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HHS/FDA RIN: 0910-AG93 Publication ID: Spring 2013 
Title: ●Pediatric Study Plan Requirements for New Drug and Biologics License Applications 
Abstract: FDA is proposing regulations to establish requirements for pediatric study plans. The proposed rule would implement section 506 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is designed to facilitate pediatric product development. The proposed rule would require the submission of pediatric study plans earlier in the drug development process than currently occurs in many cases. FDA is also proposing requirements for the content of initial pediatric study plans, a process for reaching agreement with FDA on initial plans, and a process for amending pediatric study plans. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CRF 314.56; 21 CFR 314.101; 21 CFR 601.23; 21 CFR 312.42 
Legal Authority: 21 USC 355B 
Legal Deadline:
Action Source Description Date
Final  Statutory  Pediatric Study Plans section 506 (title V) FDASIA  07/09/2013 

Overall Description of Deadline: Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013.

Timetable:
Action Date FR Cite
NPRM  07/00/2013   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Jane Inglese
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6210, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3229
Fax:301 847-8752
Email: jane.inglese@fda.hhs.gov

 
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