42 U.S. Code § 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) 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) 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—
(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;
Source(July 1, 1944, ch. 373, title XXIII, § 2312, as added Pub. L. 100–607, title II, § 201(4),Nov. 4, 1988, 102 Stat. 3066; amended Pub. L. 103–43, title XX, § 2008(d)(2),June 10, 1993, 107 Stat. 212.)
A prior section 300cc–12, act July 1, 1944, § 2313, was successively renumbered by subsequent acts and transferred, see section 238j of this title.
1993—Subsec. (a)(2)(A). Pub. L. 103–43substituted “AIDS Research Advisory Committee” for “AIDS Clinical Research Review Committee”.