SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics and Prognostics Toward Commercialization (R44)

National Cancer Institute

  • Purpose: This Funding Opportunity Announcement (FOA) 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 under SBIR or STTR Phase II awards from any Federal agency. 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 or STTR Phase II projects to the commercialization stage. This FOA is expected to promote partnerships between Federally-funded SBIR or STTR 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.
  • Eligibility:
    • Eligible Organizations: 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 must be less than 50 percent participation by foreign business entities in the joint venture;
      3. i. SBIR and STTR.  Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR ii. SBIR-only.  Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.  No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR iii. SBIR and STTR.  Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
      4. Has, including its affiliates, not more than 500 employees.
    • Eligible Individuals (Program Director/Principal Investigator): Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.
      • Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
    • Number of Applications: Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

      • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
      • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
      • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

    • General Requirements: The Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previous Federally-funded SBIR or STTR Phase II award. Phase IIB Bridge Award applications may be predicated on the following categories of prior Phase II awards:
      • SBIR Phase II grant or contract awards funded by any Federal agency
      • STTR Phase II grant or contract awards funded by any Federal agency

NOTE: Applicants who intend to submit a Phase IIB Bridge Award application that is predicated on a Phase II award funded by a Federal agency other than the NIH or a previous Phase II contract award MUST contact the SBIR Development Center prior to submission, so that the NCI can properly arrange for such applications to be accepted.

The qualifying “parent” SBIR or STTR Phase II project may be renewed only once through the Phase IIB Bridge Award under this FOA. Following the Phase II Bridge Award period (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.

This FOA is only open to SBIR or STTR Phase II projects nearing completion and those that have recently ended. To be eligible under the current FOA, current Phase II projects MUST end on or before August 31, 2015. In general, past Phase II projects should have ended within 24 months of the application receipt date. The NCI will consider longer periods of hiatus on a case-by-case basis provided that the applicants can demonstrate the readiness of the proposed project for commercialization and the ability to secure substantial third-party investor funds. In all cases, the Phase II project period must end before a Phase IIB Bridge Award can be issued.

    • Contractual/Consortium Arrangements: In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above.  A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF424 (R&R) application forms.

  • Letter of Intent: April 13, 2015
  • Application Receipt Date(s): May 13, 2015
  • Award Amount: Budgets up to $1,000,000 Total Costs per year may be requested.
  • Project Period: Three years

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