Opportunity Information: Apply for RFA FD 24 012
The National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) is an FDA cooperative agreement (Funding Opportunity Number RFA FD 24 012; CFDA 93.103) focused on strengthening how produce safety regulation is carried out across the United States in a more uniform, modern, and effective way. The work centers on helping state and territorial produce safety regulatory programs implement and align with the FDA regulation called "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption," more commonly known as the Produce Safety Rule. In practical terms, the opportunity is about building a national support structure that makes it easier for state and territorial agencies to apply the Produce Safety Rule consistently, share solutions, and improve regulatory capacity so that produce safety expectations are clearer and more consistent from one jurisdiction to the next.
The cooperative agreement model signals that this is not a hands-off grant where the awardee simply carries out an independent project. Instead, the selected recipient is expected to work in close partnership with FDA to identify, create, share, and leverage resources and information that support implementation of produce safety regulatory programs nationwide. The emphasis is on consistency and effectiveness: developing and improving tools, approaches, and shared resources that help programs become more aligned with the Produce Safety Rule and stronger in their ability to carry out their responsibilities. The opportunity frames this as building a "nationally consistent system of support," meaning the deliverables should be broadly usable by state and territorial programs rather than tailored to a single locality.
Eligibility is intentionally limited. The announcement explains that applicants must represent state departments of agriculture and/or state departments of health as a primary purpose, reflecting the unique role these entities play in day-to-day produce safety oversight and in federal-state collaboration. The notice also references Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) in describing eligibility related to state, local, territorial, and tribal agencies and nonprofit training entities that collaborate with one or more institutions of higher education. However, the competition is specifically limited to nonprofit national food safety training associations or organizations that collaborate with one or more institutions of higher education, reflecting FDA's intent to fund a national-level group capable of coordinating training and support across jurisdictions.
A notable operational requirement is information sharing. 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. The notice clarifies that any information sharing is limited to pre-decisional information and can only be used for the purposes outlined in the award, which is important for applicants to plan governance, confidentiality practices, and internal controls.
Foreign participation is not allowed. Non-U.S. entities are ineligible, non-U.S. components of U.S. organizations are ineligible, and foreign components (as defined in the HHS Grants Policy Statement) are not permitted. This keeps the work fully domestic and aligned with U.S. federal and state regulatory implementation.
From an administrative and funding standpoint, the opportunity is categorized as a discretionary award using a cooperative agreement instrument type, within the activity area of agriculture, consumer protection, and food and nutrition. FDA expects to make a single award (Expected Awards: 1), with an award ceiling of $1,500,000. The opportunity was created on 2023-12-21, with an original application closing date of 2024-06-10. Overall, the grant is designed to fund one national hub organization that can coordinate resources, training-related support, and information exchange to help state and territorial produce safety regulators apply the Produce Safety Rule more consistently and effectively nationwide.Apply for RFA FD 24 012
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) -Cooperative Agreements" 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 2023-12-21.
- Applicants must submit their applications by 2024-06-10. (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 $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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Applicants who have applied for this opportunity (RFA FD 24 012) also looked into and applied for these:
| Funding Opportunity |
|---|
| Produce Safety Alliance-U01 Clinical Trials Not Allowed Apply for RFA FD 24 018 Funding Number: RFA FD 24 018 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed Apply for RFA FD 24 022 Funding Number: RFA FD 24 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed Apply for RFA FD 24 020 Funding Number: RFA FD 24 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026 Funding Number: RFA FD 24 026 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023 Funding Number: RFA FD 24 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025 Funding Number: RFA FD 24 025 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029 Funding Number: RFA FD 24 029 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027 Funding Number: RFA FD 24 027 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $20,000,000 |
| Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007 Funding Number: RFA FD 24 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006 Funding Number: RFA FD 24 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008 Funding Number: RFA FD 24 008 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005 Funding Number: RFA FD 24 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
| 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 |
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