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<OL> <LI> Identify needs for animal drugs for minor species and minor uses in major species<LI> Generate and disseminate data for the safe, effective and legal use of drugs intended for use in minor animal species<LI> Facilitate FDA/CVM approvals of drugs for minor species and minor uses </ol>Specific projects proposed for 2009 to 2011 are demonstration of efficacy and human food safety of the antibiotic tulathromycin and CIDR-G progesterone devices for synchronization of estrus in goats and the target animal safety and human food safety of lasalocid as a coccidiostat in ring-necked pheasants.
NON-TECHNICAL SUMMARY: Relatively few antibiotics, coccidiostats and reproductive aids are labeled for use in minor animal species in the U.S. Producers are ofen unable to control diseases, prevent animal suffering and compete economically. The Minor Use Animal Drug Program is funded by the USDA with the goal of assisting producers of minor animal species by providing information on the safe and efficacious use of drugs that are commonly in use in major animal species. The expected outcomes of this program are to promote the economic viability of small farms, lessen animal suffering due to diseases and ensure the safety and wholesomeness of the food supply.
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APPROACH: Human food safety studies with tulathromycin, CIDR-G devices and lasalocid will be conducted by using each product according to proposed label directions, harvesting target tissues from the treated animals and determining the residues at proposed withdrawal times. Target animal safety studies are performed by testing for adverse clinical and pathological effects with increasing doses of the drug. The efficacy studies with antibiotics can be determined by comparing the pharamacokinetics of the drug with the amount needed to inhibit growth of the target bacteria causing infections. The efficacy of CIDR-G devices is measured by their ability to synchronize estrus. The impact of these studies will be to provide data to support the approval of these products and demonstrate their safety in minor animal species.