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HHS/FDA RIN: 0910-AI18 Publication ID: Fall 2021 
Title: Conditional Approval of New Animal Drugs for Minor Use and Minor Species 
Abstract:

FDA is issuing procedural regulations for conditional approval of new animal drugs for minor use and minor species under the conditional approval provisions of the Federal Food, Drug, and Cosmetic Act. The new regulations are intended to make more medications for minor use and minor species legally available to veterinarians and animal owners. Conditional approval allows the sponsor to market the drug after demonstrating the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness but before collecting all necessary effectiveness data for full approval. The drug sponsor can keep the product on the market for up to 5 years, through annual renewals, while collecting all necessary effectiveness data required for full approval.

 
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 516   
Legal Authority: 21 U.S.C. 360ccc    21 U.S.C. 371(a)    21 U.S.C. 321   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    02/02/2007 
Final  Statutory    02/02/2008 
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, Room 390, HFV-100,
Rockville, MD 20855
Phone:240 402-0689
Email: urvi.desai@fda.hhs.gov