Public Health Law

ATTACHMENT B: PUBLIC HEALTH SERVICE ACT

(42 USC 241) Section 301

United States Code

TITLE 42 – THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A – PUBLIC HEALTH SERVICE

SUBCHAPTER II – GENERAL POWERS AND DUTIES

Part A – Research and Investigations

U.S. Code as of: 01/26/1998

Sec. 241. Research and investigations generally

(a) Authority of Secretary

The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water

purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to -

(1) collect and make available through publications and other

appropriate means, information as to, and the practical

application of, such research and other activities;

(2) make available research facilities of the Service to

appropriate public authorities, and to health officials and

scientists engaged in special study;

(3) make grants-in-aid to universities, hospitals,

laboratories, and other public or private institutions, and to

individuals for such research projects as are recommended by the

advisory council to the entity of the Department supporting such

projects and make, upon recommendation of the advisory council to

the appropriate entity of the Department, grants-in-aid to public

or nonprofit universities, hospitals, laboratories, and other

institutions for the general support of their research;

(4) secure from time to time and for such periods as he deems

advisable, the assistance and advice of experts, scholars, and

consultants from the United States or abroad;

(5) for purposes of study, admit and treat at institutions,

hospitals, and stations of the Service, persons not otherwise

eligible for such treatment;

(6) make available, to health officials, scientists, and

appropriate public and other nonprofit institutions and

organizations, technical advice and assistance on the application

of statistical methods to experiments, studies, and surveys in

health and medical fields;

(7) enter into contracts, including contracts for research in

accordance with and subject to the provisions of law applicable

to contracts entered into by the military departments under

sections 2353 and 2354 of title 10, except that determination,

approval, and certification required thereby shall be by the

Secretary of Health and Human Services; and

(8) adopt, upon recommendations of the advisory councils to the

appropriate entities of the Department or, with respect to mental

health, the National Advisory Mental Health Council, such

additional means as the Secretary considers necessary or

appropriate to carry out the purposes of this section.

The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.

(b) Testing for carcinogenicity, teratogenicity, mutagenicity, and

other harmful biological effects; consultation

(1) The Secretary shall conduct and may support through grants

and contracts studies and testing of substances for

carcinogenicity, teratogenicity, mutagenicity, and other harmful

biological effects. In carrying out this paragraph, the Secretary

shall consult with entities of the Federal Government, outside of

the Department of Health and Human Services, engaged in comparable

activities. The Secretary, upon request of such an entity and

under appropriate arrangements for the payment of expenses, may

conduct for such entity studies and testing of substances for

carcinogenicity, teratogenicity, mutagenicity, and other harmful

biological effects.

(2)(A) The Secretary shall establish a comprehensive program of

research into the biological effects of low-level ionizing

radiation under which program the Secretary shall conduct such

research and may support such research by others through grants and

contracts.

(B) The Secretary shall conduct a comprehensive review of Federal

programs of research on the biological effects of ionizing

radiation.

(3) The Secretary shall conduct and may support through grants

and contracts research and studies on human nutrition, with

particular emphasis on the role of nutrition in the prevention and

treatment of disease and on the maintenance and promotion of

health, and programs for the dissemination of information

respecting human nutrition to health professionals and the public.

In carrying out activities under this paragraph, the Secretary

shall provide for the coordination of such of these activities as

are performed by the different divisions within the Department of

Health and Human Services and shall consult with entities of the

Federal Government, outside of the Department of Health and Human

Services, engaged in comparable activities. The Secretary, upon

request of such an entity and under appropriate arrangements for

the payment of expenses, may conduct and support such activities

for such entity.

(4) The Secretary shall publish a biennial report which contains

-

(A) a list of all substances (i) which either are known to be

carcinogens or may reasonably be anticipated to be carcinogens

and (ii) to which a significant number of persons residing in the

United States are exposed;

(B) information concerning the nature of such exposure and the

estimated number of persons exposed to such substances;

(C) a statement identifying (i) each substance contained in the

list under subparagraph (A) for which no effluent, ambient, or

exposure standard has been established by a Federal agency, and

(ii) for each effluent, ambient, or exposure standard established

by a Federal agency with respect to a substance contained in the

list under subparagraph (A), the extent to which, on the basis of

available medical, scientific, or other data, such standard, and

the implementation of such standard by the agency, decreases the

risk to public health from exposure to the substance; and

(D) a description of (i) each request received during the year

involved -

(I) from a Federal agency outside the Department of Health

and Human Services for the Secretary, or

(II) from an entity within the Department of Health and Human

Services to any other entity within the Department,

to conduct research into, or testing for, the carcinogenicity of

substances or to 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.

Source

(July 1, 1944, ch. 373, title III, Sec. 301, 58 Stat. 691; July 3,

1946, ch. 538, Sec. 7(a), (b), 60 Stat. 423; June 16, 1948, ch.

481, Sec. 4(e), (f), 62 Stat. 467; June 24, 1948, ch. 621, Sec.

4(e), (f), 62 Stat. 601; June 25, 1948, ch. 654, Sec. 1, 62 Stat.

1017; July 3, 1956, ch. 510, Sec. 4, 70 Stat. 490; Sept. 15, 1960,

Pub. L. 86-798, 74 Stat. 1053; Oct. 17, 1962, Pub. L. 87-838, Sec.

2, 76 Stat. 1073; Aug. 9, 1965, Pub. L. 89-115, Sec. 3, 79 Stat.

448; Dec. 5, 1967, Pub. L. 90-174, Sec. 9, 81 Stat. 540; Oct. 27,

1970, Pub. L. 91-513, title I, Sec. 3(a), 84 Stat. 1241; Oct. 30,

1970, Pub. L. 91-515, title II, Sec. 292, 84 Stat. 1308; Dec. 23,

1971, Pub. L. 92-218, Sec. 6(a)(2), 85 Stat. 785; Sept. 19, 1972,

Pub. L. 92-423, Sec. 7(b), 86 Stat. 687; May 14, 1974, Pub. L.

93-282, title I, Sec. 122(b), 88 Stat. 132; July 12, 1974, Pub. L.

93-348, title I, Sec. 104(a)(1), 88 Stat. 346; July 23, 1974, Pub.

L. 93-352, title I, Sec. 111, 88 Stat. 360; Apr. 22, 1976, Pub. L.

94-278, title I, Sec. 111, 90 Stat. 405; Nov. 9, 1978, Pub. L.

95-622, title II, Sec. 261, 262, 92 Stat. 3434; Oct. 17, 1979, Pub.

L. 96-88, title V, Sec. 509(b), 93 Stat. 695; Nov. 20, 1985, Pub.

L. 99-158, Sec. 3(a)(5), 99 Stat. 879; Oct. 27, 1986, Pub. L.

99-570, title IV, Sec. 4021(b)(2), 100 Stat. 3207-124; Nov. 14,

1986, Pub. L. 99-660, title I, Sec. 104, 100 Stat. 3751; Nov. 4,

1988, Pub. L. 100-607, title I, Sec. 163(1), (2), 102 Stat. 3062;

June 10, 1993, Pub. L. 103-43, title XX, Sec. 2009, 107 Stat. 213.)