
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300cc-14]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
  SUBCHAPTER XXI--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY 
                                SYNDROME
 
                       Part B--Research Authority
 
Sec. 300cc-14. Evaluation of certain treatments


(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) of this section, 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) of this section 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, title XXIII, Sec. 2314, as added Pub. L. 100-
607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3069; amended Pub. 
L. 103-43, title XX, Sec. 2008(d)(3), June 10, 1993, 107 Stat. 212.)


                            Prior Provisions

    A prior section 300cc-14, act July 1, 1944, Sec. 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.
