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Reissue RFA-NS-11-010: The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications to participate as a Data Coordinating Center in the Network for Excellence in Neuroscience Clinical Trials. This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. This FOA solicits applications for the Data Coordinating Center (DCC). Separate FOAs solicit applications for the Clinical Sites and the Clinical Coordinating Center.

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NeuroNEXT sites and potential new sites to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies for neurological disorders, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network provides a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network is not specific to one disease, it has the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. This FOA solicits applications for Clinical Sites. Separate FOAs solicit applications for the Clinical Coordinating Center and the Data Coordinating Center.

This FOA solicits the development of theories, computational models, and analytical tools to derive understanding of brain function from complex neuroscience data. Proposed projects could develop tools to integrate existing theories or formulate new theories; conceptual frameworks to organize or fuse data to infer general principles of brain function; multiscale/multiphysics models to generate new testable hypotheses to design/drive future experiments; new analytical methods to either support or refute a stated hypothesis about brain function. It is expected that the tools developed under this FOA will be made widely available to the neuroscience research community for their use and modification. Investigative studies should be limited to model parameter estimation and/or validity testing of the tools being developed.

This FOA provides support using the STTR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse lethality bioassay (MLB) as a potency assay for botulinum toxin.

The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients. The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT). A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method.

This FOA provides support using the SBIR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse lethality bioassay (MLB) as a potency assay for botulinum toxin.

The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients. The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT). A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method.

The purpose of this Notice of Special Interest (NOSI) is to stimulate dissemination and implementation research on innovative approaches built on evidence-based findings from foundational research on factors that contribute to maternal morbidity and mortality (MMM). This NOSI will support the development and implementation of strategies to inform integrated efforts involving policy and practice changes to improve preconception, pregnancy, perinatal, and postpartum care and advance maternal health and maternal health equity.

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to accelerate implementation of effective non-opioid interventions for chronic pain management in rural and remote populations. Projects include pragmatic, implementation, or hybrid effectiveness-implementation trials to improve pain management and reduce the use of inappropriate opioid medications. Awards made under this FOA will initially support a milestone-driven, planning phase (UG3) of 1 to 2 years, with possible transition to an implementation phase (UH3) of up to 4 years duration (5 years total for the two phases). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to support the "real world" implementation of effective interventions to manage pain in rural and remote areas. Results from the trials supported by this funding opportunity announcement (FOA) should inform policy makers, payers, community stakeholders, as well as health care providers and patients in the primary care, emergency department, hospital, home health, or dental setting. This FOA requires that the investigators partner with one or more rural healthcare system(s) to plan and implement the intervention. During the planning phase, investigators must develop an additional one or more community-based partnership(s). Studies may propose to integrate multi-component, bundled, or multi-level interventions that have demonstrated efficacy.

The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

The FOA is expected to be published in early 2022 with an expected application due date in Fall 2022. (from NOT-DA-21-085, TJZ 3/11/2022).