Authorizing Legislation

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(B) Stipend
The Surgeon General, based on the recommendations of the National Health Care
Workforce Commission, shall establish and
update Federal stipend rates for payment to
students under this part.
(3) Reductions in the period of obligated service
The period of obligated service under paragraph (1)(A)(ii)(V) shall be reduced—
(A) in the case of a student who elects to
participate in a high-needs speciality residency (as determined by the National Health
Care Workforce Commission), by 3 months
for each year of such participation (not to
exceed a total of 12 months); and
(B) in the case of a student who, upon completion of their residency, elects to practice
in a Federal medical facility (as defined in
section 781(e)) 1 that is located in a health
professional shortage area (as defined in section 254e of this title), by 3 months for year 2
of full-time practice in such a facility (not
to exceed a total of 12 months).
(c) Second 2 years of service
During the third and fourth years in which a
medical, dental, physician assistant, pharmacy,
behavioral and mental health, public health, or
nursing student is enrolled in the Track, training should be designed to prioritize clinical rotations in Federal medical facilities in health professional shortage areas, and emphasize a balance of hospital and community-based experiences, and training within interdisciplinary
teams.
(d) Dentist, physician assistant, pharmacist, behavioral and mental health professional,
public health professional, and nurse training
The Surgeon General shall establish provisions applicable with respect to dental, physician assistant, pharmacy, behavioral and mental
health, public health, and nursing students that
are comparable to those for medical students
under this section, including service obligations,
tuition support, and stipend support. The Surgeon General shall give priority to health professions training institutions that train medical, dental, physician assistant, pharmacy, behavioral and mental health, public health, and
nursing students for some significant period of
time together, but at a minimum have a discrete and shared core curriculum.
(e) Elite Federal disaster teams
The Surgeon General, in consultation with the
Secretary, the Director of the Centers for Disease Control and Prevention, and other appropriate military and Federal government agencies, shall develop criteria for the appointment
of highly qualified Track faculty, medical, dental, physician assistant, pharmacy, behavioral
and mental health, public health, and nursing
students, and graduates to elite Federal disaster
preparedness teams to train and to respond to
public health emergencies, natural disasters,
bioterrorism events, and other emergencies.
1 So
2 So

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

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(f) Student dropped from Track in affiliate
school
A medical, dental, physician assistant, pharmacy, behavioral and mental health, public
health, or nursing student who, under regulations prescribed by the Surgeon General, is
dropped from the Track in an affiliated school
for deficiency in conduct or studies, or for other
reasons, shall be liable to the United States for
all tuition and stipend support provided to the
student.
(July 1, 1944, ch. 373, title II, § 273, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
639.)
§ 239l–3. Funding
Beginning with fiscal year 2010, the Secretary
shall transfer from the Public Health and Social
Services Emergency Fund such sums as may be
necessary to carry out this part.
(July 1, 1944, ch. 373, title II, § 274, as added Pub.
L. 111–148, title V, § 5315, Mar. 23, 2010, 124 Stat.
642.)
TRANSFER OF APPROPRIATED FUNDS
Pub. L. 112–10, div. B, title VIII, § 1828, Apr. 15, 2011,
125 Stat. 162, provided that: ‘‘Hereafter, no funds appropriated by this division or by any previous or subsequent Act shall be available for transfer under section
274 [42 U.S.C. 239l–3] of the PHS Act [Public Health
Service Act].’’

