0910-AG93 201404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Pediatric Study Plan Requirements for New Drug and Biologics License Applications Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 314.56 21 CFR 314.101 21 CFR 601.23 21 CFR 312.42 21 USC 355B Statutory Final 07/09/2013 Pediatric Study Plans section 506 (title V) FDASIA Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013. No NPRM 09/00/2014 No None No No No No Martha Nguyen 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 martha.nguyen@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 6250, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002