42 Usc 241

Protection of Human Subjects and Institutional Review Boards

42 USC 241

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§ 241

TITLE 42—THE PUBLIC HEALTH AND WELFARE
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;
(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

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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. 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 subpara-

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graph (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
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.
(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.
(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,

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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.)
AMENDMENTS
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.
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’’.

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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
‘‘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.

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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.
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.
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,

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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
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
Section 1910 of Pub. L. 103–43 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
Section 161 of Pub. L. 100–607, 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
Section 162 of Pub. L. 100–607 directed Secretary of
Health and Human Services, after consultation with

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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.
RESEARCH WITH RESPECT TO HEALTH RESOURCES AND
SERVICES ADMINISTRATION
Section 632 of Pub. L. 100–607 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 [this section] 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 [this section], 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,

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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.
‘‘(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.

Page 122

(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.
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.

Page 123

TITLE 42—THE PUBLIC HEALTH AND WELFARE

§ 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.
(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,

§ 242b

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.
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)
containing such recommendations for legislative and
administrative action as he may deem appropriate, was
repealed by Pub. L. 98–24, § 2(d), Apr. 26, 1983, 97 Stat.
182.

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

§ 242b. General authority respecting research,
evaluations, and demonstrations in health
statistics, health services, and health care
technology
(a) Scope of activities
The Secretary may, through the Agency for
Healthcare Research and Quality or the National Center for Health Statistics, or using
Ruth L. Kirschstein National Research Service
Awards or other appropriate authorities, undertake and support training programs to provide
for an expanded and continuing supply of individuals qualified to perform the research, eval-


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