Page:United States Statutes at Large Volume 115 Part 2.djvu/430

 115 STAT. 1414 PUBLIC LAW 107-109—JAN. 4, 2002 Deadline. "(C) CONSIDERATION OF RECOMMENDATIONS. —The Commissioner shall consider the recommendations of the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application to make any labeling change that the Commissioner determines to be appropriate. "(D) MISBRANDING.— If the sponsor of the application, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application to be misbranded. "(E) No EFFECT ON AUTHORITY. — Nothing in this subsection limits the authority of the United States to bring an enforcement action under this 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.". 21 USC 393a. SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS. (a) ESTABLISHMENT.— The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration. (b) DUTIES.—The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues. (c) STAFF. —The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include— (1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population; and (2) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b). SEC. 7. NEONATES. Section 505A(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(g)) is amended by inserting "(including neonates in appropriate cases)" after "pediatric age groups". SEC. 8. SUNSET. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by striking subsection (j) and inserting the following: "(j) SUNSET. —^A drug may not receive any 6-month period under subsection (a) or (c) unless— "(1) on or before October 1, 2007, the Secretary makes a written request for pediatric studies of the drug;

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