SUBCHAPTER II—GENERAL POWERS AND
DUTIES
PART A—RESEARCH AND INVESTIGATIONS
§ 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, grantsin-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for
the general support of their research;

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(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.
(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

Page 122

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 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
(1)(A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which
identifiable, sensitive information is collected
(including research on mental health and research on the use and effect of alcohol and other
psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—
(i) shall issue to such person a certificate of
confidentiality to protect the privacy of individuals who are the subjects of such research

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if the research is funded wholly or in part by
the Federal Government; and
(ii) may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not
so funded.
(B) Except as provided in subparagraph (C),
any person to whom a certificate is issued under
subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not
disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive
information about such an individual and that
was created or compiled for purposes of the research.
(C) The disclosure prohibition in subparagraph
(B) shall not apply to disclosure or use that is—
(i) required by Federal, State, or local laws,
excluding instances described in subparagraph
(D);
(ii) necessary for the medical treatment of
the individual to whom the information, document, or biospecimen pertains and made with
the consent of such individual;
(iii) made with the consent of the individual
to whom the information, document, or biospecimen pertains; or
(iv) made for the purposes of other scientific
research that is in compliance with applicable
Federal regulations governing the protection
of human subjects in research.
(D) Any person to whom a certificate is issued
under subparagraph (A) to protect the privacy of
an individual described in such subparagraph
shall not, in any Federal, State, or local civil,
criminal, administrative, legislative, or other
proceeding, disclose or provide the name of such
individual or any such information, document,
or biospecimen that contains identifiable, sensitive information about the individual and that
was created or compiled for purposes of the research, except in the circumstance described in
subparagraph (C)(iii).
(E) Identifiable, sensitive information protected under subparagraph (A), and all copies
thereof, shall be immune from the legal process,
and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in
any action, suit, or other judicial, legislative, or
administrative proceeding.
(F) Identifiable, sensitive information collected by a person to whom a certificate has
been issued under subparagraph (A), and all copies thereof, shall be subject to the protections
afforded by this section for perpetuity.
(G) The Secretary shall take steps to minimize
the burden to researchers, streamline the process, and reduce the time it takes to comply with
the requirements of this subsection.
(2) The Secretary shall coordinate with the
heads of other applicable Federal agencies to ensure that such departments have policies in
place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1)
and other requirements of this subsection.
(3) Nothing in this subsection shall be construed to limit the access of an individual who

§ 241

is a subject of research to information about
himself or herself collected during such individual’s participation in the research.
(4) For purposes of this subsection, the term
‘‘identifiable, sensitive information’’ means information that is about an individual and that is
gathered or used during the course of research
described in paragraph (1)(A) and—
(A) through which an individual is identified; or
(B) for which there is at least a very small
risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources
could be used to deduce the identity of an individual.
(e) Preterm labor and delivery and infant mortality
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention,
shall expand, intensify, and coordinate the activities of the Centers for Disease Control and
Prevention with respect to preterm labor and
delivery and infant mortality.
(f) Exemption of certain biomedical information
from disclosure
(1) The Secretary may exempt from disclosure
under section 552(b)(3) of title 5 biomedical information that is about an individual and that is
gathered or used during the course of biomedical
research if—
(A) an individual is identified; or
(B) there is at least a very small risk, as determined by current scientific practices or
statistical methods, that some combination of
the information, the request, and other available data sources could be used to deduce the
identity of an individual.
(2)(A) Each determination of the Secretary
under paragraph (1) to exempt information from
disclosure shall be made in writing and accompanied by a statement of the basis for the determination.
(B) Each such determination and statement of
basis shall be available to the public, upon request, through the Office of the Chief FOIA Officer of the Department of Health and Human
Services.
(3) Nothing in this subsection shall be construed to limit a research participant’s access to
information about such participant collected
during the participant’s participation in the research.
(g) Inapplicability of Federal information policy
Subchapter I of chapter 35 of title 44 shall not
apply to the voluntary collection of information
during the conduct of research by the National
Institutes of Health.
(h) Availability of substances and living organisms for biomedical and behavioral research
(1) The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms.
Such substances and organisms shall be made
available under such terms and conditions (including payment for them) as the Secretary determines appropriate.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(2) Where research substances and living organisms are made available under paragraph (1)
through contractors, the Secretary may direct
such contractors to collect payments on behalf
of the Secretary for the costs incurred to make
available such substances and organisms and to
forward amounts so collected to the Secretary,
in the time and manner specified by the Secretary.
(3) Amounts collected under paragraph (2)
shall be credited to the appropriations accounts
that incurred the costs to make available the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts.
(July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691;
July 3, 1946, ch. 538, § 7(a), (b), 60 Stat. 423; June
16, 1948, ch. 481, § 4(e), (f), 62 Stat. 467; June 24,
1948, ch. 621, § 4(e), (f), 62 Stat. 601; June 25, 1948,
ch. 654, § 1, 62 Stat. 1017; July 3, 1956, ch. 510, § 4,
70 Stat. 490; Pub. L. 86–798, Sept. 15, 1960, 74 Stat.
1053; Pub. L. 87–838, § 2, Oct. 17, 1962, 76 Stat. 1073;
Pub. L. 89–115, § 3, Aug. 9, 1965, 79 Stat. 448; Pub.
L. 90–174, § 9, Dec. 5, 1967, 81 Stat. 540; Pub. L.
91–513, title I, § 3(a), Oct. 27, 1970, 84 Stat. 1241;
Pub. L. 91–515, title II, § 292, Oct. 30, 1970, 84 Stat.
1308; Pub. L. 92–218, § 6(a)(2), Dec. 23, 1971, 85
Stat. 785; Pub. L. 92–423, § 7(b), Sept. 19, 1972, 86
Stat. 687; Pub. L. 93–282, title I, § 122(b), May 14,
1974, 88 Stat. 132; Pub. L. 93–348, title I,
§ 104(a)(1), July 12, 1974, 88 Stat. 346; Pub. L.
93–352, title I, § 111, July 23, 1974, 88 Stat. 360;
Pub. L. 94–278, title I, § 111, Apr. 22, 1976, 90 Stat.
405; Pub. L. 95–622, title II, §§ 261, 262, Nov. 9, 1978,
92 Stat. 3434; Pub. L. 96–88, title V, § 509(b), Oct.
17, 1979, 93 Stat. 695; Pub. L. 99–158, § 3(a)(5), Nov.
20, 1985, 99 Stat. 879; Pub. L. 99–570, title IV,
§ 4021(b)(2), Oct. 27, 1986, 100 Stat. 3207–124; Pub.
L. 99–660, title I, § 104, Nov. 14, 1986, 100 Stat.
3751; Pub. L. 100–607, title I, § 163(1), (2), Nov. 4,
1988, 102 Stat. 3062; Pub. L. 103–43, title XX,
§ 2009, June 10, 1993, 107 Stat. 213; Pub. L. 109–450,
§ 3(a), Dec. 22, 2006, 120 Stat. 3341; Pub. L. 114–255,
div. A, title II, §§ 2012(a), 2013, 2035, 2043, Dec. 13,
2016, 130 Stat. 1049, 1050, 1062, 1074.)
AMENDMENTS
2016—Subsec. (a). Pub. L. 114–255, § 2043(1), redesignated concluding provisions of subsec. (a) as par. (1) of
subsec. (h).
Subsec. (d). Pub. L. 114–255, § 2012(a), amended subsec.
(d) generally. Prior to amendment, text read as follows:
‘‘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.’’
Subsec. (f). Pub. L. 114–255, § 2013, added subsec. (f).
Subsec. (g). Pub. L. 114–255, § 2035, added subsec. (g).
Subsec. (h). Pub. L. 114–255, § 2043, redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h)
and added pars. (2) and (3).
2006—Subsec. (e). Pub. L. 109–450 added subsec. (e).
1993—Subsec. (b)(4). Pub. L. 103–43 substituted ‘‘a biennial report’’ for ‘‘an annual report’’ in introductory
provisions.

