New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction

Document 2025-18217 is a Final Rule published by the Food and Drug Administration in the Federal Register on September 19, 2025, with an effective date of September 19, 2025. The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error. View the original at https://www.federalregister.gov/documents/2025/09/19/2025-18217/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug.

No. Document 2025-18217 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.