121 STAT. 888
Federal Register, publication. Web site.
Deadline.
Deadline.
Recommendations. Deadline.
dkrause on GSDDPC44 with PUBLAW
Deadline.
VerDate Aug 31 2005
08:41 Jul 13, 2009
Jkt 059194
PUBLIC LAW 110–85—SEPT. 27, 2007 docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs. ‘‘(C) ACTION BY COMMISSIONER.—The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7). ‘‘(7) REQUESTS FOR LABELING CHANGE.—During the 180day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall— ‘‘(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied; ‘‘(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and ‘‘(C)(i) place in the public docket file a copy of the report and of any requested labeling changes; and ‘‘(ii) publish in the Federal Register and through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes. ‘‘(8) DISPUTE RESOLUTION.— ‘‘(A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.— If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee. ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall— ‘‘(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and ‘‘(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any. ‘‘(9) FDA DETERMINATION.—Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate. ‘‘(10) FAILURE TO AGREE.—If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of
PO 00001
Frm 00066
Fmt 6580
Sfmt 6581
O:\FROMSTAT\PUBL085.121
APPS10
PsN: PUBL085
�
