Opportunity Information: Apply for PAR 20 105
The Laboratory Flexible Funding Model (LFFM) (U19) cooperative agreement is an FDA funding opportunity designed to strengthen prevention-focused food safety testing in line with the Food Safety Modernization Act (FSMA). The central idea is to expand and modernize how laboratory testing supports a risk-informed, preventive food safety system, so contaminated products are more likely to be caught before they reach consumers and so FDA and its regulatory partners can better understand hazards, track trends, and evaluate which control strategies actually reduce risk. The program focuses on generating a high volume of actionable testing outputs that can feed national and state decision-making, including tracking and trending of hazards, earlier identification of emerging issues, and targeting of future surveillance and sampling.
The work supported under this opportunity centers on three main types of laboratory analysis: (1) product testing of foods, (2) whole genome sequencing of positive isolates, and (3) emergency response and emerging issues testing. Product testing covers both human and animal food, including finished products (such as retail or packaged goods), in-process materials, and raw ingredients. These analyses are aimed at identifying harmful contaminants and, when applicable, verifying that products contain ingredients at the levels stated on labels. Whole genome sequencing is intended to add stronger organism-level characterization when a pathogen is found, which can improve outbreak detection, linkage, and source tracing. Emergency response and emerging issues testing is meant to give FDA and partners surge capacity and situational awareness; it can include environmental samples (for example water or soil) and/or product samples depending on the situation. Emergency response testing is particularly tied to outbreak investigations where rapid lab results help identify the source of illness, while emerging issues testing supports proactive surveillance based on trends, signals, or intelligence identified by FDA or the funded laboratory and its partners.
A defining feature of the LFFM is flexibility in sample sources and operational triggers. Samples tested under the cooperative agreement may come from an approved sampling plan, an outbreak or other emergency response, national special security exercises, or a specific FDA assignment. In practice, this means participating laboratories must be prepared to pivot between routine surveillance work and time-sensitive response work. Samples may also be collected by entities other than the performing laboratory, including FDA itself or third parties, and then submitted to the funded laboratory for analysis. The award is intended not only to pay for testing, but also to increase state laboratory throughput and capability by providing added resources that strengthen capacity inside the participating laboratories.
Although the project is led by the recipient laboratory leadership, the funding mechanism is a cooperative agreement (U19), which means FDA has substantial programmatic involvement beyond standard grant oversight. The project director or principal investigator retains primary responsibility for planning, directing, and executing the work, but FDA actively participates through ongoing monitoring and technical and program review. FDA involvement described in the announcement includes monitoring progress via written reports, site visits, calls, and email; reviewing small, short-term method development, method validation, and matrix extension efforts; reviewing and approving proposed sample collections and testing; reviewing data packages when samples are potentially violative; and reviewing and approving budget modifications. FDA and the recipient also revisit needs annually, updating testing priorities (including the hazard/commodity pairings that guide sampling emphasis), identifying opportunities for development, and reviewing and approving annual testing proposals. When violative findings occur, FDA works with the laboratory and the laboratory’s regulatory program to discuss response strategies, underscoring that results are intended to support real-world regulatory and public health actions.
Administratively, the opportunity is offered by the Department of Health and Human Services, Food and Drug Administration, under Funding Opportunity Number PAR-20-105. It is categorized as discretionary funding and uses the cooperative agreement instrument, with the activity area listed under agriculture, consumer protection, and food and nutrition (CFDA 93.103). Clinical trials are not allowed. Eligible applicants are broad and include state, county, and local governments; special district governments; public and state-controlled institutions of higher education; private institutions of higher education; and eligible Native American tribal governments and organizations. The posted award ceiling is $1,500,000, and the opportunity anticipated up to 100 awards, reflecting an intent to build a sizable network of participating laboratories to support nationally consistent, prevention-oriented food safety testing capacity.Apply for PAR 20 105
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 05, 2020.
- Applicants must submit their applications by Apr 06, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 100 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Private institutions of higher education.
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