Section 301 of the Public Health Service Act

Section 301 of the Public Health Service Act (42 U.S.C.241)

TITLE 42 > CHAPTER 6A > SUBCHAPTER II > Part A > § 241

§ 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.