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HHS/FDA RIN: 0910-AG07 Publication ID: Spring 2011 
Title: Conditional Approval of New Animal Drugs for Minor Use and Minor Species 
Abstract: This proposed rule implements section 571 of the Food, Drug, and Cosmetic Act. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) added three sections to the Federal Food, Drug, and Cosmetic Act (the Act) (571, 572, and 573), and it 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. Section 571 of the Act provides for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the Act. For the effectiveness component of a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval under section 571 of the Act. Sponsors then have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the Act 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: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 516   
Legal Authority: 21 USC 360ccc    21 USC 371(a)   
Legal Deadline:
Action Source Description Date
Final  Statutory    02/02/2008 
NPRM  Statutory    02/02/2007 
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
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
Email: urvi.desai@fda.hhs.gov