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HHS/FDA RIN: 0910-AI35 Publication ID: Spring 2019 
Title: ●Applications for New Animal Drugs, Abbreviated Applications for New Animal Drugs, and Applications for Conditional Approval of New Animal Drugs; Electronic Submission Requirements  
Abstract:

The FDA is proposing to amend its animal drug regulations to require that applications for new animal drugs, abbreviated applications for new animal drugs, and applications for conditional approval of new animal drugs be submitted to us in an electronic format. The proposed change would revise our regulations to be consistent with recent changes to the Federal Food, Drug, and Cosmetic Act added by the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).

 
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: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 511    21 CFR 514   
Legal Authority: 21 U.S.C. 360b(b)    21 U.S.C. 360ccc(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2020 
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, HFV-100,
Rockville, MD 20855
Phone:240 402-0689
Email: urvi.desai@fda.hhs.gov