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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.