---
kind: "section"
citation: "42 U.S.C. § 300cc–14"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300cc–14"
heading: "Evaluation of certain treatments"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300cc-14"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter XXI — Research with Respect to Acquired Immune Deficiency Syndrome"
  - "Part B — Research Authority"
---

# §300cc–14. Evaluation of certain treatments

- (a) **Establishment of program—**
  - (1) After consultation with 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), the [Secretary](/usc/42/201.md?p=c) shall establish a [program](/usc/42/274l–1.md?p=4) for the evaluation of [drugs](/usc/42/11851.md?p=4) that—
    - (A) are not approved by the Commissioner of Food and [Drugs](/usc/42/11851.md?p=4) for the purpose of [treatments](/usc/42/11851.md?p=11) 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](/usc/42/274l–1.md?p=4) established under [paragraph (1)](#a-1) shall include evaluations of the effectiveness and the risks of the [treatment](/usc/42/11851.md?p=11) involved, including the risks of foregoing [treatments](/usc/42/11851.md?p=11) with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and [Drugs](/usc/42/11851.md?p=4).
- (b) **Authority with respect to grants and contracts—**
  - (1) For the purpose of conducting evaluations required in [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) may make grants to, and enter into cooperative agreements and contracts with, public and [nonprofit](/usc/42/300s–3.md?p=3) private entities.
  - (2) [Nonprofit](/usc/42/300s–3.md?p=3) private entities under [paragraph (1)](#b-1) may include [nonprofit](/usc/42/300s–3.md?p=3) private organizations that—
    - (A) are established for the purpose of evaluating [treatments](/usc/42/11851.md?p=11) 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](/usc/42/201.md?p=c) shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out pursuant to this section. The [Secretary](/usc/42/201.md?p=c) may not provide financial assistance under [subsection (b)(1)](#b-1) unless the applicant for such assistance agrees to comply with such guidelines.
  - (2) The [Secretary](/usc/42/201.md?p=c) may establish the guidelines described in [paragraph (1)](#c-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 credit

(July 1, 1944, ch. 373, title XXIII, § 2314, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3069; amended Pub. L. 103–43, title XX, § 2008(d)(3), June 10, 1993, 107 Stat. 212.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 300cc–14, act July 1, 1944, § 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.