Page:United States Statutes at Large Volume 121.djvu/900

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[121 STAT. 879]
[121 STAT. 879]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 879

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holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies. ‘‘(B) SINGLE WRITTEN REQUEST.—A single written request— ‘‘(i) may relate to more than one use of a drug; and ‘‘(ii) may include uses that are both approved and unapproved. ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— ‘‘(A) REQUEST AND RESPONSE.— ‘‘(i) IN GENERAL.—If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the applicant or holder to act on the request by— ‘‘(I) indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the request; or ‘‘(II) indicating that the applicant or holder does not agree to the request and stating the reasons for declining the request. ‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed. ‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder that, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, agrees to the request for such studies shall provide the Secretary, at the same time as the submission of the reports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such reports. ‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.

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