Page:United States Statutes at Large Volume 115 Part 2.djvu/428

 115 STAT. 1412 Deadline. PUBLIC LAW 107-109-^AN. 4, 2002 "(A) REQUEST AND RESPONSE.—I f the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (c) to the holder of an application approved under section 505(b)(1), the holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the holder to act on the request by— "(i) indicating when the pediatric studies will be initiated, if the holder agrees to the request; or "(ii) indicating that the holder does not agree to the request. "(B) No AGREEMENT TO REQUEST.— "(i) REFERRAL.— If the holder does not agree to a written request within the time period specified in subparagraph (A), and if the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall refer the drug to the Foundation for the National Institutes of Health established under section 499 of the Public Health Service Act (42 U.S.C. 290b) (referred to in this paragraph as the 'Foundation') for the conduct of the pediatric studies described in the written request. "(ii) PUBLIC NOTICE.—The Secretary shall give public notice of the name of the drug, the name of the manufacturer, and the indications to be studied made in a referral under clause (i). "(C) LACK OF FUNDS.— On referral of a drug under subparagraph (B)(i), the Foundation shall issue a proposal to award a grant to conduct the requested studies unless the Foundation certifies to the Secretary, within a timeframe that the Secretary determines is appropriate through guidance, that the Foundation does not have funds available under section 499(j)(9)(B)(i) to conduct the requested studies. If the Foundation so certifies, the Secretary shall refer the drug for inclusion on the list established under section 4091 of the Public Health Service Act for the conduct of the studies. "(D) EFFECT OF SUBSECTION.— Nothing in this subsection (including with respect to referrals from the Secretary to the Foundation) alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. "(E) No REQUIREMENT TO REFER.— Nothing in this subsection shall be construed to require that every declined written request shall be referred to the Foundation. " (F) WRITTEN REQUESTS UNDER SUBSECTION (b). —For drugs under subsection (b) for which written requests have not been accepted, if the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall issue a written request under subsection (c) cifter the date of approval of the drug.".

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