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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.

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.

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: propagation of 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 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 clear value 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.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.The over-arching goal of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.

The NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity is designed to enhance the participation of highly trained early career investigators from diverse backgrounds underrepresented in neuroscience research. This opportunity provides individuals from diverse backgrounds with strong training in neuroscience with the resources and tools that will help facilitate a transition to a stable and productive independent (i.e., non-mentored) research position. Individuals from diverse backgrounds underrepresented in neuroscience research are eligible for support under this award if they have doctoral research degrees (Ph.D., P.h.D./M.D. or equivalent) and between 2 and 5 years of postdoctoral prior research training at the time of application.

The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative Funding Opportunity Announcement (FOA) is to encourage the transfer of new technologies and new data analysis techniques into a research laboratory. One of the key goals of the BRAIN Initiative is to develop new technologies to improve our understanding of the brain. In order for those technologies to be useful, they need to be broadly disseminated beyond the laboratory or company where they originated. This FOA promotes this goal by providing funds to enable the incorporation of new technologies or data analysis techniques into research programs that further the aims of the BRAIN initiative.

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project.Administrative supplements must support work within the scope of the original project.

The Office of Research on Womens Health (ORWH) and participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) announce the continuation of the program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after an interruption for family responsibilities or other qualifying circumstances. The purpose of these supplements is to encourage such individuals to re-enter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals to update their existing research skills and knowledge.

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.It is expected that the approaches developed under this FOA will be made widely available to the neuroscience research community for their use and modification.