Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 516 [Docket No. FDA-2022-N-1128] RIN 0910-AI46 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to revise the “small number of animals” definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relies on the phrase “small number of animals” to characterize such use. We are proposing certain revisions to the definition of “small number of animals” based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019. DATES: Either electronic or written comments on this proposed rule or its companion direct final rule must be submitted by November 14, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 14, 2022. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, the Agency will publish a document withdrawing th…