2022-19955: Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of its most recent periodic reassessment of the definition of "small number of animals" for minor use in major species (contained in our existing regulation for new animal drugs for minor use and minor species). We also are announcing that the small number of animals upper limit thresholds (small numbers) for horses and the food-producing major species (cattle, pigs, turkeys, and chickens) will remain the same. We are separately issuing a direct final rule and a companion proposed rule to revise (i.e., increase) the small numbers for dogs and cats.
The agency’s own summary, as published.
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