The proposed rule would revoke 21 CFR 2.19 methods of analysis, which states that FDA policy is to use the Association of Official Analytical Chemists (AOAC) methods of analysis as published in the 1980 edition of “Official Methods of Analysis of the Association of Analytical Chemists” to analyze samples in FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is proposing this action because a general reference to the 1980 edition of the “Official Methods of Analysis of the Association of Analytical Chemists” is unnecessary and because newer, updated methods of analysis may exist. FDA believes it is more appropriate, flexible, and efficient to identify the Agency’s preferred methods of analysis in documents such as the Office of Regulatory Affairs (ORA) Laboratory Procedures Manual, FDA compliance programs, and other resources. This Proposed Regulatory Impact Analysis discusses the economic impacts of the proposed rule, including potential costs, cost savings, and benefits. We expect the economic impact on the FDA resulting from revoking an unnecessary regulation to be minimal.
Regulatory Impact Analysis
Federal Register: 87 FR 42398, July 15, 2022