professions schools of the
same disciplines as the health professions
schools returning such amounts for the period
during which the amounts expended for such
contributions were received by the Secretary.
Any such amounts that, prior to being so returned, were available only for the purpose of
loans under this subpart to individuals from
disadvantaged backgrounds shall be available
only for such purpose.
(f) Funding for certain medical schools
(1) Authorization of appropriations
For the purpose of making Federal capital
contributions to student loan funds established under section 292q of this title by
schools of medicine or osteopathic medicine,
there is authorized to be appropriated
$10,000,000 for each of the fiscal years 1994
through 1996.
(2) Minimum requirements
(A) Subject to subparagraph (B), the Secretary may make a Federal capital contribution pursuant to paragraph (1) only if the
school of medicine or osteopathic medicine involved meets the conditions described in subparagraph (A) of section 292s(b)(2) of this title
or the conditions described in subparagraph
(C) of such section.
(B) For purposes of subparagraph (A), the
conditions referred to in such subparagraph
shall be applied with respect to graduates of
the school involved whose date of graduation
occurred approximately 3 years before June 30
of the fiscal year preceding the fiscal year for
which the Federal capital contribution involved is made.
(July 1, 1944, ch. 373, title VII, § 735, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2021; amended Pub. L. 102–531, title III,
§ 313(a)(1), Oct. 27, 1992, 106 Stat. 3507; Pub. L.
103–43, title XX, § 2014(d), June 10, 1993, 107 Stat.
217; Pub. L. 105–392, title I, § 134(c), Nov. 13, 1998,
112 Stat. 3578.)
PRIOR PROVISIONS
A prior section 735 of act July 1, 1944, was classified
to section 294h of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
1998—Subsec. (e)(2). Pub. L. 105–392 reenacted heading
without change and amended text of par. (2) generally.
Prior to amendment, text read as follows: ‘‘Amounts
described in paragraph (1) that are returned to the Secretary before the fourth quarter of a fiscal year shall be
obligated before the end of such fiscal year, and may
not be obligated before the fourth quarter. For purposes of the preceding sentence, amounts returned to
the Secretary during the last quarter of a fiscal year
are deemed to have been returned during the first three
quarters of the succeeding fiscal year.’’
1993—Subsec. (f). Pub. L. 103–43 added subsec. (f).
1992—Subsec. (b). Pub. L. 102–531 inserted designations for cls. (A) and (B) in first sentence.
EFFECTIVE DATE OF 1992 AMENDMENT
Section 313(c) of Pub. L. 102–531 provided that: ‘‘The
amendments described in this section [amending this
section and sections 293j, 293l, 294n, 295j, 295l, 295n, 295o,
296k, and 298b–7 of this title, repealing section 297j of

Page 775

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this title, redesignating subpart IV of part B of subchapter VI of this chapter as subpart III, and amending
provisions set out as a note under section 295k of this
title] are made, and take effect, immediately after the
enactment of the bill, H.R. 3508, of the One Hundred
Second Congress [Pub. L. 102–408, approved Oct. 13,
1992].’’

PART B—HEALTH PROFESSIONS TRAINING FOR
DIVERSITY
§ 293. Centers of excellence
(a) In general
The Secretary shall make grants to, and enter
into contracts with, designated health professions schools described in subsection (c) of this
section, and other public and nonprofit health or
educational entities, for the purpose of assisting
the schools in supporting programs of excellence
in health professions education for under-represented minority individuals.
(b) Required use of funds
The Secretary may not make a grant under
subsection (a) of this section unless the designated health professions school involved
agrees, subject to subsection (c)(1)(C) of this section, to expend the grant—
(1) to develop a large competitive applicant
pool through linkages with institutions of
higher education, local school districts, and
other community-based entities and establish
an education pipeline for health professions
careers;
(2) to establish, strengthen, or expand programs to enhance the academic performance
of under-represented minority students attending the school;
(3) to improve the capacity of such school to
train, recruit, and retain under-represented
minority faculty including the payment of
such stipends and fellowships as the Secretary
may determine appropriate;
(4) to carry out activities to improve the information resources, clinical education, curricula and cultural competence of the graduates of the school, as it relates to minority
health issues;
(5) to facilitate faculty and student research
on health issues particularly affecting underrepresented minority groups, including research on issues relating to the delivery of
health care;
(6) to carry out a program to train students
of the school in providing health services to a
significant number of under-represented minority individuals through training provided
to such students at community-based health
facilities that—
(A) provide such health services; and
(B) are located at a site remote from the
main site of the teaching facilities of the
school; and
(7) to provide stipends as the Secretary determines appropriate, in amounts as the Secretary determines appropriate.
(c) Centers of excellence
(1) Designated schools
(A) In general
The designated health professions schools
referred to in subsection (a) of this section

§ 293

are such schools that meet each of the conditions specified in subparagraphs (B) and
(C), and that—
(i) meet each of the conditions specified
in paragraph (2)(A);
(ii) meet each of the conditions specified
in paragraph (3);
(iii) meet each of the conditions specified in paragraph (4); or
(iv) meet each of the conditions specified
in paragraph (5).
(B) General conditions
The conditions specified in this subparagraph are that a designated health professions school—
(i) has a significant number of under-represented minority individuals enrolled in
the school, including individuals accepted
for enrollment in the school;
(ii) has been effective in assisting underrepresented minority students of the
school to complete the program of education and receive the degree involved;
(iii) has been effective in recruiting
under-represented minority individuals to
enroll in and graduate from the school, including providing scholarships and other
financial assistance to such individuals
and encouraging under-represented minority students from all levels of the educational pipeline to pursue health professions careers; and
(iv) has made significant recruitment efforts to increase the number of under-represented minority individuals serving in
faculty or administrative positions at the
school.
(C) Consortium
The condition specified in this subparagraph is that, in accordance with subsection
(e)(1) of this section, the designated health
profession school involved has with other
health profession schools (designated or
otherwise) formed a consortium to carry out
the purposes described in subsection (b) of
this section at the schools of the consortium.
(D) Application of criteria to other programs
In the case of any criteria established by
the Secretary for purposes of determining
whether schools meet the conditions described in subparagraph (B), this section
may not, with respect to racial and ethnic
minorities, be construed to authorize, require, or prohibit the use of such criteria in
any program other than the program established in this section.
(2) Centers of excellence at certain historically
black colleges and universities
(A) Conditions
The conditions specified in this subparagraph are that a designated health professions school—
(i) is a school described in section 295p(1)
of this title; and
(ii) received a contract under section
295g–8b of this title for fiscal year 1987, as
such section was in effect for such fiscal
year.

§ 293

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Use of grant
In addition to the purposes described in
subsection (b) of this section, a grant under
subsection (a) of this section to a designated
health professions school meeting the conditions described in subparagraph (A) may be
expended—
(i) to develop a plan to achieve institutional improvements, including financial
independence, to enable the school to support programs of excellence in health professions education for under-represented
minority individuals; and
(ii) to provide improved access to the library and informational resources of the
school.
(C) Exception
The requirements of paragraph (1)(C) shall
not apply to a historically black college or
university that receives funding under paragraphs 1 (2) or (5).
(3) Hispanic centers of excellence
The conditions specified in this paragraph
are that—
(A) with respect to Hispanic individuals,
each of clauses (i) through (iv) of paragraph
(1)(B) applies to the designated health professions school involved;
(B) the school agrees, as a condition of receiving a grant under subsection (a) of this
section, that the school will, in carrying out
the duties described in subsection (b) of this
section, give priority to carrying out the duties with respect to Hispanic individuals;
and
(C) the school agrees, as a condition of receiving a grant under subsection (a) of this
section, that—
(i) the school will establish an arrangement with 1 or more public or nonprofit
community based Hispanic serving organizations, or public or nonprofit private institutions of higher education, including
schools of nursing, whose enrollment of
students has traditionally included a significant number of Hispanic individuals,
the purposes of which will be to carry out
a program—
(I) to identify Hispanic students who
are interested in a career in the health
profession involved; and
(II) to facilitate the educational preparation of such students to enter the
health professions school; and
(ii) the school will make efforts to recruit Hispanic students, including students
who have participated in the undergraduate or other matriculation program carried out under arrangements established
by the school pursuant to clause (i)(II) and
will assist Hispanic students regarding the
completion of the educational requirements for a degree from the school.
(4) Native American centers of excellence
Subject to subsection (e) of this section, the
conditions specified in this paragraph are
that—
1 So

in original. Probably should be ‘‘paragraph’’.

Page 776

(A) with respect to Native Americans, each
of clauses (i) through (iv) of paragraph (1)(B)
applies to the designated health professions
school involved;
(B) the school agrees, as a condition of receiving a grant under subsection (a) of this
section, that the school will, in carrying out
the duties described in subsection (b) of this
section, give priority to carrying out the duties with respect to Native Americans; and
(C) the school agrees, as a condition of receiving a grant under subsection (a) of this
section, that—
(i) the school will establish an arrangement with 1 or more public or nonprofit
private institutions of higher education,
including schools of nursing, whose enrollment of students has traditionally included a significant number of Native
Americans, the purpose of which arrangement will be to carry out a program—
(I) to identify Native American students, from the institutions of higher
education referred to in clause (i), who
are interested in health professions careers; and
(II) to facilitate the educational preparation of such students to enter the designated health professions school; and
(ii) the designated health professions
school will make efforts to recruit Native
American students, including students
who have participated in the undergraduate program carried out under arrangements established by the school pursuant
to clause (i) and will assist Native American students regarding the completion of
the educational requirements for a degree
from the designated health professions
school.
(5) Other centers of excellence
The conditions specified in this paragraph
are—
(A) with respect to other centers of excellence, the conditions described in clauses (i)
through (iv) of paragraph (1)(B); and
(B) that the health professions school involved has an enrollment of under-represented minorities above the national average for such enrollments of health professions schools.
(d) Designation as center of excellence
(1) In general
Any designated health professions school receiving a grant under subsection (a) of this
section and meeting the conditions described
in paragraph (2) or (5) of subsection (c) of this
section shall, for purposes of this section, be
designated by the Secretary as a Center of Excellence
in
Under-Represented
Minority
Health Professions Education.
(2) Hispanic centers of excellence
Any designated health professions school receiving a grant under subsection (a) of this
section and meeting the conditions described
in subsection (c)(3) of this section shall, for
purposes of this section, be designated by the
Secretary as a Hispanic Center of Excellence
in Health Professions Education.

Page 777

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Native American centers of excellence
Any designated health professions school receiving a grant under subsection (a) of this
section and meeting the conditions described
in subsection (c)(4) of this section shall, for
purposes of this section, be designated by the
Secretary as a Native American Center of Excellence in Health Professions Education. Any
consortium receiving such a grant pursuant to
subsection (e) of this section shall, for purposes of this section, be so designated.
(e) Authority regarding Native American centers
of excellence
With respect to meeting the conditions specified in subsection (c)(4) of this section, the Secretary may make a grant under subsection (a) of
this section to a designated health professions
school that does not meet such conditions if—
(1) the school has formed a consortium in accordance with subsection (d)(1) of this section;
and
(2) the schools of the consortium collectively
meet such conditions, without regard to
whether the schools individually meet such
conditions.
(f) Duration of grant
The period during which payments are made
under a grant under subsection (a) of this section may not exceed 5 years. Such payments
shall be subject to annual approval by the Secretary and to the availability of appropriations
for the fiscal year involved to make the payments.
(g) Definitions
In this section:
(1) Designated health professions school
(A) In general
The term ‘‘health professions school’’
means, except as provided in subparagraph
(B), a school of medicine, a school of osteopathic medicine, a school of dentistry, a
school of pharmacy, or a graduate program
in behavioral or mental health.
(B) Exception
The definition established in subparagraph
(A) shall not apply to the use of the term
‘‘designated health professions school’’ for
purposes of subsection (c)(2) of this section.
(2) Program of excellence
The term ‘‘program of excellence’’ means
any program carried out by a designated
health professions school with a grant made
under subsection (a) of this section, if the program is for purposes for which the school involved is authorized in subsection (b) or (c) of
this section to expend the grant.
(3) Native Americans
The term ‘‘Native Americans’’ means American Indians, Alaskan Natives, Aleuts, and Native Hawaiians.
(h) Formula for allocations
(1) Allocations
Based on the amount appropriated under
subsection (i) for a fiscal year, the following
subparagraphs shall apply as appropriate:

§ 293

(A) In general
If the amounts appropriated under subsection (i) for a fiscal year are $24,000,000 or
less—
(i) the Secretary shall make available
$12,000,000 for grants under subsection (a)
to health professions schools that meet the
conditions
described
in
subsection
(c)(2)(A); and
(ii) and 2 available after grants are made
with funds under clause (i), the Secretary
shall make available—
(I) 60 percent of such amount for
grants under subsection (a) to health
professions schools that meet the conditions described in paragraph (3) or (4) of
subsection (c) (including meeting the
conditions under subsection (e)); and
(II) 40 percent of such amount for
grants under subsection (a) to health
professions schools that meet the conditions described in subsection (c)(5).
(B) Funding in excess of $24,000,000
If amounts appropriated under subsection
(i) for a fiscal year exceed $24,000,000 but are
less than $30,000,000—
(i) 80 percent of such excess amounts
shall be made available for grants under
subsection (a) to health professions
schools that meet the requirements described in paragraph (3) or (4) of subsection
(c) (including meeting conditions pursuant
to subsection (e)); and
(ii) 20 percent of such excess amount
shall be made available for grants under
subsection (a) to health professions
schools that meet the conditions described
in subsection (c)(5).
(C) Funding in excess of $30,000,000
If amounts appropriated under subsection
(i) for a fiscal year exceed $30,000,000 but are
less than $40,000,000, the Secretary shall
make available—
(i) not less than $12,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in subsection (c)(2)(A);
(ii) not less than $12,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in paragraph (3) or (4) of subsection (c) (including meeting conditions pursuant to
subsection (e));
(iii) not less than $6,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in subsection (c)(5); and
(iv) after grants are made with funds
under clauses (i) through (iii), any remaining excess amount for grants under subsection (a) to health professions schools
that meet the conditions described in
paragraph (2)(A), (3), (4), or (5) of subsection (c).
(D) Funding in excess of $40,000,000
If amounts appropriated under subsection
(i) for a fiscal year are $40,000,000 or more,
the Secretary shall make available—
2 So

in original. The word ‘‘and’’ probably should not appear.

§ 293a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) not less than $16,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in subsection (c)(2)(A);
(ii) not less than $16,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in paragraph (3) or (4) of subsection (c) (including meeting conditions pursuant to
subsection (e));
(iii) not less than $8,000,000 for grants
under subsection (a) to health professions
schools that meet the conditions described
in subsection (c)(5); and
(iv) after grants are made with funds
under clauses (i) through (iii), any remaining funds for grants under subsection (a) to
health professions schools that meet the
conditions described in paragraph (2)(A),
(3), (4), or (5) of subsection (c).
(2) No limitation
Nothing in this subsection shall be construed as limiting the centers of excellence referred to in this section to the designated
amount, or to preclude such entities from
competing for grants under this section.
(3) Maintenance of effort
(A) In general
With respect to activities for which a
grant made under this part are authorized to
be expended, the Secretary may not make
such a grant to a center of excellence for
any fiscal year unless the center agrees to
maintain
expenditures
of
non-Federal
amounts for such activities at a level that is
not less than the level of such expenditures
maintained by the center for the fiscal year
preceding the fiscal year for which the
school receives such a grant.
(B) Use of Federal funds
With respect to any Federal amounts received by a center of excellence and available for carrying out activities for which a
grant under this part is authorized to be expended, the center shall, before expending
the grant, expend the Federal amounts obtained from sources other than the grant,
unless given prior approval from the Secretary.
(i) Authorization of appropriations
There are authorized to be appropriated to
carry out this section—
(1) $50,000,000 for each of the fiscal years 2010
through 2015; and
(2) and 2 such sums as are necessary for each
subsequent fiscal year.
(July 1, 1944, ch. 373, title VII, § 736, as added
Pub. L. 105–392, title I, § 101(a), Nov. 13, 1998, 112
Stat. 3525; amended Pub. L. 111–148, title V,
§ 5401, Mar. 23, 2010, 124 Stat. 642.)
REFERENCES IN TEXT
Section 295g–8b of this title, referred to in subsec.
(c)(2)(A)(ii), was omitted in the general amendment of
this subchapter by Pub. L. 102–408, title I, § 102, Oct. 13,
1992, 106 Stat. 1994.
PRIOR PROVISIONS
A prior section 293, act July 1, 1944, ch. 373, title VII,
§ 736, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,

Page 778

106 Stat. 2022, authorized grants to schools of medicine,
osteopathic medicine, and dentistry for need-based
scholarships, prior to the general amendment of this
part by Pub. L. 105–392.
Another prior section 293, act July 1, 1944, ch. 373,
title VII, § 720, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 164; amended Sept. 4, 1964, Pub. L. 88–581,
§ 3(a), 78 Stat. 919; Oct. 22, 1965, Pub. L. 89–290, § 3(a), 79
Stat. 1056; Nov. 2, 1966, Pub. L. 89–709, § 2(a), 80 Stat.
1103; Aug. 16, 1968, Pub. L. 90–490, title I, § 101(a), (b)(1),
82 Stat. 773; Nov. 18, 1971, Pub. L. 92–157, title I, § 102(a),
85 Stat. 431; Oct. 12, 1976, Pub. L. 94–484, title I, § 101(c),
title III, § 302, 90 Stat. 2244, 2253; Aug. 13, 1981, Pub. L.
97–35, title XXVII, § 2723(a), (b), 95 Stat. 915, authorized
grants for construction of teaching facilities for medical, dental, and other health personnel, prior to the
general revision of this subchapter by Pub. L. 102–408.
A prior section 736 of act July 1, 1944, was classified
to section 294i of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
2010—Subsecs. (h), (i). Pub. L. 111–148 added subsecs.
(h) and (i) and struck out former subsec. (h) which related to authorization of appropriations for fiscal years
1998 through 2002 and allocations of amounts.
SAVINGS PROVISION
Pub. L. 105–392, title I, § 110, Nov. 13, 1998, 112 Stat.
3562, provided that: ‘‘In the case of any authority for
making awards of grants or contracts that is terminated by the amendments made by this subtitle [subtitle A (§§ 101–110) of title I of Pub. L. 105–392, see Tables
for classification], the Secretary of Health and Human
Services may, notwithstanding the termination of the
authority, continue in effect any grant or contract
made under the authority that is in effect on the day
before the date of the enactment of this Act [Nov. 13,
1998], subject to the duration of any such grant or contract not exceeding the period determined by the Secretary in first approving such financial assistance, or
in approving the most recent request made (before the
date of such enactment) for continuation of such assistance, as the case may be.’’

§ 293a. Scholarships for disadvantaged students
(a) In general
The Secretary may make a grant to an eligible entity (as defined in subsection (d)(1) of this
section) under this section for the awarding of
scholarships by schools to any full-time student
who is an eligible individual as defined in subsection (d) of this section. Such scholarships
may be expended only for tuition expenses,
other reasonable educational expenses, and reasonable living expenses incurred in the attendance of such school.
(b) Preference in providing scholarships
The Secretary may not make a grant to an entity under subsection (a) of this section unless
the health professions and nursing schools involved agree that, in providing scholarships pursuant to the grant, the schools will give preference to students for whom the costs of attending the schools would constitute a severe financial hardship and, notwithstanding other provisions of this section, to former recipients of
scholarships under sections 293 and 293d(d)(2)(B)
of this title (as such sections existed on the day
before November 13, 1998).
(c) Amount of award
In awarding grants to eligible entities that are
health professions and nursing schools, the Sec-

Page 779

TITLE 42—THE PUBLIC HEALTH AND WELFARE

retary shall give priority to eligible entities
based on the proportion of graduating students
going into primary care, the proportion of
underrepresented minority students, and the
proportion of graduates working in medically
underserved communities.
(d) Definitions
In this section:
(1) Eligible entities
The term ‘‘eligible entities’’ means an entity
that—
(A) is a school of medicine, osteopathic
medicine, dentistry, nursing (as defined in
section 296 of this title), pharmacy, podiatric
medicine, optometry, veterinary medicine,
public health, chiropractic, or allied health,
a school offering a graduate program in behavioral and mental health practice, or an
entity providing programs for the training
of physician assistants; and
(B) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including students who
are members of racial and ethnic minority
groups.
(2) Eligible individual
The term ‘‘eligible individual’’ means an individual who—
(A) is from a disadvantaged background;
(B) has a financial need for a scholarship;
and
(C) is enrolled (or accepted for enrollment)
at an eligible health professions or nursing
school as a full-time student in a program
leading to a degree in a health profession or
nursing.
(July 1, 1944, ch. 373, title VII, § 737, as added
Pub. L. 105–392, title I, § 101(a), Nov. 13, 1998, 112
Stat. 3531.)
PRIOR PROVISIONS
A prior section 293a, act July 1, 1944, ch. 373, title VII,
§ 737, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2023, authorized grants to health professions
schools for provision of scholarships and undergraduate
assistance, prior to the general amendment of this part
by Pub. L. 105–392.
Another prior section 293a, act July 1, 1944, ch. 373,
title VII, § 721, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 165; amended Sept. 4, 1964, Pub. L. 88–581,
§ 3(b), 78 Stat. 919; Oct. 22, 1965, Pub. L. 89–290, §§ 3(b),
(c), 5(a), 79 Stat. 1056–1058; Nov. 2, 1966, Pub. L. 89–709,
§ 2(b), 80 Stat. 1103; Aug. 16, 1968, Pub. L. 90–490, title I,
§§ 103(a)(3), 105(a), (b), 82 Stat. 774; Nov. 18, 1971, Pub. L.
92–157, title I, §§ 102(e), (f)(1), (2)(A), (g), (h), (j)(2), (3),
(7)(A), 108(b)(1), 85 Stat. 434–437, 461; Oct. 12, 1976, Pub.
L. 94–484, title III, §§ 301, 303, 308(a), 90 Stat. 2253, 2254,
2256; Aug. 1, 1977, Pub. L. 95–83, title III, § 307(b), 91 Stat.
389; Oct. 17, 1979, Pub. L. 96–88, title III, § 301(a)(1), title
V, § 507, 93 Stat. 677, 692; Aug. 13, 1981, Pub. L. 97–35,
title XXVII, §§ 2723(c), (d), 2724(a), 95 Stat. 916; Nov. 4,
1988, Pub. L. 100–607, title VI, §§ 628(4), 629(b)(2), 102 Stat.
3145, 3146; Aug. 16, 1989, Pub. L. 101–93, § 5(o)(1), 103 Stat.
614, related to applications and eligibility for grants for
construction of teaching facilities for medical, dental,
and other health personnel, prior to the general revision of this subchapter by Pub. L. 102–408.
A prior section 737 of act July 1, 1944, was classified
to section 294j of this title prior to the general revision
of this subchapter by Pub. L. 102–408.

§ 293b

§ 293b. Loan repayments and fellowships regarding faculty positions
(a) Loan repayments
(1) Establishment of program
The Secretary shall establish a program of
entering into contracts with individuals described in paragraph (2) under which the individuals agree to serve as members of the faculties of schools described in paragraph (3) in
consideration of the Federal Government
agreeing to pay, for each year of such service,
not more than $30,000 of the principal and interest of the educational loans of such individuals.
(2) Eligible individuals
The individuals referred to in paragraph (1)
are individuals from disadvantaged backgrounds who—
(A) have a degree in medicine, osteopathic
medicine, dentistry, nursing, or another
health profession;
(B) are enrolled in an approved graduate
training program in medicine, osteopathic
medicine, dentistry, nursing, or other health
profession; or
(C) are enrolled as full-time students—
(i) in an accredited (as determined by the
Secretary) school described in paragraph
(3); and
(ii) in the final year of a course of a
study or program, offered by such institution and approved by the Secretary, leading to a degree from such a school.
(3) Eligible health professions schools
The schools described in this paragraph are
schools of medicine, nursing (as schools of
nursing are defined in section 296 of this title),
osteopathic medicine, dentistry, pharmacy, allied health, podiatric medicine, optometry,
veterinary medicine, or public health, schools
offering physician assistant education programs, or schools offering graduate programs
in behavioral and mental health.
(4) Requirements regarding faculty positions
The Secretary may not enter into a contract
under paragraph (1) unless—
(A) the individual involved has entered
into a contract with a school described in
paragraph (3) to serve as a member of the
faculty of the school for not less than 2
years; and
(B) the contract referred to in subparagraph (A) provides that—
(i) the school will, for each year for
which the individual will serve as a member of the faculty under the contract with
the school, make payments of the principal and interest due on the educational
loans of the individual for such year in an
amount equal to the amount of such payments made by the Secretary for the year;
(ii) the payments made by the school
pursuant to clause (i) on behalf of the individual will be in addition to the pay that
the individual would otherwise receive for
serving as a member of such faculty; and
(iii) the school, in making a determination of the amount of compensation to be

§ 293b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

provided by the school to the individual
for serving as a member of the faculty,
will make the determination without regard to the amount of payments made (or
to be made) to the individual by the Federal Government under paragraph (1).
(5) Applicability of certain provisions
The provisions of sections 254m, 254p, and
254q–1 of this title shall apply to the program
established in paragraph (1) to the same extent and in the same manner as such provisions apply to the National Health Service
Corps Loan Repayment Program established
in subpart III of part D of subchapter II of this
chapter, including the applicability of provisions regarding reimbursements for increased
tax liability and regarding bankruptcy.
(6) Waiver regarding school contributions
The Secretary may waive the requirement
established in paragraph (4)(B) if the Secretary determines that the requirement will
impose an undue financial hardship on the
school involved.
(b) Fellowships
(1) In general
The Secretary may make grants to and
enter into contracts with eligible entities to
assist such entities in increasing the number
of underrepresented minority individuals who
are members of the faculty of such schools.
(2) Applications
To be eligible to receive a grant or contract
under this subsection, an entity shall provide
an assurance, in the application submitted by
the entity, that—
(A) amounts received under such a grant
or contract will be used to award a fellowship to an individual only if the individual
meets the requirements of paragraphs (3)
and (4); and
(B) each fellowship awarded pursuant to
the grant or contract will include—
(i) a stipend in an amount not exceeding
50 percent of the regular salary of a similar faculty member for not to exceed 3
years of training; and
(ii) an allowance for other expenses, such
as travel to professional meetings and
costs related to specialized training.
(3) Eligibility
To be eligible to receive a grant or contract
under paragraph (1), an applicant shall demonstrate to the Secretary that such applicant
has or will have the ability to—
(A) identify, recruit and select underrepresented minority individuals who have
the potential for teaching, administration,
or conducting research at a health professions institution;
(B) provide such individuals with the skills
necessary to enable them to secure a tenured faculty position at such institution,
which may include training with respect to
pedagogical skills, program administration,
the design and conduct of research, grants
writing, and the preparation of articles suitable for publication in peer reviewed journals;

Page 780

(C) provide services designed to assist such
individuals in their preparation for an academic career, including the provision of
counselors; and
(D) provide health services to rural or
medically underserved populations.
(4) Requirements
To be eligible to receive a grant or contract
under paragraph (1) an applicant shall—
(A) provide an assurance that such applicant will make available (directly through
cash donations) $1 for every $1 of Federal
funds received under this section for the fellowship;
(B) provide an assurance that institutional
support will be provided for the individual
for the second and third years at a level that
is equal to the total amount of institutional
funds provided in the year in which the
grant or contract was awarded;
(C) provide an assurance that the individual that will receive the fellowship will be a
member of the faculty of the applicant
school; and
(D) provide an assurance that the individual that will receive the fellowship will
have, at a minimum, appropriate advanced
preparation (such as a master’s or doctoral
degree) and special skills necessary to enable such individual to teach and practice.
(5) Definition
For purposes of this subsection, the term
‘‘underrepresented
minority
individuals’’
means individuals who are members of racial
or ethnic minority groups that are underrepresented in the health professions including
nursing.
(July 1, 1944, ch. 373, title VII, § 738, as added
Pub. L. 105–392, title I, § 101(a), Nov. 13, 1998, 112
Stat. 3532; amended Pub. L. 111–148, title V,
§ 5402(a), title X, § 10501(d), Mar. 23, 2010, 124 Stat.
644, 995.)
REFERENCES IN TEXT
Subpart III of part D of subchapter II of this chapter,
referred to in subsec. (a)(5), is classified to section 254l
et seq. of this title.
PRIOR PROVISIONS
A prior section 293b, act July 1, 1944, ch. 373, title VII,
§ 738, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2025, related to loan repayments and fellowships regarding faculty positions, prior to the general
amendment of this part by Pub. L. 105–392.
Another prior section 293b, act July 1, 1944, ch. 373,
title VII, § 722, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 168; amended Aug. 16, 1968, Pub. L. 90–490,
title I, §§ 102(a), 104(a), 82 Stat. 773, 774; Nov. 18, 1971,
Pub. L. 92–157, title I, § 102(b), (j)(4), (7), 85 Stat. 431, 436,
437; Oct. 12, 1976, Pub. L. 94–484, title III, § 304, 90 Stat.
2255; Aug. 13, 1981, Pub. L. 97–35, title XXVII, § 2723(e),
95 Stat. 916, related to amounts of grants and grants for
multipurpose facilities, prior to the general revision of
this subchapter by Pub. L. 102–408.
A prior section 738 of act July 1, 1944, was classified
to section 294k of this title prior to the general revision
of this subchapter by Pub. L. 102–408.
AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–148, § 5402(a), substituted ‘‘$30,000’’ for ‘‘$20,000’’.
Subsec. (a)(3). Pub. L. 111–148, § 10501(d), inserted
‘‘schools offering physician assistant education programs,’’ after ‘‘public health,’’.

Page 781

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 293c

§ 293c. Educational assistance in the health professions regarding individuals from disadvantaged backgrounds

through partnerships with institutions of
higher education, school districts, and other
community-based entities.

(a) In general
(1) Authority for grants
For the purpose of assisting individuals from
disadvantaged backgrounds, as determined in
accordance with criteria prescribed by the
Secretary, to undertake education to enter a
health profession, the Secretary may make
grants to and enter into contracts with
schools of medicine, osteopathic medicine,
public health, dentistry, veterinary medicine,
optometry, pharmacy, allied health, chiropractic, and podiatric medicine, public and
nonprofit private schools that offer graduate
programs in behavioral and mental health,
programs for the training of physician assistants, and other public or private nonprofit
health or educational entities to assist in
meeting the costs described in paragraph (2).
(2) Authorized expenditures
A grant or contract under paragraph (1) may
be used by the entity to meet the cost of—
(A) identifying, recruiting, and selecting
individuals
from
disadvantaged
backgrounds, as so determined, for education and
training in a health profession;
(B) facilitating the entry of such individuals into such a school;
(C) providing counseling, mentoring, or
other services designed to assist such individuals to complete successfully their education at such a school;
(D) providing, for a period prior to the
entry of such individuals into the regular
course of education of such a school, preliminary education and health research
training designed to assist them to complete
successfully such regular course of education at such a school, or referring such individuals to institutions providing such preliminary education;
(E) publicizing existing sources of financial aid available to students in the education program of such a school or who are
undertaking training necessary to qualify
them to enroll in such a program;
(F) paying such scholarships as the Secretary may determine for such individuals
for any period of health professions education at a health professions school;
(G) paying such stipends as the Secretary
may approve for such individuals for any period of education in student-enhancement
programs (other than regular courses), except that such a stipend may not be provided
to an individual for more than 12 months,
and such a stipend shall be in an amount determined appropriate by the Secretary (notwithstanding any other provision of law regarding the amount of stipends);
(H) carrying out programs under which
such individuals gain experience regarding a
career in a field of primary health care
through working at facilities of public or
private nonprofit community-based providers of primary health services; and
(I) conducting activities to develop a larger and more competitive applicant pool

(3) Definition
In this section, the term ‘‘regular course of
education of such a school’’ as used in subparagraph (D) includes a graduate program in
behavioral or mental health.
(b) Requirements for awards
In making awards to eligible entities under
subsection (a)(1) of this section, the Secretary
shall give preference to approved applications
for programs that involve a comprehensive approach by several public or nonprofit private
health or educational entities to establish, enhance and expand educational programs that
will result in the development of a competitive
applicant pool of individuals from disadvantaged
backgrounds who desire to pursue health professions careers. In considering awards for such a
comprehensive partnership approach, the following shall apply with respect to the entity involved:
(1) The entity shall have a demonstrated
commitment to such approach through formal
agreements that have common objectives with
institutions of higher education, school districts, and other community-based entities.
(2) Such formal agreements shall reflect the
coordination of educational activities and support services, increased linkages, and the consolidation of resources within a specific geographic area.
(3) The design of the educational activities
involved shall provide for the establishment of
a competitive health professions applicant
pool of individuals from disadvantaged backgrounds by enhancing the total preparation
(academic and social) of such individuals to
pursue a health professions career.
(4) The programs or activities under the
award shall focus on developing a culturally
competent health care workforce that will
serve the unserved and underserved populations within the geographic area.
(c) Equitable allocation of financial assistance
The Secretary, to the extent practicable, shall
ensure that services and activities under subsection (a) of this section are adequately allocated among the various racial and ethnic populations who are from disadvantaged backgrounds.
(d) Matching requirements
The Secretary may require that an entity that
applies for a grant or contract under subsection
(a) of this section, provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of the entity to the projects
funded under the grant or contract. As determined by the Secretary, such non-Federal
matching funds may be provided directly or
through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
(July 1, 1944, ch. 373, title VII, § 739, as added
Pub. L. 105–392, title I, § 101(a), Nov. 13, 1998, 112
Stat. 3534.)

§ 293d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 782

PRIOR PROVISIONS

PRIOR PROVISIONS

A prior section 293c, act July 1, 1944, ch. 373, title VII,
§ 739, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2027, related to centers of excellence in health
professions education for minority individuals, prior to
the general amendment of this part by Pub. L. 105–392.
See section 293 of this title.
Another prior section 293c, act July 1, 1944, ch. 373,
title VII, § 723, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 168; amended Aug. 16, 1968, Pub. L. 90–490,
title I, § 103(a)(1), (2), 82 Stat. 773; Nov. 18, 1971, Pub. L.
92–157,title I, § 102(c)(5), (f)(2)(C), (j)(1), (5), 85 Stat. 432,
435–437; Oct. 12, 1976, Pub. L. 94–484, title III, § 305, 90
Stat. 2255; Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2723(f), 95 Stat. 916; Oct. 22, 1985, Pub. L. 99–129, title
II, § 207(a), 99 Stat. 527, related to recovery by United
States of grant moneys where facility was no longer
owned by a public or nonprofit agency or where it
ceased to be used for teaching or training purposes,
prior to the general revision of this subchapter by Pub.
L. 102–408.
A prior section 739 of act July 1, 1944, was classified
to section 294l of this title prior to the general revision
of this subchapter by Pub. L. 102–408.

A prior section 293d, act July 1, 1944, ch. 373, title VII,
§ 740, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2032, related to educational assistance regarding undergraduates, prior to the general amendment of
this part by Pub. L. 105–392.
Another prior section 293d, act July 1, 1944, ch. 373,
title VII, § 724, formerly § 727, as added Sept. 24, 1963,
Pub. L. 88–129, § 2(b), 77 Stat. 170; amended Nov. 18, 1971,
Pub. L. 92–157, title I, § 102(j)(7)(B), 85 Stat. 437; renumbered § 724 and amended Oct. 12, 1976, Pub. L. 94–484,
title III, § 308(c), (d), 90 Stat. 2257, related to promulgation of regulations by Secretary, prior to the general
revision of this subchapter by Pub. L. 102–408.
Another prior section 293d, act July 1, 1944, ch. 373,
title VII, § 701, formerly § 724, as added Sept. 24, 1963,
Pub. L. 88–129, § 2(b), 77 Stat. 169; amended Oct. 22, 1965,
Pub. L. 89–290, § 2(b), 79 Stat. 1056; Nov. 2, 1966, Pub. L.
89–709, § 2(c), 80 Stat. 1103; Aug. 16, 1968, Pub. L. 90–490,
title I, § 105(c), 82 Stat. 774; Nov. 18, 1971, Pub. L. 92–157,
title I, § 102(c)(1)–(4), (f)(2)(B), 85 Stat. 431, 432, 435,
which related to definitions, was renumbered § 701 of
act July 1, 1944, by Pub. L. 94–484 and transferred to
section 292a of this title.
A prior section 740 of act July 1, 1944, was classified
to section 294m of this title prior to the general revision of this subchapter by Pub. L. 102–408.

§ 293d. Authorization of appropriation
(a) Scholarships
There are authorized to be appropriated to
carry out section 293a of this title, $51,000,000 for
fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through
2014. Of the amount appropriated in any fiscal
year, the Secretary shall ensure that not less
than 16 percent shall be distributed to schools of
nursing.
(b) Loan repayments and fellowships
For the purpose of carrying out section 293b of
this title, there is authorized to be appropriated,
$5,000,000 for each of the fiscal years 2010
through 2014.
(c) Educational assistance in health professions
regarding individuals from disadvantaged
backgrounds
For the purpose of grants and contracts under
section 293c(a)(1) of this title, there is authorized to be appropriated $60,000,000 for fiscal year
2010 and such sums as may be necessary for each
of the fiscal years 2011 through 2014. The Secretary may use not to exceed 20 percent of the
amount appropriated for a fiscal year under this
subsection to provide scholarships under section
293c(a)(2)(F) of this title.
(d) Report
Not later than 6 months after November 13,
1998, the Secretary shall prepare and submit to
the appropriate committees of Congress a report
concerning the efforts of the Secretary to address the need for a representative mix of individuals from historically minority health professions schools, or from institutions or other
entities that historically or by geographic location have a demonstrated record of training or
educating underrepresented minorities, within
various health professions disciplines, on peer
review councils.
(July 1, 1944, ch. 373, title VII, § 740, as added
Pub. L. 105–392, title I, § 101(a), Nov. 13, 1998, 112
Stat. 3536; amended Pub. L. 111–148, title V,
§ 5402(b)–(d), Mar. 23, 2010, 124 Stat. 644.)

AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5402(b), substituted
‘‘$51,000,000 for fiscal year 2010, and such sums as may
be necessary for each of the fiscal years 2011 through
2014’’ for ‘‘$37,000,000 for fiscal year 1998, and such sums
as may be necessary for each of the fiscal years 1999
through 2002’’.
Subsec. (b). Pub. L. 111–148, § 5402(c), substituted ‘‘appropriated, $5,000,000 for each of the fiscal years 2010
through 2014’’ for ‘‘appropriated $1,100,000 for fiscal year
1998, and such sums as may be necessary for each of the
fiscal years 1999 through 2002’’.
Subsec. (c). Pub. L. 111–148, § 5402(d), substituted ‘‘For
the purpose of grants and contracts under section
293c(a)(1) of this title, there is authorized to be appropriated $60,000,000 for fiscal year 2010 and such sums as
may be necessary for each of the fiscal years 2011
through 2014’’ for ‘‘For the purpose of grants and contracts under section 293c(a)(1) of this title, there is authorized to be appropriated $29,400,000 for fiscal year
1998, and such sums as may be necessary for each of the
fiscal years 1999 through 2002’’.

§ 293e. Grants for health professions education
(a) Cultural competency, prevention, and public
health and individuals with disability grants
(1) In general
The Secretary, acting through the Administrator of the Health Resources and Services
Administration, may make awards of grants,
contracts, or cooperative agreements to public
and nonprofit private entities (including tribal
entities) for the development, evaluation, and
dissemination of research, demonstration
projects, and model curricula for cultural
competency, prevention, public health proficiency, reducing health disparities, and aptitude for working with individuals with disabilities training for use in health professions
schools and continuing education programs,
and for other purposes determined as appropriate by the Secretary.
(2) Eligible entities
Unless specifically required otherwise in this
subchapter, the Secretary shall accept applications for grants or contracts under this sec-

Page 783

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion from health professions schools, academic
health centers, State or local governments, or
other appropriate public or private nonprofit
entities (or consortia of entities, including entities
promoting
multidisciplinary
approaches) for funding and participation in
health professions training activities. The
Secretary may accept applications from forprofit private entities as determined appropriate by the Secretary.
(b) Collaboration
In carrying out subsection (a), the Secretary
shall collaborate with health professional societies, licensing and accreditation entities,
health professions schools, and experts in minority health and cultural competency, prevention,
and public health and disability groups, community-based organizations, and other organizations as determined appropriate by the Secretary. The Secretary shall coordinate with curricula and research and demonstration projects
developed under section 296e–1 of this title.
(c) Dissemination
(1) In general
Model curricula developed under this section
shall be disseminated through the Internet
Clearinghouse under section 270 1 and such
other means as determined appropriate by the
Secretary.
(2) Evaluation
The Secretary shall evaluate the adoption
and the implementation of cultural competency, prevention, and public health, and
working with individuals with a disability
training curricula, and the facilitate 2 inclusion of these competency measures in quality
measurement systems as appropriate.
(d) Authorization of appropriations
There is authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2015.
(July 1, 1944, ch. 373, title VII, § 741, as added
Pub. L. 106–525, title IV, § 401(a), Nov. 22, 2000, 114
Stat. 2508; amended Pub. L. 111–148, title V,
§ 5307(a), Mar. 23, 2010, 124 Stat. 628.)
PRIOR PROVISIONS
A prior section 293e, act July 1, 1944, ch. 373, title VII,
§ 725, formerly § 728, as added Sept. 24, 1963, Pub. L.
88–129, § 2(b), 77 Stat. 170; amended Sept. 4, 1964, Pub. L.
88–581, § 3(d), 78 Stat. 919; Nov. 18, 1971, Pub. L. 92–157,
title I, § 102(i), 85 Stat. 436; renumbered § 725, Oct. 12,
1976, Pub. L. 94–484, title III, § 308(d), 90 Stat. 2257, related to technical assistance to applicants for grants for
construction of teaching facilities for medical, dental,
and other health personnel, and to States or interstate
planning agencies to plan programs for relieving shortages of training of health personnel, prior to the general amendment of this subchapter by Pub. L. 102–408,
title I, § 102, Oct. 13, 1992, 106 Stat. 1994.
Another prior section 293e, act July 1, 1944, ch. 373,
title VII, § 702, formerly § 725, as added Sept. 24, 1963,
Pub. L. 88–129, § 2(b), 77 Stat. 169; amended Sept. 4, 1964,
Pub. L. 88–581, § 3(c), 78 Stat. 919; Nov. 2, 1966, Pub. L.
89–709, § 2(d), 80 Stat. 1103; Nov. 3, 1966, Pub. L. 89–751,
§ 3(a), 80 Stat. 1230; Dec. 5, 1967, Pub. L. 90–174, § 12(c), 81
Stat. 541; Oct. 30, 1970, Pub. L. 91–515, title VI,
1 So
2 So

in original. Act July 1, 1944, does not contain a section 270.
in original.

§ 293e

§ 601(b)(2), 84 Stat. 1311; Nov. 18, 1971, Pub. L. 92–157,
title I, § 108(a), 85 Stat. 460, was renumbered § 702 of act
July 1, 1944, by Pub. L. 94–484 and transferred to section
292b of this title, and subsequently omitted in the general amendment of this subchapter by Pub. L. 102–408.
A prior section 293f, act July 1, 1944, ch. 373, title VII,
§ 726, formerly § 729, as added Nov. 18, 1971, Pub. L.
92–157, title I, § 102(d), 85 Stat. 432; renumbered § 726 and
amended Oct. 12, 1976, Pub. L. 94–484, title I, § 101(d),
title III, §§ 306, 308(d), 90 Stat. 2244, 2256, 2257; Aug. 13,
1981, Pub. L. 97–35, title XXVII, § 2725, 95 Stat. 916, related to loan guarantees and interest subsidies, prior to
the general amendment of this subchapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994.
Another prior section 293f, act July 1, 1944, ch. 373,
title VII, § 726, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 170, provided for noninterference with administration of institutions, prior to repeal by Pub. L.
94–484, title III, § 308(b), Oct. 12, 1976, 90 Stat. 2257.
A prior section 293g, act July 1, 1944, ch. 373, title VII,
§ 727, as added Sept. 24, 1963, Pub. L. 88–129, § 2(b), 77
Stat. 170; amended Nov. 18, 1971, Pub. L. 92–157, title I,
§ 102(j)(7)(B), 85 Stat. 437, which related to regulations,
was renumbered section 724 of act July 1, 1944, by Pub.
L. 94–484 and transferred to section 293d of this title,
and subsequently omitted in the general amendment of
this subchapter by Pub. L. 102–408.
A prior section 293h, act July 1, 1944, ch. 373, title VII,
§ 728, as added Sept. 24, 1963, Pub. L. 88–129, § 2(b), 77
Stat. 170; amended Sept. 4, 1964, Pub. L. 88–581, § 3(d), 78
Stat. 919; Nov. 18, 1971, Pub. L. 92–157, title I, § 102(i), 85
Stat. 436, which related to technical assistance, was renumbered section 726 of act July 1, 1944, by Pub. L.
94–484 and transferred to section 293e of this title, and
subsequently omitted in the general amendment of this
subchapter by Pub. L. 102–408.
A prior section 293i, act July 1, 1944, ch. 373, title VII,
§ 729, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 102(d), 85 Stat. 432, which related to loan guarantees
and interest subsidies, was renumbered section 726 of
act July 1, 1944, by Pub. L. 94–484 and transferred to
section 293f of this title, and subsequently omitted in
the general amendment of this subchapter by Pub. L.
102–408.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5307(a)(1)(A), substituted ‘‘Cultural competency, prevention, and public
health and individuals with disability grants’’ for
‘‘Grants for health professions education in health disparities and cultural competency’’ in heading.
Subsec. (a)(1). Pub. L. 111–148, § 5307(a)(1)(B), substituted ‘‘for the development, evaluation, and dissemination of research, demonstration projects, and model
curricula for cultural competency, prevention, public
health proficiency, reducing health disparities, and aptitude for working with individuals with disabilities
training for use in health professions schools and continuing education programs, and for other purposes determined as appropriate by the Secretary’’ for ‘‘for the
purpose of carrying out research and demonstration
projects (including research and demonstration
projects for continuing health professions education)
for training and education of health professionals for
the reduction of disparities in health care outcomes
and the provision of culturally competent health care’’.
Subsecs. (b) to (d). Pub. L. 111–148, § 5307(a)(2), added
subsecs. (b) to (d) and struck out former subsec. (b).
Prior to amendment, text of subsec. (b) read as follows:
‘‘There are authorized to be appropriated to carry out
subsection (a) of this section, $3,500,000 for fiscal year
2001, $7,000,000 for fiscal year 2002, $7,000,000 for fiscal
year 2003, and $3,500,000 for fiscal year 2004.’’
NATIONAL CONFERENCE ON HEALTH PROFESSIONS
EDUCATION AND HEALTH DISPARITIES
Pub. L. 106–525, title IV, § 402, Nov. 22, 2000, 114 Stat.
2509, provided that:
‘‘(a) IN GENERAL.—Not later than 1 year after the
date of enactment of this Act [Nov. 22, 2000], the Sec-

§ 293j

TITLE 42—THE PUBLIC HEALTH AND WELFARE

retary of Health and Human Services (in this section
referred to as the ‘Secretary’), acting through the Administrator of the Health Resources and Services Administration, shall convene a national conference on
health professions education as a method for reducing
disparities in health outcomes.
‘‘(b) PARTICIPANTS.—The Secretary shall include in
the national conference convened under subsection (a)
advocacy groups and educational entities as described
in section 741 of the Public Health Service Act [this
section] (as added by section 401), tribal health programs, health centers under section 330 of such Act
[section 254b of this title], and other interested parties.
‘‘(c) ISSUES.—The national conference convened under
subsection (a) shall include, but is not limited to, issues that address the role and impact of health professions education on the reduction of disparities in
health outcomes, including the role of education on
cultural competency. The conference shall focus on
methods to achieve reductions in disparities in health
outcomes through health professions education (including continuing education programs) and strategies for
outcomes measurement to assess the effectiveness of
education in reducing disparities.
‘‘(d) PUBLICATION OF FINDINGS.—Not later than 6
months after the national conference under subsection
(a) has convened, the Secretary shall publish in the
Federal Register a summary of the proceedings and
findings of the conference.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to carry out this section.’’

PART C—TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL PEDIATRICS, PHYSICIAN ASSISTANTS, GENERAL DENTISTRY, AND PEDIATRIC DENTISTRY
SUBPART 1—MEDICAL TRAINING GENERALLY

§ 293j. Repealed. Pub. L. 105–392, title I, § 102(2),
Nov. 13, 1998, 112 Stat. 3537
Section, act July 1, 1944, ch. 373, title VII, § 746, as
added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106 Stat.
2034; amended Pub. L. 102–531, title III, § 313(a)(2), Oct.
27, 1992, 106 Stat. 3507; Pub. L. 103–43, title XX,
§ 2008(i)(3), June 10, 1993, 107 Stat. 213, related to area
health education center programs.
A prior section 746 of act July 1, 1944, was classified
to section 294q–2 of this title prior to the general revision of this subchapter by Pub. L. 102–408.

§ 293k. Primary care training and enhancement
(a) Support and development of primary care
training programs
(1) In general
The Secretary may make grants to, or enter
into contracts with, an accredited public or
nonprofit private hospital, school of medicine
or osteopathic medicine, academically affiliated physician assistant training program, or
a public or private nonprofit entity which the
Secretary has determined is capable of carrying out such grant or contract—
(A) to plan, develop, operate, or participate in an accredited professional training
program, including an accredited residency
or internship program in the field of family
medicine, general internal medicine, or general pediatrics for medical students, interns,
residents, or practicing physicians as defined
by the Secretary;
(B) to provide need-based financial assistance in the form of traineeships and fellowships to medical students, interns, residents,

Page 784

practicing physicians, or other medical personnel, who are participants in any such program, and who plan to specialize or work in
the practice of the fields defined in subparagraph (A);
(C) to plan, develop, and operate a program
for the training of physicians who plan to
teach in family medicine, general internal
medicine, or general pediatrics training programs;
(D) to plan, develop, and operate a program for the training of physicians teaching
in community-based settings;
(E) to provide financial assistance in the
form of traineeships and fellowships to physicians who are participants in any such programs and who plan to teach or conduct research in a family medicine, general internal
medicine, or general pediatrics training program;
(F) to plan, develop, and operate a physician assistant education program, and for
the training of individuals who will teach in
programs to provide such training;
(G) to plan, develop, and operate a demonstration program that provides training in
new competencies, as recommended by the
Advisory Committee on Training in Primary
Care Medicine and Dentistry and the National Health Care Workforce Commission
established in section 294q of this title,
which may include—
(i) providing training to primary care
physicians relevant to providing care
through patient-centered medical homes
(as defined by the Secretary for purposes
of this section);
(ii) developing tools and curricula relevant to patient-centered medical homes;
and
(iii) providing continuing education to
primary care physicians relevant to patient-centered medical homes; and
(H) to plan, develop, and operate joint degree programs to provide interdisciplinary
and interprofessional graduate training in
public health and other health professions to
provide training in environmental health,
infectious disease control, disease prevention and health promotion, epidemiological
studies and injury control.
(2) Duration of awards
The period during which payments are made
to an entity from an award of a grant or contract under this subsection shall be 5 years.
(b) Capacity building in primary care
(1) In general
The Secretary may make grants to or enter
into contracts with accredited schools of medicine or osteopathic medicine to establish,
maintain, or improve—
(A) academic units or programs that improve clinical teaching and research in fields
defined in subsection (a)(1)(A); or
(B) programs that integrate academic administrative units in fields defined in subsection (a)(1)(A) to enhance interdisciplinary
recruitment, training, and faculty development.

Page 785

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Preference in making awards under this
subsection
In making awards of grants and contracts
under paragraph (1), the Secretary shall give
preference to any qualified applicant for such
an award that agrees to expend the award for
the purpose of—
(A) establishing academic units or programs in fields defined in subsection
(a)(1)(A); or
(B) substantially expanding such units or
programs.
(3) Priorities in making awards
In awarding grants or contracts under paragraph (1), the Secretary shall give priority to
qualified applicants that—
(A) proposes 1 a collaborative project between academic administrative units of primary care;
(B) proposes 1 innovative approaches to
clinical teaching using models of primary
care, such as the patient centered medical
home, team management of chronic disease,
and interprofessional integrated models of
health care that incorporate transitions in
health care settings and integration physical and mental health provision;
(C) have a record of training the greatest
percentage of providers, or that have demonstrated significant improvements in the
percentage of providers trained, who enter
and remain in primary care practice;
(D) have a record of training individuals
who are from underrepresented minority
groups or from a rural or disadvantaged
background;
(E) provide training in the care of vulnerable populations such as children, older
adults, homeless individuals, victims of
abuse or trauma, individuals with mental
health or substance-related disorders, individuals with HIV/AIDS, and individuals with
disabilities;
(F) establish formal relationships and submit joint applications with federally qualified health centers, rural health clinics, area
health education centers, or clinics located
in underserved areas or that serve underserved populations;
(G) teach trainees the skills to provide
interprofessional, integrated care through
collaboration among health professionals;
(H) provide training in enhanced communication with patients, evidence-based practice, chronic disease management, preventive care, health information technology, or
other competencies as recommended by the
Advisory Committee on Training in Primary
Care Medicine and Dentistry and the National Health Care Workforce Commission
established in section 294q of this title; or
(I) provide training in cultural competency
and health literacy.
(4) Duration of awards
The period during which payments are made
to an entity from an award of a grant or contract under this subsection shall be 5 years.
1 So

in original. Probably should be ‘‘propose’’.

§ 293k–1

(c) Authorization of appropriations
(1) In general
For purposes of carrying out this section
(other than subsection (b)(1)(B)), there are authorized to be appropriated $125,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through
2014.
(2) Training programs
Fifteen percent of the amount appropriated
pursuant to paragraph (1) in each such fiscal
year shall be allocated to the physician assistant training programs described in subsection
(a)(1)(F), which prepare students for practice
in primary care.
(3) Integrating academic administrative units
For purposes of carrying out subsection
(b)(1)(B), there are authorized to be appropriated $750,000 for each of fiscal years 2010
through 2014.
(July 1, 1944, ch. 373, title VII, § 747, as added
Pub. L. 111–148, title V, § 5301, Mar. 23, 2010, 124
Stat. 615.)
CODIFICATION
Pub. L. 111–148, title V, § 5301, Mar. 23, 2010, 124 Stat.
615, which directed the amendment of part C of title VII
by striking out section 747 and inserting a new section
747, without specifying the act to be amended, was executed as an amendment to part C of title VII of act
July 1, 1944, by adding this section and repealing
former section 293k of this title, to reflect the probable
intent of Congress.
PRIOR PROVISIONS
A prior section 293k, act July 1, 1944, ch. 373, title VII,
§ 747, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2042; amended Pub. L. 105–392, title I, § 102(3),
Nov. 13, 1998, 112 Stat. 3537, related to grants and contracts for training in family medicine, general internal
medicine, general pediatrics, general dentistry, and pediatric dentistry, and training for physician assistants,
prior to repeal by Pub. L. 111–148, title V, § 5301, Mar. 23,
2010, 124 Stat. 615. See Codification note above.
A prior section 747 of act July 1, 1944, was classified
to section 294q–3 of this title prior to the general revision of this subchapter by Pub. L. 102–408.
Another prior section 747 of act July 1, 1944, was classified to section 294g of this title prior to repeal by
Pub. L. 94–484.

§ 293k–1. Training opportunities for direct care
workers
(a) In general
The Secretary shall award grants to eligible
entities to enable such entities to provide new
training opportunities for direct care workers
who are employed in long-term care settings
such as nursing homes (as defined in section
1396g(e)(1) of this title), assisted living facilities
and skilled nursing facilities, intermediate care
facilities for individuals with mental retardation, home and community based settings, and
any other setting the Secretary determines to
be appropriate.
(b) Eligibility
To be eligible to receive a grant under this
section, an entity shall—
(1) be an institution of higher education (as
defined in section 1002 of title 20) that—

§ 293k–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) is accredited by a nationally recognized accrediting agency or association listed under section 1001(c) of title 20; and
(B) has established a public-private educational partnership with a nursing home or
skilled nursing facility, agency or entity
providing home and community based services to individuals with disabilities, or other
long-term care provider; and
(2) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require.
(c) Use of funds
An eligible entity shall use amounts awarded
under a grant under this section to provide assistance to eligible individuals to offset the cost
of tuition and required fees for enrollment in
academic programs provided by such entity.
(d) Eligible individual
(1) Eligibility
To be eligible for assistance under this section, an individual shall be enrolled in courses
provided by a grantee under this subsection
and maintain satisfactory academic progress
in such courses.
(2) Condition of assistance
As a condition of receiving assistance under
this section, an individual shall agree that,
following completion of the assistance period,
the individual will work in the field of geriatrics, disability services, long term services
and supports, or chronic care management for
a minimum of 2 years under guidelines set by
the Secretary.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $10,000,000 for the period
of fiscal years 2011 through 2013.
(July 1, 1944, ch. 373, title VII, § 747A, as added
Pub. L. 111–148, title V, § 5302, Mar. 23, 2010, 124
Stat. 617.)
§ 293k–2. Training in general, pediatric, and public health dentistry
(a) Support and development of dental training
programs
(1) In general
The Secretary may make grants to, or enter
into contracts with, a school of dentistry, public or nonprofit private hospital, or a public or
private nonprofit entity which the Secretary
has determined is capable of carrying out such
grant or contract—
(A) to plan, develop, and operate, or participate in, an approved professional training program in the field of general dentistry,
pediatric dentistry, or public health dentistry for dental students, residents, practicing dentists, dental hygienists, or other approved primary care dental trainees, that
emphasizes training for general, pediatric,
or public health dentistry;
(B) to provide financial assistance to dental students, residents, practicing dentists,
and dental hygiene students who are in need

Page 786

thereof, who are participants in any such
program, and who plan to work in the practice of general, pediatric, public heath dentistry, or dental hygiene;
(C) to plan, develop, and operate a program
for the training of oral health care providers
who plan to teach in general, pediatric, public health dentistry, or dental hygiene;
(D) to provide financial assistance in the
form of traineeships and fellowships to dentists who plan to teach or are teaching in
general, pediatric, or public health dentistry;
(E) to meet the costs of projects to establish, maintain, or improve dental faculty development programs in primary care (which
may be departments, divisions or other
units);
(F) to meet the costs of projects to establish, maintain, or improve predoctoral and
postdoctoral training in primary care programs;
(G) to create a loan repayment program
for faculty in dental programs; and
(H) to provide technical assistance to pediatric training programs in developing and
implementing instruction regarding the oral
health status, dental care needs, and riskbased clinical disease management of all pediatric populations with an emphasis on underserved children.
(2) Faculty loan repayment
(A) In general
A grant or contract under subsection
(a)(1)(G) may be awarded to a program of
general, pediatric, or public health dentistry
described in such subsection to plan, develop, and operate a loan repayment program under which—
(i) individuals agree to serve full-time as
faculty members; and
(ii) the program of general, pediatric or
public health dentistry agrees to pay the
principal and interest on the outstanding
student loans of the individuals.
(B) Manner of payments
With respect to the payments described in
subparagraph (A)(ii), upon completion by an
individual of each of the first, second, third,
fourth, and fifth years of service, the program shall pay an amount equal to 10, 15, 20,
25, and 30 percent, respectively, of the individual’s student loan balance as calculated
based on principal and interest owed at the
initiation of the agreement.
(b) Eligible entity
For purposes of this subsection, entities eligible for such grants or contracts in general, pediatric, or public health dentistry shall include
entities that have programs in dental or dental
hygiene schools, or approved residency or advanced education programs in the practice of
general, pediatric, or public health dentistry.
Eligible entities may partner with schools of
public health to permit the education of dental
students, residents, and dental hygiene students
for a master’s year in public health at a school
of public health.

Page 787

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Priorities in making awards
With respect to training provided for under
this section, the Secretary shall give priority in
awarding grants or contracts to the following:
(1) Qualified applicants that propose collaborative projects between departments of primary care medicine and departments of general, pediatric, or public health dentistry.
(2) Qualified applicants that have a record of
training the greatest percentage of providers,
or that have demonstrated significant improvements in the percentage of providers,
who enter and remain in general, pediatric, or
public health dentistry.
(3) Qualified applicants that have a record of
training individuals who are from a rural or
disadvantaged background, or from underrepresented minorities.
(4) Qualified applicants that establish formal
relationships with Federally qualified health
centers, rural health centers, or accredited
teaching facilities and that conduct training
of students, residents, fellows, or faculty at
the center or facility.
(5) Qualified applicants that conduct teaching programs targeting vulnerable populations
such as older adults, homeless individuals, victims of abuse or trauma, individuals with
mental health or substance-related disorders,
individuals with disabilities, and individuals
with HIV/AIDS, and in the risk-based clinical
disease management of all populations.
(6) Qualified applicants that include educational activities in cultural competency and
health literacy.
(7) Qualified applicants that have a high rate
for placing graduates in practice settings that
serve underserved areas or health disparity
populations, or who achieve a significant increase in the rate of placing graduates in such
settings.
(8) Qualified applicants that intend to establish a special populations oral health care education center or training program for the didactic and clinical education of dentists, dental health professionals, and dental hygienists
who plan to teach oral health care for people
with developmental disabilities, cognitive impairment, complex medical problems, significant physical limitations, and vulnerable elderly.
(d) Application
An eligible entity desiring a grant under this
section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may
require.
(e) Duration of award
The period during which payments are made
to an entity from an award of a grant or contract under subsection (a) shall be 5 years. The
provision of such payments shall be subject to
annual approval by the Secretary and subject to
the availability of appropriations for the fiscal
year involved to make the payments.
(f) Authorizations of appropriations
For the purpose of carrying out subsections (a)
and (b), there is authorized to be appropriated
$30,000,000 for fiscal year 2010 and such sums as

§ 293l

may be necessary for each of fiscal years 2011
through 2015.
(g) Carryover funds
An entity that receives an award under this
section may carry over funds from 1 fiscal year
to another without obtaining approval from the
Secretary. In no case may any funds be carried
over pursuant to the preceding sentence for
more than 3 years.
(July 1, 1944, ch. 373, title VII, § 748, as added
Pub. L. 111–148, title V, § 5303(2), Mar. 23, 2010, 124
Stat. 618.)
PRIOR PROVISIONS
A prior section 748 of act July 1, 1944, was renumbered
section 749 and is classified to section 293l of this title.
Another prior section 748 of act July 1, 1944, was classified to section 293l of this title prior to repeal by Pub.
L. 105–392.
Another prior section 748 of act July 1, 1944, was classified to section 294r of this title prior to renumbering
by Pub. L. 97–35.

§ 293l. Advisory Committee on Training in Primary Care Medicine and Dentistry
(a) Establishment
The Secretary shall establish an advisory
committee to be known as the Advisory Committee on Training in Primary Care Medicine
and Dentistry (in this section referred to as the
‘‘Advisory Committee’’).
(b) Composition
(1) In general
The Secretary shall determine the appropriate number of individuals to serve on the
Advisory Committee. Such individuals shall
not be officers or employees of the Federal
Government.
(2) Appointment
Not later than 90 days after November 13,
1998, the Secretary shall appoint the members
of the Advisory Committee from among individuals who are health professionals. In making such appointments, the Secretary shall ensure a fair balance between the health professions, that at least 75 percent of the members
of the Advisory Committee are health professionals, a broad geographic representation of
members and a balance between urban and
rural members. Members shall be appointed
based on their competence, interest, and
knowledge of the mission of the profession involved.
(3) Minority representation
In appointing the members of the Advisory
Committee under paragraph (2), the Secretary
shall ensure the adequate representation of
women and minorities.
(c) Terms
(1) In general
A member of the Advisory Committee shall
be appointed for a term of 3 years, except that
of the members first appointed—
(A) 1⁄3 of such members shall serve for a
term of 1 year;
(B) 1⁄3 of such members shall serve for a
term of 2 years; and

§ 293l

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) 1⁄3 of such members shall serve for a
term of 3 years.
(2) Vacancies
(A) In general
A vacancy on the Advisory Committee
shall be filled in the manner in which the
original appointment was made and shall be
subject to any conditions which applied with
respect to the original appointment.
(B) Filling unexpired term
An individual chosen to fill a vacancy
shall be appointed for the unexpired term of
the member replaced.
(d) Duties
The Advisory Committee shall—
(1) provide advice and recommendations to
the Secretary concerning policy and program
development and other matters of significance
concerning the activities under section 293k of
this title;
(2) not later than 3 years after November 13,
1998, and annually thereafter, prepare and submit to the Secretary, and the Committee on
Labor and Human Resources of the Senate,
and the Committee on Commerce of the House
of Representatives, a report describing the activities of the Committee, including findings
and recommendations made by the Committee
concerning the activities under section 293k of
this title;
(3) develop, publish, and implement performance measures for programs under this part;
(4) develop and publish guidelines for longitudinal evaluations (as described in section
294n(d)(2) of this title) for programs under this
part; and
(5) recommend appropriation levels for programs under this part.
(e) Meetings and documents
(1) Meetings
The Advisory Committee shall meet not less
than 2 times each year. Such meetings shall be
held jointly with other related entities established under this subchapter where appropriate.
(2) Documents
Not later than 14 days prior to the convening
of a meeting under paragraph (1), the Advisory
Committee shall prepare and make available
an agenda of the matters to be considered by
the Advisory Committee at such meeting. At
any such meeting, the Advisory Council 1 shall
distribute materials with respect to the issues
to be addressed at the meeting. Not later than
30 days after the adjourning of such a meeting,
the Advisory Committee shall prepare and
make available a summary of the meeting and
any actions taken by the Committee based
upon the meeting.
(f) Compensation and expenses
(1) Compensation
Each member of the Advisory Committee
shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic
1 So

in original. Probably should be ‘‘Committee’’.

Page 788

pay prescribed for level IV of the Executive
Schedule under section 5315 of title 5 for each
day (including travel time) during which such
member is engaged in the performance of the
duties of the Committee.
(2) Expenses
The members of the Advisory Committee
shall be allowed travel expenses, including per
diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I
of chapter 57 of title 5 while away from their
homes or regular places of business in the performance of services for the Committee.
(g) FACA
The Federal Advisory Committee Act shall
apply to the Advisory Committee under this section only to the extent that the provisions of
such Act do not conflict with the requirements
of this section.
(July 1, 1944, ch. 373, title VII, § 749, formerly
§ 748, as added Pub. L. 105–392, title I, § 102(4),
Nov. 13, 1998, 112 Stat. 3539; renumbered § 749 and
amended Pub. L. 111–148, title V, §§ 5103(d)(1),
5303(1), Mar. 23, 2010, 124 Stat. 605, 618.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (g), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5,
Government Organization and Employees.
CODIFICATION
November 13, 1998, referred to in subsec. (b)(2), was in
the original ‘‘the date of enactment of this Act’’, which
was translated as meaning the date of enactment of
Pub. L. 105–392, which enacted this section, to reflect
the probable intent of Congress.
PRIOR PROVISIONS
A prior section 293l, act July 1, 1944, ch. 373, title VII,
§ 748, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2043; amended Pub. L. 102–531, title III,
§ 313(a)(3), Oct. 27, 1992, 106 Stat. 3507, authorized grants
and contracts for development of general internal medicine and general pediatrics training programs, prior to
repeal by Pub. L. 105–392, title I, § 102(4), Nov. 13, 1998,
112 Stat. 3539.
A prior section 749 of act July 1, 1944, was classified
to section 293m of this title prior to repeal by Pub. L.
105–392.
Another prior section 749 of act July 1, 1944, was classified to section 294s of this title prior to renumbering
by Pub. L. 97–35.
AMENDMENTS
2010—Subsec. (d)(3) to (5). Pub. L. 111–148, § 5103(d)(1),
added pars. (3) to (5).
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an

Page 789

TITLE 42—THE PUBLIC HEALTH AND WELFARE

advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 293l–1. Teaching health centers development
grants
(a) Program authorized
The Secretary may award grants under this
section to teaching health centers for the purpose of establishing new accredited or expanded
primary care residency programs.
(b) Amount and duration
Grants awarded under this section shall be for
a term of not more than 3 years and the maximum award may not be more than $500,000.
(c) Use of funds
Amounts provided under a grant under this
section shall be used to cover the costs of—
(1) establishing or expanding a primary care
residency training program described in subsection (a), including costs associated with—
(A) curriculum development;
(B) recruitment, training and retention of
residents and faculty: 1
(C) accreditation by the Accreditation
Council for Graduate Medical Education
(ACGME), the American Dental Association
(ADA), or the American Osteopathic Association (AOA); and
(D) faculty salaries during the development phase; and
(2) technical assistance provided by an eligible entity.
(d) Application
A teaching health center seeking a grant
under this section shall submit an application to
the Secretary at such time, in such manner, and
containing such information as the Secretary
may require.
(e) Preference for certain applications
In selecting recipients for grants under this
section, the Secretary shall give preference to
any such application that documents an existing
affiliation agreement with an area health education center program as defined in sections
294a and 295p of this title.
(f) Definitions
In this section:
(1) Eligible entity
The term ‘‘eligible entity’’ means an organization capable of providing technical assistance including an area health education center program as defined in sections 294a and
295p of this title.
(2) Primary care residency program
The term ‘‘primary care residency program’’
means an approved graduate medical residency training program (as defined in section
256h of this title) in family medicine, internal
medicine, pediatrics, internal medicine-pediatrics, obstetrics and gynecology, psychiatry,
general dentistry, pediatric dentistry, and geriatrics.
1 So

in original. The colon probably should be a semicolon.

§ 293m

(3) Teaching health center
(A) In general
The term ‘‘teaching health center’’ means
an entity that—
(i) is a community based, ambulatory patient care center; and
(ii) operates a primary care residency
program.
(B) Inclusion of certain entities
Such term includes the following:
(i) A Federally qualified health center
(as defined in section 1396d(l)(2)(B) of this
title).
(ii) A community mental health center
(as defined in section 1395x(ff)(3)(B) of this
title).
(iii) A rural health clinic, as defined in
section 1395x(aa) of this title.
(iv) A health center operated by the Indian Health Service, an Indian tribe or
tribal organization, or an urban Indian organization (as defined in section 1603 of
title 25).
(v) An entity receiving funds under subchapter VIII.
(g) Authorization of appropriations
There is authorized to be appropriated,
$25,000,000 for fiscal year 2010, $50,000,000 for fiscal year 2011, $50,000,000 for fiscal year 2012, and
such sums as may be necessary for each fiscal
year thereafter to carry out this section. Not to
exceed $5,000,000 annually may be used for technical assistance program grants.
(July 1, 1944, ch. 373, title VII, § 749A, as added
Pub. L. 111–148, title V, § 5508(a), Mar. 23, 2010, 124
Stat. 668.)
SUBPART 2—TRAINING IN UNDERSERVED
COMMUNITIES

§ 293m. Rural physician training grants
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a grant program
for the purposes of assisting eligible entities in
recruiting students most likely to practice medicine in underserved rural communities, providing rural-focused training and experience, and
increasing the number of recent allopathic and
osteopathic medical school graduates who practice in underserved rural communities.
(b) Eligible entities
In order to be eligible to receive a grant under
this section, an entity shall—
(1) be a school of allopathic or osteopathic
medicine accredited by a nationally recognized accrediting agency or association approved by the Secretary for this purpose, or
any combination or consortium of such
schools; and
(2) submit an application to the Secretary
that includes a certification that such entity
will use amounts provided to the institution
as described in subsection (d)(1).
(c) Priority
In awarding grant funds under this section,
the Secretary shall give priority to eligible entities that—

§§ 293n to 293p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) demonstrate a record of successfully
training students, as determined by the Secretary, who practice medicine in underserved
rural communities;
(2) demonstrate that an existing academic
program of the eligible entity produces a high
percentage, as determined by the Secretary, of
graduates from such program who practice
medicine in underserved rural communities;
(3) demonstrate rural community institutional partnerships, through such mechanisms
as matching or contributory funding, documented in-kind services for implementation,
or existence of training partners with interprofessional expertise in community health
center training locations or other similar facilities; or
(4) submit, as part of the application of the
entity under subsection (b), a plan for the
long-term tracking of where the graduates of
such entity practice medicine.
(d) Use of funds
(1) Establishment
An eligible entity receiving a grant under
this section shall use the funds made available
under such grant to establish, improve, or expand a rural-focused training program (referred to in this section as the ‘‘Program’’)
meeting the requirements described in this
subsection and to carry out such program.
(2) Structure of Program
An eligible entity shall—
(A) enroll no fewer than 10 students per
class year into the Program; and
(B) develop criteria for admission to the
Program that gives priority to students—
(i) who have originated from or lived for
a period of 2 or more years in an underserved rural community; and
(ii) who express a commitment to practice medicine in an underserved rural community.
(3) Curricula
The Program shall require students to enroll
in didactic coursework and clinical experience
particularly applicable to medical practice in
underserved rural communities, including—
(A) clinical rotations in underserved rural
communities, and in applicable specialties,
or other coursework or clinical experience
deemed appropriate by the Secretary; and
(B) in addition to core school curricula,
additional coursework or training experiences focused on medical issues prevalent in
underserved rural communities.
(4) Residency placement assistance
Where available, the Program shall assist all
students of the Program in obtaining clinical
training experiences in locations with postgraduate programs offering residency training
opportunities in underserved rural communities, or in local residency training programs
that support and train physicians to practice
in underserved rural communities.
(5) Program student cohort support
The Program shall provide and require all
students of the Program to participate in

Page 790

group activities designed to further develop,
maintain, and reinforce the original commitment of such students to practice in an underserved rural community.
(e) Annual reporting
An eligible entity receiving a grant under this
section shall submit an annual report to the
Secretary on the success of the Program, based
on criteria the Secretary determines appropriate, including the residency program selection of graduating students who participated in
the Program.
(f) Regulations
Not later than 60 days after March 23, 2010, the
Secretary shall by regulation define ‘‘underserved rural community’’ for purposes of this
section.
(g) Supplement not supplant
Any eligible entity receiving funds under this
section shall use such funds to supplement, not
supplant, any other Federal, State, and local
funds that would otherwise be expended by such
entity to carry out the activities described in
this section.
(h) Maintenance of effort
With respect to activities for which funds
awarded under this section are to be expended,
the entity shall agree to maintain expenditures
of non-Federal amounts for such activities at a
level that is not less than the level of such expenditures maintained by the entity for the fiscal year preceding the fiscal year for which the
entity receives a grant under this section.
(i) Authorization of appropriations
There are authorized to be appropriated
$4,000,000 for each of the fiscal years 2010
through 2013.
(July 1, 1944, ch. 373, title VII, § 749B, as added
Pub. L. 111–148, title X, § 10501(l)(2), Mar. 23, 2010,
124 Stat. 1000.)
PRIOR PROVISIONS
A prior section 293m, act July 1, 1944, ch. 373, title
VII, § 749, as added Pub. L. 102–408, title I, § 102, Oct. 13,
1992, 106 Stat. 2043, authorized grants and contracts for
development of programs in general practice of dentistry, prior to repeal by Pub. L. 105–392, title I, § 102(4),
Nov. 13, 1998, 112 Stat. 3539.

§§ 293n to 293p. Repealed. Pub. L. 105–392, title I,
§ 102(4), Nov. 13, 1998, 112 Stat. 3539
Section 293n, act July 1, 1944, ch. 373, title VII, § 750,
as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2044, authorized grants and contracts for development of training programs for physician assistants.
Section 293o, act July 1, 1944, ch. 373, title VII, § 751,
as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2044, authorized grants and contracts for implementation of training projects for podiatric physicians.
Section 293p, act July 1, 1944, ch. 373, title VII, § 752,
as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2045, set forth general provisions relating to
traineeships and fellowships.

PART D—INTERDISCIPLINARY, COMMUNITY-BASED
LINKAGES
§ 294. General provisions
(a) Collaboration
To be eligible to receive assistance under this
part, an academic institution shall use such as-

Page 791

TITLE 42—THE PUBLIC HEALTH AND WELFARE

sistance in collaboration with 2 or more disciplines.
(b) Activities
An entity shall use assistance under this part
to carry out innovative demonstration projects
for strategic workforce supplementation activities as needed to meet national goals for interdisciplinary, community-based linkages. Such
assistance may be used consistent with this
part—
(1) to develop and support training programs;
(2) for faculty development;
(3) for model demonstration programs;
(4) for the provision of stipends for fellowship trainees;
(5) to provide technical assistance; and
(6) for other activities that will produce outcomes consistent with the purposes of this
part.
(July 1, 1944, ch. 373, title VII, § 750, as added
Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112
Stat. 3541.)
PRIOR PROVISIONS
A prior section 294, act July 1, 1944, ch. 373, title VII,
§ 761, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2045; amended Pub. L. 103–43, title XX,
§ 2014(e), June 10, 1993, 107 Stat. 217, authorized grants
for traineeships in health professions fields experiencing severe shortages of health professionals, prior to
the general amendment of this part by Pub. L. 105–392.
Another prior section 294, act July 1, 1944, ch. 373,
title VII, § 727, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2257; amended Dec. 19, 1977,
Pub. L. 95–215, § 4(e)(1), 91 Stat. 1506, stated purpose of
and authorized appropriations for Federal program of
student loan insurance, prior to the general amendment of this subchapter by Pub. L. 102–408. See sections
292 and 292p of this title.
Another prior section 294, act July 1, 1944, ch. 373,
title VII, § 740, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 170; amended Oct. 13, 1964, Pub. L. 88–654,
§ 1(a), (b), 78 Stat. 1086; Oct. 22, 1965, Pub. L. 89–290,
§§ 2(b), 4(a), (f)(1), (2), 79 Stat. 1056 to 1058; Nov. 2, 1966,
Pub. L. 89–709, § 3(a), (b), 80 Stat. 1103; Nov. 3, 1966, Pub.
L. 89–751, § 5(c)(1), 80 Stat. 1232; Aug. 16, 1968, Pub. L.
90–490, title I § 121(a)(1), (2), (5)(B), 82 Stat. 777, 778; Nov.
18, 1971, Pub. L. 92–157, title I, § 105(e)(1), (4), (f)(2), 85
Stat. 451; Aug. 23, 1974, Pub. L. 93–385, § 2(b), 88 Stat. 741;
Apr. 22, 1976, Pub. L. 94–278, title XI, 1105(b), 90 Stat.
416; Oct. 12, 1976, Pub. L. 94–484, title IV, § 402, 90 Stat.
2266, which related to loan agreements for the establishment of student loan funds, was transferred to section 294m of this title.
A prior section 750 of act July 1, 1944, was classified
to section 293n of this title prior to repeal by Pub. L.
105–392.

§ 294a. Area health education centers
(a) Establishment of awards
The Secretary shall make the following 2
types of awards in accordance with this section:
(1) Infrastructure development award
The Secretary shall make awards to eligible
entities to enable such entities to initiate
health care workforce educational programs
or to continue to carry out comparable programs that are operating at the time the
award is made by planning, developing, operating, and evaluating an area health education
center program.

§ 294a

(2) Point of service maintenance and enhancement award
The Secretary shall make awards to eligible
entities to maintain and improve the effectiveness and capabilities of an existing area
health education center program, and make
other modifications to the program that are
appropriate due to changes in demographics,
needs of the populations served, or other similar issues affecting the area health education
center program. For the purposes of this section, the term ‘‘Program’’ refers to the area
health education center program.
(b) Eligible entities; application
(1) Eligible entities
(A) Infrastructure development
For purposes of subsection (a)(1), the term
‘‘eligible entity’’ means a school of medicine
or osteopathic medicine, an incorporated
consortium of such schools, or the parent institutions of such a school. With respect to
a State in which no area health education
center program is in operation, the Secretary may award a grant or contract under
subsection (a)(1) to a school of nursing.
(B) Point of service maintenance and enhancement
For purposes of subsection (a)(2), the term
‘‘eligible entity’’ means an entity that has
received funds under this section, is operating an area health education center program, including an area health education
center or centers, and has a center or centers that are no longer eligible to receive financial assistance under subsection (a)(1).
(2) Application
An eligible entity desiring to receive an
award under this section shall submit to the
Secretary an application at such time, in such
manner, and containing such information as
the Secretary may require.
(c) Use of funds
(1) Required activities
An eligible entity shall use amounts awarded under a grant under subsection (a)(1) or
(a)(2) to carry out the following activities:
(A) Develop and implement strategies, in
coordination with the applicable one-stop
delivery system under section 2864(c) of title
29, to recruit individuals from underrepresented minority populations or from
disadvantaged or rural backgrounds into
health professions, and support such individuals in attaining such careers.
(B) Develop and implement strategies to
foster and provide community-based training and education to individuals seeking careers in health professions within underserved areas for the purpose of developing
and maintaining a diverse health care workforce that is prepared to deliver high-quality
care, with an emphasis on primary care, in
underserved areas or for health disparity
populations, in collaboration with other
Federal and State health care workforce development programs, the State workforce
agency, and local workforce investment
boards, and in health care safety net sites.

§ 294a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) Prepare individuals to more effectively
provide health services to underserved areas
and health disparity populations through
field placements or preceptorships in conjunction with community-based organizations, accredited primary care residency
training programs, Federally qualified
health centers, rural health clinics, public
health departments, or other appropriate facilities.
(D) Conduct and participate in interdisciplinary training that involves physicians, physician assistants, nurse practitioners, nurse midwives, dentists, psychologists,
pharmacists,
optometrists,
community
health workers, public and allied health professionals, or other health professionals, as
practicable.
(E) Deliver or facilitate continuing education and information dissemination programs for health care professionals, with an
emphasis on individuals providing care in
underserved areas and for health disparity
populations.
(F) Propose and implement effective program and outcomes measurement and evaluation strategies.
(G) Establish a youth public health program to expose and recruit high school students into health careers, with a focus on careers in public health.
(2) Innovative opportunities
An eligible entity may use amounts awarded
under a grant under subsection (a)(1) or subsection (a)(2) to carry out any of the following
activities:
(A) Develop and implement innovative curricula in collaboration with communitybased accredited primary care residency
training programs, Federally qualified
health centers, rural health clinics, behavioral and mental health facilities, public
health departments, or other appropriate facilities, with the goal of increasing the number of primary care physicians and other primary care providers prepared to serve in underserved areas and health disparity populations.
(B) Coordinate community-based participatory research with academic health centers, and facilitate rapid flow and dissemination of evidence-based health care information, research results, and best practices to
improve quality, efficiency, and effectiveness of health care and health care systems
within community settings.
(C) Develop and implement other strategies to address identified workforce needs
and increase and enhance the health care
workforce in the area served by the area
health education center program.
(d) Requirements
(1) Area health education center program
In carrying out this section, the Secretary
shall ensure the following:
(A) An entity that receives an award under
this section shall conduct at least 10 percent
of clinical education required for medical
students in community settings that are re-

Page 792

moved from the primary teaching facility of
the contracting institution for grantees that
operate a school of medicine or osteopathic
medicine. In States in which an entity that
receives an award under this section is a
nursing school or its parent institution, the
Secretary shall alternatively ensure that—
(i) the nursing school conducts at least
10 percent of clinical education required
for nursing students in community settings that are remote from the primary
teaching facility of the school; and
(ii) the entity receiving the award maintains a written agreement with a school of
medicine or osteopathic medicine to place
students from that school in training sites
in the area health education center program area.
(B) An entity receiving funds under subsection (a)(2) does not distribute such funding to a center that is eligible to receive
funding under subsection (a)(1).
(2) Area health education center
The Secretary shall ensure that each area
health education center program includes at
least 1 area health education center, and that
each such center—
(A) is a public or private organization
whose structure, governance, and operation
is independent from the awardee and the
parent institution of the awardee;
(B) is not a school of medicine or osteopathic medicine, the parent institution of
such a school, or a branch campus or other
subunit of a school of medicine or osteopathic medicine or its parent institution, or
a consortium of such entities;
(C) designates an underserved area or population to be served by the center which is
in a location removed from the main location of the teaching facilities of the schools
participating in the program with such center and does not duplicate, in whole or in
part, the geographic area or population
served by any other center;
(D) fosters networking and collaboration
among communities and between academic
health centers and community-based centers;
(E) serves communities with a demonstrated need of health professionals in
partnership with academic medical centers;
(F) addresses the health care workforce
needs of the communities served in coordination with the public workforce investment
system; and
(G) has a community-based governing or
advisory board that reflects the diversity of
the communities involved.
(e) Matching funds
With respect to the costs of operating a program through a grant under this section, to be
eligible for financial assistance under this section, an entity shall make available (directly or
through contributions from State, county or
municipal governments, or the private sector)
recurring non-Federal contributions in cash or
in kind, toward such costs in an amount that is
equal to not less than 50 percent of such costs.

Page 793

TITLE 42—THE PUBLIC HEALTH AND WELFARE

At least 25 percent of the total required nonFederal contributions shall be in cash. An entity
may apply to the Secretary for a waiver of not
more than 75 percent of the matching fund
amount required by the entity for each of the
first 3 years the entity is funded through a grant
under subsection (a)(1).
(f) Limitation
Not less than 75 percent of the total amount
provided to an area health education center program under subsection (a)(1) or (a)(2) shall be allocated to the area health education centers
participating in the program under this section.
To provide needed flexibility to newly funded
area health education center programs, the Secretary may waive the requirement in the sentence for the first 2 years of a new area health
education center program funded under subsection (a)(1).
(g) Award
An award to an entity under this section shall
be not less than $250,000 annually per area
health education center included in the program
involved. If amounts appropriated to carry out
this section are not sufficient to comply with
the preceding sentence, the Secretary may reduce the per center amount provided for in such
sentence as necessary, provided the distribution
established in subsection (j)(2) is maintained.
(h) Project terms
(1) In general
Except as provided in paragraph (2), the period during which payments may be made
under an award under subsection (a)(1) may
not exceed—
(A) in the case of a program, 12 years; or
(B) in the case of a center within a program, 6 years.
(2) Exception
The periods described in paragraph (1) shall
not apply to programs receiving point of service maintenance and enhancement awards
under subsection (a)(2) to maintain existing
centers and activities.
(i) Inapplicability of provision
Notwithstanding any other provision of this
subchapter, section 295j(a) of this title shall not
apply to an area health education center funded
under this section.
(j) Authorization of appropriations
(1) In general
There is authorized to be appropriated to
carry out this section $125,000,000 for each of
the fiscal years 2010 through 2014.
(2) Requirements
Of the amounts appropriated for a fiscal
year under paragraph (1)—
(A) not more than 35 percent shall be used
for awards under subsection (a)(1);
(B) not less than 60 percent shall be used
for awards under subsection (a)(2);
(C) not more than 1 percent shall be used
for grants and contracts to implement outcomes evaluation for the area health education centers; and
(D) not more than 4 percent shall be used
for grants and contracts to provide technical

§ 294b

assistance to entities receiving awards under
this section.
(3) Carryover funds
An entity that receives an award under this
section may carry over funds from 1 fiscal
year to another without obtaining approval
from the Secretary. In no case may any funds
be carried over pursuant to the preceding sentence for more than 3 years.
(k) Sense of Congress
It is the sense of the Congress that every State
have an area health education center program in
effect under this section.
(July 1, 1944, ch. 373, title VII, § 751, as added
Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112
Stat. 3541; amended Pub. L. 111–148, title V,
§ 5403(a), Mar. 23, 2010, 124 Stat. 644.)
PRIOR PROVISIONS
A prior section 294a, act July 1, 1944, ch. 373, title VII,
§ 762, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2046, authorized grants and contracts for public health special projects, prior to the general amendment of this part by Pub. L. 105–392.
Another prior section 294a, act July 1, 1944, ch. 373,
title VII, § 728, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2257; amended Dec. 19, 1977,
Pub. L. 95–215, § 4(e)(2)–(4), 91 Stat. 1506; Dec. 17, 1980,
Pub. L. 96–538, title IV, § 401, 94 Stat. 3192; Aug. 13, 1981,
Pub. L. 97–35, title XXVII, § 2726, 95 Stat. 916; Oct. 22,
1985, Pub. L. 99–129, title I, § 101, title II, § 208(h), 99 Stat.
523, 532; Nov. 4, 1988, Pub. L. 100–607, title VI,
§§ 602(a)–(d), 636, title VII, § 707, 102 Stat. 3122, 3149, 3159;
Nov. 18, 1988, Pub. L. 100–690, title II, § 2615(b), 102 Stat.
4239; Aug. 16, 1989, Pub. L. 101–93, § 5(g)(1), 103 Stat. 612,
related to Federal student loan insurance program,
prior to the general amendment of this subchapter by
Pub. L. 102–408. See section 292a of this title.
Another prior section 294a, act July 1, 1944, ch. 373,
title VII, § 741, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 171; amended Oct. 13, 1964, Pub. L. 88–654,
§ 1(c), (d), 78 Stat. 1086; Oct. 22, 1965, Pub. L. 89–290,
§ 4(b), (f)(3), (4), (g)(1), 79 Stat. 1057, 1058; Nov. 2, 1966,
Pub. L. 89–709, § 3(c), (d), 80 Stat. 1103; Nov. 3, 1966, Pub.
L. 89–751, § 4, 80 Stat. 1230; Aug. 16, 1968, Pub. L. 90–490,
title I, § 121(a)(3), (4), (5)(A), 82 Stat. 777; Nov. 18, 1971,
Pub. L. 92–157, title I, § 105(b)–(d), (e)(4), (f)(2), 85 Stat.
449–451; Oct. 27, 1972, Pub. L. 92–585, § 4, 86 Stat. 1293;
Oct. 12, 1976, Pub. L. 94–484, title IV, §§ 403(a), (b), (d),
407(d)(1), 90 Stat. 2266, 2279, which related to loan provisions, was transferred to section 294n of this title.
A prior section 751 of act July 1, 1944, was classified
to section 293o of this title prior to repeal by Pub. L.
105–392.
Another prior section 751 of act July 1, 1944, was classified to section 294r of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 751 of act July 1, 1944, was classified to section 294t of this title prior to renumbering
by Pub. L. 97–35.
AMENDMENTS
2010—Pub. L. 111–148 amended section generally. Prior
to amendment, section consisted of subsecs. (a) to (c)
which related to authority for provision of financial assistance, requirements for centers, and allocations and
costs.

§ 294b. Continuing educational support for
health professionals serving in underserved
communities
(a) In general
The Secretary shall make grants to, and enter
into contracts with, eligible entities to improve

§ 294c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health care, increase retention, increase representation of minority faculty members, enhance the practice environment, and provide information dissemination and educational support to reduce professional isolation through the
timely dissemination of research findings using
relevant resources.
(b) Eligible entities
For purposes of this section, the term ‘‘eligible entity’’ means an entity described in section
295o–1(b) of this title.
(c) Application
An eligible entity desiring to receive an award
under this section shall submit to the Secretary
an application at such time, in such manner,
and containing such information as the Secretary may require.
(d) Use of funds
An eligible entity shall use amounts awarded
under a grant or contract under this section to
provide innovative supportive activities to enhance education through distance learning, continuing educational activities, collaborative
conferences, and electronic and telelearning activities, with priority for primary care.
(e) Authorization
There is authorized to be appropriated to
carry out this section $5,000,000 for each of the
fiscal years 2010 through 2014, and such sums as
may be necessary for each subsequent fiscal
year.
(July 1, 1944, ch. 373, title VII, § 752, as added
Pub. L. 111–148, title V, § 5403(b), Mar. 23, 2010, 124
Stat. 648.)
PRIOR PROVISIONS
A prior section 294b, act July 1, 1944, ch. 373, title VII,
§ 752, as added Pub. L. 105–392, title I, § 103, Nov. 13, 1998,
112 Stat. 3544, related to health education and training
centers, prior to repeal by Pub. L. 111–148, title V,
§ 5403(b), Mar. 23, 2010, 124 Stat. 648.
Another prior section 294b, act July 1, 1944, ch. 373,
title VII, § 763, as added Pub. L. 102–408, title I, § 102,
Oct. 13, 1992, 106 Stat. 2047, authorized grants and contracts for development of preventive medicine and dental public health programs, prior to the general amendment of this part by Pub. L. 105–392.
Another prior section 294b, act July 1, 1944, ch. 373,
title VII, § 729, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2258; amended Dec. 19, 1977,
Pub. L. 95–215, § 4(e)(5), 91 Stat. 1506; Sept. 29, 1979, Pub.
L. 96–76, title II, § 201, 93 Stat. 582; Aug. 13, 1981, Pub. L.
97–35, title XXVII, § 2727, 95 Stat. 917; Oct. 22, 1985, Pub.
L. 99–129, title II, § 208(g)(1), 99 Stat. 531; Nov. 4, 1988,
Pub. L. 100–607, title VI, §§ 628(5), 629(b)(2), 102 Stat. 3145,
3146, related to limitations on individually insured
loans and loan insurance, prior to the general revision
of this subchapter by Pub. L. 102–408. See section 292b
of this title.
Another prior section 294b, act July 1, 1944, ch. 373,
title VII, § 742, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 172; amended Oct. 22, 1965, Pub. L. 89–290,
§ 4(c), 79 Stat. 1057; Nov. 2, 1966, Pub. L. 89–709, § 3(e), 80
Stat. 1103; Nov. 3, 1966, Pub. L. 89–751, § 5(b), 80 Stat.
1232; Aug. 16, 1968, Pub. L. 90–490, title I, § 121(b), 82 Stat.
778; July 9, 1971, Pub. L. 92–52, § 1(a), 85 Stat. 144; Nov.
18, 1971, Pub. L. 92–157, title I, § 105(a), (f)(2), 85 Stat. 449,
451; Aug. 23, 1974, Pub. L. 93–385, § 2(a), 88 Stat. 741; Apr.
22, 1976, Pub. L. 94–278, title XI, § 1105(a), 90 Stat. 416;
Oct. 12, 1976, Pub. L. 94–484, title I, § 101(e), title IV,
§§ 404, 406(d), 90 Stat. 2244, 2267, 2268, which related to
authorization of appropriations, was transferred to section 294o of this title.

Page 794

A prior section 752 of act July 1, 1944, was classified
to section 293p of this title prior to repeal by Pub. L.
105–392.
Another prior section 752 of act July 1, 1944, was classified to section 294u of this title prior to renumbering
by Pub. L. 97–35.

§ 294c. Education and training relating to geriatrics
(a) Geriatric education centers
(1) In general
The Secretary shall award grants or contracts under this section to entities described
in paragraphs 1 (1), (3), or (4) of section 295p of
this title, and section 296(2) of this title, for
the establishment or operation of geriatric
education centers.
(2) Requirements
A geriatric education center is a program
that—
(A) improves the training of health professionals in geriatrics, including geriatric
residencies, traineeships, or fellowships;
(B) develops and disseminates curricula relating to the treatment of the health problems of elderly individuals;
(C) supports the training and retraining of
faculty to provide instruction in geriatrics;
(D) supports continuing education of
health professionals who provide geriatric
care; and
(E) provides students with clinical training in geriatrics in nursing homes, chronic
and acute disease hospitals, ambulatory care
centers, and senior centers.
(b) Geriatric training regarding physicians and
dentists
(1) In general
The Secretary may make grants to, and
enter into contracts with, schools of medicine,
schools of osteopathic medicine, teaching hospitals, and graduate medical education programs, for the purpose of providing support
(including residencies, traineeships, and fellowships) for geriatric training projects to
train physicians, dentists and behavioral and
mental health professionals who plan to teach
geriatric medicine, geriatric behavioral or
mental health, or geriatric dentistry.
(2) Requirements
Each project for which a grant or contract is
made under this subsection shall—
(A) be staffed by full-time teaching physicians who have experience or training in
geriatric medicine or geriatric behavioral or
mental health;
(B) be staffed, or enter into an agreement
with an institution staffed by full-time or
part-time teaching dentists who have experience or training in geriatric dentistry;
(C) be staffed, or enter into an agreement
with an institution staffed by full-time or
part-time teaching behavioral mental health
professionals who have experience or training in geriatric behavioral or mental health;
(D) be based in a graduate medical education program in internal medicine or fam1 So

in original. Probably should be ‘‘paragraph’’.

Page 795

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ily medicine or in a department of geriatrics
or behavioral or mental health;
(E) provide training in geriatrics and exposure to the physical and mental disabilities
of elderly individuals through a variety of
service rotations, such as geriatric consultation services, acute care services, dental
services, geriatric behavioral or mental
health units, day and home care programs,
rehabilitation services, extended care facilities, geriatric ambulatory care and comprehensive evaluation units, and community
care programs for elderly individuals with
intellectual disabilities; and
(F) provide training in geriatrics through
one or both of the training options described
in subparagraphs (A) and (B) of paragraph
(3).
(3) Training options
The training options referred to in subparagraph (F) of paragraph (2) shall be as follows:
(A) A 1-year retraining program in geriatrics for—
(i) physicians who are faculty members
in departments of internal medicine, family medicine, gynecology, geriatrics, and
behavioral or mental health at schools of
medicine and osteopathic medicine;
(ii) dentists who are faculty members at
schools of dentistry or at hospital departments of dentistry; and
(iii) behavioral or mental health professionals who are faculty members in departments of behavioral or mental health;
and
(B) A 2-year internal medicine or family
medicine fellowship program providing emphasis in geriatrics, which shall be designed
to provide training in clinical geriatrics and
geriatrics research for—
(i) physicians who have completed graduate medical education programs in internal medicine, family medicine, behavioral
or mental health, neurology, gynecology,
or rehabilitation medicine;
(ii) dentists who have demonstrated a
commitment to an academic career and
who have completed postdoctoral dental
training, including postdoctoral dental
education programs or who have relevant
advanced training or experience; and
(iii) behavioral or mental health professionals who have completed graduate medical education programs in behavioral or
mental health.
(4) Definitions
For purposes of this subsection:
(A) The term ‘‘graduate medical education
program’’ means a program sponsored by a
school of medicine, a school of osteopathic
medicine, a hospital, or a public or private
institution that—
(i) offers postgraduate medical training
in the specialties and subspecialties of
medicine; and
(ii) has been accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association through its Committee on Postdoctoral Training.

§ 294c

(B) The term ‘‘post-doctoral dental education program’’ means a program sponsored
by a school of dentistry, a hospital, or a public or private institution that—
(i) offers post-doctoral training in the
specialties of dentistry, advanced education in general dentistry, or a dental
general practice residency; and
(ii) has been accredited by the Commission on Dental Accreditation.
(c) Geriatric faculty fellowships
(1) Establishment of program
The Secretary shall establish a program to
provide Geriatric Academic Career Awards to
eligible individuals to promote the career development of such individuals as academic
geriatricians.
(2) Eligible individuals
To be eligible to receive an Award under
paragraph (1), an individual shall—
(A) be board certified or board eligible in
internal medicine, family practice, psychiatry, or licensed dentistry, or have completed
any required training in a discipline and employed in an accredited health professions
school that is approved by the Secretary;
(B) have completed an approved fellowship
program in geriatrics or have completed specialty training in geriatrics as required by
the discipline and any addition 2 geriatrics
training as required by the Secretary; and
(C) have a junior (non-tenured) faculty appointment at an accredited (as determined
by the Secretary) school of medicine, osteopathic medicine, nursing, social work, psychology, dentistry, pharmacy, or other allied health disciplines in an accredited
health professions school that is approved by
the Secretary.
(3) Limitations
No Award under paragraph (1) may be made
to an eligible individual unless the individual—
(A) has submitted to the Secretary an application, at such time, in such manner, and
containing such information as the Secretary may require, and the Secretary has
approved such application;
(B) provides, in such form and manner as
the Secretary may require, assurances that
the individual will meet the service requirement described in paragraph (6); and
(C) provides, in such form and manner as
the Secretary may require, assurances that
the individual has a full-time faculty appointment in a health professions institution and documented commitment from such
institution to spend 75 percent of the total
time of such individual on teaching and developing skills in interdisciplinary education in geriatrics.
(4) Maintenance of effort
An eligible individual that receives an
Award under paragraph (1) shall provide assurances to the Secretary that funds provided to
the eligible individual under this subsection
2 So

in original. Probably should be ‘‘additional’’.

§ 294c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

will be used only to supplement, not to supplant, the amount of Federal, State, and local
funds otherwise expended by the eligible individual.
(5) Amount and term
(A) Amount
The amount of an Award under this section for individuals who are physicians shall
equal $50,000 for fiscal year 1998, adjusted for
subsequent fiscal years to reflect the increase in the Consumer Price Index. The
Secretary shall determine the amount of an
Award under this section for individuals who
are not physicians.
(B) Term
The term of any Award made under this
subsection shall not exceed 5 years.
(C) Payment to institution
The Secretary shall make payments to institutions which include schools of medicine,
osteopathic medicine, nursing, social work,
psychology, dentistry, and pharmacy, or
other allied health discipline in an accredited health professions school that is approved by the Secretary.
(6) Service requirement
An individual who receives an Award under
this subsection shall provide training in clinical geriatrics, including the training of interdisciplinary teams of health care professionals. The provision of such training shall
constitute at least 75 percent of the obligations of such individual under the Award.
(d) Geriatric workforce development
(1) In general
The Secretary shall award grants or contracts under this subsection to entities that
operate a geriatric education center pursuant
to subsection (a)(1).
(2) Application
To be eligible for an award under paragraph
(1), an entity described in such paragraph shall
submit to the Secretary an application at such
time, in such manner, and containing such information as the Secretary may require.
(3) Use of funds
Amounts awarded under a grant or contract
under paragraph (1) shall be used to—
(A) carry out the fellowship program described in paragraph (4); and
(B) carry out 1 of the 2 activities described
in paragraph (5).
(4) Fellowship program
(A) In general
Pursuant to paragraph (3), a geriatric education center that receives an award under
this subsection shall use such funds to offer
short-term intensive courses (referred to in
this subsection as a ‘‘fellowship’’) that focus
on geriatrics, chronic care management, and
long-term care that provide supplemental
training for faculty members in medical
schools and other health professions schools
with programs in psychology, pharmacy,
nursing, social work, dentistry, public

Page 796

health, allied health, or other health disciplines, as approved by the Secretary. Such
a fellowship shall be open to current faculty,
and appropriately credentialed volunteer
faculty and practitioners, who do not have
formal training in geriatrics, to upgrade
their knowledge and clinical skills for the
care of older adults and adults with functional limitations and to enhance their
interdisciplinary teaching skills.
(B) Location
A fellowship shall be offered either at the
geriatric education center that is sponsoring
the course, in collaboration with other geriatric education centers, or at medical
schools, schools of dentistry, schools of nursing, schools of pharmacy, schools of social
work, graduate programs in psychology, or
allied health and other health professions
schools approved by the Secretary with
which the geriatric education centers are affiliated.
(C) CME credit
Participation in a fellowship under this
paragraph shall be accepted with respect to
complying with continuing health profession
education requirements. As a condition of
such acceptance, the recipient shall agree to
subsequently provide a minimum of 18 hours
of voluntary instructional support through a
geriatric education center that is providing
clinical training to students or trainees in
long-term care settings.
(5) Additional required activities described
Pursuant to paragraph (3), a geriatric education center that receives an award under
this subsection shall use such funds to carry
out 1 of the following 2 activities.
(A) Family caregiver and direct care provider training
A geriatric education center that receives
an award under this subsection shall offer at
least 2 courses each year, at no charge or
nominal cost, to family caregivers and direct care providers that are designed to provide practical training for supporting frail
elders and individuals with disabilities. The
Secretary shall require such Centers to work
with appropriate community partners to develop training program content and to publicize the availability of training courses in
their service areas. All family caregiver and
direct care provider training programs shall
include instruction on the management of
psychological and behavioral aspects of dementia, communication techniques for
working with individuals who have dementia, and the appropriate, safe, and effective
use of medications for older adults.
(B) Incorporation of best practices
A geriatric education center that receives
an award under this subsection shall develop
and include material on depression and
other mental disorders common among older
adults, medication safety issues for older
adults, and management of the psychological and behavioral aspects of dementia
and communication techniques with individ-

Page 797

TITLE 42—THE PUBLIC HEALTH AND WELFARE

uals who have dementia in all training
courses, where appropriate.
(6) Targets
A geriatric education center that receives an
award under this subsection shall meet targets
approved by the Secretary for providing geriatric training to a certain number of faculty
or practitioners during the term of the award,
as well as other parameters established by the
Secretary.
(7) Amount of award
An award under this subsection shall be in
an amount of $150,000. Not more than 24 geriatric education centers may receive an award
under this subsection.
(8) Maintenance of effort
A geriatric education center that receives an
award under this subsection shall provide assurances to the Secretary that funds provided
to the geriatric education center under this
subsection will be used only to supplement,
not to supplant, the amount of Federal, State,
and local funds otherwise expended by the
geriatric education center.
(9) Authorization of appropriations
In addition to any other funding available to
carry out this section, there is authorized to
be appropriated to carry out this subsection,
$10,800,000 for the period of fiscal year 2011
through 2014.
(e) Geriatric career incentive awards
(1) In general
The Secretary shall award grants or contracts under this section to individuals described in paragraph (2) to foster greater interest among a variety of health professionals in
entering the field of geriatrics, long-term care,
and chronic care management.
(2) Eligible individuals
To be eligible to received an award under
paragraph (1), an individual shall—
(A) be an advanced practice nurse, a clinical social worker, a pharmacist, or student
of psychology who is pursuing a doctorate or
other advanced degree in geriatrics or related fields in an accredited health professions
school; and
(B) submit to the Secretary an application
at such time, in such manner, and containing such information as the Secretary may
require.
(3) Condition of award
As a condition of receiving an award under
this subsection, an individual shall agree that,
following completion of the award period, the
individual will teach or practice in the field of
geriatrics, long-term care, or chronic care
management for a minimum of 5 years under
guidelines set by the Secretary.
(4) Authorization of appropriations
There is authorized to be appropriated to
carry out this subsection, $10,000,000 for the
period of fiscal years 2011 through 2013.
(July 1, 1944, ch. 373, title VII, § 753, as added
Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112

§ 294d

Stat. 3544; amended Pub. L. 107–205, title II,
§ 202(b), Aug. 1, 2002, 116 Stat. 817; Pub. L. 111–148,
title V, § 5305(a), (b), Mar. 23, 2010, 124 Stat. 622,
624; Pub. L. 111–256, § 2(f)(5), Oct. 5, 2010, 124 Stat.
2644.)
PRIOR PROVISIONS
A prior section 294c, act July 1, 1944, ch. 373, title VII,
§ 765, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2047, authorized appropriations for purpose of
carrying out subpart I of this part, prior to the general
amendment of this part by Pub. L. 105–392.
Another prior section 294c, act July 1, 1944, ch. 373,
title VII, § 730, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2258, related to sources of
funds for eligible student loans, prior to the general
amendment of this subchapter by Pub. L. 102–408. See
section 292c of this title.
Another prior section 294c, act July 1, 1944, ch. 373,
title VII, § 743, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 172; amended Oct. 22, 1965, Pub. L. 89–290,
§ 4(d), 79 Stat. 1057; Nov. 3, 1966, Pub. L. 89–751, § 5(c)(2),
(3), 80 Stat. 1233; Aug. 16, 1968, Pub. L. 90–490, title I,
§ 121(c), 82 Stat. 778; July 9, 1971, Pub. L. 92–52, § 1(b), 85
Stat. 144; Nov. 18, 1971, Pub. L. 92–157, title I, § 105(e)(2),
(f)(2), 85 Stat. 451; Oct. 12, 1976, Pub. L. 94–484, title IV,
§§ 405, 406(e), 90 Stat. 2267, 2268, which related to the distribution of assets from loan funds, was transferred to
section 294p of this title.
AMENDMENTS
2010—Subsec. (b)(2)(E). Pub. L. 111–256 substituted
‘‘elderly individuals with intellectual disabilities’’ for
‘‘elderly mentally retarded individuals’’.
Subsec. (c)(2) to (4). Pub. L. 111–148, § 5305(b)(2), added
pars. (2) to (4) and struck out former pars. (2) and (3)
which described eligible individuals and limitations for
Geriatric Academic Career Awards. Former par. (4) redesignated (5).
Subsec. (c)(5). Pub. L. 111–148, § 5305(b)(1), redesignated par. (4) as (5). Former par. (5) redesignated (6).
Subsec. (c)(5)(A). Pub. L. 111–148, § 5305(b)(3)(A), inserted ‘‘for individuals who are physicians’’ before
‘‘shall equal’’ and inserted at end ‘‘The Secretary shall
determine the amount of an Award under this section
for individuals who are not physicians.’’
Subsec. (c)(5)(C). Pub. L. 111–148, § 5305(b)(3)(B), added
subpar. (C).
Subsec. (c)(6). Pub. L. 111–148, § 5305(b)(1), redesignated par. (5) as (6).
Subsecs. (d), (e). Pub. L. 111–148, § 5305(a), added subsecs. (d) and (e).
2002—Subsec. (a)(1). Pub. L. 107–205 substituted ‘‘, and
section 296(2) of this title,’’ for ‘‘, and section 298b(2) of
this title,’’.
DEFINITIONS
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 294d. Quentin N. Burdick program for rural
interdisciplinary training
(a) Grants
The Secretary may make grants or contracts
under this section to help entities fund authorized activities under an application approved
under subsection (c) of this section.
(b) Use of amounts
(1) In general
Amounts provided under subsection (a) of
this section shall be used by the recipients to
fund interdisciplinary training projects designed to—

§ 294e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) use new and innovative methods to
train health care practitioners to provide
services in rural areas;
(B) demonstrate and evaluate innovative
interdisciplinary methods and models designed to provide access to cost-effective
comprehensive health care;
(C) deliver health care services to individuals residing in rural areas;
(D) enhance the amount of relevant research conducted concerning health care issues in rural areas; and
(E) increase the recruitment and retention
of health care practitioners from rural areas
and make rural practice a more attractive
career choice for health care practitioners.
(2) Methods
A recipient of funds under subsection (a) of
this section may use various methods in carrying out the projects described in paragraph (1),
including—
(A) the distribution of stipends to students
of eligible applicants;
(B) the establishment of a post-doctoral
fellowship program;
(C) the training of faculty in the economic
and logistical problems confronting rural
health care delivery systems; or
(D) the purchase or rental of transportation and telecommunication equipment
where the need for such equipment due to
unique characteristics of the rural area is
demonstrated by the recipient.
(3) Administration
(A) In general
An applicant shall not use more than 10
percent of the funds made available to such
applicant under subsection (a) of this section
for administrative expenses.
(B) Training
Not more than 10 percent of the individuals receiving training with funds made
available to an applicant under subsection
(a) of this section shall be trained as doctors
of medicine or doctors of osteopathy.
(C) Limitation
An institution that receives a grant under
this section shall use amounts received
under such grant to supplement, not supplant, amounts made available by such institution for activities of the type described in
subsection (b)(1) of this section in the fiscal
year preceding the year for which the grant
is received.
(c) Applications
Applications submitted for assistance under
this section shall—
(1) be jointly submitted by at least two eligible applicants with the express purpose of assisting individuals in academic institutions in
establishing long-term collaborative relationships with health care providers in rural areas;
and
(2) designate a rural health care agency or
agencies for clinical treatment or training, including hospitals, community health centers,
migrant health centers, rural health clinics,

Page 798

community behavioral and mental health centers, long-term care facilities, Native Hawaiian health centers, or facilities operated by
the Indian Health Service or an Indian tribe or
tribal organization or Indian organization
under a contract with the Indian Health Service under the Indian Self-Determination Act
[25 U.S.C. 450f et seq.].
(d) Definitions
For the purposes of this section, the term
‘‘rural’’ means geographic areas that are located
outside of standard metropolitan statistical
areas.
(July 1, 1944, ch. 373, title VII, § 754, as added
Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112
Stat. 3547.)
REFERENCES IN TEXT
The Indian Self-Determination Act, referred to in
subsec. (c)(2), is title I of Pub. L. 93–638, Jan. 4, 1975, 88
Stat. 2206, as amended, which is classified principally
to part A (§ 450f et seq.) of subchapter II of chapter 14
of Title 25, Indians. For complete classification of this
Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.
PRIOR PROVISIONS
A prior section 294d, act July 1, 1944, ch. 373, title VII,
§ 766, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2047, authorized grants and contracts for development of advanced training of allied health professionals, prior to the general amendment of this part by
Pub. L. 105–392.
Another prior section 294d, act July 1, 1944, ch. 373,
title VII, § 731, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2258; amended Aug. 1, 1977,
Pub. L. 95–83, title III, § 307(c)(1), (2), 91 Stat. 389, 390;
Dec. 19, 1977, Pub. L. 95–215, § 4(a)–(d), (e)(6), 91 Stat.
1505, 1506; Dec. 17, 1980, Pub. L. 96–538, title IV, § 402, 94
Stat. 3192; Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2728, 95 Stat. 918; Oct. 22, 1985, Pub. L. 99–129, title II,
§§ 208(a), (b)(1), (2), (c)(1), (d), (i), 211(a)(2), 99 Stat.
529–532, 539; Nov. 4, 1988, Pub. L. 100–607, title VI,
§ 602(e), (f), 102 Stat. 3123; Apr. 6, 1991, Pub. L. 102–25,
title III, § 374, 105 Stat. 95; July 23, 1992, Pub. L. 102–325,
title IV, § 427(b)(2), 106 Stat. 549, related to eligibility of
borrowers and terms of insurance, prior to the general
amendment of this subchapter by Pub. L. 102–408. See
section 292d of this title.
Another prior section 294d, act July 1, 1944, ch. 373,
title VII, § 744, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 173; amended Oct. 22, 1965, Pub. L. 89–290,
§ 4(e), 79 Stat. 1057; Nov. 3, 1966, Pub. L. 89–751, § 5(a), 80
Stat. 1230; Aug. 16, 1968, Pub. L. 90–490, title I, § 121(d),
82 Stat. 778; July 9, 1971, Pub. L. 92–52, § 1(c), 85 Stat.
144; Nov. 18, 1971, Pub. L. 92–157, title I, § 105(e)(3), (f)(2),
85 Stat. 451, provided for loans to schools to capitalize
health professions student loan funds, prior to repeal
by Pub. L. 94–484, title IV, § 406(a)(1), Oct. 12, 1976, 90
Stat. 2268.

§ 294e. Allied health and other disciplines
(a) In general
The Secretary may make grants or contracts
under this section to help entities fund activities of the type described in subsection (b) of
this section.
(b) Activities
Activities of the type described in this subsection include the following:
(1) Assisting entities in meeting the costs
associated with expanding or establishing programs that will increase the number of indi-

Page 799

TITLE 42—THE PUBLIC HEALTH AND WELFARE

viduals trained in allied health professions.
Programs and activities funded under this
paragraph may include—
(A) those that expand enrollments in allied
health professions with the greatest shortages or whose services are most needed by
the elderly;
(B) those that provide rapid transition
training programs in allied health fields to
individuals who have baccalaureate degrees
in health-related sciences;
(C) those that establish community-based
allied health training programs that link
academic centers to rural clinical settings;
(D) those that provide career advancement
training for practicing allied health professionals;
(E) those that expand or establish clinical
training sites for allied health professionals
in medically underserved or rural communities in order to increase the number of individuals trained;
(F) those that develop curriculum that
will emphasize knowledge and practice in
the areas of prevention and health promotion, geriatrics, long-term care, home
health and hospice care, and ethics;
(G) those that expand or establish interdisciplinary training programs that promote
the effectiveness of allied health practitioners in geriatric assessment and the rehabilitation of the elderly;
(H) those that expand or establish demonstration centers to emphasize innovative
models to link allied health clinical practice, education, and research;
(I) those that provide financial assistance
(in the form of traineeships) to students who
are participants in any such program; and
(i) who plan to pursue a career in an allied health field that has a demonstrated
personnel shortage; and
(ii) who agree upon completion of the
training program to practice in a medically underserved community;
that shall be utilized to assist in the payment of all or part of the costs associated
with tuition, fees and such other stipends as
the Secretary may consider necessary; and
(J) those to meet the costs of projects to
plan, develop, and operate or maintain graduate programs in behavioral and mental
health practice.
(2) Planning and implementing projects in
preventive and primary care training for podiatric physicians in approved or provisionally
approved residency programs that shall provide financial assistance in the form of traineeships to residents who participate in such
projects and who plan to specialize in primary
care.
(3) Carrying out demonstration projects in
which chiropractors and physicians collaborate to identify and provide effective treatment for spinal and lower-back conditions.
(July 1, 1944, ch. 373, title VII, § 755, as added
Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112
Stat. 3548.)
PRIOR PROVISIONS
A prior section 294e, act July 1, 1944, ch. 373, title VII,
§ 767, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,

§ 294e–1

106 Stat. 2048, authorized grants and contracts for establishment of programs to increase number of allied
health professionals, prior to the general amendment of
this part by Pub. L. 105–392.
Another prior section 294e, act July 1, 1944, ch. 373,
title VII, § 732, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2260; amended Aug. 1, 1977,
Pub. L. 95–83, title III, § 307(c)(3), (4), 91 Stat. 390; Dec.
19, 1977, Pub. L. 95–215, § 4(e)(8), (9), 91 Stat. 1506; Aug.
13, 1981, Pub. L. 97–35, title XXVII, § 2729, 95 Stat. 918;
Oct. 22, 1985, Pub. L. 99–129, title II, § 208(e), 99 Stat. 531;
Nov. 4, 1988, Pub. L. 100–607, title VI, § 602(g), 102 Stat.
3123, related to certificates of loan insurance, prior to
the general amendment of this subchapter by Pub. L.
102–408. See section 292e of this title.
Another prior section 294e, act July 1, 1944, ch. 373,
title VII, § 744, formerly § 745, as added Sept. 24, 1963,
Pub. L. 88–129, § 2(b), 77 Stat. 173; amended Nov. 18, 1971,
Pub. L. 92–157, title I, § 105(f)(2), 85 Stat. 451; renumbered § 744, Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 406(a)(2), 90 Stat. 2268, which related to administrative
provisions, was transferred to section 294q of this title.

§ 294e–1. Mental and behavioral health education
and training grants
(a) Grants authorized
The Secretary may award grants to eligible
institutions of higher education to support the
recruitment of students for, and education and
clinical experience of the students in—
(1) baccalaureate, master’s, and doctoral degree programs of social work, as well as the
development of faculty in social work;
(2) accredited master’s, doctoral, internship,
and post-doctoral residency programs of psychology for the development and implementation of interdisciplinary training of psychology graduate students for providing behavioral and mental health services, including
substance abuse prevention and treatment
services;
(3) accredited institutions of higher education or accredited professional training programs that are establishing or expanding internships or other field placement programs in
child and adolescent mental health in psychiatry, psychology, school psychology, behavioral
pediatrics, psychiatric nursing, social work,
school social work, substance abuse prevention and treatment, marriage and family therapy, school counseling, or professional counseling; and
(4) State-licensed mental health nonprofit
and for-profit organizations to enable such organizations to pay for programs for preservice
or in-service training of paraprofessional child
and adolescent mental health workers.
(b) Eligibility requirements
To be eligible for a grant under this section,
an institution shall demonstrate—
(1) participation in the institutions’ programs of individuals and groups from different
racial, ethnic, cultural, geographic, religious,
linguistic, and class backgrounds, and different genders and sexual orientations;
(2) knowledge and understanding of the concerns of the individuals and groups described
in subsection (a); 1
(3) any internship or other field placement
program assisted under the grant will prioritize cultural and linguistic competency;
1 So

in original. Probably should be ‘‘paragraph (1);’’.

§ 294f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) the institution will provide to the Secretary such data, assurances, and information
as the Secretary may require; and
(5) with respect to any violation of the
agreement between the Secretary and the institution, the institution will pay such liquidated damages as prescribed by the Secretary by regulation.
(c) Institutional requirement
For grants authorized under subsection (a)(1),
at least 4 of the grant recipients shall be historically black colleges or universities or other minority-serving institutions.
(d) Priority
(1) In selecting the grant recipients in social
work under subsection (a)(1), the Secretary shall
give priority to applicants that—
(A) are accredited by the Council on Social
Work Education;
(B) have a graduation rate of not less than 80
percent for social work students; and
(C) exhibit an ability to recruit social workers from and place social workers in areas
with a high need and high demand population.
(2) In selecting the grant recipients in graduate psychology under subsection (a)(2), the Secretary shall give priority to institutions in
which training focuses on the needs of vulnerable groups such as older adults and children,
individuals with mental health or substance-related disorders, victims of abuse or trauma and
of
combat
stress
disorders
such
as
posttraumatic stress disorder and traumatic
brain injuries, homeless individuals, chronically
ill persons, and their families.
(3) In selecting the grant recipients in training
programs in child and adolescent mental health
under subsections (a)(3) and (a)(4), the Secretary
shall give priority to applicants that—
(A) have demonstrated the ability to collect
data on the number of students trained in
child and adolescent mental health and the
populations served by such students after
graduation or completion of preservice or inservice training;
(B) have demonstrated familiarity with evidence-based methods in child and adolescent
mental health services, including substance
abuse prevention and treatment services;
(C) have programs designed to increase the
number of professionals and paraprofessionals
serving high-priority populations and to applicants who come from high-priority communities and plan to serve medically underserved
populations, in health professional shortage
areas, or in medically underserved areas;
(D) offer curriculum taught collaboratively
with a family on the consumer and family
lived experience or the importance of familyprofessional or family-paraprofessional partnerships; and
(E) provide services through a community
mental health program described in section
300x–2(b)(1) of this title.
(e) Authorization of appropriation
For the fiscal years 2010 through 2013, there is
authorized to be appropriated to carry out this
section—
(1) $8,000,000 for training in social work in
subsection (a)(1);

Page 800

(2) $12,000,000 for training in graduate psychology in subsection (a)(2), of which not less
than $10,000,000 shall be allocated for doctoral,
postdoctoral, and internship level training;
(3) $10,000,000 for training in professional
child and adolescent mental health in subsection (a)(3); and
(4) $5,000,000 for training in paraprofessional
child and adolescent work in subsection (a)(4).
(July 1, 1944, ch. 373, title VII, § 756, as added
Pub. L. 111–148, title V, § 5306(a)(3), Mar. 23, 2010,
124 Stat. 626.)
CODIFICATION
Pub. L. 111–148, title V, § 5306(a)(3), Mar. 23, 2010, 124
Stat. 626, which directed the amendment of part D of
title VII by inserting section 756 after section 755, without specifying the act to be amended, was executed by
inserting section 756 after section 755 of act July 1, 1944,
to reflect the probable intent of Congress.
PRIOR PROVISIONS
A prior section 756 of act July 1, 1944, was renumbered
section 757 and is classified to section 294f of this title.
Another prior section 756 of act July 1, 1944, was renumbered section 338G, transferred to section 254q of
this title, and subsequently repealed by Pub. L. 100–177.
Another prior section 756 of act July 1, 1944, was classified to section 294f of this title prior to repeal by Pub.
L. 94–484.

§ 294f. Advisory Committee on Interdisciplinary,
Community-Based Linkages
(a) Establishment
The Secretary shall establish an advisory
committee to be known as the Advisory Committee on Interdisciplinary, Community-Based
Linkages (in this section referred to as the ‘‘Advisory Committee’’).
(b) Composition
(1) In general
The Secretary shall determine the appropriate number of individuals to serve on the
Advisory Committee. Such individuals shall
not be officers or employees of the Federal
Government.
(2) Appointment
Not later than 90 days after November 13,
1998, the Secretary shall appoint the members
of the Advisory Committee from among individuals who are health professionals from
schools of the types described in sections
294a(b)(1)(A), 294c(b), and 294e(b) of this title.
In making such appointments, the Secretary
shall ensure a fair balance between the health
professions, that at least 75 percent of the
members of the Advisory Committee are
health professionals, a broad geographic representation of members and a balance between
urban and rural members. Members shall be
appointed based on their competence, interest,
and knowledge of the mission of the profession
involved.
(3) Minority representation
In appointing the members of the Advisory
Committee under paragraph (2), the Secretary
shall ensure the adequate representation of
women and minorities.

Page 801

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Terms
(1) In general
A member of the Advisory Committee shall
be appointed for a term of 3 years, except that
of the members first appointed—
(A) 1⁄3 of the members shall serve for a
term of 1 year;
(B) 1⁄3 of the members shall serve for a
term of 2 years; and
(C) 1⁄3 of the members shall serve for a
term of 3 years.
(2) Vacancies
(A) In general
A vacancy on the Advisory Committee
shall be filled in the manner in which the
original appointment was made and shall be
subject to any conditions which applied with
respect to the original appointment.
(B) Filling unexpired term
An individual chosen to fill a vacancy
shall be appointed for the unexpired term of
the member replaced.
(d) Duties
The Advisory Committee shall—
(1) provide advice and recommendations to
the Secretary concerning policy and program
development and other matters of significance
concerning the activities under this part;
(2) not later than 3 years after November 13,
1998, and annually thereafter, prepare and submit to the Secretary, and the Committee on
Labor and Human Resources of the Senate,
and the Committee on Commerce of the House
of Representatives, a report describing the activities of the Committee, including findings
and recommendations made by the Committee
concerning the activities under this part;
(3) develop, publish, and implement performance measures for programs under this part;
(4) develop and publish guidelines for longitudinal evaluations (as described in section
294n(d)(2) of this title) for programs under this
part; and
(5) recommend appropriation levels for programs under this part.
(e) Meetings and documents
(1) Meetings
The Advisory Committee shall meet not less
than 3 times each year. Such meetings shall be
held jointly with other related entities established under this subchapter where appropriate.
(2) Documents
Not later than 14 days prior to the convening
of a meeting under paragraph (1), the Advisory
Committee shall prepare and make available
an agenda of the matters to be considered by
the Advisory Committee at such meeting. At
any such meeting, the Advisory Council 1 shall
distribute materials with respect to the issues
to be addressed at the meeting. Not later than
30 days after the adjourning of such a meeting,
the Advisory Committee shall prepare and
make available a summary of the meeting and
1 So

in original. Probably should be ‘‘Committee’’.

§ 294f

any actions taken by the Committee based
upon the meeting.
(f) Compensation and expenses
(1) Compensation
Each member of the Advisory Committee
shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic
pay prescribed for level IV of the Executive
Schedule under section 5315 of title 5 for each
day (including travel time) during which such
member is engaged in the performance of the
duties of the Committee.
(2) Expenses
The members of the Advisory Committee
shall be allowed travel expenses, including per
diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I
of chapter 57 of title 5 while away from their
homes or regular places of business in the performance of services for the Committee.
(g) FACA
The Federal Advisory Committee Act shall
apply to the Advisory Committee under this section only to the extent that the provisions of
such Act do not conflict with the requirements
of this section.
(July 1, 1944, ch. 373, title VII, § 757, formerly
§ 756, as added Pub. L. 105–392, title I, § 103, Nov.
13, 1998, 112 Stat. 3549; renumbered § 757 and
amended Pub. L. 111–148, title V, §§ 5103(d)(2),
5306(a)(2), (b), Mar. 23, 2010, 124 Stat. 606, 626,
628.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (g), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5,
Government Organization and Employees.
CODIFICATION
Pub. L. 111–148, title V, § 5306(a)(2), Mar. 23, 2010, 124
Stat. 626, which directed the amendment of part D of
title VII by redesignating section 756 as section 757,
without specifying the act to be amended, was executed
by redesignating section 756 of act July 1, 1944, as section 757 of the Act, to reflect the probable intent of
Congress.
November 13, 1998, referred to in subsec. (b)(2), was in
the original ‘‘the date of enactment of this Act’’, which
was translated as meaning the date of enactment of
Pub. L. 105–392, which amended this part generally, to
reflect the probable intent of Congress.
PRIOR PROVISIONS
A prior section 294f, act July 1, 1944, ch. 373, title VII,
§ 733, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 401(b)(3), 90 Stat. 2262; amended Dec. 19, 1977, Pub. L.
95–215, § 4(e)(10), 91 Stat. 1506; Nov. 6, 1978, Pub. L.
95–598, title III, § 327, 92 Stat. 2679; Aug. 13, 1981, Pub. L.
97–35, title XXVII, § 2730, 95 Stat. 919; July 1, 1988, Pub.
L. 100–360, title IV, § 411(f)(10)(C)(ii), 102 Stat. 781; Nov.
4, 1988, Pub. L. 100–607, title VI, § 602(h)–(k), 102 Stat.
3123; Aug. 16, 1989, Pub. L. 101–93, § 7, 103 Stat. 615, related to procedures upon default by borrower under student loan insurance program, prior to the general
amendment of this subchapter by Pub. L. 102–408. See
section 292f of this title.
Another prior section 294f, act July 1, 1944, ch. 373,
title VII, § 746, as added Aug. 16, 1968, Pub. L. 90–490,
title I, § 121(e), 82 Stat. 778; amended Nov. 18, 1971, Pub.
L. 92–157, title I, §§ 105(f)(2), 106(b)(5), 85 Stat. 451, 453,
provided for transfer of funds to scholarships in rela-

§ 294g

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion to loans to students studying in United States,
prior to repeal by Pub. L. 94–484, title IV, § 406(a)(1),
Oct. 12, 1976, 90 Stat. 2268.
A prior section 757 of act July 1, 1944, was classified
to section 294g of this title, prior to repeal by Pub. L.
111–148, title V, § 5306(a)(1), Mar. 23, 2010, 124 Stat. 626.
AMENDMENTS
2010—Subsec. (b)(2). Pub. L. 111–148, § 5306(b), substituted ‘‘294a(b)(1)(A), 294c(b), and 294e(b)’’ for
‘‘294a(a)(1)(A), 294a(a)(1)(B), 294c(b), 294d(3)(A), and
294e(b)’’.
Subsec. (d)(3) to (5). Pub. L. 111–148, § 5103(d)(2), added
pars. (3) to (5).
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 294g. Repealed. Pub. L. 111–148, title
§ 5306(a)(1), Mar. 23, 2010, 124 Stat. 626

V,

Section, act July 1, 1944, ch. 373, title VII, § 757, as
added Pub. L. 105–392, title I, § 103, Nov. 13, 1998, 112
Stat. 3551, authorized appropriations to carry out this
part.
CODIFICATION
Pub. L. 111–148, title V, § 5306(a)(1), Mar. 23, 2010, 124
Stat. 626, which directed the amendment of part D of
title VII by striking section 757, without specifying the
act to be amended, was executed by repealing this section, which was section 757 of act July 1, 1944, to reflect
the probable intent of Congress.
PRIOR PROVISIONS
A prior section 294g, act July 1, 1944, ch. 373, title VII,
§ 734, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 401(b)(3), 90 Stat. 2263; amended Oct. 22, 1985, Pub. L.
99–129, title II, § 208(f), 99 Stat. 531, related to establishment of a student loan insurance fund, prior to the general amendment of this subchapter by Pub. L. 102–408.
See section 292i of this title.
Another prior section 294g, act July 1, 1944, ch. 373,
title VII, § 747, as added Nov. 18, 1971, Pub. L. 92–157,
title I, § 105(f)(4), 85 Stat. 451; amended Oct. 12, 1976,
Pub. L. 94–484, title I, § 101(f), 90 Stat. 2244, provided for
student loans to citizens of United States who were
full-time students in schools of medicine located outside United States, prior to repeal by Pub. L. 94–484,
title IV, § 401(a), Oct. 12, 1976, 90 Stat. 2257, effective
Oct. 1, 1976.

§ 294h. Interdisciplinary training and education
on domestic violence and other types of violence and abuse
(a) Grants
The Secretary, acting through the Director of
the Health Resources and Services Administration, shall award grants under this section to de-

Page 802

velop interdisciplinary training and education
programs that provide undergraduate, graduate,
post-graduate medical, nursing (including advanced practice nursing students), and other
health professions students with an understanding of, and clinical skills pertinent to, domestic
violence, sexual assault, stalking, and dating
violence.
(b) Eligibility
To be eligible to receive a grant under this
section an entity shall—
(1) be an accredited school of allopathic or
osteopathic medicine;
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary
may require, including—
(A) information to demonstrate that the
applicant includes the meaningful participation of a school of nursing and at least one
other school of health professions or graduate program in public health, dentistry, social work, midwifery, or behavioral and
mental health;
(B) strategies for the dissemination and
sharing of curricula and other educational
materials developed under the grant to other
interested medical and nursing schools and
national resource repositories for materials
on domestic violence and sexual assault; and
(C) a plan for consulting with communitybased coalitions or individuals who have experience and expertise in issues related to
domestic violence, sexual assault, dating
violence, and stalking for services provided
under the program carried out under the
grant.
(c) Use of funds
(1) Required uses
Amounts provided under a grant under this
section shall be used to—
(A) fund interdisciplinary training and
education projects that are designed to train
medical, nursing, and other health professions students and residents to identify and
provide health care services (including mental or behavioral health care services and referrals to appropriate community services)
to individuals who are experiencing or who
have experienced domestic violence, sexual
assault, and stalking or dating violence; and
(B) plan and develop culturally competent
clinical components for integration into approved residency training programs that address health issues related to domestic violence, sexual assault, dating violence, and
stalking, along with other forms of violence
as appropriate, and include the primacy of
victim safety and confidentiality.
(2) Permissive uses
Amounts provided under a grant under this
section may be used to—
(A) offer community-based training opportunities in rural areas for medical, nursing,
and other students and residents on domestic violence, sexual assault, stalking, and
dating violence, and other forms of violence
and abuse, which may include the use of distance learning networks and other available

Page 803

TITLE 42—THE PUBLIC HEALTH AND WELFARE

technologies needed to reach isolated rural
areas; or
(B) provide stipends to students who are
underrepresented in the health professions
as necessary to promote and enable their
participation in clerkships, preceptorships,
or other offsite training experiences that are
designed to develop health care clinical
skills related to domestic violence, sexual
assault, dating violence, and stalking.
(3) Requirements
(A) Confidentiality and safety
Grantees under this section shall ensure
that all educational programs developed
with grant funds address issues of confidentiality and patient safety, and that faculty
and staff associated with delivering educational components are fully trained in
procedures that will protect the immediate
and ongoing security of the patients, patient
records, and staff. Advocacy-based coalitions
or other expertise available in the community shall be consulted on the development
and adequacy of confidentially and security
procedures, and shall be fairly compensated
by grantees for their services.
(B) Rural programs
Rural training programs carried out under
paragraph (2)(A) shall reflect adjustments in
protocols and procedures or referrals that
may be needed to protect the confidentiality
and safety of patients who live in small or
isolated communities and who are currently
or have previously experienced violence or
abuse.
(4) Child and elder abuse
Issues related to child and elder abuse may
be addressed as part of a comprehensive programmatic approach implemented under a
grant under this section.
(d) Requirements of grantees
(1) Limitation on administrative expenses
A grantee shall not use more than 10 percent
of the amounts received under a grant under
this section for administrative expenses.
(2) Contribution of funds
A grantee under this section, and any entity
receiving assistance under the grant for training and education, shall contribute non-Federal funds, either directly or through in-kind
contributions, to the costs of the activities to
be funded under the grant in an amount that
is not less than 25 percent of the total cost of
such activities.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $3,000,000 for each of fiscal years 2007 through 2011. Amounts appropriated under this subsection shall remain available until expended.
(July 1, 1944, ch. 373, title VII, § 758, as added
Pub. L. 109–162, title V, § 503, Jan. 5, 2006, 119
Stat. 3024; amended Pub. L. 109–271, § 4(c), Aug.
12, 2006, 120 Stat. 758.)
PRIOR PROVISIONS
A prior section 294h, act July 1, 1944, ch. 373, title VII,
§ 735, as added Oct. 12, 1976, Pub. L. 94–484, title IV,

§ 294i

§ 401(b)(3), 90 Stat. 2263; amended Aug. 1, 1977, Pub. L.
95–83, title III, § 307(c)(5), 91 Stat. 390; Aug. 13, 1981, Pub.
L. 97–35, title XXVII, § 2709(e)(4)(B), 95 Stat. 911; Nov. 16,
1990, Pub. L. 101–597, title IV, § 401(b)[(a)], 104 Stat. 3035,
related to functions, powers, and duties of the Secretary under the Federal student loan insurance program, prior to the general amendment of this subchapter by Pub. L. 102–408. See section 292j of this title.
AMENDMENTS
2006—Subsec. (c)(1)(A). Pub. L. 109–271 inserted ‘‘experiencing’’ after ‘‘to individuals who are’’.

§ 294i. Program for education and training in
pain care
(a) In general
The Secretary may make awards of grants, cooperative agreements, and contracts to health
professions schools, hospices, and other public
and private entities for the development and implementation of programs to provide education
and training to health care professionals in pain
care.
(b) Certain topics
An award may be made under subsection (a)
only if the applicant for the award agrees that
the program carried out with the award will include information and education on—
(1) recognized means for assessing, diagnosing, treating, and managing pain and related
signs and symptoms, including the medically
appropriate use of controlled substances;
(2) applicable laws, regulations, rules, and
policies on controlled substances, including
the degree to which misconceptions and concerns regarding such laws, regulations, rules,
and policies, or the enforcement thereof, may
create barriers to patient access to appropriate and effective pain care;
(3) interdisciplinary approaches to the delivery of pain care, including delivery through
specialized centers providing comprehensive
pain care treatment expertise;
(4) cultural, linguistic, literacy, geographic,
and other barriers to care in underserved populations; and
(5) recent findings, developments, and improvements in the provision of pain care.
(c) Evaluation of programs
The Secretary shall (directly or through
grants or contracts) provide for the evaluation
of programs implemented under subsection (a)
in order to determine the effect of such programs on knowledge and practice of pain care.
(d) Pain care defined
For purposes of this section the term ‘‘pain
care’’ means the assessment, diagnosis, treatment, or management of acute or chronic pain
regardless of causation or body location.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, such sums as may be necessary for each of the fiscal years 2010 through
2012. Amounts appropriated under this subsection shall remain available until expended.
(July 1, 1944, ch. 373, title VII, § 759, as added
Pub. L. 111–148, title IV, § 4305(c), Mar. 23, 2010,
124 Stat. 586.)

§ 294j

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 294i, act July 1, 1944, ch. 373, title VII,
§ 771, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2049, authorized grants to educational entities
offering programs in health administration, hospital
administration, or health policy analysis and planning,
prior to the general amendment of this part by Pub. L.
105–392.
Another prior section 294i, act July 1, 1944, ch. 373,
title VII, § 736, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 401(b)(3), 90 Stat. 2265; amended Aug. 1, 1977,
Pub. L. 95–83, title III, § 307(d), 91 Stat. 390, related to
participation by Federal credit unions in Federal,
State, and private student loan insurance programs,
prior to the general amendment of this subchapter by
Pub. L. 102–408. See section 292k of this title.
A prior section 759 of act July 1, 1944, was classified
to section 294aa of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.

§ 294j. Demonstration program to integrate quality improvement and patient safety training
into clinical education of health professionals
(a) In general
The Secretary may award grants to eligible
entities or consortia under this section to carry
out demonstration projects to develop and implement academic curricula that integrates 1
quality improvement and patient safety in the
clinical education of health professionals. Such
awards shall be made on a competitive basis and
pursuant to peer review.
(b) Eligibility
To be eligible to receive a grant under subsection (a), an entity or consortium shall—
(1) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require;
(2) be or include—
(A) a health professions school;
(B) a school of public health;
(C) a school of social work;
(D) a school of nursing;
(E) a school of pharmacy;
(F) an institution with a graduate medical
education program; or
(G) a school of health care administration;
(3) collaborate in the development of curricula described in subsection (a) with an organization that accredits such school or institution;
(4) provide for the collection of data regarding the effectiveness of the demonstration
project; and
(5) provide matching funds in accordance
with subsection (c).
(c) Matching funds
(1) In general
The Secretary may award a grant to an entity or consortium under this section only if
the entity or consortium agrees to make
available non-Federal contributions toward
the costs of the program to be funded under
the grant in an amount that is not less than $1
for each $5 of Federal funds provided under the
grant.
1 So

in original. Probably should be ‘‘integrate’’.

Page 804

(2) Determination of amount contributed
Non-Federal contributions under paragraph
(1) may be in cash or in-kind, fairly evaluated,
including equipment or services. Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent
by the Federal Government, may not be included in determining the amount of such contributions.
(d) Evaluation
The Secretary shall take such action as may
be necessary to evaluate the projects funded
under this section and publish, make publicly
available, and disseminate the results of such
evaluations on as wide a basis as is practicable.
(e) Reports
Not later than 2 years after March 23, 2010, and
annually thereafter, the Secretary shall submit
to the Committee on Health, Education, Labor,
and Pensions and the Committee on Finance of
the Senate and the Committee on Energy and
Commerce and the Committee on Ways and
Means of the House of Representatives a report
that—
(1) describes the specific projects supported
under this section; and
(2) contains recommendations for Congress
based on the evaluation conducted under subsection (d).
(Pub. L. 111–148, title III, § 3508, Mar. 23, 2010, 124
Stat. 530.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
PRIOR PROVISIONS
A prior section 294j, act July 1, 1944, ch. 373, title VII,
§ 737, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 401(b)(3), 90 Stat. 2265; amended Aug. 1, 1977, Pub. L.
95–83, title III, § 307(c)(6), 91 Stat. 390; Dec. 19, 1977, Pub.
L. 95–215, § 4(f), 91 Stat. 1506; Aug. 13, 1981, Pub. L. 97–35,
title XXVII, § 2731, 95 Stat. 919; Jan. 4, 1983, Pub. L.
97–414, § 8(i), 96 Stat. 2061; Oct. 22, 1985, Pub. L. 99–129,
title II, §§ 201(c), 204(c), 208(g)(2), 99 Stat. 525, 527, 531;
Nov. 4, 1988, Pub. L. 100–607, title VI, §§ 602(l), 628(6),
629(b)(2), 102 Stat. 3124, 3145, 3146, defined ‘‘eligible institution’’, ‘‘eligible lender’’, ‘‘line of credit’’, and
‘‘school of allied health’’, prior to the general amendment of this subchapter by Pub. L. 102–408, title I, § 102,
Oct. 13, 1992, 106 Stat. 1994. See section 292o of this title.
Sections 294j–1 to 294m were omitted in the general
amendment of this subchapter by Pub. L. 102–408, title
I, § 102, Oct. 13, 1992, 106 Stat. 1994.
Section 294j–1, act July 1, 1944, ch. 373, title VII,
§ 737A, as added Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2732, 95 Stat. 919, related to determination of eligible
students. See section 292l of this title.
Section 294k, act July 1, 1944, ch. 373, title VII, § 738,
as added Oct. 12, 1976, Pub. L. 94–484, title IV, § 401(b)(3),
90 Stat. 2265; amended Dec. 19, 1977, Pub. L. 95–215,
§ 4(e)(12), 91 Stat. 1506, related to repayment of loans of
deceased or disabled borrowers from student loan insurance fund. See section 292m of this title.
Section 294l, act July 1, 1944, ch. 373, title VII, § 739,
as added Oct. 12, 1976, Pub. L. 94–484, title IV, § 401(b)(3),
90 Stat. 2266; amended Dec. 19, 1977, Pub. L. 95–215,
§ 4(e)(13), 91 Stat. 1506; Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2733, 95 Stat. 920, related to eligibility of institutions and recordation and availability of information. See section 292n of this title.
Section 294l–1, act July 1, 1944, ch. 373, title VII,
§ 739A, as added Nov. 4, 1988, Pub. L. 100–607, title VI,

Page 805

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 602(m), 102 Stat. 3124, related to reissuance and refinancing of certain loans.
Section 294m, act July 1, 1944, ch. 373, title VII, § 740,
as added Sept. 24, 1963, Pub. L. 88–129, § 2(b), 77 Stat. 170;
amended Oct. 13, 1964, Pub. L. 88–654, § 1(a), (b), 78 Stat.
1086; Oct. 22, 1965, Pub. L. 89–290, §§ 2(b), 4 (a), (f)(1), (2),
79 Stat. 1056–1058; Nov. 2, 1966, Pub. L. 89–709, § 3(a), (b),
80 Stat. 1103; Nov. 3, 1966, Pub. L. 89–751, § 5(c)(1), 80
Stat. 1232; Aug. 16, 1968, Pub. L. 90–490, title I, § 121(a)(1),
(2), (5)(B), 82 Stat. 777, 778; Nov. 18, 1971, Pub. L. 92–157,
title I, § 105(e)(1), (4), (f)(2), 85 Stat. 451; Aug. 23, 1974,
Pub. L. 93–385, § 2(b), 88 Stat. 741; Apr. 22, 1976, Pub. L.
94–278, title XI, § 1105(b), 90 Stat. 416; Oct. 12, 1976, Pub.
L. 94–484, title IV, § 402, 90 Stat. 2266; Oct. 22, 1985, Pub.
L. 99–129, title II, § 209(a)(1), (j)(1), 99 Stat. 532, 536; Nov.
4, 1988, Pub. L. 100–607, title VI, §§ 603(a), 628(7), 629(b)(2),
102 Stat. 3125, 3145, 3146; Nov. 6, 1990, Pub. L. 101–527,
§ 5(a), (b), 104 Stat. 2322, 2323, related to loan agreements for establishment of student loan funds. See section 292q of this title.

PART E—HEALTH PROFESSIONS AND PUBLIC
HEALTH WORKFORCE
SUBPART 1—HEALTH PROFESSIONS WORKFORCE
INFORMATION AND ANALYSIS

§ 294n. Health professions workforce information
and analysis
(a) Purpose
It is the purpose of this section to—
(1) provide for the development of information describing the health professions workforce and the analysis of workforce related issues; and
(2) provide necessary information for decision-making regarding future directions in
health professions and nursing programs in response to societal and professional needs.
(b) National Center for Health Care Workforce
Analysis
(1) Establishment
The Secretary shall establish the National
Center for Health Workforce Analysis (referred to in this section as the ‘‘National Center’’).
(2) Purposes
The National Center, in coordination to the
extent practicable with the National Health
Care Workforce Commission (established in
section 294q of this title), and relevant regional and State centers and agencies, shall—
(A) provide for the development of information describing and analyzing the health
care workforce and workforce related issues;
(B) carry out the activities under section
295k(a) of this title;
(C) annually evaluate programs under this
subchapter;
(D) develop and publish performance measures and benchmarks for programs under
this subchapter; and
(E) establish, maintain, and publicize a national Internet registry of each grant awarded under this subchapter and a database to
collect data from longitudinal evaluations
(as described in subsection (d)(2)) on performance measures (as developed under sections 293l(d)(3), 294f(d)(3), and 294o(a)(3) of
this title).

§ 294n

(3) Collaboration and data sharing
(A) In general
The National Center shall collaborate with
Federal agencies and relevant professional
and educational organizations or societies
for the purpose of linking data regarding
grants awarded under this subchapter.
(B) Contracts for health workforce analysis
For the purpose of carrying out the activities described in subparagraph (A), the National Center may enter into contracts with
relevant professional and educational organizations or societies.
(c) State and regional Centers for Health Workforce Analysis
(1) In general
The Secretary shall award grants to, or
enter into contracts with, eligible entities for
purposes of—
(A) collecting, analyzing, and reporting
data regarding programs under this subchapter to the National Center and to the
public; and
(B) providing technical assistance to local
and regional entities on the collection,
analysis, and reporting of data.
(2) Eligible entities
To be eligible for a grant or contract under
this subsection, an entity shall—
(A) be a State, a State workforce investment board, a public health or health professions school, an academic health center, or
an appropriate public or private nonprofit
entity; and
(B) submit to the Secretary an application
at such time, in such manner, and containing such information as the Secretary may
require.
(d) Increase in grants for longitudinal evaluations
(1) In general
The Secretary shall increase the amount
awarded to an eligible entity under this subchapter for a longitudinal evaluation of individuals who have received education, training,
or financial assistance from programs under
this subchapter.
(2) Capability
A longitudinal evaluation shall be capable
of—
(A) studying practice patterns; and
(B) collecting and reporting data on performance measures developed under sections
293l(d)(3), 294f(d)(3), and 294o(a)(3) of this
title.
(3) Guidelines
A longitudinal evaluation shall comply with
guidelines issued under sections 293l(d)(4),
294f(d)(4), and 294o(a)(4) of this title.
(4) Eligible entities
To be eligible to obtain an increase under
this section, an entity shall be a recipient of a
grant or contract under this subchapter.

§ 294o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Authorization of appropriations
(1) In general
(A) National Center
To carry out subsection (b), there are authorized to be appropriated $7,500,000 for
each of fiscal years 2010 through 2014.
(B) State and regional Centers
To carry out subsection (c), there are authorized to be appropriated $4,500,000 for
each of fiscal years 2010 through 2014.
(C) Grants for longitudinal evaluations
To carry out subsection (d), there are authorized to be appropriated such sums as
may be necessary for fiscal years 2010
through 2014.
(2) Reservation
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall
reserve not less than $600,000 for conducting
health professions research and for carrying
out data collection and analysis in accordance
with section 295k of this title.
(3) Availability of additional funds
Amounts otherwise appropriated for programs or activities under this subchapter may
be used for activities under subsection (b) of
this section with respect to the programs or
activities from which such amounts were
made available.
(July 1, 1944, ch. 373, title VII, § 761, as added
Pub. L. 105–392, title I, § 104(a), Nov. 13, 1998, 112
Stat. 3552; amended Pub. L. 111–148, title V,
§ 5103(a), Mar. 23, 2010, 124 Stat. 603.)
PRIOR PROVISIONS
A prior section 294n, act July 1, 1944, ch. 373, title VII,
§ 776, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2050, and amended, which related to grants
and contracts to provide health care for individuals
with acquired immune deficiency syndrome, was renumbered section 2692 of title XXVI of act July 1, 1944,
by Pub. L. 104–146, § 3(h)(3), May 20, 1996, 110 Stat. 1364,
and transferred to section 300ff–111 of this title.
Another prior section 294n, act July 1, 1944, ch. 373,
title VII, § 741, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 171; amended Oct. 13, 1964, Pub. L. 88–654,
§ 1(c), (d), 78 Stat. 1086; Oct. 22, 1965, Pub. L. 89–290,
§ 4(b), (f)(3), (4), (g)(1), 79 Stat. 1057, 1058; Nov. 2, 1966,
Pub. L. 89–709, § 3(c), (d), 80 Stat. 1103; Nov. 3, 1966, Pub.
L. 89–751, § 4, 80 Stat. 1230; Aug. 16, 1968, Pub. L. 90–490,
title I, § 121(a)(3), (4), (5)(A), 82 Stat. 777; Nov. 18, 1971,
Pub. L. 92–157, title I, § 105(b)–(d), (e)(4), (f)(2), 85 Stat.
449–451; Oct. 27, 1972, Pub. L. 92–585, § 4, 86 Stat. 1293;
Oct. 12, 1976, Pub. L. 94–484, title IV, §§ 403(a), (b), (d),
407(d)(1), 90 Stat. 2266, 2267, 2279; Aug. 1, 1977, Pub. L.
95–83, title III, § 307(e)(1), (2), 91 Stat. 390; Aug. 13, 1981,
Pub. L. 97–35, title XXVII, § 2735, 95 Stat. 920; Oct. 22,
1985, Pub. L. 99–129, title II, § 209(a)(2), (3), (b), (c)(1),
(d)–(f), 99 Stat. 532, 534; Nov. 4, 1988, Pub. L. 100–607,
title VI, §§ 603(b), (c), 628(8), 629(b)(2), 102 Stat. 3125, 3145,
3146; Nov. 16, 1990, Pub. L. 101–597, title IV, § 401(b)[(a)],
104 Stat. 3035, outlined provisions for loans from a student loan fund, prior to the general amendment of this
subchapter by Pub. L. 102–408. See section 292r of this
title.
A prior section 761 of act July 1, 1944, was classified
to section 294 of this title prior to the general amendment of part D of this subchapter by Pub. L. 105–392.
Another prior section 761 of act July 1, 1944, was classified to section 294cc of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.

Page 806

Another prior section 761 of act July 1, 1944, was classified to section 295 of this title prior to repeal by Pub.
L. 99–129.
Another prior section 761 of act July 1, 1944, was classified to section 295 of this title prior to the general
amendment of part D of this subchapter by Pub. L.
91–696.
AMENDMENTS
2010—Subsecs. (b) to (e). Pub. L. 111–148, § 5103(a)(1),
(2), added subsecs. (b) to (d), redesignated former subsec. (c) as (e), and struck out former subsec. (b) which
related to award of grants or contracts.
Subsec. (e)(1). Pub. L. 111–148, § 5103(a)(3)(A), added
par. (1) and struck out former par. (1). Prior to amendment, text read as follows: ‘‘There are authorized to be
appropriated to carry out this section, $750,000 for fiscal
year 1998, and such sums as may be necessary for each
of the fiscal years 1999 through 2002.’’
Subsec. (e)(2). Pub. L. 111–148, § 5103(a)(4), which directed amendment of ‘‘paragraph (2)’’, without specifying the subsec. to be amended, by substituting ‘‘paragraph (1)’’ for ‘‘subsection (a)’’, was executed by making the substitution in par. (2) of subsec. (e), to reflect
the probable intent of Congress.
TRANSFER OF FUNCTIONS
Pub. L. 111–148, title V, § 5103(b), Mar. 23, 2010, 124
Stat. 605, provided that: ‘‘Not later than 180 days after
the date of enactment of this Act [Mar. 23, 2010], the responsibilities and resources of the National Center for
Health Workforce Analysis, as in effect on the date before the date of enactment of this Act, shall be transferred to the National Center for Health Care Workforce Analysis established under section 761 of the Public Health Service Act [42 U.S.C. 294n], as amended by
subsection (a).’’

§ 294o. Advisory Council on Graduate Medical
Education
(a) Establishment; duties
There is established the Council on Graduate
Medical Education (in this section referred to as
the ‘‘Council’’). The Council shall—
(1) make recommendations to the Secretary
of Health and Human Services (in this section
referred to as the ‘‘Secretary’’), and to the
Committee on Labor and Human Resources of
the Senate, and the Committee on Energy and
Commerce of the House of Representatives,
with respect to—
(A) the supply and distribution of physicians in the United States;
(B) current and future shortages or excesses of physicians in medical and surgical
specialties and subspecialties;
(C) issues relating to foreign medical
school graduates;
(D) appropriate Federal policies with respect to the matters specified in subparagraphs (A), (B), and (C), including policies
concerning changes in the financing of undergraduate and graduate medical education
programs and changes in the types of medical education training in graduate medical
education programs;
(E) appropriate efforts to be carried out by
hospitals, schools of medicine, schools of osteopathic medicine, and accrediting bodies
with respect to the matters specified in subparagraphs (A), (B), and (C), including efforts for changes in undergraduate and graduate medical education programs; and
(F) deficiencies in, and needs for improvements in, existing data bases concerning the

Page 807

TITLE 42—THE PUBLIC HEALTH AND WELFARE

supply and distribution of, and postgraduate
training programs for, physicians in the
United States and steps that should be taken
to eliminate those deficiencies;
(2) encourage entities providing graduate
medical education to conduct activities to voluntarily achieve the recommendations of the
Council under paragraph (1)(E);
(3) develop, publish, and implement performance measures for programs under this subchapter, except for programs under part C or
D;
(4) develop and publish guidelines for longitudinal evaluations (as described in section
294n(d)(2) of this title) for programs under this
subchapter, except for programs under part C
or D; and
(5) recommend appropriation levels for programs under this subchapter, except for programs under part C or D.
(b) Composition
The Council shall be composed of—
(1) the Assistant Secretary for Health or the
designee of the Assistant Secretary;
(2) the Administrator of the Health Care Financing Administration;
(3) the Chief Medical Director of the Department of Veterans Affairs;
(4) 6 members appointed by the Secretary to
include representatives of practicing primary
care physicians, national and specialty physician organizations, foreign medical graduates,
and medical student and house staff associations;
(5) 4 members appointed by the Secretary to
include representatives of schools of medicine
and osteopathic medicine and public and private teaching hospitals; and
(6) 4 members appointed by the Secretary to
include representatives of health insurers,
business, and labor.
(c) Terms of appointed members
(1) In general; staggered rotation
Members of the Council appointed under
paragraphs (4), (5), and (6) of subsection (b) of
this section shall be appointed for a term of 4
years, except that the term of office of the
members first appointed shall expire, as designated by the Secretary at the time of appointment, 4 at the end of 1 year, 4 at the end
of 2 years, 3 at the end of 3 years, and 3 at the
end of 4 years.
(2) Date certain for appointment
The Secretary shall appoint the first members to the Council under paragraphs (4), (5),
and (6) of subsection (b) of this section within
60 days after October 13, 1992.
(d) Chair
The Council shall elect one of its members as
Chairman of the Council.
(e) Quorum
Nine members of the Council shall constitute
a quorum, but a lesser number may hold hearings.
(f) Vacancies
Any vacancy in the Council shall not affect its
power to function.

§ 294o

(g) Compensation
Each member of the Council who is not otherwise employed by the United States Government
shall receive compensation at a rate equal to
the daily rate prescribed for GS–18 under the
General Schedule under section 5332 of title 5 for
each day, including traveltime,1 such member is
engaged in the actual performance of duties as a
member of the Council. A member of the Council
who is an officer or employee of the United
States Government shall serve without additional compensation. All members of the Council shall be reimbursed for travel, subsistence,
and other necessary expenses incurred by them
in the performance of their duties.
(h) Certain authorities and duties
(1) Authorities
In order to carry out the provisions of this
section, the Council is authorized to—
(A) collect such information, hold such
hearings, and sit and act at such times and
places, either as a whole or by subcommittee, and request the attendance and testimony of such witnesses and the production
of such books, records, correspondence,
memoranda, papers, and documents as the
Council or such subcommittee may consider
available; and
(B) request the cooperation and assistance
of Federal departments, agencies, and instrumentalities, and such departments,
agencies, and instrumentalities are authorized to provide such cooperation and assistance.
(2) Coordination of activities
The Council shall coordinate its activities
with the activities of the Secretary under section 295k of this title. The Secretary shall, in
cooperation with the Council and pursuant to
the recommendations of the Council, take
such steps as are practicable to eliminate deficiencies in the data base established under
section 295k of this title and shall make available in its reports such comprehensive data
sets as are developed pursuant to this section.
(i) Requirement regarding reports
In the reports required under subsection (a) of
this section, the Council shall specify its activities during the period for which the report is
made.
(j) Final report
Not later than April 1, 2002, the Council shall
submit a final report under subsection (a) of this
section.
(k) Termination
The Council shall terminate September 30,
2003.
(l) Funding
Amounts otherwise appropriated under this
subchapter may be utilized by the Secretary to
support the activities of the Council.
(July 1, 1944, ch. 373, title VII, § 762, formerly
Pub. L. 102–408, title III, § 301, Oct. 13, 1992, 106
Stat. 2080, as amended Pub. L. 102–531, title III,
1 So

in original. Probably should be ‘‘travel time,’’.

§ 294p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 313(b), Oct. 27, 1992, 106 Stat. 3507; renumbered
§ 762 of act July 1, 1944, and amended Pub. L.
105–392, title I, § 104(b), Nov. 13, 1998, 112 Stat.
3552; Pub. L. 107–251, title V, § 502, Oct. 26, 2002,
116 Stat. 1664; Pub. L. 111–148, title V, § 5103(d)(3),
Mar. 23, 2010, 124 Stat. 606.)
CODIFICATION
Section was formerly set out as a note under section
295k of this title prior to renumbering by Pub. L.
105–392.
PRIOR PROVISIONS
A prior section 294o, act July 1, 1944, ch. 373, title VII,
§ 777, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2052, authorized grants and contracts for improvement of training in geriatrics, prior to the general
amendment of this part by Pub. L. 105–392.
Another prior section 294o, act July 1, 1944, ch. 373,
title VII, § 742, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 172; amended Oct. 22, 1965, Pub. L. 89–290,
§ 4(c), 79 Stat. 1057; Nov. 2, 1966, Pub. L. 89–709, § 3(e), 80
Stat. 1103; Nov. 3, 1966, Pub. L. 89–751, § 5(b), 80 Stat.
1232; Aug. 16, 1968, Pub. L. 90–490, title I, § 121(b), 82 Stat.
778; July 9, 1971, Pub. L. 92–52, § 1(a), 85 Stat. 144; Nov.
18, 1971, Pub. L. 92–157, title I, § 105(a), (f)(2), 85 Stat. 449,
451; Aug. 23, 1974, Pub. L. 93–385, § 2(a), 88 Stat. 741; Apr.
22, 1976, Pub. L. 94–278, title XI, § 1105(a), 90 Stat. 416;
Oct. 12, 1976, Pub. L. 94–484, title I, § 101(e), title IV,
§§ 404, 406(d), 90 Stat. 2244, 2267, 2268; Aug. 13, 1981, Pub.
L. 97–35, title XXVII, § 2734, 95 Stat. 920; Oct. 22, 1985,
Pub. L. 99–129, title II, § 209(g), 99 Stat. 534; Nov. 6, 1990,
Pub. L. 101–527, § 5(c), 104 Stat. 2323, provided for authorization of appropriations for purpose of making
Federal contributions into student loan funds, prior to
the general amendment of this subchapter by Pub. L.
102–408. See section 292y of this title.
A prior section 762 of act July 1, 1944, was classified
to section 295a of this title prior to repeal by Pub. L.
99–129.
Another prior section 762 of act July 1, 1944, was classified to section 295a of this title prior to the general
amendment of part D of this subchapter by Pub. L.
91–696.
AMENDMENTS
2010—Subsec. (a)(3) to (5). Pub. L. 111–148 added pars.
(3) to (5).
2002—Subsec. (k). Pub. L. 107–251 substituted ‘‘2003’’
for ‘‘2002’’.
1998—Subsec. (j). Pub. L. 105–392, § 104(b)(1), substituted ‘‘2002’’ for ‘‘1995’’.
Subsec. (k). Pub. L. 105–392, § 104(b)(2), substituted
‘‘2002’’ for ‘‘1995’’.
Subsec. (l). Pub. L. 105–392, § 104(b)(3), added subsec.
(l).
1992—Subsec. (a)(2). Pub. L. 102–531 substituted ‘‘voluntarily’’ for ‘‘voluntary’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
Reference to Chief Medical Director of Department of
Veterans Affairs deemed to refer to Under Secretary for

Page 808

Health of Department of Veterans Affairs pursuant to
section 302(e) of Pub. L. 102–405, set out as a note under
section 305 of Title 38, Veterans’ Benefits.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–531 effective immediately
after enactment of Pub. L. 102–408, see section 313(c) of
Pub. L. 102–531, set out as a note under section 292y of
this title.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
FUNDING FOR COUNCIL ON GRADUATE MEDICAL
EDUCATION
Pub. L. 111–117, div. D, title II, § 216, Dec. 16, 2009, 123
Stat. 3259, provided that: ‘‘Notwithstanding any other
provisions of law, funds made available in this Act [div.
D of Pub. L. 111–117, see Tables for classification] may
be used to continue operating the Council on Graduate
Medical Education established by section 301 of Public
Law 102–408 [now section 762 of act July 1, 1944, which
is classified to this section].’’
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 111–8, div. F, title II, § 216, Mar. 11, 2009, 123
Stat. 782.
Pub. L. 110–161, div. G, title II, § 217, Dec. 26, 2007, 121
Stat. 2187.
Pub. L. 109–149, title II, § 219, Dec. 30, 2005, 119 Stat.
2861.
Pub. L. 108–447, div. F, title II, § 218, Dec. 8, 2004, 118
Stat. 3141.
Pub. L. 108–199, div. E, title II, § 219, Jan. 23, 2004, 118
Stat. 255.

§ 294p. Pediatric rheumatology
(a) In general
The Secretary, acting through the appropriate
agencies, shall evaluate whether the number of
pediatric rheumatologists is sufficient to address the health care needs of children with arthritis and related conditions, and if the Secretary determines that the number is not sufficient, shall develop strategies to help address
the shortfall.
(b) Report to Congress
Not later than October 1, 2001, the Secretary
shall submit to the Congress a report describing
the results of the evaluation under subsection
(a) of this section, and as applicable, the strategies developed under such subsection.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title VII, § 763, as added
Pub. L. 106–310, div. A, title III, § 301(b), Oct. 17,
2000, 114 Stat. 1111.)
PRIOR PROVISIONS
A prior section 294p, act July 1, 1944, ch. 373, title VII,
§ 778, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2054, authorized grants and contracts to assist
provision of health care in rural areas, prior to the general amendment of this part by Pub. L. 105–392.

Page 809

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Another prior section 294p, act July 1, 1944, ch. 373,
title VII, § 743, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 172; amended Oct. 22, 1965, Pub. L. 89–290,
§ 4(d), 79 Stat. 1057; Nov. 3, 1966, Pub. L. 89–751, § 5(c)(2),
(3), 80 Stat. 1233; Aug. 16, 1968, Pub. L. 90–490, title I,
§ 121(c), 82 Stat. 778; July 9, 1971, Pub. L. 92–52, § 1(b), 85
Stat. 144; Nov. 18, 1971, Pub. L. 92–157, title I, § 105(e)(2),
(f)(2), 85 Stat. 451; Oct. 12, 1976, Pub. L. 94–484, title IV,
§§ 405, 406(e), 90 Stat. 2267, 2268; Aug. 13, 1981, Pub. L.
97–35, title XXVII, § 2736, 95 Stat. 920; Oct. 22, 1985, Pub.
L. 99–129, title II, § 209(i), 99 Stat. 536; Nov. 4, 1988, Pub.
L. 100–607, title VI, § 603(d), 102 Stat. 3125, related to distribution of assets from loan funds, prior to the general
amendment of this subchapter by Pub. L. 102–408. See
section 292x of this title.
A prior section 763 of act July 1, 1944, was classified
to section 294b of this title prior to the general amendment of part D of this subchapter by Pub. L. 105–392.
Another prior section 763 of act July 1, 1944, was classified to section 295b of this title prior to repeal by
Pub. L. 99–129.
Another prior section 763 of act July 1, 1944, was classified to section 295b of this title prior to the general
amendment of former part D of this subchapter by Pub.
L. 91–696.
Prior sections 294q to 294r were omitted in the general amendment of this subchapter by Pub. L. 102–408.
Section 294q, act July 1, 1944, ch. 373, title VII, § 744,
formerly § 745, as added Sept. 24, 1963, Pub. L. 88–129,
§ 2(b), 77 Stat. 173; amended Nov. 18, 1971, Pub. L. 92–157,
title I, § 105(f)(2), 85 Stat. 451; renumbered § 744, Oct. 12,
1976, Pub. L. 94–484, title IV, § 406(a)(2), 90 Stat. 2268, related to administrative provisions. See section 292u of
this title.
Section 294q–1, act July 1, 1944, ch. 373, title VII, § 745,
as added Oct. 22, 1985, Pub. L. 99–129, title II, § 209(h)(2),
99 Stat. 535, related to student loan information to be
furnished to students. See section 292v of this title.
Section 294q–2, act July 1, 1944, ch. 373, title VII, § 746,
as added Oct. 22, 1985, Pub. L. 99–129, title II, § 209(h)(2),
99 Stat. 536, related to procedures for appeal of terminations of agreements with schools. See section 292w of
this title.
Section 294q–3, act July 1, 1944, ch. 373, title VII, § 747,
formerly § 745, as added and renumbered § 747, Oct. 22,
1985, Pub. L. 99–129, title II, § 209(a)(4), (h)(1), 99 Stat.
532, 535, defined ‘‘school of pharmacy’’.
Section 294r, act July 1, 1944, ch. 373, title VII, § 751,
as added Nov. 4, 1988, Pub. L. 100–607, title VI, § 604, 102
Stat. 3126, related to establishment of a loan repayment program for allied health personnel.
Another prior section 294r, act July 1, 1944, ch. 373,
title VII, § 748, as added Oct. 12, 1976, Pub. L. 94–484,
title IV, § 408(a), 90 Stat. 2279; amended Aug. 1, 1977,
Pub. L. 95–83, title III, § 307(f), 91 Stat. 391; Dec. 19, 1977,
Pub. L. 95–215, § 3, 91 Stat. 1504; Sept. 29, 1979, Pub. L.
96–76, title II, § 206(a), 93 Stat. 583, which related to
traineeships for students in schools of public health,
was renumbered section 792 of act July 1, 1944, by Pub.
L. 97–35 and transferred to section 295h–1b of this title,
and was subsequently omitted in the general amendment of this subchapter by Pub. L. 102–408.
A prior section 294s, act July 1, 1944, ch. 373, title VII,
§ 749, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(a), 90 Stat. 2280; amended Aug. 1, 1977, Pub. L.
95–83, title III, § 307(f), 91 Stat. 391, Pub. L. 96–88, title
III, § 301(a)(1), title V, § 507, 93 Stat. 677, 692, which related to traineeships for students in other graduate programs, was renumbered section 791A of act July 1, 1944,
by Pub. L. 97–35 and transferred to section 295h–1a of
this title, and was subsequently omitted in the general
amendment of this subchapter by Pub. L. 102–408.
A prior section 294t, act July 1, 1944, ch. 373, title VII,
§ 751, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2281; amended Dec. 19, 1977, Pub. L.
95–215, § 5, 91 Stat. 1506; Nov. 9, 1978, Pub. L. 95–623,
§ 12(c), 92 Stat. 3457; Nov. 10, 1978, Pub. L. 95–626, title I,
§ 113(b), 92 Stat. 3563; July 10, 1979, Pub. L. 96–32, § 7(i),
93 Stat. 84, which related to National Health Service
Corps Scholarships Program, was renumbered section

§ 294p

338A of act July 1, 1944, by Pub. L. 97–35 and transferred
to section 254l of this title.
A prior section 294u, act July 1, 1944, ch. 373, title VII,
§ 752, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2284; amended Nov. 10, 1978, Pub. L.
95–626, title I, § 113(b), 92 Stat. 3563; Sept. 29, 1979, Pub.
L. 96–76, title II, § 202(a), (b), 93 Stat. 582, which related
to obligated service under contract, was renumbered
section 338B of act July 1, 1944, by Pub. L. 97–35 and
transferred to section 254m of this title, and subsequently renumbered section 338C of act July 1, 1944, by
Pub. L. 100–177.
A prior section 294v, act July 1, 1944, ch. 373, title VII,
§ 753, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2285; amended Dec. 17, 1980, Pub. L.
96–538, title IV, § 403, 94 Stat. 3192, which related to private practice, was renumbered section 338C of act July
1, 1944, by Pub. L. 97–35 and transferred to section 254n
of this title, and subsequently renumbered section 338D
of act July 1, 1944, by Pub. L. 100–177.
A prior section 294w, act July 1, 1944, ch. 373, title
VII, § 754, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2286; amended Aug. 1, 1977, Pub. L.
95–83, title III, § 307(g), 91 Stat. 391, which related to
breach of scholarship contract, was renumbered section
338D of act July 1, 1944, by Pub. L. 97–35 and transferred
to section 254o of this title, and subsequently renumbered section 338E of act July 1, 1944, by Pub. L. 100–177.
A prior section 294x, act July 1, 1944, ch. 373, title VII,
§ 755, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2287, which related to special grants
for former Corps member to enter private practice, was
renumbered section 338E of act July 1, 1944, by Pub. L.
97–35 and transferred to section 254p of this title, and
subsequently renumbered section 338F of act July 1,
1944, by Pub. L. 100–177, and section 338G of act July 1,
1944, by Pub. L. 101–597.
A prior section 294y, act July 1, 1944, ch. 373, title VII,
§ 756, as added Oct. 12, 1976, Pub. L. 94–484, title IV,
§ 408(b)(1), 90 Stat. 2288, which related to authorization
of appropriations, was renumbered section 338F of act
July 1, 1944, by Pub. L. 97–35 and transferred to section
254q of this title, and subsequently renumbered section
338G of act July 1, 1944, prior to repeal by Pub. L.
100–177, title II, §§ 201(2), 203, Dec. 1, 1987, 101 Stat. 992,
999.
A prior section 294y–1, act July 1, 1944, ch. 373, title
VII, § 757, as added Aug. 1, 1977, Pub. L. 95–83, title III,
§ 307(n)(1), 91 Stat. 392; amended Dec. 17, 1980, Pub. L.
96–537, § 3(d), 94 Stat. 3174, which related to Indian
Health Scholarships, was renumbered section 338G of
act July 1, 1944, by Pub. L. 97–35 and transferred to section 254r of this title, and subsequently renumbered
section 338I of act July 1, 1944, by Pub. L. 100–177, prior
to repeal by Pub. L. 100–713, title I, § 104(b)(1), Nov. 23,
1988, 102 Stat. 4787.
Prior sections 294z to 294cc were omitted in the general amendment of this subchapter by Pub. L. 102–408.
Section 294z, act July 1, 1944, ch. 373, title VII, § 758,
as added Oct. 12, 1976, Pub. L. 94–484, title IV, § 408(c), 90
Stat. 2289; amended Aug. 1, 1977, Pub. L. 95–83, title III,
§ 307(h), 91 Stat. 391; Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2737, 95 Stat. 920; Oct. 22, 1985, Pub. L. 99–129,
title I, § 102, title II, § 210(a), 99 Stat. 523, 537; Nov. 4,
1988, Pub. L. 100–607, title VI, §§ 605, 628(9), 629(b)(2), 102
Stat. 3126, 3146, related to scholarships for students of
exceptional financial need.
Section 294aa, act July 1, 1944, ch. 373, title VII, § 759,
as added Oct. 12, 1976, Pub. L. 94–484, title IV, § 408(c), 90
Stat. 2289; amended Nov. 16, 1990, Pub. L. 101–597, title
IV, § 401(b)[(a)], 104 Stat. 3035, established a Lister Hill
scholarship program of grants for family practice of
medicine.
Section 294bb, act July 1, 1944, ch. 373, title VII, § 760,
as added Nov. 6, 1990, Pub. L. 101–527, § 6, 104 Stat. 2323,
related to grants and other assistance for students
from disadvantaged backgrounds. See section 293a of
this title.
Section 294cc, act July 1, 1944, ch. 373, title VII, § 761,
as added Nov. 6, 1990, Pub. L. 101–527, § 6, 104 Stat. 2325,

§ 294q

TITLE 42—THE PUBLIC HEALTH AND WELFARE

related to a loan repayment program regarding service
on faculties of certain health professions schools. See
section 293b of this title.

§ 294q. National Health Care Workforce Commission
(a) Purpose
It is the purpose of this section to establish a
National Health Care Workforce Commission
that—
(1) serves as a national resource for Congress, the President, States, and localities;
(2) communicates and coordinates with the
Departments of Health and Human Services,
Labor, Veterans Affairs, Homeland Security,
and Education on related activities administered by one or more of such Departments;
(3) develops and commissions evaluations of
education and training activities to determine
whether the demand for health care workers is
being met;
(4) identifies barriers to improved coordination at the Federal, State, and local levels and
recommend ways to address such barriers; and
(5) encourages innovations to address population needs, constant changes in technology,
and other environmental factors.
(b) Establishment
There is hereby established the National
Health Care Workforce Commission (in this section referred to as the ‘‘Commission’’).
(c) Membership
(1) Number and appointment
The Commission shall be composed of 15
members to be appointed by the Comptroller
General, without regard to section 5 of the
Federal Advisory Committee Act (5 U.S.C.
App.).
(2) Qualifications
(A) In general
The membership of the Commission shall
include individuals—
(i) with national recognition for their expertise in health care labor market analysis, including health care workforce analysis; health care finance and economics;
health care facility management; health
care plans and integrated delivery systems; health care workforce education and
training; health care philanthropy; providers of health care services; and other related fields; and
(ii) who will provide a combination of
professional
perspectives,
broad
geographic representation, and a balance between urban, suburban, rural, and frontier
representatives.
(B) Inclusion
(i) In general
The membership of the Commission shall
include no less than one representative
of—
(I) the health care workforce and
health professionals;
(II) employers, including representatives of small business and self-employed
individuals;

Page 810

(III) third-party payers;
(IV) individuals skilled in the conduct
and interpretation of health care services and health economics research;
(V) representatives of consumers;
(VI) labor unions;
(VII) State or local workforce investment boards; and
(VIII) educational institutions (which
may include elementary and secondary
institutions, institutions of higher education, including 2 and 4 year institutions, or registered apprenticeship programs).
(ii) Additional members
The remaining membership may include
additional representatives from clause (i)
and other individuals as determined appropriate by the Comptroller General of the
United States.
(C) Majority non-providers
Individuals who are directly involved in
health professions education or practice
shall not constitute a majority of the membership of the Commission.
(D) Ethical disclosure
The Comptroller General shall establish a
system for public disclosure by members of
the Commission of financial and other potential conflicts of interest relating to such
members. Members of the Commission shall
be treated as employees of Congress for purposes of applying title I of the Ethics in Government Act of 1978 [5 U.S.C. App.]. Members
of the Commission shall not be treated as
special government employees under title 18.
(3) Terms
(A) In general
The terms of members of the Commission
shall be for 3 years except that the Comptroller General shall designate staggered
terms for the members first appointed.
(B) Vacancies
Any member appointed to fill a vacancy
occurring before the expiration of the term
for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve
after the expiration of that member’s term
until a successor has taken office. A vacancy
in the Commission shall be filled in the manner in which the original appointment was
made.
(C) Initial appointments
The Comptroller General shall make initial appointments of members to the Commission not later than September 30, 2010.
(4) Compensation
While serving on the business of the Commission (including travel time), a member of
the Commission shall be entitled to compensation at the per diem equivalent of the rate
provided for level IV of the Executive Schedule under section 5315 of tile 1 5, and while so
1 So

in original. Probably should be ‘‘title’’.

Page 811

TITLE 42—THE PUBLIC HEALTH AND WELFARE

serving away from home and the member’s
regular place of business, a member may be allowed travel expenses, as authorized by the
Chairman of the Commission. Physicians serving as personnel of the Commission may be
provided a physician comparability allowance
by the Commission in the same manner as
Government physicians may be provided such
an allowance by an agency under section 5948
of title 5, and for such purpose subsection (i) of
such section shall apply to the Commission in
the same manner as it applies to the Tennessee Valley Authority. For purposes of pay
(other than pay of members of the Commission) and employment benefits, rights, and
privileges, all personnel of the Commission
shall be treated as if they were employees of
the United States Senate. Personnel of the
Commission shall not be treated as employees
of the Government Accountability Office for
any purpose.
(5) Chairman, Vice Chairman
The Comptroller General shall designate a
member of the Commission, at the time of appointment of the member, as Chairman and a
member as Vice Chairman for that term of appointment, except that in the case of vacancy
of the chairmanship or vice chairmanship, the
Comptroller General may designate another
member for the remainder of that member’s
term.
(6) Meetings
The Commission shall meet at the call of the
chairman, but no less frequently than on a
quarterly basis.
(d) Duties
(1) Recognition, dissemination, and communication
The Commission shall—
(A) recognize efforts of Federal, State, and
local partnerships to develop and offer
health care career pathways of proven effectiveness;
(B) disseminate information on promising
retention practices for health care professionals; and
(C) communicate information on important policies and practices that affect the recruitment, education and training, and retention of the health care workforce.
(2) Review of health care workforce and annual reports
In order to develop a fiscally sustainable integrated workforce that supports a high-quality, readily accessible health care delivery
system that meets the needs of patients and
populations, the Commission, in consultation
with relevant Federal, State, and local agencies, shall—
(A) review current and projected health
care workforce supply and demand, including the topics described in paragraph (3);
(B) make recommendations to Congress
and the Administration concerning national
health care workforce priorities, goals, and
policies;
(C) by not later than October 1 of each
year (beginning with 2011), submit a report

§ 294q

to Congress and the Administration containing the results of such reviews and recommendations concerning related policies; and
(D) by not later than April 1 of each year
(beginning with 2011), submit a report to
Congress and the Administration containing
a review of, and recommendations on, at a
minimum one high priority area as described
in paragraph (4).
(3) Specific topics to be reviewed
The topics described in this paragraph include—
(A) current health care workforce supply
and distribution, including demographics,
skill sets, and demands, with projected demands during the subsequent 10 and 25 year
periods;
(B) health care workforce education and
training capacity, including the number of
students who have completed education and
training, including registered apprenticeships; the number of qualified faculty; the
education and training infrastructure; and
the education and training demands, with
projected demands during the subsequent 10
and 25 year periods;
(C) the education loan and grant programs
in titles VII and VIII of the Public Health
Service Act (42 U.S.C. 292 et seq. and 296 et
seq.), with recommendations on whether
such programs should become part of the
Higher Education Act of 1965 (20 U.S.C. 1001
et seq[., 42 U.S.C. 2751 et seq.]);
(D) the implications of new and existing
Federal policies which affect the health care
workforce, including Medicare and Medicaid
graduate medical education policies, titles
VII and VIII of the Public Health Service
Act (42 U.S.C. 292 et seq. and 296 et seq.), the
National Health Service Corps (with recommendations for aligning such programs with
national health workforce priorities and
goals), and other health care workforce programs, including those supported through
the Workforce Investment Act of 1998 (29
U.S.C. 2801 et seq.), the Carl D. Perkins Career and Technical Education Act of 2006 (20
U.S.C. 2301 et seq.), the Higher Education
Act of 1965 (20 U.S.C. 1001 et seq.[, 42 U.S.C.
2751 et seq.]), and any other Federal health
care workforce programs;
(E) the health care workforce needs of special populations, such as minorities, rural
populations, medically underserved populations, gender specific needs, individuals
with disabilities, and geriatric and pediatric
populations with recommendations for new
and existing Federal policies to meet the
needs of these special populations; and
(F) recommendations creating or revising
national loan repayment programs and
scholarship programs to require low-income,
minority medical students to serve in their
home communities, if designated as medical
underserved community.2
2 So

in original.

§ 294q

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) High priority areas
(A) In general
The initial high priority topics described
in this paragraph include each of the following:
(i) Integrated health care workforce
planning that identifies health care professional skills needed and maximizes the
skill sets of health care professionals
across disciplines.
(ii) An analysis of the nature, scopes of
practice, and demands for health care
workers in the enhanced information technology and management workplace.
(iii) An analysis of how to align Medicare and Medicaid graduate medical education policies with national workforce
goals.
(iv) An analysis of, and recommendations for, eliminating the barriers to entering and staying in primary care, including provider compensation.
(v) The education and training capacity,
projected demands, and integration with
the health care delivery system of each of
the following:
(I) Nursing workforce capacity at all
levels.
(II) Oral health care workforce capacity at all levels.
(III) Mental and behavioral health care
workforce capacity at all levels.
(IV) Allied health and public health
care workforce capacity at all levels.
(V) Emergency medical service workforce capacity, including the retention
and recruitment of the volunteer workforce, at all levels.
(VI) The geographic distribution of
health care providers as compared to the
identified health care workforce needs of
States and regions.
(B) Future determinations
The Commission may require that additional topics be included under subparagraph
(A). The appropriate committees of Congress
may recommend to the Commission the inclusion of other topics for health care workforce development areas that require special
attention.
(5) Grant program
The Commission shall—
(A) review implementation progress reports on, and report to Congress about, the
State Health Care Workforce Development
Grant program established in section 294r of
this title;
(B) in collaboration with the Department
of Labor and in coordination with the Department of Education and other relevant
Federal agencies, make recommendations to
the fiscal and administrative agent under
section 294r(b) of this title for grant recipients under section 294r of this title;
(C) assess the implementation of the
grants under such section; and
(D) collect performance and report information, including identified models and best
practices, on grants from the fiscal and ad-

Page 812

ministrative agent under such section and
distribute this information to Congress, relevant Federal agencies, and to the public.
(6) Study
The Commission shall study effective mechanisms for financing education and training
for careers in health care, including public
health and allied health.
(7) Recommendations
The Commission shall submit recommendations to Congress, the Department of Labor,
and the Department of Health and Human
Services about improving safety, health, and
worker protections in the workplace for the
health care workforce.
(8) Assessment
The Commission shall assess and receive reports from the National Center for Health
Care Workforce Analysis established under
section 761(b) of the Public Service Health Act
[42 U.S.C. 294n(b)] (as amended by section
5103).3
(e) Consultation with Federal, State, and local
agencies, Congress, and other organizations
(1) In general
The Commission shall consult with Federal
agencies (including the Departments of Health
and Human Services, Labor, Education, Commerce, Agriculture, Defense, and Veterans Affairs and the Environmental Protection Agency), Congress, the Medicare Payment Advisory
Commission, the Medicaid and CHIP Payment
and Access Commission, and, to the extent
practicable, with State and local agencies, Indian tribes, voluntary health care organizations, professional societies, and other relevant public-private health care partnerships.
(2) Obtaining official data
The Commission, consistent with established privacy rules, may secure directly from
any department or agency of the Executive
Branch information necessary to enable the
Commission to carry out this section.
(3) Detail of Federal Government employees
An employee of the Federal Government
may be detailed to the Commission without
reimbursement. The detail of such an employee shall be without interruption or loss of
civil service status.
(f) Director and staff; experts and consultants
Subject to such review as the Comptroller
General of the United States determines to be
necessary to ensure the efficient administration
of the Commission, the Commission may—
(1) employ and fix the compensation of an
executive director that shall not exceed the
rate of basic pay payable for level V of the Executive Schedule and such other personnel as
may be necessary to carry out its duties (without regard to the provisions of title 5 governing appointments in the competitive service);
(2) seek such assistance and support as may
be required in the performance of its duties
from appropriate Federal departments and
agencies;
3 See

References in Text note below.

Page 813

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) enter into contracts or make other arrangements, as may be necessary for the conduct of the work of the Commission (without
regard to section 6101 of title 41);
(4) make advance, progress, and other payments which relate to the work of the Commission;
(5) provide transportation and subsistence
for persons serving without compensation; and
(6) prescribe such rules and regulations as
the Commission determines to be necessary
with respect to the internal organization and
operation of the Commission.
(g) Powers
(1) Data collection
In order to carry out its functions under this
section, the Commission shall—
(A) utilize existing information, both published and unpublished, where possible, collected and assessed either by its own staff or
under other arrangements made in accordance with this section, including coordination with the Bureau of Labor Statistics;
(B) carry out, or award grants or contracts
for the carrying out of, original research and
development, where existing information is
inadequate, and
(C) adopt procedures allowing interested
parties to submit information for the Commission’s use in making reports and recommendations.
(2) Access of the Government Accountability
Office to information
The Comptroller General of the United
States shall have unrestricted access to all deliberations, records, and data of the Commission, immediately upon request.
(3) Periodic audit
The Commission shall be subject to periodic
audit by an independent public accountant
under contract to the Commission.
(h) Authorization of appropriations
(1) Request for appropriations
The Commission shall submit requests for
appropriations in the same manner as the
Comptroller General of the United States submits requests for appropriations. Amounts so
appropriated for the Commission shall be separate from amounts appropriated for the Comptroller General.
(2) Authorization
There are authorized to be appropriated such
sums as may be necessary to carry out this
section.
(3) Gifts and services
The Commission may not accept gifts, bequeaths, or donations of property, but may accept and use donations of services for purposes
of carrying out this section.
(i) Definitions
In this section:
(1) Health care workforce
The term ‘‘health care workforce’’ includes
all health care providers with direct patient
care and support responsibilities, such as phy-

§ 294q

sicians, nurses, nurse practitioners, primary
care providers, preventive medicine physicians, optometrists, ophthalmologists, physician assistants, pharmacists, dentists, dental
hygienists, and other oral healthcare professionals, allied health professionals, doctors of
chiropractic, community health workers,
health care paraprofessionals, direct care
workers, psychologists and other behavioral
and mental health professionals (including
substance abuse prevention and treatment
providers), social workers, physical and occupational therapists, certified nurse midwives,
podiatrists, the EMS workforce (including professional and volunteer ambulance personnel
and firefighters who perform emergency medical services), licensed complementary and alternative medicine providers, integrative
health practitioners, public health professionals, and any other health professional that
the Comptroller General of the United States
determines appropriate.
(2) Health professionals
The term ‘‘health professionals’’ includes—
(A) dentists, dental hygienists, primary
care providers, specialty physicians, nurses,
nurse practitioners, physician assistants,
psychologists and other behavioral and mental health professionals (including substance
abuse prevention and treatment providers),
social workers, physical and occupational
therapists, optometrists, ophthalmologists,4
public health professionals, clinical pharmacists, allied health professionals, doctors
of chiropractic, community health workers,
school nurses, certified nurse midwives, podiatrists, licensed complementary and alternative medicine providers, the EMS workforce (including professional and volunteer
ambulance personnel and firefighters who
perform emergency medical services), and
integrative health practitioners;
(B) national representatives of health professionals;
(C) representatives of schools of medicine,
osteopathy, nursing, dentistry, optometry,
pharmacy, chiropractic, allied health, educational programs for public health professionals, behavioral and mental health professionals (as so defined), social workers,
pharmacists, physical and occupational
therapists, optometrists, ophthalmologists,4
oral health care industry dentistry and dental hygiene, and physician assistants;
(D) representatives of public and private
teaching hospitals, and ambulatory health
facilities, including Federal medical facilities; and
(E) any other health professional the
Comptroller General of the United States determines appropriate.
(Pub. L. 111–148, title V, § 5101, title X, § 10501(a),
Mar. 23, 2010, 124 Stat. 592, 993.)
REFERENCES IN TEXT
Section 5 of the Federal Advisory Committee Act, referred to in subsec. (c)(1), is section 5 of Pub. L. 92–463,
which is set out in the Appendix to Title 5, Government
Organization and Employees.
4 See

2010 Amendment note below.

§ 294q

TITLE 42—THE PUBLIC HEALTH AND WELFARE

The Ethics in Government Act of 1978, referred to in
subsec. (c)(2)(D), is Pub. L. 95–521, Oct. 26, 1978, 92 Stat.
1824. Title I of the Act is set out in the Appendix to
Title 5, Government Organization and Employees. For
complete classification of this Act to the Code, see
Short Title note set out under section 101 of Pub. L.
95–521 in the Appendix to Title 5 and Tables.
The Public Health Service Act, referred to in subsec.
(d)(3)(C), (D), is act July 1, 1944, ch. 373, 58 Stat. 682.
Titles VII and VIII of the Act are classified generally
to this subchapter and subchapter VI (§ 296 et seq.) of
this chapter, respectively. For complete classification
of this Act to the Code, see Short Title note set out
under section 201 of this title and Tables.
The Higher Education Act of 1965, referred to in subsec. (d)(3)(C), (D), is Pub. L. 89–329, Nov. 8, 1965, 79 Stat.
1219, which is classified principally to chapter 28 (§ 1001
et seq.) of Title 20, Education, and part C (§ 2751 et seq.)
of subchapter I of chapter 34 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 1001 of Title 20 and Tables.
The Workforce Investment Act of 1998 (29 U.S.C. 2801
et seq.), referred to in subsec. (d)(3)(D), is Pub. L.
105–220, Aug. 7, 1998, 112 Stat. 936. Title I of the Act is
classified principally to chapter 30 (§ 2801 et seq.) of
Title 29, Labor. For complete classification of this Act
to the Code, see Short Title note set out under section
9201 of Title 20, Education, and Tables.
The Carl D. Perkins Career and Technical Education
Act of 2006, referred to in subsec. (d)(3)(D), is Pub. L.
88–210, Dec. 18, 1963, 77 Stat. 403, as amended generally
by Pub. L. 109–270, § 1(b), Aug. 12, 2006, 120 Stat. 683,
which is classified generally to chapter 44 (§ 2301 et seq.)
of Title 20, Education. For complete classification of
this Act to the Code, see Short Title note set out under
section 2301 of Title 20 and Tables.
Section 5103, referred to in subsec. (d)(8), means section 5103 of Pub. L. 111–148.
Level V of the Executive Schedule, referred to in subsec. (f)(1), is set out in section 5316 of Title 5, Government Organization and Employees.
CODIFICATION
In subsec. (f)(3), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec.
(c)(2)(B)(i)(II).
Pub.
L.
111–148,
§ 10501(a)(1), inserted ‘‘, including representatives of
small business and self-employed individuals’’ after
‘‘employers’’.
Subsec. (d)(4)(A)(iv), (v). Pub. L. 111–148, § 10501(a)(2),
added cl. (iv) and redesignated former cl. (iv) as (v).
Subsec. (i)(2)(A), (C). Pub. L. 111–148, § 10501(a)(3),
which directed insertion of ‘‘optometrists, ophthalmologists,’’ after ‘‘occupational therapists,’’ in subpar. (B)
of subsec. (i)(2), was executed by making the insertion
in subpars. (A) and (C). The words ‘‘occupational therapists,’’ do not appear in subpar. (B).
PURPOSE
Pub. L. 111–148, title V, § 5001, Mar. 23, 2010, 124 Stat.
588, provided that: ‘‘The purpose of this title [see
Tables for classification] is to improve access to and
the delivery of health care services for all individuals,
particularly low income, underserved, uninsured, minority, health disparity, and rural populations by—
‘‘(1) gathering and assessing comprehensive data in
order for the health care workforce to meet the
health care needs of individuals, including research
on the supply, demand, distribution, diversity, and
skills needs of the health care workforce;
‘‘(2) increasing the supply of a qualified health care
workforce to improve access to and the delivery of
health care services for all individuals;

Page 814

‘‘(3) enhancing health care workforce education and
training to improve access to and the delivery of
health care services for all individuals; and
‘‘(4) providing support to the existing health care
workforce to improve access to and the delivery of
health care services for all individuals.’’
DEFINITIONS
Pub. L. 111–148, title V, § 5002(a), Mar. 23, 2010, 124
Stat. 588, provided that: ‘‘In this title [see Tables for
classification]:
‘‘(1) ALLIED HEALTH PROFESSIONAL.—The term ‘allied health professional’ means an allied health professional as defined in section 799B(5) of the Public
Heath Service Act (42 U.S.C. 295p(5)) who—
‘‘(A) has graduated and received an allied health
professions degree or certificate from an institution
of higher education; and
‘‘(B) is employed with a Federal, State, local or
tribal public health agency, or in a setting where
patients might require health care services, including acute care facilities, ambulatory care facilities,
personal residences, and other settings located in
health professional shortage areas, medically underserved areas, or medically underserved populations, as recognized by the Secretary of Health
and Human Services.
‘‘(2) HEALTH CARE CAREER PATHWAY.—The term
‘healthcare career pathway’ means a rigorous, engaging, and high quality set of courses and services
that—
‘‘(A) includes an articulated sequence of academic
and career courses, including 21st century skills;
‘‘(B) is aligned with the needs of healthcare industries in a region or State;
‘‘(C) prepares students for entry into the full
range of postsecondary education options, including
registered apprenticeships, and careers;
‘‘(D) provides academic and career counseling in
student-to-counselor ratios that allow students to
make informed decisions about academic and career options;
‘‘(E) meets State academic standards, State requirements for secondary school graduation and is
aligned with requirements for entry into postsecondary education, and applicable industry standards; and
‘‘(F) leads to 2 or more credentials, including—
‘‘(i) a secondary school diploma; and
‘‘(ii) a postsecondary degree, an apprenticeship
or other occupational certification, a certificate,
or a license.
‘‘(3) INSTITUTION OF HIGHER EDUCATION.—The term
‘institution of higher education’ has the meaning
given the term in sections 101 and 102 of the Higher
Education Act of 1965 (20 U.S.C. 1001 and 1002).
‘‘(4) LOW INCOME INDIVIDUAL, STATE WORKFORCE INVESTMENT BOARD, AND LOCAL WORKFORCE INVESTMENT
BOARD.—
‘‘(A) LOW-INCOME INDIVIDUAL.—The term ‘low-income individual’ has the meaning given that term
in section 101 of the Workforce investment [sic] Act
of 1998 (29 U.S.C. 2801).
‘‘(B) STATE WORKFORCE INVESTMENT BOARD; LOCAL
WORKFORCE INVESTMENT BOARD.—The terms ‘State
workforce investment board’ and ‘local workforce
investment board’, [sic] refer to a State workforce
investment board established under section 111 of
the Workforce Investment Act of 1998 (29 U.S.C.
2821) and a local workforce investment board established under section 117 of such Act (29 U.S.C. 2832),
respectively.
‘‘(5) POSTSECONDARY EDUCATION.—The term ‘postsecondary education’ means—
‘‘(A) a 4-year program of instruction, or not less
than a 1-year program of instruction that is acceptable for credit toward an associate or a baccalaureate degree, offered by an institution of higher
education; or
‘‘(B) a certificate or registered apprenticeship
program at the postsecondary level offered by an

Page 815

TITLE 42—THE PUBLIC HEALTH AND WELFARE

institution of higher education or a non-profit educational institution.
‘‘(6) REGISTERED APPRENTICESHIP PROGRAM.—The
term ‘registered apprenticeship program’ means an
industry skills training program at the postsecondary level that combines technical and theoretical
training through structure on the job learning with
related instruction (in a classroom or through distance learning) while an individual is employed,
working under the direction of qualified personnel or
a mentor, and earning incremental wage increases
aligned to enhance job proficiency, resulting in the
acquisition of a nationally recognized and portable
certificate, under a plan approved by the Office of Apprenticeship or a State agency recognized by the Department of Labor.’’

§ 294r. State health care workforce development
grants
(a) Establishment
There is established a competitive health care
workforce development grant program (referred
to in this section as the ‘‘program’’) for the purpose of enabling State partnerships to complete
comprehensive planning and to carry out activities leading to coherent and comprehensive
health care workforce development strategies at
the State and local levels.
(b) Fiscal and administrative agent
The Health Resources and Services Administration of the Department of Health and Human
Services (referred to in this section as the ‘‘Administration’’) shall be the fiscal and administrative agent for the grants awarded under this
section. The Administration is authorized to
carry out the program, in consultation with the
National Health Care Workforce Commission
(referred to in this section as the ‘‘Commission’’), which shall review reports on the development, implementation, and evaluation activities of the grant program, including—
(1) administering the grants;
(2) providing technical assistance to grantees; and
(3) reporting performance information to the
Commission.
(c) Planning grants
(1) Amount and duration
A planning grant shall be awarded under this
subsection for a period of not more than one
year and the maximum award may not be
more than $150,000.
(2) Eligibility
To be eligible to receive a planning grant, an
entity shall be an eligible partnership. An eligible partnership shall be a State workforce
investment board, if it includes or modifies
the members to include at least one representative from each of the following: health care
employer, labor organization, a public 2-year
institution of higher education, a public 4-year
institution of higher education, the recognized
State federation of labor, the State public secondary education agency, the State P–16 or
P–20 Council if such a council exists, and a
philanthropic organization that is actively engaged in providing learning, mentoring, and
work opportunities to recruit, educate, and
train individuals for, and retain individuals in,
careers in health care and related industries.

§ 294r

(3) Fiscal and administrative agent
The Governor of the State receiving a planning grant has the authority to appoint a fiscal and an administrative agency for the partnership.
(4) Application
Each State partnership desiring a planning
grant shall submit an application to the Administrator of the Administration at such
time and in such manner, and accompanied by
such information as the Administrator may
reasonable 1 require. Each application submitted for a planning grant shall describe the
members of the State partnership, the activities for which assistance is sought, the proposed performance benchmarks to be used to
measure progress under the planning grant, a
budget for use of the funds to complete the required activities described in paragraph (5),
and such additional assurance and information
as the Administrator determines to be essential to ensure compliance with the grant program requirements.
(5) Required activities
A State partnership receiving a planning
grant shall carry out the following:
(A) Analyze State labor market information in order to create health care career
pathways for students and adults, including
dislocated workers.
(B) Identify current and projected high demand State or regional health care sectors
for purposes of planning career pathways.
(C) Identify existing Federal, State, and
private resources to recruit, educate or
train, and retain a skilled health care workforce and strengthen partnerships.
(D) Describe the academic and health care
industry skill standards for high school
graduation, for entry into postsecondary
education, and for various credentials and licensure.
(E) Describe State secondary and postsecondary education and training policies,
models, or practices for the health care sector, including career information and guidance counseling.
(F) Identify Federal or State policies or
rules to developing 2 a coherent and comprehensive health care workforce development
strategy and barriers and a plan to resolve
these barriers.
(G) Participate in the Administration’s
evaluation and reporting activities.
(6) Performance and evaluation
Before the State partnership receives a planning grant, such partnership and the Administrator of the Administration shall jointly determine the performance benchmarks that
will be established for the purposes of the
planning grant.
(7) Match
Each State partnership receiving a planning
grant shall provide an amount, in cash or in
kind, that is not less that 15 percent of the
1 So
2 So

in original. Probably should be ‘‘reasonably’’.
in original. Probably should be ‘‘develop’’.

§ 294r

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amount of the grant, to carry out the activities supported by the grant. The matching requirement may be provided from funds available under other Federal, State, local or private sources to carry out the activities.
(8) Report
(A) Report to administration
Not later than 1 year after a State partnership receives a planning grant, the partnership shall submit a report to the Administration on the State’s performance of the
activities under the grant, including the use
of funds, including matching funds, to carry
out required activities, and a description of
the progress of the State workforce investment board in meeting the performance
benchmarks.
(B) Report to Congress
The Administration shall submit a report
to Congress analyzing the planning activities, performance, and fund utilization of
each State grant recipient, including an
identification of promising practices and a
profile of the activities of each State grant
recipient.
(d) Implementation grants
(1) In general
The Administration shall—
(A) competitively award implementation
grants to State partnerships to enable such
partnerships to implement activities that
will result in a coherent and comprehensive
plan for health workforce development that
will address current and projected workforce
demands within the State; and
(B) inform the Commission and Congress
about the awards made.
(2) Duration
An implementation grant shall be awarded
for a period of no more than 2 years, except in
those cases where the Administration determines that the grantee is high performing and
the activities supported by the grant warrant
up to 1 additional year of funding.
(3) Eligibility
To be eligible for an implementation grant,
a State partnership shall have—
(A) received a planning grant under subsection (c) and completed all requirements
of such grant; or
(B) completed a satisfactory application,
including a plan to coordinate with required
partners and complete the required activities during the 2 year period of the implementation grant.
(4) Fiscal and administrative agent
A State partnership receiving an implementation grant shall appoint a fiscal and an administration agent for the implementation of
such grant.
(5) Application
Each eligible State partnership desiring an
implementation grant shall submit an application to the Administration at such time, in
such manner, and accompanied by such information as the Administration may reasonably

Page 816

require. Each application submitted shall include—
(A) a description of the members of the
State partnership;
(B) a description of how the State partnership completed the required activities under
the planning grant, if applicable;
(C) a description of the activities for which
implementation grant funds are sought, including grants to regions by the State partnership to advance coherent and comprehensive regional health care workforce planning
activities;
(D) a description of how the State partnership will coordinate with required partners
and complete the required partnership activities during the duration of an implementation grant;
(E) a budget proposal of the cost of the activities supported by the implementation
grant and a timeline for the provision of
matching funds required;
(F) proposed performance benchmarks to
be used to assess and evaluate the progress
of the partnership activities;
(G) a description of how the State partnership will collect data to report progress in
grant activities; and
(H) such additional assurances as the Administration determines to be essential to
ensure compliance with grant requirements.
(6) Required activities
(A) In general
A State partnership that receives an implementation grant may reserve not less
than 60 percent of the grant funds to make
grants to be competitively awarded by the
State partnership, consistent with State
procurement rules, to encourage regional
partnerships to address health care workforce development needs and to promote innovative health care workforce career pathway activities, including career counseling,
learning, and employment.
(B) Eligible partnership duties
An eligible State partnership receiving an
implementation grant shall—
(i) identify and convene regional leadership to discuss opportunities to engage in
statewide health care workforce development planning, including the potential use
of competitive grants to improve the development, distribution, and diversity of
the regional health care workforce; the
alignment of curricula for health care careers; and the access to quality career information and guidance and education and
training opportunities;
(ii) in consultation with key stakeholders and regional leaders, take appropriate
steps to reduce Federal, State, or local
barriers to a comprehensive and coherent
strategy, including changes in State or
local policies to foster coherent and comprehensive health care workforce development activities, including health care career pathways at the regional and State
levels, career planning information, retraining for dislocated workers, and as ap-

Page 817

TITLE 42—THE PUBLIC HEALTH AND WELFARE

propriate, requests for Federal program or
administrative waivers;
(iii) develop, disseminate, and review
with key stakeholders a preliminary statewide strategy that addresses short- and
long-term health care workforce development supply versus demand;
(iv) convene State partnership members
on a regular basis, and at least on a semiannual basis;
(v) assist leaders at the regional level to
form partnerships, including technical assistance and capacity building activities;
(vi) collect and assess data on and report
on the performance benchmarks selected
by the State partnership and the Administration for implementation activities carried out by regional and State partnerships; and
(vii) participate in the Administration’s
evaluation and reporting activities.
(7) Performance and evaluation
Before the State partnership receives an implementation grant, it and the Administrator
shall jointly determine the performance
benchmarks that shall be established for the
purposes of the implementation grant.
(8) Match
Each State partnership receiving an implementation grant shall provide an amount, in
cash or in kind that is not less than 25 percent
of the amount of the grant, to carry out the
activities supported by the grant. The matching funds may be provided from funds available from other Federal, State, local, or private sources to carry out such activities.
(9) Reports
(A) Report to administration
For each year of the implementation
grant, the State partnership receiving the
implementation grant shall submit a report
to the Administration on the performance of
the State of the grant activities, including a
description of the use of the funds, including
matched funds, to complete activities, and a
description of the performance of the State
partnership in meeting the performance
benchmarks.
(B) Report to Congress
The Administration shall submit a report
to Congress analyzing implementation activities, performance, and fund utilization of
the State grantees, including an identification of promising practices and a profile of
the activities of each State grantee.
(e) Authorization for appropriations
(1) Planning grants
There are authorized to be appropriated to
award planning grants under subsection (c)
$8,000,000 for fiscal year 2010, and such sums as
may be necessary for each subsequent fiscal
year.
(2) Implementation grants
There are authorized to be appropriated to
award implementation grants under subsection (d), $150,000,000 for fiscal year 2010, and

§ 295

such sums as may be necessary for each subsequent fiscal year.
(Pub. L. 111–148, title V, § 5102, Mar. 23, 2010, 124
Stat. 599.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
DEFINITIONS
For definitions of terms used in this section, see section 5002(a) of Pub. L. 111–148, set out as a note under
section 294q of this title.
SUBPART 2—PUBLIC HEALTH WORKFORCE

§ 295. General provisions
(a) In general
The Secretary may award grants or contracts
to eligible entities to increase the number of individuals in the public health workforce, to enhance the quality of such workforce, and to enhance the ability of the workforce to meet national, State, and local health care needs.
(b) Eligibility
To be eligible to receive a grant or contract
under subsection (a) of this section an entity
shall—
(1) be—
(A) a health professions school, including
an accredited school or program of public
health, health administration, preventive
medicine, or dental public health or a school
providing health management programs;
(B) an academic health center;
(C) a State or local government; or
(D) any other appropriate public or private
nonprofit entity; and
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary
may require.
(c) Preference
In awarding grants or contracts under this
section the Secretary may grant a preference to
entities—
(1) serving individuals who are from disadvantaged backgrounds (including underrepresented racial and ethnic minorities); and
(2) graduating large proportions of individuals who serve in underserved communities.
(d) Activities
Amounts provided under a grant or contract
awarded under this section may be used for—
(1) the costs of planning, developing, or operating demonstration training programs;
(2) faculty development;
(3) trainee support;
(4) technical assistance;
(5) to meet the costs of projects—
(A) to plan and develop new residency
training programs and to maintain or improve existing residency training programs
in preventive medicine and dental public
health, that have available full-time faculty
members with training and experience in the
fields of preventive medicine and dental public health; and

§ 295a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) to provide financial assistance to residency trainees enrolled in such programs;
(6) the retraining of existing public health
workers as well as for increasing the supply of
new practitioners to address priority public
health, preventive medicine, public health
dentistry, and health administration needs;
(7) preparing public health professionals for
employment at the State and community levels;
(8) public health workforce loan repayment
programs; or
(9) other activities that may produce outcomes that are consistent with the purposes of
this section.
(e) Traineeships
(1) In general
With respect to amounts used under this section for the training of health professionals,
such training programs shall be designed to—
(A) make public health education more accessible to the public and private health
workforce;
(B) increase the relevance of public health
academic preparation to public health practice in the future;
(C) provide education or training for students from traditional on-campus programs
in practice-based sites; or
(D) develop educational methods and distance-based approaches or technology that
address adult learning requirements and increase knowledge and skills related to community-based cultural diversity in public
health education.
(2) Severe shortage disciplines
Amounts provided under grants or contracts
under this section may be used for the operation of programs designed to award traineeships to students in accredited schools of public health who enter educational programs in
fields where there is a severe shortage of public health professionals, including epidemiology, biostatistics, environmental health, toxicology, public health nursing, nutrition, preventive medicine, maternal and child health,
and behavioral and mental health professions.
(July 1, 1944, ch. 373, title VII, § 765, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3553; amended Pub. L. 111–148, title V,
§ 5206(a), Mar. 23, 2010, 124 Stat. 611.)
PRIOR PROVISIONS
A prior section 295, act July 1, 1944, ch. 373, title VII,
§ 781, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2055; amended Pub. L. 105–12, § 12(b), Apr. 30,
1997, 111 Stat. 29, authorized grants and contracts for
research on certain health professions issues, prior to
repeal by Pub. L. 105–392, title I, § 106(a)(1), Nov. 13, 1998,
112 Stat. 3557.
Another prior section 295, act July 1, 1944, ch. 373,
title VII, § 761, as added Dec. 25, 1970, Pub. L. 91–696,
§ 101, 84 Stat. 2080–1; amended Oct. 17, 1979, Pub. L. 96–88,
title III, § 301(a)(1), title V, § 507, 93 Stat. 677, 692, provided Congressional declaration of purpose for former
part D of this subchapter, prior to repeal by Pub. L.
99–129, title II, § 220(c), Oct. 22, 1985, 99 Stat. 544.
Another prior section 295, act July 1, 1944, ch. 373,
title VII, § 761, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 282, related to authorization of ap-

Page 818

propriations respecting grants for construction of mental retardation facilities, prior to the general amendment of former part D of this subchapter by section 101
of Pub. L. 91–696.
A prior section 765 of act July 1, 1944, was classified
to section 294c of this title prior to the general amendment of part D of this subchapter by Pub. L. 105–392.
Another prior section 765 of act July 1, 1944, was classified to section 295d of this title prior to repeal by
Pub. L. 99–129.
Another prior section 765 of act July 1, 1944, was classified to section 295d of this title prior to the general
amendment of part D of this subchapter by Pub. L.
91–696.
AMENDMENTS
2010—Subsec. (d)(8), (9). Pub. L. 111–148 added par. (8)
and redesignated former par. (8) as (9).

§ 295a. Public health training centers
(a) In general
The Secretary may make grants or contracts
for the operation of public health training centers.
(b) Eligible entities
(1) In general
A public health training center shall be an
accredited school of public health, or another
public or nonprofit private institution accredited for the provision of graduate or specialized training in public health, that plans, develops, operates, and evaluates projects that
are in furtherance of the goals established by
the Secretary for the year 2000 in the areas of
preventive medicine, health promotion and
disease prevention, or improving access to and
quality of health services in medically underserved communities.
(2) Preference
In awarding grants or contracts under this
section the Secretary shall give preference to
accredited schools of public health.
(c) Certain requirements
With respect to a public health training center, an award may not be made under subsection
(a) of this section unless the program agrees
that it—
(1) will establish or strengthen field placements for students in public or nonprofit private health agencies or organizations;
(2) will involve faculty members and students in collaborative projects to enhance public health services to medically underserved
communities;
(3) will specifically designate a geographic
area or medically underserved population to
be served by the center that shall be in a location removed from the main location of the
teaching facility of the school that is participating in the program with such center; and
(4) will assess the health personnel needs of
the area to be served by the center and assist
in the planning and development of training
programs to meet such needs.
(July 1, 1944, ch. 373, title VII, § 766, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3554.)
PRIOR PROVISIONS
A prior section 295a, act July 1, 1944, ch. 373, title VII,
§ 782, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,

Page 819

TITLE 42—THE PUBLIC HEALTH AND WELFARE

106 Stat. 2057, authorized grants and contracts for
chiropractic demonstration projects, prior to repeal by
Pub. L. 105–392, title I, § 106(a)(1), Nov. 13, 1998, 112 Stat.
3557.
Another prior section 295a, act July 1, 1944, ch. 373,
title VII, § 762, as added Dec. 25, 1970, Pub. L. 91–696,
§ 101, 84 Stat. 2080–2, authorized appropriations for
former part D of this subchapter, prior to repeal by
Pub. L. 99–129, title II, § 220(c), Oct. 22, 1985, 99 Stat. 544.
Another prior section 295a, act July 1, 1944, ch. 373,
title VII, § 762, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 282, related to applications for
grants for construction of mental retardation facilities,
including their approval by Surgeon General and consideration of certain matters, prior to the general
amendment of former part D of this subchapter by section 101 of Pub. L. 91–696.
A prior section 766 of act July 1, 1944, was classified
to section 294d of this title prior to the general amendment of part D of this subchapter by Pub. L. 105–392.
Another prior section 766 of act July 1, 1944, was classified to section 295d–1 of this title prior to repeal by
Pub. L. 99–129.
Another prior section 766 of act July 1, 1944, was classified to section 295d–1 of this title prior to the general
amendment of part D of this subchapter by Pub. L.
91–696.

§ 295b. Public health traineeships
(a) In general
The Secretary may make grants to accredited
schools of public health, and to other public or
nonprofit private institutions accredited for the
provision of graduate or specialized training in
public health, for the purpose of assisting such
schools and institutions in providing traineeships to individuals described in subsection
(b)(3) of this section.
(b) Certain requirements
(1) Amount
The amount of any grant under this section
shall be determined by the Secretary.
(2) Use of grant
Traineeships awarded under grants made
under subsection (a) of this section shall provide for tuition and fees and such stipends and
allowances (including travel and subsistence
expenses and dependency allowances) for the
trainees as the Secretary may deem necessary.
(3) Eligible individuals
The individuals referred to in subsection (a)
of this section are individuals who are pursuing a course of study in a health professions
field in which there is a severe shortage of
health professionals (which fields include the
fields of epidemiology, environmental health,
biostatistics, toxicology, nutrition, and maternal and child health).
(July 1, 1944, ch. 373, title VII, § 767, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3555.)
PRIOR PROVISIONS
A prior section 295b, act July 1, 1944, ch. 373, title VII,
§ 763, as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.
2080–2, authorized Secretary to make grants and to set
limitations and conditions on grants, required applications for grants, limited use of grant funds, set forth
method of payment of grants, and provided for protection of financial interests of the United States, prior to
repeal by Pub. L. 99–129, title II, § 220(c), Oct. 22, 1985, 99
Stat. 544.

§ 295c

Another prior section 295b, act July 1, 1944, ch. 373,
title VII, § 763, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 283, related to amount of grants for
construction of mental retardation facilities, including
maximum payments, advances or reimbursement, installments, conditions, and nonduplication of grants,
prior to the general amendment of former part D of
this subchapter by section 101 of Pub. L. 91–696.
A prior section 767 of act July 1, 1944, was classified
to section 295e–1 of this title prior to repeal by Pub. L.
99–129.
Another prior section 767 of act July 1, 1944, was classified to section 295d–2 of this title prior to repeal by
Pub. L. 99–129.

§ 295c. Preventive medicine and public health
training grant program
(a) Grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration and in consultation with the Director of the Centers for Disease Control and Prevention, shall award grants to, or enter into
contracts with, eligible entities to provide training to graduate medical residents in preventive
medicine specialties.
(b) Eligibility
To be eligible for a grant or contract under
subsection (a), an entity shall be—
(1) an accredited school of public health or
school of medicine or osteopathic medicine;
(2) an accredited public or private nonprofit
hospital;
(3) a State, local, or tribal health department; or
(4) a consortium of 2 or more entities described in paragraphs (1) through (3).
(c) Use of funds
Amounts received under a grant or contract
under this section shall be used to—
(1) plan, develop (including the development
of curricula), operate, or participate in an accredited residency or internship program in
preventive medicine or public health;
(2) defray the costs of practicum experiences, as required in such a program; and
(3) establish, maintain, or improve—
(A) academic administrative units (including departments, divisions, or other appropriate units) in preventive medicine and
public health; or
(B) programs that improve clinical teaching in preventive medicine and public
health.
(d) Report
The Secretary shall submit to the Congress an
annual report on the program carried out under
this section.
(July 1, 1944, ch. 373, title VII, § 768, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3555; amended Pub. L. 111–148, title X,
§ 10501(m)(1), Mar. 23, 2010, 124 Stat. 1001.)
PRIOR PROVISIONS
A prior section 295c, act July 1, 1944, ch. 373, title VII,
§ 764, as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.
2080–2; amended Oct. 17, 1979, Pub. L. 96–88, title III,
§ 301(a)(1), title V, § 507, 93 Stat. 677, 692, established requirements of eligibility for grants, prior to repeal by
Pub. L. 99–129, title II, § 220(c), Oct. 22, 1985, 99 Stat. 544.

§ 295d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Another prior section 295c, act July 1, 1944, ch. 373,
title VII, § 764, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 283, related to recovery of expenditures under certain conditions respecting grants for
construction of mental retardation facilities, prior to
the general amendment of former part D of this subchapter by section 101 of Pub. L. 91–696.
AMENDMENTS
2010—Pub. L. 111–148 amended section generally. Prior
to amendment, section related to grants and contracts
for residency training programs in preventive medicine
and dental public health and provision of financial assistance to residency trainees.

§ 295d. Health administration traineeships and
special projects
(a) In general
The Secretary may make grants to State or
local governments (that have in effect preventive medical and dental public health residency
programs) or public or nonprofit private educational entities (including graduate schools of
social work and business schools that have
health management programs) that offer a program described in subsection (b) of this section—
(1) to provide traineeships for students enrolled in such a program; and
(2) to assist accredited programs health administration in the development or improvement of programs to prepare students for employment with public or nonprofit private entities.
(b) Relevant programs
The program referred to in subsection (a) of
this section is an accredited program in health
administration, hospital administration, or
health policy analysis and planning, which program is accredited by a body or bodies approved
for such purpose by the Secretary of Education
and which meets such other quality standards as
the Secretary of Health and Human Services by
regulation may prescribe.
(c) Preference in making grants
In making grants under subsection (a) of this
section, the Secretary shall give preference to
qualified applicants that meet the following
conditions:
(1) Not less than 25 percent of the graduates
of the applicant are engaged in full-time practice settings in medically underserved communities.
(2) The applicant recruits and admits students from medically underserved communities.
(3) For the purpose of training students, the
applicant has established relationships with
public and nonprofit providers of health care
in the community involved.
(4) In training students, the applicant emphasizes employment with public or nonprofit
private entities.
(d) Certain provisions regarding traineeships
(1) Use of grant
Traineeships awarded under grants made
under subsection (a) of this section shall provide for tuition and fees and such stipends and
allowances (including travel and subsistence

Page 820

expenses and dependency allowances) for the
trainees as the Secretary may deem necessary.
(2) Preference for certain students
Each entity applying for a grant under subsection (a) of this section for traineeships
shall assure to the satisfaction of the Secretary that the entity will give priority to
awarding the traineeships to students who
demonstrate a commitment to employment
with public or nonprofit private entities in the
fields with respect to which the traineeships
are awarded.
(July 1, 1944, ch. 373, title VII, § 769, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3556.)
PRIOR PROVISIONS
A prior section 295d, act July 1, 1944, ch. 373, title VII,
§ 765, as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.
2080–3; amended Oct. 17, 1979, Pub. L. 96–88, title III,
§ 301(a)(1), title V, § 507, 93 Stat. 677, 692, related to requisites for approval of grants, establishment of separate medical school departments of family medicine,
establishment of special hospital programs of family
medicine, and supplementation of non-Federal funds,
prior to repeal by Pub. L. 99–129, title II, § 220(c), Oct.
22, 1985, 99 Stat. 544.
Another prior section 295d, act July 1, 1944, ch. 373,
title VII, § 765, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 284, related to noninterference
with administration of institutions respecting grants
for construction of mental retardation facilities, prior
to the general amendment of former part D of this subchapter by section 101 of Pub. L. 91–696.
Prior sections 295d–1 and 295d–2 were repealed by Pub.
L. 99–129, title II, § 220(c), Oct. 22, 1985, 99 Stat. 544.
Section 295d–1, act July 1, 1944, ch. 373, title VII, § 766,
as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.
2080–4, related to establishment and funding of planning
and developmental grants.
Another prior section 295d–1, act July 1, 1944, ch. 373,
title VII, § 766, as added Oct. 31, 1963, Pub. L. 88–164,
title I, § 101, 77 Stat. 284, related to definitions in connection with grants for construction of mental retardation research facilities, prior to the general amendment of former part D of this subchapter by section 101
of Pub. L. 91–696.
Section 295d–2, act July 1, 1944, ch. 373, title VII, § 767,
as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.
2080–4, established Advisory Council on Family Medicine and provided for its composition, term and compensation of its members, and its duties and functions.

§ 295e. Authorization of appropriations
(a) In general
For the purpose of carrying out this subpart,
there is authorized to be appropriated $43,000,000
for fiscal year 2011, and such sums as may be
necessary for each of the fiscal years 2012
through 2015.
(b) Limitation regarding certain program
In obligating amounts appropriated under subsection (a) of this section, the Secretary may
not obligate more than 30 percent for carrying
out section 295b of this title.
(July 1, 1944, ch. 373, title VII, § 770, as added
Pub. L. 105–392, title I, § 105, Nov. 13, 1998, 112
Stat. 3556; amended Pub. L. 111–148, title X,
§ 10501(m)(2), Mar. 23, 2010, 124 Stat. 1002.)
PRIOR PROVISIONS
A prior section 295e, act July 1, 1944, ch. 373, title VII,
§ 768, as added Dec. 25, 1970, Pub. L. 91–696, § 101, 84 Stat.

Page 821

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2080–5, set forth definitions for former part D of this
subchapter, prior to repeal by Pub. L. 99–129, title II,
§ 220(c), Oct. 22, 1985, 99 Stat. 544.
Another prior section 295e consisted of section 766 of
act July 1, 1944. The classification of section 766 of act
July 1, 1944, was changed to section 295d–1 of this title
for purposes of codification.
Prior sections 295e–1 to 295e–5 were repealed by Pub.
L. 99–129, title II, § 220(c), Oct. 22, 1985, 99 Stat. 544.
Section 295e–1, act July 1, 1944, ch. 373, title VII, § 767,
as added Nov. 18, 1971, Pub. L. 92–157, title I, § 107(b), 85
Stat. 457; amended Oct. 12, 1976, Pub. L. 94–484, title I,
§ 101(g), 90 Stat. 2244, authorized appropriations for
grants to public or nonprofit private hospitals for
training, traineeships, and fellowships in family medicine.
Section 295e–2, act July 1, 1944, ch. 373, title VII, § 768,
as added Nov. 18, 1971, Pub. L. 92–157, title I, § 107(b), 85
Stat. 458; amended Oct. 12, 1976, Pub. L. 94–484, title I,
§ 101(h), 90 Stat. 2244, established grants for postgraduate training programs for physicians and dentists
and authorized appropriations for those grants.
Section 295e–3, act July 1, 1944, ch. 373, title VII, § 769,
as added Nov. 18, 1971, Pub. L. 92–157, title I, § 107(b), 85
Stat. 459; amended Oct. 12, 1976, Pub. L. 94–484, title I,
§ 101(i), 90 Stat. 2245, authorized the Secretary to make
grants for training, traineeships, and fellowships for
health professions teaching personnel and authorized
appropriations for those grants.
Section 295e–4, act July 1, 1944, ch. 373, title VII,
§ 769A, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 107(b), 85 Stat. 459; amended Oct. 12, 1976, Pub. L.
94–484, title I, § 101(j), 90 Stat. 2245, authorized appropriations for grants for computer technology health
care demonstration programs.
Section 295e–5, act July 1, 1944, ch. 373, title VII,
§ 769B, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 107(b), 85 Stat. 460, required applications for grants
and approval of grants by Secretary and set forth payment limitations.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148 amended subsec. (a)
generally. Prior to amendment, text read as follows:
‘‘For the purpose of carrying out this subpart, there is
authorized to be appropriated $9,100,000 for fiscal year
1998, and such sums as may be necessary for each of the
fiscal years 1999 through 2002.’’
SUBPART 3—RECRUITMENT AND RETENTION
PROGRAMS

§ 295f. Investment in tomorrow’s pediatric health
care workforce
(a) Establishment
The Secretary shall establish and carry out a
pediatric specialty loan repayment program
under which the eligible individual agrees to be
employed full-time for a specified period (which
shall not be less than 2 years) in providing pediatric medical subspecialty, pediatric surgical
specialty, or child and adolescent mental and
behavioral health care, including substance
abuse prevention and treatment services.
(b) Program administration
Through the program established under this
section, the Secretary shall enter into contracts
with qualified health professionals under
which—
(1) such qualified health professionals will
agree to provide pediatric medical subspecialty, pediatric surgical specialty, or child
and adolescent mental and behavioral health
care in an area with a shortage of the specified
pediatric subspecialty that has a sufficient pe-

§ 295f

diatric population to support such pediatric
subspecialty, as determined by the Secretary;
and
(2) the Secretary agrees to make payments
on the principal and interest of undergraduate, graduate, or graduate medical education
loans of professionals described in paragraph
(1) of not more than $35,000 a year for each
year of agreed upon service under such paragraph for a period of not more than 3 years
during the qualified health professional’s—
(A) participation in an accredited pediatric
medical subspecialty, pediatric surgical specialty, or child and adolescent mental health
subspecialty residency or fellowship; or
(B) employment as a pediatric medical
subspecialist, pediatric surgical specialist,
or child and adolescent mental health professional serving an area or population described in such paragraph.
(c) In general
(1) Eligible individuals
(A) Pediatric medical specialists and pediatric surgical specialists
For purposes of contracts with respect to
pediatric medical specialists and pediatric
surgical specialists, the term ‘‘qualified
health professional’’ means a licensed physician who—
(i) is entering or receiving training in an
accredited pediatric medical subspecialty
or pediatric surgical specialty residency or
fellowship; or
(ii) has completed (but not prior to the
end of the calendar year in which this section is enacted) the training described in
subparagraph (B).
(B) Child and adolescent mental and behavioral health
For purposes of contracts with respect to
child and adolescent mental and behavioral
health care, the term ‘‘qualified health professional’’ means a health care professional
who—
(i) has received specialized training or
clinical experience in child and adolescent
mental health in psychiatry, psychology,
school psychology, behavioral pediatrics,
psychiatric nursing, social work, school
social work, substance abuse disorder prevention and treatment, marriage and family therapy, school counseling, or professional counseling;
(ii) has a license or certification in a
State to practice allopathic medicine, osteopathic medicine, psychology, school
psychology, psychiatric nursing, social
work, school social work, marriage and
family therapy, school counseling, or professional counseling; or
(iii) is a mental health service professional who completed (but not before the
end of the calendar year in which this section is enacted) specialized training or
clinical experience in child and adolescent
mental health described in clause (i).
(2) Additional eligibility requirements
The Secretary may not enter into a contract
under this subsection with an eligible individual unless—

§ 295f–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the individual agrees to work in, or for
a provider serving, a health professional
shortage area or medically underserved area,
or to serve a medically underserved population;
(B) the individual is a United States citizen or a permanent legal United States resident; and
(C) if the individual is enrolled in a graduate program, the program is accredited,
and the individual has an acceptable level of
academic standing (as determined by the
Secretary).
(d) Priority
In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
(1) are or will be working in a school or
other pre-kindergarten, elementary, or secondary education setting;
(2) have familiarity with evidence-based
methods and cultural and linguistic competence health care services; and
(3) demonstrate financial need.
(e) Authorization of appropriations
There is authorized to be appropriated
$30,000,000 for each of fiscal years 2010 through
2014 to carry out subsection (c)(1)(A) and
$20,000,000 for each of fiscal years 2010 through
2013 to carry out subsection (c)(1)(B).
(July 1, 1944, ch. 373, title VII, § 775, as added
Pub. L. 111–148, title V, § 5203, Mar. 23, 2010, 124
Stat. 607.)
REFERENCES IN TEXT
The calendar year in which this section is enacted,
referred to in subsec. (c)(1)(A)(ii), (B)(iii), probably
means the calendar year in which Pub. L. 111–148 was
enacted. Such Act was approved Mar. 23, 2010.
PRIOR PROVISIONS
A prior section 295f, act July 1, 1944, ch. 373, title VII,
§ 770, as added Oct. 22, 1965, Pub. L. 89–290, § 2(a), 79 Stat.
1052; amended Aug. 16, 1968, Pub. L. 90–490, title I,
§ 111(a), 82 Stat. 774; Nov. 18, 1971, Pub. L. 92–157, title I,
§ 104(a), 85 Stat. 437; Oct. 12, 1976, Pub. L. 94–484, title I,
§ 101(k), title V, § 501(a)–(c), 90 Stat. 2245, 2290, 2291; Aug.
13, 1981, Pub. L. 97–35, title XXVII, § 2746(a)(1), 95 Stat.
927; Oct. 22, 1985, Pub. L. 99–129, title II, § 211(a)(1), 99
Stat. 537; Nov. 4, 1988, Pub. L. 100–607, title VI, § 606(a),
102 Stat. 3127, related to capitation grants for schools
of public health, prior to repeal by act July 1, 1944, ch.
373, title VII, § 773, as added Nov. 4, 1988, Pub. L. 100–607,
title VI, § 606(b), 102 Stat. 3127, effective Oct. 1, 1990.
A prior section 775 of act July 1, 1944, was renumbered
section 772 by Pub. L. 94–484, and was classified to section 295f–2 of this title prior to repeal by act July 1,
1944, ch. 373, title VII, § 773, as added Nov. 4, 1988, Pub.
L. 100–607, title VI, § 606(b), 102 Stat. 3127.

§ 295f–1. Public Health Workforce Loan Repayment Program
(a) Establishment
The Secretary shall establish the Public
Health Workforce Loan Repayment Program
(referred to in this section as the ‘‘Program’’) to
assure an adequate supply of public health professionals to eliminate critical public health
workforce shortages in Federal, State, local, and
tribal public health agencies.
(b) Eligibility
To be eligible to participate in the Program,
an individual shall—

Page 822

(1)(A) be accepted for enrollment, or be enrolled, as a student in an accredited academic
educational institution in a State or territory
in the final year of a course of study or program leading to a public health or health professions degree or certificate; and have accepted employment with a Federal, State, local, or
tribal public health agency, or a related training fellowship, as recognized by the Secretary,
to commence upon graduation;
(B)(i) have graduated, during the preceding
10-year period, from an accredited educational
institution in a State or territory and received
a public health or health professions degree or
certificate; and
(ii) be employed by, or have accepted employment with, a Federal, State, local, or tribal public health agency or a related training
fellowship, as recognized by the Secretary;
(2) be a United States citizen; and
(3)(A) submit an application to the Secretary to participate in the Program;
(B) execute a written contract as required in
subsection (c); and
(4) not have received, for the same service, a
reduction of loan obligations under section
1087e(m), 1078–10, 1078–11, 1078–12, or 1087j of
title 20.
(c) Contract
The written contract (referred to in this section as the ‘‘written contract’’) between the Secretary and an individual shall contain—
(1) an agreement on the part of the Secretary that the Secretary will repay on behalf
of the individual loans incurred by the individual in the pursuit of the relevant degree or
certificate in accordance with the terms of the
contract;
(2) an agreement on the part of the individual that the individual will serve in the fulltime employment of a Federal, State, local, or
tribal public health agency or a related fellowship program in a position related to the
course of study or program for which the contract was awarded for a period of time (referred to in this section as the ‘‘period of obligated service’’) equal to the greater of—
(A) 3 years; or
(B) such longer period of time as determined appropriate by the Secretary and the
individual;
(3) an agreement, as appropriate, on the part
of the individual to relocate to a priority service area (as determined by the Secretary) in
exchange for an additional loan repayment incentive amount to be determined by the Secretary;
(4) a provision that any financial obligation
of the United States arising out of a contract
entered into under this section and any obligation of the individual that is conditioned
thereon, is contingent on funds being appropriated for loan repayments under this section;
(5) a statement of the damages to which the
United States is entitled,1 under this section
for the individual’s breach of the contract; and
(6) such other statements of the rights and
liabilities of the Secretary and of the individual, not inconsistent with this section.
1 So

in original. The comma probably should not appear.

Page 823

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Payments
(1) In general
A loan repayment provided for an individual
under a written contract under the Program
shall consist of payment, in accordance with
paragraph (2), on behalf of the individual of
the principal, interest, and related expenses on
government and commercial loans received by
the individual regarding the undergraduate or
graduate education of the individual (or both),
which loans were made for tuition expenses incurred by the individual.
(2) Payments for years served
For each year of obligated service that an
individual contracts to serve under subsection
(c) the Secretary may pay up to $35,000 on behalf of the individual for loans described in
paragraph (1). With respect to participants
under the Program whose total eligible loans
are less than $105,000, the Secretary shall pay
an amount that does not exceed 1⁄3 of the eligible loan balance for each year of obligated
service of the individual.
(3) Tax liability
For the purpose of providing reimbursements for tax liability resulting from payments under paragraph (2) on behalf of an individual, the Secretary shall, in addition to such
payments, make payments to the individual in
an amount not to exceed 39 percent of the
total amount of loan repayments made for the
taxable year involved.
(e) Postponing obligated service
With respect to an individual receiving a degree or certificate from a health professions or
other related school, the date of the initiation of
the period of obligated service may be postponed
as approved by the Secretary.
(f) Breach of contract
An individual who fails to comply with the
contract entered into under subsection (c) shall
be subject to the same financial penalties as
provided for under section 254o of this title for
breaches of loan repayment contracts under section 254l–1 of this title.
(g) Authorization of appropriations
There is authorized to be appropriated to
carry out this section $195,000,000 for fiscal year
2010, and such sums as may be necessary for
each of fiscal years 2011 through 2015.
(July 1, 1944, ch. 373, title VII, § 776, as added
Pub. L. 111–148, title V, § 5204, Mar. 23, 2010, 124
Stat. 609.)
PRIOR PROVISIONS
A prior section 295f–1, act July 1, 1944, ch. 373, title
VII, § 771, as added Oct. 12, 1976, Pub. L. 94–484, title V,
§ 502, 90 Stat. 2293; amended Aug. 1, 1977, Pub. L. 95–83,
title III, § 307(i), 91 Stat. 391; Dec. 19, 1977, Pub. L.
95–215, §§ 1(a), 2, 91 Stat. 1503, 1504; Nov. 9, 1978, Pub. L.
95–623, §§ 11(g), 12(d), 92 Stat. 3456, 3457; Sept. 29, 1979,
Pub. L. 96–76, title II, § 207, 93 Stat. 583; Aug. 13, 1981,
Pub. L. 97–35, title XXVII, § 2746(a)(2), 95 Stat. 927; Oct.
22, 1985, Pub. L. 99–129, title II, § 211(b), 99 Stat. 539, related to eligibility for capitation grants, prior to repeal
by act July 1, 1944, ch. 373, title VII, § 773, as added Nov.
4, 1988, Pub. L. 100–607, title VI, § 606(b), 102 Stat. 3127,
effective Oct. 1, 1990.

§ 295f–2

Another prior section 295f–1, act July 1, 1944, ch. 373,
title VII, § 771, as added Oct. 22, 1965, Pub. L. 89–290,
§ 2(a), 79 Stat. 1052; amended Aug. 16, 1968, Pub. L.
90–490, title I, § 111(a), 82 Stat. 775; Nov. 2, 1970, Pub. L.
91–519, title I, § 101(a), 84 Stat. 1343; Nov. 18, 1971, Pub.
L. 92–157, title I, § 104(a), 85 Stat. 443; Oct. 12, 1976, Pub.
L. 94–484, title I, § 101(l), 90 Stat. 2245, authorized startup assistance, prior to repeal by Pub. L. 94–484, title V,
§ 502, Oct. 12, 1976, 90 Stat. 2293, effective with respect to
fiscal years beginning after Sept. 30, 1977.
A prior section 776 of act July 1, 1944, was renumbered
section 2692 and is classified to section 300ff–111 of this
title.
Another prior section 776 of act July 1, 1944, was renumbered section 789, and was classified to section
295g–9 of this title prior to repeal by Pub. L. 99–129,
title II, § 220(g), Oct. 22, 1985, 99 Stat. 544.

§ 295f–2. Training for mid-career public and allied health professionals
(a) In general
The Secretary may make grants to, or enter
into contracts with, any eligible entity to award
scholarships to eligible individuals to enroll in
degree or professional training programs for the
purpose of enabling mid-career professionals in
the public health and allied health workforce to
receive additional training in the field of public
health and allied health.
(b) Eligibility
(1) Eligible entity
The term ‘‘eligible entity’’ indicates an accredited educational institution that offers a
course of study, certificate program, or professional training program in public or allied
health or a related discipline, as determined
by the Secretary 1
(2) Eligible individuals
The term ‘‘eligible individuals’’ includes
those individuals employed in public and allied health positions at the Federal, State,
tribal, or local level who are interested in retaining or upgrading their education.
(c) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $60,000,000 for fiscal year
2010 and such sums as may be necessary for each
of fiscal years 2011 through 2015. Fifty percent of
appropriated funds shall be allotted to public
health mid-career professionals and 50 percent
shall be allotted to allied health mid-career professionals.
(July 1, 1944, ch. 373, title VII, § 777, as added
Pub. L. 111–148, title V, § 5206(b), Mar. 23, 2010, 124
Stat. 612.)
PRIOR PROVISIONS
A prior section 295f–2, act July 1, 1944, ch. 373, title
VII, § 772, formerly § 775, as added Nov. 18, 1971, Pub. L.
92–157, title I, § 104(a), 85 Stat. 448; renumbered § 772 and
amended Oct. 12, 1976, Pub. L. 94–484, title V, § 503(a), 90
Stat. 2300; Dec. 19, 1977, Pub. L. 95–215, §§ 1(b), 8(c), 91
Stat. 1504, 1507; Nov. 9, 1978, Pub. L. 95–623, § 12(j), 92
Stat. 3457; Oct. 22, 1985, Pub. L. 99–129, title II, § 211(c),
99 Stat. 539, related to applications for capitation
grants, prior to repeal by act July 1, 1944, ch. 373, title
VII, § 773, as added Nov. 4, 1988, Pub. L. 100–607, title VI,
§ 606(b), 102 Stat. 3127, effective Oct. 1, 1990.
Another prior section 295f–2, act July 1, 1944, ch. 373,
title VII, § 772, as added Oct. 22, 1965, Pub. L. 89–290,
1 So

in original. Probably should be followed by a period.

§ 295f–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 2(a), 79 Stat. 1053; amended Aug. 16, 1968, Pub. L.
90–490, title I, § 111(a), (e), 82 Stat. 776, 777; Nov. 2, 1970,
Pub. L. 91–519, title I, § 102(a), 84 Stat. 1343; Nov. 18, 1971,
Pub. L. 92–157, title I, § 104(a), 85 Stat. 444; Nov. 16, 1973,
Pub. L. 93–154, § 3(b), 87 Stat. 604; July 12, 1974, Pub. L.
93–348, title II, § 215, 88 Stat. 354; Oct. 12, 1976, Pub. L.
94–484, title I, § 101(m), 90 Stat. 2245, provided special
project grants and contracts, prior to repeal by Pub. L.
94–484, title V, § 502, Oct. 12, 1976, 90 Stat. 2293, effective
with respect to fiscal years beginning after Sept. 30,
1977.
A prior section 777 of act July 1, 1944, was classified
to section 294o of this title prior to the general amendment of this part by Pub. L. 105–392.

§ 295f–3. Fellowship training in applied public
health epidemiology, public health laboratory science, public health informatics, and
expansion of the Epidemic Intelligence Service
(a) In general
The Secretary may carry out activities to address documented workforce shortages in State
and local health departments in the critical
areas of applied public health epidemiology and
public health laboratory science and informatics
and may expand the Epidemic Intelligence Service.
(b) Specific uses
In carrying out subsection (a), the Secretary
shall provide for the expansion of existing fellowship programs operated through the Centers
for Disease Control and Prevention in a manner
that is designed to alleviate shortages of the
type described in subsection (a).
(c) Other programs
The Secretary may provide for the expansion
of other applied epidemiology training programs
that meet objectives similar to the objectives of
the programs described in subsection (b).
(d) Work obligation
Participation in fellowship training programs
under this section shall be deemed to be service
for purposes of satisfying work obligations stipulated in contracts under section 254q–1(j) of
this title.
(e) General support
Amounts may be used from grants awarded
under this section to expand the Public Health
Informatics Fellowship Program at the Centers
for Disease Control and Prevention to better
support all public health systems at all levels of
government.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $39,500,000 for each of fiscal years 2010 through 2013, of which—
(1) $5,000,000 shall be made available in each
such fiscal year for epidemiology fellowship
training program activities under subsections
(b) and (c);
(2) $5,000,000 shall be made available in each
such fiscal year for laboratory fellowship
training programs under subsection (b);
(3) $5,000,000 shall be made available in each
such fiscal year for the Public Health Informatics Fellowship Program under subsection
(e); and
(4) $24,500,000 shall be made available for expanding the Epidemic Intelligence Service
under subsection (a).

Page 824

(July 1, 1944, ch. 373, title VII, § 778, as added
Pub. L. 111–148, title V, § 5314, Mar. 23, 2010, 124
Stat. 636.)
PRIOR PROVISIONS
A prior section 295f–3, act July 1, 1944, ch. 373, title
VII, § 773, as added Nov. 4, 1988, Pub. L. 100–607, title VI,
§ 606(b), 102 Stat. 3127, provided for repeal of former part
D of this subchapter, effective Oct. 1, 1990, prior to repeal by act July 1, 1944, ch. 373, title VII, § 773, as added
Nov. 4, 1988, Pub. L. 100–607, title VI, § 606(b), 102 Stat.
3127, effective Oct. 1, 1990.
Another prior section 295f–3, act July 1, 1944, ch. 373,
title VII, § 773, as added Oct. 22, 1965, Pub. L. 89–290,
§ 2(a), 79 Stat. 1053; amended Aug. 16, 1968, Pub. L.
90–490, title I, § 111(b), 82 Stat. 776; Nov. 18, 1971, Pub. L.
92–157, title I, § 104(a), 85 Stat. 446; July 12, 1974, Pub. L.
93–348, title I, § 106, 88 Stat. 347; Oct. 12, 1976, Pub. L.
94–484, title I, § 101(n), 90 Stat. 2245, authorized grants to
assist health professions schools which were in financial distress, prior to repeal by Pub. L. 94–484, title V,
§ 502, Oct. 12, 1976, 90 Stat. 2293, effective with respect to
fiscal years beginning after Sept. 30, 1977.
A prior section 778 of act July 1, 1944, was classified
to section 294p of this title prior to the general amendment of this part by Pub. L. 105–392.
A prior section 295f–4, act July 1, 1944, ch. 373, title
VII, § 774, as added Oct. 22, 1965, Pub. L. 89–290, § 2(a), 79
Stat. 1054; amended Aug. 16, 1968, Pub. L. 90–490, title I,
§ 111(c)(1), (2), 82 Stat. 777; Oct. 30, 1970, Pub. L. 91–515,
title VI, § 601(b)(2), 84 Stat. 1311; Nov. 18, 1971, Pub. L.
92–157, title I, § 104(a), 85 Stat. 446; Nov. 16, 1973, Pub. L.
93–154, § 3(c), 87 Stat. 605; Oct. 12, 1976, Pub. L. 94–484,
title I, § 101(o), 90 Stat. 2245, authorized health manpower education initiative awards prior to repeal by
Pub. L. 94–484, title V, § 502, Oct. 12, 1976, 90 Stat. 2293,
effective with respect to fiscal years beginning after
Sept. 30, 1977.
A prior section 295f–5, act July 1, 1944, ch. 373, title
VII, § 775, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 104(a), 85 Stat. 448, which related to applications for
capitation, start-up, special project, and financial distress grants, was renumbered section 772 of act July 1,
1944, by Pub. L. 94–484 and transferred to section 295f–2
of this title.
A prior section 295f–6, act July 1, 1944, ch. 373, title
VII, § 776, as added Nov. 16, 1973, Pub. L. 93–154, § 3(a), 87
Stat. 604, which related to training in emergency medical services, was renumbered section 789 of act July 1,
1944, by Pub. L. 94–484 and transferred to section 295g–9
of this title.
Prior sections 295g to 295g–2 were omitted in the general amendment of this subchapter by Pub. L. 102–408.
Section 295g, act July 1, 1944, ch. 373, title VII, § 780,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2311; amended Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2738, 95 Stat. 921; Oct. 22, 1985, Pub. L. 99–129,
title I, § 103, title II, § 212, 99 Stat. 523, 540; Nov. 4, 1988,
Pub. L. 100–607, title VI, §§ 607, 629(b)(1), 102 Stat. 3127,
3146; Aug. 16, 1989, Pub. L. 101–93, § 5(o)(3), 103 Stat. 614,
related to project grants for establishment of departments of family medicine.
Another prior section 295g, act July 1, 1944, ch. 373,
title VII, § 780, as added Oct. 22, 1965, Pub. L. 89–290,
§ 2(a), 79 Stat. 1055; amended Aug. 16, 1968, Pub. L.
90–490, title I, §§ 111(c)(4), 122(a) to (c), 82 Stat. 777, 779;
July 9, 1971, Pub. L. 92–52, § 2, 85 Stat. 144; Nov. 18, 1971,
Pub. L. 92–157, title I, §§ 106(a), (b)(3), (4), 108(b)(2), title
III, § 301(g), 85 Stat. 452, 453, 461, 464; Oct. 12, 1976, Pub.
L. 94–484, title I, § 101(p), 90 Stat. 2245, related to scholarship grants for study in United States, prior to repeal
by Pub. L. 94–484, title IV, § 409(a), Oct. 12, 1976, 90 Stat.
2290, effective Oct. 1, 1976.
Section 295g–1, act July 1, 1944, ch. 373, title VII, § 781,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2312; amended Aug. 1, 1977, Pub. L. 95–83, title
III, § 307(j), 91 Stat. 392; Sept. 29, 1979, Pub. L. 96–76, title
II, § 203, 93 Stat. 582; Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2739, 95 Stat. 921; Jan. 4, 1983, Pub. L. 97–414,

Page 825

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 8(j), 96 Stat. 2061; Aug. 15, 1985, Pub. L. 99–91, § 7, 99
Stat. 392; Oct. 22, 1985, Pub. L. 99–129, title I, § 104, title
II, § 213, 99 Stat. 523, 540; Nov. 4, 1988, Pub. L. 100–607,
title VI, §§ 608, 629(b)(3), 102 Stat. 3127, 3146; Aug. 16,
1989, Pub. L. 101–93, § 5(o)(3), (5), (6), 103 Stat. 614; Nov.
16, 1990, Pub. L. 101–597, title IV, § 401(b)[(a)], 104 Stat.
3035, related to area health education centers.
Another prior section 295g–1, act July 1, 1944, ch. 373,
title VII, § 781, as added Aug. 16, 1968, Pub. L. 90–490,
title I, § 122(d), 82 Stat. 779; amended Nov. 18, 1971, Pub.
L. 92–157, title I, §§ 105(f)(3), 106(b)(4), 85 Stat. 451, 453,
provided for transfer of monies to student loan fund,
prior to repeal by Pub. L. 94–484, title IV, § 409(a), Oct.
12, 1976, 90 Stat. 2290, effective Oct. 1, 1976.
Section 295g–2, act July 1, 1944, ch. 373, title VII, § 782,
formerly § 788A, as added Aug. 18, 1987, Pub. L. 100–97,
§ 3, 101 Stat. 713; renumbered § 782 and amended Nov. 4,
1988, Pub. L. 100–607, title VI, § 614, 102 Stat. 3136;
amended Aug. 16, 1989, Pub. L. 101–93, § 5(i), 103 Stat. 613;
Nov. 6, 1990, Pub. L. 101–527, § 4(a), 104 Stat. 2318, provided for programs of excellence in health professions
education for minorities. See section 293 of this title.
Another prior section 295g–2, act July 1, 1944, ch. 373,
title VII, § 782, as added Oct. 12, 1976, Pub. L. 94–484,
title VIII, § 801(a), 90 Stat. 2314; amended Nov. 9, 1978,
Pub. L. 95–623, § 12(e), 92 Stat. 3457, authorized Secretary to make grants to schools of medicine and osteopathy for programs to train United States citizens formerly enrolled in medical schools in foreign countries,
authorized appropriations for those grants, and set
forth reporting requirements, prior to repeal by Pub. L.
99–129, title II, § 220(d), Oct. 22, 1985, 99 Stat. 544.
A prior section 295g–3, act July 1, 1944, ch. 373, title
VII, § 783, as added Oct. 12, 1976, Pub. L. 94–484, title
VIII, § 801(a), 90 Stat. 2314; amended Aug. 13, 1981, Pub.
L. 97–35, title XXVII, § 2740, 95 Stat. 922; Oct. 22, 1985,
Pub. L. 99–129, title I, § 105, 99 Stat. 524, related to programs for physician assistants, prior to repeal by Pub.
L. 100–607, title VI, § 615(b), Nov. 4, 1988, 102 Stat. 3138.
Prior sections 295g–4 to 295g–8 were omitted in the
general amendment of this subchapter by Pub. L.
102–408.
Section 295g–4, act July 1, 1944, ch. 373, title VII, § 784,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2315; amended Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2741, 95 Stat. 922; Jan. 4, 1983, Pub. L. 97–414,
§ 9(f), 96 Stat. 2064; Oct. 22, 1985, Pub. L. 99–129, title I,
§ 106, title II, § 214, 99 Stat. 524, 540; Nov. 4, 1988, Pub. L.
100–607, title VI, § 609, 102 Stat. 3130; Nov. 18, 1988, Pub.
L. 100–690, title II, § 2615(c), 102 Stat. 4239; Aug. 16, 1989,
Pub. L. 101–93, § 5(o)(3), 103 Stat. 614, related to grants
and contracts for training, traineeships, and fellowships in general internal medicine and general pediatrics.
Section 295g–5, act July 1, 1944, ch. 373, title VII, § 785,
as added Nov. 4, 1988, Pub. L. 100–607, title VI, § 610(a)(2),
102 Stat. 3130, related to residency programs in the general practice of dentistry.
Another prior section 295g–5, act July 1, 1944, ch. 373,
title VII, § 785, as added Oct. 12, 1976, Pub. L. 94–484,
title VIII, § 801(a), 90 Stat. 2315, established grants to
public or private nonprofit colleges or universities for
occupational health training and education centers and
authorized appropriations for those grants, prior to repeal by Pub. L. 99–129, title II, § 220(e), Oct. 22, 1985, 99
Stat. 544.
Section 295g–6, act July 1, 1944, ch. 373, title VII, § 786,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2316; amended Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2742, 95 Stat. 923; Oct. 22, 1985, Pub. L. 99–129,
title I, § 107, title II, § 215, 99 Stat. 524, 540; Nov. 4, 1988,
Pub. L. 100–607, title VI, § 610(a)(1), (b), 102 Stat. 3130,
3131; Aug. 16, 1989, Pub. L. 101–93, § 5(o)(3), (6), 103 Stat.
614, related to grants and contracts for specified family
medicine programs.
Section 295g–7, act July 1, 1944, ch. 373, title VII, § 787,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2317; amended Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2743, 95 Stat. 923; Oct. 22, 1985, Pub. L. 99–129,
title I, § 108, title II, § 216, 99 Stat. 524, 541; Nov. 4, 1988,

§ 295f–3

Pub. L. 100–607, title VI, §§ 611(a)–(e), 628(10), 629(b)(2),
102 Stat. 3131, 3132, 3146; Nov. 18, 1988, Pub. L. 100–690,
title II, § 2615(d), (e), 102 Stat. 4239; Aug. 16, 1989, Pub. L.
101–93, § 5(h), (o)(2), 103 Stat. 612, 614, related to educational assistance to individuals from disadvantaged
backgrounds. See section 293c of this title.
Section 295g–7a, act July 1, 1944, ch. 373, title VII,
§ 787A, as added and amended Nov. 4, 1988, Pub. L.
100–607, title VI, §§ 612, 629(b)(2), 102 Stat. 3132, 3146, related to a retention program for health professions
schools with individuals from disadvantaged backgrounds. See section 293 et seq. of this title.
Section 295g–8, act July 1, 1944, ch. 373, title VII, § 788,
as added Oct. 12, 1976, Pub. L. 94–484, title VIII, § 801(a),
90 Stat. 2318; amended Nov. 9, 1978, Pub. L. 95–623, § 12(f),
92 Stat. 3457; Sept. 29, 1979, Pub. L. 96–76, title II, § 205,
93 Stat. 583; Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2744(a)(1), (b)–(f), 95 Stat. 923, 924; Oct. 22, 1985, Pub. L.
99–129, title I, § 109, title II, § 217, 99 Stat. 524, 541; Nov.
14, 1986, Pub. L. 99–660, title VI, § 601, 100 Stat. 3797; Dec.
1, 1987, Pub. L. 100–177, title IV, § 401, 101 Stat. 1007; Nov.
4, 1988, Pub. L. 100–607, title VI, §§ 613(a), 628(11),
629(b)(2), 102 Stat. 3133, 3146; Aug. 16, 1989, Pub. L.
101–93, § 5(o)(2), (3), 103 Stat. 614; July 23, 1992, Pub. L.
102–325, title XV, § 1559, 106 Stat. 841, related to grants
and contracts for special projects.
Another prior section 295g–8, act July 1, 1944, ch. 373,
title VII, § 788A, as added Aug. 18, 1987, Pub. L. 100–97,
§ 3, 101 Stat. 713, which related to grants for minority
education, was renumbered section 782 of act July 1,
1944, by Pub. L. 100–607 and transferred to section 295g–2
of this title.
A prior section 295g–8a, act July 1, 1944, ch. 373, title
VII, § 788A, as added Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2745, 95 Stat. 925, authorized Secretary to
make grants or enter into contracts with schools in serious financial distress to assist their operations, under
certain terms and conditions, prior to repeal by Pub. L.
99–129, title II, § 220(f)(1), Oct. 22, 1985, 99 Stat. 544.
Prior sections 295g–8b to 295g–10 were omitted in the
general amendment of this subchapter by Pub. L.
102–408.
Section 295g–8b, act July 1, 1944, ch. 373, title VII,
§ 788A, formerly § 788B, as added Aug. 13, 1981, Pub. L.
97–35, title XXVII, § 2745, 95 Stat. 926; amended Oct. 22,
1985, Pub. L. 99–129, title I, § 110, title II, §§ 218,
220(f)(2)–(4), 99 Stat. 524, 543, 544; Nov. 4, 1988, Pub. L.
100–607, title VI, §§ 622, 629(b)(2), 102 Stat. 3141, 3146; Nov.
18, 1988, Pub. L. 100–690, title II, § 2615(g), 102 Stat. 4239;
renumbered § 788A and amended Aug. 16, 1989, Pub. L.
101–93, § 5(k), (o)(4), 103 Stat. 613, 614, related to training
with respect to acquired immune deficiency syndrome.
See section 300ff–111 of this title.
Section 295g–9, act July 1, 1944, ch. 373, title VII, § 789,
as added and amended Nov. 4, 1988, Pub. L. 100–607, title
VI, §§ 615(a), 629(b)(1), 102 Stat. 3136, 3146; Aug. 16, 1989,
Pub. L. 101–93, § 5(o)(3), 103 Stat. 614, related to geriatric
education centers and geriatric training.
Another prior section 295g–9, act July 1, 1944, ch. 373,
title VII, § 789, formerly § 776, as added Nov. 16, 1973,
Pub. L. 93–154, § 3(a), 87 Stat. 604; renumbered § 789, Oct.
12, 1976, Pub. L. 94–484, title VIII, § 801(b), 90 Stat. 2322;
amended Oct. 21, 1976, Pub. L. 94–573, § 12, 90 Stat. 2717;
July 10, 1979, Pub. L. 96–32, § 7(h), 93 Stat. 84; Aug. 1,
1977, Pub. L. 95–83, title III, § 307(k), 91 Stat. 392; Dec. 12,
1979, Pub. L. 96–142, title I, § 102, 93 Stat. 1067, authorized Secretary to make grants and enter into contracts
for training in emergency medical services, set forth
eligibility requirements and amounts, directed Secretary to use a uniform funding cycle, and authorized
appropriations for those grants and contracts, prior to
repeal by Pub. L. 99–129, title II, § 220(g), Oct. 22, 1985,
99 Stat. 544.
Section 295g–10, act July 1, 1944, ch. 373, title VII,
§ 790, as added Oct. 12, 1976, Pub. L. 94–484, title VIII,
§ 801(c), 90 Stat. 2322; amended Nov. 4, 1988, Pub. L.
100–607, title VI, § 616(a), (b), 102 Stat. 3138, provided
general provisions.
A prior section 295g–10a, Pub. L. 100–607, title VI, § 633,
Nov. 4, 1988, 102 Stat. 3147, required with respect to the

§ 295f–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

application and award process for certain health personnel training programs the semiannual issuance of
solicitations for grant applications and the preliminary
review of applications for technical sufficiency, prior to
repeal by Pub. L. 102–408, title III, § 311, Oct. 13, 1992, 106
Stat. 2091.
A prior section 295g–11, act July 1, 1944, ch. 373, title
VII, § 790A, as added Nov. 4, 1988, Pub. L. 100–607, title
VI, § 617, 102 Stat. 3140, related to public health special
projects, prior to the general amendment of this subchapter by Pub. L. 102–408.
Another prior section 295g–11, act July 1, 1944, ch. 373,
title VII, § 785, as added Nov. 18, 1971, Pub. L. 92–157,
title I, § 106(b)(6), 85 Stat. 453; amended Oct. 12, 1976,
Pub. L. 94–484, title I, § 101(q), 90 Stat. 2245, provided
scholarship grants for study abroad, prior to repeal by
Pub. L. 94–484, title IV, § 409(a), Oct. 12, 1976, 90 Stat.
2290, effective Oct. 1, 1976.
Prior sections 295g–21 to 295g–23 were repealed by
Pub. L. 94–484, title IV, § 409(a), Oct. 12, 1976, 90 Stat.
2290, effective Oct. 1, 1976.
Section 295g–21, act July 1, 1944, ch. 373, title VII,
§ 784, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 106(c), 85 Stat. 455, provided scholarship grants in relation to physician shortage area scholarship program.
Section 295g–22, act July 1, 1944, ch. 373, title VII,
§ 785, as added Nov. 18, 1971, Pub. L. 92–157, title I,
§ 106(c), 85 Stat. 457, related to administration of and
contractual arrangements for implementation of the
physician shortage area scholarship program.
Section 295g–23, act July 1, 1944, ch. 373, title VII,
§ 786, as added Nov. 18, 1971 Pub. L. 92–157, title I,
§ 106(c), 85 Stat. 457; amended Apr. 22, 1976, Pub. L.
94–278, title XI, § 1104, 90 Stat. 416; Oct. 12, 1976, Pub. L.
94–484, title I, § 101(r), 90 Stat. 2246, authorized appropriations for physician shortage area scholarships in
amount of $2,500,000; $3,000,000; $3,500,000; $3,500,000; and
$2,000,000 for fiscal years ending June 30, 1972, through
1976, and for fiscal years ending Sept. 30, 1977, and
thereafter such sums necessary to continue making
grants to students who prior to July 1, 1976, received
grants and were eligible for grants during the succeeding fiscal year.
A prior section 295h, act July 1, 1944, ch. 373, title VII,
§ 791, as added Oct. 12, 1976, Pub. L. 94–484, title VII,
§ 701(a), 90 Stat. 2303; amended Oct. 17, 1979, Pub. L.
96–88, title III, § 301(a)(1), title V, § 507, 93 Stat. 677, 692;
Aug. 13, 1981, Pub. L. 97–35, title XXVII, § 2746(b)(1), 95
Stat. 927; Jan. 4, 1983, Pub. L. 97–414, § 8(k)(2), 96 Stat.
2061; Oct. 22, 1985, Pub. L. 99–129, title I, § 111, title II,
§ 219, 99 Stat. 524, 543; Nov. 4, 1988, Pub. L. 100–607, title
VI, § 618, 102 Stat. 3140; Nov. 18, 1988, Pub. L. 100–690,
title II, § 2615(f), 102 Stat. 4239; Aug. 16, 1989, Pub. L.
101–93, § 5(j), 103 Stat. 613, related to grants for graduate
programs in health administration, prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 295h, act July 1, 1944, ch. 373,
title VII, § 791, as added Nov. 3, 1966, Pub. L. 89–751, § 2,
80 Stat. 1222; amended Aug. 16, 1968, Pub. L. 90–490, title
III, § 301(a)(1), 82 Stat. 788; Nov. 2, 1970, Pub. L. 91–519,
title II, § 201, 84 Stat. 1344, provided for grants for construction of teaching facilities of allied health professions personnel, prior to the general amendment of this
part by Pub. L. 94–484.
A prior section 295h–1, act July 1, 1944, ch. 373, title
VII, § 792, as added Oct. 12, 1976, Pub. L. 94–484, title VII,
§ 701(a), 90 Stat. 2304; amended Nov. 10, 1978, Pub. L.
95–626, title I, § 121, 92 Stat. 3570; Sept. 29, 1979, Pub. L.
96–76, title II, § 206(b), 93 Stat. 583, related to special
projects for accredited schools of public health and
graduate programs in health administration, prior to
repeal by Pub. L. 97–35, title XXVII, § 2746(c), Aug. 13,
1981, 95 Stat. 927.
Another prior section 295h–1, act July 1, 1944, ch. 373,
title VII, § 792, as added Nov. 3, 1966, Pub. L. 89–751, § 2,
80 Stat. 1226; amended Aug. 16, 1968, Pub. L. 90–490, title
III, § 301(a)(2), 82 Stat. 788; Nov. 2, 1970, Pub. L. 91–519,
title II, § 202(a), (b), 84 Stat. 1344, 1345; June 18, 1973,
Pub. L. 93–45, title I, § 109(a), (b), 87 Stat. 93; Oct. 12,
1976, Pub. L. 94–484, title I, § 101(s)(1), (2), 90 Stat. 2246,

Page 826

provided for grants to improve quality of training centers for allied health professions, prior to the general
amendment of this part by Pub. L. 94–484.
Prior sections 295h–1a to 295h–2 were omitted in the
general amendment of this subchapter by Pub. L.
102–408.
Section 295h–1a, act July 1, 1944, ch. 373, title VII,
§ 791A, formerly § 749, as added Oct. 12, 1976, Pub. L.
94–484, title IV, § 408(a), 90 Stat. 2280; amended Aug. 1,
1977, Pub. L. 95–83, title III, § 307(f), 91 Stat. 391; Oct. 17,
1979, Pub. L. 96–88, title III, § 301(a)(1), title V, § 507, 93
Stat. 677, 692; renumbered § 791A and amended Aug. 13,
1981, Pub. L. 97–35, title XXVII, § 2746(b)(2), 95 Stat. 927;
Jan. 4, 1983, Pub. L. 97–414, § 8(k)(1), 96 Stat. 2061; Oct.
22, 1985, Pub. L. 99–129, title I, § 112, 99 Stat. 525; Nov. 4,
1988, Pub. L. 100–607, title VI, § 619, 102 Stat. 3140, related to traineeships for students in other graduate programs.
Section 295h–1b, act July 1, 1944, ch. 373, title VII,
§ 792; formerly § 748, as added Oct. 12, 1976, Pub. L.
94–484, title IV, § 408(a), 90 Stat. 2279; amended Aug. 1,
1977, Pub. L. 95–83, title III, § 307(f), 91 Stat. 391; Dec. 19,
1977, Pub. L. 95–215, § 3, 91 Stat. 1504; Sept. 29, 1979, Pub.
L. 96–76, title II, § 206(a), 93 Stat. 583; renumbered § 792
and amended Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2746(d), 95 Stat. 927; Oct. 22, 1985, Pub. L. 99–129, title
I, § 113, 99 Stat. 525; Nov. 4, 1988, Pub. L. 100–607, title VI,
§ 621, 102 Stat. 3141, related to traineeships for students
in schools of public health.
Section 295h–1c, act July 1, 1944, ch. 373, title VII,
§ 793, as added Aug. 13, 1981, Pub. L. 97–35, title XXVII,
§ 2746(f), 95 Stat. 928; amended Oct. 22, 1985, Pub. L.
99–129, title I, § 114, 99 Stat. 525; Nov. 4, 1988, Pub. L.
100–607, title VI, § 629(b)(2), 102 Stat. 3146, related to
training in preventive medicine.
Section 295h–2, act July 1, 1944, ch. 373, title VII, § 794,
formerly § 793, as added Oct. 12, 1976, Pub. L. 94–484, title
VII, § 701(a), 90 Stat. 2305; amended S. Res. No. 4, Feb.
4, 1977; Nov. 9, 1978, Pub. L. 95–623, § 12(g), 92 Stat. 3457;
S. Res. No. 30, Mar. 7, 1979; H. Res. No. 549, Mar. 25, 1980;
renumbered § 794, Aug. 13, 1981, Pub. L. 97–35, title
XXVII, § 2746(f), 95 Stat. 928, related to statistics and
annual report to Congress.
Another prior section 295h–2, act July 1, 1944, ch. 373,
title VII, § 793, as added Nov. 3, 1966, Pub. L. 89–751, § 2,
80 Stat. 1228; amended Aug. 16, 1968, Pub. L. 90–490, title
III, § 301(a)(3), 82 Stat. 788; Nov. 2, 1970, Pub. L. 91–519,
title II, § 203, 84 Stat. 1436; June 18, 1973, Pub. L. 93–45,
title I, § 109(c), 87 Stat. 93; Oct. 12, 1976, Pub. L. 94–484,
title I, § 101(s)(3), 90 Stat. 2246, provided traineeships for
advanced training of allied health professions personnel, including authorization of appropriations, prior to
the general amendment of this part by Pub. L. 94–484.
A prior section 295h–3, act July 1, 1944, ch. 373, title
VII, § 794, as added Nov. 3, 1966, Pub. L. 89–751, § 2, 80
Stat. 1228; amended Aug. 16, 1968, Pub. L. 90–490, title
III, § 301(a)(4), (b), 82 Stat. 788, authorized appropriations for grants to public or nonprofit private agencies,
institutions, and organizations for projects to develop,
demonstrate, or evaluate curriculums and methods for
the training of health technologists, prior to repeal by
Pub. L. 91–519, title II, § 202(d), Nov. 2, 1970, 84 Stat. 1345,
effective with respect to the fiscal year beginning July
1, 1970.
Prior sections 295h–3a to 295h–3d were omitted in the
general amendment of this part by Pub. L. 94–484.
Section 295h–3a, act July 1, 1944, ch. 373, title VII,
§ 794A, as added Nov. 2, 1970, Pub. L. 91–519, title II, § 204,
84 Stat. 1346; amended June 18, 1973, Pub. L. 93–45, title
I, § 109(d), 87 Stat. 93; Oct. 12, 1976, Pub. L. 94–484, title
I, § 101(s)(4), 90 Stat. 2246, provided for grants and contracts to encourage full utilization of educational talent for allied health professions and authorizing appropriations.
Section 295h–3b, act July 1, 1944, ch. 373, title VII,
§ 794B, as added Nov. 2, 1970, Pub. L. 91–519, title II, § 204,
84 Stat. 1346, provided for scholarship grants for training in allied health professions.
Section 295h–3c, act July 1, 1944, ch. 373, title VII,
§ 794C, as added Nov. 2, 1970, Pub. L. 91–519, title II, § 204,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

84 Stat. 1347, provided for work-study programs in
training in allied health professions.
Section 295h–3d, act July 1, 1944, ch. 373, title VII,
§ 794D, as added Nov. 2, 1970, Pub. L. 91–519, title II, § 204,
84 Stat. 1349; amended Nov. 18, 1971, Pub. L. 92–157, title
III, § 301(e), 85 Stat. 464, provided for loans for students
of allied health professions.
Prior sections 295h–4 to 295h–7 were omitted in the
general amendment of this subchapter by Pub. L.
102–408.
Section 295h–4, act July 1, 1944, ch. 373, title VII, § 795,
as added Oct. 12, 1976, Pub. L. 94–484, title VII, § 701(a),
90 Stat. 2306; amended Oct. 17, 1979, Pub. L. 96–88, title
III, § 301(a)(1), title V, § 507, 93 Stat. 677, 692, defined ‘‘allied health personnel’’, ‘‘training center for allied
health professions’’, and ‘‘nonprofit’’. See section 295p
of this title.
Another prior section 295h–4, act July 1, 1944, ch. 373,
title VII, § 795, as added Nov. 3, 1966, Pub. L. 89–751, § 2,
80 Stat. 1228; amended Dec. 5, 1967, Pub. L. 90–174, § 12(e),
81 Stat. 542; Nov. 2, 1970, Pub. L. 91–519, title II, § 202(c),
84 Stat. 1344; Nov. 18, 1971, Pub. L. 92–157, title III,
§ 301(f), 85 Stat. 464, defined ‘‘training center for allied
health professions’’; ‘‘full-time student’’; ‘‘nonprofit’’;
‘‘construction’’ and ‘‘cost of construction’’; and ‘‘affiliated hospital’’, prior to the general amendment of this
part by Pub. L. 94–484.
Section 295h–5, act July 1, 1944, ch. 373, title VII, § 796,
as added Oct. 12, 1976, Pub. L. 94–484, title VII, § 701(a),
90 Stat. 2307; amended Aug. 1, 1977, Pub. L. 95–83, title
III, § 307(l), (m), 91 Stat. 392; Nov. 4, 1988, Pub. L. 100–607,
title VI, § 624, 102 Stat. 3143; Nov. 18, 1988, Pub. L.
100–690, title II, § 2615(f) [(h)], 102 Stat. 4240, related to
project grants and contracts with eligible entities to
improve the effectiveness of allied health administration and practitioners. See section 294e of this title.
Another prior section 295h–5, act July 1, 1944, ch. 373,
title VII, § 796, as added Nov. 3, 1966, Pub. L. 89–751, § 2,
80 Stat. 1230, provided for keeping of records and audits
in relation to training in allied health professions,
prior to the general amendment of this part by Pub. L.
94–484.
Section 295h–6, act July 1, 1944, ch. 373, title VII, § 797,
as added Oct. 12, 1976, Pub. L. 94–484, title VII, § 701(a),
90 Stat. 2308; amended Nov. 4, 1988, Pub. L. 100–607, title
VI, § 625, 102 Stat. 3144, related to traineeships for advanced training of allied health personnel.
Another prior section 295h–6, act July 1, 1944, ch. 373,
title VII, § 797, as added Aug. 16, 1968, Pub. L. 90–490,
title III, § 301(c), 82 Stat. 788, authorized the use of up
to one-half of one per centum of appropriated funds for
evaluation of programs covered thereby, prior to repeal
by Pub. L. 91–296, title IV, § 401(b)(1)(E), June 30, 1970, 84
Stat. 352, effective with respect to appropriations for
fiscal years beginning after June 30, 1970.
Section 295h–7, act July 1, 1944, ch. 373, title VII, § 798,
as added Oct. 12, 1976, Pub. L. 94–484, title VII, § 701(a),
90 Stat. 2309, related to educational assistance to disadvantaged individuals in allied health training.
Another prior section 295h–7, act July 1, 1944, ch. 373,
title VII, § 798, as added Aug. 16, 1968, Pub. L. 90–490,
title III, § 301(d), 82 Stat. 788; amended Nov. 2, 1970, Pub.
L. 91–519, title II, § 205, 84 Stat. 1354, directed Secretary
to conduct a study of the allied health programs, prior
to the general amendment of this part by Pub. L.
94–484.
A prior section 295h–8, act July 1, 1944, ch. 373, title
VII, § 799, as added Nov. 2, 1970, Pub. L. 91–519, title II,
§ 206, 84 Stat. 1354; amended Nov. 18, 1971, Pub. L. 92–157,
title I, § 109, 85 Stat. 461, which related to advance funding, was renumbered section 703 of act July 1, 1944, by
Pub. L. 94–484 and transferred to section 292c of this
title.
A prior section 295h–9, act July 1, 1944, ch. 373, title
VII, § 799A, as added Nov. 2, 1970, Pub. L. 91–519, title II,
§ 207, 84 Stat. 1355, § 704; amended Nov. 18, 1971, Pub. L.
92–157, title I, § 110(2), 85 Stat. 461; July 12, 1974, Pub. L.
93–348, title I, § 105, 88 Stat. 347, which related to sexual
discrimination, was renumbered section 704 of act July
1, 1944, by Pub. L. 94–484 and transferred to section 292d
of this title.

§ 295j

A prior section 295i, act July 1, 1944, ch. 373, title VII,
§ 799, as added Apr. 7, 1986, Pub. L. 99–272, title XVII,
§ 17001, 100 Stat. 357; amended Oct. 25, 1988, Pub. L.
100–527, § 10(4), 102 Stat. 2641; Nov. 4, 1988, Pub. L.
100–607, title VI, §§ 627, 629(b)(1), 102 Stat. 3145, 3146; Aug.
16, 1989, Pub. L. 101–93, § 5(o)(3), 103 Stat. 614; Oct. 9, 1992,
Pub. L. 102–405, title III, § 302(e)(1), 106 Stat. 1985, established a Council on Graduate Medical Education, prior
to the general amendment of this subchapter by Pub.
L. 102–408. See section 294o of this title.

PART F—GENERAL PROVISIONS
AMENDMENTS
1998—Pub. L. 105–392, title I, § 106(a)(2)(A), Nov. 13,
1998, 112 Stat. 3557, redesignated part G as F.

§ 295j. Preferences and required information in
certain programs
(a) Preferences in making awards
(1) In general
Subject to paragraph (2), in making awards
of grants or contracts under any of sections
293k and 294 of this title, the Secretary shall
give preference to any qualified applicant
that—
(A) has a high rate for placing graduates in
practice settings having the principal focus
of serving residents of medically underserved communities;
(B) during the 2-year period preceding the
fiscal year for which such an award is
sought, has achieved a significant increase
in the rate of placing graduates in such settings; or
(C) utilizes a longitudinal evaluation (as
described in section 294n(d)(2) of this title)
and reports data from such system to the national workforce database (as established
under section 294n(b)(2)(E) of this title).
(2) Limitation regarding peer review
For purposes of paragraph (1), the Secretary
may not give an applicant preference if the
proposal of the applicant is ranked at or below
the 20th percentile of proposals that have been
recommended for approval by peer review
groups.
(b) ‘‘Graduate’’ defined
For purposes of this section, the term ‘‘graduate’’ means, unless otherwise specified, an individual who has successfully completed all training and residency requirements necessary for
full certification in the health profession selected by the individual.
(c) Exceptions for new programs
(1) In general
To permit new programs to compete equitably for funding under this section, those new
programs that meet at least 4 of the criteria
described in paragraph (3) shall qualify for a
funding preference under this section.
(2) Definition
As used in this subsection, the term ‘‘new
program’’ means any program that has graduated less than three classes. Upon graduating
at least three classes, a program shall have
the capability to provide the information necessary to qualify the program for the general
funding preferences described in subsection (a)
of this section.

§ 295k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Criteria
The criteria referred to in paragraph (1) are
the following:
(A) The mission statement of the program
identifies a specific purpose of the program
as being the preparation of health professionals to serve underserved populations.
(B) The curriculum of the program includes content which will help to prepare
practitioners to serve underserved populations.
(C) Substantial clinical training experience is required under the program in medically underserved communities.
(D) A minimum of 20 percent of the clinical faculty of the program spend at least 50
percent of their time providing or supervising care in medically underserved communities.
(E) The entire program or a substantial
portion of the program is physically located
in a medically underserved community.
(F) Student assistance, which is linked to
service in medically underserved communities following graduation, is available to
the students in the program.
(G) The program provides a placement
mechanism for deploying graduates to medically underserved communities.
(July 1, 1944, ch. 373, title VII, § 791, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2058; amended Pub. L. 102–531, title III,
§ 313(a)(5), Oct. 27, 1992, 106 Stat. 3507; Pub. L.
105–392, title I, §§ 106(a)(2)(B), 107, Nov. 13, 1998,
112 Stat. 3557, 3560; Pub. L. 111–148, title V,
§ 5103(c), Mar. 23, 2010, 124 Stat. 605.)
PRIOR PROVISIONS
A prior section 295j, act July 1, 1944, ch. 373, title VII,
§ 799A, as added Nov. 4, 1988, Pub. L. 100–607, title VI,
§ 637(a), 102 Stat. 3149; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2615(g)[(i)], 102 Stat. 4240; Aug. 16, 1989,
Pub. L. 101–93, § 5(n), 103 Stat. 613, related to grants and
contracts to provide health care in rural areas, prior to
the general amendment of this subchapter by Pub. L.
102–408.
Another prior section 295j, act July 1, 1944, ch. 373,
title VII, § 799A, as added Nov. 23, 1988, Pub. L. 100–713,
title VII, § 714, 102 Stat. 4834, relating to grants and contracts to provide health care in rural areas, prior to repeal by Pub. L. 100–607, title VI, § 637(b), Nov. 4, 1988, 102
Stat. 3151. Subsequently, section 637(b) of Pub. L.
100–607 was repealed by Pub. L. 101–93, § 5(n)(1), Aug. 16,
1989, 103 Stat. 613, and section 5(n)(2) of Pub. L. 101–93
amended this subchapter to read as if the amendment
made by section 714 of Pub. L. 100–713 had not been enacted.
A prior section 791 of act July 1, 1944, was classified
to section 295h of this title prior to the general amendment of this subchapter by Pub. L. 102–408.
AMENDMENTS
2010—Subsec. (a)(1)(C). Pub. L. 111–148 added subpar.
(C).
1998—Subsec. (a)(1). Pub. L. 105–392, § 107(b)(1), substituted ‘‘sections 293k and 294 of this title’’ for ‘‘sections 293k through 293o of this title, under section 294b
of this title, or under section 294d or 294e of this title’’
in introductory provisions.
Subsec. (a)(2). Pub. L. 105–392, § 107(b)(2), struck out
‘‘under section 295o(a) of this title’’ before period at
end.
Subsec. (b). Pub. L. 105–392, § 106(a)(2)(B), redesignated
subsec. (c) as (b) and struck out former subsec. (b)

Page 828

which required submission of certain information by
applicant.
Subsec. (c). Pub. L. 105–392, §§ 106(a)(2)(B)(ii), 107(a),
added subsec. (c) and redesignated former subsec. (c) as
(b).
1992—Subsec. (b). Pub. L. 102–531, in introductory provisions, inserted references to sections 294d and 294e of
this title and substituted reference to section 295o(f)(2)
of this title for reference to section 293p(a) of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–531 effective immediately
after enactment of Pub. L. 102–408, see section 313(c) of
Pub. L. 102–531, set out as a note under section 292y of
this title.
REQUIRED ASSURANCES REGARDING BLOODBORNE
DISEASES
Pub. L. 102–408, title III, § 308, Oct. 13, 1992, 106 Stat.
2089, provided that: ‘‘With respect to awards of grants
or contracts under title VII or VIII of the Public Health
Service Act [this subchapter or subchapter VI of this
chapter], the Secretary of Health and Human Services
may make such an award for the provision of traineeships only if the applicant for the award provides assurances satisfactory to the Secretary that all trainees
will, as appropriate, receive instruction in the utilization of universal precautions and infection control procedures for the prevention of the transmission of bloodborne diseases.’’

§ 295k. Health professions data
(a) In general
The Secretary shall establish a program, including a uniform health professions data reporting system, to collect, compile, and analyze
data on health professions personnel which program shall initially include data respecting all
physicians and dentists in the States. The Secretary is authorized to expand the program to
include, whenever he determines it necessary,
the collection, compilation, and analysis of data
respecting pharmacists, optometrists, podiatrists, veterinarians, public health personnel,
audiologists, speech pathologists, health care
administration personnel, nurses, allied health
personnel, medical technologists, chiropractors,
clinical psychologists, professional counselors,
and any other health personnel in States designated by the Secretary to be included in the
program. Such data shall include data respecting the training, licensure status (including permanent, temporary, partial, limited, or institutional), place or places of practice, professional
specialty, practice characteristics, place and
date of birth, sex, and socioeconomic background of health professions personnel and such
other demographic information regarding health
professions personnel as the Secretary may require.
(b) Certain authorities and requirements
(1) Sources of information
In carrying out subsection (a) of this section, the Secretary shall collect available information from appropriate local, State, and
Federal agencies and other appropriate
sources.
(2) Contracts for studies of health professions
The Secretary shall conduct or enter into
contracts for the conduct of analytic and descriptive studies of the health professions, including evaluations and projections of the sup-

Page 829

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ply of, and requirements for, the health professions by specialty and geographic location.
Such studies shall include studies determining
by specialty and geographic location the number of health professionals (including allied
health professionals and health care administration personnel) who are members of minority groups, including Hispanics, and studies
providing by specialty and geographic location
evaluations and projections of the supply of,
and requirements for, health professionals (including allied health professionals and health
care administration personnel) to serve minority groups, including Hispanics.
(3) Grants and contracts regarding States
The Secretary is authorized to make grants
and to enter into contracts with States (or an
appropriate nonprofit private entity in any
State) for the purpose of participating in the
program established under subsection (a) of
this section. The Secretary shall determine
the amount and scope of any such grant or
contract. To be eligible for a grant or contract
under this paragraph a State or entity shall
submit an application in such form and manner and containing such information as the
Secretary shall require. Such application shall
include reasonable assurance, satisfactory to
the Secretary, that—
(A) such State (or nonprofit entity within
a State) will establish a program of mandatory annual registration of the health professions personnel described in subsection (a)
of this section who reside or practice in such
State and of health institutions licensed by
such State, which registration shall include
such information as the Secretary shall determine to be appropriate;
(B) such State or entity shall collect such
information and report it to the Secretary in
such form and manner as the Secretary shall
prescribe; and
(C) such State or entity shall comply with
the requirements of subsection (e) of this
section.
(d) 1 Reports to Congress
The Secretary shall submit to the Congress on
October 1, 1993, and biennially thereafter, the
following reports:
(1) A comprehensive report regarding the
status of health personnel according to profession, including a report regarding the analytic
and descriptive studies conducted under this
section.
(2) A comprehensive report regarding applicants to, and students enrolled in, programs
and institutions for the training of health personnel, including descriptions and analyses of
student indebtedness, student need for financial assistance, financial resources to meet the
needs of students, student career choices such
as practice specialty and geographic location
and the relationship, if any, between student
indebtedness and career choices.
(e) Requirements regarding personal data
(1) In general
The Secretary and each program entity shall
in securing and maintaining any record of in1 So

in original. No subsec. (c) has been enacted.

§ 295k

dividually identifiable personal data (hereinafter in this subsection referred to as ‘‘personal data’’) for purposes of this section—
(A) inform any individual who is asked to
supply personal data whether he is legally
required, or may refuse, to supply such data
and inform him of any specific consequences,
known to the Secretary or program entity,
as the case may be, of providing or not providing such data;
(B) upon request, inform any individual if
he is the subject of personal data secured or
maintained by the Secretary or program entity, as the case may be, and make the data
available to him in a form comprehensible to
him;
(C) assure that no use is made of personal
data which use is not within the purposes of
this section unless an informed consent has
been obtained from the individual who is the
subject of such data; and
(D) upon request, inform any individual of
the use being made of personal data respecting such individual and of the identity of the
individuals and entities which will use the
data and their relationship to the programs
under this section.
(2) Consent as precondition to disclosure
Any entity which maintains a record of personal data and which receives a request from
the Secretary or a program entity for such
data for purposes of this section shall not
transfer any such data to the Secretary or to
a program entity unless the individual whose
personal data is to be so transferred gives an
informed consent for such transfer.
(3) Disclosure by Secretary
(A) Notwithstanding any other provision of
law, personal data collected by the Secretary
or any program entity under this section may
not be made available or disclosed by the Secretary or any program entity to any person
other than the individual who is the subject of
such data unless (i) such person requires such
data for purposes of this section, or (ii) in response to a demand for such data made by
means of compulsory legal process. Any individual who is the subject of personal data
made available or disclosed under clause (ii)
shall be notified of the demand for such data.
(B) Subject to all applicable laws regarding
confidentiality, only the data collected by the
Secretary under this section which is not personal data shall be made available to bona fide
researchers and policy analysts (including the
Congress) for the purposes of assisting in the
conduct of studies respecting health professions personnel.
(4) ‘‘Program entity’’ defined
For purposes of this subsection, the term
‘‘program entity’’ means any public or private
entity which collects, compiles, or analyzes
health professions data under a grant, contract, or other arrangement with the Secretary under this section.
(g) 2 Technical assistance
The Secretary shall provide technical assistance to the States and political subdivisions
2 So

in original. No subsec. (f) has been enacted.

§ 295l

TITLE 42—THE PUBLIC HEALTH AND WELFARE

thereof in the development of systems (including model laws) concerning confidentiality and
comparability of data collected pursuant to this
section.
(h) Grants and contracts regarding nonprofit entities
(1) In general
In carrying out subsection (a) of this section, the Secretary may make grants, or enter
into contracts and cooperative agreements
with, and provide technical assistance to, any
nonprofit entity in order to establish a uniform allied health professions data reporting
system to collect, compile, and analyze data
on the allied health professions personnel.
(2) Reports
With respect to reports required in subsection (d) of this section, each such report
made on or after October 1, 1991, shall include
a description and analysis of data collected
pursuant to paragraph (1).
(July 1, 1944, ch. 373, title VII, § 792, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2058; amended Pub. L. 105–392, title I,
§ 106(b), Nov. 13, 1998, 112 Stat. 3559.)
PRIOR PROVISIONS
A prior section 792 of act July 1, 1944, was classified
to section 295h–1b of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 792 of act July 1, 1944, was classified to section 295h–1 of this title prior to repeal by
Pub. L. 97–35.
AMENDMENTS
1998—Subsec. (a). Pub. L. 105–392 inserted ‘‘professional counselors,’’ after ‘‘clinical psychologists,’’.
STUDY REGARDING SHORTAGES OF LICENSED
PHARMACISTS
Pub. L. 106–129, § 5, Dec. 6, 1999, 113 Stat. 1675, provided
that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services (in this section referred to as the ‘Secretary’), acting through the appropriate agencies of the
Public Health Service, shall conduct a study to determine whether and to what extent there is a shortage of
licensed pharmacists. In carrying out the study, the
Secretary shall seek the comments of appropriate public and private entities regarding any such shortage.
‘‘(b) REPORT TO CONGRESS.—Not later than 1 year
after the date of the enactment of this Act [Dec. 6,
1999], the Secretary shall complete the study under subsection (a) and submit to the Congress a report that describes the findings made through the study and that
contains a summary of the comments received by the
Secretary pursuant to such subsection.’’
ADVISORY COUNCIL ON GRADUATE MEDICAL EDUCATION
Section 301 of Pub. L. 102–408, as amended by Pub. L.
102–531, title III, § 313(b), Oct. 27, 1992, 106 Stat. 3507;
Pub. L. 105–392, title I, § 104(b)(1)–(3), Nov. 13, 1998, 112
Stat. 3552, which was formerly set out as a note under
this section, was renumbered section 762 of the Public
Health Service Act by Pub. L. 105–392, title I,
§ 104(b)(4)–(6), Nov. 13, 1998, 112 Stat. 3553, and is classified to section 294o of this title.
COMMISSION ON ALLIED HEALTH
Section 302 of Pub. L. 102–408 provided for establishment of a National Commission on Allied Health,
charged with (1) making recommendations to the Secretary of Health and Human Services and Congress

Page 830

with respect to nationwide supply and distribution of
allied health personnel, current and future shortages of
personnel, priority research needs within allied health
professions, Federal policies relating to personnel and
research as well as undergraduate and graduate financing, concerted efforts on part of allied health facilities
and educational institutions to address such matters,
and needs with respect to nationwide data bases concerning supply and distribution of allied health personnel, and (2) encouraging entities providing allied health
education to voluntarily achieve recommendations of
Commission, and further provided for composition of
Commission, date certain for appointments to Commission, resources for Commission activities, an interim
progress report due not later than Oct. 1, 1993, a final
report due not later than Apr. 1, 1994, and termination
of Commission 60 days after submission of final report.
STUDY REGARDING SHORTAGE OF CLINICAL LABORATORY
TECHNOLOGISTS FOR MEDICALLY UNDERSERVED AND
RURAL COMMUNITIES
Section 303 of Pub. L. 102–408 directed Secretary of
Health and Human Services, with respect to the shortage of clinical laboratory technologists, to conduct a
study for the purpose of determining whether there are
special or unique factors affecting the supply of clinical
laboratory technologists in medically underserved and
rural communities, and assessing alternative routes for
certification of the competence of individuals to serve
as such technologists, with consideration of the role of
entities providing such certifications, and, not later
than Oct. 1, 1993, complete the study and submit to
Committee on Energy and Commerce of House of Representatives, and to Committee on Labor and Human
Resources of Senate, a report describing the findings
made as result of the study.
NATIONAL ADVISORY COUNCIL ON MEDICAL LICENSURE
Section 307 of Pub. L. 102–408 directed Secretary of
Health and Human Services to establish National Advisory Council on Medical Licensure to advise Secretary
on American Medical Association’s system of verifying
and maintaining information regarding qualifications
of individuals to practice medicine, as well as advice
regarding establishment and operation of any similar
system, provided for activities of Council, including review of private credentials verification system and recommendations on how it could be improved, as well as
review of State procedures for licensing individuals licensed in other States and procedures for licensing
international medical graduates, provided for composition of Council and appointment of members, required
submission of an interim report to Congress not later
than Sept. 30, 1993, and a final report with recommendations not later than Sept. 30, 1995, provided for
termination of Council not later than Sept. 30, 1995, or
upon submission of final report, whichever is earlier,
and further directed Secretary, in cooperation with
Council to submit to Congress, not later than Sept. 30,
1994, study of not less than 10 States for purposes of determining average time required for States to process
licensure applications of domestic and international
medical graduates as well as percentages of domestic
and international licensure applications approved.

§ 295l. Repealed. Pub. L. 105–392, title
§ 106(a)(2)(C), Nov. 13, 1998, 112 Stat. 3557

I,

Section, act July 1, 1944, ch. 373, title VII, § 793, as
added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106 Stat.
2061; amended Pub. L. 102–531, title III, § 313(a)(6), Oct.
27, 1992, 106 Stat. 3507, required development, publication, dissemination, and biennial report to Congress on
statistics respecting public and community health personnel.
A prior section 793 of act July 1, 1944, was classified
to section 295h–1c of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 793 of act July 1, 1944, was renumbered section 794 by Pub. L. 97–35 and classified to
section 295h–2 of this title.

Page 831

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 295m. Prohibition against discrimination on
basis of sex
The Secretary may not make a grant, loan
guarantee, or interest subsidy payment under
this subchapter to, or for the benefit of, any
school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, pharmacy, podiatric medicine, or public health or
any training center for allied health personnel,
or graduate program in clinical psychology, unless the application for the grant, loan guarantee, or interest subsidy payment contains assurances satisfactory to the Secretary that the
school or training center will not discriminate
on the basis of sex in the admission of individuals to its training programs. The Secretary
may not enter into a contract under this subchapter with any such school or training center
unless the school, training center, or graduate
program furnishes assurances satisfactory to the
Secretary that it will not discriminate on the
basis of sex in the admission of individuals to its
training programs. In the case of a school of
medicine which—
(1) on October 13, 1992, is in the process of
changing its status as an institution which admits only female students to that of an institution which admits students without regard
to their sex, and
(2) is carrying out such change in accordance
with a plan approved by the Secretary,
the provisions of the preceding sentences of this
section shall apply only with respect to a grant,
contract, loan guarantee, or interest subsidy to,
or for the benefit of such a school for a fiscal
year beginning after June 30, 1979.
(July 1, 1944, ch. 373, title VII, § 794, as added
Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106
Stat. 2063.)
PRIOR PROVISIONS
A prior section 794 of act July 1, 1944, was classified
to section 295h–2 of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 794 of act July 1, 1944, was classified to section 294h–3 of this title prior to repeal by
Pub. L. 91–519.

§ 295n. Repealed. Pub. L. 105–392, title
§ 101(b)(1), Nov. 13, 1998, 112 Stat. 3537

I,

Section, act July 1, 1944, ch. 373, title VII, § 795, as
added Pub. L. 102–408, title I, § 102, Oct. 13, 1992, 106 Stat.
2063; amended Pub. L. 102–531, title III, § 313(a)(7), Oct.
27, 1992, 106 Stat. 3507, related to obligated service regarding certain programs.
A prior section 795 of act July 1, 1944, was classified
to section 295h–4 of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 795 of act July 1, 1944, was classified to section 295h–4 of this title prior to the general
amendment of part G of this subchapter by Pub. L.
94–484.
SAVINGS PROVISION
Pub. L. 105–392, title I, § 101(b)(2), Nov. 13, 1998, 112
Stat. 3537, provided that: ‘‘The amendments made by
this section [enacting sections 293 to 293d of this title,
amending section 287a–2 of this title, and repealing this
section and former sections 293 to 293d of this title]
shall not be construed to terminate agreements that,
on the day before the date of enactment of this Act
[Nov. 13, 1998], are in effect pursuant to section 795 of

§ 295n–2

the Public Health Service Act (42 U.S.C. 795 [295n]) as
such section existed on such date. Such agreements
shall continue in effect in accordance with the terms of
the agreements. With respect to compliance with such
agreements, any period of practice as a provider of primary health services shall be counted towards the satisfaction of the requirement of practice pursuant to
such section 795.’’

§ 295n–1. Application
(a) In general
To be eligible to receive a grant or contract
under this subchapter, an eligible entity shall
prepare and submit to the Secretary an application that meets the requirements of this section, at such time, in such manner, and containing such information as the Secretary may require.
(b) Plan
An application submitted under this section
shall contain the plan of the applicant for carrying out a project with amounts received under
this subchapter. Such plan shall be consistent
with relevant Federal, State, or regional health
professions program plans.
(c) Performance outcome standards
An application submitted under this section
shall contain a specification by the applicant
entity of performance outcome standards that
the project to be funded under the grant or contract will be measured against. Such standards
shall address relevant health workforce needs
that the project will meet. The recipient of a
grant or contract under this section shall meet
the standards set forth in the grant or contract
application.
(d) Linkages
An application submitted under this section
shall contain a description of the linkages with
relevant educational and health care entities,
including training programs for other health
professionals as appropriate, that the project to
be funded under the grant or contract will establish. To the extent practicable, grantees under
this section shall establish linkages with health
care providers who provide care for underserved
communities and populations.
(July 1, 1944, ch. 373, title VII, § 796, as added
Pub. L. 105–392, title I, § 106(a)(2)(F), Nov. 13,
1998, 112 Stat. 3557.)
§ 295n–2. Use of funds
(a) In general
Amounts provided under a grant or contract
awarded under this subchapter may be used for
training program development and support, faculty development, model demonstrations, trainee support including tuition, books, program
fees and reasonable living expenses during the
period of training, technical assistance, workforce analysis, dissemination of information,
and exploring new policy directions, as appropriate to meet recognized health workforce objectives, in accordance with this subchapter.
(b) Maintenance of effort
With respect to activities for which a grant
awarded under this subchapter is to be ex-

§ 295o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

pended, the entity shall agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level
of such expenditures maintained by the entity
for the fiscal year preceding the fiscal year for
which the entity receives such a grant.
(July 1, 1944, ch. 373, title VII, § 797, as added
Pub. L. 105–392, title I, § 106(a)(2)(F), Nov. 13,
1998, 112 Stat. 3557.)
§ 295o. Matching requirement
The Secretary may require that an entity that
applies for a grant or contract under this subchapter provide non-Federal matching funds, as
appropriate, to ensure the institutional commitment of the entity to the projects funded under
the grant. As determined by the Secretary, such
non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or
services.
(July 1, 1944, ch. 373, title VII, § 798, as added
Pub. L. 105–392, title I, § 106(a)(2)(F), Nov. 13,
1998, 112 Stat. 3558.)
PRIOR PROVISIONS
A prior section 295o, act July 1, 1944, ch. 373, title VII,
§ 798, as added Pub. L. 102–408, title I, § 102, Oct. 13, 1992,
106 Stat. 2064; amended Pub. L. 102–531, title III,
§ 313(a)(8), Oct. 27, 1992, 106 Stat. 3507, set forth certain
general provisions relating to this subchapter, prior to
repeal by Pub. L. 105–392, title I, § 106(a)(2)(D), Nov. 13,
1998, 112 Stat. 3557.
A prior section 798 of act July 1, 1944, was classified
to section 295h–7 of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.
Another prior section 798 of act July 1, 1944, was classified to section 295h–7 of this title prior to the general
amendment of part G of this subchapter by Pub. L.
94–484.

§ 295o–1. Generally applicable provisions
(a) Awarding of grants and contracts
The Secretary shall ensure that grants and
contracts under this subchapter are awarded on
a competitive basis, as appropriate, to carry out
innovative demonstration projects or provide for
strategic workforce supplementation activities
as needed to meet health workforce goals and in
accordance with this subchapter. Contracts may
be entered into under this subchapter with public or private entities as may be necessary.
(b) Eligible entities
Unless specifically required otherwise in this
subchapter, the Secretary shall accept applications for grants or contracts under this subchapter from health professions schools, academic health centers, State or local governments, or other appropriate public or private
nonprofit entities for funding and participation
in health professions and nursing training activities. The Secretary may accept applications
from for-profit private entities if determined appropriate by the Secretary.
(c) Information requirements
(1) In general
Recipients of grants and contracts under
this subchapter shall meet information requirements as specified by the Secretary.

Page 832

(2) Data collection
The Secretary shall establish procedures to
ensure that, with respect to any data collection required under this subchapter, such data
is collected in a manner that takes into account age, sex, race, and ethnicity.
(3) Use of funds
The Secretary shall establish procedures to
permit the use of amounts appropriated under
this subchapter to be used for data collection
purposes.
(4) Evaluations
The Secretary shall establish procedures to
ensure the annual evaluation of programs and
projects operated by recipients of grants or
contracts under this subchapter. Such procedures shall ensure that continued funding for
such programs and projects will be conditioned upon a demonstration that satisfactory
progress has been made by the program or
project in meeting the objectives of the program or project.
(d) Training programs
Training programs conducted with amounts
received under this subchapter shall meet applicable accreditation and quality standards.
(e) Duration of assistance
(1) In general
Subject to paragraph (2), in the case of an
award to an entity of a grant, cooperative
agreement, or contract under this subchapter,
the period during which payments are made to
the entity under the award may not exceed 5
years. The provision of payments under the
award shall be subject to annual approval by
the Secretary of the payments and subject to
the availability of appropriations for the fiscal
year involved to make the payments. This
paragraph may not be construed as limiting
the number of awards under the program involved that may be made to the entity.
(2) Limitation
In the case of an award to an entity of a
grant, cooperative agreement, or contract
under this subchapter, paragraph (1) shall
apply only to the extent not inconsistent with
any other provision of this subchapter that relates to the period during which payments
may be made under the award.
(f) Peer review regarding certain programs
(1) In general
Each application for a grant under this subchapter, except any scholarship or loan program, including those under sections 1 292,
292q, or 292s of this title, shall be submitted to
a peer review group for an evaluation of the
merits of the proposals made in the application. The Secretary may not approve such an
application unless a peer review group has recommended the application for approval.
(2) Composition
Each peer review group under this subsection shall be composed principally of indi1 So

in original. Probably should be ‘‘section’’.

Page 833

TITLE 42—THE PUBLIC HEALTH AND WELFARE

viduals who are not officers or employees of
the Federal Government. In providing for the
establishment of peer review groups and procedures, the Secretary shall ensure sex, racial,
ethnic, and geographic balance among the
membership of such groups.
(3) Administration
This subsection shall be carried out by the
Secretary acting through the Administrator of
the Health Resources and Services Administration.
(g) Preference or priority considerations
In considering a preference or priority for
funding which is based on outcome measures for
an eligible entity under this subchapter, the
Secretary may also consider the future ability
of the eligible entity to meet the outcome preference or priority through improvements in the
eligible entity’s program design.
(h) Analytic activities
The Secretary shall ensure that—
(1) cross-cutting workforce analytical activities are carried out as part of the workforce
information and analysis activities under section 294n of this title; and
(2) discipline-specific workforce information
and analytical activities are carried out as
part of—
(A) the community-based linkage program
under part D of this subchapter; and
(B) the health workforce development program under subpart 2 of part E of this subchapter.
(i) Osteopathic Schools
For purposes of this subchapter, any reference
to—
(1) medical schools shall include osteopathic
medical schools; and
(2) medical students shall include osteopathic medical students.
(July 1, 1944, ch. 373, title VII, § 799, as added
Pub. L. 105–392, title I, § 106(a)(2)(F), Nov. 13,
1998, 112 Stat. 3558.)
PRIOR PROVISIONS
A prior section 799 of act July 1, 1944, was renumbered
section 799B by Pub. L. 105–392 and classified to section
295p of this title.
Another prior section 799 of act July 1, 1944, was classified to section 295i of this title prior to the general
amendment of this subchapter by Pub. L. 102–408.

§ 295o–2. Technical assistance
Funds appropriated under this subchapter may
be used by the Secretary to provide technical assistance in relation to any of the authorities
under this subchapter.
(July 1, 1944, ch. 373, title VII, § 799A, as added
Pub. L. 105–392, title I, § 106(a)(2)(F), Nov. 13,
1998, 112 Stat. 3559.)
§ 295p. Definitions
For purposes of this subchapter:
(1)(A) The terms ‘‘school of medicine’’,
‘‘school of dentistry’’, ‘‘school of osteopathic
medicine’’, ‘‘school of pharmacy’’, ‘‘school of
optometry’’, ‘‘school of podiatric medicine’’,

§ 295p

‘‘school of veterinary medicine’’, ‘‘school of
public health’’, and ‘‘school of chiropractic’’
mean an accredited public or nonprofit private
school in a State that provides training leading, respectively, to a degree of doctor of medicine, a degree of doctor of dentistry or an
equivalent degree, a degree of doctor of osteopathy, a degree of bachelor of science in
pharmacy or an equivalent degree or a degree
of doctor of pharmacy or an equivalent degree,
a degree of doctor of optometry or an equivalent degree, a degree of doctor of podiatric
medicine or an equivalent degree, a degree of
doctor of veterinary medicine or an equivalent
degree, a graduate degree in public health or
an equivalent degree, and a degree of doctor of
chiropractic or an equivalent degree, and including advanced training related to such
training provided by any such school.
(B) The terms ‘‘graduate program in health
administration’’ and ‘‘graduate program in
clinical psychology’’ mean an accredited graduate program in a public or nonprofit private
institution in a State that provides training
leading, respectively, to a graduate degree in
health administration or an equivalent degree
and a doctoral degree in clinical psychology or
an equivalent degree.
(C) The terms ‘‘graduate program in clinical
social work’’ and ‘‘graduate program in marriage and family therapy’’ and ‘‘graduate program in professional counseling’’ mean an accredited graduate program in a public or nonprofit private institution in a State that provides training, respectively, in a concentration in health or mental health care leading to
a graduate degree in social work and a concentration leading to a graduate degree in
marriage and family therapy and a concentration leading to a graduate degree in counseling.
(D) The term ‘‘graduate program in behavioral health and mental health practice’’
means a graduate program in clinical psychology, behavioral health and mental health
practice, clinical social work, professional
counseling, or marriage and family therapy.
(E) The term ‘‘accredited’’, when applied to
a school of medicine, osteopathic medicine,
dentistry, veterinary medicine, optometry, podiatry, pharmacy, public health, or chiropractic, or a graduate program in health administration, clinical psychology, clinical social
work, professional counseling, or marriage and
family therapy, means a school or program
that is accredited by a recognized body or bodies approved for such purpose by the Secretary
of Education, except that a new school or program that, by reason of an insufficient period
of operation, is not, at the time of application
for a grant or contract under this subchapter,
eligible for accreditation by such a recognized
body or bodies, shall be deemed accredited for
purposes of this subchapter, if the Secretary of
Education finds, after consultation with the
appropriate accreditation body or bodies, that
there is reasonable assurance that the school
or program will meet the accreditation standards of such body or bodies prior to the beginning of the academic year following the normal graduation date of the first entering class
in such school or program.

§ 295p

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) The term ‘‘teaching facilities’’ means
areas dedicated for use by students, faculty, or
administrative or maintenance personnel for
clinical purposes, research activities, libraries,
classrooms, offices, auditoriums, dining areas,
student activities, or other related purposes
necessary for, and appropriate to, the conduct
of comprehensive programs of education. Such
term includes interim facilities but does not
include off-site improvements or living quarters.
(3) PHYSICIAN ASSISTANT EDUCATION PROGRAM.—The term ‘‘physician assistant education program’’ means an educational program in a public or private institution in a
State that—
(A) has as its objective the education of individuals who, upon completion of their
studies in the program, be 1 qualified to provide primary care medical services with the
supervision of a physician; and
(B) is accredited by the Accreditation Review Commission on Education for the Physician Assistant.
(4) The term ‘‘school of allied health’’ means
a public or nonprofit private college, junior
college, or university or hospital-based educational entity that—
(A) provides, or can provide, programs of
education to enable individuals to become
allied health professionals or to provide additional training for allied health professionals;
(B) provides training for not less than a
total of twenty persons in the allied health
curricula (except that this subparagraph
shall not apply to any hospital-based educational entity);
(C) includes or is affiliated with a teaching
hospital; and
(D) is accredited by a recognized body or
bodies approved for such purposes by the
Secretary of Education, or which provides to
the Secretary satisfactory assurance by such
accrediting body or bodies that reasonable
progress is being made toward accreditation.
(5) The term ‘‘allied health professionals’’
means a health professional (other than a registered nurse or physician assistant)—
(A) who has received a certificate, an associate’s degree, a bachelor’s degree, a master’s degree, a doctoral degree, or postbaccalaureate training, in a science relating to
health care;
(B) who shares in the responsibility for the
delivery of health care services or related
services, including—
(i) services relating to the identification,
evaluation, and prevention of disease and
disorders;
(ii) dietary and nutrition services;
(iii) health promotion services;
(iv) rehabilitation services; or
(v) health systems management services;
and
(C) who has not received a degree of doctor
of medicine, a degree of doctor of osteopathy, a degree of doctor of dentistry or an
1 So

in original. Probably should be ‘‘will be’’.

Page 834

equivalent degree, a degree of doctor of veterinary medicine or an equivalent degree, a
degree of doctor of optometry or an equivalent degree, a degree of doctor of podiatric
medicine or an equivalent degree, a degree of
bachelor of science in pharmacy or an equivalent degree, a degree of doctor of pharmacy
or an equivalent degree, a graduate degree in
public health or an equivalent degree, a degree of doctor of chiropractic or an equivalent degree, a graduate degree in health administration or an equivalent degree, a doctoral degree in clinical psychology or an
equivalent degree, or a degree in social work
or an equivalent degree or a degree in counseling or an equivalent degree.
(6) The term ‘‘medically underserved community’’ means an urban or rural area or population that—
(A) is eligible for designation under section 254e of this title as a health professional
shortage area;
(B) is eligible to be served by a migrant
health center under section 254b 2 of this
title, a community health center under section 254c 2 of this title, a grantee under section 254b(h) of this title (relating to homeless individuals), or a grantee under section
256a 2 of this title (relating to residents of
public housing);
(C) has a shortage of personal health services, as determined under criteria issued by
the Secretary under section 1395x(aa)(2) of
this title (relating to rural health clinics);
or
(D) is designated by a State Governor (in
consultation with the medical community)
as a shortage area or medically underserved
community.
(7) The term ‘‘Department’’ means the Department of Health and Human Services.
(8) The term ‘‘nonprofit’’ refers to the status
of an entity owned and operated by one or
more corporations or associations no part of
the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual.
(9) The term ‘‘State’’ includes, in addition to
the several States, only the District of Columbia, the Commonwealth of Puerto Rico, the
Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American
Samoa, and the Trust Territory of the Pacific
Islands.
(10)(A) Subject to subparagraph (B), the
term ‘‘underrepresented minorities’’ means,
with respect to a health profession, racial and
ethnic populations that are underrepresented
in the health profession relative to the number of individuals who are members of the population involved.
(B) For purposes of subparagraph (A), Asian
individuals shall be considered by the various
subpopulations of such individuals.
(11) The term ‘‘psychologist’’ means an individual who—
(A) holds a doctoral degree in psychology;
and
2 See

References in Text notes below.

Page 835

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) is licensed or certified on the basis of
the doctoral degree in psychology, by the
State in which the individual practices, at
the independent practice level of psychology
to furnish diagnostic, assessment, preventive, and therapeutic services directly to individuals.
(12) AREA HEALTH EDUCATION CENTER.—The
term ‘‘area health education center’’ means a
public or nonprofit private organization that
has a cooperative agreement or contract in effect with an entity that has received an award
under subsection (a)(1) or (a)(2) of section 294a
of this title, satisfies the requirements in section 294a(d)(1) of this title, and has as one of
its principal functions the operation of an area
health education center. Appropriate organizations may include hospitals, health organizations with accredited primary care training
programs, accredited physician assistant educational programs associated with a college or
university, and universities or colleges not operating a school of medicine or osteopathic
medicine.
(13) AREA HEALTH EDUCATION CENTER PROGRAM.—The term ‘‘area health education center program’’ means 3 cooperative program
consisting of an entity that has received an
award under subsection (a)(1) or (a)(2) of section 294a of this title for the purpose of planning, developing, operating, and evaluating an
area health education center program and one
or more area health education centers, which
carries out the required activities described in
section 294a(c) of this title, satisfies the program requirements in such section,4 has as one
of its principal functions identifying and implementing strategies and activities that address health care workforce needs in its service area, in coordination with the local workforce investment boards.
(14) CLINICAL SOCIAL WORKER.—The term
‘‘clinical social worker’’ has the meaning
given the term in section 1395x(hh)(1) of this
title.
(15) CULTURAL COMPETENCY.—The term ‘‘cultural competency’’ shall be defined by the Secretary in a manner consistent with section
300u–6(d)(3) of this title.
(16) DIRECT CARE WORKER.—The term ‘‘direct
care worker’’ has the meaning given that term
in the 2010 Standard Occupational Classifications of the Department of Labor for Home
Health Aides [31–1011], Psychiatric Aides
[31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
(17) FEDERALLY QUALIFIED HEALTH CENTER.—
The term ‘‘Federally qualified health center’’
has the meaning given that term in section
1395x(aa) of this title.
(18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.—The term ‘‘frontier health professional shortage area’’ means an area—
(A) with a population density less than 6
persons per square mile within the service
area; and
(B) with respect to which the distance or
time for the population to access care is excessive.
3 So
4 So

in original. The word ‘‘a’’ probably should appear.
in original. The word ‘‘and’’ probably should appear.

§ 295p

(19) GRADUATE PSYCHOLOGY.—The term
‘‘graduate psychology’’ means an accredited
program in professional psychology.
(20) HEALTH DISPARITY POPULATION.—The
term ‘‘health disparity population’’ has the
meaning
given
such
term
in
section
299a–1(d)(1) of this title.
(21) HEALTH LITERACY.—The term ‘‘health
literacy’’ means the degree to which an individual has the capacity to obtain, communicate, process, and understand health information and services in order to make appropriate health decisions.
(22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an individual with a graduate or postgraduate degree from an accredited institution of higher education in psychiatry, psychology, school psychology, behavioral pediatrics, psychiatric nursing, social
work, school social work, substance abuse disorder prevention and treatment, marriage and
family counseling, school counseling, or professional counseling.
(23) ONE-STOP DELIVERY SYSTEM CENTER.—
The term ‘‘one-stop delivery system’’ means a
one-stop delivery system described in section
2864(c) of title 29.
(24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term
‘‘paraprofessional child and adolescent mental
health worker’’ means an individual who is
not a mental or behavioral health service professional, but who works at the first stage of
contact with children and families who are
seeking mental or behavioral health services,
including substance abuse prevention and
treatment services.
(25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETHNIC MINORITY POPULATION.—The
terms ‘‘racial and ethnic minority group’’ and
‘‘racial and ethnic minority population’’ have
the meaning given the term ‘‘racial and ethnic
minority group’’ in section 300u–6 of this title.
(26) RURAL HEALTH CLINIC.—The term ‘‘rural
health clinic’’ has the meaning given that
term in section 1395x(aa) of this title.
(July 1, 1944, ch. 373, title VII, § 799B, formerly
§ 799, as added Pub. L. 102–408, title I, § 102, Oct.
13, 1992, 106 Stat. 2066; renumbered § 799B and
amended Pub. L. 105–392, title I, §§ 106(a)(2)(E),
108, Nov. 13, 1998, 112 Stat. 3557, 3560; Pub. L.
107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1664; Pub. L. 111–148, title V, § 5002(b), Mar. 23,
2010, 124 Stat. 590.)
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing and the reference to section 254c of this
title, referred to in par. (6)(B), were in the original references to sections 329 and 330, meaning sections 329
and 330 of act July 1, 1944, which were omitted in the
general amendment of subpart I (§ 254b et seq.) of part
D of subchapter II of this chapter by Pub. L. 104–299, § 2,
Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub.
L. 104–299 enacted new sections 330 and 330A of act July
1, 1944, which are classified, respectively, to sections
254b and 254c of this title.
Section 256a of this title, referred to in par. (6)(B),
was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996,
110 Stat. 3645.

§ 296

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2010—Par. (3). Pub. L. 111–148, § 5002(b)(1), added par.
(3) and struck out former par. (3) which defined ‘‘program for the training of physician assistants’’ by describing its objective, duration, minimum enrollment,
and specific areas of instruction.
Pars. (12) to (26). Pub. L. 111–148, § 5002(b)(2), added
pars. (12) to (26).
2002—Par. (6)(B). Pub. L. 107–251 substituted ‘‘254b(h)’’
for ‘‘256’’.
1998—Par. (1)(C). Pub. L. 105–392, § 108(b)(1)(A), inserted ‘‘and ‘graduate program in professional counseling’ ’’ before ‘‘mean an’’ and ‘‘and a concentration leading to a graduate degree in counseling’’ before period at
end.
Par. (1)(D). Pub. L. 105–392, § 108(a), (b)(1)(B), inserted
‘‘behavioral health and’’ before ‘‘mental’’, ‘‘behavioral
health and mental health practice,’’ before ‘‘clinical’’,
and ‘‘professional counseling,’’ after ‘‘social work,’’.
Par. (1)(E). Pub. L. 105–392, § 108(b)(1)(C), inserted
‘‘professional counseling,’’ after ‘‘social work,’’.
Par. (3). Pub. L. 105–392, § 108(d), amended par. (3) generally. Prior to amendment, par. (3) read as follows:
‘‘The term ‘program for the training of physician assistants’ means an educational program that—
‘‘(A) has as its objective the education of individuals who will, upon completion of their studies in the
program, be qualified to provide primary health care
under the supervision of a physician; and
‘‘(B) meets regulations prescribed by the Secretary
in accordance with section 293n(b) of this title.’’
Par. (5)(C). Pub. L. 105–392, § 108(b)(2), inserted ‘‘or a
degree in counseling or an equivalent degree’’ before
period at end.
Par. (6)(D). Pub. L. 105–392, § 108(c), added subpar. (D).
Par. (11). Pub. L. 105–392, § 108(e), added par. (11).
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.

SUBCHAPTER VI—NURSING WORKFORCE
DEVELOPMENT
AMENDMENTS
1998—Pub. L. 105–392, title I, § 123(1), Nov. 13, 1998, 112
Stat. 3562, added subchapter VI heading and struck out
former subchapter VI heading ‘‘NURSE EDUCATION’’.
1985—Pub. L. 99–92, § 9(b)(3), Aug. 16, 1985, 99 Stat. 400,
substituted ‘‘NURSE EDUCATION’’ for ‘‘NURSE
TRAINING’’ in subchapter VI heading.

PART A—GENERAL PROVISIONS
AMENDMENTS
1998—Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3563, added part A heading and struck out former
part A heading ‘‘Special Projects’’.
1985—Pub. L. 99–92, § 9(b)(1), (2), Aug. 16, 1985, 99 Stat.
400, substituted ‘‘Special Projects’’ for ‘‘Assistance for
Expansion and Improvement of Nurse Training’’ as part
A heading, and struck out headings for subparts I, II,
III, and IV of part A which read as follows: ‘‘Subpart I—
Construction Assistance’’, ‘‘Subpart II—Capitation
Grants’’, ‘‘Subpart III—Financial Distress Grants’’, and
‘‘Subpart IV—Special Projects’’.

§ 296. Definitions
As used in this subchapter:

Page 836

(1) Eligible entities
The term ‘‘eligible entities’’ means schools
of nursing, nursing centers, academic health
centers, State or local governments, and other
public or private nonprofit entities determined
appropriate by the Secretary that submit to
the Secretary an application in accordance
with section 296a of this title.
(2) School of nursing
The term ‘‘school of nursing’’ means an accredited (as defined in paragraph 6) collegiate,
associate degree, or diploma school of nursing
in a State where graduates are—
(A) authorized to sit for the National
Council Licensure EXamination-Registered
Nurse (NCLEX–RN); or
(B) licensed registered nurses who will receive a graduate or equivalent degree or
training to become an advanced education
nurse as defined by section 296j(b) of this
title.
(3) Collegiate school of nursing
The term ‘‘collegiate school of nursing’’
means a department, division, or other administrative unit in a college or university which
provides primarily or exclusively a program of
education in professional nursing and related
subjects leading to the degree of bachelor of
arts, bachelor of science, bachelor of nursing,
or to an equivalent degree, or to a graduate
degree in nursing, or to an equivalent degree,
and including advanced training related to
such program of education provided by such
school, but only if such program, or such unit,
college or university is accredited.
(4) Associate degree school of nursing
The term ‘‘associate degree school of nursing’’ means a department, division, or other
administrative unit in a junior college, community college, college, or university which
provides primarily or exclusively a two-year
program of education in professional nursing
and allied subjects leading to an associate degree in nursing or to an equivalent degree, but
only if such program, or such unit, college, or
university is accredited.
(5) Diploma school of nursing
The term ‘‘diploma school of nursing’’
means a school affiliated with a hospital or
university, or an independent school, which
provides primarily or exclusively a program of
education in professional nursing and allied
subjects leading to a diploma or to equivalent
indicia that such program has been satisfactorily completed, but only if such program, or
such affiliated school or such hospital or university or such independent school is accredited.
(6) Accredited
(A) In general
Except as provided in subparagraph (B),
the term ‘‘accredited’’ when applied to any
program of nurse education means a program accredited by a recognized body or
bodies, or by a State agency, approved for
such purpose by the Secretary of Education
and when applied to a hospital, school, col-

Page 837

TITLE 42—THE PUBLIC HEALTH AND WELFARE

lege, or university (or a unit thereof) means
a hospital, school, college, or university (or
a unit thereof) which is accredited by a recognized body or bodies, or by a State agency,
approved for such purpose by the Secretary
of Education. For the purpose of this paragraph, the Secretary of Education shall publish a list of recognized accrediting bodies,
and of State agencies, which the Secretary
of Education determines to be reliable authority as to the quality of education offered.
(B) New programs
A new program of nursing that, by reason
of an insufficient period of operation, is not,
at the time of the submission of an application for a grant or contract under this subchapter, eligible for accreditation by such a
recognized body or bodies or State agency,
shall be deemed accredited for purposes of
this subchapter if the Secretary of Education finds, after consultation with the appropriate accreditation body or bodies, that
there is reasonable assurance that the program will meet the accreditation standards
of such body or bodies prior to the beginning
of the academic year following the normal
graduation date of students of the first entering class in such a program.
(7) Nonprofit
The term ‘‘nonprofit’’ as applied to any
school, agency, organization, or institution
means one which is a corporation or association, or is owned and operated by one or more
corporations or associations, no part of the
net earnings of which inures, or may lawfully
inure, to the benefit of any private shareholder or individual.

§ 296

(12) Home health agency
The term ‘‘home health agency’’ has the
meaning given such term in section 1861(o) of
the Social Security Act [42 U.S.C. 1395x(o)].
(13) Hospice program
The term ‘‘hospice program’’ has the meaning given such term in section 1861(dd)(2) of
the Social Security Act [42 U.S.C. 1395x(dd)(2)].
(14) Rural health clinic
The term ‘‘rural health clinic’’ has the
meaning given such term in section 1861(aa)(2)
of the Social Security Act [42 U.S.C.
1395x(aa)(2)].
(15) Skilled nursing facility
The term ‘‘skilled nursing facility’’ has the
meaning given such term in section 1819(a) of
the Social Security Act [42 U.S.C. 1395i–3(a)].
(16) Accelerated nursing degree program
The term ‘‘accelerated nursing degree program’’ means a program of education in professional nursing offered by an accredited
school of nursing in which an individual holding a bachelors degree in another discipline receives a BSN or MSN degree in an accelerated
time frame as determined by the accredited
school of nursing.
(17) Bridge or degree completion program
The term ‘‘bridge or degree completion program’’ means a program of education in professional nursing offered by an accredited
school of nursing, as defined in paragraph (2),
that leads to a baccalaureate degree in nursing. Such programs may include, Registered
Nurse (RN) to Bachelor’s of Science of Nursing
(BSN) programs, RN to MSN (Master of
Science of Nursing) programs, or BSN to Doctoral programs.

(8) State
The term ‘‘State’’ means a State, the Commonwealth of Puerto Rico, the District of Columbia, the Commonwealth of the Northern
Mariana Islands, Guam, American Samoa, the
Virgin Islands, or the Trust Territory of the
Pacific Islands.

(July 1, 1944, ch. 373, title VIII, § 801, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3562; amended Pub. L. 107–205, title I, § 101,
Aug. 1, 2002, 116 Stat. 811; Pub. L. 111–148, title V,
§ 5002(c), Mar. 23, 2010, 124 Stat. 591.)

(9) Ambulatory surgical center
The term ‘‘ambulatory surgical center’’ has
the meaning applicable to such term under
title XVIII of the Social Security Act [42
U.S.C. 1395 et seq.].

The Social Security Act, referred to in par. (9), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title
XVIII of the Act is classified generally to subchapter
XVIII (§ 1395 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.

(10) Federally qualified health center
The term ‘‘Federally qualified health center’’ has the meaning given such term under
section 1861(aa)(4) of the Social Security Act
[42 U.S.C. 1395x(aa)(4)].
(11) Health care facility
The term ‘‘health care facility’’ means an
Indian Health Service health center, a Native
Hawaiian health center, a hospital, a Federally qualified health center, a rural health
clinic, a nursing home, a home health agency,
a hospice program, a public health clinic, a
State or local department of public health, a
skilled nursing facility, an ambulatory surgical center, or any other facility designated
by the Secretary.

REFERENCES IN TEXT

PRIOR PROVISIONS
A prior section 296, act July 1, 1944, ch. 373, title VIII,
§ 801 as added Sept. 4, 1964, Pub. L. 88–581, § 2, 78 Stat.
908; amended Nov. 3, 1966, Pub. L. 89–751, § 8(a), 80 Stat.
1236; Aug. 16, 1968, Pub. L. 90–490, title II, § 201(a), 82
Stat. 780; Nov. 18, 1971, Pub. L. 92–158, § 2(a), 85 Stat. 465;
July 29, 1975, Pub. L. 94–63, title IX, §§ 902(a), 910(a)(1),
89 Stat. 354, 355; Sept. 29, 1979, Pub. L. 96–76, title I,
§ 102, 93 Stat. 579, authorized appropriations for construction grants, prior to repeal by Pub. L. 99–92,
§§ 9(a)(1), 10(a), Aug. 16, 1985, 99 Stat. 400, 402, effective
Oct. 1, 1985.
AMENDMENTS
2010—Par. (2). Pub. L. 111–148, § 5002(c)(1), substituted
‘‘means an accredited (as defined in paragraph 6) collegiate, associate degree, or diploma school of nursing in
a State where graduates are—’’ for ‘‘means a collegiate,

§ 296a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

associate degree, or diploma school of nursing in a
State.’’ and added subpars. (A) and (B).
Pars. (16), (17). Pub. L. 111–148, § 5002(c)(2), added pars.
(16) and (17).
2002—Pars. (9) to (15). Pub. L. 107–205 added pars. (9)
to (15).
SAVINGS PROVISION
Pub. L. 105–392, title I, § 124, Nov. 13, 1998, 112 Stat.
3574, provided that: ‘‘In the case of any authority for
making awards of grants or contracts that is terminated by the amendment made by section 123 [enacting
sections 296, 296a to 296f, 296j, 296m, 296p, 297q, and 297t
of this title, transferring section 298b–2 of this title to
section 296g of this title, and repealing sections 296k to
296m, 296r, 297, 297–1, 297c, 298, 298a, 298b, 298b–1, 298b–3
to 298b–5, and 298b–7 of this title], the Secretary of
Health and Human Services may, notwithstanding the
termination of the authority, continue in effect any
grant or contract made under the authority that is in
effect on the day before the date of the enactment of
this Act [Nov. 13, 1998], subject to the duration of any
such grant or contract not exceeding the period determined by the Secretary in first approving such financial assistance, or in approving the most recent request
made (before the date of such enactment) for continuation of such assistance, as the case may be.’’
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
REPORTS BY GOVERNMENT ACCOUNTABILITY OFFICE
Pub. L. 107–205, title II, § 204, Aug. 1, 2002, 116 Stat.
818, provided that:
‘‘(a) NATIONAL VARIATIONS.—Not later than 4 years
after the date of the enactment of this Act [Aug. 1,
2002], the Comptroller General of the United States
shall conduct a survey to determine national variations
in the nursing shortage at hospitals, nursing homes,
and other health care providers, and submit a report,
including recommendations, to the Congress on Federal
remedies to ease nursing shortages. The Comptroller
General shall submit to the Congress this report describing the findings relating to ownership status and
associated remedies.
‘‘(b) HIRING DIFFERENCES AMONG CERTAIN PRIVATE ENTITIES.—The Comptroller General of the United States
shall conduct a study to determine differences in the
hiring of nurses by nonprofit private entities as compared to the hiring of nurses by private entities that
are not nonprofit. In carrying out the study, the Comptroller General shall determine the effect of the inclusion of private entities that are not nonprofit in the
program under section 846 of the Public Health Service
Act [section 297n of this title]. Not later than 4 years
after the date of the enactment of this Act [Aug. 1,
2002], the Comptroller General shall submit to the Congress a report describing the findings of the study.
‘‘(c) NURSING SCHOLARSHIPS.—The Comptroller General of the United States shall conduct an evaluation of
whether the program carried out under section 846(d) of
the Public Health Service Act [section 297n(d) of this
title] has demonstrably increased the number of applicants to schools of nursing and, not later than 4 years
after the date of the enactment of this Act [Aug. 1,
2002], submit a report to the Congress on the results of
such evaluation.’’
PURPOSE
Pub. L. 105–392, title I, § 122, Nov. 13, 1998, 112 Stat.
3562, provided that: ‘‘It is the purpose of this subtitle
[subtitle B (§§ 121–124) of title I of Pub. L. 105–392, see
Short Title of 1998 Amendment note set out under section 201 of this title] to restructure the nurse education
authorities of title VIII of the Public Health Service
Act [this subchapter] to permit a comprehensive, flexi-

Page 838

ble, and effective approach to Federal support for nursing workforce development.’’
INFORMATION RESPECTING SUPPLY AND DISTRIBUTION
OF AND REQUIREMENTS FOR NURSES; DETERMINATION
PROCEDURES; SURVEYS AND COLLECTION OF DATES;
ANNUAL REPORT TO CONGRESS ON DETERMINATIONS,
ETC.; REVIEW BY OFFICE OF MANAGEMENT AND BUDGET OF REPORT PRIOR TO SUBMISSION
Section 951 of Pub. L. 94–63, as amended by Pub. L.
95–623, § 12(h), Nov. 9, 1978, 92 Stat. 3457, provided that:
‘‘(a)(1) Using procedures developed in accordance with
paragraph (3), the Secretary of Health, Education, and
Welfare [now Health and Human Services] (hereinafter
in this section referred to as the ‘Secretary’) shall determine on a continuing basis—
‘‘(A) the supply (both current and projected and
within the United States and within each State) of
registered nurses, licensed practical and vocational
nurses, nurse’s aides, registered nurses with advanced
training or graduate degrees, and nurse practitioners;
‘‘(B) the distribution within the United States and
within each State, of such nurses so as to determine
(i) those areas of the United States which are oversupplied or undersupplied, or which have an adequate
supply of such nurses in relation to the population of
the area, and (ii) the demand for the services which
such nurses provide; and
‘‘(C) the current and future requirements for such
nurses, nationally and within each State.
‘‘(2) The Secretary shall survey and gather data, on a
continuing basis, on—
‘‘(A) the number and distribution of nurses, by type
of employment and location of practice;
‘‘(B) the number of nurses who are practicing full
time and those who are employed part time, within
the United States and within each State;
‘‘(C) the average rates of compensation for nurses,
by type of practice and location of practice;
‘‘(D) the activity status of the total number of registered nurses within the United States and within
each State;
‘‘(E) the number of nurses with advanced training
or graduate degrees in nursing, by specialty, including nurse practitioners, nurse clinicians, nurse researchers, nurse educators, and nurse supervisors and
administrators; and
‘‘(F) the number of registered nurses entering the
United States annually from other nations, by country of nurse training and by immigrant status.
‘‘(3) Within six months of the date of the enactment
of this Act [July 29, 1975], the Secretary shall develop
procedures for determining (on both a current and projected basis) the supply and distribution of and requirements for nurses within the United States and within
each State.
‘‘(b) Not later than October 1, 1979, and October 1 of
each odd-numbered year thereafter, the Secretary shall
report to the Congress—
‘‘(1) his determinations under subsection (a)(1) and
the data gathered under subsection (a)(2);
‘‘(2) an analysis of such determination and data;
and
‘‘(3) recommendations for such legislation as the
Secretary determines, based on such determinations
and data, will achieve (A) an equitable distribution of
nurses within the United States and within each
State, and (B) adequate supplies of nurses within the
United States and within each State.
‘‘(c) The Office of Management and Budget may review the Secretary’s report under subsection (b) before
its submission to the Congress, but the Office may not
revise the report or delay its submission, and it may
submit to the Congress its comments (and those of
other departments or agencies of the Government) respecting such report.’’

§ 296a. Application
(a) In general
To be eligible to receive a grant or contract
under this subchapter, an eligible entity shall

Page 839

TITLE 42—THE PUBLIC HEALTH AND WELFARE

prepare and submit to the Secretary an application that meets the requirements of this section, at such time, in such manner, and containing such information as the Secretary may require.
(b) Plan
An application submitted under this section
shall contain the plan of the applicant for carrying out a project with amounts received under
this subchapter. Such plan shall be consistent
with relevant Federal, State, or regional program plans.
(c) Performance outcome standards
An application submitted under this section
shall contain a specification by the applicant
entity of performance outcome standards that
the project to be funded under the grant or contract will be measured against. Such standards
shall address relevant national nursing needs
that the project will meet. The recipient of a
grant or contract under this section shall meet
the standards set forth in the grant or contract
application.
(d) Linkages
An application submitted under this section
shall contain a description of the linkages with
relevant educational and health care entities,
including training programs for other health
professionals as appropriate, that the project to
be funded under the grant or contract will establish.
(July 1, 1944, ch. 373, title VIII, § 802, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3564.)
PRIOR PROVISIONS
A prior section 296a, act July 1, 1944, ch. 373, title
VIII, § 802, as added Sept. 4, 1964, Pub. L. 88–581, § 2, 78
Stat. 909; amended Aug. 16, 1968, Pub. L. 90–490, title II,
§ 201(b), 82 Stat. 780; Nov. 18, 1971, Pub. L. 92–158,
§§ 2(d)(3), (e), (f), 13, 85 Stat. 468, 480; July 29, 1975, Pub.
L. 94–63, title IX, §§ 910(a)(2), 941(a), 89 Stat. 355, 363, related to time of submission, determinations, etc., respecting applications for construction grants, prior to
repeal by Pub. L. 99–92, §§ 9(a)(1), 10(a), Aug. 16, 1985, 99
Stat. 400, 402, effective Oct. 1, 1985.

§ 296b. Use of funds
(a) In general
Amounts provided under a grant or contract
awarded under this subchapter may be used for
training program development and support, faculty development, model demonstrations, trainee support including tuition, books, program
fees and reasonable living expenses during the
period of training, technical assistance, workforce analysis, and dissemination of information, as appropriate to meet recognized nursing
objectives, in accordance with this subchapter.
(b) Maintenance of effort
With respect to activities for which a grant
awarded under this subchapter is to be expended, the entity shall agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level
of such expenditures maintained by the entity
for the fiscal year preceding the fiscal year for
which the entity receives such a grant.

§ 296d

(July 1, 1944, ch. 373, title VIII, § 803, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3564.)
PRIOR PROVISIONS
A prior section 296b, act July 1, 1944, ch. 373, title
VIII, § 803, as added Sept. 4, 1964, Pub. L. 88–581, § 2, 78
Stat. 911; amended Aug. 16, 1968, Pub. L. 90–490, title II,
§ 202, 82 Stat. 780; Nov. 18, 1971, Pub. L. 92–158, §§ 2(b), 13,
85 Stat. 465, 480; July 29, 1975, Pub. L. 94–63, title IX,
§ 941(b), 89 Stat. 364, set forth provisions relating to
amount of construction grant, prior to repeal by Pub.
L. 99–92, §§ 9(a)(1), 10(a), Aug. 16, 1985, 99 Stat. 400, 402,
effective Oct. 1, 1985.

§ 296c. Matching requirement
The Secretary may require that an entity that
applies for a grant or contract under this subchapter provide non-Federal matching funds, as
appropriate, to ensure the institutional commitment of the entity to the projects funded under
the grant. Such non-Federal matching funds
may be provided directly or through donations
from public or private entities and may be in
cash or in-kind, fairly evaluated, including
plant, equipment, or services.
(July 1, 1944, ch. 373, title VIII, § 804, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3565.)
PRIOR PROVISIONS
A prior section 296c, act July 1, 1944, ch. 373, title
VIII, § 804, as added Sept. 4, 1964, Pub. L. 88–581, § 2, 78
Stat. 911; amended Nov. 18, 1971, Pub. L. 92–158,
§§ 2(d)(3), 13, 85 Stat. 468, 480; July 29, 1975, Pub. L. 94–63,
title IX, § 941(c), 89 Stat. 364, which related to recovery
of payments of funds by United States for construction
of facilities, was renumbered section 858 of act July 1,
1944, by Pub. L. 99–92 and transferred to section 298b–5
of this title.

§ 296d. Preference
In awarding grants or contracts under this
subchapter, the Secretary shall give preference
to applicants with projects that will substantially benefit rural or underserved populations,
or help meet public health nursing needs in
State or local health departments.
(July 1, 1944, ch. 373, title VIII, § 805, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3565.)
PRIOR PROVISIONS
A prior section 296d, act July 1, 1944, ch. 373, title
VIII, § 805, formerly § 809, as added Nov. 18, 1971, Pub. L.
92–158, § 2(c), 85 Stat. 465; renumbered § 805 and amended
July 29, 1975, Pub. L. 94–63, title IX, §§ 902(d),
910(b)(1)(A), (B)(i), (2), (c), 911(b), 941(d), 89 Stat. 355, 356,
364; Sept. 29, 1979, Pub. L. 96–76, title I, § 103, 93 Stat.
579, related to applications, amounts, etc., for loan
guarantees and interest subsidies for construction of
training facilities by nonprofit nursing schools, prior to
repeal by Pub. L. 99–92, §§ 9(a)(1), 10(a), Aug. 16, 1985, 99
Stat. 400, 402, effective Oct. 1, 1985.
Another prior section 296d, act July 1, 1944, ch. 373,
title VIII, § 805, as added Sept. 4, 1964, Pub. L. 88–581, § 2,
78 Stat. 912; amended Aug. 16, 1968, Pub. L. 90–490, title
II, §§ 211, 215, 82 Stat. 780, 783; Nov. 18, 1971, Pub. L.
92–158, § 3(b), 85 Stat. 469, relating to special project
grants and contracts for nurse training programs, was
repealed by Pub. L. 94–63, title IX, § 922, July 29, 1975, 89
Stat. 359, eff. July 1, 1975.

§ 296e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 296e. Generally applicable provisions
(a) Awarding of grants and contracts
The Secretary shall ensure that grants and
contracts under this subchapter are awarded on
a competitive basis, as appropriate, to carry out
innovative demonstration projects or provide for
strategic workforce supplementation activities
as needed to meet national nursing service goals
and in accordance with this subchapter. Contracts may be entered into under this subchapter with public or private entities as determined necessary by the Secretary.
(b) Information requirements
(1) In general
Recipients of grants and contracts under
this subchapter shall meet information requirements as specified by the Secretary.
(2) Evaluations
The Secretary shall establish procedures to
ensure the annual evaluation of programs and
projects operated by recipients of grants under
this subchapter. Such procedures shall ensure
that continued funding for such programs and
projects will be conditioned upon a demonstration that satisfactory progress has been made
by the program or project in meeting the objectives of the program or project.
(c) Training programs
Training programs conducted with amounts
received under this subchapter shall meet applicable accreditation and quality standards.
(d) Duration of assistance
(1) In general
Subject to paragraph (2), in the case of an
award to an entity of a grant, cooperative
agreement, or contract under this subchapter,
the period during which payments are made to
the entity under the award may not exceed 5
years. The provision of payments under the
award shall be subject to annual approval by
the Secretary of the payments and subject to
the availability of appropriations for the fiscal
year involved to make the payments. This
paragraph may not be construed as limiting
the number of awards under the program involved that may be made to the entity.
(2) Limitation
In the case of an award to an entity of a
grant, cooperative agreement, or contract
under this subchapter, paragraph (1) shall
apply only to the extent not inconsistent with
any other provision of this subchapter that relates to the period during which payments
may be made under the award.
(e) Peer review regarding certain programs
(1) In general
Each application for a grant under this subchapter, except advanced nurse traineeship
grants under section 296j(a)(2) of this title,
shall be submitted to a peer review group for
an evaluation of the merits of the proposals
made in the application. The Secretary may
not approve such an application unless a peer
review group has recommended the application for approval.

Page 840

(2) Composition
Each peer review group under this subsection shall be composed principally of individuals who are not officers or employees of
the Federal Government. In providing for the
establishment of peer review groups and procedures, the Secretary shall, except as otherwise
provided, ensure sex, racial, ethnic, and geographic representation among the membership
of such groups.
(3) Administration
This subsection shall be carried out by the
Secretary acting through the Administrator of
the Health Resources and Services Administration.
(f) Analytic activities
The Secretary shall ensure that—
(1) cross-cutting workforce analytical activities are carried out as part of the workforce
information and analysis activities under this
subchapter; and
(2) discipline-specific workforce information
is developed and analytical activities are carried out as part of—
(A) the advanced education nursing activities under part B of this subchapter;
(B) the workforce diversity activities
under part C of this subchapter; and
(C) basic nursing education and practice
activities under part D of this subchapter.
(g) State and regional priorities
Activities under grants or contracts under this
subchapter shall, to the extent practicable, be
consistent with related Federal, State, or regional nursing professions program plans and
priorities.
(h) Filing of applications
(1) In general
Applications for grants or contracts under
this subchapter may be submitted by health
professions schools, schools of nursing, academic health centers, State or local governments, or other appropriate public or private
nonprofit entities as determined appropriate
by the Secretary in accordance with this subchapter.
(2) For-profit entities
Notwithstanding paragraph (1), a for-profit
entity may be eligible for a grant or contract
under this subchapter as determined appropriate by the Secretary.
(July 1, 1944, ch. 373, title VIII, § 806, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3565.)
PRIOR PROVISIONS
A prior section 296e, act July 1, 1944, ch. 373, title
VIII, § 810, formerly § 806, as added Sept. 4, 1964, Pub. L.
88–581, § 2, 78 Stat. 912; amended Dec. 5, 1967, Pub. L.
90–174, § 12(a), 81 Stat. 541; Aug. 16, 1968, Pub. L. 90–490,
title II, § 211, 82 Stat. 781; Nov. 18, 1971, Pub. L. 92–158,
§ 4(a), 85 Stat. 470; renumbered § 810 and amended July
29, 1975, Pub. L. 94–63, title IX, §§ 902(b), 915(a)–(c), 916(a),
(b), 941(e), 89 Stat. 354, 356, 358, 365; Aug. 1, 1977, Pub. L.
95–83, title III, § 307(o)(1)–(4), 91 Stat. 393; Sept. 29, 1979,
Pub. L. 96–76, title I, § 104, 93 Stat. 579, set forth provisions relating to computation, requirements, etc., respecting grants for institutional support, prior to re-

Page 841

TITLE 42—THE PUBLIC HEALTH AND WELFARE

peal by Pub. L. 99–92, §§ 9(a)(1), 10(a), Aug. 16, 1985, 99
Stat. 400, 402, effective Oct. 1, 1985.

§ 296e–1. Grants for health professions education
(a) Cultural competency, prevention, and public
health and individuals with disability grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make awards of grants, contracts, or cooperative agreements to eligible entities for the development, evaluation, and dissemination of research, demonstration projects,
and model curricula for cultural competency,
prevention, public health proficiency, reducing
health disparities, and aptitude for working
with individuals with disabilities training for
use in health professions schools and continuing
education programs, and for other purposes determined as appropriate by the Secretary.
Grants under this section shall be the same as
provided in section 293e of this title.
(b) Collaboration
In carrying out subsection (a), the Secretary
shall collaborate with the entities described in
section 293e(b) of this title. The Secretary shall
coordinate with curricula and research and demonstration projects developed under such section
293e.
(c) Dissemination
Model curricula developed under this section
shall be disseminated and evaluated in the same
manner as model curricula developed under section 293e of this title, as described in subsection
(c) of such section.
(d) Authorization of appropriations
There are to be appropriated to carry out this
section such sums as may be necessary for each
of the fiscal years 2010 through 2015.
(July 1, 1944, ch. 373, title VIII, § 807, as added
Pub. L. 106–525, title IV, § 401(b)(2), Nov. 22, 2000,
114 Stat. 2508; amended Pub. L. 111–148, title V,
§ 5307(b), Mar. 23, 2010, 124 Stat. 628.)
PRIOR PROVISIONS
A prior section 807 of act July 1, 1944, was renumbered
section 808 by Pub. L. 106–525 and is classified to section
296f of this title.
Another prior section 807 of act July 1, 1944, was renumbered section 811 and classified to section 296f of
this title prior to repeal by Pub. L. 99–92, § 9(a)(1), Aug.
16, 1985, 99 Stat. 400.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5307(b)(1), in heading, substituted ‘‘Cultural competency, prevention, and
public health and individuals with disability grants’’
for ‘‘Grants for health professions education in health
disparities and cultural competency’’ and, in text, substituted ‘‘for the development, evaluation, and dissemination of research, demonstration projects, and model
curricula for cultural competency, prevention, public
health proficiency, reducing health disparities, and aptitude for working with individuals with disabilities
training for use in health professions schools and continuing education programs, and for other purposes determined as appropriate by the Secretary’’ for ‘‘for the
purpose of carrying out research and demonstration
projects (including research and demonstration
projects for continuing health professions education)
for training and education for the reduction of disparities in health care outcomes and the provision of culturally competent health care’’.

§ 296g

Subsecs. (b) to (d). Pub. L. 111–148, § 5307(b)(2)–(4),
added subsecs. (b) and (c), redesignated former subsec.
(b) as (d), and, in subsec. (d), substituted ‘‘this section’’
for ‘‘subsection (a) of this section’’ and ‘‘2010 through
2015’’ for ‘‘2001 through 2004’’.

§ 296f. Technical assistance
Funds appropriated under this subchapter may
be used by the Secretary to provide technical assistance in relation to any of the authorities
under this subchapter.
(July 1, 1944, ch. 373, title VIII, § 808, formerly
§ 807, as added Pub. L. 105–392, title I, § 123(4),
Nov. 13, 1998, 112 Stat. 3566; renumbered § 808,
Pub. L. 106–525, title IV, § 401(b)(1), Nov. 22, 2000,
114 Stat. 2508.)
PRIOR PROVISIONS
A prior section 296f, act July 1, 1944, ch. 373, title
VIII, § 811, formerly § 807, as added Aug. 16, 1968, Pub. L.
90–490, title II, § 212, 82 Stat. 782; amended Nov. 18, 1971,
Pub. L. 92–158, § 4(c), 85 Stat. 475; renumbered § 811 and
amended July 29, 1975, Pub. L. 94–63, title IX, § 941(f), 89
Stat. 365, related to filing dates, etc., for applications
for grants, prior to repeal by Pub. L. 99–92, §§ 9(a)(1),
10(a), Aug. 16, 1985, 99 Stat. 400, 402, effective Oct. 1,
1985.
A prior section 808 of act July 1, 1944, was classified
to section 296g of this title prior to repeal by Pub. L.
94–63, title IX, § 922, July 29, 1975, 89 Stat. 359.

§ 296g. Prohibition against discrimination by
schools on basis of sex
The Secretary may not make a grant, loan
guarantee, or interest subsidy payment under
this subchapter to, or for the benefit of, any
school of nursing unless the application for the
grant, loan guarantee, or interest subsidy payment contains assurances satisfactory to the
Secretary that the school will not discriminate
on the basis of sex in the admission of individuals to its training programs. The Secretary
may not enter into a contract under this subchapter with any school unless the school furnishes assurances satisfactory to the Secretary
that it will not discriminate on the basis of sex
in the admission of individuals to its training
programs.
(July 1, 1944, ch. 373, title VIII, § 809, formerly
§ 845, as added Pub. L. 92–158, § 11, Nov. 18, 1971,
85 Stat. 479; renumbered § 855, Pub. L. 94–63, title
IX, § 941(k)(1), July 29, 1975, 89 Stat. 366; renumbered § 810, Pub. L. 105–392, title I, § 123(6), Nov.
13, 1998, 112 Stat. 3574; renumbered § 809, Pub. L.
111–148, title V, § 5310(b)(1), Mar. 23, 2010, 124
Stat. 631.)
CODIFICATION
Section was formerly classified to section 298b–2 of
this title prior to renumbering by Pub. L. 105–392.
PRIOR PROVISIONS
A prior section 296g, act July 1, 1944, ch. 373, title
VIII, § 808, as added Aug. 16, 1968, Pub. L. 90–490, title II
§ 212, 82 Stat. 783; amended Nov. 18, 1971, Pub. L. 92–158,
§ 3(a), 85 Stat. 469; July 29, 1975, Pub. L. 94–63, title IX,
§ 902(c), 89 Stat. 354, authorized appropriations for special project grants and contracts and financial distress
grants from the fiscal year ending June 30, 1972 through
the fiscal year ending June 30, 1975, prior to repeal by
Pub. L. 94–63, title IX, §§ 905, 922, July 29, 1975, 89 Stat.
355, 359, effective July 1, 1975.
A prior section 296h, act July 1, 1944, ch. 373, title
VIII, § 809, as added Nov. 18, 1971, Pub. L. 92–158, § 2(c),

§ 296j

TITLE 42—THE PUBLIC HEALTH AND WELFARE

85 Stat. 465, which related to loan guarantees and interest subsidies for construction of training facilities by
nonprofit nursing schools, was renumbered section 805
of act July 1, 1944, by Pub. L. 94–63 and transferred to
section 296d of this title.
A prior section 296i, act July 1, 1944, ch. 373, title
VIII, § 810, as added Nov. 18, 1971, Pub. L. 92–158, § 4(b),
85 Stat. 474; amended July 29, 1975, Pub. L. 94–63, title
IX, § 902(e), 89 Stat. 355, authorized grants for start-up
programs for new nurse training programs, and set out
prerequisites, etc., prior to repeal by Pub. L. 94–63, title
IX, §§ 905, 931(b), July 29, 1975, 89 Stat. 355, 362, effective
July 1, 1975.

PART

B—NURSE PRACTITIONERS, NURSE MIDWIVES, NURSE ANESTHETISTS, AND OTHER ADVANCED EDUCATION NURSES
PRIOR PROVISIONS

A prior part B related to assistance to nursing students and consisted of sections 297 to 297n, prior to the
general amendment of this subchapter by Pub. L.
105–392.

§ 296j. Advanced education nursing grants
(a) In general
The Secretary may award grants to and enter
into contracts with eligible entities to meet the
costs of—
(1) projects that support the enhancement of
advanced nursing education and practice; and
(2) traineeships for individuals in advanced
nursing education programs.
(b) Definition of advanced education nurses
For purposes of this section, the term ‘‘advanced education nurses’’ means individuals
trained in advanced degree programs including
individuals in combined R.N./Master’s degree
programs, post-nursing master’s certificate programs, or, in the case of nurse midwives, in certificate programs in existence on the date that
is one day prior to November 13, 1998, to serve as
nurse practitioners, clinical nurse specialists,
nurse midwives, nurse anesthetists, nurse educators, nurse administrators, or public health
nurses, or in other nurse specialties determined
by the Secretary to require advanced education.
(c) Authorized nurse practitioner
Nurse practitioner programs eligible for support under this section are educational programs for registered nurses (irrespective of the
type of school of nursing in which the nurses received their training) that—
(1) meet guidelines prescribed by the Secretary; and
(2) have as their objective the education of
nurses who will upon completion of their studies in such programs, be qualified to effectively provide primary health care, including
primary health care in homes and in ambulatory care facilities, long-term care facilities,
acute care, and other health care settings.
(d) Authorized nurse-midwifery programs
Midwifery programs that are eligible for support under this section are educational programs that—
(1) have as their objective the education of
midwives; and
(2) are accredited by the American College of
Nurse-Midwives Accreditation Commission for
Midwifery Education.

Page 842

(e) Authorized nurse anesthesia programs
Nurse anesthesia programs eligible for support
under this section are education programs
that—
(1) provide registered nurses with full-time
anesthetist education; and
(2) are accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs.
(f) Other authorized educational programs
The Secretary shall prescribe guidelines as appropriate for other advanced nurse education
programs eligible for support under this section.
(g) Traineeships
(1) In general
The Secretary may not award a grant to an
applicant under subsection (a) of this section
unless the applicant involved agrees that
traineeships provided with the grant will only
pay all or part of the costs of—
(A) the tuition, books, and fees of the program of advanced nurse education with respect to which the traineeship is provided;
and
(B) the reasonable living expenses of the
individual during the period for which the
traineeship is provided.
(2) Special consideration
In making awards of grants and contracts
under subsection (a)(2) of this section, the Secretary shall give special consideration to an
eligible entity that agrees to expend the award
to train advanced education nurses who will
practice in health professional shortage areas
designated under section 254e of this title.
(July 1, 1944, ch. 373, title VIII, § 811, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3566; amended Pub. L. 111–148, title V,
§ 5308, Mar. 23, 2010, 124 Stat. 629.)
PRIOR PROVISIONS
A prior section 296j, act July 1, 1944, ch. 373, title
VIII, § 815, as added July 29, 1975, Pub. L. 94–63, title IX,
§ 921, 89 Stat. 358; amended Aug. 13, 1981, Pub. L. 97–35,
title XXVII, § 2752, 95 Stat. 929, set forth provisions relating to authorization, terms and conditions, etc., respecting grants for operational costs or meeting accreditation requirements, prior to repeal by Pub. L.
99–92, §§ 9(a)(1), 10(a), Aug. 16, 1985, 99 Stat. 400, 402, effective Oct. 1, 1985.
Prior sections 296k and 296l were repealed by Pub. L.
105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562.
Section 296k, act July 1, 1944, ch. 373, title VIII, § 820,
as added Pub. L. 94–63, title IX, § 931(a), July 29, 1975, 89
Stat. 359; amended Pub. L. 96–76, title I, § 105, Sept. 29,
1979, 93 Stat. 579; Pub. L. 97–35, title XXVII, § 2753(a)(1),
(b), Aug. 13, 1981, 95 Stat. 929; Pub. L. 99–92, § 3, Aug. 16,
1985, 99 Stat. 393; Pub. L. 99–129, title II, § 227(a), Oct. 22,
1985, 99 Stat. 547; Pub. L. 100–607, title VII, §§ 701(a)(2),
(b)–(i), 721(b)(1), Nov. 4, 1988, 102 Stat. 3153–3156, 3165;
Pub. L. 102–408, title II, § 202(a), Oct. 13, 1992, 106 Stat.
2069; Pub. L. 102–531, title III, § 313(a)(9), Oct. 27, 1992, 106
Stat. 3507, authorized grants and contracts for special
projects.
Section 296l, act July 1, 1944, ch. 373, title VIII, § 821,
as added Pub. L. 94–63, title IX, § 931(a), July 29, 1975, 89
Stat. 361; amended Pub. L. 96–76, title I, § 106, Sept. 29,
1979, 93 Stat. 579; Pub. L. 97–35, title XXVII, § 2754, Aug.
13, 1981, 95 Stat. 930; Pub. L. 99–92, § 4, Aug. 16, 1985, 99
Stat. 394; Pub. L. 99–129, title II, § 227(b), Oct. 22, 1985, 99
Stat. 548; Pub. L. 100–607, title VII, § 702, Nov. 4, 1988, 102

Page 843

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 3157; Pub. L. 102–408, title II, § 203, Oct. 13, 1992, 106
Stat. 2072, authorized grants and contracts for advanced nurse education.
AMENDMENTS
2010—Subsec. (c). Pub. L. 111–148, § 5308(1), struck out
‘‘and nurse midwifery programs’’ after ‘‘practitioner’’
in heading and ‘‘and nurse midwifery’’ after ‘‘practitioner’’ in introductory provisions.
Subsecs. (d), (e). Pub. L. 111–148, § 5308(3), (4), added
subsec. (d) and redesignated former subsec. (d) as (e).
Former subsec. (e) redesignated (f).
Subsec. (f). Pub. L. 111–148, § 5308(3), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).
Subsec. (f)(2), (3). Pub. L. 111–148, § 5308(2), redesignated par. (3) as (2) and struck out former par. (2). Prior
to amendment, text of par. (2) read as follows: ‘‘The
Secretary may not obligate more than 10 percent of the
traineeships under subsection (a) of this section for individuals in doctorate degree programs.’’
Subsec. (g). Pub. L. 111–148, § 5308(3), redesignated subsec. (f) as (g).

§ 296j–1. Demonstration grants for family nurse
practitioner training programs
(a) Establishment of program
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’)
shall establish a training demonstration program for family nurse practitioners (referred to
in this section as the ‘‘program’’) to employ and
provide 1-year training for nurse practitioners
who have graduated from a nurse practitioner
program for careers as primary care providers in
Federally qualified health centers (referred to in
this section as ‘‘FQHCs’’) and nurse-managed
health clinics (referred to in this section as
‘‘NMHCs’’).
(b) Purpose
The purpose of the program is to enable each
grant recipient to—
(1) provide new nurse practitioners with
clinical training to enable them to serve as
primary care providers in FQHCs and NMHCs;
(2) train new nurse practitioners to work
under a model of primary care that is consistent with the principles set forth by the Institute of Medicine and the needs of vulnerable
populations; and
(3) create a model of FQHC and NMHC training for nurse practitioners that may be replicated nationwide.
(c) Grants
The Secretary shall award 3-year grants to eligible entities that meet the requirements established by the Secretary, for the purpose of operating the nurse practitioner primary care programs described in subsection (a) in such entities.
(d) Eligible entities
To be eligible to receive a grant under this
section, an entity shall—
(1)(A) be a FQHC as defined in section
1395x(aa) of this title; or
(B) be a nurse-managed health clinic, as defined in section 330A–1 of the Public Health
Service Act [42 U.S.C. 254c–1a] (as added by
section 5208 of this Act); 1 and
(2) submit to the Secretary an application at
such time, in such manner, and containing
1 See

References in Text note below.

§ 296j–1

such information as the Secretary may require.
(e) Priority in awarding grants
In awarding grants under this section, the Secretary shall give priority to eligible entities
that—
(1) demonstrate sufficient infrastructure in
size, scope, and capacity to undertake the requisite training of a minimum of 3 nurse practitioners per year, and to provide to each awardee 12 full months of full-time, paid employment and benefits consistent with the benefits
offered to other full-time employees of such
entity;
(2) will assign not less than 1 staff nurse
practitioner or physician to each of 4
precepted clinics;
(3) will provide to each awardee specialty rotations, including specialty training in prenatal care and women’s health, adult and child
psychiatry, orthopedics, geriatrics, and at
least 3 other high-volume, high-burden specialty areas;
(4) provide sessions on high-volume, highrisk health problems and have a record of
training health care professionals in the care
of children, older adults, and underserved populations; and
(5) collaborate with other safety net providers, schools, colleges, and universities that
provide health professions training.
(f) Eligibility of nurse practitioners
(1) In general
To be eligible for acceptance to a program
funded through a grant awarded under this
section, an individual shall—
(A) be licensed or eligible for licensure in
the State in which the program is located as
an advanced practice registered nurse or advanced practice nurse and be eligible or
board-certified as a family nurse practitioner; and
(B) demonstrate commitment to a career
as a primary care provider in a FQHC or in
a NMHC.
(2) Preference
In selecting awardees under the program,
each grant recipient shall give preference to
bilingual candidates that meet the requirements described in paragraph (1).
(3) Deferral of certain service
The starting date of required service of individuals in the National Health Service Corps
Service program under title II of the Public
Health Service Act (42 U.S.C. 202 et seq.) who
receive training under this section shall be deferred until the date that is 22 days after the
date of completion of the program.
(g) Grant amount
Each grant awarded under this section shall be
in an amount not to exceed $600,000 per year. A
grant recipient may carry over funds from 1 fiscal year to another without obtaining approval
from the Secretary.
(h) Technical assistance grants
The Secretary may award technical assistance
grants to 1 or more FQHCs or NMHCs that have

§ 296m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

demonstrated expertise in establishing a nurse
practitioner residency training program. Such
technical assistance grants shall be for the purpose of providing technical assistance to other
recipients of grants under subsection (c).
(i) Authorization of appropriations
To carry out this section, there is authorized
to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2014.
(Pub. L. 111–148, title V, § 5316, as added Pub. L.
111–148, title X, § 10501(e), Mar. 23, 2010, 124 Stat.
995.)
REFERENCES IN TEXT
This Act, referred to in subsec. (d)(1)(B), is Pub. L.
111–148, Mar. 23, 2010, 124 Stat. 119, known as the Patient Protection and Affordable Care Act. For complete
classification of this Act to the Code, see Short Title
note set out under section 18001 of this title and Tables.
The Public Health Service Act, referred to in subsec.
(f)(3), is act July 1, 1944, ch. 373, 58 Stat. 682. Title II of
the Act is classified generally to subchapter I (§ 201 et
seq.) of this chapter. For complete classification of this
Act to the Code, see Short Title note set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

PART C—INCREASING NURSING WORKFORCE
DIVERSITY
PRIOR PROVISIONS
A prior part C set forth general provisions and consisted of sections 298 to 298b–7, prior to the general
amendment of this subchapter by Pub. L. 105–392.

§ 296m. Workforce diversity grants
(a) In general
(1) 1 Authority
The Secretary may award grants to and
enter into contracts with eligible entities to
meet the costs of special projects to increase
nursing education opportunities for individuals who are from disadvantaged backgrounds
(including racial and ethnic minorities underrepresented among registered nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses
to enter a bridge or degree completion program, student scholarships or stipends for accelerated nursing degree programs, pre-entry
preparation, advanced education preparation,
and retention activities.
(b) Guidance
In carrying out subsection (a) of this section,
the Secretary shall take into consideration the
recommendations of the National Advisory
Council on Nurse Education and Practice and
consult with nursing associations including the
National Coalition of Ethnic Minority Nurse Associations, American 2 Nurses Association, the
National League for Nursing, the American Association of Colleges of Nursing, the National
Black Nurses Association, the National Associa1 So
2 So

in original. No par. (2) has been enacted.
in original. Probably should be preceded by ‘‘the’’.

Page 844

tion of Hispanic Nurses, the Association of
Asian American and Pacific Islander Nurses, the
Native American Indian and Alaskan Nurses Association, and the National Council of State
Boards of Nursing, and other organizations determined appropriate by the Secretary.
(c) Required information and conditions for
award recipients
(1) In general
Recipients of awards under this section may
be required, where requested, to report to the
Secretary concerning the annual admission,
retention, and graduation rates for individuals
from disadvantaged backgrounds and ethnic
and racial minorities in the school or schools
involved in the projects.
(2) Falling rates
If any of the rates reported under paragraph
(1) fall below the average of the two previous
years, the grant or contract recipient shall
provide the Secretary with plans for immediately improving such rates.
(3) Ineligibility
A recipient described in paragraph (2) shall
be ineligible for continued funding under this
section if the plan of the recipient fails to improve the rates within the 1-year period beginning on the date such plan is implemented.
(July 1, 1944, ch. 373, title VIII, § 821, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3568; amended Pub. L. 111–148, title V,
§ 5404, Mar. 23, 2010, 124 Stat. 649.)
PRIOR PROVISIONS
A prior section 296m, act July 1, 1944, ch. 373, title
VIII, § 822, as added Pub. L. 94–63, title IX, § 931(a), July
29, 1975, 89 Stat. 361; amended Pub. L. 95–83, title III,
§ 307(o)(5)(A), Aug. 1, 1977, 91 Stat. 393; Pub. L. 96–76,
title I, § 107, Sept. 29, 1979, 93 Stat. 579; Pub. L. 97–35,
title XXVII, § 2755, Aug. 13, 1981, 95 Stat. 930; Pub. L.
99–92, § 5, Aug. 16, 1985, 99 Stat. 394; Pub. L. 99–129, title
II, § 227(c), Oct. 22, 1985, 99 Stat. 548; Pub. L. 100–607,
title VII, § 703, Nov. 4, 1988, 102 Stat. 3157; Pub. L. 101–93,
§ 5(q), Aug. 16, 1989, 103 Stat. 614; Pub. L. 101–597, title
IV, § 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3035; Pub. L.
102–408, title II, § 204, Oct. 13, 1992, 106 Stat. 2072, authorized grants and contracts for nurse practitioner and
nurse midwife programs, prior to repeal by Pub. L.
105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562.
A prior section 821 of act July 1, 1944, was classified
to section 296l of this title prior to repeal by Pub. L.
105–392.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5404(1), designated
existing provisions as par. (1), inserted heading, and
substituted ‘‘stipends for diploma or associate degree
nurses to enter a bridge or degree completion program,
student scholarships or stipends for accelerated nursing
degree programs, pre-entry preparation, advanced education preparation, and retention activities’’ for ‘‘preentry preparation, and retention activities’’.
Subsec. (b). Pub. L. 111–148, § 5404(2), substituted ‘‘National Advisory Council on Nurse Education and Practice and consult with nursing associations including
the National Coalition of Ethnic Minority Nurse Associations,’’ for ‘‘First, Second and Third Invitational
Congresses for Minority Nurse Leaders on ‘Caring for
the Emerging Majority,’ in 1992, 1993 and 1997, and consult with nursing associations including the’’ and inserted ‘‘, and other organizations determined appropriate by the Secretary’’ before period at end.

Page 845

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART D—STRENGTHENING CAPACITY FOR BASIC
NURSE EDUCATION AND PRACTICE
PRIOR PROVISIONS
A prior part D related to scholarship grants to
schools of nursing and consisted of sections 298c to
298c–8, prior to the general amendment of this subchapter by Pub. L. 105–392.

§ 296p. Nurse education, practice, and quality
grants
(a) Education priority areas
The Secretary may award grants to or enter
into contracts with eligible entities for—
(1) expanding the enrollment in baccalaureate nursing programs; or
(2) providing education in new technologies,
including distance learning methodologies.
(b) Practice priority areas
The Secretary may award grants to or enter
into contracts with eligible entities for—
(1) establishing or expanding nursing practice arrangements in noninstitutional settings
to demonstrate methods to improve access to
primary health care in medically underserved
communities;
(2) providing care for underserved populations and other high-risk groups such as the
elderly, individuals with HIV/AIDS, substance
abusers, the homeless, and victims of domestic
violence;
(3) providing coordinated care, and other
skills needed to practice in existing and
emerging organized health care systems; or
(4) developing cultural competencies among
nurses.
(c) Retention priority areas
The Secretary may award grants to and enter
into contracts with eligible entities to enhance
the nursing workforce by initiating and maintaining nurse retention programs pursuant to
paragraph (1) or (2).
(1) Grants for career ladder programs
The Secretary may award grants to and
enter into contracts with eligible entities for
programs—
(A) to promote career advancement for
nursing personnel in a variety of training
settings, cross training or specialty training
among diverse population groups, and the
advancement of individuals including to become professional nurses, advanced education nurses, licensed practical nurses, certified nurse assistants, and home health
aides; and
(B) to assist individuals in obtaining education and training required to enter the
nursing profession and advance within such
profession, such as by providing career counseling and mentoring.
(2) Enhancing patient care delivery systems
(A) Grants
The Secretary may award grants to eligible entities to improve the retention of
nurses and enhance patient care that is directly related to nursing activities by enhancing collaboration and communication
among nurses and other health care profes-

§ 296p

sionals, and by promoting nurse involvement in the organizational and clinical decisionmaking processes of a health care facility.
(B) Preference
In making awards of grants under this
paragraph, the Secretary shall give a preference to applicants that have not previously received an award under this paragraph.
(C) Continuation of an award
The Secretary shall make continuation of
any award under this paragraph beyond the
second year of such award contingent on the
recipient of such award having demonstrated
to the Secretary measurable and substantive
improvement in nurse retention or patient
care.
(d) Other priority areas
The Secretary may award grants to or enter
into contracts with eligible entities to address
other areas that are of high priority to nurse
education, practice, and retention, as determined by the Secretary.
(e) Preference
For purposes of any amount of funds appropriated to carry out this section for fiscal year
2003, 2004, or 2005 that is in excess of the amount
of funds appropriated to carry out this section
for fiscal year 2002, the Secretary shall give preference to awarding grants or entering into contracts under subsections (a)(2) and (c) of this
section.
(f) Report
The Secretary shall submit to the Congress
before the end of each fiscal year a report on the
grants awarded and the contracts entered into
under this section. Each such report shall identify the overall number of such grants and contracts and provide an explanation of why each
such grant or contract will meet the priority
need of the nursing workforce.
(g) Eligible entity
For purposes of this section, the term ‘‘eligible entity’’ includes a school of nursing, as defined in section 296(2) of this title,,1 a health
care facility, or a partnership of such a school
and facility.
(h) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title VIII, § 831, as added
Pub. L. 105–392, title I, § 123(4), Nov. 13, 1998, 112
Stat. 3568; amended Pub. L. 107–205, title II, § 201,
Aug. 1, 2002, 116 Stat. 815; Pub. L. 111–148, title V,
§ 5309(a), Mar. 23, 2010, 124 Stat. 629.)
PRIOR PROVISIONS
A prior section 831 of act July 1, 1944, was classified
to section 297–1 of this title prior to repeal by Pub. L.
105–392.
AMENDMENTS
2010—Pub. L. 111–148, § 5309(a)(1), substituted ‘‘quality’’ for ‘‘retention’’ in section catchline.
1 So

in original.

§ 296p–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a). Pub. L. 111–148, § 5309(a)(2), in par. (1), inserted ‘‘or’’ at end, redesignated par. (3) as (2), and
struck out former par. (2) which read as follows: ‘‘developing and implementing internship and residency programs to encourage mentoring and the development of
specialties; or’’.
Subsec. (b)(3). Pub. L. 111–148, § 5309(a)(3), substituted
‘‘coordinated care’’ for ‘‘managed care, quality improvement’’.
Subsec. (g). Pub. L. 111–148, § 5309(a)(4), inserted ‘‘, as
defined in section 296(2) of this title,’’ after ‘‘school of
nursing’’.
Subsec. (h). Pub. L. 111–148, § 5309(a)(5), substituted
‘‘2010 through 2014’’ for ‘‘2003 through 2007’’.
2002—Pub. L. 107–205 amended section catchline and
text generally. Prior to amendment, text read as follows:
‘‘(a) IN GENERAL.—The Secretary may award grants
to and enter into contracts with eligible entities for
projects to strengthen capacity for basic nurse education and practice.
‘‘(b) PRIORITY AREAS.—In awarding grants or contracts under this section the Secretary shall give priority to entities that will use amounts provided under
such a grant or contract to enhance the educational
mix and utilization of the basic nursing workforce by
strengthening programs that provide basic nurse education, such as through—
‘‘(1) establishing or expanding nursing practice arrangements in noninstitutional settings to demonstrate methods to improve access to primary
health care in medically underserved communities;
‘‘(2) providing care for underserved populations and
other high-risk groups such as the elderly, individuals with HIV-AIDS, substance abusers, the homeless, and victims of domestic violence;
‘‘(3) providing managed care, quality improvement,
and other skills needed to practice in existing and
emerging organized health care systems;
‘‘(4) developing cultural competencies among
nurses;
‘‘(5) expanding the enrollment in baccalaureate
nursing programs;
‘‘(6) promoting career mobility for nursing personnel in a variety of training settings and cross training or specialty training among diverse population
groups;
‘‘(7) providing education in informatics, including
distance learning methodologies; or
‘‘(8) other priority areas as determined by the Secretary.’’

§ 296p–1. Nurse retention grants
(a) Retention priority areas
The Secretary may award grants to, and enter
into contracts with, eligible entities to enhance
the nursing workforce by initiating and maintaining nurse retention programs pursuant to
subsection (b) or (c).
(b) Grants for career ladder program
The Secretary may award grants to, and enter
into contracts with, eligible entities for programs—
(1) to promote career advancement for individuals including licensed practical nurses, licensed vocational nurses, certified nurse assistants, home health aides,1 diploma degree
or associate degree nurses, to become baccalaureate prepared registered nurses or advanced education nurses in order to meet the
needs of the registered nurse workforce;
(2) developing and implementing internships
and residency programs in collaboration with
1 So

in original. The word ‘‘and’’ probably should appear.

Page 846

an accredited school of nursing, as defined by
section 296(2) of this title, to encourage mentoring and the development of specialties; or
(3) to assist individuals in obtaining education and training required to enter the nursing profession and advance within such profession.
(c) Enhancing patient care delivery systems
(1) Grants
The Secretary may award grants to eligible
entities to improve the retention of nurses and
enhance patient care that is directly related
to nursing activities by enhancing collaboration and communication among nurses and
other health care professionals, and by promoting nurse involvement in the organizational and clinical decision-making processes
of a health care facility.
(2) Priority
In making awards of grants under this subsection, the Secretary shall give preference to
applicants that have not previously received
an award under this subsection (or section
296p(c) of this title as such section existed on
the day before March 23, 2010).
(3) Continuation of an award
The Secretary shall make continuation of
any award under this subsection beyond the
second year of such award contingent on the
recipient of such award having demonstrated
to the Secretary measurable and substantive
improvement in nurse retention or patient
care.
(d) Other priority areas
The Secretary may award grants to, or enter
into contracts with, eligible entities to address
other areas that are of high priority to nurse retention, as determined by the Secretary.
(e) Report
The Secretary shall submit to the Congress
before the end of each fiscal year a report on the
grants awarded and the contracts entered into
under this section. Each such report shall identify the overall number of such grants and contracts and provide an explanation of why each
such grant or contract will meet the priority
need of the nursing workforce.
(f) Eligible entity
For purposes of this section, the term ‘‘eligible entity’’ includes an accredited school of
nursing, as defined by section 296(2) of this title,
a health care facility, or a partnership of such a
school and facility.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2012.
(July 1, 1944, ch. 373, title VIII, § 831A, as added
Pub. L. 111–148, title V, § 5309(b), Mar. 23, 2010, 124
Stat. 630.)
PRIOR PROVISIONS
Prior sections 296r, 297, and
Pub. L. 105–392, title I, § 123(1),
3562.
Section 296r, act July 1, 1944,
as added Pub. L. 100–607, title

297–1 were repealed by
Nov. 13, 1998, 112 Stat.
ch. 373, title VIII, § 827,
VII, § 701(a)(3), Nov. 4,

Page 847

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1988, 102 Stat. 3153; amended Pub. L. 102–408, title II,
§ 205, Oct. 13, 1992, 106 Stat. 2073, authorized grants and
contracts for special projects to increase nursing education opportunities for individuals from disadvantaged backgrounds.
Section 297, act July 1, 1944, ch. 373, title VIII, § 830,
formerly § 821, as added Pub. L. 88–581, § 2, Sept. 4, 1964,
78 Stat. 913; amended Pub. L. 90–490, title II, § 221, Aug.
16, 1968, 82 Stat. 783; Pub. L. 92–52, § 5, July 9, 1971, 85
Stat. 145; Pub. L. 92–158, §§ 5, 13, Nov. 18, 1971, 85 Stat.
475, 480; renumbered § 830 and amended Pub. L. 94–63,
title IX, §§ 935, 941(g)(2), July 29, 1975, 89 Stat. 362, 365;
Pub. L. 94–484, title IX, § 901, Oct. 12, 1976, 90 Stat. 2323;
Pub. L. 95–83, title III, § 307(o)(5)(B), Aug. 1, 1977, 91
Stat. 394; Pub. L. 96–76, title I, § 108, Sept. 29, 1979, 93
Stat. 579; Pub. L. 97–35, title XXVII, § 2756, Aug. 13, 1981,
95 Stat. 931; Pub. L. 99–92, § 6, Aug. 16, 1985, 99 Stat. 395;
Pub. L. 100–607, title VII, § 711, Nov. 4, 1988, 102 Stat.
3159; Pub. L. 102–408, title II, § 206, Oct. 13, 1992, 106 Stat.
2073; Pub. L. 103–43, title XX, § 2014(f), June 10, 1993, 107
Stat. 217, authorized grants for traineeships for advanced education of professional nurses.
Section 297–1, act July 1, 1944, ch. 373, title VIII, § 831,
as added Pub. L. 96–76, title I, § 111, Sept. 29, 1979, 93
Stat. 580; amended Pub. L. 97–414, § 8(l), Jan. 4, 1983, 96
Stat. 2061; Pub. L. 99–92, § 7, Aug. 16, 1985, 99 Stat. 396;
Pub. L. 100–607, title VII, § 712, Nov. 4, 1988, 102 Stat.
3160; Pub. L. 102–408, title II, § 207, Oct. 13, 1992, 106 Stat.
2074, authorized grants for training of nurse anesthetists.

PART E—STUDENT LOANS
AMENDMENTS
1998—Pub. L. 105–392, title I, § 123(2), Nov. 13, 1998, 112
Stat. 3562, redesignated subpart II of part B as part E.
1975—Pub. L. 94–63, title IX, § 941(g)(3), July 29, 1975, 89
Stat. 365, inserted subpart II heading.

§ 297a. Student loan fund
(a) Agreements to establish and operate fund authorized
The Secretary is authorized to enter into an
agreement for the establishment and operation
of a student loan fund in accordance with this
part with any public or nonprofit private school
of nursing which is located in a State.
(b) Provisions of agreements
Each agreement entered into under this section shall—
(1) provide for establishment of a student
loan fund by the school;
(2) provide for deposit in the fund, except as
provided in section 298d of this title, of (A) the
Federal capital contributions paid from allotments under section 297d of this title to the
school by the Secretary, (B) an additional
amount from other sources equal to not less
than one-ninth of such Federal capital contributions, (C) collections of principal and interest on loans made from the fund, (D) collections pursuant to section 297b(f) of this title,
and (E) any other earnings of the fund;
(3) provide that the fund, except as provided
in section 298d of this title, shall be used only
for loans to students of the school in accordance with the agreement and for costs of collection of such loans and interest thereon;
(4) provide that loans may be made from
such fund only to students pursuing a fulltime or half-time course of study at the school
leading to a baccalaureate or associate degree
in nursing or an equivalent degree or a diploma in nursing, or to a graduate degree in
nursing; and

§ 297a

(5) contain such other provisions as are necessary to protect the financial interests of the
United States.
(c) Regulatory standards applicable to collection
of loans
(1) Any standard established by the Secretary
by regulation for the collection by schools of
nursing of loans made pursuant to loan agreements under this part shall provide that the
failure of any such school to collect such loans
shall be measured in accordance with this subsection. With respect to the student loan fund
established pursuant to such agreements, this
subsection may not be construed to require such
schools to reimburse such loan fund for loans
that became uncollectable prior to 1983.
(2) The measurement of a school’s failure to
collect loans made under this part shall be the
ratio (stated as a percentage) that the defaulted
principal amount outstanding of such school
bears to the matured loans of such school.
(3) For purposes of this subsection—
(A) the term ‘‘default’’ means the failure of
a borrower of a loan made under this part to—
(i) make an installment payment when
due; or
(ii) comply with any other term of the
promissory note for such loan,
except that a loan made under this part shall
not be considered to be in default if the loan
is discharged in bankruptcy or if the school
reasonably concludes from written contacts
with the borrower that the borrower intends
to repay the loan;
(B) the term ‘‘defaulted principal amount
outstanding’’ means the total amount borrowed from the loan fund of a school that has
reached the repayment stage (minus any principal amount repaid or cancelled) on loans—
(i) repayable monthly and in default for at
least 120 days; and
(ii) repayable less frequently than monthly
and in default for at least 180 days;
(C) the term ‘‘grace period’’ means the period of nine months beginning on the date on
which the borrower ceases to pursue a fulltime or half-time course of study at a school
of nursing; and
(D) the term ‘‘matured loans’’ means the
total principal amount of all loans made by a
school of nursing under this part minus the
total principal amount of loans made by such
school to students who are—
(i) enrolled in a full-time or half-time
course of study at such school; or
(ii) in their grace period.
(July 1, 1944, ch. 373, title VIII, § 835, formerly
§ 822, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 913; amended Pub. L. 90–490, title II,
§ 222(a), (c)(2), Aug. 16, 1968, 82 Stat. 783, 784; Pub.
L. 92–158, § 6(d)(3), (e), Nov. 18, 1971, 85 Stat. 478;
Pub. L. 93–385, § 3(b), Aug. 23, 1974, 88 Stat. 741;
renumbered § 835 and amended Pub. L. 94–63,
title IX, §§ 936(a), 941(h)(1)–(3), (i)(1), (2), July 29,
1975, 89 Stat. 362, 365, 366; Pub. L. 96–76, title I,
§ 109(a), Sept. 29, 1979, 93 Stat. 579; Pub. L. 97–35,
title XXVII, § 2757(a), Aug. 13, 1981, 95 Stat. 931;
Pub. L. 99–92, § 8(a), Aug. 16, 1985, 99 Stat. 397;
Pub. L. 99–129, title II, § 209(j)(2), Oct. 22, 1985, 99

§ 297b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 536; Pub. L. 100–607, title VII, § 713(a), Nov.
4, 1988, 102 Stat. 3160; Pub. L. 111–148, title V,
§ 5310(b)(2), (6), Mar. 23, 2010, 124 Stat. 631.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5310(b)(2), substituted ‘‘this part’’ for ‘‘this subpart’’.
Subsec. (b). Pub. L. 111–148, § 5310(b)(6), substituted
‘‘298d’’ for ‘‘297h’’ in pars. (2) and (3).
Subsec. (c). Pub. L. 111–148, § 5310(b)(2), substituted
‘‘this part’’ for ‘‘this subpart’’ wherever appearing.
1988—Subsec. (c)(1). Pub. L. 100–607 inserted provisions relating to reimbursement of student loan fund
for certain uncollectable loans.
1985—Subsec. (c). Pub. L. 99–92 added subsec. (c).
Subsec. (c)(3)(C). Pub. L. 99–129, § 209(j)(2)(A), substituted provisions defining ‘‘grace period’’ as the period of nine months beginning on the date on which the
borrower ceases to pursue a full-time or half-time
course of study at a school of nursing for former provisions defining ‘‘grace period’’ as the period of one year
beginning on (i) the date on which the borrower ceased
to pursue a full-time or half-time course of study at a
school of nursing; or (ii) the date on which ended any
period described in clause (A) or (B) of section 297b(b)(2)
of this title which was applicable to such borrower,
whichever was later.
Subsec. (c)(3)(D)(ii). Pub. L. 99–129, § 209(j)(2)(B),
struck out ‘‘first’’ before ‘‘grace period.’’
1981—Subsec. (b)(4). Pub. L. 97–35 struck out provisions respecting prohibition on loans to students attending school before Oct. 1, 1980.
1979—Subsec. (b)(4). Pub. L. 96–76 substituted ‘‘1980’’
for ‘‘1978’’.
1975—Subsec. (a). Pub. L. 94–63, § 941(h)(1), (2), substituted ‘‘subpart’’ for ‘‘part’’ and struck out ‘‘of
Health, Education, and Welfare’’ after ‘‘Secretary’’.
Subsec. (b). Pub. L. 94–63, §§ 936(a), 941(h)(3), (i)(2), in
cl. (2) substituted ‘‘from allotments under section 297d
of this title’’ for ‘‘under this part’’, in cl. (4) substituted
‘‘October 1, 1978’’ for ‘‘July 1, 1975’’, and in cls. (2) and
(3) substituted references to sections 836 and 841 of the
Act for references to sections 823 and 829, which had
previously been translated as sections 297b and 297h of
this title, respectively, requiring no further translations in the text as a result of the renumbering of the
Public Health Service Act.
1974—Subsec. (b)(4). Pub. L. 93–385 substituted ‘‘1975’’
for ‘‘1974’’.
1971—Subsec. (b)(4). Pub. L. 92–158 substituted ‘‘fulltime or half-time course of study’’ for ‘‘full-time course
of study’’ and ‘‘1974’’ for ‘‘1971’’.
1968—Subsec. (b)(2). Pub. L. 90–490, § 222(a)(1), (c)(2),
inserted ‘‘, except as provided in section 297h of this
title,’’ after ‘‘fund’’ where first appearing and added cl.
(D) and redesignated former cl. (D) as (E), respectively.
Subsec. (b)(3). Pub. L. 90–490, § 222(a)(1), inserted
‘‘, except as provided in section 297h of this title’’ after
‘‘fund’’ where first appearing and authorized the cancellation of an additional 50 per centum of a nursery
student loan.
Subsec. (b)(4). Pub. L. 90–490, § 222(a)(2), substituted
‘‘1971’’ for ‘‘1969’’.
EFFECTIVE DATE OF 1985 AMENDMENTS
Amendment by Pub. L. 99–129 effective June 30, 1984,
see section 228(b)(5) of Pub. L. 99–129, set out as a note
under section 254l of this title.
Section 10 of Pub. L. 99–92 provided that:
‘‘(a) Except as provided in subsection (b), this Act
[enacting section 297i of this title, transferring section
296c to section 298b–5 of this title, amending this section, sections 296k, 296l, 296m, 297, 297–1, 297b, 297d, 297e,
298, 298b, and 298b–5 of this title, sections 1332, 1333,
1336, and 1341 of Title 15, Commerce and Trade, and section 6103 of Title 26, Internal Revenue Code, repealing
sections 296 to 296b, 296d to 296f, 296j, 297h, and 297j of
this title, and enacting provisions set out as notes
under sections 201 and 298b–5 of this title and section

Page 848

1333 of Title 15] and the amendments and repeals made
by this Act shall take effect on October 1, 1985.
‘‘(b)(1) The provisions of section 9(c) of this Act
[transferring section 296c of this title to section 298b–5
of this title, amending section 298b–5 of this title, and
enacting provisions set out as notes under section
298b–5 of this title] and the amendment made by paragraph (1) of such section shall take effect on the date
of enactment of this Act [Aug. 16, 1985].
‘‘(2) The amendment made by section 8(a) of this Act
[amending section 297a of this title] shall take effect
June 30, 1984.’’
EFFECTIVE DATE OF 1975 AMENDMENT
Pub. L. 94–63, title IX, § 905, July 29, 1975, 89 Stat. 355,
provided that: ‘‘Except as may otherwise be specifically
provided, the amendments made by this part [part B
(§§ 905–937) of title IX of Pub. L. 94–63, enacting sections
296j to 296m of this title, amending sections 296, 296a,
296d, 296e, 297 to 297c, 297e, and 297j of this title, repealing sections 296d, 296g, 296i, 297f, and 298c–7 of this title,
and enacting provisions set out as notes under sections
296, 296a, 296d, 296e, 296m, 297, 297b, and 297f of this title]
shall take effect July 1, 1975. The amendments made by
this part to provisions of title VIII of the Public Health
Service Act [this subchapter] (hereinafter in this part
referred to as the ‘Act’) are made to such provisions as
amended by part A of this title [amending sections 296,
296d, 296e, 296g, 296i, 297j, and 298c–7 of this title].’’
Pub. L. 94–63, title IX, § 942, July 29, 1975, 89 Stat. 367,
provided that: ‘‘The amendments made by section 941
[enacting section 298b–3 of this title, amending sections
296a to 296d, 296f, 297a to 297e, 297g to 297k, 298, and 298b
of this title, and repealing section 298c–8 of this title]
shall take effect July 1, 1975. Except as otherwise specifically provided, the amendments made by section 941
to provisions of title VIII of the Act [this subchapter]
are made to such provisions as in effect July 1, 1975,
and as amended by part B of this title [see note set out
above].’’
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by section 222(c)(2) of Pub. L. 90–490 applicable with respect to loans made after June 30, 1969,
see section 222(i) of Pub. L. 90–490, set out as a note
under section 297b of this title.

