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HHS/FDA RIN: 0910-AI46 Publication ID: Spring 2022 
Title: Defining "Small Number of Animals" for Minor Use Determination; Periodic Reassessment 

FDA is amending its animal drug regulations in 21 CFR part 516 via Direct Final Rule to revise the definition for "small number of animals." The Minor Use and Minor Species Animal Health Act of 2004 provides incentives to animal drug sponsors to encourage the development of drugs intended for use in minor species and for minor uses in the major animal species. The Federal Food, Drug, and Cosmetic Act includes a statutory definition of "minor use" (21 U.S.C. 321(pp)) that relies on the phrase "small number of animals" to characterize such use. In 2009, FDA defined "small number of animals" for each of the seven major animal species (cattle, swine, horses, turkeys, chickens, dogs, and cats). FDA periodically reassesses the "small number of animals" definition to ensure its accuracy. After completing the most recent reassessment, FDA is changing the "small number of animals" definition to increase the small numbers for dogs and cats. This could increase the small number of uncommon conditions and diseases in dogs and cats that qualify for minor use drug development.

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: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 516   
Legal Authority: 21 U.S.C. 321(pp)    21 U.S.C. 360ccc    21 U.S.C. 360ccc-2    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
Direct Final Rule  08/00/2022 
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:
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