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

FDA is proposing to amend its over-the-counter (OTC) drug regulations. The proposed rule would 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). On our own initiative, we also are proposing 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: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation:  
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. fff-6    21 U.S.C. 371(a)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Final Statutory 2/26/2017  05/26/2016 
Timetable:
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: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Anuj Shah
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 6228, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2246
Email: anuj.shah@fda.hhs.gov