§ 297b. Loan provisions
(a) Maximum amount per individual per year;
preference to first year students
The total of the loans for any academic year
(or its equivalent, as determined under regulations of the Secretary) made by schools of nursing from loan funds established pursuant to
agreements under this part may not exceed
$3,300 in the case of any student, except that for
the final two academic years of the program involved, such total may not exceed $5,200. The aggregate of the loans for all years from such
funds may not exceed $17,000 in the case of any
student during fiscal years 2010 and 2011. After
fiscal year 2011, such amounts shall be adjusted
to provide for a cost-of-attendance increase for
the yearly loan rate and the aggregate of the
loans. In the granting of such loans, a school
shall give preference to licensed practical
nurses, to persons with exceptional financial
need, and to persons who enter as first-year students after enactment of this subchapter.
(b) Terms and conditions
Loans from any such student loan fund by any
school shall be made on such terms and conditions as the school may determine; subject, however, to such conditions, limitations, and re-

Page 849

TITLE 42—THE PUBLIC HEALTH AND WELFARE

quirements as the Secretary may prescribe (by
regulation or in the agreement with the school)
with a view to preventing impairment of the
capital of such fund to the maximum extent
practicable in the light of the objective of enabling the student to complete his course of study;
and except that—
(1) such a loan may be made only to a student who (A) is in need of the amount of the
loan to pursue a full-time or half-time course
of study at the school leading to a baccalaureate or associate degree in nursing or an
equivalent degree, or a diploma in nursing, or
a graduate degree in nursing, (B) is capable, in
the opinion of the school, of maintaining good
standing in such course of study, and (C) with
respect to any student enrolling in the school
after June 30, 2000, is of financial need (as defined in regulations issued by the Secretary);; 1
(2) such a loan shall be repayable in equal or
graduated periodic installments (with the
right of the borrower to accelerate repayment)
over the ten-year period which begins nine
months after the student ceases to pursue a
full-time or half-time course of study at a
school of nursing, excluding from such 10-year
period all (A) periods (up to three years) of (i)
active duty performed by the borrower as a
member of a uniformed service, or (ii) service
as a volunteer under the Peace Corps Act [22
U.S.C. 2501 et seq.], (B) periods (up to ten
years) during which the borrower is pursuing a
full-time or half-time course of study at a collegiate school of nursing leading to baccalaureate degree in nursing or an equivalent degree, or to graduate degree in nursing, or is
otherwise pursuing advanced professional
training in nursing (or training to be a nurse
anesthetist), and (C) such additional periods
under the terms of paragraph (8) of this subsection;
(3) in the case of a student who received such
a loan before September 29, 1995, an amount up
to 85 per centum of any such loan made before
such date (plus interest thereon) shall be canceled for full-time employment as a professional nurse (including teaching in any of the
fields of nurse training and service as an administrator, supervisor, or consultant in any
of the fields of nursing) in any public or nonprofit private agency, institution, or organization (including neighborhood health centers),
at the rate of 15 per centum of the amount of
such loan (plus interest) unpaid on the first
day of such service for each of the first, second, and third complete year of such service,
and 20 per centum of such amount (plus interest) for each complete fourth and fifth year of
such service;
(4) the liability to repay the unpaid balance
of such loan and accrued interest thereon shall
be canceled upon the death of the borrower, or
if the Secretary determines that he has become permanently and totally disabled;
(5) such a loan shall bear interest on the unpaid balance of the loan, computed only for periods during which the loan is repayable, at
the rate of 5 percent per annum;
(6) such a loan shall be made without security or endorsement, except that if the bor1 So

in original.

§ 297b

rower is a minor and the note or other evidence of obligation executed by him would
not, under the applicable law, create a binding
obligation, either security or endorsement
may be required;
(7) no note or other evidence of any such
loan may be transferred or assigned by the
school making the loan except that, if the borrower transfers to another school participating in the program under this part such note
or other evidence of a loan may be transferred
to such other school; and
(8) pursuant to uniform criteria established
by the Secretary, the repayment period established under paragraph (2) for any student borrower who during the repayment period failed
to make consecutive payments and who, during the last 12 months of the repayment period, has made at least 12 consecutive payments may be extended for a period not to exceed 10 years.
(c) Cancellation
Where all or any part of a loan, or interest, is
canceled under this section, the Secretary shall
pay to the school an amount equal to the
school’s proportionate share of the canceled portion, as determined by the Secretary.
(d) Installments
Any loan for any year by a school from a student loan fund established pursuant to an agreement under this part shall be made in such installments as may be provided in regulations of
the Secretary or such agreement and, upon notice to the Secretary by the school that any recipient of a loan is failing to maintain satisfactory standing, any or all further installments of
his loan shall be withheld, as may be appropriate.
(e) Availability to eligible students in need
An agreement under this part with any school
shall include provisions designed to make loans
from the student loan fund established thereunder reasonably available (to the extent of the
available funds in such fund) to all eligible students in the school in need thereof.
(f) Penalty for late payment
Subject to regulations of the Secretary and in
accordance with this section, a school shall assess a charge with respect to a loan from the
loan fund established pursuant to an agreement
under this part for failure of the borrower to pay
all or any part of an installment when it is due
and, in the case of a borrower who is entitled to
deferment of the loan under subsection (b)(2) of
this section or cancellation of part or all of the
loan under subsection (b)(3) of this section, for
any failure to file timely and satisfactory evidence of such entitlement. No such charge may
be made if the payment of such installment or
the filing of such evidence is made within 60
days after the date on which such installment or
filing is due. The amount of any such charge
may not exceed an amount equal to 6 percent of
the amount of such installment. The school may
elect to add the amount of any such charge to
the principal amount of the loan as of the first
day after the day on which such installment or
evidence was due, or to make the amount of the

§ 297b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

charge payable to the school not later than the
due date of the next installment after receipt by
the borrower of notice of the assessment of the
charge.
(g) Minimum monthly repayment
A school may provide in accordance with regulations of the Secretary, that during the repayment period of a loan from a loan fund established pursuant to an agreement under this part
payments of principal and interest by the borrower with respect to all the outstanding loans
made to him from loan funds so established
shall be at a rate equal to not less than $40 per
month.
(h) Loan cancellation
Notwithstanding the amendment made by section 6(b) of the Nurse Training Act of 1971 to
this section—
(A) any person who obtained one or more
loans from a loan fund established under this
part, who before November 18, 1971, became eligible for cancellation of all or part of such
loans (including accrued interest) under this
section (as in effect on the day before such
date), and who on such date was not engaged
in a service for which loan cancellation was
authorized under this section (as so in effect),
may at any time elect to receive such cancellation in accordance with this subsection
(as so in effect); and
(B) in the case of any person who obtained
one or more loans from a loan fund established
under this part and who on such date was engaged in a service for which cancellation of all
or part of such loans (including accrued interest) was authorized under this section (as so in
effect), this section (as so in effect) shall continue to apply to such person for purposes of
providing such loan cancellation until he terminates such service.
(i) Loan repayment
Upon application by a person who received,
and is under an obligation to repay, any loan
made to such person as a nursing student, the
Secretary may undertake to repay (without liability to the applicant) all or any part of such
loan, and any interest or portion thereof outstanding thereon, upon his determination, pursuant to regulations establishing criteria therefor, that the applicant—
(1) failed to complete the nursing studies
with respect to which such loan was made;
(2) is in exceptionally needy circumstances;
and
(3) has not resumed, or cannot reasonably be
expected to resume, such nursing studies within two years following the date upon which the
applicant terminated the studies with respect
to which such loan was made.
(j) Collection by Secretary of loan in default; preconditions and procedures applicable
The Secretary is authorized to attempt to collect any loan which was made under this part,
which is in default, and which was referred to
the Secretary by a school of nursing with which
the Secretary has an agreement under this part,
on behalf of that school under such terms and
conditions as the Secretary may prescribe (in-

Page 850

cluding reimbursement from the school’s student loan fund for expenses the Secretary may
reasonably incur in attempting collection), but
only if the school has complied with such requirements as the Secretary may specify by regulation with respect to the collection of loans
under this part. A loan so referred shall be treated as a debt subject to section 5514 of title 5.
Amounts collected shall be deposited in the
school’s student loan fund. Whenever the Secretary desires the institution of a civil action
regarding any such loan, the Secretary shall
refer the matter to the Attorney General for appropriate action.
(k) Elimination of statute of limitation for loan
collections
(1) Purpose
It is the purpose of this subsection to ensure
that obligations to repay loans under this section are enforced without regard to any Federal or State statutory, regulatory, or administrative limitation on the period within
which debts may be enforced.
(2) Prohibition
Notwithstanding any other provision of Federal or State law, no limitation shall terminate the period within which suit may be filed,
a judgment may be enforced, or an offset, garnishment, or other action may be initiated or
taken by a school of nursing that has an
agreement with the Secretary pursuant to section 297a of this title that is seeking the repayment of the amount due from a borrower
on a loan made under this part after the default of the borrower on such loan.
(July 1, 1944, ch. 373, title VIII, § 836, formerly
§ 823, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 914; amended Pub. L. 89–290, § 4(g)(2), Oct.
22, 1965, 79 Stat. 1058; Pub. L. 90–490, title II,
§ 222(b), (c)(1), Aug. 16, 1968, 82 Stat. 783, 784; Pub.
L. 92–158, § 6(a), (b)(1), (e), Nov. 18, 1971, 85 Stat.
475, 476, 478; renumbered § 836 and amended Pub.
L. 94–63, title IX, §§ 936(b), 941(h)(1), (2), (5), (i)(1),
July 29, 1975, 89 Stat. 363, 365; Pub. L. 96–76, title
I, § 112, Sept. 29, 1979, 93 Stat. 580; Pub. L. 97–35,
title XXVII, § 2757(b), Aug. 13, 1981, 95 Stat. 931;
Pub. L. 99–92, § 8(b)–(d), Aug. 16, 1985, 99 Stat. 398;
Pub. L. 100–607, title VII, §§ 713(b)–(g), 714(a)–(c),
Nov. 4, 1988, 102 Stat. 3160, 3161; Pub. L. 101–93,
§ 5(r), Aug. 16, 1989, 103 Stat. 614; Pub. L. 102–408,
title II, § 211(a)(1), Oct. 13, 1992, 106 Stat. 2078;
Pub. L. 105–392, title I, § 133(a)–(c)(1), Nov. 13,
1998, 112 Stat. 3575; Pub. L. 111–148, title V,
§§ 5202, 5310(b)(2)–(4), Mar. 23, 2010, 124 Stat. 607,
631.)
REFERENCES IN TEXT
The Peace Corps Act, referred to in subsec. (b)(2), is
Pub. L. 87–293, Sept. 22, 1961, 75 Stat. 612, as amended,
which is classified principally to chapter 34 (§ 2501 et
seq.) of Title 22, Foreign Relations and Intercourse. For
complete classification of this Act to the Code, see
Short Title note set out under section 2501 of Title 22
and Tables.
Section 6(b) of the Nurse Training Act of 1971, referred to in subsec. (h), is section 6(b) of Pub. L. 92–158,
Nov. 18, 1971, 85 Stat. 477. Section 6(b)(1) amended subsec. (b)(3) of this section, added former subsec. (h) of
this section, and enacted the provisions editorially
classified to subsec. (i) [now (h)] of this section. Section

Page 851

TITLE 42—THE PUBLIC HEALTH AND WELFARE

6(b)(2) enacted section 297i of this title which was
transferred and redesignated as subsec. (j) [now (i)] of
this section pursuant to section 941(h)(5) of Pub. L.
94–63.
CODIFICATION
Provisions of subsec. (h) of this section were, in the
original, enacted by section 6(b)(1) of Pub. L. 92–158,
without directory language with respect to classification in the Code and were editorially set out as subsec.
(i) [now (h)] as the probable intent of Congress.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5310(b)(2), substituted ‘‘this part’’ for ‘‘this subpart’’.
Pub. L. 111–148, § 5202(a), substituted ‘‘$3,300’’ for
‘‘$2,500’’, ‘‘$5,200’’ for ‘‘$4,000’’, and ‘‘$17,000 in the case of
any student during fiscal years 2010 and 2011. After fiscal year 2011, such amounts shall be adjusted to provide
for a cost-of-attendance increase for the yearly loan
rate and the aggregate of the loans.’’ for ‘‘$13,000 in the
case of any student.’’
Subsec. (b)(1)(C). Pub. L. 111–148, § 5202(b)(1), substituted ‘‘2000’’ for ‘‘1986’’.
Subsec. (b)(3). Pub. L. 111–148, § 5202(b)(2), substituted
‘‘September 29, 1995’’ for ‘‘September 29, 1979’’.
Subsecs. (b)(7), (d) to (g). Pub. L. 111–148, § 5310(b)(2),
substituted ‘‘this part’’ for ‘‘this subpart’’.
Subsec. (h). Pub. L. 111–148, § 5310(b)(3), struck out
concluding provisions which read as follows: ‘‘Nothing
in this subsection shall be construed to prevent any
person from entering into an agreement for loan cancellation under subsection (h) of this section (as
amended by section 6(b)(2) of the Nurse Training Act of
1971).’’
Pub. L. 111–148, § 5310(b)(2), substituted ‘‘this part’’ for
‘‘this subpart’’ in two places.
Subsec. (j). Pub. L. 111–148, § 5310(b)(2), substituted
‘‘this part’’ for ‘‘this subpart’’ wherever appearing.
Subsecs. (k), (l). Pub. L. 111–148, § 5310(b)(4), redesignated subsec. (l) as (k).
Subsec. (l)(2). Pub. L. 111–148, § 5310(b)(2), substituted
‘‘this part’’ for ‘‘this subpart’’.
1998—Subsec. (b)(1). Pub. L. 105–392, § 133(a)(1), substituted semicolon for period at end.
Subsec. (b)(2)(C). Pub. L. 105–392, § 133(a)(2), added subpar. (C).
Subsec. (b)(8). Pub. L. 105–392, § 133(a)(3), (4), added
par. (8).
Subsec. (g). Pub. L. 105–392, § 133(b), substituted ‘‘$40’’
for ‘‘$15’’.
Subsec. (l). Pub. L. 105–392, § 133(c)(1), added subsec.
(l).
1992—Subsecs. (h) to (k). Pub. L. 102–408 redesignated
subsecs. (i) to (k) as (h) to (j), respectively, and struck
out former subsec. (h) which provided for a loan repayment program. See section 297n of this title.
1989—Subsec. (h)(6)(C). Pub. L. 101–93 substituted
‘‘means a skilled nursing facility, as such term is defined in section 1395x(j) of this title, and an intermediate care facility, as such term is defined in section
1396d(c) of this title’’ for ‘‘means an intermediate care
facility and a skilled nursing facility, as such terms are
defined in subsections (c) and (i), respectively, of section 1396d of this title’’.
1988—Subsec. (a). Pub. L. 100–607, § 713(b), (c), inserted
in first sentence ‘‘, except that for the final two academic years of the program involved, such total may
not exceed $4,000’’, substituted ‘‘$13,000’’ for ‘‘$10,000’’ in
second sentence, and inserted ‘‘, to persons with exceptional financial need,’’ after ‘‘nurses’’ in third sentence.
Subsec. (b)(1)(C). Pub. L. 100–607, § 713(d), amended
subpar. (C) generally. Prior to amendment, subpar. (C)
read as follows: ‘‘if a student who will enroll in the
school after June 30, 1986, is of exceptional financial
need (as defined by regulations of the Secretary)’’.
Subsec. (b)(2)(B). Pub. L. 100–607, § 713(e), substituted
‘‘ten’’ for ‘‘five’’ and inserted ‘‘or half-time’’ after ‘‘a
full-time’’.

§ 297b

Subsec. (b)(5). Pub. L. 100–607, § 713(f), substituted ‘‘5
percent’’ for ‘‘6 per centum’’.
Subsec. (h)(1)(C). Pub. L. 100–607, § 714(a), amended
subpar. (C) generally. Prior to amendment, subpar. (C)
read as follows: ‘‘who enters into an agreement with
the Secretary to serve as a nurse for a period of at least
two years in an area in a State determined by the Secretary, after consultation with the appropriate State
health authority (as determined by the Secretary by
regulations), to have a shortage of and need for
nurses;’’.
Subsecs. (h)(5), (6). Pub. L. 100–607, § 714(b), (c), added
pars. (5) and (6).
Subsec. (j)(2) to (4). Pub. L. 100–607, § 713(g), redesignated par. (4) as (3) and struck out former par. (3) which
related to low-income or disadvantaged family.
1985—Subsec. (b)(1). Pub. L. 99–92, § 8(b), which directed that cl. (C) be inserted before period, was executed by inserting cl. (C) before the semicolon as the
probable intent of Congress.
Subsec. (f). Pub. L. 99–92, § 8(c), substituted ‘‘the Secretary and in accordance with this section, a school
shall’’ for ‘‘the Secretary, a school may’’, and substituted provisions relating to charges not allowed in
certain cases and allowed where payment is late for
provisions relating to maximum amount of late
charges.
Subsec. (k). Pub. L. 99–92, § 8(d), added subsec. (k).
1981—Subsec. (b)(5). Pub. L. 97–35 substituted ‘‘6’’ for
‘‘3’’.
1979—Subsec. (b)(3). Pub. L. 96–76 inserted provisions
requiring conditions to be applicable to loans arising
prior to Sept. 29, 1979.
1975—Subsec. (a). Pub. L. 94–63, § 941(h)(1), substituted
‘‘subpart’’ for ‘‘part’’.
Subsec. (b). Pub. L. 94–63, § 941(h)(2), struck out ‘‘of
Health, Education, and Welfare’’ after ‘‘Secretary’’.
Subsec. (b)(2)(B). Pub. L. 94–63, § 936(b), inserted ‘‘(or
training to be a nurse anesthetist)’’ after ‘‘professional
training in nursing’’.
Subsec. (b)(7). Pub. L. 94–63, § 941(h)(1), substituted
‘‘subpart’’ for ‘‘part’’.
Subsec. (c). Pub. L. 94–63, § 941(h)(2), struck out ‘‘of
Health, Education, and Welfare’’ after ‘‘Secretary’’.
Subsecs. (d) to (i). Pub. L. 94–63, § 941(h)(1), substituted ‘‘subpart’’ for ‘‘part’’ whenever appearing.
Subsec. (j). Pub. L. 94–63, § 941(h)(5), added subsec. (j),
formerly classified as section 297i of this title pursuant
to enactment as section 830 of act July 1, 1944, ch. 373.
Section 941(h)(5)(A) of Pub. L. 94–63 transferred such
former section to this section and section 941(h)(5)(B)
redesignated provision as subsec. (j).
1971—Subsec. (a). Pub. L. 92–158, § 6(a), substituted
‘‘$2,500’’ for ‘‘$1,500’’ and ‘‘$10,000’’ for ‘‘$60,000’’.
Subsec. (b)(1). Pub. L. 92–158, § 6(e), substituted ‘‘fulltime or half-time course of study’’ for ‘‘full-time course
of study’’.
Subsec. (b)(2). Pub. L. 92–158, § 6(e), in text preceding
cl. (A), substituted ‘‘full-time or half-time course of
study’’ for ‘‘full-time course of study’’.
Subsec. (b)(3). Pub. L. 92–158, § 6(b)(1)(A), substituted
provisions cancelling up to 85 per centum of loan, for
provisions cancelling up to 50 per centum of loan,
where borrower holds full-time employment as a professional nurse, added to areas of possible employment
under this par. by inserting reference to any public or
nonprofit organization including neighborhood health
centers, substituted, with regard to the rate of cancellation of loan, the rate of 15 per centum of the
amount unpaid on the first day of service, continuing
at such rate with each of the first, second and third
complete years of such service and 20 per centum of
such amount with each complete fourth and fifth year
of service for the rate of 10 per centum of the amount
unpaid on the first day of service and to continue with
each complete year of service, and struck out reference
to 15 per centum rate of cancellation per complete year
of service plus, for the purpose of such higher rate, the
cancellation of an additional 50 per centum of such loan
where such service is in a public or nonprofit hospital

§ 297c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

in any area which is determined, in accordance with
the regulations of the Secretary, to be in an area having a substantial shortage of such nurses at such hospitals.
Subsec. (h). Pub. L. 92–158, § 6(b)(1)(B), added subsec.
(h).
1968—Subsec. (a). Pub. L. 90–490, § 222(b)(1), increased
limitation on amount of annual loans per student from
$1,000 to $1,500, required preferences in granting of
loans to licensed practical nurses, and limited aggregate of loans for all years to any one student to $6,000.
Subsec. (b)(2). Pub. L. 90–490, § 222(b)(2), provided for
commencement of repayment nine months, rather than
one year, after student ceases to pursue full-time
course of study, excluded from ten-year repayment period periods (up to three years) of active duty as member of a uniformed service or Peace Corps volunteer
service and periods (up to five years) as undergraduate
or graduate degree student in nursing, including advanced professional training in nursing, and struck out
prohibition against accrual of interest on loans.
Subsec. (b)(3). Pub. L. 90–490, § 222(b)(3), authorized
cancellation of an additional 50 per centum of a nursing
student loan (plus interest) at rate of 15 per centum for
each complete year of service in a public or other nonprofit hospital in an area with a substantial shortage of
nurses.
Subsec. (b)(5). Pub. L. 90–490, § 222(b)(4), struck out
provisions for an interest rate which is the greater of
3 per centum or the going Federal rate at time loan is
made, defining going Federal rate, and making rate determined for first loan applicable to any subsequent
loan.
Subsecs. (f), (g). Pub. L. 90–490, § 222(c)(1), added subsecs. (f) and (g).
1965—Subsec. (b)(5). Pub. L. 89–290 applied rate of interest for first loan obtained by a student from a loan
fund established under this part to any subsequent loan
to such student from such fund during his course of
study.
EFFECTIVE DATE OF 1998 AMENDMENT
Pub. L. 105–392, title I, § 133(c)(2), Nov. 13, 1998, 112
Stat. 3576, provided that: ‘‘The amendment made by
paragraph (1) [amending this section] shall be effective
with respect to actions pending on or after the date of
enactment of this Act [Nov. 13, 1998].’’
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99–92 effective Oct. 1, 1985, see
section 10(a) of Pub. L. 99–92, set out as a note under
section 297a of this title.
EFFECTIVE DATE OF 1975 AMENDMENT
Section 936(b) of Pub. L. 94–63 provided that the
amendment made by that section is effective with respect to periods of training to be a nurse anesthetist
undertaken on or after July 29, 1975.
Amendment by section 941(h)(1), (2), (5), (i)(1) of Pub.
L. 94–63 effective July 1, 1975, see section 942 of Pub. L.
94–63, set out as a note under section 297a of this title.
EFFECTIVE DATE OF 1971 AMENDMENT
Section 6(a)(1) of Pub. L. 92–158 provided that the
amendment made by that section is effective with respect to academic years (or their equivalent as determined under regulations of the Secretary of Health,
Education, and Welfare under this section) beginning
after June 30, 1971.
EFFECTIVE DATE OF 1968 AMENDMENT
Pub. L. 90–490, title II, § 222(i), Aug. 16, 1968, 82 Stat.
785, provided that: ‘‘The amendments made by subsection (b)(1) and (2) [amending this section] shall
apply with respect to all loans made after June 30, 1969,
and with respect to loans made from a student loan
fund established under an agreement pursuant to section 822 [section 297a of this title], before July 1, 1969,
to the extent agreed to by the school which made the

Page 852

loans and the Secretary (but then only for years beginning after June 30, 1968). The amendments made by subsection (b)(4) [amending this section] and subsection (c)
[amending this section and section 297a of this title]
shall apply with respect to loans made after June 30,
1969. The amendment made by subsection (h) [enacting
section 297h of this title] shall apply with respect to appropriations for fiscal years beginning after June 30,
1969. The amendment made by subsection (b)(3) [amending this section] shall apply with respect to service,
specified in section 823(b)(3) of such Act [subsec. (b)(3)
of this section] performed during academic years beginning after the enactment of this Act, whether the loan
was made before or after such enactment [Aug. 16,
1968].’’
CONSTRUCTION OF 1992 AMENDMENT
Pub. L. 102–408, title II, § 211(b), Oct. 13, 1992, 106 Stat.
2079, provided that: ‘‘With respect to section 836(h) of
the Public Health Service Act [former subsec. (h) of
this section], as in effect prior to the date of the enactment of this Act [Oct. 13, 1992], any agreement entered
into under such section that is in effect on the day before such date remains in effect in accordance with the
terms of the agreement, notwithstanding the amendment made by subsection (a) of this section [enacting
section 297n of this title, amending this section, and repealing section 297c–1 of this title].’’

§ 297c. Repealed. Pub. L. 105–392, title I, § 123(3),
Nov. 13, 1998, 112 Stat. 3562
Section, act July 1, 1944, ch. 373, title VIII, § 837, formerly § 824, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 915; amended Pub. L. 89–751, § 6(b), Nov. 3, 1966, 80
Stat. 1235; Pub. L. 90–490, title II, § 222(d), Aug. 16, 1968,
82 Stat. 784; Pub. L. 92–52, § 3(a), July 9, 1971, 85 Stat.
144; Pub. L. 92–158, § 6(c), Nov. 18, 1971, 85 Stat. 477; Pub.
L. 93–385, § 3(a), Aug. 23, 1974, 88 Stat. 741; renumbered
§ 837 and amended Pub. L. 94–63, title IX, §§ 936(c),
941(i)(1), (3), July 29, 1975, 89 Stat. 363, 365, 366; Pub. L.
96–76, title I, § 109(b), Sept. 29, 1979, 93 Stat. 580; Pub. L.
97–35, title XXVII, § 2757(c), Aug. 13, 1981, 95 Stat. 931,
authorized appropriations for student loan funds for
certain fiscal years.

§ 297c–1. Repealed. Pub. L. 102–408, title II,
§ 211(a)(2), Oct. 13, 1992, 106 Stat. 2078
Section, act July 1, 1944, ch. 373, title VIII, § 837A, as
added Nov. 4, 1988, Pub. L. 100–607, title VII, § 714(d), 102
Stat. 3162, authorized appropriations for educational
loan repayments for service in certain health facilities.

§ 297d. Allotments and payments of Federal capital contributions
(a) Application for allotment; reduction or adjustment of amount requested in application;
reallotment; continued availability of funds
(1) The Secretary shall from time to time set
dates by which schools of nursing must file applications for Federal capital contributions.
(2)(A) If the total of the amounts requested for
any fiscal year in such applications exceeds the
total amount appropriated under section 297c 1
of this title for that fiscal year, the allotment
from such total amount to the loan fund of each
school of nursing shall be reduced to whichever
of the following is the smaller:
(i) The amount requested in its application.
(ii) An amount which bears the same ratio to
the total amount appropriated as the number
of students estimated by the Secretary to be
enrolled on a full-time basis in such school
1 See

References in Text note below.

Page 853

TITLE 42—THE PUBLIC HEALTH AND WELFARE

during such fiscal year bears to the estimated
total number of students enrolled in all such
schools on a full-time basis during such year.
(B) Amounts remaining after allotment under
subparagraph (A) shall be reallotted in accordance with clause (ii) of such subparagraph
among schools whose applications requested
more than the amounts so allotted to their loan
funds, but with such adjustments as may be necessary to prevent the total allotted to any such
school’s loan fund under this paragraph and
paragraph (3) from exceeding the total so requested by it.
(3) Funds which, pursuant to section 297e(c) of
this title or pursuant to a loan agreement under
section 297a of this title are returned to the Secretary in any fiscal year, shall be available for
allotment until expended. Funds described in
the preceding sentence shall be allotted among
schools of nursing in such manner as the Secretary determines will best carry out this part.
(b) Installment payment of allotments
Allotments to a loan fund of a school shall be
paid to it from time to time in such installments as the Secretary determines will not result in unnecessary accumulations in the loan
fund at such school.
(c) Manner of payment
The Federal capital contributions to a loan
fund of a school under this part shall be paid to
it from time to time in such installments as the
Secretary determines will not result in unnecessary accumulations in the loan fund at such
school.
(July 1, 1944, ch. 373, title VIII, § 838, formerly
§ 825, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 915; amended Pub. L. 89–751, § 6(c), Nov. 3,
1966, 80 Stat. 1235; Pub. L. 90–490, title II, § 222(e),
Aug. 16, 1968, 82 Stat. 785; renumbered § 838 and
amended Pub. L. 94–63, title IX, § 941(h)(1), (2),
(4)(A), (i)(1), (4), July 29, 1975, 89 Stat. 365, 366;
Pub. L. 99–92, § 8(e), Aug. 16, 1985, 99 Stat. 398;
Pub. L. 100–607, title VII, § 713(h)(1), Nov. 4, 1988,
102 Stat. 3161; Pub. L. 102–408, title II, § 208(a),
Oct. 13, 1992, 106 Stat. 2075; Pub. L. 111–148, title
V, § 5310(b)(2), Mar. 23, 2010, 124 Stat. 631.)
REFERENCES IN TEXT
Section 297c of this title, referred to in subsec.
(a)(2)(A), was repealed by Pub. L. 105–392, title I, § 123(3),
Nov. 13, 1998, 112 Stat. 3562.
AMENDMENTS
2010—Subsecs. (a)(3), (c). Pub. L. 111–148 substituted
‘‘this part’’ for ‘‘this subpart’’.
1992—Subsec. (a)(3). Pub. L. 102–408 struck out ‘‘(A)’’
after ‘‘(3)’’, substituted ‘‘available for allotment until
expended.’’ for ‘‘available for allotment in such fiscal
year and in the fiscal year succeeding the fiscal year.’’
and ‘‘this subpart.’’ for ‘‘this subpart, except that in
making such allotments, the Secretary shall give priority to schools of nursing which established student loan
funds under this subpart after September 30, 1975.’’, and
struck out subpar. (B) which read as follows: ‘‘With respect to funds available pursuant to subparagraph (A),
any such funds returned to the Secretary and not allotted by the Secretary, during the period of availability
specified in such subparagraph, shall be available to
carry out section 297j of this title and, for such purpose,
shall remain available until expended.’’
1988—Subsec. (a)(3). Pub. L. 100–607 designated existing provisions as subpar. (A) and added subpar. (B).

§ 297d

1985—Subsec. (a). Pub. L. 99–92 amended subsec. (a)
generally, substituting provisions relating to application for allotment, reduction or adjustment of amount
requested in application, reallotment, and availability
of funds for allotment during fiscal years for provisions
relating to determination of amount of allotment.
Subsec. (b). Pub. L. 99–92 amended subsec. (b) generally, substituting provisions relating to payment to a
loan fund of a school of allotments for provisions relating to application for allotment, adjustment or reduction of amount requested in application, and reallotment.
1975—Subsec. (a). Pub. L. 94–63, § 941(h)(1), (4)(A)(i),
(i)(4), substituted ‘‘subpart’’ for ‘‘part’’ wherever appearing, struck out ‘‘(whether as Federal capital contributions or as loans to schools under section 297f of
this title)’’ before ‘‘which are in excess’’, and substituted references to section 847 of the Act for references to section 824, which had previously been translated as section 297c of this title, requiring no further
translations in text as a result of renumbering of the
Public Health Service Act.
Subsec. (b)(1). Pub. L. 94–63, § 941(h)(4)(A)(ii), struck
out ‘‘, and for loans pursuant to section 297f of this
title,’’ after ‘‘contributions’’.
Subsec. (b)(2). Pub. L. 94–63, § 941(h)(2), struck out ‘‘of
Health, Education, and Welfare’’ after ‘‘Secretary’’.
Subsec. (c). Pub. L. 94–63, § 941(h)(1), substituted ‘‘subpart’’ for ‘‘part’’.
1968—Subsec. (a). Pub. L. 90–490 substituted a new formula for distribution of Federal funds among schools of
nursing by providing for allotment of funds among the
schools entirely on the basis of their relative enrollments for former provisions which allocated funds
among the States, 50 per centum on the basis of relative number of high school graduates, and 50 per centum on the basis of relative number of students enrolled in schools of nursing, and provided for determination of number of persons enrolled in such schools
for most recent year for which satisfactory data are
available to the Secretary.
1966—Subsec. (a). Pub. L. 89–751, § 6(c)(1), authorized
allotment of appropriations for payment as Federal
capital contributions or as loans to schools under section 297f of this title, and directed that funds available
in any fiscal year for payment to schools under this
part (whether as Federal capital contributions or as
loans to schools under section 297f of this title) which
are in excess of the amount appropriated pursuant to
section 297c of this title for that year shall be allotted
among States and among schools within States in such
manner as the Secretary determinates will best carry
out the purposes of this part.
Subsec. (b)(1). Pub. L. 89–751, § 6(c)(2), substituted
‘‘schools of nursing in a State must file applications for
Federal capital contributions, and for loans pursuant
to section 297f of this title, from the allotment of such
State under the first two sentences of subsection (a) of
this section’’ for ‘‘schools of nursing with which he has
in effect agreements under this part must file applications for Federal capital contributions to their loan
funds pursuant to section 297a(b)(2)(A) of this title’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Pub. L. 100–607, title VII, § 713(h)(2), Nov. 4, 1988, 102
Stat. 3161, provided that: ‘‘Except as provided in Public
Law 100–436 [Sept. 20, 1988, 102 Stat. 1680, see Tables for
classification], the amendment made by paragraph (1)
[amending this section] shall take effect as if such
amendment had been effective on September 30, 1988,
and as if section 843 of the Public Health Service Act,
as added by section 715 of this title [section 297j of this
title], had been effective on such date.’’
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99–92 effective Oct. 1, 1985, see
section 10(a) of Pub. L. 99–92, set out as a note under
section 297a of this title.

§ 297e

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE OF 1975 AMENDMENT

Amendment by Pub. L. 94–63 effective July 1, 1975, see
section 942 of Pub. L. 94–63, set out as a note under section 297a of this title.
EFFECTIVE DATE OF 1966 AMENDMENT
Pub. L. 89–751, § 6(e)(1), Nov. 3, 1966, 80 Stat. 1236, provided that: ‘‘The amendments made by this section
[amending this section and sections 297c, 297e, and 297f
of this title] shall be effective in the case of payments
to student loan funds made after the enactment of this
Act [Nov. 3, 1966], except in the case of payments pursuant to commitments (made prior to enactment of this
Act) to make loans under section 827 of the Public
Health Service Act [section 297f of this title] as in effect prior to the enactment of this Act.’’
APPLICABILITY OF REORG. PLAN NO. 3 OF 1966
Section 9 of Pub. L. 89–751 provided that: ‘‘The
amendments made by this Act [enacting former sections 295h to 295h–5 and 298c to 298c–8 of this title and
amending this section, former sections 292b, 294d, 294n
to 294p, 296, and 297c, section 297e, former section 297f,
and section 298 of this title, and section 1717 of Title 12,
Banks and Banking] shall be subject to the provisions
of Reorganization Plan Numbered 3 of 1966 [set out as
a note under section 202 of this title].’’

§ 297e. Distribution of assets from loan funds
(a) Capital distribution of balance of loan fund
If a school terminates a loan fund established
under an agreement pursuant to section 297a(b)
of this title, or if the Secretary for good cause
terminates the agreement with the school, there
shall be a capital distribution as follows:
(1) The Secretary shall first be paid an amount
which bears the same ratio to such balance in
such fund on the date of termination of the fund
as the total amount of the Federal capital contributions to such fund by the Secretary pursuant to section 297a(b)(2)(A) of this title bears to
the total amount in such fund derived from such
Federal capital contributions and from funds deposited therein pursuant to section 297a(b)(2)(B)
of this title.
(2) The remainder of such balance shall be paid
to the school.
(b) Payment of principal or interest on loans
If a capital distribution is made under subsection (a) of this section, the school involved
shall, after such capital distribution, pay to the
Secretary, not less often than quarterly, the
same proportionate share of amounts received
by the school in payment of principal or interest
on loans made from the loan fund established
under section 297a(b) of this title as determined
by the Secretary under subsection (a) of this
section.
(c) Payment of balance of loan fund
(1) Within 90 days after the termination of any
agreement with a school under section 297a of
this title or the termination in any other manner of a school’s participation in the loan program under this part,1 such school shall pay to
the Secretary from the balance of the loan fund
of such school established under section 297a of
this title, an amount which bears the same ratio
to the balance in such fund on the date of such
termination as the total amount of the Federal
1 See

References in Text note below.

Page 854

capital contributions to such fund by the Secretary pursuant to section 297a(b)(2)(A) of this
title bears to the total amount in such fund on
such date derived from such Federal capital contributions and from funds deposited in the fund
pursuant to section 297a(b)(2)(B) of this title.
The remainder of such balance shall be paid to
the school.
(2) A school to which paragraph (1) applies
shall pay to the Secretary after the date on
which payment is made under such paragraph
and not less than quarterly, the same proportionate share of amounts received by the school
after the date of termination referred to in paragraph (1) in payment of principal or interest on
loans made from the loan fund as was determined for the Secretary under such paragraph.
(July 1, 1944, ch. 373, title VIII, § 839, formerly
§ 826, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 916; amended Pub. L. 89–751, § 6(d), Nov. 3,
1966, 80 Stat. 1235; Pub. L. 90–490, title II, § 222(f),
Aug. 16, 1968, 82 Stat. 785; Pub. L. 92–52, § 3(b),
July 9, 1971, 85 Stat. 145; Pub. L. 92–158, § 6(d)(1),
Nov. 18, 1971, 85 Stat. 478; renumbered § 839 and
amended Pub. L. 94–63, title IX, §§ 936(d),
941(h)(1), (2), (4)(B), (i)(1), (5), July 29, 1975, 89
Stat. 363, 365, 366; Pub. L. 96–32, § 7(j), July 10,
1979, 93 Stat. 84; Pub. L. 96–76, title I, § 109(c),
Sept. 29, 1979, 93 Stat. 580; Pub. L. 97–35, title
XXVII, § 2757(d), Aug. 13, 1981, 95 Stat. 931; Pub.
L. 99–92, § 8(f), Aug. 16, 1985, 99 Stat. 399; Pub. L.
100–607, title VII, § 713(i), Nov. 4, 1988, 102 Stat.
3161; Pub. L. 102–408, title II, § 208(b), Oct. 13,
1992, 106 Stat. 2075; Pub. L. 105–392, title I,
§ 133(e), Nov. 13, 1998, 112 Stat. 3577; Pub. L.
111–148, title V, § 5310(b)(5), Mar. 23, 2010, 124
Stat. 631.)
REFERENCES IN TEXT
This part, referred to in subsec. (c)(1), was in the
original ‘‘this subpart’’ and was translated to reflect
the probable intent of Congress and the redesignation
of subpart II of part B of this subchapter as part E of
this subchapter by Pub. L. 105–392, title I, § 123(2), Nov.
13, 1998, 112 Stat. 3562.
AMENDMENTS
2010—Pub. L. 111–148 made technical amendment to
section and subsec. (a) designations resulting in no
change in text.
1998—Subsec. (a). Pub. L. 105–392, § 133(e)(1)(A), added
introductory provisions and struck out former introductory provisions which read as follows: ‘‘After September 30, 1996, and not later than December 31, 1999,
there shall be a capital distribution of the balance of
the loan fund established under an agreement pursuant
to section 297a of this title by each school as follows:’’.
Subsec. (a)(1). Pub. L. 105–392, § 133(e)(1)(B), substituted ‘‘on the date of termination of the fund’’ for
‘‘at the close of September 30, 1999,’’.
Subsec. (b). Pub. L. 105–392, § 133(e)(2), amended subsec. (b) generally. Prior to amendment, subsec. (b) read
as follows: ‘‘After December 31, 1999, each school with
which the Secretary has made an agreement under this
subpart shall pay to the Secretary, not less often than
quarterly, the same proportionate share of amounts received by the school after September 30, 1999, in payment of principal or interest on loans made from the
loan fund established pursuant to such agreement as
was determined for the Secretary under subsection (a)
of this section.’’
1992—Subsec. (a). Pub. L. 102–408, § 208(b)(2), substituted ‘‘1999’’ for ‘‘1994’’ in introductory provisions
and in par. (1).

Page 855

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 102–408, § 208(b)(1), substituted ‘‘1996’’ for
‘‘1991’’ in introductory provisions.
Subsec. (b). Pub. L. 102–408, § 208(b)(2), substituted
‘‘1999’’ for ‘‘1994’’ in two places.
1988—Subsec. (a). Pub. L. 100–607, § 713(i)(1)(A), which
directed substitution of ‘‘1994’’ for ‘‘1991’’ in text preceding par. (1), was executed by making the substitution for ‘‘1991’’ the second time appearing to reflect
the probable intent of Congress.
Subsec. (a)(1). Pub. L. 100–607, § 713(i)(1)(B), substituted ‘‘1994’’ for ‘‘1991’’.
Subsec. (b). Pub. L. 100–607, § 713(i)(2), substituted
‘‘1994’’ for ‘‘1991’’ in two places.
1985—Subsecs. (a), (b). Pub. L. 99–92, § 8(f)(1), substituted ‘‘1991’’ for ‘‘1987’’ wherever appearing.
Subsec. (c). Pub. L. 99–92, § 8(f)(2), added subsec. (c).
1981—Pub. L. 97–35 substituted ‘‘1987’’ for ‘‘1983’’ wherever appearing.
1979—Subsec. (a). Pub. L. 96–76, § 109(c)(1), substituted
‘‘September 30, 1983, and not later than December 31,
1983’’ for ‘‘September 30, 1980, and not later than December 31, 1981’’. Prior to amendment, subsec. (a) referred to ‘‘December 31, 1980’’ rather than to ‘‘December
31, 1981’’ as cited in directory language of Pub. L. 96–76.
See below for explanation of amendment by Pub. L.
96–32.
Pub. L. 96–32 substituted ‘‘December 31, 1980’’ for
‘‘September 30, 1977’’.
Subsec. (a)(1). Pub. L. 96–76, § 109(c)(2), substituted
‘‘1983’’ for ‘‘1980’’.
Subsec. (b). Pub. L. 96–76, § 109(c)(3), substituted
‘‘1983’’ for ‘‘1980’’ wherever appearing.
1975—Subsec. (a). Pub. L. 94–63, §§ 936(d), 941(h)(2),
(i)(5), substituted ‘‘September 30, 1980’’ for ‘‘June 30,
1977’’ wherever appearing, struck out ‘‘of Health, Education, and Welfare’’ after ‘‘Secretary’’, and substituted references to section 835 of the Act for references to section 822, which had previously been translated as section 297a of this title, requiring no further
translations in text as a result of renumbering of the
Public Health Service Act.
Subsec. (b). Pub. L. 94–63, §§ 936(d), 941(h)(1), (4)(B),
substituted ‘‘subpart’’ for ‘‘part’’, ‘‘September 30, 1980’’
for ‘‘June 30, 1977’’, and ‘‘December 31, 1980’’ for ‘‘September 30, 1977’’ and struck out provisions relating to
payments from revolving fund established by section
297f(d) of this title.
1971—Pub. L. 92–158 substituted ‘‘1977’’ for ‘‘1975’’
wherever appearing.
Pub. L. 92–52 substituted ‘‘1975’’ for ‘‘1974’’ wherever
appearing.
1968—Pub. L. 90–490 substituted ‘‘1974’’ for ‘‘1972’’
wherever appearing.
1966—Subsec. (a). Pub. L. 89–751, § 6(d)(1), (2), substituted ‘‘an agreement pursuant to section 297a(b) of
this title’’ for ‘‘this part’’ in opening provisions, and in
par. (1) substituted ‘‘such balance’’ for ‘‘the balance’’.
Subsec. (b). Pub. L. 89–751, § 6(d)(3), inserted ‘‘(other
than so much of such fund as relates to payments from
the revolving fund established by section 297f(d) of this
title)’’.
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99–92 effective Oct. 1, 1985, see
section 10(a) of Pub. L. 99–92, set out as a note under
section 297a of this title.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by section 936(d) of Pub. L. 94–63 effective July 1, 1975, see section 905 of Pub. L. 94–63, set out
as a note under section 297a of this title.
Amendment by section 941(h)(1), (2), (4)(B), (i)(1), (5)
of Pub. L. 94–63 effective July 1, 1975, see section 942 of
Pub. L. 94–63, set out as a note under section 297a of
this title.

§ 297g

except in the case of payments pursuant to commitments (made prior to Nov. 3, 1966) to make loans under
section 297f of this title as in effect prior to Nov. 3, 1966,
see section 6(e)(1) of Pub. L. 89–751, set out as a note
under section 297d of this title.

§ 297f. Repealed. Pub. L. 94–63, title
§ 936(e)(1), July 29, 1975, 89 Stat. 363

IX,

Section, act July 1, 1944, ch. 373, title VIII, § 827, as
added Sept. 4, 1964, Pub. L. 88–581, § 2, 78 Stat. 917;
amended Nov. 3, 1966, Pub. L. 89–751, § 6(a), 80 Stat. 1233;
Aug. 16, 1968, Pub. L. 90–490, title II, § 222(g), 82 Stat. 785;
July 9, 1971, Pub. L. 92–52, § 3(c), 85 Stat. 145; Nov. 18,
1971, Pub. L. 92–158, § 6(d)(2), 85 Stat. 478, set out provisions relating to terms, conditions, limitations, manner of payment, etc., of loans to schools of nursing to
capitalize student loan funds.
EFFECTIVE DATE OF REPEAL
Repeal effective July 1, 1975, see section 905 of Pub. L.
94–63, set out as an Effective Date of 1975 Amendment
note under section 297a of this title.
AVAILABILITY OF NURSE TRAINING REVOLVING FUND
FOR PAYMENT OF OBLIGATIONS DEPOSITS INTO FUND;
TRANSFER OF EXCESS AMOUNTS TO GENERAL FUND
OF TREASURY AUTHORIZATION OF APPROPRIATIONS
Section 936(e)(2), (3) of Pub. L. 94–63 provided that:
‘‘(2) The nurse training fund created within the
Treasury by section 827(d)(1) of the Act [section
297f(d)(1) of this title] shall remain available to the
Secretary of Health, Education, and Welfare [now
Health and Human Services] for the purpose of meeting
his responsibilities respecting participations in obligations acquired under section 827 of the Act [this section]. The Secretary shall continue to deposit in such
fund all amounts received by him as interest payments
or repayments of principal on loans under such section
27[827]. If at any time the Secretary determines the
moneys in the funds exceed the present and any reasonable prospective further requirements of such fund,
such excess may be transferred to the general fund of
the Treasury.
‘‘(3) There are authorized to be appropriated without
fiscal year limitation such sums as may be necessary to
enable the Secretary to make payments under agreements entered into under section 827(b) of the Act [section 297f(b) of this title] before the date of the enactment of this Act [July 29, 1975].’’
CONVERSION OF FEDERAL CAPITAL CONTRIBUTION TO A
LOAN UNDER SECTION 297f OF THIS TITLE
Pub. L. 89–751, § 6(e)(2), Nov. 3, 1966, 80 Stat. 1236, authorized the Secretary of Health, Education, and Welfare to convert a Federal capital contribution to a student loan fund of a particular institution, made under
this subchapter, from funds appropriated pursuant
thereto for the fiscal year ending June 30, 1967, to a
loan under section 297f of this title.

§ 297g. Modification of agreements; compromise,
waiver or release
The Secretary may agree to modifications of
agreements made under this part, and may compromise, waive, or release any right, title,
claim, or demand of the United States arising or
acquired under this part.
(July 1, 1944, ch. 373, title VIII, § 840, formerly
§ 828, as added Pub. L. 88–581, § 2, Sept. 4, 1964, 78
Stat. 917; renumbered § 840 and amended Pub. L.
94–63, title IX, § 941(h)(1), (4)(C), (i)(1), July 29,
1975, 89 Stat. 365; Pub. L. 111–148, title V,
§ 5310(b)(2), Mar. 23, 2010, 124 Stat. 631.)

EFFECTIVE DATE OF 1966 AMENDMENT

AMENDMENTS

Amendment by Pub. L. 89–751 effective in the case of
payments to student loan funds made after Nov. 3, 1966,

2010—Pub. L. 111–148 substituted ‘‘this part’’ for ‘‘this
subpart’’ in two places.

§ 297h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1975—Pub. L. 94–63, § 941(h)(1), (4)(C), substituted ‘‘subpart’’ for ‘‘part’’ in two places and struck out ‘‘or
loans’’ after ‘‘agreements’’.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by Pub. L. 94–63 effective July 1, 1975, see
section 942 of Pub. L. 94–63, set out as a note under section 297a of this title.

§ 297h. Repealed. Pub. L. 99–92, § 9(a)(1), Aug. 16,
1985, 99 Stat. 400
Section, act July 1, 1944, ch. 373, title VIII, § 841, formerly § 829, as added Aug. 16, 1968, Pub. L. 90–490, title
II, § 222(h), 82 Stat. 785; renumbered § 841 and amended
July 29, 1975, Pub. L. 94–63, title IX, § 941(i)(1), (6), 89
Stat. 365, 366, related to transfers to the scholarship
program.

Page 856

A prior section 845 of act July 1, 1944, was renumbered
section 855, and was classified to section 298b–2 of this
title prior to repeal by Pub. L. 105–392.
A prior section 297k, act July 1, 1944, ch. 373, title
VIII, § 846, formerly § 861, as added Aug. 16, 1968, Pub. L.
90–490, title II, § 223(a), 82 Stat. 786; renumbered § 846 and
amended July 29, 1975, Pub. L. 94–63, title IX, §§ 941(j)(1),
(3), 89 Stat. 366, related to transfers of funds to student
loan program, prior to repeal by Pub. L. 97–35, title
XXVII, § 2758(c), Aug. 13, 1981, 95 Stat. 932.
AMENDMENTS
2010—Pub. L. 111–148 substituted ‘‘this part’’ for ‘‘this
subpart’’.
EFFECTIVE DATE

EFFECTIVE DATE OF REPEAL

Section effective Oct. 1, 1985, see section 10(a) of Pub.
L. 99–92, set out as an Effective Date of 1985 Amendment note under section 297a of this title.

Repeal effective Oct. 1, 1985, see section 10(a) of Pub.
L. 99–92, set out as an Effective Date of 1985 Amendment note under section 297a of this title.

§ 297n. Loan repayment and scholarship programs

§ 297i. Procedures for appeal of terminations
In any case in which the Secretary intends to
terminate an agreement with a school of nursing under this part, the Secretary shall provide
the school with a written notice specifying such
intention and stating that the school may request a formal hearing with respect to such termination. If the school requests such a hearing
within 30 days after the receipt of such notice,
the Secretary shall provide such school with a
hearing conducted by an administrative law
judge.
(July 1, 1944, ch. 373, title VIII, § 842, as added
Pub. L. 99–92, § 8(g), Aug. 16, 1985, 99 Stat. 399;
amended Pub. L. 111–148, title V, § 5310(b)(2),
Mar. 23, 2010, 124 Stat. 631.)
PRIOR PROVISIONS
A prior section 297i, act July 1, 1944, ch. 373, title
VIII, § 830, as added Nov. 18, 1971, Pub. L. 92–158, § 6(b)(2),
85 Stat. 477, relating to loan forgiveness, was transferred to and redesignated as subsec. (j) of section 823
of act July 1, 1944, which is classified to section 297b of
this title, by Pub. L. 94–63, title IX, § 941(h)(5), July 29,
1975, 89 Stat. 365.
A prior section 842 of act July 1, 1944, was renumbered
section 852, and was classified to section 298a of this
title prior to repeal by Pub. L. 105–392.
A prior section 297j, act July 1, 1944, ch. 373, title
VIII, § 843, as added Nov. 4, 1988, Pub. L. 100–607, title
VII, § 715, 102 Stat. 3162; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2616(a), 102 Stat. 4240; Aug. 16, 1989,
Pub. L. 101–93, § 5(s), 103 Stat. 614, provided grant authority for scholarships for undergraduate education of
professional nurses, prior to repeal by Pub. L. 102–531,
title III, § 313(a)(11), (c), Oct. 27, 1992, 106 Stat. 3507, effective immediately after enactment of Pub. L. 102–408,
approved Oct. 13, 1992.
A prior section 843 of act July 1, 1944, was renumbered
section 853, and was classified to section 298b of this
title prior to repeal by Pub. L. 105–392.
Another prior section 297j, act July 1, 1944, ch. 373,
title VIII, § 845, formerly § 860, as added Aug. 16, 1968,
Pub. L. 90–490, title II, § 223(a), 82 Stat. 785; amended
July 9, 1971, Pub. L. 92–52, § 4, 85 Stat. 145; Nov. 18, 1971,
Pub. L. 92–158, § 7, 85 Stat. 478; renumbered § 845 and
amended July 29, 1975, Pub. L. 94–63, title IX, §§ 902(f),
937, 941(j)(1), (2), 89 Stat. 355, 363, 366; Sept. 29, 1979, Pub.
L. 96–76, title I, § 110(a), (b), 93 Stat. 580; Aug. 13, 1981,
Pub. L. 97–35, title XXVII, § 2758(a), (b), 95 Stat. 932, set
forth provisions relating to scholarship grants to
schools of nursing, prior to repeal by Pub. L. 99–92,
§ 9(a)(2), Aug. 16, 1985, 99 Stat. 400, eff. Oct. 1, 1985.

(a) In general
In the case of any individual—
(1) who has received a baccalaureate or associate degree in nursing (or an equivalent degree), a diploma in nursing, or a graduate degree in nursing;
(2) who obtained (A) one or more loans from
a loan fund established under subpart II,1 or
(B) any other educational loan for nurse training costs; and
(3) who enters into an agreement with the
Secretary to serve as nurse for a period of not
less than two years at a health care facility
with a critical shortage of nurses, or in a 2 accredited school of nursing, as defined by section 296(2) of this title, as nurse faculty;
the Secretary shall make payments in accordance with subsection (b) of this section, for and
on behalf of that individual, on the principal of
and interest on any loan of that individual described in paragraph (2) of this subsection which
is outstanding on the date the individual begins
the service specified in the agreement described
in paragraph (3) of this subsection. After fiscal
year 2007, the Secretary may not, pursuant to
any agreement entered into under this subsection, assign a nurse to any private entity unless that entity is nonprofit.
(b) Manner of payments
The payments described in subsection (a) of
this section shall be made by the Secretary as
follows:
(1) Upon completion by the individual for
whom the payments are to be made of the first
year of the service specified in the agreement
entered into with the Secretary under subsection (a) of this section, the Secretary shall
pay 30 percent of the principal of, and the interest on each loan of such individual described in subsection (a)(2) of this section
which is outstanding on the date he began
such practice.
(2) Upon completion by that individual of
the second year of such service, the Secretary
shall pay another 30 percent of the principal
of, and the interest on each such loan.
1 See
2 So

References in Text note below.
in original. Probably should be ‘‘an’’.

Page 857

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Upon completion by that individual of a
third year of such service, the Secretary shall
pay another 25 percent of the principal of, and
the interest on each such loan.
(c) Payment by due date
Notwithstanding the requirement of completion of practice specified in subsection (b) of this
section, the Secretary shall, on or before the due
date thereof, pay any loan or loan installment
which may fall due within the period of service
for which the borrower may receive payments
under this subsection, upon the declaration of
such borrower, at such times and in such manner as the Secretary may prescribe (and supported by such other evidence as the Secretary
may reasonably require), that the borrower is
then serving as described by subsection (a)(3) of
this section, and that the borrower will continue
to so serve for the period required (in the absence of this subsection) to entitle the borrower
to have made the payments provided by this
subsection for such period; except that not more
than 85 percent of the principal of any such loan
shall be paid pursuant to this subsection.
(d) Scholarship program
(1) In general
The Secretary shall (for fiscal years 2003 and
2004) and may (for fiscal years thereafter)
carry out a program of entering into contracts
with eligible individuals under which such individuals agree to serve as nurses for a period
of not less than 2 years at a health care facility with a critical shortage of nurses, in consideration of the Federal Government agreeing
to provide to the individuals scholarships for
attendance at schools of nursing.
(2) Eligible individuals
In this subsection, the term ‘‘eligible individual’’ means an individual who is enrolled or
accepted for enrollment as a full-time or parttime student in a school of nursing.
(3) Service requirement
(A) In general
The Secretary may not enter into a contract with an eligible individual under this
subsection unless the individual agrees to
serve as a nurse at a health care facility
with a critical shortage of nurses for a period of full-time service of not less than 2
years, or for a period of part-time service in
accordance with subparagraph (B).
(B) Part-time service
An individual may complete the period of
service described in subparagraph (A) on a
part-time basis if the individual has a written agreement that—
(i) is entered into by the facility and the
individual and is approved by the Secretary; and
(ii) provides that the period of obligated
service will be extended so that the aggregate amount of service performed will
equal the amount of service that would be
performed through a period of full-time
service of not less than 2 years.
(4) Applicability of certain provisions
The provisions of subpart III of part D of
subchapter II of this chapter shall, except as

§ 297n

inconsistent with this section, apply to the
program established in paragraph (1) in the
same manner and to the same extent as such
provisions apply to the National Health Service Corps Scholarship Program established in
such subpart.
(e) Preferences regarding participants
In entering into agreements under subsection
(a) or (d) of this section, the Secretary shall give
preference to qualified applicants with the
greatest financial need.
(f) Condition of agreement
The Secretary may make payments under subsection (a) of this section on behalf of an individual only if the agreement under such subsection provides that section 298b–7(c) 1 of this
title is applicable to the individual.
(g) Breach of agreement
(1) In general
In the case of any program under this section under which an individual makes an
agreement to provide health services for a period of time in accordance with such program
in consideration of receiving an award of Federal funds regarding education as a nurse (including an award for the repayment of loans),
the following applies if the agreement provides
that this subsection is applicable:
(A) In the case of a program under this section that makes an award of Federal funds
for attending an accredited program of nursing (in this section referred to as a ‘‘nursing
program’’), the individual is liable to the
Federal Government for the amount of such
award (including amounts provided for expenses related to such attendance), and for
interest on such amount at the maximum
legal prevailing rate, if the individual—
(i) fails to maintain an acceptable level
of academic standing in the nursing program (as indicated by the program in accordance with requirements established by
the Secretary);
(ii) is dismissed from the nursing program for disciplinary reasons; or
(iii) voluntarily terminates the nursing
program.
(B) The individual is liable to the Federal
Government for the amount of such award
(including amounts provided for expenses related to such attendance), and for interest
on such amount at the maximum legal prevailing rate, if the individual fails to provide
health services in accordance with the program under this section for the period of
time applicable under the program.
(2) Waiver or suspension of liability
In the case of an individual or health facility
making an agreement for purposes of paragraph (1), the Secretary shall provide for the
waiver or suspension of liability under such
subsection if compliance by the individual or
the health facility, as the case may be, with
the agreements involved is impossible, or
would involve extreme hardship to the individual or facility, and if enforcement of the
agreements with respect to the individual or
facility would be unconscionable.

§ 297n

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Date certain for recovery
Subject to paragraph (2), any amount that
the Federal Government is entitled to recover
under paragraph (1) shall be paid to the United
States not later than the expiration of the 3year period beginning on the date the United
States becomes so entitled.
(4) Availability
Amounts recovered under paragraph (1) with
respect to a program under this section shall
be available for the purposes of such program,
and shall remain available for such purposes
until expended.
(h) Reports
Not later than 18 months after August 1, 2002,
and annually thereafter, the Secretary shall prepare and submit to the Congress a report describing the programs carried out under this
section, including statements regarding—
(1) the number of enrollees, scholarships,
loan repayments, and grant recipients;
(2) the number of graduates;
(3) the amount of scholarship payments and
loan repayments made;
(4) which educational institution the recipients attended;
(5) the number and placement location of the
scholarship and loan repayment recipients at
health care facilities with a critical shortage
of nurses;
(6) the default rate and actions required;
(7) the amount of outstanding default funds
of both the scholarship and loan repayment
programs;
(8) to the extent that it can be determined,
the reason for the default;
(9) the demographics of the individuals participating in the scholarship and loan repayment programs;
(10) justification for the allocation of funds
between the scholarship and loan repayment
programs; and
(11) an evaluation of the overall costs and
benefits of the programs.
(i) Funding
(1) Authorization of appropriations
For the purpose of payments under agreements entered into under subsection (a) or (d)
of this section, there are authorized to be appropriated such sums as may be necessary for
each of fiscal years 2003 through 2007.
(2) Allocations
Of the amounts appropriated under paragraph (1), the Secretary may, as determined
appropriate by the Secretary, allocate
amounts between the program under subsection (a) of this section and the program
under subsection (d) of this section.
(July 1, 1944, ch. 373, title VIII, § 846, as added
Pub. L. 102–408, title II, § 211(a)(3), Oct. 13, 1992,
106 Stat. 2078; amended Pub. L. 105–392, title I,
§ 133(d), Nov. 13, 1998, 112 Stat. 3576; Pub. L.
107–205, title I, § 103, Aug. 1, 2002, 116 Stat. 813;
Pub. L. 111–148, title V, § 5310(a), Mar. 23, 2010, 124
Stat. 631.)
REFERENCES IN TEXT
Subpart II, referred to in subsec. (a)(2), probably
should be ‘‘this part’’ to reflect the redesignation of

Page 858

subpart II of former part B of this subchapter as part
E of this subchapter by Pub. L. 105–392, title I, § 123(2),
Nov. 13, 1998, 112 Stat. 3562.
Section 298b–7(c) of this title, referred to in subsec.
(f), was repealed by Pub. L. 105–392, title I, § 123(1), Nov.
13, 1998, 112 Stat. 3562.
PRIOR PROVISIONS
A prior section 297n, act July 1, 1944, ch. 373, title
VIII, § 847, as added Nov. 4, 1988, Pub. L. 100–607, title
VII, § 716, 102 Stat. 3163; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2616(b), 102 Stat. 4240, established a
demonstration program for student loans with respect
to service in certain health care facilities in underserved areas, prior to repeal by Pub. L. 102–408, title II,
§ 210, Oct. 13, 1992, 106 Stat. 2078.
A prior section 846 of act July 1, 1944, was classified
to section 297k of this title and was repealed by Pub. L.
97–35.
AMENDMENTS
2010—Subsec. (a)(3). Pub. L. 111–148 inserted ‘‘, or in a
accredited school of nursing, as defined by section
296(2) of this title, as nurse faculty’’ before semicolon
at end.
2002—Pub. L. 107–205, § 103(b)(1), substituted ‘‘Loan repayment and scholarship programs’’ for ‘‘Loan repayment program’’ in section catchline.
Subsec. (a). Pub. L. 107–205, § 103(a)(2), inserted at end
of concluding provisions ‘‘After fiscal year 2007, the
Secretary may not, pursuant to any agreement entered
into under this subsection, assign a nurse to any private entity unless that entity is nonprofit.’’
Subsec. (a)(3). Pub. L. 107–205, § 103(a)(1), substituted
‘‘at a health care facility with a critical shortage of
nurses’’ for ‘‘in an Indian Health Service health center,
in a Native Hawaiian health center, in a public hospital, in a migrant health center, in a community
health center, in a rural health clinic, or in a public or
nonprofit private health facility determined by the
Secretary to have a critical shortage of nurses’’.
Subsec. (d). Pub. L. 107–205, § 103(b)(4), added subsec.
(d). Former subsec. (d) redesignated (f).
Subsec. (e). Pub. L. 107–205, § 103(c), substituted
‘‘under subsection (a) or (d) of this section, the Secretary shall give preference to qualified applicants with
the greatest financial need.’’ for ‘‘under subsection (a)
of this section, the Secretary shall give preference—
‘‘(1) to qualified applicants with the greatest financial need; and
‘‘(2) to qualified applicants that, with respect to
health facilities described in such subsection, agree
to serve in such health facilities located in geographic areas with a shortage of and need for nurses,
as determined by the Secretary.’’
Subsec. (f). Pub. L. 107–205, § 103(b)(2), (3), redesignated subsec. (d) as (f) and transferred it to appear
after subsec. (e). Former subsec. (f) redesignated (h).
Subsec. (g). Pub. L. 107–205, § 103(b)(2), (3), redesignated subsec. (h) as (g) and transferred it to appear
after subsec. (f). Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 107–205, § 103(b)(2), (d), redesignated subsec. (f) as (h) and amended it generally. Prior
to amendment, text of subsec. read as follows: ‘‘For
purposes of this section:
‘‘(1) The term ‘community health center’ has the
meaning given such term in section 254c(a) of this
title.
‘‘(2) The term ‘migrant health center’ has the
meaning given such term in section 254b(a)(1) of this
title.
‘‘(3) The term ‘rural health clinic’ has the meaning
given such term in section 1395x(aa)(2) of this title.’’
Former subsec. (h) redesignated (g).
Subsec. (i). Pub. L. 107–205, § 103(b)(2), (e), redesignated subsec. (g) as (i) and amended it generally. Prior
to amendment, text of subsec. read as follows: ‘‘For the
purpose of payments under agreements entered into
under subsection (a) of this section, there are author-

Page 859

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ized to be appropriated $5,000,000 for fiscal year 1993,
and $6,000,000 for fiscal year 1994.’’
1998—Subsec. (h). Pub. L. 105–392 added subsec. (h).
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.

§ 297n–1. Nurse faculty loan program
(a) School of nursing student loan fund
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may enter into an agreement with
any accredited school of nursing for the establishment and operation of a student loan fund in
accordance with this section, to increase the
number of qualified nursing faculty.
(b) Agreements
Each agreement entered into under subsection
(a) of this section shall—
(1) provide for the establishment of a student loan fund by the school involved;
(2) provide for deposit in the fund of—
(A) the Federal capital contributions to
the fund;
(B) an amount equal to not less than oneninth of such Federal capital contributions,
contributed by such school;
(C) collections of principal and interest on
loans made from the fund; and
(D) any other earnings of the fund;
(3) provide that the fund will be used only
for loans to students of the school in accordance with subsection (c) of this section and for
costs of collection of such loans and interest
thereon;
(4) provide that loans may be made from
such fund only to students pursuing a fulltime course of study or, at the discretion of
the Secretary, a part-time course of study in
an advanced degree program described in section 296j(b) of this title; and
(5) contain such other provisions as are necessary to protect the financial interests of the
United States.
(c) Loan provisions
Loans from any student loan fund established
by a school pursuant to an agreement under subsection (a) of this section shall be made to an individual on such terms and conditions as the
school may determine, except that—
(1) such terms and conditions are subject to
any conditions, limitations, and requirements
prescribed by the Secretary;
(2) in the case of any individual, the total of
the loans for any academic year made by
schools of nursing from loan funds established
pursuant to agreements under subsection (a)
of this section may not exceed $35,500,1 during
fiscal years 2010 and 2011 fiscal years 2 (after
fiscal year 2011, such amounts shall be adjusted to provide for a cost-of-attendance in1 So
2 So

in original. The comma probably should not appear.
in original.

§ 297n–1

crease for the yearly loan rate and the aggregate loan; 3
(3) an amount up to 85 percent of any such
loan (plus interest thereon) shall be canceled
by the school as follows:
(A) upon completion by the individual of
each of the first, second, and third year of
full-time employment, required by the loan
agreement entered into under this subsection, as a faculty member in an accredited a 4 school of nursing, the school shall
cancel 20 percent of the principle 5 of, and
the interest on, the amount of such loan unpaid on the first day of such employment;
and
(B) upon completion by the individual of
the fourth year of full-time employment, required by the loan agreement entered into
under this subsection, as a faculty member
in a school of nursing, the school shall cancel 25 percent of the principle 5 of, and the
interest on, the amount of such loan unpaid
on the first day of such employment;
(4) such a loan may be used to pay the cost
of tuition, fees, books, laboratory expenses,
and other reasonable education expenses;
(5) such a loan shall be repayable in equal or
graduated periodic installments (with the
right of the borrower to accelerate repayment)
over the 10-year period that begins 9 months
after the individual ceases to pursue a course
of study at a school of nursing; and
(6) such a loan shall—
(A) beginning on the date that is 3 months
after the individual ceases to pursue a
course of study at a school of nursing, bear
interest on the unpaid balance of the loan at
the rate of 3 percent per annum; or
(B) subject to subsection (e) of this section, if the school of nursing determines that
the individual will not complete such course
of study or serve as a faculty member as required under the loan agreement under this
subsection, bear interest on the unpaid balance of the loan at the prevailing market
rate.
(d) Payment of proportionate share
Where all or any part of a loan, or interest, is
canceled under this section, the Secretary shall
pay to the school an amount equal to the
school’s proportionate share of the canceled portion, as determined by the Secretary.
(e) Review by Secretary
At the request of the individual involved, the
Secretary may review any determination by an
accredited school of nursing under subsection
(c)(6)(B) of this section.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title VIII, § 846A, as added
Pub. L. 107–205, title II, § 203, Aug. 1, 2002, 116
3 So in original. A closing parenthesis probably should appear
before the semicolon.
4 So in original. The word ‘‘a’’ probably should not appear.
5 So in original. Probably should be ‘‘principal’’.

§ 297o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 817; amended Pub. L. 111–148, title V,
§ 5311(a), Mar. 23, 2010, 124 Stat. 631.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5311(a)(1), substituted ‘‘School of nursing student loan fund’’ for ‘‘Establishment’’ in heading and inserted ‘‘accredited’’ before ‘‘school’’ in text.
Subsec. (c)(2). Pub. L. 111–148, § 5311(a)(2)(A), substituted ‘‘$35,500, during fiscal years 2010 and 2011 fiscal
years (after fiscal year 2011, such amounts shall be adjusted to provide for a cost-of-attendance increase for
the yearly loan rate and the aggregate loan;’’ for
‘‘$30,000, plus any amount determined by the Secretary
on an annual basis to reflect inflation;’’.
Subsec. (c)(3)(A). Pub. L. 111–148, § 5311(a)(2)(B), inserted ‘‘an accredited’’ before ‘‘a school of nursing’’.
Subsec. (e). Pub. L. 111–148, § 5311(a)(3), substituted
‘‘an accredited school’’ for ‘‘a school’’.
Subsec. (f). Pub. L. 111–148, § 5311(a)(4), substituted
‘‘2010 through 2014’’ for ‘‘2003 through 2007’’.

§ 297o. Eligible individual student loan repayment
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may enter into an agreement with
eligible individuals for the repayment of education loans, in accordance with this section, to
increase the number of qualified nursing faculty.
(b) Agreements
Each agreement entered into under this subsection shall require that the eligible individual
shall serve as a full-time member of the faculty
of an accredited school of nursing, for a total period, in the aggregate, of at least 4 years during
the 6-year period beginning on the later of—
(1) the date on which the individual receives
a master’s or doctorate nursing degree from an
accredited school of nursing; or
(2) the date on which the individual enters
into an agreement under this subsection.
(c) Agreement provisions
Agreements entered into pursuant to subsection (b) shall be entered into on such terms
and conditions as the Secretary may determine,
except that—
(1) not more than 10 months after the date
on which the 6-year period described under
subsection (b) begins, but in no case before the
individual starts as a full-time member of the
faculty of an accredited school of nursing 1 the
Secretary shall begin making payments, for
and on behalf of that individual, on the outstanding principal of, and interest on, any
loan of that individual obtained to pay for
such degree;
(2) for an individual who has completed a
master’s in nursing or equivalent degree in
nursing—
(A) payments may not exceed $10,000 per
calendar year; and
(B) total payments may not exceed $40,000
during the 2010 and 2011 fiscal years (after
fiscal year 2011, such amounts shall be adjusted to provide for a cost-of-attendance increase for the yearly loan rate and the aggregate loan); and

(3) for an individual who has completed a
doctorate or equivalent degree in nursing—
(A) payments may not exceed $20,000 per
calendar year; and
(B) total payments may not exceed $80,000
during the 2010 and 2011 fiscal years (adjusted for subsequent fiscal years as provided for in the same manner as in paragraph (2)(B)).
(d) Breach of agreement
(1) In general
In the case of any agreement made under
subsection (b), the individual is liable to the
Federal Government for the total amount paid
by the Secretary under such agreement, and
for interest on such amount at the maximum
legal prevailing rate, if the individual fails to
meet the agreement terms required under such
subsection.
(2) Waiver or suspension of liability
In the case of an individual making an
agreement for purposes of paragraph (1), the
Secretary shall provide for the waiver or suspension of liability under such paragraph if
compliance by the individual with the agreement involved is impossible or would involve
extreme hardship to the individual or if enforcement of the agreement with respect to
the individual would be unconscionable.
(3) Date certain for recovery
Subject to paragraph (2), any amount that
the Federal Government is entitled to recover
under paragraph (1) shall be paid to the United
States not later than the expiration of the 3year period beginning on the date the United
States becomes so entitled.
(4) Availability
Amounts recovered under paragraph (1) shall
be available to the Secretary for making loan
repayments under this section and shall remain available for such purpose until expended.
(e) Eligible individual defined
For purposes of this section, the term ‘‘eligible individual’’ means an individual who—
(1) is a United States citizen, national, or
lawful permanent resident;
(2) holds an unencumbered license as a registered nurse; and
(3) has either already completed a master’s
or doctorate nursing program at an accredited
school of nursing or is currently enrolled on a
full-time or part-time basis in such a program.
(f) Priority
For the purposes of this section and section
297n–1 of this title, funding priority will be
awarded to School of Nursing Student Loans 2
that support doctoral nursing students or Individual Student Loan Repayment 3 that support
doctoral nursing students.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.
2 So

in original. Probably should not be capitalized.
in original. Probably should be ‘‘individual student loan
repayments’’.
3 So

1 So

in original. Probably should be followed by a comma.

Page 860

Page 861

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title VIII, § 847, as added
Pub. L. 111–148, title V, § 5311(b), Mar. 23, 2010, 124
Stat. 632.)
PRIOR PROVISIONS
A prior section 847 of act July 1, 1944, was classified
to section 297n of this title prior to repeal by Pub. L.
102–408.
A prior section 297q, act July 1, 1944, ch. 373, title
VIII, § 841, as added Pub. L. 105–392, title I, § 123(5), Nov.
13, 1998, 112 Stat. 3569, was renumbered section 871 of
act July 1, 1944, and amended by Pub. L. 111–148, title
V, §§ 5310(b)(7), 5312, Mar. 23, 2010, 124 Stat. 631, 633, and
transferred to section 298d of this title.

PART F—NATIONAL ADVISORY COUNCIL ON
NURSE EDUCATION AND PRACTICE
PRIOR PROVISIONS
A prior part F, consisting of section 297q, was redesignated part I (§ 298d) of this subchapter.
AMENDMENTS
2010—Pub. L. 111–148, title V, § 5310(b)(8)(B), Mar. 23,
2010, 124 Stat. 631, redesignated part G ‘‘National Advisory Council on Nurse Education and Practice’’ as F.

§ 297t. National Advisory Council on Nurse Education and Practice
(a) Establishment
The Secretary shall establish an advisory
council to be known as the National Advisory
Council on Nurse Education and Practice (in
this section referred to as the ‘‘Advisory Council’’).
(b) Composition
(1) In general
The Advisory Council shall be composed of—
(A) not less than 21, nor more than 23 individuals, who are not officers or employees of
the Federal Government, appointed by the
Secretary without regard to the Federal
civil service laws, of which—
(i) 2 shall be selected from full-time students enrolled in schools of nursing;
(ii) 2 shall be selected from the general
public;
(iii) 2 shall be selected from practicing
professional nurses; and
(iv) 9 shall be selected from among the
leading authorities in the various fields of
nursing, higher, secondary education, and
associate degree schools of nursing, and
from representatives of advanced education nursing groups (such as nurse practitioners, nurse midwives, and nurse anesthetists), hospitals, and other institutions
and organizations which provide nursing
services; and
(B) the Secretary (or the delegate of the
Secretary (who shall be an ex officio member
and shall serve as the Chairperson)).
(2) Appointment
Not later than 90 days after November 13,
1998, the Secretary shall appoint the members
of the Advisory Council and each such member
shall serve a 4 year term. In making such appointments, the Secretary shall ensure a fair
balance between the nursing professions, a
broad geographic representation of members

§ 297t

and a balance between urban and rural members. Members shall be appointed based on
their competence, interest, and knowledge of
the mission of the profession involved. A majority of the members shall be nurses.
(3) Minority representation
In appointing the members of the Advisory
Council under paragraph (1), the Secretary
shall ensure the adequate representation of
minorities.
(c) Vacancies
(1) In general
A vacancy on the Advisory Council shall be
filled in the manner in which the original appointment was made and shall be subject to
any conditions which applied with respect to
the original appointment.
(2) Filling unexpired term
An individual chosen to fill a vacancy shall
be appointed for the unexpired term of the
member replaced.
(d) Duties
The Advisory Council shall—
(1) provide advice and recommendations to
the Secretary and Congress concerning policy
matters arising in the administration of this
subchapter, including the range of issues relating to the nurse workforce, education, and
practice improvement;
(2) provide advice to the Secretary and Congress in the preparation of general regulations
and with respect to policy matters arising in
the administration of this subchapter, including the range of issues relating to nurse supply, education and practice improvement; and
(3) not later than 3 years after November 13,
1998, and annually thereafter, prepare and submit to the Secretary, the Committee on Labor
and Human Resources of the Senate, and the
Committee on Commerce of the House of Representatives, a report describing the activities
of the Council, including findings and recommendations made by the Council concerning
the activities under this subchapter.
(e) Meetings and documents
(1) Meetings
The Advisory Council shall meet not less
than 2 times each year. Such meetings shall be
held jointly with other related entities established under this subchapter where appropriate.
(2) Documents
Not later than 14 days prior to the convening
of a meeting under paragraph (1), the Advisory
Council shall prepare and make available an
agenda of the matters to be considered by the
Advisory Council at such meeting. At any
such meeting, the Advisory Council shall distribute materials with respect to the issues to
be addressed at the meeting. Not later than 30
days after the adjourning of such a meeting,
the Advisory Council shall prepare and make
available a summary of the meeting and any
actions taken by the Council based upon the
meeting.

§ 297w

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Compensation and expenses
(1) Compensation
Each member of the Advisory Council shall
be compensated at a rate equal to the daily
equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule
under section 5315 of title 5 for each day (including travel time) during which such member is engaged in the performance of the duties
of the Council. All members of the Council
who are officers or employees of the United
States shall serve without compensation in
addition to that received for their services as
officers or employees of the United States.
(2) Expenses
The members of the Advisory Council shall
be allowed travel expenses, including per diem
in lieu of subsistence, at rates authorized for
employees of agencies under subchapter I of
chapter 57 of title 5 while away from their
homes or regular places of business in the performance of services for the Council.
(g) Funding
Amounts appropriated under this subchapter
may be utilized by the Secretary to support the
nurse education and practice activities of the
Council.
(h) FACA
The Federal Advisory Committee Act shall
apply to the Advisory Committee under this section only to the extent that the provisions of
such Act do not conflict with the requirements
of this section.
(July 1, 1944, ch. 373, title VIII, § 851, formerly
§ 845, as added Pub. L. 105–392, title I, § 123(5),
Nov. 13, 1998, 112 Stat. 3572; renumbered § 851,
Pub. L. 111–148, title V, § 5310(b)(8)(A), Mar. 23,
2010, 124 Stat. 631.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (h), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5,
Government Organization and Employees.
CODIFICATION
November 13, 1998, referred to in subsec. (b)(2), was in
the original ‘‘the date of enactment of this Act’’, which
was translated as meaning the date of enactment of
Pub. L. 105–392, which enacted this part, to reflect the
probable intent of Congress.
PRIOR PROVISIONS
A prior section 851 of act July 1, 1944, was renumbered
section 861 and is classified to section 297w of this title.
Another prior section 851 of act July 1, 1944, was classified to section 298 of this title, prior to repeal by Pub.
L. 105–392.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.

Page 862

TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

PART G—PUBLIC SERVICE ANNOUNCEMENTS
PRIOR PROVISIONS
A prior part G, consisting of section 297t, was redesignated part F of this subchapter.
AMENDMENTS
2010—Pub. L. 111–148, title V, § 5310(b)(9)(B), Mar. 23,
2010, 124 Stat. 631, redesignated part H ‘‘Public Service
Announcements’’ as G.

§ 297w. Public service announcements
(a) In general
The Secretary shall develop and issue public
service announcements that advertise and promote the nursing profession, highlight the advantages and rewards of nursing, and encourage
individuals to enter the nursing profession.
(b) Method
The public service announcements described in
subsection (a) of this section shall be broadcast
through appropriate media outlets, including
television or radio, in a manner intended to
reach as wide and diverse an audience as possible.
(c) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2003 through 2007.
(July 1, 1944, ch. 373, title VIII, § 861, formerly
§ 851, as added Pub. L. 107–205, title I, § 102, Aug.
1, 2002, 116 Stat. 812; renumbered § 861, Pub. L.
111–148, title V, § 5310(b)(9)(A), Mar. 23, 2010, 124
Stat. 631.)
PRIOR PROVISIONS
A prior section 861 of act July 1, 1944, was classified
to section 298c of this title, prior to the reorganization
and amendment of this subchapter by Pub. L. 90–490.
Another prior section 861 of act July 1, 1944, was classified to section 298c–1 of this title, prior to renumbering as section 846 by Pub. L. 94–63, transfer to section
297k of this title, and subsequent repeal.

§ 297x. State and local public service announcements
(a) In general
The Secretary may award grants to eligible
entities to support State and local advertising
campaigns through appropriate media outlets to
promote the nursing profession, highlight the
advantages and rewards of nursing, and encourage individuals from disadvantaged backgrounds
to enter the nursing profession.
(b) Use of funds
An eligible entity that receives a grant under
subsection (a) of this section shall use funds received through such grant to acquire local television and radio time, place advertisements in
local newspapers, or post information on billboards or on the Internet in a manner intended

Page 863

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to reach as wide and diverse an audience as possible, in order to—
(1) advertise and promote the nursing profession;
(2) promote nursing education programs;
(3) inform the public of financial assistance
regarding such education programs;
(4) highlight individuals in the community
who are practicing nursing in order to recruit
new nurses; or
(5) provide any other information to recruit
individuals for the nursing profession.
(c) Limitation
An eligible entity that receives a grant under
subsection (a) of this section shall not use funds
received through such grant to advertise particular employment opportunities.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2003 through 2007.
(July 1, 1944, ch. 373, title VIII, § 862, formerly
§ 852, as added Pub. L. 107–205, title I, § 102, Aug.
1, 2002, 116 Stat. 812; renumbered § 862, Pub. L.
111–148, title V, § 5310(b)(9)(A), Mar. 23, 2010, 124
Stat. 631.)
PRIOR PROVISIONS
A prior section 862 of act July 1, 1944, was classified
to section 298c–1 of this title, prior to the reorganization and amendment of this subchapter by Pub. L.
90–490.

PART H—COMPREHENSIVE GERIATRIC EDUCATION
PRIOR PROVISIONS
A prior part H, consisting of sections 297w and 297x,
was redesignated part G of this subchapter.
AMENDMENTS
2010—Pub. L. 111–148, title V, § 5310(b)(10)(B), Mar. 23,
2010, 124 Stat. 631, redesignated part I ‘‘Comprehensive
Geriatric Education’’ as H.

§ 298. Comprehensive geriatric education
(a) Program authorized
The Secretary shall award grants to eligible
entities to develop and implement, in coordination with programs under section 294c of this
title, programs and initiatives to train and educate individuals in providing geriatric care for
the elderly.
(b) Use of funds
An eligible entity that receives a grant under
subsection (a) of this section shall use funds
under such grant to—
(1) provide training to individuals who will
provide geriatric care for the elderly;
(2) develop and disseminate curricula relating to the treatment of the health problems of
elderly individuals;
(3) train faculty members in geriatrics;
(4) provide continuing education to individuals who provide geriatric care; or
(5) establish traineeships for individuals who
are preparing for advanced education nursing
degrees in geriatric nursing, long-term care,
gero-psychiatric nursing or other nursing
areas that specialize in the care of the elderly
population.

§ 298

(c) Application
An eligible entity desiring a grant under subsection (a) of this section shall submit an application to the Secretary at such time, in such
manner, and containing such information as the
Secretary may reasonably require.
(d) Eligible entity
For purposes of this section, the term ‘‘eligible entity’’ includes a school of nursing, a
health care facility, a program leading to certification as a certified nurse assistant, a partnership of such a school and facility, or a partnership of such a program and facility.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title VIII, § 865, formerly
§ 855, as added Pub. L. 107–205, title II, § 202(a),
Aug. 1, 2002, 116 Stat. 816; renumbered § 865 and
amended Pub. L. 111–148, title V, §§ 5305(c),
5310(b)(10)(A), Mar. 23, 2010, 124 Stat. 625, 631.)
PRIOR PROVISIONS
A prior section 298, act July 1, 1944, ch. 373, title VIII,
§ 851, formerly § 841, as added Pub. L. 88–581, § 2, Sept. 4,
1964, 78 Stat. 917; amended Pub. L. 89–751, § 3(b), Nov. 3,
1966, 80 Stat. 1230; Pub. L. 91–515, title VI, § 601(b)(2),
Oct. 30, 1970, 84 Stat. 1311; Pub. L. 92–158, §§ 9, 13, Nov.
18, 1971, 85 Stat. 479, 480; renumbered § 851 and amended
Pub. L. 94–63, title IX, § 941(k)(1), (2), July 29, 1975, 89
Stat. 366; Pub. L. 97–35, title XXVII, § 2759(a), Aug. 13,
1981, 95 Stat. 932; Pub. L. 99–92, § 9(d), Aug. 16, 1985, 99
Stat. 402; Pub. L. 100–607, title VII, § 721(a), Nov. 4, 1988,
102 Stat. 3165; Pub. L. 102–408, title II, § 212, Oct. 13, 1992,
106 Stat. 2079, related to Advisory Council on Nurse
Education and Practice, prior to repeal by Pub. L.
105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562. See
section 297t of this title.
A prior section 865 of act July 1, 1944, was classified
to section 298c–4 of this title, prior to the reorganization and amendment of this subchapter by Pub. L.
90–490.
Prior sections 298a to 298b–1 were repealed by Pub. L.
105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562.
Section 298a, act July 1, 1944, ch. 373, title VIII, § 852,
formerly § 842, as added Pub. L. 88–581, § 2, Sept. 4, 1964,
78 Stat. 918; renumbered § 852 and amended Pub. L.
94–63, title IX, § 941(k)(1), July 29, 1975, 89 Stat. 366, directed Federal noninterference with administration of
institutions.
Section 298b, act July 1, 1944, ch. 373, title VIII, § 853,
formerly § 843, as added Pub. L. 88–581, § 2, Sept. 4, 1964,
78 Stat. 918; amended Pub. L. 89–290, § 5(b), Oct. 22, 1965,
79 Stat. 1058; Pub. L. 90–490, title II, §§ 203, 204, 213, 231,
Aug. 16, 1968, 82 Stat. 780, 783, 787; Pub. L. 92–158,
§ 2(d)(1), (2), Nov. 18, 1971, 85 Stat. 467, 468; renumbered
§ 853 and amended Pub. L. 94–63, title IX, § 941(k)(1), (3),
July 29, 1975, 89 Stat. 366, 367; Pub. L. 96–32, § 7(k), July
10, 1979, 93 Stat. 84; Pub. L. 97–35, title XXVII, § 2759(b),
Aug. 13, 1981, 95 Stat. 932; Pub. L. 99–92, § 9(e), (f), Aug.
16, 1985, 99 Stat. 402; Pub. L. 102–408, title II, § 202(b),
Oct. 13, 1992, 106 Stat. 2071, defined terms.
Section 298b–1, act July 1, 1944, ch. 373, title VIII,
§ 854, formerly § 844, as added Pub. L. 92–158, § 10, Nov. 18,
1971, 85 Stat. 479; renumbered § 854, Pub. L. 94–63, title
IX, § 941(k)(1), July 29, 1975, 89 Stat. 366, authorized advance funding for grants, contracts, or other payments.
A prior section 298b–2, act July 1, 1944, ch. 373, title
VIII, § 855, formerly § 845, as added Pub. L. 92–158, § 11,
Nov. 18, 1971, 85 Stat. 479; renumbered § 855, Pub. L.
94–63, title IX, § 941(k)(1), July 29, 1975, 89 Stat. 366,
which prohibited discrimination by schools on basis of
sex, was renumbered section 810 of act July 1, 1944, by

§ 298d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 105–392 and transferred to section 296g of this
title.
Prior sections 298b–3 to 298b–5 were repealed by Pub.
L. 105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562.
Section 298b–3, act July 1, 1944, ch. 373, title VIII,
§ 856, as added Pub. L. 94–63, title IX, § 941(k)(4), July 29,
1975, 89 Stat. 367; amended Pub. L. 97–35, title XXVII,
§ 2759(c), Aug. 13, 1981, 95 Stat. 932; Pub. L. 100–607, title
VII, § 721(b)(2), Nov. 4, 1988, 102 Stat. 3165, related to
delegation of authority to administer programs.
Section 298b–4, act July 1, 1944, ch. 373, title VIII,
§ 857, as added Pub. L. 97–414, § 8(m), Jan. 4, 1983, 96 Stat.
2061, authorized use of funds to provide technical assistance.
Section 298b–5, act July 1, 1944, ch. 373, title VIII,
§ 858, formerly § 804, as added Pub. L. 88–581, § 2, Sept. 4,
1964, 78 Stat. 911; amended Pub. L. 92–158, §§ 2(d)(3), 13,
Nov. 18, 1971, 85 Stat. 468, 480; Pub. L. 94–63, title IX,
§ 941(c), July 29, 1975, 89 Stat. 364; renumbered § 858 and
amended Pub. L. 99–92, § 9(c)(1), Aug. 16, 1985, 99 Stat.
400; Pub. L. 99–129, title II, § 207(e)(1)–(3), Oct. 22, 1985, 99
Stat. 529, described conditions for United States recovery for construction assistance.
A prior section 298b–6, act July 1, 1944, ch. 373, title
VIII, § 859, as added Nov. 4, 1988, Pub. L. 100–607, title
VII, § 722, 102 Stat. 3165; amended Oct. 13, 1992, Pub. L.
102–408, title II, § 213, 106 Stat. 2080, directed Secretary
to provide for evaluations of projects carried out pursuant to this subchapter and submit reports to Congress
summarizing evaluations, and made one percent of
amount appropriated each fiscal year available to carry
out section, prior to repeal by Pub. L. 104–66, title I,
§ 1061(c), Dec. 21, 1995, 109 Stat. 719.
A prior section 298b–7, act July 1, 1944, ch. 373, title
VIII, § 860, as added Pub. L. 102–408, title II, § 209, Oct.
13, 1992, 106 Stat. 2075; amended Pub. L. 102–531, title III,
§ 313(a)(10), Oct. 27, 1992, 106 Stat. 3507; Pub. L. 103–43,
title XX, § 2014(g), June 10, 1993, 107 Stat. 217, set forth
certain generally applicable provisions, prior to repeal
by Pub. L. 105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat.
3562.
A prior section 298c, act July 1, 1944, ch. 373, title
VIII, § 860, as added Aug. 16, 1968, Pub. L. 90–490, title II,
§ 223(a), 82 Stat. 785; amended July 9, 1971, Pub. L. 92–52,
§ 4, 85 Stat. 145; Nov. 18, 1971, Pub. L. 92–158, § 7, 85 Stat.
478, which related to scholarship grants, was renumbered section 845 of act July 1, 1944, by Pub. L. 94–63 and
transferred to section 297j of this title and subsequently repealed.
Another prior section 298c, act July 1, 1944, ch. 373,
title VIII, § 861, as added Nov. 3, 1966, Pub. L. 89–751,
§ 8(b), 80 Stat. 1236, stated the purposes of opportunity
grants for nursing education and authorized appropriations of $3,000,000, $5,000,000, and $7,000,000 for fiscal
years ending June 30, 1967, 1968, and 1969, respectively,
to be available for payments to institutions until close
of fiscal year succeeding fiscal year for which appropriated, prior to the reorganization and amendment of
this subchapter by Pub. L. 90–490.
A prior section 298c–1, act July 1, 1944, ch. 373, title
VIII, § 861, as added Aug. 16, 1968, Pub. L. 90–490, title II,
§ 223(a), 82 Stat. 786, related to transfers to student loan
program, was renumbered section 846 of act July 1, 1944,
by Pub. L. 94–63 and transferred to section 297k of this
title and subsequently repealed.
Another prior section 298c–1, act July 1, 1944, ch. 373,
title VIII, § 862, as added Nov. 3, 1966, Pub. L. 89–751,
§ 8(b), 80 Stat. 1237, prescribed amount of nursing educational opportunity grant and provided for its annual
determination, prior to the reorganization and amendment of this subchapter by Pub. L. 90–490.
Sections 298c–2 to 298c–6 were omitted in the reorganization and amendment of this subchapter by Pub. L.
90–490, title II, § 223, Aug. 16, 1968, 82 Stat. 785.
Section 298c–2, act July 1, 1944, ch. 373, title VIII,
§ 863, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat.
1237, related to duration of a nursing educational opportunity grant.
Section 298c–3, act July 1, 1944, ch. 373, title VIII,
§ 864, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat.

Page 864

1238, related to selection of recipients of nursing educational opportunity grants.
Section 298c–4, act July 1, 1944, ch. 373, title VIII,
§ 865, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat.
1238, related to allotment of nursing educational opportunity grant funds among States.
Section 298c–5, act July 1, 1944, ch. 373, title VIII,
§ 866, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat.
1238, related to allocation of allotted funds to schools of
nursing.
Section 298c–6, act July 1, 1944, ch. 373, title VIII,
§ 867, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat.
1239, related to agreements with schools of nursing.
A prior section 298c–7, act July 1, 1944, ch. 373, title
VIII, § 868, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80
Stat. 1239; amended Nov. 18, 1971, Pub. L. 92–158, § 8, 85
Stat. 478; July 29, 1975, Pub. L. 94–63, title IX, § 902(g),
89 Stat. 355, authorized grants and contracts to encourage full utilization of educational talent for nursing
profession and authorized appropriations from fiscal
year ending June 30, 1972 through fiscal year ending
June 30, 1975 for implementation, prior to repeal by
Pub. L. 94–63, title IX, §§ 905, 931(b), July 29, 1975, 89
Stat. 355, 362, effective July 1, 1975.
A prior section 298c–8, act July 1, 1944, ch. 373, title
VIII, § 869, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80
Stat. 1240, defined ‘‘academic year’’, prior to repeal by
Pub. L. 94–63, title IX, §§ 941(j)(4), 942, July 29, 1975, 89
Stat. 366, 367, effective July 1, 1975.
AMENDMENTS
2010—Subsec. (b)(5). Pub. L. 111–148, § 5305(c)(1), added
par. (5).
Subsec. (e). Pub. L. 111–148, § 5305(c)(2), substituted
‘‘2010 through 2014’’ for ‘‘2003 through 2007’’.

PART I—FUNDING
PRIOR PROVISIONS
A prior part I, consisting of section 298, was redesignated part H of this subchapter.
AMENDMENTS
2010—Pub. L. 111–148, title V, § 5310(b)(7), Mar. 23, 2010,
124 Stat. 631, redesignated part F ‘‘Funding’’ as I.

§ 298d. Authorization of appropriations
For the purpose of carrying out parts B, C, and
D (subject to section 297t(g) of this title), there
are authorized to be appropriated $338,000,000 for
fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through
2016.
(July 1, 1944, ch. 373, title VIII, § 871, formerly
§ 841, as added Pub. L. 105–392, title I, § 123(5),
Nov. 13, 1998, 112 Stat. 3569; renumbered § 871 and
amended Pub. L. 111–148, title V, §§ 5310(b)(7),
5312, Mar. 23, 2010, 124 Stat. 631, 633.)
CODIFICATION
Section was classified to section 297q of this title
prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Pub. L. 111–148, § 5312, amended section generally. Prior to amendment, section related to authorization of appropriations for fiscal years 1998 through 2002,
allocations of amounts, and use of methodology.

SUBCHAPTER VII—AGENCY FOR
HEALTHCARE RESEARCH AND QUALITY
PRIOR PROVISIONS
A prior subchapter VII, related to the Agency for
Health Care Policy and Research and consisted of sections 299 to 299c–6, prior to the general amendment of

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this subchapter by Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1653.
Another prior subchapter VII, related to education,
research, training, and demonstrations in heart disease, cancer, stroke, and related diseases and consisted
of sections 299 to 299j, prior to repeal by Pub. L. 99–117,
§ 12(d), Oct. 7, 1985, 99 Stat. 495.

PART A—ESTABLISHMENT AND GENERAL DUTIES
§ 299. Mission and duties
(a) In general
There is established within the Public Health
Service an agency to be known as the Agency
for Healthcare Research and Quality, which
shall be headed by a director appointed by the
Secretary. The Secretary shall carry out this
subchapter acting through the Director.
(b) Mission
The purpose of the Agency is to enhance the
quality, appropriateness, and effectiveness of
health services, and access to such services,
through the establishment of a broad base of scientific research and through the promotion of
improvements in clinical and health system
practices, including the prevention of diseases
and other health conditions. The Agency shall
promote health care quality improvement by
conducting and supporting—
(1) research that develops and presents scientific evidence regarding all aspects of health
care, including—
(A) the development and assessment of
methods for enhancing patient participation
in their own care and for facilitating shared
patient-physician decision-making;
(B) the outcomes, effectiveness, and costeffectiveness of health care practices, including preventive measures and long-term
care;
(C) existing and innovative technologies;
(D) the costs and utilization of, and access
to health care;
(E) the ways in which health care services
are organized, delivered, and financed and
the interaction and impact of these factors
on the quality of patient care;
(F) methods for measuring quality and
strategies for improving quality; and
(G) ways in which patients, consumers,
purchasers, and practitioners acquire new
information about best practices and health
benefits, the determinants and impact of
their use of this information;
(2) the synthesis and dissemination of available scientific evidence for use by patients,
consumers, practitioners, providers, purchasers, policy makers, and educators; and
(3) initiatives to advance private and public
efforts to improve health care quality.
(c) Requirements with respect to rural and
inner-city areas and priority populations
(1) Research, evaluations and demonstration
projects
In carrying out this subchapter, the Director
shall conduct and support research and evaluations, and support demonstration projects,
with respect to—
(A) the delivery of health care in innercity areas, and in rural areas (including
frontier areas); and

§ 299

(B) health care for priority populations,
which shall include—
(i) low-income groups;
(ii) minority groups;
(iii) women;
(iv) children;
(v) the elderly; and
(vi) individuals with special health care
needs, including individuals with disabilities and individuals who need chronic care
or end-of-life health care.
(2) Process to ensure appropriate research
The Director shall establish a process to ensure that the requirements of paragraph (1)
are reflected in the overall portfolio of research conducted and supported by the Agency.
(3) Office of Priority Populations
The Director shall establish an Office of Priority Populations to assist in carrying out the
requirements of paragraph (1).
(July 1, 1944, ch. 373, title IX, § 901, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1653.)
PRIOR PROVISIONS
A prior section 299, act July 1, 1944, ch. 373, title IX,
§ 901, as added Pub. L. 101–239, title VI, § 6103(a), Dec. 19,
1989, 103 Stat. 2189; amended Pub. L. 102–410, § 2(a), Oct.
13, 1992, 106 Stat. 2094, established the Agency for
Health Care Policy and Research, prior to the general
amendment of this subchapter by Pub. L. 106–129.
Another prior section 299, act July 1, 1944, ch. 373,
title IX, § 900, as added Oct. 6, 1965, Pub. L. 89–239, § 2,
79 Stat. 926; amended Oct. 30, 1970, Pub. L. 91–515, title
I, § 102, 84 Stat. 1297, set forth Congressional declaration
of purpose of this subchapter to encourage and assist
regional cooperative arrangements among medical
schools, research institutions, and hospitals for research, training and medical data exchange, and to improve quality and capacity of health manpower and facilities available throughout the nation, prior to repeal
by Pub. L. 99–117, § 12(d), Oct. 7, 1985, 99 Stat. 495.
A prior section 901 of act July 1, 1944, was classified
to section 299a of this title prior to repeal by Pub. L.
99–117.
CONSTRUCTION
Pub. L. 106–129, § 2(b), Dec. 6, 1999, 113 Stat. 1670, provided that:
‘‘(1) IN GENERAL.—Section 901(a) of the Public Health
Service Act [subsec. (a) of this section] (as added by
subsection (a) of this section) applies as a redesignation
of the agency that carried out title IX of such Act [this
subchapter] on the day before the date of the enactment of this Act [Dec. 6, 1999], and not as the termination of such agency and the establishment of a different agency. The amendment made by subsection (a)
of this section [enacting this subchapter] does not affect appointments of the personnel of such agency who
were employed at the agency on the day before such
date, including the appointments of members of advisory councils or study sections of the agency who were
serving on the day before such date of enactment.
‘‘(2) REFERENCES.—Any reference in law to the Agency for Health Care Policy and Research is deemed to be
a reference to the Agency for Healthcare Research and
Quality, and any reference in law to the Administrator
for Health Care Policy and Research is deemed to be a
reference to the Director of the Agency for Healthcare
Research and Quality.’’
TRANSITIONAL AND SAVINGS PROVISIONS
Section 6103(f) of Pub. L. 101–239 provided that personnel of the Department of Health and Human Services

§ 299a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

employed, and Department assets used in connection
with Department functions, on Dec. 19, 1989, be transferred to the Administrator for Health Care Policy and
Research for appropriate allocation, and provided that
orders, rules, regulations, grants, contracts, certificates, licenses, privileges, and other determinations,
actions, or official documents would continue in effect
according to their terms unless changed pursuant to
law.
IOM REPORTS ON BEST PRACTICES FOR DEVELOPING
CLINICAL PROTOCOLS
Pub. L. 110–275, title III, § 304(b), July 15, 2008, 122
Stat. 2595, as amended by Pub. L. 111–148, title X,
§ 10303(c), Mar. 23, 2010, 124 Stat. 938, provided that:
‘‘(1) STUDY.—Not later than 60 days after the date of
the enactment of this Act [July 15, 2008], the Secretary
of Health and Human Services shall enter into a contract with the Institute of Medicine of the National
Academies (in this section [this note] referred to as the
‘Institute’) under which the Institute shall conduct a
study on the best methods used in developing clinical
practice guidelines in order to ensure that organizations developing such guidelines have information on
approaches that are objective, scientifically valid, and
consistent.
‘‘(2) REPORT.—Not later than 18 months after the effective date of the contract under paragraph (1), the Institute, as part of such contract, shall submit to the
Secretary of Health and Human Services and the appropriate committees of jurisdiction of Congress a report
containing the results of the study conducted under
paragraph (1), together with recommendations for such
legislation and administrative action as the Institute
determines appropriate.
‘‘(3) PARTICIPATION.—The contract under paragraph
(1) shall require that stakeholders with expertise in
making clinical recommendations participate on the
panel responsible for conducting the study under paragraph (1) and preparing the report under paragraph (2).
‘‘(4) IDENTIFICATION.—
‘‘(A) IN GENERAL.—Following receipt of the report
submitted under paragraph (2), and not less than
every 3 years thereafter, the Secretary shall contract
with the Institute to employ the results of the study
performed under paragraph (1) and the best methods
identified by the Institute for the purpose of identifying existing and new clinical practice guidelines that
were developed using such best methods, including
guidelines listed in the National Guideline Clearinghouse.
‘‘(B) CONSULTATION.—In carrying out the identification process under subparagraph (A), the Secretary
shall allow for consultation with professional societies, voluntary health care organizations, and expert
panels.’’
IOM STUDY ON DRUG SAFETY AND QUALITY
Pub. L. 108–173, title I, § 107(c), Dec. 8, 2003, 117 Stat.
2170, provided that:
‘‘(1) IN GENERAL.—The Secretary [of Health and
Human Services] shall enter into a contract with the
Institutes of Medicine of the National Academies of
Science (such Institutes referred to in this subsection
as the ‘IOM’) to carry out a comprehensive study (in
this subsection referred to as the ‘study’) of drug safety
and quality issues in order to provide a blueprint for
system-wide change.
‘‘(2) OBJECTIVES.—
‘‘(A) The study shall develop a full understanding of
drug safety and quality issues through an evidencebased review of literature, case studies, and analysis.
This review will consider the nature and causes of
medication errors, their impact on patients, the differences in causation, impact, and prevention across
multiple dimensions of health care delivery-including
patient populations, care settings, clinicians, and institutional cultures.
‘‘(B) The study shall attempt to develop credible estimates of the incidence, severity, costs of medica-

Page 866

tion errors that can be useful in prioritizing resources for national quality improvement efforts and
influencing national health care policy.
‘‘(C) The study shall evaluate alternative approaches to reducing medication errors in terms of
their efficacy, cost-effectiveness, appropriateness in
different settings and circumstances, feasibility, institutional barriers to implementation, associated
risks, and the quality of evidence supporting the approach.
‘‘(D) The study shall provide guidance to consumers, providers, payers, and other key stakeholders on
high-priority strategies to achieve both short-term
and long-term drug safety goals, to elucidate the
goals and expected results of such initiatives and support the business case for them, and to identify critical success factors and key levers for achieving success.
‘‘(E) The study shall assess the opportunities and
key impediments to broad nationwide implementation of medication error reductions, and to provide
guidance to policy-makers and government agencies
(including the Food and Drug Administration, the
Centers for Medicare & Medicaid Services, and the
National Institutes of Health) in promoting a national agenda for medication error reduction.
‘‘(F) The study shall develop an applied research
agenda to evaluate the health and cost impacts of alternative interventions, and to assess collaborative
public and private strategies for implementing the
research agenda through AHRQ and other government agencies.
‘‘(3) CONDUCT OF STUDY.—
‘‘(A) EXPERT COMMITTEE.—In conducting the study,
the IOM shall convene a committee of leading experts
and key stakeholders in pharmaceutical management
and drug safety, including clinicians, health services
researchers, pharmacists, system administrators,
payer representatives, and others.
‘‘(B) COMPLETION.—The study shall be completed
within an 18-month period.
‘‘(4) REPORT.—A report on the study shall be submitted to Congress upon the completion of the study.
‘‘(5) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
such sums as may be necessary.’’
HEALTH CARE THAT WORKS FOR ALL AMERICANS:
CITIZENS HEALTH CARE WORKING GROUP
Pub. L. 108–173, title X, § 1014, Dec. 8, 2003, 117 Stat.
2441, directed the Secretary of Health and Human Services to establish the Citizens’ Health Care Working
Group, composed of the Secretary and 14 other members, which was to hold hearings to examine various
public and private health care coverage issues, make
final recommendations to the President and Congress,
and terminate 2 years after the members were chosen
(Feb. 28, 2005) and appropriations were first made available.
EXECUTIVE ORDER NO. 13017
Ex. Ord. No. 13017, Sept. 5, 1996, 61 F.R. 47659, as
amended by Ex. Ord. No. 13040, Mar. 25, 1997, 62 F.R.
14773; Ex. Ord. No. 13056, July 21, 1997, 62 F.R. 39415,
which established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, was revoked by Ex. Ord. No. 13138, § 3(a), Sept. 30,
1999, 64 F.R. 53880, formerly set out as a note under section 14 of the Federal Advisory Committee Act in the
Appendix to Title 5, Government Organization and Employees.

§ 299a. General authorities
(a) In general
In carrying out section 299(b) of this title, the
Director shall conduct and support research,
evaluations, and training, support demonstration projects, research networks, and multidisci-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

plinary centers, provide technical assistance,
and disseminate information on health care and
on systems for the delivery of such care, including activities with respect to—
(1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
(2) quality measurement and improvement;
(3) the outcomes, cost, cost-effectiveness,
and use of health care services and access to
such services;
(4) clinical practice, including primary care
and practice-oriented research;
(5) health care technologies, facilities, and
equipment;
(6) health care costs, productivity, organization, and market forces;
(7) health promotion and disease prevention,
including clinical preventive services;
(8) health statistics, surveys, database development, and epidemiology; and
(9) medical liability.
(b) Health services training grants
(1) In general
The Director may provide training grants in
the field of health services research related to
activities authorized under subsection (a) of
this section, to include pre- and post-doctoral
fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this
subsection, the Director shall make use of
funds made available under section 288(d)(3) of
this title as well as other appropriated funds.
(2) Requirements
In developing priorities for the allocation of
training funds under this subsection, the Director shall take into consideration shortages
in the number of trained researchers who are
addressing health care issues for the priority
populations identified in section 299(c)(1)(B) of
this title and in addition, shall take into consideration indications of long-term commitment, amongst applicants for training funds,
to addressing health care needs of the priority
populations.
(c) Multidisciplinary centers
The Director may provide financial assistance
to assist in meeting the costs of planning and
establishing new centers, and operating existing
and new centers, for multidisciplinary health
services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a)
of this section.
(d) Relation to certain authorities regarding social security
Activities authorized in this section shall be
appropriately coordinated with experiments,
demonstration projects, and other related activities authorized by the Social Security Act
[42 U.S.C. 301 et seq.] and the Social Security
Amendments of 1967. Activities under subsection
(a)(2) of this section that affect the programs
under titles XVIII, XIX and XXI of the Social
Security Act [42 U.S.C. 1395 et seq., 1396 et seq.,
1397aa et seq.] shall be carried out consistent
with section 1142 of such Act [42 U.S.C. 1320b–12].

§ 299a

(e) Disclaimer
The Agency shall not mandate national standards of clinical practice or quality health care
standards. Recommendations resulting from
projects funded and published by the Agency
shall include a corresponding disclaimer.
(f) Rule of construction
Nothing in this section shall be construed to
imply that the Agency’s role is to mandate a national standard or specific approach to quality
measurement and reporting. In research and
quality improvement activities, the Agency
shall consider a wide range of choices, providers,
health care delivery systems, and individual
preferences.
(July 1, 1944, ch. 373, title IX, § 902, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1654;
amended Pub. L. 106–525, title II, § 201(a)(1), Nov.
22, 2000, 114 Stat. 2505.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (d), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, which is classified
generally to chapter 7 (§ 301 et seq.) of this title. Titles
XVIII, XIX, and XXI of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of
this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
The Social Security Amendments of 1967, referred to
in subsec. (d), is Pub. L. 90–248, Jan. 2, 1968, 81 Stat. 821,
as amended. For complete classification of this Act to
the Code, see Short Title of 1968 Amendment note set
out under section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 299a, act July 1, 1944, ch. 373, title IX,
§ 902, as added Pub. L. 101–239, title VI, § 6103(a), Dec. 19,
1989, 103 Stat. 2189; amended Pub. L. 101–639, § 3(d), Nov.
28, 1990, 104 Stat. 4603; Pub. L. 102–410, § 2(b), Oct. 13,
1992, 106 Stat. 2094, required Administrator to conduct
and support research, demonstration projects, evaluations, training, guideline development, and dissemination of information on health care services and on systems for delivery of such services, prior to the general
amendment of this subchapter by Pub. L. 106–129.
Another prior section 299a, act July 1, 1944, ch. 373,
title IX, § 901, as added Oct. 6, 1965, Pub. L. 89–239, § 2,
79 Stat. 926; amended Oct. 15, 1968, Pub. L. 90–574, title
I, §§ 101, 102, 107, 82 Stat. 1005, 1006; June 30, 1970, Pub.
L. 91–296, title IV, § 401(b)(1)(F), 84 Stat. 352; Oct. 30,
1970, Pub. L. 91–515, title I, § 103, 84 Stat. 1298; June 18,
1973, Pub. L. 93–45, title I, § 110, 87 Stat. 93, authorized
appropriations for grants and contracts to carry out
purposes of this subchapter and set forth extent of and
limitations on grants, prior to repeal by Pub. L. 99–117,
§ 12(d), Oct. 7, 1985, 99 Stat. 495.
A prior section 902 of act July 1, 1944, was classified
to section 299b of this title prior to repeal by Pub. L.
99–117.
AMENDMENTS
2000—Subsec. (g). Pub. L. 106–525 struck out heading
and text of subsec. (g). Text read as follows: ‘‘Beginning
with fiscal year 2003, the Director shall annually submit to the Congress a report regarding prevailing disparities in health care delivery as it relates to racial
factors and socioeconomic factors in priority populations.’’
REDUCING ADMINISTRATIVE HEALTH CARE COSTS
Pub. L. 103–43, title XIX, § 1909, June 10, 1993, 107 Stat.
205, as amended by Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999,
113 Stat. 1670; Pub. L. 108–173, title IX, § 900(e)(6)(F),
Dec. 8, 2003, 117 Stat. 2374, provided that: ‘‘The Sec-

§ 299a–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

retary of Health and Human Services, acting through
the Agency for Healthcare Research and Quality and,
to the extent possible, in consultation with the Centers
for Medicare & Medicaid Services, may fund research to
develop a text-based standardized billing process,
through the utilization of text-based information retrieval and natural language processing techniques applied to automatic coding and analysis of textual patient discharge summaries and other text-based electronic medical records, within a parallel general purpose (shared memory) high performance computing environment. The Secretary shall determine whether
such a standardized approach to medical billing,
through the utilization of the text-based hospital discharge summary as well as electronic patient records
can reduce the administrative billing costs of health
care delivery.’’
DEMONSTRATION GRANTS FOR THE DEVELOPMENT, IMPLEMENTATION, AND EVALUATION OF ALTERNATIVES TO THE
CURRENT MEDICAL LIABILITY SYSTEM
Memorandum of President of the United States, Sept.
17, 2009, 74 F.R. 48133, provided:
Memorandum for the Secretary of Health And Human
Services
As part of my Administration’s ongoing effort to reform our health care system, we have reached out to
members of both political parties and listened to the
concerns many have raised about the need to improve
patient safety and to reform our medical liability system. Between 44,000 and 98,000 patients die each year
from medical errors. Many physicians continue to
struggle to pay their medical malpractice premiums,
which vary tremendously by specialty and by State.
The cost of insurance continues to be one of the highest
practice expenses for some specialties. And although
malpractice premiums do not account for a large percentage of total medical costs, many physicians report
that fear of lawsuits leads them to practice defensive
medicine, which may contribute to higher costs.
We should explore medical liability reform as one
way to improve the quality of care and patient-safety
practices and to reduce defensive medicine. But whatever steps we pursue, medical liability reform must be
just one part of broader health insurance reform—reform that offers more security and stability to Americans who have insurance, offers insurance to Americans
who lack coverage, and slows the growth of health care
costs for families, businesses, and government.
In recent years, there have been calls from organizations like The Joint Commission and the Institute of
Medicine to begin funding demonstration projects that
can test a variety of medical liability models and determine which reforms work. These groups and others
have identified several important goals and core commitments of malpractice reform that should serve as a
starting point for such projects. We must put patient
safety first and work to reduce preventable injuries. We
must foster better communication between doctors and
their patients. We must ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits. And we must work to reduce liability premiums.
In 1999, the Congress authorized the Agency for
Healthcare Research and Quality, which is located
within the Department of Health and Human Services,
to support demonstration projects and to evaluate the
effectiveness of projects regarding all aspects of health
care, including medical liability. I hereby request that
you announce, within 30 days of this memorandum,
that the Department will make available demonstration grants to States, localities, and health systems for
the development, implementation, and evaluation of alternatives to our current medical liability system, consistent with the goals and core commitments outlined
above.
This memorandum is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or enti-

Page 868

ties, its officers, employees, or agents, or any other
person.
You are authorized and directed to publish this
memorandum in the Federal Register.
BARACK OBAMA.

§ 299a–1. Research on health disparities
(a) In general
The Director shall—
(1) conduct and support research to identify
populations for which there is a significant
disparity in the quality, outcomes, cost, or use
of health care services or access to and satisfaction with such services, as compared to the
general population;
(2) conduct and support research on the
causes of and barriers to reducing the health
disparities identified in paragraph (1), taking
into account such factors as socioeconomic
status, attitudes toward health, the language
spoken, the extent of formal education, the
area or community in which the population
resides, and other factors the Director determines to be appropriate;
(3) conduct and support research and support
demonstration projects to identify, test, and
evaluate strategies for reducing or eliminating
health disparities, including development or
identification of effective service delivery
models, and disseminate effective strategies
and models;
(4) develop measures and tools for the assessment and improvement of the outcomes, quality, and appropriateness of health care services provided to health disparity populations;
(5) in carrying out section 299a(c) of this
title, provide support to increase the number
of researchers who are members of health disparity populations, and the health services research capacity of institutions that train such
researchers; and
(6) beginning with fiscal year 2003, annually
submit to the Congress a report regarding prevailing disparities in health care delivery as it
relates to racial factors and socioeconomic
factors in priority populations.
(b) Research and demonstration projects
(1) In general
In carrying out subsection (a) of this section, the Director shall conduct and support
research and support demonstrations to—
(A) identify the clinical, cultural, socioeconomic, geographic, and organizational
factors that contribute to health disparities,
including minority health disparity populations, which research shall include behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach, and the availability of related support services (such as
cultural and linguistic services);
(B) identify and evaluate clinical and organizational strategies to improve the quality,
outcomes, and access to care for health disparity populations, including minority
health disparity populations;
(C) test such strategies and widely disseminate those strategies for which there is
scientific evidence of effectiveness; and
(D) determine the most effective approaches for disseminating research findings

Page 869

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to health disparity populations, including
minority populations.
(2) Use of certain strategies
In carrying out this section, the Director
shall implement research strategies and mechanisms that will enhance the involvement of
individuals who are members of minority
health disparity populations or other health
disparity populations, health services researchers who are such individuals, institutions that train such individuals as researchers, members of minority health disparity populations or other health disparity populations
for whom the Agency is attempting to improve the quality and outcomes of care, and
representatives of appropriate tribal or other
community-based organizations with respect
to health disparity populations. Such research
strategies and mechanisms may include the
use of—
(A) centers of excellence that can demonstrate, either individually or through consortia, a combination of multi-disciplinary
expertise in outcomes or quality improvement research, linkages to relevant sites of
care, and a demonstrated capacity to involve
members and communities of health disparity populations, including minority health
disparity populations, in the planning, conduct, dissemination, and translation of research;
(B) provider-based research networks, including health plans, facilities, or delivery
system sites of care (especially primary
care), that make extensive use of health care
providers who are members of health disparity populations or who serve patients in such
populations and have the capacity to evaluate and promote quality improvement;
(C) service delivery models (such as health
centers under section 254b of this title and
the Indian Health Service) to reduce health
disparities; and
(D) innovative mechanisms or strategies
that will facilitate the translation of past
research investments into clinical practices
that can reasonably be expected to benefit
these populations.
(c) Quality measurement development
(1) In general
To ensure that health disparity populations,
including minority health disparity populations, benefit from the progress made in the
ability of individuals to measure the quality
of health care delivery, the Director shall support the development of quality of health care
measures that assess the experience of such
populations with health care systems, such as
measures that assess the access of such populations to health care, the cultural competence of the care provided, the quality of the
care provided, the outcomes of care, or other
aspects of health care practice that the Director determines to be important.
(2) Examination of certain practices
The Director shall examine the practices of
providers that have a record of reducing
health disparities or have experience in providing culturally competent health services to

§ 299a–1

minority health disparity populations or other
health disparity populations. In examining
such practices of providers funded under the
authorities of this chapter, the Director shall
consult with the heads of the relevant agencies of the Public Health Service.
(3) Report
Not later than 36 months after November 22,
2000, the Secretary, acting through the Director, shall prepare and submit to the appropriate committees of Congress a report describing the state-of-the-art of quality measurement for minority and other health disparity populations that will identify critical
unmet needs, the current activities of the Department to address those needs, and a description of related activities in the private
sector.
(d) Definition
For purposes of this section:
(1) The term ‘‘health disparity population’’
has the meaning given such term in section
285t of this title, except that in addition to the
meaning so given, the Director may determine
that such term includes populations for which
there is a significant disparity in the quality,
outcomes, cost, or use of health care services
or access to or satisfaction with such services
as compared to the general population.
(2) The term ‘‘minority’’, with respect to
populations, refers to racial and ethnic minority groups as defined in section 300u–6 of this
title.
(July 1, 1944, ch. 373, title IX, § 903, as added Pub.
L. 106–525, title II, § 201(a)(2), Nov. 22, 2000, 114
Stat. 2505; amended Pub. L. 111–148, title X,
§ 10334(c)(3)(B), Mar. 23, 2010, 124 Stat. 974.)
PRIOR PROVISIONS
A prior section 299a–1, act July 1, 1944, ch. 373, title
IX, § 903, as added Pub. L. 101–239, title VI, § 6103(a), Dec.
19, 1989, 103 Stat. 2190; amended Pub. L. 102–410, § 3, Oct.
13, 1992, 106 Stat. 2094; Pub. L. 103–43, title XIV, § 1422(a),
June 10, 1993, 107 Stat. 172, related to public dissemination of information about studies and projects prior to
the general amendment of this subchapter by Pub. L.
106–129. See section 299c–3 of this title.
A prior section 903 of act July 1, 1944, was classified
to section 299c of this title prior to repeal by Pub. L.
99–117.
Prior sections 299a–2 and 299a–3 were omitted in the
general amendment of this subchapter by Pub. L.
106–129.
Section 299a–2, act July 1, 1944, ch. 373, title IX, § 904,
as added Pub. L. 101–239, title VI, § 6103(a), Dec. 19, 1989,
103 Stat. 2191; amended Pub. L. 102–410, § 4(a), Oct. 13,
1992, 106 Stat. 2095; Pub. L. 103–43, title XX, § 2013(1),
June 10, 1993, 107 Stat. 214, related to health care technology assessment. See section 299b–5 of this title.
Section 299a–3, act July 1, 1944, ch. 373, title IX, § 905,
as added Pub. L. 105–115, title IV, § 409, Nov. 21, 1997, 111
Stat. 2371, established demonstration program regarding centers for education and research on therapeutics.
See section 299b–1(b) of this title.
AMENDMENTS
2010—Subsec. (d)(1). Pub. L. 111–148 substituted ‘‘285t’’
for ‘‘287c–31’’.

§ 299b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 870

PART B—HEALTH CARE IMPROVEMENT RESEARCH

§ 299b–1. Private-public partnerships to improve
organization and delivery

§ 299b. Health care outcome improvement research

(a) Support for efforts to develop information on
quality
(1) Scientific and technical support
In its role as the principal agency for health
care research and quality, the Agency may
provide scientific and technical support for
private and public efforts to improve health
care quality, including the activities of accrediting organizations.
(2) Role of the Agency
With respect to paragraph (1), the role of the
Agency shall include—
(A) the identification and assessment of
methods for the evaluation of the health of—
(i) enrollees in health plans by type of
plan, provider, and provider arrangements;
and
(ii) other populations, including those
receiving long-term care services;

(a) Evidence rating systems
In collaboration with experts from the public
and private sector, the Agency shall identify
and disseminate methods or systems to assess
health care research results, particularly methods or systems to rate the strength of the scientific evidence underlying health care practice,
recommendations in the research literature, and
technology assessments. The Agency shall make
methods or systems for evidence rating widely
available.
Agency
publications
containing
health care recommendations shall indicate the
level of substantiating evidence using such
methods or systems.
(b) Health care improvement research centers
and provider-based research networks
(1) In general
In order to address the full continuum of
care and outcomes research, to link research
to practice improvement, and to speed the dissemination of research findings to community
practice settings, the Agency shall employ research strategies and mechanisms that will
link research directly with clinical practice in
geographically diverse locations throughout
the United States, including—
(A) health care improvement research centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care;
(B) provider-based research networks, including plan, facility, or delivery system
sites of care (especially primary care), that
can evaluate outcomes and evaluate and promote quality improvement; and
(C) other innovative mechanisms or strategies to link research with clinical practice.
(2) Requirements
The Director is authorized to establish the
requirements for entities applying for grants
under this subsection.
(July 1, 1944, ch. 373, title IX, § 911, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1656.)
PRIOR PROVISIONS
A prior section 299b, act July 1, 1944, ch. 373, title IX,
§ 911, as added Pub. L. 101–239, title VI, § 6103(a), Dec. 19,
1989, 103 Stat. 2192; amended Pub. L. 102–410, § 5(b), Oct.
13, 1992, 106 Stat. 2097, related to establishment of Office of the Forum for Quality and Effectiveness in
Health Care, prior to the general amendment of this
subchapter by Pub. L. 106–129.
Another prior section 299b, act July 1, 1944, ch. 373,
title IX, § 902, as added Oct. 6, 1965, Pub. L. 89–239, § 2,
79 Stat. 927; amended Oct. 15, 1968, Pub. L. 90–574, title
I, § 103, 82 Stat. 1005; Oct. 30, 1970, Pub. L. 91–515, title
I, §§ 104, 111(b), 84 Stat. 1299, 1301, defined terms for purposes of this subchapter, prior to repeal by Pub. L.
99–117, § 12(d), Oct. 7, 1985, 99 Stat. 495.

(B) the ongoing development, testing, and
dissemination of quality measures, including
measures of health and functional outcomes;
(C) the compilation and dissemination of
health care quality measures developed in
the private and public sector;
(D) assistance in the development of improved health care information systems;
(E) the development of survey tools for the
purpose of measuring participant and beneficiary assessments of their health care; and
(F) identifying and disseminating information on mechanisms for the integration of
information on quality into purchaser and
consumer decision-making processes.
(b) Centers for education and research on therapeutics
(1) In general
The Secretary, acting through the Director
and in consultation with the Commissioner of
Food and Drugs, shall establish a program for
the purpose of making one or more grants for
the establishment and operation of one or
more centers to carry out the activities specified in paragraph (2).
(2) Required activities
The activities referred to in this paragraph
are the following:
(A) The conduct of state-of-the-art research for the following purposes:
(i) To increase awareness of—
(I) new uses of drugs, biological products, and devices;
(II) ways to improve the effective use
of drugs, biological products, and devices; and
(III) risks of new uses and risks of combinations of drugs and biological products.
(ii) To provide objective clinical information to the following individuals and
entities:
(I) Health care practitioners and other
providers of health care goods or services.
(II) Pharmacists, pharmacy benefit
managers and purchasers.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(III) Health maintenance organizations
and other managed health care organizations.
(IV) Health care insurers and governmental agencies.
(V) Patients and consumers.
(iii) To improve the quality of health
care while reducing the cost of health care
through—
(I) an increase in the appropriate use of
drugs, biological products, or devices;
and
(II) the prevention of adverse effects of
drugs, biological products, and devices
and the consequences of such effects,
such as unnecessary hospitalizations.
(B) The conduct of research on the comparative effectiveness, cost-effectiveness,
and safety of drugs, biological products, and
devices.
(C) Such other activities as the Secretary
determines to be appropriate, except that a
grant may not be expended to assist the Secretary in the review of new drugs, biological
products, and devices.
(c) Reducing errors in medicine
The Director shall, in accordance with part C
of this subchapter, conduct and support research
and build private-public partnerships to—
(1) identify the causes of preventable health
care errors and patient injury in health care
delivery;
(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and
(3) disseminate such effective strategies
throughout the health care industry.
(July 1, 1944, ch. 373, title IX, § 912, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1656;
amended Pub. L. 109–41, § 2(a)(1), July 29, 2005, 119
Stat. 424.)
PRIOR PROVISIONS
A prior section 299b–1, act July 1, 1944, ch. 373, title
IX, § 912, as added Pub. L. 101–239, title VI, § 6103(a), Dec.
19, 1989, 103 Stat. 2192; amended Pub. L. 102–410,
§§ 5(a)(1), (c)(1), 6(b), Oct. 13, 1992, 106 Stat. 2096, 2097,
2100, related to the duties of the Office of the Forum for
Quality and Effectiveness in Health Care, prior to the
general amendment of this subchapter by Pub. L.
106–129.
AMENDMENTS
2005—Subsec. (c). Pub. L. 109–41 inserted ‘‘, in accordance with part C of this subchapter,’’ after ‘‘The Director shall’’ in introductory provisions.

§ 299b–2. Information on quality and cost of care
(a) In general
The Director shall—
(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001
and subsequent fiscal years, quality of health
care, including the types of health care services Americans use, their access to health care
services, frequency of use, how much is paid
for the services used, the source of those payments, the types and costs of private health
insurance, access, satisfaction, and quality of

§ 299b–3

care for the general population including rural
residents and also for populations identified in
section 299(c) of this title; and
(2) develop databases and tools that provide
information to States on the quality, access,
and use of health care services provided to
their residents.
(b) Quality and outcomes information
(1) In general
Beginning in fiscal year 2001, the Director
shall ensure that the survey conducted under
subsection (a)(1) of this section will—
(A) identify determinants of health outcomes and functional status, including the
health care needs of populations identified
in section 299(c) of this title, provide data to
study the relationships between health care
quality, outcomes, access, use, and cost,
measure changes over time, and monitor the
overall national impact of Federal and State
policy changes on health care;
(B) provide information on the quality of
care and patient outcomes for frequently occurring clinical conditions for a nationally
representative sample of the population including rural residents; and
(C) provide reliable national estimates for
children and persons with special health
care needs through the use of supplements or
periodic expansions of the survey.
In expanding the Medical Expenditure Panel
Survey, as in existence on December 6, 1999, in
fiscal year 2001 to collect information on the
quality of care, the Director shall take into
account any outcomes measurements generally collected by private sector accreditation
organizations.
(2) Annual report
Beginning in fiscal year 2003, the Secretary,
acting through the Director, shall submit to
Congress an annual report on national trends
in the quality of health care provided to the
American people.
(July 1, 1944, ch. 373, title IX, § 913, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1658.)
CODIFICATION
December 6, 1999, referred to in subsec. (b)(1), was in
the original ‘‘the date of the enactment of this title’’,
which was translated as meaning the date of enactment
of Pub. L. 106–129, which amended this subchapter generally, to reflect the probable intent of Congress.
PRIOR PROVISIONS
A prior section 299b–2, act July 1, 1944, ch. 373, title
IX, § 913, as added Pub. L. 101–239, title VI, § 6103(a), Dec.
19, 1989, 103 Stat. 2193; amended Pub. L. 102–410, § 5(c)(2),
(f)(1)(A), Oct. 13, 1992, 106 Stat. 2097, 2098, related to development of guidelines and standards, prior to the
general amendment of this subchapter by Pub. L.
106–129.

§ 299b–3. Information systems for health care improvement
(a) In general
In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall
conduct and support research, evaluations, and
initiatives to advance—

§ 299b–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) the use of information systems for the
study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance
data;
(2) training for health care practitioners and
researchers in the use of information systems;
(3) the creation of effective linkages between
various sources of health information, including the development of information networks;
(4) the delivery and coordination of evidence-based health care services, including the
use of real-time health care decision-support
programs;
(5) the utility and comparability of health
information data and medical vocabularies by
addressing issues related to the content, structure, definitions and coding of such information and data in consultation with appropriate
Federal, State and private entities;
(6) the use of computer-based health records
in all settings for the development of personal
health records for individual health assessment and maintenance, and for monitoring
public health and outcomes of care within populations; and
(7) the protection of individually identifiable
information in health services research and
health care quality improvement.
(b) Demonstration
The Agency shall support demonstrations into
the use of new information tools aimed at improving shared decision-making between patients and their care-givers.
(c) Facilitating public access to information
The Director shall work with appropriate public and private sector entities to facilitate public access to information regarding the quality
of and consumer satisfaction with health care.
(July 1, 1944, ch. 373, title IX, § 914, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1658.)
PRIOR PROVISIONS
A prior section 299b–3, act July 1, 1944, ch. 373, title
IX, § 914, as added Pub. L. 101–239, title VI, § 6103(a), Dec.
19, 1989, 103 Stat. 2193; amended Pub. L. 102–410,
§§ 5(c)(3), 6(a), 7, Oct. 13, 1992, 106 Stat. 2097, 2099, 2100;
Pub. L. 103–43, title XX, § 2013(2), June 10, 1993, 107 Stat.
215, related to creation of an agenda and additional requirements, prior to the general amendment of this
subchapter by Pub. L. 106–129.

§ 299b–4. Research supporting primary care and
access in underserved areas
(a) Preventive Services Task Force
(1) Establishment and purpose
The Director shall convene an independent
Preventive Services Task Force (referred to in
this subsection as the ‘‘Task Force’’) to be
composed of individuals with appropriate expertise. Such Task Force shall review the scientific evidence related to the effectiveness,
appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care
community, and updating previous clinical
preventive recommendations, to be published
in the Guide to Clinical Preventive Services
(referred to in this section as the ‘‘Guide’’), for

Page 872

individuals and organizations delivering clinical services, including primary care professionals, health care systems, professional societies, employers, community organizations,
non-profit organizations, Congress and other
policy-makers, governmental public health
agencies, health care quality organizations,
and organizations developing national health
objectives. Such recommendations shall consider clinical preventive best practice recommendations from the Agency for Healthcare
Research and Quality, the National Institutes
of Health, the Centers for Disease Control and
Prevention, the Institute of Medicine, specialty medical associations, patient groups,
and scientific societies.
(2) Duties
The duties of the Task Force shall include—
(A) the development of additional topic
areas for new recommendations and interventions related to those topic areas, including those related to specific sub-populations
and age groups;
(B) at least once during every 5-year period, review 1 interventions and update 2 recommendations related to existing topic
areas, including new or improved techniques
to assess the health effects of interventions;
(C) improved integration with Federal
Government health objectives and related
target setting for health improvement;
(D) the enhanced dissemination of recommendations;
(E) the provision of technical assistance to
those health care professionals, agencies and
organizations that request help in implementing the Guide 3 recommendations; and
(F) the submission of yearly reports to
Congress and related agencies identifying
gaps in research, such as preventive services
that receive an insufficient evidence statement, and recommending priority areas that
deserve further examination, including areas
related to populations and age groups not
adequately addressed by current recommendations.
(3) Role of Agency
The Agency shall provide ongoing administrative, research, and technical support for
the operations of the Task Force, including
coordinating and supporting the dissemination
of the recommendations of the Task Force, ensuring adequate staff resources, and assistance
to those organizations requesting it for implementation of the Guide’s recommendations.
(4) Coordination with Community Preventive
Services Task Force
The Task Force shall take appropriate steps
to coordinate its work with the Community
Preventive Services Task Force and the Advisory Committee on Immunization Practices,
including the examination of how each task
force’s recommendations interact at the nexus
of clinic and community.
1 So

in original. Probably should be ‘‘review of’’.
in original. Probably should be ‘‘updating of’’.
3 So in original. Probably should be ‘‘Guide’s’’.
2 So

Page 873

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Operation
Operation.4 In carrying out the duties under
paragraph (2), the Task Force is not subject to
the provisions of Appendix 2 of title 5.
(6) Independence
All members of the Task Force convened
under this subsection, and any recommendations made by such members, shall be independent and, to the extent practicable, not
subject to political pressure.
(7) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary for each fiscal year
to carry out the activities of the Task Force.
(b) Primary care research
(1) In general
There is established within the Agency a
Center for Primary Care Research (referred to
in this subsection as the ‘‘Center’’) that shall
serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research
focuses on the first contact when illness or
health concerns arise, the diagnosis, treatment or referral to specialty care, preventive
care, and the relationship between the clinician and the patient in the context of the family and community.
(2) Research
In carrying out this section, the Center shall
conduct and support research concerning—
(A) the nature and characteristics of primary care practice;
(B) the management of commonly occurring clinical problems;
(C) the management of undifferentiated
clinical problems; and
(D) the continuity and coordination of
health services.
(July 1, 1944, ch. 373, title IX, § 915, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1659;
amended Pub. L. 111–148, title IV, § 4003(a), Mar.
23, 2010, 124 Stat. 541.)
REFERENCES IN TEXT
Appendix 2 of title 5, referred to in subsec. (a)(5),
probably means the Federal Advisory Committee Act,
Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out
in the Appendix to Title 5, Government Organization
and Employees.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148 added subsec. (a) and
struck out former subsec. (a) which related to establishment and purpose of Preventive Services Task
Force, provision of support by Agency, and nonapplicability of provisions of Appendix 2 of title 5.

§ 299b–4a. Studies on preventive interventions in
primary care for older Americans
(a) Studies
The Secretary of Health and Human Services,
acting through the United States Preventive
Services Task Force, shall conduct a series of
studies designed to identify preventive interven4 So

in original.

§ 299b–5

tions that can be delivered in the primary care
setting and that are most valuable to older
Americans.
(b) Mission statement
The mission statement of the United States
Preventive Services Task Force is amended to
include the evaluation of services that are of
particular relevance to older Americans.
(c) Report
Not later than 1 year after December 21, 2000,
and annually thereafter, the Secretary of Health
and Human Services shall submit to Congress a
report on the conclusions of the studies conducted under subsection (a) of this section, together with recommendations for such legislation and administrative actions as the Secretary
considers appropriate.
(Pub. L. 106–554, § 1(a)(6) [title I, § 126], Dec. 21,
2000, 114 Stat. 2763, 2763A–479.)
CODIFICATION
Section was enacted as part of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection
Act of 2000, and also as part of the Consolidated Appropriations Act, 2001, and not as part of the Public Health
Service Act which comprises this chapter.

§ 299b–5. Health care practice and technology innovation
(a) In general
The Director shall promote innovation in evidence-based health care practices and technologies by—
(1) conducting and supporting research on
the development, diffusion, and use of health
care technology;
(2) developing, evaluating, and disseminating methodologies for assessments of health
care practices and technologies;
(3) conducting intramural and supporting extramural assessments of existing and new
health care practices and technologies;
(4) promoting education and training and
providing technical assistance in the use of
health care practice and technology assessment methodologies and results; and
(5) working with the National Library of
Medicine and the public and private sector to
develop an electronic clearinghouse of currently available assessments and those in
progress.
(b) Specification of process
(1) In general
Not later than December 31, 2000, the Director shall develop and publish a description of
the methods used by the Agency and its contractors for health care practice and technology assessment.
(2) Consultations
In carrying out this subsection, the Director
shall cooperate and consult with the Assistant
Secretary for Health, the Administrator of the
Centers for Medicare & Medicaid Services, the
Director of the National Institutes of Health,
the Commissioner of Food and Drugs, and the
heads of any other interested Federal department or agency, and shall seek input, where

§ 299b–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

appropriate, from professional societies and
other private and public entities.
(3) Methodology
The Director shall, in developing the methods used under paragraph (1), consider—
(A) safety, efficacy, and effectiveness;
(B) legal, social, and ethical implications;
(C) costs, benefits, and cost-effectiveness;
(D) comparisons to alternate health care
practices and technologies; and
(E) requirements of Food and Drug Administration approval to avoid duplication.
(c) Specific assessments
(1) In general
The Director shall conduct or support specific assessments of health care technologies
and practices.
(2) Requests for assessments
The Director is authorized to conduct or
support assessments, on a reimbursable basis,
for the Centers for Medicare & Medicaid Services, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private
entities.
(3) Grants and contracts
In addition to conducting assessments, the
Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose
of conducting assessments of experimental,
emerging, existing, or potentially outmoded
health care technologies, and for related activities.
(4) Eligible entities
An entity described in this paragraph is an
entity that is determined to be appropriate by
the Director, including academic medical centers, research institutions and organizations,
professional organizations, third party payers,
governmental agencies, minority institutions
of higher education (such as Historically
Black Colleges and Universities, and Hispanic
institutions), and consortia of appropriate research entities established for the purpose of
conducting technology assessments.
(d) Medical examination of certain victims
(1) In general
The Director shall develop and disseminate a
report on evidence-based clinical practices
for—
(A) the examination and treatment by
health professionals of individuals who are
victims of sexual assault (including child
molestation) or attempted sexual assault;
and
(B) the training of health professionals, in
consultation with the Health Resources and
Services Administration, on performing
medical evidentiary examinations of individuals who are victims of child abuse or neglect, sexual assault, elder abuse, or domestic violence.
(2) Certain considerations
In identifying the issues to be addressed by
the report, the Director shall, to the extent

Page 874

practicable, take into consideration the expertise and experience of Federal and State law
enforcement officials regarding the victims referred to in paragraph (1), and of other appropriate public and private entities (including
medical societies, victim services organizations, sexual assault prevention organizations,
and social services organizations).
(July 1, 1944, ch. 373, title IX, § 916, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1660; Pub.
L. 108–173, title IX, § 900(e)(2)(C), Dec. 8, 2003, 117
Stat. 2372.)
AMENDMENTS
2003—Subsecs. (b)(2), (c)(2). Pub. L. 108–173 substituted
‘‘Centers for Medicare & Medicaid Services’’ for
‘‘Health Care Financing Administration’’.

§ 299b–6. Coordination of Federal Government
quality improvement efforts
(a) Requirement
(1) In general
To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health
services research, quality measurement and
quality improvement activities undertaken
and supported by the Federal Government.
(2) Specific activities
The Director, in collaboration with the appropriate Federal officials representing all
concerned executive agencies and departments, shall develop and manage a process
to—
(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research;
(B) strengthen the research information
infrastructure, including databases, pertaining to Federal health services research and
health care quality improvement initiatives;
(C) set specific goals for participating
agencies and departments to further health
services research and health care quality improvement; and
(D) strengthen the management of Federal
health care quality improvement programs.
(b) Study by the Institute of Medicine
(1) In general
To provide Congress, the Department of
Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality
improvement and quality research programs,
the Secretary shall enter into a contract with
the Institute of Medicine—
(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through—
(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal
programs, with particular attention paid

Page 875

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to those under titles XVIII, XIX, and XXI
of the Social Security Act [42 U.S.C. 1395
et seq., 1396 et seq., 1397aa et seq.]; and
(ii) a summary of the partnerships that
the Department of Health and Human
Services has pursued with private accreditation, quality measurement and improvement organizations; and
(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through—
(i) the improved coordination of activities across the medicare, medicaid and
child health insurance programs under
titles XVIII, XIX and XXI of the Social Security Act and health services research
programs;
(ii) the strengthening of patient choice
and participation by incorporating stateof-the-art quality monitoring tools and
making information on quality available;
and
(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various Federal agencies.
(2) Requirements
(A) In general
The Secretary shall enter into a contract
with the Institute of Medicine for the preparation—
(i) not later than 12 months after December 6, 1999, of a report providing an overview of the quality improvement programs
of the Department of Health and Human
Services for the medicare, medicaid, and
CHIP programs under titles XVIII, XIX,
and XXI of the Social Security Act; and
(ii) not later than 24 months after December 6, 1999, of a final report containing
recommendations.
(B) Reports
The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of
the Senate and the Committee on Ways and
Means and the Committee on Commerce of
the House of Representatives.
(July 1, 1944, ch. 373, title IX, § 917, as added Pub.
L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1661.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII, XIX,
and XXI of the Act are classified generally to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.), and
XXI (§ 1397aa et seq.), respectively, of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
CODIFICATION
December 6, 1999, referred to in subsec. (b)(2)(A), was
in the original ‘‘the date of the enactment of this
title’’, which was translated as meaning the date of enactment of Pub. L. 106–129, which amended this subchapter generally, to reflect the probable intent of Congress.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of

§ 299b–7

House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 299b–7. Research on outcomes of health care
items and services
(a) Research, demonstrations, and evaluations
(1) Improvement of effectiveness and efficiency
(A) In general
To improve the quality, effectiveness, and
efficiency of health care delivered pursuant
to the programs established under titles
XVIII, XIX, and XXI of the Social Security
Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa
et seq.], the Secretary 1 acting through the
Director of the Agency for Healthcare Research and Quality (in this section referred
to as the ‘‘Director’’), shall conduct and support research to meet the priorities and requests for scientific evidence and information identified by such programs with respect to—
(i) the outcomes, comparative clinical
effectiveness, and appropriateness of
health care items and services (including
prescription drugs); and
(ii) strategies for improving the efficiency and effectiveness of such programs,
including the ways in which such items
and services are organized, managed, and
delivered under such programs.
(B) Specification
To respond to priorities and information
requests in subparagraph (A), the Secretary
may conduct or support, by grant, contract,
or interagency agreement, research, demonstrations, evaluations, technology assessments, or other activities, including the provision of technical assistance, scientific expertise, or methodological assistance.
(2) Priorities
(A) In general
The Secretary shall establish a process to
develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
(B) Initial list
Not later than 6 months after December 8,
2003, the Secretary shall establish an initial
list of priorities for research related to
health care items and services (including
prescription drugs).
(C) Process
In carrying out subparagraph (A), the Secretary—
(i) shall ensure that there is broad and
ongoing consultation with relevant stakeholders in identifying the highest priorities for research, demonstrations, and
evaluations to support and improve the
programs established under titles XVIII,
XIX, and XXI of the Social Security Act
[42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et
seq.];
1 So

in original. Probably should be followed by a comma.

§ 299b–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) may include health care items and
services which impose a high cost on such
programs, as well as those which may be
underutilized or overutilized and which
may significantly improve the prevention,
treatment, or cure of diseases and conditions (including chronic conditions) which
impose high direct or indirect costs on patients or society; and
(iii) shall ensure that the research and
activities undertaken pursuant to this section are responsive to the specified priorities and are conducted in a timely manner.
(3) Evaluation and synthesis of scientific evidence
(A) In general
The Secretary shall—
(i) evaluate and synthesize available scientific evidence related to health care
items and services (including prescription
drugs) identified as priorities in accordance with paragraph (2) with respect to the
comparative clinical effectiveness, outcomes, appropriateness, and provision of
such items and services (including prescription drugs);
(ii) identify issues for which existing scientific evidence is insufficient with respect
to such health care items and services (including prescription drugs);
(iii) disseminate to prescription drug
plans and MA–PD plans under part D of
title XVIII of the Social Security Act [42
U.S.C. 1395w–101 et seq.], other health
plans, and the public the findings made
under clauses (i) and (ii); and
(iv) work in voluntary collaboration
with public and private sector entities to
facilitate the development of new scientific knowledge regarding health care
items and services (including prescription
drugs).
(B) Initial research
The Secretary shall complete the evaluation and synthesis of the initial research required by the priority list developed under
paragraph (2)(B) not later than 18 months
after the development of such list.
(C) Dissemination
(i) In general
To enhance patient safety and the quality of health care, the Secretary shall
make available and disseminate in appropriate formats to prescription drugs plans
under part D, and MA–PD plans under part
C, of title XVIII of the Social Security Act
[42 U.S.C. 1395w–101 et seq., 1395w–21 et
seq.], other health plans, and the public
the evaluations and syntheses prepared
pursuant to subparagraph (A) and the findings of research conducted pursuant to
paragraph (1). In carrying out this clause
the Secretary, in order to facilitate the
availability of such evaluations and syntheses or findings at every decision point
in the health care system, shall—
(I) present such evaluations and syntheses or findings in a form that is easily

Page 876

understood by the individuals receiving
health care items and services (including
prescription drugs) under such plans and
periodically assess that the requirements of this subclause have been met;
and
(II) provide such evaluations and syntheses or findings and other relevant information through easily accessible and
searchable electronic mechanisms, and
in hard copy formats as appropriate.
(ii) Rule of construction
Nothing in this section shall be construed as—
(I) affecting the authority of the Secretary or the Commissioner of Food and
Drugs under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] or
the Public Health Service Act [42 U.S.C.
201 et seq.]; or
(II) conferring any authority referred
to in subclause (I) to the Director.
(D) Accountability
In carrying out this paragraph, the Secretary shall implement activities in a manner that—
(i) makes publicly available all scientific
evidence relied upon and the methodologies employed, provided such evidence and
method are not protected from public disclosure by section 1905 of title 18 or other
applicable law so that the results of the research, analyses, or syntheses can be evaluated or replicated; and
(ii) ensures that any information needs
and unresolved issues identified in subparagraph (A)(ii) are taken into account in
priority-setting for future research conducted by the Secretary.
(4) Confidentiality
(A) In general
In making use of administrative, clinical,
and program data and information developed
or collected with respect to the programs established under titles XVIII, XIX, and XXI of
the Social Security Act [42 U.S.C. 1395 et
seq., 1396 et seq., 1397aa et seq.], for purposes
of carrying out the requirements of this section or the activities authorized under title
IX of the Public Health Service Act (42
U.S.C. 299 et seq.), such data and information shall be protected in accordance with
the confidentiality requirements of title IX
of the Public Health Service Act.
(B) Rule of construction
Nothing in this section shall be construed
to require or permit the disclosure of data
provided to the Secretary that is otherwise
protected from disclosure under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.], section 1905 of title 18, or other applicable law.
(5) Evaluations
The Secretary shall conduct and support
evaluations of the activities carried out under
this section to determine the extent to which
such activities have had an effect on outcomes

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

and utilization of health care items and services.
(6) Improving information available to health
care providers, patients, and policymakers
Not later than 18 months after December 8,
2003, the Secretary shall identify options that
could be undertaken in voluntary collaboration with private and public entities (as appropriate) for the—
(A) provision of more timely information
through the programs established under
titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq.,
1397aa et seq.], regarding the outcomes and
quality of patient care, including clinical
and patient-reported outcomes, especially
with respect to interventions and conditions
for which clinical trials would not be feasible or raise ethical concerns that are difficult to address;
(B) acceleration of the adoption of innovation and quality improvement under such
programs; and
(C) development of management tools for
the programs established under titles XIX
and XXI of the Social Security Act [42 U.S.C.
1396 et seq., 1397aa et seq.], and with respect
to the programs established under such
titles, assess the feasibility of using administrative or claims data, to—
(i) improve oversight by State officials;
(ii) support Federal and State initiatives
to improve the quality, safety, and efficiency of services provided under such programs; and
(iii) provide a basis for estimating the
fiscal and coverage impact of Federal or
State program and policy changes.
(b) Recommendations
(1) Disclaimer
In carrying out this section, the Director
shall—
(A) not mandate national standards of
clinical practice or quality health care
standards; and
(B) include in any recommendations resulting from projects funded and published
by the Director, a corresponding reference to
the prohibition described in subparagraph
(A).
(2) Requirement for implementation
Research, evaluation, and communication
activities performed pursuant to this section
shall reflect the principle that clinicians and
patients should have the best available evidence upon which to make choices in health
care items and services, in providers, and in
health care delivery systems, recognizing that
patient subpopulations and patient and physician preferences may vary.
(3) Rule of construction
Nothing in this section shall be construed to
provide the Director with authority to mandate a national standard or require a specific
approach to quality measurement and reporting.
(c) Research with respect to dissemination
The Secretary, acting through the Director,
may conduct or support research with respect to

§ 299b–8

improving methods of disseminating information in accordance with subsection (a)(3)(C) of
this section.
(d) Limitation on CMS
The Administrator of the Centers for Medicare
& Medicaid Services may not use data obtained
in accordance with this section to withhold coverage of a prescription drug.
(e) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $50,000,000 for fiscal year
2004, and such sums as may be necessary for
each fiscal year thereafter.
(Pub. L. 108–173, title X, § 1013, Dec. 8, 2003, 117
Stat. 2438.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(a)(1)(A), (2)(C)(i), (3)(A)(iii), (C)(i), (4)(A), (6)(A), (C), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles
XVIII, XIX, and XXI of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of
this title. Parts C and D of title XVIII of the Act are
classified generally to parts C (§ 1395w–21 et seq.) and D
(§ 1395w–101 et seq.), respectively, of subchapter XVIII of
chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (a)(3)(C)(ii)(I), (4)(B), is act June 25, 1938,
ch. 675, 52 Stat. 1040, as amended, which is classified
generally to chapter 9 (§ 301 et seq.) of Title 21, Food
and Drugs. For complete classification of this Act to
the Code, see section 301 of Title 21 and Tables.
The Public Health Service Act, referred to in subsec.
(a)(3)(C)(ii)(I), (4)(A), is act July 1, 1944, ch. 373, 58 Stat.
682, as amended, which is classified generally to this
chapter. Title IX of the Act is classified generally to
this subchapter. For complete classification of this Act
to the Code, see Short Title note set out under section
201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of
2003, and not as part of the Public Health Service Act
which comprises this chapter.
DEFINITION OF ‘‘SECRETARY’’
‘‘Secretary’’ as meaning the Secretary of Health and
Human Services, see section 1(c)(2) of Pub. L. 108–173,
set out as a note under section 1301 of this title.

§ 299b–8. Federal Coordinating Council for Comparative Effectiveness Research
(a) Establishment
There is hereby established a Federal Coordinating Council for Comparative Effectiveness
Research (in this section referred to as the
‘‘Council’’).
(b) Purpose
The Council shall foster optimum coordination of comparative effectiveness and related
health services research conducted or supported
by relevant Federal departments and agencies,
with the goal of reducing duplicative efforts and
encouraging coordinated and complementary
use of resources.
(c) Duties
The Council shall—

§ 299b–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) assist the offices and agencies of the Federal Government, including the Departments
of Health and Human Services, Veterans Affairs, and Defense, and other Federal departments or agencies, to coordinate the conduct
or support of comparative effectiveness and related health services research; and
(2) advise the President and Congress on—
(A) strategies with respect to the infrastructure needs of comparative effectiveness
research within the Federal Government;
and
(B) organizational expenditures for comparative effectiveness research by relevant
Federal departments and agencies.
(d) Membership
(1) Number and appointment
The Council shall be composed of not more
than 15 members, all of whom are senior Federal officers or employees with responsibility
for health-related programs, appointed by the
President, acting through the Secretary of
Health and Human Services (in this section referred to as the ‘‘Secretary’’). Members shall
first be appointed to the Council not later
than 30 days after February 17, 2009.
(2) Members
(A) In general
The members of the Council shall include
one senior officer or employee from each of
the following agencies:
(i) The Agency for Healthcare Research
and Quality.
(ii) The Centers for Medicare and Medicaid Services.
(iii) The National Institutes of Health.
(iv) The Office of the National Coordinator for Health Information Technology.
(v) The Food and Drug Administration.
(vi) The Veterans Health Administration
within the Department of Veterans Affairs.
(vii) The office within the Department of
Defense responsible for management of the
Department of Defense Military Health
Care System.
(B) Qualifications
At least half of the members of the Council shall be physicians or other experts with
clinical expertise.
(3) Chairman; Vice Chairman
The Secretary shall serve as Chairman of
the Council and shall designate a member to
serve as Vice Chairman.
(e) Reports
(1) Initial report
Not later than June 30, 2009, the Council
shall submit to the President and the Congress
a report containing information describing
current Federal activities on comparative effectiveness research and recommendations for
such research conducted or supported from
funds made available for allotment by the Secretary for comparative effectiveness research
in this Act.
(2) Annual report
The Council shall submit to the President
and Congress an annual report regarding its

Page 878

activities and recommendations concerning
the infrastructure needs, organizational expenditures and opportunities for better coordination of comparative effectiveness research
by relevant Federal departments and agencies.
(f) Staffing; support
From funds made available for allotment by
the Secretary for comparative effectiveness research in this Act, the Secretary shall make
available not more than 1 percent to the Council
for staff and administrative support.
(g) Rules of construction
(1) Coverage
Nothing in this section shall be construed to
permit the Council to mandate coverage, reimbursement, or other policies for any public or
private payer.
(2) Reports and recommendations
None of the reports submitted under this
section or recommendations made by the
Council shall be construed as mandates or
clinical guidelines for payment, coverage, or
treatment.
(Pub. L. 111–5, div. A, title VIII, § 804, Feb. 17,
2009, 123 Stat. 187.)
REFERENCES IN TEXT
This Act, referred to in subsecs. (e)(1) and (f), is div.
A of Pub. L. 111–5, Feb. 17, 2009, 123 Stat. 116. For complete classification of this Act to the Code, see Tables.
CODIFICATION
Section was enacted as part of the American Recovery and Reinvestment Act of 2009, and not as part of
the Public Health Service Act which comprises this
chapter.
TERMINATION OF FEDERAL COORDINATING COUNCIL FOR
COMPARATIVE EFFECTIVENESS RESEARCH
Pub. L. 111–148, title VI, § 6302, Mar. 23, 2010, 124 Stat.
747, provided that: ‘‘Notwithstanding any other provision of law, the Federal Coordinating Council for Comparative Effectiveness Research established under section 804 of Division A of the American Recovery and
Reinvestment Act of 2009 (42 U.S.C. 299b–8), including
the requirement under subsection (e)(2) of such section,
shall terminate on the date of enactment of this Act
[Mar. 23, 2010].’’

PART C—PATIENT SAFETY IMPROVEMENT
§ 299b–21. Definitions
In this part:
(1) HIPAA confidentiality regulations
The term ‘‘HIPAA confidentiality regulations’’ means regulations promulgated under
section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public
Law 104–191; 110 Stat. 2033).
(2) Identifiable patient safety work product
The term ‘‘identifiable patient safety work
product’’ means patient safety work product
that—
(A) is presented in a form and manner that
allows the identification of any provider
that is a subject of the work product, or any
providers that participate in activities that
are a subject of the work product;
(B) constitutes individually identifiable
health information as that term is defined in
the HIPAA confidentiality regulations; or

Page 879

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) is presented in a form and manner that
allows the identification of an individual
who reported information in the manner
specified in section 299b–22(e) of this title.
(3) Nonidentifiable patient safety work product
The term ‘‘nonidentifiable patient safety
work product’’ means patient safety work
product that is not identifiable patient safety
work product (as defined in paragraph (2)).
(4) Patient safety organization
The term ‘‘patient safety organization’’
means a private or public entity or component
thereof that is listed by the Secretary pursuant to section 299b–24(d) of this title.
(5) Patient safety activities
The term ‘‘patient safety activities’’ means
the following activities:
(A) Efforts to improve patient safety and
the quality of health care delivery.
(B) The collection and analysis of patient
safety work product.
(C) The development and dissemination of
information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices.
(D) The utilization of patient safety work
product for the purposes of encouraging a
culture of safety and of providing feedback
and assistance to effectively minimize patient risk.
(E) The maintenance of procedures to preserve confidentiality with respect to patient
safety work product.
(F) The provision of appropriate security
measures with respect to patient safety
work product.
(G) The utilization of qualified staff.
(H) Activities related to the operation of a
patient safety evaluation system and to the
provision of feedback to participants in a patient safety evaluation system.
(6) Patient safety evaluation system
The term ‘‘patient safety evaluation system’’ means the collection, management, or
analysis of information for reporting to or by
a patient safety organization.
(7) Patient safety work product
(A) In general
Except as provided in subparagraph (B),
the term ‘‘patient safety work product’’
means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements—
(i) which—
(I) are assembled or developed by a
provider for reporting to a patient safety
organization and are reported to a patient safety organization; or
(II) are developed by a patient safety
organization for the conduct of patient
safety activities;
and which could result in improved patient
safety, health care quality, or health care
outcomes; or
(ii) which identify or constitute the deliberations or analysis of, or identify the

§ 299b–21

fact of reporting pursuant to, a patient
safety evaluation system.
(B) Clarification
(i) Information described in subparagraph
(A) does not include a patient’s medical
record, billing and discharge information, or
any other original patient or provider
record.
(ii) Information described in subparagraph
(A) does not include information that is collected, maintained, or developed separately,
or exists separately, from a patient safety
evaluation system. Such separate information or a copy thereof reported to a patient
safety organization shall not by reason of its
reporting be considered patient safety work
product.
(iii) Nothing in this part shall be construed to limit—
(I) the discovery of or admissibility of
information described in this subparagraph in a criminal, civil, or administrative proceeding;
(II) the reporting of information described in this subparagraph to a Federal,
State, or local governmental agency for
public health surveillance, investigation,
or other public health purposes or health
oversight purposes; or
(III) a provider’s recordkeeping obligation with respect to information described
in this subparagraph under Federal, State,
or local law.
(8) Provider
The term ‘‘provider’’ means—
(A) an individual or entity licensed or
otherwise authorized under State law to provide health care services, including—
(i) a hospital, nursing facility, comprehensive outpatient rehabilitation facility,
home health agency, hospice program,
renal dialysis facility, ambulatory surgical
center, pharmacy, physician or health care
practitioner’s office, long term care facility, behavior health residential treatment
facility, clinical laboratory, or health center; or
(ii) a physician, physician assistant,
nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist,
certified nurse midwife, psychologist, certified social worker, registered dietitian or
nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or
(B) any other individual or entity specified
in regulations promulgated by the Secretary.
(July 1, 1944, ch. 373, title IX, § 921, as added Pub.
L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 424.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in par. (1), is section 264(c) of Pub. L. 104–191, which is set out as a note
under section 1320d–2 of this title.
PRIOR PROVISIONS
A prior section 921 of act July 1, 1944, was renumbered
section 941 and is classified to section 299c of this title.

§ 299b–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Another prior section 921 of act July 1, 1944, was classified to section 299c of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–22. Privilege and confidentiality protections
(a) Privilege
Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work
product shall be privileged and shall not be—
(1) subject to a Federal, State, or local civil,
criminal, or administrative subpoena or order,
including in a Federal, State, or local civil or
administrative disciplinary proceeding against
a provider;
(2) subject to discovery in connection with a
Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative
disciplinary proceeding against a provider;
(3) subject to disclosure pursuant to section
552 of title 5 (commonly known as the Freedom of Information Act) or any other similar
Federal, State, or local law;
(4) admitted as evidence in any Federal,
State, or local governmental civil proceeding,
criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) admitted in a professional disciplinary
proceeding of a professional disciplinary body
established or specifically authorized under
State law.
(b) Confidentiality of patient safety work product
Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work
product shall be confidential and shall not be
disclosed.
(c) Exceptions
Except as provided in subsection (g)(3) of this
section—
(1) Exceptions from privilege and confidentiality
Subsections (a) and (b) of this section shall
not apply to (and shall not be construed to
prohibit) one or more of the following disclosures:
(A) Disclosure of relevant patient safety
work product for use in a criminal proceeding, but only after a court makes an in camera determination that such patient safety
work product contains evidence of a criminal act and that such patient safety work
product is material to the proceeding and
not reasonably available from any other
source.
(B) Disclosure of patient safety work product to the extent required to carry out subsection (f)(4)(A) of this section.
(C) Disclosure of identifiable patient safety work product if authorized by each provider identified in such work product.
(2) Exceptions from confidentiality
Subsection (b) of this section shall not apply
to (and shall not be construed to prohibit) one
or more of the following disclosures:

Page 880

(A) Disclosure of patient safety work product to carry out patient safety activities.
(B) Disclosure of nonidentifiable patient
safety work product.
(C) Disclosure of patient safety work product to grantees, contractors, or other entities carrying out research, evaluation, or
demonstration projects authorized, funded,
certified, or otherwise sanctioned by rule or
other means by the Secretary, for the purpose of conducting research to the extent
that disclosure of protected health information would be allowed for such purpose under
the HIPAA confidentiality regulations.
(D) Disclosure by a provider to the Food
and Drug Administration with respect to a
product or activity regulated by the Food
and Drug Administration.
(E) Voluntary disclosure of patient safety
work product by a provider to an accrediting
body that accredits that provider.
(F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part.
(G) Disclosure of patient safety work product to law enforcement authorities relating
to the commission of a crime (or to an event
reasonably believed to be a crime) if the person making the disclosure believes, reasonably under the circumstances, that the patient safety work product that is disclosed is
necessary for criminal law enforcement purposes.
(H) With respect to a person other than a
patient safety organization, the disclosure of
patient safety work product that does not
include materials that—
(i) assess the quality of care of an identifiable provider; or
(ii) describe or pertain to one or more actions or failures to act by an identifiable
provider.
(3) Exception from privilege
Subsection (a) of this section shall not apply
to (and shall not be construed to prohibit) voluntary disclosure of nonidentifiable patient
safety work product.
(d) Continued protection of information after
disclosure
(1) In general
Patient safety work product that is disclosed under subsection (c) of this section
shall continue to be privileged and confidential as provided for in subsections (a) and (b)
of this section, and such disclosure shall not
be treated as a waiver of privilege or confidentiality, and the privileged and confidential nature of such work product shall also apply to
such work product in the possession or control
of a person to whom such work product was
disclosed.
(2) Exception
Notwithstanding paragraph (1), and subject
to paragraph (3)—
(A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections provided for in subsection (b) of this section shall no longer
apply to the work product so disclosed; and

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B)
of this section (relating to disclosure of nonidentifiable patient safety work product),
the privilege and confidentiality protections
provided for in subsections (a) and (b) of this
section shall no longer apply to such work
product.
(3) Construction
Paragraph (2) shall not be construed as terminating or limiting the privilege or confidentiality protections provided for in subsection
(a) or (b) of this section with respect to patient safety work product other than the specific patient safety work product disclosed as
provided for in subsection (c) of this section.
(4) Limitations on actions
(A) Patient safety organizations
(i) In general
A patient safety organization shall not
be compelled to disclose information collected or developed under this part whether or not such information is patient safety work product unless such information is
identified, is not patient safety work product, and is not reasonably available from
another source.
(ii) Nonapplication
The limitation contained in clause (i)
shall not apply in an action against a patient safety organization or with respect
to disclosures pursuant to subsection (c)(1)
of this section.
(B) Providers
An accrediting body shall not take an accrediting action against a provider based on
the good faith participation of the provider
in the collection, development, reporting, or
maintenance of patient safety work product
in accordance with this part. An accrediting
body may not require a provider to reveal its
communications with any patient safety organization established in accordance with
this part.
(e) Reporter protection
(1) In general
A provider may not take an adverse employment action, as described in paragraph (2),
against an individual based upon the fact that
the individual in good faith reported information—
(A) to the provider with the intention of
having the information reported to a patient
safety organization; or
(B) directly to a patient safety organization.
(2) Adverse employment action
For purposes of this subsection, an ‘‘adverse
employment action’’ includes—
(A) loss of employment, the failure to promote an individual, or the failure to provide
any other employment-related benefit for
which the individual would otherwise be eligible; or
(B) an adverse evaluation or decision made
in relation to accreditation, certification,
credentialing, or licensing of the individual.

§ 299b–22

(f) Enforcement
(1) Civil monetary penalty
Subject to paragraphs (2) and (3), a person
who discloses identifiable patient safety work
product in knowing or reckless violation of
subsection (b) of this section shall be subject
to a civil monetary penalty of not more than
$10,000 for each act constituting such violation.
(2) Procedure
The provisions of section 1320a–7a of this
title, other than subsections (a) and (b) and
the first sentence of subsection (c)(1), shall
apply to civil money penalties under this subsection in the same manner as such provisions
apply to a penalty or proceeding under section
1320a–7a of this title.
(3) Relation to HIPAA
Penalties shall not be imposed both under
this subsection and under the regulations issued pursuant to section 264(c)(1) of the Health
Insurance Portability and Accountability Act
of 1996 (42 U.S.C. 1320d–2 note) for a single act
or omission.
(4) Equitable relief
(A) In general
Without limiting remedies available to
other parties, a civil action may be brought
by any aggrieved individual to enjoin any
act or practice that violates subsection (e) of
this section and to obtain other appropriate
equitable relief (including reinstatement,
back pay, and restoration of benefits) to redress such violation.
(B) Against State employees
An entity that is a State or an agency of
a State government may not assert the
privilege described in subsection (a) of this
section unless before the time of the assertion, the entity or, in the case of and with
respect to an agency, the State has consented to be subject to an action described
in subparagraph (A), and that consent has
remained in effect.
(g) Rule of construction
Nothing in this section shall be construed—
(1) to limit the application of other Federal,
State, or local laws that provide greater privilege or confidentiality protections than the
privilege and confidentiality protections provided for in this section;
(2) to limit, alter, or affect the requirements
of Federal, State, or local law pertaining to
information that is not privileged or confidential under this section;
(3) except as provided in subsection (i) of
this section, to alter or affect the implementation of any provision of the HIPAA confidentiality regulations or section 1320d–5 of this
title (or regulations promulgated under such
section);
(4) to limit the authority of any provider,
patient safety organization, or other entity to
enter into a contract requiring greater confidentiality or delegating authority to make a
disclosure or use in accordance with this section;

§ 299b–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) as preempting or otherwise affecting any
State law requiring a provider to report information that is not patient safety work product; or
(6) to limit, alter, or affect any requirement
for reporting to the Food and Drug Administration information regarding the safety of a
product or activity regulated by the Food and
Drug Administration.
(h) Clarification
Nothing in this part prohibits any person from
conducting additional analysis for any purpose
regardless of whether such additional analysis
involves issues identical to or similar to those
for which information was reported to or assessed by a patient safety organization or a patient safety evaluation system.
(i) Clarification of application of HIPAA confidentiality regulations to patient safety organizations
For purposes of applying the HIPAA confidentiality regulations—
(1) patient safety organizations shall be
treated as business associates; and
(2) patient safety activities of such organizations in relation to a provider are deemed to
be health care operations (as defined in such
regulations) of the provider.
(j) Reports on strategies to improve patient safety
(1) Draft report
Not later than the date that is 18 months
after any network of patient safety databases
is operational, the Secretary, in consultation
with the Director, shall prepare a draft report
on effective strategies for reducing medical errors and increasing patient safety. The draft
report shall include any measure determined
appropriate by the Secretary to encourage the
appropriate use of such strategies, including
use in any federally funded programs. The Secretary shall make the draft report available
for public comment and submit the draft report to the Institute of Medicine for review.
(2) Final report
Not later than 1 year after the date described in paragraph (1), the Secretary shall
submit a final report to the Congress.
(July 1, 1944, ch. 373, title IX, § 922, as added Pub.
L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 427.)
REFERENCES IN TEXT
Section 264(c)(1) of the Health Insurance Portability
and Accountability Act of 1996, referred to in subsec.
(f)(3), is section 264(c)(1) of Pub. L. 104–191, which is set
out as a note under section 1320d–2 of this title.
PRIOR PROVISIONS
A prior section 922 of act July 1, 1944, was renumbered
section 942 and is classified to section 299c–1 of this
title.
Another prior section 922 of act July 1, 1944, was classified to section 299c–1 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–23. Network of patient safety databases
(a) In general
The Secretary shall facilitate the creation of,
and maintain, a network of patient safety data-

Page 882

bases that provides an interactive evidencebased management resource for providers, patient safety organizations, and other entities.
The network of databases shall have the capacity to accept, aggregate across the network, and
analyze nonidentifiable patient safety work
product voluntarily reported by patient safety
organizations, providers, or other entities. The
Secretary shall assess the feasibility of providing for a single point of access to the network
for qualified researchers for information aggregated across the network and, if feasible, provide for implementation.
(b) Data standards
The Secretary may determine common formats for the reporting to and among the network of patient safety databases maintained
under subsection (a) of this section of nonidentifiable patient safety work product, including necessary work product elements, common
and consistent definitions, and a standardized
computer interface for the processing of such
work product. To the extent practicable, such
standards shall be consistent with the administrative simplification provisions of part C of
title XI of the Social Security Act [42 U.S.C.
1320d et seq.].
(c) Use of information
Information reported to and among the network of patient safety databases under subsection (a) of this section shall be used to analyze national and regional statistics, including
trends and patterns of health care errors. The
information resulting from such analyses shall
be made available to the public and included in
the annual quality reports prepared under section 299b–2(b)(2) of this title.
(July 1, 1944, ch. 373, title IX, § 923, as added Pub.
L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 431.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Part
C of title XI of the Act is classified generally to part
C (§ 1320d et seq.) of subchapter XI of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 923 of act July 1, 1944, was renumbered
section 943 and is classified to section 299c–2 of this
title.
Another prior section 923 of act July 1, 1944, was classified to section 299c–2 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–24. Patient safety organization certification and listing
(a) Certification
(1) Initial certification
An entity that seeks to be a patient safety
organization shall submit an initial certification to the Secretary that the entity—
(A) has policies and procedures in place to
perform each of the patient safety activities
described in section 299b–21(5) of this title;
and
(B) upon being listed under subsection (d)
of this section, will comply with the criteria
described in subsection (b) of this section.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Subsequent certifications
An entity that is a patient safety organization shall submit every 3 years after the date
of its initial listing under subsection (d) of
this section a subsequent certification to the
Secretary that the entity—
(A) is performing each of the patient safety activities described in section 299b–21(5)
of this title; and
(B) is complying with the criteria described in subsection (b) of this section.
(b) Criteria
(1) In general
The following are criteria for the initial and
subsequent certification of an entity as a patient safety organization:
(A) The mission and primary activity of
the entity are to conduct activities that are
to improve patient safety and the quality of
health care delivery.
(B) The entity has appropriately qualified
staff (whether directly or through contract),
including licensed or certified medical professionals.
(C) The entity, within each 24-month period that begins after the date of the initial
listing under subsection (d) of this section,
has bona fide contracts, each of a reasonable
period of time, with more than 1 provider for
the purpose of receiving and reviewing patient safety work product.
(D) The entity is not, and is not a component of, a health insurance issuer (as defined
in section 300gg–91(b)(2) of this title).
(E) The entity shall fully disclose—
(i) any financial, reporting, or contractual relationship between the entity and
any provider that contracts with the entity; and
(ii) if applicable, the fact that the entity
is not managed, controlled, and operated
independently from any provider that contracts with the entity.
(F) To the extent practical and appropriate, the entity collects patient safety
work product from providers in a standardized manner that permits valid comparisons
of similar cases among similar providers.
(G) The utilization of patient safety work
product for the purpose of providing direct
feedback and assistance to providers to effectively minimize patient risk.
(2) Additional criteria for component organizations
If an entity that seeks to be a patient safety
organization is a component of another organization, the following are additional criteria
for the initial and subsequent certification of
the entity as a patient safety organization:
(A) The entity maintains patient safety
work product separately from the rest of the
organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product.
(B) The entity does not make an unauthorized disclosure under this part of patient
safety work product to the rest of the organization in breach of confidentiality.
(C) The mission of the entity does not create a conflict of interest with the rest of the
organization.

§ 299b–24

(c) Review of certification
(1) In general
(A) Initial certification
Upon the submission by an entity of an
initial certification under subsection (a)(1)
of this section, the Secretary shall determine if the certification meets the requirements of subparagraphs (A) and (B) of such
subsection.
(B) Subsequent certification
Upon the submission by an entity of a subsequent certification under subsection (a)(2)
of this section, the Secretary shall review
the certification with respect to requirements of subparagraphs (A) and (B) of such
subsection.
(2) Notice of acceptance or non-acceptance
If the Secretary determines that—
(A) an entity’s initial certification meets
requirements referred to in paragraph (1)(A),
the Secretary shall notify the entity of the
acceptance of such certification; or
(B) an entity’s initial certification does
not meet such requirements, the Secretary
shall notify the entity that such certification is not accepted and the reasons therefor.
(3) Disclosures regarding relationship to providers
The Secretary shall consider any disclosures
under subsection (b)(1)(E) of this section by an
entity and shall make public findings on
whether the entity can fairly and accurately
perform the patient safety activities of a patient safety organization. The Secretary shall
take those findings into consideration in determining whether to accept the entity’s initial certification and any subsequent certification submitted under subsection (a) of this
section and, based on those findings, may
deny, condition, or revoke acceptance of the
entity’s certification.
(d) Listing
The Secretary shall compile and maintain a
listing of entities with respect to which there is
an acceptance of a certification pursuant to subsection (c)(2)(A) of this section that has not been
revoked under subsection (e) of this section or
voluntarily relinquished.
(e) Revocation of acceptance of certification
(1) In general
If, after notice of deficiency, an opportunity
for a hearing, and a reasonable opportunity for
correction, the Secretary determines that a
patient safety organization does not meet the
certification requirements under subsection
(a)(2) of this section, including subparagraphs
(A) and (B) of such subsection, the Secretary
shall revoke the Secretary’s acceptance of the
certification of such organization.
(2) Supplying confirmation of notification to
providers
Within 15 days of a revocation under paragraph (1), a patient safety organization shall
submit to the Secretary a confirmation that
the organization has taken all reasonable ac-

§ 299b–24a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tions to notify each provider whose patient
safety work product is collected or analyzed
by the organization of such revocation.
(3) Publication of decision
If the Secretary revokes the certification of
an organization under paragraph (1), the Secretary shall—
(A) remove the organization from the listing maintained under subsection (d) of this
section; and
(B) publish notice of the revocation in the
Federal Register.
(f) Status of data after removal from listing
(1) New data
With respect to the privilege and confidentiality protections described in section 299b–22
of this title, data submitted to an entity within 30 days after the entity is removed from the
listing under subsection (e)(3)(A) of this section shall have the same status as data submitted while the entity was still listed.
(2) Protection to continue to apply
If the privilege and confidentiality protections described in section 299b–22 of this title
applied to patient safety work product while
an entity was listed, or to data described in
paragraph (1), such protections shall continue
to apply to such work product or data after
the entity is removed from the listing under
subsection (e)(3)(A) of this section.
(g) Disposition of work product and data
If the Secretary removes a patient safety organization from the listing as provided for in
subsection (e)(3)(A) of this section, with respect
to the patient safety work product or data described in subsection (f)(1) of this section that
the patient safety organization received from
another entity, such former patient safety organization shall—
(1) with the approval of the other entity and
a patient safety organization, transfer such
work product or data to such patient safety
organization;
(2) return such work product or data to the
entity that submitted the work product or
data; or
(3) if returning such work product or data to
such entity is not practicable, destroy such
work product or data.
(July 1, 1944, ch. 373, title IX, § 924, as added Pub.
L. 109–41, § 2(a)(5), July 29, 2005, 119 Stat. 431.)
PRIOR PROVISIONS
A prior section 924 of act July 1, 1944, was renumbered
section 944 and is classified to section 299c–3 of this
title.
Another prior section 924 of act July 1, 1944, was classified to section 299c–3 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–24a. Activities regarding women’s health
(a) Establishment
There is established within the Office of the
Director, an Office of Women’s Health and Gender-Based Research (referred to in this section
as the ‘‘Office’’). The Office shall be headed by a
director who shall be appointed by the Director
of Healthcare and Research Quality.

Page 884

(b) Purpose
The official designated under subsection (a)
shall—
(1) report to the Director on the current
Agency level of activity regarding women’s
health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects
of Agency work, including the development of
evidence reports and clinical practice protocols and the conduct of research into patient
outcomes, delivery of health care services,
quality of care, and access to health care;
(2) establish short-range and long-range
goals and objectives within the Agency for research important to women’s health and, as
relevant and appropriate, coordinate with
other appropriate offices on activities within
the Agency that relate to health services and
medical effectiveness research, for issues of
particular concern to women;
(3) identify projects in women’s health that
should be conducted or supported by the Agency;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and
other individuals and groups, as appropriate,
on Agency policy with regard to women; and
(5) serve as a member of the Department of
Health and Human Services Coordinating
Committee on Women’s Health (established
under section 237a(b)(4) of this title).
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2010 through 2014.
(July 1, 1944, ch. 373, title IX, § 925, as added Pub.
L. 111–148, title III, § 3509(e)(2), Mar. 23, 2010, 124
Stat. 534.)
PRIOR PROVISIONS
A prior section 925 of act July 1, 1944, was renumbered
section 926 and is classified to section 299b–25 of this
title.
Another prior section 925 of act July 1, 1944, was renumbered section 945 and is classified to section 299c–4
of this title.
Another prior section 925 of act July 1, 1944, was classified to section 299c–4 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–25. Technical assistance
The Secretary, acting through the Director,
may provide technical assistance to patient
safety organizations, including convening annual meetings for patient safety organizations
to discuss methodology, communication, data
collection, or privacy concerns.
(July 1, 1944, ch. 373, title IX, § 926, formerly § 925,
as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119
Stat. 434; renumbered § 926, Pub. L. 111–148, title
III, § 3509(e)(1), Mar. 23, 2010, 124 Stat. 534.)
PRIOR PROVISIONS
A prior section 926 of act July 1, 1944, was renumbered
section 927 and is classified to section 299b–26 of this
title.
Another prior section 926 of act July 1, 1944, was renumbered section 946 and is classified to section 299c–5
of this title.

Page 885

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Another prior section 926 of act July 1, 1944, was classified to section 299c–5 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299b–26. Severability
If any provision of this part is held to be unconstitutional, the remainder of this part shall
not be affected.
(July 1, 1944, ch. 373, title IX, § 927, formerly § 926,
as added Pub. L. 109–41, § 2(a)(5), July 29, 2005, 119
Stat. 434; renumbered § 927, Pub. L. 111–148, title
III, § 3509(e)(1), Mar. 23, 2010, 124 Stat. 534.)
PRIOR PROVISIONS
A prior section 927 of act July 1, 1944, was renumbered
section 947, and is classified to section 299c–6 of this
title.
Another prior section 927 of act July 1, 1944, was classified to section 299c–6 of this title prior to the general
amendment of this subchapter by Pub. L. 106–129.

PART D—HEALTH CARE QUALITY IMPROVEMENT
PRIOR PROVISIONS
A prior part D, consisting of sections 299c to 299c–7,
was redesignated part E of this subchapter.
SUBPART 1—QUALITY MEASURE DEVELOPMENT

§ 299b–31. Quality measure development
(a) Quality measure
In this subpart, the term ‘‘quality measure’’
means a standard for measuring the performance and improvement of population health or
of health plans, providers of services, and other
clinicians in the delivery of health care services.
(b) Identification of quality measures
(1) Identification
The Secretary, in consultation with the Director of the Agency for Healthcare Research
and Quality and the Administrator of the Centers for Medicare & Medicaid Services, shall
identify, not less often than triennially, gaps
where no quality measures exist and existing
quality measures that need improvement, updating, or expansion, consistent with the national strategy under section 280j of this title,
to the extent available, for use in Federal
health programs. In identifying such gaps and
existing quality measures that need improvement, the Secretary shall take into consideration—
(A) the gaps identified by the entity with
a contract under section 1890(a) of the Social
Security Act [42 U.S.C. 1395aaa(a)] and other
stakeholders;
(B) quality measures identified by the pediatric quality measures program under section 1139A of the Social Security Act [42
U.S.C. 1320b–9a]; and
(C) quality measures identified through
the Medicaid Quality Measurement Program
under section 1139B of the Social Security
Act [42 U.S.C. 1320b–9b].
(2) Publication
The Secretary shall make available to the
public on an Internet website a report on any
gaps identified under paragraph (1) and the
process used to make such identification.

§ 299b–31

(c) Grants or contracts for quality measure development
(1) In general
The Secretary shall award grants, contracts,
or intergovernmental agreements to eligible
entities for purposes of developing, improving,
updating, or expanding quality measures identified under subsection (b).
(2) Prioritization in the development of quality
measures
In awarding grants, contracts, or agreements under this subsection, the Secretary
shall give priority to the development of quality measures that allow the assessment of—
(A) health outcomes and functional status
of patients;
(B) the management and coordination of
health care across episodes of care and care
transitions for patients across the continuum of providers, health care settings, and
health plans;
(C) the experience, quality, and use of information provided to and used by patients,
caregivers, and authorized representatives
to inform decisionmaking about treatment
options, including the use of shared decisionmaking tools and preference sensitive care
(as defined in section 299b–36 of this title);
(D) the meaningful use of health information technology;
(E) the safety, effectiveness, patientcenteredness, appropriateness, and timeliness of care;
(F) the efficiency of care;
(G) the equity of health services and
health disparities across health disparity
populations (as defined in section 285t 1 of
this title) and geographic areas;
(H) patient experience and satisfaction;
(I) the use of innovative strategies and
methodologies identified under section
299b–33 of this title; and
(J) other areas determined appropriate by
the Secretary.
(3) Eligible entities
To be eligible for a grant or contract under
this subsection, an entity shall—
(A) have demonstrated expertise and capacity in the development and evaluation of
quality measures;
(B) have adopted procedures to include in
the quality measure development process—
(i) the views of those providers or payers
whose performance will be assessed by the
measure; and
(ii) the views of other parties who also
will use the quality measures (such as patients, consumers, and health care purchasers);
(C) collaborate with the entity with a contract under section 1890(a) of the Social Security Act [42 U.S.C. 1395aaa(a)] and other
stakeholders, as practicable, and the Secretary so that quality measures developed
by the eligible entity will meet the requirements to be considered for endorsement by
1 See

References in Text note below.

§ 299b–33

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the entity with a contract under such section 1890(a);
(D) have transparent policies regarding
governance and conflicts of interest; and
(E) submit an application to the Secretary
at such time and in such manner, as the Secretary may require.
(4) Use of funds
An entity that receives a grant, contract, or
agreement under this subsection shall use
such award to develop quality measures that
meet the following requirements:
(A) Such measures support measures required to be reported under the Social Security Act [42 U.S.C. 301 et seq.], where applicable, and in support of gaps and existing
quality measures that need improvement, as
described in subsection (b)(1)(A).
(B) Such measures support measures developed under section 1139A of the Social Security Act [42 U.S.C. 1320b–9a] and the Medicaid Quality Measurement Program under
section 1139B of such Act [42 U.S.C. 1320b–9b],
where applicable.
(C) To the extent practicable, data on such
quality measures is able to be collected
using health information technologies.
(D) Each quality measure is free of charge
to users of such measure.
(E) Each quality measure is publicly available on an Internet website.
(d) Other activities by the Secretary
The Secretary may use amounts available
under this section to update and test, where applicable, quality measures endorsed by the entity with a contract under section 1890(a) of the
Social Security Act [42 U.S.C. 1395aaa(a)] or
adopted by the Secretary.
(e) Coordination of grants
The Secretary shall ensure that grants or contracts awarded under this section are coordinated with grants and contracts awarded under
sections 1139A(5) 2 and 1139B(4)(A) 2 of the Social
Security Act.
(f) Development of outcome measures
(1) In general
The Secretary shall develop, and periodically update (not less than every 3 years), provider-level outcome measures for hospitals
and physicians, as well as other providers as
determined appropriate by the Secretary.
(2) Categories of measures
The measures developed under this subsection shall include, to the extent determined
appropriate by the Secretary—
(A) outcome measurement for acute and
chronic diseases, including, to the extent
feasible, the 5 most prevalent and resourceintensive acute and chronic medical conditions; and
(B) outcome measurement for primary and
preventative care, including, to the extent
feasible, measurements that cover provision
of such care for distinct patient populations
(such as healthy children, chronically ill
adults, or infirm elderly individuals).
2 So

in original. The subsection designation is missing.

Page 886

(3) Goals
In developing such measures, the Secretary
shall seek to—
(A) address issues regarding risk adjustment, accountability, and sample size;
(B) include the full scope of services that
comprise a cycle of care; and
(C) include multiple dimensions.
(4) Timeframe
(A) Acute and chronic diseases
Not later than 24 months after March 23,
2010,1 the Secretary shall develop not less
than 10 measures described in paragraph
(2)(A).
(B) Primary and preventive care
Not later than 36 months after March 23,
2010,1 the Secretary shall develop not less
than 10 measures described in paragraph
(2)(B).
(July 1, 1944, ch. 373, title IX, § 931, as added and
amended Pub. L. 111–148, title III, § 3013(a)(4),
title X, § 10303(a), Mar. 23, 2010, 124 Stat. 381, 937.)
REFERENCES IN TEXT
Section 285t of this title, referred to in subsec.
(c)(2)(G), was in the original ‘‘section 485E’’, meaning
section 485E of act July 1, 1944, which was renumbered
section
464z–3
by
Pub.
L.
111–148,
title
X,
§ 10334(c)(1)(D)(i), Mar. 23, 2010, 124 Stat. 973, and is classified to section 285t of this title. The act of July 1,
1944, no longer contains a section 485E.
The Social Security Act, referred to in subsec.
(c)(4)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, which
is classified generally to chapter 7 (§ 301 et seq.) of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
March 23, 2010, referred to in subsec. (f)(4)(A), (B), was
in the original ‘‘the date of enactment of this Act’’
which was translated as meaning the date of the enactment of Pub. L. 111–148 which added and amended this
section, to reflect the probable intent of Congress.
PRIOR PROVISIONS
A prior section 931 of act July 1, 1944, was renumbered
941 and is classified to section 299c of this title.
AMENDMENTS
2010—Subsec. (f). Pub. L. 111–148, § 10303(a), added subsec. (f).
SUBPART 2—HEALTH CARE QUALITY IMPROVEMENT
PROGRAMS

§ 299b–33. Health care delivery system research
(a) Purpose
The purposes of this section are to—
(1) enable the Director to identify, develop,
evaluate, disseminate, and provide training in
innovative methodologies and strategies for
quality improvement practices in the delivery
of health care services that represent best
practices (referred to as ‘‘best practices’’) in
health care quality, safety, and value; and
(2) ensure that the Director is accountable
for implementing a model to pursue such research in a collaborative manner with other
related Federal agencies.
(b) General functions of the Center
The Center for Quality Improvement and Patient Safety of the Agency for Healthcare Re-

Page 887

TITLE 42—THE PUBLIC HEALTH AND WELFARE

search and Quality (referred to in this section as
the ‘‘Center’’), or any other relevant agency or
department designated by the Director, shall—
(1) carry out its functions using research
from a variety of disciplines, which may include epidemiology, health services, sociology,
psychology, human factors engineering, biostatistics, health economics, clinical research,
and health informatics;
(2) conduct or support activities consistent
with the purposes described in subsection (a),
and for—
(A) best practices for quality improvement
practices in the delivery of health care services; and
(B) that include changes in processes of
care and the redesign of systems used by
providers that will reliably result in intended health outcomes, improve patient
safety, and reduce medical errors (such as
skill development for health care providers
in team-based health care delivery and rapid
cycle process improvement) and facilitate
adoption of improved workflow;
(3) identify health care providers, including
health care systems, single institutions, and
individual providers, that—
(A) deliver consistently high-quality, efficient health care services (as determined by
the Secretary); and
(B) employ best practices that are adaptable and scalable to diverse health care settings or effective in improving care across
diverse settings;
(4) assess research, evidence, and knowledge
about what strategies and methodologies are
most effective in improving health care delivery;
(5) find ways to translate such information
rapidly and effectively into practice, and document the sustainability of those improvements;
(6) create strategies for quality improvement through the development of tools, methodologies, and interventions that can successfully reduce variations in the delivery of
health care;
(7) identify, measure, and improve organizational, human, or other causative factors, including those related to the culture and system design of a health care organization, that
contribute to the success and sustainability of
specific quality improvement and patient safety strategies;
(8) provide for the development of best practices in the delivery of health care services
that—
(A) have a high likelihood of success, based
on structured review of empirical evidence;
(B) are specified with sufficient detail of
the individual processes, steps, training,
skills, and knowledge required for implementation and incorporation into workflow
of health care practitioners in a variety of
settings;
(C) are designed to be readily adapted by
health care providers in a variety of settings; and
(D) where applicable, assist health care
providers in working with other health care

§ 299b–33

providers across the continuum of care and
in engaging patients and their families in
improving the care and patient health outcomes;
(9) provide for the funding of the activities
of organizations with recognized expertise and
excellence in improving the delivery of health
care services, including children’s health care,
by involving multiple disciplines, managers of
health care entities, broad development and
training, patients, caregivers and families, and
frontline health care workers, including activities for the examination of strategies to
share best quality improvement practices and
to promote excellence in the delivery of health
care services; and
(10) build capacity at the State and community level to lead quality and safety efforts
through education, training, and mentoring
programs to carry out the activities under
paragraphs (1) through (9).
(c) Research functions of Center
(1) In general
The Center shall support, such as through a
contract or other mechanism, research on
health care delivery system improvement and
the development of tools to facilitate adoption
of best practices that improve the quality,
safety, and efficiency of health care delivery
services. Such support may include establishing a Quality Improvement Network Research
Program for the purpose of testing, scaling,
and disseminating of interventions to improve
quality and efficiency in health care. Recipients of funding under the Program may include national, State, multi-State, or multisite quality improvement networks.
(2) Research requirements
The research conducted pursuant to paragraph (1) shall—
(A) address the priorities identified by the
Secretary in the national strategic plan established under section 280j of this title;
(B) identify areas in which evidence is insufficient to identify strategies and methodologies, taking into consideration areas of
insufficient evidence identified by the entity
with a contract under section 1395aaa(a) of
this title in the report required under section 280j–2 of this title;
(C) address concerns identified by health
care institutions and providers and communicated through the Center pursuant to subsection (d);
(D) reduce preventable morbidity, mortality, and associated costs of morbidity and
mortality by building capacity for patient
safety research;
(E) support the discovery of processes for
the reliable, safe, efficient, and responsive
delivery of health care, taking into account
discoveries from clinical research and comparative effectiveness research;
(F) allow communication of research findings and translate evidence into practice
recommendations that are adaptable to a variety of settings, and which, as soon as practicable after the establishment of the Center, shall include—

§ 299b–34

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) the implementation of a national application of Intensive Care Unit improvement projects relating to the adult (including geriatric), pediatric, and neonatal
patient populations;
(ii) practical methods for addressing
health care associated infections, including Methicillin-Resistant Staphylococcus
Aureus
and
Vancomycin-Resistant
Entercoccus infections and other emerging
infections; and
(iii) practical methods for reducing preventable hospital admissions and readmissions;
(G) expand demonstration projects for improving the quality of children’s health care
and the use of health information technology, such as through Pediatric Quality
Improvement Collaboratives and Learning
Networks, consistent with provisions of section 1320b–9a of this title for assessing and
improving quality, where applicable;
(H) identify and mitigate hazards by—
(i) analyzing events reported to patient
safety reporting systems and patient safety organizations; and
(ii) using the results of such analyses to
develop scientific methods of response to
such events;
(I) include the conduct of systematic reviews of existing practices that improve the
quality, safety, and efficiency of health care
delivery, as well as new research on improving such practices; and
(J) include the examination of how to
measure and evaluate the progress of quality
and patient safety activities.
(d) Dissemination of research findings
(1) Public availability
The Director shall make the research findings of the Center available to the public
through multiple media and appropriate formats to reflect the varying needs of health
care providers and consumers and diverse levels of health literacy.
(2) Linkage to health information technology
The Secretary shall ensure that research
findings and results generated by the Center
are shared with the Office of the National Coordinator of Health Information Technology
and used to inform the activities of the health
information technology extension program
under section 300jj–32 of this title, as well as
any relevant standards, certification criteria,
or implementation specifications.
(e) Prioritization
The Director shall identify and regularly update a list of processes or systems on which to
focus research and dissemination activities of
the Center, taking into account—
(1) the cost to Federal health programs;
(2) consumer assessment of health care experience;
(3) provider assessment of such processes or
systems and opportunities to minimize distress and injury to the health care workforce;
(4) the potential impact of such processes or
systems on health status and function of pa-

Page 888

tients, including vulnerable populations including children;
(5) the areas of insufficient evidence identified under subsection (c)(2)(B); and
(6) the evolution of meaningful use of health
information technology, as defined in section
300jj of this title.
(f) Coordination
The Center shall coordinate its activities with
activities conducted by the Center for Medicare
and Medicaid Innovation established under section 1315a of this title.
(g) Funding
There is authorized to be appropriated to
carry out this section $20,000,000 for fiscal years
2010 through 2014.
(July 1, 1944, ch. 373, title IX, § 933, as added Pub.
L. 111–148, title III, § 3501, Mar. 23, 2010, 124 Stat.
508.)
PRIOR PROVISIONS
A prior section 933 of act July 1, 1944, was renumbered
section 943 and is classified to section 299c–2 of this
title.

§ 299b–34. Quality improvement technical assistance and implementation
(a) In general
The Director, through the Center for Quality
Improvement and Patient Safety of the Agency
for Healthcare Research and Quality (referred to
in this section as the ‘‘Center’’), shall award—
(1) technical assistance grants or contracts
to eligible entities to provide technical support to institutions that deliver health care
and health care providers (including rural and
urban providers of services and suppliers with
limited infrastructure and financial resources
to implement and support quality improvement activities, providers of services and suppliers with poor performance scores, and providers of services and suppliers for which there
are disparities in care among subgroups of patients) so that such institutions and providers
understand, adapt, and implement the models
and practices identified in the research conducted by the Center, including the Quality
Improvement Networks Research Program;
and
(2) implementation grants or contracts to eligible entities to implement the models and
practices described under paragraph (1).
(b) Eligible entities
(1) Technical assistance award
To be eligible to receive a technical assistance grant or contract under subsection (a)(1),
an entity—
(A) may be a health care provider, health
care provider association, professional society, health care worker organization, Indian
health organization, quality improvement
organization, patient safety organization,
local quality improvement collaborative,
the Joint Commission, academic health center, university, physician-based research
network, primary care extension program
established under section 280g–12 of this
title, a Federal Indian Health Service pro-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

gram or a health program operated by an Indian tribe (as defined in section 1603 of title
25), or any other entity identified by the
Secretary; and
(B) shall have demonstrated expertise in
providing information and technical support
and assistance to health care providers regarding quality improvement.
(2) Implementation award
To be eligible to receive an implementation
grant or contract under subsection (a)(2), an
entity—
(A) may be a hospital or other health care
provider or consortium or 1 providers, as determined by the Secretary; and
(B) shall have demonstrated expertise in
providing information and technical support
and assistance to health care providers regarding quality improvement.
(c) Application
(1) Technical assistance award
To receive a technical assistance grant or
contract under subsection (a)(1), an eligible
entity shall submit an application to the Secretary at such time, in such manner, and containing—
(A) a plan for a sustainable business model
that may include a system of—
(i) charging fees to institutions and providers that receive technical support from
the entity; and
(ii) reducing or eliminating such fees for
such institutions and providers that serve
low-income populations; and
(B) such other information as the Director
may require.
(2) Implementation award
To receive a grant or contract under subsection (a)(2), an eligible entity shall submit
an application to the Secretary at such time,
in such manner, and containing—
(A) a plan for implementation of a model
or practice identified in the research conducted by the Center including—
(i) financial cost, staffing requirements,
and timeline 2 for implementation; and
(ii) pre- and projected post-implementation quality measure performance data in
targeted improvement areas identified by
the Secretary; and
(B) such other information as the Director
may require.
(d) Matching funds
The Director may not award a grant or contract under this section to an entity unless the
entity agrees that it will make available (directly or through contributions from other public or private entities) non-Federal contributions toward the activities to be carried out
under the grant or contract in an amount equal
to $1 for each $5 of Federal funds provided under
the grant or contract. Such non-Federal matching funds may be provided directly or through
donations from public or private entities and
1 So
2 So

in original. Probably should be ‘‘of’’.
in original. Probably should be ‘‘a timeline’’.

§ 299b–35

may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
(e) Evaluation
(1) In general
The Director shall evaluate the performance
of each entity that receives a grant or contract under this section. The evaluation of an
entity shall include a study of—
(A) the success of such entity in achieving
the implementation, by the health care institutions and providers assisted by such entity, of the models and practices identified
in the research conducted by the Center
under section 299b–33 of this title;
(B) the perception of the health care institutions and providers assisted by such entity
regarding the value of the entity; and
(C) where practicable, better patient
health outcomes and lower cost resulting
from the assistance provided by such entity.
(2) Effect of evaluation
Based on the outcome of the evaluation of
the entity under paragraph (1), the Director
shall determine whether to renew a grant or
contract with such entity under this section.
(f) Coordination
The entities that receive a grant or contract
under this section shall coordinate with health
information technology regional extension centers under section 300jj–32(c) of this title and the
primary care extension program established
under section 280g–12 of this title regarding the
dissemination of quality improvement, system
delivery reform, and best practices information.
(July 1, 1944, ch. 373, title IX, § 934, as added and
amended Pub. L. 111–148, title III, § 3501, title X,
§ 10501(f)(3), Mar. 23, 2010, 124 Stat. 511, 996.)
PRIOR PROVISIONS
A prior section 934 of act July 1, 1944, was renumbered
section 944 and is classified to section 299c–3 of this
title.
AMENDMENTS
2010—Subsecs.
(b)(1)(A),
(f).
Pub.
L.
111–148,
§ 10501(f)(3), made technical amendment to reference in
original act which appears in text as reference to section 280g–12 of this title.

§ 299b–35. Grants or contracts to implement
medication management services in treatment of chronic diseases
(a) In general
The Secretary, acting through the Patient
Safety Research Center established in section
299b–33 of this title (referred to in this section as
the ‘‘Center’’), shall establish a program to provide grants or contracts to eligible entities to
implement medication management (referred to
in this section as ‘‘MTM’’) services provided by
licensed pharmacists, as a collaborative, multidisciplinary, inter-professional approach to the
treatment of chronic diseases for targeted individuals, to improve the quality of care and reduce overall cost in the treatment of such diseases. The Secretary shall commence the program under this section not later than May 1,
2010.

§ 299b–35

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Eligible entities
To be eligible to receive a grant or contract
under subsection (a), an entity shall—
(1) provide a setting appropriate for MTM
services, as recommended by the experts described in subsection (e);
(2) submit to the Secretary a plan for
achieving long-term financial sustainability;
(3) where applicable, submit a plan for coordinating MTM services through local community health teams established in section
256a–1 of this title or in collaboration with primary care extension programs established in
section 280g–12 of this title;
(4) submit a plan for meeting the requirements under subsection (c); and
(5) submit to the Secretary such other information as the Secretary may require.
(c) MTM services to targeted individuals
The MTM services provided with the assistance of a grant or contract awarded under subsection (a) shall, as allowed by State law including applicable collaborative pharmacy practice
agreements, include—
(1) performing or obtaining necessary assessments of the health and functional status of
each patient receiving such MTM services;
(2) formulating a medication treatment plan
according to therapeutic goals agreed upon by
the prescriber and the patient or caregiver or
authorized representative of the patient;
(3) selecting, initiating, modifying, recommending changes to, or administering
medication therapy;
(4) monitoring, which may include access to,
ordering, or performing laboratory assessments, and evaluating the response of the patient to therapy, including safety and effectiveness;
(5) performing an initial comprehensive
medication review to identify, resolve, and
prevent medication-related problems, including adverse drug events, quarterly targeted
medication reviews for ongoing monitoring,
and additional followup interventions on a
schedule developed collaboratively with the
prescriber;
(6) documenting the care delivered and communicating essential information about such
care, including a summary of the medication
review, and the recommendations of the pharmacist to other appropriate health care providers of the patient in a timely fashion;
(7) providing education and training designed to enhance the understanding and appropriate use of the medications by the patient, caregiver, and other authorized representative;
(8) providing information, support services,
and resources and strategies designed to enhance patient adherence with therapeutic
regimens;
(9) coordinating and integrating MTM services within the broader health care management services provided to the patient; and
(10) such other patient care services allowed
under pharmacist scopes of practice in use in
other Federal programs that have implemented MTM services.

Page 890

(d) Targeted individuals
MTM services provided by licensed pharmacists under a grant or contract awarded
under subsection (a) shall be offered to targeted
individuals who—
(1) take 4 or more prescribed medications
(including over-the-counter medications and
dietary supplements);
(2) take any ‘‘high risk’’ medications;
(3) have 2 or more chronic diseases, as identified by the Secretary; or
(4) have undergone a transition of care, or
other factors, as determined by the Secretary,
that are likely to create a high risk of medication-related problems.
(e) Consultation with experts
In designing and implementing MTM services
provided under grants or contracts awarded
under subsection (a), the Secretary shall consult
with Federal, State, private, public-private, and
academic entities, pharmacy and pharmacist organizations, health care organizations, consumer advocates, chronic disease groups, and
other stakeholders involved with the research,
dissemination, and implementation of pharmacist-delivered MTM services, as the Secretary
determines appropriate. The Secretary, in collaboration with this group, shall determine
whether it is possible to incorporate rapid cycle
process improvement concepts in use in other
Federal programs that have implemented MTM
services.
(f) Reporting to the Secretary
An entity that receives a grant or contract
under subsection (a) shall submit to the Secretary a report that describes and evaluates, as
requested by the Secretary, the activities carried out under subsection (c), including quality
measures endorsed by the entity with a contract
under section 1395aaa of this title, as determined
by the Secretary.
(g) Evaluation and report
The Secretary shall submit to the relevant
committees of Congress a report which shall—
(1) assess the clinical effectiveness of pharmacist-provided services under the MTM services program, as compared to usual care, including an evaluation of whether enrollees
maintained better health with fewer hospitalizations and emergency room visits than
similar patients not enrolled in the program;
(2) assess changes in overall health care resource use by targeted individuals;
(3) assess patient and prescriber satisfaction
with MTM services;
(4) assess the impact of patient-cost sharing
requirements on medication adherence and
recommendations for modifications;
(5) identify and evaluate other factors that
may impact clinical and economic outcomes,
including demographic characteristics, clinical characteristics, and health services use of
the patient, as well as characteristics of the
regimen, pharmacy benefit, and MTM services
provided; and
(6) evaluate the extent to which participating pharmacists who maintain a dispensing
role have a conflict of interest in the provision
of MTM services, and if such conflict is found,

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

provide recommendations on how such a conflict might be appropriately addressed.
(h) Grants or contracts to fund development of
performance measures
The Secretary may, through the quality measure development program under section 299b–31
of this title, award grants or contracts to eligible entities for the purpose of funding the development of performance measures that assess the
use and effectiveness of medication therapy
management services.
(July 1, 1944, ch. 373, title IX, § 935, as added and
amended Pub. L. 111–148, title III, § 3503, title X,
§ 10501(f)(4), Mar. 23, 2010, 124 Stat. 516, 996.)
PRIOR PROVISIONS
A prior section 935 of act July 1, 1944, was renumbered
section 945 and is classified to section 299c–4 of this
title.
AMENDMENTS
2010—Subsec. (b)(3). Pub. L. 111–148, § 10501(f)(4), made
technical amendment to reference in original act which
appears in text as reference to section 280g–12 of this
title.

§ 299b–36. Program to facilitate shared decisionmaking
(a) Purpose
The purpose of this section is to facilitate collaborative processes between patients, caregivers or authorized representatives, and clinicians that engages 1 the patient, caregiver or authorized representative in decisionmaking, provides 2 patients, caregivers or authorized representatives with information about trade-offs
among treatment options, and facilitates 3 the
incorporation of patient preferences and values
into the medical plan.
(b) Definitions
In this section:
(1) Patient decision aid
The term ‘‘patient decision aid’’ means an
educational tool that helps patients, caregivers or authorized representatives understand and communicate their beliefs and preferences related to their treatment options,
and to decide with their health care provider
what treatments are best for them based on
their treatment options, scientific evidence,
circumstances, beliefs, and preferences.
(2) Preference sensitive care
The term ‘‘preference sensitive care’’ means
medical care for which the clinical evidence
does not clearly support one treatment option
such that the appropriate course of treatment
depends on the values of the patient or the
preferences of the patient, caregivers or authorized representatives regarding the benefits, harms and scientific evidence for each
treatment option, the 4 use of such care should
1 So

in
in
3 So in
4 So in
2 So

original.
original.
original.
original.

Probably
Probably
Probably
Probably

should
should
should
should

be
be
be
be

‘‘engage’’.
‘‘provide’’.
‘‘facilitate’’.
‘‘option. The’’.

§ 299b–36

depend on the informed patient choice among
clinically appropriate treatment options.
(c) Establishment of independent standards for
patient decision aids for preference sensitive
care
(1) Contract with entity to establish standards
and certify patient decision aids
(A) In general
For purposes of supporting consensusbased standards for patient decision aids for
preference sensitive care and a certification
process for patient decision aids for use in
the Federal health programs and by other
interested parties, the Secretary shall have
in effect a contract with the entity with a
contract under section 1395aaa of this title.
Such contract shall provide that the entity
perform the duties described in paragraph
(2).
(B) Timing for first contract
As soon as practicable after March 23, 2010,
the Secretary shall enter into the first contract under subparagraph (A).
(C) Period of contract
A contract under subparagraph (A) shall be
for a period of 18 months (except such contract may be renewed after a subsequent bidding process).
(2) Duties
The following duties are described in this
paragraph:
(A) Develop and identify standards for patient decision aids
The entity shall synthesize evidence and
convene a broad range of experts and key
stakeholders to develop and identify consensus-based standards to evaluate patient decision aids for preference sensitive care.
(B) Endorse patient decision aids
The entity shall review patient decision
aids and develop a certification process
whether 5 patient decision aids meet the
standards developed and identified under
subparagraph (A). The entity shall give priority to the review and certification of patient decision aids for preference sensitive
care.
(d) Program to develop, update and produce patient decision aids to assist health care providers and patients
(1) In general
The Secretary, acting through the Director,
and in coordination with heads of other relevant agencies, such as the Director of the
Centers for Disease Control and Prevention
and the Director of the National Institutes of
Health, shall establish a program to award
grants or contracts—
(A) to develop, update, and produce patient
decision aids for preference sensitive care to
assist health care providers in educating patients, caregivers, and authorized representatives concerning the relative safety, rel5 So

in original.

§ 299b–37

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ative effectiveness (including possible health
outcomes and impact on functional status),
and relative cost of treatment or, where appropriate, palliative care options;
(B) to test such materials to ensure such
materials are balanced and evidence based in
aiding health care providers and patients,
caregivers, and authorized representatives
to make informed decisions about patient
care and can be easily incorporated into a
broad array of practice settings; and
(C) to educate providers on the use of such
materials, including through academic curricula.
(2) Requirements for patient decision aids
Patient decision aids developed and produced pursuant to a grant or contract under
paragraph (1)—
(A) shall be designed to engage patients,
caregivers, and authorized representatives in
informed decisionmaking with health care
providers;
(B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and manner that is
age-appropriate and can be adapted for patients, caregivers, and authorized representatives from a variety of cultural and educational backgrounds to reflect the varying
needs of consumers and diverse levels of
health literacy;
(C) shall, where appropriate, explain why
there is a lack of evidence to support one
treatment option over another; and
(D) shall address health care decisions
across the age span, including those affecting vulnerable populations including children.
(3) Distribution
The Director shall ensure that patient decision aids produced with grants or contracts
under this section are available to the public.
(4) Nonduplication of efforts
The Director shall ensure that the activities
under this section of the Agency and other
agencies, including the Centers for Disease
Control and Prevention and the National Institutes of Health, are free of unnecessary duplication of effort.
(e) Grants to support shared decisionmaking implementation
(1) In general
The Secretary shall establish a program to
provide for the phased-in development, implementation, and evaluation of shared decisionmaking using patient decision aids to meet
the objective of improving the understanding
of patients of their medical treatment options.
(2) Shared decisionmaking resource centers
(A) In general
The Secretary shall provide grants for the
establishment and support of Shared Decisionmaking Resource Centers (referred to in
this subsection as ‘‘Centers’’) to provide
technical assistance to providers and to develop and disseminate best practices and
other information to support and accelerate

Page 892

adoption, implementation, and effective use
of patient decision aids and shared decisionmaking by providers.
(B) Objectives
The objective of a Center is to enhance and
promote the adoption of patient decision
aids and shared decisionmaking through—
(i) providing assistance to eligible providers with the implementation and effective use of, and training on, patient decision aids; and
(ii) the dissemination of best practices
and research on the implementation and
effective use of patient decision aids.
(3) Shared decisionmaking participation grants
(A) In general
The Secretary shall provide grants to
health care providers for the development
and implementation of shared decisionmaking techniques and to assess the use of
such techniques.
(B) Preference
In order to facilitate the use of best practices, the Secretary shall provide a preference in making grants under this subsection to health care providers who participate in training by Shared Decisionmaking
Resource Centers or comparable training.
(C) Limitation
Funds under this paragraph shall not be
used to purchase or implement use of patient decision aids other than those certified
under the process identified in subsection
(c).
(4) Guidance
The Secretary may issue guidance to eligible
grantees under this subsection on the use of
patient decision aids.
(f) Funding
For purposes of carrying out this section there
are authorized to be appropriated such sums as
may be necessary for fiscal year 2010 and each
subsequent fiscal year.
(July 1, 1944, ch. 373, title IX, § 936, as added Pub.
L. 111–148, title III, § 3506, Mar. 23, 2010, 124 Stat.
527.)
PRIOR PROVISIONS
A prior section 936 of act July 1, 1944, was renumbered
section 946 and is classified to section 299c–5 of this
title.

§ 299b–37. Dissemination and building capacity
for research
(a) In general
(1) Dissemination
The Office of Communication and Knowledge
Transfer (referred to in this section as the
‘‘Office’’) at the Agency for Healthcare Research and Quality (or any other relevant office designated by Agency for Healthcare Research and Quality), in consultation with the
National Institutes of Health, shall broadly
disseminate the research findings that are
published by the Patient Centered Outcomes
Research Institute established under section

Page 893

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1320e(b) of this title (referred to in this section
as the ‘‘Institute’’) and other governmentfunded research relevant to comparative clinical effectiveness research. The Office shall create informational tools that organize and disseminate research findings for physicians,
health care providers, patients, payers, and
policy makers. The Office shall also develop a
publicly available resource database that collects and contains government-funded evidence and research from public, private, notfor profit, and academic sources.
(2) Requirements
The Office shall provide for the dissemination of the Institute’s research findings and
government-funded research relevant to comparative clinical effectiveness research to physicians, health care providers, patients, vendors of health information technology focused
on clinical decision support, appropriate professional associations, and Federal and private
health plans. Materials, forums, and media
used to disseminate the findings, informational tools, and resource databases shall—
(A) include a description of considerations
for specific subpopulations, the research
methodology, and the limitations of the research, and the names of the entities, agencies, instrumentalities, and individuals who
conducted any research which was published
by the Institute; and
(B) not be construed as mandates, guidelines, or recommendations for payment, coverage, or treatment.
(b) Incorporation of research findings
The Office, in consultation with relevant medical and clinical associations, shall assist users
of health information technology focused on
clinical decision support to promote the timely
incorporation of research findings disseminated
under subsection (a) into clinical practices and
to promote the ease of use of such incorporation.
(c) Feedback
The Office shall establish a process to receive
feedback from physicians, health care providers,
patients, and vendors of health information
technology focused on clinical decision support,
appropriate professional associations, and Federal and private health plans about the value of
the information disseminated and the assistance
provided under this section.
(d) Rule of construction
Nothing in this section shall preclude the Institute from making its research findings publicly available as required under section
1320e(d)(8) of this title.
(e) Training of researchers
The Agency for Health Care Research and
Quality, in consultation with the National Institutes of Health, shall build capacity for comparative clinical effectiveness research by establishing a grant program that provides for the
training of researchers in the methods used to
conduct such research, including systematic reviews of existing research and primary research
such as clinical trials. At a minimum, such
training shall be in methods that meet the

§ 299c

methodological standards adopted under section
1320e(d)(9) of this title.
(f) Building data for research
The Secretary shall provide for the coordination of relevant Federal health programs to
build data capacity for comparative clinical effectiveness research, including the development
and use of clinical registries and health outcomes research data networks, in order to develop and maintain a comprehensive, interoperable data network to collect, link, and analyze
data on outcomes and effectiveness from multiple sources, including electronic health
records.
(g) Authority to contract with the Institute
Agencies and instrumentalities of the Federal
Government may enter into agreements with
the Institute, and accept and retain funds, for
the conduct and support of research described in
this part, provided that the research to be conducted or supported under such agreements is
authorized under the governing statutes of such
agencies and instrumentalities.
(July 1, 1944, ch. 373, title IX, § 937, as added Pub.
L. 111–148, title VI, § 6301(b), Mar. 23, 2010, 124
Stat. 738.)
PRIOR PROVISIONS
A prior section 937 of act July 1, 1944, was renumbered
section 947 and is classified to section 299c–6 of this
title.

PART E—GENERAL PROVISIONS
AMENDMENTS
2010—Pub. L. 111–148, title III, § 3013(a)(1), Mar. 23,
2010, 124 Stat. 381, redesignated part D ‘‘General Provisions’’ as E.
2005—Pub. L. 109–41, § 2(a)(2), July 29, 2005, 119 Stat.
424, redesignated part C ‘‘General Provisions’’ as D.

§ 299c. Advisory Council for Healthcare Research
and Quality
(a) Establishment
There is established an advisory council to be
known as the National Advisory Council for
Healthcare Research and Quality.
(b) Duties
(1) In general
The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the
mission of the Agency under section 299(b) of
this title.
(2) Certain recommendations
Activities of the Advisory Council under
paragraph (1) shall include making recommendations to the Director regarding—
(A) priorities regarding health care research, especially studies related to quality,
outcomes, cost and the utilization of, and
access to, health care services;
(B) the field of health care research and related disciplines, especially issues related to
training needs, and dissemination of information pertaining to health care quality;
and
(C) the appropriate role of the Agency in
each of these areas in light of private sector

§ 299c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

activity and identification of opportunities
for public-private sector partnerships.
(c) Membership
(1) In general
The Advisory Council shall, in accordance
with this subsection, be composed of appointed
members and ex officio members. All members
of the Advisory Council shall be voting members other than the individuals designated
under paragraph (3)(B) as ex officio members.
(2) Appointed members
The Secretary shall appoint to the Advisory
Council 21 appropriately qualified individuals.
At least 17 members of the Advisory Council
shall be representatives of the public who are
not officers or employees of the United States
and at least 1 member who shall be a specialist
in the rural aspects of 1 or more of the professions or fields described in subparagraphs (A)
through (G). The Secretary shall ensure that
the appointed members of the Council, as a
group, are representative of professions and
entities concerned with, or affected by, activities under this subchapter and under section
1320b–12 of this title. Of such members—
(A) three shall be individuals distinguished
in the conduct of research, demonstration
projects, and evaluations with respect to
health care;
(B) three shall be individuals distinguished
in the fields of health care quality research
or health care improvement;
(C) three shall be individuals distinguished
in the practice of medicine of which at least
one shall be a primary care practitioner;
(D) three shall be individuals distinguished
in the other health professions;
(E) three shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems;
(F) three shall be individuals distinguished
in the fields of health care economics, information systems, law, ethics, business, or
public policy; and
(G) three shall be individuals representing
the interests of patients and consumers of
health care.
(3) Ex officio members
The Secretary shall designate as ex officio
members of the Advisory Council—
(A) the Assistant Secretary for Health, the
Director of the National Institutes of
Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Commissioner of the Food
and Drug Administration, the Director of
the Office of Personnel Management, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of
the Department of Veterans Affairs; and
(B) such other Federal officials as the Secretary may consider appropriate.

Page 894

(d) Terms
(1) In general
Members of the Advisory Council appointed
under subsection (c)(2) of this section shall
serve for a term of 3 years.
(2) Staggered terms
To ensure the staggered rotation of onethird of the members of the Advisory Council
each year, the Secretary is authorized to appoint the initial members of the Advisory
Council for terms of 1, 2, or 3 years.
(3) Service beyond term
A member of the Council appointed under
subsection (c)(2) of this section may continue
to serve after the expiration of the term of the
members until a successor is appointed.
(e) Vacancies
If a member of the Advisory Council appointed
under subsection (c)(2) of this section does not
serve the full term applicable under subsection
(d) of this section, the individual appointed to
fill the resulting vacancy shall be appointed for
the remainder of the term of the predecessor of
the individual.
(f) Chair
The Director shall, from among the members
of the Advisory Council appointed under subsection (c)(2) of this section, designate an individual to serve as the chair of the Advisory
Council.
(g) Meetings
The Advisory Council shall meet not less than
once during each discrete 4-month period and
shall otherwise meet at the call of the Director
or the chair.
(h) Compensation and reimbursement of expenses
(1) Appointed members
Members of the Advisory Council appointed
under subsection (c)(2) of this section shall receive compensation for each day (including
travel time) engaged in carrying out the duties of the Advisory Council unless declined by
the member. Such compensation may not be
in an amount in excess of the daily equivalent
of the annual rate of basic pay prescribed for
level IV of the Executive Schedule under section 5315 of title 5 for each day during which
such member is engaged in the performance of
the duties of the Advisory Council.
(2) Ex officio members
Officials designated under subsection (c)(3)
of this section as ex officio members of the Advisory Council may not receive compensation
for service on the Advisory Council in addition
to the compensation otherwise received for duties carried out as officers of the United
States.
(i) Staff
The Director shall provide to the Advisory
Council such staff, information, and other assistance as may be necessary to carry out the
duties of the Council.
(j) Duration
Notwithstanding section 14(a) of the Federal
Advisory Committee Act, the Advisory Council

Page 895

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall continue in existence until otherwise provided by law.
(July 1, 1944, ch. 373, title IX, § 941, formerly § 921,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1663; amended Pub. L. 108–173, title IX,
§ 900(e)(2)(D), Dec. 8, 2003, 117 Stat. 2372; renumbered § 931, Pub. L. 109–41, § 2(a)(3), July 29, 2005,
119 Stat. 424; renumbered § 941, Pub. L. 111–148,
title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
REFERENCES IN TEXT
Section 14(a) of the Federal Advisory Committee Act,
referred to in subsec. (j), is section 14(a) of Pub. L.
92–463, which is set out in the Appendix to Title 5.
PRIOR PROVISIONS
A prior section 299c, act July 1, 1944, ch. 373, title IX,
§ 921, as added Pub. L. 101–239, title VI, § 6103(c), Dec. 19,
1989, 103 Stat. 2199; amended Pub. L. 102–410, § 8, Oct. 13,
1992, 106 Stat. 2100, established the Advisory Council for
Health Care Policy, Research, and Evaluation, prior to
the general amendment of this subchapter by Pub. L.
106–129.
Another prior section 299c, act July 1, 1944, ch. 373,
title IX, § 903, as added Oct. 6, 1965, Pub. L. 89–239, § 2,
79 Stat. 927; amended Oct. 15, 1968, Pub. L. 90–574, title
I, § 104, 82 Stat. 1005; Oct. 30, 1970, Pub. L. 91–515, title
I, §§ 105, 111(b), 84 Stat. 1299, 1301, authorized Secretary
to make planning grants and set forth requirements for
grant applications, prior to repeal by Pub. L. 99–117,
§ 12(d), Oct. 7, 1985, 99 Stat. 495.
AMENDMENTS
2003—Subsec. (c)(3)(A). Pub. L. 108–173 substituted
‘‘Centers for Medicare & Medicaid Services’’ for
‘‘Health Care Financing Administration’’.

§ 299c–1. Peer review with respect to grants and
contracts
(a) Requirement of review
(1) In general
Appropriate technical and scientific peer review shall be conducted with respect to each
application for a grant, cooperative agreement, or contract under this subchapter.
(2) Reports to Director
Each peer review group to which an application is submitted pursuant to paragraph (1)
shall report its finding and recommendations
respecting the application to the Director in
such form and in such manner as the Director
shall require.
(b) Approval as precondition of awards
The Director may not approve an application
described in subsection (a)(1) of this section unless the application is recommended for approval by a peer review group established under
subsection (c) of this section.
(c) Establishment of peer review groups
(1) In general
The Director shall establish such technical
and scientific peer review groups as may be
necessary to carry out this section. Such
groups shall be established without regard to
the provisions of title 5 that govern appointments in the competitive service, and without
regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the
General Schedule.

§ 299c–1

(2) Membership
The members of any peer review group established under this section shall be appointed
from among individuals who by virtue of their
training or experience are eminently qualified
to carry out the duties of such peer review
group. Officers and employees of the United
States may not constitute more than 25 percent of the membership of any such group.
Such officers and employees may not receive
compensation for service on such groups in addition to the compensation otherwise received
for these duties carried out as such officers
and employees.
(3) Duration
Notwithstanding section 14(a) of the Federal
Advisory Committee Act, peer review groups
established under this section may continue in
existence until otherwise provided by law.
(4) Qualifications
Members of any peer review group shall, at
a minimum, meet the following requirements:
(A) Such members shall agree in writing to
treat information received, pursuant to
their work for the group, as confidential information, except that this subparagraph
shall not apply to public records and public
information.
(B) Such members shall agree in writing to
recuse themselves from participation in the
peer review of specific applications which
present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial
or other arrangement that might introduce
bias in the process of peer review.
(d) Authority for procedural adjustments in certain cases
In the case of applications for financial assistance whose direct costs will not exceed $100,000,
the Director may make appropriate adjustments
in the procedures otherwise established by the
Director for the conduct of peer review under
this section. Such adjustments may be made for
the purpose of encouraging the entry of individuals into the field of research, for the purpose of
encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate.
(e) Regulations
The Director shall issue regulations for the
conduct of peer review under this section.
(July 1, 1944, ch. 373, title IX, § 942, formerly § 922,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1665; renumbered § 932, Pub. L. 109–41,
§ 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered
§ 942, Pub. L. 111–148, title III, § 3013(a)(2), Mar.
23, 2010, 124 Stat. 381.)
REFERENCES IN TEXT
The provisions of title 5 that govern appointments in
the competitive service, referred to in subsec. (c)(1), are
classified generally to section 3301 et seq. of Title 5,
Government Organization and Employees.
Section 14(a) of the Federal Advisory Committee Act,
referred to in subsec. (c)(3), is section 14(a) of Pub. L.
92–463, which is set out in the Appendix to Title 5.

§ 299c–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 299c–1, act July 1, 1944, ch. 373, title
IX, § 922, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2201; amended Pub. L. 101–508, title IV,
§ 4118(f)(2)(F), Nov. 5, 1990, 104 Stat. 1388–70; Pub. L.
102–410, § 5(d), Oct. 13, 1992, 106 Stat. 2098, related to peer
review with respect to grants and contracts, prior to
the general amendment of this subchapter by Pub. L.
106–129.

§ 299c–2. Certain provisions with respect to development, collection, and dissemination of
data
(a) Standards with respect to utility of data
(1) In general
To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency
for the purpose described in section 299(b) of
this title, the Director shall establish standard methods for developing and collecting
such data, taking into consideration—
(A) other Federal health data collection
standards; and
(B) the differences between types of health
care plans, delivery systems, health care
providers, and provider arrangements.
(2) Relationship with other Department programs
In any case where standards under paragraph (1) may affect the administration of
other programs carried out by the Department
of Health and Human Services, including the
programs under title XVIII, XIX or XXI of the
Social Security Act [42 U.S.C. 1395 et seq., 1396
et seq., 1397aa et seq.], or may affect health information that is subject to a standard developed under part C of title XI of the Social Security Act [42 U.S.C. 1320d et seq.], they shall
be in the form of recommendations to the Secretary for such program.
(b) Statistics and analyses
The Director shall—
(1) take appropriate action to ensure that
statistics and analyses developed under this
subchapter are of high quality, timely, and
duly comprehensive, and that the statistics
are specific, standardized, and adequately analyzed and indexed; and
(2) publish, make available, and disseminate
such statistics and analyses on as wide a basis
as is practicable.
(c) Authority regarding certain requests
Upon request of a public or private entity, the
Director may conduct or support research or
analyses otherwise authorized by this subchapter pursuant to arrangements under which
such entity will pay the cost of the services provided. Amounts received by the Director under
such arrangements shall be available to the Director for obligation until expended.
(July 1, 1944, ch. 373, title IX, § 943, formerly § 923,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1666; renumbered § 933, Pub. L. 109–41,
§ 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered
§ 943, Pub. L. 111–148, title III, § 3013(a)(2), Mar.
23, 2010, 124 Stat. 381.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (a)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Part C of title

Page 896

XI of the Act is classified generally to part C (§ 1320d et
seq.) of title XI of chapter 7 of this title. Titles XVIII,
XIX, and XXI of the Act are classified generally to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.), and
XXI (§ 1397aa et seq.), respectively, of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 299c–2, act July 1, 1944, ch. 373, title
IX, § 923, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2202; amended Pub. L. 102–410, § 5(e),
Oct. 12, 1992, 106 Stat. 2098, related to development, collection, and dissemination of data, prior to the general
amendment of this subchapter by Pub. L. 106–129.

§ 299c–3. Dissemination of information
(a) In general
The Director shall—
(1) without regard to section 501 of title 44,
promptly publish, make available, and otherwise disseminate, in a form understandable
and on as broad a basis as practicable so as to
maximize its use, the results of research, demonstration projects, and evaluations conducted or supported under this subchapter;
(2) ensure that information disseminated by
the Agency is science-based and objective and
undertakes consultation as necessary to assess
the appropriateness and usefulness of the presentation of information that is targeted to
specific audiences;
(3) promptly make available to the public
data developed in such research, demonstration projects, and evaluations;
(4) provide, in collaboration with the National Library of Medicine where appropriate,
indexing, abstracting, translating, publishing,
and other services leading to a more effective
and timely dissemination of information on
research, demonstration projects, and evaluations with respect to health care to public and
private entities and individuals engaged in the
improvement of health care delivery and the
general public, and undertake programs to develop new or improved methods for making
such information available; and
(5) as appropriate, provide technical assistance to State and local government and health
agencies and conduct liaison activities to such
agencies to foster dissemination.
(b) Prohibition against restrictions
Except as provided in subsection (c) of this
section, the Director may not restrict the publication or dissemination of data from, or the results of, projects conducted or supported under
this subchapter.
(c) Limitation on use of certain information
No information, if an establishment or person
supplying the information or described in it is
identifiable, obtained in the course of activities
undertaken or supported under this subchapter
may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined
under regulations of the Director) to its use for
such other purpose. Such information may not
be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person

Page 897

TITLE 42—THE PUBLIC HEALTH AND WELFARE

has consented (as determined under regulations
of the Director) to its publication or release in
other form.
(d) Penalty
Any person who violates subsection (c) of this
section shall be subject to a civil monetary penalty of not more than $10,000 for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money
penalties under subsection (a) of section 1320a–7a
of this title are imposed and collected.
(July 1, 1944, ch. 373, title IX, § 944, formerly § 924,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1667; renumbered § 934, Pub. L. 109–41,
§ 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered
§ 944, Pub. L. 111–148, title III, § 3013(a)(2), Mar.
23, 2010, 124 Stat. 381.)
PRIOR PROVISIONS
A prior section 299c–3, act July 1, 1944, ch. 373, title
IX, § 924, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2202; amended Pub. L. 102–410, § 9, Oct.
13, 1992, 106 Stat. 2100, related to additional provisions
with respect to grants and contracts, prior to the general amendment of this subchapter by Pub. L. 106–129.
See section 299c–4 of this title.

§ 299c–4. Additional provisions with respect to
grants and contracts
(a) Financial conflicts of interest
With respect to projects for which awards of
grants, cooperative agreements, or contracts are
authorized to be made under this subchapter,
the Director shall by regulation define—
(1) the specific circumstances that constitute financial interests in such projects
that will, or may be reasonably expected to,
create a bias in favor of obtaining results in
the projects that are consistent with such interests; and
(2) the actions that will be taken by the Director in response to any such interests identified by the Director.
(b) Requirement of application
The Director may not, with respect to any
program under this subchapter authorizing the
provision of grants, cooperative agreements, or
contracts, provide any such financial assistance
unless an application for the assistance is submitted to the Secretary and the application is in
such form, is made in such manner, and contains
such agreements, assurances, and information
as the Director determines to be necessary to
carry out the program involved.
(c) Provision of supplies and services in lieu of
funds
(1) In general
Upon the request of an entity receiving a
grant, cooperative agreement, or contract
under this subchapter, the Secretary may,
subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding the entity in carrying out the project involved and, for such purpose, may detail to the
entity any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in funds
With respect to a request described in paragraph (1), the Secretary shall reduce the

§ 299c–5

amount of the financial assistance involved by
an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the
Director. The Secretary shall, for the payment
of expenses incurred in complying with such
request, expend the amounts withheld.
(d) Applicability of certain provisions with respect to contracts
Contracts may be entered into under this part
without regard to section 3324(a) and (b) of title
31 and section 6101 of title 41.
(July 1, 1944, ch. 373, title IX, § 945, formerly § 925,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1668; renumbered § 935, Pub. L. 109–41,
§ 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered
§ 945, Pub. L. 111–148, title III, § 3013(a)(2), Mar.
23, 2010, 124 Stat. 381.)
CODIFICATION
In subsec. (d), ‘‘section 3324(a) and (b) of title 31 and
section 6101 of title 41’’ substituted for ‘‘sections 3648
and 3709 of the Revised Statutes (31 U.S.C. 529 and 41
U.S.C. 5)’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13,
1982, 96 Stat. 1067, which Act enacted Title 31, Money
and Finance, and Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
PRIOR PROVISIONS
A prior section 299c–4, act July 1, 1944, ch. 373, title
IX, § 925, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2203; amended Pub. L. 104–201, div. A,
title XVII, § 1723(a)(3)(B), Sept. 23, 1996, 110 Stat. 2759,
related to certain administrative authorities, prior to
the general amendment of this subchapter by Pub. L.
106–129. See section 299c–5 of this title.

§ 299c–5. Certain administrative authorities
(a) Deputy director and other officers and employees
(1) Deputy director
The Director may appoint a deputy director
for the Agency.
(2) Other officers and employees
The Director may appoint and fix the compensation of such officers and employees as
may be necessary to carry out this subchapter.
Except as otherwise provided by law, such officers and employees shall be appointed in accordance with the civil service laws and their
compensation fixed in accordance with title 5.
(b) Facilities
The Secretary, in carrying out this subchapter—
(1) may acquire, without regard to section
8141 of title 40, by lease or otherwise through
the Administrator of General Services, buildings or portions of buildings in the District of
Columbia or communities located adjacent to
the District of Columbia for use for a period
not to exceed 10 years; and
(2) may acquire, construct, improve, repair,
operate, and maintain laboratory, research,
and other necessary facilities and equipment,
and such other real or personal property (including patents) as the Secretary deems necessary.
(c) Provision of financial assistance
The Director, in carrying out this subchapter,
may make grants to public and nonprofit enti-

§ 299c–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ties and individuals, and may enter into cooperative agreements or contracts with public and
private entities and individuals.
(d) Utilization of certain personnel and resources
(1) Department of Health and Human Services
The Director, in carrying out this subchapter, may utilize personnel and equipment,
facilities, and other physical resources of the
Department of Health and Human Services,
permit appropriate (as determined by the Secretary) entities and individuals to utilize the
physical resources of such Department, and
provide technical assistance and advice.
(2) Other agencies
The Director, in carrying out this subchapter, may use, with their consent, the services, equipment, personnel, information, and
facilities of other Federal, State, or local public agencies, or of any foreign government,
with or without reimbursement of such agencies.
(e) Consultants
The Secretary, in carrying out this subchapter, may secure, from time to time and for
such periods as the Director deems advisable but
in accordance with section 3109 of title 5, the assistance and advice of consultants from the
United States or abroad.
(f) Experts
(1) In general
The Secretary may, in carrying out this subchapter, obtain the services of not more than
50 experts or consultants who have appropriate
scientific or professional qualifications. Such
experts or consultants shall be obtained in accordance with section 3109 of title 5, except
that the limitation in such section on the duration of service shall not apply.
(2) Travel expenses
(A) In general
Experts and consultants whose services are
obtained under paragraph (1) shall be paid or
reimbursed for their expenses associated
with traveling to and from their assignment
location in accordance with sections 5724,
5724a(a), 5724a(c), and 5726(c) of title 5.
(B) Limitation
Expenses specified in subparagraph (A)
may not be allowed in connection with the
assignment of an expert or consultant whose
services are obtained under paragraph (1) unless and until the expert agrees in writing to
complete the entire period of assignment, or
1 year, whichever is shorter, unless separated or reassigned for reasons that are beyond the control of the expert or consultant
and that are acceptable to the Secretary. If
the expert or consultant violates the agreement, the money spent by the United States
for the expenses specified in subparagraph
(A) is recoverable from the expert or consultant as a statutory obligation owed to the
United States. The Secretary may waive in
whole or in part a right of recovery under
this subparagraph.

Page 898

(g) Voluntary and uncompensated services
The Director, in carrying out this subchapter,
may accept voluntary and uncompensated services.
(July 1, 1944, ch. 373, title IX, § 946, formerly § 926,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1668; renumbered § 936, Pub. L. 109–41,
§ 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered
§ 946, Pub. L. 111–148, title III, § 3013(a)(2), Mar.
23, 2010, 124 Stat. 381.)
CODIFICATION
In subsec. (b)(1), ‘‘section 8141 of title 40’’ substituted
for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303,
the first section of which enacted Title 40, Public
Buildings, Property, and Works.
PRIOR PROVISIONS
A prior section 299c–5, act July 1, 1944, ch. 373, title
IX, § 926, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2204; amended Pub. L. 101–381, title I,
§ 102(7), Aug. 18, 1990, 104 Stat. 586; Pub. L. 102–410, § 10,
Oct. 13, 1992, 106 Stat. 2101; Pub. L. 103–43, title XX,
§ 2010(b)(8), June 10, 1993, 107 Stat. 214, authorized appropriations to carry out this subchapter, prior to the general amendment of this subchapter by Pub. L. 106–129.
See section 299c–6 of this title.

§ 299c–6. Funding
(a) Intent
To ensure that the United States investment
in biomedical research is rapidly translated into
improvements in the quality of patient care,
there must be a corresponding investment in research on the most effective clinical and organizational strategies for use of these findings in
daily practice. The authorization levels in subsections (b) and (c) of this section provide for a
proportionate increase in health care research
as the United States investment in biomedical
research increases.
(b) Authorization of appropriations
For the purpose of carrying out this subchapter, there are authorized to be appropriated
$250,000,000 for fiscal year 2000, and such sums as
may be necessary for each of the fiscal years
2001 through 2005.
(c) Evaluations
In addition to amounts available pursuant to
subsection (b) of this section for carrying out
this subchapter, there shall be made available
for such purpose, from the amounts made available pursuant to section 238j of this title (relating to evaluations), an amount equal to 40 percent of the maximum amount authorized in such
section 238j of this title to be made available for
a fiscal year.
(d) Health disparities research
For the purpose of carrying out the activities
under section 299a–1 of this title, there are authorized to be appropriated $50,000,000 for fiscal
year 2001, and such sums as may be necessary for
each of the fiscal years 2002 through 2005.
(e) Patient safety and quality improvement
For the purpose of carrying out part C of this
subchapter, there are authorized to be appropriated such sums as may be necessary for each
of the fiscal years 2006 through 2010.

Page 899

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title IX, § 947, formerly § 927,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1670; amended Pub. L. 106–525, title II,
§ 201(b), Nov. 22, 2000, 114 Stat. 2507; renumbered
§ 937 and amended Pub. L. 109–41, § 2(a)(3), (b),
July 29, 2005, 119 Stat. 424, 434; renumbered § 947,
Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010,
124 Stat. 381.)
PRIOR PROVISIONS
A prior section 299c–6, act July 1, 1944, ch. 373, title
IX, § 927, as added Pub. L. 101–239, title VI, § 6103(c), Dec.
19, 1989, 103 Stat. 2204, set out definitions, prior to the
general amendment of this subchapter by Pub. L.
106–129. See section 299c–7 of this title.
AMENDMENTS
2005—Subsec. (e). Pub. L. 109–41, § 2(b), added subsec.
(e).
2000—Subsec. (d). Pub. L. 106–525 added subsec. (d).

§ 299c–7. Definitions
In this subchapter:
(1) Advisory Council
The term ‘‘Advisory Council’’ means the National Advisory Council on Healthcare Research and Quality established under section
299c of this title.
(2) Agency
The term ‘‘Agency’’ means the Agency for
Healthcare Research and Quality.
(3) Director
The term ‘‘Director’’ means the Director of
the Agency for Healthcare Research and Quality.
(July 1, 1944, ch. 373, title IX, § 948, formerly § 928,
as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113
Stat. 1670; renumbered § 938 and amended Pub. L.
109–41, § 2(a)(3), (4), July 29, 2005, 119 Stat. 424; renumbered § 948 and amended Pub. L. 111–148, title
III, § 3013(a)(2), (3), Mar. 23, 2010, 124 Stat. 381.)
PRIOR PROVISIONS
Prior sections 299d to 299j were repealed by Pub. L.
99–117, § 12(d), Oct. 7, 1985, 99 Stat. 495.
Section 299d, act July 1, 1944, ch. 373, title IX, § 904, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 928;
amended Oct. 15, 1968, Pub. L. 90–574, title I, § 104, 82
Stat. 1005; Oct. 30, 1970, Pub. L. 91–515, title I, §§ 106,
111(b), 84 Stat. 1299, 1301, authorized Secretary to make
grants for establishment and operation of regional
medical programs and set forth requirements for grant
applications.
Section 299e, act July 1, 1944, ch. 373, title IX, § 905, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 929;
amended Oct. 15, 1968, Pub. L. 90–574, title I, § 105, 82
Stat. 1005; Oct. 30, 1970, Pub. L. 91–515, title I, §§ 107(a),
111(b), title VI, § 601(b)(2), (4), 84 Stat. 1299, 1301, 1311;
Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93 Stat. 695,
provided for establishment of a National Advisory
Council on Regional Medical Programs and its functions.
Section 299f, act July 1, 1944, ch. 373, title IX, § 906, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 930;
amended Oct. 30, 1970, Pub. L. 91–515, title I, § 111(b), 84
Stat. 1301, authorized Secretary to establish rules and
regulations covering terms of approval of grant applications and coordination of programs.
Section 299g, act July 1, 1944, ch. 373, title IX, § 907, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 930;
amended Oct. 30, 1970, Pub. L. 91–515, title I, §§ 108,
111(b), 84 Stat. 1300, 1301, directed Secretary to compile

§ 300

a list of facilities equipped and staffed to provide most
advanced methods for diagnosing and treating certain
diseases and illnesses.
Section 299h, act July 1, 1944, ch. 373, title IX, § 908, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 930, called
for a report to the President and the Congress on or before June 30, 1967, by Surgeon General concerning activities under this subchapter with required statements, appraisals, and recommendations.
Section 299i, act July 1, 1944, ch. 373, title IX, § 909, as
added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 930;
amended Oct. 30, 1970, Pub. L. 91–515, title I, §§ 109,
111(b), 84 Stat. 1300, 1301; Oct. 17, 1979, Pub. L. 96–88,
title V, § 509(b), 93 Stat. 695, provided for recordkeeping
by grant recipients and for accessibility of records for
audit and examination.
Section 299j, act July 1, 1944, ch. 373, title IX, § 910, as
added Oct. 15, 1968, Pub. L. 90–574, title I, § 106, 82 Stat.
1005; amended Oct. 30, 1970, Pub. L. 91–515, title I, § 110,
84 Stat. 1300, related to grants and contracts for multiprogram services, costs of special projects, and support
of research, studies, investigations, training, and demonstrations.
AMENDMENTS
2010—Par. (1). Pub. L. 111–148, § 3013(a)(3), made technical amendment to reference in original act which appears in text as reference to section 299c of this title,
requiring no change in text.
2005—Par. (1). Pub. L. 109–41, § 2(a)(4), made technical
amendment to reference in original act which appears
in text as reference to section 299c of this title, requiring no change in text.

SUBCHAPTER
VIII—POPULATION
RESEARCH AND VOLUNTARY FAMILY PLANNING PROGRAMS
§ 300. Project grants and contracts for family
planning services
(a) Authority of Secretary
The Secretary is authorized to make grants to
and enter into contracts with public or nonprofit private entities to assist in the establishment and operation of voluntary family planning projects which shall offer a broad range of
acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services
for adolescents). To the extent practical, entities which receive grants or contracts under this
subsection shall encourage familiy 1 participation in projects assisted under this subsection.
(b) Factors determining awards; establishment
and preservation of rights of local and regional entities
In making grants and contracts under this section the Secretary shall take into account the
number of patients to be served, the extent to
which family planning services are needed locally, the relative need of the applicant, and its
capacity to make rapid and effective use of such
assistance. Local and regional entities shall be
assured the right to apply for direct grants and
contracts under this section, and the Secretary
shall by regulation fully provide for and protect
such right.
(c) Reduction of grant amount
The Secretary, at the request of a recipient of
a grant under subsection (a) of this section, may
reduce the amount of such grant by the fair
1 So

in original. Probably should be ‘‘family’’.

§ 300

TITLE 42—THE PUBLIC HEALTH AND WELFARE

market value of any supplies or equipment furnished the grant recipient by the Secretary. The
amount by which any such grant is so reduced
shall be available for payment by the Secretary
of the costs incurred in furnishing the supplies
or equipment on which the reduction of such
grant is based. Such amount shall be deemed as
part of the grant and shall be deemed to have
been paid to the grant recipient.
(d) Authorization of appropriations
For the purpose of making grants and contracts under this section, there are authorized
to be appropriated $30,000,000 for the fiscal year
ending June 30, 1971; $60,000,000 for the fiscal
year ending June 30, 1972; $111,500,000 for the fiscal year ending June 30, 1973, $111,500,000 each
for the fiscal years ending June 30, 1974, and
June 30, 1975; $115,000,000 for fiscal year 1976;
$115,000,000 for the fiscal year ending September
30, 1977; $136,400,000 for the fiscal year ending
September 30, 1978; $200,000,000 for the fiscal year
ending September 30, 1979; $230,000,000 for the fiscal year ending September 30, 1980; $264,500,000
for the fiscal year ending September 30, 1981;
$126,510,000 for the fiscal year ending September
30, 1982; $139,200,000 for the fiscal year ending
September 30, 1983; $150,830,000 for the fiscal year
ending September 30, 1984; and $158,400,000 for
the fiscal year ending September 30, 1985.
(July 1, 1944, ch. 373, title X, § 1001, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1506;
amended Pub. L. 92–449, title III, § 301, Sept. 30,
1972, 86 Stat. 754; Pub. L. 93–45, title I, § 111(a),
June 18, 1973, 87 Stat. 93; Pub. L. 94–63, title II,
§§ 202(a), 204(a), (b), title VII, § 701(d), July 29,
1975, 89 Stat. 306–308, 352; Pub. L. 95–83, title III,
§ 305(a), Aug. 1, 1977, 91 Stat. 388; Pub. L. 95–613,
§ 1(a)(1), (b)(1), Nov. 8, 1978, 92 Stat. 3093; Pub. L
97–35, title IX, § 931(a)(1), (b)(1), Aug. 13, 1981, 95
Stat. 570; Pub. L. 97–414, §§ 8(n), 9(a), Jan. 4, 1983,
96 Stat. 2061, 2064; Pub. L. 98–512, § 3(a), Oct. 19,
1984, 98 Stat. 2409; Pub. L. 98–555, § 9, Oct. 30, 1984,
98 Stat. 2857.)
AMENDMENTS
1984—Subsec. (c). Pub. L. 98–555 added subsec. (c).
Former subsec. (c) redesignated (d).
Pub. L. 98–512 inserted provisions authorizing appropriations for the fiscal year ending Sept. 30, 1985.
Subsec. (d). Pub. L. 98–555 redesignated former subsec.
(c) as (d).
1983—Subsec. (c). Pub. L. 97–414, § 8(n), substituted a
semicolon for a comma after ‘‘1981’’.
Pub. L. 97–414, § 9(a), amended directory language of
Pub. L. 97–35, § 931(a)(1), to correct a typographical
error and did not involve any change in text. See 1981
Amendment note below.
1981—Subsec. (a). Pub. L. 97–35, § 931(b)(1), inserted
provisions relating to family participation in projects.
Subsec. (c). Pub. L. 97–35, § 931(a)(1), as amended by
Pub. L. 97–414, § 9(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983,
and 1984.
1978—Subsec. (a). Pub. L. 95–613, § 1(a)(1), inserted provisions relating to infertility services and services for
adolescents.
Subsec. (c). Pub. L. 95–613, § 1(b)(1), inserted provisions authorizing appropriations for fiscal years ending
Sept. 30, 1979, 1980, and 1981.
1977—Subsec. (c). Pub. L. 95–83 substituted provision
authorizing appropriations for fiscal years ending Sept.
30, 1977 and 1978, for prior such authorization for fiscal
year 1977.

Page 900

1975—Subsec. (a). Pub. L. 94–63, § 204(a), inserted provision relating to scope of family planning projects to
be offered.
Subsec. (b). Pub. L. 94–63, § 204(b), inserted provision
relating to direct grants and contracts for local and regional entities.
Subsec. (c). Pub. L. 94–63, §§ 202(a), 701(d), inserted
provisions authorizing appropriations for fiscal years
ending June 30, 1975, 1976, and 1977.
1973—Subsec. (c). Pub. L. 93–45 inserted provisions authorizing appropriations for fiscal year ending June 30,
1974.
1972—Subsec. (c). Pub. L. 92–449 increased appropriations authorization for fiscal year ending June 30, 1973,
to $111,500,000 from $90,000,000.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by sections 202(a) and 204(a), (b) of Pub.
L. 94–63 effective July 1, 1975, see section 608 of Pub. L.
94–63, set out as a note under section 247b of this title.
STUDY AS TO DISCRIMINATION BY SCHOOLS OF MEDICINE, NURSING, OR OSTEOPATHY AGAINST APPLICANTS
BECAUSE OF RELUCTANCE OR WILLINGNESS TO PARTICIPATE IN ABORTIONS OR STERILIZATIONS; REPORT
NOT LATER THAN FEBRUARY 1, 1978
Pub. L. 95–215, § 7, Dec. 19, 1977, 91 Stat. 1507, required
Secretary of Health, Education, and Welfare to conduct
a study and report to specific committees of Congress
not later than Feb. 1, 1978, as to whether schools of
medicine, nursing, or osteopathy discriminate against
applicants because of applicant’s reluctance or unwillingness to participate in performance of abortions or
sterilizations contrary to religious beliefs or moral
convictions.
CONGRESSIONAL DECLARATION OF PURPOSE
Section 2 of Pub. L. 91–572 provided that: ‘‘It is the
purpose of this Act [see Short Title of 1970 Amendment
note set out under section 201 of this title]—
‘‘(1) to assist in making comprehensive voluntary
family planning services readily available to all persons desiring such services;
‘‘(2) to coordinate domestic population and family
planning research with the present and future needs
of family planning programs;
‘‘(3) to improve administrative and operational supervision of domestic family planning services and of
population research programs related to such services;
‘‘(4) to enable public and nonprofit private entities
to plan and develop comprehensive programs of family planning services;
‘‘(5) to develop and make readily available information (including educational materials) on family
planning and population growth to all persons desiring such information;
‘‘(6) to evaluate and improve the effectiveness of
family planning service programs and of population
research;
‘‘(7) to assist in providing trained manpower needed
to effectively carry out programs of population research and family planning services; and
‘‘(8) to establish an Office of Population Affairs in
the Department of Health, Education, and Welfare as
a primary focus within the Federal Government on
matters pertaining to population research and family
planning, through which the Secretary of Health,
Education, and Welfare [now Health and Human Services] (hereafter in this Act referred to as the ‘Secretary’) shall carry out the purposes of this Act.’’
THE TITLE X ‘‘GAG RULE’’
Memorandum of President of the United States, Jan.
22, 1993, 58 F.R. 7455, provided:
Memorandum for the Secretary of Health and Human
Services
Title X of the Public Health Services Act [42 U.S.C.
300 et seq.] provides Federal funding for family plan-

Page 901

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ning clinics to provide services for low-income patients. The Act specifies that Title X funds may not be
used for the performance of abortions, but places no restrictions on the ability of clinics that receive Title X
funds to provide abortion counseling and referrals or to
perform abortions using non-Title X funds. During the
first 18 years of the program, medical professionals at
Title X clinics provided complete, uncensored information, including nondirective abortion counseling. In
February 1988, the Department of Health and Human
Services adopted regulations, which have become
known as the ‘‘Gag Rule,’’ prohibiting Title X recipients from providing their patients with information,
counseling, or referrals concerning abortion. Subsequent attempts by the Bush Administration to modify
the Gag Rule and ensuing litigation have created confusion and uncertainty about the current legal status
of the regulations.
The Gag Rule endangers women’s lives and health by
preventing them from receiving complete and accurate
medical information and interferes with the doctor-patient relationship by prohibiting information that medical professionals are otherwise ethically and legally
required to provide to their patients. Furthermore, the
Gag Rule contravenes the clear intent of a majority of
the members of both the United States Senate and
House of Representatives, which twice passed legislation to block the Gag Rule’s enforcement but failed to
override Presidential vetoes.
For these reasons, you have informed me that you
will suspend the Gag Rule pending the promulgation of
new regulations in accordance with the ‘‘notice and
comment’’ procedures of the Administrative Procedure
Act [5 U.S.C. 551 et seq.]. I hereby direct you to take
that action as soon as possible. I further direct that,
within 30 days, you publish in the Federal Register new
proposed regulations for public comment.
You are hereby authorized and directed to publish
this memorandum in the Federal Register.
WILLIAM J. CLINTON.

§ 300a. Formula grants to States for family planning services
(a) Authority of Secretary; prerequisites
The Secretary is authorized to make grants,
from allotments made under subsection (b) of
this section, to State health authorities to assist in planning, establishing, maintaining, coordinating, and evaluating family planning services. No grant may be made to a State health
authority under this section unless such authority has submitted, and had approved by the Secretary, a State plan for a coordinated and comprehensive program of family planning services.
(b) Factors determining amount of State allotments
The sums appropriated to carry out the provisions of this section shall be allotted to the
States by the Secretary on the basis of the population and the financial need of the respective
States.
(c) ‘‘State’’ defined
For the purposes of this section, the term
‘‘State’’ includes the Commonwealth of Puerto
Rico, the Northern Mariana Islands, Guam,
American Samoa, the Virgin Islands, the District of Columbia, and the Trust Territory of the
Pacific Islands.
(d) Authorization of appropriations
For the purpose of making grants under this
section, there are authorized to be appropriated
$10,000,000 for the fiscal year ending June 30,
1971; $15,000,000 for the fiscal year ending June

§ 300a–1

30, 1972; and $20,000,000 for the fiscal year ending
June 30, 1973.
(July 1, 1944, ch. 373, title X, § 1002, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1506;
amended Pub. L. 94–484, title IX, § 905(b)(1), Oct.
12, 1976, 90 Stat. 2325.)
AMENDMENTS
1976—Subsec. (c). Pub. L. 94–484 defined ‘‘State’’ to include Northern Mariana Islands.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
STUDY OF STATE DELIVERY OF SERVICES; REPORT TO
CONGRESS
Pub. L. 97–35, title IX, § 931(c), Aug. 13, 1981, 95 Stat.
570, directed Secretary of Health and Human Services
to conduct a study of possible ways of State delivery of
services for which assistance is authorized by title X of
the Public Health Service Act [this subchapter] and to
report to Congress on results of such study 18 months
after Aug. 13, 1981.

§ 300a–1. Training grants and contracts; authorization of appropriations
(a) The Secretary is authorized to make
grants to public or nonprofit private entities
and to enter into contracts with public or private entities and individuals to provide the
training for personnel to carry out family planning service programs described in section 300 or
300a of this title.
(b) For the purpose of making payments pursuant to grants and contracts under this section, there are authorized to be appropriated
$2,000,000 for the fiscal year ending June 30, 1971;
$3,000,000 for the fiscal year ending June 30, 1972;
$4,000,000 for the fiscal year ending June 30, 1973;
$3,000,000 each for the fiscal years ending June
30, 1974 and June 30, 1975; $4,000,000 for fiscal year
ending 1976; $5,000,000 for the fiscal year ending
September 30, 1977; $3,000,000 for the fiscal year
ending September 30, 1978; $3,100,000 for the fiscal year ending September 30, 1979; $3,600,000 for
the fiscal year ending September 30, 1980;
$4,100,000 for the fiscal year ending September
30, 1981; $2,920,000 for the fiscal year ending September 30, 1982; $3,200,000 for the fiscal year ending September 30, 1983; $3,500,000 for the fiscal
year ending September 30, 1984; and $3,500,000 for
the fiscal year ending September 30, 1985.
(July 1, 1944, ch. 373, title X, § 1003, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1507;
amended Pub. L. 93–45, title I, § 111(b), June 18,
1973, 87 Stat. 93; Pub. L. 94–63, title II, § 202(b),
title VII, § 701(d), July 29, 1975, 89 Stat. 306, 352;
Pub. L. 95–83, title III, § 305(b), Aug. 1, 1977, 91
Stat. 389; Pub. L. 95–613, § 1(b)(2), Nov. 8, 1978, 92
Stat. 3093; Pub. L. 97–35, title IX, § 931(a)(2), Aug.
13, 1981, 95 Stat. 570; Pub. L. 97–414, §§ 8(n), 9(a),
Jan. 4, 1983, 96 Stat. 2061, 2064; Pub. L. 98–512,
§ 3(b), Oct. 19, 1984, 98 Stat. 2410.)
AMENDMENTS
1984—Subsec. (b). Pub. L. 98–512 inserted provisions
authorizing appropriations for fiscal year ending Sept.
30, 1985.
1983—Subsec. (b). Pub. L. 97–414, § 8(n), substituted a
semicolon for a comma after ‘‘1981’’.

§ 300a–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 97–414, § 9(a), amended directory language of
Pub. L. 97–35, § 931(a)(2), to correct a typographical
error and did not involve any change in text. See 1981
Amendment note below.
1981—Subsec. (b). Pub. L. 97–35, as amended by Pub. L.
97–414, § 9(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and
1984.
1978—Subsec. (b). Pub. L. 95–613 inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1979, 1980, and 1981.
1977—Subsec. (b). Pub. L. 95–83 substituted provision
authorizing appropriations for fiscal years ending Sept.
30, 1977 and 1978, for prior such authorization for fiscal
year 1977.
1975—Subsec. (b). Pub. L. 94–63 inserted provisions authorizing appropriations for fiscal years ending June 30,
1975, 1976, and 1977.
1973—Subsec. (b). Pub. L. 93–45 inserted provisions authorizing appropriations for fiscal year ending June 30,
1974.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by section 202(b) of Pub. L. 94–63 effective July 1, 1975, see section 608 of Pub. L. 94–63, set out
as a note under section 247b of this title.

§ 300a–2. Conduct, etc., of research activities
The Secretary may—
(1) conduct, and
(2) make grants to public or nonprofit private entities and enter into contracts with
public or private entities and individuals for
projects for,
research in the biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population.
(July 1, 1944, ch. 373, title X, § 1004, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1507;
amended Pub. L. 93–45, title I, § 111(c), June 18,
1973, 87 Stat. 93; Pub. L. 94–63, title II, § 202(c),
title VII, § 701(d), July 29, 1975, 89 Stat. 306, 352;
Pub. L. 95–83, title III, § 305(c), Aug. 1, 1977, 91
Stat. 389; Pub. L. 95–613, § 1(b)(3), Nov. 8, 1978, 92
Stat. 3093; Pub. L. 96–32, § 1(a), July 10, 1979, 93
Stat. 82; Pub. L. 97–35, title IX, § 931(b)(2), Aug.
13, 1981, 95 Stat. 570.)
AMENDMENTS
1981—Pub. L. 97–35 redesignated existing subsec. (a) as
entire section, and struck out subsec. (b) which related
to authorization and availability of appropriations.
1979—Subsec. (b)(1). Pub. L. 95–613, as amended by
Pub. L. 96–32, substituted ‘‘$120,800,000’’ for ‘‘$3,600,000’’
as authorized appropriation for fiscal year ending Sept.
30, 1980.
1978—Subsec. (b)(1). Pub. L. 95–613 inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1979, 1980, and 1981.
1977—Subsec. (b). Pub. L. 95–83 in par. (1) substituted
provisions authorizing appropriations for fiscal years
ending Sept. 30, 1977 and 1978, for prior such authorization for fiscal year 1977, and in par. (2) prohibited use
of funds for administration of this section.
1975—Subsec. (a). Pub. L. 94–63, § 202(c), revised structure of provisions, inserted authorization for Secretary
to conduct research, and struck out authority for
grants and contracts in research training in specified
fields.
Subsec. (b). Pub. L. 94–63, §§ 202(c), 701(d), revised
structure of provisions and substituted provisions relating to authorization of appropriations for fiscal
years 1976 and 1977 and availability of appropriated
funds, for provisions authorizing appropriations for fis-

Page 902

cal years ending June 30, 1971, through fiscal year ending June 30, 1975.
1973—Subsec. (b). Pub. L. 93–45 inserted provisions authorizing appropriations for fiscal year ending June 30,
1974.
EFFECTIVE DATE OF 1979 AMENDMENT
Section 1(b) of Pub. L. 96–32 provided that: ‘‘The
amendment made by subsection (a) [amending this section] shall be effective as of November 8, 1978.’’
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by section 202(c) of Pub. L. 94–63 effective
July 1, 1975, see section 608 of Pub. L. 94–63, set out as
a note under section 247b of this title.

§ 300a–3. Informational and educational materials development grants and contracts; authorization of appropriations
(a) The Secretary is authorized to make
grants to public or nonprofit private entities
and to enter into contracts with public or private entities and individuals to assist in developing and making available family planning and
population growth information (including educational materials) to all persons desiring such
information (or materials).
(b) For the purpose of making payments pursuant to grants and contracts under this section, there are authorized to be appropriated
$750,000 for the fiscal year ending June 30, 1971;
$1,000,000 for the fiscal year ending June 30, 1972;
$1,250,000 for the fiscal year ending June 30, 1973;
$909,000 each for the fiscal years ending June 30,
1974, and June 30, 1975; $2,000,000 for fiscal year
1976; $2,500,000 for the fiscal year ending September 30, 1977; $600,000 for the fiscal year ending
September 30, 1978; $700,000 for the fiscal year
ending September 30, 1979; $805,000 for the fiscal
year ending September 30, 1980; $926,000 for the
fiscal year ending September 30, 1981; $570,000 for
the fiscal year ending September 30, 1982;
$600,000 for the fiscal year ending September 30,
1983; $670,000 for the fiscal year ending September 30, 1984; and $700,000 for the fiscal year ending September 30, 1985.
(July 1, 1944, ch. 373, title X, § 1005, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1507;
amended Pub. L. 93–45, title I, § 111(d), June 18,
1973, 87 Stat. 93; Pub. L. 94–63, title II, § 202(d),
title VII, § 701(d), July 29, 1975, 89 Stat. 307, 352;
Pub. L. 95–83, title III, § 305(d), Aug. 1, 1977, 91
Stat. 389; Pub. L. 95–613, § 1(b)(4), Nov. 8, 1978, 92
Stat. 3093; Pub. L. 97–35, title IX, § 931(a)(3), Aug.
13, 1981, 95 Stat. 570; Pub. L. 97–414, §§ 8(n), 9(a),
Jan. 4, 1983, 96 Stat. 2061, 2064; Pub. L. 98–512,
§ 3(c), Oct. 19, 1984, 98 Stat. 2410.)
AMENDMENTS
1984—Subsec. (b). Pub. L. 98–512 inserted provisions
authorizing appropriations for fiscal year ending Sept.
30, 1985.
1983—Subsec. (b). Pub. L. 97–414, § 8(n), substituted a
semicolon for a comma after ‘‘1981’’.
Pub. L. 97–414, § 9(a), amended directory language of
Pub. L. 97–35, § 931(a)(3), to correct typographical error
and did not involve any change in text. See 1981
Amendment note below.
1981—Subsec. (b). Pub. L. 97–35, as amended by Pub. L.
97–414, § 9(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and
1984.
1978—Subsec. (b). Pub. L. 95–613 inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1979, 1980, and 1981.

Page 903

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1977—Subsec. (b). Pub. L. 95–83 substituted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1977 and 1978, for prior such authorization for fiscal
year 1977.
1975—Subsec. (b). Pub. L. 94–63 inserted provisions authorizing appropriations for fiscal years ending June 30,
1975, 1976, and 1977.
1973—Subsec. (b). Pub. L. 93–45 inserted provisions authorizing appropriations for fiscal year ending June 30,
1974.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by section 202(d) of Pub. L. 94–63 effective July 1, 1975, see section 608 of Pub. L. 94–63, set out
as a note under section 247b of this title.

§ 300a–4. Grants and contracts
(a) Promulgation of regulations governing execution; amount of grants
Grants and contracts made under this subchapter shall be made in accordance with such
regulations as the Secretary may promulgate.
The amount of any grant under any section of
this subchapter shall be determined by the Secretary; except that no grant under any such section for any program or project for a fiscal year
beginning after June 30, 1975, may be made for
less than 90 per centum of its costs (as determined under regulations of the Secretary) unless the grant is to be made for a program or
project for which a grant was made (under the
same section) for the fiscal year ending June 30,
1975, for less than 90 per centum of its costs (as
so determined), in which case a grant under such
section for that program or project for a fiscal
year beginning after that date may be made for
a percentage which shall not be less than the
percentage of its costs for which the fiscal year
1975 grant was made.
(b) Payment of grants
Grants under this subchapter shall be payable
in such installments and subject to such conditions as the Secretary may determine to be appropriate to assure that such grants will be effectively utilized for the purposes for which
made.
(c) Prerequisites; ‘‘low-income family’’ defined
A grant may be made or contract entered into
under section 300 or 300a of this title for a family
planning service project or program only upon
assurances satisfactory to the Secretary that—
(1) priority will be given in such project or
program to the furnishing of such services to
persons from low-income families; and
(2) no charge will be made in such project or
program for services provided to any person
from a low-income family except to the extent
that payment will be made by a third party
(including a government agency) which is authorized or is under legal obligation to pay
such charge.
For purposes of this subsection, the term ‘‘lowincome family’’ shall be defined by the Secretary in accordance with such criteria as he
may prescribe so as to insure that economic
status shall not be a deterrent to participation
in the programs assisted under this subchapter.
(d) Suitability of informational or educational
materials
(1) A grant may be made or a contract entered
into under section 300 or 300a–3 of this title only

§ 300a–6a

upon assurances satisfactory to the Secretary
that informational or educational materials developed or made available under the grant or
contract will be suitable for the purposes of this
subchapter and for the population or community
to which they are to be made available, taking
into account the educational and cultural background of the individuals to whom such materials are addressed and the standards of such
population or community with respect to such
materials.
(2) In the case of any grant or contract under
section 300 of this title, such assurances shall
provide for the review and approval of the suitability of such materials, prior to their distribution, by an advisory committee established by
the grantee or contractor in accordance with
the Secretary’s regulations. Such a committee
shall include individuals broadly representative
of the population or community to which the
materials are to be made available.
(July 1, 1944, ch. 373, title X, § 1006, as added
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat.
amended Pub. L. 94–63, title II, § 204(c), (d),
29, 1975, 89 Stat. 308; Pub. L. 95–613, § 1(a)(2),
8, 1978, 92 Stat. 3093.)

Pub.
1507;
July
Nov.

AMENDMENTS
1978—Pub. L. 95–613 added subsec. (d).
1975—Subsec. (a). Pub. L. 94–63, § 204(c), inserted provisions relating to amount of grants authorized pursuant to sections of this subchapter.
Subsec. (c). Pub. L. 94–63, § 204(d), inserted provision
relating to economic status as part of the criteria to be
included within definition of ‘‘low-income family’’.
EFFECTIVE DATE OF 1975 AMENDMENT
Amendment by Pub. L. 94–63 effective July 1, 1975, see
section 608 of Pub. L. 94–63, set out as a note under section 247b of this title.

§ 300a–5. Voluntary participation by individuals;
participation not prerequisite for eligibility
or receipt of other services and information
The acceptance by any individual of family
planning services or family planning or population growth information (including educational materials) provided through financial
assistance under this subchapter (whether by
grant or contract) shall be voluntary and shall
not be a prerequisite to eligibility for or receipt
of any other service or assistance from, or to
participation in, any other program of the entity or individual that provided such service or
information.
(July 1, 1944, ch. 373, title X, § 1007, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1508.)
§ 300a–6. Prohibition against funding programs
using abortion as family planning method
None of the funds appropriated under this subchapter shall be used in programs where abortion is a method of family planning.
(July 1, 1944, ch. 373, title X, § 1008, as added Pub.
L. 91–572, § 6(c), Dec. 24, 1970, 84 Stat. 1508.)
§ 300a–6a. Repealed. Pub. L. 105–362, title VI,
§ 601(a)(1)(G), Nov. 10, 1998, 112 Stat. 3285
Section, act July 1, 1944, ch. 373, title X, § 1009, as
added Pub. L. 94–63, title II, § 203(a), July 29, 1975, 89

§ 300a–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 307; amended Pub. L. 96–88, title V, § 509(b), Oct.
17, 1979, 93 Stat. 695; Pub. L. 104–66, title I, § 1062(c), Dec.
21, 1995, 109 Stat. 720, related to plans and reports concerning family planning services.

§ 300a–7. Sterilization or abortion
(a) Omitted
(b) Prohibition of public officials and public authorities from imposition of certain requirements contrary to religious beliefs or moral
convictions
The receipt of any grant, contract, loan, or
loan guarantee under the Public Health Service
Act [42 U.S.C. 201 et seq.], the Community Mental Health Centers Act [42 U.S.C. 2689 et seq.], or
the Developmental Disabilities Services and Facilities Construction Act [42 U.S.C. 6000 et seq.]
by any individual or entity does not authorize
any court or any public official or other public
authority to require—
(1) such individual to perform or assist in
the performance of any sterilization procedure
or abortion if his performance or assistance in
the performance of such procedure or abortion
would be contrary to his religious beliefs or
moral convictions; or
(2) such entity to—
(A) make its facilities available for the
performance of any sterilization procedure
or abortion if the performance of such procedure or abortion in such facilities is prohibited by the entity on the basis of religious
beliefs or moral convictions, or
(B) provide any personnel for the performance or assistance in the performance of any
sterilization procedure or abortion if the
performance or assistance in the performance of such procedures or abortion by such
personnel would be contrary to the religious
beliefs or moral convictions of such personnel.
(c) Discrimination prohibition
(1) No entity which receives a grant, contract,
loan, or loan guarantee under the Public Health
Service Act [42 U.S.C. 201 et seq.], the Community Mental Health Centers Act [42 U.S.C. 2689 et
seq.], or the Developmental Disabilities Services
and Facilities Construction Act [42 U.S.C. 6000 et
seq.] after June 18, 1973, may—
(A) discriminate in the employment, promotion, or termination of employment of any
physician or other health care personnel, or
(B) discriminate in the extension of staff or
other privileges to any physician or other
health care personnel,
because he performed or assisted in the performance of a lawful sterilization procedure or abortion, because he refused to perform or assist in
the performance of such a procedure or abortion
on the grounds that his performance or assistance in the performance of the procedure or
abortion would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting
sterilization procedures or abortions.
(2) No entity which receives after July 12, 1974,
a grant or contract for biomedical or behavioral
research under any program administered by the
Secretary of Health and Human Services may—

Page 904

(A) discriminate in the employment, promotion, or termination of employment of any
physician or other health care personnel, or
(B) discriminate in the extension of staff or
other privileges to any physician or other
health care personnel,
because he performed or assisted in the performance of any lawful health service or research activity, because he refused to perform or assist in
the performance of any such service or activity
on the grounds that his performance or assistance in the performance of such service or activity would be contrary to his religious beliefs or
moral convictions, or because of his religious beliefs or moral convictions respecting any such
service or activity.
(d) Individual rights respecting certain requirements contrary to religious beliefs or moral
convictions
No individual shall be required to perform or
assist in the performance of any part of a health
service program or research activity funded in
whole or in part under a program administered
by the Secretary of Health and Human Services
if his performance or assistance in the performance of such part of such program or activity
would be contrary to his religious beliefs or
moral convictions.
(e) Prohibition on entities receiving Federal
grant, etc., from discriminating against applicants for training or study because of refusal of applicant to participate on religious
or moral grounds
No entity which receives, after September 29,
1979, any grant, contract, loan, loan guarantee,
or interest subsidy under the Public Health
Service Act [42 U.S.C. 201 et seq.], the Community Mental Health Centers Act [42 U.S.C. 2689 et
seq.], or the Developmental Disabilities Assistance and Bill of Rights Act of 2000 [42 U.S.C.
15001 et seq.] may deny admission or otherwise
discriminate against any applicant (including
applicants for internships and residencies) for
training or study because of the applicant’s reluctance, or willingness, to counsel, suggest,
recommend, assist, or in any way participate in
the performance of abortions or sterilizations
contrary to or consistent with the applicant’s
religious beliefs or moral convictions.
(Pub. L. 93–45, title IV, § 401, June 18, 1973, 87
Stat. 95; Pub. L. 93–348, title II, § 214, July 12,
1974, 88 Stat. 353; Pub. L. 96–76, title II, § 208,
Sept. 29, 1979, 93 Stat. 583; Pub. L. 96–88, title V,
§ 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 106–402,
title IV, § 401(b)(5), Oct. 30, 2000, 114 Stat. 1738.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsecs.
(b), (c)(1), and (e), is act July 1, 1944, ch. 373, 58 Stat.
682, as amended, which is classified generally to this
chapter (§ 201 et seq.). For complete classification of
this Act to the Code, see Short Title note set out under
section 201 of this title and Tables.
The Community Mental Health Centers Act, referred
to in subsecs. (b), (c)(1), and (e), is title II of Pub. L.
88–164, as added Pub. L. 94–63, title III, § 303, July 29,
1975, 89 Stat. 309, and amended, which was classified
principally to subchapter III (§ 2689 et seq.) of chapter 33
of this title prior to its repeal by Pub. L. 97–35, title IX,
§ 902(e)(2)(B), Aug. 13, 1981, 95 Stat. 560.

Page 905

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300a–29

The Developmental Disabilities Services and Facilities Construction Act, referred to in subsecs. (b) and
(c)(1), is title I of Pub. L. 88–164, Oct. 31, 1963, 77 Stat.
282, as renamed by Pub. L. 91–518, title II, § 207(a), Oct.
30, 1970, 84 Stat. 1327. Title I of Pub. L. 88–164, which
was subsequently renamed the Developmental Disabilities Assistance and Bill of Rights Act by Pub. L.
95–602, title V, § 502, Nov. 6, 1978, 92 Stat. 3003, and
amended generally by Pub. L. 98–527, § 2, Oct. 19, 1984, 98
Stat. 2662, was classified generally to chapter 75 (§ 6000
et seq.) of this title, prior to repeal by Pub. L. 106–402,
title IV, § 401(a), Oct. 30, 2000, 114 Stat. 1737. For complete classification of this Act to the Code, see Tables.
The Developmental Disabilities Assistance and Bill of
Rights Act of 2000, referred to in subsec. (e), is Pub. L.
106–402, Oct. 30, 2000, 114 Stat. 1677, which is classified
principally to chapter 144 (§ 15001 et seq.) of this title.
For complete classification of this Act to the Code, see
Short Title note set out under section 15001 of this title
and Tables.

the Public Health Service Act which comprises this
chapter.

CODIFICATION

Section 300a–21, Pub. L. 95–626, title VI, § 601, Nov. 10,
1978, 92 Stat. 3595, set forth Congressional findings and
declaration of purpose with respect to grant program.
Section 300a–22, Pub. L. 95–626, title VI, § 602, Nov. 10,
1978, 92 Stat. 3595; Pub. L. 96–88, title V, § 509(b), Oct. 17,
1979, 93 Stat. 695, defined terms ‘‘Secretary’’, ‘‘eligible
person’’, ‘‘eligible grant recipient’’, ‘‘core services’’,
‘‘supplemental services’’, ‘‘adolescent parent’’.
Section 300a–23, Pub. L. 95–626, title VI, § 603, Nov. 10,
1978, 92 Stat. 3596, set forth authority to make grants.
Section 300a–24, Pub. L. 95–626, title VI, § 604, Nov. 10,
1978, 92 Stat. 3597, set forth authorized uses for grants.
Section 300a–25, Pub. L. 95–626, title VI, § 605, Nov. 10,
1978, 92 Stat. 3597, set forth provisions respecting priorities, amounts, and duration of grants.
Section 300a–26, Pub. L. 95–626, title VI, § 606, Nov. 10,
1978, 92 Stat. 3598, set forth application, etc., requirements for grant approval.
Section 300a–27, Pub. L. 95–626, title VI, § 607, Nov. 10,
1978, 92 Stat. 3601; Pub. L. 97–35, title XXI, § 2193(a)(2),
Aug. 13, 1981, 95 Stat. 827, authorized appropriations
from fiscal year ending Sept. 30, 1979, through fiscal
year ending Sept. 30, 1982.
Section 300a–28, Pub. L. 95–626, title VI, § 608, Nov. 10,
1978, 92 Stat. 3601, set forth prohibition respecting use
of funds to pay for performance of abortion.
See section 300z et seq. of this title.

Section was enacted as part of Health Programs Extension Act of 1973, and not as part of Public Health
Services Act which comprises this chapter.
Subsec. (a) of this section amended section 601 of Pub.
L. 91–296, which is set out as an Availability of Appropriations note under section 201 of this title.
AMENDMENTS
2000—Subsec. (e). Pub. L. 106–402 substituted ‘‘or the
Developmental Disabilities Assistance and Bill of
Rights Act of 2000 may deny’’ for ‘‘or the Developmental Disabilities Assistance and Bill of Rights Act
may deny’’.
1979—Subsec. (e). Pub. L. 96–76 added subsec. (e).
1974—Subsec. (c). Pub. L. 93–348, § 214, designated existing provisions as par. (1), redesignated pars. (1) and
(2) of such provisions as subpars. (A) and (B), and added
par. (2).
Subsec. (d). Pub. L. 93–348, § 214(b), added subsec. (d).
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsecs. (c)(2) and (d), pursuant to section
509(b) of Pub. L. 96–88 which is classified to section
3508(b) of Title 20, Education.

§ 300a–8. Penalty for United States, etc., officer
or employee coercing or endeavoring to coerce procedure upon beneficiary of Federal
program
Any—
(1) officer or employee of the United States,
(2) officer or employee of any State, political
subdivision of a State, or any other entity,
which administers or supervises the administration of any program receiving Federal financial assistance, or
(3) person who receives, under any program
receiving Federal financial assistance, compensation for services,
who coerces or endeavors to coerce any person
to undergo an abortion or sterilization procedure by threatening such person with the loss of,
or disqualification for the receipt of, any benefit
or service under a program receiving Federal financial assistance shall be fined not more than
$1,000 or imprisoned for not more than one year,
or both.
(Pub. L. 94–63, title II, § 205, July 29, 1975, 89 Stat.
308.)
CODIFICATION
Section was enacted as part of the Family Planning
and Population Research Act of 1975, and not as part of

EFFECTIVE DATE
Section effective July 1, 1975, see section 608 of Pub.
L. 94–63, set out as an Effective Date of 1975 Amendment note under section 247b of this title.

SUBCHAPTER VIII–A—ADOLESCENT
PREGNANCIES
PART A—GRANT PROGRAM
§§ 300a–21 to 300a–28. Repealed. Pub. L. 97–35,
title IX, § 955(b), title XXI, § 2193(f), Aug. 13,
1981, 95 Stat. 592, 828

EFFECTIVE DATE OF REPEAL
Section 955(b) of Pub. L. 97–35 provided that the repeal of sections 300a–21 to 300a–28 of this title is effective Oct. 1, 1981.
For effective date, savings, and transitional provisions relating to the repeal of sections 321a–21 to
321a–28 of this title by section 2193(f) of Pub. L. 97–35,
and relating to the amendment of section 300a–27 of
this title by section 2193(a)(2) of Pub. L. 97–35, see section 2194 of Pub. L. 97–35, set out as a note under section 701 of this title.
STUDY OF ADOLESCENT PREGNANCY; REPORT NOT
LATER THAN NOVEMBER 10, 1979
Pub. L. 95–626, title VIII, § 801, Nov. 10, 1978, 92 Stat.
3602, which provided for a study of the problem of adolescent pregnancies and the effectiveness of existing
programs and a report, was repealed by section 955(b) of
Pub. L. 97–35.

§ 300a–29. Omitted
CODIFICATION
Section, Pub. L. 95–626, title III, § 301, Nov. 10, 1978, 92
Stat. 3590, provided that grants or contracts made
under this subchapter would be considered to have been
made under this chapter for the purposes of sections
300l–2(e) and 300m–3(c)(6) of this title.

§ 300a–41

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART B—IMPROVING COORDINATION OF FEDERAL
AND STATE PROGRAMS
§ 300a–41. Repealed. Pub. L. 97–35, title IX,
§ 955(b), title XXI, § 2193(f), Aug. 13, 1981, 95
Stat. 592, 828
Section, Pub. L. 95–626, title VII, § 701, Nov. 10, 1978, 92
Stat. 3601; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695, related to improving coordination of Federal
and State policies and programs.
EFFECTIVE DATE OF REPEAL
Section 955(b) of Pub. L. 97–35 provided that the repeal of this section is effective Oct. 1, 1981.
For effective date, savings, and transitional provisions relating to the repeal of this section by section
2193(f) of Pub. L. 97–35, see section 2194 of Pub. L. 97–35,
set out as a note under section 701 of this title.

SUBCHAPTER IX—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME
AMENDMENTS
1976—Pub. L. 94–278, title IV, § 403(b)(3), Apr. 22, 1976,
90 Stat. 409, substituted ‘‘GENETIC DISEASES’’ for
‘‘GENETIC BLOOD DISORDERS’’ and inserted ‘‘HEMOPHILIA PROGRAMS’’ in subchapter heading.
1974—Pub. L. 93–270, § 3(b), Apr. 22, 1974, 88 Stat. 92, inserted ‘‘SUDDEN INFANT DEATH SYNDROME’’ in
subchapter heading.
1972—Pub. L. 92–414, § 4(1), Aug. 29, 1972, 86 Stat. 652,
substituted ‘‘GENETIC BLOOD DISORDERS’’ for
‘‘SICKLE CELL ANEMIA PROGRAM’’ as subchapter
heading and designated former subchapter heading as
part A, substituting ‘‘Programs’’ for ‘‘Program’’.

PART A—GENETIC DISEASES
AMENDMENTS
1976—Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 407, substituted ‘‘Genetic Diseases’’ for ‘‘Sickle
Cell Anemia Programs’’ in part A heading.

§ 300b. Repealed. Pub. L. 97–35, title
§ 2193(b)(1), Aug. 13, 1981, 95 Stat. 827

profit private entities, and may enter into contracts with public and private entities and individuals, for projects for (1) basic or applied research leading to the understanding, diagnosis,
treatment, and control of genetic diseases, (2)
planning, establishing, demonstrating, and developing special programs for the training of genetic counselors, social and behavioral scientists, and other health professionals, (3) the
development of programs to educate practicing
physicians, other health professionals, and the
public regarding the nature of genetic processes,
the inheritance patterns of genetic diseases, and
the means, methods, and facilities available to
diagnose, control, counsel, and treat genetic diseases, and (4) the development of counseling and
testing programs and other programs for the diagnosis, control, and treatment of genetic diseases. In making grants and entering into contracts for projects described in clause (1) of the
preceding sentence, the Secretary shall give priority to applications for such grants or contracts which are submitted for research on sickle cell anemia and for research on Cooley’s anemia.
(July 1, 1944, ch. 373, title XI, § 1102, as added
Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 408.)
PRIOR PROVISIONS
A prior section 300b–1, act July 1, 1944, ch. 373, title
XI, § 1102, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 138, authorized Secretary to make grants and
enter contracts with public and private entities and individuals for projects concerned with research, research
training in diagnosis, treatment and control of sickle
cell anemia, informational and educational programs
with respect to sickle cell anemia and development of
counseling and testing programs, prior to repeal by
Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat.
407.

XXI,

Section, act July 1, 1944, ch. 373, title XI, § 1101, as
added Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(a), 90
Stat. 407; amended Nov. 10, 1978, Pub. L. 95–626, title II,
§ 205(b), (d)(2), (e), 92 Stat. 3583, 3584; Pub. L. 96–88, title
V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Aug. 13, 1981, Pub.
L. 97–35, title XXI, § 2193(a)(1)(B), 95 Stat. 826; Jan. 4,
1983, Pub. L. 97–414, § 8(o), 96 Stat. 2061, related to testing, counseling, information and education programs.
A prior section 300b, act July 1, 1944, ch. 373, title XI,
§ 1101, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 137; amended Aug. 29, 1972, Pub. L. 92–414, § 4(2), 86
Stat. 652, authorized Secretary to make grants and
enter contracts with public and nonprofit private entities with respect to establishment of voluntary sickle
cell anemia screening and counseling programs and to
develop and disseminate informational and educational
materials relating to sickle cell anemia, prior to repeal
by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat.
407.
EFFECTIVE DATE OF 1981 AMENDMENT AND REPEAL,
SAVINGS, AND TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to the amendment and repeal of this section by Pub. L. 97–35, see section 2194 of Pub. L. 97–35,
set out as a note under section 701 of this title.

§ 300b–1. Research project grants and contracts
In carrying out section 241 of this title, the
Secretary may make grants to public and non-

Page 906

EFFECTIVE DATE
Section 403(c) of Pub. L. 94–278 provided that: ‘‘The
amendments made by subsections (a) and (b) [see section 401 of Pub. L. 94–278, set out as a Short Title of 1976
Amendment note under section 201 of this title] shall
take effect July 1, 1976.’’
SHORT TITLE OF 1976 AMENDMENT
For short title of title IV of Pub. L. 94–278, which enacted this part, omitted former part B of this subchapter, redesignated former parts C and D of this subchapter as parts B and C of this subchapter, respectively, as the ‘‘National Sickle Cell Anemia, Cooley’s
Anemia, Tay-Sachs, and Genetic Diseases Act’’, see section 401 of Pub. L. 94–278, set out as a note under section 201 of this title.
DEMONSTRATION PROGRAM FOR THE DEVELOPMENT AND
ESTABLISHMENT OF SYSTEMIC MECHANISMS FOR THE
PREVENTION AND TREATMENT OF SICKLE CELL DISEASE

Pub. L. 108–357, title VII, § 712(c), Oct. 22, 2004, 118
Stat. 1559, provided that:
‘‘(1) AUTHORITY TO CONDUCT DEMONSTRATION PROGRAM.—
‘‘(A) IN GENERAL.—The Administrator, through the
Bureau of Primary Health Care and the Maternal and
Child Health Bureau, shall conduct a demonstration
program by making grants to up to 40 eligible entities for each fiscal year in which the program is conducted under this section [probably means this subsection] for the purpose of developing and establishing systemic mechanisms to improve the prevention

Page 907

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and treatment of Sickle Cell Disease, including
through—
‘‘(i) the coordination of service delivery for individuals with Sickle Cell Disease;
‘‘(ii) genetic counseling and testing;
‘‘(iii) bundling of technical services related to the
prevention and treatment of Sickle Cell Disease;
‘‘(iv) training of health professionals; and
‘‘(v) identifying and establishing other efforts related to the expansion and coordination of education, treatment, and continuity of care programs
for individuals with Sickle Cell Disease.
‘‘(B) GRANT AWARD REQUIREMENTS.—
‘‘(i) GEOGRAPHIC DIVERSITY.—The Administrator
shall, to the extent practicable, award grants under
this section [probably means this subsection] to eligible entities located in different regions of the
United States.
‘‘(ii) PRIORITY.—In awarding grants under this
subsection, the Administrator shall give priority to
awarding grants to eligible entities that are—
‘‘(I) Federally-qualified health centers that
have a partnership or other arrangement with a
comprehensive Sickle Cell Disease treatment center that does not receive funds from the National
Institutes of Health; or
‘‘(II) Federally-qualified health centers that intend to develop a partnership or other arrangement with a comprehensive Sickle Cell Disease
treatment center that does not receive funds from
the National Institutes of Health.
‘‘(2) ADDITIONAL REQUIREMENTS.—An eligible entity
awarded a grant under this subsection shall use funds
made available under the grant to carry out, in addition to the activities described in paragraph (1)(A), the
following activities:
‘‘(A) To facilitate and coordinate the delivery of
education, treatment, and continuity of care for individuals with Sickle Cell Disease under—
‘‘(i) the entity’s collaborative agreement with a
community-based Sickle Cell Disease organization
or a nonprofit entity that works with individuals
who have Sickle Cell Disease;
‘‘(ii) the Sickle Cell Disease newborn screening
program for the State in which the entity is located; and
‘‘(iii) the maternal and child health program
under title V of the Social Security Act (42 U.S.C.
701 et seq.) for the State in which the entity is located.
‘‘(B) To train nursing and other health staff who
provide care for individuals with Sickle Cell Disease.
‘‘(C) To enter into a partnership with adult or pediatric hematologists in the region and other regional
experts in Sickle Cell Disease at tertiary and academic health centers and State and county health offices.
‘‘(D) To identify and secure resources for ensuring
reimbursement under the medicaid program, State
children’s health insurance program, and other
health programs for the prevention and treatment of
Sickle Cell Disease.
‘‘(3) NATIONAL COORDINATING CENTER.—
‘‘(A) ESTABLISHMENT.—The Administrator shall
enter into a contract with an entity to serve as the
National Coordinating Center for the demonstration
program conducted under this subsection.
‘‘(B) ACTIVITIES DESCRIBED.—The National Coordinating Center shall—
‘‘(i) collect, coordinate, monitor, and distribute
data, best practices, and findings regarding the activities funded under grants made to eligible entities under the demonstration program;
‘‘(ii) develop a model protocol for eligible entities
with respect to the prevention and treatment of
Sickle Cell Disease;
‘‘(iii) develop educational materials regarding the
prevention and treatment of Sickle Cell Disease;
and
‘‘(iv) prepare and submit to Congress a final report that includes recommendations regarding the

§ 300b–2

effectiveness of the demonstration program conducted under this subsection and such direct outcome measures as—
‘‘(I) the number and type of health care resources utilized (such as emergency room visits,
hospital visits, length of stay, and physician visits for individuals with Sickle Cell Disease); and
‘‘(II) the number of individuals that were tested
and subsequently received genetic counseling for
the sickle cell trait.
‘‘(4) APPLICATION.—An eligible entity desiring a grant
under this subsection shall submit an application to
the Administrator at such time, in such manner, and
containing such information as the Administrator may
require.
‘‘(5) DEFINITIONS.—In this subsection:
‘‘(A) ADMINISTRATOR.—The term ‘Administrator’
means the Administrator of the Health Resources and
Services Administration.
‘‘(B) ELIGIBLE ENTITY.—The term ‘eligible entity’
means a Federally-qualified health center, a nonprofit hospital or clinic, or a university health center
that provides primary health care, that—
‘‘(i) has a collaborative agreement with a community-based Sickle Cell Disease organization or a
nonprofit entity with experience in working with
individuals who have Sickle Cell Disease; and
‘‘(ii) demonstrates to the Administrator that either the Federally-qualified health center, the nonprofit hospital or clinic, the university health center, the organization or entity described in clause
(i), or the experts described in paragraph (2)(C), has
at least 5 years of experience in working with individuals who have Sickle Cell Disease.
‘‘(C) FEDERALLY-QUALIFIED HEALTH CENTER.—The
term ‘Federally-qualified health center’ has the
meaning given that term in section 1905(l)(2)(B) of the
Social Security Act (42 U.S.C. 1396d(l)(2)(B)).
‘‘(6) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this subsection, $10,000,000 for each of fiscal years 2005 through
2009.’’
CONGRESSIONAL DECLARATION OF PURPOSE
Pub. L. 94–278, title IV, § 402, Apr. 22, 1976, 90 Stat. 407,
as amended by Pub. L. 95–626, title II, § 205(a), Nov. 10,
1978, 92 Stat. 3583; Pub. L. 111–256, § 2(i), Oct. 5, 2010, 124
Stat. 2644, provided that: ‘‘In order to preserve and protect the health and welfare of all citizens, it is the purpose of this title [see section 401 of Pub. L. 94–278, set
out as a Short Title of 1976 Amendment note under section 201 of this title] to establish a national program to
provide for basic and applied research, research training, testing, counseling, and information and education
programs with respect to genetic diseases, and genetic
conditions, such as Sickle Cell anemia, Cooley’s Anemia, Tay–Sachs disease, cystic fibrosis, dysautonomia,
hemophilia, retinitis pigmentosa, Huntington’s chorea,
muscular dystrophy, and genetic conditions leading to
intellectual disabilities or genetically caused mental
disorders.’’
[For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.]

§ 300b–2. Voluntary participation by individuals
The participation by any individual in any
program or portion thereof under this part shall
be wholly voluntary and shall not be a prerequisite to eligibility for or receipt of any
other service or assistance from, or to participation in, any other program.
(July 1, 1944, ch. 373, title XI, § 1103, as added
Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 408.)

§ 300b–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 300b–2, act July 1, 1944, ch. 373, title
XI, § 1103, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 138; amended Aug. 29, 1972, Pub. L. 92–414, § 4(3), 86
Stat. 652, was identical to this section, prior to repeal
by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat.
407.

§ 300b–3. Application; special consideration to
prior sickle cell anemia grant recipients
(a) Manner of submission; contents
A grant or contract under this part may be
made upon application submitted to the Secretary at such time, in such manner, and containing and accompanied by such information,
as the Secretary may require, including assurances for an evaluation whether performed by
the applicant or by the Secretary. Such grant or
contract may be made available on less than a
statewide or regional basis. Each applicant
shall—
(1) provide that the programs and activities
for which assistance under this part is sought
will be administered by or under the supervision of the applicant;
(2) provide for strict confidentiality of all
test results, medical records, and other information regarding testing, diagnosis, counseling, or treatment of any person treated, except
for (A) such information as the patient (or his
guardian) gives informed consent to be released, or (B) statistical data compiled without reference to the identity of any such patient;
(3) provide for community representation
where appropriate in the development and operation of voluntary genetic testing or counseling programs funded by a grant or contract
under this part; and
(4) establish fiscal control and fund accounting procedures as may be necessary to assure
proper disbursement of and accounting of Federal funds paid to the applicant under this
part.
(b) Considerations for grants and contracts
under section 300b–1 of this title
In making grants and entering into contracts
for any fiscal year under section 241 of this title
for projects described in section 300b–1 of this
title the Secretary shall give special consideration to applications from entities that received
grants from, or entered into contracts with, the
Secretary for the preceding fiscal year for the
conduct of comprehensive sickle cell centers or
sickle cell screening and education clinics.
(July 1, 1944, ch. 373, title XI, § 1104, as added
Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 408; amended Pub. L. 95–626, title II,
§ 205(c), Nov. 10, 1978, 92 Stat. 3584; Pub. L. 97–35,
title XXI, § 2193(b)(2), (3), Aug. 13, 1981, 95 Stat.
827.)
PRIOR PROVISIONS
A prior section 300b–3, act July 1, 1944, ch. 373, title
XI, § 1104, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 138; amended Aug. 29, 1972, Pub. L. 92–414, § 4(3), 86
Stat. 652, authorized grants to be made upon application to Secretary and required supervision of programs
by applicant, confidentiality of test results, medical
records and other information obtained from treated

Page 908

person, community representation in programs, assurances by applicant that priority will be given to persons of child bearing years, and demonstration by applicant of proper fiscal control and accounting procedures, prior to repeal by Pub. L. 94–278, title IV, § 403(a),
Apr. 22, 1976, 90 Stat. 407.
AMENDMENTS
1981—Subsec. (a)(4), (5). Pub. L. 97–35, § 2193(b)(2), redesignated par. (5) as (4). Former par. (4), which related
to testing and counseling requirements, was struck
out.
Subsec. (b). Pub. L. 97–35, § 2193(b)(3), struck out subsec. (b) which related to grants and contracts under
section 300b of this title. Former subsec. (c) was redesignated (b) and, as so redesignated, struck out reference to section 300b of this title.
Subsec. (c). Pub. L. 97–35, § 2193(b)(3), redesignated
subsec. (c) as (b).
Subsec. (d). Pub. L. 97–35, § 2193(b)(3), struck out subsec. (d) which related to procedures applicable to
grants, etc., under section 300b of this title.
1978—Subsec. (a). Pub. L. 95–626, § 205(c)(1), inserted
requirement that application contain assurances for an
evaluation whether performed by applicant or by Secretary and that grant or contract be made available on
less than a statewide or regional basis.
Subsec. (d). Pub. L. 95–626, § 205(c)(2), added subsec.
(d).
EFFECTIVE DATE OF 1981 AMENDMENT, SAVINGS, AND
TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to amendment by Pub. L. 97–35, see section 2194 of Pub. L. 97–35, set out as a note under section 701 of this title.

§ 300b–4. Public Health Service facilities
The Secretary shall establish a program within the Service to provide voluntary testing, diagnosis, counseling, and treatment of individuals respecting genetic diseases. Services under
such program shall be made available through
facilities of the Service to persons requesting
such services, and the program shall provide appropriate publicity of the availability and voluntary nature of such services.
(July 1, 1944, ch. 373, title XI, § 1105, as added
Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 409.)
PRIOR PROVISIONS
A prior section 300b–4, act July 1, 1944, ch. 373, title
XI, § 1105, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 139, authorized Secretary to establish a program
within the Public Health Service with respect to sickle
cell anemia with such program to be made available
through facilities of Public Health Service, prior to repeal by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90
Stat. 407.

§ 300b–5. Repealed. Pub. L. 97–35, title XXI,
§ 2193(b)(4), Aug. 13, 1981, 95 Stat. 827
Section, act July 1, 1944, ch. 373, title XI, § 1106, as
added Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(a), 90
Stat. 409, related to an annual report to President and
Congress on administration of this part.
A prior section 300b–5, act July 1, 1944, ch. 373, title
XI, § 1106, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86
Stat. 139; amended Aug. 29, 1972, Pub. L. 92–414, § 4(3), 86
Stat. 652, related to an annual report to President and
Congress on administration of this part, prior to repeal
by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat.
407.

Page 909

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF REPEAL, SAVINGS, AND
TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to repeal by Pub. L. 97–35, see section
2194 of Pub. L. 97–35, set out as a note under section 701
of this title.

§ 300b–6. Applied technology
The Secretary, acting through an identifiable
administrative unit, shall—
(1) conduct epidemiological assessments and
surveillance of genetic diseases to define the
scope and extent of such diseases and the need
for programs for the diagnosis, treatment, and
control of such diseases, screening for such
diseases, and the counseling of persons with
such diseases;
(2) on the basis of the assessments and surveillance described in paragraph (1), develop
for use by the States programs which combine
in an effective manner diagnosis, treatment,
and control of such diseases, screening for
such diseases, and counseling of persons with
such diseases; and
(3) on the basis of the assessments and surveillance described in paragraph (1), provide
technical assistance to States to implement
the programs developed under paragraph (2)
and train appropriate personnel for such programs.
In carrying out this section, the Secretary may,
from funds allotted for use under section 702(a)
of this title, make grants to or contracts with
public or nonprofit private entities (including
grants
and
contracts
for
demonstration
projects).
(July 1, 1944, ch. 373, title XI, § 1107, as added
Pub. L. 95–626, title II, § 205(d)(1), Nov. 10, 1978, 92
Stat. 3584; amended Pub. L. 97–35, title XXI,
§ 2193(b)(5), Aug. 13, 1981, 95 Stat. 827.)
AMENDMENTS
1981—Pub. L. 97–35 substituted provisions relating to
allotments under section 702(a) of this title for provisions relating to appropriations under section 300b(b) of
this title.
EFFECTIVE DATE OF 1981 AMENDMENT, SAVINGS, AND
TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to amendment by Pub. L. 97–35, see section 2194 of Pub. L. 97–35, set out as a note under section 701 of this title.

§ 300b–7. Tourette Syndrome
(a) In general
The Secretary shall develop and implement
outreach programs to educate the public, health
care providers, educators and community based
organizations about the etiology, symptoms, diagnosis and treatment of Tourette Syndrome,
with a particular emphasis on children with
Tourette Syndrome. Such programs may be carried out by the Secretary directly and through
awards of grants or contracts to public or nonprofit private entities.
(b) Certain activities
Activities under subsection (a) of this section
shall include—
(1) the production and translation of educational materials, including public service
announcements;

§ 300b–8

(2) the development of training material for
health care providers, educators and community based organizations; and
(3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and in minority groups.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005.
(July 1, 1944, ch. 373, title XI, § 1108, as added
Pub. L. 106–310, div. A, title XXIII, § 2301, Oct. 17,
2000, 114 Stat. 1157.)
§ 300b–8. Improved newborn and child screening
for heritable disorders
(a) Authorization of grant program
From amounts appropriated under subsection
(j), the Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the
‘‘Administrator’’) and in consultation with the
Advisory Committee on Heritable Disorders in
Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award
grants to eligible entities to enable such entities—
(1) to enhance, improve or expand the ability
of State and local public health agencies to
provide screening, counseling, or health care
services to newborns and children having or at
risk for heritable disorders;
(2) to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn screening
and training in relevant and new technologies
in newborn screening and congenital, genetic,
and metabolic disorders;
(3) to develop and deliver educational programs (at appropriate literacy levels) about
newborn screening counseling, testing, followup, treatment, and specialty services to parents, families, and patient advocacy and support groups; and
(4) to establish, maintain, and operate a system to assess and coordinate treatment relating to congenital, genetic, and metabolic disorders.
(b) Eligible entity
In this section, the term ‘‘eligible entity’’
means—
(1) a State or a political subdivision of a
State;
(2) a consortium of 2 or more States or political subdivisions of States;
(3) a territory;
(4) a health facility or program operated by
or pursuant to a contract with or grant from
the Indian Health Service; or
(5) any other entity with appropriate expertise in newborn screening, as determined by
the Secretary.
(c) Approval factors
An application submitted for a grant under
subsection (a)(1) shall not be approved by the
Secretary unless the application contains assurances that the eligible entity has adopted and

§ 300b–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

implemented, is in the process of adopting and
implementing, or will use amounts received
under such grant to adopt and implement the
guidelines and recommendations of the Advisory
Committee that are adopted by the Secretary
and in effect at the time the grant is awarded or
renewed under this section, which shall include
the screening of each newborn for the heritable
disorders recommended by the Advisory Committee and adopted by the Secretary.
(d) Coordination
The Secretary shall take all necessary steps to
coordinate programs funded with grants received under this section and to coordinate with
existing newborn screening activities.
(e) Limitation
An eligible entity may not use amounts received under this section to—
(1) provide cash payments to or on behalf of
affected individuals;
(2) provide inpatient services;
(3) purchase land or make capital improvements to property; or
(4) provide for proprietary research or training.
(f) Voluntary participation
The participation by any individual in any
program or portion thereof established or operated with funds received under this section shall
be wholly voluntary and shall not be a prerequisite to eligibility for or receipt of any
other service or assistance from, or to participation in, another Federal or State program.
(g) Supplement not supplant
Funds appropriated under this section shall be
used to supplement and not supplant other Federal, State, and local public funds provided for
activities of the type described in this section.
(h) Publication
(1) In general
An application submitted under subsection
(c)(2) 1 of this section shall be made public by
the State in such a manner as to facilitate
comment from any person, including through
hearings and other methods used to facilitate
comments from the public.
(2) Comments
Comments received by the State after the
publication described in paragraph (1) shall be
addressed in the application submitted under
subsection (c)(2) 1 of this section.
(i) Technical assistance
The Secretary shall provide to entities receiving grants under subsection (a) of this section
such technical assistance as may be necessary
to ensure the quality of programs conducted
under this section.
(j) Authorization of appropriations
There are authorized to be appropriated—
(1) to provide grants for the purpose of carrying out activities under subsection (a)(1),
$15,000,000 for fiscal year 2009; 2 $15,187,500 for
1 See
2 So

References in Text note below.
in original. The semicolon probably should be a comma.

Page 910

fiscal year 2010, $15,375,000 for fiscal year 2011,
$15,562,500 for fiscal year 2012, and $15,750,000
for fiscal year 2013; and
(2) to provide grants for the purpose of carrying out activities under paragraphs (2), (3),
and (4) of subsection (a), $15,000,000 for fiscal
year 2009, $15,187,500 for fiscal year 2010,
$15,375,000 for fiscal year 2011, $15,562,500 for
fiscal year 2012, and $15,750,000 for fiscal year
2013.
(July 1, 1944, ch. 373, title XI, § 1109, as added
Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17,
2000, 114 Stat. 1164; amended Pub. L. 110–204, § 2,
Apr. 24, 2008, 122 Stat. 705; Pub. L. 110–237,
§ 1(a)(1), May 27, 2008, 122 Stat. 1556.)
REFERENCES IN TEXT
Subsection (c)(2) of this section, referred to in subsec.
(h)(1), (2), was struck out and a new subsec. (c) added by
Pub. L. 110–204, § 2(1), Apr. 24, 2008, 122 Stat. 705.
AMENDMENTS
2008—Subsecs. (a) to (c). Pub. L. 110–204, § 2(1), added
subsecs. (a) to (c) and struck out former subsecs. (a) to
(c) which provided for grants to promote screening,
counseling, or health care services to newborns and
children having or at risk for heritable disorders, enumerated permissible uses of grants, and set out grant
applicants’ eligibility requirements.
Subsecs. (d) to (i). Pub. L. 110–204, § 2(2), (3), added
subsec. (d) and redesignated former subsecs. (d) to (h)
as (e) to (i), respectively. Former subsec. (i) redesignated (j).
Subsec. (j). Pub. L. 110–237 added subsec. (j) and
struck out former subsec. (j). Prior to amendment, text
read as follows: ‘‘There is authorized to be appropriated—
‘‘(1) to provide grants for the purpose of carrying
activities under section (a)(1), $15,000,000 for fiscal
year 2008; $15,187,500 for fiscal year 2009, $15,375,000 for
fiscal year 2010, $15,562,500 for fiscal year 2011, and
$15,750,000 for fiscal year 2012; and
‘‘(2) to provide grant for the purpose of carrying out
activities under paragraphs (2), (3), and (4) of subsection (a), $15,000,000 for fiscal year 2008, $15,187,500
for fiscal year 2009, $15,375,000 for fiscal year 2010,
$15,562,500 for fiscal year 2011, and $15,750,000 for fiscal
year 2012.’’
Pub. L. 110–204, § 2(4), added subsec. (j) and struck out
former subsec. (j). Prior to amendment, text read as
follows: ‘‘There are authorized to be appropriated to
carry out this section such sums as may be necessary
for each of the fiscal years 2001 through 2005.’’
Pub. L. 110–204, § 2(2), redesignated subsec. (i) as (j).

§ 300b–9. Evaluating the effectiveness of newborn
and child screening programs
(a) In general
The Secretary shall award grants to eligible
entities to provide for the conduct of demonstration programs to evaluate the effectiveness of
screening, counseling or health care services in
reducing the morbidity and mortality caused by
heritable disorders in newborns and children.
(b) Demonstration programs
A demonstration program conducted under a
grant under this section shall be designed to
evaluate and assess, within the jurisdiction of
the entity receiving such grant—
(1) the effectiveness of screening, counseling,
testing or specialty services for newborns and
children at risk for heritable disorders in reducing the morbidity and mortality associated
with such disorders;

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(2) the effectiveness of screening, counseling,
testing or specialty services in accurately and
reliably diagnosing heritable disorders in newborns and children; or
(3) the availability of screening, counseling,
testing or specialty services for newborns and
children at risk for heritable disorders.
(c) Eligible entities
To be eligible to receive a grant under subsection (a) of this section an entity shall be a
State or political subdivision of a State, or a
consortium of two or more States or political
subdivisions of States.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $5,000,000 for fiscal year
2009, $5,062,500 for fiscal year 2010, $5,125,000 for
fiscal year 2011, $5,187,500 for fiscal year 2012, and
$5,250,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XI, § 1110, as added
Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17,
2000, 114 Stat. 1165; amended Pub. L. 110–204, § 3,
Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237,
§ 1(a)(2), May 27, 2008, 122 Stat. 1556.)
AMENDMENTS
2008—Subsec. (d). Pub. L. 110–237 substituted ‘‘2009,
$5,062,500 for fiscal year 2010, $5,125,000 for fiscal year
2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.’’ for ‘‘2008, $5,062,500 for fiscal year 2009,
$5,125,000 for fiscal year 2010, $5,187,500 for fiscal year
2011, and $5,250,000 for fiscal year 2012.’’
Pub. L. 110–204 added subsec. (d).

§ 300b–10. Advisory Committee on Heritable Disorders in Newborns and Children
(a) Establishment
The Secretary shall establish an advisory
committee to be known as the ‘‘Advisory Committee on Heritable Disorders in Newborns and
Children’’ (referred to in this section as the ‘‘Advisory Committee’’).
(b) Duties
The Advisory Committee shall—
(1) provide advice and recommendations to
the Secretary concerning grants and projects
awarded or funded under section 300b–8 of this
title;
(2) provide technical information to the Secretary for the development of policies and priorities for the administration of grants under
section 300b–8 of this title;
(3) make systematic evidence-based and
peer-reviewed recommendations that include
the heritable disorders that have the potential
to significantly impact public health for which
all newborns should be screened, including secondary conditions that may be identified as a
result of the laboratory methods used for
screening;
(4) develop a model decision-matrix for newborn screening expansion, including an evaluation of the potential public health impact of
such expansion, and periodically update the
recommended uniform screening panel, as appropriate, based on such decision-matrix;
(5) consider ways to ensure that all States
attain the capacity to screen for the conditions described in paragraph (3), and include in

§ 300b–10

such consideration the results of grant funding
under section 300b–8 of this title; and
(6) provide such recommendations, advice or
information as may be necessary to enhance,
expand or improve the ability of the Secretary
to reduce the mortality or morbidity from
heritable disorders, which may include recommendations, advice, or information dealing
with—
(A) follow-up activities, including those
necessary to achieve rapid diagnosis in the
short-term, and those that ascertain longterm case management outcomes and appropriate access to related services;
(B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, follow-up, and
treatment activities;
(C) diagnostic and other technology used
in screening;
(D) the availability and reporting of testing for conditions for which there is no existing treatment;
(E) conditions not included in the recommended uniform screening panel that are
treatable with Food and Drug Administration-approved products or other safe and effective treatments, as determined by scientific evidence and peer review;
(F) minimum standards and related policies and procedures used by State newborn
screening programs, such as language and
terminology used by State newborn screening programs to include standardization of
case definitions and names of disorders for
which newborn screening tests are performed;
(G) quality assurance, oversight, and evaluation of State newborn screening programs,
including ensuring that tests and technologies used by each State meet established
standards for detecting and reporting positive screening results;
(H) public and provider awareness and education;
(I) the cost and effectiveness of newborn
screening and medical evaluation systems
and intervention programs conducted by
State-based programs;
(J) identification of the causes of, public
health impacts of, and risk factors for heritable disorders; and
(K) coordination of surveillance activities,
including standardized data collection and
reporting, harmonization of laboratory definitions for heritable disorders and testing
results, and confirmatory testing and verification of positive results, in order to assess and enhance monitoring of newborn diseases.
(c) Membership
(1) In general
The Secretary shall appoint not to exceed 15
members to the Advisory Committee. In appointing such members, the Secretary shall
ensure that the total membership of the Advisory Committee is an odd number.
(2) Required members
The Secretary shall appoint to the Advisory
Committee under paragraph (1)—

§ 300b–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the Administrator of the Health Resources and Services Administration;
(B) the Director of the Centers for Disease
Control and Prevention;
(C) the Director of the National Institutes
of Health;
(D) the Director of the Agency for Healthcare Research and Quality;
(E) the Commissioner of the Food and
Drug Administration;
(F) medical, technical, or scientific professionals with special expertise in heritable
disorders, or in providing screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders;
(G) individuals with expertise in ethics and
infectious diseases who have worked and
published material in the area of newborn
screening;
(H) members of the public having special
expertise about or concern with heritable
disorders; and
(I) representatives from such Federal agencies, public health constituencies, and medical professional societies as determined to
be necessary by the Secretary, to fulfill the
duties of the Advisory Committee, as established under subsection (b) of this section.
(d) Decision on recommendations
(1) In general
Not later than 180 days after the Advisory
Committee issues a recommendation pursuant
to this section, the Secretary shall adopt or
reject such recommendation.
(2) Pending recommendations
The Secretary shall adopt or reject any recommendation issued by the Advisory Committee that is pending on April 24, 2008, by not
later than 180 days after April 24, 2008.
(3) Determinations to be made public
The Secretary shall publicize any determination on adopting or rejecting a recommendation of the Advisory Committee pursuant to this subsection, including the justification for the determination.
(e) Annual report
Not later than 3 years after April 24, 2008, and
each fiscal year thereafter, the Advisory Committee shall—
(1) publish a report on peer-reviewed newborn screening guidelines, including follow-up
and treatment, in the United States;
(2) submit such report to the appropriate
committees of Congress, the Secretary, the
Interagency Coordinating Committee established under section 300b–13 of this title, and
the State departments of health; and
(3) disseminate such report on as wide a
basis as practicable, including through posting
on the internet clearinghouse established
under section 300b–11 of this title.
(f) Continuation of operation of Committee
Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue to operate during the 5-year period beginning on April 24, 2008.

Page 912

(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $1,000,000 for fiscal year
2009, $1,012,500 for fiscal year 2010, $1,025,000 for
fiscal year 2011, $1,037,500 for fiscal year 2012, and
$1,050,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XI, § 1111, as added
Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17,
2000, 114 Stat. 1166; amended Pub. L. 110–204, § 4,
Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237,
§ 1(a)(3), (b)(2), May 27, 2008, 122 Stat. 1556, 1557.)
REFERENCES IN TEXT
Section 14 of the Federal Advisory Committee Act,
referred to in subsec. (f), is section 14 of Pub. L. 92–463,
which is set out in the Appendix to Title 5, Government
Organization and Employees.
AMENDMENTS
2008—Subsec. (b)(3) to (5). Pub. L. 110–204, § 4(1)(B), (C),
added pars. (3) to (5). Former par. (3) redesignated (6).
Subsec. (b)(6). Pub. L. 110–204, § 4(1)(A), (D), redesignated par. (3) as (6), substituted ‘‘, which may include
recommendations, advice, or information dealing
with—’’ for period at end, and added subpars. (A) to (K).
Subsec. (c)(2)(E) to (I). Pub. L. 110–204, § 4(2), as
amended by Pub. L. 110–237, § 1(b)(2), added subpars. (E)
and (G) and redesignated former subpars. (E), (F), and
(G) as (F), (H), and (I), respectively.
Subsec. (d). Pub. L. 110–204, § 4(3), added subsec. (d).
Subsec. (d)(2). Pub. L. 110–237, § 1(a)(3)(A), made technical amendment to reference in original act which appears in text as the first reference to April 24, 2008.
Subsecs. (e), (f). Pub. L. 110–237, § 1(a)(3)(B), (C), made
technical amendment to references in original act
which appear in text as references to April 24, 2008.
Pub. L. 110–204, § 4(3), added subsecs. (e) and (f).
Subsec. (g). Pub. L. 110–237, § 1(a)(3)(D), substituted
‘‘2009, $1,012,500 for fiscal year 2010, $1,025,000 for fiscal
year 2011, $1,037,500 for fiscal year 2012, and $1,050,000 for
fiscal year 2013.’’ for ‘‘2008, $1,012,500 for fiscal year 2009,
$1,025,000 for fiscal year 2010, $1,037,500 for fiscal year
2011, and $1,050,000 for fiscal year 2012.’’
Pub. L. 110–204, § 4(3), added subsec. (g).
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 300b–11. Clearinghouse of newborn screening
information
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this part as the ‘‘Administrator’’), in consultation with the Director
of the Centers for Disease Control and Prevention and the Director of the National Institutes
of Health, shall establish and maintain a central
clearinghouse of current educational and family

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

support and services information, materials, resources, research, and data on newborn screening to—
(1) enable parents and family members of
newborns, health professionals, industry representatives, and other members of the public
to increase their awareness, knowledge, and
understanding of newborn screening;
(2) increase awareness, knowledge, and understanding of newborn diseases and screening
services for expectant individuals and families; and
(3) maintain current data on quality indicators to measure performance of newborn
screening, such as false-positive rates and
other quality indicators as determined by the
Advisory Committee under section 300b–10 of
this title.
(b) Internet availability
The Secretary, acting through the Administrator, shall ensure that the clearinghouse described under subsection (a)—
(1) is available on the Internet;
(2) includes an interactive forum;
(3) is updated on a regular basis, but not less
than quarterly; and
(4) provides—
(A) links to Government-sponsored, nonprofit, and other Internet websites of laboratories that have demonstrated expertise in
newborn screening that supply researchbased information on newborn screening
tests currently available throughout the
United States;
(B) information about newborn conditions
and screening services available in each
State from laboratories certified under subpart 2 of part F of subchapter II, including
information about supplemental screening
that is available but not required, in the
State where the infant is born;
(C) current research on both treatable and
not-yet treatable conditions for which newborn screening tests are available;
(D) the availability of Federal funding for
newborn and child screening for heritable
disorders including grants authorized under
the Newborn Screening Saves Lives Act of
2008; and
(E) other relevant information as determined appropriate by the Secretary.
(c) Nonduplication
In developing the clearinghouse under this
section, the Secretary shall ensure that such
clearinghouse minimizes duplication and supplements, not supplants, existing information sharing efforts.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $2,500,000 for fiscal year
2009, $2,531,250 for fiscal year 2010, $2,562,500 for
fiscal year 2011, $2,593,750 for fiscal year 2012, and
$2,625,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XI, § 1112, as added
Pub. L. 110–204, § 5, Apr. 24, 2008, 122 Stat. 708;
amended Pub. L. 110–237, § 1(a)(4), May 27, 2008,
122 Stat. 1557.)
REFERENCES IN TEXT
The Newborn Screening Saves Lives Act of 2008, referred to in subsec. (b)(4)(D), is Pub. L. 110–204, Apr. 24,

§ 300b–13

2008, 122 Stat. 705, which enacted this section and sections 300b–12 to 300b–15 of this title, amended sections
300b–8 to 300b–10 of this title, and enacted provisions set
out as a note under section 201 of this title. For complete classification of this Act to the Code, see Short
Title of 2008 Amendment note set out under section 201
of this title and Tables.
AMENDMENTS
2008—Subsec. (b)(4)(D). Pub. L. 110–237, § 1(a)(4)(A),
substituted ‘‘2008’’ for ‘‘2007’’.
Subsec. (d). Pub. L. 110–237, § 1(a)(4)(B), substituted
‘‘2009, $2,531,250 for fiscal year 2010, $2,562,500 for fiscal
year 2011, $2,593,750 for fiscal year 2012, and $2,625,000 for
fiscal year 2013.’’ for ‘‘2008, $2,531,250 for fiscal year 2009,
$2,562,500 for fiscal year 2010, $2,593,750 for fiscal year
2011, and $2,625,000 for fiscal year 2012.’’

§ 300b–12. Laboratory quality
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention
and in consultation with the Advisory Committee on Heritable Disorders in Newborns and
Children established under section 300b–10 of
this title, shall provide for—
(1) quality assurance for laboratories involved in screening newborns and children for
heritable disorders, including quality assurance for newborn-screening tests, performance
evaluation services, and technical assistance
and technology transfer to newborn screening
laboratories to ensure analytic validity and
utility of screening tests; and
(2) appropriate quality control and other
performance test materials to evaluate the
performance of new screening tools.
(b) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $5,000,000
for fiscal year 2009, $5,062,500 for fiscal year 2010,
$5,125,000 for fiscal year 2011, $5,187,500 for fiscal
year 2012, and $5,250,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XI, § 1113, as added
Pub. L. 110–204, § 6, Apr. 24, 2008, 122 Stat. 710;
amended Pub. L. 110–237, § 1(a)(5), May 27, 2008,
122 Stat. 1557.)
AMENDMENTS
2008—Subsec. (b). Pub. L. 110–237 substituted ‘‘2009,
$5,062,500 for fiscal year 2010, $5,125,000 for fiscal year
2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.’’ for ‘‘2008, $5,062,500 for fiscal year 2009,
$5,125,000 for fiscal year 2010, $5,187,500 for fiscal year
2011, and $5,250,000 for fiscal year 2012.’’

§ 300b–13. Interagency Coordinating Committee
on Newborn and Child Screening
(a) Purpose
It is the purpose of this section to—
(1) assess existing activities and infrastructure, including activities on birth defects and
developmental disabilities authorized under
section 247b–4 of this title, in order to make
recommendations for programs to collect, analyze, and make available data on the heritable
disorders recommended by the Advisory Committee on Heritable Disorders in Newborns and
Children under section 300b–10 of this title, including data on the incidence and prevalence
of, as well as poor health outcomes resulting
from, such disorders; and

§ 300b–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) make recommendations for the establishment of regional centers for the conduct of applied epidemiological research on effective
interventions to promote the prevention of
poor health outcomes resulting from such disorders as well as providing information and
education to the public on such effective interventions.
(b) Establishment
The Secretary shall establish an Interagency
Coordinating Committee on Newborn and Child
Screening (referred to in this section as the
‘‘Interagency Coordinating Committee’’) to
carry out the purpose of this section.
(c) Composition
The Interagency Coordinating Committee
shall be composed of the Director of the Centers
for Disease Control and Prevention, the Administrator, the Director of the Agency for Healthcare Research and Quality, and the Director of
the National Institutes of Health, or their designees.
(d) Activities
The Interagency Coordinating Committee
shall—
(1) report to the Secretary and the appropriate committees of Congress on its recommendations related to the purpose described in
subsection (a); and
(2) carry out other activities determined appropriate by the Secretary.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated $1,000,000
for fiscal year 2009, $1,012,500 for fiscal year 2010,
$1,025,000 for fiscal year 2011, $1,037,500 for fiscal
year 2012, and $1,050,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XI, § 1114, as added
Pub. L. 110–204, § 6, Apr. 24, 2008, 122 Stat. 710;
amended Pub. L. 110–237, § 1(a)(6), May 27, 2008,
122 Stat. 1557.)
AMENDMENTS
2008—Subsec. (e). Pub. L. 110–237 substituted ‘‘2009,
$1,012,500 for fiscal year 2010, $1,025,000 for fiscal year
2011, $1,037,500 for fiscal year 2012, and $1,050,000 for fiscal year 2013.’’ for ‘‘2008, $1,012,500 for fiscal year 2009,
$1,025,000 for fiscal year 2010, $1,037,500 for fiscal year
2011, and $1,050,000 for fiscal year 2012.’’

§ 300b–14. National contingency plan for newborn screening
(a) In general
Not later than 180 days after April 24, 2008, the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention and
in consultation with the Administrator and
State departments of health (or related agencies), shall develop a national contingency plan
for newborn screening for use by a State, region,
or consortia 1 of States in the event of a public
health emergency.
(b) Contents
The contingency plan developed under subsection (a) shall include a plan for—
1 So

in original. Probably should be ‘‘consortium’’.

Page 914

(1) the collection and transport of specimens;
(2) the shipment of specimens to State newborn screening laboratories;
(3) the processing of specimens;
(4) the reporting of screening results to physicians and families;
(5) the diagnostic confirmation of positive
screening results;
(6) ensuring the availability of treatment
and management resources;
(7) educating families about newborn screening; and
(8) carrying out other activities determined
appropriate by the Secretary.
(July 1, 1944, ch. 373, title XI, § 1115, as added
Pub. L. 110–204, § 7, Apr. 24, 2008, 122 Stat. 711.)
§ 300b–15. Hunter Kelly Research Program
(a) Newborn screening activities
(1) In general
The Secretary, in conjunction with the Director of the National Institutes of Health and
taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating, and expanding research in newborn screening (to be
known as ‘‘Hunter Kelly Newborn Screening
Research Program’’) including—
(A) identifying, developing, and testing the
most promising new screening technologies,
in order to improve already existing screening tests, increase the specificity of newborn
screening, and expand the number of conditions for which screening tests are available;
(B) experimental treatments and disease
management strategies for additional newborn conditions, and other genetic, metabolic, hormonal, or functional conditions
that can be detected through newborn
screening for which treatment is not yet
available; and
(C) other activities that would improve
newborn screening, as identified by the Director.
(2) Additional newborn condition
For purposes of this subsection, the term
‘‘additional newborn condition’’ means any
condition that is not one of the core conditions recommended by the Advisory Committee and adopted by the Secretary.
(b) Funding
In carrying out the research program under
this section, the Secretary and the Director
shall ensure that entities receiving funding
through the program will provide assurances, as
practicable, that such entities will work in consultation with the appropriate State departments of health, and, as practicable, focus their
research on screening technology not currently
performed in the States in which the entities
are located, and the conditions on the uniform
screening panel (or the standard test existing on
the uniform screening panel).
(c) Reports
The Director is encouraged to include information about the activities carried out under
this section in the biennial report required

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

under section 403 of the National Institutes of
Health Reform Act of 2006.1 If such information
is included, the Director shall make such information available to be included on the Internet
Clearinghouse established under section 300b–11
of this title.
(d) Nonduplication
In carrying out programs under this section,
the Secretary shall minimize duplication and
supplement, not supplant, existing efforts of the
type carried out under this section.
(e) Peer review
Nothing in this section shall be construed to
interfere with the scientific peer-review process
at the National Institutes of Health.
(July 1, 1944, ch. 373, title XI, § 1116, as added
Pub. L. 110–204, § 7, Apr. 24, 2008, 122 Stat. 711;
amended Pub. L. 110–237, § 1(a)(7), May 27, 2008,
122 Stat. 1557.)
REFERENCES IN TEXT
Section 403 of the National Institutes of Health Reform Act of 2006, referred to in subsec. (c), probably
means section 403 of the Public Health Service Act, as
added by section 104(a)(3) of the National Institutes of
Health Reform Act of 2006, Pub. L. 109–482, which is
classified to section 283 of this title.
PRIOR PROVISIONS
Prior sections 300c to 300c–4 were repealed by Pub. L.
94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 407.
Section 300c, act July 1, 1944, ch. 373, title XI, § 1111,
as added Aug. 29, 1972, Pub. L. 92–414, § 3, 86 Stat. 650,
authorized Secretary to make grants and enter contracts with public and private entities for establishment of screening, treatment, and counseling programs
with respect to Cooley’s Anemia.
Section 300c–1, act July 1, 1944, ch. 373, title XI, § 1112,
as added Aug. 29, 1972, Pub. L. 92–414, § 3, 86 Stat. 651, required that any participation by an individual in any
Cooley’s Anemia programs should be on a purely voluntary basis.
Section 300c–2, act July 1, 1944, ch. 373, title XI, § 1113,
as added Aug. 29, 1972, Pub. L. 92–414, § 3, 86 Stat. 651,
provided for making of grant upon application to Secretary and listed certain requirements to be met by applicant.
Section 300c–3, act July 1, 1944, ch. 373, title XI, § 1114,
as added Aug. 29, 1972, Pub. L. 92–414, § 3, 86 Stat. 652,
authorized Secretary to establish a program with Public Health Service to provide for screening, counseling,
and treatment with respect to Cooley’s Anemia.
Section 300c–4, act July 1, 1944, ch. 373, title XI, § 1115,
as added Aug. 29, 1972, Pub. L. 92–414, § 3, 86 Stat. 652,
provided for Secretary’s submission of a report to
President for transmittal to Congress annually.
AMENDMENTS
2008—Subsec. (a)(1)(B). Pub. L. 110–237 substituted
‘‘, or’’ for ‘‘and or’’.

PART B—SUDDEN INFANT DEATH SYNDROME

§ 300c–12

amended Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(b)(1),
90 Stat. 409; S. Res. 4, Feb. 4, 1977; Aug. 1, 1977, Pub. L.
95–83, title III, § 306(a), 91 Stat. 389; Dec. 19, 1977, Pub. L.
95–215, § 8(a), 91 Stat. 1507; Nov. 8, 1978, Pub. L. 95–613,
§ 2, 92 Stat. 3094; Dec. 12, 1979, Pub. L. 96–142, title II,
§ 202, 93 Stat. 1070; H. Res. 549, Mar. 25, 1980; Aug. 13,
1981, Pub. L. 97–35, title XXI, § 2193(a)(1)(C), 95 Stat. 827,
related to sudden infant death syndrome counseling, information, educational, and statistical programs.
EFFECTIVE DATE OF 1981 AMENDMENT AND REPEAL,
SAVINGS, AND TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to the amendment and repeal of this section by Pub. L. 97–35, see section 2194 of Pub. L. 97–35,
set out as a note under section 701 of this title.

§ 300c–12. Sudden infant death syndrome research
From the sums appropriated to the Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, the Secretary
shall assure that there are applied to research of
the type described in subparagraphs (A) and (B)
of subsection (b)(1) 1 of this section such
amounts each year as will be adequate, given
the leads and findings then available from such
research, in order to make maximum feasible
progress toward identification of infants at risk
of sudden infant death syndrome and prevention
of sudden infant death syndrome.
(July 1, 1944, ch. 373, title XI, § 1122, as added
Pub. L. 96–142, title II, § 202, Dec. 12, 1979, 93 Stat.
1072; amended Pub. L. 99–158, § 3(a)(6), Nov. 20,
1985, 99 Stat. 879; Pub. L. 103–437, § 15(a)(1), Nov.
2, 1994, 108 Stat. 4591; Pub. L. 109–482, title I,
§ 104(b)(2)(B), Jan. 15, 2007, 120 Stat. 3693; Pub. L.
110–154, § 1(b)(10), Dec. 21, 2007, 121 Stat. 1827.)
REFERENCES IN TEXT
Subsection (b), referred to in text, was repealed by
Pub. L. 109–482, title I, § 104(b)(2)(B)(ii), Jan. 15, 2007, 120
Stat. 3693. Prior to repeal, subparagraphs (A) and (B) of
subsection (b)(1) read as follows:
‘‘(A) the (i) number of applications approved by the
Secretary in the fiscal year reported on for grants and
contracts under this chapter for research which relates
specifically to sudden infant death syndrome, (ii) total
amount requested under such applications, (iii) number
of such applications for which funds were provided in
such fiscal year, and (iv) total amount of such funds;
and
‘‘(B) the (i) number of applications approved by the
Secretary in such fiscal year for grants and contracts
under this chapter for research which relates generally
to sudden infant death syndrome, including high-risk
pregnancy and high-risk infancy research which directly relates to sudden infant death syndrome, (ii) relationship of the high-risk pregnancy and high-risk infancy research to sudden infant death syndrome, (iii)
total amount requested under such applications, (iv)
number of such applications for which funds were provided in such fiscal year, and (v) total amount of such
funds.’’

AMENDMENTS
1976—Pub. L. 94–278, title IV, § 403(b)(2), Apr. 22, 1976,
90 Stat. 409, redesignated part C heading as part B.

§ 300c–11. Repealed. Pub. L. 97–35, title XXI,
§ 2193(b)(1), Aug. 13, 1981, 95 Stat. 827
Section, act July 1, 1944, ch. 373, title XI, § 1121, as
added Apr. 22, 1974, Pub. L. 93–270, § 3(a), 88 Stat. 91;
1 See

References in Text note below.

AMENDMENTS
2007—Pub. L. 110–154 substituted ‘‘Eunice Kennedy
Shriver National Institute of Child Health and Human
Development’’ for ‘‘National Institute of Child Health
and Human Development’’.
Pub. L. 109–482 struck out subsec. (a) designation before ‘‘From the sums’’ and subsecs. (b) and (c) which related to annual report on data relating to applications
1 See

References in Text note below.

§ 300c–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for grants and contracts for research on sudden infant
death syndrome and annual estimate of amounts requested for such research.
1994—Subsecs. (b)(1), (c). Pub. L. 103–437 substituted
‘‘Energy and Commerce’’ for ‘‘Interstate and Foreign
Commerce’’.
1985—Subsec. (a). Pub. L. 99–158 struck out ‘‘under
section 289d of this title’’ before ‘‘, the Secretary’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

PART C—HEMOPHILIA PROGRAMS
AMENDMENTS
1976—Pub. L. 94–278, title IV, § 403(b)(2), Apr. 22, 1976,
90 Stat. 409, redesignated part D heading as part C.

§ 300c–21. Repealed. Pub. L. 97–35, title XXI,
§ 2193(b)(1), Aug. 13, 1981, 95 Stat. 827
Section, act July 1, 1944, ch. 373, title XI, § 1131, as
added July 29, 1975, Pub. L. 94–63, title VI, § 606, 89 Stat.
350; amended Aug. 1, 1977, Pub. L. 95–83, title III,
§ 306(b), 91 Stat. 389; Nov. 10, 1978, Pub. L. 95–626, title II,
§ 206(a), 92 Stat. 3584; Aug. 13, 1981, Pub. L. 97–35, title
XXI, § 2193(a)(1)(D), 95 Stat. 827, related to comprehensive hemophilia diagnostic and treatment centers.
EFFECTIVE DATE OF 1981 AMENDMENT AND REPEAL,
SAVINGS, AND TRANSITIONAL PROVISIONS
For effective date, savings, and transitional provisions relating to the amendment and repeal of this section by Pub. L. 97–35, see section 2194 of Pub. L. 97–35,
set out as a note under section 701 of this title.

§ 300c–22. Blood-separation centers
(a) Grants and contracts with public and nonprofit private entities for projects to develop
and expand existing facilities; definitions
The Secretary may make grants to and enter
into contracts with public and nonprofit private
entities for projects to develop and expand,
within existing facilities, blood-separation centers to separate and make available for distribution blood components to providers of blood
services and manufacturers of blood fractions.
For purposes of this section—
(1) the term ‘‘blood components’’ means
those constituents of whole blood which are
used for therapy and which are obtained by
physical separation processes which result in
licensed products such as red blood cells,
platelets, white blood cells, AHF-rich plasma,
fresh-frozen plasma, cryoprecipitate, and single unit plasma for infusion; and
(2) the term ‘‘blood fractions’’ means those
constituents of plasma which are used for
therapy and which are obtained by licensed
fractionation processes presently used in manufacturing which result in licensed products
such as normal serum albumin, plasma, protein fraction, prothrombin complex, fibrinogen, AHF concentrate, immune serum globulin, and hyperimmune globulins.
(b) Grants for alleviation of insufficient supplies
of blood fractions
In the event the Secretary finds that there is
an insufficient supply of blood fractions available to meet the needs for treatment of persons

Page 916

suffering from hemophilia, and that public and
other nonprofit private centers already engaged
in the production of blood fractions could alleviate such insufficiency with assistance under this
subsection, he may make grants not to exceed
$500,000 to such centers for the purposes of alleviating the insufficiency.
(c) Approval of application as prerequisite for
grant or contract; form, manner of submission, and contents of application
No grant or contract may be made under subsection (a) or (b) of this section unless an application therefor has been submitted to and approved by the Secretary. Such an application
shall be in such form, submitted in such manner, and contain such information as the Secretary shall by regulation prescribe.
(d) Nonapplicability of statutory provisions to
contracts
Contracts may be entered into under subsection (a) of this section without regard to section 3324(a) and (b) of title 31 and section 6101 of
title 41.
(e) Authorization of appropriations
For the purpose of making payments under
grants and contracts under subsections (a) and
(b) of this section, there are authorized to be appropriated $4,000,000 for fiscal year 1976,
$5,000,000 for the fiscal year ending September
30, 1977, $3,450,000 for the fiscal year ending September 30, 1978, $2,500,000 for the fiscal year ending September 30, 1979, $3,000,000 for the fiscal
year ending September 30, 1980, and $3,500,000 for
the fiscal year ending September 30, 1981.
(July 1, 1944, ch. 373, title XI, § 1132, as added
Pub. L. 94–63, title VI, § 606, July 29, 1975, 89 Stat.
351; amended Pub. L. 95–83, title III, § 306(c), Aug.
1, 1977, 91 Stat. 389; Pub. L. 95–626, title II,
§ 206(b), Nov. 10, 1978, 92 Stat. 3584.)
CODIFICATION
In subsec. (d), ‘‘section 3324(a) and (b) of title 31 and
section 6101 of title 41’’ substituted for ‘‘section 3648
and 3709 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C.
5)’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13, 1982,
96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
1978—Subsec. (e). Pub. L. 95–626 inserted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1979, 1980, and 1981.
1977—Subsec. (e). Pub. L. 95–83 substituted provisions
authorizing appropriations for fiscal years ending Sept.
30, 1977 and 1978, for prior such authorization for fiscal
year 1977.
EFFECTIVE DATE
Section effective July 1, 1975, see section 608 of Pub.
L. 94–63, set out as an Effective Date of 1975 Amendment note under section 247b of this title.
RICKY RAY HEMOPHILIA RELIEF FUND
Pub. L. 105–369, Nov. 12, 1998, 112 Stat. 3368, as amended by Pub. L. 106–554, § 1(a)(6) [title IX, § 932], Dec. 21,
2000, 114 Stat. 2763, 2763A–585, provided that:
‘‘SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
‘‘(a) SHORT TITLE.—This Act may be cited as the
‘Ricky Ray Hemophilia Relief Fund Act of 1998’.
‘‘(b) TABLE OF CONTENTS.—[Omitted.]

Page 917

TITLE 42—THE PUBLIC HEALTH AND WELFARE
‘‘TITLE I—HEMOPHILIA RELIEF FUND

‘‘SEC. 101. RICKY RAY HEMOPHILIA RELIEF FUND.
‘‘(a) ESTABLISHMENT.—There is established in the
Treasury of the United States a trust fund to be known
as the ‘Ricky Ray Hemophilia Relief Fund’, which shall
be administered by the Secretary of the Treasury.
‘‘(b) INVESTMENT OF AMOUNTS IN FUND.—Amounts in
the Fund shall be invested in accordance with section
9702 of title 31, United States Code, and any interest on
and proceeds from any such investment shall be credited to and become part of the Fund.
‘‘(c) AVAILABILITY OF FUND.—Amounts in the Fund
shall be available only for disbursement by the Secretary of Health and Human Services under section 103.
‘‘(d) TERMINATION.—The Fund shall terminate upon
the expiration of the 5-year period beginning on the
date of the enactment of this Act [Nov. 12, 1998]. If all
of the amounts in the Fund have not been expended by
the end of the 5-year period, investments of amounts in
the Fund shall be liquidated, the receipts of such liquidation shall be deposited in the Fund, and all funds
remaining in the Fund shall be deposited in the miscellaneous receipts account in the Treasury of the
United States.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to the Fund to carry out
this title $750,000,000. There is appropriated to the Fund
$475,000,000 for fiscal year 2001, to remain available
until expended.
‘‘SEC. 102. COMPASSIONATE PAYMENT RELATING
TO INDIVIDUALS WITH BLOOD-CLOTTING DISORDERS AND HIV.
‘‘(a) IN GENERAL.—If the conditions described in subsection (b) are met and if there are sufficient amounts
in the Fund to make each payment, the Secretary shall
make a single payment of $100,000 from the Fund to any
individual who has an HIV infection and who is described in one of the following paragraphs:
‘‘(1) The individual has any form of blood-clotting
disorder, such as hemophilia, and was treated with
antihemophilic factor at any time during the period
beginning on July 1, 1982, and ending on December 31,
1987.
‘‘(2) The individual—
‘‘(A) is the lawful spouse of an individual described in paragraph (1); or
‘‘(B) is the former lawful spouse of an individual
described in paragraph (1) and was the lawful
spouse of the individual at any time after a date,
within the period described in such subparagraph,
on which the individual was treated as described in
such paragraph and through medical documentation can assert reasonable certainty of transmission of HIV from individual described in paragraph (1).
‘‘(3) The individual acquired the HIV infection
through perinatal transmission from a parent who is
an individual described in paragraph (1) or (2).
‘‘(b) CONDITIONS.—The conditions described in this
subsection are, with respect to an individual, as follows:
‘‘(1) SUBMISSION OF MEDICAL DOCUMENTATION OF HIV
INFECTION.—The individual submits to the Secretary
written medical documentation that the individual
has an HIV infection.
‘‘(2) PETITION.—A petition for the payment is filed
with the Secretary by or on behalf of the individual.
‘‘(3) DETERMINATION.—The Secretary determines, in
accordance with section 103(b), that the petition
meets the requirements of this title.
‘‘SEC. 103. DETERMINATION AND PAYMENT.
‘‘(a) ESTABLISHMENT OF FILING PROCEDURES.—The
Secretary of Health and Human Services shall establish
procedures under which individuals may submit petitions for payment under this title. The procedures shall
include a requirement that each petition filed under
this Act include written medical documentation that
the relevant individual described in section 102(a)(1)

§ 300c–22

has (or had) a blood-clotting disorder, such as hemophilia, and was treated as described in such section.
‘‘(b) DETERMINATION.—For each petition filed under
this title, the Secretary shall determine whether the
petition meets the requirements of this title.
‘‘(c) PAYMENT.—
‘‘(1) IN GENERAL.—To the extent there are sufficient
amounts in the Fund to cover each payment, the Secretary shall pay, from the Fund, each petition that
the Secretary determines meets the requirements of
this title in the order received.
‘‘(2) PAYMENTS IN CASE OF DECEASED INDIVIDUALS.—
‘‘(A) IN GENERAL.—In the case of an individual referred to in section 102(a) who is deceased at the
time that payment is made under this section on a
petition filed by or on behalf of the individual, the
payment shall be made as follows:
‘‘(i) If the individual is survived by a spouse
who is living at the time of payment, the payment shall be made to such surviving spouse.
‘‘(ii) If the individual is not survived by a
spouse described in clause (i), the payment shall
be made in equal shares to all children of the individual who are living at the time of the payment.
‘‘(iii) If the individual is not survived by a person described in clause (i) or (ii), the payment
shall be made in equal shares to the parents of
the individual who are living at the time of the
payment.
‘‘(iv) If the individual is not survived by a person described in clause (i), (ii), or (iii), the payment shall revert back to the Fund.
‘‘(B) FILING OF PETITION BY SURVIVOR.—If an individual eligible for payment under section 102(a) dies
before filing a petition under this title, a survivor
of the individual may file a petition for payment
under this title on behalf of the individual if the
survivor may receive payment under subparagraph
(A).
‘‘(C) DEFINITIONS.—For purposes of this paragraph:
‘‘(i) The term ‘spouse’ means an individual who
was lawfully married to the relevant individual at
the time of death.
‘‘(ii) The term ‘child’ includes a recognized natural child, a stepchild who lived with the relevant
individual in a regular parent-child relationship,
and an adopted child.
‘‘(iii) The term ‘parent’ includes fathers and
mothers through adoption.
‘‘(3) TIMING OF PAYMENT.—The Secretary may not
make a payment on a petition under this title before
the expiration of the 120-day period beginning on the
date of the enactment of this Act [Nov. 12, 1998] or
after the expiration of the 5-year period beginning on
the date of the enactment of this Act.
‘‘(d) ACTION ON PETITIONS.—The Secretary shall complete the determination required by subsection (b) regarding a petition not later than 120 days after the date
the petition is filed under this title.
‘‘(e) HUMANITARIAN NATURE OF PAYMENT.—This Act
does not create or admit any claim of or on behalf of
the individual against the United States or against any
officer, employee, or agent thereof acting within the
scope of employment or agency that relate to an HIV
infection arising from treatment with antihemophilic
factor, at any time during the period beginning on July
1, 1982, and ending on December 31, 1987. A payment
under this Act shall, however, when accepted by or on
behalf of the individual, be in full satisfaction of all
such claims by or on behalf of that individual.
‘‘(f) ADMINISTRATIVE COSTS NOT PAID FROM FUND.—No
costs incurred by the Secretary in carrying out this
title may be paid from the Fund or set off against, or
otherwise deducted from, any payment made under subsection (c)(1).
‘‘(g) TERMINATION OF DUTIES OF SECRETARY.—The duties of the Secretary under this section shall cease
when the Fund terminates.

§ 300d

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(h) TREATMENT OF PAYMENTS UNDER OTHER LAWS.—
A payment under subsection (c)(1) to an individual—
‘‘(1) shall be treated for purposes of the Internal
Revenue Code of 1986 as damages described in section
104(a)(2) of such Code;
‘‘(2) shall not be included as income or resources for
purposes of determining the eligibility of the individual to receive benefits described in section
3803(c)(2)(C) of title 31, United States Code, or the
amount of such benefits, and such benefits shall not
be secondary to, conditioned upon reimbursement
from, or subject to any reduction because of receipt
of, any such payment; and
‘‘(3) shall not be treated as a third party payment
or payment in relation to a legal liability with respect to such benefits and shall not be subject
(whether by subrogation or otherwise) to recovery,
recoupment, reimbursement, or collection with respect to such benefits (including the Federal or State
governments or any entity that provides such benefits under a contract).
‘‘(i) REGULATORY AUTHORITY.—The Secretary may
issue regulations necessary to carry out this title.
‘‘(j) TIME OF ISSUANCE OF PROCEDURES.—The Secretary shall, through the promulgation of appropriate
regulations, guidelines, or otherwise, first establish the
procedures to carry out this title not later than 120
days after the date of the enactment of this Act [Nov.
12, 1998].
‘‘SEC. 104. LIMITATION ON TRANSFER OF RIGHTS
AND NUMBER OF PETITIONS.
‘‘(a) RIGHTS NOT ASSIGNABLE OR TRANSFERABLE.—Any
right under this title shall not be assignable or transferable.
‘‘(b) ONE PETITION WITH RESPECT TO EACH VICTIM.—
With respect to each individual described in paragraph
(1), (2), or (3) of section 102(a), the Secretary may not
make payment with respect to more than one petition
filed in respect to an individual.
‘‘SEC. 105. TIME LIMITATION.
‘‘The Secretary may not make any payment with respect to any petition filed under this title unless the
petition is filed within 3 years after the date of the enactment of this Act [Nov. 12, 1998].
‘‘SEC. 106. CERTAIN CLAIMS NOT AFFECTED BY
PAYMENT.
‘‘A payment made under section 103(c)(1) shall not be
considered as any form of compensation, or reimbursement for a loss, for purposes of imposing liability on
the individual receiving the payment, on the basis of
such receipt, to repay any insurance carrier for insurance payments or to repay any person on account of
worker’s compensation payments. A payment under
this title shall not affect any claim against an insurance carrier with respect to insurance or against any
person with respect to worker’s compensation.
‘‘SEC. 107. LIMITATION ON AGENT AND ATTORNEY
FEES.
‘‘Notwithstanding any contract, the representative of
an individual may not receive, for services rendered in
connection with the petition of an individual under this
title, more than 5 percent of a payment made under
this title on the petition. Any such representative who
violates this section shall be fined not more than
$50,000.
‘‘SEC. 108. DEFINITIONS.
‘‘For purposes of this title:
‘‘(1) The term ‘AIDS’ means acquired immune deficiency syndrome.
‘‘(2) The term ‘Fund’ means the Ricky Ray Hemophilia Relief Fund.
‘‘(3) The term ‘HIV’ means human immunodeficiency virus.

Page 918

‘‘(4) Unless otherwise provided, the term ‘Secretary’
means Secretary of Health and Human Services.
‘‘TITLE II—TREATMENT OF CERTAIN PAYMENTS IN HEMOPHILIA-CLOTTING-FACTOR SUIT UNDER THE SSI PROGRAM

‘‘SEC. 201. TREATMENT OF CERTAIN PAYMENTS IN
HEMOPHILIA-CLOTTING-FACTOR SUIT UNDER
THE MEDICAID AND SSI PROGRAMS.
‘‘(a) PRIVATE PAYMENTS.—
‘‘(1) IN GENERAL.—Notwithstanding any other provision of law, the payments described in paragraph (2)
shall not be considered income or resources in determining eligibility for, or the amount of—
‘‘(A) medical assistance under title XIX of the Social Security Act [section 1396 et seq. of this title];
or
‘‘(B) supplemental security income benefits under
title XVI of the Social Security Act [section 1381 et
seq. of this title].
‘‘(2) PRIVATE PAYMENTS DESCRIBED.—The payments
described in this subsection are—
‘‘(A) payments made from any fund established
pursuant to a class settlement in the case of Susan
Walker v. Bayer Corporation, et al., 96–C–5024 (N.D.
Ill.); and
‘‘(B) payments made pursuant to a release of all
claims in a case—
‘‘(i) that is entered into in lieu of the class settlement referred to in subparagraph (A); and
‘‘(ii) that is signed by all affected parties in
such case on or before the later of—
‘‘(I) December 31, 1997; or
‘‘(II) the date that is 270 days after the date
on which such release is first sent to the persons (or the legal representative of such persons) to whom the payment is to be made.
‘‘(b) GOVERNMENT PAYMENTS.—
‘‘(1) IN GENERAL.—Notwithstanding any other provision of law, the payments described in paragraph (2)
shall not be considered income or resources in determining eligibility for, or the amount of supplemental
security income benefits under title XVI of the Social
Security Act [section 1381 et seq. of this title].
‘‘(2) GOVERNMENT PAYMENTS DESCRIBED.—The payments described in this subsection are payments
made from the Fund established pursuant to section
101 of this Act.’’

SUBCHAPTER X—TRAUMA CARE
PART A—GENERAL AUTHORITY AND DUTIES OF
SECRETARY
§ 300d. Establishment
(a) In general
The Secretary shall, with respect to trauma
care—
(1) conduct and support research, training,
evaluations, and demonstration projects;
(2) foster the development of appropriate,
modern systems of such care through the sharing of information among agencies and individuals involved in the study and provision of
such care;
(3) collect, compile, and disseminate information on the achievements of, and problems
experienced by, State and local agencies and
private entities in providing trauma care and
emergency medical services and, in so doing,
give special consideration to the unique needs
of rural areas;
(4) provide to State and local agencies technical assistance to enhance each State’s capability to develop, implement, and sustain the
trauma care component of each State’s plan

Page 919

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for the provision of emergency medical services;
(5) sponsor workshops and conferences; and
(6) promote the collection and categorization of trauma data in a consistent and standardized manner.
(b) Grants, cooperative agreements, and contracts
The Secretary may make grants, and enter
into cooperative agreements and contracts, for
the purpose of carrying out subsection (a).
(July 1, 1944, ch. 373, title XII, § 1201, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2916;
amended Pub. L. 103–183, title VI, § 601(a), Dec.
14, 1993, 107 Stat. 2238; Pub. L. 104–146, § 12(b),
May 20, 1996, 110 Stat. 1373; Pub. L. 110–23, § 2,
May 3, 2007, 121 Stat. 90.)
PRIOR PROVISIONS
A prior section 300d, act July 1, 1944, ch. 373, title XII,
§ 1201, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a), 87
Stat. 594; amended Oct. 12, 1976, Pub. L. 94–484, title IX,
§ 905(b)(1), 90 Stat. 2325; Oct. 21, 1976, Pub. L. 94–573, §§ 2,
14(2), 90 Stat. 2709, 2718, defined terms applicable to this
subchapter, prior to repeal by Pub. L. 97–35, title IX,
§ 902(d)(1), (h), Aug. 13, 1981, 95 Stat. 560, 561, effective
Oct. 1, 1981.
A prior section 1201 of act July 1, 1944, ch. 373, title
XII, formerly § 1205, as added Nov. 16, 1973, Pub. L.
93–154, § 2(a), 87 Stat. 597, was classified to section 300d–4
of this title prior to repeal by Pub. L. 99–117, § 12(e),
Oct. 7, 1985, 99 Stat. 495.
AMENDMENTS

§ 300d–3

‘‘(4) barriers to the provision of prompt and appropriate emergency medical services exist in many
areas of the United States;
‘‘(5) few States and communities have developed
and implemented trauma care systems;
‘‘(6) many trauma centers have incurred substantial
uncompensated costs in providing trauma care, and
such costs have caused many such centers to cease
participation in trauma care systems; and
‘‘(7) the number of incidents of physical trauma in
the United States is a serious medical and social
problem, and the number of deaths resulting from
such incidents can be substantially reduced by improving the trauma-care components of the systems
for the provision of emergency medical services in
the United States.’’

§ 300d–1. Repealed. Pub. L. 103–183, title VI,
§ 601(b)(1), Dec. 14, 1993, 107 Stat. 2238; Pub.
L. 105–392, title IV, § 401(a)(1)(A), Nov. 13,
1998, 112 Stat. 3587
Section, act July 1, 1944, ch. 373, title XII, § 1202, as
added Nov. 16, 1990, Pub. L. 101–590, § 3, 104 Stat. 2916,
provided for establishment, membership, duties, etc., of
Advisory Council on Trauma Care Systems.
A prior section 300d–1, act July 1, 1944, ch. 373, title
XII, § 1202, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a),
87 Stat. 595; amended Oct. 21, 1976, Pub. L. 94–573, § 3, 90
Stat. 2709; Dec. 12, 1979, Pub. L. 96–142, title I, § 103, 93
Stat. 1067, set forth provisions relating to grants and
contracts for feasibility studies and planning, prior to
repeal by Pub. L. 97–35, title IX, § 902(d)(1), (h), Aug. 13,
1981, 95 Stat. 560, 561, effective Oct. 1, 1981.

§ 300d–2. Repealed. Pub. L. 110–23, § 3(1), May 3,
2007, 121 Stat. 90

2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section required the Secretary to provide support to trauma care, authorized the Secretary
to make grants and enter into agreements for such support, and required the Administrator of the Health Resources and Services Administration to ensure that the
Division of Trauma and Emergency Medical Systems
administered this subchapter.
1996—Subsec. (a). Pub. L. 104–146, in introductory provisions, substituted ‘‘The Secretary shall,’’ for ‘‘The
Secretary, acting through the Administrator of the
Health Resources and Services Administration, shall,’’.
1993—Subsec. (a). Pub. L. 103–183, § 601(a)(1), in introductory provisions inserted ‘‘, acting through the Administrator of the Health Resources and Services Administration,’’ after ‘‘Secretary’’.
Subsec. (c). Pub. L. 103–183, § 601(a)(2), added subsec.
(c).

Section, act July 1, 1944, ch. 373, title XII, § 1202, formerly § 1203, as added Pub. L. 101–590, § 3, Nov. 16, 1990,
104 Stat. 2917; renumbered § 1202, Pub. L. 103–183, title
VI, § 601(b)(2), Dec. 14, 1993, 107 Stat. 2238; amended Pub.
L. 105–392, title IV, § 401(a)(1)(A), Nov. 13, 1998, 112 Stat.
3587, required the Secretary to provide for the establishment and operation of a National Clearinghouse on
Trauma Care and Emergency Medical Services.
A prior section 300d–2, act July 1, 1944, ch. 373, title
XII, § 1203, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a),
87 Stat. 596; amended Oct. 21, 1976, Pub. L. 94–573, § 4, 90
Stat. 2710; Nov. 10, 1978, Pub. L. 95–626, title II, § 210(a),
92 Stat. 3588; July 10, 1979, Pub. L. 96–32, § 7(l), 93 Stat.
84, set forth provisions relating to grants and contracts
for establishing and initial operation of emergency
medical services systems, prior to repeal by Pub. L.
97–35, title IX, § 902(d)(1), (h), Aug. 13, 1981, 95 Stat. 560,
561, effective Oct. 1, 1981.

EFFECTIVE DATE OF 1996 AMENDMENT

§ 300d–3. Establishment of programs for improving trauma care in rural areas

Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.
CONGRESSIONAL STATEMENT OF FINDINGS
Section 2 of Pub. L. 101–590 provided that: ‘‘The Congress finds that—
‘‘(1) the Federal Government and the governments
of the States have established a history of cooperation in the development, implementation, and monitoring of integrated, comprehensive systems for the
provision of emergency medical services throughout
the United States;
‘‘(2) physical trauma is the leading cause of death
of Americans between the ages of 1 and 44 and is the
third leading cause of death in the general population
of the United States;
‘‘(3) physical trauma in the United States results in
an aggregate annual cost of $180,000,000,000 in medical
expenses, insurance, lost wages, and property damage;

(a) In general
The Secretary may make grants to public and
nonprofit private entities for the purpose of carrying out research and demonstration projects
with respect to improving the availability and
quality of emergency medical services in rural
areas—
(1) by developing innovative uses of communications technologies and the use of new
communications technology;
(2) by developing model curricula, such as
advanced trauma life support, for training
emergency medical services personnel, including first responders, emergency medical technicians, emergency nurses and physicians, and
paramedics—
(A) in the assessment, stabilization, treatment, preparation for transport, and resus-

§ 300d–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

citation of seriously injured patients, with
special attention to problems that arise during long transports and to methods of minimizing delays in transport to the appropriate facility; and
(B) in the management of the operation of
the emergency medical services system;
(3) by making training for original certification, and continuing education, in the provision and management of emergency medical
services more accessible to emergency medical
personnel in rural areas through telecommunications, home studies, providing teachers and
training at locations accessible to such personnel, and other methods;
(4) by developing innovative protocols and
agreements to increase access to prehospital
care and equipment necessary for the transportation of seriously injured patients to the
appropriate facilities;
(5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
(6) by increasing communication and coordination with State trauma systems.
(b) Special consideration for certain rural areas
In making grants under subsection (a), the
Secretary shall give special consideration to any
applicant for the grant that will provide services
under the grant in any rural area identified by
a State under section 300d–14(d)(1) of this title.
(c) Requirement of application
The Secretary may not make a grant under
subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances,
and information as the Secretary determines to
be necessary to carry out this section.
(July 1, 1944, ch. 373, title XII, § 1202, formerly
§ 1204, as added Pub. L. 101–590, § 3, Nov. 16, 1990,
104 Stat. 2918; renumbered § 1203 and amended
Pub. L. 103–183, title VI, § 601(b)(2), (f)(1), Dec. 14,
1993, 107 Stat. 2238, 2239; Pub. L. 105–392, title IV,
§ 401(a)(1), Nov. 13, 1998, 112 Stat. 3587; renumbered § 1202 and amended Pub. L. 110–23, §§ 3(2), 4,
May 3, 2007, 121 Stat. 90, 91.)
PRIOR PROVISIONS
A prior section 300d–3, act July 1, 1944, ch. 373, title
XII, § 1204, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a),
87 Stat. 597; amended Oct. 21, 1976, Pub. L. 94–573, § 5, 90
Stat. 2711; Nov. 10, 1978, Pub. L. 95–626, title II, § 210(b),
92 Stat. 3588; Dec. 12, 1979, Pub. L. 96–142, title I, § 104(a),
(b), 93 Stat. 1067, 1068, set forth provisions relating to
grants and contracts for expansion and improvements,
prior to repeal by Pub. L. 97–35, title IX, § 902(d)(1), (h),
Aug. 13, 1981, 95 Stat. 560, 561, effective Oct. 1, 1981.
A prior section 1202 of act July 1, 1944, was classified
to section 300d–2 of this title prior to repeal by Pub. L.
110–23.
Another prior section 1202 of act July 1, 1944, was
classified to section 300d–1 of this title prior to repeal
by Pub. L. 103–183.
Another prior section 1202 of act July 1, 1944, was
classified to section 300d–6 of this title prior to repeal
by Pub. L. 99–117.
AMENDMENTS
2007—Pub. L. 110–23, § 4, amended section generally.
Prior to amendment, section provided for establish-

Page 920

ment of programs for improving trauma care in rural
areas.
1998—Pub. L. 105–392, § 401(a)(1), made technical corrections to directory language of Pub. L. 103–183,
§ 601(b)(2), which renumbered this section, and to directory language of Pub. L. 103–183, § 601(f)(1). See 1993
Amendment note below.
1993—Subsec. (c). Pub. L. 103–183, § 601(f)(1), as amended by Pub. L. 105–392, § 401(a)(1)(B), inserted ‘‘determines to be necessary to carry out this section’’ before
period at end.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.

§ 300d–4. Emergency medical services
(a) 1 Federal Interagency Committee on Emergency Medical Services
(1) Establishment
The Secretary of Transportation, the Secretary of Health and Human Services, and the
Secretary of Homeland Security, acting
through the Under Secretary for Emergency
Preparedness and Response, shall establish a
Federal Interagency Committee on Emergency
Medical Services.
(2) Membership
The Interagency Committee shall consist of
the following officials, or their designees:
(A) The Administrator, National Highway
Traffic Safety Administration.
(B) The Director, Preparedness Division,
Directorate of Emergency Preparedness and
Response of the Department of Homeland
Security.
(C) The Administrator, Health Resources
and Services Administration, Department of
Health and Human Services.
(D) The Director, Centers for Disease Control and Prevention, Department of Health
and Human Services.
(E) The Administrator, United States Fire
Administration, Directorate of Emergency
Preparedness and Response of the Department of Homeland Security.
(F) The Administrator, Centers for Medicare and Medicaid Services, Department of
Health and Human Services.
(G) The Under Secretary of Defense for
Personnel and Readiness.
(H) The Director, Indian Health Service,
Department of Health and Human Services.
(I) The Chief, Wireless Telecommunications Bureau, Federal Communications Commission.
(J) A representative of any other Federal
agency appointed by the Secretary of Transportation or the Secretary of Homeland Security through the Under Secretary for
Emergency Preparedness and Response, in
consultation with the Secretary of Health
and Human Services, as having a significant
role in relation to the purposes of the Interagency Committee.
(K) A State emergency medical services director appointed by the Secretary.
1 So

in original. No subsec. (b) has been enacted.

Page 921

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Purposes
The purposes of the Interagency Committee
are as follows:
(A) To ensure coordination among the Federal agencies involved with State, local,
tribal, or regional emergency medical services and 9–1–1 systems.
(B) To identify State, local, tribal, or regional emergency medical services and 9–1–1
needs.
(C) To recommend new or expanded programs, including grant programs, for improving State, local, tribal, or regional
emergency medical services and implementing improved emergency medical services
communications
technologies,
including
wireless 9–1–1.
(D) To identify ways to streamline the
process through which Federal agencies support State, local, tribal or regional emergency medical services.
(E) To assist State, local, tribal or regional emergency medical services in setting
priorities based on identified needs.
(F) To advise, consult, and make recommendations on matters relating to the implementation of the coordinated State emergency medical services programs.
(4) Administration
The Administrator of the National Highway
Traffic Safety Administration, in cooperation
with the Administrator of the Health Resources and Services Administration of the
Department of Health and Human Services
and the Director of the Preparedness Division,
Directorate of Emergency Preparedness and
Response of the Department of Homeland Security, shall provide administrative support to
the Interagency Committee, including scheduling meetings, setting agendas, keeping minutes and records, and producing reports.
(5) Leadership
The members of the Interagency Committee
shall select a chairperson of the Committee
each year.
(6) Meetings
The Interagency Committee shall meet as
frequently as is determined necessary by the
chairperson of the Committee.
(7) Annual reports
The Interagency Committee shall prepare an
annual report to Congress regarding the Committee’s activities, actions, and recommendations.
(Pub. L. 109–59, title X, § 10202, Aug. 10, 2005, 119
Stat. 1932.)
CODIFICATION
Section was enacted as part of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users or SAFETEA–LU, and not as part of the
Public Health Service Act which comprises this chapter.
PRIOR PROVISIONS
A prior section 300d–4, act July 1, 1944, ch. 373, title
XII, § 1201, formerly § 1205, as added Nov. 16, 1973, Pub.
L. 93–154, § 2(a), 87 Stat. 597; amended Oct. 21, 1976, Pub.

§ 300d–5

L. 94–573, § 6, 90 Stat. 2713, renumbered § 1201 and amended Aug. 13, 1981, Pub. L. 97–35, title IX, § 902(d)(1), (3), 95
Stat. 560, authorized Secretary to make grants and
enter into contracts to support research in emergency
medical techniques, methods, devices, and delivery,
prior to repeal by Pub. L. 99–117, § 12(e), Oct. 7, 1985, 99
Stat. 495.

§ 300d–5. Competitive grants for trauma systems
for the improvement of trauma care
(a) In general
The Secretary, acting through the Assistant
Secretary for Preparedness and Response, may
make grants to States, political subdivisions, or
consortia of States or political subdivisions for
the purpose of improving access to and enhancing the development of trauma care systems.
(b) Use of funds
The Secretary may make a grant under this
section only if the applicant agrees to use the
grant—
(1) to integrate and broaden the reach of a
trauma care system, such as by developing innovative protocols to increase access to
prehospital care;
(2) to strengthen, develop, and improve an
existing trauma care system;
(3) to expand communications between the
trauma care system and emergency medical
services through improved equipment or a
telemedicine system;
(4) to improve data collection and retention;
or
(5) to increase education, training, and technical assistance opportunities, such as training and continuing education in the management of emergency medical services accessible
to emergency medical personnel in rural areas
through telehealth, home studies, and other
methods.
(c) Preference
In selecting among States, political subdivisions, and consortia of States or political subdivisions for purposes of making grants under
this section, the Secretary shall give preference
to applicants that—
(1) have developed a process, using national
standards, for designating trauma centers;
(2) recognize protocols for the delivery of seriously injured patients to trauma centers;
(3) implement a process for evaluating the
performance of the trauma system; and
(4) agree to participate in information systems described in section 300d–3 of this title by
collecting, providing, and sharing information.
(d) Priority
In making grants under this section, the Secretary shall give priority to applicants that will
use the grants to focus on improving access to
trauma care systems.
(e) Special consideration
In awarding grants under this section, the Secretary shall give special consideration to
projects that demonstrate strong State or local
support, including availability of non-Federal
contributions.
(July 1, 1944, ch. 373, title XII, § 1203, as added
Pub. L. 110–23, § 5, May 3, 2007, 121 Stat. 91;

§ 300d–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amended Pub. L. 111–148, title III, § 3504(a)(1),
Mar. 23, 2010, 124 Stat. 518.)
PRIOR PROVISIONS
A prior section 300d–5, act July 1, 1944, ch. 373, title
XII, § 1206, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a),
87 Stat. 598; amended Oct. 21, 1976, Pub. L. 94–573, §§ 7,
14(2), 90 Stat. 2713, 2718; Nov. 10, 1978, Pub. L. 95–626,
title II, § 210(c), 92 Stat. 3588; Dec. 12, 1979, Pub. L.
96–142, title I, § 104(c), 93 Stat. 1068, set forth general
provisions respecting grants and contracts, prior to repeal by Pub. L. 97–35, title IX, § 902(d)(1), (h), Aug. 13,
1981, 95 Stat. 560, 561, effective Oct. 1, 1981.
A prior section 1203 of act July 1, 1994, was renumbered section 1202 and is classified to section 300d–3 of
this title.
Another prior section 1203 of act July 1, 1994, was renumbered section 1202 and was classified to section
300d–2 of this title prior to repeal by Pub. L. 110–23.
AMENDMENTS
2010—Pub. L. 111–148 inserted ‘‘for trauma systems’’
after ‘‘grants’’ in section catchline and substituted
‘‘Assistant Secretary for Preparedness and Response’’
for ‘‘Administrator of the Health Resources and Services Administration’’ in subsec. (a).

§ 300d–6. Competitive grants for regionalized systems for emergency care response
(a) In general
The Secretary, acting through the Assistant
Secretary for Preparedness and Response, shall
award not fewer than 4 multiyear contracts or
competitive grants to eligible entities to support pilot projects that design, implement, and
evaluate innovative models of regionalized,
comprehensive, and accountable emergency care
and trauma systems.
(b) Eligible entity; region
In this section:
(1) Eligible entity
The term ‘‘eligible entity’’ means—
(A) a State or a partnership of 1 or more
States and 1 or more local governments; or
(B) an Indian tribe (as defined in section
1603 of title 25) or a partnership of 1 or more
Indian tribes.
(2) Region
The term ‘‘region’’ means an area within a
State, an area that lies within multiple
States, or a similar area (such as a multicounty area), as determined by the Secretary.
(3) Emergency services
The term ‘‘emergency services’’ includes
acute, prehospital, and trauma care.
(c) Pilot projects
The Secretary shall award a contract or grant
under subsection (a) to an eligible entity that
proposes a pilot project to design, implement,
and evaluate an emergency medical and trauma
system that—
(1) coordinates with public health and safety
services, emergency medical services, medical
facilities, trauma centers, and other entities
in a region to develop an approach to emergency medical and trauma system access
throughout the region, including 9–1–1 Public
Safety Answering Points and emergency medical dispatch;

Page 922

(2) includes a mechanism, such as a regional
medical direction or transport communications system, that operates throughout the region to ensure that the patient is taken to the
medically appropriate facility (whether an initial facility or a higher-level facility) in a
timely fashion;
(3) allows for the tracking of prehospital and
hospital resources, including inpatient bed capacity, emergency department capacity, trauma center capacity, on-call specialist coverage, ambulance diversion status, and the coordination of such tracking with regional
communications and hospital destination decisions; and
(4) includes a consistent region-wide
prehospital, hospital, and interfacility data
management system that—
(A) submits data to the National EMS Information System, the National Trauma
Data Bank, and others;
(B) reports data to appropriate Federal
and State databanks and registries; and
(C) contains information sufficient to
evaluate key elements of prehospital care,
hospital destination decisions, including initial hospital and interfacility decisions, and
relevant health outcomes of hospital care.
(d) Application
(1) In general
An eligible entity that seeks a contract or
grant described in subsection (a) shall submit
to the Secretary an application at such time
and in such manner as the Secretary may require.
(2) Application information
Each application shall include—
(A) an assurance from the eligible entity
that the proposed system—
(i) has been coordinated with the applicable State Office of Emergency Medical
Services (or equivalent State office);
(ii) includes consistent indirect and direct medical oversight of prehospital, hospital, and interfacility transport throughout the region;
(iii) coordinates prehospital treatment
and triage, hospital destination, and interfacility transport throughout the region;
(iv) includes a categorization or designation system for special medical facilities
throughout the region that is integrated
with transport and destination protocols;
(v) includes a regional medical direction,
patient tracking, and resource allocation
system that supports day-to-day emergency care and surge capacity and is integrated with other components of the national and State emergency preparedness
system; and
(vi) addresses pediatric concerns related
to integration, planning, preparedness, and
coordination of emergency medical services for infants, children and adolescents;
and
(B) such other information as the Secretary may require.

Page 923

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Requirement of matching funds
(1) In general
The Secretary may not make a grant under
this section unless the State (or consortia of
States) involved agrees, with respect to the
costs to be incurred by the State (or consortia)
in carrying out the purpose for which such
grant was made, to make available non-Federal contributions (in cash or in kind under
paragraph (2)) toward such costs in an amount
equal to not less than $1 for each $3 of Federal
funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.
(2) Non-Federal contributions
Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly
evaluated, including equipment or services
(and excluding indirect or overhead costs).
Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the
amount of such non-Federal contributions.
(f) Priority
The Secretary shall give priority for the
award of the contracts or grants described in
subsection (a) to any eligible entity that serves
a population in a medically underserved area (as
defined in section 254b(b)(3) of this title).
(g) Report
Not later than 90 days after the completion of
a pilot project under subsection (a), the recipient of such contract or grant described in 1 shall
submit to the Secretary a report containing the
results of an evaluation of the program, including an identification of—
(1) the impact of the regional, accountable
emergency care and trauma system on patient
health outcomes for various critical care categories, such as trauma, stroke, cardiac emergencies, neurological emergencies, and pediatric emergencies;
(2) the system characteristics that contribute to the effectiveness and efficiency of the
program (or lack thereof);
(3) methods of assuring the long-term financial sustainability of the emergency care and
trauma system;
(4) the State and local legislation necessary
to implement and to maintain the system;
(5) the barriers to developing regionalized,
accountable emergency care and trauma systems, as well as the methods to overcome such
barriers; and
(6) recommendations on the utilization of
available funding for future regionalization efforts.
(h) Dissemination of findings
The Secretary shall, as appropriate, disseminate to the public and to the appropriate Committees of the Congress, the information contained in a report made under subsection (g).
(July 1, 1944, ch. 373, title XII, § 1204, as added
Pub. L. 111–148, title III, § 3504(a)(2), Mar. 23, 2010,
124 Stat. 518.)
1 So

in original.

§ 300d–11

PRIOR PROVISIONS
A prior section 300d–6, act July 1, 1944, ch. 373, title
XII, § 1202, formerly § 1207, as added Nov. 16, 1973, Pub.
L. 93–154, § 2(a), 87 Stat. 602; amended Oct. 21, 1976, Pub.
L. 94–573, § 8, 90 Stat. 2714; Nov. 10, 1978, Pub. L. 95–626,
title II, § 210(d), 92 Stat. 3588; Dec. 12, 1979, Pub. L.
96–142, title I, § 105, 93 Stat. 1068; renumbered § 1202 and
amended Aug. 13, 1981, Pub. L. 97–35, title IX, § 902(d)(1),
(4), 95 Stat. 560, authorized appropriations for purposes
of this subchapter, prior to repeal by Pub. L. 99–117,
§ 12(e), Oct. 7, 1985, 99 Stat. 495.
A prior section 1204 of act July 1, 1944, was classified
to section 300d–3 of this title prior to repeal by Pub. L.
97–35.
Prior sections 300d–7 to 300d–9 were repealed by Pub.
L. 97–35, title IX, § 902(d)(1), (h), Aug. 13, 1981, 95 Stat.
560, 561, effective Oct. 1, 1981.
Section 300d–7, act July 1, 1944, ch. 373, title XII,
§ 1208, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a), 87
Stat. 602; amended Oct. 12, 1976, Pub. L. 94–484, title
VIII, § 801(b), 90 Stat. 2322; Oct. 21, 1976, Pub. L. 94–573,
§ 9, 90 Stat. 2715, set forth provisions relating to administration of emergency medical services administrative
unit.
Section 300d–8, act July 1, 1944, ch. 373, title XII,
§ 1209, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a), 87
Stat. 602; amended Oct. 21, 1976, Pub. L. 94–573, § 10, 90
Stat. 2716; Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93
Stat. 695; Dec. 12, 1979, Pub. L. 96–142, title I, § 106, 93
Stat. 1069, related to Interagency Committee on Emergency Medical Services.
Section 300d–9, act July 1, 1944, ch. 373, title XII,
§ 1210, as added Nov. 16, 1973, Pub. L. 93–154, § 2(a), 87
Stat. 603; amended Oct. 21, 1976, Pub. L. 94–573, § 11, 90
Stat. 2717, related to annual report to Congress.

PART B—FORMULA GRANTS WITH RESPECT TO
MODIFICATIONS OF STATE PLANS
§ 300d–11. Establishment of program
(a) Requirement of allotments for States
The Secretary shall for each fiscal year make
an allotment for each State in an amount determined in accordance with section 300d–18 of this
title. The Secretary shall make payments, as
grants, each fiscal year to each State from the
allotment for the State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant to section
300d–17 of this title.
(b) Purpose
Except as provided in section 300d–33 1 of this
title, the Secretary may not make payments
under this part for a fiscal year unless the State
involved agrees that, with respect to the trauma
care component of the State plan for the provision of emergency medical services, the payments will be expended only for the purpose of
developing, implementing, and monitoring the
modifications to such component described in
section 300d–13 of this title.
(July 1, 1944, ch. 373, title XII, § 1211, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2919.)
REFERENCES IN TEXT
Section 300d–33 of this title, referred to in subsec. (b),
was repealed by Pub. L. 103–183, title VI, § 601(e), Dec.
14, 1993, 107 Stat. 2239.
1 See

References in Text note below.

§ 300d–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300d–12. Requirement of matching funds for fiscal years subsequent to first fiscal year of
payments
(a) Non-Federal contributions
(1) In general
The Secretary may not make payments
under section 300d–11(a) of this title unless the
State involved agrees, with respect to the
costs described in paragraph (2), to make
available non-Federal contributions (in cash
or in kind under subsection (b)(1)) toward such
costs in an amount that—
(A) for the second and third fiscal years of
such payments to the State, is not less than
$1 for each $1 of Federal funds provided in
such payments for such fiscal years; and
(B) for the fourth and subsequent fiscal
years of such payments to the State, is not
less than $2 for each $1 of Federal funds provided in such payments for such fiscal years.
(2) Program costs
The costs referred to in paragraph (1) are—
(A) the costs to be incurred by the State in
carrying out the purpose described in section 300d–11(b) of this title; or
(B) the costs of improving the quality and
availability of emergency medical services
in rural areas of the State.
(3) Initial year of payments
The Secretary may not require a State to
make non-Federal contributions as a condition of receiving payments under section
300d–11(a) of this title for the first fiscal year
of such payments to the State.
(b) Determination of amount of non-Federal contribution
With respect to compliance with subsection (a)
as a condition of receiving payments under section 300d–11(a) of this title—
(1) a State may make the non-Federal contributions required in such subsection in cash
or in kind, fairly evaluated, including plant,
equipment, or services; and
(2) the Secretary may not, in making a determination of the amount of non-Federal contributions, include amounts provided by the
Federal Government or services assisted or
subsidized to any significant extent by the
Federal Government.
(July 1, 1944, ch. 373, title XII, § 1212, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2919;
amended Pub. L. 103–183, title VI, § 601(f)(2), Dec.
14, 1993, 107 Stat. 2239; Pub. L. 110–23, § 6, May 3,
2007, 121 Stat. 92.)
AMENDMENTS
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to requirement of
matching funds for fiscal years subsequent to first fiscal year of payments.
1993—Subsec. (a)(2)(A). Pub. L. 103–183 substituted
‘‘section 300d–11(b)’’ for ‘‘section 300d–11(c)’’.

§ 300d–13. Requirements with respect to carrying
out purpose of allotments
(a) Trauma care modifications to State plan for
emergency medical services
With respect to the trauma care component of
a State plan for the provision of emergency

Page 924

medical services, the modifications referred to
in section 300d–11(b) of this title are such modifications to the State plan as may be necessary
for the State involved to ensure that the plan
provides for access to the highest possible quality of trauma care, and that the plan—
(1) specifies that the modifications required
pursuant to paragraphs (2) through (11) will be
implemented by the principal State agency
with respect to emergency medical services or
by the designee of such agency;
(2) specifies a public or private entity that
will designate trauma care regions and trauma
centers in the State;
(3) subject to subsection (b), contains national standards and requirements of the
American College of Surgeons or another appropriate entity for the designation of level I
and level II trauma centers, and in the case of
rural areas level III trauma centers (including
trauma centers with specified capabilities and
expertise in the care of pediatric trauma patients), by such entity, including standards
and requirements for—
(A) the number and types of trauma patients for whom such centers must provide
care in order to ensure that such centers will
have sufficient experience and expertise to
be able to provide quality care for victims of
injury;
(B) the resources and equipment needed by
such centers; and
(C) the availability of rehabilitation services for trauma patients;
(4) contains standards and requirements for
the implementation of regional trauma care
systems, including standards and guidelines
(consistent with the provisions of section
1395dd of this title) for medically directed triage and transportation of trauma patients (including patients injured in rural areas) prior
to care in designated trauma centers;
(5) subject to subsection (b), contains national standards and requirements, including
those of the American Academy of Pediatrics
and the American College of Emergency Physicians, for medically directed triage and
transport of severely injured children to designated trauma centers with specified capabilities and expertise in the care of pediatric
trauma patients;
(6) utilizes a program with procedures for
the evaluation of designated trauma centers
(including trauma centers described in paragraph (5)) and trauma care systems;
(7) provides for the establishment and collection of data in accordance with data collection
requirements developed in consultation with
surgical, medical, and nursing specialty
groups, State and local emergency medical
services directors, and other trained professionals in trauma care, from each designated
trauma center in the State of a central data
reporting and analysis system—
(A) to identify the number of severely injured trauma patients and the number of
deaths from trauma within trauma care systems in the State;
(B) to identify the cause of the injury and
any factors contributing to the injury;
(C) to identify the nature and severity of
the injury;

Page 925

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) to monitor trauma patient care (including prehospital care) in each designated
trauma center within regional trauma care
systems in the State (including relevant
emergency-department discharges and rehabilitation information) for the purpose of
evaluating the diagnosis, treatment, and
treatment outcome of such trauma patients;
(E) to identify the total amount of uncompensated trauma care expenditures for each
fiscal year by each designated trauma center
in the State; and
(F) to identify patients transferred within
a regional trauma system, including reasons
for such transfer and the outcomes of such
patients;
(8) provides for the use of procedures by
paramedics and emergency medical technicians to assess the severity of the injuries incurred by trauma patients;
(9) provides for appropriate transportation
and transfer policies to ensure the delivery of
patients to designated trauma centers and
other facilities within and outside of the jurisdiction of such system, including policies to
ensure that only individuals appropriately
identified as trauma patients are transferred
to designated trauma centers, and to provide
periodic reviews of the transfers and the auditing of such transfers that are determined to be
appropriate;
(10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
(11) coordinates planning for trauma systems with State disaster emergency planning
and bioterrorism hospital preparedness planning; and
(12) with respect to the requirements established in this subsection, provides for coordination and cooperation between the State and
any other State with which the State shares
any standard metropolitan statistical area.
(b) Certain standards with respect to trauma
care centers and systems
(1) In general
The Secretary may not make payments
under section 300d–11(a) of this title for a fiscal year unless the State involved agrees that,
in carrying out paragraphs (3) through (5) of
subsection (a), the State will adopt standards
for the designation of trauma centers, and for
triage, transfer, and transportation policies,
and that the State will, in adopting such
standards—
(A) take into account national standards
that outline resources for optimal care of injured patients;
(B) consult with medical, surgical, and
nursing speciality groups, hospital associations, emergency medical services State and
local directors, concerned advocates, and
other interested parties;
(C) conduct hearings on the proposed
standards after providing adequate notice to
the public concerning such hearing; and
(D) beginning in fiscal year 2008, take into
account the model plan described in subsection (c).

§ 300d–13

(2) Quality of trauma care
The highest quality of trauma care shall be
the primary goal of State standards adopted
under this subsection.
(3) Approval by the Secretary
The Secretary may not make payments
under section 300d–11(a) of this title to a State
if the Secretary determines that—
(A) in the case of payments for fiscal year
2008 and subsequent fiscal years, the State
has not taken into account national standards, including those of the American College of Surgeons, the American College of
Emergency Physicians, and the American
Academy of Pediatrics, in adopting standards under this subsection; or
(B) in the case of payments for fiscal year
2008 and subsequent fiscal years, the State
has not, in adopting such standards, taken
into account the model plan developed under
subsection (c).
(c) Model trauma care plan
(1) In general
Not later than 1 year after May 3, 2007, the
Secretary shall update the model plan for the
designation of trauma centers and for triage,
transfer, and transportation policies that may
be adopted for guidance by the State. Such
plan shall—
(A) take into account national standards,
including those of the American College of
Surgeons, American College of Emergency
Physicians, and the American Academy of
Pediatrics;
(B) take into account existing State plans;
(C) be developed in consultation with medical, surgical, and nursing speciality groups,
hospital associations, emergency medical
services State directors and associations,
and other interested parties; and
(D) include standards for the designation
of rural health facilities and hospitals best
able to receive, stabilize, and transfer trauma patients to the nearest appropriate designated trauma center, and for triage, transfer, and transportation policies as they relate to rural areas.
(2) Applicability
Standards described in paragraph (1)(D) shall
be applicable to all rural areas in the State,
including both non-metropolitan areas and
frontier areas that have populations of less
than 6,000 per square mile.
(d) Rule of construction with respect to number
of designated trauma centers
With respect to compliance with subsection (a)
as a condition of the receipt of a grant under
section 300d–11(a) of this title, such subsection
may not be construed to specify the number of
trauma care centers designated pursuant to such
subsection.
(July 1, 1944, ch. 373, title XII, § 1213, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2920;
amended Pub. L. 103–183, title VI, § 601(f)(3), Dec.
14, 1993, 107 Stat. 2239; Pub. L. 105–392, title IV,
§ 401(b)(4), Nov. 13, 1998, 112 Stat. 3587; Pub. L.
110–23, § 7, May 3, 2007, 121 Stat. 93.)

§ 300d–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to requirements with respect to carrying out purpose of allotments.
1998—Subsec. (a)(8). Pub. L. 105–392 substituted ‘‘provides for’’ for ‘‘provides for for’’.
1993—Subsec. (a)(4). Pub. L. 103–183, § 601(f)(3)(A), substituted ‘‘section 1395dd of this title)’’ for ‘‘section
1395dd of this title’’.
Subsec. (a)(8), (9). Pub. L. 103–183, § 601(f)(3)(B), substituted ‘‘provides for’’ for ‘‘to provide’’ wherever appearing.
Subsec. (a)(10). Pub. L. 103–183, § 601(f)(3)(C), substituted ‘‘conducts’’ for ‘‘to conduct’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.

§ 300d–14. Requirement of submission to Secretary of trauma plan and certain information
(a) In general
For each fiscal year, the Secretary may not
make payments to a State under section
300d–11(a) of this title unless, subject to subsection (b), the State submits to the Secretary
the trauma care component of the State plan for
the provision of emergency medical services, including any changes to the trauma care component and any plans to address deficiencies in the
trauma care component.
(b) Interim plan or description of efforts
For each fiscal year, if a State has not completed the trauma care component of the State
plan described in subsection (a), the State may
provide, in lieu of such completed component,
an interim component or a description of efforts
made toward the completion of the component.
(c) Information received by State reporting and
analysis system
The Secretary may not make payments to a
State under section 300d–11(a) of this title unless
the State agrees that the State will, not less
than once each year, provide to the Secretary
the information received by the State pursuant
to section 300d–13(a)(7) of this title.
(d) Availability of emergency medical services in
rural areas
The Secretary may not make payments to a
State under section 300d–11(a) of this title unless—
(1) the State identifies any rural area in the
State for which—
(A) there is no system of access to emergency medical services through the telephone number 911;
(B) there is no basic life-support system;
or
(C) there is no advanced life-support system; and
(2) the State submits to the Secretary a list
of rural areas identified pursuant to paragraph
(1) or, if there are no such areas, a statement
that there are no such areas.
(July 1, 1944, ch. 373, title XII, § 1214, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2922;

Page 926

amended Pub. L. 110–23, § 8, May 3, 2007, 121 Stat.
96.)
AMENDMENTS
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to requirement of submission to Secretary of trauma plan and certain information for fiscal year 1991 and subsequent fiscal years.

§ 300d–15. Restrictions on use of payments
(a) In general
The Secretary may not, except as provided in
subsection (b), make payments under section
300d–11(a) of this title for a fiscal year unless the
State involved agrees that the payments will
not be expended—
(1) for any purpose other than developing,
implementing, and monitoring the modifications required by section 300d–11(b) of this
title to be made to the State plan for the provision of emergency medical services;
(2) to make cash payments to intended recipients of services provided pursuant to this
section;
(3) to purchase or improve real property
(other than minor remodeling of existing improvements to real property);
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition
for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private
entity.
(b) Waiver
The Secretary may waive a restriction under
subsection (a) only if the Secretary determines
that the activities outlined by the State plan
submitted under section 300d–14(a) of this title
by the State involved cannot otherwise be carried out.
(July 1, 1944, ch. 373, title XII, § 1215, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2923;
amended Pub. L. 110–23, § 9, May 3, 2007, 121 Stat.
97.)
AMENDMENTS
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to restrictions on use of
payments.

§ 300d–16. Repealed. Pub. L. 110–23, § 10, May 3,
2007, 121 Stat. 97
Section, act July 1, 1944, ch. 373, title XII, § 1216, as
added Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2923;
amended Pub. L. 103–183, title VI, § 601(c), Dec. 14, 1993,
107 Stat. 2238; Pub. L. 104–316, title I, § 122(d), Oct. 19,
1996, 110 Stat. 3837, provided for requirement of reports
by States.

§ 300d–17. Requirement of submission of application containing certain agreements and assurances
The Secretary may not make payments under
section 300d–11(a) of this title to a State for a
fiscal year unless—
(1) the State submits to the Secretary an application for the payments containing agreements in accordance with this part;
(2) the agreements are made through certification from the chief executive officer of the
State;

Page 927

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) with respect to such agreements, the application provides assurances of compliance
satisfactory to the Secretary;
(4) the application contains the plan provisions and the information required to be submitted to the Secretary pursuant to section
300d–14 of this title; and
(5) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this part.
(July 1, 1944, ch. 373, title XII, § 1217, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2924.)
§ 300d–18. Determination of amount of allotment
(a) Minimum allotment
Subject to the extent of amounts made available in appropriations Acts, the amount of an
allotment under section 300d–11(a) of this title
for a State for a fiscal year shall be the greater
of—
(1) the amount determined under subsection
(b)(1) of this section; and
(2) $250,000 in the case of each of the several
States, the District of Columbia, and the Commonwealth of Puerto Rico, and $50,000 in the
case of each of the Virgin Islands, Guam,
American Samoa, and the Commonwealth of
the Northern Mariana Islands.
(b) Determination under formula
(1) In general
The amount referred to in subsection (a)(1)
of this section for a State for a fiscal year is
the sum of—
(A) an amount determined under paragraph (2); and
(B) an amount determined under paragraph (3).
(2) Amount relating to population
The amount referred to in subparagraph (A)
of paragraph (1) for a State for a fiscal year is
the product of—
(A) an amount equal to 80 percent of the
amounts
appropriated
under
section
300d–32(a) of this title for the fiscal year and
available for allotment under section
300d–11(a) of this title; and
(B) a percentage equal to the quotient of—
(i) an amount equal to the population of
the State; divided by
(ii) an amount equal to the population of
all States.
(3) Amount relating to square mileage
The amount referred to in subparagraph (B)
of paragraph (1) for a State for a fiscal year is
the product of—
(A) an amount equal to 20 percent of the
amounts
appropriated
under
section
300d–32(a) of this title for the fiscal year and
available for allotment under section
300d–11(a) of this title; and
(B) a percentage equal to the quotient of—
(i) an amount equal to the lesser of
266,807 and the amount of the square mileage of the State; divided by
(ii) an amount equal to the sum of the
respective amounts determined for the
States under clause (i).

§ 300d–19

(c) Disposition of certain funds appropriated for
allotments
(1) In general
Amounts described in paragraph (2) shall, in
accordance with paragraph (3), be allotted by
the Secretary to States receiving payments
under section 300d–11(a) of this title for the fiscal year (other than any State referred to in
paragraph (2)(C)).
(2) Type of amounts
The amounts referred to in paragraph (1) are
any amounts made available pursuant to
300d–32(b)(3) of this title that are not paid
under section 300d–11(a) of this title to a State
as a result of—
(A) the failure of the State to submit an
application under section 300d–17 of this
title;
(B) the failure, in the determination of the
Secretary, of the State to prepare within a
reasonable period of time such application in
compliance with such section; or
(C) the State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made for the State.
(3) Amount
The amount of an allotment under paragraph (1) for a State for a fiscal year shall be
an amount equal to the product of—
(A) an amount equal to the amount described in paragraph (2) for the fiscal year
involved; and
(B) the percentage determined under subsection (b)(2) of this section for the State.
(July 1, 1944, ch. 373, title XII, § 1218, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2924.)
§ 300d–19. Failure to comply with agreements
(a) Repayment of payments
(1) Requirement
The Secretary may, in accordance with subsection (b) of this section, require a State to
repay any payments received by the State pursuant to section 300d–11(a) of this title that
the Secretary determines were not expended
by the State in accordance with the agreements required to be made by the State as a
condition of the receipt of payments under
such section.
(2) Offset of amounts
If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against any
amount due to be paid to the State under section 300d–11(a) of this title.
(b) Opportunity for hearing
Before requiring repayment of payments under
subsection (a)(1) of this section, the Secretary
shall provide to the State an opportunity for a
hearing.
(July 1, 1944, ch. 373, title XII, § 1219, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2925.)

§ 300d–20

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300d–20. Prohibition against certain false statements
(a) In general
(1) False statements or representations
A person may not knowingly and willfully
make or cause to be made any false statement
or representation of a material fact in connection with the furnishing of items or services
for which payments may be made by a State
from amounts paid to the State under section
300d–11(a) of this title.
(2) Concealing or failing to disclose information
A person with knowledge of the occurrence
of any event affecting the right of the person
to receive any payments from amounts paid to
the State under section 300d–11(a) of this title
may not conceal or fail to disclose any such
event with the intent of fraudulently securing
such amount.
(b) Criminal penalty for violation of prohibition
Any person who violates a prohibition established in subsection (a) of this section may for
each violation be fined in accordance with title
18, or imprisoned for not more than 5 years, or
both.
(July 1, 1944, ch. 373, title XII, § 1220, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2925.)
§ 300d–21. Technical assistance and provision by
Secretary of supplies and services in lieu of
grant funds
(a) Technical assistance
The Secretary shall, without charge to a State
receiving payments under section 300d–11(a) of
this title, provide to the State (or to any public
or nonprofit private entity designated by the
State) technical assistance with respect to the
planning, development, and operation of any
program carried out pursuant to section
300d–11(b) of this title. The Secretary may provide such technical assistance directly, through
contract, or through grants.
(b) Provision by Secretary of supplies and services in lieu of grant funds
(1) In general
Upon the request of a State receiving payments under section 300d–11(a) of this title, the
Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the
purpose of aiding the State in carrying out
section 300d–11(b) of this title and, for such
purpose, may detail to the State any officer or
employee of the Department of Health and
Human Services.
(2) Reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the
amount of payments to the State under section 300d–11(a) of this title by an amount equal
to the costs of detailing personnel and the fair
market value of any supplies, equipment, or
services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend
the amounts withheld.

Page 928

(July 1, 1944, ch. 373, title XII, § 1221, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2926.)
PRIOR PROVISIONS
A prior section 300d–21, act July 1, 1944, ch. 373, title
XII, § 1221, as added Oct. 21, 1976, Pub. L. 94–573, § 14(3),
90 Stat. 2718; amended Dec. 12, 1979, Pub. L. 96–142, title
I, § 107(a)–(c), 93 Stat. 1069, related to programs for burn,
trauma, and poison injuries, prior to repeal by Pub. L.
97–35, title IX, § 902(d)(1), (h), Aug. 13, 1981, 95 Stat. 560,
561, effective Oct. 1, 1981.

§ 300d–22. Report by Secretary
Not later than October 1, 2008, the Secretary
shall report to the appropriate committees of
Congress on the activities of the States carried
out pursuant to section 300d–11 of this title.
Such report shall include an assessment of the
extent to which Federal and State efforts to develop systems of trauma care and to designate
trauma centers have reduced the incidence of
mortality, and the incidence of permanent disability, resulting from trauma. Such report may
include any recommendations of the Secretary
for appropriate administrative and legislative
initiatives with respect to trauma care.
(July 1, 1944, ch. 373, title XII, § 1222, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2926;
amended Pub. L. 103–183, title VI, § 601(d), Dec.
14, 1993, 107 Stat. 2238; Pub. L. 110–23, § 11, May 3,
2007, 121 Stat. 97.)
AMENDMENTS
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section required Secretary to submit
report no later than Oct. 1, 1995.
1993—Pub. L. 103–183 substituted ‘‘1995’’ for ‘‘1992’’ and
inserted after first sentence ‘‘Such report shall include
an assessment of the extent to which Federal and State
efforts to develop systems of trauma care and to designate trauma centers have reduced the incidence of
mortality, and the incidence of permanent disability,
resulting from trauma.’’

PART C—GENERAL PROVISIONS REGARDING
PARTS A AND B
§ 300d–31. Definitions
For purposes of this part and parts A and B of
this subchapter:
(1) Designated trauma center
The term ‘‘designated trauma center’’ means
a trauma center designated in accordance with
the modifications to the State plan described
in section 300d–13 of this title.
(2) State plan regarding emergency medical
services
The term ‘‘State plan’’, with respect to the
provision of emergency medical services,
means a plan for a comprehensive, organized
system to provide for the access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and rehabilitation
of patients of all ages with respect to emergency medical services.
(3) State
The term ‘‘State’’ means each of the several
States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands,
Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

Page 929

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) Trauma
The term ‘‘trauma’’ means an injury resulting from exposure to a mechanical force.
(5) Trauma care component of State plan
The term ‘‘trauma care component’’, with
respect to components of the State plan for
the provision of emergency medical services,
means a plan for a comprehensive health care
system, within rural and urban areas of the
State, for the prompt recognition, prehospital
care, emergency medical care, acute surgical
and medical care, rehabilitation, and outcome
evaluation of seriously injured patients.
(July 1, 1944, ch. 373, title XII, § 1231, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2926;
amended Pub. L. 102–321, title VI, § 602(2), July
10, 1992, 106 Stat. 436; Pub. L. 103–183, title VI,
§ 601(f)(4), Dec. 14, 1993, 107 Stat. 2239.)
AMENDMENTS
1993—Par. (3). Pub. L. 103–183 substituted ‘‘Puerto
Rico,’’ for ‘‘Puerto Rico;’’.
1992—Pub. L. 102–321 substituted ‘‘this part and parts
A and B of this subchapter’’ for ‘‘this subchapter’’ in introductory provisions.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective July 10, 1992,
with provision for programs providing financial assistance, see section 801(b), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 300d–32. Funding
(a) Authorization of appropriations
For the purpose of carrying out parts A and B,
subject to subsections (b) and (c), there are authorized to be appropriated $24,000,000 for each of
fiscal years 2010 through 2014.
(b) Reservation of funds
If the amount appropriated under subsection
(a) for a fiscal year is equal to or less than
$1,000,000, such appropriation is available only
for the purpose of carrying out part A. If the
amount so appropriated is greater than
$1,000,000, 50 percent of such appropriation shall
be made available for the purpose of carrying
out part A and 50 percent shall be made available for the purpose of carrying out part B.
(c) Allocation of part A funds
Of the amounts appropriated under subsection
(a) for a fiscal year to carry out part A—
(1) 10 percent of such amounts for such year
shall be allocated for administrative purposes;
and
(2) 10 percent of such amounts for such year
shall be allocated for the purpose of carrying
out section 300d–3 of this title.
(d) Authority
For the purpose of carrying out parts A
through C, beginning on March 23, 2010, the Secretary shall transfer authority in administering
grants and related authorities under such parts
from the Administrator of the Health Resources
and Services Administration to the Assistant
Secretary for Preparedness and Response.
(July 1, 1944, ch. 373, title XII, § 1232, as added
Pub. L. 101–590, § 3, Nov. 16, 1990, 104 Stat. 2927;

§ 300d–41

amended Pub. L. 102–321, title VI, § 602(3), July
10, 1992, 106 Stat. 436; Pub. L. 103–183, title VI,
§ 602, Dec. 14, 1993, 107 Stat. 2239; Pub. L. 105–392,
title IV, §§ 401(a)(2), 413, Nov. 13, 1998, 112 Stat.
3587, 3590; Pub. L. 110–23, § 12, May 3, 2007, 121
Stat. 97; Pub. L. 111–148, title III, § 3504(a)(3),
Mar. 23, 2010, 124 Stat. 520.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 3504(a)(3)(A), substituted ‘‘$24,000,000 for each of fiscal years 2010 through
2014’’ for ‘‘$12,000,000 for fiscal year 2008, $10,000,000 for
fiscal year 2009, and $8,000,000 for each of the fiscal
years 2010 through 2012’’.
Subsec. (d). Pub. L. 111–148, § 3504(a)(3)(B), added subsec. (d).
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to funding for fiscal
years 1994 through 2002.
1998—Subsec. (a). Pub. L. 105–392, § 413, substituted
‘‘through 2002’’ for ‘‘and 1996’’.
Pub. L. 105–392, § 401(a)(2), amended directory language of Pub. L. 103–183. See 1993 Amendment note
below.
1993—Subsec. (a). Pub. L. 103–183, as amended by Pub.
L. 105–392, § 401(a)(2), substituted ‘‘For the purpose of
carrying out parts A and B of this subchapter, there are
authorized to be appropriated $6,000,000 for fiscal year
1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996’’ for ‘‘For the purpose of carrying out parts A and B of this subchapter, there are
authorized to be appropriated $60,000,000 for fiscal year
1991 and such sums as may be necessary for each of the
fiscal years 1992 and 1993’’.
1992—Subsec. (a). Pub. L. 102–321 substituted ‘‘parts A
and B of this subchapter’’ for ‘‘this subchapter’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by section 401(a)(2) of Pub. L. 105–392
deemed to have taken effect immediately after enactment of Pub. L. 103–183, see section 401(e) of Pub. L.
105–392, set out as a note under section 242m of this
title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective July 10, 1992,
with provision for programs providing financial assistance, see section 801(b), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.

§ 300d–33. Repealed. Pub. L. 103–183, title VI,
§ 601(e), Dec. 14, 1993, 107 Stat. 2239
Section, act July 1, 1944, ch. 373, title XII, § 1233, as
added Nov. 16, 1990, Pub. L. 101–590, § 3, 104 Stat. 2927, related to waiver of requirement regarding purpose of
grants.

PART D—TRAUMA CENTERS OPERATING IN
AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
§ 300d–41. Grants for certain trauma centers
(a) In general
The Secretary shall establish 3 programs to
award grants to qualified public, nonprofit Indian Health Service, Indian tribal, and urban Indian trauma centers—
(1) to assist in defraying substantial uncompensated care costs;
(2) to further the core missions of such trauma centers, including by addressing costs associated with patient stabilization and transfer, trauma education and outreach, coordination with local and regional trauma systems,
essential personnel and other fixed costs, and

§ 300d–42

TITLE 42—THE PUBLIC HEALTH AND WELFARE

expenses associated with employee and nonemployee physician services; and
(3) to provide emergency relief to ensure the
continued and future availability of trauma
services.
(b) Minimum qualifications of trauma centers
(1) Participation in trauma care system operating under certain professional guidelines
Except as provided in paragraph (2), the Secretary may not award a grant to a trauma
center under subsection (a) unless the trauma
center is a participant in a trauma system
that substantially complies with section
300d–13 of this title.
(2) Exemption
Paragraph (1) shall not apply to trauma centers that are located in States with no existing trauma care system.
(3) Qualification for substantial uncompensated care costs
The Secretary shall award substantial uncompensated care grants under subsection
(a)(1) only to trauma centers meeting at least
1 of the criteria in 1 of the following 3 categories:
(A) Category A
The criteria for category A are as follows:
(i) At least 40 percent of the visits in the
emergency department of the hospital in
which the trauma center is located were
charity or self-pay patients.
(ii) At least 50 percent of the visits in
such emergency department were Medicaid
(under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.)) and charity and
self-pay patients combined.
(B) Category B
The criteria for category B are as follows:
(i) At least 35 percent of the visits in the
emergency department were charity or
self-pay patients.
(ii) At least 50 percent of the visits in the
emergency department were Medicaid and
charity and self-pay patients combined.
(C) Category C
The criteria for category C are as follows:
(i) At least 20 percent of the visits in the
emergency department were charity or
self-pay patients.
(ii) At least 30 percent of the visits in the
emergency department were Medicaid and
charity and self-pay patients combined.
(4) Trauma centers in 1115 waiver States
Notwithstanding paragraph (3), the Secretary may award a substantial uncompensated care grant to a trauma center under subsection (a)(1) if the trauma center qualifies for
funds under a Low Income Pool or Safety Net
Care Pool established through a waiver approved under section 1115 of the Social Security Act (42 U.S.C. 1315).
(5) Designation
The Secretary may not award a grant to a
trauma center unless such trauma center is
verified by the American College of Surgeons

Page 930

or designated by an equivalent State or local
agency.
(c) Additional requirements
The Secretary may not award a grant to a
trauma center under subsection (a)(1) unless
such trauma center—
(1) submits to the Secretary a plan satisfactory to the Secretary that demonstrates a
continued commitment to serving trauma patients regardless of their ability to pay; and
(2) has policies in place to assist patients
who cannot pay for part or all of the care they
receive, including a sliding fee scale, and to
ensure fair billing and collection practices.
(July 1, 1944, ch. 373, title XII, § 1241, as added
Pub. L. 102–321, title VI, § 601, July 10, 1992, 106
Stat. 433; amended Pub. L. 111–148, title III,
§ 3505(a)(1), Mar. 23, 2010, 124 Stat. 522.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(b)(3)(A)(ii), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.
Title XIX of the Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
AMENDMENTS
2010—Pub. L. 111–148 added subsecs. (a) to (c) and
struck out former subsecs. (a) and (b) which related to
grants for trauma centers in geographic areas with a
significant incidence of violence arising from illicit
trafficking in drugs and set forth minimum qualifications of such centers.
EFFECTIVE DATE
Part effective July 10, 1992, with programs making
awards providing financial assistance in fiscal year 1993
and subsequent years effective for awards made on or
after Oct. 1, 1992, see section 801(b), (d)(1) of Pub. L.
102–321, set out as an Effective Date of 1992 Amendment
note under section 236 of this title.

§ 300d–42. Preferences in making grants
(a) Substantial uncompensated care awards
(1) In general
The Secretary shall establish an award basis
for each eligible trauma center for grants
under section 300d–41(a)(1) of this title according to the percentage described in paragraph
(2), subject to the requirements of section
300d–41(b)(3) of this title.
(2) Percentages
The applicable percentages are as follows:
(A) With respect to a category A trauma
center, 100 percent of the uncompensated
care costs.
(B) With respect to a category B trauma
center, not more than 75 percent of the uncompensated care costs.
(C) With respect to a category C trauma
center, not more than 50 percent of the uncompensated care costs.
(b) Core mission awards
(1) 1 In general
In
awarding
grants
under
section
300d–41(a)(2) of this title, the Secretary shall—
1 So

in original. No par. (2) has been enacted.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) reserve 25 percent of the amount allocated for core mission awards for Level III
and Level IV trauma centers; and
(B) reserve 25 percent of the amount allocated for core mission awards for large
urban Level I and II trauma centers—
(i) that have at least 1 graduate medical
education fellowship in trauma or trauma
related specialties for which demand is exceeding supply;
(ii) for which—
(I) annual uncompensated care costs
exceed $10,000,000; or
(II) at least 20 percent of emergency
department visits are charity or self-pay
or Medicaid patients; and
(iii) that are not eligible for substantial
uncompensated care awards under section
300d–41(a)(1) of this title.
(c) Emergency awards
In awarding grants under section 300d–41(a)(3)
of this title, the Secretary shall—
(1) give preference to any application submitted by a trauma center that provides trauma care in a geographic area in which the
availability of trauma care has significantly
decreased or will significantly decrease if the
center is forced to close or downgrade service
or growth in demand for trauma services exceeds capacity; and
(2) reallocate any emergency awards funds
not obligated due to insufficient, or a lack of
qualified, applications to the significant uncompensated care award program.
(July 1, 1944, ch. 373, title XII, § 1242, as added
Pub. L. 102–321, title VI, § 601, July 10, 1992, 106
Stat. 434; amended Pub. L. 111–148, title III,
§ 3505(a)(2), Mar. 23, 2010, 124 Stat. 523.)
AMENDMENTS
2010—Pub. L. 111–148 added subsecs. (a) to (c) and
struck out former subsecs. (a) and (b) which related to
preferences in making grants and preferences for certain applications.

§ 300d–43. Certain agreements
(a) Maintenance of financial support
The Secretary may require a trauma center
receiving a grant under section 300d–41(a) of this
title to maintain access to trauma services at
comparable levels to the prior year during the
grant period.
(b) Trauma care registry
The Secretary may require the trauma center
receiving a grant under section 300d–41(a) of this
title to provide data to a national and centralized registry of trauma cases, in accordance
with guidelines developed by the American College of Surgeons, and as the Secretary may
otherwise require.
(July 1, 1944, ch. 373, title XII, § 1243, as added
Pub. L. 102–321, title VI, § 601, July 10, 1992, 106
Stat. 434; amended Pub. L. 111–148, title III,
§ 3505(a)(3), Mar. 23, 2010, 124 Stat. 524.)
AMENDMENTS
2010—Pub. L. 111–148 added subsecs. (a) and (b) and
struck out former subsecs. (a) to (c) which related to

§ 300d–44

commitment regarding continued participation in trauma care system, maintenance of financial support, and
trauma care registry.

§ 300d–44. General provisions
(a) Application
The Secretary may not award a grant to a
trauma center under section 300d–41(a) of this
title unless such center submits an application
for the grant to the Secretary and the application is in such form, is made in such manner,
and contains such agreements, assurances, and
information as the Secretary determines to be
necessary to carry out this part.
(b) Limitation on duration of support
The period during which a trauma center receives payments under a grant under section
300d–41(a)(3) of this title shall be for 3 fiscal
years, except that the Secretary may waive such
requirement for a center and authorize such center to receive such payments for 1 additional fiscal year.
(c) Limitation on amount of grant
Notwithstanding section 300d–42(a) of this
title, a grant under section 300d–41 of this title
may not be made in an amount exceeding
$2,000,000 for each fiscal year.
(d) Eligibility
Except
as
provided
in
section
300d–42(b)(1)(B)(iii) of this title, acquisition of,
or eligibility for, a grant under section
300d–41(a) of this title shall not preclude a trauma center from being eligible for other grants
described in such section.
(e) Funding distribution
Of the total amount appropriated for a fiscal
year under section 300d–45 of this title, 70 percent shall be used for substantial uncompensated care awards under section 300d–41(a)(1) of
this title, 20 percent shall be used for core mission awards under section 300d–41(a)(2) of this
title, and 10 percent shall be used for emergency
awards under section 300d–41(a)(3) of this title.
(f) Minimum allowance
Notwithstanding subsection (e), if the amount
appropriated for a fiscal year under section
300d–45 of this title is less than $25,000,000, all
available funding for such fiscal year shall be
used for substantial uncompensated care awards
under section 300d–41(a)(1) of this title.
(g) Substantial uncompensated care award distribution and proportional share
Notwithstanding section 300d–42(a) of this
title, of the amount appropriated for substantial
uncompensated care grants for a fiscal year, the
Secretary shall—
(1) make available—
(A) 50 percent of such funds for category A
trauma center grantees;
(B) 35 percent of such funds for category B
trauma center grantees; and
(C) 15 percent of such funds for category C
trauma center grantees; and
(2) provide available funds within each category in a manner proportional to the award
basis specified in section 300d–42(a)(2) of this
title to each eligible trauma center.

§ 300d–45

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(h) Report
Beginning 2 years after March 23, 2010, and
every 2 years thereafter, the Secretary shall biennially report to Congress regarding the status
of the grants made under section 300d–41 of this
title and on the overall financial stability of
trauma centers.
(July 1, 1944, ch. 373, title XII, § 1244, as added
Pub. L. 102–321, title VI, § 601, July 10, 1992, 106
Stat. 435; amended Pub. L. 111–148, title III,
§ 3505(a)(4), Mar. 23, 2010, 124 Stat. 524.)
AMENDMENTS
2010—Pub. L. 111–148 added subsecs. (a) to (h) and
struck out former subsecs. (a) to (c) which related to
application for grant, limitation on duration of support, and limitation on amount of grant.

§ 300d–45. Authorization of appropriations
For the purpose of carrying out this part,
there are authorized to be appropriated
$100,000,000 for fiscal year 2009, and such sums as
may be necessary for each of fiscal years 2010
through 2015. Such authorization of appropriations is in addition to any other authorization of
appropriations or amounts that are available for
such purpose.
(July 1, 1944, ch. 373, title XII, § 1245, as added
Pub. L. 102–321, title VI, § 601, July 10, 1992, 106
Stat. 435; amended Pub. L. 111–148, title III,
§ 3505(a)(5), Mar. 23, 2010, 124 Stat. 525.)
AMENDMENTS
2010—Pub. L. 111–148 amended section generally. Prior
to amendment, text read as follows: ‘‘For the purpose
of carrying out this part, there are authorized to be appropriated $100,000,000 for fiscal year 1993, and such
sums as may be necessary for fiscal year 1994. Such authorization of appropriations is in addition to any
other authorization of appropriations or amounts that
are available for such purpose.’’

§ 300d–46. Definition
In this part, the term ‘‘uncompensated care
costs’’ means unreimbursed costs from serving
self-pay, charity, or Medicaid patients, without
regard to payment under section 1396r–4 of this
title, all of which are attributable to emergency
care and trauma care, including costs related to
subsequent inpatient admissions to the hospital.
(July 1, 1944, ch. 373, title XII, § 1246, as added
Pub. L. 111–148, title III, § 3505(a)(6), Mar. 23, 2010,
124 Stat. 525.)
PART E—MISCELLANEOUS PROGRAMS
§ 300d–51. Residency training programs in emergency medicine
(a) In general
The Secretary may make grants to public and
nonprofit private entities for the purpose of
planning and developing approved residency
training programs in emergency medicine.
(b) Identification and referral of domestic violence
The Secretary may make a grant under subsection (a) only if the applicant involved agrees
that the training programs under subsection (a)
will provide education and training in identifying and referring cases of domestic violence.

Page 932

(c) Authorization of appropriations
For the purpose of carrying out this section,
there is authorized to be appropriated $400,000
for each of the fiscal years 2008 though 2012.
(July 1, 1944, ch. 373, title XII, § 1251, as added
Pub. L. 102–408, title III, § 304, Oct. 13, 1992, 106
Stat. 2084; amended Pub. L. 110–23, § 13, May 3,
2007, 121 Stat. 98.)
AMENDMENTS
2007—Pub. L. 110–23 amended section generally. Prior
to amendment, section related to residency training
programs in emergency medicine and authorized appropriations for fiscal years 1993 through 1995.

§ 300d–52. State grants for projects regarding
traumatic brain injury
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to States and
American Indian consortia for the purpose of
carrying out projects to improve access to rehabilitation and other services regarding traumatic brain injury.
(b) State advisory board
(1) In general
The Secretary may make a grant under subsection (a) of this section only if the State or
American Indian consortium involved agrees
to establish an advisory board within the appropriate health department of the State or
American Indian consortium or within another department as designated by the chief
executive officer of the State or American Indian consortium.
(2) Functions
An advisory board established under paragraph (1) shall advise and make recommendations to the State or American Indian consortium on ways to improve services coordination
regarding traumatic brain injury. Such advisory boards shall encourage citizen participation through the establishment of public hearings and other types of community outreach
programs. In developing recommendations
under this paragraph, such boards shall consult with Federal, State, and local governmental agencies and with citizens groups and
other private entities.
(3) Composition
An advisory board established under paragraph (1) shall be composed of—
(A) representatives of—
(i) the corresponding State or American
Indian consortium agencies involved;
(ii) public and nonprofit private health
related organizations;
(iii) other disability advisory or planning
groups within the State or American Indian consortium;
(iv) members of an organization or foundation representing individuals with traumatic brain injury in that State or American Indian consortium; and
(v) injury control programs at the State
or local level if such programs exist; and
(B) a substantial number of individuals
with traumatic brain injury, or the family
members of such individuals.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Matching funds
(1) In general
With respect to the costs to be incurred by
a State or American Indian consortium in carrying out the purpose described in subsection
(a) of this section, the Secretary may make a
grant under such subsection only if the State
or American Indian consortium agrees to
make available non-Federal contributions toward such costs in an amount that is not less
than $1 for each $2 of Federal funds provided
under the grant.
(2) Determination of amount contributed
Non-Federal contributions under paragraph
(1) may be in cash or in kind, fairly evaluated,
including plant, equipment, or services.
Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the
amount of such contributions.
(d) Application for grant
The Secretary may make a grant under subsection (a) of this section only if an application
for the grant is submitted to the Secretary and
the application is in such form, is made in such
manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(e) Continuation of previously awarded demonstration projects
A State or American Indian consortium that
received a grant under this section prior to
April 28, 2008, may complete the activities funded by the grant.
(f) Use of State and American Indian consortium
grants
(1) Community services and supports
A State or American Indian consortium
shall (directly or through awards of contracts
to nonprofit private entities) use amounts received under a grant under this section for the
following:
(A) To develop, change, or enhance community-based service delivery systems that
include timely access to comprehensive appropriate services and supports. Such service
and supports—
(i) shall promote full participation by individuals with brain injury and their families in decision making regarding the services and supports; and
(ii) shall be designed for children, youth,
and adults with traumatic brain injury.
(B) To focus on outreach to underserved
and inappropriately served individuals, such
as individuals in institutional settings, individuals with low socioeconomic resources,
individuals in rural communities, and individuals in culturally and linguistically diverse communities.
(C) To award contracts to nonprofit entities for consumer or family service access
training, consumer support, peer mentoring,
and parent to parent programs.
(D) To develop individual and family service coordination or case management systems.

§ 300d–52

(E) To support other needs identified by
the advisory board under subsection (b) of
this section for the State or American Indian consortium involved.
(2) Best practices
(A) In general
State or American Indian consortium services and supports provided under a grant
under this section shall reflect the best practices in the field of traumatic brain injury,
shall be in compliance with title II of the
Americans with Disabilities Act of 1990 [42
U.S.C. 12131 et seq.], and shall be supported
by quality assurance measures as well as
state-of-the-art health care and integrated
community supports, regardless of the severity of injury.
(B) Demonstration by State agency
The State or American Indian consortium
agency
responsible
for
administering
amounts received under a grant under this
section shall demonstrate that it has obtained knowledge and expertise of traumatic
brain injury and the unique needs associated
with traumatic brain injury.
(3) State capacity building
A State or American Indian consortium may
use amounts received under a grant under this
section to—
(A) educate consumers and families;
(B) train professionals in public and private sector financing (such as third party
payers, State agencies, community-based
providers, schools, and educators);
(C) develop or improve case management
or service coordination systems;
(D) develop best practices in areas such as
family or consumer support, return to work,
housing or supportive living personal assistance services, assistive technology and devices, behavioral health services, substance
abuse services, and traumatic brain injury
treatment and rehabilitation;
(E) tailor existing State or American Indian consortium systems to provide accommodations to the needs of individuals with
brain injury (including systems administered by the State or American Indian consortium departments responsible for health,
mental health, labor/employment, education, intellectual disabilities or developmental disorders, transportation, and correctional systems);
(F) improve data sets coordinated across
systems and other needs identified by a
State or American Indian consortium plan
supported by its advisory council; and
(G) develop capacity within targeted communities.
(g) Coordination of activities
The Secretary shall ensure that activities
under this section are coordinated as appropriate with other Federal agencies that carry
out activities regarding traumatic brain injury.
(h) Report
Not less than biennially, the Secretary shall
submit to the Committee on Energy and Com-

§ 300d–52

TITLE 42—THE PUBLIC HEALTH AND WELFARE

merce of the House of Representatives, and to
the Committee on Health, Education, Labor,
and Pensions of the Senate, a report describing
the findings and results of the programs established under this section, and section 300d–53 of
this title including measures of outcomes and
consumer and surrogate satisfaction.
(i) Definitions
For purposes of this section:
(1) The terms ‘‘American Indian consortium’’ and ‘‘State’’ have the meanings given to
those terms in section 300d–53 of this title.
(2) The term ‘‘traumatic brain injury’’
means an acquired injury to the brain. Such
term does not include brain dysfunction
caused by congenital or degenerative disorders, nor birth trauma, but may include
brain injuries caused by anoxia due to trauma.
The Secretary may revise the definition of
such term as the Secretary determines necessary, after consultation with States and
other appropriate public or nonprofit private
entities.
(j) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005, and such sums as may
be necessary for each of the fiscal years 2009
through 2012.
(July 1, 1944, ch. 373, title XII, § 1252, as added
Pub. L. 104–166, § 3, July 29, 1996, 110 Stat. 1446;
amended Pub. L. 106–310, div. A, title XIII, § 1304,
Oct. 17, 2000, 114 Stat. 1139; Pub. L. 110–23, § 14,
May 3, 2007, 121 Stat. 99; Pub. L. 110–206, § 6(a),
Apr. 28, 2008, 122 Stat. 716; Pub. L. 111–256,
§ 2(f)(6), Oct. 5, 2010, 124 Stat. 2644.)
REFERENCES IN TEXT
The Americans with Disabilities Act of 1990, referred
to in subsec. (f)(2)(A), is Pub. L. 101–336, July 26, 1990,
104 Stat. 327, as amended. Title II of the Act is classified generally to subchapter II (§ 12131 et seq.) of chapter 126 of this title. For complete classification of this
Act to the Code, see Short Title note set out under section 12101 of this title and Tables.
AMENDMENTS
2010—Subsec. (f)(3)(E). Pub. L. 111–256 substituted ‘‘intellectual disabilities or developmental disorders,’’ for
‘‘mental retardation/developmental disorders,’’.
2008—Subsec. (a). Pub. L. 110–206, § 6(a)(1), substituted
‘‘may make grants to States and American Indian consortia’’ for ‘‘may make grants to States’’ and ‘‘rehabilitation and other services’’ for ‘‘health and other services’’.
Subsec. (b)(1). Pub. L. 110–206, § 6(a)(2)(A), substituted
‘‘State or American Indian consortium’’ for ‘‘State’’
wherever appearing.
Subsec. (b)(2). Pub. L. 110–206, § 6(a)(2)(B), substituted
‘‘recommendations to the State or American Indian
consortium’’ for ‘‘recommendations to the State’’.
Subsec. (b)(3)(A)(i), (iii), (iv). Pub. L. 110–206,
§ 6(a)(2)(A), substituted ‘‘State or American Indian consortium’’ for ‘‘State’’.
Subsec. (c)(1). Pub. L. 110–206, § 6(a)(3), substituted
‘‘State or American Indian consortium’’ for ‘‘State’’ in
two places.
Subsec. (e). Pub. L. 110–206, § 6(a)(4), added text of subsec. (e) and struck out former text of subsec. (e) which
read as follows: ‘‘A State that received a grant under
this section prior to October 17, 2000, may compete for
new project grants under this section after October 17,
2000.’’

Page 934

Subsec. (f). Pub. L. 110–206, § 6(a)(5)(A), (B), inserted
‘‘and American Indian consortium’’ after ‘‘State’’ in
heading and substituted in text ‘‘State or American Indian consortium’’ for ‘‘State’’ wherever appearing, except in par. (3)(B).
Subsec. (f)(1)(A)(ii). Pub. L. 110–206, § 6(a)(5)(C), substituted ‘‘children, youth, and adults’’ for ‘‘children
and other individuals’’.
Subsec. (h). Pub. L. 110–206, § 6(a)(6), substituted ‘‘Not
less than biennially, the Secretary’’ for ‘‘Not later than
2 years after July 29, 1996, the Secretary’’ and ‘‘Energy
and Commerce of the House of Representatives, and to
the Committee on Health, Education, Labor, and Pensions’’ for ‘‘Commerce of the House of Representatives,
and to the Committee on Labor and Human Resources’’
and inserted ‘‘and section 300d–53 of this title’’ after
‘‘programs established under this section,’’.
Subsec. (i). Pub. L. 110–206, § 6(a)(7), amended subsec.
(i) generally. Prior to amendment, text read as follows:
‘‘For purposes of this section, the term ‘traumatic
brain injury’ means an acquired injury to the brain.
Such term does not include brain dysfunction caused
by congenital or degenerative disorders, nor birth trauma, but may include brain injuries caused by anoxia
due to trauma. The Secretary may revise the definition
of such term as the Secretary determines necessary,
after consultation with States and other appropriate
public or nonprofit private entities.’’
Subsec. (j). Pub. L. 110–206, § 6(a)(8), inserted ‘‘, and
such sums as may be necessary for each of the fiscal
years 2009 through 2012’’ before period at end.
2007—Pub. L. 110–23, which directed amendment of
section by striking ‘‘demonstration’’ in section catchline, could not be executed because the word ‘‘demonstration’’ did not appear after amendment by Pub. L.
106–310, § 1304(1). See 2000 Amendment note below.
2000—Pub. L. 106–310, § 1304(1), struck out ‘‘demonstration’’ before ‘‘projects’’ in section catchline.
Subsec. (a). Pub. L. 106–310, § 1304(2), struck out ‘‘demonstration’’ before ‘‘projects’’.
Subsec. (b)(3)(A)(iv). Pub. L. 106–310, § 1304(3)(A), substituted ‘‘representing individuals with traumatic
brain injury’’ for ‘‘representing traumatic brain injury
survivors’’.
Subsec. (b)(3)(B). Pub. L. 106–310, § 1304(3)(B), substituted ‘‘with traumatic brain injury’’ for ‘‘who are
survivors of traumatic brain injury’’.
Subsec. (c)(1). Pub. L. 106–310, § 1304(4)(A), struck out
‘‘, in cash,’’ before ‘‘non-Federal contributions’’.
Subsec. (c)(2). Pub. L. 106–310, § 1304(4)(B), reenacted
heading without change and amended text generally.
Prior to amendment, text read as follows: ‘‘In determining the amount of non-Federal contributions in
cash that a State has provided pursuant to paragraph
(1), the Secretary may not include any amounts provided to the State by the Federal Government.’’
Subsecs. (e), (f). Pub. L. 106–310, § 1304(6), added subsecs. (e) and (f). Former subsecs. (e) and (f) redesignated
(g) and (h), respectively.
Subsec. (g). Pub. L. 106–310, § 1304(5), (7), redesignated
subsec. (e) as (g) and substituted ‘‘Federal agencies’’ for
‘‘agencies of the Public Health Service’’. Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 106–310, § 1304(5), redesignated subsec. (f) as (h). Former subsec. (h) redesignated (j).
Subsec. (i). Pub. L. 106–310, § 1304(5), (8), redesignated
subsec. (g) as (i), substituted ‘‘anoxia due to trauma’’
for ‘‘anoxia due to near drowning’’ in second sentence,
and inserted before period at end ‘‘, after consultation
with States and other appropriate public or nonprofit
private entities’’.
Subsec. (j). Pub. L. 106–310, § 1304(9), reenacted heading without change and amended text generally. Prior
to amendment, text read as follows: ‘‘For the purpose
of carrying out this section, there is authorized to be
appropriated $5,000,000 for each of the fiscal years 1997
through 1999.’’
Pub. L. 106–310, § 1304(5), redesignated subsec. (h) as
(j).

Page 935

TITLE 42—THE PUBLIC HEALTH AND WELFARE
DEFINITIONS

For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 300d–53. State grants for protection and advocacy services
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the
‘‘Administrator’’), shall make grants to protection and advocacy systems for the purpose of enabling such systems to provide services to individuals with traumatic brain injury.
(b) Services provided
Services provided under this section may include the provision of—
(1) information, referrals, and advice;
(2) individual and family advocacy;
(3) legal representation; and
(4) specific assistance in self-advocacy.
(c) Application
To be eligible to receive a grant under this
section, a protection and advocacy system shall
submit an application to the Administrator at
such time, in such form and manner, and accompanied by such information and assurances as
the Administrator may require.
(d) Appropriations less than $2,700,000
(1) In general
With respect to any fiscal year in which the
amount appropriated under subsection (l) of
this section to carry out this section is less
than $2,700,000, the Administrator shall make
grants from such amount to individual protection and advocacy systems within States to
enable such systems to plan for, develop outreach strategies for, and carry out services authorized under this section for individuals
with traumatic brain injury.
(2) Amount
The amount of each grant provided under
paragraph (1) shall be determined as set forth
in paragraphs (2) and (3) of subsection (e) of
this section.
(e) Appropriations of $2,700,000 or more
(1) Population basis
Except as provided in paragraph (2), with respect to each fiscal year in which the amount
appropriated under subsection (l) of this section to carry out this section is $2,700,000 or
more, the Administrator shall make a grant to
a protection and advocacy system within each
State.
(2) Amount
The amount of a grant provided to a system
under paragraph (1) shall be equal to an
amount bearing the same ratio to the total
amount appropriated for the fiscal year involved under subsection (l) of this section as
the population of the State in which the
grantee is located bears to the population of
all States.

§ 300d–53

(3) Minimums
Subject to the availability of appropriations,
the amount of a grant 1 a protection and advocacy system under paragraph (1) for a fiscal
year shall—
(A) in the case of a protection and advocacy system located in American Samoa,
Guam, the United States Virgin Islands, or
the Commonwealth of the Northern Mariana
Islands, and the protection and advocacy
system serving the American Indian consortium, not be less than $20,000; and
(B) in the case of a protection and advocacy system in a State not described in subparagraph (A), not be less than $50,000.
(4) Inflation adjustment
For each fiscal year in which the total
amount appropriated under subsection (l) of
this section to carry out this section is
$5,000,000 or more, and such appropriated
amount exceeds the total amount appropriated to carry out this section in the preceding fiscal year, the Administrator shall increase each of the minimum grants amount
described in subparagraphs (A) and (B) of paragraph (3) by a percentage equal to the percentage increase in the total amount appropriated
under subsection (l) of this section to carry
out this section between the preceding fiscal
year and the fiscal year involved.
(f) Carryover
Any amount paid to a protection and advocacy
system that serves a State or the American Indian consortium for a fiscal year under this section that remains unobligated at the end of such
fiscal year shall remain available to such system for obligation during the next fiscal year
for the purposes for which such amount was
originally provided.
(g) Direct payment
Notwithstanding any other provision of law,
each fiscal year not later than October 1, the
Administrator shall pay directly to any protection and advocacy system that complies with
the provisions of this section, the total amount
of the grant for such system, unless the system
provides otherwise for such payment.
(h) Annual report
Each protection and advocacy system that receives a payment under this section shall submit an annual report to the Administrator concerning the services provided to individuals with
traumatic brain injury by such system.
(i) Data collection
The Administrator of the Health Resources
and Services Administration and the Commissioner of the Administration on Developmental
Disabilities shall enter into an agreement to
coordinate the collection of data by the Administrator and the Commissioner regarding protection and advocacy services.
(j) Training and technical assistance
(1) Grants
For any fiscal year for which the amount appropriated to carry out this section is
1 So

in original. Probably should be followed by ‘‘to’’.

§ 300d–61

TITLE 42—THE PUBLIC HEALTH AND WELFARE

$6,000,000 or greater, the Administrator shall
use 2 percent of such amount to make a grant
to an eligible national association for providing for training and technical assistance to
protection and advocacy systems.
(2) Definition
In this subsection, the term ‘‘eligible national association’’ means a national association with demonstrated experience in providing training and technical assistance to protection and advocacy systems.
(k) System authority
In providing services under this section, a protection and advocacy system shall have the
same authorities, including access to records, as
such system would have for purposes of providing services under subtitle C of the Developmental Disabilities Assistance and Bill of Rights
Act of 2000 [42 U.S.C. 15041 et seq.].
(l) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $5,000,000 for fiscal year
2001, and such sums as may be necessary for
each 2 the fiscal years 2009 through 2012.
(m) Definitions
In this section:
(1) American Indian consortium
The term ‘‘American Indian consortium’’
means a consortium established under part C
of the Developmental Disabilities Assistance 3
Bill of Rights Act (42 U.S.C. 6042 et seq.).4
(2) Protection and advocacy system
The term ‘‘protection and advocacy system’’
means a protection and advocacy system established under part C of the Developmental
Disabilities Assistance and Bill of Rights Act
(42 U.S.C. 6042 et seq.).4
(3) State
The term ‘‘State’’, unless otherwise specified, means the several States of the United
States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands.
(July 1, 1944, ch. 373, title XII, § 1253, as added
Pub. L. 106–310, div. A, title XIII, § 1305, Oct. 17,
2000, 114 Stat. 1141; amended Pub. L. 110–206,
§ 6(b), Apr. 28, 2008, 122 Stat. 717.)
REFERENCES IN TEXT
The Developmental Disabilities Assistance and Bill of
Rights Act of 2000, referred to in subsec. (k), is Pub. L.
106–402, Oct. 30, 2000, 114 Stat. 1677. Subtitle C of the Act
probably means subtitle C of title I of the Act, which
is classified generally to part C (§ 15041 et seq.) of subchapter I of chapter 144 of this title. For complete classification of this Act to the Code, see Short Title note
set out under section 15001 of this title and Tables.
The Developmental Disabilities Assistance and Bill of
Rights Act, referred to in subsec. (m)(1), (2), is title I of
Pub. L. 88–164, as added by Pub. L. 98–527, § 2, Oct. 19,
1984, 98 Stat. 2662, which was repealed by Pub. L.
2 So

in original. Probably should be followed by ‘‘of’’.
in original. Probably should be followed by ‘‘and’’.
4 See References in Text note below.
3 So

Page 936

106–402, title IV, § 401(a), Oct. 30, 2000, 114 Stat. 1737.
Part C of the Act was classified generally to subchapter
III (§ 6041 et seq.) of chapter 75 of this title. For complete classification of this Act to the Code, see Tables.
AMENDMENTS
2008—Subsecs. (d), (e). Pub. L. 110–206, § 6(b)(1), substituted ‘‘subsection (l)’’ for ‘‘subsection (i)’’ wherever
appearing.
Subsec. (g). Pub. L. 110–206, § 6(b)(2), inserted ‘‘each
fiscal year not later than October 1,’’ before ‘‘the Administrator shall pay’’.
Subsecs. (i) to (k). Pub. L. 110–206, § 6(b)(4), added subsecs. (i) to (k). Former subsecs. (i) and (j) redesignated
(l) and (m), respectively.
Subsec. (l). Pub. L. 110–206, § 6(b)(3), (5), redesignated
subsec. (i) as (l) and substituted ‘‘2009 through 2012’’ for
‘‘2002 through 2005’’.
Subsec. (m). Pub. L. 110–206, § 6(b)(3), redesignated
subsec. (j) as (m).

PART F—INTERAGENCY PROGRAM FOR TRAUMA
RESEARCH
§ 300d–61. Establishment of Program
(a) In general
The Secretary, acting through the Director of
the National Institutes of Health (in this section
referred to as the ‘‘Director’’), shall establish a
comprehensive program of conducting basic and
clinical research on trauma (in this section referred to as the ‘‘Program’’). The Program shall
include research regarding the diagnosis, treatment, rehabilitation, and general management
of trauma.
(b) Plan for Program
(1) In general
The Director, in consultation with the Trauma Research Interagency Coordinating Committee established under subsection (g) of this
section, shall establish and implement a plan
for carrying out the activities of the Program,
including the activities described in subsection (d) of this section. All such activities
shall be carried out in accordance with the
plan. The plan shall be periodically reviewed,
and revised as appropriate.
(2) Submission to Congress
Not later than December 1, 1993, the Director
shall submit the plan required in paragraph (1)
to the Committee on Energy and Commerce of
the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions of the Senate, together with an estimate
of the funds needed for each of the fiscal years
1994 through 1996 to implement the plan.
(c) Participating agencies; coordination and collaboration
The Director—
(1) shall provide for the conduct of activities
under the Program by the Directors of the
agencies of the National Institutes of Health
involved in research with respect to trauma;
(2) shall ensure that the activities of the
Program are coordinated among such agencies; and
(3) shall, as appropriate, provide for collaboration among such agencies in carrying out
such activities.
(d) Certain activities of Program
The Program shall include—

Page 937

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§ 300d–61

(1) studies with respect to all phases of trauma care, including prehospital, resuscitation,
surgical intervention, critical care, infection
control, wound healing, nutritional care and
support, and medical rehabilitation care;
(2) basic and clinical research regarding the
response of the body to trauma and the acute
treatment and medical rehabilitation of individuals who are the victims of trauma;
(3) basic and clinical research regarding
trauma care for pediatric and geriatric patients; and
(4) the authority to make awards of grants
or contracts to public or nonprofit private entities for the conduct of basic and applied research regarding traumatic brain injury,
which research may include—
(A) the development of new methods and
modalities for the more effective diagnosis,
measurement of degree of brain injury, postinjury monitoring and prognostic assessment of head injury for acute, subacute and
later phases of care;
(B) the development, modification and
evaluation of therapies that retard, prevent
or reverse brain damage after acute head injury, that arrest further deterioration following injury and that provide the restitution of function for individuals with longterm injuries;
(C) the development of research on a continuum of care from acute care through rehabilitation, designed, to the extent practicable, to integrate rehabilitation and longterm outcome evaluation with acute care research;
(D) the development of programs that increase the participation of academic centers
of excellence in brain injury treatment and
rehabilitation research and training; and
(E) carrying out subparagraphs (A)
through (D) with respect to cognitive disorders and neurobehavioral consequences
arising from traumatic brain injury, including the development, modification, and evaluation of therapies and programs of rehabilitation toward reaching or restoring normal
capabilities in areas such as reading, comprehension, speech, reasoning, and deduction.

(2) Duties
The Coordinating Committee shall make
recommendations regarding—
(A) the activities of the Program to be carried out by each of the agencies represented
on the Committee and the amount of funds
needed by each of the agencies for such activities; and
(B) effective collaboration among the
agencies in carrying out the activities.
(3) Composition
The Coordinating Committee shall be composed of the Directors of each of the agencies
that, under subsection (c) of this section, have
responsibilities under the Program, and any
other individuals who are practitioners in the
trauma field as designated by the Director of
the National Institutes of Health.
(h) Definitions
For purposes of this section:
(1) The term ‘‘designated trauma center’’ has
the meaning given such term in section
300d–31(1) of this title.
(2) The term ‘‘Director’’ means the Director
of the National Institutes of Health.
(3) The term ‘‘trauma’’ means any serious
injury that could result in loss of life or in significant disability and that would meet prehospital triage criteria for transport to a designated trauma center.
(4) The term ‘‘traumatic brain injury’’
means an acquired injury to the brain. Such
term does not include brain dysfunction
caused by congenital or degenerative disorders, nor birth trauma, but may include
brain injuries caused by anoxia due to trauma.
The Secretary may revise the definition of
such term as the Secretary determines necessary, after consultation with States and
other appropriate public or nonprofit private
entities.
(i) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2001 through 2005, and such sums as may
be necessary for each of the fiscal years 2009
through 2012.

(e) Mechanisms of support
In carrying out the Program, the Director,
acting through the Directors of the agencies referred to in subsection (c)(1) of this section, may
make grants to public and nonprofit entities, including designated trauma centers.

(July 1, 1944, ch. 373, title XII, § 1261, as added
Pub. L. 103–43, title III, § 303(a), June 10, 1993, 107
Stat. 151; amended Pub. L. 104–166, § 2, July 29,
1996, 110 Stat. 1445; Pub. L. 106–310, div. A, title
XIII, § 1303, Oct. 17, 2000, 114 Stat. 1138; Pub. L.
110–206, § 5, Apr. 28, 2008, 122 Stat. 716.)

(f) Resources
The Director shall assure the availability of
appropriate resources to carry out the Program,
including the plan established under subsection
(b) of this section (including the activities described in subsection (d) of this section).
(g) Coordinating Committee
(1) In general
There shall be established a Trauma Research Interagency Coordinating Committee
(in this section referred to as the ‘‘Coordinating Committee’’).

AMENDMENTS
2008—Subsec. (b)(2). Pub. L. 110–206, § 5(1), substituted
‘‘Health, Education, Labor, and Pensions’’ for ‘‘Labor
and Human Resources’’.
Subsec. (d)(4)(D). Pub. L. 110–206, § 5(2), substituted
‘‘brain injury’’ for ‘‘head brain injury’’.
Subsec. (i). Pub. L. 110–206, § 5(3), inserted ‘‘, and such
sums as may be necessary for each of the fiscal years
2009 through 2012’’ before period at end.
2000—Subsec. (d)(4)(A). Pub. L. 106–310, § 1303(a)(1),
substituted ‘‘degree of brain injury’’ for ‘‘degree of injury’’.
Subsec. (d)(4)(B). Pub. L. 106–310, § 1303(a)(2), which directed amendment of subpar. (B) by substituting
‘‘acute brain injury’’ for ‘‘acute injury’’, could not be

§ 300d–71

TITLE 42—THE PUBLIC HEALTH AND WELFARE

executed because the phrase ‘‘acute injury’’ does not
appear in text.
Subsec. (d)(4)(C). Pub. L. 106–310, § 1303(c)(1), struck
out ‘‘and’’ after semicolon at end.
Subsec. (d)(4)(D). Pub. L. 106–310, § 1303(a)(3), (c)(2),
substituted ‘‘brain injury treatment’’ for ‘‘injury treatment’’ and ‘‘; and’’ for period at end.
Subsec. (d)(4)(E). Pub. L. 106–310, § 1303(c)(3), added
subpar. (E).
Subsec. (h)(4). Pub. L. 106–310, § 1303(b), substituted
‘‘anoxia due to trauma’’ for ‘‘anoxia due to near drowning’’ in second sentence and inserted before period at
end ‘‘, after consultation with States and other appropriate public or nonprofit private entities’’.
Subsec. (i). Pub. L. 106–310, § 1303(d), added subsec. (i).
1996—Subsec. (d)(4). Pub. L. 104–166, § 2(1), added par.
(4).
Subsec. (h)(4). Pub. L. 104–166, § 2(2), added par. (4).
CHANGE OF NAME
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
TRAUMATIC BRAIN INJURY STUDY; CONSENSUS
CONFERENCE
Pub. L. 104–166, § 4, July 29, 1996, 110 Stat. 1448, as
amended by Pub. L. 106–310, div. A, title XIII, § 1302,
Oct. 17, 2000, 114 Stat. 1138, required the Secretary of
Health and Human Services to conduct a study of traumatic brain injuries, to submit a report to Congress
within 18 months of July 29, 1996 on the findings of such
study and a report within 3 years of that date on certain therapeutic interventions and guidelines developed
in the study, and to conduct a national consensus conference on managing traumatic brain injury and related rehabilitation concerns.

PART G—POISON CONTROL
§ 300d–71. Maintenance of the national toll-free
number
(a) In general
The Secretary shall provide coordination and
assistance to poison control centers for the establishment of a nationwide toll-free phone
number, and the maintenance of such number,
to be used to access such centers.
(b) Authorization of appropriations
There is authorized to be appropriated
$2,000,000 for fiscal year 2009 to carry out this
section, and $700,000 for each of fiscal years 2010
through 2014 for the maintenance of the nationwide toll free phone number under subsection
(a).
(July 1, 1944, ch. 373, title XII, § 1271, as added
Pub. L. 108–194, § 3, Dec. 19, 2003, 117 Stat. 2889;
amended Pub. L. 110–377, § 3, Oct. 8, 2008, 122
Stat. 4064.)
AMENDMENTS
2008—Pub. L. 110–377 amended section generally. Prior
to amendment, section required the Secretary to coordinate and assist in establishment of nationwide poison
control center toll-free phone number, allowed for establishment and continued operation of privately fund-

Page 938

ed nationwide toll-free numbers, and authorized appropriations for fiscal years 2000 through 2009.
FINDINGS
Pub. L. 110–377, § 2, Oct. 8, 2008, 122 Stat. 4063, provided
that: ‘‘Congress makes the following findings:
‘‘(1) Poison control centers are the primary defense
of the United States against injury and deaths from
poisoning. Twenty-four hours a day, the general public as well as health care practitioners contact their
local poison control centers for help in diagnosing
and treating victims of poisoning. In 2007, more than
4,000,000 calls were managed by poison control centers
providing ready and direct access for all people of the
United States, including many underserved populations in the United States, with vital emergency
public health information and response.
‘‘(2) Poisoning is the second most common form of
unintentional death in the United States. In any
given year, there will be between 3,000,000 and
5,000,000 poison exposures. Sixty percent of these exposures will involve children under the age of 6 who
are exposed to toxins in their home. Poisoning accounts for 285,000 hospitalizations, 1,200,000 days of
acute hospital care, and more than 26,000 fatalities in
2005.
‘‘(3) In 2008, the Harvard Injury Control Research
Center reported that poisonings from accidents and
unknown circumstances more than tripled in rate
since 1990. In 2005, the last year for which data are
available, 26,858 people died from accidental or unknown poisonings. This represents an increase of
20,000 since 1990 and an increase of 2,400 between 2004
and 2005. Fatalities from poisoning are increasing in
the United States in near epidemic proportions. The
funding of programs to reverse this trend is needed
now more than ever.
‘‘(4) In 2004, The Institute of Medicine of the National Academy of Sciences recommended that ‘Congress should amend the current Poison Control Center Enhancement and Awareness Act Amendments of
2003 [Pub. L. 108–194, see Short Title of 2003 Amendments note set out under section 201 of this title] to
provide sufficient funding to support the proposed
Poison Prevention and Control System with its national network of poison centers. Support for the core
activities at the current level of service is estimated
to require more than $100 million annually.’.
‘‘(5) Sustaining the funding structure and increasing accessibility to poison control centers will promote the utilization of poison control centers and reduce the inappropriate use of emergency medical
services and other more costly health care services.
The 2004 Institute of Medicine Report to Congress determined that for every $1 invested in the Nation’s
poison control centers $7 of health care costs are
saved. In 2005, direct Federal health care program
savings totaled in excess of $525,000,000 as the result
of poison control center public health services.
‘‘(6) More than 30 percent of the cost savings and financial benefits of the Nation’s network of poison
control centers are realized annually by Federal
health care programs (estimated to be more than
$1,000,000,000), yet Federal funding support (as demonstrated by the annual authorization of $30,100,000 in
Public Law 108–194) comprises less than 11 percent of
the annual network expenditures of poison centers.
‘‘(7) Real-time data collected from the Nation’s certified poison control centers can be an important
source of information for the detection, monitoring,
and response for contamination of the air, water,
pharmaceutical, or food supply.
‘‘(8) In the event of a terrorist event, poison control
centers will be relied upon as a critical source for accurate medical information and public health emergency response concerning the treatment of patients
who have had an exposure to a chemical, radiological,
or biological agent.’’
Pub. L. 108–194, § 2, Dec. 19, 2003, 117 Stat. 2888, provided that: ‘‘The Congress finds the following:

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(1) Poison control centers are our Nation’s primary defense against injury and deaths from poisoning. Twenty-four hours a day, the general public as
well as health care practitioners contact their local
poison centers for help in diagnosing and treating
victims of poisoning and other toxic exposures.
‘‘(2) Poisoning is the third most common form of
unintentional death in the United States. In any
given year, there will be between 2,000,000 and
4,000,000 poison exposures. More than 50 percent of
these exposures will involve children under the age of
6 who are exposed to toxic substances in their home.
Poisoning accounts for 285,000 hospitalizations,
1,200,000 days of acute hospital care, and 13,000 fatalities annually.
‘‘(3) Stabilizing the funding structure and increasing accessibility to poison control centers will promote the utilization of poison control centers, and reduce the inappropriate use of emergency medical
services and other more costly health care services.
‘‘(4) The tragic events of September 11, 2001, and the
anthrax cases of October 2001, have dramatically
changed our Nation. During this time period, poison
centers in many areas of the country were answering
thousands of additional calls from concerned residents. Many poison centers were relied upon as a
source for accurate medical information about the
disease and the complications resulting from prophylactic antibiotic therapy.
‘‘(5) The 2001 Presidential Task Force on Citizen
Preparedness in the War on Terrorism recommended
that the Poison Control Centers be used as a source
of public information and public education regarding
potential biological, chemical, and nuclear domestic
terrorism.
‘‘(6) The increased demand placed upon poison centers to provide emergency information in the event of
a terrorist event involving a biological, chemical, or
nuclear toxin will dramatically increase call volume.’’

§ 300d–72. Nationwide media campaign to promote poison control center utilization
(a) In general
The Secretary shall carry out, and expand
upon, a national media campaign to educate the
public and health care providers about poison
prevention and the availability of poison control
center resources in local communities and to
conduct advertising campaigns concerning the
nationwide toll-free number established under
section 300d–71(a) of this title.
(b) Contract with entity
The Secretary may carry out subsection (a) by
entering into contracts with one or more public
or private entities, including nationally recognized organizations in the field of poison control
and national media firms, for the development
and implementation of a nationwide poison prevention and poison control center awareness
campaign, which may include—
(1) the development and distribution of poison prevention and poison control center
awareness materials;
(2) television, radio, Internet, and newspaper
public service announcements; and
(3) other activities to provide for public and
professional awareness and education.
(c) Evaluation
The Secretary shall—
(1) establish baseline measures and benchmarks to quantitatively evaluate the impact
of the nationwide media campaign carried out
under this section; and

§ 300d–73

(2) on an annual basis, prepare and submit to
the appropriate committees of Congress, an
evaluation of the nationwide media campaign.
(d) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, such sums as may be necessary for fiscal year 2009, and $800,000 for each
of fiscal years 2010 through 2014.
(July 1, 1944, ch. 373, title XII, § 1272, as added
Pub. L. 108–194, § 3, Dec. 19, 2003, 117 Stat. 2889;
amended Pub. L. 110–377, § 4(a), Oct. 8, 2008, 122
Stat. 4064.)
AMENDMENTS
2008—Pub. L. 110–377 amended section generally. Prior
to amendment, section required the Secretary to establish a national media campaign to educate the public
and health care providers about poison control and prevention and authorized appropriations for fiscal years
2000 through 2009.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–377, § 4(b), Oct. 8, 2008, 122 Stat. 4065, provided that: ‘‘The amendment made by this section
[amending this section] shall be effective on the date of
the enactment of this Act [Oct. 8, 2008] and shall apply
to contracts entered into on or after January 1, 2009.’’

§ 300d–73. Maintenance of the poison control center grant program
(a) Authorization of program
The Secretary shall award grants to poison
control centers certified under subsection (c) (or
granted a waiver under subsection (d)) and professional organizations in the field of poison
control for the purposes of preventing, and providing
treatment
recommendations
for,
poisonings and complying with the operational
requirements needed to sustain the certification
of the center under subsection (c).
(b) Additional uses of funds
In addition to the purposes described in subsection (a), a poison center or professional organization awarded a grant, contract, or cooperative agreement under such subsection may also
use amounts received under such grant, contract, or cooperative agreement—
(1) to establish and evaluate best practices
in the United States for poison prevention,
poison control center outreach, and emergency and preparedness programs;
(2) to research, develop, implement, revise,
and communicate standard patient management guidelines for commonly encountered
toxic exposures;
(3) to improve national toxic exposure surveillance by enhancing cooperative activities
between poison control centers in the United
States and the Centers for Disease Control and
Prevention;
(4) to develop, support, and enhance technology and capabilities of professional organizations in the field of poison control to collect
national poisoning, toxic occurrence, and related public health data;
(5) to develop initiatives to foster the enhanced public health utilization of national
poison data collected by organizations described in paragraph (4);
(6) to support and expand the toxicologic expertise within poison control centers; and

§ 300d–74

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(7) to improve the capacity of poison control
centers to answer high volumes of calls and respond during times of national crisis or other
public health emergencies.
(c) Certification
Except as provided in subsection (d), the Secretary may award a grant to a poison control
center under subsection (a) only if—
(1) the center has been certified by a professional organization in the field of poison control, and the Secretary has approved the organization as having in effect standards for certification that reasonably provide for the protection of the public health with respect to
poisoning; or
(2) the center has been certified by a State
government, and the Secretary has approved
the State government as having in effect
standards for certification that reasonably
provide for the protection of the public health
with respect to poisoning.
(d) Waiver of certification requirements
(1) In general
The Secretary may grant a waiver of the
certification requirements of subsection (c)
with respect to a noncertified poison control
center that applies for a grant under this section if such center can reasonably demonstrate that the center will obtain such a
certification within a reasonable period of
time as determined appropriate by the Secretary.
(2) Renewal
The Secretary may renew a waiver under
paragraph (1).
(3) Limitation
In no case may the sum of the number of
years for a waiver under paragraph (1) and a
renewal under paragraph (2) exceed 5 years.
The preceding sentence shall take effect as of
October 8, 2008.
(e) Supplement not supplant
Amounts made available to a poison control
center under this section shall be used to supplement and not supplant other Federal, State or
local funds provided for such center.
(f) Maintenance of effort
A poison control center, in utilizing the proceeds of a grant under this section, shall maintain the expenditures of the center for activities
of the center at a level that is not less than the
level of expenditures maintained by the center
for the fiscal year preceding the fiscal year for
which the grant is received.
(g) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $27,500,000 for fiscal year
2009, and $28,600,000 for each of fiscal years 2010
through 2014. The Secretary may utilize not to
exceed 8 percent of the amount appropriated
under this preceding sentence in each fiscal year
for coordination, dissemination, technical assistance, program evaluation, data activities,
and other program administration functions
that do not include grants, contracts, or cooperative agreements under subsections (a) and (b),

Page 940

which are determined by the Secretary to be appropriate for carrying out the program under
this section.
(July 1, 1944, ch. 373, title XII, § 1273, as added
Pub. L. 108–194, § 3, Dec. 19, 2003, 117 Stat. 2889;
amended Pub. L. 110–377, § 5(a), Oct. 8, 2008, 122
Stat. 4065.)
AMENDMENTS
2008—Pub. L. 110–377 amended section generally. Prior
to amendment, section related to awarding of grants to
certified regional poison control centers and additional
uses of appropriated funds by Secretary and authorized
appropriations for fiscal years 2000 through 2009.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–377, § 5(b), Oct. 8, 2008, 122 Stat. 4067, provided that: ‘‘The amendment made by this section
[amending this section] shall be effective as of the date
of the enactment of this Act [Oct. 8, 2008] and shall
apply to grants made on or after January 1, 2009.’’

§ 300d–74. Rule of construction
Nothing in this part may be construed to ease
any restriction in Federal law applicable to the
amount or percentage of funds appropriated to
carry out this part that may be used to prepare
or submit a report.
(July 1, 1944, ch. 373, title XII, § 1274, as added
Pub. L. 108–194, § 3, Dec. 19, 2003, 117 Stat. 2891.)
PART H—TRAUMA SERVICE AVAILABILITY
§ 300d–81. Grants to States
(a) Establishment
To promote universal access to trauma care
services provided by trauma centers and trauma-related physician specialties, the Secretary
shall provide funding to States to enable such
States to award grants to eligible entities for
the purposes described in this section.
(b) Awarding of grants by States
Each State may award grants to eligible entities within the State for the purposes described
in subparagraph (d).
(c) Eligibility
(1) In general
To be eligible to receive a grant under subsection (b) an entity shall—
(A) be—
(i) a public or nonprofit trauma center or
consortium thereof that meets that 1 requirements of paragraphs (1), (2), and (5) of
section 300d–41(b) of this title;
(ii) a safety net public or nonprofit trauma center that meets the requirements of
paragraphs (1) through (5) of section
300d–41(b) of this title; or
(iii) a hospital in an underserved area (as
defined by the State) that seeks to establish new trauma services; and
(B) submit to the State an application at
such time, in such manner, and containing
such information as the State may require.
(2) Limitation
A State shall use at least 40 percent of the
amount available to the State under this part
1 So

in original. Probably should be ‘‘the’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

for a fiscal year to award grants to safety net
trauma centers described in paragraph
(1)(A)(ii).
(d) Use of funds
The recipient of a grant under subsection (b)
shall carry out 1 or more of the following activities consistent with subsection (b):
(1) Providing trauma centers with funding to
support physician compensation in trauma-related physician specialties where shortages
exist in the region involved, with priority provided to safety net trauma centers described
in subsection (c)(1)(A)(ii).
(2) Providing for individual safety net trauma center fiscal stability and costs related to
having service that is available 24 hours a day,
7 days a week, with priority provided to safety
net trauma centers described in subsection
(c)(1)(A)(ii) located in urban, border, and rural
areas.
(3) Reducing trauma center overcrowding at
specific trauma centers related to throughput
of trauma patients.
(4) Establishing new trauma services in underserved areas as defined by the State.
(5) Enhancing collaboration between trauma
centers and other hospitals and emergency
medical services personnel related to trauma
service availability.
(6) Making capital improvements to enhance
access and expedite trauma care, including
providing helipads and associated safety infrastructure.
(7) Enhancing trauma surge capacity at specific trauma centers.
(8) Ensuring expedient receipt of trauma patients transported by ground or air to the appropriate trauma center.
(9) Enhancing interstate trauma center collaboration.
(e) Limitation
(1) In general
A State may use not more than 20 percent of
the amount available to the State under this
part for a fiscal year for administrative costs
associated with awarding grants and related
costs.
(2) Maintenance of effort
The Secretary may not provide funding to a
State under this part unless the State agrees
that such funds will be used to supplement and
not supplant State funding otherwise available for the activities and costs described in
this part.
(f) Distribution of funds
The following shall apply with respect to
grants provided in this part:
(1) Less than $10,000,000
If the amount of appropriations for this part
in a fiscal year is less than $10,000,000, the Secretary shall divide such funding evenly among
only those States that have 1 or more trauma
centers eligible for funding under section
300d–41(b)(3)(A) of this title.
(2) Less than $20,000,000
If the amount of appropriations in a fiscal
year is less than $20,000,000, the Secretary

§ 300e

shall divide such funding evenly among only
those States that have 1 or more trauma centers eligible for funding under subparagraphs
(A) and (B) of section 300d–41(b)(3) of this title.
(3) Less than $30,000,000
If the amount of appropriations for this part
in a fiscal year is less than $30,000,000, the Secretary shall divide such funding evenly among
only those States that have 1 or more trauma
centers eligible for funding under section
300d–41(b)(3) of this title.
(4) $30,000,000 or more
If the amount of appropriations for this part
in a fiscal year is $30,000,000 or more, the Secretary shall divide such funding evenly among
all States.
(July 1, 1944, ch. 373, title XII, § 1281, as added
Pub. L. 111–148, title III, § 3505(b), Mar. 23, 2010,
124 Stat. 525.)
§ 300d–82. Authorization of appropriations
For the purpose of carrying out this part,
there is authorized to be appropriated
$100,000,000 for each of fiscal years 2010 through
2015.
(July 1, 1944, ch. 373, title XII, § 1282, as added
Pub. L. 111–148, title III, § 3505(b), Mar. 23, 2010,
124 Stat. 527.)
SUBCHAPTER XI—HEALTH MAINTENANCE
ORGANIZATIONS
§ 300e. Requirements of health maintenance organizations
(a) ‘‘Health maintenance organization’’ defined
For purposes of this subchapter, the term
‘‘health maintenance organization’’ means a
public or private entity which is organized
under the laws of any State and which (1) provides basic and supplemental health services to
its members in the manner prescribed by subsection (b) of this section, and (2) is organized
and operated in the manner prescribed by subsection (c) of this section.
(b) Manner of supplying basic and supplemental
health services to members
A health maintenance organization shall provide, without limitations as to time or cost
other than those prescribed by or under this subchapter, basic and supplemental health services
to its members in the following manner:
(1) Each member is to be provided basic
health services for a basic health services payment which (A) is to be paid on a periodic
basis without regard to the dates health services (within the basic health services) are provided; (B) is fixed without regard to the frequency, extent, or kind of health service
(within the basic health services) actually furnished; (C) except in the case of basic health
services provided a member who is a full-time
student (as defined by the Secretary) at an accredited institution of higher education, is
fixed under a community rating system; and
(D) may be supplemented by additional nominal payments which may be required for the
provision of specific services (within the basic

§ 300e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health services), except that such payments
may not be required where or in such a manner that they serve (as determined under regulations of the Secretary) as a barrier to the delivery of health services. Such additional
nominal payments shall be fixed in accordance
with the regulations of the Secretary. If a
health maintenance organization offers to its
members the opportunity to obtain basic
health services through a physician not described in subsection (b)(3)(A) of this section,
the organization may require, in addition to
payments described in clause (D) of this paragraph, a reasonable deductible to be paid by a
member when obtaining a basic health service
from such a physician. A health maintenance
organization may include a health service, defined as a supplemental health service by section 300e–1(2) of this title, in the basic health
services provided its members for a basic
health services payment described in the first
sentence. In the case of an entity which before
it became a qualified health maintenance organization (within the meaning of section
300e–9(d) 1 of this title) provided comprehensive
health services on a prepaid basis, the requirement of clause (C) shall not apply to such entity until the expiration of the forty-eight
month period beginning with the month following the month in which the entity became
such a qualified health organization. The requirements of this paragraph respecting the
basic health services payment shall not apply
to the provision of basic health services to a
member for an illness or injury for which the
member is entitled to benefits under a workmen’s compensation law or an insurance policy but only to the extent such benefits apply
to such services. For the provision of such
services for an illness or injury for which a
member is entitled to benefits under such a
law, the health maintenance organization
may, if authorized by such law, charge or authorize the provider of such services to charge,
in accordance with the charges allowed under
such law, the insurance carrier, employer, or
other entity which under such law is to pay
for the provision of such services or, to the extent that such member has been paid under
such law for such services, such member. For
the provision of such services for an illness or
injury for which a member is entitled to benefits under an insurance policy, a health maintenance organization may charge or authorize
the provider of such services to charge the insurance carrier under such policy or, to the extent that such member has been paid under
such policy for such services, such member.
(2) For such payment or payments (hereinafter in this subchapter referred to as ‘‘supplemental health services payments’’) as the
health maintenance organization may require
in addition to the basic health services payment, the organization may provide to each of
its members any of the health services which
are included in supplemental health services
(as defined in section 300e–1(2) of this title).
Supplemental health services payments which
are fixed on a prepayment basis shall be fixed
1 See

References in Text note below.

Page 942

under a community rating system unless the
supplemental health services payment is for a
supplemental health service provided a member who is a full-time student (as defined by
the Secretary) at an accredited institution of
higher education, except that, in the case of
an entity which before it became a qualified
health maintenance organization (within the
meaning of section 300e–9(d) 1 of this title) provided comprehensive health services on a prepaid basis, the requirement of this sentence
shall not apply to such entity during the
forty-eight month period beginning with the
month following the month in which the entity became such a qualified health maintenance organization.
(3)(A) Except as provided in subparagraph
(B), at least 90 percent of the services of a physician which are provided as basic health services shall be provided through—
(i) members of the staff of the health
maintenance organization,
(ii) a medical group (or groups),
(iii) an individual practice association (or
associations),
(iv) physicians or other health professionals who have contracted with the health
maintenance organization for the provision
of such services, or
(v) any combination of such staff, medical
group (or groups), individual practice association (or associations) or physicians or
other health professionals under contract
with the organization.
(B) Subparagraph (A) does not apply to the
provision of the services of a physician—
(i) which the health maintenance organization determines, in conformity with regulations of the Secretary, are unusual or infrequently used, or
(ii) which are provided a member of the organization in a manner other than that prescribed by subparagraph (A) because of an
emergency which made it medically necessary that the service be provided to the
member before it could be provided in a
manner prescribed by subparagraph (A).
(C) Contracts between a health maintenance
organization and health professionals for the
provision of basic and supplemental health
services shall include such provisions as the
Secretary may require, but only to the extent
that such requirements are designed to insure
the delivery of quality health care services
and sound fiscal management.
(D) For purposes of this paragraph the term
‘‘health professional’’ means physicians, dentists, nurses, podiatrists, optometrists, and
such other individuals engaged in the delivery
of health services as the Secretary may by
regulation designate.
(4) Basic health services (and only such supplemental health services as members have
contracted for) shall within the area served by
the health maintenance organization be available and accessible to each of its members
with reasonable promptness and in a manner
which assures continuity, and when medically
necessary be available and accessible twentyfour hours a day and seven days a week, except

Page 943

TITLE 42—THE PUBLIC HEALTH AND WELFARE

that a health maintenance organization which
has a service area located wholly in a nonmetropolitan area may make a basic health
service available outside its service area if
that basic health service is not a primary care
or emergency health care service and if there
is an insufficient number of providers of that
basic health service within the service area
who will provide such service to members of
the health maintenance organization. A member of a health maintenance organization shall
be reimbursed by the organization for his expenses in securing basic and supplemental
health services other than through the organization if the services were medically necessary
and immediately required because of an unforeseen illness, injury, or condition.
(5) To the extent that a natural disaster,
war, riot, civil insurrection, or any other similar event not within the control of a health
maintenance organization (as determined
under regulations of the Secretary) results in
the facilities, personnel, or financial resources
of a health maintenance organization not
being available to provide or arrange for the
provision of a basic or supplemental health
service in accordance with the requirements of
paragraphs (1) through (4) of this subsection,
such requirements only require the organization to make a good-faith effort to provide or
arrange for the provision of such service within such limitation on its facilities, personnel,
or resources.
(6) A health maintenance organization that
otherwise meets the requirements of this subchapter may offer a high-deductible health
plan (as defined in section 220(c)(2) of title 26).
(c) Organizational requirements
Each health maintenance organization shall—
(1)(A) have—
(i) a fiscally sound operation, and
(ii) adequate provision against the risk of
insolvency,
which is satisfactory to the Secretary, and (B)
have administrative and managerial arrangements satisfactory to the Secretary;
(2) assume full financial risk on a prospective basis for the provision of basic health
services, except that a health maintenance organization may (A) obtain insurance or make
other arrangements for the cost of providing
to any member basic health services the aggregate value of which exceeds $5,000 in any
year, (B) obtain insurance or make other arrangements for the cost of basic health services provided to its members other than
through the organization because medical necessity required their provision before they
could be secured through the organization, (C)
obtain insurance or make other arrangements
for not more than 90 per centum of the amount
by which its costs for any of its fiscal years
exceed 115 per centum of its income for such
fiscal year, and (D) make arrangements with
physicians or other health professionals,
health care institutions, or any combination
of such individuals or institutions to assume
all or part of the financial risk on a prospective basis for the provision of basic health
services by the physicians or other health professionals or through the institutions;

§ 300e

(3)(A) enroll persons who are broadly representative of the various age, social, and income groups within the area it serves, except
that in the case of a health maintenance organization which has a medically underserved
population located (in whole or in part) in the
area it serves, not more than 75 per centum of
the members of that organization may be enrolled from the medically underserved population unless the area in which such population resides is also a rural area (as designated by the Secretary), and (B) carry out
enrollment of members who are entitled to
medical assistance under a State plan approved under title XIX of the Social Security
Act [42 U.S.C. 1396 et seq.] in accordance with
procedures approved under regulations promulgated by the Secretary;
(4) not expel or refuse to re-enroll any member because of his health status or his requirements for health services;
(5) be organized in such a manner that provides meaningful procedures for hearing and
resolving grievances between the health maintenance organization (including the medical
group or groups and other health delivery entities providing health services for the organization) and the members of the organization;
(6) have organizational arrangements, established in accordance with regulations of the
Secretary, for an ongoing quality assurance
program for its health services which program
(A) stresses health outcomes, and (B) provides
review by physicians and other health professionals of the process followed in the provision
of health services;
(7) adopt at least one of the following arrangements to protect its members from incurring liability for payment of any fees which
are the legal obligation of such organization—
(A) a contractual arrangement with any
hospital that is regularly used by the members of such organization prohibiting such
hospital from holding any such member liable for payment of any fees which are the
legal obligation of such organization;
(B) insolvency insurance, acceptable to the
Secretary;
(C) adequate financial reserve, acceptable
to the Secretary; and
(D) other arrangements, acceptable to the
Secretary, to protect members,
except that the requirements of this paragraph shall not apply to a health maintenance
organization if applicable State law provides
the members of such organization with protection from liability for payment of any fees
which are the legal obligation of such organization; and
(8) provide, in accordance with regulations
of the Secretary (including safeguards concerning the confidentiality of the doctor-patient relationship), and effective procedure for
developing, compiling, evaluating, and reporting to the Secretary, statistics and other information (which the Secretary shall publish
and disseminate on an annual basis and which
the health maintenance organization shall disclose, in a manner acceptable to the Secretary, to its members and the general public)
relating to (A) the cost of its operations, (B)

§ 300e

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the patterns of utilization of its services, (C)
the availability, accessibility, and acceptability of its services, (D) to the extent practical, developments in the health status of its
members, and (E) such other matters as the
Secretary may require.
The Secretary shall issue regulations stating
the circumstances under which the Secretary, in
administering paragraph (1)(A), will consider the
resources of an organization which owns or controls a health maintenance organization. Such
regulations shall require as a condition to consideration of resources that an organization
which owns or controls a health maintenance
organization shall provide satisfactory assurances that it will assume the financial obligations of the health maintenance organization.
(d) Application of rules by certain health maintenance organizations
An organization that offers health benefits
coverage shall not be considered as failing to
meet the requirements of this section notwithstanding that it provides, with respect to coverage offered in connection with a group health
plan in the small or large group market (as defined in section 300gg–91(e) of this title), an affiliation period consistent with the provisions of
section 2701(g).1
(July 1, 1944, ch. 373, title XIII, § 1301, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 914;
amended Pub. L. 94–460, title I, §§ 101, 102(a), 103,
105(a), Oct. 8, 1976, 90 Stat. 1945–1947; Pub. L.
95–559, §§ 9(b), 10, 11(a)–(d), Nov. 1, 1978, 92 Stat.
2137–2139; Pub. L. 96–32, § 2(b), July 10, 1979, 93
Stat. 82; Pub. L. 97–35, title IX, § 942(a)(1), (2),
(b)–(e), Aug. 13, 1981, 95 Stat. 573, 574; Pub. L.
100–517, §§ 2–4(a), 5(a)(1), (2), (b), Oct. 24, 1988, 102
Stat. 2578, 2579; Pub. L. 104–191, title I, §§ 102(b),
193, Aug. 21, 1996, 110 Stat. 1976, 1988.)
REFERENCES IN TEXT
Section 300e–9(d) of this title, referred to in subsec.
(b)(1), (2), was redesignated section 300e–9(c) of this
title by Pub. L. 100–517, § 7(b), Oct. 24, 1988, 102 Stat.
2580.
The Social Security Act, referred to in subsec.
(c)(3)(B), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title
XIX of the Social Security Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
Section 2701, referred to in subsec. (d), is a reference
to section 2701 of act July 1, 1944. Section 2701, which
was classified to section 300gg of this title, was renumbered section 2704, effective for plan years beginning on
or after Jan. 1, 2014, with certain exceptions, and
amended, by Pub. L. 111–148, title I, §§ 1201(2), 1563(c)(1),
formerly § 1562(c)(1), title X, § 10107(b)(1), Mar. 23, 2010,
124 Stat. 154, 264, 911, and was transferred to section
300gg–3 of this title. A new section 2701 of act July 1,
1944, related to fair health insurance premiums, was
added, effective for plan years beginning on or after
Jan. 1, 2014, and amended, by Pub. L. 111–148, title I,
§ 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
CODIFICATION
Amendment to subsec. (b)(3)(D) by section 942(b)(2) of
Pub. L. 97–35 was executed before redesignation by section 942(a)(1)(B) of Pub. L. 97–35, to reflect the probable
intent of Congress.
AMENDMENTS
1996—Subsec. (b)(6). Pub. L. 104–191, § 193, added par.
(6).

Page 944

Subsec. (d). Pub. L. 104–191, § 102(b), added subsec. (d).
1988—Subsec. (a). Pub. L. 100–517, § 2, substituted
‘‘public or private entity which is organized under the
laws of any State and’’ for ‘‘legal entity’’.
Subsec. (b)(1). Pub. L. 100–517, § 3, inserted after second sentence ‘‘If a health maintenance organization offers to its members the opportunity to obtain basic
health services through a physician not described in
subsection (b)(3)(A) of this section, the organization
may require, in addition to payments described in
clause (D) of this paragraph, a reasonable deductible to
be paid by a member when obtaining a basic health
service from such a physician.’’
Subsec. (b)(3)(A). Pub. L. 100–517, § 4(a), substituted
‘‘at least 90 percent of the services of a physician’’ for
‘‘the services of a physician’’.
Subsec. (c). Pub. L. 100–517, § 5(a)(2), inserted at end
‘‘The Secretary shall issue regulations stating the circumstances under which the Secretary, in administering paragraph (1)(A), will consider the resources of an
organization which owns or controls a health maintenance organization. Such regulations shall require as a
condition to consideration of resources that an organization which owns or controls a health maintenance organization shall provide satisfactory assurances that it
will assume the financial obligations of the health
maintenance organization.’’
Subsec. (c)(1)(A). Pub. L. 100–517, § 5(a)(1), amended
subpar. (A) generally. Prior to amendment, subpar. (A)
read as follows: ‘‘have a fiscally sound operation and
adequate provision against the risk of insolvency which
is satisfactory to the Secretary, and’’.
Subsec. (c)(5) to (9). Pub. L. 100–517, § 5(b), redesignated pars. (6) to (9) as (5) to (8), respectively, and
struck out former par. (5) which read as follows: ‘‘(A) in
the case of a private health maintenance organization,
be organized in such a manner that assures that (i) at
least one-third of the membership of the policymaking
body of the health maintenance organization will be
members of the organization, and (ii) there will be
equitable representation on such body of members from
medically underserved populations served by the organization, and (B) in the case of a public health maintenance organization, have an advisory board to the policymaking body of the public entity operating the organization which board meets the requirements of
clause (A) of this paragraph and to which may be delegated policymaking authority for the organization;’’.
1981—Subsec. (b)(3)(A)(iv). Pub. L. 97–35, § 942(a)(2),
substituted ‘‘physicians’’ for ‘‘subject to subparagraph
(C), physicians’’.
Subsec. (b)(3)(B). Pub. L. 97–35, § 942(b)(1), substituted
‘‘(B)’’ for ‘‘(B)(i)’’, ‘‘(i)’’ for ‘‘(I)’’, and ‘‘(ii)’’ for ‘‘(II)’’
and struck out former cl. (ii) which related to the
forty-eight-month period beginning after the month of
qualification of a health maintenance organization.
Subsec. (b)(3)(C). Pub. L. 97–35, § 942(a)(1), redesignated subpar. (D) as (C) and struck out former subpar.
(C) which related to the expiration of the first four fiscal years as a qualified organization.
Subsec. (b)(3)(D). Pub. L. 97–35, § 942(b)(2), amended
subpar. (D) generally. Prior to amendment, subpar. (D)
read as follows: ‘‘Contracts between a health maintenance organization and health professionals for the
provision of basic and supplemental health services
shall include such provisions as the Secretary may require (including provisions requiring appropriate continuing education).’’ See Codification note above.
Pub. L. 97–35, § 942(a)(1)(B), redesignated subpar. (E)
as (D). Former subpar. (D) redesignated (C).
Subsec. (b)(4). Pub. L. 97–35, § 942(c), substituted ‘‘with
reasonable promptness’’ for ‘‘promptly as appropriate’’
and inserted ‘‘, except that a health maintenance organization which has a service area located wholly in a
nonmetropolitan area may make a basic health service
available outside its service area if that basic health
service is not a primary care or emergency health care
service and if there is an insufficient number of providers of that basic health service within the service area
who will provide such service to members of the health
maintenance organization’’ after ‘‘week’’.

Page 945

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (c). Pub. L. 97–35, § 942(d)(1), (e), in par. (2)
substituted provisions specifying requirements with respect to insurance, etc., for provisions generalizing
such insurance, etc., requirements, and added cl. (D),
struck out par. (4) which related to open enrollment period, redesignated pars. (5) to (8) as (4) to (7), respectively, added par. (8), struck out pars. (9) and (10) which
related to medical social and health education services,
and continuing education, respectively, and redesignated par. (11) as (9).
Subsec. (d). Pub. L. 97–35, § 942(d)(2), struck out subsec. (d) which related to requirements, etc., respecting
open enrollment period.
1979—Subsec. (b)(3). Pub. L. 96–32 amended directory
language of section 11(a) of Pub. L. 95–559 by substituting reference to section ‘‘1301’’ for ‘‘1310’’ of the Public
Health Service Act, as section to be amended, and required no change in text because amendment made by
Pub. L. 95–559 had been executed to this section as the
probable intent of Congress.
1978—Subsec. (b)(1). Pub. L. 95–559, §§ 10(a), 11(b), inserted ‘‘except in the case of basic health services provided a member who is a full-time student (as defined
by the Secretary) at an accredited institution of higher
education,’’ after ‘‘the requirement of clause (C)’’ and
inserted provisions permitting the health maintenance
organization to seek reimbursement for the cost of
services provided to a member who is entitled to benefits under a workmen’s compensation law or insurance
policy.
Subsec. (b)(2). Pub. L. 95–559, § 10(a), inserted ‘‘unless
the supplemental health services payment is for a supplemental health service provided a member who is a
full-time student (as defined by the Secretary) at an
accredited institution of higher education,’’ after
‘‘community rating system’’.
Subsec. (b)(3). Pub. L. 95–559, § 11(a), as amended by
Pub. L. 96–32, inserted provisions limiting the health
maintenance organization from entering into contracts
for health services with physicians other than members
of the staff of the health maintenance organization,
medical groups, or individual practice associations.
Subsec. (b)(4). Pub. L. 95–559, § 11(c), substituted
‘‘basic and supplemental’’ for ‘‘basic or supplemental’’
and ‘‘if the services were medically necessary and immediately required because of an unforeseen illness, injury, or condition’’ for ‘‘if it was medically necessary
that the services be provided before it could secure
them through the organization’’.
Subsec. (b)(5). Pub. L. 95–559, § 11(d), added par. (5).
Subsec. (c)(1). Pub. L. 95–559, § 10(b), designated existing provisions as subpar. (A) and added subpar. (B).
Subsec. (c)(3). Pub. L. 95–559, § 9(b), designated existing provisions as subpar. (A) and added subpar. (B).
Subsec. (c)(6). Pub. L. 95–559, § 10(c), designated existing provisions as subpar. (A), inserted ‘‘in the case of a
private health maintenance organization,’’ before ‘‘be
organized in such’’, and substituted ‘‘(i)’’ for ‘‘(A)’’ and
‘‘(ii)’’ for ‘‘(B)’’, and added subpar. (B).
1976—Subsec. (b)(1). Pub. L. 94–460, §§ 101(a), 105(a)(1),
provided that a health maintenance organization may
include a health service, defined as a supplemental
health service by section 300e–1(2) of this title, in the
basic health services provided its members for a basic
health service payment described in the first sentence,
and also provided that, in the case of an entity which
before it became a qualified health maintenance organization (within the meaning of section 300e–9(d) of this
title) provided comprehensive health services on a prepaid basis, the requirement of clause (C) would not
apply to such entity until the expiration of the fortyeight month period beginning with the month following
the month in which the entity became such a qualified
health organization.
Subsec. (b)(2). Pub. L. 94–460, §§ 101(b), 105(a)(2), substituted ‘‘the organization may provide to each of its
members any of the health services which are included
in supplemental health services (as defined in section
300e–1(2) of this title)’’ for ‘‘the organization shall provide to each of its members each health service (A)

§ 300e

which is included in supplemental health services (as
defined in section 300e–1(2) of this title), (B) for which
the required health manpower are available in the area
served by the organization, and (C) for the provision of
which the member has contracted with the organization’’ and inserted ‘‘except that, in the case of an entity which before it became a qualified health maintenance organization (within the meaning of section
300e–9(d) of this title) provided comprehensive health
services on a prepaid basis, the requirement of this sentence shall not apply to such entity during the fortyeight month period beginning with the month following
the month in which the entity became such a qualified
health maintenance organization’’ after ‘‘Supplemental
health services payments which are fixed on a prepayment basis shall be fixed under a community rating
system’’.
Subsec. (b)(3). Pub. L. 94–460, § 102(a), inserted references to health professionals who have contracted
with the health maintenance organization for the provision of such services and to the combination of staff,
medical groups, individual practice associations, or
health professionals under contract with the health
maintenance organization, and inserted provisions allowing a health maintenance organization, during the
thirty-six month period beginning with the month following the month in which the organization becomes a
qualified health maintenance organization (within the
meaning of section 300e–9(d) of this title), to provide
basic and supplemental health services through an entity which but for the requirement of section
300e–1(4)(C)(i) of this title would be a medical group for
purposes of this subchapter, directing that after the expiration of such period, the organization may provide
basic or supplemental health services through such an
entity only if authorized by the Secretary in accordance with regulations which take into consideration
the unusual circumstances of such entity, directing
that a health maintenance organization may not, in
any of its fiscal years, enter into contracts with health
professionals or entities other than medical groups or
individual practice associations if the amounts paid
under such contracts for basic and supplemental health
services exceed fifteen percent of the total amount to
be paid in such fiscal year by the health maintenance
organization to physicians for the provision of basic
and supplemental health services, or, if the health
maintenance organization principally serves a rural
area, thirty percent of such amount, except that the
sentence would not apply to the entering into of contracts for the purchase of basic and supplemental
health services through an entity which but for the requirements of section 300e–1(4)(C)(i) of this title would
be a medical group for purposes of this subchapter, and
directing that contracts between a health maintenance
organization and health professionals for the provision
of basic and supplemental health services include such
provisions as the Secretary may require (including provisions requiring appropriate continuing education).
Subsec. (b)(4). Pub. L. 94–460, § 101(c), substituted ‘‘and
only such supplemental health services as members
have contracted for’’ for ‘‘and supplemental health
services in the case of the members who have contracted therefor’’.
Subsec. (c)(4). Pub. L. 94–460, § 103(a), substituted provisions making a simple reference to an open enrollment period in accordance with the provisions of subsec. (d) of this section for provisions spelling out in detail the requirements for a health maintenance organization with regard to an open enrollment period.
Subsec. (d). Pub. L. 94–460, § 103(b), added subsec. (d).
EFFECTIVE DATE OF 1976 AMENDMENT
Pub. L. 94–460, title I, § 118, Oct. 8, 1976, 90 Stat. 1955,
provided that:
‘‘(a) Except as provided in subsection (b), the amendments made by this title [enacting section 300e–15 of
this title and amending this section, sections 300e–1 to
300e–11, 300e–13, and 300n–1 of this title, and section 8902
of Title 5, Government Organization and Employees]

§ 300e–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall take effect on the date of the enactment of this
Act [Oct. 8, 1976].
‘‘(b)(1) The amendments made by sections 101 [amending this section], 102 [amending this section and section
300e–1 of this title], 103 [amending this section], 104
[amending section 300e–1 of this title], and 106 [amending section 300e–1 of this title] shall (A) apply with respect to grants, contracts, loans, and loan guarantees
made under sections 1303, 1304, and 1305 of the Public
Health Service Act [sections 300e–2, 300e–3, and 300e–4 of
this title] for fiscal years beginning after September 30,
1976, (B) apply with respect to health benefit plans offered under section 1310 of such Act [section 300e–9 of
this title] after such date, and (C) for purposes of section 1312 [section 300e–11 of this title] take effect October 1, 1976.
‘‘(2) Subsection (d) of section 1301 of the Public
Health Service Act [subsec. (d) of this section] (added
by section 103(b) of this Act) shall take effect with respect to fiscal years of health maintenance organizations beginning on or after the date of the enactment
of this Act [Oct. 8, 1976].
‘‘(3) The amendments made by section 107 [amending
sections 300e–2, 300e–3, and 300e–4 of this title] shall
apply with respect to grants, contracts, loans, and loan
guarantees made under sections 1303, 1304, and 1305 of
the Public Health Service Act [sections 300e–2, 300e–3
and 300e–4 of this title] for fiscal years beginning after
September 30, 1976.
‘‘(4) The amendments made by sections 109(a)(1)
[amending section 300e–4 of this title] and 109(c)
[amending section 300e–7 of this title] shall apply with
respect to loan guarantees made under section 1305 of
the Public Health Service Act [section 300e–4 of this
title] after September 30, 1976.
‘‘(5) The amendment made by section 109(e) [amending section 300e–3 of this title] shall apply with respect
to projects assisted under section 1304 of the Public
Health Service Act [section 300e–3 of this title] after
September 30, 1976.
‘‘(6) The amendments made by paragraphs (1) and (2)
of section 110(a) [amending section 300e–9 of this title]
shall apply with respect to calendar quarters which
begin after the date of the enactment of this Act [Oct.
8, 1976].
‘‘(7) The amendments made by paragraphs (3) and (4)
of section 110 [amending section 300e–9 of this title]
shall apply with respect to failures of employers to
comply with section 1310(a) of the Public Health Service Act [section 300e–9 of this title] after the date of the
enactment of this Act [Oct. 8, 1976].
‘‘(8) The amendment made by section 111 [amending
section 300e–11 of this title] shall apply with respect to
determinations of the Secretary of Health, Education,
and Welfare described in section 1312(a) of the Public
Health Service Act [section 300e–11(a) of this title] and
made after the date of the enactment of this Act [Oct.
8, 1976].’’
SHORT TITLE OF 1978 AMENDMENT
For short title of Pub. L. 95–559 as the ‘‘Health Maintenance Organization Amendments of 1978’’, see section
1 of Pub. L. 95–559, set out as a note under section 201
of this title.
SHORT TITLE OF 1976 AMENDMENT
For short title of Pub. L. 94–460 which substantially
amended this subchapter, as the ‘‘Health Maintenance
Organization Amendments of 1976’’, see section 1(a) of
Pub. L. 94–460, set out as a note under section 201 of
this title.
SHORT TITLE
For short title of Pub. L. 93–222, which enacted this
subchapter, as the ‘‘Health Maintenance Organization
Act of 1973’’, see section 1 of Pub. L. 93–222, set out as

Page 946

a Short Title of 1973 Amendments note under section
201 of this title.
QUALIFICATION OF HEALTH MAINTENANCE ORGANIZATION
CONTINGENT UPON CONTROLLING ORGANIZATION’S ASSUMPTION OF FINANCIAL OBLIGATIONS AND MEETING
OTHER REQUIREMENTS
Section 5(a)(3) of Pub. L. 100–517 provided that: ‘‘During the period prior to the effective date of regulations
issued under section 1301(c) of the Public Health Service Act [subsec. (c) of this section] (as amended by
paragraph (2)), the Secretary of Health and Human
Services shall consider the application for qualification
under section 1301(c)(1)(A) of such Act of a health maintenance organization—
‘‘(A) which is owned or controlled by another organization, and
‘‘(B) which requests that the resources of the other
organization be considered in determining its qualification under such section,
if the Secretary receives satisfactory assurances from
the other organization that it will assume the financial
obligations of the health maintenance organization and
if the Secretary determines that the other organization
meets such other requirements as the Secretary determines are necessary.’’
STUDY ON HEALTH MAINTENANCE ORGANIZATION
PROGRAM
Pub. L. 99–660, title VIII, § 813, Nov. 14, 1986, 100 Stat.
3801, which provided for a study to assess the operation
and impact of the provisions of this subchapter and a
report to Congress on the findings and conclusions of
such study within 18 months after Nov. 14, 1986, was repealed by Pub. L. 102–531, title III, § 311(a), Oct. 27, 1992,
106 Stat. 3503, effective as if such repeal was enacted on
Nov. 14, 1986.
HEALTH CARE QUALITY ASSURANCE PROGRAMS STUDY
Section 4 of Pub. L. 93–222 required Secretary of
Health, Education, and Welfare to contract for conduct
of a study of health care quality assurance programs
and submit a final report to specific committees of
Congress by Jan. 31, 1976.

§ 300e–1. Definitions
For purposes of this subchapter:
(1) The term ‘‘basic health services’’ means—
(A) physician services (including consultant
and referral services by a physician);
(B) inpatient and outpatient hospital services;
(C) medically necessary emergency health
services;
(D) short-term (not to exceed twenty visits),
outpatient evaluative and crisis intervention
mental health services;
(E) medical treatment and referral services
(including referral services to appropriate ancillary services) for the abuse of or addiction
to alcohol and drugs;
(F) diagnostic laboratory and diagnostic and
therapeutic radiologic services;
(G) home health services; and
(H) preventive health services (including (i)
immunizations, (ii) well-child care from birth,
(iii) periodic health evaluations for adults, (iv)
voluntary family planning services, (v) infertility services, and (vi) children’s eye and ear
examinations conducted to determine the need
for vision and hearing correction).
Such term does not include a health service
which the Secretary, upon application of a
health maintenance organization, determines is

Page 947

TITLE 42—THE PUBLIC HEALTH AND WELFARE

unusual and infrequently provided and not necessary for the protection of individual health.
The Secretary shall publish in the Federal Register each determination made by him under the
preceding sentence. If a service of a physician
described in the preceding sentence may also be
provided under applicable State law by a dentist, optometrist, podiatrist, psychologist, or
other health care personnel, a health maintenance organization may provide such service
through a dentist, optometrist, podiatrist, psychologist, or other health care personnel (as the
case may be) licensed to provide such service.
Such term includes a health service directly associated with an organ transplant only if such
organ transplant was required to be included in
basic health services on April 15, 1985. For purposes of this paragraph, the term ‘‘home health
services’’ means health services provided at a
member’s home by health care personnel, as prescribed or directed by the responsible physician
or other authority designated by the health
maintenance organization.
(2) The term ‘‘supplemental health services’’
means any health service which is not included
as a basic health service under paragraph (1) of
this section. If a health service provided by a
physician may also be provided under applicable
State law by a dentist, optometrist, podiatrist,
psychologist, or other health care personnel, a
health maintenance organization may provide
such service through an optometrist, dentist,
podiatrist, psychologist, or other health care
personnel (as the case may be) licensed to provide such service.
(3) The term ‘‘member’’ when used in connection with a health maintenance organization
means an individual who has entered into a contractual arrangement, or on whose behalf a contractual arrangement has been entered into,
with the organization under which the organization assumes the responsibility for the provision
to such individual of basic health services and of
such supplemental health services as may be
contracted for.
(4) The term ‘‘medical group’’ means a partnership, association, or other group—
(A) which is composed of health professionals licensed to practice medicine or osteopathy and of such other licensed health professionals (including dentists, optometrists,
podiatrists, and psychologists) as are necessary for the provision of health services for
which the group is responsible;
(B) a majority of the members of which are
licensed to practice medicine or osteopathy;
and
(C) the members of which (i) as their principal professional activity engage in the coordinated practice of their profession and as a
group responsibility have substantial responsibility for the delivery of health services to
members of a health maintenance organization, except that this clause does not apply before the end of the forty-eight month period
beginning after the month in which the health
maintenance oranization 1 becomes a qualified
health maintenance organization as defined in
section 300e–9(d) 2 of this title, or as authorized
1 So

in original. Probably should be ‘‘organization’’.
References in Text note below.

2 See

§ 300e–1

by the Secretary in accordance with regulations that take into consideration the unusual
circumstances of the group; (ii) pool their income from practice as members of the group
and distribute it among themselves according
to a prearranged salary or drawing account or
other similar plan unrelated to the provision
of specific health services; (iii) share medical
and other records and substantial portions of
major equipment and of professional, technical, and administrative staff; (iv) arrange for
and encourage continuing education in the
field of clinical medicine and related areas for
the members of the group; and (v) establish an
arrangement whereby a member’s enrollment
status is not known to the health professional
who provides health services to the member.
(5) The term ‘‘individual practice association’’
means a partnership, corporation, association,
or other legal entity which has entered into a
services arrangement (or arrangements) with
persons who are licensed to practice medicine,
osteopathy, dentistry, podiatry, optometry, psychology, or other health profession in a State
and a majority of whom are licensed to practice
medicine or osteopathy. Such an arrangement
shall provide—
(A) that such persons shall provide their professional services in accordance with a compensation arrangement established by the entity; and
(B) to the extent feasible, for the sharing by
such persons of medical and other records,
equipment, and professional, technical, and
administrative staff.
(6) The term ‘‘health systems agency’’ means
an entity which is designated in accordance
with section 300l–4 of this title.
(7) The term ‘‘medically underserved population’’ means the population of an urban or
rural area designated by the Secretary as an
area with a shortage of personal health services
or a population group designated by the Secretary as having a shortage of such services.
Such a designation may be made by the Secretary only after consideration of the comments
(if any) of (A) each State health planning and
development agency which covers (in whole or
in part) such urban or rural area or the area in
which such population group resides, and (B)
each health systems agency designated for a
health service area which covers (in whole or in
part) such urban or rural area or the area in
which such population group resides.
(8)(A) The term ‘‘community rating system’’
means the systems, described in subparagraphs
(B) and (C), of fixing rates of payments for
health services. A health maintenance organization may fix its rates of payments under the system described in subparagraph (B) or (C) or
under both such systems, but a health maintenance organization may use only one such system for fixing its rates of payments for any one
group.
(B) A system of fixing rates of payment for
health services may provide that the rates shall
be fixed on a per-person or per-family basis and
may authorize the rates to vary with the number of persons in a family, but, except as authorized in subparagraph (D), such rates must be

§ 300e–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

equivalent for all individuals and for all families
of similar composition.
(C) A system of fixing rates of payment for
health services may provide that the rates shall
be fixed for individuals and families by groups.
Except as authorized in subparagraph (D), such
rates must be equivalent for all individuals in
the same group and for all families of similar
composition in the same group. If a health
maintenance organization is to fix rates of payment for individuals and families by groups, it
shall—
(i)(I) classify all of the members of the organization into classes based on factors which
the health maintenance organization determines predict the differences in the use of
health services by the individuals or families
in each class and which have not been disapproved by the Secretary,
(II) determine its revenue requirements for
providing services to the members of each
class established under subclause (I), and
(III) fix the rates of payments for the individuals and families of a group on the basis of
a composite of the organization’s revenue requirements determined under subclause (II)
for providing services to them as members of
the classes established under subclause (I), or
(ii) fix the rates of payments for the individuals and families of a group on the basis of the
organization’s revenue requirements for providing services to the group, except that the
rates of payments for the individuals and families of a group of less than 100 persons may
not be fixed at rates greater than 110 percent
of the rate that would be fixed for such individuals and families under subparagraph (B) or
clause (i) of this subparagraph.
The Secretary shall review the factors used by
each health maintenance organization to establish classes under clause (i). If the Secretary determines that any such factor may not reasonably be used to predict the use of the health
services by individuals and families, the Secretary shall disapprove such factor for such purpose. If a health maintenance organization is to
fix rates of payment for a group under clause
(ii), it shall, upon request of the entity with
which it contracts to provide services to such
group, disclose to that entity the method and
data used in calculating the rates of payment.
(D) The following differentials in rates of payments may be established under the systems described in subparagraphs (B) and (C):
(i) Nominal differentials in such rates may
be established to reflect differences in marketing costs and the different administrative
costs of collecting payments from the following categories of members:
(I) Individual members (including their
families).
(II) Small groups of members (as determined under regulations of the Secretary).
(III) Large groups of members (as determined under regulations of the Secretary).
(ii) Nominal differentials in such rates may
be established to reflect the compositing of
the rates of payment in a systematic manner
to accommodate group purchasing practices of
the various employers.

Page 948

(iii) Differentials in such rates may be established for members enrolled in a health maintenance organization pursuant to a contract
with a governmental authority under section
1079 or 1086 of title 10 or under any other governmental program (other than the health
benefits program authorized by chapter 89 of
title 5) or any health benefits program for employees of States, political subdivision of
States, and other public entities.
(9) The term ‘‘non-metropolitan area’’ means
an area no part of which is within an area designated as a standard metropolitan statistical
area by the Office of Management and Budget
and which does not contain a city whose population exceeds fifty thousand individuals.
(July 1, 1944, ch. 373, title XIII, § 1302, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 917;
amended Pub. L. 94–460, title I, §§ 102(b), 104,
105(b), (c), 106, 117(b)(1), (2), Oct. 8, 1976, 90 Stat.
1946–1948, 1955; Pub. L. 95–559, § 11(e), Nov. 1, 1978,
92 Stat. 2139; Pub. L. 97–35, title IX, § 942(f)–(j),
Aug. 13, 1981, 95 Stat. 574, 575; Pub. L. 97–414,
§ 9(c), Jan. 4, 1983, 96 Stat. 2064; Pub. L. 99–660,
title VIII, §§ 812(a), 814, Nov. 14, 1986, 100 Stat.
3801, 3802; Pub. L. 100–517, § 6(b), Oct. 24, 1988, 102
Stat. 2579.)
REFERENCES IN TEXT
Section 300e–9(d) of this title, referred to in par.
(4)(C), was redesignated section 300e–9(c) of this title by
Pub. L. 100–517, § 7(b), Oct. 24, 1988, 102 Stat. 2580.
AMENDMENTS
1988—Par. (8)(C). Pub. L. 100–517, § 6(b)(1), amended
third sentence generally. Prior to amendment, third
sentence read as follows: ‘‘If a health maintenance organization is to fix rates of payment for individuals and
families by groups, it shall—
‘‘(i) classify all of the members of the organization
into classes based on factors which the health maintenance organization determines predict the differences in the use of health services by the individuals or families in each class and which have not been
disapproved by the Secretary,
‘‘(ii) determine its revenue requirements for providing services to the members of each class established
under clause (i), and
‘‘(iii) fix the rates of payment for the individuals
and families of a group on the basis of a composite of
the organization’s revenue requirements determined
under clause (ii) for providing services to them as
members of the classes established under clause (i).’’
Pub. L. 100–517, § 6(b)(2), inserted at end ‘‘If a health
maintenance organization is to fix rates of payment for
a group under clause (ii), it shall, upon request of the
entity with which it contracts to provide services to
such group, disclose to that entity the method and data
used in calculating the rates of payment.’’
1986—Par. (1). Pub. L. 99–660, § 814(a), inserted ‘‘psychologist,’’ in two places in fourth sentence.
Pub. L. 99–660, § 812(a), (b)(1), temporarily inserted
‘‘Such term includes a health service directly associated with an organ transplant only if such organ transplant was required to be included in basic health services on April 15, 1985.’’ in closing provisions. See Effective and Termination Dates of 1986 Amendment note
below.
Par. (2). Pub. L. 99–660, § 814(a), inserted ‘‘psychologist,’’ in two places.
Par. (4)(A). Pub. L. 99–660, § 814(b), substituted ‘‘podiatrists, and psychologists’’ for ‘‘and podiatrists’’.
Par. (5). Pub. L. 99–660, § 814(c), inserted ‘‘psychology,’’.
1983—Par. (5)(B). Pub. L. 97–414 amended directory
language of Pub. L. 97–35, § 942(i), to correct a typo-

Page 949

TITLE 42—THE PUBLIC HEALTH AND WELFARE

graphical error, and did not involve any change in text.
See 1981 Amendment note below.
1981—Par. (1). Pub. L. 97–35, § 942(f), struck out provisions authorizing health maintenance organizations to
maintain, etc., drug use profiles of members.
Par. (2). Pub. L. 97–35, § 942(g), substituted provisions
to include services not included under par. (1), for provisions enumerating specific services, substituted
‘‘health service provided by a physician’’ for ‘‘service of
a physician described in the preceding sentence’’, and
struck out provisions authorizing health maintenance
organizations to maintain, etc., drug use profiles of
members.
Par. (4)(C)(i). Pub. L. 97–35, § 942(h), inserted provisions relating to applicability to qualified organizations.
Par. (5)(B). Pub. L. 97–35, § 942(i), as amended by Pub.
L. 97–414, § 9(c), struck out ‘‘(i)’’ after ‘‘feasible’’, and
struck out cl. (ii) which related to continuing education.
Par. (8). Pub. L. 97–35, § 942(j), reorganized and restructured provisions and, among many changes, provided for determinations based upon subpars. (B) and
(C), and set out determinations respecting differentials
contained in former subpars. (B) and (C) as subpar. (D).
1978—Par. (1). Pub. L. 95–559 inserted provisions to exclude a health service which the Secretary, upon application of a health maintenance organization, determines is unusual and infrequently provided and not
necessary for protection of individual health and that
the Secretary publish in Federal Register each determination made by him under preceding sentence.
1976—Par. (1). Pub. L. 94–460, § 104(a), substituted reference to immunization, well-child care from birth,
periodic health evaluations for adults, and children’s
ear examinations conducted to determine need for
hearing correction for reference to preventive dental
care for children in (H) and, in the provisions following
subpar. (H), inserted reference to ‘‘other health care
personnel’’.
Par. (2). Pub. L. 94–460, § 104(b), substituted ‘‘basic
health service’’ for ‘‘basic health service under paragraph (1)(A) or (1)(H)’’ in subpars. (B) and (C), added
subpar. (G), and inserted reference to ‘‘other health
care personnel’’ in provisions following subpar. (G).
Par. (4)(C). Pub. L. 94–460, §§ 102(b)(1), 106, substituted
‘‘as their principal professional activity engage in the
coordinated practice of their profession and as a group
responsibility have substantial responsibility for the
delivery of health services to members of a health
maintenance organization’’ for ‘‘as their principal professional activity and as a group responsibility engage
in the coordinated practice of their profession for a
health maintenance organization’’ in cl. (i), substituted
‘‘similar plan unrelated to the provision of specific
health services’’ for ‘‘plan’’ in cl. (ii), struck out former
cl. (iv) which covered the utilization of additional professional personnel, allied health professions personnel,
and other health personnel as are available and appropriate for the effective and efficient delivery of the
services of the members of the group, redesignated
former cl. (v) as (iv), and added cl. (v).
Par. (5)(B). Pub. L. 94–460, § 102(b)(2), struck out
former cl. (i) which covered the utilization of additional professional personnel, allied health professions
personnel, and other personnel as are available and appropriate for the effective and efficient delivery of the
services of the persons who are parties to the arrangement, and redesignated former cls. (ii) and (iii) as (i)
and (ii), respectively.
Par. (6). Pub. L. 94–460, § 117(b)(1), substituted provisions defining ‘‘health systems agency’’ for provisions
defining ‘‘section 314(a) State health planning agency’’
and ‘‘section 314(b) areawide health planning agency’’.
Par. (7). Pub. L. 94–460, § 117(b)(2), substituted ‘‘State
health planning and development agency which’’ for
‘‘section 314(a) State health planning agency whose section 314(a) plan’’ and ‘‘health systems agency designated for a health service area which’’ for ‘‘section
314(b) areawide health planning agency whose section
314(b) plan’’.

§ 300e–1

Par. (8). Pub. L. 94–460, § 105(b), (c), substituted ‘‘to reflect differences in marketing costs and the different
administrative costs’’ for ‘‘to reflect the different administrative costs’’ in subpar. (A) preceding cl. (i),
added subpar. (B), and redesignated former subpar. (B)
as (C).
EFFECTIVE AND TERMINATION DATES OF 1986
AMENDMENT
Section 812(b)(1) of Pub. L. 99–660, which provided
that amendment by subsection (a), amending this section, was to take effect on Oct. 1, 1985, and was to cease
to be in effect on Apr. 1, 1988, was repealed by Pub. L.
100–517, § 6(a), Oct. 24, 1988, 102 Stat. 2579.
Section 815 of title VIII of Pub. L. 99–660 provided
that:
‘‘(a) Except as provided in subsection (b) and section
812(b) [enacting provisions set out as notes above and
below], this title and the amendments made by this
title [amending this section and sections 300e–4, 300e–5
to 300e–10, 300e–16, and 300e–17 of this title, repealing
sections 300e–2, 300e–3, and 300e–4a of this title, and enacting provisions set out as notes under this section
and sections 201, 300e, 300e–4, and 300e–5 of this title]
shall take effect on October 1, 1985.
‘‘(b) Section 813 [enacting provisions set out as a note
under section 300e of this title] shall take effect on the
date of enactment of this Act [Nov. 14, 1986].’’
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
except that amendment of pars. (1) and (2) of this section by section 104 of Pub. L. 94–460 and the amendment
of pars. (4)(C) and (5)(B) of this section by sections 102
and 106 of Pub. L. 94–460 applicable with respect to
grants, contracts, loans, and loan guarantees made
under sections 300e–2, 300e–3, and 300e–4 of this title for
fiscal years beginning after Sept. 30, 1976, applicable
with respect to health benefit plans offered under section 300e–9 of this title after Sept. 30, 1976, and effective
for purposes of section 300e–11 of this title on Oct. 1,
1976, see section 118 of Pub. L. 94–460, set out as a note
under section 300e of this title.
CONSTRUCTION
Section 816 of title VIII of Pub. L. 99–660 provided
that: ‘‘The provisions of this title and of the amendments made by this title [amending this section and
sections 300e–4, 300e–5 to 300e–10, 300e–16, and 300e–17 of
this title, repealing sections 300e–2, 300e–3, and 300e–4a
of this title, and enacting provisions set out as notes
under this section and sections 201, 300e, 300e–4, and
300e–5 of this title] do not authorize the appropriation
of any funds for fiscal year 1986.’’
BASIC HEALTH SERVICE STATUS OF CERTAIN ORGAN
TRANSPLANT SERVICES AFTER APRIL 1, 1988
Section 812(b)(2) of Pub. L. 99–660, which provided
that after Apr. 1, 1988, for purposes of this subchapter,
no health service directly associated with an organ
transplant was to be considered to be a basic health
service if such service would otherwise have been added
as a basic health service between Apr. 15, 1985, and Apr.
1, 1988, was repealed by Pub. L. 100–517, § 6(a), Oct. 24,
1988, 102 Stat. 2579.
REPORTS RESPECTING MEDICALLY UNDERSERVED AREAS
AND POPULATION GROUPS AND NON-METROPOLITAN
AREAS
Section 5 of Pub. L. 93–222 directed Secretary of
Health, Education, and Welfare to report to Congress
the criteria used in the designation of medically underserved areas and population groups for purposes of par.
(7) of this section by Dec. 29, 1973, and report to Congress the areas and population groups designated under
par. (7) of this section, the comments of State and areawide health planning agencies, and areas which meet
the definitional standards of par. (9) of this section for
non-metropolitan areas by Dec. 29, 1974, and that the

§§ 300e–2, 300e–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Office of Management and Budget may review such reports before their submission to Congress.

§§ 300e–2, 300e–3. Repealed. Pub. L. 99–660, title
VIII, § 803(a), Nov. 14, 1986, 100 Stat. 3799
Section 300e–2, act July 1, 1944, ch. 373, title XIII,
§ 1303, as added Dec. 29, 1973, Pub. L. 93–222, § 2, 87 Stat.
920; amended Oct. 8, 1976, Pub. L. 94–460, title I, §§ 107(a),
109(d)(1), 117(b)(3), 90 Stat. 1948, 1950, 1955; Aug. 13, 1981,
Pub. L. 97–35, title IX, § 947(a), 95 Stat. 577, provided for
grants and contracts for feasibility surveys.
Section 300e–3, act July 1, 1944, ch. 373, title XIII,
§ 1304, as added Dec. 29, 1973, Pub. L. 93–222, § 2, 87 Stat.
921; amended Apr. 21, 1976, Pub. L. 94–273, § 40, 90 Stat.
381; Oct. 8, 1976, Pub. L. 94–460, title I, §§ 107(b), 108(a),
(b), (d)(1), 109(d)(2), (3), (e), 113(a), 117(b)(4), 90 Stat.
1948–1950, 1953, 1955; Nov. 1, 1978, Pub. L. 95–559, §§ 2(a),
3(a)–(c), 6, 92 Stat. 2131, 2134; July 10, 1979, Pub. L. 96–32,
§ 2(a), 93 Stat. 82; Aug. 13, 1981, Pub. L. 97–35, title IX,
§§ 941(c), 947(b), 95 Stat. 573, 577, provided for grants,
contracts, and loan guarantees for planning and for initial development costs.
EFFECTIVE DATE OF REPEAL
Repeal not applicable to any grant made or contract
entered into under this subchapter before Oct. 1, 1985,
see section 803(c) of Pub. L. 99–660, set out as an Effective Date of 1986 Amendment note under section 300e–5
of this title.
Repeal effective Oct. 1, 1985, see section 815(a) of Pub.
L. 99–660, set out as an Effective and Termination Dates
of 1986 Amendment note under section 300e–1 of this
title.

§ 300e–4. Loans and loan guarantees for initial
operation costs
(a) Authority
The Secretary may—
(1) make loans to public or private health
maintenance organizations to assist them in
meeting the amount by which their costs of
operation during a period not to exceed the
first sixty months of their operation exceed
their revenues in that period;
(2) make loans to public or private health
maintenance organizations to assist them in
meeting the amount by which their costs of
operation, which the Secretary determines are
attributable to significant expansion in their
membership or area served and which are incurred during a period not to exceed the first
sixty months of their operation after such expansion, exceed their revenues in that period
which the Secretary determines are attributable to such expansion; and
(3) guarantee to non-Federal lenders payment of the principal of and the interest on
loans made to private health maintenance organizations for the amounts referred to in
paragraphs (1) and (2).
No loan or loan guarantee may be made under
this subsection for the costs of operation of a
health maintenance organization unless the Secretary determines that the organization has
made all reasonable attempts to meet such
costs, and unless the Secretary has made a grant
or loan to, entered into a contract with, or guaranteed a loan for, the organization in fiscal year
1981, 1982, 1983, 1984, or 1985 under this section or
section 300e–3(b) 1 of this title (as in effect before
October 1, 1985).
1 See

References in Text note below.

Page 950

(b) Limitations
(1) Except as provided in paragraph (2), the aggregate amount of principal of loans made or
guaranteed, or both, under subsection (a) of this
section for a health maintenance organization
may not exceed $7,000,000. In any twelve-month
period the amount disbursed to a health maintenance organization under this section (either directly by the Secretary, by an escrow agent
under the terms of an escrow agreement, or by
a lender under a guaranteed loan) may not exceed $3,000,000.
(2) The cumulative total of the principal of the
loans outstanding at any time which have been
directly made, or with respect to which guarantees have been issued, under subsection (a) of
this section may not exceed such limitations as
may be specified in appropriation Acts.
(c) Source of loan funds
Loans under this section shall be made from
the fund established under section 300e–7(e) of
this title.
(d) Time limit on loans and loan guarantees
No loan may be made or guaranteed under this
section after September 30, 1986.
(e) Repealed. Pub. L. 97–35, title IX, § 947(c), Aug.
13, 1981, 95 Stat. 577
(f) Medically underserved populations
In considering applications for loan guarantees under this section, the Secretary shall give
special consideration to applications for health
maintenance organizations which will serve
medically underserved populations.
(July 1, 1944, ch. 373, title XIII, § 1305, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 924;
amended Pub. L. 93–641, § 8, Jan. 4, 1975, 88 Stat.
2276; Pub. L. 94–273, § 2(21), Apr. 21, 1976, 90 Stat.
376; Pub. L. 94–460, title I, §§ 107(c), 108(c), (d)(2),
109(a)(1), (2), 113(b), Oct. 8, 1976, 90 Stat. 1949,
1953; Pub. L. 95–559, §§ 2(b), 4(a), (b), Nov. 1, 1978,
92 Stat. 2131, 2132; Pub. L. 96–32, § 2(d), July 10,
1979, 93 Stat. 82; Pub. L. 97–35, title IX,
§§ 943(a)–(c), 947(c), Aug. 13, 1981, 95 Stat. 576, 577;
Pub. L. 99–660, title VIII, § 804(a), Nov. 14, 1986,
100 Stat. 3800.)
REFERENCES IN TEXT
Section 300e–3(b) of this title, referred to in subsec.
(a), was repealed by Pub. L. 99–660, title VIII, § 803(a),
Nov. 14, 1986, 100 Stat. 3799.
AMENDMENTS
1986—Subsec. (a). Pub. L. 99–660 inserted ‘‘, and unless
the Secretary has made a grant or loan to, entered into
a contract with, or guaranteed a loan for, the organization in fiscal year 1981, 1982, 1983, 1984, or 1985 under
this section or section 300e–3(b) of this title (as in effect
before October 1, 1985)’’ at end of last sentence.
1981—Subsec. (a). Pub. L. 97–35, § 943(a), in pars. (1)
and (2) struck out ‘‘nonprofit’’ before ‘‘private’’, and in
par. (3) substituted provisions respecting guarantees for
private health maintenance organizations, for guarantees for nonprofit private health maintenance organizations.
Subsec. (b)(1). Pub. L. 97–35, § 943(b), generally revised
limitations and, among many changes, increased
amounts subject to coverage, and struck out requirements respecting Congressional oversight for increases
in amounts.
Subsec. (d). Pub. L. 97–35, § 943(c), substituted ‘‘1986’’
for ‘‘1981’’.

Page 951

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (e). Pub. L. 97–35, § 947(c), struck out subsec.
(e) which related to projects in nonmetropolitan areas.
1979—Subsec. (b)(1). Pub. L. 96–32 substituted
‘‘$4,500,000’’ for ‘‘$4,000,000’’ in two places.
1978—Subsec. (a). Pub. L. 95–559, § 4(b)(1), substituted
‘‘costs of operation’’ for ‘‘operating costs’’ wherever appearing.
Subsec. (b)(1). Pub. L. 95–559, § 4(a), (b)(2), inserted
‘‘(or $4,000,000 if the Secretary makes a written determination that such loans or loan guarantees are necessary to preserve the fiscally sound operation of the
health maintenance organization and to protect
against the risk of insolvency of the health maintenance organization and, within 30 days of the making
of such loans or loan guarantees, furnishes the Committee on Human Resources of the Senate and the
Committee on Interstate and Foreign Commerce of the
House of Representatives with written notification of
the making of the loans or loan guarantees and a copy
of the written determination made with respect to the
loans or loan guarantees and the reasons for the determination) through September 30, 1979, and $4,000,000
thereafter’’ after ‘‘$2,500,000’’ and ‘‘(or $2,000,000 if the
Secretary makes a written determination that such
disbursements are necessary to preserve the fiscally
sound operation of the health maintenance organization and protect against the risk of insolvency of the
health maintenance organization and, within 30 days of
such disbursement, furnishes the Committee on Human
Resources of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives with written notification of the making of the
disbursement and a copy of the written determination
made with respect to it and the reasons for the determination) through September 30, 1979, and $2,000,000
thereafter’’ after ‘‘$1,000,000’’ and substituted ‘‘any
twelve-month period’’ for ‘‘any fiscal year’’.
Subsec. (d). Pub. L. 95–559, § 2(b), substituted ‘‘September 30, 1981’’ for ‘‘September 30, 1980’’.
1976—Subsec. (a)(1), (2). Pub. L. 94–460, §§ 107(c),
109(a)(1), substituted ‘‘during a period not to exceed the
first sixty months’’ for ‘‘in the period of the first thirty-six months’’.
Subsec. (a)(3). Pub. L. 94–460, § 108(c), substituted reference to loans made to nonprofit private health maintenance organizations for the amounts referred to in
paragraph (1) or (2), or to other private health maintenance organizations for such amounts but only if the
health maintenance organization will serve a medically
underserved population for reference to loans made to
any private health maintenance organization (other
than a private nonprofit health maintenance organization) for the amounts referred to in paragraph (1) or (2),
but only if such health maintenance organization will
serve a medically underserved population.
Subsec. (b)(1). Pub. L. 94–460, § 109(a)(2), substituted
‘‘In any fiscal year the amount disbursed to a health
maintenance organization under this section (either directly by the Secretary or by an escrow agent under
the terms of an escrow agreement or by a lender under
a loan guaranteed under this section) may not exceed
$1,000,000’’ for ‘‘In any fiscal year, the amount disbursed
under a loan or loans made or guaranteed under this
section for a health maintenance organization may not
exceed $1,000,000,000’’.
Subsec. (d). Pub. L. 94–460, § 113(b), substituted ‘‘No
loan may be made or guaranteed under this section
after September 30, 1980’’ for ‘‘A loan or loan guarantee
may be made under this section through the fiscal year
ending June 30, 1978’’.
Pub. L. 94–273 substituted ‘‘September’’ for ‘‘June’’.
Subsec. (f). Pub. L. 94–460, § 108(d)(2), added subsec. (f).
1975—Subsec. (b)(1). Pub. L. 93–641 substituted provisions that amount disbursed under a loan or loans
made or guaranteed under this section for a health
maintenance organization may not exceed $1,000,000,000
for provisions that principal amount of any loan made
or guaranteed under subsec. (a) of this section for a
health maintenance organization may not exceed
$1,000,000.

§ 300e–5

EFFECTIVE DATE OF 1986 AMENDMENT
Section 804(b) of Pub. L. 99–660 provided that: ‘‘The
amendment made by subsection (a) [amending this section] does not apply to any loan or loan guarantee for
the initial costs of operation of a health maintenance
organization made under title XIII of the Public Health
Service Act [this subchapter] before October 1, 1985.’’
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Section 4(d) of Pub. L. 95–559 provided that: ‘‘The
amendments made by this section [amending this section and section 300e–7 of this title] shall only be effective for fiscal years beginning on or after October 1,
1978.’’
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
except that the amendment of subsec. (a)(1), (2) of this
section by section 107(c) of Pub. L. 94–460 applicable
with respect to grants, contracts, loans, and loan guarantees made under this section and sections 300e–2 and
300e–3 of this title for fiscal years beginning after Sept.
30, 1976, and except that the amendment of subsec.
(a)(1), (2) of this section by section 109(a)(1) of Pub. L.
94–460 applicable with respect to loan guarantees made
under this section after Sept. 30, 1976, see section 118 of
Pub. L. 94–460, set out as a note under section 300e of
this title.

§ 300e–4a. Repealed. Pub. L. 99–660, title VIII,
§ 805(a), Nov. 14, 1986, 100 Stat. 3800
Section, act July 1, 1944, ch. 373, title XIII, § 1305A, as
added Nov. 1, 1978, Pub. L. 95–559, § 5(a), 92 Stat. 2133;
amended July 10, 1979, Pub. L. 96–32, § 2(e), 93 Stat. 82;
Aug. 13, 1981, Pub. L. 97–35, title IX, § 944, 95 Stat. 576,
related to loans and loan guarantees for acquisition
and construction of ambulatory health care facilities.
EFFECTIVE DATE OF REPEAL
Repeal not applicable to any loan or loan guarantee
made under this section before Oct. 1, 1985, see section
805(c) of Pub. L. 99–660, set out as an Effective Date of
1986 Amendment note under section 300e–5 of this title.
Repeal effective Oct. 1, 1985, see section 815(a) of Pub.
L. 99–660, set out as an Effective and Termination Dates
of 1986 Amendment note under section 300e–1 of this
title.

§ 300e–5. Application requirements
(a) Submission to and approval by Secretary required for making loans and loan guarantees
No loan or loan guarantee may be made under
this subchapter unless an application therefor
has been submitted to, and approved by, the
Secretary.
(b) Application contents
The Secretary may not approve an application
for a loan or loan guarantee under this subchapter unless—
(1) such application meets the requirements
of section 300e–7 of this title;
(2) in the case of an application for assistance under section 300e–4 of this title, he determines that the applicant making the application would not be able to complete the
project or undertaking for which the application is submitted without the assistance applied for;
(3) the application contains satisfactory
specification of the existing or anticipated (A)

§ 300e–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

population group or groups to be served by the
proposed or existing health maintenance organization described in the application, (B)
membership of such organization, (C) methods,
terms, and periods of the enrollment of members of such organization, (D) estimated costs
per member of the health and educational
services to be provided by such organization
and the nature of such costs, (E) sources of
professional services for such organization,
and organizational arrangements of such organization for providing health and educational
services, (F) organizational arrangements of
such organization for an ongoing quality assurance program in conformity with the requirements of section 300e(c) of this title, (G)
sources of prepayment and other forms of payment for the services to be provided by such
organization, (H) facilities, and additional capital investments and sources of financing
therefor, available to such organization to
provide the level and scope of services proposed, (I) administrative, managerial, and financial arrangements and capabilities of such
organization, (J) role for members in the planning and policymaking for such organization,
(K) grievance procedures for members of such
organization, and (L) evaluations of the support for and acceptance of such organization
by the population to be served, the sources of
operating support, and the professional groups
to be involved or affected thereby;
(4) contains or is supported by assurances
satisfactory to the Secretary that the applicant making the application will, in accordance with such criteria as the Secretary shall
by regulation prescribe, enroll, and maintain
an enrollment of the maximum number of
members that its available and potential resources (as determined under regulations of
the Secretary) will enable it to effectively
serve;
(5) in the case of an application made for a
project which previously received a grant, contract, loan, or loan guarantee under this subchapter, such application contains or is supported by assurances satisfactory to the Secretary that the applicant making the application has the financial capability to adequately
carry out the purposes of such project and has
developed and operated such project in accordance with the requirements of this subchapter
and with the plans contained in previous applications for such assistance;
(6) the application contains such assurances
as the Secretary may require respecting the
intent and the ability of the applicant to meet
the requirements of paragraphs (1) and (2) of
section 300e(b) of this title respecting the fixing of basic health services payments and supplemental health services payments under a
community rating system; and
(7) the application is submitted in such form
and manner, and contains such additional information, as the Secretary shall prescribe in
regulations.
An organization making multiple applications
for more than one loan or loan guarantee under
this subchapter, simultaneously or over the
course of time, shall not be required to submit
duplicate or redundant information but shall be

Page 952

required to update the specifications (required
by paragraph (3)) respecting the existing or proposed health maintenance organization in such
manner and with such frequency as the Secretary may by regulation prescribe. In determining, for purposes of paragraph (2), whether
an applicant would be able to complete a project
or undertaking without the assistance applied
for, the Secretary shall not consider any asset of
the applicant the obligation of which for such
undertaking or project would jeopardize the fiscal soundness of the applicant.
(c) Regulations
The Secretary shall by regulation establish
standards and procedures for health systems
agencies to follow in reviewing and commenting
on applications for loans and loan guarantees
under this subchapter.
(July 1, 1944, ch. 373, title XIII, § 1306, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 925;
amended Pub. L. 94–460, title I, §§ 105(a)(3),
117(b)(5), (6), Oct. 8, 1976, 90 Stat. 1948, 1955; Pub.
L. 95–559, § 12(b), (c), Nov. 1, 1978, 92 Stat. 2140;
Pub. L. 99–660, title VIII, §§ 803(b)(1), 805(b), 806,
Nov. 14, 1986, 100 Stat. 3799, 3800.)
AMENDMENTS
1986—Subsec. (a). Pub. L. 99–660, § 803(b)(1)(A), substituted ‘‘loan’’ for ‘‘grant, contract, loan,’’.
Subsec. (b). Pub. L. 99–660, § 803(b)(1)(A), substituted
‘‘loan’’ for ‘‘grant, contract, loan,’’ in introductory text
and in second sentence.
Subsec. (b)(1). Pub. L. 99–660, § 803(b)(1)(B), struck out
‘‘in the case of an application for assistance under section 300e–2 or 300e–3 of this title, such application
meets the application requirements of such section and
in the case of an application for a loan or loan guarantee,’’ before ‘‘such application’’.
Subsec. (b)(2). Pub. L. 99–660, § 805(b), struck out reference to section 300e–4a.
Pub. L. 99–660, § 803(b)(1)(C), struck out reference to
section 300e–3.
Subsec. (b)(5) to (8). Pub. L. 99–660, § 806, redesignated
pars. (6), (7), and (8) as (5), (6), and (7), respectively, and
struck out former par. (5) which read as follows: ‘‘each
health systems agency designated for a health service
area which covers (in whole or in part) the area to be
served by the health maintenance organization for
which such application is submitted;’’.
Subsec. (c). Pub. L. 99–660, § 803(b)(1)(D), substituted
‘‘loans’’ for ‘‘grants, contracts, loans,’’.
1978—Subsec. (b). Pub. L. 95–559 in par. (2) inserted
‘‘in the case of an application for assistance under section 300e–3, 300e–4, or 300e–4a of this title,’’ before ‘‘he
determines’’ and in provisions following par. (8) inserted provision that in determining, for purposes of
par. (2), whether an applicant would be able to complete a project or undertaking without the assistance
applied for, the Secretary not consider any asset of the
applicant the obligation of which for such undertaking
or project would jeopardize the fiscal soundness of the
applicant.
1976—Subsec. (b)(5). Pub. L. 94–460, § 117(b)(5), substituted ‘‘each health systems agency designated for a
health service area which covers (in whole or in part)
the area to be served by the health maintenance organization for which such application is submitted;’’ for
‘‘the section 314(b) areawide health planning agency
whose section 314(b) plan covers (in whole or in part)
the area to be served by the health maintenance organization for which such application is submitted, or if
there is no such agency, the section 314(a) State health
planning agency whose section 314(a) plan covers (in
whole or in part) such area, has, in accordance with
regulations of the Secretary under subsection (c) of

Page 953

TITLE 42—THE PUBLIC HEALTH AND WELFARE

this section, been provided an opportunity to review
the application and to submit to the Secretary for his
consideration its recommendations respecting approval
of the application or if under applicable State law such
an application may not be submitted without the approval of the section 314(b) areawide health planning
agency or the section 314(a) State health planning
agency, the required approval has been obtained;’’.
Subsec. (b)(7), (8). Pub. L. 94–460, § 105(a)(3), added par.
(7) and redesignated former par. (7) as (8).
Subsec. (c). Pub. L. 94–460, § 117(b)(6), substituted
‘‘health systems agencies’’ for ‘‘section 314(b) areawide
health planning agencies and section 314(a) State
health planning agencies’’.
EFFECTIVE DATE OF 1986 AMENDMENT
Section 803(c) of Pub. L. 99–660 provided that: ‘‘The
amendments made by this section [amending this section and sections 300e–6, 300e–8, and 300e–16 of this title
and repealing sections 300e–2 and 300e–3 of this title] do
not apply to any grant made or contract entered into
under title XIII of the Public Health Service Act [this
subchapter] before October 1, 1985.’’
Section 805(c) of Pub. L. 99–660 provided that: ‘‘The
amendments made by this section [amending this section and repealing section 300e–4a of this title] do not
apply to any loan or loan guarantee made under section
1305A of the Public Health Service Act [former section
300e–4a of this title] before October 1, 1985.’’
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
see section 118 of Pub. L. 94–460, set out as a note under
section 300e of this title.

§ 300e–6. Administration of assistance programs
(a) Recordkeeping; audit and examination
(1) Each recipient of a loan or loan guarantee
under this subchapter shall keep such records as
the Secretary shall prescribe, including records
which fully disclose the amount and disposition
by such recipient of the proceeds of the loan (directly made or guaranteed), the total cost of the
undertaking in connection with which the loan
was given or used, the amount of that portion of
the cost of the undertaking supplied by other
sources, and such other records as will facilitate
an effective audit.
(2) The Secretary, or any of his duly authorized representatives, shall have access for the
purpose of audit and examination to any books,
documents, papers, and records of the recipients
of a loan or loan guarantee under this subchapter which relate to such assistance.
(b) Report upon expiration of period
Upon expiration of the period for which a loan
or loan guarantee was provided an entity under
this subchapter, such entity shall make a full
and complete report to the Secretary in such
manner as he may by regulation prescribe. Each
such report shall contain, among such other
matters as the Secretary may by regulation require, descriptions of plans, developments, and
operations relating to the matters referred to in
section 300e–5(b)(3) of this title.

§ 300e–6

(c) Repealed. Pub. L. 99–660, title VIII, § 803(a),
Nov. 14, 1986, 100 Stat. 3799
(d) Other entities considered health maintenance
organizations
An entity which provides health services to a
defined population on a prepaid basis and which
has members who are entitled to insurance benefits under title XVIII of the Social Security
Act [42 U.S.C. 1395 et seq.] or to medical assistance under a State plan approved under title
XIX of such Act [42 U.S.C. 1396 et seq.] may be
considered as a health maintenance organization for purposes of receiving assistance under
this subchapter if—
(1) with respect to its members who are entitled to such insurance benefits or to such medical assistance it (A) provides health services
in accordance with section 300e(b) of this title,
except that (i) it does not furnish to those
members the health services (within the basic
health services) for which it may not be compensated under such title XVIII [42 U.S.C. 1395
et seq.] or such State plan, and (ii) it does not
fix the basic or supplemental health services
payment for such members under a community rating system, and (B) is organized and
operated in the manner prescribed by section
300e(c) of this title, except that it does not assume full financial risk on a prospective basis
for the provision to such members of basic or
supplemental health services with respect to
which it is not required under such title XVIII
or such State plan to assume such financial
risk; and
(2) with respect to its other members it provides health services in accordance with section 300e(b) of this title and is organized and
operated in the manner prescribed by section
300e(c) of this title.
An entity which provides health services to a
defined population on a prepaid basis and which
has members who are enrolled under the health
benefits program authorized by chapter 89 of
title 5, may be considered as a health maintenance organization for purposes of receiving assistance under this subchapter if with respect to
its other members it provides health services in
accordance with section 300e(b) of this title and
is organized and operated in the manner prescribed by section 300e(c) of this title.
(July 1, 1944, ch. 373, title XIII, § 1307, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 926;
amended Pub. L. 94–460, title I, §§ 109(b)(1), 112,
Oct. 8, 1976, 90 Stat. 1950, 1953; Pub. L. 97–35, title
IX, § 943(d), Aug. 13, 1981, 95 Stat. 576; Pub. L.
99–660, title VIII, § 803(a), (b)(2), Nov. 14, 1986, 100
Stat. 3799, 3800.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (d), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles
XVIII and XIX of the Social Security Act are classified
generally to subchapters XVIII (§ 1395 et seq.) and XIX
(§ 1396 et seq.), respectively, of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
AMENDMENTS
1986—Subsec. (a)(1). Pub. L. 99–660, § 803(b)(2), substituted ‘‘loan or loan guarantee’’ for ‘‘grant, contract,

§ 300e–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

loan, or loan guarantee’’, ‘‘proceeds of the loan’’ for
‘‘proceeds of the grant, contract, or loan’’, and ‘‘with
which the loan was given’’ for ‘‘with which such assistance was given’’.
Subsecs. (a)(2), (b). Pub. L. 99–660, § 803(b)(2)(A), substituted ‘‘loan or loan guarantee’’ for ‘‘grant, contract,
loan, or loan guarantee’’.
Subsec. (c). Pub. L. 99–660, § 803(a), struck out subsec.
(c) which read as follows: ‘‘If in any fiscal year the
funds appropriated under section 300e–8 of this title are
insufficient to fund all applications approved under
this subchapter for that fiscal year, the Secretary
shall, after applying the applicable priorities under sections 300e–2 and 300e–3 of this title, give priority to the
funding of applications for projects which the Secretary determines are the most likely to be economically viable.’’
1981—Subsec. (e). Pub. L. 97–35 struck out subsec. (e)
which related to limitation on cumulative total of loan
guarantees in any fiscal year.
1976—Subsec. (d). Pub. L. 94–460, § 112, inserted sentence at end setting conditions upon which an entity
providing health services to a defined population on a
prepaid basis may be considered as a health maintenance organization for purposes of receiving assistance
under this subchapter.
Subsec. (e). Pub. L. 94–460, § 109(b)(1), inserted ‘‘for a
private health maintenance organization (other than a
private nonprofit health maintenance organization)’’
after ‘‘may be made’’, and ‘‘for private health maintenance organizations (other than private nonprofit
health maintenance organizations)’’ after ‘‘guaranteed’’.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 not applicable to any
grant made or contract entered into under this subchapter before Oct. 1, 1985, see section 803(c) of Pub. L.
99–660, set out as a note under section 300e–5 of this
title.
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
see section 118 of Pub. L. 94–460, set out as a note under
section 300e of this title.

§ 300e–7. General provisions relating to loan
guarantees and loans
(a) Conditions
(1) The Secretary may not approve an application for a loan guarantee under this subchapter
unless he determines that (A) the terms, conditions, security (if any), and schedule and
amount of repayments with respect to the loan
are sufficient to protect the financial interests
of the United States and are otherwise reasonable, including a determination that the rate of
interest does not exceed such per centum per
annum on the principal obligation outstanding
as the Secretary determines to be reasonable,
taking into account the range of interest rates
prevailing in the private market for loans with
similar maturities, terms, conditions, and security and the risks assumed by the United States,
and (B) the loan would not be available on reasonable terms and conditions without the guarantee under this subchapter.
(2)(A) The United States shall be entitled to
recover from the applicant for a loan guarantee
under this subchapter the amount of any payment made pursuant to such guarantee, unless

Page 954

the Secretary for good cause waives such right
of recovery; and, upon making any such payment, the United States shall be subrogated to
all of the rights of the recipient of the payments
with respect to which the guarantee was made.
(B) To the extent permitted by subparagraph
(C), any terms and conditions applicable to a
loan guarantee under this subchapter (including
terms and conditions imposed under subparagraph (D)) may be modified by the Secretary to
the extent he determines it to be consistent
with the financial interest of the United States.
(C) Any loan guarantee made by the Secretary
under this subchapter shall be incontestable (i)
in the hands of an applicant on whose behalf
such guarantee is made unless the applicant engaged in fraud or misrepresentation in securing
such guarantee, and (ii) as to any person (or his
successor in interest) who makes or contracts to
make a loan to such applicant in reliance thereon unless such person (or his successor in interest) engaged in fraud or misrepresentation in
making or contracting to make such loan.
(D) Guarantees of loans under this subchapter
shall be subject to such further terms and conditions as the Secretary determines to be necessary to assure that the purposes of this subchapter will be achieved.
(b) Application requirements
(1) The Secretary may not approve an application for a loan under this subchapter unless—
(A) the Secretary is reasonably satisfied
that the applicant therefor will be able to
make payments of principal and interest
thereon when due, and
(B) the applicant provides the Secretary
with reasonable assurances that there will be
available to it such additional funds as may be
necessary to complete the project or undertaking with respect to which such loan is requested.
(2) Any loan made under this subchapter shall
(A) have such security, (B) have such maturity
date, (C) be repayable in such installments, (D)
on the date the loan is made, bear interest at a
rate comparable to the rate of interest prevailing on such date with respect to marketable obligations of the United States of comparable maturities, adjusted to provide for appropriate administrative charges, and (E) be subject to such
other terms and conditions (including provisions
for recovery in case of default) as the Secretary
determines to be necessary to carry out the purposes of this subchapter while adequately protecting the financial interests of the United
States. On the date disbursements are made
under a loan after the initial disbursement
under the loan, the Secretary may change the
rate of interest on the amount of the loan disbursed on that date to a rate which is comparable to the rate of interest prevailing on the
date the subsequent disbursement is made with
respect to marketable obligations of the United
States of comparable maturities, adjusted to
provide for appropriate administrative charges.
(3) The Secretary may, for good cause but with
due regard to the financial interests of the
United States, waive any right of recovery
which he has by reason of the failure of a borrower to make payments of principal of and in-

Page 955

TITLE 42—THE PUBLIC HEALTH AND WELFARE

terest on a loan made under this subchapter, except that if such loan is sold and guaranteed,
any such waiver shall have no effect upon the
Secretary’s guarantee of timely payment of
principal and interest.
(c) Sale of loans
(1) The Secretary may from time to time, but
with due regard to the financial interests of the
United States, sell loans made by him under this
subchapter.
(2) The Secretary may agree, prior to his sale
of any such loan, to guarantee to the purchaser
(and any successor in interest of the purchaser)
compliance by the borrower with the terms and
conditions of such loan. Any such agreement
shall contain such terms and conditions as the
Secretary considers necessary to protect the financial interests of the United States or as
otherwise appropriate. Any such agreement may
(A) provide that the Secretary shall act as agent
of any such purchaser for the purpose of collecting from the borrower to which such loan was
made and paying over to such purchaser, any
payments of principal and interest payable by
such organization under such loan; and (B) provide for the repurchase by the Secretary of any
such loan on such terms and conditions as may
be specified in the agreement. The full faith and
credit of the United States is pledged to the payment of all amounts which may be required to
be paid under any guarantee under this paragraph.
(3) After any loan under this subchapter to a
public health maintenance organization has
been sold and guaranteed under this subsection,
interest paid on such loan which is received by
the purchaser thereof (or his successor in interest) shall be included in the gross income of the
purchaser of the loan (or his successor in interest) for the purpose of chapter 1 of title 26.
(4) Amounts received by the Secretary as proceeds from the sale of loans under this subsection shall be deposited in the loan fund established under subsection (e) of this section.
(5) Any reference in this subchapter (other
than in this subsection and in subsection (d) of
this section) to a loan guarantee under this subchapter does not include a loan guarantee made
under this subsection.
(d) Loan guarantee fund
(1) There is established in the Treasury a loan
guarantee fund (hereinafter in this subsection
referred to as the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts as may be specified from
time to time in appropriation Acts, to enable
him to discharge his responsibilities under loan
guarantees issued by him under this subchapter
and to take the action authorized by subsection
(f) of this section. There are authorized to be appropriated from time to time such amounts as
may be necessary to provide the sums required
for the fund. To the extent authorized in appropriation Acts, there shall also be deposited in
the fund amounts received by the Secretary in
connection with loan guarantees under this subchapter and other property or assets derived by
him from his operations respecting such loan
guarantees, including any money derived from
the sale of assets.

§ 300e–7

(2) If at any time the sums in the funds are insufficient to enable the Secretary to discharge
his responsibilities under guarantees issued by
him before October 1, 1986, under this subchapter
and to take the action authorized by subsection
(f) of this section, he is authorized to issue to
the Secretary of the Treasury notes or other obligations in such forms and denominations,
bearing such maturities, and subject to such
terms and conditions, as may be prescribed by
the Secretary with the approval of the Secretary of the Treasury. Such notes or other obligations shall bear interest at a rate determined
by the Secretary of the Treasury, taking into
consideration the current average market yield
on outstanding marketable obligations of the
United States of comparable maturities during
the month preceding the issuance of the notes or
other obligations. The Secretary of the Treasury
shall purchase any notes and other obligations
issued under this paragraph and for that purpose
he may use as a public debt transaction the proceeds from the sale of any securities issued
under chapter 31 of title 31, and the purposes for
which the securities may be issued under that
chapter are extended to include any purchase of
such notes and obligations. The Secretary of the
Treasury may at any time sell any of the notes
or other obligations acquired by him under this
paragraph. All redemptions, purchases, and sales
by the Secretary of the Treasury of such notes
or other obligations shall be treated as public
debt transactions of the United States. Sums
borrowed under this paragraph shall be deposited in the fund and redemption of such notes
and obligations shall be made by the Secretary
from the fund.
(e) Loan fund
There is established in the Treasury a loan
fund (hereinafter in this subsection referred to
as the ‘‘fund’’) which shall be available to the
Secretary without fiscal year limitation, in such
amounts as may be specified from time to time
in appropriation Acts, to enable him to make
loans under this subchapter and to take the action authorized by subsection (f) of this section.
There shall also be deposited in the fund
amounts received by the Secretary as interest
payments and repayment of principal on loans
made under this subchapter and other property
or assets derived by him from his operations respecting such loans, from the sale of loans under
subsection (c) of this section, or from the sale of
assets.
(f) Actions to protect interest of United States in
event of default
The Secretary may take such action as he
deems appropriate to protect the interest of the
United States in the event of a default on a loan
made or guaranteed under this subchapter, including taking possession of, holding, and using
real property pledged as security for such a loan
or loan guarantee.
(July 1, 1944, ch. 373, title XIII, § 1308, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 927;
amended Pub. L. 94–460, title I, § 109(b)(2), (c),
Oct. 8, 1976, 90 Stat. 1950; Pub. L. 95–559, § 4(c),
Nov. 1, 1978, 92 Stat. 2132; Pub. L. 97–35, title IX,
§ 945, Aug. 13, 1981, 95 Stat. 577; Pub. L. 99–514, § 2,

§ 300e–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99–660, title
VIII, § 807, Nov. 14, 1986, 100 Stat. 3800.)
CODIFICATION
In subsec. (d)(2), ‘‘chapter 31 of title 31’’ and ‘‘that
chapter’’ substituted for ‘‘the Second Liberty Bond
Act’’ and ‘‘that Act’’, respectively, on authority of Pub.
L. 97–258, § 4(b), Sept. 13, 1982, 96 Stat. 1067, the first section of which enacted Title 31, Money and Finance.
AMENDMENTS
1986—Subsec. (c)(3). Pub. L. 99–514 substituted ‘‘Internal Revenue Code of 1986’’ for ‘‘Internal Revenue Code
of 1954’’, which for purposes of codification was translated as ‘‘title 26’’ thus requiring no change in text.
Subsec. (d)(2). Pub. L. 99–660 inserted ‘‘before October
1, 1986,’’ after ‘‘guarantees issued by him’’.
1981—Subsec. (b)(2). Pub. L. 97–35 inserted provisions
relating to changes in the rate of interest by the Secretary, and in cl. (D) made changes in nomenclature.
1978—Subsec. (d). Pub. L. 95–559, § 4(c)(2)(A), in pars.
(1) and (2) inserted ‘‘and to take the action authorized
by subsection (f) of this section’’ after ‘‘by him under
this subchapter’’.
Subsec. (e). Pub. L. 95–559, § 4(c)(2)(B), inserted ‘‘and
to take the action authorized by subsection (f) of this
section’’ after ‘‘loans under this subchapter’’.
Subsec. (f). Pub. L. 95–559, § 4(c)(1), added subsec. (f).
1976—Subsec. (a)(1)(A). Pub. L. 94–460, § 109(c)(1), substituted ‘‘for loans with similar maturities, terms, conditions, and security’’ for ‘‘for similar loans’’.
Subsec. (b)(2)(D). Pub. L. 94–460, § 109(c)(2), substituted
‘‘marketable obligations of the United States of comparable maturities, adjusted to provide for appropriate
administrative charges’’ for ‘‘loans guaranteed under
this subchapter’’.
Subsec. (c)(5). Pub. L. 94–460, § 109(b)(2), added par. (5).
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95–559 effective only for fiscal
years beginning on or after October 1, 1978, see section
4(d) of Pub. L. 95–559, set out as a note under section
300e–4 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
except that the amendment by section 109(c) of Pub. L.
94–460 applicable with respect to loan guarantees made
under section 300e–4 of this title after Sept. 30, 1976, see
section 118 of Pub. L. 94–460, set out as a note under section 300e of this title.

§ 300e–8. Authorization of appropriations
(a) For grants under section 300e–16 of this
title there is authorized to be appropriated
$1,000,000 for each of the fiscal years 1982, 1983,
and 1984.
(b) To meet the obligations of the loan fund
established under section 300e–7(e) of this title
resulting from defaults on loans made from the
fund and to meet the other obligations of the
fund, there is authorized to be appropriated to
the loan fund for fiscal years 1987, 1988, and 1989,
such sums as may be necessary.
(July 1, 1944, ch. 373, title XIII, § 1309, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 930;
amended Pub. L. 94–460, title I, § 113(c), Oct. 8,
1976, 90 Stat. 1954; Pub. L. 95–83, title I, § 105(b),
Aug. 1, 1977, 91 Stat. 384; Pub. L. 95–559, §§ 2(c),

Page 956

7(b), Nov. 1, 1978, 92 Stat. 2131, 2135; Pub. L. 97–35,
title IX, § 941(a), (b), Aug. 13, 1981, 95 Stat. 572;
Pub. L. 99–660, title VIII, §§ 803(b)(3), 811, Nov. 14,
1986, 100 Stat. 3800, 3801.)
AMENDMENTS
1986—Subsec. (a). Pub. L. 99–660, § 803(b)(3), struck out
par. (2) designation and struck out par. (1) which read
as follows: ‘‘For grants and contracts under sections
300e–2 and 300e–3 of this title there is authorized to be
appropriated $20,000,000 for the fiscal years 1982, 1983,
and 1984. No funds appropriated under this paragraph
may be expended or obligated for a grant or contract
unless the entity received a grant or contract under
section 242a or 242b of this title during or before the fiscal year 1981.’’
Subsec. (b). Pub. L. 99–660, § 811, amended subsec. (b)
generally. Prior to amendment, subsec. (b) read as follows: ‘‘To maintain in the loan fund established under
section 300e–7(e) of this title for the purpose of making
new loans a balance of at least $5,000,000 at the end of
each fiscal year and to meet the obligations of the loan
fund resulting from defaults on loans made from the
fund and to meet the other obligations of the fund,
there is authorized to be appropriated to the loan fund
for fiscal years 1982, 1983, and 1984, such sums as may be
necessary to assure such balance and meet such obligations.’’
1981—Subsec. (a). Pub. L. 97–35, § 941(a), substituted
provisions authorizing appropriations for fiscal years
1982, 1983, and 1984, and provisions respecting prior receipt of funds, for provisions authorizing appropriations for fiscal years ending June 30, 1974, 1975, and 1976,
and Sept. 30, 1977, 1978, 1979, 1980, and 1981.
Subsec. (b). Pub. L. 97–35, § 941(b), substituted provisions relating to maintenance of the loan fund for fiscal
years 1982, 1983, and 1984, for provisions relating to
maintenance of the loan fund for fiscal years ending
June 30, 1974, and 1975.
1978—Subsec. (a). Pub. L. 95–559 substituted ‘‘300e–3(b)
and 300e–16 of this title’’ for ‘‘and 300e–3(b) of this title’’
and ‘‘, $31,000,000 for the fiscal year ending September
30, 1979, $65,000,000 for the fiscal year ending September
30, 1980, and $68,000,000 for the fiscal year ending September 30, 1981’’ for ‘‘; and for the purpose of making
payments under grants and contracts under section
300e–3(b) of this title for the fiscal year ending September 30, 1979, there is authorized to be appropriated
$50,000,000’’.
1977—Subsec. (a). Pub. L. 95–83 substituted, where appearing the second time, ‘‘September 30, 1979’’ for ‘‘September 30, 1977’’.
1976—Subsec. (a). Pub. L. 94–460 substituted
‘‘$40,000,000 for the fiscal year ending June 30, 1976,
$45,000,000 for the fiscal year ending September 30, 1977,
and $45,000,000 for the fiscal year ending September 30,
1978;’’ for ‘‘and $85,000,000 for the fiscal year ending
June 30, 1976;’’ and ‘‘for the fiscal year ending September 30, 1977, there is authorized to be appropriated
$50,000,000’’ for ‘‘for the fiscal year ending June 30, 1977,
there is authorized to be appropriated $85,000,000’’.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 803(b)(3) of Pub. L. 99–660 not
applicable to any grant made or contract entered into
under this subchapter before Oct. 1, 1985, see section
803(c) of Pub. L. 99–660, set out as a note under section
300e–5 of this title.
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by section 7(b) of Pub. L. 95–559 effective
only for fiscal years beginning on or after Oct. 1, 1978,
see section 7(c) of Pub. L. 95–559, set out as an Effective
Date note under section 300e–16 of this title.

Page 957

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
see section 118 of Pub. L. 94–460, set out as a note under
section 300e of this title.

§ 300e–9. Employees’ health benefits plans
(a) Regulations; membership option
In accordance with regulations which the Secretary shall prescribe—
(1) each employer—
(A) which is required during any calendar
quarter to pay its employees the minimum
wage prescribed by section 206 of title 29 (or
would be required to pay its employees such
wage but for section 213(a) of title 29), and
(B) which during such calendar quarter
employed an average number of employees
of not less than 25, and
(2) any State and each political subdivision
thereof which during any calendar quarter employed an average number of employees of not
less than 25, as a condition of payment to the
State of funds under section 247b, 247c, or 300a
of this title,
which offers to its employees in the calendar
year beginning after such calendar quarter the
option of membership in a qualified health
maintenance organization which is engaged in
the provision of basic health services in a health
maintenance organization service area in which
at least 25 of such employees reside shall meet
the requirements of subsection (b) of this section with respect to any qualified health maintenance organization offered by the employer or
State or political subdivision.
(b) Nondiscriminatory contributions for services;
payroll deductions; effect on costs
(1) If a health benefits plan offered by an employer or a State or political subdivision includes contributions for services offered under
the plan, the employer or State or political subdivision shall make a contribution under the
plan for services offered by a qualified health
maintenance organization in an amount which
does not financially discriminate against an employee who enrolls in such organization. For
purposes of the preceding sentence, an employer’s or a State’s or political subdivision’s contribution does not financially discriminate if
the employer’s or State’s or political subdivision’s method of determining the contributions
on behalf of all employees is reasonable and is
designed to assure employees a fair choice
among health benefits plans.
(2) Each employer or State or political subdivision which provides payroll deductions as a
means of paying employees’ contributions for
health benefits or which provides a health benefits plan to which an employee contribution is
not required shall, with the consent of an employee who exercises option of membership in a
qualified health maintenance organization, arrange for the employee’s contribution for membership in the organization to be paid through
payroll deductions.
(3) No employer or State or political subdivision shall be required to pay more for health
benefits as a result of the application of this
subsection than would otherwise be required by

§ 300e–9

any prevailing collective bargaining agreement
or other legally enforceable contract for the provision of health benefits between the employer
or State or political subdivision and its employees.
(c) ‘‘Qualified health maintenance organization’’
defined
For purposes of this section, the term ‘‘qualified health maintenance organization’’ means (1)
a health maintenance organization which has
provided assurances satisfactory to the Secretary that it provides basic and supplemental
health services to its members in the manner
prescribed by section 300e(b) of this title and
that it is organized and operated in the manner
prescribed by section 300e(c) of this title, and (2)
an entity which proposes to become a health
maintenance organization and which the Secretary determines will when it becomes operational provide basic and supplemental health
services to its members in the manner prescribed by section 300e(b) of this title and will be
organized and operated in the manner prescribed
by section 300e(c) of this title.
(d) Civil penalty; notice and presentation of
views; review
(1) Any employer who knowingly does not
comply with one or more of the requirements of
paragraph (1) or (2) of subsection (b) of this section shall be subject to a civil penalty of not
more than $10,000. If such noncompliance continues, a civil penalty may be assessed and collected under this subsection for each thirty-day
period such noncompliance continues. Such penalty may be assessed by the Secretary and collected in a civil action brought by the United
States in a United States district court.
(2) In any proceeding by the Secretary to assess a civil penalty under this subsection, no
penalty shall be assessed until the employer
charged shall have been given notice and an opportunity to present its views on such charge. In
determining the amount of the penalty, or the
amount agreed upon in compromise, the Secretary shall consider the gravity of the noncompliance and the demonstrated good faith of
the employer charged in attempting to achieve
rapid compliance after notification by the Secretary of a noncompliance.
(3) In any civil action brought to review the
assessment of a civil penalty assessed under this
subsection, the court shall, at the request of any
party to such action, hold a trial de novo on the
assessment of such civil penalty and in any civil
action to collect such a civil penalty, the court
shall, at the request of any party to such action,
hold a trial de novo on the assessment of such
civil penalty unless in a prior civil action to review the assessment of such penalty the court
held a trial de novo on such assessment.
(e) ‘‘Employer’’ defined
For purposes of this section, the term ‘‘employer’’ does not include (1) the Government of
the United States, the government of the District of Columbia or any territory or possession
of the United States, a State or any political
subdivision thereof, or any agency or instrumentality (including the United States Postal Service and Postal Regulatory Commission) of any

§ 300e–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of the foregoing, except that such term includes
nonappropriated fund instrumentalities of the
Government of the United States; or (2) a
church, convention or association of churches,
or any organization operated, supervised or controlled by a church, convention or association of
churches which organization (A) is an organization described in section 501(c)(3) of title 26, and
(B) does not discriminate (i) in the employment,
compensation, promotion, or termination of employment of any personnel, or (ii) in the extension of staff or other privileges to any physician
or other health personnel, because such persons
seek to obtain or obtained health care, or participate in providing health care, through a
health maintenance organization.
(f) Termination of payment for failure to comply
If the Secretary, after reasonable notice and
opportunity for a hearing to a State, finds that
it or any of its political subdivisions has failed
to comply with paragraph (1) or (2) of subsection
(b) of this section, the Secretary shall terminate
payments to such State under sections 247b,
247c, and 300a of this title and notify the Governor of such State that further payments under
such sections will not be made to the State until
the Secretary is satisfied that there will no
longer be any such failure to comply.
(July 1, 1944, ch. 373, title XIII, § 1310, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 930;
amended Pub. L. 94–460, title I, § 110(a), Oct. 8,
1976, 90 Stat. 1950; Pub. L. 95–559, §§ 8, 12(a)(1),
Nov. 1, 1978, 92 Stat. 2135, 2140; Pub. L. 96–32,
§ 2(f), July 10, 1979, 93 Stat. 82; Pub. L. 97–35, title
IX, §§ 942(a)(3), (4), 946, Aug. 13, 1981, 95 Stat. 573,
577; Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095;
Pub. L. 99–660, title VIII, § 808, Nov. 14, 1986, 100
Stat. 3801; Pub. L. 100–517, §§ 4(b), 7(a)(1), (2), (b),
Oct. 24, 1988, 102 Stat. 2578, 2580; Pub. L. 109–435,
title VI, § 604(f), Dec. 20, 2006, 120 Stat. 3242.)
AMENDMENTS
2006—Subsec. (e). Pub. L. 109–435 substituted ‘‘Postal
Regulatory Commission’’ for ‘‘Postal Rate Commission’’.
1988—Pub. L. 100–517, § 7(b), amended section generally, substituting subsecs. (a) to (f) for former subsecs.
(a) to (g).
Subsec. (b). Pub. L. 100–517, §§ 4(b), 7(a)(1)(A), in introductory provisions, substituted ‘‘or a State or political
subdivision’’ for ‘‘subject to subsection (a) of this section’’, in par. (1), inserted ‘‘and provides at least 90 percent of such services through physicians described in
section 300e(b)(3)(A) of this title’’, in par. (2), inserted
‘‘and provides no more than 10 percent of such services
through physicians who are not described in section
300e(b)(3)(A) of this title’’, and in concluding provisions, substituted ‘‘employer or State or political subdivision pursuant’’ for ‘‘employer pursuant’’.
Subsec. (c). Pub. L. 100–517, § 7(a)(1)(B), (2), substituted ‘‘No employer or State or political subdivision’’ for ‘‘No employer’’, ‘‘between the employer or
State or political subdivision’’ for ‘‘between the employer’’, and ‘‘Each employer or State or political subdivision’’ for ‘‘Each employer’’, and inserted at end ‘‘If
a health benefits plan offered by an employer or a State
or political subdivision under subsection (a) of this section includes contributions for services offered under
the plan, the employer or State or political subdivision
shall make a contribution under the plan for services
offered by a qualified health maintenance organization
in an amount which does not financially discriminate
against an employee who enrolls in such organization.

Page 958

For purposes of the preceding sentence, an employer’s
or a State’s or political subdivision’s contribution does
not financially discriminate if the employer’s or
State’s or political subdivision’s method of determining the contributions on behalf of all employees is reasonable and is designed to assure employees a fair
choice among health benefits plans.’’
1986—Subsec. (d). Pub. L. 99–660 struck out last sentence which read as follows: ‘‘Every two years (or such
longer period as the Secretary may by regulation prescribe) after the date a health maintenance organization becomes a qualified health maintenance organization under this subsection, the health maintenance organization must demonstrate to the Secretary that it
is qualified within the meaning of this subsection.’’
Subsec. (f). Pub. L. 99–514 substituted ‘‘Internal Revenue Code of 1986’’ for ‘‘Internal Revenue Code of 1954’’,
which for purposes of codification was translated as
‘‘title 26’’ thus requiring no change in text.
1981—Subsec. (b)(1). Pub. L. 97–35, § 942(a)(3)(A), substituted provisions respecting provision of more than
one-half of the basic services provided by physicians,
for provisions respecting provision of basic services.
Subsec. (b)(2). Pub. L. 97–35, § 942(a)(3)(B), (4), inserted
reference to provision by physicians, added cl. (B), and
redesignated former cl. (B) as (C).
Subsec. (d). Pub. L. 97–35, § 946(a), inserted provisions
relating to demonstration of continued qualification of
organization.
Subsec. (f)(1). Pub. L. 97–35, § 946(b), inserted reference
to United States nonappropriated fund instrumentalities.
1979—Subsec. (e)(1). Pub. L. 96–32 substituted ‘‘subsection (a), (b), or (c)’’ for ‘‘subsection (a)’’.
1978—Subsec. (b). Pub. L. 95–559, § 8(b), substituted in
par. (1) ‘‘through physicians or other health professionals who are members of the staff of the organization or a medical group (or groups)’’ for ‘‘(A) without
the use of an individual practice association and (B)
without the use of contracts (except for contracts for
unusual or infrequently used services) with health professionals’’ and in par. (2) ‘‘(B) a combination of such
association (or associations), medical group (or
groups), staff, and individual physicians and other
health professionals under contract with the organization’’ for ‘‘(B) health professionals who have contracted
with the health maintenance organization for the provision of such services, or (C) a combination of such association (or associations) or health professionals
under contract with the organization’’.
Subsec. (c). Pub. L. 95–559, § 8(a), inserted provision
that each employer which provides payroll deductions
as a means of paying employees’ contributions for
health benefits or which provides a health benefits plan
to which an employee contribution is not required and
which is required by subsection (a) of this section to
offer his employees the option of membership in a
qualified health maintenance organization shall, with
the consent of an employee who exercises such option,
arrange for the employee’s contribution for such membership to be paid through payroll deductions.
Subsec. (h). Pub. L. 95–559, § 12(a)(1), struck out subsec. (h) which provided that the duties and functions of
the Secretary, insofar as they involve determinations
as to whether an organization is a qualified health
maintenance organization within the meaning of subsection (d) of this section, be administered through the
Assistant Secretary for Health and in the Office of the
Assistant Secretary for Health, and the administration
of such duties and functions be integrated with the administration of section 300e–11(a) of this title.
1976—Subsec. (a). Pub. L. 94–460, § 110(a)(1), substituted reference to each employer which is now or
hereafter required for reference to each employer which
is required, reference to basic health services in health
maintenance organization service areas in which at
least 25 of such employees reside for reference to basic
and supplemental health services in the areas in which
such employees reside, and inserted provisions requiring certain States and political subdivisions thereof to

Page 959

TITLE 42—THE PUBLIC HEALTH AND WELFARE

include in any health benefits plan the option of membership in qualified health maintenance organizations
as a condition of payment to the State of funds under
section 246(d), 247b, 247c, 300a, 300m–4, or 300p–3 of this
title, and that the offer of membership in such an organization be first made to the employees’ representative, if any, and then be made to each employee if the
offer is accepted by the representative.
Subsec. (b)(1). Pub. L. 94–460, § 110(a)(2), substituted
‘‘(A) without the use of an individual practice association and (B) without the use of contracts (except for
contracts for unusual or infrequently used services)
with health professionals’’ for ‘‘through professionals
who are members of the staff of the organization or a
medical group (or groups)’’.
Subsec. (b)(2). Pub. L. 94–460, § 110(a)(2), substituted
‘‘basic health services through (A) an individual practice association (or associations), (B) health professionals who have contracted with the health maintenance organization for the provision of such services,
or (C) a combination of such association (or associations) or health professionals under contract with the
organization’’ for ‘‘such services through an individual
practice association (or associations)’’.
Subsec. (c). Pub. L. 94–460, § 110(a)(3), struck out provision that failure of any employer to comply with the
requirements of subsection (a) of this section be considered a willful violation of section 215 of title 29.
Subsecs. (e) to (h). Pub. L. 94–460, § 110(a)(4), added
subsecs. (e) to (h).
EFFECTIVE DATE OF 1988 AMENDMENT
Section 7(b) of Pub. L. 100–517 provided that the
amendment made by section 7(b) is effective 7 years
after Oct. 24, 1988.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1981 AMENDMENT
Section 942(a)(5) of Pub. L. 97–35 provided that: ‘‘The
amendment made by paragraph (3)(A) [amending this
section] shall apply with respect to the offering of a
health maintenance organization in accordance with
section 1310(b)(1) of the Public Health Service Act [subsec. (b)(1) of this section] after four years after the date
the organization becomes a qualified health maintenance organization for purposes of section 1310 of such
Act [this section] if the health maintenance organization provides assurances satisfactory to the Secretary
that upon the expiration of such four years it will provide more than one half of its basic health services
which are provided by physicians through physicians or
other health professionals who are members of the staff
of the organization or a medical group (or groups).’’
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by section 110(a)(1), (2) of Pub. L. 94–460
applicable with respect to calendar quarters which
began after Oct. 8, 1976, and amendment by section
110(a)(3), (4) of Pub. L. 94–460 applicable with respect to
failures of employers to comply with section 300e–9 of
this title after Oct. 8, 1976, see section 118 of Pub. L.
94–460, set out as a note under section 300e of this title.
COLLECTIVE BARGAINING AGREEMENTS IN EFFECT ON
OCTOBER 24, 1988, UNAFFECTED
Section 7(a)(3) of Pub. L. 100–517 provided that:
‘‘Nothing in section 1310 of the Public Health Service
Act (42 U.S.C. 300e–9), as amended by this Act, shall be
construed to supersede any provision of a collective
bargaining agreement in effect on the date of enactment of this Act [Oct. 24, 1988].’’

§ 300e–10

§ 300e–10. Restrictive State laws and practices
(a) Entities operating as health maintenance organizations
In the case of any entity—
(1) which cannot do business as a health
maintenance organization in a State in which
it proposes to furnish basic and supplemental
health services because that State by law, regulation, or otherwise—
(A) requires as a condition to doing business in that State that a medical society approve the furnishing of services by the entity,
(B) requires that physicians constitute all
or a percentage of its governing body,
(C) requires that all physicians or a percentage of physicians in the locale participate or be permitted to participate in the
provision of services for the entity,
(D) requires that the entity meet requirements for insurers of health care services
doing business in that State respecting initial capitalization and establishment of financial reserves against insolvency, or
(E) imposes requirements which would prohibit the entity from complying with the requirements of this subchapter, and
(2) for which a grant, contract, loan, or loan
guarantee was made under this subchapter or
which is a qualified health maintenance organization for purposes of section 300e–9 of this
title (relating to employees’ health benefits
plans),
such requirements shall not apply to that entity
so as to prevent it from operating as a health
maintenance organization in accordance with
section 300e of this title.
(b) Advertising
No State may establish or enforce any law
which prevents a health maintenance organization for which a grant, contract, loan, or loan
guarantee was made under this subchapter or
which is a qualified health maintenance organization for purposes of section 300e–9 of this title
(relating to employees’ health benefits plans),
from soliciting members through advertising its
services, charges, or other nonprofessional aspects of its operation. This subsection does not
authorize any advertising which identifies, refers to, or makes any qualitative judgement
concerning, any health professional who provides services for a health maintenance organization.
(c) Digest of State laws, regulations, and practices; legal consultative assistance
The Secretary shall, within 6 months after October 8, 1976, develop a digest of State laws, regulations, and practices pertaining to development, establishment, and operation of health
maintenance organizations which shall be updated at least annually and relevant sections of
which shall be provided to the Governor of each
State annually. Such digest shall indicate which
State laws, regulations, and practices appear to
be inconsistent with the operation of this section. The Secretary shall also insure that appropriate legal consultative assistance is available
to the States for the purpose of complying with
the provisions of this section.

§ 300e–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XIII, § 1311, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 931;
amended Pub. L. 94–460, title I, § 114, Oct. 8, 1976,
90 Stat. 1954; Pub. L. 99–660, title VIII, § 809, Nov.
14, 1986, 100 Stat. 3801; Pub. L. 100–517, § 8, Oct. 24,
1988, 102 Stat. 2583.)
PRIOR PROVISIONS
A prior section 1311 of act July 1, 1944, was classified
to section 211a of this title prior to repeal by Pub. L.
93–222, § 7(b).
AMENDMENTS
1988—Subsec. (a)(1)(E). Pub. L. 100–517 added subpar.
(E).
1986—Subsec. (c). Pub. L. 99–660 substituted ‘‘annually’’ for ‘‘quarterly’’ after ‘‘at least’’.
1976—Subsec. (c). Pub. L. 94–460 added subsec. (c).
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 effective Oct. 8, 1976,
see section 118 of Pub. L. 94–460, set out as a note under
section 300e of this title.

§ 300e–11. Continued regulation of health maintenance organizations
(a) Determination of deficiency
If the Secretary determines that an entity
which received a grant, contract, loan, or loan
guarantee under this subchapter as a health
maintenance organization or which was included
in a health benefits plan offered to employees
pursuant to section 300e–9 of this title—
(1) fails to provide basic and supplemental
services to its members,
(2) fails to provide such services in the manner prescribed by section 300e(b) of this title,
or
(3) is not organized or operated in the manner prescribed by section 300e(c) of this title,
the Secretary may take the action authorized
by subsection (b) of this section.
(b) Action by Secretary upon determination
(1) If the Secretary makes, with respect to any
entity which provided assurances to the Secretary under section 300e–9(d)(1) 1 of this title, a
determination described in subsection (a) of this
section, the Secretary shall notify the entity in
writing of the determination. Such notice shall
specify the manner in which the entity has not
complied with such assurances and direct that
the entity initiate (within 30 days of the date
the notice is issued by the Secretary or within
such longer period as the Secretary determines
is reasonable) such action as may be necessary
to bring (within such period as the Secretary
shall prescribe) the entity into compliance with
the assurances. If the entity fails to initiate corrective action within the period prescribed by
the notice or fails to comply with the assurances within such period as the Secretary prescribes, then after the Secretary provides the
entity a reasonable opportunity for reconsider1 See

References in Text note below.

Page 960

ation of his determination, including, at the entity’s election, a fair hearing (A) the entity
shall not be a qualified health maintenance organization for purposes of section 300e–9 of this
title until such date as the Secretary determines that it is in compliance with the assurances, and (B) each employer which has offered
membership in the entity in compliance with
section 300e–9 of this title, each lawfully recognized collective bargaining representative or
other employee representative which represents
the employees of each such employer, and the
members of such entity shall be notified by the
entity that the entity is not a qualified health
maintenance organization for purposes of such
section. The notice required by clause (B) of the
preceding sentence shall contain, in readily understandable language, the reasons for the determination that the entity is not a qualified
health maintenance organization. The Secretary
shall publish in the Federal Register each determination referred to in this paragraph.
(2) If the Secretary makes, with respect to an
entity which has received a grant, contract,
loan, or loan guarantee under this subchapter, a
determination described in subsection (a) of this
section, the Secretary may, in addition to any
other remedies available to him, bring a civil
action in the United States district court for the
district in which such entity is located to enforce its compliance with the assurances it furnished respecting the provision of basic and supplemental health services or its organization or
operation, as the case may be, which assurances
were made in connection with its application
under this subchapter for the grant, contract,
loan, or loan guarantee.
(July 1, 1944, ch. 373, title XIII, § 1312, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 931;
amended Pub. L. 94–460, title I, § 111, Oct. 8, 1976,
90 Stat. 1952; Pub. L. 95–559, § 12(a)(2), Nov. 1,
1978, 92 Stat. 2140; Pub. L. 97–35, title IX, § 949(a),
Aug. 13, 1981, 95 Stat. 578.)
REFERENCES IN TEXT
Section 300e–9(d)(1) of this title, referred to in subsec.
(b)(1), was redesignated section 300e–9(c)(1) of this title
by Pub. L. 100–517, § 7(b), Oct. 24, 1988, 102 Stat. 2580.
PRIOR PROVISIONS
A prior section 1312 of act July 1, 1944, was classified
to section 212a of this title prior to repeal by Pub. L.
93–222, § 7(b).
AMENDMENTS
1981—Subsec. (b)(1). Pub. L. 97–35 inserted provisions
relating to opportunity for reconsideration of determination of Secretary.
1978—Subsec. (c). Pub. L. 95–559 struck out subsec. (c)
which provided that the Secretary, acting through the
Assistant Secretary for Health, administer subsections
(a) and (b) of this section in the Office of the Assistant
Secretary for Health.
1976—Subsec. (a). Pub. L. 94–460, § 111(a), substituted
‘‘the Secretary may take the action authorized by subsection (b) of this section’’ for ‘‘the Secretary may, in
addition to any other remedies available to him, bring
a civil action in the United States district court for the
district in which such entity is located to enforce its
compliance with any assurances it furnished him respecting the provision of basic and supplemental health
services or its organization or operation, as the case
may be, which assurances were made under section

Page 961

TITLE 42—THE PUBLIC HEALTH AND WELFARE

300e–9 of this title or when application was made under
this subchapter for a grant, contract, loan, or loan
guarantee’’.
Subsecs. (b), (c). Pub. L. 94–460, § 111(b), (c), added subsec. (b), redesignated former subsec. (b) as (c), and substituted ‘‘acting through the Assistant Secretary for
Health, shall administer subsections (a) and (b) of this
section’’ for ‘‘through the Assistant Secretary for
Health, shall administer subsection (a) of this section’’.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94–460 applicable with respect
to determinations of the Secretary of Health, Education, and Welfare described in subsec. (a) of this section and made after Oct. 8, 1976, see section 118 of Pub.
L. 94–460, set out as a note under section 300e of this
title.

§ 300e–12. Limitation on source of funding for
health maintenance organizations
No funds appropriated under any provision of
this chapter (except as provided in sections
254b 1 and 254b of this title) other than this subchapter may be used—
(1) for grants or contracts for surveys or
other activities to determine the feasibility of
developing or expanding health maintenance
organizations or other entities which provide,
directly or indirectly, health services to a defined population on a prepaid basis;
(2) for grants or contracts, or for payments
under loan guarantees, for planning projects
for the establishment or expansion of such organizations or entities;
(3) for grants or contracts, or for payments
under loan guarantees, for projects for the initial development or expansion of such organizations or entities; or
(4) for loans, or for payments under loan
guarantees, to assist in meeting the costs of
the initial operation after establishment or
expansion of such organizations or entities or
in meeting the costs of such organizations in
acquiring or constructing ambulatory health
care facilities.
(July 1, 1944, ch. 373, title XIII, § 1313, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 932;
amended Pub. L. 95–559, § 5(b), Nov. 1, 1978, 92
Stat. 2133; Pub. L. 95–626, title I, § 107, Nov. 10,
1978, 92 Stat. 3562; Pub. L. 107–251, title VI,
§ 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L.
108–163, § 2(m)(2), Dec. 6, 2003, 117 Stat. 2023.)
REFERENCES IN TEXT
The reference to section 254b of this title the first
place appearing in text was in the original a reference
to section 329, meaning section 329 of act July 1, 1944,
which was omitted in the general amendment of subpart I (§ 254b et seq.) of part D of this subchapter by
Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626.
AMENDMENTS
2003—Pub. L. 108–163 substituted ‘‘254b and 254b’’ for
‘‘254b, 254c, and 254b(h)’’ in introductory provisions.
2002—Pub. L. 107–251 substituted ‘‘254b(h)’’ for ‘‘256’’
in introductory provisions.
1978—Pub. L. 95–626 inserted ‘‘(except as provided in
sections 254b, 254c, and 256 of this title)’’ after ‘‘under
any provision of this chapter’’ in provisions preceding
par. (1).
Par. (4). Pub. L. 95–559 inserted ‘‘or in meeting the
costs of such organizations in acquiring or constructing
ambulatory health care facilities’’ after ‘‘or entities’’.
1 See

References in Text notes below.

§ 300e–14

EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.

§ 300e–13. Repealed. Pub. L. 97–35, title IX,
§ 949(b), Aug. 13, 1981, 95 Stat. 578
Section, acts July 1, 1944, ch. 373, title XIII, § 1314, as
added Dec. 29, 1973, Pub. L. 93–222, § 2, 87 Stat. 932;
amended Oct. 8, 1976, Pub. L. 94–460, title I, § 115, 90
Stat. 1954; Nov. 1, 1978, Pub. L. 95–559, § 13, 92 Stat. 2140,
required the Comptroller General to: (a) evaluate the
operations, particularly, specified aspects of the operations, of at least ten or one-half, whichever is greater,
of the health maintenance organizations for which assistance was provided under sections 300e–2, 300e–3, and
300e–4 of this title, and which, by Dec. 31, 1976, were designated by the Secretary under section 300e–9(d) of this
title as qualified health maintenance organizations, to
Congress by June 30, 1978; (b) conduct a study of the
economic effects on employers resulting from their
compliance with the requirements of section 300e–9 of
this title and report to Congress not later than 36
months after Dec. 29, 1973; (c) evaluate the operations
of health maintenance organizations in comparison
with others in distinct categories, in comparison with
alternative forms of health care delivery, and their impact on the health of the public and report to Congress
not later than 36 months after Dec. 29, 1973; and (d)
evaluate the adequacy and effectiveness of the policies
and procedures of the Secretary for the management of
the grant and loan programs established by this subchapter and the adequacy of the amounts of assistance
available under these programs and report to Congress
not later than May 1, 1979.

§ 300e–14. Annual report
(a) The Secretary shall periodically review the
programs of assistance authorized by this subchapter and make an annual report to the Congress of a summary of the activities under each
program. The Secretary shall include in such
summary—
(1) a summary of each grant, contract, loan,
or loan guarantee made under this subchapter
in the period covered by the report and a list
of the health maintenance organizations
which during such period became qualified
health maintenance organizations for purposes
of section 300e–9 of this title;
(2) the statistics and other information reported in such period to the Secretary in accordance with section 300e(c)(11) 1 of this title;
(3) findings with respect to the ability of the
health maintenance organizations assisted
under this subchapter—
(A) to operate on a fiscally sound basis
without continued Federal financial assistance,
(B) to meet the requirements of section
300e(c) of this title respecting their organization and operation,
(C) to provide basic and supplemental
health services in the manner prescribed by
section 300e(b) of this title,
(D) to include indigent and high-risk individuals in their membership, and
(E) to provide services to medically underserved populations; and
(4) findings with respect to—
1 See

References in Text note below.

§ 300e–14a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the operation of distinct categories of
health maintenance organizations in comparison with each other,
(B) health maintenance organizations as a
group in comparison with alternative forms
of health care delivery, and
(C) the impact that health maintenance
organizations, individually, by category, and
as a group, have on the health of the public.
(b) The Office of Management and Budget may
review the Secretary’s report under subsection
(a) of this section before its submission to the
Congress, but the Office may not revise the report or delay its submission, and it may submit
to the Congress its comments (and those of
other departments or agencies of the Government) respecting such report.
(July 1, 1944, ch. 373, title XIII, § 1315, as added
Pub. L. 93–222, § 2, Dec. 29, 1973, 87 Stat. 933.)
REFERENCES IN TEXT
Section 300e(c)(11) of this title, referred to in subsec.
(a)(2), was redesignated section 300e(c)(9) of this title by
Pub. L. 97–35, title IX, § 942(d)(1), Aug. 13, 1981, 95 Stat.
574, and redesignated section 300e(c)(8) of this title by
Pub. L. 100–517, § 5(b), Oct. 24, 1988, 102 Stat. 2579.

§ 300e–14a. Health services for Indians and domestic agricultural migratory and seasonal
workers
The Secretary of Health and Human Services,
in connection with existing authority (except
section 254b 1 of this title) for the provisions of
health services to domestic agricultural migratory workers, to persons who perform seasonal
agricultural services similar to the services performed by such workers, and to the families of
such workers and persons, is authorized to arrange for the provision of health services to
such workers and persons and their families
through health maintenance organizations. In
carrying out this section the Secretary may
only use sums appropriated after December 29,
1973.
(Pub. L. 93–222, § 6(b), Dec. 29, 1973, 87 Stat. 936;
Pub. L. 95–626, title I, § 102(b)(2), Nov. 10, 1978, 92
Stat. 3551; Pub. L. 96–88, title V, § 509(b), Oct. 17,
1979, 93 Stat. 695.)
REFERENCES IN TEXT
Section 254b of this title, referred to in text, was in
the original a reference to section 329 of the Public
Health Service Act, act July 1, 1944, which was omitted
in the general amendment of subpart I (§ 254b et seq.) of
part D of subchapter II of this chapter by Pub. L.
104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Section 2 of Pub.
L. 104–299 enacted a new section 330 of act July 1, 1944,
which is classified to section 254b of this title.
CODIFICATION
Section was enacted as part of the Health Maintenance Organization Act of 1973, and not as part of the
Public Health Service Act which comprises this chapter.
AMENDMENTS
1978—Pub. L. 95–626 substituted ‘‘section 254b’’ for
‘‘section 247d’’.
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Wel1 See

References in Text note below.

Page 962

fare’’ in text, pursuant to section 509(b) of Pub. L. 96–88
which is classified to section 3508(b) of Title 20, Education.

§ 300e–15. Repealed. Pub. L. 97–35, title IX,
§ 949(b), Aug. 13, 1981, 95 Stat. 578
Section, act July 1, 1944, ch. 373, title XIII, § 1316, as
added Oct. 8, 1976, Pub. L. 94–460, title I, § 116, 90 Stat.
1954, related to administration of programs.

§ 300e–16. Training and technical assistance
(a) National Health Maintenance Organization
Intern Program
(1) The Secretary shall establish a National
Health Maintenance Organization Intern Program (hereinafter in this subsection referred to
as the ‘‘Program’’) for the purpose of providing
training to individuals to become administrators and medical directors of health maintenance organizations or to assume other managerial positions with health maintenance organizations. Under the Program the Secretary may
directly provide internships for such training
and may make grants to or enter into contracts
with health maintenance organizations and
other entities to provide such internships.
(2) No internship may be provided by the Secretary and no grant may be made or contract
entered into by the Secretary for the provision
of internships unless an application therefor has
been submitted to and approved by the Secretary. Such an application shall be in such
form and contain such information, and be submitted to the Secretary in such manner, as the
Secretary shall prescribe. Section 300e–5 of this
title does not apply to an application submitted
under this section.
(3) Internships under the Program shall provide for such stipends and allowances (including
travel and subsistence expenses and dependency
allowances) for the recipients of the internships
as the Secretary deems necessary. An internship
provided an individual for training at a health
maintenance organization or any other entity
shall also provide for payments to be made to
the organization or other entity for the cost of
support services (including the cost of salaries,
supplies, equipment, and related items) provided
such individual by such organization or other
entity. The amount of any such payments to
any organization or other entity shall be determined by the Secretary and shall bear a direct
relationship to the reasonable costs of the organization or other entity for establishing and
maintaining its training programs.
(4) Payments under grants under the Program
may be made in advance or by way of reimbursement, and at such intervals and on such conditions, as the Secretary finds necessary.
(b) Technical assistance
The Secretary shall provide technical assistance (1) to entities intending to become a qualified health maintenance organization within the
meaning of section 300e–9(d) 1 of this title, and
(2) to health maintenance organizations. The
Secretary may provide such technical assistance
through grants to public and nonprofit private
1 See

References in Text note below.

Page 963

TITLE 42—THE PUBLIC HEALTH AND WELFARE

entities and contracts with public and private
entities.
(c) Amounts provided in advance in appropriation acts
The authority of the Secretary to enter into
contracts under subsections (a) and (b) of this
section shall be effective for any fiscal year only
to such extent or in such amounts as are provided in advance by appropriation Acts.
(July 1, 1944, ch. 373, title XIII, § 1317, as added
Pub. L. 95–559, § 7(a), Nov. 1, 1978, 92 Stat. 2134;
amended Pub. L. 99–660, title VIII, § 803(b)(4),
Nov. 14, 1986, 100 Stat. 3800.)
REFERENCES IN TEXT
Section 300e–9(d) of this title, referred to in subsec.
(b), was redesignated section 300e–9(c) of this title by
Pub. L. 100–517, § 7(b), Oct. 24, 1988, 102 Stat. 2580.
AMENDMENTS
1986—Subsec. (b). Pub. L. 99–660 redesignated cls. (2)
and (3) as (1) and (2), respectively, and struck out
former cl. (1) which read as follows: ‘‘to entities in connection with projects for which assistance is being provided under section 300e–2 or 300e–3 of this title,’’.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 not applicable to any
grant made or contract entered into under this subchapter before Oct. 1, 1985, see section 803(c) of Pub. L.
99–660, set out as a note under section 300e–5 of this
title.
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.
EFFECTIVE DATE
Section 7(c) of Pub. L. 95–559 provided that: ‘‘The
amendments made by this section [enacting this section and amending section 300e–8 of this title] shall
only be effective for fiscal years beginning on or after
October 1, 1978.’’

§ 300e–17. Financial disclosure
(a) Financial information reported to Secretary
Each health maintenance organization shall,
in accordance with regulations of the Secretary,
report to the Secretary financial information
which shall include the following:
(1) Such information as the Secretary may
require demonstrating that the health maintenance organization has a fiscally sound operation.
(2) A copy of the report, if any, filed with the
Centers for Medicare & Medicaid Services containing the information required to be reported under section 1320a–3 of this title by
disclosing entities and the information required to be supplied under section 1396a(a)(38)
of this title.
(3) A description of transactions, as specified
by the Secretary, between the health maintenance organization and a party in interest.
Such transactions shall include—
(A) any sale or exchange, or leasing of any
property between the health maintenance
organization and a party in interest;
(B) any furnishing for consideration of
goods, services (including management services), or facilities between the health maintenance organization and a party in interest,

§ 300e–17

but not including salaries paid to employees
for services provided in the normal course of
their employment and health services provided to members by hospitals and other
providers and by staff, medical group (or
groups), individual practice association (or
associations), or any combination thereof;
and
(C) any lending of money or other extension of credit between a health maintenance
organization and a party in interest.
The Secretary may require that information reported respecting a health maintenance organization which controls, is controlled by, or is
under common control with, another entity be
in the form of a consolidated financial statement for the organization and such entity.
(b) ‘‘Party in interest’’ defined
For the purposes of this section the term
‘‘party in interest’’ means:
(1) any director, officer, partner, or employee responsible for management or administration of a health maintenance organization, any person who is directly or indirectly
the beneficial owner of more than 5 per centum of the equity of the organization, any person who is the beneficial owner of a mortgage,
deed of trust, note, or other interest secured
by, and valuing more than 5 per centum of the
health maintenance organization, and, in the
case of a health maintenance organization organized as a nonprofit corporation, an incorporator or member of such corporation under
applicable State corporation law;
(2) any entity in which a person described in
paragraph (1)—
(A) is an officer or director;
(B) is a partner (if such entity is organized
as a partnership);
(C) has directly or indirectly a beneficial
interest of more than 5 per centum of the equity; or
(D) has a mortgage, deed of trust, note, on
other interest valuing more than 5 per centum of the assets of such entity;
(3) any person directly or indirectly controlling, controlled by, or under common control
with a health maintenance organization; and
(4) any spouse, child, or parent of an individual described in paragraph (1).
(c) Information availability
Each health maintenance organization shall
make the information reported pursuant to subsection (a) of this section available to its enrollees upon reasonable request.
(d) Evaluation of transactions
The Secretary shall, as he deems necessary,
conduct an evaluation of transactions reported
to the Secretary under subsection (a)(3) of this
section for the purpose of determining their adverse impact, if any, on the fiscal soundness and
reasonableness of charges to the health maintenance organization with respect to which they
transpired. The Secretary shall evaluate the reported transactions of not less than five, or if
there are more than twenty health maintenance
organizations reporting such transactions, not
less than one-fourth of the health maintenance

§ 300f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 964

organizations reporting any such transactions
under subsection (a)(3) of this section.

SUBCHAPTER XII—SAFETY OF PUBLIC
WATER SYSTEMS

(e) Repealed. Pub. L. 99–660, title VIII, § 810, Nov.
14, 1986, 100 Stat. 3801

PART A—DEFINITIONS

(f) Rates
Nothing in this section shall be construed to
confer upon the Secretary any authority to approve or disapprove the rates charged by any
health maintenance organization.
(g) Annual financial statement
Any health maintenance organization failing
to file with the Secretary the annual financial
statement required in subsection (a) of this section shall be ineligible for any Federal assistance under this subchapter until such time as
such statement is received by the Secretary and
shall not be a qualified health maintenance organization for purposes of section 300e–9 of this
title.
(h) Penalties
Whoever knowingly and willfully makes or
causes to be made any false statement or representation of a material fact in any statement
filed pursuant to this section shall be guilty of
a felony and upon conviction thereof shall be
fined not more than $25,000 or imprisoned for not
more than five years, or both.
(July 1, 1944, ch. 373, title XIII, § 1318, as added
Pub. L. 95–559, § 9(a), Nov. 1, 1978, 92 Stat. 2135;
amended Pub. L. 97–35, title IX, § 948, Aug. 13,
1981, 95 Stat. 577; Pub. L. 99–660, title VIII, § 810,
Nov. 14, 1986, 100 Stat. 3801; Pub. L. 108–173, title
IX, § 900(e)(2)(E), Dec. 8, 2003, 117 Stat. 2372.)
AMENDMENTS
2003—Subsec. (a)(2). Pub. L. 108–173 substituted ‘‘Centers for Medicare & Medicaid Services’’ for ‘‘Health
Care Financing Administration’’.
1986—Subsec. (e). Pub. L. 99–660 struck out subsec. (e)
which read as follows: ‘‘The Secretary shall file an annual report with the Congress on the operation of this
section. Such report shall include—
‘‘(1) an enumeration of standards and norms utilized to make the evaluations required under subsection (d) of this section;
‘‘(2) an assessment of the degree of conformity or
nonconformity of each health maintenance organization evaluated by the Secretary under subsection (d)
of this section with such standards and norms;
‘‘(3) what action, if any, the Secretary considers
necessary under section 300e–11 of this title with respect to health maintenance organizations evaluated
under subsection (d) of this section.’’
1981—Subsec. (a). Pub. L. 97–35, § 948(a), (b), in par. (2)
inserted reference to copy of the report, if any, filed
with the Health Care Financing Administration, and in
par. (3)(B) reorganized excluding provisions and, among
revisions, inserted salaries paid to employees for services.
Subsec. (b)(1). Pub. L. 97–35, § 948(c), inserted ‘‘responsible for management or administration’’ after ‘‘employee’’.
Subsec. (b)(4). Pub. L. 97–35, § 948(d), substituted
‘‘spouse, child, or parent’’ for ‘‘member of the immediate family’’.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–660 effective Oct. 1, 1985,
see section 815(a) of Pub. L. 99–660, set out as an Effective and Termination Dates of 1986 Amendment note
under section 300e–1 of this title.

§ 300f. Definitions
For purposes of this subchapter:
(1) The term ‘‘primary drinking water regulation’’ means a regulation which—
(A) applies to public water systems;
(B) specifies contaminants which, in the
judgment of the Administrator, may have
any adverse effect on the health of persons;
(C) specifies for each such contaminant either—
(i) a maximum contaminant level, if, in
the judgment of the Administrator, it is
economically and technologically feasible
to ascertain the level of such contaminant
in water in public water systems, or
(ii) if, in the judgment of the Administrator, it is not economically or technologically feasible to so ascertain the level
of such contaminant, each treatment technique known to the Administrator which
leads to a reduction in the level of such
contaminant sufficient to satisfy the requirements of section 300g–1 of this title;
and
(D) contains criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels; including accepted methods
for quality control and testing procedures to
insure compliance with such levels and to
insure proper operation and maintenance of
the system, and requirements as to (i) the
minimum quality of water which may be
taken into the system and (ii) siting for new
facilities for public water systems.
At any time after promulgation of a regulation referred to in this paragraph, the Administrator may add equally effective quality control and testing procedures by guidance published in the Federal Register. Such procedures shall be treated as an alternative for
public water systems to the quality control
and testing procedures listed in the regulation.
(2) The term ‘‘secondary drinking water regulation’’ means a regulation which applies to
public water systems and which specifies the
maximum contaminant levels which, in the
judgment of the Administrator, are requisite
to protect the public welfare. Such regulations
may apply to any contaminant in drinking
water (A) which may adversely affect the odor
or appearance of such water and consequently
may cause a substantial number of the persons
served by the public water system providing
such water to discontinue its use, or (B) which
may otherwise adversely affect the public welfare. Such regulations may vary according to
geographic and other circumstances.
(3) The term ‘‘maximum contaminant level’’
means the maximum permissible level of a
contaminant in water which is delivered to
any user of a public water system.
(4) PUBLIC WATER SYSTEM.—
(A) IN GENERAL.—The term ‘‘public water
system’’ means a system for the provision to

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

the public of water for human consumption
through pipes or other constructed conveyances, if such system has at least fifteen
service connections or regularly serves at
least twenty-five individuals. Such term includes (i) any collection, treatment, storage,
and distribution facilities under control of
the operator of such system and used primarily in connection with such system, and
(ii) any collection or pretreatment storage
facilities not under such control which are
used primarily in connection with such system.
(B) CONNECTIONS.—
(i) IN GENERAL.—For purposes of subparagraph (A), a connection to a system that
delivers water by a constructed conveyance other than a pipe shall not be considered a connection, if—
(I) the water is used exclusively for
purposes other than residential uses
(consisting of drinking, bathing, and
cooking, or other similar uses);
(II) the Administrator or the State (in
the case of a State exercising primary
enforcement responsibility for public
water systems) determines that alternative water to achieve the equivalent
level of public health protection provided by the applicable national primary
drinking water regulation is provided for
residential or similar uses for drinking
and cooking; or
(III) the Administrator or the State (in
the case of a State exercising primary
enforcement responsibility for public
water systems) determines that the
water provided for residential or similar
uses for drinking, cooking, and bathing
is centrally treated or treated at the
point of entry by the provider, a passthrough entity, or the user to achieve
the equivalent level of protection provided by the applicable national primary
drinking water regulations.
(ii) IRRIGATION DISTRICTS.—An irrigation
district in existence prior to May 18, 1994,
that provides primarily agricultural service through a piped water system with
only incidental residential or similar use
shall not be considered to be a public
water system if the system or the residential or similar users of the system comply
with subclause (II) or (III) of clause (i).

§ 300f

(6) The term ‘‘contaminant’’ means any
physical, chemical, biological, or radiological
substance or matter in water.
(7) The term ‘‘Administrator’’ means the Administrator of the Environmental Protection
Agency.
(8) The term ‘‘Agency’’ means the Environmental Protection Agency.
(9) The term ‘‘Council’’ means the National
Drinking Water Advisory Council established
under section 300j–5 of this title.
(10) The term ‘‘municipality’’ means a city,
town, or other public body created by or pursuant to State law, or an Indian Tribe.
(11) The term ‘‘Federal agency’’ means any
department, agency, or instrumentality of the
United States.
(12) The term ‘‘person’’ means an individual,
corporation, company, association, partnership, State, municipality, or Federal agency
(and includes officers, employees, and agents
of any corporation, company, association,
State, municipality, or Federal agency).
(13)(A) Except as provided in subparagraph
(B), the term ‘‘State’’ includes, in addition to
the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico,
the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.
(B) For purposes of section 300j–12 of this
title, the term ‘‘State’’ means each of the 50
States, the District of Columbia, and the Commonwealth of Puerto Rico.
(14) The term ‘‘Indian Tribe’’ means any Indian tribe having a Federally recognized governing body carrying out substantial governmental duties and powers over any area. For
purposes of section 300j–12 of this title, the
term includes any Native village (as defined in
section 1602(c) of title 43).
(15) COMMUNITY WATER SYSTEM.—The term
‘‘community water system’’ means a public
water system that—
(A) serves at least 15 service connections
used by year-round residents of the area
served by the system; or
(B) regularly serves at least 25 year-round
residents.
(16) NONCOMMUNITY WATER SYSTEM.—The
term ‘‘noncommunity water system’’ means a
public water system that is not a community
water system.
(July 1, 1944, ch. 373, title XIV, § 1401, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1660;
amended Pub. L. 94–317, title III, § 301(b)(2), June
23, 1976, 90 Stat. 707; Pub. L. 94–484, title IX,
§ 905(b)(1), Oct. 12, 1976, 90 Stat. 2325; Pub. L.
95–190, § 8(b), Nov. 16, 1977, 91 Stat. 1397; Pub. L.
99–339, title III, § 302(b), June 19, 1986, 100 Stat.
666; Pub. L. 104–182, title I, § 101(a), (b)(1), Aug. 6,
1996, 110 Stat. 1615, 1616.)

(C) TRANSITION PERIOD.—A water supplier
that would be a public water system only as
a result of modifications made to this paragraph by the Safe Drinking Water Act
Amendments of 1996 shall not be considered
a public water system for purposes of the
Act until the date that is two years after
August 6, 1996. If a water supplier does not
serve 15 service connections (as defined in
subparagraphs (A) and (B)) or 25 people at
any time after the conclusion of the 2-year
period, the water supplier shall not be considered a public water system.

The Safe Drinking Water Act Amendments of 1996, referred to in par. (4)(C), is Pub. L. 104–182, Aug. 6, 1996,
110 Stat. 1613. For complete classification of this Act to
the Code, see Short Title of 1996 Amendment note set
out under section 201 of this title and Tables.

(5) The term ‘‘supplier of water’’ means any
person who owns or operates a public water
system.

1996—Par. (1). Pub. L. 104–182, § 101(a)(1)(B), inserted
at end ‘‘At any time after promulgation of a regulation

REFERENCES IN TEXT

AMENDMENTS

§ 300f

TITLE 42—THE PUBLIC HEALTH AND WELFARE

referred to in this paragraph, the Administrator may
add equally effective quality control and testing procedures by guidance published in the Federal Register.
Such procedures shall be treated as an alternative for
public water systems to the quality control and testing
procedures listed in the regulation.’’
Par. (1)(D). Pub. L. 104–182, § 101(a)(1)(A), inserted ‘‘accepted methods for’’ before ‘‘quality control’’.
Par. (4). Pub. L. 104–182, § 101(b)(1), designated existing
provisions as subpar. (A), inserted par. and subpar.
headings, redesignated former subpars. (A) and (B) as
cls. (i) and (ii), respectively, substituted ‘‘water for
human consumption through pipes or other constructed
conveyances’’ for ‘‘piped water for human consumption’’ in first sentence, and added subpars. (B) and (C).
Par. (13). Pub. L. 104–182, § 101(a)(2), designated existing provisions as subpar. (A), substituted ‘‘Except as
provided in subparagraph (B), the term’’ for ‘‘The
term’’, and added subpar. (B).
Par. (14). Pub. L. 104–182, § 101(a)(3), inserted at end
‘‘For purposes of section 300j–12 of this title, the term
includes any Native village (as defined in section
1602(c) of title 43).’’
Pars. (15), (16). Pub. L. 104–182, § 101(a)(4), added pars.
(15) and (16).
1986—Par. (10). Pub. L. 99–339, § 302(b)(2), substituted
‘‘Indian Tribe’’ for ‘‘Indian tribal organization authorized by law’’.
Par. (14). Pub. L. 99–339, § 302(b)(1), added par. (14).
1977—Par. (12). Pub. L. 95–190 expanded definition of
‘‘person’’ to include Federal agency, and officers, employees, and agents of any corporation, company, etc.
1976—Par. (13). Pub. L. 94–484 defined ‘‘State’’ to include Northern Mariana Islands.
Pub. L. 94–317 added par. (13).
EFFECTIVE DATE OF 1996 AMENDMENT
Section 2(b) of Pub. L. 104–182 provided that: ‘‘Except
as otherwise specified in this Act [enacting sections
300g–7 to 300g–9, 300h–8, 300j–3c, and 300j–12 to 300j–18 of
this title and section 1263a of Title 33, Navigation and
Navigable Waters, amending this section, sections
300g–1 to 300g–6, 300h, 300h–5 to 300h–7, 300i, 300i–1, 300j
to 300j–2, 300j–4 to 300j–8, 300j–11, and 300j–21 to 300j–25 of
this title, sections 4701 and 4721 of Title 16, Conservation, and section 349 of Title 21, Food and Drugs, repealing section 13551 of this title, enacting provisions
set out as notes under this section, sections 201, 300g–1,
300j–1, and 300j–12 of this title, section 1281 of Title 33,
and section 45 of former Title 40, Public Buildings,
Property, and Works, and amending provisions set out
as a note under section 201 of this title] or in the
amendments made by this Act, this Act and the amendments made by this Act shall take effect on the date of
enactment of this Act [Aug. 6, 1996].’’
SHORT TITLE
This subchapter is known as the ‘‘Safe Drinking
Water Act’’, see note set out under section 201 of this
title.
TERMINATION OF TRUST TERRITORY OF THE PACIFIC
ISLANDS
For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title
48, Territories and Insular Possessions.
EFFECT OF PUBLIC LAW 104–182 ON FEDERAL WATER
POLLUTION CONTROL ACT
Section 2(c) of Pub. L. 104–182 provided that: ‘‘Except
for the provisions of section 302 [42 U.S.C. 300j–12 note]
(relating to transfers of funds), nothing in this Act [see
Effective Date of 1996 Amendment note above] or in any
amendments made by this Act to title XIV of the Public Health Service Act [this subchapter] (commonly
known as the ‘Safe Drinking Water Act’) or any other
law shall be construed by the Administrator of the Environmental Protection Agency or the courts as affecting, modifying, expanding, changing, or altering—

Page 966

‘‘(1) the provisions of the Federal Water Pollution
Control Act [33 U.S.C. 1251 et seq.];
‘‘(2) the duties and responsibilities of the Administrator under that Act; or
‘‘(3) the regulation or control of point or nonpoint
sources of pollution discharged into waters covered
by that Act.
The Administrator shall identify in the agency’s annual budget all funding and full-time equivalents administering such title XIV separately from funding and
staffing for the Federal Water Pollution Control Act.’’
CONGRESSIONAL FINDINGS
Section 3 of Pub. L. 104–182 provided that: ‘‘The Congress finds that—
‘‘(1) safe drinking water is essential to the protection of public health;
‘‘(2) because the requirements of the Safe Drinking
Water Act (42 U.S.C. 300f et seq.) now exceed the financial and technical capacity of some public water
systems, especially many small public water systems,
the Federal Government needs to provide assistance
to communities to help the communities meet Federal drinking water requirements;
‘‘(3) the Federal Government commits to maintaining and improving its partnership with the States in
the administration and implementation of the Safe
Drinking Water Act;
‘‘(4) States play a central role in the implementation of safe drinking water programs, and States need
increased financial resources and appropriate flexibility to ensure the prompt and effective development
and implementation of drinking water programs;
‘‘(5) the existing process for the assessment and selection of additional drinking water contaminants
needs to be revised and improved to ensure that there
is a sound scientific basis for setting priorities in establishing drinking water regulations;
‘‘(6) procedures for assessing the health effects of
contaminants establishing drinking water standards
should be revised to provide greater opportunity for
public education and participation;
‘‘(7) in considering the appropriate level of regulation for contaminants in drinking water, risk assessment, based on sound and objective science, and benefit-cost analysis are important analytical tools for
improving the efficiency and effectiveness of drinking
water regulations to protect human health;
‘‘(8) more effective protection of public health requires—
‘‘(A) a Federal commitment to set priorities that
will allow scarce Federal, State, and local resources
to be targeted toward the drinking water problems
of greatest public health concern;
‘‘(B) maximizing the value of the different and
complementary strengths and responsibilities of
the Federal and State governments in those States
that have primary enforcement responsibility for
the Safe Drinking Water Act; and
‘‘(C) prevention of drinking water contamination
through well-trained system operators, water systems with adequate managerial, technical, and financial capacity, and enhanced protection of source
waters of public water systems;
‘‘(9) compliance with the requirements of the Safe
Drinking Water Act continues to be a concern at public water systems experiencing technical and financial limitations, and Federal, State, and local governments need more resources and more effective authority to attain the objectives of the Safe Drinking
Water Act; and
‘‘(10) consumers served by public water systems
should be provided with information on the source of
the water they are drinking and its quality and safety, as well as prompt notification of any violation of
drinking water regulations.’’
GAO STUDY
Pub. L. 104–182, title I, § 101(b)(2), Aug. 6, 1996, 110
Stat. 1617, provided that: ‘‘The Comptroller General of
the United States shall undertake a study to—

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(A) ascertain the numbers and locations of individuals and households relying for their residential
water needs, including drinking, bathing, and cooking (or other similar uses) on irrigation water systems, mining water systems, industrial water systems, or other water systems covered by section
1401(4)(B) of the Safe Drinking Water Act [par. (4)(B)
of this section] that are not public water systems
subject to the Safe Drinking Water Act [this subchapter];
‘‘(B) determine the sources and costs and affordability (to users and systems) of water used by such
populations for their residential water needs; and
‘‘(C) review State and water system compliance
with the exclusion provisions of section 1401(4)(B) of
such Act.
The Comptroller General shall submit a report to the
Congress within 3 years after the date of enactment of
this Act [Aug. 6, 1996] containing the results of such
study.’’
SAFE DRINKING WATER AMENDMENTS OF 1977
RESTRICTIONS ON APPROPRIATIONS FOR RESEARCH
Pub. L. 95–190, § 2(e), Nov. 16, 1977, 91 Stat. 1393, provided that: ‘‘Nothing in this Act [see Short Title of 1977
Amendment note set out under section 201 of this title]
shall be construed to authorize the appropriation of
any amount for research under title XIV of the Public
Health Service Act [this subchapter] (relating to safe
drinking water).’’
SAFE DRINKING WATER AMENDMENTS OF 1977 AS NOT
AFFECTING AUTHORITY OF ADMINISTRATOR WITH RESPECT TO CONTAMINANTS
Pub. L. 95–190, § 3(e)(2), Nov. 16, 1977, 91 Stat. 1394, provided that: ‘‘Nothing in this Act [see Short Title of 1977
Amendment note set out under section 201 of this title]
shall be construed to alter or affect the Administrator’s authority or duty under title 14 of the Public
Health Service Act [this subchapter] to promulgate
regulations or take other action with respect to any
contaminant.’’
RURAL WATER SURVEY; REPORT TO PRESIDENT AND
CONGRESS; AUTHORIZATION OF APPROPRIATIONS
Section 3 of Pub. L. 93–523, as amended by Pub. L.
95–190, §§ 2(d), 3(d), Nov. 16, 1977, 91 Stat. 1393, 1394, directed Administrator of Environmental Protection
Agency, after consultation with Secretary of Agriculture and the several States, to enter into arrangements with public or private entities to conduct a survey of quantity, quality, and availability of rural
drinking water supplies, which survey was to include,
but not be limited to, consideration of number of residents in each rural area who presently are being inadequately served by a public or private drinking water
supply system, or by an individual home drinking
water supply system, or who presently have limited or
otherwise inadequate access to drinking water, or who,
due to absence or inadequacy of a drinking water supply system, are exposed to an increased health hazard,
and who have experienced incidents of chronic or acute
illness, which may be attributed to inadequacy of a
drinking water supply system. Survey to be completed
within eighteen months of Dec. 16, 1974, and a final report thereon submitted, not later than six months after
completion of survey, to President and to Congress.
FEDERAL COMPLIANCE WITH POLLUTION CONTROL
STANDARDS
For provisions relating to the responsibility of the
head of each Executive agency for compliance with applicable pollution control standards, see Ex. Ord. No.
12088, Oct. 13, 1978, 43 F.R. 47707, set out as a note under
section 4321 of this title.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an

§ 300g–1

advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

PART B—PUBLIC WATER SYSTEMS
§ 300g. Coverage
Subject to sections 300g–4 and 300g–5 of this
title, national primary drinking water regulations under this part shall apply to each public
water system in each State; except that such
regulations shall not apply to a public water
system—
(1) which consists only of distribution and
storage facilities (and does not have any collection and treatment facilities);
(2) which obtains all of its water from, but is
not owned or operated by, a public water system to which such regulations apply;
(3) which does not sell water to any person;
and
(4) which is not a carrier which conveys passengers in interstate commerce.
(July 1, 1944, ch. 373, title XIV, § 1411, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1662.)
§ 300g–1. National drinking water regulations
(a) National primary drinking water regulations;
maximum contaminant level goals; simultaneous publication of regulations and goals
(1) Effective on June 19, 1986, each national interim or revised primary drinking water regulation promulgated under this section before June
19, 1986, shall be deemed to be a national primary drinking water regulation under subsection (b) of this section. No such regulation
shall be required to comply with the standards
set forth in subsection (b)(4) of this section unless such regulation is amended to establish a
different maximum contaminant level after
June 19, 1986.
(2) After June 19, 1986, each recommended
maximum contaminant level published before
June 19, 1986, shall be treated as a maximum
contaminant level goal.
(3) Whenever a national primary drinking
water regulation is proposed under subsection
(b) of this section for any contaminant, the
maximum contaminant level goal for such contaminant shall be proposed simultaneously.
Whenever a national primary drinking water
regulation is promulgated under subsection (b)
of this section for any contaminant, the maximum contaminant level goal for such contaminant shall be published simultaneously.
(4) Paragraph (3) shall not apply to any recommended maximum contaminant level published before June 19, 1986.
(b) Standards
(1) IDENTIFICATION OF CONTAMINANTS FOR LISTING.—
(A) GENERAL AUTHORITY.—The Administrator
shall, in accordance with the procedures established by this subsection, publish a maximum
contaminant level goal and promulgate a national primary drinking water regulation for a
contaminant (other than a contaminant referred to in paragraph (2) for which a national
primary drinking water regulation has been

§ 300g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

promulgated as of August 6, 1996) if the Administrator determines that—
(i) the contaminant may have an adverse
effect on the health of persons;
(ii) the contaminant is known to occur or
there is a substantial likelihood that the
contaminant will occur in public water systems with a frequency and at levels of public
health concern; and
(iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health
risk reduction for persons served by public
water systems.
(B) REGULATION OF UNREGULATED CONTAMINANTS.—
(i) LISTING OF CONTAMINANTS FOR CONSIDERATION.—(I) Not later than 18 months after
August 6, 1996, and every 5 years thereafter,
the Administrator, after consultation with
the scientific community, including the
Science Advisory Board, after notice and opportunity for public comment, and after considering the occurrence data base established under section 300j–4(g) of this title,
shall publish a list of contaminants which,
at the time of publication, are not subject to
any proposed or promulgated national primary drinking water regulation, which are
known or anticipated to occur in public
water systems, and which may require regulation under this subchapter.
(II) The unregulated contaminants considered under subclause (I) shall include, but
not be limited to, substances referred to in
section 9601(14) of this title, and substances
registered as pesticides under the Federal
Insecticide, Fungicide, and Rodenticide Act
[7 U.S.C. 136 et seq.].
(III) The Administrator’s decision whether
or not to select an unregulated contaminant
for a list under this clause shall not be subject to judicial review.
(ii) DETERMINATION TO REGULATE.—(I) Not
later than 5 years after August 6, 1996, and
every 5 years thereafter, the Administrator
shall, after notice of the preliminary determination and opportunity for public comment, for not fewer than 5 contaminants included on the list published under clause (i),
make determinations of whether or not to
regulate such contaminants.
(II) A determination to regulate a contaminant shall be based on findings that the
criteria of clauses (i), (ii), and (iii) of subparagraph (A) are satisfied. Such findings
shall be based on the best available public
health information, including the occurrence data base established under section
300j–4(g) of this title.
(III) The Administrator may make a determination to regulate a contaminant that
does not appear on a list under clause (i) if
the determination to regulate is made pursuant to subclause (II).
(IV) A determination under this clause not
to regulate a contaminant shall be considered final agency action and subject to judicial review.
(iii) REVIEW.—Each document setting forth
the determination for a contaminant under

Page 968

clause (ii) shall be available for public comment at such time as the determination is
published.
(C) PRIORITIES.—In selecting unregulated
contaminants for consideration under subparagraph (B), the Administrator shall select
contaminants that present the greatest public
health concern. The Administrator, in making
such selection, shall take into consideration,
among other factors of public health concern,
the effect of such contaminants upon subgroups that comprise a meaningful portion of
the general population (such as infants, children, pregnant women, the elderly, individuals
with a history of serious illness, or other subpopulations) that are identifiable as being at
greater risk of adverse health effects due to
exposure to contaminants in drinking water
than the general population.
(D) URGENT THREATS TO PUBLIC HEALTH.—The
Administrator may promulgate an interim national primary drinking water regulation for a
contaminant without making a determination
for the contaminant under paragraph (4)(C), or
completing the analysis under paragraph
(3)(C), to address an urgent threat to public
health as determined by the Administrator
after consultation with and written response
to any comments provided by the Secretary of
Health and Human Services, acting through
the director of the Centers for Disease Control
and Prevention or the director of the National
Institutes of Health. A determination for any
contaminant in accordance with paragraph
(4)(C) subject to an interim regulation under
this subparagraph shall be issued, and a completed analysis meeting the requirements of
paragraph (3)(C) shall be published, not later
than 3 years after the date on which the regulation is promulgated and the regulation shall
be repromulgated, or revised if appropriate,
not later than 5 years after that date.
(E) REGULATION.—For each contaminant
that the Administrator determines to regulate
under subparagraph (B), the Administrator
shall publish maximum contaminant level
goals and promulgate, by rule, national primary drinking water regulations under this
subsection. The Administrator shall propose
the maximum contaminant level goal and national primary drinking water regulation for a
contaminant not later than 24 months after
the determination to regulate under subparagraph (B), and may publish such proposed regulation concurrent with the determination to
regulate. The Administrator shall publish a
maximum contaminant level goal and promulgate a national primary drinking water regulation within 18 months after the proposal
thereof. The Administrator, by notice in the
Federal Register, may extend the deadline for
such promulgation for up to 9 months.
(F) HEALTH ADVISORIES AND OTHER ACTIONS.—
The Administrator may publish health advisories (which are not regulations) or take
other appropriate actions for contaminants
not subject to any national primary drinking
water regulation.
(2) SCHEDULES AND DEADLINES.—
(A) IN GENERAL.—In the case of the contaminants listed in the Advance Notice of Proposed

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Rulemaking published in volume 47, Federal
Register, page 9352, and in volume 48, Federal
Register, page 45502, the Administrator shall
publish maximum contaminant level goals and
promulgate national primary drinking water
regulations—
(i) not later than 1 year after June 19, 1986,
for not fewer than 9 of the listed contaminants;
(ii) not later than 2 years after June 19,
1986, for not fewer than 40 of the listed contaminants; and
(iii) not later than 3 years after June 19,
1986, for the remainder of the listed contaminants.
(B) SUBSTITUTION OF CONTAMINANTS.—If the
Administrator identifies a drinking water contaminant the regulation of which, in the judgment of the Administrator, is more likely to
be protective of public health (taking into account the schedule for regulation under subparagraph (A)) than a contaminant referred to
in subparagraph (A), the Administrator may
publish a maximum contaminant level goal
and promulgate a national primary drinking
water regulation for the identified contaminant in lieu of regulating the contaminant referred to in subparagraph (A). Substitutions
may be made for not more than 7 contaminants referred to in subparagraph (A). Regulation of a contaminant identified under this
subparagraph shall be in accordance with the
schedule applicable to the contaminant for
which the substitution is made.
(C) DISINFECTANTS AND DISINFECTION BYPRODUCTS.—The Administrator shall promulgate an
Interim Enhanced Surface Water Treatment
Rule, a Final Enhanced Surface Water Treatment Rule, a Stage I Disinfectants and Disinfection Byproducts Rule, and a Stage II Disinfectants and Disinfection Byproducts Rule
in accordance with the schedule published in
volume 59, Federal Register, page 6361 (February 10, 1994), in table III.13 of the proposed
Information Collection Rule. If a delay occurs
with respect to the promulgation of any rule
in the schedule referred to in this subparagraph, all subsequent rules shall be completed
as expeditiously as practicable but no later
than a revised date that reflects the interval
or intervals for the rules in the schedule.
(3) RISK ASSESSMENT, MANAGEMENT, AND COMMUNICATION.—
(A) USE OF SCIENCE IN DECISIONMAKING.—In
carrying out this section, and, to the degree
that an Agency action is based on science, the
Administrator shall use—
(i) the best available, peer-reviewed
science and supporting studies conducted in
accordance with sound and objective scientific practices; and
(ii) data collected by accepted methods or
best available methods (if the reliability of
the method and the nature of the decision
justifies use of the data).
(B) PUBLIC INFORMATION.—In carrying out
this section, the Administrator shall ensure
that the presentation of information on public
health effects is comprehensive, informative,
and understandable. The Administrator shall,

§ 300g–1

in a document made available to the public in
support of a regulation promulgated under
this section, specify, to the extent practicable—
(i) each population addressed by any estimate of public health effects;
(ii) the expected risk or central estimate
of risk for the specific populations;
(iii) each appropriate upper-bound or
lower-bound estimate of risk;
(iv) each significant uncertainty identified
in the process of the assessment of public
health effects and studies that would assist
in resolving the uncertainty; and
(v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of
public health effects and the methodology
used to reconcile inconsistencies in the scientific data.
(C) HEALTH RISK REDUCTION AND COST ANALYSIS.—

(i) MAXIMUM CONTAMINANT LEVELS.—When
proposing any national primary drinking
water regulation that includes a maximum
contaminant level, the Administrator shall,
with respect to a maximum contaminant
level that is being considered in accordance
with paragraph (4) and each alternative
maximum contaminant level that is being
considered pursuant to paragraph (5) or
(6)(A), publish, seek public comment on, and
use for the purposes of paragraphs (4), (5),
and (6) an analysis of each of the following:
(I) Quantifiable and nonquantifiable
health risk reduction benefits for which
there is a factual basis in the rulemaking
record to conclude that such benefits are
likely to occur as the result of treatment
to comply with each level.
(II) Quantifiable and nonquantifiable
health risk reduction benefits for which
there is a factual basis in the rulemaking
record to conclude that such benefits are
likely to occur from reductions in co-occurring contaminants that may be attributed solely to compliance with the maximum contaminant level, excluding benefits resulting from compliance with other
proposed or promulgated regulations.
(III) Quantifiable and nonquantifiable
costs for which there is a factual basis in
the rulemaking record to conclude that
such costs are likely to occur solely as a
result of compliance with the maximum
contaminant level, including monitoring,
treatment, and other costs and excluding
costs resulting from compliance with
other proposed or promulgated regulations.
(IV) The incremental costs and benefits
associated with each alternative maximum
contaminant level considered.
(V) The effects of the contaminant on
the general population and on groups within the general population such as infants,
children, pregnant women, the elderly, individuals with a history of serious illness,
or other subpopulations that are identified
as likely to be at greater risk of adverse
health effects due to exposure to contami-

§ 300g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

nants in drinking water than the general
population.
(VI) Any increased health risk that may
occur as the result of compliance, including risks associated with co-occurring contaminants.
(VII) Other relevant factors, including
the quality and extent of the information,
the uncertainties in the analysis supporting subclauses (I) through (VI), and factors
with respect to the degree and nature of
the risk.
(ii) TREATMENT TECHNIQUES.—When proposing a national primary drinking water regulation that includes a treatment technique
in accordance with paragraph (7)(A), the Administrator shall publish and seek public
comment on an analysis of the health risk
reduction benefits and costs likely to be experienced as the result of compliance with
the treatment technique and alternative
treatment techniques that are being considered, taking into account, as appropriate,
the factors described in clause (i).
(iii) APPROACHES TO MEASURE AND VALUE
BENEFITS.—The Administrator may identify
valid approaches for the measurement and
valuation of benefits under this subparagraph, including approaches to identify consumer willingness to pay for reductions in
health risks from drinking water contaminants.
(iv) AUTHORIZATION.—There are authorized
to be appropriated to the Administrator,
acting through the Office of Ground Water
and Drinking Water, to conduct studies, assessments, and analyses in support of regulations or the development of methods,
$35,000,000 for each of fiscal years 1996
through 2003.
(4) GOALS AND STANDARDS.—
(A) MAXIMUM CONTAMINANT LEVEL GOALS.—
Each maximum contaminant level goal established under this subsection shall be set at the
level at which no known or anticipated adverse effects on the health of persons occur
and which allows an adequate margin of safety.
(B) MAXIMUM CONTAMINANT LEVELS.—Except
as provided in paragraphs (5) and (6), each national primary drinking water regulation for a
contaminant for which a maximum contaminant level goal is established under this subsection shall specify a maximum contaminant
level for such contaminant which is as close to
the maximum contaminant level goal as is
feasible.
(C) DETERMINATION.—At the time the Administrator proposes a national primary drinking
water regulation under this paragraph, the Administrator shall publish a determination as
to whether the benefits of the maximum contaminant level justify, or do not justify, the
costs based on the analysis conducted under
paragraph (3)(C).
(D) DEFINITION OF FEASIBLE.—For the purposes of this subsection, the term ‘‘feasible’’
means feasible with the use of the best technology, treatment techniques and other means
which the Administrator finds, after examina-

Page 970

tion for efficacy under field conditions and not
solely under laboratory conditions, are available (taking cost into consideration). For the
purpose of this paragraph, granular activated
carbon is feasible for the control of synthetic
organic chemicals, and any technology, treatment technique, or other means found to be
the best available for the control of synthetic
organic chemicals must be at least as effective
in controlling synthetic organic chemicals as
granular activated carbon.
(E) FEASIBLE TECHNOLOGIES.—
(i) IN GENERAL.—Each national primary
drinking water regulation which establishes
a maximum contaminant level shall list the
technology, treatment techniques, and other
means which the Administrator finds to be
feasible for purposes of meeting such maximum contaminant level, but a regulation
under this subsection shall not require that
any specified technology, treatment technique, or other means be used for purposes of
meeting such maximum contaminant level.
(ii) LIST OF TECHNOLOGIES FOR SMALL SYSTEMS.—The Administrator shall include in
the list any technology, treatment technique, or other means that is affordable, as
determined by the Administrator in consultation with the States, for small public
water systems serving—
(I) a population of 10,000 or fewer but
more than 3,300;
(II) a population of 3,300 or fewer but
more than 500; and
(III) a population of 500 or fewer but
more than 25;
and that achieves compliance with the maximum contaminant level or treatment technique, including packaged or modular systems and point-of-entry or point-of-use
treatment units. Point-of-entry and pointof-use treatment units shall be owned, controlled and maintained by the public water
system or by a person under contract with
the public water system to ensure proper operation and maintenance and compliance
with the maximum contaminant level or
treatment technique and equipped with mechanical warnings to ensure that customers
are automatically notified of operational
problems. The Administrator shall not include in the list any point-of-use treatment
technology, treatment technique, or other
means to achieve compliance with a maximum contaminant level or treatment technique requirement for a microbial contaminant (or an indicator of a microbial contaminant). If the American National Standards Institute has issued product standards
applicable to a specific type of point-ofentry or point-of-use treatment unit, individual units of that type shall not be accepted for compliance with a maximum contaminant level or treatment technique requirement unless they are independently certified
in accordance with such standards. In listing
any technology, treatment technique, or
other means pursuant to this clause, the Administrator shall consider the quality of the
source water to be treated.
(iii) LIST OF TECHNOLOGIES THAT ACHIEVE
COMPLIANCE.—Except as provided in clause

Page 971

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(v), not later than 2 years after August 6,
1996, and after consultation with the States,
the Administrator shall issue a list of technologies that achieve compliance with the
maximum contaminant level or treatment
technique for each category of public water
systems described in subclauses (I), (II), and
(III) of clause (ii) for each national primary
drinking water regulation promulgated prior
to June 19, 1986.
(iv) ADDITIONAL TECHNOLOGIES.—The Administrator may, at any time after a national primary drinking water regulation
has been promulgated, supplement the list of
technologies describing additional or new or
innovative treatment technologies that
meet the requirements of this paragraph for
categories of small public water systems described in subclauses (I), (II), and (III) of
clause (ii) that are subject to the regulation.
(v) TECHNOLOGIES THAT MEET SURFACE
WATER TREATMENT RULE.—Within one year
after August 6, 1996, the Administrator shall
list technologies that meet the Surface
Water Treatment Rule for each category of
public water systems described in subclauses
(I), (II), and (III) of clause (ii).
(5) ADDITIONAL HEALTH RISK CONSIDERATIONS.—
(A) IN GENERAL.—Notwithstanding paragraph
(4), the Administrator may establish a maximum contaminant level for a contaminant at
a level other than the feasible level, if the
technology, treatment techniques, and other
means used to determine the feasible level
would result in an increase in the health risk
from drinking water by—
(i) increasing the concentration of other
contaminants in drinking water; or
(ii) interfering with the efficacy of drinking water treatment techniques or processes
that are used to comply with other national
primary drinking water regulations.
(B) ESTABLISHMENT OF LEVEL.—If the Administrator establishes a maximum contaminant
level or levels or requires the use of treatment
techniques for any contaminant or contaminants pursuant to the authority of this paragraph—
(i) the level or levels or treatment techniques shall minimize the overall risk of adverse health effects by balancing the risk
from the contaminant and the risk from
other contaminants the concentrations of
which may be affected by the use of a treatment technique or process that would be employed to attain the maximum contaminant
level or levels; and
(ii) the combination of technology, treatment techniques, or other means required to
meet the level or levels shall not be more
stringent than is feasible (as defined in paragraph (4)(D)).
(6) ADDITIONAL HEALTH RISK REDUCTION AND
COST CONSIDERATIONS.—
(A) IN GENERAL.—Notwithstanding paragraph
(4), if the Administrator determines based on
an analysis conducted under paragraph (3)(C)
that the benefits of a maximum contaminant
level promulgated in accordance with paragraph (4) would not justify the costs of com-

§ 300g–1

plying with the level, the Administrator may,
after notice and opportunity for public comment, promulgate a maximum contaminant
level for the contaminant that maximizes
health risk reduction benefits at a cost that is
justified by the benefits.
(B) EXCEPTION.—The Administrator shall not
use the authority of this paragraph to promulgate a maximum contaminant level for a contaminant, if the benefits of compliance with a
national primary drinking water regulation
for the contaminant that would be promulgated in accordance with paragraph (4) experienced by—
(i) persons served by large public water
systems; and
(ii) persons served by such other systems
as are unlikely, based on information provided by the States, to receive a variance
under section 300g–4(e) of this title (relating
to small system variances);
would justify the costs to the systems of complying with the regulation. This subparagraph
shall not apply if the contaminant is found almost exclusively in small systems eligible
under section 300g–4(e) of this title for a small
system variance.
(C) DISINFECTANTS AND DISINFECTION BYPRODUCTS.—The Administrator may not use the authority of this paragraph to establish a maximum contaminant level in a Stage I or Stage
II national primary drinking water regulation
(as described in paragraph (2)(C)) for contaminants that are disinfectants or disinfection byproducts, or to establish a maximum contaminant level or treatment technique requirement for the control of cryptosporidium. The
authority of this paragraph may be used to establish regulations for the use of disinfection
by systems relying on ground water sources as
required by paragraph (8).
(D) JUDICIAL REVIEW.—A determination by
the Administrator that the benefits of a maximum contaminant level or treatment requirement justify or do not justify the costs of complying with the level shall be reviewed by the
court pursuant to section 300j–7 of this title
only as part of a review of a final national primary drinking water regulation that has been
promulgated based on the determination and
shall not be set aside by the court under that
section unless the court finds that the determination is arbitrary and capricious.
(7)(A) The Administrator is authorized to promulgate a national primary drinking water regulation that requires the use of a treatment
technique in lieu of establishing a maximum
contaminant level, if the Administrator makes a
finding that it is not economically or technologically feasible to ascertain the level of the
contaminant. In such case, the Administrator
shall identify those treatment techniques which,
in the Administrator’s judgment, would prevent
known or anticipated adverse effects on the
health of persons to the extent feasible. Such
regulations shall specify each treatment technique known to the Administrator which meets
the requirements of this paragraph, but the Administrator may grant a variance from any
specified treatment technique in accordance
with section 300g–4(a)(3) of this title.

§ 300g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Any schedule referred to in this subsection
for the promulgation of a national primary
drinking water regulation for any contaminant
shall apply in the same manner if the regulation
requires a treatment technique in lieu of establishing a maximum contaminant level.
(C)(i) Not later than 18 months after June 19,
1986, the Administrator shall propose and promulgate national primary drinking water regulations specifying criteria under which filtration
(including coagulation and sedimentation, as appropriate) is required as a treatment technique
for public water systems supplied by surface
water sources. In promulgating such rules, the
Administrator shall consider the quality of
source waters, protection afforded by watershed
management, treatment practices (such as disinfection and length of water storage) and other
factors relevant to protection of health.
(ii) In lieu of the provisions of section 300g–4 of
this title the Administrator shall specify procedures by which the State determines which public water systems within its jurisdiction shall
adopt filtration under the criteria of clause (i).
The State may require the public water system
to provide studies or other information to assist
in this determination. The procedures shall provide notice and opportunity for public hearing
on this determination. If the State determines
that filtration is required, the State shall prescribe a schedule for compliance by the public
water system with the filtration requirement. A
schedule shall require compliance within 18
months of a determination made under clause
(iii).
(iii) Within 18 months from the time that the
Administrator establishes the criteria and procedures under this subparagraph, a State with
primary enforcement responsibility shall adopt
any necessary regulations to implement this
subparagraph. Within 12 months of adoption of
such regulations the State shall make determinations regarding filtration for all the public
water systems within its jurisdiction supplied
by surface waters.
(iv) If a State does not have primary enforcement responsibility for public water systems,
the Administrator shall have the same authority to make the determination in clause (ii) in
such State as the State would have under that
clause. Any filtration requirement or schedule
under this subparagraph shall be treated as if it
were a requirement of a national primary drinking water regulation.
(v) As an additional alternative to the regulations promulgated pursuant to clauses (i) and
(iii), including the criteria for avoiding filtration contained in 40 CFR 141.71, a State exercising primary enforcement responsibility for public water systems may, on a case-by-case basis,
and after notice and opportunity for public comment, establish treatment requirements as an
alternative to filtration in the case of systems
having uninhabited, undeveloped watersheds in
consolidated ownership, and having control over
access to, and activities in, those watersheds, if
the State determines (and the Administrator
concurs) that the quality of the source water
and the alternative treatment requirements established by the State ensure greater removal or
inactivation efficiencies of pathogenic orga-

Page 972

nisms for which national primary drinking
water regulations have been promulgated or
that are of public health concern than would be
achieved by the combination of filtration and
chlorine disinfection (in compliance with this
section).
(8) DISINFECTION.—At any time after the end of
the 3-year period that begins on August 6, 1996,
but not later than the date on which the Administrator promulgates a Stage II rulemaking for
disinfectants and disinfection byproducts (as described in paragraph (2)(C)), the Administrator
shall also promulgate national primary drinking
water regulations requiring disinfection as a
treatment technique for all public water systems, including surface water systems and, as
necessary, ground water systems. After consultation with the States, the Administrator
shall (as part of the regulations) promulgate criteria that the Administrator, or a State that
has primary enforcement responsibility under
section 300g–2 of this title, shall apply to determine whether disinfection shall be required as a
treatment technique for any public water system served by ground water. The Administrator
shall simultaneously promulgate a rule specifying criteria that will be used by the Administrator (or delegated State authorities) to grant
variances from this requirement according to
the provisions of sections 300g–4(a)(1)(B) and
300g–4(a)(3) of this title. In implementing section
300j–1(e) of this title the Administrator or the
delegated State authority shall, where appropriate, give special consideration to providing
technical assistance to small public water systems in complying with the regulations promulgated under this paragraph.
(9) REVIEW AND REVISION.—The Administrator
shall, not less often than every 6 years, review
and revise, as appropriate, each national primary drinking water regulation promulgated
under this subchapter. Any revision of a national primary drinking water regulation shall
be promulgated in accordance with this section,
except that each revision shall maintain, or provide for greater, protection of the health of persons.
(10) EFFECTIVE DATE.—A national primary
drinking water regulation promulgated under
this section (and any amendment thereto) shall
take effect on the date that is 3 years after the
date on which the regulation is promulgated unless the Administrator determines that an earlier date is practicable, except that the Administrator, or a State (in the case of an individual
system), may allow up to 2 additional years to
comply with a maximum contaminant level or
treatment technique if the Administrator or
State (in the case of an individual system) determines that additional time is necessary for
capital improvements.
(11) No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.
(12) CERTAIN CONTAMINANTS.—
(A) ARSENIC.—
(i) SCHEDULE AND STANDARD.—Notwithstanding the deadlines set forth in paragraph
(1), the Administrator shall promulgate a
national primary drinking water regulation

Page 973

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for arsenic pursuant to this subsection, in
accordance with the schedule established by
this paragraph.
(ii) STUDY PLAN.—Not later than 180 days
after August 6, 1996, the Administrator shall
develop a comprehensive plan for study in
support of drinking water rulemaking to reduce the uncertainty in assessing health
risks associated with exposure to low levels
of arsenic. In conducting such study, the Administrator shall consult with the National
Academy of Sciences, other Federal agencies, and interested public and private entities.
(iii) COOPERATIVE AGREEMENTS.—In carrying out the study plan, the Administrator
may enter into cooperative agreements with
other Federal agencies, State and local governments, and other interested public and
private entities.
(iv) PROPOSED REGULATIONS.—The Administrator shall propose a national primary
drinking water regulation for arsenic not
later than January 1, 2000.
(v) FINAL REGULATIONS.—Not later than
January 1, 2001, after notice and opportunity
for public comment, the Administrator shall
promulgate a national primary drinking
water regulation for arsenic.
(vi) AUTHORIZATION.—There are authorized
to be appropriated $2,500,000 for each of fiscal
years 1997 through 2000 for the studies required by this paragraph.
(B) SULFATE.—
(i) ADDITIONAL STUDY.—Prior to promulgating a national primary drinking water
regulation for sulfate, the Administrator
and the Director of the Centers for Disease
Control and Prevention shall jointly conduct
an additional study to establish a reliable
dose-response relationship for the adverse
human health effects that may result from
exposure to sulfate in drinking water, including the health effects that may be experienced by groups within the general population (including infants and travelers) that
are potentially at greater risk of adverse
health effects as the result of such exposure.
The study shall be conducted in consultation
with interested States, shall be based on the
best available, peer-reviewed science and
supporting studies conducted in accordance
with sound and objective scientific practices, and shall be completed not later than
30 months after August 6, 1996.
(ii) DETERMINATION.—The Administrator
shall include sulfate among the 5 or more
contaminants for which a determination is
made pursuant to paragraph (3)(B) not later
than 5 years after August 6, 1996.
(iii) PROPOSED AND FINAL RULE.—Notwithstanding the deadlines set forth in paragraph
(2), the Administrator may, pursuant to the
authorities of this subsection and after notice and opportunity for public comment,
promulgate a final national primary drinking water regulation for sulfate. Any such
regulation shall include requirements for
public notification and options for the provision of alternative water supplies to populations at risk as a means of complying with

§ 300g–1

the regulation in lieu of a best available
treatment technology or other means.
(13) RADON IN DRINKING WATER.—
(A) NATIONAL PRIMARY DRINKING WATER REGULATION.—Notwithstanding paragraph (2), the
Administrator shall withdraw any national
primary drinking water regulation for radon
proposed prior to August 6, 1996, and shall propose and promulgate a regulation for radon
under this section, as amended by the Safe
Drinking Water Act Amendments of 1996.
(B) RISK ASSESSMENT AND STUDIES.—
(i) ASSESSMENT BY NAS.—Prior to proposing a national primary drinking water regulation for radon, the Administrator shall arrange for the National Academy of Sciences
to prepare a risk assessment for radon in
drinking water using the best available
science in accordance with the requirements
of paragraph (3). The risk assessment shall
consider each of the risks associated with
exposure to radon from drinking water and
consider studies on the health effects of
radon at levels and under conditions likely
to be experienced through residential exposure. The risk assessment shall be peer-reviewed.
(ii) STUDY OF OTHER MEASURES.—The Administrator shall arrange for the National
Academy of Sciences to prepare an assessment of the health risk reduction benefits
associated with various mitigation measures
to reduce radon levels in indoor air. The assessment may be conducted as part of the
risk assessment authorized by clause (i) and
shall be used by the Administrator to prepare the guidance and approve State programs under subparagraph (G).
(iii) OTHER ORGANIZATION.—If the National
Academy of Sciences declines to prepare the
risk assessment or studies required by this
subparagraph, the Administrator shall enter
into a contract or cooperative agreement
with another independent, scientific organization to prepare such assessments or studies.
(C) HEALTH RISK REDUCTION AND COST ANALYSIS.—Not later than 30 months after August 6,
1996, the Administrator shall publish, and seek
public comment on, a health risk reduction
and cost analysis meeting the requirements of
paragraph (3)(C) for potential maximum contaminant levels that are being considered for
radon in drinking water. The Administrator
shall include a response to all significant public comments received on the analysis with
the preamble for the proposed rule published
under subparagraph (D).
(D) PROPOSED REGULATION.—Not later than
36 months after August 6, 1996, the Administrator shall propose a maximum contaminant
level goal and a national primary drinking
water regulation for radon pursuant to this
section.
(E) FINAL REGULATION.—Not later than 12
months after the date of the proposal under
subparagraph (D), the Administrator shall
publish a maximum contaminant level goal
and promulgate a national primary drinking
water regulation for radon pursuant to this

§ 300g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section based on the risk assessment prepared
pursuant to subparagraph (B) and the health
risk reduction and cost analysis published pursuant to subparagraph (C). In considering the
risk assessment and the health risk reduction
and cost analysis in connection with the promulgation of such a standard, the Administrator shall take into account the costs and
benefits of control programs for radon from
other sources.
(F) ALTERNATIVE MAXIMUM CONTAMINANT
LEVEL.—If the maximum contaminant level
for radon in drinking water promulgated pursuant to subparagraph (E) is more stringent
than necessary to reduce the contribution to
radon in indoor air from drinking water to a
concentration that is equivalent to the national average concentration of radon in outdoor air, the Administrator shall, simultaneously with the promulgation of such level,
promulgate an alternative maximum contaminant level for radon that would result in a
contribution of radon from drinking water to
radon levels in indoor air equivalent to the national average concentration of radon in outdoor air. If the Administrator promulgates an
alternative maximum contaminant level
under this subparagraph, the Administrator
shall, after notice and opportunity for public
comment and in consultation with the States,
publish guidelines for State programs, including criteria for multimedia measures to mitigate radon levels in indoor air, to be used by
the States in preparing programs under subparagraph (G). The guidelines shall take into
account data from existing radon mitigation
programs and the assessment of mitigation
measures prepared under subparagraph (B).
(G) MULTIMEDIA RADON MITIGATION PROGRAMS.—
(i) IN GENERAL.—A State may develop and
submit a multimedia program to mitigate
radon levels in indoor air for approval by the
Administrator under this subparagraph. If,
after notice and the opportunity for public
comment, such program is approved by the
Administrator, public water systems in the
State may comply with the alternative maximum contaminant level promulgated under
subparagraph (F) in lieu of the maximum
contaminant level in the national primary
drinking water regulation promulgated
under subparagraph (E).
(ii) ELEMENTS OF PROGRAMS.—State programs may rely on a variety of mitigation
measures including public education, testing, training, technical assistance, remediation grant and loan or incentive programs,
or other regulatory or nonregulatory measures. The effectiveness of elements in State
programs shall be evaluated by the Administrator based on the assessment prepared by
the National Academy of Sciences under
subparagraph (B) and the guidelines published by the Administrator under subparagraph (F).
(iii) APPROVAL.—The Administrator shall
approve a State program submitted under
this paragraph if the health risk reduction
benefits expected to be achieved by the program are equal to or greater than the health

Page 974

risk reduction benefits that would be
achieved if each public water system in the
State complied with the maximum contaminant level promulgated under subparagraph
(E). The Administrator shall approve or disapprove a program submitted under this
paragraph within 180 days of receipt. A program that is not disapproved during such period shall be deemed approved. A program
that is disapproved may be modified to address the objections of the Administrator
and be resubmitted for approval.
(iv) REVIEW.—The Administrator shall periodically, but not less often than every 5
years, review each multimedia mitigation
program approved under this subparagraph
to determine whether it continues to meet
the requirements of clause (iii) and shall,
after written notice to the State and an opportunity for the State to correct any deficiency in the program, withdraw approval of
programs that no longer comply with such
requirements.
(v) EXTENSION.—If, within 90 days after the
promulgation of an alternative maximum
contaminant level under subparagraph (F),
the Governor of a State submits a letter to
the Administrator committing to develop a
multimedia mitigation program under this
subparagraph, the effective date of the national primary drinking water regulation for
radon in the State that would be applicable
under paragraph (10) shall be extended for a
period of 18 months.
(vi) LOCAL PROGRAMS.—In the event that a
State chooses not to submit a multimedia
mitigation program for approval under this
subparagraph or has submitted a program
that has been disapproved, any public water
system in the State may submit a program
for approval by the Administrator according
to the same criteria, conditions, and approval process that would apply to a State
program. The Administrator shall approve a
multimedia mitigation program if the
health risk reduction benefits expected to be
achieved by the program are equal to or
greater than the health risk reduction benefits that would result from compliance by
the public water system with the maximum
contaminant level for radon promulgated
under subparagraph (E).
(14) RECYCLING OF FILTER BACKWASH.—The Administrator shall promulgate a regulation to
govern the recycling of filter backwash water
within the treatment process of a public water
system. The Administrator shall promulgate
such regulation not later than 4 years after August 6, 1996, unless such recycling has been addressed by the Administrator’s Enhanced Surface Water Treatment Rule prior to such date.
(15) VARIANCE TECHNOLOGIES.—
(A) IN GENERAL.—At the same time as the
Administrator promulgates a national primary drinking water regulation for a contaminant pursuant to this section, the Administrator shall issue guidance or regulations describing the best treatment technologies,
treatment techniques, or other means (referred to in this paragraph as ‘‘variance technology’’) for the contaminant that the Admin-

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

istrator finds, after examination for efficacy
under field conditions and not solely under
laboratory conditions, are available and affordable, as determined by the Administrator
in consultation with the States, for public
water systems of varying size, considering the
quality of the source water to be treated. The
Administrator shall identify such variance
technologies for public water systems serving—
(i) a population of 10,000 or fewer but more
than 3,300;
(ii) a population of 3,300 or fewer but more
than 500; and
(iii) a population of 500 or fewer but more
than 25,
if, considering the quality of the source water
to be treated, no treatment technology is listed for public water systems of that size under
paragraph (4)(E). Variance technologies identified by the Administrator pursuant to this
paragraph may not achieve compliance with
the maximum contaminant level or treatment
technique requirement of such regulation, but
shall achieve the maximum reduction or inactivation efficiency that is affordable considering the size of the system and the quality of
the source water. The guidance or regulations
shall not require the use of a technology from
a specific manufacturer or brand.
(B) LIMITATION.—The Administrator shall
not identify any variance technology under
this paragraph, unless the Administrator has
determined, considering the quality of the
source water to be treated and the expected
useful life of the technology, that the variance
technology is protective of public health.
(C) ADDITIONAL INFORMATION.—The Administrator shall include in the guidance or regulations identifying variance technologies under
this paragraph any assumptions supporting
the public health determination referred to in
subparagraph (B), where such assumptions
concern the public water system to which the
technology may be applied, or its source waters. The Administrator shall provide any assumptions used in determining affordability,
taking into consideration the number of persons served by such systems. The Administrator shall provide as much reliable information as practicable on performance, effectiveness, limitations, costs, and other relevant
factors including the applicability of variance
technology to waters from surface and underground sources.
(D) REGULATIONS AND GUIDANCE.—Not later
than 2 years after August 6, 1996, and after
consultation with the States, the Administrator shall issue guidance or regulations
under subparagraph (A) for each national primary drinking water regulation promulgated
prior to August 6, 1996, for which a variance
may be granted under section 300g–4(e) of this
title. The Administrator may, at any time
after a national primary drinking water regulation has been promulgated, issue guidance or
regulations describing additional variance
technologies. The Administrator shall, not
less often than every 7 years, or upon receipt
of a petition supported by substantial information, review variance technologies identi-

§ 300g–1

fied under this paragraph. The Administrator
shall issue revised guidance or regulations if
new or innovative variance technologies become available that meet the requirements of
this paragraph and achieve an equal or greater
reduction or inactivation efficiency than the
variance technologies previously identified
under this subparagraph. No public water system shall be required to replace a variance
technology during the useful life of the technology for the sole reason that a more efficient variance technology has been listed
under this subparagraph.
(c) Secondary regulations; publication of proposed regulations; promulgation; amendments
The Administrator shall publish proposed national secondary drinking water regulations
within 270 days after December 16, 1974. Within
90 days after publication of any such regulation,
he shall promulgate such regulation with such
modifications as he deems appropriate. Regulations under this subsection may be amended
from time to time.
(d) Regulations; public hearings; administrative
consultations
Regulations under this section shall be prescribed in accordance with section 553 of title 5
(relating to rulemaking), except that the Administrator shall provide opportunity for public
hearing prior to promulgation of such regulations. In proposing and promulgating regulations under this section, the Administrator shall
consult with the Secretary and the National
Drinking Water Advisory Council.
(e) Science Advisory Board comments
The Administrator shall request comments
from the Science Advisory Board (established
under the Environmental Research, Development, and Demonstration Act of 1978) prior to
proposal of a maximum contaminant level goal
and national primary drinking water regulation.
The Board shall respond, as it deems appropriate, within the time period applicable for promulgation of the national primary drinking
water standard concerned. This subsection shall,
under no circumstances, be used to delay final
promulgation of any national primary drinking
water standard.
(July 1, 1944, ch. 373, title XIV, § 1412, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1662;
amended Pub. L. 95–190, §§ 3(c), 12(a), Nov. 16,
1977, 91 Stat. 1394, 1398; Pub. L. 99–339, title I,
§ 101(a)–(c)(1), (d), (e), June 19, 1986, 100 Stat.
642–646; Pub. L. 104–182, title I, §§ 102(a), (c)(2),
103, 104(a), (c), 105–111(a), title V, § 501(a)(1), (2),
Aug. 6, 1996, 110 Stat. 1617, 1621–1623, 1625–1631,
1691.)
REFERENCES IN TEXT
The Federal Insecticide, Fungicide, and Rodenticide
Act, referred to in subsec. (b)(1)(B)(i)(II), is act June 25,
1947, ch. 125, as amended generally by Pub. L. 92–516,
Oct. 21, 1972, 86 Stat. 973, which is classified generally
to subchapter II (§ 136 et seq.) of chapter 6 of Title 7,
Agriculture. For complete classification of this Act to
the Code, see Short Title note set out under section 136
of Title 7 and Tables.
The Safe Drinking Water Act Amendments of 1996, referred to in subsec. (b)(13)(A), is Pub. L. 104–182, Aug. 6,

§ 300g–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1996, 110 Stat. 1613. For complete classification of this
Act to the Code, see Short Title of 1996 Amendment
note set out under section 201 of this title and Tables.
The Environmental Research, Development, and
Demonstration Act of 1978, referred to in subsec. (e),
probably means the Environmental Research, Development, and Demonstration Authorization Act of 1978
which is Pub. L. 95–155, Nov. 8, 1977, 91 Stat. 1257, as
amended. Provisions of the Act establishing the
Science Advisory Board are classified to section 4365 of
this title. For complete classification of this Act to the
Code, see Tables.
AMENDMENTS
1996—Subsec. (a)(3). Pub. L. 104–182, § 102(c)(2), struck
out ‘‘paragraph (1), (2), or (3) of’’ before ‘‘subsection
(b)’’ in two places.
Subsec. (b). Pub. L. 104–182, § 102(a), inserted heading.
Subsec. (b)(1), (2). Pub. L. 104–182, § 102(a), added pars.
(1) and (2) and struck out former pars. (1) and (2) which
related to publication of maximum contaminant level
goals and promulgation of national primary drinking
water regulations for certain listed contaminants or
substituted contaminants.
Subsec. (b)(3). Pub. L. 104–182, § 103, added par. (3).
Pub. L. 104–182, § 102(a), struck out par. (3) which related to publication of maximum contaminant level
goals and promulgation of national primary drinking
water regulations for contaminants, other than those
referred to in pars. (1) or (2), which may have an adverse effect on human health and are known to occur
in public water systems.
Subsec. (b)(4). Pub. L. 104–182, § 104(a)(1), designated
first sentence as subpar. (A), inserted par. and subpar.
(A) headings, designated second sentence as subpar. (B),
inserted subpar. (B) heading, substituted ‘‘Except as
provided in paragraphs (5) and (6), each national’’ for
‘‘Each national’’ and ‘‘specify a maximum contaminant
level’’ for ‘‘specify a maximum level’’, and added subpar. (C).
Subsec. (b)(4)(D). Pub. L. 104–182, § 104(a)(2), (3), redesignated par. (5) as subpar. (D) of par. (4), inserted subpar. heading, and substituted ‘‘this paragraph’’ for
‘‘paragraph (4)’’.
Subsec. (b)(4)(E). Pub. L. 104–182, §§ 104(a)(4), (5), 105,
redesignated par. (6) as subpar. (E)(i) of par. (4), inserted subpar. and cl. headings, substituted ‘‘this subsection’’ for ‘‘this paragraph’’, and added cls. (ii) to (v).
Subsec. (b)(5), (6). Pub. L. 104–182, § 104(a)(6), added
pars. (5) and (6). Former pars. (5) and (6) redesignated
subpars. (D) and (E)(i), respectively, of par. (4).
Subsec. (b)(7)(C)(v). Pub. L. 104–182, § 106, added cl. (v).
Subsec. (b)(8). Pub. L. 104–182, § 501(a)(2), substituted
‘‘section 300j–1(e)’’ for ‘‘section 300j–1(g)’’.
Pub. L. 104–182, § 107, inserted heading, realigned margins, and substituted ‘‘At any time after the end of the
3-year period that begins on August 6, 1996, but not
later than the date on which the Administrator promulgates a Stage II rulemaking for disinfectants and
disinfection byproducts (as described in paragraph
(2)(C)), the Administrator shall also promulgate national primary drinking water regulations requiring
disinfection as a treatment technique for all public
water systems, including surface water systems and, as
necessary, ground water systems. After consultation
with the States, the Administrator shall (as part of the
regulations) promulgate criteria that the Administrator, or a State that has primary enforcement responsibility under section 300g–2 of this title, shall
apply to determine whether disinfection shall be required as a treatment technique for any public water
system served by ground water.’’ for ‘‘Not later than 36
months after June 19, 1986, the Administrator shall propose and promulgate national primary drinking water
regulations requiring disinfection as a treatment technique for all public water systems.’’
Subsec. (b)(9). Pub. L. 104–182, § 104(c), amended par.
(9) generally. Prior to amendment, par. (9) read as follows: ‘‘National primary drinking water regulations
shall be amended whenever changes in technology,

Page 976

treatment techniques, and other means permit greater
protection of the health of persons, but in any event
such regulations shall be reviewed at least once every
3 years. Such review shall include an analysis of innovations or changes in technology, treatment techniques
or other activities that have occurred over the previous
3-year period and that may provide for greater protection of the health of persons. The findings of such review shall be published in the Federal Register. If, after
opportunity for public comment, the Administrator
concludes that the technology, treatment techniques,
or other means resulting from such innovations or
changes are not feasible within the meaning of paragraph (5), an explanation of such conclusion shall be
published in the Federal Register.’’
Subsec. (b)(10). Pub. L. 104–182, § 108, amended par. (10)
generally. Prior to amendment, par. (10) read as follows: ‘‘National primary drinking water regulations
promulgated under this subsection (and amendments
thereto) shall take effect eighteen months after the
date of their promulgation. Regulations under subsection (a) of this section shall be superseded by regulations under this subsection to the extent provided by
the regulations under this subsection.’’
Subsec. (b)(11). Pub. L. 104–182, § 501(a)(1), realigned
margins.
Subsec. (b)(12). Pub. L. 104–182, § 109(a), added par. (12).
Subsec. (b)(13). Pub. L. 104–182, § 109(b), added par. (13).
Subsec. (b)(14). Pub. L. 104–182, § 110, added par. (14).
Subsec. (b)(15). Pub. L. 104–182, § 111(a), added par. (15).
1986—Subsec. (a). Pub. L. 99–339, § 101(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) read
as follows:
‘‘(1) The Administrator shall publish proposed national interim primary drinking water regulations
within 90 days after December 16, 1974. Within 180 days
after December 16, 1974, he shall promulgate such regulations with such modifications as he deems appropriate. Regulations under this paragraph may be
amended from time to time.
‘‘(2) National interim primary drinking water regulations promulgated under paragraph (1) shall protect
health to the extent feasible, using technology, treatment techniques, and other means, which the Administrator determines are generally available (taking costs
into consideration) on December 16, 1974.
‘‘(3) The interim primary regulations first promulgated under paragraph (1) shall take effect eighteen
months after the date of their promulgation.’’
Subsec. (b)(1). Pub. L. 99–339, § 101(b), substituted provisions establishing standard setting schedules and
deadlines for provisions relating to establishment of
maximum contaminant levels and a list of contaminants with adverse effect but of undetermined levels.
Subsec. (b)(2). Pub. L. 99–339, § 101(b), substituted provisions authorizing the Administrator to substitute
contaminants for those referred to in par. (1) and to
supply a list of the contaminants proposed for substitution, with the decision of the Administrator to regulate such contaminant not subject to judicial review,
for provisions which authorized the Administrator to
publish in the Federal Register proposed revised national interim primary drinking water regulations and
180 days after the date of such proposed regulations to
promulgate such revised regulations with modification
as deemed appropriate.
Subsec. (b)(3). Pub. L. 99–339, § 101(b), substituted provisions directing the Administrator to publish maximum contaminant level goals and promulgate national
primary drinking water regulations for contaminants,
other than specified in par. (1) or (2), which may have
an adverse effect on health and are known or anticipated to occur in public water systems, to establish an
advisory working group to aid in establishing a list of
such contaminants, and to publish, within a specified
time, both proposed and final goals and regulations for
provisions which required that revised national primary drinking water regulations specify a maximum
contaminant level or require the use of treatment techniques for each contaminant, which level or technique

Page 977

TITLE 42—THE PUBLIC HEALTH AND WELFARE

was to be as close to the recommended level or technique as feasible, and defined the term ‘‘feasible’’.
Subsec. (b)(4) to (11). Pub. L. 99–339, § 101(b), (c)(1), (d),
added pars. (4) to (8), redesignated former pars. (4) to (6)
as pars. (9) to (11), respectively, in par. (9) substituted
‘‘National’’ for ‘‘Revised National’’ and inserted provision that review include analysis, and publication in
Federal Register, of innovations in technology, treatment techniques or other activities occurring during
previous three years and their feasibility, and in par.
(10) substituted ‘‘National’’ for ‘‘Revised National’’.
Subsec. (e). Pub. L. 99–339, § 101(e), amended subsec.
(e) generally, substituting provisions which relate to
the request by the Administrator of comments by the
Science Advisory Board prior to proposal of a maximum contaminant level goal and national primary
drinking water regulation for provisions which related
to study by the National Academy of Sciences to determine the maximum contaminant levels, report to Congress, and funding therefor.
1977—Subsec. (e)(2). Pub. L. 95–190 inserted provisions
relating to revisions of the required report and cl. (G).
NATIONAL PRIMARY DRINKING WATER REGULATION FOR
ARSENIC
Pub. L. 106–377, § 1(a)(1) [title III], Oct. 27, 2000, 114
Stat. 1441, 1441A–41, provided in part: ‘‘That notwithstanding section 1412(b)(12)(A)(v) of the Safe Drinking
Water Act, as amended [subsec. (b)(12)(A)(v) of this section], the Administrator shall promulgate a national
primary drinking water regulation for arsenic not later
than June 22, 2001.’’
APPLICABILITY OF PRIOR REQUIREMENTS
Section 102(b) of Pub. L. 104–182 provided that: ‘‘The
requirements of subparagraphs (C) and (D) of section
1412(b)(3) of the Safe Drinking Water Act [subsec.
(b)(3)(C), (D) of this section] as in effect before the date
of enactment of this Act [Aug. 6, 1996], and any obligation to promulgate regulations pursuant to such subparagraphs not promulgated as of the date of enactment of this Act, are superseded by the amendments
made by subsection (a) [amending this section].’’
DISINFECTANTS AND DISINFECTION BYPRODUCTS
Section 104(b) of Pub. L. 104–182 provided that: ‘‘The
Administrator of the Environmental Protection Agency may use the authority of section 1412(b)(5) of the
Safe Drinking Water Act [subsec. (b)(5) of this section]
(as amended by this Act) to promulgate the Stage I and
Stage II Disinfectants and Disinfection Byproducts
Rules as proposed in volume 59, Federal Register, page
38668 (July 29, 1994). The considerations used in the development of the July 29, 1994, proposed national primary drinking water regulation on disinfectants and
disinfection byproducts shall be treated as consistent
with such section 1412(b)(5) for purposes of such Stage
I and Stage II rules.’’

§ 300g–2. State primary enforcement responsibility
(a) In general
For purposes of this subchapter, a State has
primary enforcement responsibility for public
water systems during any period for which the
Administrator determines (pursuant to regulations prescribed under subsection (b) of this section) that such State—
(1) has adopted drinking water regulations
that are no less stringent than the national
primary drinking water regulations promulgated by the Administrator under subsections
(a) and (b) of section 300g–1 of this title not
later than 2 years after the date on which the
regulations are promulgated by the Administrator, except that the Administrator may

§ 300g–2

provide for an extension of not more than 2
years if, after submission and review of appropriate, adequate documentation from the
State, the Administrator determines that the
extension is necessary and justified;
(2) has adopted and is implementing adequate procedures for the enforcement of such
State regulations, including conducting such
monitoring and making such inspections as
the Administrator may require by regulation;
(3) will keep such records and make such reports with respect to its activities under paragraphs (1) and (2) as the Administrator may require by regulation;
(4) if it permits variances or exemptions, or
both, from the requirements of its drinking
water regulations which meet the requirements of paragraph (1), permits such variances
and exemptions under conditions and in a
manner which is not less stringent than the
conditions under, and the manner in which
variances and exemptions may be granted
under sections 300g–4 and 300g–5 of this title;
(5) has adopted and can implement an adequate plan for the provision of safe drinking
water under emergency circumstances including earthquakes, floods, hurricanes, and other
natural disasters, as appropriate; and
(6) has adopted authority for administrative
penalties (unless the constitution of the State
prohibits the adoption of the authority) in a
maximum amount—
(A) in the case of a system serving a population of more than 10,000, that is not less
than $1,000 per day per violation; and
(B) in the case of any other system, that is
adequate to ensure compliance (as determined by the State);
except that a State may establish a maximum
limitation on the total amount of administrative penalties that may be imposed on a public
water system per violation.
(b) Regulations
(1) The Administrator shall, by regulation
(proposed within 180 days of December 16, 1974),
prescribe the manner in which a State may
apply to the Administrator for a determination
that the requirements of paragraphs (1), (2), (3),
and (4) of subsection (a) of this section are satisfied with respect to the State, the manner in
which the determination is made, the period for
which the determination will be effective, and
the manner in which the Administrator may determine that such requirements are no longer
met. Such regulations shall require that before
a determination of the Administrator that such
requirements are met or are no longer met with
respect to a State may become effective, the Administrator shall notify such State of the determination and the reasons therefor and shall provide an opportunity for public hearing on the determination. Such regulations shall be promulgated (with such modifications as the Administrator deems appropriate) within 90 days of the
publication of the proposed regulations in the
Federal Register. The Administrator shall
promptly notify in writing the chief executive
officer of each State of the promulgation of regulations under this paragraph. Such notice shall
contain a copy of the regulations and shall

§ 300g–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

specify a State’s authority under this subchapter when it is determined to have primary
enforcement responsibility for public water systems.
(2) When an application is submitted in accordance with the Administrator’s regulations
under paragraph (1), the Administrator shall
within 90 days of the date on which such application is submitted (A) make the determination
applied for, or (B) deny the application and notify the applicant in writing of the reasons for
his denial.
(c) Interim primary enforcement authority
A State that has primary enforcement authority under this section with respect to each existing national primary drinking water regulation
shall be considered to have primary enforcement
authority with respect to each new or revised
national primary drinking water regulation during the period beginning on the effective date of
a regulation adopted and submitted by the State
with respect to the new or revised national primary drinking water regulation in accordance
with subsection (b)(1) of this section and ending
at such time as the Administrator makes a determination under subsection (b)(2)(B) of this
section with respect to the regulation.
(July 1, 1944, ch. 373, title XIV, § 1413, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1665;
amended Pub. L. 99–339, title I, § 101(c)(2), June
19, 1986, 100 Stat. 646; Pub. L. 104–182, title I,
§§ 112, 113(b), Aug. 6, 1996, 110 Stat. 1633, 1635.)
AMENDMENTS
1996—Subsec. (a)(1). Pub. L. 104–182, § 112(a)(1), amended par. (1) generally. Prior to amendment, par. (1) read
as follows: ‘‘has adopted drinking water regulations
which are no less stringent than the national primary
drinking water regulations in effect under sections
300g–1(a) and 300g–1(b) of this title;’’.
Subsec. (a)(5). Pub. L. 104–182, § 112(b), inserted ‘‘including earthquakes, floods, hurricanes, and other natural disasters, as appropriate’’ after ‘‘emergency circumstances’’.
Subsec. (a)(6). Pub. L. 104–182, § 113(b), added par. (6).
Subsec. (c). Pub. L. 104–182, § 112(a)(2), added subsec.
(c).
1986—Subsec. (a)(1). Pub. L. 99–339 substituted ‘‘are no
less stringent than the national primary drinking
water regulations in effect under sections 300g–1(a) and
300g–1(b) of this title’’ for subpars. (A) and (B) which related to stringency of State drinking water regulations
between period of promulgation and effective date of
national interim drinking water regulations and during
the period after such effective date.

§ 300g–3. Enforcement of drinking water regulations
(a) Notice to State and public water system; issuance of administrative order; civil action
(1)(A) Whenever the Administrator finds during a period during which a State has primary
enforcement responsibility for public water systems (within the meaning of section 300g–2(a) of
this title) that any public water system—
(i) for which a variance under section 300g–4
or an exemption under section 300g–5 of this
title is not in effect, does not comply with any
applicable requirement, or
(ii) for which a variance under section 300g–4
or an exemption under section 300g–5 of this
title is in effect, does not comply with any

Page 978

schedule or other requirement imposed pursuant thereto,
he shall so notify the State and such public
water system and provide such advice and technical assistance to such State and public water
system as may be appropriate to bring the system into compliance with the requirement by
the earliest feasible time.
(B) If, beyond the thirtieth day after the Administrator’s notification under subparagraph
(A), the State has not commenced appropriate
enforcement action, the Administrator shall
issue an order under subsection (g) of this section requiring the public water system to comply with such applicable requirement or the Administrator shall commence a civil action under
subsection (b) of this section.
(2) ENFORCEMENT IN NONPRIMACY STATES.—
(A) IN GENERAL.—If, on the basis of information available to the Administrator, the Administrator finds, with respect to a period in
which a State does not have primary enforcement responsibility for public water systems,
that a public water system in the State—
(i) for which a variance under section
300g–4 of this title or an exemption under
section 300g–5 of this title is not in effect,
does not comply with any applicable requirement; or
(ii) for which a variance under section
300g–4 of this title or an exemption under
section 300g–5 of this title is in effect, does
not comply with any schedule or other requirement imposed pursuant to the variance
or exemption;
the Administrator shall issue an order under
subsection (g) of this section requiring the
public water system to comply with the requirement, or commence a civil action under
subsection (b) of this section.
(B) NOTICE.—If the Administrator takes any
action pursuant to this paragraph, the Administrator shall notify an appropriate local
elected official, if any, with jurisdiction over
the public water system of the action prior to
the time that the action is taken.
(b) Judicial determinations in appropriate Federal district courts; civil penalties, separate
violations
The Administrator may bring a civil action in
the appropriate United States district court to
require compliance with any applicable requirement, with an order issued under subsection (g)
of this section, or with any schedule or other requirement imposed pursuant to a variance or exemption granted under section 300g–4 or 300g–5
of this title if—
(1) authorized under paragraph (1) or (2) of
subsection (a) of this section, or
(2) if requested by (A) the chief executive officer of the State in which is located the public water system which is not in compliance
with such regulation or requirement, or (B)
the agency of such State which has jurisdiction over compliance by public water systems
in the State with national primary drinking
water regulations or State drinking water regulations.
The court may enter, in an action brought under
this subsection, such judgement as protection of

Page 979

TITLE 42—THE PUBLIC HEALTH AND WELFARE

public health may require, taking into consideration the time necessary to comply and the
availability of alternative water supplies; and, if
the court determines that there has been a violation of the regulation or schedule or other requirement with respect to which the action was
brought, the court may, taking into account the
seriousness of the violation, the population at
risk, and other appropriate factors, impose on
the violator a civil penalty of not to exceed
$25,000 for each day in which such violation occurs.
(c) Notice to persons served
(1) In general
Each owner or operator of a public water
system shall give notice of each of the following to the persons served by the system:
(A) Notice of any failure on the part of the
public water system to—
(i) comply with an applicable maximum
contaminant level or treatment technique
requirement of, or a testing procedure prescribed by, a national primary drinking
water regulation; or
(ii) perform monitoring required by section 300j–4(a) of this title.
(B) If the public water system is subject to
a
variance
granted
under
subsection
(a)(1)(A), (a)(2), or (e) of section 300g–4 of this
title for an inability to meet a maximum
contaminant level requirement or is subject
to an exemption granted under section
300g–5 of this title, notice of—
(i) the existence of the variance or exemption; and
(ii) any failure to comply with the requirements of any schedule prescribed pursuant to the variance or exemption.
(C) Notice of the concentration level of
any unregulated contaminant for which the
Administrator has required public notice
pursuant to paragraph (2)(E).
(2) Form, manner, and frequency of notice
(A) In general
The Administrator shall, by regulation,
and after consultation with the States, prescribe the manner, frequency, form, and content for giving notice under this subsection.
The regulations shall—
(i) provide for different frequencies of notice based on the differences between violations that are intermittent or infrequent
and violations that are continuous or frequent; and
(ii) take into account the seriousness of
any potential adverse health effects that
may be involved.
(B) State requirements
(i) In general
A State may, by rule, establish alternative notification requirements—
(I) with respect to the form and content of notice given under and in a manner in accordance with subparagraph (C);
and
(II) with respect to the form and content of notice given under subparagraph
(D).

§ 300g–3

(ii) Contents
The alternative requirements shall provide the same type and amount of information as required pursuant to this subsection and regulations issued under subparagraph (A).
(iii) Relationship to section 300g–2
Nothing in this subparagraph shall be
construed or applied to modify the requirements of section 300g–2 of this title.
(C) Violations with potential to have serious
adverse effects on human health
Regulations issued under subparagraph (A)
shall specify notification procedures for each
violation by a public water system that has
the potential to have serious adverse effects
on human health as a result of short-term
exposure. Each notice of violation provided
under this subparagraph shall—
(i) be distributed as soon as practicable
after the occurrence of the violation, but
not later than 24 hours after the occurrence of the violation;
(ii) provide a clear and readily understandable explanation of—
(I) the violation;
(II) the potential adverse effects on
human health;
(III) the steps that the public water
system is taking to correct the violation; and
(IV) the necessity of seeking alternative water supplies until the violation
is corrected;
(iii) be provided to the Administrator or
the head of the State agency that has primary enforcement responsibility under
section 300g–2 of this title as soon as practicable, but not later than 24 hours after
the occurrence of the violation; and
(iv) as required by the State agency in
general regulations of the State agency, or
on a case-by-case basis after the consultation referred to in clause (iii), considering
the health risks involved—
(I) be provided to appropriate broadcast media;
(II) be prominently published in a
newspaper of general circulation serving
the area not later than 1 day after distribution of a notice pursuant to clause
(i) or the date of publication of the next
issue of the newspaper; or
(III) be provided by posting or door-todoor notification in lieu of notification
by means of broadcast media or newspaper.
(D) Written notice
(i) In general
Regulations issued under subparagraph
(A) shall specify notification procedures
for violations other than the violations
covered by subparagraph (C). The procedures shall specify that a public water system shall provide written notice to each
person served by the system by notice (I)
in the first bill (if any) prepared after the
date of occurrence of the violation, (II) in

§ 300g–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

an annual report issued not later than 1
year after the date of occurrence of the
violation, or (III) by mail or direct delivery as soon as practicable, but not later
than 1 year after the date of occurrence of
the violation.
(ii) Form and manner of notice
The Administrator shall prescribe the
form and manner of the notice to provide
a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps that the
system is taking to seek alternative water
supplies, if any, until the violation is corrected.
(E) Unregulated contaminants
The Administrator may require the owner
or operator of a public water system to give
notice to the persons served by the system of
the concentration levels of an unregulated
contaminant required to be monitored under
section 300j–4(a) of this title.
(3) Reports
(A) Annual report by State
(i) In general
Not later than January 1, 1998, and annually thereafter, each State that has primary enforcement responsibility under
section 300g–2 of this title shall prepare,
make readily available to the public, and
submit to the Administrator an annual report on violations of national primary
drinking water regulations by public water
systems in the State, including violations
with respect to (I) maximum contaminant
levels, (II) treatment requirements, (III)
variances and exemptions, and (IV) monitoring requirements determined to be significant by the Administrator after consultation with the States.
(ii) Distribution
The State shall publish and distribute
summaries of the report and indicate
where the full report is available for review.
(B) Annual report by Administrator
Not later than July 1, 1998, and annually
thereafter, the Administrator shall prepare
and make available to the public an annual
report summarizing and evaluating reports
submitted by States pursuant to subparagraph (A) and notices submitted by public
water systems serving Indian Tribes provided to the Administrator pursuant to subparagraph (C) or (D) of paragraph (2) and
making recommendations concerning the resources needed to improve compliance with
this subchapter. The report shall include information about public water system compliance on Indian reservations and about enforcement activities undertaken and financial assistance provided by the Administrator on Indian reservations, and shall
make specific recommendations concerning
the resources needed to improve compliance
with this subchapter on Indian reservations.

Page 980

(4) Consumer confidence reports by community water systems
(A) Annual reports to consumers
The Administrator, in consultation with
public water systems, environmental groups,
public interest groups, risk communication
experts, and the States, and other interested
parties, shall issue regulations within 24
months after August 6, 1996, to require each
community water system to mail to each
customer of the system at least once annually a report on the level of contaminants in
the drinking water purveyed by that system
(referred to in this paragraph as a ‘‘consumer confidence report’’). Such regulations
shall provide a brief and plainly worded definition of the terms ‘‘maximum contaminant
level goal’’, ‘‘maximum contaminant level’’,
‘‘variances’’, and ‘‘exemptions’’ and brief
statements in plain language regarding the
health concerns that resulted in regulation
of each regulated contaminant. The regulations shall also include a brief and plainly
worded explanation regarding contaminants
that may reasonably be expected to be
present in drinking water, including bottled
water. The regulations shall also provide for
an Environmental Protection Agency tollfree hotline that consumers can call for
more information and explanation.
(B) Contents of report
The consumer confidence reports under
this paragraph shall include, but not be limited to, each of the following:
(i) Information on the source of the
water purveyed.
(ii) A brief and plainly worded definition
of the terms ‘‘maximum contaminant level
goal’’, ‘‘maximum contaminant level’’,
‘‘variances’’, and ‘‘exemptions’’ as provided in the regulations of the Administrator.
(iii) If any regulated contaminant is detected in the water purveyed by the public
water system, a statement setting forth (I)
the maximum contaminant level goal, (II)
the maximum contaminant level, (III) the
level of such contaminant in such water
system, and (IV) for any regulated contaminant for which there has been a violation of the maximum contaminant level
during the year concerned, the brief statement in plain language regarding the
health concerns that resulted in regulation
of such contaminant, as provided by the
Administrator in regulations under subparagraph (A).
(iv) Information on compliance with national primary drinking water regulations,
as required by the Administrator, and notice if the system is operating under a
variance or exemption and the basis on
which the variance or exemption was
granted.
(v) Information on the levels of unregulated contaminants for which monitoring
is required under section 300j–4(a)(2) of this
title (including levels of cryptosporidium
and radon where States determine they
may be found).

Page 981

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(vi) A statement that the presence of
contaminants in drinking water does not
necessarily indicate that the drinking
water poses a health risk and that more
information about contaminants and potential health effects can be obtained by
calling the Environmental Protection
Agency hotline.
A public water system may include such additional information as it deems appropriate
for public education. The Administrator
may, for not more than 3 regulated contaminants other than those referred to in subclause (IV) of clause (iii), require a consumer
confidence report under this paragraph to
include the brief statement in plain language regarding the health concerns that resulted in regulation of the contaminant or
contaminants concerned, as provided by the
Administrator in regulations under subparagraph (A).
(C) Coverage
The Governor of a State may determine
not to apply the mailing requirement of subparagraph (A) to a community water system
serving fewer than 10,000 persons. Any such
system shall—
(i) inform, in the newspaper notice required by clause (iii) or by other means,
its customers that the system will not be
mailing the report as required by subparagraph (A);
(ii) make the consumer confidence report
available upon request to the public; and
(iii) publish the report referred to in subparagraph (A) annually in one or more
local newspapers serving the area in which
customers of the system are located.
(D) Alternative to publication
For any community water system which,
pursuant to subparagraph (C), is not required to meet the mailing requirement of
subparagraph (A) and which serves 500 persons or fewer, the community water system
may elect not to comply with clause (i) or
(iii) of subparagraph (C). If the community
water system so elects, the system shall, at
a minimum—
(i) prepare an annual consumer confidence report pursuant to subparagraph
(B); and
(ii) provide notice at least once per year
to each of its customers by mail, by doorto-door delivery, by posting or by other
means authorized by the regulations of the
Administrator that the consumer confidence report is available upon request.
(E) Alternative form and content
A State exercising primary enforcement
responsibility may establish, by rule, after
notice and public comment, alternative requirements with respect to the form and
content of consumer confidence reports
under this paragraph.
(d) Notice of noncompliance with secondary
drinking water regulations
Whenever, on the basis of information available to him, the Administrator finds that within

§ 300g–3

a reasonable time after national secondary
drinking water regulations have been promulgated, one or more public water systems in a
State do not comply with such secondary regulations, and that such noncompliance appears to
result from a failure of such State to take reasonable action to assure that public water systems throughout such State meet such secondary regulations, he shall so notify the State.
(e) State authority to adopt or enforce laws or
regulations respecting drinking water regulations or public water systems unaffected
Nothing in this subchapter shall diminish any
authority of a State or political subdivision to
adopt or enforce any law or regulation respecting drinking water regulations or public water
systems, but no such law or regulation shall relieve any person of any requirement otherwise
applicable under this subchapter.
(f) Notice and public hearing; availability of recommendations transmitted to State and public water system
If the Administrator makes a finding of noncompliance (described in subparagraph (A) or (B)
of subsection (a)(1) of this section) with respect
to a public water system in a State which has
primary enforcement responsibility, the Administrator may, for the purpose of assisting that
State in carrying out such responsibility and
upon the petition of such State or public water
system or persons served by such system, hold,
after appropriate notice, public hearings for the
purpose of gathering information from technical
or other experts, Federal, State, or other public
officials, representatives of such public water
system, persons served by such system, and
other interested persons on—
(1) the ways in which such system can within the earliest feasible time be brought into
compliance with the regulation or requirement with respect to which such finding was
made, and
(2) the means for the maximum feasible protection of the public health during any period
in which such system is not in compliance
with a national primary drinking water regulation or requirement applicable to a variance
or exemption.
On the basis of such hearings the Administrator
shall issue recommendations which shall be sent
to such State and public water system and shall
be made available to the public and communications media.
(g) Administrative order requiring compliance;
notice and hearing; civil penalty; civil actions
(1) In any case in which the Administrator is
authorized to bring a civil action under this section or under section 300j–4 of this title with respect to any applicable requirement, the Administrator also may issue an order to require compliance with such applicable requirement.
(2) An order issued under this subsection shall
not take effect, in the case of a State having primary enforcement responsibility for public
water systems in that State, until after the Administrator has provided the State with an opportunity to confer with the Administrator regarding the order. A copy of any order issued

§ 300g–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

under this subsection shall be sent to the appropriate State agency of the State involved if the
State has primary enforcement responsibility
for public water systems in that State. Any
order issued under this subsection shall state
with reasonable specificity the nature of the
violation. In any case in which an order under
this subsection is issued to a corporation, a copy
of such order shall be issued to appropriate corporate officers.
(3)(A) Any person who violates, or fails or refuses to comply with, an order under this subsection shall be liable to the United States for a
civil penalty of not more than $25,000 per day of
violation.
(B) In a case in which a civil penalty sought by
the Administrator under this paragraph does not
exceed $5,000, the penalty shall be assessed by
the Administrator after notice and opportunity
for a public hearing (unless the person against
whom the penalty is assessed requests a hearing
on the record in accordance with section 554 of
title 5). In a case in which a civil penalty sought
by the Administrator under this paragraph exceeds $5,000, but does not exceed $25,000, the penalty shall be assessed by the Administrator after
notice and opportunity for a hearing on the
record in accordance with section 554 of title 5.
(C) Whenever any civil penalty sought by the
Administrator under this subsection for a violation of an applicable requirement exceeds
$25,000, the penalty shall be assessed by a civil
action brought by the Administrator in the appropriate United States district court (as determined under the provisions of title 28).
(D) If any person fails to pay an assessment of
a civil penalty after it has become a final and
unappealable order, or after the appropriate
court of appeals has entered final judgment in
favor of the Administrator, the Attorney General shall recover the amount for which such
person is liable in any appropriate district court
of the United States. In any such action, the validity and appropriateness of the final order imposing the civil penalty shall not be subject to
review.
(h) Consolidation incentive
(1) In general
An owner or operator of a public water system may submit to the State in which the system is located (if the State has primary enforcement responsibility under section 300g–2
of this title) or to the Administrator (if the
State does not have primary enforcement responsibility) a plan (including specific measures and schedules) for—
(A) the physical consolidation of the system with 1 or more other systems;
(B) the consolidation of significant management and administrative functions of the
system with 1 or more other systems; or
(C) the transfer of ownership of the system
that may reasonably be expected to improve
drinking water quality.
(2) Consequences of approval
If the State or the Administrator approves a
plan pursuant to paragraph (1), no enforcement action shall be taken pursuant to this
part with respect to a specific violation identi-

Page 982

fied in the approved plan prior to the date that
is the earlier of the date on which consolidation is completed according to the plan or the
date that is 2 years after the plan is approved.
(i) ‘‘Applicable requirement’’ defined
In this section, the term ‘‘applicable requirement’’ means—
(1) a requirement of section 300g–1, 300g–3,
300g–4, 300g–5, 300g–6 1 300i–2, 300j, or 300j–4 of
this title;
(2) a regulation promulgated pursuant to a
section referred to in paragraph (1);
(3) a schedule or requirement imposed pursuant to a section referred to in paragraph (1);
and
(4) a requirement of, or permit issued under,
an applicable State program for which the Administrator has made a determination that
the requirements of section 300g–2 of this title
have been satisfied, or an applicable State program approved pursuant to this part.
(July 1, 1944, ch. 373, title XIV, § 1414, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1666;
amended Pub. L. 95–190, § 12(b), Nov. 16, 1977, 91
Stat. 1398; Pub. L. 99–339, title I, §§ 102, 103, June
19, 1986, 100 Stat. 647, 648; Pub. L. 104–182, title I,
§§ 113(a), 114(a), Aug. 6, 1996, 110 Stat. 1634, 1636;
Pub. L. 107–188, title IV, § 403(1), June 12, 2002, 116
Stat. 687.)
AMENDMENTS
2002—Subsec. (i)(1). Pub. L. 107–188 inserted ‘‘300i–2’’
after ‘‘300g–6’’.
1996—Subsec.
(a)(1)(A).
Pub.
L.
104–182,
§ 113(a)(1)(A)(i)(II), substituted ‘‘with the requirement’’
for ‘‘with such regulation or requirement’’ in concluding provisions.
Subsec. (a)(1)(A)(i). Pub. L. 104–182, § 113(a)(1)(A)(i)(I),
substituted ‘‘any applicable requirement’’ for ‘‘any national primary drinking water regulation in effect
under section 300g–1 of this title’’.
Subsec. (a)(1)(B). Pub. L. 104–182, § 113(a)(1)(A)(ii), substituted ‘‘such applicable requirement’’ for ‘‘such regulation or requirement’’.
Subsec. (a)(2). Pub. L. 104–182, § 113(a)(1)(B), added par.
(2) and struck out former par. (2) which read as follows:
‘‘Whenever, on the basis of information available to
him, the Administrator finds during a period during
which a State does not have primary enforcement responsibility for public water systems that a public
water system in such State—
‘‘(A) for which a variance under section 300g–4(a)(2)
or an exemption under section 300g–5(f) of this title is
not in effect, does not comply with any national primary drinking water regulation in effect under section 300g–1 of this title, or
‘‘(B) for which a variance under section 300g–4(a)(2)
or an exemption under section 300g–5(f) of this title is
in effect, does not comply with any schedule or other
requirement imposed pursuant thereto,
the Administrator shall issue an order under subsection
(g) of this section requiring the public water system to
comply with such regulation or requirement or the Administrator shall commence a civil action under subsection (b) of this section.’’
Subsec. (b). Pub. L. 104–182, § 113(a)(2), substituted
‘‘any applicable requirement’’ for ‘‘a national primary
drinking water regulation’’ in introductory provisions.
Subsec. (c). Pub. L. 104–182, § 114(a), amended subsec.
(c) generally. Prior to amendment, subsec. (c) related
to notice of owner or operator of public water system
to persons served, regulations for form, manner, and
1 So

in original. There probably should be a comma.

Page 983

TITLE 42—THE PUBLIC HEALTH AND WELFARE

frequency of notice, amendment of regulations to provide different types and frequencies of notice, and penalties.
Subsec. (g)(1). Pub. L. 104–182, § 113(a)(3)(A), substituted ‘‘applicable requirement’’ for ‘‘regulation,
schedule, or other requirement’’ in two places.
Subsec. (g)(2). Pub. L. 104–182, § 113(a)(3)(B), substituted ‘‘effect, in the case’’ for ‘‘effect until after notice and opportunity for public hearing and, in the
case’’ and ‘‘regarding the order’’ for ‘‘regarding the proposed order’’ and struck out ‘‘proposed to be’’ after ‘‘A
copy of any order’’.
Subsec. (g)(3)(B). Pub. L. 104–182, § 113(a)(3)(C)(i),
added subpar. (B) and struck out former subpar. (B)
which read as follows: ‘‘Whenever any civil penalty
sought by the Administrator under this paragraph does
not exceed a total of $5,000, the penalty shall be assessed by the Administrator after notice and opportunity for a hearing on the record in accordance with
section 554 of title 5.’’
Subsec. (g)(3)(C). Pub. L. 104–182, § 113(a)(3)(C)(ii), substituted ‘‘subsection for a violation of an applicable requirement exceeds $25,000’’ for ‘‘paragraph exceeds
$5,000’’.
Subsecs. (h), (i). Pub. L. 104–182, § 113(a)(4), added subsecs. (h) and (i).
1986—Pub. L. 99–339, § 102(d)(2), substituted ‘‘Enforcement’’ for ‘‘Failure of State to assure enforcement’’ in
section catchline.
Subsec. (a)(1)(A). Pub. L. 99–339, § 102(a), inserted ‘‘and
such public water system’’ after ‘‘notify the State’’ in
provisions following cl. (ii).
Subsec. (a)(1)(B). Pub. L. 99–339, § 102(b)(1), amended
subpar. (B) generally, substituting provisions which relate to issuance of an order to public water system to
comply with regulations, or commencement of civil action if the State has not commenced appropriate enforcement action for provisions which related to public
notice of noncompliance and commencement of civil
action by Administrator if State failed to take steps to
obtain compliance by public water system.
Subsec. (a)(2). Pub. L. 99–339, § 102(b)(2), substituted
‘‘the Administrator shall issue an order under subsection (g) of this section requiring the public water
system to comply with such regulation or requirement
or the Administrator shall commence a civil action
under subsection (b) of this section’’ for ‘‘he may commence a civil action under subsection (b) of this section’’.
Subsec. (b). Pub. L. 99–339, § 102(c), inserted ‘‘, with an
order issued under subsection (g) of this section,’’ before ‘‘or with any schedule’’ and substituted ‘‘there has
been a violation’’ for ‘‘there has been a willful violation’’ and ‘‘$25,000’’ for ‘‘$5,000’’.
Subsec. (c). Pub. L. 99–339, § 103, substituted provisions relating to amendment of regulations within fifteen months after June 19, 1986, to provide different
types and frequencies of notice based on the differences
between violations which are intermittent or continuous, manner and content of notices, notice required to
public served by owner or operator of public water system, and civil penalty of $25,000, for provisions relating
to form, manner, and frequency of notice based on
three month billing period for water bills, notice required to public served by owner or operator of public
water system, and civil penalty of $5,000.
Subsec. (g). Pub. L. 99–339, § 102(d), added subsec. (g).
1977—Subsec. (c). Pub. L. 95–190 inserted provisions
relating to frequency of required notice, and notice respecting contaminant levels, and substituted ‘‘issued
under this subsection’’ for ‘‘thereunder’’.

§ 300g–4

§ 300g–4. Variances
(a) Characteristics of raw water sources; specific
treatment technique; notice to Administrator, reasons for variance; compliance, enforcement; approval or revision of schedules
and revocation of variances; review of variances and schedules; publication in Federal
Register, notice and results of review; notice
to State; considerations respecting abuse of
discretion in granting variances or failing to
prescribe schedules; State corrective action;
authority of Administrator in a State without
primary enforcement responsibility; alternative treatment techniques
Notwithstanding any other provision of this
part, variances from national primary drinking
water regulations may be granted as follows:
(1)(A) A State which has primary enforcement responsibility for public water systems
may grant one or more variances from an applicable national primary drinking water regulation to one or more public water systems
within its jurisdiction which, because of characteristics of the raw water sources which are
reasonably available to the systems, cannot
meet the requirements respecting the maximum contaminant levels of such drinking
water regulation. A variance may be issued to
a system on condition that the system install
the best technology, treatment techniques, or
other means, which the Administrator finds
are available (taking costs into consideration),
and based upon an evaluation satisfactory to
the State that indicates that alternative
sources of water are not reasonably available
to the system. The Administrator shall propose and promulgate his finding of the best
available technology, treatment techniques or
other means available for each contaminant
for purposes of this subsection at the time he
proposes and promulgates a maximum contaminant level for each such contaminant.
The Administrator’s finding of best available
technology, treatment techniques or other
means for purposes of this subsection may
vary depending on the number of persons
served by the system or for other physical conditions related to engineering feasibility and
costs of compliance with maximum contaminant levels as considered appropriate by the
Administrator. Before a State may grant a
variance under this subparagraph, the State
must find that the variance will not result in
an unreasonable risk to health. If a State
grants a public water system a variance under
this subparagraph, the State shall prescribe at
the the 1 time the variance is granted, a schedule for—
(i) compliance (including increments of
progress) by the public water system with
each containment level requirement with respect to which the variance was granted, and
(ii) implementation by the public water
system of such additional control measures
as the State may require for each contaminant, subject to such contaminant level requirement, during the period ending on the
date compliance with such requirement is
required.
1 So

in original.

§ 300g–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Before a schedule prescribed by a State pursuant to this subparagraph may take effect, the
State shall provide notice and opportunity for
a public hearing on the schedule. A notice
given pursuant to the preceding sentence may
cover the prescribing of more than one such
schedule and a hearing held pursuant to such
notice shall include each of the schedules covered by the notice. A schedule prescribed pursuant to this subparagraph for a public water
system granted a variance shall require compliance by the system with each contaminant
level requirement with respect to which the
variance was granted as expeditiously as practicable (as the State may reasonably determine).
(B) A State which has primary enforcement
responsibility for public water systems may
grant to one or more public water systems
within its jurisdiction one or more variances
from any provision of the national primary
drinking water regulation which requires the
use of a specified treatment technique with respect to a contaminant if the public water system applying for the variance demonstrates to
the satisfaction of the State that such treatment technique is not necessary to protect the
health of persons because of the nature of the
raw water source of such system. A variance
granted under this subparagraph shall be conditioned on such monitoring and other requirements as the Administrator may prescribe.
(C) Before a variance proposed to be granted
by a State under subparagraph (A) or (B) may
take effect, such State shall provide notice
and opportunity for public hearing on the proposed variance. A notice given pursuant to the
preceding sentence may cover the granting of
more than one variance and a hearing held
pursuant to such notice shall include each of
the variances covered by the notice. The State
shall promptly notify the Administrator of all
variances granted by it. Such notification
shall contain the reason for the variance (and
in the case of a variance under subparagraph
(A), the basis for the finding required by that
subparagraph before the granting of the variance) and documentation of the need for the
variance.
(D) Each public water system’s variance
granted by a State under subparagraph (A)
shall be conditioned by the State upon compliance by the public water system with the
schedule prescribed by the State pursuant to
that subparagraph. The requirements of each
schedule prescribed by a State pursuant to
that subparagraph shall be enforceable by the
State under its laws. Any requirement of a
schedule on which a variance granted under
that subparagraph is conditioned may be enforced under section 300g–3 of this title as if
such requirement was part of a national primary drinking water regulation.
(E) Each schedule prescribed by a State pursuant to subparagraph (A) shall be deemed approved by the Administrator unless the variance for which it was prescribed is revoked by
the Administrator under subparagraph (G) or
the schedule is revised by the Administrator
under such subparagraph.

Page 984

(F) Not later than 18 months after the effective date of the interim national primary
drinking water regulations the Administrator
shall complete a comprehensive review of the
variances granted under subparagraph (A) (and
schedules prescribed pursuant thereto) and
under subparagraph (B) by the States during
the one-year period beginning on such effective date. The Administrator shall conduct
such subsequent reviews of variances and
schedules as he deems necessary to carry out
the purposes of this subchapter, but each subsequent review shall be completed within each
3-year period following the completion of the
first review under this subparagraph. Before
conducting any review under this subparagraph, the Administrator shall publish notice
of the proposed review in the Federal Register.
Such notice shall (i) provide information respecting the location of data and other information respecting the variances to be reviewed (including data and other information
concerning new scientific matters bearing on
such variances), and (ii) advise of the opportunity to submit comments on the variances
reviewed and on the need for continuing them.
Upon completion of any such review, the Administrator shall publish in the Federal Register the results of his review together with
findings responsive to comments submitted in
connection with such review.
(G)(i) If the Administrator finds that a State
has, in a substantial number of instances,
abused its discretion in granting variances
under subparagraph (A) or (B) or that in a substantial number of cases the State has failed
to prescribe schedules in accordance with subparagraph (A), the Administrator shall notify
the State of his findings. In determining if a
State has abused its discretion in granting
variances in a substantial number of instances, the Administrator shall consider the
number of persons who are affected by the
variances and if the requirements applicable
to the granting of the variances were complied
with. A notice under this clause shall—
(I) identify each public water system with
respect to which the finding was made,
(II) specify the reasons for the finding, and
(III) as appropriate, propose revocations of
specific variances or propose revised schedules or other requirements for specific public
water systems granted variances, or both.
(ii) The Administrator shall provide reasonable notice and public hearing on the provisions of each notice given pursuant to clause
(i) of this subparagraph. After a hearing on a
notice pursuant to such clause, the Administrator shall (I) rescind the finding for which
the notice was given and promptly notify the
State of such rescission, or (II) promulgate
(with such modifications as he deems appropriate) such variance revocations and revised
schedules or other requirements proposed in
such notice as he deems appropriate. Not later
than 180 days after the date a notice is given
pursuant to clause (i) of this subparagraph,
the Administrator shall complete the hearing
on the notice and take the action required by
the preceding sentence.
(iii) If a State is notified under clause (i) of
this subparagraph of a finding of the Adminis-

Page 985

TITLE 42—THE PUBLIC HEALTH AND WELFARE

trator made with respect to a variance granted a public water system within that State or
to a schedule or other requirement for a variance and if, before a revocation of such variance or a revision of such schedule or other requirement promulgated by the Administrator
takes effect, the State takes corrective action
with respect to such variance or schedule or
other requirement which the Administrator
determines makes his finding inapplicable to
such variance or schedule or other requirement, the Administrator shall rescind the application of his finding to that variance on
schedule or other requirement. No variance
revocation or revised schedule or other requirement may take effect before the expiration of 90 days following the date of the notice
in which the revocation or revised schedule or
other requirement was proposed.
(2) If a State does not have primary enforcement responsibility for public water systems,
the Administrator shall have the same authority to grant variances in such State as the
State would have under paragraph (1) if it had
primary enforcement responsibility.
(3) The Administrator may grant a variance
from any treatment technique requirement of
a national primary drinking water regulation
upon a showing by any person that an alternative treatment technique not included in
such requirement is at least as efficient in
lowering the level of the contaminant with respect to which such requirement was prescribed. A variance under this paragraph shall
be conditioned on the use of the alternative
treatment technique which is the basis of the
variance.
(b) Enforcement of schedule or other requirement
Any schedule or other requirement on which a
variance granted under paragraph (1)(B) or (2) of
subsection (a) of this section is conditioned may
be enforced under section 300g–3 of this title as
if such schedule or other requirement was part
of a national primary drinking water regulation.
(c) Applications for variances; regulations: reasonable time for acting
If an application for a variance under subsection (a) of this section is made, the State receiving the application or the Administrator, as
the case may be, shall act upon such application
within a reasonable period (as determined under
regulations prescribed by the Administrator)
after the date of its submission.
(d) ‘‘Treatment technique requirement’’ defined
For purposes of this section, the term ‘‘treatment technique requirement’’ means a requirement in a national primary drinking water regulation which specifies for a contaminant (in accordance with section 300f(1)(C)(ii) of this title)
each treatment technique known to the Administrator which leads to a reduction in the level
of such contaminant sufficient to satisfy the requirements of section 300g–1(b) of this title.
(e) Small system variances
(1) In general
A State exercising primary enforcement responsibility for public water systems under

§ 300g–4

section 300g–2 of this title (or the Administrator in nonprimacy States) may grant a
variance under this subsection for compliance
with a requirement specifying a maximum
contaminant level or treatment technique
contained in a national primary drinking
water regulation to—
(A) public water systems serving 3,300 or
fewer persons; and
(B) with the approval of the Administrator
pursuant to paragraph (9), public water systems serving more than 3,300 persons but
fewer than 10,000 persons,
if the variance meets each requirement of this
subsection.
(2) Availability of variances
A public water system may receive a variance pursuant to paragraph (1), if—
(A) the Administrator has identified a
variance
technology
under
section
300g–1(b)(15) of this title that is applicable to
the size and source water quality conditions
of the public water system;
(B) the public water system installs, operates, and maintains, in accordance with
guidance or regulations issued by the Administrator, such treatment technology,
treatment technique, or other means; and
(C) the State in which the system is located determines that the conditions of
paragraph (3) are met.
(3) Conditions for granting variances
A variance under this subsection shall be
available only to a system—
(A) that cannot afford to comply, in accordance with affordability criteria established by the Administrator (or the State in
the case of a State that has primary enforcement responsibility under section 300g–2 of
this title), with a national primary drinking
water regulation, including compliance
through—
(i) treatment;
(ii) alternative source of water supply; or
(iii) restructuring or consolidation (unless the Administrator (or the State in the
case of a State that has primary enforcement responsibility under section 300g–2 of
this title) makes a written determination
that restructuring or consolidation is not
practicable); and
(B) for which the Administrator (or the
State in the case of a State that has primary
enforcement responsibility under section
300g–2 of this title) determines that the
terms of the variance ensure adequate protection of human health, considering the
quality of the source water for the system
and the removal efficiencies and expected
useful life of the treatment technology required by the variance.
(4) Compliance schedules
A variance granted under this subsection
shall require compliance with the conditions
of the variance not later than 3 years after the
date on which the variance is granted, except
that the Administrator (or the State in the
case of a State that has primary enforcement

§ 300g–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

responsibility under section 300g–2 of this
title) may allow up to 2 additional years to
comply with a variance technology, secure an
alternative source of water, restructure or
consolidate if the Administrator (or the State)
determines that additional time is necessary
for capital improvements, or to allow for financial assistance provided pursuant to section 300j–12 of this title or any other Federal
or State program.
(5) Duration of variances
The Administrator (or the State in the case
of a State that has primary enforcement responsibility under section 300g–2 of this title)
shall review each variance granted under this
subsection not less often than every 5 years
after the compliance date established in the
variance to determine whether the system remains eligible for the variance and is conforming to each condition of the variance.
(6) Ineligibility for variances
A variance shall not be available under this
subsection for—
(A) any maximum contaminant level or
treatment technique for a contaminant with
respect to which a national primary drinking water regulation was promulgated prior
to January 1, 1986; or
(B) a national primary drinking water regulation for a microbial contaminant (including a bacterium, virus, or other organism) or
an indicator or treatment technique for a
microbial contaminant.
(7) Regulations and guidance
(A) In general
Not later than 2 years after August 6, 1996,
and in consultation with the States, the Administrator shall promulgate regulations for
variances to be granted under this subsection. The regulations shall, at a minimum, specify—
(i) procedures to be used by the Administrator or a State to grant or deny variances, including requirements for notifying the Administrator and consumers of
the public water system that a variance is
proposed to be granted (including information regarding the contaminant and variance) and requirements for a public hearing on the variance before the variance is
granted;
(ii) requirements for the installation and
proper operation of variance technology
that is identified (pursuant to section
300g–1(b)(15) of this title) for small systems
and the financial and technical capability
to operate the treatment system, including operator training and certification;
(iii) eligibility criteria for a variance for
each national primary drinking water regulation, including requirements for the
quality of the source water (pursuant to
section 300g–1(b)(15)(A) of this title); and
(iv) information requirements for variance applications.
(B) Affordability criteria
Not later than 18 months after August 6,
1996, the Administrator, in consultation with

Page 986

the States and the Rural Utilities Service of
the Department of Agriculture, shall publish
information to assist the States in developing affordability criteria. The affordability
criteria shall be reviewed by the States not
less often than every 5 years to determine if
changes are needed to the criteria.
(8) Review by the Administrator
(A) In general
The Administrator shall periodically review the program of each State that has primary enforcement responsibility for public
water systems under section 300g–2 of this
title with respect to variances to determine
whether the variances granted by the State
comply with the requirements of this subsection. With respect to affordability, the
determination of the Administrator shall be
limited to whether the variances granted by
the State comply with the affordability criteria developed by the State.
(B) Notice and publication
If the Administrator determines that variances granted by a State are not in compliance with affordability criteria developed by
the State and the requirements of this subsection, the Administrator shall notify the
State in writing of the deficiencies and
make public the determination.
(9) Approval of variances
A State proposing to grant a variance under
this subsection to a public water system serving more than 3,300 and fewer than 10,000 persons shall submit the variance to the Administrator for review and approval prior to the issuance of the variance. The Administrator
shall approve the variance if it meets each of
the requirements of this subsection. The Administrator shall approve or disapprove the
variance within 90 days. If the Administrator
disapproves a variance under this paragraph,
the Administrator shall notify the State in
writing of the reasons for disapproval and the
variance may be resubmitted with modifications to address the objections stated by the
Administrator.
(10) Objections to variances
(A) By the Administrator
The Administrator may review and object
to any variance proposed to be granted by a
State, if the objection is communicated to
the State not later than 90 days after the
State proposes to grant the variance. If the
Administrator objects to the granting of a
variance, the Administrator shall notify the
State in writing of each basis for the objection and propose a modification to the variance to resolve the concerns of the Administrator. The State shall make the recommended modification or respond in writing to each objection. If the State issues the
variance without resolving the concerns of
the Administrator, the Administrator may
overturn the State decision to grant the
variance if the Administrator determines
that the State decision does not comply with
this subsection.

Page 987

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Petition by consumers
Not later than 30 days after a State exercising primary enforcement responsibility
for public water systems under section
300g–2 of this title proposes to grant a variance for a public water system, any person
served by the system may petition the Administrator to object to the granting of a
variance. The Administrator shall respond
to the petition and determine whether to object to the variance under subparagraph (A)
not later than 60 days after the receipt of
the petition.
(C) Timing
No variance shall be granted by a State
until the later of the following:
(i) 90 days after the State proposes to
grant a variance.
(ii) If the Administrator objects to the
variance, the date on which the State
makes the recommended modifications or
responds in writing to each objection.
(July 1, 1944, ch. 373, title XIV, § 1415, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1669;
amended Pub. L. 99–339, title I, § 104, June 19,
1986, 100 Stat. 649; Pub. L. 104–182, title I,
§§ 102(c)(1), 115, 116, title V, § 501(a)(3), Aug. 6,
1996, 110 Stat. 1621, 1641, 1691.)
AMENDMENTS
1996—Subsec. (a)(1)(A). Pub. L. 104–182, § 501(a)(3), inserted ‘‘the’’ before ‘‘time the variance is granted,’’ in
introductory provisions.
Pub. L. 104–182, § 115, in second sentence, substituted
‘‘be issued to a system on condition that the system install’’ for ‘‘only be issued to a system after the system’s application of’’ and inserted ‘‘, and based upon an
evaluation satisfactory to the State that indicates that
alternative sources of water are not reasonably available to the system’’ after ‘‘(taking costs into consideration)’’.
Subsec. (d). Pub. L. 104–182, § 102(c)(1), substituted
‘‘section 300g–1(b)’’ for ‘‘section 300g–1(b)(3)’’.
Subsec. (e). Pub. L. 104–182, § 116, added subsec. (e).
1986—Subsec. (a)(1)(A). Pub. L. 99–339, § 104(1)–(3), substituted ‘‘such drinking water regulation. A variance
may only be issued to a system after the system’s application’’ for ‘‘such drinking water regulation despite
application’’, struck out ‘‘generally’’ after ‘‘finds are’’,
inserted provisions relating to proposal and promulgation by Administrator of a finding on best available
technology, treatment techniques or other means
available for each contaminant at time of proposal and
promulgation of maximum contaminant levels, and
substituted ‘‘at the time’’ for ‘‘within one year of the
date’’.
Subsec. (a)(1)(A)(ii). Pub. L. 99–339, § 104(4), substituted ‘‘water system of such additional control’’ for
‘‘water system of such control’’.

§ 300g–5. Exemptions
(a) Requisite findings
A State which has primary enforcement responsibility may exempt any public water system within the State’s jurisdiction from any requirement respecting a maximum contaminant
level or any treatment technique requirement,
or from both, of an applicable national primary
drinking water regulation upon a finding that—
(1) due to compelling factors (which may include economic factors, including qualification of the public water system as a system

§ 300g–5

serving a disadvantaged community pursuant
to section 300j–12(d) of this title), the public
water system is unable to comply with such
contaminant level or treatment technique requirement, or to implement measures to develop an alternative source of water supply,
(2) the public water system was in operation
on the effective date of such contaminant
level or treatment technique requirement, or,
for a system that was not in operation by that
date, only if no reasonable alternative source
of drinking water is available to such new system,
(3) the granting of the exemption will not result in an unreasonable risk to health; 1 and
(4) management or restructuring changes (or
both) cannot reasonably be made that will result in compliance with this subchapter or, if
compliance cannot be achieved, improve the
quality of the drinking water.
(b) Compliance schedule and implementation of
control measures; notice and hearing; dates
for compliance with schedule; compliance,
enforcement; approval or revision of schedules and revocation of exemptions
(1) If a State grants a public water system an
exemption under subsection (a) of this section,
the State shall prescribe, at the time the exemption is granted, a schedule for—
(A) compliance (including increments of
progress or measures to develop an alternative
source of water supply) by the public water
system with each contaminant level requirement or treatment technique requirement
with respect to which the exemption was
granted, and
(B) implementation by the public water system of such control measures as the State
may require for each contaminant, subject to
such contaminant level requirement or treatment technique requirement, during the period ending on the date compliance with such
requirement is required.
Before a schedule prescribed by a State pursuant
to this subsection may take effect, the State
shall provide notice and opportunity for a public
hearing on the schedule. A notice given pursuant to the preceding sentence may cover the
prescribing of more than one such schedule and
a hearing held pursuant to such notice shall include each of the schedules covered by the notice.
(2)(A) A schedule prescribed pursuant to this
subsection for a public water system granted an
exemption under subsection (a) of this section
shall require compliance by the system with
each contaminant level and treatment technique requirement with respect to which the exemption was granted as expeditiously as practicable (as the State may reasonably determine)
but not later than 3 years after the otherwise
applicable compliance date established in section 300g–1(b)(10) of this title.
(B) No exemption shall be granted unless the
public water system establishes that—
(i) the system cannot meet the standard
without capital improvements which cannot
be completed prior to the date established pursuant to section 300g–1(b)(10) of this title;
1 So

in original. The semicolon probably should be a comma.

§ 300g–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) in the case of a system which needs financial assistance for the necessary improvements, the system has entered into an agreement to obtain such financial assistance or assistance pursuant to section 300j–12 of this
title, or any other Federal or State program is
reasonably likely to be available within the
period of the exemption; or
(iii) the system has entered into an enforceable agreement to become a part of a regional
public water system; and
the system is taking all practicable steps to
meet the standard.
(C) In the case of a system which does not
serve more than a population of 3,300 and which
needs financial assistance for the necessary improvements, an exemption granted under clause
(i) or (ii) of subparagraph (B) may be renewed for
one or more additional 2-year periods, but not to
exceed a total of 6 years, if the system establishes that it is taking all practicable steps to
meet the requirements of subparagraph (B).
(D) LIMITATION.—A public water system may
not receive an exemption under this section if
the system was granted a variance under section
300g–4(e) of this title.
(3) Each public water system’s exemption
granted by a State under subsection (a) of this
section shall be conditioned by the State upon
compliance by the public water system with the
schedule prescribed by the State pursuant to
this subsection. The requirements of each schedule prescribed by a State pursuant to this subsection shall be enforceable by the State under
its laws. Any requirement of a schedule on
which an exemption granted under this section
is conditioned may be enforced under section
300g–3 of this title as if such requirement was
part of a national primary drinking water regulation.
(4) Each schedule prescribed by a State pursuant to this subsection shall be deemed approved
by the Administrator unless the exemption for
which it was prescribed is revoked by the Administrator under subsection (d)(2) of this section or the schedule is revised by the Administrator under such subsection.
(c) Notice to Administrator; reasons for exemption
Each State which grants an exemption under
subsection (a) of this section shall promptly notify the Administrator of the granting of such
exemption. Such notification shall contain the
reasons for the exemption (including the basis
for the finding required by subsection (a)(3) of
this section before the exemption may be granted) and document the need for the exemption.
(d) Review of exemptions and schedules; publication in Federal Register, notice and results of
review; notice to State; considerations respecting abuse of discretion in granting exemptions or failing to prescribe schedules;
State corrective action
(1) Not later than 18 months after the effective
date of the interim national primary drinking
water regulations the Administrator shall complete a comprehensive review of the exemptions
granted (and schedules prescribed pursuant
thereto) by the States during the one-year pe-

Page 988

riod beginning on such effective date. The Administrator shall conduct such subsequent reviews of exemptions and schedules as he deems
necessary to carry out the purposes of this subchapter, but each subsequent review shall be
completed within each 3-year period following
the completion of the first review under this
subparagraph. Before conducting any review
under this subparagraph, the Administrator
shall publish notice of the proposed review in
the Federal Register. Such notice shall (A) provide information respecting the location of data
and other information respecting the exemptions to be reviewed (including data and other
information concerning new scientific matters
bearing on such exemptions), and (B) advise of
the opportunity to submit comments on the exemptions reviewed and on the need for continuing them. Upon completion of any such review,
the Administrator shall publish in the Federal
Register the results of his review, together with
findings responsive to comments submitted in
connection with such review.
(2)(A) If the Administrator finds that a State
has, in a substantial number of instances,
abused its discretion in granting exemptions
under subsection (a) of this section or failed to
prescribe schedules in accordance with subsection (b) of this section, the Administrator
shall notify the State of his findings. In determining if a State has abused its discretion in
granting exemptions in a substantial number of
instances, the Administrator shall consider the
number of persons who are affected by the exemptions and if the requirements applicable to
the granting of the exemptions were complied
with. A notice under this subparagraph shall—
(i) identify each exempt public water system
with respect to which the finding was made,
(ii) specify the reasons for the finding, and
(iii) as appropriate, propose revocations of
specific exemptions or propose revised schedules for specific exempt public water systems,
or both.
(B) The Administrator shall provide reasonable notice and public hearing on the provisions
of each notice given pursuant to subparagraph
(A). After a hearing on notice pursuant to subparagraph (A), the Administrator shall (i) rescind the finding for which the notice was given
and promptly notify the State of such rescission, or (ii) promulgate (with such modifications
as he deems appropriate) such exemption revocations and revised schedules proposed in such
notice as he deems appropriate. Not later than
180 days after the date a notice is given pursuant
to subparagraph (A), the Administrator shall
complete the hearing on the notice and take the
action required by the preceding sentence.
(C) If a State is notified under subparagraph
(A) of a finding of the Administrator made with
respect to an exemption granted a public water
system within that State or to a schedule prescribed pursuant to such an exemption and if before a revocation of such exemption or a revision of such schedule promulgated by the Administrator takes effect the State takes corrective action with respect to such exemption or
schedule which the Administrator determines
makes his finding inapplicable to such exemption or schedule, the Administrator shall re-

Page 989

TITLE 42—THE PUBLIC HEALTH AND WELFARE

scind the application of his finding to that exemption or schedule. No exemption revocation
or revised schedule may take effect before the
expiration of 90 days following the date of the
notice in which the revocation or revised schedule was proposed.
(e) ‘‘Treatment technique requirement’’ defined
For purposes of this section, the term ‘‘treatment technique requirement’’ means a requirement in a national primary drinking water regulation which specifies for a contaminant (in accordance with section 300f(1)(C)(ii) of this title)
each treatment technique known to the Administrator which leads to a reduction in the level
of such contaminant sufficient to satisfy the requirements of section 300g–1(b) of this title.
(f) Authority of Administrator in a State without
primary enforcement responsibility
If a State does not have primary enforcement
responsibility for public water systems, the Administrator shall have the same authority to exempt public water systems in such State from
maximum contaminant level requirements and
treatment technique requirements under the
same conditions and in the same manner as the
State would be authorized to grant exemptions
under this section if it had primary enforcement
responsibility.
(g) Applications for exemptions; regulations; reasonable time for acting
If an application for an exemption under this
section is made, the State receiving the application or the Administrator, as the case may be,
shall act upon such application within a reasonable period (as determined under regulations
prescribed by the Administrator) after the date
of its submission.
(July 1, 1944, ch. 373, title XIV, § 1416, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1672;
amended Pub. L. 95–190, § 10(a), Nov. 16, 1977, 91
Stat. 1398; Pub. L. 96–502, §§ 1, 4(b), Dec. 5, 1980,
94 Stat. 2737, 2738; Pub. L. 99–339, title I,
§§ 101(c)(4), 105, June 19, 1986, 100 Stat. 646, 649;
Pub. L. 104–182, title I, § 117(a), Aug. 6, 1996, 110
Stat. 1644.)
AMENDMENTS
1996—Subsec. (a)(1). Pub. L. 104–182, § 117(a)(1), inserted ‘‘, including qualification of the public water
system as a system serving a disadvantaged community pursuant to section 300j–12(d) of this title’’ after
‘‘(which may include economic factors’’ and ‘‘or to implement measures to develop an alternative source of
water supply,’’ after ‘‘treatment technique requirement,’’.
Subsec. (a)(4). Pub. L. 104–182, § 117(a)(2), added par.
(4).
Subsec. (b)(1)(A). Pub. L. 104–182, § 117(a)(3), substituted ‘‘(including increments of progress or measures to develop an alternative source of water supply)’’
for ‘‘(including increments of progress)’’ and ‘‘requirement or treatment’’ for ‘‘requirement and treatment’’.
Subsec. (b)(2)(A). Pub. L. 104–182, § 117(a)(4)(A), substituted ‘‘not later than 3 years after the otherwise applicable compliance date established in section
300g–1(b)(10) of this title.’’ for ‘‘(except as provided in
subparagraph (B))—
‘‘(i) in the case of an exemption granted with respect to a contaminant level or treatment technique
requirement prescribed by the national primary
drinking water regulations promulgated under sec-

§ 300g–5

tion 300g–1(a) of this title, not later than 12 months
after June 19, 1986; and
‘‘(ii) in the case of an exemption granted with respect to a contaminant level or treatment technique
requirement prescribed by national primary drinking
water regulations, other than a regulation referred to
in section 300g–1(a) of this title, 12 months after the
date of the issuance of the exemption.’’
Subsec. (b)(2)(B). Pub. L. 104–182, § 117(a)(4)(A), substituted ‘‘No exemption shall be granted unless’’ for
‘‘The final date for compliance provided in any schedule in the case of any exemption may be extended by
the State (in the case of a State which has primary enforcement responsibility) or by the Administrator (in
any other case) for a period not to exceed 3 years after
the date of the issuance of the exemption if’’ in introductory provisions.
Subsec. (b)(2)(B)(i). Pub. L. 104–182, § 117(a)(4)(B), substituted ‘‘prior to the date established pursuant to section 300g–1(b)(10) of this title’’ for ‘‘within the period of
such exemption’’.
Subsec. (b)(2)(B)(ii). Pub. L. 104–182, § 117(a)(4)(C), inserted ‘‘or assistance pursuant to section 300j–12 of this
title, or any other Federal or State program is reasonably likely to be available within the period of the exemption’’ after ‘‘such financial assistance’’.
Subsec. (b)(2)(C). Pub. L. 104–182, § 117(a)(4)(D), substituted ‘‘a population of 3,300’’ for ‘‘500 service connections’’ and inserted ‘‘, but not to exceed a total of 6
years,’’ after ‘‘for one or more additional 2-year periods’’.
Subsec. (b)(2)(D). Pub. L. 104–182, § 117(a)(4)(E), added
subpar. (D).
1986—Subsec. (b)(1). Pub. L. 99–339, § 105(a)(1), substituted ‘‘at the time’’ for ‘‘within one year of the
date’’.
Subsec. (b)(2)(A)(i). Pub. L. 99–339, § 105(a)(2), struck
out ‘‘interim’’ before ‘‘national primary’’ and substituted ‘‘not later than 12 months after June 19, 1986’’
for ‘‘not later than January 1, 1984’’.
Subsec. (b)(2)(A)(ii). Pub. L. 99–339, § 105(a)(3), struck
out ‘‘revised’’ before ‘‘national primary’’ and substituted ‘‘other than a regulation referred to in section
300g–1(a) of this title, 12 months after the date of the issuance of the exemption’’ for ‘‘not later than seven
years after the date such requirement takes effect’’.
Subsec. (b)(2)(B). Pub. L. 99–339, § 105(a)(4), amended
subpar. (B) generally. Prior to amendment, subpar. (B)
read as follows: ‘‘Notwithstanding clauses (i) and (ii) of
subparagraph (A) of this paragraph, the final date for
compliance prescribed in a schedule prescribed pursuant to this subsection for an exemption granted for a
public water system which (as determined by the State
granting the exemption) has entered into an enforceable agreement to become a part of a regional public
water system shall—
‘‘(i) in the case of a schedule prescribed for an exemption granted with respect to a contaminant level
or treatment technique requirement prescribed by interim national primary drinking water regulations,
be not later than January 1, 1986; and
‘‘(ii) in the case of a schedule prescribed for an exemption granted with respect to a contaminant level
or treatment technique requirement prescribed by revised national primary drinking water regulations, be
not later than nine years after such requirement
takes effect.’’
Subsec. (b)(2)(C). Pub. L. 99–339, § 105(a)(4), added subpar. (C).
Subsec. (e). Pub. L. 99–339, § 101(c)(4), substituted
‘‘300g–1(b)’’ for ‘‘300g–1(b)(3)’’.
1980—Subsec. (a)(2). Pub. L. 96–502, § 4(b), substituted
‘‘treatment technique requirement, or, for a system
that was not in operation by that date, only if no reasonable alternative source of drinking water is available to such new system, and’’ for ‘‘treatment technique requirement, and’’.
Subsec. (b)(2)(A)(i). Pub. L. 96–502, § 1, substituted
‘‘January 1, 1984’’ for ‘‘January 1, 1981’’.
Subsec. (b)(2)(B)(i). Pub. L. 96–502, § 1, substituted
‘‘January 1, 1986’’ for ‘‘January 1, 1983’’.

§ 300g–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1977—Subsec. (b)(1). Pub. L. 95–190 substituted ‘‘contaminant’’ for ‘‘containment’’ wherever appearing.

§ 300g–6. Prohibition on use of lead pipes, solder,
and flux
(a) In general
(1) Prohibitions
(A) In general
No person may use any pipe, any pipe or
plumbing fitting or fixture, any solder, or
any flux, after June 19, 1986, in the installation or repair of—
(i) any public water system; or
(ii) any plumbing in a residential or nonresidential facility providing water for
human consumption,
that is not lead free (within the meaning of
subsection (d) of this section).
(B) Leaded joints
Subparagraph (A) shall not apply to leaded
joints necessary for the repair of cast iron
pipes.
(2) Public notice requirements
(A) In general
Each owner or operator of a public water
system shall identify and provide notice to
persons that may be affected by lead contamination of their drinking water where
such contamination results from either or
both of the following:
(i) The lead content in the construction
materials of the public water distribution
system.
(ii) Corrosivity of the water supply sufficient to cause leaching of lead.
The notice shall be provided in such manner
and form as may be reasonably required by
the Administrator. Notice under this paragraph shall be provided notwithstanding the
absence of a violation of any national drinking water standard.
(B) Contents of notice
Notice under this paragraph shall provide
a clear and readily understandable explanation of—
(i) the potential sources of lead in the
drinking water,
(ii) potential adverse health effects,
(iii) reasonably available methods of
mitigating known or potential lead content in drinking water,
(iv) any steps the system is taking to
mitigate lead content in drinking water,
and
(v) the necessity for seeking alternative
water supplies, if any.
(3) Unlawful acts
Effective 2 years after August 6, 1996, it shall
be unlawful—
(A) for any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except
for a pipe that is used in manufacturing or
industrial processing;
(B) for any person engaged in the business
of selling plumbing supplies, except manu-

Page 990

facturers, to sell solder or flux that is not
lead free; or
(C) for any person to introduce into commerce any solder or flux that is not lead free
unless the solder or flux bears a prominent
label stating that it is illegal to use the solder or flux in the installation or repair of
any plumbing providing water for human
consumption.
(b) State enforcement
(1) Enforcement of prohibition
The requirements of subsection (a)(1) of this
section shall be enforced in all States effective
24 months after June 19, 1986. States shall enforce such requirements through State or
local plumbing codes, or such other means of
enforcement as the State may determine to be
appropriate.
(2) Enforcement of public notice requirements
The requirements of subsection (a)(2) of this
section shall apply in all States effective 24
months after June 19, 1986.
(c) Penalties
If the Administrator determines that a State
is not enforcing the requirements of subsection
(a) of this section as required pursuant to subsection (b) of this section, the Administrator
may withhold up to 5 percent of Federal funds
available to that State for State program grants
under section 300j–2(a) of this title.
(d) ‘‘Lead free’’ defined
For purposes of this section, the term ‘‘lead
free’’—
(1) when used with respect to solders and
flux refers to solders and flux containing not
more than 0.2 percent lead;
(2) when used with respect to pipes and pipe
fittings refers to pipes and pipe fittings containing not more than 8.0 percent lead; and
(3) when used with respect to plumbing fittings and fixtures, refers to plumbing fittings
and fixtures in compliance with standards established in accordance with subsection (e) of
this section.
(e) Plumbing fittings and fixtures
(1) In general
The Administrator shall provide accurate
and timely technical information and assistance to qualified third-party certifiers in the
development of voluntary standards and testing protocols for the leaching of lead from new
plumbing fittings and fixtures that are intended by the manufacturer to dispense water
for human ingestion.
(2) Standards
(A) In general
If a voluntary standard for the leaching of
lead is not established by the date that is 1
year after August 6, 1996, the Administrator
shall, not later than 2 years after August 6,
1996, promulgate regulations setting a
health-effects-based performance standard
establishing maximum leaching levels from
new plumbing fittings and fixtures that are
intended by the manufacturer to dispense
water for human ingestion. The standard

Page 991

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall become effective on the date that is 5
years after the date of promulgation of the
standard.
(B) Alternative requirement
If regulations are required to be promulgated under subparagraph (A) and have not
been promulgated by the date that is 5 years
after August 6, 1996, no person may import,
manufacture, process, or distribute in commerce a new plumbing fitting or fixture, intended by the manufacturer to dispense
water for human ingestion, that contains
more than 4 percent lead by dry weight.
(July 1, 1944, ch. 373, title XIV, § 1417, as added
Pub. L. 99–339, title I, § 109(a), June 19, 1986, 100
Stat. 651; amended Pub. L. 104–182, title I, § 118,
title V, § 501(f)(1), Aug. 6, 1996, 110 Stat. 1645, 1691;
Pub. L. 111–380, § 2(a), Jan. 4, 2011, 124 Stat. 4131.)
AMENDMENT OF SUBSECTIONS (a) AND (d)
Pub. L. 111–380, § 2, Jan. 4, 2011, 124 Stat.
4131, provided that, applicable beginning on the
day that is 36 months after Jan. 4, 2011, this
section is amended as follows:
(1) by adding at the end of subsection (a) the
following:
‘‘(4) Exemptions
‘‘The prohibitions in paragraphs (1) and (3)
shall not apply to—
‘‘(A) pipes, pipe fittings, plumbing fittings, or
fixtures, including backflow preventers, that
are used exclusively for nonpotable services
such as manufacturing, industrial processing,
irrigation, outdoor watering, or any other uses
where the water is not anticipated to be used
for human consumption; or
‘‘(B) toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service
saddles, or water distribution main gate valves
that are 2 inches in diameter or larger.’’; and
(2) by amending subsection (d) to read as follows:
(d) Definition of lead free
(1) In general
For the purposes of this section, the term ‘‘lead
free’’ means—
(A) not containing more than 0.2 percent lead
when used with respect to solder and flux; and
(B) not more than a weighted average of 0.25
percent lead when used with respect to the
wetted surfaces of pipes, pipe fittings, plumbing
fittings, and fixtures.
(2) Calculation
The weighted average lead content of a pipe,
pipe fitting, plumbing fitting, or fixture shall be
calculated by using the following formula: For
each wetted component, the percentage of lead in
the component shall be multiplied by the ratio of
the wetted surface area of that component to the
total wetted surface area of the entire product to
arrive at the weighted percentage of lead of the
component. The weighted percentage of lead of
each wetted component shall be added together,
and the sum of these weighted percentages shall
constitute the weighted average lead content of
the product. The lead content of the material used
to produce wetted components shall be used to de-

§ 300g–7

termine compliance with paragraph (1)(B). For
lead content of materials that are provided as a
range, the maximum content of the range shall be
used.
AMENDMENTS
1996—Pub. L. 104–182, § 501(f)(1), made technical
amendment to section catchline and subsec. (a) designation.
Subsec. (a)(1). Pub. L. 104–182, § 118(1), substituted
‘‘Prohibitions’’ for ‘‘Prohibition’’ in heading and
amended text generally. Prior to amendment, text read
as follows: ‘‘Any pipe, solder, or flux, which is used
after June 19, 1986, in the installation or repair of—
‘‘(A) any public water system, or
‘‘(B) any plumbing in a residential or nonresidential facility providing water for human consumption
which is connected to a public water system,
shall be lead free (within the meaning of subsection (d)
of this section). This paragraph shall not apply to leaded joints necessary for the repair of cast iron pipes.’’
Subsec. (a)(2)(A). Pub. L. 104–182, § 118(2), inserted
‘‘owner or operator of a’’ after ‘‘Each’’ in introductory
provisions.
Subsec. (a)(3). Pub. L. 104–182, § 118(3), added par. (3).
Subsec. (d)(3). Pub. L. 104–182, § 118(4), added par. (3).
Subsec. (e). Pub. L. 104–182, § 118(5), added subsec. (e).
EFFECTIVE DATE OF 2011 AMENDMENT
Pub. L. 111–380, § 2(b), Jan. 4, 2011, 124 Stat. 4132, provided that: ‘‘The provisions of subsections (a)(4) and (d)
of section 1417 of the Safe Drinking Water Act [42
U.S.C. 300g–6(a)(4), (d)], as added by this section, apply
beginning on the day that is 36 months after the date
of the enactment of this Act [Jan. 4, 2011].’’
NOTIFICATION TO STATES
Section 109(b) of Pub. L. 99–339 provided that: ‘‘The
Administrator of the Environmental Protection Agency shall notify all States with respect to the requirements of section 1417 of the Public Health Service Act
[this section] within 90 days after the enactment of this
Act [June 19, 1986].’’
BAN ON LEAD WATER PIPES, SOLDER, AND FLUX IN VA
AND HUD INSURED OR ASSISTED PROPERTY
Section 109(c) of Pub. L. 99–339, as amended by Pub.
L. 102–54, § 13(q)(2), June 13, 1991, 105 Stat. 279, provided
that:
‘‘(1) PROHIBITION.—The Secretary of Housing and
Urban Development and the Secretary of Veterans Affairs may not insure or guarantee a mortgage or furnish assistance with respect to newly constructed residential property which contains a potable water system
unless such system uses only lead free pipe, solder, and
flux.
‘‘(2) DEFINITION OF LEAD FREE.—For purposes of paragraph (1) the term ‘lead free’—
‘‘(A) when used with respect to solders and flux refers to solders and flux containing not more than 0.2
percent lead, and
‘‘(B) when used with respect to pipes and pipe fittings refers to pipes and pipe fittings containing not
more than 8.0 percent lead.
‘‘(3) EFFECTIVE DATE.—Paragraph (1) shall become effective 24 months after the enactment of this Act [June
19, 1986].’’

§ 300g–7. Monitoring of contaminants
(a) Interim monitoring relief authority
(1) In general
A State exercising primary enforcement responsibility for public water systems may
modify the monitoring requirements for any
regulated or unregulated contaminants for
which monitoring is required other than mi-

§ 300g–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

crobial contaminants (or indicators thereof),
disinfectants and disinfection byproducts or
corrosion byproducts for an interim period to
provide that any public water system serving
10,000 persons or fewer shall not be required to
conduct additional quarterly monitoring during an interim relief period for such contaminants if—
(A) monitoring, conducted at the beginning of the period for the contaminant concerned and certified to the State by the public water system, fails to detect the presence
of the contaminant in the ground or surface
water supplying the public water system;
and
(B) the State, considering the hydrogeology of the area and other relevant factors, determines in writing that the contaminant is unlikely to be detected by further monitoring during such period.
(2) Termination; timing of monitoring
The interim relief period referred to in paragraph (1) shall terminate when permanent
monitoring relief is adopted and approved for
such State, or at the end of 36 months after
August 6, 1996, whichever comes first. In order
to serve as a basis for interim relief, the monitoring conducted at the beginning of the period must occur at the time determined by the
State to be the time of the public water system’s greatest vulnerability to the contaminant concerned in the relevant ground or surface water, taking into account in the case of
pesticides the time of application of the pesticide for the source water area and the travel
time for the pesticide to reach such waters
and taking into account, in the case of other
contaminants, seasonality of precipitation and
contaminant travel time.
(b) Permanent monitoring relief authority
(1) In general
Each State exercising primary enforcement
responsibility for public water systems under
this subchapter and having an approved source
water assessment program may adopt, in accordance with guidance published by the Administrator, tailored alternative monitoring
requirements for public water systems in such
State (as an alternative to the monitoring requirements for chemical contaminants set
forth in the applicable national primary
drinking water regulations) where the State
concludes that (based on data available at the
time of adoption concerning susceptibility,
use, occurrence, or wellhead protection, or
from the State’s drinking water source water
assessment program) such alternative monitoring would provide assurance that it complies with the Administrator’s guidelines. The
State program must be adequate to assure
compliance with, and enforcement of, applicable national primary drinking water regulations. Alternative monitoring shall not apply
to regulated microbiological contaminants (or
indicators thereof), disinfectants and disinfection byproducts, or corrosion byproducts. The
preceding sentence is not intended to limit
other authority of the Administrator under
other provisions of this subchapter to grant
monitoring flexibility.

Page 992

(2) Guidelines
(A) In general
The Administrator shall issue, after notice
and comment and at the same time as guidelines are issued for source water assessment
under section 300j–13 of this title, guidelines
for States to follow in proposing alternative
monitoring requirements under paragraph
(1) for chemical contaminants. The Administrator shall publish such guidelines in the
Federal Register. The guidelines shall assure
that the public health will be protected from
drinking water contamination. The guidelines shall require that a State alternative
monitoring program apply on a contaminant-by-contaminant basis and that, to be
eligible for such alternative monitoring program, a public water system must show the
State that the contaminant is not present in
the drinking water supply or, if present, it is
reliably and consistently below the maximum contaminant level.
(B) Definition
For purposes of subparagraph (A), the
phrase ‘‘reliably and consistently below the
maximum contaminant level’’ means that,
although contaminants have been detected
in a water supply, the State has sufficient
knowledge of the contamination source and
extent of contamination to predict that the
maximum contaminant level will not be exceeded. In determining that a contaminant
is reliably and consistently below the maximum contaminant level, States shall consider the quality and completeness of data,
the length of time covered and the volatility
or stability of monitoring results during
that time, and the proximity of such results
to the maximum contaminant level. Wide
variations in the analytical results, or analytical results close to the maximum contaminant level, shall not be considered to be
reliably and consistently below the maximum contaminant level.
(3) Effect of detection of contaminants
The guidelines issued by the Administrator
under paragraph (2) shall require that if, after
the monitoring program is in effect and operating, a contaminant covered by the alternative monitoring program is detected at levels at or above the maximum contaminant
level or is no longer reliably or consistently
below the maximum contaminant level, the
public water system must either—
(A) demonstrate that the contamination
source has been removed or that other action has been taken to eliminate the contamination problem; or
(B) test for the detected contaminant pursuant to the applicable national primary
drinking water regulation.
(4) States not exercising primary enforcement
responsibility
The Governor of any State not exercising
primary enforcement responsibility under section 300g–2 of this title on August 6, 1996, may
submit to the Administrator a request that
the Administrator modify the monitoring re-

Page 993

TITLE 42—THE PUBLIC HEALTH AND WELFARE

quirements established by the Administrator
and applicable to public water systems in that
State. After consultation with the Governor,
the Administrator shall modify the requirements for public water systems in that State
if the request of the Governor is in accordance
with each of the requirements of this subsection that apply to alternative monitoring
requirements established by States that have
primary enforcement responsibility. A decision by the Administrator to approve a request under this clause shall be for a period of
3 years and may subsequently be extended for
periods of 5 years.
(c) Treatment as NPDWR
All monitoring relief granted by a State to a
public water system for a regulated contaminant under subsection (a) or (b) of this section
shall be treated as part of the national primary
drinking water regulation for that contaminant.
(d) Other monitoring relief
Nothing in this section shall be construed to
affect the authority of the States under applicable national primary drinking water regulations
to alter monitoring requirements through waivers or other existing authorities. The Administrator shall periodically review and, as appropriate, revise such authorities.
(July 1, 1944, ch. 373, title XIV, § 1418, as added
Pub. L. 104–182, title I, § 125(b), Aug. 6, 1996, 110
Stat. 1654.)
§ 300g–8. Operator certification
(a) Guidelines
Not later than 30 months after August 6, 1996,
and in cooperation with the States, the Administrator shall publish guidelines in the Federal
Register, after notice and opportunity for comment from interested persons, including States
and public water systems, specifying minimum
standards for certification (and recertification)
of the operators of community and nontransient
noncommunity public water systems. Such
guidelines shall take into account existing State
programs, the complexity of the system, and
other factors aimed at providing an effective
program at reasonable cost to States and public
water systems, taking into account the size of
the system.
(b) State programs
Beginning 2 years after the date on which the
Administrator publishes guidelines under subsection (a) of this section, the Administrator
shall withhold 20 percent of the funds a State is
otherwise entitled to receive under section
300j–12 of this title unless the State has adopted
and is implementing a program for the certification of operators of community and nontransient noncommunity public water systems that
meets the requirements of the guidelines published pursuant to subsection (a) of this section
or that has been submitted in compliance with
subsection (c) of this section and that has not
been disapproved.
(c) Existing programs
For any State exercising primary enforcement
responsibility for public water systems or any

§ 300g–8

other State which has an operator certification
program, the guidelines under subsection (a) of
this section shall allow the State to enforce
such program in lieu of the guidelines under
subsection (a) of this section if the State submits the program to the Administrator within 18
months after the publication of the guidelines
unless the Administrator determines (within 9
months after the State submits the program to
the Administrator) that such program is not
substantially equivalent to such guidelines. In
making this determination, an existing State
program shall be presumed to be substantially
equivalent to the guidelines, notwithstanding
program differences, based on the size of systems or the quality of source water, providing
the State program meets the overall public
health objectives of the guidelines. If disapproved, the program may be resubmitted
within 6 months after receipt of notice of disapproval.
(d) Expense reimbursement
(1) In general
The Administrator shall provide reimbursement for the costs of training, including an
appropriate per diem for unsalaried operators,
and certification for persons operating systems serving 3,300 persons or fewer that are required to undergo training pursuant to this
section.
(2) State grants
The reimbursement shall be provided
through grants to States with each State receiving an amount sufficient to cover the reasonable costs for training all such operators in
the State, as determined by the Administrator, to the extent required by this section.
Grants received by a State pursuant to this
paragraph shall first be used to provide reimbursement for training and certification costs
of persons operating systems serving 3,300 persons or fewer. If a State has reimbursed all
such costs, the State may, after notice to the
Administrator, use any remaining funds from
the grant for any of the other purposes authorized for grants under section 300j–12 of this
title.
(3) Authorization
There are authorized to be appropriated to
the Administrator to provide grants for reimbursement under this section $30,000,000 for
each of fiscal years 1997 through 2003.
(4) Reservation
If the appropriation made pursuant to paragraph (3) for any fiscal year is not sufficient to
satisfy the requirements of paragraph (1), the
Administrator shall, prior to any other allocation or reservation, reserve such sums as necessary from the funds appropriated pursuant
to section 300j–12(m) of this title to provide reimbursement for the training and certification
costs mandated by this subsection.
(July 1, 1944, ch. 373, title XIV, § 1419, as added
Pub. L. 104–182, title I, § 123, Aug. 6, 1996, 110
Stat. 1652.)

§ 300g–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300g–9. Capacity development
(a) State authority for new systems
A State shall receive only 80 percent of the allotment that the State is otherwise entitled to
receive under section 300j–12 of this title (relating to State loan funds) unless the State has obtained the legal authority or other means to ensure that all new community water systems and
new nontransient, noncommunity water systems
commencing operation after October 1, 1999,
demonstrate technical, managerial, and financial capacity with respect to each national primary drinking water regulation in effect, or
likely to be in effect, on the date of commencement of operations.
(b) Systems in significant noncompliance
(1) List
Beginning not later than 1 year after August
6, 1996, each State shall prepare, periodically
update, and submit to the Administrator a list
of community water systems and nontransient, noncommunity water systems that have
a history of significant noncompliance with
this subchapter (as defined in guidelines issued
prior to August 6, 1996, or any revisions of the
guidelines that have been made in consultation with the States) and, to the extent practicable, the reasons for noncompliance.
(2) Report
Not later than 5 years after August 6, 1996,
and as part of the capacity development strategy of the State, each State shall report to the
Administrator on the success of enforcement
mechanisms and initial capacity development
efforts in assisting the public water systems
listed under paragraph (1) to improve technical, managerial, and financial capacity.
(3) Withholding
The list and report under this subsection
shall be considered part of the capacity development strategy of the State required under
subsection (c) of this section for purposes of
the withholding requirements of section
300j–12(a)(1)(G)(i) of this title (relating to
State loan funds).
(c) Capacity development strategy
(1) In general
Beginning 4 years after August 6, 1996, a
State shall receive only—
(A) 90 percent in fiscal year 2001;
(B) 85 percent in fiscal year 2002; and
(C) 80 percent in each subsequent fiscal
year,
of the allotment that the State is otherwise
entitled to receive under section 300j–12 of this
title (relating to State loan funds), unless the
State is developing and implementing a strategy to assist public water systems in acquiring
and maintaining technical, managerial, and financial capacity.
(2) Content
In preparing the capacity development strategy, the State shall consider, solicit public
comment on, and include as appropriate—
(A) the methods or criteria that the State
will use to identify and prioritize the public

Page 994

water systems most in need of improving
technical, managerial, and financial capacity;
(B) a description of the institutional, regulatory, financial, tax, or legal factors at the
Federal, State, or local level that encourage
or impair capacity development;
(C) a description of how the State will use
the authorities and resources of this subchapter or other means to—
(i) assist public water systems in complying with national primary drinking
water regulations;
(ii) encourage the development of partnerships between public water systems to
enhance the technical, managerial, and financial capacity of the systems; and
(iii) assist public water systems in the
training and certification of operators;
(D) a description of how the State will establish a baseline and measure improvements in capacity with respect to national
primary drinking water regulations and
State drinking water law; and
(E) an identification of the persons that
have an interest in and are involved in the
development and implementation of the capacity development strategy (including all
appropriate agencies of Federal, State, and
local governments, private and nonprofit
public water systems, and public water system customers).
(3) Report
Not later than 2 years after the date on
which a State first adopts a capacity development strategy under this subsection, and
every 3 years thereafter, the head of the State
agency that has primary responsibility to
carry out this subchapter in the State shall
submit to the Governor a report that shall
also be available to the public on the efficacy
of the strategy and progress made toward improving the technical, managerial, and financial capacity of public water systems in the
State.
(4) Review
The decisions of the State under this section
regarding any particular public water system
are not subject to review by the Administrator
and may not serve as the basis for withholding
funds under section 300j–12 of this title.
(d) Federal assistance
(1) In general
The Administrator shall support the States
in developing capacity development strategies.
(2) Informational assistance
(A) In general
Not later than 180 days after August 6,
1996, the Administrator shall—
(i) conduct a review of State capacity development efforts in existence on August 6,
1996, and publish information to assist
States and public water systems in capacity development efforts; and
(ii) initiate a partnership with States,
public water systems, and the public to de-

Page 995

TITLE 42—THE PUBLIC HEALTH AND WELFARE

velop information for States on recommended operator certification requirements.
(B) Publication of information
The Administrator shall publish the information developed through the partnership
under subparagraph (A)(ii) not later than 18
months after August 6, 1996.
(3) Promulgation of drinking water regulations
In promulgating a national primary drinking water regulation, the Administrator shall
include an analysis of the likely effect of compliance with the regulation on the technical,
financial, and managerial capacity of public
water systems.
(4) Guidance for new systems
Not later than 2 years after August 6, 1996,
the Administrator shall publish guidance developed in consultation with the States describing legal authorities and other means to
ensure that all new community water systems
and new nontransient, noncommunity water
systems demonstrate technical, managerial,
and financial capacity with respect to national primary drinking water regulations.
(e) Variances and exemptions
Based on information obtained under subsection (c)(3) of this section, the Administrator
shall, as appropriate, modify regulations concerning variances and exemptions for small public water systems to ensure flexibility in the use
of the variances and exemptions. Nothing in this
subsection shall be interpreted, construed, or
applied to affect or alter the requirements of
section 300g–4 or 300g–5 of this title.
(f) Small public water systems technology assistance centers
(1) Grant program
The Administrator is authorized to make
grants to institutions of higher learning to establish and operate small public water system
technology assistance centers in the United
States.
(2) Responsibilities of the centers
The responsibilities of the small public
water system technology assistance centers
established under this subsection shall include
the conduct of training and technical assistance relating to the information, performance,
and technical needs of small public water systems or public water systems that serve Indian Tribes.
(3) Applications
Any institution of higher learning interested
in receiving a grant under this subsection
shall submit to the Administrator an application in such form and containing such information as the Administrator may require by
regulation.
(4) Selection criteria
The Administrator shall select recipients of
grants under this subsection on the basis of
the following criteria:
(A) The small public water system technology assistance center shall be located in

§ 300g–9

a State that is representative of the needs of
the region in which the State is located for
addressing the drinking water needs of small
and rural communities or Indian Tribes.
(B) The grant recipient shall be located in
a region that has experienced problems, or
may reasonably be foreseen to experience
problems, with small and rural public water
systems.
(C) The grant recipient shall have access
to expertise in small public water system
technology management.
(D) The grant recipient shall have the capability to disseminate the results of small
public water system technology and training
programs.
(E) The projects that the grant recipient
proposes to carry out under the grant are
necessary and appropriate.
(F) The grant recipient has regional support beyond the host institution.
(5) Consortia of States
At least 2 of the grants under this subsection
shall be made to consortia of States with low
population densities.
(6) Authorization of appropriations
There are authorized to be appropriated to
make grants under this subsection $2,000,000
for each of the fiscal years 1997 through 1999,
and $5,000,000 for each of the fiscal years 2000
through 2003.
(g) Environmental finance centers
(1) In general
The Administrator shall provide initial
funding for one or more university-based environmental finance centers for activities that
provide technical assistance to State and local
officials in developing the capacity of public
water systems. Any such funds shall be used
only for activities that are directly related to
this subchapter.
(2) National capacity development clearinghouse
The Administrator shall establish a national
public water system capacity development
clearinghouse to receive and disseminate information with respect to developing, improving, and maintaining financial and managerial
capacity at public water systems. The Administrator shall ensure that the clearinghouse
does not duplicate other federally supported
clearinghouse activities.
(3) Capacity development techniques
The Administrator may request an environmental finance center funded under paragraph
(1) to develop and test managerial, financial,
and institutional techniques for capacity development. The techniques may include capacity assessment methodologies, manual and
computer based public water system rate models and capital planning models, public water
system consolidation procedures, and regionalization models.
(4) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection $1,500,000 for each of
the fiscal years 1997 through 2003.

§ 300h

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Limitation
No portion of any funds made available
under this subsection may be used for lobbying
expenses.
(July 1, 1944, ch. 373, title XIV, § 1420, as added
Pub. L. 104–182, title I, § 119, Aug. 6, 1996, 110
Stat. 1647.)
PART C—PROTECTION OF UNDERGROUND SOURCES
OF DRINKING WATER
§ 300h. Regulations for State programs
(a) Publication of proposed regulations; promulgation; amendments; public hearings; administrative consultations
(1) The Administrator shall publish proposed
regulations for State underground injection control programs within 180 days after December 16,
1974. Within 180 days after publication of such
proposed regulations, he shall promulgate such
regulations with such modifications as he deems
appropriate. Any regulation under this subsection may be amended from time to time.
(2) Any regulation under this section shall be
proposed and promulgated in accordance with
section 553 of title 5 (relating to rulemaking),
except that the Administrator shall provide opportunity for public hearing prior to promulgation of such regulations. In proposing and promulgating regulations under this section the
Administrator shall consult with the Secretary,
the National Drinking Water Advisory Council,
and other appropriate Federal entities and with
interested State entities.
(b) Minimum requirements; restrictions
(1) Regulations under subsection (a) of this
section for State underground injection programs shall contain minimum requirements for
effective programs to prevent underground injection which endangers drinking water sources
within the meaning of subsection (d)(2) of this
section. Such regulations shall require that a
State program, in order to be approved under
section 300h–1 of this title—
(A) shall prohibit, effective on the date on
which the applicable underground injection
control program takes effect, any underground
injection in such State which is not authorized
by a permit issued by the State (except that
the regulations may permit a State to authorize underground injection by rule);
(B) shall require (i) in the case of a program
which provides for authorization of underground injection by permit, that the applicant
for the permit to inject must satisfy the State
that the underground injection will not endanger drinking water sources, and (ii) in the case
of a program which provides for such an authorization by rule, that no rule may be promulgated which authorizes any underground
injection which endangers drinking water
sources;
(C) shall include inspection, monitoring, recordkeeping, and reporting requirements; and
(D) shall apply (i) as prescribed by section
300j–6(b) 1 of this title, to underground injections by Federal agencies, and (ii) to under1 See

References in Text note below.

Page 996

ground injections by any other person whether
or not occurring on property owned or leased
by the United States.
(2) Regulations of the Administrator under
this section for State underground injection
control programs may not prescribe requirements which interfere with or impede—
(A) the underground injection of brine or
other fluids which are brought to the surface
in connection with oil or natural gas production or natural gas storage operations, or
(B) any underground injection for the secondary or tertiary recovery of oil or natural
gas,
unless such requirements are essential to assure
that underground sources of drinking water will
not be endangered by such injection.
(3)(A) The regulations of the Administrator
under this section shall permit or provide for
consideration of varying geologic, hydrological,
or historical conditions in different States and
in different areas within a State.
(B)(i) In prescribing regulations under this
section the Administrator shall, to the extent
feasible, avoid promulgation of requirements
which would unnecessarily disrupt State underground injection control programs which are in
effect and being enforced in a substantial number of States.
(ii) For the purpose of this subparagraph, a
regulation prescribed by the Administrator
under this section shall be deemed to disrupt a
State underground injection control program
only if it would be infeasible to comply with
both such regulation and the State underground
injection control program.
(iii) For the purpose of this subparagraph, a
regulation prescribed by the Administrator
under this section shall be deemed unnecessary
only if, without such regulation, underground
sources of drinking water will not be endangered
by an underground injection.
(C) Nothing in this section shall be construed
to alter or affect the duty to assure that underground sources of drinking water will not be endangered by any underground injection.
(c) Temporary permits; notice and hearing
(1) The Administrator may, upon application
of the Governor of a State which authorizes underground injection by means of permits, authorize such State to issue (without regard to
subsection (b)(1)(B)(i) of this section) temporary
permits for underground injection which may be
effective until the, expiration of four years after
December 16, 1974, if—
(A) the Administrator finds that the State
has demonstrated that it is unable and could
not reasonably have been able to process all
permit applications within the time available;
(B) the Administrator determines the adverse effect on the environment of such temporary permits is not unwarranted;
(C) such temporary permits will be issued
only with respect to injection wells in operation on the date on which such State’s permit
program approved under this part first takes
effect and for which there was inadequate time
to process its permit application; and
(D) the Administrator determines the temporary permits require the use of adequate

Page 997

TITLE 42—THE PUBLIC HEALTH AND WELFARE

safeguards established by rules adopted by
him.
(2) The Administrator may, upon application
of the Governor of a State which authorizes underground injection by means of permits, authorize such State to issue (without regard to
subsection (b)(1)(B)(i) of this section), but after
reasonable notice and hearing, one or more temporary permits each of which is applicable to a
particular injection well and to the underground
injection of a particular fluid and which may be
effective until the expiration of four years after
December 16, 1974, if the State finds, on the
record of such hearing—
(A) that technology (or other means) to permit safe injection of the fluid in accordance
with the applicable underground injection control program is not generally available (taking
costs into consideration);
(B) that injection of the fluid would be less
harmful to health than the use of other available means of disposing of waste or producing
the desired product; and
(C) that available technology or other means
have been employed (and will be employed) to
reduce the volume and toxicity of the fluid
and to minimize the potentially adverse effect
of the injection on the public health.
(d)

‘‘Underground injection’’ defined; underground injection endangerment of drinking
water sources
For purposes of this part:
(1) UNDERGROUND INJECTION.—The term ‘‘underground injection’’—
(A) means the subsurface emplacement of
fluids by well injection; and
(B) excludes—
(i) the underground injection of natural
gas for purposes of storage; and
(ii) the underground injection of fluids or
propping agents (other than diesel fuels)
pursuant to hydraulic fracturing operations related to oil, gas, or geothermal
production activities.
(2) Underground injection endangers drinking water sources if such injection may result
in the presence in underground water which
supplies or can reasonably be expected to supply any public water system of any contaminant, and if the presence of such contaminant
may result in such system’s not complying
with any national primary drinking water regulation or may otherwise adversely affect the
health of persons.

(July 1, 1944, ch. 373, title XIV, § 1421, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1674;
amended Pub. L. 95–190, § 6(b), Nov. 16, 1977, 91
Stat. 1396; Pub. L. 96–502, §§ 3, 4(c), Dec. 5, 1980, 94
Stat. 2738; Pub. L. 99–339, title II, § 201(a), June
19, 1986, 100 Stat. 653; Pub. L. 104–182, title V,
§ 501(b)(1), Aug. 6, 1996, 110 Stat. 1691; Pub. L.
109–58, title III, § 322, Aug. 8, 2005, 119 Stat. 694.)
REFERENCES IN TEXT
Section 300j–6(b) of this title, referred to in subsec.
(b)(1)(D), was repealed, and a new section 300j–6(b) relating to administrative penalty orders was added, by
Pub. L. 104–182, title I, § 129(a), Aug. 6, 1996, 110 Stat.
1660.

§ 300h–1

AMENDMENTS
2005—Subsec. (d)(1). Pub. L. 109–58 inserted heading
and amended text of par. (1) generally. Prior to amendment, par. (1) read as follows: ‘‘The term ‘underground
injection’ means the subsurface emplacement of fluids
by well injection. Such term does not include the underground injection of natural gas for purposes of storage.’’
1996—Subsec. (b)(3)(B)(i). Pub. L. 104–182 substituted
‘‘number of States’’ for ‘‘number or States’’.
1986—Subsec. (b)(2)(A). Pub. L. 99–339 inserted ‘‘or
natural gas storage operations’’ after ‘‘production’’.
1980—Subsec. (b)(1)(A). Pub. L. 96–502, § 4(c), substituted ‘‘effective on the date on which the applicable
underground injection control program takes effect’’
for ‘‘effective three years after December 16, 1974’’.
Subsec. (d)(1). Pub. L. 96–502, § 3, inserted provision
that such term does not include the underground injection of natural gas for purposes of storage.
1977—Subsec. (b)(3). Pub. L. 95–190 added par. (3).

§ 300h–1. State primary enforcement responsibility
(a) List of States in need of a control program;
amendment of list
Within 180 days after December 16, 1974, the
Administrator shall list in the Federal Register
each State for which in his judgment a State underground injection control program may be
necessary to assure that underground injection
will not endanger drinking water sources. Such
list may be amended from time to time.
(b) State applications; notice to Administrator of
compliance with revised or added requirements; approval or disapproval by Administrator; duration of State primary enforcement responsibility; public hearing
(1)(A) Each State listed under subsection (a) of
this section shall within 270 days after the date
of promulgation of any regulation under section
300h of this title (or, if later, within 270 days
after such State is first listed under subsection
(a) of this section) submit to the Administrator
an application which contains a showing satisfactory to the Administrator that the State—
(i) has adopted after reasonable notice and
public hearings, and will implement, an underground injection control program which meets
the requirements of regulations in effect under
section 300h of this title; and
(ii) will keep such records and make such reports with respect to its activities under its
underground injection control program as the
Administrator may require by regulation.
The Administrator may, for good cause, extend
the date for submission of an application by any
State under this subparagraph for a period not
to exceed an additional 270 days.
(B) Within 270 days of any amendment of a
regulation under section 300h of this title revising or adding any requirement respecting State
underground injection control programs, each
State listed under subsection (a) of this section
shall submit (in such form and manner as the
Administrator may require) a notice to the Administrator containing a showing satisfactory
to him that the State underground injection
control program meets the revised or added requirement.
(2) Within ninety days after the State’s application under paragraph (1)(A) or notice under

§ 300h–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

paragraph (1)(B) and after reasonable opportunity for presentation of views, the Administrator shall by rule either approve, disapprove,
or approve in part and disapprove in part, the
State’s underground injection control program.
(3) If the Administrator approves the State’s
program under paragraph (2), the State shall
have primary enforcement responsibility for underground water sources until such time as the
Administrator determines, by rule, that such
State no longer meets the requirements of
clause (i) or (ii) of paragraph (1)(A) of this subsection.
(4) Before promulgating any rule under paragraph (2) or (3) of this subsection, the Administrator shall provide opportunity for public hearing respecting such rule.
(c) Program by Administrator for State without
primary enforcement responsibility; restrictions
If the Administrator disapproves a State’s program (or part thereof) under subsection (b)(2) of
this section, if the Administrator determines
under subsection (b)(3) of this section that a
State no longer meets the requirements of
clause (i) or (ii) of subsection (b)(1)(A) of this
section, or if a State fails to submit an application or notice before the date of expiration of
the period specified in subsection (b)(1) of this
section, the Administrator shall by regulation
within 90 days after the date of such disapproval, determination, or expiration (as the
case may be) prescribe (and may from time to
time by regulation revise) a program applicable
to such State meeting the requirements of section 300h(b) of this title. Such program may not
include requirements which interfere with or
impede—
(1) the underground injection of brine or
other fluids which are brought to the surface
in connection with oil or natural gas production or natural gas storage operations, or
(2) any underground injection for the secondary or tertiary recovery of oil or natural gas,
unless such requirements are essential to assure
that underground sources of drinking water will
not be endangered by such injection. Such program shall apply in such State to the extent
that a program adopted by such State which the
Administrator determines meets such requirements is not in effect. Before promulgating any
regulation under this section, the Administrator
shall provide opportunity for public hearing respecting such regulation.
(d) ‘‘Applicable underground injection control
program’’ defined
For purposes of this subchapter, the term ‘‘applicable underground injection control program’’ with respect to a State means the program (or most recent amendment thereof) (1)
which has been adopted by the State and which
has been approved under subsection (b) of this
section, or (2) which has been prescribed by the
Administrator under subsection (c) of this section.
(e) Primary enforcement responsibility by Indian
Tribe
An Indian Tribe may assume primary enforcement responsibility for underground injection

Page 998

control under this section consistent with such
regulations as the Administrator has prescribed
pursuant to this part and section 300j–11 of this
title. The area over which such Indian Tribe exercises governmental jurisdiction need not have
been listed under subsection (a) of this section,
and such Tribe need not submit an application
to assume primary enforcement responsibility
within the 270-day deadline noted in subsection
(b)(1)(A) of this section. Until an Indian Tribe
assumes primary enforcement responsibility,
the currently applicable underground injection
control program shall continue to apply. If an
applicable underground injection control program does not exist for an Indian Tribe, the Administrator shall prescribe such a program pursuant to subsection (c) of this section, and consistent with section 300h(b) of this title, within
270 days after June 19, 1986, unless an Indian
Tribe first obtains approval to assume primary
enforcement responsibility for underground injection control.
(July 1, 1944, ch. 373, title XIV, § 1422, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1676;
amended Pub. L. 95–190, § 6(a), Nov. 16, 1977, 91
Stat. 1396; Pub. L. 99–339, title II, § 201(a), title
III, § 302(c), June 19, 1986, 100 Stat. 653, 666.)
AMENDMENTS
1986—Subsec. (c)(1). Pub. L. 99–339, § 201(a), inserted
‘‘or natural gas storage operations, or’’ after ‘‘production’’.
Subsec. (e). Pub. L. 99–339, § 302(c), added subsec. (e).
1977—Subsec. (b)(1)(A). Pub. L. 95–190 inserted provisions relating to extension of date for submission of applications by any State.

§ 300h–2. Enforcement of program
(a) Notice to State and violator; issuance of administrative order; civil action
(1) Whenever the Administrator finds during a
period during which a State has primary enforcement responsibility for underground water
sources (within the meaning of section
300h–1(b)(3) of this title or section 300h–4(c) of
this title) that any person who is subject to a requirement of an applicable underground injection control program in such State is violating
such requirement, he shall so notify the State
and the person violating such requirement. If
beyond the thirtieth day after the Administrator’s notification the State has not commenced
appropriate enforcement action, the Administrator shall issue an order under subsection (c)
of this section requiring the person to comply
with such requirement or the Administrator
shall commence a civil action under subsection
(b) of this section.
(2) Whenever the Administrator finds during a
period during which a State does not have primary enforcement responsibility for underground water sources that any person subject to
any requirement of any applicable underground
injection control program in such State is violating such requirement, the Administrator
shall issue an order under subsection (c) of this
section requiring the person to comply with
such requirement or the Administrator shall
commence a civil action under subsection (b) of
this section.

Page 999

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Civil and criminal actions
Civil actions referred to in paragraphs (1) and
(2) of subsection (a) of this section shall be
brought in the appropriate United States district court. Such court shall have jurisdiction to
require compliance with any requirement of an
applicable underground injection program or
with an order issued under subsection (c) of this
section. The court may enter such judgment as
protection of public health may require. Any
person who violates any requirement of an applicable underground injection control program
or an order requiring compliance under subsection (c) of this section—
(1) shall be subject to a civil penalty of not
more than $25,000 for each day of such violation, and
(2) if such violation is willful, such person
may, in addition to or in lieu of the civil penalty authorized by paragraph (1), be imprisoned for not more than 3 years, or fined in accordance with title 18, or both.
(c) Administrative orders
(1) In any case in which the Administrator is
authorized to bring a civil action under this section with respect to any regulation or other requirement of this part other than those relating
to—
(A) the underground injection of brine or
other fluids which are brought to the surface
in connection with oil or natural gas production, or
(B) any underground injection for the secondary or tertiary recovery of oil or natural
gas,
the Administrator may also issue an order under
this subsection either assessing a civil penalty
of not more than $10,000 for each day of violation
for any past or current violation, up to a maximum administrative penalty of $125,000, or requiring compliance with such regulation or
other requirement, or both.
(2) In any case in which the Administrator is
authorized to bring a civil action under this section with respect to any regulation, or other requirement of this part relating to—
(A) the underground injection of brine or
other fluids which are brought to the surface
in connection with oil or natural gas production, or
(B) any underground injection for the secondary or tertiary recovery of oil or natural
gas,
the Administrator may also issue an order under
this subsection either assessing a civil penalty
of not more than $5,000 for each day of violation
for any past or current violation, up to a maximum administrative penalty of $125,000, or requiring compliance with such regulation or
other requirement, or both.
(3)(A) An order under this subsection shall be
issued by the Administrator after opportunity
(provided in accordance with this subparagraph)
for a hearing. Before issuing the order, the Administrator shall give to the person to whom it
is directed written notice of the Administrator’s
proposal to issue such order and the opportunity
to request, within 30 days of the date the notice
is received by such person, a hearing on the

§ 300h–2

order. Such hearing shall not be subject to section 554 or 556 of title 5, but shall provide a reasonable opportunity to be heard and to present
evidence.
(B) The Administrator shall provide public notice of, and reasonable opportunity to comment
on, any proposed order.
(C) Any citizen who comments on any proposed order under subparagraph (B) shall be
given notice of any hearing under this subsection and of any order. In any hearing held
under subparagraph (A), such citizen shall have
a reasonable opportunity to be heard and to
present evidence.
(D) Any order issued under this subsection
shall become effective 30 days following its issuance unless an appeal is taken pursuant to paragraph (6).
(4)(A) Any order issued under this subsection
shall state with reasonable specificity the nature of the violation and may specify a reasonable time for compliance.
(B) In assessing any civil penalty under this
subsection, the Administrator shall take into
account appropriate factors, including (i) the seriousness of the violation; (ii) the economic benefit (if any) resulting from the violation; (iii)
any history of such violations; (iv) any goodfaith efforts to comply with the applicable requirements; (v) the economic impact of the penalty on the violator; and (vi) such other matters
as justice may require.
(5) Any violation with respect to which the
Administrator has commenced and is diligently
prosecuting an action, or has issued an order
under this subsection assessing a penalty, shall
not be subject to an action under subsection (b)
of this section or section 300h–3(c) or 300j–8 of
this title, except that the foregoing limitation
on civil actions under section 300j–8 of this title
shall not apply with respect to any violation for
which—
(A) a civil action under section 300j–8(a)(1) of
this title has been filed prior to commencement of an action under this subsection, or
(B) a notice of violation under section
300j–8(b)(1) of this title has been given before
commencement of an action under this subsection and an action under section 300j–8(a)(1)
of this title is filed before 120 days after such
notice is given.
(6) Any person against whom an order is issued
or who commented on a proposed order pursuant
to paragraph (3) may file an appeal of such order
with the United States District Court for the
District of Columbia or the district in which the
violation is alleged to have occurred. Such an
appeal may only be filed within the 30-day period beginning on the date the order is issued.
Appellant shall simultaneously send a copy of
the appeal by certified mail to the Administrator and to the Attorney General. The Administrator shall promptly file in such court a certified copy of the record on which such order
was imposed. The district court shall not set
aside or remand such order unless there is not
substantial evidence on the record, taken as a
whole, to support the finding of a violation or,
unless the Administrator’s assessment of penalty or requirement for compliance constitutes
an abuse of discretion. The district court shall

§ 300h–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

not impose additional civil penalties for the
same violation unless the Administrator’s assessment of a penalty constitutes an abuse of
discretion. Notwithstanding section 300j–7(a)(2)
of this title, any order issued under paragraph
(3) shall be subject to judicial review exclusively
under this paragraph.
(7) If any person fails to pay an assessment of
a civil penalty—
(A) after the order becomes effective under
paragraph (3), or
(B) after a court, in an action brought under
paragraph (6), has entered a final judgment in
favor of the Administrator,
the Administrator may request the Attorney
General to bring a civil action in an appropriate
district court to recover the amount assessed
(plus costs, attorneys’ fees, and interest at currently prevailing rates from the date the order
is effective or the date of such final judgment,
as the case may be). In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.
(8) The Administrator may, in connection with
administrative proceedings under this subsection, issue subpoenas compelling the attendance and testimony of witnesses and subpoenas
duces tecum, and may request the Attorney
General to bring an action to enforce any subpoena under this section. The district courts
shall have jurisdiction to enforce such subpoenas and impose sanction.
(d) State authority to adopt or enforce laws or
regulations respecting underground injection unaffected
Nothing in this subchapter shall diminish any
authority of a State or political subdivision to
adopt or enforce any law or regulation respecting underground injection but no such law or
regulation shall relieve any person of any requirement otherwise applicable under this subchapter.
(July 1, 1944, ch. 373, title XIV, § 1423, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1677;
amended Pub. L. 96–502, § 2(b), Dec. 5, 1980, 94
Stat. 2738; Pub. L. 99–339, title II, § 202, June 19,
1986, 100 Stat. 654.)
AMENDMENTS
1986—Pub. L. 99–339, § 202(d), substituted ‘‘Enforcement’’ for ‘‘Failure of State to assure enforcement’’ in
section catchline.
Subsec. (a)(1). Pub. L. 99–339, § 202(a)(1), substituted
provisions which related to issuance of an order of compliance or commencement of a civil action by the Administrator if the State has not commenced enforcement against the violator for provisions directing the
Administrator to give public notice and request that
the State report within 15 days thereafter as to steps
taken to enforce compliance and authorizing the Administrator to commence a civil action upon failure by
the State to comply timely.
Subsec. (a)(2). Pub. L. 99–339, § 202(a)(2), substituted
provision that the Administrator issue an order under
subsec. (c) of this section or commence a civil action
under subsec. (b) of this section for provision that he
commence a civil action under subsec. (b)(1) of this section.
Subsec. (b). Pub. L. 99–339, § 202(b), amended subsec.
(b) generally, substituting provisions relating to jurisdiction of the appropriate Federal district court, entry
of judgment, civil penalty of $25,000 per day, criminal

Page 1000

liability and fine for willful violation for provisions
which related to judicial determinations in appropriate
Federal district courts, civil penalties of $5,000 per day,
and fines of $10,000 per day for willful violations.
Subsecs. (c), (d). Pub. L. 99–339, § 202(c), added subsec.
(c) and redesignated former subsec. (c) as (d).
1980—Subsec. (a)(1). Pub. L. 96–502 inserted reference
to section 300h–4(c) of this title.

