Opportunity Information: Apply for PAR 20 091
This grant opportunity, titled "Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)" (Funding Opportunity Number PAR 20-091), is a discretionary cooperative agreement offered by the U.S. Food and Drug Administration (FDA) under the Department of Health and Human Services. It sits in the consumer protection and food safety space (CFDA 93.367) and is designed as an expansion supplement to an existing FDA funding model originally launched under RFA-FD-18-001, which focused on building and maintaining infrastructure for state manufactured food regulatory programs. In practical terms, this is not a brand-new standalone program; it is intended to extend and deepen work already underway by current grantees or eligible state-type partners by adding a focused set of activities related to the Food Safety Modernization Act (FSMA) preventive controls requirements for human food.
The central purpose of the expansion is to strengthen a nationally Integrated Food Safety System (IFSS) by helping state manufactured food regulatory programs more fully adopt and implement the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, commonly referred to as the Preventive Controls for Human Food (PCHF) Rule. The PCHF Rule is meant to reduce food safety risks by ensuring that human food facilities use modern preventive approaches: maintaining baseline sanitation and manufacturing controls (cGMPs), identifying potential hazards through hazard analysis, and putting risk-based preventive controls in place to prevent or significantly minimize those hazards. This funding is therefore aimed at improving how state programs regulate and oversee manufactured food facilities so that inspections, compliance actions, and overall program operations align with the federal preventive controls framework under 21 CFR Part 117.
The opportunity emphasizes capacity building rather than one-off projects. Grantees are expected to develop the infrastructure, program components, and trained workforce needed for full implementation of the PCHF Rule within their existing human food safety systems. Examples of supported activities include establishing a PCHF training coordination and monitoring program for state regulators so inspectors and compliance staff are consistently trained and tracked; creating or expanding an inspection and compliance program capable of conducting full-scope preventive controls inspections under 21 CFR Part 117 (not limited to basic sanitation or traditional GMP checks); and improving data and information-sharing capabilities with FDA to support joint planning, transparency, and coordination that are key features of an integrated national system. The program also supports strengthening the underlying legal and regulatory foundation at the state level, such as regulatory drafting, legislative research, and other work that helps modernize statutes or rules so state authorities can effectively implement and enforce preventive controls expectations. Overall, the theme is building durable state program capability to run a preventive controls program that can operate at scale and in alignment with FDA.
Administratively, the award instrument is a cooperative agreement, which typically means there is substantial federal involvement compared with a standard grant, often including collaboration, coordination, and shared planning with the FDA during the period of performance. The anticipated award ceiling is $300,000 per award, with an expected total of 35 awards. The original posting date was January 21, 2020, and the opportunity used multiple annual deadlines: March 25, 2020; March 25, 2021; and March 25, 2022 (all by 11:59 PM Eastern Time). Eligibility is listed broadly as "Others (see text field entitled Additional Information on Eligibility for clarification)," and the notice explains that for the purposes of this funding announcement the term "State" is used broadly to encompass all eligible organizations described in the eligibility section, not solely traditional state agencies in the narrow sense.
In short, this FDA supplement is meant to help state-level manufactured food regulatory programs move from general food safety infrastructure building into more complete, consistent, and sustainable implementation of FSMA preventive controls for human food. The expected result is a stronger, better trained, better connected regulatory workforce and program structure that can perform full preventive controls inspections, share data effectively with FDA, support modernized legal authorities, and contribute to an integrated national food safety system focused on prevention rather than reaction.Apply for PAR 20 091
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (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): 93.367.
- This funding opportunity was created on Jan 21, 2020.
- Applicants must submit their applications by Mar 25, 2022 Multiple Deadlines March 25, 2020, by 1159 PM Eastern Time. March 25, 2021, by 1159 PM Eastern Time. March 25, 2022, by 1159 PM Eastern Time.. (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 $300,000.00 in funding.
- The number of recipients for this funding is limited to 35 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement (PAR 20-091)
What is the official title of this grant opportunity?
The opportunity is titled "Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR 20-091.
Which federal agency is offering this opportunity?
This is offered by the U.S. Food and Drug Administration (FDA), under the U.S. Department of Health and Human Services (HHS).
What type of funding mechanism is this?
The award instrument is a discretionary cooperative agreement.
What does it mean that this is a cooperative agreement?
