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HHS/FDA RIN: 0910-AG17 Publication ID: Fall 2016 
Title: New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food 
Abstract: FDA is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved applications for conditional approval of new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, the Agency is proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 556   
Legal Authority: 21 U.S.C. 342    21 U.S.C. 360b    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/05/2012  77 FR 72254   
NPRM Comment Period End  03/05/2013 
Supplemental NPRM  03/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dong Yan
Biologist
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, MPN-2, HFV-151, 7500 Standish Place,
Rockville, MD 20855
Phone:240 402-0825
Email: dong.yan@fda.hhs.gov