Opportunity Information: Apply for RFA FD 22 019
This opportunity is a Food and Drug Administration (FDA) cooperative agreement supplement focused on strengthening how state and federally recognized tribal partners respond when manufactured food samples raise compliance concerns. It is framed as a "revision application," meaning it is intended as an expansion or supplement tied to existing work under the Laboratory Flexible Funding Model (LFFM). The central public health aim is to help grantees build the practical capacity and capability to take appropriate follow-up actions after laboratory testing identifies samples that are confirmed violative or potentially violative. In plain terms, the program is meant to close the gap between finding a problem in the lab and taking effective regulatory or enforcement steps to protect consumers.
A core theme of the award is integration. The FDA is looking for tighter coordination between laboratory functions (sampling, testing, confirmation, data reporting) and regulatory functions (compliance decisions, enforcement actions, communications, and product control measures). By expanding into compliance and enforcement, the program supports a more complete system that can prevent problems before they spread, identify hazards faster, contain issues once they are detected, and remove adulterated, contaminated, or mislabeled manufactured food products from the marketplace when needed. The emphasis is not just on generating test results, but on ensuring those results lead to timely, appropriate action that reduces risk to the public.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U18). A cooperative agreement typically implies substantial involvement from the FDA compared with a standard grant, such as ongoing collaboration, technical input, and alignment with federal priorities and program expectations. Clinical trials are explicitly not allowed, so funded activities should be operational, programmatic, and regulatory in nature rather than clinical research.
Eligible applicants are limited to state governments and federally recognized Native American tribal governments. The funding opportunity is issued by the Department of Health and Human Services (HHS), specifically the FDA, and it sits within the broad activity area of agriculture, consumer protection, and food and nutrition. The opportunity is identified by Funding Opportunity Number RFA-FD-22-019 and is associated with CFDA number 93.103.
In terms of scale and competition, the program anticipated up to 15 awards, with an award ceiling of $100,000 per award. The posting indicates a creation date of January 26, 2022, and an original closing date of April 4, 2022. Overall, the supplement is designed to help participating jurisdictions build a more end-to-end manufactured food protection system where lab findings reliably trigger well-coordinated compliance and enforcement responses, ultimately improving the prevention and control of unsafe or inaccurately labeled food products in commerce.Apply for RFA FD 22 019
- 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 "Revision Applications - Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (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 Jan 26, 2022.
- Applicants must submit their applications by Apr 04, 2022. (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 $100,000.00 in funding.
- The number of recipients for this funding is limited to 15 candidate(s).
- Eligible applicants include: State governments, Native American tribal governments (Federally recognized).
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is a Food and Drug Administration (FDA) cooperative agreement supplement focused on strengthening how state and federally recognized tribal partners respond when manufactured food samples raise compliance concerns. It is intended to improve the follow-through after laboratory testing identifies samples that are confirmed violative or potentially violative.
What is the main public health purpose of the supplement?
The central aim is to close the gap between finding a problem in the lab and taking effective regulatory or enforcement steps that protect consumers. The supplement supports building the practical capacity and capability to take appropriate follow-up actions when lab results indicate a compliance issue.
What does "manufactured food samples raise compliance concerns" mean in this context?
It refers to situations where sampling and testing of manufactured food products results in findings that suggest the product may be adulterated, contaminated, or mislabeled, creating a need for compliance decisions and potential enforcement or control measures.
What does it mean that this is a "revision application"?
The opportunity is framed as a revision application, meaning it is an expansion or supplement tied to existing work under the Laboratory Flexible Funding Model (LFFM), rather than a standalone, unrelated award.
How is this supplement connected to the Laboratory Flexible Funding Model (LFFM)?
The supplement is intended to build on existing LFFM work by extending the focus beyond laboratory testing and into the compliance and enforcement activities that should follow when laboratory results indicate problems.
What types of improvements is the FDA trying to support with this supplement?
The FDA is emphasizing end-to-end improvements, including preventing problems before they spread, identifying hazards faster, containing issues once detected, and removing adulterated, contaminated, or mislabeled manufactured food products from the marketplace when needed.
Why is "integration" a core theme of the award?
The program is designed to strengthen coordination between laboratory functions (such as sampling, testing, confirmation, and data reporting) and regulatory functions (such as compliance decisions, enforcement actions, communications, and product control measures). The goal is to ensure lab results lead to timely, appropriate action that reduces public health risk.
What laboratory functions are specifically mentioned as part of the integrated approach?
The opportunity highlights sampling, testing, confirmation, and data reporting as laboratory functions that should connect more directly with compliance and enforcement activities.
What regulatory functions are specifically mentioned as part of the integrated approach?
The opportunity highlights compliance decisions, enforcement actions, communications, and product control measures as regulatory functions that should be tightly coordinated with laboratory activities.
What is the funding mechanism for this opportunity?
This is a discretionary funding opportunity using a cooperative agreement mechanism (U18).
What does a cooperative agreement (U18) imply for how the project will be carried out?
A cooperative agreement typically implies substantial involvement from the FDA compared with a standard grant. In practice, this can include ongoing collaboration, technical input, and alignment with federal priorities and program expectations.
Are clinical trials allowed under this opportunity?
No. Clinical trials are explicitly not allowed. Funded activities should be operational, programmatic, and regulatory in nature rather than clinical research.
Who is eligible to apply?
Eligible applicants are limited to state governments and federally recognized Native American tribal governments.
Can entities other than state governments and federally recognized tribal governments apply?
Based on the information provided, eligibility is limited to state governments and federally recognized Native American tribal governments.
Which federal agency is offering this opportunity?
The opportunity is issued by the Department of Health and Human Services (HHS), specifically the Food and Drug Administration (FDA).
What is the activity area for this funding opportunity?
The opportunity sits within the broad activity area of agriculture, consumer protection, and food and nutrition.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-22-019.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
How many awards were anticipated?
The program anticipated up to 15 awards.
What is the maximum award amount?
The award ceiling is $100,000 per award.
When was this opportunity created and when did it close?
The posting indicates a creation date of January 26, 2022, and an original closing date of April 4, 2022.
What kinds of outcomes is the FDA trying to achieve through this supplement?
The intended outcome is a more complete manufactured food protection system where laboratory findings reliably trigger well-coordinated compliance and enforcement responses, improving prevention and control of unsafe or inaccurately labeled food products in commerce.
What does "confirmed violative" versus "potentially violative" mean in the context of this opportunity?
Both terms refer to laboratory testing outcomes that raise compliance concerns. "Confirmed violative" indicates that testing has confirmed a violation, while "potentially violative" indicates results that suggest a possible violation and may require follow-up actions.
What is the practical problem this supplement is trying to solve?
It is designed to address the operational gap between generating laboratory results and ensuring those results lead to timely compliance decisions and enforcement or control actions that protect public health.
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