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HHS/FDA RIN: 0910-AI35 Publication ID: Fall 2021 
Title: Phased Review of New Animal Drug Applications, Electronic Submission, and Master Files 
Abstract:

FDA is proposing to amend its regulations to establish requirements for the phased review of new animal drug applications, the use of master files, the electronic submission of information to support those applications or files, and to clarify existing regulations governing the submission of new animal drug applications. Electronic submission of all animal drug applications and submissions is mandated by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 12    21 CFR 20    21 CFR 58    21 CFR 201    21 CFR 225    21 CFR 226    21 CFR 500    21 CFR 510    21 CFR 511    21 CFR 514    21 CFR 516    21 CFR 558   
Legal Authority: 21 U.S.C. 360b    21 U.S.C. 371    Pub. L. 115-234, sec. 301   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2022 
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