FDA FERN Microbiological Cooperative Agreement Continuation Program (U18) | Apply Online

Opportunity Summary:

The FDA FERN Microbiological Cooperative Agreement Continuation Program (U18) is a continuation cooperative agreement designed to strengthen the Food Emergency Response Network (FERN) by expanding microbiological testing capacity in state, local, and tribal public health and food testing laboratories. The central goal is surge readiness: when a foodborne outbreak or other large-scale food emergency occurs, FDA needs a reliable network of capable laboratories that can rapidly analyze a high volume of implicated samples. Those samples may be food products themselves or environmental samples tied to foods (for example, swabs from processing environments), and they can be collected by federal, state, or local agencies depending on the incident and jurisdiction.

A key feature of the program is operational coordination through the FERN National Program Office (NPO). Rather than labs independently deciding what and when to test, the NPO works with state and local laboratory authorities to assign sample numbers and schedules, ensuring testing demand is distributed strategically across the network. In addition to outbreak response work, routine federal or state surveillance assignments are also expected to feed into the testing workload, helping labs maintain readiness and providing ongoing monitoring data that supports food safety and security.

The FDA indicates that an annual throughput of around 500 samples per lab is considered optimal, which signals the scale of work the agency is trying to sustain across the network. This is not just a capacity-building effort in the abstract; it is about maintaining a predictable, measurable level of testing activity so that labs remain practiced, responsive, and equipped to pivot quickly during an emergency. Some participating laboratories that already have sample collection capabilities may also be tasked with collection activities, which can be important during outbreaks when timely and properly controlled sampling is as critical as the analytical work itself.

Standardization is another major pillar of the opportunity. The cooperative agreements are used to drive consistent, comparable microbiological results across many laboratories by requiring the use of standardized methods and workflows. This includes standardized equipment platforms (with equipment provided through the grant), standardized analytical worksheets, and electronic reporting of results. To make sure that labs can implement these standards effectively, the program includes training and proficiency testing associated with each method and equipment platform. In practical terms, this means the award is not only purchasing instruments or funding staff time; it is also purchasing alignment across the network so that results produced in one lab are technically consistent with results produced elsewhere, which is crucial for outbreak decision-making.

The program also emphasizes foundational laboratory quality practices. Each grantee is expected to put minimal quality management systems in place, building from whatever systems already exist in the laboratory and refining them through consultation between the FERN NPO and the lab leadership. This suggests a pragmatic approach: the FDA is not necessarily imposing an entirely new quality framework from scratch, but it is requiring a baseline level of quality infrastructure that supports defensible data, reproducibility, and reliable reporting under time pressure.

Beyond routine testing, grantees are expected to support small-scale, short-term method development and method validation projects as directed by the FERN NPO. This component helps the network adapt to emerging pathogens, new commodities, and evolving analytical needs without waiting for long research timelines. The announcement also highlights "matrix extension assignments," which generally refers to extending validated methods to additional food types or environmental matrices. These assignments can come with rapid turnaround expectations, especially when tied to outbreak response, reinforcing that responsiveness and flexibility are central expectations for participating labs.

From a funding and administrative standpoint, this FOA (RFA-FD-12-018) is a cooperative agreement, meaning FDA anticipates substantial involvement in the project beyond a typical grant. The opportunity was posted May 4, 2012, with a closing date of July 2, 2012, and it was later archived August 1, 2012. It falls under CFDA 93.448 (Food Safety and Security Monitoring) and is categorized across several activity areas including agriculture, food and nutrition, health, environment, and research and development. The program anticipated 15 awards with an estimated total funding amount of $4,000,000. Individual awards were set at a fixed level, with both the award ceiling and floor listed as $250,000, and there was no cost sharing or matching requirement. Eligible applicants were state governments, aligning with the program focus on state and other public-sector laboratories that can serve as core nodes in a national response network.

Funding is intended to cover practical, implementation-focused needs that directly support increased testing capacity and standardization. The description specifies support for equipment (including standardized platforms provided by the grant), one full-time equivalent (FTE) staffing position, and some portion of annual operating and maintenance costs. In effect, the program is structured to help labs not only acquire the tools needed to meet FERN requirements, but also to sustain ongoing readiness and day-to-day operational ability to process assigned samples, report electronically, and participate in training, proficiency testing, and directed method work.

For applicants needing assistance accessing the full announcement, the FOA listed a grants management contact: Gladys Melendez Bohler, Grants Management Specialist/Officer, reachable by phone at 301-827-7175.

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