[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