PUBLIC LAW 107-109^JAN. 4, 2002 115 STAT. 1409 "(iii) there is no patent protection or market exclusivity protection under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or "(iv) there is a referral for inclusion on the list under section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C)); and "(B) in the case of a drug referred to in clause (i), (ii), or (iii) of subparagraph (A), additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population. "(2) CONSIDERATION OF AVAILABLE INFORMATION.— In developing and prioritizing the list under paragraph (1), the Secretary shall consider, for each drug on the list— "(A) the availability of information concerning the safe and effective use of the drug in the pediatric population; "(B) whether additional information is needed; "(C) whether new pediatric studies concerning the drug may produce health benefits in the pediatric population; and "(D) whether reformulation of the drug is necessary. "(b) CONTRACTS FOR PEDIATRIC STUDIES. — The Secretary shall award contracts to entities that have the expertise to conduct pediatric clinical trials (including qualified universities, hospitals, laboratories, contract research organizations, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct pediatric studies concerning one or more drugs identified in the list described in subsection (a). "(c) PROCESS FOR CONTRACTS AND LABELING CHANGES.— " (1) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS LACKING EXCLUSIVITY.— The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified in the list described in subsection (a)(1)(A) (except clause (iv)) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (a) or (b) of section 505A of the Federal Food, Drug, and Cosmetic Act, including with respect to information provided on the pediatric studies to be conducted pursuant to the request. "(2) REQUESTS FOR CONTRACT PROPOSALS.— If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (1) within 30 days of the date on which a request was issued, or if a referral described in subsection (a)(l)(A)(iv) is made, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for contract proposals to conduct the pediatric studies described in the written request. "(3) DISQUALIFICATION.^A holder that receives a first right of refusal shall not be entitled to respond to a request for contract proposals under paragraph (2). "(4) GUIDANCE. —Not later than 270 days after the date of enactment of this section, the Commissioner of Food and Deadline. DeadMne.
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