2025-18217: 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
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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.
The agency’s own summary, as published.
The rule, in full
338 words as published, September 19, 2025. View the original →
Federal Register, Volume 90 Issue 180 (Friday, September 19, 2025) [Federal Register Volume 90, Number 180 (Friday, September 19, 2025)] [Rules and Regulations] [Page 45134] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-18217] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2025-N-0002] 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
Agency
Food and Drug Administration, HHS.
Action
Final rule; correction. -----------------------------------------------------------------------
Summary
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.
Dates
This rule is effective September 19, 2025.
For Further Information Contact
Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-402-5693, [email protected].
Supplementary Information
In the Federal Register document 2025-16079 published on August 22, 2025 (90 FR 40966), the amendatory language in instruction 24 directing revisions in paragraph (e)(1)(vii) was an error. On page 40971, the table under Sec. 558.68 Avilamycin, contained an extra row with information that was not part of this drug application. This document corrects these errors. Correction In FR Doc. 2025-16079, published August 22, 2025, at 90 FR 40966, make the following correction: 0
1. On page 40971, in the third column, correct instruction 24 to read
as follows: ``24. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows:'' Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-18217 Filed 9-18-25; 8:45 am] BILLING CODE 4164-01-P
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
Documents
- Full text (Federal Register) · September 19, 2025
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