Senior Regulatory Counsel

0910-AI89 202504 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

FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Regulatory 21 CFR 314.56 (new) 21 CFR 314.57 (new) 21 CFR 601.23 (new) 21 CFR 601.24 (new) 21 CFR 312.42 21 CFR 312.47 21 CFR 312.82 21 CFR 314.81 21 CFR 314.101 21 CFR 201.23 21 CFR 312.23(a)(10)(iii) 21 CFR 314.50(d)(7) 21 CFR 314.55 21 CFR 601.27 21 CFR 601.28 21 U.S.C. 355c(e)(7) 21 U.S.C. 355c(k)(1) 21 U.S.C. 371(a) Statutory NPRM 07/09/2013 See 21 U.S.C. 355c(e)(7). 21 U.S.C. 355c(e)(7): "Not later than 1 year after July 9, 2012, the Secretary shall promulgate proposed regulations and issue guidance to implement the provisions of this subsection." No NPRM 02/00/2026 YES Businesses None No No Yes No Reena Raman Senior Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-7577 301 847-8440 reena.raman@fda.hhs.gov Center for Drug Evaluation and Research, WO Bldg. 51, Room 6284, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002