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

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

§ 241

CHANGE OF NAME
‘‘Secretary of Health and Human Services’’ substituted for ‘‘Secretary of Health, Education, and Welfare’’ in subsec. (a)(7), and ‘‘Department of Health and
Human Services’’ substituted for ‘‘Department of
Health, Education, and Welfare’’ in subsec. (b)(1), (3),
and (4)(D)(I), (II), pursuant to section 509(b) of Pub. L.
96–88 which is classified to section 3508(b) of Title 20,
Education.
EFFECTIVE DATE OF 1978 AMENDMENT
Sections 261 and 262 of Pub. L. 95–622 provided that
the amendments made by those sections are effective
Oct. 1, 1978.
EFFECTIVE DATE OF 1974 AMENDMENT
Section 104(b) of Pub. L. 93–348 provided that: ‘‘The
amendments made by subsection (a) [amending this
section and sections 242a, 282, 286a, 286b, 287a, 287b, 287d,
288a, 289c, 289c–1, 289g, 289k, and heading preceding section 289l of this title] shall not apply with respect to
commitments made before the date of the enactment of
this Act [July 12, 1974] by the Secretary of Health, Education, and Welfare for research training under the provisions of the Public Health Service Act amended or repealed by subsection (a).’’
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92–423 effective 60 days after
Sept. 19, 1972, or on such prior date after Sept. 19, 1972,
as the President shall prescribe and publish in the Federal Register, see section 9 of Pub. L. 92–423, set out as
a note under section 218 of this title.
EFFECTIVE DATE OF 1971 AMENDMENT
Amendment by Pub. L. 92–218 effective 60 days after
Dec. 23, 1971, or on such prior date after Dec. 23, 1971,
as the President shall prescribe and publish in the Federal Register, see section 7 of Pub. L. 92–218, set out as
a note under section 218 of this title.
APPLICABILITY OF 2016 AMENDMENT
Pub. L. 114–255, div. A, title II, § 2012(b), Dec. 13, 2016,
130 Stat. 1050, provided that: ‘‘Beginning 180 days after
the date of enactment of this Act [Dec. 13, 2016], all persons engaged in research and authorized by the Secretary of Health and Human Services to protect information under section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) prior to the date of enactment
of this Act shall be subject to the requirements of such
section (as amended by this Act).’’
COORDINATION OF DATA SURVEYS AND REPORTS
Pub. L. 106–113, div. B, § 1000(a)(6) [title VII, § 703(e)],
Nov. 29, 1999, 113 Stat. 1536, 1501A–402, provided that:
‘‘The Secretary of Health and Human Services, through
the Assistant Secretary for Planning and Evaluation,
shall establish a clearinghouse for the consolidation
and coordination of all Federal databases and reports
regarding children’s health.’’
FEMALE GENITAL MUTILATION
Pub. L. 104–134, title I, § 101(d) [title V, § 520], Apr. 26,
1996, 110 Stat. 1321–211, 1321–250; renumbered title I,
Pub. L. 104–140, § 1(a), May 2, 1996, 110 Stat. 1327, provided that:
‘‘(a) Congress finds that—
‘‘(1) the practice of female genital mutilation is
carried out by members of certain cultural and religious groups within the United States; and
‘‘(2) the practice of female genital mutilation often
results in the occurrence of physical and psychological health effects that harm the women involved.
‘‘(b) The Secretary of Health and Human Services
shall do the following:
‘‘(1) Compile data on the number of females living
in the United States who have been subjected to female genital mutilation (whether in the United

