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HHS/FDA RIN: 0910-AI54 Publication ID: Fall 2020 
Title: ●Abbreviated New Animal Drug Applications 
Abstract:

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: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 514    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 360b    21 U.S.C. 371   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    11/16/1989 
Timetable:
Action Date FR Cite
NPRM  08/00/2021 
Regulatory Flexibility Analysis Required: No  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:
Urvi Desai
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7500 Standish Place, MPN-2, Room 390, HFV-100,
Rockville, MD 20855
Phone:240 402-0689
Email: urvi.desai@fda.hhs.gov