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

Appendix A: Authorizing Legislation
This data collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241) as
follows:
42 U.S. Code § 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.
(e) Preterm labor and delivery and infant mortality
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
expand, intensify, and coordinate the activities of the Centers for Disease Control and Prevention with
respect to preterm labor and delivery and infant mortality.