The Minnesota Department of Agriculture (MDA) Laboratory Services Division is seeking funding under FDAfunding opportunity RFA-FD-12-018, 'FDA FERN Microbiological Cooperative Agreement ContinuationProgram (U18)'In our cooperative agreement proposal, we establish that the MDA laboratory meets all eligibility requirementsfor this funding opportunity. Further, we demonstrate that the MDA laboratory is well-positioned to carry out thegoals of the FDA FERN Microbiological Cooperative Agreement Program in terms of its staff, laboratoryfacilities and equipment, food testing capabilities, laboratory quality management system and through itsongoing participation in FERN training, surveillance, proficiency testing and cooperative agreement programs.A Research Strategy is submitted in the application package addressing: 1. Three key project areas outlined in the program announcement a. Participation in FDA/FERN sample analysis. b. Providing analytical data for potential regulatory utilization. c. Participation in small-scale method development, method validation and matrix extension work. 2. Specific issues included in the 'Special Instructions' portion of the announcement a. Laboratory Facilities b. Laboratory Personnel Qualifications c. Laboratory Management Practices d. Sample Analysis Commitment e. Ability and willingness to perform data entry into eLEXNET f. Ability and willingness to inform the FERN NPO immediately upon detecting a positive sampleThe Research Strategy responds to each item outlined above, and demonstrates how the MDA microbiologylaboratory will contribute toward meeting the objectives of the FDA FERN Microbiological CooperativeAgreement Program. The expected benefit of this cooperative agreement to FDA FERN is to leverage theconsiderable resources available to FERN through MDA. MDA laboratory staff will be able to carry out FERNsurveillance assignments, outbreak and surge capacity response, proficiency tests and method developmentand validation studies for a variety of threat agents.Proec Summary/Absrac-tMinnesotaDepartmentofAriulture
The MDA Laboratory Services Division will work with the FDA to provide increased sample analyses in the event of food outbreaks, or other large-scale food emergency events requiring surge capacity testing of implicated food samples. Federal or State surveillance assignments will also be a source of samples for lab analysis. Numbers of samples and scheduling of samples will be done by the FERN NPO in coordination with State lab authorities. The cooperative agreement will also be utilized to implement standardized analysis results through the usage of standardized methods, equipment platforms, analytical worksheets and electronic reporting. Proec Narraiv-eMinnesotaDepartmentofAriulture
