Laboratory Flexible Funding Model (LFFM)

The Laboratory Flexible Funding Model (LFFM) is a cooperative agreement initiative administered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). This funding opportunity is designed to strengthen state-level laboratory infrastructure and surveillance systems in support of a nationally integrated food safety system. Under the LFFM, the FDA collaborates directly with human and animal food (HAF) testing laboratories to bolster their microbiological, chemical, and radiochemical testing capabilities. The program reflects the preventive focus of the Food Safety Modernization Act (FSMA), emphasizing early detection, response, and mitigation of foodborne contaminants that threaten public health. The purpose of the LFFM is to support state laboratories by providing the financial and technical resources necessary for high-quality food testing and surveillance activities. Participating labs can engage in a wide array of analytical tracks, including microbiology, chemistry, and radiochemistry, which target specific areas such as human and animal food product testing, food defense, method development, and capability building. Each of these tracks is designed to generate valuable data used to evaluate contamination risks, inform regulatory actions, and support broader public health initiatives. Laboratories are encouraged to align their testing priorities with those of the FDA while also tailoring their approach to meet state-specific needs. Applicants may request support under multiple tracks and must meet several eligibility criteria depending on the track selected. For example, ISO 17025 accreditation is mandatory for most product testing tracks. A valid 20.88 information sharing agreement with the FDA is also required for all tracks except Whole Genome Sequencing. Additional documentation, including letters of support from state regulatory programs and affirmations of technical and operational capabilities, is required. Laboratories must demonstrate readiness to support surge capacity and participate in emergency response assignments coordinated by FDA or other agencies. The total funding available for FY 2025 is estimated at $25 million, with approximately 75 cooperative agreements expected to be awarded. Applicants may propose project budgets up to $1.5 million per application. The award period may span up to five years, depending on the project’s scope. Funding tiers are based on sample load and project type, with specific amounts allocated per analytical track. For example, microbiology product testing tracks offer tiered funding based on sample volume, while capability development projects may receive up to $200,000 in support. Method development and validation tracks are also funded up to specific limits depending on the project’s complexity. The LFFM has a recurring application cycle with deadlines extending through January 2028. Applications for the current cycle are due by March 31, 2025, at 11:59 PM Eastern Time. Subsequent application deadlines fall in January of each year through 2028. Letters of Intent (LOIs) are due approximately six weeks before each application deadline. Approved applicants receive key resources such as the LFFM Sample Guide and lists of eligible projects after submitting their LOIs. Technical sessions are held before each submission deadline to assist applicants, and early submissions are encouraged to avoid system-related errors. All applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional S2S system. Conformance to the application instructions outlined in the NOFO and NIH How to Apply guide is strictly enforced. Applications must clearly describe proposed analytical methods, demonstrate alignment with program goals, and provide documentation verifying compliance with program requirements. Projects will be reviewed for scientific merit in April of each application year, and awards are expected to begin in July. While this program does not support clinical trials, it plays a crucial role in enhancing laboratory capacity for foodborne illness prevention and public safety across the United States.

Submit LOI early to receive project list and sample guide; ensure ISO 17025 scope aligns with track selections; respond quickly to FDA communications.