Authorizing Legislation

BioSense – Request for Revision
Attachment 1

Public Health Service Act
(42 U.S.C 241, 247b and 247d-4)
Pandemic and All-Hazards Preparedness Act
(Public Law 109-417)

Public Health Service Act
42 U.S.C. 241, 247b and 247d-4
Excerpted from: U.S. Code TITLE 42--THE PUBLIC HEALTH AND WELFARE; CHAPTER
6A--PUBLIC HEALTH SERVICE; SUBCHAPTER II--GENERAL POWERS AND DUTIES;
Part A--Research and Investigations
Sec. 241. Research and investigations generally
(a) Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance
to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and
promote the coordination of, research, investigations, experiments, demonstrations, and studies
relating to the causes, diagnosis, treatment, control, and prevention of physical and mental
diseases and impairments of man, including water purification, sewage treatment, and
pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to-(1) collect and make available through publications and other appropriate means,
information as to, and the practical application of, such research and other activities;
(2) make available research facilities of the Service to appropriate public authorities,
and to health officials and scientists engaged in special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or
private institutions, and to individuals for such research projects as are recommended by
the advisory council to the entity of the Department supporting such projects and make,
upon recommendation of the advisory council to the appropriate entity of the
Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and
other institutions for the general support of their research;
(4) secure from time to time and for such periods as he deems advisable, the assistance
and advice of experts, scholars, and consultants from the United States or abroad;
(5) for purposes of study, admit and treat at institutions, hospitals, and stations of the
Service, persons not otherwise eligible for such treatment;
(6) make available, to health officials, scientists, and appropriate public and other
nonprofit institutions and organizations, technical advice and assistance on the
application of statistical methods to experiments, studies, and surveys in health and
medical fields;
(7) enter into contracts, including contracts for research in accordance with and subject
to the provisions of law applicable to contracts entered into by the military departments
under sections 2353 and 2354 of title 10, except that determination, approval, and
certification required thereby shall be by the Secretary of Health and Human Services;
and
(8) adopt, upon recommendations of the advisory councils to the appropriate entities of
the Department or, with respect to mental health, the National Advisory Mental Health
Council, such additional means as the Secretary considers necessary or appropriate to
carry out the purposes of this section. The Secretary may make available to individuals
and entities, for biomedical and behavioral research, substances and living organisms.

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

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provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and
each such other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any contract for the conduct of any study,
testing, program, research, or review, or assessment under this subsection shall be effective for
any fiscal year only to such extent or in such amounts as are provided in advance in
appropriation Acts.
(c) Diseases not significantly occurring in United States
The Secretary may conduct biomedical research, directly or through grants or contracts, for the
identification, control, treatment, and prevention of diseases (including tropical diseases) which
do not occur to a significant extent in the United States.
(d) Protection of privacy of individuals who are research subjects
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other
research (including research on mental health, including research on the use and effect of alcohol
and other psychoactive drugs) to protect the privacy of individuals who are the subject of such
research by withholding from all persons not connected with the conduct of such research the
names or other identifying characteristics of such individuals. Persons so authorized to protect
the privacy of such individuals may not be compelled in any Federal, State, or local civil,
criminal, administrative, legislative, or other proceedings to identify such individuals.
Excerpted from: U.S. Code TITLE 42--THE PUBLIC HEALTH AND WELFARE; CHAPTER
6A--PUBLIC HEALTH SERVICE; SUBCHAPTER II--GENERAL POWERS AND DUTIES;
Part B—Federal-State Cooperation
Section 247b. Project grants for preventive health services
(a) Grant authority
The Secretary may make grants to States, and in consultation with State health authorities, to
political subdivisions of States and to other public entities to assist them in meeting the costs of
establishing and maintaining preventive health service programs.
(b) Application
No grant may be made under subsection (a) of this section unless an application therefore has
been submitted to, and approved by, the Secretary. Such an application shall be in such form and
be submitted in such manner as the Secretary shall by regulation prescribe and shall provide –
(1) a complete description of the type and extent of the program for which the applicant is
seeking a grant under subsection (a) of this section;
(2) with respect to each such program
(A) the amount of Federal, State, and other funds obligated by the applicant in
its latest annual accounting period for the provision of such program, (B) a
description of the services provided by the applicant in such program in such
period,
(C) the amount of Federal funds needed by the applicant to continue providing
such services in such program, and

