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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-12]

 
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-12. Use of investigational new drugs with respect to
        acquired immune deficiency syndrome
 
-STATUTE-
    (a) Encouragement of applications with respect to clinical trials
      (1) If, in the determination of the Secretary, there is
    preliminary evidence that a new drug has effectiveness in humans
    with respect to the prevention or treatment of acquired immune
    deficiency syndrome, the Secretary shall, through statements
    published in the Federal Register -
        (A) announce the fact of such determination; and
        (B) with respect to the new drug involved, encourage an
      application for an exemption for investigational use of the new
      drug under regulations issued under section 355(i) of title 21.
      (2)(A) The AIDS Research Advisory Committee established pursuant
    to section 300cc-3 of this title shall make recommendations to the
    Secretary with respect to new drugs appropriate for determinations
    described in paragraph (1).
      (B) The Secretary shall, as soon as is practicable, determine the
    merits of recommendations received by the Secretary pursuant to
    subparagraph (A).
    (b) Encouragement of applications with respect to treatment use in
        circumstances other than clinical trials
      (1) In the case of a new drug with respect to which the Secretary
    has made a determination described in subsection (a) of this
    section and with respect to which an exemption is in effect for
    purposes of section 355(i) of title 21, the Secretary shall -
        (A) as appropriate, encourage the sponsor of the investigation
      of the new drug to submit to the Secretary, in accordance with
      regulations issued under such section, an application to use the
      drug in the treatment of individuals -
          (i) who are infected with the etiologic agent for acquired
        immune deficiency syndrome; and
          (ii) who are not participating in the clinical trials
        conducted pursuant to such exemption; and
        (B) if such an application is approved, encourage, as
      appropriate, licensed medical practitioners to obtain, in
      accordance with such regulations, the new drug from such sponsor
      for the purpose of treating such individuals.
      (2) If the sponsor of the investigation of a new drug described
    in paragraph (1) does not submit to the Secretary an application
    described in such paragraph (relating to treatment use), the
    Secretary shall, through statements published in the Federal
    Register, encourage, as appropriate, licensed medical practitioners
    to submit to the Secretary such applications in accordance with
    regulations described in such paragraph.
    (c) Technical assistance with respect to treatment use
      In the case of a new drug with respect to which the Secretary has
    made a determination described in subsection (a) of this section,
    the Secretary may, directly or through grants or contracts, provide
    technical assistance with respect to the process of -
        (1) submitting to the Secretary applications for exemptions
      described in paragraph (1)(B) of such subsection;
        (2) submitting to the Secretary applications described in
      subsection (b) of this section; and
        (3) with respect to sponsors of investigations of new drugs,
      facilitating the transfer of new drugs from such sponsors to
      licensed medical practitioners.
    (d) ''New drug'' defined
      For purposes of this section, the term ''new drug'' has the
    meaning given such term in section 321 of title 21.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXIII, Sec. 2312, as added Pub. L.
    100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3066;
    amended Pub. L. 103-43, title XX, Sec. 2008(d)(2), June 10, 1993,
    107 Stat. 212.)
 
-MISC1-
                              PRIOR PROVISIONS
      A prior section 300cc-12, act July 1, 1944, Sec. 2313, was
    successively renumbered by subsequent acts and transferred, see
    section 238j of this title.
                                 AMENDMENTS
      1993 - Subsec. (a)(2)(A). Pub. L. 103-43 substituted ''AIDS
    Research Advisory Committee'' for ''AIDS Clinical Research Review
    Committee''.


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