FDA CVM VET-LRN PROGRAM (U18) GRANT PROPOSAL FOR FOA # PA-12-194 Abstract This grant proposal from the Ohio Department of Agriculture (ODA) is in response to a Funding Opportunity Announcement (FOA) from the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) Veterinary Laboratory Response Network Study 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 many reasons including the extensive experience of the ADDL's professional and technical staff. The qualifications of the technical professional and staff are presented. As part of the 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 as well as the laboratory's ability and willingness to complete the proposed research in a timely manner. Several additional documents including the internal Standard Operating Procedures (SOP), Proficiency Testing (PT) results, and certificate of AAVLD accreditation are provided along with the

Public Health Relevance

to showcase the laboratory's ability to provide the capacity and capability to conduct the project. We are confident that we can meet the objectives of this project and look forward to the opportunity to work with the FDA and other labs in its initiation. The Project narrative is attached under Line Item #3 (Research Strategy) in the PHS 398 Research Plan Component

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
3U18FD004622-04S1
Application #
9117764
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2012-09-01
Project End
2017-08-31
Budget Start
2015-09-01
Budget End
2016-08-31
Support Year
4
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Ohio State Department of Agriculture
Department
Type
DUNS #
808847628
City
Reynoldsburg
State
OH
Country
United States
Zip Code
43068