Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed

The intended outcome of this Notice of Funding Opportunity (NOFO) is to advance efforts for a nationally Integrated Food Safety System (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), Food Protection Task Force (FPTF) programs, Dietary Supplement (DS) programs, and special projects. For the purposes of this NOFO, the term state encompasses all eligible organizations as defined in Section 3.

MFRPS Development or Maintenance:

The purpose of this Notice of Funding Opportunity (NOFO) section is to advance efforts for a nationally Integrated Food Safety System (IFSS) by assisting state manufactured food regulatory programs to achieve and maintain conformance with the most current version of the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that state manufactured food regulatory programs implement a high-quality regulatory program through the development and maintenance of a regulatory framework that builds on and emphasizes mutual reliance with all programs. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help federal and state programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods.

Food Protection Task Force (FPTF):

The purpose of this funding option is to establish and/or support a Food Protection Task Force (FPTF) with diverse membership representative of stakeholders across the state that is responsible for promoting the integration of an efficient statewide human and animal food (HAF) protection system that addresses state and region-specific needs and that maximize the protection of the public health. These efforts include: establishing a food safety/protection network of subject matter experts, fostering educational opportunities, developing replicable resources and systematically fostering communication, education, outreach, cooperation and collaboration within the states among federal, state, local, tribal and territorial HAF protection, public health, agriculture, and regulatory agencies, industry, academia, and consumers to initiate and/or support HAF protection activities to improve public health.

A strong FPTF can also help improve human and animal food emergency surveillance, response, and post-response systems by focusing on preparedness, building strong communication channels, and establishing relationships with key players before food-related incidents occur.

Dietary Supplements:

The goal of this funding option is to facilitate the development of state driven dietary supplement regulatory framework and programs. The overall objective of this funding opportunity is to advance the adoption and implementation of the cGMPs for Dietary Supplements Rule codified at 21 CFR Part 111. Specifically, this track will provide funding support for dietary supplement training and program development activities.

Special Projects:

The purpose of this funding option is to develop and implement special projects that support innovation and integration in a IFSS using the MFRPS framework. This track will support other emerging food safety priorities that develop over the lifespan of the project. State programs will be expected to share project deliverables and resources developed with other programs.

Governments• U.S. Territory or PossessionThis opportunity is only available to the following State, Tribal or Territorial food safety programs:Manufactured food regulatory programs with current the FDA food safety inspection contracts (providing funding to state agency food protection regulatory programs), or those that meet the eligibility requirements and agree to enter into a food safety inspection contract with the FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement. Competition is limited to state, tribal and territorial manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in an IFSS.Applicants will be categorized under one of two funding tracks: MFRPS Development or MFRPS Maintenance (see eligibility criteria below). Within each funding track, an applicant may apply for additional funding options for which they meet the eligibility criteria (below).The applicant must hold a long-term food nonpublic information sharing agreement with the FDA pursuant to 20 CFR §20.88 (“20.88 agreement”) or agree to enter into a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025).Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction's needs both in terms of amounts of funding and number of project years.To ascertain an applicant's tier's funding level, please consult Section II. Award Information.Funding Track 1: MFRPS DevelopmentState programs are eligible for Funding Track 1 if they have received less than five (5) years funding under a past MFRPS cooperative agreement or have never received a MFRPS cooperative agreement.Applicants may request up to $300,000/year for this funding option.State programs will move to MFRPS Maintenance funding levels in the sixth year of funding under MFRPS cooperative agreements. Applicants with less than five (5) years funding under a past MFRPS cooperative agreement may elect to count years of MFRPS enrollment under the FDA Food Inspection Contract towards the five (5) years MFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (MFRPS Maintenance).2018-19 MFRPS Cooperative Agreement Recipients (RFA-FD-18-001): State programs who began receiving MFRPS cooperative agreement funding in 2018 and/or 2019 are not eligible for Funding Track 1 of this cooperative agreement. These state programs must request funding under Funding Track 2 (MFRPS Maintenance).2020 MFRPS Cooperative Agreement Recipients: State programs who began receiving MFRPS cooperative agreement funding in 2020 are only eligible to receive funding under Funding Track 1 (MFRPS Development) for year 1 of this two-year cooperative agreement.2021-22 MFRPS Cooperative Agreement Recipients: State programs who began receiving MFRPS cooperative agreement funding in 2021 and/or 2022 are eligible to receive funding under Funding Track 1 for years 1 and 2 of this cooperative agreement. See section titled, "MFRPS Funding Track 2" for variable funding levels and additional funding options.Programs who meet the eligibility requirements for Funding Track 1 (MFRPS Development):• Are also eligible to apply for a FPTF option.• Are not eligible to apply for Dietary Supplements or Special Projects funding options.Funding Track 2: MFRPS Maintenance State programs are eligible for Funding Track 2 if they have received five (5) years funding under a past MFRPS cooperative agreement. Applicants with less than five (5) years funding under a past MFRPS cooperative agreement may elect to count years of MFRPS enrollment under the FDA Food Inspection Contract towards the five (5) years MFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (MFRPS Maintenance).