Over the next several years, the FAS Research Development group will track and disseminate all funding opportunities related to the BRAIN Initiative. These funding opportunities will be sent to a targeted list of faculty. That list includes faculty affiliates of the Center for Brain Science (CBS) and the Mind Brain Behavior (MBB) Interfaculty Initiative. This project is being carried out in collaboration with the Center for Brain Science. All opportunities will be archived and recipients may unsubscribe at any time. For additional Research Development support (finding funding, proposal development resources, etc.), please visit the Research Development website.
Funding Opportunities
Sponsor Deadline for Letters of Intent (requested): 30 days prior to the deadline
Sponsor Deadlines for Full Proposals: December 21, 2016 and October 18, 2017
OSP Deadline: December 14, 2016 and October 11, 2017 
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Awards are for three years of support. The NIH anticipates providing $9M per year to fund an estimated 15 to 20 awards.
 
Understanding the dynamic activity of neural 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 large-scale recording and manipulation of neural activity to enable transformative understanding of dynamic signaling in the nervous system.  In particular, NIH seeks exceptionally creative approaches to address major challenges associated with recording and manipulating 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.  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, and should include advancements that enable or reduce major barriers to hypothesis-driven experiments.  Technologies may engage diverse types of signaling beyond neuronal electrical activity for large-scale analysis, and may utilize any modality such as optical, electrical, magnetic, acoustic or genetic recording/manipulation.  Applications that seek to integrate multiple approaches are encouraged.  Where appropriate, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.   

Sponsor Deadline for Letters of Intent (requested): 30 days prior to the deadline
Sponsor Deadlines for Full Proposals: December 21, 2016 and October 18, 2017
OSP Deadlines: December 14, 2016 and October 11, 2017 
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Awards are for three years of support. The NIH anticipates providing $9M per year to fund an estimated 15 to 20 awards.
 
Although invention and proof-of-concept testing of new technologies are a key component of the BRAIN Initiative, to achieve their potential these technologies must also be optimized through feedback from end-users in the context of the intended experimental use. This FOA seeks applications for the optimization of existing and emerging technologies and approaches that have potential to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and temporal scales, in any region and throughout the entire depth of the brain.  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 of hardware and software while scaling manufacturing techniques towards sustainable, broad dissemination and user-friendly incorporation into regular neuroscience practice.
 
Proposed technologies should be compatible with experiments in behaving animals, and should include advancements that enable or reduce major barriers to hypothesis-driven experiments.  Technologies may engage diverse types of signaling beyond neuronal electrical activity for large-scale analysis, and may utilize any modality such as optical, electrical, magnetic, acoustic or genetic recording/manipulation.  Applications that seek to integrate multiple approaches are encouraged.  Applications are expected to integrate appropriate domains of expertise, including where appropriate biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

OSP Deadlines: December 14, 2016 and October 11, 2017 
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Budgets should rarely exceed $2M. The duration of the UG3 phase cannot exceed 4 years and the total duration of the UG3/UH3 phases combined may not exceed 5 years. The NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards.
 
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. 

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/. Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or RFA-NS-17-006.

Sponsor Deadlines: December 21, 2016 and October 18, 2017
OSP Deadlines: December 14, 2016 and October 11, 2017 
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Budgets should rarely exceed $2M. The total duration may not exceed 5 years. The NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards.
 
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.

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/. Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-17-005 or this FOA.

Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Applications should rarely exceed $1,000,000 in total cost per year during the Phase I and $1,500,000 in total costs per year during the Phase II. Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested. NIH intends to commit up to $6,500,000 in FY2017 to fund approximately 5 awards.
 
The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain.  The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical study (e.g., Early Feasibility Study).  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 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 non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.  

Sponsor Deadlines: December 21, 2016 and October 18, 2017
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Applications should rarely exceed $1,500,000 in total costs per year for Phase II. Durations up to 3 years for Phase II may be requested. NIH intends to commit up to $6,500,000 in FY2017 to fund approximately five awards.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) 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 thereby 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.      

Additional Information
Questions about this newsletter or proposal submission may be directed to:

Jennifer Corby
Research Development Officer
jcorby@fas.harvard.edu | 617-495-1590

To see previous BRAIN Initiative Funding Newsletters, please visit our email archive.
Research Development | Research Administration Services | research.fas.harvard.edu