§ 300h–3. Interim regulation of underground injections
(a) Necessity for well operation permit; designation of one aquifer areas
(1) Any person may petition the Administrator
to have an area of a State (or States) designated
as an area in which no new underground injection well may be operated during the period beginning on the date of the designation and ending on the date on which the applicable underground injection control program covering such
area takes effect unless a permit for the operation of such well has been issued by the Administrator under subsection (b) of this section. The
Administrator may so designate an area within
a State if he finds that the area has one aquifer
which is the sole or principal drinking water
source for the area and which, if contaminated,
would create a significant hazard to public
health.
(2) Upon receipt of a petition under paragraph
(1) of this subsection, the Administrator shall
publish it in the Federal Register and shall provide an opportunity to interested persons to submit written data, views, or arguments thereon.
Not later than the 30th day following the date of
the publication of a petition under this paragraph in the Federal Register, the Administrator shall either make the designation for
which the petition is submitted or deny the petition.
(b) Well operation permits; publication in Federal Register; notice and hearing; issuance or
denial; conditions for issuance
(1) During the period beginning on the date an
area is designated under subsection (a) of this
section and ending on the date the applicable
underground injection control program covering
such area takes effect, no new underground injection well may be operated in such area unless
the Administrator has issued a permit for such
operation.
(2) Any person may petition the Administrator
for the issuance of a permit for the operation of
such a well in such an area. A petition submitted under this paragraph shall be submitted in
such manner and contain such information as
the Administrator may require by regulation.
Upon receipt of such a petition, the Administrator shall publish it in the Federal Register.
The Administrator shall give notice of any proceeding on a petition and shall provide opportunity for agency hearing. The Administrator
shall act upon such petition on the record of any
hearing held pursuant to the preceding sentence
respecting such petition. Within 120 days of the
publication in the Federal Register of a petition
submitted under this paragraph, the Administrator shall either issue the permit for which
the petition was submitted or shall deny its issuance.
(3) The Administrator may issue a permit for
the operation of a new underground injection

Page 1001

TITLE 42—THE PUBLIC HEALTH AND WELFARE

well in an area designated under subsection (a)
of this section only, if he finds that the operation of such well will not cause contamination
of the aquifer of such area so as to create a significant hazard to public health. The Administrator may condition the issuance of such a permit upon the use of such control measures in
connection with the operation of such well, for
which the permit is to be issued, as he deems
necessary to assure that the operation of the
well will not contaminate the aquifer of the designated area in which the well is located so as to
create a significant hazard to public health.
(c) Civil penalties; separate violations; penalties
for willful violations; temporary restraining
order or injunction
Any person who operates a new underground
injection well in violation of subsection (b) of
this section, (1) shall be subject to a civil penalty of not more than $5,000 for each day in
which such violation occurs, or (2) if such violation is willful, such person may, in lieu of the
civil penalty authorized by clause (1), be fined
not more than $10,000 for each day in which such
violation occurs. If the Administrator has reason to believe that any person is violating or
will violate subsection (b) of this section, he
may petition the United States district court to
issue a temporary restraining order or injunction (including a mandatory injunction) to enforce such subsection.
(d) ‘‘New underground injection well’’ defined
For purposes of this section, the term ‘‘new
underground injection well’’ means an underground injection well whose operation was not
approved by appropriate State and Federal agencies before December 16, 1974.
(e) Areas with one aquifer; publication in Federal Register; commitments for Federal financial assistance
If the Administrator determines, on his own
initiative or upon petition, that an area has an
aquifer which is the sole or principal drinking
water source for the area and which, if contaminated, would create a significant hazard to public health, he shall publish notice of that determination in the Federal Register. After the publication of any such notice, no commitment for
Federal financial assistance (through a grant,
contract, loan guarantee, or otherwise) may be
entered into for any project which the Administrator determines may contaminate such aquifer through a recharge zone so as to create a significant hazard to public health, but a commitment for Federal financial assistance may, if authorized under another provision of law, be entered into to plan or design the project to assure
that it will not so contaminate the aquifer.
(July 1, 1944, ch. 373, title XIV, § 1424, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1678.)
§ 300h–4. Optional demonstration by States relating to oil or natural gas
(a) Approval of State underground injection control program; alternative showing of effectiveness of program by State
For purposes of the Administrator’s approval
or disapproval under section 300h–1 of this title

§ 300h–4

of that portion of any State underground injection control program which relates to—
(1) the underground injection of brine or
other fluids which are brought to the surface
in connection with oil or natural gas production or natural gas storage operations, or
(2) any underground injection for the secondary or tertiary recovery of oil or natural gas,
in lieu of the showing required under subparagraph (A) of section 300h–1(b)(1) of this title the
State may demonstrate that such portion of the
State program meets the requirements of subparagraphs (A) through (D) of section 300h(b)(1)
of this title and represents an effective program
(including adequate recordkeeping and reporting) to prevent underground injection which endangers drinking water sources.
(b) Revision or amendment of requirements of
regulation; showing of effectiveness of program by State
If the Administrator revises or amends any requirement of a regulation under section 300h of
this title relating to any aspect of the underground injection referred to in subsection (a) of
this section, in the case of that portion of a
State underground injection control program for
which the demonstration referred to in subsection (a) of this section has been made, in lieu
of
the
showing
required
under
section
300h–1(b)(1)(B) of this title the State may demonstrate that, with respect to that aspect of
such underground injection, the State program
meets the requirements of subparagraphs (A)
through (D) of section 300h(b)(1) of this title and
represents an effective program (including adequate recordkeeping and reporting) to prevent
underground injection which endangers drinking
water sources.
(c) Primary enforcement responsibility of State;
voiding by Administrator under duly promulgated rule
(1) Section 300h–1(b)(3) of this title shall not
apply to that portion of any State underground
injection control program approved by the Administrator pursuant to a demonstration under
subsection (a) of this section (and under subsection (b) of this section where applicable).
(2) If pursuant to such a demonstration, the
Administrator approves such portion of the
State program, the State shall have primary enforcement responsibility with respect to that
portion until such time as the Administrator determines, by rule, that such demonstration is no
longer valid. Following such a determination,
the Administrator may exercise the authority of
subsection (c) of section 300h–1 of this title in
the same manner as provided in such subsection
with respect to a determination described in
such subsection.
(3) Before promulgating any rule under paragraph (2), the Administrator shall provide opportunity for public hearing respecting such rule.
(July 1, 1944, ch. 373, title XIV, § 1425, as added
Pub. L. 96–502, § 2(a), Dec. 5, 1980, 94 Stat. 2737;
amended Pub. L. 99–339, title II, § 201(a), June 19,
1986, 100 Stat. 653.)
AMENDMENTS
1986—Subsec. (a)(1). Pub. L. 99–339 inserted ‘‘or natural gas storage operations, or’’ after ‘‘production’’.

§ 300h–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300h–5. Regulation of State programs
Not later than 18 months after June 19, 1986,
the Administrator shall modify regulations issued under this chapter for Class I injection
wells to identify monitoring methods, in addition to those in effect on November 1, 1985, including groundwater monitoring. In accordance
with such regulations, the Administrator, or
delegated State authority, shall determine the
applicability of such monitoring methods, wherever appropriate, at locations and in such a
manner as to provide the earliest possible detection of fluid migration into, or in the direction
of, underground sources of drinking water from
such wells, based on its assessment of the potential for fluid migration from the injection zone
that may be harmful to human health or the environment. For purposes of this subsection, a
class I injection well is defined in accordance
with 40 CFR 146.05 as in effect on November 1,
1985.
(July 1, 1944, ch. 373, title XIV, § 1426, as added
Pub. L. 99–339, title II, § 201(b), June 19, 1986, 100
Stat. 653; amended Pub. L. 104–66, title II,
§ 2021(f), Dec. 21, 1995, 109 Stat. 727; Pub. L.
104–182, title V, § 501(f)(2), Aug. 6, 1996, 110 Stat.
1691.)
AMENDMENTS
1996—Pub. L. 104–182 directed technical amendment of
section catchline and subsec. (a) designation. The provision directing amendment of subsec. (a) designation
could not be executed because section does not contain
a subsec. (a).
1995—Pub. L. 104–66 struck out subsec. (a) designation
and heading before ‘‘Not later than’’ and struck out
heading and text of subsec. (b). Text read as follows:
‘‘The Administrator shall submit a report to Congress,
no later than September 1987, summarizing the results
of State surveys required by the Administrator under
this section. The report shall include each of the following items of information:
‘‘(1) The numbers and categories of class V wells
which discharge nonhazardous waste into or above an
underground source of drinking water.
‘‘(2) The primary contamination problems associated with different categories of these disposal wells.
‘‘(3) Recommendations for minimum design, construction, installation, and siting requirements that
should be applied to protect underground sources of
drinking water from such contamination wherever
necessary.’’

§ 300h–6. Sole source aquifer demonstration program
(a) Purpose
The purpose of this section is to establish procedures for development, implementation, and
assessment of demonstration programs designed
to protect critical aquifer protection areas located within areas designated as sole or principal source aquifers under section 300h–3(e) of
this title.
(b) ‘‘Critical aquifer protection area’’ defined
For purposes of this section, the term ‘‘critical aquifer protection area’’ means either of the
following:
(1) All or part of an area located within an
area for which an application or designation
as a sole or principal source aquifer pursuant
to section 300h–3(e) of this title, has been sub-

Page 1002

mitted and approved by the Administrator and
which satisfies the criteria established by the
Administrator under subsection (d) of this section.
(2) All or part of an area which is within an
aquifer designated as a sole source aquifer as
of June 19, 1986, and for which an areawide
ground water quality protection plan has been
approved under section 208 of the Clean Water
Act [33 U.S.C. 1288] prior to June 19, 1986.
(c) Application
Any State, municipal or local government or
political subdivision thereof or any planning entity (including any interstate regional planning
entity) that identifies a critical aquifer protection area over which it has authority or jurisdiction may apply to the Administrator for the selection of such area for a demonstration program under this section. Any applicant shall
consult with other government or planning entities with authority or jurisdiction in such area
prior to application. Applicants, other than the
Governor, shall submit the application for a
demonstration program jointly with the Governor.
(d) Criteria
Not later than 1 year after June 19, 1986, the
Administrator shall, by rule, establish criteria
for identifying critical aquifer protection areas
under this section. In establishing such criteria,
the Administrator shall consider each of the following:
(1) The vulnerability of the aquifer to contamination due to hydrogeologic characteristics.
(2) The number of persons or the proportion
of population using the ground water as a
drinking water source.
(3) The economic, social and environmental
benefits that would result to the area from
maintenance of ground water of high quality.
(4) The economic, social and environmental
costs that would result from degradation of
the quality of the ground water.
(e) Contents of application
An application submitted to the Administrator by any applicant for a demonstration program under this section shall meet each of the
following requirements:
(1) The application shall propose boundaries
for the critical aquifer protection area within
its jurisdiction.
(2) The application shall designate or, if necessary, establish a planning entity (which
shall be a public agency and which shall include representation of elected local and State
governmental officials) to develop a comprehensive management plan (hereinafter in this
section referred to as the ‘‘plan’’) for the critical protection area. Where a local government
planning agency exists with adequate authority to carry out this section with respect to
any proposed critical protection area, such
agency shall be designated as the planning entity.
(3) The application shall establish procedures for public participation in the development of the plan, for review, approval, and
adoption of the plan, and for assistance to mu-

Page 1003

TITLE 42—THE PUBLIC HEALTH AND WELFARE

nicipalities and other public agencies with authority under State law to implement the
plan.
(4) The application shall include a hydrogeologic assessment of surface and ground
water resources within the critical protection
area.
(5) The application shall include a comprehensive management plan for the proposed
protection area.
(6) The application shall include the measures and schedule proposed for implementation of such plan.
(f) Comprehensive plan
(1) The objective of a comprehensive management plan submitted by an applicant under this
section shall be to maintain the quality of the
ground water in the critical protection area in a
manner reasonably expected to protect human
health, the environment and ground water resources. In order to achieve such objective, the
plan may be designed to maintain, to the maximum extent possible, the natural vegetative and
hydrogeological conditions. Each of the following elements shall be included in such a protection plan:
(A) A map showing the detailed boundary of
the critical protection area.
(B) An identification of existing and potential point and nonpoint sources of ground
water degradation.
(C) An assessment of the relationship between activities on the land surface and
ground water quality.
(D) Specific actions and management practices to be implemented in the critical protection area to prevent adverse impacts on
ground water quality.
(E) Identification of authority adequate to
implement the plan, estimates of program
costs, and sources of State matching funds.
(2) Such plan may also include the following:
(A) A determination of the quality of the existing ground water recharged through the
special protection area and the natural recharge capabilities of the special protection
area watershed.
(B) Requirements designed to maintain existing underground drinking water quality or
improve underground drinking water quality
if prevailing conditions fail to meet drinking
water standards, pursuant to this chapter and
State law.
(C) Limits on Federal, State, and local government, financially assisted activities and
projects which may contribute to degradation
of such ground water or any loss of natural
surface and subsurface infiltration of purification capability of the special protection watershed.
(D) A comprehensive statement of land use
management including emergency contingency planning as it pertains to the maintenance of the quality of underground sources of
drinking water or to the improvement of such
sources if necessary to meet drinking water
standards pursuant to this chapter and State
law.
(E) Actions in the special protection area
which would avoid adverse impacts on water
quality, recharge capabilities, or both.

§ 300h–6

(F) Consideration of specific techniques,
which may include clustering, transfer of development rights, and other innovative measures sufficient to achieve the objectives of this
section.
(G) Consideration of the establishment of a
State institution to facilitate and assist funding a development transfer credit system.
(H) A program for State and local implementation of the plan described in this subsection
in a manner that will insure the continued,
uniform, consistent protection of the critical
protection area in accord with the purposes of
this section.
(I) Pollution abatement measures, if appropriate.
(g) Plans under section 208 of Clean Water Act
A plan approved before June 19, 1986, under
section 208 of the Clean Water Act [33 U.S.C.
1288] to protect a sole source aquifer designated
under section 300h–3(e) of this title shall be considered a comprehensive management plan for
the purposes of this section.
(h) Consultation and hearings
During the development of a comprehensive
management plan under this section, the planning entity shall consult with, and consider the
comments of, appropriate officials of any municipality and State or Federal agency which
has jurisdiction over lands and waters within
the special protection area, other concerned organizations and technical and citizen advisory
committees. The planning entity shall conduct
public hearings at places within the special protection area for the purpose of providing the opportunity to comment on any aspect of the plan.
(i) Approval or disapproval
Within 120 days after receipt of an application
under this section, the Administrator shall approve or disapprove the application. The approval or disapproval shall be based on a determination that the critical protection area satisfies the criteria established under subsection (d)
of this section and that a demonstration program for the area would provide protection for
ground water quality consistent with the objectives stated in subsection (f) of this section. The
Administrator shall provide to the Governor a
written explanation of the reasons for the disapproval of any such application. Any petitioner
may modify and resubmit any application which
is not approved. Upon approval of an application, the Administrator may enter into a cooperative agreement with the applicant to establish a demonstration program under this section.
(j) Grants and reimbursement
Upon entering a cooperative agreement under
subsection (i) of this section, the Administrator
may provide to the applicant, on a matching
basis, a grant of 50 per centum of the costs of
implementing the plan established under this
section. The Administrator may also reimburse
the applicant of an approved plan up to 50 per
centum of the costs of developing such plan, except for plans approved under section 208 of the
Clean Water Act [33 U.S.C. 1288]. The total
amount of grants under this section for any one

§ 300h–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

aquifer, designated under section 300h–3(e) of
this title, shall not exceed $4,000,000 in any one
fiscal year.
(k) Activities funded under other law
No funds authorized under this section may be
used to fund activities funded under other sections of this chapter or the Clean Water Act [33
U.S.C. 1251 et seq.], the Solid Waste Disposal Act
[42 U.S.C. 6901 et seq.], the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 [42 U.S.C. 9601 et seq.] or other environmental laws.
(l) Savings provision
Nothing under this section shall be construed
to amend, supersede or abrogate rights to quantities of water which have been established by
interstate water compacts, Supreme Court decrees, or State water laws; or any requirement
imposed or right provided under any Federal or
State environmental or public health statute.
(m) Authorization of appropriations
There are authorized to be appropriated to
carry out this section not more than the following amounts:
Fiscal year:
1987 ......................................................
1988 ......................................................
1989 ......................................................
1990 ......................................................
1991 ......................................................
1992–2003 ..............................................

Amount
$10,000,000
15,000,000
17,500,000
17,500,000
17,500,000
15,000,000.

Matching grants under this section may also be
used to implement or update any water quality
management plan for a sole or principal source
aquifer approved (before June 19, 1986) by the
Administrator under section 208 of the Federal
Water Pollution Control Act [33 U.S.C. 1288].
(July 1, 1944, ch. 373, title XIV, § 1427, as added
and amended Pub. L. 99–339, title II, § 203, title
III, § 301(f), June 19, 1986, 100 Stat. 657, 664; Pub.
L. 104–66, title II, § 2021(g), Dec. 21, 1995, 109 Stat.
727; Pub. L. 104–182, title I, § 120(a), title V,
§ 501(b)(2), (f)(3), Aug. 6, 1996, 110 Stat. 1650, 1691.)
REFERENCES IN TEXT
The Clean Water Act, referred to in subsec. (k), is act
June 30, 1948, ch. 758, as amended generally by Pub. L.
92–500, § 2, Oct. 18, 1972, 86 Stat. 816, also known as the
Federal Water Pollution Control Act, which is classified generally to chapter 26 (§ 1251 et seq.) of Title 33,
Navigation and Navigable Waters. For complete classification of this Act to the Code, see Short Title note
set out under section 1251 of Title 33 and Tables.
The Solid Waste Disposal Act, referred to in subsec.
(k), is title II of Pub. L. 89–272, Oct. 20, 1965, 79 Stat. 997,
as amended generally by Pub. L. 94–580, § 2, Oct. 21, 1976,
90 Stat. 2795, which is classified generally to chapter 82
(§ 6901 et seq.) of this title. For complete classification
of this Act to the Code, see Short Title note set out
under section 6901 of this title and Tables.
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980, referred to in subsec. (k), is Pub. L. 96–510, Dec. 11, 1980, 94 Stat. 2767, as
amended, which is classified principally to chapter 103
(§ 9601 et seq.) of this title. For complete classification
of this Act to the Code, see Short Title note set out
under section 9601 of this title and Tables.
AMENDMENTS
1996—Pub. L. 104–182, § 501(f)(3), made technical
amendment to section catchline and subsec. (a) designation.

Page 1004

Subsec. (b)(1). Pub. L. 104–182, § 120(a)(1), struck out
‘‘not later than 24 months after June 19, 1986,’’ after
‘‘by the Administrator’’.
Subsec. (k). Pub. L. 104–182, § 501(b)(2), substituted
‘‘this section’’ for ‘‘this subsection’’.
Subsec. (m). Pub. L. 104–182, § 120(a)(2), inserted table
item relating to fiscal years 1992 through 2003.
1995—Subsecs. (l) to (n). Pub. L. 104–66 redesignated
subsecs. (m) and (n) as (l) and (m), respectively, and
struck out heading and text of former subsec. (l). Text
read as follows: ‘‘Not later than December 31, 1989, each
State shall submit to the Administrator a report assessing the impact of the program on ground water
quality and identifying those measures found to be effective in protecting ground water resources. No later
than September 30, 1990, the Administrator shall submit to Congress a report summarizing the State reports, and assessing the accomplishments of the sole
source aquifer demonstration program including an
identification of protection methods found to be most
effective and recommendations for their application to
protect ground water resources from contamination
whenever necessary.’’
1986—Subsec. (n). Pub. L. 99–339 added subsec. (n).

§ 300h–7. State programs to establish wellhead
protection areas
(a) State programs
The Governor or Governor’s designee of each
State shall, within 3 years of June 19, 1986, adopt
and submit to the Administrator a State program to protect wellhead areas within their jurisdiction from contaminants which may have
any adverse effect on the health of persons.
Each State program under this section shall, at
a minimum—
(1) specify the duties of State agencies, local
governmental entities, and public water supply systems with respect to the development
and implementation of programs required by
this section;
(2) for each wellhead, determine the wellhead protection area as defined in subsection
(e) of this section based on all reasonably
available
hydrogeologic
information
on
ground water flow, recharge and discharge and
other information the State deems necessary
to adequately determine the wellhead protection area;
(3) identify within each wellhead protection
area all potential anthropogenic sources of
contaminants which may have any adverse effect on the health of persons;
(4) describe a program that contains, as appropriate, technical assistance, financial assistance, implementation of control measures,
education,
training,
and
demonstration
projects to protect the water supply within
wellhead protection areas from such contaminants;
(5) include contingency plans for the location and provision of alternate drinking water
supplies for each public water system in the
event of well or wellfield contamination by
such contaminants; and
(6) include a requirement that consideration
be given to all potential sources of such contaminants within the expected wellhead area
of a new water well which serves a public
water supply system.
(b) Public participation
To the maximum extent possible, each State
shall establish procedures, including but not

Page 1005

TITLE 42—THE PUBLIC HEALTH AND WELFARE

limited to the establishment of technical and
citizens’ advisory committees, to encourage the
public to participate in developing the protection program for wellhead areas and source
water assessment programs under section 300j–13
of this title. Such procedures shall include notice and opportunity for public hearing on the
State program before it is submitted to the Administrator.
(c) Disapproval
(1) In general
If, in the judgment of the Administrator, a
State program or portion thereof under subsection (a) of this section is not adequate to
protect public water systems as required by
subsection (a) of this section or a State program under section 300j–13 of this title or section 300g–7(b) of this title does not meet the
applicable requirements of section 300j–13 of
this title or section 300g–7(b) of this title, the
Administrator shall disapprove such program
or portion thereof. A State program developed
pursuant to subsection (a) of this section shall
be deemed to be adequate unless the Administrator determines, within 9 months of the receipt of a State program, that such program
(or portion thereof) is inadequate for the purpose of protecting public water systems as required by this section from contaminants that
may have any adverse effect on the health of
persons. A State program developed pursuant
to section 300j–13 of this title or section
300g–7(b) of this title shall be deemed to meet
the applicable requirements of section 300j–13
of this title or section 300g–7(b) of this title
unless the Administrator determines within 9
months of the receipt of the program that
such program (or portion thereof) does not
meet such requirements. If the Administrator
determines that a proposed State program (or
any portion thereof) is disapproved, the Administrator shall submit a written statement
of the reasons for such determination to the
Governor of the State.
(2) Modification and resubmission
Within 6 months after receipt of the Administrator’s written notice under paragraph (1)
that any proposed State program (or portion
thereof) is disapproved, the Governor or Governor’s designee, shall modify the program
based upon the recommendations of the Administrator and resubmit the modified program to the Administrator.
(d) Federal assistance
After the date 3 years after June 19, 1986, no
State shall receive funds authorized to be appropriated under this section except for the purpose
of implementing the program and requirements
of paragraphs (4) and (6) of subsection (a) of this
section.
(e) ‘‘Wellhead protection area’’ defined
As used in this section, the term ‘‘wellhead
protection area’’ means the surface and subsurface area surrounding a water well or wellfield, supplying a public water system, through
which contaminants are reasonably likely to
move toward and reach such water well or wellfield. The extent of a wellhead protection area,

§ 300h–7

within a State, necessary to provide protection
from contaminants which may have any adverse
effect on the health of persons is to be determined by the State in the program submitted
under subsection (a) of this section. Not later
than one year after June 19, 1986, the Administrator shall issue technical guidance which
States may use in making such determinations.
Such guidance may reflect such factors as the
radius of influence around a well or wellfield,
the depth of drawdown of the water table by
such well or wellfield at any given point, the
time or rate of travel of various contaminants
in various hydrologic conditions, distance from
the well or wellfield, or other factors affecting
the likelihood of contaminants reaching the
well or wellfield, taking into account available
engineering pump tests or comparable data,
field reconnaissance, topographic information,
and the geology of the formation in which the
well or wellfield is located.
(f) Prohibitions
(1) Activities under other laws
No funds authorized to be appropriated
under this section may be used to support activities authorized by the Federal Water Pollution Control Act [33 U.S.C. 1251 et seq.], the
Solid Waste Disposal Act [42 U.S.C. 6901 et
seq.], the Comprehensive Environmental Response, Compensation, and Liability Act of
1980 [42 U.S.C. 9601 et seq.], or other sections of
this chapter.
(2) Individual sources
No funds authorized to be appropriated
under this section may be used to bring individual sources of contamination into compliance.
(g) Implementation
Each State shall make every reasonable effort
to implement the State wellhead area protection program under this section within 2 years
of submitting the program to the Administrator. Each State shall submit to the Administrator a biennial status report describing the
State’s progress in implementing the program.
Such report shall include amendments to the
State program for water wells sited during the
biennial period.
(h) Federal agencies
Each department, agency, and instrumentality of the executive, legislative, and judicial
branches of the Federal Government having jurisdiction over any potential source of contaminants identified by a State program pursuant to
the provisions of subsection (a)(3) of this section
shall be subject to and comply with all requirements of the State program developed according
to subsection (a)(4) of this section applicable to
such potential source of contaminants, both
substantive and procedural, in the same manner,
and to the same extent, as any other person is
subject to such requirements, including payment of reasonable charges and fees. The President may exempt any potential source under the
jurisdiction of any department, agency, or instrumentality in the executive branch if the
President determines it to be in the paramount
interest of the United States to do so. No such

§ 300h–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE

exemption shall be granted due to the lack of an
appropriation unless the President shall have
specifically requested such appropriation as part
of the budgetary process and the Congress shall
have failed to make available such requested appropriations.
(i) Additional requirement
(1) In general
In addition to the provisions of subsection
(a) of this section, States in which there are
more than 2,500 active wells at which annular
injection is used as of January 1, 1986, shall include in their State program a certification
that a State program exists and is being adequately enforced that provides protection
from contaminants which may have any adverse effect on the health of persons and which
are associated with the annular injection or
surface disposal of brines associated with oil
and gas production.
(2) ‘‘Annular injection’’ defined
For purposes of this subsection, the term
‘‘annular injection’’ means the reinjection of
brines associated with the production of oil or
gas between the production and surface casings of a conventional oil or gas producing
well.
(3) Review
The Administrator shall conduct a review of
each program certified under this subsection.
(4) Disapproval
If a State fails to include the certification
required by this subsection or if in the judgment of the Administrator the State program
certified under this subsection is not being
adequately enforced, the Administrator shall
disapprove the State program submitted under
subsection (a) of this section.
(j) Coordination with other laws
Nothing in this section shall authorize or require any department, agency, or other instrumentality of the Federal Government or State
or local government to apportion, allocate or
otherwise regulate the withdrawal or beneficial
use of ground or surface waters, so as to abrogate or modify any existing rights to water established pursuant to State or Federal law, including interstate compacts.
(k) Authorization of appropriations
Unless the State program is disapproved under
this section, the Administrator shall make
grants to the State for not less than 50 or more
than 90 percent of the costs incurred by a State
(as determined by the Administrator) in developing and implementing each State program
under this section. For purposes of making such
grants there is authorized to be appropriated not
more than the following amounts:
Fiscal year:
1987 ......................................................
1988 ......................................................
1989 ......................................................
1990 ......................................................
1991 ......................................................
1992–2003 ..............................................

Amount
$20,000,000
20,000,000
35,000,000
35,000,000
35,000,000
30,000,000.

(July 1, 1944, ch. 373, title XIV, § 1428, as added
and amended Pub. L. 99–339, title II, § 205, title

Page 1006

III, § 301(e), June 19, 1986, 100 Stat. 660, 664; Pub.
L. 104–182, title I, §§ 120(b), 132(b), title V,
§ 501(f)(4), Aug. 6, 1996, 110 Stat. 1650, 1674, 1692.)
REFERENCES IN TEXT
The Federal Water Pollution Control Act, referred to
in subsec. (f)(1), is act June 30, 1948, ch. 758, as amended
generally by Pub. L. 92–500, § 2, Oct. 18, 1972, 86 Stat. 816,
which is classified generally to chapter 26 (§ 1251 et seq.)
of Title 33, Navigation and Navigable Waters. For complete classification of this Act to the Code, see Short
Title note set out under section 1251 of Title 33 and
Tables.
The Solid Waste Disposal Act, referred to in subsec.
(f)(1), is title II of Pub. L. 89–272, Oct. 20, 1965, 79 Stat.
997, as amended generally by Pub. L. 94–580, § 2, Oct. 21,
1976, 90 Stat. 2795, which is classified generally to chapter 82 (§ 6901 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note
set out under section 6901 of this title and Tables.
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980, referred to in subsec. (f)(1), is Pub. L. 96–510, Dec. 11, 1980, 94 Stat. 2767,
as amended, which is classified principally to chapter
103 (§ 9601 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set
out under section 9601 of this title and Tables.
AMENDMENTS
1996—Pub. L. 104–182, § 501(f)(4), made technical
amendment to section catchline and subsec. (a) designation.
Subsec. (b). Pub. L. 104–182, § 132(b)(4), inserted before
period at end of first sentence ‘‘and source water assessment programs under section 300j–13 of this title’’.
Subsec. (c)(1). Pub. L. 104–182, § 132(b)(3), which directed substitution of ‘‘is disapproved’’ for ‘‘is inadequate’’ in third sentence, was executed by making the
substitution in fourth sentence to reflect the probable
intent of Congress and the amendment by Pub. L.
104–182, § 132(b)(2). See below.
Pub. L. 104–182, § 132(b)(2), inserted after second sentence ‘‘A State program developed pursuant to section
300j–13 of this title or section 300g–7(b) of this title shall
be deemed to meet the applicable requirements of section 300j–13 of this title or section 300g–7(b) of this title
unless the Administrator determines within 9 months
of the receipt of the program that such program (or
portion thereof) does not meet such requirements.’’
Pub. L. 104–182, § 132(b)(1), amended first sentence generally. Prior to amendment, first sentence read as follows: ‘‘If, in the judgment of the Administrator, a State
program (or portion thereof, including the definition of
a wellhead protection area), is not adequate to protect
public water systems as required by this section, the
Administrator shall disapprove such program (or portion thereof).’’
Subsec. (c)(2). Pub. L. 104–182, § 132(b)(3), substituted
‘‘is disapproved’’ for ‘‘is inadequate’’.
Subsec. (k). Pub. L. 104–182, § 120(b), inserted table
item relating to fiscal years 1992 through 2003.
1986—Subsec. (k). Pub. L. 99–339, § 301(e), added subsec.
(k).

§ 300h–8. State ground water protection grants
(a) In general
The Administrator may make a grant to a
State for the development and implementation
of a State program to ensure the coordinated
and comprehensive protection of ground water
resources within the State.
(b) Guidance
Not later than 1 year after August 6, 1996, and
annually thereafter, the Administrator shall
publish guidance that establishes procedures for
application for State ground water protection

Page 1007

TITLE 42—THE PUBLIC HEALTH AND WELFARE

program assistance and that identifies key elements of State ground water protection programs.
(c) Conditions of grants
(1) In general
The Administrator shall award grants to
States that submit an application that is approved by the Administrator. The Administrator shall determine the amount of a grant
awarded pursuant to this paragraph on the
basis of an assessment of the extent of ground
water resources in the State and the likelihood that awarding the grant will result in
sustained and reliable protection of ground
water quality.
(2) Innovative program grants
The Administrator may also award a grant
pursuant to this subsection for innovative programs proposed by a State for the prevention
of ground water contamination.
(3) Allocation of funds
The Administrator shall, at a minimum, ensure that, for each fiscal year, not less than 1
percent of funds made available to the Administrator by appropriations to carry out this
section are allocated to each State that submits an application that is approved by the
Administrator pursuant to this section.
(4) Limitation on grants
No grant awarded by the Administrator may
be used for a project to remediate ground
water contamination.
(d) Amount of grants
The amount of a grant awarded pursuant to
paragraph (1) shall not exceed 50 percent of the
eligible costs of carrying out the ground water
protection program that is the subject of the
grant (as determined by the Administrator) for
the 1-year period beginning on the date that the
grant is awarded. The State shall pay a State
share to cover the costs of the ground water protection program from State funds in an amount
that is not less than 50 percent of the cost of
conducting the program.
(e) Evaluations and reports
Not later than 3 years after August 6, 1996, and
every 3 years thereafter, the Administrator
shall evaluate the State ground water protection programs that are the subject of grants
awarded pursuant to this section and report to
the Congress on the status of ground water quality in the United States and the effectiveness of
State programs for ground water protection.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $15,000,000 for each of fiscal years 1997 through 2003.
(July 1, 1944, ch. 373, title XIV, § 1429, as added
Pub. L. 104–182, title I, § 131, Aug. 6, 1996, 110
Stat. 1672.)
PART D—EMERGENCY POWERS
§ 300i. Emergency powers
(a) Actions authorized against imminent and
substantial endangerment to health
Notwithstanding any other provision of this
subchapter the Administrator, upon receipt of

§ 300i–1

information that a contaminant which is present in or is likely to enter a public water system
or an underground source of drinking water, or
that there is a threatened or potential terrorist
attack (or other intentional act designed to disrupt the provision of safe drinking water or to
impact adversely the safety of drinking water
supplied to communities and individuals), which
may present an imminent and substantial endangerment to the health of persons, and that
appropriate State and local authorities have not
acted to protect the health of such persons, may
take such actions as he may deem necessary in
order to protect the health of such persons. To
the extent he determines it to be practicable in
light of such imminent endangerment, he shall
consult with the State and local authorities in
order to confirm the correctness of the information on which action proposed to be taken under
this subsection is based and to ascertain the action which such authorities are or will be taking. The action which the Administrator may
take may include (but shall not be limited to)
(1) issuing such orders as may be necessary to
protect the health of persons who are or may be
users of such system (including travelers), including orders requiring the provision of alternative water supplies by persons who caused or
contributed to the endangerment, and (2) commencing a civil action for appropriate relief, including a restraining order or permanent or
temporary injunction.
(b) Penalties for violations; separate offenses
Any person who violates or fails or refuses to
comply with any order issued by the Administrator under subsection (a)(1) of this section
may, in an action brought in the appropriate
United States district court to enforce such
order, be subject to a civil penalty of not to exceed $15,000 for each day in which such violation
occurs or failure to comply continues.
(July 1, 1944, ch. 373, title XIV, § 1431, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1680;
amended Pub. L. 99–339, title II, § 204, June 19,
1986, 100 Stat. 660; Pub. L. 104–182, title I, § 113(d),
Aug. 6, 1996, 110 Stat. 1636; Pub. L. 107–188, title
IV, § 403(2), June 12, 2002, 116 Stat. 687.)
AMENDMENTS
2002—Subsec. (a). Pub. L. 107–188, in first sentence, inserted ‘‘, or that there is a threatened or potential terrorist attack (or other intentional act designed to disrupt the provision of safe drinking water or to impact
adversely the safety of drinking water supplied to communities and individuals), which’’ after ‘‘drinking
water’’.
1996—Subsec. (b). Pub. L. 104–182 substituted ‘‘$15,000’’
for ‘‘$5,000’’.
1986—Subsec. (a). Pub. L. 99–339, § 204(1), (2), inserted
‘‘or an underground source of drinking water’’ after ‘‘to
enter a public water system’’ and ‘‘including orders requiring the provision of alternative water supplies by
persons who caused or contributed to the endangerment,’’ after ‘‘including travelers),’’.
Subsec. (b). Pub. L. 99–339, § 204(3), struck out ‘‘willfully’’ after ‘‘person who’’ and substituted ‘‘subject to
a civil penalty of not to exceed’’ for ‘‘fined not more
than’’.

§ 300i–1. Tampering with public water systems
(a) Tampering
Any person who tampers with a public water
system shall be imprisoned for not more than 20

§ 300i–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

years, or fined in accordance with title 18, or
both.
(b) Attempt or threat
Any person who attempts to tamper, or makes
a threat to tamper, with a public drinking water
system be imprisoned for not more than 10
years, or fined in accordance with title 18, or
both.
(c) Civil penalty
The Administrator may bring a civil action in
the appropriate United States district court (as
determined under the provisions of title 28)
against any person who tampers, attempts to
tamper, or makes a threat to tamper with a public water system. The court may impose on such
person a civil penalty of not more than $1,000,000
for such tampering or not more than $100,000 for
such attempt or threat.
(d) ‘‘Tamper’’ defined
For purposes of this section, the term ‘‘tamper’’ means—
(1) to introduce a contaminant into a public
water system with the intention of harming
persons; or
(2) to otherwise interfere with the operation
of a public water system with the intention of
harming persons.
(July 1, 1944, ch. 373, title XIV, § 1432, as added
Pub. L. 99–339, title I, § 108, June 19, 1986, 100
Stat. 651; amended Pub. L. 104–182, title V,
§ 501(f)(5), Aug. 6, 1996, 110 Stat. 1692; Pub. L.
107–188, title IV, § 403(3), June 12, 2002, 116 Stat.
687.)
AMENDMENTS
2002—Subsec. (a). Pub. L. 107–188, § 403(3)(A), substituted ‘‘20 years’’ for ‘‘5 years’’.
Subsec. (b). Pub. L. 107–188, § 403(3)(B), substituted ‘‘10
years’’ for ‘‘3 years’’.
Subsec. (c). Pub. L. 107–188, § 403(3)(C), (D), substituted
‘‘$1,000,000’’ for ‘‘$50,000’’ and ‘‘$100,000’’ for ‘‘$20,000’’.
1996—Pub. L. 104–182 made technical amendment to
section catchline and subsec. (a) designation.

§ 300i–2. Terrorist and other intentional acts
(a) Vulnerability assessments
(1) Each community water system serving a
population of greater than 3,300 persons shall
conduct an assessment of the vulnerability of its
system to a terrorist attack or other intentional
acts intended to substantially disrupt the ability of the system to provide a safe and reliable
supply of drinking water. The vulnerability assessment shall include, but not be limited to, a
review of pipes and constructed conveyances,
physical
barriers,
water
collection,
pretreatment, treatment, storage and distribution
facilities, electronic, computer or other automated systems which are utilized by the public
water system, the use, storage, or handling of
various chemicals, and the operation and maintenance of such system. The Administrator, not
later than August 1, 2002, after consultation
with appropriate departments and agencies of
the Federal Government and with State and
local governments, shall provide baseline information to community water systems required to
conduct vulnerability assessments regarding
which kinds of terrorist attacks or other intentional acts are the probable threats to—

Page 1008

(A) substantially disrupt the ability of the
system to provide a safe and reliable supply of
drinking water; or
(B) otherwise present significant public
health concerns.
(2) Each community water system referred to
in paragraph (1) shall certify to the Administrator that the system has conducted an assessment complying with paragraph (1) and shall
submit to the Administrator a written copy of
the assessment. Such certification and submission shall be made prior to:
(A) March 31, 2003, in the case of systems
serving a population of 100,000 or more.
(B) December 31, 2003, in the case of systems
serving a population of 50,000 or more but less
than 100,000.
(C) June 30, 2004, in the case of systems serving a population greater than 3,300 but less
than 50,000.
(3) Except for information contained in a certification under this subsection identifying the
system submitting the certification and the
date of the certification, all information provided to the Administrator under this subsection and all information derived therefrom
shall be exempt from disclosure under section
552 of title 5.
(4) No community water system shall be required under State or local law to provide an assessment described in this section to any State,
regional, or local governmental entity solely by
reason of the requirement set forth in paragraph
(2) that the system submit such assessment to
the Administrator.
(5) Not later than November 30, 2002, the Administrator, in consultation with appropriate
Federal law enforcement and intelligence officials, shall develop such protocols as may be
necessary to protect the copies of the assessments required to be submitted under this subsection (and the information contained therein)
from unauthorized disclosure. Such protocols
shall ensure that—
(A) each copy of such assessment, and all information contained in or derived from the assessment, is kept in a secure location;
(B) only individuals designated by the Administrator may have access to the copies of
the assessments; and
(C) no copy of an assessment, or part of an
assessment, or information contained in or derived from an assessment shall be available to
anyone other than an individual designated by
the Administrator.
At the earliest possible time prior to November
30, 2002, the Administrator shall complete the
development of such protocols for the purpose of
having them in place prior to receiving any vulnerability assessments from community water
systems under this subsection.
(6)(A) Except as provided in subparagraph (B),
any individual referred to in paragraph (5)(B)
who acquires the assessment submitted under
paragraph (2), or any reproduction of such assessment, or any information derived from such
assessment, and who knowingly or recklessly reveals such assessment, reproduction, or information other than—
(i) to an individual designated by the Administrator under paragraph (5),

Page 1009

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) for purposes of section 300j–4 of this title
or for actions under section 300i of this title,
or
(iii) for use in any administrative or judicial
proceeding to impose a penalty for failure to
comply with this section,
shall upon conviction be imprisoned for not
more than one year or fined in accordance with
the provisions of chapter 227 of title 18 applicable to class A misdemeanors, or both, and shall
be removed from Federal office or employment.
(B) Notwithstanding subparagraph (A), an individual referred to in paragraph (5)(B) who is an
officer or employee of the United States may
discuss the contents of a vulnerability assessment submitted under this section with a State
or local official.
(7) Nothing in this section authorizes any person to withhold any information from Congress
or from any committee or subcommittee of Congress.
(b) Emergency response plan
Each community water system serving a population greater than 3,300 shall prepare or revise,
where necessary, an emergency response plan
that incorporates the results of vulnerability assessments that have been completed. Each such
community water system shall certify to the
Administrator, as soon as reasonably possible
after the enactment of this section, but not
later than 6 months after the completion of the
vulnerability assessment under subsection (a) of
this section, that the system has completed such
plan. The emergency response plan shall include, but not be limited to, plans, procedures,
and identification of equipment that can be implemented or utilized in the event of a terrorist
or other intentional attack on the public water
system. The emergency response plan shall also
include actions, procedures, and identification
of equipment which can obviate or significantly
lessen the impact of terrorist attacks or other
intentional actions on the public health and the
safety and supply of drinking water provided to
communities and individuals. Community water
systems shall, to the extent possible, coordinate
with existing Local Emergency Planning Committees established under the Emergency Planning and Community Right-to-Know Act (42
U.S.C. 11001 et seq.) when preparing or revising
an emergency response plan under this subsection.
(c) Record maintenance
Each community water system shall maintain
a copy of the emergency response plan completed pursuant to subsection (b) of this section
for 5 years after such plan has been certified to
the Administrator under this section.
(d) Guidance to small public water systems
The Administrator shall provide guidance to
community water systems serving a population
of less than 3,300 persons on how to conduct vulnerability assessments, prepare emergency response plans, and address threats from terrorist
attacks or other intentional actions designed to
disrupt the provision of safe drinking water or
significantly affect the public health or significantly affect the safety or supply of drinking
water provided to communities and individuals.

§ 300i–2

(e) Funding
(1) There are authorized to be appropriated to
carry out this section not more than $160,000,000
for the fiscal year 2002 and such sums as may be
necessary for the fiscal years 2003 through 2005.
(2) The Administrator, in coordination with
State and local governments, may use funds
made available under paragraph (1) to provide financial assistance to community water systems
for purposes of compliance with the requirements of subsections (a) and (b) of this section
and to community water systems for expenses
and contracts designed to address basic security
enhancements of critical importance and significant threats to public health and the supply of
drinking water as determined by a vulnerability
assessment conducted under subsection (a) of
this section. Such basic security enhancements
may include, but shall not be limited to the following:
(A) the purchase and installation of equipment for detection of intruders;
(B) the purchase and installation of fencing,
gating, lighting, or security cameras;
(C) the tamper-proofing of manhole covers,
fire hydrants, and valve boxes;
(D) the rekeying of doors and locks;
(E) improvements to electronic, computer,
or other automated systems and remote security systems;
(F) participation in training programs, and
the purchase of training manuals and guidance
materials, relating to security against terrorist attacks;
(G) improvements in the use, storage, or
handling of various chemicals; and
(H) security screening of employees or contractor support services.
Funding under this subsection for basic security
enhancements shall not include expenditures for
personnel costs, or monitoring, operation, or
maintenance of facilities, equipment, or systems.
(3) The Administrator may use not more than
$5,000,000 from the funds made available under
paragraph (1) to make grants to community
water systems to assist in responding to and alleviating any vulnerability to a terrorist attack
or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water
(including sources of water for such systems)
which the Administrator determines to present
an immediate and urgent security need.
(4) The Administrator may use not more than
$5,000,000 from the funds made available under
paragraph (1) to make grants to community
water systems serving a population of less than
3,300 persons for activities and projects undertaken in accordance with the guidance provided
to such systems under subsection (d) of this section.
(July 1, 1944, ch. 373, title XIV, § 1433, as added
Pub. L. 107–188, title IV, § 401, June 12, 2002, 116
Stat. 682.)
REFERENCES IN TEXT
The Emergency Planning and Community Right-toKnow Act, referred to in subsec. (b), probably means
the Emergency Planning and Community Right-to-

§ 300i–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Know Act of 1986, Pub. L. 99–499, title III, Oct. 17, 1986,
100 Stat. 1728, which is classified generally to chapter
116 (§ 11001 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set
out under section 11001 of this title and Tables.

§ 300i–3. Contaminant prevention, detection and
response
(a) In general
The Administrator, in consultation with the
Centers for Disease Control and, after consultation with appropriate departments and agencies
of the Federal Government and with State and
local governments, shall review (or enter into
contracts or cooperative agreements to provide
for a review of) current and future methods to
prevent, detect and respond to the intentional
introduction of chemical, biological or radiological contaminants into community water
systems and source water for community water
systems, including each of the following:
(1) Methods, means and equipment, including real time monitoring systems, designed to
monitor and detect various levels of chemical,
biological, and radiological contaminants or
indicators of contaminants and reduce the
likelihood that such contaminants can be successfully introduced into public water systems
and source water intended to be used for
drinking water.
(2) Methods and means to provide sufficient
notice to operators of public water systems,
and individuals served by such systems, of the
introduction of chemical, biological or radiological contaminants and the possible effect of
such introduction on public health and the
safety and supply of drinking water.
(3) Methods and means for developing educational and awareness programs for community water systems.
(4) Procedures and equipment necessary to
prevent the flow of contaminated drinking
water to individuals served by public water
systems.
(5) Methods, means, and equipment which
could negate or mitigate deleterious effects on
public health and the safety and supply caused
by the introduction of contaminants into
water intended to be used for drinking water,
including an examination of the effectiveness
of various drinking water technologies in removing, inactivating, or neutralizing biological, chemical, and radiological contaminants.
(6) Biomedical research into the short-term
and long-term impact on public health of various chemical, biological and radiological contaminants that may be introduced into public
water systems through terrorist or other intentional acts.
(b) Funding
For the authorization of appropriations to
carry out this section, see section 300i–4(e) of
this title.
(July 1, 1944, ch. 373, title XIV, § 1434, as added
Pub. L. 107–188, title IV, § 402, June 12, 2002, 116
Stat. 685.)
CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.

Page 1010

§ 300i–4. Supply disruption prevention, detection
and response
(a) Disruption of supply or safety
The Administrator, in coordination with the
appropriate departments and agencies of the
Federal Government, shall review (or enter into
contracts or cooperative agreements to provide
for a review of) methods and means by which
terrorists or other individuals or groups could
disrupt the supply of safe drinking water or take
other actions against water collection, pretreatment, treatment, storage and distribution
facilities which could render such water significantly less safe for human consumption, including each of the following:
(1) Methods and means by which pipes and
other constructed conveyances utilized in public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable
public health standards.
(2) Methods and means by which collection,
pretreatment, treatment, storage and distribution facilities utilized or used in connection with public water systems and collection
and pretreatment storage facilities used in
connection with public water systems could be
destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.
(3) Methods and means by which pipes, constructed
conveyances,
collection,
pretreatment, treatment, storage and distribution systems that are utilized in connection
with public water systems could be altered or
affected so as to be subject to cross-contamination of drinking water supplies.
(4) Methods and means by which pipes, constructed
conveyances,
collection,
pretreatment, treatment, storage and distribution systems that are utilized in connection
with public water systems could be reasonably
protected from terrorist attacks or other acts
intended to disrupt the supply or affect the
safety of drinking water.
(5) Methods and means by which information
systems, including process controls and supervisory control and data acquisition and cyber
systems at community water systems could be
disrupted by terrorists or other groups.
(b) Alternative sources
The review under this section shall also include a review of the methods and means by
which alternative supplies of drinking water
could be provided in the event of the destruction, impairment or contamination of public
water systems.
(c) Requirements and considerations
In carrying out this section and section 300i–3
of this title—
(1) the Administrator shall ensure that reviews carried out under this section reflect the
needs of community water systems of various
sizes and various geographic areas of the
United States; and
(2) the Administrator may consider the vulnerability of, or potential for forced interruption of service for, a region or service area, including community water systems that provide service to the National Capital area.

Page 1011

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300j

(d) Information sharing
As soon as practicable after reviews carried
out under this section or section 300i–3 of this
title have been evaluated, the Administrator
shall disseminate, as appropriate as determined
by the Administrator, to community water systems information on the results of the project
through the Information Sharing and Analysis
Center, or other appropriate means.
(e) Funding
There are authorized to be appropriated to
carry out this section and section 300i–3 of this
title not more than $15,000,000 for the fiscal year
2002 and such sums as may be necessary for the
fiscal years 2003 through 2005.

preceding sentence of this paragraph shall not
apply when the Administrator for good cause
finds (and incorporates the finding with a brief
statement of reasons therefor in the order issued) that waiver of such requirements is necessary in order to protect the public health.
(3) Within 30 days after—
(A) the date a notice is published under
paragraph (2) in the Federal Register with respect to an application submitted under this
section for the issuance of a certification of
need, or
(B) the date on which such application is received if as authorized by the second sentence
of such paragraph no notice is published with
respect to such application,

(July 1, 1944, ch. 373, title XIV, § 1435, as added
Pub. L. 107–188, title IV, § 402, June 12, 2002, 116
Stat. 686.)

the Administrator shall take action either to
issue or deny the issuance of a certification of
need.
(c) Certification of need; issuance; executive orders; implementation of orders; equitable apportionment of orders; factors considered
(1) If the Administrator finds that the amount
of a chemical or substance necessary for an applicant under an application submitted under
this section to effectively treat water in a public
water system or in a public treatment works is
not reasonably available to the applicant or will
not be so available to him when required for the
effective treatment of such water, the Administrator shall issue a certification of need. Not
later than seven days following the issuance of
such certification, the President or his delegate
shall issue an order requiring the provision to
such person of such amounts of such chemical or
substance as the Administrator deems necessary
in the certification of need issued for such person. Such order shall apply to such manufactures, producers, processors, distributors, and
repackagers of such chemical or substance as
the President or his delegate deems necessary
and appropriate, except that such order may not
apply to any manufacturer, producer, or processor of such chemical or substance who manufactures, produces, or processes (as the case may
be) such chemical or substance solely for its own
use. Persons subject to an order issued under
this section shall be given a reasonable opportunity to consult with the President or his delegate with respect to the implementation of the
order.
(2) Orders which are to be issued under paragraph (1) to manufacturers, producers, and processors of a chemical or substance shall be equitably apportioned, as far as practicable, among
all manufacturers, producers, and processors of
such chemical or substance; and orders which
are to be issued under paragraph (1) to distributors and repackagers of a chemical or substance
shall be equitably apportioned, as far as practicable, among all distributors and repackagers
of such chemical or substance. In apportioning
orders issued under paragraph (1) to manufacturers, producers, processors, distributors, and
repackagers of chlorine, the President or his
delegate shall, in carrying out the requirements
of the preceding sentence, consider—
(A) the geographical relationships and established commercial relationships between such
manufacturers, producers, processors, dis-

PART E—GENERAL PROVISIONS
§ 300j. Assurances of availability of adequate supplies of chemicals necessary for treatment of
water
(a) Certification of need application
If any person who uses chlorine, activated carbon, lime, ammonia, soda ash, potassium permanganate, caustic soda, or other chemical or
substance for the purpose of treating water in
any public water system or in any public treatment works determines that the amount of such
chemical or substance necessary to effectively
treat such water is not reasonably available to
him or will not be so available to him when required for the effective treatment of such water,
such person may apply to the Administrator for
a certification (hereinafter in this section referred to as a ‘‘certification of need’’) that the
amount of such chemical or substance which
such person requires to effectively treat such
water is not reasonably available to him or will
not be so available when required for the effective treatment of such water.
(b) Application requirements; publication in Federal Register; waiver; certification, issuance
or denial
(1) An application for a certification of need
shall be in such form and submitted in such
manner as the Administrator may require and
shall (A) specify the persons the applicant determines are able to provide the chemical or substance with respect to which the application is
submitted, (B) specify the persons from whom
the applicant has sought such chemical or substance, and (C) contain such other information
as the Administrator may require.
(2) Upon receipt of an application under this
section, the Administrator shall (A) publish in
the Federal Register a notice of the receipt of
the application and a brief summary of it, (B)
notify in writing each person whom the President or his delegate (after consultation with the
Administrator) determines could be made subject to an order required to be issued upon the
issuance of the certification of need applied for
in such application, and (C) provide an opportunity for the submission of written comments
on such application. The requirements of the

§ 300j–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tributors, and repackagers and the persons for
whom the orders are issued;
(B) in the case of orders to be issued to producers of chlorine, the (i) amount of chlorine
historically supplied by each such producer to
treat water in public water systems and public
treatment works, and (ii) share of each such
producer of the total annual production of
chlorine in the United States; and
(C) such other factors as the President or his
delegate may determine are relevant to the
apportionment of orders in accordance with
the requirements of the preceding sentence.
(3) Subject to subsection (f) of this section,
any person for whom a certification of need has
been issued under this subsection may upon the
expiration of the order issued under paragraph
(1) upon such certification apply under this section for additional certifications.
(d) Breach of contracts; defense
There shall be available as a defense to any action brought for breach of contract in a Federal
or State court arising out of delay or failure to
provide, sell, or offer for sale or exchange a
chemical or substance subject to an order issued
pursuant to subsection (c)(1) of this section, that
such delay or failure was caused solely by compliance with such order.
(e) Penalties for noncompliance with orders;
temporary restraining orders and preliminary or permanent injunctions
(1) Whoever knowingly fails to comply with
any order issued pursuant to subsection (c)(1) of
this section shall be fined not more than $5,000
for each such failure to comply.
(2) Whoever fails to comply with any order issued pursuant to subsection (c)(1) of this section
shall be subject to a civil penalty of not more
than $2,500 for each such failure to comply.
(3) Whenever the Administrator or the President or his delegate has reason to believe that
any person is violating or will violate any order
issued pursuant to subsection (c)(1) of this section, he may petition a United States district
court to issue a temporary restraining order or
preliminary or permanent injunction (including
a mandatory injunction) to enforce the provision of such order.
(f) Termination date
No certification of need or order issued under
this section may remain in effect for more than
one year.
(July 1, 1944, ch. 373, title XIV, § 1441, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1680;
amended Pub. L. 95–190, § 7, Nov. 16, 1977, 91 Stat.
1396; Pub. L. 96–63, § 3, Sept. 6, 1979, 93 Stat. 411;
Pub. L. 99–339, title III, § 301(d), June 19, 1986, 100
Stat. 664; Pub. L. 104–182, title V, § 501(c), Aug. 6,
1996, 110 Stat. 1691.)
AMENDMENTS
1996—Subsec. (f). Pub. L. 104–182 inserted a period
after ‘‘year’’.
1986—Subsec. (f). Pub. L. 99–339 substituted ‘‘in effect
for more than one year’’ for ‘‘in effect— (1) for more
than one year, or (2) September 30, 1982, whichever occurs first.’’
1979—Subsec. (f)(2). Pub. L. 96–63 substituted ‘‘September 30, 1982’’ for ‘‘September 30, 1979’’.

Page 1012

1977—Subsec. (f). Pub. L. 95–190 substituted ‘‘September 30, 1979’’ for ‘‘June 30, 1977’’.
EX. ORD. NO. 11879. DELEGATION OF FUNCTIONS TO SECRETARY OF COMMERCE RELATING TO ORDERS FOR PROVISION OF CHEMICALS OR SUBSTANCES NECESSARY FOR
TREATMENT OF WATER
Ex. Ord. No. 11879, Sept. 17, 1975, 40 F.R. 43197, provided:
By virtue of the authority vested in me by Section
1441 of the Public Health Service Act, as amended by
the Safe Drinking Water Act [now Safe Drinking Water
Act of 1974] (88 Stat. 1680, 42 U.S.C. 300j), and as President of the United States, the Secretary of Commerce
is hereby delegated, with power to redelegate to agencies, officers and employees of the Government, the
functions of the President contained in said section
1441 [this section]. Those functions shall be administered under regulations or agreements which are identical or compatible with other regulations and agreements, including those provided pursuant to Executive
Order No. 10480, as amended [formerly set out as a note
under section 2153 of Title 50, Appendix, War and National Defense], for the allocation of similar chemicals
or substances.
GERALD R. FORD.

§ 300j–1. Research, technical assistance, information, training of personnel
(a) Specific powers and duties of Administrator
(1) The Administrator may conduct research,
studies, and demonstrations relating to the
causes, diagnosis, treatment, control, and prevention of physical and mental diseases and
other impairments of man resulting directly or
indirectly from contaminants in water, or to the
provision of a dependably safe supply of drinking water, including—
(A) improved methods (i) to identify and
measure the existence of contaminants in
drinking water (including methods which may
be used by State and local health and water
officials), and (ii) to identify the source of
such contaminants;
(B) improved methods to identify and measure the health effects of contaminants in
drinking water;
(C) new methods of treating raw water to
prepare it for drinking, so as to improve the
efficiency of water treatment and to remove
contaminants from water;
(D) improved methods for providing a dependably safe supply of drinking water, including improvements in water purification
and distribution, and methods of assessing the
health related hazards of drinking water; and
(E) improved methods of protecting underground water sources of public water systems
from contamination.
(2) INFORMATION AND RESEARCH FACILITIES.—In
carrying out this subchapter, the Administrator
is authorized to—
(A) collect and make available information
pertaining to research, investigations, and
demonstrations with respect to providing a dependably safe supply of drinking water, together with appropriate recommendations in
connection with the information; and
(B) make available research facilities of the
Agency to appropriate public authorities, institutions, and individuals engaged in studies
and research relating to this subchapter.

Page 1013

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) The Administrator shall carry out a study
of polychlorinated biphenyl contamination of
actual or potential sources of drinking water,
contamination of such sources by other substances known or suspected to be harmful to
public health, the effects of such contamination,
and means of removing, treating, or otherwise
controlling such contamination. To assist in
carrying out this paragraph, the Administrator
is authorized to make grants to public agencies
and private nonprofit institutions.
(4) The Administrator shall conduct a survey
and study of—
(A) disposal of waste (including residential
waste) which may endanger underground
water which supplies, or can reasonably be expected to supply, any public water systems,
and
(B) means of control of such waste disposal.
Not later than one year after December 16, 1974,
he shall transmit to the Congress the results of
such survey and study, together with such recommendations as he deems appropriate.
(5) The Administrator shall carry out a study
of methods of underground injection which do
not result in the degradation of underground
drinking water sources.
(6) The Administrator shall carry out a study
of methods of preventing, detecting, and dealing
with surface spills of contaminants which may
degrade underground water sources for public
water systems.
(7) The Administrator shall carry out a study
of virus contamination of drinking water
sources and means of control of such contamination.
(8) The Administrator shall carry out a study
of the nature and extent of the impact on underground water which supplies or can reasonably
be expected to supply public water systems of
(A) abandoned injection or extraction wells; (B)
intensive application of pesticides and fertilizers
in underground water recharge areas; and (C)
ponds, pools, lagoons, pits, or other surface disposal of contaminants in underground water recharge areas.
(9) The Administrator shall conduct a comprehensive study of public water supplies and
drinking water sources to determine the nature,
extent, sources of and means of control of contamination by chemicals or other substances
suspected of being carcinogenic. Not later than
six months after December 16, 1974, he shall
transmit to the Congress the initial results of
such study, together with such recommendations for further review and corrective action as
he deems appropriate.
(10) The Administrator shall carry out a study
of the reaction of chlorine and humic acids and
the effects of the contaminants which result
from such reaction on public health and on the
safety of drinking water, including any carcinogenic effect.
(b) Emergency situations
The Administrator is authorized to provide
technical assistance and to make grants to
States, or publicly owned water systems to assist in responding to and alleviating any emergency situation affecting public water systems
(including sources of water for such systems)

§ 300j–1

which the Administrator determines to present
substantial danger to the public health. Grants
provided under this subsection shall be used
only to support those actions which (i) are necessary for preventing, limiting or mitigating
danger to the public health in such emergency
situation and (ii) would not, in the judgment of
the Administrator, be taken without such emergency assistance. The Administrator may carry
out the program authorized under this subsection as part of, and in accordance with the
terms and conditions of, any other program of
assistance for environmental emergencies which
the Administrator is authorized to carry out
under any other provision of law. No limitation
on appropriations for any such other program
shall apply to amounts appropriated under this
subsection.
(c) Establishment of training programs and
grants for training; training fees
The Administrator shall—
(1) provide training for, and make grants for
training (including postgraduate training) of
(A) personnel of State agencies which have
primary enforcement responsibility and of
agencies or units of local government to which
enforcement responsibilities have been delegated by the State, and (B) personnel who
manage or operate public water systems, and
(2) make grants for postgraduate training of
individuals (including grants to educational
institutions for traineeships) for purposes of
qualifying such individuals to work as personnel referred to in paragraph (1).
(3) make grants to, and enter into contracts
with, any public agency, educational institution, and any other organization, in accordance with procedures prescribed by the Administrator, under which he may pay all or part of
the costs (as may be determined by the Administrator) of any project or activity which
is designed—
(A) to develop, expand, or carry out a program (which may combine training education and employment) for training persons
for occupations involving the public health
aspects of providing safe drinking water;
(B) to train inspectors and supervisory personnel to train or supervise persons in occupations involving the public health aspects
of providing safe drinking water; or
(C) to develop and expand the capability of
programs of States and municipalities to
carry out the purposes of this subchapter
(other than by carrying out State programs
of public water system supervision or underground water source protection (as defined
in section 300j–2(c) of this title)).
Reasonable fees may be charged for training
provided under paragraph (1)(B) to persons other
than personnel of State or local agencies but
such training shall be provided to personnel of
State or local agencies without charge.
(d) Authorization of appropriations
There are authorized to be appropriated to
carry out subsection (b) of this section not more
than $35,000,000 for the fiscal year 2002 and such
sums as may be necessary for each fiscal year
thereafter.

§ 300j–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Technical assistance
The Administrator may provide technical assistance to small public water systems to enable
such systems to achieve and maintain compliance with applicable national primary drinking
water regulations. Such assistance may include
circuit-rider and multi-State regional technical
assistance programs, training, and preliminary
engineering evaluations. The Administrator
shall ensure that technical assistance pursuant
to this subsection is available in each State.
Each nonprofit organization receiving assistance under this subsection shall consult with
the State in which the assistance is to be expended or otherwise made available before using
assistance to undertake activities to carry out
this subsection. There are authorized to be appropriated to the Administrator to be used for
such technical assistance $15,000,000 for each of
the fiscal years 1997 through 2003. No portion of
any State loan fund established under section
300j–12 of this title (relating to State loan funds)
and no portion of any funds made available
under this subsection may be used for lobbying
expenses. Of the total amount appropriated
under this subsection, 3 percent shall be used for
technical assistance to public water systems
owned or operated by Indian Tribes.
(July 1, 1944, ch. 373, title XIV, § 1442, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1682;
amended Pub. L. 95–190, §§ 2(a), 3(a), (b), (e)(1), 4,
9, 10(b), 13, Nov. 16, 1977, 91 Stat. 1393–1395,
1397–1399; Pub. L. 96–63, § 1, Sept. 6, 1979, 93 Stat.
411; Pub. L. 96–502, § 5, Dec. 5, 1980, 94 Stat. 2738;
Pub. L. 99–339, title I, § 107, title III, §§ 301(a), (g),
304(a), June 19, 1986, 100 Stat. 651, 663, 665, 667;
Pub. L. 104–66, title II, § 2021(h), Dec. 21, 1995, 109
Stat. 727; Pub. L. 104–182, title I, §§ 121, 122, Aug.
6, 1996, 110 Stat. 1651; Pub. L. 107–188, title IV,
§ 403(4), June 12, 2002, 116 Stat. 687.)
AMENDMENTS
2002—Subsec. (b). Pub. L. 107–188, § 403(4)(A), which directed substitution of ‘‘this subsection’’ for ‘‘this subparagraph’’, was executed by making the substitution
in three places to reflect the probable intent of Congress.
Subsec. (d). Pub. L. 107–188, § 403(4)(B), amended subsec. (d) generally, substituting provisions relating to
authorization of appropriations to carry out subsec. (b)
in fiscal year 2002 and subsequent fiscal years for provisions relating to authorization of appropriations to
carry out this section in fiscal year 1991 and earlier.
1996—Subsec. (a)(2). Pub. L. 104–182, § 121(4)(A), added
heading and text of par. (2) and struck out former par.
(2) which read as follows: ‘‘(2)(A) The Administrator
shall, to the maximum extent feasible, provide technical assistance to the States and municipalities in the
establishment and administration of public water system supervision programs (as defined in section
300j–2(c)(1) of this title).’’
Subsec. (a)(2)(B). Pub. L. 104–182, § 121(3), redesignated
subpar. (B) as subsec. (b) and transferred that subsec.
to appear after subsec. (a).
Subsec. (a)(3), (11). Pub. L. 104–182, § 121(4)(B), (C), redesignated par. (11) as (3), transferred that par. to appear before par. (4), and struck out former par. (3)
which provided that the Administrator was to conduct
studies, and make periodic reports to Congress, on the
costs of carrying out regulations prescribed under section 300g–1 of this title.
Subsec. (b). Pub. L. 104–182, § 121(2), (3), redesignated
subsec. (a)(2)(B) as subsec. (b), transferred that subsec.
to appear after subsec. (a), and struck out former sub-

Page 1014

sec. (b) which read as follows: ‘‘In carrying out this
subchapter, the Administrator is authorized to—
‘‘(1) collect and make available information pertaining to research, investigations, and demonstrations with respect to providing a dependably safe supply of drinking water together with appropriate recommendations in connection therewith;
‘‘(2) make available research facilities of the Agency to appropriate public authorities, institutions, and
individuals engaged in studies and research relating
to the purposes of this subchapter;’’.
Subsecs. (b)(3), (c)(3). Pub. L. 104–182, § 121(1), which
directed redesignation of subsec. (b)(3) as par. (3) of
subsec. (d) and transfer of that par. to follow par. (2) of
subsec. (d), was executed by redesignating subsec. (b)(3)
as par. (3) of subsec. (c) and transferring that par. to
follow par. (2) of subsec. (c) to reflect the probable intent of Congress and the redesignation of subsec. (d) as
(c) by Pub. L. 104–66. See 1995 Amendment note below.
Moreover, subsec. (d) does not have any pars.
Subsec. (e). Pub. L. 104–182, § 122, amended subsec. (e)
generally. Prior to amendment, subsec. (e) read as follows: ‘‘The Administrator is authorized to provide technical assistance to small public water systems to enable such systems to achieve and maintain compliance
with national drinking water regulations. Such assistance may include ‘circuit-rider’ programs, training,
and preliminary engineering studies. There are authorized to be appropriated to carry out this subsection
$10,000,000 for each of the fiscal years 1987 through 1991.
Not less than the greater of—
‘‘(1) 3 percent of the amounts appropriated under
this subsection, or
‘‘(2) $280,000
shall be utilized for technical assistance to public
water systems owned or operated by Indian tribes.’’
1995—Subsecs. (c) to (g). Pub. L. 104–66 redesignated
subsecs. (d), (f), and (g) as (c), (d), and (e), respectively,
and struck out former subsec. (c) which read as follows:
‘‘Not later than eighteen months after November 16,
1977, the Administrator shall submit a report to Congress on the present and projected future availability of
an adequate and dependable supply of safe drinking
water to meet present and projected future need. Such
report shall include an analysis of the future demand
for drinking water and other competing uses of water,
the availability and use of methods to conserve water
or reduce demand, the adequacy of present measures to
assure adequate and dependable supplies of safe drinking water, and the problems (financial, legal, or other)
which need to be resolved in order to assure the availability of such supplies for the future. Existing information and data complied by the National Water Commission and others shall be utilized to the extent possible.’’
1986—Subsec. (e). Pub. L. 99–339, § 304(a), struck out
subsec. (e) which authorized the Administrator to make
grants to public water systems which are required,
under State or local law, to meet standards relating to
drinking turbidity which are more stringent than the
standards in effect under this subchapter.
Subsec. (f). Pub. L. 99–339, § 301(a), authorized appropriations to carry out subsec. (a)(2)(B) of this section
for fiscal years 1987 to 1991 and to carry out provisions
of this section other than subsecs. (a)(2)(B) and (g) and
provisions relating to research for fiscal years 1987 to
1991.
Subsec. (g). Pub. L. 99–339, § 301(g), authorized appropriations to carry out this subsection of $10,000,000 for
each of fiscal years 1987 through 1991 and specified
amount to be utilized for public water systems owned
or operated by Indian tribes.
Pub. L. 99–339, § 107 added subsec. (g).
1980—Subsecs. (e), (f). Pub. L. 96–502 added subsec. (e)
and redesignated former subsec. (e) as (f).
1979—Subsec. (e). Pub. L. 96–63 authorized appropriations of $21,405,000 for fiscal year ending Sept. 30, 1980,
$30,000,000 for fiscal year ending Sept. 30, 1981, and
$35,000,000 for fiscal year ending Sept. 30, 1982 for purposes other than those of subsec. (a)(2)(B) of this sec-

Page 1015

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion and for purposes of subsec. (a)(2)(B) of this section,
$8,000,000 for fiscal years 1980 through 1982.
1977—Subsec. (a)(2). Pub. L. 95–190, §§ 9, 13, designated
existing provisions as subpar. (A), added subpar. (B)
and, in subpar. (B) as added, substituted provisions authorizing Administrator to make grants and provide
technical assistance for any emergency situation affecting public water systems and criteria for such
grants and assistance for provisions authorizing Administrator to make grants and provide technical assistance for any emergency situation respecting drinking water and criteria for determination of such situations.
Subsec. (a)(3). Pub. L. 95–190, § 3(a), designated existing provisions as subpar. (A) and added subpar. (B).
Subsec. (a)(10), (11). Pub. L. 95–190, § 3(e)(1), added
pars. (10) and (11).
Subsec. (b)(3)(C). Pub. L. 95–190, § 10(b), substituted
‘‘300j–2(c)’’ for ‘‘300j–2(d)’’.
Subsecs. (c), (d). Pub. L. 95–190, §§ 3(b), 4, added subsecs. (c) and (d). Former subsec. (c) redesignated (e).
Subsec. (e). Pub. L. 95–190, §§ 2(a), 3(b), redesignated
former subsec. (c) as (e) and inserted provisions authorizing appropriations for fiscal years 1978 and 1979, and
provisions relating to appropriations for subsec.
(a)(2)(B) of this section and for research.
SCIENTIFIC RESEARCH REVIEW
Section 202 of Pub. L. 104–182 provided that:
‘‘(a) IN GENERAL.—The Administrator shall—
‘‘(1) develop a strategic plan for drinking water research activities throughout the Environmental Protection Agency (in this section referred to as the
‘Agency’);
‘‘(2) integrate that strategic plan into ongoing
Agency planning activities; and
‘‘(3) review all Agency drinking water research to
ensure the research—
‘‘(A) is of high quality; and
‘‘(B) does not duplicate any other research being
conducted by the Agency.
‘‘(b) PLAN.—The Administrator shall transmit the
plan to the Committees on Commerce and Science of
the House of Representatives and the Committee on
Environment and Public Works of the Senate and the
plan shall be made available to the public.’’
NATIONAL CENTER FOR GROUND WATER RESEARCH
Section 203 of Pub. L. 104–182 provided that: ‘‘The Administrator of the Environmental Protection Agency,
acting through the Robert S. Kerr Environmental Research Laboratory, is authorized to reestablish a partnership between the Laboratory and the National Center for Ground Water Research, a university consortium, to conduct research, training, and technology
transfer for ground water quality protection and restoration. No funds are authorized by this section.’’
COMPARATIVE HEALTH EFFECTS ASSESSMENT
Section 304(b) of Pub. L. 99–339 provided that: ‘‘The
Administrator of the Environmental Protection Agency shall conduct a comparative health effects assessment, using available data, to compare the public
health effects (both positive and negative) associated
with water treatment chemicals and their byproducts
to the public health effects associated with contaminants found in public water supplies. Not later than 18
months after the date of the enactment of this Act
[June 19, 1986], the Administrator shall submit a report
to the Congress setting forth the results of such assessment.’’

§ 300j–2. Grants for State programs
(a) Public water systems supervision programs;
applications for grants; allotment of sums;
waiver of grant restrictions; notice of approval or disapproval of application; authorization of appropriations
(1) From allotments made pursuant to paragraph (4), the Administrator may make grants

§ 300j–2

to States to carry out public water system supervision programs.
(2) No grant may be made under paragraph (1)
unless an application therefor has been submitted to the Administrator in such form and manner as he may require. The Administrator may
not approve an application of a State for its
first grant under paragraph (1) unless he determines that the State—
(A) has established or will establish within
one year from the date of such grant a public
water system supervision program, and
(B) will, within that one year, assume primary enforcement responsibility for public
water systems within the State.
No grant may be made to a State under paragraph (1) for any period beginning more than
one year after the date of the State’s first grant
unless the State has assumed and maintains primary enforcement responsibility for public
water systems within the State. The prohibitions contained in the preceding two sentences
shall not apply to such grants when made to Indian Tribes.
(3) A grant under paragraph (1) shall be made
to cover not more than 75 per centum of the
grant recipient’s costs (as determined under regulations of the Administrator) in carrying out,
during the one-year period beginning on the
date the grant is made, a public water system
supervision program.
(4) In each fiscal year the Administrator shall,
in accordance, with regulations, allot the sums
appropriated for such year under paragraph (5)
among the States on the basis of population,
geographical area, number of public water systems, and other relevant factors. No State shall
receive less than 1 per centum of the annual appropriation for grants under paragraph (1): Provided, That the Administrator may, by regulation, reduce such percentage in accordance with
the criteria specified in this paragraph: And provided further, That such percentage shall not
apply to grants allotted to Guam, American
Samoa, or the Virgin Islands.
(5) The prohibition contained in the last sentence of paragraph (2) may be waived by the Administrator with respect to a grant to a State
through fiscal year 1979 but such prohibition
may only be waived if, in the judgment of the
Administrator—
(A) the State is making a diligent effort to
assume and maintain primary enforcement responsibility for public water systems within
the State;
(B) the State has made significant progress
toward assuming and maintaining such primary enforcement responsibility; and
(C) there is reason to believe the State will
assume such primary enforcement responsibility by October 1, 1979.
The amount of any grant awarded for the fiscal
years 1978 and 1979 pursuant to a waiver under
this paragraph may not exceed 75 per centum of
the allotment which the State would have received for such fiscal year if it had assumed and
maintained such primary enforcement responsibility. The remaining 25 per centum of the
amount allotted to such State for such fiscal
year shall be retained by the Administrator, and

§ 300j–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Administrator may award such amount to
such State at such time as the State assumes
such responsibility before the beginning of fiscal
year 1980. At the beginning of each fiscal years
1979 and 1980 the amounts retained by the Administrator for any preceding fiscal year and
not awarded by the beginning of fiscal year 1979
or 1980 to the States to which such amounts
were originally allotted may be removed from
the original allotment and reallotted for fiscal
year 1979 or 1980 (as the case may be) to States
which have assumed primary enforcement responsibility by the beginning of such fiscal year.
(6) The Administrator shall notify the State of
the approval or disapproval of any application
for a grant under this section—
(A) within ninety days after receipt of such
application, or
(B) not later than the first day of the fiscal
year for which the grant application is made,
whichever is later.
(7) AUTHORIZATION.—For the purpose of making grants under paragraph (1), there are authorized to be appropriated $100,000,000 for each of
fiscal years 1997 through 2003.
(8) RESERVATION OF FUNDS BY THE ADMINISTRATOR.—If the Administrator assumes the primary enforcement responsibility of a State public water system supervision program, the Administrator may reserve from funds made available pursuant to this subsection an amount
equal to the amount that would otherwise have
been provided to the State pursuant to this subsection. The Administrator shall use the funds
reserved pursuant to this paragraph to ensure
the full and effective administration of a public
water system supervision program in the State.
(9) STATE LOAN FUNDS.—
(A) RESERVATION OF FUNDS.—For any fiscal
year for which the amount made available to
the Administrator by appropriations to carry
out this subsection is less than the amount
that the Administrator determines is necessary to supplement funds made available
pursuant to paragraph (8) to ensure the full
and effective administration of a public water
system supervision program in a State, the
Administrator may reserve from the funds
made available to the State under section
300j–12 of this title (relating to State loan
funds) an amount that is equal to the amount
of the shortfall. This paragraph shall not
apply to any State not exercising primary enforcement responsibility for public water systems as of August 6, 1996.
(B) DUTY OF ADMINISTRATOR.—If the Administrator reserves funds from the allocation of
a State under subparagraph (A), the Administrator shall carry out in the State each of the
activities that would be required of the State
if the State had primary enforcement authority under section 300g–2 of this title.
(b) Underground water source protection programs; applications for grants; allotment of
sums; authorization of appropriations
(1) From allotments made pursuant to paragraph (4), the Administrator may make grants
to States to carry out underground water source
protection programs.
(2) No grant may be made under paragraph (1)
unless an application therefor has been submit-

Page 1016

ted to the Administrator in such form and manner as he may require. No grant may be made to
any State under paragraph (1) unless the State
has assumed primary enforcement responsibility
within two years after the date the Administrator promulgates regulations for State underground injection control programs under section
300h of this title. The prohibition contained in
the preceding sentence shall not apply to such
grants when made to Indian Tribes.
(3) A grant under paragraph (1) shall be made
to cover not more than 75 per centum of the
grant recipient’s cost (as determined under regulations of the Administrator) in carrying out,
during the one-year period beginning on the
date the grant is made, and underground water
source protection program.
(4) In each fiscal year the Administrator shall,
in accordance with regulations, allot the sums
appropriated for such year under paragraph (5)
among the States on the basis of population,
geographical area, and other relevant factors.
(5) For purposes of making grants under paragraph (1) there are authorized to be appropriated
$5,000,000 for the fiscal year ending June 30, 1976,
$7,500,000 for the fiscal year ending June 30, 1977,
$10,000,000 for each of the fiscal years 1978 and
1979, $7,795,000 for the fiscal year ending September 30, 1980, $18,000,000 for the fiscal year ending
September 30, 1981, and $21,000,000 for the fiscal
year ending September 30, 1982. For the purpose
of making grants under paragraph (1) there are
authorized to be appropriated not more than the
following amounts:
Fiscal year:
1987 ......................................................
1988 ......................................................
1989 ......................................................
1990 ......................................................
1991 ......................................................
1992–2003 ..............................................

Amount
$19,700,000
19,700,000
20,850,000
20,850,000
20,850,000
15,000,000.

(c) Definitions
For purposes of this section:
(1) The term ‘‘public water system supervision program’’ means a program for the
adoption and enforcement of drinking water
regulations (with such variances and exemptions from such regulations under conditions
and in a manner which is not less stringent
than the conditions under, and the manner in,
which variances and exemptions may be granted under sections 300g–4 and 300g–5 of this
title) which are no less stringent than the national primary drinking water regulations
under section 300g–1 of this title, and for keeping records and making reports required by
section 300g–2(a)(3) of this title.
(2) The term ‘‘underground water source protection program’’ means a program for the
adoption and enforcement of a program which
meets the requirements of regulations under
section 300h of this title, and for keeping
records and making reports required by section 300h–1(b)(1)(A)(ii) of this title. Such term
includes, where applicable, a program which
meets the requirements of section 300h–4 of
this title.
(d) New York City watershed protection program
(1) In general
The Administrator is authorized to provide
financial assistance to the State of New York

Page 1017

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for demonstration projects implemented as
part of the watershed program for the protection and enhancement of the quality of source
waters of the New York City water supply system, including projects that demonstrate, assess, or provide for comprehensive monitoring
and surveillance and projects necessary to
comply with the criteria for avoiding filtration contained in 40 CFR 141.71. Demonstration projects which shall be eligible for financial assistance shall be certified to the Administrator by the State of New York as satisfying the purposes of this subsection. In certifying projects to the Administrator, the State of
New York shall give priority to monitoring
projects that have undergone peer review.
(2) Report
Not later than 5 years after the date on
which the Administrator first provides assistance pursuant to this paragraph, the Governor
of the State of New York shall submit a report
to the Administrator on the results of projects
assisted.
(3) Matching requirements
Federal assistance provided under this subsection shall not exceed 50 percent of the total
cost of the protection program being carried
out for any particular watershed or ground
water recharge area.
(4) Authorization
There are authorized to be appropriated to
the Administrator to carry out this subsection
for each of fiscal years 2003 through 2010,
$15,000,000 for the purpose of providing assistance to the State of New York to carry out
paragraph (1).
(July 1, 1944, ch. 373, title XIV, § 1443, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1684;
amended Pub. L. 95–190, §§ 2(b), (c), 5(a), Nov. 16,
1977, 91 Stat. 1393, 1395; Pub. L. 96–63, § 2, Sept. 6,
1979, 93 Stat. 411; Pub. L. 96–502, §§ 2(c), 4(d), Dec.
5, 1980, 94 Stat. 2738; Pub. L. 99–339, title III,
§§ 301(b), (c), 302(d), June 19, 1986, 100 Stat. 664,
666; Pub. L. 104–182, title I, §§ 120(c), 124, 128, Aug.
6, 1996, 110 Stat. 1651, 1653, 1659; Pub. L. 108–328,
§ 1, Oct. 16, 2004, 118 Stat. 1273.)
AMENDMENTS
2004—Subsec. (d)(4). Pub. L. 108–328 substituted ‘‘2003
through 2010’’ for ‘‘1997 through 2003’’.
1996—Subsec. (a)(7). Pub. L. 104–182, § 124(1), inserted
heading and amended text generally. Prior to amendment, text read as follows: ‘‘For purposes of making
grants under paragraph (1) there are authorized to be
appropriated $15,000,000 for the fiscal year ending June
30, 1976, $25,000,000 for the fiscal year ending June 30,
1977, $35,000,000 for fiscal year 1978, $45,000,000 for fiscal
year 1979, $29,450,000 for the fiscal year ending September 30, 1980, $32,000,000 for the fiscal year ending September 30, 1981, and $34,000,000 for the fiscal year ending
September 30, 1982. For the purposes of making grants
under paragraph (1) there are authorized to be appropriated not more than the following amounts:
‘‘Fiscal year:
Amount
1987....................................................... $37,200,000
1988....................................................... 37,200,000
1989....................................................... 40,150,000
1990....................................................... 40,150,000
1991....................................................... 40,150,000’’.
Subsec. (a)(8), (9). Pub. L. 104–182, § 124(2), added pars.
(8) and (9).

§ 300j–3

Subsec. (b)(5). Pub. L. 104–182, § 120(c), inserted table
item relating to fiscal years 1992 through 2003.
Subsec. (d). Pub. L. 104–182, § 128, added subsec. (d).
1986—Subsec. (a)(2). Pub. L. 99–339, § 302(d)(1), inserted
provision that prohibitions contained in preceding two
sentences not apply to such grants when made to Indian Tribes.
Subsec. (a)(7). Pub. L. 99–339, § 301(b), authorized appropriations for grants under par. (1) of not more than
$37,200,000 for fiscal years 1987 and 1988 and of not more
than $40,150,000 for fiscal years 1989 to 1991.
Subsec. (b)(2). Pub. L. 99–339, § 302(d)(2), inserted provision that prohibition contained in preceding sentence
not apply to such grants when made to Indian Tribes.
Subsec. (b)(5). Pub. L. 99–339, § 301(c), authorized appropriations for grants under par. (1) of not more than
$19,700,000 for fiscal years 1987 and 1988 and of not more
than $20,850,000 for fiscal years 1989 to 1991.
1980—Subsec. (b)(2). Pub. L. 96–502, § 4(d), substituted
provisions that no grant may be made to any State
under par. (1) unless the State has assumed primary enforcement responsibility within two years after the
date the Administrator promulgates regulations for
State underground injection control programs under
section 300h of this title for provisions that the Administrator may not approve an application of a State for
its first grant under par. (1) unless he determines that
the State has established or will establish within two
years from the date of such grant an underground
water source protection, and will, within such two
years, assume primary enforcement responsibility for
underground water sources within the State and that
no grant may be made to a State under par. (1) for any
period beginning more than two years after the date of
the State’s first grant unless the State has assumed
and maintains primary enforcement responsibility for
underground water sources within the State.
Subsec. (c)(2). Pub. L. 96–502, § 2(c), inserted provision
that such term includes, where applicable, a program
which meets requirements of section 300h–4 of this
title.
1979—Subsec. (a)(7). Pub. L. 96–63, § 2(a), authorized
appropriation of $29,450,000, $32,000,000, and $34,000,000
for fiscal years ending Sept. 30, 1980, through 1982, respectively.
Subsec. (b)(5). Pub. L. 96–63, § 2(b), authorized appropriation of $7,795,000, $18,000,000, and $21,000,000 for fiscal
years ending Sept. 30, 1980, through 1982, respectively.
1977—Subsec. (a)(5), (6). Pub. L. 95–190, § 5(a), added
pars. (5) and (6). Former par. (5) redesignated (7).
Subsec. (a)(7). Pub. L. 95–190, §§ 2(b), 5(a), redesignated
former par. (5) as (7) and authorized appropriations for
fiscal years 1978 and 1979.
Subsec. (b)(5). Pub. L. 95–190, § 2(c), inserted provisions authorizing appropriations for fiscal years 1978
and 1979.

§ 300j–3. Special project grants and guaranteed
loans
(a) Special study and demonstration project
grants
The Administrator may make grants to any
person for the purposes of—
(1) assisting in the development and demonstration (including construction) of any
project which will demonstrate a new or improved method, approach, or technology, for
providing a dependably safe supply of drinking
water to the public; and
(2) assisting in the development and demonstration (including construction) of any
project which will investigate and demonstrate health implications involved in the
reclamation, recycling, and reuse of waste waters for drinking and the processes and methods for the preparation of safe and acceptable
drinking water.

§ 300j–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Limitations
Grants made by the Administrator under this
section shall be subject to the following limitations:
(1) Grants under this section shall not exceed 662⁄3 per centum of the total cost of construction of any facility and 75 per centum of
any other costs, as determined by the Administrator.
(2) Grants under this section shall not be
made for any project involving the construction or modification of any facilities for any
public water system in a State unless such
project has been approved by the State agency
charged with the responsibility for safety of
drinking water (or if there is no such agency
in a State, by the State health authority).
(3) Grants under this section shall not be
made for any project unless the Administrator
determines, after consulting the National
Drinking Water Advisory Council, that such
project will serve a useful purpose relating to
the development and demonstration of new or
improved techniques, methods, or technologies
for the provision of safe water to the public for
drinking.
(4) Priority for grants under this section
shall be given where there are known or potential public health hazards which require advanced technology for the removal of particles
which are too small to be removed by ordinary
treatment technology.
(c) Authorization of appropriations
For the purposes of making grants under subsections (a) and (b) of this section there are authorized to be appropriated $7,500,000 for the fiscal year ending June 30, 1975; and $7,500,000 for
the fiscal year ending June 30, 1976; and
$10,000,000 for the fiscal year ending June 30,
1977.
(d) Loan guarantees to public water systems;
conditions; indebtedness limitation; regulations
The Administrator during the fiscal years ending June 30, 1975, and June 30, 1976, shall carry
out a program of guaranteeing loans made by
private lenders to small public water systems
for the purpose of enabling such systems to
meet national primary drinking water regulations prescribed under section 300g–1 of this
title. No such guarantee may be made with respect to a system unless (1) such system cannot
reasonably obtain financial assistance necessary
to comply with such regulations from any other
source, and (2) the Administrator determines
that any facilities constructed with a loan guaranteed under this subsection is not likely to be
made obsolete by subsequent changes in primary
regulations. The aggregate amount of indebtedness guaranteed with respect to any system may
not exceed $50,000. The aggregate amount of indebtedness guaranteed under this subsection
may not exceed $50,000,000. The Administrator
shall prescribe regulations to carry out this subsection.
(July 1, 1944, ch. 373, title XIV, § 1444, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1685;
amended Pub. L. 99–339, title I, § 101(c)(3), June
19, 1986, 100 Stat. 646.)

Page 1018

AMENDMENTS
1986—Subsec. (d). Pub. L. 99–339 struck out ‘‘(including interim regulations)’’ before ‘‘prescribed’’ in first
sentence.

§ 300j–3a. Grants to public sector agencies
(a) Assistance for development and demonstration projects
The Administrator of the Environmental Protection Agency shall offer grants to public sector agencies for the purposes of—
(1) assisting in the development and demonstration (including construction) of any
project which will demonstrate a new or improved method, approach, or technology for
providing a dependably safe supply of drinking
water to the public; and
(2) assisting in the development and demonstration (including construction) of any
project which will investigate and demonstrate health and conservation implications
involved in the reclamation, recycling, and
reuse of wastewaters for drinking and agricultural use or the processes and methods for the
preparation of safe and acceptable drinking
water.
(b) Limitations
Grants made by the Administrator under this
section shall be subject to the following limitations:
(1) Grants under this section shall not exceed 662⁄3 per centum of the total cost of construction of any facility and 75 per centum of
any other costs, as determined by the Administrator.
(2) Grants under this section shall not be
made for any project involving the construction or modification of any facilities for any
public water system in a State unless such
project has been approved by the State agency
charged with the responsibility for safety of
drinking water (or if there is no such agency
in a State, by the State health authority).
(3) Grants under this section shall not be
made for any project unless the Administrator
determines, after consultation, that such
project will serve a useful purpose relating to
the development and demonstration of new or
improved techniques, methods, or technologies
for the provision of safe water to the public for
drinking.
(c) Authorization of appropriations
There are authorized to be appropriated for
the purposes of this section $25,000,000 for fiscal
year 1978.
(Pub. L. 95–155, § 5, Nov. 8, 1977, 91 Stat. 1258;
Pub. L. 95–477, § 7(a)(1), Oct. 18, 1978, 92 Stat.
1511.)
CODIFICATION
Section was enacted as part of the Environmental Research, Development, and Demonstration Authorization Act of 1978, and not as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
1978—Subsec. (a)(2). Pub. L. 95–477 inserted ‘‘agricultural use or’’ after ‘‘drinking and’’.

Page 1019

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300j–3c

EFFECTIVE DATE OF 1978 AMENDMENT

CODIFICATION

Section 7(a)(2) of Pub. L. 95–477 provided that: ‘‘This
subsection [amending this section] shall become effective October 1, 1978.’’

Section was enacted as part of the Environmental Research, Development, and Demonstration Authorization Act of 1979, and not as part of the Public Health
Service Act which comprises this chapter.

§ 300j–3b. Contaminant standards or treatment
technique guidelines
(1) Not later than nine months after October
18, 1978, the Administrator shall promulgate
guidelines establishing supplemental standards
or treatment technique requirements for microbiological, viral, radiological, organic, and inorganic contaminants, which guidelines shall be
conditions, as provided in paragraph (2), of any
grant for a demonstration project for water reclamation, recycling, and reuse funded under section 300j–3a of this title or under section
300j–3(a)(2) of this title, where such project involves direct human consumption of treated
wastewater. Such guidelines shall provide for
sufficient control of each such contaminant,
such that in the Administrator’s judgement, no
adverse effects on the health of persons may reasonably be anticipated to occur, allowing an
adequate margin of safety.
(2) A grant referred to in paragraph (1) for a
project which involves direct human consumption of treated wastewater may be awarded on
or after the date of promulgation of guidelines
under this section only if the applicant demonstrates to the satisfaction of the Administrator that the project—
(A) will comply with all national primary
drinking water regulations under section
300g–1 of this title;
(B) will comply with all guidelines under
this section; and
(C) will in other respects provide safe drinking water.
Any such grant awarded before the date of promulgation of such guidelines shall be conditioned on the applicant’s agreement to comply
to the maximum feasible extent with such
guidelines as expeditiously as practicable following the date of promulgation thereof.
(3) Guidelines under this section may, in the
discretion of the Administrator—
(A) be nationally and uniformly applicable
to all projects funded under section 300j–3a of
this title or section 300j–1(a)(2) 1 of this title;
(B) vary for different classes or categories of
such projects (as determined by the Administrator);
(C) be established and applicable on a project-by-project basis; or
(D) any combination of the above.
(4) Nothing in this section shall be construed
to prohibit or delay the award of any grant referred to in paragraph (1) prior to the date of
promulgation of such guidelines.
(Pub. L. 95–477, § 7(b), Oct. 18, 1978, 92 Stat. 1511.)
REFERENCES IN TEXT
Section 300j–1(a)(2) of this title, referred to in par.
(3)(A), was amended by Pub. L. 104–182, title I, § 121(3),
(4)(A), Aug. 6, 1996, 110 Stat. 1651, to redesignate par.
(2)(B) as subsec. (b) of section 300j–1, strike par. (2)(A),
and add a new par. (2) relating to information and research facilities.
1 See

References in Text note below.

§ 300j–3c. National assistance program for water
infrastructure and watersheds
(a) Technical and financial assistance
The Administrator of the Environmental Protection Agency may provide technical and financial assistance in the form of grants to States
(1) for the construction, rehabilitation, and improvement of water supply systems, and (2) consistent with nonpoint source management programs established under section 1329 of title 33,
for source water quality protection programs to
address pollutants in navigable waters for the
purpose of making such waters usable by water
supply systems.
(b) Limitation
Not more than 30 percent of the amounts appropriated to carry out this section in a fiscal
year may be used for source water quality protection programs described in subsection (a)(2)
of this section.
(c) Condition
As a condition to receiving assistance under
this section, a State shall ensure that such assistance is carried out in the most cost-effective
manner, as determined by the State.
(d) Authorization of appropriations
(1) Unconditional authorization
There are authorized to be appropriated to
carry out this section $25,000,000 for each of
fiscal years 1997 through 2003. Such sums shall
remain available until expended.
(2) Conditional authorization
In addition to amounts authorized under
paragraph (1), there are authorized to be appropriated to carry out this section $25,000,000
for each of fiscal years 1997 through 2003, provided that such authorization shall be in effect
for a fiscal year only if at least 75 percent of
the total amount of funds authorized to be appropriated for such fiscal year by section
300j–12(m) of this title are appropriated.
(e) Acquisition of lands
Assistance provided with funds made available
under this section may be used for the acquisition of lands and other interests in lands; however, nothing in this section authorizes the acquisition of lands or other interests in lands
from other than willing sellers.
(f) Federal share
The Federal share of the cost of activities for
which grants are made under this section shall
be 50 percent.
(g) Definitions
In this section, the following definitions
apply:
(1) State
The term ‘‘State’’ means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American

§ 300j–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Samoa, and the Commonwealth of the Northern Mariana Islands.
(2) Water supply system
The term ‘‘water supply system’’ means a
system for the provision to the public of piped
water for human consumption if such system
has at least 15 service connections or regularly
serves at least 25 individuals and a draw and
fill system for the provision to the public of
water for human consumption. Such term does
not include a system owned by a Federal agency. Such term includes (A) any collection,
treatment, storage, and distribution facilities
under control of the operator of such system
and used primarily in connection with such
system, and (B) any collection or pretreatment facilities not under such control
that are used primarily in connection with
such system.
(Pub. L. 104–182, title IV, § 401, Aug. 6, 1996, 110
Stat. 1690.)
CODIFICATION
Section was enacted as part of the Safe Drinking
Water Act Amendments of 1996, and not as part of the
Public Health Service Act which comprises this chapter.

§ 300j–4. Records and inspections
(a) Provision of information to Administrator;
monitoring program for unregulated contaminants
(1)(A) Every person who is subject to any requirement of this subchapter or who is a grantee, shall establish and maintain such records,
make such reports, conduct such monitoring,
and provide such information as the Administrator may reasonably require by regulation to
assist the Administrator in establishing regulations under this subchapter, in determining
whether such person has acted or is acting in
compliance with this subchapter, in administering any program of financial assistance under
this subchapter, in evaluating the health risks
of unregulated contaminants, or in advising the
public of such risks. In requiring a public water
system to monitor under this subsection, the
Administrator may take into consideration the
system size and the contaminants likely to be
found in the system’s drinking water.
(B) Every person who is subject to a national
primary drinking water regulation under section 300g–1 of this title shall provide such information as the Administrator may reasonably require, after consultation with the State in which
such person is located if such State has primary
enforcement responsibility for public water systems, on a case-by-case basis, to determine
whether such person has acted or is acting in
compliance with this subchapter.
(C) Every person who is subject to a national
primary drinking water regulation under section 300g–1 of this title shall provide such information as the Administrator may reasonably require to assist the Administrator in establishing
regulations under section 300g–1 of this title,
after consultation with States and suppliers of
water. The Administrator may not require under
this subparagraph the installation of treatment
equipment or process changes, the testing of

Page 1020

treatment technology, or the analysis or processing of monitoring samples, except where the
Administrator provides the funding for such activities. Before exercising this authority, the
Administrator shall first seek to obtain the information by voluntary submission.
(D) The Administrator shall not later than 2
years after August 6, 1996, after consultation
with public health experts, representatives of
the general public, and officials of State and
local governments, review the monitoring requirements for not fewer than 12 contaminants
identified by the Administrator, and promulgate
any necessary modifications.
(2) MONITORING PROGRAM FOR UNREGULATED
CONTAMINANTS.—
Administrator
(A)
ESTABLISHMENT.—The
shall promulgate regulations establishing the
criteria for a monitoring program for unregulated contaminants. The regulations shall require monitoring of drinking water supplied
by public water systems and shall vary the frequency and schedule for monitoring requirements for systems based on the number of persons served by the system, the source of supply, and the contaminants likely to be found,
ensuring that only a representative sample of
systems serving 10,000 persons or fewer are required to monitor.
(B) MONITORING PROGRAM FOR CERTAIN UNREGULATED CONTAMINANTS.—
(i) INITIAL LIST.—Not later than 3 years
after August 6, 1996, and every 5 years thereafter, the Administrator shall issue a list
pursuant to subparagraph (A) of not more
than 30 unregulated contaminants to be
monitored by public water systems and to be
included in the national drinking water occurrence data base maintained pursuant to
subsection (g) of this section.
(ii) GOVERNORS’ PETITION.—The Administrator shall include among the list of contaminants for which monitoring is required
under this paragraph each contaminant recommended in a petition signed by the Governor of each of 7 or more States, unless the
Administrator determines that the action
would prevent the listing of other contaminants of a higher public health concern.
(C) MONITORING PLAN FOR SMALL AND MEDIUM
SYSTEMS.—
(i) IN GENERAL.—Based on the regulations
promulgated by the Administrator, each
State may develop a representative monitoring plan to assess the occurrence of unregulated contaminants in public water systems
that serve a population of 10,000 or fewer in
that State. The plan shall require monitoring for systems representative of different
sizes, types, and geographic locations in the
State.
(ii) GRANTS FOR SMALL SYSTEM COSTS.—
From funds reserved under section 300j–12(o)
of this title or appropriated under subparagraph (H), the Administrator shall pay the
reasonable cost of such testing and laboratory analysis as are necessary to carry out
monitoring under the plan.
(D) MONITORING RESULTS.—Each public water
system that conducts monitoring of unregu-

Page 1021

TITLE 42—THE PUBLIC HEALTH AND WELFARE

lated contaminants pursuant to this paragraph shall provide the results of the monitoring to the primary enforcement authority for
the system.
(E) NOTIFICATION.—Notification of the availability of the results of monitoring programs
required under paragraph (2)(A) shall be given
to the persons served by the system.
(F) WAIVER OF MONITORING REQUIREMENT.—
The Administrator shall waive the requirement for monitoring for a contaminant under
this paragraph in a State, if the State demonstrates that the criteria for listing the contaminant do not apply in that State.
(G) ANALYTICAL METHODS.—The State may
use screening methods approved by the Administrator under subsection (i) of this section
in lieu of monitoring for particular contaminants under this paragraph.
(H) AUTHORIZATION OF APPROPRIATIONS.—
There are authorized to be appropriated to
carry out this paragraph $10,000,000 for each of
the fiscal years 1997 through 2003.
(b) Entry of establishments, facilities, or other
property; inspections; conduct of certain
tests; audit and examination of records;
entry restrictions; prohibition against informing of a proposed entry
(1) Except as provided in paragraph (2), the Administrator, or representatives of the Administrator duly designated by him, upon presenting
appropriate credentials and a written notice to
any supplier of water or other person subject to
(A) a national primary drinking water regulation prescribed under section 300g–1 of this title,
(B) an applicable underground injection control
program, or (C) any requirement to monitor an
unregulated contaminant pursuant to subsection (a) of this section, or person in charge of
any of the property of such supplier or other
person referred to in clause (A), (B), or (C), is authorized to enter any establishment, facility, or
other property of such supplier or other person
in order to determine whether such supplier or
other person has acted or is acting in compliance with this subchapter, including for this
purpose, inspection, at reasonable times, of
records, files, papers, processes, controls, and facilities, or in order to test any feature of a public water system, including its raw water source.
The Administrator or the Comptroller General
(or any representative designated by either)
shall have access for the purpose of audit and
examination to any records, reports, or information of a grantee which are required to be maintained under subsection (a) of this section or
which are pertinent to any financial assistance
under this subchapter.
(2) No entry may be made under the first sentence of paragraph (1) in an establishment, facility, or other property of a supplier of water or
other person subject to a national primary
drinking water regulation if the establishment,
facility, or other property is located in a State
which has primary enforcement responsibility
for public water systems unless, before written
notice of such entry is made, the Administrator
(or his representative) notifies the State agency
charged with responsibility for safe drinking
water of the reasons for such entry. The Admin-

§ 300j–4

istrator shall, upon a showing by the State
agency that such an entry will be detrimental to
the administration of the State’s program of
primary enforcement responsibility, take such
showing into consideration in determining
whether to make such entry. No State agency
which receives notice under this paragraph of an
entry proposed to be made under paragraph (1)
may use the information contained in the notice
to inform the person whose property is proposed
to be entered of the proposed entry; and if a
State agency so uses such information, notice to
the agency under this paragraph is not required
until such time as the Administrator determines
the agency has provided him satisfactory assurances that it will no longer so use information
contained in a notice under this paragraph.
(c) Penalty
Whoever fails or refuses to comply with any
requirement of subsection (a) of this section or
to allow the Administrator, the Comptroller
General, or representatives of either, to enter
and conduct any audit or inspection authorized
by subsection (b) of this section shall be subject
to a civil penalty of not to exceed $25,000.
(d) Confidential information; trade secrets and
secret processes; information disclosure; ‘‘information required under this section’’ defined
(1) Subject to paragraph (2), upon a showing
satisfactory to the Administrator by any person
that any information required under this section
from such person, if made public, would divulge
trade secrets or secret processes of such person,
the Administrator shall consider such information confidential in accordance with the purposes of section 1905 of title 18. If the applicant
fails to make a showing satisfactory to the Administrator, the Administrator shall give such
applicant thirty days’ notice before releasing
the information to which the application relates
(unless the public health or safety requires an
earlier release of such information).
(2) Any information required under this section (A) may be disclosed to other officers, employees, or authorized representatives of the
United States concerned with carrying out this
subchapter or to committees of the Congress, or
when relevant in any proceeding under this subchapter, and (B) shall be disclosed to the extent
it deals with the level of contaminants in drinking water. For purposes of this subsection the
term ‘‘information required under this section’’
means any papers, books, documents, or information, or any particular part thereof, reported
to or otherwise obtained by the Administrator
under this section.
(e) ‘‘Grantee’’ and ‘‘person’’ defined
For purposes of this section, (1) the term
‘‘grantee’’ means any person who applies for or
receives financial assistance, by grant, contract,
or loan guarantee under this subchapter, and (2)
the term ‘‘person’’ includes a Federal agency.
(f) Information regarding drinking water coolers
The Administrator may utilize the authorities
of this section for purposes of part F of this subchapter. Any person who manufactures, imports,
sells, or distributes drinking water coolers in

§ 300j–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

interstate commerce shall be treated as a supplier of water for purposes of applying the provisions of this section in the case of persons subject to part F of this subchapter.
(g) Occurrence data base
(1) In general
Not later than 3 years after August 6, 1996,
the Administrator shall assemble and maintain a national drinking water contaminant
occurrence data base, using information on
the occurrence of both regulated and unregulated contaminants in public water systems
obtained under subsection (a)(1)(A) of this section or subsection (a)(2) of this section and reliable information from other public and private sources.
(2) Public input
In establishing the occurrence data base, the
Administrator shall solicit recommendations
from the Science Advisory Board, the States,
and other interested parties concerning the
development and maintenance of a national
drinking water contaminant occurrence data
base, including such issues as the structure
and design of the data base, data input parameters and requirements, and the use and interpretation of data.
(3) Use
The data shall be used by the Administrator
in making determinations under section
300g–1(b)(1) of this title with respect to the occurrence of a contaminant in drinking water
at a level of public health concern.
(4) Public recommendations
The Administrator shall periodically solicit
recommendations from the appropriate officials of the National Academy of Sciences and
the States, and any person may submit recommendations to the Administrator, with respect
to contaminants that should be included in
the national drinking water contaminant occurrence data base, including recommendations with respect to additional unregulated
contaminants that should be listed under subsection (a)(2) of this section. Any recommendation submitted under this clause shall
be accompanied by reasonable documentation
that—
(A) the contaminant occurs or is likely to
occur in drinking water; and
(B) the contaminant poses a risk to public
health.
(5) Public availability
The information from the data base shall be
available to the public in readily accessible
form.
(6) Regulated contaminants
With respect to each contaminant for which
a national primary drinking water regulation
has been established, the data base shall include information on the detection of the contaminant at a quantifiable level in public
water systems (including detection of the contaminant at levels not constituting a violation of the maximum contaminant level for
the contaminant).

Page 1022

(7) Unregulated contaminants
With respect to contaminants for which a
national primary drinking water regulation
has not been established, the data base shall
include—
(A) monitoring information collected by
public water systems that serve a population
of more than 10,000, as required by the Administrator under subsection (a) of this section;
(B) monitoring information collected from
a representative sampling of public water
systems that serve a population of 10,000 or
fewer; and
(C) other reliable and appropriate monitoring information on the occurrence of the
contaminants in public water systems that
is available to the Administrator.
(h) Availability of information on small system
technologies
For purposes of sections 300g–1(b)(4)(E) and
300g–4(e) of this title (relating to small system
variance program), the Administrator may request information on the characteristics of commercially available treatment systems and technologies, including the effectiveness and performance of the systems and technologies under
various operating conditions. The Administrator
may specify the form, content, and submission
date of information to be submitted by manufacturers, States, and other interested persons for
the purpose of considering the systems and technologies in the development of regulations or
guidance under sections 300g–1(b)(4)(E) and
300g–4(e) of this title.
(i) Screening methods
The Administrator shall review new analytical
methods to screen for regulated contaminants
and may approve such methods as are more accurate or cost-effective than established reference methods for use in compliance monitoring.
(July 1, 1944, ch. 373, title XIV, § 1445, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1686;
amended Pub. L. 95–190, § 12(c), (d), Nov. 16, 1977,
91 Stat. 1398; Pub. L. 99–339, title I, § 106, title III,
§ 301(h), June 19, 1986, 100 Stat. 650, 665; Pub. L.
100–572, § 5, Oct. 31, 1988, 102 Stat. 2889; Pub. L.
104–182, title I, §§ 111(b), 125(a), (c), (d), 126, Aug.
6, 1996, 110 Stat. 1633, 1653, 1656–1658.)
AMENDMENTS
1996—Subsec. (a)(1). Pub. L. 104–182, § 125(a), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘Every person who is a supplier of water, who
is or may be otherwise subject to a primary drinking
water regulation prescribed under section 300g–1 of this
title or to an applicable underground injection control
program (as defined in section 300h–1(c) of this title),
who is or may be subject to the permit requirement of
section 300h–3 of this title, or to an order issued under
section 300j of this title, or who is a grantee, shall establish and maintain such records, make such reports,
conduct such monitoring, and provide such information
as the Administrator may reasonably require by regulation to assist him in establishing regulations under
this subchapter, in determining whether such person
has acted or is acting in compliance with this subchapter in administering any program of financial assistance under this subchapter, in evaluating the
health risks of unregulated contaminants, or in advis-

Page 1023

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing the public of such risks. In requiring a public water
system to monitor under this subsection, the Administrator may take into consideration the system size and
the contaminants likely to be found in the system’s
drinking water.’’
Subsec. (a)(2) to (8). Pub. L. 104–182, § 125(c), added
heading and text of par. (2) and struck out former pars.
(2) to (8) which directed Administrator, not later than
18 months after June 19, 1986, to promulgate regulations requiring every public water system to conduct a
monitoring program for unregulated contaminants,
specified contents of regulations, provided for reporting
and notification of availability of results of monitoring, waiver of monitoring requirements, and compliance by small systems, and authorized appropriations
for fiscal year ending Sept. 30, 1987.
Subsec. (g). Pub. L. 104–182, § 126, added subsec. (g).
Subsec. (h). Pub. L. 104–182, § 111(b), added subsec. (h).
Subsec. (i). Pub. L. 104–182, § 125(d), added subsec. (i).
1988—Subsec. (f). Pub. L. 100–572 added subsec. (f).
1986—Subsec. (a)(1). Pub. L. 99–339, § 106(a), (b), designated existing provisions as par. (1) and inserted provisions permitting Administrator to consider size of
system and contaminants likely to be found.
Subsec. (a)(2) to (7). Pub. L. 99–339, § 106(b), added
pars. (2) to (7).
Subsec. (a)(8). Pub. L. 99–339, § 301(h), added par. (8).
Subsec. (c). Pub. L. 99–339, § 106(c), substituted ‘‘shall
be subject to a civil penalty of not to exceed $25,000’’
for ‘‘may be fined not more than $5,000’’.
1977—Subsec. (a). Pub. L. 95–190, § 12(c), inserted provisions relating to evaluating and advising of health
risks of unregulated contaminants.
Subsec. (b)(1). Pub. L. 95–190, § 12(d), designated existing provisions as cls. (A) and (B) and added cl. (C) and
reference to such cls. (A) to (C).

§ 300j–5. National Drinking Water Advisory Council
(a) Establishment; membership; representation
of interests; term of office, vacancies; reappointment
There is established a National Drinking
Water Advisory Council which shall consist of
fifteen members appointed by the Administrator
after consultation with the Secretary. Five
members shall be appointed from the general
public; five members shall be appointed from appropriate State and local agencies concerned
with water hygiene and public water supply; and
five members shall be appointed from representatives of private organizations or groups demonstrating an active interest in the field of
water hygiene and public water supply, of which
two such members shall be associated with
small, rural public water systems. Each member
of the Council shall hold office for a term of
three years, except that—
(1) any member appointed to fill a vacancy
occurring prior to the expiration of the term
for which his predecessor was appointed shall
be appointed for the remainder of such term;
and
(2) the terms of the members first taking office shall expire as follows: Five shall expire
three years after December 16, 1974, five shall
expire two years after such date, and five shall
expire one year after such date, as designated
by the Administrator at the time of appointment.
The members of the Council shall be eligible for
reappointment.
(b) Functions
The Council shall advise, consult with, and
make recommendations to, the Administrator

§ 300j–6

on matters relating to activities, functions, and
policies of the Agency under this subchapter.
(c) Compensation and allowances; travel expenses
Members of the Council appointed under this
section shall, while attending meetings or conferences of the Council or otherwise engaged in
business of the Council, receive compensation
and allowances at a rate to be fixed by the Administrator, but not exceeding the daily equivalent of the annual rate of basic pay in effect for
grade GS–18 of the General Schedule for each
day (including traveltime) during which they
are engaged in the actual performance of duties
vested in the Council. While away from their
homes or regular places of business in the performance of services for the Council, members of
the Council shall be allowed travel expenses, including per diem in lieu of subsistence, in the
same manner as persons employed intermittently in the Government service are allowed
expenses under section 5703(b) 1 of title 5.
(d) Advisory committee termination provision inapplicable
Section 14(a) of the Federal Advisory Committee Act (relating to termination) shall not apply
to the Council.
(July 1, 1944, ch. 373, title XIV, § 1446, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1688;
amended Pub. L. 104–182, title I, § 127, Aug. 6,
1996, 110 Stat. 1659.)
REFERENCES IN TEXT
Section 5703 of title 5, referred to in subsec. (c), was
amended generally by Pub. L. 94–22, § 4, May 19, 1975, 89
Stat. 85, and, as so amended, does not contain a subsec.
(b).
Section 14(a) of the Federal Advisory Committee Act,
referred to in subsec. (d), is section 14(a) of Pub. L.
92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.
AMENDMENTS
1996—Subsec. (a). Pub. L. 104–182 inserted ‘‘, of which
two such members shall be associated with small, rural
public water systems’’ before period at end of second
sentence.
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 300j–6. Federal agencies
(a) In general
Each department, agency, and instrumentality of the executive, legislative, and judicial
branches of the Federal Government—
1 See

References in Text note below.

§ 300j–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) owning or operating any facility in a
wellhead protection area;
(2) engaged in any activity at such facility
resulting, or which may result, in the contamination of water supplies in any such area;
(3) owning or operating any public water system; or
(4) engaged in any activity resulting, or
which may result in, underground injection
which endangers drinking water (within the
meaning of section 300h(d)(2) of this title),
shall be subject to, and comply with, all Federal, State, interstate, and local requirements,
both substantive and procedural (including any
requirement for permits or reporting or any provisions for injunctive relief and such sanctions
as may be imposed by a court to enforce such relief), respecting the protection of such wellhead
areas, respecting such public water systems, and
respecting any underground injection in the
same manner and to the same extent as any person is subject to such requirements, including
the payment of reasonable service charges. The
Federal, State, interstate, and local substantive
and procedural requirements referred to in this
subsection include, but are not limited to, all
administrative orders and all civil and administrative penalties and fines, regardless of whether such penalties or fines are punitive or coercive in nature or are imposed for isolated, intermittent, or continuing violations. The United
States hereby expressly waives any immunity
otherwise applicable to the United States with
respect to any such substantive or procedural
requirement (including, but not limited to, any
injunctive relief, administrative order or civil or
administrative penalty or fine referred to in the
preceding sentence, or reasonable service
charge). The reasonable service charges referred
to in this subsection include, but are not limited
to, fees or charges assessed in connection with
the processing and issuance of permits, renewal
of permits, amendments to permits, review of
plans, studies, and other documents, and inspection and monitoring of facilities, as well as any
other nondiscriminatory charges that are assessed in connection with a Federal, State,
interstate, or local regulatory program respecting the protection of wellhead areas or public
water systems or respecting any underground
injection. Neither the United States, nor any
agent, employee, or officer thereof, shall be immune or exempt from any process or sanction of
any State or Federal Court 1 with respect to the
enforcement of any such injunctive relief. No
agent, employee, or officer of the United States
shall be personally liable for any civil penalty
under any Federal, State, interstate, or local
law concerning the protection of wellhead areas
or public water systems or concerning underground injection with respect to any act or
omission within the scope of the official duties
of the agent, employee, or officer. An agent, employee, or officer of the United States shall be
subject to any criminal sanction (including, but
not limited to, any fine or imprisonment) under
any Federal or State requirement adopted pursuant to this subchapter, but no department,
1 So

in original. Probably should not be capitalized.

Page 1024

agency, or instrumentality of the executive, legislative, or judicial branch of the Federal Government shall be subject to any such sanction.
The President may exempt any facility of any
department, agency, or instrumentality in the
executive branch from compliance with such a
requirement if he determines it to be in the
paramount interest of the United States to do
so. No such exemption shall be granted due to
lack of appropriation unless the President shall
have specifically requested such appropriation
as a part of the budgetary process and the Congress shall have failed to make available such
requested appropriation. Any exemption shall be
for a period not in excess of 1 year, but additional exemptions may be granted for periods
not to exceed 1 year upon the President’s making a new determination. The President shall report each January to the Congress all exemptions from the requirements of this section
granted during the preceding calendar year, together with his reason for granting each such
exemption.
(b) Administrative penalty orders
(1) In general
If the Administrator finds that a Federal
agency has violated an applicable requirement
under this subchapter, the Administrator may
issue a penalty order assessing a penalty
against the Federal agency.
(2) Penalties
The Administrator may, after notice to the
agency, assess a civil penalty against the
agency in an amount not to exceed $25,000 per
day per violation.
(3) Procedure
Before an administrative penalty order issued under this subsection becomes final, the
Administrator shall provide the agency an opportunity to confer with the Administrator
and shall provide the agency notice and an opportunity for a hearing on the record in accordance with chapters 5 and 7 of title 5.
(4) Public review
(A) In general
Any interested person may obtain review
of an administrative penalty order issued
under this subsection. The review may be obtained in the United States District Court
for the District of Columbia or in the United
States District Court for the district in
which the violation is alleged to have occurred by the filing of a complaint with the
court within the 30-day period beginning on
the date the penalty order becomes final.
The person filing the complaint shall simultaneously send a copy of the complaint by
certified mail to the Administrator and the
Attorney General.
(B) Record
The Administrator shall promptly file in
the court a certified copy of the record on
which the order was issued.
(C) Standard of review
The court shall not set aside or remand
the order unless the court finds that there is

Page 1025

TITLE 42—THE PUBLIC HEALTH AND WELFARE

not substantial evidence in the record, taken
as a whole, to support the finding of a violation or that the assessment of the penalty
by the Administrator constitutes an abuse of
discretion.
(D) Prohibition on additional penalties
The court may not impose an additional
civil penalty for a violation that is subject
to the order unless the court finds that the
assessment constitutes an abuse of discretion by the Administrator.
(c) Limitation on State use of funds collected
from Federal Government
Unless a State law in effect on August 6, 1996,
or a State constitution requires the funds to be
used in a different manner, all funds collected
by a State from the Federal Government from
penalties and fines imposed for violation of any
substantive or procedural requirement referred
to in subsection (a) of this section shall be used
by the State only for projects designed to improve or protect the environment or to defray
the costs of environmental protection or enforcement.
(d) Indian rights and sovereignty as unaffected;
‘‘Federal agency’’ defined
(1) Nothing in the Safe Drinking Water
Amendments of 1977 shall be construed to alter
or affect the status of American Indian lands or
water rights nor to waive any sovereignty over
Indian lands guaranteed by treaty or statute.
(2) For the purposes of this chapter, the term
‘‘Federal agency’’ shall not be construed to refer
to or include any American Indian tribe, nor to
the Secretary of the Interior in his capacity as
trustee of Indian lands.
(e) Washington Aqueduct
The Secretary of the Army shall not pass the
cost of any penalty assessed under this subchapter on to any customer, user, or other purchaser of drinking water from the Washington
Aqueduct system, including finished water from
the Dalecarlia or McMillan treatment plant.
(July 1, 1944, ch. 373, title XIV, § 1447, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1688;
amended Pub. L. 95–190, § 8(a), (d), Nov. 16, 1977,
91 Stat. 1396, 1397; Pub. L. 104–182, title I, § 129(a),
(c), Aug. 6, 1996, 110 Stat. 1660, 1662.)
REFERENCES IN TEXT
The Safe Drinking Water Amendments of 1977, referred to in subsec. (d)(1), is Pub. L. 95–190, Nov. 16, 1977,
91 Stat. 1393. For complete classification of this Act to
the Code, see Short Title of 1977 Amendment note set
out under section 201 of this title and Tables.
AMENDMENTS
1996—Subsecs. (a) to (d). Pub. L. 104–182, § 129(a), added
subsecs. (a) to (c), redesignated former subsec. (c) as
(d), and struck out former subsecs. (a) and (b) which related to compliance by Federal agencies with Federal,
State, and local requirements respecting provision of
safe drinking water and respecting underground injection programs, liability for civil penalties, and waiver
of compliance requirements when necessary in interest
of national security.
Subsec. (e). Pub. L. 104–182, § 129(c), added subsec. (e).
1977—Subsec. (a). Pub. L. 95–190, § 8(a), substituted
provisions relating to compliance by Federal agencies
having jurisdiction over federally owned or maintained

§ 300j–7

public water systems, or engaged in underground injection activities with Federal, State, and local requirements, etc., for provisions relating to compliance by
Federal agencies having jurisdiction over federally
owned or maintained public water systems with national primary drinking water regulations.
Subsec. (c). Pub. L. 95–190, § 8(d), added subsec. (c).

§ 300j–7. Judicial review
(a) Courts of appeals; petition for review: actions
respecting regulations; filing period; grounds
arising after expiration of filing period; exclusiveness of remedy
A petition for review of—
(1) actions pertaining to the establishment
of national primary drinking water regulations (including maximum contaminant level
goals) may be filed only in the United States
Court of Appeals for the District of Columbia
circuit; and
(2) any other final action of the Administrator under this chapter may be filed in the
circuit in which the petitioner resides or
transacts business which is directly affected
by the action.
Any such petition shall be filed within the 45day period beginning on the date of the promulgation of the regulation or any other final Agency action with respect to which review is sought
or on the date of the determination with respect
to which review is sought, and may be filed after
the expiration of such 45-day period if the petition is based solely on grounds arising after the
expiration of such period. Action of the Administrator with respect to which review could have
been obtained under this subsection shall not be
subject to judicial review in any civil or criminal proceeding for enforcement or in any civil
action to enjoin enforcement. In any petition
concerning the assessment of a civil penalty
pursuant to section 300g–3(g)(3)(B) of this title,
the petitioner shall simultaneously send a copy
of the complaint by certified mail to the Administrator and the Attorney General. The court
shall set aside and remand the penalty order if
the court finds that there is not substantial evidence in the record to support the finding of a
violation or that the assessment of the penalty
by the Administrator constitutes an abuse of
discretion.
(b) District courts; petition for review: actions
respecting variances or exemptions; filing
period; grounds arising after expiration of
filing period; exclusiveness of remedy
The United States district courts shall have
jurisdiction of actions brought to review (1) the
granting of, or the refusing to grant, a variance
or exemption under section 300g–4 or 300g–5 of
this title or (2) the requirements of any schedule
prescribed for a variance or exemption under
such section or the failure to prescribe such a
schedule. Such an action may only be brought
upon a petition for review filed with the court
within the 45-day period beginning on the date
the action sought to be reviewed is taken or, in
the case of a petition to review the refusal to
grant a variance or exemption or the failure to
prescribe a schedule, within the 45-day period
beginning on the date action is required to be
taken on the variance, exemption, or schedule,

§ 300j–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE

as the case may be. A petition for such review
may be filed after the expiration of such period
if the petition is based solely on grounds arising
after the expiration of such period. Action with
respect to which review could have been obtained under this subsection shall not be subject
to judicial review in any civil or criminal proceeding for enforcement or in any civil action to
enjoin enforcement.
(c) Judicial order for additional evidence before
Administrator; modified or new findings; recommendation for modification or setting
aside of original determination
In any judicial proceeding in which review is
sought of a determination under this subchapter
required to be made on the record after notice
and opportunity for hearing, if any party applies
to the court for leave to adduce additional evidence and shows to the satisfaction of the court
that such additional evidence is material and
that there were reasonable grounds for the failure to adduce such evidence in the proceeding
before the Administrator, the court may order
such additional evidence (and evidence in rebuttal thereof) to be taken before the Administrator, in such manner and upon such term and
conditions as the court may deem proper. The
Administrator may modify his findings as to the
facts, or make new findings, by reason of the additional evidence so taken, and he shall file such
modified or new findings, and his recommendation, if any, for the modification or setting aside
of his original determination, with the return of
such additional evidence.
(July 1, 1944, ch. 373, title XIV, § 1448, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1689;
amended Pub. L. 99–339, title III, § 303, June 19,
1986, 100 Stat. 667; Pub. L. 104–182, title I, § 113(c),
Aug. 6, 1996, 110 Stat. 1636.)
AMENDMENTS
1996—Subsec. (a). Pub. L. 104–182, § 113(c)(2), (3), in
concluding provisions, substituted ‘‘or any other final
Agency action’’ for ‘‘or issuance of the order’’ and inserted at end ‘‘In any petition concerning the assessment of a civil penalty pursuant to section
300g–3(g)(3)(B) of this title, the petitioner shall simultaneously send a copy of the complaint by certified mail
to the Administrator and the Attorney General. The
court shall set aside and remand the penalty order if
the court finds that there is not substantial evidence in
the record to support the finding of a violation or that
the assessment of the penalty by the Administrator
constitutes an abuse of discretion.’’
Subsec. (a)(2). Pub. L. 104–182, § 113(c)(1), substituted
‘‘any other final action’’ for ‘‘any other action’’.
1986—Subsec. (a)(1). Pub. L. 99–339, § 303(1), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘action of the Administrator in promulgating
any national primary drinking water regulation under
section 300g–1 of this title, any regulation under section 300g–2(b)(1) of this title, any regulation under section 300g–3(c) of this title, any regulation for State underground injection control programs under section
300h of this title, or any general regulation for the administration of this subchapter may be filed only in the
United States Court of Appeals for the District of Columbia Circuit; and’’.
Subsec. (a)(2). Pub. L. 99–339, § 303(2), amended par. (2)
generally. Prior to amendment, par. (2) read as follows:
‘‘action of the Administrator in promulgating any
other regulation under this subchapter, issuing any
order under this subchapter, or making any determina-

Page 1026

tion under this subchapter may be filed only in the
United States court of appeals for the appropriate circuit.’’

§ 300j–8. Citizen’s civil action
(a) Persons subject to civil action; jurisdiction of
enforcement proceedings
Except as provided in subsection (b) of this
section, any person may commence a civil action on his own behalf—
(1) against any person (including (A) the
United States, and (B) any other governmental instrumentality or agency to the extent permitted by the eleventh amendment to
the Constitution) who is alleged to be in violation of any requirement prescribed by or under
this subchapter;
(2) against the Administrator where there is
alleged a failure of the Administrator to perform any act or duty under this subchapter
which is not discretionary with the Administrator; or
(3) for the collection of a penalty by the
United States Government (and associated
costs and interest) against any Federal agency
that fails, by the date that is 18 months after
the effective date of a final order to pay a penalty assessed by the Administrator under section 300h–8(b) 1 of this title, to pay the penalty.
No action may be brought under paragraph (1)
against a public water system for a violation of
a requirement prescribed by or under this subchapter which occurred within the 27-month period beginning on the first day of the month in
which this subchapter is enacted. The United
States district courts shall have jurisdiction,
without regard to the amount in controversy or
the citizenship of the parties, to enforce in an
action brought under this subsection any requirement prescribed by or under this subchapter or to order the Administrator to perform an act or duty described in paragraph (2),
as the case may be.
(b) Conditions for commencement of civil action;
notice
No civil action may be commenced—
(1) under subsection (a)(1) of this section respecting violation of a requirement prescribed
by or under this subchapter—
(A) prior to sixty days after the plaintiff
has given notice of such violation (i) to the
Administrator, (ii) to any alleged violator of
such requirement and (iii) to the State in
which the violation occurs, or
(B) if the Administrator, the Attorney
General, or the State has commenced and is
diligently prosecuting a civil action in a
court of the United States to require compliance with such requirement, but in any such
action in a court of the United States any
person may intervene as a matter of right;
or
(2) under subsection (a)(2) of this section
prior to sixty days after the plaintiff has given
notice of such action to the Administrator; or
(3) under subsection (a)(3) of this section
prior to 60 days after the plaintiff has given
1 So

in original. Probably should be section ‘‘300j–6(b)’’.

Page 1027

TITLE 42—THE PUBLIC HEALTH AND WELFARE

notice of such action to the Attorney General
and to the Federal agency.
Notice required by this subsection shall be given
in such manner as the Administrator shall prescribe by regulation. No person may commence
a civil action under subsection (a) of this section
to require a State to prescribe a schedule under
section 300g–4 or 300g–5 of this title for a variance or exemption, unless such person shows to
the satisfaction of the court that the State has
in a substantial number of cases failed to prescribe such schedules.
(c) Intervention of right
In any action under this section, the Administrator or the Attorney General, if not a party,
may intervene as a matter of right.
(d) Costs; attorney fees; expert witness fees; filing of bond
The court, in issuing any final order in any action brought under subsection (a) of this section,
may award costs of litigation (including reasonable attorney and expert witness fees) to any
party whenever the court determines such an
award is appropriate. The court may, if a temporary restraining order or preliminary injunction is sought, require the filing of a bond or
equivalent security in accordance with the Federal Rules of Civil Procedure.
(e) Availability of other relief
Nothing in this section shall restrict any right
which any person (or class of persons) may have
under any statute or common law to seek enforcement of any requirement prescribed by or
under this subchapter or to seek any other relief. Nothing in this section or in any other law
of the United States shall be construed to prohibit, exclude, or restrict any State or local government from—
(1) bringing any action or obtaining any
remedy or sanction in any State or local
court, or
(2) bringing any administrative action or obtaining any administrative remedy or sanction,
against any agency of the United States under
State or local law to enforce any requirement
respecting the provision of safe drinking water
or respecting any underground injection control
program. Nothing in this section shall be construed to authorize judicial review of regulations or orders of the Administrator under this
subchapter, except as provided in section 300j–7
of this title. For provisions providing for application of certain requirements to such agencies
in the same manner as to nongovernmental entities, see section 300j–6 of this title.
(July 1, 1944, ch. 373, title XIV, § 1449, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1690;
amended Pub. L. 95–190, § 8(c), Nov. 16, 1977, 91
Stat. 1397; Pub. L. 104–182, title I, § 129(b), Aug. 6,
1996, 110 Stat. 1662.)
REFERENCES IN TEXT
The Federal Rules of Civil Procedure, referred to in
subsec. (d), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.
AMENDMENTS
1996—Subsec. (a)(3). Pub. L. 104–182, § 129(b)(1), added
par. (3).

§ 300j–9

Subsec. (b)(3). Pub. L. 104–182, § 129(b)(2), added par.
(3).
1977—Subsec. (e). Pub. L. 95–190 inserted provisions
relating to suits by State or local governments for enforcement of safe drinking water, etc., requirements.

§ 300j–9. General provisions
(a) Regulations; delegation of functions
(1) The Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this
subchapter.
(2) The Administrator may delegate any of his
functions under this subchapter (other than prescribing regulations) to any officer or employee
of the Agency.
(b) Utilization of officers and employees of Federal agencies
The Administrator, with the consent of the
head of any other agency of the United States,
may utilize such officers and employees of such
agency as he deems necessary to assist him in
carrying out the purposes of this subchapter.
(c) Assignment of Agency personnel to State or
interstate agencies
Upon the request of a State or interstate agency, the Administrator may assign personnel of
the Agency to such State or interstate agency
for the purposes of carrying out the provisions
of this subchapter.
(d) Payments of grants; adjustments; advances;
reimbursement; installments; conditions; eligibility for grants; ‘‘nonprofit agency or institution’’ defined
(1) The Administrator may make payments of
grants under this subchapter (after necessary
adjustment on account of previously made underpayments or overpayments) in advance or by
way of reimbursement, and in such installments
and on such conditions as he may determine.
(2) Financial assistance may be made available in the form of grants only to individuals
and nonprofit agencies or institutions. For purposes of this paragraph, the term ‘‘nonprofit
agency or institution’’ means an agency or institution no part of the net earnings of which
inure, or may lawfully inure, to the benefit of
any private shareholder or individual.
(e) Labor standards
The Administrator shall take such action as
may be necessary to assure compliance with
provisions of sections 3141–3144, 3146, and 3147 of
title 40. The Secretary of Labor shall have, with
respect to the labor standards specified in this
subsection, the authority and functions set forth
in Reorganization Plan Numbered 14 of 1950 (15
F.R. 3176; 64 Stat. 1267) and section 3145 of title
40.
(f) Appearance and representation of Administrator through Attorney General or attorney
appointees
The Administrator shall request the Attorney
General to appear and represent him in any civil
action instituted under this subchapter to which
the Administrator is a party. Unless, within a
reasonable time, the Attorney General notifies
the Administrator that he will appear in such
action, attorneys appointed by the Administrator shall appear and represent him.

§ 300j–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(g) Authority of Administrator under other provisions unaffected
The provisions of this subchapter shall not be
construed as affecting any authority of the Administrator under part G of subchapter II of this
chapter.
(h) Reports to Congressional committees; review
by Office of Management and Budget: submittal of comments to Congressional committees
Not later than April 1 of each year, the Administrator shall submit to the Committee on
Commerce, Science, and Transportation of the
Senate and the Committee on Energy and Commerce of the House of Representatives a report
respecting the activities of the Agency under
this subchapter and containing such recommendations for legislation as he considers necessary. The report of the Administrator under
this subsection which is due not later than April
1, 1975, and each subsequent report of the Administrator under this subsection shall include
a statement on the actual and anticipated cost
to public water systems in each State of compliance with the requirements of this subchapter.
The Office of Management and Budget may review any report required by this subsection before its submission to such committees of Congress, but the Office may not revise any such report, require any revision in any such report, or
delay its submission beyond the day prescribed
for its submission, and may submit to such committees of Congress its comments respecting
any such report.
(i) Discrimination prohibition; filing of complaint; investigation; orders of Secretary; notice and hearing; settlements; attorneys’ fees;
judicial review; filing of petition; procedural
requirements; stay of orders; exclusiveness of
remedy; civil actions for enforcement of orders; appropriate relief; mandamus proceedings; prohibition inapplicable to undirected
but deliberate violations
(1) No employer may discharge any employee
or otherwise discriminate against any employee
with respect to his compensation, terms, conditions, or privileges of employment because the
employee (or any person acting pursuant to a request of the employee) has—
(A) commenced, caused to be commenced, or
is about to commence or cause to be commenced a proceeding under this subchapter or
a proceeding for the administration or enforcement of drinking water regulations or underground injection control programs of a
State,
(B) testified or is about to testify in any
such proceeding, or
(C) assisted or participated or is about to assist or participate in any manner in such a
proceeding or in any other action to carry out
the purposes of this subchapter.
(2)(A) Any employee who believes that he has
been discharged or otherwise discriminated
against by any person in violation of paragraph
(1) may, within 30 days after such violation occurs, file (or have any person file on his behalf)
a complaint with the Secretary of Labor (hereinafter in this subsection referred to as the

Page 1028

‘‘Secretary’’) alleging such discharge or discrimination. Upon receipt of such a complaint,
the Secretary shall notify the person named in
the complaint of the filing of the complaint.
(B)(i) Upon receipt of a complaint filed under
subparagraph (A), the Secretary shall conduct
an investigation of the violation alleged in the
complaint. Within 30 days of the receipt of such
complaint, the Secretary shall complete such investigation and shall notify in writing the complainant (and any person acting in his behalf)
and the person alleged to have committed such
violation of the results of the investigation conducted pursuant to this subparagraph. Within 90
days of the receipt of such complaint the Secretary shall, unless the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person alleged to have committed
such violation, issue an order either providing
the relief prescribed by clause (ii) or denying the
complaint. An order of the Secretary shall be
made on the record after notice and opportunity
for agency hearing. The Secretary may not
enter into a settlement terminating a proceeding on a complaint without the participation
and consent of the complainant.
(ii) If in response to a complaint filed under
subparagraph (A) the Secretary determines that
a violation of paragraph (1) has occurred, the
Secretary shall order (I) the person who committed such violation to take affirmative action
to abate the violation, (II) such person to reinstate the complainant to his former position together with the compensation (including back
pay), terms, conditions, and privileges of his employment, (III) compensatory damages, and (IV)
where appropriate, exemplary damages. If such
an order is issued, the Secretary, at the request
of the complainant, shall assess against the person against whom the order is issued a sum
equal to the aggregate amount of all costs and
expenses (including attorneys’ fees) reasonably
incurred, as determined by the Secretary, by the
complainant for, or in connection with, the
bringing of the complaint upon which the order
was issued.
(3)(A) Any person adversely affected or aggrieved by an order issued under paragraph (2)
may obtain review of the order in the United
States Court of Appeals for the circuit in which
the violation, with respect to which the order
was issued, allegedly occurred. The petition for
review must be filed within sixty days from the
issuance of the Secretary’s order. Review shall
conform to chapter 7 of title 5. The commencement of proceedings under this subparagraph
shall not, unless ordered by the court, operate as
a stay of the Secretary’s order.
(B) An order of the Secretary with respect to
which review could have been obtained under
subparagraph (A) shall not be subject to judicial
review in any criminal or other civil proceeding.
(4) Whenever a person has failed to comply
with an order issued under paragraph (2)(B), the
Secretary shall file a civil action in the United
States District Court for the district in which
the violation was found to occur to enforce such
order. In actions brought under this paragraph,
the district courts shall have jurisdiction to
grant all appropriate relief including, but not

Page 1029

TITLE 42—THE PUBLIC HEALTH AND WELFARE

limited to, injunctive relief, compensatory, and
exemplary damages.
(5) Any nondiscretionary duty imposed by this
section is enforceable in mandamus proceeding
brought under section 1361 of title 28.
(6) Paragraph (1) shall not apply with respect
to any employee who, acting without direction
from his employer (or the employer’s agent), deliberately causes a violation of any requirement
of this subchapter.
(July 1, 1944, ch. 373, title XIV, § 1450, as added
Pub. L. 93–523, § 2(a), Dec. 16, 1974, 88 Stat. 1691;
amended Pub. L. 98–620, title IV, § 402(38), Nov. 8,
1984, 98 Stat. 3360; Pub. L. 103–437, § 15(a)(2), Nov.
2, 1994, 108 Stat. 4591.)
REFERENCES IN TEXT
Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176;
64 Stat. 1267), referred to in subsec. (e), is set out in the
Appendix to Title 5, Government Organization and Employees.
Part G of subchapter II of this chapter, referred to in
subsec. (g), is classified to section 264 of this title.
CODIFICATION
In subsec. (e), ‘‘sections 3141–3144, 3146, and 3147 of
title 40’’ substituted for ‘‘the Act of March 3, 1931
(known as the Davis-Bacon Act; 40 U.S.C. 276a—
276a(5))’’ and ‘‘section 3145 of title 40’’ substituted for
‘‘section 2 of the Act of June 13, 1934 (40 U.S.C. 276c)’’
on authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116
Stat. 1303, the first section of which enacted Title 40,
Public Buildings, Property, and Works.
AMENDMENTS
1994—Subsec. (h). Pub. L. 103–437 substituted ‘‘Committee on Commerce, Science, and Transportation of
the Senate and the Committee on Energy and Commerce of the House’’ for ‘‘Committee on Commerce of
the Senate and the Committee on Interstate and Foreign Commerce of the House’’.
1984—Subsec. (i)(4). Pub. L. 98–620 struck out provision which required civil actions filed under par. (4) to
be heard and decided expeditiously.
CHANGE OF NAME
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98–620 not applicable to cases
pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620,
set out as an Effective Date note under section 1657 of
Title 28, Judiciary and Judicial Procedure.

§ 300j–10. Appointment of scientific, etc., personnel by Administrator of Environmental Protection Agency for implementation of responsibilities; compensation
To the extent that the Administrator of the
Environmental Protection Agency deems such
action necessary to the discharge of his functions under title XIV of the Public Health Service Act [42 U.S.C. 300f et seq.] (relating to safe
drinking water) and under other provisions of

§ 300j–11

law, he may appoint personnel to fill not more
than thirty scientific, engineering, professional,
legal, and administrative positions within the
Environmental Protection Agency without regard to the civil service laws and may fix the
compensation of such personnel not in excess of
the maximum rate payable for GS–18 of the General Schedule under section 5332 of title 5.
(Pub. L. 95–190, § 11(b), Nov. 16, 1977, 91 Stat.
1398.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in text, is
act July 1, 1944, ch. 373, 58 Stat. 682, as amended. Title
XIV of the Public Health Service Act is classified generally to this subchapter (§ 300f et seq.). For complete
classification of this Act to the Code, see Short Title
note set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Safe Drinking
Water Amendments of 1977, and not as part of the Public Health Service Act which comprises this chapter.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 300j–11. Indian Tribes
(a) In general
Subject to the provisions of subsection (b) of
this section, the Administrator—
(1) is authorized to treat Indian Tribes as
States under this subchapter,
(2) may delegate to such Tribes primary enforcement responsibility for public water systems and for underground injection control,
and
(3) may provide such Tribes grant and contract assistance to carry out functions provided by this subchapter.
(b) EPA regulations
(1) Specific provisions
The Administrator shall, within 18 months
after June 19, 1986, promulgate final regulations specifying those provisions of this subchapter for which it is appropriate to treat Indian Tribes as States. Such treatment shall be
authorized only if:
(A) the Indian Tribe is recognized by the
Secretary of the Interior and has a governing body carrying out substantial governmental duties and powers;
(B) the functions to be exercised by the Indian Tribe are within the area of the Tribal
Government’s jurisdiction; and
(C) the Indian Tribe is reasonably expected
to be capable, in the Administrator’s judgment, of carrying out the functions to be exercised in a manner consistent with the
terms and purposes of this subchapter and of
all applicable regulations.
(2) Provisions where treatment as State inappropriate
For any provision of this subchapter where
treatment of Indian Tribes as identical to

§ 300j–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

States is inappropriate, administratively infeasible or otherwise inconsistent with the
purposes of this subchapter, the Administrator
may include in the regulations promulgated
under this section, other means for administering such provision in a manner that will
achieve the purpose of the provision. Nothing
in this section shall be construed to allow Indian Tribes to assume or maintain primary enforcement responsibility for public water systems or for underground injection control in a
manner less protective of the health of persons
than such responsibility may be assumed or
maintained by a State. An Indian tribe 1 shall
not be required to exercise criminal enforcement jurisdiction for purposes of complying
with the preceding sentence.
(July 1, 1944, ch. 373, title XIV, § 1451, as added
Pub. L. 99–339, title III, § 302(a), June 19, 1986, 100
Stat. 665; amended Pub. L. 104–182, title V,
§ 501(f)(6), Aug. 6, 1996, 110 Stat. 1692.)
AMENDMENTS
1996—Pub. L. 104–182 made technical amendment to
section catchline and subsec. (a) designation.

§ 300j–12. State revolving loan funds
(a) General authority
(1) Grants to States to establish State loan
funds
(A) In general
The Administrator shall offer to enter into
agreements with eligible States to make
capitalization grants, including letters of
credit, to the States under this subsection to
further the health protection objectives of
this subchapter, promote the efficient use of
fund resources, and for other purposes as are
specified in this subchapter.
(B) Establishment of fund
To be eligible to receive a capitalization
grant under this section, a State shall establish a drinking water treatment revolving
loan fund (referred to in this section as a
‘‘State loan fund’’) and comply with the
other requirements of this section. Each
grant to a State under this section shall be
deposited in the State loan fund established
by the State, except as otherwise provided in
this section and in other provisions of this
subchapter. No funds authorized by other
provisions of this subchapter to be used for
other purposes specified in this subchapter
shall be deposited in any State loan fund.
(C) Extended period
The grant to a State shall be available to
the State for obligation during the fiscal
year for which the funds are authorized and
during the following fiscal year, except that
grants made available from funds provided
prior to fiscal year 1997 shall be available for
obligation during each of the fiscal years
1997 and 1998.
(D) Allotment formula
Except as otherwise provided in this section, funds made available to carry out this
1 So

in original. Probably should be capitalized.

Page 1030

section shall be allotted to States that have
entered into an agreement pursuant to this
section (other than the District of Columbia)
in accordance with—
(i) for each of fiscal years 1995 through
1997, a formula that is the same as the formula used to distribute public water system supervision grant funds under section
300j–2 of this title in fiscal year 1995, except that the minimum proportionate
share established in the formula shall be 1
percent of available funds and the formula
shall be adjusted to include a minimum
proportionate share for the State of Wyoming and the District of Columbia; and
(ii) for fiscal year 1998 and each subsequent fiscal year, a formula that allocates
to each State the proportional share of the
State needs identified in the most recent
survey conducted pursuant to subsection
(h) of this section, except that the minimum proportionate share provided to each
State shall be the same as the minimum
proportionate share provided under clause
(i).
(E) Reallotment
The grants not obligated by the last day of
the period for which the grants are available
shall be reallotted according to the appropriate criteria set forth in subparagraph (D),
except that the Administrator may reserve
and allocate 10 percent of the remaining
amount for financial assistance to Indian
Tribes in addition to the amount allotted
under subsection (i) of this section and none
of the funds reallotted by the Administrator
shall be reallotted to any State that has not
obligated all sums allotted to the State pursuant to this section during the period in
which the sums were available for obligation.
(F) Nonprimacy States
The State allotment for a State not exercising primary enforcement responsibility
for public water systems shall not be deposited in any such fund but shall be allotted by
the Administrator under this subparagraph.
Pursuant to section 300j–2(a)(9)(A) of this
title such sums allotted under this subparagraph shall be reserved as needed by the Administrator to exercise primary enforcement
responsibility under this subchapter in such
State and the remainder shall be reallotted
to States exercising primary enforcement
responsibility for public water systems for
deposit in such funds. Whenever the Administrator makes a final determination pursuant to section 300g–2(b) of this title that the
requirements of section 300g–2(a) of this title
are no longer being met by a State, additional grants for such State under this subchapter shall be immediately terminated by
the Administrator. This subparagraph shall
not apply to any State not exercising primary enforcement responsibility for public
water systems as of August 6, 1996.
(G) Other programs
(i) New system capacity
Beginning in fiscal year 1999, the Administrator shall withhold 20 percent of each

Page 1031

TITLE 42—THE PUBLIC HEALTH AND WELFARE

capitalization grant made pursuant to this
section to a State unless the State has met
the requirements of section 300g–9(a) of
this title (relating to capacity development) and shall withhold 10 percent for fiscal year 2001, 15 percent for fiscal year
2002, and 20 percent for fiscal year 2003 if
the State has not complied with the provisions of section 300g–9(c) of this title (relating to capacity development strategies).
Not more than a total of 20 percent of the
capitalization grants made to a State in
any fiscal year may be withheld under the
preceding provisions of this clause. All
funds withheld by the Administrator pursuant to this clause shall be reallotted by
the Administrator on the basis of the same
ratio as is applicable to funds allotted
under subparagraph (D). None of the funds
reallotted by the Administrator pursuant
to this paragraph shall be allotted to a
State unless the State has met the requirements of section 300g–9 of this title
(relating to capacity development).
(ii) Operator certification
The Administrator shall withhold 20 percent of each capitalization grant made
pursuant to this section unless the State
has met the requirements of 300g–8 1 of this
title (relating to operator certification).
All funds withheld by the Administrator
pursuant to this clause shall be reallotted
by the Administrator on the basis of the
same ratio as applicable to funds allotted
under subparagraph (D). None of the funds
reallotted by the Administrator pursuant
to this paragraph shall be allotted to a
State unless the State has met the requirements of section 300g–8 of this title
(relating to operator certification).
(2) Use of funds
Except as otherwise authorized by this subchapter, amounts deposited in a State loan
fund, including loan repayments and interest
earned on such amounts, shall be used only for
providing loans or loan guarantees, or as a
source of reserve and security for leveraged
loans, the proceeds of which are deposited in a
State loan fund established under paragraph
(1), or other financial assistance authorized
under this section to community water systems and nonprofit noncommunity water systems, other than systems owned by Federal
agencies. Financial assistance under this section may be used by a public water system
only for expenditures (not including monitoring, operation, and maintenance expenditures)
of a type or category which the Administrator
has determined, through guidance, will facilitate compliance with national primary drinking water regulations applicable to the system
under section 300g–1 of this title or otherwise
significantly further the health protection objectives of this subchapter. The funds may
also be used to provide loans to a system referred to in section 300f(4)(B) of this title for
the purpose of providing the treatment described in section 300f(4)(B)(i)(III) of this title.
1 So

in original. Probably should be preceded by ‘‘section’’.

§ 300j–12

The funds shall not be used for the acquisition
of real property or interests therein, unless
the acquisition is integral to a project authorized by this paragraph and the purchase is
from a willing seller. Of the amount credited
to any State loan fund established under this
section in any fiscal year, 15 percent shall be
available solely for providing loan assistance
to public water systems which regularly serve
fewer than 10,000 persons to the extent such
funds can be obligated for eligible projects of
public water systems.
(3) Limitation
(A) In general
Except as provided in subparagraph (B), no
assistance under this section shall be provided to a public water system that—
(i) does not have the technical, managerial, and financial capability to ensure
compliance with the requirements of this
subchapter; or
(ii) is in significant noncompliance with
any requirement of a national primary
drinking water regulation or variance.
(B) Restructuring
A public water system described in subparagraph (A) may receive assistance under
this section if—
(i) the use of the assistance will ensure
compliance; and
(ii) if subparagraph (A)(i) applies to the
system, the owner or operator of the system agrees to undertake feasible and appropriate changes in operations (including
ownership,
management,
accounting,
rates, maintenance, consolidation, alternative water supply, or other procedures)
if the State determines that the measures
are necessary to ensure that the system
has the technical, managerial, and financial capability to comply with the requirements of this subchapter over the long
term.
(C) Review
Prior to providing assistance under this
section to a public water system that is in
significant noncompliance with any requirement of a national primary drinking water
regulation or variance, the State shall conduct a review to determine whether subparagraph (A)(i) applies to the system.
(b) Intended use plans
(1) In general
After providing for public review and comment, each State that has entered into a capitalization agreement pursuant to this section
shall annually prepare a plan that identifies
the intended uses of the amounts available to
the State loan fund of the State.
(2) Contents
An intended use plan shall include—
(A) a list of the projects to be assisted in
the first fiscal year that begins after the
date of the plan, including a description of
the project, the expected terms of financial
assistance, and the size of the community
served;

§ 300j–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the criteria and methods established
for the distribution of funds; and
(C) a description of the financial status of
the State loan fund and the short-term and
long-term goals of the State loan fund.
(3) Use of funds
(A) In general
An intended use plan shall provide, to the
maximum extent practicable, that priority
for the use of funds be given to projects
that—
(i) address the most serious risk to
human health;
(ii) are necessary to ensure compliance
with the requirements of this subchapter
(including requirements for filtration); and
(iii) assist systems most in need on a per
household basis according to State affordability criteria.
(B) List of projects
Each State shall, after notice and opportunity for public comment, publish and periodically update a list of projects in the State
that are eligible for assistance under this
section, including the priority assigned to
each project and, to the extent known, the
expected funding schedule for each project.
(c) Fund management
Each State loan fund under this section shall
be established, maintained, and credited with repayments and interest. The fund corpus shall be
available in perpetuity for providing financial
assistance under this section. To the extent
amounts in the fund are not required for current
obligation or expenditure, such amounts shall be
invested in interest bearing obligations.
(d) Assistance for disadvantaged communities
(1) Loan subsidy
Notwithstanding any other provision of this
section, in any case in which the State makes
a loan pursuant to subsection (a)(2) of this section to a disadvantaged community or to a
community that the State expects to become
a disadvantaged community as the result of a
proposed project, the State may provide additional subsidization (including forgiveness of
principal).
(2) Total amount of subsidies
For each fiscal year, the total amount of
loan subsidies made by a State pursuant to
paragraph (1) may not exceed 30 percent of the
amount of the capitalization grant received by
the State for the year.
(3) ‘‘Disadvantaged community’’ defined
In this subsection, the term ‘‘disadvantaged
community’’ means the service area of a public water system that meets affordability criteria established after public review and comment by the State in which the public water
system is located. The Administrator may
publish information to assist States in establishing affordability criteria.
(e) State contribution
Each agreement under subsection (a) of this
section shall require that the State deposit in
the State loan fund from State moneys an

Page 1032

amount equal to at least 20 percent of the total
amount of the grant to be made to the State on
or before the date on which the grant payment
is made to the State, except that a State shall
not be required to deposit such amount into the
fund prior to the date on which each grant payment is made for fiscal years 1994, 1995, 1996, and
1997 if the State deposits the State contribution
amount into the State loan fund prior to September 30, 1999.
(f) Types of assistance
Except as otherwise limited by State law, the
amounts deposited into a State loan fund under
this section may be used only—
(1) to make loans, on the condition that—
(A) the interest rate for each loan is less
than or equal to the market interest rate,
including an interest free loan;
(B) principal and interest payments on
each loan will commence not later than 1
year after completion of the project for
which the loan was made, and each loan will
be fully amortized not later than 20 years
after the completion of the project, except
that in the case of a disadvantaged community (as defined in subsection (d)(3) of this
section), a State may provide an extended
term for a loan, if the extended term—
(i) terminates not later than the date
that is 30 years after the date of project
completion; and
(ii) does not exceed the expected design
life of the project;
(C) the recipient of each loan will establish
a dedicated source of revenue (or, in the case
of a privately owned system, demonstrate
that there is adequate security) for the repayment of the loan; and
(D) the State loan fund will be credited
with all payments of principal and interest
on each loan;
(2) to buy or refinance the debt obligation of
a municipality or an intermunicipal or interstate agency within the State at an interest
rate that is less than or equal to the market
interest rate in any case in which a debt obligation is incurred after July 1, 1993;
(3) to guarantee, or purchase insurance for, a
local obligation (all of the proceeds of which
finance a project eligible for assistance under
this section) if the guarantee or purchase
would improve credit market access or reduce
the interest rate applicable to the obligation;
(4) as a source of revenue or security for the
payment of principal and interest on revenue
or general obligation bonds issued by the
State if the proceeds of the sale of the bonds
will be deposited into the State loan fund; and
(5) to earn interest on the amounts deposited
into the State loan fund.
(g) Administration of State loan funds
(1) Combined financial administration
Notwithstanding subsection (c) of this section, a State may (as a convenience and to
avoid unnecessary administrative costs) combine, in accordance with State law, the financial administration of a State loan fund established under this section with the financial ad-

Page 1033

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ministration of any other revolving fund established by the State if otherwise not prohibited by the law under which the State loan
fund was established and if the Administrator
determines that—
(A) the grants under this section, together
with loan repayments and interest, will be
separately accounted for and used solely for
the purposes specified in subsection (a) of
this section; and
(B) the authority to establish assistance
priorities and carry out oversight and related activities (other than financial administration) with respect to assistance remains
with the State agency having primary responsibility for administration of the State
program under section 300g–2 of this title,
after consultation with other appropriate
State agencies (as determined by the State):
Provided, That in nonprimacy States eligible
to receive assistance under this section, the
Governor shall determine which State agency will have authority to establish priorities
for financial assistance from the State loan
fund.
(2) Cost of administering fund
Each State may annually use up to 4 percent
of the funds allotted to the State under this
section to cover the reasonable costs of administration of the programs under this section,
including the recovery of reasonable costs expended to establish a State loan fund which
are incurred after August 6, 1996, and to provide technical assistance to public water systems within the State. For fiscal year 1995 and
each fiscal year thereafter, each State may
use up to an additional 10 percent of the funds
allotted to the State under this section—
(A) for public water system supervision
programs under section 300j–2(a) of this title;
(B) to administer or provide technical assistance through source water protection
programs;
(C) to develop and implement a capacity
development strategy under section 300g–9(c)
of this title; and
(D) for an operator certification program
for purposes of meeting the requirements of
section 300g–8 of this title,
if the State matches the expenditures with at
least an equal amount of State funds. At least
half of the match must be additional to the
amount expended by the State for public
water supervision in fiscal year 1993. An additional 2 percent of the funds annually allotted
to each State under this section may be used
by the State to provide technical assistance to
public water systems serving 10,000 or fewer
persons in the State. Funds utilized under subparagraph (B) shall not be used for enforcement actions.
(3) Guidance and regulations
The Administrator shall publish guidance
and promulgate regulations as may be necessary to carry out the provisions of this section, including—
(A) provisions to ensure that each State
commits and expends funds allotted to the
State under this section as efficiently as

§ 300j–12

possible in accordance with this subchapter
and applicable State laws;
(B) guidance to prevent waste, fraud, and
abuse; and
(C) guidance to avoid the use of funds
made available under this section to finance
the expansion of any public water system in
anticipation of future population growth.
The guidance and regulations shall also ensure
that the States, and public water systems receiving assistance under this section, use accounting, audit, and fiscal procedures that
conform to generally accepted accounting
standards.
(4) State report
Each State administering a loan fund and
assistance program under this subsection shall
publish and submit to the Administrator a report every 2 years on its activities under this
section, including the findings of the most recent audit of the fund and the entire State allotment. The Administrator shall periodically
audit all State loan funds established by, and
all other amounts allotted to, the States pursuant to this section in accordance with procedures established by the Comptroller General.
(h) Needs survey
The Administrator shall conduct an assessment of water system capital improvement
needs of all eligible public water systems in the
United States and submit a report to the Congress containing the results of the assessment
within 180 days after August 6, 1996, and every 4
years thereafter.
(i) Indian Tribes
(1) In general
11⁄2 percent of the amounts appropriated annually to carry out this section may be used
by the Administrator to make grants to Indian Tribes and Alaska Native villages that
have not otherwise received either grants from
the Administrator under this section or assistance from State loan funds established under
this section. The grants may only be used for
expenditures by tribes and villages for public
water system expenditures referred to in subsection (a)(2) of this section.
(2) Use of funds
Funds reserved pursuant to paragraph (1)
shall be used to address the most significant
threats to public health associated with public
water systems that serve Indian Tribes, as determined by the Administrator in consultation with the Director of the Indian Health
Service and Indian Tribes.
(3) Alaska Native villages
In the case of a grant for a project under this
subsection in an Alaska Native village, the
Administrator is also authorized to make
grants to the State of Alaska for the benefit of
Native villages. An amount not to exceed 4
percent of the grant amount may be used by
the State of Alaska for project management.
(4) Needs assessment
The Administrator, in consultation with the
Director of the Indian Health Service and In-

§ 300j–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

dian Tribes, shall, in accordance with a schedule that is consistent with the needs surveys
conducted pursuant to subsection (h) of this
section, prepare surveys and assess the needs
of drinking water treatment facilities to serve
Indian Tribes, including an evaluation of the
public water systems that pose the most significant threats to public health.
(j) Other areas
Of the funds annually available under this section for grants to States, the Administrator
shall make allotments in accordance with section 300j–2(a)(4) of this title for the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, and Guam. The
grants allotted as provided in this subsection
may be provided by the Administrator to the
governments of such areas, to public water systems in such areas, or to both, to be used for the
public water system expenditures referred to in
subsection (a)(2) of this section. The grants, and
grants for the District of Columbia, shall not be
deposited in State loan funds. The total allotment of grants under this section for all areas
described in this subsection in any fiscal year
shall not exceed 0.33 percent of the aggregate
amount made available to carry out this section
in that fiscal year.
(k) Other authorized activities
(1) In general
Notwithstanding subsection (a)(2) of this
section, a State may take each of the following actions:
(A) Provide assistance, only in the form of
a loan, to one or more of the following:
(i) Any public water system described in
subsection (a)(2) of this section to acquire
land or a conservation easement from a
willing seller or grantor, if the purpose of
the acquisition is to protect the source
water of the system from contamination
and to ensure compliance with national
primary drinking water regulations.
(ii) Any community water system to implement local, voluntary source water protection measures to protect source water
in areas delineated pursuant to section
300j–13 of this title, in order to facilitate
compliance with national primary drinking water regulations applicable to the
system under section 300g–1 of this title or
otherwise significantly further the health
protection objectives of this subchapter.
Funds authorized under this clause may be
used to fund only voluntary, incentivebased mechanisms.
(iii) Any community water system to
provide funding in accordance with section
300j–14(a)(1)(B)(i) of this title.
(B) Provide assistance, including technical
and financial assistance, to any public water
system as part of a capacity development
strategy developed and implemented in accordance with section 300g–9(c) of this title.
(C) Make expenditures from the capitalization grant of the State for fiscal years 1996
and 1997 to delineate and assess source water
protection areas in accordance with section
300j–13 of this title, except that funds set

Page 1034

aside for such expenditure shall be obligated
within 4 fiscal years.
(D) Make expenditures from the fund for
the establishment and implementation of
wellhead protection programs under section
300h–7 of this title.
(2) Limitation
For each fiscal year, the total amount of assistance provided and expenditures made by a
State under this subsection may not exceed 15
percent of the amount of the capitalization
grant received by the State for that year and
may not exceed 10 percent of that amount for
any one of the following activities:
(A) To acquire land or conservation easements pursuant to paragraph (1)(A)(i).
(B) To provide funding to implement voluntary, incentive-based source water quality
protection measures pursuant to clauses (ii)
and (iii) of paragraph (1)(A).
(C) To provide assistance through a capacity development strategy pursuant to paragraph (1)(B).
(D) To make expenditures to delineate or
assess source water protection areas pursuant to paragraph (1)(C).
(E) To make expenditures to establish and
implement wellhead protection programs
pursuant to paragraph (1)(D).
(3) Statutory construction
Nothing in this section creates or conveys
any new authority to a State, political subdivision of a State, or community water system for any new regulatory measure, or limits
any authority of a State, political subdivision
of a State or community water system.
(l) Savings
The failure or inability of any public water
system to receive funds under this section or
any other loan or grant program, or any delay in
obtaining the funds, shall not alter the obligation of the system to comply in a timely manner
with all applicable drinking water standards and
requirements of this subchapter.
(m) Authorization of appropriations
There are authorized to be appropriated to
carry out the purposes of this section $599,000,000
for the fiscal year 1994 and $1,000,000,000 for each
of the fiscal years 1995 through 2003. To the extent amounts authorized to be appropriated
under this subsection in any fiscal year are not
appropriated in that fiscal year, such amounts
are authorized to be appropriated in a subsequent fiscal year (prior to the fiscal year 2004).
Such sums shall remain available until expended.
(n) Health effects studies
From funds appropriated pursuant to this section for each fiscal year, the Administrator
shall reserve $10,000,000 for health effects studies
on drinking water contaminants authorized by
the Safe Drinking Water Act Amendments of
1996. In allocating funds made available under
this subsection, the Administrator shall give
priority to studies concerning the health effects
of cryptosporidium (as authorized by section
300j–18(c) of this title), disinfection byproducts
(as authorized by section 300j–18(c) of this title),

Page 1035

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and
arsenic
(as
authorized
by
section
300g–1(b)(12)(A) of this title), and the implementation of a plan for studies of subpopulations at
greater risk of adverse effects (as authorized by
section 300j–18(a) of this title).
(o) Monitoring for unregulated contaminants
From funds appropriated pursuant to this section for each fiscal year beginning with fiscal
year 1998, the Administrator shall reserve
$2,000,000 to pay the costs of monitoring for unregulated
contaminants
under
section
300j–4(a)(2)(C) of this title.
(p) Demonstration project for State of Virginia
Notwithstanding the other provisions of this
section limiting the use of funds deposited in a
State loan fund from any State allotment, the
State of Virginia may, as a single demonstration and with the approval of the Virginia General Assembly and the Administrator, conduct a
program to demonstrate alternative approaches
to intergovernmental coordination to assist in
the financing of new drinking water facilities in
the following rural communities in southwestern Virginia where none exists on August 6, 1996,
and where such communities are experiencing
economic hardship: Lee County, Wise County,
Scott County, Dickenson County, Russell County, Buchanan County, Tazewell County, and the
city of Norton, Virginia. The funds allotted to
that State and deposited in the State loan fund
may be loaned to a regional endowment fund for
the purpose set forth in this subsection under a
plan to be approved by the Administrator. The
plan may include an advisory group that includes representatives of such counties.
(q) Small system technical assistance
The Administrator may reserve up to 2 percent of the total funds appropriated pursuant to
subsection (m) of this section for each of the fiscal years 1997 through 2003 to carry out the provisions of section 300j–1(e) of this title (relating
to technical assistance for small systems), except that the total amount of funds made available for such purpose in any fiscal year through
appropriations (as authorized by section
300j–1(e) of this title) and reservations made pursuant to this subsection shall not exceed the
amount authorized by section 300j–1(e) of this
title.
(r) Evaluation
The Administrator shall conduct an evaluation of the effectiveness of the State loan funds
through fiscal year 2001. The evaluation shall be
submitted to the Congress at the same time as
the President submits to the Congress, pursuant
to section 1108 of title 31, an appropriations request for fiscal year 2003 relating to the budget
of the Environmental Protection Agency.
(July 1, 1944, ch. 373, title XIV, § 1452, as added
Pub. L. 104–182, title I, § 130, Aug. 6, 1996, 110
Stat. 1662.)
REFERENCES IN TEXT
The Safe Drinking Water Act Amendments of 1996, referred to in subsec. (n), is Pub. L. 104–182, Aug. 6, 1996,
110 Stat. 1613. For complete classification of this Act to
the Code, see Short Title of 1996 Amendment note set
out under section 201 of this title and Tables.

§ 300j–13

COMBINING FUND ASSETS FOR ENHANCEMENT OF
LENDING CAPACITY
Pub. L. 105–276, title III, Oct. 21, 1998, 112 Stat. 2498,
provided in part: ‘‘That, consistent with section 1452(g)
of the Safe Drinking Water Act (42 U.S.C. 300j–12(g)),
section 302 of the Safe Drinking Water Act Amendments of 1996 (Public Law 104–182) [set out as a note
below] and the accompanying joint explanatory statement of the committee of conference (H. Rept. No.
104–741 to accompany S. 1316, the Safe Drinking Water
Act Amendments of 1996), and notwithstanding any
other provision of law, beginning in fiscal year 1999 and
thereafter, States may combine the assets of State Revolving Funds (SRFs) established under section 1452 of
the Safe Drinking Water Act, as amended, and title VI
of the Federal Water Pollution Control Act [33 U.S.C.
1381 et seq.], as amended, as security for bond issues to
enhance the lending capacity of one or both SRFs, but
not to acquire the state match for either program, provided that revenues from the bonds are allocated to the
purposes of the Safe Drinking Water Act [this subchapter] and the Federal Water Pollution Control Act
[33 U.S.C. 1251 et seq.] in the same portion as the funds
are used as security for the bonds’’.
TRANSFER OF FUNDS
Pub. L. 109–54, title II, Aug. 2, 2005, 119 Stat. 530, provided in part: ‘‘That for fiscal year 2006 and thereafter,
State authority under section 302(a) of Public Law
104–182 [set out as a note below] shall remain in effect’’.
Similar provisions were contained in the following
prior appropriation acts:
Pub. L. 108–447, div. I, title III, Dec. 8, 2004, 118 Stat.
3330.
Pub. L. 108–199, div. G, title III, Jan. 23, 2004, 118 Stat.
406.
Pub. L. 108–7, div. K, title III, Feb. 20, 2003, 117 Stat.
512.
Pub. L. 107–73, title III, Nov. 26, 2001, 115 Stat. 685.
Section 302 of Pub. L. 104–182 provided that:
‘‘(a) IN GENERAL.—Notwithstanding any other provision of law, at any time after the date 1 year after a
State establishes a State loan fund pursuant to section
1452 of the Safe Drinking Water Act [this section] but
prior to fiscal year 2002, a Governor of the State may—
‘‘(1) reserve up to 33 percent of a capitalization
grant made pursuant to such section 1452 and add the
funds reserved to any funds provided to the State
pursuant to section 601 of the Federal Water Pollution Control Act (33 U.S.C. 1381); and
‘‘(2) reserve in any year a dollar amount up to the
dollar amount that may be reserved under paragraph
(1) for that year from capitalization grants made pursuant to section 601 of such Act (33 U.S.C. 1381) and
add the reserved funds to any funds provided to the
State pursuant to section 1452 of the Safe Drinking
Water Act.
‘‘(b) REPORT.—Not later than 4 years after the date of
enactment of this Act [Aug. 6, 1996], the Administrator
shall submit a report to the Congress regarding the implementation of this section, together with the Administrator’s recommendations, if any, for modifications
or improvement.
‘‘(c) STATE MATCH.—Funds reserved pursuant to this
section shall not be considered to be a State match of
a capitalization grant required pursuant to section 1452
of the Safe Drinking Water Act or the Federal Water
Pollution Control Act (33 U.S.C. 1251 et seq.).’’

§ 300j–13. Source water quality assessment
(a) Source water assessment
(1) Guidance
Within 12 months after August 6, 1996, after
notice and comment, the Administrator shall
publish guidance for States exercising primary
enforcement responsibility for public water
systems to carry out directly or through dele-

§ 300j–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

gation (for the protection and benefit of public
water systems and for the support of monitoring flexibility) a source water assessment program within the State’s boundaries. Each
State adopting modifications to monitoring
requirements pursuant to section 300g–7(b) of
this title shall, prior to adopting such modifications, have an approved source water assessment program under this section and shall
carry out the program either directly or
through delegation.
(2) Program requirements
A source water assessment program under
this subsection shall—
(A) delineate the boundaries of the assessment areas in such State from which one or
more public water systems in the State receive supplies of drinking water, using all
reasonably available hydrogeologic information on the sources of the supply of drinking
water in the State and the water flow, recharge, and discharge and any other reliable
information as the State deems necessary to
adequately determine such areas; and
(B) identify for contaminants regulated
under this subchapter for which monitoring
is required under this subchapter (or any unregulated contaminants selected by the
State, in its discretion, which the State, for
the purposes of this subsection, has determined may present a threat to public
health), to the extent practical, the origins
within each delineated area of such contaminants to determine the susceptibility of the
public water systems in the delineated area
to such contaminants.
(3) Approval, implementation, and monitoring
relief
A State source water assessment program
under this subsection shall be submitted to
the Administrator within 18 months after the
Administrator’s guidance is issued under this
subsection and shall be deemed approved 9
months after the date of such submittal unless
the Administrator disapproves the program as
provided in section 300h–7(c) of this title.
States shall begin implementation of the program immediately after its approval. The Administrator’s approval of a State program
under this subsection shall include a timetable, established in consultation with the
State, allowing not more than 2 years for completion after approval of the program. Public
water systems seeking monitoring relief in addition to the interim relief provided under section 300g–7(a) of this title shall be eligible for
monitoring relief, consistent with section
300g–7(b) of this title, upon completion of the
assessment in the delineated source water assessment area or areas concerned.
(4) Timetable
The timetable referred to in paragraph (3)
shall take into consideration the availability
to the State of funds under section 300j–12 of
this title (relating to State loan funds) for assessments and other relevant factors. The Administrator may extend any timetable included in a State program approved under
paragraph (3) to extend the period for completion by an additional 18 months.

Page 1036

(5) Demonstration project
The Administrator shall, as soon as practicable, conduct a demonstration project, in
consultation with other Federal agencies, to
demonstrate the most effective and protective
means of assessing and protecting source waters serving large metropolitan areas and located on Federal lands.
(6) Use of other programs
To avoid duplication and to encourage efficiency, the program under this section may
make use of any of the following:
(A) Vulnerability assessments, sanitary
surveys, and monitoring programs.
(B) Delineations or assessments of ground
water sources under a State wellhead protection program developed pursuant to this section.
(C) Delineations or assessments of surface
or ground water sources under a State pesticide management plan developed pursuant
to the Pesticide and Ground Water State
Management Plan Regulation (subparts I
and J of part 152 of title 40, Code of Federal
Regulations), promulgated under section
136a(d) of title 7.
(D) Delineations or assessments of surface
water sources under a State watershed initiative or to satisfy the watershed criterion
for determining if filtration is required
under the Surface Water Treatment Rule
(section 141.70 of title 40, Code of Federal
Regulations).
(E) Delineations or assessments of surface
or ground water sources under programs or
plans pursuant to the Federal Water Pollution Control Act [33 U.S.C. 1251 et seq.].
(7) Public availability
The State shall make the results of the
source water assessments conducted under
this subsection available to the public.
(b) Approval and disapproval
For provisions relating to program approval
and disapproval, see section 300h–7(c) of this
title.
(July 1, 1944, ch. 373, title XIV, § 1453, as added
Pub. L. 104–182, title I, § 132(a), Aug. 6, 1996, 110
Stat. 1673.)
REFERENCES IN TEXT
The Federal Water Pollution Control Act, referred to
in subsec. (a)(6)(E), is act June 30, 1948, ch. 758, as
amended generally by Pub. L. 92–500, § 2, Oct. 18, 1972, 86
Stat. 816, which is classified generally to chapter 26
(§ 1251 et seq.) of Title 33, Navigation and Navigable Waters. For complete classification of this Act to the
Code, see Short Title note set out under section 1251 of
Title 33 and Tables.

§ 300j–14. Source water petition program
(a) Petition program
(1) In general
(A) Establishment
A State may establish a program under
which an owner or operator of a community
water system in the State, or a municipal or
local government or political subdivision of
a State, may submit a source water quality

Page 1037

TITLE 42—THE PUBLIC HEALTH AND WELFARE

protection partnership petition to the State
requesting that the State assist in the local
development of a voluntary, incentive-based
partnership, among the owner, operator, or
government and other persons likely to be
affected by the recommendations of the
partnership, to—
(i) reduce the presence in drinking water
of contaminants that may be addressed by
a petition by considering the origins of the
contaminants, including to the maximum
extent practicable the specific activities
that affect the drinking water supply of a
community;
(ii) obtain financial or technical assistance necessary to facilitate establishment
of a partnership, or to develop and implement recommendations of a partnership
for the protection of source water to assist
in the provision of drinking water that
complies with national primary drinking
water regulations with respect to contaminants addressed by a petition; and
(iii) develop recommendations regarding
voluntary and incentive-based strategies
for the long-term protection of the source
water of community water systems.
(B) Funding
Each State may—
(i) use funds set aside pursuant to section 300j–12(k)(1)(A)(iii) of this title by the
State to carry out a program described in
subparagraph (A), including assistance to
voluntary local partnerships for the development and implementation of partnership
recommendations for the protection of
source water such as source water quality
assessment, contingency plans, and demonstration projects for partners within a
source water area delineated under section
300j–13(a) of this title; and
(ii) provide assistance in response to a
petition submitted under this subsection
using funds referred to in subsection
(b)(2)(B) of this section.
(2) Objectives
The objectives of a petition submitted under
this subsection shall be to—
(A) facilitate the local development of voluntary, incentive-based partnerships among
owners and operators of community water
systems, governments, and other persons in
source water areas; and
(B) obtain assistance from the State in
identifying resources which are available to
implement the recommendations of the partnerships to address the origins of drinking
water contaminants that may be addressed
by a petition (including to the maximum extent practicable the specific activities contributing to the presence of the contaminants) that affect the drinking water supply
of a community.
(3) Contaminants addressed by a petition
A petition submitted to a State under this
subsection may address only those contaminants—
(A) that are pathogenic organisms for
which a national primary drinking water

§ 300j–14

regulation has been established or is required under section 300g–1 of this title; or
(B) for which a national primary drinking
water regulation has been promulgated or
proposed and that are detected by adequate
monitoring methods in the source water at
the intake structure or in any collection,
treatment, storage, or distribution facilities
by the community water systems at levels—
(i) above the maximum contaminant
level; or
(ii) that are not reliably and consistently
below the maximum contaminant level.
(4) Contents
A petition submitted under this subsection
shall, at a minimum—
(A) include a delineation of the source
water area in the State that is the subject of
the petition;
(B) identify, to the maximum extent practicable, the origins of the drinking water
contaminants that may be addressed by a
petition (including to the maximum extent
practicable the specific activities contributing to the presence of the contaminants) in
the source water area delineated under section 300j–13 of this title;
(C) identify any deficiencies in information that will impair the development of recommendations by the voluntary local partnership to address drinking water contaminants that may be addressed by a petition;
(D) specify the efforts made to establish
the voluntary local partnership and obtain
the participation of—
(i) the municipal or local government or
other political subdivision of the State
with jurisdiction over the source water
area delineated under section 300j–13 of
this title; and
(ii) each person in the source water area
delineated under section 300j–13 of this
title—
(I) who is likely to be affected by recommendations of the voluntary local
partnership; and
(II) whose participation is essential to
the success of the partnership;
(E) outline how the voluntary local partnership has or will, during development and
implementation of recommendations of the
voluntary local partnership, identify, recognize and take into account any voluntary or
other activities already being undertaken by
persons in the source water area delineated
under section 300j–13 of this title under Federal or State law to reduce the likelihood
that contaminants will occur in drinking
water at levels of public health concern; and
(F) specify the technical, financial, or
other assistance that the voluntary local
partnership requests of the State to develop
the partnership or to implement recommendations of the partnership.
(b) Approval or disapproval of petitions
(1) In general
After providing notice and an opportunity
for public comment on a petition submitted
under subsection (a) of this section, the State

§ 300j–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

shall approve or disapprove the petition, in
whole or in part, not later than 120 days after
the date of submission of the petition.
(2) Approval
The State may approve a petition if the petition meets the requirements established under
subsection (a) of this section. The notice of approval shall, at a minimum, include for informational purposes—
(A) an identification of technical, financial, or other assistance that the State will
provide to assist in addressing the drinking
water contaminants that may be addressed
by a petition based on—
(i) the relative priority of the public
health concern identified in the petition
with respect to the other water quality
needs identified by the State;
(ii) any necessary coordination that the
State will perform of the program established under this section with programs
implemented or planned by other States
under this section; and
(iii) funds available (including funds
available from a State revolving loan fund
established under title VI of the Federal
Water Pollution Control Act (33 U.S.C. 1381
et seq.)) or section 300j–12 of this title;
(B) a description of technical or financial
assistance pursuant to Federal and State
programs that is available to assist in implementing recommendations of the partnership in the petition, including—
(i) any program established under the
Federal Water Pollution Control Act (33
U.S.C. 1251 et seq.);
(ii) the program established under section 1455b of title 16;
(iii) the agricultural water quality protection program established under chapter
2 of subtitle D of title XII of the Food Security Act of 1985 (16 U.S.C. 3838 et seq.);
(iv) the sole source aquifer protection
program established under section 300h–6
of this title;
(v) the community wellhead protection
program established under section 300h–7
of this title;
(vi) any pesticide or ground water management plan;
(vii) any voluntary agricultural resource
management plan or voluntary whole farm
or whole ranch management plan developed and implemented under a process established by the Secretary of Agriculture;
and
(viii) any abandoned well closure program; and
(C) a description of activities that will be
undertaken to coordinate Federal and State
programs to respond to the petition.
(3) Disapproval
If the State disapproves a petition submitted
under subsection (a) of this section, the State
shall notify the entity submitting the petition
in writing of the reasons for disapproval. A petition may be resubmitted at any time if—
(A) new information becomes available;
(B) conditions affecting the source water
that is the subject of the petition change; or

Page 1038

(C) modifications are made in the type of
assistance being requested.
(c) Grants to support State programs
(1) In general
The Administrator may make a grant to
each State that establishes a program under
this section that is approved under paragraph
(2). The amount of each grant shall not exceed
50 percent of the cost of administering the program for the year in which the grant is available.
(2) Approval
In order to receive grant assistance under
this subsection, a State shall submit to the
Administrator for approval a plan for a source
water quality protection partnership program
that is consistent with the guidance published
under subsection (d) of this section. The Administrator shall approve the plan if the plan
is consistent with the guidance published
under subsection (d) of this section.
(d) Guidance
(1) In general
Not later than 1 year after August 6, 1996,
the Administrator, in consultation with the
States, shall publish guidance to assist—
(A) States in the development of a source
water quality protection partnership program; and
(B) municipal or local governments or political subdivisions of a State and community water systems in the development of
source water quality protection partnerships
and in the assessment of source water quality.
(2) Contents of the guidance
The guidance shall, at a minimum—
(A) recommend procedures for the approval or disapproval by a State of a petition submitted under subsection (a) of this
section;
(B) recommend procedures for the submission of petitions developed under subsection
(a) of this section;
(C) recommend criteria for the assessment
of source water areas within a State; and
(D) describe technical or financial assistance pursuant to Federal and State programs that is available to address the contamination of sources of drinking water and
to develop and respond to petitions submitted under subsection (a) of this section.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $5,000,000 for each of the
fiscal years 1997 through 2003. Each State with a
plan for a program approved under subsection
(b) of this section shall receive an equitable portion of the funds available for any fiscal year.
(f) Statutory construction
Nothing in this section—
(1)(A) creates or conveys new authority to a
State, political subdivision of a State, or community water system for any new regulatory
measure; or
(B) limits any authority of a State, political
subdivision, or community water system; or

Page 1039

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) precludes a community water system,
municipal or local government, or political
subdivision of a government from locally developing and carrying out a voluntary, incentive-based, source water quality protection
partnership to address the origins of drinking
water contaminants of public health concern.
(July 1, 1944, ch. 373, title XIV, § 1454, as added
Pub. L. 104–182, title I, § 133(a), Aug. 6, 1996, 110
Stat. 1675.)
REFERENCES IN TEXT
The Federal Water Pollution Control Act, referred to
in subsec. (b)(2)(A)(iii), (B)(i), is act June 30, 1948, ch.
758, as amended generally by Pub. L. 92–500, § 2, Oct. 18,
1972, 86 Stat. 816, which is classified generally to chapter 26 (§ 1251 et seq.) of Title 33, Navigation and Navigable Waters. Title VI of the Act is classified generally
to subchapter VI (§ 1381 et seq.) of chapter 26 of Title 33.
For complete classification of this Act to the Code, see
Short Title note set out under section 1251 of Title 33
and Tables.
The Food Security Act of 1985, referred to in subsec.
(b)(2)(B)(iii), is Pub. L. 99–198, Dec. 23, 1985, 99 Stat. 1354,
as amended. Chapter 2 of subtitle D of title XII of the
Act was classified generally to part II (§ 3838 et seq.) of
subchapter IV of chapter 58 of Title 16, Conservation,
prior to repeal by Pub. L. 104–127, title III, § 336(h), Apr.
4, 1996, 110 Stat. 1007. For complete classification of this
Act to the Code, see Short Title of 1985 Amendment
note set out under section 1281 of Title 7, Agriculture,
and Tables.

§ 300j–15. Water conservation plan
(a) Guidelines
Not later than 2 years after August 6, 1996, the
Administrator shall publish in the Federal Register guidelines for water conservation plans for
public water systems serving fewer than 3,300
persons, public water systems serving between
3,300 and 10,000 persons, and public water systems serving more than 10,000 persons, taking
into consideration such factors as water availability and climate.
(b) Loans or grants
Within 1 year after publication of the guidelines under subsection (a) of this section, a
State exercising primary enforcement responsibility for public water systems may require a
public water system, as a condition of receiving
a loan or grant from a State loan fund under
section 300j–12 of this title, to submit with its
application for such loan or grant a water conservation plan consistent with such guidelines.

§ 300j–18

(B) is located along the United StatesMexico border (generally in an unincorporated area); and
(C) lacks a safe drinking water supply or
adequate facilities for the provision of safe
drinking water for human consumption.
(b) Grants to alleviate health risks
The Administrator of the Environmental Protection Agency and the heads of other appropriate Federal agencies are authorized to award
grants to a border State to provide assistance to
eligible communities to facilitate compliance
with national primary drinking water regulations or otherwise significantly further the
health protection objectives of this subchapter.
(c) Use of funds
Each grant awarded pursuant to subsection (b)
of this section shall be used to provide assistance to one or more eligible communities with
respect to which the residents are subject to a
significant health risk (as determined by the
Administrator or the head of the Federal agency
making the grant) attributable to the lack of
access to an adequate and affordable drinking
water supply system.
(d) Cost sharing
The amount of a grant awarded pursuant to
this section shall not exceed 50 percent of the
costs of carrying out the project that is the subject of the grant.
(e) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $25,000,000 for each of the
fiscal years 1997 through 1999.
(July 1, 1944, ch. 373, title XIV, § 1456, as added
Pub. L. 104–182, title I, § 135, Aug. 6, 1996, 110
Stat. 1679.)
§ 300j–17. Estrogenic substances screening program
In addition to the substances referred to in
section 346a(p)(3)(B) of title 21 the Administrator may provide for testing under the screening program authorized by section 346a(p) of
title 21, in accordance with the provisions of section 346a(p) of title 21, of any other substance
that may be found in sources of drinking water
if the Administrator determines that a substantial population may be exposed to such substance.

(July 1, 1944, ch. 373, title XIV, § 1455, as added
Pub. L. 104–182, title I, § 134, Aug. 6, 1996, 110
Stat. 1679.)

(July 1, 1944, ch. 373, title XIV, § 1457, as added
Pub. L. 104–182, title I, § 136, Aug. 6, 1996, 110
Stat. 1680.)

§ 300j–16. Assistance to colonias

§ 300j–18. Drinking water studies

(a) Definitions
As used in this section:
(1) Border State
The term ‘‘border State’’ means Arizona,
California, New Mexico, and Texas.
(2) Eligible community
The term ‘‘eligible community’’ means a
low-income community with economic hardship that—
(A) is commonly referred to as a colonia;

(a) Subpopulations at greater risk
(1) In general
The Administrator shall conduct a continuing program of studies to identify groups within the general population that may be at
greater risk than the general population of adverse health effects from exposure to contaminants in drinking water. The study shall examine whether and to what degree infants,
children, pregnant women, the elderly, individuals with a history of serious illness, or

§ 300j–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE

other subpopulations that can be identified
and characterized are likely to experience elevated health risks, including risks of cancer,
from contaminants in drinking water.
(2) Report
Not later than 4 years after August 6, 1996,
and periodically thereafter as new and significant information becomes available, the Administrator shall report to the Congress on
the results of the studies.
(b) Biological mechanisms
The Administrator shall conduct biomedical
studies to—
(1) understand the mechanisms by which
chemical contaminants are absorbed, distributed, metabolized, and eliminated from the
human body, so as to develop more accurate
physiologically based models of the phenomena;
(2) understand the effects of contaminants
and the mechanisms by which the contaminants cause adverse effects (especially noncancer and infectious effects) and the variations
in the effects among humans, especially subpopulations at greater risk of adverse effects,
and between test animals and humans; and
(3) develop new approaches to the study of
complex mixtures, such as mixtures found in
drinking water, especially to determine the
prospects for synergistic or antagonistic interactions that may affect the shape of the doseresponse relationship of the individual chemicals and microbes, and to examine noncancer
endpoints and infectious diseases, and susceptible individuals and subpopulations.
(c) Studies on harmful substances in drinking
water
(1) Development of studies
The Administrator shall, not later than 180
days after August 6, 1996, and after consultation with the Secretary of Health and Human
Services, the Secretary of Agriculture, and, as
appropriate, the heads of other Federal agencies, conduct the studies described in paragraph (2) to support the development and implementation of the most current version of
each of the following:
(A) Enhanced Surface Water Treatment
Rule (59 Fed. Reg. 38832 (July 29, 1994)).
(B) Disinfectant and Disinfection Byproducts Rule (59 Fed. Reg. 38668 (July 29, 1994)).
(C) Ground Water Disinfection Rule (availability of draft summary announced at (57
Fed. Reg. 33960; July 31, 1992)).
(2) Contents of studies
The studies required by paragraph (1) shall
include, at a minimum, each of the following:
(A) Toxicological studies and, if warranted, epidemiological studies to determine
what levels of exposure from disinfectants
and disinfection byproducts, if any, may be
associated with developmental and birth defects and other potential toxic end points.
(B) Toxicological studies and, if warranted, epidemiological studies to quantify
the carcinogenic potential from exposure to
disinfection byproducts resulting from different disinfectants.

Page 1040

(C) The development of dose-response
curves for pathogens, including cryptosporidium and the Norwalk virus.
(3) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection $12,500,000 for each of
fiscal years 1997 through 2003.
(d) Waterborne disease occurrence study
(1) System
The Director of the Centers for Disease Control and Prevention, and the Administrator
shall jointly—
(A) within 2 years after August 6, 1996, conduct pilot waterborne disease occurrence
studies for at least 5 major United States
communities or public water systems; and
(B) within 5 years after August 6, 1996, prepare a report on the findings of the pilot
studies, and a national estimate of waterborne disease occurrence.
(2) Training and education
The Director and Administrator shall jointly establish a national health care provider
training and public education campaign to inform both the professional health care provider community and the general public about
waterborne disease and the symptoms that
may be caused by infectious agents, including
microbial contaminants. In developing such a
campaign, they shall seek comment from interested groups and individuals, including scientists, physicians, State and local governments, environmental groups, public water
systems, and vulnerable populations.
(3) Funding
There are authorized to be appropriated for
each of the fiscal years 1997 through 2001,
$3,000,000 to carry out this subsection. To the
extent funds under this subsection are not
fully appropriated, the Administrator may use
not more than $2,000,000 of the funds from
amounts reserved under section 300j–12(n) of
this title for health effects studies for purposes of this subsection. The Administrator
may transfer a portion of such funds to the
Centers for Disease Control and Prevention for
such purposes.
(July 1, 1944, ch. 373, title XIV, § 1458, as added
Pub. L. 104–182, title I, § 137, Aug. 6, 1996, 110
Stat. 1680.)
PUBLIC HEALTH ASSESSMENT OF EXPOSURE TO
PERCHLORATE
Pub. L. 108–136, div. A, title III, § 323, Nov. 24, 2003, 117
Stat. 1440, provided that:
‘‘(a) EPIDEMIOLOGICAL STUDY OF EXPOSURE TO PERCHLORATE.—The Secretary of Defense shall provide for
an independent epidemiological study of exposure to
perchlorate in drinking water. The entity conducting
the study shall—
‘‘(1) assess the incidence of thyroid disease and
measurable effects of thyroid function in relation to
exposure to perchlorate;
‘‘(2) ensure that the study is of sufficient scope and
scale to permit the making of meaningful conclusions
of the measurable public health threat associated
with exposure to perchlorate, especially the threat to
sensitive subpopulations; and
‘‘(3) examine thyroid function, including measurements of urinary iodine and thyroid hormone levels,

Page 1041

TITLE 42—THE PUBLIC HEALTH AND WELFARE

in a sufficient number of pregnant women, neonates,
and infants exposed to perchlorate in drinking water
and match measurements of perchlorate levels in the
drinking water of each study participant in order to
permit the development of meaningful conclusions on
the public health threat to individuals exposed to
perchlorate.
‘‘(b) REVIEW OF EFFECTS OF PERCHLORATE ON ENDOCRINE SYSTEM.—The Secretary shall provide for an
independent review of the effects of perchlorate on the
human endocrine system. The entity conducting the review shall assess—
‘‘(1) available data on human exposure to perchlorate, including clinical data and data on exposure
of sensitive subpopulations, and the levels at which
health effects were observed; and
‘‘(2) available data on other substances that have
endocrine effects similar to perchlorate to which the
public is frequently exposed.
‘‘(c) PERFORMANCE OF STUDY AND REVIEW.—(1) The
Secretary shall provide for the performance of the
study under subsection (a) through the Centers for Disease Control and Prevention, the National Institutes of
Health, or another Federal entity with experience in
environmental toxicology selected by the Secretary.
‘‘(2) The Secretary shall provide for the performance
of the review under subsection (b) through the Centers
for Disease Control and Prevention, the National Institutes of Health, or another appropriate Federal research entity with experience in human endocrinology
selected by the Secretary. The Secretary shall ensure
that the panel conducting the review is composed of individuals with expertise in human endocrinology.
‘‘(d) REPORTING REQUIREMENTS.—Not later than June
1, 2005, the Federal entities conducting the study and
review under this section shall submit to the Secretary
reports containing the results of the study and review.’’

PART F—ADDITIONAL REQUIREMENTS TO
REGULATE SAFETY OF DRINKING WATER
§ 300j–21. Definitions
As used in this part—
(1) Drinking water cooler
The term ‘‘drinking water cooler’’ means
any mechanical device affixed to drinking
water supply plumbing which actively cools
water for human consumption.
(2) Lead free
The term ‘‘lead free’’ means, with respect to
a drinking water cooler, that each part or
component of the cooler which may come in
contact with drinking water contains not
more than 8 percent lead, except that no
drinking water cooler which contains any solder, flux, or storage tank interior surface
which may come in contact with drinking
water shall be considered lead free if the solder, flux, or storage tank interior surface contains more than 0.2 percent lead. The Administrator may establish more stringent requirements for treating any part or component of a
drinking water cooler as lead free for purposes
of this part whenever he determines that any
such part may constitute an important source
of lead in drinking water.
(3) Local educational agency
The term ‘‘local educational agency’’
means—
(A) any local educational agency as defined in section 7801 of title 20,
(B) the owner of any private, nonprofit elementary or secondary school building, and

§ 300j–22

(C) the governing authority of any school
operating under the defense dependent’s education system provided for under the Defense Dependent’s Education Act of 1978 (20
U.S.C. 921 and following).
(4) Repair
The term ‘‘repair’’ means, with respect to a
drinking water cooler, to take such corrective
action as is necessary to ensure that water
cooler is lead free.
(5) Replacement
The term ‘‘replacement’’, when used with respect to a drinking water cooler, means the
permanent removal of the water cooler and
the installation of a lead free water cooler.
(6) School
The term ‘‘school’’ means any elementary
school or secondary school as defined in section 7801 of title 20 and any kindergarten or
day care facility.
(7) Lead-lined tank
The term ‘‘lead-lined tank’’ means a water
reservoir container in a drinking water cooler
which container is constructed of lead or
which has an interior surface which is not lead
free.
(July 1, 1944, ch. 373, title XIV, § 1461, as added
Pub. L. 100–572, § 2(a), Oct. 31, 1988, 102 Stat. 2884;
amended Pub. L. 103–382, title III, § 391(p), Oct.
20, 1994, 108 Stat. 4024; Pub. L. 104–182, title V,
§ 501(f)(7), Aug. 6, 1996, 110 Stat. 1692; Pub. L.
107–110, title X, § 1076(x), Jan. 8, 2002, 115 Stat.
2093.)
REFERENCES IN TEXT
The Defense Dependent’s Education Act of 1978, referred to in par. (3)(C), probably means the Defense Dependents’ Education Act of 1978, title XIV of Pub. L.
95–561, Nov. 1, 1978, 92 Stat. 2365, as amended, which is
classified principally to chapter 25A (§ 921 et seq.) of
Title 20, Education. For complete classification of this
Act to the Code, see Short Title note set out under section 921 of Title 20 and Tables.
AMENDMENTS
2002—Pars. (3)(A), (6). Pub. L. 107–110 substituted
‘‘section 7801 of title 20’’ for ‘‘section 8801 of title 20’’.
1996—Pub. L. 104–182 made technical amendment to
section catchline and first word of text.
1994—Par. (3)(A). Pub. L. 103–382, § 391(p)(1), substituted ‘‘section 8801 of title 20’’ for ‘‘section 198 of the
Elementary and Secondary Education Act of 1965 (20
U.S.C. 3381)’’.
Par. (6). Pub. L. 103–382, § 391(p)(2), substituted ‘‘section 8801 of title 20’’ for ‘‘section 198 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 2854)’’.
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107–110 effective Jan. 8, 2002,
except with respect to certain noncompetitive programs and competitive programs, see section 5 of Pub.
L. 107–110, set out as an Effective Date note under section 6301 of Title 20, Education.

§ 300j–22. Recall of drinking water coolers with
lead-lined tanks
For purposes of the Consumer Product Safety
Act [15 U.S.C. 2051 et seq.], all drinking water
coolers identified by the Administrator on the
list under section 300j–23 of this title as having

§ 300j–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

a lead-lined tank shall be considered to be imminently hazardous consumer products within the
meaning of section 12 of such Act (15 U.S.C.
2061). After notice and opportunity for comment,
including a public hearing, the Consumer Product Safety Commission shall issue an order requiring the manufacturers and importers of such
coolers to repair, replace, or recall and provide
a refund for such coolers within 1 year after October 31, 1988. For purposes of enforcement, such
order shall be treated as an order under section
15(d) of that Act (15 U.S.C. 2064(d)).
(July 1, 1944, ch. 373, title XIV, § 1462, as added
Pub. L. 100–572, § 2(a), Oct. 31, 1988, 102 Stat. 2885;
amended Pub. L. 104–182, title V, § 501(f)(8), Aug.
6, 1996, 110 Stat. 1692.)
REFERENCES IN TEXT
The Consumer Product Safety Act, referred to in
text, is Pub. L. 92–573, Oct. 27, 1972, 86 Stat. 1207, as
amended, which is classified generally to chapter 47
(§ 2051 et seq.) of Title 15, Commerce and Trade. For
complete classification of this Act to the Code, see
Short Title note set out under section 2051 of Title 15
and Tables.
AMENDMENTS
1996—Pub. L. 104–182 made technical amendment to
section catchline and first word of text.

§ 300j–23. Drinking water coolers containing lead
(a) Publication of lists
The Administrator shall, after notice and opportunity for public comment, identify each
brand and model of drinking water cooler which
is not lead free, including each brand and model
of drinking water cooler which has a lead-lined
tank. For purposes of identifying the brand and
model of drinking water coolers under this subsection, the Administrator shall use the best information available to the Environmental Protection Agency. Within 100 days after October
31, 1988, the Administrator shall publish a list of
each brand and model of drinking water cooler
identified under this subsection. Such list shall
separately identify each brand and model of
cooler which has a lead-lined tank. The Administrator shall continue to gather information regarding lead in drinking water coolers and shall
revise and republish the list from time to time
as may be appropriate as new information or
analysis becomes available regarding lead contamination in drinking water coolers.
(b) Prohibition
No person may sell in interstate commerce, or
manufacture for sale in interstate commerce,
any drinking water cooler listed under subsection (a) of this section or any other drinking
water cooler which is not lead free, including a
lead-lined drinking water cooler.
(c) Criminal penalty
Any person who knowingly violates the prohibition contained in subsection (b) of this section
shall be imprisoned for not more than 5 years, or
fined in accordance with title 18, or both.
(d) Civil penalty
The Administrator may bring a civil action in
the appropriate United States District Court (as
determined under the provisions of title 28) to

Page 1042

impose a civil penalty on any person who violates subsection (b) of this section. In any such
action the court may impose on such person a
civil penalty of not more than $5,000 ($50,000 in
the case of a second or subsequent violation).
(July 1, 1944, ch. 373, title XIV, § 1463, as added
Pub. L. 100–572, § 2(a), Oct. 31, 1988, 102 Stat. 2885;
amended Pub. L. 104–182, title V, § 501(f)(9), Aug.
6, 1996, 110 Stat. 1692.)
AMENDMENTS
1996—Pub. L. 104–182 made technical amendment to
section catchline and subsec. (a) designation.

§ 300j–24. Lead contamination in school drinking
water
(a) Distribution of drinking water cooler list
Within 100 days after October 31, 1988, the Administrator shall distribute to the States a list
of each brand and model of drinking water cooler identified and listed by the Administrator
under section 300j–23(a) of this title.
(b) Guidance document and testing protocol
The Administrator shall publish a guidance
document and a testing protocol to assist
schools in determining the source and degree of
lead contamination in school drinking water
supplies and in remedying such contamination.
The guidance document shall include guidelines
for sample preservation. The guidance document
shall also include guidance to assist States,
schools, and the general public in ascertaining
the levels of lead contamination in drinking
water coolers and in taking appropriate action
to reduce or eliminate such contamination. The
guidance document shall contain a testing protocol for the identification of drinking water
coolers which contribute to lead contamination
in drinking water. Such document and protocol
may be revised, republished and redistributed as
the Administrator deems necessary. The Administrator shall distribute the guidance document
and testing protocol to the States within 100
days after October 31, 1988.
(c) Dissemination to schools, etc.
Each State shall provide for the dissemination
to local educational agencies, private nonprofit
elementary or secondary schools and to day care
centers of the guidance document and testing
protocol published under subsection (b) of this
section, together with the list of drinking water
coolers published under section 300j–23(a) of this
title.
(d) Remedial action program
(1) Testing and remedying lead contamination
Within 9 months after October 31, 1988, each
State shall establish a program, consistent
with this section, to assist local educational
agencies in testing for, and remedying, lead
contamination in drinking water from coolers
and from other sources of lead contamination
at schools under the jurisdiction of such agencies.
(2) Public availability
A copy of the results of any testing under
paragraph (1) shall be available in the administrative offices of the local educational agen-

Page 1043

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cy for inspection by the public, including
teachers, other school personnel, and parents.
The local educational agency shall notify parent, teacher, and employee organizations of
the availability of such testing results.
(3) Coolers
In the case of drinking water coolers, such
program shall include measures for the reduction or elimination of lead contamination
from those water coolers which are not lead
free and which are located in schools. Such
measures shall be adequate to ensure that
within 15 months after October 31, 1988, all
such water coolers in schools under the jurisdiction of such agencies are repaired, replaced,
permanently removed, or rendered inoperable
unless the cooler is tested and found (within
the limits of testing accuracy) not to contribute lead to drinking water.
(July 1, 1944, ch. 373, title XIV, § 1464, as added
Pub. L. 100–572, § 2(a), Oct. 31, 1988, 102 Stat. 2886;
amended Pub. L. 104–182, title V, § 501(f)(10), Aug.
6, 1996, 110 Stat. 1692.)
AMENDMENTS
1996—Pub. L. 104–182 made technical amendment to
section catchline and subsec. (a) designation.

§ 300j–25. Federal assistance for State programs
regarding lead contamination in school
drinking water
(a) School drinking water programs
The Administrator shall make grants to
States to establish and carry out State programs under section 300j–24 of this title to assist
local educational agencies in testing for, and
remedying, lead contamination in drinking
water from drinking water coolers and from
other sources of lead contamination at schools
under the jurisdiction of such agencies. Such
grants may be used by States to reimburse local
educational agencies for expenses incurred after
October 31, 1988, for such testing and remedial
action.
(b) Limits
Each grant under this section shall be used by
the State for testing water coolers in accordance with section 300j–24 of this title, for testing
for lead contamination in other drinking water
supplies under section 300j–24 of this title, or for
remedial action under State programs under
section 300j–24 of this title. Not more than 5 percent of the grant may be used for program administration.
(c) Authorization of appropriations
There are authorized to be appropriated to
carry out this section not more than $30,000,000
for fiscal year 1989, $30,000,000 for fiscal year
1990, and $30,000,000 for fiscal year 1991.
(July 1, 1944, ch. 373, title XIV, § 1465, as added
Pub. L. 100–572, § 2(a), Oct. 31, 1988, 102 Stat. 2887;
amended Pub. L. 104–182, title V, § 501(d), (f)(11),
Aug. 6, 1996, 110 Stat. 1691, 1692.)
AMENDMENTS
1996—Pub. L. 104–182, § 501(f)(11), made technical
amendment to section catchline and subsec. (a) designation.

§ 300k

Subsec. (b). Pub. L. 104–182, § 501(d), substituted ‘‘by
the State’’ for ‘‘as by the State’’.

§ 300j–26. Certification of testing laboratories
The Administrator of the Environmental Protection Agency shall assure that programs for
the certification of testing laboratories which
test drinking water supplies for lead contamination certify only those laboratories which provide reliable accurate testing. The Administrator (or the State in the case of a State to
which certification authority is delegated under
this subsection) shall publish and make available to the public upon request the list of laboratories certified under this subsection.1
(Pub. L. 100–572, § 4, Oct. 31, 1988, 102 Stat. 2889.)
CODIFICATION
Section enacted as part of the Lead Contamination
Control Act of 1988, and not as part of the Public
Health Service Act which comprises this chapter.

SUBCHAPTER XIII—PREVENTIVE HEALTH
MEASURES WITH RESPECT TO BREAST
AND CERVICAL CANCERS
§ 300k. Establishment of program of grants to
States
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to States on the basis of an established competitive review process for the
purpose of carrying out programs—
(1) to screen women for breast and cervical
cancer as a preventive health measure;
(2) to provide appropriate referrals for medical treatment of women screened pursuant to
paragraph (1) and to ensure, to the extent
practicable, the provision of appropriate follow-up services and support services such as
case management;
(3) to develop and disseminate public information and education programs for the detection and control of breast and cervical cancer;
(4) to improve the education, training, and
skills of health professionals (including allied
health professionals) in the detection and control of breast and cervical cancer;
(5) to establish mechanisms through which
the States can monitor the quality of screening procedures for breast and cervical cancer,
including the interpretation of such procedures; and
(6) to evaluate activities conducted under
paragraphs (1) through (5) through appropriate
surveillance or program-monitoring activities.
(b) Grant and contract authority of States
(1) In general
A State receiving a grant under subsection
(a) of this section may, subject to paragraphs
(2) and (3), expend the grant to carry out the
purpose described in such subsection through
grants to public and nonprofit private entities
and through contracts with public and private
entities.
(2) Certain applications
If a nonprofit private entity and a private
entity that is not a nonprofit entity both sub1 So

in original. Probably should be ‘‘section.’’

§ 300k

TITLE 42—THE PUBLIC HEALTH AND WELFARE

mit applications to a State to receive an
award of a grant or contract pursuant to paragraph (1), the State may give priority to the
application submitted by the nonprofit private
entity in any case in which the State determines that the quality of such application is
equivalent to the quality of the application
submitted by the other private entity.
(3) Payments for screenings
The amount paid by a State to an entity
under this subsection for a screening procedure under subsection (a)(1) of this section
may not exceed the amount that would be paid
under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] if payment
were made under such part for furnishing the
procedure to a woman enrolled under such
part.
(c) Special consideration for certain States
In making grants under subsection (a) of this
section to States whose initial grants under
such subsection are made for fiscal year 1995 or
any subsequent fiscal year, the Secretary shall
give special consideration to any State whose
proposal for carrying out programs under such
subsection—
(1) has been approved through a process of
peer review; and
(2) is made with respect to geographic areas
in which there is—
(A) a substantial rate of mortality from
breast or cervical cancer; or
(B) a substantial incidence of either of
such cancers.
(d) Coordinating committee regarding year 2020
health objectives
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish a committee to coordinate the
activities of the agencies of the Public Health
Service (and other appropriate Federal agencies)
that are carried out toward achieving the objectives established by the Secretary for reductions
in the rate of mortality from breast and cervical
cancer in the United States by the year 2020.
Such committee shall be comprised of Federal
officers or employees designated by the heads of
the agencies involved to serve on the committee
as representatives of the agencies, and such representatives from other public or private entities as the Secretary determines to be appropriate.
(July 1, 1944, ch. 373, title XV, § 1501, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 409;
amended Pub. L. 103–43, title XX, § 2008(c)(1),
June 10, 1993, 107 Stat. 211; Pub. L. 103–183, title
I, § 101(a), (b), (f), (g)(1), Dec. 14, 1993, 107 Stat.
2227–2229; Pub. L. 105–340, title II, § 203(a), (b),
Oct. 31, 1998, 112 Stat. 3194; Pub. L. 105–392, title
IV, § 401(b)(5), Nov. 13, 1998, 112 Stat. 3587; Pub. L.
110–18, § 2(1), Apr. 20, 2007, 121 Stat. 80.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(3),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Part B of title XVIII of the Act is classified generally
to part B (§ 1395j et seq.) of subchapter XVIII of chapter
7 of this title. For complete classification of this Act to
the Code, see section 1305 of this title and Tables.

Page 1044

PRIOR PROVISIONS
A prior section 300k, Pub. L. 93–641, § 2, Jan. 4, 1975, 88
Stat. 2226, set forth Congressional findings relating to
national health planning and development, prior to
omission in connection with repeal of former section
300k–1 et seq. of this title.
A prior section 1501 of act July 1, 1944, ch. 373, title
XV, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2227; amended Oct. 4, 1979, Pub. L. 96–79, title I,
§ 101(a)(1)(A), (2), (3), 93 Stat. 593; Dec. 17, 1980, Pub. L.
96–538, title III, § 301, 94 Stat. 3190, which related to
guidelines for national health policy, was classified to
section 300k–1 of this title, prior to repeal by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1, 1987.
Prior sections 300k–2 and 300k–3 were repealed by
Pub. L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat.
3799, effective Jan. 1, 1987.
Section 300k–2, act July 1, 1944, ch. 373, title XV,
§ 1502, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2227; amended Nov. 9, 1978, Pub. L. 95–619, title III,
§ 303(a), 92 Stat. 3248; Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 102(a), 103(a), (b), 93 Stat. 594, 595, related to national
health priorities and strengthening competition in supply of services.
Section 300k–3, act July 1, 1944, ch. 373, title XV,
§ 1503, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2228; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(a),
91 Stat. 384; July 10, 1979, Pub. L. 96–32, § 7(g), 93 Stat.
84; Oct. 4, 1979, Pub. L. 96–79, title I, § 102(b), 93 Stat. 594;
Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93 Stat. 695,
related to National Council on Health Planning and Development.
AMENDMENTS
2007—Subsec. (d). Pub. L. 110–18 substituted ‘‘2020’’ for
‘‘2000’’ in heading and ‘‘by the year 2020’’ for ‘‘by the
year 2000’’ in text.
1998—Subsec. (a)(2). Pub. L. 105–340, § 203(a), inserted
‘‘and support services such as case management’’ before
semicolon at end.
Subsec. (b)(1). Pub. L. 105–340, § 203(b)(1), substituted
‘‘through grants to public and nonprofit private entities and through contracts with public and private entities.’’ for ‘‘through grants to, and contracts with,
public or nonprofit private entities.’’
Subsec. (b)(2). Pub. L. 105–340, § 203(b)(2), added par. (2)
and struck out heading and text of former par. (2). Text
read as follows: ‘‘In addition to the authority established in paragraph (1) for a State with respect to
grants and contracts, the State may provide for screenings under subsection (a)(1) of this section through entering into contracts with private entities that are not
nonprofit entities.’’
Subsecs. (c), (d). Pub. L. 105–392 redesignated subsec.
(c), relating to coordinating committee regarding year
2000 health objectives, as (d).
1993—Subsec. (a). Pub. L. 103–183, § 101(g)(1), substituted ‘‘Control and Prevention’’ for ‘‘Control’’ in introductory provisions.
Subsec. (b). Pub. L. 103–183, § 101(a), substituted
‘‘paragraphs (2) and (3)’’ for ‘‘paragraph (2)’’ in par. (1),
added pars. (2) and (3), and struck out heading and text
of former par. (2). Text read as follows: ‘‘In addition to
the authority established in paragraph (1) for a State
with respect to grants and contracts, the State may
provide for screenings under subsection (a)(1) of this
section through entering into contracts with private
entities. The amount paid by a State to a private entity under the preceding sentence for a screening procedure may not exceed the amount that would be paid
under part B of title XVIII of the Social Security Act
if payment were made under such part for furnishing
the procedure to a woman enrolled under such part.’’
Pub. L. 103–43, § 2008(c)(1), designated existing provisions as par. (1), inserted par. heading, substituted
‘‘may, subject to paragraph (2), expend’’ for ‘‘may expend’’, and added par. (2).
Subsec. (c). Pub. L. 103–183, § 101(f), added subsec. (c)
relating to coordinating committee regarding year 2000
health objectives.

Page 1045

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 103–183, § 101(b), added subsec. (c) relating to
special consideration for certain States.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.

§ 300l. Requirement of matching funds
(a) In general
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees, with respect to the costs to be incurred by the State in carrying out the purpose
described in such section, to make available
non-Federal contributions (in cash or in kind
under subsection (b) of this section) toward such
costs in an amount equal to not less than $1 for
each $3 of Federal funds provided in the grant.
Such contributions may be made directly or
through donations from public or private entities.
(b) Determination of amount of non-Federal contribution
(1) In general
Non-Federal contributions required in subsection (a) of this section may be in cash or in
kind, fairly evaluated, including equipment or
services (and excluding indirect or overhead
costs). Amounts provided by the Federal Government, or services assisted or subsidized to
any significant extent by the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
(2) Maintenance of effort
In making a determination of the amount of
non-Federal contributions for purposes of subsection (a) of this section, the Secretary may
include only non-Federal contributions in excess of the average amount of non-Federal
contributions made by the State involved toward the purpose described in section 300k of
this title for the 2-year period preceding the
first fiscal year for which the State is applying to receive a grant under such section.
(3) Inclusion of relevant non-Federal contributions for medicaid
In making a determination of the amount of
non-Federal contributions for purposes of subsection (a) of this section, the Secretary shall,
subject to paragraphs (1) and (2) of this subsection, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] by the State
involved toward the purpose described in paragraphs (1) and (2) of section 300k(a) of this
title.
(July 1, 1944, ch. 373, title XV, § 1502, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 410.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(3),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Title XIX of the Social Security Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of
this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 300l, act July 1, 1944, ch. 373, title XV,
§ 1511, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.

§ 300l–1

2229; amended Apr. 22, 1976, Pub. L. 94–278, title XI,
§ 1106(a), 90 Stat. 416; Aug. 1, 1977, Pub. L. 95–83, title I,
§ 106(b), 91 Stat. 384; Oct. 4, 1979, Pub. L. 96–79, title I,
§ 104(a)(1), (b), 93 Stat. 595, 596, related to establishment
of health service areas, prior to repeal by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1, 1987.
A prior section 1502 of act July 1, 1944, ch. 373, title
XV, was classified to section 300k–2 of this title prior to
repeal by Pub. L. 99–660.

§ 300l–1. Requirement regarding medicaid
The Secretary may not make a grant under
section 300k of this title for a program in a
State unless the State plan under title XIX of
the Social Security Act [42 U.S.C. 1396 et seq.]
for the State includes the screening procedures
specified in subparagraphs (A) and (B) of section
300m(a)(2) of this title as medical assistance provided under the plan.
(July 1, 1944, ch. 373, title XV, § 1502A, as added
Pub. L. 102–531, title III, § 307, Oct. 27, 1992, 106
Stat. 3495.)
REFERENCES IN TEXT
The Social Security Act, referred to in text, is act
Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX
of the Act is classified generally to subchapter XIX
(§ 1396 et seq.) of chapter 7 of this title. For complete
classification of this Act to the Code, see section 1305
of this title and Tables.
PRIOR PROVISIONS
Prior sections 300l–1 to 300l–5 were repealed by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1, 1987.
Section 300l–1, act July 1, 1944, ch. 373, title XV, § 1512,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2232;
amended Mar. 19, 1976, Pub. L. 94–237, § 14(b), 90 Stat.
249; Oct. 12, 1976, Pub. L. 94–484, title IX, § 902(a), 90
Stat. 2324; Aug. 1, 1977, Pub. L. 95–83, title I, § 106(c), (d),
91 Stat. 384; Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 108(a)–(d)(1), (e), 109, 110(a)–(d)(1), (e)(1), (2)(A), (3),
111(a), (b), 112, 113(a), 114, 93 Stat. 601–607; Aug. 13, 1981,
Pub. L. 97–35, title IX, § 935(d), 95 Stat. 571; Oct. 22, 1986,
Pub. L. 99–514, § 2, 100 Stat. 2095, related to composition
and operation of health systems agencies.
Section 300l–2, act July 1, 1944, ch. 373, title XV, § 1513,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2235;
amended Mar. 19, 1976, Pub. L. 94–237, § 14(a), 90 Stat.
249; Aug. 1, 1977, Pub. L. 95–83, title I, § 106(e)–(i), 91
Stat. 384, 385; July 10, 1979, Pub. L. 96–32, § 7(m), 93 Stat.
84; Oct. 4, 1979, Pub. L. 96–79, title I, §§ 101(b)(1), 103(c),
107(a), 110(e)(4), (f), 115(b)(1), (2), (c)(2), (d)(1), (2), (e), (f),
(h), (i)(1), 118(a)(1), (b)(1), (c), 119(b), 120(a), 121, 122(a),
123(c)(1)(B), 93 Stat. 593, 595, 600, 604, 607–610, 620–625;
Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93 Stat. 695;
Jan. 2, 1980, Pub. L. 96–181, § 15(b), 93 Stat. 1316; Oct. 7,
1980, Pub. L. 96–398, title VIII, § 804(d), 94 Stat. 1608;
Aug. 13, 1981, Pub. L. 97–35, title IX, § 902(g)(4), 95 Stat.
561, related to functions of health systems agencies.
Section 300l–3, act July 1, 1944, ch. 373, title XV, § 1514,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2239;
amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(j), 91
Stat. 385; Oct. 4, 1979, Pub. L. 96–79, title I, § 105(f), 93
Stat. 598, provided for assistance to entities desiring to
be designated as health systems agencies.
Section 300l–4, act July 1, 1944, ch. 373, title XV, § 1515,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2239;
amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(k), 91
Stat. 385; Dec. 19, 1977, Pub. L. 95–215, § 6(a)(1), 91 Stat.
1507; Oct. 4, 1979, Pub. L. 96–79, title I, § 105(a)–(d)(1)(A),
(2), (e), (g), (h), 93 Stat. 596–598; Oct. 17, 1979, Pub. L.
96–88, title V, § 509(b), 93 Stat. 695, provided for designation of health systems agencies.
Section 300l–5, act July 1, 1944, ch. 373, title XV, § 1516,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2241;

§ 300m

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amended Aug. 1, 1977, Pub. L. 95–83, title I, § 102(a), 91
Stat. 383; Dec. 19, 1977, Pub. L. 95–215, § 6(a)(2), 91 Stat.
1507; Oct. 4, 1979, Pub. L. 96–79, title I, §§ 106, 107(b),
127(a), 93 Stat. 598, 600, 629; Dec. 17, 1980, Pub. L. 96–538,
title III, § 302, 94 Stat. 3190; Aug. 13, 1981, Pub. L. 97–35,
title IX, §§ 933(a)(1), 934(a), 95 Stat. 570, 571, provided for
planning grants to health systems agencies.

§ 300m. Requirements with respect to type and
quality of services
(a) Requirement of provision of all services by
date certain
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees—
(1) to ensure that, initially and throughout
the period during which amounts are received
pursuant to the grant, not less than 60 percent
of the grant is expended to provide each of the
services or activities described in paragraphs
(1) and (2) of section 300k(a) of this title, including making available screening procedures
for both breast and cervical cancers;
(2) subject to subsection (b) of this section,
to ensure that—
(A) in the case of breast cancer, both a
physical examination of the breasts and the
screening procedure known as a mammography are conducted; and
(B) in the case of cervical cancer, both a
pelvic examination and the screening procedure known as a pap smear are conducted;
(3) to ensure that, by the end of any second
fiscal year of payments pursuant to the grant,
each of the services or activities described in
section 300k(a) of this title is provided; and
(4) to ensure that not more than 40 percent
of the grant is expended to provide the services or activities described in paragraphs (3)
through (6) of such section.
(b) Use of improved screening procedures
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that, if any screening procedure
superior to a procedure described in subsection
(a)(2) of this section becomes commonly available and is recommended for use, any entity providing screening procedures pursuant to the
grant will utilize the superior procedure rather
than the procedure described in such subsection.
(c) Quality assurance regarding screening procedures
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that the State will, in accordance
with applicable law, assure the quality of
screening procedures conducted pursuant to
such section.
(d) Waiver of services requirement on division of
funds
(1) In general
The Secretary shall establish a demonstration project under which the Secretary may
waive the requirements of paragraphs (1) and
(4) of subsection (a) for not more than 5
States, if—
(A) the State involved will use the waiver
to leverage non-Federal funds to supplement

Page 1046

each of the services or activities described in
paragraphs (1) and (2) of section 300k(a) of
this title;
(B) the application of such requirement
would result in a barrier to the enrollment
of qualifying women;
(C) the State involved—
(i) demonstrates, to the satisfaction of
the Secretary, the manner in which the
State will use such waiver to expand the
level of screening and follow-up services
provided immediately prior to the date on
which the waiver is granted; and
(ii) provides assurances, satisfactory to
the Secretary, that the State will, on an
annual basis, demonstrate, through such
documentation as the Secretary may require, that the State has used such waiver
as described in clause (i);
(D) the State involved submits to the Secretary—
(i) assurances, satisfactory to the Secretary, that the State will maintain the
average annual level of State fiscal year
expenditures for the services and activities
described in paragraphs (1) and (2) of section 300k(a) of this title for the period for
which the waiver is granted, and for the
period for which any extension of such
wavier is granted, at a level that is not
less than—
(I) the level of the State fiscal year expenditures for such services and activities for the fiscal year preceding the first
fiscal year for which the waiver is granted; or
(II) at the option of the State and upon
approval by the Secretary, the average
level of the State expenditures for such
services and activities for the 3-fiscal
year period preceding the first fiscal
year for which the waiver is granted; and
(ii) a plan, satisfactory to the Secretary,
for maintaining the level of activities carried out under the waiver after the expiration of the waiver and any extension of
such waiver;
(E) the Secretary finds that granting such
a waiver to a State will increase the number
of women in the State that receive each of
the services or activities described in paragraphs (1) and (2) of section 300k(a) of this
title, including making available screening
procedures for both breast and cervical cancers; and
(F) the Secretary finds that granting such
a waiver to a State will not adversely affect
the quality of each of the services or activities described in paragraphs (1) and (2) of
section 300k(a) of this title.
(2) Duration of waiver
(A) In general
In granting waivers under paragraph (1),
the Secretary—
(i) shall grant such waivers for a period
that is not less than 1 year but not more
than 2 years; and
(ii) upon request of a State, may extend
a waiver for an additional period that is

Page 1047

TITLE 42—THE PUBLIC HEALTH AND WELFARE

not less than 1 year but not more than 2
years in accordance with subparagraph (B).
(B) Additional period
The Secretary, upon the request of a State
that has received a waiver under paragraph
(1), shall, at the end of the waiver period described in subparagraph (A)(i), review performance under the waiver and may extend
the waiver for an additional period if the
Secretary determines that—
(i) without an extension of the waiver,
there will be a barrier to the enrollment of
qualifying women;
(ii) the State requesting such extended
waiver will use the waiver to leverage nonFederal funds to supplement the services
or activities described in paragraphs (1)
and (2) of section 300k(a) of this title;
(iii) the waiver has increased, and will
continue to increase, the number of
women in the State that receive the services or activities described in paragraphs
(1) and (2) of section 300k(a) of this title;
(iv) the waiver has not, and will not, result in lower quality in the State of the
services or activities described in paragraphs (1) and (2) of section 300k(a) of this
title; and
(v) the State has maintained the average
annual level of State fiscal expenditures
for the services and activities described in
paragraphs (1) and (2) of section 300k(a) of
this title for the period for which the waiver was granted at a level that is not less
than—
(I) the level of the State fiscal year expenditures for such services and activities for the fiscal year preceding the first
fiscal year for which the waiver is granted; or
(II) at the option of the State and upon
approval by the Secretary, the average
level of the State expenditures for such
services and activities for the 3-fiscal
year period preceding the first fiscal
year for which the waiver is granted.
(3) Reporting requirements
The Secretary shall include as part of the
evaluations and reports required under section
300n–4 of this title, the following:
(A) A description of the total amount of
dollars leveraged annually from Non-Federal 1 entities in States receiving a waiver
under paragraph (1) and how these amounts
were used.
(B) With respect to States receiving a
waiver under paragraph (1), a description of
the percentage of the grant that is expended
on providing each of the services or activities described in—
(i) paragraphs (1) and (2) of section
300k(a) of this title; and
(ii) paragraphs (3) through (6) of section
300k(a) of this title.
(C) A description of the number of States
receiving waivers under paragraph (1) annually.
1 So

in original. Probably should be ‘‘non-Federal’’.

§ 300m

(D) With respect to States receiving a
waiver under paragraph (1), a description
of—
(i) the number of women receiving services under paragraphs (1), (2), and (3) of
section 300k(a) of this title in programs before and after the granting of such waiver;
and
(ii) the average annual level of State fiscal expenditures for the services and activities described in paragraphs (1) and (2)
of section 300k(a) of this title for the year
preceding the first year for which the
waiver was granted.
(4) Limitation
Amounts to which a waiver applies under
this subsection shall not be used to increase
the number of salaried employees.
(5) Definitions
In this subsection:
(A) Indian tribe
The term ‘‘Indian tribe’’ has the meaning
given the term in section 1603 of title 25.
(B) Tribal organization
The term ‘‘tribal organization’’ has the
meaning given the term in section 1603 of
title 25.
(C) State
The term ‘‘State’’ means each of the several States of the United States, the District
of Columbia, the Commonwealth of Puerto
Rico, American Samoa, the Commonwealth
of the Northern Mariana Islands, the Republic of the Marshall Islands, the Federated
States of Micronesia, the Republic of Palau,
an Indian tribe, and a tribal organization.
(6) Sunset
The Secretary may not grant a waiver or extension under this subsection after September
30, 2012.
(July 1, 1944, ch. 373, title XV, § 1503, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 410;
amended Pub. L. 103–183, title I, § 101(c)(1), Dec.
14, 1993, 107 Stat. 2227; Pub. L. 110–18, § 2(2), Apr.
20, 2007, 121 Stat. 80.)
PRIOR PROVISIONS
Prior sections 300m to 300m–6 were repealed by Pub.
L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799,
effective Jan. 1, 1987.
Section 300m, act July 1, 1944, ch. 373, title XV, § 1521,
as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat. 2242;
amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(l), (m),
91 Stat. 385; Dec. 19, 1977, Pub. L. 95–215, § 6(b), 91 Stat.
1507; July 16, 1979, Pub. L. 96–33, 93 Stat. 86; Oct. 4, 1979,
Pub. L. 96–79, title I, § 123(a), (b)(1)(A), (2), (d), (f), (g)(2),
93 Stat. 624–627; Oct. 17, 1979, Pub. L. 96–88, title V,
§ 509(b), 93 Stat. 695; Jan. 2, 1980, Pub. L. 96–181, § 15(b),
93 Stat. 1316; Dec. 17, 1980, Pub. L. 96–538, title III,
§ 303(b), 94 Stat. 3190; Aug. 13, 1981, Pub. L. 97–35, title
IX, §§ 902(g)(5), 936(b), 95 Stat. 561, 572; Jan. 4, 1983, Pub.
L. 97–414, § 9(b), 96 Stat. 2064, provided for designation of
State health planning and development agencies.
A prior section 1503 of act July 1, 1944, ch. 373, title
XV, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2228; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(a),
91 Stat. 384; July 10, 1979, Pub. L. 96–32, § 7(g), 93 Stat.
84; Oct. 4, 1979, Pub. L. 96–79, title I, § 102(b), 93 Stat. 594;
Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b), 93 Stat. 695,

§ 300n

TITLE 42—THE PUBLIC HEALTH AND WELFARE

which related to National Council on Health Planning
and Development, was classified to section 300k–3 of
this title.
Section 300m–1, act July 1, 1944, ch. 373, title XV,
§ 1522, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2244; amended 1978 Reorg. Plan No. 2, § 102, eff. Jan. 1,
1979, 43 F.R. 36037, 92 Stat. 3783; Oct. 4, 1979, Pub. L.
96–79, title I, §§ 101(b)(2), 111(c), 115(b)(3), 117(b)(4), 120(b),
122(b), 123(c)(1)(A), (e)(1), 93 Stat. 594, 605, 607, 620, 622,
624, 625, 626; Oct. 17, 1979, Pub. L. 96–88, title V, § 509(b),
93 Stat. 695, related to State administrative programs.
Section 300m–2, act July 1, 1944, ch. 373, title XV,
§ 1523, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2246; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(n),
91 Stat. 385; Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 115(c)(1)(A)–(C), (i)(2), 117(b)(1), (2), 118(a)(2), (b)(2),
123(c)(2), (3), (e)(2), (g)(1), 93 Stat. 607, 608, 610, 618, 619,
621, 625–627; Oct. 7, 1980, Pub. L. 96–398, title III, § 303, 94
Stat. 1588, related to State health planning and development functions.
Section 300m–3, act July 1, 1944, ch. 373, title XV,
§ 1524, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2247; amended Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 110(d)(2), 113(b), 115(a), (c)(1)(D), (d)(3), (g), (i)(2)–(4),
119(a), 124, 93 Stat. 604, 606–610, 621, 627; Jan. 2, 1980, Pub.
L. 96–181, § 15(b), 93 Stat. 1316; Dec. 17, 1980, Pub. L.
96–538, title III, §§ 304, 305, 94 Stat. 3191; Aug. 13, 1981,
Pub. L. 97–35, title IX, § 902(g)(6), 95 Stat. 561, related to
composition and functions of Statewide Health Coordinating Councils.
Section 300m–4, act July 1, 1944, ch. 373, title XV,
§ 1525, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2249; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 102(b),
91 Stat. 383; Oct. 4, 1979, Pub. L. 96–79, title I, §§ 107(c),
127(b), 93 Stat. 600, 629; Aug. 13, 1981, Pub. L. 97–35, title
IX, § 933(a)(2), 95 Stat. 570, provided for grants for State
health planning and development.
Section 300m–5, act July 1, 1944, ch. 373, title XV,
§ 1526, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2249; amended Aug. 1, 1977, Pub. L. 95–83, title I,
§§ 102(c), 106(o), 91 Stat. 383, 385; Oct. 4, 1979, Pub. L.
96–79, title I, §§ 107(d), 120(c), 127(c), 93 Stat. 600, 622, 629,
provided for grants for rate regulation.
Section 300m–6, act July 1, 1944, ch. 373, title XV,
§ 1527, as added Oct. 4, 1979, Pub. L. 96–79, title I, § 117(a),
93 Stat. 614; amended Dec. 17, 1980, Pub. L. 96–538, title
III, §§ 306, 307, 94 Stat. 3191; Aug. 13, 1981, Pub. L. 97–35,
title IX, § 949(c), 95 Stat. 578, related to certificate of
need program.
AMENDMENTS
2007—Subsec. (d). Pub. L. 110–18 added subsec. (d).
1993—Subsecs. (c) to (e). Pub. L. 103–183 added subsec.
(c) and struck out former subsecs. (c) which related to
quality assurance regarding screening for breast cancer, (d) which related to quality assurance regarding
screening for cervical cancer, and (e) which related to
issuance by Secretary of guidelines with respect to
quality of mammography and cytological services.
TRANSITION RULE REGARDING MAMMOGRAPHIES
Section 101(c)(2) of Pub. L. 103–183 provided that:
‘‘With respect to the screening procedure for breast
cancer known as a mammography, the requirements in
effect on the day before the date of the enactment of
this Act [Dec. 14, 1993] under section 1503(c) of the Public Health Service Act [subsec. (c) of this section] remain in effect (for an individual or facility conducting
such procedures pursuant to a grant to a State under
section 1501 of such Act [section 300k of this title])
until there is in effect for the facility a certificate (or
provisional certificate) issued under section 354 of such
Act [section 263b of this title].’’

§ 300n. Additional required agreements
(a) Priority for low-income women
The Secretary may not make a grant under
section 300k of this title unless the State in-

Page 1048

volved agrees that low-income women will be
given priority in the provision of services and
activities pursuant to paragraphs (1) and (2) of
section 300k(a) of this title.
(b) Limitation on imposition of fees for services
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that, if a charge is imposed for the
provision of services or activities under the
grant, such charge—
(1) will be made according to a schedule of
charges that is made available to the public;
(2) will be adjusted to reflect the income of
the woman involved; and
(3) will not be imposed on any woman with
an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget
and revised by the Secretary in accordance
with section 9902(2) of this title.
(c) Statewide provision of services
(1) In general
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that services and activities
under the grant will be made available
throughout the State, including availability
to members of any Indian tribe or tribal organization (as such terms are defined in section
450b of title 25).
(2) Waiver
The Secretary may waive the requirement
established in paragraph (1) for a State if the
Secretary determines that compliance by the
State with the requirement would result in an
inefficient allocation of resources with respect
to carrying out the purpose described in section 300k(a) of this title.
(3) Grants to tribes and tribal organizations
(A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to tribes and tribal
organizations (as such terms are used in paragraph (1)) for the purpose of carrying out programs described in section 300k(a) of this title.
This subchapter applies to such a grant (in relation to the jurisdiction of the tribe or organization) to the same extent and in the same
manner as such subchapter applies to a grant
to a State under section 300k of this title (in
relation to the jurisdiction of the State).
(B) If a tribe or tribal organization is receiving a grant under subparagraph (A) and the
State in which the tribe or organization is located is receiving a grant under section 300k of
this title, the requirement established in paragraph (1) for the State regarding the tribe or
organization is deemed to have been waived
under paragraph (2).
(d) Relationship to items and services under
other programs
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that the grant will not be expended to make payment for any item or service
to the extent that payment has been made, or
can reasonably be expected to be made, with respect to such item or service—

Page 1049

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) under any State compensation program,
under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services
on a prepaid basis.
(e) Coordination with other breast and cervical
cancer programs
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that the services and activities
funded through the grant shall be coordinated
with other Federal, State, and local breast and
cervical cancer programs.
(f) Limitation on administrative expenses
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that not more than 10 percent of
the grant will be expended for administrative
expenses with respect to the grant.
(g) Restrictions on use of grant
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that the grant will not be expended to provide inpatient hospital services for
any individual.
(h) Records and audits
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees that—
(1) the State will establish such fiscal control and fund accounting procedures as may be
necessary to ensure the proper disbursal of,
and accounting for, amounts received by the
State under such section; and
(2) upon request, the State will provide
records maintained pursuant to paragraph (1)
to the Secretary or the Comptroller of the
United States for purposes of auditing the expenditures by the State of the grant.
(i) Reports to Secretary
The Secretary may not make a grant under
section 300k of this title unless the State involved agrees to submit to the Secretary such
reports as the Secretary may require with respect to the grant.
(July 1, 1944, ch. 373, title XV, § 1504, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 412;
amended Pub. L. 103–183, title I, § 101(d), Dec. 14,
1993, 107 Stat. 2228.)
PRIOR PROVISIONS
A prior section 300n, act July 1, 1944, ch. 373, title XV,
§ 1531, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2250; amended Mar. 19, 1976, Pub. L. 94–237, § 14(c), 90
Stat. 249; Oct. 12, 1976, Pub. L. 94–484, title IX, § 902(b),
90 Stat. 2324; Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 104(c)(2), 108(d)(2), 117(b)(3), 126(a)(1), (b), 93 Stat. 596,
602, 619, 628; Dec. 17, 1980, Pub. L. 96–538, title III, §§ 308,
309, 94 Stat. 3192; Aug. 13, 1981, Pub. L. 97–35, title IX,
§ 936(a), 95 Stat. 572, defined terms applicable to this
subchapter, prior to repeal by Pub. L. 99–660, title VII,
§ 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1,
1987.

§ 300n–2

(1) the State involved submits to the Secretary a description of the purposes for which
the State intends to expend the grant;
(2) the description identifies the populations,
areas, and localities in the State with a need
for the services or activities described in section 300k(a) of this title;
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in
which the services and activities will be coordinated with any similar services or activities
of public and private entities; and
(4) the description provides assurances that
the grant funds will be used in the most costeffective manner.
(July 1, 1944, ch. 373, title XV, § 1505, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 414;
amended Pub. L. 103–43, title XX, § 2008(c)(2),
June 10, 1993, 107 Stat. 211; Pub. L. 103–183, title
I, § 101(g)(2), Dec. 14, 1993, 107 Stat. 2229; Pub. L.
105–392, title IV, § 401(b)(6), Nov. 13, 1998, 112 Stat.
3587.)
PRIOR PROVISIONS
A prior section 300n–1, act July 1, 1944, ch. 373, title
XV, § 1532, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88
Stat. 2251; amended Oct. 8, 1976, Pub. L. 94–460, title I,
§ 117(a), 90 Stat. 1954; Nov. 9, 1978, Pub. L. 95–619, title
III, § 303(b), (c), 92 Stat. 3248; Oct. 4, 1979, Pub. L. 96–79,
title I, §§ 103(d), 116, 117(b)(5), 93 Stat. 595, 610, 620; Dec.
17, 1980, Pub. L. 96–538, title III, § 310, 94 Stat. 3192, provided for procedures and criteria for review of proposed
health system changes, prior to repeal by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1, 1987.
AMENDMENTS
1998—Par. (3). Pub. L. 105–392 struck out ‘‘nonprofit’’
before ‘‘private entities’’.
1993—Par. (3). Pub. L. 103–183, § 101(g)(2)(A), substituted ‘‘public and nonprofit private entities; and’’
for ‘‘public or nonprivate entities (and additionally, in
the case of services and activities under section
300k(a)(1) of this title, with any similar services or activities of private entities); and’’.
Pub. L. 103–43 inserted before semicolon ‘‘(and additionally, in the case of services and activities under
section 300k(a)(1) of this title, with any similar services
or activities of private entities)’’.
Par. (4). Pub. L. 103–183, § 101(g)(2)(B), inserted ‘‘will’’
after ‘‘grant funds’’.
EFFECTIVE DATE OF 1998 AMENDMENT
Amendment by Pub. L. 105–392 deemed to have taken
effect immediately after enactment of Pub. L. 103–183,
see section 401(e) of Pub. L. 105–392, set out as a note
under section 242m of this title.

§ 300n–2. Requirement of submission of application

§ 300n–1. Description of intended uses of grant

The Secretary may not make a grant under
section 300k of this title unless an application
for the grant is submitted to the Secretary, the
application contains the description of intended
uses required in section 300n–1 of this title, and
the application is in such form, is made in such
manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subchapter.

The Secretary may not make a grant under
section 300k of this title unless—

(July 1, 1944, ch. 373, title XV, § 1506, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 414.)

AMENDMENTS
1993—Subsec. (c)(3). Pub. L. 103–183 added par. (3).

§ 300n–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 300n–2, act July 1, 1944, ch. 373, title
XV, § 1533, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88
Stat. 2253, provided for technical assistance to health
systems agencies and State agencies, prior to repeal by
Pub. L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat.
3799, effective Jan. 1, 1987.

§ 300n–3. Technical assistance and provision of
supplies and services in lieu of grant funds
(a) Technical assistance
The Secretary may provide training and technical assistance with respect to the planning,
development, and operation of any program or
service carried out pursuant to section 300k of
this title. The Secretary may provide such technical assistance directly or through grants to, or
contracts with, public and private entities.
(b) Provision of supplies and services in lieu of
grant funds
(1) In general
Upon the request of a State receiving a
grant under section 300k of this title, the Secretary may, subject to paragraph (2), provide
supplies, equipment, and services for the purpose of aiding the State in carrying out such
section and, for such purpose, may detail to
the State any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the
amount of payments under the grant under
section 300k of this title to the State involved
by an amount equal to the costs of detailing
personnel (including pay, allowances, and
travel expenses) and the fair market value of
any supplies, equipment, or services provided
by the Secretary. The Secretary shall, for the
payment of expenses incurred in complying
with such request, expend the amounts withheld.
(July 1, 1944, ch. 373, title XV, § 1507, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 414.)
PRIOR PROVISIONS
A prior section 300n–3, act July 1, 1944, ch. 373, title
XV, § 1534, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88
Stat. 2255; amended Aug. 1, 1977, Pub. L. 95–83, title I,
§ 102(d), 91 Stat. 383; Oct. 4, 1979, Pub. L. 96–79, title I,
§§ 125, 127(d), 93 Stat. 628, 629; Aug. 13, 1981, Pub. L. 97–35,
title IX, § 933(a)(3), 95 Stat. 570, provided for developing
new centers for health planning, prior to repeal by Pub.
L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799,
effective Jan. 1, 1987.

§ 300n–4. Evaluations and reports
(a) Evaluations
The Secretary shall, directly or through contracts with public or private entities, provide
for annual evaluations of programs carried out
pursuant to section 300k of this title. Such evaluations shall include evaluations of—
(1) the extent to which States carrying out
such programs are in compliance with section
300k(a)(2) of this title and with section 300n(c)
of this title; and
(2) the extent to which each State receiving
a grant under this subchapter is in compliance

Page 1050

with section 300l of this title, including identification of—
(A) the amount of the non-Federal contributions by the State for the preceding fiscal year, disaggregated according to the
source of the contributions; and
(B) the proportion of such amount of nonFederal contributions relative to the
amount of Federal funds provided through
the grant to the State for the preceding fiscal year.
(b) Report to Congress
The Secretary shall, not later than 1 year
after April 20, 2007,1 and annually thereafter,
submit to the Committee on Energy and Commerce of the House of Representatives, and to
the Committee on Labor and Human Resources
of the Senate, a report summarizing evaluations
carried out pursuant to subsection (a) of this
section during the preceding fiscal year and
making such recommendations for administrative and legislative initiatives with respect to
this subchapter as the Secretary determines to
be appropriate, including recommendations regarding compliance by the States with section
300k(a)(2) of this title and with section 300n(c) of
this title.
(July 1, 1944, ch. 373, title XV, § 1508, as added
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 415;
amended Pub. L. 103–183, title I, § 101(e), Dec. 14,
1993, 107 Stat. 2228; Pub. L. 110–18, § 2(3), Apr. 20,
2007, 121 Stat. 83.)
REFERENCES IN TEXT
April 20, 2007, referred to in subsec. (b), was in the
original ‘‘the date of the enactment of the National
Breast and Cervical Cancer Early Detection Program
Reauthorization of 2007’’, and was translated as reading
‘‘the date of the enactment of the National Breast and
Cervical Cancer Early Detection Program Reauthorization Act of 2007’’, to reflect the probable intent of Congress.
PRIOR PROVISIONS
A prior section 300n–4, act July 1, 1944, ch. 373, title
XV, § 1535, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88
Stat. 2256, provided for review by Secretary of operations of designated health systems agencies and State
agencies, prior to repeal by Pub. L. 99–660, title VII,
§ 701(a), Nov. 14, 1986, 100 Stat. 3799, effective Jan. 1,
1987.
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–18, § 2(3)(A), substituted
‘‘evaluations of—’’ and pars. (1) and (2) for ‘‘evaluations
of the extent to which States carrying out such programs are in compliance with section 300k(a)(2) of this
title and with section 300n(c) of this title.’’
Subsec. (b). Pub. L. 110–18, § 2(3)(B), substituted ‘‘not
later than 1 year after April 20, 2007, and annually
thereafter’’ for ‘‘not later than 1 year after the date on
which amounts are first appropriated pursuant to section 300n–5(a) of this title, and annually thereafter’’.
1993—Subsec. (a). Pub. L. 103–183, § 101(e)(1), inserted
at end ‘‘Such evaluations shall include evaluations of
the extent to which States carrying out such programs
are in compliance with section 300k(a)(2) of this title
and with section 300n(c) of this title.’’
Subsec. (b). Pub. L. 103–183, § 101(e)(2), inserted before
period at end ‘‘, including recommendations regarding
compliance by the States with section 300k(a)(2) of this
title and with section 300n(c) of this title’’.
1 See

References in Text note below.

Page 1051

TITLE 42—THE PUBLIC HEALTH AND WELFARE
CHANGE OF NAME

Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 300n–4a. Supplemental grants for additional
preventive health services
(a) Demonstration projects
In the case of States receiving grants under
section 300k of this title, the Secretary, acting
through the Director of the Centers for Disease
Control and Prevention, may make grants to
not more than 3 such States to carry out demonstration projects for the purpose of—
(1) providing preventive health services in
addition to the services authorized in such
section, including screenings regarding blood
pressure and cholesterol, and including health
education;
(2) providing appropriate referrals for medical treatment of women receiving services
pursuant to paragraph (1) and ensuring, to the
extent practicable, the provision of appropriate follow-up services; and
(3) evaluating activities conducted under
paragraphs (1) and (2) through appropriate surveillance or program-monitoring activities.
(b) Status as participant in program regarding
breast and cervical cancer
The Secretary may not make a grant under
subsection (a) of this section unless the State
involved agrees that services under the grant
will be provided only through entities that are
screening women for breast or cervical cancer
pursuant to a grant under section 300k of this
title.
(c) Applicability of provisions of general program
This subchapter applies to a grant under subsection (a) of this section to the same extent
and in the same manner as such subchapter applies to a grant under section 300k of this title.
(d) Funding
(1) In general
Subject to paragraph (2), for the purpose of
carrying out this section, there are authorized
to be appropriated $3,000,000 for fiscal year
1994, and such sums as may be necessary for
each of the fiscal years 1995 through 2003.
(2) Limitation regarding funding with respect
to breast and cervical cancer
The authorization of appropriations established in paragraph (1) is not effective for a fiscal year unless the amount appropriated under
section 300n–5(a) of this title for the fiscal
year is equal to or greater than $100,000,000.

§ 300n–5

(July 1, 1944, ch. 373, title XV, § 1509, as added
Pub. L. 103–183, title I, § 102(a)(2), Dec. 14, 1993,
107 Stat. 2229; amended Pub. L. 105–340, title II,
§ 203(c)(1), Oct. 31, 1998, 112 Stat. 3194.)
PRIOR PROVISIONS
A prior section 1509 of act July 1, 1944, was renumbered section 1510 and is classified to section 300n–5 of
this title.
AMENDMENTS
1998—Subsec. (d)(1). Pub. L. 105–340 substituted ‘‘2003’’
for ‘‘1998’’.

§ 300n–5. Funding for general program
(a) Authorization of appropriations
For the purpose of carrying out this subchapter, there are authorized to be appropriated
$50,000,000 for fiscal year 1991, such sums as may
be necessary for each of the fiscal years 1992 and
1993, $150,000,000 for fiscal year 1994, such sums as
may be necessary for each of the fiscal years
1995 through 2003, $225,000,000 for fiscal year 2008,
$245,000,000 for fiscal year 2009, $250,000,000 for
fiscal year 2010, $255,000,000 for fiscal year 2011,
and $275,000,000 for fiscal year 2012.
(b) Set-aside for technical assistance and provision of supplies and services
Of the amounts appropriated under subsection
(a) of this section for a fiscal year, the Secretary
shall reserve not more than 20 percent for carrying out section 300n–3 of this title.
(July 1, 1944, ch. 373, title XV, § 1510, formerly
§ 1509, as added Pub. L. 101–354, § 2, Aug. 10, 1990,
104 Stat. 415; renumbered § 1510 and amended
Pub. L. 103–183, title I, §§ 102(a)(1), (b), 103, Dec.
14, 1993, 107 Stat. 2229, 2230; Pub. L. 105–340, title
II, § 203(c)(2), Oct. 31, 1998, 112 Stat. 3194; Pub. L.
110–18, § 2(4), Apr. 20, 2007, 121 Stat. 83.)
PRIOR PROVISIONS
Prior sections 300n–5 and 300n–6 were repealed by Pub.
L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799,
effective Jan. 1, 1987.
Section 300n–5, act July 1, 1944, ch. 373, title XV,
§ 1536, as added Jan. 4, 1975, Pub. L. 93–641, § 3, 88 Stat.
2257; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(p),
(q), 91 Stat. 385; Oct. 4, 1979, Pub. L. 96–79, title I,
§ 104(c)(1), 93 Stat. 596; Aug. 13, 1981, Pub. L. 97–35, title
IX, § 935(a), 95 Stat. 571; Jan. 4, 1983, Pub. L. 97–414,
§ 8(p), 96 Stat. 2062, made special provisions for certain
States and territories.
Section 300n–6, act July 1, 1944, ch. 373, title XV,
§ 1537, as added Aug. 13, 1981, Pub. L. 97–35, title IX,
§ 933(b), 95 Stat. 570, authorized appropriations for
grants and contracts under former sections 300l–5(a),
300m–4(a), and 300n–3(a) of this title.
AMENDMENTS
2007—Subsec. (a). Pub. L. 110–18 struck out ‘‘and’’
after ‘‘$150,000,000 for fiscal year 1994,’’ and inserted before period at end ‘‘, $225,000,000 for fiscal year 2008,
$245,000,000 for fiscal year 2009, $250,000,000 for fiscal
year 2010, $255,000,000 for fiscal year 2011, and
$275,000,000 for fiscal year 2012’’.
1998—Subsec. (a). Pub. L. 105–340 substituted ‘‘2003’’
for ‘‘1998’’.
1993—Pub. L. 103–183, § 102(b), inserted ‘‘for general
program’’ after ‘‘Funding’’ in section catchline.
Subsec. (a). Pub. L. 103–183, § 103, struck out ‘‘and’’
after ‘‘1991,’’ and inserted before period at end
‘‘, $150,000,000 for fiscal year 1994, and such sums as may
be necessary for each of the fiscal years 1995 through
1998’’.

§§ 300o to 300o–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

SUBCHAPTER XIV—HEALTH RESOURCES
DEVELOPMENT
§§ 300o to 300o–3. Repealed. Pub. L. 96–79, title II,
§ 202(a), Oct. 4, 1979, 93 Stat. 632
Sections 300o to 300o–3, act July 1, 1944, ch. 373, title
XVI, §§ 1601–1604, as added Jan. 4, 1975, Pub. L. 93–641, § 4,
88 Stat. 2258–2260; amended Aug. 1, 1977, Pub. L. 95–83,
title I, § 106(r)–(v), 91 Stat. 385, were repealed by Pub. L.
96–79, title II, § 202(a), Oct. 4, 1979, 93 Stat. 632.
Section 300o related to statement of purpose.
Section 300o–1 provided for promulgation of regulations and required provisions.
Section 300o–2 related to State medical facilities
plans, submission and approval of plans as prerequisite
for approval of project assistance applications, required
provisions, and procedure upon disapproval of plans.
Section 300o–3 provided for medical facility project
applications, covering in submission of applications, required provisions, waivers, and projects subject to requirements, criteria for approval, procedure for disapproval, amendment of approved applications, and review by health systems agencies.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1979, see section 204 of Pub. L.
96–79, set out as an Effective Date of 1979 Amendment
note under section 300q of this title.

§§ 300p to 300p–3. Repealed. Pub. L. 96–79, title II,
§ 201(a), Oct. 4, 1979, 93 Stat. 630
Sections 300p to 300p–3, act July 1, 1944, ch. 373, title
XVI, §§ 1610–1613, as added Jan. 4, 1975, Pub. L. 93–641, § 4,
88 Stat. 2262–2264; amended Apr. 22, 1976, Pub. L. 94–278,
title XI, § 1106(b), 90 Stat. 416; Aug. 1, 1977, Pub. L. 95–83,
title I, §§ 103(a), 106(w), 91 Stat. 383, 385, were repealed
by Pub. L. 96–79, title II, § 201(a), Oct. 4, 1979, 93 Stat.
632.
Section 300p related to allotments to States for
health resources development.
Section 300p–1 related to payments to States for approved medical facility projects.
Section 300p–2 related to compliance provisions and
withholding of payments for noncompliance.
Section 300p–3 authorized appropriations for allotments to States.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1979, see section 204 of Pub. L.
96–79, set out as an Effective Date of 1979 Amendment
note under section 300q of this title.

PART A—LOANS AND LOAN GUARANTEES
AMENDMENTS
1979—Pub. L. 96–79, title II, § 202(a), Oct. 4, 1979, 93
Stat. 632, repealed part A relating to purpose, State
plan, and project approval, and comprising former sections 300o to 300o–3 of this title, and redesignated
former part C as part A relating to loans and loan guarantees.

§ 300q. Loan and loan guarantee authority
(a) Covered projects: duration; payment of principal and interest on loans for covered
projects: duration; payments for reduction of
interest rate
(1) The Secretary, during the period ending
September 30, 1982, may, in accordance with this
part, make loans from the fund established
under section 300q–2(d) of this title to any public
or nonprofit private entity for projects for—
(A) the discontinuance of unneeded hospital
services or facilities,1
1 So

in original. The comma probably should be a semicolon.

Page 1052

(B) the conversion of unneeded hospital services and facilities to needed health services
and medical facilities, including outpatient
medical facilities and facilities for long-term
care;
(C) the renovation and modernization of
medical facilities, particularly projects for the
prevention or elimination of safety hazards,
projects to avoid noncompliance with licensure or accreditation standards, or projects to
replace obsolete facilities;
(D) the construction of new outpatient medical facilities; and
(E) the construction of new inpatient medical facilities in areas which have experienced
(as determined by the Secretary) recent rapid
population growth.
(2)(A) The Secretary, during the period ending
September 30, 1982, may, in accordance with this
part, guarantee to—
(i) non-Federal lenders for their loans to
public and nonprofit private entities for medical facilities projects described in paragraph
(1), and
(ii) the Federal Financing Bank for its loans
to public and nonprofit private entities for
such projects,
payment of principal and interest on such loans.
(B) In the case of a guarantee of any loan to
a public or nonprofit private entity under subparagraph (A)(i) which is located in an urban or
rural poverty area, the Secretary may pay, to
the holder of such loan and for and on behalf of
the project for which the loan was made,
amounts sufficient to reduce by not more than
one half the net effective interest rate otherwise
payable on such loan if the Secretary finds that
without such assistance the project could not be
undertaken.
(b) Amount of loans for medical facilities
projects and such projects in urban or rural
poverty areas
The principal amount of a loan directly made
or guaranteed under subsection (a) of this section for a medical facilities project, when added
to any other assistance provided such project
under part B, may not exceed 90 per centum of
the cost of such project unless the project is located in an area determined by the Secretary to
be an urban or rural poverty area, in which case
the principal amount, when added to other assistance under part B, may cover up to 100 per
centum of such costs.
(c) Limitation on cumulative total of principal of
outstanding loans
The cumulative total of the principal of the
loans outstanding at any time with respect to
which guarantees have been issued, or which
have been directly made, may not exceed such
limitations as may be specified in appropriation
Acts.
(d) Administrative assistance of Department of
Housing and Urban Development
The Secretary, with the consent of the Secretary of Housing and Urban Development, shall
obtain from the Department of Housing and
Urban Development such assistance with respect
to the administration of this part as will promote efficiency and economy thereof.

Page 1053

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XVI, § 1601, formerly
§ 1620, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2264; amended Pub. L. 94–273, § 2(21), Apr.
21, 1976, 90 Stat. 376; Pub. L. 95–83, title I,
§ 106(x)(1), Aug. 1, 1977, 91 Stat. 385; renumbered
§ 1601 and amended Pub. L. 96–79, title II,
§§ 201(b)(1), 203(a)(1), (2), Oct. 4, 1979, 93 Stat. 630,
635.)
PRIOR PROVISIONS
A prior section 1601 of act July 1, 1944, ch. 373, title
XVI, as added Jan. 4, 1975, Pub. L. 93–641, § 4, 88 Stat.
2258, was classified to section 300o of this title, prior to
repeal by Pub. L. 96–79, § 202(a).
AMENDMENTS
1979—Subsec. (a). Pub. L. 96–79, §§ 201(b)(1), 203(a)(2),
added par. (1); substituted reference to section 1602(d)
for 1622(d), set out in text as ‘‘section 300q–2(d) of this
title’’; incorporated in par. (2) former subsec. (b) provisions made applicable for period ending Sept. 30, 1982,
previously covering period beginning July 1, 1974, and
ending Sept. 30, 1978, extended provisions to public entities, struck out existing condition that applications for
assistance under subchapter be approved under former
section 300o–3 of this title, substituted in subpar. (2)(B)
provision for payment of amounts sufficient to reduce
by not more than one half net effective interest otherwise payable on the loan for prior provision for
amounts sufficient to reduce by 3 per centum per
annum net effective interest rate on the loan, and
struck out provision granting contractual right of
holder of a guaranteed loan to receive from the United
States such interest payments.
Subsec. (b). Pub. L. 96–79, § 201(b)(1), added subsec. (b)
and incorporated existing provisions of subsec. (b) relating to loan guarantee authority for payment of principal and interest on loans for approved projects, their
duration, and payments for reduction of interest rate
in subsec. (a)(2) of this section.
1977—Subsecs. (a), (b)(1). Pub. L. 95–83 substituted
‘‘September 30, 1978’’ for ‘‘September 30, 1977’’.
1976—Subsecs. (a), (b)(1). Pub. L. 94–273 substituted
‘‘September’’ for ‘‘June’’.
EFFECTIVE DATE OF 1979 AMENDMENT
Section 204 of Pub. L. 96–79 provided that: ‘‘The
amendments made by this title [enacting sections 300s,
300s–1, and 300s–6, amending this section and sections
201, 300q–2, 300r, 300s–1a, 300s–3, and 300s–5, and repealing
sections 300o to 300o–3, 300p to 300p–3, 300q–1, and 300s of
this title] shall take effect October 1, 1979, except that
the amendments made by section 201(b) [amending this
section and section 300q–2 of this title] respecting the
payment of an interest subsidy for a loan or loan guarantee made under part A of title XVI of the Public
Health Service Act [this part] shall apply only with respect to loans and loan guarantees made after October
1, 1979, and with respect to loans and loan guarantees
made under such part before such date the Secretary
shall continue to pay the interest subsidy authorized
for such loans and loan guarantees before such date.’’

§ 300q–1. Repealed. Pub. L. 96–79,
§ 203(a)(1), Oct. 4, 1979, 93 Stat. 635

title

II,

Section, act July 1, 1944, ch. 373, title XVI, § 1621, as
added Jan. 4, 1975, Pub. L. 93–641, § 4, 88 Stat. 2265, related to allocation among States of total amount of principal, criteria, availability of unobligated amounts, and
reallotments.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1979, see section 204 of Pub. L.
96–79, set out as an Effective Date of 1979 Amendment
note under section 300q of this title.

§ 300q–2

§ 300q–2. General provisions
(a) Loan guarantees; criteria for approval; recovery of payments by United States; modification, etc., of terms and conditions; incontestability
(1) The Secretary may not approve a loan
guarantee for a project under this part unless he
determines that (A) the terms, conditions, security (if any), and schedule and amount of repayments with respect to the loan are sufficient to
protect the financial interests of the United
States and are otherwise reasonable, including a
determination that the rate of interest does not
exceed such per centum per annum on the principal obligation outstanding as the Secretary
determines to be reasonable, taking into account the range of interest rates prevailing in
the private market for similar loans and the
risks assumed by the United States, and (B) the
loan would not be available on reasonable terms
and conditions without the guarantee under this
part.
(2)(A) The United States shall be entitled to
recover from the applicant for a loan guarantee
under this part the amount of any payment
made pursuant to such guarantee, unless the
Secretary for good cause waives such right of recovery; and, upon making any such payment,
the United States shall be subrogated to all of
the rights of the recipient of the payments with
respect to which the guarantee was made.
(B) To the extent permitted by subparagraph
(C), any terms and conditions applicable to a
loan guarantee under this part (including terms
and conditions imposed under subparagraph (D))
may be modified by the Secretary to the extent
he determines it to be consistent with the financial interest of the United States.
(C) Any loan guarantee made by the Secretary
under this part shall be incontestable (i) in the
hands of an applicant on whose behalf such guarantee is made unless the applicant engaged in
fraud or misrepresentation in securing such
guarantee, and (ii) as to any person (or his successor in interest) who makes or contracts to
make a loan to such applicant in reliance thereon unless such person (or his successor in interest) engaged in fraud or misrepresentation in
making or contracting to make such loan.
(D) Guarantees of loans under this part shall
be subject to such further terms and conditions
as the Secretary determines to be necessary to
assure that the purposes of this subchapter will
be achieved.
(b) Loans; criteria for approval; terms and conditions; waiver of recovery of payments by
United States
(1) The Secretary may not approve a loan
under this part unless—
(A) the Secretary is reasonably satisfied
that the applicant under the project for which
the loan would be made will be able to make
payments of principal and interest thereon
when due, and
(B) the applicant provides the Secretary
with reasonable assurances that there will be
available to it such additional funds as may be
necessary to complete the project or undertaking with respect to which such loan is requested.

§ 300q–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Any loan made under this part shall (A)
have such security, (B) have such maturity date,
(C) be repayable in such installments, (D) bear
interest at a rate comparable to the current rate
of interest prevailing, on the date the loan is
made, with respect to loans guaranteed under
this part, minus any interest subsidy made in
accordance with section 300q(a)(2)(B) of this title
with respect to a loan made for a project located
in an urban or rural poverty area, and (E) be
subject to such other terms and conditions (including provisions for recovery in case of default), as the Secretary determines to be necessary to carry out the purposes of this subchapter while adequately protecting the financial interests of the United States.
(3) The Secretary may, for good cause but with
due regard to the financial interests of the
United States, waive any right of recovery
which he has by reasons of the failure of a borrower to make payments of principal of and interest on a loan made under this part, except
that if such loan is sold and guaranteed, any
such waiver shall have no effect upon the Secretary’s guarantee of timely payment of principal and interest.
(c) Sale of loans; authority; amount; agreements
with purchasers; deposit of proceeds
(1) The Secretary shall from time to time, but
with due regard to the financial interests of the
United States, sell loans made under this part
either on the private market or to the Federal
National Mortgage Association in accordance
with section 1717 of title 12 or to the Federal Financing Bank.
(2) Any loan so sold shall be sold for an
amount which is equal (or approximately equal)
to the amount of the unpaid principal of such
loans as of time of sale.
(3)(A) The Secretary is authorized to enter
into an agreement with the purchaser of any
loan sold under this part under which the Secretary agrees—
(i) to guarantee to such purchaser (and any
successor in interest to such purchaser) payments of the principal and interest payable
under such loan, and
(ii) to pay as an interest subsidy to such purchaser (and any successor in interest of such
purchaser) amounts which, when added to the
amount of interest payable on such loan, are
equivalent to a reasonable rate of interest on
such loan as determined by the Secretary
after taking into account the range of prevailing interest rates in the private market on
similar loans and the risks assumed by the
United States.
(B) Any agreement under subparagraph (A)—
(i) may provide that the Secretary shall act
as agent of any such purchaser, for the purpose of collecting from the entity to which
such loan was made and paying over to such
purchaser any payments of principal and interest payable by such entity under such loan;
(ii) may provide for the repurchase by the
Secretary of any such loan on such terms and
conditions as may be specified in the agreement;
(iii) shall provide that, in the event of any
default by the entity to which such loan was

Page 1054

made in payment of principal or interest due
on such loan, the Secretary shall, upon notification to the purchaser (or to the successor in
interest of such purchaser), have the option to
close out such loan (and any obligations of the
Secretary with respect thereto) by paying to
the purchaser (or his successor in interest) the
total amount of outstanding principal and interest due thereon at the time of such notification; and
(iv) shall provide that, in the event such
loan is closed out as provided in clause (iii), or
in the event of any other loss incurred by the
Secretary by reason of the failure of such entity to make payments of principal or interest
on such loan, the Secretary shall be subrogated to all rights of such purchaser for recovery of such loss from such entity.
(4) Amounts received by the Secretary as proceeds from the sale of loans under this subsection shall be deposited in the fund established under subsection (d) of this section.
(5) If any loan to a public entity under this
part is sold and guaranteed by the Secretary
under this subsection, interest paid on such loan
after its sale and any interest subsidy paid,
under paragraph (3)(A)(ii), by the Secretary with
respect to such loan which is received by the
purchaser of the loan (or the purchaser’s successor in interest) shall be included in the gross income of the purchaser or successor for the purpose of chapter 1 of title 26.
(d) Loan and loan guarantee fund; establishment;
amounts authorized to be appropriated; issuance, purchase, and sale of notes, obligations, etc.; interest rates; public debt transactions
(1) There is established in the Treasury a loan
and loan guarantee fund (hereinafter in this subsection referred to as the ‘‘fund’’) which shall be
available to the Secretary without fiscal year
limitation, in such amounts as may be specified
from time to time in appropriations Acts—
(A) to enable him to make loans under this
part,
(B) to enable him to discharge his responsibilities under loan guarantees issued by him
under this part,
(C) for payment of interest under section
300q(a)(2)(B) of this title on loans guaranteed
under this part,
(D) for repurchase of loans under subsection
(c)(3)(B) of this section,
(E) for payment of interest on loans which
are sold and guaranteed, and
(F) to enable the Secretary to take the action authorized by subsection (f) of this section.
There are authorized to be appropriated from
time to time such amounts as may be necessary
to provide the sums required for the fund. There
shall also be deposited in the fund amounts received by the Secretary in connection with
loans and loan guarantees under this part and
other property or assets derived by him from his
operations respecting such loans and loan guarantees, including any money derived from the
sale of assets.
(2) If at any time the sums in the funds are insufficient to enable the Secretary—

Page 1055

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) to make payments of interest under section 300q(a)(2)(B) of this title,
(B) to otherwise comply with guarantees
under this part of loans to nonprofit private
entities,
(C) in the case of a loan which was made,
sold, and guaranteed under this part, to make
to the purchaser of such loan payments of
principal and interest on such loan after default by the entity to which the loan was
made, or
(D) to repurchase loans under subsection
(c)(3)(B) of this section,
(E) to make payments of interest on loans
which are sold and guaranteed, and
(F) to enable the Secretary to take the action authorized by subsection (f) of this section,
he is authorized to issue to the Secretary of the
Treasury notes or other obligations in such
forms and denominations, bearing such maturities, and subject to such terms and conditions,
as may be prescribed by the Secretary with the
approval of the Secretary of the Treasury. Such
notes or other obligations shall bear interest at
a rate determined by the Secretary of the Treasury, taking into consideration the current average market yield on outstanding marketable obligations of the United States of comparable maturities during the month preceding the issuance of the notes or other obligations. The Secretary of the Treasury shall purchase any notes
and other obligations issued under this paragraph and for that purpose he may use as a public debt transaction the proceeds from the sale
of any securities issued under chapter 31 of title
31, and the purposes for which the securities
may be issued under that chapter are extended
to include any purchase of such notes and obligations. The Secretary of the Treasury may at
any time sell any of the notes or other obligations acquired by him under this paragraph. All
redemptions, purchases, and sales by the Secretary of the Treasury of such notes or other obligations shall be treated as public debt transactions of the United States. Sums borrowed
under this paragraph shall be deposited in the
fund and redemption of such notes and obligations shall be made by the Secretary from the
fund.
(e) Transfers to and additional capitalization of
loan and loan guarantee fund
(1) The assets, commitments, obligations, and
outstanding balances of the loan guarantee and
loan fund established in the Treasury by section
291j–6 of this title shall be transferred to the
fund established by subsection (d) of this section.
(2) To provide additional capitalization for the
fund established under subsection (d) of this section there are authorized to be appropriated to
the fund, such sums as may be necessary for the
fiscal years ending June 30, 1975, June 30, 1976,
September 30, 1977, September 30, 1978, September 30, 1979, September 30, 1980, September 30,
1981, and September 30, 1982.

§ 300q–2

(f) Default prevention measures; terms and conditions; implementation of reforms; foreclosures; protection of Federal interest on
default
(1) The Secretary may take such action as
may be necessary to prevent a default on a loan
made or guaranteed under this part or under
subchapter IV of this chapter, including the
waiver of regulatory conditions, deferral of loan
payments, renegotiation of loans, and the expenditure of funds for technical and consultative
assistance, for the temporary payment of the interest and principal on such a loan, and for
other purposes. Any such expenditure made
under the preceding sentence on behalf of a medical facility shall be made under such terms and
conditions as the Secretary shall prescribe, including the implementation of such organizational, operational, and financial reforms as the
Secretary determines are appropriate and the
disclosure of such financial or other information
as the Secretary may require to determine the
extent of the implementation of such reforms.
(2) The Secretary may take such action, consistent with State law respecting foreclosure
procedures, as he deems appropriate to protect
the interest of the United States in the event of
a default on a loan made or guaranteed under
this part or under subchapter IV of this chapter,
including selling real property pledged as security for such a loan or loan guarantee and for a
reasonable period of time taking possession of,
holding, and using real property pledged as security for such a loan or loan guarantee.
(July 1, 1944, ch. 373, title XVI, § 1602, formerly
§ 1622, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2265; amended Pub. L. 95–83, title I,
§ 106(x)(2), (y), Aug. 1, 1977, 91 Stat. 385; renumbered § 1602 and amended Pub. L. 96–79, title II,
§§ 201(b)(2), (3), 203(a)(1), (3), (g), Oct. 4, 1979, 93
Stat. 631, 635; Pub. L. 97–414, § 8(q), Jan. 4, 1983,
96 Stat. 2062; Pub. L. 99–514, § 2, Oct. 22, 1986, 100
Stat. 2095.)
CODIFICATION
In subsec. (d), ‘‘chapter 31 of title 31’’ and ‘‘that chapter’’ substituted for ‘‘the Second Liberty Bond Act’’
and ‘‘that Act’’, respectively, on authority of Pub. L.
97–258, § 4(b), Sept. 13, 1982, 96 Stat. 1067, the first section of which enacted Title 31, Money and Finance.
PRIOR PROVISIONS
A prior section 1602 of act July 1, 1944, ch. 373, title
XVI, as added Jan. 4, 1975, Pub. L. 93–641, § 4, 88 Stat.
2258; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(r),
(s), 91 Stat. 385, was classified to section 300o–1 of this
title, prior to repeal by Pub. L. 96–79, title II, § 202(a),
Oct. 4, 1979, 93 Stat. 632.
AMENDMENTS
1986—Subsec. (c)(5). Pub. L. 99–514 substituted ‘‘Internal Revenue Code of 1986’’ for ‘‘Internal Revenue Code
of 1954’’, which for purposes of codification was translated as ‘‘title 26’’ thus requiring no change in text.
1983—Subsec. (f)(2). Pub. L. 97–414 inserted ‘‘selling
real property pledged as security for such a loan or
loan guarantee and’’ after ‘‘including’’.
1979—Subsec. (b)(2)(D). Pub. L. 96–79, § 201(b)(2), substituted ‘‘minus any interest subsidy made in accordance with section 300q(a)(2)(B) of this title (with respect to a loan made for a project located in an urban
or rural poverty area’’ for ‘‘minus 3 per centum per
annum’’.

§ 300r

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (d)(1). Pub. L. 96–79, § 203(a)(3), (g)(2), substituted
in
subpar.
(C)
reference
to
section
‘‘300q(a)(2)(B)’’ for ‘‘300q(b)(2)’’ of this title, and added
subpar. (F).
Subsec. (d)(2). Pub. L. 96–79, § 203(a)(3), (g)(3), substituted
in
subpar.
(A)
reference
to
section
‘‘300q(a)(2)(B)’’ for ‘‘300q(b)(2)’’ of this title, and added
subpar. (F).
Subsec. (e)(2). Pub. L. 96–79, § 201(b)(3), authorized appropriations for fiscal years ending Sept. 30, 1979
through 1982.
Subsec. (f). Pub. L. 96–79, § 203(g)(1), added subsec. (f).
1977—Subsec. (c)(5). Pub. L. 95–83, § 106(y), added subsec. (c)(5).
Subsec. (e)(2). Pub. L. 95–83, § 106(x)(2), substituted
provisions authorizing appropriations for fiscal years
ending Sept. 30, 1977 and 1978, for prior such authorization for fiscal year ending June 30, 1977.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective Oct. 1, 1979, except that amendment of subsec. (b)(2)(D) respecting interest subsidy payments for loans or loan guarantees
applicable only with respect to loans and loan guarantees made after Oct. 1, 1979, and that subsidies for such
commitments made before Oct. 1, 1979, payable as authorized before Oct. 1, 1979, see section 204 of Pub. L.
96–79, set out as a note under section 300q of this title.

PART B—PROJECT GRANTS
AMENDMENTS
1979—Pub. L. 96–79, title II, §§ 201(a), 202(a), Oct. 4,
1979, 93 Stat. 630, 632, repealed part B relating to allotments, and comprising former sections 300p to 300p–3 of
this title, and redesignated former part D as part B relating to project grants.

§ 300r. Grants for construction or modernization
projects
(a) Authority; objectives; eligible grantees; maximum amounts; authorization of appropriations; availability of unobligated funds
(1)(A) The Secretary may make grants for construction or modernization projects designed
to—
(i) eliminate or prevent in medical facilities
imminent safety hazards as defined by Federal, State, or local fire, building, or life safety codes or regulations, or
(ii) avoid noncompliance by medical facilities with State or voluntary licensure or accreditation standards.
(B) A grant under subparagraph (A) may only
be made to—
(i) a State or political subdivision of a State,
including any city, town, county, borough,
hospital district authority, or public or quasipublic corporation, for any medical facility
owned or operated by the State or political
subdivision; and
(ii) a nonprofit private entity for any medical facility owned or operated by the entity
but only if the Secretary determines—
(I) the level of community service provided
by the facility and the proportion of its patients who are unable to pay for services
rendered in the facility is similar to such
level and proportion in a medical facility of
a State or political subdivision, and
(II) that without a grant under subparagraph (A) there would be a disruption of the
provision of health care to low-income individuals.

Page 1056

(2) The amount of any grant under paragraph
(1) may not exceed 75 per centum of the cost of
the project for which the grant is made unless
the project is located in an area determined by
the Secretary to be an urban or rural poverty
area, in which case the grant may cover up to
100 per centum of such costs.
(3) There are authorized to be appropriated for
grants under paragraph (1) $40,000,000 for the fiscal year ending September 30, 1980, $50,000,000 for
the fiscal year ending September 30, 1981, and
$50,000,000 for the fiscal year ending September
30, 1982. Funds available for obligation under
this subsection (as in effect before October 4,
1979) in the fiscal year ending September 30,
1979, shall remain available for obligation under
this subsection in the succeeding fiscal year.
(b) Projects for medically underserved populations; eligible grantees; maximum amounts;
authorization of appropriations
(1) The Secretary may make grants to public
and nonprofit private entities for projects for
(A) construction or modernization of outpatient
medical facilities which are located apart from
hospitals and which will provide services for
medically underserved populations, and (B) conversion of existing facilities into outpatient
medical facilities or facilities for long-term care
to provide services for such populations.
(2) The amount of any grant under paragraph
(1) may not exceed 80 per centum of the cost of
the project for which the grant is made unless
the project is located in an area determined by
the Secretary to be an urban or rural poverty
area, in which case the grant may cover up to
100 per centum of such costs.
(3) There are authorized to be appropriated for
grants under paragraph (1) $15,000,000 for the fiscal year ending September 30, 1981, and
$15,000,000 for the fiscal year ending September
30, 1982.
(July 1, 1944, ch. 373, title XVI, § 1610, formerly
§ 1625, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2268; amended Pub. L. 95–83, title I, § 103(b),
Aug. 1, 1977, 91 Stat. 383; renumbered § 1610 and
amended Pub. L. 96–79, title II, §§ 201(c), 203(b),
Oct. 4, 1979, 93 Stat. 631, 635.)
PRIOR PROVISIONS
A prior section 1610 of act July 1, 1944, ch. 373, title
XVI, as added Jan. 4, 1975, Pub. L. 93–641, § 4, 88 Stat.
2262; amended Aug. 1, 1977, Pub. L. 95–83, title I, § 106(w),
91 Stat. 385, was classified to section 300p of this title,
prior to repeal by Pub. L. 96–79, title II, § 201(a), Oct. 4,
1979, 93 Stat. 630.
AMENDMENTS
1979—Subsec. (a). Pub. L. 96–79, § 201(c), incorporated
existing provisions in par. (1); inserted in subpar. (A) in
cls. (i) and (ii) the phrases ‘‘in medical facilities’’ and
‘‘by medical facilities’’; substituted in subpar. (B)(i)
‘‘for any medical facility owned or operated by the
State or political subdivision’’ for ‘‘for a project described in the preceding sentence for any medical facility owned or operated by it’’; added cl. (a)(1)(B)(ii); redesignated former subsec. (c) as par. (2); and added par.
(3).
Subsec. (b). Pub. L. 96–79, § 201(c), inserted provisions
respecting projects for medically underserved populations and struck out provisions respecting criteria for
approval of applications under former section 300o–3 of
this title.

Page 1057

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (c). Pub. L. 96–79, § 201(c), redesignated subsec.
(c) as par. (2) of subsec. (a).
Subsec. (d). Pub. L. 96–79, § 201(c), struck out subsec.
(d) which related to provisions making available 22 per
centum of sums appropriated under former section
300p–3 of this title for subsec. (a) grants, including an
additional appropriations authorization of $67,500,000
for such grants for fiscal year ending Sept. 30, 1978.
1977—Subsec. (d). Pub. L. 95–83 authorized additional
grant appropriations of $67,500,000 for fiscal year ending
Sept. 30, 1978.

§ 300s–1

compliance with assurances made in connection
with receipt of financial assistance shall submit
periodically to the Secretary data and information which reasonably supports the entity’s
compliance with such assurances. The Secretary
may not waive the requirement of the preceding
sentence.
(July 1, 1944, ch. 373, title XVI, § 1620, as added
Pub. L. 96–79, title II, § 202(b), Oct. 4, 1979, 93
Stat. 632.)

EFFECTIVE DATE OF 1979 AMENDMENT

PRIOR PROVISIONS

Amendment by Pub. L. 96–79 effective Oct. 1, 1979, see
section 204 of Pub. L. 96–79, set out as a note under section 300q of this title.

A prior section 300s, act July 1, 1944, ch. 373, title
XVI, § 1630, as added Jan. 4, 1975, Pub. L. 93–641, § 4, 88
Stat. 2269, provided for judicial review by the United
States Court of Appeals, prior to repeal by Pub. L.
96–79, § 202(b), eff. Oct. 1, 1979.
A prior section 1620 of act July 1, 1944, was renumbered section 1601 by Pub. L. 96–79, title II, § 203(a)(1),
Oct. 4, 1979, 93 Stat. 635, and is classified to section 300q
of this title.

PART C—GENERAL PROVISIONS
AMENDMENTS
1979—Pub. L. 96–79, title II, § 202(a), Oct. 4, 1979, 93
Stat. 632, redesignated former part E as part C relating
to general provisions and former part C as part A.

§ 300s. General regulations
The Secretary shall by regulation—
(1) prescribe the manner in which he shall
determine the priority among projects for
which assistance is available under part A or
B, based on the relative need of different areas
for such projects and giving special consideration—
(A) to projects for medical facilities serving areas with relatively small financial resources and for medical facilities serving
rural communities,
(B) in the case of projects for modernization of medical facilities, to projects for facilities serving densely populated areas,
(C) in the case of projects for construction
of outpatient medical facilities, to projects
that will be located in, and provide services
for residents of, areas determined by the
Secretary to be rural or urban poverty areas,
(D) to projects designed to (i) eliminate or
prevent imminent safety hazards as defined
by Federal, State, or local fire, building, or
life safety codes or regulations, or (ii) avoid
noncompliance with State or voluntary licensure or accreditation standards, and
(E) to projects for medical facilities which,
alone or in conjunction with other facilities,
will provide comprehensive health care, including outpatient and preventive care as
well as hospitalization;
(2) prescribe for medical facilities projects
assisted under part A or B general standards of
construction, modernization, and equipment,
which standards may vary on the basis of the
class of facilities and their location; and
(3) prescribe the general manner in which
each entity which receives financial assistance
under part A or B or has received financial assistance under part A or B or subchapter IV of
this chapter shall be required to comply with
the assurances required to be made at the
time such assistance was received and the
means by which such entity shall be required
to demonstrate compliance with such assurances.
An entity subject to the requirements prescribed pursuant to paragraph (3) respecting

EFFECTIVE DATE
Section effective Oct. 1, 1979, see section 204 of Pub.
L. 96–79, set out as an Effective Date of 1979 Amendment note under section 300q of this title.

§ 300s–1. Medical facility project applications
(a) Submissions
No loan, loan guarantee, or grant may be
made under part A or B for a medical facilities
project unless an application for such project
has been submitted to and approved by the Secretary. If two or more entities join in a project,
an application for such project may be filed by
any of such entities or by all of them.
(b) Form; required provisions; waiver; projects
subject to requirements
(1) An application for a medical facilities project shall be submitted in such form and manner
as the Secretary shall by regulation prescribe
and shall, except as provided in paragraph (2),
set forth—
(A) in the case of a modernization project for
a medical facility for continuation of existing
health services, a finding by the State Agency
of a continued need for such services, and, in
the case of any other project for a medical facility, a finding by the State Agency of the
need for the new health services to be provided
through the medical facility upon completion
of the project;
(B) in the case of an application for a grant,
assurances satisfactory to the Secretary that
(i) the applicant making the application would
not be able to complete the project for which
the application is submitted without the grant
applied for, and (ii) in the case of a project to
construct a new medical facility, it would be
inappropriate to convert an existing medical
facility to provide the services to be provided
through the new medical facility;
(C) in the case of a project for the discontinuance of a service or facility or the conversion of a service or a facility, an evaluation
of the impact of such discontinuance or conversion on the provision of health care in the
health service area in which such service was
provided or facility located;
(D) a description of the site of such project;
(E) plans and specifications therefor which
meet the requirements of the regulations prescribed under section 300s(2) of this title;

§ 300s–1a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(F) reasonable assurance that title to such
site is or will be vested in one or more of the
entities filing the application or in a public or
other nonprofit entity which is to operate the
facility on completion of the project;
(G) reasonable assurance that adequate financial support will be available for the completion of the project and for its maintenance
and operation when completed, and, for the
purpose of determining if the requirements of
this subparagraph are met, Federal assistance
provided directly to a medical facility which
is located in an area determined by the Secretary to be an urban or rural poverty area or
through benefits provided individuals served
at such facility shall be considered as financial support;
(H) the type of assistance being sought under
part A or B for the project;
(I) reasonable assurance that all laborers
and mechanics employed by contractors or
subcontractors in the performance of work on
a project will be paid wages at rates not less
than those prevailing on similar construction
in the locality as determined by the Secretary
of Labor in accordance with sections 3141–3144,
3146, and 3147 of title 40, and the Secretary of
Labor shall have with respect to such labor
standards the authority and functions set
forth in Reorganization Plan Numbered 14 of
1950 (15 FR 3176; 5 U.S.C. Appendix) and section
3145 of title 40;
(J) in the case of a project for the construction or modernization of an outpatient facility, reasonable assurance that the services of
a general hospital will be available to patients
at such facility who are in need of hospital
care; and
(K) reasonable assurance that at all times
after such application is approved (i) the facility or portion thereof to be constructed, modernized, or converted will be made available to
all persons residing or employed in the area
served by the facility, and (ii) there will be
made available in the facility or portion thereof to be constructed, modernized, or converted
a reasonable volume of services to persons unable to pay therefor and the Secretary, in determining the reasonableness of the volume of
services provided, shall take into consideration the extent to which compliance is feasible from a financial viewpoint.
(2)(A) The Secretary may waive—
(i) the requirements of subparagraph (D) of
paragraph (1) for compliance with modernization and equipment standards prescribed pursuant to section 300s(2) of this title, and
(ii) the requirement of subparagraph (E) of
paragraph (1) respecting title to a project site,
in the case of an application for a project described in subparagraph (B) of this paragraph.
(B) A project referred to in subparagraph (A) is
a project—
(i) for the modernization of an outpatient
medical facility which will provide general
purpose health services, which is not part of a
hospital, and which will serve a medically underserved population as defined in section
300s–3 of this title or as designated by a health
systems agency, and

Page 1058

(ii) for which the applicant seeks a loan
under part A the principal amount of which
does not exceed $20,000.
(July 1, 1944, ch. 373, title XVI, § 1621, as added
Pub. L. 96–79, title II, § 202(b), Oct. 4, 1979, 93
Stat. 633.)
CODIFICATION
In subsec. (b)(1)(I), ‘‘sections 3141–3144, 3146, and 3147
of title 40’’ substituted for ‘‘the Act of March 3, 1931 (40
U.S.C. 276a—276a–5, known as the Davis-Bacon Act)’’
and ‘‘section 3145 of title 40’’ substituted for ‘‘section 2
of the Act of June 13, 1934 (40 U.S.C. 276c)’’ on authority
of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303, the
first section of which enacted Title 40, Public Buildings, Property, and Works.
PRIOR PROVISIONS
A prior section 300s–1 was redesignated 300s–1a and
amended as part of the general revision of this subchapter by Pub. L. 96–79.
A prior section 1621 of act July 1, 1944, as added Jan.
4, 1975, Pub. L. 93–641, § 4, 88 Stat. 2265, which related to
the allocation among States of the total amount of
principal of loans and loan guarantees, was classified to
section 300q–1 of this title, prior to repeal as part of the
general revision of this subchapter by Pub. L. 96–79.
EFFECTIVE DATE
Section effective Oct. 1, 1979, see section 204 of Pub.
L. 96–79, set out as an Effective Date of 1979 Amendment note under section 300q of this title.

§ 300s–1a. Recovery of expenditures under certain conditions
(a) Persons liable
If any facility with respect to which funds
have been paid under this subchapter shall, at
any time within 20 years after the completion of
construction or modernization—
(1) be sold or transferred to any entity (A)
which is not qualified to file an application
under section 300s–1 or 300t–12 of this title or
(B) which is not approved as a transferee by
the State Agency of the State in which such
facility is located, or its successor, or
(2) cease to be a public health center or a
public or other nonprofit hospital, outpatient
facility, facility for long-term care, or rehabilitation facility,
the United States shall be entitled to recover,
whether from the transferor or the transferee
(or, in the case of a facility which has ceased to
be public or nonprofit, from the owners thereof)
an amount determined under subsection (c) of
this section.
(b) Notice to Secretary
The transferor of a facility which is sold or
transferred as described in subsection (a)(1) of
this section, or the owner of a facility the use of
which is changed as described in subsection
(a)(2) of this section, shall provide the Secretary
written notice of such sale, transfer, or change
not later than the expiration of 10 days from the
date on which such sale, transfer, or change occurs.
(c) Amount of recovery; interest; interest period
(1) Except as provided in paragraph (2), the
amount the United States shall be entitled to
recover under subsection (a) of this section is an

Page 1059

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amount bearing the same ratio to the then value
(as determined by the agreement of the parties
or in an action brought in the district court of
the United States for the district for which the
facility involved is situated) of so much of the
facility as constituted an approved project or
projects as the amount of the Federal participation bore to the cost of the construction or modernization of such project or projects.
(2)(A) After the expiration of—
(i) 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b) of this section in the
case of a facility which is sold or transferred
or the use of which changes after July 18, 1984,
or
(ii) thirty days after July 18, 1984, or if later
180 days after the date of the sale, transfer, or
change of use for which a notice is required by
subsection (b) of this section, in the case of a
facility which was sold or transferred or the
use of which changed before July 18, 1984,
the amount which the United States is entitled
to recover under paragraph (1) with respect to a
facility shall be the amount prescribed by paragraph (1) plus interest, during the period described in subparagraph (B), at a rate (determined by the Secretary) based on the average of
the bond equivalent of the weekly 90-day Treasury bill auction rate.
(B) The period referred to in subparagraph (A)
is the period beginning—
(i) in the case of a facility which was sold or
transferred or the use of which changed before
July 18, 1984, thirty days after such date or if
later 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b) of this section.1
(ii) in the case of a facility with respect to
which notice is provided in accordance with
subsection (b) of this section, upon the expiration of 180 days after the receipt of such notice, or
(iii) in the case of a facility with respect to
which such notice is not provided as prescribed by subsection (b) of this section, on
the date of the sale, transfer, or changes of use
for which such notice was to be provided,
and ending on the date the amount the United
States is entitled to under paragraph (1) is collected.
(d) Waiver
(1) The Secretary may waive the recovery
rights of the United States under subsection
(a)(1) of this section with respect to a facility in
any State if the Secretary determines, in accordance with regulations, that the entity to
which the facility was sold or transferred—
(A) has established an irrevocable trust—
(i) in an amount equal to the greater of
twice the cost of the remaining obligation of
the facility under clause (ii) of section
300s–1(b)(1)(K) of this title or the amount,
determined under subsection (c) of this section, that the United States is entitled to recover, and
(ii) which will only be used by the entity
to provide the care required by clause (ii) of
section 300s–1(b)(1)(K) of this title; and
1 So

in original. The period probably should be a comma.

§ 300s–1a

(B) will meet the obligation of the facility
under clause (i) of section 300s–1(b)(1)(K) of
this title.
(2) The Secretary may waive the recovery
rights of the United States under subsection
(a)(2) of this section with respect to a facility in
any State if the Secretary determines, in accordance with regulations, that there is good
cause for waiving such rights with respect to
such facility.
(e) Lien
The right of recovery of the United States
under subsection (a) of this section shall not
constitute a lien on any facility with respect to
which funds have been paid under this subchapter.
(July 1, 1944, ch. 373, title XVI, § 1622, formerly
§ 1631, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2269; amended Pub. L. 94–278, title XI,
§ 1106(c), Apr. 22, 1976, 90 Stat. 416; renumbered
§ 1622 and amended Pub. L. 96–79, title II,
§§ 202(b), 203(c), Oct. 4, 1979, 93 Stat. 632, 635; Pub.
L. 98–369, div. B. title III, § 2381(b), July 18, 1984,
98 Stat. 1114.)
CODIFICATION
Section was formerly classified to section 300s–1 of
this title prior to the general revision of this subchapter by Pub. L. 96–79.
PRIOR PROVISIONS
A prior section 1622 of act July 1, 1944, as added Jan.
4, 1975, Pub. L. 93–641, § 4, 88 Stat. 2265, was renumbered
section 1602 as part of the general revision of this subchapter by Pub. L. 96–79 and is classified to section
300q–2 of this title.
AMENDMENTS
1984—Pub. L. 98–369 amended section generally. Prior
to the amendment, section read as follows:
‘‘(a) If any facility constructed, modernized, or converted with funds provided under this subchapter is, at
any time within twenty years after the completion of
such construction, modernization, or conversion with
such funds—
‘‘(1) sold or transferred to any person or entity (A)
which is not qualified to file an application under
section 300s–1 or 300t–12 of this title or (B) which is
not approved as a transferee by the State Agency of
the State in which such facility is located, or its successor; or
‘‘(2) not used as a medical facility, and the Secretary has not determined that there is good cause
for termination of such use,
the United States shall be entitled to recover from either the transferor or the transferee in the case of a
sale or transfer or from the owner in the case of termination of use an amount bearing the same ratio to the
then value (as determined by the agreement of the parties or by action brought in the district court of the
United States for the district in which the facility is
situated) of so much of such facility as constituted an
approved project or projects, as the amount of the Federal participation bore to the cost of the construction,
modernization, or conversion of such project or
projects. Such right of recovery shall not constitute a
lien upon such facility prior to judgment.
‘‘(b) The Secretary may waive the recovery rights of
the United States under subsection (a) of this section
with respect to a facility in any State—
‘‘(1) if (as determined under regulations prescribed
by the Secretary) the amount which could be recovered under subsection (a) of this section with respect
to such facility is applied to the development, expan-

§ 300s–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

sion, or support of another medical facility located in
such State which has been approved by the Statewide
Health Coordinating Council for such State as consistent with the State health plan established pursuant to section 300m–3(c) of this title; or
‘‘(2) if the Secretary determines, in accordance with
regulations, that there is good cause for waiving such
requirement with respect to such facility.
If the amount which the United States is entitled to recover under subsection (a) of this section exceeds 90 per
centum of the total cost of the construction or modernization project for a facility, a waiver under this
subsection shall only apply with respect to an amount
which is not more than 90 per centum of such total
cost.’’
1979—Subsec. (a)(1)(A). Pub. L. 96–79, § 203(c), substituted ‘‘section 300s–1 or 300t–12 of this title’’ for ‘‘section 300o–3 of this title’’.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective Oct. 1, 1979, see
section 204 of Pub. L. 96–79, set out as a note under section 300q of this title.
REGULATIONS AND PERSONNEL
Requirements for regulations and personnel to implement this section, see section 2381(c) of Pub. L. 98–369,
set out as a note under section 291i of this title.

§ 300s–2. State supervision or control of operations of facilities receiving funds
Except as otherwise specifically provided,
nothing in this subchapter shall be construed as
conferring on any Federal officer or employee,
the right to exercise any supervision or control
over the administration, personnel, maintenance, or operation of any facility with respect
to which any funds have been or may be expended under this subchapter.
(July 1, 1944, ch. 373, title XVI, § 1623, formerly
§ 1632, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2270; renumbered § 1623, Pub. L. 96–79, title
II, § 202(b), Oct. 4, 1979, 93 Stat. 632.)
§ 300s–3. Definitions
Except as provided in section 300t–12(e) of this
title, for purposes of this subchapter—
(1) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related facilities, such as laboratories, outpatient
departments, nurses’ home facilities, extended
care facilities, facilities related to programs for
home health services, self-care units, and central service facilities, operated in connection
with hospitals, and also includes education or
training facilities for health professonal 1 personnel operated as an integral part of a hospital,
but does not include any hospital furnishing primarily domiciliary care.
(2) The term ‘‘public health center’’ means a
publicly owned facility for the provision of public health services, including related publicly
owned facilities such as laboratories, clinics,
and administrative offices operated in connection with such a facility.
(3) The term ‘‘nonprofit’’ as applied to any facility means a facility which is owned and operated by one or more nonprofit corporations or
associations no part of the net earnings of which
inures, or may lawfully inure, to the benefit of
any private shareholder or individual.
1 So

in original. Probably should be ‘‘professional’’.

Page 1060

(4) The term ‘‘outpatient medical facility’’
means a medical facility (located in or apart
from a hospital) for the diagnosis or diagnosis
and treatment of ambulatory patients (including ambulatory inpatients)—
(A) which is operated in connection with a
hospital,
(B) in which patient care is under the professional supervision of persons licensed to practice medicine or surgery in the State, or in the
case of dental diagnosis or treatment, under
the professional supervision of persons licensed to practice dentistry in the State; or
(C) which offers to patients not requiring
hospitalization the services of licensed physicians in various medical specialties, and which
provides to its patients a reasonably full-range
of diagnostic and treatment services.
(5) The term ‘‘rehabilitation facility’’ means a
facility which is operated for the primary purpose of assisting in the rehabilitation of disabled
persons through an integrated program of—
(A) medical evaluation and services, and
(B) psychological, social, or vocational evaluation and services,
under competent professional supervision, and
in the case of which the major portion of the required evaluation and services is furnished within the facility; and either the facility is operated in connection with a hospital, or all medical and related health services are prescribed by,
or are under the general direction of, persons licensed to practice medicine or surgery in the
State.
(6) The term ‘‘facility for long-term care’’
means a facility (including a skilled nursing or
intermediate care facility) providing in-patient
care for convalescent or chronic disease patients
who required skilled nursing or intermediate
care and related medical services—
(A) which is a hospital (other than a hospital
primarily for the care and treatment of mentally ill or tuberculous patients) or is operated
in connection with a hospital, or
(B) in which such care and medical services
are prescribed by, or are performed under the
general direction of, persons licensed to practice medicine or surgery in the State.
(7) The term ‘‘construction’’ means construction of new buildings and initial equipment of
such buildings and, in any case in which it will
help to provide a service not previously provided
in the community, equipment of any buildings;
including architects’ fees, but excluding the cost
of off-site improvements and, except with respect to public health centers, the cost of the
acquisition of land.
(8) The term ‘‘cost’’ as applied to construction,
modernization, or conversion means the amount
found by the Secretary to be necessary for construction, modernization, or conversion, respectively, under a project, except that, in the case
of a modernization project or a project assisted
under part B of this subchapter, such term does
not include any amount found by the Secretary
to be attributable to expansion of the bed capacity of any facility.
(9) The term ‘‘modernization’’ includes the alteration, expansion, major repair (to the extent
permitted by regulations), remodeling, replace-

Page 1061

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment, and renovation of existing buildings (including initial equipment thereof), and the replacement of obsolete equipment of existing
buildings.
(10) The term ‘‘title,’’ 2 when used with reference to a site for a project, means a fee simple, or such other estate or interest (including a
leasehold on which the rental does not exceed 4
per centum of the value of the land) as the Secretary finds sufficient to assure for a period of
not less than twenty-five years’ undisturbed use
and possession for the purposes of construction,
modernization, or conversion and operation of
the project for a period of not less than (A)
twenty years in the case of a project assisted
under an allotment or grant under this subchapter, or (B) the term of repayment of a loan
made or guaranteed under this subchapter in the
case of a project assisted by a loan or loan guarantee.
(11) The term ‘‘medical facility’’ means a hospital, public health center, outpatient medical
facility, rehabilitation facility, facility for longterm care, or other facility (as may be designated by the Secretary) for the provision of
health care to ambulatory patients.
(12) The term ‘‘State Agency’’ means the State
health planning and development agency of a
State designated under subchapter XIII of this
chapter.3
(13) The term ‘‘urban or rural poverty area’’
means an urban or rural geographical area (as
defined by the Secretary) in which a percentage
(as defined by the Secretary in accordance with
the next sentence) of the residents of the area
have incomes below the poverty level (as defined
by the Secretary of Commerce). The percentage
referred to in the preceding sentence shall be defined so that the percentage of the population of
the United States residing in urban and rural
poverty areas is—
(A) not more than the percentage of the
total population of the United States with incomes below the poverty level (as so defined)
plus five per centum, and
(B) not less than such percentage minus five
per centum.
(14) The term ‘‘medically underserved population’’ means the population of an urban or
rural area designated by the Secretary as an
area with a shortage of health facilities or a
population group designated by the Secretary as
having a shortage of such facilities.
(July 1, 1944, ch. 373, title XVI, § 1624, formerly
§ 1633, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2270; amended Pub. L. 94–484, title IX,
§ 905(b)(1), Oct. 12, 1976, 90 Stat. 2325; Pub. L.
95–83, title I, § 106(z), Aug. 1, 1977, 91 Stat. 386; renumbered § 1624 and amended Pub. L. 96–79, title
II, §§ 202(b), 203(e)(1), title III, § 301(b), Oct. 4, 1979,
93 Stat. 632, 635, 640.)
REFERENCES IN TEXT
Subchapter XIII of this chapter, referred to in par.
(12), was repealed effective Jan. 1, 1987, by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799.
2 So in original. The comma probably should follow the ending
quotations.
3 See References in Text note below.

§ 300s–4

CODIFICATION
‘‘Part B of this subchapter’’ substituted for ‘‘Part D
of this subchapter’’ in par. (8) pursuant to the redesignation of former part D of this subchapter as B by Pub.
L. 96–79, title II, § 202(a), Oct. 4, 1979, 93 Stat. 632.
AMENDMENTS
1979—Pub. L. 96–79, § 301(b), inserted ‘‘Except as provided in section 300t–12(e) of this title’’.
Pars. (1) to (16). Pub. L. 96–79, § 203(e)(1), struck out
pars. (1) and (2) which defined ‘‘State’’ and ‘‘Federal
share’’ and redesignated pars. (3) through (16) as pars.
(1) through (14), respectively.
1977—Par. (14). Pub. L. 95–83 substituted ‘‘subchapter
XIII’’ for ‘‘subchapter XII’’.
1976—Par. (1). Pub. L. 94–484 defined ‘‘State’’ to include Northern Mariana Islands.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective Oct. 1, 1979, see
section 204 of Pub. L. 96–79, set out as a note under section 300q of this title.

§ 300s–4. Reporting and audit requirements for
recipients
(a) Filing of financial statement with appropriate State Agency; form and contents
In the case of any facility for which an allotment payment, grant, loan, or loan guarantee
has been made under this subchapter, the applicant for such payment, grant, loan, or loan
guarantee (or, if appropriate, such other person
as the Secretary may prescribe) shall file at
least annually with the State Agency for the
State in which the facility is located a statement which shall be in such form, and contain
such information, as the Secretary may require
to accurately show—
(1) the financial operations of the facility,
and
(2) the costs of the facility of providing
health services in the facility and the charges
made by the facility for providing such services,
during the period with respect to which the
statement is filed.
(b) Maintenance of records; access to books, etc.,
for audit and examination
(1) Each entity receiving Federal assistance
under this subchapter shall keep such records as
the Secretary shall prescribe, including records
which fully disclose the amount and disposition
by such entity of the proceeds of such assistance, the total cost of the project in connection
with which such assistance is given or used, the
amount of that portion of the cost of the project
supplied by other sources, and such other
records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General
of the United States, or any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any
books, documents, papers, and records of such
entities which in the opinion of the Secretary or
the Comptroller General may be related or pertinent to the assistance referred to in paragraph
(1).
(c) Filing of financial statement with Secretary;
form and contents
Each such entity shall file at least annually
with the Secretary a statement which shall be

§ 300s–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

in such form, and contain such information, as
the Secretary may require to accurately show—
(1) the financial operations of the facility
constructed or modernized with such assistance, and
(2) the costs to such facility of providing
health services in such facility, and the
charges made for such services, during the period with respect to which the statement is
filed.
(July 1, 1944, ch. 373, title XVI, § 1625, formerly
§ 1634, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2273; renumbered § 1625, Pub. L. 96–79, title
II, § 202(b), Oct. 4, 1979, 93 Stat. 632.)
PRIOR PROVISIONS
A prior section 1625 of act July 1, 1944, was renumbered section 1610 by Pub. L. 96–79, title II, § 203(b), Oct.
4, 1979, 93 Stat. 635, and is classified to section 300r of
this title.

§ 300s–5. Availability of technical and other nonfinancial assistance to eligible applicants
The Secretary shall provide (either through
the Department of Health and Human Services
or by contract) all necessary technical and other
nonfinancial assistance to any public or other
entity which is eligible to apply for assistance
under this subchapter to assist such entity in
developing applications to be submitted to the
Secretary under section 300s–1 or 300t–12 of this
title. The Secretary shall make every effort to
inform eligible applicants of the availability of
assistance under this subchapter.
(July 1, 1944, ch. 373, title XVI, § 1626, formerly
§ 1635, as added Pub. L. 93–641, § 4, Jan. 4, 1975, 88
Stat. 2273; renumbered § 1626 and amended Pub.
L. 96–79, title II, §§ 202(b), 203(f), Oct. 4, 1979, 93
Stat. 632, 635; Pub. L. 96–88, title V, § 509(b), Oct.
17, 1979, 93 Stat. 695.)
AMENDMENTS
1979—Pub. L. 96–79, § 203(f), substituted ‘‘other entity’’
for ‘‘other nonprofit entity’’ and ‘‘section 300s–1 or
300t–12 of this title’’ for ‘‘section 300o–3 of this title.’’
CHANGE OF NAME
‘‘Department of Health and Human Services’’ substituted in text for ‘‘Department of Health, Education,
and Welfare’’ pursuant to section 509(b) of Pub. L. 96–88
which is classified to section 3508(b) of Title 20, Education.
EFFECTIVE DATE OF 1979 AMENDMENT
Amendment by Pub. L. 96–79 effective Oct. 1, 1979, see
section 204 of Pub. L. 96–79, set out as a note under section 300q of this title.

§ 300s–6. Enforcement of assurances
The Secretary shall investigate and ascertain,
on a periodic basis, with respect to each entity
which is receiving financial assistance under
this subchapter or which has received financial
assistance under subchapter IV of this chapter
or this subchapter, the extent of compliance by
such entity with the assurances required to be
made at the time such assistance was received.
If the Secretary finds that such an entity has
failed to comply with any such assurance, the
Secretary shall report such noncompliance to
the health systems agency for the health service

Page 1062

area in which such entity is located and the
State health planning and development agency
of the State in which the entity is located and
shall take any action authorized by law (including an action for specific performance brought
by the Attorney General upon request of the
Secretary) which will effect compliance by the
entity with such assurances. An action to effectuate compliance with any such assurance may
be brought by a person other than the Secretary
only if a complaint has been filed by such person
with the Secretary and the Secretary has dismissed such complaint or the Attorney General
has not brought a civil action for compliance
with such assurance within six months after the
date on which the complaint was filed with the
Secretary.
(July 1, 1944, ch. 373, title XVI, § 1627, as added
Pub. L. 96–79, title II, § 202(c), Oct. 4, 1979, 93
Stat. 634.)
EFFECTIVE DATE
Section effective Oct. 1, 1979, see section 204 of Pub.
L. 96–79, set out as an Effective Date of 1979 Amendment note under section 300q of this title.

PART D—AREA HEALTH SERVICES DEVELOPMENT
FUNDS
AMENDMENTS
1979—Pub. L. 96–79, title II, § 202(a), Oct. 4, 1979, 93
Stat. 632, redesignated former part F as part D relating
to area health services development funds and former
part D as part B.

§ 300t. Development grants for health systems
agencies
(a) Eligible recipients; purpose of grants
The Secretary shall make in each fiscal year a
grant to each health system agency—
(1) with which there is in effect a designation agreement under section 300l–4(c) 1 of this
title,
(2) which has in effect an HSP and AIP reviewed by the Statewide Health Coordinating
Council, and
(3) which, as determined under the review
made under section 300n–4(c) 1 of this title, is
organized and operated in the manner prescribed by section 300l–1(b) 1 of this title and is
performing its functions under section 300l–2 1
of this title in a manner satisfactory to the
Secretary,
to enable the agency to establish and maintain
an Area Health Service Development Fund from
which it may make grants and enter into contracts in accordance with section 300l–2(c)(3) 1 of
this title.
(b) Determination of amounts; maximum
amounts
(1) Except as provided in paragraph (2), the
amount of any grant under subsection (a) of this
section shall be determined by the Secretary
after taking into consideration the population
of the health service area for which the health
systems agency is designated, the average family income of the area, and the supply of health
services in the area.
1 See

References in Text note below.

Page 1063

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) The amount of any grant under subsection
(a) of this section to a health systems agency for
any fiscal year may not exceed the product of $1
and the population of the health service area for
which such agency is designated.
(c) Applications; submission and approval as prerequisite; form and contents
No grant may be made under subsection (a) of
this section unless an application therefor has
been submitted to, and approved by, the Secretary. Such an application shall be submitted
in such form and manner and contain such information as the Secretary may require.
(d) Authorization of appropriations
For the purpose of making payments pursuant
to grants under subsection (a) of this section,
there are authorized to be appropriated
$25,000,000 for the fiscal year ending June 30,
1975, $75,000,000 for the fiscal year ending June
30, 1976, $120,000,000 each for the fiscal years ending September 30, 1977, and September 30, 1978,
$20,000,000 for the fiscal year ending September
30, 1981, and $30,000,000 for the fiscal year ending
September 30, 1982.
(July 1, 1944, ch. 373, title XVI, § 1640, as added
Pub. L. 93–641, § 4, Jan. 4, 1975, 88 Stat. 2273;
amended Pub. L. 95–83, title I, § 103(c), Aug. 1,
1977, 91 Stat. 383; Pub. L. 96–79, title I, § 127(e),
Oct. 4, 1979, 93 Stat. 629.)
REFERENCES IN TEXT
Sections 300l–2, 300l–4, and 300n–4 of this title, referred
to in subsec. (a), were repealed effective Jan. 1, 1987, by
Pub. L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat.
3799.
Section 300l–1 of this title, referred to in subsec.
(a)(3), was in the original a reference to section 1512 of
act July 1, 1944, which was repealed effective Jan. 1,
1987, by Pub. L. 99–660, title VII, § 701(a), Nov. 14, 1986,
100 Stat. 3799. Pub. L. 102–531, title III, § 307, Oct. 27,
1992, 106 Stat. 3495, enacted section 1502A of act July 1,
1944, which is classified to section 300l–1 of this title.
AMENDMENTS
1979—Subsec. (d). Pub. L. 96–79 authorized appropriations of $20,000,000 for fiscal year ending Sept. 30, 1981,
and $30,000,000 for fiscal year ending Sept. 30, 1982.
1977—Subsec. (d). Pub. L. 95–83 substituted ‘‘each for
the fiscal years ending September 30, 1977, and September 30, 1978’’ for ‘‘for the fiscal year ending June 30,
1977’’.

PART E—PROGRAM TO ASSIST AND ENCOURAGE
VOLUNTARY DISCONTINUANCE OF UNNEEDED
HOSPITAL SERVICES AND CONVERSION OF UNNEEDED HOSPITAL SERVICES TO OTHER HEALTH
SERVICES NEEDED BY COMMUNITY
AMENDMENTS
1979—Pub. L. 96–79, title II, § 202(a), title III, § 301(a),
Oct. 4, 1979, 93 Stat. 632, 636, added part E relating to
program to assist and encourage voluntary discontinuance of unneeded hospital services and conversion of
unneeded hospital services to other health services
needed by the community and redesignated former part
E as part C.

§ 300t–11. Grants and assistance for establishment of program
The Secretary shall, by April 1, 1980, establish
a program under which—
(1) grants and technical assistance may be
provided to hospitals in operation on October

§ 300t–12

4, 1979, (A) for the discontinuance of unneeded
hospital services, and (B) for the conversion of
unneeded hospital services to other health
services needed by the community; and
(2) grants may be provided to State Agencies
designated under section 300m(b)(3) 1 of this
title for reducing excesses in resources and facilities of hospitals.
(July 1, 1944, ch. 373, title XVI, § 1641, as added
Pub. L. 96–79, title III, § 301(a), Oct. 4, 1979, 93
Stat. 636.)
REFERENCES IN TEXT
Section 300m of this title, referred to in par. (2), was
in the original a reference to section 1521 of act July 1,
1944, which was repealed effective Jan. 1, 1987, by Pub.
L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799.
Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 410, enacted
section 1503 of act July 1, 1944, which is classified to
section 300m of this title.
UNNEEDED HOSPITAL SERVICES; STUDY AND REPORT OF
EFFECT OF ELIMINATION
Section 302 of Pub. L. 96–79, as amended by Pub. L.
96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, which
provided that the Secretary of Health and Human Services conduct a study of the effect on the elimination of
unneeded hospital services made during the two fiscal
year period ending Sept. 30, 1981, by the program authorized by this part, and not later than Jan. 1, 1982, report the results of the study to Congress, was repealed
by Pub. L. 97–414, § 9(h), Jan. 4, 1983, 96 Stat. 2064.

§ 300t–12. Grants for discontinuance and conversion
(a)

Terms and conditions; determination of
amount; authorized uses
(1) A grant to a hospital under the program
shall be subject to such terms and conditions as
the Secretary may by regulation prescribe to assure that the grant is used for the purpose for
which it was made.
(2) The amount of any such grant shall be determined by the Secretary. The recipient of such
a grant may use the grant—
(A) in the case of a grantee which discontinues the provision of all hospital services or
all inpatient hospital services or an identifiable part of a hospital facility which provides
inpatient hospital services, for the liquidation
of the outstanding debt on the facilities of the
grantee used for the provision of the services
or for the liquidation of the outstanding debt
of the grantee on such identifiable part;
(B) in the case of a grantee which in discontinuing the provision of an inpatient hospital service converts or proposes to convert
an identifiable part of a hospital facility used
in the provision of the discontinued service to
the delivery of other health services, for the
planning, development (including construction
and acquisition of equipment), and delivery of
the health service;
(C) to provide reasonable termination pay
for personnel of the grantee who will lose employment because of the discontinuance of
hospital services made by the grantee, retraining of such personnel, assisting such personnel
in securing employment, and other costs of
implementing arrangements described in subsection (c) of this section; and
1 See

References in Text note below.

§ 300t–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) for such other costs which the Secretary
determines may need to be incurred by the
grantee in discontinuing hospital services.
(b) Application; submission and approval; form;
required provisions; review by health systems agency; basis of State Agency’s recommendations; urban or rural poverty population considerations; approval by Secretary;
restrictions and special considerations
(1) No grant may be made to a hospital unless
an application therefor is submitted to and approved by the Secretary. Such an application
shall be in such form and submitted in such
manner as the Secretary may prescribe and
shall include—
(A) a description of each service to be discontinued and, if a part of a hospital is to be
discontinued or converted to another use in
connection with such discontinuance, a description of such part;
(B) an evaluation of the impact of such discontinuance and conversion on the provision
of health care in the health service area in
which such service is provided;
(C) an estimate of the change in the applicant’s costs which will result from such discontinuance and conversion; and
(D) reasonable assurance that all laborers
and mechanics employed by contractors or
subcontractors in the performance of work on
a project will be paid wages at rates not less
than those prevailing on similar construction
in the locality as determined by the Secretary
of Labor in accordance with sections 3141–3144,
3146, and 3147 of title 40, and the Secretary of
Labor shall have with respect to such labor
standards the authority and functions set
forth in Reorganization Plan Numbered 14 of
1950 (15 FR 3176; 5 U.S.C. Appendix) and section
3145 of title 40;
(E) such other information as the Secretary
may require.
(2)(A) The health systems agency for the
health service area in which is located a hospital applying for a grant under the program
shall (i) in making the review of the applicant’s
application under section 300l–2(e) 1 of this title,
determine the need for each service or part proposed to be discontinued by the applicant, (ii) in
the case of an application for the conversion of
a facility, determine the need for each service
which will be provided as a result of the conversion, and (iii) make a recommendation to the
State Agency for the State in which the applicant is located respecting approval by the Secretary of the applicant’s application.
(B) A State Agency which has received a recommendation from a health systems agency
under subparagraph (A) respecting an application shall, after consideration of such recommendation, make a recommendation to the Secretary respecting the approval by the Secretary
of the application. A State Agency’s recommendation under this subparagraph respecting
the approval of an application (i) shall be based
upon (I) the need for each service or part proposed to be discontinued by the applicant, (II) in
the case of an application for the conversion of
1 See

References in Text note below.

Page 1064

a facility, the need for each service which will
be provided as a result of the conversion, and
(III) such other criteria as the Secretary may
prescribe, and (ii) shall be accompanied by the
health systems agency’s recommendation made
with respect to the approval of the application.
(C) In determining, under subparagraphs (A)
and (B), the need for the service (or services) or
part proposed to be discontinued or converted by
an applicant for a grant, a health systems agency and State Agency shall give special consideration to the unmet needs and existing access
patterns of urban or rural poverty populations.
(3)(A) The Secretary may not approve an application of a hospital for a grant—
(i) if a State Agency recommended that the
application not be approved, or
(ii) if the Secretary is unable to determine
that the cost of providing inpatient health
services in the health service area in which
the applicant is located will be less than if the
inpatient health services proposed to be discontinued were not discontinued.
(B) In considering applications of hospitals for
grants the Secretary shall consider the recommendations of health systems agencies and
State Agencies and shall give special consideration to applications (i) which will assist health
systems agencies and State Agencies to meet
the goals in their health systems plans and
State health plans, or (ii) which will result in
the greatest reduction in hospital costs within a
health service area.
(c) Certification of protective arrangements for
employment benefits and interests; guidelines; satisfactory arrangement determinations
(1) Except as provided in paragraph (3), the
Secretary may not approve an application submitted under subsection (b) of this section unless the Secretary of Labor has certified that
fair and equitable arrangements have been made
to protect the interests of employees affected by
the discontinuance of services against a worsening of their positions with respect to their employment, including arrangements to preserve
the rights of employees under collective-bargaining agreements, continuation of collectivebargaining rights consistent with the provisions
of the National Labor Relations Act [29 U.S.C.
151 et seq.], reassignment of affected employees
to other jobs, retraining programs, protecting
pension, health benefits, and other fringe benefits of affected employees, and arranging adequate severance pay, if necessary.
(2) The Secretary of Labor shall by regulation
prescribe guidelines for arrangements for the
protection of the interests of employees affected
by the discontinuance of hospital services. The
Secretary of Labor shall consult with the Secretary of Health and Human Services in the promulgation of such guidelines. Such guidelines
shall first be promulgated not later than the
promulgation of regulations by the Secretary
for the administration of the grants authorized
by section 300t–11 of this title.
(3) The Secretary of Labor shall review each
application submitted under subsection (b) of
this section to determine if the arrangements
described in paragraph (1) have been made and if

Page 1065

TITLE 42—THE PUBLIC HEALTH AND WELFARE

they are satisfactory and shall notify the Secretary respecting his determination. Such review shall be completed within—
(A) ninety days from the date of the receipt
of the application from the Secretary of
Health and Human Services, or
(B) one hundred and twenty days from such
date if the Secretary of Labor has by regulation prescribed the circumstances under which
the review will require at least one hundred
and twenty days.
If within the applicable period, the Secretary of
Labor does not notify the Secretary of Health
and Human Services respecting his determination, the Secretary of Health and Human Services shall review the application to determine if
the applicant has made the arrangements described in paragraph (1) and if such arrangements are satisfactory. The Secretary may not
approve the application unless he determines
that such arrangements have been made and
that they are satisfactory.
(d) Records and audits requirements
The records and audits requirements of section 292e 2 of this title shall apply with respect
to grants made under subsection (a) of this section.
(e) ‘‘Hospital’’ defined
For purposes of this part, the term ‘‘hospital’’
means, with respect to any fiscal year, an institution (including a distinct part of an institution participating in the programs established
under title XVIII of the Social Security Act [42
U.S.C. 1395 et seq.])—
(1) which satisfies paragraphs (1) and (7) of
section 1861(e) of such Act [42 U.S.C. 1395x(e)],
(2) imposes charges or accepts payments for
services provided to patients, and
(3) the average duration of a patient’s stay
in which was thirty days or less in the preceding fiscal year,
but such term does not include a Federal hospital or a psychiatric hospital (as described in
section 1861(f)(1) of the Social Security Act [42
U.S.C. 1395x(f)(1)]).
(July 1, 1944, ch. 373, title XVI, § 1642, as added
Pub. L. 96–79, title III, § 301(a), Oct. 4, 1979, 93
Stat. 637; amended Pub. L. 96–88, title V, § 509(b),
Oct. 17, 1979, 93 Stat. 695.)
REFERENCES IN TEXT
Section 300l–2, of this title, referred to in subsec.
(b)(2)(A), was repealed effective Jan. 1, 1987, by Pub. L.
99–660, title VII, § 701(a), Nov. 14, 1986, 100 Stat. 3799.
The National Labor Relations Act, referred to in subsec. (c)(1), is act July 5, 1935, ch. 372, 49 Stat. 452, as
amended, which is classified generally to subchapter II
(§ 151 et seq.) of chapter 7 of Title 29, Labor. For complete classification of this Act to the Code, see section
167 of Title 29 and Tables.
Section 292e of this title, referred to in subsec. (d),
was in the original a reference to section 705 of act July
1, 1944. Section 705 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 705 of act July 1, 1944, relating to eligibility of borrowers and terms of insured
loans, and a new section 706, relating to certificates of
2 See

References in Text note below.

§ 300t–13

loan insurance, which are classified to sections 292d and
292e, respectively, of this title.
The Social Security Act, referred to in subsec. (e), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title
XVIII of the Social Security Act is classified generally
to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
CODIFICATION
In subsec. (b)(1)(D), ‘‘sections 3141–3144, 3146, and 3147
of title 40’’ substituted for ‘‘the Act of March 3, 1931 (40
U.S.C. 276a—276a–5, known as the Davis-Bacon Act)’’
and ‘‘section 3145 of title 40’’ substituted for ‘‘section 2
of the Act of June 13, 1934 (40 U.S.C. 276c)’’ on authority
of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116 Stat. 1303, the
first section of which enacted Title 40, Public Buildings, Property, and Works.
CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (c)(2) and (3), pursuant to section 509(b)
of Pub. L. 96–88 which is classified to section 3508(b) of
Title 20, Education.

§ 300t–13. Grants to States for reduction of excess
hospital capacity
(a) ‘‘Excess hospital capacity’’ defined; particular
activities
For the purpose of demonstrating the effectiveness of various means for reducing excesses
in resources and facilities of hospitals (referred
to in this section as ‘‘excess hospital capacity’’),
the Secretary may make grants to State Agencies designated under section 300m(b)(3) 1 of this
title to assist such Agencies in—
(1) identifying (by geographic region or by
health service) excess hospital capacity,
(2) developing programs to inform the public
of the costs associated with excess hospital capacity,
(3) developing programs to reduce excess
hospital capacity in a manner which will
produce the greatest savings in the cost of
health care delivery,
(4) developing means to overcome barriers to
the reduction of excess hospital capacity,
(5) in planning, evaluating, and carrying out
programs to decertify health care facilities
providing health services that are not appropriate, and
(6) any other activity related to the reduction of excess hospital capacity.
(b) Terms and conditions
Grants under subsection (a) of this section
shall be made on such terms and conditions as
the Secretary may prescribe.
(July 1, 1944, ch. 373, title XVI, § 1643, as added
Pub. L. 96–79, title III, § 301(a), Oct. 4, 1979, 93
Stat. 639.)
REFERENCES IN TEXT
Section 300m of this title, referred to in subsec. (a),
was in the original a reference to section 1521 of act
July 1, 1944, which was repealed effective Jan. 1, 1987,
by Pub. L. 99–660, title VII, § 701(a), Nov. 14, 1986, 100
Stat. 3799. Pub. L. 101–354, § 2, Aug. 10, 1990, 104 Stat. 410,
enacted section 1503 of act July 1, 1944, which is classified to section 300m of this title.
1 See

References in Text note below.

§ 300t–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300t–14. Authorization of appropriations
To make payments under grants under sections 300t–12 and 300t–13 of this title there are
authorized to be appropriated $30,000,000 for the
fiscal year ending September 30, 1980, $50,000,000
for the fiscal year ending September 30, 1981, and
$75,000,000 for the fiscal year ending September
30, 1982, except that in any fiscal year not more
than 10 percent of the amount appropriated
under this section may be obligated for grants
under section 300t–13 of this title.
(July 1, 1944, ch. 373, title XVI, § 1644, as added
Pub. L. 96–79, title III, § 301(a), Oct. 4, 1979, 93
Stat. 640.)
SUBCHAPTER XV—HEALTH INFORMATION
AND HEALTH PROMOTION
§ 300u. General authority of Secretary
(a) Development, support, and implementation of
programs, activities, etc.
The Secretary shall—
(1) formulate national goals, and a strategy
to achieve such goals, with respect to health
information and health promotion, preventive
health services, and education in the appropriate use of health care;
(2) analyze the necessary and available resources for implementing the goals and strategy formulated pursuant to paragraph (1), and
recommend appropriate educational and quality assurance policies for the needed manpower resources identified by such analysis;
(3) undertake and support necessary activities and programs to—
(A) incorporate appropriate health education components into our society, especially into all aspects of education and
health care,
(B) increase the application and use of
health knowledge, skills, and practices by
the general population in its patterns of
daily living, and
(C) establish systematic processes for the
exploration, development, demonstration,
and evaluation of innovative health promotion concepts;
(4) undertake and support research and demonstrations respecting health information and
health promotion, preventive health services,
and education in the appropriate use of health
care;
(5) undertake and support appropriate training in, and undertake and support appropriate
training in the operation of programs concerned with, health information and health
promotion, preventive health services, and
education in the appropriate use of health
care;
(6) undertake and support, through improved
planning and implementation of tested models
and evaluation of results, effective and efficient programs respecting health information
and health promotion, preventive health services, and education in the appropriate use of
health care;
(7)(A) develop model programs through
which employers in the public sector, and employers that are small businesses (as defined

Page 1066

in section 632 of title 15), can provide for their
employees a program to promote healthy behaviors and to discourage participation in unhealthy behaviors;
(B) provide technical assistance to public
and private employers in implementing such
programs (including private employers that
are not small businesses and that will implement programs other than the programs developed by the Secretary pursuant to subparagraph (A)); and
(C) in providing such technical assistance,
give preference to small businesses;
(8) foster the exchange of information respecting, and foster cooperation in the conduct of, research, demonstration, and training
programs respecting health information and
health promotion, preventive health services,
and education in the appropriate use of health
care;
(9) provide technical assistance in the programs referred to in paragraph (8);
(10) use such other authorities for programs
respecting health information and health promotion, preventive health services, and education in the appropriate use of health care as
are available and coordinate such use with
programs conducted under this subchapter;
and
(11) establish in the Office of the Assistant
Secretary for Health an Office of Disease Prevention and Health Promotion, which shall—
(A) coordinate all activities within the Department which relate to disease prevention,
health promotion, preventive health services, and health information and education
with respect to the appropriate use of health
care;
(B) coordinate such activities with similar
activities in the private sector;
(C) establish a national information clearinghouse to facilitate the exchange of information concerning matters relating to
health information and health promotion,
preventive health services (which may include information concerning models and
standards for insurance coverage of such
services), and education in the appropriate
use of health care, to facilitate access to
such information, and to assist in the analysis of issues and problems relating to such
matters; and
(D) support projects, conduct research, and
disseminate information relating to preventive medicine, health promotion, and physical fitness and sports medicine.
The Secretary shall appoint a Director for the
Office of Disease Prevention and Health Promotion established pursuant to paragraph (11) of
this subsection. The Secretary shall administer
this subchapter in cooperation with health care
providers, educators, voluntary organizations,
businesses, and State and local health agencies
in order to encourage the dissemination of
health information and health promotion activities.
(b) Authorization of appropriations
For the purpose of carrying out this section
and sections 300u–1 through 300u–4 of this title,
there are authorized to be appropriated

Page 1067

TITLE 42—THE PUBLIC HEALTH AND WELFARE

$10,000,000 for fiscal year 1992, and such sums as
may be necessary for each of the fiscal years
1993 through 2002.
(c) Application; submission and approval as prerequisite; form and content
No grant may be made or contract entered
into under this subchapter unless an application
therefor has been submitted to and approved by
the Secretary. Such an application shall be submitted in such form and manner and contain
such information as the Secretary may prescribe. Contracts may be entered into under this
subchapter without regard to section 3324(a) and
(b) of title 31 and section 6101 of title 41.
(July 1, 1944, ch. 373, title XVII, § 1701, as added
Pub. L. 94–317, title I, § 102, June 23, 1976, 90 Stat.
695; amended Pub. L. 96–32, § 7(n), July 10, 1979, 93
Stat. 85; Pub. L. 96–76, title II, § 209, Sept. 29,
1979, 93 Stat. 584; Pub. L. 98–551, § 2(a), Oct. 30,
1984, 98 Stat. 2815; Pub. L. 100–607, title III,
§ 312(a)(1), (b)(1), (c), Nov. 4, 1988, 102 Stat. 3113,
3114; Pub. L. 102–168, title I, § 101, Nov. 26, 1991,
105 Stat. 1102; Pub. L. 102–531, title III, § 311(b)(1),
Oct. 27, 1992, 106 Stat. 3503; Pub. L. 105–392, title
IV, § 414, Nov. 13, 1998, 112 Stat. 3590.)

§ 300u

‘‘and with health planning and resource development
activities undertaken under subchapters XIII and XIV
of this chapter’’ after ‘‘section 300k–2 of this title’’ and
inserted provisions for appointment of a Director for
Office of Disease Prevention and Health Promotion and
cooperation in administration of this subchapter.
Subsec. (b). Pub. L. 98–551, § 2(a)(2), substituted ‘‘To
carry out this subchapter, there are authorized to be
appropriated $9,000,000 for the fiscal year ending September 30, 1985, $9,500,000 for the fiscal year ending September 30, 1986, and $10,000,000 for the fiscal year ending
September 30, 1987’’ for ‘‘For payments under grants
and contracts under this subchapter (other than grants
and contracts under sections 300u–6, 300u–7, and 300u–8
of this title) there are authorized to be appropriated
$7,000,000 for the fiscal year ending September 30, 1977,
$10,000,000 for the fiscal year ending September 30, 1978,
$14,000,000 for the fiscal year ending September 30, 1979,
$14,000,000 for the fiscal year ending September 30, 1980,
$15,000,000 for the fiscal year ending September 30, 1981,
and $16,000,000 for the fiscal year ending September 30,
1982.’’
1979—Subsec. (b). Pub. L. 96–76 inserted provisions authorizing appropriations for fiscal years ending Sept.
30, 1980, Sept. 30, 1981, and Sept. 30, 1982.
Pub. L. 96–32 inserted ‘‘(other than grants and contracts under sections 300u–6, 300u–7, and 300u–8 of this
title)’’ after ‘‘grants and contracts under this subchapter’’.

CODIFICATION

SHORT TITLE

In subsec. (c), ‘‘section 3324(a) and (b) of title 31 and
section 6101 of title 41’’ substituted for ‘‘sections 3648
and 3709 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C.
5)’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13, 1982,
96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat.
3854, which Act enacted Title 41, Public Contracts.

For short title of title I of Pub. L. 94–317, which enacted this subchapter as the ‘‘National Consumer
Health Information and Health Promotion Act of 1976’’,
see section 101 of Pub. L. 94–317, set out as a Short Title
of 1976 Amendments note under section 201 of this title.

AMENDMENTS

Section 312(b)(2) of Pub. L. 100–607 required Secretary
of Health and Human Services, not later than 18
months after Nov. 4, 1988, to complete development of
model programs required in section 1701(a)(7)(A) of the
Public Health Service Act (subsec. (a)(7)(A) of this section).

1998—Subsec. (b). Pub. L. 105–392 substituted ‘‘2002’’
for ‘‘1996’’.
1992—Subsec. (a)(11)(C). Pub. L. 102–531 substituted
‘‘preventive health services (which may include information concerning models and standards for insurance
coverage of such services),’’ for ‘‘preventive health
services,’’.
1991—Subsec. (b). Pub. L. 102–168 amended subsec. (b)
generally. Prior to amendment, subsec. (b) read as follows: ‘‘To carry out sections 300u through 300u–4 of this
title, there are authorized to be appropriated $9,000,000
for the fiscal year ending September 30, 1985, $9,500,000
for the fiscal year ending September 30, 1986, $10,000,000
for the fiscal year ending September 30, 1987, and
$10,000,000 for each of the fiscal years 1989 through
1991.’’
1988—Subsec. (a). Pub. L. 100–607, § 312(c)(2), in concluding provisions, struck out ‘‘The Secretary shall administer this subchapter in a manner consistent with
the national health priorities set forth in section 300k–2
of this title.’’ before ‘‘The Secretary shall appoint’’,
and substituted ‘‘paragraph (11)’’ for ‘‘paragraph (10)’’.
Subsec. (a)(7), (8). Pub. L. 100–607, § 312(b)(1), added
par. (7) and redesignated former par. (7) as (8). Former
par. (8) redesignated (9).
Subsec. (a)(9). Pub. L. 100–607, § 312(c)(1), substituted
‘‘paragraph (8)’’ for ‘‘paragraph (7)’’.
Pub. L. 100–607, § 312(b)(1)(A), redesignated par. (8) as
(9). Former par. (9) redesignated (10).
Subsec. (a)(10), (11). Pub. L. 100–607, § 312(b)(1)(A), redesignated pars. (9) and (10) as (10) and (11), respectively.
Subsec. (b). Pub. L. 100–607, § 312(a)(1), substituted
‘‘sections 300u through 300u–4 of this title’’ for ‘‘this
subchapter’’, struck out ‘‘and’’ after ‘‘September 30,
1986,’’, and inserted ‘‘, and $10,000,000 for each of the fiscal years 1989 through 1991’’.
1984—Subsec. (a). Pub. L. 98–551, § 2(a)(1), added par.
(10), and in provisions following par. (10) struck out

MODEL PROGRAMS FOR EMPLOYEE HEALTH PROMOTION
AND DISEASE PREVENTION; DEVELOPMENT COMPLETION

EXECUTIVE ORDER NO. 12345
Ex. Ord. No. 12345, Feb. 2, 1982, 47 F.R. 5189, as amended by Ex. Ord. No. 12539, Dec. 3, 1985, 50 F.R. 49829; Ex.
Ord. No. 12694, Oct. 11, 1989, 54 F.R. 42285; Ex. Ord. No.
12709, Apr. 4, 1990, 55 F.R. 13097; Ex. Ord. No. 13138, § 8,
Sept. 30, 1999, 64 F.R. 53881, which provided for the Secretary of Health and Human Services to develop and
coordinate a national program for physical fitness and
sports, continued the President’s Council on Physical
Fitness and Sports, and provided for termination of the
Council on Dec. 31, 1982, was revoked by Ex. Ord. No.
13265, § 5(c), June 6, 2002, 67 F.R. 39842, set out below,
prior to amendment by Ex. Ord. No. 13545, June 22, 2010,
75 F.R. 37283.
EX. ORD. NO. 13265. PRESIDENT’S COUNCIL ON FITNESS,
SPORTS, AND NUTRITION
Ex. Ord. No. 13265, June 6, 2002, 67 F.R. 39841, as
amended by Ex. Ord. No. 13545, June 22, 2010, 75 F.R.
37283, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, and to expand the executive branch’s program
for physical fitness and sports and establish the President’s Council on Physical Fitness and Sports [probably should be ‘‘President’s Council on Fitness, Sports,
and Nutrition’’] (the ‘‘Council’’), it is hereby ordered as
follows:
SECTION 1. Purpose. The Secretary of Health and
Human Services (Secretary), in carrying out the Secretary’s responsibilities for public health and human
services, shall develop and coordinate a national program to enhance physical activity, fitness, sports par-

§ 300u

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ticipation, and good nutrition. Through this program,
the Secretary shall, in consultation with the Secretaries of Agriculture and Education, seek to:
(a) expand national interest in and awareness of the
benefits of regular physical activity, fitness, sports participation, and good nutrition;
(b) stimulate and enhance coordination of programs
within and among the private and public sectors that
promote physical activity, fitness, sports participation,
and good nutrition;
(c) expand availability of quality information and
guidance regarding physical activity, fitness, sports
participation, and good nutrition; and
(d) target all Americans, with particular emphasis on
children and adolescents, as well as populations or
communities in which specific risks or disparities in
participation in, access to, or knowledge about the benefits of physical activity, fitness, sports participation,
and good nutrition have been identified.
In implementing this order, the Secretary shall be
guided by the science-based Federal Dietary Guidelines
for Americans and the Physical Activity Guidelines for
Americans. Additionally, the Secretary shall undertake nutrition-related activities under this order in coordination with the Secretary of Agriculture.
SEC. 2. The President’s Council on Fitness, Sports, and
Nutrition. (a) There is hereby established the President’s Council on Fitness, Sports, and Nutrition (Council).
(b) The Council shall be composed of up to 25 members appointed by the President. Members shall serve
for a term of 2 years, shall be eligible for reappointment, and may continue to serve after the expiration of
their terms until the appointment of a successor. The
President may designate one or more members as Chair
or Vice Chair.
SEC. 3. Functions of the Council. (a) The Council shall
advise the President, through the Secretary, concerning progress made in carrying out the provisions of this
order and shall recommend to the President, through
the Secretary, actions to accelerate progress.
(b) The Council shall advise the Secretary on ways to
promote regular physical activity, fitness, sports participation, and good nutrition. Recommendations may
address, but are not necessarily limited to, public
awareness campaigns; Federal, State, and local physical activity; fitness, sports participation, and nutrition initiatives; and partnership opportunities between
public- and private-sector health-promotion entities.
(c) The Council shall function as a liaison to relevant
State, local, and private entities in order to advise the
Secretary regarding opportunities to extend and improve physical activity, fitness, sports, and nutrition
programs and services at the local, State, and national
levels.
(d) The Council shall monitor the need to enhance
programs and educational and promotional materials
sponsored, overseen, or disseminated by the Council,
and shall advise the Secretary as necessary concerning
such need.
In performing its functions, the Council shall take
into account the Federal Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
SEC. 4. Administration. (a) Each executive department
and agency shall, to the extent permitted by law and
subject to the availability of funds, furnish such information and assistance to the Secretary and the Council
as they may request.
(b) The members of the Council shall serve without
compensation for their work on the Council. Members
of the Council may, however, receive travel expenses,
including per diem in lieu of subsistence, as authorized
by law for persons serving intermittently in Government service (5 U.S.C. 5701–5707).
(c) To the extent permitted by law, the Secretary
shall furnish the Council with necessary staff, supplies,
facilities, and other administrative services. The expenses of the Council shall be paid from funds available
to the Secretary.

Page 1068

(d) The Secretary shall appoint an Executive Director
of the Council who shall serve as a liaison to the Secretary and the White House on matters and activities
pertaining to the Council.
(e) The Council, with the approval of the Secretary,
may establish subcommittees as appropriate to aid in
its work.
(f) The seal prescribed by Executive Order 10830 of
July 24, 1959, as amended, shall be modified to reflect
the name of the Council as established by this order.
SEC. 5. General Provisions. (a) Insofar as the Federal
Advisory Committee Act, as amended (5 U.S.C. App.)
(Act), may apply to the administration of any portion
of this order, any functions of the President under the
Act, except that of reporting to the Congress, shall be
performed by the Secretary in accordance with the
guidelines and procedures issued by the Administrator
of General Services.
(b) The Council shall terminate 2 years from the date
of this order, unless extended by the President.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
EXTENSION OF TERM OF PRESIDENT’S COUNCIL ON
PHYSICAL FITNESS AND SPORTS
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1984, by Ex. Ord. No.
12399, Dec. 31, 1982, 48 F.R. 379, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5, Government Organization and Employees.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1985, by Ex. Ord. No.
12489, Sept. 28, 1984, 49 F.R. 38927, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1987, by Ex. Ord. No.
12534, Sept. 30, 1985, 50 F.R. 40319, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1989, by Ex. Ord. No.
12610, Sept. 30, 1987, 52 F.R. 36901, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1991, by Ex. Ord. No.
12692, Sept. 29, 1989, 54 F.R. 40627, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1993, by Ex. Ord. No.
12774, Sept. 27, 1991, 56 F.R. 49835, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1995, by Ex. Ord. No.
12869, Sept. 30, 1993, 58 F.R. 51751, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1997, by Ex. Ord. No.
12974, Sept. 29, 1995, 60 F.R. 51875, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 1999, by Ex. Ord. No.
13062, Sept. 29, 1997, 62 F.R. 51755, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2001, by Ex. Ord. No.
13138, Sept. 30, 1999, 64 F.R. 53879, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2003, by Ex. Ord. No.

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13225, Sept. 28, 2001, 66 F.R. 50291, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2005, by Ex. Ord. No.
13316, Sept. 17, 2003, 68 F.R. 55255, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2007, by Ex. Ord. No.
13385, Sept. 29, 2005, 70 F.R. 57989, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2009, by Ex. Ord. No.
13446, Sept. 28, 2007, 72 F.R. 56175, formerly set out as a
note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5.
Term of the President’s Council on Physical Fitness
and Sports extended until Sept. 30, 2011, by Ex. Ord. No.
13511, Sept. 29, 2009, 74 F.R. 50909, set out as a note
under section 14 of the Federal Advisory Committee
Act in the Appendix to Title 5.
EX. ORD. NO. 13266. ACTIVITIES TO PROMOTE PERSONAL
FITNESS
Ex. Ord. No. 13266, June 20, 2002, 67 F.R. 42467, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, and in order to improve the efficiency and coordination of Federal policies related to personal fitness of the general public, it is hereby ordered as follows:
SECTION 1. Policy. This order is issued consistent with
the following findings and principles:
(a) Growing scientific evidence indicates that an increasing number of Americans are suffering from negligible physical activity, poor dietary habits, insufficient utilization of preventive health screenings, and
engaging in risky behaviors such as abuse of alcohol,
tobacco, and drugs.
(b) Existing information on the importance of appropriate physical activity, diet, preventive health screenings, and avoiding harmful substances is often not received by the public, or, if received, is not acted on sufficiently.
(c) Individuals of all ages, locations, and levels of personal fitness can benefit from some level of appropriate
physical activity, dietary guidance, preventive health
screening, and making healthy choices.
(d) While personal fitness is an individual responsibility, the Federal Government may, within the authority
and funds otherwise available, expand the opportunities
for individuals to empower themselves to improve their
general health. Such opportunities may include improving the flow of information about personal fitness,
assisting in the utilization of that information, increasing the accessibility of resources for physical activity, and reducing barriers to achieving good personal
fitness.
SEC. 2. Agency Responsibilities in Promoting Personal
Fitness.
(a) The Secretaries of Agriculture, Education, Health
and Human Services (HHS), Housing and Urban Development, Interior, Labor, Transportation, and Veterans
Affairs, and the Director of the Office of National Drug
Policy shall review and evaluate the policies, programs, and regulations of their respective departments
and offices that in any way relate to the personal fitness of the general public. Based on that review, the
Secretaries and the Director shall determine whether
existing policies, programs, and regulations of their respective departments and offices should be modified or
whether new policies or programs could be implemented. These new policies and programs shall be consistent with otherwise available authority and appropriated funds, and shall improve the Federal Government’s assistance of individuals, private organizations,
and State and local governments to (i) increase phys-

§ 300u

ical activity; (ii) promote responsible dietary habits;
(iii) increase utilization of preventive health screenings; and (iv) encourage healthy choices concerning alcohol, tobacco, drugs, and safety among the general
public.
(b) Each department and office included in section
2(a) shall report to the President, through the Secretary of Health and Human Services, its proposed actions within 90 days of the date of this order.
(c) There shall be a Personal Fitness Interagency
Working Group (Working Group), composed of the Secretaries or Director of the departments and office included in section 2(a) (or their designees) and chaired
by the Secretary of HHS or his designee. In order to improve efficiency through information sharing and to
eliminate waste and overlap, the Working Group shall
work to ensure the cooperation of Federal agencies in
coordinating Federal personal fitness activities. The
Working Group shall meet subject to the call of the
Chair, but not less than twice a year. The Department
of Health and Human Services shall provide such administrative support to the Working Group as the Secretary of HHS deems necessary. Each member of the
Working Group shall be a full-time or permanent parttime officer or employee of the Federal Government.
SEC. 3. General Provisions. This order is intended only
to improve the internal management of the executive
branch and it is not intended to, and does not, create
any right, benefit, trust, or responsibility, substantive
or procedural, enforceable at law or equity by a party
against the United States, its departments, agencies or
entities, its officers or employees, or any person.
GEORGE W. BUSH.
EX. ORD. NO. 13335. INCENTIVES FOR THE USE OF HEALTH
INFORMATION TECHNOLOGY AND ESTABLISHING THE POSITION OF THE NATIONAL HEALTH INFORMATION TECHNOLOGY COORDINATOR
Ex. Ord. No. 13335, Apr. 27, 2004, 69 F.R. 24059, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, and to provide leadership for the development
and nationwide implementation of an interoperable
health information technology infrastructure to improve the quality and efficiency of health care, it is
hereby ordered as follows:
SECTION 1. Establishment. (a) The Secretary of Health
and Human Services (Secretary) shall establish within
the Office of the Secretary the position of National
Health Information Technology Coordinator.
(b) The National Health Information Technology Coordinator (National Coordinator), appointed by the
Secretary in consultation with the President or his designee, will report directly to the Secretary.
(c) The Secretary shall provide the National Coordinator with appropriate staff, administrative support, and other resources to meet its responsibilities
under this order.
(d) The Secretary shall ensure that the National Coordinator begins operations within 90 days of the date
of this order.
SEC. 2. Policy. In fulfilling its responsibilities, the
work of the National Coordinator shall be consistent
with a vision of developing a nationwide interoperable
health information technology infrastructure that:
(a) Ensures that appropriate information to guide
medical decisions is available at the time and place of
care;
(b) Improves health care quality, reduces medical errors, and advances the delivery of appropriate, evidence-based medical care;
(c) Reduces health care costs resulting from inefficiency, medical errors, inappropriate care, and incomplete information;
(d) Promotes a more effective marketplace, greater
competition, and increased choice through the wider
availability of accurate information on health care
costs, quality, and outcomes;

§ 300u

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Improves the coordination of care and information
among hospitals, laboratories, physician offices, and
other ambulatory care providers through an effective
infrastructure for the secure and authorized exchange
of health care information; and
(f) Ensures that patients’ individually identifiable
health information is secure and protected.
SEC. 3. Responsibilities of the National Health Information Technology Coordinator. (a) The National Coordinator shall, to the extent permitted by law, develop,
maintain, and direct the implementation of a strategic
plan to guide the nationwide implementation of interoperable health information technology in both the
public and private health care sectors that will reduce
medical errors, improve quality, and produce greater
value for health care expenditures. The National Coordinator shall report to the Secretary regarding
progress on the development and implementation of
the strategic plan within 90 days after the National Coordinator begins operations and periodically thereafter.
The plan shall:
(i) Advance the development, adoption, and implementation of health care information technology
standards nationally through collaboration among
public and private interests, and consistent with current efforts to set health information technology
standards for use by the Federal Government;
(ii) Ensure that key technical, scientific, economic,
and other issues affecting the public and private
adoption of health information technology are addressed;
(iii) Evaluate evidence on the benefits and costs of
interoperable health information technology and assess to whom these benefits and costs accrue;
(iv) Address privacy and security issues related to
interoperable health information technology and recommend methods to ensure appropriate authorization, authentication, and encryption of data for
transmission over the Internet;
(v) Not assume or rely upon additional Federal resources or spending to accomplish adoption of interoperable health information technology; and
(vi) Include measurable outcome goals.
(b) The National Coordinator shall:
(i) Serve as the Secretary’s principal advisor on the
development, application, and use of health information technology, and direct the Department of Health
and Human Service’s health information technology
programs;
(ii) Ensure that health information technology policy and programs of the Department of Health and
Human Services (HHS) are coordinated with those of
relevant executive branch agencies (including Federal commissions) with a goal of avoiding duplication
of efforts and of helping to ensure that each agency
undertakes activities primarily within the areas of
its greatest expertise and technical capability;
(iii) To the extent permitted by law, coordinate
outreach and consultation by the relevant executive
branch agencies (including Federal commissions)
with public and private parties of interest, including
consumers, providers, payers, and administrators;
and
(iv) At the request of the Office of Management and
Budget, provide comments and advice regarding specific Federal health information technology programs.
SEC. 4. Reports. To facilitate the development of
interoperable health information technologies, the Secretary of Health and Human Services shall report to
the President within 90 days of this order on options to
provide incentives in HHS programs that will promote
the adoption of interoperable health information technology. In addition, the following reports shall be submitted to the President through the Secretary:
(a) The Director of the Office of Personnel Management shall report within 90 days of this order on options to provide incentives in the Federal Employee
Health Benefit Program that will promote the adoption
of interoperable health information technology; and

Page 1070

(b) Within 90 days, the Secretary of Veterans Affairs
and the Secretary of Defense shall jointly report on the
approaches the Departments could take to work more
actively with the private sector to make their health
information systems available as an affordable option
for providers in rural and medically underserved communities.
SEC. 5. Administration and Judicial Review. (a) The actions directed by this order shall be carried out subject
to the availability of appropriations and to the extent
permitted by law.
(b) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity against the United States, its
agencies, its entities or instrumentalities, its officers
or employees, or any other person.
GEORGE W. BUSH.
EX. ORD. NO. 13410. PROMOTING QUALITY AND EFFICIENT
HEALTH CARE IN FEDERAL GOVERNMENT ADMINISTERED
OR SPONSORED HEALTH CARE PROGRAMS
Ex. Ord. No. 13410, Aug. 22, 2006, 71 F.R. 51089, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States, and in
order to promote federally led efforts to implement
more transparent and high-quality health care, it is
hereby ordered as follows:
SECTION 1. Purpose. It is the purpose of this order to
ensure that health care programs administered or sponsored by the Federal Government promote quality and
efficient delivery of health care through the use of
health information technology, transparency regarding
health care quality and price, and better incentives for
program beneficiaries, enrollees, and providers. It is
the further purpose of this order to make relevant information available to these beneficiaries, enrollees,
and providers in a readily useable manner and in collaboration with similar initiatives in the private sector
and non-Federal public sector. Consistent with the purpose of improving the quality and efficiency of health
care, the actions and steps taken by Federal Government agencies should not incur additional costs for the
Federal Government.
SEC. 2. Definitions. For purposes of this order:
(a) ‘‘Agency’’ means an agency of the Federal Government that administers or sponsors a Federal health
care program.
(b) ‘‘Federal health care program’’ means the Federal
Employees Health Benefit Program, the Medicare program, programs operated directly by the Indian Health
Service, the TRICARE program for the Department of
Defense and other uniformed services, and the health
care program operated by the Department of Veterans
Affairs. For purposes of this order, ‘‘Federal health
care program’’ does not include State operated or funded federally subsidized programs such as Medicaid, the
State Children’s Health Insurance Program, or services
provided to Department of Veterans’ Affairs beneficiaries under 38 U.S.C. 1703.
(c) ‘‘Interoperability’’ means the ability to communicate and exchange data accurately, effectively, securely, and consistently with different information
technology systems, software applications, and networks in various settings, and exchange data such that
clinical or operational purpose and meaning of the data
are preserved and unaltered.
(d) ‘‘Recognized interoperability standards’’ means
interoperability standards recognized by the Secretary
of Health and Human Services (the ‘‘Secretary’’), in accordance with guidance developed by the Secretary, as
existing on the date of the implementation, acquisition, or upgrade of health information technology systems under subsections (1) or (2) of section 3(a) of this
order.
SEC. 3. Directives for Agencies. Agencies shall perform
the following functions:
(a) Health Information Technology.
(1) For Federal Agencies. As each agency implements,
acquires, or upgrades health information technology

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

systems used for the direct exchange of health information between agencies and with non-Federal entities, it
shall utilize, where available, health information technology systems and products that meet recognized
interoperability standards.
(2) For Contracting Purposes. Each agency shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as
each provider, plan, or issuer implements, acquires, or
upgrades health information technology systems, it
shall utilize, where available, health information technology systems and products that meet recognized
interoperability standards.
(b) Transparency of Quality Measurements.
(1) In General. Each agency shall implement programs measuring the quality of services supplied by
health care providers to the beneficiaries or enrollees
of a Federal health care program. Such programs shall
be based upon standards established by multi-stakeholder entities identified by the Secretary or by another agency subject to this order. Each agency shall
develop its quality measurements in collaboration with
similar initiatives in the private and non-Federal public sectors.
(2) Facilitation. An agency satisfies the requirements
of this subsection if it participates in the aggregation
of claims and other appropriate data for the purposes of
quality measurement. Such aggregation shall be based
upon standards established by multi-stakeholder entities identified by the Secretary or by another agency
subject to this order.
(c) Transparency of Pricing Information. Each agency shall make available (or provide for the availability)
to the beneficiaries or enrollees of a Federal health
care program (and, at the option of the agency, to the
public) the prices that it, its health insurance issuers,
or its health insurance plans pay for procedures to providers in the health care program with which the agency, issuer, or plan contracts. Each agency shall also, in
collaboration with multi-stakeholder groups such as
those described in subsection (b)(1), participate in the
development of information regarding the overall costs
of services for common episodes of care and the treatment of common chronic diseases.
(d) Promoting Quality and Efficiency of Care. Each
agency shall develop and identify, for beneficiaries, enrollees, and providers, approaches that encourage and
facilitate the provision and receipt of high-quality and
efficient health care. Such approaches may include
pay-for-performance models of reimbursement consistent with current law. An agency will satisfy the requirements of this subsection if it makes available to
beneficiaries or enrollees consumer-directed health
care insurance products.
SEC. 4. Implementation Date. Agencies shall comply
with the requirements of this order by January 1, 2007.
SEC. 5. Administration and Judicial Review.
(a) This order does not assume or rely upon additional Federal resources or spending to promote quality and efficient health care. Further, the actions directed by this order shall be carried out subject to the
availability of appropriations and to the maximum extent permitted by law.
(b) This order shall be implemented in new contracts
or new contract cycles as they may be renewed from
time to time. Renegotiation outside of the normal contract cycle processes should be avoided.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity against the United States, its
departments, agencies, or entities, its officers, employees, or agents, or any other person.
GEORGE W. BUSH.

§ 300u–1. Grants and contracts for research programs; authority of Secretary; review of applications; additional functions; periodic
public survey
(a) The Secretary is authorized to conduct and
support by grant or contract (and encourage

§ 300u–1

others to support) research in health information and health promotion, preventive health
services, and education in the appropriate use of
health care. Applications for grants and contracts under this section shall be subject to appropriate peer review. The Secretary shall also—
(1) provide consultation and technical assistance to persons who need help in preparing research proposals or in actually conducting research;
(2) determine the best methods of disseminating information concerning personal health
behavior, preventive health services and the
appropriate use of health care and of affecting
behavior so that such information is applied
to maintain and improve health, and prevent
disease, reduce its risk, or modify its course or
severity;
(3) determine and study environmental, occupational, social, and behavioral factors
which affect and determine health and ascertain those programs and areas for which educational and preventive measures could be implemented to improve health as it is affected
by such factors;
(4) develop (A) methods by which the cost
and effectiveness of activities respecting
health information and health promotion, preventive health services, and education in the
appropriate use of health care, can be measured, including methods for evaluating the effectiveness of various settings for such activities and the various types of persons engaged
in such activities, (B) methods for reimbursement or payment for such activities, and (C)
models and standards for the conduct of such
activities, including models and standards for
the education, by providers of institutional
health services, of individuals receiving such
services respecting the nature of the institutional health services provided the individuals
and the symptoms, signs, or diagnoses which
led to provision of such services;
(5) develop a method for assessing the cost
and effectiveness of specific medical services
and procedures under various conditions of
use, including the assessment of the sensitivity and specificity of screening and diagnostic
procedures; and
(6) enumerate and assess, using methods developed under paragraph (5), preventive health
measures and services with respect to their
cost and effectiveness under various conditions of use (which measures and services may
include blood pressure screening, cholesterol
screening and control, smoking cessation programs, substance abuse programs, cancer
screening, dietary and nutritional counseling,
diabetes screening and education, intraocular
pressure screening, and stress management).
(b) The Secretary shall make a periodic survey
of the needs, interest, attitudes, knowledge, and
behavior of the American public regarding
health and health care. The Secretary shall take
into consideration the findings of such surveys
and the findings of similar surveys conducted by
national and community health education organizations, and other organizations and agencies
for formulating policy respecting health information and health promotion, preventive health
services, and education in the appropriate use of
health care.

§ 300u–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XVII, § 1702, as added
Pub. L. 94–317, title I, § 102, June 23, 1976, 90 Stat.
696; amended Pub. L. 102–531, title III, § 311(b)(2),
Oct. 27, 1992, 106 Stat. 3504.)
AMENDMENTS
1992—Subsec. (a)(6). Pub. L. 102–531 inserted before period ‘‘(which measures and services may include blood
pressure screening, cholesterol screening and control,
smoking cessation programs, substance abuse programs, cancer screening, dietary and nutritional counseling, diabetes screening and education, intraocular
pressure screening, and stress management)’’.

§ 300u–2. Grants and contracts for community
health programs
(a) Authority of Secretary; particular activities
The Secretary is authorized to conduct and
support by grant or contract (and encourage
others to support) new and innovative programs
in health information and health promotion,
preventive health services, and education in the
appropriate use of health care, and may specifically—
(1) support demonstration and training programs in such matters which programs (A) are
in hospitals, ambulatory care settings, home
care settings, schools, day care programs for
children, and other appropriate settings representative of broad cross sections of the population, and include public education activities of voluntary health agencies, professional
medical societies, and other private nonprofit
health organizations, (B) focus on objectives
that are measurable, and (C) emphasize the
prevention or moderation of illness or accidents that appear controllable through individual knowledge and behavior;
(2) provide consultation and technical assistance to organizations that request help in
planning, operating, or evaluating programs in
such matters;
(3) develop health information and health
promotion materials and teaching programs
including (A) model curriculums for the training of educational and health professionals
and paraprofessionals in health education by
medical, dental, and nursing schools, schools
of public health, and other institutions engaged in training of educational or health professionals, (B) model curriculums to be used in
elementary and secondary schools and institutions of higher learning, (C) materials and programs for the continuing education of health
professionals and paraprofessionals in the
health education of their patients, (D) materials for public service use by the printed and
broadcast media, and (E) materials and programs to assist providers of health care in providing health education to their patients; and
(4) support demonstration and evaluation
programs for individual and group self-help
programs designed to assist the participant in
using his individual capacities to deal with
health problems, including programs concerned with obesity, hypertension, and diabetes.

Page 1072

(b) Grants to States and other public and nonprofit private entities; costs of demonstrating
and evaluating programs; development of
models
The Secretary is authorized to make grants to
States and other public and nonprofit private
entities to assist them in meeting the costs of
demonstrating and evaluating programs which
provide information respecting the costs and
quality of health care or information respecting
health insurance policies and prepaid health
plans, or information respecting both. After the
development of models pursuant to section
300u–3(4) and 300u–3(5) of this title for such information, no grant may be made under this subsection for a program unless the information to
be provided under the program is provided in accordance with one of such models applicable to
the information.
(c) Private nonprofit entities; limitation on
amount of grant or contract
The Secretary is authorized to support by
grant or contract (and to encourage others to
support) private nonprofit entities working in
health information and health promotion, preventive health services, and education in the appropriate use of health care. The amount of any
grant or contract for a fiscal year beginning
after September 30, 1978, for an entity may not
exceed 25 per centum of the expenses of the entity for such fiscal year for health information
and health promotion, preventive health services, and education in the appropriate use of
health care.
(July 1, 1944, ch. 373, title XVII, § 1703, as added
Pub. L. 94–317, title I, § 102, June 23, 1976, 90 Stat.
697.)
§ 300u–3. Grants and contracts for information
programs; authority of Secretary; particular
activities
The Secretary is authorized to conduct and
support by grant or contract (and encourage
others to support) such activities as may be required to make information respecting health
information and health promotion, preventive
health services, and education in the appropriate use of health care available to the consumers of medical care, providers of such care,
schools, and others who are or should be informed respecting such matters. Such activities
may include at least the following:
(1) The publication of information, pamphlets, and other reports which are specially
suited to interest and instruct the health consumer, which information, pamphlets, and
other reports shall be updated annually, shall
pertain to the individual’s ability to improve
and safeguard his own health; shall include
material, accompanied by suitable illustrations, on child care, family life and human development, disease prevention (particularly
prevention of pulmonary disease, cardiovascular disease, and cancer), physical fitness,
dental health, environmental health, nutrition, safety and accident prevention, drug
abuse and alcoholism, mental health, management of chronic diseases (including diabetes
and arthritis), and venereal diseases; and shall

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

be designed to reach populations of different
languages and of different social and economic
backgrounds.
(2) Securing the cooperation of the communications media, providers of health care,
schools, and others in activities designed to
promote and encourage the use of health
maintaining information and behavior.
(3) The study of health information and promotion in advertising and the making to concerned Federal agencies and others such recommendations respecting such advertising as
are appropriate.
(4) The development of models and standards
for the publication by States, insurance carriers, prepaid health plans, and others (except
individual health practitioners) of information
for use by the public respecting the cost and
quality of health care, including information
to enable the public to make comparisons of
the cost and quality of health care.
(5) The development of models and standards
for the publication by States, insurance carriers, prepaid health plans, and others of information for use by the public respecting health
insurance policies and prepaid health plans,
including information on the benefits provided
by the various types of such policies and plans,
the premium charges for such policies and
plans, exclusions from coverage or eligibility
for coverage, cost sharing requirements, and
the ratio of the amounts paid as benefits to
the amounts received as premiums and information to enable the public to make relevant
comparisons of the costs and benefits of such
policies and plans.
(July 1, 1944, ch. 373, title XVII, § 1704, as added
Pub. L. 94–317, title I, § 102, June 23, 1976, 90 Stat.
698; amended Pub. L. 98–551, § 2(b), Oct. 30, 1984,
98 Stat. 2816.)
AMENDMENTS
1984—Par. (6). Pub. L. 98–551 struck out par. (6) which
provided grant authority to the Secretary to assess,
with respect to the effectiveness, safety, cost, and required training for and conditions of use, of new aspects of health care, and new activities, programs, and
services designed to improve human health and publish
in readily understandable language for public and professional use such assessments and, in the case of controversial aspects of health care, activities, programs,
or services, publish differing views or opinions respecting the effectiveness, safety, cost, and required training
for and conditions of use, of such aspects of health care,
activities, programs, or services.

§ 300u–4. Status reports to President and Congress; study of health education and preventive health services with respect to insurance coverage
(a) The Secretary shall, not later than two
years after June 23, 1976, and biannually thereafter, submit to the President for transmittal to
Congress a report on the status of health information and health promotion, preventive health
services, and education in the appropriate use of
health care. Each such report shall include—
(1) a statement of the activities carried out
under this subchapter since the last report and
the extent to which each such activity
achieves the purposes of this subchapter;
(2) an assessment of the manpower resources
needed to carry out programs relating to

§ 300u–5

health information and health promotion, preventive health services, and education in the
appropriate use of health care, and a statement describing the activities currently being
carried out under this subchapter designed to
prepare teachers and other manpower for such
programs;
(3) the goals and strategy formulated pursuant to section 300u(a)(1) of this title, the models and standards developed under this subchapter, and the results of the study required
by subsection (b) of this section; and
(4) such recommendations as the Secretary
considers appropriate for legislation respecting health information and health promotion,
preventive health services, and education in
the appropriate use of health care, including
recommendations for revisions to and extension of this subchapter.
(b) The Secretary shall conduct a study of
health education services and preventive health
services to determine the coverage of such services under public and private health insurance
programs, including the extent and nature of
such coverage and the cost sharing requirements
required by such programs for coverage of such
services.
(July 1, 1944, ch. 373, title XVII, § 1705, as added
Pub. L. 94–317, title I, § 102, June 23, 1976, 90 Stat.
699; amended Pub. L. 104–66, title I, § 1062(d), Dec.
21, 1995, 109 Stat. 720.)
AMENDMENTS
1995—Subsec. (a). Pub. L. 104–66 substituted ‘‘biannually’’ for ‘‘annually’’ in introductory provisions.
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
of law requiring submittal to Congress of any annual,
semiannual, or other regular periodic report listed in
House Document No. 103–7 (in which item 4 on page 96
identifies a reporting provision which, as subsequently
amended, is contained in subsec. (a) of this section), see
section 3003 of Pub. L. 104–66, as amended, set out as a
note under section 1113 of Title 31, Money and Finance.

§ 300u–5. Centers for research and demonstration
of health promotion and disease prevention
(a) Establishment; grants; contracts; research
and demonstration projects
The Secretary shall make grants or enter into
contracts with academic health centers for the
establishment, maintenance, and operation of
centers for research and demonstration with respect to health promotion and disease prevention. Centers established, maintained, or operated under this section shall undertake research
and demonstration projects in health promotion, disease prevention, and improved methods of appraising health hazards and risk factors, and shall serve as demonstration sites for
the use of new and innovative research in public
health techniques to prevent chronic diseases.
(b) Location; types of research and projects
Each center established, maintained, or operated under this section shall—
(1) be located in an academic health center
with—
(A) a multidisciplinary faculty with expertise in public health and which has working

§ 300u–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

relationships with relevant groups in such
fields as medicine, psychology, nursing, social work, education and business;
(B) graduate training programs relevant to
disease prevention;
(C) a core faculty in epidemiology, biostatistics, social sciences, behavioral and environmental health sciences, and health administration;
(D) a demonstrated curriculum in disease
prevention;
(E) a capability for residency training in
public health or preventive medicine; and
(F) such other qualifications as the Secretary may prescribe;
(2) conduct—
(A) health promotion and disease prevention research, including retrospective studies and longitudinal prospective studies in
population groups and communities;
(B) demonstration projects for the delivery
of services relating to health promotion and
disease prevention to defined population
groups using, as appropriate, community
outreach and organization techniques and
other methods of educating and motivating
communities; and
(C) evaluation studies on the efficacy of
demonstration projects conducted under
subparagraph (B) of this paragraph.
The design of any evaluation study conducted
under subparagraph (C) shall be established
prior to the commencement of the demonstration project under subparagraph (B) for which
the evaluation will be conducted.
(c) Equitable geographic distribution of centers;
procedures
(1) In making grants and entering into contracts under this section, the Secretary shall
provide for an equitable geographical distribution of centers established, maintained, and operated under this section and for the distribution of such centers among areas containing a
wide range of population groups which exhibit
incidences of diseases which are most amenable
to preventive intervention.
(2) The Secretary, through the Director of the
Centers for Disease Control and Prevention and
in consultation with the Director of the National Institutes of Health, shall establish procedures for the appropriate peer review of applications for grants and contracts under this section by peer review groups composed principally
of non-Federal experts.
(d) ‘‘Academic health center’’ defined
For purposes of this section, the term ‘‘academic health center’’ means a school of medicine, a school of osteopathy, or a school of public health, as such terms are defined in section
292a(4) 1 of this title.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated
$10,000,000 for fiscal year 1992, and such sums as
may be necessary for each of the fiscal years
1993 through 2003.
1 See

References in Text note below.

Page 1074

(July 1, 1944, ch. 373, title XVII, § 1706, as added
Pub. L. 98–551, § 2(d), Oct. 30, 1984, 98 Stat. 2816;
amended Pub. L. 100–607, title III, § 312(a)(2), Nov.
4, 1988, 102 Stat. 3113; Pub. L. 102–168, title I,
§ 102, Nov. 26, 1991, 105 Stat. 1102; Pub. L. 102–531,
title III, § 312(d)(12), Oct. 27, 1992, 106 Stat. 3505;
Pub. L. 103–183, title VII, § 705(d), Dec. 14, 1993,
107 Stat. 2241; Pub. L. 105–340, title II, § 204, Oct.
31, 1998, 112 Stat. 3195.)
REFERENCES IN TEXT
Section 292a of this title, referred to in subsec. (d),
was in the original a reference to section 701 of act July
1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702,
relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see section 295p of this title.
PRIOR PROVISIONS
A prior section 300u–5, act July 1, 1944, ch. 373, title
XVII, § 1706, as added June 23, 1976, Pub. L. 94–317, title
I, § 102, 90 Stat. 700; amended Nov. 10, 1978, Pub. L.
95–626, title V, § 501, 92 Stat. 3592; Jan. 4, 1983, Pub. L.
97–414, § 8(r), 96 Stat. 2062, related to establishment of
the Office of Health Promotion, prior to repeal by Pub.
L. 98–551, § 2(c), Oct. 30, 1984, 98 Stat. 2816.
AMENDMENTS
1998—Subsec. (e). Pub. L. 105–340 substituted ‘‘2003’’
for ‘‘1998’’.
1993—Subsec. (e). Pub. L. 103–183 substituted ‘‘through
1998’’ for ‘‘through 1996’’.
1992—Subsec. (c)(2). Pub. L. 102–531, which directed
amendment of subsec. (c)(2)(B) by substituting ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’, was executed by making the substitution in subsec. (c)(2) to reflect the probable intent
of Congress and the redesignation of subsec. (c)(2)(B) as
subsec. (c)(2) by Pub. L. 102–168. See 1991 Amendment
note below.
1991—Subsec. (c). Pub. L. 102–168, § 102(b), redesignated
subpars. (A) and (B) of par. (2) as pars. (1) and (2), respectively, and struck out former par. (1), which read
as follows: ‘‘During fiscal year 1985, the Secretary shall
make grants or enter into contracts for the establishment of three centers under this section. During fiscal
year 1986, the Secretary shall make grants and enter
into contracts for the establishment of five centers
under this section and the maintenance and operation
of the three centers established under this section in
fiscal year 1985. During fiscal year 1987, the Secretary
shall make grants and enter into contracts for the establishment of five centers under this section and the
operation and maintenance of the eight centers established under this section in fiscal years 1985 and 1986.’’
Subsec. (e). Pub. L. 102–168, § 102(a), amended subsec.
(e) generally. Prior to amendment, subsec. (e) read as
follows: ‘‘To carry out this section, there are authorized to be appropriated $3,000,000 for the fiscal year ending September 30, 1985, $8,000,000 for the fiscal year ending September 30, 1986, $13,000,000 for the fiscal year
ending September 30, 1987, $6,000,000 for fiscal year 1989,
$8,000,000 for fiscal year 1990, and $10,000,000 for fiscal
year 1991.’’
1988—Subsec. (e). Pub. L. 100–607 struck out ‘‘and’’
after ‘‘1986,’’ and inserted ‘‘, $6,000,000 for fiscal year
1989, $8,000,000 for fiscal year 1990, and $10,000,000 for fiscal year 1991’’ before period at end.

§ 300u–6. Office of Minority Health
(a) In general
There is established an Office of Minority
Health. The Office of Minority Health as exist-

Page 1075

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing on March 23, 2010, shall be transferred to the
Office of the Secretary in such manner that
there is established in the Office of the Secretary, the Office of Minority Health, which
shall be headed by the Deputy Assistant Secretary for Minority Health who shall report directly to the Secretary, and shall retain and
strengthen authorities (as in existence on March
23, 2010) for the purpose of improving minority
health and the quality of health care minorities
receive, and eliminating racial and ethnic disparities. In carrying out this subsection, the
Secretary, acting through the Deputy Assistant
Secretary, shall award grants, contracts, enter
into memoranda of understanding, cooperative,
interagency, intra-agency and other agreements
with public and nonprofit private entities, agencies, as well as Departmental and Cabinet agencies and organizations, and with organizations
that are indigenous human resource providers in
communities of color to assure improved health
status of racial and ethnic minorities, and shall
develop measures to evaluate the effectiveness
of activities aimed at reducing health disparities and supporting the local community. Such
measures shall evaluate community outreach
activities, language services, workforce cultural
competence, and other areas as determined by
the Secretary.
(b) Duties
With respect to improving the health of racial
and ethnic minority groups, the Secretary, acting through the Deputy Assistant Secretary for
Minority Health (in this section referred to as
the ‘‘Deputy Assistant Secretary’’), shall carry
out the following:
(1) Establish short-range and long-range
goals and objectives and coordinate all other
activities within the Public Health Service
that relate to disease prevention, health promotion, service delivery, and research concerning such individuals. The heads of each of
the agencies of the Service shall consult with
the Deputy Assistant Secretary to ensure the
coordination of such activities.
(2) Enter into interagency agreements with
other agencies of the Public Health Service.
(3) Support research, demonstrations and
evaluations to test new and innovative models.
(4) Increase knowledge and understanding of
health risk factors.
(5) Develop mechanisms that support better
information dissemination, education, prevention, and service delivery to individuals from
disadvantaged backgrounds, including individuals who are members of racial or ethnic minority groups.
(6) Ensure that the National Center for
Health Statistics collects data on the health
status of each minority group.
(7) With respect to individuals who lack proficiency in speaking the English language,
enter into contracts with public and nonprofit
private providers of primary health services
for the purpose of increasing the access of the
individuals to such services by developing and
carrying out programs to provide bilingual or
interpretive services.
(8) Support a national minority health resource center to carry out the following:

§ 300u–6

(A) Facilitate the exchange of information
regarding matters relating to health information and health promotion, preventive
health services, and education in the appropriate use of health care.
(B) Facilitate access to such information.
(C) Assist in the analysis of issues and
problems relating to such matters.
(D) Provide technical assistance with respect to the exchange of such information
(including facilitating the development of
materials for such technical assistance).
(9) Carry out programs to improve access to
health care services for individuals with limited proficiency in speaking the English language. Activities under the preceding sentence
shall include developing and evaluating model
projects.
(10) Advise in matters related to the development, implementation, and evaluation of
health professions education in decreasing disparities in health care outcomes, including
cultural competency as a method of eliminating health disparities.
(c) Advisory Committee
(1) In general
The Secretary shall establish an advisory
committee to be known as the Advisory Committee on Minority Health (in this subsection
referred to as the ‘‘Committee’’).
(2) Duties
The Committee shall provide advice to the
Deputy Assistant Secretary carrying out this
section, including advice on the development
of goals and specific program activities under
paragraphs (1) through (10) of subsection (b) of
this section for each racial and ethnic minority group.
(3) Chair
The chairperson of the Committee shall be
selected by the Secretary from among the
members of the voting members of the Committee. The term of office of the chairperson
shall be 2 years.
(4) Composition
(A) The Committee shall be composed of 12
voting members appointed in accordance with
subparagraph (B), and nonvoting, ex officio
members designated in subparagraph (C).
(B) The voting members of the Committee
shall be appointed by the Secretary from
among individuals who are not officers or employees of the Federal Government and who
have expertise regarding issues of minority
health. The racial and ethnic minority groups
shall be equally represented among such members.
(C) The nonvoting, ex officio members of the
Committee shall be such officials of the Department of Health and Human Services as the
Secretary determines to be appropriate.
(5) Terms
Each member of the Committee shall serve
for a term of 4 years, except that the Secretary shall initially appoint a portion of the
members to terms of 1 year, 2 years, and 3
years.

§ 300u–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) Vacancies
If a vacancy occurs on the Committee, a new
member shall be appointed by the Secretary
within 90 days from the date that the vacancy
occurs, and serve for the remainder of the
term for which the predecessor of such member was appointed. The vacancy shall not affect the power of the remaining members to
execute the duties of the Committee.
(7) Compensation
Members of the Committee who are officers
or employees of the United States shall serve
without compensation. Members of the Committee who are not officers or employees of
the United States shall receive compensation,
for each day (including travel time) they are
engaged in the performance of the functions of
the Committee. Such compensation may not
be in an amount in excess of the daily equivalent of the annual maximum rate of basic pay
payable under the General Schedule (under
title 5) for positions above GS–15.
(d) Certain requirements regarding duties
(1) Recommendations regarding language
(A) Proficiency in speaking English
The Deputy Assistant Secretary shall consult with the Director of the Office of International and Refugee Health, the Director of
the Office of Civil Rights, and the Directors
of other appropriate departmental entities
regarding recommendations for carrying out
activities under subsection (b)(9) of this section.
(B) Health professions education regarding
health disparities
The Deputy Assistant Secretary shall
carry out the duties under subsection (b)(10)
of this section in collaboration with appropriate personnel of the Department of
Health and Human Services, other Federal
agencies, and other offices, centers, and institutions, as appropriate, that have responsibilities under the Minority Health and
Health Disparities Research and Education
Act of 2000.
(2) Equitable allocation regarding activities
In carrying out subsection (b) of this section, the Secretary shall ensure that services
provided under such subsection are equitably
allocated among all groups served under this
section by the Secretary.
(3) Cultural competency of services
The Secretary shall ensure that information
and services provided pursuant to subsection
(b) of this section are provided in the language, educational, and cultural context that
is most appropriate for the individuals for
whom the information and services are intended.
(e) Grants and contracts regarding duties
(1) In general
In carrying out subsection (b) of this section, the Secretary acting through the Deputy
Assistant Secretary may make awards of
grants, cooperative agreements, and contracts
to public and nonprofit private entities.

Page 1076

(2) Process for making awards
The Deputy Assistant Secretary shall ensure
that awards under paragraph (1) are made, to
the extent practical, only on a competitive
basis, and that a grant is awarded for a proposal only if the proposal has been recommended for such an award through a process of peer review.
(3) Evaluation and dissemination
The Deputy Assistant Secretary, directly or
through contracts with public and private entities, shall provide for evaluations of projects
carried out with awards made under paragraph
(1) during the preceding 2 fiscal years. The report shall be included in the report required
under subsection (f) of this section for the fiscal year involved.
(f) Reports
(1) In general
Not later than February 1 of fiscal year 1999
and of each second year thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing the activities carried out under this
section during the preceding 2 fiscal years and
evaluating the extent to which such activities
have been effective in improving the health of
racial and ethnic minority groups. Each such
report shall include the biennial reports submitted under subsections (e)(3) and (f)(2) 1 of
this section for such years by the heads of the
Public Health Service agencies.
(2) Agency reports
Not later than February 1, 1999, and biennially thereafter, the heads of the Public Health
Service agencies shall submit to the Deputy
Assistant Secretary a report summarizing the
minority health activities of each of the respective agencies.
(g) Definitions
For purposes of this section:
(1) The term ‘‘racial and ethnic minority
group’’ means American Indians (including
Alaska Natives, Eskimos, and Aleuts); Asian
Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
(2) The term ‘‘Hispanic’’ means individuals
whose origin is Mexican, Puerto Rican, Cuban,
Central or South American, or any other
Spanish-speaking country.
(h) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2011 through 2016.
(July 1, 1944, ch. 373, title XVII, § 1707, as added
Pub. L. 101–527, § 2, Nov. 6, 1990, 104 Stat. 2312;
amended Pub. L. 101–557, title IV, § 401(a)(1), Nov.
15, 1990, 104 Stat. 2770; Pub. L. 105–392, title II,
§ 201(a), (c), Nov. 13, 1998, 112 Stat. 3582, 3585; Pub.
L. 106–525, title IV, § 403, title VI, § 601, Nov. 22,
2000, 114 Stat. 2509, 2511; Pub. L. 111–148, title X,
§ 10334(a)(1), Mar. 23, 2010, 124 Stat. 971.)
1 See

References in Text note below.

Page 1077

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

The General Schedule, referred to in subsec. (c)(7), is
set out under section 5332 of Title 5, Government Organization and Employees.
The Minority Health and Health Disparities Research
and Education Act of 2000, referred to in subsec.
(d)(1)(B), is Pub. L. 106–525, Nov. 22, 2000, 114 Stat. 2495.
For complete classification of this Act to the Code, see
Short Title of 2000 Amendments note set out under section 201 of this title and Tables.
Subsections (e)(3) and (f)(2) of this section, referred to
in subsec. (f)(1), was in the original ‘‘sections 201(e)(3)
and 201(f)(2)’’, and was translated to reflect the probable intent of Congress, because section 201 of act July
1, 1944, which is classified to section 202 of this title,
does not contain subsections, and subsections (e)(3) and
(f)(2) of this section require biennial reporting.
PRIOR PROVISIONS
A prior section 300u–6, act July 1, 1944, ch. 373, title
XVII, § 1707, as added Nov. 10, 1978, Pub. L. 95–626, title
V, § 502, 92 Stat. 3593; amended July 10, 1979, Pub. L.
96–32, § 6(k), 93 Stat. 84, related to project grants to
State Councils on Physical Fitness for physical fitness
improvement, prior to repeal by Pub. L. 98–551, § 2(c),
Oct. 30, 1984, 98 Stat. 2816.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 10334(a)(1)(A),
amended text of subsec. (a) generally. Prior to amendment, text read as follows: ‘‘There is established an Office of Minority Health within the Office of Public
Health and Science. There shall be in the Department
of Health and Human Services a Deputy Assistant Secretary for Minority Health, who shall be the head of
the Office of Minority Health. The Secretary, acting
through such Deputy Assistant Secretary, shall carry
out this section.’’
Subsec. (h). Pub. L. 111–148, § 10334(a)(1)(B), added subsec. (h) and struck out former subsec. (h). Prior to
amendment, text of subsec. (h), which consisted only of
a par. (1), read as follows:
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
to be appropriated $30,000,000 for fiscal year 1998, and
such sums as may be necessary for each of the fiscal
years 1999 through 2002.’’
2000—Subsec. (b)(10). Pub. L. 106–525, § 403(1), added
par. (10).
Subsec. (c)(2). Pub. L. 106–525, § 403(2), substituted
‘‘paragraphs (1) through (10)’’ for ‘‘paragraphs (1)
through (9)’’.
Subsec. (d)(1). Pub. L. 106–525, § 403(3), amended heading and text of par. (1) generally. Prior to amendment,
text read as follows: ‘‘The Deputy Assistant Secretary
for Minority Health shall consult with the Director of
the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of
other appropriate departmental entities regarding recommendations for carrying out activities under subsection (b)(9) of this section.’’
Subsec. (g)(1). Pub. L. 106–525, § 601, substituted
‘‘Asian Americans;’’ for ‘‘Asian Americans and’’ and inserted ‘‘Native Hawaiians and other’’ before ‘‘Pacific Islanders;’’.
1998—Pub. L. 105–392, § 201(c)(1), struck out ‘‘Establishment of’’ before ‘‘Office’’ in section catchline.
Subsec. (a). Pub. L. 105–392, § 201(c)(2), substituted
‘‘Public Health and Science’’ for ‘‘the Assistant Secretary for Health’’.
Subsecs. (b) to (h). Pub. L. 105–392, § 201(a), added subsecs. (b) to (h) and struck out former subsecs. (b) to (f),
which related, respectively, to duties of Secretary, certain requirements regarding duties, grants and contracts regarding duties, reports, and funding.
1990—Subsec. (b)(8). Pub. L. 101–557 added par. (8).
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,

§ 300u–6

and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 401(a)(2) of Pub. L. 101–557 provided that:
‘‘The amendments made by paragraph (1) [amending
this section] shall take effect on the date of the enactment of the Disadvantaged Minority Health Improvement Act of 1990 [Nov. 6, 1990].’’
TRANSFER OF FUNCTIONS
Pub. L. 111–148, title X, § 10334(a)(2), Mar. 23, 2010, 124
Stat. 971, provided that: ‘‘There are transferred to the
Office of Minority Health in the office of the Secretary
of Health and Human Services, all duties, responsibilities, authorities, accountabilities, functions, staff,
funds, award mechanisms, and other entities under the
authority of the Office of Minority Health of the Public
Health Service as in effect on the date before the date
of enactment of this Act [Mar. 23, 2010], which shall
continue in effect according to the terms in effect on
the date before such date of enactment, until modified,
terminated, superseded, set aside, or revoked in accordance with law by the President, the Secretary, a court
of competent jurisdiction, or by operation of law.’’
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REPORTS
Pub. L. 111–148, title X, § 10334(a)(3), Mar. 23, 2010, 124
Stat. 972, provided that: ‘‘Not later than 1 year after
the date of enactment of this section [Mar. 23, 2010],
and biennially thereafter, the Secretary of Health and
Human Services shall prepare and submit to the appropriate committees of Congress a report describing the
activities carried out under section 1707 of the Public
Health Service Act [42 U.S.C. 300u–6] (as amended by
this subsection) during the period for which the report
is being prepared. Not later than 1 year after the date
of enactment of this section, and biennially thereafter,
the heads of each of the agencies of the Department of
Health and Human Services shall submit to the Deputy
Assistant Secretary for Minority Health a report summarizing the minority health activities of each of the
respective agencies.’’
CONGRESSIONAL FINDINGS
Section 1(b) of Pub. L. 101–527 provided that: ‘‘The
Congress finds that—
‘‘(1) racial and ethnic minorities are disproportionately represented among individuals from disadvantaged backgrounds;

§ 300u–6a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) the health status of individuals from disadvantaged backgrounds, including racial and ethnic minorities, in the United States is significantly lower
than the health status of the general population of
the United States;
‘‘(3) minorities suffer disproportionately high rates
of cancer, stroke, heart diseases, diabetes, substance
abuse, acquired immune deficiency syndrome, and
other diseases and disorders;
‘‘(4) the incidence of infant mortality among minorities is almost double that for the general population;
‘‘(5) Blacks, Hispanics, and Native Americans constitute approximately 12 percent, 7.9 percent, and 0.01
percent, respectively, of the population of the United
States;
‘‘(6) Blacks, Hispanics, and Native Americans in the
United States constitute approximately 3 percent, 4
percent, and less than 0.01 percent, respectively, of
physicians, 2.7 percent, 1.7 percent, and less than 0.01
percent, respectively, of dentists, and 4.5 percent, 1.6
percent, and less than 0.01 percent, respectively, of
nurses;
‘‘(7) the number of individuals who are from disadvantaged backgrounds in health professions should
be increased for the purpose of improving the access
of other such individuals to health services;
‘‘(8) minority health professionals have historically
tended to practice in low-income areas and to serve
minorities;
‘‘(9) minority health professionals have historically
tended to engage in the general practice of medicine
and specialties providing primary care;
‘‘(10) reports published in leading medical journals
indicate that access to health care among minorities
can be substantially improved by increasing the number of minority health professionals;
‘‘(11) increasing the number of minorities serving
on the faculties of health professions schools can be
an important factor in attracting minorities to pursue a career in the health professions;
‘‘(12) diversity in the faculty and student body of
health professions schools enhances the quality of
education for all students attending the schools;
‘‘(13) the Report of the Secretary’s Task Force on
Black and Minority Health (prepared for the Secretary of Health and Human Services and issued in
1985) described the health status problems of minorities, and made recommendations concerning measures that should be implemented by the Secretary
with respect to improving the health status of minorities through programs for providing health information and education; and
‘‘(14) the Office of Minority Health, created in 1985
by the Secretary of Health and Human Services,
should be authorized pursuant to statute and should
receive increased funding to support efforts to improve the health of individuals from disadvantaged
backgrounds, including minorities, including the implementation of the recommendations made by the
Secretary’s Task Force on Black and Minority
Health.’’

