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HHS/FDA RIN: 0910-AG45 Publication ID: Spring 2013 
Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals 
Abstract: Section 105 of the Animal Drug User Fee Amendments of 2008 amended the Federal Food, Drug, and Cosmetic Act to require that the sponsor of each antimicrobial new animal drug product submit an annual report to the Food and Drug Administration 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: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
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  04/00/2014 
Regulatory Flexibility Analysis Required: Undetermined  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:
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