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HHS/FDA RIN: 0910-AI43 Publication ID: Fall 2019 
Title: ●Labeling Requirements for Approved and Conditionally Approved New Animal Drugs 
Abstract:

FDA is proposing updated regulations for the labeling of new animal drugs and new regulations that specify the format and content of labeling for prescription new animal products, new animal drug products for use in feed, and over-the-counter new animal drug products. The objective of the proposed rule is to protect the health of animals by providing pet owners and animal health professionals information in a more complete and uniform format on approved and conditionally approved new animal drug labels.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 201    21 CFR 500    21 CFR 501    21 CFR 510    21 CFR 514    ...     (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. 306b    21 U.S.C. 360ccc    21 U.S.C. 371    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2020 
Regulatory Flexibility Analysis Required: Undetermined  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, Room E448, HFV-126,
Rockville, MD 20855
Phone:240 402-0814
Email: suzanne.sechen@fda.hhs.gov