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HHS/FDA RIN: 0910-AG45 Publication ID: Spring 2014 
Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals 
Abstract: This proposed rule would require that the sponsor of each antimicrobial new animal drug product submit an annual report to FDA on the amount of each approved or conditionally approved 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 514.80   
Legal Authority: 21 USC 360b(l)(3)   
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  11/26/2012  77 FR 59156   
NPRM  09/00/2014 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Sharon Benz
Supervisory Animal Scientist
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7519 Standish Place,
Rockville, MD 20855
Phone:240 402-5939
Email: sharon.benz@fda.hhs.gov