New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor

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 Parts 510, 516, 520, 522, and 524 [Docket No. FDA-2025-N-0002] ( printed page 19623) AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective May 9, 2025. FOR FURTHER INFORMATION CONTACT: Barbara Leotta, DVM, Deputy Office Director, Office of New Animal Product Evaluation Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0605, Barbara.Leotta@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Approval of New Animal Drug Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2025, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summ…