Page:United States Statutes at Large Volume 115 Part 2.djvu/435

 PUBLIC LAW 107-109-^AN. 4, 2002 115 STAT. 1419 (7) in paragraphs (1) and (2) of subsection (j) (as so redesignated), by striking "(including those developed under subsection (d)(2)(B)(i)(II))" each place it appears. SEC. 14. PEDIATRIC PHARMACOLOGY ADVISORY COMMITTEE. 42 USC 284m (a) IN GENERAL.— The Secretary of Health and Human Services shall, under section 222 of the Public Health Service Act (42 U.S.C. 217a), convene and consult an advisory committee on pediatric pharmacology (referred to in this section as the "advisory committee"). (b) PURPOSE.— (1) IN GENERAL,—The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs and in consultation with the Director of the National Institutes of Health, on matters relating to pediatric pharmacology. (2) MATTERS INCLUDED.— The matters referred to in paragraph (1) include— (A) pediatric research conducted under sections 351, 4091, and 499 of the Public Health Service Act and sections 501, 502, 505, and 505A of the Federal Food, Drug, and Cosmetic Act; (B) identification of research priorities related to pediatric pharmacology and the need for additional treatments of specific pediatric diseases or conditions; and (C) the ethics, design, and analysis of clinical trials related to pediatric pharmacology. (c) COMPOSITION. —The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary. SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE. (a) CLARIFICATION OF AUTHORITIES.— (1) IN GENERAL. —The Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (referred to in this section as the "Subcommittee"), in carrying out the mission of reviewing and evaluating the data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pediatric cancers, shall— (A) evaluate and, to the extent practicable, prioritize new and emerging therapeutic alternatives available to treat pediatric cancer; (B) provide recommendations and guidance to help ensure that children with cancer have timely access to the most promising new cancer therapies; and (C) advise on ways to improve consistency in the availability of new therapeutic agents. (2) MEMBERSHIP.— (A) IN GENERAL.—The Secretary shall appoint not more than 11 voting members to the Pediatric Subcommittee from the membership of the Pediatric Pharmacology Advisory Committee and the Oncologic Drugs Advisory Committee. (B) REQUEST FOR PARTICIPATION. —The Subcommittee shall request participation of the following members in

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