FDA- Laboratory Flexible Funding Model (MICROBIOLOGY)

NIH RePORTER · FDA · U19 · $400,000 · view on reporter.nih.gov ↗

Abstract

Project summary/Abstract The Michigan Department of Health and Human Services, Bureau of Laboratories (MDHHS-BOL) Infectious Disease Division, Microbiology Section has built a strong working relationship with USDA FERN for more than 15 years. The MDHHS Microbiology section is the Midwest regional laboratory for the CDC PulseNet program with enhanced capacity and capabilities for Whole Genome sequencing (WGS). BOL is accredited to ISO 17025 standard by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP, LLC) in their Food Laboratory Accreditation Program (Food LAP); has a Certificate of Registration with the CDC Federal Select Agent Program (FSAP) and a USDA APHIS permit; has been designated as an Tier-1 Biological lab within the Laboratory Response Network (LRN) performing testing associated with foodborne outbreak investigations; and has experience with and facilities for the agents of bioterrorism. The objectives proposed here are intended to enhance the capacity and capabilities in the detection of bacterial pathogens in food products, thereby, supporting and improving the laboratory capacities for food defense assignments and outbreak response in State of Michigan. Objective 1: The primary goal is to provide surge capacity testing for the analysis of food products for BSL3 bacterial select agents and participate in FDA surveillance and special event activities. Objective 2: To study the genomic diversity of enteric pathogens associated with food borne illness collected from human food by WGS as a member of the GenomeTrakr network. This increased capability will allow MDHHS access to improved comparison and analysis of sequencing, which in turn, will improve outbreak investigations and food safety. Objective 3: To develop the capacity and capability for detecting Cyclospora in human food products. Following training and competency this would increase the lab’s ability to detect Cyclospora in the event of an outbreak. MDHHS would also be able to assist FDA in special events in testing for Cyclospora.

Key facts

NIH application ID
10175405
Project number
1U19FD007116-01
Recipient
MICHIGAN STATE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Principal Investigator
Marty Soehnlen
Activity code
U19
Funding institute
FDA
Fiscal year
2020
Award amount
$400,000
Award type
1
Project period
2020-09-01 → 2025-06-30