Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed

The Food Safety Modernization Act (FSMA) outlines a new approach to food safety that is risk-informed and preventive in focus. Recognizing that sample testing can play a greater role in helping the Agency and our regulatory partners prevent contaminated product from reaching consumers, understand risks, and assess the value of strategies to control those risks, Food and Drug Administration has begun the process of rethinking how the agency deploys its resources.

In order to develop prevention-based systems, data and other information are needed to help identify and address hazards. There are different types of sample analysis that will be the focus of this project: product, whole genome sequencing of positive isolates, and emergency response/emerging issues sample analysis.

Human and animal food (livestock or pet) finished products as well as in-process and raw ingredient samples are analyzed to ensure they do not reach consumers with harmful contaminants, or to verify they contain ingredients at levels as declared on product labeling.

Emergency response and emerging issue testing can take the form of either environmental (e.g., water, soil) or product testing and could include both. Emergency response testing is routinely conducted in response to outbreaks of foodborne illness to help identify the source of the disease-causing pathogen. Emerging issues testing allows the agency to gather information about potential food safety issues based on trends or intelligence the Agency or grantee might have.

This project will be utilized to support the above-mentioned initiative by producing a large quantity of sample outputs that will drive a risk-based and prevention focused food safety system that both the FDA and our State partners can utilize for tracking and trending, early identification of emerging issues, and evaluation for future sampling initiatives and areas of focus. Participating laboratories will be equipped with additional resources that can be employed to build and increase sample throughput capacity and capability within their state.

Samples analyzed under this cooperative agreement could derive from a variety of sources including but not limited to: an approved sample plan, emergency outbreak situations, national special security exercises, or an FDA assignment. Laboratories may be requested to participate in national special security exercises and FDA assignments. Samples may be collected by other organizations (e.g., FDA or a 3rd party) and submitted to participating laboratories for analysis.

The PD(s)/PI(s) shall retain the primary responsibility and dominant role for planning, directing, and executing the proposed project, however, the cooperative agreement award mechanism will result in substantial involvement by the FDA. Substantial involvement includes, but is not limited to:

1. Monitoring of progress through written reports, on-site visits, conference calls, and emails, as needed;

2. Review of small-scale, short-term method development, method validation, and matrix extension projects;

3. Review and approval of proposed sample collections and testing;

4. Review of laboratory data packages for violative samples;

5. Review and approval of budget modifications;

6. Annually, in conjunction with the grantee, determine changes in the overall testing needs to be applied to the recommended hazard/commodity pair table and identify opportunities for development; and

7. Review and approve annual testing proposals submitted by the laboratories.

8. In conjunction with FDA and the laboratory's regulatory program, discuss response strategies for violative samples.