Page:United States Statutes at Large Volume 115 Part 2.djvu/436

 115 STAT. 1420 PUBLIC LAW 107-109-^AN. 4, 2002 the scientific and ethical consideration of topics of pediatric cancer, as necessary: (i) At least two pediatric oncology specialists from the National Cancer Institute. (ii) At least four pediatric oncology specialists from— (I) the Children's Oncology Group; (II) other pediatric experts with an established history of conducting clinical trials in children; or (III) consortia sponsored by the National Cancer Institute, such as the Pediatric Brain Tumor Consortium, the New Approaches to Neuroblastoma Therapy or other pediatric oncology consortia. (iii) At least two representatives of the pediatric cancer patient and patient-family community. (iv) One representative of the nursing community. (v) At least one statistician. (vi) At least one representative of the pharmaceutical industry. (b) PRE-CLINICAL MODELS TO EVALUATE PROMISING PEDIATRIC CANCER THERAPIES.—Section 413 of the Public Health Service Act (42 U.S.C. 285a-2) is amended by adding at the end the following: " (c) PRE-CLINICAL MODELS TO EVALUATE PROMISING PEDL\TRIC CANCER THERAPIES. — "(1) EXPANSION AND COORDINATION OF ACTIVITIES.— The Director of the National Cancer Institute shall expand, intensify, and coordinate the activities of the Institute with respect to research on the development of preclinical models to evaluate which therapies are likely to be effective for treating pediatric cancer. " (2) COORDINATION WITH OTHER INSTITUTES. — The Director of the Institute shall coordinate the activities under paragraph (1) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that those Institutes and agencies have responsibilities that are related to pediatric cancer.". (c) CLARIFICATION OF AVAILABILITY OF INVESTIGATIONAL NEW DRUGS FOR PEDIATRIC STUDY AND USE. — (1) AMENDMENT OF THE FEDERAL FOOD, DRUG, AND COS- METIC ACT. — Section 505(i)(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(l)) is amended— (A) in subparagraph (B), by striking "and" at the end; (B) in subparagraph (C), by striking the period at the end and inserting "; and"; and (C) by adding at the end the following: "(D) the submission to the Secretary by the manufacturer or the sponsor of the investigation of a new drug of a statement of intent regarding whether the manufacturer or sponsor has plans for assessing pediatric safety and efficacy.". (2) AMENDMENT OF THE PUBLIC HEALTH SERVICE ACT. — Section 402(j)(3)(A) of the Public Health Service Act (42 U.S.C. 282(j)(3)(A)) is amended in the first sentence— (A) by striking "trial sites, and" and inserting "trial sites,"; and

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