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

States or in their countries of origin), including a
specification of the number of girls under the age of
18 who have been subjected to such mutilation.
‘‘(2) Identify communities in the United States that
practice female genital mutilation, and design and
carry out outreach activities to educate individuals
in the communities on the physical and psychological
health effects of such practice. Such outreach activities shall be designed and implemented in collaboration with representatives of the ethnic groups practicing such mutilation and with representatives of organizations with expertise in preventing such practice.
‘‘(3) Develop recommendations for the education of
students of schools of medicine and osteopathic medicine regarding female genital mutilation and complications arising from such mutilation. Such recommendations shall be disseminated to such schools.
‘‘(c) For purposes of this section the term ‘female
genital mutilation’ means the removal or infibulation
(or both) of the whole or part of the clitoris, the labia
minor, or the labia major.
‘‘(d) The Secretary of Health and Human Services
shall commence carrying out this section not later
than 90 days after the date of enactment of this Act
[Apr. 26, 1996].’’
SENTINEL DISEASE CONCEPT STUDY
Pub. L. 103–43, title XIX, § 1910, June 10, 1993, 107 Stat.
205, directed Secretary of Health and Human Services,
in cooperation with Agency for Toxic Substances and
Disease Registry and Centers for Disease Control and
Prevention, to design and implement a pilot sentinel
disease surveillance system for identifying relationship
between occupation of household members and incidence of subsequent conditions or diseases in other
members of household, and required Director of the National Institutes of Health to prepare and submit to
Congress, not later than 4 years after June 10, 1993, a
report concerning this project.
STUDY OF THYROID MORBIDITY FOR HANFORD,
WASHINGTON
Pub. L. 100–607, title I, § 161, Nov. 4, 1988, 102 Stat.
3059, as amended by Pub. L. 102–531, title III, § 312(e)(1),
Oct. 27, 1992, 106 Stat. 3506, directed Secretary of Health
and Human Services, acting through Director of Centers for Disease Control and Prevention, to conduct a
study of thyroid morbidity of the population, including
Indian tribes and tribal organizations, in vicinity of
Hanford, in State of Washington, authorized Director
to contract out portions of study, and required Director, not later than 42 months after Nov. 4, 1988, to
transmit a report, including such study, to Congress,
chief executive officers of States of Oregon and Washington, and governing officials of Indian tribes in vicinity of Hanford, Washington.
NATIONAL COMMISSION ON SLEEP DISORDERS RESEARCH
Pub. L. 100–607,title I, § 162, Nov. 4, 1988, 102 Stat. 3060,
directed Secretary of Health and Human Services, after
consultation with Director of National Institutes of
Health, to establish a National Commission on Sleep
Disorders Research to conduct a comprehensive study
of present state of knowledge of incidence, prevalence,
morbidity, and mortality resulting from sleep disorders, and of social and economic impact of such disorders, evaluate public and private facilities and resources (including trained personnel and research activities) available for diagnosis, prevention, and treatment of, and research into, such disorders, and identify
programs (including biological, physiological, behavioral, environmental, and social programs) by which
improvement in management and research into sleep
disorders could be accomplished and, not later than 18
months after initial meeting of Commission, to submit
to appropriate Committees of Congress a final report,
and provided for termination of the Commission 30 days
after submission of final report.

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RESEARCH WITH RESPECT TO HEALTH RESOURCES AND
SERVICES ADMINISTRATION
Pub. L. 100–607, title VI, § 632, Nov. 4, 1988, 102 Stat.
3147, provided that with respect to any program of research pursuant to this chapter, any such program carried out in fiscal year 1987 by an agency other than
Health Resources and Services Administration (or appropriate to be carried out by such an agency) could
not, for each of fiscal years 1989 through 1991, be carried
out by such Administration.
CONTINUING CARE FOR PSYCHIATRIC PATIENTS IN
FORMER CLINICAL RESEARCH CENTER AT NATIONAL
INSTITUTE ON DRUG ABUSE
Pub. L. 99–117, § 10, Oct. 7, 1985, 99 Stat. 494, provided
that: ‘‘In any fiscal year beginning after September 30,
1981, from funds appropriated for carrying out section
301 of the Public Health Service Act [42 U.S.C. 241] with
respect to mental health, the Secretary of Health and
Human Services may provide, by contract or otherwise,
for the continuing care of psychiatric patients who
were under active and continuous treatment at the National Institute on Drug Abuse Clinical Research Center on the date such Clinical Research Center ceased
operations.’’
ANALYSIS OF THYROID CANCER; CREATION AND
PUBLICATION OF RADIOEPIDEMIOLOGICAL TABLES
Pub. L. 97–414, § 7, Jan. 4, 1983, 96 Stat. 2059, as amended by Pub. L. 109–482, title I, § 104(b)(3)(A), Jan. 15, 2007,
120 Stat. 3694, provided that:
‘‘(a) In carrying out section 301 of the Public Health
Service Act [42 U.S.C. 241], the Secretary of Health and
Human Services shall—
‘‘(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
‘‘(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods
to estimate the thyroid doses of Iodine 131 that are
received by individuals from nuclear bomb fallout;
and
‘‘(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric
nuclear bomb tests.
‘‘(b)(1) Within one year after the date of enactment of
this Act [Jan. 4, 1983], the Secretary of Health and
Human Services shall devise and publish radioepidemiological tables that estimate the likelihood
that persons who have or have had any of the radiation
related cancers and who have received specific doses
prior to the onset of such disease developed cancer as
a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from
1 millirad to 1,000 rads in terms of sex, age at time of
exposure, time from exposure to the onset of the cancer
in question, and such other categories as the Secretary,
after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation
shall be calculated and displayed as a single percentage
figure.
‘‘(2) At the time the Secretary of Health and Human
Services publishes the tables pursuant to paragraph (1),
such Secretary shall also publish—
‘‘(A) for the tables of each radiation related cancer,
an evaluation which will assess the credibility, validity, and degree of certainty associated with such
tables; and
‘‘(B) a compilation of the formulas that yielded the
probabilities of causation listed in such tables. Such
formulas shall be published in such a manner and together with information necessary to determine the
probability of causation of any individual who has or
has had a radiation related cancer and has received
any given dose.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