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(D) if the applicant proposes changes in the provision of the services in such
program, the priorities of such proposed changes, reasons for such changes, and
the amount of Federal funds needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with
funds under a grant under subsection (a) of this section will be provided in a manner
consistent with the State health plan in effect under section 300m-3(c) (!1) of this title
and in those cases where the applicant is a State, that such program will be provided,
where appropriate, in a manner consistent with any plans in effect under an application
approved under section 247 (!1) of this title;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal
control and fund accounting procedures as the Secretary by regulation prescribes to
assure the proper disbursement of and accounting for funds received under grants under
subsection (a) of this section;
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic
evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in
such form and containing such information as the Secretary may by regulation prescribe)
as the Secretary may reasonably require and keep such records and afford such access
thereto as the Secretary may find necessary to assure the correctness of, and to verify,
such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other
conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) of this section
for a grant for a program for which a grant was previously made under subsection (a) of this
section unless the Secretary determines (A) the program for which the application was submitted is operating effectively to
achieve its stated purpose,
(B) the applicant complied with the assurances provided the Secretary when applying for
such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant
under subsection (a) of this section to determine if the program assisted by such grant is
operating effectively to achieve its stated purposes and if the recipient is in compliance with the
assurances provided the Secretary when applying for such grant.
(d) Amount of grant; payment
The amount of a grant under subsection (a) of this section shall be determined by the Secretary.
Payments under such grants may be made in advance on the basis of estimates or by the way of
reimbursement, with necessary adjustments on account of underpayments or overpayments, and
in such installments and on such terms and conditions as the Secretary finds necessary to carry
out the purposes of such grants.
(e) Reduction

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The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may
reduce the amount of such grant by (1) the fair market value of any supplies (including vaccines and other preventive agents)
or equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of
the Government when detailed to the grant recipient and the amount of any other costs
incurred in connection with the detail of such officer or employee, when the furnishing of
such supplies or equipment or the detail of such an officer or employee is for the
convenience of and at the request of such grant recipient and for the purpose of carrying
out a program with respect to which the grant under subsection (a) of this section is
made. The amount by which any such grant is so reduced shall be available for payment
by the Secretary of the costs incurred in furnishing the supplies or equipment, or in
detailing the personnel, on which the reduction of such grant is based, and such amount
shall be deemed as part of the grant and shall be deemed to have been paid to the grant
recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection (a) of this section shall keep such records
as the Secretary shall by regulation prescribe, including records which fully disclose the
amount and disposition by such recipient of the proceeds of such grant, the total cost of
the undertaking in connection with which such grant was made, and the amount of that
portion of the cost of the undertaking supplied by other sources, and such other records as
will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly
authorized representatives, shall have access for the purpose of audit and examination to
any books, documents, papers, and records of the recipient of grants under subsection (a)
of this section that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment prohibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are
granted to a State or to an agency or a political subdivision of a State under provisions of
Federal law (other than this section) and which are available for the conduct of preventive
health service programs from being used in connection with programs assisted through
grants under subsection (a) of this section.
(2) Nothing in this section shall be construed to require any State or any agency or
political subdivision of a State to have a preventive health service program which would
require any person, who objects to any treatment provided under such a program, to be
treated or to have any child or ward treated under such program.
(h) Reports
The Secretary shall include, as part of the report required by section 300u-4 of this title, a report
on the extent of the problems presented by the diseases and conditions referred to in subsection
(j) of this section; on the amount of funds obligated under grants under subsection (a) of this
section in the preceding fiscal year for each of the programs listed in subsection (j) of this
section; and on the effectiveness of the activities assisted under grants under subsection (a) of
this section in controlling such diseases and conditions.

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(i) Technical assistance
The Secretary may provide technical assistance to States, State health authorities, and other
public entities in connection with the operation of their preventive health service programs.
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for
which are established in paragraph (2), for grants under subsections (a) and (k)(1) of this
section for preventive health service programs to immunize without charge children,
adolescents, and adults against vaccine-preventable diseases, there are authorized to be
appropriated such sums as may be necessary for each of the fiscal years 1998 through
2005. Not more than 10 percent of the total amount appropriated under the preceding
sentence for any fiscal year shall be available for grants under subsection (k)(1) of this
section for such fiscal year.
(2) For grants under subsection (a) of this section for preventive health service programs
for the provision without charge of immunizations with vaccines approved for use, and
recommended for routine use, after October 1, 1997, there are authorized to be
appropriated such sums as may be necessary.

