Opportunity Information: Apply for RFA FD 20 013
Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) is an FDA cooperative agreement opportunity (RFA-FD-20-013, CFDA 93.103) designed to strengthen the national food safety system by improving how state and local laboratories test human food and animal feed. The FDA Office of Regulatory Affairs (ORA), Office of Partnerships (OP) set this up as a limited competition specifically for non-profit, national associations or organizations that represent state and local food testing laboratories. The basic idea is that an association can coordinate across many laboratories, build consensus on common problems, and deliver shared tools, training, and guidance that individual labs might struggle to develop on their own. Clinical trials are not part of this program.
The program focuses on the real-world work of public laboratories: surveillance testing, emergency response testing, and supporting investigations of foodborne illness outbreaks. FDA highlights the importance of building laboratory capacity (having enough staff, equipment, and throughput) and capability (having the right methods, quality systems, and technical expertise), while also maintaining and expanding ISO/IEC 17025 accreditation. Another major emphasis is supporting and extending progress made through GenomeTrakr, the national network that uses whole genome sequencing to help identify and trace foodborne pathogens. Because food safety involves many partners, the award expects strong collaboration and alignment with other federal efforts and national initiatives, plus close coordination with state and local programs.
The single award (expected awards: 1) was posted with an anticipated annual budget ceiling of $500,000. Because this is a cooperative agreement, FDA is not just providing funds and stepping back; FDA expects substantial involvement in shaping, reviewing, and approving key deliverables. For example, training programs and meeting agendas must be reviewed and approved by FDA before they are delivered or distributed, and FDA will monitor training effectiveness by reviewing participant evaluations.
The project work is organized around a set of objectives, with progress assessed twice a year. A central responsibility is to research, design, and implement training, workshops, and educational resources that help both FDA-funded labs under the Laboratory Flexible Funding Model (LFFM) and labs that are not funded by FDA. Training topics are practical and accreditation-driven, such as laboratory procedures, quality management systems, document control, continuous improvement, sample collection, risk assessment, and the mechanics of data transfer to NCBI and FDA systems. The association is expected to deliver training through multiple formats, including webinars, teleconferences, in-person workshops, on-site technical sessions, and web-based resource hubs, and to address both lab-specific needs and broader national needs.
Another major component is convening the community. The awardee must plan and host annual face-to-face meetings, including full event logistics, registration, materials, and evaluation. Two specific meetings are called out: the LFFM face-to-face meeting (including discipline-specific breakout sessions) and the GenomeTrakr face-to-face meeting. These meetings are meant to drive consistent practices, peer learning, and coordination across laboratories and with FDA.
The opportunity also includes hands-on support to laboratories, especially those that do not already receive FDA funding. The awardee must provide direct technical assistance to state human and animal food testing laboratories that are working toward ISO/IEC 17025 accreditation, which can include guidance on quality systems, documentation, method validation frameworks, and readiness activities that support a successful accreditation process. This complements the training mission by pairing broad education with targeted, lab-by-lab assistance.
A key technical deliverable is the development and maintenance of a "crosswalk" comparing state and FDA regulations, standards, and expectations for food-related illness and outbreak response. This crosswalk must cover areas such as sample collection requirements, analytical methods, compliance standards, and action levels, along with other elements agreed upon with FDA. The association may need to survey laboratories or use other structured outreach to gather the needed information, and then provide the crosswalk to FDA in an agreed-upon format. Importantly, the awardee must analyze what the crosswalk data show, identify gaps or inconsistencies, and translate those findings into improvements such as best practices, training content, and other practical resources.
Modernizing and harmonizing data exchange is another core theme. The awardee must help states implement the National Food Safety Data Exchange (NFSDX), particularly the exchange of sample data. Related to that, the association is expected to promote FDA partnership tools like the ORA Partners Portal (ORAPP) and Laboratory Business Services (LBS), along with NFSDX, by doing outreach at conferences and actively recruiting laboratories to participate. The messaging should be concrete: these tools allow partner organizations to send and receive data electronically with FDA and with other state agencies, which can speed investigations, reduce manual work, and improve consistency. The association must also integrate FDA-provided NFSDX training modules into its existing training programs when appropriate, and collaborate with the Partnership for Food Protection IT Working Group to support data system transition activities.
On the genomic surveillance side, the awardee must work with FDA to research, develop, and distribute best practices documents, protocols, and standard operating procedures for GenomeTrakr. In addition, the awardee must look across GenomeTrakr and PulseNet activities and produce a written report describing where the networks overlap, where they differ, and where collaboration opportunities exist. This is meant to reduce duplication, improve interoperability, and help the broader public health and food regulatory ecosystem make better use of sequencing and related laboratory data.
Finally, the award includes a travel support function to help laboratorians from non-FDA funded organizations participate in key trainings and meetings. This includes travel assistance for GenomeTrakr-contributing laboratorians and support for attendance at events such as the LFFM annual meeting, FDA Office of Training, Education and Development (OTED) trainings, the InFORM meeting, and other FDA-identified educational opportunities intended for federal, state, and local public health and laboratory scientists. The awardee is also expected to coordinate with the Partnership for Food Protection Laboratory Working Group to support national laboratory initiatives, including work on best practices for data sharing and data acceptability.
Overall, the opportunity is built around one unifying goal: use a national association as the organizing engine to help state and local food and feed laboratories become more consistent, better trained, more accredited, and more connected through shared standards and electronic data exchange, ultimately improving the speed and effectiveness of foodborne illness detection and outbreak response nationwide.Apply for RFA FD 20 013
- 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 "Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial 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 Jan 21, 2020.
- Applicants must submit their applications by Mar 23, 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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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