Regulatory Brief

 Defining small number of animals for minor use designation


Formal title: Docket Number [2008N-011] Defining Small Number of Animals for Minor Use Designation

The FDA has issued a notice of proposed rule making defining small number of animals of "major species" (cattle, horses, swine, chickens, turkeys, dogs and cats) for minor use designation.

Brief Description:

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, FDA is proposing to amend the implementing regulations of the MUMS act. In response to Congress' charge to the agency to further define minor use, this amendment proposes 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. The deadline for written or electronic comments on the proposed rule was July 16, 2008.

AVMA Response:

The AVMA comments noted that AVMA appreciates CVM's attempt, for regulatory purposes, to use a quantitative, approach to define a "small number of animals" for each of the seven major animal species, to determine whether the use of any particular product meets the intention of Congress in considering the "minor use" of any drug for the treatment of a disease or condition in a major species. The AVMA fully understands that, for a variety of reasons, that this is a challenging undertaking.

The AVMA suggested that the FDA might postpone adopting the proposed methods of quantitatively determining "minor uses" until these have been tested in one or more real (not theoretical) scenarios. If the FDA does adopt a quantitative approach at this point in time the AVMA strongly suggested that the agency review this approach on a regular basis – at least every five years or less – to determine if the approach is viable. Furthermore, the FDA must be prepared to modify the regulations as necessary should the approach not fully meet Congress' intent for making drugs for minor conditions and diseases in all major species available for use.

Background Documents:

View AVMA's response to FDA (PDF)

View FDA Proposed Rule (PDF)

Status:

AVMA responded on July 15, 2008