FDA is issuing a final rule to revise the animal drug regulations for tolerances for residues of approved new animal drugs. This final rule is necessary to standardize, simplify, and clarify the determination standards of tolerances and provide definitions for key terms. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.

The final rule should produce more clarity for industry members by standardizing and simplifying the determination standards and codification style regarding tolerances. Firms will incur minimal administrative costs to read and understand the rule. We estimate that the final rule will result in annualized costs of $1,000 at a 3 percent discount rate and $1,100 at a 7 percent discount rate, over 10 years.

Federal Register: 84 FR 32982, July 11, 2019

Docket: FDA-2012-N-1067