OpportunityTitle: SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics Toward Commercialization (R44)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following: Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:  1.  Is 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;  2.  Is 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 foreign business entities in the joint venture;  3.  Is 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 percent owned and controlled by another for-profit business concern that is at least 51 percent 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, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and   4.  Has, including its affiliates, not more than 500 employees.  SBCs must also meet 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. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R and R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.  Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Description: This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support the next stage of development for projects that were previously funded by NIH SBIR Phase II awards. Projects proposed in response to this FOA must be applicable to one of the following areas: (1) cancer therapeutics; (2) cancer imaging technologies, interventional devices, and in vivo diagnostics; or (3) in vitro and ex vivo cancer diagnostics and prognostics. The purpose of this FOA is to facilitate the transition of SBIR Phase II projects to the commercialization stage. This FOA is expected to promote partnerships between NIHs SBIR Phase II awardees and third-party investors and/or strategic partners to facilitate and accelerate the capital-intensive steps that are required to commercialize new products and services. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all Phase II SBIR applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the Phase IIB Bridge Award project period. It is expected that the level of this independent third-party funding will be equal to or greater than the NCI funds being requested throughout the Phase IIB Bridge Award project period. Proposed projects may address preclinical and/or clinical stages of technology development. Clinical trials may be proposed as appropriate but are not required.
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