Back on March 8th, 2024, the US Food and Drug Administration proposed new regulations around labelling requirements for approved or conditionally approved new animal drugs for both over the counter and animal feed-related categories. The idea was to provide animal drug sponsors and others involved with the selection and administration of the drugs with predictable requirements. The output would place all the labeling requirements regarding the content and format of approved or conditionally approved new animal drugs in one location in the Code of Federal Regulations.
The FDA gave a 90-day public comment period that was due to expire on June 10th, 2024. This period has now been extended by 60 days to allow those interested more time to review and submit comments. The new deadline is August 9th, 2024.
Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to:
Dockets Management Staff (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Rm 1061,
Rockville, MD 20852
All submissions received must include the Docket No. FDA-2023-N-5160 for “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.”
