Notices of Funding Opportunities

This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” this FOA specifically seeks to support efforts that will revolutionize our understanding of the biological activity underlying, and bioinformatic content of, data collected using contemporary non-invasive functional brain imaging techniques. The hope is that these transformative discoveries will lead to breakthroughs in understanding the dynamic activity of the human brain.

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.

This FOA is intended to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices that are FDA-designated as Class III (invasive, posing significant risk of harm), to conduct clinical research in the central nervous system.As part of The BRAIN InitiativeSM, NIH has initiated a Public-Private Partnership program (BRAIN PPP) to reduce barriers to negotiating such partnerships, and to ensure that new clinical studies leverage manufacturers existing data demonstrating safety and utility of these devices.Safety and utility data for invasive devices are costly to obtain, yet they are necessary for regulatory approval of human research, and therefore pose a substantial barrier to research progress.For this program, NIH has entered into agreements with a number of manufacturers to make available next generation devices that can stimulate and/or record from the central nervous system and have sufficient data to enable new Non-Significant Risk (NSR) or Investigational Device Exemption (IDE) without the need for significant additional testing.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators 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 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.

700 To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development. This FOA will support short courses to facilitate the development of a sophisticated cadre of investigators with the requisite knowledge and skills in computational neuroscience perspectives and techniques for analyzing and interpreting complex, high-dimensional neuroscience data to advance The BRAIN Initiative®. For the purposes of this FOA, computational neuroscience encompasses theoretical neuroscience, computational and mathematical modeling of neural systems, and/or statistical perspectives and techniques. Each short course is expected to include both didactics and in-person/hands-on experiences. This FOA is intended for participants who are graduate students, medical students, postdoctoral scholars, medical residents, and/or early-career faculty.

This FOA solicits new theories, computational models, and statistical methods to derive understanding of brain function from complex neuroscience data. Approaches could include the creation of new theories, ideas, and conceptual frameworks to organize/unify data and infer general principles of brain function; new computational models to develop testable hypotheses and design/drive experiments; and new mathematical and statistical methods to support or refute a stated hypothesis about brain function, and/or assist in detecting features in complex brain data.

In this Funding Opportunity Announcement (FOA) we seek applications through the Small Business Innovation Research (SBIR) program for the optimization of existing and emerging technologies and approaches including 1) technologies and novel approaches for large scale recording and manipulation of 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, 2) tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. This FOA is intended for the iterative refinement of emergent technologies and approaches that have already demonstrated their transformative potential through initial proof-of-concept testing, and are appropriate for accelerated development with an end-goal of broad dissemination and incorporation into regular neuroscience practice.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications 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 FOA is to encourage applications 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 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, 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research including 1) tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function, 2) proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of 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, and 3) iterative refinement of such tools and technologies with the end-user community with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice. Application Receipt Date(s): Standard Dates Apply