Opportunity Information: Apply for RFA CA 20 033
The SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44, Clinical Trial Optional) is a National Institutes of Health funding opportunity from the National Cancer Institute (NCI) designed to help small businesses push promising, cancer-relevant technologies out of the Phase II research stage and into real-world commercialization. It specifically targets projects that have already been supported through an SBIR or STTR Phase II award (from any federal agency, not just NIH) and now need additional resources to complete the next, often more expensive steps required to reach the market. In practical terms, this FOA is about closing the gap between a proven Phase II outcome (like a validated prototype or strong early performance data) and the kind of product readiness investors, partners, regulators, and customers expect.
A central feature of this program is the "bridge" concept: NCI funding is meant to be matched or exceeded by outside, independent third-party support. The FOA strongly emphasizes partnerships with third-party investors and/or strategic partners (for example, venture capital, angel investors, corporate partners, foundations, or other non-federal sources) to share risk and accelerate development. Applicants are required to submit a detailed Commercialization Plan that lays out the path to market and clearly describes third-party funding that has already been secured or that is expected during the Phase IIB project period. The expectation is that the amount of independent third-party funding will be equal to or greater than the total NCI funds requested over the life of the Phase IIB Bridge Award, signaling that the project has credible market pull and external validation.
The scope of work supported under this FOA can cover both preclinical and clinical stages of development, depending on what is needed to reach commercialization for the specific technology. That can include late-stage product development activities, refinement and scale-up, validation studies, regulatory preparation, and other milestones that typically sit between academic-style R&D and a commercial launch. Clinical trials are allowed but not required, meaning a company can propose clinical trial activities if they are appropriate for the technology and commercialization pathway, but the program is not limited only to clinical trial proposals. This makes the opportunity relevant across a wide range of cancer technologies, including but not limited to therapeutics, diagnostics, devices, imaging tools, software-enabled solutions, and platform technologies, as long as they are cancer-relevant and ready for the next major commercialization step.
Eligibility is limited to small business concerns applying under the SBIR mechanism, consistent with the program's purpose of advancing small-business-led innovation. Non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that certain "foreign components" may be allowable under NIH policy definitions and rules, so applicants with international collaborations or subcontracting needs would have to check the specific NIH Grants Policy Statement guidance and the FOA's eligibility details to determine what is permitted.
Administratively, this is a discretionary grant opportunity in the health area (CFDA numbers 93.394 and 93.395) with the funding opportunity number RFA-CA-20-033 and an original closing date of 2020-08-31. Overall, the program is structured to reward companies that have already demonstrated Phase II progress and can show a credible, investor-aligned plan to cross the expensive and operationally demanding stretch between technical feasibility and commercial readiness, with NCI funding acting as leverage alongside substantial third-party investment.Apply for RFA CA 20 033
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
- This funding opportunity was created on 2020-03-06.
- Applicants must submit their applications by 2020-08-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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FAQs: SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44, Clinical Trial Optional)
What is this funding opportunity?
This opportunity is the SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44, Clinical Trial Optional), a National Institutes of Health (NIH) funding opportunity from the National Cancer Institute (NCI). It is intended to help small businesses move promising, cancer-relevant technologies beyond the SBIR/STTR Phase II stage and closer to real-world commercialization.
What is the main purpose of the Phase IIB Bridge Award?
The core goal is to close the gap between Phase II outcomes (such as a validated prototype or strong early performance data) and the level of product readiness typically expected by investors, strategic partners, regulators, and customers. The award supports the next steps that are often larger, more costly, and more commercialization-focused than earlier R&D.
Who is this program designed for?
It is designed for small business concerns applying under the SBIR mechanism (R44). The program is structured for small businesses that have already demonstrated Phase II progress and now need additional resources to reach key commercialization milestones.
Do applicants need to have had prior SBIR or STTR funding?
Yes. The program specifically targets projects that have already been supported through an SBIR or STTR Phase II award. The Phase II award can be from any federal agency (not only NIH).
Is this award only for NIH-funded Phase II projects?
No. The Phase II prerequisite can come from any federal agency, not just NIH, as long as the project has already been supported through an SBIR or STTR Phase II award.
What does the term "bridge" mean in this FOA?
"Bridge" refers to NCI funding being used as leverage alongside outside, independent third-party support to accelerate development toward commercialization. The idea is to share risk and speed progress by combining federal funds with substantial external backing.
Is third-party funding required?
Yes. A central feature of the program is that NCI funding is meant to be matched or exceeded by outside, independent third-party support. The FOA emphasizes partnerships with investors and/or strategic partners and expects credible third-party funding during the Phase IIB project period.
How much third-party funding is expected compared to the NCI funds requested?
The FOA states an expectation that the amount of independent third-party funding will be equal to or greater than the total NCI funds requested over the life of the Phase IIB Bridge Award. This is intended to demonstrate market pull and external validation.
What kinds of third-party supporters are encouraged?
The FOA highlights independent third-party investors and/or strategic partners such as venture capital firms, angel investors, corporate partners, foundations, and other non-federal sources.
What must be included in the Commercialization Plan?
Applicants must submit a detailed Commercialization Plan that explains the path to market and clearly describes third-party funding that has already been secured or that is expected during the Phase IIB project period.
What types of activities can be supported with this funding?
The supported scope can include preclinical and clinical stages of development, depending on what is needed to reach commercialization for the specific technology. Examples described include late-stage product development activities, refinement and scale-up, validation studies, regulatory preparation, and other milestones that typically fall between academic-style R&D and a commercial launch.
Are clinical trials required?
No. Clinical trials are allowed but not required (clinical trial optional). A company can propose clinical trial activities if they fit the technology and commercialization pathway, but proposals do not have to include a clinical trial.
What types of technologies are considered relevant?
The opportunity is aimed at cancer-relevant technologies and is described as relevant across a wide range, including therapeutics, diagnostics, devices, imaging tools, software-enabled solutions, and platform technologies, as long as they are cancer-relevant and positioned for the next major step toward commercialization.
Is eligibility limited to small businesses?
Yes. Eligibility is limited to small business concerns applying under the SBIR mechanism, consistent with the program purpose of advancing small-business-led innovation.
Can non-U.S. (non-domestic) entities apply?
No. Non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply under this FOA.
Are non-U.S. components of U.S. organizations eligible?
No. The FOA states that non-U.S. components of U.S. organizations are also not eligible.
Are any international activities allowed at all?
The FOA notes that certain "foreign components" may be allowable under NIH policy definitions and rules. Applicants considering international collaborations or subcontracting should review the relevant NIH Grants Policy Statement guidance and the FOA's eligibility details to determine what is permitted.
Which NIH Institute/Center is associated with this opportunity?
This is a National Cancer Institute (NCI) opportunity under NIH.
What is the funding opportunity number?
The funding opportunity number provided is RFA-CA-20-033.
What mechanism is used for this award?
The mechanism referenced is R44, which is an SBIR award mechanism, and it is described as "Clinical Trial Optional."
What CFDA numbers are associated with this opportunity?
The information provided lists CFDA numbers 93.394 and 93.395.
What was the original closing date listed?
The original closing date provided is 2020-08-31.
What is the key review emphasis implied by the FOA description?
Based on the description, the FOA emphasizes demonstrated Phase II progress, a credible and detailed commercialization path, and strong independent third-party support that matches or exceeds the NCI funds requested, indicating external validation and readiness for the costly steps toward market.
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