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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 (DS). This Notice of Special Interest (NOSI) announces NIH support for exploratory/developmental grant (R21) applications that are focused on community-based participatory research (CBPR) in DS to address health disparities and that meet programmatic objectives for the INCLUDE Project. Individuals with DS experience greater health disparities than the general population. These disparities in the DS community stem from disparities in healthcare services including receiving preventive services and access to quality care. Although the lifespan of individuals with DS has increased dramatically in the last few decades, the racial disparities in life expectancy are glaring. The median age of survival for Blacks and other racial groups falls way behind that of individuals with DS who are White although the prevalence of DS among all racial groups is about the same. Hence, it is important to understand the social determinants of heath (race, ethnicity, age, geography, and socioeconomic status) that lead to such disparities in the DS population. The Healthy People 2030 initiative [United States Department of Health and Human Services, 2030; https://health.gov/healthypeople] has also added Social Determinants of Health as a new objective to reduce health disparities and increase efforts to improve the health and well-being for all. To fully engage and understand the various factors (social, environmental, economic) contributing to health disparities in those with DS, we encourage collaboration and partnership among DS community members (those with DS, family members, self-advocates, and advocates) as well as various key stakeholders (scientists, clinicians, policy makers, educators) to propose projects that address these issues.

This Notice of Special Interest (NOSI) encourages the translation of the novel neurotechnologies, funded through the Helping to End Addiction Long-Term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical validation for subsequent clinical feasibility studies. Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

This funding opportunity announcement (FOA) encourages early-stage development of novel small molecule or biologic therapeutics for NINDS mission-relevant? Alzheimer's and related dementias: frontotemporal degeneration (FTD, including Picks disease and progressive supranuclear palsy), Lewy body dementias (LBD; including dementia with Lewy bodies (DLB) and Parkinsons disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), and multiple etiology dementias (MED). This FOA covers four stages of early therapy discovery/development with each stage gated by go/no-go milestones. Applicants may enter the program at the stage appropriate to their research. The R61 phase supports preparatory research stages 1 -3: 1) development of in vitro and/or ex vivo assays that can support therapeutic screening efforts, 2) screening efforts to identify and characterize potential therapeutic agents, and 3) therapeutic optimization, pharmacodynamic and pharmacokinetic studies. The R33 phase supports stage 4, in vivo efficacy studies in an animal model of disease. This FOA supports research to enable competitive follow-on applications that meet the entry criteria for the Blueprint Neurotherapeutics Network, Blueprint Biologics, or other similar later-stage translational programs.

More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance in the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative pain treatment options are thus critically needed. Through targeted research efforts, the NIH HEAL Initiative aims to support the development of safe and effective devices to treat pain with little or no addiction liability. This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PD/PIs to investigate the mechanism of action of pain relief by medical devices with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies. Program teams are expected to accomplish goals that require considerable synergy and collaborative interactions. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider objectives that will produce major advances in the field of pain relief by medical devices.

This Notice of Special Interest (NOSI) is being issued by the National Center for Complementary and Integrative Health (NCCIH) with participation from multiple NIH Institutes, Centers, and Offices (ICOs). This NOSI aims to promote mechanistic research of therapeutic benefits of minor cannabinoids and terpenes in the cannabis plant. Minor cannabinoids are defined as any and all cannabinoids from the cannabis plant other than ?9-tetrahydrocannabinol (?9-THC). Cannabinoids of particular interest include the following: ?8-THC, Cannabidiol (CBD), Cannabigerol (CBG), Cannabinol (CBN), Cannabichromene (CBC), cannabichromevarin (CBDV), tetrahydrocannabivarin (THCV), Tetrahydrocannabivarin acid (THCVA), tetrahydrocannabinolic acid (THCA), carmagerol, cannabicitran, sesquicannabigerol. Terpenes of particular interest include the following: Myrcene, -caryophyllene, Limonene, ? -terpineol, Linalool, ?-phellandrene, ?-pinene, -pinene, ?-terpinene, and ?-humulene. This NOSI intends to support highly innovative basic and/or mechanistic studies in appropriate model organisms and/or human subjects aiming to investigate the impact of minor cannabinoids and terpenes on mechanisms underlying their therapeutic effects. Preclinical studies of combinations of minor cannabinoids with terpenes or other natural products that may enhance their therapeutic benefits and/or abate unwanted effects are encouraged.

