Page:United States Statutes at Large Volume 92 Part 3.djvu/808

 92 STAT. 3440

PUBLIC LAW 95-622—NOV. 9, 1978

Publication in " (b) RECOMMENDATIONS TO AGENCIES.—(1) W i t h i n 60 days of the Federal Register, date a Federal agency receives a recommendation from the Commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall provide opportunity for interested persons to submit written data, views, and arguments with respect to adoption of the recommendation. " (2) W i t h i n the 180-day period beginning on the date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate, and, to the extent that it determines that— Publication in " (A) such action is not appropriate, the agency shall, within Federal Register. such time period, provide the Commission with, and publish in the Federal Register, a notice of such determination (including an adequate statement of the reasons for the determination), or " (B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and shall notify the Commission of the determination and the action undertaken. Report to President, Congress, and Federal agencies.

"(c)

REPORT ON PROTECTION OF H U M A N S U B J E C T S. — The Commis-

sion shall biennially report to the President, the Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral research. E a c h such report shall include a review of the adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal agencies regarding the protection of human subjects of biomedical or behavioral research which such agencies conduct or support, and (2) of the implementation of such rules, policies, guidelines, and regulations by such agencies, and may include such recommendations for legislation and administrative action as the Commission deems appropriate. Report to " (d) A N N U A L REPORT.—Not later than December 15 of each year President, (beginning with 1979) the Commission shall report to the President, Congress, and the Congress, and appropriate Federal agencies on the activities of the Federal agencies. Commission during the fiscal year ending in such year. E a c h such report shall include a complete list of all recommendations described in subsection (b)(1) made to Federal agencies by the Commission during the fiscal year and the actions taken, p u r s a n t to subsection (b)(2), by the agencies upon such recommendations, and may include such recommendations for legislation and administrative action as the Commission deems appropriate. " (e) PUBLICATIONS.—The Commission may a t any time publish and disseminate to the public reports respecting its activities. " (b) DEEINITIONS.—For purposes of this section: " (1) The term 'Federal agency' means an authority of the government of the United States, but does not include (A) the Congress, (B) the courts of the United States, and (C) the government of the Commonwealth of P u e r to Rico, the government of the District of Columbia, or the government of any territory or possession of the United States. " (2) The term 'protection of human subjects' includes the protection of the health, safety, and privacy of individuals. "ADMINISTRATIVE PROVISIONS

Hearings. 42 USC 300v-2.

" SEC. 1803. (a) HEARINGS.—The Commission may for the purpose of carrying out this title hold such hearings, sit and act at such times

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