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The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility Study). The small clinical study 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 study is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and thereby 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 study 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 study 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 study to answer key questions about the function or final design of a device.

Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative. This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for largescale recording and manipulation of neural activity to enable transformative understanding of dynamic signaling in the nervous system. In particular, we seek exceptionally creative approaches to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high-risk, but if successful could profoundly change the course of neuroscience research.

The purpose of this FOA is to solicit applications that propose basic and/or translational research studies regarding the developing neurovascular unit, perinatal stroke injury/repair response, and/or stroke related etiologies and risk factors. Research addressing vascular, hemostatic, hematopoietic, and/or immune cell activities in the developing brain is of particular interest. The intent is to stimulate research that will identify therapeutic targets in perinatal stroke.

This Funding Opportunity Announcement (FOA) solicits applications to develop standards that describe experimental protocols that are being conducted as part of the BRAIN Initiative. It is expected that applications will solicit community input at all stages of the process. It is recommended that the first step of standard development will involve sharing data between different key groups in the experimental community in order to ensure that the developing standard will cover the way that all of those groups are collecting data. The developed standard is expected to be made widely available.

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty and the research base at institutions with an explicitly stated historical mission and/or a demonstrated historical track record of training and graduating students from backgrounds underrepresented in biomedical research. Eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received less than 6 million dollars per year of NIH R01 support (total costs) in each of the last 2 fiscal years.

This Funding Opportunity Announcement (FOA) solicits applications to develop informatics tools for analyzing, visualizing, and integrating data related to the BRAIN Initiative or to enhance our understanding of the brain.

This funding opportunity announcement (FOA) supports high impact efforts to make resources available to neuroscience researchers. Projects should engage in one or more of the following activities: facilitating access to cutting edge reagents or techniques, dissemination of resources to new user groups, or innovative approaches to increase the scale/efficiency of resource production and delivery. Applications focused primarily on technology or software development are not responsive to this FOA, as the focus is on dissemination or provision of resources. Use of existing technologies to develop new reagents or genetic lines of significant value to the research community may be appropriate. Projects should address compelling needs of broad communities of neuroscience researchers or should offer unique services that otherwise would be unavailable. Projects must support the NINDS mission.

This Funding Opportunity Announcement (FOA) 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 FOA. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this FOA. 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 SCORE Program is a developmental program designed to increase the research competitiveness of faculty and research capacity of institutions with an explicitly stated historical mission and/or a demonstrated historical track record of training and graduating students from backgrounds underrepresented in biomedical research. Eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received less than 6 million dollars per year of NIH R01 support (total costs) in each of the last 2 fiscal years.