The accumulation of misfolded proteins in the brain is a key pathological feature shared by many neurodegenerative diseases that can result in dementia such as Alzheimers Disease, Lewy Body Diseases, Frontotemporal Degeneration, and cerebral amyloid angiopathy. Classical prion diseases such as Creutzfeldt-Jakob Disease are a rare family of neurodegenerative disorders that occur when the cellular prion protein (PrPC) undergoes structural conversion to a pathological form (PrPSc), which is usually triggered by its interaction with an infectious variant of the protein that forces the conformational change. Once this process is initiated, it becomes self-propagating until toxic aggregates accumulate within the CNS, leading to neuronal death. Because misfolded proteins of AD/ADRD have been reported to share some features with pathological prion protein at the structural level, it has thus been proposed that ADRD-relevant proteins such as Alpha, tau, beta-synuclein, and TDP-43 (among others) may exhibit prion-like behaviors that lead to toxic aggregate and tangle formation. The goal of this initiative is to promote studies that increase our understanding of the cellular and molecular mechanisms by which such prion-like conversion events occur and are propagated in AD/ADRD, as well as the downstream mechanisms that trigger neurotoxicity, pathological and circuit changes in the brain.

The purpose of this Limited Competition Funding Opportunity Announcement is to allow Undiagnosed Diseases Network (UDN) Clinical Sites that received an NIH award under RFA-RM-17-019 an opportunity to compete for one additional year of NIH funding to: continue their participation in the UDN; establish collaborations and efficient processes with the next phase Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and further develop their sustainability plans.

The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.

Emergency Award: This Funding Opportunity Announcement (FOA) solicits research applications that propose implementation science methodology to embed existing evidence-based coordinated pain care models into a variety of public and private health care systems (HCS) where this type of care does not exist. Applications that combine comparative effectiveness studies of innovative coordinated care models with strong implementation science methodology to embed effective approaches into HCSs also are encouraged. This FOA requires that the coordinated care model under study be embedded into the health care delivery system of the applicant institutions. Coordinated pain care approaches proposed for study should include interventions from multiple disciplines as described below and should aim to improve pain management based on the biopsychosocial model of pain. Emphasis should be on populations of patients with greatest need. This FOA solicits applications from HCS who have resources and infrastructure to support research and implementation of study approaches in partnership with those HCS who lack research resources or experience and would benefit most from implementation of cost-effective coordinated pain care. HCS partners who serve populations that are under-represented in research are encouraged to apply. Models of coordinated care proposed by the study team should be aligned with health care resources of the participating HCS and should be informed through engagement of stakeholders including patients, providers, healthcare system executives, policy makers, and payors. The study teams must include health care providers from multiple disciplines and implementation scientists.

This FOA invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRDs). This FOA seeks to promote critical target validation approaches to help de-risk subsequent translational research and accelerate the advancement of novel therapies for ADRD. Target(s) or molecular pathway(s) to be considered for validation must have been already identified using tissue expression or genetic data generated in human samples. In its initial phase, this FOA provided support for up to two years (R61 stage) for the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) in cells or tissues and monitor their functional biological consequences in in vitro or in vivo disease models. Upon demonstration of technical feasibilities, a second phase (R33 stage) will carefully and reproducibly measure and cross-validate the impact of the target modulation in different modalities across collaborating laboratories using the NIH rigor and reproducibility guidelines. Applicants responding to this FOA must address objectives for both the UG3 and UH3 phases and are expected to have a substantial collaborative effort between independents laboratories. This FOA is not specific for any one or group within the ADRD spectrum of disorders. Disorders covered in these applications are frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), mixed dementias including the associated diagnostic challenges of multiples etiology dementias (MED).