Opportunity Information: Apply for RFA FD 24 034

The FDA funding opportunity titled "Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade A Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed" (Funding Opportunity Number RFA-FD-24-034) is a discretionary cooperative agreement designed to strengthen the national food safety system by supporting coordinated, nationwide work that states and territories rely on to run consistent, high-quality food regulatory programs. It sits in the Agriculture, Consumer Protection, Food and Nutrition activity category (CFDA 93.103) and is structured as a cooperative agreement, meaning the FDA expects to have an active partnership role with the awardee rather than simply providing a pass-through grant with minimal federal involvement.

The opportunity has two major, connected goals. First, it aims to drive long-term improvements to the broader national food safety system by strengthening collaboration across agencies, enhancing state regulatory and surveillance programs for manufactured foods, supporting applied research, and promoting adoption and use of the Manufactured Food Regulatory Program Standards (MFRPS). In practice, this portion of the work is about helping state programs build capacity and consistency so manufactured food oversight is more uniform and effective nationwide, with better prevention, detection, and response to food safety problems. Second, it continues the development, implementation, management, and ongoing support of a funding system that state and territorial agencies can tap into when they have primary responsibility for regulating Grade A milk and/or molluscan shellfish under the National Shellfish Sanitation Program (NSSP). The key point is that the prime recipient is expected to operate or support a sub-award structure that distributes funds to the state and territorial agencies that do the frontline work, so they can address concrete needs such as staff training, equipment purchases, and other priorities required to implement and maintain strong Grade A Milk Safety and NSSP regulatory programs within their jurisdictions.

Eligibility is intentionally narrow and tailored to national-scale organizations that already function as hubs for state and territorial food regulatory programs. The applicant must be a nonprofit organization (either with or without 501(c)(3) status, but in either case not an institution of higher education) and must be a nonprofit food safety training association or similar organization that collaborates with one or more institutions of higher education. Its membership must include, though not necessarily be limited to, state or territorial personnel working in manufactured food regulatory programs, the Grade A Milk Safety program, and/or the National Shellfish Sanitation regulatory program. Beyond that, only national associations or organizations whose primary purpose is representing state or territorial food regulatory programs are eligible to apply. The stated rationale for limiting competition to these national entities is that they already have the relationships, communication channels, and credibility needed to promote and implement the cooperative agreement objectives at scale; they share FDA goals around advancing food safety and improving public health outcomes; and they can rapidly disseminate information and standard practices through national and regional meetings, websites, listservs, and standing committees that can support broad implementation by sub-awardees.

A critical compliance condition is information sharing with FDA. Applicant associations must already hold an information sharing agreement with FDA under 21 CFR 20.88(e), or they must be able to secure one before the award start date. The information sharing contemplated here is limited to pre-decisional information and may only be used for the purposes described in the award, which signals that the awardee may be involved in coordination activities where early, non-public regulatory or program information is discussed to align efforts across the national system.

The application must also include specific assurances and planning details required under 21 USC 399(a)(1)(B) and (2). Applicants must provide (A) an assurance that they have developed plans to engage in the types of activities described throughout the funding announcement, (B) a description of the activities that will be funded by the grant, (C) an itemized budget describing how grant funds will be spent, (D) a description of how the grant-supported activities will be monitored, and (E) an agreement to report information the Secretary requires so FDA can conduct evaluations as required by 21 USC 399(f)(1). Collectively, these requirements emphasize that FDA is looking for a mature, accountable national partner with clear plans, transparent financial management, and a strong performance monitoring and reporting approach that can support evaluation of outcomes.

The award parameters reflect a single, large national cooperative agreement rather than multiple smaller awards. The expected number of awards is one, with an award ceiling of $6,000,000. The original closing date listed for applications was May 6, 2024, and the funding opportunity was created March 4, 2024. Clinical trials are explicitly not allowed, which signals the work is intended to focus on systems building, program implementation, training, standards adoption, surveillance and regulatory capacity improvements, and related research or evaluation activities that do not involve clinical trial designs.

Overall, this opportunity is aimed at funding a national coordinating organization that can serve as an operational backbone for Integrated Food Safety System activities, while also running or supporting a sub-award funding mechanism that directly helps state and territorial programs improve the day-to-day regulatory infrastructure behind manufactured food oversight, Grade A milk safety, and shellfish sanitation. The FDA is essentially investing in a single national partner that can coordinate, standardize, communicate, and distribute resources efficiently across jurisdictions to improve consistency, readiness, and public health protection nationwide.

  • The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) 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 2024-03-04.
  • Applicants must submit their applications by 2024-05-06. (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.
  • 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, Others.
Apply for RFA FD 24 034

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Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040

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Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024

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Minor Use Minor Species Development of Drugs (R01) Apply for PAR 24 216

Funding Number: PAR 24 216
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Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U18) - Clinical Trials Not Allowed Apply for RFA FD 24 017

Funding Number: RFA FD 24 017
Agency: Food and Drug Administration
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Animal and Veterinary Innovation Centers (U18) Apply for PAR 24 251

Funding Number: PAR 24 251
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Single Source Cooperative Agreement to Support HPAI H5N1 Research at Cornell University (U18) - Clinical Trails Not Allowed Apply for RFA FD 24 042

Funding Number: RFA FD 24 042
Agency: Food and Drug Administration
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Funding Number: RFA FD 25 001
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Laboratory Flexible Funding Model (LFFM) Apply for RFA FD 25 007

Funding Number: RFA FD 25 007
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A Research Study of Contaminants in School Meals (U18) Apply for RFA FD 25 024

Funding Number: RFA FD 25 024
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Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed Apply for PAR 25 003

Funding Number: PAR 25 003
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Food Safety Capacity and Infrastructure Building (U2F) Apply for RFA FD 25 019

Funding Number: RFA FD 25 019
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