Opportunity Information: Apply for RFA CA 22 025
The SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional), funding opportunity number RFA-CA-22-025, is a National Institutes of Health program (through the National Cancer Institute) designed to help small businesses push promising cancer-related technologies past the SBIR/STTR Phase II stage and into real-world commercialization. It specifically targets projects that already received a Phase II SBIR or STTR award from any federal agency and now need additional resources to complete the next, often more expensive, development steps that stand between an advanced prototype or validated approach and a market-ready product or service. In practice, this FOA is meant to bridge the so-called "valley of death" where technologies can stall due to the high cost of late-stage development, scaling, regulatory work, clinical evaluation, manufacturing readiness, or market preparation.
A central theme of this opportunity is leveraging outside capital and partnerships. The program is structured to encourage (and effectively require) meaningful engagement from independent third-party investors and/or strategic partners, such as venture investors, corporate partners, foundations, or other non-federal sources that can help carry the technology forward. Applicants must submit a Commercialization Plan that lays out a credible path to market and clearly explains the status of third-party support. This includes detailing investor or partner funding that has already been secured or that is realistically expected during the Phase IIB project period. The FOA sets a strong expectation that the amount of independent third-party funding will be equal to or greater than the amount of NCI funding requested over the entire Phase IIB Bridge Award period, reinforcing the idea that NCI funds are intended to catalyze and de-risk a product on a trajectory that the private or non-federal sector is also willing to back.
The scope of work can span both preclinical and clinical development, depending on what is appropriate for the technology and its maturity. That means projects may focus on advanced preclinical milestones (for example, optimization, validation in relevant models, manufacturing process development, analytical validation, quality systems, or regulatory preparation) and/or clinical-stage work. Clinical trials are explicitly allowed under this announcement but are not mandatory, making the program flexible for technologies that are not yet ready for a trial or that require additional preclinical evidence, design finalization, or regulatory groundwork before entering human studies. The mechanism is R44 (SBIR), and it is labeled "Clinical Trial Optional," signaling that proposed clinical evaluation is acceptable when justified but not a requirement for competitiveness on its own.
Eligibility is limited to small business concerns, consistent with SBIR rules. Foreign institutions (non-U.S. entities) cannot apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components may be permitted in certain circumstances as defined under the NIH Grants Policy Statement, meaning a U.S.-based small business could potentially include some foreign work as a component if it meets NIH policy requirements and is justified, but the applicant organization itself must be eligible and U.S.-based.
From the funding details provided, the opportunity falls under discretionary grant funding, with activity categories listed under education and health and CFDA numbers 93.394 and 93.395. The award ceiling is listed as $2,000,000, indicating the maximum amount that can be requested under the FOA (subject to the full FOA terms, budget structure, and project period expectations). The original closing date shown is 2022-08-05, and the creation date is 2022-04-05. Overall, the program is best understood as a commercialization-focused extension for strong Phase II projects: it is not meant for early feasibility concepts, but for technologies that have already demonstrated enough progress to attract non-federal backing and that need a final, well-planned push to reach commercialization-ready milestones in the cancer space.Apply for RFA CA 22 025
- 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 2022-04-05.
- Applicants must submit their applications by 2022-08-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- 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), funding opportunity number RFA-CA-22-025. It is a National Institutes of Health program administered through the National Cancer Institute (NCI) to help small businesses move cancer-relevant technologies beyond SBIR/STTR Phase II and closer to commercialization.
What is the main purpose of the Phase IIB Bridge Award?
The main purpose is to help technologies cross the late-stage development gap often called the "valley of death," where promising projects can stall due to the cost and complexity of advanced development. The program is intended to fund the next steps needed to turn an advanced prototype or validated approach into a product or service that is ready for real-world commercialization.
Who is eligible to apply?
Eligibility is limited to small business concerns under SBIR rules. In addition, the project must be based on a technology that already received a Phase II SBIR or STTR award from any federal agency.
Does my project need to have had a prior SBIR or STTR award?
Yes. This program specifically targets projects that already received a Phase II SBIR or STTR award (from any federal agency) and now need additional support to complete later-stage development steps.
Is this opportunity only for cancer-related technologies?
Yes. The focus is on cancer-relevant technologies, consistent with NCI's mission and the intent of the program to advance technologies toward commercialization in the cancer space.
What types of development activities can be supported?
The scope can include advanced preclinical and/or clinical development, depending on the maturity of the technology. Examples of supported late-stage steps include optimization, validation in relevant models, manufacturing process development, analytical validation, quality systems, regulatory preparation, clinical evaluation, scaling, manufacturing readiness, and market preparation.
Are clinical trials required?
No. Clinical trials are allowed but not required. The announcement is labeled "Clinical Trial Optional," meaning clinical evaluation can be proposed when justified, but a clinical trial is not mandatory for the project to be responsive to the opportunity.
What grant mechanism is used for this program?
The mechanism is R44 (SBIR). The opportunity is explicitly described as "Clinical Trial Optional."
What is the emphasis on third-party investors or strategic partners?
A central theme is leveraging outside capital and partnerships. The program is structured to encourage, and effectively require, meaningful engagement from independent third-party investors and/or strategic partners (for example, venture investors, corporate partners, foundations, or other non-federal sources) that can help move the technology toward commercialization.
Is third-party funding required, and how much is expected?
The FOA sets a strong expectation that independent third-party funding will be equal to or greater than the amount of NCI funding requested over the entire Phase IIB Bridge Award period. This reflects the intent that NCI funding helps catalyze and de-risk a technology that has a credible path to market and non-federal backing.
What is a Commercialization Plan, and why is it important here?
Applicants must submit a Commercialization Plan that describes a credible path to market and explains the status of third-party support. This includes describing investor or partner funding that has already been secured or that is realistically expected during the Phase IIB project period.
What does it mean that the program bridges the "valley of death"?
It means the program is designed for technologies that are beyond early feasibility and have already shown enough progress to justify continued investment, but still face expensive and complex steps before they can become market-ready. These steps can include regulatory work, clinical evaluation, scaling, manufacturing readiness, and other late-stage development needs.
Can a non-U.S. company apply?
No. Foreign institutions (non-U.S. entities) cannot apply, and non-domestic components of U.S. organizations are also not eligible to apply under this opportunity.
Can a U.S. small business include any foreign work on the project?
Potentially. While the applicant organization must be an eligible U.S.-based small business, foreign components may be permitted in certain circumstances as defined under the NIH Grants Policy Statement, if the inclusion is justified and meets NIH policy requirements.
What is the maximum funding amount listed for this opportunity?
The award ceiling is listed as $2,000,000, which indicates the maximum amount that can be requested under this FOA (subject to the FOA's full terms, budget structure, and project period expectations).
What agency is offering this program?
This is an NIH program administered through the National Cancer Institute (NCI).
What kind of funding is this classified as?
It is listed as discretionary grant funding, with activity categories under education and health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.394 and 93.395.
What are the key dates provided?
The creation date shown is 2022-04-05, and the original closing date shown is 2022-08-05.
Is this program meant for early-stage concepts or feasibility work?
No. It is described as a commercialization-focused extension for strong Phase II projects. It is intended for technologies that have already advanced beyond Phase II outcomes and need a final, well-planned push to reach commercialization-ready milestones.
What makes a project a good fit for this opportunity based on the description?
A good fit is a cancer-relevant technology that has already completed a Phase II SBIR or STTR award, has progressed to an advanced prototype or validated approach, can define clear late-stage development milestones, and can demonstrate meaningful independent third-party interest and/or financial support consistent with the program's expectations.
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