Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 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.

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 catalyze the translation of Artificial Intelligence (AI)-enabled, image-centered, multimodal CDS tools, developed as Software as a Medical Device, from training and testing of prototypes towards clinical applications that address unmet health challenges in precision medicine. These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This notice of funding opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO (PAR-23-286).