FDA FERN Microbiological Cooperative Agreement Continuation Program: Minnesota De

Minnesota State Dept Of Agriculture, St Paul MN

Investigators

Abstract

PROJECT SUMMARY / ABSTRACT The Minnesota Department of Agriculture (MDA) Laboratory Services Division is seeking funding under FDA funding opportunity RFA-FD-12-018, FDA FERN Microbiological Cooperative Agreement Continuation Program (U18) In our cooperative agreement proposal, we establish that the MDA laboratory meets all eligibility requirements for this funding opportunity. Further, we demonstrate that the MDA laboratory is well-positioned to carry out the goals of the FDA FERN Microbiological Cooperative Agreement Program in terms of its staff, laboratory facilities and equipment, food testing capabilities, laboratory quality management system and through its ongoing 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 sample The Research Strategy responds to each item outlined above, and demonstrates how the MDA microbiology laboratory will contribute toward meeting the objectives of the FDA FERN Microbiological Cooperative Agreement Program. The expected benefit of this cooperative agreement to FDA FERN is to leverage the considerable resources available to FERN through MDA. MDA laboratory staff will be able to carry out FERN surveillance assignments, outbreak and surge capacity response, proficiency tests and method development and validation studies for a variety of threat agents. Proec Summary/Absrac-tMinnesotaDepartmentofAriulture