§ 300u–6a. Individual offices of minority health
within the Department
(a) In general
The head of each agency specified in subsection (b)(1) 1 shall establish within the agency
an office to be known as the Office of Minority
Health. The head of each such Office shall be appointed by the head of the agency within which
the Office is established, and shall report directly to the head of the agency. The head of
such agency shall carry out this section (as this

section relates to the agency) acting through
such Director.
(b) Specified agencies
The agencies referred to in subsection (a) are
the Centers for Disease Control and Prevention,
the Health Resources and Services Administration, the Substance Abuse and Mental Health
Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug
Administration, and the Centers for Medicare &
Medicaid Services.
(c) Director; appointment
Each Office of Minority Health established in
an agency listed in subsection (a) 2 shall be headed by a director, with documented experience
and expertise in minority health services research and health disparities elimination.
(d) References
Except as otherwise specified, any reference in
Federal law to an Office of Minority Health (in
the Department of Health and Human Services)
is deemed to be a reference to the Office of Minority Health in the Office of the Secretary.
(e) Funding
(1) Allocations
Of the amounts appropriated for a specified
agency for a fiscal year, the Secretary must
designate an appropriate amount of funds for
the purpose of carrying out activities under
this section through the minority health office of the agency. In reserving an amount
under the preceding sentence for a minority
health office for a fiscal year, the Secretary
shall reduce, by substantially the same percentage, the amount that otherwise would be
available for each of the programs of the designated agency involved.
(2) Availability of funds for staffing
The purposes for which amounts made available under paragraph 3 may be expended by a
minority health office include the costs of employing staff for such office.
(July 1, 1944, ch. 373, title XVII, § 1707A, as added
Pub. L. 111–148, title X, § 10334(b)(1), Mar. 23, 2010,
124 Stat. 972.)
CONSTRUCTION
Pub. L. 111–148, title X, § 10334(b)(2), Mar. 23, 2010, 124
Stat. 973, provided that: ‘‘Nothing in this subsection
[enacting this section and provisions set out as a note
under this section] and the amendments made by this
subsection may be construed as establishing regulatory
authority or modifying any existing regulatory authority.’’
LIMITATION ON TERMINATION
Pub. L. 111–148, title X, § 10334(b)(3), Mar. 23, 2010, 124
Stat. 973, provided that: ‘‘Notwithstanding any other
provision of law, a Federal office of minority health or
Federal appointive position with primary responsibility over minority health issues that is in existence in
an office of [or] agency of the Department of Health
and Human Services on the date of enactment of this
section [Mar. 23, 2010] shall not be terminated, reorganized, or have any of its power or duties transferred unless such termination, reorganization, or transfer is approved by an Act of Congress.’’
2 So

1 So

in original. Subsec. (b) does not contain a par. (1).

Page 1078

3 So

in original. Probably should be ‘‘subsection (b)’’.
in original. Probably should be ‘‘paragraph (1)’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300u–7. Office of Adolescent Health
(a) In general
There is established an Office of Adolescent
Health within the Office of the Assistant Secretary for Health, which office 1 shall be headed
by a director 1 appointed by the Secretary. The
Secretary shall carry out this section acting
through the Director of such Office.
(b) Duties
With respect to adolescent health, the Secretary shall—
(1) coordinate all activities within the Department of Health and Human Services that
relate to disease prevention, health promotion, preventive health services, and health
information and education with respect to the
appropriate use of health care, including coordinating—
(A) the design of programs, support for
programs, and the evaluation of programs;
(B) the monitoring of trends;
(C) projects of research (including multidisciplinary projects) on adolescent health;
and
(D) the training of health providers who
work with adolescents, particularly nurse
practitioners, physician assistants, and social workers;
(2) coordinate the activities described in
paragraph (1) with similar activities in the
private sector; and
(3) support projects, conduct research, and
disseminate information relating to preventive medicine, health promotion, and physical
fitness and sports medicine.
(c) Certain demonstration projects
(1) In general
In carrying out subsection (b)(3) of this section, the Secretary may make grants to carry
out demonstration projects for the purpose of
improving adolescent health, including projects to train health care providers in providing services to adolescents and projects to reduce the incidence of violence among adolescents, particularly among minority males.
(2) Authorization of appropriations
For the purpose of carrying out paragraph
(1), there are authorized to be appropriated
$5,000,000 for fiscal year 1993, and such sums as
may be necessary for each of the fiscal years
1994 through 1997.
(d) Information clearinghouse
In carrying out subsection (b) of this section,
the Secretary shall establish and maintain a National Information Clearinghouse on Adolescent
Health to collect and disseminate to health professionals and the general public information on
adolescent health.
(e) National plan
In carrying out subsection (b) of this section,
the Secretary shall develop a national plan for
improving adolescent health. The plan shall be
consistent with the applicable objectives established by the Secretary for the health status of
1 So

in original. Probably should be capitalized.

§ 300u–8

the people of the United States for the year 2000,
and shall be periodically reviewed, and as appropriate, revised. The plan, and any revisions in
the plan, shall be submitted to the Committee
on Energy and Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate.
(f) Adolescent health
For purposes of this section, the term ‘‘adolescent health’’, with respect to adolescents of all
ethnic and racial groups, means all diseases, disorders, and conditions (including with respect to
mental health)—
(1) unique to adolescents, or more serious or
more prevalent in adolescents;
(2) for which the factors of medical risk or
types of medical intervention are different for
adolescents, or for which it is unknown whether such factors or types are different for adolescents; or
(3) with respect to which there has been insufficient clinical research involving adolescents as subjects or insufficient clinical data
on adolescents.
(July 1, 1944, ch. 373, title XVII, § 1708, as added
Pub. L. 102–531, title III, § 302, Oct. 27, 1992, 106
Stat. 3483.)
PRIOR PROVISIONS
A prior section 300u–7, act July 1, 1944, ch. 373, title
XVII, § 1708, as added Nov. 10, 1978, Pub. L. 95–626, title
V, § 502, 92 Stat. 3594; amended July 10, 1979, Pub. L.
96–32, § 6(l), 93 Stat. 84, related to project grants for
physical fitness improvement and research projects,
prior to repeal by Pub. L. 98–551, § 2(c), Oct. 30, 1984, 98
Stat. 2816.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 300u–8. Biennial report regarding nutrition and
health
(a) Biennial report
The Secretary shall require the Surgeon General of the Public Health Service to prepare biennial reports on the relationship between nutrition and health. Such reports may, with respect to such relationship, include any recommendations of the Secretary and the Surgeon
General.
(b) Submission to Congress
The Secretary shall ensure that, not later
than February 1 of 1995 and of every second year
thereafter, a report under subsection (a) of this
section is submitted to the Committee on Energy and Commerce of the House of Representa-

§ 300u–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tives and the Committee on Labor and Human
Resources of the Senate.
(July 1, 1944, ch. 373, title XVII, § 1709, as added
Pub. L. 103–183, title VII, § 704, Dec. 14, 1993, 107
Stat. 2240.)
PRIOR PROVISIONS
A prior section 300u–8, act July 1, 1944, ch. 373, title
XVII, § 1709, as added Nov. 10, 1978, Pub. L. 95–626, title
V, § 502, 92 Stat. 3594, related to establishment of national program on sports medicine research, prior to repeal by Pub. L. 98–551, § 2(c), Oct. 30, 1984, 98 Stat. 2816.

Page 1080

renumbered section 403C by section 104(a)(1) of Pub. L.
109–482 and then section 403D by section 1104(4) of Pub.
L. 110–85. Another section 403C of act July 1, 1944, ch.
373, as added by section 104(a)(3) of Pub. L. 109–482, is
classified to section 283a–2 of this title.
PRIOR PROVISIONS
A prior section 300u–9, act July 1, 1944, ch. 373, title
XVII, § 1710, as added Nov. 10, 1978, Pub. L. 95–626, title
V, § 502, 92 Stat. 3594; amended Oct. 17, 1979, Pub. L.
96–88, title III, § 301(b)(2), title V, § 507, 93 Stat. 678, 692,
related to Conference on Education in Lifetime Sports,
prior to repeal by Pub. L. 98–551, § 2(c), Oct. 30, 1984, 98
Stat. 2816.

CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 300u–9. Education regarding DES
(a) In general
The Secretary, acting through the heads of the
appropriate agencies of the Public Health Service, shall carry out a national program for the
education of health professionals and the public
with respect to the drug diethylstilbestrol (commonly known as DES). To the extent appropriate, such national program shall use methodologies developed through the education demonstration program carried out under section
283a–3 1 of this title. In developing and carrying
out the national program, the Secretary shall
consult closely with representatives of nonprofit
private entities that represent individuals who
have been exposed to DES and that have expertise in community-based information campaigns
for the public and for health care providers. The
implementation of the national program shall
begin during fiscal year 1999.
(b) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 1999 through 2003. The authorization of appropriations established in the preceding sentence is in addition to any other authorization
of appropriation that is available for such purpose.
(July 1, 1944, ch. 373, title XVII, § 1710, as added
Pub. L. 105–340, title I, § 101(b), Oct. 31, 1998, 112
Stat. 3191; amended Pub. L. 109–482, title I,
§ 104(a)(2), Jan. 15, 2007, 120 Stat. 3689.)
REFERENCES IN TEXT
Section 283a–3 of this title, referred to in subsec. (a),
was in the original ‘‘section 403C’’, and was translated
as meaning section 403D of act July 1, 1944, ch. 373, as
1 See

References in Text note below.

AMENDMENTS
2007—Subsec. (a). Pub. L. 109–482 substituted ‘‘section
283a–3’’ for ‘‘section 283a’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

§ 300u–10. National Prevention, Health
motion and Public Health Council

Pro-

(a) Establishment
The President shall establish, within the Department of Health and Human Services, a council to be known as the ‘‘National Prevention,
Health Promotion and Public Health Council’’
(referred to in this section as the ‘‘Council’’).
(b) Chairperson
The President shall appoint the Surgeon General to serve as the chairperson of the Council.
(c) Composition
The Council shall be composed of—
(1) the Secretary of Health and Human Services;
(2) the Secretary of Agriculture;
(3) the Secretary of Education;
(4) the Chairman of the Federal Trade Commission;
(5) the Secretary of Transportation;
(6) the Secretary of Labor;
(7) the Secretary of Homeland Security;
(8) the Administrator of the Environmental
Protection Agency;
(9) the Director of the Office of National
Drug Control Policy;
(10) the Director of the Domestic Policy
Council;
(11) the Assistant Secretary for Indian Affairs;
(12) the Chairman of the Corporation for National and Community Service; and
(13) the head of any other Federal agency
that the chairperson determines is appropriate.
(d) Purposes and duties
The Council shall—
(1) provide coordination and leadership at
the Federal level, and among all Federal departments and agencies, with respect to prevention, wellness and health promotion practices, the public health system, and integrative health care in the United States;
(2) after obtaining input from relevant
stakeholders, develop a national prevention,

Page 1081

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health promotion, public health, and integrative health care strategy that incorporates the
most effective and achievable means of improving the health status of Americans and reducing the incidence of preventable illness and
disability in the United States;
(3) provide recommendations to the President and Congress concerning the most pressing health issues confronting the United
States and changes in Federal policy to
achieve national wellness, health promotion,
and public health goals, including the reduction of tobacco use, sedentary behavior, and
poor nutrition;
(4) consider and propose evidence-based models, policies, and innovative approaches for the
promotion of transformative models of prevention, integrative health, and public health on
individual and community levels across the
United States;
(5) establish processes for continual public
input, including input from State, regional,
and local leadership communities and other
relevant stakeholders, including Indian tribes
and tribal organizations;
(6) submit the reports required under subsection (g); 1 and
(7) carry out other activities determined appropriate by the President.
(e) Meetings
The Council shall meet at the call of the
Chairperson.
(f) Advisory Group
(1) In general
The President shall establish an Advisory
Group to the Council to be known as the ‘‘Advisory Group on Prevention, Health Promotion, and Integrative and Public Health’’
(hereafter referred to in this section as the
‘‘Advisory Group’’). The Advisory Group shall
be within the Department of Health and
Human Services and report to the Surgeon
General.
(2) Composition
(A) In general
The Advisory Group shall be composed of
not more than 25 non-Federal members to be
appointed by the President.
(B) Representation
In appointing members under subparagraph (A), the President shall ensure that
the Advisory Group includes a diverse group
of licensed health professionals, including
integrative health practitioners who have
expertise in—
(i) worksite health promotion;
(ii) community services, including community health centers;
(iii) preventive medicine;
(iv) health coaching;
(v) public health education;
(vi) geriatrics; and
(vii) rehabilitation medicine.
(3) Purposes and duties
The Advisory Group shall develop policy and
program recommendations and advise the
1 So

in original. Probably should be ‘‘(h);’’.

§ 300u–10

Council on lifestyle-based chronic disease prevention and management, integrative health
care practices, and health promotion.
(g) National prevention and health promotion
strategy
Not later than 1 year after March 23, 2010, the
Chairperson, in consultation with the Council,
shall develop and make public a national prevention, health promotion and public health
strategy, and shall review and revise such strategy periodically. Such strategy shall—
(1) set specific goals and objectives for improving the health of the United States
through
federally-supported
prevention,
health promotion, and public health programs,
consistent with ongoing goal setting efforts
conducted by specific agencies;
(2) establish specific and measurable actions
and timelines to carry out the strategy, and
determine accountability for meeting those
timelines, within and across Federal departments and agencies; and
(3) make recommendations to improve Federal efforts relating to prevention, health promotion, public health, and integrative health
care practices to ensure Federal efforts are
consistent with available standards and evidence.
(h) Report
Not later than July 1, 2010, and annually
thereafter through January 1, 2015, the Council
shall submit to the President and the relevant
committees of Congress, a report that—
(1) describes the activities and efforts on
prevention, health promotion, and public
health and activities to develop a national
strategy conducted by the Council during the
period for which the report is prepared;
(2) describes the national progress in meeting specific prevention, health promotion, and
public health goals defined in the strategy and
further describes corrective actions recommended by the Council and taken by relevant agencies and organizations to meet
these goals;
(3) contains a list of national priorities on
health promotion and disease prevention to
address lifestyle behavior modification (smoking cessation, proper nutrition, appropriate
exercise, mental health, behavioral health,
substance use disorder, and domestic violence
screenings) and the prevention measures for
the 5 leading disease killers in the United
States;
(4) contains specific science-based initiatives
to achieve the measurable goals of Healthy
People 2020 regarding nutrition, exercise, and
smoking cessation, and targeting the 5 leading
disease killers in the United States;
(5) contains specific plans for consolidating
Federal health programs and Centers that
exist to promote healthy behavior and reduce
disease risk (including eliminating programs
and offices determined to be ineffective in
meeting the priority goals of Healthy People
2020);
(6) contains specific plans to ensure that all
Federal health care programs are fully coordinated with science-based prevention recommendations by the Director of the Centers for
Disease Control and Prevention; and

§ 300u–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(7) contains specific plans to ensure that all
non-Department of Health and Human Services prevention programs are based on the
science-based guidelines developed by the Centers for Disease Control and Prevention under
paragraph (4).
(i) Periodic reviews
The Secretary and the Comptroller General of
the United States shall jointly conduct periodic
reviews, not less than every 5 years, and evaluations of every Federal disease prevention and
health promotion initiative, program, and agency. Such reviews shall be evaluated based on effectiveness in meeting metrics-based goals with
an analysis posted on such agencies’ public
Internet websites.
(Pub. L. 111–148, title IV, § 4001, title X, § 10401(a),
Mar. 23, 2010, 124 Stat. 538, 974.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (h)(4), (5). Pub. L. 111–148, § 10401(a), substituted ‘‘2020’’ for ‘‘2010’’.
EX. ORD. NO. 13544. ESTABLISHING THE NATIONAL PREVENTION, HEALTH PROMOTION, AND PUBLIC HEALTH
COUNCIL
Ex. Ord. No. 13544, June 10, 2010, 75 F.R. 33983, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, including section 4001 of the Patient Protection and Affordable Care Act (Public Law 111–148), it is
hereby ordered as follows:
SECTION 1. Establishment. There is established within
the Department of Health and Human Services, the National Prevention, Health Promotion, and Public
Health Council (Council).
SEC. 2. Membership.
(a) The Surgeon General shall serve as the Chair of
the Council, which shall be composed of:
(1) the Secretary of Agriculture;
(2) the Secretary of Labor;
(3) the Secretary of Health and Human Services;
(4) the Secretary of Transportation;
(5) the Secretary of Education;
(6) the Secretary of Homeland Security;
(7) the Administrator of the Environmental Protection Agency;
(8) the Chair of the Federal Trade Commission;
(9) the Director of National Drug Control Policy;
(10) the Assistant to the President and Director of the
Domestic Policy Council;
(11) the Assistant Secretary of the Interior for Indian
Affairs;
(12) the Chairman of the Corporation for National and
Community Service; and
(13) the head of any other executive department or
agency that the Chair may, from time to time, determine is appropriate.
(b) The Council shall meet at the call of the Chair.
SEC. 3. Purposes and Duties. The Council shall:
(a) provide coordination and leadership at the Federal level, and among all executive departments and
agencies, with respect to prevention, wellness, and
health promotion practices, the public health system,
and integrative health care in the United States;
(b) develop, after obtaining input from relevant
stakeholders, a national prevention, health promotion,
public health, and integrative health-care strategy that
incorporates the most effective and achievable means
of improving the health status of Americans and reduc-

Page 1082

ing the incidence of preventable illness and disability
in the United States, as further described in section 5
of this order;
(c) provide recommendations to the President and the
Congress concerning the most pressing health issues
confronting the United States and changes in Federal
policy to achieve national wellness, health promotion,
and public health goals, including the reduction of tobacco use, sedentary behavior, and poor nutrition;
(d) consider and propose evidence-based models, policies, and innovative approaches for the promotion of
transformative models of prevention, integrative
health, and public health on individual and community
levels across the United States;
(e) establish processes for continual public input, including input from State, regional, and local leadership
communities and other relevant stakeholders, including Indian tribes and tribal organizations;
(f) submit the reports required by section 6 of this
order; and
(g) carry out such other activities as are determined
appropriate by the President.
SEC. 4. Advisory Group.
(a) There is established within the Department of
Health and Human Services an Advisory Group on Prevention, Health Promotion, and Integrative and Public
Health (Advisory Group), which shall report to the
Chair of the Council.
(b) The Advisory Group shall be composed of not
more than 25 members or representatives from outside
the Federal Government appointed by the President
and shall include a diverse group of licensed health professionals, including integrative health practitioners
who are representative of or have expertise in:
(1) worksite health promotion;
(2) community services, including community health
centers;
(3) preventive medicine;
(4) health coaching;
(5) public health education;
(6) geriatrics; and
(7) rehabilitation medicine.
(c) The Advisory Group shall develop policy and program recommendations and advise the Council on lifestyle-based chronic disease prevention and management, integrative health care practices, and health promotion.
SEC. 5. National Prevention and Health Promotion Strategy. Not later than March 23, 2011, the Chair, in consultation with the Council, shall develop and make
public a national prevention, health promotion, and
public health strategy (national strategy), and shall review and revise it periodically. The national strategy
shall:
(a) set specific goals and objectives for improving the
health of the United States through federally supported
prevention, health promotion, and public health programs, consistent with ongoing goal setting efforts
conducted by specific agencies;
(b) establish specific and measurable actions and
timelines to carry out the strategy, and determine accountability for meeting those timelines, within and
across Federal departments and agencies; and
(c) make recommendations to improve Federal efforts
relating to prevention, health promotion, public
health, and integrative health-care practices to ensure
that Federal efforts are consistent with available
standards and evidence.
SEC. 6. Reports. Not later than July 1, 2010, and annually thereafter until January 1, 2015, the Council shall
submit to the President and the relevant committees of
the Congress, a report that:
(a) describes the activities and efforts on prevention,
health promotion, and public health and activities to
develop the national strategy conducted by the Council
during the period for which the report is prepared;
(b) describes the national progress in meeting specific
prevention, health promotion, and public health goals
defined in the national strategy and further describes
corrective actions recommended by the Council and ac-

Page 1083

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tions taken by relevant agencies and organizations to
meet these goals;
(c) contains a list of national priorities on health promotion and disease prevention to address lifestyle behavior modification (including smoking cessation,
proper nutrition, appropriate exercise, mental health,
behavioral health, substance-use disorder, and domestic violence screenings) and the prevention measures
for the five leading disease killers in the United States;
(d) contains specific science-based initiatives to
achieve the measurable goals of the Healthy People
2020 program of the Department of Health and Human
Services regarding nutrition, exercise, and smoking
cessation, and targeting the five leading disease killers
in the United States;
(e) contains specific plans for consolidating Federal
health programs and centers that exist to promote
healthy behavior and reduce disease risk (including
eliminating programs and offices determined to be ineffective in meeting the priority goals of the Healthy
People 2020 program of the Department of Health and
Human Services);
(f) contains specific plans to ensure that all Federal
health-care programs are fully coordinated with
science-based prevention recommendations by the Director of the Centers for Disease Control and Prevention; and
(g) contains specific plans to ensure that all prevention programs outside the Department of Health and
Human Services are based on the science-based guidelines developed by the Centers for Disease Control and
Prevention under subsection (d) of this section.
SEC. 7. Administration.
(a) The Department of Health and Human Services
shall provide funding and administrative support for
the Council and the Advisory Group to the extent permitted by law and within existing appropriations.
(b) All executive departments and agencies shall provide information and assistance to the Council as the
Chair may request for purposes of carrying out the
Council’s functions, to the extent permitted by law.
(c) Members of the Advisory Group shall serve without compensation, but shall be allowed travel expenses,
including per diem in lieu of subsistence, as authorized
by law for persons serving intermittently in Government service (5 U.S.C. 5701–5707), consistent with the
availability of funds.
SEC. 8. General Provisions.
(a) Insofar as the Federal Advisory Committee Act,
as amended (5 U.S.C App.) may apply to the Advisory
Group, any functions of the President under that Act,
except that of reporting to the Congress, shall be performed by the Secretary of Health and Human Services
in accordance with the guidelines that have been issued
by the Administrator of General Services.
(b) Nothing in this order shall be construed to impair
or otherwise affect:
(1) authority granted by law to an executive department, agency, or the head thereof; or
(2) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
BARACK OBAMA.

§ 300u–11. Prevention and Public Health Fund
(a) Purpose
It is the purpose of this section to establish a
Prevention and Public Health Fund (referred to
in this section as the ‘‘Fund’’), to be administered through the Department of Health and
Human Services, Office of the Secretary, to provide for expanded and sustained national investment in prevention and public health programs

§ 300u–12

to improve health and help restrain the rate of
growth in private and public sector health care
costs.
(b) Funding
There are hereby authorized to be appropriated, and appropriated, to the Fund, out of
any monies in the Treasury not otherwise appropriated—
(1) for fiscal year 2010, $500,000,000;
(2) for fiscal year 2011, $750,000,000;
(3) for fiscal year 2012, $1,000,000,000;
(4) for fiscal year 2013, $1,250,000,000;
(5) for fiscal year 2014, $1,500,000,000; and
(6) for fiscal year 2015, and each fiscal year
thereafter, $2,000,000,000.
(c) Use of Fund
The Secretary shall transfer amounts in the
Fund to accounts within the Department of
Health and Human Services to increase funding,
over the fiscal year 2008 level, for programs authorized by the Public Health Service Act [42
U.S.C. 201 et seq.], for prevention, wellness, and
public health activities including prevention research, health screenings, and initiatives, such
as the Community Transformation grant program, the Education and Outreach Campaign
Regarding Preventive Benefits, and immunization programs.
(d) Transfer authority
The Committee on Appropriations of the Senate and the Committee on Appropriations of the
House of Representatives may provide for the
transfer of funds in the Fund to eligible activities under this section, subject to subsection (c).
(Pub. L. 111–148, title IV, § 4002, title X, § 10401(b),
Mar. 23, 2010, 124 Stat. 541, 974.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec.
(c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to this chapter. For complete classification of this Act to the Code, see Short Title note
set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (c). Pub. L. 111–148, § 10401(b), substituted ‘‘research, health screenings, and initiatives’’
for ‘‘research and health screenings’’ and ‘‘Regarding
Preventive’’ for ‘‘for Preventive’’.

§ 300u–12. Education and outreach campaign regarding preventive benefits
(a) In general
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’)
shall provide for the planning and implementation of a national public–private partnership for
a prevention and health promotion outreach and
education campaign to raise public awareness of
health improvement across the life span. Such
campaign shall include the dissemination of information that—
(1) describes the importance of utilizing preventive services to promote wellness, reduce

§ 300u–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

health disparities, and mitigate chronic disease;
(2) promotes the use of preventive services
recommended by the United States Preventive
Services Task Force and the Community Preventive Services Task Force;
(3) encourages healthy behaviors linked to
the prevention of chronic diseases;
(4) explains the preventive services covered
under health plans offered through an Exchange;
(5) describes additional preventive care supported by the Centers for Disease Control and
Prevention, the Health Resources and Services
Administration, the Substance Abuse and
Mental Health Services Administration, the
Advisory Committee on Immunization Practices, and other appropriate agencies; and
(6) includes general health promotion information.
(b) Consultation
In coordinating the campaign under subsection (a), the Secretary shall consult with the
Institute of Medicine to provide ongoing advice
on evidence-based scientific information for policy, program development, and evaluation.
(c) Media campaign
(1) In general
Not later than 1 year after March 23, 2010,
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall establish and implement a national
science-based media campaign on health promotion and disease prevention.
(2) Requirement of campaign
The campaign implemented under paragraph
(1)—
(A) shall be designed to address proper nutrition, regular exercise, smoking cessation,
obesity reduction, the 5 leading disease killers in the United States, and secondary prevention through disease screening promotion;
(B) shall be carried out through competitively bid contracts awarded to entities providing for the professional production and
design of such campaign;
(C) may include the use of television,
radio, Internet, and other commercial marketing venues and may be targeted to specific age groups based on peer-reviewed social research;
(D) shall not be duplicative of any other
Federal efforts relating to health promotion
and disease prevention; and
(E) may include the use of humor and nationally recognized positive role models.
(3) Evaluation
The Secretary shall ensure that the campaign implemented under paragraph (1) is subject to an independent evaluation every 2
years and shall report every 2 years to Congress on the effectiveness of such campaigns
towards meeting science-based metrics.
(d) Website
The Secretary, in consultation with privatesector experts, shall maintain or enter into a

Page 1084

contract to maintain an Internet website to provide science-based information on guidelines for
nutrition, regular exercise, obesity reduction,
smoking cessation, and specific chronic disease
prevention. Such website shall be designed to
provide information to health care providers and
consumers.
(e) Dissemination of information through providers
The Secretary, acting through the Centers for
Disease Control and Prevention, shall develop
and implement a plan for the dissemination of
health promotion and disease prevention information consistent with national priorities, to
health care providers who participate in Federal
programs, including programs administered by
the Indian Health Service, the Department of
Veterans Affairs, the Department of Defense,
and the Health Resources and Services Administration, and Medicare and Medicaid.
(f) Personalized prevention plans
(1) Contract
The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall enter into a contract with a qualified entity for the development and operation
of a Federal Internet website personalized prevention plan tool.
(2) Use
The website developed under paragraph (1)
shall be designed to be used as a source of the
most up-to-date scientific evidence relating to
disease prevention for use by individuals. Such
website shall contain a component that enables an individual to determine their disease
risk (based on personal health and family history, BMI, and other relevant information) relating to the 5 leading diseases in the United
States, and obtain personalized suggestions
for preventing such diseases.
(g) Internet portal
The Secretary shall establish an Internet portal for accessing risk-assessment tools developed
and maintained by private and academic entities.
(h) Priority funding
Funding for the activities authorized under
this section shall take priority over funding provided through the Centers for Disease Control
and Prevention for grants to States and other
entities for similar purposes and goals as provided for in this section. Not to exceed
$500,000,000 shall be expended on the campaigns
and activities required under this section.
(i) Public awareness of preventive and obesityrelated services
(1) Information to States
The Secretary of Health and Human Services shall provide guidance and relevant information to States and health care providers regarding preventive and obesity-related services that are available to Medicaid enrollees,
including obesity screening and counseling for
children and adults.
(2) Information to enrollees
Each State shall design a public awareness
campaign to educate Medicaid enrollees re-

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garding availability and coverage of such services, with the goal of reducing incidences of
obesity.
(3) Report
Not later than January 1, 2011, and every 3
years thereafter through January 1, 2017, the
Secretary of Health and Human Services shall
report to Congress on the status and effectiveness of efforts under paragraphs (1) and (2), including summaries of the States’ efforts to increase awareness of coverage of obesity-related services.
(j) Authorization of appropriations
There are authorized to be appropriated such
sums as may be necessary to carry out this section.
(Pub. L. 111–148, title IV, § 4004, title X, § 10401(c),
Mar. 23, 2010, 124 Stat. 544, 975.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (a)(4). Pub. L. 111–148, § 10401(c), substituted ‘‘an Exchange’’ for ‘‘a Gateway’’.

§ 300u–13. Community transformation grants
(a) In general
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’),
acting through the Director of the Centers for
Disease Control and Prevention (referred to in
this section as the ‘‘Director’’), shall award
competitive grants to State and local governmental agencies and community-based organizations for the implementation, evaluation, and
dissemination of evidence-based community preventive health activities in order to reduce
chronic disease rates, prevent the development
of secondary conditions, address health disparities, and develop a stronger evidence-base of effective prevention programming, with not less
than 20 percent of such grants being awarded to
rural and frontier areas.
(b) Eligibility
To be eligible to receive a grant under subsection (a), an entity shall—
(1) be—
(A) a State governmental agency;
(B) a local governmental agency;
(C) a national network of communitybased organizations;
(D) a State or local non-profit organization; or
(E) an Indian tribe; and
(2) submit to the Director an application at
such time, in such a manner, and containing
such information as the Director may require,
including a description of the program to be
carried out under the grant; and
(3) demonstrate a history or capacity, if
funded, to develop relationships necessary to
engage key stakeholders from multiple sectors
within and beyond health care and across a
community, such as healthy futures corps and
health care providers.

§ 300u–13

(c) Use of funds
(1) In general
An eligible entity shall use amounts received under a grant under this section to
carry out programs described in this subsection.
(2) Community transformation plan
(A) In general
An eligible entity that receives a grant
under this section shall submit to the Director (for approval) a detailed plan that includes the policy, environmental, programmatic, and 1 as appropriate 1 infrastructure changes needed to promote healthy living and reduce disparities.
(B) Activities
Activities within the plan may focus on
(but not be limited to)—
(i) creating healthier school environments, including increasing healthy food
options, physical activity opportunities,
promotion of healthy lifestyle, emotional
wellness, and prevention curricula, and activities to prevent chronic diseases;
(ii) creating the infrastructure to support active living and access to nutritious
foods in a safe environment;
(iii) developing and promoting programs
targeting a variety of age levels to increase access to nutrition, physical activity and smoking cessation, improve social
and emotional wellness, enhance safety in
a community, or address any other chronic
disease priority area identified by the
grantee;
(iv) assessing and implementing worksite wellness programming and incentives;
(v) working to highlight healthy options
at restaurants and other food venues;
(vi) prioritizing strategies to reduce racial and ethnic disparities, including social, economic, and geographic determinants of health; and
(vii) addressing special populations
needs, including all age groups and individuals with disabilities, and individuals
in urban, rural, and frontier areas.
(3) Community-based prevention health activities
(A) In general
An eligible entity shall use amounts received under a grant under this section to
implement a variety of programs, policies,
and infrastructure improvements to promote
healthier lifestyles.
(B) Activities
An eligible entity shall implement activities detailed in the community transformation plan under paragraph (2).
(C) In-kind support
An eligible entity may provide in-kind resources such as staff, equipment, or office
space in carrying out activities under this
section.
1 So

in original. Probably should be followed by a comma.

§ 300u–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) Evaluation
(A) In general
An eligible entity shall use amounts provided under a grant under this section to
conduct activities to measure changes in the
prevalence of chronic disease risk factors
among community members participating in
preventive health activities 2
(B) Types of measures
In carrying out subparagraph (A), the eligible entity shall, with respect to residents
in the community, measure—
(i) changes in weight;
(ii) changes in proper nutrition;
(iii) changes in physical activity;
(iv) changes in tobacco use prevalence;
(v) changes in emotional well-being and
overall mental health;
(vi) other factors using community-specific data from the Behavioral Risk Factor
Surveillance Survey; and
(vii) other factors as determined by the
Secretary.
(C) Reporting
An eligible entity shall annually submit to
the Director a report containing an evaluation of activities carried out under the
grant.
(5) Dissemination
A grantee under this section shall—
(A) meet at least annually in regional or
national meetings to discuss challenges, best
practices, and lessons learned with respect
to activities carried out under the grant; and
(B) develop models for the replication of
successful programs and activities and the
mentoring of other eligible entities.
(d) Training
(1) In general
The Director shall develop a program to provide training for eligible entities on effective
strategies for the prevention and control of
chronic disease and the link between physical,
emotional, and social well-being.
(2) Community transformation plan
The Director shall provide appropriate feedback and technical assistance to grantees to
establish community transformation plans 2
(3) Evaluation
The Director shall provide a literature review and framework for the evaluation of programs conducted as part of the grant program
under this section, in addition to working with
academic institutions or other entities with
expertise in outcome evaluation.
(e) Prohibition
A grantee shall not use funds provided under a
grant under this section to create video games
or to carry out any other activities that may
lead to higher rates of obesity or inactivity.
(f) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, such sums as may be necessary for each of fiscal year 3 2010 through 2014.
2 So
3 So

in original. Probably should be followed by a period.
in original. Probably should be ‘‘years’’.

Page 1086

(Pub. L. 111–148, title IV, § 4201, title X, § 10403,
Mar. 23, 2010, 124 Stat. 564, 975.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 10403(1), inserted
‘‘, with not less than 20 percent of such grants being
awarded to rural and frontier areas’’ before period at
end.
Subsec. (c)(2)(B)(vii). Pub. L. 111–148, § 10403(2), substituted ‘‘urban, rural, and frontier areas’’ for ‘‘both
urban and rural areas’’.
Subsec. (f). Pub. L. 111–148, § 10403(3), substituted
‘‘each of fiscal year’’ for ‘‘each fiscal years’’.

§ 300u–14. Healthy aging, living well; evaluation
of community-based prevention and wellness
programs for Medicare beneficiaries
(a) Healthy aging, living well
(1) In general
The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Director of the
Centers for Disease Control and Prevention,
shall award grants to State or local health departments and Indian tribes to carry out 5year pilot programs to provide public health
community interventions, screenings, and
where necessary, clinical referrals for individuals who are between 55 and 64 years of age.
(2) Eligibility
To be eligible to receive a grant under paragraph (1), an entity shall—
(A) be—
(i) a State health department;
(ii) a local health department; or
(iii) an Indian tribe;
(B) submit to the Secretary an application
at such time, in such manner, and containing such information as the Secretary may
require including a description of the program to be carried out under the grant;
(C) design a strategy for improving the
health of the 55-to-64 year-old population
through community-based public health
interventions; and
(D) demonstrate the capacity, if funded, to
develop the relationships necessary with relevant health agencies, health care providers,
community-based organizations, and insurers to carry out the activities described in
paragraph (3), such relationships to include
the identification of a community-based
clinical partner, such as a community
health center or rural health clinic.
(3) Use of funds
(A) In general
A State or local health department shall
use amounts received under a grant under
this subsection to carry out a program to
provide the services described in this paragraph to individuals who are between 55 and
64 years of age.
(B) Public health interventions
(i) In general
In developing and implementing such activities, a grantee shall collaborate with

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the Centers for Disease Control and Prevention and the Administration on Aging,
and relevant local agencies and organizations.
(ii) Types of intervention activities
Intervention activities conducted under
this subparagraph may include efforts to
improve nutrition, increase physical activity, reduce tobacco use and substance
abuse, improve mental health, and promote healthy lifestyles among the target
population.
(C) Community preventive screenings
(i) In general
In addition to community-wide public
health interventions, a State or local
health department shall use amounts received under a grant under this subsection
to conduct ongoing health screening to
identify risk factors for cardiovascular disease, cancer, stroke, and diabetes among
individuals in both urban and rural areas
who are between 55 and 64 years of age.
(ii) Types of screening activities
Screening activities conducted under
this subparagraph may include—
(I) mental health/behavioral health
and substance use disorders;
(II) physical activity, smoking, and nutrition; and
(III) any other measures deemed appropriate by the Secretary.
(iii) Monitoring
Grantees under this section shall maintain records of screening results under this
subparagraph to establish the baseline
data for monitoring the targeted population 1
(D) Clinical referral/treatment for chronic
diseases
(i) In general
A State or local health department shall
use amounts received under a grant under
this subsection to ensure that individuals
between 55 and 64 years of age who are
found to have chronic disease risk factors
through the screening activities described
in subparagraph (C)(ii), receive clinical referral/treatment for follow-up services to
reduce such risk.
(ii) Mechanism
(I) Identification and determination of
status
With respect to each individual with
risk factors for or having heart disease,
stroke, diabetes, or any other condition
for which such individual was screened
under subparagraph (C), a grantee under
this section shall determine whether or
not such individual is covered under any
public or private health insurance program.
(II) Insured individuals
An individual determined to be covered
under a health insurance program under
1 So

in original. Probably should be followed by a period.

§ 300u–14

subclause (I) shall be referred by the
grantee to the existing providers under
such program or, if such individual does
not have a current provider, to a provider who is in-network with respect to
the program involved.
(III) Uninsured individuals
With respect to an individual determined to be uninsured under subclause
(I), the grantee’s community-based clinical partner described in paragraph
(4)(D) 2 shall assist the individual in determining eligibility for available public
coverage options and identify other appropriate community health care resources and assistance programs.
(iii) Public health intervention program
A State or local health department shall
use amounts received under a grant under
this subsection to enter into contracts
with community health centers or rural
health clinics and mental health and substance use disorder service providers to assist in the referral/treatment of at risk patients to community resources for clinical
follow-up and help determine eligibility
for other public programs.
(E) Grantee evaluation
An eligible entity shall use amounts provided under a grant under this subsection to
conduct activities to measure changes in the
prevalence of chronic disease risk factors
among participants.
(4) Pilot program evaluation
The Secretary shall conduct an annual evaluation of the effectiveness of the pilot program under this subsection. In determining
such effectiveness, the Secretary shall consider changes in the prevalence of uncontrolled chronic disease risk factors among new
Medicare enrollees (or individuals nearing enrollment, including those who are 63 and 64
years of age) who reside in States or localities
receiving grants under this section as compared with national and historical data for
those States and localities for the same population.
(5) Authorization of appropriations
There are authorized to be appropriated to
carry out this subsection, such sums as may
be necessary for each of fiscal years 2010
through 2014.
(b) Evaluation and plan for community-based
prevention and wellness programs for Medicare beneficiaries
(1) In general
The Secretary shall conduct an evaluation
of community-based prevention and wellness
programs and develop a plan for promoting
healthy lifestyles and chronic disease selfmanagement for Medicare beneficiaries.
(2) Medicare evaluation of prevention and
wellness programs
(A) In general
The Secretary shall evaluate community
prevention and wellness programs including
2 So

in original. Paragraph (4) does not contain subpars.

§ 300u–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

those that are sponsored by the Administration on Aging, are evidence-based, and have
demonstrated potential to help Medicare
beneficiaries (particularly beneficiaries that
have attained 65 years of age) reduce their
risk of disease, disability, and injury by
making healthy lifestyle choices, including
exercise, diet, and self-management of
chronic diseases.
(B) Evaluation
The evaluation under subparagraph (A)
shall consist of the following:
(i) Evidence review
The Secretary shall review available evidence, literature, best practices, and resources that are relevant to programs that
promote healthy lifestyles and reduce risk
factors for the Medicare population. The
Secretary may determine the scope of the
evidence review and such issues to be considered, which shall include, at a minimum—
(I) physical activity, nutrition, and
obesity;
(II) falls;
(III) chronic disease self-management;
and
(IV) mental health.
(ii) Independent evaluation of evidencebased community prevention and
wellness programs
The Administrator of the Centers for
Medicare & Medicaid Services, in consultation with the Assistant Secretary for
Aging, shall, to the extent feasible and
practicable, conduct an evaluation of existing community prevention and wellness
programs that are sponsored by the Administration on Aging to assess the extent
to which Medicare beneficiaries who participate in such programs—
(I) reduce their health risks, improve
their health outcomes, and adopt and
maintain healthy behaviors;
(II) improve their ability to manage
their chronic conditions; and
(III) reduce their utilization of health
services and associated costs under the
Medicare program for conditions that
are amenable to improvement under
such programs.
(3) Report
Not later than September 30, 2013, the Secretary shall submit to Congress a report that
includes—
(A) recommendations for such legislation
and administrative action as the Secretary
determines appropriate to promote healthy
lifestyles and chronic disease self-management for Medicare beneficiaries;
(B) any relevant findings relating to the
evidence review under paragraph (2)(B)(i);
and
(C) the results of the evaluation under
paragraph (2)(B)(ii).
(4) Funding
For purposes of carrying out this subsection,
the Secretary shall provide for the transfer,

Page 1088

from the Federal Hospital Insurance Trust
Fund under section 1817 of the Social Security
Act (42 U.S.C. 1395i) and the Federal Supplemental 3 Medical Insurance Trust Fund under
section 1841 of such Act (42 U.S.C. 1395t), in
such proportion as the Secretary determines
appropriate, of $50,000,000 to the Centers for
Medicare & Medicaid Services Program Management Account. Amounts transferred under
the preceding sentence shall remain available
until expended.
(5) Administration
Chapter 35 of title 44 shall not apply to the
this subsection.
(6) Medicare beneficiary
In this subsection, the term ‘‘Medicare beneficiary’’ means an individual who is entitled to
benefits under part A of title XVIII of the Social Security Act [42 U.S.C. 1395c et seq.] and
enrolled under part B of such title [42 U.S.C.
1395j et seq.].
(Pub. L. 111–148, title IV, § 4202, Mar. 23, 2010, 124
Stat. 566.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(6),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Parts A and B
of title XVIII of the Act are classified generally to
parts A (§ 1395c et seq.) and B (§ 1395j et seq.), respectively, of subchapter XVIII of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

§ 300u–15. Research on optimizing the delivery of
public health services
(a) In general
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’),
acting through the Director of the Centers for
Disease Control and Prevention, shall provide
funding for research in the area of public health
services and systems.
(b) Requirements of research
Research supported under this section shall
include—
(1) examining evidence-based practices relating to prevention, with a particular focus on
high priority areas as identified by the Secretary in the National Prevention Strategy or
Healthy People 2020, and including comparing
community-based public health interventions
in terms of effectiveness and cost;
(2) analyzing the translation of interventions from academic settings to real world settings; and
(3) identifying effective strategies for organizing, financing, or delivering public health
services in real world community settings, including comparing State and local health department structures and systems in terms of
effectiveness and cost.
(c) Existing partnerships
Research supported under this section shall be
coordinated with the Community Preventive
3 So

in original. Probably should be ‘‘Supplementary’’.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Services Task Force and carried out by building
on existing partnerships within the Federal Government while also considering initiatives at
the State and local levels and in the private sector.
(d) Annual report
The Secretary shall, on an annual basis, submit to Congress a report concerning the activities and findings with respect to research supported under this section.
(Pub. L. 111–148, title IV, § 4301, Mar. 23, 2010, 124
Stat. 578.)
CODIFICATION
Section was enacted as part of the Patient Protection
and Affordable Care Act, and not as part of the Public
Health Service Act which comprises this chapter.

SUBCHAPTER XVI—PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL
AND BEHAVIOR RESEARCH
§ 300v. Commission
(a) Establishment; composition; appointment of
members; vacancies
(1) There is established the President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research (hereinafter in this subchapter referred
to as the ‘‘Commission’’) which shall be composed of eleven members appointed by the President. The members of the Commission shall be
appointed as follows:
(A) Three of the members shall be appointed
from individuals who are distinguished in biomedical or behavioral research.
(B) Three of the members shall be appointed
from individuals who are distinguished in the
practice of medicine or otherwise distinguished in the provision of health care.
(C) Five of the members shall be appointed
from individuals who are distinguished in one
or more of the fields of ethics, theology, law,
the natural sciences (other than a biomedical
or behavioral science), the social sciences, the
humanities, health administration, government, and public affairs.
(2) No individual who is a full–time officer or
employee of the United States may be appointed
as a member of the Commission. The Secretary
of Health and Human Services, the Secretary of
Defense, the Director of Central Intelligence,
the Director of the Office of Science and Technology Policy, the Secretary of Veterans Affairs, and the Director of the National Science
Foundation shall each designate an individual
to provide liaison with the Commission.
(3) No individual may be appointed to serve as
a member of the Commission if the individual
has served for two terms of four years each as
such a member.
(4) A vacancy in the Commission shall be filled
in the manner in which the original appointment was made.
(b) Terms of members
(1) Except as provided in paragraphs (2) and
(3), members shall be appointed for terms of four
years.

§ 300v

(2) Of the members first appointed—
(A) four shall be appointed for terms of three
years, and
(B) three shall be appointed for terms of two
years,
as designated by the President at the time of appointment.
(3) Any member appointed to fill a vacancy occurring before the expiration of the term for
which his predecessor was appointed shall be appointed only for the remainder of such term. A
member may serve after the expiration of his
term until his successor has taken office.
(c) Chairman
The Chairman of the Commission shall be appointed by the President, by and with the advice
and consent of the Senate, from members of the
Commission.
(d) Meetings
(1) Seven members of the Commission shall
constitute a quorum for business, but a lesser
number may conduct hearings.
(2) The Commission shall meet at the call of
the Chairman or at the call of a majority of its
members.
(e) Compensation; travel expenses, etc.
(1) Members of the Commission shall each be
entitled to receive the daily equivalent of the
annual rate of basic pay in effect for grade
GS–18 of the General Schedule for each day (including travel time) during which they are engaged in the actual performance of duties vested
in the Commission.
(2) While away from their homes or regular
places of business in the performance of services
for the Commission, members of the Commission shall be allowed travel expenses, including
per diem in lieu of subsistence, in the same manner as persons employed intermittently in the
Government service are allowed expenses under
section 5703 of title 5.
(July 1, 1944, ch. 373, title XVIII, § 1801, as added
Pub. L. 95–622, title III, § 301, Nov. 9, 1978, 92 Stat.
3437; amended Pub. L. 96–88, title V, § 509(b), Oct.
17, 1979, 93 Stat. 695; Pub. L. 100–527, § 10(1), Oct.
25, 1988, 102 Stat. 2640.)
AMENDMENTS
1988—Subsec. (a)(2). Pub. L. 100–527 substituted ‘‘Secretary of Veterans Affairs’’ for ‘‘Administrator of Veterans’ Affairs’’.
CHANGE OF NAME
Reference to the Director of Central Intelligence or
the Director of the Central Intelligence Agency in the
Director’s capacity as the head of the intelligence community deemed to be a reference to the Director of National Intelligence. Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director’s capacity as the head of
the Central Intelligence Agency deemed to be a reference to the Director of the Central Intelligence Agency. See section 1081(a), (b) of Pub. L. 108–458, set out as
a note under section 401 of Title 50, War and National
Defense.
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a)(2) pursuant to section 509(b) of Pub.
L. 96–88, which is classified to section 3508(b) of Title 20,
Education.

§ 300v–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100–527 effective Mar. 15, 1989,
see section 18(a) of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 301 of
Title 38, Veterans’ Benefits.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
APPOINTMENT OF INITIAL MEMBERS
Section 302(a) of Pub. L. 95–622 directed President to
initially appoint members to President’s Commission
for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (established under
the amendment made by section 301) [enacting this subchapter] not later than 90 days after Nov. 9, 1978.
EXECUTIVE ORDER NO. 12184
Ex. Ord. No. 12184, Dec. 17, 1979, 44 F.R. 75091, which
established the President’s Special Commission for the
Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research, was revoked by Ex. Ord. No.
12553, Feb. 25, 1986, 51 F.R. 7237.

§ 300v–1. Duties of Commission
(a) Studies and investigations; priority and
order; report to President and Congress
(1) The Commission shall undertake studies of
the ethical and legal implications of—
(A) the requirements for informed consent to
participation in research projects and to
otherwise undergo medical procedures;
(B) the matter of defining death, including
the advisability of developing a uniform definition of death;
(C) voluntary testing, counseling, and information and education programs with respect
to genetic diseases and conditions, taking into
account the essential equality of all human
beings, born and unborn;
(D) the differences in the availability of
health services as determined by the income
or residence of the persons receiving the services;
(E) current procedures and mechanisms designed (i) to safeguard the privacy of human
subjects of behavioral and biomedical research, (ii) to ensure the confidentiality of individually identifiable patient records, and
(iii) to ensure appropriate access of patients to
information continued 1 in such records,2 and
(F) such other matters relating to medicine
or biomedical or behavioral research as the
President may designate for study by the
Commission.
The Commission shall determine the priority
and order of the studies required under this
paragraph.
(2) The Commission may undertake an investigation or study of any other appropriate matter which relates to medicine or biomedical or
behavioral research (including the protection of
1 So
2 So

in original. Probably should be ‘‘contained’’.
in original. The comma probably should be a semicolon.

Page 1090

human subjects of biomedical or behavioral research) and which is consistent with the purposes of this subchapter on its own initiative or
at the request of the head of a Federal agency.
(3) In order to avoid duplication of effort, the
Commission may, in lieu of, or as part of, any
study or investigation required or otherwise
conducted under this subsection, use a study or
investigation conducted by another entity if the
Commission sets forth its reasons for such use.
(4) Upon the completion of each investigation
or study undertaken by the Commission under
this subsection (including a study or investigation which merely uses another study or investigation), it shall report its findings (including
any recommendations for legislation or administrative action) to the President and the Congress and to each Federal agency to which a recommendation in the report applies.
(b) Recommendations to agencies; subsequent
administrative requirements
(1) Within 60 days of the date a Federal agency
receives a recommendation from the Commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall provide opportunity for interested persons to submit written data, views, and arguments with respect to adoption of the recommendation.
(2) Within the 180-day period beginning on the
date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate, and, to the extent
that it determines that—
(A) such action is not appropriate, the agency shall, within such time period, provide the
Commission with, and publish in the Federal
Register, a notice of such determination (including an adequate statement of the reasons
for the determination), or
(B) such action is appropriate, the agency
shall undertake such action as expeditiously
as feasible and shall notify the Commission of
the determination and the action undertaken.
(c) Report on protection of human subjects;
scope; submission to President, etc.
The Commission shall biennially report to the
President, the Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral research.
Each such report shall include a review of the
adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal
agencies regarding the protection of human subjects of biomedical or behavioral research which
such agencies conduct or support, and (2) of the
implementation of such rules, policies, guidelines, and regulations by such agencies, and may
include such recommendations for legislation
and administrative action as the Commission
deems appropriate.
(d) Annual report; scope; submission to President, etc.
Not later than December 15 of each year (beginning with 1979) the Commission shall report
to the President, the Congress, and appropriate
Federal agencies on the activities of the Commission during the fiscal year ending in such

Page 1091

TITLE 42—THE PUBLIC HEALTH AND WELFARE

year. Each such report shall include a complete
list of all recommendations described in subsection (b)(1) of this section made to Federal
agencies by the Commission during the fiscal
year and the actions taken, pursant 3 to subsection (b)(2) of this section, by the agencies
upon such recommendations, and may include
such recommendations for legislation and administrative action as the Commission deems
appropriate.
(e) Publication and dissemination of reports
The Commission may at any time publish and
disseminate to the public reports respecting its
activities.
(f) Definitions
For purposes of this section:
(1) The term ‘‘Federal agency’’ means an authority of the government of the United
States, but does not include (A) the Congress,
(B) the courts of the United States, and (C) the
government of the Commonwealth of Puerto
Rico, the government of the District of Columbia, or the government of any territory or possession of the United States.
(2) The term ‘‘protection of human subjects’’
includes the protection of the health, safety,
and privacy of individuals.
(July 1, 1944, ch. 373, title XVIII, § 1802, as added
Pub. L. 95–622, title III, § 301, Nov. 9, 1978, 92 Stat.
3439; amended Pub. L. 96–32, § 4, July 10, 1979, 93
Stat. 82.)
AMENDMENTS
1979—Subsec. (f). Pub. L. 96–32 redesignated definitions subsection following subsec. (e) as (f), which in
original was designated as ‘‘(b)’’.

§ 300v–2. Administrative provisions
(a) Hearings
The Commission may for the purpose of carrying out this subchapter hold such hearings, sit
and act at such times and places, take such testimony, and receive such evidence, as the Commission may deem advisable.
(b) Appointment and compensation of staff personnel; procurement and compensation of
temporary and intermittent services; detail
of personnel from other Federal agencies
(1) The Commission may appoint and fix the
pay of such staff personnel as it deems desirable.
Such personnel shall be appointed subject to the
provisions of title 5 governing appointments in
the competitive service, and shall be paid in accordance with the provisions of chapter 51 and
subchapter III of chapter 53 of such title relating
to classification and General Schedule pay
rates.
(2) The Commission may procure temporary
and intermittent services to the same extent as
is authorized by section 3109(b) of title 5, but at
rates for individuals not to exceed the daily
equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule.
(3) Upon request of the Commission, the head
of any Federal agency is authorized to detail, on
a reimbursable basis, any of the personnel of
3 So

in original. Probably should be ‘‘pursuant’’.

§ 300v–3

such agency to the Commission to assist it in
carrying out its duties under this subchapter.
(c) Contracting authority
The Commission, in performing its duties and
functions under this subchapter, may enter into
contracts with appropriate public or nonprofit
private entities. The authority of the Commission to enter into such contracts is effective for
any fiscal year only to such extent or in such
amounts as are provided in advance in appropriation Acts.
(d) Informational requirements and prohibitions
(1) The Commission may secure directly from
any Federal agency information necessary to
enable it to carry out this subchapter. Upon request of the Chairman of the Commission, the
head of such agency shall furnish such information to the Commission.
(2) The Commission shall promptly arrange for
such security clearances for its members and appropriate staff as are necessary to obtain access
to classified information needed to carry out its
duties under this subchapter.
(3) The Commission shall not disclose any information reported to or otherwise obtained by
the Commission which is exempt from disclosure
under subsection (a) of section 552 of title 5 by
reason of paragraphs (4) and (6) of subsection (b)
of such section.
(e) Support services from Administrator of General Services
The Administrator of General Services shall
provide to the Commission on a reimbursable
basis such administrative support services as
the Commission may request.
(July 1, 1944, ch. 373, title XVIII, § 1803, as added
Pub. L. 95–622, title III, § 301, Nov. 9, 1978, 92 Stat.
3440.)
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.

§ 300v–3. Authorization of appropriations; termination of Commission
(a) To carry out this subchapter there are authorized to be appropriated $5,000,000 for the fiscal year ending September 30, 1979, $5,000,000 for
the fiscal year ending September 30, 1980,
$5,000,000 for the fiscal year ending September
30, 1981, and $5,000,000 for the fiscal year ending
September 30, 1982.
(b) The Commission shall be subject to the
Federal Advisory Committee Act, except that,
under section 14(a)(1)(B) of such Act, the Commission shall terminate on December 31, 1982.
(July 1, 1944, ch. 373, title XVIII, § 1804, as added
Pub. L. 95–622, title III, § 301, Nov. 9, 1978, 92 Stat.
3441.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (b), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as

§ 300w

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amended, which is set out in the Appendix to Title 5,
Government Organization and Employees.

SUBCHAPTER XVII—BLOCK GRANTS
PART A—PREVENTIVE HEALTH AND HEALTH
SERVICES BLOCK GRANTS
§ 300w. Authorization of appropriations
(a) For the purpose of allotments under section 300w–1 of this title, there are authorized to
be appropriated $205,000,000 for fiscal year 1993,
and such sums as may be necessary for each of
the fiscal years 1994 through 1998.
(b) Of the amount appropriated for any fiscal
year under subsection (a) of this section, at
least $7,000,000 shall be made available for allotments under section 300w–1(b) of this title.
(July 1, 1944, ch. 373, title XIX, § 1901, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
535; amended Pub. L. 98–555, § 4, Oct. 30, 1984, 98
Stat. 2855; Pub. L. 100–607, title III, § 301(a), Nov.
4, 1988, 102 Stat. 3111; Pub. L. 102–531, title I,
§ 101, Oct. 27, 1992, 106 Stat. 3469; Pub. L. 103–183,
title VII, § 705(e), Dec. 14, 1993, 107 Stat. 2241.)
AMENDMENTS
1993—Subsec. (a). Pub. L. 103–183 substituted
‘‘through 1998’’ for ‘‘through 1997’’.
1992—Subsec. (a). Pub. L. 102–531, § 101(a), amended
subsec. (a) generally. Prior to amendment, subsec. (a)
read as follows: ‘‘For the purpose of allotments under
section 300w–1 of this title, there is authorized to be appropriated $95,000,000 for fiscal year 1982, $96,500,000 for
fiscal year 1983, $98,500,000 for fiscal year 1984, $98,500,000
for the fiscal year ending September 30, 1985, $98,500,000
for the fiscal year ending September 30, 1986, $98,500,000
for the fiscal year ending September 30, 1987,
$110,000,000 for fiscal year 1989, and such sums as may be
necessary for each of the fiscal years 1990 and 1991.’’
Subsec. (b). Pub. L. 102–531, § 101(b), substituted
‘‘$7,000,000’’ for ‘‘$3,500,000’’.
1988—Subsec. (a). Pub. L. 100–607 struck out ‘‘and’’
after ‘‘1986,’’ and inserted ‘‘, $110,000,000 for fiscal year
1989, and such sums as may be necessary for each of the
fiscal years 1990 and 1991’’ before period at end.
1984—Subsec. (a). Pub. L. 98–555, § 4(a), inserted provisions authorizing appropriations for fiscal years ending
Sept. 30, 1985, 1986, and 1987.
Subsec. (b). Pub. L. 98–555, § 4(b), substituted
‘‘$3,500,000’’ for ‘‘$3,000,000’’.
EFFECTIVE DATE
Section 901 of Pub. L. 97–35 provided in part that this
subchapter is effective Oct. 1, 1981.

§ 300w–1. Allotments
(a) Availability based upon prior year distributions
(1) From the amounts appropriated under section 300w of this title for any fiscal year and
available for allotment under this subsection,
the Secretary shall allot to each State an
amount which bears the same ratio to the available amounts for that fiscal year as the amounts
provided by the Secretary under the provisions
of law listed in paragraph (2) to the State and
entities in the State for fiscal year 1981 bore to
the total amount appropriated for such provisions of law for fiscal year 1981.
(2) The provisions of law referred to in paragraph (1) are the following provisions of law as
in effect on September 30, 1981:

Page 1092

(A) The authority for grants under section
247b of this title for preventive health service
programs for the control of rodents.
(B) The authority for grants under section
247b of this title for establishing and maintaining community and school-based fluoridation programs.
(C) The authority for grants under section
247b of this title for preventive health service
programs for hypertension.
(D) Sections 247b–1 1 and 247b–2 of this title.
(E) Section 246(d) 1 of this title.
(F) Section 255(a) 1 of this title.
(G) Sections 300d–1,1 300d–2,1 and 300d–3 1 of
this title.
(b) Population
From the amount required to be made available under section 300w(b) of this title for allotments under this subsection for any fiscal year,
the Secretary shall make allotments to each
State on the basis of the population of the
State.
(c) Distribution of appropriated funds not allotted
To the extent that all the funds appropriated
under section 300w of this title for a fiscal year
and available for allotment in such fiscal year
are not otherwise allotted to States because—
(1) one or more States have not submitted an
application or description of activities in accordance with section 300w–4 of this title for
the fiscal year;
(2) one or more States have notified the Secretary that they do not intend to use the full
amount of their allotment; or
(3) some State allotments are offset or repaid under section 300w–5(b)(3) of this title;
such excess shall be allotted among each of the
remaining States in proportion to the amount
otherwise allotted to such States for the fiscal
year without regard to this subsection.
(d) Distributions to Indian tribes
(1) If the Secretary—
(A) receives a request from the governing
body of an Indian tribe or tribal organization
within any State that funds under this part be
provided directly by the Secretary to such
tribe or organization, and
(B) determines that the members of such
tribe or tribal organization would be better
served by means of grants made directly by
the Secretary under this part,
the Secretary shall reserve from amounts which
would otherwise be allotted to such State under
subsection (a) of this section for the fiscal year
the amount determined under paragraph (2).
(2) The Secretary shall reserve for the purpose
of paragraph (1) from amounts that would otherwise be allotted to such State under subsection
(a) of this section an amount equal to the
amount which bears the same ratio to the
State’s allotment for the fiscal year involved as
the total amount provided or allotted for fiscal
year 1981 by the Secretary to such tribe or tribal
organization under the provisions of law referred to in subsection (a) of this section bore to
1 See

References in Text note below.

Page 1093

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the total amount provided or allotted for such
fiscal year by the Secretary to the State and entities (including Indian tribes and tribal organizations) in the State under such provisions of
law.
(3) The amount reserved by the Secretary on
the basis of a determination under this subsection shall be granted to the Indian tribe or
tribal organization serving the individuals for
whom such a determination has been made.
(4) In order for an Indian tribe or tribal organization to be eligible for a grant for a fiscal year
under this subsection, it shall submit to the
Secretary a plan for such fiscal year which
meets such criteria as the Secretary may prescribe.
(5) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such
terms in section 450b(b) and (c) 2 of title 25.
(e) Report on equitable distribution of available
funds
The Secretary shall conduct a study for the
purpose of devising a formula for the equitable
distribution of funds available for allotment to
the States under this section. In conducting the
study, the Secretary shall take into account—
(1) the financial resources of the various
States,
(2) the populations of the States, and
(3) any other factor which the Secretary
may consider appropriate.
Before June 30, 1982, the Secretary shall submit
a report to the Congress respecting the development of a formula and make such recommendations as the Secretary may deem appropriate in
order to ensure the most equitable distribution
of funds under allotments under this section.
(July 1, 1944, ch. 373, title XIX, § 1902, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
535.)
REFERENCES IN TEXT
Section 247b–1 of this title, referred to in subsec.
(a)(2)(D), was in the original a reference to section 401
of the Health Services and Centers Amendments of 1978,
Pub. L. 95–626, which was repealed effective Oct. 1, 1981,
by Pub. L. 97–35, title IX, § 902(a), (h), Aug. 13, 1981, 95
Stat. 559, 561. Pub. L. 100–572, § 3, Oct. 31, 1988, 102 Stat.
2887, enacted section 317A of act July 1, 1944, which is
classified to section 247b–1 of this title.
Section 247b–2 of this title, referred to in subsec.
(a)(2)(D), was repealed effective Oct. 1, 1981, by Pub. L.
97–35, title IX, § 902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561.
Section 246(d) of this title, referred to in subsec.
(a)(2)(E), was repealed effective Oct. 1, 1981, by Pub. L.
97–35, title IX, § 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561.
Section 255 of this title, referred to in subsec.
(a)(2)(F), was in the original a reference to section 339
of act July 1, 1944, which was repealed effective Oct. 1,
1981, by Pub. L. 97–35, title IX, § 902(b), (h), Aug. 13, 1981,
95 Stat. 559, 561. Pub. L. 97–414, § 6(a), Jan. 4, 1983, 96
Stat. 2057, added a new section 339 of act July 1, 1944,
which is classified to section 255 of this title.
Sections 300d–1, 300d–2, and 300d–3 of this title, referred to in subsec. (a)(2)(G), were in the original references to sections 1202, 1203, and 1204, respectively, of
act July 1, 1944, which were repealed effective Oct. 1,
1981, by Pub. L. 97–35, title IX, § 902(d)(1), (h), Aug. 13,
1981, 95 Stat. 560, 561. Pub. L. 101–590, § 3, Nov. 16, 1990,
104 Stat. 2916–2918, enacted new sections 1202, 1203, and
2 See

References in Text note below.

§ 300w–3

1204 of act July 1, 1944, which were classified to sections
300d–1, 300d–2, and 300d–3, respectively, of this title.
Pub. L. 103–183, title VI, § 601(b), Dec. 14, 1983, 107 Stat.
2238, repealed section 1202 and renumbered sections 1203
and 1204 as 1202 and 1203, respectively. Pub. L. 110–23,
§§ 3, 5, May 3, 2007, 121 Stat. 90, 91, repealed section 1202,
renumbered section 1203 as 1202, and enacted new section 1203 of act July 1, 1944, which is classified to section 300d–5 of this title.
Section 450b of title 25, referred to in subsec. (d)(5),
has been amended, and subsecs. (b) and (c) of section
450b no longer define the terms ‘‘Indian tribe’’ and
‘‘tribal organization’’. However, such terms are defined
elsewhere in that section.

§ 300w–2. Payments under allotments to States
(a)(1) For each fiscal year, the Secretary shall
make payments, as provided by section 6503(a) of
title 31, to each State from its allotment under
section 300w–1 of this title (other than any
amount reserved under section 300w–1(d) of this
title) from amounts appropriated for that fiscal
year.
(2) Any amount paid to a State for a fiscal
year and remaining unobligated at the end of
such year shall remain available for the next fiscal year to such State for the purposes for which
it was made.
(b) The Secretary, at the request of a State,
may reduce the amount of payments under subsection (a) of this section by—
(1) the fair market value of any supplies or
equipment furnished the State, and
(2) the amount of the pay, allowances, and
travel expenses of any officer or employee of
the Government when detailed to the State
and the amount of any other costs incurred in
connection with the detail of such officer or
employee,
when the furnishing of supplies or equipment or
the detail of an officer or employee is for the
convenience of and at the request of the State
and for the purpose of conducting activities described in section 300w–3 of this title. The
amount by which any payment is so reduced
shall be available for payment by the Secretary
of the costs incurred in furnishing the supplies
or equipment or in detailing the personnel, on
which the reduction of the payment is based,
and the amount shall be deemed to be part of
the payment and shall be deemed to have been
paid to the State.
(July 1, 1944, ch. 373, title XIX, § 1903, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
537.)
CODIFICATION
In subsec. (a)(1), ‘‘section 6503(a) of title 31’’ substituted for ‘‘section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213)’’ on authority of
Pub. L. 97–258, § 4(b), Sept. 13, 1982, 96 Stat. 1067, the
first section of which enacted Title 31, Money and Finance.

§ 300w–3. Use of allotments
(a) Preventive health services, comprehensive
public health services, emergency medical
services, etc.
(1) Except as provided in subsections (b) and
(c) of this section, payments made to a State
under section 300w–2 of this title may be used for
the following:

§ 300w–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) Activities consistent with making
progress toward achieving the objectives established by the Secretary for the health
status of the population of the United States
for the year 2000 (in this part referred to as
‘‘year 2000 health objectives’’).
(B) Preventive health service programs for
the control of rodents and for community and
school-based fluoridation programs.
(C) Feasibility studies and planning for
emergency medical services systems and the
establishment, expansion, and improvement of
such systems. Amounts for such systems may
not be used for the costs of the operation of
the systems or the purchase of equipment for
the systems, except that such amounts may be
used for the payment of not more than 50 percent of the costs of purchasing communications equipment for the systems. Amounts
may be expended for feasibility studies or
planning for the trauma-care components of
such systems only if the studies or planning,
respectively, is consistent with the requirements of section 300d–13(a) of this title.
(D) Providing services to victims of sex offenses and for prevention of sex offenses.
(E) The establishment, operation, and coordination of effective and cost-efficient systems to reduce the prevalence of illness due to
asthma and asthma-related illnesses, especially among children, by reducing the level of
exposure to cockroach allergen or other
known asthma triggers through the use of integrated pest management, as applied to cockroaches or other known allergens. Amounts
expended for such systems may include the
costs of building maintenance and the costs of
programs to promote community participation in the carrying out at such sites of integrated pest management, as applied to cockroaches or other known allergens. For purposes of this subparagraph, the term ‘‘integrated pest management’’ means an approach
to the management of pests in public facilities
that combines biological, cultural, physical,
and chemical tools in a way that minimizes
economic, health, and environmental risks.
(F) With respect to activities described in
any of subparagraphs (A) through (E), related
planning, administration, and educational activities.
(G) Monitoring and evaluation of activities
carried out under any of subparagraphs (A)
through (F).
(2) Except as provided in subsection (b) of this
section, amounts paid to a State under section
300w–2 of this title from its allotment under section 300w–1(b) of this title may only be used for
providing services to rape victims and for rape
prevention.
(3) The Secretary may provide technical assistance to States in planning and operating activities to be carried out under this part.
(b) Prohibited uses
A State may not use amounts paid to it under
section 300w–2 of this title to—
(1) provide inpatient services,
(2) make cash payments to intended recipients of health services,
(3) purchase or improve land, purchase, construct, or permanently improve (other than

Page 1094

minor remodeling) any building or other facility, or purchase major medical equipment,
(4) satisfy any requirement for the expenditure of non-Federal funds as a condition for
the receipt of Federal funds, or
(5) provide financial assistance to any entity
other than a public or nonprofit private entity.
Except as provided in subsection (a)(1)(E) of this
section, the Secretary may waive the limitation
contained in paragraph (3) upon the request of a
State if the Secretary finds that there are extraordinary circumstances to justify the waiver
and that granting the waiver will assist in carrying out this part.
(c) Transfer of funds
A State may transfer not more than 7 percent
of the amount allotted to the State under section 300w–1(a) of this title for any fiscal year for
use by the State under part B of this subchapter
and title V of the Social Security Act [42 U.S.C.
701 et seq.] in such fiscal year as follows: At any
time in the first three quarters of the fiscal year
a State may transfer not more than 3 percent of
the allotment of the State for the fiscal year for
such use, and in the last quarter of a fiscal year
a State may transfer for such use not more than
the remainder of the amount of its allotment
which may be transferred.
(d) Limitation on administrative costs
Of the amount paid to any State under section
300w–2 of this title, not more than 10 percent
paid from each of its allotments under subsections (a) and (b) of section 300w–1 of this title
may be used for administering the funds made
available under section 300w–2 of this title. The
State will pay from non-Federal sources the remaining costs of administering such funds.
(July 1, 1944, ch. 373, title XIX, § 1904, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
537; amended Pub. L. 97–414, § 8(s), Jan. 4, 1983, 96
Stat. 2062; Pub. L. 99–646, § 87(d)(1)(A), Nov. 10,
1986, 100 Stat. 3623; Pub. L. 99–654, § 3(b)(1)(A),
Nov. 14, 1986, 100 Stat. 3663; Pub. L. 100–607, title
III, § 301(b), Nov. 4, 1988, 102 Stat. 3111; Pub. L.
102–531, title I, § 102, Oct. 27, 1992, 106 Stat. 3470;
Pub. L. 106–310, div. A, title V, § 511, Oct. 17, 2000,
114 Stat. 1116.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (c), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title
V of the Social Security Act is classified generally to
subchapter V (§ 701 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
AMENDMENTS
2000—Subsec. (a)(1)(E). Pub. L. 106–310, § 511(3), added
subpar. (E). Former subpar. (E) redesignated (F).
Subsec. (a)(1)(F). Pub. L. 106–310, § 511(1), (4), redesignated subpar. (E) as (F) and substituted ‘‘subparagraphs (A) through (E)’’ for ‘‘subparagraphs (A) through
(D)’’. Former subpar. (F) redesignated (G).
Subsec. (a)(1)(G). Pub. L. 106–310, § 511(1), (2), (5), redesignated subpar. (F) as (G) and substituted ‘‘subparagraphs (A) through (F).’’ for ‘‘subparagraphs (A)
through (E)’’.
1992—Subsec. (a)(1). Pub. L. 102–531, § 102(a), amended
par. (1) generally, substituting present provisions for
provisions authorizing, except as provided in subsecs.

Page 1095

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) and (c), use of the amounts paid to a State under
section 300w–2 of this title from its allotment under
section 300w–1(a) of this title and amounts transferred
by the State, for use in preventive health service programs, including hypertension and high cholesterol
services, health-risk reduction programs, immunization services, home health agencies, emergency medical services, services to victims of sex offenses, and
uterine cancer and breast cancer services.
Subsec. (c). Pub. L. 102–531, § 102(b), substituted ‘‘part
B’’ for ‘‘parts B and C’’.
1988—Subsec. (a)(1)(B). Pub. L. 100–607, § 301(b)(1), inserted ‘‘and elevated serum cholesterol’’ before period
at end.
Subsec. (a)(1)(C). Pub. L. 100–607, § 301(b)(2), inserted
‘‘, including programs designed to reduce the incidence
of chronic diseases’’ before period at end.
Subsec. (a)(1)(D). Pub. L. 100–607, § 301(b)(3), inserted
‘‘, including immunization services’’ before period at
end.
Subsec. (a)(1)(F). Pub. L. 100–607, § 301(b)(4), substituted ‘‘systems, except that such amounts may be
used for the payment of not more than 50 percent of the
costs of purchasing communications equipment for the
systems’’ for ‘‘systems (other than systems with respect to which grants were made as prescribed by section 300w–4(c)(2) of this title)’’.
Subsec. (a)(1)(H). Pub. L. 100–607, § 301(b)(5), added
subpar. (H).
1986—Subsec. (a)(1)(G). Pub. L. 99–646 and Pub. L.
99–654 amended subpar. (G) identically, substituting
‘‘victims of sex offenses and for prevention of sex offenses’’ for ‘‘rape victims and for rape prevention’’.
1983—Subsec. (a)(1)(F). Pub. L. 97–414 inserted ‘‘(other
than systems with respect to which grants were made
as prescribed by section 300w–4(c)(2) of this title)’’ after
‘‘equipment for the systems’’.
EFFECTIVE DATE OF 1986 AMENDMENTS
Amendments by Pub. L. 99–646 and Pub. L. 99–654 effective 30 days after Nov. 10, 1986, and 30 days after Nov.
14, 1986, respectively, see section 87(e) of Pub. L. 99–646
and section 4 of Pub. L. 99–654, set out as an Effective
Date note under section 2241 of Title 18, Crimes and
Criminal Procedure.

§ 300w–4. Application for payments; State plan
(a) In general
The Secretary may make payments under section 300w–2 of this title to a State for a fiscal
year only if—
(1) the State submits to the Secretary an application for the payments;
(2) the application contains a State plan in
accordance with subsection (b) of this section;
(3) the application contains the certification
described in subsection (c) of this section;
(4) the application contains such assurances
as the Secretary may require regarding the
compliance of the State with the requirements
of this part (including assurances regarding
compliance with the agreements described in
subsection (c) of this section); and
(5) the application is in such form and is submitted by such date as the Secretary may require.
(b) State plan
A State plan required in subsection (a)(2) of
this section for a fiscal year is in accordance
with this subsection if the plan meets the following conditions:
(1) The plan is developed by the State agency with principal responsibility for public
health programs, in consultation with the ad-

§ 300w–4

visory committee established pursuant to subsection (c)(2) of this section.
(2) The plan specifies the activities authorized in section 300w–3 of this title that are to
be carried out with payments made to the
State under section 300w–2 of this title, including a specification of the year 2000 health objectives for which the State will expend the
payments.
(3) The plan specifies the populations in the
State for which such activities are to be carried out.
(4) The plan specifies any populations in the
State that have a disparate need for such activities.
(5) With respect to each population specified
under paragraph (3), the plan contains a strategy for expending such payments to carry out
such activities to make progress toward improving the health status of the population,
which strategy includes—
(A) a description of the programs and
projects to be carried out;
(B) an estimate of the number of individuals to be served by the programs and
projects; and
(C) an estimate of the number of public
health personnel needed to carry out the
strategy.
(6) The plan specifies the amount of such
payments to be expended for each of such activities and, with respect to the activity involved—
(A) the amount to be expended for each
population specified under paragraph (3); and
(B) the amount to be expended for each
population specified under paragraph (4).
(c) State certification
The certification referred to in subsection
(a)(3) of this section for a fiscal year is a certification to the Secretary by the chief executive
officer of the State involved as follows:
(1)(A) In the development of the State plan
required in subsection (a)(2) of this section—
(i) the chief health officer of the State held
public hearings on the plan; and
(ii) proposals for the plan were made public in a manner that facilitated comments
from public and private entities (including
Federal and other public agencies).
(B) The State agrees that, if any revisions
are made in such plan during the fiscal year,
the State will, with respect to the revisions,
hold hearings and make proposals public in accordance with subparagraph (A), and will submit to the Secretary a description of the revisions.
(2) The State has established an advisory
committee in accordance with subsection (d)
of this section.
(3) The State agrees to expend payments
under section 300w–2 of this title only for the
activities authorized in section 300w–3 of this
title.
(4) The State agrees to expend such payments in accordance with the State plan submitted under subsection (a)(2) of this section
(with any revisions submitted to the Secretary under paragraph (1)(B)), including mak-

§ 300w–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing expenditures to carry out the strategy
contained in the plan pursuant to subsection
(b)(5) of this section.
(5)(A) The State agrees that, in the case of
each population for which such strategy is carried out, the State will measure the extent of
progress being made toward improving the
health status of the population.
(B) The State agrees that—
(i) the State will collect and report data in
accordance with section 300w–5(a) of this
title; and
(ii) for purposes of subparagraph (A),
progress will be measured through use of
each of the applicable uniform data items
developed by the Secretary under paragraph
(2) of such section, or if no such items are
applicable, through use of the uniform criteria developed by the Secretary under paragraph (3) of such section.
(6) With respect to the activities authorized
in section 300w–3 of this title, the State agrees
to maintain State expenditures for such activities at a level that is not less than the average level of such expenditures maintained by
the State for the 2-year period preceding the
fiscal year for which the State is applying to
receive payments under section 300w–2 of this
title.
(7) The State agrees to establish reasonable
criteria to evaluate the effective performance
of entities that receive funds from such payments and procedures for procedural and substantive independent State review of the failure by the State to provide funds for any such
entity.
(8) The State agrees to permit and cooperate
with Federal investigations undertaken in accordance with section 300w–6 of this title.
(9) The State has in effect a system to protect from inappropriate disclosure patient and
sex offense victim records maintained by the
State in connection with an activity funded
under this part or by any entity which is receiving payments from the allotment of the
State under this part.
(10) The State agrees to provide the officer
of the State government responsible for the
administration of the State highway safety
program with an opportunity to—
(A) participate in the development of any
plan by the State relating to emergency
medical services, as such plan relates to
highway safety; and
(B) review and comment on any proposal
by any State agency to use any Federal
grant or Federal payment received by the
State for the provision of emergency medical services as such proposal relates to highway safety.
(d) State Advisory Committee
(1) In general
For purposes of subsection (c)(2) of this section, an advisory committee is in accordance
with this subsection if such committee is
known as the State Preventive Health Advisory Committee (in this subsection referred to
as the ‘‘Committee’’) and the Committee
meets the conditions described in the subsequent paragraphs of this subsection.

Page 1096

(2) Duties
A condition under paragraph (1) for a State
is that the duties of the Committee are—
(A) to hold public hearings on the State
plan required in subsection (a)(2) of this section; and
(B) to make recommendations pursuant to
subsection (b)(1) of this section regarding
the development and implementation of
such plan, including recommendations on—
(i) the conduct of assessments of the public health;
(ii) which of the activities authorized in
section 300w–3 of this title should be carried out in the State;
(iii) the allocation of payments made to
the State under section 300w–2 of this title;
(iv) the coordination of activities carried
out under such plan with relevant programs of other entities; and
(v) the collection and reporting of data
in accordance with section 300w–5(a) of
this title.
(3) Composition
(A) A condition under paragraph (1) for a
State is that the Committee is composed of
such members of the general public, and such
officials of the health departments of political
subdivisions of the State, as may be necessary
to provide adequate representation of the general public and of such health departments.
(B) With respect to compliance with subparagraph (A), the membership of advisory
committees established pursuant to subsection (c)(2) of this section may include representatives of community-based organizations (including minority community-based
organizations), schools of public health, and
entities to which the State involved awards
grants or contracts to carry out activities authorized in section 300w–3 of this title.
(4) Chair; meetings
A condition under paragraph (1) for a State
is that the State public health officer serves
as the chair of the Committee, and that the
Committee meets not less than twice each fiscal year.
(July 1, 1944, ch. 373, title XIX, § 1905, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
538; amended Pub. L. 98–555, § 5(a), (d), Oct. 30,
1984, 98 Stat. 2855, 2856; Pub. L. 99–646,
§ 87(d)(1)(B), Nov. 10, 1986, 100 Stat. 3624; Pub. L.
99–654, § 3(b)(1)(B), Nov. 14, 1986, 100 Stat. 3663;
Pub. L. 100–607, title III, § 301(c), Nov. 4, 1988, 102
Stat. 3112; Pub. L. 101–590, § 4, Nov. 16, 1990, 104
Stat. 2928; Pub. L. 102–531, title I, § 103(a), Oct. 27,
1992, 106 Stat. 3470.)
AMENDMENTS
1992—Pub. L. 102–531 amended section generally, substituting present provisions for provisions relating to
submission and form of application for assistance under
this part as well as required assurances, public hearings
on proposed use and distribution of funds, certifications
by chief executive officer of State, and a description of
intended use of funds as well as public access to and revision of such description.
1990—Subsec. (c). Pub. L. 101–590, which directed
amendment of subsec. (c) by adding at the end thereof
a new par. (7), was executed by adding par. (7) after par.

Page 1097

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) and before the last sentence to reflect the probable
intent of Congress.
1988—Subsec. (d). Pub. L. 100–607 inserted at end ‘‘The
description shall include a statement of the public
health objectives expected to be achieved by the State
through the use of the payments the State will receive
under section 300w–2 of this title.’’
1986—Subsec. (c)(6). Pub. L. 99–646 and Pub. L. 99–654
amended par. (6) identically, substituting ‘‘sex offense’’
for ‘‘rape’’.
1984—Subsec. (c)(2). Pub. L. 98–555, § 5(a), redesignated
par. (3) as (2). Former par. (2), which related to grants
for fiscal year 1982, was struck out.
Subsec. (c)(3). Pub. L. 98–555, § 5(a), redesignated par.
(5) as (3). Former par. (3) redesignated (2).
Subsec. (c)(4). Pub. L. 98–555, § 5(a), redesignated par.
(6) as (4). Former par. (4), which related to grants for
preventive health service programs for hypertension,
was struck out.
Subsec. (c)(5) to (8). Pub. L. 98–555, § 5(a), redesignated
pars. (7) and (8) as (5) and (6), respectively. Former pars.
(5) and (6) redesignated (3) and (4), respectively.
Subsec. (e). Pub. L. 98–555, § 5(d), struck out subsec.
(e) which related to grants by States.
EFFECTIVE DATE OF 1986 AMENDMENTS
Amendments by Pub. L. 99–646 and Pub. L. 99–654 effective 30 days after Nov. 10, 1986, and 30 days after Nov.
14, 1986, respectively, see section 87(e) of Pub. L. 99–646
and section 4 of Pub. L. 99–654, set out as an Effective
Date note under section 2241 of Title 18, Crimes and
Criminal Procedure.
DELAYED APPLICABILITY OF REQUIREMENT REGARDING
ADVISORY COMMITTEES
Section 103(b) of Pub. L. 102–531 provided that: ‘‘With
respect to compliance with the requirement established
in subsection (c)(2) of section 1905 of the Public Health
Service Act [subsec. (c)(2) of this section] (as amended
by subsection (a) of this section), a State is deemed,
notwithstanding such section, to be in compliance with
such requirement if the State establishes an advisory
committee in accordance with subsection (d) of such
section not later than 180 days after the date of the enactment of this Act [Oct. 27, 1992].’’

§ 300w–5. Reports, data, and audits
(a) Annual reports; contents; data collection; copies
(1) For purposes of section 300w–4(c)(5)(B)(i) of
this title, a State is collecting and reporting
data for a fiscal year in accordance with this
subsection if the State submits to the Secretary, not later than February 1 of the succeeding fiscal year, a report that—
(A) describes the purposes for which the
State expended payments made to the State
under section 300w–2 of this title;
(B) pursuant to section 300w–4(c)(5)(A) of
this title, describes the extent of progress
made by the State for purposes of such section;
(C) meets the conditions described in the
subsequent paragraphs of this subsection; and
(D) contains such additional information regarding activities authorized in section 300w–3
of this title, and is submitted in such form, as
the Secretary may require.
(2)(A) The Secretary, in consultation with the
States, shall develop sets of data for uniformly
defining health status for purposes of the year
2000 health objectives (which sets are in this
subsection referred to as ‘‘uniform data sets’’).
Each of such sets shall consist of one or more

§ 300w–5

categories of information (in this subsection individually referred to as a ‘‘uniform data item’’).
The Secretary shall develop formats for the uniform collecting and reporting of information on
such items.
(B) A condition under paragraph (1)(C) for a
fiscal year is that the State involved will, in accordance with the applicable format under subparagraph (A), collect during such year, and include in the report under paragraph (1), the necessary information for one uniform data item
from each of the uniform data sets, which items
are selected for the State by the Secretary.
(C) In the case of fiscal year 1995 and each subsequent fiscal year, a condition under paragraph
(1) for a State is that the State will, in accordance with the applicable format under subparagraph (A), collect during such year, and include
in the report under paragraph (1), the necessary
information for each of the uniform data sets
appropriate to the year 2000 health objectives
that the State has, in the State plan submitted
under section 300w–4 of this title for the fiscal
year, specified as a purpose for which payments
under section 300w–2 of this title are to be expended.
(3) The Secretary, in consultation with the
States, shall establish criteria for the uniform
collection and reporting of data on activities authorized in section 300w–3 of this title with respect to which no uniform data items exist.
(4) A condition under paragraph (1) for a fiscal
year is that the State involved will make copies
of the report submitted under such paragraph
for the fiscal year available for public inspection, and will upon request provide a copy of the
report to any individual for a charge not exceeding the cost of providing the copy.
(b) Fiscal control; accounting procedures; annual
audits; repayments and offsets; public inspection; Comptroller General evaluations;
report to Congress
(1) Each State shall establish fiscal control
and fund accounting procedures as may be necessary to assure the proper disbursal of and accounting for Federal funds paid to the State
under section 300w–2 of this title and funds
transferred under section 300w–3(c) of this title
for use under this part.
(2) Each State shall annually audit its expenditures from payments received under section
300w–2 of this title. Such State audits shall be
conducted by an entity independent of any agency administering a program funded under this
part and, in so far as practical, in accordance
with the Comptroller General’s standards for auditing governmental organizations, programs,
activities, and functions. Within 30 days following the date each audit is completed, the chief
executive officer of the State shall transmit a
copy of that audit to the Secretary.
(3) Each State shall, after being provided by
the Secretary with adequate notice and opportunity for a hearing within the State, repay to
the United States amounts found not to have
been expended in accordance with the requirements of this part or the certification provided
by the State under section 300w–4 of this title. If
such repayment is not made, the Secretary
shall, after providing the State with adequate

§ 300w–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

notice and opportunity for a hearing within the
State, offset such amounts against the amount
of any allotment to which the State is or may
become entitled under this part.
(4) The State shall make copies of the reports
and audits required by this section available for
public inspection within the State.
(5) The Comptroller General of the United
States shall, from time to time, evaluate the expenditures by States of grants under this part in
order to assure that expenditures are consistent
with the provisions of this part and the certification provided by the State under section
300w–4 of this title.
(6) Not later than October 1, 1990, the Secretary shall report to the Congress on the activities of the States that have received funds under
this part and may include in the report any recommendations for appropriate changes in legislation.
(c) Inapplicability of title XVII of Omnibus Budget Reconciliation Act of 1981
Title XVII of the Omnibus Budget Reconciliation Act of 1981 shall not apply with respect to
audits of funds allotted under this part.
(July 1, 1944, ch. 373, title XIX, § 1906, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
540; amended Pub. L. 98–555, § 5(b), (c), Oct. 30,
1984, 98 Stat. 2855, 2856; Pub. L. 100–607, title III,
§ 301(d), Nov. 4, 1988, 102 Stat. 3112; Pub. L.
102–531, title I, § 104, Oct. 27, 1992, 106 Stat. 3473.)
REFERENCES IN TEXT
The Omnibus Budget Reconciliation Act of 1981, referred to in subsec. (c), is Pub. L. 97–35, Aug. 13, 1981, 95
Stat. 357, as amended. Title XVII of the Omnibus Budget Reconciliation Act of 1981 enacted sections 3595, and
4511 to 4514 of Title 5, Government Organization and
Employees, amended sections 3393, 3593, 3596, 4501, 4502,
4505, 4506, 7542, 7543, 8340, and 8345 of Title 5, and sections 2003 and 2401 of Title 39, Postal Service, and enacted provisions set out as notes under sections 3595,
4501, 5303, 5343, 8340, and 8345 of Title 5, section 1243 of
former Title 31, Money and Finance, and sections 403,
2003, 2004, and 2401 of Title 39. For complete classification of this Act to the Code, see Tables.
AMENDMENTS
1992—Pub. L. 102–531, § 104(b)(1), substituted ‘‘Reports,
data, and audits’’ for ‘‘Reports and audits’’ in section
catchline.
Subsec. (a). Pub. L. 102–531, § 104(a), amended subsec.
(a) generally, substituting present provisions for provisions requiring an annual report by each State of its
activities under this part, outlining the contents of
such report, and for providing copies of the report to
interested persons.
Subsec. (d). Pub. L. 102–531, § 104(b)(2), struck out subsec. (d) which provided for development of model criteria and forms for collection of data and information
on services provided under this part.
1988—Subsec. (a)(3). Pub. L. 100–607, § 301(d)(1), added
par. (3).
Subsec. (b)(6). Pub. L. 100–607, § 301(d)(2), substituted
‘‘1990’’ for ‘‘1983’’.
1984—Subsec. (a)(1)(B). Pub. L. 98–555, § 5(b), substituted ‘‘preventive health and preventive health services programs in the State assisted by funds from allotments under this part, including a summary of the
services which were provided, the providers of such
services, and the individuals who received such services’’ for ‘‘activities of the State under this part’’.
Subsec. (d). Pub. L. 98–555, § 5(c), added subsec. (d).

Page 1098

§ 300w–6. Withholding of funds
(a) Prerequisites
(1) The Secretary shall, after adequate notice
and an opportunity for a hearing conducted
within the affected State, withhold funds from
any State which does not use its allotment in
accordance with the requirements of this part or
the certification provided under section 300w–4
of this title. The Secretary shall withhold such
funds until the Secretary finds that the reason
for the withholding has been removed and there
is reasonable assurance that it will not recur.
(2) The Secretary may not institute proceedings to withhold funds under paragraph (1) unless the Secretary has conducted an investigation concerning whether the State has used its
allotment in accordance with the requirements
of this part or the certification provided under
section 300w–4 of this title. Investigations required by this paragraph shall be conducted
within the affected State by qualified investigators.
(3) The Secretary shall respond in an expeditious manner to complaints of a substantial or
serious nature that a State has failed to use
funds in accordance with the requirements of
this part or certifications provided under section 300w–4 of this title.
(4) The Secretary may not withhold funds
under paragraph (1) from a State for a minor
failure to comply with the requirements of this
part or certifications provided under section
300w–4 of this title.
(b) Investigations
(1) The Secretary shall conduct in several
States in each fiscal year investigations of the
use of funds received by the States under this
part in order to evaluate compliance with the
requirements of this part and certifications provided under section 300w–4 of this title.
(2) The Comptroller General of the United
States may conduct investigations of the use of
funds received under this part by a State in
order to insure compliance with the requirements of this part and certifications provided
under section 300w–4 of this title.
(c) Availability of books, documents, papers, and
records
Each State, and each entity which has received funds from an allotment made to a State
under this part, shall make appropriate books,
documents, papers, and records available to the
Secretary or the Comptroller General of the
United States, or any of their duly authorized
representatives, for examination, copying, or
mechanical reproduction on or off the premises
of the appropriate entity upon a reasonable request therefor.
(d) Information not readily available
(1) In conducting any investigation in a State,
the Secretary or the Comptroller General of the
United States may not make a request for any
information not readily available to such State
or an entity which has received funds from an
allotment made to the State under this part or
make an unreasonable request for information
to be compiled, collected, or transmitted in any
form not readily available.

Page 1099

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Paragraph (1) does not apply to the collection, compilation, or transmittal of data in the
course of a judicial proceeding.
(July 1, 1944, ch. 373, title XIX, § 1907, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
541.)
§ 300w–7. Nondiscrimination provisions
(a) Programs and activities receiving Federal financial assistance
(1) For the purpose of applying the prohibitions against discrimination on the basis of age
under the Age Discrimination Act of 1975 [42
U.S.C. 6101 et seq.], on the basis of handicap
under section 504 of the Rehabilitation Act of
1973 [29 U.S.C. 794], on the basis of sex under
title IX of the Education Amendments of 1972 [20
U.S.C. 1681 et seq.], or on the basis of race, color,
or national origin under title VI of the Civil
Rights Act of 1964 [42 U.S.C. 2000d et seq.], programs and activities funded in whole or in part
with funds made available under this part are
considered to be programs and activities receiving Federal financial assistance.
(2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity funded in
whole or in part with funds made available
under this part.
(b) Failure to comply
Whenever the Secretary finds that a State, or
an entity that has received a payment from an
allotment to a State under section 300w–1 of this
title, has failed to comply with a provision of
law referred to in subsection (a)(1) of this section, with subsection (a)(2) of this section, or
with an applicable regulation (including one prescribed to carry out subsection (a)(2) of this section), the Secretary shall notify the chief executive officer of the State and shall request him to
secure compliance. If within a reasonable period
of time, not to exceed sixty days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
(1) refer the matter to the Attorney General
with a recommendation that an appropriate
civil action be instituted,
(2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964
[42 U.S.C. 2000d et seq.], the Age Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], or section 504 of the Rehabilitation Act of 1973 [29
U.S.C. 794], as may be applicable, or
(3) take such other action as may be provided by law.
(c) Civil actions by Attorney General
When a matter is referred to the Attorney
General pursuant to subsection (b)(1) of this section, or whenever he has reason to believe that
a State or an entity is engaged in a pattern or
practice in violation of a provision of law referred to in subsection (a)(1) of this section or in
violation of subsection (a)(2) of this section, the
Attorney General may bring a civil action in
any appropriate district court of the United
States for such relief as may be appropriate, including injunctive relief.

§ 300w–9

(July 1, 1944, ch. 373, title XIX, § 1908, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
542.)
REFERENCES IN TEXT
The Age Discrimination Act of 1975, referred to in
subsecs. (a)(1) and (b)(2), is title III of Pub. L. 94–135,
Nov. 28, 1975, 89 Stat. 728, as amended, which is classified generally to chapter 76 (§ 6101 et seq.) of this title.
For complete classification of this Act to the Code, see
Short Title note set out under section 6101 of this title
and Tables.
The Education Amendments of 1972, referred to in
subsec. (a)(1), is Pub. L. 92–318, June 23, 1972, 86 Stat.
235, as amended. Title IX of the Act, known as the
Patsy Takemoto Mink Equal Opportunity in Education
Act, is classified principally to chapter 38 (§ 1681 et seq.)
of Title 20, Education. For complete classification of
title IX to the Code, see Short Title note set out under
section 1681 of Title 20 and Tables.
The Civil Rights Act of 1964, referred to in subsecs.
(a)(1) and (b)(2), is Pub. L. 88–352, July 2, 1964, 78 Stat.
241, as amended. Title VI of the Civil Rights Act of 1964
is classified generally to subchapter V (§ 2000d et seq.)
of chapter 21 of this title. For complete classification
of this Act to the Code, see Short Title note set out
under section 2000a of this title and Tables.

§ 300w–8. Criminal penalty for false statements
Whoever—
(1) knowingly and willfully makes or causes
to be made any false statement or representation of a material fact in connection with the
furnishing of items or services for which payment may be made by a State from funds allotted to the State under this part, or
(2) having knowledge of the occurrence of
any event affecting his initial or continued
right to any such payment conceals or fails to
disclose such event with an intent fraudulently to secure such payment either in a
greater amount than is due or when no such
payment is authorized,
shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
(July 1, 1944, ch. 373, title XIX, § 1909, as added
Pub. L. 97–35, title IX, § 901, Aug. 13, 1981, 95 Stat.
542.)
§ 300w–9. Emergency medical services for children
(a) Grant authority
For activities in addition to the activities
which may be carried out by States under section 300w–3(a)(1)(F) 1 of this title, the Secretary
may make grants to States or accredited
schools of medicine in States to support a program of demonstration projects for the expansion and improvement of emergency medical
services for children who need treatment for
trauma or critical care. Any grant made under
this subsection shall be for not more than a 4year period (with an optional 5th year based on
performance), subject to annual evaluation by
the Secretary. Only 3 grants under this subsection may be made in a State (to a State or to
a school of medicine in such State) in any fiscal
year.
(b) Renewals
The Secretary may renew a grant made under
subsection (a) of this section for one additional
1 See

References in Text note below.

§ 300w–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

one-year period only if the Secretary determines
that renewal of such grant will provide significant benefits through the collection, analysis,
and dissemination of information or data which
will be useful to States in which grants under
such subsection have not been made.
(c) Definitions
For purposes of this section—
(1) the term ‘‘school of medicine’’ has the
same meaning as in section 292a(4) 1 of this
title; and
(2) the term ‘‘accredited’’ has the same
meaning as in section 292a(5) 1 of this title.
(d) Authorization of appropriations
To carry out this section, there are authorized
to be appropriated $2,000,000 for fiscal year 1985
and for each of the two succeeding fiscal years,
$3,000,000 for fiscal year 1989, $4,000,000 for fiscal
year 1990, $5,000,000 for each of the fiscal years
1991 and 1992, such sums as may be necessary for
each of the fiscal years 1993 through 2005,
$25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500 for fiscal year 2012,
$28,940,625 for fiscal year 2013, and $30,387,656 for
fiscal year 2014.
(July 1, 1944, ch. 373, title XIX, § 1910, as added
Pub. L. 98–555, § 7, Oct. 30, 1984, 98 Stat. 2856;
amended Pub. L. 99–272, title XVII, § 17004, Apr.
7, 1986, 100 Stat. 360; Pub. L. 100–607, title III,
§ 302, Nov. 4, 1988, 102 Stat. 3112; Pub. L. 101–590,
§ 5, Nov. 16, 1990, 104 Stat. 2928; Pub. L. 102–410,
§ 11, Oct. 13, 1992, 106 Stat. 2101; Pub. L. 105–392,
title IV, § 415, Nov. 13, 1998, 112 Stat. 3590; Pub. L.
111–148, title V, § 5603, Mar. 23, 2010, 124 Stat. 679.)
REFERENCES IN TEXT
Section 300w–3(a)(1) of this title, referred to in subsec.
(a), was amended generally by Pub. L. 102–531, title I,
§ 102(a), Oct. 27, 1992, 106 Stat. 3470, and, as so amended,
provisions formerly appearing in subpar. (F) are contained in subpar. (C).
Section 292a of this title, referred to in subsec. (c),
was in the original a reference to section 701 of act July
1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702,
relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see section 295p of this title.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 5603(1), substituted
‘‘4-year period (with an optional 5th year’’ for ‘‘3-year
period (with an optional 4th year’’.
Subsec. (d). Pub. L. 111–148, § 5603(2), substituted
‘‘such sums’’ for ‘‘and such sums’’ and inserted
‘‘, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal
year 2011, $27,562,500 for fiscal year 2012, $28,940,625 for
fiscal year 2013, and $30,387,656 for fiscal year 2014’’ before period at end.
1998—Subsec. (a). Pub. L. 105–392, § 415(1), substituted
‘‘3-year period (with an optional 4th year based on performance)’’ for ‘‘two-year period’’ and ‘‘3 grants’’ for
‘‘one grant’’.
Subsec. (d). Pub. L. 105–392, § 415(2), substituted ‘‘2005’’
for ‘‘1997’’.
1992—Subsec. (a). Pub. L. 102–410, § 11(1), substituted
‘‘grants’’ for ‘‘not more than four grants in any fiscal
year’’ after ‘‘Secretary may make’’ in first sentence.
Subsec. (d). Pub. L. 102–410, § 11(2), substituted
‘‘$5,000,000’’ for ‘‘and $5,000,000’’ and inserted before pe-

Page 1100

riod ‘‘, and such sums as may be necessary for each of
the fiscal years 1993 through 1997’’.
1990—Subsec. (a). Pub. L. 101–590, § 5(1)(A), which directed the substitution of ‘‘grants’’ for ‘‘not more that
four grants in any fiscal year’’ could not be executed
because the language to be stricken did not appear in
text.
Pub. L. 101–590, § 5(1)(B), struck out ‘‘in such States’’
after ‘‘demonstration projects’’ in first sentence.
Subsec. (d). Pub. L. 101–590, § 5(2), substituted ‘‘each of
the fiscal years 1991 and 1992’’ for ‘‘fiscal year 1991’’.
1988—Subsec. (a). Pub. L. 100–607, § 302(a), substituted
‘‘shall be for not more than a two-year period, subject
to annual evaluation by the Secretary’’ for ‘‘shall be
for a one-year period’’.
Subsec. (d). Pub. L. 100–607, § 302(b), inserted
‘‘, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year
1990, and $5,000,000 for fiscal year 1991’’ before period at
end.
1986—Subsec. (a). Pub. L. 99–272, § 17004(1), which directed substitution of ‘‘not more than four grants in
any fiscal year to States or accredited schools of medicine in States’’ for ‘‘grant to not more than four States
in any fiscal year’’ was made by substituting former
phrase for ‘‘grants to not more than four States in any
fiscal year’’, as the probable intent of Congress.
Pub. L. 99–272, § 17004(2), inserted at end ‘‘Only one
grant under this subsection may be made in a State (to
a State or to a school of medicine in such State) in any
fiscal year.’’
Subsec. (b). Pub. L. 99–272, § 17004(3), substituted
‘‘States in which grants under such subsection have not
been made’’ for ‘‘other States’’.
Subsecs. (c), (d). Pub. L. 99–272, § 17004(4), (5), added
subsec. (c) and redesignated former subsec. (c) as (d).

§ 300w–10. Repealed. Pub. L. 106–386, div. B, title
IV, § 1401(b), Oct. 28, 2000, 114 Stat. 1513
Section, act July 1, 1944, ch. 373, title XIX, § 1910A, as
added Pub. L. 103–322, title IV, § 40151, Sept. 13, 1994, 108
Stat. 1920, related to use of allotments for rape prevention education. See section 280b–1b of this title.
A prior section 300w–10, act July 1, 1944, ch. 373, title
XIX, § 1910A, as added Oct. 30, 1984, Pub. L. 98–555, § 8, 98
Stat. 2856, related to State planning grants, prior to repeal by Pub. L. 100–607, title III, § 303, Nov. 4, 1988, 102
Stat. 3112.

PART B—BLOCK GRANTS REGARDING MENTAL
HEALTH AND SUBSTANCE ABUSE
SUBPART I—BLOCK GRANTS FOR COMMUNITY
MENTAL HEALTH SERVICES

§ 300x. Formula grants to States
(a) In general
For the purpose described in subsection (b) of
this section, the Secretary, acting through the
Director of the Center for Mental Health Services, shall make an allotment each fiscal year
for each State in an amount determined in accordance with section 300x–7 of this title. The
Secretary shall make a grant to the State of the
allotment made for the State for the fiscal year
if the State submits to the Secretary an application in accordance with section 300x–6 of this
title.
(b) Purpose of grants
A funding agreement for a grant under subsection (a) of this section is that, subject to section 300x–5 of this title, the State involved will
expend the grant only for the purpose of—
(1) carrying out the plan submitted under
section 300x–1(a) of this title by the State for
the fiscal year involved;

Page 1101

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) evaluating programs and services carried
out under the plan; and
(3) planning, administration, and educational activities related to providing services under the plan.
(July 1, 1944, ch. 373, title XIX, § 1911, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 378.)
PRIOR PROVISIONS
A prior section 300x, act July 1, 1944, ch. 373, title
XIX, § 1911, as added Aug. 13, 1981, Pub. L. 97–35, title IX,
§ 901, 95 Stat. 543; amended Oct. 19, 1984, Pub. L. 98–509,
title I, §§ 101, 106(a), 98 Stat. 2353, 2358; Nov. 18, 1988,
Pub. L. 100–690, title II, § 2021, 102 Stat. 4194, authorized
appropriations in fiscal years 1990 and 1991 for purpose
of carrying out this subpart and section 290aa–11 of this
title, prior to repeal by Pub. L. 102–321, § 201(2).
EFFECTIVE DATE
Part effective July 10, 1992, with programs making
awards providing financial assistance in fiscal year 1993
and subsequent years effective for awards made on or
after Oct. 1, 1992, and with provision that section 205(a)
of Pub. L. 102–321, set out below, regarding allotments
made for fiscal year 1992 under this part as in effect on
the day before July 10, 1992, applies with respect to the
program established in this part, see section 801(b), (d)
of Pub. L. 102–321, set out as an Effective Date of 1992
Amendment note under section 236 of this title.
TEMPORARY PROVISIONS REGARDING FUNDING
Section 205 of Pub. L. 102–321, as amended by Pub. L.
102–352, § 2(c), Aug. 26, 1992, 106 Stat. 939; Pub. L. 102–408,
title III, § 312, Oct. 13, 1992, 106 Stat. 2091, provided that,
with respect to allotments made for fiscal year 1992
under this part, as in effect on the day before July 10,
1992, any portion of the total of such allotments that
has not been paid to the States as of the first day of the
fourth quarter of such fiscal year be reallotted with the
result that the total allotment made for a State for fiscal year 1992 be the amount indicated for the State in
a specified table, authorized Secretary of Health and
Human Services to make a grant to a State of the reallotment if the State agrees that the grant be subject to
all conditions upon which allotments and payments
under this part, as in effect on the day before July 10,
1992, are made for fiscal 1992, with specified exceptions,
permitted transfers of allotments made in fiscal years
1993 and 1994 between this part and subpart II, section
300x–21 of this title, under certain circumstances, defined terms as used, and directed funding, subject to a
limitation, of a program for pregnant and postpartum
women for fiscal year 1993.
REPORT ON ALLOTMENT FORMULA
Section 707 of Pub. L. 102–321 directed Secretary of
Health and Human Services to enter into a contract
with National Academy of Sciences, or if such Academy
declines, with another public or nonprofit private agency, for purpose of conducting a study or studies concerning statutory formulae under which funds made
available under this section and section 300x–21 of this
title are allocated among States and territories, specified findings to be made by the study or studies, directed Secretary to ensure that not later than 6 months
after July 10, 1992, the study was completed and a report submitted to Committee on Energy and Commerce
of House of Representatives and Committee on Labor
and Human Resources of Senate, and directed entity
preparing the report to consult with Comptroller General with Comptroller General to review the study after
its submittal and within three months make appropriate recommendations concerning such report to such
committees.

§ 300x–1

§ 300x–1. State plan for comprehensive community mental health services for certain individuals
(a) In general
The Secretary may make a grant under section 300x of this title only if—
(1) the State involved submits to the Secretary a plan for providing comprehensive
community mental health services to adults
with a serious mental illness and to children
with a serious emotional disturbance;
(2) the plan meets the criteria specified in
subsection (b) of this section; and
(3) the plan is approved by the Secretary.
(b) Criteria for plan
With respect to the provision of comprehensive community mental health services to individuals who are either adults with a serious
mental illness or children with a serious emotional disturbance, the criteria referred to in
subsection (a) of this section regarding a plan
are as follows:
(1) Comprehensive community-based mental
health systems
The plan provides for an organized community-based system of care for individuals with
mental illness and describes available services
and resources in a comprehensive system of
care, including services for dually diagnosed
individuals. The description of the system of
care shall include health and mental health
services, rehabilitation services, employment
services, housing services, educational services, substance abuse services, medical and
dental care, and other support services to be
provided to individuals with Federal, State
and local public and private resources to enable such individuals to function outside of inpatient or residential institutions to the maximum extent of their capabilities, including
services to be provided by local school systems
under the Individuals with Disabilities Education Act [20 U.S.C. 1400 et seq.]. The plan
shall include a separate description of case
management services and provide for activities leading to reduction of hospitalization.
(2) Mental health system data and epidemiology
The plan contains an estimate of the incidence and prevalence in the State of serious
mental illness among adults and serious emotional disturbance among children and presents quantitative targets to be achieved in
the implementation of the system described in
paragraph (1).
(3) Children’s services
In the case of children with serious emotional disturbance, the plan—
(A) subject to subparagraph (B), provides
for a system of integrated social services,
educational services, juvenile services, and
substance abuse services that, together with
health and mental health services, will be
provided in order for such children to receive
care appropriate for their multiple needs
(such system to include services provided
under the Individuals with Disabilities Education Act [20 U.S.C. 1400 et seq.]);

§ 300x–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) provides that the grant under section
300x of this title for the fiscal year involved
will not be expended to provide any service
under such system other than comprehensive community mental health services; and
(C) provides for the establishment of a defined geographic area for the provision of
the services of such system.
(4) Targeted services to rural and homeless
populations
The plan describes the State’s outreach to
and services for individuals who are homeless
and how community-based services will be
provided to individuals residing in rural areas.
(5) Management systems
The plan describes the financial resources,
staffing and training for mental health providers that is necessary to implement the plan,
and provides for the training of providers of
emergency health services regarding mental
health. The plan further describes the manner
in which the State intends to expend the grant
under section 300x of this title for the fiscal
year involved.
Except as provided for in paragraph (3), the
State plan shall contain the information required under this subsection with respect to
both adults with serious mental illness and children with serious emotional disturbance.
(c) Definitions regarding mental illness and emotional disturbance; methods for estimate of
incidence and prevalence
(1) Establishment by Secretary of definitions;
dissemination
For purposes of this subpart, the Secretary
shall establish definitions for the terms
‘‘adults with a serious mental illness’’ and
‘‘children with a serious emotional disturbance’’. The Secretary shall disseminate the
definitions to the States.
(2) Standardized methods
The Secretary shall establish standardized
methods for making the estimates required in
subsection (b)(11) 1 of this section with respect
to a State. A funding agreement for a grant
under section 300x of this title for the State is
that the State will utilize such methods in
making the estimates.
(3) Date certain for compliance by Secretary
Not later than 90 days after July 10, 1992, the
Secretary shall establish the definitions described in paragraph (1), shall begin dissemination of the definitions to the States, and shall
establish the standardized methods described
in paragraph (2).
(d) Requirement of implementation of plan
(1) Complete implementation
Except as provided in paragraph (2), in making a grant under section 300x of this title to
a State for a fiscal year, the Secretary shall
make a determination of the extent to which
the State has implemented the plan required
in subsection (a) of this section. If the Secretary determines that a State has not com1 See

References in Text note below.

Page 1102

pletely implemented the plan, the Secretary
shall reduce the amount of the allotment
under section 300x of this title for the State
for the fiscal year involved by an amount
equal to 10 percent of the amount determined
under section 300x–7 of this title for the State
for the fiscal year.
(2) Substantial implementation and good faith
effort regarding fiscal year 1993
(A) In making a grant under section 300x of
this title to a State for fiscal year 1993, the
Secretary shall make a determination of the
extent to which the State has implemented
the plan required in subsection (a) of this section. If the Secretary determines that the
State has not substantially implemented the
plan, the Secretary shall, subject to subparagraph (B), reduce the amount of the allotment
under section 300x of this title for the State
for such fiscal year by an amount equal to 10
percent of the amount determined under section 300x–7 of this title for the State for the
fiscal year.
(B) In carrying out subparagraph (A), if the
Secretary determines that the State is making a good faith effort to implement the plan
required in subsection (a) of this section, the
Secretary may make a reduction under such
subparagraph in an amount that is less than
the amount specified in such subparagraph,
except that the reduction may not be made in
an amount that is less than 5 percent of the
amount determined under section 300x–7 of
this title for the State for fiscal year 1993.
(July 1, 1944, ch. 373, title XIX, § 1912, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 379; amended Pub. L. 106–310, div. B, title
XXXII, § 3204(a), Oct. 17, 2000, 114 Stat. 1192.)
REFERENCES IN TEXT
The Individuals with Disabilities Education Act, referred to in subsec. (b)(1), (3)(A), is title VI of Pub. L.
91–230, Apr. 13, 1970, 84 Stat. 175, as amended, which is
classified generally to chapter 33 (§ 1400 et seq.) of Title
20, Education. For complete classification of this Act
to the Code, see section 1400 of Title 20 and Tables.
Subsection (b)(11) of this section, referred to in subsec. (c)(2), was repealed by Pub. L. 106–310, div. B, title
XXXII, § 3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions
relating to estimates formerly contained in subsec.
(b)(11) are now contained in subsec. (b)(2) of this section.
PRIOR PROVISIONS
Prior sections 300x–1 to 300x–1b were repealed by Pub.
L. 102–321, title II, § 201(2), July 10, 1992, 106 Stat. 378.
Section 300x–1, act July 1, 1944, ch. 373, title XIX,
§ 1912, as added Oct. 19, 1984, Pub. L. 98–509, title I,
§ 102(a), 98 Stat. 2353, authorized grants for training of
employees adversely affected by changes in delivery of
mental health services and for providing assistance in
securing employment.
Another prior section 300x–1, act July 1, 1944, ch. 373,
title XIX, § 1912, as added Aug. 13, 1981, Pub. L. 97–35,
title IX, § 901, 95 Stat. 543; amended Jan. 4, 1983, Pub. L.
97–414, § 8(t), 96 Stat. 2062; Oct. 19, 1984, Pub. L. 98–509,
title I, § 106(e), 98 Stat. 2358, contained provisions relating to grants and allotment of grants for alcohol, drug
abuse, and mental health services, prior to repeal by
section 102(a) of Pub. L. 98–509.
Section 300x–1a, act July 1, 1944, ch. 373, title XIX,
§ 1912A, as added and amended Nov. 18, 1988, Pub. L.
100–690, title II, §§ 2022(a)–(c), 2023, 102 Stat. 4194, 4196,

Page 1103

TITLE 42—THE PUBLIC HEALTH AND WELFARE

4197; Aug. 16, 1989, Pub. L. 101–93, § 2(a), 103 Stat. 603, related to allotments of grants for alcohol, drug abuse,
and mental health services.
Another prior section 300x–1a, act July 1, 1944, ch. 373,
title XIX, § 1913, as added Oct. 19, 1984, Pub. L. 98–509,
title I, § 102(a), 98 Stat. 2353, was transferred to section
300x–1b of this title.
Section 300x–1b, act July 1, 1944, ch. 373, title XIX,
§ 1913, as added Oct. 19, 1984, Pub. L. 98–509, title I,
§ 102(a), 98 Stat. 2353; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2022(d), 102 Stat. 4197; Aug. 16, 1989,
Pub. L. 101–93, § 2(b), 103 Stat. 605, related to allotments
to States and Indian tribes or tribal organizations for
alcohol, drug abuse, and mental health services.
AMENDMENTS
2000—Subsec. (b). Pub. L. 106–310 added pars. (1) to (5)
and concluding provisions and struck out former pars.
(1) to (12) relating to criteria for plan.

§ 300x–2. Certain agreements
(a) Allocation for systems of integrated services
for children
(1) In general
With respect to children with a serious emotional disturbance, a funding agreement for a
grant under section 300x of this title is that—
(A) in the case of a grant for fiscal year
1993, the State involved will expend not less
than 10 percent of the grant to increase (relative to fiscal year 1992) funding for the system of integrated services described in section 300x–1(b)(9) 1 of this title;
(B) in the case of a grant for fiscal year
1994, the State will expend not less than 10
percent of the grant to increase (relative to
fiscal year 1993) funding for such system; and
(C) in the case of a grant for any subsequent fiscal year, the State will expend for
such system not less than an amount equal
to the amount expended by the State for fiscal year 1994.
(2) Waiver
(A) Upon the request of a State, the Secretary may provide to the State a waiver of all
or part of the requirement established in paragraph (1) if the Secretary determines that the
State is providing an adequate level of comprehensive community mental health services
for children with a serious emotional
distrubance,2 as indicated by a comparison of
the number of such children for which such
services are sought with the availability in
the State of the services.
(B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not
later than 120 days after the date on which the
request is made.
(C) Any waiver provided by the Secretary
under subparagraph (A) shall be applicable
only to the fiscal year involved.
(b) Providers of services
A funding agreement for a grant under section
300x of this title for a State is that, with respect
to the plan submitted under section 300x–1(a) of
this title for the fiscal year involved—
(1) services under the plan will be provided
only through appropriate, qualified commu1 See
2 So

References in Text note below.
in original. Probably should be ‘‘disturbance,’’.

§ 300x–2

nity programs (which may include community
mental health centers, child mental-health
programs, psychosocial rehabilitation programs, mental health peer-support programs,
and mental-health primary consumer-directed
programs); and
(2) services under the plan will be provided
through community mental health centers
only if the centers meet the criteria specified
in subsection (c) of this section.
(c) Criteria for mental health centers
The criteria referred to in subsection (b)(2) of
this section regarding community mental health
centers are as follows:
(1) With respect to mental health services,
the centers provide services as follows:
(A) Services principally to individuals residing in a defined geographic area (hereafter in this subsection referred to as a
‘‘service area’’).
(B) Outpatient services, including specialized outpatient services for children, the elderly, individuals with a serious mental illness, and residents of the service areas of the
centers who have been discharged from inpatient treatment at a mental health facility.
(C) 24-hour-a-day emergency care services.
(D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services.
(E) Screening for patients being considered
for admission to State mental health facilities to determine the appropriateness of
such admission.
(2) The mental health services of the centers
are provided, within the limits of the capacities of the centers, to any individual residing
or employed in the service area of the center
regardless of ability to pay for such services.
(3) The mental health services of the centers
are available and accessible promptly, as appropriate and in a manner which preserves
human dignity and assures continuity and
high quality care.
(July 1, 1944, ch. 373, title XIX, § 1913, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 381.)
REFERENCES IN TEXT
Section 300x–1(b)(9) of this title, referred to in subsec.
(a)(1)(A), was repealed by Pub. L. 106–310, div. B, title
XXXII, § 3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions
relating to a system of integrated social services formerly contained in section 300x–1(b)(9) are now contained in section 300x–1(b)(3) of this title.
PRIOR PROVISIONS
A prior section 300x–2, act July 1, 1944, ch. 373, title
XIX, § 1914, formerly § 1913, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 545; renumbered § 1914
and amended Oct. 19, 1984, Pub. L. 98–509, title I, § 106(a),
(c)–(e), (g), 98 Stat. 2358, 2359; Nov. 18, 1988, Pub. L.
100–690, title II, § 2022(e), 102 Stat. 4197; Aug. 16, 1989,
Pub. L. 101–93, § 2(c)(1), 103 Stat. 605, related to payment
to States of allotments of grants for alcohol, drug
abuse, and mental health services, prior to repeal by
Pub. L. 102–321, § 201(2).
A prior section 1913 of act July 1, 1944, was classified
to section 300x–1b of this title and repealed by Pub. L.
102–321.

§ 300x–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300x–3. State mental health planning council
(a) In general
A funding agreement for a grant under section
300x of this title is that the State involved will
establish and maintain a State mental health
planning council in accordance with the conditions described in this section.
(b) Duties
A condition under subsection (a) of this section for a Council is that the duties of the Council are—
(1) to review plans provided to the Council
pursuant to section 300x–4(a) of this title by
the State involved and to submit to the State
any recommendations of the Council for modifications to the plans;
(2) to serve as an advocate for adults with a
serious mental illness, children with a severe
emotional disturbance, and other individuals
with mental illnesses or emotional problems;
and
(3) to monitor, review, and evaluate, not less
than once each year, the allocation and adequacy of mental health services within the
State.
(c) Membership
(1) In general
A condition under subsection (a) of this section for a Council is that the Council be composed of residents of the State, including representatives of—
(A) the principal State agencies with respect to—
(i) mental health, education, vocational
rehabilitation, criminal justice, housing,
and social services; and
(ii) the development of the plan submitted pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.];
(B) public and private entities concerned
with the need, planning, operation, funding,
and use of mental health services and related support services;
(C) adults with serious mental illnesses
who are receiving (or have received) mental
health services; and
(D) the families of such adults or families
of children with emotional disturbance.
(2) Certain requirements
A condition under subsection (a) of this section for a Council is that—
(A) with respect to the membership of the
Council, the ratio of parents of children with
a serious emotional disturbance to other
members of the Council is sufficient to provide adequate representation of such children in the deliberations of the Council; and
(B) not less than 50 percent of the members
of the Council are individuals who are not
State employees or providers of mental
health services.
(d) ‘‘Council’’ defined
For purposes of this section, the term ‘‘Council’’ means a State mental health planning
council.
(July 1, 1944, ch. 373, title XIX, § 1914, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 382.)

Page 1104

REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(c)(1)(A)(ii), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Act is classified generally to
subchapter XIX (§ 1396 et seq.) of chapter 7 of this title.
For complete classification of this Act to the Code, see
section 1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 300x–3, act July 1, 1944, ch. 373, title
XIX, § 1915, formerly § 1914, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 545; renumbered § 1915
and amended Oct. 19, 1984, Pub. L. 98–509, title I,
§§ 105(b), 106(a), (b), (d), (g), 98 Stat. 2358, 2359; Nov. 18,
1988, Pub. L. 100–690, title II, §§ 2024–2026, 102 Stat. 4198,
4199; Aug. 16, 1989, Pub. L. 101–93, § 2(d), 103 Stat. 606;
Nov. 28, 1990, Pub. L. 101–639, § 3(a)(2), 104 Stat. 4601, related to the use of grant allotments for alcohol, drug
abuse, and mental health services, prior to repeal by
Pub. L. 102–321, § 201(2).
A prior section 1914 of act July 1, 1944, was classified
to section 300x–2 of this title prior to repeal by Pub. L.
102–321.

§ 300x–4. Additional provisions
(a) Review of State plan by mental health planning council
The Secretary may make a grant under section 300x of this title to a State only if—
(1) the plan submitted under section
300x–1(a) of this title with respect to the grant
and the report of the State under section
300x–52(a) of this title concerning the preceding fiscal year has been reviewed by the State
mental health planning council under section
300x–3 of this title; and
(2) the State submits to the Secretary any
recommendations received by the State from
such council for modifications to the plan
(without regard to whether the State has
made the recommended modifications) and
any comments concerning the annual report.
(b) Maintenance of effort regarding State expenditures for mental health
(1) In general
A funding agreement for a grant under section 300x of this title is that the State involved will maintain State expenditures for
community mental health services at a level
that is not less than the average level of such
expenditures maintained by the State for the
2-year period preceding the fiscal year for
which the State is applying for the grant.
(2) Exclusion of certain funds
The Secretary may exclude from the aggregate State expenditures under subsection (a)
of this section, funds appropriated to the principle agency for authorized activities which
are of a non-recurring nature and for a specific
purpose.
(3) Waiver
The Secretary may, upon the request of a
State, waive the requirement established in
paragraph (1) if the Secretary determines that
extraordinary economic conditions in the
State justify the waiver.
(4) Noncompliance by State
(A) In making a grant under section 300x of
this title to a State for a fiscal year, the Sec-

Page 1105

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300x–6

retary shall make a determination of whether,
for the previous fiscal year, the State maintained material compliance with the agreement made under paragraph (1). If the Secretary determines that a State has failed to
maintain such compliance, the Secretary shall
reduce the amount of the allotment under section 300x of this title for the State for the fiscal year for which the grant is being made by
an amount equal to the amount constituting
such failure for the previous fiscal year.
(B) The Secretary may make a grant under
section 300x of this title for a fiscal year only
if the State involved submits to the Secretary
information sufficient for the Secretary to
make the determination required in subparagraph (A).

(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition
for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private
entity.
(b) Limitation on administrative expenses
A funding agreement for a grant under section
300x of this title is that the State involved will
not expend more than 5 percent of the grant for
administrative expenses with respect to the
grant.

(July 1, 1944, ch. 373, title XIX, § 1915, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 383; amended Pub. L. 106–310, div. B, title
XXXII, § 3204(b), (c), Oct. 17, 2000, 114 Stat. 1193.)

A prior section 300x–5, act July 1, 1944, ch. 373, title
XIX, § 1917, formerly § 1916, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 549; renumbered § 1917
and amended Oct. 19, 1984, Pub. L. 98–509, title I, §§ 104,
106(a), (b), (d), (g), 98 Stat. 2357–2359; Oct. 7, 1985, Pub.
L. 99–117, § 7(b), 99 Stat. 493; Nov. 18, 1988, Pub. L.
100–690, title II, §§ 2037(a)(1), (b), 2052(b), 102 Stat. 4203,
4208; Aug. 16, 1989, Pub. L. 101–93, § 2(p)(2), 103 Stat. 609,
related to reports and audits relative to grants for alcohol, drug abuse, and mental health services, prior to repeal by Pub. L. 102–321, § 201(2).
A prior section 1916 of act July 1, 1944, was classified
to section 300x–4 of this title prior to repeal by Pub. L.
102–321.

PRIOR PROVISIONS
Prior sections 300x–4 and 300x–4a were repealed by
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106 Stat.
378.
Section 300x–4, act July 1, 1944, ch. 373, title XIX,
§ 1916, formerly § 1915, as added Aug. 13, 1981, Pub. L.
97–35, title IX, § 901, 95 Stat. 546; amended Jan. 4, 1983,
Pub. L. 97–414, § 8(u), 96 Stat. 2063; renumbered § 1916 and
amended Oct. 19, 1984, Pub. L. 98–509, title I, §§ 103,
106(a)–(c), (f), (g), 98 Stat. 2355, 2358, 2359; Oct. 7, 1985,
Pub. L. 99–117, § 7(a), 99 Stat. 492; Nov. 14, 1986, Pub. L.
99–660, title V, § 503, 100 Stat. 3797; Nov. 18, 1988, Pub. L.
100–690, title II, §§ 2027–2035, 2037(a)(2), 102 Stat.
4199–4201, 4203; Aug. 16, 1989, Pub. L. 101–93, § 2(e)–(l),
(p)(1), (q)(1), 103 Stat. 606–609; Aug. 15, 1990, Pub. L.
101–374, § 4(b), 104 Stat. 459, required States to make application and describe their activities in relation to allotments for grants for alcohol, drug abuse, and mental
health services.
A prior section 1915 of act July 1, 1944, was classified
to section 300x–3 of this title prior to repeal by Pub. L.
102–321.
Section 300x–4a, act July 1, 1944, ch. 373, title XIX,
§ 1916A, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2036, 102 Stat. 4202; amended Aug. 16, 1989, Pub. L.
101–93, § 2(m), 103 Stat. 608, related to group homes for
recovering substance abusers.
AMENDMENTS
2000—Subsec. (a)(1). Pub. L. 106–310, § 3204(b)(1), inserted ‘‘and the report of the State under section
300x–52(a) of this title concerning the preceding fiscal
year’’ after ‘‘to the grant’’.
Subsec. (a)(2). Pub. L. 106–310, § 3204(b)(2), inserted
‘‘and any comments concerning the annual report’’ before period at end.
Subsec. (b)(2) to (4). Pub. L. 106–310, § 3204(c), added
par. (2) and redesignated former pars. (2) and (3) as (3)
and (4), respectively.

§ 300x–5. Restrictions on use of payments
(a) In general
A funding agreement for a grant under section
300x of this title is that the State involved will
not expend the grant—
(1) to provide inpatient services;
(2) to make cash payments to intended recipients of health services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other
than minor remodeling) any building or other
facility, or purchase major medical equipment;

(July 1, 1944, ch. 373, title XIX, § 1916, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 384.)
PRIOR PROVISIONS

§ 300x–6. Application for grant
(a) In general
For purposes of section 300x of this title, an
application for a grant under such section for a
fiscal year in accordance with this section if,
subject to subsection (b) of this section—
(1) the plan is received by the Secretary not
later than September 1 of the fiscal year prior
to the fiscal year for which a State is seeking
funds, and the report from the previous fiscal
year as required under section 300x–51 of this
title is received by December 1 of the fiscal
year of the grant;
(2) the application contains each funding
agreement that is described in this subpart or
subpart III for such a grant (other than any
such agreement that is not applicable to the
State);
(3) the agreements are made through certification from the chief executive officer of the
State;
(4) with respect to such agreements, the application provides assurances of compliance
satisfactory to the Secretary;
(5) the application contains the plan required in section 300x–1(a) of this title, the information required in section 300x–4(b)(3)(B) 1
of this title, and the report required in section
300x–52(a) of this title;
(6) the application contains recommendations in compliance with section 300x–4(a) of
this title, or if no such recommendations are
received by the State, the application otherwise demonstrates compliance with such section; and
(7) the application (including the plan under
section 300x–1(a) of this title) is otherwise in
1 See

References in Text note below.

§ 300x–7

TITLE 42—THE PUBLIC HEALTH AND WELFARE

such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subpart.
(b) Waivers regarding certain territories
In the case of any territory of the United
States except Puerto Rico, the Secretary may
waive such provisions of this subpart and subpart III as the Secretary determines to be appropriate, other than the provisions of section
300x–5 of this title.
(July 1, 1944, ch. 373, title XIX, § 1917, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 384; amended Pub. L. 106–310, div. B, title
XXXII, § 3204(d), (e), Oct. 17, 2000, 114 Stat. 1193.)
REFERENCES IN TEXT
Section 300x–4(b)(3)(B) of this title, referred to in subsec. (a)(5), was redesignated section 300x–4(b)(4)(B) by
Pub. L. 106–310, div. B, title XXXII, § 3204(c)(1), Oct. 17,
2000, 114 Stat. 1193.
PRIOR PROVISIONS
A prior section 300x–6, act July 1, 1944, ch. 373, title
XIX, § 1918, formerly § 1917, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 550; renumbered § 1918
and amended Oct. 19, 1984, Pub. L. 98–509, title I, § 106(d),
(g), 98 Stat. 2358, 2359, authorized withholding funds
from States which did not use allotments of grants for
alcohol, drug abuse, and mental health services in accordance with requirements, prior to repeal by Pub. L.
102–321, § 201(2).
A prior section 1917 of act July 1, 1944, was classified
to section 300x–5 of this title prior to repeal by Pub. L.
102–321.
AMENDMENTS
2000—Subsec. (a)(1). Pub. L. 106–310, § 3204(d), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘the State involved submits the application
not later than the date specified by the Secretary as
being the date after which applications for such a grant
will not be considered (in any case in which the Secretary specifies such a date);’’.
Subsec. (b). Pub. L. 106–310, § 3204(e), substituted ‘‘except Puerto Rico’’ for ‘‘whose allotment under section
300x of this title for the fiscal year is the amount specified in section 300x–7(c)(2)(B) of this title’’.

§ 300x–7. Determination of amount of allotment
(a) States
(1) Determination under formula
Subject to subsection (b) of this section, the
Secretary shall determine the amount of the
allotment required in section 300x of this title
for a State for a fiscal year in accordance with
the following formula:
A +

X
U

,

(2) Determination of term ‘‘A’’
For purposes of paragraph (1), the term ‘‘A’’
means the difference between—
(A) the amount appropriated under section
300x–9(a) of this title for allotments under
section 300x of this title for the fiscal year
involved; and
(B) an amount equal to 1.5 percent of the
amount referred to in subparagraph (A).
(3) Determination of term ‘‘U’’
For purposes of paragraph (1), the term ‘‘U’’
means the sum of the respective terms ‘‘X’’ determined for the States under paragraph (4).

Page 1106

(4) Determination of term ‘‘X’’
For purposes of paragraph (1), the term ‘‘X’’
means the product of—
(A) an amount equal to the product of—
(i) the term ‘‘P’’, as determined for the
State involved under paragraph (5); and
(ii) the factor determined under paragraph (8) for the State; and
(B) the greater of—
(i) 0.4; and
(ii) an amount equal to an amount determined for the State in accordance with the
following formula:
1¥.35 +

R%
P%

,

(5) Determination of term ‘‘P’’
(A) For purposes of paragraph (4), the term
‘‘P’’ means the sum of—
(i) an amount equal to the product of 0.107
and the number of individuals in the State
who are between 18 and 24 years of age (inclusive);
(ii) an amount equal to the product of 0.166
and the number of individuals in the State
who are between 25 and 44 years of age (inclusive);
(iii) an amount equal to the product of
0.099 and the number of individuals in the
State who are between 45 and 64 years of age
(inclusive); and
(iv) an amount equal to the product of
0.082 and the number of individuals in the
State who are 65 years of age or older.
(B) With respect to data on population that
is necessary for purposes of making a determination under subparagraph (A), the Secretary shall use the most recent data that is
available from the Secretary of Commerce
pursuant to the decennial census and pursuant
to reasonable estimates by such Secretary of
changes occurring in the data in the ensuing
period.
(6) Determination of term ‘‘R%’’
(A) For purposes of paragraph (4), the term
‘‘R%’’, except as provided in subparagraph (D),
means the percentage constituted by the ratio
of the amount determined under subparagraph
(B) for the State involved to the amount determined under subparagraph (C).
(B) The amount determined under this subparagraph for the State involved is the
quotient of—
(i) the most recent 3-year arithmetic mean
of the total taxable resources of the State,
as determined by the Secretary of the Treasury; divided by
(ii) the factor determined under paragraph
(8) for the State.
(C) The amount determined under this subparagraph is the sum of the respective
amounts determined for the States under subparagraph (B) (including the District of Columbia).
(D)(i) In the case of the District of Columbia,
for purposes of paragraph (4), the term ‘‘R%’’
means the percentage constituted by the ratio

Page 1107

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of the amount determined under clause (ii) for
such District to the amount determined under
clause (iii).
(ii) The amount determined under this
clause for the District of Columbia is the
quotient of—
(I) the most recent 3-year arithmetic mean
of total personal income in such District, as
determined by the Secretary of Commerce;
divided by
(II) the factor determined under paragraph
(8) for the District.
(iii) The amount determined under this
clause is the sum of the respective amounts
determined for the States (including the District of Columbia) by making, for each State,
the same determination as is described in
clause (ii) for the District of Columbia.
(7) Determination of term ‘‘P%’’
For purposes of paragraph (4), the term
‘‘P%’’ means the percentage constituted by
the ratio of the term ‘‘P’’ determined under
paragraph (5) for the State involved to the
sum of the respective terms ‘‘P’’ determined
for the States.
(8) Determination of certain factor
(A) The factor determined under this paragraph for the State involved is a factor whose
purpose is to adjust the amount determined
under clause (i) of paragraph (4)(A), and the
amounts determined under each of subparagraphs (B)(i) and (D)(ii)(I) of paragraph (6), to
reflect the differences that exist between the
State and other States in the costs of providing comprehensive community mental health
services to adults with a serious mental illness
and to children with a serious emotional disturbance.
(B) Subject to subparagraph (C), the factor
determined under this paragraph and in effect
for the fiscal year involved shall be determined according to the methodology described
in the report entitled ‘‘Adjusting the Alcohol,
Drug Abuse and Mental Health Services Block
Grant Allocations for Poverty Populations and
Cost of Service’’, dated March 30, 1990, and prepared by Health Economics Research, a corporation, pursuant to a contract with the National Institute on Drug Abuse.
(C) The factor determined under this paragraph for the State involved may not for any
fiscal year be greater than 1.1 or less than 0.9.
(D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General, shall in accordance with this section make a determination for each State of
the factor that is to be in effect for the State
under this paragraph. The factor so determined shall remain in effect through fiscal
year 1994, and shall be recalculated every third
fiscal year thereafter.
(ii) After consultation with the Comptroller
General, the Secretary shall, through publication in the Federal Register, periodically
make such refinements in the methodology referred to in subparagraph (B) as are consistent
with the purpose described in subparagraph
(A).

§ 300x–7

(b) Minimum allotments for States
With respect to fiscal year 2000, and subsequent fiscal years, the amount of the allotment
of a State under section 300x of this title shall
not be less than the amount the State received
under such section for fiscal year 1998.
(c) Territories
(1) Determination under formula
Subject to paragraphs (2) and (4), the
amount of an allotment under section 300x of
this title for a territory of the United States
for a fiscal year shall be the product of—
(A) an amount equal to the amounts reserved under paragraph (3) for the fiscal
year; and
(B) a percentage equal to the quotient of—
(i) the civilian population of the territory, as indicated by the most recently
available data; divided by
(ii) the aggregate civilian population of
the territories of the United States, as indicated by such data.
(2) Minimum allotment for territories
The amount of an allotment under section
300x of this title for a territory of the United
States for a fiscal year shall be the greater
of—
(A) the amount determined under paragraph (1) for the territory for the fiscal year;
(B) $50,000; and
(C) with respect to fiscal years 1993 and
1994, an amount equal to 20.6 percent of the
amount received by the territory from allotments made pursuant to this part for fiscal
year 1992.
(3) Reservation of amounts
The Secretary shall each fiscal year reserve
for the territories of the United States 1.5 percent of the amounts appropriated under section 300x–9(a) of this title for allotments under
section 300x of this title for the fiscal year.
(4) Availability of data on population
With respect to data on the civilian population of the territories of the United States,
if the Secretary determines for a fiscal year
that recent such data for purposes of paragraph (1)(B) do not exist regarding a territory,
the Secretary shall for such purposes estimate
the civilian population of the territory by
modifying the data on the territory to reflect
the average extent of change occurring during
the ensuing period in the population of all territories with respect to which recent such data
do exist.
(5) Applicability of certain provisions
For purposes of subsection (a) of this section, the term ‘‘State’’ does not include the
territories of the United States.
(July 1, 1944, ch. 373, title XIX, § 1918, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 385; amended Pub. L. 102–352, § 2(a)(8), (9),
Aug. 26, 1992, 106 Stat. 938; Pub. L. 105–277, div.
A, § 101(f) [title II, § 218(a)], Oct. 21, 1998, 112 Stat.
2681–337, 2681–362; Pub. L. 106–113, div. B,
§ 1000(a)(4) [title II, § 212(a)], Nov. 29, 1999, 113
Stat. 1535, 1501A–239; Pub. L. 106–310, div. B, title
XXXII, § 3205, Oct. 17, 2000, 114 Stat. 1193.)

§ 300x–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 300x–7, act July 1, 1944, ch. 373, title
XIX, § 1919, formerly § 1918, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 551; renumbered § 1919
and amended Oct. 19, 1984, Pub. L. 98–509, title I, § 106(a),
(g), 98 Stat. 2358, 2359, related to nondiscrimination provisions with respect to alcohol, drug abuse, and mental
health programs, prior to repeal by Pub. L. 102–321,
§ 201(2).
A prior section 1918 of act July 1, 1944, was classified
to section 300x–6 of this title prior to repeal by Pub. L.
102–321.
AMENDMENTS
2000—Subsec. (b). Pub. L. 106–310 reenacted heading
without change and amended text generally. Prior to
amendment, text read as follows: ‘‘With respect to fiscal year 2000, the amount of the allotment of a State
under section 300x of this title shall not be less than
the amount the State received under section 300x of
this title for fiscal year 1998.’’
1999—Subsec. (b). Pub. L. 106–113 amended heading
and text of subsec. (b) generally. Prior to amendment,
text read as follows: ‘‘For each of the fiscal years 1993
and 1994, the amount of the allotment required in section 300x of this title for a State for the fiscal year involved shall be the greater of—
‘‘(1) the amount determined under subsection (a) of
this section for the State for the fiscal year; and
‘‘(2) an amount equal to 20.6 percent of the amount
received by the State from allotments made pursuant
to this part for fiscal year 1992 (including reallotments under section 205(a) of the ADAMHA Reorganization Act).’’
1998—Subsec. (b). Pub. L. 105–277, temporarily amended subsec. (b) to read as follows: ‘‘(b) MINIMUM ALLOTMENTS FOR STATES.—
‘‘(1) IN GENERAL.—With respect to fiscal year 1999,
the amount of the allotment of a State under section
300x of this title shall not be less than the amount
the State received under section 300x of this title for
fiscal year 1998.’’
See Effective and Termination Dates of 1998 Amendment note below.
1992—Subsec. (a)(5)(A)(iii). Pub. L. 102–352, § 2(a)(8),
substituted ‘‘45’’ for ‘‘25’’.
Subsec. (c)(2)(C). Pub. L. 102–352, § 2(a)(9), added subpar. (C).
EFFECTIVE AND TERMINATION DATES OF 1998
AMENDMENT
Pub. L. 105–277, div. A, § 101(f) [title II, § 218(c)], Oct.
21, 1998, 112 Stat. 2681–337, 2681–363, provided that:
‘‘(1) IN GENERAL.—The amendments made by subsections (a) and (b) [amending this section and section
300x–33 of this title] shall become effective as if enacted
on October 1, 1998 and shall only apply during fiscal
year 1999.
‘‘(2) APPLICATION.—Upon the expiration of the fiscal
year described in paragraph (1), the provisions of sections 1918(b) and 1933(b) of the Public Health Service
Act (42 U.S.C. 300x–7(b) and 300x–33(b)), as in effect on
September 30, 1998, shall be applied as if the amendments made by this section had not been enacted.’’
EFFECTIVE DATE OF 1992 AMENDMENTS
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.

§ 300x–8. Definitions
For purposes of this subpart:
(1) The terms ‘‘adults with a serious mental
illness’’ and ‘‘children with a serious emotional disturbance’’ have the meanings given
such terms under section 300x–1(c)(1) of this
title.

Page 1108

(2) The term ‘‘funding agreement’’, with respect to a grant under section 300x of this title
to a State, means that the Secretary may
make such a grant only if the State makes the
agreement involved.
(July 1, 1944, ch. 373, title XIX, § 1919, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 388.)
PRIOR PROVISIONS
A prior section 300x–8, act July 1, 1944, ch. 373, title
XIX, § 1920, formerly § 1919, as added Aug. 13, 1981, Pub.
L. 97–35, title IX, § 901, 95 Stat. 552; renumbered § 1920,
Oct. 19, 1984, Pub. L. 98–509, title I, § 106(g), 98 Stat. 2359,
authorized criminal penalty for false statements in
connection with services furnished relative to alcohol,
drug abuse, and mental health services block grant,
prior to repeal by Pub. L. 102–321, § 201(2).
A prior section 1919 of act July 1, 1944, was classified
to section 300x–7 of this title prior to repeal by Pub. L.
102–321.

§ 300x–9. Funding
(a) Authorization of appropriations
For the purpose of carrying out this subpart,
and subpart III and section 290aa–4 of this title
with respect to mental health, there are authorized to be appropriated $450,000,000 for fiscal year
2001, and such sums as may be necessary for
each of the fiscal years 2002 and 2003.
(b) Allocations for technical assistance, data collection, and program evaluation
(1) In general
For the purpose of carrying out section
300x–58(a) of this title with respect to mental
health and the purposes specified in paragraphs (2) and (3), the Secretary shall obligate
5 percent of the amounts appropriated under
subsection (a) of this section for a fiscal year.
(2) Data collection
The purpose specified in this paragraph is
carrying out sections 290aa–4 and 300y of this
title with respect to mental health.
(3) Program evaluation
The purpose specified in this paragraph is
the conduct of evaluations of prevention and
treatment programs and services with respect
to mental health to determine methods for improving the availability and quality of such
programs and services.
(July 1, 1944, ch. 373, title XIX, § 1920, as added
Pub. L. 102–321, title II, § 201(2), July 10, 1992, 106
Stat. 388; amended Pub. L. 106–310, div. B, title
XXXII, § 3204(f), Oct. 17, 2000, 114 Stat. 1193.)
PRIOR PROVISIONS
Prior sections 300x–9 to 300x–13 were repealed by Pub.
L. 102–321, title II, § 201(2), July 10, 1992, 106 Stat. 378.
Section 300x–9, act July 1, 1944, ch. 373, title XIX,
§ 1921, formerly § 1920, as added Aug. 13, 1981, Pub. L.
97–35, title IX, § 901, 95 Stat. 552; renumbered § 1920A and
amended Oct. 19, 1984, Pub. L. 98–509, title I, §§ 105(a),
106(g), 98 Stat. 2358, 2359; Oct. 7, 1985, Pub. L. 99–117,
§ 7(c), 99 Stat. 493; renumbered § 1921 and amended Nov.
18, 1988, Pub. L. 100–690, title II, § 2038(2), (6), 102 Stat.
4203, authorized technical assistance with respect to development of services under alcohol, drug abuse, and
mental health services block grants.
A prior section 1920 of act July 1, 1944, was classified
to section 300x–8 of this title and repealed by Pub. L.
102–321.

Page 1109

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 300x–9a, act July 1, 1944, ch. 373, title XIX,
§ 1922, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2039(a), 102 Stat. 4204; amended Aug. 16, 1989, Pub. L.
101–93, § 2(n)(1), 103 Stat. 608, related to service research
on community-based alcohol and drug abuse treatment
programs.
Section 300x–9b, act July 1, 1944, ch. 373, title XIX,
§ 1923, as added Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2040, 102 Stat. 4204; amended Aug. 16, 1989, Pub. L.
101–93, § 2(q)(2), 103 Stat. 609, related to service research
on community-based mental health treatment programs.
Section 300x–10, act July 1, 1944, ch. 373, title XIX,
§ 1924, formerly § 1920B, as added Nov. 14, 1986, Pub. L.
99–660, title V, § 502(2), 100 Stat. 3795; renumbered § 1924
and amended Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2038(3), (4), 102 Stat. 4203; Nov. 28, 1990, Pub. L. 101–639,
§ 3(a)(1), 104 Stat. 4601, related to development grants
for State comprehensive mental health services plans.
Section 300x–11, act July 1, 1944, ch. 373, title XIX,
§ 1925, formerly § 1920C, as added Nov. 14, 1986, Pub. L.
99–660, title V, § 502(2), 100 Stat. 3795; renumbered § 1925
and amended Nov. 18, 1988, Pub. L. 100–690, title II,
§§ 2038(3), 2041(a), 102 Stat. 4203, 4205; Aug. 16, 1989, Pub.
L. 101–93, § 2(o)(1), 103 Stat. 608; Nov. 28, 1990, Pub. L.
101–639, § 3(b), 104 Stat. 4601, related to State comprehensive mental health services plans.
Section 300x–12, act July 1, 1944, ch. 373, title XIX,
§ 1926, formerly § 1920D, as added Nov. 14, 1986, Pub. L.
99–660, title V, § 502(2), 100 Stat. 3796; renumbered § 1926
and amended Nov. 18, 1988, Pub. L. 100–690, title II,
§ 2038(3), (5), 102 Stat. 4203; Aug. 16, 1989, Pub. L. 101–93,
§ 2(o)(2), 103 Stat. 609; Nov. 28, 1990, Pub. L. 101–639,
§ 3(c), 104 Stat. 4602, related to enforcement of requirement of developing State comprehensive mental health
services plans.
Section 300x–13, act July 1, 1944, ch. 373, title XIX,
§ 1927, formerly § 1920E, as added Nov. 14, 1986, Pub. L.
99–660, title V, § 502(2), 100 Stat. 3797; renumbered § 1927,
Nov. 18, 1988, Pub. L. 100–690, title II, § 2038(3), 102 Stat.
4203, related to development of model standards for provision of care to chronically mentally ill persons.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, § 3204(f)(1), substituted ‘‘$450,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal years 2002
and 2003’’ for ‘‘$450,000,000 for fiscal year 1993, and such
sums as may be necessary for fiscal year 1994’’.
Subsec. (b)(2). Pub. L. 106–310, § 3204(f)(2), substituted
‘‘sections 290aa–4 and 300y of this title’’ for ‘‘section
290aa–4 of this title’’.
SUBPART II—BLOCK GRANTS FOR PREVENTION AND
TREATMENT OF SUBSTANCE ABUSE

§ 300x–21. Formula grants to States
(a) In general
For the purpose described in subsection (b) of
this section, the Secretary, acting through the
Center for Substance Abuse Treatment, shall
make an allotment each fiscal year for each
State in an amount determined in accordance
with section 300x–33 of this title. The Secretary
shall make a grant to the State of the allotment
made for the State for the fiscal year if the
State submits to the Secretary an application in
accordance with section 300x–32 of this title.
(b) Authorized activities
A funding agreement for a grant under subsection (a) of this section is that, subject to section 300x–31 of this title, the State involved will
expend the grant only for the purpose of planning, carrying out, and evaluating activities to
prevent and treat substance abuse and for relat-

§ 300x–22

ed activities authorized in section 300x–24 of this
title.
(July 1, 1944, ch. 373, title XIX, § 1921, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 388.)
PRIOR PROVISIONS
A prior section 1921 of act July 1, 1944, was classified
to section 300x–9 of this title prior to repeal by Pub. L.
102–321.
Another prior section 1921 of act July 1, 1944, was
classified to section 300y of this title prior to repeal by
Pub. L. 100–690.

§ 300x–22. Certain allocations
(a) Allocation regarding primary prevention programs
A funding agreement for a grant under section
300x–21 of this title is that, in expending the
grant, the State involved—
(1) will expend not less than 20 percent for
programs for individuals who do not require
treatment for substance abuse, which programs—
(A) educate and counsel the individuals on
such abuse; and
(B) provide for activities to reduce the risk
of such abuse by the individuals;
(2) will, in carrying out paragraph (1)—
(A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
(B) ensure that programs receiving priority under subparagraph (A) develop community-based strategies for the prevention of
such abuse, including strategies to discourage the use of alcoholic beverages and tobacco products by individuals to whom it is
unlawful to sell or distribute such beverages
or products.
(b) Allocations regarding women
(1) In general
Subject to paragraph (2), a funding agreement for a grant under section 300x–21 of this
title for a fiscal year is that—
(A) in the case of a grant for fiscal year
1993, the State involved will expend not less
than 5 percent of the grant to increase (relative to fiscal year 1992) the availability of
treatment services designed for pregnant
women and women with dependent children
(either by establishing new programs or expanding the capacity of existing programs);
(B) in the case of a grant for fiscal year
1994, the State will expend not less than 5
percent of the grant to so increase (relative
to fiscal year 1993) the availability of such
services for such women; and
(C) in the case of a grant for any subsequent fiscal year, the State will expend for
such services for such women not less than
an amount equal to the amount expended by
the State for fiscal year 1994.
(2) Waiver
(A) Upon the request of a State, the Secretary may provide to the State a waiver of all
or part of the requirement established in paragraph (1) if the Secretary determines that the

§ 300x–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State is providing an adequate level of treatments services for women described in such
paragraph, as indicated by a comparison of the
number of such women seeking the services
with the availability in the State of the services.
(B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not
later than 120 days after the date on which the
request is made.
(C) Any waiver provided by the Secretary
under subparagraph (A) shall be applicable
only to the fiscal year involved.
(3) Childcare and prenatal care
A funding agreement for a grant under section 300x–21 of this title for a State is that
each entity providing treatment services with
amounts reserved under paragraph (1) by the
State will, directly or through arrangements
with other public or nonprofit private entities,
make available prenatal care to women receiving such services and, while the women are receiving the services, childcare.
(July 1, 1944, ch. 373, title XIX, § 1922, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 389; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(a), (f)(2)(A), Oct. 17, 2000, 114 Stat.
1210, 1211.)
AMENDMENT OF SUBSECTION (b)(2), (3)
Pub. L. 106–310, div. B, title XXXIII,
§ 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that, effective upon publication of regulations developed in accordance with section
300x–32(e)(1) of this title, subsection (c) of this
section [now subsection (b)] is amended by striking out paragraph (2) and redesignating paragraph (3) as paragraph (2).
PRIOR PROVISIONS
A prior section 1922 of act July 1, 1944, was classified
to section 300x–9a of this title prior to repeal by Pub.
L. 102–321.
Another prior section 1922 of act July 1, 1944, was
classified to section 300y–1 of this title prior to repeal
by Pub. L. 100–690.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, § 3303(a), redesignated subsec. (b) as (a) and struck out heading and text
of former subsec. (a). Text read as follows: ‘‘A funding
agreement for a grant under section 300x–21 of this title
is that, in expending the grant, the State involved will
expend—
‘‘(1) not less than 35 percent for prevention and
treatment activities regarding alcohol; and
‘‘(2) not less than 35 percent for prevention and
treatment activities regarding other drugs.’’
Subsec. (b). Pub. L. 106–310, § 3303(a)(2), redesignated
subsec. (c) as (b). Former subsec. (b) redesignated (a).
Subsec. (c). Pub. L. 106–310, § 3303(a)(2), redesignated
subsec. (c) as (b).
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–310, div. B, title XXXIII, § 3303(f)(2), Oct.
17, 2000, 114 Stat. 1211, provided that the amendment
made by section 3303(f)(2) is effective upon the publication of the regulations developed in accordance with
section 300x–32(e)(1) of this title.

§ 300x–23. Intravenous substance abuse
(a) Capacity of treatment programs
(1) Notification of reaching capacity
A funding agreement for a grant under section 300x–21 of this title is that the State in-

Page 1110

volved will, in the case of programs of treatment for intravenous drug abuse, require that
any such program receiving amounts from the
grant, upon reaching 90 percent of its capacity
to admit individuals to the program, provide
to the State a notification of such fact.
(2) Provision of treatment
A funding agreement for a grant under section 300x–21 of this title is that the State involved will, with respect to notifications
under paragraph (1), ensure that each individual who requests and is in need of treatment
for intravenous drug abuse is admitted to a
program of such treatment not later than—
(A) 14 days after making the request for
admission to such a program; or
(B) 120 days after the date of such request,
if no such program has the capacity to admit
the individual on the date of such request
and if interim services are made available to
the individual not later than 48 hours after
such request.
(b) Outreach regarding intravenous substance
abuse
A funding agreement for a grant under section
300x–21 of this title is that the State involved, in
providing amounts from the grant to any entity
for treatment services for intravenous drug
abuse, will require the entity to carry out activities to encourage individuals in need of such
treatment to undergo treatment.
(July 1, 1944, ch. 373, title XIX, § 1923, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 390.)
PRIOR PROVISIONS
A prior section 1923 of act July 1, 1944, was classified
to section 300x–9b of this title prior to repeal by Pub.
L. 102–321.
Another prior section 1923 of act July 1, 1944, was
classified to section 300y–2 of this title prior to repeal
by Pub. L. 100–690.

§ 300x–24. Requirements regarding tuberculosis
and human immunodeficiency virus
(a) Tuberculosis
(1) In general
A funding agreement for a grant under section 300x–21 of this title is that the State involved will require that any entity receiving
amounts from the grant for operating a program of treatment for substance abuse—
(A) will, directly or through arrangements
with other public or nonprofit private entities, routinely make available tuberculosis
services to each individual receiving treatment for such abuse; and
(B) in the case of an individual in need of
such treatment who is denied admission to
the program on the basis of the lack of the
capacity of the program to admit the individual, will refer the individual to another
provider of tuberculosis services.
(2) Tuberculosis services
For purposes of paragraph (1), the term ‘‘tuberculosis services’’, with respect to an individual, means—
(A) counseling the individual with respect
to tuberculosis;

Page 1111

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) testing to determine whether the individual has contracted such disease and testing to determine the form of treatment for
the disease that is appropriate for the individual; and
(C) providing such treatment to the individual.
(b) Human immunodeficiency virus
(1) Requirement for certain States
In the case of a State described in paragraph
(2), a funding agreement for a grant under section 300x–21 of this title is that—
(A) with respect to individuals undergoing
treatment for substance abuse, the State
will, subject to paragraph (3), carry out 1 or
more projects to make available to the individuals early intervention services for HIV
disease at the sites at which the individuals
are undergoing such treatment;
(B) for the purpose of providing such early
intervention services through such projects,
the State will make available from the grant
the percentage that is applicable for the
State under paragraph (4); and
(C) the State will, subject to paragraph (5),
carry out such projects only in geographic
areas of the State that have the greatest
need for the projects.
(2) Designated States
For purposes of this subsection, a State described in this paragraph is any State whose
rate of cases of acquired immune deficiency
syndrome is 10 or more such cases per 100,000
individuals (as indicated by the number of
such cases reported to and confirmed by the
Director of the Centers for Disease Control for
the most recent calendar year for which such
data are available).
(3) Use of existing programs regarding substance abuse
With respect to programs that provide treatment services for substance abuse, a funding
agreement for a grant under section 300x–21 of
this title for a designated State is that each
such program participating in a project under
paragraph (1) will be a program that began operation prior to the fiscal year for which the
State is applying to receive the grant. A program that so began operation may participate
in a project under paragraph (1) without regard to whether the program has been providing early intervention services for HIV disease.
(4) Applicable percentage regarding expenditures for services
(A)(i) For purposes of paragraph (1)(B), the
percentage that is applicable under this paragraph for a designated State is, subject to subparagraph (B), the percentage by which the
amount of the grant under section 300x–21 of
this title for the State for the fiscal year involved is an increase over the amount specified in clause (ii).
(ii) The amount specified in this clause is
the amount that was reserved by the designated State involved from the allotment of
the State under section 300x–1a 1 of this title
1 See

References in Text note below.

§ 300x–24

for fiscal year 1991 in compliance with section
300x–4(c)(6)(A)(ii) 1 of this title (as such sections were in effect for such fiscal year).
(B) If the percentage determined under subparagraph (A) for a designated State for a fiscal year is less than 2 percent (including a
negative percentage, in the case of a State for
which there is no increase for purposes of such
subparagraph), the percentage applicable
under this paragraph for the State is 2 percent. If the percentage so determined is 2 percent or more, the percentage applicable under
this paragraph for the State is the percentage
determined under subparagraph (A), subject to
not exceeding 5 percent.
(5) Requirement regarding rural areas
(A) A funding agreement for a grant under
section 300x–21 of this title for a designated
State is that, if the State will carry out 2 or
more projects under paragraph (1), the State
will carry out 1 such project in a rural area of
the State, subject to subparagraph (B).
(B) The Secretary shall waive the requirement established in subparagraph (A) if the
State involved certifies to the Secretary
that—
(i) there is insufficient demand in the
State to carry out a project under paragraph
(1) in any rural area of the State; or
(ii) there are no rural areas in the State.
(6) Manner of providing services
With respect to the provision of early intervention services for HIV disease to an individual, a funding agreement for a grant under
section 300x–21 of this title for a designated
State is that—
(A) such services will be undertaken voluntarily by, and with the informed consent of,
the individual; and
(B) undergoing such services will not be required as a condition of receiving treatment
services for substance abuse or any other
services.
(7) Definitions
For purposes of this subsection:
(A) The term ‘‘designated State’’ means a
State described in paragraph (2).
(B) The term ‘‘early intervention services’’, with respect to HIV disease, means—
(i) appropriate pretest counseling;
(ii) testing individuals with respect to
such disease, including tests to confirm
the presence of the disease, tests to diagnose the extent of the deficiency in the immune system, and tests to provide information on appropriate therapeutic measures for preventing and treating the deterioration of the immune system and for
preventing and treating conditions arising
from the disease;
(iii) appropriate post-test counseling;
and
(iv) providing the therapeutic measures
described in clause (ii).
(C) The term ‘‘HIV disease’’ means infection with the etiologic agent for acquired
immune deficiency syndrome.

§ 300x–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Expenditure of grant for compliance with
agreements
(1) In general
A grant under section 300x–21 of this title
may be expended for purposes of compliance
with the agreements required in this section,
subject to paragraph (2).
(2) Limitation
A funding agreement for a grant under section 300x–21 of this title for a State is that the
grant will not be expended to make payment
for any service provided for purposes of compliance with this section to the extent that
payment has been made, or can reasonably be
expected to be made, with respect to such
service—
(A) under any State compensation program, under any insurance policy, or under
any Federal or State health benefits program (including the program established in
title XVIII of the Social Security Act [42
U.S.C. 1395 et seq.] and the program established in title XIX of such Act [42 U.S.C. 1396
et seq.]); or
(B) by an entity that provides health services on a prepaid basis.
(d) Maintenance of effort
With respect to services provided for by a
State for purposes of compliance with this section, a funding agreement for a grant under section 300x–21 of this title is that the State will
maintain expenditures of non-Federal amounts
for such services at a level that is not less than
average level of such expenditures maintained
by the State for 2-year period preceding the first
fiscal year for which the State receives such a
grant.
(e) Applicability of certain provision
Section 300x–31 of this title applies to this section (and to each other provision of this subpart).
(July 1, 1944, ch. 373, title XIX, § 1924, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 391.)
REFERENCES IN TEXT
Section 300x–1a of this title, referred to in subsec.
(b)(4)(A)(ii), was repealed by Pub. L. 102–321, title II,
§ 201(2), July 10, 1992, 106 Stat. 378.
Section 300x–4 of this title, referred to in subsec.
(b)(4)(A)(ii), was in the original a reference to section
1916 of act July 1, 1944, which was repealed by Pub. L.
102–321, title II, § 201(2), July 10, 1992, 106 Stat. 378. Section 201(2) of Pub. L. 102–321 enacted new sections 1915
and 1916 of act July 1, 1944, which are classified to sections 300x–4 and 300x–5, respectively, of this title.
The Social Security Act, referred to in subsec.
(c)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Titles XVIII and XIX of the Act are classified
generally to subchapters XVIII (§ 1395 et seq.) and XIX
(§ 1396 et seq.) of chapter 7 of this title. For complete
classification of this Act to the Code, see section 1305
of this title and Tables.
PRIOR PROVISIONS
A prior section 1924 of act July 1, 1944, was classified
to section 300x–10 of this title prior to repeal by Pub. L.
102–321.
Another prior section 1924 of act July 1, 1944, was
classified to section 300y–3 of this title prior to repeal
by Pub. L. 99–280.

Page 1112

CHANGE OF NAME
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.

§ 300x–25. Group homes for recovering substance
abusers
(a) State revolving funds for establishment of
homes
A State, using funds available under section
300x–21 of this title, may establish and maintain
the ongoing operation of a revolving fund in accordance with this section to support group
homes for recovering substance abusers as follows:
(1) The purpose of the fund is to make loans
for the costs of establishing programs for the
provision of housing in which individuals recovering from alcohol or drug abuse may reside in groups of not less than 6 individuals.
The fund is established directly by the State
or through the provision of a grant or contract
to a nonprofit private entity.
(2) The programs are carried out in accordance with guidelines issued under subsection
(b) of this section.
(3) Not less than $100,000 is available for the
fund.
(4) Loans made from the revolving fund do
not exceed $4,000 and each such loan is repaid
to the revolving fund by the residents of the
housing involved not later than 2 years after
the date on which the loan is made.
(5) Each such loan is repaid by such residents through monthly installments, and a
reasonable penalty is assessed for each failure
to pay such periodic installments by the date
specified in the loan agreement involved.
(6) Such loans are made only to nonprofit
private entities agreeing that, in the operation of the program established pursuant to
the loan—
(A) the use of alcohol or any illegal drug in
the housing provided by the program will be
prohibited;
(B) any resident of the housing who violates such prohibition will be expelled from
the housing;
(C) the costs of the housing, including fees
for rent and utilities, will be paid by the
residents of the housing; and
(D) the residents of the housing will,
through a majority vote of the residents,
otherwise establish policies governing residence in the housing, including the manner
in which applications for residence in the
housing are approved.
(b) Issuance by Secretary of guidelines
The Secretary shall ensure that there are in
effect guidelines under this subpart for the operation of programs described in subsection (a) of
this section.
(c) Applicability to territories
The requirements established in subsection (a)
of this section shall not apply to any territory
of the United States other than the Commonwealth of Puerto Rico.
(July 1, 1944, ch. 373, title XIX, § 1925, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106

Page 1113

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 393; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(b), Oct. 17, 2000, 114 Stat. 1210.)
PRIOR PROVISIONS
A prior section 1925 of act July 1, 1944, was classified
to section 300x–11 of this title prior to repeal by Pub. L.
102–321.
Another prior section 1925 of act July 1, 1944, was
classified to section 300y–4 of this title prior to repeal
by Pub. L. 99–280.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, in introductory provisions, substituted ‘‘A State, using funds available
under section 300x–21 of this title, may establish and
maintain the ongoing operation of a revolving fund in
accordance with this section to support group homes
for recovering substance abusers as follows:’’ for ‘‘For
fiscal year 1993 and subsequent fiscal years, the Secretary may make a grant under section 300x–21 of this
title only if the State involved has established, and is
providing for the ongoing operation of, a revolving fund
as follows:’’.

§ 300x–26. State law regarding sale of tobacco
products to individuals under age of 18
(a) Relevant law
(1) In general
Subject to paragraph (2), for fiscal year 1994
and subsequent fiscal years, the Secretary
may make a grant under section 300x–21 of this
title only if the State involved has in effect a
law providing that it is unlawful for any manufacturer, retailer, or distributor of tobacco
products to sell or distribute any such product
to any individual under the age of 18.
(2) Delayed applicability for certain States
In the case of a State whose legislature does
not convene a regular session in fiscal year
1993, and in the case of a State whose legislature does not convene a regular session in fiscal year 1994, the requirement described in
paragraph (1) as a condition of a receipt of a
grant under section 300x–21 of this title shall
apply only for fiscal year 1995 and subsequent
fiscal years.
(b) Enforcement
(1) In general
For the first applicable fiscal year and for
subsequent fiscal years, a funding agreement
for a grant under section 300x–21 of this title is
that the State involved will enforce the law
described in subsection (a) of this section in a
manner that can reasonably be expected to reduce the extent to which tobacco products are
available to individuals under the age of 18.
(2) Activities and reports regarding enforcement
For the first applicable fiscal year and for
subsequent fiscal years, a funding agreement
for a grant under section 300x–21 of this title is
that the State involved will—
(A) annually conduct random, unannounced inspections to ensure compliance
with the law described in subsection (a) of
this section; and
(B) annually submit to the Secretary a report describing—
(i) the activities carried out by the State
to enforce such law during the fiscal year

§ 300x–26a

preceding the fiscal year for which the
State is seeking the grant;
(ii) the extent of success the State has
achieved in reducing the availability of tobacco products to individuals under the
age of 18; and
(iii) the strategies to be utilized by the
State for enforcing such law during the fiscal year for which the grant is sought.
(c) Noncompliance of State
Before making a grant under section 300x–21 of
this title to a State for the first applicable fiscal
year or any subsequent fiscal year, the Secretary shall make a determination of whether
the State has maintained compliance with subsections (a) and (b) of this section. If, after notice to the State and an opportunity for a hearing, the Secretary determines that the State is
not in compliance with such subsections, the
Secretary shall reduce the amount of the allotment under such section for the State for the
fiscal year involved by an amount equal to—
(1) in the case of the first applicable fiscal
year, 10 percent of the amount determined
under section 300x–33 of this title for the State
for the fiscal year;
(2) in the case of the first fiscal year following such applicable fiscal year, 20 percent of
the amount determined under section 300x–33
of this title for the State for the fiscal year;
(3) in the case of the second such fiscal year,
30 percent of the amount determined under
section 300x–33 of this title for the State for
the fiscal year; and
(4) in the case of the third such fiscal year or
any subsequent fiscal year, 40 percent of the
amount determined under section 300x–33 of
this title for the State for the fiscal year.
(d) ‘‘First applicable fiscal year’’ defined
For purposes of this section, the term ‘‘first
applicable fiscal year’’ means—
(1) fiscal year 1995, in the case of any State
described in subsection (a)(2) of this section;
and
(2) fiscal year 1994, in the case of any other
State.
(July 1, 1944, ch. 373, title XIX, § 1926, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 394.)
PRIOR PROVISIONS
A prior section 1926 of act July 1, 1944, was classified
to section 300x–12 of this title prior to repeal by Pub. L.
102–321.
Another prior section 1926 of act July 1, 1944, was
classified to section 300y–5 of this title prior to repeal
by Pub. L. 99–280.

§ 300x–26a. Withholding of substance abuse funding under section 300x–26
(a) No withholding from States committing additional funds for tobacco sale compliance
Except as provided by subsection (e) none of
the funds appropriated for fiscal year 2010 or any
subsequent fiscal year by this or any subsequent
appropriations Act may be used to withhold substance abuse funding from a State pursuant to
section 300x–26 of this title if such State certifies to the Secretary of Health and Human

§ 300x–27

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Services by May 1 of the fiscal year for which
the funds are appropriated, that the State will
commit additional State funds, in accordance
with subsection (b), to ensure compliance with
State laws prohibiting the sale of tobacco products to individuals under 18 years of age.
(b) Amount to be committed
The amount of funds to be committed by a
State under subsection (a) shall be equal to 1
percent of such State’s substance abuse block
grant allocation for each percentage point by
which the State misses the retailer compliance
rate goal established by the Secretary under
section 300x–26 of this title.
(c) Maintenance of expenditures for tobacco prevention programs and compliance activities
The State is to maintain State expenditures in
such fiscal year for tobacco prevention programs
and for compliance activities at a level that is
not less than the level of such expenditures
maintained by the State for the preceding fiscal
year, and adding to that level the additional
funds for tobacco compliance activities required
under subsection (a). The State is to submit a
report to the Secretary on all State obligations
of funds for such fiscal year and all State expenditures for the preceding fiscal year for tobacco prevention and compliance activities by
program activity by July 31 of such fiscal year.
(d) Timing of State obligation of additional funds
The Secretary shall exercise discretion in enforcing the timing of the State obligation of the
additional funds required by the certification
described in subsection (a) as late as July 31 of
such fiscal year.
(e) Withholding from territories
None of the funds appropriated by this or any
subsequent appropriations Act may be used to
withhold substance abuse funding pursuant to
section 300x–26 of this title from a territory that
receives less than $1,000,000.
(Pub. L. 111–117, div. D, title II, § 212, Dec. 16,
2009, 123 Stat. 3257.)
CODIFICATION
Section was enacted as part of the Department of
Health and Human Services Appropriations Act, 2010,
and also as part of the Departments of Labor, Health
and Human Services, and Education, and Related Agencies Appropriations Act, 2010, and the Consolidated Appropriations Act, 2010, and not as part of the Public
Health Service Act which comprises this chapter.

§ 300x–27. Treatment
women

services

for

pregnant

(a) In general
A funding agreement for a grant under section
300x–21 of this title is that the State involved—
(1) will ensure that each pregnant woman in
the State who seeks or is referred for and
would benefit from such services is given preference in admissions to treatment facilities
receiving funds pursuant to the grant; and
(2) will, in carrying out paragraph (1), publicize the availability to such women of services from the facilities and the fact that the
women receive such preference.

Page 1114

(b) Referrals regarding States
A funding agreement for a grant under section
300x–21 of this title is that, in carrying out subsection (a)(1) of this section—
(1) the State involved will require that, in
the event that a treatment facility has insufficient capacity to provide treatment services
to any woman described in such subsection
who seeks the services from the facility, the
facility refer the woman to the State; and
(2) the State, in the case of each woman for
whom a referral under paragraph (1) is made
to the State—
(A) will refer the woman to a treatment facility that has the capacity to provide treatment services to the woman; or
(B) will, if no treatment facility has the
capacity to admit the woman, make interim
services available to the woman not later
than 48 hours after the women 1 seeks the
treatment services.
(July 1, 1944, ch. 373, title XIX, § 1927, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 395; amended Pub. L. 102–352, § 2(a)(10),
Aug. 26, 1992, 106 Stat. 938.)
PRIOR PROVISIONS
A prior section 1927 of act July 1, 1944, was classified
to section 300x–12 of this title prior to repeal by Pub. L.
102–321.
Another prior section 1927 of act July 1, 1944, was
classified to section 300y–6 of this title prior to repeal
by Pub. L. 99–280.
AMENDMENTS
1992—Subsec. (b)(2)(B). Pub. L. 102–352 struck out
‘‘available’’ before ‘‘interim services available’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.

§ 300x–28. Additional agreements
(a) Improvement of process for appropriate referrals for treatment
With respect to individuals seeking treatment
services, a funding agreement for a grant under
section 300x–21 of this title is that the State involved will improve (relative to fiscal year 1992)
the process in the State for referring the individuals to treatment facilities that can provide
to the individuals the treatment modality that
is most appropriate for the individuals.
(b) Continuing education
With respect to any facility for treatment
services or prevention actitivities 1 that is receiving amounts from a grant under section
300x–21 of this title, a funding agreement for a
State for a grant under such section is that continuing education in such services or activities
(or both, as the case may be) will be made available to employees of the facility who provide the
services or activities.
(c) Coordination of various activities and services
A funding agreement for a grant under section
300x–21 of this title is that the State involved
1 So
1 So

in original. Probably should be ‘‘woman’’.
in original. Probably should be ‘‘activities’’.

Page 1115

TITLE 42—THE PUBLIC HEALTH AND WELFARE

will coordinate prevention and treatment activities with the provision of other appropriate
services (including health, social, correctional
and criminal justice, educational, vocational rehabilitation, and employment services).
(d) Waiver of requirement
(1) In general
Upon the request of a State, the Secretary
may provide to a State a waiver of any or all
of the requirements established in this section
if the Secretary determines that, with respect
to services for the prevention and treatment
of substance abuse, the requirement involved
is unnecessary for maintaining quality in the
provision of such services in the State.
(2) Date certain for acting upon request
The Secretary shall approve or deny a request for a waiver under paragraph (1) not
later than 120 days after the date on which the
request is made.
(3) Applicability of waiver
Any waiver provided by the Secretary under
paragraph (1) shall be applicable only to the
fiscal year involved.
(July 1, 1944, ch. 373, title XIX, § 1928, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 396; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(f)(2)(B), Oct. 17, 2000, 114 Stat.
1211.)
REPEAL OF SUBSECTION (d)
Pub. L. 106–310, div. B, title XXXIII,
§ 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that, effective upon publication of regulations developed in accordance with section
300x–32(e)(1) of this title, subsection (d) of this
section is repealed.
PRIOR PROVISIONS
A prior section 1928 of act July 1, 1944, was classified
to section 300y–7 of this title prior to repeal by Pub. L.
99–280.
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–310, div. B, title XXXIII, § 3303(f)(2), Oct.
17, 2000, 114 Stat. 1211, provided that the amendment
made by section 3303(f)(2) is effective upon the publication of the regulations developed in accordance with
section 300x–32(e)(1) of this title.

§ 300x–29. Submission to Secretary of statewide
assessment of needs
The Secretary may make a grant under section 300x–21 of this title only if the State submits to the Secretary an assessment of the need
in the State for authorized activities (which assessment is conducted in accordance with criteria issued by the Secretary), both by locality
and by the State in general, which assessment
includes a description of—
(1) the incidence and prevalence in the State
of drug abuse and the incidence and prevalence
in the State of alcohol abuse and alcoholism;
(2) current prevention and treatment activities in the State;
(3) the need of the State for technical assistance to carry out such activities;
(4) efforts by the State to improve such activities; and

§ 300x–30

(5) the extent to which the availability of
such activities is insufficient to meet the need
for the activities, the interim services to be
made available under sections 300x–23(a) and
300x–27(b) of this title, and the manner in
which such services are to be so available.
(July 1, 1944, ch. 373, title XIX, § 1929, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 396.)
PRIOR PROVISIONS
A prior section 1929 of act July 1, 1944, was classified
to section 300y–8 of this title prior to repeal by Pub. L.
99–280.

§ 300x–30. Maintenance of effort regarding State
expenditures
(a) In general
With respect to the principal agency of a State
for carrying out authorized activities, a funding
agreement for a grant under section 300x–21 of
this title for the State for a fiscal year is that
such agency will for such year maintain aggregate State expenditures for authorized activities
at a level that is not less than the average level
of such expenditures maintained by the State
for the 2-year period preceding the fiscal year
for which the State is applying for the grant.
(b) Exclusion of certain funds
The Secretary may exclude from the aggregate State expenditures under subsection (a) of
this section, funds appropriated to the principle
agency for authorized activities which are of a
non-recurring nature and for a specific purpose.
(c) Waiver
(1) In general
Upon the request of a State, the Secretary
may waive all or part of the requirement established in subsection (a) of this section if
the Secretary determines that extraordinary
economic conditions in the State justify the
waiver.
(2) Date certain for acting upon request
The Secretary shall approve or deny a request for a waiver under paragraph (1) not
later than 120 days after the date on which the
request is made.
(3) Applicability of waiver
Any waiver provided by the Secretary under
paragraph (1) shall be applicable only to the
fiscal year involved.
(d) Noncompliance by State
(1) In general
In making a grant under section 300x–21 of
this title to a State for a fiscal year, the Secretary shall make a determination of whether,
for the previous fiscal year, the State maintained material compliance with any agreement made under subsection (a) of this section. If the Secretary determines that a State
has failed to maintain such compliance, the
Secretary shall reduce the amount of the allotment under section 300x–21 of this title for
the State for the fiscal year for which the
grant is being made by an amount equal to the
amount constituting such failure for the previous fiscal year.

§ 300x–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Submission of information to Secretary
The Secretary may make a grant under section 300x–21 of this title for a fiscal year only
if the State involved submits to the Secretary
information sufficient for the Secretary to
make the determination required in paragraph
(1).
(July 1, 1944, ch. 373, title XIX, § 1930, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 397; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(c), Oct. 17, 2000, 114 Stat. 1210.)
PRIOR PROVISIONS
A prior section 1930 of act July 1, 1944, was classified
to section 300y–9 of this title prior to repeal by Pub. L.
99–280.
AMENDMENTS
2000—Subsecs. (b) to (d). Pub. L. 106–310 added subsec.
(b) and redesignated former subsecs. (b) and (c) as (c)
and (d), respectively.

§ 300x–31. Restrictions on expenditure of grant
(a) In general
(1) Certain restrictions
A funding agreement for a grant under section 300x–21 of this title is that the State involved will not expend the grant—
(A) to provide inpatient hospital services,
except as provided in subsection (b) of this
section;
(B) to make cash payments to intended recipients of health services;
(C) to purchase or improve land, purchase,
construct, or permanently improve (other
than minor remodeling) any building or
other facility, or purchase major medical
equipment;
(D) to satisfy any requirement for the expenditure of non-Federal funds as a condition for the receipt of Federal funds;
(E) to provide financial assistance to any
entity other than a public or nonprofit private entity; or
(F) to carry out any program prohibited by
section 300ee–5 of this title.
(2) Limitation on administrative expenses
A funding agreement for a grant under section 300x–21 of this title is that the State involved will not expend more than 5 percent of
the grant to pay the costs of administering the
grant.
(3) Limitation regarding penal and correctional institutions
A funding agreement for a State for a grant
under section 300x–21 of this title is that, in
expending the grant for the purpose of providing treatment services in penal or correctional
institutions of the State, the State will not
expend more than an amount equal to the
amount expended for such purpose by the
State from the grant made under section
300x–1a 1 of this title to the State for fiscal
year 1991 (as section 300x–1a 1 of this title was
in effect for such fiscal year).
1 See

References in Text note below.

Page 1116

(b) Exception regarding inpatient hospital services
(1) Medical necessity as precondition
With respect to compliance with the agreement made under subsection (a) of this section, a State may expend a grant under section 300x–21 of this title to provide inpatient
hospital services as treatment for substance
abuse only if it has been determined, in accordance with guidelines issued by the Secretary, that such treatment is a medical necessity for the individual involved, and that
the individual cannot be effectively treated in
a community-based, nonhospital, residential
program of treatment.
(2) Rate of payment
In the case of an individual for whom a grant
under section 300x–21 of this title is expended
to provide inpatient hospital services described in paragraph (1), a funding agreement
for the grant for the State involved is that the
daily rate of payment provided to the hospital
for providing the services to the individual
will not exceed the comparable daily rate provided for community-based, nonhospital, residential programs of treatment for substance
abuse.
(c) Waiver regarding construction of facilities
(1) In general
The Secretary may provide to any State a
waiver of the restriction established in subsection (a)(1)(C) of this section for the purpose
of authorizing the State to expend a grant
under section 300x–21 of this title for the construction of a new facility or rehabilitation of
an existing facility, but not for land acquisition.
(2) Standard regarding need for waiver
The Secretary may approve a waiver under
paragraph (1) only if the State demonstrates
to the Secretary that adequate treatment cannot be provided through the use of existing facilities and that alternative facilities in existing suitable buildings are not available.
(3) Amount
In granting a waiver under paragraph (1), the
Secretary shall allow the use of a specified
amount of funds to construct or rehabilitate a
specified number of beds for residential treatment and a specified number of slots for outpatient treatment, based on reasonable estimates by the State of the costs of construction or rehabilitation. In considering waiver
applications, the Secretary shall ensure that
the State has carefully designed a program
that will minimize the costs of additional
beds.
(4) Matching funds
The Secretary may grant a waiver under
paragraph (1) only if the State agrees, with respect to the costs to be incurred by the State
in carrying out the purpose of the waiver, to
make available non-Federal contributions in
cash toward such costs in an amount equal to
not less than $1 for each $1 of Federal funds
provided under section 300x–21 of this title.

Page 1117

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Date certain for acting upon request
The Secretary shall act upon a request for a
waiver under paragraph (1) not later than 120
days after the date on which the request is
made.
(July 1, 1944, ch. 373, title XIX, § 1931, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 397.)
REFERENCES IN TEXT
Section 300x–1a of this title, referred to in subsec.
(a)(3), was repealed by Pub. L. 102–321, title II, § 201(2),
July 10, 1992, 106 Stat. 378.
PRIOR PROVISIONS
A prior section 1931 of act July 1, 1944, was classified
to section 300y–21 of this title and subsequently omitted from the Code.
Another prior section 1931 of act July 1, 1944, was
classified to section 300y–10 of this title prior to repeal
by Pub. L. 99–280.

§ 300x–32. Application for grant; approval of
State plan
(a) In general
For purposes of section 300x–21 of this title, an
application for a grant under such section for a
fiscal year is in accordance with this section if,
subject to subsections (c) and (d)(2) of this section—
(1) the application is received by the Secretary not later than October 1 of the fiscal
year for which the State is seeking funds;
(2) the application contains each funding
agreement that is described in this subpart or
subpart III for such a grant (other than any
such agreement that is not applicable to the
State);
(3) the agreements are made through certification from the chief executive officer of the
State;
(4) with respect to such agreements, the application provides assurances of compliance
satisfactory to the Secretary;
(5) the application contains the information
required in section 300x–29 of this title, the information required in section 300x–30(c)(2) 1 of
this title, and the report required in section
300x–52(a) of this title;
(6)(A) the application contains a plan in accordance with subsection (b) of this section
and the plan is approved by the Secretary; and
(B) the State provides assurances satisfactory to the Secretary that the State complied
with the provisions of the plan under subparagraph (A) that was approved by the Secretary
for the most recent fiscal year for which the
State received a grant under section 300x–21 of
this title; and
(7) the application (including the plan under
paragraph (6)) is otherwise in such form, is
made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this subpart.
(b) State plan
(1) In general
A plan submitted by a State under subsection (a)(6) of this section is in accordance
1 See

References in Text note below.

§ 300x–32

with this subsection if the plan contains detailed provisions for complying with each
funding agreement for a grant under section
300x–21 of this title that is applicable to the
State, including a description of the manner
in which the State intends to expend the
grant.
(2) Authority of Secretary regarding modifications
As a condition of making a grant under section 300x–21 of this title to a State for a fiscal
year, the Secretary may require that the
State modify any provision of the plan submitted by the State under subsection (a)(6) of
this section (including provisions on priorities
in carrying out authorized activities). If the
Secretary approves the plan and makes the
grant to the State for the fiscal year, the Secretary may not during such year require the
State to modify the plan.
(3) Authority of Center for Substance Abuse
Prevention
With respect to plans submitted by the
States under subsection (a)(6) of this section,
the Secretary, acting through the Director of
the Center for Substance Abuse Prevention,
shall review and approve or disapprove the
provisions of the plans that relate to prevention activities.
(c) Waivers regarding certain territories
In the case of any territory of the United
States except Puerto Rico, the Secretary may
waive such provisions of this subpart and subpart III as the Secretary determines to be appropriate, other than the provisions of section
300x–31 of this title.
(d) Issuance of regulations; precondition to making grants
(1) Regulations
Not later than August 25, 1992, the Secretary, acting as appropriate through the Director of the Center for Treatment Improvement or the Director of the Center for Substance Abuse Prevention, shall by regulation
establish standards specifying the circumstances in which the Secretary will consider
an application for a grant under section
300x–21 of this title to be in accordance with
this section.
(2) Issuance as precondition to making grants
The Secretary may not make payments
under any grant under section 300x–21 of this
title for fiscal year 1993 on or after January 1,
1993, unless the Secretary has issued standards
under paragraph (1).
(e) Waiver authority for certain requirements
(1) In general
Upon the request of a State, the Secretary
may waive the requirements of all or part of
the sections described in paragraph (2) using
objective criteria established by the Secretary
by regulation after consultation with the
States and other interested parties including
consumers and providers.
(2) Sections
The sections described in paragraph (1) are
sections 300x–22(c) 1, 300x–23, 300x–24 and
300x–28 of this title.

§ 300x–33

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Date certain for acting upon request
The Secretary shall approve or deny a request for a waiver under paragraph (1) and inform the State of that decision not later than
120 days after the date on which the request
and all the information needed to support the
request are submitted.
(4) Annual reporting requirement
The Secretary shall annually report to the
general public on the States that receive a
waiver under this subsection.
(July 1, 1944, ch. 373, title XIX, § 1932, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 399; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(d)–(f)(1), Oct. 17, 2000, 114 Stat.
1211.)
REFERENCES IN TEXT
Section 300x–30(c) of this title, referred to in subsec.
(a)(5), was redesignated section 300x–30(d) of this title
by Pub. L. 106–310, div. B, title XXXIII, § 3303(c)(1), Oct.
17, 2000, 114 Stat. 1211.
Section 300x–22(c) of this title, referred to in subsec.
(e)(2), was redesignated section 300x–22(b) of this title
by Pub. L. 106–310, div. B, title XXXIII, § 3303(a)(2), Oct.
17, 2000, 114 Stat. 1210.
PRIOR PROVISIONS
A prior section 1932 of act July 1, 1944, was classified
to section 300y–22 of this title and subsequently omitted from the Code.
Another prior section 1932 of act July 1, 1944, was
classified to section 300y–11 of this title prior to repeal
by Pub. L. 99–280.
AMENDMENTS
2000—Subsec. (a)(1). Pub. L. 106–310, § 3303(d), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘the State involved submits the application
not later than the date specified by the Secretary;’’.
Subsec. (c). Pub. L. 106–310, § 3303(e), substituted ‘‘except Puerto Rico’’ for ‘‘whose allotment under section
300x–21 of this title for the fiscal year is the amount
specified in section 300x–33(c)(2)(B) of this title’’.
Subsec. (e). Pub. L. 106–310, § 3303(f)(1), added subsec.
(e).

§ 300x–33. Determination of amount of allotment
(a) States
(1) In general
Subject to subsection (b) of this section, the
Secretary shall determine the amount of the
allotment required in section 300x–21 of this
title for a State for a fiscal year as follows:
(A) The formula established in paragraph
(1) of section 300x–7(a) of this title shall
apply to this subsection to the same extent
and in the same manner as the formula applies for purposes of section 300x–7(a) of this
title, except that, in the application of such
formula for purposes of this subsection, the
modifications described in subparagraph (B)
shall apply.
(B) For purposes of subparagraph (A), the
modifications described in this subparagraph
are as follows:
(i) The amount specified in paragraph
(2)(A) of section 300x–7(a) of this title is
deemed to be the amount appropriated
under section 300x–35(a) of this title for allotments under section 300x–21 of this title
for the fiscal year involved.

Page 1118

(ii) The term ‘‘P’’ is deemed to have the
meaning given in paragraph (2) of this subsection. Section 300x–7(a)(5)(B) of this title
applies to the data used in determining
such term for the States.
(iii) The factor determined under paragraph (8) of section 300x–7(a) of this title is
deemed to have the purpose of reflecting
the differences that exist between the
State involved and other States in the
costs of providing authorized services.
(2) Determination of term ‘‘P’’
For purposes of this subsection, the term
‘‘P’’ means the percentage that is the arithmetic mean of the percentage determined
under subparagraph (A) and the percentage determined under subparagraph (B), as follows:
(A) The percentage constituted by the
ratio of—
(i) an amount equal to the sum of the
total number of individuals who reside in
the State involved and are between 18 and
24 years of age (inclusive) and the number
of individuals in the State who reside in
urbanized areas of the State and are between such years of age; to
(ii) an amount equal to the total of the
respective sums determined for the States
under clause (i).
(B) The percentage constituted by the
ratio of—
(i) the total number of individuals in the
State who are between 25 and 64 years of
age (inclusive); to
(ii) an amount equal to the sum of the
respective amounts determined for the
States under clause (i).
(b) Minimum allotments for States
(1) In general
With respect to fiscal year 2000, and each
subsequent fiscal year, the amount of the allotment of a State under section 300x–21 of
this title shall not be less than the amount the
State received under such section for the previous fiscal year increased by an amount equal
to 30.65 percent of the percentage by which the
aggregate amount allotted to all States for
such fiscal year exceeds the aggregate amount
allotted to all States for the previous fiscal
year.
(2) Limitations
(A) In general
Except as provided in subparagraph (B), a
State shall not receive an allotment under
section 300x–21 of this title for a fiscal year
in an amount that is less than an amount
equal to 0.375 percent of the amount appropriated under section 300x–35(a) of this title
for such fiscal year.
(B) Exception
In applying subparagraph (A), the Secretary shall ensure that no State receives an
increase in its allotment under section
300x–21 of this title for a fiscal year (as compared to the amount allotted to the State in
the prior fiscal year) that is in excess of an
amount equal to 300 percent of the percent-

Page 1119

TITLE 42—THE PUBLIC HEALTH AND WELFARE

age by which the amount appropriated under
section 300x–35(a) of this title for such fiscal
year exceeds the amount appropriated for
the prior fiscal year.
(3) Decrease in or equal appropriations
If the amount appropriated under section
300x–35(a) of this title for a fiscal year is equal
to or less than the amount appropriated under
such section for the prior fiscal year, the
amount of the State allotment under section
300x–21 of this title shall be equal to the
amount that the State received under section
300x–21 of this title in the prior fiscal year decreased by the percentage by which the
amount appropriated for such fiscal year is
less than the amount appropriated or 1 such
section for the prior fiscal year.
(c) Territories
(1) Determination under formula
Subject to paragraphs (2) and (4), the
amount of an allotment under section 300x–21
of this title for a territory of the United
States for a fiscal year shall be the product
of—
(A) an amount equal to the amounts reserved under paragraph (3) for the fiscal
year; and
(B) a percentage equal to the quotient of—
(i) the civilian population of the territory, as indicated by the most recently
available data; divided by
(ii) the aggregate civilian population of
the territories of the United States, as indicated by such data.
(2) Minimum allotment for territories
The amount of an allotment under section
300x–21 of this title for a territory of the
United States for a fiscal year shall be the
greater of—
(A) the amount determined under paragraph (1) for the territory for the fiscal year;
(B) $50,000; and
(C) with respect to fiscal years 1993 and
1994, an amount equal to 79.4 percent of the
amount received by the territory from allotments made pursuant to this part for fiscal
year 1992.
(3) Reservation of amounts
The Secretary shall each fiscal year reserve
for the territories of the United States 1.5 percent of the amounts appropriated under section 300x–35(a) of this title for allotments
under section 300x–21 of this title for the fiscal
year.
(4) Availability of data on population
With respect to data on the civilian population of the territories of the United States,
if the Secretary determines for a fiscal year
that recent such data for purposes of paragraph (1)(B) do not exist regarding a territory,
the Secretary shall for such purposes estimate
the civilian population of the territory by
modifying the data on the territory to reflect
the average extent of change occurring during
the ensuing period in the population of all ter-

ritories with respect to which recent such data
do exist.
(5) Applicability of certain provisions
For purposes of subsections (a) and (b) of
this section, the term ‘‘State’’ does not include the territories of the United States.
(d) Indian tribes and tribal organizations
(1) In general
If the Secretary—
(A) receives a request from the governing
body of an Indian tribe or tribal organization within any State that funds under this
subpart be provided directly by the Secretary to such tribe or organization; and
(B) makes a determination that the members of such tribe or tribal organization
would be better served by means of grants
made directly by the Secretary under this; 2
the Secretary shall reserve from the allotment
under section 300x–21 of this title for the State
for the fiscal year involved an amount that
bears the same ratio to the allotment as the
amount provided under this subpart to the
tribe or tribal organization for fiscal year 1991
for activities relating to the prevention and
treatment of the abuse of alcohol and other
drugs bore to the amount of the portion of the
allotment under this subpart for the State for
such fiscal year that was expended for such activities.
(2) Tribe or tribal organization as grantee
The amount reserved by the Secretary on
the basis of a determination under this paragraph 3 shall be granted to the Indian tribe or
tribal organization serving the individuals for
whom such a determination has been made.
(3) Application
In order for an Indian tribe or tribal organization to be eligible for a grant for a fiscal
year under this paragraph,3 it shall submit to
the Secretary a plan for such fiscal year that
meets such criteria as the Secretary may prescribe.
(4) Definitions
The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such
terms in subsections (b) and (c) 4 of section
450b of title 25.
(July 1, 1944, ch. 373, title XIX, § 1933, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 400; amended Pub. L. 102–352, § 2(a)(11),
Aug. 26, 1992, 106 Stat. 938; Pub. L. 105–277, div.
A, § 101(f) [title II, § 218(b)], Oct. 21, 1998, 112 Stat.
2681–337, 2681–362; Pub. L. 106–113, div. B,
§ 1000(a)(4) [title II, § 212(b)], Nov. 29, 1999, 113
Stat. 1535, 1501A–239; Pub. L. 106–310, div. B, title
XXXIII, § 3304, Oct. 17, 2000, 114 Stat. 1212.)
REFERENCES IN TEXT
Section 450b of title 25, referred to in subsec. (d)(4),
was amended, and subsecs. (b) and (c) of section 450 no
longer define the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’. However, such terms are defined elsewhere
in that section.
2 So

in original. Probably should be ‘‘this subpart;’’.
in original. Probably should be ‘‘subsection’’.
4 See References in Text note below.
3 So

1 So

in original. Probably should be ‘‘for’’.

§ 300x–33

§ 300x–34

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 1933 of act July 1, 1944, was classified
to section 300y–23 of this title and subsequently omitted from the Code.
AMENDMENTS
2000—Subsec. (b). Pub. L. 106–310 reenacted heading
without change and amended text generally. Prior to
amendment, text read as follows: ‘‘Each State’s allotment for fiscal year 2000 for programs under this subpart shall be equal to such State’s allotment for such
programs for fiscal year 1999, except that, if the
amount appropriated in fiscal year 2000 is less than the
amount appropriated in fiscal year 1999, then the
amount of a State’s allotment under section 300x–21 of
this title shall be equal to the amount that the State
received under section 300x–21 of this title in fiscal year
1999 decreased by the percentage by which the amount
appropriated for fiscal year 2000 is less than the amount
appropriated for such section for fiscal year 1999.’’
1999—Subsec. (b). Pub. L. 106–113 amended heading
and text of subsec. (b) generally. Prior to amendment,
text read as follows: ‘‘For each of the fiscal years 1993
and 1994, the amount of the allotment required in section 300x–21 of this title for a State for the fiscal year
involved shall be the greater of—
‘‘(1) the amount determined under subsection (a) of
this section for the State for the fiscal year; and
‘‘(2) an amount equal to 79.4 percent of the amount
received by the State from allotments made pursuant
to this part for fiscal year 1992 (including reallotments under section 205(a) of the ADAMHA Reorganization Act).’’
1998—Subsec. (b). Pub. L. 105–277, temporarily amended subsec. (b) to read as follows: ‘‘(b) MINIMUM ALLOTMENTS FOR STATES.—
‘‘(1) IN GENERAL.—With respect to fiscal year 1999,
the amount of the allotment of a State under section
300x–21 of this title shall not be less than the amount
the State received under section 300x–21 of this title
for fiscal year 1998 increased by 30.65 percent of the
percentage by which the amount allotted to the
States for fiscal year 1999 exceeds the amount allotted to the States for fiscal year 1998.
‘‘(2) LIMITATION
‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), a State shall not receive an allotment
under section 300x–21 of this title for fiscal year 1999
in an amount that is less than an amount equal to
0.375 percent of the amount appropriated under section 300x–35(a) of this title for such fiscal year.
‘‘(B) EXCEPTION.—In applying subparagraph (A),
the Secretary shall ensure that no State receives
an increase in its allotment under section 300x–21 of
this title for fiscal year 1999 (as compared to the
amount allotted to the State in the fiscal year 1998)
that is in excess of an amount equal to 300 percent
of the percentage by which the amount appropriated under section 300x–35(a) of this title for fiscal year 1999 exceeds the amount appropriated for
the prior fiscal year.
‘‘(3) Only for the purposes of calculating minimum
allotments under this subsection, any reference to
the amount appropriated under section 300x–35(a) of
this title for fiscal year 1998, allotments to States
under section 300x–21 of this title and any references
to amounts received by States in fiscal year 1998 shall
include amounts appropriated or received under the
amendments made by section 105 of the Contract with
America Advancement Act of 1996 (Public Law
104–121).’’
See Effective and Termination Dates of 1998 Amendment note below.
1992—Subsec. (c)(2)(C). Pub. L. 102–352 added subpar.
(C).
EFFECTIVE AND TERMINATION DATES OF 1998
AMENDMENT
Amendment by Pub. L. 105–277 effective as if enacted
on Oct. 1, 1998, and applicable only during fiscal year

Page 1120

1999, and upon expiration of fiscal year 1999, subsec. (b)
of this section, as in effect on Sept. 30, 1998, to be applied as if such amendment had not been enacted, see
section 101(f) [title II, § 218(c)] of Pub. L. 105–277, set out
as a note under section 300x–7 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.

§ 300x–34. Definitions
For purposes of this subpart:
(1) The term ‘‘authorized activities’’, subject
to section 300x–31 of this title, means the activities described in section 300x–21(b) of this
title.
(2) The term ‘‘funding agreement’’, with respect to a grant under section 300x–21 of this
title to a State, means that the Secretary may
make such a grant only if the State makes the
agreement involved.
(3) The term ‘‘prevention activities’’, subject
to section 300x–31 of this title, means activities to prevent substance abuse.
(4) The term ‘‘substance abuse’’ means the
abuse of alcohol or other drugs.
(5) The term ‘‘treatment activities’’ means
treatment services and, subject to section
300x–31 of this title, authorized activities that
are related to treatment services.
(6) The term ‘‘treatment facility’’ means an
entity that provides treatment services.
(7) The term ‘‘treatment services’’, subject
to section 300x–31 of this title, means treatment for substance abuse.
(July 1, 1944, ch. 373, title XIX, § 1934, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 402.)
PRIOR PROVISIONS
A prior section 1934 of act July 1, 1944, was classified
to section 300y–24 of this title and subsequently omitted from the Code.

§ 300x–35. Funding
(a) Authorization of appropriations
For the purpose of carrying out this subpart,
subpart III and section 290aa–4 of this title with
respect to substance abuse, and section
290bb–21(d) of this title, there are authorized to
be appropriated $2,000,000,000 for fiscal year 2001,
and such sums as may be necessary for each of
the fiscal years 2002 and 2003.
(b) Allocations for technical assistance, national
data base, data collection, and program evaluations
(1) In general
(A) For the purpose of carrying out section
300x–58(a) of this title with respect to substance abuse, section 290bb–21(d) of this title,
and the purposes specified in subparagraphs
(B) and (C), the Secretary shall obligate 5 percent of the amounts appropriated under subsection (a) of this section each fiscal year.
(B) The purpose specified in this subparagraph is the collection of data in this paragraph 1 is carrying out sections 290aa–4 and
1 So in original. The words ‘‘is the collection of data in this
paragraph’’ probably should not appear.

Page 1121

TITLE 42—THE PUBLIC HEALTH AND WELFARE

300y of this title with respect to substance
abuse.
(C) The purpose specified in this subparagraph is the conduct of evaluations of authorized activities to determine methods for improving the availability and quality of such
activities.
(2) Activities of Center for Substance Abuse
Prevention
Of the amounts reserved under paragraph (1)
for a fiscal year, the Secretary, acting through
the Director of the Center for Substance Abuse
Prevention, shall obligate 20 percent for carrying out paragraph (1)(C), section 300x–58(a) of
this title with respect to prevention activities,
and section 290bb–21(d) of this title.
(3) Core data set
A State that receives a new grant, contract,
or cooperative agreement from amounts available to the Secretary under paragraph (1), for
the purposes of improving the data collection,
analysis and reporting capabilities of the
State, shall be required, as a condition of receipt of funds, to collect, analyze, and report
to the Secretary for each fiscal year subsequent to receiving such funds a core data set
to be determined by the Secretary in conjunction with the States.
(July 1, 1944, ch. 373, title XIX, § 1935, as added
Pub. L. 102–321, title II, § 202, July 10, 1992, 106
Stat. 403; amended Pub. L. 106–310, div. B, title
XXXIII, § 3303(g), Oct. 17, 2000, 114 Stat. 1211.)
PRIOR PROVISIONS
A prior section 1935 of act July 1, 1944, was classified
to section 300y–25 of this title and subsequently omitted from the Code.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, § 3303(g)(1), substituted ‘‘$2,000,000,000 for fiscal year 2001, and such
sums as may be necessary for each of the fiscal years
2002 and 2003’’ for ‘‘$1,500,000,000 for fiscal year 1993, and
such sums as may be necessary for fiscal year 1994’’.
Subsec. (b)(1)(B). Pub. L. 106–310, § 3303(g)(2), substituted ‘‘sections 290aa–4 and 300y of this title’’ for
‘‘section 290aa–4 of this title’’.
Subsec. (b)(2). Pub. L. 106–310, § 3303(g)(3), made technical amendment to reference in original act which appears in text as reference to section 300x–58(a) of this
title.
Subsec. (b)(3). Pub. L. 106–310, § 3303(g)(4), added par.
(3).
SUBPART III—GENERAL PROVISIONS

§ 300x–51. Opportunity for public comment on
State plans
A funding agreement for a grant under section
300x or 300x–21 of this title is that the State involved will make the plan required in section
300x–1 of this title, and the plan required in section 300x–32 of this title, respectively, public
within the State in such manner as to facilitate
comment from any person (including any Federal or other public agency) during the development of the plan (including any revisions) and
after the submission of the plan to the Secretary.
(July 1, 1944, ch. 373, title XIX, § 1941, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 403.)

§ 300x–53

§ 300x–52. Requirement of reports and audits by
States
(a) Report
A funding agreement for a grant under section
300x or 300x–21 of this title is that the State involved will submit to the Secretary a report in
such form and containing such information as
the Secretary determines (after consultation
with the States) to be necessary for securing a
record and a description of—
(1) the purposes for which the grant received
by the State for the preceding fiscal year
under the program involved were expended and
a description of the activities of the State
under the program; and
(2) the recipients of amounts provided in the
grant.
(b) Audits
A funding agreement for a grant under section
300x or 300x–21 of this title is that the State will,
with respect to the grant, comply with chapter
75 of title 31.
(c) Availability to public
A funding agreement for a grant under section
300x or 300x–21 of this title is that the State involved will—
(1) make copies of the reports and audits described in this section available for public inspection within the State; and
(2) provide copies of the report under subsection (a) of this section, upon request, to
any interested person (including any public
agency).
(July 1, 1944, ch. 373, title XIX, § 1942, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 403; amended Pub. L. 104–316, title I,
§ 122(e), Oct. 19, 1996, 110 Stat. 3837.)
AMENDMENTS
1996—Subsec. (a). Pub. L. 104–316 struck out ‘‘and the
Comptroller General’’ after ‘‘with the States’’ in introductory provisions.

§ 300x–53. Additional requirements
(a) In general
A funding agreement for a grant under section
300x or 300x–21 of this title is that the State involved will—
(1)(A) for the fiscal year for which the grant
involved is provided, provide for independent
peer review to assess the quality, appropriateness, and efficacy of treatment services provided in the State to individuals under the
program involved; and
(B) ensure that, in the conduct of such peer
review, not fewer than 5 percent of the entities
providing services in the State under such program are reviewed (which 5 percent is representative of the total population of such entities);
(2) permit and cooperate with Federal investigations undertaken in accordance with section 300x–55 of this title; and
(3) provide to the Secretary any data required by the Secretary pursuant to section
290aa–4 of this title and will cooperate with
the Secretary in the development of uniform
criteria for the collection of data pursuant to
such section.

§ 300x–54

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Patient records
The Secretary may make a grant under section 300x or 300x–21 of this title only if the State
involved has in effect a system to protect from
inappropriate disclosure patient records maintained by the State in connection with an activity funded under the program involved or by any
entity which is receiving amounts from the
grant.
(July 1, 1944, ch. 373, title XIX, § 1943, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 404; amended Pub. L. 102–352, § 2(a)(12),
Aug. 26, 1992, 106 Stat. 939.)
AMENDMENTS
1992—Subsec. (a)(3). Pub. L. 102–352 substituted ‘‘section 290aa–4 of this title’’ for ‘‘section 290bb–21 of this
title’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.

§ 300x–54. Disposition of certain funds appropriated for allotments
(a) In general
Amounts described in subsection (b) of this
section and available for a fiscal year pursuant
to section 300x or 300x–21 of this title, as the
case may be, shall be allotted by the Secretary
and paid to the States receiving a grant under
the program involved, other than any State referred to in subsection (b) of this section with
respect to such program. Such amounts shall be
allotted in a manner equivalent to the manner
in which the allotment under the program involved was determined.
(b) Specification of amounts
The amounts referred to in subsection (a) of
this section are any amounts that—
(1) are not paid to States under the program
involved as a result of—
(A) the failure of any State to submit an
application in accordance with the program;
(B) the failure of any State to prepare such
application in compliance with the program;
or
(C) any State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State
under the program;
(2) are terminated, repaid, or offset under
section 300x–55 of this title;
(3) in the case of the program established in
section 300x of this title, are available as a result of reductions in allotments under such
section pursuant to section 300x–1(d) or
300x–4(b) of this title; or
(4) in the case of the program established in
section 300x–21 of this title, are available as a
result of reductions in allotments under such
section pursuant to section 300x–26 or 300x–30
of this title.
(July 1, 1944, ch. 373, title XIX, § 1944, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 404.)

Page 1122

§ 300x–55. Failure to comply with agreements
(a) Suspension or termination of payments
Subject to subsection (e) of this section, if the
Secretary determines that a State has materially failed to comply with the agreements or
other conditions required for the receipt of a
grant under the program involved, the Secretary
may in whole or in part suspend payments under
the grant, terminate the grant for cause, or employ such other remedies (including the remedies provided for in subsections (b) and (c) of
this section) as may be legally available and appropriate in the circumstances involved.
(b) Repayment of payments
(1) In general
Subject to subsection (e) of this section, the
Secretary may require a State to repay with
interest any payments received by the State
under section 300x or 300x–21 of this title that
the Secretary determines were not expended
by the State in accordance with the agreements required under the program involved.
(2) Offset against payments
If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against the
amount of any payment due to be paid to the
State under the program involved.
(c) Withholding of payments
(1) In general
Subject to subsections (e) and (g)(3) of this
section, the Secretary may withhold payments
due under section 300x or 300x–21 of this title
if the Secretary determines that the State involved is not expending amounts received
under the program involved in accordance
with the agreements required under the program.
(2) Termination of withholding
The Secretary shall cease withholding payments from a State under paragraph (1) if the
Secretary determines that there are reasonable assurances that the State will expend
amounts received under the program involved
in accordance with the agreements required
under the program.
(d) Applicability of remedies to certain violations
(1) In general
With respect to agreements or other conditions for receiving a grant under the program
involved, in the case of the failure of a State
to maintain material compliance with a condition referred to in paragraph (2), the provisions for noncompliance with the condition
that are provided in the section establishing
the condition shall apply in lieu of subsections
(a) through (c) of this section.
(2) Relevant conditions
For purposes of paragraph (1):
(A) In the case of the program established
in section 300x of this title, a condition referred to in this paragraph is the condition
established in section 300x–1(d) of this title
and the condition established in section
300x–4(b) of this title.

Page 1123

§ 300x–57

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) In the case of the program established
in section 300x–21 of this title, a condition
referred to in this paragraph is the condition
established in section 300x–26 of this title
and the condition established in section
300x–30 of this title.
(e) Opportunity for hearing
Before taking action against a State under
any of subsections (a) through (c) of this section
(or under a section referred to in subsection
(d)(2) of this section, as the case may be), the
Secretary shall provide to the State involved
adequate notice and an opportunity for a hearing.
(f) Requirement of hearing in certain circumstances
(1) In general
If the Secretary receives a complaint that a
State has failed to maintain material compliance with the agreements or other conditions
required for receiving a grant under the program involved (including any condition referred to for purposes of subsection (d) of this
section), and there appears to be reasonable
evidence to support the complaint, the Secretary shall promptly conduct a hearing with
respect to the complaint.
(2) Finding of material noncompliance
If in a hearing under paragraph (1) the Secretary finds that the State involved has failed
to maintain material compliance with the
agreement or other condition involved, the
Secretary shall take such action under this
section as may be appropriate to ensure that
material compliance is so maintained, or such
action as may be required in a section referred
to in subsection (d)(2) of this section, as the
case may be.
(g) Certain investigations
(1) Requirement regarding Secretary
The Secretary shall in fiscal year 1994 and
each subsequent fiscal year conduct in not less
than 10 States investigations of the expenditure of grants received by the States under
section 300x or 300x–21 of this title in order to
evaluate compliance with the agreements required under the program involved.
(2) Provision of records, etc., upon request
Each State receiving a grant under section
300x or 300x–21 of this title, and each entity receiving funds from the grant, shall make appropriate books, documents, papers, and
records available to the Secretary or the
Comptroller General, or any of their duly authorized representatives, for examination,
copying, or mechanical reproduction on or off
the premises of the appropriate entity upon a
reasonable request therefor.
(3) Limitations on authority
The Secretary may not institute proceedings
under subsection (c) of this section unless the
Secretary has conducted an investigation concerning whether the State has expended payments under the program involved in accordance with the agreements required under the
program. Any such investigation shall be con-

ducted within the State by qualified investigators.
(July 1, 1944, ch. 373, title XIX, § 1945, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 405.)
§ 300x–56.
funds

Prohibitions

regarding

receipt

of

(a) Establishment
(1) Certain false statements and representations
A person shall not knowingly and willfully
make or cause to be made any false statement
or representation of a material fact in connection with the furnishing of items or services
for which payments may be made by a State
from a grant made to the State under section
300x or 300x–21 of this title.
(2) Concealing or failing to disclose certain
events
A person with knowledge of the occurrence
of any event affecting the initial or continued
right of the person to receive any payments
from a grant made to a State under section
300x or 300x–21 of this title shall not conceal or
fail to disclose any such event with an intent
fraudulently to secure such payment either in
a greater amount than is due or when no such
amount is due.
(b) Criminal penalty for violation of prohibition
Any person who violates any prohibition established in subsection (a) of this section shall
for each violation be fined in accordance with
title 18 or imprisoned for not more than 5 years,
or both.
(July 1, 1944, ch. 373, title XIX, § 1946, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 406.)
§ 300x–57. Nondiscrimination
(a) In general
(1) Rule of construction regarding certain civil
rights laws
For the purpose of applying the prohibitions
against discrimination on the basis of age
under the Age Discrimination Act of 1975 [42
U.S.C. 6101 et seq.], on the basis of handicap
under section 504 of the Rehabilitation Act of
1973 [29 U.S.C. 794], on the basis of sex under
title IX of the Education Amendments of 1972
[20 U.S.C. 1681 et seq.], or on the basis of race,
color, or national origin under title VI of the
Civil Rights Act of 1964 [42 U.S.C. 2000d et
seq.], programs and activities funded in whole
or in part with funds made available under
section 300x or 300x–21 of this title shall be
considered to be programs and activities receiving Federal financial assistance.
(2) Prohibition
No person shall on the ground of sex (including, in the case of a woman, on the ground
that the woman is pregnant), or on the ground
of religion, be excluded from participation in,
be denied the benefits of, or be subjected to
discrimination under, any program or activity
funded in whole or in part with funds made

§ 300x–58

TITLE 42—THE PUBLIC HEALTH AND WELFARE

available under section 300x or 300x–21 of this
title.
(b) Enforcement
(1) Referrals to Attorney General after notice
Whenever the Secretary finds that a State,
or an entity that has received a payment pursuant to section 300x or 300x–21 of this title,
has failed to comply with a provision of law
referred to in subsection (a)(1) of this section,
with subsection (a)(2) of this section, or with
an applicable regulation (including one prescribed to carry out subsection (a)(2) of this
section), the Secretary shall notify the chief
executive officer of the State and shall request
the chief executive officer to secure compliance. If within a reasonable period of time, not
to exceed 60 days, the chief executive officer
fails or refuses to secure compliance, the Secretary may—
(A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be instituted;
(B) exercise the powers and functions provided by the Age Discrimination Act of 1975
[42 U.S.C. 6101 et seq.], section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], title
IX of the Education Amendments of 1972 [20
U.S.C. 1681 et seq.], or title VI of the Civil
Rights Act of 1964 [42 U.S.C. 2000d et seq.], as
may be applicable; or
(C) take such other actions as may be authorized by law.
(2) Authority of Attorney General
When a matter is referred to the Attorney
General pursuant to paragraph (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
pattern or practice in violation of a provision
of law referred to in subsection (a)(1) of this
section or in violation of subsection (a)(2) of
this section, the Attorney General may bring
a civil action in any appropriate district court
of the United States for such relief as may be
appropriate, including injunctive relief.
(July 1, 1944, ch. 373, title XIX, § 1947, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 407.)
REFERENCES IN TEXT
The Age Discrimination Act of 1975, referred to in
subsecs. (a)(1) and (b)(1)(B), is title III of Pub. L. 94–135,
Nov. 28, 1975, 89 Stat. 728, as amended, which is classified generally to chapter 76 (§ 6101 et seq.) of this title.
For complete classification of this Act to the Code, see
Short Title note set out under section 6101 of this title
and Tables.
The Education Amendments of 1972, referred to in
subsecs. (a)(1) and (b)(1)(B), is Pub. L. 92–318, June 23,
1972, 86 Stat. 235, as amended. Title IX of the Act,
known as the Patsy Takemoto Mink Equal Opportunity
in Education Act, is classified principally to chapter 38
(§ 1681 et seq.) of Title 20, Education. For complete classification of title IX to the Code, see Short Title note
set out under section 1681 of Title 20 and Tables.
The Civil Rights Act of 1964, referred to in subsecs.
(a)(1) and (b)(1)(B), is Pub. L. 88–352, July 2, 1964, 78
Stat. 241, as amended. Title VI of the Act is classified
generally to subchapter V (§ 2000d et seq.) of chapter 21
of this title. For complete classification of this Act to
the Code, see Short Title note set out under section
2000a of this title and Tables.

Page 1124

§ 300x–58. Technical assistance and provision of
supplies and services in lieu of grant funds
(a) Technical assistance
The Secretary shall, without charge to a State
receiving a grant under section 300x or 300x–21 of
this title, provide to the State (or to any public
or nonprofit private entity within the State)
technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to the program involved. The Secretary may provide such
technical assistance directly, through contract,
or through grants.
(b) Provision of supplies and services in lieu of
grant funds
(1) In general
Upon the request of a State receiving a
grant under section 300x or 300x–21 of this
title, the Secretary may, subject to paragraph
(2), provide supplies, equipment, and services
for the purpose of aiding the State in carrying
out the program involved and, for such purpose, may detail to the State any officer or
employee of the Department of Health and
Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the
amount of payments under the program involved to the State by an amount equal to the
costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary
shall, for the payment of expenses incurred in
complying with such request, expend the
amounts withheld.
(July 1, 1944, ch. 373, title XIX, § 1948, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 408.)
§ 300x–59. Plans for performance partnerships
(a) Development
The Secretary in conjunction with States and
other interested groups shall develop separate
plans for the programs authorized under subparts I and II for creating more flexibility for
States and accountability based on outcome and
other performance measures. The plans shall
each include—
(1) a description of the flexibility that would
be given to the States under the plan;
(2) the common set of performance measures
that would be used for accountability, including measures that would be used for the program under subpart II for pregnant addicts,
HIV transmission, tuberculosis, and those
with a co-occurring substance abuse and mental disorders, and for programs under subpart
I for children with serious emotional disturbance and adults with serious mental illness
and for individuals with co-occurring mental
health and substance abuse disorders;
(3) the definitions for the data elements to
be used under the plan;
(4) the obstacles to implementation of the
plan and the manner in which such obstacles
would be resolved;

Page 1125

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) the resources needed to implement the
performance partnerships under the plan; and
(6) an implementation strategy complete
with recommendations for any necessary legislation.
(b) Submission
Not later than 2 years after October 17, 2000,
the plans developed under subsection (a) of this
section shall be submitted to the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Commerce of the
House of Representatives.
(c) Information
As the elements of the plans described in subsection (a) of this section are developed, States
are encouraged to provide information to the
Secretary on a voluntary basis.
(d) Participants
The Secretary shall include among those interested groups that participate in the development of the plan consumers of mental health or
substance abuse services, providers, representatives of political divisions of States, and representatives of racial and ethnic groups including Native Americans.
(July 1, 1944, ch. 373, title XIX, § 1949, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 408; amended Pub. L. 106–310, div. B, title
XXXIV, § 3403(a), Oct. 17, 2000, 114 Stat. 1219.)
CODIFICATION
October 17, 2000, referred to in subsec. (b), was in the
original ‘‘the date of the enactment of this Act’’, which
was translated as meaning the date of enactment of
Pub. L. 106–310, which amended this section generally,
to reflect the probable intent of Congress.
AMENDMENTS
2000—Pub. L. 106–310 amended section catchline and
text generally. Prior to amendment, text read as follows: ‘‘Not later than January 24, 1994, the Secretary
shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate,
a report on the activities of the States carried out pursuant to the programs established in sections 300x and
300x–21 of this title. Such report may include any recommendations of the Secretary for appropriate changes
in legislation.’’
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.

§ 300x–60. Rule of construction regarding delegation of authority to States
With respect to States receiving grants under
section 300x or 300x–21 of this title, this part
may not be construed to authorize the Secretary
to delegate to the States the primary responsibility for interpreting the governing provisions of this part.
(July 1, 1944, ch. 373, title XIX, § 1950, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 408.)

§ 300x–63

§ 300x–61. Solicitation of views of certain entities
In carrying out this part, the Secretary, as appropriate, shall solicit the views of the States
and other appropriate entities.
(July 1, 1944, ch. 373, title XIX, § 1951, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 408.)
§ 300x–62. Availability to States of grant payments
Any amounts paid to a State for a fiscal year
under section 300x or 300x–21 of this title shall be
available for obligation and expenditure until
the end of the fiscal year following the fiscal
year for which the amounts were paid.
(July 1, 1944, ch. 373, title XIX, § 1952, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 409; amended Pub. L. 106–310, div. B, title
XXXIV, § 3403(b), Oct. 17, 2000, 114 Stat. 1220.)
AMENDMENTS
2000—Pub. L. 106–310 reenacted section catchline
without change and amended text generally. Prior to
amendment, text read as follows:
‘‘(a) IN GENERAL.—Subject to subsection (b) of this
section, any amounts paid to a State under the program involved shall be available for obligation until
the end of the fiscal year for which the amounts were
paid, and if obligated by the end of such year, shall remain available for expenditure until the end of the succeeding fiscal year.
‘‘(b) EXCEPTION REGARDING NONCOMPLIANCE OF SUBGRANTEES.—If a State has in accordance with subsection (a) of this section obligated amounts paid to
the State under the program involved, in any case in
which the Secretary determines that the obligation
consists of a grant or contract awarded by the State,
and that the State has terminated or reduced the
amount of such financial assistance on the basis of the
failure of the recipient of the assistance to comply with
the terms upon which the assistance was conditioned—
‘‘(1) the amounts involved shall be available for reobligation by the State through September 30 of the
fiscal year following the fiscal year for which the
amounts were paid to the State; and
‘‘(2) any of such amounts that are obligated by the
State in accordance with paragraph (1) shall be available for expenditure through such date.’’

§ 300x–63. Continuation of certain programs
(a) In general
Of the amount allotted to the State of Hawaii
under section 300x of this title, and the amount
allotted to such State under section 300x–21 of
this title, an amount equal to the proportion of
Native Hawaiians residing in the State to the
total population of the State shall be available,
respectively, for carrying out the program involved for Native Hawaiians.
(b) Expenditure of amounts
The amount made available under subsection
(a) of this section may be expended only through
contracts entered into by the State of Hawaii
with public and private nonprofit organizations
to enable such organizations to plan, conduct,
and administer comprehensive substance abuse
and treatment programs for the benefit of Native Hawaiians. In entering into contracts under
this section, the State of Hawaii shall give preference to Native Hawaiian organizations and
Native Hawaiian health centers.

§ 300x–64

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Definitions
For the purposes of this subsection,1 the terms
‘‘Native Hawaiian’’, ‘‘Native Hawaiian organization’’, and ‘‘Native Hawaiian health center’’
have the meaning given such terms in section
11707 of this title.
(July 1, 1944, ch. 373, title XIX, § 1953, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 409.)
§ 300x–64. Definitions
(a) Definitions for this subpart
For purposes of this subpart:
(1) The term ‘‘program involved’’ means the
program of grants established in section 300x
or 300x–21 of this title, or both, as indicated by
whether the State involved is receiving or is
applying to receive a grant under section 300x
or 300x–21 of this title, or both.
(2)(A) The term ‘‘funding agreement’’, with
respect to a grant under section 300x of this
title, has the meaning given such term in section 300x–8 of this title.
(B) The term ‘‘funding agreement’’, with respect to a grant under section 300x–21 of this
title, has the meaning given such term in section 300x–34 of this title.
(b) Definitions for this part
For purposes of this part:
(1) The term ‘‘Comptroller General’’ means
the Comptroller General of the United States.
(2) The term ‘‘State’’, except as provided in
sections 300x–7(c)(5) of this title and
300x–33(c)(5) of this title, means each of the
several States, the District of Columbia, and
each of the territories of the United States.
(3) The term ‘‘territories of the United
States’’ means each of the Commonwealth of
Puerto Rico, American Samoa, Guam, the
Commonwealth of the Northern Mariana Islands, the Virgin Islands, Palau, the Marshall
Islands, and Micronesia.
(4) The term ‘‘interim services’’, in the case
of an individual in need of treatment for substance abuse who has been denied admission to
a program of such treatment on the basis of
the lack of the capacity of the program to
admit the individual, means services for reducing the adverse health effects of such
abuse, for promoting the health of the individual, and for reducing the risk of transmission
of disease, which services are provided until
the individual is admitted to such a program.
(July 1, 1944, ch. 373, title XIX, § 1954, as added
Pub. L. 102–321, title II, § 203(a), July 10, 1992, 106
Stat. 409.)
§ 300x–65. Services provided by nongovernmental
organizations
(a) Purposes
The purposes of this section are—
(1) to prohibit discrimination against nongovernmental organizations and certain individuals on the basis of religion in the distribution of government funds to provide substance
abuse services under this subchapter and sub1 So

in original. Probably should be ‘‘section,’’.

Page 1126

chapter III–A of this chapter, and the receipt
of services under such subchapters; and
(2) to allow the organizations to accept the
funds to provide the services to the individuals
without impairing the religious character of
the organizations or the religious freedom of
the individuals.
(b) Religious organizations included as nongovernmental providers
(1) In general
A State may administer and provide substance abuse services under any program
under this subchapter or subchapter III–A of
this chapter through grants, contracts, or cooperative agreements to provide assistance to
beneficiaries under such subchapters with nongovernmental organizations.
(2) Requirement
A State that elects to utilize nongovernmental organizations as provided for under
paragraph (1) shall consider, on the same basis
as other nongovernmental organizations, religious organizations to provide services under
substance abuse programs under this subchapter or subchapter III–A of this chapter, so
long as the programs under such subchapters
are implemented in a manner consistent with
the Establishment Clause of the first amendment to the Constitution. Neither the Federal
Government nor a State or local government
receiving funds under such programs shall discriminate against an organization that provides services under, or applies to provide
services under, such programs, on the basis
that the organization has a religious character.
(c) Religious character and independence
(1) In general
A religious organization that provides services under any substance abuse program under
this subchapter or subchapter III–A of this
chapter shall retain its independence from
Federal, State, and local governments, including such organization’s control over the definition, development, practice, and expression
of its religious beliefs.
(2) Additional safeguards
Neither the Federal Government nor a State
or local government shall require a religious
organization—
(A) to alter its form of internal governance; or
(B) to remove religious art, icons, scripture, or other symbols,
in order to be eligible to provide services
under any substance abuse program under this
subchapter or subchapter III–A of this chapter.
(d) Employment practices
(1) Substance abuse
A religious organization that provides services under any substance abuse program under
this subchapter or subchapter III–A of this
chapter may require that its employees providing services under such program adhere to
rules forbidding the use of drugs or alcohol.
(2) Title VII exemption
The exemption of a religious organization
provided under section 702 or 703(e)(2) of the

Page 1127

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Civil Rights Act of 1964 (42 U.S.C. 2000e–1,
2000e–2(e)(2)) regarding employment practices
shall not be affected by the religious organization’s provision of services under, or receipt of
funds from, any substance abuse program
under this subchapter or subchapter III–A of
this chapter.
(e) Rights of beneficiaries of assistance
(1) In general
If an individual described in paragraph (3)
has an objection to the religious character of
the organization from which the individual receives, or would receive, services funded under
any substance abuse program under this subchapter or subchapter III–A of this chapter,
the appropriate Federal, State, or local governmental entity shall provide to such individual (if otherwise eligible for such services)
within a reasonable period of time after the
date of such objection, services that—
(A) are from an alternative provider that
is accessible to the individual; and
(B) have a value that is not less than the
value of the services that the individual
would have received from such organization.
(2) Notice
The appropriate Federal, State, or local governmental entity shall ensure that notice is
provided to individuals described in paragraph
(3) of the rights of such individuals under this
section.
(3) Individual described
An individual described in this paragraph is
an individual who receives or applies for services under any substance abuse program under
this subchapter or subchapter III–A of this
chapter.
(f) Nondiscrimination against beneficiaries
A religious organization providing services
through a grant, contract, or cooperative agreement under any substance abuse program under
this subchapter or subchapter III–A of this chapter shall not discriminate, in carrying out such
program, against an individual described in subsection (e)(3) of this section on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate
in a religious practice.
(g) Fiscal accountability
(1) In general
Except as provided in paragraph (2), any religious organization providing services under
any substance abuse program under this subchapter or subchapter III–A of this chapter
shall be subject to the same regulations as
other nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such funds
provided under such program.
(2) Limited audit
Such organization shall segregate government funds provided under such substance
abuse program into a separate account. Only
the government funds shall be subject to audit
by the government.
(h) Compliance
Any party that seeks to enforce such party’s
rights under this section may assert a civil ac-

§ 300x–66

tion for injunctive relief exclusively in an appropriate Federal or State court against the entity, agency or official that allegedly commits
such violation.
(i) Limitations on use of funds for certain purposes
No funds provided through a grant or contract
to a religious organization to provide services
under any substance abuse program under this
subchapter or subchapter III–A of this chapter
shall be expended for sectarian worship, instruction, or proselytization.
(j) Effect on State and local funds
If a State or local government contributes
State or local funds to carry out any substance
abuse program under this subchapter or subchapter III–A of this chapter, the State or local
government may segregate the State or local
funds from the Federal funds provided to carry
out the program or may commingle the State or
local funds with the Federal funds. If the State
or local government commingles the State or
local funds, the provisions of this section shall
apply to the commingled funds in the same manner, and to the same extent, as the provisions
apply to the Federal funds.
(k) Treatment of intermediate contractors
If a nongovernmental organization (referred to
in this subsection as an ‘‘intermediate organization’’), acting under a contract or other agreement with the Federal Government or a State or
local government, is given the authority under
the contract or agreement to select nongovernmental organizations to provide services under
any substance abuse program under this subchapter or subchapter III–A of this chapter, the
intermediate organization shall have the same
duties under this section as the government but
shall retain all other rights of a nongovernmental organization under this section.
(July 1, 1944, ch. 373, title XIX, § 1955, as added
Pub. L. 106–310, div. B, title XXXIII, § 3305, Oct.
17, 2000, 114 Stat. 1212.)
§ 300x–66. Services for individuals with co-occurring disorders
States may use funds available for treatment
under sections 300x and 300x–21 of this title to
treat persons with co-occurring substance abuse
and mental disorders as long as funds available
under such sections are used for the purposes for
which they were authorized by law and can be
tracked for accounting purposes.
(July 1, 1944, ch. 373, title XIX, § 1956, as added
Pub. L. 106–310, div. B, title XXXIV, § 3407, Oct.
17, 2000, 114 Stat. 1222.)
PART C—CERTAIN PROGRAMS REGARDING
MENTAL HEALTH AND SUBSTANCE ABUSE
AMENDMENTS
2000—Pub. L. 106–310, div. B, title XXXIV, § 3404(1),
Oct. 17, 2000, 114 Stat. 1220, added part C heading and
struck out former part C heading ‘‘Certain Programs
Regarding Substance Abuse’’.
SUBPART I—DATA INFRASTRUCTURE DEVELOPMENT

AMENDMENTS
2000—Pub. L. 106–310, div. B, title XXXIV, § 3404(1),
Oct. 17, 2000, 114 Stat. 1220, added subpart I heading and

§ 300y

TITLE 42—THE PUBLIC HEALTH AND WELFARE

struck out former subpart I heading ‘‘Expansion of Capacity for Providing Treatment’’.

§ 300y. Data infrastructure development
(a) In general
The Secretary may make grants to, and enter
into contracts or cooperative agreements with
States for the purpose of developing and operating mental health or substance abuse data collection, analysis, and reporting systems with regard to performance measures including capacity, process, and outcomes measures.
(b) Projects
The Secretary shall establish criteria to ensure that services will be available under this
section to States that have a fundamental basis
for the collection, analysis, and reporting of
mental health and substance abuse performance
measures and States that do not have such
basis. The Secretary will establish criteria for
determining whether a State has a fundamental
basis for the collection, analysis, and reporting
of data.
(c) Condition of receipt of funds
As a condition of the receipt of an award under
this section a State shall agree to collect, analyze, and report to the Secretary within 2 years
of the date of the award on a core set of performance measures to be determined by the Secretary in conjunction with the States.
(d) Matching requirement
(1) In general
With respect to the costs of the program to
be carried out under subsection (a) of this section by a State, the Secretary may make an
award under such subsection only if the applicant agrees to make available (directly or
through donations from public or private entities) non-Federal contributions toward such
costs in an amount that is not less than 50 percent of such costs.
(2) Determination of amount contributed
Non-Federal contributions under paragraph
(1) may be in cash or in kind, fairly evaluated,
including plant, equipment, or services.
Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the
amount of such contributions.
(e) Duration of support
The period during which payments may be
made for a project under subsection (a) of this
section may be not less than 3 years nor more
than 5 years.
(f) Authorization of appropriation
(1) In general
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2001, 2002 and 2003.
(2) Allocation
Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall be
expended to support data infrastructure devel-

Page 1128

opment for mental health and 50 percent shall
be expended to support data infrastructure development for substance abuse.
(July 1, 1944, ch. 373, title XIX, § 1971, as added
Pub. L. 106–310, div. B, title XXXIV, § 3404(2),
Oct. 17, 2000, 114 Stat. 1220.)
PRIOR PROVISIONS
A prior section 300y, act July 1, 1944, ch. 373, title
XIX, § 1971, as added Pub. L. 102–321, title II, § 204, July
10, 1992, 106 Stat. 410; amended Pub. L. 102–352, § 2(a)(13),
Aug. 26, 1992, 106 Stat. 939, related to categorical grants
to States for programs regarding substance abuse, prior
to repeal by Pub. L. 106–310, div. B, title XXXIV,
§ 3404(2), Oct. 17, 2000, 114 Stat. 1220.
Another prior section 300y, act July 1, 1944, ch. 373,
title XIX, § 1921, as added Oct. 27, 1986, Pub. L. 99–570,
title IV, § 4002, 100 Stat. 3207–103, related to establishment of special alcohol abuse and drug abuse programs,
prior to repeal by Pub. L. 100–690, title II, § 2038(1), Nov.
18, 1988, 102 Stat. 4203.
Another prior section 300y, act July 1, 1944, ch. 373,
title XIX, § 1921, as added Aug. 13, 1981, Pub. L. 97–35,
title IX, § 901, 95 Stat. 552, related to planning grants,
prior to repeal by Pub. L. 99–280, § 5, Apr. 24, 1986, 100
Stat. 400.
Prior sections 300y–1 and 300y–2 were repealed by Pub.
L. 100–690, title II, § 2038(1), Nov. 18, 1988, 102 Stat. 4203.
Section 300y–1, act July 1, 1944, ch. 373, title XIX,
§ 1922, as added Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4002, 100 Stat. 3207–106, related to transfer of funds to
Administrator of Veterans’ Affairs.
Another prior section 300y–1, act July 1, 1944, ch. 373,
title XIX, § 1922, as added Aug. 13, 1981, Pub. L. 97–35,
title IX, § 901, 95 Stat. 552, authorized appropriations,
prior to repeal by Pub. L. 99–280, § 5, Apr. 24, 1986, 100
Stat. 400.
Section 300y–2, act July 1, 1944, ch. 373, title XIX,
§ 1923, as added Oct. 27, 1986, Pub. L. 99–570, title IV,
§ 4002, 100 Stat. 3207–106, related to evaluation of treatment programs.
Another prior section 300y–2, act July 1, 1944, ch. 373,
title XIX, § 1923, as added Aug. 13, 1981, Pub. L. 97–35,
title IX, § 901, 95 Stat. 552, provided for grants under
section 254c of this title, prior to repeal by Pub. L.
99–280, § 5, Apr. 24, 1986, 100 Stat. 400.
Prior sections 300y–3 to 300y–10 were repealed by Pub.
L. 99–280, § 5, Apr. 24, 1986, 100 Stat. 400.
Section 300y–3, act July 1, 1944, ch. 373, title XIX,
§ 1924, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 553, provided that allotments be based upon
prior year distributions and provided for direct distributions to Indian tribes.
Section 300y–4, act July 1, 1944, ch. 373, title XIX,
§ 1925, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 553, related to payments under allotments to
States.
Section 300y–5, act July 1, 1944, ch. 373, title XIX,
§ 1926, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 554, related to State grants to community
health centers from allotments.
Section 300y–6, act July 1, 1944, ch. 373, title XIX,
§ 1927, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 556, related to application requirements and
submittal, availability for public comment, and revision of a description of intended use of funds.
Section 300y–7, act July 1, 1944, ch. 373, title XIX,
§ 1928, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 557, related to reporting and auditing requirements.
Section 300y–8, act July 1, 1944, ch. 373, title XIX,
§ 1929, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 558, related to withholding of funds from a
State not in compliance.
Section 300y–9, act July 1, 1944, ch. 373, title XIX,
§ 1930, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 558, related to nondiscrimination requirements.
Section 300y–10, act July 1, 1944, ch. 373, title XIX,
§ 1931, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,

Page 1129

TITLE 42—THE PUBLIC HEALTH AND WELFARE

95 Stat. 559, provided criminal penalty for false statements.
SUBPART II—INTERIM MAINTENANCE TREATMENT
OF NARCOTICS DEPENDENCE

§ 300y–11. Interim maintenance treatment
(a) Requirement regarding Secretary
Subject to the following subsections of this
section, for the purpose of reducing the incidence of the transmission of HIV disease pursuant to the intravenous abuse of heroin or other
morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or nonprofit private programs of treatment
for dependence on such drugs, shall authorize
such programs—
(1) to dispense methadone for treatment purposes to individuals who—
(A) meet the conditions for admission to
such programs that dispense methadone as
part of comprehensive treatment for such
dependence; and
(B) are seeking admission to such programs that so dispense methadone, but as a
result of the limited capacity of the programs, will not gain such admission until 14
or more days after seeking admission to the
programs; and
(2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in which the individuals
are waiting for admission to programs of comprehensive treatment.
(b) Inapplicability of requirement in certain circumstances
(1) In general
The requirement established in subsection
(a) of this section for the Secretary does not
apply if any or all of the following conditions
are met:
(A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease pursuant to the intravenous abuse of drugs is minimal.
(B) The preponderance of scientific research indicates that the medically supervised dispensing of methadone is not an effective method of reducing the extent of dependence on heroin and other morphine-like
drugs.
(C) The preponderance of available data indicates that, of treatment programs that
dispense methadone as part of comprehensive treatment, a substantial majority
admit all individuals seeking services to the
programs not later than 14 days after the individuals seek admission to the programs.
(2) Evaluation by Secretary
In evaluating whether any or all of the conditions described in paragraph (1) have been
met, the Secretary shall consult with the National Commission on Acquired Immune Deficiency Syndrome.
(c) Conditions for obtaining authorization from
Secretary
(1) In general
In carrying out the requirement established
in subsection (a) of this section, the Secretary

§ 300y–11

shall, after consultation with the National
Commission on Acquired Immune Deficiency
Syndrome, by regulation issue such conditions
for treatment programs to obtain authorization from the Secretary to provide interim
maintenance treatment as may be necessary
to carry out the purpose described in such subsection. Such conditions shall include conditions for preventing the unauthorized use of
methadone.
(2) Counseling on HIV disease
The regulations issued under paragraph (1)
shall provide that an authorization described
in such paragraph may not be issued to a
treatment program unless the program provides to recipients of the treatment counseling
on preventing exposure to and the transmission of HIV disease.
(3) Permission of relevant State as condition of
authorization
The regulations issued under paragraph (1)
shall provide that the Secretary may not provide an authorization described in such paragraph to any treatment program in a State
unless the chief public health officer of the
State has certified to the Secretary that—
(A) such officer does not object to the provision of such authorizations to treatment
programs in the State; and
(B) the provision of interim maintenance
services in the State will not reduce the capacity of comprehensive treatment programs in the State to admit individuals to
the programs (relative to the date on which
such officer so certifies).
(4) Date certain for issuance of regulations;
failure of Secretary
The Secretary shall issue the final rule for
purposes of the regulations required in paragraph (1), and such rule shall be effective, not
later than the expiration of the 180-day period
beginning on July 10, 1992. If the Secretary
fails to meet the requirement of the preceding
sentence, the proposed rule issued on March 2,
1989, with respect to part 291 of title 21, Code
of Federal Regulations (docket numbered
88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to
take effect as a final rule upon the expiration
of such period, and the provisions of paragraph
(3) of this subsection are deemed to be incorporated into such rule.
(d) Definitions
For purposes of this section:
(1) The term ‘‘interim maintenance services’’ means the provision of methadone in a
treatment program under the circumstances
described in paragraphs (1) and (2) of subsection (a) of this section.
(2) The term ‘‘HIV disease’’ means infection
with the etiologic agent for acquired immune
deficiency syndrome.
(3) The term ‘‘treatment program’’ means a
public or nonprofit private program of treatment for dependence on heroin or other morphine-like drugs.
(July 1, 1944, ch. 373, title XIX, § 1976, as added
Pub. L. 102–321, title II, § 204, July 10, 1992, 106
Stat. 412.)

§ 300z

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 300y–11, act July 1, 1944, ch. 373, title
XIX, § 1932, as added Aug. 13, 1981, Pub. L. 97–35, title IX,
§ 901, 95 Stat. 559; amended Jan. 4, 1983, Pub. L. 97–414,
§ 8(v), 96 Stat. 2063, related to applicability of other provisions and promulgation of regulations, prior to repeal
by Pub. L. 99–280, § 5, Apr. 24, 1986, 100 Stat. 400.
Sections 300y–21 to 300y–27 terminated Jan. 1, 1991,
pursuant to section 300y–27 and were omitted from the
Code.
Section 300y–21, act July 1, 1944, ch. 373, title XIX,
§ 1931, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3117, provided definitions for this part.
A prior section 1931 of act July 1, 1944, ch. 373, title
XIX, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 559, provided criminal penalty for false statements and was classified to former section 300y–10 of
this title, prior to repeal by Pub. L. 99–280, § 5, Apr. 24,
1986, 100 Stat. 400.
Section 300y–22, act July 1, 1944, ch. 373, title XIX,
§ 1932, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3117, authorized appropriations for
this part.
A prior section 1932 of act July 1, 1944, ch. 373, title
XIX, as added Aug. 13, 1981, Pub. L. 97–35, title IX, § 901,
95 Stat. 559; amended Jan. 4, 1983, Pub. L. 97–414, § 8(v),
96 Stat. 2063, related to applicability of other provisions
and promulgation of regulations and was classified to
former section 300y–11 of this title, prior to repeal by
Pub. L. 99–280, § 5, Apr. 24, 1986, 100 Stat. 400.
Section 300y–23, act July 1, 1944, ch. 373, title XIX,
§ 1933, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3117, provided for allotments under
this part.
Section 300y–24, act July 1, 1944, ch. 373, title XIX,
§ 1934, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3118, provided for payments under allotments to States.
Section 300y–25, act July 1, 1944, ch. 373, title XIX,
§ 1935, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3118, specified use of allotments.
Section 300y–26, act July 1, 1944, ch. 373, title XIX,
§ 1936, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3119, provided for applications, requirements of the application, and description of activities.
Section 300y–27, act July 1, 1944, ch. 373, title XIX,
§ 1937, as added Nov. 4, 1988, Pub. L. 100–607, title IV,
§ 408(a), 102 Stat. 3120; amended Aug. 16, 1989, Pub. L.
101–93, § 5(f)(1)(B), 103 Stat. 612, provided for termination of this part effective Jan. 1, 1991.
EFFECTIVE DATE
Section effective July 10, 1992, with programs making
awards providing financial assistance in fiscal year 1993
and subsequent years effective for awards made on or
after Oct. 1, 1992, see section 801(b), (d)(1) of Pub. L.
102–321, set out as an Effective Date of 1992 Amendment
note under section 236 of this title.

SUBCHAPTER XVIII—ADOLESCENT FAMILY
LIFE DEMONSTRATION PROJECTS
§ 300z. Findings and purposes
(a) The Congress finds that—
(1) in 1978, an estimated one million one hundred thousand teenagers became pregnant,
more than five hundred thousand teenagers
carried their babies to term, and over one-half
of the babies born to such teenagers were born
out of wedlock;
(2) adolescents aged seventeen and younger
accounted for more than one-half of the out of
wedlock births to teenagers;
(3) in a high proportion of cases, the pregnant adolescent is herself the product of an
unmarried parenthood during adolescence and
is continuing the pattern in her own lifestyle;

Page 1130

(4) it is estimated that approximately 80 per
centum of unmarried teenagers who carry
their pregnancies to term live with their families before and during their pregnancy and remain with their families after the birth of the
child;
(5) pregnancy and childbirth among unmarried adolescents, particularly young adolescents, often results in severe adverse health,
social, and economic consequences including:
a higher percentage of pregnancy and childbirth complications; a higher incidence of low
birth weight babies; a higher infant mortality
and morbidity; a greater likelihood that an
adolescent marriage will end in divorce; a decreased likelihood of completing schooling;
and higher risks of unemployment and welfare
dependency; and therefore, education, training, and job research services are important
for adolescent parents;
(6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for their children since
adoption is a means of providing permanent
families for such children from available approved couples who are unable or have difficulty in conceiving or carrying children of
their own to term; and
(B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into an adoption plan or arrange for their babies to be cared for by relatives or friends;
(7) an unmarried adolescent who becomes
pregnant once is likely to experience recurrent pregnancies and childbearing, with increased risks;
(8)(A) the problems of adolescent premarital
sexual relations, pregnancy, and parenthood
are multiple and complex and are frequently
associated with or are a cause of other troublesome situations in the family; and
(B) such problems are best approached
through a variety of integrated and essential
services provided to adolescents and their families by other family members, religious and
charitable organizations, voluntary associations, and other groups in the private sector as
well as services provided by publicly sponsored
initiatives;
(9) a wide array of educational, health, and
supportive services are not available to adolescents with such problems or to their families,
or when available frequently are fragmented
and thus are of limited effectiveness in discouraging adolescent premarital sexual relations and the consequences of such relations;
(10)(A) prevention of adolescent sexual activity and adolescent pregnancy depends primarily upon developing strong family values
and close family ties, and since the family is
the basic social unit in which the values and
attitudes of adolescents concerning sexuality
and pregnancy are formed, programs designed
to deal with issues of sexuality and pregnancy
will be successful to the extent that such programs encourage and sustain the role of the
family in dealing with adolescent sexual activity and adolescent pregnancy;
(B) Federal policy therefore should encourage the development of appropriate health,

Page 1131

TITLE 42—THE PUBLIC HEALTH AND WELFARE

educational, and social services where such
services are now lacking or inadequate, and
the better coordination of existing services
where they are available; and
(C) services encouraged by the Federal Government should promote the involvement of
parents with their adolescent children, and
should emphasize the provision of support by
other family members, religious and charitable organizations, voluntary associations,
and other groups in the private sector in order
to help adolescents and their families deal
with complex issues of adolescent premarital
sexual relations and the consequences of such
relations; and
(11)(A) there has been limited research concerning the societal causes and consequences
of adolescent pregnancy;
(B) there is limited knowledge concerning
which means of intervention are effective in
mediating or eliminating adolescent premarital sexual relations and adolescent pregnancy; and
(C) it is necessary to expand and strengthen
such knowledge in order to develop an array of
approaches to solving the problems of adolescent premarital sexual relations and adolescent pregnancy in both urban and rural settings.
(b) Therefore, the purposes of this subchapter
are—
(1) to find effective means, within the context of the family, of reaching adolescents before they become sexually active in order to
maximize the guidance and support available
to adolescents from parents and other family
members, and to promote self discipline and
other prudent approaches to the problem of
adolescent premarital sexual relations, including adolescent pregnancy;
(2) to promote adoption as an alternative for
adolescent parents;
(3) to establish innovative, comprehensive,
and integrated approaches to the delivery of
care services both for pregnant adolescents,
with primary emphasis on unmarried adolescents who are seventeen years of age or under,
and for adolescent parents, which shall be
based upon an assessment of existing programs and, where appropriate, upon efforts to
establish better coordination, integration, and
linkages among such existing programs in
order to—
(A) enable pregnant adolescents to obtain
proper care and assist pregnant adolescents
and adolescent parents to become productive
independent contributors to family and community life; and
(B) assist families of adolescents to understand and resolve the societal causes which
are associated with adolescent pregnancy;
(4) to encourage and support research
projects and demonstration projects concerning the societal causes and consequences of adolescent premarital sexual relations, contraceptive use, pregnancy, and child rearing;
(5) to support evaluative research to identify
effective services which alleviate, eliminate,
or resolve any negative consequences of adolescent premarital sexual relations and adoles-

§ 300z–1

cent childbearing for the parents, the child,
and their families; and
(6) to encourage and provide for the dissemination of results, findings, and information
from programs and research projects relating
to adolescent premarital sexual relations,
pregnancy, and parenthood.
(July 1, 1944, ch. 373, title XX, § 2001, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 578; amended Pub. L. 98–512, § 2(b), (c), Oct.
19, 1984, 98 Stat. 2409.)
AMENDMENTS
1984—Subsec. (a)(5). Pub. L. 98–512, § 2(b), struck out
reference relating to developmental disabilities and inserted provision relating to importance of education,
training, and job research services for adolescent parents.
Subsec. (b)(3). Pub. L. 98–512, § 2(c), inserted ‘‘both’’
before ‘‘for pregnant adolescents’’.

§ 300z–1. Definitions; regulations applicable
(a) For the purposes of this subchapter, the
term—
(1) ‘‘Secretary’’ means the Secretary of
Health and Human Services;
(2) ‘‘eligible person’’ means—
(A) with regard to the provision of care
services, a pregnant adolescent, an adolescent parent, or the family of a pregnant adolescent or an adolescent parent; or
(B) with regard to the provision of prevention services and referral to such other services which may be appropriate, a nonpregnant adolescent;
(3) ‘‘eligible grant recipient’’ means a public
or nonprofit private organization or agency
which demonstrates, to the satisfaction of the
Secretary—
(A) in the case of an organization which
will provide care services, the capability of
providing all core services in a single setting
or the capability of creating a network
through which all core services would be
provided; or
(B) in the case of an organization which
will provide prevention services, the capability of providing such services;
(4) ‘‘necessary services’’ means services
which may be provided by grantees which
are—
(A) pregnancy testing and maternity counseling;
(B) adoption counseling and referral services which present adoption as an option for
pregnant adolescents, including referral to
licensed adoption agencies in the community if the eligible grant recipient is not a licensed adoption agency;
(C) primary and preventive health services
including prenatal and postnatal care;
(D) nutrition information and counseling;
(E) referral for screening and treatment of
venereal disease;
(F) referral to appropriate pediatric care;
(G) educational services relating to family
life and problems associated with adolescent
premarital sexual relations, including—
(i) information about adoption;
(ii) education on the responsibilities of
sexuality and parenting;

§ 300z–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iii) the development of material to support the role of parents as the provider of
sex education; and
(iv) assistance to parents, schools, youth
agencies, and health providers to educate
adolescents and preadolescents concerning
self-discipline and responsibility in human
sexuality;
(H) appropriate educational and vocational
services;
(I) referral to licensed residential care or
maternity home services; and
(J) mental health services and referral to
mental health services and to other appropriate physical health services;
(K) child care sufficient to enable the adolescent parent to continue education or to
enter into employment;
(L) consumer education and homemaking;
(M) counseling for the immediate and extended family members of the eligible person;
(N) transportation;
(O) outreach services to families of adolescents to discourage sexual relations among
unemancipated minors;
(P) family planning services; and
(Q) such other services consistent with the
purposes of this subchapter as the Secretary
may approve in accordance with regulations
promulgated by the Secretary;
(5) ‘‘core services’’ means those services
which shall be provided by a grantee, as determined by the Secretary by regulation;
(6) ‘‘supplemental services’’ means those
services which may be provided by a grantee,
as determined by the Secretary by regulation;
(7) ‘‘care services’’ means necessary services
for the provision of care to pregnant adolescents and adolescent parents and includes all
core services with respect to the provision of
such care prescribed by the Secretary by regulation;
(8) ‘‘prevention services’’ means necessary
services to prevent adolescent sexual relations, including the services described in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O),
and (Q) of paragraph (4);
(9) ‘‘adolescent’’ means an individual under
the age of nineteen; and
(10) ‘‘unemancipated minor’’ means a minor
who is subject to the control, authority, and
supervision of his or her parents or guardians,
as determined under State law.
(b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this subsection, the Secretary shall use
the regulations promulgated under title VI of
the Health Services and Centers Amendments of
1978 [42 U.S.C. 300a–21 et seq.] which were in effect on August 13, 1981, to determine which necessary services are core services for purposes of
this subchapter. The Secretary may promulgate
regulations to determine which necessary services are core services for purposes of this subchapter based upon an evaluation of and information concerning which necessary services are
essential to carry out the purposes of this subchapter and taking into account (1) factors such
as whether services are to be provided in urban

Page 1132

or rural areas, the ethnic groups to be served,
and the nature of the populations to be served,
and (2) the results of the evaluations required
under section 300z–5(b) of this title. The Secretary may from time to time revise such regulations.
(July 1, 1944, ch. 373, title XX, § 2002, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 580; amended Pub. L. 98–512, § 2(d), Oct. 19,
1984, 98 Stat. 2409.)
REFERENCES IN TEXT
The Health Services and Centers Amendments of 1978,
referred to in subsec. (b), is Pub. L. 95–626, Nov. 10, 1978,
92 Stat. 3551, as amended. Title VI of the Health Services and Centers Amendments of 1978 was classified
generally to part A (§ 300a–21 et seq.) of subchapter
VIII–A of this chapter prior to its repeal by Pub. L.
97–35, title IX, § 955(b), title XXI, § 2193(f), Aug. 13, 1981,
95 Stat. 592, 828. For complete classification of this Act
to the Code, see Short Title of 1978 Amendments note
set out under section 201 of this title and Tables.
AMENDMENTS
1984—Subsec. (a)(4)(H). Pub. L. 98–512 struck out ‘‘and
referral to such services’’ after ‘‘vocational services’’.

§ 300z–2. Demonstration projects; grant authorization, etc.
(a) The Secretary may make grants to further
the purposes of this subchapter to eligible grant
recipients which have submitted an application
which the Secretary finds meets the requirements of section 300z–5 of this title for demonstration projects which the Secretary determines will help communities provide appropriate care and prevention services in easily accessible locations. Demonstration projects shall,
as appropriate, provide, supplement, or improve
the quality of such services. Demonstration
projects shall use such methods as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of adolescents and to make use of support systems
such as other family members, friends, religious
and charitable organizations, and voluntary associations.
(b) Grants under this subchapter for demonstration projects may be for the provision of—
(1) care services;
(2) prevention services; or
(3) a combination of care services and prevention services.
(July 1, 1944, ch. 373, title XX, § 2003, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 582.)
§ 300z–3. Uses of grants
projects for services

for

demonstration

(a) Covered projects
Except as provided in subsection (b) of this
section, funds provided for demonstration
projects for services under this subchapter may
be used by grantees only to—
(1) provide to eligible persons—
(A) care services;
(B) prevention services; or
(C) care and prevention services (in the
case of a grantee who is providing a combination of care and prevention services);

Page 1133

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) coordinate, integrate, and provide linkages among providers of care, prevention, and
other services for eligible persons in furtherance of the purposes of this subchapter;
(3) provide supplemental services where such
services are not adequate or not available to
eligible persons in the community and which
are essential to the care of pregnant adolescents and to the prevention of adolescent premarital sexual relations and adolescent pregnancy;
(4) plan for the administration and coordination of pregnancy prevention services and programs of care for pregnant adolescents and adolescent parents which will further the objectives of this subchapter; and
(5) fulfill assurances required for grant approval by section 300z–5 of this title.
(b) Family planning services; availability in community
(1) No funds provided for a demonstration
project for services under this subchapter may
be used for the provision of family planning
services (other than counseling and referral
services) to adolescents unless appropriate family planning services are not otherwise available
in the community.
(2) Any grantee who receives funds for a demonstration project for services under this subchapter and who, after determining under paragraph (1) that appropriate family planning services are not otherwise available in the community, provides family planning services (other
than counseling and referral services) to adolescents may only use funds provided under this
subchapter for such family planning services if
all funds received by such grantee from all other
sources to support such family planning services
are insufficient to support such family planning
services.
(c) Fees for services: criteria
Grantees who receive funds for a demonstration project for services under this subchapter
shall charge fees for services pursuant to a fee
schedule approved by the Secretary as a part of
the application described in section 300z–5 of
this title which bases fees charged by the grantee on the income of the eligible person or the
parents or legal guardians of the eligible person
and takes into account the difficulty adolescents face in obtaining resources to pay for services. A grantee who receives funds for a demonstration project for services under this subchapter may not, in any case, discriminate with
regard to the provision of services to any individual because of that individual’s inability to
provide payment for such services, except that
in determining the ability of an unemancipated
minor to provide payment for services, the income of the family of an unemancipated minor
shall be considered in determining the ability of
such minor to make such payments unless the
parents or guardians of the unemancipated
minor refuse to make such payments.
(July 1, 1944, ch. 373, title XX, § 2004, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 583.)

§ 300z–4

§ 300z–4. Grants for demonstration projects for
services
(a) Priorities
In approving applications for grants for demonstration projects for services under this subchapter, the Secretary shall give priority to applicants who—
(1) serve an area where there is a high incidence of adolescent pregnancy;
(2) serve an area with a high proportion of
low-income families and where the availability of programs of care for pregnant adolescents and adolescent parents is low;
(3) show evidence—
(A) in the case of an applicant who will
provide care services, of having the ability
to bring together a wide range of needed
core services and, as appropriate, supplemental services in comprehensive single-site
projects, or to establish a well-integrated
network of such services (appropriate for the
target population and geographic area to be
served including the special needs of rural
areas) for pregnant adolescents or adolescent parents; or
(B) in the case of an applicant who will
provide prevention services, of having the
ability to provide prevention services for
adolescents and their families which are appropriate for the target population and the
geographic area to be served, including the
special needs of rural areas;
(4) will utilize to the maximum extent feasible existing available programs and facilities
such as neighborhood and primary health care
centers, maternity homes which provide or
can be equipped to provide services to pregnant adolescents, agencies serving families,
youth, and children with established programs
of service to pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth centers, maternal and infant
health centers, regional rural health facilities,
school and other educational programs, mental health programs, nutrition programs,
recreation programs, and other ongoing pregnancy prevention services and programs of
care for pregnant adolescents and adolescent
parents;
(5) make use, to the maximum extent feasible, of other Federal, State, and local funds,
programs, contributions, and other third-party
reimbursements;
(6) can demonstrate a community commitment to the program by making available to
the demonstration project non-Federal funds,
personnel, and facilities;
(7) have involved the community to be
served, including public and private agencies,
adolescents, and families, in the planning and
implementation of the demonstration project;
and
(8) will demonstrate innovative and effective
approaches in addressing the problems of adolescent premarital sexual relations, pregnancy, or parenthood, including approaches to
provide pregnant adolescents with adequate
information about adoption.

§ 300z–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Factors to be considered in making grants;
special needs of rural areas
(1) The amount of a grant for a demonstration
project for services under this subchapter shall
be determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the geographic area to be served, and
the adequacy of pregnancy prevention services
and programs of care for pregnant adolescents
and adolescent parents in such area.
(2) In making grants for demonstration
projects for services under this subchapter, the
Secretary shall consider the special needs of
rural areas and, to the maximum extent practicable, shall distribute funds taking into consideration the relative number of adolescents in
such areas in need of such services.
(c) Duration; Federal share
(1) A grantee may not receive funds for a demonstration project for services under this subchapter for a period in excess of 5 years.
(2)(A) Subject to paragraph (3), a grant for a
demonstration project for services under this
subchapter may not exceed—
(i) 70 per centum of the costs of the project
for the first and second years of the project;
(ii) 60 per centum of such costs for the third
year of the project;
(iii) 50 per centum of such costs for the
fourth year of the project; and
(iv) 40 per centum of such costs for the fifth
year of the project.
(B) Non-Federal contributions required by subparagraph (A) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services.
(3) The Secretary may waive the limitation
specified in paragraph (2)(A) for any year in accordance with criteria established by regulation.
(July 1, 1944, ch. 373, title XX, § 2005, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 584.)
§ 300z–5. Requirements for applications
(a) Form, content, and assurances
An application for a grant for a demonstration
project for services under this subchapter shall
be in such form and contain such information as
the Secretary may require, and shall include—
(1) an identification of the incidence of adolescent pregnancy and related problems;
(2) a description of the economic conditions
and income levels in the geographic area to be
served;
(3) a description of existing pregnancy prevention services and programs of care for pregnant adolescents and adolescent parents (including adoption services), and including
where, how, by whom, and to which population
groups such services are provided, and the extent to which they are coordinated in the geographic area to be served;
(4) a description of the major unmet needs
for services for adolescents at risk of initial or
recurrent pregnancies and an estimate of the
number of adolescents not being served in the
area;
(5)(A) in the case of an applicant who will
provide care services, a description of how all

Page 1134

core services will be provided in the demonstration project using funds under this subchapter or will otherwise be provided by the
grantee in the area to be served, the population to which such services will be provided,
how such services will be coordinated, integrated, and linked with other related programs and services and the source or sources
of funding of such core services in the public
and private sectors; or
(B) in the case of an applicant who will provide prevention services, a description of the
necessary services to be provided and how the
applicant will provide such services;
(6) a description of the manner in which adolescents needing services other than the services provided directly by the applicant will be
identified and how access and appropriate referral to such other services (such as medicaid;
licensed adoption agencies; maternity home
services; public assistance; employment services; child care services for adolescent parents;
and other city, county, and State programs related to adolescent pregnancy) will be provided, including a description of a plan to
coordinate such other services with the services supported under this subchapter;
(7) a description of the applicant’s capacity
to continue services as Federal funds decrease
and in the absence of Federal assistance;
(8) a description of the results expected from
the provision of services, and the procedures
to be used for evaluating those results;
(9) a summary of the views of public agencies, providers of services, and the general
public in the geographic area to be served,
concerning the proposed use of funds provided
for a demonstration project for services under
this subchapter and a description of procedures used to obtain those views, and, in the
case of applicants who propose to coordinate
services administered by a State, the written
comments of the appropriate State officials
responsible for such services;
(10) assurances that the applicant will have
an ongoing quality assurance program;
(11) assurances that, where appropriate, the
applicant shall have a system for maintaining
the confidentiality of patient records in accordance with regulations promulgated by the
Secretary;
(12) assurances that the applicant will demonstrate its financial responsibility by the use
of such accounting procedures and other requirements as may be prescribed by the Secretary;
(13) assurances that the applicant (A) has or
will have a contractual or other arrangement
with the agency of the State (in which the applicant provides services) that administers or
supervises the administration of a State plan
approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the payment of all or a part of the applicant’s costs in
providing health services to persons who are
eligible for medical assistance under such a
State plan, or (B) has made or will make every
reasonable effort to enter into such an arrangement;
(14) assurances that the applicant has made
or will make and will continue to make every

Page 1135

TITLE 42—THE PUBLIC HEALTH AND WELFARE

reasonable effort to collect appropriate reimbursement for its costs in providing health
services to persons who are entitled to benefits under title V of the Social Security Act
[42 U.S.C. 701 et seq.], to medical assistance
under a State plan approved under title XIX of
such Act [42 U.S.C. 1396 et seq.], or to assistance for medical expenses under any other
public assistance program or private health
insurance program;
(15) assurances that the applicant has or will
make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing services to persons entitled to services under parts B and E
of title IV [42 U.S.C. 620 et seq., 670 et seq.] and
title XX of the Social Security Act [42 U.S.C.
1397 et seq.];
(16)(A) a description of—
(i) the schedule of fees to be used in the
provision of services, which shall comply
with section 300z–3(c) of this title and which
shall be designed to cover all reasonable direct and indirect costs incurred by the applicant in providing services; and
(ii) a corresponding schedule of discounts
to be applied to the payment of such fees,
which shall comply with section 300z–3(c) of
this title and which shall be adjusted on the
basis of the ability of the eligible person to
pay;
(B) assurances that the applicant has made
and will continue to make every reasonable effort—
(i) to secure from eligible persons payment
for services in accordance with such schedules;
(ii) to collect reimbursement for health or
other services provided to persons who are
entitled to have payment made on their behalf for such services under any Federal or
other government program or private insurance program; and
(iii) to seek such reimbursement on the
basis of the full amount of fees for services
without application of any discount; and
(C) assurances that the applicant has submitted or will submit to the Secretary such
reports as the Secretary may require to determine compliance with this paragraph;
(17) assurances that the applicant will make
maximum use of funds available under subchapter VIII of this chapter;
(18) assurances that the acceptance by any
individual of family planning services or family planning information (including educational materials) provided through financial
assistance under this subchapter shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service furnished by the applicant;
(19) assurances that fees collected by the applicant for services rendered in accordance
with this subchapter shall be used by the applicant to further the purposes of this subchapter;
(20) assurances that the applicant, if providing both prevention and care services will not
exclude or discriminate against any adolescent who receives prevention services and sub-

§ 300z–5

sequently requires care services as a pregnant
adolescent;
(21) a description of how the applicant will,
as appropriate in the provision of services—
(A) involve families of adolescents in a
manner which will maximize the role of the
family in the solution of problems relating
to the parenthood or pregnancy of the adolescent;
(B) involve religious and charitable organizations, voluntary associations, and other
groups in the private sector as well as services provided by publicly sponsored initiatives;
(22)(A) assurances that—
(i) except as provided in subparagraph (B)
and subject to clause (ii), the applicant will
notify the parents or guardians of any unemancipated minor requesting services from
the applicant and, except as provided in subparagraph (C), will obtain the permission of
such parents or guardians with respect to
the provision of such services; and
(ii) in the case of a pregnant unemancipated minor requesting services from the applicant, the applicant will notify the parents
or guardians of such minor under clause (i)
within a reasonable period of time;
(B) assurances that the applicant will not
notify or request the permission of the parents
or guardian of any unemancipated minor without the consent of the minor—
(i) who solely is requesting from the applicant pregnancy testing or testing or treatment for venereal disease;
(ii) who is the victim of incest involving a
parent; or
(iii) if an adult sibling of the minor or an
adult aunt, uncle, or grandparent who is related to the minor by blood certifies to the
grantee that notification of the parents or
guardians of such minor would result in
physical injury to such minor; and
(C) assurances that the applicant will not require, with respect to the provision of services, the permission of the parents or guardians of any pregnant unemancipated minor if
such parents or guardians are attempting to
compel such minor to have an abortion;
(23) assurances that primary emphasis for
services supported under this subchapter shall
be given to adolescents seventeen and under
who are not able to obtain needed assistance
through other means;
(24) assurances that funds received under
this subchapter shall supplement and not supplant funds received from any other Federal,
State, or local program or any private sources
of funds; and
(25) a plan for the conduct of, and assurances
that the applicant will conduct, evaluations of
the effectiveness of the services supported
under this subchapter in accordance with subsection (b) of this section.
(b) Evaluations: amount, conduct, and technical
assistance
(1) Each grantee which receives funds for a
demonstration project for services under this
subchapter shall expend at least 1 per centum

§ 300z–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1136

REFERENCES IN TEXT

but not in excess of 5 per centum of the amounts
received under this subchapter for the conduct
of evaluations of the services supported under
this subchapter. The Secretary may, for a particular grantee upon good cause shown, waive
the provisions of the preceding sentence with respect to the amounts to be expended on evaluations, but may not waive the requirement that
such evaluations be conducted.
(2) Evaluations required by paragraph (1) shall
be conducted by an organization or entity which
is independent of the grantee providing services
supported under this subchapter. To assist in
conducting the evaluations required by paragraph (1), each grantee shall develop a working
relationship with a college or university located
in the grantee’s State which will provide or assist in providing monitoring and evaluation of
services supported under this subchapter unless
no college or university in the grantee’s State is
willing or has the capacity to provide or assist
in providing such monitoring and assistance.
(3) The Secretary may provide technical assistance with respect to the conduct of evaluations required under this subsection to any
grantee which is unable to develop a working relationship with a college or university in the applicant’s State for the reasons described in paragraph (2).
(c) Reports
Each grantee which receives funds for a demonstration project for services under this subchapter shall make such reports concerning its
use of Federal funds as the Secretary may require. Reports shall include, at such times as
are considered appropriate by the Secretary, the
results of the evaluations of the services supported under this subchapter.
(d) Notification of parents; ‘‘adult’’ defined
(1) A grantee shall periodically notify the Secretary of the exact number of instances in which
a grantee does not notify the parents or guardians of a pregnant unemancipated minor under
subsection (a)(22)(B)(iii) of this section.
(2) For purposes of subsection (a)(22)(B)(iii) of
this section, the term ‘‘adult’’ means an adult as
defined by State law.
(e) Submission of applications to Governor; comments by Governor
Each applicant shall provide the Governor of
the State in which the applicant is located a
copy of each application submitted to the Secretary for a grant for a demonstration project
for services under this subchapter. The Governor
shall submit to the applicant comments on any
such application within the period of sixty days
beginning on the day when the Governor receives such copy. The applicant shall include the
comments of the Governor with such application.
(f) Availability of core services
No application submitted for a grant for a
demonstration project for care services under
this subchapter may be approved unless the Secretary is satisfied that core services shall be
available through the applicant within a reasonable time after such grant is received.

(b) Any recipient of a grant for a demonstration project for services under this subchapter
shall coordinate its activities with any other recipient of such a grant which is located in the
same locality.

(July 1, 1944, ch. 373, title XX, § 2006, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 585.)

(July 1, 1944, ch. 373, title XX, § 2007, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 589.)

The Social Security Act, referred to in subsec. (a)(13)
to (15), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Parts B and E of title IV of the Social Security Act are classified generally to part B (§ 620 et seq.)
and part E (§ 670 et seq.) of subchapter IV of chapter 7
of this title. Titles V, XIX, and XX of the Social Security Act are classified generally to subchapters V (§ 701
et seq.), XIX (§ 1396 et seq.), and XX (§ 1397 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of
this title and Tables.

§ 300z–6. Coordination of programs
(a) The Secretary shall coordinate Federal
policies and programs providing services relating to the prevention of adolescent sexual relations and initial and recurrent adolescent pregnancies and providing care services for pregnant
adolescents. In achieving such coordination, the
Secretary shall—
(1) require grantees who receive funds for
demonstration projects for services under this
subchapter to report periodically to the Secretary concerning Federal, State, and local
policies and programs that interfere with the
delivery of and coordination of pregnancy prevention services and other programs of care
for pregnant adolescents and adolescent parents;
(2) provide technical assistance to facilitate
coordination by State and local recipients of
Federal assistance;
(3) review all programs administered by the
Department of Health and Human Services
which provide prevention services or care services to determine if the policies of such programs are consistent with the policies of this
subchapter, consult with other departments
and agencies of the Federal Government who
administer programs that provide such services, and encourage such other departments
and agencies to make recommendations, as appropriate, for legislation to modify such programs in order to facilitate the use of all Government programs which provide such services
as a basis for delivery of more comprehensive
prevention services and more comprehensive
programs of care for pregnant adolescents and
adolescent parents;
(4) give priority in the provision of funds,
where appropriate, to applicants using single
or coordinated grant applications for multiple
programs; and
(5) give priority, where appropriate, to the
provision of funds under Federal programs administered by the Secretary (other than the
program established by this subchapter) to
projects providing comprehensive prevention
services and comprehensive programs of care
for pregnant adolescents and adolescent parents.

Page 1137

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300z–7. Research
(a) Grants and contracts; duration; renewal;
amount
(1) The Secretary may make grants and enter
into contracts with public agencies or private
organizations or institutions of higher education to support the research and dissemination activities described in paragraphs (4), (5),
and (6) of section 300z(b) of this title.
(2) The Secretary may make grants or enter
into contracts under this section for a period of
one year. A grant or contract under this section
for a project may be renewed for four additional
one-year periods, which need not be consecutive.
(3) A grant or contract for any one-year period
under this section may not exceed $100,000 for
the direct costs of conducting research or
disemination 1 activities under this section and
may include such additional amounts for the indirect costs of conducting such activities as the
Secretary determines appropriate. The Secretary may waive the preceding sentence with
respect to a specific project if he determines
that—
(A) exceptional circumstances warrant such
waiver and that the project will have national
impact; or
(B) additional amounts are necessary for the
direct costs of conducting limited demonstration projects for the provision of necessary
services in order to provide data for research
carried out under this subchapter.
(4) The amount of any grant or contract made
under this section may remain available for obligation or expenditure after the close of the
one-year period for which such grant or contract
is made in order to assist the recipient in preparing the report required by subsection (f)(1) of
this section.
(b) Scope of permissible activities
(1) Funds provided for research under this section may be used for descriptive or explanatory
surveys, longitudinal studies, or limited demonstration projects for services that are for the
purpose of increasing knowledge and understanding of the matters described in paragraphs
(4) and (5) of section 300z(b) of this title.
(2) Funds provided under this section may not
be used for the purchase or improvement of
land, or the purchase, construction, or permanent improvement (other than minor remodeling) of any building or facility.
(c) Applications
The Secretary may not make any grant or
enter into any contract to support research or
dissemination activities under this section unless—
(1) the Secretary has received an application
for such grant or contract which is in such
form and which contains such information as
the Secretary may by regulation require;
(2) the applicant has demonstrated that the
applicant is capable of conducting one or more
of the types of research or dissemination activities described in paragraph (4), (5), or (6) of
section 300z(b) of this title; and
1 So

in original. Probably should be ‘‘dissemination’’.

§ 300z–7

(3) in the case of an application for a research project, the panel established by subsection (e)(2) of this section has determined
that the project is of scientific merit.
(d) Coordination with National Institutes of
Health
The Secretary shall, where appropriate, coordinate research and dissemination activities
carried out under this section with research and
dissemination activities carried out by the National Institutes of Health.
(e) Review of applications for grants and contracts; establishment of review panel
(1) The Secretary shall establish a system for
the review of applications for grants and contracts under this section. Such system shall be
substantially similar to the system for scientific
peer review of the National Institutes of Health
and shall meet the requirements of paragraphs
(2) and (3).
(2) In establishing the system required by
paragraph (1), the Secretary shall establish a
panel to review applications under this section.
Not more than 25 per centum of the members of
the panel shall be physicians. The panel shall
meet as often as may be necessary to facilitate
the expeditious review of applications under this
section, but not less than once each year. The
panel shall review each project for which an application is made under this section, evaluate
the scientific merit of the project, determine
whether the project is of scientific merit, and
make recommendations to the Secretary concerning whether the application for the project
should be approved.
(3) The Secretary shall make grants under this
section from among the projects which the panel
established by paragraph (2) has determined to
be of scientific merit and may only approve an
application for a project if the panel has made
such determination with respect to such a
project. The Secretary shall make a determination with respect to an application within one
month after receiving the determinations and
recommendations of such panel with respect to
the application.
(f) Reports
(1)(A) The recipient of a grant or contract for
a research project under this section shall prepare and transmit to the Secretary a report describing the results and conclusions of such research. Except as provided in subparagraph (B),
such report shall be transmitted to the Secretary not later than eighteen months after the
end of the year for which funds are provided
under this section. The recipient may utilize reprints of articles published or accepted for publication in professional journals to supplement or
replace such report if the research contained in
such articles was supported under this section
during the year for which the report is required.
(B) In the case of any research project for
which assistance is provided under this section
for two or more consecutive one-year periods,
the recipient of such assistance shall prepare
and transmit the report required by subparagraph (A) to the Secretary not later than twelve
months after the end of each one-year period for
which such funding is provided.

§ 300z–8

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Recipients of grants and contracts for dissemination under this section shall submit to
the Secretary such reports as the Secretary determines appropriate.
(July 1, 1944, ch. 373, title XX, § 2008, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 589; amended Pub. L. 98–512, § 2(e), Oct. 19,
1984, 98 Stat. 2409.)
AMENDMENTS
1984—Subsec. (g). Pub. L. 98–512 struck out subsec. (g)
which provided for collection of survey data used primarily for generation of national population estimates.

§ 300z–8. Evaluation and administration
(a) Of the funds appropriated under this subchapter, the Secretary shall reserve not less
than 1 per centum and not more than 3 per centum for the evaluation of activities carried out
under this subchapter. The Secretary shall submit to the appropriate committees of the Congress a summary of each evaluation conducted
under this section.
(b) The officer or employee of the Department
of Health and Human Services designated by the
Secretary to carry out the provisions of this
subchapter shall report directly to the Assistant
Secretary for Health with respect to the activities of such officer or employee in carrying out
such provisions.
(July 1, 1944, ch. 373, title XX, § 2009, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 591.)
§ 300z–9. Authorization of appropriations
(a) For the purpose of carrying out this subchapter, there are authorized to be appropriated
$30,000,000 for the fiscal year ending September
30, 1982, $30,000,000 for the fiscal year ending September 30, 1983, $30,000,000 for the fiscal year
ending September 30, 1984, and $30,000,000 for the
fiscal year ending September 30, 1985.
(b) At least two-thirds of the amounts appropriated to carry out this subchapter shall be
used to make grants for demonstration projects
for services.
(c) Not more than one-third of the amounts
specified under subsection (b) of this section for
use for grants for demonstration projects for
services shall be used for grants for demonstration projects for prevention services.
(July 1, 1944, ch. 373, title XX, § 2010, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 591; amended Pub. L. 98–512, § 2(a), Oct. 19,
1984, 98 Stat. 2409.)
AMENDMENTS
1984—Subsec. (a). Pub. L. 98–509 inserted provisions
authorizing appropriations for fiscal year ending Sept.
30, 1985.

§ 300z–10. Restrictions
(a) Grants or payments may be made only to
programs or projects which do not provide abortions or abortion counseling or referral, or
which do not subcontract with or make any payment to any person who provides abortions or
abortion counseling or referral, except that any
such program or project may provide referral for

Page 1138

abortion counseling to a pregnant adolescent if
such adolescent and the parents or guardians of
such adolescent request such referral; and
grants may be made only to projects or programs which do not advocate, promote, or encourage abortion.
(b) The Secretary shall ascertain whether programs or projects comply with subsection (a) of
this section and take appropriate action if programs or projects do not comply with such subsection, including withholding of funds.
(July 1, 1944, ch. 373, title XX, § 2011, as added
Pub. L. 97–35, title IX, § 955(a), Aug. 13, 1981, 95
Stat. 592.)
SUBCHAPTER XIX—VACCINES
PRIOR PROVISIONS
A prior subchapter XIX (§ 300aa et seq.), comprised of
title XXI of the Public Health Service Act, act July 1,
1944, ch. 373, §§ 2101 to 2116, was renumbered title XXIII,
§§ 2301 to 2316, of the Public Health Service Act, and
transferred to subchapter XXI (§ 300cc et seq.) of this
chapter, renumbered title XXV, §§ 2501 to 2514, of the
Public Health Service Act, and transferred to subchapter XXV (§ 300aaa et seq.) of this chapter, renumbered title XXVI, §§ 2601 to 2614, of the Public Health
Service Act, renumbered title XXVII, §§ 2701 to 2714, of
the Public Health Service Act, and renumbered title II,
part B, §§ 231 to 244, of the Public Health Service Act,
and transferred to part B (§ 238 et seq.) of subchapter I
of this chapter.

PART 1—NATIONAL VACCINE PROGRAM
§ 300aa–1. Establishment
The Secretary shall establish in the Department of Health and Human Services a National
Vaccine Program to achieve optimal prevention
of human infectious diseases through immunization and to achieve optimal prevention against
adverse reactions to vaccines. The Program
shall be administered by a Director selected by
the Secretary.
(July 1, 1944, ch. 373, title XXI, § 2101, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3756.)
PRIOR PROVISIONS
A prior section 300aa–1, act July 1, 1944, § 2102, was
successively renumbered by subsequent acts and transferred, see section 238a of this title.
A prior section 2101 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238 of this title.
EFFECTIVE DATE
Section 323 of title III of Pub. L. 99–660, as amended
by Pub. L. 100–203, title IV, § 4302(a), Dec. 22, 1987, 101
Stat. 1330–221; Pub. L. 102–168, title II, § 201(a), Nov. 26,
1991, 105 Stat. 1102, provided that: ‘‘Subtitle 1 of title
XXI of the Public Health Service Act [part 1 of this
subchapter (42 U.S.C. 300aa–1 to 300aa–6)] shall take effect on the date of the enactment of this Act [Nov. 14,
1986] and parts A and B of subtitle 2 of such title [subparts A and B of part 2 of this subchapter (42 U.S.C.
300aa–10 to 300aa–23)] shall take effect on October 1, 1988
and parts C and D of such title [subparts C and D of
part 2 of this subchapter (42 U.S.C. 300aa–25 to
300aa–33)] and this title [probably means provisions of
title III of Pub. L. 99–660 other than those that enacted
this subchapter and redesignated former sections 300aa
to 300aa–15 of this title as sections 300cc to 300cc–15 of
this title; these other provisions amended sections 218,

Page 1139

TITLE 42—THE PUBLIC HEALTH AND WELFARE

242c, 262, 286, and 289f of this title and enacted provisions set out as notes under sections 201, 300aa–1, and
300aa–4 of this title] shall take effect on the date of the
enactment of the Vaccine Compensation Amendments
of 1987 [Dec. 22, 1987].’’
SEVERABILITY
Section 322 of title III of Pub. L. 99–660, as amended
by Pub. L. 101–239, title VI, § 6602, Dec. 19, 1989, 103 Stat.
2293; Pub. L. 101–502, § 5(g)(1), Nov. 3, 1990, 104 Stat. 1288,
provided that:
‘‘(a) IN GENERAL.—Except as provided in subsection
(b), if any provision [of] part A or B of subtitle 2 of title
XXI of the Public Health Service Act [subparts A and
B of part 2 of this subchapter], as added by section
311(a), or the application of such a provision to any person or circumstance is held invalid by reason of a violation of the Constitution, both such parts shall be considered invalid.
‘‘(b) SPECIAL RULE.—If any amendment made by section 6601 of the Omnibus Budget Reconciliation Act of
1989 [Pub. L. 101–239, amending sections 300aa–10 to
300aa–17, 300aa–21, 300aa–23, 300aa–26, and 300aa–27 of
this title] to title XXI of the Public Health Service Act
[this subchapter] or the application of such a provision
to any person or circumstance is held invalid by reason
of the Constitution, subsection (a) shall not apply and
such title XXI of the Public Health Service Act without
such amendment shall continue in effect.’’
[Amendment by section 5(g)(1) of Pub. L. 101–502 to
section 322(a) of Pub. L. 99–660, set out above, effective
Nov. 14, 1986, see section 5(h) of Pub. L. 101–502, set out
as an Effective Date of 1990 Amendment note under section 300aa–11 of this title.]
EVALUATION OF PROGRAM; STUDY AND REPORT TO
CONGRESS
Pub. L. 101–239, title VI, § 6601(t), Dec. 19, 1989, 103
Stat. 2293, as amended by Pub. L. 102–168, title II,
§ 201(b), Nov. 26, 1991, 105 Stat. 1103, directed the Secretary of Health and Human Services to evaluate the
National Vaccine Injury Compensation Program under
this subchapter and report results of such study to
Committee on Energy and Commerce of House of Representatives and Committee on Labor and Human Resources of Senate not later than Jan. 1, 1993.
RELATED STUDIES
Section 312 of title III of Pub. L. 99–660 directed Secretary of Health and Human Services, not later than 3
years after the effective date of this title (see Effective
Date note above), to conduct, through studies by the
Institute of Medicine of the National Academy of Sciences or other appropriate nonprofit private groups or
associations, a review of pertussis vaccines and related
illnesses and conditions and MMR vaccines, vaccines
containing material intended to prevent or confer immunity against measles, mumps, and rubella disease,
and related illnesses and conditions, make specific findings and report these findings in the Federal Register
not later than 3 years after the effective date of this
title, and at the same time these findings are published
in the Federal Register, propose regulations as a result
of such findings, and not later than 42 months after the
effective date of this title, promulgate such proposed
regulations with such modifications as may be necessary after opportunity for public hearing.
STUDY OF OTHER VACCINE RISKS
Section 313 of title III of Pub. L. 99–660 provided that:
‘‘(a) STUDY.—
‘‘(1) Not later than 3 years after the effective date
of this title [see Effective Date note above], the Secretary shall, after consultation with the Advisory
Commission on Childhood Vaccines established under
section 2119 of the Public Health Service Act [section
300aa–19 of this title]—
‘‘(A) arrange for a broad study of the risks (other
than the risks considered under section 102 [21

§ 300aa–1

U.S.C. 382]) to children associated with each vaccine set forth in the Vaccine Injury Table under
section 2114 of such Act [section 300aa–14 of this
title], and
‘‘(B) establish guidelines, after notice and opportunity for public hearing and consideration of all
relevant medical and scientific information, respecting the administration of such vaccines which
shall include—
‘‘(i) the circumstances under which any such
vaccine should not be administered,
‘‘(ii) the circumstances under which administration of any such vaccine should be delayed beyond
its usual time of administration, and
‘‘(iii) the groups, categories, or characteristics
of potential recipients of such vaccine who may
be at significantly higher risk of major adverse
reactions to such vaccine than the general population of potential recipients.
‘‘(2)(A) The Secretary shall request the Institute of
Medicine of the National Academy of Sciences to conduct the study required by paragraph (1) under an arrangement by which the actual expenses incurred by
such Academy in conducting such study will be paid
by the Secretary.
‘‘(B) If the Institute of Medicine is unwilling to conduct such study under such an arrangement, the Secretary shall enter into a similar arrangement with
other appropriate nonprofit private groups or associations under which such groups or associations will
conduct such study.
‘‘(C) The Institute of Medicine or other group or association conducting the study required by paragraph
(1) shall conduct such studies in consultation with
the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health
Service Act [section 300aa–19 of this title].
‘‘(b) REVISION OF GUIDELINES.—The Secretary shall
periodically, but at least every 3 years after establishing guidelines under subsection (a), review and revise
such guidelines after notice and opportunity for public
hearing and consideration of all relevant medical and
scientific information, unless the Secretary finds that
on the basis of all relevant information no revision of
such guidelines is warranted and publishes such finding
in the Federal Register.
‘‘(c) FACTORS AFFECTING GUIDELINES.—Guidelines
under subsection (a) shall take into account—
‘‘(1) the risk to potential recipients of the vaccines
with respect to which the guidelines are established,
‘‘(2) the medical and other characteristics of such
potential recipients, and
‘‘(3) the risks to the public of not having such vaccines administered.
‘‘(d) DISSEMINATION.—The Secretary shall widely disseminate the guidelines established under subsection
(a) to—
‘‘(1) physicians and other health care providers,
‘‘(2) professional health associations,
‘‘(3) State and local governments and agencies, and
‘‘(4) other relevant entities.’’
REVIEW OF WARNINGS, USE INSTRUCTIONS, AND
PRECAUTIONARY INFORMATION
Section 314 of title III of Pub. L. 99–660 directed Secretary of Health and Human Services, not later than 1
year after the effective date of this title (see Effective
Date note above) and after consultation with Advisory
Commission on Childhood Vaccines and with other appropriate entities, to review the warnings, use instructions, and precautionary information presently issued
by manufacturers of vaccines set forth in the Vaccine
Injury Table set out in section 300aa–14 of this title and
by rule determine whether such warnings, instructions,
and information adequately warn health care providers
of the nature and extent of dangers posed by such vaccines, and, if any such warning, instruction, or information is determined to be inadequate for such purpose
in any respect, require at the same time that the manufacturers revise and reissue such warning, instruction,

§ 300aa–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or information as expeditiously as practical, but not
later than 18 months after the effective date of this
title.
STUDY OF IMPACT ON SUPPLY OF VACCINES
Pub. L. 99–660, title III, § 316, Nov. 14, 1986, 100 Stat.
3786, provided that: ‘‘On June 30, 1987, and on June 30 of
each second year thereafter, the Secretary of Health
and Human Services shall submit to the Committee on
Energy and Commerce of the House of Representatives
and the Committee on Labor and Human Resources
[now Committee on Health, Education, Labor, and Pensions] of the Senate—
‘‘(1) an assessment of the impact of the amendments made by this title [enacting this subchapter,
amending sections 218, 242c, 262, 286, and 289f of this
title, redesignating former sections 300aa to 300aa–15
of this title as sections 300cc to 300cc–15 of this title,
and enacting provisions set out as notes under this
section and sections 201 and 300aa–1 of this title] on
the supply of vaccines listed in the Vaccine Injury
Table under section 2114 of the Public Health Service
Act [section 300aa–14 of this title], and
‘‘(2) an assessment of the ability of the administrators of vaccines (including public clinics and private
administrators) to provide such vaccines to children.’’
WAIVER OF PAPERWORK REDUCTION
Section 321 of title III of Pub. L. 99–660 provided that:
‘‘Chapter 35 of title 44, United States Code, shall not
apply to information required for purposes of carrying
out this title and implementing the amendments made
by this title [enacting this subchapter, amending sections 218, 242c, 262, 286, and 289f of this title, redesignating former sections 300aa to 300aa–15 of this title as sections 300cc to 300cc–15 of this title, and enacting provisions set out as notes under sections 201, 300aa–1, and
300aa–4 of this title].’’

§ 300aa–2. Program responsibilities
(a) The Director of the Program shall have the
following responsibilities:
(1) Vaccine research
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction for research carried out in or through the National
Institutes of Health, the Centers for Disease
Control and Prevention, the Office of Biologics
Research and Review of the Food and Drug Administration, the Department of Defense, and
the Agency for International Development on
means to induce human immunity against
naturally occurring infectious diseases and to
prevent adverse reactions to vaccines.
(2) Vaccine development
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction for activities carried out in or through the National
Institutes of Health, the Office of Biologics
Research and Review of the Food and Drug Administration, the Department of Defense, and
the Agency for International Development to
develop the techniques needed to produce safe
and effective vaccines.
(3) Safety and efficacy testing of vaccines
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction for
safety and efficacy testing of vaccines carried
out in or through the National Institutes of

Page 1140

Health, the Centers for Disease Control and
Prevention, the Office of Biologics Research
and Review of the Food and Drug Administration, the Department of Defense, and the
Agency for International Development.
(4) Licensing of vaccine manufacturers and
vaccines
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction for the
allocation of resources in the implementation
of the licensing program under section 263a of
this title.
(5) Production and procurement of vaccines
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, ensure that the governmental and nongovernmental production and procurement of
safe and effective vaccines by the Public
Health Service, the Department of Defense,
and the Agency for International Development
meet the needs of the United States population and fulfill commitments of the United
States to prevent human infectious diseases in
other countries.
(6) Distribution and use of vaccines
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction to the
Centers for Disease Control and Prevention
and assistance to States, localities, and health
practitioners in the distribution and use of
vaccines, including efforts to encourage public
acceptance of immunizations and to make
health practitioners and the public aware of
potential adverse reactions and contraindications to vaccines.
(7) Evaluating the need for and the effectiveness and adverse effects of vaccines and
immunization activities
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, coordinate and provide direction to the
National Institutes of Health, the Centers for
Disease Control and Prevention, the Office of
Biologics Research and Review of the Food
and Drug Administration, the National Center
for Health Statistics, the National Center for
Health Services Research and Health Care
Technology Assessment, and the Centers for
Medicare & Medicaid Services in monitoring
the need for and the effectiveness and adverse
effects of vaccines and immunization activities.
(8) Coordinating governmental and non-governmental activities
The Director of the Program shall, through
the plan issued under section 300aa–3 of this
title, provide for the exchange of information
between Federal agencies involved in the implementation of the Program and non-governmental entities engaged in the development
and production of vaccines and in vaccine research and encourage the investment of nongovernmental resources complementary to the
governmental activities under the Program.
(9) Funding of Federal agencies
The Director of the Program shall make
available to Federal agencies involved in the

Page 1141

TITLE 42—THE PUBLIC HEALTH AND WELFARE

implementation of the plan issued under section 300aa–3 of this title funds appropriated
under section 300aa–6 of this title to supplement the funds otherwise available to such
agencies for activities under the plan.
(b) In carrying out subsection (a) of this section and in preparing the plan under section
300aa–3 of this title, the Director shall consult
with all Federal agencies involved in research
on and development, testing, licensing, production, procurement, distribution, and use of vaccines.
(July 1, 1944, ch. 373, title XXI, § 2102, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3756; amended Pub. L. 102–531, title III,
§ 312(d)(13), Oct. 27, 1992, 106 Stat. 3505; Pub. L.
108–173, title IX, § 900(e)(2)(F), Dec. 8, 2003, 117
Stat. 2372.)
PRIOR PROVISIONS
A prior section 300aa–2, act July 1, 1944, § 2103, was
successively renumbered by subsequent acts and transferred, see section 238b of this title.
A prior section 2102 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238a of this title.
AMENDMENTS
2003—Subsec. (a)(7). Pub. L. 108–173 substituted ‘‘Centers for Medicare & Medicaid Services’’ for ‘‘Health
Care Financing Administration’’.
1992—Subsec. (a)(1), (3), (6), (7). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’
for ‘‘Centers for Disease Control’’.
GRANTS FOR RESEARCH ON VACCINE AGAINST VALLEY
FEVER
Pub. L. 109–432, div. B, title IV, § 402, Dec. 20, 2006, 120
Stat. 2994, provided that:
‘‘(a) IN GENERAL.—In supporting research on the development of vaccines against human diseases, the Secretary of Health and Human Services shall make grants
for the purpose of conducting research toward the development of a vaccine against coccidioidomycosis
(commonly known as Valley Fever).
‘‘(b) SUNSET.—No grant may be made under subsection (a) on or after October 1, 2012. The preceding
sentence does not have any legal effect on payments
under grants for which amounts appropriated under
subsection (c) were obligated prior to such date.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making grants under subsection (a), there are
authorized to be appropriated $40,000,000 for the period
of fiscal years 2007 through 2012.’’
DEMONSTRATION PROJECTS FOR OUTREACH PROGRAMS
Pub. L. 101–502, § 2(b), Nov. 3, 1990, 104 Stat. 1285, provided that:
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the
Centers for Disease Control, may make grants to public
and nonprofit private entities for the purpose of carrying out demonstration projects—
‘‘(A) to provide, without charge, immunizations
against vaccine-preventable diseases to children not
more than 2 years of age who reside in communities
whose population includes a significant number of
low-income individuals; and
‘‘(B) to provide outreach services to identify such
children and to inform the parents (or other guardians) of the children of the availability from the entities of the immunizations specified in subparagraph
(A).
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 1991 through 1993.’’

§ 300aa–4

[Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.]
SUPPLY OF VACCINES
Pub. L. 101–502, § 3, Nov. 3, 1990, 104 Stat. 1285, provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the
Centers for Disease Control, shall acquire and maintain
a supply of vaccines sufficient to provide vaccinations
throughout a 6-month period. Any proceeds received by
the Secretary from the sale of vaccines from such supply shall be available to the Secretary for the purpose
of purchasing vaccines for the supply. Such proceeds
shall remain available for such purpose until expended.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out subsection (a), there are authorized to be appropriated $5,000,000 for fiscal year
1991, and such sums as may be necessary for each of the
fiscal years 1992 through 1995.’’
[Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.]
Pub. L. 100–177, title I, § 110(b), Dec. 1, 1987, 101 Stat.
991, provided that:
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the
Centers for Disease Control, shall acquire and maintain
a supply of vaccines sufficient to provide vaccinations
throughout a 6-month period.
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out paragraph
(1) $5,000,000 for fiscal year 1988, and such sums as may
be necessary for each of the fiscal years 1989 and 1990.’’
[Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.]

§ 300aa–3. Plan
The Director of the Program shall prepare and
issue a plan for the implementation of the responsibilities of the Director under section
300aa–2 of this title. The plan shall establish priorities in research and the development, testing,
licensing, production, procurement, distribution, and effective use of vaccines, describe an
optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination
with the Program and in conformity with such
priorities. The first plan under this section shall
be prepared not later than January 1, 1987, and
shall be revised not later than January 1 of each
succeeding year.
(July 1, 1944, ch. 373, title XXI, § 2103, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3757.)
PRIOR PROVISIONS
A prior section 300aa–3, act July 1, 1944, § 2104, which
was renumbered section 2304 by Pub. L. 99–660, was
transferred to section 300cc–3 of this title, prior to repeal by Pub. L. 98–621, § 10(s), Nov. 8, 1984, 98 Stat. 3381.
A prior section 2103 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238b of this title.

§ 300aa–4. Repealed. Pub. L. 105–362, title VI,
§ 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285
Section, act July 1, 1944, ch. 373, title XXI, § 2104, as
added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3757, related to national vaccine program report.
A prior section 300aa–4, act July 1, 1944, § 2105, was repealed by Pub. L. 99–117, § 12(f), Oct. 7, 1985, 99 Stat. 495.
See section 300cc–4 of this title.

§ 300aa–5

TITLE 42—THE PUBLIC HEALTH AND WELFARE

A prior section 2104 of act July 1, 1944, was renumbered section 2304 by Pub. L. 99–660 and classified to
section 300cc–3 of this title, and was repealed by Pub.
L. 98–621, § 10(s), Nov. 8, 1984, 98 Stat. 3381.

§ 300aa–5. National Vaccine Advisory Committee
(a) There is established the National Vaccine
Advisory Committee. The members of the Committee shall be appointed by the Director of the
Program, in consultation with the National
Academy of Sciences, from among individuals
who are engaged in vaccine research or the manufacture of vaccines or who are physicians,
members of parent organizations concerned with
immunizations, or representatives of State or
local health agencies or public health organizations.
(b) The Committee shall—
(1) study and recommend ways to encourage
the availability of an adequate supply of safe
and effective vaccination products in the
States,
(2) recommend research priorities and other
measures the Director of the Program should
take to enhance the safety and efficacy of vaccines,
(3) advise the Director of the Program in the
implementation of sections 300aa–2, 300aa–3,
and 300aa–4 1 of this title, and
(4) identify annually for the Director of the
Program the most important areas of government and non-government cooperation that
should be considered in implementing sections
300aa–2, 300aa–3, and 300aa–4 1 of this title.

appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.
(b) To carry out section 300aa–2(9) of this title
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 2004 and 2005.
(July 1, 1944, ch. 373, title XXI, § 2106, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3758; amended Pub. L. 101–502, § 4, Nov. 3,
1990, 104 Stat. 1286; Pub. L. 108–276, § 2(c), July 21,
2004, 118 Stat. 842.)
PRIOR PROVISIONS
A prior section 300aa–6, act July 1, 1944, § 2107, was
successively renumbered by subsequent acts and transferred, see section 238d of this title.
A prior section 2106 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238c of this title.
Prior sections 300aa–7 to 300aa–9, act July 1, 1944,
§§ 2108–2110, respectively, were successively renumbered
by subsequent acts and transferred, see sections 238e to
238g, respectively, of this title.
AMENDMENTS
2004—Pub. L. 108–276 substituted provisions authorizing appropriations for fiscal years 2004 and 2005 for provisions authorizing appropriations for fiscal years 1991
through 1995 in subsecs. (a) and (b).
1990—Pub. L. 101–502 substituted provisions authorizing appropriations for fiscal years 1991 through 1995 for
provisions authorizing appropriations for fiscal years
1987 through 1991 in subsecs. (a) and (b).

PART 2—NATIONAL VACCINE INJURY
COMPENSATION PROGRAM

(July 1, 1944, ch. 373, title XXI, § 2105, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3758.)
REFERENCES IN TEXT
Section 300aa–4 of this title, referred to in subsec.
(b)(3), (4), was repealed by Pub. L. 105–362, title VI,
§ 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285.
PRIOR PROVISIONS
A prior section 300aa–5, act July 1, 1944, § 2106, was
successively renumbered by subsequent acts and transferred, see section 238c of this title.
A prior section 2105 of act July 1, 1944, was repealed
by Pub. L. 99–117, § 12(f), Oct. 7, 1985, 99 Stat. 495. See
section 300cc–4 of this title.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 300aa–6. Authorization of appropriations
(a) To carry out this part other than section
300aa–2(9) of this title there are authorized to be
1 See

References in Text note below.

Page 1142

SUBPART A—PROGRAM REQUIREMENTS

§ 300aa–10. Establishment of program
(a) Program established
There is established the National Vaccine Injury Compensation Program to be administered
by the Secretary under which compensation
may be paid for a vaccine-related injury or
death.
(b) Attorney’s obligation
It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that compensation may be
available under the program 1 for such injury or
death.
(c) Publicity
The Secretary shall undertake reasonable efforts to inform the public of the availability of
the Program.
(July 1, 1944, ch. 373, title XXI, § 2110, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3758; amended Pub. L. 101–239, title VI,
§ 6601(b), Dec. 19, 1989, 103 Stat. 2285.)
PRIOR PROVISIONS
A prior section 300aa–10, act July 1, 1944, § 2111, was
successively renumbered by subsequent acts and transferred, see section 238h of this title.
A prior section 2110 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238g of this title.
1 So

in original. Probably should be capitalized.

Page 1143

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1989—Subsec. (c). Pub. L. 101–239 added subsec. (c).
EFFECTIVE DATE OF 1989 AMENDMENT
Section 6601(s) of Pub. L. 101–239, as amended by Pub.
L. 102–572, title IX, § 902(b)(1), Oct. 29, 1992, 106 Stat.
4516, provided that:
‘‘(1) Except as provided in paragraph (2), the amendments made by this section [amending this section and
sections 300aa–11 to 300aa–17, 300aa–21, 300aa–23,
300aa–26, and 300aa–27 of this title] shall apply as follows:
‘‘(A) Petitions filed after the date of enactment of
this section [Dec. 19, 1989] shall proceed under the National Vaccine Injury Compensation Program under
title XXI of the Public Health Service Act [this subchapter] as amended by this section.
‘‘(B) Petitions currently pending in which the evidentiary record is closed shall continue to proceed
under the Program in accordance with the law in effect before the date of the enactment of this section,
except that if the United States Court of Federal
Claims is to review the findings of fact and conclusions of law of a special master on such a petition,
the court may receive further evidence in conducting
such review.
‘‘(C) Petitions currently pending in which the evidentiary record is not closed shall proceed under the
Program in accordance with the law as amended by
this section.
All pending cases which will proceed under the Program as amended by this section shall be immediately
suspended for 30 days to enable the special masters and
parties to prepare for proceeding under the Program as
amended by this section. In determining the 240-day period prescribed by section 2112(d) of the Public Health
Service Act [42 U.S.C. 300aa–12(d)], as amended by this
section, or the 420-day period prescribed by section
2121(b) of such Act [42 U.S.C. 300aa–21(b)], as so amended, any period of suspension under the preceding sentence shall be excluded.
‘‘(2) The amendments to section 2115 of the Public
Health Service Act [42 U.S.C. 300aa–15] shall apply to
all pending and subsequently filed petitions.’’
EFFECTIVE DATE
Subpart effective Oct. 1, 1988, see section 323 of Pub.
L. 99–660, as amended, set out as a note under section
300aa–1 of this title.

§ 300aa–11. Petitions for compensation
(a) General rule
(1) A proceeding for compensation under the
Program for a vaccine-related injury or death
shall be initiated by service upon the Secretary
and the filing of a petition containing the matter prescribed by subsection (c) of this section
with the United States Court of Federal Claims.
The clerk of the United States Court of Federal
Claims shall immediately forward the filed petition to the chief special master for assignment
to a special master under section 300aa–12(d)(1)
of this title.
(2)(A) No person may bring a civil action for
damages in an amount greater than $1,000 or in
an unspecified amount against a vaccine administrator or manufacturer in a State or Federal
court for damages arising from a vaccine-related
injury or death associated with the administration of a vaccine after October 1, 1988, and no
such court may award damages in an amount
greater than $1,000 in a civil action for damages
for such a vaccine-related injury or death, unless a petition has been filed, in accordance with
section 300aa–16 of this title, for compensation

§ 300aa–11

under the Program for such injury or death
and—
(i)(I) the United States Court of Federal
Claims has issued a judgment under section
300aa–12 of this title on such petition, and
(II) such person elects under section
300aa–21(a) of this title to file such an action,
or
(ii) such person elects to withdraw such petition under section 300aa–21(b) of this title or
such petition is considered withdrawn under
such section.
(B) If a civil action which is barred under subparagraph (A) is filed in a State or Federal
court, the court shall dismiss the action. If a petition is filed under this section with respect to
the injury or death for which such civil action
was brought, the date such dismissed action was
filed shall, for purposes of the limitations of actions prescribed by section 300aa–16 of this title,
be considered the date the petition was filed if
the petition was filed within one year of the
date of the dismissal of the civil action.
(3) No vaccine administrator or manufacturer
may be made a party to a civil action (other
than a civil action which may be brought under
paragraph (2)) for damages for a vaccine-related
injury or death associated with the administration of a vaccine after October 1, 1988.
(4) If in a civil action brought against a vaccine administrator or manufacturer before October 1, 1988, damages were denied for a vaccine-related injury or death or if such civil action was
dismissed with prejudice, the person who
brought such action may file a petition under
subsection (b) of this section for such injury or
death.
(5)(A) A plaintiff who on October 1, 1988, has
pending a civil action for damages for a vaccinerelated injury or death may, at any time within
2 years after October 1, 1988, or before judgment,
whichever occurs first, petition to have such action dismissed without prejudice or costs and
file a petition under subsection (b) of this section for such injury or death.
(B) If a plaintiff has pending a civil action for
damages for a vaccine-related injury or death,
such person may not file a petition under subsection (b) of this section for such injury or
death.
(6) If a person brings a civil action after November 15, 1988 for damages for a vaccine-related
injury or death associated with the administration of a vaccine before November 15, 1988, such
person may not file a petition under subsection
(b) of this section for such injury or death.
(7) If in a civil action brought against a vaccine administrator or manufacturer for a vaccine-related injury or death damages are awarded under a judgment of a court or a settlement
of such action, the person who brought such action may not file a petition under subsection (b)
of this section for such injury or death.
(8) If on October 1, 1988, there was pending an
appeal or rehearing with respect to a civil action brought against a vaccine administrator or
manufacturer and if the outcome of the last appellate review of such action or the last rehearing of such action is the denial of damages for a
vaccine-related injury or death, the person who
brought such action may file a petition under

§ 300aa–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

subsection (b) of this section for such injury or
death.
(9) This subsection applies only to a person
who has sustained a vaccine-related injury or
death and who is qualified to file a petition for
compensation under the Program.
(10) The Clerk of the United States Claims
Court 2 is authorized to continue to receive, and
forward, petitions for compensation for a vaccine-related injury or death associated with the
administration of a vaccine on or after October
1, 1992.
(b) Petitioners
(1)(A) Except as provided in subparagraph (B),
any person who has sustained a vaccine-related
injury, the legal representative of such person if
such person is a minor or is disabled, or the
legal representative of any person who died as
the result of the administration of a vaccine set
forth in the Vaccine Injury Table may, if the
person meets the requirements of subsection
(c)(1) of this section, file a petition for compensation under the Program.
(B) No person may file a petition for a vaccinerelated injury or death associated with a vaccine administered before October 1, 1988, if compensation has been paid under this part for 3500
petitions for such injuries or deaths.
(2) Only one petition may be filed with respect
to each administration of a vaccine.
(c) Petition content
A petition for compensation under the Program for a vaccine-related injury or death shall
contain—
(1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the person who suffered such
injury or who died—
(A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not
receive such a vaccine, contracted polio, directly or indirectly, from another person
who received an oral polio vaccine,
(B)(i) if such person received a vaccine set
forth in the Vaccine Injury Table—
(I) received the vaccine in the United
States or in its trust territories,
(II) received the vaccine outside the
United States or a trust territory and at
the time of the vaccination such person
was a citizen of the United States serving
abroad as a member of the Armed Forces
or otherwise as an employee of the United
States or a dependent of such a citizen, or
(III) received the vaccine outside the
United States or a trust territory and the
vaccine was manufactured by a vaccine
manufacturer located in the United States
and such person returned to the United
States not later than 6 months after the
date of the vaccination,
(ii) if such person did not receive such a
vaccine but contracted polio from another
person who received an oral polio vaccine,
was a citizen of the United States or a dependent of such a citizen,
(C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or con2 See

Change of Name note below.

Page 1144

dition set forth in the Vaccine Injury Table
in association with the vaccine referred to in
subparagraph (A) or died from the administration of such vaccine, and the first symptom or manifestation of the onset or of the
significant aggravation of any such illness,
disability, injury, or condition or the death
occurred within the time period after vaccine administration set forth in the Vaccine
Injury Table, or
(ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or
condition not set forth in the Vaccine Injury
Table but which was caused by a vaccine referred to in subparagraph (A), or
(II) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table
the first symptom or manifestation of the
onset or significant aggravation of which did
not occur within the time period set forth in
the Table but which was caused by a vaccine
referred to in subparagraph (A),
(D)(i) suffered the residual effects or complications of such illness, disability, injury,
or condition for more than 6 months after
the administration of the vaccine, or (ii)
died from the administration of the vaccine,
or (iii) suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention, and
(E) has not previously collected an award
or settlement of a civil action for damages
for such vaccine-related injury or death,
(2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn
hospital records (including all physicians’ and
nurses’ notes and test results), vaccination
records associated with the vaccine allegedly
causing the injury, pre- and post-injury physician or clinic records (including all relevant
growth charts and test results), all post-injury
inpatient and outpatient records (including all
provider notes, test results, and medication
records), if applicable, a death certificate, and
if applicable, autopsy results, and
(3) an identification of any records of the
type described in paragraph (1) or (2) which are
unavailable to the petitioner and the reasons
for their unavailability.
(d) Additional information
A petition may also include other available
relevant medical records relating to the person
who suffered such injury or who died from the
administration of the vaccine.
(e) Schedule
The petitioner shall submit in accordance
with a schedule set by the special master assigned to the petition assessments, evaluations,
and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be
paid to, or on behalf of, the person who suffered
such injury or who died from the administration
of the vaccine.
(July 1, 1944, ch. 373, title XXI, § 2111, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3758; amended Pub. L. 100–203, title IV,

Page 1145

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§§ 4302(b), 4304(a), (b), 4306, 4307(1), (2), Dec. 22,
1987, 101 Stat. 1330–221, 1330–223, 1330–224; Pub. L.
101–239, title VI, § 6601(c)(1)–(7), Dec. 19, 1989, 103
Stat. 2285, 2286; Pub. L. 101–502, § 5(a), Nov. 3,
1990, 104 Stat. 1286; Pub. L. 102–168, title II,
§ 201(h)(1), Nov. 26, 1991, 105 Stat. 1104; Pub. L.
102–572, title IX, § 902(b)(1), Oct. 29, 1992, 106 Stat.
4516; Pub. L. 103–43, title XX, § 2012, June 10, 1993,
107 Stat. 214; Pub. L. 105–277, div. C, title XV,
§ 1502, Oct. 21, 1998, 112 Stat. 2681–741; Pub. L.
106–310, div. A, title XVII, § 1701(a), Oct. 17, 2000,
114 Stat. 1151.)
CODIFICATION
In subsecs. (a)(2)(A), (3), (4), (5)(A), (8), and (b)(1)(B),
‘‘October 1, 1988’’ substituted for ‘‘the effective date of
this subpart’’ on authority of section 323 of Pub. L.
99–660, as amended, set out as an Effective Date note
under section 300aa–1 of this title.
PRIOR PROVISIONS
A prior section 300aa–11, act July 1, 1944, § 2112, was
successively renumbered by subsequent acts and transferred, see section 238i of this title.
A prior section 2111 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238h of this title.
AMENDMENTS
2000—Subsec. (c)(1)(D)(iii). Pub. L. 106–310 added cl.
(iii).
1998—Subsec. (c)(1)(D)(i). Pub. L. 105–277 struck out
‘‘and incurred unreimbursable expenses due in whole or
in part to such illness, disability, injury, or condition
in an amount greater than $1,000’’ before ‘‘, or (ii)
died’’.
1993—Subsec. (a)(10). Pub. L. 103–43 added par. (10).
1992—Subsec. (a)(1), (2)(A)(i)(I). Pub. L. 102–572 substituted ‘‘United States Court of Federal Claims’’ for
‘‘United States Claims Court’’ wherever appearing.
1991—Subsec. (a)(2)(A)(i), (ii). Pub. L. 102–168 realigned margins of cls. (i) and (ii).
1990—Subsec. (a)(2)(A). Pub. L. 101–502, § 5(a)(1), substituted ‘‘unless a petition has been filed, in accordance
with section 300aa–16 of this title, for compensation
under the Program for such injury or death and—’’ and
cls. (i) and (ii) for ‘‘unless—
‘‘(i) a petition has been filed, in accordance with
section 300aa–16 of this title, for compensation under
the Program for such injury or death,
‘‘(ii) the United States Claims Court has issued a
judgment under section 300aa–12 of this title on such
petition, and
‘‘(iii) such person elects under section 300aa–21(a) of
this title to file such an action.’’
Subsec. (a)(5)(A). Pub. L. 101–502, § 5(a)(2), struck out
‘‘without prejudice’’ after ‘‘without prejudice or costs’’.
Subsec. (a)(5)(B). Pub. L. 101–502, § 5(a)(3), substituted
‘‘plaintiff’’ for ‘‘plaintiff who’’.
Subsec. (d). Pub. L. 101–502, § 5(a)(4), struck out ‘‘(d)
except as provided in paragraph (3),’’ before ‘‘(d) Additional information’’.
Subsec. (e). Pub. L. 101–502, § 5(a)(5), substituted ‘‘(e)
Schedule’’ for ‘‘(e)(e) Schedule’’.
1989—Subsec. (a)(1). Pub. L. 101–239, § 6601(c)(1), substituted ‘‘filing of a petition containing the matter prescribed in subsection (c) of this section’’ for ‘‘filing of
a petition’’ and inserted at end ‘‘The clerk of the
United States Claims Court shall immediately forward
the filed petition to the chief special master for assignment to a special master under section 300aa–12(d)(1) of
this title.’’
Subsec. (a)(2)(A)(i). Pub. L. 101–239, § 6601(c)(2), struck
out ‘‘under subsection (b) of this section’’ after ‘‘section 300aa–16 of this title,’’.
Subsec. (a)(5)(A). Pub. L. 101–239, § 6601(c)(3)(A), substituted ‘‘petition to have such action dismissed without prejudice or costs’’ for ‘‘elect to withdraw such action’’.

§ 300aa–11

Subsec. (a)(5)(B). Pub. L. 101–239, § 6601(c)(3)(B), substituted ‘‘has pending’’ for ‘‘on October 1, 1988, had
pending’’ and struck out ‘‘does not withdraw the action
under subparagraph (A)’’ after ‘‘vaccine-related injury
or death’’.
Subsec. (a)(6). Pub. L. 101–239, § 6601(c)(4), substituted
‘‘November 15, 1988’’ for ‘‘the effective date of this subpart’’ in two places.
Subsec. (a)(8). Pub. L. 101–239, § 6601(c)(5), added par.
(8). Former par. (8) redesignated (9).
Subsec. (a)(9). Pub. L. 101–239, § 6601(c)(5), (7), redesignated par. (8) as (9) and realigned margin.
Subsec. (c)(1). Pub. L. 101–239, § 6601(c)(6)(A), inserted
‘‘except as provided in paragraph (3),’’ after ‘‘(1)’’ in introductory provisions.
Subsec. (c)(2). Pub. L. 101–239, § 6601(c)(6)(B), (C),
added par. (2) and redesignated former par. (2) as subsec. (d).
Pub. L. 101–239, § 6601(c)(6)(A), inserted ‘‘except as provided in paragraph (3),’’ after ‘‘(2)’’.
Subsec. (c)(3). Pub. L. 101–239, § 6601(c)(6)(C), (D),
added par. (3). Former par. (3) redesignated subsec. (e).
Subsec. (d). Pub. L. 101–239, § 6601(c)(6)(B), redesignated former subsec. (c)(2) as subsec. (d), expanded margin to full measure, inserted subsec. designation and
heading, substituted ‘‘A petition may also include
other available’’ for ‘‘all available’’, struck out ‘‘(including autopsy reports, if any)’’ after ‘‘relevant medical records’’, and substituted ‘‘administration of the
vaccine.’’ for ‘‘administration of the vaccine and an
identification of any unavailable records known to the
petitioner and the reasons for their unavailability,
and’’.
Subsec. (e). Pub. L. 101–239, § 6601(c)(6)(D), redesignated former subsec. (c)(3) as subsec. (e), expanded margin to full measure, inserted subsec. designation and
heading, and substituted ‘‘The petitioner shall submit
in accordance with a schedule set by the special master
assigned to the petition’’ for ‘‘appropriate’’.
1987—Subsec. (a)(1). Pub. L. 100–203, § 4307(1), which directed that par. (1) be amended by substituting ‘‘with
the United States Claims Court’’ for ‘‘with the United
States district court for the district in which the petitioner resides or the injury or death occurred’’, was executed making the substitution for ‘‘with the United
States district court for the district in which the petitioner resides or in which the injury or death occurred’’, as the probable intent of Congress.
Subsec. (a)(2)(A). Pub. L. 100–203, § 4306, substituted
‘‘vaccine administrator or manufacturer’’ for ‘‘vaccine
manufacturer’’.
Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date
of this subpart’’ for ‘‘effective date of this part’’.
Subsec. (a)(2)(A)(ii). Pub. L. 100–203, § 4307(2), substituted ‘‘the United States Claims Court’’ for ‘‘a district court of the United States’’.
Subsec. (a)(3). Pub. L. 100–203, § 4306, substituted ‘‘vaccine administrator or manufacturer’’ for ‘‘vaccine manufacturer’’.
Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date
of this subpart’’ for ‘‘effective date of this part’’.
Subsec. (a)(4). Pub. L. 100–203, § 4306, substituted ‘‘vaccine administrator or manufacturer’’ for ‘‘vaccine manufacturer’’.
Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date
of this subpart’’ for ‘‘effective date of this part’’.
Subsec. (a)(5)(A). Pub. L. 100–203, § 4302(b)(2), substituted ‘‘after the effective date of this subpart’’ for
‘‘after the effective date of this subchapter’’.
Pub. L. 100–203, § 4302(b)(1), substituted ‘‘who on the
effective date of this subpart’’ for ‘‘who on the effective
date of this part’’.
Subsec. (a)(5)(B). Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date of this subpart’’ for ‘‘effective
date of this part’’.
Subsec. (a)(6). Pub. L. 100–203, § 4302(b)(1), substituted
‘‘effective date of this subpart’’ for ‘‘effective date of
this part’’ in two places.
Subsec. (a)(7). Pub. L. 100–203, § 4306, substituted ‘‘vaccine administrator or manufacturer’’ for ‘‘vaccine manufacturer’’.

§ 300aa–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a)(8). Pub. L. 100–203, § 4304(a), added par. (8).
Subsec. (b)(1)(A). Pub. L. 100–203, § 4304(b)(1), substituted ‘‘may, if the person meets the requirements of
subsection (c)(1) of this section, file’’ for ‘‘may file’’.
Subsec. (b)(1)(B). Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date of this subpart’’ for ‘‘effective
date of this part’’.
Subsec. (c)(1)(D). Pub. L. 100–203, § 4304(b)(2), substituted ‘‘for more than 6 months’’ for ‘‘for more than
1 year’’, ‘‘and incurred’’ for ‘‘, (ii) incurred’’, and ‘‘(ii)’’
for ‘‘(iii)’’.
CHANGE OF NAME
References to United States Claims Court deemed to
refer to United States Court of Federal Claims, see section 902(b) of Pub. L. 102–572, set out as a note under
section 171 of Title 28, Judiciary and Judicial Procedure.
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–310, div. A, title XVII, § 1701(b), Oct. 17,
2000, 114 Stat. 1151, provided that: ‘‘The amendment
made by subsection (a) [amending this section] takes
effect upon the date of the enactment of this Act [Oct.
17, 2000], including with respect to petitions under section 2111 of the Public Health Service Act [this section]
that are pending on such date.’’
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1991 AMENDMENT
Section 201(i) of Pub. L. 102–168 provided that:
‘‘(1) Except as provided in paragraph (2), the amendments made by this section [amending this section and
sections 300aa–12, 300aa–15, 300aa–16, 300aa–19, and
300aa–21 of this title and provisions set out as a note
under section 300aa–1 of this title] shall take effect on
the date of the enactment of this Act [Nov. 26, 1991].
‘‘(2) The amendments made by subsections (d) and (f)
[amending sections 300aa–12, 300aa–15, 300aa–16, and
300aa–21 of this title] shall take effect as if the amendments had been in effect on and after October 1, 1988.’’
EFFECTIVE DATE OF 1990 AMENDMENT
Section 5(h) of Pub. L. 101–502 provided that: ‘‘The
amendments made by subsections (f)(1) and (g) [amending section 300aa–21 of this title and provisions set out
as a note under section 300aa–1 of this title and enacting provisions set out as a note under section 300aa–12
of this title] shall take effect as of November 14, 1986,
and the amendments made by subsections (a) through
(e) and subsection (f)(2) [amending this section and sections 300aa–12, 300aa–13, 300aa–15, 300aa–16, and 300aa–21
of this title] shall take effect as of September 30, 1990.’’
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–12. Court jurisdiction
(a) General rule
The United States Court of Federal Claims
and the United States Court of Federal Claims
special masters shall, in accordance with this
section, have jurisdiction over proceedings to
determine if a petitioner under section 300aa–11
of this title is entitled to compensation under

Page 1146

the Program and the amount of such compensation. The United States Court of Federal Claims
may issue and enforce such orders as the court
deems necessary to assure the prompt payment
of any compensation awarded.
(b) Parties
(1) In all proceedings brought by the filing of
a petition under section 300aa–11(b) of this title,
the Secretary shall be named as the respondent,
shall participate, and shall be represented in accordance with section 518(a) of title 28.
(2) Within 30 days after the Secretary receives
service of any petition filed under section
300aa–11 of this title the Secretary shall publish
notice of such petition in the Federal Register.
The special master designated with respect to
such petition under subsection (c) of this section
shall afford all interested persons an opportunity to submit relevant, written information—
(A) relating to the existence of the evidence
described in section 300aa–13(a)(1)(B) of this
title, or
(B) relating to any allegation in a petition
with respect to the matters described in section 300aa–11(c)(1)(C)(ii) of this title.
(c) United States Court of Federal Claims special
masters
(1) There is established within the United
States Court of Federal Claims an office of special masters which shall consist of not more
than 8 special masters. The judges of the United
States Court of Federal Claims shall appoint the
special masters, 1 of whom, by designation of
the judges of the United States Court of Federal
Claims, shall serve as chief special master. The
appointment and reappointment of the special
masters shall be by the concurrence of a majority of the judges of the court.
(2) The chief special master and other special
masters shall be subject to removal by the
judges of the United States Court of Federal
Claims for incompetency, misconduct, or neglect of duty or for physical or mental disability
or for other good cause shown.
(3) A special master’s office shall be terminated if the judges of the United States Court of
Federal Claims determine, upon advice of the
chief special master, that the services performed
by that office are no longer needed.
(4) The appointment of any individual as a special master shall be for a term of 4 years, subject to termination under paragraphs (2) and (3).
Individuals serving as special masters on December 19, 1989, shall serve for 4 years from the
date of their original appointment, subject to
termination under paragraphs (2) and (3). The
chief special master in office on December 19,
1989, shall continue to serve as chief special
master for the balance of the master’s term,
subject to termination under paragraphs (2) and
(3).
(5) The compensation of the special masters
shall be determined by the judges of the United
States Court of Federal Claims, upon advice of
the chief special master. The salary of the chief
special master shall be the annual rate of basic
pay for level IV of the Executive Schedule, as
prescribed by section 5315, title 5. The salaries of
the other special masters shall not exceed the

Page 1147

TITLE 42—THE PUBLIC HEALTH AND WELFARE

annual rate of basic pay of level V of the Executive Schedule, as prescribed by section 5316, title
5.
(6) The chief special master shall be responsible for the following:
(A) Administering the office of special masters and their staff, providing for the efficient,
expeditious, and effective handling of petitions, and performing such other duties related to the Program as may be assigned to the
chief special master by a concurrence of a majority of the United States Claims Courts 1
judges.
(B) Appointing and fixing the salary and duties of such administrative staff as are necessary. Such staff shall be subject to removal
for good cause by the chief special master.
(C) Managing and executing all aspects of
budgetary and administrative affairs affecting
the special masters and their staff, subject to
the rules and regulations of the Judicial Conference of the United States. The Conference
rules and regulations pertaining to United
States magistrate judges shall be applied to
the special masters.
(D) Coordinating with the United States
Court of Federal Claims the use of services,
equipment, personnel, information, and facilities of the United States Court of Federal
Claims without reimbursement.
(E) Reporting annually to the Congress and
the judges of the United States Court of Federal Claims on the number of petitions filed
under section 300aa–11 of this title and their
disposition, the dates on which the vaccine-related injuries and deaths for which the petitions were filed occurred, the types and
amounts of awards, the length of time for the
disposition of petitions, the cost of administering the Program, and recommendations
for changes in the Program.
(d) Special masters
(1) Following the receipt and filing of a petition under section 300aa–11 of this title, the
clerk of the United States Court of Federal
Claims shall forward the petition to the chief
special master who shall designate a special
master to carry out the functions authorized by
paragraph (3).
(2) The special masters shall recommend rules
to the Court of Federal Claims and, taking into
account such recommended rules, the Court of
Federal Claims shall promulgate rules pursuant
to section 2071 of title 28. Such rules shall—
(A) provide for a less-adversarial, expeditious, and informal proceeding for the resolution of petitions,
(B) include flexible and informal standards
of admissibility of evidence,
(C) include the opportunity for summary
judgment,
(D) include the opportunity for parties to
submit arguments and evidence on the record
without requiring routine use of oral presentations, cross examinations, or hearings, and
(E) provide for limitations on discovery and
allow the special masters to replace the usual
1 So in original. Probably should be a reference to the United
States Court of Federal Claims.

§ 300aa–12

rules of discovery in civil actions in the
United States Court of Federal Claims.
(3)(A) A special master to whom a petition has
been assigned shall issue a decision on such petition with respect to whether compensation is to
be provided under the Program and the amount
of such compensation. The decision of the special master shall—
(i) include findings of fact and conclusions of
law, and
(ii) be issued as expeditiously as practicable
but not later than 240 days, exclusive of suspended time under subparagraph (C), after the
date the petition was filed.
The decision of the special master may be reviewed by the United States Court of Federal
Claims in accordance with subsection (e) of this
section.
(B) In conducting a proceeding on a petition a
special master—
(i) may require such evidence as may be reasonable and necessary,
(ii) may require the submission of such information as may be reasonable and necessary,
(iii) may require the testimony of any person and the production of any documents as
may be reasonable and necessary,
(iv) shall afford all interested persons an opportunity to submit relevant written information—
(I) relating to the existence of the evidence
described in section 300aa–13(a)(1)(B) of this
title, or
(II) relating to any allegation in a petition
with respect to the matters described in section 300aa–11(c)(1)(C)(ii) of this title, and
(v) may conduct such hearings as may be
reasonable and necessary.
There may be no discovery in a proceeding on a
petition other than the discovery required by
the special master.
(C) In conducting a proceeding on a petition a
special master shall suspend the proceedings one
time for 30 days on the motion of either party.
After a motion for suspension is granted, further
motions for suspension by either party may be
granted by the special master, if the special
master determines the suspension is reasonable
and necessary, for an aggregate period not to exceed 150 days.
(D) If, in reviewing proceedings on petitions
for vaccine-related injuries or deaths associated
with the administration of vaccines before October 1, 1988, the chief special master determines
that the number of filings and resultant workload place an undue burden on the parties or the
special master involved in such proceedings, the
chief special master may, in the interest of justice, suspend proceedings on any petition for up
to 30 months (but for not more than 6 months at
a time) in addition to the suspension time under
subparagraph (C).
(4)(A) Except as provided in subparagraph (B),
information submitted to a special master or
the court in a proceeding on a petition may not
be disclosed to a person who is not a party to
the proceeding without the express written consent of the person who submitted the information.

§ 300aa–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) A decision of a special master or the court
in a proceeding shall be disclosed, except that if
the decision is to include information—
(i) which is trade secret or commercial or financial information which is privileged and
confidential, or
(ii) which are medical files and similar files
the disclosure of which would constitute a
clearly unwarranted invasion of privacy,
and if the person who submitted such information objects to the inclusion of such information
in the decision, the decision shall be disclosed
without such information.
(e) Action by United States Court of Federal
Claims
(1) Upon issuance of the special master’s decision, the parties shall have 30 days to file with
the clerk of the United States Court of Federal
Claims a motion to have the court review the
decision. If such a motion is filed, the other
party shall file a response with the clerk of the
United States Court of Federal Claims no later
than 30 days after the filing of such motion.
(2) Upon the filing of a motion under paragraph (1) with respect to a petition, the United
States Court of Federal Claims shall have jurisdiction to undertake a review of the record of
the proceedings and may thereafter—
(A) uphold the findings of fact and conclusions of law of the special master and sustain
the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master found to be
arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law and
issue its own findings of fact and conclusions
of law, or
(C) remand the petition to the special master for further action in accordance with the
court’s direction.
The court shall complete its action on a petition
within 120 days of the filing of a response under
paragraph (1) excluding any days the petition is
before a special master as a result of a remand
under subparagraph (C). The court may allow
not more than 90 days for remands under subparagraph (C).
(3) In the absence of a motion under paragraph
(1) respecting the special master’s decision or if
the United States Court of Federal Claims takes
the action described in paragraph (2)(A) with respect to the special master’s decision, the clerk
of the United States Court of Federal Claims
shall immediately enter judgment in accordance
with the special master’s decision.
(f) Appeals
The findings of fact and conclusions of law of
the United States Court of Federal Claims on a
petition shall be final determinations of the
matters involved, except that the Secretary or
any petitioner aggrieved by the findings or conclusions of the court may obtain review of the
judgment of the court in the United States court
of appeals for the Federal Circuit upon petition
filed within 60 days of the date of the judgment
with such court of appeals within 60 days of the
date of entry of the United States Claims
Court’s 2 judgment with such court of appeals.
2 So in original. Probably should be a reference to the United
States Court of Federal Claims.

Page 1148

(g) Notice
If—
(1) a special master fails to make a decision
on a petition within the 240 days prescribed by
subsection (d)(3)(A)(ii) of this section (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D) of this section, and
(B) any days the petition is before a special
master as a result of a remand under subsection (e)(2)(C) of this section), or
(2) the United States Court of Federal
Claims fails to enter a judgment under this
section on a petition within 420 days (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D) of this section, and
(B) any days the petition is before a special
master as a result of a remand under subsection (e)(2)(C) of this section) after the date
on which the petition was filed,
the special master or court shall notify the petitioner under such petition that the petitioner
may withdraw the petition under section
300aa–21(b) of this title or the petitioner may
choose under section 300aa–21(b) of this title to
have the petition remain before the special master or court, as the case may be.
(July 1, 1944, ch. 373, title XXI, § 2112, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3761; amended Pub. L. 100–203, title IV,
§§ 4303(d)(2)(A), 4307(3), 4308(a), (b), Dec. 22, 1987,
101 Stat. 1330–222, 1330–224; Pub. L. 100–360, title
IV, § 411(o)(2), (3)(A), July 1, 1988, 102 Stat. 808;
Pub. L. 101–239, title VI, § 6601(d)–(i), Dec. 19,
1989, 103 Stat. 2286–2290; Pub. L. 101–502, § 5(b),
Nov. 3, 1990, 104 Stat. 1286; Pub. L. 101–650, title
III, § 321, Dec. 1, 1990, 104 Stat. 5117; Pub. L.
102–168, title II, § 201(c), (d)(1), (h)(2), (3), Nov. 26,
1991, 105 Stat. 1103, 1104; Pub. L. 102–572, title IX,
§ 902(b), Oct. 29, 1992, 106 Stat. 4516; Pub. L.
103–66, title XIII, § 13632(c), Aug. 10, 1993, 107
Stat. 646.)
CODIFICATION
In subsec. (c)(4), ‘‘on December 19, 1989,’’ substituted
for ‘‘upon the date of the enactment of this subsection’’
and ‘‘on the date of the enactment of this subsection’’.
In subsec. (d)(3)(D), ‘‘October 1, 1988,’’ substituted for
‘‘the effective date of this part’’.
PRIOR PROVISIONS
A prior section 300aa–12, act July 1, 1944, § 2113, was
successively renumbered by subsequent acts and transferred, see section 238j of this title.
A prior section 2112 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238i of this title.
AMENDMENTS
1993—Subsec. (d)(3)(D). Pub. L. 103–66 substituted ‘‘30
months (but for not more than 6 months at a time)’’ for
‘‘540 days’’.
1992—Subsecs. (a), (c) to (g). Pub. L. 102–572 substituted ‘‘United States Court of Federal Claims’’ for
‘‘United States Claims Court’’ and ‘‘Court of Federal
Claims’’ for ‘‘Claims Court’’, wherever appearing.
1991—Subsec. (d)(3)(D). Pub. L. 102–168, § 201(c), (h)(2),
realigned margin and substituted ‘‘540 days’’ for ‘‘180
days’’.
Subsec. (g). Pub. L. 102–168, § 201(h)(3), made technical
amendment to underlying provisions of original Act.
Pub. L. 102–168, § 201(d)(1), substituted ‘‘or the petitioner may choose under section 300aa–21(b) of this title
to have the petition remain before the special master

Page 1149

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or court, as the case may be’’ for ‘‘and the petition will
be considered withdrawn under such section if the petitioner, the special master, or the court do not take certain actions’’ before period at end.
1990—Subsec. (d)(3)(D). Pub. L. 101–502, § 5(b)(1), added
subpar. (D).
Subsec. (g). Pub. L. 101–502, § 5(b)(2), added subsec. (g).
1989—Subsec. (a). Pub. L. 101–239, § 6601(d), substituted
‘‘and the United States Claims Court special masters
shall, in accordance with this section, have jurisdiction’’ for ‘‘shall have jurisdiction (1)’’, ‘‘. The United
States Claims Court may issue’’ for ‘‘, and (2) to issue’’,
and ‘‘deems’’ for ‘‘deem’’.
Subsec. (b)(1). Pub. L. 101–239, § 6601(f), substituted ‘‘In
all proceedings brought by the filing of a petition under
section 300aa–11(b) of this title, the Secretary shall be
named as the respondent, shall participate, and shall be
represented in accordance with section 518(a) of title
28.’’ for ‘‘The Secretary shall be named as the respondent in all proceedings brought by the filing of a petition under section 300aa–11(b) of this title. Except as
provided in paragraph (2), no other person may intervene in any such proceeding.’’
Subsec. (c). Pub. L. 101–239, § 6601(e)(2), added subsec.
(c). Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 101–239, § 6601(e)(1), redesignated
subsec. (c) as (d). Former subsec. (d) redesignated (e).
Subsec. (d)(1). Pub. L. 101–239, § 6601(g)(1), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘Following receipt of a petition under subsection (a) of this section, the United States Claims
Court shall designate a special master to carry out the
functions authorized by paragraph (2).’’
Subsec. (d)(2) to (4). Pub. L. 101–239, § 6601(g)(2), added
pars. (2) to (4) and struck out former par. (2) which prescribed functions of special masters.
Subsec. (e). Pub. L. 101–239, § 6601(h), substituted ‘‘Action by United States Claims Court’’ for ‘‘Action by
court’’ as heading and amended text generally. Prior to
amendment, text read as follows:
‘‘(1) Upon objection by the petitioner or respondent
to the proposed findings of fact or conclusions of law
prepared by the special master or upon the court’s own
motion, the court shall undertake a review of the
record of the proceedings and may thereafter make a de
novo determination of any matter and issue its judgment accordingly, including findings of fact and conclusions of law, or remand for further proceedings.
‘‘(2) If no objection is filed under paragraph (1) or if
the court does not choose to review the proceeding, the
court shall adopt the proposed findings of fact and conclusions of law of the special master as its own and
render judgment thereon.
‘‘(3) The court shall render its judgment on any petition filed under the Program as expeditiously as practicable but not later than 365 days after the date on
which the petition was filed.’’
Pub. L. 101–239, § 6601(e)(1), redesignated subsec. (d) as
(e). Former subsec. (e) redesignated (f).
Subsec. (f). Pub. L. 101–239, § 6601(i), inserted ‘‘within
60 days of the date of entry of the United States Claims
Court’s judgment with such court of appeals’’ after
‘‘with such court of appeals’’.
Pub. L. 101–239, § 6601(e)(1), redesignated subsec. (e) as
(f).
1988—Subsec. (c)(2). Pub. L. 100–360, § 411(o)(3)(A),
added Pub. L. 100–203, § 4308(a), see 1987 Amendment
note below.
Subsec. (e). Pub. L. 100–360, § 411(o)(2), made technical
amendment to directory language of Pub. L. 100–203,
§ 4307(3)(C), see 1987 Amendment note below.
Pub. L. 100–360, § 411(o)(3)(A), added Pub. L. 100–203,
§ 4308(b), see 1987 Amendment note below.
1987—Subsec. (a). Pub. L. 100–203, § 4307(3)(A), substituted ‘‘United States Claims Court’’ for ‘‘district
courts of the United States’’ and ‘‘the court’’ for ‘‘the
courts’’.
Subsec. (c)(1). Pub. L. 100–203, § 4307(3)(B), substituted
‘‘the United States Claims Court’’ for ‘‘the district
court of the United States in which the petition is
filed’’.

§ 300aa–12

Subsec. (c)(2). Pub. L. 100–203, § 4308(a), as added by
Pub. L. 100–360, § 411(o)(3)(A), inserted ‘‘, shall prepare
and submit to the court proposed findings of fact and
conclusions of law,’’ in introductory provisions and
struck out subpar. (E) which read as follows: ‘‘prepare
and submit to the court proposed findings of fact and
conclusions of law.’’
Subsec. (e). Pub. L. 100–203, § 4308(b), as added by Pub.
L. 100–360, § 411(o)(3)(A), inserted ‘‘within 60 days of the
date of the judgment’’ after ‘‘petition filed’’.
Pub. L. 100–203, § 4307(3)(C), as amended by Pub. L.
100–360, § 411(o)(2), substituted ‘‘the United States
Claims Court’’ for ‘‘a district court of the United
States’’ and ‘‘for the Federal Circuit’’ for ‘‘for the circuit in which the court is located’’.
Pub. L. 100–203, § 4303(d)(2)(A), redesignated subsec. (g)
as (e) and struck out former subsec. (e) relating to administration of an award.
Subsec. (f). Pub. L. 100–203, § 4303(d)(2)(A), struck out
subsec. (f) which related to revision of an award.
Subsec. (g). Pub. L. 100–203, § 4303(d)(2)(A), redesignated subsec. (g) as (e).
CHANGE OF NAME
‘‘United States magistrate judges’’ substituted for
‘‘United States magistrates’’ in subsec. (c)(6)(C) pursuant to section 321 of Pub. L. 101–650, set out as a note
under section 631 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by section 201(d)(1) of Pub. L. 102–168 effective as if in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102–168, set out as a note under
section 300aa–11 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–502 effective Sept. 30, 1990,
see section 5(h) of Pub. L. 101–502, set out as a note
under section 300aa–11 of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, except that
such suspension be excluded in determining the 240-day
period prescribed in subsec. (d) of this section, see section 6601(s)(1) of Pub. L. 101–239, set out as a note under
section 300aa–10 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Except as specifically provided in section 411 of Pub.
L. 100–360, amendment by Pub. L. 100–360, as it relates
to a provision in the Omnibus Budget Reconciliation
Act of 1987, Pub. L. 100–203, effective as if included in
the enactment of that provision in Pub. L. 100–203, see
section 411(a) of Pub. L. 100–360, set out as a Reference
to OBRA; Effective Date note under section 106 of Title
1, General Provisions.
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
in subsec. (c)(6)(E) of this section relating to reporting
annually to the Congress, see section 3003 of Pub. L.
104–66, as amended, set out as a note under section 1113
of Title 31, Money and Finance, and page 13 of House
Document No. 103–7.
REVIEW BY 3-JUDGE PANEL
Section 322(c) of Pub. L. 99–660, as added by Pub. L.
101–502, § 5(g)(2), Nov. 3, 1990, 104 Stat. 1288, and amended

§ 300aa–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

by Pub. L. 102–572, title IX, § 902(b)(1), Oct. 29, 1992, 106
Stat. 4516, provided that: ‘‘If the review authorized by
section 2112(f) [subsec. (f) of this section] is held invalid
because the judgment of the United States Court of
Federal Claims being reviewed did not arise from a case
or controversy under Article III of the Constitution,
such judgment shall be reviewed by a 3-judge panel of
the United States Court of Federal Claims. Such panel
shall not include the judge who participated in such
judgment.’’
[Enactment of section 322(c) of Pub. L. 99–660 by section 5(g)(2) of Pub. L. 101–502, set out above, effective
Nov. 14, 1986, see section 5(h) of Pub. L. 101–502, set out
as an Effective Date of 1990 Amendment note under section 300aa–11 of this title.]

§ 300aa–13. Determination of eligibility and compensation
(a) General rule
(1) Compensation shall be awarded under the
Program to a petitioner if the special master or
court finds on the record as a whole—
(A) that the petitioner has demonstrated by
a preponderance of the evidence the matters
required
in
the
petition
by
section
300aa–11(c)(1) of this title, and
(B) that there is not a preponderance of the
evidence that the illness, disability, injury,
condition, or death described in the petition is
due to factors unrelated to the administration
of the vaccine described in the petition.
The special master or court may not make such
a finding based on the claims of a petitioner
alone, unsubstantiated by medical records or by
medical opinion.
(2) For purposes of paragraph (1), the term
‘‘factors unrelated to the administration of the
vaccine’’—
(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and
(B) may, as documented by the petitioner’s
evidence or other material in the record, include infection, toxins, trauma (including
birth trauma and related anoxia), or metabolic
disturbances which have no known relation to
the vaccine involved, but which in the particular case are shown to have been the agent or
agents principally responsible for causing the
petitioner’s illness, disability, injury, condition, or death.
(b) Matters to be considered
(1) In determining whether to award compensation to a petitioner under the Program,
the special master or court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
(A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is
contained in the record regarding the nature,
causation, and aggravation of the petitioner’s
illness, disability, injury, condition, or death,
and
(B) the results of any diagnostic or evaluative test which are contained in the record and
the summaries and conclusions.
Any such diagnosis, conclusion, judgment, test
result, report, or summary shall not be binding
on the special master or court. In evaluating the

Page 1150

weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the special master or court shall consider
the entire record and the course of the injury,
disability, illness, or condition until the date of
the judgment of the special master or court.
(2) The special master or court may find the
first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition
occurred within the time period described in the
Vaccine Injury Table even though the occurrence of such symptom or manifestation was not
recorded or was incorrectly recorded as having
occurred outside such period. Such a finding
may be made only upon demonstration by a preponderance of the evidence that the onset or significant aggravation of the injury, disability,
illness, condition, or death described in the petition did in fact occur within the time period described in the Vaccine Injury Table.
(c) ‘‘Record’’ defined
For purposes of this section, the term
‘‘record’’ means the record established by the
special masters of the United States Court of
Federal Claims in a proceeding on a petition
filed under section 300aa–11 of this title.
(July 1, 1944, ch. 373, title XXI, § 2113, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3763; amended Pub. L. 100–203, title IV,
§ 4307(4), Dec. 22, 1987, 101 Stat. 1330–224; Pub. L.
101–239, title VI, § 6601(j), Dec. 19, 1989, 103 Stat.
2290; Pub. L. 101–502, § 5(c), Nov. 3, 1990, 104 Stat.
1287; Pub. L. 102–572, title IX, § 902(b)(1), Oct. 29,
1992, 106 Stat. 4516.)
PRIOR PROVISIONS
A prior section 300aa–13, act July 1, 1944, § 2114, was
successively renumbered by subsequent acts and transferred, see section 238k of this title.
A prior section 2113 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238j of this title.
AMENDMENTS
1992—Subsec. (c). Pub. L. 102–572 substituted ‘‘United
States Court of Federal Claims’’ for ‘‘United States
Claims Court’’.
1990—Subsec. (c). Pub. L. 101–502 inserted ‘‘the’’ after
‘‘special masters of’’.
1989—Subsecs. (a)(1), (b). Pub. L. 101–239, § 6601(j)(1),
substituted ‘‘special master or court’’ for ‘‘court’’
wherever appearing.
Subsec. (c). Pub. L. 101–239, § 6601(j)(2), inserted ‘‘special masters of’’ after ‘‘established by the’’.
1987—Subsec. (c). Pub. L. 100–203 substituted ‘‘the
United States Claims Court’’ for ‘‘a district court of
the United States’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–502 effective Sept. 30, 1990,
see section 5(h) of Pub. L. 101–502, set out as a note
under section 300aa–11 of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently

Page 1151

VACCINE INJURY TABLE—Continued

pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–14. Vaccine Injury Table
(a) Initial table
The following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and
deaths resulting from the administration of
such vaccines, and the time period in which the
first symptom or manifestation of onset or of
the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to
occur after vaccine administration for purposes
of receiving compensation under the Program:
VACCINE INJURY TABLE
I.

II.

DTP; P; DTP/Polio Combination;
or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell
Bacteria, or Specific Pertussis
Antigen(s).
Illness, disability, injury, or condition covered:

A. Anaphylaxis or anaphylactic
shock .......................................
B. Encephalopathy (or encephalitis) .........................................
C. Shock-collapse or hypotonichyporesponsive collapse ..........
D. Residual seizure disorder in
accordance with subsection
(b)(2) ........................................
E. Any acute complication or sequela (including death) of an
illness, disability, injury, or
condition referred to above
which illness, disability, injury, or condition arose within
the time period prescribed .......
Measles, mumps, rubella, or any
vaccine containing any of the
foregoing as a component; DT;
Td; or Tetanus Toxoid.
A. Anaphylaxis or anaphylactic
shock .......................................
B. Encephalopathy (or encephalitis) .........................................

C. Residual seizure disorder in
accordance with subsection
(b)(2) ........................................

III.

§ 300aa–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

D. Any acute complication or sequela (including death) of an
illness, disability, injury, or
condition referred to above
which illness, disability, injury, or condition arose within
the time period prescribed .......
Polio Vaccines (other than Inactivated Polio Vaccine).
A. Paralytic polio
—in a non-immunodeficient recipient ..................................

Time period for first
symptom or manifestation of onset or
of significant aggravation after vaccine
administration:
24 hours
3 days
3 days

3 days

Not applicable

24 hours
15 days (for mumps, rubella, measles, or
any vaccine containing any of the foregoing as a component). 3 days (for DT,
Td, or tetanus toxoid).

15 days (for mumps, rubella, measles, or
any vaccine containing any of the foregoing as a component). 3 days (for DT,
Td, or tetanus toxoid).

Not applicable

30 days

IV.

—in an immunodeficient recipient .......................................
—in a vaccine-associated community case ..........................
B. Any acute complication or sequela (including death) of an
illness, disability, injury, or
condition referred to above
which illness, disability, injury, or condition arose within
the time period prescribed .......
Inactivated Polio Vaccine.
A. Anaphylaxis or anaphylactic
shock .......................................
B. Any acute complication or sequela (including death) of an
illness, disability, injury, or
condition referred to above
which illness, disability, injury, or condition arose within
the time period prescribed .......

6 months
Not applicable

Not applicable

24 hours

Not applicable

(b) Qualifications and aids to interpretation
The following qualifications and aids to interpretation shall apply to the Vaccine Injury
Table in subsection (a) of this section:
(1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of
muscle tone, paralysis (partial or complete),
hemiplegia or hemiparesis, loss of color or
turning pale white or blue, unresponsiveness
to environmental stimuli, depression of consciousness, loss of consciousness, prolonged
sleeping with difficulty arousing, or cardiovascular or respiratory arrest.
(2) A petitioner may be considered to have
suffered a residual seizure disorder if the petitioner did not suffer a seizure or convulsion
unaccompanied by fever or accompanied by a
fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the
administration of the vaccine involved and if—
(A) in the case of a measles, mumps, or rubella vaccine or any combination of such
vaccines, the first seizure or convulsion occurred within 15 days after administration of
the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a
fever of less than 102 degrees Fahrenheit,
and
(B) in the case of any other vaccine, the
first seizure or convulsion occurred within 3
days after administration of the vaccine and
2 or more seizures or convulsions occurred
within 1 year after the administration of the
vaccine which were unaccompanied by fever
or accompanied by a fever of less than 102
degrees Fahrenheit.
(3)(A) The term ‘‘encephalopathy’’ means
any significant acquired abnormality of, or injury to, or impairment of function of the
brain. Among the frequent manifestations of
encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or
changes lasting at least 6 hours in level of consciousness, with or without convulsions. The
neurological signs and symptoms of encephalopathy may be temporary with complete recovery, or may result in various degrees of
permanent impairment. Signs and symptoms
such as high pitched and unusual screaming,

§ 300aa–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

persistent unconsolable crying, and bulging
fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow
wave activity on an electroencephalogram.
(B) If in a proceeding on a petition it is
shown by a preponderance of the evidence that
an encephalopathy was caused by infection,
toxins, trauma, or metabolic disturbances the
encephalopathy shall not be considered to be a
condition set forth in the table. If at the time
a judgment is entered on a petition filed under
section 300aa–11 of this title for a vaccine-related injury or death it is not possible to determine the cause, by a preponderance of the
evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition
set forth in the table. In determining whether
or not an encephalopathy is a condition set
forth in the table, the court shall consider the
entire medical record.
(4) For purposes of paragraphs (2) and (3), the
terms ‘‘seizure’’ and ‘‘convulsion’’ include
grand mal, petit mal, absence, myoclonic,
tonic-clonic, and focal motor seizures and
signs. If a provision of the table to which paragraph (1), (2), (3), or (4) applies is revised under
subsection (c) or (d) of this section, such paragraph shall not apply to such provision after
the effective date of the revision unless the revision specifies that such paragraph is to continue to apply.
(c) Administrative revision of table
(1) The Secretary may promulgate regulations
to modify in accordance with paragraph (3) the
Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice
and opportunity for a public hearing and at least
180 days of public comment.
(2) Any person (including the Advisory Commission on Childhood Vaccines) may petition
the Secretary to propose regulations to amend
the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such
petition shall be referred to the Commission for
its recommendations. Following—
(A) receipt of any recommendation of the
Commission, or
(B) 180 days after the date of the referral to
the Commission,
whichever occurs first, the Secretary shall conduct a rulemaking proceeding on the matters
proposed in the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding.
(3) A modification of the Vaccine Injury Table
under paragraph (1) may add to, or delete from,
the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may
be provided or may change the time periods for
the first symptom or manifestation of the onset
or the significant aggravation of any such injury, disability, illness, condition, or death.
(4) Any modification under paragraph (1) of
the Vaccine Injury Table shall apply only with
respect to petitions for compensation under the
Program which are filed after the effective date
of such regulation.

Page 1152

(d) Role of Commission
Except with respect to a regulation recommended by the Advisory Commission on
Childhood Vaccines, the Secretary may not propose a regulation under subsection (c) of this
section or any revision thereof, unless the Secretary has first provided to the Commission a
copy of the proposed regulation or revision, requested recommendations and comments by the
Commission, and afforded the Commission at
least 90 days to make such recommendations.
(e) Additional vaccines
(1) Vaccines recommended before August 1,
1993
By August 1, 1995, the Secretary shall revise
the Vaccine Injury Table included in subsection (a) of this section to include—
(A) vaccines which are recommended to
the Secretary by the Centers for Disease
Control and Prevention before August 1,
1993, for routine administration to children,
(B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
(C) the time period in which the first
symptoms or manifestations of onset or
other significant aggravation of such injuries, disabilities, illnesses, conditions, and
deaths associated with such vaccines may
occur.
(2) Vaccines recommended after August 1, 1993
When after August 1, 1993, the Centers for
Disease Control and Prevention recommends a
vaccine to the Secretary for routine administration to children, the Secretary shall, within 2 years of such recommendation, amend the
Vaccine Injury Table included in subsection
(a) of this section to include—
(A) vaccines which were recommended for
routine administration to children,
(B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
(C) the time period in which the first
symptoms or manifestations of onset or
other significant aggravation of such injuries, disabilities, illnesses, conditions, and
deaths associated with such vaccines may
occur.
(July 1, 1944, ch. 373, title XXI, § 2114, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3764; amended Pub. L. 101–239, title VI,
§ 6601(k), Dec. 19, 1989, 103 Stat. 2290; Pub. L.
103–66, title XIII, § 13632(a)(2), Aug. 10, 1993, 107
Stat. 645.)
PRIOR PROVISIONS
A prior section 300aa–14, act July 1, 1944, § 2115, was
successively renumbered by subsequent acts and transferred, see section 238l of this title.
A prior section 2114 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238k of this title.
AMENDMENTS
1993—Subsec. (e). Pub. L. 103–66 amended heading and
text of subsec. (e) generally. Prior to amendment, text
read as follows: ‘‘The Secretary may recommend to
Congress revisions of the table to change the vaccines
covered by the table.’’

Page 1153

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1989—Subsec. (a). Pub. L. 101–239, § 6601(k)(1), substituted ‘‘(b)(2)’’ for ‘‘(c)(2)’’ in items I.D. and II.C. in
table.
Subsec. (b)(3)(B). Pub. L. 101–239, § 6601(k)(2), substituted ‘‘300aa–11 of this title’’ for ‘‘300aa–11(b) of this
title’’.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.
REVISIONS OF VACCINE INJURY TABLE
The Vaccine Injury Table as modified by regulations
promulgated by the Secretary of Health and Human
Services is set out at 42 CFR 100.3.
Section 13632(a)(3) of Pub. L. 103–66 provided that: ‘‘A
revision by the Secretary under section 2114(e) of the
Public Health Service Act (42 U.S.C. 300aa–14(e)) (as
amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to provide funds for compensation paid with respect to the vaccine to be added
to the vaccine injury table in section 2114(a) of the Public Health Service Act (42 U.S.C. 300aa–14(a)).’’

§ 300aa–15. Compensation
(a) General rule
Compensation awarded under the Program to
a petitioner under section 300aa–11 of this title
for a vaccine-related injury or death associated
with the administration of a vaccine after October 1, 1988, shall include the following:
(1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and reasonable projected unreimbursable expenses which—
(i) result from the vaccine-related injury
for which the petitioner seeks compensation,
(ii) have been or will be incurred by or on
behalf of the person who suffered such injury, and
(iii)(I) have been or will be for diagnosis
and medical or other remedial care determined to be reasonably necessary, or
(II) have been or will be for rehabilitation,
developmental evaluation, special education, vocational training and placement,
case management services, counseling, emotional or behavioral therapy, residential and
custodial care and service expenses, special
equipment, related travel expenses, and facilities determined to be reasonably necessary.
(B) Subject to section 300aa–16(a)(2) of this
title, actual unreimbursable expenses incurred
before the date of the judgment awarding such
expenses which—
(i) resulted from the vaccine-related injury
for which the petitioner seeks compensation,
(ii) were incurred by or on behalf of the
person who suffered such injury, and
(iii) were for diagnosis, medical or other
remedial care, rehabilitation, developmental
evaluation, special education, vocational
training and placement, case management
services, counseling, emotional or behavioral therapy, residential and custodial care
and service expenses, special equipment, re-

§ 300aa–15

lated travel expenses, and facilities determined to be reasonably necessary.
(2) In the event of a vaccine-related death,
an award of $250,000 for the estate of the deceased.
(3)(A) In the case of any person who has sustained a vaccine-related injury after attaining
the age of 18 and whose earning capacity is or
has been impaired by reason of such person’s
vaccine-related injury for which compensation
is to be awarded, compensation for actual and
anticipated loss of earnings determined in accordance with generally recognized actuarial
principles and projections.
(B) In the case of any person who has sustained a vaccine-related injury before attaining the age of 18 and whose earning capacity is
or has been impaired by reason of such person’s vaccine-related injury for which compensation is to be awarded and whose vaccinerelated injury is of sufficient severity to permit reasonable anticipation that such person
is likely to suffer impaired earning capacity at
age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly
earnings of workers in the private, non-farm
sector, less appropriate taxes and the average
cost of a health insurance policy, as determined by the Secretary.
(4) For actual and projected pain and suffering and emotional distress from the vaccinerelated injury, an award not to exceed $250,000.
(b) Vaccines administered before effective date
Compensation awarded under the Program to
a petitioner under section 300aa–11 of this title
for a vaccine-related injury or death associated
with the administration of a vaccine before October 1, 1988, may include the compensation described in paragraphs (1)(A) and (2) of subsection
(a) of this section and may also include an
amount, not to exceed a combined total of
$30,000, for—
(1) lost earnings (as provided in paragraph
(3) of subsection (a) of this section),
(2) pain and suffering (as provided in paragraph (4) of subsection (a) of this section), and
(3) reasonable attorneys’ fees and costs (as
provided in subsection (e) of this section.1
(c) Residential and custodial care and service
The amount of any compensation for residential and custodial care and service expenses
under subsection (a)(1) of this section shall be
sufficient to enable the compensated person to
remain living at home.
(d) Types of compensation prohibited
Compensation awarded under the Program
may not include the following:
(1) Punitive or exemplary damages.
(2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a) of this section, compensation for
other than the health, education, or welfare of
the person who suffered the vaccine-related injury with respect to which the compensation
is paid.
1 So in original. Probably should be preceded by a closing
parenthesis.

§ 300aa–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Attorneys’ fees
(1) In awarding compensation on a petition
filed under section 300aa–11 of this title the special master or court shall also award as part of
such compensation an amount to cover—
(A) reasonable attorneys’ fees, and
(B) other costs,
incurred in any proceeding on such petition. If
the judgment of the United States Court of Federal Claims on such a petition does not award
compensation, the special master or court may
award an amount of compensation to cover petitioner’s reasonable attorneys’ fees and other
costs incurred in any proceeding on such petition if the special master or court determines
that the petition was brought in good faith and
there was a reasonable basis for the claim for
which the petition was brought.
(2) If the petitioner, before October 1, 1988,
filed a civil action for damages for any vaccinerelated injury or death for which compensation
may be awarded under the Program, and petitioned under section 300aa–11(a)(5) of this title
to have such action dismissed and to file a petition for compensation under the Program, in
awarding compensation on such petition the
special master or court may include an amount
of compensation limited to the costs and expenses incurred by the petitioner and the attorney of the petitioner before October 1, 1988, in
preparing, filing, and prosecuting such civil action (including the reasonable value of the attorney’s time if the civil action was filed under
contingent fee arrangements).
(3) No attorney may charge any fee for services in connection with a petition filed under
section 300aa–11 of this title which is in addition
to any amount awarded as compensation by the
special master or court under paragraph (1).
(f) Payment of compensation
(1) Except as provided in paragraph (2), no
compensation may be paid until an election has
been made, or has been deemed to have been
made, under section 300aa–21(a) of this title to
receive compensation.
(2) Compensation described in subsection
(a)(1)(A)(iii) of this section shall be paid from
the date of the judgment of the United States
Court of Federal Claims under section 300aa–12
of this title awarding the compensation. Such
compensation may not be paid after an election
under section 300aa–21(a) of this title to file a
civil action for damages for the vaccine-related
injury or death for which such compensation
was awarded.
(3) Payments of compensation under the Program and the costs of carrying out the Program
shall be exempt from reduction under any order
issued under part C of the Balanced Budget and
Emergency Deficit Control Act of 1985 [2 U.S.C.
900 et seq.].
(4)(A) Except as provided in subparagraph (B),
payment of compensation under the Program
shall be determined on the basis of the net
present value of the elements of the compensation and shall be paid from the Vaccine Injury
Compensation Trust Fund established under section 9510 of title 26 in a lump sum of which all
or a portion may be used as ordered by the special master to purchase an annuity or otherwise

Page 1154

be used, with the consent of the petitioner, in a
manner determined by the special master to be
in the best interests of the petitioner.
(B) In the case of a payment of compensation
under the Program to a petitioner for a vaccinerelated injury or death associated with the administration of a vaccine before October 1, 1988,
the compensation shall be determined on the
basis of the net present value of the elements of
compensation and shall be paid from appropriations made available under subsection (j) of this
section in a lump sum of which all or a portion
may be used as ordered by the special master to
purchase an annuity or otherwise be used, with
the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner. Any reasonable attorneys’ fees and costs shall be paid in a lump sum.
If the appropriations under subsection (j) of this
section are insufficient to make a payment of an
annual installment, the limitation on civil actions prescribed by section 300aa–21(a) of this
title shall not apply to a civil action for damages brought by the petitioner entitled to the
payment.
(C) In purchasing an annuity under subparagraph (A) or (B), the Secretary may purchase a
guarantee for the annuity, may enter into agreements regarding the purchase price for and rate
of return of the annuity, and may take such
other actions as may be necessary to safeguard
the financial interests of the United States regarding the annuity. Any payment received by
the Secretary pursuant to the preceding sentence shall be paid to the Vaccine Injury Compensation Trust Fund established under section
9510 of title 26, or to the appropriations account
from which the funds were derived to purchase
the annuity, whichever is appropriate.
(g) Program not primarily liable
Payment of compensation under the Program
shall not be made for any item or service to the
extent that payment has been made, or can reasonably be expected to be made, with respect to
such item or service (1) under any State compensation program, under an insurance policy,
or under any Federal or State health benefits
program (other than under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]), or (2)
by an entity which provides health services on a
prepaid basis.
(h) Liability of health insurance carriers, prepaid health plans, and benefit providers
No policy of health insurance may make payment of benefits under the policy secondary to
the payment of compensation under the Program and—
(1) no State, and
(2) no entity which provides health services
on a prepaid basis or provides health benefits,
may make the provision of health services or
health benefits secondary to the payment of
compensation under the Program, except that
this subsection shall not apply to the provision
of services or benefits under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.].
(i) Source of compensation
(1) Payment of compensation under the Program to a petitioner for a vaccine-related injury

Page 1155

TITLE 42—THE PUBLIC HEALTH AND WELFARE

or death associated with the administration of a
vaccine before October 1, 1988, shall be made by
the Secretary from appropriations under subsection (j) of this section.
(2) Payment of compensation under the Program to a petitioner for a vaccine-related injury
or death associated with the administration of a
vaccine on or after October 1, 1988, shall be made
from the Vaccine Injury Compensation Trust
Fund established under section 9510 of title 26.
(j) Authorization
For the payment of compensation under the
Program to a petitioner for a vaccine-related injury or death associated with the administration of a vaccine before October 1, 1988, there are
authorized to be appropriated to the Department of Health and Human Services $80,000,000
for fiscal year 1989, $80,000,000 for fiscal year
1990, $80,000,000 for fiscal year 1991, $80,000,000 for
fiscal year 1992, $110,000,000 for fiscal year 1993,
and $110,000,000 for each succeeding fiscal year in
which a payment of compensation is required
under subsection (f)(4)(B) of this section.
Amounts appropriated under this subsection
shall remain available until expended.
(July 1, 1944, ch. 373, title XXI, § 2115, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3767; amended Pub. L. 100–203, title IV,
§§ 4302(b), 4303(a)–(d)(1), (e), (g), 4307(5), (6), Dec.
22, 1987, 101 Stat. 1330–221 to 1330–223, 1330–225;
Pub. L. 100–360, title IV, § 411(o)(1), July 1, 1988,
102 Stat. 808; Pub. L. 101–239, title VI, § 6601(c)(8),
(l), Dec. 19, 1989, 103 Stat. 2286, 2290; Pub. L.
101–502, § 5(d), Nov. 3, 1990, 104 Stat. 1287; Pub. L.
102–168, title II, § 201(e), (f), Nov. 26, 1991, 105
Stat. 1103; Pub. L. 102–531, title III, § 314, Oct. 27,
1992, 106 Stat. 3508; Pub. L. 102–572, title IX,
§ 902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L.
103–66, title XIII, § 13632(b), Aug. 10, 1993, 107
Stat. 646.)
REFERENCES IN TEXT
The Balanced Budget and Emergency Deficit Control
Act of 1985, referred to in subsec. (f)(3), is title II of
Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038. Part C of the
Act is classified generally to subchapter I (§ 900 et seq.)
of chapter 20 of Title 2, The Congress. For complete
classification of this Act to the Code, see Short Title
note set out under section 900 of Title 2 and Tables.
The Social Security Act, referred to in subsecs. (g)
and (h), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Title XIX of the Social Security Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For complete classification of this
Act to the Code, see section 1305 of this title and
Tables.
CODIFICATION
In subsecs. (a), (b), (e)(2), (f)(4)(B), (i), and (j), ‘‘October 1, 1988’’ substituted for ‘‘the effective date of this
subpart’’ on authority of section 323 of Pub. L. 99–660,
as amended, set out as an Effective Date note under
section 300aa–1 of this title.
PRIOR PROVISIONS
A prior section 300aa–15, act July 1, 1944, § 2116, was
successively renumbered by subsequent acts and transferred, see section 238m of this title.
A prior section 2115 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238l of this title.

§ 300aa–15

AMENDMENTS
1993—Subsec.
(j).
Pub.
L.
103–66
substituted
‘‘$110,000,000 for each succeeding fiscal year’’ for
‘‘$80,000,000 for each succeeding fiscal year’’.
1992—Subsecs. (e)(1), (f)(2). Pub. L. 102–572 substituted
‘‘United States Court of Federal Claims’’ for ‘‘United
States Claims Court’’.
Subsec. (j). Pub. L. 102–531 increased authorization for
fiscal year 1993 from $80,000,000 to $110,000,000.
1991—Subsec. (f)(4)(A). Pub. L. 102–168, § 201(e)(1)(A),
(2), struck out ‘‘of the proceeds’’ after ‘‘portion’’ and
substituted ‘‘Vaccine Injury Compensation Trust Fund
established under section 9510 of title 26’’ for ‘‘trust
fund’’.
Subsec. (f)(4)(B). Pub. L. 102–168, § 201(e)(1)(B), which
directed substitution of ‘‘shall be paid from appropriations made available under subsection (j) of this section in a lump sum of which all or a portion’’ for ‘‘paid
in 4 equal installments of which all or portion of the
proceeds’’ was executed by making the substitution for
‘‘paid in 4 equal annual installments of which all or a
portion of the proceeds’’ to reflect the probable intent
of Congress.
Subsec. (f)(4)(C). Pub. L. 102–168, § 201(f), added subpar.
(C).
1990—Subsec. (e)(2). Pub. L. 101–502, § 5(d)(1), inserted
‘‘of compensation’’ before ‘‘limited to the costs’’.
Subsec. (f)(2). Pub. L. 101–502, § 5(d)(2)(A), substituted
‘‘section 300aa–21(a)’’ for ‘‘section 300aa–21(b)’’.
Subsec. (f)(4)(B). Pub. L. 101–502, § 5(d)(2)(B), substituted ‘‘subsection (j)’’ for ‘‘subsection (i)’’ and ‘‘the
limitation on civil actions prescribed by section
300aa–21(a) of this title’’ for ‘‘section 300aa–11(a) of this
title’’.
Subsec. (j). Pub. L. 101–502, § 5(d)(3), inserted before
period at end of first sentence ‘‘, and $80,000,000 for
each succeeding fiscal year in which a payment of compensation is required under subsection (f)(4)(B) of this
section’’.
1989—Subsec. (b). Pub. L. 101–239, § 6601(l)(1), substituted ‘‘may include the compensation described in
paragraphs (1)(A) and (2) of subsection (a) of this section and may also include an amount, not to exceed a
combined total of $30,000, for—’’ and cls. (1) to (3) for
‘‘may not include the compensation described in paragraph (1)(B) of subsection (a) of this section and may
include attorneys’ fees and other costs included in a
judgment under subsection (e) of this section, except
that the total amount that may be paid as compensation under paragraphs (3) and (4) of subsection (a) of
this section and included as attorneys’ fees and other
costs under subsection (e) of this section may not exceed $30,000.’’
Subsec. (e)(1). Pub. L. 101–239, § 6601(l)(2)(A), substituted ‘‘In awarding compensation on a petition filed
under section 300aa–11 of this title the special master
or court shall also award as part of such compensation
an amount to cover’’ for ‘‘The judgment of the United
States Claims Court on a petition filed under section
300aa–11 of this title awarding compensation shall include an amount to cover’’.
Pub. L. 101–239, § 6601(l)(2)(B), (C), substituted ‘‘the
special master or court may award an amount of compensation to cover’’ for ‘‘the court may include in the
judgment an amount to cover’’ and ‘‘the special master
or court determines that the petition was brought in
good faith and there was a reasonable basis for the
claim for which the petition’’ for ‘‘the court determines
that the civil action was brought in good faith and
there was a reasonable basis for the claim for which the
civil action’’.
Subsec. (e)(2). Pub. L. 101–239, § 6601(l)(2)(D), which directed amendment of par. (2) by substituting ‘‘the special master or court may also award an amount of compensation’’ for ‘‘the judgment of the court on such petition may include an amount’’, could not be executed
because of the prior amendment by Pub. L. 101–239,
§ 6601(c)(8)(B), see Amendment note below.
Pub. L. 101–239, § 6601(c)(8), substituted ‘‘and petitioned under section 300aa–11(a)(5) of this title to have

§ 300aa–16

TITLE 42—THE PUBLIC HEALTH AND WELFARE

such action dismissed’’ for ‘‘and elected under section
300aa–11(a)(4) of this title to withdraw such action’’ and
‘‘in awarding compensation on such petition the special
master or court may include’’ for ‘‘the judgment of the
court on such petition may include’’.
Subsec. (e)(3). Pub. L. 101–239, § 6601(l)(2)(E), substituted ‘‘awarded as compensation by the special master or court under paragraph (1)’’ for ‘‘included under
paragraph (1) in a judgment on such petition’’.
Subsec. (f)(3). Pub. L. 101–239, § 6601(l)(3)(A), inserted
‘‘under the Program and the costs of carrying out the
Program’’ after ‘‘Payments of compensation’’.
Subsec. (f)(4)(A). Pub. L. 101–239, § 6601(l)(3)(B), struck
out ‘‘made in a lump sum’’ after ‘‘the Program shall
be’’ and inserted ‘‘and shall be paid from the trust fund
in a lump sum of which all or a portion of the proceeds
may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the
special master to be in the best interests of the petitioner’’ after ‘‘elements of the compensation’’.
Subsec. (f)(4)(B). Pub. L. 101–239, § 6601(l)(3)(C), substituted ‘‘determined on the basis of the net present
value of the elements of compensation and paid in 4
equal annual installments of which all or a portion of
the proceeds may be used as ordered by the special
master to purchase an annuity or otherwise be used,
with the consent of the petitioner, in a manner determined by the special master to be in the best interests
of the petitioner. Any reasonable attorneys’ fees and
costs shall be paid in a lump sum’’ for ‘‘paid in 4 equal
annual installments’’.
Subsec. (g). Pub. L. 101–239, § 6601(l)(4)(A), inserted
‘‘(other than under title XIX of the Social Security
Act)’’ after ‘‘State health benefits program’’.
Subsec. (h). Pub. L. 101–239, § 6601(l)(4)(B), inserted before period at end ‘‘, except that this subsection shall
not apply to the provision of services or benefits under
title XIX of the Social Security Act’’.
Subsec. (i)(1). Pub. L. 101–239, § 6601(l)(5), which directed amendment of par. (1) by substituting ‘‘(j)’’ for
‘‘(i)’’, could not be executed because ‘‘(i)’’ did not appear.
Subsec. (j). Pub. L. 101–239, § 6601(l)(6), struck out
‘‘and’’ after ‘‘fiscal year 1991,’’ and inserted
‘‘, $80,000,000 for fiscal year 1993’’ after ‘‘fiscal year
1992’’.
1988—Subsec. (i)(1). Pub. L. 100–360, § 411(o)(1)(A), substituted ‘‘by the Secretary from appropriations under
subsection (j)’’ for ‘‘from appropriations under subsection (i)’’.
Subsec. (j). Pub. L. 100–360, § 411(o)(1)(B), inserted ‘‘to
the Department of Health and Human Services’’.
1987—Subsec. (a). Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date of this subpart’’ for ‘‘effective
date of this part’’.
Pub. L. 100–203, § 4303(d)(1)(A), struck out last two sentences which read as follows: ‘‘Payments for projected
expenses shall be paid on a periodic basis (but no payment may be made for a period in excess of 1 year).
Payments for pain and suffering and emotional distress
and incurred expenses may be paid in a lump sum.’’
Subsec. (a)(1). Pub. L. 100–203, § 4303(c), struck out last
sentence of subpars. (A) and (B) each of which read as
follows: ‘‘The amount of unreimbursable expenses
which may be recovered under this subparagraph shall
be limited to the amount in excess of the amount set
forth in section 300aa–11(c)(1)(D)(ii) of this title.’’
Subsec. (b). Pub. L. 100–203, § 4303(e), substituted
‘‘may not include the compensation described in paragraph (1)(B) of subsection (a) of this section and may
include attorneys’ fees and other costs included in a
judgment under subsection (e) of this section, except
that the total amount that may be paid as compensation under paragraphs (3) and (4) of subsection (a) of
this section and included as attorneys’ fees and other
costs under subsection (e) of this section may not exceed $30,000’’ for ‘‘shall only include the compensation
described in paragraphs (1)(A) and (2) of subsection (a)
of this section’’.

Page 1156

Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date
of this subpart’’ for ‘‘effective date of this part’’.
Subsec. (e)(1). Pub. L. 100–203, § 4307(5), substituted ‘‘of
the United States Claims Court’’ for ‘‘of a court’’ in
two places.
Subsec. (e)(2). Pub. L. 100–203, § 4302(b), substituted
‘‘effective date of this subpart, filed a’’ for ‘‘effective
date of this subchapter, filed a’’ and ‘‘effective date of
this subpart in preparing’’ for ‘‘effective date of this
part in preparing’’.
Subsec. (f). Pub. L. 100–203, § 4303(d)(1)(B), (g), added
par. (4) and redesignated a second subsec. (f), relating
to the Program not being primarily liable, as subsec.
(g).
Subsec. (f)(2). Pub. L. 100–203, § 4307(6), substituted
‘‘United States Claims Court’’ for ‘‘district court of the
United States’’.
Subsecs. (g), (h). Pub. L. 100–203, § 4303(g), redesignated a second subsec. (f), relating to the Program not
being liable, as (g) and redesignated former subsec. (g)
as (h).
Subsecs. (i), (j). Pub. L. 100–203, § 4303(a), (b), added
subsecs. (i) and (j).
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by section 201(f) of Pub. L. 102–168 effective as if in effect on and after Oct. 1, 1988, see section
201(i)(2) of Pub. L. 102–168, set out as a note under section 300aa–11 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–502 effective Sept. 30, 1990,
see section 5(h) of Pub. L. 101–502, set out as a note
under section 300aa–11 of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
Amendment by Pub. L. 101–239 applicable to all pending and subsequently filed petitions, see section
6601(s)(2) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Except as specifically provided in section 411 of Pub.
L. 100–360, amendment by Pub. L. 100–360, as it relates
to a provision in the Omnibus Budget Reconciliation
Act of 1987, Pub. L. 100–203, effective as if included in
the enactment of that provision in Pub. L. 100–203, see
section 411(a) of Pub. L. 100–360, set out as a Reference
to OBRA; Effective Date note under section 106 of Title
1, General Provisions.

§ 300aa–16. Limitations of actions
(a) General rule
In the case of—
(1) a vaccine set forth in the Vaccine Injury
Table which is administered before October 1,
1988, if a vaccine-related injury or death occurred as a result of the administration of
such vaccine, no petition may be filed for compensation under the Program for such injury
or death after the expiration of 28 months
after October 1, 1988, and no such petition may
be filed if the first symptom or manifestation
of onset or of the significant aggravation of
such injury occurred more than 36 months
after the date of administration of the vaccine,
(2) a vaccine set forth in the Vaccine Injury
Table which is administered after October 1,

Page 1157

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1988, if a vaccine-related injury occurred as a
result of the administration of such vaccine,
no petition may be filed for compensation
under the Program for such injury after the
expiration of 36 months after the date of the
occurrence of the first symptom or manifestation of onset or of the significant aggravation
of such injury, and
(3) a vaccine set forth in the Vaccine Injury
Table which is administered after October 1,
1988, if a death occurred as a result of the administration of such vaccine, no petition may
be filed for compensation under the Program
for such death after the expiration of 24
months from the date of the death and no such
petition may be filed more than 48 months
after the date of the occurrence of the first
symptom or manifestation of onset or of the
significant aggravation of the injury from
which the death resulted.
(b) Effect of revised table
If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit
an individual who was not, before such revision,
eligible to seek compensation under the Program, or to significantly increase the likelihood
of obtaining compensation, such person may,
notwithstanding section 300aa–11(b)(2) of this
title, file a petition for such compensation not
later than 2 years after the effective date of the
revision, except that no compensation may be
provided under the Program with respect to a
vaccine-related injury or death covered under
the revision of the table if—
(1) the vaccine-related death occurred more
than 8 years before the date of the revision of
the table, or
(2) the vaccine-related injury occurred more
than 8 years before the date of the revision of
the table.
(c) State limitations of actions
If a petition is filed under section 300aa–11 of
this title for a vaccine-related injury or death,
limitations of actions under State law shall be
stayed with respect to a civil action brought for
such injury or death for the period beginning on
the date the petition is filed and ending on the
date (1) an election is made under section
300aa–21(a) of this title to file the civil action or
(2) an election is made under section 300aa–21(b)
of this title to withdraw the petition.
(July 1, 1944, ch. 373, title XXI, § 2116, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3769; amended Pub. L. 100–203, title IV,
§ 4302(b)(2), Dec. 22, 1987, 101 Stat. 1330–221; Pub.
L. 101–239, title VI, § 6601(m)(1), Dec. 19, 1989, 103
Stat. 2291; Pub. L. 101–502, § 5(e), Nov. 3, 1990, 104
Stat. 1287; Pub. L. 102–168, title II, § 201(d)(2),
Nov. 26, 1991, 105 Stat. 1103; Pub. L. 103–66, title
XIII, § 13632(a)(1), Aug. 10, 1993, 107 Stat. 645.)
CODIFICATION
In subsec. (a)(1) to (3), ‘‘October 1, 1988’’ and ‘‘October
1, 1988,’’ substituted for ‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as
amended, set out as an Effective Date note under section 300aa–1 of this title.
PRIOR PROVISIONS
A prior section 2116 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238m of this title.

§ 300aa–17

AMENDMENTS
1993—Subsec. (b). Pub. L. 103–66 substituted ‘‘or to
significantly increase the likelihood of obtaining compensation, such person may, notwithstanding section
300aa–11(b)(2) of this title, file’’ for ‘‘such person may
file’’.
1991—Subsec. (c). Pub. L. 102–168 substituted ‘‘or (2)’’
for ‘‘, (2)’’ and struck out ‘‘, or (3) the petition is considered withdrawn under section 300aa–21(b) of this
title.’’
1990—Subsec. (a)(1). Pub. L. 101–502, § 5(e)(1), substituted ‘‘28 months’’ for ‘‘24 months’’ and inserted before comma at end ‘‘and no such petition may be filed
if the first symptom or manifestation of onset or of the
significant aggravation of such injury occurred more
than 36 months after the date of administration of the
vaccine’’.
Subsec. (c). Pub. L. 101–502, § 5(e)(2), substituted ‘‘and
ending on the date (1) an election is made under section
300aa–21(a) of this title to file the civil action, (2) an
election is made under section 300aa–21(b) of this title
to withdraw the petition, or (3) the petition is considered withdrawn under section 300aa–21(b) of this title’’
for ‘‘and ending on the date a final judgment is entered
on the petition’’.
1989—Subsec. (c). Pub. L. 101–239 substituted ‘‘300aa–11
of this title’’ for ‘‘300aa–11(b) of this title’’.
1987—Subsec. (a). Pub. L. 100–203 substituted ‘‘effective date of this subpart’’ for ‘‘effective date of this
subchapter’’ in pars. (1) to (3).
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102–168 effective as if in effect
on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L.
102–168, set out as a note under section 300aa–11 of this
title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101–502 effective Sept. 30, 1990,
see section 5(h) of Pub. L. 101–502, set out as a note
under section 300aa–11 of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–17. Subrogation
(a) General rule
Upon payment of compensation to any petitioner under the Program, the trust fund which
has been established to provide such compensation shall be subrograted 1 to all rights of the petitioner with respect to the vaccine-related injury or death for which compensation was paid,
except that the trust fund may not recover
under such rights an amount greater than the
amount of compensation paid to the petitioner.
(b) Disposition of amounts recovered
Amounts recovered under subsection (a) of
this section shall be collected on behalf of, and
deposited in, the Vaccine Injury Compensation
Trust Fund established under section 9510 of
title 26.
(July 1, 1944, ch. 373, title XXI, § 2117, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3770; amended Pub. L. 100–203, title IV,
1 So

in original. Probably should be ‘‘subrogated’’.

§ 300aa–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 4307(7), Dec. 22, 1987, 101 Stat. 1330–225; Pub. L.
101–239, title VI, § 6601(m)(2), Dec. 19, 1989, 103
Stat. 2291.)
AMENDMENTS
1989—Subsec. (b). Pub. L. 101–239 substituted ‘‘the
Vaccine Injury Compensation Trust Fund established
under section 9510 of title 26’’ for ‘‘the trust fund which
has been established to provide compensation under the
Program’’.
1987—Subsec. (a). Pub. L. 100–203 struck out par. (1)
designation before ‘‘Upon’’ and struck out par. (2)
which read as follows: ‘‘In any case in which it deems
such action appropriate, a district court of the United
States may, after entry of a final judgment providing
for compensation to be paid under section 300aa–15 of
this title for a vaccine-related injury or death, refer the
record of such proceeding to the Secretary and the Attorney General with such recommendation as the court
deems appropriate with respect to the investigation or
commencement of a civil action by the Secretary under
paragraph (1).’’
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–18. Repealed. Pub. L. 100–203, title IV,
§ 4303(d)(2)(B), Dec. 22, 1987, 101 Stat.
1330–222
Section, act July 1, 1944, ch. 373, title XXI, § 2118, as
added Nov. 14, 1986, Pub. L. 99–660, title III, § 311(a), 100
Stat. 3771, provided for annual increases for inflation of
compensation under subsections (a)(2) and (a)(4) of section 300aa–15 of this title and civil penalty under section 300aa–27(b) of this title.

