Opportunity Information: Apply for RFA FD 20 004
This funding opportunity is a cooperative agreement from the U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), aimed at improving food safety capacity and Food Safety Modernization Act (FSMA) readiness in Native American tribal communities. The project is designed to support an organization that already has strong, active working relationships with federally recognized tribes and that can deliver science-based food safety training and technical support in ways that fit tribal cultures, practices, and local realities. The emphasis is on agricultural production (especially produce) and human food manufacturing or processing, including operations that handle foods covered by FSMA rules even if, because of size or sales channels, they may not technically fall under FSMA regulatory coverage today.
At its core, the program’s goal is to expand practical training, education, outreach, and technical assistance for tribal produce growers, packers, and food processors. The FDA is especially focused on helping tribal stakeholders understand and implement the FSMA Produce Safety Rule and the Preventive Controls for Human Food rule, while still encouraging applicants to account for the full range of FSMA regulations as they may apply across different tribal operations. The opportunity also recognizes that some tribal farms and businesses may not be required to comply right now, but may want to adopt FSMA-aligned practices anyway due to marketplace demands, buyer requirements, business growth plans, or other economic incentives. In other words, the target audience includes both currently covered entities and those preparing to meet customer expectations or future regulatory thresholds.
A key expectation is that the funded entity will not work in isolation. Applicants are expected to build real collaboration across national and regional tribal stakeholder leadership, tribal organizations, tribal colleges and universities (and their national networks), land-grant cooperative extension programs, and other partners involved in food safety efforts. Coordination with established FSMA education groups is also encouraged, including the Produce Safety Alliance (PSA), the Food Safety Preventive Controls Alliance (FSPCA), and the Sprout Safety Alliance where relevant. The program strongly emphasizes cooperation with FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and other FDA offices, as well as coordination with USDA and USDA-NIFA Food Safety Outreach Program (FSOP) Regional Centers. Participation in regional and national FSMA-related meetings, such as the FDA-USDA FSMA Collaborative Training Forum, is considered part of the work, reflecting the broader goal of strengthening an integrated national food safety system that includes tribal partners.
In terms of what the project should actually do, the cooperative agreement is meant to (1) deliver training and outreach; (2) identify and address training gaps, which may include developing new materials or adapting existing curricula; and (3) help tribal stakeholders connect to appropriate technical assistance resources that can support implementation on the ground. The FDA anticipates that standardized, nationally recognized curricula (like PSA and FSPCA materials) will serve as a starting point, but that the recipient will customize or modify these resources to reflect regional conditions and culturally specific tribal farming and processing practices. Because FDA wants consistency and credibility in training, the agency also intends to work with the recipient so that any alternate or adapted curricula are recognized by FDA.
Another major component is evaluation. Beyond delivering training, the awardee is expected to conduct research-oriented program evaluation to measure whether the education, outreach, and technical assistance actually reduce knowledge gaps and improve readiness or compliance. This includes collecting and analyzing data to assess program impact, and coordinating with FDA, USDA, and other educational partners as needed to complete a credible evaluation approach. The logic behind this requirement is practical: the agency wants evidence about what works, where barriers remain, and what kinds of culturally tailored support best improve food safety outcomes in tribal settings.
From a public health and systems perspective, FDA frames this investment as a way to increase adoption of prevention-based food safety practices, improve consistency of FSMA implementation across the country, and reduce foodborne illness risks. The program also aims to build longer-term capacity and infrastructure in tribal communities by improving access to affordable, high-quality training and by leveraging the expertise of tribal regulatory staff and partners. Overall, it is a single expected award cooperative agreement (U01 mechanism) with an award ceiling of $1,000,000, listed as “Clinical Trial Not Allowed,” and it is open to a wide range of applicants, including tribal governments and organizations, universities, nonprofits, for-profits, small businesses, and individuals, as long as they can demonstrate the relationships and culturally grounded food safety training capability the program is seeking.Apply for RFA FD 20 004
- 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 "Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial 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 Nov 27, 2019.
- Applicants must submit their applications by Jan 28, 2020. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, Individuals, For profit organizations other than small businesses, Small businesses.
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| Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed Apply for RFA FD 20 019 Funding Number: RFA FD 20 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed Apply for RFA FD 20 018 Funding Number: RFA FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
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| Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional Apply for RFA FD 20 007 Funding Number: RFA FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Apply for PAR 20 083 Funding Number: PAR 20 083 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed Apply for RFA FD 20 020 Funding Number: RFA FD 20 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional) Apply for RFA FD 20 021 Funding Number: RFA FD 20 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Optional) Apply for RFA FD 20 009 Funding Number: RFA FD 20 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed Apply for RFA FD 20 013 Funding Number: RFA FD 20 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional Apply for RFA FD 20 025 Funding Number: RFA FD 20 025 Agency: Department of Health and Human Services, 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) (U18) Clinical Trials Not Allowed Apply for RFA FD 20 012 Funding Number: RFA FD 20 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $70,000 |
| Cooperative Agreement for Data Collection on Antimicrobial Use in Dogs and Cats (UO1) Clinical Trials Not Allowed Apply for RFA FD 20 026 Funding Number: RFA FD 20 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Apply for PAR 20 105 Funding Number: PAR 20 105 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed Apply for RFA FD 20 027 Funding Number: RFA FD 20 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $8,000,000 |
| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Apply for PAR 20 124 Funding Number: PAR 20 124 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 031 Funding Number: RFA FD 20 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Apply for PAR 20 132 Funding Number: PAR 20 132 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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