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HHS/FDA RIN: 0910-AG46 Publication ID: Spring 2011 
Title: Abbreviated New Animal Drug Regulation 
Abstract: The Generic Animal Drug and Patent Restoration Act (GADPTRA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b) to authorize abbreviated applications for the approval of a new animal drug. This rulemaking is intended to establish the implementing regulations for GADPTRA by proposing procedural requirements for the submission and approval of generic new animal drug applications. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 514   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 356a    21 USC 360b    21 USC 371    21 USC 379e    21 USC 381   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    11/16/1989 
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
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:
John K. Harshman
Director, Division of Generic Animal Drugs
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7500 Standish Place, MPN2, HFV-170,
Rockville, MD 20855
Phone:240 402-0845
Email: john.harshman@fda.hhs.gov