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HHS/FDA | RIN: 0910-AH37 | Publication ID: Fall 2016 |
Title: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health | |
Abstract:
FDA is proposing to implement regulations governing internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is taking this action to codify the procedures and timeframes that apply to supervisory review of significant decisions pertaining to devices. The FDA is also proposing regulations to provide procedures and a timeframe for requesting internal agency supervisory review of other types of decisions made by CDRH not addressed in the FDASIA requirements. |
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Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 10.75 21 CFR 800.75 | |
Legal Authority: 5 U.S.C. 551 to 558 5 U.S.C. 701 to 706 15 U.S.C. 1451 to 161 21 U.S.C. 141 to 149 21 U.S.C. 321 to 397 21 U.S.C. 467(f) 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 1034 28 U.S.C. 2112 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 263(b) 42 U.S.C. 264 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Undetermined |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Karen Fikes Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring, MD 20993 Phone:240 402-7911 Email: karen.fikes@fda.hhs.gov |