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

Public Health Relevance

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

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18FD003862-05
Application #
8533926
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2009-09-21
Project End
2015-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2013
Total Cost
Indirect Cost
Name
Minnesota State Department of Agriculture
Department
Type
DUNS #
804886208
City
Saint Paul
State
MN
Country
United States
Zip Code
55155