NIDA's Data Collection Authority

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 1
NIDA’s Data Collection Authority

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

§ 285o

TITLE 42—THE PUBLIC HEALTH AND WELFARE

1980—Subsec. (a). Pub. L. 96–180, § 16(a), substituted:
in first sentence ‘‘biomedical, behavioral, and social issues related to alcoholism and alcohol abuse’’ for ‘‘alcohol problems’’; in par. (1)(B) ‘‘facilities (including
laboratory, reference, and data analysis facilities) to
carry out the research plan contained in the application’’ for ‘‘laboratory facilities and reference services
(including reference services that will afford access to
scientific alcohol literature)’’; and in par. (1)(E) ‘‘medical and osteopathic, nursing, social work, and other
specialized graduate students; and’’ for ‘‘medical and
osteopathic students and physicians;’’, and added par.
(1)(F).
Subsec. (b). Pub. L. 96–180, § 16(b), increased annual
grant limitation to $1,500,000 from $1,000,000.
Subsec. (c). Pub. L. 96–180, § 16(c), authorized appropriation of $8,000,000 and $9,000,000 for fiscal years ending Sept. 30, 1980, and 1981.
1978—Subsec. (a). Pub. L. 95–622 inserted provision following par. (2) relating to approval of applications
under this subsection by the Secretary in a manner
which results in equitable geographic distribution of
Centers.
EFFECTIVE DATE OF 1992 AMENDMENTS
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
SUBPART 15—NATIONAL INSTITUTE ON DRUG ABUSE

§ 285o. Purpose of Institute
(a) In general
The general purpose of the National Institute
on Drug Abuse (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and
support of biomedical and behavioral research,
health services research, research training, and
health information dissemination with respect
to the prevention of drug abuse and the treatment of drug abusers.
(b) Research program
The research program established under this
subpart shall encompass the social, behavioral,
and biomedical etiology, mental and physical
health consequences, and social and economic
consequences of drug abuse. In carrying out the
program, the Director of the Institute shall give
special consideration to projects relating to
drug abuse among women (particularly with respect to pregnant women).
(c) Collaboration
The Director of the Institute shall collaborate
with the Substance Abuse and Mental Health
Services Administration in focusing the services
research activities of the Institute and in disseminating the results of such research to
health professionals and the general public.
(July 1, 1944, ch. 373, title IV, § 464L, as added
Pub. L. 102–321, title I, § 123(a), July 10, 1992, 106
Stat. 360; amended Pub. L. 102–352, § 2(a)(3), Aug.
26, 1992, 106 Stat. 938; Pub. L. 109–482, title I,
§ 103(b)(33), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (d). Pub. L. 109–482 struck out subsec.
(d) which related to authorization of appropriations
and allocation for health services research.

Page 524

1992—Subsec. (d)(1). Pub. L. 102–352 inserted ‘‘other
than section 285o–4 of this title,’’ after ‘‘this subpart,’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate
Director for Prevention who shall be responsible
for the full-time coordination and promotion of
the programs in the Institute concerning the
prevention of drug abuse. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their
professional training or expertise are experts in
drug abuse and the prevention of such abuse.
(b) Report
The Associate Director for Prevention shall
prepare for inclusion in the biennial report made
under section 284b 1 of this title a description of
the prevention activities of the Institute, including a description of the staff and resources
allocated to those activities.
(July 1, 1944, ch. 373, title IV, § 464M, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 361.)
REFERENCES IN TEXT
Section 284b of this title, referred to in subsec. (b),
was repealed by Pub. L. 109–482, title I, § 104(b)(1)(C),
Jan. 15, 2007, 120 Stat. 3693.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–2. Drug Abuse Research Centers
(a) Authority
The Director of the Institute may designate
National Drug Abuse Research Centers for the
purpose of interdisciplinary research relating to
drug abuse and other biomedical, behavioral,
and social issues related to drug abuse. No entity may be designated as a Center unless an application therefore has been submitted to, and
approved by, the Secretary. Such an application
shall be submitted in such manner and contain
such information as the Secretary may reasonably require. The Secretary may not approve
such an application unless—
(1) the application contains or is supported
by reasonable assurances that—
1 See

References in Text note below.

