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HHS/FDA RIN: 0910-AG45 Publication ID: Fall 2011 
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 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 360b) to require that the sponsor of each new animal drug product that contains an antimicrobial agent 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 information on any distributor-labeled product. This rulemaking is intended to establish the implementing regulations for this statutory provision. In addition, FDA is exploring the establishment of other requirements to provide for the collection of more useful 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: Prerule 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  03/00/2012    
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