§ 300aa–19. Advisory Commission on Childhood
Vaccines
(a) Establishment
There is established the Advisory Commission
on Childhood Vaccines. The Commission shall be
composed of:
(1) Nine members appointed by the Secretary as follows:
(A) Three members who are health professionals, who are not employees of the United
States, and who have expertise in the health
care of children, the epidemiology, etiology,
and prevention of childhood diseases, and
the adverse reactions associated with vaccines, of whom at least two shall be pediatricians.
(B) Three members from the general public, of whom at least two shall be legal representatives of children who have suffered a
vaccine-related injury or death.
(C) Three members who are attorneys, of
whom at least one shall be an attorney
whose specialty includes representation of
persons who have suffered a vaccine-related
injury or death and of whom one shall be an
attorney whose specialty includes representation of vaccine manufacturers.
(2) The Director of the National Institutes of
Health, the Assistant Secretary for Health,
the Director of the Centers for Disease Control

Page 1158

and Prevention, and the Commissioner of Food
and Drugs (or the designees of such officials),
each of whom shall be a nonvoting ex officio
member.
The Secretary shall select members of the Commission within 90 days of October 1, 1988. The
members of the Commission shall select a Chair
from among the members.
(b) Term of office
Appointed members of the Commission shall
be appointed for a term of office of 3 years, except that of the members first appointed, 3 shall
be appointed for a term of 1 year, 3 shall be appointed for a term of 2 years, and 3 shall be appointed for a term of 3 years, as determined by
the Secretary.
(c) Meetings
The Commission shall first meet within 60
days after all members of the Commission are
appointed, and thereafter shall meet not less
often than four times per year and at the call of
the chair. A quorum for purposes of a meeting is
5. A decision at a meeting is to be made by a
ballot of a majority of the voting members of
the Commission present at the meeting.
(d) Compensation
Members of the Commission who are officers
or employees of the Federal Government shall
serve as members of the Commission without
compensation in addition to that received in
their regular public employment. Members of
the Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for grade GS–18 of the
General Schedule for each day (including traveltime) they are engaged in the performance of
their duties as members of the Commission. All
members, while so serving away from their
homes or regular places of business, may be allowed travel expenses, including per diem in lieu
of subsistence, in the same manner as such expenses are authorized by section 5703 of title 5
for employees serving intermittently.
(e) Staff
The Secretary shall provide the Commission
with such professional and clerical staff, such
information, and the services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions
under this section.
(f) Functions
The Commission shall—
(1) advise the Secretary on the implementation of the Program,
(2) on its own initiative or as the result of
the filing of a petition, recommend changes in
the Vaccine Injury Table,
(3) advise the Secretary in implementing the
Secretary’s responsibilities under section
300aa–27 of this title regarding the need for
childhood vaccination products that result in
fewer or no significant adverse reactions,
(4) survey Federal, State, and local programs
and activities relating to the gathering of information on injuries associated with the administration of childhood vaccines, including

Page 1159

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300aa–21

the adverse reaction reporting requirements of
section 300aa–25(b) of this title, and advise the
Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines, and
(5) recommend to the Director of the National Vaccine Program research related to
vaccine injuries which should be conducted to
carry out this part.

clerk of the United States Court of Federal
Claims—
(1) if the judgment awarded compensation,
an election in writing to receive the compensation or to file a civil action for damages
for such injury or death, or
(2) if the judgment did not award compensation, an election in writing to accept the judgment or to file a civil action for damages for
such injury or death.

(July 1, 1944, ch. 373, title XXI, § 2119, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3771; amended Pub. L. 100–203, title IV,
§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221; Pub.
L. 102–168, title II, § 201(g), Nov. 26, 1991, 105 Stat.
1104; Pub. L. 102–531, title III, § 312(d)(14), Oct. 27,
1992, 106 Stat. 3505.)

An election shall be filed under this subsection
not later than 90 days after the date of the
court’s final judgment with respect to which the
election is to be made. If a person required to
file an election with the court under this subsection does not file the election within the
time prescribed for filing the election, such person shall be deemed to have filed an election to
accept the judgment of the court. If a person
elects to receive compensation under a judgment of the court in an action for a vaccine-related injury or death associated with the administration of a vaccine before October 1, 1988, or
is deemed to have accepted the judgment of the
court in such an action, such person may not
bring or maintain a civil action for damages
against a vaccine administrator or manufacturer for the vaccine-related injury or death for
which the judgment was entered. For limitations on the bringing of civil actions for vaccine-related injuries or deaths associated with
the administration of a vaccine after October 1,
1988, see section 300aa–11(a)(2) of this title.
(b) Continuance or withdrawal of petition
A petitioner under a petition filed under section 300aa–11 of this title may submit to the
United States Court of Federal Claims a notice
in writing choosing to continue or to withdraw
the petition if—
(1) a special master fails to make a decision
on such petition within the 240 days prescribed
by section 300aa–12(d)(3)(A)(ii) of this title (excluding (i) any period of suspension under section 300aa–12(d)(3)(C) or 300aa–12(d)(3)(D) of
this title, and (ii) any days the petition is before a special master as a result of a remand
under section 300aa–12(e)(2)(C) of this title), or
(2) the court fails to enter a judgment under
section 300aa–12 of this title on the petition
within 420 days (excluding (i) any period of
suspension under section 300aa–12(d)(3)(C) or
300aa–12(d)(3)(D) of this title, and (ii) any days
the petition is before a special master as a result of a remand under section 300aa–12(e)(2)(C)
of this title) after the date on which the petition was filed.

CODIFICATION
In subsec. (a), ‘‘October 1, 1988’’ substituted for ‘‘the
effective date of this subpart’’ on authority of section
323 of Pub. L. 99–660, as amended, set out as an Effective
Date note under section 300aa–1 of this title.
AMENDMENTS
1992—Subsec. (a)(2). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’.
1991—Subsec. (c). Pub. L. 102–168 inserted ‘‘present at
the meeting’’ before period at end.
1987—Subsec. (a). Pub. L. 100–203 substituted ‘‘effective date of this subpart’’ for ‘‘effective date of this
part’’ in last sentence.
TERMINATION OF ADVISORY COMMISSIONS
Advisory commissions established after Jan. 5, 1973,
to terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a commission established by the
President or an officer of the Federal Government, such
commission is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a commission established by the Congress, its duration
is otherwise provided by law. See sections 3(2) and 14 of
Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 776, set out in the
Appendix to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
SUBPART B—ADDITIONAL REMEDIES

§ 300aa–21. Authority to bring actions
(a) Election
After judgment has been entered by the United
States Court of Federal Claims or, if an appeal
is taken under section 300aa–12(f) of this title,
after the appellate court’s mandate is issued,
the petitioner who filed the petition under section 300aa–11 of this title shall file with the

Such a notice shall be filed within 30 days of the
provision of the notice required by section
300aa–12(g) of this title.
(c) Limitations of actions
A civil action for damages arising from a vaccine-related injury or death for which a petition
was filed under section 300aa–11 of this title
shall, except as provided in section 300aa–16(c) of
this title, be brought within the period prescribed by limitations of actions under State
law applicable to such civil action.
(July 1, 1944, ch. 373, title XXI, § 2121, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100

§ 300aa–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Stat. 3772; amended Pub. L. 100–203, title IV,
§§ 4304(c), 4307(8), 4308(c), Dec. 22, 1987, 101 Stat.
1330–224, 1330–225; Pub. L. 100–360, title IV,
§ 411(o)(3)(A), July 1, 1988, 102 Stat. 808; Pub. L.
101–239, title VI, § 6601(n), Dec. 19, 1989, 103 Stat.
2291; Pub. L. 101–502, § 5(f), Nov. 3, 1990, 104 Stat.
1287; Pub. L. 102–168, title II, § 201(d)(3), Nov. 26,
1991, 105 Stat. 1103; Pub. L. 102–572, title IX,
§ 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.)
CODIFICATION
In subsec. (a), ‘‘October 1, 1988,’’ and ‘‘October 1, 1988’’
substituted for ‘‘the effective date of this part’’.
AMENDMENTS
1992—Subsecs. (a), (b). Pub. L. 102–572 substituted
‘‘United States Court of Federal Claims’’ for ‘‘United
States Claims Court’’ wherever appearing.
1991—Subsec. (b). Pub. L. 102–168 substituted ‘‘Continuance or withdrawal of petition’’ for ‘‘Withdrawal of
petition’’ in heading, redesignated introductory provisions of par. (1) as introductory provisions of subsec. (b)
and substituted ‘‘a notice in writing choosing to continue or to withdraw the petition’’ for ‘‘a notice in
writing withdrawing the petition’’, redesignated subpars. (A) and (B) of former par. (1) as pars. (1) and (2),
respectively, and realigned margins, struck out at end
of former par. (1) ‘‘If such a notice is not filed before
the expiration of such 30 days, the petition with respect
to which the notice was to be filed shall be considered
withdrawn under this paragraph.’’, and struck out par.
(2) which read as follows: ‘‘If a special master or the
court does not enter a decision or make a judgment on
a petition filed under section 300aa–11 of this title within 30 days of the provision of the notice in accordance
with section 300aa–12(g) of this title, the special master
or court shall no longer have jurisdiction over such petition and such petition shall be considered as withdrawn under paragraph (1).’’
1990—Subsec. (a). Pub. L. 101–502, § 5(f)(1), in closing
provisions, inserted after second sentence ‘‘If a person
elects to receive compensation under a judgment of the
court in an action for a vaccine-related injury or death
associated with the administration of a vaccine before
October 1, 1988, or is deemed to have accepted the judgment of the court in such an action, such person may
not bring or maintain a civil action for damages
against a vaccine administrator or manufacturer for
the vaccine-related injury or death for which the judgment was entered.’’ and inserted ‘‘for vaccine-related
injuries or deaths associated with the administration of
a vaccine after October 1, 1988’’ after ‘‘actions’’ in last
sentence.
Subsec. (b). Pub. L. 101–502, § 5(f)(2), amended subsec.
(b) generally. Prior to amendment, subsec. (b) read as
follows: ‘‘If the United States Claims Court fails to
enter a judgment under section 300aa–12 of this title on
a petition filed under section 300aa–11 of this title within 420 days (excluding any period of suspension under
section 300aa–12(d) of this title and excluding any days
the petition is before a special master as a result of a
remand under section 300aa–12(e)(2)(C) of this title)
after the date on which the petition was filed, the petitioner may submit to the court a notice in writing
withdrawing the petition. An election shall be filed
under this subsection not later than 90 days after the
date of the entry of the Claims Court’s judgment or the
appellate court’s mandate with respect to which the
election is to be made. A person who has submitted a
notice under this subsection may, notwithstanding section 300aa–11(a)(2) of this title, thereafter maintain a
civil action for damages in a State or Federal court
without regard to this subpart and consistent with
otherwise applicable law.’’
1989—Subsec. (a). Pub. L. 101–239, § 6601(n)(1)(A),
amended introductory provisions generally. Prior to
amendment, introductory provisions read as follows:
‘‘After the judgment of the United States Claims Court

Page 1160

under section 300aa–11 of this title on a petition filed
for compensation under the Program for a vaccine-related injury or death has become final, the person who
filed the petition shall file with the court—’’.
Pub. L. 101–239, § 6601(n)(1)(B), amended last sentence
generally. Prior to amendment, last sentence read as
follows: ‘‘If a person elects to receive compensation
under a judgment of the court or is deemed to have accepted the judgment of the court, such person may not
bring or maintain a civil action for damages against a
vaccine manufacturer for the vaccine-related injury or
death for which the judgment was entered.’’
Subsec. (b). Pub. L. 101–239, § 6601(n)(2), substituted
‘‘within 420 days (excluding any period of suspension
under section 300aa–12(d) of this title and excluding any
days the petition is before a special master as a result
of a remand under section 300aa–12(e)(2)(C) of this
title)’’ for ‘‘within 365 days’’ in first sentence and
amended second sentence generally. Prior to amendment, second sentence read as follows: ‘‘Such a notice
shall be filed not later than 90 days after the expiration
of such 365-day period.’’
1988—Subsec. (a). Pub. L. 100–360 added Pub. L.
100–203, § 4308(c), see 1987 Amendment note below.
1987—Subsec. (a). Pub. L. 100–203, § 4308(c), as added by
Pub. L. 100–360, substituted ‘‘the court’s final judgment’’ for ‘‘the entry of the court’s judgment’’ in concluding provisions.
Pub. L. 100–203, § 4307(8), substituted ‘‘the United
States Claims Court’’ for ‘‘a district court of the
United States’’ and ‘‘the court’’ for ‘‘a court’’ in three
places.
Subsecs. (b), (c). Pub. L. 100–203, § 4304(c), added subsec. (b) and redesignated former subsec. (b) as (c).
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102–168 effective as in effect
on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L.
102–168, set out as a note under section 300aa–11 of this
title.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by section 5(f)(1) of Pub. L. 101–502 effective Nov. 14, 1986, and amendment by section 5(f)(2) of
Pub. L. 101–502 effective Sept. 30, 1990, see section 5(h)
of Pub. L. 101–502, set out as a note under section
300aa–11 of this title.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, except that
such suspension be excluded in determining the 420-day
period prescribed in subsec. (b) of this section, see section 6601(s)(1) of Pub. L. 101–239, set out as a note under
section 300aa–10 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Except as specifically provided in section 411 of Pub.
L. 100–360, amendment by Pub. L. 100–360, as it relates
to a provision in the Omnibus Budget Reconciliation
Act of 1987, Pub. L. 100–203, effective as if included in
the enactment of that provision in Pub. L. 100–203, see
section 411(a) of Pub. L. 100–360, set out as a Reference
to OBRA; Effective Date note under section 106 of Title
1, General Provisions.
EFFECTIVE DATE
Subpart effective Oct. 1, 1988, see section 323 of Pub.
L. 99–660, set out as a note under section 300aa–1 of this
title.

Page 1161

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300aa–22. Standards of responsibility
(a) General rule
Except as provided in subsections (b), (c), and
(e) of this section State law shall apply to a civil
action brought for damages for a vaccine-related
injury or death.
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in
a civil action for damages arising from a vaccine-related injury or death associated with the
administration of a vaccine after October 1, 1988,
if the injury or death resulted from side effects
that were unavoidable even though the vaccine
was properly prepared and was accompanied by
proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine
shall be presumed to be accompanied by proper
directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.] and section 262 of this title (including regulations issued under such provisions) applicable
to the vaccine and related to vaccine-related injury or death for which the civil action was
brought unless the plaintiff shows—
(A) that the manufacturer engaged in the
conduct set forth in subparagraph (A) or (B) of
section 300aa–23(d)(2) of this title, or
(B) by clear and convincing evidence that
the manufacturer failed to exercise due care
notwithstanding its compliance with such Act
and section (and regulations issued under such
provisions).
(c) Direct warnings
No vaccine manufacturer shall be liable in a
civil action for damages arising from a vaccinerelated injury or death associated with the administration of a vaccine after October 1, 1988,
solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the
injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d) Construction
The standards of responsibility prescribed by
this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages
were denied or which was dismissed with prejudice to bring a new civil action against such
manufacturer for such injury or death.
(e) Preemption
No State may establish or enforce a law which
prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such
civil action is not barred by this part.
(July 1, 1944, ch. 373, title XXI, § 2122, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3773; amended Pub. L. 100–203, title IV,
§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (b)(2), is act June 25, 1938, ch. 675, 52 Stat.

§ 300aa–23

1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.
CODIFICATION
In subsecs. (b)(1), (c), ‘‘October 1, 1988’’ was substituted for ‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as amended, set
out as an Effective Date note under section 300aa–1 of
this title.
AMENDMENTS
1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted
‘‘effective date of this subpart’’ for ‘‘effective date of
this part’’.

§ 300aa–23. Trial
(a) General rule
A civil action against a vaccine manufacturer
for damages for a vaccine-related injury or
death associated with the administration of a
vaccine after October 1, 1988, which is not barred
by section 300aa–11(a)(2) of this title shall be
tried in three stages.
(b) Liability
The first stage of such a civil action shall be
held to determine if a vaccine manufacturer is
liable under section 300aa–22 of this title.
(c) General damages
The second stage of such a civil action shall be
held to determine the amount of damages (other
than punitive damages) a vaccine manufacturer
found to be liable under section 300aa–22 of this
title shall be required to pay.
(d) Punitive damages
(1) If sought by the plaintiff, the third stage of
such an action shall be held to determine the
amount of punitive damages a vaccine manufacturer found to be liable under section 300aa–22 of
this title shall be required to pay.
(2) If in such an action the manufacturer
shows that it complied, in all material respects,
with all requirements under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
and this chapter applicable to the vaccine and
related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive
damages unless the manufacturer engaged in—
(A) fraud or intentional and wrongful withholding of information from the Secretary
during any phase of a proceeding for approval
of the vaccine under section 262 of this title,
(B) intentional and wrongful withholding of
information relating to the safety or efficacy
of the vaccine after its approval, or
(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
which activity related to the vaccine-related injury or death for which the civil action was
brought.
(e) Evidence
In any stage of a civil action, the Vaccine Injury Table, any finding of fact or conclusion of
law of the United States Court of Federal
Claims or a special master in a proceeding on a
petition filed under section 300aa–11 of this title
and the final judgment of the United States

§ 300aa–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Court of Federal Claims and subsequent appellate review on such a petition shall not be admissible.
(July 1, 1944, ch. 373, title XXI, § 2123, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3774; amended Pub. L. 100–203, title IV,
§§ 4302(b)(1), 4307(9), Dec. 22, 1987, 101 Stat.
1330–221, 1330–225; Pub. L. 101–239, title VI,
§ 6601(o), Dec. 19, 1989, 103 Stat. 2292; Pub. L.
102–572, title IX, § 902(b)(1), Oct. 29, 1992, 106 Stat.
4516.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (d)(2), is act June 25, 1938, ch. 675, 52 Stat.
1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.
CODIFICATION
In subsec. (a), ‘‘October 1, 1988’’ substituted for ‘‘the
effective date of this subpart’’ on authority of section
323 of Pub. L. 99–660, as amended, set out as an Effective
Date note under section 300aa–1 of this title.
AMENDMENTS
1992—Subsec. (e). Pub. L. 102–572 substituted ‘‘United
States Court of Federal Claims’’ for ‘‘United States
Claims Court’’ in two places.
1989—Subsec. (e). Pub. L. 101–239 substituted ‘‘finding
of fact or conclusion of law’’ for ‘‘finding’’, ‘‘special
master’’ for ‘‘master appointed by such court’’, and directed substitution of ‘‘the United States Claims Court
and subsequent appellate review’’ for ‘‘a district court
of the United States’’ which was executed by inserting
‘‘and subsequent appellate review’’ after ‘‘the United
States Claims Court’’ the second place it appeared to
reflect the probable intent of Congress and the amendment by Pub. L. 100–203, § 4307(a), see 1987 Amendment
note below.
1987—Subsec. (a). Pub. L. 100–203, § 4302(b)(1), substituted ‘‘effective date of this subpart’’ for ‘‘effective
date of this part’’.
Subsec. (e). Pub. L. 100–203, § 4307(9), substituted ‘‘the
United States Claims Court’’ for ‘‘a district court of
the United States’’ in two places.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–572 effective Oct. 29, 1992,
see section 911 of Pub. L. 102–572, set out as a note
under section 171 of Title 28, Judiciary and Judicial
Procedure.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.
SUBPART C—ASSURING A SAFER CHILDHOOD
VACCINATION PROGRAM IN UNITED STATES

§ 300aa–25. Recording and reporting of information
(a) General rule
Each health care provider who administers a
vaccine set forth in the Vaccine Injury Table to
any person shall record, or ensure that there is
recorded, in such person’s permanent medical
record (or in a permanent office log or file to
which a legal representative shall have access

Page 1162

upon request) with respect to each such vaccine—
(1) the date of administration of the vaccine,
(2) the vaccine manufacturer and lot number
of the vaccine,
(3) the name and address and, if appropriate,
the title of the health care provider administering the vaccine, and
(4) any other identifying information on the
vaccine required pursuant to regulations promulgated by the Secretary.
(b) Reporting
(1) Each health care provider and vaccine manufacturer shall report to the Secretary—
(A) the occurrence of any event set forth in
the Vaccine Injury Table, including the events
set forth in section 300aa–14(b) of this title
which occur within 7 days of the administration of any vaccine set forth in the Table or
within such longer period as is specified in the
Table or section,
(B) the occurrence of any contraindicating
reaction to a vaccine which is specified in the
manufacturer’s package insert, and
(C) such other matters as the Secretary may
by regulation require.
Reports of the matters referred to in subparagraphs (A) and (B) shall be made beginning 90
days after December 22, 1987. The Secretary
shall publish in the Federal Register as soon as
practicable after such date a notice of the reporting requirement.
(2) A report under paragraph (1) respecting a
vaccine shall include the time periods after the
administration of such vaccine within which
vaccine-related illnesses, disabilities, injuries,
or conditions, the symptoms and manifestations
of such illnesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer
and lot number of the vaccine.
(3) The Secretary shall issue the regulations
referred to in paragraph (1)(C) within 180 days of
December 22, 1987.
(c) Release of information
(1) Information which is in the possession of
the Federal Government and State and local
governments under this section and which may
identify an individual shall not be made available under section 552 of title 5, or otherwise, to
any person except—
(A) the person who received the vaccine, or
(B) the legal representative of such person.
(2) For purposes of paragraph (1), the term ‘‘information which may identify an individual’’
shall be limited to the name, street address, and
telephone number of the person who received
the vaccine and of that person’s legal representative and the medical records of such person relating to the administration of the vaccine, and
shall not include the locality and State of vaccine administration, the name of the health care
provider who administered the vaccine, the date
of the vaccination, or information concerning
any reported illness, disability, injury, or condition resulting from the administration of the
vaccine, any symptom or manifestation of such
illness, disability, injury, or condition, or death
resulting from the administration of the vaccine.

Page 1163

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Except as provided in paragraph (1), all information reported under this section shall be
available to the public.
(July 1, 1944, ch. 373, title XXI, § 2125, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3774; amended Pub. L. 100–203, title IV,
§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
CODIFICATION
In subsec. (b)(1), (3), ‘‘December 22, 1987’’ was substituted for ‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as amended, set
out as an Effective Date note under section 300aa–1 of
this title.
AMENDMENTS
1987—Subsec. (b)(1), (3). Pub. L. 100–203 substituted
‘‘effective date of this subpart’’ for ‘‘effective date of
this part’’.
EFFECTIVE DATE
Subpart effective Dec. 22, 1987, see section 323 of Pub.
L. 99–660, set out as a note under section 300aa–1 of this
title.

§ 300aa–26. Vaccine information
(a) General rule
Not later than 1 year after December 22, 1987,
the Secretary shall develop and disseminate vaccine information materials for distribution by
health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury
Table. Such materials shall be published in the
Federal Register and may be revised.
(b) Development and revision of materials
Such materials shall be developed or revised—
(1) after notice to the public and 60 days of
comment thereon, and
(2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate
health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
(c) Information requirements
The information in such materials shall be
based on available data and information, shall
be presented in understandable terms and shall
include—
(1) a concise description of the benefits of
the vaccine,
(2) a concise description of the risks associated with the vaccine,
(3) a statement of the availability of the National Vaccine Injury Compensation Program,
and
(4) such other relevant information as may
be determined by the Secretary.
(d) Health care provider duties
On and after a date determined by the Secretary which is—
(1) after the Secretary develops the information materials required by subsection (a) of
this section, and
(2) not later than 6 months after the date
such materials are published in the Federal
Register,
each health care provider who administers a
vaccine set forth in the Vaccine Injury Table

§ 300aa–26

shall provide to the legal representatives of any
child or to any other individual to whom such
provider intends to administer such vaccine a
copy of the information materials developed
pursuant to subsection (a) of this section, supplemented with visual presentations or oral explanations, in appropriate cases. Such materials
shall be provided prior to the administration of
such vaccine.
(July 1, 1944, ch. 373, title XXI, § 2126, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3775; amended Pub. L. 100–203, title IV,
§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221; Pub.
L. 101–239, title VI, § 6601(p), Dec. 19, 1989, 103
Stat. 2292; Pub. L. 102–531, title III, § 312(d)(15),
Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103–183, title
VII, § 708, Dec. 14, 1993, 107 Stat. 2242.)
CODIFICATION
In subsec. (a), ‘‘December 22, 1987’’ substituted for
‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.
AMENDMENTS
1993—Subsec. (a). Pub. L. 103–183, § 708(c), inserted ‘‘or
to any other individual’’ after ‘‘to the legal representatives of any child’’.
Subsec. (b). Pub. L. 103–183, § 708(a), struck out ‘‘by
rule’’ after ‘‘revised’’ in introductory provisions and
substituted ‘‘and 60’’ for ‘‘, opportunity for a public
hearing, and 90’’ in par. (1).
Subsec. (c). Pub. L. 103–183, § 708(b), inserted in introductory provisions ‘‘shall be based on available data
and information,’’ after ‘‘such materials’’, added pars.
(1) to (4), and struck out former pars. (1) to (10) which
read as follows:
‘‘(1) the frequency, severity, and potential long-term
effects of the disease to be prevented by the vaccine,
‘‘(2) the symptoms or reactions to the vaccine which,
if they occur, should be brought to the immediate attention of the health care provider,
‘‘(3) precautionary measures legal representatives
should take to reduce the risk of any major adverse reactions to the vaccine that may occur,
‘‘(4) early warning signs or symptoms to which legal
representatives should be alert as possible precursors
to such major adverse reactions,
‘‘(5) a description of the manner in which legal representatives should monitor such major adverse reactions, including a form on which reactions can be recorded to assist legal representatives in reporting information to appropriate authorities,
‘‘(6) a specification of when, how, and to whom legal
representatives should report any major adverse reaction,
‘‘(7) the contraindications to (and bases for delay of)
the administration of the vaccine,
‘‘(8) an identification of the groups, categories, or
characteristics of potential recipients of the vaccine
who may be at significantly higher risk of major adverse reaction to the vaccine than the general population,
‘‘(9) a summary of—
‘‘(A) relevant Federal recommendations concerning
a complete schedule of childhood immunizations, and
‘‘(B) the availability of the Program, and
‘‘(10) such other relevant information as may be determined by the Secretary.’’
Subsec. (d). Pub. L. 103–183, § 708(c), (d), in concluding
provisions, inserted ‘‘or to any other individual’’ after
‘‘to the legal representatives of any child’’, substituted
‘‘supplemented with visual presentations or oral explanations, in appropriate cases’’ for ‘‘or other written information which meets the requirements of this section’’, and struck out ‘‘or other information’’ after
‘‘Such materials’’.

§ 300aa–27

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1992—Subsec. (b)(2). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’.
1989—Subsec. (c)(9). Pub. L. 101–239 amended par. (9)
generally. Prior to amendment, par. (9) read as follows:
‘‘a summary of relevant State and Federal laws concerning the vaccine, including information on—
‘‘(A) the number of vaccinations required for school
attendance and the schedule recommended for such
vaccinations, and
‘‘(B) the availability of the Program, and’’.
1987—Subsec. (a). Pub. L. 100–203 substituted ‘‘effective date of this subpart’’ for ‘‘effective date of this
part’’.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–27. Mandate for safer childhood vaccines
(a) General rule
In the administration of this part and other
pertinent laws under the jurisdiction of the Secretary, the Secretary shall—
(1) promote the development of childhood
vaccines that result in fewer and less serious
adverse reactions than those vaccines on the
market on December 22, 1987, and promote the
refinement of such vaccines, and
(2) make or assure improvements in, and
otherwise use the authorities of the Secretary
with respect to, the licensing, manufacturing,
processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or
batches, of vaccines, and research on vaccines,
in order to reduce the risks of adverse reactions to vaccines.
(b) Task force
(1) The Secretary shall establish a task force
on safer childhood vaccines which shall consist
of the Director of the National Institutes of
Health, the Commissioner of the Food and Drug
Administration, and the Director of the Centers
for Disease Control.
(2) The Director of the National Institutes of
Health shall serve as chairman of the task force.
(3) In consultation with the Advisory Commission on Childhood Vaccines, the task force shall
prepare recommendations to the Secretary concerning implementation of the requirements of
subsection (a) of this section.
(c) Report
Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy
and Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) of this
section during the preceding 2-year period.
(July 1, 1944, ch. 373, title XXI, § 2127, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3777; amended Pub. L. 100–203, title IV,

Page 1164

§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221; Pub.
L. 101–239, title VI, § 6601(q), Dec. 19, 1989, 103
Stat. 2292.)
CODIFICATION
In subsecs. (a)(1), (c), ‘‘December 22, 1987’’ substituted
for ‘‘the effective date of this subpart’’ on authority of
section 323 of Pub. L. 99–660, as amended, set out as an
Effective Date note under section 300aa–1 of this title.
AMENDMENTS
1989—Subsecs. (b), (c). Pub. L. 101–239 added subsec.
(b) and redesignated former subsec. (b) as (c).
1987—Subsecs. (a)(1), (b). Pub. L. 100–203 substituted
‘‘effective date of this subpart’’ for ‘‘effective date of
this part’’.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.
EFFECTIVE DATE OF 1989 AMENDMENT
For applicability of amendments by Pub. L. 101–239 to
petitions filed after Dec. 19, 1989, petitions currently
pending in which the evidentiary record is closed, and
petitions currently pending in which the evidentiary
record is not closed, with provision for an immediate
suspension for 30 days of all pending cases, see section
6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

§ 300aa–28. Manufacturer recordkeeping and reporting
(a) General rule
Each vaccine manufacturer of a vaccine set
forth in the Vaccine Injury Table or any other
vaccine the administration of which is mandated by the law or regulations of any State,
shall, with respect to each batch, lot, or other
quantity manufactured or licensed after December 22, 1987—
(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each
batch, lot, or other quantity of such vaccine,
including the identification of any significant
problems encountered in the production, testing, or handling of such batch, lot, or other
quantity,
(2) if a safety test on such batch, lot, or
other quantity indicates a potential imminent
or substantial public health hazard is presented, report to the Secretary within 24 hours
of such safety test which the manufacturer (or
manufacturer’s representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or

Page 1165

TITLE 42—THE PUBLIC HEALTH AND WELFARE

other quantity tested, whether the batch, lot,
or other quantity tested is the product of repooling or reworking of previous batches, lots,
or other quantities (and, if so, the identity of
the previous batches, lots, or other quantities
which were repooled or reworked), the complete test results, and the name and address of
the person responsible for conducting the test,
(3) include with each such report a certification signed by a responsible corporate official that such report is true and complete, and
(4) prepare, maintain, and upon request submit to the Secretary product distribution
records for each such vaccine by batch, lot, or
other quantity number.
(b) Sanction
Any vaccine manufacturer who intentionally
destroys, alters, falsifies, or conceals any record
or report required under paragraph (1) or (2) of
subsection (a) of this section shall—
(1) be subject to a civil penalty of up to
$100,000 per occurrence, or
(2) be fined $50,000 or imprisoned for not
more than 1 year, or both.
Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who
directed that such record or report be destroyed,
altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an
agent, employee, or representative. Each act of
destruction, alteration, falsification, or concealment shall be treated as a separate occurrence.
(July 1, 1944, ch. 373, title XXI, § 2128, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3777; amended Pub. L. 100–203, title IV,
§ 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
CODIFICATION
In subsec. (a), ‘‘December 22, 1987’’ substituted for
‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.
AMENDMENTS
1987—Subsec. (a). Pub. L. 100–203 substituted ‘‘effective date of this subpart’’ for ‘‘effective date of this
part’’.
SUBPART D—GENERAL PROVISIONS

§ 300aa–31. Citizen’s actions
(a) General rule
Except as provided in subsection (b) of this
section, any person may commence in a district
court of the United States a civil action on such
person’s own behalf against the Secretary where
there is alleged a failure of the Secretary to perform any act or duty under this part.
(b) Notice
No action may be commenced under subsection (a) of this section before the date which
is 60 days after the person bringing the action
has given written notice of intent to commence
such action to the Secretary.
(c) Costs of litigation
The court, in issuing any final order in any action under this section, may award costs of liti-

§ 300aa–33

gation (including reasonable attorney and expert witness fees) to any plaintiff who substantially prevails on one or more significant issues
in the action.
(July 1, 1944, ch. 373, title XXI, § 2131, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3778; amended Pub. L. 100–203, title IV,
§ 4305, Dec. 22, 1987, 101 Stat. 1330–224.)
AMENDMENTS
1987—Subsec. (c). Pub. L. 100–203, which directed that
subsec. (c) be amended by substituting ‘‘to any plaintiff
who substantially prevails on one or more significant
issues in the action’’ for ‘‘to any party, whenever the
court determines that such award is appropriate’’, was
executed by making the substitution for ‘‘to any party,
whenever the court determines such award is appropriate’’, to reflect the probable intent of Congress.
EFFECTIVE DATE
Subpart effective Dec. 22, 1987, see section 323 of Pub.
L. 99–660, set out as a note under section 300aa–1 of this
title.

§ 300aa–32. Judicial review
A petition for review of a regulation under
this part may be filed in a court of appeals of
the United States within 60 days from the date
of the promulgation of the regulation or after
such date if such petition is based solely on
grounds arising after such 60th day.
(July 1, 1944, ch. 373, title XXI, § 2132, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3778.)
§ 300aa–33. Definitions
For purposes of this part:
(1) The term ‘‘health care provider’’ means
any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities)
under whose authority a vaccine set forth in
the Vaccine Injury Table is administered.
(2) The term ‘‘legal representative’’ means a
parent or an individual who qualifies as a legal
guardian under State law.
(3) The term ‘‘manufacturer’’ means any corporation, organization, or institution, whether
public or private (including Federal, State,
and local departments, agencies, and instrumentalities), which manufactures, imports,
processes, or distributes under its label any
vaccine set forth in the Vaccine Injury Table,
except that, for purposes of section 300aa–28 of
this title, such term shall include the manufacturer of any other vaccine covered by that
section. The term ‘‘manufacture’’ means to
manufacture, import, process, or distribute a
vaccine.
(4) The term ‘‘significant aggravation’’
means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by
substantial deterioration of health.
(5) The term ‘‘vaccine-related injury or
death’’ means an illness, injury, condition, or
death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness,
injury, condition, or death associated with an

§ 300aa–34

TITLE 42—THE PUBLIC HEALTH AND WELFARE

adulterant or contaminant intentionally
added to such a vaccine.
(6)(A) The term ‘‘Advisory Commission on
Childhood Vaccines’’ means the Commission
established under section 300aa–19 of this title.
(B) The term ‘‘Vaccine Injury Table’’ means
the table set out in section 300aa–14 of this
title.
(July 1, 1944, ch. 373, title XXI, § 2133, as added
Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100
Stat. 3778; amended Pub. L. 107–296, title XVII,
§§ 1714–1716, Nov. 25, 2002, 116 Stat. 2320, 2321; Pub.
L. 108–7, div. L, § 102(a), Feb. 20, 2003, 117 Stat.
528.)
AMENDMENTS
2003—Pars. (3), (5), (7). Pub. L. 108–7 repealed Pub. L.
107–296, §§ 1714–1717, and provided that this chapter shall
be applied as if the sections repealed had never been enacted. See 2002 Amendment notes below.
2002—Par. (3). Pub. L. 107–296, § 1714, which directed
amendment of first sentence by substituting ‘‘any vaccine set forth in the Vaccine Injury table, including
any component or ingredient of any such vaccine’’ for
‘‘under its label any vaccine set forth in the Vaccine
Injury Table’’ and of second sentence by inserting ‘‘including any component or ingredient of any such vaccine’’ before period at end, was repealed by Pub. L.
108–7.
Par. (5). Pub. L. 107–296, § 1715, which directed insertion of ‘‘For purposes of the preceding sentence, an
adulterant or contaminant shall not include any component or ingredient listed in a vaccine’s product license application or product label.’’ at end, was repealed by Pub. L. 108–7.
Par. (7). Pub. L. 107–296, § 1716, which directed addition of par. (7), was repealed by Pub. L. 108–7, § 102(a).
Par. (7) read as follows: ‘‘The term ‘vaccine’ means any
preparation or suspension, including but not limited to
a preparation or suspension containing an attenuated
or inactive microorganism or subunit thereof or toxin,
developed or administered to produce or enhance the
body’s immune response to a disease or diseases and includes all components and ingredients listed in the
vaccines’s product license application and product
label.’’
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107–296, title XVII, § 1717, Nov. 25, 2002, 116
Stat. 2321, which provided that the amendments made
by sections 1714, 1715, and 1716 (amending this section)
shall apply to all actions or proceedings pending on or
after Nov. 25, 2002, unless a court of competent jurisdiction has entered judgment (regardless of whether the
time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding, was repealed by Pub. L. 108–7, div. L, § 102(a), Feb. 20, 2003, 117
Stat. 528.
CONSTRUCTION OF AMENDMENTS
Pub. L. 108–7, div. L, § 102(b), (c), Feb. 20, 2003, 117
Stat. 528, provided that:
‘‘(b) APPLICATION OF THE PUBLIC HEALTH SERVICE
ACT.—The Public Health Service Act (42 U.S.C. 201 et
seq.) shall be applied and administered as if the sections repealed by subsection (a) [repealing sections 1714
to 1717 of Pub. L. 107–296, which amended this section
and enacted provisions set out as a note under this section] had never been enacted.
‘‘(c) RULE OF CONSTRUCTION.—No inference shall be
drawn from the enactment of sections 1714 through 1717
of the Homeland Security Act of 2002 (Public Law
107–296), or from this repeal [repealing sections 1714 to
1717 of Pub. L. 107–296], regarding the law prior to enactment of sections 1714 through 1717 of the Homeland
Security Act of 2002 (Public Law 107–296) [Nov. 25, 2002].
Further, no inference shall be drawn that subsection (a)

Page 1166

or (b) affects any change in that prior law, or that
Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02–392V (October 11, 2002),
was incorrectly decided.’’

§ 300aa–34. Termination of program
(a) Reviews
The Secretary shall review the number of
awards of compensation made under the program to petitioners under section 300aa–11 of
this title for vaccine-related injuries and deaths
associated with the administration of vaccines
on or after December 22, 1987, as follows:
(1) The Secretary shall review the number of
such awards made in the 12-month period beginning on December 22, 1987.
(2) At the end of each 3-month period beginning after the expiration of the 12-month period referred to in paragraph (1) the Secretary
shall review the number of such awards made
in the 3-month period.
(b) Report
(1) If in conducting a review under subsection
(a) of this section the Secretary determines that
at the end of the period reviewed the total number of awards made by the end of that period and
accepted under section 300aa–21(a) of this title
exceeds the number of awards listed next to the
period reviewed in the table in paragraph (2)—
(A) the Secretary shall notify the Congress
of such determination, and
(B) beginning 180 days after the receipt by
Congress of a notification under paragraph (1),
no petition for a vaccine-related injury or
death associated with the administration of a
vaccine on or after December 22, 1987, may be
filed under section 300aa–11 of this title.
Section 300aa–11(a) of this title and subpart B of
this part shall not apply to civil actions for
damages for a vaccine-related injury or death
for which a petition may not be filed because of
subparagraph (B).
(2) The table referred to in paragraph (1) is as
follows:
Total number of awards
by the end of the period
Period reviewed:
reviewed
12 months after December 22, 1987 ................
150
13th through the 15th month after December
22, 1987 ........................................................
188
16th through the 18th month after December
22, 1987 ........................................................
225
19th through the 21st month after December
22, 1987 ........................................................
263
22nd through the 24th month after December
22, 1987 ........................................................
300
25th through the 27th month after December
22, 1987 ........................................................
338
28th through the 30th month after December
22, 1987 ........................................................
375
31st through the 33rd month after December
22, 1987 ........................................................
413
34th through the 36th month after December
22, 1987 ........................................................
450
37th through the 39th month after December
22, 1987 ........................................................
488
40th through the 42nd month after December
22, 1987 ........................................................
525
43rd through the 45th month after December
22, 1987 ........................................................
563
46th through the 48th month after December
22, 1987 ........................................................
600.

Page 1167

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XXI, § 2134, as added
Pub. L. 100–203, title IV, § 4303(f), Dec. 22, 1987, 101
Stat. 1330–222.)
CODIFICATION
In subsecs. (a) and (b), ‘‘December 22, 1987’’ substituted for ‘‘the effective date of this subpart’’ on authority of section 323 of Pub. L. 99–660, as amended, set
out as an Effective Date note under section 300aa–1 of
this title.

SUBCHAPTER
XX—REQUIREMENTS
FOR
CERTAIN GROUP HEALTH PLANS FOR
CERTAIN STATE AND LOCAL EMPLOYEES
§ 300bb–1. State and local governmental group
health plans must provide continuation coverage to certain individuals
(a) In general
In accordance with regulations which the Secretary shall prescribe, each group health plan
that is maintained by any State that receives
funds under this chapter, by any political subdivision of such a State, or by any agency or instrumentality of such a State or political subdivision, shall provide, in accordance with this
subchapter, that each qualified beneficiary who
would lose coverage under the plan as a result of
a qualifying event is entitled, under the plan, to
elect, within the election period, continuation
coverage under the plan.
(b) Exception for certain plans
Subsection (a) of this section shall not apply
to—
(1) any group health plan for any calendar
year if all employers maintaining such plan
normally employed fewer than 20 employees
on a typical business day during the preceding
calendar year, or
(2) any group health plan maintained for employees by the government of the District of
Columbia or any territory or possession of the
United States or any agency or instrumentality.
(July 1, 1944, ch. 373, title XXII, § 2201, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 232; amended Pub. L. 101–239, title VI,
§ 6801(a)(1), Dec. 19, 1989, 103 Stat. 2296.)
AMENDMENTS
1989—Subsec. (b). Pub. L. 101–239 struck out at end
‘‘Under regulations, rules similar to the rules of subsections (a) and (b) of section 52 of title 26 (relating to
employers under common control) shall apply for purposes of paragraph (1).’’
EFFECTIVE DATE OF 1989 AMENDMENT
Section 6801(a)(2) of Pub. L. 101–239 provided that:
‘‘The amendment made by paragraph (1) [amending this
section] shall apply to years beginning after December
31, 1986.’’
EFFECTIVE DATE
Section 10003(b) of Pub. L. 99–272 provided that:
‘‘(1) GENERAL RULE.—The amendments made by this
section [enacting this subchapter] shall apply to plan
years beginning on or after July 1, 1986.
‘‘(2) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group health plan maintained
pursuant to one or more collective bargaining agreements between employee representatives and one or
more employers ratified before the date of the enact-

§ 300bb–2

ment of this Act [Apr. 7, 1986], the amendments made
by this section shall not apply to plan years beginning
before the later of—
‘‘(A) the date on which the last of the collective
bargaining agreements relating to the plan terminates (determined without regard to any extension
thereof agreed to after the date of the enactment of
this Act), or
‘‘(B) January 1, 1987.
For purposes of subparagraph (A), any plan amendment
made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this section shall
not be treated as a termination of such collective bargaining agreement.’’

§ 300bb–2. Continuation coverage
For purposes of section 300bb–1 of this title,
the term ‘‘continuation coverage’’ means coverage under the plan which meets the following
requirements:
(1) Type of benefit coverage
The coverage must consist of coverage
which, as of the time the coverage is being
provided, is identical to the coverage provided
under the plan to similarly situated beneficiaries under the plan with respect to whom
a qualifying event has not occurred. If coverage is modified under the plan for any group
of similarly situated beneficiaries, such coverage shall also be modified in the same manner for all individuals who are qualified beneficiaries under the plan pursuant to this part 1
in connection with such group.
(2) Period of coverage
The coverage must extend for at least the
period beginning on the date of the qualifying
event and ending not earlier than the earliest
of the following:
(A) Maximum required period
(i) General rule for terminations and reduced hours
In the case of a qualifying event described in section 300bb–3(2) of this title,
except as provided in clause (ii), the date
which is 18 months after the date of the
qualifying event.
(ii) Special rule for multiple qualifying
events
If a qualifying event occurs during the 18
months after the date of a qualifying event
described in section 300bb–3(2) of this title,
the date which is 36 months after the date
of the qualifying event described in section
300bb–3(2) of this title.
(iii) General rule for other qualifying
events
In the case of a qualifying event not described in section 300bb–3(2) of this title,
the date which is 36 months after the date
of the qualifying event.
(iv) Special rule for TAA-eligible individuals
In the case of a qualifying event described in section 300bb–3(2) of this title
with respect to a covered employee who is
1 So

in original. This subchapter is not divided into parts.

§ 300bb–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(as of the date that the period of coverage
would, but for this clause or clause (v),
otherwise terminate under clause (i) or
(ii)) a TAA-eligible individual (as defined
in section 300bb–5(b)(4)(B) of this title), the
period of coverage shall not terminate by
reason of clause (i) or (ii), as the case may
be, before the later of the date specified in
such clause or the date on which such individual ceases to be such a TAA-eligible individual. The preceding sentence shall not
require any period of coverage to extend
beyond February 12, 2011.
(v) Medicare entitlement followed by qualifying event
In the case of a qualifying event described in section 300bb–3(2) of this title
that occurs less than 18 months after the
date the covered employee became entitled
to benefits under title XVIII of the Social
Security Act [42 U.S.C. 1395 et seq.], the
period of coverage for qualified beneficiaries other than the covered employee
shall not terminate under this subparagraph before the close of the 36-month period beginning on the date the covered employee became so entitled.
(vi) Special rule for disability
In the case of a qualified beneficiary who
is determined, under title II or XVI of the
Social Security Act [42 U.S.C. 401 et seq.,
1381 et seq.], to have been disabled at any
time during the first 60 days of continuation coverage under this subchapter, any
reference in clause (i) or (ii) to 18 months
is deemed a reference to 29 months (with
respect to all qualified beneficiaries), but
only if the qualified beneficiary has provided notice of such determination under
section 300bb–6(3) of this title before the
end of such 18 months.
(B) End of plan
The date on which the employer ceases to
provide any group health plan to any employee.
(C) Failure to pay premium
The date on which coverage ceases under
the plan by reason of a failure to make timely payment of any premium required under
the plan with respect to the qualified beneficiary. The payment of any premium (other
than any payment referred to in the last
sentence of paragraph (3)) shall be considered to be timely if made within 30 days
after the date due or within such longer period as applies to or under the plan.
(D) Group health plan coverage or medicare
entitlement
The date on which the qualified beneficiary first becomes, after the date of the
election—
(i) covered under any other group health
plan (as an employee or otherwise) which
does not contain any exclusion or limitation with respect to any preexisting condition of such beneficiary (other than such
an exclusion or limitation which does not
apply to (or is satisfied by) such bene-

Page 1168

ficiary by reason of chapter 100 of title 26,
part 7 of subtitle B of title I of the Employee Retirement Income Security Act of
1974 [29 U.S.C. 1181 et seq.], or subchapter
XXV of this chapter), or
(ii) entitled to benefits under title XVIII
of the Social Security Act [42 U.S.C. 1395
et seq.].
(E) Termination of extended coverage for
disability
In the case of a qualified beneficiary who
is disabled at any time during the first 60
days of continuation coverage under this
subchapter, the month that begins more
than 30 days after the date of the final determination under title II or XVI of the Social
Security Act [42 U.S.C. 401 et seq., 1381 et
seq.] that the qualified beneficiary is no
longer disabled.
(3) Premium requirements
The plan may require payment of a premium
for any period of continuation coverage, except that such premium—
(A) shall not exceed 102 percent of the applicable premium for such period, and
(B) may, at the election of the payor, be
made in monthly installments.
In no event may the plan require the payment
of any premium before the day which is 45
days after the day on which the qualified beneficiary made the initial election for continuation coverage.2 In the case of an individual
described in the last sentence of paragraph
(2)(A), any reference in subparagraph (A) of
this paragraph to ‘‘102 percent’’ is deemed a
reference to ‘‘150 percent’’ for any month after
the 18th month of continuation coverage described in clause (i) or (ii) of paragraph (2)(A).
(4) No requirement of insurability
The coverage may not be conditioned upon,
or discriminate on the basis of lack of, evidence of insurability.
(5) Conversion option
In the case of a qualified beneficiary whose
period of continuation coverage expires under
paragraph (2)(A), the plan must, during the
180-day period ending on such expiration date,
provide to the qualified beneficiary the option
of enrollment under a conversion health plan
otherwise generally available under the plan.
(July 1, 1944, ch. 373, title XXII, § 2202, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 233; amended Pub. L. 99–514, title XVIII,
§ 1895(d)(1)(C), (2)(C), (3)(C), (4)(C), Oct. 22, 1986,
100 Stat. 2937–2939; Pub. L. 101–239, title VI,
§§ 6702(a), (b), 6801(b)(1)(A), (2)(A), (3)(A), Dec. 19,
1989, 103 Stat. 2295, 2297; Pub. L. 104–188, title I,
§ 1704(g)(1)(C), Aug. 20, 1996, 110 Stat. 1880; Pub.
L. 104–191, title IV, § 421(a)(1), Aug. 21, 1996, 110
Stat. 2087; Pub. L. 111–5, div. B, title I, § 1899F(c),
Feb. 17, 2009, 123 Stat. 429; Pub. L. 111–344, title
I, § 116(c), Dec. 29, 2010, 124 Stat. 3616.)
REFERENCES IN TEXT
The Social Security Act, referred to in par. (2)(A)(v),
(vi), (D)(ii), and (E), is act Aug. 14, 1935, ch. 531, 49 Stat.
2 See

1989 Amendment note below.

Page 1169

TITLE 42—THE PUBLIC HEALTH AND WELFARE

620. Titles II, XVI, and XVIII of the Social Security Act
are classified generally to subchapters II (§ 401 et seq.),
XVI (§ 1381 et seq.), and XVIII (§ 1395 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.
The Employee Retirement Income Security Act of
1974, referred to in par. (2)(D)(i), is Pub. L. 93–406, Sept.
2, 1974, 88 Stat. 829. Part 7 of subtitle B of title I of the
Act is classified generally to part 7 (§ 1181 et seq.) of
subtitle B of subchapter I of chapter 18 of Title 29,
Labor. For complete classification of this Act to the
Code, see Short Title note set out under section 1001 of
Title 29 and Tables.
AMENDMENTS
2010—Par. (2)(A)(iv). Pub. L. 111–344 substituted ‘‘February 12, 2011’’ for ‘‘December 31, 2010’’.
2009—Par. (2)(A). Pub. L. 111–5, § 1899F(c)(1), designated concluding provisions as cl. (v) and inserted
heading.
Par. (2)(A)(iv) to (vi). Pub. L. 111–5, § 1899F(c)(2), added
cl. (iv) and redesignated former cls. (iv) and (v) as (v)
and (vi), respectively.
1996—Par. (2)(A). Pub. L. 104–191, § 421(a)(1)(A)(ii)(IV),
inserted ‘‘(with respect to all qualified beneficiaries)’’
after ‘‘29 months’’ in concluding provisions.
Pub. L. 104–191, § 421(a)(1)(A)(ii)(III), which directed
amendment of concluding provisions by striking ‘‘with
respect to such event,’’, was executed by striking that
phrase, which did not contain a comma at end, before
‘‘is deemed a reference’’ to reflect the probable intent
of Congress.
Pub. L. 104–191, § 421(a)(1)(A)(ii)(I), (II), in concluding
provisions, substituted ‘‘a qualified beneficiary’’ for
‘‘an individual’’ and ‘‘at any time during the first 60
days of continuation coverage under this subchapter’’
for ‘‘at the time of a qualifying event described in section 300bb–3(2) of this title’’.
Pub. L. 104–191, § 421(a)(1)(A)(i), transferred sentence
following cl. (iii) to appear as concluding provisions following cl. (iv).
Par. (2)(A)(iv). Pub. L. 104–188 amended heading and
text of cl. (iv) generally. Prior to amendment, text read
as follows: ‘‘In the case of an event described in section
300bb–3(4) of this title (without regard to whether such
event is a qualifying event), the period of coverage for
qualified beneficiaries other than the covered employee
for such event or any subsequent qualifying event shall
not terminate before the close of the 36-month period
beginning on the date the covered employee becomes
entitled to benefits under title XVIII of the Social Security Act.’’
Par. (2)(D)(i). Pub. L. 104–191, § 421(a)(1)(B), inserted
‘‘(other than such an exclusion or limitation which
does not apply to (or is satisfied by) such beneficiary by
reason of chapter 100 of title 26, part 7 of subtitle B of
title I of the Employee Retirement Income Security
Act of 1974, or subchapter XXV of this chapter)’’ before
‘‘, or’’.
Par. (2)(E). Pub. L. 104–191, § 421(a)(1)(C), substituted
‘‘at any time during the first 60 days of continuation
coverage under this subchapter’’ for ‘‘at the time of a
qualifying event described in section 300bb–3(2) of this
title’’.
1989—Par. (2)(A). Pub. L. 101–239, § 6702(a)(1), inserted
after cl. (iii) ‘‘In the case of an individual who is determined, under title II or XVI of the Social Security Act,
to have been disabled at the time of a qualifying event
described in section 300bb–3(2) of this title, any reference in clause (i) or (ii) to 18 months with respect to
such event is deemed a reference to 29 months, but only
if the qualified beneficiary has provided notice of such
determination under section 300bb–6(3) of this title before the end of such 18 months.’’
Par. (2)(A)(iv). Pub. L. 101–239, § 6801(b)(1)(A), added cl.
(iv).
Par. (2)(D). Pub. L. 101–239, § 6801(b)(2)(A), substituted
‘‘entitlement’’ for ‘‘eligibility’’ in heading and inserted
‘‘which does not contain any exclusion or limitation

§ 300bb–2

with respect to any preexisting condition of such beneficiary’’ after ‘‘or otherwise)’’ in cl. (i).
Par. (2)(E). Pub. L. 101–239, § 6702(a)(2), added subpar.
(E).
Par. (3). Pub. L. 101–239, § 6801(b)(3)(A), which directed
the general amendment of the concluding provision was
executed by amending the first sentence of the concluding provision generally to reflect the probable intent of
Congress and amendment of concluding provision by
Pub. L. 101–239, § 6702(b). Prior to amendment, first sentence of the concluding provision read as follows: ‘‘If an
election is made after the qualifying event, the plan
shall permit payment for continuation coverage during
the period preceding the election to be made within 45
days of the date of the election.’’
Pub. L. 101–239, § 6702(b), inserted at end of concluding
provision ‘‘In the case of an individual described in the
last sentence of paragraph (2)(A), any reference in subparagraph (A) of this paragraph to ‘102 percent’ is
deemed a reference to ‘150 percent’ for any month after
the 18th month of continuation coverage described in
clause (i) or (ii) of paragraph (2)(A).’’ See Amendment
note above.
1986—Par. (1). Pub. L. 99–514, § 1895(d)(1)(C), inserted at
end ‘‘If coverage is modified under the plan for any
group of similarly situated beneficiaries, such coverage
shall also be modified in the same manner for all individuals who are qualified beneficiaries under the plan
pursuant to this part in connection with such group.’’
Par. (2)(A). Pub. L. 99–514, § 1895(d)(2)(C), amended
subpar. (A) generally. Prior to amendment, subpar. (A)
read as follows: ‘‘MAXIMUM PERIOD.—In the case of—
‘‘(i) a qualifying event described in section
300bb–3(2) of this title (relating to terminations and
reduced hours), the date which is 18 months after the
date of the qualifying event, and
‘‘(ii) any qualifying event not described in clause
(i), the date which is 36 months after the date of the
qualifying event.’’
Par. (2)(C). Pub. L. 99–514, § 1895(d)(3)(C), inserted at
end ‘‘The payment of any premium (other than any
payment referred to in the last sentence of paragraph
(3)) shall be considered to be timely if made within 30
days after the date due or within such longer period as
applies to or under the plan.’’
Par. (2)(D). Pub. L. 99–514, § 1895(d)(4)(C)(ii), (iii), substituted ‘‘Group health plan coverage’’ for ‘‘Reemployment’’ in heading, added cl. (i), and struck out former
cl. (i) which read as follows: ‘‘a covered employee under
any other group health plan, or’’.
Par. (2)(E). Pub. L. 99–514, § 1895(d)(4)(C)(i), struck out
subpar. (E), remarriage of spouse, which read as follows: ‘‘In the case of an individual who is a qualified
beneficiary by reason of being the spouse of a covered
employee, the date on which the beneficiary remarries
and becomes covered under a group health plan.’’
EFFECTIVE DATE OF 2010 AMENDMENT
Amendment by Pub. L. 111–344 applicable to periods
of coverage which would (without regard to such
amendment) end on or after Dec. 31, 2010, see section
116(d) of Pub. L. 111–344, set out as a note under section
4980B of Title 26, Internal Revenue Code.
EFFECTIVE DATE OF 2009 AMENDMENT
Except as otherwise provided and subject to certain
applicability provisions, amendment by Pub. L. 111–5
effective upon the expiration of the 90-day period beginning on Feb. 17, 2009, see section 1891 of Pub. L. 111–5,
set out as an Effective and Termination Dates of 2009
Amendment note under section 2271 of Title 19, Customs Duties.
Amendment by Pub. L. 111–5 applicable to periods of
coverage which would (without regard to amendment
by Pub. L. 111–5) end on or after Feb. 17, 2009, see section 1899F(d) of Pub. L. 111–5, set out as a note under
section 4980B of Title 26, Internal Revenue Code.
EFFECTIVE DATE OF 1996 AMENDMENTS
Amendment by Pub. L. 104–191 effective Jan. 1, 1997,
regardless of whether the qualifying event occurred be-

§ 300bb–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fore, on, or after such date, see section 421(d) of Pub. L.
104–191, set out as a note under section 4980B of Title 26,
Internal Revenue Code.
Amendment by Pub. L. 104–188 applicable to plan
years beginning after Dec. 31, 1989, see section 1704(g)(2)
of Pub. L. 104–188, set out as a note under section 4980B
of Title 26.
EFFECTIVE DATE OF 1989 AMENDMENT
Section 6702(d) of Pub. L. 101–239 provided that: ‘‘The
amendments made by this section [amending this section and section 300bb–6 of this title] shall apply to
plan years beginning on or after the date of the enactment of this Act [Dec. 19, 1989], regardless of whether
the qualifying event occurred before, on, or after such
date.’’
Section 6801(b)(1)(B) of Pub. L. 101–239 provided that:
‘‘The amendments made by this paragraph [amending
this section] shall apply to plan years beginning after
December 31, 1989.’’
Section 6801(b)(2)(B) of Pub. L. 101–239 provided that:
‘‘The amendments made by subparagraph (A) [amending this section] shall apply to—
‘‘(i) qualifying events occurring after December 31,
1989, and
‘‘(ii) in the case of qualified beneficiaries who elected continuation coverage after December 31, 1988, the
period for which the required premium was paid (or
was attempted to be paid but was rejected as such).’’
Section 6801(b)(3)(B) of Pub. L. 101–239 provided that:
‘‘The amendment made by subparagraph (A) [amending
this section] shall apply to plan years beginning after
December 31, 1989.’’
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–514 effective, except as
otherwise provided, as if included in enactment of the
Consolidated Omnibus Budget Reconciliation Act of
1985, Pub. L. 99–272, see section 1895(e) of Pub. L. 99–514,
set out as a note under section 162 of Title 26, Internal
Revenue Code.
PLAN AMENDMENTS NOT REQUIRED UNTIL
JANUARY 1, 1989
For provisions directing that if any amendments
made by subtitle A or subtitle C of title XI [§§ 1101–1147
and 1171–1177] or title XVIII [§§ 1800–1899A] of Pub. L.
99–514 require an amendment to any plan, such plan
amendment shall not be required to be made before the
first plan year beginning on or after Jan. 1, 1989, see
section 1140 of Pub. L. 99–514, as amended, set out as a
note under section 401 of Title 26, Internal Revenue
Code.

§ 300bb–3. Qualifying event
For purposes of this subchapter, the term
‘‘qualifying event’’ means, with respect to any
covered employee, any of the following events
which, but for the continuation coverage required under this subchapter, would result in
the loss of coverage of a qualified beneficiary:
(1) The death of the covered employee.
(2) The termination (other than by reason of
such employee’s gross misconduct), or reduction of hours, of the covered employee’s employment.
(3) The divorce or legal separation of the
covered employee from the employee’s spouse.
(4) The covered employee becoming entitled
to benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].
(5) A dependent child ceasing to be a dependent child under the generally applicable requirements of the plan.
(July 1, 1944, ch. 373, title XXII, § 2203, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 234.)

Page 1170

REFERENCES IN TEXT
The Social Security Act, referred to in par. (4), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title
XVIII of the Social Security Act is classified generally
to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.

§ 300bb–4. Applicable premium
For purposes of this subchapter—
(1) In general
The term ‘‘applicable premium’’ means, with
respect to any period of continuation coverage
of qualified beneficiaries, the cost to the plan
for such period of the coverage for similarly
situated beneficiaries with respect to whom a
qualifying event has not occurred (without regard to whether such cost is paid by the employer or employee).
(2) Special rule for self-insured plans
To the extent that a plan is a self-insured
plan—
(A) In general
Except as provided in subparagraph (B),
the applicable premium for any period of
continuation coverage of qualified beneficiaries shall be equal to a reasonable estimate of the cost of providing coverage for
such period for similarly situated beneficiaries which—
(i) is determined on an actuarial basis,
and
(ii) takes into account such factors as
the Secretary may prescribe in regulations.
(B) Determination on basis of past cost
If a plan administrator elects to have this
subparagraph apply, the applicable premium
for any period of continuation coverage of
qualified beneficiaries shall be equal to—
(i) the cost to the plan for similarly situated beneficiaries for the same period occurring during the preceding determination period under paragraph (3), adjusted
by
(ii) the percentage increase or decrease
in the implicit price deflator of the gross
national product (calculated by the Department of Commerce and published in
the Survey of Current Business) for the 12month period ending on the last day of the
sixth month of such preceding determination period.
(C) Subparagraph (B) not to apply where significant change
A plan administrator may not elect to
have subparagraph (B) apply in any case in
which there is any significant difference, between the determination period and the preceding determination period, in coverage
under, or in employees covered by, the plan.
The determination under the preceding sentence for any determination period shall be
made at the same time as the determination
under paragraph (3).
(3) Determination period
The determination of any applicable premium shall be made for a period of 12 months

Page 1171

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and shall be made before the beginning of such
period.
(July 1, 1944, ch. 373, title XXII, § 2204, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 234.)
§ 300bb–5. Election
(a) In general
For purposes of this subchapter—
(1) Election period
The term ‘‘election period’’ means the period
which—
(A) begins not later than the date on which
coverage terminates under the plan by reason of a qualifying event,
(B) is of at least 60 days’ duration, and
(C) ends not earlier than 60 days after the
later of—
(i) the date described in subparagraph
(A), or
(ii) in the case of any qualified beneficiary who receives notice under section
300bb–6(4) of this title, the date of such notice.
(2) Effect of election on other beneficiaries
Except as otherwise specified in an election,
any election of continuation coverage by a
qualified beneficiary described in subparagraph (A)(i) or (B) of section 300bb–8(3) of this
title shall be deemed to include an election of
continuation coverage on behalf of any other
qualified beneficiary who would lose coverage
under the plan by reason of the qualifying
event. If there is a choice among types of coverage under the plan, each qualified beneficiary is entitled to make a separate selection
among such types of coverage.
(b) Temporary extension of COBRA election period for certain individuals
(1) In general
In the case of a nonelecting TAA-eligible individual and notwithstanding subsection (a) of
this section, such individual may elect continuation coverage under this subchapter during the 60-day period that begins on the first
day of the month in which the individual becomes a TAA-eligible individual, but only if
such election is made not later than 6 months
after the date of the TAA-related loss of coverage.
(2) Commencement of coverage; no reach-back
Any continuation coverage elected by a
TAA-eligible individual under paragraph (1)
shall commence at the beginning of the 60-day
election period described in such paragraph
and shall not include any period prior to such
60-day election period.
(3) Preexisting conditions
With respect to an individual who elects
continuation coverage pursuant to paragraph
(1), the period—
(A) beginning on the date of the TAA-related loss of coverage, and
(B) ending on the first day of the 60-day
election period described in paragraph (1),
shall be disregarded for purposes of determining the 63-day periods referred to in section

§ 300bb–5

2701(c)(2),1 section 1181(c)(2) of title 29, and section 9801(c)(2) of title 26.
(4) Definitions
For purposes of this subsection:
(A) Nonelecting TAA-eligible individual
The term ‘‘nonelecting TAA-eligible individual’’ means a TAA-eligible individual
who—
(i) has a TAA-related loss of coverage;
and
(ii) did not elect continuation coverage
under this part 2 during the TAA-related
election period.
(B) TAA-eligible individual
The
term
‘‘TAA-eligible
individual’’
means—
(i) an eligible TAA recipient (as defined
in paragraph (2) of section 35(c) of title 26),
and
(ii) an eligible alternative TAA recipient
(as defined in paragraph (3) of such section).
(C) TAA-related election period
The term ‘‘TAA-related election period’’
means, with respect to a TAA-related loss of
coverage, the 60-day election period under
this part 2 which is a direct consequence of
such loss.
(D) TAA-related loss of coverage
The term ‘‘TAA-related loss of coverage’’
means, with respect to an individual whose
separation from employment gives rise to
being an TAA-eligible individual, the loss of
health benefits coverage associated with
such separation.
(July 1, 1944, ch. 373, title XXII, § 2205, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 235; amended Pub. L. 99–514, title XVIII,
§ 1895(d)(5)(C), Oct. 22, 1986, 100 Stat. 2939; Pub. L.
107–210, div. A, title II, § 203(e)(2), Aug. 6, 2002, 116
Stat. 970.)
REFERENCES IN TEXT
Section 2701, referred to in subsec. (b)(3), is a reference to section 2701 of act July 1, 1944. Section 2701,
which was classified to section 300gg of this title, was
renumbered section 2704, effective for plan years beginning on or after Jan. 1, 2014, with certain exceptions,
and amended, by Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1), formerly § 1562(c)(1), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 154, 264, 911, and was transferred to
section 300gg–3 of this title. A new section 2701 of act
July 1, 1944, related to fair health insurance premiums,
was added, effective for plan years beginning on or
after Jan. 1, 2014, and amended, by Pub. L. 111–148, title
I, § 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
AMENDMENTS
2002—Pub. L. 107–210 designated existing provisions as
subsec. (a), inserted subsec. heading, and added subsec.
(b).
1986—Par. (2). Pub. L. 99–514 inserted ‘‘of continuation
coverage’’ after ‘‘any election’’ and inserted at end ‘‘If
there is a choice among types of coverage under the
plan, each qualified beneficiary is entitled to make a
separate selection among such types of coverage.’’.
1 See
2 So

References in Text note below.
in original. This subchapter is not divided into parts.

§ 300bb–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107–210 applicable to petitions
for certification filed under part 2 or 3 of subchapter II
of chapter 12 of Title 19, Customs Duties, on or after
the date that is 90 days after Aug. 6, 2002, except as
otherwise provided, see section 151 of Pub. L. 107–210,
set out as a note preceding section 2271 of Title 19.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–514 effective, except as
otherwise provided, as if included in enactment of the
Consolidated Omnibus Budget Reconciliation Act of
1985, Pub. L. 99–272, see section 1895(e) of Pub. L. 99–514,
set out as a note under section 162 of Title 26, Internal
Revenue Code.
CONSTRUCTION OF 2002 AMENDMENT
Nothing in amendment by Pub. L. 107–210, other than
provisions relating to COBRA continuation coverage
and reporting requirements, to be construed as creating
new mandate on any party regarding health insurance
coverage, see section 203(f) of Pub. L. 107–210, set out as
a note under section 2918 of Title 29, Labor.
PLAN AMENDMENTS NOT REQUIRED UNTIL
JANUARY 1, 1989
For provisions directing that if any amendments
made by subtitle A or subtitle C of title XI [§§ 1101–1147
and 1171–1177] or title XVIII [§§ 1800–1899A] of Pub. L.
99–514 require an amendment to any plan, such plan
amendment shall not be required to be made before the
first plan year beginning on or after Jan. 1, 1989, see
section 1140 of Pub. L. 99–514, as amended, set out as a
note under section 401 of Title 26, Internal Revenue
Code.

§ 300bb–6. Notice requirements
In accordance with regulations prescribed by
the Secretary—
(1) the group health plan shall provide, at
the time of commencement of coverage under
the plan, written notice to each covered employee and spouse of the employee (if any) of
the rights provided under this subsection,1
(2) the employer of an employee under a plan
must notify the plan administrator of a qualifying event described in paragraph (1), (2), or
(4) of section 300bb–3 of this title within 30
days of the date of the qualifying event,
(3) each covered employee or qualified beneficiary is responsible for notifying the plan administrator of the occurrence of any qualifying event described in paragraph (3) or (5) of
section 300bb–3 of this title within 60 days
after the date of the qualifying event and each
qualified beneficiary who is determined, under
title II or XVI of the Social Security Act [42
U.S.C. 401 et seq., 1381 et seq.], to have been
disabled at any time during the first 60 days of
continuation coverage under this subchapter
is responsible for notifying the plan administrator of such determination within 60 days
after the date of the determination and for notifying the plan administrator within 30 days
after the date of any final determination
under such title or titles that the qualified
beneficiary is no longer disabled, and
(4) the plan administrator shall notify—
(A) in the case of a qualifying event described in paragraph (1), (2), or (4) of section
300bb–3 of this title, any qualified beneficiary with respect to such event, and
1 So

in original. Probably should be ‘‘subchapter’’.

Page 1172

(B) in the case of a qualifying event described in paragraph (3) or (5) of section
300bb–3 of this title where the covered employee notifies the plan administrator under
paragraph (3), any qualified beneficiary with
respect to such event,
of such beneficiary’s rights under this subsection.1
For purposes of paragraph (4), any notification
shall be made within 14 days of the date on
which the plan administrator is notified under
paragraph (2) or (3), whichever is applicable, and
any such notification to an individual who is a
qualified beneficiary as the spouse of the covered employee shall be treated as notification to
all other qualified beneficiaries residing with
such spouse at the time such notification is
made.
(July 1, 1944, ch. 373, title XXII, § 2206, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 235; amended Pub. L. 99–514, title XVIII,
§ 1895(d)(6)(C), Oct. 22, 1986, 100 Stat. 2939; Pub. L.
100–203, title IV, § 4009(j)(8), Dec. 22, 1987, 101
Stat. 1330–59; Pub. L. 101–239, title VI, § 6702(c),
Dec. 19, 1989, 103 Stat. 2295; Pub. L. 104–191, title
IV, § 421(a)(2), Aug. 21, 1996, 110 Stat. 2088.)
REFERENCES IN TEXT
The Social Security Act, referred to in par. (3), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles II
and XVI of the Social Security Act are classified generally to subchapters II (§ 401 et seq.) and XVI (§ 1381 et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.
AMENDMENTS
1996—Par. (3). Pub. L. 104–191 substituted ‘‘at any
time during the first 60 days of continuation coverage
under this subchapter’’ for ‘‘at the time of a qualifying
event described in section 300bb–3(2) of this title’’.
1989—Par. (3). Pub. L. 101–239 inserted ‘‘and each
qualified beneficiary who is determined, under title II
or XVI of the Social Security Act, to have been disabled at the time of a qualifying event described in section 300bb–3(2) of this title is responsible for notifying
the plan administrator of such determination within 60
days after the date of the determination and for notifying the plan administrator within 30 days after the date
of any final determination under such title or titles
that the qualified beneficiary is no longer disabled’’
after ‘‘date of the qualifying event’’.
1987—Par. (3). Pub. L. 100–203 amended directory language of Pub. L. 99–514, see 1986 Amendment note
below.
1986—Par. (3). Pub. L. 99–514, as amended by Pub. L.
100–203, inserted ‘‘within 60 days after the date of the
qualifying event’’.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–191 effective Jan. 1, 1997,
regardless of whether the qualifying event occurred before, on, or after such date, see section 421(d) of Pub. L.
104–191, set out as a note under section 4980B of Title 26,
Internal Revenue Code.
EFFECTIVE DATE OF 1989 AMENDMENT
Amendment by Pub. L. 101–239 applicable to plan
years beginning on or after Dec. 19, 1989, regardless of
whether the qualifying event occurred before, on, or
after such date, see section 6702(d) of Pub. L. 101–239,
set out as a note under section 300bb–2 of this title.

Page 1173

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 1987 AMENDMENT
Section 4009(j)(8) of Pub. L. 100–203 provided that the
amendment made by that section is effective as if included in Pub. L. 99–514.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by Pub. L. 99–514 applicable only with respect to qualifying events occurring after Oct. 22, 1986,
see section 1895(d)(6)(D) of Pub. L. 99–514, set out as a
note under section 162 of Title 26, Internal Revenue
Code.
NOTIFICATION TO COVERED EMPLOYEES
Section 10003(c) of Pub. L. 99–272 provided that: ‘‘At
the time that the amendments made by this section
[enacting this subchapter] apply to a group health plan
(covered under section 2201 of the Public Health Service
Act [section 300bb–1 of this title]), the plan shall notify
each covered employee, and spouse of the employee (if
any), who is covered under the plan at that time of the
continuation coverage required under title XXII of such
Act [this subchapter]. The notice furnished under this
subsection is in lieu of notice that may otherwise be required under section 2206(1) of such Act [par. (1) of this
section] with respect to such individuals.’’

§ 300bb–7. Enforcement
Any individual who is aggrieved by the failure
of a State, political subdivision, or agency or instrumentality thereof, to comply with the requirements of this subchapter may bring an action for appropriate equitable relief.
(July 1, 1944, ch. 373, title XXII, § 2207, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 236.)
CONTINUED COVERAGE OF COSTS OF PEDIATRIC VACCINE
UNDER CERTAIN GROUP HEALTH PLANS
Pub. L. 103–66, title XIII, § 13631(d), Aug. 10, 1993, 107
Stat. 643, provided that:
‘‘(1) REQUIREMENT.—The requirement of this paragraph, with respect to a group health plan for plan
years beginning after the date of the enactment of this
Act [Aug. 10, 1993], is that the group health plan not reduce its coverage of the costs of pediatric vaccines (as
defined under section 1928(h)(6) of the Social Security
Act [section 1396s(h)(6) of this title]) below the coverage it provided as of May 1, 1993.
‘‘(2) ENFORCEMENT.—For purposes of section 2207 of
the Public Health Service Act [this section], the requirement of paragraph (1) is deemed a requirement of
title XXII of such Act [this subchapter].’’

§ 300bb–8. Definitions
For purposes of this subchapter—
(1) Group health plan
The term ‘‘group health plan’’ has the meaning given such term in 5000(b) 1 of title 26. Such
term shall not include any plan substantially
all of the coverage under which is for qualified
long-term care services (as defined in section
7702B(c) of title 26).
(2) Covered employee
The term ‘‘covered employee’’ means an individual who is (or was) provided coverage
under a group health plan by virtue of the performance of services by the individual for 1 or
more persons maintaining the plan (including
as an employee defined in section 401(c)(1) of
title 26).
1 So

in original. Probably should be preceded by ‘‘section’’.

§ 300bb–8

(3) Qualified beneficiary
(A) In general
The term ‘‘qualified beneficiary’’ means,
with respect to a covered employee under a
group health plan, any other individual who,
on the day before the qualifying event for
that employee, is a beneficiary under the
plan—
(i) as the spouse of the covered employee, or
(ii) as the dependent child of the employee.
Such term shall also include a child who is
born to or placed for adoption with the covered employee during the period of continuation coverage under this subchapter.
(B) Special rule for terminations and reduced employment
In the case of a qualifying event described
in section 300bb–3(2) of this title, the term
‘‘qualified beneficiary’’ includes the covered
employee.
(4) Plan administrator
The term ‘‘plan administrator’’ has the
meaning given the term ‘‘administrator’’ by
section 1002(16)(A) of title 29.
(July 1, 1944, ch. 373, title XXII, § 2208, as added
Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100
Stat. 236; amended Pub. L. 100–647, title III,
§ 3011(b)(7), Nov. 10, 1988, 102 Stat. 3625; Pub. L.
101–239, title VI, § 6801(c)(1), Dec. 19, 1989, 103
Stat. 2297; Pub. L. 104–191, title I, § 102(d), title
III, § 321(d)(3), title IV, § 421(a)(3), Aug. 21, 1996,
110 Stat. 1978, 2059, 2088.)
AMENDMENTS
1996—Par. (1). Pub. L. 104–191, § 321(d)(3), inserted at
end ‘‘Such term shall not include any plan substantially all of the coverage under which is for qualified
long-term care services (as defined in section 7702B(c)
of title 26).’’
Pub. L. 104–191, § 102(d), substituted ‘‘5000(b)’’ for ‘‘section 162(i)(2)’’.
Par. (3)(A). Pub. L. 104–191, § 421(a)(3), inserted at end
‘‘Such term shall also include a child who is born to or
placed for adoption with the covered employee during
the period of continuation coverage under this subchapter.’’
1989—Par. (2). Pub. L. 101–239 substituted ‘‘the performance of services by the individual for 1 or more
persons maintaining the plan (including as an employee defined in section 401(c)(1) of title 26)’’ for ‘‘the
individual’s employment or previous employment with
an employer’’.
1988—Par. (1). Pub. L. 100–647 substituted ‘‘section
162(i)(2) of the Internal Revenue Code of 1986’’ for ‘‘section 162(i)(3) of the Internal Revenue Code of 1954’’,
which for purposes of codification was translated as
‘‘section 162(i)(2) of title 26’’.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by section 321(d)(3) of Pub. L. 104–191 applicable to contracts issued after Dec. 31, 1996, see section 321(f) of Pub. L. 104–191, set out as an Effective
Date note under section 7702B of Title 26, Internal Revenue Code.
Amendment by section 421(a)(3) of Pub. L. 104–191 effective Jan. 1, 1997, regardless of whether the qualifying
event occurred before, on, or after such date, see section 421(d) of Pub. L. 104–191, set out as a note under
section 4980B of Title 26.
EFFECTIVE DATE OF 1989 AMENDMENT
Section 6801(c)(2) of Pub. L. 101–239 provided that:
‘‘The amendment made by paragraph (1) [amending this

§ 300cc

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section] shall apply to plan years beginning after December 31, 1989.’’
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–647 applicable to taxable
years beginning after Dec. 31, 1988, but not applicable
to any plan for any plan year to which section 162(k) of
Title 26, Internal Revenue Code (as in effect on the day
before Nov. 10, 1988), did not apply by reason of section
10001(e)(2) of Pub. L. 99–272, see section 3011(d) of Pub.
L. 100–647, set out as a note under section 162 of Title
26.

SUBCHAPTER XXI—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME
PRIOR PROVISIONS
A prior subchapter XXI (§ 300cc et seq.), comprised of
title XXIII of the Public Health Service Act, act July
1, 1944, ch. 373, 2301–2316, was renumbered title XXV,
§§ 2501–2514, of the Public Health Service Act, and transferred to subchapter XXV (§ 300aaa et seq.) of this chapter, renumbered title XXVI, §§ 2601–2614, of the Public
Health
Service
Act,
renumbered
title
XXVII,
§§ 2701–2714, of the Public Health Service Act, and renumbered title II, part B, §§ 231–244, of the Public
Health Service Act, and transferred to part B (§ 238 et
seq.) of subchapter I of this chapter.

PART A—ADMINISTRATION OF RESEARCH
PROGRAMS
§ 300cc. Repealed. Pub. L. 109–482, title
§ 104(b)(2)(C), Jan. 15, 2007, 120 Stat. 3693

I,

Section, act July 1, 1944, ch. 373, title XXIII, § 2301, as
added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3063; amended Pub. L. 102–531, title III, § 312(d)(16),
Oct. 27, 1992, 106 Stat. 3505, required an annual comprehensive report on all expenditures by Secretary with
respect to AIDS.
A prior section 300cc, act July 1, 1944, § 2301, was successively renumbered by subsequent acts and transferred, see section 238 of this title.
EFFECTIVE DATE OF REPEAL
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109–482, set out as an
Effective Date of 2007 Amendment note under section
281 of this title.

§ 300cc–1. Requirement of expediting awards of
grants and contracts for research
(a) In general
The Secretary shall expedite the award of
grants, contracts, and cooperative agreements
for research projects relating to acquired immune deficiency syndrome (including such research projects initiated independently of any
solicitation by the Secretary for proposals for
such research projects).
(b) Time limitations with respect to certain applications
(1) With respect to programs of grants, contracts, and cooperative agreements described in
subsection (a) of this section, any application
submitted in response to a solicitation by the
Secretary for proposals pursuant to such a program—
(A) may not be approved if the application is
submitted after the expiration of the 3-month
period beginning on the date on which the solicitation is issued; and

Page 1174

(B) shall be awarded, or otherwise finally
acted upon, not later than the expiration of
the 6-month period beginning on the expiration of the period described in subparagraph
(A).
(2) If the Secretary makes a determination
that it is not practicable to administer a program referred to in paragraph (1) in accordance
with the time limitations described in such
paragraph, the Secretary may adjust the time
limitations accordingly.
(c) Requirements with respect to adjustments in
time limitations
With respect to any program for which a determination described in subsection (b)(2) of this
section is made, the Secretary shall—
(1) if the determination is made before the
Secretary issues a solicitation for proposals
pursuant to the program, ensure that the solicitation describes the time limitations as adjusted by the determination; and
(2) if the determination is made after the
Secretary issues such a solicitation for proposals, issue a statement describing the time limitations as adjusted by the determination and
individually notify, with respect to the determination, each applicant whose application is
submitted before the expiration of the 3month period beginning on the date on which
the solicitation was issued.
(d) Annual reports to Congress
Except as provided in subsection (e) of this
section, the Secretary shall annually prepare,
for inclusion in the comprehensive report required in section 300cc 1 of this title, a report—
(A) summarizing programs for which the
Secretary has made a determination described
in subsection (b)(2) of this section, including a
description of the time limitations as adjusted
by the determination and including a summary of the solicitation issued by the Secretary for proposals pursuant to the program;
and
(B) summarizing applications that—
(i) were submitted pursuant to a program
of grants, contracts, or cooperative agreements referred to in paragraph (1) of subsection (b) of this section for which a determination described in paragraph (2) of such
subsection has not been made; and
(ii) were not processed in accordance with
the time limitations described in such paragraph (1).
(e) Quarterly reports for fiscal year 1989
For fiscal year 1989, the report required in subsection (d) of this section shall, not less than
quarterly, be prepared and submitted to the
Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate.
(July 1, 1944, ch. 373, title XXIII, § 2302, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3063.)
REFERENCES IN TEXT
Section 300cc of this title, referred to in subsec. (d),
was repealed by Pub. L. 109–482, title I, § 104(b)(2)(C),
Jan. 15, 2007, 120 Stat. 3693.
1 See

References in Text note below.

Page 1175

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior section 300cc–1, act July 1, 1944, § 2302, was
successively renumbered by subsequent acts and transferred, see section 238a of this title.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
DEVELOPMENT OF RAPID HIV TEST
Pub. L. 106–345, title V, § 502, Oct. 20, 2000, 114 Stat.
1353, provided that:
‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINATION
OF RESEARCH AND OTHER ACTIVITIES.—
‘‘(1) IN GENERAL.—The Director of NIH shall expand,
intensify, and coordinate research and other activities of the National Institutes of Health with respect
to the development of reliable and affordable tests for
HIV disease that can rapidly be administered and
whose results can rapidly be obtained (in this section
referred to as ‘rapid HIV test’).
‘‘(2) REPORT TO CONGRESS.—The Director of NIH
shall periodically submit to the appropriate committees of Congress a report describing the research and
other activities conducted or supported under paragraph (1).
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
‘‘(b) PREMARKET REVIEW OF RAPID HIV TESTS.—
‘‘(1) IN GENERAL.—Not later than 90 days after the
date of the enactment of this Act [Oct. 20, 2000], the
Secretary, in consultation with the Director of the
Centers for Disease Control and Prevention and the
Commissioner of Food and Drugs, shall submit to the
appropriate committees of the Congress a report describing the progress made towards, and barriers to,
the premarket review and commercial distribution of
rapid HIV tests. The report shall—
‘‘(A) assess the public health need for and public
health benefits of rapid HIV tests, including the
minimization of false positive results through the
availability of multiple rapid HIV tests;
‘‘(B) make recommendations regarding the need
for the expedited review of rapid HIV test applications submitted to the Center for Biologics Evaluation and Research and, if such recommendations
are favorable, specify criteria and procedures for
such expedited review; and
‘‘(C) specify whether the barriers to the premarket review of rapid HIV tests include the unnecessary application of requirements—
‘‘(i) necessary to ensure the efficacy of devices
for donor screening to rapid HIV tests intended
for use in other screening situations; or
‘‘(ii) for identifying antibodies to HIV subtypes
of rare incidence in the United States to rapid
HIV tests intended for use in screening situations
other than donor screening.
‘‘(c) GUIDELINES OF CENTERS FOR DISEASE CONTROL
AND PREVENTION.—Promptly after commercial distribution of a rapid HIV test begins, the Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall establish or update guidelines

§ 300cc–1

that include recommendations for States, hospitals,
and other appropriate entities regarding the ready
availability of such tests for administration to pregnant women who are in labor or in the late stage of
pregnancy and whose HIV status is not known to the
attending obstetrician.’’
LIMITATION ON EXPENDITURES FOR AIDS AND HIV
ACTIVITIES
Pub. L. 104–146, § 11, May 20, 1996, 110 Stat. 1373, provided that: ‘‘Notwithstanding any other provision of
law, the total amounts of Federal funds expended in
any fiscal year for AIDS and HIV activities may not exceed the total amounts expended in such fiscal year for
activities related to cancer.’’
VACCINES FOR HUMAN IMMUNODEFICIENCY VIRUS
Pub. L. 103–43, title XIX, § 1901(b), June 10, 1993, 107
Stat. 200, provided that:
‘‘(1) IN GENERAL.—The Secretary of Health and
Human Services, acting through the National Institutes of Health, shall develop a plan for the appropriate
inclusion of HIV-infected women, including pregnant
women, HIV-infected infants, and HIV-infected children
in studies conducted by or through the National Institutes of Health concerning the safety and efficacy of
HIV vaccines for the treatment and prevention of HIV
infection. Such plan shall ensure the full participation
of other Federal agencies currently conducting HIV
vaccine studies and require that such studies conform
fully to the requirements of part 46 of title 45, Code of
Federal Regulations.
‘‘(2) REPORT.—Not later than 180 days after the date
of the enactment of this Act [June 10, 1993], the Secretary of Health and Human Services shall prepare and
submit to the Committee on Energy and Commerce of
the House of Representatives, and the Committee on
Labor and Human Resources [now Committee on
Health, Education, Labor, and Pensions] of the Senate,
a report concerning the plan developed under paragraph
(1).
‘‘(3) IMPLEMENTATION.—Not later than 12 months after
the date of the enactment of this Act, the Secretary of
Health and Human Services shall implement the plan
developed under paragraph (1), including measures for
the full participation of other Federal agencies currently conducting HIV vaccine studies.
‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1994 through 1996.’’
EX. ORD. NO. 12963. PRESIDENTIAL ADVISORY COUNCIL ON
HIV/AIDS
Ex. Ord. No. 12963, June 14, 1995, 60 F.R. 31905, as
amended by Ex. Ord. No. 13009, June 14, 1996, 61 F.R.
39799 [30799], provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, I hereby direct the Secretary of Health and
Human Services to exercise her discretion as follows:
SECTION 1. Establishment. (a) The Secretary of Health
and Human Services (the ‘‘Secretary’’) shall establish
an HIV/AIDS Advisory Council (the ‘‘Advisory Council’’
or the ‘‘Council’’), to be known as the Presidential Advisory Council on HIV/AIDS. The Advisory Council
shall be composed of not more than 35 members to be
appointed or designated by the Secretary. The Advisory
Council shall comply with the Federal Advisory Committee Act, as amended (5 U.S.C. App.).
(b) The Secretary shall designate a Chairperson from
among the members of the Advisory Council.
SEC. 2. Functions. The Advisory Council shall provide
advice, information, and recommendations to the Secretary regarding programs and policies intended to (a)
promote effective prevention of HIV disease, (b) advance research on HIV and AIDS, and (c) promote quality services to persons living with HIV disease and
AIDS. The functions of the Advisory Council shall be

§ 300cc–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

solely advisory in nature. The Secretary shall provide
the President with copies of all written reports provided to the Secretary by the Advisory Council.
SEC. 3. Administration. (a) The heads of executive departments and agencies shall, to the extent permitted
by law, provide the Advisory Council with such information as it may require for purposes of carrying out
its functions.
(b) Any members of the Advisory Council that receive
compensation shall be compensated in accordance with
Federal law. Committee members may be allowed travel expenses, including per diem in lieu of subsistence,
to the extent permitted by law for persons serving
intermittently in the Government service (5 U.S.C. section 5701–5707).
(c) To the extent permitted by law, and subject to the
availability of appropriations, the Department of
Health and Human Services shall provide the Advisory
Council with such funds and support as may be necessary for the performance of its functions.
SEC. 4. General Provisions. (a) Notwithstanding the
provisions of any other Executive order, any functions
of the President under the Federal Advisory Committee
Act that are applicable to the Advisory Council, except
that of reporting annually to the Congress, shall be
performed by the Department of Health and Human
Services, in accordance with the guidelines and procedures established by the Administrator of General
Services.
(b) This order is intended only to improve the internal management of the executive branch, and it is not
intended to create any right, benefit, or trust responsibility, substantive or procedural, enforceable at law
or equity by a party against the United States, its
agencies, it officers, or any person.
WILLIAM J. CLINTON.
IMPLEMENTATION OF THE NATIONAL HIV/AIDS STRATEGY
Memorandum of President of the United States, July
13, 2010, 75 F.R. 41687, provided:
Memorandum for the Heads of Executive Departments and Agencies
As we approach 30 years from the onset of the HIV/
AIDS epidemic in the United States, new actions are
needed to prevent HIV infection and better serve people
living with HIV. The actions we take now will build
upon a legacy of global leadership, national commitment, and sustained efforts on the part of Americans
from all parts of the country and all walks of life to
end the HIV epidemic in the United States and around
the world. I am committed to renewing national leadership to fight HIV/AIDS here at home, as we continue
our efforts to fight HIV/AIDS around the world. My Administration has engaged in an extensive process to engage Americans and listen to their ideas for improving
our national response to HIV/AIDS.
Today I am releasing a National HIV/AIDS Strategy
for the United States (Strategy) and a National HIV/
AIDS Strategy Federal Implementation Plan (Federal
Implementation Plan), which identifies specific actions
to be taken by Federal agencies to implement the
Strategy’s goals. While agencies already undertake
many actions to address HIV/AIDS, successful implementation of the Strategy will require new levels of coordination, collaboration, and accountability. This will
require the Federal Government to work in new ways
across agency lines, as well as in enhanced and innovative partnerships with State, tribal, and local governments. Government cooperation at all levels, moreover,
is not enough. Success will require the commitment of
all parts of society, including businesses, faith communities, philanthropic organizations, scientific and medical communities, educational institutions, people living with HIV, and others. It is also necessary to sustain
public commitment to ending the epidemic, and this
calls for regular communications between governments
at all levels to identify the challenges we face and report the progress we are making. To these ends, I hereby direct the following:

Page 1176

SECTION 1. Role of the White House Office of National
AIDS Policy (ONAP).
(a) The Director of the ONAP, in consultation with
the Office of Management and Budget (OMB), shall be
responsible for setting the Administration’s domestic
HIV/AIDS priorities and monitoring the implementation of the Strategy. The Director of the ONAP shall
convene regular meetings with representatives of executive departments and agencies (agencies) to coordinate HIV/AIDS-related policies, programs, and activities.
(b) The Director of the ONAP shall annually report to
the President on the implementation of the Strategy,
including progress in meeting key targets and taking
key actions identified in the Strategy and the Federal
Implementation Plan.
SEC. 2. Lead Responsible Agencies. While the Strategy
requires a Government-wide effort in order to succeed
fully, certain agencies have primary responsibilities
and competencies in implementing the Strategy.
(a) Designation of Lead Agencies. Lead agencies for implementing the Strategy shall be:
(i) the Department of Health and Human Services;
(ii) the Department of Justice;
(iii) the Department of Labor;
(iv) the Department of Housing and Urban Development;
(v) the Department of Veterans Affairs; and
(vi) the Social Security Administration.
(b) Lead Agency Implementation Plans. Within 150 days
of the date of this memorandum, the head of each lead
agency shall submit a report to the ONAP and the OMB
on the agency’s operational plans for implementing the
Strategy. The plans shall assign responsibilities to
agency officials, designate reporting structures for actions identified in the Federal Implementation Plan,
and identify other appropriate actions to advance the
Strategy. The plans shall also include steps to
strengthen coordination in planning, budgeting for, and
evaluating domestic HIV/AIDS programs within and
across agencies. Lead agencies are encouraged to consider, and reflect in their plans, steps to streamline
grantee reporting requirements and funding announcements related to HIV/AIDS programs and activities.
(c) Ongoing Responsibilities of Lead Agencies. The head
of each lead agency shall:
(i) designate an official responsible for coordinating
the agency’s ongoing efforts to implement the Strategy;
(ii) develop a process for sharing progress reports, including status updates on achieving specific quantitative targets established by the Strategy, with relevant agencies and the ONAP on an annual basis, or at
such other times as the ONAP requests; and
(iii) in consultation with the OMB, use the budget development process to prioritize programs and activities
most critical to meeting the goals of the Strategy.
SEC. 3. Role of the Secretary of Health and Human Services. The Secretary of Health and Human Services (Secretary), or the Secretary’s designee, shall be responsible for improving coordination of domestic HIV/AIDS
programs and activities across the Federal Government.
(a) Coordination within the Department of Health and
Human Services. The Secretary, or the Secretary’s designee, shall develop and implement specific plans and
procedures for improving intra-departmental coordination and collaboration on HIV/AIDS care, research, and
prevention services.
(b) Coordination with Other Agencies. The Secretary, or
the Secretary’s designee, shall be responsible for convening interagency efforts to improve coordination of
HIV/AIDS programs and activities. This may include
collaboration with governmental and nongovernmental
entities to achieve the Federal Government’s implementation and research priorities in the areas of highest impact.
(c) Presidential Advisory Council on HIV/AIDS
(PACHA). PACHA, which was established by Executive
Order 12963 of June 14, 1995 (Presidential Advisory

Page 1177

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Council on HIV/AIDS), as amended, shall monitor the
implementation of the Strategy and make recommendations to the Secretary and to the Director of the
ONAP, as appropriate, concerning implementation.
SEC. 4. Responsibilities of Other Agencies. All agencies
that support HIV/AIDS programs and activities shall
ensure that, to the extent permitted by law, they are
meeting the goals of the Strategy.
(a) Department of Defense. Within 150 days of the date
of this memorandum, the Secretary of Defense shall
submit to the ONAP and the OMB a plan for aligning
the health-care services provided by the Department of
Defense with the Strategy, to the extent feasible and
permitted by law. The plan shall address, in particular,
HIV/AIDS prevention, care, and treatment.
(b) Department of State. Within 150 days of the date of
this memorandum, the Secretary of State shall submit
to the ONAP and the OMB recommendations for improving the Government-wide response to the domestic
HIV/AIDS epidemic, based on lessons learned in implementing the President’s Emergency Plan for AIDS Relief (PEPFAR) program.
(c) Equal Employment Opportunity Commission (Commission). Within 150 days of the date of this memorandum,
the Chair of the Commission shall submit to the ONAP
and the OMB recommendations for increasing employment opportunities for people living with HIV and a
plan for addressing employment-related discrimination
against people living with HIV, consistent with the
Commission’s authorities and other applicable law.
SEC. 5. General Provisions.
(a) The heads of executive departments and agencies
shall assist and provide information to the Director of
the ONAP, consistent with applicable law, as may be
necessary to implement the Strategy. Each agency
shall bear its own expense for carrying out activities to
implement the Strategy.
(b) Nothing in this memorandum shall be construed
to impair or otherwise affect:
(i) authority granted by law to a department or agency or the head thereof, or to other executive branch officials; or
(ii) functions of the Director of the OMB relating to
budgetary, administrative, or legislative proposals.
(c) This memorandum shall be implemented consistent with applicable law and subject to the availability
of appropriations.
(d) This memorandum is not intended to, and does
not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party
against the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any other
person.
SEC. 6. Publication. The Secretary is authorized and
directed to publish this memorandum in the Federal
Register.
BARACK OBAMA.

§ 300cc–2. Requirements with respect to processing of requests for personnel and administrative support
(a) In general
The Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, shall respond to any
priority request made by the Administrator of
the Substance Abuse and Mental Health Services Administration, the Director of the Centers
for Disease Control and Prevention, the Commissioner of Food and Drugs, or the Director of
the National Institutes of Health, not later than
21 days after the date on which such request is
made. If the Director of the Office of Personnel
Management or the Administrator of General
Services, as the case may be, does not disapprove a priority request during the 21-day period, the request shall be deemed to be approved.

§ 300cc–2

(b) Notice to Secretary and to Assistant Secretary for Health
The Administrator of the Substance Abuse and
Mental Health Services Administration, the Director of the Centers for Disease Control and
Prevention, the Commissioner of Food and
Drugs, and the Director of the National Institutes of Health, shall, respectively, transmit to
the Secretary and the Assistant Secretary for
Health a copy of each priority request made
under this section by the agency head involved.
The copy shall be transmitted on the date on
which the priority request involved is made.
(c) ‘‘Priority request’’ defined
For purposes of this section, the term ‘‘priority request’’ means any request that—
(1) is designated as a priority request by the
Administrator of the Substance Abuse and
Mental Health Services Administration, the
Director of the Centers for Disease Control
and Prevention, the Commissioner of Food and
Drugs, or the Director of the National Institutes of Health; and
(2)(A) is made to the Director of the Office of
Personnel Management for the allocation of
personnel to carry out activities with respect
to acquired immune deficiency syndrome; or
(B) is made to the Administrator of General
Services for administrative support or space in
carrying out such activities.
(July 1, 1944, ch. 373, title XXIII, § 2303, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3064; amended Pub. L. 102–321, title I, §§ 161,
163(b)(7), July 10, 1992, 106 Stat. 375, 376; Pub. L.
102–531, title III, § 312(d)(17), Oct. 27, 1992, 106
Stat. 3505.)
PRIOR PROVISIONS
A prior section 300cc–2, act July 1, 1944, § 2303, was
successively renumbered by subsequent acts and transferred, see section 238b of this title.
AMENDMENTS
1992—Subsec. (a). Pub. L. 102–531 substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’.
Pub. L. 102–321, § 161, substituted ‘‘Administrator of
the Substance Abuse and Mental Health Services Administration’’ for ‘‘Administrator of the Alcohol, Drug
Abuse, and Mental Health Administration’’.
Subsec. (b). Pub. L. 102–531 substituted ‘‘Centers for
Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–321, § 163(b)(7)(A), substituted ‘‘Administrator of the Substance Abuse and Mental Health Services Administration’’ for ‘‘Administrator of the Alcohol, Drug Abuse, and Mental Health Administration’’.
Subsec. (c)(1). Pub. L. 102–531 substituted ‘‘Centers for
Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
Pub. L. 102–321, § 163(b)(7)(B), substituted ‘‘Administrator of the Substance Abuse and Mental Health Services Administration’’ for ‘‘Administrator of the Alcohol, Drug Abuse, and Mental Health Administration’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
see section 801(c) of Pub. L. 102–321, set out as a note
under section 236 of this title.

§ 300cc–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300cc–3. Establishment of Research Advisory
Committee
(a) In general
After consultation with the Commissioner of
Food and Drugs, the Secretary, acting through
the Director of the National Institute of Allergy
and Infectious Diseases, shall establish within
such Institute an advisory committee to be
known as the AIDS Research Advisory Committee (hereafter in this section referred to as the
‘‘Committee’’).
(b) Composition
The Committee shall be composed of physicians whose clinical practice includes a significant number of patients with acquired immune
deficiency syndrome.
(c) Duties
The Committee shall—
(1) advise the Director of such Institute (and
may provide advice to the Directors of other
agencies of the National Institutes of Health,
as appropriate) on appropriate research activities to be undertaken with respect to clinical
treatment of such syndrome, including advice
with respect to—
(A) research on drugs for preventing or
minimizing the development of symptoms or
conditions arising from infection with the
etiologic agent for such syndrome, including
recommendations on the projects of research
with respect to diagnosing immune deficiency and with respect to predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and
(B) research on the effectiveness of treating such symptoms or conditions with drugs
that—
(i) are not approved by the Commissioner of Food and Drugs for the purpose of
treating such symptoms or conditions; and
(ii) are being utilized for such purpose by
individuals infected with such etiologic
agent;
(2)(A) review ongoing publicly and privately
supported research on clinical treatment for
acquired immune deficiency syndrome, including research on drugs described in paragraph
(1); and
(B) periodically issue, and make available to
health care professionals, reports describing
and evaluating such research;
(3) conduct studies and convene meetings for
the purpose of determining the recommendations among physicians in clinical practice on
clinical treatment of acquired immune deficiency syndrome, including treatment with
the drugs described in paragraph (1); and
(4) conduct a study for the purpose of developing, with respect to individuals infected
with the etiologic agent for acquired immune
deficiency syndrome, a consensus among
health care professionals on clinical treatments for preventing or minimizing the development of symptoms or conditions arising
from infection with such etiologic agent.
(July 1, 1944, ch. 373, title XXIII, § 2304, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3065; amended Pub. L. 100–690, title II,

Page 1178

§ 2617(a), Nov. 18, 1988, 102 Stat. 4240; Pub. L.
103–43, title XVIII, § 1811(1), title XX, § 2008(d)(1),
June 10, 1993, 107 Stat. 199, 212.)
PRIOR PROVISIONS
A prior section 300cc–3, acts July 1, 1944, ch. 373, title
XXIII, § 2304, formerly title V, § 504, 58 Stat. 710; June
25, 1948, ch. 654, § 6, 62 Stat. 1018; 1953 Reorg. Plan No.
1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; renumbered title XXI, § 2104, Apr. 26, 1983, Pub. L. 98–24,
§ 2(a)(1), 97 Stat. 176; renumbered title XXIII, § 2304,
Nov. 14, 1986, Pub. L. 99–660, title III, § 311(a), 100 Stat.
3755, related to care of Service patients at Saint Elizabeths Hospital, prior to repeal by Pub. L. 98–621, § 10(s),
Nov. 8, 1984, 98 Stat. 3381, effective Oct. 1, 1987. Subsequent to repeal, section 2104 of title XXI of act July 1,
1944, was renumbered section 2304 of title XXIII of that
act by section 311(a) of Pub. L. 99–660.
A prior section 300cc–4, acts July 1, 1944, ch. 373, title
XXI, § 2105, formerly title V, § 505, 58 Stat. 710; 1953
Reorg. Plan No. 1, §§ 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; renumbered title XXI, § 2105, Apr. 26, 1983,
Pub. L. 98–24, § 2(a)(1), 97 Stat. 176, provided procedures
under which the Secretary could settle claims for damages from collisions or incident to the operation of vessels within a year of the accrual of such claims and not
to exceed $3,000, prior to repeal by Pub. L. 99–117, § 12(f),
Oct. 7, 1985, 99 Stat. 495. Subsequent to repeal, section
2105 of title XXI of act July 1, 1944, was renumbered section 2305 of title XXIII of that act by Pub. L. 99–660,
title III, § 311(a), Nov. 14, 1986, 100 Stat. 3755.
Prior sections 300cc–5 to 300cc–10, act July 1, 1944,
§§ 2306 to 2311, respectively, were successively renumbered by subsequent acts and transferred, see sections
238c to 238h of this title.
AMENDMENTS
1993—Pub. L. 103–43, § 2008(d)(1)(A), substituted ‘‘Research Advisory Committee’’ for ‘‘Clinical Research
Review Committee’’ in section catchline.
Subsec. (a). Pub. L. 103–43, § 2008(d)(1)(B), substituted
‘‘AIDS Research Advisory Committee’’ for ‘‘AIDS Clinical Research Review Committee’’.
Subsec. (c)(1). Pub. L. 103–43, § 1811(1), in introductory
provisions inserted ‘‘(and may provide advice to the Directors of other agencies of the National Institutes of
Health, as appropriate)’’ after ‘‘Director of such Institute’’ and in subpar. (A) inserted before semicolon at
end ‘‘, including recommendations on the projects of
research with respect to diagnosing immune deficiency
and with respect to predicting, diagnosing, preventing,
and treating opportunistic cancers and infectious diseases’’.
1988—Subsec. (c)(2)(B). Pub. L. 100–690 substituted
semicolon for period.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as

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may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

PART B—RESEARCH AUTHORITY
§ 300cc–11. Clinical evaluation units at National
Institutes of Health
(a) In general
The Secretary, acting through the Director of
the National Cancer Institute and the Director
of the National Institute of Allergy and Infectious Diseases, shall for each such Institute establish a clinical evaluation unit at the Clinical
Center at the National Institutes of Health.
Each of the clinical evaluation units—
(1) shall conduct clinical evaluations of
experimental treatments for acquired immune
deficiency syndrome developed within the preclinical drug development program, including
evaluations of methods of diagnosing immune
deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating
opportunistic cancers and infectious diseases;
and
(2) may conduct clinical evaluations of
experimental treatments for such syndrome
that are developed by any other national research institute of the National Institutes of
Health or by any other entity.
(b) Personnel and administrative support
(1) For the purposes described in subsection (a)
of this section, the Secretary, acting through
the Director of the National Institutes of
Health, shall provide each of the clinical evaluation units required in such subsection—
(A)(i) with not less than 50 beds; or
(ii) with an outpatient clinical capacity
equal to not less than twice the outpatient
clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the
Clinical Center of the National Institutes of
Health on June 1, 1988; and
(B) with such personnel, such administrative
support, and such other support services as
may be necessary.
(2) Facilities, personnel, administrative support, and other support services provided pursuant to paragraph (1) shall be in addition to the
number or level of facilities, personnel, administrative support, and other support services that
otherwise would be available at the Clinical
Center at the National Institutes of Health for
the provision of clinical care for individuals
with diseases or disorders.
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2311, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3066; amended Pub. L. 103–43, title XVIII,
§ 1811(2), June 10, 1993,107 Stat. 199.)
PRIOR PROVISIONS
A prior section 300cc–11, act July 1, 1944, § 2312, was
successively renumbered by subsequent acts and transferred, see section 238i of this title.
AMENDMENTS
1993—Subsec. (a)(1). Pub. L. 103–43 inserted before
semicolon at end ‘‘, including evaluations of methods

§ 300cc–12

of diagnosing immune deficiency and evaluations of
methods of predicting, diagnosing, preventing, and
treating opportunistic cancers and infectious diseases’’.

§ 300cc–12. Use of investigational new drugs with
respect to acquired immune deficiency syndrome
(a) Encouragement of applications with respect
to clinical trials
(1) If, in the determination of the Secretary,
there is preliminary evidence that a new drug
has effectiveness in humans with respect to the
prevention or treatment of acquired immune deficiency syndrome, the Secretary shall, through
statements published in the Federal Register—
(A) announce the fact of such determination;
and
(B) with respect to the new drug involved,
encourage an application for an exemption for
investigational use of the new drug under regulations issued under section 355(i) of title 21.
(2)(A) The AIDS Research Advisory Committee
established pursuant to section 300cc–3 of this
title shall make recommendations to the Secretary with respect to new drugs appropriate for
determinations described in paragraph (1).
(B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A).
(b) Encouragement of applications with respect
to treatment use in circumstances other than
clinical trials
(1) In the case of a new drug with respect to
which the Secretary has made a determination
described in subsection (a) of this section and
with respect to which an exemption is in effect
for purposes of section 355(i) of title 21, the Secretary shall—
(A) as appropriate, encourage the sponsor of
the investigation of the new drug to submit to
the Secretary, in accordance with regulations
issued under such section, an application to
use the drug in the treatment of individuals—
(i) who are infected with the etiologic
agent for acquired immune deficiency syndrome; and
(ii) who are not participating in the clinical trials conducted pursuant to such exemption; and
(B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in accordance with such
regulations, the new drug from such sponsor
for the purpose of treating such individuals.
(2) If the sponsor of the investigation of a new
drug described in paragraph (1) does not submit
to the Secretary an application described in
such paragraph (relating to treatment use), the
Secretary shall, through statements published
in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit
to the Secretary such applications in accordance
with regulations described in such paragraph.
(c) Technical assistance with respect to treatment use
In the case of a new drug with respect to
which the Secretary has made a determination

§ 300cc–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

described in subsection (a) of this section, the
Secretary may, directly or through grants or
contracts, provide technical assistance with respect to the process of—
(1) submitting to the Secretary applications
for exemptions described in paragraph (1)(B) of
such subsection;
(2) submitting to the Secretary applications
described in subsection (b) of this section; and
(3) with respect to sponsors of investigations
of new drugs, facilitating the transfer of new
drugs from such sponsors to licensed medical
practitioners.
(d) ‘‘New drug’’ defined
For purposes of this section, the term ‘‘new
drug’’ has the meaning given such term in section 321 of title 21.
(July 1, 1944, ch. 373, title XXIII, § 2312, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3066; amended Pub. L. 103–43, title XX,
§ 2008(d)(2), June 10, 1993, 107 Stat. 212.)
PRIOR PROVISIONS
A prior section 300cc–12, act July 1, 1944, § 2313, was
successively renumbered by subsequent acts and transferred, see section 238j of this title.
AMENDMENTS
1993—Subsec. (a)(2)(A). Pub. L. 103–43 substituted
‘‘AIDS Research Advisory Committee’’ for ‘‘AIDS Clinical Research Review Committee’’.

§ 300cc–13. Terry Beirn Community-Based AIDS
Research Initiative
(a) In general
After consultation with the Commissioner of
Food and Drugs, the Director of the National Institutes of Health, acting through the Director
of the National Institute of Allergy and Infectious Diseases, may make grants to public entities and nonprofit private entities concerned
with acquired immune deficiency syndrome, and
may enter into contracts with public and private such 1 entities, for the purpose of planning
and conducting, in the community involved,
clinical trials of experimental treatments for infection with the etiologic agent for such syndrome that are approved by the Commissioner of
Food and Drugs for investigational use under
regulations issued under section 355 of title 21.
(b) Requirement of certain projects
(1) Financial assistance under subsection (a) of
this section shall include such assistance to
community-based organizations and community
health centers for the purpose of—
(A) retaining appropriate medical supervision;
(B) assisting with administration, data collection and record management; and
(C) conducting training of community physicians, nurse practitioners, physicians’ assistants and other health professionals for the
purpose of conducting clinical trials.
(2)(A) Financial assistance under subsection
(a) of this section shall include such assistance
for demonstration projects designed to implement and conduct community-based clinical
1 So

in original.

Page 1180

trials in order to provide access to the entire
scope of communities affected by infections
with the etiologic agent for acquired immune
deficiency syndrome, including minorities, hemophiliacs and transfusion-exposed individuals,
women, children, users of intravenous drugs, and
individuals who are asymptomatic with respect
to such infection.
(B) The Director of the National Institutes of
Health may not provide financial assistance
under this paragraph unless the application for
such assistance is approved—
(i) by the Commissioner of Food and Drugs;
(ii) by a duly constituted Institutional Review Board that meets the requirements of
part 56 of title 21, Code of Federal Regulations;
and
(iii) by the Director of the National Institute of Allergy and Infectious Diseases.
(c) Participation of private industry, schools of
medicine and primary providers
Programs carried out with financial assistance
provided under subsection (a) of this section
shall be designed to encourage private industry
and schools of medicine, osteopathic medicine,
and existing consortia of primary care providers
organized to conduct clinical research concerning acquired immune deficiency syndrome to
participate in, and to support, the clinical trials
conducted pursuant to the programs.
(d) Requirement of application
The Secretary may not provide financial assistance under subsection (a) of this section unless—
(1) an application for the assistance is submitted to the Secretary;
(2) with respect to carrying out the purpose
for which the assistance is to be made, the application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this section.
(e) Authorization of appropriations
(1) For the purpose of carrying out subsection
(b)(1) of this section, there are authorized to be
appropriated such sums as may be necessary for
each of the fiscal years 1989 through 1996.
(2) For the purpose of carrying out subsection
(b)(2) of this section, there are authorized to be
appropriated such sums as may be necessary for
each of the fiscal years 1989 through 1996.
(July 1, 1944, ch. 373, title XXIII, § 2313, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3068; amended Pub. L. 100–690, title II,
§ 2617(b), Nov. 18, 1988, 102 Stat. 4240; Pub. L.
101–93, § 6, Aug. 16, 1989, 103 Stat. 615; Pub. L.
102–96, § 3, Aug. 14, 1991, 105 Stat. 481.)
PRIOR PROVISIONS
A prior section 300cc–13, act July 1, 1944, § 2314, was
successively renumbered by subsequent acts and transferred, see section 238k of this title.
AMENDMENTS
1991—Pub. L. 102–96, § 3(1), substituted ‘‘Terry Beirn
Community-Based AIDS Research Initiative’’ for

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‘‘Community-based evaluations of experimental therapies’’ in section catchline.
Subsec. (c). Pub. L. 102–96, § 3(2), substituted
‘‘, schools of medicine and primary providers’’ for ‘‘and
schools of medicine’’ in heading and substituted
‘‘schools of medicine, osteopathic medicine, and existing consortia of primary care providers organized to
conduct clinical research concerning acquired immune
deficiency syndrome’’ for ‘‘schools of medicine and osteopathic medicine’’.
Subsec. (e). Pub. L. 102–96, § 3(3), substituted ‘‘1996’’
for ‘‘1991’’ in pars. (1) and (2).
1989—Subsec. (c). Pub. L. 101–93 inserted ‘‘and osteopathic medicine’’ after ‘‘schools of medicine’’.
1988—Subsec. (a). Pub. L. 100–690, § 2617(b)(1), which directed substitution of ‘‘through the Director of the National Institute of Allergy’’ for ‘‘through the National
Institutes of Allergy’’, was executed by making substitution for ‘‘through the National Institute of Allergy’’
as the probable intent of Congress.
Subsec. (b)(2)(B)(iii). Pub. L. 100–690, § 2617(b)(2),
which directed substitution of ‘‘Institute’’ for ‘‘Institutes’’, could not be executed because ‘‘Institute’’ was
singular in original.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.
FINDINGS AND SENSE OF CONGRESS
Section 2 of Pub. L. 102–96 provided that:
‘‘(a) FINDINGS.—Congress finds that—
‘‘(1) community-based clinical trials complement
the National Institute of Allergy and Infectious Diseases’ university-based research in order to provide
increased access to experimental therapies;
‘‘(2) community-based clinical trials provide an efficient and cost-effective means to develop new HIV-related treatments, benefiting all people living with
HIV disease and other illnesses; and
‘‘(3) because the community-based clinical trials
model has a proven ability to conduct rapid trials
that meet the very highest standards of scientific inquiry, this program should be reauthorized and significantly expanded.
‘‘(b) SENSE OF CONGRESS.—It is the sense of Congress
that, because of Terry Beirn’s tireless efforts to foster
a partnership among all parties invested in AIDS research (including the National Institutes of Health university-based research system, primary care physicians
practicing in the community, and patients), the community-based clinical trials program should be renamed as the ‘Terry Beirn Community-Based AIDS Research Initiative’ in his honor.’’

§ 300cc–14. Evaluation of certain treatments
(a) Establishment of program
(1) After consultation with the AIDS Research
Advisory Committee established pursuant to
section 300cc–3 of this title, the Secretary shall
establish a program for the evaluation of drugs
that—
(A) are not approved by the Commissioner of
Food and Drugs for the purpose of treatments
with respect to acquired immune deficiency
syndrome; and

§ 300cc–15

(B) are being utilized for such purpose by individuals infected with the etiologic agent for
such syndrome.
(2) The program established under paragraph
(1) shall include evaluations of the effectiveness
and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome
that are approved by the Commissioner of Food
and Drugs.
(b) Authority with respect to grants and contracts
(1) For the purpose of conducting evaluations
required in subsection (a) of this section, the
Secretary may make grants to, and enter into
cooperative agreements and contracts with, public and nonprofit private entities.
(2) Nonprofit private entities under paragraph
(1) may include nonprofit private organizations
that—
(A) are established for the purpose of evaluating treatments with respect to acquired immune deficiency syndrome; and
(B) consist primarily of individuals infected
with the etiologic agent for such syndrome.
(c) Scientific and ethical guidelines
(1) The Secretary shall establish appropriate
scientific and ethical guidelines for the conduct
of evaluations carried out pursuant to this section. The Secretary may not provide financial
assistance under subsection (b)(1) of this section
unless the applicant for such assistance agrees
to comply with such guidelines.
(2) The Secretary may establish the guidelines
described in paragraph (1) only after consulting
with—
(A) physicians whose clinical practice includes a significant number of individuals
with acquired immune deficiency syndrome;
(B) individuals who are infected with the
etiologic agent for such syndrome; and
(C) other individuals with appropriate expertise or experience.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2314, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3069; amended Pub. L. 103–43, title XX,
§ 2008(d)(3), June 10, 1993, 107 Stat. 212.)
PRIOR PROVISIONS
A prior section 300cc–14, act July 1, 1944, § 2315, was
successively renumbered by subsequent acts and transferred, see section 238l of this title.
AMENDMENTS
1993—Subsec. (a)(1). Pub. L. 103–43 substituted ‘‘AIDS
Research Advisory Committee’’ for ‘‘Clinical Research
Review Committee’’ in introductory provisions.

§ 300cc–15. Support of international efforts
(a) Grants and contracts for research
(1) Under section 242l of this title, the Secretary, acting through the Director of the National Institutes of Health—
(A) shall, for the purpose described in paragraph (2), make grants to, enter into coopera-

§ 300cc–16

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tive agreements and contracts with, and provide technical assistance to, international organizations concerned with public health; and
(B) may, for such purpose, provide technical
assistance to foreign governments.
(2) The purpose referred to in paragraph (1) is
promoting and expediting international research
and training concerning the natural history and
pathogenesis of the human immunodeficiency
virus and the development and evaluation of
vaccines and treatments for acquired immune
deficiency syndrome and opportunistic infections.
(b) Grants and contracts for additional purposes
After consultation with the Administrator of
the Agency for International Development, the
Secretary, acting through the Director of the
Centers for Disease Control and Prevention,
shall under section 242l of this title make grants
to, enter into contracts with, and provide technical assistance to, international organizations
concerned with public health and may provide
technical assistance to foreign governments, in
order to support—
(1) projects for training individuals with respect to developing skills and technical expertise for use in the prevention, diagnosis, and
treatment of acquired immune deficiency syndrome; and
(2) epidemiological research relating to acquired immune deficiency syndrome.
(c) Special Programme of World Health Organization
Support provided by the Secretary pursuant to
this section shall be in furtherance of the global
strategy of the World Health Organization Special Programme on Acquired Immunodeficiency
Syndrome.
(d) Preferences
In providing grants, cooperative agreements,
contracts, and technical assistance under subsections (a) and (b) of this section, the Secretary
shall—
(1) give preference to activities under such
subsections conducted by, or in cooperation
with, the World Health Organization; and
(2) with respect to activities carried out
under such subsections in the Western Hemisphere, give preference to activities conducted
by, or in cooperation with, the Pan American
Health Organization or the World Health Organization.
(e) Requirement of application
The Secretary may not make a grant or enter
into a cooperative agreement or contract under
this section unless—
(1) an application for such assistance is submitted to the Secretary;
(2) with respect to carrying out the purpose
for which such assistance is to be provided, the
application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this section.

Page 1182

(f) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each fiscal year.
(July 1, 1944, ch. 373, title XXIII, § 2315, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3070; amended Pub. L. 102–531, title III,
§ 312(d)(18), Oct. 27, 1992, 106 Stat. 3505; Pub. L.
103–43, title XVIII, § 1811(3), June 10, 1993, 107
Stat. 199.)
PRIOR PROVISIONS
A prior section 300cc–15, act July 1, 1944, § 2316, was
successively renumbered by subsequent acts and transferred, see section 238m of this title.
AMENDMENTS
1993—Subsec. (a)(2). Pub. L. 103–43, § 1811(3)(A), substituted ‘‘international research and training concerning the natural history and pathogenesis of the human
immunodeficiency virus and the development and evaluation of vaccines and treatments for acquired immune
deficiency syndrome and opportunistic infections’’ for
‘‘international research concerning the development
and evaluation of vaccines and treatments for acquired
immune deficiency syndrome’’.
Subsec. (f). Pub. L. 103–43, § 1811(3)(B), substituted
‘‘such sums as may be necessary for each fiscal year’’
for ‘‘there are authorized to be appropriated $40,000,000
for fiscal year 1989 and such sums as may be necessary
for each of the fiscal years 1990 and 1991’’.
1992—Subsec. (b). Pub. L. 102–531 substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’.

§ 300cc–16. Research centers
(a) In general
(1) The Secretary, acting through the Director
of the National Institute of Allergy and Infectious Diseases, may make grants to, and enter
into contracts with, public and nonprofit private
entities to assist such entities in planning, establishing, or strengthening, and providing basic
operating support for, centers for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for
acquired immune deficiency syndrome.
(2) A grant or contract under paragraph (1)
shall be provided in accordance with policies established by the Secretary, acting through the
Director of the National Institutes of Health,
and after consultation with the advisory council
for the National Institute of Allergy and Infectious Diseases.
(3) The Secretary shall ensure that, as appropriate, clinical research programs carried out
under paragraph (1) include as research subjects
women, children, hemophiliacs, and minorities.
(b) Use of financial assistance
(1) Financial assistance under subsection (a) of
this section may be expended for—
(A) the renovation or leasing of space;
(B) staffing and other basic operating costs,
including such patient care costs as are required for clinical research;
(C) clinical training with respect to acquired
immune deficiency syndrome (including such
training for allied health professionals); and
(D)
demonstration
purposes,
including
projects in the long-term monitoring and outpatient treatment of individuals infected with
the etiologic agent for such syndrome.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Financial assistance under subsection (a) of
this section may not be expended to provide research training for which Ruth L. Kirschstein
National Research Service Awards may be provided under section 288 of this title.
(c) Duration of support
Support of a center under subsection (a) of
this section may be for not more than five years.
Such period may be extended by the Director for
additional periods of not more than five years
each if the operations of such center have been
reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to
the Director that such period should be extended.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2316, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3071; amended Pub. L. 107–206, title I,
§ 804(c), Aug. 2, 2002, 116 Stat. 874.)
AMENDMENTS
2002—Subsec. (b)(2). Pub. L. 107–206 substituted ‘‘Ruth
L. Kirschstein National Research Service Awards’’ for
‘‘National Research Service Awards’’.

§ 300cc–17. Information services
(a) Establishment of program
The Secretary shall establish, maintain, and
operate a program with respect to information
on research, treatment, and prevention activities relating to infection with the etiologic
agent for acquired immune deficiency syndrome.
The program shall, with respect to the agencies
of the Department of Health and Human Services, be integrated and coordinated.
(b) Toll-free telephone communications for
health care entities
(1) After consultation with the Director of the
Office of AIDS Research, the Administrator of
the Health Resources and Services Administration, and the Director of the Centers for Disease
Control and Prevention, the Secretary shall provide for toll-free telephone communications to
provide medical and technical information with
respect to acquired immune deficiency syndrome to health care professionals, allied health
care providers, and to professionals providing
emergency health services.
(2) Information provided pursuant to paragraph (1) shall include—
(A) information on prevention of exposure
to, and the transmission of, the etiologic
agent for acquired immune deficiency syndrome; and
(B) information contained in the data banks
established in subsections (c) and (d) of this
section.
(c) Data bank on research information
(1) After consultation with the Director of the
Office of AIDS Research, the Director of the
Centers for Disease Control and Prevention, and
the National Library of Medicine, the Secretary
shall establish a data bank of information on

§ 300cc–17

the results of research with respect to acquired
immune deficiency syndrome conducted in the
United States and other countries.
(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. To the extent practicable, the Secretary
shall make such information available to researchers, physicians, and other appropriate individuals, of countries other than the United
States.
(d) Data bank on clinical trials and treatments
(1) After consultation with the Commissioner
of Food and Drugs, the AIDS Research Advisory
Committee established under section 300cc–3 of
this title, and the Director of the Office of AIDS
Research, the Secretary shall, in carrying out
subsection (a) of this section, establish a data
bank of information on clinical trials and treatments with respect to infection with the etiologic agent for acquired immune deficiency syndrome (hereafter in this section referred to as
the ‘‘Data Bank’’).
(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems available to individuals infected with the etiologic
agent for acquired immune deficiency syndrome,
to other members of the public, to health care
providers, and to researchers.
(e) Requirements with respect to data bank on
clinical trials and treatments
The Data Bank shall include the following:
(1) A registry of clinical trials of experimental treatments for acquired immune deficiency syndrome and related illnesses conducted under regulations promulgated pursuant to section 355 of title 21 that provides a description of the purpose of each experimental
drug protocol either with the consent of the
protocol sponsor, or when a trial to test efficacy begins. Information provided shall include eligibility criteria and the location of
trial sites, and must be forwarded to the Data
Bank by the sponsor of the trial not later than
21 days after the approval by the Food and
Drug Administration.
(2) Information pertaining to experimental
treatments for acquired immune deficiency
syndrome that may be available under a treatment investigational new drug application
that has been submitted to the Food and Drug
Administration pursuant to part 312 of title 21,
Code of Federal Regulations. The Data Bank
shall also include information pertaining to
the results of clinical trials of such treatments, with the consent of the sponsor, of
such experimental treatments, including information concerning potential toxicities or
adverse effects associated with the use or administration of such experimental treatment.
(July 1, 1944, ch. 373, title XXIII, § 2317, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3071; amended Pub. L. 100–690, title II,
§ 2617(c), Nov. 18, 1988, 102 Stat. 4240; Pub. L.
102–531, title III, § 312(d)(19), Oct. 27, 1992, 106
Stat. 3505; Pub. L. 103–43, title XX, § 2008(d)(4),
June 10, 1993, 107 Stat. 212.)

§ 300cc–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

1993—Subsec. (d)(1). Pub. L. 103–43 substituted ‘‘AIDS
Research Advisory Committee established under section 300cc–3 of this title’’ for ‘‘Clinical Research Review
Committee’’.
1992—Subsecs. (b)(1), (c)(1). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
1988—Subsec. (e). Pub. L. 100–690 substituted ‘‘data
bank on clinical trials and treatments’’ for ‘‘data
bank’’ in heading.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300cc–18. Development of model protocols for
clinical care of infected individuals
(a) In general
(1) The Secretary, acting through the Director
of the National Institutes of Health and after
consultation with the Director of the Agency for
Healthcare Research and Quality, may make
grants to public and nonprofit private entities
for the establishment of projects to develop
model protocols for the clinical care of individuals infected with the etiologic agent for acquired immune deficiency syndrome, including
treatment and prevention of HIV infection and
related conditions among women.
(2) The Secretary may not make a grant under
paragraph (1) unless—
(A) the applicant for the grant is a provider
of comprehensive primary care; or
(B) the applicant for the grant agrees, with
respect to the project carried out pursuant to
paragraph (1), to enter into a cooperative arrangement with an entity that is a provider of
comprehensive primary care.
(b) Requirement of provision of certain services
The Secretary may not make a grant under
subsection (a) of this section unless the applicant for the grant agrees that, with respect to
patients participating in the project carried out
with the grant, services provided pursuant to
the grant will include—
(1) monitoring, in clinical laboratories, of
the condition of such patients;
(2) clinical intervention for infection with
the etiologic agent for acquired immune deficiency syndrome, including measures for the
prevention of conditions arising from the infection;
(3) information and counseling on the availability of treatments for such infection approved by the Commissioner of Food and
Drugs, on the availability of treatments for
such infection not yet approved by the Commissioner, and on the reports issued by the
AIDS Research Advisory Committee under
section 300cc–3(c)(2)(B) of this title;
(4) support groups; and
(5) information on, and referrals to, entities
providing appropriate social support services.
(c) Limitation on imposition of charges for services
The Secretary may not make a grant under
subsection (a) of this section unless the appli-

Page 1184

cant for the grant agrees that, if the applicant
will routinely impose a charge for providing
services pursuant to the grant, the applicant
will not impose the charge on any individual
seeking such services who is unable to pay the
charge.
(d) Evaluation and reports
(1) The Secretary may not make a grant under
subsection (a) of this section unless the applicant for the grant agrees, with respect to the
project carried out pursuant to subsection (a) of
this section, to submit to the Secretary—
(A) information sufficient to assist in the
replication of the model protocol developed
pursuant to the project; and
(B) such reports as the Secretary may require.
(2) The Secretary shall provide for evaluations
of projects carried out pursuant to subsection
(a) of this section and shall annually submit to
the Congress a report describing such projects.
The report shall include the findings made as a
result of such evaluations and may include any
recommendations of the Secretary for appropriate administrative and legislative initiatives
with respect to the program established in this
section.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 1989 through 1991, and such sums as may
be necessary for each of the fiscal years 1994
through 1996.
(July 1, 1944, ch. 373, title XXIII, § 2318, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3073; amended Pub. L. 103–43, title XVIII,
§ 1811(4), title XX, § 2008(d)(5), June 10, 1993, 107
Stat. 199, 212; Pub. L. 106–129, § 2(b)(2), Dec. 6,
1999, 113 Stat. 1670.)
AMENDMENTS
1999—Subsec. (a)(1). Pub. L. 106–129 substituted ‘‘Director of the Agency for Healthcare Research and Quality’’ for ‘‘Administrator for Health Care Policy and Research’’.
1993—Subsec. (a)(1). Pub. L. 103–43, § 1811(4)(A), inserted ‘‘, acting through the Director of the National
Institutes of Health and after consultation with the
Administrator for Health Care Policy and Research,’’
after ‘‘The Secretary’’ and ‘‘, including treatment and
prevention of HIV infection and related conditions
among women’’ after ‘‘syndrome’’.
Subsec. (b)(3). Pub. L. 103–43, § 2008(d)(5), substituted
‘‘AIDS Research Advisory Committee’’ for ‘‘Clinical
Research Review Committee’’.
Subsec. (e). Pub. L. 103–43, § 1811(4)(B), inserted before
period at end ‘‘, and such sums as may be necessary for
each of the fiscal years 1994 through 1996’’.
TERMINATION OF REPORTING REQUIREMENTS
For termination, effective May 15, 2000, of provisions
in subsec. (d)(2) of this section relating to annual submission to Congress of reports describing projects carried out pursuant to subsec. (a) of this section, see section 3003 of Pub. L. 104–66, as amended, set out as a note
under section 1113 of Title 31, Money and Finance, and
page 94 of House Document No. 103–7.

§ 300cc–19. National blood resource education
program
After consultation with the Director of the
National Heart, Lung, and Blood Institute and

Page 1185

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Commissioner of Food and Drugs, the Secretary shall establish a program of research and
education regarding blood donations and transfusions to maintain and improve the safety of
the blood supply. Education programs shall be
directed at health professionals, patients, and
the community to—
(1) in the case of the public and patients undergoing treatment—
(A) increase awareness that the process of
donating blood is safe;
(B) promote the concept that blood donors
are contributors to a national need to maintain an adequate and safe blood supply;
(C) encourage blood donors to donate more
than once a year; and
(D) encourage repeat blood donors to recruit new donors;
(2) in the case of health professionals—
(A) improve knowledge, attitudes, and
skills of health professionals in the appropriate use of blood and blood components;
(B) increase the awareness and understanding of health professionals regarding the
risks versus benefits of blood transfusion;
and
(C) encourage health professionals to consider alternatives to the administration of
blood or blood components for their patients; and
(3) in the case of the community, increase
coordination, communication, and collaboration among community, professional, industry, and government organizations regarding
blood donation and transfusion issues.
(July 1, 1944, ch. 373, title XXIII, § 2319, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3074.)
§ 300cc–20. Additional authority with respect to
research
(a) Data collection with respect to national prevalence
(1) The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may, through representative sampling and
other appropriate methodologies, provide for the
continuous collection of data on the incidence in
the United States of cases of acquired immune
deficiency syndrome and of cases of infection
with the etiologic agent for such syndrome. The
Secretary may carry out the program of data
collection directly or through cooperative
agreements and contracts with public and nonprofit private entities.
(2) The Secretary shall encourage each State
to enter into a cooperative agreement or contract under paragraph (1) with the Secretary in
order to facilitate the prompt collection of the
most recent accurate data on the incidence of
cases described in such paragraph.
(3) The Secretary shall ensure that data collected under paragraph (1) includes data on the
demographic characteristics of the population of
individuals with cases described in paragraph
(1), including data on specific subpopulations at
risk of infection with the etiologic agent for acquired immune deficiency syndrome.
(4) In carrying out this subsection, the Secretary shall, for the purpose of assuring the util-

§ 300cc–20

ity of data collected under this section, request
entities with expertise in the methodologies of
data collection to provide, as soon as is practicable, assistance to the Secretary and to the
States with respect to the development and utilization of uniform methodologies of data collection.
(5) The Secretary shall provide for the dissemination of data collected pursuant to this
subsection. In carrying out this paragraph, the
Secretary may publish such data as frequently
as the Secretary determines to be appropriate
with respect to the protection of the public
health. The Secretary shall publish such data
not less than once each year.
(b) Epidemiological and demographic data
(1) The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall develop an epidemiological data base
and shall provide for long-term studies for the
purposes of—
(A) collecting information on the demographic characteristics of the population of individuals infected with the etiologic agent for
acquired immune deficiency syndrome and the
natural history of such infection; and
(B) developing models demonstrating the
long-term domestic and international patterns
of the transmission of such etiologic agent.
(2) The Secretary may carry out paragraph (1)
directly or through grants to, or cooperative
agreeements 1 or contracts with, public and nonprofit private entities, including Federal agencies.
(c) Long-term research
The Secretary may make grants to public and
nonprofit private entities for the purpose of assisting grantees in conducting long-term research into treatments for acquired immune deficiency syndrome developed from knowledge of
the genetic nature of the etiologic agent for
such syndrome.
(d) Social sciences research
The Secretary, acting through the Director of
the National Institute of Mental Health, may
make grants to public and nonprofit private entities for the purpose of assisting grantees in
conducting scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome.
(e) Authorization of appropriations
(1) For the purpose of carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each fiscal
year.
(2) Amounts appropriated pursuant to paragraph (1) to carry out subsection (c) of this section shall remain available until expended.
(July 1, 1944, ch. 373, title XXIII, § 2320, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3074; amended Pub. L. 100–690, title II,
§ 2617(d), Nov. 18, 1988, 102 Stat. 4240; Pub. L.
102–531, title III, § 312(d)(20), Oct. 27, 1992, 106
Stat. 3505; Pub. L. 103–43, title XVIII, § 1811(5),
(6), June 10, 1993, 107 Stat. 200.)
1 So

in original.

§ 300cc–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1186

AMENDMENTS

AMENDMENTS

1993—Subsec. (b)(1)(A). Pub. L. 103–43, § 1811(5), inserted ‘‘and the natural history of such infection’’ after
‘‘syndrome’’.
Subsec. (e)(1). Pub. L. 103–43, § 1811(6), substituted
‘‘fiscal year’’ for ‘‘of the fiscal years 1989 through 1991’’.
1992—Subsecs. (a)(1), (b)(1). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
1988—Subsec. (a)(5). Pub. L. 100–690 substituted ‘‘subsection’’ for ‘‘section’’.

1993—Subsec. (d). Pub. L. 103–43 substituted ‘‘fiscal
year’’ for ‘‘of the fiscal years 1989 through 1991’’.
1992—Subsec. (a). Pub. L. 102–531, which directed the
substitution of ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’, was executed by making the substitution in two places to reflect the probable intent of Congress.
1988—Subsec. (c). Pub. L. 100–690 substituted ‘‘date of
the enactment of the AIDS Amendments of 1988’’ for
‘‘date of the enactment of the AIDS Federal Policy Act
of 1988’’ which for purposes of codification was translated as ‘‘November 4, 1988’’.

EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

PART C—RESEARCH TRAINING
§ 300cc–31. Fellowships and training
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish fellowship and training programs
to be conducted by the Centers for Disease Control and Prevention to train individuals to develop skills in epidemiology, surveillance, testing, counseling, education, information, and laboratory analysis relating to acquired immune
deficiency syndrome. Such programs shall be designed to enable health professionals and health
personnel trained under such programs to work,
after receiving such training, in national and
international efforts toward the prevention, diagnosis, and treatment of acquired immune deficiency syndrome.
(b) Programs conducted by National Institute of
Mental Health
The Secretary, acting through the Director of
the National Institute of Mental Health, shall
conduct or support fellowship and training programs for individuals pursuing graduate or postgraduate study in order to train such individuals
to conduct scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome.
(c) Relationship to limitation on number of employees
Any individual receiving a fellowship or receiving training under subsection (a) or (b) of
this section shall not be included in any determination of the number of full-time equivalent
employees of the Department of Health and
Human Services for the purpose of any limitation on the number of such employees established by law prior to, on, or after November 4,
1988.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each fiscal year.
(July 1, 1944, ch. 373, title XXIII, § 2341, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3076; amended Pub. L. 100–690, title II,
§ 2617(e), Nov. 18, 1988, 102 Stat. 4240; Pub. L.
102–531, title III, § 312(d)(21), Oct. 27, 1992, 106
Stat. 3505; Pub. L. 103–43, title XVIII, § 1811(7),
June 10, 1993, 107 Stat. 200.)

EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

PART D—OFFICE OF AIDS RESEARCH
SUBPART I—INTERAGENCY COORDINATION OF
ACTIVITIES

AMENDMENTS
1993—Pub. L. 103–43, title XVIII, § 1801(a)(1), (3), June
10, 1993, 107 Stat. 192, added part D designation and
heading and subpart I heading and struck out former
part D designation and heading ‘‘Special Authorities of
the Director of the National Institutes of Health’’.

§ 300cc–40. Establishment of Office
(a) In general
There is established within the National Institutes of Health an office to be known as the Office of AIDS Research. The Office shall be headed by a director, who shall be appointed by the
Secretary.
(b) Duties
(1) Interagency coordination of AIDS activities
With respect to acquired immune deficiency
syndrome, the Director of the Office shall
plan, coordinate, and evaluate research and
other activities conducted or supported by the
agencies of the National Institutes of Health.
In carrying out the preceding sentence, the Director of the Office shall evaluate the AIDS
activities of each of such agencies and shall
provide for the periodic reevaluation of such
activities.
(2) Consultations
The Director of the Office shall carry out
this subpart (including developing and revising the plan required in section 300cc–40c of
this title) in consultation with the heads of
the agencies of the National Institutes of
Health, with the advisory councils of the agencies, and with the advisory council established
under section 300cc–40b of this title.
(3) Coordination
The Director of the Office shall act as the
primary Federal official with responsibility
for overseeing all AIDS research conducted or
supported by the National Institutes of
Health, and
(A) shall serve to represent the National
Institutes of Health AIDS Research Program
at all relevant Executive branch task forces
and committees; and

Page 1187

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) shall maintain communications with
all relevant Public Health Service agencies
and with various other departments of the
Federal Government, to ensure the timely
transmission of information concerning advances in AIDS research and the clinical
treatment of acquired immune deficiency
syndrome and its related conditions, between these various agencies for dissemination to affected communities and health
care providers.
(July 1, 1944, ch. 373, title XXIII, § 2351, as added
Pub. L. 103–43, title XVIII, § 1801(a)(3), June 10,
1993, 107 Stat. 192.)
§ 300cc–40a. Microbicide research
(a) Federal strategic plan
The Director of the Office shall—
(1) expedite the implementation of the Federal strategic plans required by section 283(a)
of this title regarding the conduct and support
of research on, and development of, a
microbicide to prevent the transmission of the
human immunodeficiency virus; and
(2) review and, as appropriate, revise such
plan to prioritize funding and activities relative to their scientific urgency and potential
market readiness.
(b) Coordination
In implementing, reviewing, and prioritizing
elements of the plan described in subsection (a),
the Director of the Office shall consult, as appropriate, with—
(1) representatives of other Federal agencies
involved in microbicide research, including
the Coordinator of United States Government
Activities to Combat HIV/AIDS Globally, the
Director of the Centers for Disease Control
and Prevention, and the Administrator of the
United States Agency for International Development;
(2) the microbicide research and development community; and
(3) health advocates.
(July 1, 1944, ch. 373, title XXIII, § 2351A, as
added Pub. L. 110–293, title II, § 203(b), July 30,
2008, 122 Stat. 2940.)
PRIOR PROVISIONS
A prior section 300cc–40a, act July 1, 1944, ch. 373,
title XXIII, § 2352, as added Pub. L. 103–43, title XVIII,
§ 1801(a)(3), June 10, 1993, 107 Stat. 193, which required
the establishment of an advisory council and coordinating committees, was transferred to section 300cc–40b
of this title.
SENSE OF CONGRESS
Pub. L. 110–293, title II, § 203(a), July 30, 2008, 122 Stat.
2940, provided that: ‘‘Congress recognizes the need and
urgency to expand the range of interventions for preventing the transmission of human immunodeficiency
virus (HIV), including nonvaccine prevention methods
that can be controlled by women.’’

§ 300cc–40b. Advisory Council; coordinating committees
(a) Advisory Council
(1) In general
The Secretary shall establish an advisory
council for the purpose of providing advice to

§ 300cc–40b

the Director of the Office on carrying out this
part. (Such council is referred to in this subsection as the ‘‘Advisory Council’’.)
(2) Composition, compensation, terms, chair,
etc.
Subsections (b) through (g) of section 284a of
this title apply to the Advisory Council to the
same extent and in the same manner as such
subsections apply to advisory councils for the
national research institutes, except that—
(A) in addition to the ex officio members
specified in section 284a(b)(2) of this title,
there shall serve as such members of the Advisory Council a representative from the advisory council of each of the National Cancer Institute and the National Institute on
Allergy and Infectious Diseases; and
(B) with respect to the other national research institutes, there shall serve as ex officio members of such Council, in addition to
such members specified in subparagraph (A),
a representative from the advisory council
of each of the 2 institutes that receive the
greatest funding for AIDS activities.
(b) Individual coordinating committees regarding research disciplines
(1) In general
The Director of the Office shall establish, for
each research discipline in which any activity
under the plan required in section 300cc–40c of
this title is carried out, a committee for the
purpose of providing advice to the Director of
the Office on carrying out this part with respect to such discipline. (Each such committee
is referred to in this subsection as a ‘‘coordinating committee’’.)
(2) Composition
Each coordinating committee shall be composed of representatives of the agencies of the
National Institutes of Health with significant
responsibilities regarding the research discipline involved.
(July 1, 1944, ch. 373, title XXIII, § 2352, as added
Pub. L. 103–43, title XVIII, § 1801(a)(3), June 10,
1993, 107 Stat. 193.)
CODIFICATION
Section was formerly classified to section 300cc–40a of
this title.
PRIOR PROVISIONS
A prior section 300cc–40b, act July 1, 1944, ch. 373,
title XXIII, § 2353, as added Pub. L. 103–43, title XVIII,
§ 1801(a)(3), June 10, 1993, 107 Stat. 194, which required
the establishment of a comprehensive plan, was transferred to section 300cc–40c of this title.
TERMINATION OF ADVISORY COUNCILS
Advisory councils established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a council established by the President or an officer of the Federal Government, such
council is renewed by appropriate action prior to the
expiration of such 2-year period, or in the case of a
council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.

§ 300cc–40c

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 300cc–40c. Comprehensive plan for expenditure
of appropriations
(a) In general
Subject to the provisions of this section and
other applicable law, the Director of the Office,
in carrying out section 300cc–40 of this title,
shall—
(1) establish a comprehensive plan for the
conduct and support of all AIDS activities of
the agencies of the National Institutes of
Health (which plan shall be first established
under this paragraph not later than 12 months
after June 10, 1993);
(2) ensure that the Plan establishes priorities among the AIDS activities that such
agencies are authorized to carry out;
(3) ensure that the Plan establishes objectives regarding such activities, describes the
means for achieving the objectives, and designates the date by which the objectives are
expected to be achieved;
(4) ensure that all amounts appropriated for
such activities are expended in accordance
with the Plan;
(5) review the Plan not less than annually,
and revise the Plan as appropriate; and
(6) ensure that the Plan serves as a broad,
binding statement of policies regarding AIDS
activities of the agencies, but does not remove
the responsibility of the heads of the agencies
for the approval of specific programs or
projects, or for other details of the daily administration of such activities, in accordance
with the Plan.
(b) Certain components of Plan
With respect to AIDS activities of the agencies of the National Institutes of Health, the Director of the Office shall ensure that the Plan—
(1) provides for basic research;
(2) provides for applied research;
(3) provides for research that is conducted by
the agencies;
(4) provides for research that is supported by
the agencies;
(5) provides for proposals developed pursuant
to solicitations by the agencies and for proposals developed independently of such solicitations; and
(6) provides for behavioral research and social sciences research.
(c) Budget estimates
(1) Full-funding budget
(A) With respect to a fiscal year, the Director of the Office shall prepare and submit directly to the President, for review and transmittal to the Congress, a budget estimate for
carrying out the Plan for the fiscal year, after
reasonable opportunity for comment (but
without change) by the Secretary, the Director of the National Institutes of Health, and
the advisory council established under section
300cc–40b of this title. The budget estimate

Page 1188

shall include an estimate of the number and
type of personnel needs for the Office.
(B) The budget estimate submitted under
subparagraph (A) shall estimate the amounts
necessary for the agencies of the National Institutes of Health to carry out all AIDS activities determined by the Director of the Office
to be appropriate, without regard to the probability that such amounts will be appropriated.
(2) Alternative budgets
(A) With respect to a fiscal year, the Director of the Office shall prepare and submit to
the Secretary and the Director of the National
Institutes of Health the budget estimates described in subparagraph (B) for carrying out
the Plan for the fiscal year. The Secretary and
such Director shall consider each of such estimates in making recommendations to the
President regarding a budget for the Plan for
such year.
(B) With respect to the fiscal year involved,
the budget estimates referred to in subparagraph (A) for the Plan are as follows:
(i) The budget estimate submitted under
paragraph (1).
(ii) A budget estimate developed on the assumption that the amounts appropriated
will be sufficient only for—
(I) continuing the conduct by the agencies of the National Institutes of Health of
existing AIDS activities (if approved for
continuation), and continuing the support
of such activities by the agencies in the
case of projects or programs for which the
agencies have made a commitment of continued support; and
(II) carrying out, of activities that are in
addition to activities specified in subclause (I), only such activities for which
the Director determines there is the most
substantial need.
(iii) Such other budget estimates as the
Director of the Office determines to be appropriate.
(d) Funding
(1) Authorization of appropriations
For the purpose of carrying out AIDS activities under the Plan, there are authorized to be
appropriated such sums as may be necessary
for each of the fiscal years 1994 through 1996.
(2) Receipt of funds
For the first fiscal year beginning after the
date on which the Plan first established under
subsection (a)(1) of this section has been in effect for 12 months, and for each subsequent fiscal year, the Director of the Office shall receive directly from the President and the Director of the Office of Management and Budget
all funds available for AIDS activities of the
National Institutes of Health.
(3) Allocations for agencies
(A) Each fiscal year the Director of the Office shall, from the amounts received under
paragraph (2) for the fiscal year, allocate to
the agencies of the National Institutes of
Health (in accordance with the Plan) all
amounts available for such year for carrying

Page 1189

TITLE 42—THE PUBLIC HEALTH AND WELFARE

out the AIDS activities specified in subsection
(c)(2)(B)(ii)(I) of this section for such year.
Such allocation shall, to the extent practicable, be made not later than 15 days after
the date on which the Director receives
amounts under paragraph (2).
(B) Each fiscal year the Director of the Office shall, from the amounts received under
paragraph (2) for the fiscal year, allocate to
the agencies of the National Institutes of
Health (in accordance with the Plan) all
amounts available for such year for carrying
out AIDS activities that are not referred to in
subparagraph (A). Such allocation shall, to the
extent practicable, be made not later than 30
days after the date on which the Director receives amounts under paragraph (2).
(July 1, 1944, ch. 373, title XXIII, § 2353, as added
Pub. L. 103–43, title XVIII, § 1801(a)(3), June 10,
1993, 107 Stat. 194.)
CODIFICATION
Section was formerly classified to section 300cc–40b of
this title.

§ 300cc–41. Additional authorities
(a) In general
In carrying out AIDS research, the Director of
the Office—
(1) shall develop and expand clinical trials of
treatments and therapies for infection with
the etiologic agent for acquired immune deficiency syndrome, including such clinical trials
for women, infants, children, hemophiliacs,
and minorities;
(2) may establish or support the large-scale
development and preclinical screening, production, or distribution of specialized biological materials and other therapeutic substances for AIDS research and set standards of
safety and care for persons using such materials;
(3) may support—
(A) AIDS research conducted outside the
United States by qualified foreign professionals if such research can reasonably be
expected to benefit the people of the United
States;
(B) collaborative research involving American and foreign participants; and
(C) the training of American scientists
abroad and foreign scientists in the United
States;
(4) may encourage and coordinate AIDS research conducted by any industrial concern
that evidences a particular capability for the
conduct of such research;
(5)(A) may acquire, improve, repair, operate,
and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director of the Office determines necessary;
(B) may make grants for the construction or
renovation of facilities; and
(C) may acquire, without regard to section
8141 of title 40 by lease or otherwise through
the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to
the District of Columbia for the use of the Na-

§ 300cc–41

tional Institutes of Health for a period not to
exceed ten years; and
(6) subject to section 284(b)(2) of this title
and without regard to section 3324 of title 31
and section 6101 of title 41, may enter into
such contracts and cooperative agreements
with any public agency, or with any person,
firm, association, corporation, or educational
institution, as may be necessary to expedite
and coordinate research relating to acquired
immune deficiency syndrome.
(b) Projects for cooperation among public and
private health entities
In carrying out subsection (a) of this section,
the Director of the Office shall establish
projects to promote cooperation among Federal
agencies, State, local, and regional public health
agencies, and private entities, in research concerning the diagnosis, prevention, and treatment of acquired immune deficiency syndrome.
(July 1, 1944, ch. 373, title XXIII, § 2354, formerly
§ 2351, as added Pub. L. 100–607, title II, § 201(4),
Nov. 4, 1988, 102 Stat. 3076; renumbered § 2354 and
amended Pub. L. 103–43, title XVIII, § 1801(a)(2),
(b), June 10, 1993, 107 Stat. 192, 196; Pub. L.
109–482, title I, § 104(b)(2)(D), Jan. 15, 2007, 120
Stat. 3693.)
CODIFICATION
In subsec. (a)(5)(C), ‘‘section 8141 of title 40’’ substituted for ‘‘the Act of March 3, 1877 (40 U.S.C. 34)’’ on
authority of Pub. L. 107–217, § 5(c), Aug. 21, 2002, 116
Stat. 1303, the first section of which enacted Title 40,
Public Buildings, Property, and Works.
In subsec. (a)(6), ‘‘section 6101 of title 41’’ substituted
for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’
on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124
Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS
2007—Subsecs. (b), (c). Pub. L. 109–482 redesignated
subsec. (c) as (b) and struck out former subsec. (b). Subsec. (b) text read as follows: ‘‘The Director of the Office
shall each fiscal year prepare and submit to the Secretary, for inclusion in the comprehensive report required in section 300cc(a) of this title, a report—
‘‘(1) describing and evaluating the progress made in
such fiscal year in research, treatment, and training
with respect to acquired immune deficiency syndrome conducted or supported by the Institutes;
‘‘(2) summarizing and analyzing expenditures made
in such fiscal year for activities with respect to acquired immune deficiency syndrome conducted or
supported by the National Institutes of Health; and
‘‘(3) containing such recommendations as the Director considers appropriate.’’
1993—Pub. L. 103–43, § 1801(b)(1), substituted ‘‘Additional’’ for ‘‘Establishment of’’ in section catchline.
Subsec. (a). Pub. L. 103–43, § 1801(b)(2)(A), in introductory provisions substituted ‘‘AIDS research, the Director of the Office’’ for ‘‘research with respect to acquired
immune deficiency syndrome, the Secretary, acting
through the Director of the National Institutes of
Health’’.
Subsec. (a)(1). Pub. L. 103–43, § 1801(b)(2)(B), redesignated par. (3) as (1) and struck out former par. (1) which
read as follows:
‘‘(A) shall establish an office to be known as the Office of AIDS Research, which Office shall be headed by
a Director appointed by the Director of the National
Institutes of Health; and
‘‘(B) shall provide administrative support and support
services to the Director of such Office;’’.
Subsec. (a)(2). Pub. L. 103–43, § 1801(b)(2)(B), (E), redesignated par. (4) as (2), substituted ‘‘AIDS research’’ for

§ 300cc–43

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘research relating to acquired immune deficiency syndrome’’, and struck out former par. (2) which read as
follows: ‘‘shall coordinate activities relating to acquired immune deficiency syndrome conducted by the
national research institutes and the agencies of the National Institutes of Health;’’.
Subsec. (a)(3). Pub. L. 103–43, § 1801(b)(2)(B), (C), (E),
redesignated par. (5) as (3), struck out ‘‘, in consultation with the advisory council for the appropriate national research institute of the National Institutes of
Health,’’ after ‘‘may’’ in introductory provisions, and
substituted ‘‘AIDS research’’ for ‘‘research relating to
acquired immune deficiency syndrome’’ in subpar. (A).
Former par. (3) redesignated (1).
Subsec. (a)(4). Pub. L. 103–43, § 1801(b)(2)(B), (E), redesignated par. (6) as (4) and substituted ‘‘AIDS research’’
for ‘‘research relating to acquired immune deficiency
syndrome’’. Former par. (4) redesignated (2).
Subsec. (a)(5). Pub. L. 103–43, § 1801(b)(2)(B), (D), redesignated par. (7) as (5), in subpar. (A) struck out ‘‘, in
consultation with such advisory council,’’ after ‘‘may’’
and substituted ‘‘Director of the Office determines’’ for
‘‘Director of the National Institutes of Health determines’’, and in subpars. (B) and (C) struck out ‘‘, in
consultation with such advisory council,’’ after ‘‘may’’.
Former par. (5) redesignated (3).
Subsec. (a)(6) to (8). Pub. L. 103–43, § 1801(b)(2)(B), redesignated pars. (6) to (8) as (4) to (6), respectively.
Subsec. (b). Pub. L. 103–43, § 1801(b)(3), substituted
‘‘The Director of the Office shall’’ for ‘‘The Director of
the National Institutes of Health, acting through the
Director of the Office of AIDS Research, shall’’.
Subsec. (c). Pub. L. 103–43, § 1801(b)(4), substituted
‘‘the Director of the Office shall’’ for ‘‘the Director of
the National Institutes of Health shall’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART II—EMERGENCY DISCRETIONARY FUND

§ 300cc–43. Emergency Discretionary Fund
(a) In general
(1) Establishment
There is established a fund consisting of
such amounts as may be appropriated under
subsection (g) of this section. Subject to the
provisions of this section, the Director of the
Office, after consultation with the advisory
council established under section 300cc–40b of
this title, may expend amounts in the Fund
for the purpose of conducting and supporting
such AIDS activities, including projects of
AIDS research, as may be authorized in this
chapter for the National Institutes of Health.
(2) Preconditions to use of Fund
Amounts in the Fund may be expended only
if—
(A) the Director identifies the particular
set of AIDS activities for which such
amounts are to be expended;
(B) the set of activities so identified constitutes either a new project or additional
AIDS activities for an existing project;
(C) the Director of the Office has made a
determination that there is a significant
need for such set of activities; and
(D) as of June 30 of the fiscal year preceding the fiscal year in which the determination is made, such need was not provided for
in any appropriations Act passed by the

Page 1190

House of Representatives to make appropriations for the Departments of Labor, Health
and Human Services (including the National
Institutes of Health), Education, and related
agencies for the fiscal year in which the determination is made.
(3) Two-year use of Fund for project involved
In the case of an identified set of AIDS activities, obligations of amounts in the Fund
may not be made for such set of activities
after the expiration of the 2-year period beginning on the date on which the initial obligation of such amounts is made for such set.
(b) Peer review
With respect to an identified set of AIDS activities carried out with amounts in the Fund,
this section may not be construed as waiving applicable requirements for peer review.
(c) Limitations on use of Fund
(1) Construction of facilities
Amounts in the Fund may not be used for
the construction, renovation, or relocation of
facilities, or for the acquisition of land.
(2) Congressional disapproval of projects
(A) Amounts in the Fund may not be expended for the fiscal year involved for an identified set of AIDS activities, or a category of
AIDS activities, for which—
(i)(I) amounts were made available in an
appropriations Act for the preceding fiscal
year; and
(II) amounts are not made available in any
appropriations Act for the fiscal year involved; or
(ii) amounts are by law prohibited from
being expended.
(B) A determination under subparagraph
(A)(i) of whether amounts have been made
available in appropriations Acts for a fiscal
year shall be made without regard to whether
such Acts make available amounts for the
Fund.
(3) Investment of Fund amounts
Amounts in the Fund may not be invested.
(d) Applicability of limitation regarding number
of employees
The purposes for which amounts in the Fund
may be expended include the employment of individuals necessary to carry out identified sets
of AIDS activities approved under subsection (a)
of this section. Any individual employed under
the preceding sentence may not be included in
any determination of the number of full-time
equivalent employees for the Department of
Health and Human Services for the purpose of
any limitation on the number of such employees
established by law prior to, on, or after June 10,
1993.
(e) Definitions
For purposes of this section:
(1) The term ‘‘Fund’’ means the fund established in subsection (a) of this section.
(2) The term ‘‘identified set of AIDS activities’’ means a particular set of AIDS activities
identified under subsection (a)(2)(A) of this
section.

Page 1191

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Funding
(1) Authorization of appropriations
For the purpose of providing amounts for the
Fund, there is authorized to be appropriated
$100,000,000 for each of the fiscal years 1994
through 1996.
(2) Availability
Amounts appropriated for the Fund are
available until expended.
(July 1, 1944, ch. 373, title XXIII, § 2356, as added
Pub. L. 103–43, title XVIII, § 1802, June 10, 1993,
107 Stat. 196; amended Pub. L. 109–482, title I,
§ 104(b)(2)(E), Jan. 15, 2007, 120 Stat. 3693.)
AMENDMENTS
2007—Subsecs. (e) to (g). Pub. L. 109–482 redesignated
subsecs. (f) and (g) as (e) and (f), respectively, and
struck out heading and text of former subsec. (e). Text
read as follows: ‘‘Not later than February 1 of each fiscal year, the Director of the Office shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report on the identified sets of AIDS activities carried out during the preceding fiscal year with amounts in the Fund. The report shall provide a description of each such set of activities and an explanation of the reasons underlying
the use of the Fund for the set.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
SUBPART III—GENERAL PROVISIONS

§ 300cc–45. General provisions regarding Office
(a) Administrative support for Office
The Secretary, acting through the Director of
the National Institutes of Health, shall provide
administrative support and support services to
the Director of the Office and shall ensure that
such support takes maximum advantage of existing administrative structures at the agencies
of the National Institutes of Health.
(b) Evaluation
Not later than 5 years after June 10, 1993, the
Secretary shall conduct an evaluation to—
(1) determine the effect of this section on
the planning and coordination of the AIDS research programs at the institutes, centers and
divisions of the National Institutes of Health;
(2) evaluate the extent to which this part
has eliminated the duplication of administrative resources among such Institutes, centers
and divisions; and
(3) provide recommendations concerning future alterations with respect to this part.
(c) Definitions
For purposes of this part:
(1) The term ‘‘AIDS activities’’ means AIDS
research and other activities that relate to acquired immune deficiency syndrome.
(2) The term ‘‘AIDS research’’ means research with respect to acquired immune deficiency syndrome.
(3) The term ‘‘Office’’ means the Office of
AIDS Research.

§§ 300dd to 300dd–14

(4) The term ‘‘Plan’’ means the plan required
in section 300cc–40c(a)(1) of this title.
(July 1, 1944, ch. 373, title XXIII, § 2359, as added
Pub. L. 103–43, title XVIII, § 1803, June 10, 1993,
107 Stat. 198; amended Pub. L. 109–482, title I,
§ 104(b)(2)(F), Jan. 15, 2007, 120 Stat. 3693.)
AMENDMENTS
2007—Subsec. (b). Pub. L. 109–482 substituted ‘‘Evaluation’’ for ‘‘Evaluation and report’’ in heading, struck
out par. (1) designation before ‘‘Not later than’’, redesignated subpars. (A) to (C) as pars. (1) to (3), respectively, and struck out heading and text of former par.
(2). Text read as follows: ‘‘Not later than 1 year after
the date on which the evaluation is commenced under
paragraph (1), the Secretary shall prepare and submit
to the Committee on Labor and Human Resources of
the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report concerning the results of such evaluation.’’
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.

PART E—GENERAL PROVISIONS
§ 300cc–51. Definitions
For purposes of this subchapter:
(1) The term ‘‘infection’’, with respect to the
etiologic agent for acquired immune deficiency syndrome, includes opportunistic cancers and infectious diseases and any other conditions arising from infection with such etiologic agent.
(2) The term ‘‘treatment’’, with respect to
the etiologic agent for acquired immune deficiency syndrome, includes primary and secondary prophylaxis.
(July 1, 1944, ch. 373, title XXIII, § 2361, as added
Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102
Stat. 3078; amended Pub. L. 103–43, title XVIII,
§ 1811(8), June 10, 1993, 107 Stat. 200.)
AMENDMENTS
1993—Pub. L. 103–43 substituted provisions defining
‘‘infection’’ and ‘‘treatment’’ for former provisions
which read as follows: ‘‘For purposes of this subchapter, the term ‘infection with the etiologic agent
for acquired immune deficiency syndrome’ includes any
condition arising from infection with such etiologic
agent’’.

SUBCHAPTER
XXII—HEALTH
SERVICES
WITH RESPECT TO ACQUIRED IMMUNE
DEFICIENCY SYNDROME
PART A—FORMULA GRANTS TO STATES FOR
HOME AND COMMUNITY-BASED HEALTH SERVICES
§§ 300dd to 300dd–14. Repealed. July 1, 1944, ch.
373, title XXIV, § 2415, as added Nov. 4, 1988,
Pub. L. 100–607, title II, § 211, 102 Stat. 3088;
amended Nov. 18, 1988, Pub. L. 100–690, title
II, § 2618(g), 102 Stat. 4241
Section 300dd, act July 1, 1944, ch. 373, title XXIV,
§ 2401, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3079, established program of formula
grants for home and community-based health services.
Section 300dd–1, act July 1, 1944, ch. 373, title XXIV,
§ 2402, as added Nov. 4, 1988, Pub. L. 100–607, title II,

§ 300dd–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 211, 102 Stat. 3080; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(a), 102 Stat. 4240, provided requirements for carrying out purpose of grants.
Section 300dd–2, act July 1, 1944, ch. 373, title XXIV,
§ 2403, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3081, required submission of description
of intended uses of grant.
Section 300dd–3, act July 1, 1944, ch. 373, title XXIV,
§ 2404, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3081; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(b), 102 Stat. 4240, restricted use of
grants.
Section 300dd–4, act July 1, 1944, ch. 373, title XXIV,
§ 2405, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3082, required reports and audits by
States.
Section 300dd–5, act July 1, 1944, ch. 373, title XXIV,
§ 2406, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3083, required additional agreements.
Section 300dd–6, act July 1, 1944, ch. 373, title XXIV,
§ 2407, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3084, required submission of application
containing certain agreements and assurances.
Section 300dd–7, act July 1, 1944, ch. 373, title XXIV,
§ 2408, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3084, provided for determination of
amount of allotments for States.
Section 300dd–8, act July 1, 1944, ch. 373, title XXIV,
§ 2409, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3085; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(c), 102 Stat. 4241, related to failure
to comply with agreements.
Section 300dd–9, act July 1, 1944, ch. 373, title XXIV,
§ 2410, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3087, prohibited certain false statements.
Section 300dd–10, act July 1, 1944, ch. 373, title XXIV,
§ 2411, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3087; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(d), 102 Stat. 4241, authorized the
Secretary to provide technical assistance and supplies
and services in lieu of grant funds.
Section 300dd–11, act July 1, 1944, ch. 373, title XXIV,
§ 2412, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3087, required report by Secretary.
Section 300dd–12, act July 1, 1944, ch. 373, title XXIV,
§ 2413, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3087; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(e), 102 Stat. 4241, defined terms for
this part.
Section 300dd–13, act July 1, 1944, ch. 373, title XXIV,
§ 2414, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3088; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(f), 102 Stat. 4241, provided funding.
Section 300dd–14, act July 1, 1944, ch. 373, title XXIV,
§ 2415, as added Nov. 4, 1988, Pub. L. 100–607, title II,
§ 211, 102 Stat. 3088; amended Nov. 18, 1988, Pub. L.
100–690, title II, § 2618(g), 102 Stat. 4241, repealed this
part effective with respect to appropriations made for
any period after fiscal year 1990.
EFFECTIVE DATE OF REPEAL
Repeal effective with respect to appropriations made
for any period after fiscal year 1990, see section 2415 of
act July 1, 1944, which was classified to former section
300dd–14 of this title.

PART B—SUBACUTE CARE
§ 300dd–21. Demonstration projects
(a) Definitions
As used in this section:
(1) The term ‘‘individuals infected with the
etiologic agent for acquired immune deficiency syndrome’’ means individuals who have
a disease, or are recovering from a disease, attributable to the infection of such individuals
with such etiologic agent, and as a result of
the effects of such disease, are in need of
subacute-care services.

Page 1192

(2) The term ‘‘subacute care’’ means medical
and health care services that are required for
individuals recovering from acute care episodes that are less intensive than the level of
care provided in acute-care hospitals, and includes skilled nursing care, hospice care, and
other types of health services provided in
other long-term-care facilities.
(b) Authorization to conduct three projects
The Secretary shall conduct three demonstration projects to determine the effectiveness and
cost of providing the subacute-care services described in subsection (b) of this section to individuals infected with the etiologic agent for acquired immune deficiency syndrome, and the
impact of such services on the health status of
such individuals.
(c) Services
(1) The services provided under each demonstration project shall be designed to meet the
specific needs of individuals infected with the
etiologic agent for acquired immune deficiency
syndrome, and shall include—
(A) the care and treatment of such individuals by providing—
(i) subacute care;
(ii) emergency medical care and specialized diagnostic and therapeutic services as
needed and where appropriate, either directly or through affiliation with a hospital
that has experience in treating individuals
with acquired immune deficiency syndrome;
and
(iii) case management services to ensure,
through existing services and programs
whenever possible, appropriate discharge
planning for such individuals; and
(B) technical assistance, to other facilities
in the region served by such facility, that is
directed toward education and training of physicians, nurses, and other health-care professionals in the subacute care and treatment of
individuals infected with the etiologic agent
for acquired immune deficiency syndrome.
(2) Services provided under each demonstration project may also include—
(A) hospice services;
(B) outpatient care; and
(C) outreach activities in the surrounding
community to hospitals and other health-care
facilities that serve individuals infected with
the etiologic agent for acquired immune deficiency syndrome.
(d) Time and place
The demonstration projects shall be conducted—
(1) during a 4-year period beginning not later
than 9 months after November 4, 1988; and
(2) at sites that—
(A) are geographically diverse and located
in areas that are appropriate for the provision of the required and authorized services;
and
(B) have the highest incidence of cases of
acquired immune deficiency syndrome and
the greatest need for subacute-care services.
(e) Evaluation and report
The Secretary shall evaluate the operations of
the demonstration projects and shall submit to

Page 1193

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate—
(1) not later than 18 months after the beginning of the first project, a preliminary report
that contains—
(A) a description of the sites at which the
projects are being conducted and of the services being provided in each project; and
(B) a preliminary evaluation of the experience of the projects in the first 12 months of
operation; and
(2) not later than 6 months after the completion of the last project, a final report that
contains—
(A) an assessment of the costs of subacute
care for individuals infected with the etiologic agent for acquired immune deficiency
syndrome, including a breakdown of all
other sources of funding for the care provided to cover subacute care; and
(B) recommendations for appropriate legislative changes.
(f) Other research
Each demonstration project shall provide for
other research to be carried out at the site of
such demonstration project including—
(1) clinical research on acquired immune deficiency syndrome, concentrating on research
on the neurological manifestations resulting
from infection with the etiologic agent for
such syndrome; and
(2) the study of the psychological and mental health issues related to such syndrome.
(g) Authorization of appropriations
(1) To carry out this section, there are authorized to be appropriated $10,000,000 for fiscal year
1989 and such sums as are necessary for each of
the fiscal years 1990 through 1992.
(2) Amounts appropriated pursuant to paragraph (1) shall remain available until September
10, 1992.
(h) Services to veterans
The Secretary shall enter into an agreement
with the Secretary of the Department of Veterans Affairs to ensure that appropriate provision
will be made for the furnishing, through demonstration projects, of services to eligible veterans, under contract with the Department of Veterans Affairs pursuant to section 1720 of title 38.
(July 1, 1944, ch. 373, title XXIV, § 2421, as added
Pub. L. 100–607, title II, § 211, Nov. 4, 1988, 102
Stat. 3088; amended Pub. L. 100–527, § 10(1), (2),
Oct. 25, 1988, 102 Stat. 2640, 2641; Pub. L. 100–690,
title II, § 2618(h), Nov. 18, 1988, 102 Stat. 4241;
Pub. L. 102–83, § 5(c)(2), Aug. 6, 1991, 105 Stat.
406.)
AMENDMENTS
1991—Subsec. (h). Pub. L. 102–83 substituted ‘‘section
1720 of title 38’’ for ‘‘section 620 of title 38’’.
1988—Subsec. (a)(1). Pub. L. 100–690, § 2618(h)(1), substituted ‘‘ ‘individuals infected with the etiologic agent
for acquired immune deficiency syndrome’ means individuals who’’ for ‘‘ ‘patients infected with the human
immunodeficiency virus’ means persons who’’ and
‘‘such individuals with such etiologic agent’’ for ‘‘such
person with the human immunodeficiency virus’’.
Subsec. (a)(2). Pub. L. 100–690, § 2618(h)(2), substituted
‘‘individuals’’ for ‘‘persons’’.

§ 300dd–21

Subsec. (b). Pub. L. 100–690, § 2618(h)(3), substituted
‘‘individuals infected with the etiologic agent for acquired immune deficiency syndrome’’ for ‘‘patients infected with the human immunodeficiency virus’’ and
‘‘such individuals’’ for ‘‘such patients’’.
Subsec. (c)(1). Pub. L. 100–690, § 2618(h)(4)(A), in introductory provisions substituted ‘‘individuals infected
with the etiologic agent for acquired immune deficiency syndrome’’ for ‘‘patients infected with the
human immunodeficiency virus’’.
Subsec. (c)(1)(A). Pub. L. 100–690, § 2618(h)(4)(B), substituted in introductory provisions ‘‘such individuals’’
for ‘‘such patients’’, in cl. (ii) ‘‘individuals with acquired immune deficiency syndrome’’ for ‘‘AIDS patients’’, and in cl. (iii) ‘‘such individuals’’ for ‘‘patients’’.
Subsec. (c)(1)(B), (2)(C). Pub. L. 100–690, § 2618(h)(4)(C),
(5), substituted ‘‘individuals infected with the etiologic
agent for acquired immune deficiency syndrome’’ for
‘‘patients infected with the human immunodeficiency
virus’’.
Subsec. (d)(2)(B). Pub. L. 100–690, § 2618(h)(6), substituted ‘‘cases of acquired immune deficiency syndrome’’ for ‘‘AIDS cases’’.
Subsec. (e)(2)(A). Pub. L. 100–690, § 2618(h)(7), substituted ‘‘individuals infected with the etiologic agent
for acquired immune deficiency syndrome’’ for ‘‘patients infected with the human immunodeficiency
virus’’.
Subsec. (f)(1). Pub. L. 100–690, § 2618(h)(8), substituted
‘‘acquired immune deficiency syndrome’’ for ‘‘the acquired immunodeficiency syndrome’’ and ‘‘etiologic
agent for such syndrome’’ for ‘‘human immunodeficiency virus’’.
Subsec. (f)(2). Pub. L. 100–690, § 2618(h)(9), substituted
‘‘such syndrome’’ for ‘‘the acquired immunodeficiency
syndrome’’.
Subsec. (g)(1). Pub. L. 100–690, § 2618(h)(10), substituted
‘‘fiscal year 1989’’ for ‘‘fiscal year 1988’’ and ‘‘fiscal
years 1990 through 1992’’ for ‘‘fiscal years 1989 through
1991’’.
Subsec. (h). Pub. L. 100–527 substituted ‘‘Secretary of
the Department of Veterans Affairs’’ and ‘‘Department
of Veterans Affairs’’ for ‘‘Administrator of the Veterans’ Administration’’ and ‘‘Veterans’ Administration’’,
respectively.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
EFFECTIVE DATE OF 1988 AMENDMENTS
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
Amendment by Pub. L. 100–527 effective Mar. 15, 1989,
see section 18(a) of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 301 of
Title 38, Veterans’ Benefits.

PART C—OTHER HEALTH SERVICES
CODIFICATION
Prior to revision by Pub. L. 102–321, this part was
comprised of subpart I, consisting of sections 300dd–31

§ 300dd–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to 300dd–33, and subpart II, consisting of section
300dd–41.

§ 300dd–31. Grants for anonymous testing
The Secretary may make grants to the States
for the purpose of providing opportunities for individuals—
(1) to undergo counseling and testing with
respect to the etiologic agent for acquired immune deficiency syndrome without being required to provide any information relating to
the identity of the individuals; and
(2) to undergo such counseling and testing
through the use of a pseudonym.
(July 1, 1944, ch. 373, title XXIV, § 2431, as added
Pub. L. 100–607, title II, § 211, Nov. 4, 1988, 102
Stat. 3090.)
§ 300dd–32. Requirement of provision of certain
counseling services
(a) Counseling before testing
The Secretary may not make a grant under
section 300dd–31 of this title to a State unless
the State agrees that, before testing an individual pursuant to such section, the State will provide to the individual appropriate counseling
with respect to acquired immune deficiency syndrome (based on the most recent scientific data
relating to such syndrome), including—
(1) measures for the prevention of exposure
to, and the transmission of, the etiologic
agent for such syndrome;
(2) the accuracy and reliability of the results
of such testing;
(3) the significance of the results of such
testing, including the potential for developing
acquired immune deficiency syndrome; and
(4) encouraging individuals, as appropriate,
to undergo testing for such etiologic agent and
providing information on the benefits of such
testing.
(b) Counseling of individuals with negative test
results
The Secretary may not make a grant under
section 300dd–31 of this title to a State unless
the State agrees that, if the results of testing
conducted pursuant to such section indicate
that an individual is not infected with the etiologic agent for acquired immune deficiency syndrome, the State will review for the individual
the information provided pursuant to subsection
(a) of this section with respect to such syndrome, including—
(1) the information described in paragraphs
(1) through (3) of such subsection; and
(2) the appropriateness of further counseling,
testing, and education of the individual with
respect to acquired immune deficiency syndrome.
(c) Counseling of individuals with positive test
results
The Secretary may not make a grant under
section 300dd–31 of this title to a State unless
the State agrees that, if the results of testing
conducted pursuant to such section indicate
that an individual is infected with the etiologic
agent for acquired immune deficiency syndrome,
the State will provide to the individual appro-

Page 1194

priate counseling with respect to such syndrome, including—
(1) reviewing the information described in
paragraphs (1) through (3) of subsection (a) of
this section;
(2) reviewing the appropriateness of further
counseling, testing, and education of the individual with respect to acquired immune deficiency syndrome;
(3) the importance of not exposing others to
the etiologic agent for acquired immune deficiency syndrome;
(4) the availability in the geographic area of
any appropriate services with respect to
health care, including mental health care and
social and support services;
(5) the benefits of locating and counseling
any individual by whom the infected individual may have been exposed to the etiologic
agent for acquired immune deficiency syndrome and any individual whom the infected
individual may have exposed to such etiologic
agent; and
(6) the availability, if any, of the services of
public health authorities with respect to locating and counseling any individual described
in paragraph (5).
(d) Rule of construction with respect to counseling without testing
Agreements entered into pursuant to subsections (a) through (c) of this section may not
be construed to prohibit any grantee under section 300dd–31 of this title from expending the
grant for the purpose of providing counseling
services described in such subsections to an individual who will not undergo testing described in
such section as a result of the grantee or the individual determining that such testing of the individual is not appropriate.
(e) Use of funds
(1) The purpose of this subpart 1 is to provide
for counseling and testing services to prevent
and reduce exposure to, and transmission of, the
etiologic agent for acquired immune deficiency
syndrome.
(2) All individuals receiving counseling pursuant to this subpart 1 are to be counseled about
the harmful effects of promiscuous sexual activity and intravenous substance abuse, and the
benefits of abstaining from such activities.
(3) None of the fund appropriated to carry out
this subpart 1 may be used to provide counseling
that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous drug abuse.
(4) Paragraph (3) may not be construed to prohibit a counselor who has already performed the
counseling of an individual required by paragraph (2), to provide accurate information about
means to reduce an individual’s risk of exposure
to, or the transmission of, the etiologic agent
for acquired immune deficiency syndrome, provided that any informational materials used are
not obscene.
(July 1, 1944, ch. 373, title XXIV, § 2432, as added
Pub. L. 100–607, title II, § 211, Nov. 4, 1988, 102
Stat. 3090; amended Pub. L. 100–690, title II,
1 So

in original. Probably should be ‘‘part’’.

Page 1195

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 2618(i), Nov. 18, 1988, 102 Stat. 4242; Pub. L.
102–321, title I, § 118(b)(1)(B), July 10, 1992, 106
Stat. 348.)
AMENDMENTS
1992—Subsec. (a). Pub. L. 102–321, which directed the
substitution of ‘‘part’’ for ‘‘subpart’’ wherever appearing in subsec. (a), could not be executed because the
word ‘‘subpart’’ does not appear in subsec. (a).
1988—Subsec. (c). Pub. L. 100–690, § 2618(i)(1), substituted ‘‘indicate that an individual’’ for ‘‘indicate
that the individual’’ in introductory provisions and
‘‘paragraph (5)’’ for ‘‘paragraph (4)’’ in par. (6).
Subsec. (e)(1) to (3). Pub. L. 100–690, § 2618(i)(2), substituted ‘‘subpart’’ for ‘‘part’’.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300dd–33. Funding
For the purpose of grants under section
300dd–31 of this title, there are authorized to be
appropriated $100,000,000 for each of the fiscal
years 1989 and 1990.
(July 1, 1944, ch. 373, title XXIV, § 2433, as added
Pub. L. 100–607, title II, § 211, Nov. 4, 1988, 102
Stat. 3091.)
§ 300dd–41. Transferred
CODIFICATION
Section, act July 1, 1944, ch. 373, title XXIV, § 2441, as
added Nov. 4, 1988, Pub. L. 100–607, title II, § 211, 102
Stat. 3092, which related to demonstration projects for
individuals with positive AIDS test results, was renumbered section 520B of act July 1, 1944, by Pub. L. 102–321,
title I, § 118(a), July 10, 1992, 106 Stat. 348, and was
transferred to section 290bb–33 of this title, prior to repeal by Pub. L. 106–310, div. B, title XXXII, § 3201(b)(2),
Oct. 17, 2000, 114 Stat. 1190.

SUBCHAPTER XXIII—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
§ 300ee. Use of funds
(a) In general
The purpose of this subchapter is to provide
for the establishment of education and information programs to prevent and reduce exposure
to, and the transmission of, the etiologic agent
for acquired immune deficiency syndrome.
(b) Contents of programs
All programs of education and information receiving funds under this subchapter shall include information about the harmful effects of
promiscuous sexual activity and intravenous
substance abuse, and the benefits of abstaining
from such activities.
(c) Limitation
None of the funds appropriated to carry out
this subchapter may be used to provide education or information designed to promote or
encourage, directly, homosexual or heterosexual
sexual activity or intravenous substance abuse.

§ 300ee–1

(d) Construction
Subsection (c) of this section may not be construed to restrict the ability of an education
program that includes the information required
in subsection (b) of this section to provide accurate information about various means to reduce
an individual’s risk of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
informational materials used are not obscene.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2500, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3093; amended Pub. L.
100–690, title II, § 2619(a), Nov. 18, 1988, 102 Stat.
4242; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
AMENDMENTS
1988—Subsec. (a). Pub. L. 100–690 substituted ‘‘this
subchapter’’ for ‘‘this part’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–1. Establishment of office with respect to
minority health and acquired immune deficiency syndrome
The Secretary of Health and Human Services,
acting through the Director of the Centers for
Disease Control and Prevention, shall establish
an office for the purpose of ensuring that, in carrying out the duties of the Secretary with respect to prevention of acquired immune deficiency syndrome, the Secretary develops and
implements prevention programs targeted at
minority populations and provides appropriate
technical assistance in the implementation of
such programs.
(Pub. L. 100–607, title II, § 252, Nov. 4, 1988, 102
Stat. 3108; Pub. L. 102–531, title III, § 312(e)(2),
Oct. 27, 1992, 106 Stat. 3506.)
CODIFICATION
Section was enacted as part of the AIDS Amendments
of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
1992—Pub. L. 102–531 substituted ‘‘Centers for Disease
Control and Prevention’’ for ‘‘Centers for Disease Control’’.
REQUIREMENT OF STUDY WITH RESPECT TO MINORITY
HEALTH AND ACQUIRED IMMUNE DEFICIENCY SYNDROME
Section 251 of Pub. L. 100–607, as amended by Pub. L.
100–690, title II, § 2602(b), Nov. 18, 1988, 102 Stat. 4234,
provided that:
‘‘(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the Office of Minority Health, shall conduct a study for the
purpose of determining—
‘‘(1) the level of knowledge within minority communities concerning acquired immune deficiency
syndrome, the risks of the transmission of the etiologic agent for such syndrome, and the means of reducing such risk; and
‘‘(2) the effectiveness of Federal, State, and local
prevention programs with respect to acquired immune deficiency syndrome in minority communities.

§ 300ee–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(b) REPORT.—The Secretary shall, not later than 12
months after the date of the enactment of this title
[Nov. 4, 1988], complete the study required in subsection
(a) and submit to the Congress a report describing the
findings made as a result of the study.’’

§ 300ee–2. Information for health and public safety workers
(a) Development and dissemination of guidelines
Not later than 90 days after November 4, 1988,
the Secretary of Health and Human Services
(hereafter in this section referred to as the
‘‘Secretary’’), acting through the Director of the
Centers for Disease Control and Prevention,
shall develop, issue, and disseminate emergency
guidelines to all health workers and public safety workers (including emergency response employees) in the United States concerning—
(1) methods to reduce the risk in the workplace of becoming infected with the etiologic
agent for acquired immune deficiency syndrome; and
(2) circumstances under which exposure to
such etiologic agent may occur.
(b) Use in occupational standards
The Secretary shall transmit the guidelines issued under subsection (a) of this section to the
Secretary of Labor for use by the Secretary of
Labor in the development of standards to be issued under the Occupational Safety and Health
Act of 1970 [29 U.S.C. 651 et seq.].
(c) Development and dissemination of model curriculum for emergency response employees
(1) Not later than 90 days after November 4,
1988, the Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall develop a model curriculum for emergency response employees with respect to the
prevention of exposure to the etiologic agent for
acquired immune deficiency syndrome during
the process of responding to emergencies.
(2) In carrying out paragraph (1), the Secretary shall consider the guidelines issued by
the Secretary under subsection (a) of this section.
(3) The model curriculum developed under
paragraph (1) shall, to the extent practicable, include—
(A) information with respect to the manner
in which the etiologic agent for acquired immune deficiency syndrome is transmitted; and
(B) information that can assist emergency
response employees in distinguishing between
conditions in which such employees are at risk
with respect to such etiologic agent and conditions in which such employees are not at risk
with respect 1 such etiologic agent.
(4) The Secretary shall establish a task force
to assist the Secretary in developing the model
curriculum required in paragraph (1). The Secretary shall appoint to the task force representatives of the Centers for Disease Control and
Prevention, representatives of State governments, and representatives of emergency response employees.
(5) The Secretary shall—
(A) transmit to State public health officers
copies of the guidelines and the model curricu1 So

in original. Probably should be ‘‘respect to’’.

Page 1196

lum developed under paragraph (1) with the request that such officers disseminate such copies as appropriate throughout the State; and
(B) make such copies available to the public.
(Pub. L. 100–607, title II, § 253, Nov. 4, 1988, 102
Stat. 3108; Pub. L. 100–690, title II, § 2602(c), Nov.
18, 1988, 102 Stat. 4234; Pub. L. 102–531, title III,
§ 312(e)(3), Oct. 27, 1992, 106 Stat. 3506.)
REFERENCES IN TEXT
The Occupational Safety and Health Act of 1970, referred to in subsec. (b), is Pub. L. 91–596, Dec. 29, 1970,
84 Stat. 1590, as amended, which is classified principally
to chapter 15 (§ 651 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see Short
Title note set out under section 651 of Title 29 and
Tables.
CODIFICATION
Section was enacted as part of the AIDS Amendments
of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
1992—Subsecs. (a), (c)(1), (4). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’
for ‘‘Centers for Disease Control’’.
1988—Subsec. (a). Pub. L. 100–690 substituted ‘‘health
workers and public safety workers’’ for ‘‘health workers, public safety workers’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
GUIDELINES FOR PREVENTION OF TRANSMISSION OF
HUMAN IMMUNODEFICIENCY AND HEPATITIS B VIRUSES
DURING INVASIVE PROCEDURES
Pub. L. 102–141, title VI, § 633, Oct. 28, 1991, 105 Stat.
876, provided that: ‘‘Notwithstanding any other provision of law, each State Public Health Official shall, not
later than one year after the date of enactment of this
Act [Oct. 28, 1991], certify to the Secretary of Health
and Human Services that guidelines issued by the Centers for Disease Control, or guidelines which are equivalent to those promulgated by the Centers for Disease
Control concerning recommendations for preventing
the transmission of the human immunodeficiency virus
and the hepatitis B virus during exposure prone invasive procedures, except for emergency situations when
the patient’s life or limb is in danger, have been instituted in the State. State guidelines shall apply to
health professionals practicing within the State and
shall be consistent with Federal law. Compliance with
such guidelines shall be the responsibility of the State
Public Health Official. Said responsibilities shall include a process for determining what appropriate disciplinary or other actions shall be taken to ensure compliance. If such certification is not provided under this
section within the one-year period, the State shall be
ineligible to receive assistance under the Public Health
Service Act (42 U.S.C. 301 [201] et seq.) until such certification is provided, except that the Secretary may
extend the time period for a State, upon application of
such State, that additional time is required for instituting said guidelines.’’
[Centers for Disease Control changed to Centers for
Disease Control and Prevention by Pub. L. 102–531, title
III, § 312, Oct. 27, 1992, 106 Stat. 3504.]

§ 300ee–3. Continuing education for health care
providers
(a) In general
The Secretary of Health and Human Services
(hereafter in this section referred to as the

Page 1197

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘Secretary’’) may make grants to nonprofit organizations composed of, or representing, health
care providers to assist in the payment of the
costs of projects to train such providers concerning—
(1) appropriate infection control procedures
to reduce the transmission of the etiologic
agent for acquired immune deficiency syndrome; and
(2) the provision of care and treatment to individuals with such syndrome or related illnesses.
(b) Limitation
The Secretary may make a grant under subsection (a) of this section to an entity only if
the entity will provide services under the grant
in a geographic area, or to a population of individuals, not served by a program substantially
similar to the program described in subsection
(a) of this section.
(c) Requirement of matching funds
(1) The Secretary may not make a grant under
subsection (a) of this section unless the applicant for the grant agrees, with respect to the
costs to be incurred by the applicant in carrying
out the purpose described in such subsection, to
make available, directly or through donations
from public or private entities, non-Federal contributions (in cash or in kind under paragraph
(2)) toward such costs in an amount equal to not
less than $2 for each $1 of Federal funds provided
in such payments.
(2) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the amount
of such non-Federal contributions.
(d) Requirement of application
The Secretary may not make a grant under
subsection (a) of this section unless—
(1) an application for the grant is submitted
to the Secretary;
(2) with respect to carrying out the purpose
for which the grant is to be made, the application provides assurances of compliance satisfactory to the Secretary; and
(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this section.
(e) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of the fiscal
years 1989 through 1991.
(Pub. L. 100–607, title II, § 254, Nov. 4, 1988, 102
Stat. 3109.)
CODIFICATION
Section was enacted as part of the AIDS Amendments
of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health
Service Act which comprises this chapter.

§ 300ee–11

§ 300ee–4. Technical assistance
The Secretary of Health and Human Services
shall provide technical assistance to public and
nonprofit private entities carrying out programs, projects, and activities relating to acquired immune deficiency syndrome.
(Pub. L. 100–607, title II, § 255, Nov. 4, 1988, 102
Stat. 3110.)
CODIFICATION
Section was enacted as part of the AIDS Amendments
of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health
Service Act which comprises this chapter.

§ 300ee–5. Use of funds to supply hypodermic
needles or syringes for illegal drug use; prohibition
None of the funds provided under this Act or
an amendment made by this Act shall be used to
provide individuals with hypodermic needles or
syringes so that such individuals may use illegal
drugs, unless the Surgeon General of the Public
Health Service determines that a demonstration
needle exchange program would be effective in
reducing drug abuse and the risk that the public
will become infected with the etiologic agent for
acquired immune deficiency syndrome.
(Pub. L. 100–607, title II, § 256(b), Nov. 4, 1988, 102
Stat. 3110; Pub. L. 100–690, title II, § 2602(d)(1),
Nov. 18, 1988, 102 Stat. 4234.)
REFERENCES IN TEXT
This Act, referred to in text, is Pub. L. 100–607, Nov.
4, 1988, 102 Stat. 3048, as amended, known as the
‘‘Health Omnibus Programs Extension of 1988’’. For
complete classification of this Act to the Code, see
Short Title of 1988 Amendments note set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the AIDS Amendments
of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health
Service Act which comprises this chapter.
AMENDMENTS
1988—Pub. L. 100–690 substituted ‘‘Surgeon General of
the Public Health Service’’ for ‘‘Surgeon General of the
United States’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–6. Transferred
CODIFICATION
Section, Pub. L. 100–607, title IX, § 902, Nov. 4, 1988, 102
Stat. 3171; Pub. L. 100–690, title II, § 2605(a), Nov. 18,
1988, 102 Stat. 4234, which provided for testing of State
prisoners, was renumbered section 2648 of the Public
Health Service Act by Pub. L. 101–381, title III,
§ 301(b)(1), Aug. 18, 1990, 104 Stat. 615, and transferred to
section 300ff–48 of this title, prior to repeal by Pub. L.
106–345, title III, § 301(a), Oct. 20, 2000, 114 Stat. 1345.

PART A—FORMULA GRANTS TO STATES
§ 300ee–11. Establishment of program
(a) Allotments for States
For the purpose described in subsection (b) of
this section, the Secretary shall for each of the

§ 300ee–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fiscal years 1989 through 1991 make an allotment
for each State in an amount determined in accordance with section 300ee–17 of this title. The
Secretary shall make payments each such fiscal
year to each State from the allotment for the
State if the Secretary approves for the fiscal
year involved an application submitted by the
State pursuant to section 300ee–13 of this title.
(b) Purpose of grants
The Secretary may not make payments under
subsection (a) of this section for a fiscal year
unless the State involved agrees to expend the
payments only for the purpose of carrying out,
in accordance with section 300ee–12 of this title,
public information activities with respect to acquired immune deficiency syndrome.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2501, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3093; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2501 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238
of this title.

§ 300ee–12. Provisions with respect to carrying
out purpose of grants
A State may expend payments received under
section 300ee–11(a) of this title—
(1) to develop, establish, and conduct public
information activities relating to the prevention and diagnosis of acquired immune deficiency syndrome for those populations or communities in the State in which there are a significant number of individuals at risk of infection with the etiologic agent for such syndrome;
(2) to develop, establish, and conduct such
public information activities for the general
public relating to the prevention and diagnosis
of such syndrome;
(3) to develop, establish, and conduct activities to reduce risks relating to such syndrome,
including research into the prevention of such
syndrome;
(4) to conduct demonstration projects for the
prevention of such syndrome;
(5) to provide technical assistance to public
entities, to nonprofit private entities concerned with such syndrome, to schools, and to
employers, for the purpose of developing information programs relating to such syndrome;
(6) with respect to education and training
programs for the prevention of such syndrome,
to conduct such programs for health professionals (including allied health professionals),
public safety workers (including emergency
response employees), teachers, school administrators, and other appropriate education personnel;
(7) to conduct appropriate programs for educating school-aged children with respect to
such syndrome, after consulting with local
school boards;
(8) to make available to physicians and dentists in the State information with respect to
acquired immune deficiency syndrome, including measures for the prevention of exposure

Page 1198

to, and the transmission of, the etiologic
agent for such syndrome (which information is
updated not less than annually with the most
recently available scientific date 1 relating to
such syndrome);
(9) to carry out the initial implementation
of recommendations contained in the guidelines and the model curriculum developed
under section 300ee–2 of this title; and
(10) to make grants to public entities, and to
nonprofit private entities concerned with acquired immune deficiency syndrome, for the
purpose of the development, establishment,
and expansion of programs for education directed toward individuals at increased risk of
infection with the etiologic agent for such
syndrome and activities to reduce the risks of
exposure to such etiologic agent, with preference to programs directed toward populations in which there is significant evidence
of such infection.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2502, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3094; amended Pub. L.
100–690, title II, § 2619(b), Nov. 18, 1988, 102 Stat.
4242; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
PRIOR PROVISIONS
A prior section 2502 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238a
of this title.
AMENDMENTS
1988—Par. (9). Pub. L. 100–690 made technical amendment to reference to section 300ee–2 of this title to correct reference to corresponding provision of original
act.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–13. Requirement of submission of application containing certain agreements and assurances
(a) In general
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless—
(1) the State involved submits to the Secretary a description of the purposes for which
the State intends to expend the payments for
the fiscal year;
(2) the description identifies the populations,
areas, and localities in the State with a need
for the services for which amounts may be
provided by the State under this part;
(3) the description provides information relating to the programs and activities to be
supported and services to be provided, including a description of the manner in which such
programs and activities will be coordinated
with any similar programs and activities of
public and private entities;
(4) the State submits to the Secretary an application for the payments containing agreements in accordance with this part;
1 So

in original. Probably should be ‘‘data’’.

Page 1199

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) the agreements are made through certification from the chief executive officer of the
State;
(6) with respect to such agreements, the application provides assurances of compliance
satisfactory to the Secretary; and
(7) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this part.
(b) Opportunity for public comment
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless the State involved agrees that, in developing and carrying out the description required
in subsection (a) of this section, the State will
provide public notice with respect to the description (including any revisions) and will facilitate comments from interested persons.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2503, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3095; amended Pub. L.
100–690, title II, § 2619(c), Nov. 18, 1988, 102 Stat.
4242; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
PRIOR PROVISIONS
A prior section 2503 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238b
of this title.
AMENDMENTS
1988—Subsec. (a)(3). Pub. L. 100–690 struck out ‘‘and’’
after semicolon.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–14. Restrictions on use of grant
(a) In general
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless the State involved agrees that the payments will not be expended—
(1) to provide inpatient services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve real property
(other than minor remodeling of existing improvements to real property) or to purchase
major medical equipment; or
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition
for the receipt of Federal funds.
(b) Limitation on administrative expenses
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless the State involved agrees that the State
will not expend more than 5 percent of the payments for administrative expenses with respect
to carrying out the purpose described in section
300ee–11(b) of this title.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2504, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3095; renumbered title

§ 300ee–15

XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2504 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238c
of this title.

§ 300ee–15. Requirement of reports and audits by
States
(a) Reports
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless the State involved agrees to prepare and
submit to the Secretary an annual report in
such form and containing such information as
the Secretary determines to be necessary for—
(1) securing a record and a description of the
purposes for which payments received by the
State pursuant to such section were expended
and of the recipients of such payments;
(2) determining whether the payments were
expended in accordance with the needs within
the State required to be identified pursuant to
section 300ee–13(a)(2) of this title;
(3) determining whether the payments were
expended in accordance with the purpose described in section 300ee–11(b) of this title; and
(4) determining the percentage of payments
received pursuant to such section that were
expended by the State for administrative expenses during the preceding fiscal year.
(b) Audits
(1) The Secretary may not make payments
under section 300ee–11(a) of this title for a fiscal
year unless the State involved agrees to establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the State under such section.
(2) The Secretary may not make payments
under section 300ee–11(a) of this title for a fiscal
year unless the State involved agrees that—
(A) the State will provide for—
(i) a financial and compliance audit of
such payments; or
(ii) a single financial and compliance audit
of each entity administering such payments;
(B) the audit will be performed biennially
and will cover expenditures in each fiscal year;
and
(C) the audit will be conducted in accordance
with standards established by the Comptroller
General of the United States for the audit of
governmental organizations, programs, activities, and functions.
(3) The Secretary may not make payments
under section 300ee–11(a) of this title for a fiscal
year unless the State involved agrees that, not
later than 30 days after the completion of an
audit under paragraph (2), the State will provide
a copy of the audit report to the State legislature.
(4) For purposes of paragraph (2), the term ‘‘financial and compliance audit’’ means an audit
to determine whether the financial statements
of an audited entity present fairly the financial
position, and the results of financial operations,
of the entity in accordance with generally ac-

§ 300ee–16

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cepted accounting principles, and whether the
entity has complied with laws and regulations
that may have a material effect upon the financial statements.
(c) Availability to public
The Secretary may not make payments under
section 300ee–11(a) of this title for a fiscal year
unless the State involved agrees to make copies
of the reports and audits described in this section available for public inspection.
(d) Evaluations by Comptroller General
The Comptroller General of the United States
shall, from time to time, evaluate the expenditures by States of payments received under section 300ee–11(a) of this title in order to ensure
that expenditures are consistent with the provisions of this part.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2505, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3095; amended Pub. L.
100–690, title II, § 2619(d), Nov. 18, 1988, 102 Stat.
4242; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
PRIOR PROVISIONS
A prior section 2505 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238d
of this title.
AMENDMENTS
1988—Subsec. (b)(1), (2). Pub. L. 100–690 substituted
‘‘make payments’’ for ‘‘payments’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–16. Additional required agreements
(a) In general
The Secretary may not, except as provided in
subsection (b) of this section, make payments
under section 300ee–11(a) of this title for a fiscal
year unless the State involved agrees that—
(1) all programs conducted or supported by
the State with such payments will establish
objectives for the program and will determine
the extent to which the objectives are met;
(2) information provided under this part will
be scientifically accurate and factually correct;
(3) in carrying out section 300ee–11(b) of this
title, the State will give priority to programs
described in section 300ee–12(10) of this title
for individuals described in such section;
(4) with respect to a State in which there is
a substantial number of individuals who are
intravenous substance abusers, the State will
place priority on activities under this part directed at such substance abusers;
(5) with respect to a State in which there is
a significant incidence of reported cases of acquired immune deficiency syndrome, the State
will—
(A) for the purpose described in subsection
(b) of section 300ee–11 of this title, expend
not less than 50 percent of payments received under subsection (a) of such section
for a fiscal year—

Page 1200

(i) to make grants to public entities, to
migrant health centers (as defined in section 254b(a) 1 of this title), to community
health centers (as defined in section
254c(a) 1 of this title), and to nonprofit private entities concerned with acquired immune deficiency syndrome; or
(ii) to enter into contracts with public
and private entities; and
(B) of the amounts reserved for a fiscal
year by the State for expenditures required
in subparagraph (A), expend not less than 50
percent to carry out section 300ee–12(10) of
this title through grants to nonprofit private entities, including minority entities,
concerned with acquired immune deficiency
syndrome located in and representative of
communities and subpopulations reflecting
the local incidence of such syndrome;
(6) with respect to programs carried out pursuant to section 300ee–12(10) of this title, the
State will ensure that any applicant for a
grant under such section agrees—
(A) that any educational or informational
materials developed with a grant pursuant
to such section will contain material, and be
presented in a manner, that is specifically
directed toward the group for which such
materials are intended;
(B) to provide a description of the manner
in which the applicant has planned the program in consultation with, and of the manner in which such applicant will consult during the conduct of the program with—
(i) appropriate local officials and community groups for the area to be served by
the program;
(ii) organizations comprised of, and representing, the specific population to which
the education or prevention effort is to be
directed; and
(iii) individuals having expertise in
health education and in the needs of the
population to be served;
(C) to provide information demonstrating
that the applicant has continuing relationships, or will establish continuing relationships, with a portion of the population in the
service area that is at risk of infection with
the etiologic agent for acquired immune deficiency syndrome and with public and private entities in such area that provide
health or other support services to individuals with such infection;
(D) to provide a description of—
(i) the objectives established by the applicant for the conduct of the program;
and
(ii) the methods the applicant will use to
evaluate the activities conducted under
the program to determine if such objectives are met; and
(E) such other information as the Secretary may prescribe;
(7) with respect to programs carried out pursuant to section 300ee–12(10) of this title, the
State will give preference to any applicant for
1 See

References in Text note below.

Page 1201

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300ee–17

a grant pursuant to such section that is located in, has a history of service in, and will
serve under the program, any geographic area
in which—
(A) there is a significant incidence of acquired immune deficiency syndrome;
(B) there has been a significant increase in
the incidence of such syndrome; or
(C) there is a significant risk of becoming
infected with the etiologic agent for such
syndrome;

Subsec. (b). Pub. L. 100–690, § 2619(d)(5) [(e)(5)], added
subsec. (b).

(8) the State will establish reasonable criteria to evaluate the effective performance of
entities that receive funds from payments
made to the State under section 300ee–11(a) of
this title and will establish procedures for procedural and substantive independent State review of the failure by the State to provide
funds for any such entity;
(9) the State will permit and cooperate with
Federal investigations undertaken in accordance with section 300ee–18(e) of this title;
(10) the State will maintain State expenditures for services provided pursuant to section
300ee–11 of this title at a level equal to not less
than the average level of such expenditures
maintained by the State for the 2-year period
preceding the fiscal year for which the State is
applying to receive payments.
(b) ‘‘Significant percentage’’ defined
For purposes of subsection (a)(5) of this section, the term ‘‘significant percentage’’ means
at least a percentage of 1 percent of the number
of reported cases of acquired immune deficiency
syndrome in the United States.

Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.

(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2506, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3097; amended Pub. L.
100–690, title II, § 2619(d) [(e)], Nov. 18, 1988, 102
Stat. 4243; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
REFERENCES IN TEXT
Sections 254b and 254c of this title, referred to in subsec. (a)(5)(A)(i), were in the original references to sections 329 and 330, meaning sections 329 and 330 of act
July 1, 1944, which were omitted in the general amendment of subpart I (§ 254b et seq.) of part D of subchapter
II of this chapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110
Stat. 3626. Sections 2 and 3(a) of Pub. L. 104–299 enacted
new sections 330 and 330A of act July 1, 1944, which are
classified, respectively, to sections 254b and 254c of this
title.
PRIOR PROVISIONS
A prior section 2506 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238e
of this title.
AMENDMENTS
1988—Subsec. (a). Pub. L. 100–690, § 2619(d)(1) [(e)(1)],
designated existing provisions as subsec. (a).
Subsec. (a)(5). Pub. L. 100–690, § 2619(d)(2) [(e)(2)],
struck out concluding provisions which read as follows:
‘‘(For purposes of this section, the term ‘significant
percentage’ means at least a percentage of 1 percent of
the number of reported cases of such syndrome in the
United States);’’.
Subsec. (a)(8). Pub. L. 100–690, § 2619(d)(3) [(e)(3)], substituted ‘‘funds from payments’’ for ‘‘funds from to
payments’’ and struck out ‘‘and’’ after semicolon.
Subsec. (a)(9). Pub. L. 100–690, § 2619(d)(4) [(e)(4)], substituted ‘‘section 300ee–18(e) of this title’’ for ‘‘section
300ee–19(e) of this title’’.

EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER

§ 300ee–17. Determination of amount of allotments for States
(a) Minimum allotment
Subject to the extent of amounts made available in appropriation Acts, the allotment for a
State under section 300ee–11(a) of this title for a
fiscal year shall be the greater of—
(1) the applicable amount specified in subsection (b) of this section; or
(2) the amount determined in accordance
with subsection (c) of this section.
(b) Determination of minimum allotment
(1) If the total amount appropriated under section 300ee–24(a) of this title for a fiscal year exceeds $100,000,000, the amount referred to in subsection (a)(1) of this section shall be $300,000 for
the fiscal year.
(2) If the total amount appropriated under section 300ee–24(a) of this title for a fiscal year
equals or exceeds $50,000,000, but is less than
$100,000,000, the amount referred to in subsection
(a)(1) of this section shall be $200,000 for the fiscal year.
(3) If the total amount appropriated under section 300ee–24(a) of this title for a fiscal year is
less than $50,000,000, the amount referred to in
subsection (a)(1) of this section shall be $100,000
for the fiscal year.
(c) Determination under formula
(1) The amount referred to in subsection (a)(2)
of this section is the sum of—
(A) the amount determined under paragraph
(2); and
(B) the amount determined under paragraph
(3).
(2) The amount referred to in paragraph (1)(A)
is the product of—
(A) an amount equal to 50 percent of the
amounts appropriated pursuant to section
300ee–24(a) of this title; and
(B) a percentage equal to the quotient of—
(i) the population of the State involved; divided by
(ii) the population of the United States.
(3) The amount referred to in paragraph (1)(B)
is the product of—
(A) an amount equal to 50 percent of the
amounts appropriated pursuant to section
300ee–24(a) of this title; and
(B) a percentage equal to the quotient of—
(i) the number of additional cases of acquired immune deficiency syndrome re-

§ 300ee–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ported to and confirmed by the Secretary for
the State involved for the most recent fiscal
year for which such data is available; divided by
(ii) the number of additional cases of such
syndrome reported to and confirmed by the
Secretary for the United States for such fiscal year.
(d) Disposition of certain funds appropriated for
allotments
(1) Amounts described in paragraph (2) shall be
allotted by the Secretary to States receiving
payments under section 300ee–11(a) of this title
for the fiscal year (other than any State referred
to in paragraph (2)(C)). Such amounts shall be
allotted according to a formula established by
the Secretary. The formula shall be equivalent
to the formula described in this section under
which the allotment under section 300ee–11(a) of
this title for the State for the fiscal year involved was determined.
(2) The amounts referred to in paragraph (1)
are any amounts that are not paid to States
under section 300ee–11(a) of this title as a result
of—
(A) the failure of any State to submit an application under section 300ee–13 of this title;
(B) the failure, in the determination of the
Secretary, of any State to prepare within a
reasonable period of time such application in
compliance with such section; or
(C) any State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2507, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3098; amended Pub. L.
100–690, title II, § 2619(e) [(f)], Nov. 18, 1988, 102
Stat. 4243; renumbered title XXV and amended
Pub. L. 101–93, § 5(e)(1), (2), Aug. 16, 1989, 103 Stat.
612.)
PRIOR PROVISIONS
A prior section 2507 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238f
of this title.
AMENDMENTS
1989—Subsec. (a). Pub. L. 101–93, § 5(e)(2), substituted
‘‘Subject to the extent of amounts made available in
appropriation Acts, the allotment’’ for ‘‘The allotment’’.
1988—Subsec. (a)(1). Pub. L. 100–690, § 2619(e)(1) [(f)(1)],
substituted ‘‘applicable amount specified’’ for ‘‘amount
described’’.
Subsec. (b)(1). Pub. L. 100–690, § 2619(e)(2)(A)(i)
[(f)(2)(A)(i)], made technical amendment to reference to
section 300ee–24(a) of this title to correct reference to
corresponding provision of original act.
Pub. L. 100–690, § 2619(e)(2)(A)(ii) [(f)(2)(A)(ii)], substituted ‘‘subsection (a)(1) of this section shall be’’ for
‘‘subsection (a)(1) of this section is’’.
Subsec. (b)(2), (3). Pub. L. 100–690, § 2619(e)(2)(B), (C)
[(f)(2)(B), (C)], substituted ‘‘subsection (a)(1) of this section shall be’’ for ‘‘subsection (a)(1) of this section is’’.
Subsec. (d). Pub. L. 100–690, § 2619(e)(3) [(f)(3)], substituted ‘‘allotment under section 300ee–11(a) of this
title’’ for ‘‘allotment’’ in par. (1) and ‘‘section 300ee–13
of this title’’ for ‘‘section 300ee–17 of this title’’ in par.
(2)(A).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved

Page 1202

Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–18. Failure to comply with agreements
(a) Repayment of payments
(1) The Secretary may, subject to subsection
(c) of this section, require a State to repay any
payments received by the State under section
300ee–11(a) of this title that the Secretary determines were not expended by the State in accordance with the agreements required to be contained in the application submitted by the State
pursuant to section 300ee–13 of this title.
(2) If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against the
amount of any payment due to be paid to the
State under section 300ee–11(a) of this title.
(b) Withholding of payments
(1) The Secretary may, subject to subsection
(c) of this section, withhold payments due under
section 300ee–11(a) of this title if the Secretary
determines that the State involved is not expending amounts received under such section in
accordance with the agreements required to be
contained in the application submitted by the
State pursuant to section 300ee–13 of this title.
(2) The Secretary shall cease withholding payments from a State under paragraph (1) if the
Secretary determines that there are reasonable
assurances that the State will expend amounts
received under section 300ee–11(a) of this title in
accordance with the agreements referred to in
such paragraph.
(3) The Secretary may not withhold funds
under paragraph (1) from a State for a minor
failure to comply with the agreements referred
to in such paragraph.
(c) Opportunity for hearing
Before requiring repayment of payments under
subsection (a)(1) of this section, or withholding
payments under subsection (b)(1) of this section,
the Secretary shall provide to the State an opportunity for a hearing conducted within the
State.
(d) Prompt response to serious allegations
The Secretary shall promptly respond to any
complaint of a substantial or serious nature
that a State has failed to expend amounts received under section 300ee–11(a) of this title in
accordance with the agreements required to be
contained in the application submitted by the
State pursuant to section 300ee–13 of this title.
(e) Investigations
(1) The Secretary shall conduct in several
States in each fiscal year investigations of the
expenditure of payments received by the States
under section 300ee–11(a) of this title in order to
evaluate compliance with the agreements required to be contained in the applications submitted to the Secretary pursuant to section
300ee–13 of this title.
(2) The Comptroller General of the United
States may conduct investigations of the expenditure of funds received under section
300ee–11(a) of this title by a State in order to ensure compliance with the agreements referred to
in paragraph (1).

Page 1203

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Each State, and each entity receiving funds
from payments made to a State under section
300ee–11(a) of this title, shall make appropriate
books, documents, papers, and records available
to the Secretary and the Comptroller General of
the United States, or any of their duly authorized representatives, for examination, copying,
or mechanical reproduction on or off the premises of the appropriate entity upon a reasonable
request therefor.
(4)(A) In conducting any investigation in a
State, the Secretary and the Comptroller General of the United States may not make a request for any information not readily available
to the State, or to an entity receiving funds
from payments made to the State under section
300ee–11(a) of this title, or make an unreasonable request for information to be compiled, collected, or transmitted in any form not readily
available.
(B) Subparagraph (A) shall not apply to the
collection, compilation, or transmittal of data
in the course of a judicial proceeding.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2508, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3099; amended Pub. L.
100–690, title II, § 2619(f) [(g)], Nov. 18, 1988, 102
Stat. 4243; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
PRIOR PROVISIONS
A prior section 2508 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238g
of this title.
AMENDMENTS
1988—Subsec. (a). Pub. L. 100–690, § 2619(f)(1) [(g)(1)],
substituted ‘‘300ee–13 of this title’’ for ‘‘300ee–17 of this
title’’.
Subsec. (b). Pub. L. 100–690, § 2619(f)(2) [(g)(2)], inserted
‘‘of payments’’ after ‘‘Withholding’’ in heading and substituted ‘‘300ee–13 of this title’’ for ‘‘300ee–17 of this
title’’ in par. (1).
Subsecs. (d), (e)(1). Pub. L. 100–690, § 2619(f)(3), (4)
[(g)(3), (4)], substituted ‘‘300ee–13 of this title’’ for
‘‘300ee–17 of this title’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–19. Prohibition
statements

against

certain

false

(a) In general
(1) A person may not knowingly make or cause
to be made any false statement or representation of a material fact in connection with the
furnishing of items or services for which
amounts may be paid by a State from payments
received by the State under section 300ee–11(a)
of this title.
(2) A person with knowledge of the occurrence
of any event affecting the right of the person to
receive any amounts from payments made to
the State under section 300ee–11(a) of this title
may not conceal or fail to disclose any such
event with the intent of fraudulently securing
such amounts.
(b) Criminal penalty for violation of prohibition
Any person who violates a prohibition established in subsection (a) of this section may for

§ 300ee–21

each violation be fined in accordance with title
18, or imprisoned for not more than 5 years, or
both.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2509, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3101; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2509 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238h
of this title.

§ 300ee–20. Technical assistance and provision by
Secretary of supplies and services in lieu of
grant funds
(a) Technical assistance
The Secretary may provide training and technical assistance to States with respect to the
planning, development, and operation of any
program or service carried out pursuant to this
part. The Secretary may provide such technical
assistance directly or through grants or contracts.
(b) Provision by Secretary of supplies and services in lieu of grant funds
(1) Upon the request of a State receiving payments under this part, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the
State in carrying out such part and, for such
purpose, may detail to the State any officer or
employee of the Department of Health and
Human Services.
(2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount
of payments under section 300ee–11(a) of this
title to the State by an amount equal to the
costs of detailing personnel and the fair market
value of any supplies, equipment, or services
provided by the Secretary. The Secretary shall,
for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2510, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3101; amended Pub. L.
100–690, title II, § 2619(g) [(h)], Nov. 18, 1988, 102
Stat. 4243; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
PRIOR PROVISIONS
A prior section 2510 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238i
of this title.
AMENDMENTS
1988—Subsec. (b)(2). Pub. L. 100–690 substituted ‘‘section 300ee–11(a) of this title’’ for ‘‘the program involved’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–21. Evaluations
The Secretary shall, directly or through
grants or contracts, evaluate the services pro-

§ 300ee–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

vided and activities carried out with payments
to States under this part.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2511, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3101; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2511 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238j
of this title.

§ 300ee–22. Report by Secretary
The Secretary shall annually prepare a report
on the activities of the States carried out pursuant to this part. Such report may include any
recommendations of the Secretary for appropriate administrative and legislative initiatives.
The report shall be submitted to the Congress
through inclusion in the comprehensive report
required in section 300cc(a) 1 of this title.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2512, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3101; amended Pub. L.
100–690, title II, § 2619(h) [(i)], Nov. 18, 1988, 102
Stat. 4243; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
REFERENCES IN TEXT
Section 300cc of this title, referred to in text, was repealed by Pub. L. 109–482, title I, § 104(b)(2)(C), Jan. 15,
2007, 120 Stat. 3693.
PRIOR PROVISIONS
A prior section 2512 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238k
of this title.
AMENDMENTS
1988—Pub. L. 100–690 substituted ‘‘section 300cc(a)’’
for ‘‘section 300cc’’.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

§ 300ee–23. Definition
For purposes of this part, the term ‘‘infection
with the etiologic agent for acquired immune
deficiency syndrome’’ includes any condition
arising from such etiologic agent.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2513, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3102; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2513 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238l
of this title.

§ 300ee–24. Funding
(a) Authorization of appropriations
For the purpose of making allotments under
section 300ee–11(a) of this title, there are author1 See

References in Text note below.

Page 1204

ized to be appropriated $165,000,000 for fiscal year
1989 and such sums as may be necessary for each
of the fiscal years 1990 and 1991.
(b) Availability to States
Any amounts paid to a State under section
300ee–11(a) of this title shall remain available to
the State until the expiration of the 1-year period beginning on the date on which the State
receives such amounts.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2514, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3102; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
PRIOR PROVISIONS
A prior section 2514 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238m
of this title.

PART B—NATIONAL INFORMATION PROGRAMS
§ 300ee–31. Availability of information to general
public
(a) Comprehensive information plan
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall annually prepare a comprehensive plan, including a budget, for a National Acquired Immune Deficiency Syndrome Information Program. The plan shall contain provisions to implement the provisions of this subchapter. The
Director shall submit such plan to the Secretary. The authority established in this subsection may not be construed to be the exclusive
authority for the Director to carry out information activities with respect to acquired immune
deficiency syndrome.
(b) Clearinghouse
(1) The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may establish a clearinghouse to make information concerning acquired immune deficiency syndrome available to Federal agencies,
States, public and private entities, and the general public.
(2) The clearinghouse may conduct or support
programs—
(A) to develop and obtain educational materials, model curricula, and methods directed
toward reducing the transmission of the etiologic agent for acquired immune deficiency
syndrome;
(B) to provide instruction and support for individuals who provide instruction in methods
and techniques of education relating to the
prevention of acquired immune deficiency syndrome and instruction in the use of the materials and curricula described in subparagraph
(A); and
(C) to conduct, or to provide for the conduct
of, the materials, curricula, and methods described in paragraph (1) and the efficacy of
such materials, curricula, and methods in preventing infection with the the 1 etiologic agent
for acquired immune deficiency syndrome.
(c) Toll-free telephone communications
The Secretary shall provide for the establishment and maintenance of toll-free telephone
1 So

in original.

Page 1205

TITLE 42—THE PUBLIC HEALTH AND WELFARE

communications to provide information to, and
respond to queries from, the public concerning
acquired immune deficiency syndrome. Such
communications shall be available on a 24-hour
basis.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2521, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3102; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612; amended Pub. L. 102–531, title III,
§ 312(d)(22), Oct. 27, 1992, 106 Stat. 3505.)
AMENDMENTS
1992—Subsecs. (a), (b)(1). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.

§ 300ee–32. Public information campaigns
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
may make grants to public entities, and to nonprofit private entities concerned with acquired
immune deficiency syndrome, and shall enter
into contracts with public and private entities,
for the development and delivery of public service announcements and paid advertising messages that warn individuals about activities
which place them at risk of infection with the
etiologic agent for such syndrome.
(b) Requirement of application
The Secretary may not provide financial assistance under subsection (a) of this section unless—
(1) an application for such assistance is submitted to the Secretary;
(2) with respect to carrying out the purpose
for which the assistance is to be provided, the
application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as
the Secretary determines to be necessary to
carry out this section.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2522, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3103; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612; amended Pub. L. 102–531, title III,
§ 312(d)(23), Oct. 27, 1992, 106 Stat. 3505.)
AMENDMENTS
1992—Subsec. (a). Pub. L. 102–531 substituted ‘‘Centers
for Disease Control and Prevention’’ for ‘‘Centers for
Disease Control’’.

§ 300ee–33. Provision of information to underserved populations
(a) In general
The Secretary may make grants to public entities, to migrant health centers (as defined in
section 254b(a) 1 of this title), to community
health centers (as defined in section 254c(a) 1 of
this title), and to nonprofit private entities concerned with acquired immune deficiency syndrome, for the purpose of assisting grantees in
1 See

References in Text note below.

§ 300ee–34

providing services to populations of individuals
that are underserved with respect to programs
providing information on the prevention of exposure to, and the transmission of, the etiologic
agent for acquired immune deficiency syndrome.
(b) Preferences in making grants
In making grants under subsection (a) of this
section, the Secretary shall give preference to
any applicant for such a grant that has the ability to disseminate rapidly the information described in subsection (a) of this section (including any national organization with such ability).
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2523, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3103; renumbered title
XXV, Pub. L. 101–93, § 5(e)(1), Aug. 16, 1989, 103
Stat. 612.)
REFERENCES IN TEXT
Sections 254b and 254c of this title, referred to in subsec. (a), were in the original references to sections 329
and 330, meaning sections 329 and 330 of act July 1, 1944,
which were omitted in the general amendment of subpart I (§ 254b et seq.) of part D of subchapter II of this
chapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat.
3626. Sections 2 and 3(a) of Pub. L. 104–299 enacted new
sections 330 and 330A of act July 1, 1944, which are classified, respectively, to sections 254b and 254c of this
title.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.

§ 300ee–34. Authorization of appropriations
(a) In general
For the purpose of carrying out sections
300ee–31 through 300ee–33 of this title, there are
authorized to be appropriated $105,000,000 for fiscal year 1989 and such sums as may be necessary
for each of the fiscal years 1990 and 1991.
(b) Allocations
(1) Of the amounts appropriated pursuant to
subsection (a) of this section, the Secretary
shall make available $45,000,000 to carry out section 300ee–32 of this title and $30,000,000 to carry
out this part through financial assistance to minority entities for the provision of services to
minority populations.
(2) After consultation with the Director of the
Office of Minority Health and with the Indian
Health Service, the Secretary, acting through
the Director of the Centers for Disease Control
and Prevention, shall, not later than 90 days
after November 4, 1988, publish guidelines to provide procedures for applications for funding pursuant to paragraph (1) and for public comment.
(July 1, 1944, ch. 373, title XXV, formerly title
XV, § 2524, as added Pub. L. 100–607, title II, § 221,
Nov. 4, 1988, 102 Stat. 3103; amended Pub. L.
100–690, title II, § 2619(i) [(j)], Nov. 18, 1988, 102
Stat. 4244; renumbered title XXV, Pub. L. 101–93,
§ 5(e)(1), Aug. 16, 1989, 103 Stat. 612; Pub. L.
102–531, title III, § 312(d)(24), Oct. 27, 1992, 106
Stat. 3505.)

§ 300ff

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1206

AMENDMENTS

CODIFICATION

1992—Subsec. (b)(2). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’.
1988—Subsec. (b)(2). Pub. L. 100–690 substituted ‘‘the
date of the enactment of the AIDS Amendments of
1988’’ for ‘‘the date of the enactment of this section’’,
which for purposes of codification was translated as
‘‘November 4, 1988’’.

Section was enacted as part of the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and
not as part of the Public Health Service Act which
comprises this chapter.

PART A—EMERGENCY RELIEF FOR AREAS WITH
SUBSTANTIAL NEED FOR SERVICES
SUBPART I—GENERAL GRANT PROVISIONS

EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–690 effective immediately
after enactment of Pub. L. 100–607, which was approved
Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out
as a note under section 242m of this title.

SUBCHAPTER XXIV—HIV HEALTH CARE
SERVICES PROGRAM
§ 300ff. Purpose
It is the purpose of this Act to provide emergency assistance to localities that are disproportionately affected by the Human Immunodeficiency Virus epidemic and to make financial
assistance available to States and other public
or private nonprofit entities to provide for the
development, organization, coordination and operation of more effective and cost efficient systems for the delivery of essential services to individuals and families with HIV disease.
(Pub. L. 101–381, § 2, Aug. 18, 1990, 104 Stat. 576.)
REFERENCES IN TEXT
This Act, referred to in text, is Pub. L. 101–381, Aug.
18, 1990, 104 Stat. 576, known as the Ryan White Comprehensive AIDS Resources Emergency Act of 1990,
which enacted this subchapter, transferred section
300ee–6 of this title to section 300ff–48 of this title,
amended sections 284a, 286, 287a, 287c–2, 289f, 290aa–3a,
299c–5, 300ff–48, and 300aaa to 300aaa–13 [now 238 to
238m] of this title, and enacted provisions set out as
notes under sections 201, 300x–4, 300ff–11, 300ff–46, and
300ff–80 of this title. For complete classification of this
Act to the Code, see Short Title of 1990 Amendment
note set out under section 201 of this title and Tables.
CODIFICATION
Section was enacted as part of the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and
not as part of the Public Health Service Act which
comprises this chapter.

§ 300ff–1. Prohibition on use of funds
None of the funds made available under this
Act, or an amendment made by this Act, shall
be used to provide individuals with hypodermic
needles or syringes so that such individuals may
use illegal drugs.
(Pub. L. 101–381, title IV, § 422, Aug. 18, 1990, 104
Stat. 628.)
REFERENCES IN TEXT
This Act, referred to in text, is Pub. L. 101–381, Aug.
18, 1990, 104 Stat. 576, known as the Ryan White Comprehensive AIDS Resources Emergency Act of 1990,
which enacted this subchapter, transferred section
300ee–6 of this title to section 300ff–48 of this title,
amended sections 284a, 286, 287a, 287c–2, 289f, 290aa–3a,
299c–5, 300ff–48, and 300aaa to 300aaa–13 [now 238 to
238m] of this title, and enacted provisions set out as
notes under sections 201, 300x–4, 300ff–11, 300ff–46, and
300ff–80 of this title. For complete classification of this
Act to the Code, see Short Title of 1990 Amendment
note set out under section 201 of this title and Tables.

§ 300ff–11. Establishment of program of grants
(a) Eligible areas
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall, subject to subsections (b)
through (c) of this section, make grants in accordance with section 300ff–13 of this title for
the purpose of assisting in the provision of the
services specified in section 300ff–14 of this title
in any metropolitan area for which there has
been reported to and confirmed by the Director
of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases
of AIDS during the most recent period of 5 calendar years for which such data are available.
(b) Continued status as eligible area
Notwithstanding any other provision of this
section, a metropolitan area that is an eligible
area for a fiscal year continues to be an eligible
area until the metropolitan area fails, for three
consecutive fiscal years—
(1) to meet the requirements of subsection
(a); and
(2) to have a cumulative total of 3,000 or
more living cases of AIDS (reported to and
confirmed by the Director of the Centers for
Disease Control and Prevention) as of December 31 of the most recent calendar year for
which such data is available.
(c) Boundaries
For purposes of determining eligibility under
this subpart—
(1) with respect to a metropolitan area that
received funding under this subpart in fiscal
year 2006, the boundaries of such metropolitan
area shall be the boundaries that were in effect for such area for fiscal year 1994; or
(2) with respect to a metropolitan area that
becomes eligible to receive funding under this
subpart in any fiscal year after fiscal year
2006, the boundaries of such metropolitan area
shall be the boundaries that are in effect for
such area when such area initially receives
funding under this subpart.
(July 1, 1944, ch. 373, title XXVI, § 2601, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 576; amended Pub. L. 102–531, title III,
§ 312(d)(25), Oct. 27, 1992, 106 Stat. 3505; Pub. L.
104–146, §§ 3(a)(1), (2), 12(c)(1), May 20, 1996, 110
Stat. 1346, 1373; Pub. L. 109–415, title I, §§ 101(a),
(b), 106(a), 107(b), title VII, §§ 702(1), 703, Dec. 19,
2006, 120 Stat. 2768, 2780, 2783, 2819, 2820; Pub. L.
111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
PRIOR PROVISIONS
A prior section 2601 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238 of this title.

Page 1207

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a). Pub. L. 109–415, § 702(1), substituted
‘‘AIDS’’ for ‘‘acquired immune deficiency syndrome’’.
Pub. L. 109–415, § 106(a), substituted ‘‘during the most
recent period’’ for ‘‘for the most recent period’’.
Pub. L. 109–415, § 101(b), substituted ‘‘through (c)’’ for
‘‘through (d)’’ and inserted ‘‘and confirmed by’’ after
‘‘reported to’’.
Subsecs. (b) to (d). Pub. L. 109–415, §§ 101(a), 107(b),
added subsecs. (b) and (c), substituted ‘‘this subpart’’
for ‘‘this part’’ in subsec. (c) wherever appearing, and
struck out former subsecs. (b) to (d) which related to
requirement regarding confirmation of cases, requirements regarding population, and continued status as eligible area, respectively.
1996—Subsec. (a). Pub. L. 104–146, § 12(c)(1), inserted
‘‘section’’ before ‘‘300ff–14’’.
Pub. L. 104–146, § 3(a)(1)(B), substituted ‘‘metropolitan
area for which there has been reported to the Director
of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases of acquired immune deficiency syndrome for the most recent period
of 5 calendar years for which such data are available.’’
for ‘‘metropolitan area for which, as of June 30, 1990, in
the case of grants for fiscal year 1991, and as of March
31 of the most recent fiscal year for which such data is
available in the case of a grant for any subsequent fiscal year—
‘‘(1) there has been reported to and confirmed by
the Director of the Centers for Disease Control and
Prevention a cumulative total of more than 2,000
cases of acquired immune deficiency syndrome; or
‘‘(2) the per capita incidence of cumulative cases of
such syndrome (computed on the basis of the most recently available data on the population of the area)
is not less than 0.0025.’’
Pub. L. 104–146, § 3(a)(1)(A), substituted ‘‘subject to
subsections (b) through (d)’’ for ‘‘subject to subsection
(b)’’.
Subsecs. (c), (d). Pub. L. 104–146, § 3(a)(2), added subsecs. (c) and (d).
1992—Subsecs. (a)(1), (b). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
Pub. L. 111–87, § 2(a)(2), (3), Oct. 30, 2009, 123 Stat. 2885,
provided that:
‘‘(2) EFFECTIVE DATE.—Paragraph (1) [repealing section 703 of Pub. L. 109–415, formerly set out as an Effective Date of Repeal note below] shall take effect as if
enacted on September 30, 2009.
‘‘(3) CONTINGENCY PROVISIONS.—Notwithstanding section 703 of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Public Law 109–415; 120 Stat. 2767
[2820]) [repealing this subchapter, formerly set out as
an Effective Date of Repeal note below] and section 139
of the Continuing Appropriations Resolution, 2010 [123
Stat. 2048]—
‘‘(A) the provisions of title XXVI of the Public
Health Service Act (42 U.S.C. 300ff et seq.), as in effect on September 30, 2009, are hereby revived; and
‘‘(B) the amendments made by this Act to title
XXVI of the Public Health Service Act (42 U.S.C. 300ff
et seq.) [see Tables for classification] shall apply to
such title as so revived and shall take effect as if enacted on September 30, 2009.’’
EFFECTIVE DATE OF REPEAL
Pub. L. 109–415, title VII, § 703, Dec. 19, 2006, 120 Stat.
2820, which provided for the repeal of this subchapter

§ 300ff–12

effective Oct. 1, 2009, was itself repealed by Pub. L.
111–87, § 2(a)(1), Oct. 30, 2009, 123 Stat. 2885.
EFFECTIVE DATE OF 1996 AMENDMENT
Section 13 of Pub. L. 104–146 provided that:
‘‘(a) IN GENERAL.—Except as provided in subsection
(b), this Act [enacting sections 300ff–27a, 300ff–31,
300ff–33 to 300ff–37, 300ff–77, 300ff–78, and 300ff–101 of this
title, amending this section and sections 294n, 300d,
300ff–12 to 300ff–17, 300ff–21 to 300ff–23, 300ff–26 to
300ff–29, 300ff–47 to 300ff–49, 300ff–51, 300ff–52, 300ff–54,
300ff–55, 300ff–64, 300ff–71, 300ff–74, 300ff–76, and 300ff–84
of this title, transferring section 294n of this title to
section 300ff–111 of this title, repealing sections 300ff–18
and 300ff–30 of this title, and enacting provisions set
out as notes under sections 201, 300cc, and 300ff–33 of
this title and section 4103 of Title 5, Government Organization and Employees], and the amendments made by
this Act, shall become effective on October 1, 1996.
‘‘(b) EXCEPTION.—The amendments made by sections
3(a), 5, 6, and 7 of this Act to sections 2601(c), 2601(d),
2603(a), 2618(b), 2626, 2677, and 2691 of the Public Health
Service Act [sections 300ff–11(c), (d), 300ff–13(a),
300ff–28(b), 300ff–34, 300ff–77, and 300ff–101 of this title],
shall become effective on the date of enactment of this
Act [May 20, 1996].’’
STUDIES BY INSTITUTE OF MEDICINE
Pub. L. 106–345, title V, § 501, Oct. 20, 2000, 114 Stat.
1352, required the Secretary of Health and Human Services to request the Institute of Medicine or another appropriate entity to conduct a study of State surveillance systems on the prevalence of HIV and a study
concerning the relationship between epidemiological
measures and health care for certain individuals with
HIV and to ensure that the former study be completed
and a report submitted to congressional committees
not later than 3 years after Oct. 20, 2000, and that the
latter study be completed and a report submitted to
congressional committees not later than 2 years after
Oct. 20, 2000.
STUDY REGARDING HIV DISEASE IN RURAL AREAS
Pub. L. 101–381, title IV, § 403, Aug. 18, 1990, 104 Stat.
622 directed Secretary of Health and Human Services,
after consultation with Director of the Office of Rural
Health Policy, to conduct study for purpose of estimating incidence and prevalence in rural areas of cases of
acquired immune deficiency syndrome and cases of infection with etiologic agent for such syndrome and determine adequacy in rural areas of services for diagnosing and providing treatment for such cases that are in
early stages of infection, and provided that, not later
than 1 year after Aug. 18, 1990, Secretary was to submit
report to Congress.

§ 300ff–12. Administration and planning council
(a) Administration
(1) In general
Assistance made available under grants
awarded under this subpart shall be directed
to the chief elected official of the city or
urban county that administers the public
health agency that provides outpatient and
ambulatory services to the greatest number of
individuals with AIDS, as reported to and confirmed by the Centers for Disease Control and
Prevention, in the eligible area that is awarded such a grant.
(2) Requirements
(A) In general
To receive assistance under section
300ff–11(a) of this title, the chief elected official of the eligible area involved shall—

§ 300ff–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) establish, through intergovernmental
agreements with the chief elected officials
of the political subdivisions described in
subparagraph (B), an administrative mechanism to allocate funds and services based
on—
(I) the number of AIDS cases in such
subdivisions;
(II) the severity of need for outpatient
and ambulatory care services in such
subdivisions; and
(III) the health and support services
personnel needs of such subdivisions; and
(ii) establish an HIV health services
planning council in accordance with subsection (b) of this section.
(B) Local political subdivision
The political subdivisions referred to in
subparagraph (A) are those political subdivisions in the eligible area—
(i) that provide HIV-related health services; and
(ii) for which the number of cases reported for purposes of section 300ff–11(a) of
this title constitutes not less than 10 percent of the number of such cases reported
for the eligible area.
(b) HIV health services planning council
(1) Establishment
To be eligible for assistance under this subpart, the chief elected official described in
subsection (a)(1) of this section shall establish
or designate an HIV health services planning
council that shall reflect in its composition
the demographics of the population of individuals with HIV/AIDS in the eligible area involved, with particular consideration given to
disproportionately affected and historically
underserved groups and subpopulations. Nominations for membership on the council shall be
identified through an open process and candidates shall be selected based on locally delineated and publicized criteria. Such criteria
shall include a conflict-of-interest standard
that is in accordance with paragraph (5).
(2) Representation
The HIV health services planning council
shall include representatives of—
(A) health care providers, including federally qualified health centers;
(B) community-based organizations serving affected populations and AIDS service
organizations;
(C) social service providers, including providers of housing and homeless services;
(D) mental health and substance abuse
providers;
(E) local public health agencies;
(F) hospital planning agencies or health
care planning agencies;
(G) affected communities, including people
with HIV/AIDS, members of a Federally recognized Indian tribe as represented in the
population, individuals co-infected with hepatitis B or C and historically underserved
groups and subpopulations;
(H) nonelected community leaders;
(I) State government (including the State
medicaid agency and the agency administer-

Page 1208

ing the program under part B of this subchapter);
(J) grantees under subpart II 1 of part C of
this subchapter;
(K) grantees under section 300ff–71 of this
title, or, if none are operating in the area,
representatives of organizations with a history of serving children, youth, women, and
families living with HIV and operating in
the area;
(L) grantees under other Federal HIV programs, including but not limited to providers of HIV prevention services; and
(M) representatives of individuals who formerly were Federal, State, or local prisoners, were released from the custody of the
penal system during the preceding 3 years,
and had HIV/AIDS as of the date on which
the individuals were so released.
(3) Method of providing for council
(A) In general
In providing for a council for purposes of
paragraph (1), a chief elected official receiving a grant under section 300ff–11(a) of this
title may establish the council directly or
designate an existing entity to serve as the
council, subject to subparagraph (B).
(B) Consideration regarding designation of
council
In making a determination of whether to
establish or designate a council under subparagraph (A), a chief elected official receiving a grant under section 300ff–11(a) of this
title shall give priority to the designation of
an existing entity that has demonstrated experience in planning for the HIV health care
service needs within the eligible area and in
the implementation of such plans in addressing those needs. Any existing entity so designated shall be expanded to include a broad
representation of the full range of entities
that provide such services within the geographic area to be served.
(4) Duties
The planning council established or designated under paragraph (1) shall—
(A) determine the size and demographics of
the population of individuals with HIV/
AIDS, as well as the size and demographics
of the estimated population of individuals
with HIV/AIDS who are unaware of their
HIV status;
(B) determine the needs of such population, with particular attention to—
(i) individuals with HIV/AIDS who know
their HIV status and are not receiving
HIV-related services;
(ii) disparities in access and services
among affected subpopulations and historically underserved communities; and
(iii) individuals with HIV/AIDS who do
not know their HIV status;
(C) establish priorities for the allocation of
funds within the eligible area, including how
best to meet each such priority and additional factors that a grantee should consider
1 See

References in Text note below.

Page 1209

TITLE 42—THE PUBLIC HEALTH AND WELFARE

in allocating funds under a grant based on
the—
(i) size and demographics of the population of individuals with HIV/AIDS (as determined under subparagraph (A)) and the
needs of such population (as determined
under subparagraph (B));
(ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of
proposed strategies and interventions, to
the extent that data are reasonably available;
(iii) priorities of the communities with
HIV/AIDS for whom the services are intended;
(iv) coordination in the provision of services to such individuals with programs for
HIV prevention and for the prevention and
treatment of substance abuse, including
programs that provide comprehensive
treatment for such abuse;
(v) availability of other governmental
and non-governmental resources, including
the State medicaid plan under title XIX of
the Social Security Act [42 U.S.C. 1396 et
seq.] and the State Children’s Health Insurance Program under title XXI of such
Act [42 U.S.C. 1397aa et seq.] to cover
health care costs of eligible individuals
and families with HIV/AIDS; and
(vi) capacity development needs resulting from disparities in the availability of
HIV-related services in historically underserved communities;
(D) develop a comprehensive plan for the
organization and delivery of health and support services described in section 300ff–14 of
this title that—
(i) includes a strategy for identifying individuals who know their HIV status and
are not receiving such services and for informing the individuals of and enabling
the individuals to utilize the services, giving particular attention to eliminating
disparities in access and services among
affected subpopulations and historically
underserved communities, and including
discrete goals, a timetable, and an appropriate allocation of funds;
(ii) includes a strategy to coordinate the
provision of such services with programs
for HIV prevention (including outreach
and early intervention) and for the prevention and treatment of substance abuse (including programs that provide comprehensive treatment services for such abuse);
(iii) is compatible with any State or
local plan for the provision of services to
individuals with HIV/AIDS; and
(iv) includes a strategy, coordinated as
appropriate with other community strategies and efforts, including discrete goals, a
timetable, and appropriate funding, for
identifying individuals with HIV/AIDS who
do not know their HIV status, making
such individuals aware of such status, and
enabling such individuals to use the health
and support services described in section
300ff–14 of this title, with particular attention to reducing barriers to routine testing
and disparities in access and services

§ 300ff–12

among affected subpopulations and historically underserved communities;
(E) assess the efficiency of the administrative mechanism in rapidly allocating funds
to the areas of greatest need within the eligible area, and at the discretion of the planning council, assess the effectiveness, either
directly or through contractual arrangements, of the services offered in meeting the
identified needs;
(F) participate in the development of the
statewide coordinated statement of need initiated by the State public health agency responsible for administering grants under
part B of this subchapter;
(G) establish methods for obtaining input
on community needs and priorities which
may include public meetings (in accordance
with paragraph (7)), conducting focus groups,
and convening ad-hoc panels; and
(H) coordinate with Federal grantees that
provide HIV-related services within the eligible area.
(5) Conflicts of interest
(A) In general
The planning council under paragraph (1)
may not be directly involved in the administration of a grant under section 300ff–11(a) of
this title. With respect to compliance with
the preceding sentence, the planning council
may not designate (or otherwise be involved
in the selection of) particular entities as recipients of any of the amounts provided in
the grant.
(B) Required agreements
An individual may serve on the planning
council under paragraph (1) only if the individual agrees that if the individual has a financial interest in an entity, if the individual is an employee of a public or private entity, or if the individual is a member of a
public or private organization, and such entity or organization is seeking amounts
from a grant under section 300ff–11(a) of this
title, the individual will not, with respect to
the purpose for which the entity seeks such
amounts, participate (directly or in an advisory capacity) in the process of selecting entities to receive such amounts for such purpose.
(C) Composition of council
The following applies regarding the membership of a planning council under paragraph (1):
(i) Not less than 33 percent of the council
shall be individuals who are receiving HIVrelated services pursuant to a grant under
section 300ff–11(a) of this title, are not officers, employees, or consultants to any entity that receives amounts from such a
grant, and do not represent any such entity, and reflect the demographics of the
population of individuals with HIV/AIDS
as determined under paragraph (4)(A). For
purposes of the preceding sentence, an individual shall be considered to be receiving
such services if the individual is a parent
of, or a caregiver for, a minor child who is
receiving such services.

§ 300ff–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) With respect to membership on the
planning council, clause (i) may not be
construed as having any effect on entities
that receive funds from grants under any
of parts B through F of this subchapter but
do not receive funds from grants under section 300ff–11(a) of this title, on officers or
employees of such entities, or on individuals who represent such entities.
(6) Grievance procedures
A planning council under paragraph (1) shall
develop procedures for addressing grievances
with respect to funding under this subpart, including procedures for submitting grievances
that cannot be resolved to binding arbitration.
Such procedures shall be described in the bylaws of the planning council and be consistent
with the requirements of subsection (c) of this
section.
(7) Public deliberations
With respect to a planning council under
paragraph (1), the following applies:
(A) The council may not be chaired solely
by an employee of the grantee under section
300ff–11(a) of this title.
(B) In accordance with criteria established
by the Secretary:
(i) The meetings of the council shall be
open to the public and shall be held only
after adequate notice to the public.
(ii) The records, reports, transcripts,
minutes, agenda, or other documents
which were made available to or prepared
for or by the council shall be available for
public inspection and copying at a single
location.
(iii) Detailed minutes of each meeting of
the council shall be kept. The accuracy of
all minutes shall be certified to by the
chair of the council.
(iv) This subparagraph does not apply to
any disclosure of information of a personal
nature that would constitute a clearly unwarranted invasion of personal privacy, including any disclosure of medical information or personnel matters.
(c) Grievance procedures
(1) Federal responsibility
(A) Models
The Secretary shall, through a process
that includes consultations with grantees
under this subpart and public and private experts in grievance procedures, arbitration,
and mediation, develop model grievance procedures that may be implemented by the
planning council under subsection (b)(1) of
this section and grantees under this subpart.
Such model procedures shall describe the
elements that must be addressed in establishing local grievance procedures and provide grantees with flexibility in the design
of such local procedures.
(B) Review
The Secretary shall review grievance procedures established by the planning council
and grantees under this subpart to determine if such procedures are adequate. In
making such a determination, the Secretary

Page 1210

shall assess whether such procedures permit
legitimate grievances to be filed, evaluated,
and resolved at the local level.
(2) Grantees
To be eligible to receive funds under this
subpart, a grantee shall develop grievance procedures that are determined by the Secretary
to be consistent with the model procedures developed under paragraph (1)(A). Such procedures shall include a process for submitting
grievances to binding arbitration.
(d) Process for establishing allocation priorities
Promptly after the date of the submission of
the report required in section 501(b) of the Ryan
White CARE Act Amendments of 2000 (relating
to the relationship between epidemiological
measures and health care for certain individuals
with HIV/AIDS), the Secretary, in consultation
with planning councils and entities that receive
amounts from grants under section 300ff–11(a) or
300ff–21 of this title, shall develop epidemiologic
measures—
(1) for establishing the number of individuals
living with HIV/AIDS who are not receiving
HIV-related health services; and
(2) for carrying out the duties under subsection (b)(4) of this section and section
300ff–27(b) of this title.
(e) Training guidance and materials
The Secretary shall provide to each chief
elected official receiving a grant under section
300ff–11(a) of this title guidelines and materials
for training members of the planning council
under paragraph (1) regarding the duties of the
council.
(July 1, 1944, ch. 373, title XXVI, § 2602, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 577; amended Pub. L. 102–531, title III,
§ 312(d)(26), Oct. 27, 1992, 106 Stat. 3505; Pub. L.
104–146, § 3(b)(1), May 20, 1996, 110 Stat. 1347; Pub.
L. 106–345, title I, §§ 101–102(c), 103, Oct. 20, 2000,
114 Stat. 1320–1323; Pub. L. 109–415, title I,
§§ 106(b), 107(b), title VII, §§ 702(3), 703, Dec. 19,
2006, 120 Stat. 2780, 2783, 2820; Pub. L. 111–87,
§§ 2(a)(1), (3)(A), 6(a), Oct. 30, 2009, 123 Stat. 2885,
2891.)
REFERENCES IN TEXT
Subpart II of part C of this subchapter, referred to in
subsec. (b)(2)(J), was redesignated subpart I of part C of
this subchapter by Pub. L. 106–345, title III, § 301(b)(1),
Oct. 20, 2000, 114 Stat. 1345, and is classified to section
300ff–51 et seq. of this title.
The Social Security Act, referred to in subsec.
(b)(4)(C)(v), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.
Titles XIX and XXI of the Act are classified generally
to subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.
Section 501 of the Ryan White CARE Act Amendments of 2000, referred to in subsec. (d), is section 501
of Pub. L. 106–345, which is set out as a note under section 300ff–11 of this title. Provisions relating to a report
are contained in section 501(d) of Pub. L. 106–345.
PRIOR PROVISIONS
A prior section 2602 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238a of this title.

Page 1211

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (b)(4)(A). Pub. L. 111–87, § 6(a)(1), inserted
‘‘, as well as the size and demographics of the estimated population of individuals with HIV/AIDS who
are unaware of their HIV status’’ before semicolon.
Subsec. (b)(4)(B)(iii). Pub. L. 111–87, § 6(a)(2), added cl.
(iii).
Subsec. (b)(4)(D)(iv). Pub. L. 111–87, § 6(a)(3), added cl.
(iv).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ wherever appearing.
Pub. L. 109–415, § 107(b), substituted ‘‘this subpart’’ for
‘‘this part’’ wherever appearing.
Subsec. (b)(2)(G). Pub. L. 109–415, § 106(b), inserted
‘‘, members of a Federally recognized Indian tribe as
represented in the population, individuals co-infected
with hepatitis B or C’’ before ‘‘and historically underserved groups’’.
2000—Subsec. (b)(1). Pub. L. 106–345, § 101(a)(1), substituted ‘‘demographics of the population of individuals
with HIV disease in the eligible area involved,’’ for ‘‘demographics of the epidemic in the eligible area involved,’’.
Subsec. (b)(2)(C). Pub. L. 106–345, § 101(a)(2)(A), inserted before semicolon at end ‘‘, including providers of
housing and homeless services’’.
Subsec. (b)(2)(G). Pub. L. 106–345, § 101(a)(2)(B), struck
out ‘‘or AIDS’’ after ‘‘HIV disease’’.
Subsec. (b)(2)(K). Pub. L. 106–345, § 101(a)(2)(C), struck
out ‘‘and’’ after semicolon.
Subsec. (b)(2)(L). Pub. L. 106–345, § 101(a)(2)(D), substituted ‘‘, including but not limited to providers of
HIV prevention services; and’’ for period at end.
Subsec. (b)(2)(M). Pub. L. 106–345, § 101(a)(2)(E), added
subpar. (M).
Subsec. (b)(3)(C). Pub. L. 106–345, § 103(1), struck out
heading and text of subpar. (C). Text read as follows:
‘‘A planning council may not be chaired solely by an
employee of the grantee.’’
Subsec. (b)(4)(A), (B). Pub. L. 106–345, § 102(a)(2), added
subpars. (A) and (B). Former subpars. (A) and (B) redesignated (C) and (D), respectively.
Subsec. (b)(4)(C). Pub. L. 106–345, § 102(a)(1), redesignated subpar. (A) as (C). Former subpar. (C) redesignated (E).
Subsec. (b)(4)(C)(i) to (vi). Pub. L. 106–345, § 102(a)(3),
added cls. (i) to (vi) and struck out former cls. (i) to (iv)
which read as follows:
‘‘(i) documented needs of the HIV-infected population;
‘‘(ii) cost and outcome effectiveness of proposed
strategies and interventions, to the extent that such
data are reasonably available (either demonstrated or
probable);
‘‘(iii) priorities of the HIV-infected communities for
whom the services are intended; and
‘‘(iv) availability of other governmental and nongovernmental resources;’’.
Subsec. (b)(4)(D). Pub. L. 106–345, § 102(a)(4), amended
subpar. (D) generally. Prior to amendment, subpar. (D)
read as follows: ‘‘develop a comprehensive plan for the
organization and delivery of health services described
in section 300ff–14 of this title that is compatible with
any existing State or local plan regarding the provision
of health services to individuals with HIV disease;’’.
Pub. L. 106–345, § 102(a)(1), redesignated subpar. (B) as
(D). Former subpar. (D) redesignated (F).
Subsec. (b)(4)(E), (F). Pub. L. 106–345, § 102(a)(1), redesignated subpars. (C) and (D) as (E) and (F), respectively.
Former subpar. (E) redesignated (G).
Subsec. (b)(4)(G). Pub. L. 106–345, § 102(a)(1), (6)(A), redesignated subpar. (E) as (G) and substituted ‘‘public

§ 300ff–12

meetings (in accordance with paragraph (7)),’’ for ‘‘public meetings,’’.
Subsec. (b)(4)(H). Pub. L. 106–345, § 102(a)(5), (6)(B), (7),
added subpar. (H).
Subsec. (b)(5)(C). Pub. L. 106–345, § 101(b), added subpar. (C).
Subsec. (b)(7). Pub. L. 106–345, § 103(2), added par. (7).
Subsec. (d). Pub. L. 106–345, § 102(b), added subsec. (d).
Subsec. (e). Pub. L. 106–345, § 102(c), added subsec. (e).
1996—Subsec. (b)(1). Pub. L. 104–146, § 3(b)(1)(A)(ii), inserted at end ‘‘Nominations for membership on the
council shall be identified through an open process and
candidates shall be selected based on locally delineated
and publicized criteria. Such criteria shall include a
conflict-of-interest standard that is in accordance with
paragraph (5).’’
Pub. L. 104–146, § 3(b)(1)(A)(i), substituted ‘‘reflect in
its composition the demographics of the epidemic in
the eligible area involved, with particular consideration given to disproportionately affected and historically underserved groups and subpopulations.’’ for ‘‘include representatives of—
‘‘(A) health care providers;
‘‘(B) community-based and AIDS service organizations;
‘‘(C) social service providers;
‘‘(D) mental health care providers;
‘‘(E) local public health agencies;
‘‘(F) hospital planning agencies or health care planning agencies;
‘‘(G) affected communities, including individuals
with HIV disease;
‘‘(H) non-elected community leaders;
‘‘(I) State government;
‘‘(J) grantees under subpart II of part C of this subchapter; and
‘‘(K) the lead agency of any Health Resources and
Services Administration adult and pediatric HIV-related care demonstration project operating in the
area to be served.’’
Subsec. (b)(2). Pub. L. 104–146, § 3(b)(1)(E), added par.
(2). Former par. (2) redesignated (3).
Subsec. (b)(2)(C). Pub. L. 104–146, § 3(b)(1)(B), added
subpar. (C).
Subsec. (b)(3). Pub. L. 104–146, § 3(b)(1)(D), redesignated par. (2) as (3). Former par. (3) redesignated (4).
Subsec. (b)(3)(A). Pub. L. 104–146, § 3(b)(1)(C)(i), substituted ‘‘area, including how best to meet each such
priority and additional factors that a grantee should
consider in allocating funds under a grant based on
the—’’ for ‘‘area;’’ and added cls. (i) to (iv).
Subsec. (b)(3)(B). Pub. L. 104–146, § 3(b)(1)(C)(ii),
struck out ‘‘and’’ at end.
Subsec. (b)(3)(C). Pub. L. 104–146, § 3(b)(1)(C)(iii), substituted ‘‘, and at the discretion of the planning council, assess the effectiveness, either directly or through
contractual arrangements, of the services offered in
meeting the identified needs;’’ for period at end.
Subsec. (b)(3)(D), (E). Pub. L. 104–146, § 3(b)(1)(C)(iv),
added subpars. (D) and (E).
Subsec. (b)(4). Pub. L. 104–146, § 3(b)(1)(D), redesignated par. (3) as (4).
Subsec. (b)(5), (6). Pub. L. 104–146, § 3(b)(1)(F), added
pars. (5) and (6).
Subsec. (c). Pub. L. 104–146, § 3(b)(1)(F), added subsec.
(c).
1992—Subsec. (a)(1). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 6(a) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.

§ 300ff–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–345, title VI, § 601, Oct. 20, 2000, 114 Stat.
1355, provided that: ‘‘This Act [see section 1 of Pub. L.
106–345, set out as a Short Title of 2000 Amendments
note under section 201 of this title] and the amendments made by this Act take effect October 1, 2000, or
upon the date of the enactment of this Act [Oct. 20,
2000], whichever occurs later.’’
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–13. Type and distribution of grants
(a) Grants based on relative need of area
(1) In general
In carrying out section 300ff–11(a) of this
title, the Secretary shall make a grant for
each eligible area for which an application
under section 300ff–15(a) of this title has been
approved. Each such grant shall be made in an
amount determined in accordance with paragraph (3).
(2) Expedited distribution
Not later than 60 days after an appropriation
becomes available to carry out this subpart
for a fiscal year, the Secretary shall, except in
the case of waivers granted under section
300ff–15(c) 1 of this title, disburse 662⁄3 percent
of the amount made available under section
300ff–20(b) of this title for carrying out this
subpart for such fiscal year through grants to
eligible areas under section 300ff–11(a) of this
title, in accordance with paragraphs (3) and
(4).
(3) Amount of grant
(A) In general
Subject to the extent of amounts made
available in appropriations Acts, a grant
made for purposes of this paragraph to an eligible area shall be made in an amount equal
to the product of—
(i) an amount equal to the amount available for distribution under paragraph (2)
for the fiscal year involved; and
(ii) the percentage constituted by the
ratio of the distribution factor for the eligible area to the sum of the respective distribution factors for all eligible areas;
which product shall then, as applicable, be
increased under paragraph (4).
(B) Distribution factor
For purposes of subparagraph (A)(ii), the
term ‘‘distribution factor’’ means an amount
equal to the living cases of HIV/AIDS (reported to and confirmed by the Director of
the Centers for Disease Control and Prevention) in the eligible area involved, as determined under subparagraph (C).
(C) Living cases of HIV/AIDS
(i) Requirement of names-based reporting
Except as provided in clause (ii), the
number determined under this subparagraph for an eligible area for a fiscal year
1 See

References in Text note below.

Page 1212

for purposes of subparagraph (B) is the
number of living names-based cases of
HIV/AIDS that, as of December 31 of the
most recent calendar year for which such
data is available, have been reported to
and confirmed by the Director of the Centers for Disease Control and Prevention.
(ii) Transition period; exemption regarding
non-AIDS cases
For each of the fiscal years 2007 through
2012, an eligible area is, subject to clauses
(iii) through (v), exempt from the requirement under clause (i) that living namesbased non-AIDS cases of HIV be reported
unless—
(I) a system was in operation as of December 31, 2005, that provides sufficiently accurate and reliable namesbased reporting of such cases throughout
the State in which the area is located,
subject to clause (viii); or
(II) no later than the beginning of fiscal year 2008 or a subsequent fiscal year
through fiscal year 2012, the Secretary,
in consultation with the chief executive
of the State in which the area is located,
determines that a system has become
operational in the State that provides
sufficiently accurate and reliable namesbased reporting of such cases throughout
the State.
(iii) Requirements for exemption for fiscal
year 2007
For fiscal year 2007, an exemption under
clause (ii) for an eligible area applies only
if, by October 1, 2006—
(I)(aa) the State in which the area is
located had submitted to the Secretary a
plan for making the transition to sufficiently accurate and reliable namesbased reporting of living non-AIDS cases
of HIV; or
(bb) all statutory changes necessary to
provide for sufficiently accurate and reliable reporting of such cases had been
made; and
(II) the State had agreed that, by April
1, 2008, the State will begin accurate and
reliable names-based reporting of such
cases, except that such agreement is not
required to provide that, as of such date,
the system for such reporting be fully
sufficient with respect to accuracy and
reliability throughout the area.
(iv) Requirement for exemption as of fiscal
year 2008
For each of the fiscal years 2008 through
2012, an exemption under clause (ii) for an
eligible area applies only if, as of April 1,
2008, the State in which the area is located
is substantially in compliance with the
agreement under clause (iii)(II).
(v) Progress toward names-based reporting
For fiscal year 2009 or a subsequent fiscal
year, the Secretary may terminate an exemption under clause (ii) for an eligible
area if the State in which the area is located submitted a plan under clause

Page 1213

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iii)(I)(aa) and the Secretary determines
that the State is not substantially following the plan.
(vi) Counting of cases in areas with exemptions
(I) In general
With respect to an eligible area that is
under a reporting system for living nonAIDS cases of HIV that is not namesbased (referred to in this subparagraph
as ‘‘code-based reporting’’), the Secretary shall, for purposes of this subparagraph, modify the number of such
cases reported for the eligible area in
order to adjust for duplicative reporting
in and among systems that use codebased reporting.
(II) Adjustment rate
The adjustment rate under subclause
(I) for an eligible area shall be a reduction of 5 percent for fiscal years before
fiscal year 2012 (and 6 percent for fiscal
year 2012) in the number of living nonAIDS cases of HIV reported for the area.
(III) Increased adjustment for certain
areas previously using code-based reporting
For purposes of this subparagraph for
each of fiscal years 2010 through 2012, the
Secretary shall deem the applicable
number of living cases of HIV/AIDS in an
area that were reported to and confirmed
by the Centers for Disease Control and
Prevention to be 3 percent higher than
the actual number if—
(aa) for fiscal year 2007, such area
was a transitional area;
(bb) fiscal year 2007 was the first year
in which the count of living non-AIDS
cases of HIV in such area, for purposes
of this section, was based on a namesbased reporting system; and
(cc) the amount of funding that such
area received under this part for fiscal
year 2007 was less than 70 percent of
the amount of funding (exclusive of
funds that were identified as being for
purposes of the Minority AIDS Initiative) that such area received under
such part for fiscal year 2006.
(vii) Multiple political jurisdictions
With respect to living non-AIDS cases of
HIV, if an eligible area is not entirely
within one political jurisdiction and as a
result is subject to more than one reporting system for purposes of this subparagraph:
(I) Names-based reporting under clause
(i) applies in a jurisdictional portion of
the area, or an exemption under clause
(ii) applies in such portion (subject to
applicable provisions of this subparagraph), according to whether namesbased reporting or code-based reporting
is used in such portion.
(II) If under subclause (I) both namesbased reporting and code-based reporting
apply in the area, the number of code-

§ 300ff–13

based cases shall be reduced under clause
(vi).
(viii) List of eligible areas meeting standard regarding December 31, 2005
(I) In general
If an eligible area or portion thereof is
in a State specified in subclause (II), the
eligible area or portion shall be considered to meet the standard described in
clause (ii)(I). No other eligible area or
portion thereof may be considered to
meet such standard.
(II) Relevant States
For purposes of subclause (I), the
States specified in this subclause are the
following: Alaska, Alabama, Arkansas,
Arizona, Colorado, Florida, Indiana,
Iowa, Idaho, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi,
North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New
York, Nevada, Ohio, Oklahoma, South
Carolina, South Dakota, Tennessee,
Texas, Utah, Virginia, Wisconsin, West
Virginia, Wyoming, Guam, and the Virgin Islands.
(ix) Rules of construction regarding acceptance of reports
(I) Cases of AIDS
With respect to an eligible area that is
subject to the requirement under clause
(i) and is not in compliance with the requirement for names-based reporting of
living non-AIDS cases of HIV, the Secretary shall, notwithstanding such noncompliance, accept reports of living
cases of AIDS that are in accordance
with such clause.
(II) Applicability of exemption requirements
The provisions of clauses (ii) through
(viii) may not be construed as having
any legal effect for fiscal year 2013 or
any subsequent fiscal year, and accordingly, the status of a State for purposes
of such clauses may not be considered
after fiscal year 2012.
(x) Program for detecting inaccurate or
fraudulent counting
The Secretary shall carry out a program
to monitor the reporting of names-based
cases for purposes of this subparagraph
and to detect instances of inaccurate reporting, including fraudulent reporting.
(xi) Future fiscal years
For fiscal years beginning with fiscal
year 2013, determinations under this paragraph shall be based only on living namesbased cases of HIV/AIDS with respect to
the area involved.
(D) Code-based areas; limitation on increase
in grant
(i) In general
For each of the fiscal years 2007 through
2012, if code-based reporting (within the

§ 300ff–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

meaning of subparagraph (C)(vi)) applies in
an eligible area or any portion thereof as
of the beginning of the fiscal year involved, then notwithstanding any other
provision of this paragraph, the amount of
the grant pursuant to this paragraph for
such area for such fiscal year may not—
(I) for fiscal year 2007, exceed by more
than 5 percent the amount of the grant
for the area that would have been made
pursuant to this paragraph and paragraph (4) for fiscal year 2006 (as such
paragraphs were in effect for such fiscal
year) if paragraph (2) (as so in effect) had
been applied by substituting ‘‘662⁄3 percent’’ for ‘‘50 percent’’; and
(II) for each of the fiscal years 2008
through 2012, exceed by more than 5 percent the amount of the grant pursuant
to this paragraph and paragraph (4) for
the area for the preceding fiscal year.
(ii) Use of amounts involved
For each of the fiscal years 2007 through
2012, amounts available as a result of the
limitation under clause (i) shall be made
available by the Secretary as additional
amounts for grants pursuant to subsection
(b) for the fiscal year involved, subject to
paragraph (4) and section 300ff–20(d)(2) of
this title.
(4) Increases in grant
(A) In general
For each eligible area that received a
grant pursuant to this subsection for fiscal
year 2009, the Secretary shall, for each of the
fiscal years 2010 through 2013, increase the
amount of the grant made pursuant to paragraph (3) for the area to ensure that the
amount of the grant for the fiscal year involved is not less than the following amount,
as applicable to such fiscal year:
(i) For fiscal year 2010, an amount equal
to 95 percent of the sum of the amount of
the grant made pursuant to paragraph (3)
and this paragraph for fiscal year 2009.
(ii) For each of the fiscal years 2011 and
2012, an amount equal to 100 percent of the
amount of the grant made pursuant to
paragraph (3) and this paragraph for fiscal
year 2010.
(iii) For fiscal year 2013, an amount
equal to 92.5 percent of the amount of the
grant made pursuant to paragraph (3) and
this paragraph for fiscal year 2012.
(B) Source of funds for increase
(i) In general
From the amounts available for carrying
out the single program referred to in section 300ff–19(d)(2)(C) of this title for a fiscal year (relating to supplemental grants),
the Secretary shall make available such
amounts as may be necessary to comply
with subparagraph (A), subject to section
300ff–20(d)(2) of this title.
(ii) Pro rata reduction
If the amounts referred to in clause (i)
for a fiscal year are insufficient to fully
comply with subparagraph (A) for the

Page 1214

year, the Secretary, in order to provide the
additional funds necessary for such compliance, shall reduce on a pro rata basis
the amount of each grant pursuant to this
subsection for the fiscal year, other than
grants for eligible areas for which increases under subparagraph (A) apply. A
reduction under the preceding sentence
may not be made in an amount that would
result in the eligible area involved becoming eligible for such an increase.
(C) Limitation
This paragraph may not be construed as
having any applicability after fiscal year
2013.
(b) Supplemental grants
(1) In general
Subject to subsection (a)(4)(B)(i) and section
300ff–20(d) of this title, the Secretary shall disburse the remainder of amounts not disbursed
under subsection (a)(2) of this section for such
fiscal year for the purpose of making grants
under section 300ff–11(a) of this title to eligible
areas
whose
application
under
section
300ff–15(b) of this title—
(A) contains a report concerning the dissemination of emergency relief funds under
subsection (a) of this section and the plan
for utilization of such funds;
(B) demonstrates the need in such area, on
an objective and quantified basis, for supplemental financial assistance to combat the
HIV epidemic;
(C) demonstrates the existing commitment
of local resources of the area, both financial
and in-kind, to combating the HIV epidemic;
(D) demonstrates the ability of the area to
utilize such supplemental financial resources in a manner that is immediately responsive and cost effective;
(E) demonstrates that resources will be allocated in accordance with the local demographic incidence of AIDS including appropriate allocations for services for infants,
children, youth, women, and families with
HIV/AIDS;
(F) demonstrates the inclusiveness of affected communities and individuals with
HIV/AIDS;
(G) demonstrates the manner in which the
proposed services are consistent with the
local needs assessment and the statewide
coordinated statement of need;
(H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most recent grant year
under subsection (a) for which data is available, more than 5 percent of grant funds
under such subsection canceled, offset under
subsection (c)(4), or covered by any waivers
under subsection (c)(3); and
(I) demonstrates success in identifying individuals with HIV/AIDS as described in
clauses (i) through (iii) of paragraph (2)(A).
(2) Amount of grant
(A) In general
The amount of each grant made for purposes of this subsection shall be determined

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

by the Secretary based on a weighting of
factors under paragraph (1), with demonstrated need under subparagraph (B) of
such paragraph counting one-third, and demonstrated success in identifying individuals
with HIV/AIDS who do not know their HIV
status and making them aware of such
status counting one-third. In making such
determination, the Secretary shall consider—
(i) the number of individuals who have
been tested for HIV/AIDS;
(ii) of those individuals described in
clause (i), the number of individuals who
tested for HIV/AIDS who are made aware
of their status, including the number who
test positive; and
(iii) of those individuals described in
clause (ii), the number who have been referred to appropriate treatment and care.
(B) Demonstrated need
The factors considered by the Secretary in
determining whether an eligible area has a
demonstrated need for purposes of paragraph
(1)(B) may include any or all of the following:
(i) The unmet need for such services, as
determined under section 300ff–12(b)(4) of
this title or other community input process
as
defined
under
section
300ff–19(d)(1)(A) of this title.
(ii) An increasing need for HIV/AIDS-related services, including relative rates of
increase in the number of cases of HIV/
AIDS.
(iii) The relative rates of increase in the
number of cases of HIV/AIDS within new
or emerging subpopulations.
(iv) The current prevalence of HIV/AIDS.
(v) Relevant factors related to the cost
and complexity of delivering health care
to individuals with HIV/AIDS in the eligible area.
(vi) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.
(vii) The prevalence of homelessness.
(viii) The prevalence of individuals described under section 300ff–12(b)(2)(M) of
this title.
(ix) The relevant factors that limit access to health care, including geographic
variation, adequacy of health insurance
coverage, and language barriers.
(x) The impact of a decline in the
amount received pursuant to subsection
(a) on services available to all individuals
with HIV/AIDS identified and eligible
under this subchapter.
(C) Priority in making grants
The Secretary shall provide funds under
this subsection to an eligible area to address
the decline or disruption of all EMA-provided services related to the decline in the
amounts received pursuant to subsection (a)
consistent with the grant award for the eligible area for fiscal year 2006, to the extent
that the factor under subparagraph (B)(x)
(relating to a decline in funding) applies to
the eligible area.

§ 300ff–13

(D) Increased adjustment for certain areas
previously using code-based reporting
For purposes of this subsection for each of
fiscal years 2010 through 2012, the Secretary
shall deem the applicable number of living
cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for
Disease Control and Prevention to be 3 percent higher than the actual number if the
conditions described in items (aa) through
(cc) of subsection (a)(3)(C)(vi)(III) are all satisfied.
(3) Remainder of amounts
In determining the amount of funds to be obligated under paragraph (1), the Secretary
shall include amounts that are not paid to the
eligible areas under expedited procedures
under subsection (a)(2) of this section as a result of—
(A) the failure of any eligible area to submit an application under section 300ff–15(c) 1
of this title; or
(B) any eligible area informing the Secretary that such eligible area does not intend to expend the full amount of its grant
under such section.
(4) Failure to submit
(A) In general
The failure of an eligible area to submit an
application for an expedited grant under
subsection (a)(2) of this section shall not result in such area being ineligible for a grant
under this subsection.
(B) Application
The application of an eligible area submitted under section 300ff–15(b) of this title
shall contain the assurances required under
subsection (a) of such section if such eligible
area fails to submit an application for an expedited grant under subsection (a)(2) of this
section.
(c) Timeframe for obligation and expenditure of
grant funds
(1) Obligation by end of grant year
Effective for fiscal year 2007 and subsequent
fiscal years, funds from a grant award made
pursuant to subsection (a) or (b) for a fiscal
year are available for obligation by the eligible area involved through the end of the oneyear period beginning on the date in such fiscal year on which funds from the award first
become available to the area (referred to in
this subsection as the ‘‘grant year for the
award’’), except as provided in paragraph
(3)(A).
(2) Supplemental grants; cancellation of unobligated balance of grant award
Effective for fiscal year 2007 and subsequent
fiscal years, if a grant award made pursuant to
subsection (b) for an eligible area for a fiscal
year has an unobligated balance as of the end
of the grant year for the award—
(A) the Secretary shall cancel that unobligated balance of the award, and shall require
the eligible area to return any amounts from
such balance that have been disbursed to the
area; and

§ 300ff–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) the funds involved shall be made available by the Secretary as additional amounts
for grants pursuant to subsection (b) for the
first fiscal year beginning after the fiscal
year in which the Secretary obtains the information necessary for determining that
the balance is required under subparagraph
(A) to be canceled, except that the availability of the funds for such grants is subject to
subsection (a)(4) and section 300ff–20(d)(2) of
this title as applied for such year.
(3) Formula grants; cancellation of unobligated
balance of grant award; waiver permitting
carryover
(A) In general
Effective for fiscal year 2007 and subsequent fiscal years, if a grant award made
pursuant to subsection (a) for an eligible
area for a fiscal year has an unobligated balance as of the end of the grant year for the
award, the Secretary shall cancel that unobligated balance of the award, and shall require the eligible area to return any
amounts from such balance that have been
disbursed to the area, unless—
(i) before the end of the grant year, the
chief elected official of the area submits to
the Secretary a written application for a
waiver of the cancellation, which application includes a description of the purposes
for which the area intends to expend the
funds involved; and
(ii) the Secretary approves the waiver.
(B) Expenditure by end of carryover year
With respect to a waiver under subparagraph (A) that is approved for a balance that
is unobligated as of the end of a grant year
for an award:
(i) The unobligated funds are available
for expenditure by the eligible area involved for the one-year period beginning
upon the expiration of the grant year (referred to in this subsection as the ‘‘carryover year’’).
(ii) If the funds are not expended by the
end of the carryover year, the Secretary
shall cancel that unexpended balance of
the award, and shall require the eligible
area to return any amounts from such balance that have been disbursed to the area.
(C) Use of cancelled balances
In the case of any balance of a grant award
that is cancelled under subparagraph (A) or
(B)(ii), the grant funds involved shall be
made available by the Secretary as additional amounts for grants pursuant to subsection (b) for the first fiscal year beginning
after the fiscal year in which the Secretary
obtains the information necessary for determining that the balance is required under
such subparagraph to be canceled, except
that the availability of the funds for such
grants is subject to subsection (a)(4) and section 300ff–20(d)(2) of this title as applied for
such year.
(D) Corresponding reduction in future grant
(i) In general
In the case of an eligible area for which
a balance from a grant award under sub-

Page 1216

section (a) is unobligated as of the end of
the grant year for the award—
(I) the Secretary shall reduce, by the
same amount as such unobligated balance (less any amount of such balance
that is the subject of a waiver of cancellation under subparagraph (A)), the
amount of the grant under such subsection for the first fiscal year beginning
after the fiscal year in which the Secretary obtains the information necessary
for determining that such balance was
unobligated as of the end of the grant
year (which requirement for a reduction
applies without regard to whether a
waiver under subparagraph (A) has been
approved with respect to such balance);
and
(II) the grant funds involved in such reduction shall be made available by the
Secretary as additional funds for grants
pursuant to subsection (b) for such first
fiscal year, subject to subsection (a)(4)
and section 300ff–20(d)(2) of this title;
except that this clause does not apply to
the eligible area if the amount of the unobligated balance was 5 percent or less.
(ii) Relation to increases in grant
A reduction under clause (i) for an eligible area for a fiscal year may not be taken
into account in applying subsection (a)(4)
with respect to the area for the subsequent
fiscal year.
(4) Authority regarding administration of provisions
In administering paragraphs (2) and (3) with
respect to the unobligated balance of an eligible area, the Secretary may elect to reduce
the amount of future grants to the area under
subsection (a) or (b), as applicable, by the
amount of any such unobligated balance in
lieu of cancelling such amount as provided for
in paragraph (2) or (3)(A). In such case, the
Secretary may permit the area to use such unobligated balance for purposes of any such future grant. An amount equal to such reduction
shall be available for use as additional
amounts for grants pursuant to subsection (b),
subject to subsection (a)(4) and section
300ff–20(d)(2) of this title. Nothing in this paragraph shall be construed to affect the authority of the Secretary under paragraphs (2) and
(3), including the authority to grant waivers
under paragraph (3)(A). The reduction in future grants authorized under this paragraph
shall be notwithstanding the penalty required
under paragraph (3)(D) with respect to unobligated funds.
(d) Compliance with priorities of HIV planning
council
Notwithstanding any other provision of this
subpart, the Secretary, in carrying out section
300ff–11(a) of this title, may not make any grant
under subsection (a) or (b) of this section to an
eligible area unless the application submitted by
such area under section 300ff–15 of this title for
the grant involved demonstrates that the grants
made under subsections (a) and (b) of this section to the area for the preceding fiscal year (if

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

any) were expended in accordance with the priorities applicable to such year that were established, pursuant to section 300ff–12(b)(4)(C) of
this title, by the planning council serving the
area.
(e) Report on the awarding of supplemental
funds
Not later than 45 days after the awarding of
supplemental funds under this section, the Secretary shall submit to Congress a report concerning such funds. Such report shall include information detailing—
(1) the total amount of supplemental funds
available under this section for the year involved;
(2) the amount of supplemental funds used in
accordance with the hold harmless provisions
of subsection (a)(4);
(3) the amount of supplemental funds disbursed pursuant to subsection (b)(2)(C);
(4) the disbursement of the remainder of the
supplemental funds after taking into account
the uses described in paragraphs (2) and (3);
and
(5) the rationale used for the amount of
funds disbursed as described under paragraphs
(2), (3), and (4).
(July 1, 1944, ch. 373, title XXVI, § 2603, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 578; amended Pub. L. 101–502, § 6(a), Nov. 3,
1990, 104 Stat. 1289; Pub. L. 102–531, title III,
§ 312(d)(27), Oct. 27, 1992, 106 Stat. 3506; Pub. L.
104–146, §§ 3(b)(2), (3), 4, 6(c)(1), 12(c)(2), May 20,
1996, 110 Stat. 1349, 1350, 1364, 1367, 1373; Pub. L.
106–345, title I, §§ 102(d), 111, 112, Oct. 20, 2000, 114
Stat. 1323, 1326; Pub. L. 109–415, title I, §§ 102–104,
107(b), title VII, §§ 702(3), 703, Dec. 19, 2006, 120
Stat. 2768–2774, 2783, 2820; Pub. L. 111–87,
§§ 2(a)(1), (3)(A), 3(a), 5(a), 6(b), 7(a), 8(a)(1),
(b)(1)(A), (2)(A), (C), (c)(1), Oct. 30, 2009, 123 Stat.
2885, 2888, 2890, 2892–2894.)
REFERENCES IN TEXT
Section 300ff–15 of this title, referred to in subsecs.
(a)(2) and (b)(3)(A), was amended by Pub. L. 104–146,
§ 3(b)(5)(C), (D), May 20, 1996, 110 Stat. 1353, to add a new
subsec. (c), relating to single application and grant
awards, and redesignate former subsec. (c), relating to
date for submission of grant applications, as (d).
PRIOR PROVISIONS
A prior section 2603 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238b of this title.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009; Revival of Section note
below.
Subsec. (a)(3)(C)(ii). Pub. L. 111–87, § 3(a)(1)(A)(i), substituted ‘‘2012’’ for ‘‘2009’’ in introductory provisions.
Subsec. (a)(3)(C)(ii)(II). Pub. L. 111–87, § 3(a)(1)(A)(ii),
substituted ‘‘or a subsequent fiscal year through fiscal
year 2012’’ for ‘‘or 2009’’.
Subsec. (a)(3)(C)(iv). Pub. L. 111–87, § 3(a)(1)(B), substituted ‘‘2012’’ for ‘‘2010’’.
Subsec. (a)(3)(C)(v). Pub. L. 111–87, § 3(a)(1)(C), inserted ‘‘or a subsequent fiscal year’’ after ‘‘2009’’.
Subsec. (a)(3)(C)(vi)(II). Pub. L. 111–87, § 3(a)(1)(D), inserted ‘‘for fiscal years before fiscal year 2012 (and 6
percent for fiscal year 2012)’’ after ‘‘5 percent’’.

§ 300ff–13

Subsec. (a)(3)(C)(vi)(III). Pub. L. 111–87, § 7(a)(1), added
subcl. (III).
Subsec. (a)(3)(C)(ix)(II). Pub. L. 111–87, § 3(a)(1)(E),
substituted ‘‘2013’’ for ‘‘2010’’ and ‘‘2012’’ for ‘‘2009’’.
Subsec. (a)(3)(C)(xi). Pub. L. 111–87, § 3(a)(1)(F), added
cl. (xi).
Subsec. (a)(3)(D)(i). Pub. L. 111–87, § 3(a)(2)(A)(i), substituted ‘‘2012’’ for ‘‘2009’’ in introductory provisions.
Subsec. (a)(3)(D)(i)(II). Pub. L. 111–87, § 3(a)(2)(A)(ii),
substituted ‘‘through 2012’’ for ‘‘and 2009’’.
Subsec. (a)(3)(D)(ii). Pub. L. 111–87, § 3(a)(2)(B), substituted ‘‘2012’’ for ‘‘2009’’.
Subsec. (a)(4)(A). Pub. L. 111–87, § 5(a)(1), (2), substituted ‘‘2009’’ for ‘‘2006’’ and ‘‘2010 through 2013’’ for
‘‘2007 through 2009’’ in introductory provisions, added
cls. (i) to (iii), and struck out former cls. (i) and (ii)
which read as follows:
‘‘(i) For fiscal year 2007, an amount equal to 95 percent of the amount of the grant that would have been
made pursuant to paragraph (3) and this paragraph for
fiscal year 2006 (as such paragraphs were in effect for
such fiscal year) if paragraph (2) (as so in effect) had
been applied by substituting ‘662⁄3 percent’ for ‘50 percent’.
‘‘(ii) For each of the fiscal years 2008 and 2009, an
amount equal to 100 percent of the amount of the grant
made pursuant to paragraph (3) and this paragraph for
fiscal year 2007.’’
Subsec. (a)(4)(C). Pub. L. 111–87, § 5(a)(3), substituted
‘‘2013’’ for ‘‘2009’’.
Subsec. (b)(1)(H). Pub. L. 111–87, § 8(a)(1), (b)(2)(C),
substituted ‘‘5 percent’’ for ‘‘2 percent’’ and ‘‘canceled,
offset under subsection (c)(4),’’ for ‘‘canceled’’.
Subsec. (b)(1)(I). Pub. L. 111–87, § 6(b)(1), added subpar.
(I).
Subsec. (b)(2)(A). Pub. L. 111–87, § 6(b)(2), substituted
‘‘one-third, and demonstrated success in identifying individuals with HIV/AIDS who do not know their HIV
status and making them aware of such status counting
one-third. In making such determination, the Secretary shall consider—’’ for ‘‘one-third.’’ and added cls.
(i) to (iii).
Subsec. (b)(2)(D). Pub. L. 111–87, § 7(a)(2), added subpar. (D).
Subsec. (c)(3)(D)(i). Pub. L. 111–87, § 8(b)(1)(A), substituted ‘‘5 percent’’ for ‘‘2 percent’’ in concluding provisions.
Subsec. (c)(3)(D)(i)(I). Pub. L. 111–87, § 8(c)(1), inserted
‘‘(less any amount of such balance that is the subject
of a waiver of cancellation under subparagraph (A))’’
after ‘‘unobligated balance’’.
Subsec. (c)(4). Pub. L. 111–87, § 8(b)(2)(A), added par.
(4).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a)(2). Pub. L. 109–415, § 107(b), substituted
‘‘this subpart’’ for ‘‘this part’’.
Pub. L. 109–415, § 102(a), substituted ‘‘662⁄3 percent of
the amount made available under section 300ff–20(b) of
this title for carrying out this subpart’’ for ‘‘50 percent
of the amount appropriated under section 300ff–77 of
this title’’ and ‘‘paragraphs (3) and (4)’’ for ‘‘paragraph
(3)’’ in first sentence and struck out last sentence
which read as follows: ‘‘The Secretary shall reserve an
additional percentage of the amount appropriated
under section 300ff–77 of this title for a fiscal year for
grants under this part to make grants to eligible areas
under section 300ff–11(a) of this title in accordance with
paragraph (4).’’
Subsec. (a)(3)(A). Pub. L. 109–415, § 102(d)(1), inserted
concluding provisions.
Subsec. (a)(3)(B). Pub. L. 109–415, § 102(b)(1), which directed the substitution of ‘‘living cases of HIV/AIDS
(reported to and confirmed by the Director of the Centers for Disease Control and Prevention)’’ for ‘‘estimated living cases of acquired immune deficiency syndrome’’, was executed by making the substitution for
‘‘estimated number of living cases of acquired immune
deficiency syndrome’’, to reflect the probable intent of
Congress.

§ 300ff–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a)(3)(C) to (E). Pub. L. 109–415, § 102(b)(2), (c),
added subpars. (C) and (D) and struck out former subpars. (C) to (E) which related to estimate of living
cases, determination of Secretary regarding data on
HIV cases, and unexpended funds, respectively.
Subsec. (a)(4). Pub. L. 109–415, § 102(d)(2), reenacted
heading without change and amended text generally,
substituting provisions relating to increases in grant
for each of the fiscal years 2007 through 2009 for provisions relating to increases in grant for the first
through fifth or subsequent fiscal years in a protection
period.
Subsec. (b)(1). Pub. L. 109–415, § 103(1)(A), in introductory provisions, substituted ‘‘Subject to subsection
(a)(4)(B)(i) and section 300ff–20(d) of this title, the Secretary shall’’ for ‘‘Not later than 150 days after the date
on which appropriations are made under section 300ff–77
of this title for a fiscal year, the Secretary shall’’.
Subsec. (b)(1)(B). Pub. L. 109–415, § 103(1)(B), substituted ‘‘demonstrates the need in such area, on an objective and quantified basis,’’ for ‘‘demonstrates the severe need in such area’’.
Subsec. (b)(1)(E). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Subsec. (b)(1)(F). Pub. L. 109–415, § 103(1)(C), added
subpar. (F) and struck out former subpar. (F) which
read as follows: ‘‘demonstrates the inclusiveness of the
planning council membership, with particular emphasis
on affected communities and individuals with HIV disease; and’’.
Subsec. (b)(1)(H). Pub. L. 109–415, § 103(1)(D), (E), added
subpar. (H).
Subsec. (b)(2)(A). Pub. L. 109–415, § 103(2)(A), substituted ‘‘demonstrated need’’ for ‘‘severe need’’.
Subsec. (b)(2)(B). Pub. L. 109–415, § 103(2)(B), added
subpar. (B) and struck out former subpar. (B) which related to severe need.
Subsec. (b)(2)(C), (D). Pub. L. 109–415, § 103(2)(C), added
subpar. (C) and struck out former subpars. (C) and (D)
which related to mechanism to utilize data to determine prevalence of HIV disease and the phasing in, over
a 3-year period beginning in fiscal year 1998, of the use
of such mechanism to determine severe needs, respectively.
Subsec. (c). Pub. L. 109–415, § 104(2), added subsec. (c).
Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 109–415, § 107(b), substituted ‘‘this
subpart’’ for ‘‘this part’’.
Pub. L. 109–415, § 104(1), redesignated subsec. (c) as (d).
Subsec. (e). Pub. L. 109–415, § 104(3), added subsec. (e).
2000—Subsec. (a)(2). Pub. L. 106–345, § 111(a), substituted ‘‘for a fiscal year’’ for ‘‘for each of the fiscal
years 1996 through 2000’’ in first sentence.
Subsec. (a)(3)(C)(i). Pub. L. 106–345, § 111(b)(1)(A), inserted before semicolon ‘‘, except that (subject to subparagraph (D)), for grants made pursuant to this paragraph for fiscal year 2005 and subsequent fiscal years,
the cases counted for each 12-month period beginning
on or after July 1, 2004, shall be cases of HIV disease (as
reported to and confirmed by such Director) rather
than cases of acquired immune deficiency syndrome’’.
Subsec. (a)(3)(C). Pub. L. 106–345, § 111(b)(1)(B), in concluding provisions, inserted before period at end of first
sentence ‘‘, and shall be reported to the congressional
committees of jurisdiction’’ and inserted at end ‘‘Updates shall as applicable take into account the counting of cases of HIV disease pursuant to clause (i).’’
Subsec. (a)(3)(D), (E). Pub. L. 106–345, § 111(b)(2), added
subpar. (D) and redesignated former subpar. (D) as (E).
Subsec. (a)(4). Pub. L. 106–345, § 111(c), amended heading and text of par. (4) generally. Prior to amendment,
text read as follows: ‘‘With respect to an eligible area
under section 300ff–11(a) of this title, the Secretary
shall increase the amount of a grant under paragraph
(2) for a fiscal year to ensure that such eligible area receives not less than—
‘‘(A) with respect to fiscal year 1996, 100 percent;
‘‘(B) with respect to fiscal year 1997, 99 percent;
‘‘(C) with respect to fiscal year 1998, 98 percent;
‘‘(D) with respect to fiscal year 1999, 96.5 percent;
and

Page 1218

‘‘(E) with respect to fiscal year 2000, 95 percent;
of the amount allocated for fiscal year 1995 to such entity under this subsection.’’
Subsec. (b)(1)(E). Pub. L. 106–345, § 112(b), inserted
‘‘youth,’’ after ‘‘children,’’.
Subsec. (b)(2). Pub. L. 106–345, § 112(a)(1), substituted
‘‘Amount of grant’’ for ‘‘Definition’’ in heading.
Subsec. (b)(2)(A). Pub. L. 106–345, § 112(a)(3), added
subpar. (A). Former subpar. (A) redesignated (B).
Subsec. (b)(2)(B). Pub. L. 106–345, § 112(a)(2), (4), redesignated subpar. (A) as (B) and added cls. (iv) to (vi).
Former subpar. (B) redesignated (C).
Subsec. (b)(2)(C). Pub. L. 106–345, § 112(a)(5)(C), inserted after second sentence ‘‘Such a mechanism shall
be modified to reflect the findings of the study under
section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between epidemiological measures and health care for certain individuals with HIV disease).’’
Pub. L. 106–345, § 112(a)(5)(B), in second sentence, substituted ‘‘18 months after October 20, 2000’’ for ‘‘2 years
after May 20, 1996’’.
Pub. L. 106–345, § 112(a)(5)(A), substituted ‘‘subparagraph (B)’’ for ‘‘subparagraph (A)’’ in two places.
Pub. L. 106–345, § 112(a)(2), redesignated subpar. (B) as
(C). Former subpar. (C) redesignated (D).
Subsec. (b)(2)(D). Pub. L. 106–345, § 112(a)(2), (6), redesignated subpar. (C) as (D) and substituted ‘‘subparagraph (C)’’ for ‘‘subparagraph (B)’’.
Subsec. (b)(4). Pub. L. 106–345, § 112(c)(1), (2), redesignated par. (5) as (4) and struck out heading and text of
former par. (4). Text read as follows: ‘‘The amount of
each grant made for purposes of this subsection shall be
determined by the Secretary based on the application
submitted by the eligible area under section 300ff–15(b)
of this title.’’
Subsec. (b)(4)(B). Pub. L. 106–345, § 112(c)(3), substituted ‘‘an expedited grant’’ for ‘‘an expedited
grants’’.
Subsec. (b)(5). Pub. L. 106–345, § 112(c)(2), redesignated
par. (5) as (4).
Subsec. (c). Pub. L. 106–345, § 102(d), substituted ‘‘section 300ff–12(b)(4)(C) of this title’’ for ‘‘section
300ff–12(b)(3)(A) of this title’’.
1996—Subsec. (a)(2). Pub. L. 104–146, § 6(c)(1)(A), substituted ‘‘section 300ff–77’’ for ‘‘section 300ff–18’’.
Pub. L. 104–146, § 3(b)(3)(A), inserted ‘‘, in accordance
with paragraph (3)’’ after ‘‘section 300ff–11(a) of this
title’’ and ‘‘The Secretary shall reserve an additional
percentage of the amount appropriated under section
300ff–77 of this title for a fiscal year for grants under
this part to make grants to eligible areas under section
300ff–11(a) of this title in accordance with paragraph
(4).’’ at end.
Pub. L. 104–146, § 3(b)(2)(A), substituted ‘‘Not later
than 60 days after an appropriation becomes available
to carry out this part for each of the fiscal years 1996
through 2000, the Secretary shall’’ for ‘‘Not later than—
‘‘(A) 90 days after an appropriation becomes available to carry out this part for fiscal year 1991; and
‘‘(B) 60 days after an appropriation becomes available to carry out this part for each of fiscal years 1992
through 1995;
the Secretary shall’’.
Subsec. (a)(3). Pub. L. 104–146, § 4, amended par. (3)
generally, revising and restating provisions of former
subpars. (A) to (C) relating to amount of grants under
par. (3) as subpars. (A) to (D).
Subsec. (a)(4). Pub. L. 104–146, § 3(b)(3)(B), added par.
(4).
Subsec. (b)(1). Pub. L. 104–146, § 6(c)(1)(B), substituted
‘‘section 300ff–77’’ for ‘‘section 300ff–18’’ in introductory
provisions.
Subsec. (b)(1)(F), (G). Pub. L. 104–146, § 3(b)(2)(B)(i),
added subpars. (F) and (G).
Subsec. (b)(2) to (4). Pub. L. 104–146, § 3(b)(2)(B)(ii),
(iii), added par. (2) and redesignated former pars. (2)
and (3) as (3) and (4), respectively. Former par. (4) redesignated (5).
Subsec. (b)(4)(B). Pub. L. 104–146, § 12(c)(2), which directed substitution of ‘‘an expedited grant’’ for ‘‘an ex-

Page 1219

TITLE 42—THE PUBLIC HEALTH AND WELFARE

pedited grants’’ in par. (4)(B), could not be executed because the words ‘‘an expedited grants’’ did not appear
in par. (4)(B) subsequent to redesignation of par. (4) as
(5) by Pub. L. 104–146, § 3(b)(2)(B)(ii). See above.
Subsec. (b)(5). Pub. L. 104–146, § 3(b)(2)(B)(ii), redesignated par. (4) as (5).
Subsec. (c). Pub. L. 104–146, § 3(b)(3)(C), added subsec.
(c).
1992—Subsec. (a)(3)(B)(i). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
1990—Subsec. (a)(3). Pub. L. 101–502 amended par. (3)
generally. Prior to amendment, par. (3) read as follows:
‘‘(A) IN GENERAL.—Subject to the extent of amounts
made available in appropriations Acts, a grant made
for purposes of this paragraph for an eligible area shall
be made in an amount equal to the sum of—
‘‘(i) an amount determined in accordance with subparagraph (B); and
‘‘(ii) an amount determined in accordance with subparagraph (C).
‘‘(B) AMOUNT RELATING TO CUMULATIVE NUMBER OF
CASES.—The amount referred to in clause (i) of subparagraph (A) is an amount equal to the product of—
‘‘(i) an amount equal to 75 percent of the amounts
available for distribution under paragraph (2) for the
fiscal year involved; and
‘‘(ii) a percentage equal to the quotient of—
‘‘(I) the cumulative number of cases of acquired
immune deficiency syndrome in the eligible area
involved, as indicated by the number of such cases
reported to and confirmed by the Director of the
Centers for Disease Control on the applicable date
described in section 300ff–11(a) of this title; divided
by
‘‘(II) the sum of the cumulative number of such
cases in all eligible areas for which an application
for a grant under paragraph (1) has been approved.
‘‘(C) AMOUNT RELATING TO PER CAPITA INCIDENCE OF
CASES.—The amount referred to in clause (ii) of subparagraph (A) is an amount equal to the product of—
‘‘(i) an amount equal to 25 percent of the amounts
available for distribution under paragraph (2) for the
fiscal year involved; and
‘‘(ii) a percentage developed by the Secretary
through consideration of the ratio of—
‘‘(I) the per capita incidence of cumulative cases
of acquired immune deficiency syndrome in the eligible area involved (computed on the basis of the
most recently available data on the population of
the area); to
‘‘(II) the per capita incidence of such cumulative
cases in all eligible areas for which an application
for a grant under paragraph (1) has been approved
(computed on the basis of the most recently available data on the population of such areas).’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 3(a), 5(a), 6(b), 7(a), and 8(a)(1), (b)(1)(A),
(2)(A), (C), (c)(1) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by sections 3(b)(2), (3), 4, 6(c)(1)(B), and
12(c)(2) of Pub. L. 104–146 effective Oct. 1, 1996, and
amendment by section 6(c)(1)(A) of Pub. L. 104–146 effective May 20, 1996, see section 13 of Pub. L. 104–146, set
out as a note under section 300ff–11 of this title.

§ 300ff–14. Use of amounts
(a) Requirements
The Secretary may not make a grant under
section 300ff–11(a) of this title to the chief elect-

§ 300ff–14

ed official of an eligible area unless such political subdivision agrees that—
(1) subject to paragraph (2), the allocation of
funds and services within the eligible area will
be made in accordance with the priorities established, pursuant to section 300ff–12(b)(4)(C)
of this title, by the HIV health services planning council that serves such eligible area;
(2) funds provided under section 300ff–11 of
this title will be expended only for—
(A) core medical services described in subsection (c);
(B) support services described in subsection (d); and
(C) administrative expenses described in
subsection (h); and
(3) the use of such funds will comply with
the requirements of this section.
(b) Direct financial assistance to appropriate entities
(1) In general
The chief elected official of an eligible area
shall use amounts from a grant under section
300ff–11 of this title to provide direct financial
assistance to entities described in paragraph
(2) for the purpose of providing core medical
services and support services.
(2) Appropriate entities
Direct financial assistance may be provided
under paragraph (1) to public or nonprofit private entities, or private for-profit entities if
such entities are the only available provider of
quality HIV care in the area.
(c) Required funding for core medical services
(1) In general
With respect to a grant under section
300ff–11 of this title for an eligible area for a
grant year, the chief elected official of the
area shall, of the portion of the grant remaining after reserving amounts for purposes of
paragraphs (1) and (5)(B)(i) of subsection (h),
use not less than 75 percent to provide core
medical services that are needed in the eligible area for individuals with HIV/AIDS who
are identified and eligible under this subchapter (including services regarding the cooccurring conditions of the individuals).
(2) Waiver
(A) In general
The Secretary shall waive the application
of paragraph (1) with respect to a chief elected official for a grant year if the Secretary
determines that, within the eligible area involved—
(i) there are no waiting lists for AIDS
Drug Assistance Program services under
section 300ff–26 of this title; and
(ii) core medical services are available to
all individuals with HIV/AIDS identified
and eligible under this subchapter.
(B) Notification of waiver status
When informing the chief elected official
of an eligible area that a grant under section
300ff–11 of this title is being made for the
area for a grant year, the Secretary shall inform the official whether a waiver under
subparagraph (A) is in effect for such year.

§ 300ff–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Core medical services
For purposes of this subsection, the term
‘‘core medical services’’, with respect to an individual with HIV/AIDS (including the co-occurring conditions of the individual), means
the following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments in accordance with section 300ff–26 of
this title.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (e).
(F) Health insurance premium and cost
sharing assistance for low-income individuals in accordance with section 300ff–25 of
this title.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 300ff–24(c)
of this title.
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(d) Support services
(1) In general
For purposes of this section, the term ‘‘support services’’ means services, subject to the
approval of the Secretary, that are needed for
individuals with HIV/AIDS to achieve their
medical outcomes (such as respite care for persons caring for individuals with HIV/AIDS,
outreach services, medical transportation, linguistic services, and referrals for health care
and support services).
(2) Medical outcomes
In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting the
HIV-related clinical status of an individual
with HIV/AIDS.
(e) Early intervention services
(1) In general
For purposes of this section, the term ‘‘early
intervention services’’ means HIV/AIDS early
intervention services described in section
300ff–51(e) of this title, with follow-up referral
provided for the purpose of facilitating the access of individuals receiving the services to
HIV-related health services. The entities
through which such services may be provided
under the grant include public health departments, emergency rooms, substance abuse and
mental health treatment programs, detoxification centers, detention facilities, clinics regarding sexually transmitted diseases, homeless shelters, HIV/AIDS counseling and testing
sites, health care points of entry specified by
eligible areas, federally qualified health centers, and entities described in section
300ff–52(a) of this title that constitute a point
of access to services by maintaining referral
relationships.
(2) Conditions
With respect to an entity that proposes to
provide early intervention services under

Page 1220

paragraph (1), such paragraph shall apply only
if the entity demonstrates to the satisfaction
of the chief elected official for the eligible
area involved that—
(A) Federal, State, or local funds are
otherwise inadequate for the early intervention services the entity proposes to provide;
and
(B) the entity will expend funds pursuant
to such paragraph to supplement and not
supplant other funds available to the entity
for the provision of early intervention services for the fiscal year involved.
(f) Priority for women, infants, children, and
youth
(1) In general
For the purpose of providing health and support services to infants, children, youth, and
women with HIV/AIDS, including treatment
measures to prevent the perinatal transmission of HIV, the chief elected official of an
eligible area, in accordance with the established priorities of the planning council, shall
for each of such populations in the eligible
area use, from the grants made for the area
under section 300ff–11(a) of this title for a fiscal year, not less than the percentage constituted by the ratio of the population involved (infants, children, youth, or women in
such area) with HIV/AIDS to the general population in such area of individuals with HIV/
AIDS.
(2) Waiver
With respect to the population involved, the
Secretary may provide to the chief elected official of an eligible area a waiver of the requirement of paragraph (1) if such official
demonstrates to the satisfaction of the Secretary that the population is receiving HIV-related health services through the State medicaid program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], the State
children’s health insurance program under
title XXI of such Act [42 U.S.C. 1397aa et seq.],
or other Federal or State programs.
(g) Requirement of status as medicaid provider
(1) Provision of service
Subject to paragraph (2), the Secretary may
not make a grant under section 300ff–11(a) of
this title for the provision of services under
this section in a State unless, in the case of
any such service that is available pursuant to
the State plan approved under title XIX of the
Social Security Act [42 U.S.C. 1396 et seq.] for
the State—
(A) the political subdivision involved will
provide the service directly, and the political subdivision has entered into a participation agreement under the State plan and is
qualified to receive payments under such
plan; or
(B) the political subdivision will enter into
an agreement with a public or nonprofit private entity under which the entity will provide the service, and the entity has entered
into such a participation agreement and is
qualified to receive such payments.

Page 1221

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Waiver
(A) In general
In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding
the provision of services, the requirement
established in such paragraph shall be
waived by the HIV health services planning
council for the eligible area if the entity
does not, in providing health care services,
impose a charge or accept reimbursement
available from any third-party payor, including reimbursement under any insurance
policy or under any Federal or State health
benefits program.
(B) Determination
A determination by the HIV health services planning council of whether an entity
referred to in subparagraph (A) meets the
criteria for a waiver under such subparagraph shall be made without regard to
whether the entity accepts voluntary donations for the purpose of providing services to
the public.
(h) Administration
(1) Limitation
The chief elected official of an eligible area
shall not use in excess of 10 percent of
amounts received under a grant under this
subpart for administrative expenses.
(2) Allocations by chief elected official
In the case of entities and subcontractors to
which the chief elected official of an eligible
area allocates amounts received by the official
under a grant under this subpart, the official
shall ensure that, of the aggregate amount so
allocated, the total of the expenditures by
such entities for administrative expenses does
not exceed 10 percent (without regard to
whether particular entities expend more than
10 percent for such expenses).
(3) Administrative activities
For purposes of paragraph (1), amounts may
be used for administrative activities that include—
(A) routine grant administration and monitoring activities, including the development
of applications for part A funds, the receipt
and disbursal of program funds, the development and establishment of reimbursement
and accounting systems, the development of
a clinical quality management program as
described in paragraph (5), the preparation
of routine programmatic and financial reports, and compliance with grant conditions
and audit requirements; and
(B) all activities associated with the
grantee’s contract award procedures, including the activities carried out by the HIV
health services planning council as established under section 300ff–12(b) of this title,
the development of requests for proposals,
contract proposal review activities, negotiation and awarding of contracts, monitoring
of contracts through telephone consultation,
written documentation or onsite visits, reporting on contracts, and funding reallocation activities.

§ 300ff–14

(4) Subcontractor administrative activities
For the purposes of this subsection, subcontractor administrative activities include—
(A) usual and recognized overhead activities, including established indirect rates for
agencies;
(B) management oversight of specific programs funded under this subchapter; and
(C) other types of program support such as
quality assurance, quality control, and related activities.
(5) Clinical quality management
(A) Requirement
The chief elected official of an eligible
area that receives a grant under this subpart
shall provide for the establishment of a clinical quality management program to assess
the extent to which HIV health services provided to patients under the grant are consistent with the most recent Public Health
Service guidelines for the treatment of HIV/
AIDS and related opportunistic infection,
and as applicable, to develop strategies for
ensuring that such services are consistent
with the guidelines for improvement in the
access to and quality of HIV health services.
(B) Use of funds
(i) In general
From amounts received under a grant
awarded under this subpart for a fiscal
year, the chief elected official of an eligible area may use for activities associated
with the clinical quality management program required in subparagraph (A) not to
exceed the lesser of—
(I) 5 percent of amounts received under
the grant; or
(II) $3,000,000.
(ii) Relation to limitation on administrative
expenses
The costs of a clinical quality management program under subparagraph (A)
may not be considered administrative expenses for purposes of the limitation established in paragraph (1).
(i) Construction
A chief elected official may not use amounts
received under a grant awarded under this subpart to purchase or improve land, or to purchase, construct, or permanently improve (other
than minor remodeling) any building or other
facility, or to make cash payments to intended
recipients of services.
(July 1, 1944, ch. 373, title XXVI, § 2604, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 580; amended Pub. L. 103–446, title XII,
§ 1203(a)(3), Nov. 2, 1994, 108 Stat. 4689; Pub. L.
104–146, § 3(b)(4), May 20, 1996, 110 Stat. 1351; Pub.
L. 106–345, title I, § 121, Oct. 20, 2000, 114 Stat.
1326; Pub. L. 109–415, title I, §§ 105, 107(b), title
VII, § 703, Dec. 19, 2006, 120 Stat. 2776, 2783, 2820;
Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123
Stat. 2885.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (f)(2)
and (g)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.

§ 300ff–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Titles XIX and XXI of the Act are classified generally
to subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.
PRIOR PROVISIONS
A prior section 2604 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238c of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 105, amended section generally.
Prior to amendment, section related to requirements
for allocation of funds, purposes for use of amounts,
quality management program, expenditures for personnel, status of grantee as medicaid provider, administrative activities and expenses, and prohibited uses of
amounts.
Subsecs. (h)(1), (2), (5)(A) and (i). Pub. L. 109–415,
§ 107(b), substituted ‘‘this subpart’’ for ‘‘this part’’.
2000—Subsec. (b)(1). Pub. L. 106–345, § 121(a)(1), substituted ‘‘HIV-related services, as follows:’’ for ‘‘HIVrelated—’’ in introductory provisions.
Subsec. (b)(1)(A). Pub. L. 106–345, § 121(a)(2), substituted ‘‘Outpatient and ambulatory health services,
including substance abuse treatment,’’ for ‘‘outpatient
and ambulatory health and support services, including
case management, substance abuse treatment and’’ and
substituted a period for ‘‘; and’’ at end.
Subsec. (b)(1)(B). Pub. L. 106–345, § 121(a)(4), added subpar. (B). Former subpar. (B) redesignated (C).
Subsec. (b)(1)(C). Pub. L. 106–345, § 121(a)(3), redesignated subpar. (B) as (C) and substituted ‘‘Inpatient’’ for
‘‘inpatient’’.
Subsec. (b)(1)(D). Pub. L. 106–345, § 121(a)(5), added
subpar. (D).
Subsec. (b)(3). Pub. L. 106–345, § 121(b)(2), added par.
(3). Former par. (3) redesignated (4).
Subsec. (b)(4). Pub. L. 106–345, § 121(b)(1), (c), redesignated par. (3) as (4) and amended heading and text of
par. (4) generally. Prior to amendment, text read as follows: ‘‘For the purpose of providing health and support
services to infants, children, and women with HIV disease, including treatment measures to prevent the perinatal transmission of HIV, the chief elected official of
an eligible area, in accordance with the established priorities of the planning council, shall use, from the
grants made for the area under section 300ff–11(a) of
this title for a fiscal year, not less than the percentage
constituted by the ratio of the population in such area
of infants, children, and women with acquired immune
deficiency syndrome to the general population in such
area of individuals with such syndrome.’’
Subsecs. (c) to (g). Pub. L. 106–345, § 121(d), added subsec. (c) and redesignated former subsecs. (c) to (f) as (d)
to (g), respectively.
1996—Subsec. (b)(1)(A). Pub. L. 104–146, § 3(b)(4)(A), inserted ‘‘, substance abuse treatment and mental health
treatment,’’ after ‘‘case management’’ and ‘‘which
shall include treatment education and prophylactic
treatment for opportunistic infections,’’ after ‘‘treatment services,’’.
Subsec. (b)(2)(A). Pub. L. 104–146, § 3(b)(4)(B), inserted
‘‘, or private for-profit entities if such entities are the
only available provider of quality HIV care in the
area,’’ after ‘‘nonprofit private entities,’’ and substituted ‘‘homeless health centers, substance abuse
treatment programs, and mental health programs’’ for
‘‘and homeless health centers’’.
Subsec. (b)(3). Pub. L. 104–146, § 3(b)(4)(C), added par.
(3).

Page 1222

Subsec. (e). Pub. L. 104–146, § 3(b)(4)(C), struck out
‘‘and planning’’ after ‘‘Administration’’ in heading, designated existing provisions as par. (1), inserted par.
heading, struck out ‘‘accounting, reporting, and program oversight functions’’ after ‘‘for administration,’’,
inserted at end ‘‘In the case of entities and subcontractors to which such officer allocates amounts received
by the officer under the grant, the officer shall ensure
that, of the aggregate amount so allocated, the total of
the expenditures by such entities for administrative expenses does not exceed 10 percent (without regard to
whether particular entities expend more than 10 percent for such expenses).’’, and added pars. (2) and (3).
1994—Subsec. (b)(2)(A). Pub. L. 103–446 substituted
‘‘Department of Veterans Affairs facilities’’ for ‘‘Veterans Administration facilities’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–15. Application
(a) In general
To be eligible to receive a grant under section
300ff–11 of this title, an eligible area shall prepare and submit to the Secretary an application,
in accordance with subsection (c) of this section
regarding a single application and grant award,
at such time, in such form, and containing such
information as the Secretary shall require, including assurances adequate to ensure—
(1)(A) that funds received under a grant
awarded under this subpart will be utilized to
supplement not supplant State funds made
available in the year for which the grant is
awarded to provide HIV-related services as described in section 300ff–14(b)(1) of this title;
(B) that the political subdivisions within the
eligible area will maintain the level of expenditures by such political subdivisions for HIVrelated services as described in section
300ff–14(b)(1) of this title at a level that is
equal to the level of such expenditures by such
political subdivisions for the preceding fiscal
year; and
(C) that political subdivisions within the eligible area will not use funds received under a
grant awarded under this subpart in maintaining the level of expenditures for HIV-related
services as required in subparagraph (B);
(2) that the eligible area has an HIV health
services planning council and has entered into
intergovernmental agreements pursuant to
section 300ff–12 of this title, and has developed
or will develop the comprehensive plan in accordance with section 300ff–12(b)(3)(B) 1 of this
title;
(3) that entities within the eligible area that
receive funds under a grant under this subpart
will maintain appropriate relationships with
entities in the eligible area served that con1 See

References in Text note below.

Page 1223

TITLE 42—THE PUBLIC HEALTH AND WELFARE

stitute key points of access to the health care
system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs, detoxification centers, adult
and juvenile detention facilities, sexually
transmitted disease clinics, HIV counseling
and testing sites, mental health programs, and
homeless shelters), and other entities under
section 2 300ff–14(b)(3) 1 and 300ff–52(a) of this
title, for the purpose of facilitating early
intervention for individuals newly diagnosed
with HIV/AIDS and individuals knowledgeable
of their HIV status but not in care;
(4) that the chief elected official of the eligible area will satisfy all requirements under
section 300ff–14(c) of this title;
(5) that entities within the eligible area that
will receive funds under a grant provided
under section 300ff–11(a) of this title shall participate in an established HIV communitybased continuum of care if such continuum exists within the eligible area;
(6) that funds received under a grant awarded under this subpart will not be utilized to
make payments for any item or service to the
extent that payment has been made, or can
reasonably be expected to be made, with respect to that item or service—
(A) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program (except for a program administered by
or providing the services of the Indian
Health Service); or
(B) by an entity that provides health services on a prepaid basis;
(7) to the maximum extent practicable,
that—
(A) HIV health care and support services
provided with assistance made available
under this subpart will be provided without
regard—
(i) to the ability of the individual to pay
for such services; and
(ii) to the current or past health condition of the individual to be served;
(B) such services will be provided in a setting that is accessible to low-income individuals with HIV/AIDS; and
(C) a program of outreach will be provided
to low-income individuals with HIV/AIDS to
inform such individuals of such services;
(8) that the applicant has participated, or
will agree to participate, in the statewide
coordinated statement of need process where
it has been initiated by the State public
health agency responsible for administering
grants under part B of this subchapter, and ensure that the services provided under the comprehensive plan are consistent with the statewide coordinated statement of need;
(9) that the eligible area has procedures in
place to ensure that services provided with
funds received under this subpart meet the criteria specified in section 300ff–14(b)(1) of this
title; and
(10) that the chief elected official will submit to the lead State agency under section
2 So

in original. Probably should be ‘‘sections’’.

§ 300ff–15

300ff–27(b)(4) of this title, audits, consistent
with Office of Management and Budget circular A133, regarding funds expended in accordance with this subpart every 2 years and
shall include necessary client-based data to
compile unmet need calculations and Statewide coordinated statements of need process.
(b) Application
An eligible area that desires to receive a grant
under section 300ff–13(b) of this title shall prepare and submit to the Secretary an application,
in accordance with subsection (c) of this section
regarding a single application and grant award,
at such time, in such form, and containing such
information as the Secretary shall require, including the information required under such
subsection and information concerning—
(1) the number of individuals to be served
within the eligible area with assistance provided under the grant, including the identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of section
300ff–13(b)(2)(A) of this title;
(2) demographic data on the population of
such individuals;
(3) the average cost of providing each category of HIV-related health services and the
extent to which such cost is paid by thirdparty payors;
(4) the aggregate amounts expended for each
such category of services;
(5) the manner in which the expected expenditures are related to the planning process
for States that receive funding under part B
(including the planning process described in
section 300ff–27(b) of this title); and
(6) the expected expenditures and how those
expenditures will improve overall client outcomes, as described under the State plan
under section 300ff–27(b) of this title, and
through additional outcomes measures as
identified by the HIV health services planning
council under section 300ff–12(b) of this title.
(c) Single application and grant award
(1) Application
The Secretary may phase in the use of a single application that meets the requirements of
subsections (a) and (b) of section 300ff–13 of
this title with respect to an eligible area that
desires to receive grants under section 300ff–13
of this title for a fiscal year.
(2) Grant award
The Secretary may phase in the awarding of
a single grant to an eligible area that submits
an approved application under paragraph (1)
for a fiscal year.
(d) Date certain for submission
(1) Requirement
Except as provided in paragraph (2), to be eligible to receive a grant under section
300ff–11(a) of this title for a fiscal year, an application under subsection (a) of this section
shall be submitted not later than 45 days after
the date on which appropriations are made
under section 300ff–77 of this title for the fiscal
year.
(2) Exception
The Secretary may extend the time for the
submission of an application under paragraph

§ 300ff–15

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) for a period of not to exceed 60 days if the
Secretary determines that the eligible area
has made a good faith effort to comply with
the requirement of such paragraph but has
otherwise been unable to submit its application.
(3) Distribution by Secretary
Not later than 45 days after receiving an application that meets the requirements of subsection (a) of this section from an eligible
area, the Secretary shall distribute to such eligible area the amounts awarded under the
grant for which the application was submitted.
(4) Redistribution
Any amounts appropriated in any fiscal year
under this subpart and not obligated to an eligible entity as a result of the failure of such
entity to submit an application shall be redistributed by the Secretary to other eligible entities in proportion to the original grants
made to such eligible areas under section
300ff–11(a) of this title.
(e) Requirements regarding imposition of
charges for services
(1) In general
The Secretary may not make a grant under
section 300ff–11 of this title to an eligible area
unless the eligible area provides assurances
that in the provision of services with assistance provided under the grant—
(A) in the case of individuals with an income less than or equal to 100 percent of the
official poverty line, the provider will not
impose charges on any such individual for
the provision of services under the grant;
(B) in the case of individuals with an income greater than 100 percent of the official
poverty line, the provider—
(i) will impose a charge on each such individual for the provision of such services;
and
(ii) will impose the charge according to a
schedule of charges that is made available
to the public;
(C) in the case of individuals with an income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an
amount exceeding 5 percent of the annual
gross income of the individual involved;
(D) in the case of individuals with an income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an
amount exceeding 7 percent of the annual
gross income of the individual involved; and
(E) in the case of individuals with an income greater than 300 percent of the official
poverty line, the provider will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income of the individual involved.
(2) Assessment of charge
With respect to compliance with the assurance made under paragraph (1), a grantee or

Page 1224

entity receiving assistance under this subpart
may, in the case of individuals subject to a
charge for purposes of such paragraph—
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules and regarding limitations on the maximum
amount of charges; and
(B) take into consideration the medical expenses of individuals in assessing the
amount of the charge, subject to such provisions.
(3) Applicability of limitation on amount of
charge
The Secretary may not make a grant under
section 300ff–11 of this title to an eligible area
unless the eligible area agrees that the limitations established in subparagraphs (C), (D) and
(E) of paragraph (1) regarding the imposition
of charges for services applies to the annual
aggregate of charges imposed for such services, without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance, or other charges.
(4) Waiver regarding secondary agreements
The requirements established in paragraphs
(1) through (3) shall be waived in accordance
with section 300ff–14(d)(2) 1 of this title.
(July 1, 1944, ch. 373, title XXVI, § 2605, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 582; amended Pub. L. 104–146, §§ 3(b)(5),
6(c)(2), May 20, 1996, 110 Stat. 1352, 1368; Pub. L.
106–345, title I, § 122, title V, § 503(a)(1), Oct. 20,
2000, 114 Stat. 1329, 1354; Pub. L. 109–415, title I,
§§ 106(c), 107(b), title VII, §§ 702(3), 703, Dec. 19,
2006, 120 Stat. 2781, 2783, 2820; Pub. L. 111–87,
§§ 2(a)(1), (3)(A), 6(c), Oct. 30, 2009, 123 Stat. 2885,
2892.)
REFERENCES IN TEXT
Section 300ff–12(b) of this title, referred to in subsec.
(a)(2), was amended by Pub. L. 104–146, § 3(b)(1)(D), May
20, 1996, 110 Stat. 1348, to redesignate pars. (2) and (3) as
(3) and (4), respectively. As so redesignated, par. (3)(B)
relates to consideration regarding designation of councils and par. (4)(B) relates to development of a comprehensive plan.
Section 300ff–14 of this title, referred to in subsecs.
(a)(3) and (e)(4), was amended generally by Pub. L.
109–415, title I, § 105, Dec. 19, 2006, 120 Stat. 2776, and as
so amended, it does not contain a subsec. (b)(3) and subsec. (d)(2) does not relate to waivers.
PRIOR PROVISIONS
A prior section 2605 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238d of this title.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (b)(1). Pub. L. 111–87, § 6(c), inserted
‘‘, including the identification of individuals with HIV/
AIDS as described in clauses (i) through (iii) of section
300ff–13(b)(2)(A) of this title’’ before semicolon.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.

Page 1225

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 109–415, § 107(b), substituted ‘‘this subpart’’ for
‘‘this part’’ wherever appearing.
Subsec. (a)(3). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’ in two places.
Subsec. (a)(6)(A). Pub. L. 109–415, § 106(c)(1), inserted
‘‘(except for a program administered by or providing
the services of the Indian Health Service)’’ before semicolon.
Subsec. (a)(7)(B), (C). Pub. L. 109–415, § 702(3), which
directed the substitution of ‘‘HIV/AIDS’’ for ‘‘HIV disease’’, was executed by making the substitution for
‘‘HIV-disease’’, to reflect the probable intent of Congress.
Subsec. (a)(10). Pub. L. 109–415, § 106(c)(2), added par.
(10).
Subsec. (b)(5), (6). Pub. L. 109–415, § 106(c)(3), added
pars. (5) and (6).
2000—Subsec. (a)(1)(A). Pub. L. 106–345, § 122(b)(1)(A),
substituted
‘‘services
as
described
in
section
300ff–14(b)(1) of this title’’ for ‘‘services to individuals
with HIV disease’’.
Subsec. (a)(1)(B). Pub. L. 106–345, § 122(b)(1)(B), substituted ‘‘services as described in section 300ff–14(b)(1)
of this title’’ for ‘‘services for individuals with HIV disease’’.
Subsec. (a)(3) to (8). Pub. L. 106–345, § 122(a), added
pars. (3) and (4) and redesignated former pars. (3) to (6)
as (5) to (8), respectively.
Subsec. (a)(9). Pub. L. 106–345, § 122(b)(2)–(4), added
par. (9).
Subsec. (d)(1). Pub. L. 106–345, § 503(a)(1)(A), made
technical amendment to reference in original act which
appears in text as reference to section 300ff–77 of this
title.
Subsec. (d)(4). Pub. L. 106–345, § 503(a)(1)(B), inserted
‘‘section’’ before ‘‘300ff–11(a) of this title’’.
1996—Subsec. (a). Pub. L. 104–146, § 3(b)(5)(A)(i), inserted ‘‘, in accordance with subsection (c) of this section regarding a single application and grant award,’’
after ‘‘application’’ in introductory provisions.
Subsec. (a)(1)(B). Pub. L. 104–146, § 3(b)(5)(A)(ii), substituted ‘‘preceding fiscal year’’ for ‘‘1-year period preceding the first fiscal year for which a grant is received
by the eligible area’’.
Subsec. (a)(6). Pub. L. 104–146, § 3(b)(5)(A)(iii)–(v),
added par. (6).
Subsec. (b). Pub. L. 104–146, § 3(b)(5)(B), substituted
‘‘Application’’ for ‘‘Additional application’’ in heading
and substituted ‘‘application, in accordance with subsection (c) of this section regarding a single application
and grant award,’’ for ‘‘additional application’’ in introductory provisions.
Subsec. (c). Pub. L. 104–146, § 3(b)(5)(D), added subsec.
(c). Former subsec. (c) redesignated (d).
Subsec. (c)(1). Pub. L. 104–146, § 6(c)(2), which directed
substitution of ‘‘section 300ff–77 of this title’’ for ‘‘section 300ff–18 of this title’’ in subsec. (c)(1), could not be
executed because phrase ‘‘section 300ff–18 of this title’’
did not appear in text of subsec. (c)(1) subsequent to redesignation of subsec. (c) as (d) by Pub. L. 104–146,
§ 3(b)(5)(C). See below.
Subsec. (d). Pub. L. 104–146, § 3(b)(5)(C), redesignated
subsec. (c) as (d). Former subsec. (d) redesignated (e).
Subsec. (e). Pub. L. 104–146, § 3(b)(5)(C), redesignated
subsec. (d) as (e).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 6(c) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–16

§ 300ff–16. Technical assistance
The Administrator of the Health Resources
and Services Administration shall, beginning on
August 18, 1990, provide technical assistance, including assistance from other grantees, contractors or subcontractors under this subchapter to
assist newly eligible metropolitan areas in the
establishment of HIV health services planning
councils and, to assist entities in complying
with the requirements of this subpart in order to
make such entities eligible to receive a grant
under this subpart. The Administrator may
make planning grants available to metropolitan
areas, in an amount not to exceed $75,000 for any
metropolitan area, projected to be eligible for
funding under section 300ff–11 of this title in the
following fiscal year. Such grant amounts shall
be deducted from the first year formula award
to eligible areas accepting such grants. Not to
exceed 1 percent of the amount appropriated for
a fiscal year under section 300ff–77 of this title
for grants under this subpart may be used to
carry out this section.
(July 1, 1944, ch. 373, title XXVI, § 2606, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 585; amended Pub. L. 104–146, § 3(b)(6), May
20, 1996, 110 Stat. 1353; Pub. L. 109–415, title I,
§ 107(b), title VII, § 703, Dec. 19, 2006, 120 Stat.
2783, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30,
2009, 123 Stat. 2885.)
PRIOR PROVISIONS
A prior section 2606 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238e of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 107(b), substituted ‘‘this subpart’’ for
‘‘this part’’ wherever appearing.
1996—Pub. L. 104–146 substituted ‘‘Administration
shall’’ for ‘‘Administration may’’, inserted ‘‘, including
assistance from other grantees, contractors or subcontractors under this subchapter to assist newly eligible metropolitan areas in the establishment of HIV
health services planning councils and,’’ after ‘‘technical assistance’’, and inserted at end ‘‘The Administrator may make planning grants available to metropolitan areas, in an amount not to exceed $75,000 for
any metropolitan area, projected to be eligible for
funding under section 300ff–11 of this title in the following fiscal year. Such grant amounts shall be deducted
from the first year formula award to eligible areas accepting such grants. Not to exceed 1 percent of the
amount appropriated for a fiscal year under section
300ff–77 of this title for grants under this part may be
used to carry out this section.’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–17

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–17. Definitions
For purposes of this subpart:
(1) Eligible area
The term ‘‘eligible area’’ means a metropolitan area meeting the requirements of section
300ff–11 of this title that are applicable to the
area.
(2) Metropolitan area
The term ‘‘metropolitan area’’ means an
area that is referred to in the HIV/AIDS Surveillance Report of the Centers for Disease
Control and Prevention as a metropolitan
area, and that has a population of 50,000 or
more individuals.
(July 1, 1944, ch. 373, title XXVI, § 2607, as added
Pub. L. 101–381, title I, § 101(3), Aug. 18, 1990, 104
Stat. 585; amended Pub. L. 101–557, title IV,
§ 401(b)(1), Nov. 15, 1990, 104 Stat. 2771; Pub. L.
102–531, title III, § 312(d)(28), Oct. 27, 1992, 106
Stat. 3506; Pub. L. 104–146, § 3(a)(3), May 20, 1996,
110 Stat. 1347; Pub. L. 109–415, title I, §§ 101(c),
107(b), title VII, § 703, Dec. 19, 2006, 120 Stat. 2768,
2783, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30,
2009, 123 Stat. 2885.)
PRIOR PROVISIONS
A prior section 2607 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238f of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 107(b), substituted ‘‘this subpart’’ for
‘‘this part’’ in introductory provisions.
Par. (2). Pub. L. 109–415, § 101(c), substituted ‘‘area
that is referred’’ for ‘‘area referred’’ and inserted
‘‘, and that has a population of 50,000 or more individuals’’ before period at end.
1996—Par. (1). Pub. L. 104–146 substituted ‘‘The term
‘eligible area’ means a metropolitan area meeting the
requirements of section 300ff–11 of this title that are
applicable to the area.’’ for ‘‘The term ‘eligible area’
means a metropolitan area described in section
300ff–11(a) of this title.’’
1992—Par. (2). Pub. L. 102–531 substituted ‘‘Centers for
Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
1990—Par. (1). Pub. L. 101–557 substituted ‘‘300ff–11(a)’’
for ‘‘300ff–11(a)(1)’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

Page 1226

§ 300ff–18. Repealed. Pub. L. 104–146, § 6(b), May
20, 1996, 110 Stat. 1367
Section, act July 1, 1944, ch. 373, title XXVI, § 2608, as
added Aug. 18, 1990, Pub. L. 101–381, title I, § 101(3), 104
Stat. 585, authorized appropriations for fiscal years 1991
through 1995.
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1996, see section 13 of Pub. L.
104–146, set out as an Effective Date of 1996 Amendment
note under section 300ff–11 of this title.
SUBPART II—TRANSITIONAL GRANTS

§ 300ff–19. Establishment of program
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants for the purpose
of providing services described in section 300ff–14
of this title in transitional areas, subject to the
same provisions regarding the allocation of
grant funds as apply under subsection (c) of such
section.
(b) Transitional areas
For purposes of this section, the term ‘‘transitional area’’ means, subject to subsection (c), a
metropolitan area for which there has been reported to and confirmed by the Director of the
Centers for Disease Control and Prevention a cumulative total of at least 1,000, but fewer than
2,000, cases of AIDS during the most recent period of 5 calendar years for which such data are
available.
(c) Certain eligibility rules
(1) Fiscal year 2011
With respect to grants under subsection (a)
for fiscal year 2011, a metropolitan area that
received funding under subpart I for fiscal
year 2010 but does not for fiscal year 2011 qualify under such subpart as an eligible area and
does not qualify under subsection (b) as a transitional area shall, notwithstanding subsection (b), be considered a transitional area.
(2) Continued status as transitional area
(A) In general
Notwithstanding subsection (b), a metropolitan area that is a transitional area for a
fiscal year continues, except as provided in
subparagraph (B), to be a transitional area
until the metropolitan area fails, for three
consecutive fiscal years—
(i) to qualify under such subsection as a
transitional area; and
(ii) subject to subparagraphs (B) and (C),
to have a cumulative total of 1,500 or more
living cases of AIDS (reported to and confirmed by the Director of the Centers for
Disease Control and Prevention) as of December 31 of the most recent calendar year
for which such data is available.
(B) Permitting margin of error applicable to
certain metropolitan areas
In applying subparagraph (A)(ii) for a fiscal year after fiscal year 2008, in the case of
a metropolitan area that has a cumulative
total of at least 1,400 (and fewer than 1,500)

Page 1227

TITLE 42—THE PUBLIC HEALTH AND WELFARE

living cases of AIDS as of December 31 of the
most recent calendar year for which such
data is available, such area shall be treated
as having met the criteria of such subparagraph if not more than 5 percent of the total
from grants awarded to such area under this
part is unobligated as of the end of the most
recent fiscal year for which such data is
available.
(C) Exception regarding status as eligible
area
Subparagraphs (A) and (B) do not apply for
a fiscal year if the metropolitan area involved qualifies under subpart I as an eligible area.
(d) Application of certain provisions of subpart I
(1) Administration; planning council
(A) In general
The provisions of section 300ff–12 of this
title apply with respect to a grant under
subsection (a) for a transitional area to the
same extent and in the same manner as such
provisions apply with respect to a grant
under subpart I for an eligible area, except
that, subject to subparagraph (B), the chief
elected official of the transitional area may
elect not to comply with the provisions of
section 300ff–12(b) of this title if the official
provides documentation to the Secretary
that details the process used to obtain community input (particularly from those with
HIV) in the transitional area for formulating
the overall plan for priority setting and allocating funds from the grant under subsection (a).
(B) Exception
For each of the fiscal years 2007 through
2013, the exception described in subparagraph (A) does not apply if the transitional
area involved received funding under subpart
I for fiscal year 2006.
(2) Type and distribution of grants; timeframe
for obligation and expenditure of grant
funds
(A) Formula grants; supplemental grants
The provisions of section 300ff–13 of this
title apply with respect to grants under subsection (a) to the same extent and in the
same manner as such provisions apply with
respect to grants under subpart I, subject to
subparagraphs (B) and (C).
(B) Formula grants; increase in grant
For purposes of subparagraph (A), section
300ff–13(a)(4) of this title does not apply.
(C) Supplemental grants; single program
with subpart I program
With respect to section 300ff–13(b) of this
title as applied for purposes of subparagraph
(A):
(i) The Secretary shall combine amounts
available pursuant to such subparagraph
with amounts available for carrying out
section 300ff–13(b) of this title and shall administer the two programs as a single program.
(ii) In the single program, the Secretary
has discretion in allocating amounts be-

§ 300ff–20

tween eligible areas under subpart I and
transitional areas under this section, subject to the eligibility criteria that apply
under such section, and subject to section
300ff–13(b)(2)(C) of this title (relating to
priority in making grants).
(iii) Pursuant to section 300ff–13(b)(1) of
this title, amounts for the single program
are subject to use under sections
300ff–13(a)(4) and 300ff–20(d)(1) of this title.
(3) Application; technical assistance; definitions
The provisions of sections 300ff–15, 300ff–16,
and 300ff–17 of this title apply with respect to
grants under subsection (a) to the same extent
and in the same manner as such provisions
apply with respect to grants under subpart I.
(July 1, 1944, ch. 373, title XXVI, § 2609, as added
and amended Pub. L. 109–415, title I, § 107(a)(2),
title VII, § 703, Dec. 19, 2006, 120 Stat. 2781, 2820;
Pub. L. 111–87, §§ 2(a)(1), (3)(A), 4(a), Oct. 30, 2009,
123 Stat. 2885, 2889.)
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (c)(1). Pub. L. 111–87, § 4(a)(1), in heading substituted ‘‘2011’’ for ‘‘2007’’ and in text substituted ‘‘2011’’
for ‘‘2007’’ in two places and ‘‘2010’’ for ‘‘2006’’.
Subsec. (c)(2)(A)(ii). Pub. L. 111–87, § 4(a)(2)(A), substituted ‘‘subject to subparagraphs (B) and (C), to have
a’’ for ‘‘to have a’’.
Subsec. (c)(2)(B). Pub. L. 111–87, § 4(a)(2)(B), (C), added
subpar. (B). Former subpar. (B) redesignated (C).
Subsec. (c)(2)(C). Pub. L. 111–87, § 4(a)(2)(B), (D), redesignated subpar. (B) as (C) and substituted ‘‘Subparagraphs (A) and (B) do not apply’’ for ‘‘Subparagraph (A)
does not apply’’.
Subsec. (d)(1)(B). Pub. L. 111–87, § 4(a)(3), substituted
‘‘2013’’ for ‘‘2009’’.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 4(a) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.
SUBPART III—GENERAL PROVISIONS

§ 300ff–20. Authorization of appropriations
(a) In general
For the purpose of carrying out this part,
there are authorized to be appropriated
$604,000,000 for fiscal year 2007, $626,300,000 for
fiscal year 2008, $649,500,000 for fiscal year 2009,
$681,975,000 for fiscal year 2010, $716,074,000 for
fiscal year 2011, $751,877,000 for fiscal year 2012,
and $789,471,000 for fiscal year 2013. Amounts appropriated under the preceding sentence for a
fiscal year are available for obligation by the
Secretary until the end of the second succeeding
fiscal year.

§ 300ff–20

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Reservation of amounts
(1) Fiscal year 2007
Of the amount appropriated under subsection (a) for fiscal year 2007, the Secretary
shall reserve—
(A) $458,310,000 for grants under subpart I;
and
(B) $145,690,000 for grants under section
300ff–19 of this title.
(2) Subsequent fiscal years
Of the amount appropriated under subsection (a) for fiscal year 2008 and each subsequent fiscal year—
(A) the Secretary shall reserve an amount
for grants under subpart I; and
(B) the Secretary shall reserve an amount
for grants under section 300ff–19 of this title.
(c) Transfer of certain amounts; change in status
as eligible area or transitional area
Notwithstanding subsection (b):
(1) If a metropolitan area is an eligible area
under subpart I for a fiscal year, but for a subsequent fiscal year ceases to be an eligible
area by reason of section 300ff–11(b) of this
title—
(A)(i) the amount reserved under paragraph (1)(A) or (2)(A) of subsection (b) of this
section for the first such subsequent year of
not being an eligible area is deemed to be reduced by an amount equal to the amount of
the grant made pursuant to section
300ff–13(a) of this title for the metropolitan
area for the preceding fiscal year; and
(ii)(I) if the metropolitan area qualifies for
such first subsequent fiscal year as a transitional area under 300ff–19 1 of this title, the
amount reserved under paragraph (1)(B) or
(2)(B) of subsection (b) for such fiscal year is
deemed to be increased by an amount equal
to the amount of the reduction under subparagraph (A) for such year; or
(II) if the metropolitan area does not qualify for such first subsequent fiscal year as a
transitional area under 300ff–19 1 of this title,
an amount equal to the amount of such reduction is, notwithstanding subsection (a),
transferred and made available for grants
pursuant to section 300ff–28(a)(1) of this
title, in addition to amounts available for
such grants under section 300ff–31b of this
title; and
(B) if a transfer under subparagraph
(A)(ii)(II) is made with respect to the metropolitan area for such first subsequent fiscal
year, then—
(i) the amount reserved under paragraph
(1)(A) or (2)(A) of subsection (b) of this section for such year is deemed to be reduced
by an additional $500,000; and
(ii) an amount equal to the amount of
such additional reduction is, notwithstanding subsection (a), transferred and
made available for grants pursuant to section 300ff–28(a)(1) of this title, in addition
to amounts available for such grants under
section 300ff–31b of this title.
(2) If a metropolitan area is a transitional
area under section 300ff–19 of this title for a
1 So

in original. Probably should be preceded by ‘‘section’’.

Page 1228

fiscal year, but for a subsequent fiscal year
ceases to be a transitional area by reason of
section 300ff–19(c)(2) of this title (and does not
qualify for such subsequent fiscal year as an
eligible area under subpart I)—
(A) the amount reserved under subsection
(b)(2)(B) of this section for the first such
subsequent fiscal year of not being a transitional area is deemed to be reduced by an
amount equal to the total of—
(i) the amount of the grant that, pursuant to section 300ff–13(a) of this title, was
made under section 300ff–19(d)(2)(A) of this
title for the metropolitan area for the preceding fiscal year; and
(ii) $500,000; and
(B)(i) subject to clause (ii), an amount
equal to the amount of the reduction under
subparagraph (A) for such year is, notwithstanding subsection (a), transferred and
made available for grants pursuant to section 300ff–28(a)(1) of this title, in addition to
amounts available for such grants under section 300ff–31b of this title; and
(ii) for each of fiscal years 2010 through
2013, notwithstanding subsection (a)—
(I) there shall be transferred to the State
containing the metropolitan area, for purposes described in section 300ff–22(a) of this
title, an amount (which shall not be taken
into
account
in
applying
section
300ff–28(a)(2)(H) of this title) equal to—
(aa) for the first fiscal year of the metropolitan area not being a transitional
area, 75 percent of the amount described
in subparagraph (A)(i) for such area;
(bb) for the second fiscal year of the
metropolitan area not being a transitional area, 50 percent of such amount;
and
(cc) for the third fiscal year of the
metropolitan area not being a transitional area, 25 percent of such amount;
and
(II) there shall be transferred and made
available for grants pursuant to section
300ff–28(a)(1) of this title for the fiscal
year, in addition to amounts available for
such grants under section 300ff–31b of this
title, an amount equal to the total amount
of the reduction for such fiscal year under
subparagraph (A), less the amount transferred for such fiscal year under subclause
(I).
(3) If a metropolitan area is a transitional
area under section 300ff–19 of this title for a
fiscal year, but for a subsequent fiscal year
qualifies as an eligible area under subpart I—
(A) the amount reserved under subsection
(b)(2)(B) of this section for the first such
subsequent fiscal year of becoming an eligible area is deemed to be reduced by an
amount equal to the amount of the grant
that, pursuant to section 300ff–13(a) of this
title,
was
made
under
section
300ff–19(d)(2)(A) of this title for the metropolitan area for the preceding fiscal year;
and
(B) the amount reserved under subsection
(b)(2)(A) for such fiscal year is deemed to be

Page 1229

TITLE 42—THE PUBLIC HEALTH AND WELFARE

increased by an amount equal to the amount
of the reduction under subparagraph (A) for
such year.
(d) Certain transfers; allocations between programs under subpart I
With respect to paragraphs (1)(B)(i) and
(2)(A)(ii) of subsection (c), the Secretary shall
administer any reductions under such paragraphs for a fiscal year in accordance with the
following:
(1) The reductions shall be made from
amounts available for the single program referred to in section 300ff–19(d)(2)(C) of this title
(relating to supplemental grants).
(2) The reductions shall be made before the
amounts referred to in paragraph (1) are used
for purposes of section 300ff–13(a)(4) of this
title.
(3) If the amounts referred to in paragraph
(1) are not sufficient for making all the reductions, the reductions shall be reduced until the
total amount of the reductions equals the
total of the amounts referred to in such paragraph.
(e) Rules of construction regarding first subsequent fiscal year
Paragraphs (1) and (2) of subsection (c) apply
with respect to each series of fiscal years during
which a metropolitan area is an eligible area
under subpart I or a transitional area under section 300ff–19 of this title for a fiscal year and
then for a subsequent fiscal year ceases to be
such an area by reason of section 300ff–11(b) or
300ff–19(c)(2) of this title, respectively, rather
than applying to a single such series. Paragraph
(3) of subsection (c) applies with respect to each
series of fiscal years during which a metropolitan area is a transitional area under section
300ff–19 of this title for a fiscal year and then for
a subsequent fiscal year becomes an eligible
area under subpart I, rather than applying to a
single such series.
(July 1, 1944, ch. 373, title XXVI, § 2610, as added
and amended Pub. L. 109–415, title I, § 108, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2783, 2820; Pub.
L. 111–87, §§ 2(a)(1), (3)(A), (b), 4(b), Oct. 30, 2009,
123 Stat. 2885, 2889.)
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a). Pub. L. 111–87, § 2(b), substituted
‘‘$649,500,000 for fiscal year 2009, $681,975,000 for fiscal
year 2010, $716,074,000 for fiscal year 2011, $751,877,000 for
fiscal year 2012, and $789,471,000 for fiscal year 2013’’ for
‘‘and $649,500,000 for fiscal year 2009’’.
Subsec. (c)(2)(B). Pub. L. 111–87, § 4(b), designated existing provisions as cl. (i), inserted ‘‘subject to clause
(ii),’’ before ‘‘an amount equal to the amount’’, and
added cl. (ii).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective

§ 300ff–21

Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 2(b) and 4(b) of Pub. L. 111–87 be applicable
to this section as so revived and effective as if enacted
on Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.

PART B—CARE GRANT PROGRAM
SUBPART I—GENERAL GRANT PROVISIONS

AMENDMENTS
1996—Pub. L. 104–146, § 7(b)(1), May 20, 1996, 110 Stat.
1368, added heading ‘‘SUBPART I—GENERAL GRANT PROVISIONS’’.

§ 300ff–21. Grants
The Secretary shall, subject to the availability of appropriations, make grants to States to
enable such States to improve the quality,
availability and organization of health care and
support services for individuals and families
with HIV/AIDS. The authority of the Secretary
to provide grants under this section is subject to
section 300ff–34(e)(2) 1 of this title (relating to
the decrease in perinatal transmission of HIV/
AIDS).
(July 1, 1944, ch. 373, title XXVI, § 2611, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 586; amended Pub. L. 104–146, §§ 3(c)(1),
7(b)(2), May 20, 1996, 110 Stat. 1353, 1368; Pub. L.
106–345, title II, § 201, Oct. 20, 2000, 114 Stat. 1329;
Pub. L. 109–415, title II, §§ 201(c)(1), 204(a), title
VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2788, 2796,
2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009,
123 Stat. 2885.)
REFERENCES IN TEXT
Section 300ff–34(e)(2) of this title, referred to in text,
was repealed by Pub. L. 106–345, title II, § 211(1), Oct. 20,
2000, 114 Stat. 1339.
PRIOR PROVISIONS
A prior section 2611 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238j of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ in two places.
Pub. L. 109–415, § 204(a), substituted ‘‘this section’’ for
‘‘this part’’.
Pub. L. 109–415, § 201(c)(1), struck out subsec. (a) designation and heading before ‘‘The Secretary’’ and
struck out subsec. (b) which related to priority for
women, infants, and children.
2000—Subsec. (b). Pub. L. 106–345 amended heading
and text of subsec. (b) generally. Prior to amendment,
text read as follows: ‘‘For the purpose of providing
health and support services to infants, children, and
women with HIV disease, including treatment measures
to prevent the perinatal transmission of HIV, a State
shall use, of the funds allocated under this part to the
State for a fiscal year, not less than the percentage
constituted by the ratio of the population in the State
1 See

References in Text note below.

§ 300ff–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of infants, children, and women with acquired immune
deficiency syndrome to the general population in the
State of individuals with such syndrome.’’
1996—Pub. L. 104–146, § 3(c)(1), designated existing provisions as subsec. (a), inserted heading, and added subsec. (b).
Subsec. (a). Pub. L. 104–146, § 7(b)(2), inserted at end
‘‘The authority of the Secretary to provide grants
under this part is subject to section 300ff–34(e)(2) of this
title (relating to the decrease in perinatal transmission
of HIV disease).’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–22. General use of grants
(a) In general
A State may use amounts provided under
grants made under section 300ff–21 of this title
for—
(1) core medical services described in subsection (b);
(2) support services described in subsection
(c); and
(3) administrative expenses described in section 300ff–28(b)(3) of this title.
(b) Required funding for core medical services
(1) In general
With respect to a grant under section
300ff–21 of this title for a State for a grant
year, the State shall, of the portion of the
grant remaining after reserving amounts for
purposes of subparagraphs (A) and (E)(ii)(I) of
section 300ff–28(b)(3) of this title, use not less
than 75 percent to provide core medical services that are needed in the State for individuals with HIV/AIDS who are identified and eligible under this subchapter (including services
regarding the co-occurring conditions of the
individuals).
(2) Waiver
(A) In general
The Secretary shall waive the application
of paragraph (1) with respect to a State for
a grant year if the Secretary determines
that, within the State—
(i) there are no waiting lists for AIDS
Drug Assistance Program services under
section 300ff–26 of this title; and
(ii) core medical services are available to
all individuals with HIV/AIDS identified
and eligible under this subchapter.
(B) Notification of waiver status
When informing a State that a grant under
section 300ff–21 of this title is being made to
the State for a fiscal year, the Secretary
shall inform the State whether a waiver
under subparagraph (A) is in effect for the
fiscal year.

Page 1230

(3) Core medical services
For purposes of this subsection, the term
‘‘core medical services’’, with respect to an individual infected with HIV/AIDS (including
the co-occurring conditions of the individual)
means the following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments in accordance with section 300ff–26 of
this title.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (d).
(F) Health insurance premium and cost
sharing assistance for low-income individuals in accordance with section 300ff–25 of
this title.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 300ff–24(c)
of this title.
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(c) Support services
(1) In general
For purposes of this subsection, the term
‘‘support services’’ means services, subject to
the approval of the Secretary, that are needed
for individuals with HIV/AIDS to achieve their
medical outcomes (such as respite care for persons caring for individuals with HIV/AIDS,
outreach services, medical transportation, linguistic services, and referrals for health care
and support services).
(2) Definition of medical outcomes
In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting the
HIV-related clinical status of an individual
with HIV/AIDS.
(d) Early intervention services
(1) In general
For purposes of this section, the term ‘‘early
intervention services’’ means HIV/AIDS early
intervention services described in section
300ff–51(e) of this title, with follow-up referral
provided for the purpose of facilitating the access of individuals receiving the services to
HIV-related health services. The entities
through which such services may be provided
under the grant include public health departments, emergency rooms, substance abuse and
mental health treatment programs, detoxification centers, detention facilities, clinics regarding sexually transmitted diseases, homeless shelters, HIV/AIDS counseling and testing
sites, health care points of entry specified by
States, federally qualified health centers, and
entities described in section 300ff–52(a) of this
title that constitute a point of access to services by maintaining referral relationships.
(2) Conditions
With respect to an entity that proposes to
provide early intervention services under

Page 1231

TITLE 42—THE PUBLIC HEALTH AND WELFARE

paragraph (1), such paragraph shall apply only
if the entity demonstrates to the satisfaction
of the chief elected official for the State involved that—
(A) Federal, State, or local funds are
otherwise inadequate for the early intervention services the entity proposes to provide;
and
(B) the entity will expend funds pursuant
to such subparagraph to supplement and not
supplant other funds available to the entity
for the provision of early intervention services for the fiscal year involved.
(e) Priority for women, infants, children, and
youth
(1) In general
For the purpose of providing health and support services to infants, children, youth, and
women with HIV/AIDS, including treatment
measures to prevent the perinatal transmission of HIV, a State shall for each of such
populations in the eligible area use, from the
grants made for the area under section
300ff–11(a) of this title for a fiscal year, not
less than the percentage constituted by the
ratio of the population involved (infants, children, youth, or women in such area) with HIV/
AIDS to the general population in such area of
individuals with HIV/AIDS.
(2) Waiver
With respect to the population involved, the
Secretary may provide to a State a waiver of
the requirement of paragraph (1) if such State
demonstrates to the satisfaction of the Secretary that the population is receiving HIV-related health services through the State medicaid program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], the State
children’s health insurance program under
title XXI of such Act [42 U.S.C. 1397aa et seq.],
or other Federal or State programs.
(f) Construction
A State may not use amounts received under
a grant awarded under section 300ff–21 of this
title to purchase or improve land, or to purchase, construct, or permanently improve (other
than minor remodeling) any building or other
facility, or to make cash payments to intended
recipients of services.
(July 1, 1944, ch. 373, title XXVI, § 2612, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 586; amended Pub. L. 104–146, § 3(c)(2), May
20, 1996, 110 Stat. 1354; Pub. L. 106–345, title II,
§ 202, title V, § 503(b), Oct. 20, 2000, 114 Stat. 1330,
1355; Pub. L. 109–415, title II, § 201(a), title VII,
§ 703, Dec. 19, 2006, 120 Stat. 2785, 2820; Pub. L.
111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (e)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XIX and
XXI of the Act are classified generally to subchapters
XIX (§ 1396 et seq.) and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.
CODIFICATION
Another section 3(c)(2) of Pub. L. 104–146 amended
section 300ff–23 of this title.

§ 300ff–23

PRIOR PROVISIONS
A prior section 2612 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238k of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009; Revival of Section note below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 201(a), reenacted section catchline
without change and amended text generally, substituting provisions relating to general use of grants, required funding for core medical services, support and
early intervention services, priority for women, infants, children, and youth, and prohibition against use
of amounts for real property improvement or to make
cash payments, for provisions relating to general use of
grants, support services and outreach, early intervention services, and establishment of a quality management program in each State.
2000—Pub. L. 106–345, § 202(1), designated existing provisions as subsec. (a) and inserted heading.
Subsec. (a)(1). Pub. L. 106–345, § 503(b), made technical
amendment to directory language of Pub. L. 104–146,
§ 3(c)(2)(A)(iii). See 1996 Amendment note below.
Subsec. (b) to (d). Pub. L. 106–345, § 202(2), added subsecs. (b) to (d).
1996—Pub. L. 104–146, § 3(c)(2)(A), as amended by Pub.
L. 106–345, § 503(b), struck out ‘‘(a) In general’’ before ‘‘A
State may use amounts’’, added par. (1), redesignated
former pars. (1) to (4) as (2) to (5), respectively, substituted ‘‘therapeutics to treat HIV disease’’ for ‘‘treatments, that have been determined to prolong life or
prevent serious deterioration of health,’’ in par. (5), and
inserted after par. (5) ‘‘Services described in paragraph
(1) shall be delivered through consortia designed as described in paragraph (2), where such consortia exist, unless the State demonstrates to the Secretary that delivery of such services would be more effective when
other delivery mechanisms are used. In making a determination regarding the delivery of services, the State
shall consult with appropriate representatives of service providers and recipients of services who would be
affected by such determination, and shall include in its
demonstration to the Secretary the findings of the
State regarding such consultation.’’
Subsec. (b). Pub. L. 104–146, § 3(c)(2)(B), struck out
heading and text of subsec. (b). Text read as follows: ‘‘A
State shall use not less than 15 percent of funds allocated under this part to provide health and support
services to infants, children, women, and families with
HIV disease.’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–23. Grants to establish HIV care consortia
(a) Consortia
A State may, subject to subsection (f), use
amounts provided under a grant awarded under
section 300ff–21 of this title to provide assistance
under section 300ff–22(a) of this title to an entity
that—

§ 300ff–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) is an association of one or more public,
and one or more nonprofit private,1 (or private
for-profit providers or organizations if such
entities are the only available providers of
quality HIV care in the area) 1 health care and
support service providers and community
based organizations operating within areas determined by the State to be most affected by
HIV/AIDS; and
(2) agrees to use such assistance for the planning, development and delivery, through the
direct provision of services or through entering into agreements with other entities for the
provision of such services, of comprehensive
outpatient health and support services for individuals with HIV/AIDS, that may include—
(A) essential health services such as case
management services, medical, nursing, substance abuse treatment, mental health
treatment, and dental care, diagnostics,
monitoring, prophylactic treatment for opportunistic infections, treatment education
to take place in the context of health care
delivery, and medical follow-up services,
mental health, developmental, and rehabilitation services, home health and hospice
care; and
(B) essential support services such as
transportation services, attendant care,
homemaker services, day or respite care,
benefits advocacy, advocacy services provided through public and nonprofit private
entities, and services that are incidental to
the provision of health care services for individuals with HIV/AIDS including nutrition
services, housing referral services, and child
welfare and family services (including foster
care and adoption services).
An entity or entities of the type described in
this subsection shall hereinafter be referred to
in this subchapter as a ‘‘consortium’’ or ‘‘consortia’’.
(b) Assurances
(1) Requirement
To receive assistance from a State under
subsection (a) of this section, an applicant
consortium shall provide the State with assurances that—
(A) within any locality in which such consortium is to operate, the populations and
subpopulations of individuals and families
with HIV/AIDS have been identified by the
consortium, particularly those experiencing
disparities in access and services and those
who reside in historically underserved communities;
(B) the service plan established under subsection (c)(2) of this section by such consortium is consistent with the comprehensive
plan under section 300ff–27(b)(4) of this title
and addresses the special care and service
needs of the populations and subpopulations
identified under subparagraph (A); and
(C) except as provided in paragraph (2), the
consortium will be a single coordinating entity that will integrate the delivery of services among the populations and subpopulations identified under subparagraph (A).
1 So in original. The comma probably should follow parenthetical phrase.

Page 1232

(2) Exception
Subparagraph (C) of paragraph (1) shall not
apply to any applicant consortium that the
State determines will operate in a community
or locality in which it has been demonstrated
by the applicant consortium that—
(A) subpopulations exist within the community to be served that have unique service requirements; and
(B) such unique service requirements cannot be adequately and efficiently addressed
by a single consortium serving the entire
community or locality.
(c) Application
(1) In general
To receive assistance from the State under
subsection (a) of this section, a consortium
shall prepare and submit to the State, an application that—
(A) demonstrates that the consortium includes agencies and community-based organizations—
(i) with a record of service to populations and subpopulations with HIV/AIDS
requiring care within the community to be
served; and
(ii) that are representative of populations and subpopulations reflecting the
local incidence of HIV and that are located
in areas in which such populations reside;
(B) demonstrates that the consortium has
carried out an assessment of service needs
within the geographic area to be served and,
after consultation with the entities described in paragraph (2), has established a
plan to ensure the delivery of services to
meet such identified needs that shall include—
(i) assurances that service needs will be
addressed through the coordination and
expansion of existing programs before new
programs are created;
(ii) assurances that, in metropolitan
areas, the geographic area to be served by
the consortium corresponds to the geographic boundaries of local health and support services delivery systems to the extent practicable;
(iii) assurances that, in the case of services for individuals residing in rural areas,
the applicant consortium shall deliver case
management services that link available
community support services to appropriate specialized medical services; and
(iv) assurances that the assessment of
service needs and the planning of the delivery of services will include participation
by individuals with HIV/AIDS;
(C) demonstrates that adequate planning
has occurred to meet the special needs of
families with HIV/AIDS, including family
centered and youth centered care;
(D) demonstrates that the consortium has
created a mechanism to evaluate periodically—
(i) the success of the consortium in responding to identified needs; and
(ii) the cost-effectiveness of the mechanisms employed by the consortium to deliver comprehensive care;

Page 1233

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(E) demonstrates that the consortium will
report to the State the results of the evaluations described in subparagraph (D) and
shall make available to the State or the Secretary, on request, such data and information on the program methodology that may
be required to perform an independent evaluation; and
(F) demonstrates that adequate planning
occurred to address disparities in access and
services and historically underserved communities.
(2) Consultation
In establishing the plan required under paragraph (1)(B), the consortium shall consult
with—
(A)(i) the public health agency that provides or supports ambulatory and outpatient
HIV-related health care services within the
geographic area to be served; or
(ii) in the case of a public health agency
that does not directly provide such HIV-related health care services such agency shall
consult with an entity or entities that directly provide ambulatory and outpatient
HIV-related health care services within the
geographic area to be served;
(B) not less than one community-based organization that is organized solely for the
purpose of providing HIV-related support
services to individuals with HIV/AIDS;
(C) grantees under section 300ff–71 of this
title, or, if none are operating in the area,
representatives in the area of organizations
with a history of serving children, youth,
women, and families living with HIV; and
(D) the types of entities described in section 300ff–12(b)(2) of this title.
The organization to be consulted under subparagraph (B) shall be at the discretion of the
applicant consortium.
(d) ‘‘Family centered care’’ defined
As used in section 300ff–21 of this title, the
term ‘‘family centered care’’ means the system
of services described in this section that is targeted specifically to the special needs of infants,
children, women, and families. Family centered
care shall be based on a partnership between
parents, professionals, and the community designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for children, women, and families
with HIV/AIDS.
(e) Priority
In providing assistance under subsection (a) of
this section, the State shall, among applicants
that meet the requirements of this section, give
priority—
(1) first to consortia that are receiving assistance from the Health Resources and Services Administration for adult and pediatric
HIV-related care demonstration projects; and
then
(2) to any other existing HIV care consortia.
(f) Allocation of funds; treatment as support
services
For purposes of the requirement of section
300ff–22(b)(1) of this title, expenditures of grants

§ 300ff–23

under section 300ff–21 of this title for or through
consortia under this section are deemed to be
support services, not core medical services. The
preceding sentence may not be construed as having any legal effect on the provisions of subsection (a) that relate to authorized expenditures of the grant.
(July 1, 1944, ch. 373, title XXVI, § 2613, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 586; amended Pub. L. 104–146, § 3(c)(2), May
20, 1996, 110 Stat. 1354; Pub. L. 106–345, title II,
§ 203, Oct. 20, 2000, 114 Stat. 1331; Pub. L. 109–415,
title II, §§ 201(b), 204(a), title VII, §§ 702(3), 703,
Dec. 19, 2006, 120 Stat. 2787, 2796, 2820; Pub. L.
111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
CODIFICATION
Another section 3(c)(2) of Pub. L. 104–146 amended
section 300ff–22 of this title.
PRIOR PROVISIONS
A prior section 2613 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238l of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ wherever appearing.
Subsec. (a). Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21 of this title’’ for ‘‘this part’’ in introductory provisions.
Pub. L. 109–415, § 201(b)(1), in introductory provisions
substituted ‘‘may, subject to subsection (f), use’’ for
‘‘may use’’ and ‘‘section 300ff–22(a) of this title’’ for
‘‘section 300ff–22(a)(1) of this title’’.
Subsec. (d). Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Subsec. (f). Pub. L. 109–415, § 201(b)(2), added subsec.
(f).
2000—Subsec. (b)(1)(A). Pub. L. 106–345, § 203(1)(A), inserted ‘‘, particularly those experiencing disparities in
access and services and those who reside in historically
underserved communities’’ before semicolon.
Subsec. (b)(1)(B). Pub. L. 106–345, § 203(1)(B), inserted
‘‘is consistent with the comprehensive plan under section 300ff–27(b)(4) of this title and’’ after ‘‘by such consortium’’.
Subsec. (c)(1)(F). Pub. L. 106–345, § 203(2), added subpar. (F).
Subsec. (c)(2)(D). Pub. L. 106–345, § 203(3), added subpar. (D).
1996—Subsec. (a)(1). Pub. L. 104–146, § 3(c)(2)(A)(i), inserted ‘‘(or private for-profit providers or organizations
if such entities are the only available providers of quality HIV care in the area)’’ after ‘‘nonprofit private,’’.
Subsec. (a)(2)(A). Pub. L. 104–146, § 3(c)(2)(A)(ii), inserted ‘‘substance abuse treatment, mental health
treatment,’’ after ‘‘nursing,’’ and ‘‘prophylactic treatment for opportunistic infections, treatment education
to take place in the context of health care delivery,’’
after ‘‘monitoring,’’.
Subsec. (c)(1)(C). Pub. L. 104–146, § 3(c)(2)(B)(i), inserted ‘‘and youth centered’’ after ‘‘family centered’’.
Subsec. (c)(2)(C). Pub. L. 104–146, § 3(c)(2)(B)(ii), added
subpar. (C).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective

§ 300ff–24

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–24. Grants for home- and communitybased care
(a) Uses
A State may use amounts provided under a
grant awarded under section 300ff–21 of this title
to make grants under section 300ff–22(b)(3)(J) of
this title to entities to—
(1) provide home- and community-based
health services for individuals with HIV/AIDS
pursuant to written plans of care prepared by
a case management team, that shall include
appropriate health care professionals, in such
State for providing such services to such individuals;
(2) provide outreach services to individuals
with HIV/AIDS, including those individuals in
rural areas; and
(3) provide for the coordination of the provision of services under this section with the
provision of HIV-related health services, including specialty care and vaccinations for
hepatitis co-infection, provided by public and
private entities.
(b) Priority
In awarding grants under subsection (a) of this
section, a State shall give priority to entities
that provide assurances to the State that—
(1) such entities will participate in HIV care
consortia if such consortia exist within the
State; and
(2) such entities will utilize amounts provided under such grants for the provision of
home- and community-based services to lowincome individuals with HIV/AIDS.
(c) ‘‘Home- and community-based health services’’ defined
As used in section 300ff–21 of this title, the
term ‘‘home- and community-based health services’’—
(1) means, with respect to an individual with
HIV/AIDS, skilled health services furnished to
the individual in the individual’s home pursuant to a written plan of care established by a
case management team, that shall include appropriate health care professionals, for the
provision of such services and items described
in paragraph (2);
(2) includes—
(A) durable medical equipment;
(B) home health aide services and personal
care services furnished in the home of the
individual;
(C) day treatment or other partial hospitalization services;
(D) home intravenous and aerosolized drug
therapy (including prescription drugs administered as part of such therapy);
(E) routine diagnostic testing administered in the home of the individual; and
(F) appropriate mental health, developmental, and rehabilitation services; and

Page 1234

(3) does not include—
(A) inpatient hospital services; and
(B) nursing home and other long term care
facilities.
(July 1, 1944, ch. 373, title XXVI, § 2614, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 589; amended Pub. L. 109–415, title II,
§§ 201(c)(2), 204(a), (b), title VII, §§ 702(3), 703, Dec.
19, 2006, 120 Stat. 2788, 2796, 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
PRIOR PROVISIONS
A prior section 2614 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238m of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ wherever appearing.
Subsec. (a). Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21 of this title’’ for ‘‘this part’’ in introductory provisions.
Pub. L. 109–415, § 201(c)(2)(A), substituted ‘‘section
300ff–22(b)(3)(J) of this title’’ for ‘‘section 300ff–22(a)(2)
of this title’’ in introductory provisions.
Subsec. (a)(3). Pub. L. 109–415, § 204(b), inserted
‘‘, including specialty care and vaccinations for hepatitis co-infection,’’ after ‘‘health services’’.
Subsec. (c). Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21 of this title’’ for ‘‘this part’’ in introductory provisions.
Subsec. (c)(2)(B). Pub. L. 109–415, § 201(c)(2)(B), struck
out ‘‘homemaker or’’ before ‘‘home health’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–25. Continuum of health insurance coverage
(a) In general
A State may use amounts received under a
grant awarded under section 300ff–21 of this title
to establish a program of financial assistance
under section 300ff–22(b)(3)(F) of this title to assist eligible low-income individuals with HIV/
AIDS in—
(1) maintaining a continuity of health insurance; or
(2) receiving medical benefits under a health
insurance program, including risk-pools.
(b) Limitations
Assistance shall not be utilized under subsection (a) of this section—
(1) to pay any costs associated with the creation, capitalization, or administration of a liability risk pool (other than those costs paid
on behalf of individuals as part of premium
contributions to existing liability risk pools);
and

Page 1235

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) to pay any amount expended by a State
under title XIX of the Social Security Act [42
U.S.C. 1396 et seq.].
(July 1, 1944, ch. 373, title XXVI, § 2615, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 590; amended Pub. L. 109–415, title II,
§§ 201(c)(3), 204(a), title VII, §§ 702(3), 703, Dec. 19,
2006, 120 Stat. 2788, 2796, 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XIX of the
Social Security Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a). Pub. L. 109–415, §§ 201(c)(3), 204(a), 702(3),
in introductory provisions, substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’, ‘‘section 300ff–21 of this title’’ for ‘‘this
part’’, and ‘‘section 300ff–22(b)(3)(F) of this title’’ for
‘‘section 300ff–22(a)(3) of this title’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–26. Provision of treatments
(a) In general
A State shall use a portion of the amounts
provided under a grant awarded under section
300ff–21 of this title to establish a program under
section 300ff–22(b)(3)(B) of this title to provide
therapeutics to treat HIV/AIDS or prevent the
serious deterioration of health arising from HIV/
AIDS in eligible individuals, including measures
for the prevention and treatment of opportunistic infections.
(b) Eligible individual
To be eligible to receive assistance from a
State under this section an individual shall—
(1) have a medical diagnosis of HIV/AIDS;
and
(2) be a low-income individual, as defined by
the State.
(c) State duties
In carrying out this section the State shall—
(1) ensure that the therapeutics included on
the list of classes of core antiretroviral therapeutics established by the Secretary under
subsection (e) are, at a minimum, the treatments provided by the State pursuant to this
section;
(2) provide assistance for the purchase of
treatments determined to be eligible under
paragraph (1), and the provision of such ancil-

§ 300ff–26

lary devices that are essential to administer
such treatments;
(3) provide outreach to individuals with HIV/
AIDS, and as appropriate to the families of
such individuals;
(4) facilitate access to treatments for such
individuals;
(5) document the progress made in making
therapeutics described in subsection (a) of this
section available to individuals eligible for assistance under this section; and
(6) encourage, support, and enhance adherence to and compliance with treatment regimens, including related medical monitoring.
Of the amount reserved by a State for a fiscal
year for use under this section, the State may
not use more than 5 percent to carry out services under paragraph (6), except that the percentage applicable with respect to such paragraph is 10 percent if the State demonstrates to
the Secretary that such additional services are
essential and in no way diminish access to the
therapeutics described in subsection (a) of this
section.
(d) Duties of Secretary
In carrying out this section, the Secretary
shall review the current status of State drug reimbursement programs established under section 300ff–22(2) 1 of this title and assess barriers
to the expanded availability of the treatments
described in subsection (a) of this section. The
Secretary shall also examine the extent to
which States coordinate with other grantees
under this subchapter to reduce barriers to the
expanded availability of the treatments described in subsection (a) of this section.
(e) List of classes of core antiretroviral therapeutics
For purposes of subsection (c)(1), the Secretary shall develop and maintain a list of classes of core antiretroviral therapeutics, which list
shall be based on the therapeutics included in
the guidelines of the Secretary known as the
Clinical Practice Guidelines for Use of HIV/AIDS
Drugs, relating to drugs needed to manage
symptoms associated with HIV. The preceding
sentence does not affect the authority of the
Secretary to modify such Guidelines.
(f) Use of health insurance and plans
(1) In general
In carrying out subsection (a) of this section, a State may expend a grant under section 300ff–21 of this title to provide the therapeutics described in such subsection by paying
on behalf of individuals with HIV/AIDS the
costs of purchasing or maintaining health insurance or plans whose coverage includes a
full range of such therapeutics and appropriate primary care services.
(2) Limitation
The authority established in paragraph (1)
applies only to the extent that, for the fiscal
year involved, the costs of the health insurance or plans to be purchased or maintained
under such paragraph do not exceed the costs
1 See

References in Text note below.

§ 300ff–27

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of otherwise providing therapeutics described
in subsection (a) of this section.
(g) Drug rebate program
A State shall ensure that any drug rebates received on drugs purchased from funds provided
pursuant to this section are applied to activities
supported under this subpart, with priority
given to activities described under this section.
(July 1, 1944, ch. 373, title XXVI, § 2616, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 590; amended Pub. L. 104–146, § 3(c)(3), May
20, 1996, 110 Stat. 1355; Pub. L. 106–345, title II,
§ 204, Oct. 20, 2000, 114 Stat. 1332; Pub. L. 109–415,
title II, §§ 201(c)(4), 202, 204(a), title VII, §§ 702(3),
703, Dec. 19, 2006, 120 Stat. 2788, 2796, 2820; Pub. L.
111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
Section 300ff–22 of this title, referred to in subsec. (d),
was amended generally by Pub. L. 109–415, title II,
§ 201(a), Dec. 19, 2006, 120 Stat. 2785, and, as so amended,
does not contain a par. (2).
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a). Pub. L. 109–415, § 702(3), substituted ‘‘HIV/
AIDS’’ for ‘‘HIV disease’’ in two places.
Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21
of this title’’ for ‘‘this part’’.
Pub. L. 109–415, § 201(c)(4), substituted ‘‘section
300ff–22(b)(3)(B) of this title’’ for ‘‘section 300ff–22(a)(5)
of this title’’.
Subsec. (b)(1). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Subsec. (c)(1). Pub. L. 109–415, § 202(a)(1), added par. (1)
and struck out former par. (1) which read as follows:
‘‘determine, in accordance with guidelines issued by
the Secretary, which treatments are eligible to be included under the program established under this section;’’.
Subsec. (c)(3). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Subsec. (e). Pub. L. 109–415, § 202(a)(3), added subsec.
(e). Former subsec. (e) redesignated (f).
Subsec. (f). Pub. L. 109–415, § 202(a)(2), redesignated
subsec. (e) as (f).
Subsec. (f)(1). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21
of this title’’ for ‘‘this part’’.
Subsec. (g). Pub. L. 109–415, § 202(b), added subsec. (g).
2000—Subsec. (c). Pub. L. 106–345, § 204(a), added par.
(6) and concluding provisions.
Subsec. (e). Pub. L. 106–345, § 204(b), added subsec. (e).
1996—Subsec. (a). Pub. L. 104–146, § 3(c)(3)(A), substituted ‘‘shall use a portion of the amounts’’ for ‘‘may
use amounts’’ and ‘‘section 300ff–22(a)(5) of this title to
provide therapeutics to treat HIV disease’’ for ‘‘section
300ff–22(a)(4) of this title to provide treatments that
have been determined to prolong life’’ and inserted before period ‘‘, including measures for the prevention
and treatment of opportunistic infections’’.
Subsec. (c)(5). Pub. L. 104–146, § 3(c)(3)(B), added par.
(5).
Subsec. (d). Pub. L. 104–146, § 3(c)(3)(C), added subsec.
(d).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective

Page 1236

Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–27. State application
(a) In general
The Secretary shall not make a grant to a
State under section 300ff–21 of this title for a fiscal year unless the State prepares and submits,
to the Secretary, an application at such time, in
such form, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out section
300ff–21 of this title.
(b) Description of intended uses and agreements
The application submitted under subsection
(a) of this section shall contain—
(1) a detailed description of the HIV-related
services provided in the State to individuals
and families with HIV/AIDS during the year
preceding the year for which the grant is requested, and the number of individuals and
families receiving such services, that shall include—
(A) a description of the types of programs
operated or funded by the State for the provision of HIV-related services during the
year preceding the year for which the grant
is requested and the methods utilized by the
State to finance such programs;
(B) an accounting of the amount of funds
that the State has expended for such services and programs during the year preceding
the year for which the grant is requested;
and
(C) information concerning—
(i) the number of individuals to be served
with assistance provided under the grant;
(ii) demographic data on the population
of the individuals to be served;
(iii) the average cost of providing each
category of HIV-related health services
and the extent to which such cost is paid
by third-party payors; and
(iv) the aggregate amounts expended for
each such category of services;
(2) a determination of the size and demographics of the population of individuals with
HIV/AIDS in the State;
(3) a determination of the needs of such population, with particular attention to—
(A) individuals with HIV/AIDS who know
their HIV status and are not receiving HIVrelated services; and
(B) disparities in access and services
among affected subpopulations and historically underserved communities;
(4) the designation of a lead State agency
that shall—
(A) administer all assistance received
under this part;
(B) conduct the needs assessment and prepare the State plan under paragraph (3);
(C) prepare all applications for assistance
under this part;

Page 1237

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) receive notices with respect to programs under this subchapter;
(E) every 2 years, collect and submit to the
Secretary all audits, consistent with Office
of Management and Budget circular A133,
from grantees within the State, including
audits regarding funds expended in accordance with this part; and
(F) carry out any other duties determined
appropriate by the Secretary to facilitate
the coordination of programs under this subchapter.1
(5) a comprehensive plan that describes the
organization and delivery of HIV health care
and support services to be funded with assistance received under section 300ff–21 of this
title that shall include a description of the
purposes for which the State intends to use
such assistance, and that—
(A) establishes priorities for the allocation
of funds within the State based on—
(i) size and demographics of the population of individuals with HIV/AIDS (as determined under paragraph (2)) and the
needs of such population (as determined
under paragraph (3));
(ii) availability of other governmental
and non-governmental resources, including
the State medicaid plan under title XIX of
the Social Security Act [42 U.S.C. 1396 et
seq.] and the State Children’s Health Insurance Program under title XXI of such
Act [42 U.S.C. 1397aa et seq.] to cover
health care costs of eligible individuals
and families with HIV/AIDS;
(iii) capacity development needs resulting from disparities in the availability of
HIV-related services in historically underserved communities and rural communities; and
(iv) the efficiency of the administrative
mechanism of the State for rapidly allocating funds to the areas of greatest need
within the State;
(B) includes a strategy for identifying individuals who know their HIV status and are
not receiving such services and for informing the individuals of and enabling the individuals to utilize the services, giving particular attention to eliminating disparities
in access and services among affected subpopulations and historically underserved
communities, and including discrete goals, a
timetable, and an appropriate allocation of
funds;
(C) includes a strategy to coordinate the
provision of such services with programs for
HIV prevention (including outreach and
early intervention) and for the prevention
and treatment of substance abuse (including
programs that provide comprehensive treatment services for such abuse);
(D) describes the services and activities to
be provided and an explanation of the manner in which the elements of the program to
be implemented by the State with such assistance will maximize the quality of health
and support services available to individuals
with HIV/AIDS throughout the State;
1 So

in original. The period probably should be a semicolon.

§ 300ff–27

(E) provides a description of the manner in
which services funded with assistance provided under section 300ff–21 of this title will
be coordinated with other available related
services for individuals with HIV/AIDS;
(F) provides a description of how the allocation and utilization of resources are consistent with the statewide coordinated statement of need (including traditionally underserved populations and subpopulations) developed in partnership with other grantees
in the State that receive funding under this
subchapter; and
(G) includes key outcomes to be measured
by all entities in the State receiving assistance under this subchapter; and 2
(6) an assurance that the public health agency administering the grant for the State will
periodically convene a meeting of individuals
with HIV/AIDS, members of a Federally recognized Indian tribe as represented in the State,
representatives of grantees under each part
under this subchapter, providers, and public
agency representatives for the purpose of developing a statewide coordinated statement of
need;
(7) an assurance by the State that—
(A) the public health agency that is administering the grant for the State engages
in a public advisory planning process, including public hearings, that includes the
participants under paragraph (6), and the
types of entities described in section
300ff–12(b)(2) of this title, in developing the
comprehensive plan under paragraph (5) and
commenting on the implementation of such
plan;
(B) the State will—
(i) to the maximum extent practicable,
ensure that HIV-related health care and
support services delivered pursuant to a
program established with assistance provided under section 300ff–21 of this title
will be provided without regard to the
ability of the individual to pay for such
services and without regard to the current
or past health condition of the individual
with HIV/AIDS;
(ii) ensure that such services will be provided in a setting that is accessible to lowincome individuals with HIV/AIDS;
(iii) provide outreach to low-income individuals with HIV/AIDS to inform such individuals of the services available under
section 300ff–21 of this title; and
(iv) in the case of a State that intends to
use amounts provided under the grant for
purposes described in section 300ff–25 of
this title, submit a plan to the Secretary
that demonstrates that the State has established a program that assures that—
(I) such amounts will be targeted to individuals who would not otherwise be
able to afford health insurance coverage;
and
(II) income, asset, and medical expense
criteria will be established and applied
by the State to identify those individ2 So

in original. The word ‘‘and’’ probably should not appear.

§ 300ff–27

TITLE 42—THE PUBLIC HEALTH AND WELFARE

uals who qualify for assistance under
such program, and information concerning such criteria shall be made available
to the public;
(C) the State will provide for periodic independent peer review to assess the quality
and appropriateness of health and support
services provided by entities that receive
funds from the State under section 300ff–21
of this title;
(D) the State will permit and cooperate
with any Federal investigations undertaken
regarding programs conducted under section
300ff–21 of this title;
(E) the State will maintain HIV-related
activities at a level that is equal to not less
than the level of such expenditures by the
State for the 1-year period preceding the fiscal year for which the State is applying to
receive a grant under section 300ff–21 of this
title;
(F) the State will ensure that grant funds
are not utilized to make payments for any
item or service to the extent that payment
has been made, or can reasonably be expected to be made, with respect to that item
or service—
(i) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program; or
(ii) by an entity that provides health
services on a prepaid basis (except for a
program administered by or providing the
services of the Indian Health Service); and
(G) entities within areas in which activities under the grant are carried out will
maintain appropriate relationships with entities in the area served that constitute key
points of access to the health care system
for individuals with HIV/AIDS (including
emergency rooms, substance abuse treatment programs, detoxification centers, adult
and juvenile detention facilities, sexually
transmitted disease clinics, HIV counseling
and testing sites, mental health programs,
and homeless shelters), and other entities
under section 3 300ff–22(c) and 300ff–52(a) of
this title, for the purpose of facilitating
early intervention for individuals newly diagnosed with HIV/AIDS and individuals
knowledgeable of their HIV status but not in
care; and
(8) a comprehensive plan—
(A) containing an identification of individuals with HIV/AIDS as described in clauses
(i) through (iii) of section 300ff–13(b)(2)(A) of
this title and the strategy required under
section 300ff–12(b)(4)(D)(iv) of this title;
(B) describing the estimated number of individuals within the State with HIV/AIDS
who do not know their status;
(C) describing activities undertaken by the
State to find the individuals described in
subparagraph (A) and to make such individuals aware of their status;
(D) describing the manner in which the
State will provide undiagnosed individuals
3 So

in original. Probably should be ‘‘sections’’.

Page 1238

who are made aware of their status with access to medical treatment for their HIV/
AIDS; and
(E) describing efforts to remove legal barriers, including State laws and regulations,
to routine testing.
(c) Requirements regarding imposition of
charges for services
(1) In general
The Secretary may not make a grant under
section 300ff–21 of this title to a State unless
the State provides assurances that in the provision of services with assistance provided
under the grant—
(A) in the case of individuals with an income less than or equal to 100 percent of the
official poverty line, the provider will not
impose charges on any such individual for
the provision of services under the grant;
(B) in the case of individuals with an income greater than 100 percent of the official
poverty line, the provider—
(i) will impose charges on each such individual for the provision of such services;
and
(ii) will impose charges according to a
schedule of charges that is made available
to the public;
(C) in the case of individuals with an income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an
amount exceeding 5 percent of the annual
gross income of the individual involved;
(D) in the case of individuals with an income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an
amount exceeding 7 percent of the annual
gross income of the individual involved; and
(E) in the case of individuals with an income greater than 300 percent of the official
poverty line, the provider will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income of the individual involved.
(2) Assessment of charge
With respect to compliance with the assurance made under paragraph (1), a grantee
under section 300ff–21 of this title may, in the
case of individuals subject to a charge for purposes of such paragraph—
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules regarding limitation on the maximum amount of
charges; and
(B) take into consideration the medical expenses of individuals in assessing the
amount of the charge, subject to such provisions.
(3) Applicability of limitation on amount of
charge
The Secretary may not make a grant under
section 300ff–21 of this title unless the appli-

Page 1239

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cant of the grant agrees that the limitations
established in subparagraphs (C), (D), and (E)
of paragraph (1) regarding the imposition of
charges for services applies to the annual aggregate of charges imposed for such services,
without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance,
or other charges.
(4) Waiver
(A) In general
The State shall waive the requirements established in paragraphs (1) through (3) in the
case of an entity that does not, in providing
health care services, impose a charge or accept reimbursement from any third-party
payor, including reimbursement under any
insurance policy or under any Federal or
State health benefits program.
(B) Determination
A determination by the State of whether
an entity referred to in subparagraph (A)
meets the criteria for a waiver under such
subparagraph shall be made without regard
to whether the entity accepts voluntary donations regarding the provision of services
to the public.
(d) Requirement of matching funds regarding
State allotments
(1) In general
In the case of any State to which the criterion described in paragraph (3) applies, the
Secretary may not make a grant under section
300ff–21 of this title unless the State agrees
that, with respect to the costs to be incurred
by the State in carrying out the program for
which the grant was awarded, the State will,
subject to subsection (b)(2) 4 of this section,
make available (directly or through donations
from public or private entities) non-Federal
contributions toward such costs in an amount
equal to—
(A) for the first fiscal year of payments
under the grant, not less than 162⁄3 percent of
such costs ($1 for each $5 of Federal funds
provided in the grant);
(B) for any second fiscal year of such payments, not less than 20 percent of such costs
($1 for each $4 of Federal funds provided in
the grant);
(C) for any third fiscal year of such payments, not less than 25 percent of such costs
($1 for each $3 of Federal funds provided in
the grant);
(D) for any fourth fiscal year of such payments, not less than 331⁄3 percent of such
costs ($1 for each $2 of Federal funds provided in the grant); and
(E) for any subsequent fiscal year of such
payments, not less than 331⁄3 percent of such
costs ($1 for each $2 of Federal funds provided in the grant).
(2) Determination of amount of non-Federal
contribution
(A) In general
Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fair4 See

References in Text note below.

