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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).

The goal of this initiative is to study the role of epigenetic mechanisms regulating HIV CNS (central nervous system) latency and neuropathogenesis in brain derived cells such as macrophages, microglia and astrocytes using novel single cell technologies. Thus this FOA will encourage studies of the role of epigenetic mechanisms regulating HIV CNS latency and neuropathogenesis in brain derived cells such as macrophages and microglia using novel single cell technologies.

The goal of this initiative is to study the role of epigenetic mechanisms regulating HIV CNS (central nervous system) latency and neuropathogenesis in brain derived cells such as macrophages, microglia and astrocytes using novel single cell technologies. Thus this FOA will encourage studies of the role of epigenetic mechanisms regulating HIV CNS latency and neuropathogenesis in brain derived cells such as macrophages and microglia using novel single cell technologies.

This Funding Opportunity Announcement (FOA) solicits applications for team-centric development and validation of innovative non-invasive imaging technologies that could have a transformative impact on the study of brain function/connectivity. Applications are expected to turn a novel concept into a functional prototype using this phased grant mechanism. The feasibility should be established by the end of its first phase and serve as a foundation for the transition to its second phase. Fully developing the technology into a functional prototype and validating it by in-vivo animal or human function/connectivity imaging are anticipated in the second phase. The research plan should provide a realistic timeline and tangible milestones to support the proposed development effort. Awards will be integrated into the BRAIN Non-Invasive Imaging Consortium, as a coordinated network on brain function/connectivity imaging.

This funding opportunity announcement (FOA) seeks applicants experienced in the isolation and sequencing of RNA from brain-derived extracellular vesicles to develop a research resource for the Accelerating Medicines Partnership in Parkinson's Disease (AMP PD). Approximately 2400 blood samples will be provided for this project from existing Parkinson's disease and normal control cohorts that already have longitudinal clinical and sequencing data that is publicly available to interested researchers. It is intended that this resource will become a part of the AMP PD Knowledge Platform, where it will be broadly shared with the research community.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seek highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications will be required to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.

The participating Institutes and Centers (ICs) are inviting applications to expand existing awards that are not currently focused on Alzheimers disease and its related dementias (AD/ADRD)frontotemporal dementia, Lewy body dementia, Vascular Contributions to Cognitive Impairment and Dementia (VCID), and multiple etiology dementiasto allow the research to develop such a focus. Active awards with project end dates in FY 2024 or later are eligible. The award may not be in a terminal no-cost extension or going into a no-cost extension in FY 2023. Please note that a few ICs limit no-cost extensions in the final non-competing year of an award. For that reason, it is important to contact staff at the Institute supporting the award when planning the request.

The purpose of the initiative is to utilize the cohort study design to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This FOA is for clinical/community field centers (CCFCs), and a companion one will solicit for the coordinating center (CC).

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator- initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.