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.

UH2National Institutes of Health
BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3)
Full Proposal Deadline: April 14, 2015 by 5pm
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants should rarely exceed $1M direct costs per year for the non-clinical testing phase and $1.5M direct costs per year for the Early Feasibility Study phase. The duration of the UH2 phase cannot exceed 3 years and the total duration of the UH2/UH3 phases combined may not exceed 5 years. 

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications 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 milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions. NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic. The expectations of the program are in line with those of industry in regards to advancing devices through the translational developmental pipeline. As such, an inherent high rate of attrition is expected within this program. 

An additional companion BRAIN FOA (see below) is anticipated to fund projects that are sufficiently developed to move directly to the UH3 clinical studies. 

UH3National Institutes of Health
BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3)
Full Proposal Deadline: April 14, 2015 by 5pm
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants should rarely exceed $1.5M direct costs per year. The total duration of the project may not exceed 5 years.

The purpose of this FOA is to encourage applications 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, 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

This FOA is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions. NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic. The expectations of the program are in line with those of industry in regards to advancing devices through the translational developmental pipeline. As such, an inherent high rate of attrition is expected within this program.

A companion FOA (see above) will support non-clinical testing required to obtain the necessary approvals to conduct the clinical study, in addition to a singular clinical study. 

R44National Institutes of Health
BRAIN Initiative: Optimization of Novel Tools and Technologies for Neuroscience Research (R44)
Full Proposal Deadline: April 28, 2015 by 5pm
Award Information: According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($1,500,000 for Phase II). As written in the statute and under appropriate circumstances, NIH can apply for a waiver from SBA to issue an award exceeding $1,500,000 for Phase II, if this cap will interfere with NIH's ability to meet its mission. Applicants should propose a budget that is reasonable and appropriate for completion of the research project. Durations up to three years for Phase II may be requested. 

In this Funding Opportunity Announcement (FOA), NIH seeks applications through the Small Business Innovation Research (SBIR) program for the optimization of existing and emerging technologies and approaches including 1) technologies and novel approaches for large scale recording and manipulation of 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, 2) tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. 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 with an end-goal of broad dissemination and incorporation into regular neuroscience practice.   
Additional information:

FAS Research Development BRAIN Initiative Archive

Contact Us:
Questions about this announcement or proposal submission may be directed to Jennifer Corby
([email protected], 617-495-1590) or Susan Gomes ([email protected] 617-496-9448).

 

For Research Development Support (Finding Funding, Proposal Development Resources), go to research.fas.harvard.edu/research-development-support