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Reissue: RFA-NS-21-024: The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

This Notice of Funding Opportunity (NOFO) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this NOFO. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this NOFO. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.

The SuRE program supports research capacity building at eligible higher education institutions bythrough funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE awards is to provide research grant support for faculty investigators at resource-limited institutions who are not currently funded by any NIH Research Project Grants (RPGs) - with the exception of SuRE or SuRE-First awards, to furnish students with high-quality undergraduate and/or graduate research experiences and to enhance the institutional scientific research culture.

The SuRE program supports research capacity building at eligible higher education institutions through funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE-First awards is to provide research grant support for faculty investigators who have not had prior independent external research grants, to furnish students with high-quality undergraduate and/or graduate research experiences and to enhance the institutional scientific research culture.

This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing and ultimately eliminating health disparities in one or more populations that experience health disparities. Appropriate technologies should be effective, affordable, and culturally acceptable.

This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing and ultimately eliminating health disparities in one or more NIH-defined populations that experience health disparities. Appropriate technologies should be effective, affordable, and culturally acceptable.

The purpose of the NIH Research Conference Grant (R13) is to support high quality conferences that are relevant to the public health and to the scientific mission of the participating Institutes and Centers.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

This BRAIN Initiative Notice of Funding Opportunity (NOFO) is to support scaled reagent production and distribution facilities involving technologies to access brain cell types. Facilities for production and distribution of these reagents by a broad and diverse set of neuroscientists will be encouraged. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project.