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HHS/FDA RIN: 0910-AG17 Publication ID: Fall 2010 
Title: New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food 
Abstract: FDA is proposing to revise 21 CFR 556 to reformat the listings of tolerances for residues of approved new animal drugs in food. Currently, part 556 employs a patchwork of various styles for listing tolerances that have evolved over the past 40 years as each additional animal drug has been approved. The listings in part 556 are not uniform in format, and FDA does not always provide relevant information in a clear and straightforward manner. For example, FDA provides the acceptable daily intake (ADI) and safe concentrations for some, but not all drugs; FDA lists some tolerances as being for "negligible" residues; and FDA presents some listings in a text paragraph format while others are presented in outline form. Moreover, sometimes FDA specifies "no residue," "zero tolerance," or tolerance "not required," but does not define or make distinction between these important terms. This revision will standardize, simplify, and clarify these listings 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 USC 342    21 USC 360b    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2011    
NPRM Comment Period End  06/00/2011    
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, Room E464 (MPN-2, HFV-151), 7500 Standish Place,
Rockville, MD 20855
Phone:240 276-8117
Email: dong.yan@fda.hhs.gov