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

FDA FERN Cooperative Agreement Continuation Program (U18) FAQs

1) What is the FDA FERN Cooperative Agreement Continuation Program (U18)?

It is a discretionary cooperative agreement opportunity from the U.S. Food and Drug Administration (FDA) intended to strengthen the Food Emergency Response Network (FERN) by supporting qualified microbiological, chemical, and radiological laboratories.

2) What is the main goal of this funding opportunity?

The overall goal is to expand and maintain surge testing capacity and technical expertise at state, local, and tribal laboratories so they can quickly analyze food and food-related environmental samples during outbreaks, contamination incidents, or other large-scale food emergency events.

3) What problem is the program designed to solve during major incidents?

When a major incident occurs and sample volume spikes, the program is designed so FDA can rely on a coordinated network of capable laboratories that use consistent methods, produce comparable results, and report findings rapidly using standardized formats.

4) What types of laboratories does the program support?

The program supports qualified laboratories with microbiological, chemical, and radiological testing capabilities.

5) What kinds of samples might participating laboratories analyze?

Participating labs may analyze food samples and food-related environmental samples connected to foods, particularly during outbreaks, contamination events, or other large-scale food emergency situations.

6) Where do the samples come from?

Samples may be collected by federal, state, or local agencies. Some participating laboratories may also be assigned sample collection responsibilities if they have that capability.

7) Is this program only for emergency response work?

No. While emergency response readiness is central, the program also supports routine surveillance assignments. Federal or state surveillance work can create ongoing sample streams that help keep laboratory capabilities active and validated.

8) How is testing work coordinated across grantees?

The FDA FERN National Program Office (NPO) coordinates the number of samples and the timing of work with each grantee.

9) How many samples per year does the announcement estimate?

The announcement notes an estimated need for analysis of up to 480 emergency response and surveillance samples per year across the supported efforts.

10) What does it mean that this is a cooperative agreement rather than a traditional grant?

Because it is a cooperative agreement, recipients should expect substantial programmatic involvement from FDA through the FERN NPO, including coordination of work and direction on certain technical activities.

11) What kind of FDA involvement should recipients expect?

Recipients should expect substantial involvement from FDA through the FERN NPO, including coordinating sample volumes and timelines, and directing participation in targeted method development, method validation, and matrix extension activities.

12) Are grantees only expected to run existing tests?

No. In addition to performing analytical testing, participating laboratories may be required to participate in targeted, short-term method development and method validation projects when directed by the FERN NPO.

13) What is "matrix extension" in the context of this opportunity?

Matrix extension means laboratories may need to adapt or confirm methods for additional food types or sample matrices. This can be needed quickly to support real-time outbreak decision-making, because the implicated product may vary widely.

14) Why does the program emphasize method standardization?

Standardization is a priority so the network can generate defensible, comparable results across jurisdictions, especially during emergencies when rapid, consistent decision-making is critical.

15) What tools or approaches are used to achieve standardized results across the network?

The program is intended to implement standardized analytical results through standardized methods, common equipment platforms (including equipment purchased with award funds), standardized analytical worksheets, and electronic reporting.

16) Are laboratories expected to use electronic reporting?

Yes. Electronic reporting is specifically mentioned as part of the approach to achieve standardized analytical results and rapid, standardized reporting.

17) What quality expectations apply to participating laboratories?

Each participating laboratory is expected to maintain a quality management system to support defensible and comparable results.

18) Is ISO/IEC 17025 accreditation required?

ISO/IEC 17025 accreditation is not presented as an absolute requirement, but laboratories are explicitly encouraged to obtain ISO/IEC 17025 accreditation or adopt a comparable quality system.

19) What does FDA appear to be looking for in applicant laboratories?

FDA was looking for laboratories that can reliably deliver surge analytical testing during emergencies, operate within a standardized national framework, and collaborate closely with FDA on methods, validation, reporting, and quality systems.

20) What is the Funding Opportunity Number and CFDA listing for this program?

The Funding Opportunity Number is RFA-FD-15-019 and the CFDA number is 93.103.

21) When was the opportunity posted and what was the application deadline?

The opportunity was posted on April 20, 2015, and the application deadline was June 29, 2015.

22) What was the estimated total funding amount?

The estimated total funding amount was $1.2 million.

23) How many awards did FDA anticipate making?

FDA anticipated making about five awards.

24) What were the award ceiling and floor?

The award ceiling was $240,000 and the award floor was $10,000.

25) Is cost sharing or matching required?

No. The opportunity indicates there was no cost sharing or matching requirement.

26) Who was eligible to apply?

Eligible applicants included state governments, county governments, federally recognized Native American tribal governments, and public or state-controlled institutions of higher education.

27) What is the listed activity category and administering agency?

The activity category is listed as Food and Nutrition, and the administering agency is the Food and Drug Administration.

28) How does the program support faster outbreak and emergency testing?

It supports faster response by maintaining surge capacity, coordinating work through the FERN NPO, requiring standardized methods and reporting, and ensuring labs can rapidly extend or validate methods for new food types or matrices during active incidents.

29) Who can be contacted for help accessing the full announcement?

The announcement identifies Daniel Lukash, Grants Management Specialist, as the contact for assistance accessing the full announcement: 240-402-7596; daniel.lukash@fda.hhs.gov.