g PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS 1 IN GENERALSection 351 of the

G pediatric studies of biological products 1 in

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Unformatted text preview: (g) PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS.— (1) IN GENERAL.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following: ‘‘(m) PEDIATRIC STUDIES.— ‘‘(1) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (i), (j), (k), (l), (p), and (q) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act. ‘‘(2) MARKET EXCLUSIVITY FOR NEW BIOLOGICAL PROD-UCTS.—If, prior to approval of an application that is submitted under subsection (a), the Secretary determines that information relating to the use of a new biological product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act— ‘‘(A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6 months rather than 4 years and 12 years and 6 months rather than 12 years; and ‘‘(B) if the biological product is designated under section 526 for a rare disease or condition, the period for such biological product referred to in section 527(a) is deemed to be 7 years and 6 months rather than 7 years. ‘‘(3) MARKET EXCLUSIVITY FOR ALREADY-MARKETED BIOLOGICAL PRODUCTS.—If the Secretary determines that information relating to the use of a licensed biological product in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under subsection (a) for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accord-ance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act— VerDate Nov 24 2008 18:12 Apr 23, 2010 Jkt 000000 PO 00000 Frm 00723 Fmt 6655 Sfmt 6501 C:\TEMP\PPACA-CONSOLIDATED_003.XML HOLCPC April 23, 2010 (6:12 p.m.) F:\P11\NHI\COMP\PPACA-CONSOLIDATED_003.XML f:\VHLC\042310\042310.200.xml (466008|3) Ppaca & Hcera; Public Laws 111-148 & 111-152: Consolidated Print—724 ‘‘(A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6 months rather than 4 years and 12 years and 6 months...
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