§ 300ff–27

ly evaluated, including plant, equipment, or
services. Amounts provided by the Federal
Government, and any portion of any service
subsidized by the Federal Government, may
not be included in determining the amount
of such non-Federal contributions.
(B) Inclusion of certain amounts
(i) In making a determination of the
amount of non-Federal contributions made
by a State for purposes of paragraph (1), the
Secretary shall, subject to clause (ii), include any non-Federal contributions provided by the State for HIV-related services,
without regard to whether the contributions
are made for programs established pursuant
to this subchapter;
(ii) In making a determination for purposes of clause (i), the Secretary may not include any non-Federal contributions provided by the State as a condition of receiving Federal funds under any program under
this subchapter (except for the program established in section 300ff–21 of this title) or
under other provisions of law.
(3) Applicability of requirement
(A) Number of cases
A State referred to in paragraph (1) is any
State for which the number of cases of HIV/
AIDS reported to and confirmed by the Director of the Centers for Disease Control and
Prevention for the period described in subparagraph (B) constitutes in excess of 1 percent of the aggregate number of such cases
reported to and confirmed by the Director
for such period for the United States.
(B) Period of time
The period referred to in subparagraph (A)
is the 2-year period preceding the fiscal year
for which the State involved is applying to
receive a grant under subsection (a) of this
section.
(C) Puerto Rico
For purposes of paragraph (1), the number
of cases of HIV/AIDS reported and confirmed
for the Commonwealth of Puerto Rico for
any fiscal year shall be deemed to be less
than 1 percent.
(4) Diminished State contribution
With respect to a State that does not make
available the entire amount of the non-Federal contribution referred to in paragraph (1),
the State shall continue to be eligible to receive Federal funds under a grant under section 300ff–21 of this title, except that the Secretary in providing Federal funds under the
grant shall provide such funds (in accordance
with the ratios prescribed in paragraph (1))
only with respect to the amount of funds contributed by such State.
(July 1, 1944, ch. 373, title XXVI, § 2617, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 590; amended Pub. L. 102–531, title III,
§ 312(d)(29), Oct. 27, 1992, 106 Stat. 3506; Pub. L.
104–146, §§ 3(c)(4), 12(c)(3), May 20, 1996, 110 Stat.
1355, 1373; Pub. L. 106–345, title II, § 205, Oct. 20,
2000, 114 Stat. 1332; Pub. L. 109–415, title II,
§ 204(a), (c), (d), title VII, §§ 702(3), 703, Dec. 19,

§ 300ff–27a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2006, 120 Stat. 2796, 2797, 2820; Pub. L. 111–87,
§§ 2(a)(1), (3)(A), 9, Oct. 30, 2009, 123 Stat. 2885,
2895.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(b)(5)(A)(ii), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.
Titles XIX and XXI of the Act are classified generally
to subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.
Subsection (b)(2) of this section, referred to in subsec.
(d)(1), was redesignated subsec. (b)(4) by Pub. L. 106–345,
title II, § 205(a)(1), Oct. 20, 2000, 114 Stat. 1332, and then
subsec. (b)(5) by Pub. L. 109–415, title II, § 204(c)(2), Dec.
19, 2006, 120 Stat. 2796.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (b)(8). Pub. L. 111–87, § 9, added par. (8).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept, 30, 2009.
Pub. L. 109–415, § 204(a), substituted ‘‘section 300ff–21
of this title’’ for ‘‘this part’’ wherever appearing in subsecs. (a), (b), (c)(2), and (d).
Subsec. (b). Pub. L. 109–415, § 702(3), substituted ‘‘HIV/
AIDS’’ for ‘‘HIV disease’’ wherever appearing.
Subsec. (b)(4). Pub. L. 109–415, § 204(c)(1)(B), added par.
(4). Former par. (4) redesignated (5).
Subsec. (b)(5). Pub. L. 109–415, § 204(c)(1)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).
Subsec. (b)(5)(G). Pub. L. 109–415, § 204(c)(1)(C), added
subpar. (G).
Subsec. (b)(6). Pub. L. 109–415, § 204(c)(2), inserted
‘‘members of a Federally recognized Indian tribe as represented in the State,’’ before ‘‘representatives of
grantees’’.
Pub. L. 109–415, § 204(c)(1)(A), redesignated par. (5) as
(6). Former par. (6) redesignated (7).
Subsec. (b)(7). Pub. L. 109–415, § 204(c)(1)(A), redesignated par. (6) as (7).
Subsec. (b)(7)(A). Pub. L. 109–415, § 204(c)(1)(D), substituted ‘‘paragraph (6)’’ for ‘‘paragraph (5)’’ and ‘‘paragraph (5)’’ for ‘‘paragraph (4)’’.
Subsec. (b)(7)(F)(ii). Pub. L. 109–415, § 204(c)(3), inserted ‘‘(except for a program administered by or providing the services of the Indian Health Service)’’ before semicolon.
Subsec. (d)(3)(A), (C). Pub. L. 109–415, § 204(d), substituted ‘‘HIV/AIDS’’ for ‘‘acquired immune deficiency
syndrome’’.
2000—Subsec. (b)(2), (3). Pub. L. 106–345, § 205(a)(2),
added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.
Subsec. (b)(4). Pub. L. 106–345, § 205(a)(3)(A), (B), in introductory provisions substituted ‘‘comprehensive plan
that describes the organization’’ for ‘‘comprehensive
plan for the organization’’ and ‘‘, and that—’’ for
‘‘, including—’’.
Pub. L. 106–345, § 205(a)(1), redesignated par. (2) as (4).
Former par. (4) redesignated (6).
Subsec. (b)(4)(A) to (C). Pub. L. 106–345, § 205(a)(3)(D),
which directed the amendment of par. (4) by adding
subpars. (A) to (C) ‘‘before subparagraph (C)’’, was executed by adding them before subpar. (D), to reflect the
probable intent of Congress. Former subpars. (A) to (C)
redesignated (D) to (F), respectively.
Subsec. (b)(4)(D). Pub. L. 106–345, § 205(a)(3)(C), (E), redesignated subpar. (A) as (D) and inserted ‘‘describes’’
before ‘‘the services and activities’’.
Subsec. (b)(4)(E). Pub. L. 106–345, § 205(a)(3)(C), (F), redesignated subpar. (B) as (E) and inserted ‘‘provides’’
before ‘‘a description’’.

Page 1240

Subsec. (b)(4)(F). Pub. L. 106–345, § 205(a)(3)(C), (G), redesignated subpar. (C) as (F) and inserted ‘‘provides’’
before ‘‘a description’’.
Subsec. (b)(5). Pub. L. 106–345, § 205(a)(1), (b)(1), redesignated par. (3) as (5) and substituted ‘‘HIV disease’’ for
‘‘HIV’’.
Subsec. (b)(6). Pub. L. 106–345, § 205(a)(1), redesignated
par. (4) as (6).
Subsec. (b)(6)(A). Pub. L. 106–345, § 205(b)(2), amended
subpar. (A) generally. Prior to amendment, subpar. (A)
read as follows: ‘‘the public health agency that is administering the grant for the State will conduct public
hearings concerning the proposed use and distribution
of the assistance to be received under this part;’’.
Subsec. (b)(6)(G). Pub. L. 106–345, § 205(c), added subpar. (G).
1996—Subsec. (b)(2)(C). Pub. L. 104–146, § 3(c)(4)(A),
added subpar. (C).
Subsec. (b)(3). Pub. L. 104–146, § 3(c)(4)(C), added par.
(3). Former par. (3) redesignated (4).
Subsec. (b)(4). Pub. L. 104–146, § 3(c)(4)(B), redesignated par. (3) as (4).
Subsec. (b)(4)(B)(iv). Pub. L. 104–146, § 12(c)(3), which
directed amendment of par. (3)(B)(iv) by inserting ‘‘section’’ before ‘‘300ff–25’’, was executed by making the
amendment in par. (4)(B)(iv) to reflect the probable intent of Congress and the redesignation of par. (3) as (4)
by Pub. L. 104–146, § 3(c)(4)(B). See above.
1992—Subsec. (d)(3)(A). Pub. L. 102–531 substituted
‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 9 of Pub. L. 111–87 be applicable to this section as so revived and effective as if enacted on Sept.
30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87, set out
as a note under section 300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–27a. Spousal notification
(a) In general
The Secretary of Health and Human Services
shall not make a grant under part B of title
XXVI of the Public Health Service Act (42 U.S.C.
300ff–21 et seq.) to any State unless such State
takes administrative or legislative action to require that a good faith effort be made to notify
a spouse of a known HIV-infected patient that
such spouse may have been exposed to the
human immunodeficiency virus and should seek
testing.
(b) Definitions
For purposes of this section:
(1) Spouse
The term ‘‘spouse’’ means any individual
who is the marriage partner of an HIV-infected patient, or who has been the marriage
partner of that patient at any time within the
10-year period prior to the diagnosis of HIV infection.
(2) HIV-infected patient
The term ‘‘HIV-infected patient’’ means any
individual who has been diagnosed to be infected with the human immunodeficiency
virus.

Page 1241

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) State
The term ‘‘State’’ means any of the 50
States, the District of Columbia, or any territory of the United States.
(Pub. L. 104–146, § 8, May 20, 1996, 110 Stat. 1372.)
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec.
(a), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended.
Part B of title XXVI of the Act is classified generally
to this part. For complete classification of this Act to
the Code, see Short Title note set out under section 201
of this title and Tables.
CODIFICATION
Section was enacted as part of the Ryan White CARE
Act Amendments of 1996, and not as part of the Public
Health Service Act which comprises this chapter.
EFFECTIVE DATE
Section effective Oct. 1, 1996, see section 13 of Pub. L.
104–146, set out as an Effective Date of 1996 Amendment
note under section 300ff–11 of this title.

§ 300ff–28. Distribution of funds
(a) Amount of grant to State
(1) Minimum allotment
Subject to the extent of amounts made
available under section 300ff–31b of this title,
the amount of a grant to be made under section 300ff–21 of this title for—
(A) each of the 50 States, the District of
Columbia, Guam, and the Virgin Islands (referred to in this paragraph as a ‘‘covered
State’’) for a fiscal year shall be the greater
of—
(i)(I) with respect to a covered State
that has less than 90 living cases of AIDS,
as determined under paragraph (2)(D),
$200,000; or
(II) with respect to a covered State that
has 90 or more living cases of AIDS, as determined under paragraph (2)(D), $500,000;
and
(ii) an amount determined under paragraph (2) and then, as applicable, increased
under paragraph (2)(H); and
(B) each territory other than Guam and
the Virgin Islands shall be the greater of
$50,000 or an amount determined under paragraph (2).
(2) Determination
(A) Formula
For purposes of paragraph (1), the amount
referred to in this paragraph for a State (including a territory) for a fiscal year is, subject to subparagraphs (E) and (F)—
(i) an amount equal to the amount made
available under section 300ff–31b of this
title for the fiscal year involved for grants
pursuant to paragraph (1), subject to subparagraph (F); and
(ii) the percentage constituted by the
sum of—
(I) the product of 0.75 and the ratio of
the State distribution factor for the
State or territory (as determined under
subsection (B)) to the sum of the respective State distribution factors for all
States or territories;

§ 300ff–28

(II) the product of .20 and the ratio of
the non-EMA distribution factor for the
State or territory (as determined under
subparagraph (C)) to the sum of the respective non-EMA distribution factors
for all States or territories; and
(III) if the State does not for such fiscal year contain any area that is an eligible area under subpart I of part A or
any area that is a transitional area
under section 300ff–19 of this title (referred to in this subclause as a ‘‘no-EMA
State’’), the product of 0.05 and the ratio
of the number of cases that applies for
the State under subparagraph (D) to the
sum of the respective numbers of cases
that so apply for all no-EMA States.
(B) State distribution factor
For purposes of subparagraph (A)(ii)(I), the
term ‘‘State distribution factor’’ means an
amount equal to the number of living cases
of HIV/AIDS in the State involved, as determined under subparagraph (D).
(C) Non-EMA distribution factor
For purposes of subparagraph (A)(ii)(II),
the term ‘‘non-ema 1 distribution factor’’
means an amount equal to the sum of—
(i) the number of living cases of HIV/
AIDS in the State involved, as determined
under subparagraph (D); less
(ii) a number equal to the sum of—
(I) the total number of living cases of
HIV/AIDS that are within areas in such
State that are eligible areas under subpart I of part A for the fiscal year involved, which individual number for an
area is the number that applies under
section 300ff–11 of this title for the area
for such fiscal year; and
(II) the total number of such cases that
are within areas in such State that are
transitional areas under section 300ff–19
of this title for such fiscal year, which
individual number for an area is the
number that applies under such section
for the fiscal year.
(D) Living cases of HIV/AIDS
(i) Requirement of names-based reporting
Except as provided in clause (ii), the
number determined under this subparagraph for a State for a fiscal year for purposes of subparagraph (B) is the number of
living names-based cases of HIV/AIDS in
the State that, as of December 31 of the
most recent calendar year for which such
data is available, have been reported to
and confirmed by the Director of the Centers for Disease Control and Prevention.
(ii) Transition period; exemption regarding
non-AIDS cases
For each of the fiscal years 2007 through
2012, a State is, subject to clauses (iii)
through (v), exempt from the requirement
under clause (i) that living non-AIDS
names-based cases of HIV be reported unless—
1 So

in original. Probably should be ‘‘ ‘non-EMA’’.

§ 300ff–28

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(I) a system was in operation as of December 31, 2005, that provides sufficiently accurate and reliable namesbased reporting of such cases throughout
the State, subject to clause (vii); or
(II) no later than the beginning of fiscal year 2008 or a subsequent fiscal year
through fiscal year 2012, the Secretary,
after consultation with the chief executive of the State, determines that a system has become operational in the State
that provides sufficiently accurate and
reliable names-based reporting of such
cases throughout the State.
(iii) Requirements for exemption for fiscal
year 2007
For fiscal year 2007, an exemption under
clause (ii) for a State applies only if, by
October 1, 2006—
(I)(aa) the State had submitted to the
Secretary a plan for making the transition to sufficiently accurate and reliable
names-based reporting of living nonAIDS cases of HIV; or
(bb) all statutory changes necessary to
provide for sufficiently accurate and reliable reporting of such cases had been
made; and
(II) the State had agreed that, by April
1, 2008, the State will begin accurate and
reliable names-based reporting of such
cases, except that such agreement is not
required to provide that, as of such date,
the system for such reporting be fully
sufficient with respect to accuracy and
reliability throughout the area.
(iv) Requirement for exemption as of fiscal
year 2008
For each of the fiscal years 2008 through
2012, an exemption under clause (ii) for a
State applies only if, as of April 1, 2008, the
State is substantially in compliance with
the agreement under clause (iii)(II).
(v) Progress toward names-based reporting
For fiscal year 2009 or a subsequent fiscal
year, the Secretary may terminate an exemption under clause (ii) for a State if the
State submitted a plan under clause
(iii)(I)(aa) and the Secretary determines
that the State is not substantially following the plan.
(vi) Counting of cases in areas with exemptions
(I) In general
With respect to a State that is under a
reporting system for living non-AIDS
cases of HIV that is not names-based (referred to in this subparagraph as ‘‘codebased reporting’’), the Secretary shall,
for purposes of this subparagraph, modify the number of such cases reported for
the State in order to adjust for duplicative reporting in and among systems
that use code-based reporting.
(II) Adjustment rate
The adjustment rate under subclause
(I) for a State shall be a reduction of 5

Page 1242

percent for fiscal years before fiscal year
2012 (and 6 percent for fiscal year 2012) in
the number of living non-AIDS cases of
HIV reported for the State.
(III) Increased adjustment for certain
States previously using code-based
reporting
For purposes of this subparagraph for
each of fiscal years 2010 through 2012, the
Secretary shall deem the applicable
number of living cases of HIV/AIDS in a
State that were reported to and confirmed by the Centers for Disease Control and Prevention to be 3 percent higher than the actual number if—
(aa) there is an area in such State
that satisfies all of the conditions described in items (aa) through (cc) of
section 300ff–13(a)(3)(C)(vi)(III) of this
title; or
(bb)(AA) fiscal year 2007 was the first
year in which the count of living nonAIDS cases of HIV in such area, for
purposes of this part, was based on a
names-based reporting system; and
(BB) the amount of funding that such
State received under this part for fiscal year 2007 was less than 70 percent
of the amount of funding that such
State received under such part for fiscal year 2006.
(vii) List of States meeting standard regarding December 31, 2005
(I) In general
If a State is specified in subclause (II),
the State shall be considered to meet the
standard described in clause (ii)(I). No
other State may be considered to meet
such standard.
(II) Relevant States
For purposes of subclause (I), the
States specified in this subclause are the
following: Alaska, Alabama, Arkansas,
Arizona, Colorado, Florida, Indiana,
Iowa, Idaho, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi,
North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New
York, Nevada, Ohio, Oklahoma, South
Carolina, South Dakota, Tennessee,
Texas, Utah, Virginia, Wisconsin, West
Virginia, Wyoming, Guam, and the Virgin Islands.
(viii) Rules of construction regarding acceptance of reports
(I) Cases of AIDS
With respect to a State that is subject
to the requirement under clause (i) and
is not in compliance with the requirement for names-based reporting of living
non-AIDS cases of HIV, the Secretary
shall, notwithstanding such noncompliance, accept reports of living cases of
AIDS that are in accordance with such
clause.
(II) Applicability of exemption requirements
The provisions of clauses (ii) through
(vii) may not be construed as having any

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

legal effect for fiscal year 2013 or any
subsequent fiscal year, and accordingly,
the status of a State for purposes of such
clauses may not be considered after fiscal year 2012.
(ix) Program for detecting inaccurate or
fraudulent counting
The Secretary shall carry out a program
to monitor the reporting of names-based
cases for purposes of this subparagraph
and to detect instances of inaccurate reporting, including fraudulent reporting.
(x) Future fiscal years
For fiscal years beginning with fiscal
year 2013, determinations under this paragraph shall be based only on living namesbased cases of HIV/AIDS with respect to
the State involved.
(E) Code-based States; limitation on increase
in grant
(i) In general
For each of the fiscal years 2007 through
2012, if code-based reporting (within the
meaning of subparagraph (D)(vi)) applies
in a State as of the beginning of the fiscal
year involved, then notwithstanding any
other provision of this paragraph, the
amount of the grant pursuant to paragraph (1) for the State may not for the fiscal year involved exceed by more than 5
percent the amount of the grant pursuant
to this paragraph for the State for the preceding fiscal year, except that the limitation under this clause may not result in a
grant pursuant to paragraph (1) for a fiscal
year that is less than the minimum
amount that applies to the State under
such paragraph for such fiscal year.
(ii) Use of amounts involved
For each of the fiscal years 2007 through
2012, amounts available as a result of the
limitation under clause (i) shall be made
available by the Secretary as additional
amounts for grants pursuant to section
300ff–29a of this title, subject to subparagraph (H).
(F) Appropriations for treatment drug program
(i) Formula grants
With respect to the fiscal year involved,
if under section 300ff–31b of this title an
appropriations Act provides an amount exclusively for carrying out section 300ff–26
of this title, the portion of such amount
allocated to a State shall be the product
of—
(I) 100 percent of such amount, less the
percentage reserved under clause (ii)(V);
and
(II) the percentage constituted by the
ratio of the State distribution factor for
the State (as determined under subparagraph (B)) to the sum of the State distribution factors for all States;
which product shall then, as applicable, be
increased under subparagraph (H).

§ 300ff–28

(ii) Supplemental treatment drug grants
(I) In general
From amounts made available under
subclause (V), the Secretary shall award
supplemental grants to States described
in subclause (II) to enable such States to
purchase and distribute to eligible individuals under section 300ff–26(b) of this
title pharmaceutical therapeutics described under subsections (c)(2) and (e) of
such section.
(II) Eligible States
For purposes of subclause (I), a State
shall be an eligible State if the State did
not have unobligated funds subject to reallocation under subsection (d) in the
previous fiscal year and, in accordance
with criteria established by the Secretary, demonstrates a severe need for a
grant under this clause. For purposes of
determining severe need, the Secretary
shall consider eligibility standards, formulary composition, the number of eligible individuals to whom a State is unable to provide therapeutics described in
section 300ff–26(a) of this title, and an
unanticipated increase of eligible individuals with HIV/AIDS.
(III) State requirements
The Secretary may not make a grant
to a State under this clause unless the
State agrees that the State will make
available (directly or through donations
of public or private entities) non-Federal
contributions toward the activities to be
carried out under the grant in an
amount equal to $1 for each $4 of Federal
funds provided in the grant, except that
the Secretary may waive this subclause
if the State has otherwise fully complied
with section 300ff–27(d) of this title with
respect to the grant year involved. The
provisions of this subclause shall apply
to States that are not required to comply with such section 300ff–27(d) of this
title.
(IV) Use and coordination
Amounts made available under a grant
under this clause shall only be used by
the State to provide HIV/AIDS-related
medications. The State shall coordinate
the use of such amounts with the
amounts otherwise provided under section 300ff–26(a) of this title in order to
maximize drug coverage.
(V) Funding
For the purpose of making grants
under this clause, the Secretary shall
each fiscal year reserve 5 percent of the
amount referred to in clause (i) with respect to section 300ff–26 of this title.
(iii) Code-based States; limitation on increase in formula grant
The limitation under subparagraph (E)(i)
applies to grants pursuant to clause (i) of
this subparagraph to the same extent and
in the same manner as such limitation ap-

§ 300ff–28

TITLE 42—THE PUBLIC HEALTH AND WELFARE

plies to grants pursuant to paragraph (1),
except that the reference to minimum
grants does not apply for purposes of this
clause. Amounts available as a result of
the limitation under the preceding sentence shall be made available by the Secretary as additional amounts for grants
under clause (ii) of this subparagraph.
(G) Repealed. Pub. L. 109–415, title II,
§ 203(b)(2), Dec. 19, 2006, 120 Stat. 2792
(H) Increase in formula grants
(i) Assurance of amount
(I) General rule
For fiscal year 2010, the Secretary
shall ensure, subject to clauses (ii)
through (iv), that the total for a State of
the grant pursuant to paragraph (1) and
the grant pursuant to subparagraph (F)
is not less than 95 percent of such total
for the State for fiscal year 2009.
(II) Rule of construction
With respect to the application of subclause (I), the 95 percent requirement
under such subclause shall apply with respect to each grant awarded under paragraph (1) and with respect to each grant
awarded under subparagraph (F).
(ii) Fiscal years 2011 and 2012
For each of the fiscal years 2011 and 2012,
the Secretary shall ensure that the total
for a State of the grant pursuant to paragraph (1) and the grant pursuant to subparagraph (F) is not less than 100 percent
of such total for the State for fiscal year
2010.
(iii) Fiscal year 2013
For fiscal year 2013, the Secretary shall
ensure that the total for a State of the
grant pursuant to paragraph (1) and the
grant pursuant to subparagraph (F) is not
less than 92.5 percent of such total for the
State for fiscal year 2012.
(iv) Source of funds for increase
(I) In general
From the amount reserved under section 300ff–31b(b)(2) of this title for a fiscal year, and from amounts available for
such section pursuant to subsection (d)
of this section, the Secretary shall make
available such amounts as may be necessary to comply with clause (i).
(II) Pro rata reduction
If the amounts referred to in subclause
(I) for a fiscal year are insufficient to
fully comply with clause (i) for the year,
the Secretary, in order to provide the additional funds necessary for such compliance, shall reduce on a pro rata basis the
amount of each grant pursuant to paragraph (1) for the fiscal year, other than
grants for States for which increases
under clause (i) apply and other than
States described in paragraph (1)(A)(i)(I).
A reduction under the preceding sentence may not be made in an amount

Page 1244

that would result in the State involved
becoming eligible for such an increase.
(v) Applicability
This paragraph may not be construed as
having any applicability after fiscal year
2013.
(b) Allocation of assistance by States
(1) Allowances
Prior to allocating assistance under this
subsection, a State shall consider the unmet
needs of those areas that have not received financial assistance under part A of this subchapter.
(2) Planning and evaluations
Subject to paragraph (4) and except as provided in paragraph (5), a State may not use
more than 10 percent of amounts received
under a grant awarded under section 300ff–21 of
this title for planning and evaluation activities.
(3) Administration
(A) In general
Subject to paragraph (4), and except as
provided in paragraph (5), a State may not
use more than 10 percent of amounts received under a grant awarded under section
300ff–21 of this title for administration.
(B) Allocations
In the case of entities and subcontractors
to which a State allocates amounts received
by the State under a grant under section
300ff–21 of this title, the State shall ensure
that, of the aggregate amount so allocated,
the total of the expenditures by such entities for administrative expenses does not exceed 10 percent (without regard to whether
particular entities expend more than 10 percent for such expenses).
(C) Administrative activities
For the purposes of subparagraph (A),
amounts may be used for administrative activities that include routine grant administration and monitoring activities, including
a clinical quality management program
under subparagraph (E).
(D) Subcontractor administrative costs
For the purposes of this paragraph, subcontractor administrative activities include—
(i) usual and recognized overhead, including established indirect rates for agencies;
(ii) management oversight of specific
programs funded under this subchapter;
and
(iii) other types of program support such
as quality assurance, quality control, and
related activities.
(E) Clinical quality management
(i) Requirement
Each State that receives a grant under
section 300ff–21 of this title shall provide
for the establishment of a clinical quality
management program to assess the extent
to which HIV health services provided to

Page 1245

TITLE 42—THE PUBLIC HEALTH AND WELFARE

patients under the grant are consistent
with the most recent Public Health Service guidelines for the treatment of HIV/
AIDS and related opportunistic infection,
and as applicable, to develop strategies for
ensuring that such services are consistent
with the guidelines for improvement in the
access to and quality of HIV health services.
(ii) Use of funds
(I) In general
From amounts received under a grant
awarded under section 300ff–21 of this
title for a fiscal year, a State may use
for activities associated with the clinical
quality management program required
in clause (i) not to exceed the lesser of—
(aa) 5 percent of amounts received
under the grant; or
(bb) $3,000,000.
(II) Relation to limitation on administrative expenses
The costs of a clinical quality management program under clause (i) may not
be considered administrative expenses
for purposes of the limitation established in subparagraph (A).
(4) Limitation on use of funds
Except as provided in paragraph (5), a State
may not use more than a total of 15 percent of
amounts received under a grant awarded under
section 300ff–21 of this title for the purposes
described in paragraphs (2) and (3).
(5) Exception
With respect to a State that receives the
minimum allotment under subsection (a)(1) of
this section for a fiscal year, such State, from
the amounts received under a grant awarded
under section 300ff–21 of this title for such fiscal year for the activities described in paragraphs (2) and (3), may, notwithstanding paragraphs (2) through (4), use not more than that
amount required to support one full-timeequivalent employee.
(6) Construction
A State may not use amounts received under
a grant awarded under section 300ff–21 of this
title to purchase or improve land, or to purchase, construct, or permanently improve
(other than minor remodeling) any building or
other facility, or to make cash payments to
intended recipients of services.
(c) Expedited distribution
(1) In general
Not less than 75 percent of the amounts received under a grant awarded to a State under
section 300ff–21 of this title shall be obligated
to specific programs and projects and made
available for expenditure not later than—
(A) in the case of the first fiscal year for
which amounts are received, 150 days after
the receipt of such amounts by the State;
and
(B) in the case of succeeding fiscal years,
120 days after the receipt of such amounts by
the State.

§ 300ff–28

(2) Public comment
Within the time periods referred to in paragraph (1), the State shall invite and receive
public comment concerning methods for the
utilization of such amounts.
(d) Reallocation
Any portion of a grant made to a State under
section 300ff–21 of this title for a fiscal year that
has not been obligated as described in subsection (c) ceases to be available to the State
and shall be made available by the Secretary for
grants under section 300ff–29a of this title, in addition to amounts made available for such
grants under section 300ff–31b(b)(2) of this title.
(July 1, 1944, ch. 373, title XXVI, § 2618, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 595; amended Pub. L. 102–531, title III,
§ 312(d)(30), Oct. 27, 1992, 106 Stat. 3506; Pub. L.
104–146, §§ 3(c)(5), (g)(2), 5, 6(c)(3), May 20, 1996, 110
Stat. 1355, 1363, 1365, 1368; Pub. L. 105–392, title
IV, § 417, Nov. 13, 1998, 112 Stat. 3591; Pub. L.
106–345, title II, § 206, Oct. 20, 2000, 114 Stat. 1334;
Pub. L. 109–415, title II, §§ 203, 204(a), title VII,
§§ 702(1), 703, Dec. 19, 2006, 120 Stat. 2789, 2796,
2819, 2820; Pub. L. 111–87, §§ 2(a)(1), (3)(A), 3(b),
5(b), (c)(1), 7(b), 10(b), Oct. 30, 2009, 123 Stat. 2885,
2888, 2890, 2891, 2893, 2895.)
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a)(2)(A)(i). Pub. L. 111–87, § 5(c)(1), substituted ‘‘subparagraph (F)’’ for ‘‘subparagraph (G)’’.
Subsec. (a)(2)(D)(ii). Pub. L. 111–87, § 3(b)(1)(A)(i), substituted ‘‘2012’’ for ‘‘2009’’ in introductory provisions.
Subsec. (a)(2)(D)(ii)(II). Pub. L. 111–87, § 3(b)(1)(A)(ii),
substituted ‘‘or a subsequent fiscal year through fiscal
year 2012’’ for ‘‘or 2009’’.
Subsec. (a)(2)(D)(iv). Pub. L. 111–87, § 3(b)(1)(B), substituted ‘‘2012’’ for ‘‘2010’’.
Subsec. (a)(2)(D)(v). Pub. L. 111–87, § 3(b)(1)(C), inserted ‘‘or a subsequent fiscal year’’ after ‘‘2009’’.
Subsec. (a)(2)(D)(vi)(II). Pub. L. 111–87, § 3(b)(1)(D), inserted ‘‘for fiscal years before fiscal year 2012 (and 6
percent for fiscal year 2012)’’ after ‘‘5 percent’’.
Subsec. (a)(2)(D)(vi)(III). Pub. L. 111–87, § 7(b), added
subcl. (III).
Subsec. (a)(2)(D)(viii)(II). Pub. L. 111–87, § 3(b)(1)(E),
substituted ‘‘2013’’ for ‘‘2010’’ and ‘‘2012’’ for ‘‘2009’’.
Subsec. (a)(2)(D)(x). Pub. L. 111–87, § 3(b)(1)(F), added
cl. (x).
Subsec. (a)(2)(E)(i), (ii). Pub. L. 111–87, § 3(b)(2), substituted ‘‘2012’’ for ‘‘2009’’.
Subsec. (a)(2)(F)(ii)(V). Pub. L. 111–87, § 10(b), struck
out ‘‘, subject to subclause (VI)’’ before period.
Subsec. (a)(2)(H)(i). Pub. L. 111–87, § 5(b)(1), (c)(1), substituted ‘‘2010’’ for ‘‘2007’’ and ‘‘2009’’ for ‘‘2006’’ and substituted ‘‘subparagraph (F)’’ for ‘‘subparagraph (G)’’ in
two places.
Subsec. (a)(2)(H)(ii). Pub. L. 111–87, § 5(b)(3), (c)(1), in
heading, substituted ‘‘2011 and 2012’’ for ‘‘2008 and 2009’’
and, in text, substituted ‘‘2011 and 2012’’ for ‘‘2008 and
2009’’, ‘‘subparagraph (F)’’ for ‘‘subparagraph (G)’’, and
‘‘2010’’ for ‘‘2007’’.
Pub. L. 111–87, § 5(b)(2), redesignated cl. (iii) as (ii) and
struck out former cl. (ii). Prior to amendment, text
read as follows: ‘‘For purposes of clause (i) as applied
for fiscal year 2007, the references in such clause to subparagraph (G) are deemed to be references to subparagraph (I) as such subparagraph was in effect for fiscal
year 2006.’’
Subsec. (a)(2)(H)(iii). Pub. L. 111–87, § 5(b)(4), added cl.
(iii). Former cl. (iii) redesignated (ii).

§ 300ff–28

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (a)(2)(H)(v). Pub. L. 111–87, § 5(b)(5), substituted ‘‘2013’’ for ‘‘2009’’.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a)(1). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’ in introductory provisions.
Pub. L. 109–415, § 203(g)(1), substituted ‘‘section
300ff–31b of this title’’ for ‘‘section 300ff–77 of this title’’
in introductory provisions.
Subsec. (a)(1)(A). Pub. L. 109–415, § 203(g)(2)(A), substituted ‘‘each of the 50 States, the District of Columbia, Guam, and the Virgin Islands (referred to in this
paragraph as a ‘covered State’)’’ for ‘‘each of the several States and the District of Columbia’’ in introductory provisions.
Subsec. (a)(1)(A)(i)(I). Pub. L. 109–415, § 702(1), substituted ‘‘AIDS’’ for ‘‘acquired immune deficiency syndrome’’.
Pub. L. 109–415, § 203(g)(2)(B)(i), substituted ‘‘covered
State’’ for ‘‘State or District’’.
Subsec. (a)(1)(A)(i)(II). Pub. L. 109–415, § 702(1), substituted ‘‘AIDS’’ for ‘‘acquired immune deficiency syndrome’’.
Pub. L. 109–415, § 203(g)(2)(B)(ii), substituted ‘‘covered
State’’ for ‘‘State or District’’ and inserted ‘‘and’’ at
end.
Subsec. (a)(1)(B). Pub. L. 109–415, § 203(g)(3), substituted ‘‘each territory other than Guam and the Virgin Islands’’ for ‘‘each territory of the United States, as
defined in paragraph (3),’’.
Subsec. (a)(2)(A). Pub. L. 109–415, § 203(b)(1)(A), in introductory provisions substituted ‘‘For purposes of
paragraph (1), the amount referred to in this paragraph
for a State (including a territory) for a fiscal year is,
subject to subparagraphs (E) and (F)’’ for ‘‘The amount
referred to in paragraph (1)(A)(ii) for a State and paragraph (1)(B) for a territory of the United States shall be
the product of’’, added cl. (i), and struck out former cl.
(i) which read as follows:
‘‘(i) an amount equal to the amount appropriated
under section 300ff–77 of this title for the fiscal year involved for grants under this part, subject to subparagraphs (H) and (I); and’’.
Subsec. (a)(2)(A)(ii)(I). Pub. L. 109–415, § 203(b)(1)(B)(i),
substituted ‘‘0.75’’ for ‘‘.80’’ and struck out ‘‘and’’ at
end.
Subsec.
(a)(2)(A)(ii)(II).
Pub.
L.
109–415,
§ 203(b)(1)(B)(ii), inserted ‘‘non-EMA’’ after ‘‘respective’’
and substituted ‘‘; and’’ for period at end.
Subsec.
(a)(2)(A)(ii)(III).
Pub.
L.
109–415,
§ 203(b)(1)(B)(iii), added subcl. (III).
Subsec. (a)(2)(B). Pub. L. 109–415, § 203(a)(1)(A), substituted ‘‘number of living cases of HIV/AIDS in the
State involved’’ for ‘‘estimated number of living cases
of acquired immune deficiency syndrome in the eligible
area involved’’.
Subsec. (a)(2)(C)(i). Pub. L. 109–415, § 203(g)(4), struck
out ‘‘or territory’’ after ‘‘State’’.
Pub. L. 109–415, § 203(a)(2)(A), substituted ‘‘number of
living cases of HIV/AIDS’’ for ‘‘estimated number of
living cases of acquired immune deficiency syndrome’’.
Subsec. (a)(2)(C)(ii). Pub. L. 109–415, § 203(a)(2)(B),
amended cl. (ii) generally. Prior to amendment, cl. (ii)
read as follows: ‘‘the estimated number of living cases
of acquired immune deficiency syndrome in such State
or territory that are within an eligible area (as determined under part A of this subchapter).’’
Subsec. (a)(2)(D). Pub. L. 109–415, § 203(a)(1)(B), amended subpar. (D) generally. Prior to amendment, subpar.
(D) related to estimating the number of living cases of
acquired immune deficiency syndrome in a State or
territory.
Subsec. (a)(2)(E). Pub. L. 109–415, § 203(b)(3), added subpar (E).
Pub. L. 109–415, § 203(b)(2), struck out heading and text
of subpar. (E). Text read as follows: ‘‘If under section
300ff–13(a)(3)(D)(i) of this title the Secretary determines
that data on cases of HIV disease are not sufficiently

Page 1246

accurate and reliable, then notwithstanding subparagraph (D) of this paragraph, for any fiscal year prior to
fiscal year 2007 the references in such subparagraph to
cases of HIV disease do not have any legal effect.’’
Subsec. (a)(2)(F). Pub. L. 109–415, § 203(b)(4), redesignated subpar. (I) as (F).
Pub. L. 109–415, § 203(b)(2), struck out heading and text
of subpar. (F). Text read as follows: ‘‘For purposes of
subparagraph (D), the cost index for Puerto Rico, the
Virgin Islands, and Guam shall be 1.0.’’
Subsec. (a)(2)(F)(i). Pub. L. 109–415, § 203(c)(1), which
directed amendment of subsec. (a)(2)(G)(i) by substituting ‘‘section 300ff–31b of this title’’ for ‘‘section 300ff–77
of this title’’ in introductory provisions, substituting a
semicolon for a period at end of subcl. (II), and adding
concluding provisions, was executed by making the
amendment to subsec. (a)(2)(F)(i), to reflect the probable intent of Congress.
Subsec. (a)(2)(F)(ii). Pub. L. 109–415, § 203(c)(2), which
directed amendment of subsec. (a)(2)(G)(ii) by adding
subcls. (I) to (III), striking out former subcls. (I) to
(III), substituting ‘‘5 percent’’ for ‘‘3 percent’’ in subcl.
(V), striking out subcl. (VI), and realigning margins,
was executed by making the amendments to subsec.
(a)(2)(F)(ii), to reflect the probable intent of Congress.
Prior to amendment, subcls. (I) to (III) and (VI) related
to supplemental grants to States to increase access to
therapeutics described in section 300ff–26(a), eligibility
for grants, requirements for grants, and reservation of
amounts, respectively.
Subsec. (a)(2)(F)(iii). Pub. L. 109–415, § 203(c)(3), which
directed amendment of subsec. (a)(2)(G) by adding cl.
(iii), was executed by making the amendment to subsec. (a)(2)(F), to reflect the probable intent of Congress.
Subsec. (a)(2)(G). Pub. L. 109–415, § 203(b)(2), struck
out heading and text of subpar. (G). Text read as follows: ‘‘The Secretary may, in determining the amount
of a grant for a fiscal year under this subsection, adjust
the grant amount to reflect the amount of unexpended
and uncanceled grant funds remaining at the end of the
fiscal year preceding the year for which the grant determination is to be made. The amount of any such unexpended funds shall be determined using the financial
status report of the grantee.’’
Subsec. (a)(2)(H). Pub. L. 109–415, § 203(d), added subpar. (H).
Pub. L. 109–415, § 203(b)(2), struck out subpar. (H)
which related to amount of grants in fiscal years 2001
to 2005.
Subsec. (a)(2)(I). Pub. L. 109–415, § 203(b)(4), redesignated subpar. (I) as (F).
Subsec. (a)(3). Pub. L. 109–415, § 203(g)(5), struck out
par. (3), which defined ‘‘State’’ and ‘‘territory of the
United States’’ as used in subsec. (a).
Subsec. (b)(1). Pub. L. 109–415, § 203(e)(1), redesignated
par. (2) as (1).
Subsec. (b)(2). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Pub. L. 109–415, § 203(e)(2), substituted ‘‘paragraph (4)’’
for ‘‘paragraph (5)’’ and ‘‘paragraph (5)’’ for ‘‘paragraph
(6)’’.
Pub. L. 109–415, § 203(e)(1), redesignated par. (3) as (2).
Former par. (2) redesignated (1).
Subsec. (b)(3). Pub. L. 109–415, § 203(e)(3), added subpars. (B) and (E), redesignated former subpars. (B) and
(C) as (C) and (D), respectively, inserted ‘‘, including a
clinical quality management program under subparagraph (E)’’ before period at end of subpar. (C), and, in
subpar. (A), reenacted heading without change and
amended text generally. Prior to amendment, subpar.
(A) text read as follows: ‘‘Subject to paragraph (5) and
except as provided in paragraph (6), a State may not
use more than 10 percent of amounts received under a
grant awarded under this part for administration. In
the case of entities and subcontractors to which the
State allocates amounts received by the State under
the grant (including consortia under section 300ff–23 of
this title), the State shall ensure that, of the aggregate
amount so allocated, the total of the expenditures by
such entities for administrative expenses does not ex-

Page 1247

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ceed 10 percent (without regard to whether particular
entities expend more than 10 percent for such expenses).’’
Pub. L. 109–415, § 203(e)(1), redesignated par. (4) as (3).
Former par. (3) redesignated (2).
Subsec. (b)(4). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Pub. L. 109–415, § 203(e)(4), substituted ‘‘paragraph (5)’’
for ‘‘paragraph (6)’’ and ‘‘paragraphs (2) and (3)’’ for
‘‘paragraphs (3) and (4)’’.
Pub. L. 109–415, § 203(e)(1), redesignated par. (5) as (4).
Former par. (4) redesignated (3).
Subsec. (b)(5). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Pub. L. 109–415, § 203(e)(5), substituted ‘‘paragraphs (2)
and (3), may, notwithstanding paragraphs (2) through
(4),’’ for ‘‘paragraphs (3) and (4), may, notwithstanding
paragraphs (3), (4), and (5),’’.
Pub. L. 109–415, § 203(e)(1), redesignated par. (6) as (5).
Former par. (5) redesignated (4).
Subsec. (b)(6). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Pub. L. 109–415, § 203(e)(1), redesignated par. (7) as (6).
Former par. (6) redesignated (5).
Subsec. (b)(7). Pub. L. 109–415, § 203(e)(1), redesignated
par. (7) as (6).
Subsec. (c)(1). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’ in introductory provisions.
Subsec. (d). Pub. L. 109–415, § 203(f), reenacted heading
without change and amended text generally. Prior to
amendment, text read as follows: ‘‘Any amounts appropriated in any fiscal year and made available to a State
under this part that have not been obligated as described in subsection (d) of this section shall be repaid
to the Secretary and reallotted to other States in proportion to the original grants made to such States.’’
2000—Subsec. (a). Pub. L. 106–345, § 206(a)(1), redesignated subsec. (b) as (a).
Subsec. (a)(1)(A)(i). Pub. L. 106–345, § 206(a)(2), substituted ‘‘$200,000’’ for ‘‘$100,000’’ in subcl. (I) and
‘‘$500,000’’ for ‘‘$250,000’’ in subcl. (II).
Subsec. (a)(1)(A)(ii). Pub. L. 106–345, § 206(c)(1), inserted ‘‘and then, as applicable, increased under paragraph (2)(H)’’ before semicolon.
Subsec. (a)(1)(B). Pub. L. 106–345, § 206(d), inserted
‘‘the greater of $50,000 or’’ after ‘‘shall be’’.
Subsec. (a)(2)(A)(i). Pub. L. 106–345, § 206(c)(2)(A), substituted ‘‘subparagraphs (H) and (I)’’ for ‘‘subparagraph
(H)’’.
Subsec. (a)(2)(D)(i). Pub. L. 106–345, § 206(b)(1), inserted
before semicolon ‘‘, except that (subject to subparagraph (E)), for grants made pursuant to this paragraph
or section 300ff–30 of this title for fiscal year 2005 and
subsequent fiscal years, the cases counted for each 12month period beginning on or after July 1, 2004, shall be
cases of HIV disease (as reported to and confirmed by
such Director) rather than cases of acquired immune
deficiency syndrome’’.
Subsec. (a)(2)(E) to (G). Pub. L. 106–345, § 206(b)(2), (3),
added subpar. (E) and redesignated former subpars. (E)
and (F) as (F) and (G), respectively. Former subpar. (G)
redesignated (H).
Subsec. (a)(2)(H). Pub. L. 106–345, § 206(c)(2)(B), amended heading and text of subpar. (H) generally. Prior to
amendment, text related to limitations on the amount
of a grant awarded for fiscal years 1996 to 2000 to a
State or territory under this part in relation to the
amount received by the State or territory for fiscal
year 1995.
Pub. L. 106–345, § 206(b)(2), redesignated subpar. (G) as
(H). Former subpar. (H) redesignated (I).
Subsec. (a)(2)(I). Pub. L. 106–345, § 206(e), reenacted
heading without change, designated existing provisions
as cl. (i), inserted cl. (i) heading, redesignated former
cls. (i) and (ii) as subcls. (I) and (II), respectively, in
subcl. (I) inserted ‘‘, less the percentage reserved under
clause (ii)(V)’’ before semicolon, and added cl. (ii).
Pub. L. 106–345, § 206(b)(2), redesignated subpar. (H) as
(I).

§ 300ff–28

Subsec. (a)(3)(B). Pub. L. 106–345, § 206(f), substituted
‘‘the Republic of the Marshall Islands, the Federated
States of Micronesia, and the Republic of Palau, and
only for purposes of paragraph (1) the Commonwealth
of Puerto Rico’’ for ‘‘and the Republic of the Marshall
Islands’’.
Subsecs. (b) to (e). Pub. L. 106–345, § 206(a)(1), redesignated subsecs. (c) to (e) as (b) to (d), respectively.
1998—Subsec. (b)(3)(A). Pub. L. 105–392, § 417(1), substituted ‘‘, the Commonwealth of Puerto Rico, the Virgin Islands, and Guam’’ for ‘‘and the Commonwealth of
Puerto Rico’’.
Subsec. (b)(3)(B). Pub. L. 105–392, § 417(2), struck out
‘‘the Virgin Islands, Guam’’ after ‘‘means’’.
1996—Subsec. (a). Pub. L. 104–146, § 3(g)(2), struck out
subsec. (a) which related to special projects of national
significance.
Subsec. (a)(1). Pub. L. 104–146, § 6(c)(3)(A), which directed amendment of subsec. (a)(1) by substituting
‘‘section 300ff–77’’ for ‘‘section 300ff–30’’, could not be
executed because of the repeal of subsec. (a) by Pub. L.
104–146, § 3(g)(2). See above.
Subsec. (b)(1). Pub. L. 104–146, § 6(c)(3)(B), which directed amendment of subsec. (b)(1) by substituting
‘‘section 300ff–77 of this title’’ for ‘‘section 300ff–30 of
this title’’, could not be executed because the words
‘‘section 300ff–30 of this title’’ did not appear subsequent to the general amendment of subsec. (b)(1) by
Pub. L. 104–146, § 5. See below.
Pub. L. 104–146, § 5, amended heading and text of par.
(1) generally. Prior to amendment, text read as follows:
‘‘Subject to the extent of amounts made available
under section 300ff–30 of this title, the amount of a
grant to be made under this part for—
‘‘(A) each of the several States and the District of
Columbia for a fiscal year shall be the greater of—
‘‘(i) $100,000, and
‘‘(ii) an amount determined under paragraph (2);
and
‘‘(B) each territory of the United States, as defined
in paragraph 3, shall be an amount determined under
paragraph (2).’’
Subsec. (b)(2). Pub. L. 104–146, § 5, amended par. (2)
generally, substituting subpars. (A) to (H) for former
subpars. (A) and (B) relating to determination of
amount of allotments.
Subsec. (c)(1). Pub. L. 104–146, § 3(c)(5)(A), struck out
heading and text of par. (1). Text read as follows: ‘‘In
a State that has reported 1 percent or more of all AIDS
cases reported to and confirmed by the Centers for Disease Control and Prevention in all States, not less than
50 percent of the amount received by the State under a
grant awarded under this part shall be utilized for the
creation and operation of community-based comprehensive care consortia under section 300ff–23 of this
title, in those areas within the State in which the largest number of individuals with HIV disease reside.’’
Subsec. (c)(3), (4). Pub. L. 104–146, § 3(c)(5)(B), amended
pars. (3) and (4) generally. Prior to amendment, pars.
(3) and (4) read as follows:
‘‘(3) PLANNING AND EVALUATIONS.—A State may not
use in excess of 5 percent of amounts received under a
grant awarded under this part for planning and evaluation activities.
‘‘(4) ADMINISTRATION.—A State may not use in excess
of 5 percent of amounts received under a grant awarded
under this part for administration, accounting, reporting, and program oversight functions.’’
Subsec. (c)(5) to (7). Pub. L. 104–146, § 3(c)(5)(C), (D),
added pars. (5) and (6) and redesignated former par. (5)
as (7).
1992—Subsec. (c)(1). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers
for Disease Control’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in

§ 300ff–29

TITLE 42—THE PUBLIC HEALTH AND WELFARE

effect on Sept. 30, 2009, be revived, and that amendment
by sections 3(b), 5(b), (c)(1), 7(b), and 10(b) of Pub. L.
111–87 be applicable to this section as so revived and effective as if enacted on Sept. 30, 2009, see section 2(a)(2),
(3) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by sections 3(c)(5), (g)(2) and 6(c)(3)(A) of
Pub. L. 104–146 effective Oct. 1, 1996, and amendment by
sections 5 and 6(c)(3)(B) of Pub. L. 104–146 effective May
20, 1996, see section 13 of Pub. L. 104–146, set out as a
note under section 300ff–11 of this title.

§ 300ff–29. Technical assistance
The Secretary shall provide technical assistance in administering and coordinating the activities authorized under section 300ff–22 of this
title, including technical assistance for the development and implementation of statewide
coordinated statements of need.
(July 1, 1944, ch. 373, title XXVI, § 2619, as added
Pub. L. 101–381, title II, § 201, Aug. 18, 1990, 104
Stat. 597; amended Pub. L. 104–146, § 3(c)(6), May
20, 1996, 110 Stat. 1356; Pub. L. 109–415, title VII,
§ 703, Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
1996—Pub. L. 104–146 substituted ‘‘shall’’ for ‘‘may’’
and inserted ‘‘, including technical assistance for the
development and implementation of statewide coordinated statements of need’’ before period at end.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
and amendment by section 6(c)(1)(A) of Pub. L. 104–146
effective May 20, 1996, see section 13 of Pub. L. 104–146,
set out as a note under section 300ff–11 of this title.

§ 300ff–29a. Supplemental grants
(a) In general
For the purpose of providing services described
in section 300ff–22(a) of this title, the Secretary
shall make grants to States—
(1) whose applications under section 300ff–27
of this title have demonstrated the need in the
State, on an objective and quantified basis, for
supplemental financial assistance to provide
such services; and
(2) that did not, for the most recent grant
year pursuant to section 300ff–28(a)(1) or
300ff–28(a)(2)(F)(i) of this title for which data is
available, have more than 5 percent of grant
funds under such sections canceled, offset
under section 300ff–31a(e) of this title, or cov-

Page 1248

ered by any waivers under section 300ff–31a(c)
of this title.
(b) Demonstrated need
The factors considered by the Secretary in determining whether an eligible area has a demonstrated need for purposes of subsection (a)(1)
may include any or all of the following:
(1) The unmet need for such services, as determined under section 300ff–27(b) of this title.
(2) An increasing need for HIV/AIDS-related
services, including relative rates of increase in
the number of cases of HIV/AIDS.
(3) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging subpopulations.
(4) The current prevalence of HIV/AIDS.
(5) Relevant factors related to the cost and
complexity of delivering health care to individuals with HIV/AIDS in the eligible area.
(6) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.
(7) The prevalence of homelessness.
(8) The prevalence of individuals described
under section 300ff–12(b)(2)(M) of this title.
(9) The relevant factors that limit access to
health care, including geographic variation,
adequacy of health insurance coverage, and
language barriers.
(10) The impact of a decline in the amount
received pursuant to section 300ff–28 of this
title on services available to all individuals
with HIV/AIDS identified and eligible under
this subchapter.
(c) Priority in making grants
The Secretary shall provide funds under this
section to a State to address the decline in services related to the decline in the amounts received pursuant to section 300ff–28 of this title
consistent with the grant award to the State for
fiscal year 2006, to the extent that the factor
under subsection (b)(10) (relating to a decline in
funding) applies to the State.
(d) Report on the awarding of supplemental
funds
Not later than 45 days after the awarding of
supplemental funds under this section, the Secretary shall submit to Congress a report concerning such funds. Such report shall include information detailing—
(1) the total amount of supplemental funds
available under this section for the year involved;
(2) the amount of supplemental funds used in
accordance with the hold harmless provisions
of section 300ff–28(a)(2) of this title;
(3) the amount of supplemental funds disbursed pursuant to subsection (c);
(4) the disbursement of the remainder of the
supplemental funds after taking into account
the uses described in paragraphs (2) and (3);
and
(5) the rationale used for the amount of
funds disbursed as described under paragraphs
(2), (3), and (4).
(e) Core medical services
The provisions of section 300ff–22(b) of this
title apply with respect to a grant under this

Page 1249

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section to the same extent and in the same manner as such provisions apply with respect to a
grant made pursuant to section 300ff–28(a)(1) of
this title.
(f) Applicability of grant authority
The authority to make grants under this section applies beginning with the first fiscal year
for which amounts are made available for such
grants under section 300ff–31b(b)(1) of this title.
(July 1, 1944, ch. 373, title XXVI, § 2620, as added
and amended Pub. L. 109–415, title II, § 205(2),
title VII, § 703, Dec. 19, 2006, 120 Stat. 2797, 2820;
Pub. L. 111–87, §§ 2(a)(1), (3)(A), 5(c)(2), 8(a)(2),
(b)(2)(D), Oct. 30, 2009, 123 Stat. 2885, 2891, 2893,
2894.)
PRIOR PROVISIONS
A prior section 2620 of act July 1, 1944, was renumbered section 2621 and is classified to section 300ff–30 of
this title.
Another prior section 2620 of act July 1, 1944, was
classified to section 300ff–30 of this title prior to repeal
by Pub. L. 104–146.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a)(2). Pub. L. 111–87, §§ 5(c)(2), 8(a)(2),
(b)(2)(D),
substituted
‘‘300ff–28(a)(2)(F)(i)’’
for
‘‘300ff–28(a)(2)(G)(i)’’, ‘‘5 percent’’ for ‘‘2 percent’’, and
‘‘canceled, offset under section 300ff–31a(e) of this
title,’’ for ‘‘canceled’’.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 5(c)(2) and 8(a)(2), (b)(2)(D) of Pub. L. 111–87
be applicable to this section as so revived and effective
as if enacted on Sept. 30, 2009, see section 2(a)(2), (3) of
Pub. L. 111–87, set out as a note under section 300ff–11
of this title.

§ 300ff–30. Emerging communities
(a) In general
The Secretary shall award supplemental
grants to States determined to be eligible under
subsection (b) of this section to enable such
States to provide comprehensive services of the
type described in section 300ff–22(a) of this title
to supplement the services otherwise provided
by the State under a grant under this subpart in
emerging communities within the State that are
not eligible to receive grants under part A of
this subchapter.
(b) Eligibility
To be eligible to receive a supplemental grant
under subsection (a) of this section, a State
shall—
(1) be eligible to receive a grant under this
subpart;
(2) demonstrate the existence in the State of
an emerging community as defined in subsection (d)(1) of this section;

§ 300ff–30

(3) agree that the grant will be used to provide funds directly to emerging communities
in the State, separately from other funds
under this subchapter that are provided by the
State to such communities; and
(4) submit the information described in subsection (c) of this section.
(c) Reporting requirements
A State that desires a grant under this section
shall, as part of the State application submitted
under section 300ff–27 of this title, submit a detailed description of the manner in which the
State will use amounts received under the grant
and of the severity of need. Such description
shall include—
(1) a report concerning the dissemination of
supplemental funds under this section and the
plan for the utilization of such funds in the
emerging community;
(2) a demonstration of the existing commitment of local resources, both financial and inkind;
(3) a demonstration that the State will
maintain HIV-related activities at a level that
is equal to not less than the level of such activities in the State for the 1-year period preceding the fiscal year for which the State is
applying to receive a grant under section
300ff–21 of this title;
(4) a demonstration of the ability of the
State to utilize such supplemental financial
resources in a manner that is immediately responsive and cost effective;
(5) a demonstration that the resources will
be allocated in accordance with the local demographic incidence of AIDS including appropriate allocations for services for infants, children, women, and families with HIV/AIDS;
(6) a demonstration of the inclusiveness of
the planning process, with particular emphasis
on affected communities and individuals with
HIV/AIDS; and
(7) a demonstration of the manner in which
the proposed services are consistent with local
needs assessments and the statewide coordinated statement of need.
(d) Definitions of emerging community
For purposes of this section, the term ‘‘emerging community’’ means a metropolitan area (as
defined in section 300ff–17 of this title) for which
there has been reported to and confirmed by the
Director of the Centers for Disease Control and
Prevention a cumulative total of at least 500,
but fewer than 1,000, cases of AIDS during the
most recent period of 5 calendar years for which
such data are available.
(e) Continued status as emerging community
Notwithstanding any other provision of this
section, a metropolitan area that is an emerging
community for a fiscal year continues to be an
emerging community until the metropolitan
area fails, for three consecutive fiscal years—
(1) to meet the requirements of subsection
(d); and
(2) to have a cumulative total of 750 or more
living cases of AIDS (reported to and confirmed by the Director of the Centers for Disease Control and Prevention) as of December
31 of the most recent calendar year for which
such data is available.

§ 300ff–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Distribution
The amount of a grant under subsection (a) for
a State for a fiscal year shall be an amount
equal to the product of—
(1) the amount available under section
300ff–31b(b)(1) of this title for the fiscal year;
and
(2) a percentage equal to the ratio constituted by the number of living cases of HIV/
AIDS in emerging communities in the State to
the sum of the respective numbers of such
cases in such communities for all States.
(July 1, 1944, ch. 373, title XXVI, § 2621, formerly
§ 2620, as added Pub. L. 106–345, title II, § 207(2),
Oct. 20, 2000, 114 Stat. 1337; renumbered § 2621 and
amended Pub. L. 109–415, title II, §§ 204(a), 205(1),
206, title VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat.
2796, 2797, 2799, 2820; Pub. L. 111–87, § 2(a)(1),
(3)(A), Oct. 30, 2009, 123 Stat. 2885.)
PRIOR PROVISIONS
A prior section 300ff–30, act July 1, 1944, ch. 373, title
XXVI, § 2620, as added Aug. 18, 1990, Pub. L. 101–381, title
II, § 201, 104 Stat. 597, authorized appropriations for fiscal years 1991 through 1995, prior to repeal by Pub. L.
104–146, §§ 6(b), 13, May 20, 1996, 110 Stat. 1367, 1374, effective Oct. 1, 1996.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 206(1), substituted ‘‘Emerging communities’’ for ‘‘Supplemental grants’’ in section catchline.
Subsec. (b)(3), (4). Pub. L. 109–415, § 206(2), added par.
(3) and redesignated former par. (3) as (4).
Subsec. (c)(3). Pub. L. 109–415, § 204(a), substituted
‘‘section 300ff–21 of this title’’ for ‘‘this part’’.
Subsec. (c)(5), (6). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Subsecs. (d) to (f). Pub. L. 109–415, § 206(3), added subsecs. (d) to (f) and struck out former subsecs. (d) and (e)
defining ‘‘emerging community’’ and relating to funding, respectively.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–31. Repealed. Pub. L. 106–345, title II,
§ 207(1), Oct. 20, 2000, 114 Stat. 1337
Section, act July 1, 1944, ch. 373, title XXVI, § 2621, as
added Pub. L. 104–146, § 3(c)(7), May 20, 1996, 110 Stat.
1356, related to coordination of planning and implementation of Federal HIV programs to facilitate the local
development of a complete continuum of HIV-related
services for individuals with HIV disease and those at
risk of such disease and required a biennial report to
Congress on coordination efforts.

§ 300ff–31a. Timeframe for obligation and expenditure of grant funds
(a) Obligation by end of grant year
Effective for fiscal year 2007 and subsequent
fiscal years, funds from a grant award made to

Page 1250

a State for a fiscal year pursuant to section
300ff–28(a)(1) or 300ff–28(a)(2)(F) of this title, or
under section 300ff–29a or 300ff–30 of this title,
are available for obligation by the State
through the end of the one-year period beginning on the date in such fiscal year on which
funds from the award first become available to
the State (referred to in this section as the
‘‘grant year for the award’’), except as provided
in subsection (c)(1).
(b) Supplemental grants; cancellation of unobligated balance of grant award
Effective for fiscal year 2007 and subsequent
fiscal years, if a grant award made to a State for
a
fiscal
year
pursuant
to
section
300ff–28(a)(2)(F)(ii) of this title, or under section
300ff–29a or 300ff–30 of this title, has an unobligated balance as of the end of the grant year for
the award—
(1) the Secretary shall cancel that unobligated balance of the award, and shall require
the State to return any amounts from such
balance that have been disbursed to the State;
and
(2) the funds involved shall be made available by the Secretary as additional amounts
for grants pursuant to section 300ff–29a of this
title for the first fiscal year beginning after
the fiscal year in which the Secretary obtains
the information necessary for determining
that the balance is required under paragraph
(1) to be canceled, except that the availability
of the funds for such grants is subject to section 300ff–28(a)(2)(H) of this title as applied for
such year.
(c) Formula grants; cancellation of unobligated
balance of grant award; waiver permitting
carryover
(1) In general
Effective for fiscal year 2007 and subsequent
fiscal years, if a grant award made to a State
for a fiscal year pursuant to section
300ff–28(a)(1) or 300ff–28(a)(2)(F)(i) of this title
has an unobligated balance as of the end of the
grant year for the award, the Secretary shall
cancel that unobligated balance of the award,
and shall require the State to return any
amounts from such balance that have been
disbursed to the State, unless—
(A) before the end of the grant year, the
State submits to the Secretary a written application for a waiver of the cancellation,
which application includes a description of
the purposes for which the State intends to
expend the funds involved; and
(B) the Secretary approves the waiver.
(2) Expenditure by end of carryover year
With respect to a waiver under paragraph (1)
that is approved for a balance that is unobligated as of the end of a grant year for an
award:
(A) The unobligated funds are available for
expenditure by the State involved for the
one-year period beginning upon the expiration of the grant year (referred to in this
section as the ‘‘carryover year’’).
(B) If the funds are not expended by the
end of the carryover year, the Secretary
shall cancel that unexpended balance of the

Page 1251

TITLE 42—THE PUBLIC HEALTH AND WELFARE

award, and shall require the State to return
any amounts from such balance that have
been disbursed to the State.
(3) Use of cancelled balances
In the case of any balance of a grant award
that is cancelled under paragraph (1) or (2)(B),
the grant funds involved shall be made available by the Secretary as additional amounts
for grants under section 300ff–29a of this title
for the first fiscal year beginning after the fiscal year in which the Secretary obtains the information necessary for determining that the
balance is required under such paragraph to be
canceled, except that the availability of the
funds for such grants is subject to section
300ff–28(a)(2)(H) of this title as applied for such
year.
(4) Corresponding reduction in future grant
(A) In general
In the case of a State for which a balance
from a grant award made pursuant to section 300ff–28(a)(1) or 300ff–28(a)(2)(F)(i) of this
title is unobligated as of the end of the grant
year for the award—
(i) the Secretary shall reduce, by the
same amount as such unobligated balance
(less any amount of such balance that is
the subject of a waiver of cancellation
under paragraph (1)), the amount of the
grant under such section for the first fiscal
year beginning after the fiscal year in
which the Secretary obtains the information necessary for determining that such
balance was unobligated as of the end of
the grant year (which requirement for a
reduction applies without regard to whether a waiver under paragraph (1) has been
approved with respect to such balance);
and
(ii) the grant funds involved in such reduction shall be made available by the
Secretary as additional funds for grants
under section 300ff–29a of this title for such
first fiscal year, subject to section
300ff–28(a)(2)(H) of this title;
except that this subparagraph does not apply
to the State if the amount of the unobligated balance was 5 percent or less.
(B) Relation to increases in grant
A reduction under subparagraph (A) for a
State for a fiscal year may not be taken into
account in applying section 300ff–28(a)(2)(H)
of this title with respect to the State for the
subsequent fiscal year.
(d) Treatment of drug rebates
For purposes of this section, funds that are
drug rebates referred to in section 300ff–26(g) of
this title may not be considered part of any
grant award referred to in subsection (a). If an
expenditure of ADAP rebate funds would trigger
a penalty under this section or a higher penalty
than would otherwise have applied, the State
may request that for purposes of this section,
the Secretary deem the State’s unobligated balance to be reduced by the amount of rebate
funds in the proposed expenditure. Notwithstanding 300ff–28(a)(2)(F) 1 of this title, any unob1 So

in original. Probably should be preceded by ‘‘section’’.

§ 300ff–31a

ligated
amount
under
section
300ff–28(a)(2)(F)(ii)(V) of this title that is returned to the Secretary for reallocation shall be
used by the Secretary for—
(1) the ADAP supplemental program if the
Secretary determines appropriate; or
(2) for additional amounts for grants pursuant to section 300ff–29a of this title.
(e) Authority regarding administration of provisions
In administering subsections (b) and (c) with
respect to the unobligated balance of a State,
the Secretary may elect to reduce the amount of
future grants to the State under section 300ff–28,
300ff–29a, or 300ff–30 of this title, as applicable,
by the amount of any such unobligated balance
in lieu of cancelling such amount as provided for
in subsection (b) or (c)(1). In such case, the Secretary may permit the State to use such unobligated balance for purposes of any such future
grant. An amount equal to such reduction shall
be available for use as additional amounts for
grants pursuant to section 300ff–29a of this title,
subject to section 300ff–28(a)(2)(H) of this title.
Nothing in this paragraph shall be construed to
affect the authority of the Secretary under subsections (b) and (c), including the authority to
grant waivers under subsection (c)(1). The reduction in future grants authorized under this subsection shall be notwithstanding the penalty required under subsection (c)(4) with respect to
unobligated funds.
(July 1, 1944, ch. 373, title XXVI, § 2622, as added
and amended Pub. L. 109–415, title II, § 207, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2799, 2820; Pub.
L. 111–87, §§ 2(a)(1), (3)(A), 5(c)(2)–(4), 8(b)(1)(B),
(2)(B), (c)(2), 10(a), Oct. 30, 2009, 123 Stat. 2885,
2891, 2894, 2895.)
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a). Pub. L. 111–87, § 5(c)(3), substituted
‘‘300ff–28(a)(2)(F)’’ for ‘‘300ff–28(a)(2)(G)’’.
Subsec. (b). Pub. L. 111–87, § 5(c)(4), substituted
‘‘300ff–28(a)(2)(F)(ii)’’ for ‘‘300ff–28(a)(2)(G)(ii)’’ in introductory provisions.
Subsec. (c)(1). Pub. L. 111–87, § 5(c)(2), substituted
‘‘300ff–28(a)(2)(F)(i)’’ for ‘‘300ff–28(a)(2)(G)(i)’’ in introductory provisions.
Subsec. (c)(4)(A). Pub. L. 111–87, §§ 5(c)(2), 8(b)(1)(B),
substituted
‘‘300ff–28(a)(2)(F)(i)’’
for
‘‘300ff–28(a)(2)(G)(i)’’ in introductory provisions and ‘‘5
percent’’ for ‘‘2 percent’’ in concluding provisions.
Subsec. (c)(4)(A)(i). Pub. L. 111–87, § 8(c)(2), inserted
‘‘(less any amount of such balance that is the subject
of a waiver of cancellation under paragraph (1))’’ after
‘‘unobligated balance’’.
Subsec. (d). Pub. L. 111–87, § 10(a), inserted at end ‘‘If
an expenditure of ADAP rebate funds would trigger a
penalty under this section or a higher penalty than
would otherwise have applied, the State may request
that for purposes of this section, the Secretary deem
the State’s unobligated balance to be reduced by the
amount of rebate funds in the proposed expenditure.
Notwithstanding 300ff–28(a)(2)(F) of this title, any unobligated amount under section 300ff–28(a)(2)(F)(ii)(V)
of this title that is returned to the Secretary for reallocation shall be used by the Secretary for—
‘‘(1) the ADAP supplemental program if the Secretary determines appropriate; or

§ 300ff–31b

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) for additional amounts for grants pursuant to
section 300ff–29a of this title.’’
Subsec. (e). Pub. L. 111–87, § 8(b)(2)(B), added subsec.
(e).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 5(c)(2)–(4), 8(b)(1)(B), (2)(B), (c)(2), and 10(a)
of Pub. L. 111–87 be applicable to this section as so revived and effective as if enacted on Sept. 30, 2009, see
section 2(a)(2), (3) of Pub. L. 111–87, set out as a note
under section 300ff–1 of this title.

§ 300ff–31b. Authorization of appropriations
(a) In general
For the purpose of carrying out this subpart,
there are authorized to be appropriated
$1,195,500,000 for fiscal year 2007, $1,239,500,000 for
fiscal year 2008, $1,285,200,000 for fiscal year 2009,
$1,349,460,000 for fiscal year 2010, $1,416,933,000 for
fiscal year 2011, $1,487,780,000 for fiscal year 2012,
and $1,562,169,000 for fiscal year 2013. Amounts
appropriated under the preceding sentence for a
fiscal year are available for obligation by the
Secretary until the end of the second succeeding
fiscal year.
(b) Reservation of amounts
(1) Emerging communities
Of the amount appropriated under subsection (a) for a fiscal year, the Secretary
shall reserve $5,000,000 for grants under section
300ff–30 of this title.
(2) Supplemental grants
(A) In general
Of the amount appropriated under subsection (a) for a fiscal year in excess of the
2006 adjusted amount, the Secretary shall reserve 1⁄3 for grants under section 300ff–29a of
this title, except that the availability of the
reserved funds for such grants is subject to
section 300ff–28(a)(2)(H) of this title as applied for such year, and except that any
amount appropriated exclusively for carrying out section 300ff–26 of this title (and, accordingly,
distributed
under
section
300ff–28(a)(2)(F) of this title) is not subject to
this subparagraph.
(B) 2006 adjusted amount
For purposes of subparagraph (A), the term
‘‘2006 adjusted amount’’ means the amount
appropriated for fiscal year 2006 under section 300ff–77(b) of this title (as such section
was in effect for such fiscal year), excluding
any amount appropriated for such year exclusively for carrying out section 300ff–26 of
this title (and, accordingly, distributed
under section 300ff–28(a)(2)(I) of this title, as
so in effect).
(July 1, 1944, ch. 373, title XXVI, § 2623, as added
and amended Pub. L. 109–415, title II, § 208, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2801, 2820; Pub.
L. 111–87, §§ 2(a)(1), (3)(A), (c), 5(c)(3), Oct. 30,
2009, 123 Stat. 2885, 2891.)

Page 1252

AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a). Pub. L. 111–87, § 2(c), substituted
‘‘$1,285,200,000 for fiscal year 2009, $1,349,460,000 for fiscal
year 2010, $1,416,933,000 for fiscal year 2011, $1,487,780,000
for fiscal year 2012, and $1,562,169,000 for fiscal year
2013’’ for ‘‘and $1,285,200,000 for fiscal year 2009’’.
Subsec. (b)(2)(A). Pub. L. 111–87, § 5(c)(3), substituted
‘‘300ff–28(a)(2)(F)’’ for ‘‘300ff–28(a)(2)(G)’’.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 2(c) and 5(c)(3) of Pub. L. 111–87 be applicable to this section as so revived and effective as if enacted on Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L.
111–87, set out as a note under section 300ff–11 of this
title.
SUBPART II—PROVISIONS CONCERNING PREGNANCY
AND PERINATAL TRANSMISSION OF HIV

§ 300ff–33. Early diagnosis grant program
(a) In general
In the case of States whose laws or regulations
are in accordance with subsection (b), the Secretary, acting through the Centers for Disease
Control and Prevention, shall make grants to
such States for the purposes described in subsection (c).
(b) Description of compliant States
For purposes of subsection (a), the laws or regulations of a State are in accordance with this
subsection if, under such laws or regulations (including programs carried out pursuant to the
discretion of State officials), both of the policies
described in paragraph (1) are in effect, or both
of the policies described in paragraph (2) are in
effect, as follows:
(1)(A) Voluntary opt-out testing of pregnant
women.
(B) Universal testing of newborns.
(2)(A) Voluntary opt-out testing of clients at
sexually transmitted disease clinics.
(B) Voluntary opt-out testing of clients at
substance abuse treatment centers.
The Secretary shall periodically ensure that the
applicable policies are being carried out and recertify compliance.
(c) Use of funds
A State may use funds provided under subsection (a) for HIV/AIDS testing (including rapid
testing), prevention counseling, treatment of
newborns exposed to HIV/AIDS, treatment of
mothers infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/
AIDS to care and treatment for HIV/AIDS.
(d) Application
A State that is eligible for the grant under
subsection (a) shall submit an application to the
Secretary, in such form, in such manner, and

Page 1253

TITLE 42—THE PUBLIC HEALTH AND WELFARE

containing such information as the Secretary
may require.
(e) Limitation on amount of grant
A grant under subsection (a) to a State for a
fiscal year may not be made in an amount exceeding $10,000,000.
(f) Rule of construction
Nothing in this section shall be construed to
pre-empt State laws regarding HIV/AIDS counseling and testing.
(g) Definitions
In this section:
(1) The term ‘‘voluntary opt-out testing’’
means HIV/AIDS testing—
(A) that is administered to an individual
seeking other health care services; and
(B) in which—
(i) pre-test counseling is not required but
the individual is informed that the individual will receive an HIV/AIDS test and the
individual may opt out of such testing; and
(ii) for those individuals with a positive
test result, post-test counseling (including
referrals for care) is provided and confidentiality is protected.
(2) The term ‘‘universal testing of newborns’’
means HIV/AIDS testing that is administered
within 48 hours of delivery to—
(A) all infants born in the State; or
(B) all infants born in the State whose
mother’s HIV/AIDS status is unknown at the
time of delivery.
(h) Authorization of appropriations
Of the funds appropriated annually to the Centers for Disease Control and Prevention for HIV/
AIDS prevention activities, $30,000,000 shall be
made available for each of the fiscal years 2007
through 2009 for grants under subsection (a), of
which $20,000,000 shall be made available for
grants to States with the policies described in
subsection (b)(1), and $10,000,000 shall be made
available for grants to States with the policies
described in subsection (b)(2). Funds provided
under this section are available until expended.
(July 1, 1944, ch. 373, title XXVI, § 2625, as added
Pub. L. 104–146, § 7(b)(3), May 20, 1996, 110 Stat.
1369; amended Pub. L. 106–345, title II, § 212(a),
Oct. 20, 2000, 114 Stat. 1339; Pub. L. 109–415, title
II, § 209, title VII, § 703, Dec. 19, 2006, 120 Stat.
2802, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30,
2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 209, amended section catchline and
text generally, substituting provisions relating to early
diagnosis grant program for provisions requiring State
certification of measures to adopt CDC guidelines for
pregnant women not later than 120 days after May 20,
1996, and authorizing additional funds if such certification was provided.
2000—Subsec. (c)(1)(F). Pub. L. 106–345, § 212(a)(1),
added subpar. (F).

§ 300ff–34

Subsec. (c)(2). Pub. L. 106–345, § 212(a)(2), amended
heading and text of par. (2) generally. Prior to amendment, text read as follows: ‘‘For purposes of carrying
out this subsection, there are authorized to be appropriated $10,000,000 for each of the fiscal years 1996
through 2000. Amounts made available under section
300ff–77 of this title for carrying out this part are not
available for carrying out this section unless otherwise
authorized.’’
Subsec. (c)(4). Pub. L. 106–345, § 212(a)(3), added par.
(4).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1996, see section 13 of Pub. L.
104–146, set out as an Effective Date of 1996 Amendment
note under section 300ff–11 of this title.
PERINATAL TRANSMISSION OF HIV DISEASE;
CONGRESSIONAL FINDINGS
Section 7(a) of Pub. L. 104–146 provided that: ‘‘The
Congress finds as follows:
‘‘(1) Research studies and statewide clinical experiences have demonstrated that administration of antiretroviral medication during pregnancy can significantly reduce the transmission of the human immunodeficiency virus (commonly known as HIV)
from an infected mother to her baby.
‘‘(2) The Centers for Disease Control and Prevention
have recommended that all pregnant women receive
HIV counseling; voluntary, confidential HIV testing;
and appropriate medical treatment (including antiretroviral therapy) and support services.
‘‘(3) The provision of such testing without access to
such counseling, treatment, and services will not improve the health of the woman or the child.
‘‘(4) The provision of such counseling, testing,
treatment, and services can reduce the number of pediatric cases of acquired immune deficiency syndrome, can improve access to and provision of medical care for the woman, and can provide opportunities
for counseling to reduce transmission among adults,
and from mother to child.
‘‘(5) The provision of such counseling, testing,
treatment, and services can reduce the overall cost of
pediatric cases of acquired immune deficiency syndrome.
‘‘(6) The cancellation or limitation of health insurance or other health coverage on the basis of HIV
status should be impermissible under applicable law.
Such cancellation or limitation could result in disincentives for appropriate counseling, testing, treatment, and services.
‘‘(7) For the reasons specified in paragraphs (1)
through (6)—
‘‘(A) routine HIV counseling and voluntary testing of pregnant women should become the standard
of care; and
‘‘(B) the relevant medical organizations as well as
public health officials should issue guidelines making such counseling and testing the standard of
care.’’

§ 300ff–34. Perinatal transmission of HIV/AIDS;
contingent requirement regarding State
grants under this part
(a) Annual determination of reported cases
A State shall annually determine the rate of
reported cases of AIDS as a result of perinatal
transmission among residents of the State.

§§ 300ff–35, 300ff–36

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Causes of perinatal transmission
In determining the rate under subsection (a) of
this section, a State shall also determine the
possible causes of perinatal transmission. Such
causes may include—
(1) the inadequate provision within the State
of prenatal counseling and testing in accordance with the guidelines issued by the Centers
for Disease Control and Prevention;
(2) the inadequate provision or utilization
within the State of appropriate therapy or
failure of such therapy to reduce perinatal
transmission of HIV, including—
(A) that therapy is not available, accessible or offered to mothers; or
(B) that available therapy is offered but
not accepted by mothers; or

Page 1254

§§ 300ff–35, 300ff–36. Repealed. Pub. L. 106–345,
title II, § 211(2), Oct. 20, 2000, 114 Stat. 1339
Section 300ff–35, act July 1, 1944, ch. 373, title XXVI,
§ 2627, as added Pub. L. 104–146, § 7(b)(3), May 20, 1996, 110
Stat. 1371, related to testing of pregnant women and
newborn infants for HIV disease.
Section 300ff–36, act July 1, 1944, ch. 373, title XXVI,
§ 2628, as added Pub. L. 104–146, § 7(b)(3), May 20, 1996, 110
Stat. 1372, related to report to Congress by Institute of
Medicine.

§ 300ff–37. State HIV testing programs established prior to or after May 20, 1996
Nothing in this subpart shall be construed to
disqualify a State from receiving grants under
this subchapter if such State has established at
any time prior to or after May 20, 1996, a program of mandatory HIV testing.

(3) other factors (which may include the lack
of prenatal care) determined relevant by the
State.
(c) CDC reporting system
Not later than 4 months after May 20, 1996, the
Director of the Centers for Disease Control and
Prevention shall develop and implement a system to be used by States to comply with the requirements of subsections (a) and (b) of this section. The Director shall issue guidelines to ensure that the data collected is statistically
valid.

A prior section 2627 of act July 1, 1944, was classified
to section 300ff–35 of this title prior to repeal by Pub.
L. 106–345.

(July 1, 1944, ch. 373, title XXVI, § 2626, as added
Pub. L. 104–146, § 7(b)(3), May 20, 1996, 110 Stat.
1369; amended Pub. L. 104–166, § 5(1), July 29, 1996,
110 Stat. 1449; Pub. L. 106–345, title II, § 211(1),
Oct. 20, 2000, 114 Stat. 1339; Pub. L. 109–415, title
VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2820;
Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123
Stat. 2885.)

2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.

AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ in section catchline.
2000—Subsecs. (d) to (f). Pub. L. 106–345 struck out
subsecs. (d) to (f), which related, respectively, to determination by Secretary, contingent applicability, and
limitation regarding availability of funds.
1996—Subsec. (d). Pub. L. 104–166, § 5(1)(A), substituted
‘‘(1) through (4)’’ for ‘‘(1) through (5)’’.
Subsec. (f). Pub. L. 104–166, § 5(1)(B), substituted ‘‘(1)
through (4)’’ for ‘‘(1) through (5)’’ in introductory provisions.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE
Section effective May 20, 1996, see section 13(b) of
Pub. L. 104–146, set out as an Effective Date of 1996
Amendment note under section 300ff–11 of this title.

(July 1, 1944, ch. 373, title XXVI, § 2627, formerly
§ 2629, as added Pub. L. 104–146, § 7(b)(3), May 20,
1996, 110 Stat. 1372; renumbered § 2627, Pub. L.
106–345, title II, § 211(3), Oct. 20, 2000, 114 Stat.
1339; amended Pub. L. 109–415, title VII, § 703,
Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
PRIOR PROVISIONS

AMENDMENTS

EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1996, see section 13 of Pub. L.
104–146, set out as an Effective Date of 1996 Amendment
note under section 300ff–11 of this title.

§ 300ff–37a. Recommendations for reducing incidence of perinatal transmission
(a) Study by Institute of Medicine
(1) In general
The Secretary shall request the Institute of
Medicine to enter into an agreement with the
Secretary under which such Institute conducts
a study to provide the following:
(A) For the most recent fiscal year for
which the information is available, a determination of the number of newborn infants
with HIV born in the United States with respect to whom the attending obstetrician for
the birth did not know the HIV status of the
mother.
(B) A determination for each State of any
barriers, including legal barriers, that pre-

Page 1255

TITLE 42—THE PUBLIC HEALTH AND WELFARE

vent or discourage an obstetrician from
making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn infants for HIV/AIDS in
circumstances in which the obstetrician
does not know the HIV status of the mother
of the infant.
(C) Recommendations for each State for
reducing the incidence of cases of the perinatal transmission of HIV, including recommendations on removing the barriers identified under subparagraph (B).
If such Institute declines to conduct the study,
the Secretary shall enter into an agreement
with another appropriate public or nonprofit
private entity to conduct the study.
(2) Report
The Secretary shall ensure that, not later
than 18 months after the effective date of this
section, the study required in paragraph (1) is
completed and a report describing the findings
made in the study is submitted to the appropriate committees of the Congress, the Secretary, and the chief public health official of
each of the States.
(b) Progress toward recommendations
In fiscal year 2004, the Secretary shall collect
information from the States describing the actions taken by the States toward meeting the
recommendations specified for the States under
subsection (a)(1)(C) of this section.
(c) Submission of reports to Congress
The Secretary shall submit to the appropriate
committees of the Congress reports describing
the information collected under subsection (b) of
this section.
(July 1, 1944, ch. 373, title XXVI, § 2628, as added
Pub. L. 106–345, title II, § 213, Oct. 20, 2000, 114
Stat. 1342; amended Pub. L. 109–415, title VII,
§§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2820; Pub. L.
111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
The effective date of this section, referred to in subsec. (a)(2), is Oct. 20, 2000. See section 601 of Pub. L.
106–345, set out as an Effective Date of 2000 Amendment
note under section 300ff–12 of this title.
PRIOR PROVISIONS
A prior section 2628 of act July 1, 1944, was classified
to section 300ff–36 of this title prior to repeal by Pub.
L. 106–345.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a)(1)(B). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective

§ 300ff–38

Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
SUBPART III—CERTAIN PARTNER NOTIFICATION
PROGRAMS

§ 300ff–38. Grants for partner notification programs
(a) In general
In the case of States whose laws or regulations
are in accordance with subsection (b) of this section, the Secretary, subject to subsection (c)(2)
of this section, may make grants to the States
for carrying out programs to provide partner
counseling and referral services.
(b) Description of compliant State programs
For purposes of subsection (a) of this section,
the laws or regulations of a State are in accordance with this subsection if under such laws or
regulations (including programs carried out pursuant to the discretion of State officials) the following policies are in effect:
(1) The State requires that the public health
officer of the State carry out a program of
partner notification to inform partners of individuals with HIV/AIDS that the partners
may have been exposed to the disease.
(2)(A) In the case of a health entity that provides for the performance on an individual of
a test for HIV/AIDS, or that treats the individual for the disease, the State requires, subject
to subparagraph (B), that the entity confidentially report the positive test results to the
State public health officer in a manner recommended and approved by the Director of the
Centers for Disease Control and Prevention,
together with such additional information as
may be necessary for carrying out such program.
(B) The State may provide that the requirement of subparagraph (A) does not apply to
the testing of an individual for HIV/AIDS if
the individual underwent the testing through
a program designed to perform the test and
provide the results to the individual without
the individual disclosing his or her identity to
the program. This subparagraph may not be
construed as affecting the requirement of subparagraph (A) with respect to a health entity
that treats an individual for HIV/AIDS.
(3) The program under paragraph (1) is carried out in accordance with the following:
(A) Partners are provided with an appropriate opportunity to learn that the partners
have been exposed to HIV/AIDS, subject to
subparagraph (B).
(B) The State does not inform partners of
the identity of the infected individuals involved.
(C) Counseling and testing for HIV/AIDS
are made available to the partners and to infected individuals, and such counseling includes information on modes of transmission
for the disease, including information on
prenatal and perinatal transmission and preventing transmission.
(D) Counseling of infected individuals and
their partners includes the provision of in-

§§ 300ff–41 to 300ff–50

TITLE 42—THE PUBLIC HEALTH AND WELFARE

formation regarding therapeutic measures
for preventing and treating the deterioration of the immune system and conditions
arising from the disease, and the provision
of other prevention-related information.
(E) Referrals for appropriate services are
provided to partners and infected individuals, including referrals for support services
and legal aid.
(F) Notifications under subparagraph (A)
are provided in person, unless doing so is an
unreasonable burden on the State.
(G) There is no criminal or civil penalty
on, or civil liability for, an infected individual if the individual chooses not to identify
the partners of the individual, or the individual does not otherwise cooperate with
such program.
(H) The failure of the State to notify partners is not a basis for the civil liability of
any health entity who under the program reported to the State the identity of the infected individual involved.
(I) The State provides that the provisions
of the program may not be construed as prohibiting the State from providing a notification under subparagraph (A) without the
consent of the infected individual involved.
(4) The State annually reports to the Director of the Centers for Disease Control and Prevention the number of individuals from whom
the names of partners have been sought under
the program under paragraph (1), the number
of such individuals who provided the names of
partners, and the number of partners so named
who were notified under the program.
(5) The State cooperates with such Director
in carrying out a national program of partner
notification, including the sharing of information between the public health officers of the
States.
(c) Reporting system for cases of HIV/AIDS; preference in making grants
In making grants under subsection (a) of this
section, the Secretary shall give preference to
States whose reporting systems for cases of HIV/
AIDS produce data on such cases that is sufficiently accurate and reliable for use for purposes of section 300ff–28(a)(2)(D)(i) of this title.
(d) Authorization of appropriations
For the purpose of carrying out this section,
there is authorized to be appropriated $10,000,000
for each of the fiscal years 2007 through 2009.
(July 1, 1944, ch. 373, title XXVI, § 2631, as added
Pub. L. 106–345, title II, § 221, Oct. 20, 2000, 114
Stat. 1343; amended Pub. L. 109–415, title II, § 210,
title VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2803,
2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009,
123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsecs. (b), (c). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’ wherever appearing.

Page 1256

Subsec. (d). Pub. L. 109–415, § 210, substituted ‘‘there is
authorized to be appropriated $10,000,000 for each of the
fiscal years 2007 through 2009.’’ for ‘‘there are authorized to be appropriated $30,000,000 for fiscal year 2001,
and such sums as may be necessary for each of the fiscal years 2002 through 2005.’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

PART C—EARLY INTERVENTION SERVICES
§§ 300ff–41 to 300ff–50. Repealed. Pub. L. 106–345,
title III, § 301(a), Oct. 20, 2000, 114 Stat. 1345
Section 300ff–41, act July 1, 1944, ch. 373, title XXVI,
§ 2641, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 597; amended Pub. L. 102–531, title III,
§ 312(d)(31), Oct. 27, 1992, 106 Stat. 3506, established program of formula grants to States.
Section 300ff–42, act July 1, 1944, ch. 373, title XXVI,
§ 2642, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 599, related to provision of services
through medicaid providers.
Section 300ff–43, act July 1, 1944, ch. 373, title XXVI,
§ 2643, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 600; amended Pub. L. 102–531, title III,
§ 312(d)(32), Oct. 27, 1992, 106 Stat. 3506, related to requirement of matching funds.
Section 300ff–44, act July 1, 1944, ch. 373, title XXVI,
§ 2644, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 601, related to the offering and encouraging of early intervention services.
Section 300ff–45, act July 1, 1944, ch. 373, title XXVI,
§ 2645, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 602, related to notification of certain individuals receiving blood transfusions.
Section 300ff–46, act July 1, 1944, ch. 373, title XXVI,
§ 2646, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 602, related to reporting and partner notification.
Section 300ff–47, act July 1, 1944, ch. 373, title XXVI,
§ 2647, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 603; amended Pub. L. 101–502, § 6(c), Nov.
3, 1990, 104 Stat. 1291; Pub. L. 104–146, § 12(c)(4), May 20,
1996, 110 Stat. 1373, related to requirement of State law
protection against intentional transmission.
Section 300ff–48, act July 1, 1944, ch. 373, title XXVI,
§ 2648, formerly Pub. L. 100–607, title IX, § 902, Nov. 4,
1988, 102 Stat. 3171; amended Pub. L. 100–690, title II,
§ 2605(a), Nov. 18, 1988, 102 Stat. 4234; renumbered § 2648
and amended Pub. L. 101–381, title III, § 301(b), Aug. 18,
1990, 104 Stat. 614; Pub. L. 104–146, § 12(c)(5), May 20, 1996,
110 Stat. 1374, related to testing and other early intervention services for State prisoners.
Section 300ff–49, act July 1, 1944, ch. 373, title XXVI,
§ 2649, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 604; amended Pub. L. 101–502, § 6(b), Nov.
3, 1990, 104 Stat. 1290; Pub. L. 102–531, title III,
§ 312(d)(33), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 104–146,
§ 12(c)(6), May 20, 1996, 110 Stat. 1374, related to determination of amount of allotments.
Section 300ff–49a, act July 1, 1944, ch. 373, title XXVI,
§ 2649A, as added Pub. L. 101–381, title III, § 301(a), Aug.
18, 1990, 104 Stat. 605, related to miscellaneous prerequisites for the Secretary to make a grant.
Section 300ff–50, act July 1, 1944, ch. 373, title XXVI,
§ 2650, as added Pub. L. 101–381, title III, § 301(a), Aug. 18,
1990, 104 Stat. 606, authorized appropriations.
SUBPART I—CATEGORICAL GRANTS

AMENDMENTS
Pub. L. 106–345, title III, § 301(b)(1), Oct. 20, 2000, 114
Stat. 1345, redesignated subpart II as subpart I.

Page 1257

TITLE 42—THE PUBLIC HEALTH AND WELFARE
PRIOR PROVISIONS

A prior subpart I, consisting of sections 300ff–41 to
300ff–50, related to formula grants for States, prior to
repeal by Pub. L. 106–345, title III, § 301(a), Oct. 20, 2000,
114 Stat. 1345.

§ 300ff–51. Establishment of a program
(a) In general
For the purposes described in subsection (b),
the Secretary, acting through the Administrator
of the Health Resources and Services Administration, may make grants to public and nonprofit private entities specified in section
300ff–52(a) of this title.
(b) Requirements
(1) In general
The Secretary may not make a grant under
subsection (a) unless the applicant for the
grant agrees to expend the grant only for—
(A) core medical services described in subsection (c);
(B) support services described in subsection (d); and
(C) administrative expenses as described in
section 300ff–64(g)(3) of this title.
(2) Early intervention services
An applicant for a grant under subsection (a)
shall expend not less than 50 percent of the
amount received under the grant for the services described in subparagraphs (B) through
(E) of subsection (e)(1) for individuals with
HIV/AIDS.
(c) Required funding for core medical services
(1) In general
With respect to a grant under subsection (a)
to an applicant for a fiscal year, the applicant
shall, of the portion of the grant remaining
after reserving amounts for purposes of paragraphs (3) and (5) of section 300ff–64(g) of this
title, use not less than 75 percent to provide
core medical services that are needed in the
area involved for individuals with HIV/AIDS
who are identified and eligible under this subchapter (including services regarding the cooccurring conditions of the individuals).
(2) Waiver
(A) The Secretary shall waive the application of paragraph (1) with respect to an applicant for a grant if the Secretary determines
that, within the service area of the applicant—
(i) there are no waiting lists for AIDS Drug
Assistance Program services under section
300ff–26 of this title; and
(ii) core medical services are available to
all individuals with HIV/AIDS identified and
eligible under this subchapter.
(B) NOTIFICATION OF WAIVER STATUS.—When
informing an applicant that a grant under subsection (a) is being made for a fiscal year, the
Secretary shall inform the applicant whether
a waiver under subparagraph (A) is in effect
for the fiscal year.
(3) Core medical services
For purposes of this subsection, the term
‘‘core medical services’’, with respect to an individual with HIV/AIDS (including the co-oc-

§ 300ff–51

curring conditions of the individual) means
the following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments under section 300ff–26 of this title.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (e).
(F) Health insurance premium and cost
sharing assistance for low-income individuals in accordance with section 300ff–25 of
this title.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 300ff–24(c)
of this title.
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(d) Support services
(1) In general
For purposes of this section, the term ‘‘support services’’ means services, subject to the
approval of the Secretary, that are needed for
individuals with HIV/AIDS to achieve their
medical outcomes (such as respite care for persons caring for individuals with HIV/AIDS,
outreach services, medical transportation, linguistic services, and referrals for health care
and support services).
(2) Definition of medical outcomes
In this section, the term ‘‘medical outcomes’’ means those outcomes affecting the
HIV-related clinical status of an individual
with HIV/AIDS.
(e) Specification of early intervention services
(1) In general
The early intervention services referred to
in this section are—
(A) counseling individuals with respect to
HIV/AIDS in accordance with section 300ff–62
of this title;
(B) testing individuals with respect to HIV/
AIDS, including tests to confirm the presence of the disease, tests to diagnose the extent of the deficiency in the immune system,
and tests to provide information on appropriate therapeutic measures for preventing
and treating the deterioration of the immune system and for preventing and treating conditions arising from HIV/AIDS;
(C) referrals described in paragraph (2);
(D) other clinical and diagnostic services
regarding HIV/AIDS, and periodic medical
evaluations of individuals with HIV/AIDS;
and
(E) providing the therapeutic measures described in subparagraph (B).
(2) Referrals
The services referred to in paragraph (1)(C)
are referrals of individuals with HIV/AIDS to
appropriate providers of health and support
services, including, as appropriate—

§ 300ff–52

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) to entities receiving amounts under
part A or B for the provision of such services;
(B) to biomedical research facilities of institutions of higher education that offer
experimental treatment for such disease, or
to community-based organizations or other
entities that provide such treatment; or
(C) to grantees under section 300ff–71 of
this title, in the case of a pregnant woman.
(3) Requirement of availability of all early
intervention services through each grantee
(A) In general
The Secretary may not make a grant
under subsection (a) unless the applicant for
the grant agrees that each of the early intervention services specified in paragraph (2)
will be available through the grantee. With
respect to compliance with such agreement,
such a grantee may expend the grant to provide the early intervention services directly,
and may expend the grant to enter into
agreements with public or nonprofit private
entities, or private for-profit entities if such
entities are the only available provider of
quality HIV care in the area, under which
the entities provide the services.
(B) Other requirements
Grantees described in—
(i) subparagraphs (A), (D), (E), and (F) of
section 300ff–52(a)(1) of this title shall use
not less than 50 percent of the amount of
such a grant to provide the services described in subparagraphs (A), (B), (D), and
(E) of paragraph (1) directly and on-site or
at sites where other primary care services
are rendered; and
(ii) subparagraphs (B) and (C) of section
300ff–52(a)(1) of this title shall ensure the
availability of early intervention services
through a system of linkages to community-based primary care providers, and to
establish mechanisms for the referrals described in paragraph (1)(C), and for followup concerning such referrals.
(July 1, 1944, ch. 373, title XXVI, § 2651, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 606; amended Pub. L. 101–557, title IV,
§ 401(b)(2), Nov. 15, 1990, 104 Stat. 2771; Pub. L.
104–146, §§ 3(d)(1), 12(c)(7), May 20, 1996, 110 Stat.
1357, 1374; Pub. L. 109–415, title III, § 301(a), title
VII, § 703, Dec. 19, 2006, 120 Stat. 2803, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 301(a), amended section catchline
and text generally, reenacting subsec. (a) without
change and substituting subsecs. (b) to (e) for former
subsecs. (b) and (c), which related to purposes of grants
and participation in a consortium, respectively.
1996—Subsec. (b)(1). Pub. L. 104–146, § 3(d)(1)(A), inserted before period ‘‘, and unless the applicant agrees

Page 1258

to expend not less than 50 percent of the grant for such
services that are specified in subparagraphs (B) through
(E) of such paragraph for individuals with HIV disease’’.
Subsec. (b)(3)(B). Pub. L. 104–146, § 12(c)(7)(A), substituted ‘‘facilities’’ for ‘‘facility’’.
Subsec. (b)(4). Pub. L. 104–146, § 3(d)(1)(B), designated
existing provisions as subpar. (A) and inserted heading,
inserted ‘‘, or private for-profit entities if such entities
are the only available provider of quality HIV care in
the area,’’ after ‘‘nonprofit private entities’’, realigned
margin, and added subpar. (B).
Subsec. (c). Pub. L. 104–146, § 12(c)(7)(B), substituted
‘‘exists’’ for ‘‘exist’’.
1990—Subsec. (a). Pub. L. 101–557 substituted ‘‘section
300ff–52(a)’’ for ‘‘section 300ff–52(a)(1)’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–52. Minimum qualifications of grantees
(a) Eligible entities
(1) In general
The entities referred to in section 300ff–51(a)
of this title are public entities and nonprofit
private entities that are—
(A) federally-qualified health centers
under section 1905(l)(2)(B) of the Social Security Act [42 U.S.C. 1396d(l)(2)(B)];
(B) grantees under section 300 of this title
(regarding family planning) other than
States;
(C) comprehensive hemophilia diagnostic
and treatment centers;
(D) rural health clinics;
(E) health facilities operated by or pursuant to a contract with the Indian Health
Service;
(F) community-based organizations, clinics, hospitals and other health facilities that
provide early intervention services to those
persons infected with HIV/AIDS through intravenous drug use; or
(G) nonprofit private entities that provide
comprehensive primary care services to populations at risk of HIV/AIDS, including
faith-based and community-based organizations.
(2) Underserved populations
Entities described in paragraph (1) shall
serve underserved populations which may include minority populations and Native American populations, ex-offenders, individuals
with comorbidities including hepatitis B or C,
mental illness, or substance abuse, low-income
populations, inner city populations, and rural
populations.
(b) Status as medicaid provider
(1) In general
Subject to paragraph (2), the Secretary may
not make a grant under section 300ff–51 of this

Page 1259

TITLE 42—THE PUBLIC HEALTH AND WELFARE

title for the provision of services described in
subsection (b) of such section in a State unless, in the case of any such service that is
available pursuant to the State plan approved
under title XIX of the Social Security Act [42
U.S.C. 1396 et seq.] for the State—
(A) the applicant for the grant will provide
the service directly, and the applicant has
entered into a participation agreement
under the State plan and is qualified to receive payments under such plan; or
(B) the applicant for the grant will enter
into an agreement with a public or nonprofit
private entity, or a private for-profit entity
if such entity is the only available provider
of quality HIV care in the area, under which
the entity will provide the service, and the
entity has entered into such a participation
agreement and is qualified to receive such
payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding
the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the
Secretary if the entity does not, in providing
health care services, impose a charge or accept
reimbursement available from any third-party
payor, including reimbursement under any insurance policy or under any Federal or State
health benefits program.
(B) A determination by the Secretary of
whether an entity referred to in subparagraph
(A) meets the criteria for a waiver under such
subparagraph shall be made without regard to
whether the entity accepts voluntary donations regarding the provision of services to the
public.
(July 1, 1944, ch. 373, title XXVI, § 2652, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 607; amended Pub. L. 101–557, title IV,
§ 401(b)(3), Nov. 15, 1990, 104 Stat. 2771; Pub. L.
104–146, § 3(d)(2), May 20, 1996, 110 Stat. 1357; Pub.
L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat.
1664; Pub. L. 108–163, § 2(m)(3), Dec. 6, 2003, 117
Stat. 2023; Pub. L. 109–415, title III, § 302(a), title
VII, § 703, Dec. 19, 2006, 120 Stat. 2806, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (b)(1),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XIX of the
Social Security Act is classified generally to subchapter XIX (§ 1396 et seq.) of chapter 7 of this title. For
complete classification of this Act to the Code, see section 1305 of this title and Tables.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a). Pub. L. 109–415, § 302(a), amended heading
and text of subsec. (a) generally, substituting provisions listing eligible entities and directing that such

§ 300ff–53

entities serve underserved populations for provisions
listing eligible entities.
2003—Subsec. (a)(2). Pub. L. 108–163 substituted
‘‘254b(h)’’ for ‘‘256’’.
2002—Pub. L. 107–251, which directed the substitution
of ‘‘254b(h)’’ for ‘‘256’’ in subsec. (2), could not be executed because section does not contain a subsec. (2).
1996—Subsec. (b)(1)(B). Pub. L. 104–146 inserted ‘‘, or a
private for-profit entity if such entity is the only available provider of quality HIV care in the area,’’ after
‘‘nonprofit private entity’’.
1990—Subsec. (a). Pub. L. 101–557 substituted ‘‘referred to in section 300ff–51(a) of this title’’ for ‘‘referred to in subsection (b) of this section’’, redesignated
pars. (A) to (F) as (1) to (6), respectively, and substituted ‘‘nonprofit private entities that provide’’ for
‘‘a nonprofit private entity that provides’’ in par. (6).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–163 deemed to have taken
effect immediately after the enactment of Pub. L.
107–251, see section 3 of Pub. L. 108–163, set out as a note
under section 233 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.
REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING,
OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
Reference to community health center, migrant
health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note
under section 254b of this title.

§ 300ff–53. Preferences in making grants
(a) In general
In making grants under section 300ff–51 of this
title, the Secretary shall give preference to any
qualified applicant experiencing an increase in
the burden of providing services regarding HIV/
AIDS, as indicated by the factors specified in
subsection (b) of this section.
(b) Specification of factors
(1) In general
In the case of the geographic area with respect to which the entity involved is applying
for a grant under section 300ff–51 of this title,
the factors referred to in subsection (a) of this
section, as determined for the period specified
in paragraph (2), are—
(A) the number of cases of HIV/AIDS;
(B) the rate of increase in such cases;
(C) the lack of availability of early intervention services;
(D) the number of other cases of sexually
transmitted diseases, and 1 the number of
cases of tuberculosis and of drug abuse 2 and
1 So
2 So

in original. The word ‘‘and’’ probably should not appear.
in original. A comma probably should appear.

§ 300ff–54

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the number of cases of individuals co-infected with HIV/AIDS and hepatitis B or C;
(E) the rate of increase in each of the cases
specified in subparagraph (D);
(F) the lack of availability of primary
health services from providers other than
such applicant; and
(G) the distance between such area and the
nearest community that has an adequate
level of availability of appropriate HIV-related services, and the length of time required to travel such distance.
(2) Relevant period of time
The period referred to in paragraph (1) is the
2-year period preceding the fiscal year for
which the entity involved is applying to receive a grant under section 300ff–51 of this
title.
(c) Equitable allocations
In providing preferences for purposes of subsection (b) of this section, the Secretary shall
equitably allocate the preferences among urban
and rural areas.
(d) Certain areas
Of the applicants who qualify for preference
under this section—
(1) the Secretary shall give preference to applicants that will expend the grant under section 300ff–51 of this title to provide early intervention under such section in rural areas; and
(2) the Secretary shall give preference to
areas that are underserved with respect to
such services.
(July 1, 1944, ch. 373, title XXVI, § 2653, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 608; amended Pub. L. 106–345, title III, § 311,
Oct. 20, 2000, 114 Stat. 1345; Pub. L. 109–415, title
III, § 302(b), title VII, §§ 702(3), 703, Dec. 19, 2006,
120 Stat. 2806, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A),
Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a). Pub. L. 109–415, § 702(3), substituted ‘‘HIV/
AIDS’’ for ‘‘HIV disease’’.
Subsec. (b)(1)(A). Pub. L. 109–415, § 302(b)(1)(A), substituted ‘‘HIV/AIDS’’ for ‘‘acquired immune deficiency
syndrome’’.
Subsec. (b)(1)(D). Pub. L. 109–415, § 302(b)(1)(B), inserted ‘‘and the number of cases of individuals co-infected with HIV/AIDS and hepatitis B or C’’ before
semicolon at end.
Subsec. (d)(2). Pub. L. 109–415, § 302(b)(2), substituted
‘‘preference’’ for ‘‘special consideration’’.
2000—Subsec. (d). Pub. L. 106–345 added subsec. (d).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

Page 1260

§ 300ff–54. Miscellaneous provisions
(a) Services for individuals with hemophilia
In making grants under section 300ff–51 of this
title, the Secretary shall ensure that any such
grants made regarding the provision of early
intervention services to individuals with hemophilia are made through the network of comprehensive hemophilia diagnostic and treatment
centers.
(b) Technical assistance
The Secretary may, directly or through grants
or contracts, provide technical assistance to
nonprofit private entities regarding the process
of submitting to the Secretary applications for
grants under section 300ff–51 of this title, and
may provide technical assistance with respect to
the planning, development, and operation of any
program or service carried out pursuant to such
section.
(c) Planning and development grants
(1) In general
The Secretary may provide planning grants
to public and nonprofit private entities for
purposes of—
(A) enabling such entities to provide early
intervention services; and
(B) assisting the entities in expanding
their capacity to provide HIV/AIDS-related
health services, including early intervention
services, in low-income communities and affected subpopulations that are underserved
with respect to such services (subject to the
condition that a grant pursuant to this subparagraph may not be expended to purchase
or improve land, or to purchase, construct,
or permanently improve, other than minor
remodeling, any building or other facility).
(2) Requirement
The Secretary may only award a grant to an
entity under paragraph (1) if the Secretary determines that the entity will use such grant to
assist the entity in qualifying for a grant
under section 300ff–51 of this title.
(3) Preference
In awarding grants under paragraph (1), the
Secretary shall give preference to entities
that provide primary care services in rural
areas or to underserved populations.
(4) Amount and duration of grants
(A) Early intervention services
A grant under paragraph (1)(A) may be
made in an amount not to exceed $50,000.
(B) Capacity development
(i) Amount
A grant under paragraph (1)(B) may be
made in an amount not to exceed $150,000.
(ii) Duration
The total duration of a grant under paragraph (1)(B), including any renewal, may
not exceed 3 years.
(5) Limitation
Not to exceed 5 percent of the amount appropriated for a fiscal year under section 300ff–55
of this title may be used to carry out this section.

Page 1261

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XXVI, § 2654, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 608; amended Pub. L. 104–146, § 3(d)(3), May
20, 1996, 110 Stat. 1357; Pub. L. 106–345, title III,
§ 312, Oct. 20, 2000, 114 Stat. 1345; Pub. L. 109–415,
title III, § 302(c), title VII, § 703, Dec. 19, 2006, 120
Stat. 2807, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A),
Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (c)(1)(A). Pub. L. 109–415, § 302(c)(1)(A), struck
out ‘‘HIV’’ after ‘‘provide’’.
Subsec. (c)(1)(B). Pub. L. 109–415, § 302(c)(1)(B), substituted ‘‘HIV/AIDS-related’’ for ‘‘HIV-related’’.
Subsec. (c)(3). Pub. L. 109–415, § 302(c)(2), substituted
‘‘areas or to underserved populations’’ for ‘‘or underserved communities’’.
2000—Subsec. (c)(1). Pub. L. 106–345, § 312(a), substituted ‘‘planning grants to public and nonprofit private entities for purposes of—’’ and subpars. (A) and (B)
for ‘‘planning grants, in an amount not to exceed
$50,000 for each such grant, to public and nonprofit private entities for the purpose of enabling such entities
to provide HIV early intervention services.’’
Subsec. (c)(4). Pub. L. 106–345, § 312(b)(2), added par.
(4). Former par. (4) redesignated (5).
Subsec. (c)(5). Pub. L. 106–345, § 312(b)(1), (c), redesignated par. (4) as (5) and substituted ‘‘5 percent’’ for ‘‘1
percent’’.
1996—Subsec. (c). Pub. L. 104–146 added subsec. (c).

§ 300ff–61

year 2012, and $285,766,000 for fiscal year 2013’’ for ‘‘and
$235,100,000 for fiscal year 2009’’.
Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival Section
note below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 303, substituted ‘‘, $218,600,000 for fiscal year 2007, $226,700,000 for fiscal year 2008, and
$235,100,000 for fiscal year 2009’’ for ‘‘such sums as may
be necessary for each of the fiscal years 2001 through
2005’’.
2000—Pub. L. 106–345 substituted ‘‘for each of the fiscal years 2001 through 2005’’ for ‘‘in each of the fiscal
years 1996, 1997, 1998, 1999, and 2000’’.
1996—Pub. L. 104–146 substituted ‘‘such sums as may
be necessary in each of the fiscal years 1996, 1997, 1998,
1999, and 2000.’’ for ‘‘$75,000,000 for fiscal years 1991, and
such sums as may be necessary for each of the fiscal
years 1992 through 1995.’’
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 2(d) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION

SUBPART II—GENERAL PROVISIONS

For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

A prior subpart II, consisting of sections 300ff–51 to
300ff–55, was redesignated subpart I of this part by Pub.
L. 106–345, title III, § 301(b)(1), Oct. 20, 2000, 114 Stat.
1345.

EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–55. Authorization of appropriations
For the purpose of making grants under section 300ff–51 of this title, there are authorized to
be appropriated, $218,600,000 for fiscal year 2007,
$226,700,000 for fiscal year 2008, $235,100,000 for
fiscal year 2009, $246,855,000 for fiscal year 2010,
$259,198,000 for fiscal year 2011, $272,158,000 for
fiscal year 2012, and $285,766,000 for fiscal year
2013.
(July 1, 1944, ch. 373, title XXVI, § 2655, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 609; amended Pub. L. 104–146, § 3(d)(4), May
20, 1996, 110 Stat. 1358; Pub. L. 106–345, title III,
§ 313, Oct. 20, 2000, 114 Stat. 1346; Pub. L. 109–415,
title III, § 303, title VII, § 703, Dec. 19, 2006, 120
Stat. 2807, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A),
(d), Oct. 30, 2009, 123 Stat. 2885, 2886.)
AMENDMENTS
2009—Pub. L. 111–87, § 2(d), substituted ‘‘$235,100,000 for
fiscal year 2009, $246,855,000 for fiscal year 2010,
$259,198,000 for fiscal year 2011, $272,158,000 for fiscal

PRIOR PROVISIONS

AMENDMENTS
Pub. L. 106–345, title III, § 301(b)(1), Oct. 20, 2000, 114
Stat. 1345, redesignated subpart III as subpart II.

§ 300ff–61. Confidentiality and informed consent
(a) Confidentiality
The Secretary may not make a grant under
this part unless, in the case of any entity applying for a grant under section 300ff–51 of this
title, the entity agrees to ensure that information regarding the receipt of early intervention
services pursuant to the grant is maintained
confidentially in a manner not inconsistent with
applicable law.
(b) Informed consent
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, in testing an individual for HIV/
AIDS, the applicant will test an individual only
after the individual confirms that the decision
of the individual with respect to undergoing
such testing is voluntarily made.
(July 1, 1944, ch. 373, title XXVI, § 2661, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 609; amended Pub. L. 106–345, title III,
§ 301(b)(2), Oct. 20, 2000, 114 Stat. 1345; Pub. L.

§ 300ff–62

TITLE 42—THE PUBLIC HEALTH AND WELFARE

109–415, title III, § 304, title VII, § 703, Dec. 19,
2006, 120 Stat. 2807, 2820; Pub. L. 111–87, § 2(a)(1),
(3)(A), Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 304, reenacted section catchline
without change and amended text generally, substituting provisions relating to confidentiality and informed
consent for provisions relating to confidentiality, informed written consent, and anonymous testing.
2000—Subsec. (a). Pub. L. 106–345 struck out par. (1)
and par. (2) designation. Prior to amendment, par. (1)
read as follows: ‘‘in the case of any State applying for
a grant under section 300ff–41 of this title, the State
agrees to ensure that information regarding the receipt
of early intervention services is maintained confidentially pursuant to law or regulations in a manner not
inconsistent with applicable law; and’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–62. Provision of certain counseling services
(a) Counseling of individuals with negative test
results
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, if the results of testing conducted
for HIV/AIDS indicate that an individual does
not have such condition, the applicant will provide the individual information, including—
(1) measures for prevention of, exposure to,
and transmission of HIV/AIDS, hepatitis B,
hepatitis C, and other sexually transmitted
diseases;
(2) the accuracy and reliability of results of
testing for HIV/AIDS, hepatitis B, and hepatitis C;
(3) the significance of the results of such
testing, including the potential for developing
AIDS, hepatitis B, or hepatitis C;
(4) the appropriateness of further counseling,
testing, and education of the individual regarding HIV/AIDS and other sexually transmitted diseases;
(5) if diagnosed with chronic hepatitis B or
hepatitis C co-infection, the potential of developing hepatitis-related liver disease and its
impact on HIV/AIDS; and
(6) information regarding the availability of
hepatitis B vaccine and information about
hepatitis treatments.
(b) Counseling of individuals with positive test
results
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, if the results of testing for HIV/
AIDS indicate that the individual has such con-

Page 1262

dition, the applicant will provide to the individual appropriate counseling regarding the condition, including—
(1) information regarding—
(A) measures for prevention of, exposure
to, and transmission of HIV/AIDS, hepatitis
B, and hepatitis C;
(B) the accuracy and reliability of results
of testing for HIV/AIDS, hepatitis B, and
hepatitis C; and
(C) the significance of the results of such
testing, including the potential for developing AIDS, hepatitis B, or hepatitis C;
(2) reviewing the appropriateness of further
counseling, testing, and education of the individual regarding HIV/AIDS and other sexually
transmitted diseases; and
(3) providing counseling—
(A) on the availability, through the applicant, of early intervention services;
(B) on the availability in the geographic
area of appropriate health care, mental
health care, and social and support services,
including providing referrals for such services, as appropriate;
(C)(i) that explains the benefits of locating
and counseling any individual by whom the
infected individual may have been exposed
to HIV/AIDS, hepatitis B, or hepatitis C and
any individual whom the infected individual
may have exposed to HIV/AIDS, hepatitis B,
or hepatitis C; and
(ii) that emphasizes it is the duty of infected individuals to disclose their infected
status to their sexual partners and their
partners in the sharing of hypodermic needles; that provides advice to infected individuals on the manner in which such disclosures can be made; and that emphasizes that
it is the continuing duty of the individuals
to avoid any behaviors that will expose others to HIV/AIDS, hepatitis B, or hepatitis C;
and
(D) on the availability of the services of
public health authorities with respect to locating and counseling any individual described in subparagraph (C);
(4) if diagnosed with chronic hepatitis B or
hepatitis C co-infection, the potential of developing hepatitis-related liver disease and its
impact on HIV/AIDS; and
(5) information regarding the availability of
hepatitis B vaccine.
(c) Additional requirements regarding appropriate counseling
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, in counseling individuals with respect to HIV/AIDS, the applicant will ensure
that the counseling is provided under conditions
appropriate to the needs of the individuals.
(d) Counseling of emergency response employees
The Secretary may not make a grant under
this part to a State unless the State agrees that,
in counseling individuals with respect to HIV/
AIDS, the State will ensure that, in the case of
emergency response employees, the counseling
is provided to such employees under conditions
appropriate to the needs of the employees regarding the counseling.

Page 1263

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(e) Rule of construction regarding counseling
without testing
Agreements made pursuant to this section
may not be construed to prohibit any grantee
under this part from expending the grant for the
purpose of providing counseling services described in this section to an individual who does
not undergo testing for HIV/AIDS as a result of
the grantee or the individual determining that
such testing of the individual is not appropriate.
(July 1, 1944, ch. 373, title XXVI, § 2662, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 610; amended Pub. L. 106–345, title III, § 321,
Oct. 20, 2000, 114 Stat. 1346; Pub. L. 109–415, title
III, § 305, title VII, § 703, Dec. 19, 2006, 120 Stat.
2807, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30,
2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 305, reenacted heading without
change and amended text generally, substituting provisions relating to counseling of individuals after testing
for HIV/AIDS, appropriateness of conditions, counseling of emergency response employees, and counseling
without testing, for provisions relating to counseling of
individuals before and after testing, appropriateness of
conditions, counseling of emergency response employees, and counseling without testing.
2000—Subsec. (c)(3). Pub. L. 106–345, § 321(1), in introductory provisions struck out ‘‘on’’ after ‘‘counseling’’.
Subsec. (c)(3)(A), (B). Pub. L. 106–345, § 321(2), inserted
‘‘on’’ before ‘‘the availability’’.
Subsec. (c)(3)(C). Pub. L. 106–345, § 321(3), designated
existing provisions as cl. (i), inserted ‘‘that explains’’
before ‘‘the benefits’’, and added cl. (ii).
Subsec. (c)(3)(D). Pub. L. 106–345, § 321(2), inserted
‘‘on’’ before ‘‘the availability’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–63. Applicability of requirements regarding confidentiality, informed consent, and
counseling
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, with respect to testing for HIV/
AIDS, any such testing carried out by the applicant with funds appropriated through this chapter will be carried out in accordance with conditions described in sections 300ff–61 and 300ff–62 of
this title.
(July 1, 1944, ch. 373, title XXVI, § 2663, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 611; amended Pub. L. 109–415, title III,
§ 306(a), title VII, §§ 702(3), 703, Dec. 19, 2006, 120
Stat. 2809, 2820; Pub. L. 111–87, § 2(a)(1), (3)(A),
Oct. 30, 2009, 123 Stat. 2885.)

§ 300ff–64

AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’.
Pub. L. 109–415, § 306(a), substituted ‘‘with funds appropriated through this chapter will be carried’’ for
‘‘will, without regard to whether such testing is carried
out with Federal funds, be carried’’.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–64. Additional required agreements
(a) Reports to Secretary
The Secretary may not make a grant under
this part unless—
(1) the applicant submits to the Secretary—
(A) a specification of the expenditures
made by the applicant for early intervention
services for the fiscal year preceding the fiscal year for which the applicant is applying
to receive the grant;
(B) an estimate of the number of individuals to whom the applicant has provided
such services for such fiscal year;
(C) information regarding how the expected expenditures of the grant are related
to the planning process for localities funded
under part A (including the planning process
described in section 300ff–12 of this title) and
for States funded under part B (including the
planning process described in section
300ff–27(b) of this title); and
(D) a specification of the expected expenditures and how those expenditures will improve overall client outcomes, as described
in the State plan under section 300ff–27(b) of
this title;
(2) the applicant agrees to submit to the
Secretary a report providing—
(A) the number of individuals to whom the
applicant provides early intervention services pursuant to the grant;
(B) epidemiological and demographic data
on the population of such individuals;
(C) the extent to which the costs of HIVrelated health care for such individuals are
paid by third-party payors;
(D) the average costs of providing each
category of early intervention service; and
(E) the aggregate amounts expended for
each such category;
(3) the applicant agrees to provide additional
documentation to the Secretary regarding the
process used to obtain community input into
the design and implementation of activities
related to such grant; and
(4) the applicant agrees to submit, every 2
years, to the lead State agency under section

§ 300ff–64

TITLE 42—THE PUBLIC HEALTH AND WELFARE

300ff–27(b)(4) of this title audits, consistent
with Office of Management and Budget circular A133, regarding funds expended in accordance with this subchapter and shall include necessary client level data to complete
unmet need calculations and Statewide coordinated statements of need process.
(b) Provision of opportunities for anonymous
counseling and testing
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, to the extent permitted under State
law, regulation or rule, the applicant will offer
substantial opportunities for an individual—
(1) to undergo counseling and testing regarding HIV/AIDS without being required to provide any information relating to the identity
of the individual; and
(2) to undergo such counseling and testing
through the use of a pseudonym.
(c) Prohibition against requiring testing as condition of receiving other health services
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, with respect to an individual seeking health services from the applicant, the applicant will not require the individual to undergo testing for HIV as a condition of receiving
any health services unless such testing is medically indicated in the provision of the health
services sought by the individual.
(d) Maintenance of support
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees to maintain the expenditures of the applicant for early intervention services at a level
equal to not less than the level of such expenditures maintained by the State for the fiscal year
preceding the fiscal year for which the applicant
is applying to receive the grant.
(e) Requirements regarding imposition of
charges for services
(1) In general
The Secretary may not make a grant under
this part unless, subject to paragraph (5), the
applicant for the grant agrees that—
(A) in the case of individuals with an income less than or equal to 100 percent of the
official poverty line, the applicant will not
impose a charge on any such individual for
the provision of early intervention services
under the grant;
(B) in the case of individuals with an income greater than 100 percent of the official
poverty line, the applicant—
(i) will impose a charge on each such individual for the provision of such services;
and
(ii) will impose the charge according to a
schedule of charges that is made available
to the public.
(2) Limitation on charges regarding individuals subject to charges
With respect to the imposition of a charge
for purposes of paragraph (1)(B)(ii), the Secretary may not make a grant under this part
unless, subject to paragraph (5), the applicant
for the grant agrees that—

Page 1264

(A) in the case of individuals with an income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the applicant will not, for
any calendar year, impose charges in an
amount exceeding 5 percent of the annual
gross income of the individual involved;
(B) in the case of individuals with an income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the applicant will not, for
any calendar year, impose charges in an
amount exceeding 7 percent of the annual
gross income of the individual involved; and
(C) in the case of individuals with an income greater than 300 percent of the official
poverty line, the applicant will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income of the individual involved.
(3) Assessment of charge
With respect to compliance with the agreement made under paragraph (1), a grantee
under this part may, in the case of individuals
subject to a charge for purposes of such paragraph—
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules and of
paragraph (2) regarding limitations on the
maximum amount of charges; and
(B) take into consideration the medical expenses of individuals in assessing the
amount of the charge, subject to such provisions.
(4) Applicability of limitation on amount of
charge
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that the limitations established in
paragraph (2) regarding the imposition of
charges for services applies to the annual aggregate of charges imposed for such services,
without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance,
or similar charges.
(5) Waiver regarding certain secondary agreements
The requirement established in paragraph
(1)(B)(i) shall be waived by the Secretary in
the case of any entity for whom the Secretary
has
granted
a
waiver
under
section
300ff–52(b)(2) of this title.
(f) Relationship to items and services under
other programs
(1) In general
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that, subject to paragraph (2), the grant
will not be expended by the applicant, or by
any entity receiving amounts from the applicant for the provision of early intervention
services, to make payment for any such service to the extent that payment has been made,
or can reasonably be expected to be made,
with respect to such service—

Page 1265

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) under any State compensation program, under an insurance policy, or under
any Federal or State health benefits program (except for a program administered by
or providing the services of the Indian
Health Service); or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
An agreement made under paragraph (1)
shall not apply in the case of an entity
through which a grantee under this part provides early intervention services if the Secretary has provided a waiver under section
300ff–52(b)(2) of this title regarding the entity.
(g) Administration of grant
The Secretary may not make a grant under
this part unless the applicant for the grant
agrees that—
(1) the applicant will not expend amounts received pursuant to this part for any purpose
other than the purposes described in the subpart under which the grant involved is made;
(2) the applicant will establish such procedures for fiscal control and fund accounting as
may be necessary to ensure proper disbursement and accounting with respect to the
grant;
(3) the applicant will not expend more than
10 percent of the grant for administrative expenses with respect to the grant, including
planning and evaluation, except that the costs
of a clinical quality management program
under paragraph (5) may not be considered administrative expenses for purposes of such
limitation;
(4) the applicant will submit evidence that
the proposed program is consistent with the
statewide coordinated statement of need and
agree to participate in the ongoing revision of
such statement of need; and
(5) the applicant will provide for the establishment of a clinical quality management
program—
(A) to assess the extent to which medical
services funded under this subchapter that
are provided to patients are consistent with
the most recent Public Health Service guidelines for the treatment of HIV/AIDS and related opportunistic infections, and as applicable, to develop strategies for ensuring that
such services are consistent with the guidelines; and
(B) to ensure that improvements in the access to and quality of HIV health services
are addressed.
(July 1, 1944, ch. 373, title XXVI, § 2664, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 611; amended Pub. L. 104–146, § 3(d)(5), May
20, 1996, 110 Stat. 1358; Pub. L. 106–345, title III,
§§ 301(b)(3), 322, Oct. 20, 2000, 114 Stat. 1345, 1346;
Pub. L. 109–415, title III, §§ 301(b), 306(b), (c), title
VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2806, 2809,
2820; Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009,
123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on

§ 300ff–65

Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (a)(1)(C), (D). Pub. L. 109–415, § 306(b)(1), added
subpars. (C) and (D).
Subsec. (a)(3), (4). Pub. L. 109–415, § 306(b)(2), (3), added
pars. (3) and (4).
Subsec. (b)(1). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
Subsec. (f)(1)(A). Pub. L. 109–415, § 306(c), inserted
‘‘(except for a program administered by or providing
the services of the Indian Health Service)’’ before semicolon.
Subsec. (g)(3). Pub. L. 109–415, § 301(b)(1), amended par.
(3) generally. Prior to amendment, par. (3) read as follows: ‘‘the applicant will not expend more than 10 percent including planning and evaluation of the grant for
administrative expenses with respect to the grant;’’.
Subsec. (g)(5). Pub. L. 109–415, § 301(b)(2), inserted
‘‘clinical’’ before ‘‘quality management’’ in introductory provisions.
Subsec. (g)(5)(A). Pub. L. 109–415, § 702(3), substituted
‘‘HIV/AIDS’’ for ‘‘HIV disease’’.
2000—Subsecs.
(e)(5),
(f)(2).
Pub.
L.
106–345,
§ 301(b)(3)(A), (B), struck out ‘‘300ff–42(b) or’’ after ‘‘a
waiver under section’’.
Subsec. (g)(3). Pub. L. 106–345, § 322(1)(A), substituted
‘‘10 percent’’ for ‘‘7.5 percent’’.
Subsec. (g)(5). Pub. L. 106–345, § 322(1)(B), (2), (3), added
par. (5).
Subsec. (h). Pub. L. 106–345, § 301(b)(3)(C), struck out
heading and text of subsec. (h). Text read as follows: ‘‘A
State may not use amounts received under a grant
awarded under section 300ff–41 of this title to purchase
or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any
building or other facility, or to make cash payments to
intended recipients of services.’’
1996—Subsec. (g)(3). Pub. L. 104–146, § 3(d)(5)(B)(i), substituted ‘‘7.5 percent including planning and evaluation’’ for ‘‘5 percent’’.
Subsec. (g)(4). Pub. L. 104–146, § 3(d)(5)(A), (B)(ii), (C),
added par. (4).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.

§ 300ff–65. Requirement of submission of application containing certain agreements and assurances
The Secretary may not make a grant under
this part unless—
(1) an application for the grant is submitted
to the Secretary containing agreements and
assurances in accordance with this part and
containing the information specified in section 300ff–64(a)(1) of this title;
(2) with respect to such agreements, the application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form,
is made in such manner, and contains such
agreements, assurances, and information as

§ 300ff–66

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Secretary determines to be necessary to
carry out this part.
(July 1, 1944, ch. 373, title XXVI, § 2665, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 614; amended Pub. L. 109–415, title VII,
§ 703, Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

Page 1266

§ 300ff–67. Use of funds
Counseling programs carried out under this
part—
(1) shall not be designed to promote or encourage, directly, intravenous drug abuse or
sexual activity, homosexual or heterosexual;
(2) shall be designed to reduce exposure to
and transmission of HIV/AIDS by providing accurate information;
(3) shall provide information on the health
risks of promiscuous sexual activity and intravenous drug abuse; and
(4) shall provide information on the transmission and prevention of hepatitis A, B, and
C, including education about the availability
of hepatitis A and B vaccines and assisting patients in identifying vaccination sites.
(July 1, 1944, ch. 373, title XXVI, § 2667, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 614; amended Pub. L. 109–415, title VII,
§§ 701, 702(3), 703, Dec. 19, 2006, 120 Stat. 2819, 2820;
Pub. L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123
Stat. 2885.)
AMENDMENTS

§ 300ff–66. Provision by Secretary of supplies and
services in lieu of grant funds
(a) In general
Upon the request of a grantee under this part,
the Secretary may, subject to subsection (b) of
this section, provide supplies, equipment, and
services for the purpose of aiding the grantee in
providing early intervention services and, for
such purpose, may detail to the State any officer or employee of the Department of Health
and Human Services.
(b) Limitation
With respect to a request described in subsection (a) of this section, the Secretary shall
reduce the amount of payments under the grant
involved by an amount equal to the costs of detailing personnel and the fair market value of
any supplies, equipment, or services provided by
the Secretary. The Secretary shall, for the payment of expenses incurred in complying with
such request, expend the amounts withheld.
(July 1, 1944, ch. 373, title XXVI, § 2666, as added
Pub. L. 101–381, title III, § 301(a), Aug. 18, 1990, 104
Stat. 614; amended Pub. L. 109–415, title VII,
§ 703, Dec. 19, 2006, 120 Stat. 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat. 2885.)
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Par. (2). Pub. L. 109–415, § 702(3), substituted ‘‘HIV/
AIDS’’ for ‘‘HIV disease’’.
Par. (4). Pub. L. 109–415, § 701, added par. (4).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

PART D—WOMEN, INFANTS, CHILDREN, AND
YOUTH
CODIFICATION
Part D of title XXVI of the Public Health Service
Act, comprising this part, was originally added to act
July 1, 1944, ch. 373, by Pub. L. 101–381, title IV, § 401,
Aug. 18, 1990, 104 Stat. 617, and amended by Pub. L.
104–146, May 20, 1996, 110 Stat. 1346; Pub. L. 102–531, Oct.
27, 1992, 106 Stat. 3469; Pub. L. 106–345, Oct. 20, 2000, 114
Stat. 1319; Pub. L. 108–173, Dec. 8, 2003, 117 Stat. 2066.
Part D is shown herein, however, as having been added
by Pub. L. 109–415, title IV, § 401, Dec. 19, 2006, 120 Stat.
2810, without reference to those intervening amendments because of the extensive revision of part D by
Pub. L. 109–415.

§ 300ff–71. Grants for coordinated services and
access to research for women, infants, children, and youth
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to public and
nonprofit private entities (including a health facility operated by or pursuant to a contract
with the Indian Health Service) for the purpose

Page 1267

TITLE 42—THE PUBLIC HEALTH AND WELFARE

of providing family-centered care involving outpatient or ambulatory care (directly or through
contracts or memoranda of understanding) for
women, infants, children, and youth with HIV/
AIDS.
(b) Additional services for patients and families
Funds provided under grants awarded under
subsection (a) may be used for the following support services:
(1) Family-centered care including case
management.
(2) Referrals for additional services including—
(A) referrals for inpatient hospital services, treatment for substance abuse, and
mental health services; and
(B) referrals for other social and support
services, as appropriate.
(3) Additional services necessary to enable
the patient and the family to participate in
the program established by the applicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
(4) The provision of information and education on opportunities to participate in HIV/
AIDS-related clinical research.
(c) Coordination with other entities
A grant awarded under subsection (a) may be
made only if the applicant provides an agreement that includes the following:
(1) The applicant will coordinate activities
under the grant with other providers of health
care services under this chapter, and under
title V of the Social Security Act [42 U.S.C. 701
et seq.], including programs promoting the reduction and elimination of risk of HIV/AIDS
for youth.
(2) The applicant will participate in the
statewide coordinated statement of need under
part B (where it has been initiated by the public health agency responsible for administering grants under part B) and in revisions of
such statement.
(3) The applicant will every 2 years submit
to the lead State agency under section
300ff–27(b)(4) of this title audits regarding
funds expended in accordance with this subchapter and shall include necessary clientlevel data to complete unmet need calculations and Statewide coordinated statements of
need process.
(d) Administration; application
A grant may only be awarded to an entity
under subsection (a) if an application for the
grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances,
and information as the Secretary determines to
be necessary to carry out this section. Such application shall include the following:
(1) Information regarding how the expected
expenditures of the grant are related to the
planning process for localities funded under
part A (including the planning process outlined in section 300ff–12 of this title) and for
States funded under part B (including the
planning process outlined in section 300ff–27(b)
of this title).
(2) A specification of the expected expenditures and how those expenditures will improve

§ 300ff–71

overall patient outcomes, as outlined as part
of the State plan (under section 300ff–27(b) of
this title) or through additional outcome
measures.
(e) Annual review of programs; evaluations
(1) Review regarding access to and participation in programs
With respect to a grant under subsection (a)
for an entity for a fiscal year, the Secretary
shall, not later than 180 days after the end of
the fiscal year, provide for the conduct and
completion of a review of the operation during
the year of the program carried out under such
subsection by the entity. The purpose of such
review shall be the development of recommendations, as appropriate, for improvements
in the following:
(A) Procedures used by the entity to allocate opportunities and services under subsection (a) among patients of the entity who
are women, infants, children, or youth.
(B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
(2) Evaluations
The Secretary shall, directly or through
contracts with public and private entities,
provide for evaluations of programs carried
out pursuant to subsection (a).
(f) Administrative expenses
(1) Limitation
A grantee may not use more than 10 percent
of amounts received under a grant awarded
under this section for administrative expenses.
(2) Clinical quality management program
A grantee under this section shall implement a clinical quality management program
to assess the extent to which HIV health services provided to patients under the grant are
consistent with the most recent Public Health
Service guidelines for the treatment of HIV/
AIDS and related opportunistic infection, and
as applicable, to develop strategies for ensuring that such services are consistent with the
guidelines for improvement in the access to
and quality of HIV health services.
(g) Training and technical assistance
From the amounts appropriated under subsection (j) for a fiscal year, the Secretary may
use not more than 5 percent to provide, directly
or through contracts with public and private entities (which may include grantees under subsection (a)), training and technical assistance to
assist applicants and grantees under subsection
(a) in complying with the requirements of this
section.
(h) Definitions
In this section:
(1) Administrative expenses
The term ‘‘administrative expenses’’ means
funds that are to be used by grantees for grant
management and monitoring activities, including costs related to any staff or activity
unrelated to services or indirect costs.
(2) Indirect costs
The term ‘‘indirect costs’’ means costs included in a Federally negotiated indirect rate.

§ 300ff–71

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Services
The term ‘‘services’’ means—
(A) services that are provided to clients to
meet the goals and objectives of the program
under this section, including the provision of
professional, diagnostic, and therapeutic
services by a primary care provider or a referral to and provision of specialty care; and
(B) services that sustain program activity
and contribute to or help improve services
under subparagraph (A).
(i) Application to primary care services
Nothing in this part shall be construed as requiring funds under this part to be used for primary care services when payments are available
for such services from other sources (including
under titles XVIII, XIX, and XXI of the Social
Security Act [42 U.S.C. 1395 et seq., 1396 et seq.,
1397aa et seq.]).
(j) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated,
$71,800,000 for each of the fiscal years 2007
through 2009, $75,390,000 for fiscal year 2010,
$79,160,000 for fiscal year 2011, $83,117,000 for fiscal year 2012, and $87,273,000 for fiscal year 2013.
(July 1, 1944, ch. 373, title XXVI, § 2671, as added
and amended Pub. L. 109–415, title IV, § 401, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2810, 2820; Pub.
L. 111–87, §§ 2(a)(1), (3)(A), (e), 11, Oct. 30, 2009, 123
Stat. 2885, 2886, 2895.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (c)(1)
and (i), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles
V, XVIII, XIX, and XXI of the Act are classified generally to subchapters V (§ 701 et seq.), XVIII (§ 1395 et
seq.), XIX (§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of
this title and Tables.
PRIOR PROVISIONS
Prior sections 300ff–71 to 300ff–78 were omitted in the
general amendment of this part by Pub. L. 109–415.
Section 300ff–71, act July 1, 1944, ch. 373, title XXVI,
§ 2671, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 617; amended Pub. L. 104–146, § 3(e), May
20, 1996, 110 Stat. 1358; Pub. L. 106–345, title IV, § 401,
Oct. 20, 2000, 114 Stat. 1347, related to grants for coordinated services and access to research for women, infants, children, and youth.
Section 300ff–72, act July 1, 1944, ch. 373, title XXVI,
§ 2672, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 618, contained provisions relating to
blood banks.
Section 300ff–73, act July 1, 1944, ch. 373, title XXVI,
§ 2673, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 619; amended Pub. L. 106–345, title V,
§ 503(a)(2), Oct. 20, 2000, 114 Stat. 1354, related to a research, evaluation, and assessment program.
Section 300ff–74, act July 1, 1944, ch. 373, title XXVI,
§ 2674, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 620; amended Pub. L. 104–146, § 3(f), May
20, 1996, 110 Stat. 1362; Pub. L. 106–345, title IV, § 411,
Oct. 20, 2000, 114 Stat. 1350, related to evaluations and
reports.
Section 300ff–75, act July 1, 1944, ch. 373, title XXVI,
§ 2675, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 620; amended Pub. L. 102–531, title III,
§ 312(d)(34), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 106–345,
title IV, §§ 413, 414, Oct. 20, 2000, 114 Stat. 1350, 1351; Pub.
L. 108–173, title IX, § 900(e)(2)(G), Dec. 8, 2003, 117 Stat.

Page 1268

2372, related to coordination of Federal HIV programs.
See section 300ff–81 of this title.
Section 300ff–75a, act July 1, 1944, ch. 373, title XXVI,
§ 2675A, as added Pub. L. 106–345, title IV, § 415, Oct. 20,
2000, 114 Stat. 1351, related to audits. See section
300ff–82 of this title.
Section 300ff–75b, act July 1, 1944, ch. 373, title XXVI,
§ 2675B, as added Pub. L. 106–345, title IV, § 416, Oct. 20,
2000, 114 Stat. 1351, related to administrative simplification.
Section 300ff–76, act July 1, 1944, ch. 373, title XXVI,
§ 2676, as added Pub. L. 101–381, title IV, § 401, Aug. 18,
1990, 104 Stat. 620; amended Pub. L. 104–146, § 12(a),
(c)(8), May 20, 1996, 110 Stat. 1373, 1374, defined terms for
this subchapter. See section 300ff–88 of this title.
Section 300ff–77, act July 1, 1944, ch. 373, title XXVI,
§ 2677, as added Pub. L. 104–146, § 6(a), May 20, 1996, 110
Stat. 1367; amended Pub. L. 106–345, title IV, § 417, Oct.
20, 2000, 114 Stat. 1352, authorized appropriations.
Section 300ff–78, act July 1, 1944, ch. 373, title XXVI,
§ 2678, as added Pub. L. 104–146, § 10, May 20, 1996, 110
Stat. 1373, prohibited promotion of certain activities.
See section 300ff–84 of this title.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a). Pub. L. 111–87, § 11(b), substituted ‘‘(directly or through contracts or memoranda of understanding)’’ for ‘‘(directly or through contracts)’’.
Subsec. (g). Pub. L. 111–87, § 11(a)(2), substituted ‘‘subsection (j)’’ for ‘‘subsection (i)’’.
Subsec. (i). Pub. L. 111–87, § 11(a)(3), added subsec. (i).
Former subsec. (i) redesignated (j).
Pub. L. 111–87, § 2(e), inserted ‘‘, $75,390,000 for fiscal
year 2010, $79,160,000 for fiscal year 2011, $83,117,000 for
fiscal year 2012, and $87,273,000 for fiscal year 2013’’ before period at end.
Subsec. (j). Pub. L. 111–87, § 11(a)(1), redesignated subsec. (i) as (j).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by sections 2(e) and 11 of Pub. L. 111–87 be applicable to
this section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.

PART E—GENERAL PROVISIONS
CODIFICATION
Part E of title XXVI of the Public Health Service
Act, comprising this part, was originally added to act
July 1, 1944, ch. 373, by Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 622, and amended by Pub. L.
104–146, May 20, 1996, 110 Stat. 1346. Part E is shown
herein, however, as having been added by Pub. L.
109–415, title IV, § 501, Dec. 19, 2006, 120 Stat. 2812, without reference to the intervening amendments because
of the extensive revision of part E by Pub. L. 109–415.
PRIOR PROVISIONS
A prior section 300ff–80, act July 1, 1944, ch. 373, title
XXVI, § 2680, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 622, related to grants for implementation of recommendations in guidelines and model
curriculum.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300ff–81. Coordination
(a) Requirement
The Secretary shall ensure that the Health
Resources and Services Administration, the
Centers for Disease Control and Prevention, the
Substance Abuse and Mental Health Services
Administration, and the Centers for Medicare &
Medicaid Services coordinate the planning,
funding, and implementation of Federal HIV
programs (including all minority AIDS initiatives of the Public Health Service, including
under section 300ff–121 of this title) to enhance
the continuity of care and prevention services
for individuals with HIV/AIDS or those at risk of
such disease. The Secretary shall consult with
other Federal agencies, including the Department of Veterans Affairs, as needed and utilize
planning information submitted to such agencies by the States and entities eligible for assistance under this subchapter.
(b) Report
The Secretary shall biennially prepare and
submit to the appropriate committees of the
Congress a report concerning the coordination
efforts at the Federal, State, and local levels described in this section, including a description of
Federal barriers to HIV program integration and
a strategy for eliminating such barriers and enhancing the continuity of care and prevention
services for individuals with HIV/AIDS or those
at risk of such disease.
(c) Integration by State
As a condition of receipt of funds under this
subchapter, a State shall provide assurances to
the Secretary that health support services funded under this subchapter will be integrated with
other such services, that programs will be coordinated with other available programs (including Medicaid), and that the continuity of care
and prevention services of individuals with HIV/
AIDS is enhanced.
(d) Integration by local or private entities
As a condition of receipt of funds under this
subchapter, a local government or private nonprofit entity shall provide assurances to the
Secretary that services funded under this subchapter will be integrated with other such services, that programs will be coordinated with
other available programs (including Medicaid),
and that the continuity of care and prevention
services of individuals with HIV is enhanced.
(July 1, 1944, ch. 373, title XXVI, § 2681, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2812, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
PRIOR PROVISIONS
A prior section 300ff–81, act July 1, 1944, ch. 373, title
XXVI, § 2681, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 623, related to development and
dissemination of list of infectious diseases, prior to the
general amendment of this part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.

§ 300ff–83

2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–82. Audits
(a) In general
For fiscal year 2009, and each subsequent fiscal
year, the Secretary may reduce the amounts of
grants under this subchapter to a State or political subdivision of a State for a fiscal year if,
with respect to such grants for the second preceding fiscal year, the State or subdivision fails
to prepare audits in accordance with the procedures of section 7502 of title 31. The Secretary
shall annually select representative samples of
such audits, prepare summaries of the selected
audits, and submit the summaries to the Congress.
(b) Posting on the Internet
All audits that the Secretary receives from
the State lead agency under section 300ff–27(b)(4)
of this title shall be posted, in their entirety, on
the Internet website of the Health Resources
and Services Administration.
(July 1, 1944, ch. 373, title XXVI, § 2682, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2813, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
PRIOR PROVISIONS
A prior section 300ff–82, July 1, 1944, ch. 373, title
XXVI, § 2682, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 623, related to routine notifications with respect to airborne infectious diseases in
victims assisted, prior to the general amendment of
this part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–83. Public health emergency
(a) In general
In an emergency area and during an emergency period, the Secretary shall have the authority to waive such requirements of this subchapter to improve the health and safety of

§ 300ff–84

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1270

those receiving care under this subchapter and
the general public, except that the Secretary
may not expend more than 5 percent of the funds
allocated under this subchapter for sections
300ff–29a of this title and section 1 300ff–13(b) of
this title.
(b) Emergency area and emergency period
In this section:
(1) Emergency area
The term ‘‘emergency area’’ means a geographic area in which there exists—
(A) an emergency or disaster declared by
the President pursuant to the National
Emergencies Act [50 U.S.C. 1601 et seq.] or
the Robert T. Stafford Disaster Relief and
Emergency Assistance Act [42 U.S.C. 5121 et
seq.]; or
(B) a public health emergency declared by
the Secretary pursuant to section 247d of
this title.
(2) Emergency period
The term ‘‘emergency period’’ means the period in which there exists—
(A) an emergency or disaster declared by
the President pursuant to the National
Emergencies Act or the Robert T. Stafford
Disaster Relief and Emergency Assistance
Act; or
(B) a public health emergency declared by
the Secretary pursuant to section 247d of
this title.
(c) Unobligated funds
If funds under a grant under this section are
not expended for an emergency in the fiscal year
in which the emergency is declared, such funds
shall be returned to the Secretary for reallocation under sections 300ff–13(b) and 300ff–29a of
this title.

Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.

(July 1, 1944, ch. 373, title XXVI, § 2683, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2813, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)

2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept, 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.

REFERENCES IN TEXT
The National Emergencies Act, referred to in subsec.
(b)(1)(A), (2)(A), is Pub. L. 94–412, Sept. 14, 1976, 90 Stat.
1255, which is classified principally to chapter 34 (§ 1601
et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short
Title note set out under section 1601 of Title 50 and
Tables.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (b)(1)(A),
(2)(A), is Pub. L. 93–288, May 22, 1974, 88 Stat. 143, which
is classified principally to chapter 68 (§ 5121 et seq.) of
this title. For complete classification of this Act to the
Code, see Short Title note set out under section 5121 of
this title and Tables.
PRIOR PROVISIONS
A prior section 300ff–83, act July 1, 1944, ch. 373, title
XXVI, § 2683, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 624, related to request for notifications with respect to victims assisted, prior to the
general amendment of this part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
1 So in original. The word ‘‘section’’ probably should not appear.

EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–84. Prohibition on promotion of certain
activities
None of the funds appropriated under this subchapter shall be used to fund AIDS programs, or
to develop materials, designed to promote or encourage, directly, intravenous drug use or sexual activity, whether homosexual or heterosexual. Funds authorized under this subchapter
may be used to provide medical treatment and
support services for individuals with HIV.
(July 1, 1944, ch. 373, title XXVI, § 2684, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2814, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
PRIOR PROVISIONS
A prior section 300ff–84, act July 1, 1944, ch. 373, title
XXVI, § 2684, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 626; amended Pub. L. 104–146,
§ 12(c)(10), May 20, 1996, 110 Stat. 1374, related to procedures for notification of exposure, prior to the general
amendment of this part by Pub. L. 109–415.
AMENDMENTS

EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–85. Privacy protections
(a) In general
The Secretary shall ensure that any information submitted to, or collected by, the Secretary
under this subchapter excludes any personally
identifiable information.
(b) Definition
In this section, the term ‘‘personally identifiable information’’ has the meaning given such
term under the regulations promulgated under
section 264(c) of the Health Insurance Portability and Accountability Act of 1996.
(July 1, 1944, ch. 373, title XXVI, § 2685, as added
and amended Pub. L. 109–415, title V, § 501, title

Page 1271

TITLE 42—THE PUBLIC HEALTH AND WELFARE

VII, § 703, Dec. 19, 2006, 120 Stat. 2814, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (b), is
section 264(c) of Pub. L. 104–191, which is set out as a
note under section 1320d–2 of this title.
PRIOR PROVISIONS
A prior section 300ff–85, act July 1, 1944, ch. 373, title
XXVI, § 2685, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 626, related to notification of
emergency response employees, prior to the general
amendment of this part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–86. GAO report
The Comptroller General of the Government
Accountability Office shall, not less than 1 year
after October 30, 2009, submit to the appropriate
committees of Congress a report describing Minority AIDS Initiative activities across the Department of Health and Human Services, including programs under this subchapter and programs at the Centers for Disease Control and
Prevention, the Substance Abuse and Mental
Health Services Administration, and other departmental agencies. Such report shall include a
history of program activities within each relevant agency and a description of activities conducted, people served and types of grantees
funded, and shall collect and describe best practices in community outreach and capacitybuilding of community based organizations serving the communities that are disproportionately
affected by HIV/AIDS.
(July 1, 1944, ch. 373, title XXVI, § 2686, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2814, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), (g), Oct. 30, 2009, 123
Stat. 2885, 2887.)
PRIOR PROVISIONS
A prior section 300ff–86, act July 1, 1944, ch. 373, title
XXVI, § 2686, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 627, related to selection of designated officers, prior to the general amendment of this
part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87, § 2(g), amended section generally.
Prior to amendment, text read as follows: ‘‘The Comptroller General of the Government Accountability Office shall biennially submit to the appropriate commit-

§ 300ff–87

tees of Congress a report that includes a description of
Federal, State, and local barriers to HIV program integration, particularly for racial and ethnic minorities,
including activities carried out under subpart III of
part F, and recommendations for enhancing the continuity of care and the provision of prevention services
for individuals with HIV/AIDS or those at risk for such
disease. Such report shall include a demonstration of
the manner in which funds under this subpart are being
expended and to what extent the services provided with
such funds increase access to prevention and care services for individuals with HIV/AIDS and build stronger
community linkages to address HIV prevention and
care for racial and ethnic minority communities.’’
Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 2(g) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.

§ 300ff–87. Severity of need index
(a) Development of index
Not later than September 30, 2008, the Secretary shall develop and submit to the appropriate committees of Congress a severity of need
index in accordance with subsection (c).
(b) Definition of severity of need index
In this section, the term ‘‘severity of need
index’’ means the index of the relative needs of
individuals within a State or area, as identified
by a number of different factors, and is a factor
or set of factors that is multiplied by the number of living HIV/AIDS cases in a State or area,
providing different weights to those cases based
on needs. Such factors or set of factors may be
different for different components of the provisions under this subchapter.
(c) Requirements for Secretarial submission
When the Secretary submits to the appropriate committees of Congress the severity of
need index under subsection (a), the Secretary
shall provide the following:
(1) Methodology for and rationale behind developing the severity of need index, including
information related to the field testing of the
severity of need index.
(2) An independent contractor analysis of activities carried out under paragraph (1).
(3) Information regarding the process by
which the Secretary received community
input regarding the application and development of the severity of need index.
(d) Annual reports
If the Secretary fails to submit the severity of
need index under subsection (a) in either of fiscal years 2007 or 2008, the Secretary shall prepare and submit to the appropriate committees
of Congress a report for such fiscal year—

§ 300ff–87a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) that updates progress toward having client level data;
(2) that updates the progress toward having
a severity of need index, including information
related to the methodology and process for obtaining community input; and
(3) that, as applicable, states whether the
Secretary could develop a severity of need
index before fiscal year 2009.
(July 1, 1944, ch. 373, title XXVI, § 2687, as added
and amended Pub. L. 109–415, title V, § 501, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2814, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
PRIOR PROVISIONS
A prior section 300ff–87, act July 1, 1944, ch. 373, title
XXVI, § 2687, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 627, related to limitations with
respect to duties of medical facilities, prior to the general amendment of this part by Pub. L. 109–415.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–87a. National HIV/AIDS testing goal
(a) In general
Not later than January 1, 2010, the Secretary
shall establish a national HIV/AIDS testing goal
of 5,000,000 tests for HIV/AIDS annually through
federally-supported HIV/AIDS prevention, treatment, and care programs, including programs
under this subchapter and other programs administered by the Centers for Disease Control
and Prevention.
(b) Annual report
Not later than January 1, 2011, and annually
thereafter, the Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall submit to Congress a report
describing, with regard to the preceding 12month reporting period—
(1) whether the testing goal described in subsection (a) has been met;
(2) the total number of individuals tested
through federally-supported and other HIV/
AIDS prevention, treatment, and care programs in each State;
(3) the number of individuals who—
(A) prior to such 12-month period, were unaware of their HIV status; and
(B) through federally-supported and other
HIV/AIDS prevention, treatment, and care
programs, were diagnosed and referred into
treatment and care during such period;

Page 1272

(4) any barriers, including State laws and
regulations, that the Secretary determines to
be a barrier to meeting the testing goal described in subsection (a);
(5) the amount of funding the Secretary determines necessary to meet the annual testing
goal in the following 12 months and the
amount of Federal funding expended to meet
the testing goal in the prior 12-month period;
and
(6) the most cost-effective strategies for
identifying and diagnosing individuals who
were unaware of their HIV status, including
voluntary testing with pre-test counseling,
routine screening including opt-out testing,
partner counseling and referral services, and
mass media campaigns.
(c) Review of program effectiveness
Not later than 1 year after October 30, 2009,
the Secretary, in consultation with the Director
of the Centers for Disease Control and Prevention, shall submit a report to Congress based on
a comprehensive review of each of the programs
and activities conducted by the Centers for Disease Control and Prevention as part of the Domestic HIV/AIDS Prevention Activities, including the following:
(1) The amount of funding provided for each
program or activity.
(2) The primary purpose of each program or
activity.
(3) The annual goals for each program or activity.
(4) The relative effectiveness of each program or activity with relation to the other
programs and activities conducted by the Centers for Disease Control and Prevention, based
on the—
(A) number of previously undiagnosed individuals with HIV/AIDS made aware of their
status and referred into the appropriate
treatment;
(B) amount of funding provided for each
program or activity compared to the number
of undiagnosed individuals with HIV/AIDS
made aware of their status;
(C) program’s contribution to the National
HIV/AIDS testing goal; and
(D) progress made toward the goals described in paragraph (3).
(5) Recommendations if any to Congress on
ways to allocate funding for domestic HIV/
AIDS prevention activities and programs in
order to achieve the National HIV/AIDS testing goal.
(d) Coordination with other Federal activities
In pursuing the National HIV/AIDS testing
goal, the Secretary, where appropriate, shall
consider and coordinate with other national
strategies conducted by the Federal Government
to address HIV/AIDS.
(July 1, 1944, ch. 373, title XXVI, § 2688, as added
Pub. L. 111–87, § 12(2), Oct. 30, 2009, 123 Stat. 2896.)
PRIOR PROVISIONS
A prior section 2688 of act July 1, 1944, was renumbered section 2689 and is classified to section 300ff–88 of
this title.
Another prior section 2688 of act July 1, 1944, was
classified to section 300ff–88 of this title prior to the
general amendment of this part by Pub. L. 109–415.

Page 1273

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section effective as if enacted on Sept. 30, 2009, see
section 2(a)(3)(B) of Pub. L. 111–87, set out as an Effective Date of 2009 Amendment; Revival of Section note
under section 300ff–11 of this title.

§ 300ff–88. Definitions
For purposes of this subchapter:
(1) AIDS
The term ‘‘AIDS’’ means acquired immune
deficiency syndrome.
(2) Co-occurring conditions
The term ‘‘co-occurring conditions’’ means
one or more adverse health conditions in an
individual with HIV/AIDS, without regard to
whether the individual has AIDS and without
regard to whether the conditions arise from
HIV.
(3) Counseling
The term ‘‘counseling’’ means such counseling provided by an individual trained to provide such counseling.
(4) Family-centered care
The term ‘‘family-centered care’’ means the
system of services described in this subchapter
that is targeted specifically to the special
needs of infants, children, women and families.
Family-centered care shall be based on a partnership between parents, professionals, and
the community designed to ensure an integrated, coordinated, culturally sensitive, and
community-based continuum of care for children, women, and families with HIV/AIDS.
(5) Families with HIV/AIDS
The term ‘‘families with HIV/AIDS’’ means
families in which one or more members have
HIV/AIDS.
(6) HIV
The term ‘‘HIV’’ means infection with the
human immunodeficiency virus.
(7) HIV/AIDS
(A) In general
The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from
AIDS.
(B) Counting of cases
The term ‘‘living cases of HIV/AIDS’’, with
respect to the counting of cases in a geographic area during a period of time, means
the sum of—
(i) the number of living non-AIDS cases
of HIV in the area; and
(ii) the number of living cases of AIDS in
the area.
(C) Non-AIDS cases
The term ‘‘non-AIDS’’, with respect to a
case of HIV, means that the individual involved has HIV but does not have AIDS.
(8) Human immunodeficiency virus
The term ‘‘human immunodeficiency virus’’
means the etiologic agent for AIDS.
(9) Official poverty line
The term ‘‘official poverty line’’ means the
poverty line established by the Director of the

§ 300ff–88

Office of Management and Budget and revised
by the Secretary in accordance with section
9902(2) of this title.
(10) Person
The term ‘‘person’’ includes one or more individuals, governments (including the Federal
Government and the governments of the
States), governmental agencies, political subdivisions, labor unions, partnerships, associations, corporations, legal representatives, mutual companies, joint-stock companies, trusts,
unincorporated organizations, receivers, trustees, and trustees in cases under title 11.
(11) State
(A) In general
The term ‘‘State’’ means each of the 50
States, the District of Columbia, and each of
the territories.
(B) Territories
The term ‘‘territory’’ means each of American Samoa, Guam, the Commonwealth of
Puerto Rico, the Commonwealth of the
Northern Mariana Islands, the Virgin Islands, the Republic of the Marshall Islands,
the Federated States of Micronesia, and
Palau.
(12) Youth with HIV
The term ‘‘youth with HIV’’ means individuals who are 13 through 24 years old and who
have HIV/AIDS.
(July 1, 1944, ch. 373, title XXVI, § 2689, formerly
§ 2688, as added and amended Pub. L. 109–415,
title V, § 501, title VII, § 703, Dec. 19, 2006, 120
Stat. 2815, 2820; renumbered § 2689 and amended
Pub. L. 111–87, §§ 2(a)(1), (3)(A), 12(1), Oct. 30, 2009,
123 Stat. 2885, 2896.)
PRIOR PROVISIONS
A prior section 300ff–88, act July 1, 1944, ch. 373, title
XXVI, § 2688, as added Pub. L. 101–381, title IV, § 411(a),
Aug. 18, 1990, 104 Stat. 627, provided rules of construction for former subpart II of this part, prior to the general amendment of this part by Pub. L. 109–415.
Prior sections 300ff–89 and 300ff–90 were omitted in
the general amendment of this part by Pub. L. 109–415.
Section 300ff–89, act July 1, 1944, ch. 373, title XXVI,
§ 2689, as added Pub. L. 101–381, title IV, § 411(a), Aug. 18,
1990, 104 Stat. 628, related to injunctions regarding violations of former subpart II of this part.
Section 300ff–90, act July 1, 1944, ch. 373, title XXVI,
§ 2690, as added Pub. L. 101–381, title IV, § 411(a), Aug. 18,
1990, 104 Stat. 628, related to applicability of former
subpart II of this part.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.

§ 300ff–101

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART F—DEMONSTRATION AND TRAINING
SUBPART I—SPECIAL PROJECTS OF NATIONAL
SIGNIFICANCE

§ 300ff–101. Special projects of national significance
(a) In general
Of the amount appropriated under each of
parts A, B, C, and D for each fiscal year, the Secretary shall use the greater of $20,000,000 or an
amount equal to 3 percent of such amount appropriated under each such part, but not to exceed $25,000,000, to administer special projects of
national significance to—
(1) quickly respond to emerging needs of individuals receiving assistance under this subchapter; and
(2) to fund special programs to develop a
standard electronic client information data
system to improve the ability of grantees
under this subchapter to report client-level
data to the Secretary.
(b) Grants
The Secretary shall award grants under subsection (a) to entities eligible for funding under
parts A, B, C, and D based on—
(1) whether the funding will promote obtaining client level data as it relates to the creation of a severity of need index, including
funds to facilitate the purchase and enhance
the utilization of qualified health information
technology systems;
(2) demonstrated ability to create and maintain a qualified health information technology
system;
(3) the potential replicability of the proposed
activity in other similar localities or nationally;
(4) the demonstrated reliability of the proposed qualified health information technology
system across a variety of providers, geographic regions, and clients; and
(5) the demonstrated ability to maintain a
safe and secure qualified health information
system; or
(6) newly emerging needs of individuals receiving assistance under this subchapter.
(c) Coordination
The Secretary may not make a grant under
this section unless the applicant submits evidence that the proposed program is consistent
with the statewide coordinated statement of
need, and the applicant agrees to participate in
the ongoing revision process of such statement
of need.
(d) Privacy protection
The Secretary may not make a grant under
this section for the development of a qualified
health information technology system unless
the applicant provides assurances to the Secretary that the system will, at a minimum,
comply with the privacy regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.
(e) Replication
The Secretary shall make information concerning successful models or programs devel-

Page 1274

oped under this part available to grantees under
this subchapter for the purpose of coordination,
replication, and integration. To facilitate efforts
under this subsection, the Secretary may provide for peer-based technical assistance for
grantees funded under this part.
(July 1, 1944, ch. 373, title XXVI, § 2691, as added
Pub. L. 104–146, § 3(g)(1), May 20, 1996, 110 Stat.
1362; amended Pub. L. 109–415, title VI, § 601, title
VII, § 703, Dec. 19, 2006, 120 Stat. 2816, 2820; Pub.
L. 111–87, § 2(a)(1), (3)(A), Oct. 30, 2009, 123 Stat.
2885.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (d), is
section 264(c) of Pub. L. 104–191, which is set out as a
note under section 1320d–2 of this title.
AMENDMENTS
2009—Pub. L. 111–87 repealed Pub. L. 109–415, § 703, and
revived the provisions of this section as in effect on
Sept. 30, 2009. See 2006 Amendment note and Effective
Date of 2009 Amendment; Revival of Section note
below.
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 601, amended section generally.
Prior to amendment, section related to use of funds for
special projects of national significance.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, and that the provisions of this section as
in effect on Sept. 30, 2009, be revived, see section 2(a)(2),
(3)(A) of Pub. L. 111–87, set out as a note under section
300ff–11 of this title.
SUBPART II—AIDS EDUCATION AND TRAINING
CENTERS

§ 300ff–111. HIV/AIDS communities, schools, and
centers
(a) Schools; centers
(1) In general
The Secretary may make grants and enter
into contracts to assist public and nonprofit
private entities and schools and academic
health science centers in meeting the costs of
projects—
(A) to train health personnel, including
practitioners in programs under this subchapter and other community providers, in
the diagnosis, treatment, and prevention of
HIV/AIDS, including the prevention of the
perinatal transmission of the disease, including measures for the prevention and
treatment of opportunistic infections, and
including (as applicable to the type of health
professional involved), prenatal and other
gynecological care for women with HIV/
AIDS;
(B) to train the faculty of schools of, and
graduate departments or programs of, medicine, nursing, osteopathic medicine, dentistry, public health, allied health, and mental health practice to teach health professions students to provide for the health care
needs of individuals with HIV/AIDS;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) to develop and disseminate curricula
and resource materials relating to the care
and treatment of individuals with such disease and the prevention of the disease
among individuals who are at risk of contracting the disease; and
(D) to develop protocols for the medical
care of women with HIV/AIDS, including
prenatal and other gynecological care for
such women.
(2) Preference in making grants
In making grants under paragraph (1), the
Secretary shall give preference to qualified
projects which will—
(A) train, or result in the training of,
health professionals who will provide treatment for minority individuals and Native
Americans with HIV/AIDS and other individuals who are at high risk of contracting such
disease;
(B) train, or result in the training of, minority health professionals and minority allied health professionals to provide treatment for individuals with such disease; and
(C) train or result in the training of health
professionals and allied health professionals
to provide treatment for hepatitis B or C coinfected individuals.
(3) Application
No grant or contract may be made under
paragraph (1) unless an application is submitted to the Secretary in such form, at such
time, and containing such information, as the
Secretary may prescribe.
(b) Dental schools
(1) In general
(A) Grants
The Secretary may make grants to dental
schools and programs described in subparagraph (B) to assist such schools and programs with respect to oral health care to patients with HIV/AIDS.
(B) Eligible applicants
For purposes of this subsection, the dental
schools and programs referred to in this subparagraph are dental schools and programs
that were described in section 294o(b)(4)(B) of
this title as such section was in effect on the
day before November 13, 1998, and in addition
dental hygiene programs that are accredited
by the Commission on Dental Accreditation.
(2) Application
Each dental school or program described in
section 1 the section referred to in paragraph
(1)(B) may annually submit an application
documenting the unreimbursed costs of oral
health care provided to patients with HIV/
AIDS by that school or hospital during the
prior year.
(3) Distribution
The Secretary shall distribute the available
funds among all eligible applicants, taking
into account the number of patients with HIV/
AIDS served and the unreimbursed oral health
1 So

in original.

§ 300ff–111

care costs incurred by each institution as
compared with the total number of patients
served and costs incurred by all eligible applicants.
(4) Maintenance of effort
The Secretary shall not make a grant under
this subsection if doing so would result in any
reduction in State funding allotted for such
purposes.
(5) Community-based care
The Secretary may make grants to dental
schools and programs described in paragraph
(1)(B) that partner with community-based dentists to provide oral health care to patients
with HIV/AIDS in unserved areas. Such partnerships shall permit the training of dental
students and residents and the participation of
community dentists as adjunct faculty.
(c) Authorization of appropriations
(1) Schools; centers
For the purpose of awarding grants under
subsection (a), there are authorized to be appropriated $34,700,000 for each of the fiscal
years 2007 through 2009, $36,535,000 for fiscal
year 2010, $38,257,000 for fiscal year 2011,
$40,170,000 for fiscal year 2012, and $42,178,000
for fiscal year 2013.
(2) Dental schools
For the purpose of awarding grants under
subsection (b), there are authorized to be appropriated $13,000,000 for each of the fiscal
years 2007 through 2009, $13,650,000 for fiscal
year 2010, $14,333,000 for fiscal year 2011,
$15,049,000 for fiscal year 2012, and $15,802,000
for fiscal year 2013.
(July 1, 1944, ch. 373, title XXVI, § 2692, formerly
title VII, § 776, as added Pub. L. 102–408, title I,
§ 102, Oct. 13, 1992, 106 Stat. 2050; amended Pub.
L. 102–531, title III, § 313(a)(4), Oct. 27, 1992, 106
Stat. 3507; renumbered title XXVI, § 2692, and
amended Pub. L. 104–146, § 3(h), May 20, 1996, 110
Stat. 1363; Pub. L. 104–166, § 5(2), July 29, 1996, 110
Stat. 1449; Pub. L. 106–345, title IV, § 402(a)(1), (b),
(c), Oct. 20, 2000, 114 Stat. 1348, 1349; Pub. L.
109–415, title VI, § 602, title VII, §§ 702(3), 703, Dec.
19, 2006, 120 Stat. 2817, 2820; Pub. L. 111–87,
§ 2(a)(1), (3)(A), (f)(1), Oct. 30, 2009, 123 Stat. 2885,
2886.)
CODIFICATION
Section was formerly classified to section 294n of this
title prior to renumbering by Pub. L. 104–146.
AMENDMENTS
2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (c)(1). Pub. L. 111–87, § 2(f)(1)(A), substituted
‘‘are authorized’’ for ‘‘is authorized’’ and inserted
‘‘, $36,535,000 for fiscal year 2010, $38,257,000 for fiscal
year 2011, $40,170,000 for fiscal year 2012, and $42,178,000
for fiscal year 2013’’ before period at end.
Subsec. (c)(2). Pub. L. 111–87, § 2(f)(1)(B), substituted
‘‘are authorized’’ for ‘‘is authorized’’ and inserted
‘‘, $13,650,000 for fiscal year 2010, $14,333,000 for fiscal
year 2011, $15,049,000 for fiscal year 2012, and $15,802,000
for fiscal year 2013’’ before period at end.

§ 300ff–121

TITLE 42—THE PUBLIC HEALTH AND WELFARE

2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for
‘‘HIV disease’’ wherever appearing in text.
Subsec. (a)(2)(A). Pub. L. 109–415, § 602(a)(1)(A), inserted ‘‘and Native Americans’’ after ‘‘minority individuals’’.
Subsec. (a)(2)(C). Pub. L. 109–415, § 602(a)(1)(B), (2), (3),
added subpar. (C).
Subsec. (c). Pub. L. 109–415, § 602(b), reenacted heading
without change and amended text generally, substituting provisions authorizing appropriations for fiscal
years 2007 through 2009 for provisions authorizing appropriations for fiscal years 2001 through 2005.
2000—Subsec. (a)(1)(A). Pub. L. 106–345, § 402(a)(1)(A),
substituted ‘‘to train’’ for ‘‘training’’, substituted
‘‘, including’’ for ‘‘and including’’ after ‘‘transmission
of the disease’’, and inserted ‘‘, and including (as applicable to the type of health professional involved), prenatal and other gynecological care for women with HIV
disease’’ before semicolon at end.
Subsec. (a)(1)(D). Pub. L. 106–345, § 402(a)(1)(B)–(D),
added subpar. (D).
Subsec. (b)(1). Pub. L. 106–345, § 402(b)(1), amended
heading and text of par. (1) generally. Prior to amendment, text read as follows: ‘‘The Secretary may make
grants to assist dental schools and programs described
in section 294o(b)(4)(B) of this title with respect to oral
health care to patients with HIV disease.’’
Subsec. (b)(2). Pub. L. 106–345, § 402(b)(2), substituted
‘‘the section referred to in paragraph (1)(B)’’ for
‘‘294o(b)(4)(B) of this title’’.
Subsec. (b)(5). Pub. L. 106–345, § 402(b)(3), added par.
(5).
Subsec. (c)(1). Pub. L. 106–345, § 402(c)(1), substituted
‘‘fiscal years 2001 through 2005’’ for ‘‘fiscal years 1996
through 2000’’.
Subsec. (c)(2). Pub. L. 106–345, § 402(c)(2), amended
heading and text of par. (2) generally. Prior to amendment, text read as follows: ‘‘For the purpose of grants
under subsection (b) of this section, there are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1996 through 2000.’’
1996—Pub. L. 104–146, § 3(h)(1), (2)(A), substituted
‘‘HIV/AIDS communities, schools, and centers’’ for
‘‘Acquired immune deficiency syndrome’’ as section
catchline.
Subsec. (a)(1)(A). Pub. L. 104–166, § 5(2)(A), substituted
‘‘in programs under this subchapter’’ for ‘‘in subchapter XXIV programs’’ and struck out ‘‘infection
and’’ after ‘‘prevention of HIV’’.
Pub. L. 104–146, § 3(h)(2)(B)(iii), added subpar. (A).
Former subpar. (A) redesignated (B).
Subsec. (a)(1)(B). Pub. L. 104–146, § 3(h)(2)(B)(iv), inserted ‘‘and’’ after semicolon.
Pub. L. 104–146, § 3(h)(2)(B)(i), (ii), redesignated subpar. (A) as (B) and struck out former subpar. (B) which
read as follows: ‘‘to train practitioners to provide for
the health care needs of such individuals;’’.
Subsec. (a)(1)(C), (D). Pub. L. 104–146, § 3(h)(2)(B)(i),
(ii), redesignated subpar. (D) as (C) and struck out
former subpar. (C) which read as follows: ‘‘with respect
to improving clinical skills in the diagnosis, treatment,
and prevention of such disease, to educate and train the
health professionals and clinical staff of schools of
medicine, osteopathic medicine, and dentistry; and’’.
Subsec. (c). Pub. L. 104–166, § 5(2)(B), added subsec. (c)
and struck out heading and text of former subsec. (c).
Text read as follows: ‘‘For purposes of this section:
‘‘(1) The term ‘HIV disease’ means infection with
the human immunodeficiency virus, and includes any
condition arising from such infection.
‘‘(2) The term ‘human immunodeficiency virus’
means the etiologic agent for acquired immune deficiency syndrome.’’
Subsec. (d). Pub. L. 104–166, § 5(2)(B), struck out heading and text of subsec. (d) relating to authorization of
appropriations for fiscal years 1996 through 2000. Text
read as follows: ‘‘There are authorized to be appro-

Page 1276

priated to carry out this section, such sums as may be
necessary for each of the fiscal years 1996 through
2000.’’
Pub. L. 104–166, § 5(2)(B), struck out heading and text
of subsec. (d) relating to authorization of appropriations for fiscal years 1993 through 1995. Text read as follows:
‘‘(1) SCHOOLS; CENTERS.—For the purpose of grants
under subsection (a) of this section, there is authorized
to be appropriated $23,000,000 for each of the fiscal years
1993 through 1995.
‘‘(2) DENTAL SCHOOLS.—For the purpose of grants
under subsection (b) of this section, there is authorized
to be appropriated $7,000,000 for each of the fiscal years
1993 through 1995.’’
Pub. L. 104–146, § 3(h)(4), added subsec. (d) relating to
authorization of appropriations for fiscal years 1996
through 2000.
1992—Subsec. (a)(3). Pub. L. 102–531, which directed
the substitution of ‘‘No grant’’ for ‘‘no grant’’ in par.
(3), could not be executed because the words ‘‘no grant’’
did not appear in par. (3).
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 2(f)(1) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–146 effective Oct. 1, 1996,
see section 13 of Pub. L. 104–146, set out as a note under
section 300ff–11 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–531 effective immediately
after enactment of Pub. L. 102–408, see section 313(c) of
Pub. L. 102–531, set out as a note under section 292y of
this title.
DISSEMINATION OF TREATMENT GUIDELINES; MEDICAL
CONSULTATION ACTIVITIES
Pub. L. 106–345, title IV, § 402(a)(2), Oct. 20, 2000, 114
Stat. 1349, provided that: ‘‘Not later than 90 days after
the date of the enactment of this Act [Oct. 20, 2000], the
Secretary of Health and Human Services shall issue
and begin implementation of a strategy for the dissemination of HIV treatment information to health
care providers and patients.’’
SUBPART III—MINORITY AIDS INITIATIVE

§ 300ff–121. Minority AIDS initiative
(a) In general
For the purpose of carrying out activities
under this section to evaluate and address the
disproportionate impact of HIV/AIDS on, and
the disparities in access, treatment, care, and
outcomes for, racial and ethnic minorities (including African Americans, Alaska Natives,
Latinos, American Indians, Asian Americans,
Native Hawaiians, and Pacific Islanders), there
are authorized to be appropriated $131,200,000 for
fiscal year 2007, $135,100,000 for fiscal year 2008,
$139,100,000 for fiscal year 2009, $146,055,000 for
fiscal year 2010, $153,358,000 for fiscal year 2011,
$161,026,000 for fiscal year 2012, and $169,077,000
for fiscal year 2013. The Secretary shall develop
a formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that
funding is provided based on the distribution of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

populations disproportionately impacted by
HIV/AIDS.
(b) Certain activities
(1) In general
In carrying out the purpose described in subsection (a), the Secretary shall provide for—
(A) emergency assistance under part A;
(B) care grants under part B;
(C) early intervention services under part
C;
(D) services through projects for HIV-related care under part D; and
(E) activities through education and training centers under section 300ff–111 of this
title.
(2) Allocations among activities
Activities under paragraph (1) shall be carried out by the Secretary in accordance with
the following:
(A) For supplemental grants to improve
HIV-related health outcomes to reduce existing racial and ethnic health disparities,
the Secretary shall, of the amount appropriated under subsection (a) for a fiscal year,
reserve the following, as applicable:
(i) For fiscal year 2007, $43,800,000.
(ii) For fiscal year 2008, $45,400,000.
(iii) For fiscal year 2009, $47,100,000.
(iv) For fiscal year 2010, $46,738,000.
(v) For fiscal year 2011, $49,075,000.
(vi) For fiscal year 2012, $51,528,000.
(vii) For fiscal year 2013, $54,105,000.
(B) For grants used for supplemental support education and outreach services to increase the number of eligible racial and ethnic minorities who have access to treatment
through the program under section 300ff–26
of this title for therapeutics, the Secretary
shall, of the amount appropriated for a fiscal
year under subsection (a), reserve the following, as applicable:
(i) For fiscal year 2007, $7,000,000.
(ii) For fiscal year 2008, $7,300,000.
(iii) For fiscal year 2009, $7,500,000.
(iv) For fiscal year 2010, $8,763,000.
(v) For fiscal year 2011, $9,202,000.
(vi) For fiscal year 2012, $9,662,000.
(vii) For fiscal year 2013, $10,145,000.
(C) For planning grants, capacity-building
grants, and services grants to health care
providers who have a history of providing
culturally and linguistically appropriate
care and services to racial and ethnic minorities, the Secretary shall, of the amount
appropriated for a fiscal year under subsection (a), reserve the following, as applicable:
(i) For fiscal year 2007, $53,400,000.
(ii) For fiscal year 2008, $55,400,000.
(iii) For fiscal year 2009, $57,400,000.
(iv) For fiscal year 2010, $61,343,000.
(v) For fiscal year 2011, $64,410,000.
(vi) For fiscal year 2012, $67,631,000.
(vii) For fiscal year 2013, $71,012,000.
(D) For eliminating racial and ethnic disparities in the delivery of comprehensive,
culturally and linguistically appropriate
care services for HIV/AIDS for women, in-

§ 300ff–121

fants, children, and youth, the Secretary
shall, of the amount appropriated under subsection (a), reserve the following, as applicable:
(i) For fiscal year 2010, $20,448,000.
(ii) For fiscal year 2011, $21,470,000.
(iii) For fiscal year 2012, $22,543,000.
(iv) For fiscal year 2013, $23,671,000.
(E) For increasing the training capacity of
centers to expand the number of health care
professionals with treatment expertise and
knowledge about the most appropriate
standards of HIV/AIDS-related treatments
and medical care for racial and ethnic minority adults, adolescents, and children with
HIV/AIDS, the Secretary shall, of the
amount appropriated under subsection (a),
reserve the following, as applicable:
(i) For fiscal year 2010, $8,763,000.
(ii) For fiscal year 2011, $9,201,000.
(iii) For fiscal year 2012, $9,662,000.
(iv) For fiscal year 2013, $10,144,000.
(c) Consistency with prior program
With respect to the purpose described in subsection (a), the Secretary shall carry out this
section consistent with the activities carried
out under this subchapter by the Secretary pursuant to the Departments of Labor, Health and
Human Services, and Education, and Related
Agencies Appropriations Act, 2002 (Public Law
107–116).
(d) Synchronization of minority AIDS initiative
For fiscal year 2010 and each subsequent fiscal
year, the Secretary shall incorporate and synchronize the schedule of application submissions
and funding availability under this section with
the schedule of application submissions and
funding availability under the corresponding
provisions of this subchapter as follows:
(1) The schedule for carrying out subsection
(b)(1)(A) shall be the same as the schedule applicable to emergency assistance under part A.
(2) The schedule for carrying out subsection
(b)(1)(B) shall be the same as the schedule applicable to care grants under part B.
(3) The schedule for carrying out subsection
(b)(1)(C) shall be the same as the schedule applicable to grants for early intervention services under part C.
(4) The schedule for carrying out subsection
(b)(1)(D) shall be the same as the schedule applicable to grants for services through projects
for HIV-related care under part D.
(5) The schedule for carrying out subsection
(b)(1)(E) shall be the same as the schedule applicable to grants and contracts for activities
through education and training centers under
section 300ff–111 of this title.
(July 1, 1944, ch. 373, title XXVI, § 2693, as added
and amended Pub. L. 109–415, title VI, § 603, title
VII, §§ 702(3), 703, Dec. 19, 2006, 120 Stat. 2818, 2820;
Pub. L. 111–87, § 2(a)(1), (3)(A), (f)(2), Oct. 30, 2009,
123 Stat. 2885, 2886.)
REFERENCES IN TEXT
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2002, referred to in subsec. (c), is Pub. L.
107–116, Jan. 10, 2002, 115 Stat. 2177. For complete classification of this Act to the Code, see Tables.

§ 300ff–131

TITLE 42—THE PUBLIC HEALTH AND WELFARE
AMENDMENTS

2009—Pub. L. 111–87, § 2(a)(1), (3)(A), repealed Pub. L.
109–415, § 703, and revived the provisions of this section
as in effect on Sept. 30, 2009. See 2006 Amendment note
and Effective Date of 2009 Amendment; Revival of Section note below.
Subsec. (a). Pub. L. 111–87, § 2(f)(2)(A), substituted
‘‘$139,100,000 for fiscal year 2009, $146,055,000 for fiscal
year 2010, $153,358,000 for fiscal year 2011, $161,026,000 for
fiscal year 2012, and $169,077,000 for fiscal year 2013. The
Secretary shall develop a formula for the awarding of
grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is provided based on the distribution
of populations disproportionately impacted by HIV/
AIDS.’’ for ‘‘and $139,100,000 for fiscal year 2009.’’
Subsec. (b)(2)(A). Pub. L. 111–87, § 2(f)(2)(B)(i), struck
out ‘‘competitive,’’ before ‘‘supplemental’’ in introductory provisions and added cls. (iv) to (vii).
Subsec. (b)(2)(B). Pub. L. 111–87, § 2(f)(2)(B)(ii), struck
out ‘‘competitive’’ before ‘‘grants’’ in introductory provisions and added cls. (iv) to (vii).
Subsec. (b)(2)(C)(iv) to (vii). Pub. L. 111–87,
§ 2(f)(2)(B)(iii), added cls. (iv) to (vii).
Subsec. (b)(2)(D). Pub. L. 111–87, § 2(f)(2)(B)(iv), substituted ‘‘the following, as applicable:’’ for ‘‘$18,500,000
for each of the fiscal years 2007 through 2009.’’ and
added cls. (i) to (iv).
Subsec. (b)(2)(E). Pub. L. 111–87, § 2(f)(2)(B)(v), substituted ‘‘the following, as applicable:’’ for ‘‘$8,500,000
for each of the fiscal years 2007 through 2009.’’ and
added cls. (i) to (iv).
Subsec. (d). Pub. L. 111–87, § 2(f)(2)(C), added subsec.
(d).
2006—Pub. L. 109–415, § 703, which directed repeal of
this section effective Oct. 1, 2009, was itself repealed by
Pub. L. 111–87, § 2(a)(1), effective Sept. 30, 2009.
Subsec. (b)(2)(D), (E). Pub. L. 109–415, § 702(3), substituted ‘‘HIV/AIDS’’ for ‘‘HIV disease’’ wherever appearing.
EFFECTIVE DATE OF 2009 AMENDMENT; REVIVAL OF
SECTION
For provisions that repeal by section 2(a)(1) of Pub.
L. 111–87 of section 703 of Pub. L. 109–415 be effective
Sept. 30, 2009, that the provisions of this section as in
effect on Sept. 30, 2009, be revived, and that amendment
by section 2(f)(2) of Pub. L. 111–87 be applicable to this
section as so revived and effective as if enacted on
Sept. 30, 2009, see section 2(a)(2), (3) of Pub. L. 111–87,
set out as a note under section 300ff–11 of this title.

PART G—NOTIFICATION OF POSSIBLE EXPOSURE
TO INFECTIOUS DISEASES
§ 300ff–131. Infectious diseases and circumstances relevant to notification requirements
(a) In general
Not later than 180 days after October 30, 2009,
the Secretary shall complete the development
of—
(1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which emergency response
employees may be exposed in responding to
emergencies;
(2) guidelines describing the circumstances
in which such employees may be exposed to
such diseases, taking into account the conditions under which emergency response is provided; and
(3) guidelines describing the manner in
which medical facilities should make determinations for purposes of section 300ff–133(d)
of this title.
(b) Specification of airborne infectious diseases
The list developed by the Secretary under subsection (a)(1) shall include a specification of

Page 1278

those infectious diseases on the list that are
routinely transmitted through airborne or aerosolized means.
(c) Dissemination
The Secretary shall—
(1) transmit to State public health officers
copies of the list and guidelines developed by
the Secretary under subsection (a) with the request that the officers disseminate such copies
as appropriate throughout the States; and
(2) make such copies available to the public.
(July 1, 1944, ch. 373, title XXVI, § 2695, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2897.)
EFFECTIVE DATE
Part effective as if enacted on Sept. 30, 2009, see section 2(a)(3)(B) of Pub. L. 111–87, set out as an Effective
Date of 2009 Amendment; Revival of Section note under
section 300ff–11 of this title.

§ 300ff–132. Routine notifications with respect to
airborne infectious diseases in victims assisted
(a) Routine notification of designated officer
(1) Determination by treating facility
If a victim of an emergency is transported
by emergency response employees to a medical
facility and the medical facility makes a determination that the victim has an airborne
infectious disease, the medical facility shall
notify the designated officer of the emergency
response employees who transported the victim to the medical facility of the determination.
(2) Determination by facility ascertaining
cause of death
If a victim of an emergency is transported
by emergency response employees to a medical
facility and the victim dies at or before reaching the medical facility, the medical facility
ascertaining the cause of death shall notify
the designated officer of the emergency response employees who transported the victim
to the initial medical facility of any determination by the medical facility that the victim had an airborne infectious disease.
(b) Requirement of prompt notification
With respect to a determination described in
paragraph (1) or (2) of subsection (a), the notification required in each of such paragraphs shall
be made as soon as is practicable, but not later
than 48 hours after the determination is made.
(July 1, 1944, ch. 373, title XXVI, § 2695A, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2898.)
§ 300ff–133. Request for notification with respect
to victims assisted
(a) Initiation of process by employee
If an emergency response employee believes
that the employee may have been exposed to an
infectious disease by a victim of an emergency
who was transported to a medical facility as a
result of the emergency, and if the employee attended, treated, assisted, or transported the victim pursuant to the emergency, then the designated officer of the employee shall, upon the
request of the employee, carry out the duties de-

Page 1279

TITLE 42—THE PUBLIC HEALTH AND WELFARE

scribed in subsection (b) regarding a determination of whether the employee may have been exposed to an infectious disease by the victim.
(b) Initial determination by designated officer
The duties referred to in subsection (a) are
that—
(1) the designated officer involved collect
the facts relating to the circumstances under
which, for purposes of subsection (a), the employee involved may have been exposed to an
infectious disease; and
(2) the designated officer evaluate such facts
and make a determination of whether, if the
victim involved had any infectious disease included on the list issued under paragraph (1) of
section 300ff–131(a) of this title, the employee
would have been exposed to the disease under
such facts, as indicated by the guidelines issued under paragraph (2) of such section.
(c) Submission of request to medical facility
(1) In general
If a designated officer makes a determination under subsection (b)(2) that an emergency
response employee may have been exposed to
an infectious disease, the designated officer
shall submit to the medical facility to which
the victim involved was transported a request
for a response under subsection (d) regarding
the victim of the emergency involved.
(2) Form of request
A request under paragraph (1) shall be in
writing and be signed by the designated officer
involved, and shall contain a statement of the
facts collected pursuant to subsection (b)(1).
(d) Evaluation and response regarding request to
medical facility
(1) In general
If a medical facility receives a request under
subsection (c), the medical facility shall
evaluate the facts submitted in the request
and make a determination of whether, on the
basis of the medical information possessed by
the facility regarding the victim involved, the
emergency response employee was exposed to
an infectious disease included on the list issued under paragraph (1) of section 300ff–131(a)
of this title, as indicated by the guidelines issued under paragraph (2) of such section.
(2) Notification of exposure
If a medical facility makes a determination
under paragraph (1) that the emergency response employee involved has been exposed to
an infectious disease, the medical facility
shall, in writing, notify the designated officer
who submitted the request under subsection
(c) of the determination.
(3) Finding of no exposure
If a medical facility makes a determination
under paragraph (1) that the emergency response employee involved has not been exposed to an infectious disease, the medical facility shall, in writing, inform the designated
officer who submitted the request under subsection (c) of the determination.
(4) Insufficient information
(A) If a medical facility finds in evaluating
facts for purposes of paragraph (1) that the

§ 300ff–133

facts are insufficient to make the determination described in such paragraph, the medical
facility shall, in writing, inform the designated officer who submitted the request
under subsection (c) of the insufficiency of the
facts.
(B)(i) If a medical facility finds in making a
determination under paragraph (1) that the facility possesses no information on whether the
victim involved has an infectious disease included on the list under section 300ff–131(a) of
this title, the medical facility shall, in writing, inform the designated officer who submitted the request under subsection (c) of the insufficiency of such medical information.
(ii) If after making a response under clause
(i) a medical facility determines that the victim involved has an infectious disease, the
medical facility shall make the determination
described in paragraph (1) and provide the applicable response specified in this subsection.
(e) Time for making response
After receiving a request under subsection (c)
(including any such request resubmitted under
subsection (g)(2)), a medical facility shall make
the applicable response specified in subsection
(d) as soon as is practicable, but not later than
48 hours after receiving the request.
(f) Death of victim of emergency
(1) Facility ascertaining cause of death
If a victim described in subsection (a) dies at
or before reaching the medical facility involved, and the medical facility receives a request under subsection (c), the medical facility shall provide a copy of the request to the
medical facility ascertaining the cause of
death of the victim, if such facility is a different medical facility than the facility that
received the original request.
(2) Responsibility of facility
Upon the receipt of a copy of a request for
purposes of paragraph (1), the duties otherwise
established in this part regarding medical facilities shall apply to the medical facility ascertaining the cause of death of the victim in
the same manner and to the same extent as
such duties apply to the medical facility originally receiving the request.
(g) Assistance of public health officer
(1) Evaluation of response of medical facility
regarding insufficient facts
(A) In the case of a request under subsection
(c) to which a medical facility has made the
response specified in subsection (d)(4)(A) regarding the insufficiency of facts, the public
health officer for the community in which the
medical facility is located shall evaluate the
request and the response, if the designated officer involved submits such documents to the
officer with the request that the officer make
such an evaluation.
(B) As soon as is practicable after a public
health officer receives a request under subparagraph (A), but not later than 48 hours
after receipt of the request, the public health
officer shall complete the evaluation required
in such paragraph and inform the designated
officer of the results of the evaluation.

§ 300ff–134

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Findings of evaluation
(A) If an evaluation under paragraph (1)(A)
indicates that the facts provided to the medical facility pursuant to subsection (c) were
sufficient for purposes of determinations
under subsection (d)(1)—
(i) the public health officer shall, on behalf
of the designated officer involved, resubmit
the request to the medical facility; and
(ii) the medical facility shall provide to
the designated officer the applicable response specified in subsection (d).
(B) If an evaluation under paragraph (1)(A)
indicates that the facts provided in the request to the medical facility were insufficient
for purposes of determinations specified in
subsection (c)—
(i) the public health officer shall provide
advice to the designated officer regarding
the collection and description of appropriate
facts; and
(ii) if sufficient facts are obtained by the
designated officer—
(I) the public health officer shall, on behalf of the designated officer involved, resubmit the request to the medical facility;
and
(II) the medical facility shall provide to
the designated officer the appropriate response under subsection (c).
(July 1, 1944, ch. 373, title XXVI, § 2695B, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2898.)
§ 300ff–134. Procedures for notification of exposure
(a) Contents of notification to officer
In making a notification required under section
300ff–132
of
this
title
or
section
300ff–133(d)(2) of this title, a medical facility
shall provide—
(1) the name of the infectious disease involved; and
(2) the date on which the victim of the emergency involved was transported by emergency
response employees to the medical facility involved.
(b) Manner of notification
If a notification under section 300ff–132 of this
title or section 300ff–133(d)(2) of this title is
mailed or otherwise indirectly made—
(1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer to whom the notification is sent of the fact that the notification has been sent; and
(2) such designated officer shall, not later
than 10 days after being informed by the medical facility that the notification has been
sent, inform such medical facility whether the
designated officer has received the notification.
(July 1, 1944, ch. 373, title XXVI, § 2695C, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2901.)
§ 300ff–135. Notification of employee
(a) In general
After receiving a notification for purposes of
section 300ff–132 or 300ff–133(d)(2) of this title, a

Page 1280

designated officer of emergency response employees shall, to the extent practicable, immediately notify each of such employees who—
(1) responded to the emergency involved; and
(2) as indicated by guidelines developed by
the Secretary, may have been exposed to an
infectious disease.
(b) Certain contents of notification to employee
A notification under this subsection to an
emergency response employee shall inform the
employee of—
(1) the fact that the employee may have
been exposed to an infectious disease and the
name of the disease involved;
(2) any action by the employee that, as indicated by guidelines developed by the Secretary, is medically appropriate; and
(3) if medically appropriate under such criteria, the date of such emergency.
(c) Responses other than notification of exposure
After receiving a response under paragraph (3)
or (4) of subsection (d) of section 300ff–133 of this
title, or a response under subsection (g)(1) of
such section, the designated officer for the employee shall, to the extent practicable, immediately inform the employee of the response.
(July 1, 1944, ch. 373, title XXVI, § 2695D, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2901.)
§ 300ff–136. Selection of designated officers
(a) In general
For the purposes of receiving notifications and
responses and making requests under this part
on behalf of emergency response employees, the
public health officer of each State shall designate 1 official or officer of each employer of
emergency response employees in the State.
(b) Preference in making designations
In making the designations required in subsection (a), a public health officer shall give
preference to individuals who are trained in the
provision of health care or in the control of infectious diseases.
(July 1, 1944, ch. 373, title XXVI, § 2695E, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2901.)
§ 300ff–137. Limitation with respect to duties of
medical facilities
The duties established in this part for a medical facility—
(1) shall apply only to medical information
possessed by the facility during the period in
which the facility is treating the victim for
conditions arising from the emergency, or during the 60-day period beginning on the date on
which the victim is transported by emergency
response employees to the facility, whichever
period expires first; and
(2) shall not apply to any extent after the expiration of the 30-day period beginning on the
expiration of the applicable period referred to
in paragraph (1), except that such duties shall
apply with respect to any request under section 300ff–133(c) of this title received by a medical facility before the expiration of such 30day period.
(July 1, 1944, ch. 373, title XXVI, § 2695F, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2901.)

Page 1281

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300ff–138. Miscellaneous provisions
(a) Liability of medical facilities, designated officers, public health officers, and governing
entities
This part may not be construed to authorize
any cause of action for damages or any civil
penalty against any medical facility, any designated officer, any other public health officer,
or any governing entity of such facility or officer for failure to comply with the duties established in this part.
(b) Testing
This part may not, with respect to victims of
emergencies, be construed to authorize or require a medical facility to test any such victim
for any infectious disease.
(c) Confidentiality
This part may not be construed to authorize
or require any medical facility, any designated
officer of emergency response employees, or any
such employee, to disclose identifying information with respect to a victim of an emergency or
with respect to an emergency response employee.
(d) Failure to provide emergency services
This part may not be construed to authorize
any emergency response employee to fail to respond, or to deny services, to any victim of an
emergency.
(e) Notification and reporting deadlines
In any case in which the Secretary determines
that, wholly or partially as a result of a public
health emergency that has been determined pursuant to section 247d(a) of this title, individuals
or public or private entities are unable to comply with the requirements of this part, the Secretary may, notwithstanding any other provision of law, temporarily suspend, in whole or in
part, the requirements of this part as the circumstances reasonably require. Before or
promptly after such a suspension, the Secretary
shall notify the Congress of such action and publish in the Federal Register a notice of the suspension.
(f) Continued application of State and local law
Nothing in this part shall be construed to
limit the application of State or local laws that
require the provision of data to public health
authorities.
(July 1, 1944, ch. 373, title XXVI, § 2695G, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2902.)
§ 300ff–139. Injunctions regarding violation of
prohibition
(a) In general
The Secretary may, in any court of competent
jurisdiction, commence a civil action for the
purpose of obtaining temporary or permanent
injunctive relief with respect to any violation of
this part.
(b) Facilitation of information on violations
The Secretary shall establish an administrative process for encouraging emergency response
employees to provide information to the Secretary regarding violations of this part. As ap-

§ 300gg

propriate, the Secretary shall investigate alleged such 1 violations and seek appropriate injunctive relief.
(July 1, 1944, ch. 373, title XXVI, § 2695H, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2902.)
§ 300ff–140. Applicability of part
This part shall not apply in a State if the chief
executive officer of the State certifies to the
Secretary that the law of the State is substantially consistent with this part.
(July 1, 1944, ch. 373, title XXVI, § 2695I, as added
Pub. L. 111–87, § 13, Oct. 30, 2009, 123 Stat. 2903.)
SUBCHAPTER
LATING TO
ERAGE

XXV—REQUIREMENTS
REHEALTH INSURANCE COVPRIOR PROVISIONS

A prior subchapter XXV (§ 300aaa et seq.), comprised
of title XXVII of the Public Health Service Act, act
July 1, 1944, ch. 373, §§ 2701 to 2714, was renumbered title
II, part B, §§ 231 to 244, of the Public Health Service
Act, and transferred to part B (§ 238 et seq.) of subchapter I of this chapter.
AMENDMENTS
1996—Pub. L. 104–204, title VI, § 604(a)(1), Sept. 26, 1996,
110 Stat. 2938, substituted ‘‘REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE’’ for ‘‘ASSURING PORTABILITY, AVAILABILITY, AND RENEWABILITY OF HEALTH INSURANCE COVERAGE’’
as subchapter heading.

PART A—INDIVIDUAL AND GROUP MARKET
REFORMS
AMENDMENTS
2010—Pub. L. 111–148, title I, § 1001(1), Mar. 23, 2010, 124
Stat. 130, substituted ‘‘Individual and Group Market
Reforms’’ for ‘‘Group Market Reforms’’ in part heading.
SUBPART 1—GENERAL REFORM

AMENDMENTS
2010—Pub. L. 111–148, title I, §§ 1201(1), 1255, formerly
§ 1253, title X, § 10103(e), (f)(1), Mar. 23, 2010, 124 Stat. 154,
162, 895, substituted ‘‘general reform’’ for ‘‘portability,
access, and renewability requirements’’ in subpart
heading, effective for plan years beginning on or after
Jan. 1, 2014.

§ 300gg. Fair health insurance premiums
(a) 1 Prohibiting discriminatory premium rates
(1) In general
With respect to the premium rate charged
by a health insurance issuer for health insurance coverage offered in the individual or
small group market—
(A) such rate shall vary with respect to the
particular plan or coverage involved only
by—
(i) whether such plan or coverage covers
an individual or family;
(ii) rating area, as established in accordance with paragraph (2);
(iii) age, except that such rate shall not
vary by more than 3 to 1 for adults (consistent with section 300gg–6(c) of this
title); and
1 So
1 So

in original.
in original. No subsec. (b) has been enacted.

§ 300gg

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iv) tobacco use, except that such rate
shall not vary by more than 1.5 to 1; and
(B) such rate shall not vary with respect to
the particular plan or coverage involved by
any other factor not described in subparagraph (A).
(2) Rating area
(A) In general
Each State shall establish 1 or more rating
areas within that State for purposes of applying the requirements of this subchapter.
(B) Secretarial review
The Secretary shall review the rating
areas established by each State under subparagraph (A) to ensure the adequacy of
such areas for purposes of carrying out the
requirements of this subchapter. If the Secretary determines a State’s rating areas are
not adequate, or that a State does not establish such areas, the Secretary may establish
rating areas for that State.
(3) Permissible age bands
The Secretary, in consultation with the National Association of Insurance Commissioners, shall define the permissible age bands
for rating purposes under paragraph (1)(A)(iii).
(4) Application of variations based on age or
tobacco use
With respect to family coverage under a
group health plan or health insurance coverage, the rating variations permitted under
clauses (iii) and (iv) of paragraph (1)(A) shall
be applied based on the portion of the premium that is attributable to each family
member covered under the plan or coverage.
(5) Special rule for large group market
If a State permits health insurance issuers
that offer coverage in the large group market
in the State to offer such coverage through
the State Exchange (as provided for under section 18032(f)(2)(B) of this title), the provisions
of this subsection shall apply to all coverage
offered in such market (other than self-insured
group health plans offered in such market) in
the State.
(July 1, 1944, ch. 373, title XXVII, § 2701, as added
and amended Pub. L. 111–148, title I, § 1201(4),
title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155, 892.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
PRIOR PROVISIONS
A prior section 300gg, act July 1, 1944, ch. 373, title
XXVII, § 2701, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1955; amended Pub. L. 111–3, title
III, § 311(b)(2), Feb. 4, 2009, 123 Stat. 70; Pub. L. 111–5,
div. B, title I, § 1899D(c), Feb. 17, 2009, 123 Stat. 426; Pub.
L. 111–344, title I, § 114(c), Dec. 29, 2010, 124 Stat. 3615,
was renumbered section 2704 of act July 1, 1944, effective for plan years beginning on or after Jan. 1, 2014,
with certain exceptions, and amended, by Pub. L.
111–148, title I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1),
title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911,
and was transferred to section 300gg–3 of this title.
Prior to amendment and transfer by Pub. L. 111–148,
text of section 300gg read as follows:

Page 1282

‘‘(a) LIMITATION ON PREEXISTING CONDITION EXCLUSION
PERIOD; CREDITING FOR PERIODS OF PREVIOUS COVERAGE.—Subject to subsection (d) of this section, a
group health plan, and a health insurance issuer offering group health insurance coverage, may, with respect
to a participant or beneficiary, impose a preexisting
condition exclusion only if—
‘‘(1) such exclusion relates to a condition (whether
physical or mental), regardless of the cause of the
condition, for which medical advice, diagnosis, care,
or treatment was recommended or received within
the 6-month period ending on the enrollment date;
‘‘(2) such exclusion extends for a period of not more
than 12 months (or 18 months in the case of a late enrollee) after the enrollment date; and
‘‘(3) the period of any such preexisting condition exclusion is reduced by the aggregate of the periods of
creditable coverage (if any, as defined in subsection
(c)(1) of this section) applicable to the participant or
beneficiary as of the enrollment date.
‘‘(b) DEFINITIONS.—For purposes of this part—
‘‘(1) PREEXISTING CONDITION EXCLUSION.—
‘‘(A) IN GENERAL.—The term ‘preexisting condition exclusion’ means, with respect to coverage, a
limitation or exclusion of benefits relating to a
condition based on the fact that the condition was
present before the date of enrollment for such coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before such date.
‘‘(B) TREATMENT OF GENETIC INFORMATION.—Genetic information shall not be treated as a condition described in subsection (a)(1) of this section in
the absence of a diagnosis of the condition related
to such information.
‘‘(2) ENROLLMENT DATE.—The term ‘enrollment
date’ means, with respect to an individual covered
under a group health plan or health insurance coverage, the date of enrollment of the individual in the
plan or coverage or, if earlier, the first day of the
waiting period for such enrollment.
‘‘(3) LATE ENROLLEE.—The term ‘late enrollee’
means, with respect to coverage under a group health
plan, a participant or beneficiary who enrolls under
the plan other than during—
‘‘(A) the first period in which the individual is eligible to enroll under the plan, or
‘‘(B) a special enrollment period under subsection
(f) of this section.
‘‘(4) WAITING PERIOD.—The term ‘waiting period’
means, with respect to a group health plan and an individual who is a potential participant or beneficiary
in the plan, the period that must pass with respect to
the individual before the individual is eligible to be
covered for benefits under the terms of the plan.
‘‘(c) RULES RELATING TO CREDITING PREVIOUS COVERAGE.—
‘‘(1) CREDITABLE COVERAGE DEFINED.—For purposes
of this subchapter, the term ‘creditable coverage’
means, with respect to an individual, coverage of the
individual under any of the following:
‘‘(A) A group health plan.
‘‘(B) Health insurance coverage.
‘‘(C) Part A or part B of title XVIII of the Social
Security Act.
‘‘(D) Title XIX of the Social Security Act, other
than coverage consisting solely of benefits under
section 1928.
‘‘(E) Chapter 55 of title 10.
‘‘(F) A medical care program of the Indian Health
Service or of a tribal organization.
‘‘(G) A State health benefits risk pool.
‘‘(H) A health plan offered under chapter 89 of
title 5.
‘‘(I) A public health plan (as defined in regulations).
‘‘(J) A health benefit plan under section 2504(e) of
title 22.
Such term does not include coverage consisting solely of coverage of excepted benefits (as defined in section 300gg–91(c) of this title).

Page 1283

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(2) NOT COUNTING PERIODS BEFORE SIGNIFICANT
BREAKS IN COVERAGE.—
‘‘(A) IN GENERAL.—A period of creditable coverage
shall not be counted, with respect to enrollment of
an individual under a group health plan, if, after
such period and before the enrollment date, there
was a 63-day period during all of which the individual was not covered under any creditable coverage.
‘‘(B) WAITING PERIOD NOT TREATED AS A BREAK IN
COVERAGE.—For purposes of subparagraph (A) and
subsection (d)(4) of this section, any period that an
individual is in a waiting period for any coverage
under a group health plan (or for group health insurance coverage) or is in an affiliation period (as
defined in subsection (g)(2) of this section) shall not
be taken into account in determining the continuous period under subparagraph (A).
‘‘(C) TAA-ELIGIBLE INDIVIDUALS.—In the case of
plan years beginning before February 13, 2011—
‘‘(i) TAA PRE-CERTIFICATION PERIOD RULE.—In
the case of a TAA-eligible individual, the period
beginning on the date the individual has a TAArelated loss of coverage and ending on the date
that is 7 days after the date of the issuance by the
Secretary (or by any person or entity designated
by the Secretary) of a qualified health insurance
costs credit eligibility certificate for such individual for purposes of section 7527 of title 26 shall
not be taken into account in determining the continuous period under subparagraph (A).
‘‘(ii) DEFINITIONS.—The terms ‘TAA-eligible individual’ and ‘TAA-related loss of coverage’ have
the meanings given such terms in section
300bb–5(b)(4) of this title.
‘‘(3) METHOD OF CREDITING COVERAGE.—
‘‘(A) STANDARD METHOD.—Except as otherwise
provided under subparagraph (B), for purposes of
applying subsection (a)(3) of this section, a group
health plan, and a health insurance issuer offering
group health insurance coverage, shall count a period of creditable coverage without regard to the
specific benefits covered during the period.
‘‘(B) ELECTION OF ALTERNATIVE METHOD.—A group
health plan, or a health insurance issuer offering
group health insurance, may elect to apply subsection (a)(3) of this section based on coverage of
benefits within each of several classes or categories
of benefits specified in regulations rather than as
provided under subparagraph (A). Such election
shall be made on a uniform basis for all participants and beneficiaries. Under such election a
group health plan or issuer shall count a period of
creditable coverage with respect to any class or
category of benefits if any level of benefits is covered within such class or category.
‘‘(C) PLAN NOTICE.—In the case of an election with
respect to a group health plan under subparagraph
(B) (whether or not health insurance coverage is
provided in connection with such plan), the plan
shall—
‘‘(i) prominently state in any disclosure statements concerning the plan, and state to each enrollee at the time of enrollment under the plan,
that the plan has made such election, and
‘‘(ii) include in such statements a description of
the effect of this election.
‘‘(D) ISSUER NOTICE.—In the case of an election
under subparagraph (B) with respect to health insurance coverage offered by an issuer in the small
or large group market, the issuer—
‘‘(i) shall prominently state in any disclosure
statements concerning the coverage, and to each
employer at the time of the offer or sale of the
coverage, that the issuer has made such election,
and
‘‘(ii) shall include in such statements a description of the effect of such election.
‘‘(4) ESTABLISHMENT OF PERIOD.—Periods of creditable coverage with respect to an individual shall be
established through presentation of certifications de-

§ 300gg

scribed in subsection (e) of this section or in such
other manner as may be specified in regulations.
‘‘(d) EXCEPTIONS.—
‘‘(1) EXCLUSION NOT APPLICABLE TO CERTAIN NEWBORNS.—Subject to paragraph (4), a group health
plan, and a health insurance issuer offering group
health insurance coverage, may not impose any preexisting condition exclusion in the case of an individual who, as of the last day of the 30-day period beginning with the date of birth, is covered under creditable coverage.
‘‘(2) EXCLUSION NOT APPLICABLE TO CERTAIN ADOPTED
CHILDREN.—Subject to paragraph (4), a group health
plan, and a health insurance issuer offering group
health insurance coverage, may not impose any preexisting condition exclusion in the case of a child
who is adopted or placed for adoption before attaining 18 years of age and who, as of the last day of the
30-day period beginning on the date of the adoption or
placement for adoption, is covered under creditable
coverage. The previous sentence shall not apply to
coverage before the date of such adoption or placement for adoption.
‘‘(3) EXCLUSION NOT APPLICABLE TO PREGNANCY.—A
group health plan, and health insurance issuer offering group health insurance coverage, may not impose
any preexisting condition exclusion relating to pregnancy as a preexisting condition.
‘‘(4) LOSS IF BREAK IN COVERAGE.—Paragraphs (1)
and (2) shall no longer apply to an individual after
the end of the first 63-day period during all of which
the individual was not covered under any creditable
coverage.
‘‘(e) CERTIFICATIONS AND DISCLOSURE OF COVERAGE.—
‘‘(1) REQUIREMENT FOR CERTIFICATION OF PERIOD OF
CREDITABLE COVERAGE.—
‘‘(A) IN GENERAL.—A group health plan, and a
health insurance issuer offering group health insurance coverage, shall provide the certification described in subparagraph (B)—
‘‘(i) at the time an individual ceases to be covered under the plan or otherwise becomes covered
under a COBRA continuation provision,
‘‘(ii) in the case of an individual becoming covered under such a provision, at the time the individual ceases to be covered under such provision,
and
‘‘(iii) on the request on behalf of an individual
made not later than 24 months after the date of
cessation of the coverage described in clause (i) or
(ii), whichever is later.
The certification under clause (i) may be provided,
to the extent practicable, at a time consistent with
notices required under any applicable COBRA continuation provision.
‘‘(B) CERTIFICATION.—The certification described
in this subparagraph is a written certification of—
‘‘(i) the period of creditable coverage of the individual under such plan and the coverage (if any)
under such COBRA continuation provision, and
‘‘(ii) the waiting period (if any) (and affiliation
period, if applicable) imposed with respect to the
individual for any coverage under such plan.
‘‘(C) ISSUER COMPLIANCE.—To the extent that
medical care under a group health plan consists of
group health insurance coverage, the plan is
deemed to have satisfied the certification requirement under this paragraph if the health insurance
issuer offering the coverage provides for such certification in accordance with this paragraph.
‘‘(2) DISCLOSURE OF INFORMATION ON PREVIOUS BENEFITS.—In the case of an election described in subsection (c)(3)(B) of this section by a group health plan
or health insurance issuer, if the plan or issuer enrolls an individual for coverage under the plan and
the individual provides a certification of coverage of
the individual under paragraph (1)—
‘‘(A) upon request of such plan or issuer, the entity which issued the certification provided by the
individual shall promptly disclose to such request-

§ 300gg

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ing plan or issuer information on coverage of classes and categories of health benefits available under
such entity’s plan or coverage, and
‘‘(B) such entity may charge the requesting plan
or issuer for the reasonable cost of disclosing such
information.
‘‘(3) REGULATIONS.—The Secretary shall establish
rules to prevent an entity’s failure to provide information under paragraph (1) or (2) with respect to previous coverage of an individual from adversely affecting any subsequent coverage of the individual under
another group health plan or health insurance coverage.
‘‘(f) SPECIAL ENROLLMENT PERIODS.—
‘‘(1) INDIVIDUALS LOSING OTHER COVERAGE.—A group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, shall permit an employee who is
eligible, but not enrolled, for coverage under the
terms of the plan (or a dependent of such an employee
if the dependent is eligible, but not enrolled, for coverage under such terms) to enroll for coverage under
the terms of the plan if each of the following conditions is met:
‘‘(A) The employee or dependent was covered
under a group health plan or had health insurance
coverage at the time coverage was previously offered to the employee or dependent.
‘‘(B) The employee stated in writing at such time
that coverage under a group health plan or health
insurance coverage was the reason for declining enrollment, but only if the plan sponsor or issuer (if
applicable) required such a statement at such time
and provided the employee with notice of such requirement (and the consequences of such requirement) at such time.
‘‘(C) The employee’s or dependent’s coverage described in subparagraph (A)—
‘‘(i) was under a COBRA continuation provision
and the coverage under such provision was exhausted; or
‘‘(ii) was not under such a provision and either
the coverage was terminated as a result of loss of
eligibility for the coverage (including as a result
of legal separation, divorce, death, termination of
employment, or reduction in the number of hours
of employment) or employer contributions toward
such coverage were terminated.
‘‘(D) Under the terms of the plan, the employee
requests such enrollment not later than 30 days
after the date of exhaustion of coverage described
in subparagraph (C)(i) or termination of coverage or
employer contribution described in subparagraph
(C)(ii).
‘‘(2) FOR DEPENDENT BENEFICIARIES.—
‘‘(A) IN GENERAL.—If—
‘‘(i) a group health plan makes coverage available with respect to a dependent of an individual,
‘‘(ii) the individual is a participant under the
plan (or has met any waiting period applicable to
becoming a participant under the plan and is eligible to be enrolled under the plan but for a failure to enroll during a previous enrollment period), and
‘‘(iii) a person becomes such a dependent of the
individual through marriage, birth, or adoption
or placement for adoption,
the group health plan shall provide for a dependent
special enrollment period described in subparagraph (B) during which the person (or, if not otherwise enrolled, the individual) may be enrolled under
the plan as a dependent of the individual, and in the
case of the birth or adoption of a child, the spouse
of the individual may be enrolled as a dependent of
the individual if such spouse is otherwise eligible
for coverage.
‘‘(B) DEPENDENT SPECIAL ENROLLMENT PERIOD.—A
dependent special enrollment period under this subparagraph shall be a period of not less than 30 days
and shall begin on the later of—

Page 1284

‘‘(i) the date dependent coverage is made available, or
‘‘(ii) the date of the marriage, birth, or adoption
or placement for adoption (as the case may be)
described in subparagraph (A)(iii).
‘‘(C) NO WAITING PERIOD.—If an individual seeks to
enroll a dependent during the first 30 days of such
a dependent special enrollment period, the coverage
of the dependent shall become effective—
‘‘(i) in the case of marriage, not later than the
first day of the first month beginning after the
date the completed request for enrollment is received;
‘‘(ii) in the case of a dependent’s birth, as of the
date of such birth; or
‘‘(iii) in the case of a dependent’s adoption or
placement for adoption, the date of such adoption
or placement for adoption.
‘‘(3) SPECIAL RULES FOR APPLICATION IN CASE OF
MEDICAID AND CHIP.—
‘‘(A) IN GENERAL.—A group health plan, and a
health insurance issuer offering group health insurance coverage in connection with a group health
plan, shall permit an employee who is eligible, but
not enrolled, for coverage under the terms of the
plan (or a dependent of such an employee if the dependent is eligible, but not enrolled, for coverage
under such terms) to enroll for coverage under the
terms of the plan if either of the following conditions is met:
‘‘(i) TERMINATION OF MEDICAID OR CHIP COVERAGE.—The employee or dependent is covered
under a Medicaid plan under title XIX of the Social Security Act or under a State child health
plan under title XXI of such Act and coverage of
the employee or dependent under such a plan is
terminated as a result of loss of eligibility for
such coverage and the employee requests coverage under the group health plan (or health insurance coverage) not later than 60 days after the
date of termination of such coverage.
‘‘(ii) ELIGIBILITY FOR EMPLOYMENT ASSISTANCE
UNDER MEDICAID OR CHIP.—The employee or dependent becomes eligible for assistance, with respect to coverage under the group health plan or
health insurance coverage, under such Medicaid
plan or State child health plan (including under
any waiver or demonstration project conducted
under or in relation to such a plan), if the employee requests coverage under the group health
plan or health insurance coverage not later than
60 days after the date the employee or dependent
is determined to be eligible for such assistance.
‘‘(B) COORDINATION WITH MEDICAID AND CHIP.—
‘‘(i) OUTREACH TO EMPLOYEES REGARDING AVAILABILITY OF MEDICAID AND CHIP COVERAGE.—
‘‘(I) IN GENERAL.—Each employer that maintains a group health plan in a State that provides medical assistance under a State Medicaid
plan under title XIX of the Social Security Act,
or child health assistance under a State child
health plan under title XXI of such Act, in the
form of premium assistance for the purchase of
coverage under a group health plan, shall provide to each employee a written notice informing the employee of potential opportunities
then currently available in the State in which
the employee resides for premium assistance
under such plans for health coverage of the employee or the employee’s dependents. For purposes of compliance with this subclause, the
employer may use any State-specific model notice developed in accordance with section
1181(f)(3)(B)(i)(II) of title 29.
‘‘(II) OPTION TO PROVIDE CONCURRENT WITH
PROVISION OF PLAN MATERIALS TO EMPLOYEE.—An
employer may provide the model notice applicable to the State in which an employee resides
concurrent with the furnishing of materials notifying the employee of health plan eligibility,

Page 1285

TITLE 42—THE PUBLIC HEALTH AND WELFARE

concurrent with materials provided to the employee in connection with an open season or
election process conducted under the plan, or
concurrent with the furnishing of the summary
plan description as provided in section 1024(b) of
title 29.
‘‘(ii) DISCLOSURE ABOUT GROUP HEALTH PLAN
BENEFITS TO STATES FOR MEDICAID AND CHIP ELIGIBLE INDIVIDUALS.—In the case of an enrollee in
a group health plan who is covered under a Medicaid plan of a State under title XIX of the Social
Security Act or under a State child health plan
under title XXI of such Act, the plan administrator of the group health plan shall disclose to
the State, upon request, information about the
benefits available under the group health plan in
sufficient specificity, as determined under regulations of the Secretary of Health and Human Services in consultation with the Secretary that require use of the model coverage coordination disclosure form developed under section 311(b)(1)(C)
of the Children’s Health Insurance Reauthorization Act of 2009, so as to permit the State to
make a determination (under paragraph (2)(B),
(3), or (10) of section 2105(c) of the Social Security
Act or otherwise) concerning the cost-effectiveness of the State providing medical or child
health assistance through premium assistance for
the purchase of coverage under such group health
plan and in order for the State to provide supplemental benefits required under paragraph (10)(E)
of such section or other authority.
‘‘(g) USE OF AFFILIATION PERIOD BY HMOS AS ALTERNATIVE TO PREEXISTING CONDITION EXCLUSION.—
‘‘(1) IN GENERAL.—A health maintenance organization which offers health insurance coverage in connection with a group health plan and which does not
impose any preexisting condition exclusion allowed
under subsection (a) of this section with respect to
any particular coverage option may impose an affiliation period for such coverage option, but only if—
‘‘(A) such period is applied uniformly without regard to any health status-related factors; and
‘‘(B) such period does not exceed 2 months (or 3
months in the case of a late enrollee).
‘‘(2) AFFILIATION PERIOD.—
‘‘(A) DEFINED.—For purposes of this subchapter,
the term ‘affiliation period’ means a period which,
under the terms of the health insurance coverage
offered by the health maintenance organization,
must expire before the health insurance coverage
becomes effective. The organization is not required
to provide health care services or benefits during
such period and no premium shall be charged to the
participant or beneficiary for any coverage during
the period.
‘‘(B) BEGINNING.—Such period shall begin on the
enrollment date.
‘‘(C) RUNS CONCURRENTLY WITH WAITING PERIODS.—
An affiliation period under a plan shall run concurrently with any waiting period under the plan.
‘‘(3) ALTERNATIVE METHODS.—A health maintenance
organization described in paragraph (1) may use alternative methods, from those described in such paragraph, to address adverse selection as approved by
the State insurance commissioner or official or officials designated by the State to enforce the requirements of this part for the State involved with respect
to such issuer.’’
Another prior section 2701 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238 of this title.
AMENDMENTS
2010—Subsec. (a)(5). Pub. L. 111–148, § 10103(a), inserted
‘‘(other than self-insured group health plans offered in
such market)’’ after ‘‘such market’’.
EFFECTIVE DATE
Pub. L. 111–148, title I, § 1255, formerly § 1253, title X,
§ 10103(e), (f)(1), Mar. 23, 2010, 124 Stat. 162, 895, provided

§ 300gg

that: ‘‘This subtitle [subtitle C (§§ 1201–1255) of title I of
Pub. L. 111–148, enacting subchapter II of chapter 157 of
this title and sections 300gg to 300gg–2 and 300gg–4 to
300gg–7 of this title, and amending sections 300gg–1 and
300gg–4 of this title and transferring former section
300gg of this title to section 300gg–3 of this title] (and
the amendments made by this subtitle) shall become
effective for plan years beginning on or after January
1, 2014, except that—
‘‘(1) section 1251 [enacting section 18011 of this title]
shall take effect on the date of enactment of this Act
[Mar. 23, 2010]; and
‘‘(2) the provisions of section 2704 of the Public
Health Service Act [42 U.S.C. 300gg–3] (as amended by
section 1201), as they apply to enrollees who are
under 19 years of age, shall become effective for plan
years beginning on or after the date that is 6 months
after the date of enactment of this Act [Mar. 23,
2010].. [sic]’’
Pub. L. 104–191, title I, § 102(c), Aug. 21, 1996, 110 Stat.
1976, provided that:
‘‘(1) IN GENERAL.—Except as provided in this subsection, part A of title XXVII of the Public Health
Service Act [42 U.S.C. 300gg et seq.] (as added by subsection (a)) shall apply with respect to group health
plans, and health insurance coverage offered in connection with group health plans, for plan years beginning
after June 30, 1997.
‘‘(2) DETERMINATION OF CREDITABLE COVERAGE.—
‘‘(A) PERIOD OF COVERAGE.—
‘‘(i) IN GENERAL.—Subject to clause (ii), no period
before July 1, 1996, shall be taken into account
under part A of title XXVII of the Public Health
Service Act [42 U.S.C. 300gg et seq.] (as added by
this section) in determining creditable coverage.
‘‘(ii) SPECIAL RULE FOR CERTAIN PERIODS.—The
Secretary of Health and Human Services, consistent with section 104 [set out as a note under section
300gg–92 of this title], shall provide for a process
whereby individuals who need to establish creditable coverage for periods before July 1, 1996, and
who would have such coverage credited but for
clause (i) may be given credit for creditable coverage for such periods through the presentation of
documents or other means.
‘‘(B) CERTIFICATIONS, ETC.—
‘‘(i) IN GENERAL.—Subject to clauses (ii) and (iii),
subsection (e) of section 2701 [now 2704] of the Public Health Service Act [42 U.S.C. 300gg–3(e)] (as
added by this section) shall apply to events occurring after June 30, 1996.
‘‘(ii) NO CERTIFICATION REQUIRED TO BE PROVIDED
BEFORE JUNE 1, 1997.—In no case is a certification required to be provided under such subsection before
June 1, 1997.
‘‘(iii) CERTIFICATION ONLY ON WRITTEN REQUEST
FOR EVENTS OCCURRING BEFORE OCTOBER 1, 1996.—In
the case of an event occurring after June 30, 1996,
and before October 1, 1996, a certification is not required to be provided under such subsection unless
an individual (with respect to whom the certification is otherwise required to be made) requests
such certification in writing.
‘‘(C) TRANSITIONAL RULE.—In the case of an individual who seeks to establish creditable coverage for any
period for which certification is not required because
it relates to an event occurring before June 30, 1996—
‘‘(i) the individual may present other credible evidence of such coverage in order to establish the period of creditable coverage; and
‘‘(ii) a group health plan and a health insurance
issuer shall not be subject to any penalty or enforcement action with respect to the plan’s or issuer’s crediting (or not crediting) such coverage if the
plan or issuer has sought to comply in good faith
with the applicable requirements under the amendments made by this section [enacting this section
and sections 300gg–1, 300gg–11 to 300gg–13, 300gg–21
to 300gg–23, 300gg–91, and 300gg–92 of this title and
amending sections 300e and 300bb–8 of this title].

§ 300gg–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(3) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—Except as provided in paragraph (2)(B), in the
case of a group health plan maintained pursuant to 1 or
more collective bargaining agreements between employee representatives and one or more employers ratified before the date of the enactment of this Act [Aug.
21, 1996], part A of title XXVII of the Public Health
Service Act [42 U.S.C. 300gg et seq.] (other than section
2701(e) [now 2704(e)] thereof [42 U.S.C. 300gg–3(e)]) shall
not apply to plan years beginning before the later of—
‘‘(A) the date on which the last of the collective
bargaining agreements relating to the plan terminates (determined without regard to any extension
thereof agreed to after the date of the enactment of
this Act), or
‘‘(B) July 1, 1997.
For purposes of subparagraph (A), any plan amendment
made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement of such part shall not be
treated as a termination of such collective bargaining
agreement.
‘‘(4) TIMELY REGULATIONS.—The Secretary of Health
and Human Services, consistent with section 104 [set
out as a note under section 300gg–92 of this title], shall
first issue by not later than April 1, 1997, such regulations as may be necessary to carry out the amendments
made by this section [enacting this section and sections 300gg–1, 300gg–11 to 300gg–13, 300gg–21 to 300gg–23,
300gg–91, and 300gg–92 of this title and amending sections 300e and 300bb–8 of this title] and section 111 [enacting sections 300gg–41 to 300gg–44 and 300gg–61 to
300gg–63 of this title].
‘‘(5) LIMITATION ON ACTIONS.—No enforcement action
shall be taken, pursuant to the amendments made by
this section, against a group health plan or health insurance issuer with respect to a violation of a requirement imposed by such amendments before January 1,
1998, or, if later, the date of issuance of regulations referred to in paragraph (4), if the plan or issuer has
sought to comply in good faith with such requirements.’’
CONGRESSIONAL FINDINGS RELATING TO EXERCISE OF
COMMERCE CLAUSE AUTHORITY; SEVERABILITY
Pub. L. 104–191, title I, § 195, Aug. 21, 1996, 110 Stat.
1991, provided that:
‘‘(a) FINDINGS RELATING TO EXERCISE OF COMMERCE
CLAUSE AUTHORITY.—Congress finds the following in relation to the provisions of this title [enacting this subchapter and sections 1181 to 1183 and 1191 to 1191c of
Title 29, Labor, amending sections 233, 300e, and 300bb–8
of this title and sections 1003, 1021, 1022, 1024, 1132, 1136,
and 1144 of Title 29, and enacting provisions set out as
notes under this section, section 300gg–92 of this title,
and section 1181 of Title 29]:
‘‘(1) Provisions in group health plans and health insurance coverage that impose certain preexisting
condition exclusions impact the ability of employees
to seek employment in interstate commerce, thereby
impeding such commerce.
‘‘(2) Health insurance coverage is commercial in nature and is in and affects interstate commerce.
‘‘(3) It is a necessary and proper exercise of Congressional authority to impose requirements under
this title on group health plans and health insurance
coverage (including coverage offered to individuals
previously covered under group health plans) in order
to promote commerce among the States.
‘‘(4) Congress, however, intends to defer to States,
to the maximum extent practicable, in carrying out
such requirements with respect to insurers and
health maintenance organizations that are subject to
State regulation, consistent with the provisions of
the Employee Retirement Income Security Act of
1974 [29 U.S.C. 1001 et seq.].
‘‘(b) SEVERABILITY.—If any provision of this title or
the application of such provision to any person or circumstance is held to be unconstitutional, the remainder of this title and the application of the provisions of

Page 1286

such to any person or circumstance shall not be affected thereby.’’
HEALTH COVERAGE AVAILABILITY STUDIES
Pub. L. 104–191, title I, § 191, Aug. 21, 1996, 110 Stat.
1987, directed the Secretary of Health and Human Services to provide for a study on the effectiveness of the
provisions of title I of Pub. L. 104–191 and the various
State laws, in ensuring the availability of reasonably
priced health coverage to employers and individuals
and a study on access to, and choice of, health care providers and the cost and cost-effectiveness to health insurance issuers of providing access to out-of-network
providers, and the potential impact of providing such
access on the cost and quality of health insurance coverage, and to report to the appropriate committees of
Congress on each of such studies not later than Jan. 1,
2000.

§ 300gg–1. Guaranteed availability of coverage
(a) Guaranteed issuance of coverage in the individual and group market
Subject to subsections (b) through (e),1 each
health insurance issuer that offers health insurance coverage in the individual or group market
in a State must accept every employer and individual in the State that applies for such coverage.
(b) Enrollment
(1) Restriction
A health insurance issuer described in subsection (a) may restrict enrollment in coverage described in such subsection to open or
special enrollment periods.
(2) Establishment
A health insurance issuer described in subsection (a) shall, in accordance with the regulations promulgated under paragraph (3), establish special enrollment periods for qualifying events (under section 1163 of title 29).
(3) Regulations
The Secretary shall promulgate regulations
with respect to enrollment periods under paragraphs (1) and (2).
(c) Special rules for network plans
(1) In general
In the case of a health insurance issuer that
offers health insurance coverage in the group
and individual market through a network
plan, the issuer may—
(A) limit the employers that may apply for
such coverage to those with eligible individuals who live, work, or reside in the service
area for such network plan; and
(B) within the service area of such plan,
deny such coverage to such employers and
individuals if the issuer has demonstrated, if
required, to the applicable State authority
that—
(i) it will not have the capacity to deliver services adequately to enrollees of
any additional groups or any additional individuals because of its obligations to existing group contract holders and enrollees, and
(ii) it is applying this paragraph uniformly to all employers and individuals
1 So

in original.

Page 1287

TITLE 42—THE PUBLIC HEALTH AND WELFARE

without regard to the claims experience of
those individuals, employers and their employees (and their dependents) or any
health status-related factor relating to
such individuals 1 employees and dependents.
(2) 180-day suspension upon denial of coverage
An issuer, upon denying health insurance
coverage in any service area in accordance
with paragraph (1)(B), may not offer coverage
in the group or individual market within such
service area for a period of 180 days after the
date such coverage is denied.
(d) Application of financial capacity limits
(1) In general
A health insurance issuer may deny health
insurance coverage in the group or individual
market if the issuer has demonstrated, if required, to the applicable State authority
that—
(A) it does not have the financial reserves
necessary to underwrite additional coverage;
and
(B) it is applying this paragraph uniformly
to all employers and individuals in the group
or individual market in the State consistent
with applicable State law and without regard to the claims experience of those individuals, employers and their employees (and
their dependents) or any health status-related factor relating to such individuals, employees and dependents.
(2) 180-day suspension upon denial of coverage
A health insurance issuer upon denying
health insurance coverage in connection with
group health plans in accordance with paragraph (1) in a State may not offer coverage in
connection with group health plans in the
group or individual market in the State for a
period of 180 days after the date such coverage
is denied or until the issuer has demonstrated
to the applicable State authority, if required
under applicable State law, that the issuer has
sufficient financial reserves to underwrite additional coverage, whichever is later. An applicable State authority may provide for the application of this subsection on a service-areaspecific basis.
(July 1, 1944, ch. 373, title XXVII, § 2702, as added
and amended Pub. L. 111–148, title I, §§ 1201(4),
1563(c)(8),
formerly
§ 1562(c)(8),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 156, 266, 911.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
CODIFICATION
The text of section 300gg–11 of this title, which was
amended and transferred to subsecs. (c) and (d) of this
section by Pub. L. 111–148, § 1563(c)(8), formerly
§ 1562(c)(8), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), was based on act July 1, 1944, ch. 373, title
XXVII, § 2731, formerly § 2711, as added Pub. L. 104–191,
title I, § 102(a), Aug. 21, 1996, 110 Stat. 1962; renumbered
§ 2731, Pub. L. 111–148, title I, § 1001(3), Mar. 23, 2010, 124
Stat. 130. For text of section 300gg–11 prior to amendment and transfer, see Prior Provisions note under section 300gg–11 of this title.

§ 300gg–1

PRIOR PROVISIONS
A prior section 300gg–1, act July 1, 1944, ch. 373, title
XXVII, § 2702, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1961; Pub. L. 110–233, title I,
§ 102(a)(1)–(3), May 21, 2008, 122 Stat. 888, 890, was amended by Pub. L. 111–148, title I, § 1201(3), Mar. 23, 2010, 124
Stat. 154, effective for plan years beginning on or after
Jan. 1, 2014, and was transferred to subsecs. (d) to (f) of
section 300gg–4 of this title. Prior to amendment and
transfer by Pub. L. 111–148, text of section 300gg–1 read
as follows:
‘‘(a) IN ELIGIBILITY TO ENROLL.—
‘‘(1) IN GENERAL.—Subject to paragraph (2), a group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, may not establish rules for eligibility (including continued eligibility) of any individual to enroll under the terms of the plan based on any
of the following health status-related factors in relation to the individual or a dependent of the individual:
‘‘(A) Health status.
‘‘(B) Medical condition (including both physical
and mental illnesses).
‘‘(C) Claims experience.
‘‘(D) Receipt of health care.
‘‘(E) Medical history.
‘‘(F) Genetic information.
‘‘(G) Evidence of insurability (including conditions arising out of acts of domestic violence).
‘‘(H) Disability.
‘‘(2) NO APPLICATION TO BENEFITS OR EXCLUSIONS.—
To the extent consistent with section 300gg of this
title, paragraph (1) shall not be construed—
‘‘(A) to require a group health plan, or group
health insurance coverage, to provide particular
benefits other than those provided under the terms
of such plan or coverage, or
‘‘(B) to prevent such a plan or coverage from establishing limitations or restrictions on the
amount, level, extent, or nature of the benefits or
coverage for similarly situated individuals enrolled
in the plan or coverage.
‘‘(3) CONSTRUCTION.—For purposes of paragraph (1),
rules for eligibility to enroll under a plan include
rules defining any applicable waiting periods for such
enrollment.
‘‘(b) IN PREMIUM CONTRIBUTIONS.—
‘‘(1) IN GENERAL.—A group health plan, and a health
insurance issuer offering health insurance coverage
in connection with a group health plan, may not require any individual (as a condition of enrollment or
continued enrollment under the plan) to pay a premium or contribution which is greater than such premium or contribution for a similarly situated individual enrolled in the plan on the basis of any health
status-related factor in relation to the individual or
to an individual enrolled under the plan as a dependent of the individual.
‘‘(2) CONSTRUCTION.—Nothing in paragraph (1) shall
be construed—
‘‘(A) to restrict the amount that an employer
may be charged for coverage under a group health
plan except as provided in paragraph (3); or
‘‘(B) to prevent a group health plan, and a health
insurance issuer offering group health insurance
coverage, from establishing premium discounts or
rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention.
‘‘(3) NO GROUP-BASED DISCRIMINATION ON BASIS OF GENETIC INFORMATION.—
‘‘(A) IN GENERAL.—For purposes of this section, a
group health plan, and health insurance issuer offering group health insurance coverage in connection with a group health plan, may not adjust premium or contribution amounts for the group covered under such plan on the basis of genetic information.

§ 300gg–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(B) RULE OF CONSTRUCTION.—Nothing in subparagraph (A) or in paragraphs (1) and (2) of subsection
(d) shall be construed to limit the ability of a
health insurance issuer offering health insurance
coverage in connection with a group health plan to
increase the premium for an employer based on the
manifestation of a disease or disorder of an individual who is enrolled in the plan. In such case, the
manifestation of a disease or disorder in one individual cannot also be used as genetic information
about other group members and to further increase
the premium for the employer.
‘‘(c) GENETIC TESTING.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A group health plan, and a health insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request or require an individual or a family member of
such individual to undergo a genetic test.
‘‘(2) RULE OF CONSTRUCTION.—Paragraph (1) shall
not be construed to limit the authority of a health
care professional who is providing health care services to an individual to request that such individual
undergo a genetic test.
‘‘(3) RULE OF CONSTRUCTION REGARDING PAYMENT.—
‘‘(A) IN GENERAL.—Nothing in paragraph (1) shall
be construed to preclude a group health plan, or a
health insurance issuer offering health insurance
coverage in connection with a group health plan,
from obtaining and using the results of a genetic
test in making a determination regarding payment
(as such term is defined for the purposes of applying
the regulations promulgated by the Secretary
under part C of title XI of the Social Security Act
and section 264 of the Health Insurance Portability
and Accountability Act of 1996, as may be revised
from time to time) consistent with subsection (a).
‘‘(B) LIMITATION.—For purposes of subparagraph
(A), a group health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, may request only the
minimum amount of information necessary to accomplish the intended purpose.
‘‘(4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a group health plan, or a health insurance
issuer offering health insurance coverage in connection with a group health plan, may request, but not
require, that a participant or beneficiary undergo a
genetic test if each of the following conditions is
met:
‘‘(A) The request is made pursuant to research
that complies with part 46 of title 45, Code of Federal Regulations, or equivalent Federal regulations,
and any applicable State or local law or regulations
for the protection of human subjects in research.
‘‘(B) The plan or issuer clearly indicates to each
participant or beneficiary, or in the case of a minor
child, to the legal guardian of such beneficiary, to
whom the request is made that—
‘‘(i) compliance with the request is voluntary;
and
‘‘(ii) non-compliance will have no effect on enrollment status or premium or contribution
amounts.
‘‘(C) No genetic information collected or acquired
under this paragraph shall be used for underwriting
purposes.
‘‘(D) The plan or issuer notifies the Secretary in
writing that the plan or issuer is conducting activities pursuant to the exception provided for under
this paragraph, including a description of the activities conducted.
‘‘(E) The plan or issuer complies with such other
conditions as the Secretary may by regulation require for activities conducted under this paragraph.
‘‘(d) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
‘‘(1) IN GENERAL.—A group health plan, and a health
insurance issuer offering health insurance coverage
in connection with a group health plan, shall not re-

Page 1288

quest, require, or purchase genetic information for
underwriting purposes (as defined in section 300gg–91
of this title).
‘‘(2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan,
and a health insurance issuer offering health insurance coverage in connection with a group health
plan, shall not request, require, or purchase genetic
information with respect to any individual prior to
such individual’s enrollment under the plan or coverage in connection with such enrollment.
‘‘(3) INCIDENTAL COLLECTION.—If a group health
plan, or a health insurance issuer offering health insurance coverage in connection with a group health
plan, obtains genetic information incidental to the
requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation
of paragraph (2) if such request, requirement, or purchase is not in violation of paragraph (1).
‘‘(e) APPLICATION TO ALL PLANS.—The provisions of
subsections (a)(1)(F), (b)(3), (c), and (d) and subsection
(b)(1) and section 300gg of this title with respect to genetic information, shall apply to group health plans
and health insurance issuers without regard to section
300gg–21(a) of this title.
‘‘(f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—
Any reference in this part to genetic information concerning an individual or family member of an individual shall—
‘‘(1) with respect to such an individual or family
member of an individual who is a pregnant woman,
include genetic information of any fetus carried by
such pregnant woman; and
‘‘(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include
genetic information of any embryo legally held by
the individual or family member.’’
Another prior section 2702 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238a of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 1563(c)(8), formerly § 1562(c)(8),
as renumbered by Pub. L. 111–148, § 10107(b)(1), transferred section 300gg–11 of this title to the end of this
section after amending it by striking out the section
catchline ‘‘Guaranteed availability of coverage for employers in group market’’, by striking out subsec. (a)
which related to issuance of coverage in small group
market, subsec. (b) which related to assurance of access
in large group market, subsec. (e) which related to exception to requirement for failure to meet certain minimum participation or contribution rules, and subsec.
(f) which related to exception for coverage offered only
to bona fide association members, by amending subsec.
(c) by substituting ‘‘group and individual’’ for ‘‘small
group’’ in introductory provisions of par. (1), inserting
‘‘and individuals’’ after ‘‘employers’’ in introductory
provisions of par. (1)(B), inserting ‘‘or any additional
individuals’’ after ‘‘additional groups’’ in par. (1)(B)(i),
substituting ‘‘and individuals without regard to the
claims experience of those individuals, employers and
their employees (and their dependents) or any health
status-related factor relating to such individuals’’ for
‘‘without regard to the claims experience of those employers and their employees (and their dependents) or
any health status-related factor relating to such’’ in
par. (1)(B)(ii), and substituting ‘‘group or individual’’
for ‘‘small group’’ in par. (2), and by amending subsec.
(d) by substituting ‘‘group or individual’’ for ‘‘small
group’’ wherever appearing and substituting ‘‘all employers and individuals’’ for ‘‘all employers’’, ‘‘those individuals, employers’’ for ‘‘those employers’’, and
‘‘such individuals, employees’’ for ‘‘such employees’’ in
par. (1)(B).
EFFECTIVE DATE
Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

Page 1289

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300gg–2. Guaranteed renewability of coverage
(a) In general
Except as provided in this section, if a health
insurance issuer offers health insurance coverage in the individual or group market, the issuer must renew or continue in force such coverage at the option of the plan sponsor or the individual, as applicable.
(b) General exceptions
A health insurance issuer may nonrenew or
discontinue health insurance coverage offered in
connection with a health insurance coverage offered in the group or individual market based
only on one or more of the following:
(1) Nonpayment of premiums
The plan sponsor, or individual, as applicable, has failed to pay premiums or contributions in accordance with the terms of the
health insurance coverage or the issuer has
not received timely premium payments.
(2) Fraud
The plan sponsor, or individual, as applicable, has performed an act or practice that constitutes fraud or made an intentional misrepresentation of material fact under the
terms of the coverage.
(3) Violation of participation or contribution
rates
In the case of a group health plan, the plan
sponsor has failed to comply with a material
plan provision relating to employer contribution or group participation rules, pursuant to
applicable State law.
(4) Termination of coverage
The issuer is ceasing to offer coverage in
such market in accordance with subsection (c)
of this section and applicable State law.
(5) Movement outside service area
In the case of a health insurance issuer that
offers health insurance coverage in the market
through a network plan, there is no longer any
enrollee in connection with such plan who
lives, resides, or works in the service area of
the issuer (or in the area for which the issuer
is authorized to do business) and, in the case
of the small group market, the issuer would
deny enrollment with respect to such plan
under section 2711(c)(1)(A).1
(6) Association membership ceases
In the case of health insurance coverage
that is made available in the small or large
group market (as the case may be) only
through one or more bona fide associations,
the membership of an employer in the association (on the basis of which the coverage is provided) ceases but only if such coverage is terminated under this paragraph uniformly without regard to any health status-related factor
relating to any covered individual.
(c) Requirements for uniform termination of coverage
(1) Particular type of coverage not offered
In any case in which an issuer decides to discontinue offering a particular type of group or
1 See

References in Text note below.

§ 300gg–2

individual health insurance coverage, coverage
of such type may be discontinued by the issuer
in accordance with applicable State law in
such market only if—
(A) the issuer provides notice to each plan
sponsor or individual, as applicable, provided
coverage of this type in such market (and
participants and beneficiaries covered under
such coverage) of such discontinuation at
least 90 days prior to the date of the discontinuation of such coverage;
(B) the issuer offers to each plan sponsor
or individual, as applicable, provided coverage of this type in such market, the option
to purchase all (or, in the case of the large
group market, any) other health insurance
coverage currently being offered by the issuer to a group health plan or individual
health insurance coverage in such market;
and
(C) in exercising the option to discontinue
coverage of this type and in offering the option of coverage under subparagraph (B), the
issuer acts uniformly without regard to the
claims experience of those sponsors or individuals, as applicable, or any health statusrelated factor relating to any participants or
beneficiaries covered or new participants or
beneficiaries who may become eligible for
such coverage.
(2) Discontinuance of all coverage
(A) In general
In any case in which a health insurance issuer elects to discontinue offering all health
insurance coverage in the individual or
group market, or all markets, in a State,
health insurance coverage may be discontinued by the issuer only in accordance with
applicable State law and if—
(i) the issuer provides notice to the applicable State authority and to each plan
sponsor or individual, as applicable,2 (and
participants and beneficiaries covered
under such coverage) of such discontinuation at least 180 days prior to the date of
the discontinuation of such coverage; and
(ii) all health insurance issued or delivered for issuance in the State in such market (or markets) are discontinued and coverage under such health insurance coverage in such market (or markets) is not
renewed.
(B) Prohibition on market reentry
In the case of a discontinuation under subparagraph (A) in a market, the issuer may
not provide for the issuance of any health insurance coverage in the market and State
involved during the 5-year period beginning
on the date of the discontinuation of the last
health insurance coverage not so renewed.
(d) Exception for uniform modification of coverage
At the time of coverage renewal, a health insurance issuer may modify the health insurance
coverage for a product offered to a group health
plan—
(1) in the large group market; or
2 So

in original.

§ 300gg–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) in the small group market if, for coverage
that is available in such market other than
only through one or more bona fide associations, such modification is consistent with
State law and effective on a uniform basis
among group health plans with that product.
(e) Application to coverage offered only through
associations
In applying this section in the case of health
insurance coverage that is made available by a
health insurance issuer in the small or large
group market to employers only through one or
more associations, a reference to ‘‘plan sponsor’’
is deemed, with respect to coverage provided to
an employer member of the association, to include a reference to such employer.
(July 1, 1944, ch. 373, title XXVII, § 2703, as added
and amended Pub. L. 111–148, title I, §§ 1201(4),
1563(c)(9),
formerly
§ 1562(c)(9),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 156, 267, 911.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
REFERENCES IN TEXT
Section 2711, referred to in subsec. (b)(5), is a reference to section 2711 of act July 1, 1944. Section 2711,
which was classified to section 300gg–11 of this title,
was renumbered section 2731 and amended and transferred by Pub. L. 111–148, title I, §§ 1001(3), 1563(c)(8), formerly § 1562(c)(8), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 130, 266, 911, to the end of section 2702 of act July
1, 1944, as added by Pub. L. 111–148, title I, § 1201(4), Mar.
23, 2010, 124 Stat. 156, and classified to section 300gg–1
of this title. A new section 2711 of act July 1, 1944, related to no lifetime or annual limits, was added by Pub.
L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124 Stat. 131, effective for plan years beginning on or after the date
that is 6 months after Mar. 23, 2010, and is classified to
section 300gg–11 of this title.
CODIFICATION
The text of section 300gg–12 of this title, which was
amended and transferred to subsecs. (b) to (e) of this
section by Pub. L. 111–148, § 1563(c)(9), formerly
§ 1562(c)(9), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), was based on act July 1, 1944, ch. 373, title
XXVII, § 2732, formerly § 2712, as added Pub. L. 104–191,
title I, § 102(a), Aug. 21, 1996, 110 Stat. 1964; renumbered
§ 2732, Pub. L. 111–148, title I, § 1001(3), Mar. 23, 2010, 124
Stat. 130. For text of section 300gg–12 prior to amendment and transfer by Pub. L. 111–148, see Prior Provisions note under section 300gg–12 of this title.
PRIOR PROVISIONS
A prior section 2703 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238b of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 1563(c)(9), formerly § 1562(c)(9),
as renumbered by Pub. L. 111–148, § 10107(b)(1), transferred section 300gg–12 of this title to the end of this
section after amending it by striking out the section
catchline ‘‘Guaranteed renewability of coverage for employers in group market’’, by striking subsec. (a) which
required a health insurance issuer offering coverage in
connection with a group health plan to renew such coverage at the option of the plan sponsor, by amending
subsec. (b) by substituting ‘‘health insurance coverage
offered in the group or individual market’’ for ‘‘group
health plan in the small or large group market’’ in introductory provisions, inserting ‘‘, or individual, as applicable,’’ after ‘‘plan sponsor’’ in pars. (1) and (2), add-

Page 1290

ing par. (3), and striking out former par. (3) which related to violation of participation or contribution
rules, and by amending subsec. (c) by substituting
‘‘group or individual health insurance coverage’’ for
‘‘group health insurance coverage offered in the small
or large group market’’ in introductory provisions of
par. (1), inserting ‘‘or individual, as applicable,’’ after
‘‘plan sponsor’’ in par. (1)(A) and (B), inserting ‘‘or individual health insurance coverage’’ in par. (1)(B), inserting ‘‘or individuals, as applicable,’’ after ‘‘those sponsors’’ in par. (1)(C), substituting ‘‘individual or group
market, or all markets,’’ for ‘‘small group market or
the large group market, or both markets,’’ in introductory provisions of par. (2)(A), and inserting ‘‘or individual, as applicable,’’ after ‘‘plan sponsor’’ in par.
(2)(A)(i). Amendment inserting ‘‘or individual health
insurance coverage’’ in subsec. (c)(1)(B) was executed
by making the insertion after ‘‘or individual health insurance coverage’’ as the probable intent of Congress,
notwithstanding that the directory language did not
specify where in subsec. (c)(1)(B) to make the insertion.
EFFECTIVE DATE
Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

§ 300gg–3. Prohibition of preexisting condition
exclusions or other discrimination based on
health status
(a) In general
A group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any preexisting
condition exclusion with respect to such plan or
coverage.
(b) Definitions
For purposes of this part—
(1) Preexisting condition exclusion
(A) In general
The term ‘‘preexisting condition exclusion’’ means, with respect to coverage, a
limitation or exclusion of benefits relating
to a condition based on the fact that the
condition was present before the date of enrollment for such coverage, whether or not
any medical advice, diagnosis, care, or treatment was recommended or received before
such date.
(B) Treatment of genetic information
Genetic information shall not be treated
as a condition described in subsection (a)(1) 1
of this section in the absence of a diagnosis
of the condition related to such information.
(2) Enrollment date
The term ‘‘enrollment date’’ means, with respect to an individual covered under a group
health plan or health insurance coverage, the
date of enrollment of the individual in the
plan or coverage or, if earlier, the first day of
the waiting period for such enrollment.
(3) Late enrollee
The term ‘‘late enrollee’’ means, with respect to coverage under a group health plan, a
participant or beneficiary who enrolls under
the plan other than during—
(A) the first period in which the individual
is eligible to enroll under the plan, or
1 See

References in Text note below.

Page 1291

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) a special enrollment period under subsection (f) of this section.
(4) Waiting period
The term ‘‘waiting period’’ means, with respect to a group health plan and an individual
who is a potential participant or beneficiary
in the plan, the period that must pass with respect to the individual before the individual is
eligible to be covered for benefits under the
terms of the plan.
(c) Rules relating to crediting previous coverage
(1) ‘‘Creditable coverage’’ defined
For purposes of this subchapter, the term
‘‘creditable coverage’’ means, with respect to
an individual, coverage of the individual under
any of the following:
(A) A group health plan.
(B) Health insurance coverage.
(C) Part A or part B of title XVIII of the
Social Security Act [42 U.S.C. 1395c et seq.,
1395j et seq.].
(D) Title XIX of the Social Security Act
[42 U.S.C. 1396 et seq.], other than coverage
consisting solely of benefits under section
1928 [42 U.S.C. 1396s].
(E) Chapter 55 of title 10.
(F) A medical care program of the Indian
Health Service or of a tribal organization.
(G) A State health benefits risk pool.
(H) A health plan offered under chapter 89
of title 5.
(I) A public health plan (as defined in regulations).
(J) A health benefit plan under section
2504(e) of title 22.
Such term does not include coverage consisting solely of coverage of excepted benefits (as
defined in section 300gg–91(c) of this title).
(2) Not counting periods before significant
breaks in coverage
(A) In general
A period of creditable coverage shall not
be counted, with respect to enrollment of an
individual under a group or individual
health plan, if, after such period and before
the enrollment date, there was a 63-day period during all of which the individual was
not covered under any creditable coverage.
(B) Waiting period not treated as a break in
coverage
For purposes of subparagraph (A) and subsection (d)(4) of this section, any period that
an individual is in a waiting period for any
coverage under a group or individual health
plan (or for group health insurance coverage) or is in an affiliation period (as defined in subsection (g)(2) of this section)
shall not be taken into account in determining the continuous period under subparagraph (A).
(C) TAA-eligible individuals
In the case of plan years beginning before
February 13, 2011—
(i) TAA pre-certification period rule
In the case of a TAA-eligible individual,
the period beginning on the date the indi-

§ 300gg–3

vidual has a TAA-related loss of coverage
and ending on the date that is 7 days after
the date of the issuance by the Secretary
(or by any person or entity designated by
the Secretary) of a qualified health insurance costs credit eligibility certificate for
such individual for purposes of section 7527
of title 26 shall not be taken into account
in determining the continuous period
under subparagraph (A).
(ii) Definitions
The terms ‘‘TAA-eligible individual’’ and
‘‘TAA-related loss of coverage’’ have the
meanings given such terms in section
300bb–5(b)(4) of this title.
(3) Method of crediting coverage
(A) Standard method
Except as otherwise provided under subparagraph (B), for purposes of applying subsection (a)(3) 1 of this section, a group health
plan, and a health insurance issuer offering
group or individual health insurance coverage, shall count a period of creditable coverage without regard to the specific benefits
covered during the period.
(B) Election of alternative method
A group health plan, or a health insurance
issuer offering group or individual health insurance, may elect to apply subsection
(a)(3) 1 of this section based on coverage of
benefits within each of several classes or
categories of benefits specified in regulations rather than as provided under subparagraph (A). Such election shall be made on a
uniform basis for all participants and beneficiaries. Under such election a group health
plan or issuer shall count a period of creditable coverage with respect to any class or
category of benefits if any level of benefits is
covered within such class or category.
(C) Plan notice
In the case of an election with respect to
a group health plan under subparagraph (B)
(whether or not health insurance coverage is
provided in connection with such plan), the
plan shall—
(i) prominently state in any disclosure
statements concerning the plan, and state
to each enrollee at the time of enrollment
under the plan, that the plan has made
such election, and
(ii) include in such statements a description of the effect of this election.
(D) Issuer notice
In the case of an election under subparagraph (B) with respect to health insurance
coverage offered by an issuer in the individual or group group 2 market, the issuer—
(i) shall prominently state in any disclosure statements concerning the coverage,
and to each employer at the time of the
offer or sale of the coverage, that the issuer has made such election, and
(ii) shall include in such statements a
description of the effect of such election.
2 So

in original.

§ 300gg–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) Establishment of period
Periods of creditable coverage with respect
to an individual shall be established through
presentation of certifications described in subsection (e) of this section or in such other
manner as may be specified in regulations.
(d) Exceptions
(1) Exclusion not applicable to certain newborns
Subject to paragraph (4), a group health
plan, and a health insurance issuer offering
group or individual health insurance coverage,
may not impose any preexisting condition exclusion in the case of an individual who, as of
the last day of the 30-day period beginning
with the date of birth, is covered under creditable coverage.
(2) Exclusion not applicable to certain adopted
children
Subject to paragraph (4), a group health
plan, and a health insurance issuer offering
group or individual health insurance coverage,
may not impose any preexisting condition exclusion in the case of a child who is adopted or
placed for adoption before attaining 18 years
of age and who, as of the last day of the 30-day
period beginning on the date of the adoption
or placement for adoption, is covered under
creditable coverage. The previous sentence
shall not apply to coverage before the date of
such adoption or placement for adoption.
(3) Exclusion not applicable to pregnancy
A group health plan, and health insurance
issuer offering group or individual health insurance coverage, may not impose any preexisting condition exclusion relating to pregnancy as a preexisting condition.
(4) Loss if break in coverage
Paragraphs (1) and (2) shall no longer apply
to an individual after the end of the first 63day period during all of which the individual
was not covered under any creditable coverage.
(e) Certifications and disclosure of coverage
(1) Requirement for certification of period of
creditable coverage
(A) In general
A group health plan, and a health insurance issuer offering group or individual
health insurance coverage, shall provide the
certification described in subparagraph (B)—
(i) at the time an individual ceases to be
covered under the plan or otherwise becomes covered under a COBRA continuation provision,
(ii) in the case of an individual becoming
covered under such a provision, at the
time the individual ceases to be covered
under such provision, and
(iii) on the request on behalf of an individual made not later than 24 months after
the date of cessation of the coverage described in clause (i) or (ii), whichever is
later.
The certification under clause (i) may be
provided, to the extent practicable, at a

Page 1292

time consistent with notices required under
any applicable COBRA continuation provision.
(B) Certification
The certification described in this subparagraph is a written certification of—
(i) the period of creditable coverage of
the individual under such plan and the
coverage (if any) under such COBRA continuation provision, and
(ii) the waiting period (if any) (and affiliation period, if applicable) imposed with
respect to the individual for any coverage
under such plan.
(C) Issuer compliance
To the extent that medical care under a
group health plan consists of group health
insurance coverage, the plan is deemed to
have satisfied the certification requirement
under this paragraph if the health insurance
issuer offering the coverage provides for
such certification in accordance with this
paragraph.
(2) Disclosure of information on previous benefits
In the case of an election described in subsection (c)(3)(B) of this section by a group
health plan or health insurance issuer, if the
plan or issuer enrolls an individual for coverage under the plan and the individual provides a certification of coverage of the individual under paragraph (1)—
(A) upon request of such plan or issuer, the
entity which issued the certification provided by the individual shall promptly disclose to such requesting plan or issuer information on coverage of classes and categories
of health benefits available under such entity’s plan or coverage, and
(B) such entity may charge the requesting
plan or issuer for the reasonable cost of disclosing such information.
(3) Regulations
The Secretary shall establish rules to prevent an entity’s failure to provide information
under paragraph (1) or (2) with respect to previous coverage of an individual from adversely
affecting any subsequent coverage of the individual under another group health plan or
health insurance coverage.
(f) Special enrollment periods
(1) Individuals losing other coverage
A group health plan, and a health insurance
issuer offering group health insurance coverage in connection with a group health plan,
shall permit an employee who is eligible, but
not enrolled, for coverage under the terms of
the plan (or a dependent of such an employee
if the dependent is eligible, but not enrolled,
for coverage under such terms) to enroll for
coverage under the terms of the plan if each of
the following conditions is met:
(A) The employee or dependent was covered under a group health plan or had health
insurance coverage at the time coverage was
previously offered to the employee or dependent.

Page 1293

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) The employee stated in writing at such
time that coverage under a group health
plan or health insurance coverage was the
reason for declining enrollment, but only if
the plan sponsor or issuer (if applicable) required such a statement at such time and
provided the employee with notice of such
requirement (and the consequences of such
requirement) at such time.
(C) The employee’s or dependent’s coverage described in subparagraph (A)—
(i) was under a COBRA continuation provision and the coverage under such provision was exhausted; or
(ii) was not under such a provision and
either the coverage was terminated as a
result of loss of eligibility for the coverage
(including as a result of legal separation,
divorce, death, termination of employment, or reduction in the number of hours
of employment) or employer contributions
toward such coverage were terminated.
(D) Under the terms of the plan, the employee requests such enrollment not later
than 30 days after the date of exhaustion of
coverage described in subparagraph (C)(i) or
termination of coverage or employer contribution described in subparagraph (C)(ii).
(2) For dependent beneficiaries
(A) In general
If—
(i) a group health plan makes coverage
available with respect to a dependent of an
individual,
(ii) the individual is a participant under
the plan (or has met any waiting period
applicable to becoming a participant under
the plan and is eligible to be enrolled
under the plan but for a failure to enroll
during a previous enrollment period), and
(iii) a person becomes such a dependent
of the individual through marriage, birth,
or adoption or placement for adoption,
the group health plan shall provide for a dependent special enrollment period described
in subparagraph (B) during which the person
(or, if not otherwise enrolled, the individual)
may be enrolled under the plan as a dependent of the individual, and in the case of the
birth or adoption of a child, the spouse of
the individual may be enrolled as a dependent of the individual if such spouse is otherwise eligible for coverage.
(B) Dependent special enrollment period
A dependent special enrollment period
under this subparagraph shall be a period of
not less than 30 days and shall begin on the
later of—
(i) the date dependent coverage is made
available, or
(ii) the date of the marriage, birth, or
adoption or placement for adoption (as the
case may be) described in subparagraph
(A)(iii).
(C) No waiting period
If an individual seeks to enroll a dependent during the first 30 days of such a dependent special enrollment period, the coverage
of the dependent shall become effective—

§ 300gg–3

(i) in the case of marriage, not later than
the first day of the first month beginning
after the date the completed request for
enrollment is received;
(ii) in the case of a dependent’s birth, as
of the date of such birth; or
(iii) in the case of a dependent’s adoption
or placement for adoption, the date of such
adoption or placement for adoption.
(3) Special rules for application in case of Medicaid and CHIP
(A) In general
A group health plan, and a health insurance issuer offering group health insurance
coverage in connection with a group health
plan, shall permit an employee who is eligible, but not enrolled, for coverage under the
terms of the plan (or a dependent of such an
employee if the dependent is eligible, but
not enrolled, for coverage under such terms)
to enroll for coverage under the terms of the
plan if either of the following conditions is
met:
(i) Termination of Medicaid or CHIP coverage
The employee or dependent is covered
under a Medicaid plan under title XIX of
the Social Security Act [42 U.S.C. 1396 et
seq.] or under a State child health plan
under title XXI of such Act [42 U.S.C.
1397aa et seq.] and coverage of the employee or dependent under such a plan is
terminated as a result of loss of eligibility
for such coverage and the employee requests coverage under the group health
plan (or health insurance coverage) not
later than 60 days after the date of termination of such coverage.
(ii) Eligibility for employment assistance
under Medicaid or CHIP
The employee or dependent becomes eligible for assistance, with respect to coverage under the group health plan or
health insurance coverage, under such
Medicaid plan or State child health plan
(including under any waiver or demonstration project conducted under or in relation
to such a plan), if the employee requests
coverage under the group health plan or
health insurance coverage not later than
60 days after the date the employee or dependent is determined to be eligible for
such assistance.
(B) Coordination with Medicaid and CHIP
(i) Outreach to employees regarding availability of Medicaid and CHIP coverage
(I) In general
Each employer that maintains a group
health plan in a State that provides medical assistance under a State Medicaid
plan under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], or child
health assistance under a State child
health plan under title XXI of such Act
[42 U.S.C. 1397aa et seq.], in the form of
premium assistance for the purchase of
coverage under a group health plan, shall

§ 300gg–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

provide to each employee a written notice informing the employee of potential
opportunities then currently available in
the State in which the employee resides
for premium assistance under such plans
for health coverage of the employee or
the employee’s dependents. For purposes
of compliance with this subclause, the
employer may use any State-specific
model notice developed in accordance
with section 1181(f)(3)(B)(i)(II) of title 29.
(II) Option to provide concurrent with
provision of plan materials to employee
An employer may provide the model
notice applicable to the State in which
an employee resides concurrent with the
furnishing of materials notifying the employee of health plan eligibility, concurrent with materials provided to the employee in connection with an open season
or election process conducted under the
plan, or concurrent with the furnishing
of the summary plan description as provided in section 1024(b) of title 29.
(ii) Disclosure about group health plan
benefits to States for Medicaid and
CHIP eligible individuals
In the case of an enrollee in a group
health plan who is covered under a Medicaid plan of a State under title XIX of the
Social Security Act [42 U.S.C. 1396 et seq.]
or under a State child health plan under
title XXI of such Act [42 U.S.C. 1397aa et
seq.], the plan administrator of the group
health plan shall disclose to the State,
upon request, information about the benefits available under the group health plan
in sufficient specificity, as determined
under regulations of the Secretary of
Health and Human Services in consultation with the Secretary that require use of
the model coverage coordination disclosure
form
developed
under
section
311(b)(1)(C) of the Children’s Health Insurance 3 Reauthorization Act of 2009, so as to
permit the State to make a determination
(under paragraph (2)(B), (3), or (10) of section 2105(c) of the Social Security Act [42
U.S.C. 1397ee(c)(2)(B), (3), (10)] or otherwise) concerning the cost-effectiveness of
the State providing medical or child
health assistance through premium assistance for the purchase of coverage under
such group health plan and in order for the
State to provide supplemental benefits required under paragraph (10)(E) of such section or other authority.
(g) Use of affiliation period by HMOs as alternative to preexisting condition exclusion
(1) In general
A health maintenance organization which
offers health insurance coverage in connection
with a group health plan and which does not
impose any preexisting condition exclusion allowed under subsection (a) of this section with
3 So in original. Probably should be followed by the word ‘‘Program’’.

Page 1294

respect to any particular coverage option may
impose an affiliation period for such coverage
option, but only if—
(A) such period is applied uniformly without regard to any health status-related factors; and
(B) such period does not exceed 2 months
(or 3 months in the case of a late enrollee).
(2) Affiliation period
(A) ‘‘Affiliation period’’ defined
For purposes of this subchapter, the term
‘‘affiliation period’’ means a period which,
under the terms of the health insurance coverage offered by the health maintenance organization, must expire before the health insurance coverage becomes effective. The organization is not required to provide health
care services or benefits during such period
and no premium shall be charged to the participant or beneficiary for any coverage during the period.
(B) Beginning
Such period shall begin on the enrollment
date.
(C) Runs concurrently with waiting periods
An affiliation period under a plan shall run
concurrently with any waiting period under
the plan.
(3) Alternative methods
A health maintenance organization described in paragraph (1) may use alternative
methods, from those described in such paragraph, to address adverse selection as approved by the State insurance commissioner
or official or officials designated by the State
to enforce the requirements of this part for
the State involved with respect to such issuer.
(July 1, 1944, ch. 373, title XXVII, § 2704, formerly
§ 2701, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1955; amended Pub. L.
111–3, title III, § 311(b)(2), Feb. 4, 2009, 123 Stat.
70; Pub. L. 111–5, div. B, title I, § 1899D(c), Feb.
17, 2009, 123 Stat. 426; renumbered § 2704 and
amended Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1),
formerly
§ 1562(c)(1),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911;
Pub. L. 111–344, title I, § 114(c), Dec. 29, 2010, 124
Stat. 3615.)
AMENDMENT OF SECTION
For delayed effective date of amendment and
renumbering by section 1201(2) of Pub. L.
111–148, see Effective Date of 2010 Amendment
note below.
REFERENCES IN TEXT
Subsection (a) of this section, referred to in subsecs.
(b)(1)(B) and (c)(3)(A), (B), was struck out, and a new
subsec. (a) was added, by Pub. L. 111–148, title I,
§ 1201(2)(A), Mar. 23, 2010, 124 Stat. 154, and as so amended, subsec. (a) no longer contains paragraphs.
The Social Security Act, referred to in subsecs.
(c)(1)(C), (D) and (f)(3)(A)(i), (B)(i)(I), (ii), is act Aug. 14,
1935, ch. 531, 49 Stat. 620. Parts A and B of title XVIII
of the Act are classified generally to parts A (§ 1395c et
seq.) and B (§ 1395j et seq.), respectively, of subchapter
XVIII of chapter 7 of this title. Titles XIX and XXI of
the Act are classified generally to subchapters XIX
(§ 1396 et seq.) and XXI (§ 1397aa et seq.), respectively, of

Page 1295

TITLE 42—THE PUBLIC HEALTH AND WELFARE

chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.
Section 311(b)(1)(C) of the Children’s Health Insurance Program Reauthorization Act of 2009, referred to
in subsec. (f)(3)(B)(ii), is section 311(b)(1)(C) of Pub. L.
111–3, which is set out as a note under section 1181 of
Title 29, Labor.
CODIFICATION
Section was classified to
prior to amendment and
111–148. For text of section
and renumbering, see Prior
tion 300gg of this title.

section 300gg of this title
renumbering by Pub. L.
300gg prior to amendment
Provisions note under sec-

PRIOR PROVISIONS
A prior section 2704 of act July 1, 1944, was renumbered section 2725 and is classified to section 300gg–25 of
this title.
Another prior section 2704 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238c of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 1201(2)(A), substituted ‘‘Prohibition of preexisting condition exclusions or other discrimination based on health status’’ for ‘‘Increased
portability through limitation on preexisting condition
exclusions’’ in section catchline, added subsec. (a), and
struck out former subsec. (a) which related to limitation on preexisting condition exclusion period.
Subsec. (c)(2)(A), (B). Pub. L. 111–148, § 1563(c)(1)(A)(i),
formerly § 1562(c)(1)(A)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘group or individual
health plan’’ for ‘‘group health plan’’.Subsec. (c)(2)(C).
Pub. L. 111–344 substituted ‘‘February 13, 2011’’ for
‘‘January 1, 2011’’ in introductory provisions.
Subsec.
(c)(3)(A),
(B).
Pub.
L.
111–148,
§ 1563(c)(1)(A)(ii)(I), formerly § 1562(c)(1)(A)(ii)(I), as renumbered by Pub. L. 111–148, § 10107(b)(1), substituted
‘‘group or individual health insurance’’ for ‘‘group
health insurance’’.
Subsec. (c)(3)(D). Pub. L. 111–148, § 1563(c)(1)(A)(ii)(II),
formerly § 1562(c)(1)(A)(ii)(II), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘individual or group’’
for ‘‘small or large’’ in introductory provisions.
Subsec. (d)(1) to (3). Pub. L. 111–148, § 1563(c)(1)(B), formerly § 1562(c)(1)(B), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘group or individual health insurance’’ for ‘‘group health insurance’’.
Subsec. (e)(1)(A). Pub. L. 111–148, § 1563(c)(1)(C), formerly § 1562(c)(1)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘group or individual health insurance’’ for ‘‘group health insurance’’ in introductory
provisions.
2009—Subsec. (c)(2)(C). Pub. L. 111–5 added subpar. (C).
Subsec. (f)(3). Pub. L. 111–3 added par. (3).
EFFECTIVE DATE OF 2010 AMENDMENT
Amendment by Pub. L. 111–344 applicable to plan
years beginning after Dec. 31, 2010, see section 114(d) of
Pub. L. 111–344, set out as a note under section 9801 of
Title 26, Internal Revenue Code.
Amendment by section 1201(2) of Pub. L. 111–148 effective for plan years beginning on or after Jan. 1, 2014, except that the provisions of this section, as they apply
to enrollees who are under 19 years of age, effective for
plan years beginning on or after the date that is 6
months after Mar. 23, 2010, see section 1255 of Pub. L.
111–148, set out as an Effective Date note under section
300gg of this title.
EFFECTIVE DATE OF 2009 AMENDMENT
Except as otherwise provided and subject to certain
applicability provisions, amendment by Pub. L. 111–5
effective upon the expiration of the 90-day period beginning on Feb. 17, 2009, see section 1891 of Pub. L. 111–5,
set out as an Effective and Termination Dates of 2009

§ 300gg–4

Amendment note under section 2271 of Title 19, Customs Duties.
Amendment by Pub. L. 111–5 applicable to plan years
beginning after Feb. 17, 2009, see section 1899D(d) of
Pub. L. 111–5, set out as a note under section 9801 of
Title 26, Internal Revenue Code.
Amendment by Pub. L. 111–3 effective Apr. 1, 2009, and
applicable to child health assistance and medical assistance provided on or after that date, with certain exceptions, see section 3 of Pub. L. 111–3, set out as an Effective Date note under section 1396 of this title.

§ 300gg–4. Prohibiting discrimination against individual participants and beneficiaries based
on health status
(a) In general
A group health plan and a health insurance issuer offering group or individual health insurance coverage may not establish rules for eligibility (including continued eligibility) of any individual to enroll under the terms of the plan or
coverage based on any of the following health
status-related factors in relation to the individual or a dependent of the individual:
(1) Health status.
(2) Medical condition (including both physical and mental illnesses).
(3) Claims experience.
(4) Receipt of health care.
(5) Medical history.
(6) Genetic information.
(7) Evidence of insurability (including conditions arising out of acts of domestic violence).
(8) Disability.
(9) Any other health status-related factor determined appropriate by the Secretary.
(b) In premium contributions
(1) In general
A group health plan, and a health insurance
issuer offering group or individual health insurance coverage, may not require any individual (as a condition of enrollment or continued enrollment under the plan) to pay a
premium or contribution which is greater
than such premium or contribution for a similarly situated individual enrolled in the plan
on the basis of any health status-related factor in relation to the individual or to an individual enrolled under the plan as a dependent
of the individual.
(2) Construction
Nothing in paragraph (1) shall be construed—
(A) to restrict the amount that an employer or individual may be charged for coverage under a group health plan except as
provided in paragraph (3) or individual
health coverage, as the case may be; or
(B) to prevent a group health plan, and a
health insurance issuer offering group
health insurance coverage, from establishing
premium discounts or rebates or modifying
otherwise applicable copayments or deductibles in return for adherence to programs of
health promotion and disease prevention.
(3) No group-based discrimination on basis of
genetic information
(A) In general
For purposes of this section, a group
health plan, and health 1 insurance issuer of1 So

in original. Probably should be preceded by ‘‘a’’.

§ 300gg–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fering group health insurance coverage in
connection with a group health plan, may
not adjust premium or contribution amounts
for the group covered under such plan on the
basis of genetic information.
(B) Rule of construction
Nothing in subparagraph (A) or in paragraphs (1) and (2) of subsection (d) shall be
construed to limit the ability of a health insurance issuer offering group or individual
health insurance coverage to increase the
premium for an employer based on the manifestation of a disease or disorder of an individual who is enrolled in the plan. In such
case, the manifestation of a disease or disorder in one individual cannot also be used
as genetic information about other group
members and to further increase the premium for the employer.
(c) Genetic testing
(1) Limitation on requesting or requiring genetic testing
A group health plan, and a health insurance
issuer offering health insurance coverage in
connection with a group health plan, shall not
request or require an individual or a family
member of such individual to undergo a genetic test.
(2) Rule of construction
Paragraph (1) shall not be construed to limit
the authority of a health care professional
who is providing health care services to an individual to request that such individual undergo a genetic test.
(3) Rule of construction regarding payment
(A) In general
Nothing in paragraph (1) shall be construed to preclude a group health plan, or a
health insurance issuer offering health insurance coverage in connection with a group
health plan, from obtaining and using the results of a genetic test in making a determination regarding payment (as such term
is defined for the purposes of applying the
regulations promulgated by the Secretary
under part C of title XI of the Social Security Act [42 U.S.C. 1320d et seq.] and section
264 of the Health Insurance Portability and
Accountability Act of 1996, as may be revised
from time to time) consistent with subsection (a).
(B) Limitation
For purposes of subparagraph (A), a group
health plan, or a health insurance issuer offering health insurance coverage in connection with a group health plan, may request
only the minimum amount of information
necessary to accomplish the intended purpose.
(4) Research exception
Notwithstanding paragraph (1), a group
health plan, or a health insurance issuer offering health insurance coverage in connection
with a group health plan, may request, but not
require, that a participant or beneficiary undergo a genetic test if each of the following
conditions is met:

Page 1296

(A) The request is made pursuant to research that complies with part 46 of title 45,
Code of Federal Regulations, or equivalent
Federal regulations, and any applicable
State or local law or regulations for the protection of human subjects in research.
(B) The plan or issuer clearly indicates to
each participant or beneficiary, or in the
case of a minor child, to the legal guardian
of such beneficiary, to whom the request is
made that—
(i) compliance with the request is voluntary; and
(ii) non-compliance will have no effect
on enrollment status or premium or contribution amounts.
(C) No genetic information collected or acquired under this paragraph shall be used for
underwriting purposes.
(D) The plan or issuer notifies the Secretary in writing that the plan or issuer is
conducting activities pursuant to the exception provided for under this paragraph, including a description of the activities conducted.
(E) The plan or issuer complies with such
other conditions as the Secretary may by
regulation require for activities conducted
under this paragraph.
(d) Prohibition on collection of genetic information
(1) In general
A group health plan, and a health insurance
issuer offering health insurance coverage in
connection with a group health plan, shall not
request, require, or purchase genetic information for underwriting purposes (as defined in
section 300gg–91 of this title).
(2) Prohibition on collection of genetic information prior to enrollment
A group health plan, and a health insurance
issuer offering health insurance coverage in
connection with a group health plan, shall not
request, require, or purchase genetic information with respect to any individual prior to
such individual’s enrollment under the plan or
coverage in connection with such enrollment.
(3) Incidental collection
If a group health plan, or a health insurance
issuer offering health insurance coverage in
connection with a group health plan, obtains
genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request,
requirement, or purchase shall not be considered a violation of paragraph (2) if such request, requirement, or purchase is not in violation of paragraph (1).
(e) Application to all plans
The provisions of subsections (a)(6), (b)(3), (c),
and (d) and subsection (b)(1) and section 300gg–3
of this title with respect to genetic information,
shall apply to group health plans and health insurance issuers without regard to section
300gg–21(a) 2 of this title.
2 See

References in Text note below.

Page 1297

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Genetic information of a fetus or embryo
Any reference in this part to genetic information concerning an individual or family member
of an individual shall—
(1) with respect to such an individual or family member of an individual who is a pregnant
woman, include genetic information of any
fetus carried by such pregnant woman; and
(2) with respect to an individual or family
member utilizing an assisted reproductive
technology, include genetic information of
any embryo legally held by the individual or
family member.
(j) 3 Programs of health promotion or disease
prevention
(1) General provisions
(A) General rule
For purposes of subsection (b)(2)(B), a program of health promotion or disease prevention (referred to in this subsection as a
‘‘wellness program’’) shall be a program offered by an employer that is designed to promote health or prevent disease that meets
the applicable requirements of this subsection.
(B) No conditions based on health status factor
If none of the conditions for obtaining a
premium discount or rebate or other reward
for participation in a wellness program is
based on an individual satisfying a standard
that is related to a health status factor,
such wellness program shall not violate this
section if participation in the program is
made available to all similarly situated individuals and the requirements of paragraph
(2) are complied with.
(C) Conditions based on health status factor
If any of the conditions for obtaining a
premium discount or rebate or other reward
for participation in a wellness program is
based on an individual satisfying a standard
that is related to a health status factor,
such wellness program shall not violate this
section if the requirements of paragraph (3)
are complied with.
(2) Wellness programs not subject to requirements
If none of the conditions for obtaining a premium discount or rebate or other reward
under a wellness program as described in paragraph (1)(B) are based on an individual satisfying a standard that is related to a health
status factor (or if such a wellness program
does not provide such a reward), the wellness
program shall not violate this section if participation in the program is made available to
all similarly situated individuals. The following programs shall not have to comply with
the requirements of paragraph (3) if participation in the program is made available to all
similarly situated individuals:
(A) A program that reimburses all or part
of the cost for memberships in a fitness center.
3 So

in original. No subsecs. (g) to (i) have been enacted.

§ 300gg–4

(B) A diagnostic testing program that provides a reward for participation and does not
base any part of the reward on outcomes.
(C) A program that encourages preventive
care related to a health condition through
the waiver of the copayment or deductible
requirement under group 1 health plan for
the costs of certain items or services related
to a health condition (such as prenatal care
or well-baby visits).
(D) A program that reimburses individuals
for the costs of smoking cessation programs
without regard to whether the individual
quits smoking.
(E) A program that provides a reward to
individuals for attending a periodic health
education seminar.
(3) Wellness programs subject to requirements
If any of the conditions for obtaining a premium discount, rebate, or reward under a
wellness program as described in paragraph
(1)(C) is based on an individual satisfying a
standard that is related to a health status factor, the wellness program shall not violate
this section if the following requirements are
complied with:
(A) The reward for the wellness program,
together with the reward for other wellness
programs with respect to the plan that requires satisfaction of a standard related to a
health status factor, shall not exceed 30 percent of the cost of employee-only coverage
under the plan. If, in addition to employees
or individuals, any class of dependents (such
as spouses or spouses and dependent children) may participate fully in the wellness
program, such reward shall not exceed 30
percent of the cost of the coverage in which
an employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of coverage shall be determined based on the total amount of employer and employee contributions for the
benefit package under which the employee is
(or the employee and any dependents are) receiving coverage. A reward may be in the
form of a discount or rebate of a premium or
contribution, a waiver of all or part of a
cost-sharing mechanism (such as deductibles, copayments, or coinsurance), the absence of a surcharge, or the value of a benefit that would otherwise not be provided
under the plan. The Secretaries of Labor,
Health and Human Services, and the Treasury may increase the reward available under
this subparagraph to up to 50 percent of the
cost of coverage if the Secretaries determine
that such an increase is appropriate.
(B) The wellness program shall be reasonably designed to promote health or prevent
disease. A program complies with the preceding sentence if the program has a reasonable chance of improving the health of, or
preventing disease in, participating individuals and it is not overly burdensome, is not
a subterfuge for discriminating based on a
health status factor, and is not highly suspect in the method chosen to promote health
or prevent disease.
(C) The plan shall give individuals eligible
for the program the opportunity to qualify

§ 300gg–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

for the reward under the program at least
once each year.
(D) The full reward under the wellness program shall be made available to all similarly
situated individuals. For such purpose,
among other things:
(i) The reward is not available to all
similarly situated individuals for a period
unless the wellness program allows—
(I) for a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward
for any individual for whom, for that period, it is unreasonably difficult due to a
medical condition to satisfy the otherwise applicable standard; and
(II) for a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward
for any individual for whom, for that period, it is medically inadvisable to attempt to satisfy the otherwise applicable
standard.
(ii) If reasonable under the circumstances, the plan or issuer may seek verification, such as a statement from an individual’s physician, that a health status
factor makes it unreasonably difficult or
medically inadvisable for the individual to
satisfy or attempt to satisfy the otherwise
applicable standard.
(E) The plan or issuer involved shall disclose in all plan materials describing the
terms of the wellness program the availability of a reasonable alternative standard (or
the possibility of waiver of the otherwise applicable standard) required under subparagraph (D). If plan materials disclose that
such a program is available, without describing its terms, the disclosure under this subparagraph shall not be required.
(k) Existing programs
Nothing in this section shall prohibit a program of health promotion or disease prevention
that was established prior to March 23, 2010, and
applied with all applicable regulations, and that
is operating on such date, from continuing to be
carried out for as long as such regulations remain in effect.
(l) Wellness program demonstration project
(1) In general
Not later than July 1, 2014, the Secretary, in
consultation with the Secretary of the Treasury and the Secretary of Labor, shall establish
a 10-State demonstration project under which
participating States shall apply the provisions
of subsection (j) to programs of health promotion offered by a health insurance issuer
that offers health insurance coverage in the
individual market in such State.
(2) Expansion of demonstration project
If the Secretary, in consultation with the
Secretary of the Treasury and the Secretary
of Labor, determines that the demonstration
project described in paragraph (1) is effective,
such Secretaries may, beginning on July 1,
2017 expand such demonstration project to include additional participating States.

Page 1298

(3) Requirements
(A) Maintenance of coverage
The Secretary, in consultation with the
Secretary of the Treasury and the Secretary
of Labor, shall not approve the participation
of a State in the demonstration project
under this section unless the Secretaries determine that the State’s project is designed
in a manner that—
(i) will not result in any decrease in coverage; and
(ii) will not increase the cost to the Federal Government in providing credits
under section 36B of title 26 or cost-sharing assistance under section 18071 of this
title.
(B) Other requirements
States that participate in the demonstration project under this subsection—
(i) may permit premium discounts or rebates or the modification of otherwise applicable copayments or deductibles for adherence to, or participation in, a reasonably designed program of health promotion and disease prevention;
(ii) shall ensure that requirements of
consumer protection are met in programs
of health promotion in the individual market;
(iii) shall require verification from
health insurance issuers that offer health
insurance coverage in the individual market of such State that premium discounts—
(I) do not create undue burdens for individuals insured in the individual market;
(II) do not lead to cost shifting; and
(III) are not a subterfuge for discrimination;
(iv) shall ensure that consumer data is
protected in accordance with the requirements of section 264(c) of the Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d–2 note); and
(v) shall ensure and demonstrate to the
satisfaction of the Secretary that the discounts or other rewards provided under the
project reflect the expected level of participation in the wellness program involved and the anticipated effect the program will have on utilization or medical
claim costs.
(m) Report
(1) In general
Not later than 3 years after March 23, 2010,
the Secretary, in consultation with the Secretary of the Treasury and the Secretary of
Labor, shall submit a report to the appropriate committees of Congress concerning—
(A) the effectiveness of wellness programs
(as defined in subsection (j)) in promoting
health and preventing disease;
(B) the impact of such wellness programs
on the access to care and affordability of
coverage for participants and non-participants of such programs;
(C) the impact of premium-based and costsharing incentives on participant behavior

Page 1299

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and the role of such programs in changing
behavior; and
(D) the effectiveness of different types of
rewards.
(2) Data collection
In preparing the report described in paragraph (1), the Secretaries shall gather relevant
information from employers who provide employees with access to wellness programs, including State and Federal agencies.
(n) Regulations
Nothing in this section shall be construed as
prohibiting the Secretaries of Labor, Health and
Human Services, or the Treasury from promulgating regulations in connection with this section.
(July 1, 1944, ch. 373, title XXVII, § 2705, as added
and amended Pub. L. 111–148, title I, § 1201(3), (4),
Mar. 23, 2010, 124 Stat. 154, 156.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(c)(3)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Part
C of title XI of the Act is classified generally to part
C (§ 1320d et seq.) of subchapter XI of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
Section 264 of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsecs.
(c)(3)(A) and (l)(3)(B)(iv), is section 264 of Pub. L.
104–191, which is set out as a note under section 1320d–2
of this title.
Section 300gg–21(a) of this title, referred to in subsec.
(e), was in the original a reference to section 2735(a) of
act July 1, 1944, and was translated as if it referred to
section 2722(a) of that act to reflect the probable intent
of Congress because of the renumbering of section 2735
as 2722 by Pub. L. 111–148, title I, § 1563(c)(12)(D), formerly § 1562(c)(12)(D), title X, § 10107(b)(1), Mar. 23, 2010,
124 Stat. 269, 911. The act July 1, 1944, does not contain
a section 2735.
CODIFICATION
The text of section 300gg–1 of this title, which was
amended and transferred to subsecs. (b) to (f) of this
section by Pub. L. 111–148, § 1201(3), was based on act
July 1, 1944, ch. 373, title XXVII, § 2702, as added Pub. L.
104–191, title I, § 102(a), Aug. 21, 1996, 110 Stat. 1961;
amended Pub. L. 110–233, title I, § 102(a)(1)–(3), May 21,
2008, 122 Stat. 888, 890. For text of section 300gg–1 prior
to amendment and transfer by Pub. L. 111–148, see Prior
Provisions note under section 300gg–1 of this title.
PRIOR PROVISIONS
A prior section 300gg–4, act July 1, 1944, ch. 373, title
XXVII, § 2704, as added Pub. L. 104–204, title VI,
§ 604(a)(3), Sept. 26, 1996, 110 Stat. 2939, which related to
standards relating to benefits for mothers and newborns, was renumbered section 2725 of act July 1, 1944,
by Pub. L. 111–148, title I, § 1001(2), Mar. 23, 2010, 124
Stat. 130, and transferred to section 300gg–25 of this
title.
A prior section 2705 of act July 1, 1944, was renumbered section 2726 and is classified to section 300gg–26 of
this title.
Another prior section 2705 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238d of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 1201(3), transferred section
300gg–1 of this title to subsecs. (d) to (f) of this section

§ 300gg–5

after amending it by striking out the section catchline
‘‘Prohibiting discrimination against individual participants and beneficiaries based on health status’’, by
striking subsec. (a) which prohibited discrimination
against individual participants in group health plans
based on certain health status-related factors, by
amending subsec. (b) by substituting ‘‘health insurance
issuer offering group or individual health insurance
coverage’’ for ‘‘health insurance issuer offering health
insurance coverage in connection with a group health
plan’’ in pars. (1) and (3)(B) and by inserting ‘‘or individual’’ after ‘‘employer’’ and ‘‘or individual health
coverage, as the case may be’’ before semicolon in par.
(2)(A), and by amending subsec. (e) by substituting
‘‘(a)(6)’’ for ‘‘(a)(1)(F)’’ and ‘‘300gg–3’’ for ‘‘300gg’’ and
making technical amendment to reference in original
act which appears in text as reference to section
300gg–21(a) of this title.
EFFECTIVE DATE
Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

§ 300gg–5. Non-discrimination in health care
(a) Providers
A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is
acting within the scope of that provider’s license or certification under applicable State
law. This section shall not require that a group
health plan or health insurance issuer contract
with any health care provider willing to abide
by the terms and conditions for participation established by the plan or issuer. Nothing in this
section shall be construed as preventing a group
health plan, a health insurance issuer, or the
Secretary from establishing varying reimbursement rates based on quality or performance
measures.
(b) Individuals
The provisions of section 218c 1 of title 29 (relating to non-discrimination) shall apply with
respect to a group health plan or health insurance issuer offering group or individual health
insurance coverage.
(July 1, 1944, ch. 373, title XXVII, § 2706, as added
Pub. L. 111–148, title I, § 1201(4), Mar. 23, 2010, 124
Stat. 160.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
REFERENCES IN TEXT
Section 218c of title 29, referred to in subsec. (b), was
in the original ‘‘section 1558 of the Patient Protection
and Affordable Care Act’’, meaning section 1558 of Pub.
L. 111–148, and was translated as meaning section 18C of
act June 25, 1938, ch. 676, which was added by section
1558 of Pub. L. 111–148, to reflect the probable intent of
Congress.
PRIOR PROVISIONS
A prior section 300gg–5, act July 1, 1944, ch. 373, title
XXVII, § 2705, as added Pub. L. 104–204, title VII, § 703(a),
Sept. 26, 1996, 110 Stat. 2947, and amended, which related to parity in mental health and substance use dis1 See

References in Text note below.

§ 300gg–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1300

order benefits, was renumbered section 2726 of act July
1, 1944, and transferred to section 300gg–26 of this title.
A prior section 2706 of act July 1, 1944, was renumbered section 2727 and is classified to section 300gg–27 of
this title.
Another prior section 2706 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238e of this title.

A prior section 2707 of act July 1, 1944, was renumbered section 2728 and is classified to section 300gg–28 of
this title.
Another prior section 2707 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238f of this title.

EFFECTIVE DATE

Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

§ 300gg–6. Comprehensive health insurance coverage
(a) Coverage for essential health benefits package
A health insurance issuer that offers health
insurance coverage in the individual or small
group market shall ensure that such coverage
includes the essential health benefits package
required under section 18022(a) of this title.
(b) Cost-sharing under group health plans
A group health plan shall ensure that any annual cost-sharing imposed under the plan does
not exceed the limitations provided for under
paragraphs (1) and (2) of section 18022(c) 1 of this
title.
(c) Child-only plans
If a health insurance issuer offers health insurance coverage in any level of coverage specified under section 18022(d) of this title, the issuer shall also offer such coverage in that level
as a plan in which the only enrollees are individuals who, as of the beginning of a plan year,
have not attained the age of 21.
(d) Dental only
This section shall not apply to a plan described in section 18031(d)(2)(B)(ii) 1 of this title.

EFFECTIVE DATE

§ 300gg–7. Prohibition on excessive waiting periods
A group health plan and a health insurance issuer offering group health insurance coverage
shall not apply any waiting period (as defined in
section 300gg–3(b)(4) of this title) that exceeds 90
days.
(July 1, 1944, ch. 373, title XXVII, § 2708, as added
and amended Pub. L. 111–148, title I, § 1201(4),
title X, § 10103(b), Mar. 23, 2010, 124 Stat. 161, 892.)
ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.
PRIOR PROVISIONS
A prior section 300gg–7, act July 1, 1944, ch. 373, title
XXVII, § 2707, as added Pub. L. 110–381, § 2(b)(1), Oct. 9,
2008, 122 Stat. 4083, which related to coverage of dependent students on medically necessary leave of absence,
was renumbered section 2728 of act July 1, 1944, and
transferred to section 300gg–28 of this title.
A prior section 2708 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238g of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 10103(b), struck out ‘‘or individual’’ after ‘‘offering group’’.
EFFECTIVE DATE

(July 1, 1944, ch. 373, title XXVII, § 2707, as added
Pub. L. 111–148, title I, § 1201(4), Mar. 23, 2010, 124
Stat. 161.)

Section effective for plan years beginning on or after
Jan. 1, 2014, see section 1255 of Pub. L. 111–148, set out
as a note under section 300gg of this title.

ENACTMENT OF SECTION
For delayed effective date of section, see Effective Date note below.

§ 300gg–8. Coverage for individuals participating
in approved clinical trials

REFERENCES IN TEXT
Section 18022(c) of this title, referred to in subsec. (b),
was in the original ‘‘section 1302(c)’’, and was translated as meaning section 1302(c) of Pub. L. 111–148, pars.
(1) and (2) of which relate to annual limitations on
cost-sharing and deductibles, to reflect the probable intent of Congress.
Section 18031(d)(2)(B)(ii) of this title, referred to in
subsec.
(d),
was
in
the
original
‘‘section
1302(d)(2)(B)(ii)(I)’’, and was translated as meaning section 1311(d)(2)(B)(ii) of Pub. L. 111–148, which relates to
offering of stand-alone dental benefits, to reflect the
probable intent of Congress.
PRIOR PROVISIONS
A prior section 300gg–6, act July 1, 1944, ch. 373, title
XXVII, § 2706, as added Pub. L. 105–277, div. A, § 101(f)
[title IX, § 903(a)], Oct. 21, 1998, 112 Stat. 2681–337,
2681–438, which related to required coverage for reconstructive surgery following mastectomies, was renumbered section 2727 of act July 1, 1944, and transferred to
section 300gg–27 of this title.
1 See

References in Text note below.

(a) Coverage
(1) In general
If a group health plan or a health insurance
issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer—
(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);
(B) subject to subsection (c), may not deny
(or limit or impose additional conditions on)
the coverage of routine patient costs for
items and services furnished in connection
with participation in the trial; and
(C) may not discriminate against the individual on the basis of the individual’s participation in such trial.
(2) Routine patient costs
(A) Inclusion
For purposes of paragraph (1)(B), subject
to subparagraph (B), routine patient costs
include all items and services consistent

Page 1301

TITLE 42—THE PUBLIC HEALTH AND WELFARE

with the coverage provided in the plan (or
coverage) that is typically covered for a
qualified individual who is not enrolled in a
clinical trial.
(B) Exclusion
For purposes of paragraph (1)(B), routine
patient costs does not include—
(i) the investigational item, device, or
service, itself;
(ii) items and services that are provided
solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;
or
(iii) a service that is clearly inconsistent
with widely accepted and established
standards of care for a particular diagnosis.
(3) Use of in-network providers
If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a
plan or issuer from requiring that a qualified
individual participate in the trial through
such a participating provider if the provider
will accept the individual as a participant in
the trial.
(4) Use of out-of-network
Notwithstanding paragraph (3), paragraph (1)
shall apply to a qualified individual participating in an approved clinical trial that is
conducted outside the State in which the
qualified individual resides.
(b) Qualified individual defined
For purposes of subsection (a), the term
‘‘qualified individual’’ means an individual who
is a participant or beneficiary in a health plan
or with coverage described in subsection (a)(1)
and who meets the following conditions:
(1) The individual is eligible to participate
in an approved clinical trial according to the
trial protocol with respect to treatment of
cancer or other life-threatening disease or
condition.
(2) Either—
(A) the referring health care professional
is a participating health care provider and
has concluded that the individual’s participation in such trial would be appropriate
based upon the individual meeting the conditions described in paragraph (1); or
(B) the participant or beneficiary provides
medical and scientific information establishing that the individual’s participation in
such trial would be appropriate based upon
the individual meeting the conditions described in paragraph (1).
(c) Limitations on coverage
This section shall not be construed to require
a group health plan, or a health insurance issuer
offering group or individual health insurance
coverage, to provide benefits for routine patient
care services provided outside of the plan’s (or
coverage’s) health care provider network unless
out-of-network benefits are otherwise provided
under the plan (or coverage).

§ 300gg–8

(d) Approved clinical trial defined
(1) In general
In this section, the term ‘‘approved clinical
trial’’ means a phase I, phase II, phase III, or
phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition and is described in any of the
following subparagraphs:
(A) FEDERALLY FUNDED TRIALS.—The study
or investigation is approved or funded
(which may include funding through in-kind
contributions) by one or more of the following:
(i) The National Institutes of Health.
(ii) The Centers for Disease Control and
Prevention.
(iii) The Agency for Health Care Research and Quality.
(iv) The Centers for Medicare & Medicaid
Services.
(v) cooperative 1 group or center of any
of the entities described in clauses (i)
through (iv) or the Department of Defense
or the Department of Veterans Affairs.
(vi) A qualified non-governmental research entity identified in the guidelines
issued by the National Institutes of Health
for center support grants.
(vii) Any of the following if the conditions described in paragraph (2) are met:
(I) The Department of Veterans Affairs.
(II) The Department of Defense.
(III) The Department of Energy.
(B) The study or investigation is conducted under an investigational new drug
application reviewed by the Food and Drug
Administration.
(C) The study or investigation is a drug
trial that is exempt from having such an investigational new drug application.
(2) Conditions for departments
The conditions described in this paragraph,
for a study or investigation conducted by a
Department, are that the study or investigation has been reviewed and approved through a
system of peer review that the Secretary determines—
(A) to be comparable to the system of peer
review of studies and investigations used by
the National Institutes of Health, and
(B) assures unbiased review of the highest
scientific standards by qualified individuals
who have no interest in the outcome of the
review.
(e) Life-threatening condition defined
In this section, the term ‘‘life-threatening
condition’’ means any disease or condition from
which the likelihood of death is probable unless
the course of the disease or condition is interrupted.
(f) Construction
Nothing in this section shall be construed to
limit a plan’s or issuer’s coverage with respect
to clinical trials.
1 So

in original. Probably should be preceded by ‘‘A’’.

§ 300gg–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(g) Application to FEHBP
Notwithstanding any provision of chapter 89 of
title 5, this section shall apply to health plans
offered under the program under such chapter.
(h) Preemption
Notwithstanding any other provision of this
chapter, nothing in this section shall preempt
State laws that require a clinical trials policy
for State regulated health insurance plans that
is in addition to the policy required under this
section.
(July 1, 1944, ch. 373, title XXVII, § 2709, as added
Pub. L. 111–148, title X, § 10103(c), Mar. 23, 2010,
124 Stat. 892.)
CODIFICATION
Another section 2709 of act July 1, 1944, is classified
to section 300gg–9 of this title.

Page 1302

and trade secret information under applicable
law.
(July 1, 1944, ch. 373, title XXVII, § 2709, formerly
§ 2713, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1966; renumbered § 2733,
renumbered § 2709, and amended Pub. L. 111–148,
title I, §§ 1001(3), 1563(c)(10), formerly § 1562(c)(10),
title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 130,
268, 911.)
CODIFICATION
Section was formerly classified to section 300gg–13 of
this title prior to renumbering by Pub. L. 111–148.
Another section 2709 of act July 1, 1944, is classified
to section 300gg–8 of this title.
PRIOR PROVISIONS
A prior section 2709 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238h of this title.

PRIOR PROVISIONS

AMENDMENTS

A prior section 2709 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238h of this title.

2010—Subsec. (a). Pub. L. 111–148, § 1563(c)(10)(A), formerly § 1562(c)(10)(A), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), in introductory provisions substituted
‘‘small employer or an individual’’ for ‘‘small employer’’, in par. (1) inserted ‘‘, or individual, as applicable,’’ after ‘‘employer’’, and in par. (2) substituted ‘‘employer, or individual, as applicable,’’ for ‘‘small employer’’.
Subsec. (b)(1). Pub. L. 111–148, § 1563(c)(10)(B)(i), formerly § 1562(c)(10)(B)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), in introductory provisions substituted ‘‘employer, or individual, as applicable,’’ for
‘‘small employer’’, in subpar. (A), inserted ‘‘and’’ at
end, struck out subpars. (B) and (C) which related to
provisions of coverage relating to renewability of coverage and preexisting condition exclusions, respectively, in subpar. (D), inserted ‘‘, or individual, as applicable,’’ after ‘‘employer’’, and redesignated subpar.
(D) as (B).
Subsec. (b)(2). Pub. L. 111–148, § 1563(c)(10)(B)(ii), formerly § 1562(c)(10)(B)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘employer, or individual, as applicable,’’ for ‘‘small employer’’ and ‘‘employers, or individuals, as applicable,’’ for ‘‘small employers’’ in two places.

§ 300gg–9. Disclosure of information
(a) Disclosure of information by health plan issuers
In connection with the offering of any health
insurance coverage to a small employer or an individual, a health insurance issuer—
(1) shall make a reasonable disclosure to
such employer, or individual, as applicable,,1
as part of its solicitation and sales materials,
of the availability of information described in
subsection (b) of this section, and
(2) upon request of such a 2 employer, or individual, as applicable,,1 provide such information.
(b) Information described
(1) In general
Subject to paragraph (3), with respect to a
health insurance issuer offering health insurance coverage to a 2 employer, or individual, as
applicable,,1 information described in this subsection is information concerning—
(A) the provisions of such coverage concerning issuer’s right to change premium
rates and the factors that may affect
changes in premium rates; and
(B) the benefits and premiums available
under all health insurance coverage for
which the employer, or individual, as applicable, is qualified.
(2) Form of information
Information under this subsection shall be
provided to employers, or individuals, as applicable, in a manner determined to be understandable by the average employer, or individual, as applicable,,1 and shall be sufficient to
reasonably inform employers, or individuals,
as applicable, of their rights and obligations
under the health insurance coverage.
(3) Exception
An issuer is not required under this section
to disclose any information that is proprietary
1 So
2 So

in original.
in original. Probably should be ‘‘an’’.

EFFECTIVE DATE
Section applicable with respect to group health
plans, and health insurance coverage offered in connection with group health plans, for plan years beginning
after June 30, 1997, except as otherwise provided, see
section 102(c) of Pub. L. 104–191, set out as a note under
section 300gg of this title.
SUBPART II—IMPROVING COVERAGE

A prior subpart 2, consisting of sections 300gg–4 to
300gg–7, related to other requirements, prior to repeal
of the subpart designation and heading and transfer of
sections 300gg–4 to 300gg–7 to 300gg–25 to 300gg–28, respectively, of this title by Pub. L. 111–148, title I,
§§ 1001(2), 1563(c)(2), formerly § 1562(c)(2), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 911.
Another prior subpart 2, consisting of sections
300gg–11 to 300gg–13, related to provisions applicable
only to health insurance issuers, was redesignated subpart 3 of this part by Pub. L. 104–204, title VI, § 604(a)(2),
Sept. 26, 1996, 110 Stat. 2939.
A prior subpart 3, consisting of sections 300gg–11 to
300gg–13, related to provisions applicable only to health
insurance issuers, prior to repeal of the subpart designation and heading by Pub. L. 111–148, title I,
§ 1563(c)(7), formerly § 1562(c)(7), title X, § 10107(b)(1),
Mar. 23, 2010, 124 Stat. 266, 911.
A prior subpart 4, consisting of sections 300gg–21 to
300gg–23, which related to exclusion of plans, enforce-

Page 1303

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ment, and preemption, was redesignated subpart 2 of
this part by Pub. L. 111–148, title I, § 1563(c)(11), formerly § 1562(c)(11), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 268, 911.

§ 300gg–11. No lifetime or annual limits
(a) Prohibition
(1) In general
A group health plan and a health insurance
issuer offering group or individual health insurance coverage may not establish—
(A) lifetime limits on the dollar value of
benefits for any participant or beneficiary;
or
(B) except as provided in paragraph (2), annual limits on the dollar value of benefits
for any participant or beneficiary.
(2) Annual limits prior to 2014
With respect to plan years beginning prior
to January 1, 2014, a group health plan and a
health insurance issuer offering group or individual health insurance coverage may only establish a restricted annual limit on the dollar
value of benefits for any participant or beneficiary with respect to the scope of benefits
that are essential health benefits under section 18022(b) of this title, as determined by the
Secretary. In defining the term ‘‘restricted annual limit’’ for purposes of the preceding sentence, the Secretary shall ensure that access
to needed services is made available with a
minimal impact on premiums.
(b) Per beneficiary limits
Subsection (a) shall not be construed to prevent a group health plan or health insurance
coverage from placing annual or lifetime per
beneficiary limits on specific covered benefits
that are not essential health benefits under section 18022(b) of this title, to the extent that such
limits are otherwise permitted under Federal or
State law.
(July 1, 1944, ch. 373, title XXVII, § 2711, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(a), Mar. 23, 2010, 124 Stat. 131, 883.)
PRIOR PROVISIONS
A prior section 300gg–11, act July 1, 1944, ch. 373, title
XXVII, § 2711, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1962, was renumbered section
2731 of act July 1, 1944, amended, and transferred to
subsecs. (c) and (d) of section 300gg–1 of this title, by
Pub. L. 111–148, title I, §§ 1001(3), 1563(c)(8), formerly
§ 1562(c)(8), title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat.
130, 266, 911. Prior to amendment and transfer by Pub.
L. 111–148, text of section 300gg–11 read as follows:
‘‘(a) ISSUANCE OF COVERAGE IN THE SMALL GROUP
MARKET.—
‘‘(1) IN GENERAL.—Subject to subsections (c)
through (f), each health insurance issuer that offers
health insurance coverage in the small group market
in a State—
‘‘(A) must accept every small employer (as defined in section 300gg–91(e)(4) of this title) in the
State that applies for such coverage; and
‘‘(B) must accept for enrollment under such coverage every eligible individual (as defined in paragraph (2)) who applies for enrollment during the period in which the individual first becomes eligible
to enroll under the terms of the group health plan
and may not place any restriction which is inconsistent with section 300gg–1 of this title on an eligible individual being a participant or beneficiary.

§ 300gg–11

‘‘(2) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of
this section, the term ‘eligible individual’ means,
with respect to a health insurance issuer that offers
health insurance coverage to a small employer in
connection with a group health plan in the small
group market, such an individual in relation to the
employer as shall be determined—
‘‘(A) in accordance with the terms of such plan,
‘‘(B) as provided by the issuer under rules of the
issuer which are uniformly applicable in a State to
small employers in the small group market, and
‘‘(C) in accordance with all applicable State laws
governing such issuer and such market.
‘‘(b) ASSURING ACCESS IN THE LARGE GROUP MARKET.—
‘‘(1) REPORTS TO HHS.—The Secretary shall request
that the chief executive officer of each State submit
to the Secretary, by not later December 31, 2000, and
every 3 years thereafter a report on—
‘‘(A) the access of large employers to health insurance coverage in the State, and
‘‘(B) the circumstances for lack of access (if any)
of large employers (or one or more classes of such
employers) in the State to such coverage.
‘‘(2) TRIENNIAL REPORTS TO CONGRESS.—The Secretary, based on the reports submitted under paragraph (1) and such other information as the Secretary
may use, shall prepare and submit to Congress, every
3 years, a report describing the extent to which large
employers (and classes of such employers) that seek
health insurance coverage in the different States are
able to obtain access to such coverage. Such report
shall include such recommendations as the Secretary
determines to be appropriate.
‘‘(3) GAO REPORT ON LARGE EMPLOYER ACCESS TO
HEALTH INSURANCE COVERAGE.—The Comptroller General shall provide for a study of the extent to which
classes of large employers in the different States are
able to obtain access to health insurance coverage
and the circumstances for lack of access (if any) to
such coverage. The Comptroller General shall submit
to Congress a report on such study not later than 18
months after August 21, 1996.
‘‘(c) SPECIAL RULES FOR NETWORK PLANS.—
‘‘(1) IN GENERAL.—In the case of a health insurance
issuer that offers health insurance coverage in the
small group market through a network plan, the issuer may—
‘‘(A) limit the employers that may apply for such
coverage to those with eligible individuals who live,
work, or reside in the service area for such network
plan; and
‘‘(B) within the service area of such plan, deny
such coverage to such employers if the issuer has
demonstrated, if required, to the applicable State
authority that—
‘‘(i) it will not have the capacity to deliver services adequately to enrollees of any additional
groups because of its obligations to existing
group contract holders and enrollees, and
‘‘(ii) it is applying this paragraph uniformly to
all employers without regard to the claims experience of those employers and their employees
(and their dependents) or any health status-related factor relating to such employees and dependents.
‘‘(2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—An issuer, upon denying health insurance
coverage in any service area in accordance with paragraph (1)(B), may not offer coverage in the small
group market within such service area for a period of
180 days after the date such coverage is denied.
‘‘(d) APPLICATION OF FINANCIAL CAPACITY LIMITS.—
‘‘(1) IN GENERAL.—A health insurance issuer may
deny health insurance coverage in the small group
market if the issuer has demonstrated, if required, to
the applicable State authority that—
‘‘(A) it does not have the financial reserves necessary to underwrite additional coverage; and
‘‘(B) it is applying this paragraph uniformly to all
employers in the small group market in the State

§ 300gg–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

consistent with applicable State law and without
regard to the claims experience of those employers
and their employees (and their dependents) or any
health status-related factor relating to such employees and dependents.
‘‘(2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—A health insurance issuer upon denying
health insurance coverage in connection with group
health plans in accordance with paragraph (1) in a
State may not offer coverage in connection with
group health plans in the small group market in the
State for a period of 180 days after the date such coverage is denied or until the issuer has demonstrated
to the applicable State authority, if required under
applicable State law, that the issuer has sufficient financial reserves to underwrite additional coverage,
whichever is later. An applicable State authority
may provide for the application of this subsection on
a service-area-specific basis.
‘‘(e) EXCEPTION TO REQUIREMENT FOR FAILURE TO
MEET CERTAIN MINIMUM PARTICIPATION OR CONTRIBUTION RULES.—
‘‘(1) IN GENERAL.—Subsection (a) shall not be construed to preclude a health insurance issuer from establishing employer contribution rules or group participation rules for the offering of health insurance
coverage in connection with a group health plan in
the small group market, as allowed under applicable
State law.
‘‘(2) RULES DEFINED.—For purposes of paragraph
(1)—
‘‘(A) the term ‘employer contribution rule’ means
a requirement relating to the minimum level or
amount of employer contribution toward the premium for enrollment of participants and beneficiaries; and
‘‘(B) the term ‘group participation rule’ means a
requirement relating to the minimum number of
participants or beneficiaries that must be enrolled
in relation to a specified percentage or number of
eligible individuals or employees of an employer.
‘‘(f) EXCEPTION FOR COVERAGE OFFERED ONLY TO BONA
FIDE ASSOCIATION MEMBERS.—Subsection (a) shall not
apply to health insurance coverage offered by a health
insurance issuer if such coverage is made available in
the small group market only through one or more bona
fide associations (as defined in section 300gg–91(d)(3) of
this title).’’
Another prior section 2711 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238j of this title.
AMENDMENTS
2010—Pub. L. 111–148, § 10101(a), amended section generally. Prior to amendment, text read as follows:
‘‘(a) IN GENERAL.—A group health plan and a health
insurance issuer offering group or individual health insurance coverage may not establish—
‘‘(1) lifetime limits on the dollar value of benefits
for any participant or beneficiary; or
‘‘(2) unreasonable annual limits (within the meaning of section 223 of title 26) on the dollar value of
benefits for any participant or beneficiary.
‘‘(b) PER BENEFICIARY LIMITS.—Subsection (a) shall
not be construed to prevent a group health plan or
health insurance coverage that is not required to provide essential health benefits under section 18022(b) of
this title from placing annual or lifetime per beneficiary limits on specific covered benefits to the extent
that such limits are otherwise permitted under Federal
or State law.’’
EFFECTIVE DATE
Pub. L. 111–148, title I, § 1004, Mar. 23, 2010, 124 Stat.
140, provided that:
‘‘(a) IN GENERAL.—Except as provided for in subsection (b), this subtitle [subtitle A (§§ 1001–1004) of title
I of Pub. L. 111–148, enacting this section and sections
300gg–12 to 300gg–15, 300gg–16 to 300gg–19, 300gg–93, and

Page 1304

300gg–94 of this title, amending former sections 300gg–11
and 300gg–12 of this title and sections 300gg–21 to
300gg–23 of this title, and transferring section 300gg–13
of this title to section 300gg–9 of this title and sections
300gg–4 to 300gg–7 of this title to sections 300gg–25 to
300gg–28 of this title, respectively] (and the amendments made by this subtitle) shall become effective for
plan years beginning on or after the date that is 6
months after the date of enactment of this Act [Mar.
23, 2010], except that the amendments made by sections
1002 and 1003 [enacting sections 300gg–93 and 300gg–94 of
this title] shall become effective for fiscal years beginning with fiscal year 2010.
‘‘(b) SPECIAL RULE.—The amendments made by sections 1002 and 1003 [enacting sections 300gg–93 and
300gg–94 of this title] shall take effect on the date of enactment of this Act [Mar. 23, 2010].’’

§ 300gg–12. Prohibition on rescissions
A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not rescind such plan or coverage with respect to an enrollee once the enrollee is covered under such plan or coverage involved, except that this section shall not apply
to a covered individual who has performed an
act or practice that constitutes fraud or makes
an intentional misrepresentation of material
fact as prohibited by the terms of the plan or
coverage. Such plan or coverage may not be cancelled except with prior notice to the enrollee,
and only as permitted under section 300gg–2(b) 1
or 300gg–42(b) of this title.
(July 1, 1944, ch. 373, title XXVII, § 2712, as added
Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124
Stat. 131.)
REFERENCES IN TEXT
Section 300gg–2(b) of this title, referred to in text,
was in the original a reference to section ‘‘2702(c)’’ of
act July 1, 1944, which was translated as meaning section 2703(b) of act July 1, 1944, to reflect the probable
intent of Congress. Section 2702(c), which is classified
to section 300gg–1 of this title, relates to special rules
for network plans, while section 2703(b) specifies the
reasons for which a health insurance issuer may
nonrenew or discontinue health insurance coverage offered in connection with a health insurance coverage
offering in the group or individual market. Section
300gg–2(b) also parallels section 300gg–42(b) which appears in the same context in this section as the reference to section 300gg–2(b).
PRIOR PROVISIONS
A prior section 300gg–12, act July 1, 1944, ch. 373, title
XXVII, § 2712, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1964, was renumbered section
2732 of act July 1, 1944, amended, and transferred to
subsecs. (b) to (e) of section 300gg–2 of this title, by
Pub. L. 111–148, title I, §§ 1001(3), 1563(c)(9), formerly
§ 1562(c)(9), title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat.
130, 267, 911. Prior to amendment and transfer, text of
section 300gg–12 read as follows:
‘‘(a) IN GENERAL.—Except as provided in this section,
if a health insurance issuer offers health insurance coverage in the small or large group market in connection
with a group health plan, the issuer must renew or continue in force such coverage at the option of the plan
sponsor of the plan.
‘‘(b) GENERAL EXCEPTIONS.—A health insurance issuer
may nonrenew or discontinue health insurance coverage offered in connection with a group health plan in
the small or large group market based only on one or
more of the following:
1 See

References in Text note below.

Page 1305

TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(1) NONPAYMENT OF PREMIUMS.—The plan sponsor
has failed to pay premiums or contributions in accordance with the terms of the health insurance coverage or the issuer has not received timely premium
payments.
‘‘(2) FRAUD.—The plan sponsor has performed an act
or practice that constitutes fraud or made an intentional misrepresentation of material fact under the
terms of the coverage.
‘‘(3) VIOLATION OF PARTICIPATION OR CONTRIBUTION
RULES.—The plan sponsor has failed to comply with a
material plan provision relating to employer contribution or group participation rules, as permitted
under section 300gg–11(e) of this title in the case of
the small group market or pursuant to applicable
State law in the case of the large group market.
‘‘(4) TERMINATION OF COVERAGE.—The issuer is ceasing to offer coverage in such market in accordance
with subsection (c) and applicable State law.
‘‘(5) MOVEMENT OUTSIDE SERVICE AREA.—In the case
of a health insurance issuer that offers health insurance coverage in the market through a network plan,
there is no longer any enrollee in connection with
such plan who lives, resides, or works in the service
area of the issuer (or in the area for which the issuer
is authorized to do business) and, in the case of the
small group market, the issuer would deny enrollment with respect to such plan under section
300gg–11(c)(1)(A) of this title.
‘‘(6) ASSOCIATION MEMBERSHIP CEASES.—In the case
of health insurance coverage that is made available
in the small or large group market (as the case may
be) only through one or more bona fide associations,
the membership of an employer in the association (on
the basis of which the coverage is provided) ceases
but only if such coverage is terminated under this
paragraph uniformly without regard to any health
status-related factor relating to any covered individual.
‘‘(c) REQUIREMENTS FOR UNIFORM TERMINATION OF
COVERAGE.—
‘‘(1) PARTICULAR TYPE OF COVERAGE NOT OFFERED.—
In any case in which an issuer decides to discontinue
offering a particular type of group health insurance
coverage offered in the small or large group market,
coverage of such type may be discontinued by the issuer in accordance with applicable State law in such
market only if—
‘‘(A) the issuer provides notice to each plan sponsor provided coverage of this type in such market
(and participants and beneficiaries covered under
such coverage) of such discontinuation at least 90
days prior to the date of the discontinuation of
such coverage;
‘‘(B) the issuer offers to each plan sponsor provided coverage of this type in such market, the option to purchase all (or, in the case of the large
group market, any) other health insurance coverage currently being offered by the issuer to a
group health plan in such market; and
‘‘(C) in exercising the option to discontinue coverage of this type and in offering the option of coverage under subparagraph (B), the issuer acts uniformly without regard to the claims experience of
those sponsors or any health status-related factor
relating to any participants or beneficiaries covered or new participants or beneficiaries who may
become eligible for such coverage.
‘‘(2) DISCONTINUANCE OF ALL COVERAGE.—
‘‘(A) IN GENERAL.—In any case in which a health
insurance issuer elects to discontinue offering all
health insurance coverage in the small group market or the large group market, or both markets, in
a State, health insurance coverage may be discontinued by the issuer only in accordance with applicable State law and if—
‘‘(i) the issuer provides notice to the applicable
State authority and to each plan sponsor (and
participants and beneficiaries covered under such
coverage) of such discontinuation at least 180

§ 300gg–13

days prior to the date of the discontinuation of
such coverage; and
‘‘(ii) all health insurance issued or delivered for
issuance in the State in such market (or markets)
are discontinued and coverage under such health
insurance coverage in such market (or markets)
is not renewed.
‘‘(B) PROHIBITION ON MARKET REENTRY.—In the
case of a discontinuation under subparagraph (A) in
a market, the issuer may not provide for the issuance of any health insurance coverage in the market and State involved during the 5-year period beginning on the date of the discontinuation of the
last health insurance coverage not so renewed.
‘‘(d) EXCEPTION FOR UNIFORM MODIFICATION OF COVERAGE.—At the time of coverage renewal, a health insurance issuer may modify the health insurance coverage for a product offered to a group health plan—
‘‘(1) in the large group market; or
‘‘(2) in the small group market if, for coverage that
is available in such market other than only through
one or more bona fide associations, such modification
is consistent with State law and effective on a uniform basis among group health plans with that product.
‘‘(e) APPLICATION TO COVERAGE OFFERED ONLY
THROUGH ASSOCIATIONS.—In applying this section in the
case of health insurance coverage that is made available by a health insurance issuer in the small or large
group market to employers only through one or more
associations, a reference to ‘plan sponsor’ is deemed,
with respect to coverage provided to an employer member of the association, to include a reference to such
employer.’’
Another prior section 2712 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238k of this title.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–13. Coverage of preventive health services
(a) In general
A group health plan and a health insurance issuer offering group or individual health insurance coverage shall, at a minimum provide coverage for and shall not impose any cost sharing
requirements for—
(1) evidence-based items or services that
have in effect a rating of ‘‘A’’ or ‘‘B’’ in the
current recommendations of the United States
Preventive Services Task Force;
(2) immunizations that have in effect a recommendation from the Advisory Committee
on Immunization Practices of the Centers for
Disease Control and Prevention with respect
to the individual involved; and 1
(3) with respect to infants, children, and adolescents, evidence-informed preventive care
and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration.2
(4) with respect to women, such additional
preventive care and screenings not described
in paragraph (1) as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of this paragraph.2
1 So
2 So

in original. The word ‘‘and’’ probably should not appear.
in original. The period probably should be a semicolon.

§ 300gg–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) for the purposes of this chapter, and for
the purposes of any other provision of law, the
current recommendations of the United States
Preventive Service Task Force regarding
breast cancer screening, mammography, and
prevention shall be considered the most current other than those issued in or around November 2009.
Nothing in this subsection shall be construed to
prohibit a plan or issuer from providing coverage for services in addition to those recommended by United States Preventive Services
Task Force or to deny coverage for services that
are not recommended by such Task Force.
(b) Interval
(1) In general
The Secretary shall establish a minimum interval between the date on which a recommendation described in subsection (a)(1) or
(a)(2) or a guideline under subsection (a)(3) is
issued and the plan year with respect to which
the requirement described in subsection (a) is
effective with respect to the service described
in such recommendation or guideline.
(2) Minimum
The interval described in paragraph (1) shall
not be less than 1 year.
(c) Value-based insurance design
The Secretary may develop guidelines to permit a group health plan and a health insurance
issuer offering group or individual health insurance coverage to utilize value-based insurance
designs.
(July 1, 1944, ch. 373, title XXVII, § 2713, as added
Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124
Stat. 131.)
PRIOR PROVISIONS
A prior section 300gg–13, act July 1, 1944, ch. 373, title
XXVII, § 2713, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1966, was renumbered section
2709 of act July 1, 1944, and transferred to section
300gg–9 of this title by Pub. L. 111–148, title I, §§ 1001(3),
1563(c)(10)(C),
formerly
§ 1562(c)(10)(C),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 268, 911.
Another prior section 2713 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238l of this title.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–14. Extension of dependent coverage
(a) In general
A group health plan and a health insurance issuer offering group or individual health insurance coverage that provides dependent coverage
of children shall continue to make such coverage available for an adult child until the child
turns 26 years of age. Nothing in this section
shall require a health plan or a health insurance
issuer described in the preceding sentence to
make coverage available for a child of a child receiving dependent coverage.
(b) Regulations
The Secretary shall promulgate regulations to
define the dependents to which coverage shall be
made available under subsection (a).

Page 1306

(c) Rule of construction
Nothing in this section shall be construed to
modify the definition of ‘‘dependent’’ as used in
title 26 with respect to the tax treatment of the
cost of coverage.
(July 1, 1944, ch. 373, title XXVII, § 2714, as added
Pub. L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124
Stat. 132; amended Pub. L. 111–152, title II,
§ 2301(b), Mar. 30, 2010, 124 Stat. 1082.)
PRIOR PROVISIONS
A prior section 2714 of act July 1, 1944, was successively renumbered by subsequent acts and transferred,
see section 238m of this title.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–152 struck out ‘‘(who is
not married)’’ after ‘‘adult child’’.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–15. Development and utilization of uniform explanation of coverage documents and
standardized definitions
(a) In general
Not later than 12 months after March 23, 2010,
the Secretary shall develop standards for use by
a group health plan and a health insurance issuer offering group or individual health insurance coverage, in compiling and providing to applicants, enrollees, and policyholders or certificate holders a summary of benefits and coverage
explanation that accurately describes the benefits and coverage under the applicable plan or
coverage. In developing such standards, the Secretary shall consult with the National Association of Insurance Commissioners (referred to in
this section as the ‘‘NAIC’’), a working group
composed of representatives of health insurancerelated
consumer
advocacy
organizations,
health insurance issuers, health care professionals, patient advocates including those representing individuals with limited English proficiency, and other qualified individuals.
(b) Requirements
The standards for the summary of benefits and
coverage developed under subsection (a) shall
provide for the following:
(1) Appearance
The standards shall ensure that the summary of benefits and coverage is presented in
a uniform format that does not exceed 4 pages
in length and does not include print smaller
than 12-point font.
(2) Language
The standards shall ensure that the summary is presented in a culturally and linguistically appropriate manner and utilizes terminology understandable by the average plan enrollee.
(3) Contents
The standards shall ensure that the summary of benefits and coverage includes—
(A) uniform definitions of standard insurance terms and medical terms (consistent

Page 1307

TITLE 42—THE PUBLIC HEALTH AND WELFARE

with subsection (g)) so that consumers may
compare health insurance coverage and understand the terms of coverage (or exception
to such coverage);
(B) a description of the coverage, including
cost sharing for—
(i) each of the categories of the essential
health benefits described in subparagraphs
(A) through (J) of section 18022(b)(1) of this
title; and
(ii) other benefits, as identified by the
Secretary;
(C) the exceptions, reductions, and limitations on coverage;
(D) the cost-sharing provisions, including
deductible, coinsurance, and co-payment obligations;
(E) the renewability and continuation of
coverage provisions;
(F) a coverage facts label that includes examples to illustrate common benefits scenarios, including pregnancy and serious or
chronic medical conditions and related cost
sharing, such scenarios to be based on recognized clinical practice guidelines;
(G) a statement of whether the plan or
coverage—
(i) provides minimum essential coverage
(as defined under section 5000A(f) of title
26); and
(ii) ensures that the plan or coverage
share of the total allowed costs of benefits
provided under the plan or coverage is not
less than 60 percent of such costs;
(H) a statement that the outline is a summary of the policy or certificate and that
the coverage document itself should be consulted to determine the governing contractual provisions; and
(I) a contact number for the consumer to
call with additional questions and an Internet web address where a copy of the actual
individual coverage policy or group certificate of coverage can be reviewed and obtained.
(c) Periodic review and updating
The Secretary shall periodically review and
update, as appropriate, the standards developed
under this section.
(d) Requirement to provide
(1) In general
Not later than 24 months after March 23,
2010, each entity described in paragraph (3)
shall provide, prior to any enrollment restriction, a summary of benefits and coverage explanation pursuant to the standards developed
by the Secretary under subsection (a) to—
(A) an applicant at the time of application;
(B) an enrollee prior to the time of enrollment or reenrollment, as applicable; and
(C) a policyholder or certificate holder at
the time of issuance of the policy or delivery
of the certificate.
(2) Compliance
An entity described in paragraph (3) is
deemed to be in compliance with this section
if the summary of benefits and coverage described in subsection (a) is provided in paper
or electronic form.

§ 300gg–15

(3) Entities in general
An entity described in this paragraph is—
(A) a health insurance issuer (including a
group health plan that is not a self-insured
plan) offering health insurance coverage
within the United States; or
(B) in the case of a self-insured group
health plan, the plan sponsor or designated
administrator of the plan (as such terms are
defined in section 1002(16) of title 29).
(4) Notice of modifications
If a group health plan or health insurance issuer makes any material modification in any
of the terms of the plan or coverage involved
(as defined for purposes of section 1022 of title
29) that is not reflected in the most recently
provided summary of benefits and coverage,
the plan or issuer shall provide notice of such
modification to enrollees not later than 60
days prior to the date on which such modification will become effective.
(e) Preemption
The standards developed under subsection (a)
shall preempt any related State standards that
require a summary of benefits and coverage that
provides less information to consumers than
that required to be provided under this section,
as determined by the Secretary.
(f) Failure to provide
An entity described in subsection (d)(3) that
willfully fails to provide the information required under this section shall be subject to a
fine of not more than $1,000 for each such failure. Such failure with respect to each enrollee
shall constitute a separate offense for purposes
of this subsection.
(g) Development of standard definitions
(1) In general
The Secretary shall, by regulation, provide
for the development of standards for the definitions of terms used in health insurance coverage, including the insurance-related terms
described in paragraph (2) and the medical
terms described in paragraph (3).
(2) Insurance-related terms
The insurance-related terms described in
this paragraph are premium, deductible, co-insurance, co-payment, out-of-pocket limit, preferred provider, non-preferred provider, out-ofnetwork co-payments, UCR (usual, customary
and reasonable) fees, excluded services, grievance and appeals, and such other terms as the
Secretary determines are important to define
so that consumers may compare health insurance coverage and understand the terms of
their coverage.
(3) Medical terms
The medical terms described in this paragraph are hospitalization, hospital outpatient
care, emergency room care, physician services,
prescription drug coverage, durable medical
equipment, home health care, skilled nursing
care, rehabilitation services, hospice services,
emergency medical transportation, and such
other terms as the Secretary determines are
important to define so that consumers may

§ 300gg–15a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

compare the medical benefits offered by
health insurance and understand the extent of
those medical benefits (or exceptions to those
benefits).
(July 1, 1944, ch. 373, title XXVII, § 2715, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(b), Mar. 23, 2010, 124 Stat. 132, 884.)
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 10101(b), substituted ‘‘and providing to applicants, enrollees, and
policyholders or certificate holders’’ for ‘‘and providing
to enrollees’’.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–15a. Provision of additional information
A group health plan and a health insurance issuer offering group or individual health insurance coverage shall comply with the provisions
of section 18031(e)(3) of this title, except that a
plan or coverage that is not offered through an
Exchange shall only be required to submit the
information required to the Secretary and the
State insurance commissioner, and make such
information available to the public.
(July 1, 1944, ch. 373, title XXVII, § 2715A, as
added Pub. L. 111–148, title X, § 10101(c), Mar. 23,
2010, 124 Stat. 884.)
§ 300gg–16. Prohibition on discrimination
favor of highly compensated individuals

in

(a) In general
A group health plan (other than a self-insured
plan) shall satisfy the requirements of section
105(h)(2) of title 26 (relating to prohibition on
discrimination in favor of highly compensated
individuals).
(b) Rules and definitions
For purposes of this section—
(1) Certain rules to apply
Rules similar to the rules contained in paragraphs (3), (4), and (8) of section 105(h) of title
26 shall apply.
(2) Highly compensated individual
The term ‘‘highly compensated individual’’
has the meaning given such term by section
105(h)(5) of title 26.
(July 1, 1944, ch. 373, title XXVII, § 2716, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(d), Mar. 23, 2010, 124 Stat. 135, 884.)
AMENDMENTS
2010—Pub. L. 111–148, § 10101(d), amended section generally. Prior to amendment, text read as follows:
‘‘(a) IN GENERAL.—The plan sponsor of a group health
plan (other than a self-insured plan) may not establish
rules relating to the health insurance coverage eligibility (including continued eligibility) of any full-time
employee under the terms of the plan that are based on
the total hourly or annual salary of the employee or
otherwise establish eligibility rules that have the effect of discriminating in favor of higher wage employees.
‘‘(b) LIMITATION.—Subsection (a) shall not be construed to prohibit a plan sponsor from establishing con-

Page 1308

tribution requirements for enrollment in the plan or
coverage that provide for the payment by employees
with lower hourly or annual compensation of a lower
dollar or percentage contribution than the payment required of similarly situated employees with a higher
hourly or annual compensation.’’
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–17. Ensuring the quality of care
(a) Quality reporting
(1) In general
Not later than 2 years after March 23, 2010,
the Secretary, in consultation with experts in
health care quality and stakeholders, shall develop reporting requirements for use by a
group health plan, and a health insurance issuer offering group or individual health insurance coverage, with respect to plan or coverage benefits and health care provider reimbursement structures that—
(A) improve health outcomes through the
implementation of activities such as quality
reporting, effective case management, care
coordination, chronic disease management,
and medication and care compliance initiatives, including through the use of the medical homes model as defined for purposes of
section 3602 1 of the Patient Protection and
Affordable Care Act, for treatment or services under the plan or coverage;
(B) implement activities to prevent hospital readmissions through a comprehensive
program for hospital discharge that includes
patient-centered education and counseling,
comprehensive discharge planning, and post
discharge reinforcement by an appropriate
health care professional;
(C) implement activities to improve patient safety and reduce medical errors
through the appropriate use of best clinical
practices, evidence based medicine, and
health information technology under the
plan or coverage; and
(D) implement wellness and health promotion activities.
(2) Reporting requirements
(A) In general
A group health plan and a health insurance issuer offering group or individual
health insurance coverage shall annually
submit to the Secretary, and to enrollees
under the plan or coverage, a report on
whether the benefits under the plan or coverage satisfy the elements described in subparagraphs (A) through (D) of paragraph (1).
(B) Timing of reports
A report under subparagraph (A) shall be
made available to an enrollee under the plan
or coverage during each open enrollment period.
(C) Availability of reports
The Secretary shall make reports submitted under subparagraph (A) available to the
public through an Internet website.
1 See

References in Text note below.

Page 1309

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) Penalties
In developing the reporting requirements
under paragraph (1), the Secretary may develop and impose appropriate penalties for
non-compliance with such requirements.
(E) Exceptions
In developing the reporting requirements
under paragraph (1), the Secretary may provide for exceptions to such requirements for
group health plans and health insurance issuers that substantially meet the goals of
this section.
(b) Wellness and prevention programs
For purposes of subsection (a)(1)(D), wellness
and health promotion activities may include
personalized wellness and prevention services,
which are coordinated, maintained or delivered
by a health care provider, a wellness and prevention plan manager, or a health, wellness or prevention services organization that conducts
health risk assessments or offers ongoing faceto-face, telephonic or web-based intervention efforts for each of the program’s participants, and
which may include the following wellness and
prevention efforts:
(1) Smoking cessation.
(2) Weight management.
(3) Stress management.
(4) Physical fitness.
(5) Nutrition.
(6) Heart disease prevention.
(7) Healthy lifestyle support.
(8) Diabetes prevention.
(c) Protection of Second Amendment gun rights
(1) Wellness and prevention programs
A wellness and health promotion activity
implemented under subsection (a)(1)(D) may
not require the disclosure or collection of any
information relating to—
(A) the presence or storage of a lawfullypossessed firearm or ammunition in the residence or on the property of an individual; or
(B) the lawful use, possession, or storage of
a firearm or ammunition by an individual.
(2) Limitation on data collection
None of the authorities provided to the Secretary under the Patient Protection and Affordable Care Act or an amendment made by
that Act shall be construed to authorize or
may be used for the collection of any information relating to—
(A) the lawful ownership or possession of a
firearm or ammunition;
(B) the lawful use of a firearm or ammunition; or
(C) the lawful storage of a firearm or ammunition.
(3) Limitation on databases or data banks
None of the authorities provided to the Secretary under the Patient Protection and Affordable Care Act or an amendment made by
that Act shall be construed to authorize or
may be used to maintain records of individual
ownership or possession of a firearm or ammunition.
(4) Limitation on determination of premium
rates or eligibility for health insurance
A premium rate may not be increased,
health insurance coverage may not be denied,

§ 300gg–17

and a discount, rebate, or reward offered for
participation in a wellness program may not
be reduced or withheld under any health benefit plan issued pursuant to or in accordance
with the Patient Protection and Affordable
Care Act or an amendment made by that Act
on the basis of, or on reliance upon—
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use or storage of a firearm
or ammunition.
(5) Limitation on data collection requirements
for individuals
No individual shall be required to disclose
any information under any data collection activity authorized under the Patient Protection
and Affordable Care Act or an amendment
made by that Act relating to—
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use, possession, or storage of
a firearm or ammunition.
(d) Regulations
Not later than 2 years after March 23, 2010, the
Secretary shall promulgate regulations that
provide criteria for determining whether a reimbursement structure is described in subsection
(a).
(e) Study and report
Not later than 180 days after the date on which
regulations are promulgated under subsection
(c),2 the Government Accountability Office shall
review such regulations and conduct a study and
submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
Representatives a report regarding the impact
the activities under this section have had on the
quality and cost of health care.
(July 1, 1944, ch. 373, title XXVII, § 2717, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(e), Mar. 23, 2010, 124 Stat. 135, 884.)
REFERENCES IN TEXT
Section 3602 of the Patient Protection and Affordable
Care Act, referred to in subsec. (a)(1)(A), is section 3602
of Pub. L. 111–148 which is set out as a note under section 1305w–21 of this title but the reference probably
should be to section 3502 of the Act which is set out as
a note under section 256a–1 of this title.
The Patient Protection and Affordable Care Act, referred to in subsec. (c), is Pub. L. 111–148, Mar. 23, 2010,
124 Stat. 119. For complete classification of this Act to
the Code, see Short Title note set out under section
18001 of this title and Tables.
AMENDMENTS
2010—Subsecs. (c) to (e). Pub. L. 111–148, § 10101(e),
added subsec. (c) and redesignated former subsecs. (c)
and (d) as (d) and (e), respectively.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.
2 So

in original. Probably should be ‘‘subsection (d),’’.

§ 300gg–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300gg–18. Bringing down the cost of health care
coverage
(a) Clear accounting for costs
A health insurance issuer offering group or individual health insurance coverage (including a
grandfathered health plan) shall, with respect to
each plan year, submit to the Secretary a report
concerning the ratio of the incurred loss (or incurred claims) plus the loss adjustment expense
(or change in contract reserves) to earned premiums. Such report shall include the percentage
of total premium revenue, after accounting for
collections or receipts for risk adjustment and
risk corridors and payments of reinsurance, that
such coverage expends—
(1) on reimbursement for clinical services
provided to enrollees under such coverage;
(2) for activities that improve health care
quality; and
(3) on all other non-claims costs, including
an explanation of the nature of such costs, and
excluding Federal and State taxes and licensing or regulatory fees.
The Secretary shall make reports received under
this section available to the public on the Internet website of the Department of Health and
Human Services.
(b) Ensuring that consumers receive value for
their premium payments
(1) Requirement to provide value for premium
payments
(A) Requirement
Beginning not later than January 1, 2011, a
health insurance issuer offering group or individual health insurance coverage (including a grandfathered health plan) shall, with
respect to each plan year, provide an annual
rebate to each enrollee under such coverage,
on a pro rata basis, if the ratio of the
amount of premium revenue expended by the
issuer on costs described in paragraphs (1)
and (2) of subsection (a) to the total amount
of premium revenue (excluding Federal and
State taxes and licensing or regulatory fees
and after accounting for payments or receipts for risk adjustment, risk corridors,
and reinsurance under sections 18061, 18062,
and 18063 of this title) for the plan year (except as provided in subparagraph (B)(ii)), is
less than—
(i) with respect to a health insurance issuer offering coverage in the large group
market, 85 percent, or such higher percentage as a State may by regulation determine; or
(ii) with respect to a health insurance issuer offering coverage in the small group
market or in the individual market, 80 percent, or such higher percentage as a State
may by regulation determine, except that
the Secretary may adjust such percentage
with respect to a State if the Secretary determines that the application of such 80
percent may destabilize the individual
market in such State.

Page 1310

(B) Rebate amount
(i) Calculation of amount
The total amount of an annual rebate required under this paragraph shall be in an
amount equal to the product of—
(I) the amount by which the percentage described in clause (i) or (ii) of subparagraph (A) exceeds the ratio described in such subparagraph; and
(II) the total amount of premium revenue (excluding Federal and State taxes
and licensing or regulatory fees and
after accounting for payments or receipts for risk adjustment, risk corridors, and reinsurance under sections
18061, 18062, and 18063 of this title) for
such plan year.
(ii) Calculation based on average ratio
Beginning on January 1, 2014, the determination made under subparagraph (A) for
the year involved shall be based on the
averages of the premiums expended on the
costs described in such subparagraph and
total premium revenue for each of the previous 3 years for the plan.
(2) Consideration in setting percentages
In determining the percentages under paragraph (1), a State shall seek to ensure adequate participation by health insurance issuers, competition in the health insurance market in the State, and value for consumers so
that premiums are used for clinical services
and quality improvements.
(3) Enforcement
The Secretary shall promulgate regulations
for enforcing the provisions of this section and
may provide for appropriate penalties.
(c) Definitions
Not later than December 31, 2010, and subject
to the certification of the Secretary, the National Association of Insurance Commissioners
shall establish uniform definitions of the activities reported under subsection (a) and standardized methodologies for calculating measures of
such activities, including definitions of which
activities, and in what regard such activities,
constitute activities described in subsection
(a)(2). Such methodologies shall be designed to
take into account the special circumstances of
smaller plans, different types of plans, and
newer plans.
(d) Adjustments
The Secretary may adjust the rates described
in subsection (b) if the Secretary determines appropriate on account of the volatility of the individual market due to the establishment of
State Exchanges.
(e) Standard hospital charges
Each hospital operating within the United
States shall for each year establish (and update)
and make public (in accordance with guidelines
developed by the Secretary) a list of the hospital’s standard charges for items and services
provided by the hospital, including for diagnosis-related groups established under section
1395ww(d)(4) of this title.

Page 1311

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XXVII, § 2718, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(f), Mar. 23, 2010, 124 Stat. 136, 885.)
AMENDMENTS
2010—Pub. L. 111–148, § 10101(f), amended section generally. Prior to amendment, the section related to
clear accounting for costs, ensuring that consumers receive value for premiums, standard hospital charges,
and definitions.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–19. Appeals process
(a) Internal claims appeals
(1) In general
A group health plan and a health insurance
issuer offering group or individual health insurance coverage shall implement an effective
appeals process for appeals of coverage determinations and claims, under which the plan or
issuer shall, at a minimum—
(A) have in effect an internal claims appeal process;
(B) provide notice to enrollees, in a culturally and linguistically appropriate manner, of available internal and external appeals processes, and the availability of any
applicable office of health insurance consumer assistance or ombudsman established
under section 300gg–93 of this title to assist
such enrollees with the appeals processes;
and
(C) allow an enrollee to review their file,
to present evidence and testimony as part of
the appeals process, and to receive continued
coverage pending the outcome of the appeals
process.
(2) Established processes
To comply with paragraph (1)—
(A) a group health plan and a health insurance issuer offering group health coverage
shall provide an internal claims and appeals
process that initially incorporates the
claims and appeals procedures (including urgent claims) set forth at section 2560.503–1 of
title 29, Code of Federal Regulations, as published on November 21, 2000 (65 Fed. Reg.
70256), and shall update such process in accordance with any standards established by
the Secretary of Labor for such plans and issuers; and
(B) a health insurance issuer offering individual health coverage, and any other issuer
not subject to subparagraph (A), shall provide an internal claims and appeals process
that initially incorporates the claims and
appeals procedures set forth under applicable law (as in existence on March 23, 2010),
and shall update such process in accordance
with any standards established by the Secretary of Health and Human Services for
such issuers.
(b) External review
A group health plan and a health insurance issuer offering group or individual health insurance coverage—

§ 300gg–19a

(1) shall comply with the applicable State
external review process for such plans and issuers that, at a minimum, includes the consumer protections set forth in the Uniform External Review Model Act promulgated by the
National Association of Insurance Commissioners and is binding on such plans; or
(2) shall implement an effective external review process that meets minimum standards
established by the Secretary through guidance
and that is similar to the process described
under paragraph (1)—
(A) if the applicable State has not established an external review process that meets
the requirements of paragraph (1); or
(B) if the plan is a self-insured plan that is
not subject to State insurance regulation
(including a State law that establishes an
external review process described in paragraph (1)).
(c) Secretary authority
The Secretary may deem the external review
process of a group health plan or health insurance issuer, in operation as of the date of enactment of this section, to be in compliance with
the applicable process established under subsection (b), as determined appropriate by the
Secretary.
(July 1, 1944, ch. 373, title XXVII, § 2719, as added
and amended Pub. L. 111–148, title I, § 1001(5),
title X, § 10101(g), Mar. 23, 2010, 124 Stat. 137, 887.)
AMENDMENTS
2010—Pub. L. 111–148, § 10101(g), amended section generally. Prior to amendment, section related to implementation of appeals process by group health plans and
health insurance issuers.
EFFECTIVE DATE
Section effective for plan years beginning on or after
the date that is 6 months after Mar. 23, 2010, see section
1004 of Pub. L. 111–148, set out as a note under section
300gg–11 of this title.

§ 300gg–19a. Patient protections
(a) Choice of health care professional
If a group health plan, or a health insurance
issuer offering group or individual health insurance coverage, requires or provides for designation by a participant, beneficiary, or enrollee of
a participating primary care provider, then the
plan or issuer shall permit each participant,
beneficiary, and enrollee to designate any participating primary care provider who is available to accept such individual.
(b) Coverage of emergency services
(1) In general
If a group health plan, or a health insurance
issuer offering group or individual health insurance issuer,1 provides or covers any benefits with respect to services in an emergency
department of a hospital, the plan or issuer
shall cover emergency services (as defined in
paragraph (2)(B))—
(A) without the need for any prior authorization determination;
(B) whether the health care provider furnishing such services is a participating provider with respect to such services;
1 So

in original. Probably should be ‘‘coverage,’’.

§ 300gg–19a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) in a manner so that, if such services
are provided to a participant, beneficiary, or
enrollee—
(i) by a nonparticipating health care provider with or without prior authorization;
or
(ii)(I) such services will be provided
without imposing any requirement under
the plan for prior authorization of services
or any limitation on coverage where the
provider of services does not have a contractual relationship with the plan for the
providing of services that is more restrictive than the requirements or limitations
that apply to emergency department services received from providers who do have
such a contractual relationship with the
plan; and
(II) if such services are provided out-ofnetwork, the cost-sharing requirement (expressed as a copayment amount or coinsurance rate) is the same requirement that
would apply if such services were provided
in-network; 2
(D) without regard to any other term or
condition of such coverage (other than exclusion or coordination of benefits, or an affiliation or waiting period, permitted under
section 2701 3 of this Act, section 1181 of title
29, or section 9801 of title 26, and other than
applicable cost-sharing).
(2) Definitions
In this subsection:
(A) Emergency medical condition
The term ‘‘emergency medical condition’’
means a medical condition manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that a prudent
layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section
1395dd(e)(1)(A) of this title.
(B) Emergency services
The term ‘‘emergency services’’ means,
with respect to an emergency medical condition—
(i) a medical screening examination (as
required under section 1395dd of this title)
that is within the capability of the emergency department of a hospital, including
ancillary services routinely available to
the emergency department to evaluate
such emergency medical condition, and
(ii) within the capabilities of the staff
and facilities available at the hospital,
such further medical examination and
treatment as are required under section
1395dd of this title to stabilize the patient.
(C) Stabilize
The term ‘‘to stabilize’’, with respect to an
emergency medical condition (as defined in
subparagraph (A)), has the meaning give 4 in
section 1395dd(e)(3) of this title.
2 So

in original. The word ‘‘and’’ probably should appear.
References in Text note below.
4 So in original. Probably should be ‘‘given’’.
3 See

Page 1312

(c) Access to pediatric care
(1) Pediatric care
In the case of a person who has a child who
is a participant, beneficiary, or enrollee under
a group health plan, or health insurance coverage offered by a health insurance issuer in
the group or individual market, if the plan or
issuer requires or provides for the designation
of a participating primary care provider for
the child, the plan or issuer shall permit such
person to designate a physician (allopathic or
osteopathic) who specializes in pediatrics as
the child’s primary care provider if such provider participates in the network of the plan
or issuer.
(2) Construction
Nothing in paragraph (1) shall be construed
to waive any exclusions of coverage under the
terms and conditions of the plan or health insurance coverage with respect to coverage of
pediatric care.
(d) Patient access to obstetrical and gynecological care
(1) General rights
(A) Direct access
A group health plan, or health insurance
issuer offering group or individual health insurance coverage, described in paragraph (2)
may not require authorization or referral by
the plan, issuer, or any person (including a
primary care provider described in paragraph (2)(B)) in the case of a female participant, beneficiary, or enrollee who seeks coverage for obstetrical or gynecological care
provided by a participating health care professional who specializes in obstetrics or
gynecology. Such professional shall agree to
otherwise adhere to such plan’s or issuer’s
policies and procedures, including procedures regarding referrals and obtaining prior
authorization and providing services pursuant to a treatment plan (if any) approved by
the plan or issuer.
(B) Obstetrical and gynecological care
A group health plan or health insurance issuer described in paragraph (2) shall treat
the provision of obstetrical and gynecological care, and the ordering of related obstetrical and gynecological items and services, pursuant to the direct access described
under subparagraph (A), by a participating
health care professional who specializes in
obstetrics or gynecology as the authorization of the primary care provider.
(2) Application of paragraph
A group health plan, or health insurance issuer offering group or individual health insurance coverage, described in this paragraph is a
group health plan or coverage that—
(A) provides coverage for obstetric or
gynecologic care; and
(B) requires the designation by a participant, beneficiary, or enrollee of a participating primary care provider.
(3) Construction
Nothing in paragraph (1) shall be construed
to—

Page 1313

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) waive any exclusions of coverage under
the terms and conditions of the plan or
health insurance coverage with respect to
coverage of obstetrical or gynecological
care; or
(B) preclude the group health plan or
health insurance issuer involved from requiring that the obstetrical or gynecological
provider notify the primary care health care
professional or the plan or issuer of treatment decisions.
(July 1, 1944, ch. 373, title XXVII, § 2719A, as
added Pub. L. 111–148, title X, § 10101(h), Mar. 23,
2010, 124 Stat. 888.)
REFERENCES IN TEXT
Section 2701 of this Act, referred to in subsec.
(b)(1)(D), is a reference to section 2701 of act July 1,
1944. Section 2701, which was classified to section 300gg
of this title, was renumbered section 2704, effective for
plan years beginning on or after Jan. 1, 2014, with certain exceptions, and amended, by Pub. L. 111–148, title
I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911, and was
transferred to section 300gg–3 of this title. A new section 2701 of act July 1, 1944, related to fair health insurance premiums, was added, effective for plan years beginning on or after Jan. 1, 2014, and amended, by Pub.
L. 111–148, title I, § 1201(4), title X, § 10103(a), Mar. 23,
2010, 124 Stat. 155, 892, and is classified to section 300gg
of this title.
CODIFICATION
Pub. L. 111–148, which directed amendment of subpart
II of part A of ‘‘title XVIII’’ of act July 1, 1944, by inserting section 2719A after section 2719, was executed
by making the insertion in subpart II of part A of title
XXVII of the Act, to reflect the probable intent of Congress.
SUBPART 2—EXCLUSION OF PLANS; ENFORCEMENT;
PREEMPTION

CODIFICATION
This subpart 2 designation and heading was transferred along with sections 300gg–21 to 300gg–23 of this
title to appear before section 300gg–25 of this title to reflect the renumbering of the sections in the original
act by Pub. L. 111–148, title I, §§ 1001(4), 1563(c)(12)(D),
(13)(C), (14)(B), formerly § 1562(c)(12)(D), (13)(C), (14)(B),
title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.
AMENDMENTS
2010—Pub. L. 111–148, title I, § 1563(c)(11), formerly
§ 1562(c)(11), title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat.
268, 911, redesignated subpart 4 as subpart 2.
1996—Pub. L. 104–204, title VI, § 604(a)(2), Sept. 26, 1996,
110 Stat. 2939, redesignated subpart 3 as 4.

§ 300gg–21. Exclusion of certain plans
(a) Limitation on application of provisions relating to group health plans
(1) In general
The requirements of subparts 1 and 2 1 shall
apply with respect to group health plans
only—
(A) subject to paragraph (2), in the case of
a plan that is a nonfederal governmental
plan, and
(B) with respect to health insurance coverage offered in connection with a group
1 See

References in Text note below.

§ 300gg–21

health plan (including such a plan that is a
church plan or a governmental plan).
(2) Treatment of non-Federal governmental
plans
(A) Election to be excluded
Except as provided in subparagraph (D) or
(E), if the plan sponsor of a nonfederal governmental plan which is a group health plan
to which the provisions of subparts 1 and 2 1
otherwise apply makes an election under
this subparagraph (in such form and manner
as the Secretary may by regulations prescribe), then the requirements of such subparts insofar as they apply directly to group
health plans (and not merely to group health
insurance coverage) shall not apply to such
governmental plans for such period except as
provided in this paragraph.
(B) Period of election
An election under subparagraph (A) shall
apply—
(i) for a single specified plan year, or
(ii) in the case of a plan provided pursuant to a collective bargaining agreement,
for the term of such agreement.
An election under clause (i) may be extended
through subsequent elections under this
paragraph.
(C) Notice to enrollees
Under such an election, the plan shall provide for—
(i) notice to enrollees (on an annual
basis and at the time of enrollment under
the plan) of the fact and consequences of
such election, and
(ii) certification and disclosure of creditable coverage under the plan with respect to enrollees in accordance with section 2701(e).1
(D) Election not applicable to requirements
concerning genetic information
The election described in subparagraph (A)
shall not be available with respect to the
provisions of subsections (a)(1)(F), (b)(3), (c),
and (d) of section 2702 1 and the provisions of
sections 2701 1 and 2702(b) 1 to the extent that
such provisions apply to genetic information.
(E) Election not applicable
The election described in subparagraph (A)
shall not be available with respect to the
provisions of subparts I and II.
(b) Exception for certain benefits
The requirements of subparts 1 and 2 1 shall
not apply to any individual coverage or any
group health plan (or group health insurance
coverage) in relation to its provision of excepted
benefits described in section 300gg–91(c)(1) of
this title.
(c) Exception for certain benefits if certain conditions met
(1) Limited, excepted benefits
The requirements of subparts 1 and 2 1 shall
not apply to any individual coverage or any
group health plan (and group health insurance

§ 300gg–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

coverage offered in connection with a group
health plan) in relation to its provision of excepted
benefits
described
in
section
300gg–91(c)(2) of this title if the benefits—
(A) are provided under a separate policy,
certificate, or contract of insurance; or
(B) are otherwise not an integral part of
the plan.
(2) Noncoordinated, excepted benefits
The requirements of subparts 1 and 2 1 shall
not apply to any individual coverage or any
group health plan (and group health insurance
coverage offered in connection with a group
health plan) in relation to its provision of excepted
benefits
described
in
section
300gg–91(c)(3) of this title if all of the following
conditions are met:
(A) The benefits are provided under a separate policy, certificate, or contract of insurance.
(B) There is no coordination between the
provision of such benefits and any exclusion
of benefits under any group health plan
maintained by the same plan sponsor.
(C) Such benefits are paid with respect to
an event without regard to whether benefits
are provided with respect to such an event
under any group health plan maintained by
the same plan sponsor or, with respect to individual coverage, under any health insurance coverage maintained by the same
health insurance issuer.
(3) Supplemental excepted benefits
The requirements of this part shall not
apply to any individual coverage or any group
health plan (and group health insurance coverage) in relation to its provision of excepted
benefits described in section 300gg–91(c)(4) 1 of
this title if the benefits are provided under a
separate policy, certificate, or contract of insurance.
(d) Treatment of partnerships
For purposes of this part—
(1) Treatment as a group health plan
Any plan, fund, or program which would not
be (but for this subsection) an employee welfare benefit plan and which is established or
maintained by a partnership, to the extent
that such plan, fund, or program provides medical care (including items and services paid for
as medical care) to present or former partners
in the partnership or to their dependents (as
defined under the terms of the plan, fund, or
program), directly or through insurance, reimbursement, or otherwise, shall be treated (subject to paragraph (2)) as an employee welfare
benefit plan which is a group health plan.
(2) Employer
In the case of a group health plan, the term
‘‘employer’’ also includes the partnership in
relation to any partner.
(3) Participants of group health plans
In the case of a group health plan, the term
‘‘participant’’ also includes—
(A) in connection with a group health plan
maintained by a partnership, an individual
who is a partner in relation to the partnership, or

Page 1314

(B) in connection with a group health plan
maintained by a self-employed individual
(under which one or more employees are participants), the self-employed individual,
if such individual is, or may become, eligible
to receive a benefit under the plan or such individual’s beneficiaries may be eligible to receive any such benefit.
(July 1, 1944, ch. 373, title XXVII, § 2722, formerly
§ 2721, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1967; amended Pub. L.
104–204, title VI, § 604(b)(1), Sept. 26, 1996, 110
Stat. 2940; Pub. L. 110–233, title I, § 102(c), May
21, 2008, 122 Stat. 895; renumbered § 2735, renumbered § 2722, and amended Pub. L. 111–148, title I,
§§ 1001(4), 1563(a), (c)(12), formerly § 1562(a),
(c)(12), title X, § 10107(a), (b)(1), Mar. 23, 2010, 124
Stat. 130, 264, 268, 911.)
REFERENCES IN TEXT
Subparts 1 and 2, referred to in subsecs. (a)(1), (2)(A),
(b), and (c)(1), (2), may refer to subparts I and II of this
part. Pub. L. 111–148, title I, §§ 1001(5), 1201(1), 1563(c)(2),
(11), formerly § 1562(c)(2), (11), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 130, 154, 265, 268, 911, amended this part
by substituting ‘‘SUBPART I—GENERAL REFORM’’ for
‘‘SUBPART 1—PORTABILITY, ACCESS, AND RENEWABILITY
REQUIREMENTS’’ (preceding section 300gg of this title),
effective for plan years beginning on or after Jan. 1,
2014, by inserting SUBPART II—IMPROVING COVERAGE’’
(preceding section 300gg–11 of this title), by striking
out ‘‘SUBPART 2—OTHER REQUIREMENTS’’ (preceding section 300gg–4 of this title), and by redesignating subpart
4 as subpart 2 ‘‘EXCLUSION OF PLANS; ENFORCEMENT; PREEMPTION’’ (preceding section 300gg–21 of this title).
Section 2701, referred to in subsec. (a)(2)(C)(ii), (D), is
a reference to section 2701 of act July 1, 1944. Section
2701, which was classified to section 300gg of this title,
was renumbered section 2704, effective for plan years
beginning on or after Jan. 1, 2014, with certain exceptions, and amended, by Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1), formerly § 1562(c)(1), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 154, 264, 911, and was transferred to
section 300gg–3 of this title. A new section 2701 of act
July 1, 1944, related to fair health insurance premiums,
was added, effective for plan years beginning on or
after Jan. 1, 2014, and amended, by Pub. L. 111–148, title
I, § 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
Section 2702, referred to in subsec. (a)(2)(D), is a reference to section 2702 of act July 1, 1944. Section 2702,
which was classified to section 300gg–1 of this title, was
amended by Pub. L. 111–148, title I, § 1201(3), Mar. 23,
2010, 124 Stat. 154, and was transferred to subsecs. (d) to
(f) of section 300gg–4 of this title, effective for plan
years beginning on or after Jan. 1, 2014. A new section
2702 of act July 1, 1944, related to guaranteed availability of coverage, was added by Pub. L. 111–148, title I,
§ 1201(4), Mar. 23, 2010, 124 Stat. 156, effective for plan
years beginning on or after Jan. 1, 2014, and is classified
to section 300gg–1 of this title.
Section 300gg–91(c)(4) of this title, referred to in subsec. (c)(3), was in the original ‘‘section 27971(c)(4)’’ and
was translated as reading ‘‘section 2791(c)(4)’’, meaning
section 2791(c)(4) of act July 1, 1944, as added by Pub. L.
104–191, § 102(a), to reflect the probable intent of Congress. Act July 1, 1944, does not contain a section 27971.
PRIOR PROVISIONS
A prior section 2722 of act July 1, 1944, was renumbered section 2723 and is classified to section 300gg–22 of
this title.
AMENDMENTS
2010—Pub. L. 111–148, § 1563(c)(12)(B), formerly
§ 1562(c)(12)(B), as renumbered by Pub. L. 111–148,

Page 1315

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 10107(b)(1), which directed amendment of section by
substituting ‘‘subpart 1’’ for ‘‘subparts 1 through 3’’
wherever appearing, could not be executed because the
words ‘‘subparts 1 through 3’’ did not appear subsequent
to amendments by section 1563(a)(2)(A), (B)(ii), (3),
(4)(A), (B)(i) of Pub. L. 111–148. See below.
Subsec. (a). Pub. L. 111–148, § 1563(c)(12)(C), formerly
§ 1562(c)(12)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), redesignated subsec. (b) as (a).
Pub. L. 111–148, §§ 1563(a)(1) and 1563(c)(12)(A), formerly §§ 1562(a)(1) and 1562(c)(12)(A), as renumbered by
Pub. L. 111–148, § 10107(b)(1), made identical amendment,
striking out subsec. (a). Prior to amendment, text read
as follows: ‘‘The requirements of subparts 1 and 3 shall
not apply to any group health plan (and health insurance coverage offered in connection with a group
health plan) for any plan year if, on the first day of
such plan year, such plan has less than 2 participants
who are current employees.’’
Subsec. (b). Pub. L. 111–148, § 1563(c)(12)(C), formerly
§ 1562(c)(12)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (a).
Pub. L. 111–148, § 1563(a)(2)(A), formerly § 1562(a)(2)(A),
as renumbered by Pub. L. 111–148, § 10107(b)(1), substituted ‘‘subparts 1 and 2’’ for ‘‘subparts 1 through 3’’
in introductory provisions.
Pub.
L.
111–148,
§ 1563(a)(2)(B)(ii),
formerly
§ 1562(a)(2)(B)(ii), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘subparts 1 and 2’’ for ‘‘subparts 1 through 3’’.
Pub.
L.
111–148,
§ 1563(a)(2)(B)(i),
formerly
§ 1562(a)(2)(B)(i), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘subparagraph (D) or (E)’’ for
‘‘subparagraph (D)’’.
Subsec. (b)(2)(E). Pub. L. 111–148, § 10107(a), substituted ‘‘subparts I and II’’ for ‘‘subpart 1’’.
Pub.
L.
111–148,
§ 1563(a)(2)(B)(iii),
formerly
§ 1562(a)(2)(B)(iii), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), added subpar. (E).
Subsec. (c). Pub. L. 111–148, § 1563(c)(12)(C), formerly
§ 1562(c)(12)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), redesignated subsec. (d) as (c). Former subsec. (c) redesignated (b).
Pub. L. 111–148, § 1563(a)(3), formerly § 1562(a)(3), as renumbered by Pub. L. 111–148, § 10107(b)(1), substituted
‘‘subparts 1 and 2 shall not apply to any individual coverage or any group’’ for ‘‘subparts 1 through 3 shall not
apply to any group’’.
Subsec. (d). Pub. L. 111–148, § 1563(c)(12)(C), formerly
§ 1562(c)(12)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), redesignated subsec. (e) as (d). Former subsec. (d) redesignated (c).
Pub. L. 111–148, § 1563(a)(4)(A), formerly § 1562(a)(4)(A),
as renumbered by Pub. L. 111–148, § 10107(b)(1), substituted ‘‘subparts 1 and 2 shall not apply to any individual coverage or any group’’ for ‘‘subparts 1 through
3 shall not apply to any group’’ in introductory provisions.
Pub.
L.
111–148,
§ 1563(a)(4)(B)(i),
formerly
§ 1562(a)(4)(B)(i), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘subparts 1 and 2 shall not
apply to any individual coverage or any group’’ for
‘‘subparts 1 through 3 shall not apply to any group’’ in
introductory provisions.
Subsec. (d)(2)(C). Pub. L. 111–148, § 1563(a)(4)(B)(ii), formerly § 1562(a)(4)(B)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), which directed amendment of subpar. (C) by inserting ‘‘or, with respect to individual
coverage, under any health insurance coverage maintained by the same health insurance issuer’’ without
language specifying placement, was executed by making the insertion before period at end to reflect the
probable intent of Congress.
Subsec. (d)(3). Pub. L. 111–148, § 1563(a)(4)(C), formerly
§ 1562(a)(4)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘any individual coverage or
any group’’ for ‘‘any group’’.
Subsec. (e). Pub. L. 111–148, § 1563(c)(12)(C), formerly
§ 1562(c)(12)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), redesignated subsec. (e) as (d).

§ 300gg–21

2008—Subsec. (b)(2)(A). Pub. L. 110–233, § 102(c)(1), substituted ‘‘Except as provided in subparagraph (D), if the
plan sponsor’’ for ‘‘If the plan sponsor’’.
Subsec. (b)(2)(D). Pub. L. 110–233, § 102(c)(2), added subpar. (D).
1996—Subsec. (a). Pub. L. 104–204, § 604(b)(1)(A), substituted ‘‘subparts 1 and 3’’ for ‘‘subparts 1 and 2’’.
Subsec. (b) to (d). Pub. L. 104–204, § 604(b)(1)(B), substituted ‘‘subparts 1 through 3’’ for ‘‘subparts 1 and 2’’
wherever appearing.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–233, title I, § 102(d)(2), May 21, 2008, 122
Stat. 895, provided that: ‘‘The amendments made by
this section [enacting section 300gg–53 of this title and
amending this section and sections 300gg–1, 300gg–22,
300gg–61, and 300gg–91 of this title] shall apply—
‘‘(A) with respect to group health plans, and health
insurance coverage offered in connection with group
health plans, for plan years beginning after the date
that is 1 year after the date of enactment of this Act
[May 21, 2008]; and
‘‘(B) with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in
the individual market after the date that is 1 year
after the date of enactment of this Act.’’
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–204 applicable with respect to group health plans for plan years beginning on
or after Jan. 1, 1998, see section 604(c) of Pub. L. 104–204
set out as an Effective Date note under section 300gg–25
of this title.
EFFECTIVE DATE
Section applicable with respect to group health
plans, and health insurance coverage offered in connection with group health plans, for plan years beginning
after June 30, 1997, except as otherwise provided, see
section 102(c) of Pub. L. 104–191, set out as a note under
section 300gg of this title.
REGULATIONS
Pub. L. 110–233, title I, § 102(d)(1), May 21, 2008, 122
Stat. 895, provided that: ‘‘Not later than 12 months
after the date of enactment of this Act [May 21, 2008],
the Secretary of Health and Human Services shall issue
final regulations to carry out the amendments made by
this section [see Effective Date of 2008 Amendment note
above].’’
ASSURING COORDINATION
Pub. L. 110–233, title I, § 106, May 21, 2008, 122 Stat. 905,
provided that: ‘‘Except as provided in section 105(b)(1)
[set out as a note under section 1320d–9 of this title],
the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury
shall ensure, through the execution of an interagency
memorandum of understanding among such Secretaries, that—
‘‘(1) regulations, rulings, and interpretations issued
by such Secretaries relating to the same matter over
which two or more such Secretaries have responsibility under this title [enacting sections 300gg–53 and
1320d–9 of this title and section 9834 of Title 26, Internal Revenue Code, amending this section, sections
300gg–1, 300gg–22, 300gg–61, 300gg–91, and 1395ss of this
title, sections 9802 and 9832 of Title 26, and sections
1132, 1182, and 1191b of Title 29, Labor, and enacting
provisions set out as notes under this section, sections 1320d–9 and 1395ss of this title, section 9802 of
Title 26, and section 1132 of Title 29] (and the amendments made by this title) are administered so as to
have the same effect at all times; and
‘‘(2) coordination of policies relating to enforcing
the same requirements through such Secretaries in
order to have a coordinated enforcement strategy
that avoids duplication of enforcement efforts and assigns priorities in enforcement.’’

§ 300gg–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300gg–22. Enforcement
(a) State enforcement
(1) State authority
Subject to section 300gg–23 1 of this title,
each State may require that health insurance
issuers that issue, sell, renew, or offer health
insurance coverage in the State in the individual or group market meet the requirements of
this part with respect to such issuers.
(2) Failure to implement provisions
In the case of a determination by the Secretary that a State has failed to substantially
enforce a provision (or provisions) in this part
with respect to health insurance issuers in the
State, the Secretary shall enforce such provision (or provisions) under subsection (b) of
this section insofar as they relate to the issuance, sale, renewal, and offering of health insurance coverage in connection with group
health plans or individual health insurance
coverage in such State.
(b) Secretarial enforcement authority
(1) Limitation
The provisions of this subsection shall apply
to enforcement of a provision (or provisions)
of this part only—
(A) as provided under subsection (a)(2) of
this section; and
(B) with respect to individual health insurance coverage or group health plans that are
non-Federal governmental plans.
(2) Imposition of penalties
In the cases described in paragraph (1)—
(A) In general
Subject to the succeeding provisions of
this subsection, any non-Federal governmental plan that is a group health plan and
any health insurance issuer that fails to
meet a provision of this part applicable to
such plan or issuer is subject to a civil
money penalty under this subsection.
(B) Liability for penalty
In the case of a failure by—
(i) a health insurance issuer, the issuer is
liable for such penalty, or
(ii) a group health plan that is a nonFederal governmental plan which is—
(I) sponsored by 2 or more employers,
the plan is liable for such penalty, or
(II) not so sponsored, the employer is
liable for such penalty.
(C) Amount of penalty
(i) In general
The maximum amount of penalty imposed under this paragraph is $100 for each
day for each individual with respect to
which such a failure occurs.
(ii) Considerations in imposition
In determining the amount of any penalty to be assessed under this paragraph,
the Secretary shall take into account the
previous record of compliance of the entity
1 See

References in Text note below.

Page 1316

being assessed with the applicable provisions of this part and the gravity of the
violation.
(iii) Limitations
(I) Penalty not to apply where failure not
discovered exercising reasonable diligence
No civil money penalty shall be imposed under this paragraph on any failure during any period for which it is established to the satisfaction of the Secretary that none of the entities against
whom the penalty would be imposed
knew, or exercising reasonable diligence
would have known, that such failure existed.
(II) Penalty not to apply to failures corrected within 30 days
No civil money penalty shall be imposed under this paragraph on any failure if such failure was due to reasonable
cause and not to willful neglect, and
such failure is corrected during the 30day period beginning on the first day any
of the entities against whom the penalty
would be imposed knew, or exercising
reasonable diligence would have known,
that such failure existed.
(D) Administrative review
(i) Opportunity for hearing
The entity assessed shall be afforded an
opportunity for hearing by the Secretary
upon request made within 30 days after the
date of the issuance of a notice of assessment. In such hearing the decision shall be
made on the record pursuant to section 554
of title 5. If no hearing is requested, the assessment shall constitute a final and unappealable order.
(ii) Hearing procedure
If a hearing is requested, the initial
agency decision shall be made by an administrative law judge, and such decision
shall become the final order unless the
Secretary modifies or vacates the decision.
Notice of intent to modify or vacate the
decision of the administrative law judge
shall be issued to the parties within 30
days after the date of the decision of the
judge. A final order which takes effect
under this paragraph shall be subject to review only as provided under subparagraph
(E).
(E) Judicial review
(i) Filing of action for review
Any entity against whom an order imposing a civil money penalty has been entered after an agency hearing under this
paragraph may obtain review by the
United States district court for any district in which such entity is located or the
United States District Court for the District of Columbia by filing a notice of appeal in such court within 30 days from the
date of such order, and simultaneously
sending a copy of such notice by registered
mail to the Secretary.

Page 1317

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) Certification of administrative record
The Secretary shall promptly certify and
file in such court the record upon which
the penalty was imposed.
(iii) Standard for review
The findings of the Secretary shall be set
aside only if found to be unsupported by
substantial evidence as provided by section 706(2)(E) of title 5.
(iv) Appeal
Any final decision, order, or judgment of
the district court concerning such review
shall be subject to appeal as provided in
chapter 83 of title 28.
(F) Failure to pay assessment; maintenance
of action
(i) Failure to pay assessment
If any entity fails to pay an assessment
after it has become a final and unappealable order, or after the court has entered
final judgment in favor of the Secretary,
the Secretary shall refer the matter to the
Attorney General who shall recover the
amount assessed by action in the appropriate United States district court.
(ii) Nonreviewability
In such action the validity and appropriateness of the final order imposing the
penalty shall not be subject to review.
(G) Payment of penalties
Except as otherwise provided, penalties
collected under this paragraph shall be paid
to the Secretary (or other officer) imposing
the penalty and shall be available without
appropriation and until expended for the
purpose of enforcing the provisions with respect to which the penalty was imposed.
(3) Enforcement authority relating to genetic
discrimination
(A) General rule
In the cases described in paragraph (1),
notwithstanding the provisions of paragraph
(2)(C), the succeeding subparagraphs of this
paragraph shall apply with respect to an action under this subsection by the Secretary
with respect to any failure of a health insurance issuer in connection with a group
health plan, to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of section 2702 1 or section 2701 1 or 2702(b)(1) 1 with
respect to genetic information in connection
with the plan.
(B) Amount
(i) In general
The amount of the penalty imposed
under this paragraph shall be $100 for each
day in the noncompliance period with respect to each participant or beneficiary to
whom such failure relates.
(ii) Noncompliance period
For purposes of this paragraph, the term
‘‘noncompliance period’’ means, with respect to any failure, the period—
(I) beginning on the date such failure
first occurs; and

§ 300gg–22

(II) ending on the date the failure is
corrected.
(C) Minimum penalties where failure discovered
Notwithstanding clauses (i) and (ii) of subparagraph (D):
(i) In general
In the case of 1 or more failures with respect to an individual—
(I) which are not corrected before the
date on which the plan receives a notice
from the Secretary of such violation;
and
(II) which occurred or continued during
the period involved;
the amount of penalty imposed by subparagraph (A) by reason of such failures
with respect to such individual shall not
be less than $2,500.
(ii) Higher minimum penalty where violations are more than de minimis
To the extent violations for which any
person is liable under this paragraph for
any year are more than de minimis, clause
(i) shall be applied by substituting
‘‘$15,000’’ for ‘‘$2,500’’ with respect to such
person.
(D) Limitations
(i) Penalty not to apply where failure not
discovered exercising reasonable diligence
No penalty shall be imposed by subparagraph (A) on any failure during any period
for which it is established to the satisfaction of the Secretary that the person
otherwise liable for such penalty did not
know, and exercising reasonable diligence
would not have known, that such failure
existed.
(ii) Penalty not to apply to failures corrected within certain periods
No penalty shall be imposed by subparagraph (A) on any failure if—
(I) such failure was due to reasonable
cause and not to willful neglect; and
(II) such failure is corrected during the
30-day period beginning on the first date
the person otherwise liable for such penalty knew, or exercising reasonable diligence would have known, that such failure existed.
(iii) Overall limitation for unintentional
failures
In the case of failures which are due to
reasonable cause and not to willful neglect, the penalty imposed by subparagraph (A) for failures shall not exceed the
amount equal to the lesser of—
(I) 10 percent of the aggregate amount
paid or incurred by the employer (or
predecessor employer) during the preceding taxable year for group health plans;
or
(II) $500,000.
(E) Waiver by Secretary
In the case of a failure which is due to reasonable cause and not to willful neglect, the

§ 300gg–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Secretary may waive part or all of the penalty imposed by subparagraph (A) to the extent that the payment of such penalty would
be excessive relative to the failure involved.
(July 1, 1944, ch. 373, title XXVII, § 2723, formerly
§ 2722, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1968; amended Pub. L.
110–233, title I, § 102(a)(5), May 21, 2008, 122 Stat.
891; renumbered § 2736, renumbered § 2723, and
amended Pub. L. 111–148, title I, §§ 1001(4),
1563(c)(13),
formerly
§ 1562(c)(13),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.)
REFERENCES IN TEXT
Section 300gg–23 of this title, referred to in subsec.
(a)(1), was in the original section ‘‘2723’’, and was translated as meaning section 2724 of act July 1, 1944, to reflect the probable intent of Congress and the renumbering of section 2723 as 2724 by Pub. L. 111–148, title I,
§§ 1001(4), 1563(c)(14)(B), formerly § 1562(c)(14)(B), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.
Section 2702, referred to in subsec. (b)(3)(A), is a reference to section 2702 of act July 1, 1944. Section 2702,
which was classified to section 300gg–1 of this title, was
amended by Pub. L. 111–148, title I, § 1201(3), Mar. 23,
2010, 124 Stat. 154, and was transferred to subsecs. (d) to
(f) of section 300gg–4 of this title, effective for plan
years beginning on or after Jan. 1, 2014. A new section
2702, related to guaranteed availability of coverage, was
added by Pub. L. 111–148, title I, § 1201(4), Mar. 23, 2010,
124 Stat. 156, effective for plan years beginning on or
after Jan. 1, 2014, and is classified to section 300gg–1 of
this title.
Section 2701, referred to in subsec. (b)(3)(A), is a reference to section 2701 of act July 1, 1944. Section 2701,
which was classified to section 300gg of this title, was
renumbered section 2704, effective for plan years beginning on or after Jan. 1, 2014, with certain exceptions,
and amended, by Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1), formerly § 1562(c)(1), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 154, 264, 911, and was transferred to
section 300gg–3 of this title. A new section 2701 of act
July 1, 1944, related to fair health insurance premiums,
was added, effective for plan years beginning on or
after Jan. 1, 2014, and amended, by Pub. L. 111–148, title
I, § 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
PRIOR PROVISIONS
A prior section 2723 of act July 1, 1944, was renumbered section 2724 and is classified to section 300gg–23 of
this title.
AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–148, § 1563(c)(13)(A)(i),
formerly § 1562(c)(13)(A)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘individual or group
market’’ for ‘‘small or large group markets’’.
Subsec. (a)(2). Pub. L. 111–148, § 1563(c)(13)(a)(ii), formerly § 1562(c)(13)(A)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), inserted ‘‘or individual health insurance coverage’’ after ‘‘group health plans’’.
Subsec. (b)(1)(B). Pub. L. 111–148, § 1563(c)(13)(B), formerly § 1562(c)(13)(B), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), inserted ‘‘individual health insurance coverage or’’ after ‘‘with respect to’’.
2008—Subsec. (b)(3). Pub. L. 110–233 added par. (3).
EFFECTIVE DATE OF 2008 AMENDMENT
Amendment by Pub. L. 110–233 applicable, with respect to group health plans and health insurance coverage offered in connection with group health plans, for
plan years beginning after the date that is one year
after May 21, 2008, and, with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market, after the date that is
one year after May 21, 2008, see section 102(d)(2) of Pub.

Page 1318

L. 110–233, set out as a note under section 300gg–21 of
this title.
EFFECTIVE DATE
Section applicable with respect to group health
plans, and health insurance coverage offered in connection with group health plans, for plan years beginning
after June 30, 1997, except as otherwise provided, see
section 102(c) of Pub. L. 104–191, set out as a note under
section 300gg of this title.

§ 300gg–23. Preemption; State flexibility; construction
(a) Continued applicability of State law with respect to health insurance issuers
(1) In general
Subject to paragraph (2) and except as provided in subsection (b) of this section, this
part and part C of this subchapter insofar as it
relates to this part shall not be construed to
supersede any provision of State law which establishes, implements, or continues in effect
any standard or requirement solely relating to
health insurance issuers in connection with
individual or group health insurance coverage
except to the extent that such standard or requirement prevents the application of a requirement of this part.
(2) Continued preemption with respect to
group health plans
Nothing in this part shall be construed to affect or modify the provisions of section 1144 of
title 29 with respect to group health plans.
(b) Special rules in case of portability requirements
(1) In general
Subject to paragraph (2), the provisions of
this part relating to health insurance coverage
offered by a health insurance issuer supersede
any provision of State law which establishes,
implements, or continues in effect a standard
or requirement applicable to imposition of a
preexisting condition exclusion specifically
governed by section 701 1 which differs from
the standards or requirements specified in
such section.
(2) Exceptions
Only in relation to health insurance coverage offered by a health insurance issuer, the
provisions of this part do not supersede any
provision of State law to the extent that such
provision—
(i) substitutes for the reference to ‘‘6month period’’ in section 2701(a)(1) 1 a reference to any shorter period of time;
(ii) substitutes for the reference to ‘‘12
months’’ and ‘‘18 months’’ in section
2701(a)(2) 1 a reference to any shorter period
of time;
(iii) substitutes for the references to ‘‘63’’
and
days
in
sections
2701(c)(2)(A) 1
2701(d)(4)(A) 1 a reference to any greater
number of days;
(iv) substitutes for the reference to ‘‘30day period’’ in sections 2701(b)(2) 1 and
2701(d)(1) 1 a reference to any greater period;
1 See

References in Text note below.

Page 1319

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(v) prohibits the imposition of any preexisting condition exclusion in cases not described in section 2701(d) 1 or expands the exceptions described in such section;
(vi) requires special enrollment periods in
addition to those required under section
2701(f) 1; or
(vii) reduces the maximum period permitted in an affiliation period under section
2701(g)(1)(B) 1.
(c) Rules of construction
Nothing in this part (other than section 2704) 1
shall be construed as requiring a group health
plan or health insurance coverage to provide
specific benefits under the terms of such plan or
coverage.
(d) Definitions
For purposes of this section—
(1) State law
The term ‘‘State law’’ includes all laws, decisions, rules, regulations, or other State action having the effect of law, of any State. A
law of the United States applicable only to the
District of Columbia shall be treated as a
State law rather than a law of the United
States.
(2) State
The term ‘‘State’’ includes a State (including the Northern Mariana Islands), any political subdivisions of a State or such Islands, or
any agency or instrumentality of either.
(July 1, 1944, ch. 373, title XXVII, § 2724, formerly
§ 2723, as added Pub. L. 104–191, title I, § 102(a),
Aug. 21, 1996, 110 Stat. 1971; amended Pub. L.
104–204, title VI, § 604(b)(2), Sept. 26, 1996, 110
Stat. 2941; renumbered § 2737, renumbered § 2724,
and amended Pub. L. 111–148, title I, §§ 1001(4),
1563(c)(14),
formerly
§ 1562(c)(14),
title
X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.)
REFERENCES IN TEXT
Section 2701, referred to in subsec. (b), is a reference
to section 2701 of act July 1, 1944. Section 2701, which
was classified to section 300gg of this title, was renumbered section 2704, effective for plan years beginning on
or after Jan. 1, 2014, with certain exceptions, and
amended, by Pub. L. 111–148, title I, §§ 1201(2), 1563(c)(1),
formerly § 1562(c)(1), title X, § 10107(b)(1), Mar. 23, 2010,
124 Stat. 154, 264, 911, and was transferred to section
300gg–3 of this title. A new section 2701 of act July 1,
1944, related to fair health insurance premiums, was
added, effective for plan years beginning on or after
Jan. 1, 2014, and amended, by Pub. L. 111–148, title I,
§ 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
Section 701, referred to in subsec. (b)(1), probably
means ‘‘section 2701’’ of act July 1, 1944. See note above.
Section 2704, referred to in subsec. (c), is a reference
to section 2704 of act July 1, 1944. Section 2704, which
was classified to section 300gg–4 of this title, was renumbered section 2725, and amended by Pub. L. 111–148,
title I, §§ 1001(2), 1563(c)(3), formerly § 1562(c)(3), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 911, and was
transferred to section 300gg–25 of this title. A new section 2704 of act July 1, 1944, related to prohibition of
preexisting condition exclusions or other discrimination based on health status, was added, effective for
plan years beginning on or after Jan. 1, 2014, with certain exceptions, and amended, by Pub. L. 111–148, title
I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911, and is
classified to section 300gg–3 of this title.

§ 300gg–25

AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–148, § 1563(c)(14)(A),
formerly § 1562(c)(14)(A), as renumbered by Pub. L.
111–148, § 10107(b)(1), inserted ‘‘individual or’’ before
‘‘group health insurance’’.
1996—Subsec. (c). Pub. L. 104–204 inserted ‘‘(other
than section 2704)’’ after ‘‘part’’.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–204 applicable with respect to group health plans for plan years beginning on
or after Jan. 1, 1998, see section 604(c) of Pub. L. 104–204
set out as an Effective Date note under section 300gg–25
of this title.
EFFECTIVE DATE
Section applicable with respect to group health
plans, and health insurance coverage offered in connection with group health plans, for plan years beginning
after June 30, 1997, except as otherwise provided, see
section 102(c) of Pub. L. 104–191, set out as a note under
section 300gg of this title.

