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HHS/FDA RIN: 0910-AG44 Publication ID: Spring 2011 
Title: Antimicrobial Active Ingredient Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 
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 U.S.C. 360b) to require that the sponsor of each new animal drug 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 that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. FDA recognizes the need for standardized reporting; thus, this direct final rule, with its companion proposal, is to mandate the use of an FDA form. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
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
Withdrawn  05/10/2011    
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:
Lee D. Korb
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Veterinary Medicine, 7519 Standish Place, Room 164, MPN-4, HFV-200,
Rockville, MD 20855
Phone:240 276-9258
Fax:240 276-7692
Email: lee.korb@fda.hhs.gov