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HHS/FDA RIN: 0910-AH27 Publication ID: Fall 2016 
Title: Labeling Requirement 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 (Rx) new animal products, new animal drug products for use in feed, and over-the-counter (OTC) new animal drug products. The objective of the proposed rule is to protect the health of animals by providing more drug information in a more uniform format on the animal drug label. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about 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 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 201    21 CFR 500    21 CFR 501    21 CFR 510    21 CFR 514   
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  06/00/2017 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
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
MPN-2, Room E448, HFV-126, 7500 Standish Place,
Rockville, MD 20855
Phone:240 402-0814
Email: suzanne.sechen@fda.hhs.gov