Federal Food and Nutrition Grants

This funding opportunity supports researchers in developing innovative tools that can speed up drug development and improve regulatory processes, ultimately enhancing public health by facilitating faster access to effective treatments.

This Notice of Funding Opportunity (NOFO) requests applications to explore human pancreatic tissues and the immune compartment for the discovery of specific signaling or processing pathways that may contribute to the asymptomatic phase of T1D, the discovery of early biomarkers of T1D pathogenesis, the development of diagnostic tools for the detection and staging of early T1D in at-risk or recently-diagnosed individuals, and/or the identification and biological validation of therapeutic targets for the development of preventative or early treatment strategies. Successful applicants will join the Consortium on Beta Cell Death and Survival (CBDS), whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and of preventing the progression to autoimmunity. The CBDS is part of a collaborative research framework, the Human Islet Research Network (HIRN, https://hirnetwork.org/), whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This NOFO will only support studies with a primary focus on increasing our understanding of human disease biology (as opposed to rodent or other animal models). This NOFO will not accept applications proposing a clinical trial.

Notice of Funding Opportunity Description Background The Food and Drug Administration (FDA) protects the public health by ensuring that medical products intended to be marketed in the United States are safe and effective for their intended use. FDA stakeholders are exploring innovative ways to produce scientific evidence in support of regulatory submissions, including the development of new data sources, study designs, methodologies, and technologies. FDA encourages and facilitates the use of such innovative approaches while ensuring that the scientific evidence supporting marketing approvals meet our high evidentiary standards. The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the FDA, regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. DHTs may rely on or work with other technologies that support their operation, such as general-purpose computing platforms (e.g., smartphones) and communication networks. Among other activities relating to the use of DHTs, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter Framework ). The Framework highlights FDA’s DHT efforts including workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. In addition, FDA’s webpage DHTs for Drug Development (available at: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development) provides an overview of the ongoing DHT efforts, including demonstration projects. A variety of project types are welcomed under this NOFO, applicable to drugs and biologics (not devices). FDA is particularly interested in projects that evaluate the use of DHTs in drug development. Project Objectives The overarching goal of this notice of funding opportunity (NOFO) is to explore the role of DHTs (e.g., actigraphy, photography, environmental sensors) in the evaluation of new drugs. These projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations. The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of environmental sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., dementia) through the use of DHTs

This program provides funding to empower local organizations and communities in specific countries to lead their own development initiatives, focusing on inclusivity and sustainability.

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.

This funding opportunity provides financial support to U.S.-based organizations currently involved in enhancing food safety systems, focusing on collaboration and data sharing among federal, state, and local agencies.

This funding opportunity supports innovative, interdisciplinary research projects that aim to fill critical knowledge gaps and advance scientific understanding in areas related to kidney, diabetes, and digestive diseases.

The purpose of the SNAP Fraud Framework Implementation Grant Program is to support State agency efforts to improve and expand recipient fraud prevention, detection, and investigation efforts using the procedures, ideas and practices outlined in the SNAP Fraud Framework.Organizational Management: This objective aims to help States establish and communicate priorities, organize employees, and manage both large-scale and day-to-day processes. Many of the concepts described in this component are the foundation for successful program integrity initiatives.Performance Measurement: This objective offers recommendations encouraging States to consistently capture and analyze their own performance.Recipient Integrity Education: This objective provides targeted integrity education initiatives to help ensure recipients have the necessary information and tools to use SNAP benefits as intendedpreventing fraud before it occurs. When producing recipient integrity education materials, States are encouraged to educate the public and applicants about SNAP fraud, rather than emphasize the consequences as a deterrent to applying.Fraud Detection: Here, the SNAP Fraud Framework stresses the importance of proactively detecting fraud from the application process and continuing throughout the recipients time in the Program.Investigations and Dispositions: This objective aims to provide states with tools and suggestions to improve fraud case management from initial fraud referral through disposition.Analytics and Data Management: This objective details the necessary people, processes, and technology to launch and maintain an analytics capability. Data analytics can play a valuable role in preventing, detecting, and investigating SNAP fraud.Learning and Development: The final objective contains recommendations for States to invest in training and professional development opportunities to promote employee engagement and to ensure employees are aware of new and emerging trends in fraud.Please read the entire request for applications (RFA) for additional information.

This funding opportunity supports students enrolled in dual-degree medical and research training programs, helping them develop into independent physician-scientists through mentored research and clinical training.

This funding opportunity supports clinical trials aimed at developing new therapies for rare neurodegenerative diseases, such as ALS, and is open to a wide range of eligible organizations, including universities and nonprofits.

This funding opportunity supports research initiatives focused on non-communicable diseases related to HIV at institutions in low- and middle-income countries, encouraging innovative projects and collaborations to improve health outcomes for people living with HIV.

This Notice of Funding Opportunity (NOFO) seeks to foster new multi-disciplinary teams to address how HIV Comorbidities and co-infections within the missions of NIDDK and NIAID interact with viral reservoirs, potentially confounding cure strategies aimed at either sustained viral suppression or elimination from the body. These teams will mechanistically interrogate the impact of inflammation, metabolic perturbations, or other pathophysiological processes associated with these comorbidities or co-infections on reservoir dynamics, and/or the interplay of these conditions and co-infections on HIV reservoir biology in ways that are likely to interact with potential cure strategies.

This funding opportunity provides financial support to U.S.-based small businesses that have previously received NIH Phase II or Phase IIB awards, helping them advance their research projects toward commercialization through technical assistance and late-stage development activities.

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 provides financial support to U.S.-based organizations, including universities, nonprofits, and businesses, to help outsourcing facilities produce critical medications that are in short supply and vulnerable to fraud.

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 funding opportunity provides financial support to nonprofit organizations and government agencies to create projects that incentivize SNAP households to purchase and consume healthy fluid milk.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Duke Universitys Duke Clinical Research Institute (DCRI) to support the Clinical Trials Transformation Initiative (CTTI).

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 purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.