Population Assessment of Tobacco and Health (PATH) Study (NIDA)
Page 525

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social, and related disciplines,
long-term research on drug abuse and to provide coordination of such research among
such disciplines;
(B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis facilities) to carry
out the research plan contained in the application;
(C) the applicant has facilities and personnel to provide training in the prevention and
treatment of drug abuse;
(D) the applicant has the capacity to train
predoctoral and postdoctoral students for
careers in research on drug abuse;
(E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse for undergraduate and
graduate students, and medical and osteopathic, nursing, social work, and other specialized graduate students; and
(F) the applicant has the capacity to conduct programs of continuing education in
such medical, legal, and social service fields
as the Secretary may require.1
(2) the application contains a detailed fiveyear plan for research relating to drug abuse.
(b) Grants
The Director of the Institute shall, under such
conditions as the Secretary may reasonably require, make annual grants to Centers which
have been designated under this section. No
funds provided under a grant under this subsection may be used for the purchase of any land
or the purchase, construction, preservation, or
repair of any building. For the purposes of the
preceding sentence, the term ‘‘construction’’ has
the meaning given that term by section 292a(1) 2
of this title.
(c) Drug abuse and addiction research
(1) Grants or cooperative agreements
The Director of the Institute may make
grants or enter into cooperative agreements to
expand the current and ongoing interdisciplinary research and clinical trials with treatment centers of the National Drug Abuse
Treatment Clinical Trials Network relating to
drug abuse and addiction, including related
biomedical, behavioral, and social issues.
(2) Use of funds
Amounts made available under a grant or
cooperative agreement under paragraph (1) for
drug abuse and addiction may be used for research and clinical trials relating to—
(A) the effects of drug abuse on the human
body, including the brain;
(B) the addictive nature of drugs and how
such effects differ with respect to different
individuals;
(C) the connection between drug abuse and
mental health;
(D) the identification and evaluation of
the most effective methods of prevention of
drug abuse and addiction;
1 So

in original. The period probably should be ‘‘; and’’.
References in Text note below.

2 See

§ 285o–3

(E) the identification and development of
the most effective methods of treatment of
drug addiction, including pharmacological
treatments;
(F) risk factors for drug abuse;
(G) effects of drug abuse and addiction on
pregnant women and their fetuses; and
(H) cultural, social, behavioral, neurological, and psychological reasons that individuals abuse drugs, or refrain from abusing
drugs.
(3) Research results
The Director shall promptly disseminate research results under this subsection to Federal, State, and local entities involved in combating drug abuse and addiction.
(July 1, 1944, ch. 373, title IV, § 464N, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 361; amended Pub. L. 102–352, § 2(a)(4), Aug.
26, 1992, 106 Stat. 938; Pub. L. 106–310, div. B, title
XXXVI, § 3631, Oct. 17, 2000, 114 Stat. 1235; Pub.
L. 107–273, div. B, title II, § 2203, Nov. 2, 2002, 116
Stat. 1794; Pub. L. 109–482, title I, § 103(b)(34),
Jan. 15, 2007, 120 Stat. 3688.)
REFERENCES IN TEXT
Section 292a of this title, referred to in subsec. (b),
was in the original a reference to section 701 of act July
1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L.
102–408, title I, § 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L.
102–408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702,
relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see sections 292o and 295p of this title.
AMENDMENTS
2007—Subsec. (c)(4). Pub. L. 109–482 struck out par. (4)
which authorized appropriations and provided they
were supplemental to other funding of research on drug
abuse.
2002—Subsec. (c). Pub. L. 107–273 amended heading
and text of subsec. (c) generally, substituting provisions relating to grants or cooperative agreements for
research and clinical trials relating to drug abuse and
addiction for similar provisions relating to grants or
cooperative agreements for research and clinical trials
relating to methamphetamine abuse and addiction.
2000—Subsec. (c). Pub. L. 106–310 added subsec. (c).
1992—Subsec. (b). Pub. L. 102–352 substituted ‘‘292a(1)’’
for ‘‘292a(2)’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–352 effective immediately
upon effectuation of amendment made by Pub. L.
102–321, see section 3(1) of Pub. L. 102–352, set out as a
note under section 285n of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.