(k) Additional grants to States, political subdivisions, and other public and nonprofit private
entities
(1) The Secretary may make grants to States, political subdivisions of States, and other
public and nonprofit private entities for (A) research into the prevention and control of diseases that may be prevented
through vaccination;
(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of
such diseases; and
(D) education, training, and clinical skills improvement activities in the
prevention and control of such diseases for health professionals (including allied
health personnel).
(2) The Secretary may make grants to States, political subdivisions of States, and other
public and nonprofit private entities for (A) research into the prevention and control of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and
conditions;
(C) public information and education programs for the prevention and control of
such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the
prevention and control of such diseases and conditions for health professionals
(including allied health personnel).
(3) No grant may be made under this subsection unless an application therefore is
submitted to the Secretary in such form, at such time, and containing such information as
the Secretary may by regulation prescribe.

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(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection
in the same manner as such subsections apply to grants under subsection (a) of this
section.
Excerpted from: U.S. Code TITLE 42--THE PUBLIC HEALTH AND WELFARE; CHAPTER
6A--PUBLIC HEALTH SERVICE; SUBCHAPTER II--GENERAL POWERS AND DUTIES;
Part B--Federal-State Cooperation
Section 247d-4. Revitalizing the Centers for Disease Control and Prevention
(a) Facilities; capacities
(1) Findings
Congress finds that the Centers for Disease Control and Prevention has an essential role
in defending against and combating public health threats and requires secure and
modern facilities, and expanded and improved capabilities related to bioterrorism and
other public health emergencies, sufficient to enable such Centers to conduct this
important mission.
(2) Facilities
(A) In general
The Director of the Centers for Disease Control and Prevention may design,
construct, and equip new facilities, renovate existing facilities (including
laboratories, laboratory support buildings, scientific communication facilities,
transshipment complexes, secured and isolated parking structures, office
buildings, and other facilities and infrastructure), and upgrade security of such
facilities, in order to better conduct the capacities described in section 247d-1
of this title, and for supporting public health activities.
(B) Multiyear contracting authority
For any project of designing, constructing, equipping, or renovating any
facility under subparagraph (A), the Director of the Centers for Disease
Control and Prevention may enter into a single contract or related contracts
that collectively include the full scope of the project, and the solicitation and
contract shall contain the clause "availability of funds" found at section
52.232-18 of title 48, Code of Federal Regulations.
(3) Improving the capacities of the Centers for Disease Control and Prevention
The Secretary, taking into account evaluations under section 247d-2(a) of this title
shall expand, enhance, and improve the capabilities of the Centers for Disease Control
and Prevention relating to preparedness for and responding effectively to bioterrorism
and other public health emergencies. Activities that may be carried out under the
preceding sentence include (A) expanding or enhancing the training of personnel;
(B) improving communications facilities and networks, including delivery of
necessary information to rural areas;
(C) improving capabilities for public health surveillance and reporting
activities, taking into account the integrated system or systems of public
health alert communications and surveillance networks under subsection (b)
of this section; and

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(D) improving laboratory facilities related to bioterrorism and other public
health emergencies, including increasing the security of such facilities.
(b) National communications and surveillance networks
(1) In general
The Secretary, directly or through awards of grants, contracts, or cooperative
agreements, shall provide for the establishment of an integrated system or systems of
public health alert communications and surveillance networks between and among (A) Federal, State, and local public health officials;
(B) public and private health-related laboratories, hospitals, and other health
care facilities; and
(C) any other entities determined appropriate by the Secretary.
(2) Requirements
The Secretary shall ensure that networks under paragraph (1) allow for the timely
sharing and discussion, in a secure manner, of essential information concerning
bioterrorism or another public health emergency, or recommended methods for
responding to such an attack or emergency.
(3) Standards
Not later than one year after June 12, 2002, the Secretary, in cooperation with health
care providers and State and local public health officials, shall establish any additional
technical and reporting standards (including standards for interoperability) for networks
under paragraph (1).
(c) Authorization of appropriations
(1) Facilities; capacities
(A) Facilities
For the purpose of carrying out subsection (a)(2) of this section, there are
authorized to be appropriated $300,000,000 for each of the fiscal years 2002
and 2003, and such sums as may be necessary for each of the fiscal years 2004
through 2006.
(B) Mission; improving capacities
For the purposes of achieving the mission of the Centers for Disease Control
and Prevention described in subsection (a)(1) of this section, for carrying out
subsection (a)(3) of this section, for better conducting the capacities described
in section 247d-1 of this title, and for supporting public health activities, there
are authorized to be appropriated such sums as may be necessary for each of
the fiscal years 2002 through 2006.
(2) National communications and surveillance networks
For the purpose of carrying out subsection (b) of this section, there are authorized to be
appropriated such sums as may be necessary for each of the fiscal years 2002 through
2006.

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Pandemic and All-Hazards Preparedness Act
(Public Law 109-417)

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