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
Abstract
The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors.
Federal Register Source
This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.
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Other Rules from HHS
Frequently Asked Questions
What is the 2026-11104 Federal Register document?
Document 2026-11104 is a Final Rule published by the Department of Health and Human Services in the Federal Register on June 3, 2026, with an effective date of June 3, 2026. The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors. View the original at https://www.federalregister.gov/documents/2026/06/03/2026-11104/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug.
Is document 2026-11104 an economically significant rule?
No. Document 2026-11104 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.