FDA - Food and Drug Administration Grants

FDA - Food and Drug Administration

In 2023, the United States imported $732 million in food and agricultural products from Africa, a notable increase from $627 million in 2020 and $599 million in 2018. (Source: Congressional Research Service, African Growth and Opportunity Act (AGOA), July 18, 2019; January 6, 2022; and July 17, 2024.) However, this growth in food imports has been accompanied by a troubling rise in FDA entry refusals. Between 2014 and 2024, across 27 African countries (including Benin, Burkina Faso, Botswana, Congo, Central African Republic, Côte d’Ivoire, Cameroon, Ethiopia, Ghana, Gambia, Guinea, Kenya, Morocco, Madagascar, Mali, Malawi, Niger, Nigeria, Rwanda, Sudan, Senegal, Togo, Uganda, Yemen, South Africa, Zambia, and Zimbabwe), FDA refusals for imported food products surged from 337 in 2014 to 515 in 2023. Alarmingly, in just the first 11 months of 2024, refusals more than doubled to 1,008. (Source: FDA Refusal Reports, FDA Import Refusals.) These figures highlight the increasing demand for food imports from emerging markets like Africa and the growing risks of unsafe products entering U.S. borders. For many overseas food and agricultural businesses, the United States represents a coveted market. However, the rise in exports also underscores the critical need to ensure these products meet stringent safety and quality standards. Establishing robust food safety systems early in the production and distribution process is essential to mitigate risks, protect public health, and facilitate access to the U.S. market. This proactive approach also generates significant cost savings and economic benefits for U.S. global trade partners, while fostering safer and more sustainable trade practices. To address these challenges, FES will develop a digital platform to deliver virtual training, disseminate critical information, and validate food safety practices. This system will equip food producers in emerging markets with the tools to implement global standards and successfully pass a full HACCP audit. By partnering with local in- country organizations, FES will provide these services at an affordable cost. Businesses will pay for the service, with FES collecting a small margin to maintain and update training materials and standards. Food producers that meet required adoption levels will be referred to global certification bodies, such as LRQA and EAGLE, which have expressed interest in collaborating with FES on this initiative. This innovative program will not only enhance the safety and quality of imported foods but also support the economic development of emerging markets by enabling food businesses to access lucrative export opportunities in the United States. Following Phase 1, the program will be expanded to other countries and scaled to serve more food companies seeking to export to the U.S. and other global markets.

FDA - Food and Drug Administration

Phase I Proposal: “GAS SENSORS FOR FOOD SAFETY AND ECONOMY IN THE FOOD SUPPLY CHAIN” Summary/Abstract The proposed work will provide advanced processing and material measurements [low-cost sensor nodes] that will have enormous impacts by improving the food safety for widespread societal benefit. Additionally, the economic benefit will be large - A reduction of the 15% estimated waste4.b by even 10% is this large volume industry will have a potential $15B impact! An opportunity exists to develop sensor nodes that monitor quality and safety of crops and produce, as well as reducing waste in several sectors of the food industry. Our work will start with gas sensors for ethylene, ozone and food odor gases. The most frequently used sensors in produce storage and transport processes include those for O2, CO2, and T, P, RH as well as the ripening phytohormone, ethylene. Ozone is used for ripening control as well as sterilization. In Phase II we will expand to additional safety and QA parameters that include odor indicators of spoilage [e.g., H2S, ammonia, and amines]. Currently, analysis of food related gasses, e.g. those for controlled atmosphere [CA] storage and shipping, is almost invariably performed with large instrumentation and/or cumbersome laboratory protocols. The opportunity exists to revolutionize how the food industry addresses yield, loss and safety in this industry. To illustrate our innovative approach to addressing this need, IE Sensors proposes development of an accurate and sensitive (<10 ppb DL), extremely low-power, real-time sensor to monitor ethylene in plant and produce processing, storage and transportation facilities. We will integrate the ethylene sensor with an ozone sensor of similar design to monitor atmosphere conditions (T,P,RH, O3, ethylene). In Phase II, we will add odor gasses as well as smart algorithms to evaluate freshness and quality of the food product. Our patented manufacturing technology at IE sensors allows for the creation of a complete line of low power EC sensors for the target gasses herein. The printed circuitry uses ASIC components that will be sourced in the USA and enable a SIP [system in package] approach that contains all three critical elements in one package: 1] sensing, 2] computation with AI/ML for accurate measurements and auto-calibration, and 3] telemetry for effective feedback of actionable information. The proposed work leverages recent gas sensor work and AI sensor systems developments and provides an opportunity to achieve the selective detection of critical gases like ethylene as well as design an innovative prototype sensor systems that will target the trillion dollar food industry. This SBIR research is both inventive [will result in patents for new sensor materials and designs] and innovative [providing integrated IoT enabled sensor modules with performance and cost advantages for customers in CA-storage and shipping, and eventually within the food supply chain]. 1

