# Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
> **Food and Drug Administration** · Direct final rule. · Published 2022-09-15 · Effective 2022-12-14 · 87 FR 56583
## Document
- **Document number:** 2022-19954
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 87 FR 56583
- **CFR reference:** 21 CFR 516
- **Publication date:** 2022-09-15
- **Effective date:** 2022-12-14
- **HHS docket:** Docket No. FDA-2022-N-1128
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is revising the "small number of animals" definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of "minor use" that relies on the phrase "small number of animals" to characterize such use. We are revising the definition of "small number of animals" based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2022/09/15/2022-19954/defining-small-number-of-animals-for-minor-use-determination-periodic-reassessment)
---
*AI Analytics · CC0 1.0*