Attachment C_42 USC 241

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Multisite Evaluation of the In Community Spirit Program - Prevention of HIV/AIDS for Native/American Indian and Alaska Native Women Living in Rural and Frontier Indian Country

Attachment C_42 USC 241

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42 USC 241 - Sec. 241. Research and investigations
generally

US Code - Title 42: The Public Health and Welfare
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Text
ÊÊ(a) Authority of Secretary The Secretary shall conduct in the Service, and encourage,
cooperate with, and render assistance to other appropriate public authorities,
scientific institutions, and scientists in the conduct of, and promote the coordination
of, research, investigations, experiments, demonstrations, and studies relating to the
causes, diagnosis, treatment, control, and prevention of physical and mental diseases
and impairments of man, including water purification, sewage treatment, and pollution
of lakes and streams.
In carrying out the foregoing the Secretary is authorized to - (1) collect and make
available through publications and other appropriate means, information as to, and
the practical application of, such research and other activities; (2) make available
research facilities of the Service to appropriate public authorities, and to health
officials and scientists engaged in special study; (3) make grants-in-aid to universities,
hospitals, laboratories, and other public or private institutions, and to individuals for
such research projects as are recommended by the advisory council to the entity of
the Department supporting such projects and make, upon recommendation of the
advisory council to the appropriate entity of the Department, grants-in-aid to public or
nonprofit universities, hospitals, laboratories, and other institutions for the general
support of their research; (4) secure from time to time and for such periods as he
deems advisable, the assistance and advice of experts, scholars, and consultants from
the United States or abroad; (5) for purposes of study, admit and treat at institutions,
hospitals, and stations of the Service, persons not otherwise eligible for such
treatment; (6) make available, to health officials, scientists, and appropriate public
and other nonprofit institutions and organizations, technical advice and assistance on
the application of statistical methods to experiments, studies, and surveys in health
and medical fields; (7) enter into contracts, including contracts for research in
accordance with and subject to the provisions of law applicable to contracts entered
into by the military departments under sections 2353 and 2354 of title 10, except that

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determination, approval, and certification required thereby shall be by the Secretary
of Health and Human Services; and (8) adopt, upon recommendations of the advisory
councils to the appropriate entities of the Department or, with respect to mental
health, the National Advisory Mental Health Council, such additional means as the
Secretary considers necessary or appropriate to carry out the purposes of this section.
The Secretary may make available to individuals and entities, for biomedical and
behavioral research, substances and living organisms.
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)

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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 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.
Amendments
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, Sec. 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

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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, Sec.
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, Sec. 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, Sec. 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

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former concluding provisions of section 242a(a) of this title.
See 1988 Amendment note above.
Subsecs. (e), (f). Pub. L. 93-348, Sec. 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, Sec. 104(a)(1)(C), redesignated subsec. (h) as (g). Former
subsec. (g) redesignated (f). Subsecs. (h), (i). Pub. L. 93-348, Sec. 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, Sec. 4(e), and June 24, 1948, Sec. 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, Sec. 4(f), and June 24, 1948, Sec. 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.

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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, Sec.
1000(a)(6) [title VII, Sec. 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, Sec. 101(d) [title V, Sec. 520], Apr. 26,
1996, 110 Stat. 1321-211, 1321-250; renumbered title I, Pub. L. 104-140, Sec. 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

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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, Sec. 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. 100607 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

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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, Sec. 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, Sec. 7, Jan. 4, 1983,
96 Stat. 2059, 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; "(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; and "(4) prepare and transmit to the Congress within
one year after the date of enactment of this Act [Jan. 4, 1983] a report with respect to
the activities conducted in carrying out paragraphs (1), (2), and (3). "(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

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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. "(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.
The Secretary of Health and Human Services shall update these tables and formulas
every four years, or whenever he deems it necessary to insure that they continue to
represent the best available scientific data and expertise." TERMINATION OF ADVISORY
COMMITTEES Pub. L. 93-641, Sec. 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.
Section Referred To In Other Sections
This section is referred to in sections 242, 254c, 254c-8, 254c-14, 263, 282, 284, 284f,
7610 of this title.

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