Page:United States Statutes at Large Volume 115 Part 2.djvu/434

 115 STAT. 1418 PUBLIC LAW 107-109—JAN. 4, 2002 (ii) by striking subparagraph (C) and inserting the following: "(C) The ex officio members of the Board under subparagraph (B) shall appoint to the Board individuals from among a list of candidates to be provided by the National Academy of Science. Such appointed members shall include— "(i) representatives of the general biomedical field; "(ii) representatives of experts in pediatric medicine and research; "(iii) representatives of the general biobehavioral field, which may include experts in biomedical ethics; and "(iv) representatives of the general public, which may include representatives of affected industries."; and (B) in paragraph (2), by realigning the margin of subparagraph (B) to align with subparagraph (A); (4) in subsection (k)(9)— (A) by striking "The Foundation" and inserting the following: "(A) IN GENERAL. —The Foundation"; and (B) by adding at the end the following: "(B) GIFTS, GRANTS, AND OTHER DONATIONS.— "(i) IN GENERAL.—Gifts, grants, and other donations to the Foundation may be designated for pediatric research and studies on drugs, and ftmds so designated shall be used solely for grants for research and studies under subsection (c)(1)(C). "(ii) OTHER GIFTS.— Other gifts, grants, or donations received by the Foundation and not described in clause (i) may also be used to support such pediatric research and studies. "(iii) REPORT. —The recipient of a grant for research and studies shall agree to provide the Director of the National Institutes of Health and the Commissioner of Food and Drugs, at the conclusion of the research and studies— "(I) a report describing the results of the research and studies; and "(II) all data generated in connection with the research and studies. "(iv) ACTION BY THE COMMISSIONER OF FOOD AND DRUGS. —The Commissioner of Food and Drugs shall take appropriate action in response to a report received under clause (iii) in accordance with paragraphs (7) through (12) of section 4091(c), including negotiating with the holders of approved applications for the drugs studied for any labeling changes that the Commissioner determines to be appropriate and requests the holders to make. "(C) APPLICABILITY.— Subparagraph (A) does not apply to the program described in subsection (c)(l)(C)."; (5) by redesignating subsections (f) through (m) as subsections (e) through (1), respectively; (6) in subsection (h)(ll) (as so redesignated), by striking "solicit" and inserting "solicit,"; and

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