Sustained Support for Informatics Technologies for Cancer Research and Management (U24 Clinical Trial Optional)

The focus of this notice of funding opportunity (NOFO) is to produce insights into disease detection and prevention strategies, burden, severity, diagnostics, treatment, and outcomes of infectious diseases in international travelers. Timely surveillance and sentinel detection are essential for collecting actionable data. The research should:Address public health questions that improve the speed of outbreak detection.Help develop guidelines and recommendations to improve patient care.Enhance understanding of the natural history of disease.Optimize genomic surveillance as well as diagnostic and treatment strategies.Advance the global health security of the United States.This NOFO will have two components:Component A – Clinic-based sentinel network.Component B – Sentinel detection in international transportation hubs.You may apply for Component A, B, or both. If your application for both Component A and B is ranked top, Component B will be awarded.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Technology Integration Center, which will enable the development of standards and best practices for applying new and emerging molecular methods in rare disease diagnosis. A major deliverable of the Center will be a multidimensional dataset that can be used for the development and benchmarking of novel tools and strategies that facilitate rare disease diagnosis.

NIOSH is encouraging the submission of an application from qualified organizations for a National Center for Construction Safety and Health Research and Translation. Applicants are encouraged to propose multidisciplinary approaches and coordination for impactful applied and intervention research, hazard identification, and controls; develop partnerships for implementing prevention and intervention activities; and serve as a leader in research translation and research-to-practice for the protection of construction workers in the U.S. The Center will accomplish these goals by integrating and advancing research, research translation, best practices, policy and guidance, and capacity building. Center work should consider the NIOSH strategic plan and NORA construction research objectives. Center structure should take advantage of diverse scientific resources and focus on national worker safety and health issues. Centers should emphasize the creation and implementation of evidence-based solutions that address important construction industry safety and health problems. Collaborations with other academic institutions, nonprofit organizations, and other occupational safety and health-focused groups are expected. Applicants must concisely describe the occupational health burden of important safety and health issues in the construction industry and discuss how focused research and outreach activities will help alleviate the burden and reduce numbers. Applicants should also clearly articulate the anticipated impacts of the Center’s proposed work, both during the project period and beyond.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the creation of a Validation Center to serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal CDS tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible, and generalizable. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the program. The core functions of the Validation Center will involve the systematic validation of PRIMED-AI Consortium deliverables, including those emerging from award recipients under the Playbook, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic NOFOs.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.

The NOFO supports CDC"s efforts to protect U.S. residents traveling internationally. The goal is to help U.S. travelers with pre-travel preparation, access to timely health information while traveling, and timely research on health conditions.The project will:Improve access to high quality travel preparation information for both healthcare providers and travelers.Collect health information before, during, and after travel through innovative electronic medical record (EMR), web, and mobile phone applications.Build on this platform to conduct timely research on emerging health threats.This NOFO will also increase the awareness of travel medicine among primary care providers and provide them with appropriate tools in advising international travelers with up-to-date recommendations.

NIMH seeks applications for pilot research to adapt, optimize, and test behavioral interventions that address common sleep problems in adolescents and young adults with or at risk for a mental health disorder. This notice of funding opportunity (NOFO) supports pilot clinical trials designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach in real world settings. Applications should aim to conduct a preliminary test of the intervention's impact on sleep and mental health outcomes, as well as an examination of the mechanisms that underlie the intervention's effectiveness, and to obtain preliminary data needed as a prerequisite for larger-scale effectiveness trials. In addition, interdisciplinary, collaborative teams of investigators from the fields of mental health, sleep medicine, developmental science, clinical trials research methods, behavioral economics, implementation science, data science, and human computer interaction are encouraged.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist.

The goal of this NOFO is to support applications for novel theory and methods development that enable better understanding of how genetic and non-genetic factors contribute to complex trait variation across individuals, families, and populations. Approaches should be interdisciplinary drawing from the natural and social sciences, account for interdependencies across scales of biological, social, and ecological organization, and make extensive use of theory, modeling, and validation with available large-scale datasets.

This Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) PAR, a re-issue of PAR-24-035, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplify Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.