Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed] | RFA FD 22 021

Opportunity Information: Apply for RFA FD 22 021

Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) is an FDA cooperative agreement opportunity aimed at strengthening how food safety regulators share, manage, and use data across the United States. The grant sits in the broader push created by the FDA Food Safety Modernization Act (FSMA) to move the national system away from reacting to outbreaks after they happen and toward preventing them through better coordination, consistent standards, and faster access to reliable regulatory and laboratory information. The opportunity is designed to support a more fully Integrated Food Safety System (IFSS), where federal and state, local, tribal, and territorial partners can work as a connected network during routine oversight as well as during outbreaks, recalls, and other emergencies. It also directly supports the FDA focus on Domestic Mutual Reliance, meaning FDA and states with comparable programs should be able to rely on each other’s inspections, evidence, and actions, rather than duplicating work due to incompatible systems or missing information. In parallel, the project is framed around a One Health approach, acknowledging that human health, animal health, food production, and the environment are interconnected, so effective prevention and response depend on being able to share relevant data across sectors.

At the center of the award is the planning, development, implementation, operation, and long-term maintenance of a shared data management system intended for SLTT partners working in both human and animal food programs. The FDA’s Office of Regulatory Affairs is looking for a grantee that can build and steward an integrated IT infrastructure that helps regulators do day-to-day work and also makes high-quality information easier to exchange with FDA. The system is expected to function as a practical, usable platform for regulatory programs, not just a data warehouse. It should support core regulatory activities such as maintaining a firm inventory with strong firm search and firm history functions, storing and sharing inspection and investigation reports, handling laboratory data, tracking consumer complaints, managing recall information, and documenting enforcement actions. It is also expected to strengthen prevention and rapid response by supporting product traceability and trend detection in supplier chains, which can speed up early identification of emerging hazards or patterns that point to a developing outbreak.

A major theme is that the system should help states and other partners meet and maintain conformance with regulatory program standards. In practice, that means the platform should have features that support risk-based categorization of firms, work planning, inspection frequency management, tracking compliance follow-up when violations are found, and monitoring complaint intake and resolution. The underlying idea is that better, more consistent data management strengthens program quality and makes state-generated regulatory information more usable for mutual reliance. While FDA anticipates that broader FDA-to-state data exchange connections would ultimately be established under separate agreements and consistent with FDA legal authorities, this cooperative agreement is meant to lay the technical and operational groundwork so that exchange can happen smoothly and securely when those agreements are in place.

The opportunity places heavy emphasis on building and sustaining a real user community, not simply delivering software. Applicants are expected to define stakeholders, identify user needs, and formalize participation through contracts, MOUs, or similar agreements. Those agreements are expected to address practical and sensitive issues, including rules for handling non-public information, cost projections for each participating user to cover development and ongoing operations, roles and responsibilities, and liability conditions. The grantee is expected to work directly with lead users and FDA throughout development and execution, and to recruit broader adoption across the human and animal food regulatory community through outreach. Importantly, the project must include a continuous improvement framework and a cost-sharing model so the system can be sustained beyond the grant period. The system may also support non-FDA programs if users want that functionality, but the grant funds can only pay for work tied to FDA’s mission and regulatory responsibilities, so any added non-FDA use would need to be funded by the users or other sources.

On the technology side, interoperability with FDA infrastructure is a core requirement. The project is expected to align with and integrate into ORA Data Exchange (DX), which is FDA’s bidirectional platform for secure information sharing with regulatory partners. ORA DX includes the ORA Partners Portal and the National Food Safety Data Exchange system-to-system API, along with tools like an XML-based Enhanced DX Client for lab sample submissions. ORA DX also connects with FDA systems such as FACTS and eSAF, with planned integration with ALIS. The grantee is expected to develop, maintain, and support the state-facing data management system in a way that keeps pace with FDA updates and maintains feature parity and interoperability over time, based on timelines agreed to with FDA’s information technology stakeholders. The funding announcement calls for sustainable software development practices that reduce duplicated effort across jurisdictions, with examples like open-source development, shared frameworks, published standards and documentation, and strong API management. Operational expectations include contingency planning for continuity of data availability, coordinated architecture and design processes to make onboarding and troubleshooting easier for states, and ongoing monitoring, testing, quality assurance, and rapid resolution of outages and defects. Because this system will handle sensitive regulatory information, vendors involved in the work may need non-public information disclosure agreements with participating partners, and the applicant must have (or be able to obtain before the award starts) an FDA information sharing agreement under 21 CFR 20.88(e). Information sharing is limited to pre-decisional information and only for the purposes described in the award.

The project is also expected to align with FDA’s New Era of Smarter Food Safety initiatives, particularly around interoperability that supports faster tracebacks and traceforwards and broader improvements in domestic mutual reliance. It is positioned as a building block toward a more networked “Food Safety Information Network” where FDA and states can coordinate on work planning, risk prioritization, inventory comparisons, and sample collection in a more standardized way. One Health goals show up in expectations that the system be able to connect and coordinate across jurisdictions and sectors, for example supporting information sharing that could help identify and address environmental contamination linked to produce outbreaks. Applicants must also address data security, privacy, and allowable use, identify barriers to adoption, and provide clear documentation for data retention, records management, and repository security policies.

From a project management and operational readiness standpoint, the application is expected to explain how the work will be monitored, who will oversee it, how often oversight will occur, and how the project will support migration from existing systems to the new platform without disrupting regulatory operations. The announcement also calls for adequate staffing and expertise to meet timelines, a quality assurance approach to protect the accuracy and integrity of datasets and metadata, and administrative, technical, and physical safeguards consistent with confidentiality, risk management, and continuous monitoring requirements for sensitive data. Procurement is another explicit area: the grantee must implement procurement practices that support the project objectives while promoting diversity, equity, inclusion, and accessibility, including a diversity procurement strategy that makes affirmative efforts to solicit disadvantaged and women-owned small businesses when possible, consistent with relevant federal procurement guidance.

Eligibility is narrow and intentionally limited. The opportunity is only open to certain nonprofit food safety training entities that collaborate with at least one institution of higher education. In practice, competition is limited to national organizations or associations whose membership includes state, local, territorial, and/or tribal food safety regulatory professionals or agencies, and that can demonstrate they understand state-specific regulatory data needs, existing state-federal data sharing initiatives, procurement realities, and the regulatory program standards tied to conformance. The rationale is that these national organizations are positioned to drive national-scale adoption through established relationships and communication channels such as meetings, websites, and listservs, and to coordinate the kind of shared governance and continuous improvement process needed for a system meant to serve many jurisdictions.

Administrative details included in the source notice describe the award as an FDA discretionary cooperative agreement (U2F; clinical trial not allowed) under CFDA 93.103, with an award ceiling of $6,000,000 and an original closing date of February 22, 2022, under funding opportunity number RFA-FD-22-021. The cooperative agreement structure signals that FDA expects substantial involvement and collaboration during the project, particularly around interoperability with FDA’s ORA DX ecosystem and the information-sharing and governance arrangements needed to make the system useful, secure, and sustainable over time.

• The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [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 2022-01-11.
• Applicants must submit their applications by 2022-02-22. (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 $6,000,000.00 in funding.
• Eligible applicants include: Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Others.

Apply for RFA FD 22 021

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