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HHS/FDA RIN: 0910-AI89 Publication ID: Spring 2025 
Title: Pediatric Study Plan Requirements for New Drug and Biologics License Applications 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 14192 Designation: Regulatory 
CFR Citation: 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   
Legal Authority: 21 U.S.C. 355c(e)(7)    21 U.S.C. 355c(k)(1)    21 U.S.C. 371(a)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  See 21 U.S.C. 355c(e)(7).  07/09/2013 

Overall Description of Deadline: 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."

Timetable:
Action Date FR Cite
NPRM  02/00/2026 
Regulatory Flexibility Analysis Required: YES  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Reena Raman
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO Bldg. 51, Room 6284, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-7577
Fax:301 847-8440
Email: reena.raman@fda.hhs.gov