Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed
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This Notice of Funding Opportunity from the Food and Drug Administration aims to advance a nationally Integrated Food Safety System by providing support for state manufactured food regulatory programs. The funding is structured across four primary tracks: the development and maintenance of Manufactured Food Regulatory Program Standards to ensure high-quality regulatory frameworks, the establishment of Food Protection Task Forces to integrate human and animal food protection systems, the creation of state-driven dietary supplement regulatory frameworks focusing on cGMP compliance, and the implementation of special projects to drive innovation within the food safety system. The program emphasizes the importance of mutual reliance, uniform performance measurement, and the reduction of foodborne illness hazards. By fostering collaboration between federal, state, local, tribal, and territorial agencies, as well as industry and academia, the initiative seeks to improve public health through enhanced surveillance, emergency response, and the sharing of project deliverables across programs.
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Full Description
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.
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