PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 871
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‘‘(1) the drug or biological product that is the subject of the assessment or request may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303); but ‘‘(2) the failure to submit the assessment or request shall not be the basis for a proceeding— ‘‘(A) to withdraw approval for a drug under section 505(e); or ‘‘(B) to revoke the license for a biological product under section 351 of the Public Health Service Act. ‘‘(e) MEETINGS.—Before and during the investigational process for a new drug or biological product, the Secretary shall meet at appropriate times with the sponsor of the new drug or biological product to discuss— ‘‘(1) information that the sponsor submits on plans and timelines for pediatric studies; or ‘‘(2) any planned request by the sponsor for waiver or deferral of pediatric studies. ‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.— ‘‘(1) REVIEW.—Beginning not later than 30 days after the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall utilize the internal committee established under section 505C to provide consultation to reviewing divisions on all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required under this section and all deferral and waiver requests granted pursuant to this section. ‘‘(2) ACTIVITY BY COMMITTEE.—The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee. ‘‘(3) DOCUMENTATION OF COMMITTEE ACTION.—For each drug or biological product, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (4) or (5), which members of the committee participated in such activity. ‘‘(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.—Consultation on pediatric plans and assessments by the committee referred to in paragraph (1) pursuant to this section shall occur prior to approval of an application or supplement for which a pediatric assessment is required under this section. The committee shall review all requests for deferrals and waivers from the requirement to submit a pediatric assessment granted under this section and shall provide recommendations as needed to reviewing divisions, including with respect to whether such a supplement, when submitted, shall be considered for priority review. ‘‘(5) RETROSPECTIVE REVIEW OF PEDIATRIC ASSESSMENTS, DEFERRALS, AND WAIVERS.—Not later than 1 year after the date of the enactment of the Pediatric Research Equity Act of 2007, the committee referred to in paragraph (1) shall conduct a retrospective review and analysis of a representative sample of assessments submitted and deferrals and waivers approved under this section since the enactment of the Pediatric Research Equity Act of 2003. Such review shall include an
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