Public Health Services Law

Attachment 1:

U.S. Public Health Service Act (42 U.S.C.241)

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC

HEALTH SERVICE

PART A—RESEARCH AND INVESTIGATION

IN GENERAL

SEC. 301. ø241¿ (a) 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

title 10, United States Code, sections 2353 and 2354, except

that determination, approval, and certification required thereby

shall be by the Secretary of Health, Education, and Welfare;

and

Sec. 301 PUBLIC HEALTH SERVICE ACT 68

(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)(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, Education, and Welfare, 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,

Education, and Welfare and shall consult with entities of the Federal

Government, outside of the Department of Health, Education,

and Welfare, 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,

69 PUBLIC HEALTH SERVICE ACT Sec. 302

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, Education, and Welfare for the Secretary, or

(II) from an entity within the Department of Health,

Education, and Welfare 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) 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) 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.