Food and Drug Administration Grants

Food and Drug Administration

The purpose of this NOFO is to collaboratively advance retail food initiatives to reduce foodborne illness. This funding opportunity aims to advance practices in retail food protection and identify opportunities for collaboration to reduce the occurrence of foodborne illness risk factors.This opportunity aims to assist retail food regulatory programs and industry in reducing foodborne illness by implementing effective intervention strategies designed to reduce the occurrence of foodborne illness risk factors; implementing and achieving full conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS); promoting use of risk-based inspection methods to effectively identify the occurrence of foodborne illness risk factors, conduct root cause analysis, assess gaps in industry active managerial control (AMC), and promote regulatory compliance; promoting adoption of the most recent version of the FDA Food Code; effectively responding to foodborne illness outbreaks; and responding to emerging food safety trends. The program is also intended to encourage the research, development, and implementation of industry food safety management systems and the prerequisite food safety culture necessary to achieve AMC of foodborne illness risk factors.

Food and Drug Administration

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.

Food and Drug Administration

<p>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).&nbsp;</p> <p><br></p> <p>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.</p> <p><br></p> <p>Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.</p> <p><br></p> <p>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.</p> <p><br></p> <p><span style="color: black;">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.</span></p>

Food and Drug Administration

<p>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:</p><p><br></p><p>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.</p><p><br></p><p>Develop and standardize processes, procedures, systems, and other methods to integrate federal and state animal food regulatory work resulting in mutual reliance.</p><p>Specific outcomes may include, but are not limited to:</p><p><br></p><p>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.</p><p><br></p><p>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.</p><p>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.</p>

Food and Drug Administration

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.

Food and Drug Administration

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.

Food and Drug Administration

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

Food and Drug Administration

NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens

Food and Drug Administration

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.

Food and Drug Administration

Laboratory Flexible Funding Model (LFFM)

Food and Drug Administration

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.

Food and Drug Administration

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Food and Drug Administration

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for inclusion as Animal and Veterinary Innovation Centers, which are intended to form long-term partnerships to address priority areas for FDA's Center for Veterinary Medicine (CVM). This includes CVM developing cooperative agreement(s) with academic research institutions (public and private) to: 1. Drive research that supports the development of interventions to prevent, control, or eliminate Highly Pathogenic Avian Influenza (HPAI) virus in animals, or interventions that reduce the circulation of the virus in the ecosystem. Work may also include other emerging zoonotic disease threats or One Health issues in future years. 2. Drive research that supports the development of intentional genomic alternations in animals and the advancement of regulatory science in this field, with a focus on intentional genomic alternations that support agricultural resilience, food security, animal health, or public health. 3. Drive research that supports the development of products for minor species, minor uses in major species (dogs, cats, horses, cattle, pigs, chickens, and turkeys) and other unmet veterinary medical needs in major species that create a significant animal or public health burden.

Food and Drug Administration

<p>The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for inclusion as Animal and Veterinary Innovation Centers, which are intended to form long-term partnerships to address priority areas for FDA's Center for Veterinary Medicine (CVM). This includes CVM developing cooperative agreement(s) with academic research institutions (public and private) to:&nbsp;</p> <p><br></p> <p>1. Drive research that supports the development of interventions to prevent, control, or eliminate Highly Pathogenic Avian Influenza (HPAI) virus in animals, or interventions that reduce the circulation of the virus in the ecosystem.&nbsp;Work may also include other emerging zoonotic disease threats or One Health issues in future years.&nbsp;</p> <p><br></p> <p>2. Drive research that supports the development of intentional genomic alternations in animals and the advancement of regulatory science in this field, with a focus on intentional genomic alternations that support agricultural resilience, food security, animal health, or public health.&nbsp;</p> <p><br></p> <p><span style="color: black;">3. Drive research that supports the development of products for minor species, minor uses in major species (dogs, cats, horses, cattle, pigs, chickens, and turkeys) and other unmet veterinary medical needs in major species that create a significant animal or public health burden.</span></p>

Food and Drug Administration

Animal and Veterinary Innovation Centers (U18)

Food and Drug Administration

The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Food and Drug Administration

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

Food and Drug Administration

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.

Food and Drug Administration

Vet-LIRN Capacity-Building Project and Equipment Grants (U18)

Food and Drug Administration

The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA), Office of Training, Education, and Development (OTED) is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.The goals of this Cooperative Agreement are to continue the development of the Integrated Food Safety System (IFSS) National Curriculum Standard (NCS) curriculum frameworks for regulatory stakeholders with the capacity to expand into other program areas as directed; further work on the development and validation of competency statements; and revise, develop and deliver courses to FDA stakeholders nationwide (other federal, state, local, tribal and territorial regulators). Under FSMA Section 209, FDA is directed to improve the training of state, local, territorial and tribal food safety officials and set standards and administer training and education programs to ensure a competent work force doing comparable work.

Food and Drug Administration

The intended outcome of this Funding Opportunity Announcement (FOA) is to advance efforts for a nationally integrated animal food safety system by assisting State animal food regulatory programs to achieve and maintain full implementation of the Animal Feed Regulatory Program Standards (AFRPS), and to provide optional funding for State animal food regulatory programs to perform regulatory work and promote compliance with the Preventive Controls for Animal Food (PCAF) regulation.

Food and Drug Administration

CBER, FDA seeks to support the development of innovative pathogen reduction technologies for whole blood and blood components to prevent transfusion-transmitted infectious diseases.

Food and Drug Administration

The intended outcome of this FOA is to collaboratively advance retail food initiatives to reduce foodborne illness. This cooperative agreement is intended to advance practices in retail food protection and identify opportunities for collaboration to reduce the occurrence of foodborne illness risk factors.

Food and Drug Administration

The Food and Drug Administration (FDA) Office of the Chief Scientist (OCS) and FDA Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) will annouce it's intent to accept and consider an application for the award of a grant to protect and promote the health of the American public by creating new, applied scientific knowledge, tools, standards and approaches to evaluate products more effectively, predictably and efficiently.