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HHS/FDA RIN: 0910-AG46 Publication ID: Fall 2016 
Title: Abbreviated New Animal Drug Applications and Phased Review Process for New Animal Drug Applications 

The Generic Animal Drug and Patent Restoration Act (GADPTRA) authorized abbreviated applications for the approval of a new animal drug. This rulemaking is intended to establish the 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 514   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 356a    21 U.S.C. 360b    21 U.S.C. 371    21 U.S.C. 379e    21 U.S.C. 381   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    11/16/1989 
Action Date FR Cite
NPRM  06/00/2017 
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