Regulatory Counsel

0910-AI65 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revocation of Methods of Analysis Regulation

The final rule revokes 2.19 (21 CFR 2.19), which states that it is FDA policy to use the methods of analysis of the AOAC International as published in the 1980 edition of Official Methods of Analysis of the Association of Analytical Chemists for FDA enforcement programs when the method of analysis is not prescribed in a regulation. Repeal of this regulation would eliminate an unnecessary policy.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 2.19 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 335 21 U.S.C. 342 21 U.S.C. 343 21 U.S.C. 346a 21 U.S.C. 348 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 360b 21 U.S.C. 361 21 U.S.C. 362 21 U.S.C. 371 21 U.S.C. 372 21 U.S.C. 374 ... No NPRM 07/15/2022 87 FR 42398 NPRM Comment Period End 09/28/2022 Final Rule 06/00/2023 No No None No No No No Nadine Dominique Regulatory Counsel 0910 Food and Drug Administration FDA 301 348-1868 nadine.dominique@fda.hhs.gov 10903 New Hampshire Ave, Building 32, Room 4343, Silver Spring MD 20993