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HHS/FDA RIN: 0910-AG07 Publication ID: Fall 2016 
Title: Conditional Approval of New Animal Drugs for Minor Use and Minor Species 

The Minor Use and Minor Species Animal Health Act of 2004 established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. FDA has the authority to provide for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have been met. For the effectiveness component of  a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval. Sponsors then have up to five years to complete full effectiveness and achieve a complete new animal drug 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)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    02/02/2007 
Final  Statutory    02/02/2008 
Action Date FR Cite
NPRM  06/00/2017 
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
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, MPN1 Room 203 HFV-100, 7520 Standish Place,
Rockville, MD 20855
Phone:240 276-8304
Fax:240 276-8297