Notices of Funding Opportunities

Reissue of RFA-NS-18-020: 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.

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.

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

This is a reissue of RFA-MH-19-136. 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.

Reissue of RFA-NS-19-011: The purpose of the NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award is to support a defined pathway across career stages for outstanding graduate students who are from backgrounds that are nationally underrepresented in neuroscience research. This two-phase award will facilitate completion of the doctoral dissertation and transition of talented graduate students to strong neuroscience research postdoctoral positions, and will provide career development opportunities relevant to their long-term career goal of becoming independent neuroscience researchers.

The purpose of this Notice is to inform interested applicants that the expiration date in PAR-18-205 " NIBIB Biomedical Technology Resource Centers (P41 Clinical Trials Optional)" will be extended by one receipt cycle (See changes in bold italics below). Part 1. Overview Key Dates Currently Reads: Expiration Date January 8, 2021 Modified to Read: Expiration Date May 8, 2021 All other aspects of this FOA remain unchanged.

This Funding Opportunity Announcement (FOA) 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 FOA 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.

(Reissue of RFA-NS-18-014) This R34 FOA solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted Brain Circuits Projects - TargetedBCP R01, as described in the companion FOA (RFA-NS-18-009). Applications should be exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.

(Reissue of RFA-NS-18-030) This FOA solicits applications for research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior. The goal is to support projects that can realize a meaningful outcome within 5 years. Applications should address circuit function in the context of specific neural systems such as sensation, perception, attention, reasoning, intention, decision-making, emotion, navigation, communication or homeostasis. Projects should link theory and data analysis to experimental design and should produce predictive models as deliverables. Projects should aim to improve the understanding of circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating dynamic patterns of neural activity. Projects can use non-human and human species, and applications should explain how the selected species offers ideal conditions for revealing general principles about the circuit basis of a specific behavior.

This is a reissue of RFA-MH-20-120. This FOA invites applications that will conduct secondary analysis or data mining of existing data relevant to the BRAIN Initiative goal of understanding brain circuits. The FOA also invites applications that seek to prepare and submit existing data that are highly relevant to the BRAIN Initiative into one of the BRAIN Initiative data archives. Applications can propose to generate or test new hypotheses which would not be possible in studies of single experiments, single technologies or single laboratories, or were beyond the scope of the original studies. Applications that propose to reanalyze existing data sets using new tools or approaches are also welcome. The proposed research may involve innovative analyses of existing data or novel combination or integration of existing data sets to address new aims or explore new questions.