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Fabio 76b8ec33a7 Legal corpus: the complete U.S. Code (59,740 sections, all 53 titles)

Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code
now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 ->
59,740; repo total 105,704 records. Deterministic (byte-identical rerun,
verified on Title 42's 8,356 sections); make check green. make
legal-us-code default now covers every title.

Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>

2026-07-06 10:51:44 -04:00

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42 U.S.C. § 300cc–14 - Evaluation of certain treatments

Text

(a) Establishment of program (1) After consultation with the AIDS Research Advisory Committee established pursuant to section 300cc–3 of this title, the Secretary shall establish a program for the evaluation of drugs that—

(A) are not approved by the Commissioner of Food and Drugs for the purpose of treatments 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 established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs.

(b) Authority with respect to grants and contracts (1) For the purpose of conducting evaluations required in subsection (a), the Secretary may make grants to, and enter into cooperative agreements and contracts with, public and nonprofit private entities.

(2) Nonprofit private entities under paragraph (1) may include nonprofit private organizations that—

(A) are established for the purpose of evaluating treatments 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 shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out pursuant to this section. The Secretary may not provide financial assistance under subsection (b)(1) unless the applicant for such assistance agrees to comply with such guidelines.

(2) The Secretary may establish the guidelines described in paragraph (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

(d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.

(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 ProvisionsA prior section 300cc–14, act July 1, 1944, § 2315, was successively renumbered by subsequent acts and transferred, see section 238l of this title.

Amendments1993—Subsec. (a)(1). Pub. L. 103–43 substituted “AIDS Research Advisory Committee” for “Clinical Research Review Committee” in introductory provisions.

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42 U.S.C. § 300cc–14 - Evaluation of certain treatments

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