Food and Drug Administration Grants

Food and Drug Administration

The primary purpose of this program is to develop and provide education and/or training, and outreach regarding FDA's Produce Safety Rule to produce farmers who are members of federally recognized Tribes. The program is expected to help Tribal farmers access appropriate technical assistance and may include Tribal farmers who are not currently required to comply with the rule but are interested in complying or see economic benefits in doing so. All activities should consider Tribal history, culture, and regional agricultural practices.

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

<p><span style="color: rgb(51, 51, 51);">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.</span></p>

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

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

<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

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

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

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

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

1. Assist FDA in meeting provisions of the FDA Food Safety Modernization Act;2. Support the efforts of Federal, State, and local government agencies to build an Integrated National Food Safety System;3. Establish systems for sharing, promotion, and collaboration of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to foster mutual reliance between Federal, State and local manufactured food regulatory programs and public health agencies;4. Assist FDA in the identification, development, delivery, promotion, and/or attendance of food safety and defense training programs to support conformance with regulatory program standards and provisions of FSMA;5. Support the advancement of the regulatory program standards and other initiatives that advance integration, including hosting in-person meetings.

Food and Drug Administration

FDA's CTP is seeking to develop a smoking machine adaptor for use with electronic nicotine delivery system (ENDS), cigars, and heated tobacco products that will require significant collaboration and research efforts with outside organizations. The selected organization(s) will develop a single universal adaptor, or standardized family of adaptors, for the attachment of ENDS, cigars, and heated tobacco products to existing smoking machines originally designed for use with cigarettes and make available to tobacco stakeholders, contract and government laboratories, and academic institutions.

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

In 2018, OPSA launched an effort to develop of a quantitative system-dynamic model of the opioid crisis to help FDA a) understanding the complexity of the interconnected mechanisms of the crisis, and b) assess potential impacts (intended and unintended) of possible policy actions to address the crisis. In Sept 2019, OPSA awarded a 1-year cooperative agreement (Harvard/Mass General; FDA's RFA-FD-19-026) to complete an initial version of the model ready for policy analysis, and in Aug 2020, OPSA awarded a 1-year cooperative agreement (Harvard/Mass General; FDA's RFA-FD-20-031) to account for societal outcomes beyond overdose as well as cost-effectiveness of potential policies. The current proposal will expand the FDA's model to more comprehensively incorporate fentanyl, stimulants and polysubstance use and their interactive effects on opioids use, misuse, addiction, use disorder treatment, and associated outcomes. The main focus of this project would be on modeling the growing number of opioid overdose deaths involving people who are primarily stimulant or polysubstance users, as an important emerging aspect of the opioids crisis. The research will also include quantification of the effects of harm reduction approaches (e.g., naloxone distribution to opioid users, increasing treatment availability for Opioid Use Disorder [OUD]) on overdoses involving fentanyl and other polysubstance use . Additionally the research will identify and incorporate aspects of mental health that are feasible for inclusion into the model.

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

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (known as the SUPPORT Act) was signed into law in October 2018. Section 3002 of the SUPPORT Act requires the Commissioner of Food and Drugs to develop evidence-based opioid analgesic prescribing guidelines for indication-specific treatment of acute pain where such guidelines do not exist. Consistent with the requirements of section 3002 of the SUPPORT Act, FDA launched an effort to develop a framework for evidence-based guidelines involving a contract with the National Academies of Science, Engineering, and Medicine (NASEM). In December 2019, NASEM provided a consensus report that identified the surgical procedures/medical conditions requiring research for the development of evidence-based guidelines to treat acute pain.FDA proposes to fund the development, dissemination, implementation, and evaluation of an evidence-based clinical practice guideline (CPG) for dental pain (surgical and non-surgical). The NASEM report identified dental surgeries (e.g., third molar extraction) and dental pain as priority areas for evidence-based guideline development because of the patient populations that are affected (e.g., adolescents and young adults), the high prevalence of the procedure, and the data that documents the efficacy of nonopioid pain management strategies for this procedure. Similarly, the most common diagnoses resulting in an opioid prescription in the emergency department were dental pain among adolescents and young adults. The NASEM report also recommends that organizations that develop evidence-based CPGs on opioid prescribing for acute pain establish a process for disseminating, implementing, and monitoring the uptake and impacts of the CPG on opioid prescribing practices.

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 agreements 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

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.

Food and Drug Administration

CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors.