Page:United States Statutes at Large Volume 115 Part 2.djvu/429

 PUBLIC LAW 107-109^JAN. 4, 2002 115 STAT. 1413 SEC. 5. TIMELY LABELING CHANGES FOR DRUGS GRANTED EXCLU- SIVITY; DRUG FEES. (a) ELIMINATION OF USER FEE WAIVER FOR PEDIATRIC SUPPLE- MENTS. —Section 736(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(l)) is amended— (1) by striking subparagraph (F); and (2) by redesignating subparagraph (G) as subparagraph (F). (b) LABELING CHANGES. — (1) DEFINITION OF PRIORITY SUPPLEMENT. —Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: "(kk) PRIORITY SUPPLEMENT. —The term 'priority supplement' means a drug application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 (111 Stat. 2298).". (2) TREATMENT AS PRIORITY SUPPLEMENTS. —Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by adding at the end the following: " (1) LABELING SUPPLEMENTS. — " (1) PRIORITY STATUS FOR PEDIATRIC SUPPLEMENTS. —-Any supplement to an application under section 505 proposing a labeling change pursuant to a report on a pediatric study under this section— "(A) shall be considered to be a priority supplement; and "(B) shall be subject to the performance goals established by the Commissioner for priority drugs. " (2) DISPUTE RESOLUTION. — " (A) REQUEST FOR LABELING CHANGE AND FAILURE TO AGREE.— If the Commissioner determines that an application with respect to which a pediatric study is conducted under this section is approvable and that the only open issue for final action on the application is the reaching of an agreement between the sponsor of the application and the Commissioner on appropriate changes to the labeling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application— "(i) the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and "(ii) if the sponsor of the application does not agree to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee. " (B) ACTION BY THE PEDIATRIC ADVISORY SUB- COMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY COM- MITTEE. — Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee shall— "(i) review the pediatric study reports; and "(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any. Deadline. Deadline.

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