Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed

The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), is offering a cooperative agreement titled "Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives." This funding opportunity supports state-level animal food safety regulatory programs in achieving and maintaining full implementation of the Animal Food Regulatory Program Standards (AFRPS) within a five-year timeframe, while also promoting mutual reliance between state and federal regulatory systems. The opportunity is managed under the FDA's Human Food Program and Center for Veterinary Medicine. This grant offers two core tracks of funding: the AFRPS Development Phase for state programs new to AFRPS or with less than five years of prior participation, and the AFRPS Maintenance Phase for programs with at least five years of funding history under AFRPS. An optional Mutual Reliance track is available to Maintenance-level applicants who meet specific eligibility criteria, including a comprehensive inspection history under FDA contract. The program is intended to establish a nationally integrated food safety system by improving the capacity, consistency, and accountability of state animal food regulatory programs. In fiscal year 2025, the FDA anticipates making up to $10.6 million available across these tracks. The Development Track provides up to $300,000 per year for new participants. Maintenance Track funding is tiered into three levels ($150,000, $225,000, and $300,000 annually), determined by program size and workload metrics. The Mutual Reliance option provides additional support ranging from $50,000 to $300,000 based on the number of comprehensive inspections conducted. All programs are expected to implement strategic improvement plans, participate in regular FDA assessments, and align their regulatory systems with AFRPS elements and documentation requirements. Applications are due annually with cycles closing on July 25, 2025; March 1, 2026; and March 1, 2027. The earliest date applications can be submitted is June 25, 2025. All applicants must be U.S. state governments with an active FDA inspectional contract and a valid 20.88 agreement at the time of application. The program does not allow clinical trials and requires matching funds equal to or exceeding the previous year's food safety budget, adjusted for inflation. Application packages must be submitted through Grants.gov using the NIH ASSIST system or another approved method. Evaluation will focus on a combination of rationale, design, cooperation and integration with federal partners, and resource capacity, each weighted according to specific scoring criteria. Applications must include specific personnel assignments for each project track and clearly defined annual workplans. The FDA will play a substantial role post-award, including collaborative oversight, progress assessments, and technical assistance. For assistance, applicants are encouraged to contact Danielle Head (danielle.head@fda.hhs.gov) for financial or grants management questions, and Isaiah Isakson (isaiah.isakson@fda.hhs.gov, 406-465-9363) for scientific and research-related questions. Optional technical sessions will be held for each submission cycle, with the first session scheduled for July 1, 2025. The grant opportunity is forecasted to recur annually through at least 2027.

Attend optional Q&A sessions, use NIH ASSIST or S2S tools, contact FDA early for guidance