0910-AG03 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Defining the Term "Small Numbers of Animals" for Minor Use Designation The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (21 U.S.C. 360ccc2, 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. Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 516 21 USC 360ccc2 21 USC 371 No NPRM 05/00/2008 NPRM Comment Period End 08/00/2008 No None No Not Collected Margaret Oeller 0910 Food and Drug Administration FDA 240 276-9005 240 276-9001 margaret.oeller@fda.hhs.gov HFV-2, Center for Veterinary Medicine, Room 150 (MPN-4, HFV-50), 7500 Standish Place, Rockville MD 20855