Page:United States Statutes at Large Volume 107 Part 1.djvu/159

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PUBLIC LAW 103-43—JUNE 10, 1993

ler General of the United States shall conduct an audit for the purpose of determining—

(1) whether and to what extent such research conducted or supported by the Secretary of Health and Human Services has been conducted in accordance with section 498A of the Public Health Service Act (as added by section 111 of this Act); and

(2) whether and to what extent there have been violations of section 498B of such Act (as added by section 112 of this Act).

(b) REPORT.—Not later than May 19, 1995, the Comptroller General of the United States shall complete the audit required in subsection (a) and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings made pursuant to the audit.


PART III—MISCELLANEOUS REPEALS


SEC. 121. REPEALS.

(a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)42 USC 275. is amended by striking part J.

(b) OTHER REPEALS.—Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.)42 USC 289h.
42 USC 290b.
42 USC 289g.
42 USC 289g.
note.
is amended—

(1) in section 498, by striking subsection (c); and

(2) by striking section 499; and

(3) by redesignating section 499A as section 499.

(c) NULLIFICATION OF CERTAIN PROVISIONS.—The provisions of Executive Order 12806 (57 Fed. Reg. 21589 (May 21, 1992)) shall not have any legal effect. The provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)) shall not have any legal effect.


Subtitle B—Clinical Research Equity Regarding Women and Minorities


PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH


SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

Part G of title IV of the Public Health Service Act, as amended by section 101 of this Act, is amended by inserting after section 492A the following section:

" INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

" SEC. 492B. (a)42 USC 289a-2. REQUIREMENT OF INCLUSION. —

"(1) IN GENERAL.—In conducting or supporting clinical research for purposes of this title, the Director of NIH shall, subject to subsection (b), ensure that—

"(A) women are included as subjects in each project of such research; and

"(B) members of minority groups are included as subjects in such research.