A cooperative agreement typically indicates substantial federal involvement during the project period, meaning FDA is expected to collaborate with awardees through coordination and shared planning rather than simply issuing funds with minimal involvement.
Is this a brand-new standalone grant program?
No. This is described as an expansion supplement to an existing FDA funding model originally launched under RFA-FD-18-001. It is intended to extend and deepen work already underway.
What is the connection to RFA-FD-18-001?
RFA-FD-18-001 focused on building and maintaining infrastructure for state manufactured food regulatory programs. This supplement expands that work by adding a focused set of activities tied to FSMA preventive controls for human food.
What is the main purpose of this supplement?
The central purpose is to strengthen a nationally Integrated Food Safety System (IFSS) by helping state manufactured food regulatory programs more fully adopt and implement FSMA preventive controls requirements for human food.
Which FSMA regulation is the focus of this funding?
The focus is the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, commonly referred to as the Preventive Controls for Human Food (PCHF) Rule.
What is the PCHF Rule intended to do?
The PCHF Rule is meant to reduce food safety risks by ensuring human food facilities use preventive approaches, including baseline sanitation and manufacturing controls (cGMPs), hazard analysis, and risk-based preventive controls to prevent or significantly minimize hazards.
What federal regulation is referenced for alignment?
The opportunity emphasizes aligning state program oversight and operations with the federal preventive controls framework under 21 CFR Part 117.
What kinds of outcomes is the FDA trying to achieve through this funding?
The expected result is stronger state regulatory programs with a better trained workforce, fuller capability to conduct preventive controls inspections, improved data and information sharing with FDA, stronger legal and regulatory foundations, and overall progress toward an integrated national food safety system focused on prevention.
Is the focus on one-time projects or long-term capability?
The opportunity emphasizes capacity building rather than one-off projects. The intent is to develop durable infrastructure, program components, and workforce capability for full PCHF implementation.
What are examples of activities this supplement can support?
Examples mentioned include: establishing a PCHF training coordination and monitoring program for state regulators; creating or expanding an inspection and compliance program capable of full-scope preventive controls inspections under 21 CFR Part 117; improving data and information-sharing capabilities with FDA; and strengthening state legal and regulatory foundations through activities such as regulatory drafting and legislative research.
What does "full-scope preventive controls inspections" imply in this context?
It means inspections and compliance activities that cover preventive controls requirements under 21 CFR Part 117, not just basic sanitation or traditional GMP-only checks.
How does training fit into the program?
Training is a highlighted component, including coordination and monitoring to ensure inspectors and compliance staff are consistently trained and that training status can be tracked.
Why does the opportunity emphasize data and information sharing with FDA?
Improved data and information sharing is framed as essential for joint planning, transparency, and coordination, which are core features of a nationally integrated food safety system.
Does the opportunity address state laws and regulations?
Yes. It supports strengthening the legal and regulatory foundation at the state level, including work like regulatory drafting and legislative research to modernize statutes or rules so state authorities can implement and enforce preventive controls expectations.
What program area does this opportunity fall under?
It sits in the consumer protection and food safety space and is associated with CFDA 93.367.
What is the maximum award amount?
The anticipated award ceiling is $300,000 per award.
How many awards were expected?
The opportunity indicated an expected total of 35 awards.
When was the opportunity originally posted?
The original posting date was January 21, 2020.
What were the application deadlines?
The opportunity used multiple annual deadlines: March 25, 2020; March 25, 2021; and March 25, 2022. Each deadline was listed as 11:59 PM Eastern Time.
Who is eligible to apply?
Eligibility is listed as "Others (see text field entitled Additional Information on Eligibility for clarification)." The notice also explains that the term "State" is used broadly to encompass all eligible organizations described in the eligibility section, not only traditional state agencies in the narrow sense.
Does the opportunity limit clinical trials?
Yes. The title specifies "U18 Clinical Trials Not Allowed."
What kinds of programs are the primary target for this funding?
The funding is aimed at state-level manufactured food regulatory programs and eligible state-type partners working to implement and operate FSMA preventive controls oversight for human food facilities.
What is the overall theme of the work supported by this supplement?
The theme is building durable, scalable state program capability that aligns with FDA preventive controls expectations, including workforce development, inspection and compliance modernization, information sharing, and strengthening legal authorities.
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