0910-AI92 202310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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 FDA is proposing this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 26 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 No NPRM 11/00/2023 No No Federal Local State No No No Yes Perlesta Hollingsworth Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-5874 perlesta.hollingsworth@fda.hhs.gov Bldg. 32, Rm. 4339, 10903 New Hampshire Avenue, Silver Spring MD 20993