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The purpose of this Notice of Special Interest (NOSI) is to encourage applications to PA-20-272 to integrate neuroethics perspectives and approaches into existing BRAIN Initiative awards.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) for Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic, and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs). The DCC will have responsibility for data management, data quality, statistical analysis, Data Safety Monitoring Board(s) (DSMB) and reporting to regulatory and oversight groups. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical Coordinating Center (CCC) of Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs). The CCC will facilitate implementation of clinical trials and will promote high quality and efficient timeliness in trial execution through such methods as master trial agreements and a central Institutional Review Board. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

(Reissue of RFA-NS-16-016) The purpose of this funding opportunity announcement (FOA) is to invite applications from new and existing sites to serve as Clinical Centers (Hubs) in the SIREN Network. SIREN conduct of several multi-center Phase III clinical trials, to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic, and traumatic conditions. SIREN is made up of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and 11 clinical centers (Hubs). A Hub is usually an academic center or tertiary referral center which actively enrolls patients into all of the clinical trial performed in SIREN. Hubs also provide scientific leadership and administrative oversight to their multiple satellite sites ("Spokes"). Together the Hub and Spokes provide access to a large and varying patient population for clinical trials. SIREN performs a number of simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials are meritorious, peerreviewed projects which are awarded under separate funding announcements.

This FOA invites applications from multidisciplinary teams to perform secondary data analysis, using existing datasets from two or more multi-site clinical research projects, to address scientific and clinical hypotheses relevant to neurological disorders and conditions within the NINDS mission. In this phased funding mechanism, applications are required to systematically and comprehensively perform cross-project data harmonization and curation, assessed using Go/No-go data-quality metrics, prior to funding of the second phase of data analyses. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, this funding opportunity expects open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as controlled access to the curated datasets.

The National Institutes of Health (NIH) intends to support the development of innovative quantitative imaging and other relevant biomarkers of myofascial tissues for pain management involving research participants using a two-phase grant funding mechanism. This effort is part of NIHs Helping to End Addiction Long-term (HEAL)SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. This funding opportunity announcement (FOA) seeks research applications to develop quantitative imaging biomarkers of myofascial tissues and assess their abilities to monitor responses and/or predict outcomes of a variety of pain management regimens. Candidates for the quantitative imaging biomarkers may include objective measures based on minimally invasive imaging technologies, electrophysiological recordings, integration of multiparametric imaging and electrophysiology approaches, or their integration with other markers (e.g., immune factors, genomic markers, physiological factors, etc.) through multiscale modeling or machine learning analysis. The first phase, funded by the R61, will provide funding for up to three years to develop quantitative measures that can differentiate myofascial tissue abnormalities in healthy versus latent, versus active myofascial pain stages using cross-sectional correlations with clinical signs/symptoms. In addition, the R61 phase should include team building and planning activities for the R33 phase. The second phase, funded under the R33, will provide up to two years of support to assess the abilities of the quantitative measures developed in the R61 phase to monitor responses and/or predict outcomes in response to specified therapies to relieve myofascial pain in longitudinal interventional studies.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for projects to transfer technology out of the NIH intramural research labs into the private sector. If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public.

The purpose of this FOA is to provide investigators with a mechanism to access contract research/medical organizations (CROs/CMOs) and subject matter experts (SMEs) within the NINDS Ultra-Rare Gene-based Therapy (URGenT) Network to support planning, manufacturing, and limited nonclinical therapeutic development efforts.

The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this funding opportunity announcement (FOA) is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial.

The purpose of this FOA is to develop and use models to investigate the contribution of synaptic activity and circuit plasticity changes to the progression of disease processes that underlie neurodegeneration in dementia. The overall goal is to understand, from a mechanistic standpoint, the earliest synaptic, circuit and network changes that contribute to AD/ADRD disease onset and pathogenesis. A better in vivo mechanistic understanding of synaptic activity and circuit plasticity changes that underlie the earliest stages of neurodegeneration in AD/ADRD should increase opportunities for developing future interventions. Utilizing technology developed in NIH BRAIN programs is encouraged, including animal-based studies that validate in vivo relevance of findings based on cell-based or organoid-based research. Applications that rely entirely on cell-based or organoid-based systems are out of scope.