Notices of Funding Opportunities

The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.

The purpose of this announcement 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.

The purpose of this announcement 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

This NOFO solicits applications for next generation sensor and bioelectronic device development that will synchronize with brain recordings. The sensor and neural recording data will be used to generate new computational models of behavior in human and animal models. There has been a lack of quantitative approaches and models to understand the complexity of human and animal behavior in naturalistic settings. This NOFO focuses on the development of next generation sensors to acquire data and synchronize it with simultaneous brain recordings to build computational models.

This Notice of Funding Opportunity Announcement (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support establishment of facilities at minority-serving institutions (MSIs) and Institutional Development Award (IDeA)-eligible institutions for scaled production and distribution of brain cell type-specific access and manipulation reagents. Reagents will be initially developed in pilot resource projects for brain cell type-specific access and manipulation across vertebrate species from the BRAIN Initiative Armamentarium project. Awardees under this NOFO will work with the other Armamentarium awardees to manufacture and distribute the resources for use throughout the neuroscience community. It is envisioned that the awardees will work both with the Armamentarium community as well as with the neuroscience research community to optimize the use of new reagents. The types of reagents to be produced and distributed could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. Such reagents will enable neuroscientists to probe circuit function with high precision in experimental animals and ex vivo human tissue and cells. Facilities are needed to contribute to the production and distribution of BRAIN Initiative Armamentarium project reagents broadly to neuroscience users.

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.