---
kind: "section"
citation: "42 U.S.C. § 300cc–12"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300cc–12"
heading: "Use of investigational new drugs with respect to acquired immune deficiency syndrome"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300cc-12"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter XXI — Research with Respect to Acquired Immune Deficiency Syndrome"
  - "Part B — Research Authority"
---

# §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](/usc/42/201.md?p=c), there is preliminary evidence that a new [drug](/usc/42/11851.md?p=4) has effectiveness in humans with respect to the prevention or [treatment](/usc/42/11851.md?p=11) of acquired immune deficiency syndrome, the [Secretary](/usc/42/201.md?p=c) shall, through statements published in the Federal Register—
    - (A) announce the fact of such determination; and
    - (B) with respect to the new [drug](/usc/42/11851.md?p=4) involved, encourage an application for an exemption for investigational use of the new [drug](/usc/42/11851.md?p=4) under [regulations](/usc/42/201.md?p=d) issued under [section 355(i) of title 21](/usc/21/355.md?p=i).
  - (2)
    - (A) The AIDS Research [Advisory Committee](/usc/42/17061.md?p=2) established pursuant to [section 300cc–3 of this title](/usc/42/300cc–3.md) shall make recommendations to the [Secretary](/usc/42/201.md?p=c) with respect to new [drugs](/usc/42/11851.md?p=4) appropriate for determinations described in [paragraph (1)](#a-1).
    - (B) The [Secretary](/usc/42/201.md?p=c) shall, as soon as is practicable, determine the merits of recommendations received by the [Secretary](/usc/42/201.md?p=c) pursuant to [subparagraph (A)](#a-2-A).
- (b) **Encouragement of applications with respect to treatment use in circumstances other than clinical trials—**
  - (1) In the case of a new [drug](/usc/42/11851.md?p=4) with respect to which the [Secretary](/usc/42/201.md?p=c) has made a determination described in [subsection (a)](#a) and with respect to which an exemption is in effect for purposes of [section 355(i) of title 21](/usc/21/355.md?p=i), the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) as appropriate, encourage the sponsor of the investigation of the new [drug](/usc/42/11851.md?p=4) to submit to the [Secretary](/usc/42/201.md?p=c), in accordance with [regulations](/usc/42/201.md?p=d) issued under such section, an application to use the [drug](/usc/42/11851.md?p=4) in the [treatment](/usc/42/11851.md?p=11) 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](/usc/42/201.md?p=d), the new [drug](/usc/42/11851.md?p=4) from such sponsor for the purpose of treating such individuals.
  - (2) If the sponsor of the investigation of a new [drug](/usc/42/11851.md?p=4) described in [paragraph (1)](#b-1) does not submit to the [Secretary](/usc/42/201.md?p=c) an application described in such paragraph (relating to [treatment](/usc/42/11851.md?p=11) use), the [Secretary](/usc/42/201.md?p=c) shall, through statements published in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit to the [Secretary](/usc/42/201.md?p=c) such applications in accordance with [regulations](/usc/42/201.md?p=d) described in such paragraph.
- (c) **Technical assistance with respect to treatment use—** In the case of a new [drug](/usc/42/11851.md?p=4) with respect to which the [Secretary](/usc/42/201.md?p=c) has made a determination described in [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) may, directly or through grants or contracts, provide technical assistance with respect to the process of—
  - (1) submitting to the [Secretary](/usc/42/201.md?p=c) applications for exemptions described in paragraph (1)(B) of such subsection;
  - (2) submitting to the [Secretary](/usc/42/201.md?p=c) applications described in [subsection (b)](#b); and
  - (3) with respect to sponsors of investigations of new [drugs](/usc/42/11851.md?p=4), facilitating the transfer of new [drugs](/usc/42/11851.md?p=4) from such sponsors to licensed medical practitioners.
- (d) **“New drug” defined—** For purposes of this section, the term “new [drug](/usc/42/11851.md?p=4)” has the meaning given such term in [section 321 of title 21](/usc/21/321.md).

## Source credit

(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.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 300cc–12, act July 1, 1944, § 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”.