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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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is a cooperative agreement from the U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS). It is designed to strengthen food safety capacity and improve Food Safety Modernization Act (FSMA) readiness in Native American tribal communities.
What is the main purpose of the project?
The main purpose is to expand practical, science-based training, education, outreach, and technical assistance for tribal stakeholders involved in agricultural production (especially produce) and human food manufacturing or processing. The goal is to increase adoption of prevention-based food safety practices and reduce foodborne illness risks, while building longer-term food safety capacity in tribal communities.
What type of award is it?
It is a cooperative agreement using the U01 mechanism. A cooperative agreement typically involves substantial involvement from the funding agency (here, FDA) in the funded work, including coordination on training approaches and recognition of adapted curricula.
How many awards does FDA expect to make?
The opportunity describes a single expected award.
What is the maximum funding amount?
The award ceiling is $1,000,000.
Are clinical trials allowed under this award?
No. The listing states “Clinical Trial Not Allowed.”
Who is the target audience for the training and assistance?
The target audience includes tribal produce growers, packers, and food processors, as well as other tribal stakeholders who need food safety training and implementation support in tribal settings.
Which food sectors does the program emphasize?
The program emphasizes agricultural production (especially produce) and human food manufacturing or processing, including operations that handle foods addressed by FSMA rules.
Is the program only for operations currently covered by FSMA regulations?
No. The program also includes tribal farms and businesses that may not be required to comply with FSMA today (for example, due to size or sales channels) but want to adopt FSMA-aligned practices due to buyer requirements, marketplace expectations, growth plans, or other economic incentives.
Which FSMA rules are especially emphasized?
FDA is especially focused on helping tribal stakeholders understand and implement the FSMA Produce Safety Rule and the Preventive Controls for Human Food rule. Applicants are also encouraged to consider the full range of FSMA regulations as they may apply across different tribal operations.
What are the core activities the funded project is expected to carry out?
The cooperative agreement is intended to support three core activity areas: (1) delivering training and outreach; (2) identifying and addressing training gaps (including developing new materials or adapting existing curricula); and (3) helping tribal stakeholders connect to appropriate technical assistance resources to support on-the-ground implementation.
What does “science-based” training mean in this context?
It means the training and outreach are expected to be grounded in established food safety principles and credible, nationally recognized approaches (such as standardized FSMA training curricula), while still being adapted so they work in real-world tribal settings.
Does the project need to tailor training for tribal cultures and practices?
Yes. A central expectation is that training and technical support will be delivered in ways that fit tribal cultures, practices, and local realities, including regional conditions and culturally specific farming and processing practices.
Are applicants expected to use existing national training curricula?
Yes. FDA anticipates that standardized, nationally recognized curricula will serve as a starting point, including materials from groups like the Produce Safety Alliance (PSA) and the Food Safety Preventive Controls Alliance (FSPCA), and the Sprout Safety Alliance where relevant.
Can training curricula be adapted or customized?
Yes. The recipient is expected to customize or modify training resources to reflect regional conditions and culturally specific tribal practices. FDA also intends to work with the recipient so adapted or alternate curricula are recognized by FDA, supporting consistency and credibility.
What partnerships or collaborations are expected?
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.
Are applicants encouraged to coordinate with established FSMA education groups?
Yes. Coordination is encouraged with established FSMA education and training organizations such as the Produce Safety Alliance (PSA), the Food Safety Preventive Controls Alliance (FSPCA), and the Sprout Safety Alliance where relevant.
What role does FDA play during the project?
The program strongly emphasizes cooperation with FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and other FDA offices. Because this is a cooperative agreement, FDA expects close coordination, including around training consistency and recognition of adapted curricula.
Is coordination with USDA mentioned?
Yes. The opportunity calls for coordination with USDA and the USDA-NIFA Food Safety Outreach Program (FSOP) Regional Centers.
Are meetings and forums part of the expected work?
Yes. Participation in regional and national FSMA-related meetings is considered part of the work, including meetings such as the FDA-USDA FSMA Collaborative Training Forum.
What does the opportunity mean by strengthening an “integrated national food safety system”?
It refers to improving consistency and coordination of FSMA implementation across the country by linking tribal partners with FDA, USDA, and established education and outreach networks, so tribal communities are included as full partners in national food safety capacity building.
Is evaluation required, or is this only a training project?
Evaluation is a major requirement. Beyond delivering training and technical assistance, the awardee is expected to conduct research-oriented program evaluation to assess whether the work reduces knowledge gaps and improves readiness or compliance.
What kinds of evaluation activities are anticipated?
The opportunity anticipates collecting and analyzing data to measure program impact and to identify what works, what barriers remain, and what types of culturally tailored support best improve food safety outcomes in tribal settings. Coordination with FDA, USDA, and other educational partners may be needed to support a credible evaluation approach.
What outcomes is FDA trying to achieve through this investment?
FDA frames the outcomes as improved adoption of prevention-based food safety practices, improved consistency of FSMA implementation, reduced foodborne illness risks, and stronger long-term capacity and infrastructure in tribal communities through access to affordable, high-quality training and leveraged expertise from tribal regulatory staff and partners.
Who is eligible to apply?
The opportunity is open to a wide range of applicants, including tribal governments and organizations, universities, nonprofits, for-profits, small businesses, and individuals.
Is eligibility based only on organizational type?
No. While many types of entities may apply, applicants are expected to demonstrate strong, active working relationships with federally recognized tribes and the ability to deliver culturally grounded, science-based food safety training and technical support.
Does the funded organization need existing relationships with tribes?
Yes. The project is designed to support an organization that already has strong, active working relationships with federally recognized tribes.
Does the project focus only on education, or also on implementation support?
It includes both. In addition to training and outreach, the project is expected to connect tribal stakeholders to technical assistance resources that support implementation on the ground.
Does the opportunity mention addressing training gaps?
Yes. Identifying and addressing training gaps is explicitly included, and this may involve developing new materials or adapting existing curricula to better fit tribal contexts.
Why does FDA include operations that may not be covered by FSMA today?
Because some tribal farms and businesses may choose to adopt FSMA-aligned practices for business reasons (buyer or marketplace requirements, growth planning, and other incentives), even if they do not currently meet regulatory thresholds for coverage.
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