Page:United States Statutes at Large Volume 100 Part 1.djvu/423

 PUBLIC LAW 99-272—APR. 7, 1986

100 STAT. 387

(A) shall, on such day, submit to the appropriate committees of the Congress a report describing the reasons why the Director has not approved such a protocol; and (B) shall, each 60 days thereafter until such a protocol is approved, submit to such committees an updated report on the report required by clause (A). (d) OTA MONITORING OF COMPLIANCE.—(1) In order to ensure compliance with the protocol approved under subsection (b)(1), the Director shall monitor the conduct of the study under subsection (a). (2)(A) The Director shall submit to the appropriate committees of the Congress, at each of the times specified in subparagraph (B), a report on the Director's monitoring of the conduct of the study pursuant to paragraph (1). (B) A report shall be submitted under subparagraph (A)— (i) before the end of the 6-month period beginning on the date on which the Director approves the protocol referred to in paragraph (1); (ii) before the end of the 12-month period beginning on such date; and (iii) annually thereafter until the study is completed or terminated. (e) DURATION OF STUDY.—The study conducted pursuant to subsection (a) shall be continued for as long after the date on which the first report is submitted under subsection (fKD as the Administrator determines that there is a reasonable possibility of developing, through such study, significant new information on the health effects described in subsection (a)(1). (f) REPORTS.—(1) Not later than 24 months after the date of the approval of the protocol pursuant to subsection (b)(l) and annually thereafter, the Administrator shall submit to the appropriate committees of the Congress a report containing— (A) a description of the results obtained, before the date of such report, under the study conducted pursuant to subsection (a); and (B) any administrative actions or recommended legislation, or both, and any additional comments which the Administrator considers appropriate in light of such results. (2) Not later than 90 days after the date on which each report required by paragraph (1) is submitted, the Administrator shall publish in the Federal Register, for public review and comment, a description of any action that the Administrator plans or proposes to take with respect to programs administered by the Veterans' Administration based on— (A) the results described in such report; (B) the comments and recommendations received on that report; and (C) any other available pertinent information. Each such description shall include a justification or rationale for the planned or proposed action. (g) DEFINITIONS.—For the purposes of this section: (1) The term "gender-specific health effects" includes— (A) effects on female reproductive capacity and reproductive organs; (B) effects on reproductive outcomes; "••'' (C) effects on female-specific organs and tissues; and (D) other effects unique to the physiology of females.

Reports,

Federal Register, publication.

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