Food and Drug Administration grants

The goal of this NOFO is to fund veterinary diagnostic laboratories in the Vet-LIRN network for grants associated with projects and equipment. Specific objectives include: 1. Supporting the development, adaptation, or verification/validation of new methods associated with animal food issues or antimicrobial resistance. 2. Short-term surveillance or monitoring efforts aligned with the CVM mission. 3. Supporting equipment for testing or developing tests associated with animal food-related issues or antimicrobial resistance, including those for emerging technologies. 4. Developing projects related to antimicrobial stewardship, in alignment with CVM's key initiatives in this area. 5. Contributing as part of Vet-LIRN's AMR monitoring program, including sequencing isolates. 6. Supporting work associated with One Health, including emerging diseases such as COVID-19, when funding is available.

This cooperative agreement is intended to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS).  The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.

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.