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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.