0910-AI43 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

FDA is finalizing updates to existing requirements and establishing new requirements for the format and content of labeling for prescription new animal drugs, over-the-counter new animal drugs, and new animal drugs for use in animal feed. The objective of the rule is to protect the health of animals by providing animal owners and animal health professionals information in a more complete and uniform format on the labeling of approved or conditionally approved new animal drugs.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Not subject to, not significant 21 CFR 201 21 CFR 500 21 CFR 501 21 CFR 510 21 CFR 514 21 CFR 516 ... 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 354 21 U.S.C. 360b 21 U.S.C. 360ccc 21 U.S.C. 371(a) ... No NPRM 03/12/2024 89 FR 18262 NPRM Comment Period Extended 05/22/2024 89 FR 44944 NPRM Comment Period End 06/10/2024 NPRM Comment Period Extended End 08/09/2024 Final Rule 09/00/2025 No Businesses Undetermined Undetermined No No Suzanne Sechen Supervisory Animal Scientist 0910 Food and Drug Administration FDA 240 402-0814 suzanne.sechen@fda.hhs.gov Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-137, Rockville MD 20855