# Defining “Small Number of Animals” for Minor Use Designation
> **Food and Drug Administration** · Final rule. · Published 2009-08-26 · Effective 2009-11-09 · 74 FR 43043
## Document
- **Document number:** E9-20553
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 43043
- **CFR reference:** 21 CFR 516
- **Publication date:** 2009-08-26
- **Effective date:** 2009-11-09
- **HHS docket:** Docket No. FDA-2008-N-0176
## Abstract

The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of "minor use" that relied on the phrase "small number of animals" to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress' charge to the agency to further define minor use, this amendment establishes a specific "small number of animals" for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/08/26/E9-20553/defining-small-number-of-animals-for-minor-use-designation)
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