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HHS/FDA RIN: 0910-AI92 Publication ID: Fall 2023 
Title: ●Revocation of the Mutual Recognition of Pharmaceutical Good Manufacturing Practice, Medical Device Quality System Audit, and Certain Medical Device Product Evaluation Reports: U.S. and the E.C. 

FDA is proposing to revoke the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community. FDA is proposing this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 26   
Legal Authority: 5 U.S.C. 552    15 U.S.C. 1453    15 U.S.C. 1454    15 U.S.C. 1455    18 U.S.C. 1905    21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 360c    21 U.S.C. 360d    21 U.S.C. 360e    21 U.S.C. 360f    21 U.S.C. 360g    21 U.S.C. 360h    21 U.S.C. 360i    21 U.S.C. 360j    21 U.S.C. 360l    21 U.S.C. 360m    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 381 and 382    21 U.S.C. 383    21 U.S.C. 384e    21 U.S.C. 393    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 242l    42 U.S.C. 262    42 U.S.C. 264    42 U.S.C. 265   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Perlesta Hollingsworth
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Bldg. 32, Rm. 4339, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-5874