PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 889
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Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act. ‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action. ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.—Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress. ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— ‘‘(1) IN GENERAL.—There are authorized to be appropriated to carry out this section— ‘‘(A) $200,000,000 for fiscal year 2008; and ‘‘(B) such sums as are necessary for each of the four succeeding fiscal years. ‘‘(2) AVAILABILITY.—Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.’’. (c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’. (d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by adding at the end the following new subsection: ‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee 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.’’. (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE.—Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) in subparagraph (B), by striking ‘‘and’’ after the semicolon; (ii) in subparagraph (C), by striking the period at the end and inserting ‘‘; and’’; and (iii) by adding at the end the following new subparagraph: ‘‘(D) provide recommendations to the internal review committee created under section 505B(f) of the Federal Food, Drug, and Cosmetic Act regarding the implementation of amendments to sections 505A and 505B of the
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