121 STAT. 872
Recommendations.
Public information. Web site.
dkrause on GSDDPC44 with PUBLAW
Deadline.
VerDate Aug 31 2005
08:41 Jul 13, 2009
Jkt 059194
PUBLIC LAW 110–85—SEPT. 27, 2007 analysis of the quality and consistency of pediatric information in pediatric assessments and the appropriateness of waivers and deferrals granted. Based on such review, the Secretary shall issue recommendations to the review divisions for improvements and initiate guidance to industry related to the scope of pediatric studies required under this section. ‘‘(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.— The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration— ‘‘(A) the number of assessments conducted under this section; ‘‘(B) the specific drugs and biological products and their uses assessed under this section; ‘‘(C) the types of assessments conducted under this section, including trial design, the number of pediatric patients studied, and the number of centers and countries involved; ‘‘(D) the total number of deferrals requested and granted under this section and, if granted, the reasons for such deferrals, the timeline for completion, and the number completed and pending by the specified date, as outlined in subsection (a)(3); ‘‘(E) the number of waivers requested and granted under this section and, if granted, the reasons for the waivers; ‘‘(F) the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons any such formulation was not developed; ‘‘(G) the labeling changes made as a result of assessments conducted under this section; ‘‘(H) an annual summary of labeling changes made as a result of assessments conducted under this section for distribution pursuant to subsection (h)(2); ‘‘(I) an annual summary of information submitted pursuant to subsection (a)(3)(B); and ‘‘(J) the number of times the committee referred to in paragraph (1) made a recommendation to the Secretary under paragraph (4) regarding priority review, the number of times the Secretary followed or did not follow such a recommendation, and, if not followed, the reasons why such a recommendation was not followed. ‘‘(g) LABELING CHANGES.— ‘‘(1) DISPUTE RESOLUTION.— ‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO AGREE.—If, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, the Commissioner determines that a sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application or supplement, not later than 180 days after the date of the submission of the application or supplement— ‘‘(i) the Commissioner shall request that the sponsor of the application make any labeling change
PO 00001
Frm 00050
Fmt 6580
Sfmt 6581
O:\FROMSTAT\PUBL085.121
APPS10
PsN: PUBL085
�
