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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-14]

 
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-14. Evaluation of certain treatments
 
-STATUTE-
    (a) Establishment of program
      (1) After consultation with the AIDS Research Advisory Committee
    established pursuant to section 300cc-3 of this title, the
    Secretary shall establish a program for the evaluation of drugs
    that -
        (A) are not approved by the Commissioner of Food and Drugs for
      the purpose of treatments with respect to acquired immune
      deficiency syndrome; and
        (B) are being utilized for such purpose by individuals infected
      with the etiologic agent for such syndrome.
      (2) The program established under paragraph (1) shall include
    evaluations of the effectiveness and the risks of the treatment
    involved, including the risks of foregoing treatments with respect
    to acquired immune deficiency syndrome that are approved by the
    Commissioner of Food and Drugs.
    (b) Authority with respect to grants and contracts
      (1) For the purpose of conducting evaluations required in
    subsection (a) of this section, the Secretary may make grants to,
    and enter into cooperative agreements and contracts with, public
    and nonprofit private entities.
      (2) Nonprofit private entities under paragraph (1) may include
    nonprofit private organizations that -
        (A) are established for the purpose of evaluating treatments
      with respect to acquired immune deficiency syndrome; and
        (B) consist primarily of individuals infected with the
      etiologic agent for such syndrome.
    (c) Scientific and ethical guidelines
      (1) The Secretary shall establish appropriate scientific and
    ethical guidelines for the conduct of evaluations carried out
    pursuant to this section.  The Secretary may not provide financial
    assistance under subsection (b)(1) of this section unless the
    applicant for such assistance agrees to comply with such
    guidelines.
      (2) The Secretary may establish the guidelines described in
    paragraph (1) only after consulting with -
        (A) physicians whose clinical practice includes a significant
      number of individuals with acquired immune deficiency syndrome;
        (B) individuals who are infected with the etiologic agent for
      such syndrome; and
        (C) other individuals with appropriate expertise or experience.
    (d) Authorization of appropriations
      For the purpose of carrying out this section, there are
    authorized to be appropriated such sums as may be necessary.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXIII, Sec. 2314, as added Pub. L.
    100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3069;
    amended Pub. L. 103-43, title XX, Sec. 2008(d)(3), June 10, 1993,
    107 Stat. 212.)
 
-MISC1-
                              PRIOR PROVISIONS
      A prior section 300cc-14, act July 1, 1944, Sec. 2315, was
    successively renumbered by subsequent acts and transferred, see
    section 238l of this title.
                                 AMENDMENTS
      1993 - Subsec. (a)(1). Pub. L. 103-43 substituted ''AIDS Research
    Advisory Committee'' for ''Clinical Research Review Committee'' in
    introductory provisions.

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