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HHS/FDA RIN: 0910-AI46 Publication ID: Spring 2020 
Title: Defining Small Numbers of Animals for Minor Use Designation; Periodic Reassessment 
Abstract:

The FDA is proposing to amend its animal drug regulations in 21 CFR part 516 to change the small numbers definition for certain species. The Minor Use and Minor Species Animal Health Act of 2004 provided incentives to animal drug sponsors to encourage development and approval for drugs intended for minor species and for minor uses in major animal species. The Federal Food, Drug, and Cosmetic Act includes a statutory definition of "minor use" 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 their accuracy. After completion of the most recent reassessment, FDA is proposing to change the "small number of animals" for certain species.

 
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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 516   
Legal Authority: 21 U.S.C. 321(pp)    21 U.S.C. 360ccc-2    21 U.S.C. 371(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2021 
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 150 (MPN-4, HFV-50), 7500 Standish Place,
Rockville, MD 20855
Phone:240 402-0566
Fax:240 276-9001
Email: margaret.oeller@fda.hhs.gov