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

Document 2026-13716 is a Final Rule published by the Department of Health and Human Services in the Federal Register on July 7, 2026, with an effective date of July 7, 2026. 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 2026. The animal drug regulations are also being amended to improve their accuracy and readability. View the original at https://www.federalregister.gov/documents/2026/07/07/2026-13716/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug.

No. Document 2026-13716 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.