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HHS/FDA RIN: 0910-AI65 Publication ID: Fall 2021 
Title: ●Revocation of Methods of Analysis Regulation 
Abstract:

The proposed 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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 2.19   
Legal Authority: FD&C Act    15 U.S.C. 402    15 U.S.C. 409    21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 335    21 U.S.C. 342 and 343    21 U.S.C. 3346a    21 U.S.C. 348    21 U.S.C. 351 and 352    21 U.S.C. 355    21 U.S.C. 360b    21 U.S.C. 361 and 362    21 U.S.C. 371 and 372    21 U.S.C. 374    42 U.S.C. 7671 et seq.   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Nadine Dominique
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
12420 Parklawn Drive,
Rockville, MD 20852
Phone:301 348-1868
Email: nadine.dominique@fda.hhs.gov