Original publisher: [Washington, D.C.: U.S. G.P.O.: Supt. of Docs., U.S. G.P.O., distributor, 2002]. OCLC Number: (OCoLC)49574888 Subject: Drugs -- Law and legislation -- United States. Excerpt: ... 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 proce-dure, 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 ) R. - Not later than January 31, 2003, the Secretary Deadline. EPORT 21 USC 355 note. 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 Representa-tives a report on patient access to new therapeutic agents for pediatric cancer, including access to single patient use of new thera-peutic agents. SEC. 16. REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM. 21 USC 355a note. Not later than October 1, 2006, the Comptroller General of Deadline. 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 409I 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 provid...