Page:United States Statutes at Large Volume 115 Part 2.djvu/427

 PUBLIC LAW 107-109^JAN. 4, 2002 115 STAT. 1411 under subparagraph (A), the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee shall— "(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and "(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any. "(9) FDA DETERMINATION. —Not later than 30 days after Deadline, receiving a recommendation from the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate. "(10) FAILURE TO AGREE.—If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). "(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 Subcommittee of the Anti-Infective Drugs 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. "(12) RECOMMENDATION FOR FORMULATION CHANGES. — If a pediatric study completed under public contract indicates that a formulation change is necessary and the Secretary agrees, the Secretary shall send a nonbinding letter of recommendation regarding that change to each holder of an approved application. "(d) AUTHORIZATION OF APPROPRIATIONS.— "(1) IN GENERAL.— T here are authorized to be appropriated to carry out this section— "(A) $200,000,000 for fiscal year 2002; and "(B) such sums as are necessary for each of the five succeeding fiscal years. "(2) AVAILABILITY.— Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.". SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS THAT HAVE MARKET EXCLUSIVITY. Section 505A(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended by adding at the end the following: "(4) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS THAT HAVE MARKET EXCLUSIVITY. —

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