PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 885
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‘‘(A) the availability or scope of exclusivity under this section; ‘‘(B) the availability or scope of exclusivity under section 505 for pediatric formulations; ‘‘(C) the question of the eligibility for approval of any application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(F); or ‘‘(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505. ‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later than 3 years after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute of Medicine to conduct a study and report to Congress regarding the written requests made and the studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to review a representative sample of requests made and studies conducted pursuant to this section in order to conduct such study. Such study shall— ‘‘(1) review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c); ‘‘(2) review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and labeling changes made as a result of such studies; ‘‘(3) review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, and ethical issues in pediatric clinical trials; ‘‘(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 505B; and ‘‘(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics. ‘‘(q) SUNSET.—A drug may not receive any 6-month period under subsection (b) or (c) unless— ‘‘(1) on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug; ‘‘(2) on or before October 1, 2012, an application for the drug is accepted for filing under section 505(b); and ‘‘(3) all requirements of this section are met.’’. (2) APPLICABILITY.— (A) IN GENERAL.—The amendment made by this subsection shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment of this Act. (B) CERTAIN WRITTEN REQUESTS.—A written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been accepted and for which no determination under subsection (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as
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