Page:United States Statutes at Large Volume 115 Part 2.djvu/424

 115 STAT. 1408 PUBLIC LAW 107-109-JAN. 4, 2002 Public Law 107-109 107th Congress An Act Jan. 4, 2002 To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and [S. 1789] efficacy of pharmaceuticals for children. Be it enacted by the Senate and House of Representatives of Best the United States of America in Congress assembled, Z"Sen"£t. SECTION 1. SHORT TITLE. 21 USC 301 note. This Act may be cited as the "Best Pharmaceuticals for Children Act". SEC. 2. PEDIATRIC STUDIES OF ALREADY-MARKETED DRUGS. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended— (1) by striking subsection (b); and (2) in subsection (c)— (A) by inserting after "the Secretary" the following: "determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and"; and (B) by striking "concerning a drug identified in the list described in subsection (b)". SEC. 3. RESEARCH FUND FOR THE STUDY OF DRUGS. Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended— (1) by redesignating the second section 409C, relating to clinical research (42 U.S.C. 284k), as section 409G; (2) by redesignating the second section 409D, relating to enhancement awards (42 U.S.C. 2841), as section 409H; and (3) by adding at the end the following: 42 USC 284m. " SEC. 4091. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. "(a) LIST OF DRUGS FOR WHICH PEDIATRIC STUDIES ARE NEEDED.— "(1) IN GENERAL.—Not later than one year after the date of enactment of this section, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop, prioritize, and publish an annual list of approved drugs for which— "(A)(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355CJ)); "(ii) there is a submitted application that could be approved under the criteria of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3550"));

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