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From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]
[CITE: 42USC300cc-17]
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A - PUBLIC HEALTH SERVICE
SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE
DEFICIENCY SYNDROME
Part B - Research Authority
-HEAD-
Sec. 300cc-17. Information services
-STATUTE-
(a) Establishment of program
The Secretary shall establish, maintain, and operate a program
with respect to information on research, treatment, and prevention
activities relating to infection with the etiologic agent for
acquired immune deficiency syndrome. The program shall, with
respect to the agencies of the Department of Health and Human
Services, be integrated and coordinated.
(b) Toll-free telephone communications for health care entities
(1) After consultation with the Director of the Office of AIDS
Research, the Administrator of the Health Resources and Services
Administration, and the Director of the Centers for Disease Control
and Prevention, the Secretary shall provide for toll-free telephone
communications to provide medical and technical information with
respect to acquired immune deficiency syndrome to health care
professionals, allied health care providers, and to professionals
providing emergency health services.
(2) Information provided pursuant to paragraph (1) shall include
-
(A) information on prevention of exposure to, and the
transmission of, the etiologic agent for acquired immune
deficiency syndrome; and
(B) information contained in the data banks established in
subsections (c) and (d) of this section.
(c) Data bank on research information
(1) After consultation with the Director of the Office of AIDS
Research, the Director of the Centers for Disease Control and
Prevention, and the National Library of Medicine, the Secretary
shall establish a data bank of information on the results of
research with respect to acquired immune deficiency syndrome
conducted in the United States and other countries.
(2) In carrying out paragraph (1), the Secretary shall collect,
catalog, store, and disseminate the information described in such
paragraph. To the extent practicable, the Secretary shall make
such information available to researchers, physicians, and other
appropriate individuals, of countries other than the United States.
(d) Data bank on clinical trials and treatments
(1) After consultation with the Commissioner of Food and Drugs,
the AIDS Research Advisory Committee established under section
300cc-3 of this title, and the Director of the Office of AIDS
Research, the Secretary shall, in carrying out subsection (a) of
this section, establish a data bank of information on clinical
trials and treatments with respect to infection with the etiologic
agent for acquired immune deficiency syndrome (hereafter in this
section referred to as the ''Data Bank'').
(2) In carrying out paragraph (1), the Secretary shall collect,
catalog, store, and disseminate the information described in such
paragraph. The Secretary shall disseminate such information
through information systems available to individuals infected with
the etiologic agent for acquired immune deficiency syndrome, to
other members of the public, to health care providers, and to
researchers.
(e) Requirements with respect to data bank on clinical trials and
treatments
The Data Bank shall include the following:
(1) A registry of clinical trials of experimental treatments
for acquired immune deficiency syndrome and related illnesses
conducted under regulations promulgated pursuant to section 355
of title 21 that provides a description of the purpose of each
experimental drug protocol either with the consent of the
protocol sponsor, or when a trial to test efficacy begins.
Information provided shall include eligibility criteria and the
location of trial sites, and must be forwarded to the Data Bank
by the sponsor of the trial not later than 21 days after the
approval by the Food and Drug Administration.
(2) Information pertaining to experimental treatments for
acquired immune deficiency syndrome that may be available under a
treatment investigational new drug application that has been
submitted to the Food and Drug Administration pursuant to part
312 of title 21, Code of Federal Regulations. The Data Bank shall
also include information pertaining to the results of clinical
trials of such treatments, with the consent of the sponsor, of
such experimental treatments, including information concerning
potential toxicities or adverse effects associated with the use
or administration of such experimental treatment.
-SOURCE-
(July 1, 1944, ch. 373, title XXIII, Sec. 2317, as added Pub. L.
100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3071;
amended Pub. L. 100-690, title II, Sec. 2617(c), Nov. 18, 1988, 102
Stat. 4240; Pub. L. 102-531, title III, Sec. 312(d)(19), Oct. 27,
1992, 106 Stat. 3505; Pub. L. 103-43, title XX, Sec. 2008(d)(4),
June 10, 1993, 107 Stat. 212.)
-MISC1-
AMENDMENTS
1993 - Subsec. (d)(1). Pub. L. 103-43 substituted ''AIDS Research
Advisory Committee established under section 300cc-3 of this
title'' for ''Clinical Research Review Committee''.
1992 - Subsecs. (b)(1), (c)(1). Pub. L. 102-531 substituted
''Centers for Disease Control and Prevention'' for ''Centers for
Disease Control''.
1988 - Subsec. (e). Pub. L. 100-690 substituted ''data bank on
clinical trials and treatments'' for ''data bank'' in heading.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective immediately after
enactment of Pub. L. 100-607, which was approved Nov. 4, 1988, see
section 2600 of Pub. L. 100-690, set out as a note under section
242m of this title.
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