Advanced Neural Prosthetics Research and Development (SBIR [U44])
Post Date
December 22nd 2008
Application Due Date
January 7th 2012
Funding Opportunity Number
PA-09-064
CFDA Number(s)
93.853
Funding Instrument Type(s)
Cooperative Agreement
Funding Activity Categories
Eligibility Categories
Other Eligible Applicants include the following: Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: Organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; In the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by business entities in the joint venture; At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States -- (except in the case of a joint venture); Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t). Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.
Funding
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Award Range:
$None - $None
Grant Description
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.
Contact Information
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Agency
Department of Health and Human Services
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Office:
National Institutes of Health
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