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Understanding the dynamic activity of brain 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 recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). This FOA seeks exceptionally creative approaches to address major challenges associated with recording and modulating CNS 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. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, magnetic, acoustic and/or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications that bring together transdisciplinary teams and aim to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution objective measurement of behavior at the organismal level, with synchronous capture of dynamic environmental data; 2) develop advanced analytic approaches to integrate multidimensional behavioral, neural and environmental data; and 3) develop and test new theoretical and computational models aiming to advance understanding of behavior as a complex dynamic system. Proposed projects are expected to be designed with the capacity to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. This BRAIN Initiative NOFO is specifically soliciting applications proposing basic research involving human subjects aiming to reveal and understand fundamental principles underlying behavioral function, including research limited to observational studies or analysis of human data. Applications proposing research using exclusively non-human animal models should apply under the companion NOFO, RFA-DA-24-041. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP).

This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications proposing research aiming to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the organismal level, with synchronous capture of changes in the organisms social or physical environment; and 2) develop computational methods that allow for integration of multidimensional behavioral and environmental data representing multiple timescales into a conceptual and/or computational model of behavior as a complex dynamic system. Proposed projects are also expected to be designed with the capacity to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. Research that falls under the definition of an NIH Clinical Trial is not allowed under this NOFO. Applicants interested in proposing mechanistic research in humans relevant to the above purpose should submit under the companion U01 NOFO, RFA-DA-24-040. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Reissue: RFA-NS-21-023 - 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, 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.

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.

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.

Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.0 Neuroethics Subgroup, this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.0 Neuroethics Subgroup, this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.