National 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. |