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The FDA is proposing to amend its animal drug regulations in 21 CFR part 516 to change the small numbers standard for certain species. The Minor Use and Minor Species Animal Health Act of 2004 provided incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. The Act provided a statutory definition of minor use that relied on the phrase small number of animals to characterize such use. In 2009, FDA defined small number for each of the seven major animal species (cattle, swine, horses, turkeys, chickens, dogs, and cats). FDA periodically reassesses the small numbers to ensure their accuracy. After completion of the most recent reassessment, FDA is proposing to change the small number for certain species.