Page:United States Statutes at Large Volume 102 Part 4.djvu/99

 PUBLIC LAW 100-607—NOV. 4, 1988

102 STAT. 3069

information as the Secretary determines to be necessary to cany out this section. "(e) AUTHORIZATION OF APPROPRIATIONS.—

"(1) For the purpose of carrying out subsection (JbXl), there are authorized to be appropriated such sums as may be necessary for each of thefiscalyears 1989 through 1991. "(2) For the purpose of carrying out subsection (b)(2), there are authorized to be appropriated such sums as may be necessary for each of thefiscalyears 1989 through 1991. ' ^ E C 2314. EVALUATION OF CERTAIN TREATMENTS. „.. _ _. (a) ESTABTJSHMKNT OF PROGRAM.—

"(1) After consultation with the Clinical Research Review Committee established pursuant to section 2304, 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 forgoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs. "(b) AUTHORITT WITH RBSPBCT 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 ^ndrome; and "(B) consist primarily of individuals infected with the etiologic agent for such i^yndrome. "(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)(l) 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 witii acquired immune defideacy syndrome; "(B) individuals who are infected with the etiologic agent for such syndioiae; and "(Q other individuals with appropriate expertise or experience. carrying out this section, there are authorized to be appropriated sudi sums as may be necessary.
 * Xd) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

42 USC 300CC-14.

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