
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[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
 
Sec. 300cc-12. Use of investigational new drugs with respect to 
        acquired immune deficiency syndrome
        

(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.

(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.)


                            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''.
