Department of Health and Human Services
Food and Drug Administration
- 21 CFR Part 558
- [Docket No. FDA-2025-N-0002]
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, cathie.marshall@fda.hhs.gov.