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HHS/FDA RIN: 0910-AG45 Publication ID: Fall 2016 
Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals 
Abstract:

This final rule will require that the sponsor of each approved or conditionally approved antimicrobial new animal drug product submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 514.80   
Legal Authority: 21 U.S.C. 360b(l)    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  07/27/2012  77 FR 44177   
ANPRM Comment Period End  09/25/2012 
ANPRM Comment Period Extended  09/26/2012  77 FR 59156   
ANPRM Comment Period Extended End  11/26/2012 
Final Rule  05/11/2016  81 FR 29129   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Sujaya Dessai
Supervisory Veterinary Medical Officer
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, Room 2620, HFV–212, 7519 Standish Place,
Rockville, MD 20855
Phone:240 402-5761
Email: sujaya.dessai@fda.hhs.gov