FDA - Food and Drug Administration

PROJECT SUMMARY The Society for Research on Nicotine and Tobacco (SRNT) is the only international scientific society dedicated exclusively to the field of nicotine and tobacco research. In fiscal 2025 SRNT has nearly 1,200 members from more than 40 countries, with approximately 85 percent of those members being affiliated with U.S. academic, research, government, advocacy, and related organizations. The overall objective of the SRNT Annual Meeting is to stimulate advancement in the field of nicotine and tobacco research through the presentation of timely and cutting-edge research, discussion, and networking. It is the hallmark conference in the field where investigators, advocates, and policymakers can learn about the latest scientific findings, including novel products in the marketplace and effective interventions and policies to reduce tobacco use in the U.S. and in other countries. The SRNT Annual Meeting provides a crucial venue for the presentation of the rapidly evolving tobacco regulatory science research findings to the major keyholders in research and policy. The aims of this conference grant are to: 1) ensure that tobacco regulatory science content is presented in ways that are maximally informative to FDA and to researchers in the field; and 2) to support the career of trainees and early career investigators in tobacco regulatory science via opportunities for special oral sessions, professional development forums, travel awards, and other recognition. To meet both aims, SRNT’s Program Committee meets regularly throughout the year to plan the content and format of the SRNT 2026 Annual Meeting, aligning the presentation of scientific content with research priorities in the Tobacco Regulatory Science Program (TRSP). The Committee will curate paper sessions on specific topics that highlight advances in the area, foster scientific discussion and debate, and stimulate collaboration across researchers. The conference grant will also support at least 20 travel awards for trainees and early career investigators presenting on content related to the CTP and NIH TRSP research priorities. These interactions will facilitate the development of novel questions and approaches to tobacco regulatory science research while supporting the careers of future researchers in this important research discipline.

FDA - Food and Drug Administration

Abstract Acquired aplastic anemia (AA) is a life-threatening disorder caused by an autoreactive T-cell mediated destruction of hematopoietic stem cells resulting in the inability to produce adequate red blood cells, white blood cells and platelets. Acquired AA is extremely rare, occurring in 2-6 patients per million. There are between 600- 900 new cases each year in the United States. While AA can occur at any age there is a bi-modal distribution with peaks in late childhood/early adolescence and in older adults. Patients with AA are susceptible to potentially fatal opportunistic infections, clonal hematopoiesis/leukemogenesis, and chronic transfusion burden. The workup of a patient with suspected AA takes several weeks during which time the patient receives only supportive care. Immune suppression therapy (IST) and bone marrow transplant (BMT) are the two therapies available for patients once a diagnosis is definitive. For patients with an available matched related donor (MRD), BMT is the standard of care (SOC). Patients lacking a MRD traditionally received IST although many institutions are now prioritizing alternative donor transplant. IST has a 50% response rate over time with the other half of patients requiring additional therapy. BMT has a higher disease-free survival rate but increased potential toxicities including graft versus host disease, infertility and graft rejection. The decision of which therapy to pursue is often the most anxiety-provoking time for families with children that have newly diagnosed AA. This Phase 2a/2b Trial Emapalumab: A Window of Opportunity in Pediatric Aplastic Anemia leverages data showing that the Interferon-gamma (IFNγ) pathway is associated with the pathogenesis of AA. Pediatric patients with newly diagnosed AA will receive a prophase of an IFNγ neutralizing monoclonal antibody called emapalumab. This prophase will not add time to curative therapy and will occur during the workup period between presentation and start of definitive therapy. At the conclusion of the prophase, patients that have a hematologic response will be consolidated with IST while those that do not will receive institutional SOC. In this way we create an algorithm to try and identify patients that are most likely to have a favorable response to IST. This data-driven identification of which patient should receive IST will help alleviate parental anxiety in making these decisions without sufficient information. Aim 2 of this project seeks to extend our previous findings that distinct patterns of pediatric clonal hematopoiesis are associated with poor outcomes after IST. Conversely, lack of these markers aligned with favorable IST responses. We will prospectively validate these findings and assess if these specific clonal changes can be used as predictive biomarkers for response to IST. We will also examine if an early upfront prophase with emapalumab can prevent and/or minimize emergence of clonal hematopoiesis by preserving larger reservoirs of hematopoietic stem cells. By combining the data from these two aims, we hope to provide an algorithm to identify pediatric patients with aplastic anemia that are most likely to be cured by IST.

FDA - Food and Drug Administration

Effective engagement with the public is essential to expand the impact of the U.S. Food and Drug Administration, and for the efficient transfer of information and insights among the Agency, patients, academia, consumers, healthcare, and regulated industry. Through PRISM: Pathways for Regulatory Innovation and Strategic Modernization, the Reagan-Udall Foundation for the FDA proposes a multi-year effort to support the FDA's mission to protect and promote the public's health. As a Congressionally chartered, independent nonprofit, the Foundation serves as a neutral bridge between FDA and diverse stakeholders, delivering applied regulatory science, real-world insights, and transparent engagement. The Foundation does not participate in regulatory decision-making. Building on more than 70 collaborative projects completed between 2020 and 2025, the PRISM project portfolio advances FDA priorities through three Specific Aims: 1) Support the Development and Use of Regulatory Science Tools, 2) Support Programs and Research to Enhance Development of and Access to FDA-Regulated Products, and 3) Engagements, Convenings, and Operational Evaluations to Support the Work of FDA. Aim 1 strengthens regulatory science tools, with emphasis on modern use of real-world data and artificial intelligence, evaluation of data transparency, trust, and governance, and assessment of the predictive utility of animal studies to support efforts to reduce animal testing. Aim 2 focuses on improving development of and access to FDA-regulated products by expanding patient- and consumer-centered initiatives, enabling access to investigational new drugs, studying appropriate use of controlled substances, supporting gold-standard food and nutrition research, incentivizing drug development for animals, and assisting rapid response collaboration during cross-sectoral outbreaks. Aim 3 leverages the Foundation's expertise in convenings—roundtables, expert panels, and public meetings—to support FDA implementation across complex policy areas, including drug development, cosmetics oversight, rare diseases, food safety, mental health, and counterfeit products. Projects are jointly designed with FDA staff, delivered on defined timelines and budgets, and culminate in public outputs to promote learning, transparency, trust, and impact. Collectively, through PRISM, the Foundation provides FDA with timely evidence, stakeholder insight, and practical tools to modernize regulatory science and address emerging public health challenges efficiently, transparently, and in a trustworthy manner.