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HHS/FDA RIN: 0910-AI43 Publication ID: Fall 2023 
Title: Labeling Requirements for Approved and Conditionally Approved New Animal Drugs 

FDA is proposing to update existing requirements and establish 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 proposed 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 and conditionally approved new animal drugs.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 500    21 CFR 501    21 CFR 510    21 CFR 514    21 CFR 516    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 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)    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Suzanne Sechen
Supervisory Animal Scientist
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-137,
Rockville, MD 20855
Phone:240 402-0814