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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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