Opportunity Information: Apply for RFA FD 24 039
The Food and Drug Administration is offering a cooperative agreement opportunity called "Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19), Clinical Trials Not Allowed" (RFA-FD-24-039; CFDA 93.103). The overall purpose is to strengthen a nationally Integrated Food Safety System (IFSS) by helping state, tribal, and territorial manufactured food regulatory programs build, improve, and sustain the core infrastructure needed to run consistent, high-quality oversight of manufactured food operations. The funding is designed to support work aligned with the Manufactured Food Regulatory Program Standards (MFRPS) and to expand integration and collaboration across partners involved in human and animal food protection.
At the center of the NOFO is support for MFRPS development or maintenance. The MFRPS are FDA program standards meant to create a uniform, measurable framework for state manufactured food regulatory programs so they can assess performance, close gaps, and continuously improve. The emphasis is on building a strong regulatory foundation that supports mutual reliance between federal and state programs, so that oversight efforts are more aligned, less duplicative, and more effective. In practical terms, the funding is intended to help programs reach and sustain conformance with the most current version of the MFRPS, which ultimately helps direct inspection and regulatory resources toward the greatest foodborne illness hazards in facilities that manufacture, process, pack, or hold food.
A second major component is the Food Protection Task Force (FPTF) option. Under this track, funding supports establishing or strengthening a statewide task force with broad membership that reflects key stakeholders. The goal is to improve integration of an efficient statewide human and animal food protection system tailored to the needs of the state or region. Activities described include building networks of subject matter experts, creating education and training opportunities, developing resources that can be replicated by other jurisdictions, and improving coordination and communication among federal, state, local, tribal, and territorial agencies as well as industry, academia, public health partners, and consumers. The NOFO also highlights emergency readiness as a benefit of a strong FPTF, particularly improving surveillance, response, and post-response functions by strengthening relationships and communication channels before a food incident occurs.
The NOFO also includes a dietary supplements option focused on helping states build their own regulatory framework and program capacity for dietary supplement oversight. The stated objective is to advance adoption and implementation of the Current Good Manufacturing Practices (cGMPs) for dietary supplements under 21 CFR Part 111. Funding in this area is aimed at training and program development, supporting states as they expand knowledge, procedures, and regulatory capabilities connected to dietary supplement manufacturing and compliance expectations.
In addition, the opportunity provides for special projects meant to support innovation and deeper integration within the IFSS using the MFRPS framework. This track is intended to be flexible so it can address emerging food safety priorities that arise during the project period. A key expectation is that recipients will share deliverables and resources developed through these special projects with other programs, reinforcing the national integration goal and allowing successful tools or approaches to be reused across jurisdictions.
Eligibility is intentionally limited. Only state, tribal, and territorial manufactured food regulatory programs are eligible, and the competition is restricted to programs that already have FDA food safety inspection contracts or that meet eligibility requirements and agree to enter into a food safety inspection contract with FDA as soon as possible. The rationale is that foundational work performed under existing FDA inspection contracts is considered necessary to achieve the larger IFSS improvements targeted by this funding model. Applicants must also have a long-term food nonpublic information sharing agreement with FDA under 20 CFR 20.88, or agree to put that agreement in place by the end of grant year one (by June 30, 2025). Applicants are grouped into one of two main funding tracks, MFRPS Development or MFRPS Maintenance, and within those tracks they may pursue additional funding options (such as FPTF, dietary supplements, or special projects) if they meet the specific eligibility criteria for those options. The NOFO encourages applicants to request an amount and project duration that fits their jurisdiction's actual needs, and it indicates that tiered funding levels apply (with tiers explained in the award information section of the NOFO).
Key administrative details included in the listing are that this is a discretionary cooperative agreement (meaning FDA expects substantial involvement and collaboration during the project), clinical trials are not allowed, and the application closing date listed is April 1, 2024. The award ceiling is $340,000, and FDA anticipates making about four awards under this announcement.Apply for RFA FD 24 039
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) 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 2024-02-01.
- Applicants must submit their applications by 2024-04-01. (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 $340,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: State governments, Native American tribal governments (Federally recognized), Others.
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Frequently Asked Questions (FAQs)
What is this funding opportunity called?
The opportunity is titled "Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19), Clinical Trials Not Allowed" (RFA-FD-24-039; CFDA 93.103).
Which federal agency is offering this cooperative agreement?
The Food and Drug Administration (FDA) is offering this cooperative agreement opportunity.
What is the overall purpose of this funding?
The purpose is to strengthen a nationally Integrated Food Safety System (IFSS) by helping state, tribal, and territorial manufactured food regulatory programs build, improve, and sustain the core infrastructure needed to run consistent, high-quality oversight of manufactured food operations.
What types of programs is the funding designed to support?
The funding is designed to support state, tribal, and territorial manufactured food regulatory programs, with work aligned to the Manufactured Food Regulatory Program Standards (MFRPS) and with an emphasis on expanding integration and collaboration across human and animal food protection partners.
What are the Manufactured Food Regulatory Program Standards (MFRPS)?
The MFRPS are FDA program standards that provide a uniform, measurable framework for state manufactured food regulatory programs to assess performance, identify gaps, and continuously improve.
What is the central focus of the NOFO?
The central focus is support for MFRPS development or MFRPS maintenance, aimed at helping programs reach and sustain conformance with the most current version of the MFRPS.
