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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter September/October 2000 Volume XV, No. V

FDA's Center for Veterinary Medicine (CVM) published a final rule to reclassify sheep as a minor species for all data collection purposes in the August 3, 2000, Federal Register. This reclassification allows sponsors of new animal drug applications to extrapolate human food safety data from a major species such as cattle to sheep. In particular this rule will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

A copy of this final rule may be obtained from CVM's Home Page on the Internet or by calling or writing the FDA Veterinarian.

In the Federal Register of July 26, 1999, FDA published a proposed rule to revise the definition of minor species in Title 21, Part 514.1 of the Code of Federal Regulations by deleting the following language: "Sheep are a minor species with respect to effectiveness and animal safety data collection requirements; sheep are a major species with respect to human safety data collection requirements arising from the possible presence of drug residues in food." This change makes sheep a minor species for all data collection purposes.

The benefit of this final rule will be to lessen the pre-approval study requirements of New Animal Drug Approvals (NADAs) for animal drugs to be used in sheep. It is expected to lower research expenses and provide an impetus for drug sponsors to submit NADAs for minor use species rather than rely on extra-label use of animal drugs on sheep. The rule went into effect on September 5, 2000.

Further information about this final rule may be obtained from Dr. Meg Oeller, Center For Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7581