‘‘(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from
the best available data that are most applicable to the
United States, and shall be devised in accordance with
the best available scientific procedures and expertise.’’
TERMINATION OF ADVISORY COMMITTEES
Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.
EXECUTIVE ORDER NO. 13435
Ex. Ord. No. 13435, June 20, 2007, 72 F.R. 34591, which
directed research with stem cells not derived from the
creation or destruction of a human embryo or fetus,
was revoked by Ex. Ord. No. 13505, § 5(b), Mar. 9, 2009, 74
F.R. 10668, set out below.
EX. ORD. NO. 13505. REMOVING BARRIERS TO RESPONSIBLE
SCIENTIFIC RESEARCH INVOLVING HUMAN STEM CELLS
Ex. Ord. No. 13505, Mar. 9, 2009, 74 F.R. 10667, provided:
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
SECTION 1. Policy. Research involving human embryonic stem cells and human non-embryonic stem cells
has the potential to lead to better understanding and
treatment of many disabling diseases and conditions.
Advances over the past decade in this promising scientific field have been encouraging, leading to broad
agreement in the scientific community that the research should be supported by Federal funds.
For the past 8 years, the authority of the Department
of Health and Human Services, including the National
Institutes of Health (NIH), to fund and conduct human
embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove
these limitations on scientific inquiry, to expand NIH
support for the exploration of human stem cell research, and in so doing to enhance the contribution of
America’s scientists to important new discoveries and
new therapies for the benefit of humankind.
SEC. 2. Research. The Secretary of Health and Human
Services (Secretary), through the Director of NIH, may
support and conduct responsible, scientifically worthy
human stem cell research, including human embryonic
stem cell research, to the extent permitted by law.
SEC. 3. Guidance. Within 120 days from the date of this
order, the Secretary, through the Director of NIH, shall
review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and
issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH,
shall review and update such guidance periodically, as
appropriate.
SEC. 4. General Provisions. (a) This order shall be implemented consistent with applicable law and subject
to the availability of appropriations.
(b) Nothing in this order shall be construed to impair
or otherwise affect:
(i) authority granted by law to an executive department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not, create
any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the
United States, its departments, agencies, or entities,
its officers, employees, or agents, or any other person.
SEC. 5. Revocations. (a) The Presidential statement of
August 9, 2001, limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.
(b) Executive Order 13435 of June 20, 2007, which supplements the August 9, 2001, statement on human embryonic stem cell research, is revoked.
BARACK OBAMA.

