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HHS/FDA RIN: 0910-AG03 Publication ID: Fall 2008 
Title: Defining the Term "Small Numbers of Animals" for Minor Use Designation  
Abstract: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (21 USC 360ccc-1, 360ccc-2, 371) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relied on the phrase “small numbers of animals” to characterize such use. At this time, FDA is proposing to amend 21 CFR part 516 (the implementing regulations of the MUMS act) to further define “minor use” by defining a specific “small number of animals” for each of the seven major animal species, to be used in determining whether any particular intended use in a major species is a minor use. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 516   
Legal Authority: 21 USC 360ccc-1    21 USC 360ccc-2    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/18/2008  73 FR 14411   
NPRM Comment Period End  07/16/2008    
Final Action  07/00/2009    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Margaret Oeller
Director, Office of Minor Use and Minor Species Animal Drug Development
Department of Health and Human Services
Food and Drug Administration
HFV-2, Center for Veterinary Medicine, Room N375, MPN-2, HFV-50, 7500 Standish Place,
Rockville, MD 20855
Phone:240 402-0566
Email: margaret.oeller@fda.hhs.gov