§ 285o–3. Office on AIDS
The Director of the Institute shall establish
within the Institute an Office on AIDS. The Of-

Population Assessment of Tobacco and Health (PATH) Study (NIDA)
§ 285o–4

TITLE 42—THE PUBLIC HEALTH AND WELFARE

fice shall be responsible for the coordination of
research and determining the direction of the
Institute with respect to AIDS research related
to—
(1) primary prevention of the spread of HIV,
including transmission via drug abuse;
(2) drug abuse services research; and
(3) other matters determined appropriate by
the Director.
(July 1, 1944, ch. 373, title IV, § 464O, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 362.)
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
STUDY BY NATIONAL ACADEMY OF SCIENCES
Section 706 of Pub. L. 102–321 directed Secretary of
Health and Human Services to contract for a study or
studies relating to programs that provide both sterile
hypodermic needles and bleach to individuals in order
to reduce the risk of contracting acquired immune deficiency syndrome or related conditions, in order to determine extent to which such programs promote the
abuse of drugs or otherwise altered any behaviors constituting a substantial risk of contracting AIDS or
hepatitus, or of transmitting such conditions, and further directed Secretary to ensure that a report is submitted to Congress on the results of this study not
later than 18 months after July 10, 1992.

§ 285o–4. Medication Development Program
(a) Establishment
There is established in the Institute a Medication Development Program through which the
Director of such Institute shall—
(1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate the approval process
of drug abuse treatments;
(2) encourage and promote (through grants,
contracts, international collaboration, or
otherwise) expanded research programs, investigations, experiments, community trials, and
studies, into the development and use of medications to treat drug addiction;
(3) establish or provide for the establishment
of research facilities;
(4) report on the activities of other relevant
agencies relating to the development and use
of pharmacotherapeutic treatments for drug
addiction;
(5) collect, analyze, and disseminate data
useful in the development and use of
pharmacotherapeutic treatments for drug addiction and collect, catalog, analyze, and disseminate through international channels, the
results of such research;
(6) directly or through grants, contracts, or
cooperative agreements, support training in
the fundamental sciences and clinical disciplines related to the pharmacotherapeutic
treatment of drug abuse, including the use of
training stipends, fellowships, and awards
where appropriate; and
(7) coordinate the activities conducted under
this section with related activities conducted
within the National Institute on Alcohol
Abuse and Alcoholism, the National Institute

Page 526

of Mental Health, and other appropriate institutes and shall consult with the Directors of
such Institutes.
(b) Duties
In carrying out the activities described in subsection (a) of this section, the Director of the Institute—
(1) shall collect and disseminate through
publications and other appropriate means, information pertaining to the research and
other activities under this section;
(2) shall make grants to or enter into contracts and cooperative agreements with individuals and public and private entities to further the goals of the program;
(3) may, in accordance with section 289e of
this title, and in consultation with the National Advisory Council on Drug Abuse, acquire, construct, improve, repair, operate, and
maintain pharmacotherapeutic research centers, laboratories, and other necessary facilities and equipment, and such other real or personal property as the Director determines necessary, and may, in consultation with such
Advisory Council, make grants for the construction or renovation of facilities to carry
out the purposes of this section;
(4) may accept voluntary and uncompensated services;
(5) may accept gifts, or donations of services, money, or property, real, personal, or
mixed, tangible or intangible; and
(6) shall take necessary action to ensure
that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and
the other scientific, medical, and biomedical
disciplines and organizations nationally and
internationally.
(c) Report
(1) In general
Not later than December 31, 1992, and each
December 31 thereafter, the Director of the Institute shall submit to the Office of National
Drug Control Policy established under section
1501 1 of title 21 a report, in accordance with
paragraph (3), that describes the objectives
and activities of the program assisted under
this section.
(2) National Drug Control Strategy
The Director of National Drug Control Policy shall incorporate, by reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy
submitted the following February 1 under section 1504 1 of title 21.
(d) ‘‘Pharmacotherapeutics’’ defined
For purposes of this section, the term
‘‘pharmacotherapeutics’’ means medications
used to treat the symptoms and disease of drug
abuse, including medications to—
(1) block the effects of abused drugs;
(2) reduce the craving for abused drugs;
(3) moderate or eliminate withdrawal symptoms;
(4) block or reverse the toxic effect of abused
drugs; or
1 See

References in Text note below.

