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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues a Notice of Proposed Rule Making Defining Small Number of Animals for Minor Use Designation

March 18, 2008

The Food and Drug Administration (FDA) is issuing a notice of proposed rule making today to amend the implementing regulations of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).

The designation provision of the 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. The MUMS act includes a definition for the term "minor use" that relies on the phrase "small number of animals" to characterize such use. In response to Congress’ charge to the agency to further define minor use this amendment proposes a definition for the term "small number of animals" which includes a specific threshold 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.

The seven major species are cattle, horses, swine, chickens, turkeys, dogs, and cats.

Additional information about the proposed rule is included in the March 18, 2008, Federal Register. Additional information about the proposed rule is included in the March 18, 2008, Federal Register, which can be found at the following link http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5385.htm.

Written or electronic comments to this proposed rule may be submitted for the next 120 days.

For additional information on animal drugs for minor uses and minor species, please see http://www.fda.gov/cvm/minortoc.htm.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855