Alliance to Support Integrated Public Health System Activities (U2F) Clinical Trials Not Allowed | RFA FD 21 029

Opportunity Information: Apply for RFA FD 21 029

The Alliance to Support Integrated Public Health System Activities (U2F) opportunity (RFA FD 21 029) is an FDA Office of Regulatory Affairs (ORA), Office of Partnerships (OP) cooperative agreement designed to strengthen the national food safety system by tightening coordination between FDA and state and local manufactured food regulatory programs. It is a limited-competition award, meaning eligibility is intentionally narrow: only national associations or organizations whose primary purpose is representing state food regulatory programs can apply. The project is explicitly non-clinical in nature (clinical trials not allowed) and sits in the agriculture/consumer protection/food and nutrition space (CFDA 93.103). FDA anticipates making a single award, with an award ceiling of up to $3,000,000. Funding is guaranteed for one year, with the possibility of up to two additional years of non-competitive continuation support, contingent on performance and the availability of federal funds.

At its core, the grant is about implementing the Food Safety Modernization Act (FSMA) vision of a prevention-based, risk-based, nationally integrated food safety system that works across federal, state, local, tribal, and territorial partners. Congress recognized that thousands of government agencies play roles in food safety, and FSMA effectively requires FDA to integrate those partners into a unified approach that protects consumers across both human food and animal food (including pet food). This cooperative agreement is one way FDA intends to operationalize that integration by reinforcing shared standards, shared tools, and shared workflows so that oversight of manufactured foods becomes more consistent, more data-driven, and more mutually reinforcing across jurisdictions.

A major pillar of the work is advancing and supporting the Manufactured Food Regulatory Program Standards (MFRPS). These standards are meant to provide a uniform foundation for how state programs design and manage their regulatory oversight of food manufacturing plants, reflecting best practices for high-quality regulatory programs. By improving state conformance with MFRPS, FDA and the states can better align inspection approaches, surveillance activities, and enforcement priorities, ultimately targeting hazards in facilities that manufacture, process, pack, or hold foods. In practical terms, the grant aims to make state programs more capable, more consistent with one another, and easier to coordinate with FDA in day-to-day food protection and in emergencies.

The opportunity lays out five overarching objectives: helping FDA meet FSMA provisions; supporting federal, state, and local efforts to build the National Integrated Food Safety System; creating durable systems for sharing and collaborating on best practices and technical tools (like sampling plans, procedures, guidance, and MOUs) that build mutual reliance; strengthening food safety and food defense training capacity to support MFRPS conformance and FSMA training expectations; and advancing both the MFRPS themselves and the Manufactured Food Regulatory Program Alliance (the Alliance) as a national mechanism for collaboration and continuous improvement.

The workplan expectations are detailed and operational. A central deliverable is building an online program portal that functions as a learning exchange and practical hub for manufactured food regulators. The portal is expected to include features like a subject matter expert registry, an organized index of regulatory guidance and topical resources, regulatory updates, and other information relevant to manufactured food programs. In parallel, the awardee is expected to grow a user community around that platform and support data management and information exchange between FDA and state regulatory agencies, with the explicit goal of promoting conformance with both human and animal food program standards and improving coordination.

The cooperative agreement also emphasizes structured, ongoing two-way communication with the states. The recipient is expected to create and maintain forums where state manufactured food regulatory programs can raise concerns and work through issues related to MFRPS implementation, the food safety inspection contract, training gaps, FSMA-related changes, and broader federal-state relationship challenges. This is meant to be more than occasional outreach; it is described as an organized mechanism to surface barriers, discuss them with the right stakeholders, and move toward workable solutions.

Another significant requirement is maintaining and continuously improving a web-based directory of state and local food protection officials that is publicly available and usable by federal, state, local, tribal, and territorial agencies. The grant calls for expanding the directory to cover additional agencies and roles and, importantly, establishing a system to keep the information accurate. The notice anticipates at least semi-annual verification and updates, implying the directory should be treated like living infrastructure rather than a static contact list.

A substantial portion of the effort is administrative and convening support for the Manufactured Food Regulatory Program Alliance and related national initiatives that promote integration. The awardee is expected to support committee structures, recruit and organize state program manager participation, stand up workgroups, schedule and host meetings (both virtual and in person), and handle the practical mechanics such as agendas, minutes, and membership support. The recipient also serves as the official repository for Alliance-created materials, including governance documents, by-laws, position statements, meeting records, and suggested MFRPS changes. Beyond routine operations, the recipient must host at least one annual in-person meeting lasting at least three days focused on helping state and local programs achieve MFRPS conformance, including logistics, registration, materials, and audiovisual support, plus systematic collection of participant feedback for improvement.

In addition to the Alliance meeting, the awardee must provide similar administrative support for the Rapid Response Teams (RRT) Program annual face-to-face meeting (also at least three days). That includes end-to-end logistics and on-site support, working with the RRT planning committee, and collecting structured feedback afterward. The funding also anticipates support for other meetings that help build an integrated food safety system, including meetings connected to the Partnership for Food Protection (PFP) and Food Protection Task Force efforts, again with an emphasis on strong logistics, coordination with FDA, and continuous improvement through evaluation.

Training and capacity-building are another central theme, with a strong emphasis on practical conformance support. The recipient is expected to identify, develop, deliver, and/or promote food safety and food defense training that supports MFRPS and FSMA provisions, and to provide financial assistance so state and local programs can attend key manufactured food trainings and meetings. The grant also calls for research through surveys and data analysis to better quantify the capabilities and capacity of the national system. This includes measuring state and local activities such as surveillance, regulatory actions, and outbreak or emergency response work, as well as documenting infrastructure realities like staffing and resources, funding streams, legal authorities, IT support, licensing protocols, reliance on general funds, and training requirements. The recipient should plan to conduct at least one national survey per budget period and use the results to inform a more effective integrated system. Another expected output in this area is the development of task-oriented guidelines that manufactured food programs can adopt or reference to address common implementation issues.

Partnership-building is explicitly required. In support of FSMA, the awardee is expected to work with FDA to establish, participate in, and promote operational partnerships that accelerate integration. Examples cited include coordination with other national alliances and associations (such as the Seafood HACCP Alliance and the Preventive Controls Alliance), along with PFP and Food Protection Task Forces. The award also includes a subaward-like financial support function: providing funding to manufactured food regulatory programs so they can develop, host, or attend trainings, meetings, conferences, and events that advance an integrated food safety system. However, this is not open-ended; the opportunity specifies that an application and approval process for subawards must be conducted in collaboration with and approved by FDA, reinforcing the cooperative nature of the agreement and FDA’s ongoing involvement in key funding decisions.

Finally, the opportunity extends beyond immediate regulatory operations into workforce development. The recipient is expected to support outreach to colleges and universities to promote career paths and experiential learning in regulatory affairs and sciences, and to support advanced training or fellowship programs that provide hands-on learning, applied research, and mentorship in manufactured food regulation. Across all activities, the grant requires a system for continuous improvement: the awardee should actively solicit feedback from state manufactured food programs about what is working and what is not, then use that input to adjust future activities. Applicants are also encouraged to propose additional activities aligned with the cooperative agreement’s goals, and the application is expected to include baseline data, targets, performance measures, and suggested reporting criteria for each major activity so progress can be tracked and continuation funding decisions can be made based on clear evidence of performance.

• 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 "Alliance to Support Integrated Public Health System Activities (U2F) Clinical Trials 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 Feb 18, 2021.
• Applicants must submit their applications by Apr 23, 2021. (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 $3,000,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• 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.

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