Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed) | PAR 20 091

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.

• 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).

Apply for PAR 20 091

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: