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The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this Notice of Special Interest (NOSI) to encourage applications proposing to test multilevel strategies and interventions to improve the uptake of evidence-based screening services across the lifespan and in diverse populations including, but not limited to, those experiencing health disparities and those that have been underserved.

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within the scope of the mission of one of the Institutes/Centers listed above.

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within the scope of the mission of one of the Institutes/Centers listed above.

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within the scope of the mission of one of the Institutes/Centers listed above.

The COVID-19 pandemic continues to be the source of much mortality and morbidity creating and contributing to both physical and mental health issues. Recent data suggest that over 825,000 individuals have died from COVID-19 in the United States including over 8600 deaths in the week ending January 5, 2022.However, the impact of the SARS-CoV-2 virus as well as the associated measures to prevent and treat this infection extend well beyond the issue of mortality. Although much needed information regarding the epidemiology, transmission and potential acute treatments including the development of an effective vaccine have been gleaned in unprecedented time, important issues remain to be elucidated including, but not limited to the effect of the virus and its therapy on menstrual health, fertility and the offspring of infected and/or vaccinated parents, the impact of the relatively recent Delta and Omicron variants and other emerging variants, the occurrence of viral co-infections and the many physical and mental health issues created by the pandemic itself.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This FOA is intended to support meritorious small research projects focused on analyses of genomics other -omics, clinical and phenotypic datasets related to Down syndrome research, with an emphasis on elucidating the underlying etiologies of risk and resiliencies to co-occurring health conditions. Development of approaches, tools, or algorithms appropriate for analyzing data relevant to Down syndrome and facilitating data sharing within the research community through the INCLUDE Data Hub may also be proposed.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Funding Opportunity Announcement (FOA) is soliciting Transformative Research Award applications to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research that has the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies related to Down syndrome. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the nations research workforce. Individuals from diverse backgrounds, including those from underrepresented groups and from the full spectrum of eligible institutions in all geographic locations are strongly encouraged to apply to this Funding Opportunity Announcement. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Funding Opportunity Announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. This initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.