§ 241

GUIDELINES FOR HUMAN STEM CELL RESEARCH
Memorandum of President of the United States, July
30, 2009, 74 F.R. 38885, provided:
Memorandum for the Heads of Executive Departments and Agencies
As outlined in Executive Order 13505 of March 9, 2009,
my Administration is committed to supporting and
conducting ethically responsible, scientifically worthy
human stem cell research, including human embryonic
stem cell research, to the extent permitted by law. Pursuant to that order, the National Institutes of Health
(NIH) published final ‘‘National Institutes of Health
Guidelines for Human Stem Cell Research’’ (Guidelines), effective July 7, 2009. These Guidelines apply to
the expenditure of NIH funds for research using human
embryonic stem cells and certain uses of human induced pluripotent stem cells. The Guidelines are based
on the principles that responsible research with human
embryonic stem cells has the potential to improve our
understanding of human biology and aid in the discovery of new ways to prevent and treat illness, and that
individuals donating embryos for research purposes
should do so freely, with voluntary and informed consent. These Guidelines will ensure that NIH-funded research adheres to the highest ethical standards.
In order to ensure that all federally funded human
stem cell research is conducted according to these
same principles and to promote a uniform Federal policy across the executive branch, I hereby direct the
heads of executive departments and agencies that support and conduct stem cell research to adopt these
Guidelines, to the fullest extent practicable in light of
legal authorities and obligations. I also direct those departments and agencies to submit to the Director of
the Office of Management and Budget (OMB), within 90
days, proposed additions or revisions to any other guidance, policies, or procedures related to human stem cell
research, consistent with Executive Order 13505 and
this memorandum. The Director of the OMB shall, in
coordination with the Director of NIH, review these
proposals to ensure consistent implementation of Executive Order 13505 and this memorandum.
This memorandum is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other
person. Executive departments and agencies shall carry
out the provisions of this memorandum to the extent
permitted by law and consistent with their statutory
and regulatory authorities and their enforcement
mechanisms.
The Director of the OMB is hereby authorized and directed to publish this memorandum in the Federal Register.
BARACK OBAMA.
ENGAGING IN PUBLIC HEALTH RESEARCH ON THE CAUSES
AND PREVENTION OF GUN VIOLENCE
Memorandum of President of the United States, Jan.
16, 2013, 78 F.R. 4295, provided that:
Memorandum for the Secretary of Health and Human
Services
In addition to being a law enforcement challenge, gun
violence is also a serious public health issue that affects thousands of individuals, families, and communities across the Nation. Each year in the United
States there are approximately 30,000 firearm-related
deaths, and approximately 11,000 of those deaths result
from homicides. Addressing this critical issue requires
a comprehensive, multifaceted approach.
Recent research suggests that, in developing such an
approach, a broader public health perspective is imperative. Significant strides can be made by assessing the
causes of gun violence and the successful efforts in
place for preventing the misuse of firearms. Taking
these steps will improve our understanding of the gun
violence epidemic and will aid in the continued development of gun violence prevention strategies.

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

Therefore, by the authority vested in me as President
by the Constitution and the laws of the United States
of America, I hereby direct the following:
SECTION 1. Research. The Secretary of Health and
Human Services (Secretary), through the Director of
the Centers for Disease Control and Prevention and
other scientific agencies within the Department of
Health and Human Services, shall conduct or sponsor
research into the causes of gun violence and the ways
to prevent it. The Secretary shall begin by identifying
the most pressing research questions with the greatest
potential public health impact, and by assessing existing public health interventions being implemented
across the Nation to prevent gun violence.
SEC. 2. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability
of appropriations.
(c) This memorandum is not intended to, and does
not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party
against the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any other
person.
SEC. 3. Publication. You are hereby authorized and directed to publish this memorandum in the Federal Register.
BARACK OBAMA.

