Attachment A - PHS Act Sec 301

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42 USC 241 - Sec. 241. Research and investigations
generally
42 USC - US Code - Title 42: The Public Health and Welfare (January 2003)
Id. vLex: VLEX-19253275
http://vlex.com/vid/19253275

Text

(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

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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

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2354 of title 10, except that determination,
approval, and certification required thereby
shall be by the Secretary of Health and Human
Services;
and
(8)
adopt,
upon
recommendations of the advisory councils to
the appropriate entities of the Department or,
with respect to mental health, the National
Advisory Mental Health Council, such
additional means as the Secretary considers
necessary or appropriate to carry out the
purposes of this section.
The Secretary may make available to
individuals and entities, for biomedical and
behavioral research, substances and living
organisms.
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

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research and may support such research by
others through grants and contracts. (B) The
Secretary shall conduct a comprehensive
review of Federal programs of research on the
biological effects of ionizing radiation. (3) The
Secretary shall conduct and may support
through grants and contracts research and
studies on human nutrition, with particular
emphasis on the role of nutrition in the
prevention and treatment of disease and on
the maintenance and promotion of health, and
programs for the dissemination of information
respecting human nutrition to health
professionals and the public.
In carrying out activities under this paragraph,
the Secretary shall provide for the coordination
of such of these activities as are performed by
the different divisions within the Department of
Health and Human Services and shall consult
with entities of the Federal Government,
outside of the Department of Health and
Human Services, engaged in comparable
activities.
The Secretary, upon request of such an entity
and under appropriate arrangements for the
payment of expenses, may conduct and
support such activities for such entity. (4) The
Secretary shall publish a biennial report which
contains - (A) a list of all substances (i) which
either are known to be carcinogens or may
reasonably be anticipated to be carcinogens
and (ii) to which a significant number of
persons residing in the United States are
exposed; (B) information concerning the nature
of such exposure and the estimated number of
persons exposed to such substances; (C) a
statement identifying (i) each substance
contained in the list under subparagraph (A) for
which no effluent, ambient, or exposure
standard has been established by a Federal
agency, and (ii) for each effluent, ambient, or
exposure standard established by a Federal
agency with respect to a substance contained

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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

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such individuals may not be compelled in any
Federal, State, or local civil, criminal,
administrative, legislative, or other proceedings
to identify such individuals.
MISC
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 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,

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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

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"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 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

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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. 92218 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.

Advisory
Dental
respectively.

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

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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Research

Council,

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.

CHANGE
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.
MISC
Effective Date Of 1978 Amendment
Sections 261 and 262 of Pub. L. 95-622
provided that the amendments made by those

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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.

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.

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.

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.

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

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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

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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. 102531, 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. 100-607 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

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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. 100607 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. 99117, 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.

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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
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

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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.

SECREF
Section Referred To In Other Sections
This section is referred to in sections 242,
254c, 254c-8, 254c-14, 263, 282, 284, 284f,

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7610 of this title.

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