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HHS/FDA RIN: 0910-AG17 Publication ID: Spring 2018 
Title: New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food 

This rule would 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, this rule would 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: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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
Action Date FR Cite
NPRM  12/05/2012  77 FR 72254   
NPRM Comment Period End  03/05/2013 
Supplemental NPRM  10/28/2016  81 FR 74962   
Comment Period End  12/27/2016 
Final Action  12/00/2018 
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
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