§ 242. Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation
with States
(a) In carrying out the purposes of section 241
of this title with respect to drugs the use or misuse of which might result in drug abuse or dependency, the studies and investigations authorized therein shall include the use and misuse of
narcotic drugs and other drugs. Such studies and
investigations shall further include the quantities of crude opium, coca leaves, and their
salts, derivatives, and preparations, and other
drugs subject to control under the Controlled
Substances Act [21 U.S.C. 801 et seq.] and Controlled Substances Import and Export Act [21
U.S.C. 951 et seq.], together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific requirements of
the United States. The results of studies and investigations of the quantities of narcotic drugs
or other drugs subject to control under such
Acts, together with reserves of such drugs, that
are necessary to supply the normal and emergency medicinal and scientific requirements of
the United States, shall be reported not later
than the first day of April of each year to the
Attorney General, to be used at his discretion in
determining manufacturing quotas or importation requirements under such Acts.
(b) The Surgeon General shall cooperate with
States for the purpose of aiding them to solve
their narcotic drug problems and shall give authorized representatives of the States the benefit of his experience in the care, treatment, and
rehabilitation of narcotic addicts to the end
that each State may be encouraged to provide
adequate facilities and methods for the care and
treatment of its narcotic addicts.

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(July 1, 1944, ch. 373, title III, § 302, 58 Stat. 692;
Pub. L. 91–513, title II, § 701(j), Oct. 27, 1970, 84
Stat. 1282.)
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec.
(a), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat.
1242, as amended, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of Title 21, Food
and Drugs. For complete classification of this Act to
the Code, see Short Title note set out under section 801
of Title 21 and Tables.
The Controlled Substances Import and Export Act,
referred to in subsec. (a), is title III of Pub. L. 91–513,
Oct. 27, 1970, 84 Stat. 1285, as amended, which is classified principally to subchapter II (§ 951 et seq.) of chapter 13 of Title 21. For complete classification of this
Act to the Code, see Short Title note set out under section 951 of Title 21 and Tables.
AMENDMENTS
1970—Subsec. (a). Pub. L. 91–513 inserted references to
drug dependency, drugs other than narcotic drugs, and
substances subject to control under the Controlled Substances Act and the Controlled Substances Import and
Export Act, substituted the first day of April of each
year for the first day of September of each year as the
date by which the study results must be submitted,
substituted the Attorney General for the Secretary of
the Treasury as the officer to whom the report is to be
submitted, and struck out references to the Narcotic
Drugs Import and Export Act.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91–513 effective on first day of
seventh calendar month that begins after Oct. 26, 1970,
see section 704 of Pub. L. 91–513, set out as an Effective
Date note under section 801 of Title 21, Food and Drugs.
SAVINGS PROVISION
Amendment by Pub. L. 91–513 not to affect or abate
any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment,
and all administrative proceedings pending before the
Bureau of Narcotics and Dangerous Drugs on Oct. 27,
1970, to be continued and brought to final determination in accord with laws and regulations in effect prior
to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out
as a note under section 321 of Title 21, Food and Drugs.
TRANSFER OF FUNCTIONS
Office of Surgeon General abolished by section 3 of
Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
80 Stat. 1610, and functions thereof transferred to Secretary of Health, Education, and Welfare by section 1 of
Reorg. Plan No. 3 of 1966, set out as a note under section 202 of this title. Secretary of Health, Education,
and Welfare redesignated Secretary of Health and
Human Services by section 509(b) of Pub. L. 96–88 which
is classified to section 3508(b) of Title 20, Education. Office of Surgeon General reestablished within the Office
of the Assistant Secretary for Health, see Notice of Department of Health and Human Services, Office of the
Assistant Secretary for Health, Mar. 30, 1987, 52 F.R.
11754.
MARIHUANA AND HEALTH REPORTING
Pub. L. 91–296, title V, June 30, 1970, 84 Stat. 352, as
amended by Pub. L. 95–461, § 3(a), Oct. 14, 1978, 92 Stat.
1268; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat.
695, known as the Marihuana and Health Reporting Act,
which required the Secretary of Health and Human
Services, after consultation with the Surgeon General
and other appropriate individuals, to transmit a report
to the Congress on or before January 31, 1971, and biennially thereafter (1) containing current information on
the health consequences of using marihuana, and (2)