Att 1_Authorizing Legislation

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Sec. 274

PUBLIC HEALTH SERVICE ACT

72

lations prescribed by the Surgeon General, is dropped from the
Track in an affiliated school for deficiency in conduct or studies, or
for other reasons, shall be liable to the United States for all tuition
and stipend support provided to the student.
SEC. 274. ø239l–3¿ FUNDING.

Beginning with fiscal year 2010, the Secretary shall transfer
from the Public Health and Social Services Emergency Fund such
sums as may be necessary to carry out this part.
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
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Sec. 301

that determination, approval, and certification required thereby shall be by the Secretary of Health, Education, and Welfare;
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.
(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,
or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard esJune 29, 2018

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Sec. 301

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tablished 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)(1)(A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information
is collected (including research on mental health and research on
the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—
(i) shall issue to such person a certificate of confidentiality
to protect the privacy of individuals who are the subjects of
such research if the research is funded wholly or in part by the
Federal Government; and
(ii) may, upon application by a person engaged in research,
issue to such person a certificate of confidentiality to protect
the privacy of such individuals if the research is not so funded.
(B) Except as provided in subparagraph (C), any person to
whom a certificate is issued under subparagraph (A) to protect the
privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for
purposes of the research.
(C) The disclosure prohibition in subparagraph (B) shall not
apply to disclosure or use that is—
(i) required by Federal, State, or local laws, excluding instances described in subparagraph (D);
(ii) necessary for the medical treatment of the individual
to whom the information, document, or biospecimen pertains
and made with the consent of such individual;
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(iii) made with the consent of the individual to whom the
information, document, or biospecimen pertains; or
(iv) made for the purposes of other scientific research that
is in compliance with applicable Federal regulations governing
the protection of human subjects in research.
(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such
subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii).
(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal
process, and shall not, without the consent of the individual to
whom the information pertains, be admissible as evidence or used
for any purpose in any action, suit, or other judicial, legislative, or
administrative proceeding.
(F) Identifiable, sensitive information collected by a person to
whom a certificate has been issued under subparagraph (A), and all
copies thereof, shall be subject to the protections afforded by this
section for perpetuity.
(G) The Secretary shall take steps to minimize the burden to
researchers, streamline the process, and reduce the time it takes
to comply with the requirements of this subsection.
(2) The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have
policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of
this subsection.
(3) Nothing in this subsection shall be construed to limit the
access of an individual who is a subject of research to information
about himself or herself collected during such individual’s participation in the research.
(4) For purposes of this subsection, the term ‘‘identifiable, sensitive information’’ means information that is about an individual
and that is gathered or used during the course of research described in paragraph (1)(A) and—
(A) through which an individual is identified; or
(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods,
that some combination of the information, a request for the information, and other available data sources could be used to
deduce the identity of an individual.
(e) 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.
(f)(1) The Secretary may exempt from disclosure under section
552(b)(3) of title 5, United States Code, biomedical information that
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Sec. 302

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is about an individual and that is gathered or used during the
course of biomedical research if—
(A) an individual is identified; or
(B) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that some
combination of the information, the request, and other available data sources could be used to deduce the identity of an individual.
(2)(A) Each determination of the Secretary under paragraph (1)
to exempt information from disclosure shall be made in writing and
accompanied by a statement of the basis for the determination.
(B) Each such determination and statement of basis shall be
available to the public, upon request, through the Office of the
Chief FOIA Officer of the Department of Health and Human Services.
(3) Nothing in this subsection shall be construed to limit a research participant’s access to information about such participant
collected during the participant’s participation in the research.
(g) Subchapter I of chapter 35 of title 44, United States Code,
shall not apply to the voluntary collection of information during the
conduct of research by the National Institutes of Health.
(h)(1) 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.
(2) Where research substances and living organisms are made
available under paragraph (1) through contractors, the Secretary
may direct such contractors to collect payments on behalf of the
Secretary for the costs incurred to make available such substances
and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary.
(3) Amounts collected under paragraph (2) shall be credited to
the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and
shall remain available until expended for carrying out activities
under such accounts.
NARCOTICS

SEC. 302. ø242¿ (a) In carrying out the purposes of section 301
with respect to drugs the use or misuse of which might result in
drug abuse or dependency, the studies and investigations authorized therein shall include the use and misuse of narcotic drugs and
other drugs. Such studies and investigations shall further include
the quantities of crude opium, coca leaves, and their salts, derivatives, and preparations, and other drugs subject to control under
the Controlled Substances Act and Controlled Substances Import
and Export Act, together with reserves thereof, necessary to supply
the normal and emergency medicinal and scientific requirements of
the United States. The results of studies and investigations of the
quantities of narcotic drugs or other drugs subject to control under
such Acts, together with reserves of such drugs, that are necessary
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