Regulatory Counsel

0910-AI89 202404 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.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 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 10/00/2024 YES Businesses None No No Yes No Kristiana Brugger Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3600 kristiana.brugger@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire Avenue, Silver Spring MD 20993