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HHS/FDA RIN: 0910-AG93 Publication ID: Spring 2018 
Title: Pediatric Study Plan Requirements for New Drug and Biologics License Applications 

FDA is proposing requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients; a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products. Developing drugs for pediatric populations presents unique challenges for drug manufacturers. Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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  04/00/2019 
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