FDA Proposes to Define Minor Use

March 21, 2008 - The Food and Drug Administration's Center for Veterinary Medicine (FDA/CVM) issued its proposed rule this week defining the meaning of "small numbers" as it relates to major species in the provisions of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act). The seven major species included in this proposal are cattle, horses, swine, chickens, turkeys, dogs and cats.

The MUMS act provides incentives for the development of new animal drugs for use in minor animal species and for minor uses in major animal species. Minor use is defined as the intended use of a drug in a major species for a disease or condition that occurs infrequently and in only a small number of animals annually or in limited geographical areas.

To stimulate animal drug development for minor uses in major species and at the same time to prevent wider use of such new animal drugs, FDACVM is proposing to define the term "small number of animals" for each of the major species that would provide the upper limit of a minor use under the MUMS act.

A complete description of the analysis for this determination can be read in the Federal Register at http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/E8-5385.htm.

Comments received on or before July 16, 2008, will be considered.

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