NIH Small Business Innovation Research Grant for Artificial Pancreas Development in Type 1 Diabetes (SBIR R43/R44)

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.

Mechanism of Support.This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications.

Funds Available and Anticipated Number of Awards. The estimated amount of funds available for support of 4-10 projects awarded as a result of this announcement is $2M for fiscal year 2009. Future year amounts will depend on annual appropriations..

Budget and Project Period. For this funding opportunity, budgets up to $500,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $1,000,000 total costs per year and up to 3 years may be requested for Phase II.

Eligible Institutions/Organizations: Only United States SBCs are eligible to submit 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, (i.e., 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.