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HHS/FDA RIN: 0910-AG93 Publication ID: Fall 2016 
Title: Pediatric Study Plan Requirements for New Drug and Biologics License Applications 

FDA is 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 314.56    21 CFR 314.101    21 CFR 601.23    21 CFR 312.42   
Legal Authority: 21 U.S.C. 355c   
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.

Action Date FR Cite
NPRM  12/00/2017 
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:
Kristiana Brugger
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6262, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2897
Fax:301 847-8437