GREGoRi Technology Integration Center (U01, Clinical Trials 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.

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.

The Office of Population Affairs (OPA) announces the anticipated availability of funds for Fiscal Year (FY) 2027 grants under the authority of Title X of the Public Health Service Act, Section 1001 (42 U.S.C. §300).This notice solicits applications for projects to provide Title X services throughout the 50 United States, District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying Islands (Midway, Wake, et al.), the Republic of the Marshall Islands, the Federated State of Micronesia, and the Republic of Palau (hereafter, States). OPA intends to make available approximately up to $257 million for up to 90 grant awards for a period of up to five (5) years. The actual amount available will not be determined until enactment of the FY 2027 federal budget.OPA"s Title X Family Planning Program funds "voluntary family planning projects [that] offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents)." (Title X of the Public Health Service Act, 42 U.S.C. 300 et seq., available at https://opa.hhs.gov/sites/default/files/2020-07/title-x-statute-attachment-a_0.pdf). The Title X Program is implemented through competitively awarded grants to a diverse network of public and private nonprofit entities. The program helps millions of low-income and uninsured Americans develop health literacy and access family planning and related health services, empowering individuals and families to make informed decisions and navigate chronic health conditions and pregnancy with confidence. By offering counseling and education to improve individuals" optimal health outcomes, Title X promotes the level of health literacy necessary to support informed consent across the reproductive lifespan. For example, endometriosis often goes undiagnosed for years because symptoms such as severe menstrual pain or irregular bleeding are frequently normalized or minimized. Body literacy counseling helps patients recognize that these experiences are not "normal" features of womanhood, but potential indicators of an underlying condition, prompting earlier discussion with providers, timely diagnosis, appropriate treatment, and improved long-term reproductive and overall health outcomes.Likewise, foundational knowledge of reproductive physiology enables patients and couples to recognize early signs of dysfunction, seek timely evaluation, and participate meaningfully in care decisions. Persistent gaps in reproductive knowledge highlight the need for such education. For example, a survey conducted for OPA in 2020 found that only 50% of women and 38% of men know that a woman"s ovaries do not keep producing new eggs until menopause (https://opa.hhs.gov/sites/default/files/2021-01/fertility-knowledge-survey-findings-exec-summary-2020.pdf). By supporting body literacy education alongside evidence-based evaluation and treatment of chronic disease, Title X services can help patients move beyond symptom-focused care toward informed, preventive, and restorative approaches to reproductive health.These efforts align with HHS"s focus on addressing the root causes of chronic illnesses by targeting conditions that affect reproductive health and fertility. By promoting strategies that support education and counseling on reproductive health goals, reduce chronic disease, and assist individuals seeking to achieve healthy pregnancies, the Title X Program strengthens American families, individuals, and communities.This notice solicits applications from public and private nonprofit entities to establish and operate voluntary Title X projects. These projects include a broad range of effective and acceptable services, including pregnancy testing and counseling, basic infertility services, sexually transmitted infection (STI) services (such as HIV prevention education, counseling, testing, and referral), health literacy, reproductive goals counseling to increase optimal health outcomes, and other preconception health services. Title X services also help address and provide referrals for health conditions that affect fertility, including endometriosis, polycystic ovary syndrome (PCOS), and uterine fibroids in women, as well as low sperm count, low sperm motility, low testosterone, and erectile dysfunction in men. OPA seeks a broad competition for Title X grant awards and are interested in innovative strategies to address chronic disease; reduce overmedicalization by strengthening approaches focused on underlying behavioral and lifestyle factors of health and evidence-based practices such as fertility-awareness based methods; promote health and body literacy; advance reproductive goals counseling for all clients; and support family formation.All activities funded under this announcement must be in compliance with the requirements of the Title X statute, legislative mandates, and regulations. Copies of the Title X statute, regulations, and legislative mandates may be downloaded from the OPA website at https://opa.hhs.gov/grant-programs/title- x-service-grants/title-x-statutes-regulations-and-legislative-mandates.

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 Notice of Funding Opportunity (NOFO) is to catalyze the development and testing of Artificial Intelligence (AI)-enabled, image-centered, multimodal Clinical Decision Support (CDS) tools, developed in pursuance as Software as a Medical Device (SaMD). 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), 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 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).