Page:United States Statutes at Large Volume 115 Part 2.djvu/426

 115 STAT. 1410 PUBLIC LAW 107-109-^AN. 4, 2002 Drugs shall promulgate guidance to establish the process for the submission of responses to written requests under paragraph (1). "(5) CONTRACTS.—^A contract under this section may be awarded only if a proposal for the contract is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. " (6) REPORTING OF STUDIES.— "(A) IN GENERAL.—On completion of a pediatric study in accordance with a contract awarded under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study. "(B) AVAILABILITY OF REPORTS.— Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(D)) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs. "(C) ACTION BY COMMISSIONER.—The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7). " (7) REQUESTS FOR LABELING CHANGE.—During the 180- day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall— "(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied; "(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and "(C)(i) place in the public docket file a copy of the report and of any requested labeling changes; and "(ii) publish in the Federal Register a summary of the report and a copy of any requested labeling changes. " (8) DISPUTE RESOLUTION.— "(A) REFERRAL TO PEDIATRIC ADVISORY SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE.— I f, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request 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- Deadline. MITTEE.— Not later than 90 days after receiving a referral

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