121 STAT. 890
PUBLIC LAW 110–85—SEPT. 27, 2007
Federal Food, Drug, and Cosmetic Act with respect to the treatment of pediatric cancers.’’; and (B) by adding at the end the following new paragraph: ‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee Act, the Subcommittee shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007.’’; and (2) in subsection (d), by striking ‘‘2003’’ and inserting ‘‘2009’’. (f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN DRUG PRODUCTS.— (1) IN GENERAL.—Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the ‘‘Administrative Procedure Act’’) and any other provision of law, the proposed rule issued by the Commissioner of Food and Drugs entitled ‘‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products,’’ 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on January 1, 2008, unless such Commissioner issues the final rule before such date. (2) LIMITATION.—The proposed rule that takes effect under subsection (a), or the final rule described under subsection (a), shall, notwithstanding section 17(a) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply to a drug— (A) for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); (B) that is not described under section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and (C) the packaging of which includes a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug. SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
(a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Section 452G(2) of the Public Health Service Act (42 U.S.C. 285g– 10(2)) is amended by adding before the period at the end the following: ‘‘, including pediatric pharmacological research’’. (b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) is amended by inserting ‘‘including pediatric pharmacological research,’’ after ‘‘pediatric research,’’.
TITLE VI—REAGAN-UDALL FOUNDATION SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.
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(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:
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