Page:United States Statutes at Large Volume 115 Part 2.djvu/437

 PUBLIC LAW 107-109^JAN. 4, 2002 115 STAT. 1421 (B) by striking "in the trial," and inserting "in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children,". (d) REPORT.— Not later than January 31, 2003, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and in consultation with the Director of the National Institutes of Health, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on patient access to new therapeutic agents for pediatric cancer, including access to single patient use of new therapeutic agents. SEC. 16. REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM. Not later than October 1, 2006, the Comptroller General of the United States, in consultation with the Secretary of Health and Human Services, shall submit to Congress a report that addresses the following issues, using publicly available data or data otherwise available to the Government that may be used and disclosed under applicable law: (1) The effectiveness of section 505A of the Federal Food, Drug, and Cosmetic Act and section 4091 of the Public Health Service Act (as added by this Act) in ensuring that medicines used by children are tested and properly labeled, including— (A) the number and importance of drugs for children that are being tested as a result of this legislation and the importance for children, health care providers, parents, and others of labeling changes made as a result of such testing; (B) the number and importance of drugs for children that are not being tested for their use notwithstanding the provisions of this legislation, and possible reasons for the lack of testing; and (C) the number of drugs for which testing is being done, exclusivity granted, and labeling changes required, including the date pediatric exclusivity is granted and the date labeling changes are made and which labeling changes required the use of the dispute resolution process established pursuant to the amendments made by this Act, together with a description of the outcomes of such process, including a description of the disputes and the recommendations of the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee. (2) The economic impact of section 505A of the Federal Food, Drug, and Cosmetic Act and section 4091 of the Public Health Service Act (as added by this Act), including an estimate of— (A) the costs to taxpayers in the form of higher expenditures by medicaid and other Government programs; (B) sales for each drug during the 6-month period for which exclusivity is granted, as attributable to such exclusivity; Deadline. 21 USC 355 note. 21 USC 355a note. Deadline.

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