Advanced Neural Prosthetics Research and Development (U01)

archived

Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and pilot clinical studies for neural prosthetics. The program will utilize the cooperative agreement mechanism to enable support for milestone-driven projects for the design, development, and demonstration of clinically-useful neural prosthetic devices.Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for clinical study, and proof-of-concept or pilot clinical studies. Mechanism of Support. This FOA will utilize the U01 Research Project Cooperative Agreement grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-09-064, that encourages fast-track or phase II applications for cooperative agreements under the Small Business Innovation Research (SBIR) cooperative agreement mechanism (U44).Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.Budget and Project Period. Budgets for direct costs per year will depend upon specific project requirements, and project duration of up to five years may be requested. The maximum direct costs for any single year may not exceed $1,000,000 per yearApplication Research Plan Component Length. Applications submitted in response to this FOA for Advanced Neural Prosthetics Research and Development projects (U01) are limited to 25 pages for sections 2-5 of PHS 398.Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct. Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016.Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.Renewals. Applicants may submit a renewal (formally competing continuation) application if the proposed research is a logical progression of the currently funded NIH U01 project.

High