Federal Food and Nutrition Grants

Sodium-glucose co-transporter-2 inhibitors (SGLT2i) that were developed for the treatment of type 2 diabetes (T2D) have significant protective effects for cardiac and renal diseases for people with and without diabetes. However, SGLT2i are not currently approved for individuals with type 1 diabetes (T1D) and there is an increased risk of diabetic ketoacidosis (DKA) for this population. Despite this concern, these drugs are increasingly being prescribed off-label for people with T1D. Continuous ketone monitoring (CKM) is a rapidly evolving technology that could be utilized clinically to prevent DKA by an early warning of elevations in ketone levels.The purpose of this NOFO is to solicit applications for studies that will develop and test risk mitigation strategies that involve the clinical integration of CKM for the safe use of SGLT2i for people living with T1D so that they may benefit from the cardiac and renal protection and glucose-lowering effects of this drug class. The NOFO will support short-term, clinical trials to gain and disseminate knowledge on safety and glucose control with CKM and SGLT2i use.Possible topics include testing optimal insulin delivery in open and closed loop systems or multiple daily injections and developing clinical protocols to control or ameliorate elevated ketone levels in individuals with T1D who are receiving adjunct therapy with SGLT2i.

This funding opportunity supports researchers in planning high-risk, multi-center clinical studies focused on kidney, digestive, diabetes, and metabolic disorders, helping them develop essential protocols and administrative frameworks before conducting the actual trials.

This funding opportunity supports high-risk, multi-center observational studies aimed at advancing research on diabetes, digestive diseases, kidney disorders, and other related health conditions, encouraging diverse institutions to collaborate and innovate.

This funding opportunity supports high-risk, multi-center clinical trials aimed at addressing significant health issues related to diabetes, digestive diseases, and kidney disorders, encouraging diverse institutions to apply for impactful research that can transform clinical practices.

This funding opportunity supports early stage researchers in pursuing innovative and high-risk scientific projects that significantly diverge from their previous work, without the need for preliminary data.

This Notice of Funding Opportunity is issued to announce the availability of a Cooperative Agreement designed to assist the FDA in developing, implementing, and improving a nationally consistent system of support which facilitates the implementation of state and territorial produce safety regulatory programs that are modernized and aligned with the standards set forth in the FDAs Regulation: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (commonly referred to as the Produce Safety Rule).This goal shall be accomplished in partnership with the FDA by identifying, generating, sharing, and leveraging resources andinformation which aids in the development and implementation of national, state, and territorial produce safety regulatoryprograms that are nationally uniform and consistent with the Produce Safety Rule, and which improve their effectiveness andenhance their capabilities.

This grant provides funding for early stage investigators to pursue innovative and high-risk research projects involving human participants, without the need for preliminary data.

This funding opportunity supports U.S. educational institutions in developing programs that train a diverse workforce in research related to diabetes, digestive diseases, and kidney health, through skills courses and research experiences.

The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on potential risks from skin lightening products containing hydroquinone and/or mercury.Applicants will research and propose innovative and community-based strategies and activities that have the potential to strengthen the science base for education and public health awareness on the use of and potential risks from over-the-counter (OTC) skin lightening products.

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of 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 neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

This funding opportunity supports research that explores the effects of aging on individuals living with HIV, focusing on improving health outcomes and management strategies for this population.

This funding opportunity supports innovative research that investigates how aging affects individuals living with HIV, focusing on improving their health outcomes and addressing related challenges.

The purpose of this funding opportunity announcement (FOA) is to fund innovative research that will strengthen and advance minority health and health equity objectives.Areas of interest include:Proposals that focus on advancing equity in clinical trials by supporting efforts to advance diversity in clinical trials, equitable data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and equity of voices by increasing understanding of diverse patient perspectives, preferences, and unmet needs.

The FDA seeks an application to continue to maintain, manage existing consortia groups convened and established by the Critical Path Institute. This is a renewal of the cooperative agreement #5U18FD005320 as part of the Critical Path Initiative. This is in support of Critical Path Initiative introduced in Section 566 of the Federal Food, Drug, and Cosmetic Act. This includes developing innovative, collaborative projects in research, education, and outreach for fostering drug product innovation, enabling the acceleration of development, manufacturing, and translational therapeutics, enhancing safety, efficacy, quality, and performance. This funding opportunity will provide support, depending on availability of FDA funding.

This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA. Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.

The purpose of this FOA is to develop and maintain Rapid Response Teams (RRTs) to facilitate long-term improvements and innovation to the national integrated food safety system by unifying and coordinating federal/state/local human and animal food (HAF) emergency response efforts including:1) Strengthening the link among epidemiology, lab and environmental health/regulatory components;2) Improving States' regulatory and surveillance HAF protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development.

Addressing the Impact of Syndemics on the Health of People with HIV and Diseases and Conditions within the Missions of NIDDK and NHLBI (R01 Clinical Trial Optional)

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.

FDA announces the availability of fiscal year (FY) 2024 funds to support one or more projects to 1) collect antimicrobial use data from diverse animal sectors, including domestic livestock, poultry, companion animals (dogs, cats, and horses), and minor species (e.g., fish, sheep, goats, etc.) and 2) contribute to the development of data collection frameworks, including providing data and expertise as resources and a public-private partnership frameworks are established.This grant will support the continued advancement of FDA's initiatives to support antimicrobial stewardship in veterinary settings. It will also support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to improve understanding of antimicrobial use and foster antimicrobial stewardship in animal agriculture.

The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.