RFA-FD-25-020 Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

The purpose of this Notice of Funding Opportunity (NOFO) is to advance efforts for a nationally integrated animal food safety system providing state animal food regulatory programs the ability to achieve full implementation of the Animal Food Regulatory Program Standards (AFRPS) within 5 years and to maintain full implementation. This NOFO will also fund optional projects for state animal food regulatory programs to: Advance food safety and protect public health by strengthening partnerships with the FDA and other state animal food regulatory partners through sharing, collaboration, coordination, and leveraging each other’s expertise, work, data, and enforcement actions. Develop and standardize processes, procedures, systems, and other methods to integrate federal and state animal food regulatory work resulting in mutual reliance. Specific outcomes may include, but are not limited to: State animal food regulatory programs will achieve and maintain implementation of the AFRPS, which is recognized as a critical element to creating a national, fully integrated food safety system. Operational use of standardized animal food regulatory systems developed by state programs to compel federal reliance on state regulatory work and resources and reciprocal state reliance on federal work and resources, resulting in mutual reliance. This project will strengthen and improve FDA efforts to build an integrated food safety system by building high quality state animal food regulatory programs that can promote regulatory compliance and prevent foodborne illnesses.

This Funding Opportunity Announcement (FOA) issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), builds upon the National Antimicrobial Resistance Monitoring System (NARMS) which was initiated in 1996 as one of the key activities in a national action plan to combat antibiotic resistance threats. The purpose of this FOA is to protect and promote public health by enhancing, strengthening, and sustaining antibiotic resistance surveillance in retail food specimens within the NARMS program. The NARMS cooperative agreement is intended to improve the detection of antibiotic resistance among bacteria in food commodities, as well as expand to new sites to expand the scope of sampling. Measurable outcomes of the program will be in alignment with the NARMS Objectives.

The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.