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HHS/FDA RIN: 0910-AH30 Publication ID: Fall 2016 
Title: FDA Review and Action on Over-the-Counter Time and Extent Applications 

FDA is amending its over-the-counter (OTC) drug regulations. The final rule will supplement the time and extent application (TEA) process for OTC drug products by establishing timelines and measurable metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). The final rule will also address other changes to make the TEA process more efficient.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 330   
Legal Authority: 21 U.S.C. 371(a)    21 U.S.C. 321    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360fff-6    21 U.S.C. 371   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Final Statutory 2/26/2017  05/26/2016 
Action Date FR Cite
NPRM  04/04/2016  81 FR 19069   
NPRM Comment Period End  06/03/2016 
Final Rule  02/00/2017 
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:
Anuj Shah
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 6224,
Silver Spring, MD 20993
Phone:301 796-2246