§ 300gg–25. Standards relating to benefits for
mothers and newborns
(a) Requirements for minimum hospital stay following birth
(1) In general
A group health plan, and a health insurance
issuer offering group or individual health insurance coverage, may not—
(A) except as provided in paragraph (2)—
(i) restrict benefits for any hospital
length of stay in connection with childbirth for the mother or newborn child, following a normal vaginal delivery, to less
than 48 hours, or
(ii) restrict benefits for any hospital
length of stay in connection with childbirth for the mother or newborn child, following a cesarean section, to less than 96
hours, or
(B) require that a provider obtain authorization from the plan or the issuer for prescribing any length of stay required under
subparagraph (A) (without regard to paragraph (2)).
(2) Exception
Paragraph (1)(A) shall not apply in connection with any group health plan or health insurance issuer in any case in which the decision to discharge the mother or her newborn
child prior to the expiration of the minimum
length of stay otherwise required under paragraph (1)(A) is made by an attending provider
in consultation with the mother.
(b) Prohibitions
A group health plan, and a health insurance issuer offering group or individual health insurance coverage, may not—
(1) deny to the mother or her newborn child
eligibility, or continued eligibility, to enroll
or to renew coverage under the terms of the
plan or coverage, solely for the purpose of
avoiding the requirements of this section;
(2) provide monetary payments or rebates to
mothers to encourage such mothers to accept
less than the minimum protections available
under this section;
(3) penalize or otherwise reduce or limit the
reimbursement of an attending provider be-

§ 300gg–25

TITLE 42—THE PUBLIC HEALTH AND WELFARE

cause such provider provided care to an individual participant or beneficiary in accordance with this section;
(4) provide incentives (monetary or otherwise) to an attending provider to induce such
provider to provide care to an individual participant or beneficiary in a manner inconsistent with this section; or
(5) subject to subsection (c)(3) of this section, restrict benefits for any portion of a period within a hospital length of stay required
under subsection (a) of this section in a manner which is less favorable than the benefits
provided for any preceding portion of such
stay.
(c) Rules of construction
(1) Nothing in this section shall be construed
to require a mother who is a participant or beneficiary—
(A) to give birth in a hospital; or
(B) to stay in the hospital for a fixed period
of time following the birth of her child.
(2) This section shall not apply with respect to
any group health plan, or any health insurance
issuer offering group or individual health insurance coverage, which does not provide benefits
for hospital lengths of stay in connection with
childbirth for a mother or her newborn child.
(3) Nothing in this section shall be construed
as preventing a group health plan or health insurance issuer from imposing deductibles, coinsurance, or other cost-sharing in relation to
benefits for hospital lengths of stay in connection with childbirth for a mother or newborn
child under the plan (or under health insurance
coverage offered in connection with a group
health plan), except that such coinsurance or
other cost-sharing for any portion of a period
within a hospital length of stay required under
subsection (a) of this section may not be greater
than such coinsurance or cost-sharing for any
preceding portion of such stay.
(d) Notice
A group health plan under this part shall comply with the notice requirement under section
1185(d) of title 29 with respect to the requirements of this section as if such section applied
to such plan.
(e) Level and type of reimbursements
Nothing in this section shall be construed to
prevent a group health plan or a health insurance issuer offering group or individual health
insurance coverage from negotiating the level
and type of reimbursement with a provider for
care provided in accordance with this section.
(f) Preemption; exception for health insurance
coverage in certain States
(1) In general
The requirements of this section shall not
apply with respect to health insurance coverage if there is a State law (as defined in section 300gg–23(d)(1) 1 of this title) for a State
that regulates such coverage that is described
in any of the following subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital
1 See

References in Text note below.

Page 1320

length of stay following a normal vaginal delivery and at least a 96-hour hospital length
of stay following a cesarean section.
(B) Such State law requires such coverage
to provide for maternity and pediatric care
in accordance with guidelines established by
the American College of Obstetricians and
Gynecologists, the American Academy of
Pediatrics, or other established professional
medical associations.
(C) Such State law requires, in connection
with such coverage for maternity care, that
the hospital length of stay for such care is
left to the decision of (or required to be
made by) the attending provider in consultation with the mother.
(2) Construction
Section 300gg–23(a)(1) 1 of this title shall not
be construed as superseding a State law described in paragraph (1).
(July 1, 1944, ch. 373, title XXVII, § 2725, formerly
§ 2704, as added Pub. L. 104–204, title VI,
§ 604(a)(3), Sept. 26, 1996, 110 Stat. 2939; renumbered § 2725 and amended Pub. L. 111–148, title I,
§§ 1001(2), 1563(c)(3), formerly § 1562(c)(3), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 911.)
REFERENCES IN TEXT
Section 300gg–23 of this title, referred to in subsec.
(f), was in the original section ‘‘2723’’, and was translated as meaning section 2724 of act July 1, 1944, to reflect the probable intent of Congress and the renumbering of section 2723 as 2724 by Pub. L. 111–148, title I,
§§ 1001(4), 1563(c)(14)(B), formerly § 1562(c)(14)(B), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.
CODIFICATION
Section was formerly classified to section 300gg–4 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Subsec. (a)(1). Pub. L. 111–148, § 1563(c)(3)(A), formerly § 1562(c)(3)(A), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘group or individual health insurance coverage’’ for ‘‘group health insurance coverage’’ in introductory provisions.
Subsec. (b). Pub. L. 111–148, § 1563(c)(3)(B)(i), formerly
§ 1562(c)(3)(B)(i), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘group or individual health insurance coverage’’ for ‘‘group health insurance coverage in connection with a group health plan’’ in introductory provisions.
Subsec. (b)(1). Pub. L. 111–148, § 1563(c)(3)(B)(ii), formerly § 1562(c)(3)(B)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘plan or coverage’’ for
‘‘plan’’.
Subsec. (c)(2). Pub. L. 111–148, § 1563(c)(3)(C)(i), formerly § 1562(c)(3)(C)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘health insurance issuer offering group or individual health insurance coverage’’ for ‘‘group health insurance coverage offered by
a health insurance issuer’’.
Subsec. (c)(3). Pub. L. 111–148, § 1563(c)(3)(C)(ii), formerly § 1562(c)(3)(C)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘health insurance issuer’’ for ‘‘issuer’’.
Subsec. (e). Pub. L. 111–148, § 1563(c)(3)(D), formerly
§ 1562(c)(3)(D), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘group or individual health insurance coverage’’ for ‘‘group health insurance coverage’’.
EFFECTIVE DATE
Section 604(c) of Pub. L. 104–204 provided that: ‘‘The
amendments made by this section [enacting this sec-

Page 1321

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tion and amending sections 300gg–21 and 300gg–23 of this
title] shall apply with respect to group health plans for
plan years beginning on or after January 1, 1998.’’
CONGRESSIONAL FINDINGS
Section 602 of title VI of Pub. L. 104–204 provided
that: ‘‘Congress finds that—
‘‘(1) the length of post-delivery hospital stay should
be based on the unique characteristics of each mother
and her newborn child, taking into consideration the
health of the mother, the health and stability of the
newborn, the ability and confidence of the mother
and the father to care for their newborn, the adequacy of support systems at home, and the access of
the mother and her newborn to appropriate follow-up
health care; and
‘‘(2) the timing of the discharge of a mother and her
newborn child from the hospital should be made by
the attending provider in consultation with the
mother.’’

§ 300gg–26. Parity in mental health and substance use disorder benefits
(a) In general
(1) Aggregate lifetime limits
In the case of a group health plan or a health
insurance issuer offering group or individual
health insurance coverage that provides both
medical and surgical benefits and mental
health or substance use disorder benefits—
(A) No lifetime limit
If the plan or coverage does not include an
aggregate lifetime limit on substantially all
medical and surgical benefits, the plan or
coverage may not impose any aggregate lifetime limit on mental health or substance
use disorder benefits.
(B) Lifetime limit
If the plan or coverage includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph
referred to as the ‘‘applicable lifetime
limit’’), the plan or coverage shall either—
(i) apply the applicable lifetime limit
both to the medical and surgical benefits
to which it otherwise would apply and to
mental health and substance use disorder
benefits and not distinguish in the application of such limit between such medical
and surgical benefits and mental health
and substance use disorder benefits; or
(ii) not include any aggregate lifetime
limit on mental health or substance use
disorder benefits that is less than the applicable lifetime limit.
(C) Rule in case of different limits
In the case of a plan or coverage that is
not described in subparagraph (A) or (B) and
that includes no or different aggregate lifetime limits on different categories of medical and surgical benefits, the Secretary shall
establish rules under which subparagraph (B)
is applied to such plan or coverage with respect to mental health and substance use
disorder benefits by substituting for the applicable lifetime limit an average aggregate
lifetime limit that is computed taking into
account the weighted average of the aggregate lifetime limits applicable to such categories.

§ 300gg–26

(2) Annual limits
In the case of a group health plan or a health
insurance issuer offering group or individual
health insurance coverage that provides both
medical and surgical benefits and mental
health or substance use disorder benefits—
(A) No annual limit
If the plan or coverage does not include an
annual limit on substantially all medical
and surgical benefits, the plan or coverage
may not impose any annual limit on mental
health or substance use disorder benefits.
(B) Annual limit
If the plan or coverage includes an annual
limit on substantially all medical and surgical benefits (in this paragraph referred to
as the ‘‘applicable annual limit’’), the plan
or coverage shall either—
(i) apply the applicable annual limit
both to medical and surgical benefits to
which it otherwise would apply and to
mental health and substance use disorder
benefits and not distinguish in the application of such limit between such medical
and surgical benefits and mental health
and substance use disorder benefits; or
(ii) not include any annual limit on mental health or substance use disorder benefits that is less than the applicable annual
limit.
(C) Rule in case of different limits
In the case of a plan or coverage that is
not described in subparagraph (A) or (B) and
that includes no or different annual limits
on different categories of medical and surgical benefits, the Secretary shall establish
rules under which subparagraph (B) is applied to such plan or coverage with respect
to mental health and substance use disorder
benefits by substituting for the applicable
annual limit an average annual limit that is
computed taking into account the weighted
average of the annual limits applicable to
such categories.
(3) Financial requirements and treatment limitations
(A) In general
In the case of a group health plan or a
health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and
mental health or substance use disorder benefits, such plan or coverage shall ensure
that—
(i) the financial requirements applicable
to such mental health or substance use
disorder benefits are no more restrictive
than the predominant financial requirements applied to substantially all medical
and surgical benefits covered by the plan
(or coverage), and there are no separate
cost sharing requirements that are applicable only with respect to mental health
or substance use disorder benefits; and
(ii) the treatment limitations applicable
to such mental health or substance use
disorder benefits are no more restrictive
than the predominant treatment limita-

§ 300gg–26

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tions applied to substantially all medical
and surgical benefits covered by the plan
(or coverage) and there are no separate
treatment limitations that are applicable
only with respect to mental health or substance use disorder benefits.
(B) Definitions
In this paragraph:
(i) Financial requirement
The term ‘‘financial requirement’’ includes deductibles, copayments, coinsurance, and out-of-pocket expenses, but excludes an aggregate lifetime limit and an
annual limit subject to paragraphs (1) and
(2).
(ii) Predominant
A financial requirement or treatment
limit is considered to be predominant if it
is the most common or frequent of such
type of limit or requirement.
(iii) Treatment limitation
The term ‘‘treatment limitation’’ includes limits on the frequency of treatment, number of visits, days of coverage,
or other similar limits on the scope or duration of treatment.
(4) Availability of plan information
The criteria for medical necessity determinations made under the plan with respect to
mental health or substance use disorder benefits (or the health insurance coverage offered
in connection with the plan with respect to
such benefits) shall be made available by the
plan administrator (or the health insurance issuer offering such coverage) in accordance
with regulations to any current or potential
participant, beneficiary, or contracting provider upon request. The reason for any denial
under the plan (or coverage) of reimbursement
or payment for services with respect to mental
health or substance use disorder benefits in
the case of any participant or beneficiary
shall, on request or as otherwise required, be
made available by the plan administrator (or
the health insurance issuer offering such coverage) to the participant or beneficiary in accordance with regulations.
(5) Out-of-network providers
In the case of a plan or coverage that provides both medical and surgical benefits and
mental health or substance use disorder benefits, if the plan or coverage provides coverage
for medical or surgical benefits provided by
out-of-network providers, the plan or coverage
shall provide coverage for mental health or
substance use disorder benefits provided by
out-of-network providers in a manner that is
consistent with the requirements of this section.
(b) Construction
Nothing in this section shall be construed—
(1) as requiring a group health plan or a
health insurance issuer offering group or individual health insurance coverage to provide
any mental health or substance use disorder
benefits; or

Page 1322

(2) in the case of a group health plan or a
health insurance issuer offering group or individual health insurance coverage that provides
mental health or substance use disorder benefits, as affecting the terms and conditions of
the plan or coverage relating to such benefits
under the plan or coverage, except as provided
in subsection (a).
(c) Exemptions
(1) Small employer exemption
This section shall not apply to any group
health plan and a health insurance issuer offering group or individual health insurance
coverage for any plan year of a small employer
(as defined in section 300gg–91(e)(4) of this
title, except that for purposes of this paragraph such term shall include employers with
1 employee in the case of an employer residing
in a State that permits small groups to include a single individual).
(2) Cost exemption
(A) In general
With respect to a group health plan or a
health insurance issuer offering group or individual health insurance coverage, if the
application of this section to such plan (or
coverage) results in an increase for the plan
year involved of the actual total costs of
coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan
(as determined and certified under subparagraph (C)) by an amount that exceeds the applicable percentage described in subparagraph (B) of the actual total plan costs, the
provisions of this section shall not apply to
such plan (or coverage) during the following
plan year, and such exemption shall apply to
the plan (or coverage) for 1 plan year. An
employer may elect to continue to apply
mental health and substance use disorder
parity pursuant to this section with respect
to the group health plan (or coverage) involved regardless of any increase in total
costs.
(B) Applicable percentage
With respect to a plan (or coverage), the
applicable percentage described in this subparagraph shall be—
(i) 2 percent in the case of the first plan
year in which this section is applied; and
(ii) 1 percent in the case of each subsequent plan year.
(C) Determinations by actuaries
Determinations as to increases in actual
costs under a plan (or coverage) for purposes
of this section shall be made and certified by
a qualified and licensed actuary who is a
member in good standing of the American
Academy of Actuaries. All such determinations shall be in a written report prepared by
the actuary. The report, and all underlying
documentation relied upon by the actuary,
shall be maintained by the group health plan
or health insurance issuer for a period of 6
years following the notification made under
subparagraph (E).

Page 1323

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(D) 6-month determinations
If a group health plan (or a health insurance issuer offering coverage in connection
with a group health plan) seeks an exemption under this paragraph, determinations
under subparagraph (A) shall be made after
such plan (or coverage) has complied with
this section for the first 6 months of the plan
year involved.
(E) Notification
(i) In general
A group health plan (or a health insurance issuer offering coverage in connection
with a group health plan) that, based upon
a certification described under subparagraph (C), qualifies for an exemption under
this paragraph, and elects to implement
the exemption, shall promptly notify the
Secretary, the appropriate State agencies,
and participants and beneficiaries in the
plan of such election.
(ii) Requirement
A notification to the Secretary under
clause (i) shall include—
(I) a description of the number of covered lives under the plan (or coverage)
involved at the time of the notification,
and as applicable, at the time of any
prior election of the cost-exemption
under this paragraph by such plan (or
coverage);
(II) for both the plan year upon which
a cost exemption is sought and the year
prior, a description of the actual total
costs of coverage with respect to medical
and surgical benefits and mental health
and substance use disorder benefits
under the plan; and
(III) for both the plan year upon which
a cost exemption is sought and the year
prior, the actual total costs of coverage
with respect to mental health and substance use disorder benefits under the
plan.
(iii) Confidentiality
A notification to the Secretary under
clause (i) shall be confidential. The Secretary shall make available, upon request
and on not more than an annual basis, an
anonymous itemization of such notifications, that includes—
(I) a breakdown of States by the size
and type of employers submitting such
notification; and
(II) a summary of the data received
under clause (ii).
(F) Audits by appropriate agencies
To determine compliance with this paragraph, the Secretary may audit the books
and records of a group health plan or health
insurance issuer relating to an exemption,
including any actuarial reports prepared
pursuant to subparagraph (C), during the 6
year period following the notification of
such exemption under subparagraph (E). A
State agency receiving a notification under
subparagraph (E) may also conduct such an
audit with respect to an exemption covered
by such notification.

§ 300gg–26

(d) Separate application to each option offered
In the case of a group health plan that offers
a participant or beneficiary two or more benefit
package options under the plan, the requirements of this section shall be applied separately
with respect to each such option.
(e) Definitions
For purposes of this section—
(1) Aggregate lifetime limit
The term ‘‘aggregate lifetime limit’’ means,
with respect to benefits under a group health
plan or health insurance coverage, a dollar
limitation on the total amount that may be
paid with respect to such benefits under the
plan or health insurance coverage with respect
to an individual or other coverage unit.
(2) Annual limit
The term ‘‘annual limit’’ means, with respect to benefits under a group health plan or
health insurance coverage, a dollar limitation
on the total amount of benefits that may be
paid with respect to such benefits in a 12month period under the plan or health insurance coverage with respect to an individual or
other coverage unit.
(3) Medical or surgical benefits
The term ‘‘medical or surgical benefits’’
means benefits with respect to medical or surgical services, as defined under the terms of
the plan or coverage (as the case may be), but
does not include mental health or substance
use disorder benefits.
(4) Mental health benefits
The term ‘‘mental health benefits’’ means
benefits with respect to services for mental
health conditions, as defined under the terms
of the plan and in accordance with applicable
Federal and State law.
(5) Substance use disorder benefits
The term ‘‘substance use disorder benefits’’
means benefits with respect to services for
substance use disorders, as defined under the
terms of the plan and in accordance with applicable Federal and State law.
(July 1, 1944, ch. 373, title XXVII, § 2726, formerly
§ 2705, as added Pub. L. 104–204, title VII, § 703(a),
Sept. 26, 1996, 110 Stat. 2947; amended Pub. L.
107–116, title VII, § 701(b), Jan. 10, 2002, 115 Stat.
2228; Pub. L. 107–313, § 2(b), Dec. 2, 2002, 116 Stat.
2457; Pub. L. 108–197, § 2(b), Dec. 19, 2003, 117 Stat.
2898; Pub. L. 108–311, title III, § 302(c), Oct. 4, 2004,
118 Stat. 1179; Pub. L. 109–151, § 1(b), Dec. 30, 2005,
119 Stat. 2886; Pub. L. 109–432, div. A, title I,
§ 115(c), Dec. 20, 2006, 120 Stat. 2941; Pub. L.
110–245, title IV, § 401(c), June 17, 2008, 122 Stat.
1650; Pub. L. 110–343, div. C, title V, § 512(b),
(g)(2), Oct. 3, 2008, 122 Stat. 3885, 3892; renumbered § 2726 and amended Pub. L. 111–148, title I,
§§ 1001(2), 1563(c)(4), formerly § 1562(c)(4), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 911.)
CODIFICATION
Section was formerly classified to section 300gg–5 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Subsecs. (a), (b). Pub. L. 111–148, § 1563(c)(4)(A),
(B), formerly § 1562(c)(4)(A), (B), as renumbered by Pub.

§ 300gg–26

TITLE 42—THE PUBLIC HEALTH AND WELFARE

L. 111–148, § 10107(b)(1), substituted ‘‘or a health insurance issuer offering group or individual health insurance coverage’’ for ‘‘(or health insurance coverage offered in connection with such a plan)’’ wherever appearing.
Subsec. (c)(1). Pub. L. 111–148, § 1563(c)(4)(C)(i), formerly § 1562(c)(4)(C)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘and a health insurance issuer offering group or individual health insurance coverage’’ for ‘‘(and group health insurance coverage offered in connection with a group health plan)’’.
Subsec. (c)(2)(A). Pub. L. 111–148, § 1563(c)(4)(C)(ii), formerly § 1562(c)(4)(C)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘or a health insurance
issuer offering group or individual health insurance
coverage’’ for ‘‘(or health insurance coverage offered in
connection with such a plan)’’.
2008—Pub. L. 110–343, § 512(g)(2), amended section
catchline generally. Prior to amendment, catchline
read as follows: ‘‘Parity in application of certain limits
to mental health benefits’’.
Subsec. (a)(1), (2). Pub. L. 110–343, § 512(b)(7), substituted ‘‘mental health or substance use disorder benefits’’ for ‘‘mental health benefits’’ wherever appearing
in pars. (1)(introductory provisions), (A), and (B)(ii) and
(2)(introductory provisions), (A), and (B)(ii).
Pub. L. 110–343, § 512(b)(6), substituted ‘‘mental health
and substance use disorder benefits’’ for ‘‘mental
health benefits’’ wherever appearing in pars. (1)(B)(i)
and (C) and (2)(B)(i) and (C).
Subsec. (a)(3) to (5). Pub. L. 110–343, § 512(b)(1), added
pars. (3) to (5).
Subsec. (b)(1). Pub. L. 110–343, § 512(b)(7), substituted
‘‘mental health or substance use disorder benefits’’ for
‘‘mental health benefits’’.
Subsec. (b)(2). Pub. L. 110–343, § 512(b)(2), amended par.
(2) generally. Prior to amendment, par. (2) read as follows: ‘‘in the case of a group health plan (or health insurance coverage offered in connection with such a
plan) that provides mental health benefits, as affecting
the terms and conditions (including cost sharing, limits
on numbers of visits or days of coverage, and requirements relating to medical necessity) relating to the
amount, duration, or scope of mental health benefits
under the plan or coverage, except as specifically provided in subsection (a) of this section (in regard to parity in the imposition of aggregate lifetime limits and
annual limits for mental health benefits).’’
Subsec. (c)(1). Pub. L. 110–343, § 512(b)(3)(A), inserted
‘‘(as defined in section 300gg–91(e)(4) of this title, except
that for purposes of this paragraph such term shall include employers with 1 employee in the case of an employer residing in a State that permits small groups to
include a single individual)’’ before period at end.
Subsec. (c)(2). Pub. L. 110–343, § 512(b)(3)(B), added par.
(2) and struck out former par. (2). Prior to amendment,
text read as follows: ‘‘This section shall not apply with
respect to a group health plan (or health insurance coverage offered in connection with a group health plan) if
the application of this section to such plan (or to such
coverage) results in an increase in the cost under the
plan (or for such coverage) of at least 1 percent.’’
Subsec. (e)(3). Pub. L. 110–343, § 512(b)(7), substituted
‘‘mental health or substance use disorder benefits’’ for
‘‘mental health benefits’’.
Subsec. (e)(4). Pub. L. 110–343, § 512(b)(7), which directed substitution of ‘‘mental health or substance use
disorder benefits’’ for ‘‘mental health benefits’’ wherever appearing in this section (other than in any provision amended by section 512(b)(6) of Pub. L. 110–343),
was not executed to par. (4) as added by Pub. L. 110–343,
§ 512(b)(4), to reflect the probable intent of Congress.
See below.
Pub. L. 110–343, § 512(b)(4), added par. (4) and struck
out former par. (4). Prior to amendment, text read as
follows: ‘‘The term ‘mental health benefits’ means benefits with respect to mental health services, as defined
under the terms of the plan or coverage (as the case
may be), but does not include benefits with respect to
treatment of substance abuse or chemical dependency.’’

Page 1324

Subsec. (e)(5). Pub. L. 110–343, § 512(b)(4), added par.
(5).
Subsec. (f). Pub. L. 110–343, § 512(b)(5), struck out subsec. (f). Text read as follows: ‘‘This section shall not
apply to benefits for services furnished—
‘‘(1) on or after January 1, 2008, and before June 17,
2008, and
‘‘(2) after December 31, 2008..’’
Pub. L. 110–245 substituted ‘‘services furnished—’’ for
‘‘services furnished after December 31, 2007’’ and added
pars. (1) and (2).
2006—Subsec. (f). Pub. L. 109–432 substituted ‘‘2007’’
for ‘‘2006’’.
2005—Subsec. (f). Pub. L. 109–151 substituted ‘‘December 31, 2006’’ for ‘‘December 31, 2005’’.
2004—Subsec. (f). Pub. L. 108–311 substituted ‘‘after
December 31, 2005’’ for ‘‘on or after December 31, 2004’’.
2003—Subsec. (f). Pub. L. 108–197 substituted ‘‘December 31, 2004’’ for ‘‘December 31, 2003’’.
2002—Subsec. (f). Pub. L. 107–313 substituted ‘‘December 31, 2003’’ for ‘‘December 31, 2002’’.
Pub. L. 107–116 substituted ‘‘December 31, 2002’’ for
‘‘September 30, 2001’’.
EFFECTIVE DATE OF 2008 AMENDMENT
Pub. L. 110–343, div. C, title V, § 512(e), Oct. 3, 2008, 122
Stat. 3891, as amended by Pub. L. 110–460, § 1, Dec. 23,
2008, 122 Stat. 5123, provided that:
‘‘(1) IN GENERAL.—The amendments made by this section [amending this section, section 9812 of Title 26, Internal Revenue Code, and section 1185a of Title 29,
Labor] shall apply with respect to group health plans
for plan years beginning after the date that is 1 year
after the date of enactment of this Act [Oct. 3, 2008], regardless of whether regulations have been issued to
carry out such amendments by such effective date, except that the amendments made by subsections (a)(5),
(b)(5), and (c)(5) [amending this section, section 9812 of
Title 26, and section 1185a of Title 29], relating to striking of certain sunset provisions, shall take effect on
January 1, 2009.
‘‘(2) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group health plan maintained
pursuant to one or more collective bargaining agreements between employee representatives and one or
more employers ratified before the date of the enactment of this Act [Oct. 3, 2008], the amendments made
by this section shall not apply to plan years beginning
before the later of—
‘‘(A) the date on which the last of the collective
bargaining agreements relating to the plan terminates (determined without regard to any extension
thereof agreed to after the date of the enactment of
this Act), or
‘‘(B) January 1, 2010.
For purposes of subparagraph (A), any plan amendment
made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this section shall
not be treated as a termination of such collective bargaining agreement.’’
EFFECTIVE DATE
Section 703(b) of Pub. L. 104–204 provided that: ‘‘The
amendments made by this section [enacting this section] shall apply with respect to group health plans for
plan years beginning on or after January 1, 1998.’’
REGULATIONS
Pub. L. 110–343, div. C, title V, § 512(d), Oct. 3, 2008, 122
Stat. 3891, provided that: ‘‘Not later than 1 year after
the date of enactment of this Act [Oct. 3, 2008], the Secretaries of Labor, Health and Human Services, and the
Treasury shall issue regulations to carry out the
amendments made by subsections (a), (b), and (c)
[amending this section, section 9812 of Title 26, Internal
Revenue Code, and section 1185a of Title 29, Labor], respectively.’’
ASSURING COORDINATION
Pub. L. 110–343, div. C, title V, § 512(f), Oct. 3, 2008, 122
Stat. 3892, provided that: ‘‘The Secretary of Health and

Page 1325

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Human Services, the Secretary of Labor, and the Secretary of the Treasury may ensure, through the execution or revision of an interagency memorandum of understanding among such Secretaries, that—
‘‘(1) regulations, rulings, and interpretations issued
by such Secretaries relating to the same matter over
which two or more such Secretaries have responsibility under this section [amending this section, section
9812 of Title 26, Internal Revenue Code, and section
1185a of Title 29, Labor, and enacting provisions set
out as notes under this section] (and the amendments
made by this section) are administered so as to have
the same effect at all times; and
‘‘(2) coordination of policies relating to enforcing
the same requirements through such Secretaries in
order to have a coordinated enforcement strategy
that avoids duplication of enforcement efforts and assigns priorities in enforcement.’’

§ 300gg–27. Required coverage for reconstructive
surgery following mastectomies
The provisions of section 1185b of title 29 shall
apply to group health plans, and and 1 health insurance issuers offering group or individual
health insurance coverage, as if included in this
subpart.
(July 1, 1944, ch. 373, title XXVII, § 2727, formerly
§ 2706, as added Pub. L. 105–277, div. A, § 101(f)
[title IX, § 903(a)], Oct. 21, 1998, 112 Stat. 2681–337,
2681–438; renumbered § 2727 and amended Pub. L.
111–148, title I, §§ 1001(2), 1563(c)(5), formerly
§ 1562(c)(5), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 130, 266, 911.)
CODIFICATION
Section was formerly classified to section 300gg–6 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Pub. L. 111–148, § 1563(c)(5), formerly § 1562(c)(5),
as renumbered by Pub. L. 111–148, § 10107(b)(1), substituted ‘‘and health insurance issuers offering group or
individual health insurance coverage’’ for ‘‘health insurance issuers providing health insurance coverage in
connection with group health plans’’.
EFFECTIVE DATE
Pub. L. 105–277, div. A, § 101(f) [title IX, § 903(c)(1)],
Oct. 21, 1998, 112 Stat. 2681–337, 2681–438, provided that:
‘‘(A) IN GENERAL.—The amendment made by subsection (a) [enacting this section] shall apply to group
health plans for plan years beginning on or after the
date of enactment of this Act [Oct. 21, 1998].
‘‘(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group health plan maintained
pursuant to 1 or more collective bargaining agreements
between employee representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining agreement relating to the plan
which amends the plan solely to conform to any requirement added by the amendment made by subsection (a) shall not be treated as a termination of such
collective bargaining agreement.’’

§ 300gg–28. Coverage of dependent students on
medically necessary leave of absence
(a) Medically necessary leave of absence
In this section, the term ‘‘medically necessary
leave of absence’’ means, with respect to a dependent child described in subsection (b)(2) in
connection with a group health plan or individual health insurance coverage, a leave of ab1 So

in original.

§ 300gg–28

sence of such child from a postsecondary educational institution (including an institution of
higher education as defined in section 1002 of
title 20), or any other change in enrollment of
such child at such an institution, that—
(1) commences while such child is suffering
from a serious illness or injury;
(2) is medically necessary; and
(3) causes such child to lose student status
for purposes of coverage under the terms of
the plan or coverage.
(b) Requirement to continue coverage
(1) In general
In the case of a dependent child described in
paragraph (2), a group health plan, or a health
insurance issuer that offers group or individual health insurance coverage, shall not terminate coverage of such child under such plan
or health insurance coverage due to a medically necessary leave of absence before the
date that is the earlier of—
(A) the date that is 1 year after the first
day of the medically necessary leave of absence; or
(B) the date on which such coverage would
otherwise terminate under the terms of the
plan or health insurance coverage.
(2) Dependent child described
A dependent child described in this paragraph is, with respect to a group health plan
or individual health insurance coverage, a beneficiary under the plan who—
(A) is a dependent child, under the terms
of the plan or coverage, of a participant or
beneficiary under the plan or coverage; and
(B) was enrolled in the plan or coverage,
on the basis of being a student at a postsecondary educational institution (as described in subsection (a)), immediately before the first day of the medically necessary
leave of absence involved.
(3) Certification by physician
Paragraph (1) shall apply to a group health
plan or individual health insurance coverage
only if the plan or issuer of the coverage has
received written certification by a treating
physician of the dependent child which states
that the child is suffering from a serious illness or injury and that the leave of absence (or
other change of enrollment) described in subsection (a) is medically necessary.
(c) Notice
A group health plan, and a health insurance issuer that offers group or individual health insurance coverage, shall include, with any notice regarding a requirement for certification of student status for coverage under the plan or coverage, a description of the terms of this section
for continued coverage during medically necessary leaves of absence. Such description shall
be in language which is understandable to the
typical plan participant.
(d) No change in benefits
A dependent child whose benefits are continued under this section shall be entitled to the
same benefits as if (during the medically necessary leave of absence) the child continued to

§ 300gg–41

TITLE 42—THE PUBLIC HEALTH AND WELFARE

be a covered student at the institution of higher
education and was not on a medically necessary
leave of absence.
(e) Continued application in case of changed coverage
If—
(1) a dependent child of a participant or beneficiary is in a period of coverage under a
group health plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child described
in subsection (b);
(2) the manner in which the participant or
beneficiary is covered under the plan changes,
whether through a change in health insurance
coverage or health insurance issuer, a change
between health insurance coverage and self-insured coverage, or otherwise; and
(3) the coverage as so changed continues to
provide coverage of beneficiaries as dependent
children,
this section shall apply to coverage of the child
under the changed coverage for the remainder of
the period of the medically necessary leave of
absence of the dependent child under the plan in
the same manner as it would have applied if the
changed coverage had been the previous coverage.
(July 1, 1944, ch. 373, title XXVII, § 2728, formerly
§ 2707, as added Pub. L. 110–381, § 2(b)(1), Oct. 9,
2008, 122 Stat. 4083; renumbered § 2728 and amended Pub. L. 111–148, title I, §§ 1001(2), 1563(c)(6), formerly § 1562(c)(6), title X, § 10107(b)(1), Mar. 23,
2010, 124 Stat. 130, 266, 911.)
CODIFICATION
Section was formerly classified to section 300gg–7 of
this title prior to renumbering by Pub. L. 111–148.
AMENDMENTS
2010—Subsec. (a). Pub. L. 111–148, § 1563(c)(6)(A), formerly § 1562(c)(6)(A), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘individual health insurance
coverage’’ for ‘‘health insurance coverage offered in
connection with such plan’’ in introductory provisions.
Subsec. (b)(1). Pub. L. 111–148, § 1563(c)(6)(B)(i), formerly § 1562(c)(6)(B)(i), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘or a health insurance
issuer that offers group or individual health insurance
coverage’’ for ‘‘or a health insurance issuer that provides health insurance coverage in connection with a
group health plan’’ in introductory provisions.
Subsec. (b)(2). Pub. L. 111–148, § 1563(c)(6)(B)(ii), formerly § 1562(c)(6)(B)(ii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘individual health insurance coverage’’ for ‘‘health insurance coverage offered in connection with the plan’’ in introductory provisions.
Subsec. (b)(3). Pub. L. 111–148, § 1563(c)(6)(B)(iii), formerly § 1562(c)(6)(B)(iii), as renumbered by Pub. L.
111–148, § 10107(b)(1), substituted ‘‘individual health insurance coverage’’ for ‘‘health insurance coverage offered by an issuer in connection with such plan’’.
Subsec. (c). Pub. L. 111–148, § 1563(c)(6)(C), formerly
§ 1562(c)(6)(C), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘health insurance issuer that
offers group or individual health insurance coverage’’
for ‘‘health insurance issuer providing health insurance
coverage in connection with a group health plan’’.
Subsec. (e)(1). Pub. L. 111–148, § 1563(c)(6)(D), formerly
§ 1562(c)(6)(D), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘individual health insurance
coverage’’ for ‘‘health insurance coverage offered in
connection with such a plan’’.

Page 1326

EFFECTIVE DATE
Section applicable with respect to plan years beginning on or after the date that is one year after Oct. 9,
2008, and to medically necessary leaves of absence beginning during such plan years, see section 2(d) of Pub.
L. 110–381, set out as a note under section 9813 of Title
26, Internal Revenue Code.

PART B—INDIVIDUAL MARKET RULES
SUBPART 1—PORTABILITY, ACCESS, AND
RENEWABILITY REQUIREMENTS

§ 300gg–41. Guaranteed availability of individual
health insurance coverage to certain individuals with prior group coverage
(a) Guaranteed availability
(1) In general
Subject to the succeeding subsections of this
section and section 300gg–44 of this title, each
health insurance issuer that offers health insurance coverage (as defined in section
300gg–91(b)(1) of this title) in the individual
market in a State may not, with respect to an
eligible individual (as defined in subsection (b)
of this section) desiring to enroll in individual
health insurance coverage—
(A) decline to offer such coverage to, or
deny enrollment of, such individual; or
(B) impose any preexisting condition exclusion (as defined in section 2701(b)(1)(A)) 1
with respect to such coverage.
(2) Substitution by State of acceptable alternative mechanism
The requirement of paragraph (1) shall not
apply to health insurance coverage offered in
the individual market in a State in which the
State is implementing an acceptable alternative mechanism under section 300gg–44 of
this title.
(b) ‘‘Eligible individual’’ defined
In this part, the term ‘‘eligible individual’’
means an individual—
(1)(A) for whom, as of the date on which the
individual seeks coverage under this section,
the aggregate of the periods of creditable coverage (as defined in section 2701(c)) 1 is 18 or
more months and (B) whose most recent prior
creditable coverage was under a group health
plan, governmental plan, or church plan (or
health insurance coverage offered in connection with any such plan);
(2) who is not eligible for coverage under (A)
a group health plan, (B) part A or part B of
title XVIII of the Social Security Act [42
U.S.C. 1395c et seq., 1395j et seq.], or (C) a
State plan under title XIX of such Act [42
U.S.C. 1396 et seq.] (or any successor program),
and does not have other health insurance coverage;
(3) with respect to whom the most recent
coverage within the coverage period described
in paragraph (1)(A) was not terminated based
on a factor described in paragraph (1) or (2) of
section 2712(b) 1 (relating to nonpayment of
premiums or fraud);
(4) if the individual had been offered the option of continuation coverage under a COBRA
1 See

References in Text note below.

Page 1327

TITLE 42—THE PUBLIC HEALTH AND WELFARE

continuation provision or under a similar
State program, who elected such coverage; and
(5) who, if the individual elected such continuation coverage, has exhausted such continuation coverage under such provision or
program.
(c) Alternative coverage permitted where no
State mechanism
(1) In general
In the case of health insurance coverage offered in the individual market in a State in
which the State is not implementing an acceptable alternative mechanism under section
300gg–44 of this title, the health insurance issuer may elect to limit the coverage offered
under subsection (a) of this section so long as
it offers at least two different policy forms of
health insurance coverage both of which—
(A) are designed for, made generally available to, and actively marketed to, and enroll
both eligible and other individuals by the issuer; and
(B) meet the requirement of paragraph (2)
or (3), as elected by the issuer.
For purposes of this subsection, policy forms
which have different cost-sharing arrangements or different riders shall be considered to
be different policy forms.
(2) Choice of most popular policy forms
The requirement of this paragraph is met,
for health insurance coverage policy forms offered by an issuer in the individual market, if
the issuer offers the policy forms for individual health insurance coverage with the largest, and next to largest, premium volume of
all such policy forms offered by the issuer in
the State or applicable marketing or service
area (as may be prescribed in regulation) by
the issuer in the individual market in the period involved.
(3) Choice of 2 policy forms with representative coverage
(A) In general
The requirement of this paragraph is met,
for health insurance coverage policy forms
offered by an issuer in the individual market, if the issuer offers a lower-level coverage policy form (as defined in subparagraph (B)) and a higher-level coverage policy
form (as defined in subparagraph (C)) each of
which includes benefits substantially similar
to other individual health insurance coverage offered by the issuer in that State and
each of which is covered under a method described in section 300gg–44(c)(3)(A) of this
title (relating to risk adjustment, risk
spreading, or financial subsidization).
(B) Lower-level of coverage described
A policy form is described in this subparagraph if the actuarial value of the benefits
under the coverage is at least 85 percent but
not greater than 100 percent of a weighted
average (described in subparagraph (D)).
(C) Higher-level of coverage described
A policy form is described in this subparagraph if—
(i) the actuarial value of the benefits
under the coverage is at least 15 percent

§ 300gg–41

greater than the actuarial value of the
coverage described in subparagraph (B) offered by the issuer in the area involved;
and
(ii) the actuarial value of the benefits
under the coverage is at least 100 percent
but not greater than 120 percent of a
weighted average (described in subparagraph (D)).
(D) Weighted average
For purposes of this paragraph, the
weighted average described in this subparagraph is the average actuarial value of the
benefits provided by all the health insurance
coverage issued (as elected by the issuer) either by that issuer or by all issuers in the
State in the individual market during the
previous year (not including coverage issued
under this section), weighted by enrollment
for the different coverage.
(4) Election
The issuer elections under this subsection
shall apply uniformly to all eligible individuals in the State for that issuer. Such an election shall be effective for policies offered during a period of not shorter than 2 years.
(5) Assumptions
For purposes of paragraph (3), the actuarial
value of benefits provided under individual
health insurance coverage shall be calculated
based on a standardized population and a set
of standardized utilization and cost factors.
(d) Special rules for network plans
(1) In general
In the case of a health insurance issuer that
offers health insurance coverage in the individual market through a network plan, the issuer may—
(A) limit the individuals who may be enrolled under such coverage to those who live,
reside, or work within the service area for
such network plan; and
(B) within the service area of such plan,
deny such coverage to such individuals if the
issuer has demonstrated, if required, to the
applicable State authority that—
(i) it will not have the capacity to deliver services adequately to additional individual enrollees because of its obligations to existing group contract holders
and enrollees and individual enrollees, and
(ii) it is applying this paragraph uniformly to individuals without regard to
any health status-related factor of such individuals and without regard to whether
the individuals are eligible individuals.
(2) 180-day suspension upon denial of coverage
An issuer, upon denying health insurance
coverage in any service area in accordance
with paragraph (1)(B), may not offer coverage
in the individual market within such service
area for a period of 180 days after such coverage is denied.
(e) 2 Application of financial capacity limits
(1) In general
A health insurance issuer may deny health
insurance coverage in the individual market
2 So

in original. Two subsecs. (e) have been enacted.

§ 300gg–42

TITLE 42—THE PUBLIC HEALTH AND WELFARE

to an eligible individual if the issuer has demonstrated, if required, to the applicable State
authority that—
(A) it does not have the financial reserves
necessary to underwrite additional coverage;
and
(B) it is applying this paragraph uniformly
to all individuals in the individual market in
the State consistent with applicable State
law and without regard to any health statusrelated factor of such individuals and without regard to whether the individuals are eligible individuals.
(2) 180-day suspension upon denial of coverage
An issuer upon denying individual health insurance coverage in any service area in accordance with paragraph (1) may not offer
such coverage in the individual market within
such service area for a period of 180 days after
the date such coverage is denied or until the
issuer has demonstrated, if required under applicable State law, to the applicable State authority that the issuer has sufficient financial
reserves to underwrite additional coverage,
whichever is later. A State may provide for
the application of this paragraph on a servicearea-specific basis.
(e) 2 Market requirements
(1) In general
The provisions of subsection (a) of this section shall not be construed to require that a
health insurance issuer offering health insurance coverage only in connection with group
health plans or through one or more bona fide
associations, or both, offer such health insurance coverage in the individual market.
(2) Conversion policies
A health insurance issuer offering health insurance coverage in connection with group
health plans under this subchapter shall not
be deemed to be a health insurance issuer offering individual health insurance coverage
solely because such issuer offers a conversion
policy.
(f) Construction
Nothing in this section shall be construed—
(1) to restrict the amount of the premium
rates that an issuer may charge an individual
for health insurance coverage provided in the
individual market under applicable State law;
or
(2) to prevent a health insurance issuer offering health insurance coverage in the individual market from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return
for adherence to programs of health promotion
and disease prevention.
(July 1, 1944, ch. 373, title XXVII, § 2741, as added
Pub. L. 104–191, title I, § 111(a), Aug. 21, 1996, 110
Stat. 1978.)
REFERENCES IN TEXT
Section 2701 of this Act, referred to in subsecs.
(a)(1)(B) and (b)(1)(A), is a reference to section 2701 of
act July 1, 1944. Section 2701, which was classified to
section 300gg of this title, was renumbered section 2704,
effective for plan years beginning on or after Jan. 1,

Page 1328

2014, with certain exceptions, and amended, by Pub. L.
111–148, title I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1),
title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911,
and was transferred to section 300gg–3 of this title. A
new section 2701 of act July 1, 1944, related to fair
health insurance premiums, was added, effective for
plan years beginning on or after Jan. 1, 2014, and
amended, by Pub. L. 111–148, title I, § 1201(4), title X,
§ 10103(a), Mar. 23, 2010, 124 Stat. 155, 892, and is classified to section 300gg of this title.
The Social Security Act, referred to in subsec. (b)(2),
is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.
Parts A and B of title XVIII of the Act are classified
generally to parts A (§ 1395c et seq.) and B (§ 1395j et
seq.) of subchapter XVIII of chapter 7 of this title. Title
XIX of the Act is classified generally to subchapter XIX
(§ 1396 et seq.) of chapter 7 of this title. For complete
classification of this Act to the Code, see section 1305
of this title and Tables.
Section 2712, referred to in subsec. (b)(3), is a reference to section 2712 of act July 1, 1944. Section 2712,
which was classified to section 300gg–12 of this title,
was renumbered section 2732 and amended and transferred to subsecs. (b) to (e) of section 300gg–2 of this
title by Pub. L. 111–148, title I, §§ 1001(3), 1563(c)(9), formerly § 1562(c)(9), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 130, 267, 911. A new section 2712 of act July 1, 1944,
related to prohibition on rescissions, was added by Pub.
L. 111–148, title I, § 1001(5), Mar. 23, 2010, 124 Stat. 131, effective for plan years beginning on or after the date
that is 6 months after Mar. 23, 2010, and is classified to
section 300gg–12 of this title.
EFFECTIVE DATE
Pub. L. 104–191, title I, § 111(b), Aug. 21, 1996, 110 Stat.
1987, provided that:
‘‘(1) IN GENERAL.—Except as provided in this subsection, part B of title XXVII of the Public Health
Service Act [42 U.S.C. 300gg–41 et seq.] (as inserted by
subsection (a)) shall apply with respect to health insurance coverage offered, sold, issued, renewed, in effect,
or operated in the individual market after June 30, 1997,
regardless of when a period of creditable coverage occurs.
‘‘(2) APPLICATION OF CERTIFICATION RULES.—The provisions of section 102(d)(2) [102(c)(2)] of this Act [set out
as a note under section 300gg of this title] shall apply
to section 2743 of the Public Health Service Act [42
U.S.C. 300gg–43] in the same manner as it applies to section 2701(e) [now 2704(e)] of such Act [42 U.S.C.
300gg–3(e)].’’

§ 300gg–42. Guaranteed renewability of individual health insurance coverage
(a) In general
Except as provided in this section, a health insurance issuer that provides individual health
insurance coverage to an individual shall renew
or continue in force such coverage at the option
of the individual.
(b) General exceptions
A health insurance issuer may nonrenew or
discontinue health insurance coverage of an individual in the individual market based only on
one or more of the following:
(1) Nonpayment of premiums
The individual has failed to pay premiums or
contributions in accordance with the terms of
the health insurance coverage or the issuer
has not received timely premium payments.
(2) Fraud
The individual has performed an act or practice that constitutes fraud or made an intentional misrepresentation of material fact
under the terms of the coverage.

Page 1329

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Termination of plan
The issuer is ceasing to offer coverage in the
individual market in accordance with subsection (c) of this section and applicable State
law.
(4) Movement outside service area
In the case of a health insurance issuer that
offers health insurance coverage in the market
through a network plan, the individual no
longer resides, lives, or works in the service
area (or in an area for which the issuer is authorized to do business) but only if such coverage is terminated under this paragraph uniformly without regard to any health status-related factor of covered individuals.
(5) Association membership ceases
In the case of health insurance coverage
that is made available in the individual market only through one or more bona fide associations, the membership of the individual in
the association (on the basis of which the coverage is provided) ceases but only if such coverage is terminated under this paragraph uniformly without regard to any health status-related factor of covered individuals.
(c) Requirements for uniform termination of coverage
(1) Particular type of coverage not offered
In any case in which an issuer decides to discontinue offering a particular type of health
insurance coverage offered in the individual
market, coverage of such type may be discontinued by the issuer only if—
(A) the issuer provides notice to each covered individual provided coverage of this
type in such market of such discontinuation
at least 90 days prior to the date of the discontinuation of such coverage;
(B) the issuer offers to each individual in
the individual market provided coverage of
this type, the option to purchase any other
individual health insurance coverage currently being offered by the issuer for individuals in such market; and
(C) in exercising the option to discontinue
coverage of this type and in offering the option of coverage under subparagraph (B), the
issuer acts uniformly without regard to any
health status-related factor of enrolled individuals or individuals who may become eligible for such coverage.
(2) Discontinuance of all coverage
(A) In general
Subject to subparagraph (C), in any case in
which a health insurance issuer elects to discontinue offering all health insurance coverage in the individual market in a State,
health insurance coverage may be discontinued by the issuer only if—
(i) the issuer provides notice to the applicable State authority and to each individual of such discontinuation at least 180
days prior to the date of the expiration of
such coverage, and
(ii) all health insurance issued or delivered for issuance in the State in such market are discontinued and coverage under

§ 300gg–43

such health insurance coverage in such
market is not renewed.
(B) Prohibition on market reentry
In the case of a discontinuation under subparagraph (A) in the individual market, the
issuer may not provide for the issuance of
any health insurance coverage in the market
and State involved during the 5-year period
beginning on the date of the discontinuation
of the last health insurance coverage not so
renewed.
(d) Exception for uniform modification of coverage
At the time of coverage renewal, a health insurance issuer may modify the health insurance
coverage for a policy form offered to individuals
in the individual market so long as such modification is consistent with State law and effective on a uniform basis among all individuals
with that policy form.
(e) Application to coverage offered only through
associations
In applying this section in the case of health
insurance coverage that is made available by a
health insurance issuer in the individual market
to individuals only through one or more associations, a reference to an ‘‘individual’’ is deemed
to include a reference to such an association (of
which the individual is a member).
(July 1, 1944, ch. 373, title XXVII, § 2742, as added
Pub. L. 104–191, title I, § 111(a), Aug. 21, 1996, 110
Stat. 1982.)
EFFECTIVE DATE
Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
see section 111(b) of Pub. L. 104–191, set out as a note
under section 300gg–41 of this title.

§ 300gg–43. Certification of coverage
The provisions of section 2701(e) 1 shall apply
to health insurance coverage offered by a health
insurance issuer in the individual market in the
same manner as it applies to health insurance
coverage offered by a health insurance issuer in
connection with a group health plan in the
small or large group market.
(July 1, 1944, ch. 373, title XXVII, § 2743, as added
Pub. L. 104–191, title I, § 111(a), Aug. 21, 1996, 110
Stat. 1983.)
REFERENCES IN TEXT
Section 2701 of this Act, referred to in text, is a reference to section 2701 of act July 1, 1944. Section 2701,
which was classified to section 300gg of this title, was
renumbered section 2704, effective for plan years beginning on or after Jan. 1, 2014, with certain exceptions,
and amended, by Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1), formerly § 1562(c)(1), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 154, 264, 911, and was transferred to
section 300gg–3 of this title. A new section 2701 of act
July 1, 1944, related to fair health insurance premiums,
was added, effective for plan years beginning on or
after Jan. 1, 2014, and amended, by Pub. L. 111–148, title
I, § 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
1 See

References in Text note below.

§ 300gg–44

TITLE 42—THE PUBLIC HEALTH AND WELFARE
EFFECTIVE DATE

Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
and provisions of section 102(c)(2) of Pub. L. 104–191, set
out as a note under section 300gg of this title, applicable to this section in the same manner as it applies to
section 300gg(e) of this title, see section 111(b) of Pub.
L. 104–191, set out as a note under section 300gg–41 of
this title.

§ 300gg–44. State flexibility in individual market
reforms
(a) Waiver of requirements where implementation of acceptable alternative mechanism
(1) In general
The requirements of section 300gg–41 of this
title shall not apply with respect to health insurance coverage offered in the individual
market in the State so long as a State is found
to be implementing, in accordance with this
section and consistent with section 300gg–62(b)
of this title, an alternative mechanism (in this
section referred to as an ‘‘acceptable alternative mechanism’’)—
(A) under which all eligible individuals are
provided a choice of health insurance coverage;
(B) under which such coverage does not
impose any preexisting condition exclusion
with respect to such coverage;
(C) under which such choice of coverage includes at least one policy form of coverage
that is comparable to comprehensive health
insurance coverage offered in the individual
market in such State or that is comparable
to a standard option of coverage available
under the group or individual health insurance laws of such State; and
(D) in a State which is implementing—
(i) a model act described in subsection
(c)(1) of this section,
(ii) a qualified high risk pool described in
subsection (c)(2) of this section, or
(iii) a mechanism described in subsection
(c)(3) of this section.
(2) Permissible forms of mechanisms
A private or public individual health insurance mechanism (such as a health insurance
coverage pool or programs, mandatory group
conversion policies, guaranteed issue of one or
more plans of individual health insurance coverage, or open enrollment by one or more
health insurance issuers), or combination of
such mechanisms, that is designed to provide
access to health benefits for individuals in the
individual market in the State in accordance
with this section may constitute an acceptable alternative mechanism.
(b) Application of acceptable alternative mechanisms
(1) Presumption
(A) In general
Subject to the succeeding provisions of
this subsection, a State is presumed to be
implementing an acceptable alternative
mechanism in accordance with this section
as of July 1, 1997, if, by not later than April

Page 1330

1, 1997, the chief executive officer of a
State—
(i) notifies the Secretary that the State
has enacted or intends to enact (by not
later than January 1, 1998, or July 1, 1998,
in the case of a State described in subparagraph (B)(ii)) any necessary legislation to
provide for the implementation of a mechanism reasonably designed to be an acceptable alternative mechanism as of January
1, 1998,1 (or, in the case of a State described
in subparagraph (B)(ii), July 1, 1998); and
(ii) provides the Secretary with such information as the Secretary may require to
review the mechanism and its implementation (or proposed implementation) under
this subsection.
(B) Delay permitted for certain States
(i) Effect of delay
In the case of a State described in clause
(ii) that provides notice under subparagraph (A)(i), for the presumption to continue on and after July 1, 1998, the chief
executive officer of the State by April 1,
1998—
(I) must notify the Secretary that the
State has enacted any necessary legislation to provide for the implementation
of a mechanism reasonably designed to
be an acceptable alternative mechanism
as of July 1, 1998; and
(II) must provide the Secretary with
such information as the Secretary may
require to review the mechanism and its
implementation (or proposed implementation) under this subsection.
(ii) States described
A State described in this clause is a
State that has a legislature that does not
meet within the 12-month period beginning
on August 21, 1996.
(C) Continued application
In order for a mechanism to continue to be
presumed to be an acceptable alternative
mechanism, the State shall provide the Secretary every 3 years with information described in subparagraph (A)(ii) or (B)(i)(II)
(as the case may be).
(2) Notice
If the Secretary finds, after review of information provided under paragraph (1) and in
consultation with the chief executive officer of
the State and the insurance commissioner or
chief insurance regulatory official of the
State, that such a mechanism is not an acceptable alternative mechanism or is not (or
no longer) being implemented, the Secretary—
(A) shall notify the State of—
(i) such preliminary determination, and
(ii) the consequences under paragraph (3)
of a failure to implement such a mechanism; and
(B) shall permit the State a reasonable opportunity in which to modify the mechanism
(or to adopt another mechanism) in a man1 So

in original. The comma probably should not appear.

Page 1331

TITLE 42—THE PUBLIC HEALTH AND WELFARE

ner so that may be an acceptable alternative
mechanism or to provide for implementation
of such a mechanism.
(3) Final determination
If, after providing notice and opportunity
under paragraph (2), the Secretary finds that
the mechanism is not an acceptable alternative mechanism or the State is not implementing such a mechanism, the Secretary
shall notify the State that the State is no
longer considered to be implementing an acceptable alternative mechanism and that the
requirements of section 300gg–41 of this title
shall apply to health insurance coverage offered in the individual market in the State, effective as of a date specified in the notice.
(4) Limitation on secretarial authority
The Secretary shall not make a determination under paragraph (2) or (3) on any basis
other than the basis that a mechanism is not
an acceptable alternative mechanism or is not
being implemented.
(5) Future adoption of mechanisms
If a State, after January 1, 1997, submits the
notice and information described in paragraph
(1), unless the Secretary makes a finding described in paragraph (3) within the 90-day period beginning on the date of submission of
the notice and information, the mechanism
shall be considered to be an acceptable alternative mechanism for purposes of this section,
effective 90 days after the end of such period,
subject to the second sentence of paragraph
(1).
(c) Provision related to risk
(1) Adoption of NAIC models
The model act referred to in subsection
(a)(1)(D)(i) of this section is the Small Employer and Individual Health Insurance Availability Model Act (adopted by the National
Association of Insurance Commissioners on
June 3, 1996) insofar as it applies to individual
health insurance coverage or the Individual
Health Insurance Portability Model Act (also
adopted by such Association on such date).
(2) Qualified high risk pool
For purposes of subsection (a)(1)(D)(ii) of
this section, a ‘‘qualified high risk pool’’ described in this paragraph is a high risk pool
that—
(A) provides to all eligible individuals
health insurance coverage (or comparable
coverage) that does not impose any preexisting condition exclusion with respect to such
coverage for all eligible individuals, and
(B) provides for premium rates and covered
benefits for such coverage consistent with
standards included in the NAIC Model
Health Plan for Uninsurable Individuals Act
(as in effect as of August 21, 1996).
(3) Other mechanisms
For purposes of subsection (a)(1)(D)(iii) of
this section, a mechanism described in this
paragraph—
(A) provides for risk adjustment, risk
spreading, or a risk spreading mechanism
(among issuers or policies of an issuer) or

§ 300gg–45

otherwise provides for some financial subsidization for eligible individuals, including
through assistance to participating issuers;
or
(B) is a mechanism under which each eligible individual is provided a choice of all individual health insurance coverage otherwise available.
(July 1, 1944, ch. 373, title XXVII, § 2744, as added
Pub. L. 104–191, title I, § 111(a), Aug. 21, 1996, 110
Stat. 1984; amended Pub. L. 104–204, title VI,
§ 605(b)(1), Sept. 26, 1996, 110 Stat. 2942.)
CODIFICATION
August 21, 1996, referred to in subsec. (b)(1)(B)(ii), was
in the original ‘‘the date of enactment of this Act’’,
which was translated as meaning the date of enactment
of Pub. L. 104–191, which enacted this subchapter, to reflect the probable intent of Congress.
AMENDMENTS
1996—Subsec. (a)(1). Pub. L. 104–204 made technical
amendment to reference in original act which appears
in text as reference to section 300gg–62(b) of this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Section 605(c) of Pub. L. 104–204 provided that: ‘‘The
amendments made by this section [enacting section
300gg–51 of this title and amending this section and sections 300gg–61 and 300gg–62 of this title] shall apply
with respect to health insurance coverage offered, sold,
issued, renewed, in effect, or operated in the individual
market on or after January 1, 1998.’’
EFFECTIVE DATE
Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
see section 111(b) of Pub. L. 104–191, set out as a note
under section 300gg–41 of this title.

§ 300gg–45. Relief for high risk pools
(a) Seed grants to States
The Secretary shall provide from the funds appropriated under subsection (d)(1)(A) a grant of
up to $1,000,000 to each State that has not created a qualified high risk pool as of February 10,
2006, for the State’s costs of creation and initial
operation of such a pool.
(b) Grants for operational losses
(1) In general
In the case of a State that has established a
qualified high risk pool that—
(A) restricts premiums charged under the
pool to no more than 200 percent of the premium for applicable standard risk rates;
(B) offers a choice of two or more coverage
options through the pool; and
(C) has in effect a mechanism reasonably
designed to ensure continued funding of
losses incurred by the State in connection
with operation of the pool after the end of
the last fiscal year for which a grant is provided under this paragraph;
the Secretary shall provide, from the funds appropriated under paragraphs (1)(B)(i) and
(2)(A) of subsection (d) and allotted to the
State under paragraph (2), a grant for the
losses incurred by the State in connection
with the operation of the pool.

§ 300gg–45

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Allotment
Subject to paragraph (4), the amounts appropriated under paragraphs (1)(B)(i) and (2)(A) of
subsection (d) for a fiscal year shall be allotted and made available to the States (or the
entities that operate the high risk pool under
applicable State law) that qualify for a grant
under paragraph (1) as follows:
(A) An amount equal to 40 percent of such
appropriated amount for the fiscal year shall
be allotted in equal amounts to each qualifying State that is one of the 50 States or the
District of Columbia and that applies for a
grant under this subsection.
(B) An amount equal to 30 percent of such
appropriated amount for the fiscal year shall
be allotted among qualifying States that
apply for such a grant so that the amount
allotted to such a State bears the same ratio
to such appropriated amount as the number
of uninsured individuals in the State bears
to the total number of uninsured individuals
(as determined by the Secretary) in all
qualifying States that so apply.
(C) An amount equal to 30 percent of such
appropriated amount for the fiscal year shall
be allotted among qualifying States that
apply for such a grant so that the amount
allotted to a State bears the same ratio to
such appropriated amount as the number of
individuals enrolled in health care coverage
through the qualified high risk pool of the
State bears to the total number of individuals so enrolled through qualified high risk
pools (as determined by the Secretary) in all
qualifying States that so apply.
(3) Special rule for pools charging higher premiums
In the case of a qualified high risk pool of a
State which charges premiums that exceed 150
percent of the premium for applicable standard risks, the State shall use at least 50 percent of the amount of the grant provided to
the State to carry out this subsection to reduce premiums for enrollees.
(4) Limitation for territories
In no case shall the aggregate amount allotted and made available under paragraph (2) for
a fiscal year to States that are not the 50
States or the District of Columbia exceed
$1,000,000.
(c) Bonus grants for supplemental consumer benefits
(1) In general
In the case of a State that is one of the 50
States or the District of Columbia, that has
established a qualified high risk pool, and that
is receiving a grant under subsection (b)(1),
the Secretary shall provide, from the funds appropriated under paragraphs (1)(B)(ii) and
(2)(B) of subsection (d) and allotted to the
State under paragraph (3), a grant to be used
to provide supplemental consumer benefits to
enrollees or potential enrollees (or defined
subsets of such enrollees or potential enrollees) in qualified high risk pools.
(2) Benefits
A State shall use amounts received under a
grant under this subsection to provide one or
more of the following benefits:

Page 1332

(A) Low-income premium subsidies.
(B) A reduction in premium trends, actual
premiums, or other cost-sharing requirements.
(C) An expansion or broadening of the pool
of individuals eligible for coverage, such as
through eliminating waiting lists, increasing enrollment caps, or providing flexibility
in enrollment rules.
(D) Less stringent rules, or additional
waiver authority, with respect to coverage
of pre-existing conditions.
(E) Increased benefits.
(F) The establishment of disease management programs.
(3) Allotment; limitation
The Secretary shall allot funds appropriated
under paragraphs (1)(B)(ii) and (2)(B) of subsection (d) among States qualifying for a
grant under paragraph (1) in a manner specified by the Secretary, but in no case shall the
amount so allotted to a State for a fiscal year
exceed 10 percent of the funds so appropriated
for the fiscal year.
(4) Rule of construction
Nothing in this subsection shall be construed to prohibit a State that, on February
10, 2006, is in the process of implementing a
program to provide benefits of the type described in paragraph (2), from being eligible
for a grant under this subsection.
(d) Funding
(1) Appropriation for fiscal year 2006
There are authorized to be appropriated for
fiscal year 2006—
(A) $15,000,000 to carry out subsection (a);
and
(B) $75,000,000, of which, subject to paragraph (4)—
(i) two-thirds of the amount appropriated shall be made available for allotments under subsection (b)(2); and
(ii) one-third of the amount appropriated
shall be made available for allotments
under subsection (c)(3).
(2) Authorization of appropriations for fiscal
years 2007 through 2010
There are authorized to be appropriated
$75,000,000 for each of fiscal years 2007 through
2010, of which, subject to paragraph (4)—
(A) two-thirds of the amount appropriated
for a fiscal year shall be made available for
allotments under subsection (b)(2); and
(B) one-third of the amount appropriated
for a fiscal year shall be made available for
allotments under subsection (c)(3).
(3) Availability
Funds appropriated for purposes of carrying
out this section for a fiscal year shall remain
available for obligation through the end of the
following fiscal year.
(4) Reallotment
If, on June 30 of each fiscal year for which
funds are appropriated under paragraph (1)(B)
or (2), the Secretary determines that all the
amounts so appropriated are not allotted or
otherwise made available to States, such re-

Page 1333

TITLE 42—THE PUBLIC HEALTH AND WELFARE

maining amounts shall be allotted and made
available under subsection (b) among States
receiving grants under subsection (b) for the
fiscal year based upon the allotment formula
specified in such subsection.
(5) No entitlement
Nothing in this section shall be construed as
providing a State with an entitlement to a
grant under this section.
(e) Applications
To be eligible for a grant under this section, a
State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
(f) Annual report
The Secretary shall submit to Congress an annual report on grants provided under this section. Each such report shall include information
on the distribution of such grants among States
and the use of grant funds by States.
(g) Definitions
In this section:
(1) Qualified high risk pool
(A) 1 In general
The term ‘‘qualified high risk pool’’ has
the meaning given such term in section
300gg–44(c)(2) of this title, except that a
State may elect to meet the requirement of
subparagraph (A) of such section (insofar as
it requires the provision of coverage to all
eligible individuals) through providing for
the enrollment of eligible individuals
through an acceptable alternative mechanism (as defined for purposes of section
300gg–44 of this title) that includes a high
risk pool as a component.
(2) Standard risk rate
The term ‘‘standard risk rate’’ means a
rate—
(A) determined under the State high risk
pool by considering the premium rates
charged by other health insurers offering
health insurance coverage to individuals in
the insurance market served;
(B) that is established using reasonable actuarial techniques; and
(C) that reflects anticipated claims experience and expenses for the coverage involved.
(3) State
The term ‘‘State’’ means any of the 50
States and the District of Columbia and includes Puerto Rico, the Virgin Islands, Guam,
American Samoa, and the Northern Mariana
Islands.
(July 1, 1944, ch. 373, title XXVII, § 2745, as added
Pub. L. 107–210, div. A, title II, § 201(b), Aug. 6,
2002, 116 Stat. 959; amended Pub. L. 109–172, § 2,
Feb. 10, 2006, 120 Stat. 185.)
AMENDMENTS
2006—Pub. L. 109–172 amended section generally, substituting provisions relating to relief for high risk
pools for provisions relating to promotion of qualified
high risk pools.
1 So

in original. No subpar. (B) has been enacted.

§ 300gg–51

CONSTRUCTION
Nothing in the amendments made by title II of Pub.
L. 107–210, other than provisions relating to COBRA
continuation coverage and reporting requirements, to
be construed as creating a new mandate on any party
regarding health insurance coverage, see section 203(f)
of Pub. L. 107–210, set out as a Construction of 2002
Amendment note under section 2918 of Title 29, Labor.
SUBPART 2—OTHER REQUIREMENTS

AMENDMENTS
2008—Pub. L. 110–233, title I, § 102(b)(1)(A), May 21,
2008, 122 Stat. 892, redesignated this subpart, which was
originally enacted as subpart 3 of part B of title XXVII
of act July 1, 1944, as subpart 2.

§ 300gg–51. Standards relating to benefits for
mothers and newborns
(a) In general
The provisions of section 2704 1 (other than
subsections (d) and (f)) shall apply to health insurance coverage offered by a health insurance
issuer in the individual market in the same
manner as it applies to health insurance coverage offered by a health insurance issuer in
connection with a group health plan in the
small or large group market.
(b) Notice requirement
A health insurance issuer under this part shall
comply with the notice requirement under section 1185(d) of title 29 with respect to the requirements referred to in subsection (a) of this
section as if such section applied to such issuer
and such issuer were a group health plan.
(c) Preemption; exception for health insurance
coverage in certain States
(1) In general
The requirements of this section shall not
apply with respect to health insurance coverage if there is a State law (as defined in section 300gg–23(d)(1) 1 of this title) for a State
that regulates such coverage that is described
in any of the following subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital
length of stay following a normal vaginal delivery and at least a 96-hour hospital length
of stay following a cesarean section.
(B) Such State law requires such coverage
to provide for maternity and pediatric care
in accordance with guidelines established by
the American College of Obstetricians and
Gynecologists, the American Academy of
Pediatrics, or other established professional
medical associations.
(C) Such State law requires, in connection
with such coverage for maternity care, that
the hospital length of stay for such care is
left to the decision of (or required to be
made by) the attending provider in consultation with the mother.
(2) Construction
Section 300gg–62(a) of this title shall not be
construed as superseding a State law described
in paragraph (1).
(July 1, 1944, ch. 373, title XXVII, § 2751, as added
Pub. L. 104–204, title VI, § 605(a)(4), Sept. 26, 1996,
110 Stat. 2941.)
1 See

References in Text note below.

§ 300gg–52

TITLE 42—THE PUBLIC HEALTH AND WELFARE
REFERENCES IN TEXT

Section 2704, referred to in subsec. (a), is a reference
to section 2704 of act July 1, 1944. Section 2704, which
was classified to section 300gg–4 of this title, was renumbered section 2725, and amended by Pub. L. 111–148,
title I, §§ 1001(2), 1563(c)(3), formerly § 1562(c)(3), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 911, and was
transferred to section 300gg–25 of this title. A new section 2704 of act July 1, 1944, related to prohibition of
preexisting condition exclusions or other discrimination based on health status, was added, effective for
plan years beginning on or after Jan. 1, 2014, with certain exceptions, and amended, by Pub. L. 111–148, title
I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911, and is
classified to section 300gg–3 of this title.
Section 300gg–23(d)(1) of this title, referred to in subsec. (c)(1), was in the original ‘‘section 2723(d)(1)’’, and
was translated as meaning section 2724(d)(1) of act July
1, 1944, to reflect the probable intent of Congress and
the renumbering of section 2723 as 2724 by Pub. L.
111–148, title I, §§ 1001(4), 1563(c)(14)(B), formerly
§ 1562(c)(14)(B), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 130, 269, 911.
EFFECTIVE DATE
Section applicable to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the
individual market on or after Jan. 1, 1998, see section
605(c) of Pub. L. 104–204, set out as an Effective Date of
1996 Amendment note under section 300gg–44 of this
title.

§ 300gg–52. Required coverage for reconstructive
surgery following mastectomies
The provisions of section 2706 1 shall apply to
health insurance coverage offered by a health
insurance issuer in the individual market in the
same manner as they apply to health insurance
coverage offered by a health insurance issuer in
connection with a group health plan in the
small or large group market.
(July 1, 1944, ch. 373, title XXVII, § 2752, as added
Pub. L. 105–277, div. A, § 101(f) [title IX, § 903(b)],
Oct. 21, 1998, 112 Stat. 2681–337, 2681–438.)
REFERENCES IN TEXT
Section 2706, referred to in text, is a reference to section 2706 of act July 1, 1944. Section 2706, which was
classified to section 300gg–6 of this title, was renumbered section 2727 and amended by Pub. L. 111–148, title
I, §§ 1001(2), 1563(c)(5), formerly § 1562(c)(5), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 266, 911, and was
transferred to section 300gg–27 of this title. A new section 2706 of act July 1, 1944, related to non-discrimination in health care, was added, effective for plan years
beginning on or after Jan. 1, 2014, by Pub. L. 111–148,
title I, § 1201(4), Mar. 23, 2010, 124 Stat. 160, and is classified to section 300gg–5 of this title.
EFFECTIVE DATE
Pub. L. 105–277, div. A, § 101(f) [title IX, § 903(c)(2)],
Oct. 21, 1998, 112 Stat. 2681–337, 2681–438, provided that:
‘‘The amendment made by subsection (b) [enacting this
section] shall apply with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after the date of
enactment of this Act [Oct. 21, 1998].’’
1 See

References in Text note below.

Page 1334

§ 300gg–53. Prohibition of health discrimination
on the basis of genetic information
(a) Prohibition on genetic information as a condition of eligibility
(1) In general
A health insurance issuer offering health insurance coverage in the individual market
may not establish rules for the eligibility (including continued eligibility) of any individual to enroll in individual health insurance
coverage based on genetic information.
(2) Rule of construction
Nothing in paragraph (1) or in paragraphs (1)
and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from establishing rules for eligibility for an individual to
enroll in individual health insurance coverage
based on the manifestation of a disease or disorder in that individual, or in a family member of such individual where such family member is covered under the policy that covers
such individual.
(b) Prohibition on genetic information in setting
premium rates
(1) In general
A health insurance issuer offering health insurance coverage in the individual market
shall not adjust premium or contribution
amounts for an individual on the basis of genetic information concerning the individual or
a family member of the individual.
(2) Rule of construction
Nothing in paragraph (1) or in paragraphs (1)
and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from adjusting premium or contribution amounts for
an individual on the basis of a manifestation
of a disease or disorder in that individual, or
in a family member of such individual where
such family member is covered under the policy that covers such individual. In such case,
the manifestation of a disease or disorder in
one individual cannot also be used as genetic
information about other individuals covered
under the policy issued to such individual and
to further increase premiums or contribution
amounts.
(c) Prohibition on genetic information as preexisting condition
(1) In general
A health insurance issuer offering health insurance coverage in the individual market
may not, on the basis of genetic information,
impose any preexisting condition exclusion (as
defined in section 2701(b)(1)(A)) 1 with respect
to such coverage.
(2) Rule of construction
Nothing in paragraph (1) or in paragraphs (1)
and (2) of subsection (e) shall be construed to
preclude a health insurance issuer from imposing any preexisting condition exclusion for an
individual with respect to health insurance
coverage on the basis of a manifestation of a
disease or disorder in that individual.
1 See

References in Text note below.

Page 1335

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(d) Genetic testing
(1) Limitation on requesting or requiring genetic testing
A health insurance issuer offering health insurance coverage in the individual market
shall not request or require an individual or a
family member of such individual to undergo a
genetic test.
(2) Rule of construction
Paragraph (1) shall not be construed to limit
the authority of a health care professional
who is providing health care services to an individual to request that such individual undergo a genetic test.
(3) Rule of construction regarding payment
(A) In general
Nothing in paragraph (1) shall be construed to preclude a health insurance issuer
offering health insurance coverage in the individual market from obtaining and using
the results of a genetic test in making a determination regarding payment (as such
term is defined for the purposes of applying
the regulations promulgated by the Secretary under part C of title XI of the Social
Security Act [42 U.S.C. 1320d et seq.] and section 264 of the Health Insurance Portability
and Accountability Act of 1996, as may be revised from time to time) consistent with
subsection 2 (a) and (c).
(B) Limitation
For purposes of subparagraph (A), a health
insurance issuer offering health insurance
coverage in the individual market may request only the minimum amount of information necessary to accomplish the intended
purpose.
(4) Research exception
Notwithstanding paragraph (1), a health insurance issuer offering health insurance coverage in the individual market may request,
but not require, that an individual or a family
member of such individual undergo a genetic
test if each of the following conditions is met:
(A) The request is made pursuant to research that complies with part 46 of title 45,
Code of Federal Regulations, or equivalent
Federal regulations, and any applicable
State or local law or regulations for the protection of human subjects in research.
(B) The issuer clearly indicates to each individual, or in the case of a minor child, to
the legal guardian of such child, to whom
the request is made that—
(i) compliance with the request is voluntary; and
(ii) non-compliance will have no effect
on enrollment status or premium or contribution amounts.
(C) No genetic information collected or acquired under this paragraph shall be used for
underwriting purposes.
(D) The issuer notifies the Secretary in
writing that the issuer is conducting activities pursuant to the exception provided for
2 So

in original. Probably should be ‘‘subsections’’.

§ 300gg–53

under this paragraph, including a description of the activities conducted.
(E) The issuer complies with such other
conditions as the Secretary may by regulation require for activities conducted under
this paragraph.
(e) Prohibition on collection of genetic information
(1) In general
A health insurance issuer offering health insurance coverage in the individual market
shall not request, require, or purchase genetic
information for underwriting purposes (as defined in section 300gg–91 of this title).
(2) Prohibition on collection of genetic information prior to enrollment
A health insurance issuer offering health insurance coverage in the individual market
shall not request, require, or purchase genetic
information with respect to any individual
prior to such individual’s enrollment under
the plan in connection with such enrollment.
(3) Incidental collection
If a health insurance issuer offering health
insurance coverage in the individual market
obtains genetic information incidental to the
requesting, requiring, or purchasing of other
information concerning any individual, such
request, requirement, or purchase shall not be
considered a violation of paragraph (2) if such
request, requirement, or purchase is not in
violation of paragraph (1).
(f) Genetic information of a fetus or embryo
Any reference in this part to genetic information concerning an individual or family member
of an individual shall—
(1) with respect to such an individual or family member of an individual who is a pregnant
woman, include genetic information of any
fetus carried by such pregnant woman; and
(2) with respect to an individual or family
member utilizing an assisted reproductive
technology, include genetic information of
any embryo legally held by the individual or
family member.
(July 1, 1944, ch. 373, title XXVII, § 2753, as added
Pub. L. 110–233, title I, § 102(b)(1)(B), May 21, 2008,
122 Stat. 893.)
REFERENCES IN TEXT
Section 2701, referred to in subsec. (c)(1), is a reference to section 2701 of act July 1, 1944. Section 2701,
which was classified to section 300gg of this title, was
renumbered section 2704, effective for plan years beginning on or after Jan. 1, 2014, with certain exceptions,
and amended, by Pub. L. 111–148, title I, §§ 1201(2),
1563(c)(1), formerly § 1562(c)(1), title X, § 10107(b)(1), Mar.
23, 2010, 124 Stat. 154, 264, 911, and was transferred to
section 300gg–3 of this title. A new section 2701 of act
July 1, 1944, related to fair health insurance premiums,
was added, effective for plan years beginning on or
after Jan. 1, 2014, and amended, by Pub. L. 111–148, title
I, § 1201(4), title X, § 10103(a), Mar. 23, 2010, 124 Stat. 155,
892, and is classified to section 300gg of this title.
The Social Security Act, referred to in subsec.
(d)(3)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Part
C of title XI of the Act is classified generally to part
C (§ 1320d et seq.) of subchapter XI of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.

§ 300gg–54

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Section 264 of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec.
(d)(3)(A), is section 264 of Pub. L. 104–191, which is set
out as a note under section 1320d–2 of this title.
CODIFICATION
Another section 2753 of act July 1, 1944, is classified
to section 300gg–54 of this title.
EFFECTIVE DATE
Section applicable, with respect to group health plans
and health insurance coverage offered in connection
with group health plans, for plan years beginning after
the date that is one year after May 21, 2008, and, with
respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual
market, after the date that is one year after May 21,
2008, see section 102(d)(2) of Pub. L. 110–233, set out as
an Effective Date of 2008 Amendment note under section 300gg–21 of this title.

§ 300gg–54. Coverage of dependent students on
medically necessary leave of absence
The provisions of section 2707 1 shall apply to
health insurance coverage offered by a health
insurance issuer in the individual market in the
same manner as they apply to health insurance
coverage offered by a health insurance issuer in
connection with a group health plan in the
small or large group market.
(July 1, 1944, ch. 373, title XXVII, § 2753, as added
Pub. L. 110–381, § 2(b)(2), Oct. 9, 2008, 122 Stat.
4084.)
REFERENCES IN TEXT
Section 2707, referred to in text, is a reference to section 2707 of act July 1, 1944. Section 2707, which was
classified to section 300gg–7 of this title, was renumbered section 2728 and amended by Pub. L. 111–148, title
I, §§ 1001(2), 1563(c)(6), formerly § 1562(c)(6), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 266, 911, and was
transferred to section 300gg–28 of this title. A new section 2707 of act July 1, 1944, related to comprehensive
health insurance coverage, was added, effective for plan
years beginning on or after Jan. 1, 2014, by Pub. L.
111–148, title I, § 1201(4), Mar. 23, 2010, 124 Stat. 161, and
is classified to section 300gg–6 of this title.

Page 1336

title I, § 102(b)(1)(A), May 21, 2008, 122 Stat. 892, and is
classified to subpart 2 (§ 300gg–51 et seq.) of this part.

§ 300gg–61. Enforcement
(a) State enforcement
(1) State authority
Subject to section 300gg–62 of this title, each
State may require that health insurance issuers that issue, sell, renew, or offer health insurance coverage in the State in the individual market meet the requirements established
under this part with respect to such issuers.
(2) Failure to implement requirements
In the case of a State that fails to substantially enforce the requirements set forth in
this part with respect to health insurance issuers in the State, the Secretary shall enforce
the requirements of this part under subsection
(b) of this section insofar as they relate to the
issuance, sale, renewal, and offering of health
insurance coverage in the individual market
in such State.
(b) Secretarial enforcement authority
The Secretary shall have the same authority
in relation to enforcement of the provisions of
this part with respect to issuers of health insurance coverage in the individual market in a
State as the Secretary has under section
300gg–22(b)(2) of this title, and section
300gg–22(b)(3) of this title 1 with respect to violations of genetic nondiscrimination provisions, in
relation to the enforcement of the provisions of
part A with respect to issuers of health insurance coverage in the small group market in the
State.
(July 1, 1944, ch. 373, title XXVII, § 2761, formerly
§ 2745, as added Pub. L. 104–191, title I, § 111(a),
Aug. 21, 1996, 110 Stat. 1986; renumbered § 2761
and amended Pub. L. 104–204, title VI, § 605(a)(2),
(b)(2), Sept. 26, 1996, 110 Stat. 2941, 2942; Pub. L.
110–233, title I, § 102(b)(2), May 21, 2008, 122 Stat.
895.)

CODIFICATION

REFERENCES IN TEXT

Section 2(b)(2) of Pub. L. 110–381, which directed
amendment of subpart 3 of part B of title XXVII of act
July 1, 1944, by adding this section at the end, was executed in this subpart, which is subpart 2 of part B of
title XXVII of act July 1, 1944, to reflect the probable
intent of Congress and the redesignation of subpart 3 as
subpart 2 by Pub. L. 110–233, title I, § 102(b)(1)(A), May
21, 2008, 122 Stat. 893.
Another section 2753 of act July 1, 1944, is classified
to section 300gg–53 of this title.

Section 300gg–22(b)(2) of this title, and section
300gg–22(b)(3) of this title, referred to in subsec. (b), was
in the original ‘‘section 2722(b)(2), and section
2722(b)(3)’’ and was translated as meaning section
2723(b)(2) and section 2723(b)(3) of act July 1, 1944, to reflect the probable intent of Congress and the renumbering of section 2722 as 2723 by Pub. L. 111–148, title I,
§§ 1001(4), 1563(c)(13)(C), formerly § 1562(c)(13)(C), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 269, 911.

EFFECTIVE DATE
Section applicable with respect to plan years beginning on or after the date that is one year after Oct. 9,
2008, and to medically necessary leaves of absence beginning during such plan years, see section 2(d) of Pub.
L. 110–381, set out as a note under section 9813 of Title
26, Internal Revenue Code.
SUBPART 3—GENERAL PROVISIONS

CODIFICATION
Another subpart 3 of part B of title XXVII of act July
1, 1944, was redesignated subpart 2 by Pub. L. 110–233,
1 See

References in Text note below.

AMENDMENTS
2008—Subsec. (b). Pub. L. 110–233 amended subsec. (b)
generally. Prior to amendment, text read as follows:
‘‘The Secretary shall have the same authority in relation to enforcement of the provisions of this part with
respect to issuers of health insurance coverage in the
individual market in a State as the Secretary has
under section 300gg–22(b)(2) of this title in relation to
the enforcement of the provisions of part A of this subchapter with respect to issuers of health insurance coverage in the small group market in the State.’’
1996—Subsec. (a)(1). Pub. L. 104–204 made technical
amendment to reference in original act which appears
in text as reference to section 300gg–62 of this title.
1 See

References in Text note below.

Page 1337

TITLE 42—THE PUBLIC HEALTH AND WELFARE

EFFECTIVE DATE OF 2008 AMENDMENT
Amendment by Pub. L. 110–233 applicable, with respect to group health plans and health insurance coverage offered in connection with group health plans, for
plan years beginning after the date that is one year
after May 21, 2008, and, with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market, after the date that is
one year after May 21, 2008, see section 102(d)(2) of Pub.
L. 110–233, set out as a note under section 300gg–21 of
this title.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–204 applicable to health
insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after
Jan. 1, 1998, see section 605(c) of Pub. L. 104–204, set out
as a note under section 300gg–44 of this title.
EFFECTIVE DATE
Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
see section 111(b) of Pub. L. 104–191, set out as a note
under section 300gg–41 of this title.

§ 300gg–62. Preemption and application
(a) In general
Subject to subsection (b) of this section, nothing in this part (or part C of this subchapter insofar as it applies to this part) shall be construed to prevent a State from establishing, implementing, or continuing in effect standards
and requirements unless such standards and requirements prevent the application of a requirement of this part.
(b) Rules of construction
(1) Nothing in this part (or part C of this subchapter insofar as it applies to this part) shall
be construed to affect or modify the provisions
of section 1144 of title 29.
(2) Nothing in this part (other than section
300gg–51 of this title) shall be construed as requiring health insurance coverage offered in the
individual market to provide specific benefits
under the terms of such coverage.
(c) Application of part A provisions
(1) In general
The provisions of part A shall apply to
health insurance issuers providing health insurance coverage in the individual market in a
State as provided for in such part.
(2) Clarification
To the extent that any provision of this part
conflicts with a provision of part A with respect to health insurance issuers providing
health insurance coverage in the individual
market in a State, the provisions of such part
A shall apply.
(July 1, 1944, ch. 373, title XXVII, § 2762, formerly
§ 2746, as added Pub. L. 104–191, title I, § 111(a),
Aug. 21, 1996, 110 Stat. 1987; renumbered § 2762
and amended, Pub. L. 104–204, title VI, § 605(a)(2),
(b)(3), Sept. 26, 1996, 110 Stat. 2941, 2942; Pub. L.
111–148, title I, § 1563(c)(15), formerly § 1562(c)(15),
title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 269,
911.)
AMENDMENTS
2010—Pub. L. 111–148, § 1563(c)(15)(A), formerly
§ 1562(c)(15)(A), as renumbered by Pub. L. 111–148,

§ 300gg–91

§ 10107(b)(1), inserted ‘‘and application’’ after ‘‘Preemption’’ in section catchline.
Subsec. (c). Pub. L. 111–148, § 1563(c)(15)(B), formerly
§ 1562(c)(15)(B), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), added subsec. (c).
1996—Subsec. (b). Pub. L. 104–204, § 605(b)(3), designated existing provisions as par. (1) and added par.
(2).
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104–204 applicable to health
insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after
Jan. 1, 1998, see section 605(c) of Pub. L. 104–204, set out
as a note under section 300gg–44 of this title.
EFFECTIVE DATE
Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
see section 111(b) of Pub. L. 104–191, set out as a note
under section 300gg–41 of this title.

§ 300gg–63. General exceptions
(a) Exception for certain benefits
The requirements of this part shall not apply
to any health insurance coverage in relation to
its provision of excepted benefits described in
section 300gg–91(c)(1) of this title.
(b) Exception for certain benefits if certain conditions met
The requirements of this part shall not apply
to any health insurance coverage in relation to
its provision of excepted benefits described in
paragraph (2), (3), or (4) of section 300gg–91(c) of
this title if the benefits are provided under a
separate policy, certificate, or contract of insurance.
(July 1, 1944, ch. 373, title XXVII, § 2763, formerly
§ 2747, as added Pub. L. 104–191, title I, § 111(a),
Aug. 21, 1996, 110 Stat. 1987; renumbered § 2763,
Pub. L. 104–204, title VI, § 605(a)(2), Sept. 26, 1996,
110 Stat. 2941.)
EFFECTIVE DATE
Section applicable with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs,
see section 111(b) of Pub. L. 104–191, set out as a note
under section 300gg–41 of this title.

PART C—DEFINITIONS; MISCELLANEOUS
PROVISIONS
§ 300gg–91. Definitions
(a) Group health plan
(1) Definition
The term ‘‘group health plan’’ means an employee welfare benefit plan (as defined in section 3(1) of the Employee Retirement Income
Security Act of 1974 [29 U.S.C. 1002(1)]) to the
extent that the plan provides medical care (as
defined in paragraph (2)) and including items
and services paid for as medical care) to employees or their dependents (as defined under
the terms of the plan) directly or through insurance, reimbursement, or otherwise.
(2) Medical care
The term ‘‘medical care’’ means amounts
paid for—

§ 300gg–91

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the diagnosis, cure, mitigation, treatment, or prevention of disease, or amounts
paid for the purpose of affecting any structure or function of the body,
(B) amounts paid for transportation primarily for and essential to medical care referred to in subparagraph (A), and
(C) amounts paid for insurance covering
medical care referred to in subparagraphs
(A) and (B).
(3) Treatment of certain plans as group health
plan for notice provision
A program under which creditable coverage
described in subparagraph (C), (D), (E), or (F)
of section 2701(c)(1) 1 is provided shall be treated as a group health plan for purposes of applying section 2701(e).1
(b) Definitions relating to health insurance
(1) Health insurance coverage
The term ‘‘health insurance coverage’’
means benefits consisting of medical care
(provided directly, through insurance or reimbursement, or otherwise and including items
and services paid for as medical care) under
any hospital or medical service policy or certificate, hospital or medical service plan contract, or health maintenance organization
contract offered by a health insurance issuer.
(2) Health insurance issuer
The term ‘‘health insurance issuer’’ means
an insurance company, insurance service, or
insurance organization (including a health
maintenance organization, as defined in paragraph (3)) which is licensed to engage in the
business of insurance in a State and which is
subject to State law which regulates insurance
(within the meaning of section 514(b)(2) of the
Employee Retirement Income Security Act of
1974 [29 U.S.C. 1144(b)(2)]). Such term does not
include a group health plan.
(3) Health maintenance organization
The term ‘‘health maintenance organization’’ means—
(A) a Federally qualified health maintenance organization (as defined in section
300e(a) of this title),
(B) an organization recognized under State
law as a health maintenance organization,
or
(C) a similar organization regulated under
State law for solvency in the same manner
and to the same extent as such a health
maintenance organization.
(4) Group health insurance coverage
The term ‘‘group health insurance coverage’’
means, in connection with a group health
plan, health insurance coverage offered in connection with such plan.
(5) Individual health insurance coverage
The term ‘‘individual health insurance coverage’’ means health insurance coverage offered to individuals in the individual market,
but does not include short-term limited duration insurance.
(c) Excepted benefits
For purposes of this subchapter, the term ‘‘excepted benefits’’ means benefits under one or
1 See

References in Text note below.

Page 1338

more (or any combination thereof) of the following:
(1) Benefits not subject to requirements
(A) Coverage only for accident, or disability
income insurance, or any combination thereof.
(B) Coverage issued as a supplement to liability insurance.
(C) Liability insurance, including general liability insurance and automobile liability insurance.
(D) Workers’ compensation or similar insurance.
(E) Automobile medical payment insurance.
(F) Credit-only insurance.
(G) Coverage for on-site medical clinics.
(H) Other similar insurance coverage, specified in regulations, under which benefits for
medical care are secondary or incidental to
other insurance benefits.
(2) Benefits not subject to requirements if offered separately
(A) Limited scope dental or vision benefits.
(B) Benefits for long-term care, nursing
home care, home health care, communitybased care, or any combination thereof.
(C) Such other similar, limited benefits as
are specified in regulations.
(3) Benefits not subject to requirements if offered as independent, noncoordinated benefits
(A) Coverage only for a specified disease or
illness.
(B) Hospital indemnity or other fixed indemnity insurance.
(4) Benefits not subject to requirements if offered as separate insurance policy
Medicare supplemental health insurance (as
defined under section 1395ss(g)(1) of this title),
coverage supplemental to the coverage provided under chapter 55 of title 10, and similar
supplemental coverage provided to coverage
under a group health plan.
(d) Other definitions
(1) Applicable State authority
The term ‘‘applicable State authority’’
means, with respect to a health insurance issuer in a State, the State insurance commissioner or official or officials designated by the
State to enforce the requirements of this subchapter for the State involved with respect to
such issuer.
(2) Beneficiary
The term ‘‘beneficiary’’ has the meaning
given such term under section 3(8) of the Employee Retirement Income Security Act of 1974
[29 U.S.C. 1002(8)].
(3) Bona fide association
The term ‘‘bona fide association’’ means,
with respect to health insurance coverage offered in a State, an association which—
(A) has been actively in existence for at
least 5 years;
(B) has been formed and maintained in
good faith for purposes other than obtaining
insurance;
(C) does not condition membership in the
association on any health status-related fac-

Page 1339

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tor relating to an individual (including an
employee of an employer or a dependent of
an employee);
(D) makes health insurance coverage offered through the association available to
all members regardless of any health statusrelated factor relating to such members (or
individuals eligible for coverage through a
member);
(E) does not make health insurance coverage offered through the association available other than in connection with a member of the association; and
(F) meets such additional requirements as
may be imposed under State law.
(4) COBRA continuation provision
The term ‘‘COBRA continuation provision’’
means any of the following:
(A) Section 4980B of title 26, other than
subsection (f)(1) of such section insofar as it
relates to pediatric vaccines.
(B) Part 6 of subtitle B of title I of the Employee Retirement Income Security Act of
1974 [29 U.S.C. 1161 et seq.], other than section 609 of such Act [29 U.S.C. 1169].
(C) Subchapter XX of this chapter.
(5) Employee
The term ‘‘employee’’ has the meaning given
such term under section 3(6) of the Employee
Retirement Income Security Act of 1974 [29
U.S.C. 1002(6)].
(6) Employer
The term ‘‘employer’’ has the meaning given
such term under section 3(5) of the Employee
Retirement Income Security Act of 1974 [29
U.S.C. 1002(5)], except that such term shall include only employers of two or more employees.
(7) Church plan
The term ‘‘church plan’’ has the meaning
given such term under section 3(33) of the Employee Retirement Income Security Act of 1974
[29 U.S.C. 1002(33)].
(8) Governmental plan
(A) The term ‘‘governmental plan’’ has the
meaning given such term under section 3(32) of
the Employee Retirement Income Security
Act of 1974 [29 U.S.C. 1002(32)] and any Federal
governmental plan.
(B) FEDERAL GOVERNMENTAL PLAN.—The
term ‘‘Federal governmental plan’’ means a
governmental plan established or maintained
for its employees by the Government of the
United States or by any agency or instrumentality of such Government.
(C) NON-FEDERAL GOVERNMENTAL PLAN.—The
term ‘‘non-Federal governmental plan’’ means
a governmental plan that is not a Federal governmental plan.
(9) Health status-related factor
The term ‘‘health status-related factor’’
means any of the factors described in section
2702(a)(1).1
(10) Network plan
The term ‘‘network plan’’ means health insurance coverage of a health insurance issuer

§ 300gg–91

under which the financing and delivery of
medical care (including items and services
paid for as medical care) are provided, in
whole or in part, through a defined set of providers under contract with the issuer.
(11) Participant
The term ‘‘participant’’ has the meaning
given such term under section 3(7) of the Employee Retirement Income Security Act of 1974
[29 U.S.C. 1002(7)].
(12) Placed for adoption defined
The term ‘‘placement’’, or being ‘‘placed’’,
for adoption, in connection with any placement for adoption of a child with any person,
means the assumption and retention by such
person of a legal obligation for total or partial
support of such child in anticipation of adoption of such child. The child’s placement with
such person terminates upon the termination
of such legal obligation.
(13) Plan sponsor
The term ‘‘plan sponsor’’ has the meaning
given such term under section 3(16)(B) of the
Employee Retirement Income Security Act of
1974 [29 U.S.C. 1002(16)(B)].
(14) State
The term ‘‘State’’ means each of the several
States, the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa,
and the Northern Mariana Islands.
(15) Family member
The term ‘‘family member’’ means, with respect to any individual—
(A) a dependent (as such term is used for
purposes of section 2701(f)(2)) 1 of such individual; and
(B) any other individual who is a first-degree, second-degree, third-degree, or fourthdegree relative of such individual or of an individual described in subparagraph (A).
(16) Genetic information
(A) In general
The term ‘‘genetic information’’ means,
with respect to any individual, information
about—
(i) such individual’s genetic tests,
(ii) the genetic tests of family members
of such individual, and
(iii) the manifestation of a disease or disorder in family members of such individual.
(B) Inclusion of genetic services and participation in genetic research
Such term includes, with respect to any
individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by
such individual or any family member of
such individual.
(C) Exclusions
The term ‘‘genetic information’’ shall not
include information about the sex or age of
any individual.
(17) Genetic test
(A) In general
The term ‘‘genetic test’’ means an analysis
of human DNA, RNA, chromosomes, pro-

§ 300gg–91
teins,
or
genotypes,
changes.

TITLE 42—THE PUBLIC HEALTH AND WELFARE
metabolites,
that
detects
mutations, or chromosomal

(B) Exceptions
The term ‘‘genetic test’’ does not mean—
(i) an analysis of proteins or metabolites
that does not detect genotypes, mutations,
or chromosomal changes; or
(ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological
condition that could reasonably be detected by a health care professional with
appropriate training and expertise in the
field of medicine involved.
(18) Genetic services
The term ‘‘genetic services’’ means—
(A) a genetic test;
(B) genetic counseling (including obtaining, interpreting, or assessing genetic information); or
(C) genetic education.
(19) Underwriting purposes
The term ‘‘underwriting purposes’’ means,
with respect to any group health plan, or
health insurance coverage offered in connection with a group health plan—
(A) rules for, or determination of, eligibility (including enrollment and continued
eligibility) for benefits under the plan or
coverage;
(B) the computation of premium or contribution amounts under the plan or coverage;
(C) the application of any pre-existing condition exclusion under the plan or coverage;
and
(D) other activities related to the creation,
renewal, or replacement of a contract of
health insurance or health benefits.
(20) Qualified health plan
The term ‘‘qualified health plan’’ has the
meaning given such term in section 18021(a) of
this title.
(21) Exchange
The term ‘‘Exchange’’ means an American
Health Benefit Exchange established under
section 18031 of this title.
(e) Definitions relating to markets and small employers
For purposes of this subchapter:
(1) Individual market
(A) In general
The term ‘‘individual market’’ means the
market for health insurance coverage offered to individuals other than in connection
with a group health plan.
(B) Treatment of very small groups
(i) In general
Subject to clause (ii), such terms 2 includes coverage offered in connection with
a group health plan that has fewer than

two participants as current employees on
the first day of the plan year.
(ii) State exception
Clause (i) shall not apply in the case of
a State that elects to regulate the coverage described in such clause as coverage
in the small group market.
(2) Large employer
The term ‘‘large employer’’ means, in connection with a group health plan with respect
to a calendar year and a plan year, an employer who employed an average of at least 101
employees on business days during the preceding calendar year and who employs at least 2
employees on the first day of the plan year.
(3) Large group market
The term ‘‘large group market’’ means the
health insurance market under which individuals obtain health insurance coverage (directly or through any arrangement) on behalf
of themselves (and their dependents) through
a group health plan maintained by a large employer.
(4) Small employer
The term ‘‘small employer’’ means, in connection with a group health plan with respect
to a calendar year and a plan year, an employer who employed an average of at least 1
but not more than 100 employees on business
days during the preceding calendar year and
who employs at least 1 employees 3 on the first
day of the plan year.
(5) Small group market
The term ‘‘small group market’’ means the
health insurance market under which individuals obtain health insurance coverage (directly or through any arrangement) on behalf
of themselves (and their dependents) through
a group health plan maintained by a small employer.
(6) Application of certain rules in determination of employer size
For purposes of this subsection—
(A) Application of aggregation rule for employers
all 4 persons treated as a single employer
under subsection (b), (c), (m), or (o) of section 414 of title 26 shall be treated as 1 employer.
(B) Employers not in existence in preceding
year
In the case of an employer which was not
in existence throughout the preceding calendar year, the determination of whether
such employer is a small or large employer
shall be based on the average number of employees that it is reasonably expected such
employer will employ on business days in
the current calendar year.
(C) Predecessors
Any reference in this subsection to an employer shall include a reference to any predecessor of such employer.
3 So

2 So

in original. Probably should be ‘‘term’’.

Page 1340

4 So

in original.
in original. Probably should be capitalized.

Page 1341

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XXVII, § 2791, as added
Pub. L. 104–191, title I, § 102(a), Aug. 21, 1996, 110
Stat. 1972; amended Pub. L. 110–233, title I,
§ 102(a)(4), May 21, 2008, 122 Stat. 890; Pub. L.
111–148, title I, § 1563(b), (c)(16), formerly § 1562(b),
(c)(16), title X, § 10107(b)(1), Mar. 23, 2010, 124
Stat. 264, 269, 911.)
REFERENCES IN TEXT
Section 2701, referred to in subsecs. (a)(3) and
(d)(15)(A), is a reference to section 2701 of act July 1,
1944. Section 2701, which was classified to section 300gg
of this title, was renumbered section 2704, effective for
plan years beginning on or after Jan. 1, 2014, with certain exceptions, and amended, by Pub. L. 111–148, title
I, §§ 1201(2), 1563(c)(1), formerly § 1562(c)(1), title X,
§ 10107(b)(1), Mar. 23, 2010, 124 Stat. 154, 264, 911, and was
transferred to section 300gg–3 of this title. A new section 2701 of act July 1, 1944, related to fair health insurance premiums, was added, effective for plan years beginning on or after Jan. 1, 2014, and amended, by Pub.
L. 111–148, title I, § 1201(4), title X, § 10103(a), Mar. 23,
2010, 124 Stat. 155, 892, and is classified to section 300gg
of this title.
The Employee Retirement Income Security Act of
1974, referred to in subsec. (d)(4)(B), is Pub. L. 93–406,
Sept. 2, 1974, 88 Stat. 829, as amended. Part 6 of subtitle
B of title I of the Act is classified generally to part 6
(§ 1161 et seq.) of subtitle B of subchapter I of chapter
18 of Title 29, Labor. For complete classification of this
Act to the Code, see Short Title note set out under section 1001 of Title 29 and Tables.
Section 2702, referred to in subsec. (d)(9), is a reference to section 2702 of act July 1, 1944. Section 2702,
which was classified to section 300gg–1 of this title, was
amended by Pub. L. 111–148, title I, § 1201(3), Mar. 23,
2010, 124 Stat. 154, and was transferred to subsecs. (d) to
(f) of section 300gg–4 of this title, effective for plan
years beginning on or after Jan. 1, 2014. A new section
2702, related to guaranteed availability of coverage, was
added by Pub. L. 111–148, title I, § 1201(4), Mar. 23, 2010,
124 Stat. 156, effective for plan years beginning on or
after Jan. 1, 2014, and is classified to section 300gg–1 of
this title.
AMENDMENTS
2010—Subsec. (d)(20), (21). Pub. L. 111–148, § 1563(b), formerly § 1562(b), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), added pars. (20) and (21).
Subsec. (e)(2). Pub. L. 111–148, § 1563(c)(16)(A), formerly § 1562(c)(16)(A), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘101’’ for ‘‘51’’.
Subsec. (e)(4). Pub. L. 111–148, § 1563(c)(16)(B), formerly
§ 1562(c)(16)(B), as renumbered by Pub. L. 111–148,
§ 10107(b)(1), substituted ‘‘100’’ for ‘‘50’’ and ‘‘at least 1’’
for ‘‘at least 2’’ in two places.
2008—Subsec. (d)(15) to (19). Pub. L. 110–233 added
pars. (15) to (19).
EFFECTIVE DATE OF 2008 AMENDMENT
Amendment by Pub. L. 110–233 applicable, with respect to group health plans and health insurance coverage offered in connection with group health plans, for
plan years beginning after the date that is one year
after May 21, 2008, and, with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the individual market, after the date that is
one year after May 21, 2008, see section 102(d)(2) of Pub.
L. 110–233, set out as a note under section 300gg–21 of
this title.

§ 300gg–92. Regulations
The Secretary, consistent with section 104 of
the Health Care Portability and Accountability
Act of 1996, may promulgate such regulations as
may be necessary or appropriate to carry out
the provisions of this subchapter. The Secretary

§ 300gg–93

may promulgate any interim final rules as the
Secretary determines are appropriate to carry
out this subchapter.
(July 1, 1944, ch. 373, title XXVII, § 2792, as added
Pub. L. 104–191, title I, § 102(a), Aug. 21, 1996, 110
Stat. 1976.)
REFERENCES IN TEXT
Section 104 of the Health Care Portability and Accountability Act of 1996, referred to in text, probably
means section 104 of the Health Insurance Portability
and Accountability Act of 1996, Pub. L. 104–191, set out
below.
ASSURING COORDINATION AMONG DEPARTMENTS OF
TREASURY, HEALTH AND HUMAN SERVICES, AND LABOR
Section 104 of Pub. L. 104–191 provided that: ‘‘The
Secretary of the Treasury, the Secretary of Health and
Human Services, and the Secretary of Labor shall ensure, through the execution of an interagency memorandum of understanding among such Secretaries,
that—
‘‘(1) regulations, rulings, and interpretations issued
by such Secretaries relating to the same matter over
which two or more such Secretaries have responsibility under this subtitle [subtitle A (§§ 101–104) of title
I of Pub. L. 104–191, enacting this section, sections
300gg, 300gg–1, 300gg–11 to 300gg–13, 300gg–21 to
300gg–23, and 300gg–91 of this title, and sections 1181
to 1183 and 1191 to 1191c of Title 29, Labor, amending
sections 300e and 300bb–8 of this title and sections
1003, 1021, 1022, 1024, 1132, 1136, and 1144 of Title 29, and
enacting provisions set out as notes under section
300gg of this title and section 1181 of Title 29] (and the
amendments made by this subtitle and section 401
[enacting sections 9801 to 9806 of Title 26, Internal
Revenue Code]) are administered so as to have the
same effect at all times; and
‘‘(2) coordination of policies relating to enforcing
the same requirements through such Secretaries in
order to have a coordinated enforcement strategy
that avoids duplication of enforcement efforts and assigns priorities in enforcement.’’

§ 300gg–93. Health insurance consumer information
(a) In general
The Secretary shall award grants to States to
enable such States (or the Exchanges operating
in such States) to establish, expand, or provide
support for—
(1) offices of health insurance consumer assistance; or
(2) health insurance ombudsman programs.
(b) Eligibility
(1) In general
To be eligible to receive a grant, a State
shall designate an independent office of health
insurance consumer assistance, or an ombudsman, that, directly or in coordination with
State health insurance regulators and consumer assistance organizations, receives and
responds to inquiries and complaints concerning health insurance coverage with respect to
Federal health insurance requirements and
under State law.
(2) Criteria
A State that receives a grant under this section shall comply with criteria established by
the Secretary for carrying out activities under
such grant.
(c) Duties
The office of health insurance consumer assistance or health insurance ombudsman shall—

§ 300gg–94

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(1) assist with the filing of complaints and
appeals, including filing appeals with the internal appeal or grievance process of the group
health plan or health insurance issuer involved and providing information about the
external appeal process;
(2) collect, track, and quantify problems and
inquiries encountered by consumers;
(3) educate consumers on their rights and responsibilities with respect to group health
plans and health insurance coverage;
(4) assist consumers with enrollment in a
group health plan or health insurance coverage by providing information, referral, and
assistance; and
(5) resolve problems with obtaining premium
tax credits under section 36B of title 26.
(d) Data collection
As a condition of receiving a grant under subsection (a), an office of health insurance consumer assistance or ombudsman program shall
be required to collect and report data to the
Secretary on the types of problems and inquiries
encountered by consumers. The Secretary shall
utilize such data to identify areas where more
enforcement action is necessary and shall share
such information with State insurance regulators, the Secretary of Labor, and the Secretary of the Treasury for use in the enforcement activities of such agencies.
(e) Funding
(1) Initial funding
There is hereby appropriated to the Secretary, out of any funds in the Treasury not
otherwise appropriated, $30,000,000 for the first
fiscal year for which this section applies to
carry out this section. Such amount shall remain available without fiscal year limitation.
(2) Authorization for subsequent years
There is authorized to be appropriated to the
Secretary for each fiscal year following the
fiscal year described in paragraph (1), such
sums as may be necessary to carry out this
section.
(July 1, 1944, ch. 373, title XXVII, § 2793, as added
Pub. L. 111–148, title I, § 1002, Mar. 23, 2010, 124
Stat. 138.)
EFFECTIVE DATE
Section effective for fiscal years beginning with fiscal
year 2010, see section 1004(a) of Pub. L. 111–148, set out
as a note under section 300gg–11 of this title.
Section effective Mar. 23, 2010, see section 1004(b) of
Pub. L. 111–148, set out as a note under section 300gg–11
of this title.

§ 300gg–94. Ensuring that consumers get value
for their dollars
(a) Initial premium review process
(1) In general
The Secretary, in conjunction with States,
shall establish a process for the annual review,
beginning with the 2010 plan year and subject
to subsection (b)(2)(A), of unreasonable increases in premiums for health insurance coverage.
(2) Justification and disclosure
The process established under paragraph (1)
shall require health insurance issuers to sub-

Page 1342

mit to the Secretary and the relevant State a
justification for an unreasonable premium increase prior to the implementation of the increase. Such issuers shall prominently post
such information on their Internet websites.
The Secretary shall ensure the public disclosure of information on such increases and justifications for all health insurance issuers.
(b) Continuing premium review process
(1) Informing Secretary of premium increase
patterns
As a condition of receiving a grant under
subsection (c)(1), a State, through its Commissioner of Insurance, shall—
(A) provide the Secretary with information about trends in premium increases in
health insurance coverage in premium rating areas in the State; and
(B) make recommendations, as appropriate, to the State Exchange about whether
particular health insurance issuers should be
excluded from participation in the Exchange
based on a pattern or practice of excessive or
unjustified premium increases.
(2) Monitoring by Secretary of premium increases
(A) In general
Beginning with plan years beginning in
2014, the Secretary, in conjunction with the
States and consistent with the provisions of
subsection (a)(2), shall monitor premium increases of health insurance coverage offered
through an Exchange and outside of an Exchange.
(B) Consideration in opening Exchange
In determining under section 18032(f)(2)(B)
of this title whether to offer qualified health
plans in the large group market through an
Exchange, the State shall take into account
any excess of premium growth outside of the
Exchange as compared to the rate of such
growth inside the Exchange.
(c) Grants in support of process
(1) Premium review grants during 2010
through 2014
The Secretary shall carry out a program to
award grants to States during the 5-year period beginning with fiscal year 2010 to assist
such States in carrying out subsection (a), including—
(A) in reviewing and, if appropriate under
State law, approving premium increases for
health insurance coverage;
(B) in providing information and recommendations to the Secretary under subsection (b)(1); and
(C) in establishing centers (consistent with
subsection (d)) at academic or other nonprofit institutions to collect medical reimbursement information from health insurance issuers, to analyze and organize such
information, and to make such information
available to such issuers, health care providers, health researchers, health care policy
makers, and the general public.
(2) Funding
(A) In general
Out of all funds in the Treasury not otherwise appropriated, there are appropriated to

Page 1343

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the Secretary $250,000,000, to be available for
expenditure for grants under paragraph (1)
and subparagraph (B).
(B) Further availability for insurance reform
and consumer protection
If the amounts appropriated under subparagraph (A) are not fully obligated under
grants under paragraph (1) by the end of fiscal year 2014, any remaining funds shall remain available to the Secretary for grants
to States for planning and implementing the
insurance reforms and consumer protections
under part A.
(C) Allocation
The Secretary shall establish a formula for
determining the amount of any grant to a
State under this subsection. Under such formula—
(i) the Secretary shall consider the number of plans of health insurance coverage
offered in each State and the population of
the State; and
(ii) no State qualifying for a grant under
paragraph (1) shall receive less than
$1,000,000, or more than $5,000,000 for a
grant year.
(d) Medical reimbursement data centers
(1) Functions
A center established under subsection
(c)(1)(C) shall—
(A) develop fee schedules and other database tools that fairly and accurately reflect
market rates for medical services and the
geographic differences in those rates;
(B) use the best available statistical methods and data processing technology to develop such fee schedules and other database
tools;
(C) regularly update such fee schedules and
other database tools to reflect changes in
charges for medical services;
(D) make health care cost information
readily available to the public through an
Internet website that allows consumers to
understand the amounts that health care
providers in their area charge for particular
medical services; and
(E) regularly publish information concerning the statistical methodologies used by
the center to analyze health charge data and
make such data available to researchers and
policy makers.
(2) Conflicts of interest
A center established under subsection
(c)(1)(C) shall adopt by-laws that ensures that
the center (and all members of the governing
board of the center) is independent and free
from all conflicts of interest. Such by-laws
shall ensure that the center is not controlled
or influenced by, and does not have any corporate relation to, any individual or entity
that may make or receive payments for health
care services based on the center’s analysis of
health care costs.
(3) Rule of construction
Nothing in this subsection shall be construed to permit a center established under

§ 300hh

subsection (c)(1)(C) to compel health insurance
issuers to provide data to the center.
(July 1, 1944, ch. 373, title XXVII, § 2794, as added
and amended Pub. L. 111–148, title I, § 1003, title
X, § 10101(i), Mar. 23, 2010, 124 Stat. 139, 891.)
CODIFICATION
Another section 2794 of act July 1, 1944, is classified
to section 300gg–95 of this title.
AMENDMENTS
2010—Subsec. (c)(1)(C). Pub. L. 111–148, § 10101(i)(1),
added subpar. (C).
Subsec. (d). Pub. L. 111–148, § 10101(i)(2), added subsec.
(d).
EFFECTIVE DATE
Section effective for fiscal years beginning with fiscal
year 2010, see section 1004(a) of Pub. L. 111–148, set out
as a note under section 300gg–11 of this title.
Section effective Mar. 23, 2010, see section 1004(b) of
Pub. L. 111–148, set out as a note under section 300gg–11
of this title.

§ 300gg–95. Uniform fraud and abuse referral format
The Secretary shall request the National Association of Insurance Commissioners to develop
a model uniform report form for private health
insurance issuer 1 seeking to refer suspected
fraud and abuse to State insurance departments
or other responsible State agencies for investigation. The Secretary shall request that the
National Association of Insurance Commissioners develop recommendations for uniform
reporting standards for such referrals.
(July 1, 1944, ch. 373, title XXVII, § 2794, as added
Pub. L. 111–148, title VI, § 6603, Mar. 23, 2010, 124
Stat. 780.)
CODIFICATION
Another section 2794 of act July 1, 1944, is classified
to section 300gg–94 of this title.

SUBCHAPTER XXVI—NATIONAL ALL-HAZARDS
PREPAREDNESS
FOR
PUBLIC
HEALTH EMERGENCIES
AMENDMENTS
2006—Pub. L. 109–417, title I, § 101(1), Dec. 19, 2006, 120
Stat. 2832, substituted ‘‘NATIONAL ALL-HAZARDS
PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES’’ for ‘‘NATIONAL PREPAREDNESS FOR
BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES’’ in heading.

PART

A—NATIONAL ALL-HAZARDS PREPAREDNESS AND RESPONSE PLANNING, COORDINATING,
AND REPORTING
AMENDMENTS

2006—Pub. L. 109–417, title I, § 101(2), Dec. 19, 2006, 120
Stat. 2832, substituted ‘‘National All-Hazards Preparedness’’ for ‘‘National Preparedness’’ in heading.

§ 300hh. Public health and medical preparedness
and response functions
(a) In general
The Secretary of Health and Human Services
shall lead all Federal public health and medical
1 So

in original. Probably should be ‘‘issuers’’.

§ 300hh–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

response to public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(6) 1 of title 6, or
any successor plan.
(b) Interagency agreement
The Secretary, in collaboration with the Secretary of Veterans Affairs, the Secretary of
Transportation, the Secretary of Defense, the
Secretary of Homeland Security, and the head of
any other relevant Federal agency, shall establish an interagency agreement, consistent with
the National Response Plan or any successor
plan, under which agreement the Secretary of
Health and Human Services shall assume operational control of emergency public health and
medical response assets, as necessary, in the
event of a public health emergency, except that
members of the armed forces under the authority of the Secretary of Defense shall remain
under the command and control of the Secretary
of Defense, as shall any associated assets of the
Department of Defense.
(July 1, 1944, ch. 373, title XXVIII, § 2801, as
added Pub. L. 107–188, title I, § 101(a), June 12,
2002, 116 Stat. 596; amended Pub. L. 109–417, title
I, § 101(2), Dec. 19, 2006, 120 Stat. 2832.)
REFERENCES IN TEXT
Section 314(6) of title 6, referred to in subsec. (a), was
in the original ‘‘section 502(6) of the Homeland Security
Act of 2002’’, and was translated as meaning section
504(6) of Pub. L. 107–296, to reflect the probable intent
of Congress and the renumbering of section 502 as 504
by Pub. L. 109–295, title VI, § 611(8), Oct. 4, 2006, 120 Stat.
1395.
AMENDMENTS
2006—Pub. L. 109–417 amended section generally. Prior
to amendment, section consisted of subsecs. (a) to (d)
relating to a national preparedness plan for carrying
out health-related activities to prepare for and respond
effectively to bioterrorism and other public health
emergencies.
GOVERNMENT ACCOUNTABILITY OFFICE REPORT
Pub. L. 107–188, title I, § 157, June 12, 2002, 116 Stat.
633, provided that:
‘‘(a) IN GENERAL [sic].—The Comptroller General
shall submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the Senate, and to the Committee on Energy
and Commerce and the Committee on Appropriations of
the House of Representatives, a report that describes—
‘‘(1) Federal activities primarily related to research
on, preparedness for, and the management of the public health and medical consequences of a bioterrorist
attack against the civilian population;
‘‘(2) the coordination of the activities described in
paragraph (1);
‘‘(3) the effectiveness of such efforts in preparing
national, State, and local authorities to address the
public health and medical consequences of a potential
bioterrorist attack against the civilian population;
‘‘(4) the activities and costs of the Civil Support
Teams of the National Guard in responding to biological threats or attacks against the civilian population;
‘‘(5) the activities of the working group under subsection (a) and the efforts made by such group to
carry out the activities described in such subsection;
and
‘‘(6) the ability of private sector contractors to enhance governmental responses to biological threats
or attacks.’’
1 See

References in Text note below.

Page 1344

§ 300hh–1. National Health Security Strategy
(a) In general
(1) Preparedness and response regarding public health emergencies
Beginning in 2009 and every four years thereafter, the Secretary shall prepare and submit
to the relevant committees of Congress a coordinated strategy (to be known as the National
Health Security Strategy) and any revisions
thereof, and an accompanying implementation
plan for public health emergency preparedness
and response. Such National Health Security
Strategy shall identify the process for achieving the preparedness goals described in subsection (b) and shall be consistent with the
National Preparedness Goal, the National Incident Management System, and the National
Response Plan developed pursuant to section
314(6) 1 of title 6, or any successor plan.
(2) Evaluation of progress
The National Health Security Strategy shall
include an evaluation of the progress made by
Federal, State, local, and tribal entities, based
on the evidence-based benchmarks and objective standards that measure levels of preparedness established pursuant to section
247d–3a(g) of this title. Such evaluation shall
include aggregate and State-specific breakdowns of obligated funding spent by major category (as defined by the Secretary) for activities funded through awards pursuant to sections 247d–3a and 247d–3b of this title.
(3) Public health workforce
In 2009, the National Health Security Strategy shall include a national strategy for establishing an effective and prepared public health
workforce, including defining the functions,
capabilities, and gaps in such workforce, and
identifying strategies to recruit, retain, and
protect such workforce from workplace exposures during public health emergencies.
(b) Preparedness goals
The National Health Security Strategy shall
include provisions in furtherance of the following:
(1) Integration
Integrating public health and public and private medical capabilities with other first responder systems, including through—
(A) the periodic evaluation of Federal,
State, local, and tribal preparedness and response capabilities through drills and exercises; and
(B) integrating public and private sector
public health and medical donations and volunteers.
(2) Public health
Developing and sustaining Federal, State,
local, and tribal essential public health security capabilities, including the following:
(A) Disease situational awareness domestically and abroad, including detection, identification, and investigation.
(B) Disease containment including capabilities for isolation, quarantine, social
distancing, and decontamination.
1 See

References in Text note below.

Page 1345

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) Risk communication and public preparedness.
(D) Rapid distribution and administration
of medical countermeasures.
(3) Medical
Increasing the preparedness, response capabilities, and surge capacity of hospitals, other
health care facilities (including mental health
facilities), and trauma care and emergency
medical service systems, with respect to public health emergencies, which shall include developing plans for the following:
(A) Strengthening public health emergency medical management and treatment
capabilities.
(B) Medical evacuation and fatality management.
(C) Rapid distribution and administration
of medical countermeasures.
(D) Effective utilization of any available
public and private mobile medical assets and
integration of other Federal assets.
(E) Protecting health care workers and
health care first responders from workplace
exposures during a public health emergency.
(4) At-risk individuals
(A) Taking into account the public health
and medical needs of at-risk individuals in the
event of a public health emergency.
(B) For purpose of this section and sections
247d–3a, 247d–6, and 247d–7e of this title, the
term ‘‘at-risk individuals’’ means children,
pregnant women, senior citizens and other individuals who have special needs in the event
of a public health emergency, as determined
by the Secretary.
(5) Coordination
Minimizing duplication of, and ensuring coordination between, Federal, State, local, and
tribal planning, preparedness, and response activities (including the State Emergency Management Assistance Compact). Such planning
shall be consistent with the National Response
Plan, or any successor plan, and National Incident Management System and the National
Preparedness Goal.
(6) Continuity of operations
Maintaining vital public health and medical
services to allow for optimal Federal, State,
local, and tribal operations in the event of a
public health emergency.
(July 1, 1944, ch. 373, title XXVIII, § 2802, as
added Pub. L. 109–417, title I, § 103, Dec. 19, 2006,
120 Stat. 2835.)
REFERENCES IN TEXT
Section 314(6) of title 6, referred to in subsec. (a)(1),
was in the original ‘‘section 502(6) of the Homeland Security Act of 2002’’, and was translated as meaning section 504(6) of Pub. L. 107–296, to reflect the probable intent of Congress and the renumbering of section 502 as
504 by Pub. L. 109–295, title VI, § 611(8), Oct. 4, 2006, 120
Stat. 1395.
EX. ORD. NO. 13527. ESTABLISHING FEDERAL CAPABILITY
FOR THE TIMELY PROVISION OF MEDICAL COUNTERMEASURES FOLLOWING A BIOLOGICAL ATTACK
Ex. Ord. No. 13527, Dec. 30, 2009, 75 F.R. 737, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:

§ 300hh–1

SECTION 1. Policy. It is the policy of the United States
to plan and prepare for the timely provision of medical
countermeasures to the American people in the event
of a biological attack in the United States through a
rapid Federal response in coordination with State,
local, territorial, and tribal governments.
This policy would seek to: (1) mitigate illness and
prevent death; (2) sustain critical infrastructure; and
(3) complement and supplement State, local, territorial, and tribal government medical countermeasure
distribution capacity.
SEC. 2. United States Postal Service Delivery of Medical
Countermeasures. (a) The U.S. Postal Service has the capacity for rapid residential delivery of medical countermeasures for self administration across all communities in the United States. The Federal Government
shall pursue a national U.S. Postal Service medical
countermeasures dispensing model to respond to a
large-scale biological attack.
(b) The Secretaries of Health and Human Services
and Homeland Security, in coordination with the U.S.
Postal Service, within 180 days of the date of this order,
shall establish a national U.S. Postal Service medical
countermeasures dispensing model for U.S. cities to respond to a large-scale biological attack, with anthrax
as the primary threat consideration.
(c) In support of the national U.S. Postal Service
model, the Secretaries of Homeland Security, Health
and Human Services, and Defense, and the Attorney
General, in coordination with the U.S. Postal Service,
and in consultation with State and local public health,
emergency management, and law enforcement officials,
within 180 days of the date of this order, shall develop
an accompanying plan for supplementing local law enforcement personnel, as necessary and appropriate,
with local Federal law enforcement, as well as other
appropriate personnel, to escort U.S. Postal workers
delivering medical countermeasures.
SEC. 3. Federal Rapid Response. (a) The Federal Government must develop the capacity to anticipate and
immediately supplement the capabilities of affected jurisdictions to rapidly distribute medical countermeasures following a biological attack. Implementation of a Federal strategy to rapidly dispense medical
countermeasures requires establishment of a Federal
rapid response capability.
(b) The Secretaries of Homeland Security and Health
and Human Services, in coordination with the Secretary of Defense, within 90 days of the date of this
order, shall develop a concept of operations and establish requirements for a Federal rapid response to dispense medical countermeasures to an affected population following a large-scale biological attack.
SEC. 4. Continuity of Operations. (a) The Federal Government must establish mechanisms for the provision
of medical countermeasures to personnel performing
mission-essential functions to ensure that mission-essential functions of Federal agencies continue to be
performed following a biological attack.
(b) The Secretaries of Health and Human Services
and Homeland Security, within 180 days of the date of
this order, shall develop a plan for the provision of
medical countermeasures to ensure that mission-essential functions of executive branch departments and
agencies continue to be performed following a largescale biological attack.
SEC. 5. General Provisions.
(a) Nothing in this order shall be construed to impair
or otherwise affect:
(i) authority granted by law to a department or agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the

§ 300hh–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Page 1346

United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
BARACK OBAMA.

§ 300hh–10. Coordination of preparedness for and
response to all-hazards public health emergencies

§ 300hh–2. Enhancing medical surge capacity

(a) In general
There is established within the Department of
Health and Human Services the position of the
Assistant Secretary for Preparedness and Response. The President, with the advice and consent of the Senate, shall appoint an individual
to serve in such position. Such Assistant Secretary shall report to the Secretary.
(b) Duties
Subject to the authority of the Secretary, the
Assistant Secretary for Preparedness and Response shall carry out the following functions:
(1) Leadership
Serve as the principal advisor to the Secretary on all matters related to Federal public
health and medical preparedness and response
for public health emergencies.
(2) Personnel
Register, credential, organize, train, equip,
and have the authority to deploy Federal public health and medical personnel under the authority of the Secretary, including the National Disaster Medical System, and coordinate such personnel with the Medical Reserve
Corps and the Emergency System for Advance
Registration of Volunteer Health Professionals.
(3) Countermeasures
Oversee advanced research, development,
and procurement of qualified countermeasures
(as defined in section 247d–6a of this title) and
qualified pandemic or epidemic products (as
defined in section 247d–6d of this title).
(4) Coordination
(A) Federal integration
Coordinate with relevant Federal officials
to ensure integration of Federal preparedness and response activities for public health
emergencies.
(B) State, local, and tribal integration
Coordinate with State, local, and tribal
public health officials, the Emergency Management Assistance Compact, health care
systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during
a public health emergency.
(C) Emergency medical services
Promote improved emergency medical
services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with
regard to public health emergencies.
(5) Logistics
In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and
other public and private entities, provide
logistical support for medical and public
health aspects of Federal responses to public
health emergencies.

(a) Study of enhancing medical surge capacity
As part of the joint review described in section
300hh–11(b) of this title, the Secretary shall
evaluate the benefits and feasibility of improving the capacity of the Department of Health
and Human Services to provide additional medical surge capacity to local communities in the
event of a public health emergency. Such study
shall include an assessment of the need for and
feasibility
of
improving
surge
capacity
through—
(1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on
a contingency basis, to a community in the
event of a public health emergency;
(2) integrating the practice of telemedicine
within the National Disaster Medical System;
and
(3) other strategies to improve such capacity
as determined appropriate by the Secretary.
(b) Authority to acquire and operate mobile medical assets
In addition to any other authority to acquire,
deploy, and operate mobile medical assets, the
Secretary may acquire, deploy, and operate mobile medical assets if, taking into consideration
the evaluation conducted under subsection (a),
such acquisition, deployment, and operation is
determined to be beneficial and feasible in improving the capacity of the Department of
Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency.
(c) Using Federal facilities to enhance medical
surge capacity
(1) Analysis
The Secretary shall conduct an analysis of
whether there are Federal facilities which, in
the event of a public health emergency, could
practicably be used as facilities in which to
provide health care.
(2) Memoranda of understanding
If, based on the analysis conducted under
paragraph (1), the Secretary determines that
there are Federal facilities which, in the event
of a public health emergency, could be used as
facilities in which to provide health care, the
Secretary shall, with respect to each such facility, seek to conclude a memorandum of understanding with the head of the Department
or agency that operates such facility that permits the use of such facility to provide health
care in the event of a public health emergency.
(July 1, 1944, ch. 373, title XXVIII, § 2803, as
added Pub. L. 109–417, title III, § 302(a), Dec. 19,
2006, 120 Stat. 2855.)
PART B—ALL-HAZARDS EMERGENCY
PREPAREDNESS AND RESPONSE
AMENDMENTS
2006—Pub. L. 109–417, title I, § 102(a)(1), Dec. 19, 2006,
120 Stat. 2832, inserted ‘‘All-Hazards’’ before ‘‘Emergency Preparedness’’ in heading.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(6) Leadership
Provide leadership in international programs, initiatives, and policies that deal with
public health and medical emergency preparedness and response.
(c) Functions
The Assistant Secretary for Preparedness and
Response shall—
(1) have authority over and responsibility
for—
(A) the National Disaster Medical System
(in accordance with section 301 of the Pandemic and All-Hazards Preparedness Act);
and
(B) the Hospital Preparedness Cooperative
Agreement Program pursuant to section
247d–3b of this title;
(2) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—
(A) the Medical Reserve Corps pursuant to
section 300hh–15 of this title;
(B) the Emergency System for Advance
Registration of Volunteer Health Professionals pursuant to section 247d–7b of this
title;
(C) the Strategic National Stockpile; and
(D) the Cities Readiness Initiative; and
(3) assume other duties as determined appropriate by the Secretary.
(July 1, 1944, ch. 373, title XXVIII, § 2811, as
added Pub. L. 109–417, title I, § 102(a)(3), Dec. 19,
2006, 120 Stat. 2833.)
REFERENCES IN TEXT
Section 301 of the Pandemic and All-Hazards Preparedness Act, referred to in subsec. (c)(1)(A), is section
301 of Pub. L. 109–417, title III, Dec. 19, 2006, 120 Stat.
2853, which amended sections 247d–6 and 300hh–11 of this
title and sections 313 and 314 of Title 6, Domestic Security, and enacted provisions set out as notes under section 300hh–11 of this title and section 313 of Title 6.
PRIOR PROVISIONS
A prior section 2811 of act July 1, 1944, was renumbered section 2812 and is classified to section 300hh–11
of this title.
TRANSFER OF FUNCTIONS
Pub. L. 109–417, title I, § 102(b), Dec. 19, 2006, 120 Stat.
2834, provided that:
‘‘(1) TRANSFER OF FUNCTIONS.—There shall be transferred to the Office of the Assistant Secretary for Preparedness and Response the functions, personnel, assets, and liabilities of the Assistant Secretary for Public Health Emergency Preparedness as in effect on the
day before the date of enactment of this Act [Dec. 19,
2006].
‘‘(2) REFERENCES.—Any reference in any Federal law,
Executive order, rule, regulation, or delegation of authority, or any document of or pertaining to the Assistant Secretary for Public Health Emergency Preparedness as in effect the day before the date of enactment
of this Act, shall be deemed to be a reference to the Assistant Secretary for Preparedness and Response.’’

§ 300hh–11. National Disaster Medical System
(a) National Disaster Medical System
(1) In general
The Secretary shall provide for the operation in accordance with this section of a sys-

§ 300hh–11

tem to be known as the National Disaster
Medical System. The Secretary shall designate the Assistant Secretary for Preparedness and Response as the head of the National
Disaster Medical System, subject to the authority of the Secretary.
(2) Federal and State collaborative System
(A) In general
The National Disaster Medical System
shall be a coordinated effort by the Federal
agencies specified in subparagraph (B),
working in collaboration with the States
and other appropriate public or private entities, to carry out the purposes described in
paragraph (3).
(B) Participating Federal agencies
The Federal agencies referred to in subparagraph (A) are the Department of Health
and Human Services, the Department of
Homeland Security, the Department of Defense, and the Department of Veterans Affairs.
(3) Purpose of System
(A) In general
The Secretary may activate the National
Disaster Medical System to—
(i) provide health services, health-related social services, other appropriate
human services, and appropriate auxiliary
services to respond to the needs of victims
of a public health emergency (whether or
not determined to be a public health emergency under section 247d of this title); or
(ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has
determined that a location is at risk of a
public health emergency during the time
specified.
(B) Ongoing activities
The National Disaster Medical System
shall carry out such ongoing activities as
may be necessary to prepare for the provision of services described in subparagraph
(A) in the event that the Secretary activates
the National Disaster Medical System for
such purposes.
(C) Test for mobilization of System
During the one-year period beginning on
December 19, 2006, the Secretary shall conduct an exercise to test the capability and
timeliness of the National Disaster Medical
System to mobilize and otherwise respond
effectively to a bioterrorist attack or other
public health emergency that affects two or
more geographic locations concurrently.
Thereafter, the Secretary may periodically
conduct such exercises regarding the National Disaster Medical System as the Secretary determines to be appropriate.
(b) Modifications
(1) In general
Taking into account the findings from the
joint review described under paragraph (2), the
Secretary shall modify the policies of the National Disaster Medical System as necessary.

§ 300hh–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Joint review and medical surge capacity
strategic plan
Not later than 180 days after December 19,
2006, the Secretary, in coordination with the
Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the
National Disaster Medical System. Such review shall include an evaluation of medical
surge capacity, as described by section
300hh–2(a) of this title. As part of the National
Health Security Strategy under section
300hh–1 of this title, the Secretary shall update the findings from such review and further
modify the policies of the National Disaster
Medical System as necessary.
(3) Participation agreements for non-Federal
entities
In carrying out paragraph (1), the Secretary
shall establish criteria regarding the participation of States and private entities in the
National Disaster Medical System, including
criteria regarding agreements for such participation. The criteria shall include the following:
(A) Provisions relating to the custody and
use of Federal personal property by such entities, which may in the discretion of the
Secretary include authorizing the custody
and use of such property to respond to emergency situations for which the National Disaster Medical System has not been activated
by the Secretary pursuant to subsection
(a)(3)(A) of this section. Any such custody
and use of Federal personal property shall be
on a reimbursable basis.
(B) Provisions relating to circumstances in
which an individual or entity has agreements with both the National Disaster Medical System and another entity regarding the
provision of emergency services by the individual. Such provisions shall address the
issue of priorities among the agreements involved.
(c) Intermittent disaster-response personnel
(1) In general
For the purpose of assisting the National
Disaster Medical System in carrying out duties under this section, the Secretary may appoint individuals to serve as intermittent personnel of such System in accordance with applicable civil service laws and regulations.
(2) Liability
For purposes of section 233(a) of this title
and the remedies described in such section, an
individual appointed under paragraph (1) shall,
while acting within the scope of such appointment, be considered to be an employee of the
Public Health Service performing medical,
surgical, dental, or related functions. With respect to the participation of individuals appointed under paragraph (1) in training programs authorized by the Assistant Secretary
for Preparedness and Response or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this section, acts
of individuals so appointed that are within the
scope of such participation shall be considered

Page 1348

within the scope of the appointment under
paragraph (1) (regardless of whether the individuals receive compensation for such participation).
(d) Certain employment issues regarding intermittent appointments
(1) Intermittent disaster-response appointee
For purposes of this subsection, the term
‘‘intermittent disaster-response appointee’’
means an individual appointed by the Secretary under subsection (c) of this section.
(2) Compensation for work injuries
An intermittent disaster-response appointee
shall, while acting in the scope of such appointment, be considered to be an employee of
the Public Health Service performing medical,
surgical, dental, or related functions, and an
injury sustained by such an individual shall be
deemed ‘‘in the performance of duty’’, for purposes of chapter 81 of title 5 pertaining to
compensation for work injuries. With respect
to the participation of individuals appointed
under subsection (c) of this section in training
programs authorized by the Assistant Secretary for Preparedness and Response or a
comparable official of any Federal agency
specified in subsection (a)(2)(B) of this section,
injuries sustained by such an individual, while
acting within the scope of such participation,
also shall be deemed ‘‘in the performance of
duty’’ for purposes of chapter 81 of title 5 (regardless of whether the individuals receive
compensation for such participation). In the
event of an injury to such an intermittent disaster-response appointee, the Secretary of
Labor shall be responsible for making determinations as to whether the claimant is entitled to compensation or other benefits in accordance with chapter 81 of title 5.
(3) Employment and reemployment rights
(A) In general
Service as an intermittent disaster-response appointee when the Secretary activates the National Disaster Medical System
or when the individual participates in a
training program authorized by the Assistant Secretary for Preparedness and Response
or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this
section shall be deemed ‘‘service in the uniformed services’’ for purposes of chapter 43
of title 38 pertaining to employment and reemployment rights of individuals who have
performed service in the uniformed services
(regardless of whether the individual receives compensation for such participation).
All rights and obligations of such persons
and procedures for assistance, enforcement,
and investigation shall be as provided for in
chapter 43 of title 38.
(B) Notice of absence from position of employment
Preclusion of giving notice of service by
necessity of Service as an intermittent disaster-response appointee when the Secretary
activates the National Disaster Medical System shall be deemed preclusion by ‘‘military
necessity’’ for purposes of section 4312(b) of

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

title 38 pertaining to giving notice of absence from a position of employment. A determination of such necessity shall be made
by the Secretary, in consultation with the
Secretary of Defense, and shall not be subject to judicial review.
(4) Limitation
An intermittent disaster-response appointee
shall not be deemed an employee of the Department of Health and Human Services for
purposes other than those specifically set
forth in this section.
(e) Rule of construction regarding use of commissioned corps
If the Secretary assigns commissioned officers
of the Regular or Reserve Corps to serve with
the National Disaster Medical System, such assignments do not affect the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps, respectively (including with respect to pay and allowances, retirement, benefits, rights, privileges,
and immunities).
(f) Definition
For purposes of this section, the term ‘‘auxiliary services’’ includes mortuary services, veterinary services, and other services that are determined by the Secretary to be appropriate
with respect to the needs referred to in subsection (a)(3)(A) of this section.
(g) Authorization of appropriations
For the purpose of providing for the Assistant
Secretary for Preparedness and Response and
the operations of the National Disaster Medical
System, other than purposes for which amounts
in the Public Health Emergency Fund under section 247d of this title are available, there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2007
through 2011.
(July 1, 1944, ch. 373, title XXVIII, § 2812, formerly § 2811, as added Pub. L. 107–188, title I,
§ 102(a), June 12, 2002, 116 Stat. 599; renumbered
§ 2812 and amended Pub. L. 109–417, title I,
§ 102(a)(2), (4), title III, § 301(a), Dec. 19, 2006, 120
Stat. 2832, 2834, 2853.)
AMENDMENTS
2006—Pub. L. 109–417, § 301(a)(1), substituted ‘‘National
Disaster Medical System’’ for ‘‘Coordination of preparedness for and response to bioterrorism and other
public health emergencies’’ in section catchline.
Subsec. (a). Pub. L. 109–417, § 301(a)(2), (3), redesignated subsec. (b) as (a) and struck out former subsec.
(a) which related to establishment of position and duties of Assistant Secretary for Public Health Emergency Preparedness.
Subsec. (a)(2)(B). Pub. L. 109–417, § 301(a)(4)(A), substituted ‘‘Department of Homeland Security’’ for ‘‘Federal Emergency Management Agency’’.
Subsec. (a)(3)(C). Pub. L. 109–417, § 301(a)(4)(B), substituted ‘‘December 19, 2006’’ for ‘‘June 12, 2002’’.
Subsec. (b). Pub. L. 109–417, § 301(a)(5), substituted
‘‘Modifications’’ for ‘‘Criteria’’ in heading, added pars.
(1) and (2), redesignated former par. (2) as (3), and
struck out heading and text of former par. (1). Text
read as follows: ‘‘The Secretary shall establish criteria
for the operation of the National Disaster Medical System.’’
Pub. L. 109–417, § 301(a)(3), redesignated subsec. (c) as
(b). Former subsec. (b) redesignated (a).

§ 300hh–12

Subsec. (b)(1). Pub. L. 109–417, § 102(a)(4), substituted
‘‘Assistant Secretary for Preparedness and Response’’
for ‘‘Assistant Secretary for Public Health Emergency
Preparedness’’.
Subsec. (b)(3)(A). Pub. L. 109–417, § 301(a)(6), substituted
‘‘subsection
(a)(3)(A)’’
for
‘‘subsection
(b)(3)(A)’’.
Subsec. (c). Pub. L. 109–417, § 301(a)(3), redesignated
subsec. (d) as (c). Former subsec. (c) redesignated (b).
Subsec. (c)(2). Pub. L. 109–417, § 301(a)(6), substituted
‘‘subsection (a)(2)(B)’’ for ‘‘subsection (b)(2)(B)’’.
Subsec. (d). Pub. L. 109–417, § 301(a)(7), substituted
‘‘subsection (c)’’ for ‘‘subsection (d)’’ in pars. (1) and (2).
Pub. L. 109–417, § 301(a)(6), substituted ‘‘subsection
(a)(2)(B)’’ for ‘‘subsection (b)(2)(B)’’ in pars. (2) and
(3)(A).
Pub. L. 109–417, § 301(a)(3), redesignated subsec. (e) as
(d). Former subsec. (d) redesignated (c).
Subsec. (d)(2). Pub. L. 109–417, § 102(a)(4), substituted
‘‘Assistant Secretary for Preparedness and Response’’
for ‘‘Assistant Secretary for Public Health Emergency
Preparedness’’.
Subsec. (e). Pub. L. 109–417, § 301(a)(3), redesignated
subsec. (f) as (e). Former subsec. (e) redesignated (d).
Subsec. (e)(2), (3)(A). Pub. L. 109–417, § 102(a)(4), substituted ‘‘Assistant Secretary for Preparedness and Response’’ for ‘‘Assistant Secretary for Public Health
Emergency Preparedness’’.
Subsec. (f). Pub. L. 109–417, § 301(a)(6), substituted
‘‘subsection (a)(3)(A)’’ for ‘‘subsection (b)(3)(A)’’.
Pub. L. 109–417, § 301(a)(3), redesignated subsec. (g) as
(f). Former subsec. (f) redesignated (e).
Subsec. (g). Pub. L. 109–417, § 301(a)(8), substituted
‘‘2007 through 2011’’ for ‘‘2002 through 2006’’.
Pub. L. 109–417, § 301(a)(3), redesignated subsec. (h) as
(g). Former subsec. (g) redesignated (f).
Subsec. (h). Pub. L. 109–417, § 301(a)(3), redesignated
subsec. (h) as (g).
Pub. L. 109–417, § 102(a)(4), substituted ‘‘Assistant Secretary for Preparedness and Response’’ for ‘‘Assistant
Secretary for Public Health Emergency Preparedness’’.
TRANSFER OF FUNCTIONS
Pub. L. 109–417, title III, § 301(b), Dec. 19, 2006, 120
Stat. 2854, provided that: ‘‘There shall be transferred to
the Secretary of Health and Human Services the functions, personnel, assets, and liabilities of the National
Disaster Medical System of the Department of Homeland Security, including the functions of the Secretary
of Homeland Security and the Under Secretary for
Emergency Preparedness and Response relating thereto.’’
Pub. L. 109–295, title III, Oct. 4, 2006, 120 Stat. 1372,
provided in part: ‘‘That the total amount appropriated
and, notwithstanding any other provision of law, the
functions, personnel, assets, and liabilities of the National Disaster Medical System established under section 2811(b) [now 2812(a)] of the Public Health Service
Act (42 U.S.C. 300hh–11(b) [now 300hh–11(a)]), including
any functions of the Secretary of Homeland Security
relating to such System, shall be permanently transferred to the Secretary of the Department of Health
and Human Services effective January 1, 2007.’’
For transfer of functions, personnel, assets, and liabilities of the National Disaster Medical System of
the Department of Health and Human Services, including the functions of the Secretary of Health and Human
Services and the Assistant Secretary for Public Health
Emergency Preparedness (now Assistant Secretary for
Preparedness and Response) relating thereto, to the
Secretary of Homeland Security, and for treatment of
related references, see former section 313(5) and sections 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set
out as a note under section 542 of Title 6.

§ 300hh–12. Transferred
CODIFICATION
Section, Pub. L. 107–188, title I, § 121, June 12, 2002, 116
Stat. 611, as amended, which related to Strategic Na-

§ 300hh–13

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tional Stockpile, was renumbered section 319F–2 of the
Public Health Service Act by Pub. L. 108–276, § 3(a)(1),
July 21, 2004, 118 Stat. 842 and is classified to section
247d–6b of this title.

§ 300hh–13. Evaluation of new and emerging
technologies regarding bioterrorist attack
and other public health emergencies
(a) In general
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’)
shall promptly carry out a program to periodically evaluate new and emerging technologies
that, in the determination of the Secretary, are
designed to improve or enhance the ability of
public health or safety officials to conduct public health surveillance activities relating to a
bioterrorist attack or other public health emergency.
(b) Certain activities
In carrying out this subsection, the Secretary
shall, to the extent practicable—
(1) survey existing technology programs
funded by the Federal Government for potentially useful technologies;
(2) promptly issue a request, as necessary,
for information from non-Federal public and
private entities for ongoing activities in this
area; and
(3) evaluate technologies identified under
paragraphs (1) and (2) pursuant to subsection
(c) of this section.
(c) Consultation and evaluation
In carrying out subsection (b)(3) of this section, the Secretary shall consult with the working group under section 247d–6(a) 1 of this title,
as well as other appropriate public, nonprofit,
and private entities, to develop criteria for the
evaluation of such technologies and to conduct
such evaluations.
(d) Report
Not later than 180 days after June 12, 2002, and
periodically thereafter, the Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the activities
under this section.
(Pub. L. 107–188, title I, § 126, June 12, 2002, 116
Stat. 615.)
REFERENCES IN TEXT
Section 247d–6 of this title, referred to in subsec. (c),
was amended by Pub. L. 109–417, title III, § 304, Dec. 19,
2006, 120 Stat. 2859, and as so amended, subsec. (a) of
section 247d–6 no longer relates to a working group.
CODIFICATION
Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, and not as part of the Public Health Service
Act which comprises this chapter.

§ 300hh–14. Protection of health and safety during disasters
(a) Definitions
In this section:
1 See

References in Text note below.

Page 1350

(1) Certified monitoring program
The term ‘‘certified monitoring program’’
means a medical monitoring program—
(A) in which a participating responder is a
participant as a condition of the employment of such participating responder; and
(B) that the Secretary of Health and
Human Services certifies includes an adequate baseline medical screening.
(2) Disaster area
The term ‘‘disaster area’’ means an area in
which the President has declared a major disaster (as that term is defined in section 5122 of
this title), during the period of such declaration.
(3) High exposure level
The term ‘‘high exposure level’’ means a
level of exposure to a substance of concern
that is for such a duration, or of such a magnitude, that adverse effects on human health
can be reasonably expected to occur, as determined by the President, acting through the
Secretary of Health and Human Services, in
accordance with human monitoring or environmental or other appropriate indicators.
(4) Individual
The term ‘‘individual’’ includes—
(A) a worker or volunteer who responds to
a disaster, either natural or manmade, involving any mode of transportation in the
United States or disrupting the transportation system of the United States, including—
(i) a police officer;
(ii) a firefighter;
(iii) an emergency medical technician;
(iv) any participating member of an
urban search and rescue team; and
(v) any other relief or rescue worker or
volunteer that the President, acting
through the Secretary of Health and
Human Services, determines to be appropriate;
(B) a worker who responds to a disaster, either natural or manmade, involving any
mode of transportation in the United States
or disrupting the transportation system of
the United States, by assisting in the cleanup or restoration of critical infrastructure
in and around a disaster area;
(C) a person whose place of residence is in
a disaster area, caused by either a natural or
manmade disaster involving any mode of
transportation in the United States or disrupting the transportation system of the
United States;
(D) a person who is employed in or attends
school, child care, or adult day care in a
building located in a disaster area, caused by
either a natural or manmade disaster involving any mode of transportation in the
United States or disrupting the transportation system of the United States, of the
United States; and
(E) any other person that the President,
acting through the Secretary of Health and
Human Services, determines to be appropriate.

Page 1351

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) Participating responder
The term ‘‘participating responder’’ means
an individual described in paragraph (4)(A).
(6) Program
The term ‘‘program’’ means a program described in subsection (b) that is carried out for
a disaster area.
(7) Substance of concern
The term ‘‘substance of concern’’ means a
chemical or other substance that is associated
with potential acute or chronic human health
effects, the risk of exposure to which could potentially be increased as the result of a disaster, as determined by the President, acting
through the Secretary of Health and Human
Services, and in coordination with the Agency
for Toxic Substances and Disease Registry,
the Environmental Protection Agency, the
Centers for Disease Control and Prevention,
the National Institutes of Health, the Federal
Emergency Management Agency, the Occupational Health and Safety Administration, and
other agencies.
(b) Program
(1) In general
If the President, acting through the Secretary of Health and Human Services, determines that 1 or more substances of concern are
being, or have been, released in an area declared to be a disaster area and disrupts the
transportation system of the United States,
the President, acting through the Secretary of
Health and Human Services, may carry out a
program for the coordination, protection, assessment, monitoring, and study of the health
and safety of individuals with high exposure
levels to ensure that—
(A) the individuals are adequately informed about and protected against potential health impacts of any substance of concern in a timely manner;
(B) the individuals are monitored and
studied over time, including through baseline and followup clinical health examinations, for—
(i) any short- and long-term health impacts of any substance of concern; and
(ii) any mental health impacts;
(C) the individuals receive health care referrals as needed and appropriate; and
(D) information from any such monitoring
and studies is used to prevent or protect
against similar health impacts from future
disasters.
(2) Activities
A program under paragraph (1) may include
such activities as—
(A) collecting and analyzing environmental exposure data;
(B) developing and disseminating information and educational materials;
(C) performing baseline and followup clinical health and mental health examinations
and taking biological samples;
(D) establishing and maintaining an exposure registry;
(E) studying the short- and long-term
human health impacts of any exposures

§ 300hh–14

through epidemiological and other health
studies; and
(F) providing assistance to individuals in
determining eligibility for health coverage
and identifying appropriate health services.
(3) Timing
To the maximum extent practicable, activities under any program carried out under
paragraph (1) (including baseline health examinations) shall be commenced in a timely
manner that will ensure the highest level of
public health protection and effective monitoring.
(4) Participation in registries and studies
(A) In general
Participation in any registry or study that
is part of a program carried out under paragraph (1) shall be voluntary.
(B) Protection of privacy
The President, acting through the Secretary of Health and Human Services, shall
take appropriate measures to protect the
privacy of any participant in a registry or
study described in subparagraph (A).
(C) Priority
(i) In general
Except as provided in clause (ii), the
President, acting through the Secretary of
Health and Human Services, shall give priority in any registry or study described in
subparagraph (A) to the protection, monitoring and study of the health and safety
of individuals with the highest level of exposure to a substance of concern.
(ii) Modifications
Notwithstanding clause (i), the President, acting through the Secretary of
Health and Human Services, may modify
the priority of a registry or study described in subparagraph (A), if the President, acting through the Secretary of
Health and Human Services, determines
such modification to be appropriate.
(5) Cooperative agreements
(A) In general
The President, acting through the Secretary of Health and Human Services, may
carry out a program under paragraph (1)
through a cooperative agreement with a
medical institution, including a local health
department, or a consortium of medical institutions.
(B) Selection criteria
To the maximum extent practicable, the
President, acting through the Secretary of
Health and Human Services, shall select, to
carry out a program under paragraph (1), a
medical institution or a consortium of medical institutions that—
(i) is located near—
(I) the disaster area with respect to
which the program is carried out; and
(II) any other area in which there reside groups of individuals that worked or
volunteered in response to the disaster;
and

§ 300hh–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) has appropriate experience in the
areas of environmental or occupational
health, toxicology, and safety, including
experience in—
(I) developing clinical protocols and
conducting clinical health examinations,
including mental health assessments;
(II) conducting long-term health monitoring and epidemiological studies;
(III) conducting long-term mental
health studies; and
(IV) establishing and maintaining medical surveillance programs and environmental exposure or disease registries.
(6) Involvement
(A) In general
In carrying out a program under paragraph
(1), the President, acting through the Secretary of Health and Human Services, shall
involve interested and affected parties, as
appropriate, including representatives of—
(i) Federal, State, and local government
agencies;
(ii) groups of individuals that worked or
volunteered in response to the disaster in
the disaster area;
(iii) local residents, businesses, and
schools (including parents and teachers);
(iv) health care providers;
(v) faith based organizations; and
(vi) other organizations and persons.
(B) Committees
Involvement under subparagraph (A) may
be provided through the establishment of an
advisory or oversight committee or board.
(7) Privacy
The President, acting through the Secretary
of Health and Human Services, shall carry out
each program under paragraph (1) in accordance with regulations relating to privacy promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d–2 note; Public Law
104–191).
(8) Existing programs
In carrying out a program under paragraph
(1), the President, acting through the Secretary of Health and Human Services, may—
(A) include the baseline clinical health examination of a participating responder
under a certified monitoring programs; 1 and
(B) substitute the baseline clinical health
examination of a participating responder
under a certified monitoring program for a
baseline clinical health examination under
paragraph (1).
(c) Reports
Not later than 1 year after the establishment
of a program under subsection (b)(1), and every
5 years thereafter, the President, acting through
the Secretary of Health and Human Services, or
the medical institution or consortium of such
institutions having entered into a cooperative
agreement under subsection (b)(5), may submit a
report to the Secretary of Homeland Security,
1 So

in original. Probably should be ‘‘program;’’.

Page 1352

the Secretary of Labor, the Administrator of the
Environmental Protection Agency, and appropriate committees of Congress describing the
programs and studies carried out under the program.
(d) National Academy of Sciences report on disaster area health and environmental protection and monitoring
(1) In general
The Secretary of Health and Human Services, the Secretary of Homeland Security, and
the Administrator of the Environmental Protection Agency shall jointly enter into a contract with the National Academy of Sciences
to conduct a study and prepare a report on disaster area health and environmental protection and monitoring.
(2) Participation of experts
The report under paragraph (1) shall be prepared with the participation of individuals
who have expertise in—
(A) environmental health, safety, and medicine;
(B) occupational health, safety, and medicine;
(C) clinical medicine, including pediatrics;
(D) environmental toxicology;
(E) epidemiology;
(F) mental health;
(G) medical monitoring and surveillance;
(H) environmental monitoring and surveillance;
(I) environmental and industrial hygiene;
(J) emergency planning and preparedness;
(K) public outreach and education;
(L) State and local health departments;
(M) State and local environmental protection departments;
(N) functions of workers that respond to
disasters, including first responders;
(O) public health; and
(P) family services, such as counseling and
other disaster-related services provided to
families.
(3) Contents
The report under paragraph (1) shall provide
advice and recommendations regarding protecting and monitoring the health and safety
of individuals potentially exposed to any
chemical or other substance associated with
potential acute or chronic human health effects as the result of a disaster, including advice and recommendations regarding—
(A) the establishment of protocols for
monitoring and responding to chemical or
substance releases in a disaster area to protect public health and safety, including—
(i) chemicals or other substances for
which samples should be collected in the
event of a disaster, including a terrorist
attack;
(ii) chemical- or substance-specific
methods of sample collection, including
sampling methodologies and locations;
(iii) chemical- or substance-specific
methods of sample analysis;
(iv) health-based threshold levels to be
used and response actions to be taken in
the event that thresholds are exceeded for
individual chemicals or other substances;

Page 1353

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(v) procedures for providing monitoring
results to—
(I) appropriate Federal, State, and
local government agencies;
(II) appropriate response personnel;
and
(III) the public;
(vi) responsibilities of Federal, State,
and local agencies for—
(I) collecting and analyzing samples;
(II) reporting results; and
(III) taking appropriate response actions; and
(vii) capabilities and capacity within the
Federal Government to conduct appropriate environmental monitoring and response in the event of a disaster, including
a terrorist attack; and
(B) other issues specified by the Secretary
of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Environmental Protection Agency.
(4) Authorization of appropriations
There are authorized to be appropriated such
sums as are necessary to carry out this subsection.
(Pub. L. 109–347, title VII, § 709, Oct. 13, 2006, 120
Stat. 1947.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec. (b)(7),
is section 264(c) of Pub. L. 104–191, which is set out as
a note under section 1320d–2 of this title.
CODIFICATION
Section was enacted as part of the Security and Accountability For Every Port Act of 2006, also known as
the SAFE Port Act, and not as part of the Public
Health Service Act which comprises this chapter.

§ 300hh–15. Volunteer Medical Reserve Corps
(a) In general
Not later than 180 days after December 19,
2006, the Secretary, in collaboration with State,
local, and tribal officials, shall build on State,
local, and tribal programs in existence on December 19, 2006, to establish and maintain a
Medical Reserve Corps (referred to in this section as the ‘‘Corps’’) to provide for an adequate
supply of volunteers in the case of a Federal,
State, local, or tribal public health emergency.
The Corps shall be headed by a Director who
shall be appointed by the Secretary and shall
oversee the activities of the Corps chapters that
exist at the State, local, and tribal levels.
(b) State, local, and tribal coordination
The Corps shall be established using existing
State, local, and tribal teams and shall not alter
such teams.
(c) Composition
The Corps shall be composed of individuals
who—
(1)(A) are health professionals who have appropriate professional training and expertise
as determined appropriate by the Director of
the Corps; or

§ 300hh–15

(B) are non-health professionals who have an
interest in serving in an auxiliary or support
capacity to facilitate access to health care
services in a public health emergency;
(2) are certified in accordance with the certification program developed under subsection
(d);
(3) are geographically diverse in residence;
(4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
(5) indicate whether they are willing to be
deployed outside the area in which they reside
in the event of a public health emergency.
(d) Certification; drills
(1) Certification
The Director, in collaboration with State,
local, and tribal officials, shall establish a
process for the periodic certification of individuals who volunteer for the Corps, as determined by the Secretary, which shall include
the completion by each individual of the core
training programs developed under section
247d–6 of this title, as required by the Director.
Such certification shall not supercede State licensing or credentialing requirements.
(2) Drills
In conjunction with the core training programs referred to in paragraph (1), and in
order to facilitate the integration of trained
volunteers into the health care system at the
local level, Corps members shall engage in
periodic training exercises to be carried out at
the local level.
(e) Deployment
During a public health emergency, the Secretary shall have the authority to activate and
deploy willing members of the Corps to areas of
need, taking into consideration the public
health and medical expertise required, with the
concurrence of the State, local, or tribal officials from the area where the members reside.
(f) Expenses and transportation
While engaged in performing duties as a member of the Corps pursuant to an assignment by
the Secretary (including periods of travel to facilitate such assignment), members of the Corps
who are not otherwise employed by the Federal
Government shall be allowed travel or transportation expenses, including per diem in lieu of
subsistence.
(g) Identification
The Secretary, in cooperation and consultation with the States, shall develop a Medical Reserve Corps Identification Card that describes
the licensure and certification information of
Corps members, as well as other identifying information determined necessary by the Secretary.
(h) Intermittent disaster-response personnel
(1) In general
For the purpose of assisting the Corps in carrying out duties under this section, during a
public health emergency, the Secretary may
appoint selected individuals to serve as intermittent personnel of such Corps in accordance

§ 300hh–16

TITLE 42—THE PUBLIC HEALTH AND WELFARE

with applicable civil service laws and regulations. In all other cases, members of the Corps
are subject to the laws of the State in which
the activities of the Corps are undertaken.
(2) Applicable protections
Subsections (c)(2), (d), and (e) of section
300hh–11 of this title shall apply to an individual appointed under paragraph (1) in the same
manner as such subsections apply to an individual appointed under section 300hh–11(c) of
this title.
(3) Limitation
State, local, and tribal officials shall have
no authority to designate a member of the
Corps as Federal intermittent disaster-response personnel, but may request the services
of such members.
(i) Authorization of appropriations
There is authorized to be appropriated to
carry out this section, $22,000,000 for fiscal year
2007, and such sums as may be necessary for
each of fiscal years 2008 through 2011.
(July 1, 1944, ch. 373, title XXVIII, § 2813, as
added Pub. L. 109–417, title III, § 303(a), Dec. 19,
2006, 120 Stat. 2856.)
§ 300hh–16. At-risk individuals
The Secretary, acting through such employee
of the Department of Health and Human Services as determined by the Secretary and designated publicly (which may, at the discretion
of the Secretary, involve the appointment or
designation of an individual as the Director of
At-Risk Individuals), shall—
(1) oversee the implementation of the National Preparedness goal of taking into account the public health and medical needs of
at-risk individuals in the event of a public
health emergency, as described in section
300hh–1(b)(4) of this title;
(2) assist other Federal agencies responsible
for planning for, responding to, and recovering
from public health emergencies in addressing
the needs of at-risk individuals;
(3) provide guidance to and ensure that recipients of State and local public health
grants include preparedness and response
strategies and capabilities that take into account the medical and public health needs of
at-risk individuals in the event of a public
health emergency, as described in section
247d–3a(b)(2)(A)(iii) of this title;
(4) ensure that the contents of the strategic
national stockpile take into account at-risk
populations
as
described
in
section
300hh–10(b)(3)(B) 1 of this title;
(5) oversee the progress of the Advisory
Committee on At-Risk Individuals and Public
Health Emergencies established under section
247d–6(b)(2) of this title and make recommendations with a focus on opportunities for
action based on the work of the Committee;
(6) oversee curriculum development for the
public health and medical response training
program on medical management of casual1 So in original. Section 300hh–10(b)(3) of this title does not
contain subpars.

Page 1354

ties, as it concerns at-risk individuals as described in subparagraphs (A) through (C) of
section 247d–6(a)(2) of this title;
(7) disseminate novel and best practices of
outreach to and care of at-risk individuals before, during, and following public health emergencies; and
(8) not later than one year after December
19, 2006, prepare and submit to Congress a report describing the progress made on implementing the duties described in this section.
(July 1, 1944, ch. 373, title XXVIII, § 2814, as
added Pub. L. 109–417, title I, § 102(d), Dec. 19,
2006, 120 Stat. 2834.)
§ 300hh–17. Emergency response coordination of
primary care providers
The Secretary, acting through Administrator 1
of the Health Resources and Services Administration, and in coordination with the Assistant
Secretary for Preparedness and Response, shall
(1) provide guidance and technical assistance
to health centers funded under section 254b of
this title and to State and local health departments and emergency managers to integrate
health centers into State and local emergency
response plans and to better meet the primary
care needs of populations served by health
centers during public health emergencies; and
(2) encourage employees at health centers
funded under section 254b of this title to participate in emergency medical response programs including the National Disaster Medical
System authorized in section 300hh–11 of this
title, the Volunteer Medical Reserve Corps authorized in section 300hh–15 of this title, and
the Emergency System for Advance Registration of Health Professions Volunteers authorized in section 247d–7b of this title.
(July 1, 1944, ch. 373, title XXVIII, § 2815, as
added Pub. L. 110–355, § 6(a), Oct. 8, 2008, 122 Stat.
3994.)
PART C—STRENGTHENING PUBLIC HEALTH
SURVEILLANCE SYSTEMS
§ 300hh–31.
grants

Epidemiology-laboratory

capacity

(a) In general
Subject to the availability of appropriations,
the Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall establish an Epidemiology and Laboratory
Capacity Grant Program to award grants to
State health departments as well as local health
departments and tribal jurisdictions that meet
such criteria as the Director determines appropriate. Academic centers that assist State and
eligible local and tribal health departments may
also be eligible for funding under this section as
the Director determines appropriate. Grants
shall be awarded under this section to assist
public health agencies in improving surveillance
for, and response to, infectious diseases and
other conditions of public health importance
by—
(1) strengthening epidemiologic capacity to
identify and monitor the occurrence of infec1 So

in original. Probably should be preceded by ‘‘the’’.

Page 1355

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tious diseases and other conditions of public
health importance;
(2) enhancing laboratory practice as well as
systems to report test orders and results electronically;
(3) improving information systems including
developing and maintaining an information
exchange using national guidelines and complying with capacities and functions determined by an advisory council established and
appointed by the Director; and
(4) developing and implementing prevention
and control strategies.
(b) Authorization of appropriations
There are authorized to be appropriated to
carry out this section $190,000,000 for each of fiscal years 2010 through 2013, of which—
(1) not less than $95,000,000 shall be made
available each such fiscal year for activities
under paragraphs (1) and (4) of subsection (a);
(2) not less than $60,000,000 shall be made
available each such fiscal year for activities
under subsection (a)(3); and
(3) not less than $32,000,000 shall be made
available each such fiscal year for activities
under subsection (a)(2).
(July 1, 1944, ch. 373, title XXVIII, § 2821, as
added Pub. L. 111–148, title IV, § 4304, Mar. 23,
2010, 124 Stat. 584.)
SUBCHAPTER XXVII—LIFESPAN RESPITE
CARE
§ 300ii. Definitions
In this subchapter:
(1) Adult with a special need
The term ‘‘adult with a special need’’ means
a person 18 years of age or older who requires
care or supervision to—
(A) meet the person’s basic needs;
(B) prevent physical self-injury or injury
to others; or
(C) avoid placement in an institutional facility.
(2) Aging and disability resource center
The term ‘‘aging and disability resource center’’ means an entity administering a program
established by the State, as part of the State’s
system of long-term care, to provide a coordinated system for providing—
(A) comprehensive information on available public and private long-term care programs, options, and resources;
(B) personal counseling to assist individuals in assessing their existing or anticipated long-term care needs, and developing
and implementing a plan for long-term care
designed to meet their specific needs and circumstances; and
(C) consumer access to the range of publicly supported long-term care programs for
which consumers may be eligible, by serving
as a convenient point of entry for such programs.
(3) Child with a special need
The term ‘‘child with a special need’’ means
an individual less than 18 years of age who requires care or supervision beyond that required of children generally to—

§ 300ii

(A) meet the child’s basic needs; or
(B) prevent physical injury, self-injury, or
injury to others.
(4) Eligible State agency
The term ‘‘eligible State agency’’ means a
State agency that—
(A) administers the State’s program under
the Older Americans Act of 1965 [42 U.S.C.
3001 et seq.], administers the State’s program under title XIX of the Social Security
Act [42 U.S.C. 1396 et seq.], or is designated
by the Governor of such State to administer
the State’s programs under this subchapter;
(B) is an aging and disability resource center;
(C) works in collaboration with a public or
private nonprofit statewide respite care coalition or organization; and
(D) demonstrates—
(i) an ability to work with other State
and community-based agencies;
(ii) an understanding of respite care and
family caregiver issues across all age
groups, disabilities, and chronic conditions; and
(iii) the capacity to ensure meaningful
involvement of family members, family
caregivers, and care recipients.
(5) Family caregiver
The term ‘‘family caregiver’’ means an unpaid family member, a foster parent, or another unpaid adult, who provides in-home
monitoring, management, supervision, or
treatment of a child or adult with a special
need.
(6) Lifespan respite care
The term ‘‘lifespan respite care’’ means a
coordinated system of accessible, communitybased respite care services for family caregivers of children or adults with special needs.
(7) Respite care
The term ‘‘respite care’’ means planned or
emergency care provided to a child or adult
with a special need in order to provide temporary relief to the family caregiver of that
child or adult.
(8) State
The term ‘‘State’’ means any of the several
States, the District of Columbia, the Virgin Islands of the United States, the Commonwealth
of Puerto Rico, Guam, American Samoa, and
the Commonwealth of the Northern Mariana
Islands.
(July 1, 1944, ch. 373, title XXIX, § 2901, as added
Pub. L. 109–442, § 2, Dec. 21, 2006, 120 Stat. 3291.)
REFERENCES IN TEXT
The Older Americans Act of 1965, referred to in par.
(4)(A), is Pub. L. 89–73, July 14, 1965, 79 Stat. 218, which
is classified generally to chapter 35 (§ 3001 et seq.) of
this title. For complete classification of this Act to the
Code, see Short Title note set out under section 3001 of
this title and Tables.
The Social Security Act, referred to in par. (4)(A), is
act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XIX of the
Act is classified generally to subchapter XIX (§ 1396 et
seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.

§ 300ii–1

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300ii–1. Lifespan respite care grants and cooperative agreements
(a) Purposes
The purposes of this section are—
(1) to expand and enhance respite care services to family caregivers;
(2) to improve the statewide dissemination
and coordination of respite care; and
(3) to provide, supplement, or improve access
and quality of respite care services to family
caregivers, thereby reducing family caregiver
strain.
(b) Authorization
Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for the purposes described in subsection
(a) to eligible State agencies for which an application is submitted pursuant to subsection (d).
(c) Federal lifespan approach
In carrying out this section, the Secretary
shall work in cooperation with the National
Family Caregiver Support Program of the Administration on Aging and other respite care
programs within the Department of Health and
Human Services to ensure coordination of respite care services for family caregivers of children and adults with special needs.
(d) Application
(1) Submission
Each Governor desiring the eligible State
agency of his or her State to receive a grant or
cooperative agreement under this section shall
submit an application on behalf of such agency to the Secretary at such time, in such manner, and containing such information as the
Secretary shall require.
(2) Contents
Each application submitted under this section shall include—
(A) a description of the eligible State
agency’s—
(i) ability to work with other State and
community-based agencies;
(ii) understanding of respite care and
family caregiver issues across all age
groups, disabilities, and chronic conditions; and
(iii) capacity to ensure meaningful involvement of family members, family
caregivers, and care recipients;
(B) with respect to the population of family caregivers to whom respite care information or services will be provided or for whom
respite care workers and volunteers will be
recruited and trained, a description of—
(i) the population of family caregivers;
(ii) the extent and nature of the respite
care needs of that population;
(iii) existing respite care services for
that population, including numbers of
family caregivers being served and extent
of unmet need;
(iv) existing methods or systems to coordinate respite care information and services to the population at the State and
local level and extent of unmet need;
(v) how respite care information dissemination and coordination, respite care serv-

Page 1356

ices, respite care worker and volunteer recruitment and training programs, or training programs for family caregivers that assist such family caregivers in making informed decisions about respite care services will be provided using grant or cooperative agreement funds;
(vi) a plan for administration, collaboration, and coordination of the proposed respite care activities with other related
services or programs offered by public or
private, nonprofit entities, including area
agencies on aging;
(vii) how the population, including family caregivers, care recipients, and relevant public or private agencies, will participate in the planning and implementation of the proposed respite care activities;
(viii) how the proposed respite care activities will make use, to the maximum
extent feasible, of other Federal, State,
and local funds, programs, contributions,
other forms of reimbursements, personnel,
and facilities;
(ix) respite care services available to
family caregivers in the eligible State
agency’s State or locality, including
unmet needs and how the eligible State
agency’s plan for use of funds will improve
the coordination and distribution of respite care services for family caregivers of
children and adults with special needs;
(x) the criteria used to identify family
caregivers eligible for respite care services;
(xi) how the quality and safety of any
respite care services provided will be monitored, including methods to ensure that
respite care workers and volunteers are
appropriately screened and possess the
necessary skills to care for the needs of
the care recipient in the absence of the
family caregiver; and
(xii) the results expected from proposed
respite care activities and the procedures
to be used for evaluating those results;
(C) assurances that, where appropriate, the
eligible State agency will have a system for
maintaining the confidentiality of care recipient and family caregiver records; and
(D) a memorandum of agreement regarding
the joint responsibility for the eligible State
agency’s lifespan respite program between—
(i) the eligible State agency; and
(ii) a public or private nonprofit statewide respite coalition or organization.
(e) Priority; considerations
When awarding grants or cooperative agreements under this section, the Secretary shall—
(1) give priority to eligible State agencies
that the Secretary determines show the greatest likelihood of implementing or enhancing
lifespan respite care statewide; and
(2) give consideration to eligible State agencies that are building or enhancing the capacity of their long-term care systems to respond
to the comprehensive needs, including respite
care needs, of their residents.

Page 1357

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Use of grant or cooperative agreement funds
(1) In general
(A) Required uses of funds
Each eligible State agency awarded a
grant or cooperative agreement under this
section shall use all or part of the funds—
(i) to develop or enhance lifespan respite
care at the State and local levels;
(ii) to provide respite care services for
family caregivers caring for children or
adults;
(iii) to train and recruit respite care
workers and volunteers;
(iv) to provide information to caregivers
about available respite and support services; and
(v) to assist caregivers in gaining access
to such services.
(B) Optional uses of funds
Each eligible State agency awarded a
grant or cooperative agreement under this
section may use part of the funds for—
(i) training programs for family caregivers to assist such family caregivers in
making informed decisions about respite
care services;
(ii) other services essential to the provision of respite care as the Secretary may
specify; or
(iii) training and education for new caregivers.
(2) Subcontracts
Each eligible State agency awarded a grant
or cooperative agreement under this section
may carry out the activities described in paragraph (1) directly or by grant to, or contract
with, public or private entities.
(3) Matching funds
(A) In general
With respect to the costs of the activities
to be carried out under paragraph (1), a condition for the receipt of a grant or cooperative agreement under this section is that the
eligible State agency agrees to make available (directly or through donations from
public or private entities) non-Federal contributions toward such costs in an amount
that is not less than 25 percent of such costs.
(B) Determination of amount contributed
Non-Federal contributions required by
subparagraph (A) may be in cash or in kind,
fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal
contributions.
(g) Term of grants or cooperative agreements
(1) In general
The Secretary shall award grants or cooperative agreements under this section for terms
that do not exceed 5 years.
(2) Renewal
The Secretary may renew a grant or cooperative agreement under this section at the end

§ 300jj

of the term of the grant or cooperative agreement determined under paragraph (1).
(h) Maintenance of effort
Funds made available under this section shall
be used to supplement and not supplant other
Federal, State, and local funds available for respite care services.
(July 1, 1944, ch. 373, title XXIX, § 2902, as added
Pub. L. 109–442, § 2, Dec. 21, 2006, 120 Stat. 3292.)
§ 300ii–2. National lifespan respite resource center
(a) Establishment
The Secretary may award a grant or cooperative agreement to a public or private nonprofit
entity to establish a National Resource Center
on Lifespan Respite Care (referred to in this section as the ‘‘center’’).
(b) Purposes of the center
The center shall—
(1) maintain a national database on lifespan
respite care;
(2) provide training and technical assistance
to State, community, and nonprofit respite
care programs; and
(3) provide information, referral, and educational programs to the public on lifespan
respite care.
(July 1, 1944, ch. 373, title XXIX, § 2903, as added
Pub. L. 109–442, § 2, Dec. 21, 2006, 120 Stat. 3295.)
§ 300ii–3. Report
Not later than January 1, 2009, the Secretary
shall report to the Congress on the activities
undertaken under this subchapter. Such report
shall evaluate—
(1) the number of States that have lifespan
respite care programs;
(2) the demographics of the caregivers receiving respite care services through grants or
cooperative agreements under this subchapter;
and
(3) the effectiveness of entities receiving
grants or cooperative agreements under this
subchapter.
(July 1, 1944, ch. 373, title XXIX, § 2904, as added
Pub. L. 109–442, § 2, Dec. 21, 2006, 120 Stat. 3295.)
§ 300ii–4. Authorization of appropriations
There are authorized to be appropriated to
carry out this subchapter—
(1) $30,000,000 for fiscal year 2007;
(2) $40,000,000 for fiscal year 2008;
(3) $53,330,000 for fiscal year 2009;
(4) $71,110,000 for fiscal year 2010; and
(5) $94,810,000 for fiscal year 2011.
(July 1, 1944, ch. 373, title XXIX, § 2905, as added
Pub. L. 109–442, § 2, Dec. 21, 2006, 120 Stat. 3296.)
SUBCHAPTER XXVIII—HEALTH
INFORMATION TECHNOLOGY AND QUALITY
§ 300jj. Definitions
In this subchapter:
(1) Certified EHR technology
The term ‘‘certified EHR technology’’ means
a qualified electronic health record that is cer-

§ 300jj–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tified pursuant to section 300jj–11(c)(5) of this
title as meeting standards adopted under section 300jj–14 of this title that are applicable to
the type of record involved (as determined by
the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic
health record for hospitals).
(2) Enterprise integration
The term ‘‘enterprise integration’’ means
the electronic linkage of health care providers, health plans, the government, and other
interested parties, to enable the electronic exchange and use of health information among
all the components in the health care infrastructure in accordance with applicable law,
and such term includes related application
protocols and other related standards.
(3) Health care provider
The term ‘‘health care provider’’ includes a
hospital, skilled nursing facility, nursing facility, home health entity or other long term
care facility, health care clinic, community
mental health center (as defined in section
300x–2(b)(1) of this title), renal dialysis facility, blood center, ambulatory surgical center
described in section 1395l(i) of this title,1 emergency medical services provider, Federally
qualified health center, group practice, a pharmacist, a pharmacy, a laboratory, a physician
(as defined in section 1395x(r) of this title), a
practitioner
(as
described
in
section
1395u(b)(18)(C) of this title), a provider operated by, or under contract with, the Indian
Health Service or by an Indian tribe (as defined in the Indian Self-Determination and
Education Assistance Act [25 U.S.C. 450 et
seq.]), tribal organization, or urban Indian organization (as defined in section 1603 of title
25), a rural health clinic, a covered entity
under section 256b of this title, an ambulatory
surgical center described in section 1395l(i) of
this title,1 a therapist (as defined in section
1395w–4(k)(3)(B)(iii) of this title), and any
other category of health care facility, entity,
practitioner, or clinician determined appropriate by the Secretary.
(4) Health information
The term ‘‘health information’’ has the
meaning given such term in section 1320d(4) of
this title.
(5) Health information technology
The term ‘‘health information technology’’
means hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as
services that are designed for or support the
use by health care entities or patients for the
electronic creation, maintenance, access, or
exchange of health information 2
(6) Health plan
The term ‘‘health plan’’ has the meaning
given such term in section 1320d(5) of this
title.
1 So in original. The words ‘‘ambulatory surgical center described in section 1395l(i) of this title’’ appear in two places.
2 So in original. Probably should be followed by a period.

Page 1358

(7) HIT Policy Committee
The term ‘‘HIT Policy Committee’’ means
such Committee established under section
300jj–12(a) of this title.
(8) HIT Standards Committee
The term ‘‘HIT Standards Committee’’
means such Committee established under section 300jj–13(a) of this title.
(9) Individually identifiable health information
The term ‘‘individually identifiable health
information’’ has the meaning given such
term in section 1320d(6) of this title.
(10) Laboratory
The term ‘‘laboratory’’ has the meaning
given such term in section 263a(a) of this title.
(11) National Coordinator
The term ‘‘National Coordinator’’ means the
head of the Office of the National Coordinator
for Health Information Technology established under section 300jj–11(a) of this title.
(12) Pharmacist
The term ‘‘pharmacist’’ has the meaning
given such term in section 384(2) of title 21.
(13) Qualified electronic health record
The term ‘‘qualified electronic health
record’’ means an electronic record of healthrelated information on an individual that—
(A) includes patient demographic and clinical health information, such as medical history and problem lists; and
(B) has the capacity—
(i) to provide clinical decision support;
(ii) to support physician order entry;
(iii) to capture and query information
relevant to health care quality; and
(iv) to exchange electronic health information with, and integrate such information from other sources.
(14) State
The term ‘‘State’’ means each of the several
States, the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa,
and the Northern Mariana Islands.
(July 1, 1944, ch. 373, title XXX, § 3000, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 228.)
REFERENCES IN TEXT
The Indian Self-Determination and Education Assistance Act, referred to in par. (3), is Pub. L. 93–638, Jan.
4, 1975, 88 Stat. 2203, which is classified principally to
subchapter II (§ 450 et seq.) of chapter 14 of Title 25, Indians. For complete classification of this Act to the
Code, see Short Title note set out under section 450 of
Title 25 and Tables.

PART A—PROMOTION OF HEALTH INFORMATION
TECHNOLOGY
§ 300jj–11. Office of the National Coordinator for
Health Information Technology
(a) Establishment
There is established within the Department of
Health and Human Services an Office of the National Coordinator for Health Information Technology (referred to in this section as the ‘‘Of-

Page 1359

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fice’’). The Office shall be headed by a National
Coordinator who shall be appointed by the Secretary and shall report directly to the Secretary.
(b) Purpose
The National Coordinator shall perform the
duties under subsection (c) in a manner consistent with the development of a nationwide health
information technology infrastructure that allows for the electronic use and exchange of information and that—
(1) ensures that each patient’s health information is secure and protected, in accordance
with applicable law;
(2) improves health care quality, reduces
medical errors, reduces health disparities, and
advances the delivery of patient-centered medical care;
(3) reduces health care costs resulting from
inefficiency, medical errors, inappropriate
care, duplicative care, and incomplete information;
(4) provides appropriate information to help
guide medical decisions at the time and place
of care;
(5) ensures the inclusion of meaningful public input in such development of such infrastructure;
(6) improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an
effective infrastructure for the secure and authorized exchange of health care information;
(7) improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bioterror events and infectious disease outbreaks;
(8) facilitates health and clinical research
and health care quality;
(9) promotes early detection, prevention, and
management of chronic diseases;
(10) promotes a more effective marketplace,
greater competition, greater systems analysis,
increased consumer choice, and improved outcomes in health care services; and
(11) improves efforts to reduce health disparities.
(c) Duties of the National Coordinator
(1) Standards
The National Coordinator shall—
(A) review and determine whether to endorse each standard, implementation specification, and certification criterion for the
electronic exchange and use of health information that is recommended by the HIT
Standards Committee under section 300jj–13
of this title for purposes of adoption under
section 300jj–14 of this title;
(B) make such determinations under subparagraph (A), and report to the Secretary
such determinations, not later than 45 days
after the date the recommendation is received by the Coordinator; and
(C) review Federal health information
technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published under paragraph (3).

§ 300jj–11

(2) HIT policy coordination
(A) In general
The National Coordinator shall coordinate
health information technology policy and
programs of the Department with those of
other relevant executive branch agencies
with a goal of avoiding duplication of efforts
and of helping to ensure that each agency
undertakes health information technology
activities primarily within the areas of its
greatest expertise and technical capability
and in a manner towards a coordinated national goal.
(B) HIT policy and standards committees
The National Coordinator shall be a leading member in the establishment and operations of the HIT Policy Committee and the
HIT Standards Committee and shall serve as
a liaison among those two Committees and
the Federal Government.
(3) Strategic plan
(A) In general
The National Coordinator shall, in consultation with other appropriate Federal
agencies (including the National Institute of
Standards and Technology), update the Federal Health IT Strategic Plan (developed as
of June 3, 2008) to include specific objectives,
milestones, and metrics with respect to the
following:
(i) The electronic exchange and use of
health information and the enterprise integration of such information.
(ii) The utilization of an electronic
health record for each person in the United
States by 2014.
(iii) The incorporation of privacy and security protections for the electronic exchange of an individual’s individually
identifiable health information.
(iv) Ensuring security methods to ensure
appropriate authorization and electronic
authentication of health information and
specifying technologies or methodologies
for rendering health information unusable,
unreadable, or indecipherable.
(v) Specifying a framework for coordination and flow of recommendations and
policies under this part among the Secretary, the National Coordinator, the HIT
Policy Committee, the HIT Standards
Committee, and other health information
exchanges and other relevant entities.
(vi) Methods to foster the public understanding of health information technology.
(vii) Strategies to enhance the use of
health information technology in improving the quality of health care, reducing
medical errors, reducing health disparities, improving public health, increasing
prevention and coordination with community resources, and improving the continuity of care among health care settings.
(viii) Specific plans for ensuring that
populations with unique needs, such as
children, are appropriately addressed in
the technology design, as appropriate,
which may include technology that

§ 300jj–11

TITLE 42—THE PUBLIC HEALTH AND WELFARE

automates enrollment and retention for eligible individuals.
(B) Collaboration
The strategic plan shall be updated
through collaboration of public and private
entities.
(C) Measurable outcome goals
The strategic plan update shall include
measurable outcome goals.
(D) Publication
The National Coordinator shall republish
the strategic plan, including all updates.
(4) Website
The National Coordinator shall maintain
and frequently update an Internet website on
which there is posted information on the
work, schedules, reports, recommendations,
and other information to ensure transparency
in promotion of a nationwide health information technology infrastructure.
(5) Certification
(A) In general
The National Coordinator, in consultation
with the Director of the National Institute
of Standards and Technology, shall keep or
recognize a program or programs for the voluntary certification of health information
technology as being in compliance with applicable certification criteria adopted under
this part. Such program shall include, as appropriate, testing of the technology in accordance with section 17911(b) of this title.
(B) Certification criteria described
In this subchapter, the term ‘‘certification
criteria’’ means, with respect to standards
and
implementation
specifications
for
health information technology, criteria to
establish that the technology meets such
standards and implementation specifications.
(6) Reports and publications
(A) Report on additional funding or authority needed
Not later than 12 months after February
17, 2009, the National Coordinator shall submit to the appropriate committees of jurisdiction of the House of Representatives and
the Senate a report on any additional funding or authority the Coordinator or the HIT
Policy Committee or HIT Standards Committee requires to evaluate and develop
standards, implementation specifications,
and certification criteria, or to achieve full
participation of stakeholders in the adoption
of a nationwide health information technology infrastructure that allows for the
electronic use and exchange of health information.
(B) Implementation report
The National Coordinator shall prepare a
report that identifies lessons learned from
major public and private health care systems in their implementation of health information technology, including information
on whether the technologies and practices

Page 1360

developed by such systems may be applicable to and usable in whole or in part by
other health care providers.
(C) Assessment of impact of HIT on communities with health disparities and uninsured, underinsured, and medically underserved areas
The National Coordinator shall assess and
publish the impact of health information
technology in communities with health disparities and in areas with a high proportion
of individuals who are uninsured, underinsured, and medically underserved individuals (including urban and rural areas) and
identify practices to increase the adoption of
such technology by health care providers in
such communities, and the use of health information technology to reduce and better
manage chronic diseases.
(D) Evaluation of benefits and costs of the
electronic use and exchange of health information
The National Coordinator shall evaluate
and publish evidence on the benefits and
costs of the electronic use and exchange of
health information and assess to whom these
benefits and costs accrue.
(E) Resource requirements
The National Coordinator shall estimate
and publish resources required annually to
reach the goal of utilization of an electronic
health record for each person in the United
States by 2014, including—
(i) the required level of Federal funding;
(ii) expectations for regional, State, and
private investment;
(iii) the expected contributions by volunteers to activities for the utilization of
such records; and
(iv) the resources needed to establish a
health information technology workforce
sufficient to support this effort (including
education programs in medical informatics
and health information management).
(7) Assistance
The National Coordinator may provide financial assistance to consumer advocacy
groups and not-for-profit entities that work in
the public interest for purposes of defraying
the cost to such groups and entities to participate under, whether in whole or in part, the
National Technology Transfer Act of 1995 (15
U.S.C. 272 note).1
(8) Governance for nationwide health information network
The National Coordinator shall establish a
governance mechanism for the nationwide
health information network.
(d) Detail of Federal employees
(1) In general
Upon the request of the National Coordinator, the head of any Federal agency is authorized to detail, with or without reimbursement
from the Office, any of the personnel of such
agency to the Office to assist it in carrying
out its duties under this section.
1 See

References in Text note below.

Page 1361

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Effect of detail
Any detail of personnel under paragraph (1)
shall—
(A) not interrupt or otherwise affect the
civil service status or privileges of the Federal employee; and
(B) be in addition to any other staff of the
Department employed by the National Coordinator.
(3) Acceptance of detailees
Notwithstanding any other provision of law,
the Office may accept detailed personnel from
other Federal agencies without regard to
whether the agency described under paragraph
(1) is reimbursed.
(e) Chief Privacy Officer of the Office of the National Coordinator
Not later than 12 months after February 17,
2009, the Secretary shall appoint a Chief Privacy
Officer of the Office of the National Coordinator,
whose duty it shall be to advise the National Coordinator on privacy, security, and data stewardship of electronic health information and to
coordinate with other Federal agencies (and
similar privacy officers in such agencies), with
State and regional efforts, and with foreign
countries with regard to the privacy, security,
and data stewardship of electronic individually
identifiable health information.
(July 1, 1944, ch. 373, title XXX, § 3001, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 230.)
REFERENCES IN TEXT
The National Technology Transfer Act of 1995 (15
U.S.C. 272 note), referred to in subsec. (c)(7), probably
means section 12(d) of Pub. L. 104–113, known as the National Technology Transfer and Advancement Act of
1995, which is set out as a note under section 272 of
Title 15, Commerce and Trade.

§ 300jj–12. HIT Policy Committee
(a) Establishment
There is established a HIT Policy Committee
to make policy recommendations to the National Coordinator relating to the implementation of a nationwide health information technology infrastructure, including implementation of the strategic plan described in section
300jj–11(c)(3) of this title.
(b) Duties
(1) Recommendations on health information
technology infrastructure
The HIT Policy Committee shall recommend
a policy framework for the development and
adoption of a nationwide health information
technology infrastructure that permits the
electronic exchange and use of health information as is consistent with the strategic plan
under section 300jj–11(c)(3) of this title and
that includes the recommendations under
paragraph (2). The Committee shall update
such recommendations and make new recommendations as appropriate.
(2) Specific areas of standard development
(A) In general
The HIT Policy Committee shall recommend the areas in which standards, im-

§ 300jj–12

plementation specifications, and certification criteria are needed for the electronic
exchange and use of health information for
purposes of adoption under section 300jj–14 of
this title and shall recommend an order of
priority for the development, harmonization, and recognition of such standards,
specifications, and certification criteria
among the areas so recommended. Such
standards and implementation specifications
shall include named standards, architectures, and software schemes for the authentication and security of individually identifiable health information and other information as needed to ensure the reproducible development of common solutions across disparate entities.
(B) Areas required for consideration
For purposes of subparagraph (A), the HIT
Policy Committee shall make recommendations for at least the following areas:
(i) Technologies that protect the privacy
of health information and promote security in a qualified electronic health record,
including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the
reluctance of patients to seek care (or disclose information about a condition) because of privacy concerns, in accordance
with applicable law, and for the use and
disclosure of limited data sets of such information.
(ii) A nationwide health information
technology infrastructure that allows for
the electronic use and accurate exchange
of health information.
(iii) The utilization of a certified electronic health record for each person in the
United States by 2014.
(iv) Technologies that as a part of a
qualified electronic health record allow for
an accounting of disclosures made by a
covered entity (as defined for purposes of
regulations promulgated under section
264(c) of the Health Insurance Portability
and Accountability Act of 1996) for purposes of treatment, payment, and health
care operations (as such terms are defined
for purposes of such regulations).
(v) The use of certified electronic health
records to improve the quality of health
care, such as by promoting the coordination of health care and improving continuity of health care among health care providers, by reducing medical errors, by improving population health, by reducing
health disparities, by reducing chronic disease, and by advancing research and education.
(vi) Technologies that allow individually
identifiable health information to be rendered unusable, unreadable, or indecipherable to unauthorized individuals when
such information is transmitted in the nationwide health information network or
physically transported outside of the secured, physical perimeter of a health care
provider, health plan, or health care clearinghouse.

§ 300jj–12

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(vii) The use of electronic systems to ensure the comprehensive collection of patient demographic data, including, at a
minimum, race, ethnicity, primary language, and gender information.
(viii) Technologies that address the
needs of children and other vulnerable populations.
(C) Other areas for consideration
In making recommendations under subparagraph (A), the HIT Policy Committee
may consider the following additional areas:
(i) The appropriate uses of a nationwide
health information infrastructure, including for purposes of—
(I) the collection of quality data and
public reporting;
(II) biosurveillance and public health;
(III) medical and clinical research; and
(IV) drug safety.
(ii) Self-service technologies that facilitate the use and exchange of patient information and reduce wait times.
(iii) Telemedicine technologies, in order
to reduce travel requirements for patients
in remote areas.
(iv) Technologies that facilitate home
health care and the monitoring of patients
recuperating at home.
(v) Technologies that help reduce medical errors.
(vi) Technologies that facilitate the continuity of care among health settings.
(vii) Technologies that meet the needs of
diverse populations.
(viii) Methods to facilitate secure access
by an individual to such individual’s protected health information.
(ix) Methods, guidelines, and safeguards
to facilitate secure access to patient information by a family member, caregiver, or
guardian acting on behalf of a patient due
to age-related and other disability, cognitive impairment, or dementia.
(x) Any other technology that the HIT
Policy Committee finds to be among the
technologies with the greatest potential to
improve the quality and efficiency of
health care.
(3) Forum
The HIT Policy Committee shall serve as a
forum for broad stakeholder input with specific expertise in policies relating to the matters described in paragraphs (1) and (2).
(4) Consistency with evaluation conducted
under MIPPA
(A) Requirement for consistency
The HIT Policy Committee shall ensure
that recommendations made under paragraph (2)(B)(vi) are consistent with the evaluation conducted under section 1395b–10(a) of
this title.
(B) Scope
Nothing in subparagraph (A) shall be construed to limit the recommendations under
paragraph (2)(B)(vi) to the elements described in section 1395b–10(a)(3) of this title.
(C) Timing
The requirement under subparagraph (A)
shall be applicable to the extent that evalua-

Page 1362

tions have been conducted under section
1395b–10(a) of this title, regardless of whether the report described in subsection (b) of
such section has been submitted.
(c) Membership and operations
(1) In general
The National Coordinator shall take a leading position in the establishment and operations of the HIT Policy Committee.
(2) Membership
The HIT Policy Committee shall be composed of members to be appointed as follows:
(A) 3 members shall be appointed by the
Secretary, 1 of whom shall be appointed to
represent the Department of Health and
Human Services and 1 of whom shall be a
public health official.
(B) 1 member shall be appointed by the
majority leader of the Senate.
(C) 1 member shall be appointed by the minority leader of the Senate.
(D) 1 member shall be appointed by the
Speaker of the House of Representatives.
(E) 1 member shall be appointed by the minority leader of the House of Representatives.
(F) Such other members as shall be appointed by the President as representatives
of other relevant Federal agencies.
(G) 13 members shall be appointed by the
Comptroller General of the United States of
whom—
(i) 3 members shall advocates 1 for patients or consumers;
(ii) 2 members shall represent health
care providers, one of which shall be a physician;
(iii) 1 member shall be from a labor organization representing health care workers;
(iv) 1 member shall have expertise in
health information privacy and security;
(v) 1 member shall have expertise in improving the health of vulnerable populations;
(vi) 1 member shall be from the research
community;
(vii) 1 member shall represent health
plans or other third-party payers;
(viii) 1 member shall represent information technology vendors;
(ix) 1 member shall represent purchasers
or employers; and
(x) 1 member shall have expertise in
health care quality measurement and reporting.
(3) Participation
The members of the HIT Policy Committee
appointed under paragraph (2) shall represent
a balance among various sectors of the health
care system so that no single sector unduly influences the recommendations of the Policy
Committee.
(4) Terms
(A) In general
The terms of the members of the HIT Policy Committee shall be for 3 years, except
1 So

in original.

Page 1363

TITLE 42—THE PUBLIC HEALTH AND WELFARE

that the Comptroller General shall designate
staggered terms for the members first appointed.
(B) Vacancies
Any member appointed to fill a vacancy in
the membership of the HIT Policy Committee that occurs prior to the expiration of the
term for which the member’s predecessor
was appointed shall be appointed only for
the remainder of that term. A member may
serve after the expiration of that member’s
term until a successor has been appointed. A
vacancy in the HIT Policy Committee shall
be filled in the manner in which the original
appointment was made.
(5) Outside involvement
The HIT Policy Committee shall ensure an
opportunity for the participation in activities
of the Committee of outside advisors, including individuals with expertise in the development of policies for the electronic exchange
and use of health information, including in the
areas of health information privacy and security.
(6) Quorum
A majority of the member of the HIT Policy
Committee shall constitute a quorum for purposes of voting, but a lesser number of members may meet and hold hearings.
(7) Failure of initial appointment
If, on the date that is 45 days after February
17, 2009, an official authorized under paragraph
(2) to appoint one or more members of the HIT
Policy Committee has not appointed the full
number of members that such paragraph authorizes such official to appoint, the Secretary
is authorized to appoint such members.
(8) Consideration
The National Coordinator shall ensure that
the relevant and available recommendations
and comments from the National Committee
on Vital and Health Statistics are considered
in the development of policies.
(d) Application of FACA
The Federal Advisory Committee Act (5 U.S.C.
App.), other than section 14 of such Act, shall
apply to the HIT Policy Committee.
(e) Publication
The Secretary shall provide for publication in
the Federal Register and the posting on the
Internet website of the Office of the National
Coordinator for Health Information Technology
of all policy recommendations made by the HIT
Policy Committee under this section.
(July 1, 1944, ch. 373, title XXX, § 3002, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 234.)
REFERENCES IN TEXT
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, referred to in subsec.
(b)(2)(B)(iv), is section 264(c) of Pub. L. 104–191, which is
set out as a note under section 1320d–2 of this title.
The Federal Advisory Committee Act, referred to in
subsec. (d), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.

§ 300jj–13

§ 300jj–13. HIT Standards Committee
(a) Establishment
There is established a committee to be known
as the HIT Standards Committee to recommend
to the National Coordinator standards, implementation specifications, and certification criteria for the electronic exchange and use of
health information for purposes of adoption
under section 300jj–14 of this title, consistent
with the implementation of the strategic plan
described in section 300jj–11(c)(3) of this title and
beginning with the areas listed in section
300jj–12(b)(2)(B) of this title in accordance with
policies developed by the HIT Policy Committee.
(b) Duties
(1) Standards development
(A) In general
The HIT Standards Committee shall recommend to the National Coordinator standards, implementation specifications, and
certification criteria described in subsection
(a) that have been developed, harmonized, or
recognized by the HIT Standards Committee. The HIT Standards Committee shall update such recommendations and make new
recommendations as appropriate, including
in response to a notification sent under section 300jj–14(a)(2)(B) of this title. Such recommendations shall be consistent with the
latest recommendations made by the HIT
Policy Committee.
(B) Harmonization
The HIT Standards Committee recognize 1
harmonized or updated standards from an
entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of the
standards and implementation specifications.
(C) Pilot testing of standards and implementation specifications
In the development, harmonization, or recognition of standards and implementation
specifications, the HIT Standards Committee shall, as appropriate, provide for the
testing of such standards and specifications
by the National Institute for Standards and
Technology under section 17911(a) of this
title.
(D) Consistency
The standards, implementation specifications,
and
certification
criteria
recommended under this subsection shall be
consistent with the standards for information transactions and data elements adopted
pursuant to section 1320d–2 of this title.
(2) Forum
The HIT Standards Committee shall serve as
a forum for the participation of a broad range
of stakeholders to provide input on the development, harmonization, and recognition of
standards, implementation specifications, and
1 So

in original.

§ 300jj–14

TITLE 42—THE PUBLIC HEALTH AND WELFARE

certification criteria necessary for the development and adoption of a nationwide health
information technology infrastructure that allows for the electronic use and exchange of
health information.
(3) Schedule
Not later than 90 days after February 17,
2009, the HIT Standards Committee shall develop a schedule for the assessment of policy
recommendations developed by the HIT Policy
Committee under section 300jj–12 of this title.
The HIT Standards Committee shall update
such schedule annually. The Secretary shall
publish such schedule in the Federal Register.
(4) Public input
The HIT Standards Committee shall conduct
open public meetings and develop a process to
allow for public comment on the schedule described in paragraph (3) and recommendations
described in this subsection. Under such process comments shall be submitted in a timely
manner after the date of publication of a recommendation under this subsection.
(5) Consideration
The National Coordinator shall ensure that
the relevant and available recommendations
and comments from the National Committee
on Vital and Health Statistics are considered
in the development of standards.
(c) Membership and operations
(1) In general
The National Coordinator shall take a leading position in the establishment and operations of the HIT Standards Committee.
(2) Membership
The membership of the HIT Standards Committee shall at least reflect providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care
quality, privacy and security, and on the electronic exchange and use of health information.
(3) Participation
The members of the HIT Standards Committee appointed under this subsection shall represent a balance among various sectors of the
health care system so that no single sector unduly influences the recommendations of such
Committee.
(4) Outside involvement
The HIT Policy Committee shall ensure an
opportunity for the participation in activities
of the Committee of outside advisors, including individuals with expertise in the development of standards for the electronic exchange
and use of health information, including in the
areas of health information privacy and security.
(5) Balance among sectors
In developing the procedures for conducting
the activities of the HIT Standards Committee, the HIT Standards Committee shall act to
ensure a balance among various sectors of the
health care system so that no single sector un-

Page 1364

duly influences the actions of the HIT Standards Committee.
(6) Assistance
For the purposes of carrying out this section, the Secretary may provide or ensure that
financial assistance is provided by the HIT
Standards Committee to defray in whole or in
part any membership fees or dues charged by
such Committee to those consumer advocacy
groups and not for profit entities that work in
the public interest as a part of their mission.
(d) Application of FACA
The Federal Advisory Committee Act (5 U.S.C.
App.), other than section 14, shall apply to the
HIT Standards Committee.
(e) Publication
The Secretary shall provide for publication in
the Federal Register and the posting on the
Internet website of the Office of the National
Coordinator for Health Information Technology
of all recommendations made by the HIT Standards Committee under this section.
(July 1, 1944, ch. 373, title XXX, § 3003, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 238.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (d), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.

§ 300jj–14. Process for adoption of endorsed recommendations; adoption of initial set of
standards, implementation specifications,
and certification criteria
(a) Process for adoption of endorsed recommendations
(1) Review of endorsed standards, implementation specifications, and certification criteria
Not later than 90 days after the date of receipt of standards, implementation specifications, or certification criteria endorsed under
section 300jj–11(c) of this title, the Secretary,
in consultation with representatives of other
relevant Federal agencies, shall jointly review
such standards, implementation specifications, or certification criteria and shall determine whether or not to propose adoption of
such standards, implementation specifications, or certification criteria.
(2) Determination to adopt standards, implementation specifications, and certification
criteria
If the Secretary determines—
(A) to propose adoption of any grouping of
such standards, implementation specifications, or certification criteria, the Secretary
shall, by regulation under section 553 of title
5, determine whether or not to adopt such
grouping of standards, implementation specifications, or certification criteria; or
(B) not to propose adoption of any grouping of standards, implementation specifications, or certification criteria, the Secretary
shall notify the National Coordinator and

Page 1365

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the HIT Standards Committee in writing of
such determination and the reasons for not
proposing the adoption of such recommendation.
(3) Publication
The Secretary shall provide for publication
in the Federal Register of all determinations
made by the Secretary under paragraph (1).
(b) Adoption of standards, implementation specifications, and certification criteria
(1) In general
Not later than December 31, 2009, the Secretary shall, through the rulemaking process
consistent with subsection (a)(2)(A), adopt an
initial set of standards, implementation specifications, and certification criteria for the
areas required for consideration under section
300jj–12(b)(2)(B) of this title. The rulemaking
for the initial set of standards, implementation specifications, and certification criteria
may be issued on an interim, final basis.
(2) Application of current standards, implementation specifications, and certification
criteria
The standards, implementation specifications, and certification criteria adopted before
February 17, 2009, through the process existing
through the Office of the National Coordinator
for Health Information Technology may be applied towards meeting the requirement of
paragraph (1).
(3) Subsequent standards activity
The Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent
with the schedule published under section
300jj–13(b)(2) 1 of this title.
(July 1, 1944, ch. 373, title XXX, § 3004, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 240.)
§ 300jj–15. Application and use of adopted standards and implementation specifications by
Federal agencies
For requirements relating to the application
and use by Federal agencies of the standards and
implementation specifications adopted under
section 300jj–14 of this title, see section 17901 of
this title.
(July 1, 1944, ch. 373, title XXX, § 3005, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 241.)
§ 300jj–16. Voluntary application and use of
adopted standards and implementation specifications by private entities
(a) In general
Except as provided under section 13112 of the
HITECH Act [42 U.S.C. 17902], nothing in such
Act or in the amendments made by such Act
shall be construed—
(1) to require a private entity to adopt or
comply with a standard or implementation
1 So in original. Probably should be a reference to section
300jj–13(b)(3).

§ 300jj–17

specification adopted under section 300jj–14 of
this title; or
(2) to provide a Federal agency authority,
other than the authority such agency may
have under other provisions of law, to require
a private entity to comply with such a standard or implementation specification.
(b) Rule of construction
Nothing in this part shall be construed to require that a private entity that enters into a
contract with the Federal Government apply or
use the standards and implementation specifications adopted under section 300jj–14 of this title
with respect to activities not related to the contract.
(July 1, 1944, ch. 373, title XXX, § 3006, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 241.)
REFERENCES IN TEXT
The HITECH Act, referred to in subsec. (a), is title
XIII of div. A and title IV of div. B of Pub. L. 111–5, Feb.
17, 2009, 123 Stat. 226, 467, also known as the Health Information Technology for Economic and Clinical
Health Act. For complete classification of this Act to
the Code, see Short Title of 2009 Amendment note set
out under section 201 of this title and Tables.

§ 300jj–17. Federal health information technology
(a) In general
The National Coordinator shall support the development and routine updating of qualified
electronic health record technology (as defined
in section 300jj of this title) consistent with subsections (b) and (c) and make available such
qualified electronic health record technology
unless the Secretary determines through an assessment that the needs and demands of providers are being substantially and adequately met
through the marketplace.
(b) Certification
In making such electronic health record technology publicly available, the National Coordinator shall ensure that the qualified electronic health record technology described in
subsection (a) is certified under the program developed under section 300jj–11(c)(3) of this title
to be in compliance with applicable standards
adopted under section 300jj–13(a) of this title.
(c) Authorization to charge a nominal fee
The National Coordinator may impose a nominal fee for the adoption by a health care provider of the health information technology system developed or approved under subsection 1 (a)
and (b). Such fee shall take into account the financial circumstances of smaller providers, low
income providers, and providers located in rural
or other medically underserved areas.
(d) Rule of construction
Nothing in this section shall be construed to
require that a private or government entity
adopt or use the technology provided under this
section.
(July 1, 1944, ch. 373, title XXX, § 3007, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 241.)
1 So

in original. Probably should be ‘‘subsections’’.

§ 300jj–18

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 300jj–18. Transitions
(a) ONCHIT
To the extent consistent with section 300jj–11
of this title, all functions, personnel, assets, liabilities, and administrative actions applicable
to the National Coordinator for Health Information Technology appointed under Executive
Order No. 13335 or the Office of such National
Coordinator on the date before February 17, 2009,
shall be transferred to the National Coordinator
appointed under section 300jj–11(a) of this title
and the Office of such National Coordinator as
of February 17, 2009.
(b) National eHealth Collaborative
Nothing in sections 1 300jj–12 or 300jj–13 of this
title or this subsection shall be construed as
prohibiting the AHIC Successor, Inc. doing business as the National eHealth Collaborative from
modifying its charter, duties, membership, and
any other structure or function required to be
consistent with section 2 300jj–12 and 300jj–13 of
this title so as to allow the Secretary to recognize such AHIC Successor, Inc. as the HIT Policy
Committee or the HIT Standards Committee.
(c) Consistency of recommendations
In carrying out section 300jj–13(b)(1)(A) of this
title, until recommendations are made by the
HIT Policy Committee, recommendations of the
HIT Standards Committee shall be consistent
with the most recent recommendations made by
such AHIC Successor, Inc.
(July 1, 1944, ch. 373, title XXX, § 3008, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 241.)
REFERENCES IN TEXT
Executive Order No. 13335, referred to in subsec. (a),
is set out as a note under section 300u of this title.

§ 300jj–19. Miscellaneous provisions
(a) Relation to HIPAA privacy and security law
(1) In general
With respect to the relation of this subchapter to HIPAA privacy and security law:
(A) This subchapter may not be construed
as having any effect on the authorities of
the Secretary under HIPAA privacy and security law.
(B) The purposes of this subchapter include ensuring that the health information
technology standards and implementation
specifications adopted under section 300jj–14
of this title take into account the requirements of HIPAA privacy and security law.
(2) Definition
For purposes of this section, the term
‘‘HIPAA privacy and security law’’ means—
(A) the provisions of part C of title XI of
the Social Security Act [42 U.S.C. 1320d et
seq.], section 264 of the Health Insurance
Portability and Accountability Act of 1996,
and subtitle D of title IV 1 of the Health Information Technology for Economic and
Clinical Health Act; and
(B) regulations under such provisions.
1 So

in original. Probably should be ‘‘section’’.
in original. Probably should be ‘‘sections’’.
1 See References in Text note below.
2 So

Page 1366

(b) Flexibility
In administering the provisions of this subchapter, the Secretary shall have flexibility in
applying the definition of health care provider
under section 300jj(3) of this title, including the
authority to omit certain entities listed in such
definition when applying such definition under
this subchapter, where appropriate.
(July 1, 1944, ch. 373, title XXX, § 3009, as added
Pub. L. 111–5, div. A, title XIII, § 13101, Feb. 17,
2009, 123 Stat. 242.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(a)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Part
C of title XI of the Act is classified generally to part
C (§ 1320d et seq.) of subchapter XI of chapter 7 of this
title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
Section 264 of the Health Insurance Portability and
Accountability Act of 1996, referred to subsec. (a)(2)(A),
is section 264 of Pub. L. 104–191, which is set out as a
note under section 1320d–2 of this title.
The Health Information Technology for Economic
and Clinical Health Act, referred to in subsec. (a)(2)(A),
is title XIII of div. A and title IV of div. B of Pub. L.
111–5, Feb. 17, 2009, 123 Stat. 226, 467, also known as the
HITECH Act. Subtitle D of title IV of the Act probably
means subtitle D of title XIII of div. A of the Act,
which is classified generally to subchapter III (§ 17921 et
seq.) of chapter 156 of this title. Title IV of div. B of the
Act does not contain a subtitle D. For complete classification of this Act to the Code, see Short Title of 2009
Amendment note set out under section 201 of this title
and Tables.

PART B—INCENTIVES FOR THE USE OF HEALTH
INFORMATION TECHNOLOGY
§ 300jj–31. Immediate funding to strengthen the
health information technology infrastructure
(a) In general
The Secretary shall, using amounts appropriated under section 300jj–38 of this title, invest
in the infrastructure necessary to allow for and
promote the electronic exchange and use of
health information for each individual in the
United States consistent with the goals outlined
in the strategic plan developed by the National
Coordinator (and as available) under section
300jj–11 of this title. The Secretary shall invest
funds through the different agencies with expertise in such goals, such as the Office of the National Coordinator for Health Information Technology, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, the Centers of Medicare &
Medicaid Services, the Centers for Disease Control and Prevention, and the Indian Health Service to support the following:
(1) Health information technology architecture that will support the nationwide electronic exchange and use of health information
in a secure, private, and accurate manner, including connecting health information exchanges, and which may include updating and
implementing the infrastructure necessary
within different agencies of the Department of
Health and Human Services to support the
electronic use and exchange of health information.
(2) Development and adoption of appropriate
certified electronic health records for cat-

Page 1367

TITLE 42—THE PUBLIC HEALTH AND WELFARE

egories of health care providers not eligible for
support under title XVIII or XIX of the Social
Security Act [42 U.S.C. 1395 et seq., 1396 et
seq.] for the adoption of such records.
(3) Training on and dissemination of information on best practices to integrate health
information technology, including electronic
health records, into a provider’s delivery of
care, consistent with best practices learned
from the Health Information Technology Research Center developed under section
300jj–32(b) of this title, including community
health centers receiving assistance under section 254b of this title, covered entities under
section 256b of this title, and providers participating in one or more of the programs under
titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq.,
1397aa et seq.] (relating to Medicare, Medicaid,
and the State Children’s Health Insurance
Program).
(4) Infrastructure and tools for the promotion of telemedicine, including coordination among Federal agencies in the promotion
of telemedicine.
(5) Promotion of the interoperability of clinical data repositories or registries.
(6) Promotion of technologies and best practices that enhance the protection of health information by all holders of individually identifiable health information.
(7) Improvement and expansion of the use of
health information technology by public
health departments.
(b) Coordination
The Secretary shall ensure funds under this
section are used in a coordinated manner with
other health information promotion activities.
(c) Additional use of funds
In addition to using funds as provided in subsection (a), the Secretary may use amounts appropriated under section 300jj–38 of this title to
carry out health information technology activities that are provided for under laws in effect on
February 17, 2009.
(d) Standards for acquisition of health information technology
To the greatest extent practicable, the Secretary shall ensure that where funds are expended under this section for the acquisition of
health information technology, such funds shall
be used to acquire health information technology that meets applicable standards adopted
under section 300jj–14 of this title. Where it is
not practicable to expend funds on health information technology that meets such applicable
standards, the Secretary shall ensure that such
health information technology meets applicable
standards otherwise adopted by the Secretary.
(July 1, 1944, ch. 373, title XXX, § 3011, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 246.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsec. (a)(2),
(3), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles
XVIII, XIX, and XXI of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.) of chapter 7 of this title, re-

§ 300jj–32

spectively. For complete classification of this Act to
the Code, see section 1305 of this title and Tables.

§ 300jj–32. Health information technology implementation assistance
(a) Health information technology extension program
To assist health care providers to adopt, implement, and effectively use certified EHR technology that allows for the electronic exchange
and use of health information, the Secretary,
acting through the Office of the National Coordinator, shall establish a health information
technology extension program to provide health
information technology assistance services to be
carried out through the Department of Health
and Human Services. The National Coordinator
shall consult with other Federal agencies with
demonstrated experience and expertise in information technology services, such as the National Institute of Standards and Technology, in
developing and implementing this program.
(b) Health Information Technology Research
Center
(1) In general
The Secretary shall create a Health Information Technology Research Center (in this
section referred to as the ‘‘Center’’) to provide
technical assistance and develop or recognize
best practices to support and accelerate efforts to adopt, implement, and effectively utilize health information technology that allows
for the electronic exchange and use of information in compliance with standards, implementation specifications, and certification
criteria adopted under section 300jj–14 of this
title.
(2) Input
The Center shall incorporate input from—
(A) other Federal agencies with demonstrated experience and expertise in information technology services such as the National Institute of Standards and Technology;
(B) users of health information technology, such as providers and their support
and clerical staff and others involved in the
care and care coordination of patients, from
the health care and health information technology industry; and
(C) others as appropriate.
(3) Purposes
The purposes of the Center are to—
(A) provide a forum for the exchange of
knowledge and experience;
(B) accelerate the transfer of lessons
learned from existing public and private sector initiatives, including those currently receiving Federal financial support;
(C) assemble, analyze, and widely disseminate evidence and experience related to the
adoption, implementation, and effective use
of health information technology that allows for the electronic exchange and use of
information including through the regional
centers described in subsection (c);
(D) provide technical assistance for the establishment and evaluation of regional and

§ 300jj–32

TITLE 42—THE PUBLIC HEALTH AND WELFARE

local health information networks to facilitate the electronic exchange of information
across health care settings and improve the
quality of health care;
(E) provide technical assistance for the development and dissemination of solutions to
barriers to the exchange of electronic health
information; and
(F) learn about effective strategies to
adopt and utilize health information technology in medically underserved communities.
(c) Health information technology regional extension centers
(1) In general
The Secretary shall provide assistance for
the creation and support of regional centers
(in this subsection referred to as ‘‘regional
centers’’) to provide technical assistance and
disseminate best practices and other information learned from the Center to support and
accelerate efforts to adopt, implement, and effectively utilize health information technology that allows for the electronic exchange
and use of information in compliance with
standards, implementation specifications, and
certification criteria adopted under section
300jj–14 of this title. Activities conducted
under this subsection shall be consistent with
the strategic plan developed by the National
Coordinator, (and, as available) under section
300jj–11 of this title.
(2) Affiliation
Regional centers shall be affiliated with any
United States-based nonprofit institution or
organization, or group thereof, that applies
and is awarded financial assistance under this
section. Individual awards shall be decided on
the basis of merit.
(3) Objective
The objective of the regional centers is to
enhance and promote the adoption of health
information technology through—
(A) assistance with the implementation,
effective use, upgrading, and ongoing maintenance of health information technology,
including electronic health records, to
healthcare providers nationwide;
(B) broad participation of individuals from
industry, universities, and State governments;
(C) active dissemination of best practices
and research on the implementation, effective use, upgrading, and ongoing maintenance of health information technology, including electronic health records, to health
care providers in order to improve the quality of healthcare and protect the privacy and
security of health information;
(D) participation, to the extent practicable, in health information exchanges;
(E) utilization, when appropriate, of the
expertise and capability that exists in Federal agencies other than the Department;
and
(F) integration of health information technology, including electronic health records,
into the initial and ongoing training of
health professionals and others in the

Page 1368

healthcare industry that would be instrumental to improving the quality of healthcare through the smooth and accurate electronic use and exchange of health information.
(4) Regional assistance
Each regional center shall aim to provide assistance and education to all providers in a region, but shall prioritize any direct assistance
first to the following:
(A) Public or not-for-profit hospitals or
critical access hospitals.
(B) Federally qualified health centers (as
defined in section 1395x(aa)(4) of this title).
(C) Entities that are located in rural and
other areas that serve uninsured, underinsured, and medically underserved individuals (regardless of whether such area is
urban or rural).
(D) Individual or small group practices (or
a consortium thereof) that are primarily focused on primary care.
(5) Financial support
The Secretary may provide financial support
to any regional center created under this subsection for a period not to exceed four years.
The Secretary may not provide more than 50
percent of the capital and annual operating
and maintenance funds required to create and
maintain such a center, except in an instance
of national economic conditions which would
render this cost-share requirement detrimental to the program and upon notification to
Congress as to the justification to waive the
cost-share requirement.
(6) Notice of program description and availability of funds
The Secretary shall publish in the Federal
Register, not later than 90 days after February
17, 2009, a draft description of the program for
establishing regional centers under this subsection. Such description shall include the following:
(A) A detailed explanation of the program
and the programs 1 goals.
(B) Procedures to be followed by the applicants.
(C) Criteria for determining qualified applicants.
(D) Maximum support levels expected to be
available to centers under the program.
(7) Application review
The Secretary shall subject each application
under this subsection to merit review. In making a decision whether to approve such application and provide financial support, the Secretary shall consider at a minimum the merits
of the application, including those portions of
the application regarding—
(A) the ability of the applicant to provide
assistance under this subsection and utilization of health information technology appropriate to the needs of particular categories
of health care providers;
(B) the types of service to be provided to
health care providers;
1 So

in original.

Page 1369

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) geographical diversity and extent of
service area; and
(D) the percentage of funding and amount
of in-kind commitment from other sources.
(8) Biennial evaluation
Each regional center which receives financial assistance under this subsection shall be
evaluated biennially by an evaluation panel
appointed by the Secretary. Each evaluation
panel shall be composed of private experts,
none of whom shall be connected with the center involved, and of Federal officials. Each
evaluation panel shall measure the involved
center’s performance against the objective
specified in paragraph (3). The Secretary shall
not continue to provide funding to a regional
center unless its evaluation is overall positive.
(9) Continuing support
After the second year of assistance under
this subsection, a regional center may receive
additional support under this subsection if it
has received positive evaluations and a finding
by the Secretary that continuation of Federal
funding to the center was in the best interest
of provision of health information technology
extension services.
(July 1, 1944, ch. 373, title XXX, § 3012, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 247.)
§ 300jj–33. State grants to promote health information technology
(a) In general
The Secretary, acting through the National
Coordinator, shall establish a program in accordance with this section to facilitate and expand the electronic movement and use of health
information among organizations according to
nationally recognized standards.
(b) Planning grants
The Secretary may award a grant to a State
or qualified State-designated entity (as described in subsection (f)) that submits an application to the Secretary at such time, in such
manner, and containing such information as the
Secretary may specify, for the purpose of planning activities described in subsection (d).
(c) Implementation grants
The Secretary may award a grant to a State
or qualified State designated 1 entity that—
(1) has submitted, and the Secretary has approved, a plan described in subsection (e) (regardless of whether such plan was prepared
using amounts awarded under subsection (b); 2
and
(2) submits an application at such time, in
such manner, and containing such information
as the Secretary may specify.
(d) Use of funds
Amounts received under a grant under subsection (c) shall be used to conduct activities to
facilitate and expand the electronic movement
and use of health information among organiza1 So

in original. Probably should be ‘‘State-designated’’.
in original. Another closing parenthesis probably should
precede the semicolon.
2 So

§ 300jj–33

tions according to nationally recognized standards through activities that include—
(1) enhancing broad and varied participation
in the authorized and secure nationwide electronic use and exchange of health information;
(2) identifying State or local resources available towards a nationwide effort to promote
health information technology;
(3) complementing other Federal grants, programs, and efforts towards the promotion of
health information technology;
(4) providing technical assistance for the development and dissemination of solutions to
barriers to the exchange of electronic health
information;
(5) promoting effective strategies to adopt
and utilize health information technology in
medically underserved communities;
(6) assisting patients in utilizing health information technology;
(7) encouraging clinicians to work with
Health Information Technology Regional Extension Centers as described in section 300jj–32
of this title, to the extent they are available
and valuable;
(8) supporting public health agencies’ authorized use of and access to electronic health
information;
(9) promoting the use of electronic health
records for quality improvement including
through quality measures reporting; and
(10) such other activities as the Secretary
may specify.
(e) Plan
(1) In general
A plan described in this subsection is a plan
that describes the activities to be carried out
by a State or by the qualified State-designated
entity within such State to facilitate and expand the electronic movement and use of
health information among organizations according to nationally recognized standards
and implementation specifications.
(2) Required elements
A plan described in paragraph (1) shall—
(A) be pursued in the public interest;
(B) be consistent with the strategic plan
developed by the National Coordinator, (and,
as available) under section 300jj–11 of this
title;
(C) include a description of the ways the
State or qualified State-designated entity
will carry out the activities described in
subsection (b); and
(D) contain such elements as the Secretary
may require.
(f) Qualified State-designated entity
For purposes of this section, to be a qualified
State-designated entity, with respect to a State,
an entity shall—
(1) be designated by the State as eligible to
receive awards under this section;
(2) be a not-for-profit entity with broad
stakeholder representation on its governing
board;
(3) demonstrate that one of its principal
goals is to use information technology to improve health care quality and efficiency
through the authorized and secure electronic
exchange and use of health information;

§ 300jj–34

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(4) adopt nondiscrimination and conflict of
interest policies that demonstrate a commitment to open, fair, and nondiscriminatory participation by stakeholders; and
(5) conform to such other requirements as
the Secretary may establish.
(g) Required consultation
In carrying out activities described in subsections (b) and (c), a State or qualified Statedesignated entity shall consult with and consider the recommendations of—
(1) health care providers (including providers
that provide services to low income and underserved populations);
(2) health plans;
(3) patient or consumer organizations that
represent the population to be served;
(4) health information technology vendors;
(5) health care purchasers and employers;
(6) public health agencies;
(7) health professions schools, universities
and colleges;
(8) clinical researchers;
(9) other users of health information technology such as the support and clerical staff of
providers and others involved in the care and
care coordination of patients; and
(10) such other entities, as may be determined appropriate by the Secretary.
(h) Continuous improvement
The Secretary shall annually evaluate the activities conducted under this section and shall,
in awarding grants under this section, implement the lessons learned from such evaluation
in a manner so that awards made subsequent to
each such evaluation are made in a manner
that, in the determination of the Secretary, will
lead towards the greatest improvement in quality of care, decrease in costs, and the most effective authorized and secure electronic exchange
of health information.
(i) Required match
(1) In general
For a fiscal year (beginning with fiscal year
2011), the Secretary may not make a grant
under this section to a State unless the State
agrees to make available non-Federal contributions (which may include in-kind contributions) toward the costs of a grant awarded under subsection (c) in an amount equal
to—
(A) for fiscal year 2011, not less than $1 for
each $10 of Federal funds provided under the
grant;
(B) for fiscal year 2012, not less than $1 for
each $7 of Federal funds provided under the
grant; and
(C) for fiscal year 2013 and each subsequent
fiscal year, not less than $1 for each $3 of
Federal funds provided under the grant.
(2) Authority to require State match for fiscal
years before fiscal year 2011
For any fiscal year during the grant program under this section before fiscal year 2011,
the Secretary may determine the extent to
which there shall be required a non-Federal
contribution from a State receiving a grant
under this section.

Page 1370

(July 1, 1944, ch. 373, title XXX, § 3013, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 250.)
§ 300jj–34. Competitive grants to States and Indian tribes for the development of loan programs to facilitate the widespread adoption
of certified EHR technology
(a) In general
The National Coordinator may award competitive grants to eligible entities for the establishment of programs for loans to health care providers to conduct the activities described in subsection (e).
(b) Eligible entity defined
For purposes of this subsection, the term ‘‘eligible entity’’ means a State or Indian tribe (as
defined in the Indian Self-Determination and
Education Assistance Act [25 U.S.C. 450 et seq.])
that—
(1) submits to the National Coordinator an
application at such time, in such manner, and
containing such information as the National
Coordinator may require;
(2) submits to the National Coordinator a
strategic plan in accordance with subsection
(d) and provides to the National Coordinator
assurances that the entity will update such
plan annually in accordance with such subsection;
(3) provides assurances to the National Coordinator that the entity will establish a Loan
Fund in accordance with subsection (c);
(4) provides assurances to the National Coordinator that the entity will not provide a
loan from the Loan Fund to a health care provider unless the provider agrees to—
(A) submit reports on quality measures
adopted by the Federal Government (by not
later than 90 days after the date on which
such measures are adopted), to—
(i) the Administrator of the Centers for
Medicare & Medicaid Services (or his or
her designee), in the case of an entity participating in the Medicare program under
title XVIII of the Social Security Act [42
U.S.C. 1395 et seq.] or the Medicaid program under title XIX of such Act [42 U.S.C.
1396 et seq.]; or
(ii) the Secretary in the case of other entities;
(B) demonstrate to the satisfaction of the
Secretary (through criteria established by
the Secretary) that any certified EHR technology purchased, improved, or otherwise financially supported under a loan under this
section is used to exchange health information in a manner that, in accordance with
law and standards (as adopted under section
300jj–14 of this title) applicable to the exchange of information, improves the quality
of health care, such as promoting care coordination; and 1
(C) comply with such other requirements
as the entity or the Secretary may require;
(D) include a plan on how health care providers involved intend to maintain and support the certified EHR technology over time;
1 So in original. The word ‘‘and’’ probably should appear at end
of subpar. (D).

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(E) include a plan on how the health care
providers involved intend to maintain and
support the certified EHR technology that
would be purchased with such loan, including the type of resources expected to be involved and any such other information as
the State or Indian Tribe, respectively, may
require; and
(5) agrees to provide matching funds in accordance with subsection (h).
(c) Establishment of fund
For purposes of subsection (b)(3), an eligible
entity shall establish a certified EHR technology loan fund (referred to in this subsection
as a ‘‘Loan Fund’’) and comply with the other
requirements contained in this section. A grant
to an eligible entity under this section shall be
deposited in the Loan Fund established by the
eligible entity. No funds authorized by other
provisions of this subchapter to be used for
other purposes specified in this subchapter shall
be deposited in any Loan Fund.
(d) Strategic plan
(1) In general
For purposes of subsection (b)(2), a strategic
plan of an eligible entity under this subsection
shall identify the intended uses of amounts
available to the Loan Fund of such entity.
(2) Contents
A strategic plan under paragraph (1), with
respect to a Loan Fund of an eligible entity,
shall include for a year the following:
(A) A list of the projects to be assisted
through the Loan Fund during such year.
(B) A description of the criteria and methods established for the distribution of funds
from the Loan Fund during the year.
(C) A description of the financial status of
the Loan Fund as of the date of submission
of the plan.
(D) The short-term and long-term goals of
the Loan Fund.
(e) Use of funds
Amounts deposited in a Loan Fund, including
loan repayments and interest earned on such
amounts, shall be used only for awarding loans
or loan guarantees, making reimbursements described in subsection (g)(4)(A), or as a source of
reserve and security for leveraged loans, the
proceeds of which are deposited in the Loan
Fund established under subsection (c). Loans
under this section may be used by a health care
provider to—
(1) facilitate the purchase of certified EHR
technology;
(2) enhance the utilization of certified EHR
technology (which may include costs associated with upgrading health information technology so that it meets criteria necessary to
be a certified EHR technology);
(3) train personnel in the use of such technology; or
(4) improve the secure electronic exchange of
health information.
(f) Types of assistance
Except as otherwise limited by applicable
State law, amounts deposited into a Loan Fund

§ 300jj–34

under this section may only be used for the following:
(1) To award loans that comply with the following:
(A) The interest rate for each loan shall
not exceed the market interest rate.
(B) The principal and interest payments on
each loan shall commence not later than 1
year after the date the loan was awarded,
and each loan shall be fully amortized not
later than 10 years after the date of the loan.
(C) The Loan Fund shall be credited with
all payments of principal and interest on
each loan awarded from the Loan Fund.
(2) To guarantee, or purchase insurance for,
a local obligation (all of the proceeds of which
finance a project eligible for assistance under
this subsection) if the guarantee or purchase
would improve credit market access or reduce
the interest rate applicable to the obligation
involved.
(3) As a source of revenue or security for the
payment of principal and interest on revenue
or general obligation bonds issued by the eligible entity if the proceeds of the sale of the
bonds will be deposited into the Loan Fund.
(4) To earn interest on the amounts deposited into the Loan Fund.
(5) To make reimbursements described in
subsection (g)(4)(A).
(g) Administration of loan funds
(1) Combined financial administration
An eligible entity may (as a convenience and
to avoid unnecessary administrative costs)
combine, in accordance with applicable State
law, the financial administration of a Loan
Fund established under this subsection with
the financial administration of any other revolving fund established by the entity if otherwise not prohibited by the law under which
the Loan Fund was established.
(2) Cost of administering fund
Each eligible entity may annually use not to
exceed 4 percent of the funds provided to the
entity under a grant under this section to pay
the reasonable costs of the administration of
the programs under this section, including the
recovery of reasonable costs expended to establish a Loan Fund which are incurred after
February 17, 2009.
(3) Guidance and regulations
The National Coordinator shall publish guidance and promulgate regulations as may be
necessary to carry out the provisions of this
section, including—
(A) provisions to ensure that each eligible
entity commits and expends funds allotted
to the entity under this section as efficiently as possible in accordance with this
subchapter and applicable State laws; and
(B) guidance to prevent waste, fraud, and
abuse.
(4) Private sector contributions
(A) In general
A Loan Fund established under this section may accept contributions from private
sector entities, except that such entities

§ 300jj–35

TITLE 42—THE PUBLIC HEALTH AND WELFARE

may not specify the recipient or recipients
of any loan issued under this subsection. An
eligible entity may agree to reimburse a private sector entity for any contribution made
under this subparagraph, except that the
amount of such reimbursement may not be
greater than the principal amount of the
contribution made.
(B) Availability of information
An eligible entity shall make publicly
available the identity of, and amount contributed by, any private sector entity under
subparagraph (A) and may issue letters of
commendation or make other awards (that
have no financial value) to any such entity.
(h) Matching requirements
(1) In general
The National Coordinator may not make a
grant under subsection (a) to an eligible entity
unless the entity agrees to make available (directly or through donations from public or private entities) non-Federal contributions in
cash to the costs of carrying out the activities
for which the grant is awarded in an amount
equal to not less than $1 for each $5 of Federal
funds provided under the grant.
(2) Determination of amount of non-Federal
contribution
In determining the amount of non-Federal
contributions that an eligible entity has provided pursuant to subparagraph (A),2 the National Coordinator may not include any
amounts provided to the entity by the Federal
Government.
(i) Effective date
The Secretary may not make an award under
this section prior to January 1, 2010.
(July 1, 1944, ch. 373, title XXX, § 3014, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 253.)
REFERENCES IN TEXT
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (b), is Pub. L. 93–638,
Jan. 4, 1975, 88 Stat. 2203, which is classified principally
to subchapter II (§ 450 et seq.) of chapter 14 of Title 25,
Indians. For complete classification of this Act to the
Code, see Short Title note set out under section 450 of
Title 25 and Tables.
The Social Security Act, referred to in subsec.
(b)(4)(A)(i), is act Aug. 14, 1935, ch. 531, 49 Stat. 620.
Titles XVIII and XIX of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.) and XIX (§ 1396 et
seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section
1305 of this title and Tables.

§ 300jj–35. Demonstration program to integrate
information technology into clinical education
(a) In general
The Secretary may award grants under this
section to carry out demonstration projects to
develop academic curricula integrating certified
EHR technology in the clinical education of
health professionals. Such awards shall be made
2 So

in original. Probably means ‘‘paragraph (1),’’.

Page 1372

on a competitive basis and pursuant to peer review.
(b) Eligibility
To be eligible to receive a grant under subsection (a), an entity shall—
(1) submit to the Secretary an application at
such time, in such manner, and containing
such information as the Secretary may require;
(2) submit to the Secretary a strategic plan
for integrating certified EHR technology in
the clinical education of health professionals
to reduce medical errors, increase access to
prevention, reduce chronic diseases, and enhance health care quality;
(3) be—
(A) a school of medicine, osteopathic medicine, dentistry, or pharmacy, a graduate program in behavioral or mental health, or any
other graduate health professions school;
(B) a graduate school of nursing or physician assistant studies;
(C) a consortium of two or more schools
described in subparagraph (A) or (B); or
(D) an institution with a graduate medical
education program in medicine, osteopathic
medicine, dentistry, pharmacy, nursing, or
physician assistance studies;
(4) provide for the collection of data regarding the effectiveness of the demonstration
project to be funded under the grant in improving the safety of patients, the efficiency
of health care delivery, and in increasing the
likelihood that graduates of the grantee will
adopt and incorporate certified EHR technology, in the delivery of health care services;
and
(5) provide matching funds in accordance
with subsection (d).
(c) Use of funds
(1) In general
With respect to a grant under subsection (a),
an eligible entity shall—
(A) use grant funds in collaboration with 2
or more disciplines; and
(B) use grant funds to integrate certified
EHR technology into community-based clinical education.
(2) Limitation
An eligible entity shall not use amounts received under a grant under subsection (a) to
purchase hardware, software, or services.
(d) Financial support
The Secretary may not provide more than 50
percent of the costs of any activity for which assistance is provided under subsection (a), except
in an instance of national economic conditions
which would render the cost-share requirement
under this subsection detrimental to the program and upon notification to Congress as to
the justification to waive the cost-share requirement.
(e) Evaluation
The Secretary shall take such action as may
be necessary to evaluate the projects funded
under this section and publish, make available,
and disseminate the results of such evaluations
on as wide a basis as is practicable.

Page 1373

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(f) Reports
Not later than 1 year after February 17, 2009,
and annually thereafter, the Secretary shall
submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Finance of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report that—
(1) describes the specific projects established
under this section; and
(2) contains recommendations for Congress
based on the evaluation conducted under subsection (e).
(July 1, 1944, ch. 373, title XXX, § 3015, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 256.)
§ 300jj–36. Information technology professionals
in health care
(a) In general
The Secretary, in consultation with the Director of the National Science Foundation, shall
provide assistance to institutions of higher education (or consortia thereof) to establish or expand medical health informatics education programs, including certification, undergraduate,
and masters degree programs, for both health
care and information technology students to ensure the rapid and effective utilization and development of health information technologies
(in the United States health care infrastructure).
(b) Activities
Activities for which assistance may be provided under subsection (a) may include the following:
(1) Developing and revising curricula in medical health informatics and related disciplines.
(2) Recruiting and retaining students to the
program involved.
(3) Acquiring equipment necessary for student instruction in these programs, including
the installation of testbed networks for student use.
(4) Establishing or enhancing bridge programs in the health informatics fields between
community colleges and universities.
(c) Priority
In providing assistance under subsection (a),
the Secretary shall give preference to the following:
(1) Existing education and training programs.
(2) Programs designed to be completed in
less than six months.
(July 1, 1944, ch. 373, title XXX, § 3016, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 257.)
§ 300jj–37. General grant and loan provisions
(a) Reports
The Secretary may require that an entity receiving assistance under this part shall submit
to the Secretary, not later than the date that is
1 year after the date of receipt of such assistance, a report that includes—
(1) an analysis of the effectiveness of the activities for which the entity receives such as-

§ 300jj–38

sistance, as compared to the goals for such activities; and
(2) an analysis of the impact of the project
on health care quality and safety.
(b) Requirement to improve quality of care and
decrease in costs
The National Coordinator shall annually
evaluate the activities conducted under this
part and shall, in awarding grants, implement
the lessons learned from such evaluation in a
manner so that awards made subsequent to each
such evaluation are made in a manner that, in
the determination of the National Coordinator,
will result in the greatest improvement in the
quality and efficiency of health care.
(July 1, 1944, ch. 373, title XXX, § 3017, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 257.)
§ 300jj–38. Authorization for appropriations
For the purposes of carrying out this part,
there is authorized to be appropriated such sums
as may be necessary for each of the fiscal years
2009 through 2013.
(July 1, 1944, ch. 373, title XXX, § 3018, as added
Pub. L. 111–5, div. A, title XIII, § 13301, Feb. 17,
2009, 123 Stat. 258.)
PRIOR PROVISIONS
A prior section 300aaa, act July 1, 1944, ch. 373, title
XXVII, § 2701, formerly title V, § 501, 58 Stat. 709, as
amended, which related to gifts for benefit of Service,
was renumbered section 231 of title II of act July 1,
1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10,
1993, 107 Stat. 213, and transferred to section 238 of this
title.
A prior section 300aaa–1, act July 1, 1944, ch. 373, title
XXVII, § 2702, formerly title V, § 502, 58 Stat. 710, as
amended, which related to use of immigration station
hospitals, was renumbered section 232 of title II of act
July 1, 1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213, and transferred to section
238a of this title.
A prior section 300aaa–2, act July 1, 1944, ch. 373, title
XXVII, § 2703, formerly title V, § 503, 58 Stat. 710, as
amended, which related to disposition of money collected for care of patients, was renumbered section 233
of title II of act July 1, 1944, by Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213, and transferred to section 238b of this title.
A prior section 300aaa–3, act July 1, 1944, ch. 373, title
XXVII, § 2704, formerly title V, § 506, 58 Stat. 710, as
amended, which related to transportation of remains of
officers, was renumbered section 234 of title II of act
July 1, 1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213, and transferred to section
238c of this title.
A prior section 300aaa–4, act July 1, 1944, ch. 373, title
XXVII, § 2705, formerly title V, § 507, as added June 24,
1967, Pub. L. 90–31, § 5, 81 Stat. 79, and amended, which
related to availability of appropriations for grants to
Federal institutions, was renumbered section 235 of
title II of act July 1, 1944, by Pub. L. 103–43, title XX,
§ 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213, and transferred to section 238d of this title.
A prior section 300aaa–5, act July 1, 1944, ch. 373, title
XXVII, § 2706, formerly title V, § 508, 58 Stat. 711, as
amended, which related to transfer of funds for continuance of transferred functions, was renumbered section 236 of title II of act July 1, 1944, by Pub. L. 103–43,
title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213, and
transferred to section 238e of this title.
A prior section 300aaa–6, act July 1, 1944, ch. 373, title
XXVII, § 2707, formerly title V, § 509, 58 Stat. 711, as

§ 300jj–51

TITLE 42—THE PUBLIC HEALTH AND WELFARE

amended, which related to availability of appropriations, was renumbered section 237 of title II of act July
1, 1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June
10, 1993, 107 Stat. 213, and transferred to section 238f of
this title.
A prior section 300aaa–7, act July 1, 1944, ch. 373, title
XXVII, § 2708, formerly title V, § 510, 58 Stat. 711, as
amended, which related to wearing of uniforms, was renumbered section 238 of title II of act July 1, 1944, by
Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107
Stat. 213, and transferred to section 238g of this title.
A prior section 300aaa–8, act July 1, 1944, ch. 373, title
XXVII, § 2709, formerly title V, § 511, 58 Stat. 711, as
amended, which related to annual report of Surgeon
General, was renumbered section 239 of title II of act
July 1, 1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213, and transferred to section
238h of this title.
A prior section 300aaa–9, act July 1, 1944, ch. 373, title
XXVII, § 2710, formerly title V, § 512, as added Oct. 15,
1968, Pub. L. 90–574, title V, § 503(a), 82 Stat. 1012, and
amended, which related to memorials and other acknowledgements for contributions to the health of the
Nation, was renumbered section 240 of title II of act
July 1, 1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3),
June 10, 1993, 107 Stat. 213, and transferred to section
238i of this title.
A prior section 300aaa–10, act July 1, 1944, ch. 373,
title XXVII, § 2711, formerly title V, § 513, as added June
30, 1970, Pub. L. 91–296, title IV, § 401(a), 84 Stat. 351, and
amended, which related to evaluation of programs, was
renumbered section 241 of title II of act July 1, 1944, by
Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107
Stat. 213, and transferred to section 238j of this title.
A prior section 300aaa–11, act July 1, 1944, ch. 373,
title XXVII, § 2712, formerly title V, § 514, as added Nov.
9, 1978, Pub. L. 95–623, § 11(e), 92 Stat. 3456, and amended,
which related to contract authority, was renumbered
section 242 of title II of act July 1, 1944, by Pub. L.
103–43, title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat.
213, and transferred to section 238k of this title.
A prior section 300aaa–12, act July 1, 1944, ch. 373,
title XXVII, § 2713, formerly title V, § 515, formerly Pub.
L. 88–164, title II, § 225, as added Pub. L. 94–63, title III,
§ 303, July 29, 1975, 89 Stat. 326, and amended, which related to recovery by United States of base amount plus
interest in certain circumstances, was renumbered section 243 of title II of act July 1, 1944, by Pub. L. 103–43,
title XX, § 2010(a)(1)–(3), June 10, 1993, 107 Stat. 213, and
transferred to section 238l of this title.
A prior section 300aaa–13, act July 1, 1944, ch. 373,
title XXVII, § 2714, formerly title XXI, § 2116, as added
Apr. 7, 1986, Pub. L. 99–272, title XVII, § 17003, 100 Stat.
359, and amended, which related to use of fiscal agents,
was renumbered section 244 of title II of act July 1,
1944, by Pub. L. 103–43, title XX, § 2010(a)(1)–(3), June 10,
1993, 107 Stat. 213, and transferred to section 238m of
this title.

PART C—OTHER PROVISIONS
§ 300jj–51. Health information technology enrollment standards and protocols
(a) In general
(1) Standards and protocols
Not later than 180 days after March 23, 2010, 1
the Secretary, in consultation with the HIT
Policy Committee and the HIT Standards
Committee, shall develop interoperable and
secure standards and protocols that facilitate
enrollment of individuals in Federal and State
health and human services programs, as determined by the Secretary.
(2) Methods
The Secretary shall facilitate enrollment in
such programs through methods determined
1 See

References in Text note below.

Page 1374

appropriate by the Secretary, which shall include providing individuals and third parties
authorized by such individuals and their designees notification of eligibility and verification of eligibility required under such programs.
(b) Content
The standards and protocols for electronic enrollment in the Federal and State programs described in subsection (a) shall allow for the following:
(1) Electronic matching against existing
Federal and State data, including vital
records, employment history, enrollment systems, tax records, and other data determined
appropriate by the Secretary to serve as evidence of eligibility and in lieu of paper-based
documentation.
(2) Simplification and submission of electronic documentation, digitization of documents, and systems verification of eligibility.
(3) Reuse of stored eligibility information
(including documentation) to assist with retention of eligible individuals.
(4) Capability for individuals to apply, recertify and manage their eligibility information
online, including at home, at points of service,
and other community-based locations.
(5) Ability to expand the enrollment system
to integrate new programs, rules, and
functionalities, to operate at increased volume, and to apply streamlined verification
and eligibility processes to other Federal and
State programs, as appropriate.
(6) Notification of eligibility, recertification,
and other needed communication regarding
eligibility, which may include communication
via email and cellular phones.
(7) Other functionalities necessary to provide eligibles with streamlined enrollment
process.
(c) Approval and notification
With respect to any standard or protocol developed under subsection (a) that has been approved by the HIT Policy Committee and the
HIT Standards Committee, the Secretary—
(1) shall notify States of such standards or
protocols; and
(2) may require, as a condition of receiving
Federal funds for the health information technology investments, that States or other entities incorporate such standards and protocols
into such investments.
(d) Grants for implementation of appropriate enrollment HIT
(1) In general
The Secretary shall award grant 2 to eligible
entities to develop new, and adapt existing,
technology systems to implement the HIT enrollment standards and protocols developed
under subsection (a) (referred to in this subsection as ‘‘appropriate HIT technology’’).
(2) Eligible entities
To be eligible for a grant under this subsection, an entity shall—
(A) be a State, political subdivision of a
State, or a local governmental entity; and
2 So

in original. Probably should be ‘‘grants’’.

Page 1375

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) submit to the Secretary an application
at such time, in such manner, and containing—
(i) a plan to adopt and implement appropriate enrollment technology that includes—
(I) proposed reduction in maintenance
costs of technology systems;
(II) elimination or updating of legacy
systems; and
(III) demonstrated collaboration with
other entities that may receive a grant
under this section that are located in the
same State, political subdivision, or locality;
(ii) an assurance that the entity will
share such appropriate enrollment technology in accordance with paragraph (4);
and
(iii) such other information as the Secretary may require.
(3) Sharing
(A) In general
The Secretary shall ensure that appropriate enrollment HIT adopted under grants
under this subsection is made available to
other qualified State, qualified political subdivisions of a State, or other appropriate
qualified entities (as described in subparagraph (B)) at no cost.
(B) Qualified entities
The Secretary shall determine what entities are qualified to receive enrollment HIT
under subparagraph (A), taking into consideration the recommendations of the HIT
Policy Committee and the HIT Standards
Committee.
(July 1, 1944, ch. 373, title XXX, § 3021, as added
Pub. L. 111–148, title I, § 1561, Mar. 23, 2010, 124
Stat. 262.)
REFERENCES IN TEXT
March 23, 2010, referred to in subsec. (a)(1), was in the
original ‘‘the date of enactment of this title’’, which
was translated as meaning the date of enactment of
Pub. L. 111–148, which enacted this part, to reflect the
probable intent of Congress.

SUBCHAPTER XXIX—DATA COLLECTION,
ANALYSIS, AND QUALITY
§ 300kk. Data collection, analysis, and quality
(a) Data collection
(1) In general
The Secretary shall ensure that, by not later
than 2 years after March 23, 2010, any federally
conducted or supported health care or public
health program, activity or survey (including
Current Population Surveys and American
Community Surveys conducted by the Bureau
of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
(A) data on race, ethnicity, sex, primary
language, and disability status for applicants, recipients, or participants;
(B) data at the smallest geographic level
such as State, local, or institutional levels if
such data can be aggregated;

§ 300kk

(C) sufficient data to generate statistically
reliable estimates by racial, ethnic, sex, primary language, and disability status subgroups for applicants, recipients or participants using, if needed, statistical oversamples of these subpopulations; and
(D) any other demographic data as deemed
appropriate by the Secretary regarding
health disparities.
(2) Collection standards
In collecting data described in paragraph (1),
the Secretary or designee shall—
(A) use Office of Management and Budget
standards, at a minimum, for race and ethnicity measures;
(B) develop standards for the measurement
of sex, primary language, and disability
status;
(C) develop standards for the collection of
data described in paragraph (1) that, at a
minimum—
(i) collects self-reported data by the applicant, recipient, or participant; and
(ii) collects data from a parent or legal
guardian if the applicant, recipient, or participant is a minor or legally incapacitated;
(D) survey health care providers and establish other procedures in order to assess access to care and treatment for individuals
with disabilities and to identify—
(i) locations where individuals with disabilities access primary, acute (including
intensive), and long-term care;
(ii) the number of providers with accessible facilities and equipment to meet the
needs of the individuals with disabilities,
including medical diagnostic equipment
that meets the minimum technical criteria set forth in section 794f of title 29;
and
(iii) the number of employees of health
care providers trained in disability awareness and patient care of individuals with
disabilities; and
(E) require that any reporting requirement
imposed for purposes of measuring quality
under any ongoing or federally conducted or
supported health care or public health program, activity, or survey includes requirements for the collection of data on individuals receiving health care items or services
under such programs activities 1 by race,
ethnicity, sex, primary language, and disability status.
(3) Data management
In collecting data described in paragraph (1),
the Secretary, acting through the National
Coordinator for Health Information Technology shall—
(A) develop national standards for the
management of data collected; and
(B) develop interoperability and security
systems for data management.
1 So

in original.

§ 300kk

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Data analysis
(1) 2 In general
For each federally conducted or supported
health care or public health program or activity, the Secretary shall analyze data collected
under paragraph (a) to detect and monitor
trends in health disparities (as defined for purposes of section 285t 3 of this title) at the Federal and State levels.
(c) Data reporting and dissemination
(1) In general
The Secretary shall make the analyses described in (b) 4 available to—
(A) the Office of Minority Health;
(B) the National Center on Minority
Health and Health Disparities;
(C) the Agency for Healthcare Research
and Quality;
(D) the Centers for Disease Control and
Prevention;
(E) the Centers for Medicare & Medicaid
Services;
(F) the Indian Health Service and epidemiology centers funded under the Indian
Health Care Improvement Act [25 U.S.C. 1601
et seq.];
(G) the Office of Rural health; 5
(H) other agencies within the Department
of Health and Human Services; and
(I) other entities as determined appropriate by the Secretary.
(2) Reporting of data
The Secretary shall report data and analyses
described in (a) 4 and (b) through—
(A) public postings on the Internet
websites of the Department of Health and
Human Services; and
(B) any other reporting or dissemination
mechanisms determined appropriate by the
Secretary.
(3) Availability of data
The Secretary may make data described in
(a) and (b) available for additional research,
analyses, and dissemination to other Federal
agencies, non-governmental entities, and the
public, in accordance with any Federal agency’s data user agreements.
(d) Limitations on use of data
Nothing in this section shall be construed to
permit the use of information collected under
this section in a manner that would adversely
affect any individual.
(e) Protection and sharing of data
(1) Privacy and other safeguards
The Secretary shall ensure (through the promulgation of regulations or otherwise) that—
(A) all data collected pursuant to subsection (a) is protected—
(i) under privacy protections that are at
least as broad as those that the Secretary
applies to other health data under the regulations promulgated under section 264(c)
2 So

in original. No par. (2) has been enacted.
References in Text note below.
4 So in original. Probably should be preceded by ‘‘subsection’’.
5 So in original. Probably should be ‘‘Health;’’.
3 See

Page 1376

of the Health Insurance Portability and
Accountability Act of 1996 (Public Law
104–191; 110 Stat. 2033); and
(ii) from all inappropriate internal use
by any entity that collects, stores, or receives the data, including use of such data
in determinations of eligibility (or continued eligibility) in health plans, and
from other inappropriate uses, as defined
by the Secretary; and
(B) all appropriate information security
safeguards are used in the collection, analysis, and sharing of data collected pursuant to
subsection (a).
(2) Data sharing
The Secretary shall establish procedures for
sharing data collected pursuant to subsection
(a), measures relating to such data, and analyses of such data, with other relevant Federal
and State agencies including the agencies,
centers, and entities within the Department of
Health and Human Services specified in subsection (c)(1)..1
(f) Data on rural underserved populations
The Secretary shall ensure that any data collected in accordance with this section regarding
racial and ethnic minority groups are also collected regarding underserved rural and frontier
populations.
(g) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2010 through 2014.
(h) Requirement for implementation
Notwithstanding any other provision of this
section, data may not be collected under this
section unless funds are directly appropriated
for such purpose in an appropriations Act.
(i) Consultation
The Secretary shall consult with the Director
of the Office of Personnel Management, the Secretary of Defense, the Secretary of Veterans Affairs, the Director of the Bureau of the Census,
the Commissioner of Social Security, and the
head of other appropriate Federal agencies in
carrying out this section.
(July 1, 1944, ch. 373, title XXXI, § 3101, as added
Pub. L. 111–148, title IV, § 4302(a), Mar. 23, 2010,
124 Stat. 578.)
REFERENCES IN TEXT
Section 285t of this title, referred to in subsec. (b)(1),
was in the original ‘‘section 485E’’, meaning section
485E of act July 1, 1944, which was renumbered section
464z–3 by Pub. L. 111–148, title X, § 10334(c)(1)(D)(i), Mar.
23, 2010, 124 Stat. 973, and is classified to section 285t of
this title. The act of July 1, 1944, no longer contains a
section 485E.
The Indian Health Care Improvement Act, referred to
in subsec. (c)(1)(F), is Pub. L. 94–437, Sept. 30, 1976, 90
Stat. 1400, which is classified principally to chapter 18
(§ 1601 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note
set out under section 1601 of Title 25 and Tables.
Section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104–191; 110 Stat.
2033), referred to in subsec. (e)(1)(A)(i), is set out as a
note under section 1320d–2 of this title.

Page 1377

TITLE 42—THE PUBLIC HEALTH AND WELFARE

SUBCHAPTER XXX—COMMUNITY LIVING
ASSISTANCE SERVICES AND SUPPORTS
§ 300ll. Purpose
The purpose of this subchapter is to establish
a national voluntary insurance program for purchasing community living assistance services
and supports in order to—
(1) provide individuals with functional limitations with tools that will allow them to
maintain their personal and financial independence and live in the community through a
new financing strategy for community living
assistance services and supports;
(2) establish an infrastructure that will help
address the Nation’s community living assistance services and supports needs;
(3) alleviate burdens on family caregivers;
and
(4) address institutional bias by providing a
financing mechanism that supports personal
choice and independence to live in the community.
(July 1, 1944, ch. 373, title XXXII, § 3201, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 828.)
EFFECTIVE DATE
Pub. L. 111–148, title VIII, § 8002(e), Mar. 23, 2010, 124
Stat. 847, provided that: ‘‘The amendments made by
subsections (a), (b), and (d) [enacting this subchapter,
amending section 1396a of this title, and amending provisions set out as a note under section 1396p of this
title] take effect on January 1, 2011.’’
CONSTRUCTION
Pub. L. 111–148, title VIII, § 8002(f), Mar. 23, 2010, 124
Stat. 847, provided that: ‘‘Nothing in this title [enacting this subchapter, amending section 1396a of this
title, enacting provisions set out as notes under this
section and section 201 of this title, and amending provisions set out as a note under section 1396p of this
title] or the amendments made by this title are [sic] intended to replace or displace public or private disability insurance benefits, including such benefits that are
for income replacement.’’
PERSONAL CARE ATTENDANTS WORKFORCE ADVISORY
PANEL
Pub. L. 111–148, title VIII, § 8002(c), Mar. 23, 2010, 124
Stat. 846, provided that:
‘‘(1) ESTABLISHMENT.—Not later than 90 days after the
date of enactment of this Act [Mar. 23, 2010], the Secretary of Health and Human Services shall establish a
Personal Care Attendants Workforce Advisory Panel
for the purpose of examining and advising the Secretary and Congress on workforce issues related to personal care attendant workers, including with respect to
the adequacy of the number of such workers, the salaries, wages, and benefits of such workers, and access to
the services provided by such workers.
‘‘(2) MEMBERSHIP.—In appointing members to the Personal Care Attendants Workforce Advisory Panel, the
Secretary shall ensure that such members include the
following:
‘‘(A) Individuals with disabilities of all ages.
‘‘(B) Senior individuals.
‘‘(C) Representatives of individuals with disabilities.
‘‘(D) Representatives of senior individuals.
‘‘(E) Representatives of workforce and labor organizations.
‘‘(F) Representatives of home and community-based
service providers.
‘‘(G) Representatives of assisted living providers.’’

§ 300ll–1

§ 300ll–1. Definitions
In this subchapter:
(1) Active enrollee
The term ‘‘active enrollee’’ means an individual who is enrolled in the CLASS program
in accordance with section 300ll–3 of this title
and who has paid any premiums due to maintain such enrollment.
(2) Actively employed
The term ‘‘actively employed’’ means an individual who—
(A) is reporting for work at the individual’s usual place of employment or at another location to which the individual is required to travel because of the individual’s
employment (or in the case of an individual
who is a member of the uniformed services,
is on active duty and is physically able to
perform the duties of the individual’s position); and
(B) is able to perform all the usual and
customary duties of the individual’s employment on the individual’s regular work schedule.
(3) Activities of daily living
The term ‘‘activities of daily living’’ means
each of the following activities specified in
section 7702B(c)(2)(B) of title 26:
(A) Eating.
(B) Toileting.
(C) Transferring.
(D) Bathing.
(E) Dressing.
(F) Continence.
(4) CLASS program
The term ‘‘CLASS program’’ means the program established under this subchapter.
(5) Eligibility Assessment System
The term ‘‘Eligibility Assessment System’’
means the entity established by the Secretary
under section 300ll–4(a)(2) of this title to make
functional eligibility determinations for the
CLASS program.
(6) Eligible beneficiary
(A) In general
The term ‘‘eligible beneficiary’’ means any
individual who is an active enrollee in the
CLASS program and, as of the date described in subparagraph (B)—
(i) has paid premiums for enrollment in
such program for at least 60 months;
(ii) has earned, with respect to at least 3
calendar years that occur during the first
60 months for which the individual has
paid premiums for enrollment in the program, at least an amount equal to the
amount of wages and self-employment income which an individual must have in
order to be credited with a quarter of coverage under section 213(d) of the Social Security Act [42 U.S.C. 413(d)] for the year;
and
(iii) has paid premiums for enrollment in
such program for at least 24 consecutive
months, if a lapse in premium payments of
more than 3 months has occurred during

§ 300ll–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

the period that begins on the date of the
individual’s enrollment and ends on the
date of such determination.
(B) Date described
For purposes of subparagraph (A), the date
described in this subparagraph is the date on
which the individual is determined to have a
functional limitation described in section
300ll–2(a)(1)(C) of this title that is expected
to last for a continuous period of more than
90 days.
(C) Regulations
The Secretary shall promulgate regulations specifying exceptions to the minimum
earnings requirements under subparagraph
(A)(ii) for purposes of being considered an eligible beneficiary for certain populations.
(7) Hospital; nursing facility; intermediate care
facility for the mentally retarded; institution for mental diseases
The terms ‘‘hospital’’, ‘‘nursing facility’’,
‘‘intermediate care facility for the mentally
retarded’’, and ‘‘institution for mental diseases’’ have the meanings given such terms for
purposes of Medicaid.
(8) CLASS Independence Advisory Council
The term ‘‘CLASS Independence Advisory
Council’’ or ‘‘Council’’ means the Advisory
Council established under section 300ll–6 of
this title to advise the Secretary.
(9) CLASS Independence Benefit Plan
The term ‘‘CLASS Independence Benefit
Plan’’ means the benefit plan developed and
designated by the Secretary in accordance
with section 300ll–2 of this title.
(10) CLASS Independence Fund
The term ‘‘CLASS Independence Fund’’ or
‘‘Fund’’ means the fund established under section 300ll–5 of this title.
(11) Medicaid
The term ‘‘Medicaid’’ means the program established under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.).
(12) Poverty line
The term ‘‘poverty line’’ has the meaning
given that term in section 2110(c)(5) of the Social Security Act (42 U.S.C. 1397jj(c)(5)).
(13) Protection and Advocacy System
The term ‘‘Protection and Advocacy System’’ means the system for each State established under section 15043 of this title.
(July 1, 1944, ch. 373, title XXXII, § 3202, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 828.)
REFERENCES IN TEXT
The Social Security Act, referred to in par. (11), is act
Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XIX of the Act
is classified generally to subchapter XIX (§ 1396 et seq.)
of chapter 7 of this title. For complete classification of
this Act to the Code, see section 1305 of this title and
Tables.

§ 300ll–2. CLASS Independence Benefit Plan
(a) Process for development
(1) In general
The Secretary, in consultation with appropriate actuaries and other experts, shall de-

Page 1378

velop at least 3 actuarially sound benefit plans
as alternatives for consideration for designation by the Secretary as the CLASS Independence Benefit Plan under which eligible beneficiaries shall receive benefits under this subchapter. Each of the plan alternatives developed shall be designed to provide eligible beneficiaries with the benefits described in section
300ll–4 of this title consistent with the following requirements:
(A) Premiums
(i) In general
Beginning with the first year of the
CLASS program, and for each year thereafter, subject to clauses (ii) and (iii), the
Secretary shall establish all premiums to
be paid by enrollees for the year based on
an actuarial analysis of the 75-year costs
of the program that ensures solvency
throughout such 75-year period.
(ii) Nominal premium for poorest individuals and full-time students
(I) In general
The monthly premium for enrollment
in the CLASS program shall not exceed
the applicable dollar amount per month
determined under subclause (II) for—
(aa) any individual whose income
does not exceed the poverty line; and
(bb) any individual who has not attained age 22, and is actively employed
during any period in which the individual is a full-time student (as determined by the Secretary).
(II) Applicable dollar amount
The applicable dollar amount described
in this subclause is the amount equal to
$5, increased by the percentage increase
in the consumer price index for all urban
consumers (U.S. city average) for each
year occurring after 2009 and before such
year.
(iii) CLASS Independence Fund reserves
At such time as the CLASS program has
been in operation for 10 years, the Secretary shall establish all premiums to be
paid by enrollees for the year based on an
actuarial analysis that accumulated reserves in the CLASS Independence Fund
would not decrease in that year. At such
time as the Secretary determines the
CLASS program demonstrates a sustained
ability to finance expected yearly expenses
with expected yearly premiums and interest credited to the CLASS Independence
Fund, the Secretary may decrease the required amount of CLASS Independence
Fund reserves.
(B) Vesting period
A 5-year vesting period for eligibility for
benefits.
(C) Benefit triggers
A benefit trigger for provision of benefits
that requires a determination that an individual has a functional limitation, as certified by a licensed health care practitioner,

Page 1379

TITLE 42—THE PUBLIC HEALTH AND WELFARE

described in any of the following clauses
that is expected to last for a continuous period of more than 90 days:
(i) The individual is determined to be unable to perform at least the minimum
number (which may be 2 or 3) of activities
of daily living as are required under the
plan for the provision of benefits without
substantial assistance (as defined by the
Secretary) from another individual.
(ii) The individual requires substantial
supervision to protect the individual from
threats to health and safety due to substantial cognitive impairment.
(iii) The individual has a level of functional limitation similar (as determined
under regulations prescribed by the Secretary) to the level of functional limitation described in clause (i) or (ii).
(D) Cash benefit
Payment of a cash benefit that satisfies
the following requirements:
(i) Minimum required amount
The benefit amount provides an eligible
beneficiary with not less than an average
of $50 per day (as determined based on the
reasonably expected distribution of beneficiaries receiving benefits at various benefit levels).
(ii) Amount scaled to functional ability
The benefit amount is varied based on a
scale of functional ability, with not less
than 2, and not more than 6, benefit level
amounts.
(iii) Daily or weekly
The benefit is paid on a daily or weekly
basis.
(iv) No lifetime or aggregate limit
The benefit is not subject to any lifetime
or aggregate limit.
(2) Review and recommendation by the CLASS
Independence Advisory Council
The CLASS Independence Advisory Council
shall—
(A) evaluate the alternative benefit plans
developed under paragraph (1); and
(B) recommend for designation as the
CLASS Independence Benefit Plan for offering to the public the plan that the Council
determines best balances price and benefits
to meet enrollees’ needs in an actuarially
sound manner, while optimizing the probability of the long-term sustainability of the
CLASS program.
(3) Designation by the Secretary
Not later than October 1, 2012, the Secretary,
taking into consideration the recommendation
of the CLASS Independence Advisory Council
under paragraph (2)(B), shall designate a benefit plan as the CLASS Independence Benefit
Plan. The Secretary shall publish such designation, along with details of the plan and
the reasons for the selection by the Secretary,
in a final rule that allows for a period of public comment.

§ 300ll–2

(b) Additional premium requirements
(1) Adjustment of premiums
(A) In general
Except as provided in subparagraphs (B),
(C), (D), and (E), the amount of the monthly
premium determined for an individual upon
such individual’s enrollment in the CLASS
program shall remain the same for as long
as the individual is an active enrollee in the
program.
(B) Recalculated premium if required for
program solvency
(i) In general
Subject to clause (ii), if the Secretary
determines, based on the most recent report of the Board of Trustees of the CLASS
Independence Fund, the advice of the
CLASS Independence Advisory Council,
and the annual report of the Inspector
General of the Department of Health and
Human Services, and waste, fraud, and
abuse, or such other information as the
Secretary determines appropriate, that
the monthly premiums and income to the
CLASS Independence Fund for a year are
projected to be insufficient with respect to
the 20-year period that begins with that
year, the Secretary shall adjust the
monthly premiums for individuals enrolled
in the CLASS program as necessary (but
maintaining a nominal premium for enrollees whose income is below the poverty
line or who are full-time students actively
employed).
(ii) Exemption from increase
Any increase in a monthly premium imposed as result of a determination described in clause (i) shall not apply with
respect to the monthly premium of any active enrollee who—
(I) has attained age 65;
(II) has paid premiums for enrollment
in the program for at least 20 years; and
(III) is not actively employed.
(C) Recalculated premium if reenrollment
after more than a 3-month lapse
(i) In general
The reenrollment of an individual after a
90-day period during which the individual
failed to pay the monthly premium required to maintain the individual’s enrollment in the CLASS program shall be
treated as an initial enrollment for purposes of age-adjusting the premium for reenrollment in the program.
(ii) Credit for prior months if reenrolled
within 5 years
An individual who reenrolls in the
CLASS program after such a 90-day period
and before the end of the 5-year period
that begins with the first month for which
the individual failed to pay the monthly
premium required to maintain the individual’s enrollment in the program shall be—
(I) credited with any months of paid
premiums that accrued prior to the individual’s lapse in enrollment; and

§ 300ll–3

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(II) notwithstanding the total amount
of any such credited months, required to
satisfy section 300ll–1(6)(A)(ii) of this
title before being eligible to receive benefits.
(D) No longer status as a full-time student
An individual subject to a nominal premium on the basis of being described in subsection (a)(1)(A)(ii)(I)(bb) who ceases to be
described in that subsection, beginning with
the first month following the month in
which the individual ceases to be so described, shall be subject to the same monthly premium as the monthly premium that
applies to an individual of the same age who
first enrolls in the program under the most
similar circumstances as the individual
(such as the first year of eligibility for enrollment in the program or in a subsequent
year).
(E) Penalty for reenollment after 5-year lapse
In the case of an individual who reenrolls
in the CLASS program after the end of the
5-year period described in subparagraph
(C)(ii), the monthly premium required for
the individual shall be the age-adjusted premium that would be applicable to an initially enrolling individual who is the same
age as the reenrolling individual, increased
by the greater of—
(i) an amount that the Secretary determines is actuarially sound for each month
that occurs during the period that begins
with the first month for which the individual failed to pay the monthly premium required to maintain the individual’s enrollment in the CLASS program and ends with
the month preceding the month in which
the reenollment is effective; or
(ii) 1 percent of the applicable age-adjusted premium for each such month occurring in such period.
(2) Administrative expenses
In determining the monthly premiums for
the CLASS program the Secretary may factor
in costs for administering the program, not to
exceed for any year in which the program is in
effect under this subchapter, an amount equal
to 3 percent of all premiums paid during the
year.
(3) No underwriting requirements
No underwriting (other than on the basis of
age in accordance with subparagraphs (D) and
(E) of paragraph (1)) shall be used to—
(A) determine the monthly premium for
enrollment in the CLASS program; or
(B) prevent an individual from enrolling in
the program.
(c) Self-attestation and verification of income
The Secretary shall establish procedures to—
(1) permit an individual who is eligible for
the nominal premium required under subsection (a)(1)(A)(ii) to self-attest that their income does not exceed the poverty line or that
their status as a full-time student who is actively employed; 1
1 So

in original.

Page 1380

(2) verify, using procedures similar to the
procedures used by the Commissioner of Social
Security under section 1383(e)(1)(B)(ii) of this
title and consistent with the requirements applicable to the conveyance of data and information under section 1396w–2 of this title, the
validity of such self-attestation; and
(3) require an individual to confirm, on at
least an annual basis, that their income does
not exceed the poverty line or that they continue to maintain such status.
(July 1, 1944, ch. 373, title XXXII, § 3203, as added
and amended Pub. L. 111–148, title VIII,
§ 8002(a)(1), title X, § 10801(a)(1), Mar. 23, 2010, 124
Stat. 830, 1015.)
AMENDMENTS
2010—Subsec. (a)(1)(E). Pub. L. 111–148, § 10801(a)(1)(A),
struck out subpar. (E). Text read as follows: ‘‘The benefits allow for coordination with any supplemental coverage purchased through an Exchange established
under section 18031 of this title.’’
Subsec. (b)(1)(C)(i). Pub. L. 111–148, § 10801(a)(1)(B),
substituted ‘‘for reenrollment’’ for ‘‘for enrollment’’.
Subsec. (c)(1). Pub. L. 111–148, § 10801(a)(1)(C), struck
out ‘‘, as part of their automatic enrollment in the
CLASS program,’’ after ‘‘subsection (a)(1)(A)(ii)’’.

§ 300ll–3. Enrollment and disenrollment requirements
(a) Automatic enrollment
(1) In general
Subject to paragraph (2), the Secretary, in
coordination with the Secretary of the Treasury, shall establish procedures under which
each individual described in subsection (c)
may be automatically enrolled in the CLASS
program by an employer of such individual in
the same manner as an employer may elect to
automatically enroll employees in a plan
under section 401(k), 403(b), or 457 of title 26.
(2) Alternative enrollment procedures
The procedures established under paragraph
(1) shall provide for an alternative enrollment
process for an individual described in subsection (c) in the case of such an individual—
(A) who is self-employed;
(B) who has more than 1 employer; or
(C) whose employer does not elect to participate in the automatic enrollment process
established by the Secretary.
(3) Administration
(A) In general
The Secretary and the Secretary of the
Treasury shall, by regulation, establish procedures to ensure that an individual is not
automatically enrolled in the CLASS program by more than 1 employer.
(B) Form
Enrollment in the CLASS program shall
be made in such manner as the Secretary
may prescribe in order to ensure ease of administration.
(b) Election to opt-out
An individual described in subsection (c) may
elect to waive enrollment in the CLASS program at any time in such form and manner as
the Secretary and the Secretary of the Treasury
shall prescribe.

Page 1381

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(c) Individual described
For purposes of enrolling in the CLASS program, an individual described in this paragraph
is an individual—
(1) who has attained age 18;
(2) who—
(A) receives wages or income on which
there is imposed a tax under section 3101(a)
or 3201(a) of title 26; or
(B) derives self-employment income on
which there is imposed a tax under section
1401(a) of title 26;
(3) who is actively employed; and
(4) who is not—
(A) a patient in a hospital or nursing facility, an intermediate care facility for the
mentally retarded, or an institution for
mental diseases and receiving medical assistance under Medicaid; or
(B) confined in a jail, prison, other penal
institution or correctional facility, or by
court order pursuant to conviction of a
criminal offense or in connection with a verdict or finding described in section
402(x)(1)(A)(ii) of this title.
(d) Rule of construction
Nothing in this subchapter shall be construed
as requiring an active enrollee to continue to
satisfy subparagraph (A) or (B) of subsection
(c)(2) in order to maintain enrollment in the
CLASS program.
(e) Payment
(1) Payroll deduction
An amount equal to the monthly premium
for the enrollment in the CLASS program of
an individual shall be deducted from the wages
or self-employment income of such individual
in accordance with such procedures as the Secretary, in coordination with the Secretary of
the Treasury, shall establish for employers
who elect to deduct and withhold such premiums on behalf of enrolled employees.
(2) Alternative payment mechanism
The Secretary, in coordination with the Secretary of the Treasury, shall establish alternative procedures for the payment of monthly
premiums by an individual enrolled in the
CLASS program—
(A) who does not have an employer who
elects to deduct and withhold premiums in
accordance with paragraph (1); or
(B) who does not earn wages or derive selfemployment income.
(f) Transfer of premiums collected
(1) In general
During each calendar year the Secretary of
the Treasury shall deposit into the CLASS
Independence Fund a total amount equal, in
the aggregate, to 100 percent of the premiums
collected during that year.
(2) Transfers based on estimates
The amount deposited pursuant to paragraph (1) shall be transferred in at least
monthly payments to the CLASS Independence Fund on the basis of estimates by the
Secretary and certified to the Secretary of the

§ 300ll–4

Treasury of the amounts collected in accordance with subparagraphs (A) and (B) of paragraph (5).1 Proper adjustments shall be made
in amounts subsequently transferred to the
Fund to the extent prior estimates were in excess of, or were less than, actual amounts collected.
(g) Other enrollment and disenrollment opportunities
The Secretary, in coordination with the Secretary of the Treasury, shall establish procedures under which—
(1) an individual who, in the year of the individual’s initial eligibility to enroll in the
CLASS program, has not enrolled in the program, is eligible to elect to enroll in the program, in such form and manner as the Secretaries shall establish, only during an open
enrollment period established by the Secretaries that is specific to the individual and that
may not occur more frequently than biennially after the date on which the individual
first elected to waive enrollment in the program; and
(2) an individual shall only be permitted to
disenroll from the program (other than for
nonpayment of premiums) during an annual
disenrollment period established by the Secretaries and in such form and manner as the
Secretaries shall establish.
(July 1, 1944, ch. 373, title XXXII, § 3204, as added
and amended Pub. L. 111–148, title VIII,
§ 8002(a)(1), title X, § 10801(a)(2), Mar. 23, 2010, 124
Stat. 834, 1015.)
AMENDMENTS
2010—Subsec. (c)(2)(A). Pub. L. 111–148, § 10801(a)(2)(A),
added subpar. (A) and struck out former subpar. (A)
which read as follows: ‘‘receives wages on which there
is imposed a tax under section 3201(a) of title 26; or’’.
Subsec. (d). Pub. L. 111–148, § 10801(a)(2)(B), substituted ‘‘subparagraph (A) or (B) of subsection (c)(2)’’
for ‘‘subparagraph (B) or (C) of subsection (c)(1)’’.
Subsec. (e)(2)(A). Pub. L. 111–148, § 10801(a)(2)(C), substituted ‘‘paragraph (1)’’ for ‘‘subparagraph (A)’’.
Subsec. (g)(1). Pub. L. 111–148, § 10801(a)(2)(D), substituted ‘‘has not enrolled’’ for ‘‘has elected to waive
enrollment’’.

§ 300ll–4. Benefits
(a) Determination of eligibility
(1) Application for receipt of benefits
The Secretary shall establish procedures
under which an active enrollee shall apply for
receipt of benefits under the CLASS Independence Benefit Plan.
(2) Eligibility assessments
(A) In general
Not later than January 1, 2012, the Secretary shall—
(i) establish an Eligibility Assessment
System (other than a service with which
the Commissioner of Social Security has
entered into an agreement, with respect to
any State, to make disability determinations for purposes of title II or XVI of the
Social Security Act [42 U.S.C. 401 et seq.,
1 So

in original. No par. (5) has been enacted.

§ 300ll–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1381 et seq.]) to provide for eligibility assessments of active enrollees who apply for
receipt of benefits;
(ii) enter into an agreement with the
Protection and Advocacy System for each
State to provide advocacy services in accordance with subsection (d); and
(iii) enter into an agreement with public
and private entities to provide advice and
assistance counseling in accordance with
subsection (e).
(B) Regulations
The Secretary shall promulgate regulations to develop an expedited nationally
equitable eligibility determination process,
as certified by a licensed health care practitioner, an appeals process, and a redetermination process, as certified by a licensed
health care practitioner, including whether
an active enrollee is eligible for a cash benefit under the program and if so, the amount
of the cash benefit (in accordance 1 the sliding scale established under the plan).
(C) Presumptive eligibility for certain institutionalized enrollees planning to discharge
An active enrollee shall be deemed presumptively eligible if the enrollee—
(i) has applied for, and attests is eligible
for, the maximum cash benefit available
under the sliding scale established under
the CLASS Independence Benefit Plan;
(ii) is a patient in a hospital (but only if
the hospitalization is for long-term care),
nursing facility, intermediate care facility
for the mentally retarded, or an institution for mental diseases; and
(iii) is in the process of, or about to
begin the process of, planning to discharge
from the hospital, facility, or institution,
or within 60 days from the date of discharge from the hospital, facility, or institution.
(D) Appeals
The Secretary shall establish procedures
under which an applicant for benefits under
the CLASS Independence Benefit Plan shall
be guaranteed the right to appeal an adverse
determination.
(b) Benefits
An eligible beneficiary shall receive the following benefits under the CLASS Independence
Benefit Plan:
(1) Cash benefit
A cash benefit established by the Secretary
in accordance with the requirements of section 300ll–2(a)(1)(D) of this title that—
(A) the first year in which beneficiaries receive the benefits under the plan, is not less
than the average dollar amount specified in
clause (i) of such section; and
(B) for any subsequent year, is not less
than the average per day dollar limit applicable under this subparagraph for the preceding year, increased by the percentage increase in the consumer price index for all
1 So

in original. Probably should be followed by ‘‘with’’.

Page 1382

urban consumers (U.S. city average) over
the previous year.
(2) Advocacy services
Advocacy services in accordance with subsection (d).
(3) Advice and assistance counseling
Advice and assistance counseling in accordance with subsection (e).
(4) Administrative expenses
Advocacy services and advise and assistance
counseling services under paragraphs (2) and
(3) of this subsection shall be included as administrative
expenses
under
section
300ll–2(b)(2) 2 of this title.
(c) Payment of benefits
(1) Life independence account
(A) In general
The Secretary shall establish procedures
for administering the provision of benefits
to eligible beneficiaries under the CLASS
Independence Benefit Plan, including the
payment of the cash benefit for the beneficiary into a Life Independence Account established by the Secretary on behalf of each
eligible beneficiary.
(B) Use of cash benefits
Cash benefits paid into a Life Independence Account of an eligible beneficiary shall
be used to purchase nonmedical services and
supports that the beneficiary needs to maintain his or her independence at home or in
another residential setting of their choice in
the community, including (but not limited
to) home modifications, assistive technology, accessible transportation, homemaker services, respite care, personal assistance services, home care aides, and nursing
support. Nothing in the preceding sentence
shall prevent an eligible beneficiary from
using cash benefits paid into a Life Independence Account for obtaining assistance
with decision making concerning medical
care, including the right to accept or refuse
medical or surgical treatment and the right
to formulate advance directives or other
written instructions recognized under State
law, such as a living will or durable power of
attorney for health care, in the case that an
injury or illness causes the individual to be
unable to make health care decisions.
(C) Electronic management of funds
The Secretary shall establish procedures
for—
(i) crediting an account established on
behalf of a beneficiary with the beneficiary’s cash daily benefit;
(ii) allowing the beneficiary to access
such account through debit cards; and
(iii) accounting for withdrawals by the
beneficiary from such account.
(D) Primary payor rules for beneficiaries
who are enrolled in Medicaid
In the case of an eligible beneficiary who
is enrolled in Medicaid, the following payment rules shall apply:
2 See

References in Text note below.

Page 1383

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(i) Institutionalized beneficiary
If the beneficiary is a patient in a hospital, nursing facility, intermediate care
facility for the mentally retarded, or an
institution for mental diseases, the beneficiary shall retain an amount equal to 5
percent of the beneficiary’s daily or weekly cash benefit (as applicable) (which shall
be in addition to the amount of the beneficiary’s personal needs allowance provided
under Medicaid), and the remainder of
such benefit shall be applied toward the facility’s cost of providing the beneficiary’s
care, and Medicaid shall provide secondary
coverage for such care.
(ii) Beneficiaries receiving home and community-based services
(I) 50 percent of benefit retained by beneficiary
Subject to subclause (II), if a beneficiary is receiving medical assistance
under Medicaid for home and community
based services, the beneficiary shall retain an amount equal to 50 percent of the
beneficiary’s daily or weekly cash benefit (as applicable), and the remainder of
the daily or weekly cash benefit shall be
applied toward the cost to the State of
providing such assistance (and shall not
be used to claim Federal matching funds
under Medicaid), and Medicaid shall provide secondary coverage for the remainder of any costs incurred in providing
such assistance.
(II) Requirement for State offset
A State shall be paid the remainder of
a beneficiary’s daily or weekly cash benefit under subclause (I) only if the State
home and community-based waiver
under section 1115 of the Social Security
Act (42 U.S.C. 1315) or subsection (c) or
(d) of section 1915 of such Act (42 U.S.C.
1396n), or the State plan amendment
under subsection (i) of such section does
not include a waiver of the requirements
of section 1902(a)(1) of the Social Security Act [42 U.S.C. 1396a(a)(1)] (relating
to
statewideness)
or
of
section
1902(a)(10)(B) of such Act [42 U.S.C.
1396a(a)(10)(B)] (relating to comparability) and the State offers at a minimum
case management services, personal care
services, habilitation services, and respite care under such a waiver or State
plan amendment.
(III) Definition of home and communitybased services
In this clause, the term ‘‘home and
community-based services’’ means any
services which may be offered under a
home and community-based waiver authorized for a State under section 1115 of
the Social Security Act (42 U.S.C. 1315)
or subsection (c) or (d) of section 1915 of
such Act (42 U.S.C. 1396n) or under a
State plan amendment under subsection
(i) of such section.

§ 300ll–4

(iii) Beneficiaries enrolled in programs of
all-inclusive care for the elderly
(PACE)
(I) In general
Subject to subclause (II), if a beneficiary is receiving medical assistance
under Medicaid for PACE program services under section 1934 of the Social Security Act (42 U.S.C. 1396u–4), the beneficiary shall retain an amount equal to
50 percent of the beneficiary’s daily or
weekly cash benefit (as applicable), and
the remainder of the daily or weekly
cash benefit shall be applied toward the
cost to the State of providing such assistance (and shall not be used to claim
Federal matching funds under Medicaid),
and Medicaid shall provide secondary
coverage for the remainder of any costs
incurred in providing such assistance.
(II) Institutionalized recipients of PACE
program services
If a beneficiary receiving assistance
under Medicaid for PACE program services is a patient in a hospital, nursing facility, intermediate care facility for the
mentally retarded, or an institution for
mental diseases, the beneficiary shall be
treated as in 3 institutionalized beneficiary under clause (i).
(2) Authorized representatives
(A) In general
The Secretary shall establish procedures
to allow access to a beneficiary’s cash benefits by an authorized representative of the
eligible beneficiary on whose behalf such
benefits are paid.
(B) Quality assurance and protection against
fraud and abuse
The procedures established under subparagraph (A) shall ensure that authorized representatives of eligible beneficiaries comply
with standards of conduct established by the
Secretary, including standards requiring
that such representatives provide quality
services on behalf of such beneficiaries, do
not have conflicts of interest, and do not
misuse benefits paid on behalf of such beneficiaries or otherwise engage in fraud or
abuse.
(3) Commencement of benefits
Benefits shall be paid to, or on behalf of, an
eligible beneficiary beginning with the first
month in which an application for such benefits is approved.
(4) Rollover option for lump-sum payment
An eligible beneficiary may elect to—
(A) defer payment of their daily or weekly
benefit and to rollover any such deferred
benefits from month-to-month, but not from
year-to-year; and
(B) receive a lump-sum payment of such
deferred benefits in an amount that may not
exceed the lesser of—
(i) the total amount of the accrued deferred benefits; or
3 So

in original. Probably should be ‘‘an’’.

§ 300ll–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) the applicable annual benefit.
(5) Period for determination of annual benefits
(A) In general
The applicable period for determining with
respect to an eligible beneficiary the applicable annual benefit and the amount of any
accrued deferred benefits is the 12-month period that commences with the first month in
which the beneficiary began to receive such
benefits, and each 12-month period thereafter.
(B) Inclusion of increased benefits
The Secretary shall establish procedures
under which cash benefits paid to an eligible
beneficiary that increase or decrease as a result of a change in the functional status of
the beneficiary before the end of a 12-month
benefit period shall be included in the determination of the applicable annual benefit
paid to the eligible beneficiary.
(C) Recoupment of unpaid, accrued benefits
(i) In general
The Secretary, in coordination with the
Secretary of the Treasury, shall recoup
any accrued benefits in the event of—
(I) the death of a beneficiary; or
(II) the failure of a beneficiary to elect
under paragraph (4)(B) to receive such
benefits as a lump-sum payment before
the end of the 12-month period in which
such benefits accrued.
(ii) Payment into CLASS Independence
Fund
Any benefits recouped in accordance
with clause (i) shall be paid into the
CLASS Independence Fund and used in accordance with section 300ll–5 of this title.
(6) Requirement to recertify eligibility for receipt of benefits
An eligible beneficiary shall periodically, as
determined by the Secretary—
(A) recertify by submission of medical evidence the beneficiary’s continued eligibility
for receipt of benefits; and
(B) submit records of expenditures attributable to the aggregate cash benefit received
by the beneficiary during the preceding
year.
(7) Supplement, not supplant other health care
benefits
Subject to the Medicaid payment rules
under paragraph (1)(D), benefits received by an
eligible beneficiary shall supplement, but not
supplant, other health care benefits for which
the beneficiary is eligible under Medicaid or
any other Federally funded program that provides health care benefits or assistance.
(d) Advocacy services
An agreement entered into under subsection
(a)(2)(A)(ii) shall require the Protection and Advocacy System for the State to—
(1) assign, as needed, an advocacy counselor
to each eligible beneficiary that is covered by
such agreement and who shall provide an eligible beneficiary with—
(A) information regarding how to access
the appeals process established for the program;

Page 1384

(B) assistance with respect to the annual
recertification and notification required
under subsection (c)(6); and
(C) such other assistance with obtaining
services as the Secretary, by regulation,
shall require; and
(2) ensure that the System and such counselors comply with the requirements of subsection (h).
(e) Advice and assistance counseling
An agreement entered into under subsection
(a)(2)(A)(iii) shall require the entity to assign, as
requested by an eligible beneficiary that is covered by such agreement, an advice and assistance counselor who shall provide an eligible beneficiary with information regarding—
(1) accessing and coordinating long-term
services and supports in the most integrated
setting;
(2) possible eligibility for other benefits and
services;
(3) development of a service and support
plan;
(4) information about programs established
under the Assistive Technology Act of 1998 [29
U.S.C. 3001 et seq.] and the services offered
under such programs;
(5) available assistance with decision making concerning medical care, including the
right to accept or refuse medical or surgical
treatment and the right to formulate advance
directives or other written instructions recognized under State law, such as a living will or
durable power of attorney for health care, in
the case that an injury or illness causes the
individual to be unable to make health care
decisions; and
(6) such other services as the Secretary, by
regulation, may require.
(f) No effect on eligibility for other benefits
Benefits paid to an eligible beneficiary under
the CLASS program shall be disregarded for purposes of determining or continuing the beneficiary’s eligibility for receipt of benefits under
any other Federal, State, or locally funded assistance program, including benefits paid under
titles 4 II, XVI, XVIII, XIX, or XXI of the Social
Security Act (42 U.S.C. 401 et seq., 1381 et seq.,
1395 et seq., 1396 et seq., 1397aa et seq.), under
the laws administered by the Secretary of Veterans Affairs, under low-income housing assistance programs, or under the supplemental nutrition assistance program established under the
Food and Nutrition Act of 2008 (7 U.S.C. 2011 et
seq.).
(g) Rule of construction
Nothing in this subchapter shall be construed
as prohibiting benefits paid under the CLASS
Independence Benefit Plan from being used to
compensate a family caregiver for providing
community living assistance services and supports to an eligible beneficiary.
(h) Protection against conflict of interests
The Secretary shall establish procedures to
ensure that the Eligibility Assessment System,
the Protection and Advocacy System for a
4 So

in original. Probably should be ‘‘title’’.

Page 1385

TITLE 42—THE PUBLIC HEALTH AND WELFARE

State, advocacy counselors for eligible beneficiaries, and any other entities that provide
services to active enrollees and eligible beneficiaries under the CLASS program comply with
the following:
(1) If the entity provides counseling or planning services, such services are provided in a
manner that fosters the best interests of the
active enrollee or beneficiary.
(2) The entity has established operating procedures that are designed to avoid or minimize
conflicts of interest between the entity and an
active enrollee or beneficiary.
(3) The entity provides information about all
services and options available to the active enrollee or beneficiary, to the best of its knowledge, including services available through
other entities or providers.
(4) The entity assists the active enrollee or
beneficiary to access desired services, regardless of the provider.
(5) The entity reports the number of active
enrollees and beneficiaries provided with assistance by age, disability, and whether such
enrollees and beneficiaries received services
from the entity or another entity.
(6) If the entity provides counseling or planning services, the entity ensures that an active enrollee or beneficiary is informed of any
financial interest that the entity has in a service provider.
(7) The entity provides an active enrollee or
beneficiary with a list of available service providers that can meet the needs of the active
enrollee or beneficiary.
(July 1, 1944, ch. 373, title XXXII, § 3205, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 836.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs.
(a)(2)(A)(i) and (f), is act Aug. 14, 1935, ch. 531, 49 Stat.
620. Titles II, XVI, XVIII, XIX, and XXI of the Act are
classified generally to subchapters II (§ 401 et seq.), XVI
(§ 1381 et seq.), XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.),
and XXI (§ 1397aa et seq.), respectively, of chapter 7 of
this title. For complete classification of this Act to the
Code, see section 1305 of this title and Tables.
Section 300ll–2(b)(2) of this title, referred to in subsec.
(b)(4), was in the original section ‘‘3203(b)(3)’’, and was
translated as meaning section 3203(b)(2) of act July 1,
1944, to reflect the probable intent of Congress.
The Assistive Technology Act of 1998, referred to in
subsec. (e)(4), is Pub. L. 105–394, Nov. 13, 1998, 112 Stat.
3627, which is classified principally to chapter 31 (§ 3001
et seq.) of Title 29, Labor. For complete classification
of this Act to the Code, see Short Title note set out
under section 3001 of Title 29 and Tables.
The Food and Nutrition Act of 2008, referred to in
subsec. (f), is Pub. L. 88–525, Aug. 31, 1964, 78 Stat. 703,
which is classified generally to chapter 51 (§ 2011 et seq.)
of Title 7, Agriculture. For complete classification of
this Act to the Code, see Short Title note set out under
section 2011 of Title 7 and Tables.

§ 300ll–5. CLASS Independence Fund
(a) Establishment of CLASS Independence Fund
There is established in the Treasury of the
United States a trust fund to be known as the
‘‘CLASS Independence Fund’’. The Secretary of
the Treasury shall serve as Managing Trustee of
such Fund. The Fund shall consist of all
amounts derived from payments into the Fund

§ 300ll–5

under sections 300ll–3(f) and 300ll–4(c)(5)(C)(ii) of
this title, and remaining after investment of
such amounts under subsection (b), including
additional amounts derived as income from such
investments. The amounts held in the Fund are
appropriated and shall remain available without
fiscal year limitation—
(1) to be held for investment on behalf of individuals enrolled in the CLASS program;
(2) to pay the administrative expenses related to the Fund and to investment under subsection (b); and
(3) to pay cash benefits to eligible beneficiaries under the CLASS Independence Benefit Plan.
(b) Investment of Fund balance
The Secretary of the Treasury shall invest and
manage the CLASS Independence Fund in the
same manner, and to the same extent, as the
Federal Supplementary Medical Insurance Trust
Fund may be invested and managed under subsections (c), (d), and (e) of section 1395t 1 of this
title.
(c) Board of Trustees
(1) In general
With respect to the CLASS Independence
Fund, there is hereby created a body to be
known as the Board of Trustees of the CLASS
Independence Fund (hereinafter in this section
referred to as the ‘‘Board of Trustees’’) composed of the Secretary of the Treasury, the
Secretary of Labor, and the Secretary of
Health and Human Services, all ex officio, and
of two members of the public (both of whom
may not be from the same political party),
who shall be nominated by the President for a
term of 4 years and subject to confirmation by
the Senate. A member of the Board of Trustees serving as a member of the public and
nominated and confirmed to fill a vacancy occurring during a term shall be nominated and
confirmed only for the remainder of such
term. An individual nominated and confirmed
as a member of the public may serve in such
position after the expiration of such member’s
term until the earlier of the time at which the
member’s successor takes office or the time at
which a report of the Board is first issued
under paragraph (2) after the expiration of the
member’s term. The Secretary of the Treasury
shall be the Managing Trustee of the Board of
Trustees. The Board of Trustees shall meet
not less frequently than once each calendar
year. A person serving on the Board of Trustees shall not be considered to be a fiduciary
and shall not be personally liable for actions
taken in such capacity with respect to the
Trust Fund.
(2) Duties
(A) In general
It shall be the duty of the Board of Trustees to do the following:
(i) Hold the CLASS Independence Fund.
(ii) Report to the Congress not later than
the first day of April of each year on the
operation and status of the CLASS Inde1 See

References in Text note below.

§ 300ll–6

TITLE 42—THE PUBLIC HEALTH AND WELFARE

pendence Fund during the preceding fiscal
year and on its expected operation and
status during the current fiscal year and
the next 2 fiscal years.
(iii) Report immediately to the Congress
whenever the Board is of the opinion that
the amount of the CLASS Independence
Fund is not actuarially sound in regards to
the
projection
under
section
300ll–2(b)(1)(B)(i) of this title.
(iv) Review the general policies followed
in managing the CLASS Independence
Fund, and recommend changes in such
policies, including necessary changes in
the provisions of law which govern the way
in which the CLASS Independence Fund is
to be managed.
(B) Report
The report provided for in subparagraph
(A)(ii) shall—
(i) include—
(I) a statement of the assets of, and the
disbursements made from, the CLASS
Independence Fund during the preceding
fiscal year;
(II) an estimate of the expected income
to, and disbursements to be made from,
the CLASS Independence Fund during
the current fiscal year and each of the
next 2 fiscal years;
(III) a statement of the actuarial
status of the CLASS Independence Fund
for the current fiscal year, each of the
next 2 fiscal years, and as projected over
the 75-year period beginning with the
current fiscal year; and
(IV) an actuarial opinion by the Chief
Actuary of the Centers for Medicare &
Medicaid Services certifying that the
techniques and methodologies used are
generally accepted within the actuarial
profession and that the assumptions and
cost estimates used are reasonable; and
(ii) be printed as a House document of
the session of the Congress to which the
report is made.
(C) Recommendations
If the Board of Trustees determines that
enrollment trends and expected future benefit claims on the CLASS Independence Fund
are not actuarially sound in regards to the
projection under section 300ll–2(b)(1)(B)(i) of
this title and are unlikely to be resolved
with reasonable premium increases or
through other means, the Board of Trustees
shall include in the report provided for in
subparagraph (A)(ii) recommendations for
such legislative action as the Board of
Trustees determine 2 to be appropriate, including whether to adjust monthly premiums or impose a temporary moratorium
on new enrollments.
(July 1, 1944, ch. 373, title XXXII, § 3206, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 842.)
REFERENCES IN TEXT
Section 1395t of this title, referred to in subsec. (b),
was in the original ‘‘section 1841(d) of the Social Secu2 So

in original. Probably should be ‘‘determines’’.

Page 1386

rity Act’’, and was translated as meaning section 1841
of act Aug. 14, 1935, ch. 531, to reflect the probable intent of Congress.

§ 300ll–6. CLASS Independence Advisory Council
(a) Establishment
There is hereby created an Advisory Committee to be known as the ‘‘CLASS Independence
Advisory Council’’.
(b) Membership
(1) In general
The CLASS Independence Advisory Council
shall be composed of not more than 15 individuals, not otherwise in the employ of the
United States—
(A) who shall be appointed by the President without regard to the civil service laws
and regulations; and
(B) a majority of whom shall be representatives of individuals who participate or are
likely to participate in the CLASS program,
and shall include representatives of older
and younger workers, individuals with disabilities, family caregivers of individuals
who require services and supports to maintain their independence at home or in another residential setting of their choice in
the community,1 individuals with expertise
in long-term care or disability insurance, actuarial science, economics, and other relevant disciplines, as determined by the Secretary.
(2) Terms
(A) In general
The members of the CLASS Independence
Advisory Council shall serve overlapping
terms of 3 years (unless appointed to fill a
vacancy occurring prior to the expiration of
a term, in which case the individual shall
serve for the remainder of the term).
(B) Limitation
A member shall not be eligible to serve for
more than 2 consecutive terms.
(3) Chair
The President shall, from time to time, appoint one of the members of the CLASS Independence Advisory Council to serve as the
Chair.
(c) Duties
The CLASS Independence Advisory Council
shall advise the Secretary on matters of general
policy in the administration of the CLASS program established under this subchapter and in
the formulation of regulations under this subchapter including with respect to—
(1) the development of the CLASS Independence Benefit Plan under section 300ll–2 of this
title;
(2) the determination of monthly premiums
under such plan; and
(3) the financial solvency of the program.
(d) Application of FACA
The Federal Advisory Committee Act (5 U.S.C.
App.), other than section 14 of that Act, shall
1 So

in original. The word ‘‘and’’ probably should appear.

Page 1387

TITLE 42—THE PUBLIC HEALTH AND WELFARE

apply to the CLASS Independence Advisory
Council.
(e) Authorization of appropriations
(1) In general
There are authorized to be appropriated to
the CLASS Independence Advisory Council to
carry out its duties under this section, such
sums as may be necessary for fiscal year 2011
and for each fiscal year thereafter.
(2) Availability
Any sums appropriated under the authorization contained in this section shall remain
available, without fiscal year limitation, until
expended.
(July 1, 1944, ch. 373, title XXXII, § 3207, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 844.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (d), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.

§ 300ll–7. Solvency and fiscal independence; regulations; annual report
(a) Solvency
The Secretary shall regularly consult with the
Board of Trustees of the CLASS Independence
Fund and the CLASS Independence Advisory
Council, for purposes of ensuring that enrollees 1
premiums are adequate to ensure the financial
solvency of the CLASS program, both with respect to fiscal years occurring in the near-term
and fiscal years occurring over 20- and 75-year
periods, taking into account the projections required for such periods under subsections
(a)(1)(A)(i) and (b)(1)(B)(i) of section 300ll–2 2 of
this title.
(b) No taxpayer funds used to pay benefits
No taxpayer funds shall be used for payment of
benefits under a CLASS Independent Benefit
Plan. For purposes of this subsection, the term
‘‘taxpayer funds’’ means any Federal funds from
a source other than premiums deposited by
CLASS program participants in the CLASS
Independence Fund and any associated interest
earnings.
(c) Regulations
The Secretary shall promulgate such regulations as are necessary to carry out the CLASS
program in accordance with this subchapter.
Such regulations shall include provisions to prevent fraud and abuse under the program.
(d) Annual report
Beginning January 1, 2014, the Secretary shall
submit an annual report to Congress on the
CLASS program. Each report shall include the
following:
(1) The total number of enrollees in the program.
(2) The total number of eligible beneficiaries
during the fiscal year.
(3) The total amount of cash benefits provided during the fiscal year.
1 So

in original. Probably should be ‘‘enrollees’ ’’.
References in Text note below.

2 See

§ 300mm

(4) A description of instances of fraud or
abuse identified during the fiscal year.
(5) Recommendations for such administrative or legislative action as the Secretary determines is necessary to improve the program,
ensure the solvency of the program, or to prevent the occurrence of fraud or abuse.
(July 1, 1944, ch. 373, title XXXII, § 3208, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 845.)
REFERENCES IN TEXT
Section 300ll–2 of this title, referred to in subsec. (a),
was in the original section ‘‘3202’’, and was translated
as meaning section 3203 of act July 1, 1944, to reflect
the probable intent of Congress. Section 3202, which is
classified to section 300ll–1 of this title, does not contain a subsec. (a) or (b).

§ 300ll–8. Inspector General’s report
The Inspector General of the Department of
Health and Human Services shall submit an annual report to the Secretary and Congress relating to the overall progress of the CLASS program and of the existence of waste, fraud, and
abuse in the CLASS program. Each such report
shall include findings in the following areas:
(1) The eligibility determination process.
(2) The provision of cash benefits.
(3) Quality assurance and protection against
waste, fraud, and abuse.
(4) Recouping of unpaid and accrued benefits.
(July 1, 1944, ch. 373, title XXXII, § 3209, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 845.)
§ 300ll–9. Tax treatment of program
The CLASS program shall be treated for purposes of title 26 in the same manner as a qualified long-term care insurance contract for qualified long-term care services.
(July 1, 1944, ch. 373, title XXXII, § 3210, as added
Pub. L. 111–148, title VIII, § 8002(a)(1), Mar. 23,
2010, 124 Stat. 846.)
SUBCHAPTER XXXI—WORLD TRADE
CENTER HEALTH PROGRAM
PART A—ESTABLISHMENT OF PROGRAM;
ADVISORY COMMITTEE
§ 300mm. Establishment of World Trade Center
Health Program
(a) In general
There is hereby established within the Department of Health and Human Services a program
to be known as the World Trade Center Health
Program, which shall be administered by the
WTC Program Administrator, to provide beginning on July 1, 2011—
(1) medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup workers (including those
who are Federal employees) who responded to
the September 11, 2001, terrorist attacks; and
(2) initial health evaluation, monitoring,
and treatment benefits to residents and other
building occupants and area workers in New

§ 300mm

TITLE 42—THE PUBLIC HEALTH AND WELFARE

York City who were directly impacted and adversely affected by such attacks.
(b) Components of program
The WTC Program includes the following components:
(1) Medical monitoring for responders
Medical monitoring under section 300mm–21
of this title, including clinical examinations
and long-term health monitoring and analysis
for enrolled WTC responders who were likely
to have been exposed to airborne toxins that
were released, or to other hazards, as a result
of the September 11, 2001, terrorist attacks.
(2) Initial health evaluation for survivors
An initial health evaluation under section
300mm–31 of this title, including an evaluation
to determine eligibility for followup monitoring and treatment.
(3) Followup monitoring and treatment for
WTC-related health conditions for responders and survivors
Provision
under
sections
300mm–22,
300mm–32, and 300mm–33 of this title of followup monitoring and treatment and payment,
subject to the provisions of subsection (d), for
all medically necessary health and mental
health care expenses of an individual with respect to a WTC-related health condition (including necessary prescription drugs).
(4) Outreach
Establishment under section 300mm–2 of this
title of an education and outreach program to
potentially eligible individuals concerning the
benefits under this subchapter.
(5) Clinical data collection and analysis
Collection and analysis under section
300mm–3 of this title of health and mental
health data relating to individuals receiving
monitoring or treatment benefits in a uniform
manner in collaboration with the collection of
epidemiological data under section 300mm–52
of this title.
(6) Research on health conditions
Establishment under part C of a research
program on health conditions resulting from
the September 11, 2001, terrorist attacks.
(c) No cost sharing
Monitoring and treatment benefits and initial
health evaluation benefits are provided under
part B without any deductibles, copayments, or
other cost sharing to an enrolled WTC responder
or certified-eligible WTC survivor. Initial health
evaluation benefits are provided under part B
without any deductibles, copayments, or other
cost sharing to a screening-eligible WTC survivor.
(d) Preventing fraud and unreasonable administrative costs
(1) Fraud
The Inspector General of the Department of
Health and Human Services shall develop and
implement a program to review the WTC Program’s health care expenditures to detect
fraudulent or duplicate billing and payment
for inappropriate services. This subchapter is

Page 1388

a Federal health care program (as defined in
section 1320a–7b(f) of this title) and is a health
plan (as defined in section 1320a–7c(c) of this
title) for purposes of applying sections 1320a–7
through 1320a–7e of this title.
(2) Unreasonable administrative costs
The Inspector General of the Department of
Health and Human Services shall develop and
implement a program to review the WTC Program for unreasonable administrative costs,
including with respect to infrastructure, administration, and claims processing.
(e) Quality assurance
The WTC Program Administrator working
with the Clinical Centers of Excellence shall develop and implement a quality assurance program for the monitoring and treatment delivered by such Centers of Excellence and any
other participating health care providers. Such
program shall include—
(1) adherence to monitoring and treatment
protocols;
(2) appropriate diagnostic and treatment referrals for participants;
(3) prompt communication of test results to
participants; and
(4) such other elements as the Administrator
specifies in consultation with the Clinical Centers of Excellence.
(f) Annual program report
(1) In general
Not later than 6 months after the end of
each fiscal year in which the WTC Program is
in operation, the WTC Program Administrator
shall submit an annual report to the Congress
on the operations of this subchapter for such
fiscal year and for the entire period of operation of the program.
(2) Contents included in report
Each annual report under paragraph (1) shall
include at least the following:
(A) Eligible individuals
Information for each clinical program described in paragraph (3)—
(i) on the number of individuals who applied for certification under part B and the
number of such individuals who were so
certified;
(ii) of the individuals who were certified,
on the number who received monitoring
under the program and the number of such
individuals who received medical treatment under the program;
(iii) with respect to individuals so certified who received such treatment, on the
WTC-related health conditions for which
they were treated; and
(iv) on the projected number of individuals who will be certified under part B in
the succeeding fiscal year and the succeeding 10-year period.
(B) Monitoring, initial health evaluation, and
treatment costs
For each clinical program so described—
(i) information on the costs of monitoring and initial health evaluation and the
costs of treatment and on the estimated

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

costs of such monitoring, evaluation, and
treatment in the succeeding fiscal year;
and
(ii) an estimate of the cost of medical
treatment for WTC-related health conditions that have been paid for or reimbursed by workers’ compensation, by public or private health plans, or by New York
City under section 300mm–41 of this title.
(C) Administrative costs
Information on the cost of administering
the program, including costs of program support, data collection and analysis, and research conducted under the program.
(D) Administrative experience
Information on the administrative performance of the program, including—
(i) the performance of the program in
providing timely evaluation of and treatment to eligible individuals; and
(ii) a list of the Clinical Centers of Excellence and other providers that are participating in the program.
(E) Scientific reports
A summary of the findings of any new scientific reports or studies on the health effects associated with exposure described in
section 300mm–5(1) of this title, including
the findings of research conducted under section 300mm–51(a) of this title.
(F) Advisory Committee recommendations
A list of recommendations by the WTC
Scientific/Technical Advisory Committee on
additional WTC Program eligibility criteria
and on additional WTC-related health conditions and the action of the WTC Program
Administrator concerning each such recommendation.
(3) Separate clinical programs described
In paragraph (2), each of the following shall
be treated as a separate clinical program of
the WTC Program:
(A) Firefighters and related personnel
The benefits provided for enrolled WTC responders
described
in
section
300mm–21(a)(2)(A) of this title.
(B) Other WTC responders
The benefits provided for enrolled WTC responders not described in subparagraph (A).
(C) WTC survivors
The benefits provided for screening-eligible WTC survivors and certified-eligible
WTC survivors in section 300mm–31(a) of this
title.
(g) Notification to Congress upon reaching 80
percent of eligibility numerical limits
The Secretary shall promptly notify the Congress of each of the following:
(1) When the number of enrollments of WTC
responders subject to the limit established
under section 300mm–21(a)(4) of this title has
reached 80 percent of such limit.
(2) When the number of certifications for
certified-eligible WTC survivors subject to the
limit established under section 300mm–31(a)(3)

§ 300mm–1

of this title has reached 80 percent of such
limit.
(h) Consultation
The WTC Program Administrator shall engage
in ongoing outreach and consultation with relevant stakeholders, including the WTC Health
Program Steering Committees and the Advisory
Committee under section 300mm–1 of this title,
regarding the implementation and improvement
of programs under this subchapter.
(July 1, 1944, ch. 373, title XXXIII, § 3301, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3624.)
§ 300mm–1. WTC Health Program Scientific/Technical Advisory Committee; WTC Health Program Steering Committees
(a) Advisory Committee
(1) Establishment
The WTC Program Administrator shall establish an advisory committee to be known as
the WTC Health Program Scientific/Technical
Advisory Committee (in this subsection referred to as the ‘‘Advisory Committee’’) to review scientific and medical evidence and to
make recommendations to the Administrator
on additional WTC Program eligibility criteria and on additional WTC-related health
conditions.
(2) Composition
The WTC Program Administrator shall appoint the members of the Advisory Committee
and shall include at least—
(A) 4 occupational physicians, at least 2 of
whom have experience treating WTC rescue
and recovery workers;
(B) 1 physician with expertise in pulmonary medicine;
(C) 2 environmental medicine or environmental health specialists;
(D) 2 representatives of WTC responders;
(E) 2 representatives of certified-eligible
WTC survivors;
(F) an industrial hygienist;
(G) a toxicologist;
(H) an epidemiologist; and
(I) a mental health professional.
(3) Meetings
The Advisory Committee shall meet at such
frequency as may be required to carry out its
duties.
(4) Reports
The WTC Program Administrator shall provide for publication of recommendations of the
Advisory Committee on the public Web site established for the WTC Program.
(5) Duration
Notwithstanding any other provision of law,
the Advisory Committee shall continue in operation during the period in which the WTC
Program is in operation.
(6) Application of FACA
Except as otherwise specifically provided,
the Advisory Committee shall be subject to
the Federal Advisory Committee Act.

§ 300mm–2

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) WTC Health Program Steering Committees
(1) Consultation
The WTC Program Administrator shall consult with 2 steering committees (each in this
section referred to as a ‘‘Steering Committee’’) that are established as follows:
(A) WTC Responders Steering Committee
One Steering Committee, to be known as
the WTC Responders Steering Committee,
for the purpose of receiving input from affected stakeholders and facilitating the coordination of monitoring and treatment programs for the enrolled WTC responders
under subpart 1 of part B.
(B) WTC Survivors Steering Committee
One Steering Committee, to be known as
the WTC Survivors Steering Committee, for
the purpose of receiving input from affected
stakeholders and facilitating the coordination of initial health evaluations, monitoring, and treatment programs for screeningeligible and certified-eligible WTC survivors
under subpart 2 of part B.
(2) Membership
(A) WTC Responders Steering Committee
(i) Representation
The WTC Responders Steering Committee shall include—
(I) representatives of the Centers of
Excellence providing services to WTC responders;
(II) representatives of labor organizations representing firefighters, police,
other New York City employees, and recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks; and
(III) 3 representatives of New York
City, 1 of whom will be selected by the
police commissioner of New York City, 1
by the health commissioner of New York
City, and 1 by the mayor of New York
City.
(ii) Initial membership
The WTC Responders Steering Committee shall initially be composed of members
of the WTC Monitoring and Treatment
Program Steering Committee (as in existence on the day before January 2, 2011).
(B) WTC Survivors Steering Committee
(i) Representation
The WTC Survivors Steering Committee
shall include representatives of—
(I) the Centers of Excellence providing
services to screening-eligible and certified-eligible WTC survivors;
(II) the population of residents, students, and area and other workers affected by the September 11, 2001, terrorist attacks;
(III) screening-eligible and certified-eligible survivors receiving initial health
evaluations, monitoring, or treatment
under subpart 2 of part B and organizations advocating on their behalf; and
(IV) New York City.

Page 1390

(ii) Initial membership
The WTC Survivors Steering Committee
shall initially be composed of members of
the WTC Environmental Health Center
Survivor Advisory Committee (as in existence on the day before January 2, 2011).
(C) Additional appointments
Each Steering Committee may recommend, if approved by a majority of voting
members of the Committee, additional members to the Committee.
(D) Vacancies
A vacancy in a Steering Committee shall
be filled by an individual recommended by
the Steering Committee.
(July 1, 1944, ch. 373, title XXXIII, § 3302, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3627.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (a)(6), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.

§ 300mm–2. Education and outreach
The WTC Program Administrator shall institute a program that provides education and outreach on the existence and availability of services under the WTC Program. The outreach and
education program—
(1) shall include—
(A) the establishment of a public Web site
with information about the WTC Program;
(B) meetings with potentially eligible populations;
(C) development and dissemination of outreach materials informing people about the
program; and
(D) the establishment of phone information services; and
(2) shall be conducted in a manner intended—
(A) to reach all affected populations; and
(B) to include materials for culturally and
linguistically diverse populations.
(July 1, 1944, ch. 373, title XXXIII, § 3303, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3629.)
§ 300mm–3. Uniform data collection and analysis
(a) In general
The WTC Program Administrator shall provide for the uniform collection of data, including claims data (and analysis of data and regular reports to the Administrator) on the prevalence of WTC-related health conditions and the
identification of new WTC-related health conditions. Such data shall be collected for all individuals provided monitoring or treatment benefits under part B and regardless of their place of
residence or Clinical Center of Excellence
through which the benefits are provided. The
WTC Program Administrator shall provide,
through the Data Centers or otherwise, for the
integration of such data into the monitoring and
treatment program activities under this subchapter.

Page 1391

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(b) Coordinating through Centers of Excellence
Each Clinical Center of Excellence shall collect data described in subsection (a) and report
such data to the corresponding Data Center for
analysis by such Data Center.
(c) Collaboration with WTC Health Registry
The WTC Program Administrator shall provide for collaboration between the Data Centers
and the World Trade Center Health Registry described in section 300mm–52 of this title.
(d) Privacy
The data collection and analysis under this
section shall be conducted and maintained in a
manner that protects the confidentiality of individually identifiable health information consistent with applicable statutes and regulations, including, as applicable, HIPAA privacy and security law (as defined in section 300jj–19(a)(2) of
this title) and section 552a of title 5.
(July 1, 1944, ch. 373, title XXXIII, § 3304, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3629.)
§ 300mm–4. Clinical Centers of Excellence and
Data Centers
(a) In general
(1) Contracts with Clinical Centers of Excellence
The WTC Program Administrator shall, subject to subsection (b)(1)(B), enter into contracts with Clinical Centers of Excellence (as
defined in subsection (b)(1)(A))—
(A) for the provision of monitoring and
treatment benefits and initial health evaluation benefits under part B;
(B) for the provision of outreach activities
to individuals eligible for such monitoring
and treatment benefits, for initial health
evaluation benefits, and for followup to individuals who are enrolled in the monitoring
program;
(C) for the provision of counseling for benefits under part B, with respect to WTC-related health conditions, for individuals eligible for such benefits;
(D) for the provision of counseling for benefits for WTC-related health conditions that
may be available under workers’ compensation or other benefit programs for work-related injuries or illnesses, health insurance,
disability insurance, or other insurance
plans or through public or private social
service agencies and assisting eligible individuals in applying for such benefits;
(E) for the provision of translational and
interpretive services for program participants who are not English language proficient; and
(F) for the collection and reporting of
data, including claims data, in accordance
with section 300mm–3 of this title.
(2) Contracts with Data Centers
(A) In general
The WTC Program Administrator shall
enter into contracts with one or more Data
Centers (as defined in subsection (b)(2))—
(i) for receiving, analyzing, and reporting to the WTC Program Administrator on

§ 300mm–4

data, in accordance with section 300mm–3
of this title, that have been collected and
reported to such Data Centers by the corresponding Clinical Centers of Excellence
under subsection (b)(1)(B)(iii);
(ii) for the development of monitoring,
initial health evaluation, and treatment
protocols, with respect to WTC-related
health conditions;
(iii) for coordinating the outreach activities conducted under paragraph (1)(B) by
each corresponding Clinical Center of Excellence;
(iv) for establishing criteria for the credentialing of medical providers participating in the nationwide network under section 300mm–23 of this title;
(v) for coordinating and administering
the activities of the WTC Health Program
Steering Committees established under
section 300mm–1(b) of this title; and
(vi) for meeting periodically with the
corresponding Clinical Centers of Excellence to obtain input on the analysis and
reporting of data collected under clause (i)
and on the development of monitoring, initial health evaluation, and treatment protocols under clause (ii).
(B) Medical provider selection
The medical providers under subparagraph
(A)(iv) shall be selected by the WTC Program Administrator on the basis of their experience treating or diagnosing the health
conditions included in the list of WTC-related health conditions.
(C) Clinical discussions
In carrying out subparagraph (A)(ii), a
Data Center shall engage in clinical discussions across the WTC Program to guide
treatment approaches for individuals with a
WTC-related health condition.
(D) Transparency of data
A contract entered into under this subsection with a Data Center shall require the
Data Center to make any data collected and
reported to such Center under subsection
(b)(1)(B)(iii) available to health researchers
and others as provided in the CDC/ATSDR
Policy on Releasing and Sharing Data.
(3) Authority for contracts to be class specific
A contract entered into under this subsection with a Clinical Center of Excellence or
a Data Center may be with respect to one or
more class of enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors.
(4) Use of cooperative agreements
Any contract under this subchapter between
the WTC Program Administrator and a Data
Center or a Clinical Center of Excellence may
be in the form of a cooperative agreement.
(5) Review on feasibility of consolidating Data
Centers
Not later than July 1, 2011, the Comptroller
General of the United States shall submit to
the Committee on Energy and Commerce of
the House of Representatives and the Commit-

§ 300mm–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

tee on Health, Education, Labor, and Pensions
of the Senate a report on the feasibility of
consolidating Data Centers into a single Data
Center.
(b) Centers of Excellence
(1) Clinical Centers of Excellence
(A) Definition
For purposes of this subchapter, the term
‘‘Clinical Center of Excellence’’ means a
Center that demonstrates to the satisfaction
of the Administrator that the Center—
(i) uses an integrated, centralized health
care provider approach to create a comprehensive suite of health services under this
subchapter that are accessible to enrolled
WTC responders, screening-eligible WTC
survivors, or certified-eligible WTC survivors;
(ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes health care providers
who have been trained pursuant to section
300mm–23(c) of this title;
(iii) employs health care provider staff
with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services
counseling; and
(iv) meets such other requirements as
specified by the Administrator.
(B) Contract requirements
The WTC Program Administrator shall not
enter into a contract with a Clinical Center
of Excellence under subsection (a)(1) unless
the Center agrees to do each of the following:
(i) Establish a formal mechanism for
consulting with and receiving input from
representatives of eligible populations receiving monitoring and treatment benefits
under part B from such Center.
(ii) Coordinate monitoring and treatment benefits under part B with routine
medical care provided for the treatment of
conditions other than WTC-related health
conditions.
(iii) Collect and report to the corresponding Data Center data, including
claims data, in accordance with section
300mm–3(b) of this title.
(iv) Have in place safeguards against
fraud that are satisfactory to the Administrator, in consultation with the Inspector
General of the Department of Health and
Human Services.
(v) Treat or refer for treatment all individuals who are enrolled WTC responders
or certified-eligible WTC survivors with respect to such Center who present themselves for treatment of a WTC-related
health condition.
(vi) Have in place safeguards, consistent
with section 300mm–3(c) of this title, to
ensure the confidentiality of an individual’s individually identifiable health information, including requiring that such information not be disclosed to the individual’s employer without the authorization
of the individual.

Page 1392

(vii) Use amounts paid under subsection
(c)(1) only for costs incurred in carrying
out the activities described in subsection
(a), other than those described in subsection (a)(1)(A).
(viii) Utilize health care providers with
occupational and environmental medicine
expertise to conduct physical and mental
health assessments, in accordance with
protocols developed under subsection
(a)(2)(A)(ii).
(ix) Communicate with WTC responders
and screening-eligible and certified-eligible WTC survivors in appropriate languages and conduct outreach activities
with relevant stakeholder worker or community associations.
(x) Meet all the other applicable requirements of this subchapter, including regulations implementing such requirements.
(C) Transition rule to ensure continuity of
care
The WTC Program Administrator shall to
the maximum extent feasible ensure continuity of care in any period of transition
from monitoring and treatment of an enrolled WTC responder or certified-eligible
WTC survivor by a provider to a Clinical
Center of Excellence or a health care provider participating in the nationwide network under section 300mm–23 of this title.
(2) Data Centers
For purposes of this subchapter, the term
‘‘Data Center’’ means a Center that the WTC
Program Administrator determines has the
capacity to carry out the responsibilities for a
Data Center under subsection (a)(2).
(3) Corresponding centers
For purposes of this subchapter, a Clinical
Center of Excellence and a Data Center shall
be treated as ‘‘corresponding’’ to the extent
that such Clinical Center and Data Center
serve the same population group.
(c) Payment for infrastructure costs
(1) In general
The WTC Program Administrator shall reimburse a Clinical Center of Excellence for the
fixed infrastructure costs of such Center in
carrying out the activities described in part B
at a rate negotiated by the Administrator and
such Centers. Such negotiated rate shall be
fair and appropriate and take into account the
number of enrolled WTC responders receiving
services from such Center under this subchapter.
(2) Fixed infrastructure costs
For purposes of paragraph (1), the term
‘‘fixed infrastructure costs’’ means, with respect to a Clinical Center of Excellence, the
costs incurred by such Center that are not
otherwise reimbursable by the WTC Program
Administrator under section 300mm–22(c) of
this title for patient evaluation, monitoring,
or treatment but which are needed to operate
the WTC program such as the costs involved in
outreach to participants or recruiting participants, data collection and analysis, social

Page 1393

TITLE 42—THE PUBLIC HEALTH AND WELFARE

services for counseling patients on other available assistance outside the WTC program, and
the development of treatment protocols. Such
term does not include costs for new construction or other capital costs.
(d) GAO analysis
Not later than July 1, 2011, the Comptroller
General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate an analysis
on whether Clinical Centers of Excellence with
which the WTC Program Administrator enters
into a contract under this section have financial
systems that will allow for the timely submission of claims data for purposes of section
300mm–3 of this title and subsections (a)(1)(F)
and (b)(1)(B)(iii).
(July 1, 1944, ch. 373, title XXXIII, § 3305, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3630.)
§ 300mm–5. Definitions
In this subchapter:
(1) The term ‘‘aggravating’’ means, with respect to a health condition, a health condition
that existed on September 11, 2001, and that,
as a result of exposure to airborne toxins, any
other hazard, or any other adverse condition
resulting from the September 11, 2001, terrorist attacks, requires medical treatment that is
(or will be) in addition to, more frequent than,
or of longer duration than the medical treatment that would have been required for such
condition in the absence of such exposure.
(2) The term ‘‘certified-eligible WTC survivor’’ has the meaning given such term in
section 300mm–31(a)(2) of this title.
(3) The terms ‘‘Clinical Center of Excellence’’ and ‘‘Data Center’’ have the meanings
given such terms in section 300mm–4 of this
title.
(4) The term ‘‘enrolled WTC responder’’
means a WTC responder enrolled under section
300mm–21(a)(3) of this title.
(5) The term ‘‘initial health evaluation’’ includes, with respect to an individual, a medical and exposure history, a physical examination, and additional medical testing as needed
to evaluate whether the individual has a WTCrelated health condition and is eligible for
treatment under the WTC Program.
(6) The term ‘‘list of WTC-related health
conditions’’ means—
(A) for WTC responders, the health conditions listed in section 300mm–22(a)(3) of this
title; and
(B) for screening-eligible and certified-eligible WTC survivors, the health conditions
listed in section 300mm–32(b) of this title.
(7) The term ‘‘New York City disaster area’’
means the area within New York City that is—
(A) the area of Manhattan that is south of
Houston Street; and
(B) any block in Brooklyn that is wholly
or partially contained within a 1.5-mile radius of the former World Trade Center site.
(8) The term ‘‘New York metropolitan area’’
means an area, specified by the WTC Program

§ 300mm–5

Administrator, within which WTC responders
and eligible WTC screening-eligible survivors
who reside in such area are reasonably able to
access monitoring and treatment benefits and
initial health evaluation benefits under this
subchapter through a Clinical Center of Excellence described in subparagraphs (A), (B), or
(C) of section 300mm–4(b)(1) of this title.
(9) The term ‘‘screening-eligible WTC survivor’’ has the meaning given such term in
section 300mm–31(a)(1) of this title.
(10) Any reference to ‘‘September 11, 2001’’
shall be deemed a reference to the period on
such date subsequent to the terrorist attacks
at the World Trade Center, Shanksville, Pennsylvania, or the Pentagon, as applicable, on
such date.
(11) The term ‘‘September 11, 2001, terrorist
attacks’’ means the terrorist attacks that occurred on September 11, 2001, in New York
City, in Shanksville, Pennsylvania, and at the
Pentagon, and includes the aftermath of such
attacks.
(12) The term ‘‘WTC Health Program Steering Committee’’ means such a Steering Committee established under section 300mm–1(b) of
this title.
(13) The term ‘‘WTC Program’’ means the
Word Trade Center Health Program established under section 300mm(a) of this title.
(14)(A) The term ‘‘WTC Program Administrator’’ means—
(i) subject to subparagraph (B), with respect to paragraphs (3) and (4) of section
300mm–21(a) of this title (relating to enrollment
of
WTC
responders),
section
300mm–22(c) of this title and the corresponding provisions of section 300mm–32 of this
title (relating to payment for initial health
evaluation, monitoring, and treatment,1
paragraphs (1)(C), (2)(B), and (3) of section
300mm–31(a) of this title (relating to determination or certification of screening-eligible or certified-eligible WTC responders),
and subpart 3 of part B (relating to payor
provisions), an official in the Department of
Health and Human Services, to be designated by the Secretary; and
(ii) with respect to any other provision of
this subchapter, the Director of the National
Institute for Occupational Safety and
Health, or a designee of such Director.
(B) In no case may the Secretary designate
under subparagraph (A)(i) the Director of the
National Institute for Occupational Safety
and Health or a designee of such Director with
respect to section 300mm–32 of this title (relating to payment for initial health evaluation,
monitoring, and treatment).
(15) The term ‘‘WTC-related health condition’’ is defined in section 300mm–22(a) of this
title.
(16) The term ‘‘WTC responder’’ is defined in
section 300mm–21(a) of this title.
(17) The term ‘‘WTC Scientific/Technical Advisory Committee’’ means such Committee established under section 300mm–1(a) of this
title.
1 So in original. A closing parenthesis probably should precede
the comma.

§ 300mm–21

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(July 1, 1944, ch. 373, title XXXIII, § 3306, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3633.)
PART B—PROGRAM OF MONITORING, INITIAL
HEALTH EVALUATIONS, AND TREATMENT
SUBPART 1—WTC RESPONDERS

§ 300mm–21. Identification of WTC responders
and provision of WTC-related monitoring
services
(a) WTC responder defined
(1) In general
For purposes of this subchapter, the term
‘‘WTC responder’’ means any of the following
individuals, subject to paragraph (4):
(A) Currently identified responder
An individual who has been identified as
eligible for monitoring under the arrangements as in effect on January 2, 2011, between the National Institute for Occupational Safety and Health and—
(i) the consortium coordinated by Mt.
Sinai Hospital in New York City that coordinates the monitoring and treatment
for enrolled WTC responders other than
with respect to those covered under the arrangement with the Fire Department of
New York City; or
(ii) the Fire Department of New York
City.
(B) Responder who meets current eligibility
criteria
An individual who meets the current eligibility criteria described in paragraph (2).
(C) Responder who meets modified eligibility
criteria
An individual who—
(i) performed rescue, recovery, demolition, debris cleanup, or other related services in the New York City disaster area in
response to the September 11, 2001, terrorist attacks, regardless of whether such
services were performed by a State or Federal employee or member of the National
Guard or otherwise; and
(ii) meets such eligibility criteria relating to exposure to airborne toxins, other
hazards, or adverse conditions resulting
from the September 11, 2001, terrorist attacks as the WTC Program Administrator,
after consultation with the WTC Scientific/Technical Advisory Committee, determines appropriate.
The WTC Program Administrator shall not
modify such eligibility criteria on or after
the date that the number of enrollments of
WTC responders has reached 80 percent of
the limit described in paragraph (4) or on or
after the date that the number of certifications for certified-eligible WTC survivors
under section 300mm–31(a)(2)(B) of this title
has reached 80 percent of the limit described
in section 300mm–31(a)(3) of this title.
(2) Current eligibility criteria
The eligibility criteria described in this
paragraph for an individual is that the individ-

Page 1394

ual is described in any of the following categories:
(A) Firefighters and related personnel
The individual—
(i) was a member of the Fire Department
of New York City (whether fire or emergency personnel, active or retired) who
participated at least one day in the rescue
and recovery effort at any of the former
World Trade Center sites (including
Ground Zero, Staten Island Landfill, and
the New York City Chief Medical Examiner’s Office) for any time during the period
beginning on September 11, 2001, and ending on July 31, 2002; or
(ii)(I) is a surviving immediate family
member of an individual who was a member of the Fire Department of New York
City (whether fire or emergency personnel,
active or retired) and was killed at the
World Trade site on September 11, 2001;
and
(II) received any treatment for a WTCrelated health condition described in section 300mm–22(a)(1)(A)(ii) of this title (relating to mental health conditions) on or
before September 1, 2008.
(B) Law enforcement officers and WTC rescue, recovery, and cleanup workers
The individual—
(i) worked or volunteered onsite in rescue, recovery, debris cleanup, or related
support services in lower Manhattan
(south of Canal St.), the Staten Island
Landfill, or the barge loading piers, for at
least 4 hours during the period beginning
on September 11, 2001, and ending on September 14, 2001, for at least 24 hours during
the period beginning on September 11, 2001,
and ending on September 30, 2001, or for at
least 80 hours during the period beginning
on September 11, 2001, and ending on July
31, 2002;
(ii)(I) was a member of the Police Department of New York City (whether active or retired) or a member of the Port
Authority Police of the Port Authority of
New York and New Jersey (whether active
or retired) who participated onsite in rescue, recovery, debris cleanup, or related
services in lower Manhattan (south of
Canal St.), including Ground Zero, the
Staten Island Landfill, or the barge loading piers, for at least 4 hours during the
period beginning September 11, 2001, and
ending on September 14, 2001;
(II) participated onsite in rescue, recovery, debris cleanup, or related services at
Ground Zero, the Staten Island Landfill, or
the barge loading piers, for at least one
day during the period beginning on September 11, 2001, and ending on July 31, 2002;
(III) participated onsite in rescue, recovery, debris cleanup, or related services in
lower Manhattan (south of Canal St.) for
at least 24 hours during the period beginning on September 11, 2001, and ending on
September 30, 2001; or
(IV) participated onsite in rescue, recovery, debris cleanup, or related services in

Page 1395

TITLE 42—THE PUBLIC HEALTH AND WELFARE

lower Manhattan (south of Canal St.) for
at least 80 hours during the period beginning on September 11, 2001, and ending on
July 31, 2002;
(iii) was an employee of the Office of the
Chief Medical Examiner of New York City
involved in the examination and handling
of human remains from the World Trade
Center attacks, or other morgue worker
who performed similar post-September 11
functions for such Office staff, during the
period beginning on September 11, 2001,
and ending on July 31, 2002;
(iv) was a worker in the Port Authority
Trans-Hudson Corporation Tunnel for at
least 24 hours during the period beginning
on February 1, 2002, and ending on July 1,
2002; or
(v) was a vehicle-maintenance worker
who was exposed to debris from the former
World Trade Center while retrieving, driving, cleaning, repairing, and maintaining
vehicles contaminated by airborne toxins
from the September 11, 2001, terrorist attacks during a duration and period described in subparagraph (A).
(C) Responders to the September 11 attacks
at the Pentagon and Shanksville, Pennsylvania
The individual—
(i)(I) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery,
demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September
11, 2001, during the period beginning on
September 11, 2001, and ending on the date
on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; or
(II) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery,
demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related aircraft
crash of September 11, 2001, during the period beginning on September 11, 2001, and
ending on the date on which the cleanup of
the site was concluded, as determined by
the WTC Program Administrator; and
(ii) is determined by the WTC Program
Administrator to be at an increased risk of
developing a WTC-related health condition
as a result of exposure to airborne toxins,
other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks, and meets such eligibility criteria related to such exposures, as the
WTC Program Administrator determines
are appropriate, after consultation with
the WTC Scientific/Technical Advisory
Committee.

§ 300mm–21

(3) Enrollment process
(A) In general
The WTC Program Administrator shall establish a process for enrolling WTC responders in the WTC Program. Under such process—
(i) WTC responders described in paragraph (1)(A) shall be deemed to be enrolled
in such Program;
(ii) subject to clause (iii), the Administrator shall enroll in such program individuals who are determined to be WTC responders;
(iii) the Administrator shall deny such
enrollment to an individual if the Administrator determines that the numerical
limitation in paragraph (4) on enrollment
of WTC responders has been met;
(iv) there shall be no fee charged to the
applicant for making an application for
such enrollment;
(v) the Administrator shall make a determination on such an application not
later than 60 days after the date of filing
the application; and
(vi) an individual who is denied enrollment in such Program shall have an opportunity to appeal such determination in a
manner established under such process.
(B) Timing
(i) Currently identified responders
In accordance with subparagraph (A)(i),
the WTC Program Administrator shall enroll an individual described in paragraph
(1)(A) in the WTC Program not later than
July 1, 2011.
(ii) Other responders
In accordance with subparagraph (A)(ii)
and consistent with paragraph (4), the
WTC Program Administrator shall enroll
any other individual who is determined to
be a WTC responder in the WTC Program
at the time of such determination.
(4) Numerical limitation on eligible WTC responders
(A) In general
The total number of individuals not described in paragraph (1)(A) or (2)(A)(ii) who
may be enrolled under paragraph (3)(A)(ii)
shall not exceed 25,000 at any time, of which
no more than 2,500 may be individuals enrolled based on modified eligibility criteria
established under paragraph (1)(C).
(B) Process
In implementing subparagraph (A), the
WTC Program Administrator shall—
(i) limit the number of enrollments made
under paragraph (3)—
(I) in accordance with such subparagraph; and
(II) to such number, as determined by
the Administrator based on the best
available information and subject to
amounts
available
under
section
300mm–61 of this title, that will ensure
sufficient funds will be available to provide treatment and monitoring benefits

§ 300mm–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

under this subchapter, with respect to
all individuals who are enrolled through
the end of fiscal year 2020; and
(ii) provide priority (subject to paragraph (3)(A)(i)) in such enrollments in the
order in which individuals apply for enrollment under paragraph (3).
(5) Disqualification of individuals on terrorist
watch list
No individual who is on the terrorist watch
list maintained by the Department of Homeland Security shall qualify as an eligible WTC
responder. Before enrolling any individual as a
WTC responder in the WTC Program under
paragraph (3), the Administrator, in consultation with the Secretary of Homeland Security,
shall determine whether the individual is on
such list.
(b) Monitoring benefits
(1) In general
In the case of an enrolled WTC responder
(other than one described in subsection
(a)(2)(A)(ii)), the WTC Program shall provide
for monitoring benefits that include monitoring consistent with protocols approved by the
WTC Program Administrator and including
clinical examinations and long-term health
monitoring and analysis. In the case of an enrolled WTC responder who is an active member
of the Fire Department of New York City, the
responder shall receive such benefits as part of
the individual’s periodic company medical
exams.
(2) Provision of monitoring benefits
The monitoring benefits under paragraph (1)
shall be provided through the Clinical Center
of Excellence for the type of individual involved or, in the case of an individual residing
outside the New York metropolitan area,
under an arrangement under section 300mm–23
of this title.
(July 1, 1944, ch. 373, title XXXIII, § 3311, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3635.)
§ 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions
(a) WTC-related health condition defined
(1) In general
For purposes of this subchapter, the term
‘‘WTC-related health condition’’ means a condition that—
(A)(i) is an illness or health condition for
which exposure to airborne toxins, any other
hazard, or any other adverse condition resulting from the September 11, 2001, terrorist
attacks, based on an examination by a medical professional with experience in treating
or diagnosing the health conditions included
in the applicable list of WTC-related health
conditions, is substantially likely to be a
significant factor in aggravating, contributing to, or causing the illness or health condition, as determined under paragraph (2); or
(ii) is a mental health condition for which
such attacks, based on an examination by a
medical professional with experience in

Page 1396

treating or diagnosing the health conditions
included in the applicable list of WTC-related health conditions, is substantially likely
to be a significant factor in aggravating,
contributing to, or causing the condition, as
determined under paragraph (2); and
(B) is included in the applicable list of
WTC-related health conditions or—
(i) with respect to a WTC responder, is
provided certification of coverage under
subsection (b)(2)(B)(iii); or
(ii) with respect to a screening-eligible
WTC survivor or certified-eligible WTC
survivor, is provided certification of coverage under subsection (b)(2)(B)(iii), as applied under section 300mm–32(a) of this
title.
In the case of a WTC responder described in
section 300mm–21(a)(2)(A)(ii) of this title (relating to a surviving immediate family member of a firefighter), such term does not include an illness or health condition described
in subparagraph (A)(i).
(2) Determination
The determination under paragraph (1) or
subsection (b) of whether the September 11,
2001, terrorist attacks were substantially likely to be a significant factor in aggravating,
contributing to, or causing an individual’s illness or health condition shall be made based
on an assessment of the following:
(A) The individual’s exposure to airborne
toxins, any other hazard, or any other adverse condition resulting from the terrorist
attacks. Such exposure shall be—
(i) evaluated and characterized through
the use of a standardized, population-appropriate questionnaire approved by the
Director of the National Institute for Occupational Safety and Health; and
(ii) assessed and documented by a medical professional with experience in treating or diagnosing health conditions included on the list of WTC-related health
conditions.
(B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall
be—
(i) assessed through the use of a standardized, population-appropriate medical
questionnaire approved by the Director of
the National Institute for Occupational
Safety and Health and a medical examination; and
(ii) diagnosed and documented by a medical professional described in subparagraph
(A)(ii).
(3) List of health conditions for WTC responders
The list of health conditions for WTC responders consists of the following:
(A) Aerodigestive disorders
(i) Interstitial lung diseases.
(ii) Chronic respiratory disorder—fumes/
vapors.
(iii) Asthma.
(iv) Reactive airways dysfunction syndrome (RADS).

Page 1397

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(v) WTC-exacerbated chronic obstructive
pulmonary disease (COPD).
(vi) Chronic cough syndrome.
(vii) Upper airway hyperreactivity.
(viii) Chronic rhinosinusitis.
(ix) Chronic nasopharyngitis.
(x) Chronic laryngitis.
(xi) Gastroesophageal reflux disorder
(GERD).
(xii) Sleep apnea exacerbated by or related
to a condition described in a previous clause.
(B) Mental health conditions
(i) Posttraumatic stress disorder (PTSD).
(ii) Major depressive disorder.
(iii) Panic disorder.
(iv) Generalized anxiety disorder.
(v) Anxiety disorder (not otherwise specified).
(vi) Depression (not otherwise specified).
(vii) Acute stress disorder.
(viii) Dysthymic disorder.
(ix) Adjustment disorder.
(x) Substance abuse.
(C) Musculoskeletal disorders for certain
WTC responders
In the case of a WTC responder described
in paragraph (4), a condition described in
such paragraph.
(D) Additional conditions
Any cancer (or type of cancer) or other
condition added, pursuant to paragraph (5)
or (6), to the list under this paragraph.
(4) Musculoskeletal disorders
(A) In general
For purposes of this subchapter, in the
case of a WTC responder who received any
treatment for a WTC-related musculoskeletal disorder on or before September 11,
2003, the list of health conditions in paragraph (3) shall include:
(i) Low back pain.
(ii) Carpal tunnel syndrome (CTS).
(iii) Other musculoskeletal disorders.
(B) Definition
The term ‘‘WTC-related musculoskeletal
disorder’’ means a chronic or recurrent disorder of the musculoskeletal system caused
by heavy lifting or repetitive strain on the
joints or musculoskeletal system occurring
during rescue or recovery efforts in the New
York City disaster area in the aftermath of
the September 11, 2001, terrorist attacks.
(5) Cancer
(A) In general
The WTC Program Administrator shall periodically conduct a review of all available
scientific and medical evidence, including
findings and recommendations of Clinical
Centers of Excellence, published in peer-reviewed journals to determine if, based on
such evidence, cancer or a certain type of
cancer should be added to the applicable list
of WTC-related health conditions. The WTC
Program Administrator shall conduct the
first review under this subparagraph not
later than 180 days after January 2, 2011.

§ 300mm–22

(B) Proposed regulations and rulemaking
Based on the periodic reviews under subparagraph (A), if the WTC Program Administrator determines that cancer or a certain
type of cancer should be added to such list of
WTC-related health conditions, the WTC
Program Administrator shall propose regulations, through rulemaking, to add cancer
or the certain type of cancer to such list.
(C) Final regulations
Based on all the available evidence in the
rulemaking record, the WTC Program Administrator shall make a final determination of whether cancer or a certain type of
cancer should be added to such list of WTCrelated health conditions. If such a determination is made to make such an addition,
the WTC Program Administrator shall by
regulation add cancer or the certain type of
cancer to such list.
(D) Determinations not to add cancer or certain types of cancer
In the case that the WTC Program Administrator determines under subparagraph (B)
or (C) that cancer or a certain type of cancer
should not be added to such list of WTC-related health conditions, the WTC Program
Administrator shall publish an explanation
for such determination in the Federal Register. Any such determination to not make
such an addition shall not preclude the addition of cancer or the certain type of cancer
to such list at a later date.
(6) Addition of health conditions to list for
WTC responders
(A) In general
Whenever the WTC Program Administrator determines that a proposed rule
should be promulgated to add a health condition to the list of health conditions in
paragraph (3), the Administrator may request a recommendation of the Advisory
Committee or may publish such a proposed
rule in the Federal Register in accordance
with subparagraph (D).
(B) Administrator’s options after receipt of
petition
In the case that the WTC Program Administrator receives a written petition by an interested party to add a health condition to
the list of health conditions in paragraph (3),
not later than 60 days after the date of receipt of such petition the Administrator
shall—
(i) request a recommendation of the Advisory Committee;
(ii) publish a proposed rule in the Federal Register to add such health condition,
in accordance with subparagraph (D);
(iii) publish in the Federal Register the
Administrator’s determination not to publish such a proposed rule and the basis for
such determination; or
(iv) publish in the Federal Register a determination that insufficient evidence exists to take action under clauses (i)
through (iii).

§ 300mm–22

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(C) Action by Advisory Committee
In the case that the Administrator requests a recommendation of the Advisory
Committee under this paragraph, with respect to adding a health condition to the list
in paragraph (3), the Advisory Committee
shall submit to the Administrator such recommendation not later than 60 days after
the date of such request or by such date (not
to exceed 180 days after such date of request)
as specified by the Administrator. Not later
than 60 days after the date of receipt of such
recommendation, the Administrator shall,
in accordance with subparagraph (D), publish in the Federal Register a proposed rule
with respect to such recommendation or a
determination not to propose such a proposed rule and the basis for such determination.
(D) Publication
The WTC Program Administrator shall,
with respect to any proposed rule under this
paragraph—
(i) publish such proposed rule in accordance with section 553 of title 5; and
(ii) provide interested parties a period of
30 days after such publication to submit
written comments on the proposed rule.
The WTC Program Administrator may extend the period described in clause (ii) upon
a finding of good cause. In the case of such
an extension, the Administrator shall publish such extension in the Federal Register.
(E) Interested party defined
For purposes of this paragraph, the term
‘‘interested party’’ includes a representative
of any organization representing WTC responders, a nationally recognized medical
association, a Clinical or Data Center, a
State or political subdivision, or any other
interested person.
(b) Coverage of treatment for WTC-related
health conditions
(1) Determination for enrolled WTC responders
based on a WTC-related health condition
(A) In general
If a physician at a Clinical Center of Excellence that is providing monitoring benefits under section 300mm–21 of this title for
an enrolled WTC responder makes a determination that the responder has a WTC-related health condition that is in the list in
subsection (a)(3) and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 1, 2001,
terrorist attacks is substantially likely to
be a significant factor in aggravating, contributing to, or causing the condition—
(i) the physician shall promptly transmit
such determination to the WTC Program
Administrator and provide the Administrator with the medical facts supporting
such determination; and
(ii) on and after the date of such transmittal and subject to subparagraph (B),
the WTC Program shall provide for payment under subsection (c) for medically
necessary treatment for such condition.

Page 1398

(B) Review; certification; appeals
(i) Review
A Federal employee designated by the
WTC Program Administrator shall review
determinations made under subparagraph
(A).
(ii) Certification
The Administrator shall provide a certification of such condition based upon reviews conducted under clause (i). Such a
certification shall be provided unless the
Administrator determines that the responder’s condition is not a WTC-related
health condition in the list in subsection
(a)(3) or that exposure to airborne toxins,
other hazards, or adverse conditions resulting from the September 1, 2001, terrorist attacks is not substantially likely to be
a significant factor in aggravating, contributing to, or causing the condition.
(iii) Appeal process
The Administrator shall establish, by
rule, a process for the appeal of determinations under clause (ii).
(2) Determination based on medically associated WTC-related health conditions
(A) In general
If a physician at a Clinical Center of Excellence determines pursuant to subsection
(a) that the enrolled WTC responder has a
health condition described in subsection
(a)(1)(A) that is not in the list in subsection
(a)(3) but which is medically associated with
a WTC-related health condition—
(i) the physician shall promptly transmit
such determination to the WTC Program
Administrator and provide the Administrator with the facts supporting such determination; and
(ii) the Administrator shall make a determination under subparagraph (B) with
respect to such physician’s determination.
(B) Procedures for review, certification, and
appeal
The WTC Program Administrator shall, by
rule, establish procedures for the review and
certification of physician determinations
under subparagraph (A). Such rule shall provide for—
(i) the timely review of such a determination by a physician panel with appropriate expertise for the condition and recommendations to the WTC Program Administrator;
(ii) not later than 60 days after the date
of the transmittal under subparagraph
(A)(i), a determination by the WTC Program Administrator on whether or not the
condition involved is described in subsection (a)(1)(A) and is medically associated with a WTC-related health condition;
(iii) certification in accordance with
paragraph (1)(B)(ii) of coverage of such
condition if determined to be described in
subsection (a)(1)(A) and medically associated with a WTC-related health condition;
and

Page 1399

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(iv) a process for appeals of determinations relating to such conditions.
(C) Inclusion in list of health conditions
If the WTC Program Administrator provides certification under subparagraph
(B)(iii) for coverage of a condition, the Administrator may, pursuant to subsection
(a)(6), add the condition to the list in subsection (a)(3).
(D) Conditions already declined for inclusion
in list
If the WTC Program Administrator publishes a determination under subsection
(a)(6)(B) not to include a condition in the
list in subsection (a)(3), the WTC Program
Administrator shall not provide certification under subparagraph (B)(iii) for coverage of the condition. In the case of an individual who is certified under subparagraph
(B)(iii) with respect to such condition before
the date of the publication of such determination the previous sentence shall not
apply.
(3) Requirement of medical necessity
(A) In general
In providing treatment for a WTC-related
health condition, a physician or other provider shall provide treatment that is medically necessary and in accordance with medical treatment protocols established under
subsection (d).
(B) Regulations relating to medical necessity
For the purpose of this subchapter, the
WTC Program Administrator shall issue regulations specifying a standard for determining medical necessity with respect to health
care services and prescription pharmaceuticals, a process for determining whether
treatment furnished and pharmaceuticals
prescribed under this subchapter meet such
standard (including any prior authorization
requirement), and a process for appeal of a
determination under subsection (c)(3).
(4) Scope of treatment covered
(A) In general
The scope of treatment covered under this
subsection includes services of physicians
and other health care providers, diagnostic
and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and
other medically necessary treatment.
(B) Pharmaceutical coverage
With respect to ensuring coverage of medically necessary outpatient prescription
drugs, such drugs shall be provided, under
arrangements made by the WTC Program
Administrator, directly through participating Clinical Centers of Excellence or through
one or more outside vendors.
(C) Transportation expenses for nationwide
network
The WTC Program Administrator may provide for necessary and reasonable transportation and expenses incident to the securing
of medically necessary treatment through
the nationwide network under section

§ 300mm–22

300mm–23 of this title involving travel of
more than 250 miles and for which payment
is made under this section in the same manner in which individuals may be furnished
necessary and reasonable transportation and
expenses incident to services involving travel of more than 250 miles under regulations
implementing section 7384t(c) of this title.
(5) Provision of treatment pending certification
With respect to an enrolled WTC responder
for whom a determination is made by an examining physician under paragraph (1) or (2),
but for whom the WTC Program Administrator has not yet determined whether to certify the determination, the WTC Program Administrator may establish by rule a process
through which the Administrator may approve
the provision of medical treatment under this
subsection (and payment under subsection (c))
with respect to such responder and such responder’s WTC-related health condition (under
such terms and conditions as the Administrator may provide) until the Administrator
makes a decision on whether to certify the determination.
(c) Payment for initial health evaluation, monitoring, and treatment of WTC-related health
conditions
(1) Medical treatment
(A) Use of FECA payment rates
(i) In general
Subject to clause (ii):
(I) Subject to subparagraphs (B) and
(C), the WTC Program Administrator
shall reimburse costs for medically necessary treatment under this subchapter
for WTC-related health conditions according to the payment rates that would
apply to the provision of such treatment
and services by the facility under the
Federal Employees Compensation Act.
(II) For treatment not covered under
subclause (i) or subparagraph (B), the
WTC Program Administrator shall establish by regulation a reimbursement
rate for such treatment.
(ii) Exception
In no case shall payments for products or
services under clause (i) be made at a rate
higher than the Office of Worker’s Compensation Programs in the Department 1
Labor would pay for such products or services rendered at the time such products or
services were provided.
(B) Pharmaceuticals
(i) In general
The WTC Program Administrator shall
establish a program for paying for the
medically necessary outpatient prescription pharmaceuticals prescribed under this
subchapter for WTC-related health conditions through one or more contracts with
outside vendors.
(ii) Competitive bidding
Under such program the Administrator
shall—
1 So

in original. The word ‘‘of’’ probably should appear.

§ 300mm–23

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(I) select one or more appropriate vendors through a Federal competitive bid
process; and
(II) select the lowest bidder (or bidders) meeting the requirements for providing pharmaceutical benefits for participants in the WTC Program.
(iii) Treatment of FDNY participants
Under such program the Administrator
may enter into an agreement with a separate vendor to provide pharmaceutical
benefits to enrolled WTC responders for
whom the Clinical Center of Excellence is
described in section 300mm—4 of this title
if such an arrangement is deemed necessary and beneficial to the program by
the WTC Program Administrator.
(iv) Pharmaceuticals
Not later than July 1, 2011, the Comptroller General of the United States shall
submit to the Committee on Energy and
Commerce of the House of Representatives
and the Committee on Health, Education,
Labor, and Pensions of the Senate a report
on whether existing Federal pharmaceutical purchasing programs can provide
pharmaceutical benefits more efficiently
and effectively than through the WTC program.
(C) Improving quality and efficiency through
modification of payment amounts and
methodologies
The WTC Program Administrator may
modify the amounts and methodologies for
making payments for initial health evaluations, monitoring, or treatment, if, taking
into account utilization and quality data
furnished by the Clinical Centers of Excellence under section 300mm–4(b)(1)(B)(iii) of
this title, the Administrator determines
that a bundling, capitation, pay for performance, or other payment methodology would
better ensure high quality and efficient delivery of initial health evaluations, monitoring, or treatment to an enrolled WTC responder, screening-eligible WTC survivor, or
certified-eligible WTC survivor.
(2) Monitoring and initial health evaluation
The WTC Program Administrator shall reimburse the costs of monitoring and the costs
of an initial health evaluation provided under
this subchapter at a rate set by the Administrator by regulation.
(3) Determination of medical necessity
(A) Review of medical necessity and protocols
As part of the process for reimbursement
or payment under this subsection, the WTC
Program Administrator shall provide for the
review of claims for reimbursement or payment for the provision of medical treatment
to determine if such treatment is medically
necessary and in accordance with medical
treatment protocols established under subsection (d).
(B) Withholding of payment for medically unnecessary treatment
The Administrator shall withhold such reimbursement or payment for treatment that

Page 1400

the Administrator determines is not medically necessary or is not in accordance with
such medical treatment protocols.
(d) Medical treatment protocols
(1) Development
The Data Centers shall develop medical
treatment protocols for the treatment of enrolled WTC responders and certified-eligible
WTC survivors for health conditions included
in the applicable list of WTC-related health
conditions.
(2) Approval
The medical treatment protocols developed
under paragraph (1) shall be subject to approval by the WTC Program Administrator.
(July 1, 1944, ch. 373, title XXXIII, § 3312, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3639.)
REFERENCES IN TEXT
The Federal Employees Compensation Act, referred
to in subsec. (c)(1)(A)(i)(I), is act Sept. 7, 1916, ch. 458,
39 Stat. 742. The act was repealed, and the provisions
thereof were reenacted as subchapter I (§ 8101 et seq.) of
chapter 81 of Title 5, Government Organization and
Employees, by Pub. L. 89–554, Sept. 6, 1966, 80 Stat. 378.

§ 300mm–23. National arrangement for benefits
for eligible individuals outside New York
(a) In general
In order to ensure reasonable access to benefits under this part for individuals who are enrolled WTC responders, screening-eligible WTC
survivors, or certified-eligible WTC survivors
and who reside in any State, as defined in section 201(f) of this title, outside the New York
metropolitan area, the WTC Program Administrator shall establish a nationwide network of
health care providers to provide monitoring and
treatment benefits and initial health evaluations near such individuals’ areas of residence in
such States. Nothing in this subsection shall be
construed as preventing such individuals from
being provided such monitoring and treatment
benefits or initial health evaluation through
any Clinical Center of Excellence.
(b) Network requirements
Any health care provider participating in the
network under subsection (a) shall—
(1) meet criteria for credentialing established by the Data Centers;
(2) follow the monitoring, initial health
evaluation, and treatment protocols developed
under section 300mm–4(a)(2)(A)(ii) of this title;
(3) collect and report data in accordance
with section 300mm–3 of this title; and
(4) meet such fraud, quality assurance, and
other requirements as the WTC Program Administrator establishes, including sections
1320a–7 through 1320a–7e of this title, as applied by section 300mm(d) of this title.
(c) Training and technical assistance
The WTC Program Administer 1 may provide,
including through contract, for the provision of
training and technical assistance to health care
1 So

in original. Probably should be ‘‘Administrator’’.

Page 1401

TITLE 42—THE PUBLIC HEALTH AND WELFARE

providers participating in the network under
subsection (a).
(d) Provision of services through the VA
(1) In general
The WTC Program Administrator may enter
into an agreement with the Secretary of Veterans Affairs for the Secretary to provide services under this section through facilities of
the Department of Veterans Affairs.
(2) National program
Not later than July 1, 2011, the Comptroller
General of the United States shall submit to
the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health, Education, Labor, and Pensions
of the Senate a report on whether the Department of Veterans Affairs can provide monitoring and treatment services to individuals
under this section more efficiently and effectively than through the nationwide network
to be established under subsection (a).
(July 1, 1944, ch. 373, title XXXIII, § 3313, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3647.)
SUBPART 2—WTC SURVIVORS

§ 300mm–31. Identification and initial health
evaluation of screening-eligible and certifiedeligible WTC survivors
(a) Identification of screening-eligible WTC survivors and certified-eligible WTC survivors
(1) Screening-eligible WTC survivors
(A) Definition
In this subchapter, the term ‘‘screening-eligible WTC survivor’’ means, subject to subparagraph (C) and paragraph (3), an individual who is described in any of the following
clauses:
(i) Currently identified survivor
An individual, including a WTC responder, who has been identified as eligible
for medical treatment and monitoring by
the WTC Environmental Health Center as
of January 2, 2011.
(ii) Survivor who meets current eligibility
criteria
An individual who is not a WTC responder, for purposes of the initial health
evaluation under subsection (b), claims
symptoms of a WTC-related health condition and meets any of the current eligibility criteria described in subparagraph
(B).
(iii) Survivor who meets modified eligibility criteria
An individual who is not a WTC responder, for purposes of the initial health
evaluation under subsection (b), claims
symptoms of a WTC-related health condition and meets such eligibility criteria relating to exposure to airborne toxins,
other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks as the WTC Administrator determines, after consultation with the Data

§ 300mm–31

Centers described in section 300mm–4 of
this title and the WTC Scientific/Technical
Advisory Committee and WTC Health Program Steering Committees under section
300mm–1 of this title.
The Administrator shall not modify such
criteria under clause (iii) on or after the
date that the number of certifications for
certified-eligible WTC survivors under paragraph (2)(B) has reached 80 percent of the
limit described in paragraph (3) or on or
after the date that the number of enrollments of WTC responders has reached 80 percent of the limit described in section
300mm–21(a)(4) of this title.
(B) Current eligibility criteria
The eligibility criteria described in this
subparagraph for an individual are that the
individual is described in any of the following clauses:
(i) A person who was present in the New
York City disaster area in the dust or dust
cloud on September 11, 2001.
(ii) A person who worked, resided, or attended school, childcare, or adult daycare
in the New York City disaster area for—
(I) at least 4 days during the 4-month
period beginning on September 11, 2001,
and ending on January 10, 2002; or
(II) at least 30 days during the period
beginning on September 11, 2001, and
ending on July 31, 2002.
(iii) Any person who worked as a cleanup
worker or performed maintenance work in
the New York City disaster area during
the 4-month period described in subparagraph (B)(i) and had extensive exposure to
WTC dust as a result of such work.
(iv) A person who was deemed eligible to
receive a grant from the Lower Manhattan
Development
Corporation
Residential
Grant Program, who possessed a lease for
a residence or purchased a residence in the
New York City disaster area, and who resided in such residence during the period
beginning on September 11, 2001, and ending on May 31, 2003.
(v) A person whose place of employment—
(I) at any time during the period beginning on September 11, 2001, and ending
on May 31, 2003, was in the New York
City disaster area; and
(II) was deemed eligible to receive a
grant from the Lower Manhattan Development Corporation WTC Small Firms
Attraction and Retention Act program
or other government incentive program
designed to revitalize the lower Manhattan economy after the September 11,
2001, terrorist attacks.
(C) Application and determination process
for screening eligibility
(i) In general
The WTC Program Administrator in consultation with the Data Centers shall establish a process for individuals, other
than individuals described in subparagraph

§ 300mm–31

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A)(i), to be determined to be screening-eligible WTC survivors. Under such process—
(I) there shall be no fee charged to the
applicant for making an application for
such determination;
(II) the Administrator shall make a determination on such an application not
later than 60 days after the date of filing
the application;
(III) the Administrator shall make
such a determination relating to an applicant’s compliance with this subchapter and shall not determine that an
individual is not so eligible or deny written documentation under clause (ii) to
such individual unless the Administrator
determines that—
(aa) based on the application submitted, the individual does not meet the
eligibility criteria; or
(bb) the numerical limitation on certifications of certified-eligible WTC
survivors set forth in paragraph (3) has
been met; and
(IV) an individual who is determined
not to be a screening-eligible WTC survivor shall have an opportunity to appeal such determination in a manner established under such process.
(ii) Written documentation of screening-eligibility
(I) In general
In the case of an individual who is described in subparagraph (A)(i) or who is
determined under clause (i) (consistent
with paragraph (3)) to be a screening-eligible WTC survivor, the WTC Program
Administrator shall provide an appropriate written documentation of such
fact.
(II) Timing
(aa) Currently identified survivors
In the case of an individual who is
described in subparagraph (A)(i), the
WTC Program Administrator shall provide the written documentation under
subclause (I) not later than July 1,
2011.
(bb) Other members
In the case of another individual who
is determined under clause (i) and consistent with paragraph (3) to be a
screening-eligible WTC survivor, the
WTC Program Administrator shall provide the written documentation under
subclause (I) at the time of such determination.
(2) Certified-eligible WTC survivors
(A) Definition
The term ‘‘certified-eligible WTC survivor’’ means, subject to paragraph (3), a
screening-eligible WTC survivor who the
WTC Program Administrator certifies under
subparagraph (B) to be eligible for followup
monitoring and treatment under this subpart.

Page 1402

(B) Certification of eligibility for monitoring
and treatment
(i) In general
The WTC Program Administrator shall
establish a certification process under
which the Administrator shall provide appropriate certification to screening-eligible WTC survivors who, pursuant to the
initial health evaluation under subsection
(b), are determined to be eligible for followup monitoring and treatment under
this subpart.
(ii) Timing
(I) Currently identified survivors
In the case of an individual who is described in paragraph (1)(A)(i), the WTC
Program Administrator shall provide the
certification under clause (i) not later
than July 1, 2011.
(II) Other members
In the case of another individual who
is determined under clause (i) to be eligible for followup monitoring and treatment, the WTC Program Administrator
shall provide the certification under
such clause at the time of such determination.
(3) Numerical limitation on certified-eligible
WTC survivors
(A) In general
The total number of individuals not described in paragraph (1)(A)(i) who may be
certified as certified-eligible WTC survivors
under paragraph (2)(B) shall not exceed 25,000
at any time.
(B) Process
In implementing subparagraph (A), the
WTC Program Administrator shall—
(i) limit the number of certifications
provided under paragraph (2)(B)—
(I) in accordance with such subparagraph; and
(II) to such number, as determined by
the Administrator based on the best
available information and subject to
amounts made available under section
300mm–61 of this title, that will ensure
sufficient funds will be available to provide treatment and monitoring benefits
under this subchapter, with respect to
all individuals receiving such certifications through the end of fiscal year
2020; and
(ii) provide priority in such certifications in the order in which individuals
apply for a determination under paragraph
(2)(B).
(4) Disqualification of individuals on terrorist
watch list
No individual who is on the terrorist watch
list maintained by the Department of Homeland Security shall qualify as a screening-eligible WTC survivor or a certified-eligible WTC
survivor. Before determining any individual to
be a screening-eligible WTC survivor under
paragraph (1) or certifying any individual as a

Page 1403

TITLE 42—THE PUBLIC HEALTH AND WELFARE

certified eligible 1 WTC survivor under paragraph (2), the Administrator, in consultation
with the Secretary of Homeland Security,
shall determine whether the individual is on
such list.
(b) Initial health evaluation to determine eligibility for followup monitoring or treatment
(1) In general
In the case of a screening-eligible WTC survivor, the WTC Program shall provide for an
initial health evaluation to determine if the
survivor has a WTC-related health condition
and is eligible for followup monitoring and
treatment benefits under the WTC Program.
Initial health evaluation protocols under section 300mm–4(a)(2)(A)(ii) of this title shall be
subject to approval by the WTC Program Administrator.
(2) Initial health evaluation providers
The initial health evaluation described in
paragraph (1) shall be provided through a Clinical Center of Excellence with respect to the
individual involved.
(3) Limitation on initial health evaluation benefits
Benefits for an initial health evaluation
under this subpart for a screening-eligible
WTC survivor shall consist only of a single
medical initial health evaluation consistent
with initial health evaluation protocols described in paragraph (1). Nothing in this paragraph shall be construed as preventing such an
individual from seeking additional medical
initial health evaluations at the expense of
the individual.
(July 1, 1944, ch. 373, title XXXIII, § 3321, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3648.)
§ 300mm–32. Followup monitoring and treatment
of certified-eligible WTC survivors for WTCrelated health conditions
(a) In general
Subject to subsection (b), the provisions of
sections 300mm–21 and 300mm–22 of this title
shall apply to followup monitoring and treatment of WTC-related health conditions for certified-eligible WTC survivors in the same manner as such provisions apply to the monitoring
and treatment of WTC-related health conditions
for enrolled WTC responders.
(b) List of WTC-related health conditions for survivors
The list of health conditions for screening-eligible WTC survivors and certified-eligible WTC
survivors consists of the following:
(1) Aerodigestive disorders
(A) Interstitial lung diseases.
(B) Chronic respiratory disorder—fumes/vapors.
(C) Asthma.
(D) Reactive airways dysfunction syndrome
(RADS).
(E) WTC-exacerbated chronic obstructive
pulmonary disease (COPD).
1 So

in original. Probably should be ‘‘certified-eligible’’.

§ 300mm–33

(F) Chronic cough syndrome.
(G) Upper airway hyperreactivity.
(H) Chronic rhinosinusitis.
(I) Chronic nasopharyngitis.
(J) Chronic laryngitis.
(K)
Gastroesophageal
reflux
disorder
(GERD).
(L) Sleep apnea exacerbated by or related to
a condition described in a previous clause.
(2) Mental health conditions
(A) Posttraumatic stress disorder (PTSD).
(B) Major depressive disorder.
(C) Panic disorder.
(D) Generalized anxiety disorder.
(E) Anxiety disorder (not otherwise specified).
(F) Depression (not otherwise specified).
(G) Acute stress disorder.
(H) Dysthymic disorder.
(I) Adjustment disorder.
(J) Substance abuse.
(3) Additional conditions
Any cancer (or type of cancer) or other condition
added
to
the
list
in
section
300mm–22(a)(3) of this title pursuant to paragraph (5) or (6) of section 300mm–22(a) of this
title, as such provisions are applied under subsection (a) with respect to certified-eligible
WTC survivors.
(July 1, 1944, ch. 373, title XXXIII, § 3322, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3652.)
§ 300mm–33. Followup monitoring and treatment
of other individuals with WTC-related health
conditions
(a) In general
Subject to subsection (c), the provisions of
section 300mm–32 of this title shall apply to the
followup monitoring and treatment of WTC-related health conditions in the case of individuals
described in subsection (b) in the same manner
as such provisions apply to the followup monitoring and treatment of WTC-related health
conditions for certified-eligible WTC survivors.
(b) Individuals described
An individual described in this subsection is
an individual who, regardless of location of residence—
(1) is not an enrolled WTC responder or a
certified-eligible WTC survivor; and
(2) is diagnosed at a Clinical Center of Excellence with a WTC-related health condition for
certified-eligible WTC survivors.
(c) Limitation
(1) In general
The WTC Program Administrator shall limit
benefits for any fiscal year under subsection
(a) in a manner so that payments under this
section for such fiscal year do not exceed the
amount specified in paragraph (2) for such fiscal year.
(2) Limitation
The amount specified in this paragraph for—
(A) the last calendar quarter of fiscal year
2011 is $5,000,000;

§ 300mm–41

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) fiscal year 2012 is $20,000,000; or
(C) a succeeding fiscal year is the amount
specified in this paragraph for the previous
fiscal year increased by the annual percentage increase in the medical care component
of the consumer price index for all urban
consumers.
(July 1, 1944, ch. 373, title XXXIII, § 3323, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3652.)
SUBPART 3—PAYOR PROVISIONS

§ 300mm–41. Payment of claims
(a) In general
Except as provided in subsections (b) and (c),
the cost of monitoring and treatment benefits
and initial health evaluation benefits provided
under subparts 1 and 2 of this part shall be paid
for by the WTC Program from the World Trade
Center Health Program Fund.
(b) Workers’ compensation payment
(1) In general
Subject to paragraph (2), payment for treatment under subparts 1 and 2 of this part of a
WTC-related health condition of an individual
that is work-related shall be reduced or recouped to the extent that the WTC Program
Administrator determines that payment has
been made, or can reasonably be expected to
be made, under a workers’ compensation law
or plan of the United States, a State, or a locality, or other work-related injury or illness
benefit plan of the employer of such individual, for such treatment. The provisions of
clauses (iii), (iv), (v), and (vi) of paragraph
(2)(B) of section 1862(b) of the Social Security
Act [42 U.S.C. 1395y(b)] and paragraphs (3) and
(4) of such section shall apply to the
recoupment under this subsection of a payment to the WTC Program (with respect to a
workers’ compensation law or plan, or other
work-related injury or illness plan of the employer involved, and such individual) in the
same manner as such provisions apply to the
reimbursement of a payment under section
1862(b)(2) of such Act [42 U.S.C. 1395y(b)(2)] to
the Secretary (with respect to such a law or
plan and an individual entitled to benefits
under title XVIII of such Act [42 U.S.C. 1395 et
seq.]) except that any reference in such paragraph (4) to payment rates under title XVIII of
the Social Security Act shall be deemed a reference to payment rates under this subchapter.
(2) Exception
Paragraph (1) shall not apply for any quarter, with respect to any workers’ compensation law or plan, including line of duty compensation, to which New York City is obligated to make payments, if, in accordance
with terms specified under the contract under
subsection (d)(1)(A), New York City has made
the full payment required under such contract
for such quarter.
(3) Rules of construction
Nothing in this subchapter shall be construed to affect, modify, or relieve any obliga-

Page 1404

tions under a worker’s compensation law or
plan, other work-related injury or illness benefit plan of an employer, or any health insurance plan.
(c) Health insurance coverage
(1) In general
In the case of an individual who has a WTCrelated health condition that is not work-related and has health coverage for such condition through any public or private health plan
(including health benefits under title XVIII,
XIX, or XXI of the Social Security Act [42
U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.])
the provisions of section 1862(b) of the Social
Security Act [42 U.S.C. 1395y(b)] shall apply to
such a health plan and such individual in the
same manner as they apply to group 1 health
plan and an individual entitled to benefits
under title XVIII of such Act pursuant to section 226(a) of such Act [42 U.S.C. 426(a)]. Any
costs for items and services covered under
such plan that are not reimbursed by such
health plan, due to the application of deductibles, copayments, coinsurance, other cost
sharing, or otherwise, are reimbursable under
this subchapter to the extent that they are
covered under the WTC Program. The program
under this subchapter shall not be treated as a
legally liable party for purposes of applying
section 1902(a)(25) of the Social Security Act
[42 U.S.C. 1396a(a)(25)].
(2) Recovery by individual providers
Nothing in paragraph (1) shall be construed
as requiring an entity providing monitoring
and treatment under this subchapter to seek
reimbursement under a health plan with
which the entity has no contract for reimbursement.
(3) Maintenance of required minimum essential coverage
No payment may be made for monitoring
and treatment under this subchapter for an individual for a month (beginning with July
2014) if with respect to such month the individual—
(A) is an applicable individual (as defined
in subsection (d) of section 5000A of title 26)
for whom the exemption under subsection (e)
of such section does not apply; and
(B) is not covered under minimum essential coverage, as required under subsection
(a) of such section.
(d) Required contribution by New York City in
program costs
(1) Contract requirement
(A) In general
No funds may be disbursed from the World
Trade Center Health Program Fund under
section 300mm–61 of this title unless New
York City has entered into a contract with
the WTC Program Administrator under
which New York City agrees, in a form and
manner specified by the Administrator, to
pay the full contribution described in subparagraph (B) in accordance with this sub1 So

in original. Probably should be preceded by ‘‘a’’.

Page 1405

TITLE 42—THE PUBLIC HEALTH AND WELFARE

section on a timely basis, plus any interest
owed pursuant to subparagraph (E)(i). Such
contract shall specify the terms under which
New York City shall be considered to have
made the full payment required for a quarter
for purposes of subsection (b)(2).
(B) Full contribution amount
Under such contract, with respect to the
last calendar quarter of fiscal year 2011 and
each calendar quarter in fiscal years 2012
through 2015 the full contribution amount
under this subparagraph shall be equal to 10
percent of the expenditures in carrying out
this subchapter for the respective quarter
and with respect to calendar quarters in fiscal year 2016, such full contribution amount
shall be equal to 1⁄9 of the Federal expenditures in carrying out this subchapter for the
respective quarter.
(C) Satisfaction of payment obligation
The payment obligation under such contract may not be satisfied through any of
the following:
(i) An amount derived from Federal
sources.
(ii) An amount paid before January 2,
2011.
(iii) An amount paid to satisfy a judgment or as part of a settlement related to
injuries or illnesses arising out of the September 11, 2001, terrorist attacks.
(D) Timing of contribution
The payment obligation under such contract for a calendar quarter in a fiscal year
shall be paid not later than the last day of
the second succeeding calendar quarter.
(E) Compliance
(i) Interest for late payment
If New York City fails to pay to the WTC
Program Administrator pursuant to such
contract the amount required for any calendar quarter by the day specified in subparagraph (D), interest shall accrue on the
amount not so paid at the rate (determined by the Administrator) based on the
average yield to maturity, plus 1 percentage point, on outstanding municipal bonds
issued by New York City with a remaining
maturity of at least 1 year.
(ii) Recovery of amounts owed
The amounts owed to the WTC Program
Administrator under such contract shall
be recoverable by the United States in an
action in the same manner as payments
made under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] may be recoverable in an action brought under section 1862(b)(2)(B)(iii) of such Act [42 U.S.C.
1395y(b)(2)(B)(iii)].
(F) Deposit in fund
The WTC Program Administer shall deposit amounts paid under such contract into
the World Trade Center Health Program
Fund under section 300mm–61 of this title.
(2) Payment of New York City share of monitoring and treatment costs
With respect to each calendar quarter for
which a contribution is required by New York

§ 300mm–42

City under the contract under paragraph (1),
the WTC Program Administrator shall—
(A) provide New York City with an estimate of such amount of the required contribution at the beginning of such quarter
and with an updated estimate of such
amount at the beginning of each of the subsequent 2 quarters;
(B) bill such amount directly to New York
City; and
(C) certify periodically, for purposes of
this subsection, whether or not New York
City has paid the amount so billed.
Such amount shall initially be estimated by
the WTC Program Administrator and shall be
subject to adjustment and reconciliation based
upon actual expenditures in carrying out this
subchapter.
(3) Rule of construction
Nothing in this subsection shall be construed as authorizing the WTC Administrator,
with respect to a fiscal year, to reduce the numerical
limitation
under
section
300mm–21(a)(4) or 300mm–31(a)(3) of this title
for such fiscal year if New York City fails to
comply with paragraph (1) for a calendar quarter in such fiscal year.
(e) Work-related described
For the purposes of this section, a WTC-related health condition shall be treated as a condition that is work-related if—
(1) the condition is diagnosed in an enrolled
WTC responder, or in an individual who qualifies as a certified-eligible WTC survivor on the
basis of being a rescue, recovery, or cleanup
worker; or
(2) with respect to the condition the individual has filed and had established a claim under
a workers’ compensation law or plan of the
United States or a State, or other work-related injury or illness benefit plan of the employer of such individual.
(July 1, 1944, ch. 373, title XXXIII, § 3331, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3653.)
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (b)(1),
(c)(1), and (d)(1)(E)(ii), is act Aug. 14, 1935, ch. 531, 49
Stat. 620. Titles XVIII, XIX, and XXI of the Act are
classified generally to subchapters XVIII (§ 1395 et seq.),
XIX (§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
title and Tables.

§ 300mm–42. Administrative arrangement authority
The WTC Program Administrator may enter
into arrangements with other government agencies, insurance companies, or other third-party
administrators to provide for timely and accurate processing of claims under sections
300mm–22, 300mm–23, 300mm–32, and 300mm–33 of
this title.
(July 1, 1944, ch. 373, title XXXIII, § 3332, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3656.)

§ 300mm–51

TITLE 42—THE PUBLIC HEALTH AND WELFARE

PART C—RESEARCH INTO CONDITIONS
§ 300mm–51. Research regarding certain health
conditions related to September 11 terrorist
attacks
(a) In general
With respect to individuals, including enrolled
WTC responders and certified-eligible WTC survivors, receiving monitoring or treatment under
part B, the WTC Program Administrator shall
conduct or support—
(1) research on physical and mental health
conditions that may be related to the September 11, 2001, terrorist attacks;
(2) research on diagnosing WTC-related
health conditions of such individuals, in the
case of conditions for which there has been diagnostic uncertainty; and
(3) research on treating WTC-related health
conditions of such individuals, in the case of
conditions for which there has been treatment
uncertainty.
The Administrator may provide such support
through continuation and expansion of research
that was initiated before January 2, 2011, and
through the World Trade Center Health Registry
(referred to in section 300mm–52 of this title),
through a Clinical Center of Excellence, or
through a Data Center.
(b) Types of research
The research under subsection (a)(1) shall include epidemiologic and other research studies
on WTC-related health conditions or emerging
conditions—
(1) among enrolled WTC responders and certified-eligible WTC survivors under treatment;
and
(2) in sampled populations outside the New
York City disaster area in Manhattan as far
north as 14th Street and in Brooklyn, along
with control populations, to identify potential
for long-term adverse health effects in less exposed populations.
(c) Consultation
The WTC Program Administrator shall carry
out this section in consultation with the WTC
Scientific/Technical Advisory Committee.
(d) Application of privacy and human subject
protections
The privacy and human subject protections
applicable to research conducted under this section shall not be less than such protections applicable to research conducted or funded by the
Department of Health and Human Services.
(July 1, 1944, ch. 373, title XXXIII, § 3341, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3656.)
§ 300mm–52. World Trade Center Health Registry
For the purpose of ensuring ongoing data collection relating to victims of the September 11,
2001, terrorist attacks, the WTC Program Administrator shall ensure that a registry of such
victims is maintained that is at least as comprehensive as the World Trade Center Health Registry maintained under the arrangements in effect as of April 20, 2009, with the New York City
Department of Health and Mental Hygiene.

Page 1406

(July 1, 1944, ch. 373, title XXXIII, § 3342, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3657.)
PART D—FUNDING
§ 300mm–61. World Trade Center Health Program
Fund
(a) Establishment of Fund
(1) In general
There is established a fund to be known as
the World Trade Center Health Program Fund
(referred to in this section as the ‘‘Fund’’).
(2) Funding
Out of any money in the Treasury not otherwise appropriated, there shall be deposited
into the Fund for each of fiscal years 2012
through 2016 (and the last calendar quarter of
fiscal year 2011)—
(A) the Federal share, consisting of an
amount equal to the lesser of—
(i) 90 percent of the expenditures in carrying out this subchapter for the respective fiscal year (initially based on estimates, subject to subsequent reconciliation based on actual expenditures); or
(ii)(I) $71,000,000 for the last calendar
quarter of fiscal year 2011, $318,000,000 for
fiscal year 2012, $354,000,000 for fiscal year
2013, $382,000,000 for fiscal year 2014, and
$431,000,000 for fiscal year 2015; and
(II) subject to paragraph (4), an additional amount for fiscal year 2016 from unexpended amounts for previous fiscal
years; plus
(B) the New York City share, consisting of
the amount contributed under the contract
under section 300mm–41(d) of this title.
(3) Contract requirement
(A) In general
No funds may be disbursed from the Fund
unless New York City has entered into a
contract with the WTC Program Administrator under section 300mm–41(d)(1) of this
title.
(B) Breach of contract
In the case of a failure to pay the amount
so required under the contract—
(i) the amount is recoverable under subparagraph (E)(ii) of such section;
(ii) such failure shall not affect the disbursement of amounts from the Fund; and
(iii) the Federal share described in paragraph (2)(A) shall not be increased by the
amount so unpaid.
(4) Aggregate limitation on funding beginning
with fiscal year 2016
Beginning with fiscal year 2016, in no case
shall the share of Federal funds deposited into
the Fund under paragraph (2) for such fiscal
year and previous fiscal years and quarters exceed the sum of the amounts specified in paragraph (2)(A)(ii)(I).
(b) Mandatory funds for monitoring, initial
health evaluations, treatment, and claims
processing
(1) In general
The amounts deposited into the Fund under
subsection (a)(2) shall be available, without

Page 1407

TITLE 42—THE PUBLIC HEALTH AND WELFARE

further appropriation, consistent with paragraph (2) and subsection (c), to carry out part
B and sections 300mm–1(a), 300mm–2, 300mm–3,
300mm–4(a)(2), 300mm–4(c), 300mm–51, and
300mm–52 of this title.
(2) Limitation on mandatory funding
This subchapter does not establish any Federal obligation for payment of amounts in excess of the amounts available from the Fund
for such purpose.
(3) Limitation on authorization for further appropriations
This subchapter does not establish any authorization for appropriation of amounts in
excess of the amounts available from the Fund
under paragraph (1).
(c) Limits on spending for certain purposes
Of the amounts made available under subsection (b)(1), not more than each of the following amounts may be available for each of the
following purposes:
(1) Surviving immediate family members of
firefighters
For the purposes of carrying out part B with
respect to WTC responders described in section
300mm–21(a)(2)(A)(ii) of this title—
(A) for the last calendar quarter of fiscal
year 2011, $100,000;
(B) for fiscal year 2012, $400,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(2) WTC Health Program Scientific/Technical
Advisory Committee
For the purpose of carrying out section
300mm–1(a) of this title—
(A) for the last calendar quarter of fiscal
year 2011, $25,000;
(B) for fiscal year 2012, $100,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(3) Education and outreach
For the purpose of carrying out section
300mm–2 of this title—
(A) for the last calendar quarter of fiscal
year 2011, $500,000;
(B) for fiscal year 2012, $2,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(4) Uniform data collection
For the purpose of carrying out section
300mm–3 of this title and for reimbursing Data

Centers (as defined in section 300mm–4(b)(2) of
this title) for the costs incurred by such Centers in carrying out activities under contracts
entered into under section 300mm–4(a)(2) of
this title—
(A) for the last calendar quarter of fiscal
year 2011, $2,500,000;
(B) for fiscal year 2012, $10,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(5) Research regarding certain health conditions
For the purpose of carrying out section
300mm–51 of this title—
(A) for the last calendar quarter of fiscal
year 2011, $3,750,000;
(B) for fiscal year 2012, $15,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(6) World Trade Center Health Registry
For the purpose of carrying out section
300mm–52 of this title—
(A) for the last calendar quarter of fiscal
year 2011, $1,750,000;
(B) for fiscal year 2012, $7,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for
the previous fiscal year increased by the percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending
with March of the previous year.
(July 1, 1944, ch. 373, title XXXIII, § 3351, as
added Pub. L. 111–347, title I, § 101, Jan. 2, 2011,
124 Stat. 3657.)
CHAPTER 7—SOCIAL SECURITY
SUBCHAPTER I—GRANTS TO STATES FOR OLDAGE ASSISTANCE
Sec.

301.
302.
303.

304.

305.
306.

Authorization of appropriations.
State old-age plans.
Payments to States and certain territories; computation of amount; eligibility of State to receive payment.
Stopping payment on deviation from required provisions of plan or failure to
comply therewith.
Omitted.
Definitions.

SUBCHAPTER
II—FEDERAL
OLD-AGE,
SURVIVORS, AND DISABILITY INSURANCE BENEFITS
401.
401a.
402.

Trust Funds.
Omitted.
Old-age and survivors insurance benefit
payments.