Advanced Neural Prosthetics Research and Development (SBIR [U44])

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Purpose. This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose 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 Small Business Innovation Research (SBIR) cooperative agreement mechanism (U44) for Phase II and Fast-Track applications and runs in parallel with a FOA of identical scientific scope, PA-09-063, which encourages applications under the U01 Research Project Cooperative Agreement grant mechanism. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. Budget and Project Period. Phase II applicants may request a budget of up to $1 million total costs per year and a project period of up to three years.Fast-Track applicants may request a budget for the Phase I portion of the Fast-Track of up to $300,000 total costs per year and a project period of up to two years.Phase II competing renewal budgets up to $1 million total costs per year and time periods up to three years may be requested. Eligible Institutions/Organizations: Only United States SBCs are eligible to receive SBIR applications. A SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets ALL of the criteria as described in Section III. Eligible Project Directors/Principal Investigators: Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their 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. On an SBIR application, the PD/PI must have his/her primary employment (more than 50%) with the SBC at the time of award and for the duration of the project. Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application. Number of Applications: Applicant SBCs may submit more than one application, provided 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:Only Phase II SBIR awardees are eligible to submit a competing renewal application, which should represent a continuation of support for research and development of the previous work funded by the original Phase II grant.

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