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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA PROPOSES TO RECLASSIFY SHEEP AS A MINOR SPECIES

FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

In the July 26, 1999, Federal Register, FDA's Center for Veterinary Medicine (CVM) published a proposed rule to reclassify sheep as a minor species for all data collection purposes. This proposal allows sponsors of supplemental new animal drug applications to extrapolate human food safety data from a major species such as cattle to sheep. In particular, this will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

A copy of this proposed rule may be obtained from CVM's Federal Register Notices Page or by calling or writing the FDA Veterinarian.

Since 1983, FDA has permitted some flexibility in the means to meet data requirements to support the approval of new animal drugs intended for "minor species.'' Specifically, these classifications permit data extrapolation from a major species to support the safety and effectiveness of a new animal drug for a minor species.

"Minor species" are defined by exclusion as any species other than horses, cattle, swine, dogs, cats, chickens, and turkeys. Sheep have been classified as a minor species for the purposes of target animal safety and effectiveness studies. However, they have been considered a major species for the purpose of determining the human food safety of edible products.

In a January 1983 final rule on minor species drugs, FDA said that sheep were classified as a major species for human food safety purposes because some consumers in the United States eat a large proportion of lamb and mutton in their diets. However, the Agency stated that it would be willing to reevaluate this conclusion if new data became available.

New data have become available since publication of the 1983 final rule. These data allow FDA to conclude that sheep should be a minor species with respect to all data requirements. The new data concern the similarity of drug metabolism between sheep and cattle rather than consumption levels. FDA now believes that the body of evidence concerning drug metabolism is more significant in determining the major/minor status of species than consumption data because it demonstrates the reliability of data extrapolated from a major species.

Interested persons should submit written comments on the proposed rule by October 25, 1999, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with Docket number 99N-2151.

Further information about this proposed 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, e-mail: moeller@cvm.fda.gov.