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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 | |
Abstract:
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. |
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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:
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Timetable:
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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 Email: anuj.shah@fda.hhs.gov |