Population Assessment of Tobacco and Health (PATH) Study (NIDA)
Page 527

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(5) prevent relapse in persons who have been
detoxified from drugs of abuse.
(July 1, 1944, ch. 373, title IV, § 464P, as added
Pub. L. 102–321, title I, § 123(b), July 10, 1992, 106
Stat. 362; amended Pub. L. 103–43, title XX,
§ 2008(b)(10), June 10, 1993, 107 Stat. 211; Pub. L.
109–482, title I, § 103(b)(35), Jan. 15, 2007, 120 Stat.
3688.)
REFERENCES IN TEXT
Sections 1501 and 1504 of title 21, referred to in subsec.
(c), were repealed by Pub. L. 100–690, title I, § 1009, Nov.
18, 1988, 102 Stat. 4188, as amended.
AMENDMENTS
2007—Subsec. (e). Pub. L. 109–482 struck out heading
and text of subsec. (e). Text read as follows: ‘‘For the
purpose of carrying out this section, there are authorized to be appropriated $85,000,000 for fiscal year 1993,
and $95,000,000 for fiscal year 1994.’’
1993—Subsec. (b)(6). Pub. L. 103–43 substituted ‘‘Institute’’ for ‘‘Administration’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or
subsequent fiscal years, see section 109 of Pub. L.
109–482, set out as a note under section 281 of this title.
EFFECTIVE DATE
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c),
(d) of Pub. L. 102–321, set out as an Effective Date of
1992 Amendment note under section 236 of this title.
REPORT BY INSTITUTE ON MEDICINE
Section 701 of Pub. L. 102–321 directed Secretary of
Health and Human Services to enter into a contract
with a public or nonprofit private entity to conduct a
study concerning (1) role of the private sector in development of anti-addiction medications, including legislative proposals designed to encourage private sector
development of such medications, (2) process by which
anti-addiction medications receive marketing approval
from Food and Drug Administration, including an assessment of feasibility of expediting marketing approval process in a manner consistent with maintaining safety and effectiveness of such medications, (3)
with respect to pharmacotherapeutic treatments for
drug addiction (A) recommendations with respect to a
national strategy for developing such treatments and
improvements in such strategy, (B) state of the scientific knowledge concerning such treatments, and (C)
assessment of progress toward development of safe, effective pharmacological treatments for drug addiction,
and (4) other related information determined appropriate by the authors of the study, and to submit to
Congress a report of the results of such study not later
than 18 months after July 10, 1992.
SUBPART 16—NATIONAL INSTITUTE OF MENTAL
HEALTH

§ 285p. Purpose of Institute
(a) In general
The general purpose of the National Institute
of Mental Health (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and
support of biomedical and behavioral research,
health services research, research training, and
health information dissemination with respect
to the cause, diagnosis, treatment, control and
prevention of mental illness.
(b) Research program
The research program established under this
subpart shall include support for biomedical and

§ 285p

behavioral neuroscience and shall be designed to
further the treatment and prevention of mental
illness, the promotion of mental health, and the
study of the psychological, social and legal factors that influence behavior.
(c) Collaboration
The Director of the Institute shall collaborate
with the Administrator of the Substance Abuse
and Mental Health Services Administration in
focusing the services research activities of the
Institute and in disseminating the results of
such research to health professionals and the
general public.
(d) Information with respect to suicide
(1) In general
The Director of the Institute shall—
(A) develop and publish information with
respect to the causes of suicide and the
means of preventing suicide; and
(B) make such information generally
available to the public and to health professionals.
(2) Youth suicide
Information described in paragraph (1) shall
especially relate to suicide among individuals
under 24 years of age.
(e) Associate Director for Special Populations
(1) In general
The Director of the Institute shall designate
an Associate Director for Special Populations.
(2) Duties
The Associate Director for Special Populations shall—
(A) develop and coordinate research policies and programs to assure increased emphasis on the mental health needs of women
and minority populations;
(B) support programs of basic and applied
social and behavioral research on the mental
health problems of women and minority populations;
(C) study the effects of discrimination on
institutions and individuals, including majority institutions and individuals;
(D) support and develop research designed
to eliminate institutional discrimination;
and
(E) provide increased emphasis on the concerns of women and minority populations in
training programs, service delivery programs, and research endeavors of the Institute.
(July 1, 1944, ch. 373, title IV, § 464R, as added
Pub. L. 102–321, title I, § 124(a), July 10, 1992, 106
Stat. 364; amended Pub. L. 102–352, § 2(a)(5), Aug.
26, 1992, 106 Stat. 938; Pub. L. 109–482, title I,
§ 103(b)(36), Jan. 15, 2007, 120 Stat. 3688.)
AMENDMENTS
2007—Subsec. (f). Pub. L. 109–482 struck out subsec. (f)
which authorized appropriations and provided that at
least 15% of the appropriated amounts were to carry
out health services research relating to mental health.
1992—Subsec. (f)(1). Pub. L. 102–352 struck out ‘‘other
than section 285o–4 of this title’’ after ‘‘this subpart’’.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109–482 applicable only with
respect to amounts appropriated for fiscal year 2007 or