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.Apply for RFA FD 24 034
- 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.
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Frequently Asked Questions (FAQs)
1) What is the title and funding opportunity number for this grant?
The opportunity is 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." The Funding Opportunity Number is RFA-FD-24-034.
2) What type of award is this?
This is a discretionary cooperative agreement (U01). A cooperative agreement means FDA expects to be actively involved as a partner in the work, rather than providing funding with minimal federal involvement.
3) What is the primary purpose of this funding opportunity?
The purpose is to strengthen the national food safety system by supporting coordinated, nationwide work that state and territorial agencies rely on to operate consistent, high-quality food regulatory programs. It is intended to fund a national coordinating organization that can drive collaboration, standardization, communication, and resource distribution across jurisdictions.
4) What activity category and CFDA number does this opportunity fall under?
This opportunity is in the Agriculture, Consumer Protection, Food and Nutrition activity category and is listed under CFDA 93.103.
5) What are the major goals of the project?
The opportunity has two connected goals:
- Strengthen long-term national food safety system performance by improving 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).
- Continue development, implementation, management, and ongoing support of a funding system that state and territorial agencies can use when they have primary responsibility for regulating Grade A milk and/or molluscan shellfish under the National Shellfish Sanitation Program (NSSP).
6) What kinds of activities are expected under the manufactured foods and IFSS portion?
Expected activities include strengthening collaboration across agencies, improving state regulatory and surveillance programs for manufactured foods, supporting applied research, and promoting adoption and use of MFRPS. The emphasis is on building capacity and consistency so oversight of manufactured foods is more uniform and effective nationwide, improving prevention, detection, and response to food safety issues.
7) What is the Grade A Milk Safety and NSSP funding system expected to do?
The funded organization is expected to continue developing and supporting a funding system that state and territorial agencies can tap into for Grade A milk and/or molluscan shellfish regulatory responsibilities under NSSP. A key feature is operating or supporting a sub-award structure that distributes funding to frontline state and territorial agencies to address concrete program needs.
8) What are examples of needs that sub-awards may support?
Examples mentioned include staff training, equipment purchases, and other priorities required to implement and maintain strong Grade A Milk Safety and NSSP regulatory programs within a state or territory.
9) Who is eligible to apply?
Eligibility is intentionally narrow. The applicant must be:
- A nonprofit organization (with or without 501(c)(3) status), and not an institution of higher education.
- A nonprofit food safety training association or similar organization that collaborates with one or more institutions of higher education.
- An organization whose membership includes (but is not necessarily limited to) state or territorial personnel working in manufactured food regulatory programs, the Grade A Milk Safety program, and/or the NSSP regulatory program.
- A national association or organization whose primary purpose is representing state or territorial food regulatory programs.
10) Are universities or institutions of higher education eligible as the primary applicant?
No. The applicant must be a nonprofit organization and is explicitly not allowed to be an institution of higher education. However, the eligible nonprofit is expected to collaborate with one or more institutions of higher education.
11) Why is eligibility limited to certain national organizations?
The stated rationale is that these national entities already have the relationships, communication channels, and credibility needed to implement the objectives at scale. They share FDA goals to advance food safety and public health outcomes and can rapidly disseminate information and standard practices through established national and regional meetings, websites, listservs, and standing committees.
12) What does it mean that FDA will have an "active partnership role"?
Because this is a cooperative agreement, FDA expects involvement beyond simple grant oversight. The awardee should be prepared to coordinate closely with FDA on project activities tied to national food safety system strengthening and the operation or support of the sub-award funding system for Grade A milk and shellfish sanitation work.
13) Is an FDA information sharing agreement required?
Yes. Applicant associations must already have an information sharing agreement with FDA under 21 CFR 20.88(e) or be able to secure one before the award start date.
14) What kind of information sharing is contemplated under 21 CFR 20.88(e)?
The information sharing described is limited to pre-decisional information, and it may only be used for the purposes described in the award. This indicates the awardee may participate in coordination where early, non-public regulatory or program information is discussed to align efforts across the national system.
15) What application assurances and planning details are required by statute?
The application must include assurances and planning details required under 21 USC 399(a)(1)(B) and (2), including:
- An assurance that the applicant has developed plans to engage in the types of activities described in the funding announcement.
- A description of the activities that will be funded by the grant.
- An itemized budget describing how grant funds will be spent.
- A description of how the grant-supported activities will be monitored.
- An agreement to report information the Secretary requires so FDA can conduct evaluations as required by 21 USC 399(f)(1).
16) What do the statutory requirements suggest FDA is looking for in an awardee?
They suggest FDA is looking for a mature national partner with clear project plans, transparent financial management, a strong monitoring approach, and the ability to report performance information that supports FDA evaluation of outcomes.
17) How many awards does FDA expect to make?
FDA expects to make one award.
18) What is the maximum funding amount (award ceiling)?
The award ceiling is $6,000,000.
19) When was the opportunity created and what was the original application closing date?
The opportunity was created March 4, 2024. The original closing date listed for applications was May 6, 2024.
20) Are clinical trials allowed under this funding opportunity?
No. Clinical trials are explicitly not allowed. 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.
21) What role do sub-awards play in this cooperative agreement?
A central expectation is that the prime recipient will operate or support a sub-award structure that distributes funds to state and territorial agencies with frontline regulatory responsibility. This sub-award mechanism is designed to help jurisdictions address practical needs to implement and maintain Grade A Milk Safety and NSSP regulatory programs.
22) Which state and territorial programs are specifically emphasized?
The opportunity emphasizes programs involved in manufactured food regulatory oversight, Grade A Milk Safety, and the National Shellfish Sanitation Program (NSSP), including molluscan shellfish sanitation responsibilities.
23) How does this opportunity relate to the Manufactured Food Regulatory Program Standards (MFRPS)?
One of the stated goals is to promote adoption and use of MFRPS as part of strengthening state regulatory and surveillance programs for manufactured foods and improving national consistency and effectiveness.
24) What is the overall intended impact of this award?
The intended impact is improved consistency, readiness, and public health protection nationwide by funding a single national organization that can coordinate IFSS activities, standardize and communicate best practices, strengthen state program capacity, and distribute resources efficiently across jurisdictions for manufactured foods, Grade A milk safety, and shellfish sanitation.
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| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| 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 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Apply for PAR 19 306 Funding Number: PAR 19 306 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed] Apply for RFA FD 22 021 Funding Number: RFA FD 22 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 24 216 Funding Number: PAR 24 216 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| 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 Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Animal and Veterinary Innovation Centers (U18) Apply for PAR 24 251 Funding Number: PAR 24 251 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,250,000 |
| 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 Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,150,000 |
| Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required Apply for RFA FD 25 001 Funding Number: RFA FD 25 001 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $650,000 |
| Laboratory Flexible Funding Model (LFFM) Apply for RFA FD 25 007 Funding Number: RFA FD 25 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| A Research Study of Contaminants in School Meals (U18) Apply for RFA FD 25 024 Funding Number: RFA FD 25 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| 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 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Food Safety Capacity and Infrastructure Building (U2F) Apply for RFA FD 25 019 Funding Number: RFA FD 25 019 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Conformance with the Egg Regulatory Program Standards Apply for RFA FD 25 021 Funding Number: RFA FD 25 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $47,000 |
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