Why does FDA emphasize MFRPS conformance?
The NOFO emphasizes MFRPS conformance to build a strong regulatory foundation that supports mutual reliance between federal and state programs, improves alignment, reduces duplication, and helps focus inspection and regulatory resources on the greatest foodborne illness hazards in manufactured food facilities.
What types of facilities are the oversight efforts meant to address?
The NOFO discusses oversight of facilities that manufacture, process, pack, or hold food.
What is meant by an "Integrated Food Safety System (IFSS)" in this opportunity?
In this opportunity, IFSS refers to a nationally integrated approach where federal and state (and other) partners work in a more aligned and collaborative way to improve human and animal food protection and reduce duplicative oversight.
What is the Food Protection Task Force (FPTF) option?
The FPTF option is an additional funding track/component that supports establishing or strengthening a statewide task force with broad membership representing key stakeholders to improve integration of an efficient statewide human and animal food protection system tailored to the needs of the state or region.
What kinds of activities can the Food Protection Task Force (FPTF) support?
Activities described include building networks of subject matter experts, creating education and training opportunities, developing resources that can be replicated by other jurisdictions, and improving coordination and communication among federal, state, local, tribal, and territorial agencies as well as industry, academia, public health partners, and consumers.
How does the NOFO connect the FPTF option to emergency readiness?
The NOFO highlights that a strong FPTF can improve emergency readiness by strengthening relationships and communication channels before an incident occurs, which supports better surveillance, response, and post-response functions during a food incident.
Is there an option related to dietary supplements?
Yes. The NOFO includes a dietary supplements option focused on helping states build their own regulatory framework and program capacity for dietary supplement oversight.
What is the objective of the dietary supplements option?
The stated objective is to advance adoption and implementation of the Current Good Manufacturing Practices (cGMPs) for dietary supplements under 21 CFR Part 111.
What kinds of activities are supported under the dietary supplements option?
Funding in this area is aimed at training and program development, supporting states as they expand knowledge, procedures, and regulatory capabilities related to dietary supplement manufacturing and compliance expectations.
What are "special projects" under this NOFO?
Special projects are included to support innovation and deeper integration within the IFSS using the MFRPS framework. This track is intended to be flexible so it can address emerging food safety priorities that arise during the project period.
Is there an expectation to share special project results?
Yes. A key expectation is that recipients will share deliverables and resources developed through special projects with other programs so successful tools or approaches can be reused across jurisdictions and support national integration goals.
Who is eligible to apply?
Eligibility is limited to state, tribal, and territorial manufactured food regulatory programs.
Are there additional eligibility restrictions beyond being a state, tribal, or territorial manufactured food regulatory program?
Yes. The competition is restricted to programs that already have FDA food safety inspection contracts or that meet eligibility requirements and agree to enter into a food safety inspection contract with FDA as soon as possible.
Why does the NOFO require or prioritize FDA food safety inspection contracts?
The rationale provided is that foundational work performed under existing FDA inspection contracts is considered necessary to achieve the larger IFSS improvements targeted by this flexible funding model.
Is a nonpublic information sharing agreement with FDA required?
Yes. Applicants must have a long-term food nonpublic information sharing agreement with FDA under 20 CFR 20.88, or they must agree to put that agreement in place by the end of grant year one (by June 30, 2025).
What is the deadline for putting the nonpublic information sharing agreement in place if the applicant does not already have it?
The NOFO states the agreement must be in place by the end of grant year one, specifically by June 30, 2025.
What are the main funding tracks described?
Applicants are grouped into one of two main funding tracks: MFRPS Development or MFRPS Maintenance.
Can applicants pursue additional options beyond the main MFRPS track?
Yes. Within the main tracks, applicants may pursue additional funding options such as the Food Protection Task Force (FPTF), dietary supplements, or special projects if they meet the specific eligibility criteria for those options.
How should applicants decide the amount of funding and project length to request?
The NOFO encourages applicants to request an amount and project duration that fits their jurisdiction's actual needs.
Does the NOFO mention different funding levels?
Yes. The NOFO indicates that tiered funding levels apply, with tiers explained in the award information section of the NOFO.
What type of award mechanism is being used?
This is a discretionary cooperative agreement.
What does "cooperative agreement" imply for how the project will be run?
The NOFO notes that a cooperative agreement means FDA expects substantial involvement and collaboration during the project.
Are clinical trials allowed under this opportunity?
No. Clinical trials are not allowed.
What is the application closing date listed in the NOFO?
The listed application closing date is April 1, 2024.
What is the maximum (ceiling) award amount?
The award ceiling is $340,000.
How many awards does FDA anticipate making under this announcement?
FDA anticipates making about four awards under this announcement.
How does this opportunity support mutual reliance between federal and state programs?
By supporting programs in reaching and sustaining conformance with the MFRPS, the NOFO aims to create a consistent regulatory foundation that helps federal and state oversight efforts become more aligned, less duplicative, and more effective.
How does this opportunity relate to human and animal food protection?
The NOFO repeatedly emphasizes integration and collaboration across partners involved in both human and animal food protection, including through the FPTF option and broader IFSS goals.
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| Funding Opportunity |
|---|
| Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030 Funding Number: RFA FD 24 030 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| 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 Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| 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 |
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