US Code

Public Law 119-102 (07/12/2026)

42 U.S.C. § 300cc–14

Evaluation of certain treatments

Section text and notes

(a)

Establishment of program

(1)
section 300cc–3 of this title After consultation with the AIDS Research Advisory Committee established pursuant to , 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
(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.

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

Editorial Notes

Prior Provisions

lA prior section 300cc–14, act , § 2315, was successively renumbered by subsequent acts and transferred, see section 238 of this title.

Amendments

Pub. L. 103–431993—Subsec. (a)(1). substituted “AIDS Research Advisory Committee” for “Clinical Research Review Committee” in introductory provisions.