FDA CVM VET-LRN PROGRAM (U18) GRANT PROPOSAL FOR FOA # PA-12-194AbstractThis grant proposal from the Ohio Department of Agriculture (ODA) is in response to aFunding Opportunity Announcement (FOA) from the Food and Drug Administration's(FDA) Center for Veterinary Medicine (CVM) Veterinary Laboratory Response NetworkStudy for the Vet-LRN Program (U18) FOA # PA-12-194.The purpose of this proposal from ODA's Animal Disease Diagnostic Laboratory (ADDL)is to address the following three key project areas:1. Participation in FDA/Vet-LRN sample analysis in the event of animal food or drug related illnesses or other large-scale animal food/feed emergency events requiring surge capacity testing of implicated diagnostic or animal food samples.2. Providing analytical data using standardized methods, equipment platforms, and electronic results reporting methodologies. Participation in proficiency testing and method training provided by the Vet-LRN Program Office (VPO) at the Center for Veterinary Medicine and implementation of standardized quality management systems for laboratories.3. Participation in small-scale method development, method validation and matrix extension work as determined by the VPO.A successful implementation of the project outlined in the proposal is predicted for manyreasons including the extensive experience of the ADDL's professional and technicalstaff. The qualifications of the technical professional and staff are presented. As part ofthe proposal, a detailed view of the laboratory facilities and quality system are provided.This grant proposal also addresses the CVM request for sample analysis commitment aswell as the laboratory's ability and willingness to complete the proposed research in atimely manner. Several additional documents including the internal Standard OperatingProcedures (SOP), Proficiency Testing (PT) results, and certificate of AAVLDaccreditation are provided along with the project narrative to showcase the laboratory'sability to provide the capacity and capability to conduct the project. We are confident thatwe can meet the objectives of this project and look forward to the opportunity to workwith the FDA and other labs in its initiation.
