Opportunity Information: Apply for RFA CA 10 009
Apply for RFA CA 10 009
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "SBIR Phase II Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics toward Commercialization (R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Jan 5, 2010 and posted on Jan 5, 2010.
- Applicants must submit their applications by Mar 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The SBIR Phase II Bridge Awards FOA (RFA-CA-10-009) is a National Institutes of Health funding opportunity designed to help small businesses push cancer-related technologies past the typical “end of Phase II” bottleneck and into the commercialization stage. It specifically targets projects that have already been funded under an NIH SBIR Phase II award and now need additional resources to complete the next, often capital-intensive steps that make a product viable for market entry. In other words, this is meant to be a bridge between successful Phase II research and the real-world development work that positions a technology for adoption, regulatory progress, manufacturing scale-up, clinical validation, or market launch.
The scope is focused on three broad categories of cancer innovation. First, it supports cancer therapeutics, which can include drug candidates, biologics, and other treatment modalities that still require preclinical development, IND-enabling work, early clinical testing, or related translational milestones. Second, it includes cancer imaging technologies, interventional devices, and in vivo diagnostics, meaning tools used directly in or on patients such as imaging platforms, device-based approaches, image-guided interventions, and diagnostics performed in the body. Third, it supports in vitro and ex vivo diagnostics and prognostics, covering lab-based tests and assays run on patient samples outside the body, including technologies aimed at detection, diagnosis, disease stratification, or predicting outcomes and treatment response.
A central feature of this Bridge Award is the strong emphasis on third-party investment or strategic partnership. NIH is signaling that commercialization readiness is not only about technical progress, but also about validating market interest and securing non-governmental capital. Applicants are required to submit a commercialization plan that clearly describes investor or partner funding that has already been secured or is expected during the Bridge Award period. The program expectation is that this independent third-party support will match or exceed the amount requested from NCI over the course of the project, effectively creating a leverage model where federal funds are paired with private or strategic capital to accelerate development timelines.
From a project design standpoint, the FOA allows work at either the preclinical or clinical stage, depending on what is most appropriate for the technology’s path to commercialization. Clinical trials are permitted when justified, but they are not mandatory, so companies can propose other commercialization-critical activities such as advanced prototyping, validation studies, regulatory planning and submissions, manufacturing process development, quality systems work, or preparations for partnering and market entry. The key is that the proposed work represents a logical “next stage” after a prior NIH SBIR Phase II project and that it directly advances the product toward commercialization rather than basic discovery.
The funding mechanism is the NIH SBIR Phase II (R44) competing renewal mechanism, referred to in this announcement as the SBIR Phase II Bridge Award. Eligibility is limited to small business concerns. There is no cost sharing or matching requirement in the formal sense, but the program’s structure effectively requires substantial third-party financial commitment through the commercialization plan and the expectation of outside funds at least equal to the NCI request.
For this specific posting cycle, the NIH estimated total funding available was $10,000,000 for fiscal year 2010, with an anticipated number of up to ten awards. The listed award ceiling is $1,000,000. As with many federal programs, funding levels in future years were noted as dependent on annual appropriations. Administrative details in the source listing show the opportunity was posted January 5, 2010, with an original and current closing date of March 1, 2010, and an archive date of April 1, 2010. The relevant CFDA program areas include cancer detection and diagnosis research (93.394) and cancer treatment research (93.395).
Overall, this FOA is best understood as a commercialization accelerator for NIH-backed SBIR Phase II cancer projects that have demonstrated promise and now need a final push, plus credible external financial or strategic backing, to cross into commercially actionable development and deployment.
SBIR Phase II Bridge Awards (RFA-CA-10-009) FAQs
What is the SBIR Phase II Bridge Awards FOA (RFA-CA-10-009)?
The SBIR Phase II Bridge Awards FOA (RFA-CA-10-009) is a National Institutes of Health (NIH) funding opportunity designed to help small businesses advance cancer-related technologies beyond the typical end-of-Phase-II bottleneck and into commercialization-focused development.
What problem is this Bridge Award intended to solve?
This program is intended to address the common gap that occurs after an NIH SBIR Phase II project ends, when a technology may be scientifically promising but still needs additional, often capital-intensive work to become commercially viable (for example, regulatory progress, manufacturing scale-up, clinical validation, or market launch preparation).
Who is this funding opportunity for?
Eligibility is limited to small business concerns. It specifically targets projects that have already been funded under an NIH SBIR Phase II award and now require additional resources to reach commercialization milestones.
Does my project need to have had an NIH SBIR Phase II award already?
Yes. The opportunity is designed for projects that have already received NIH SBIR Phase II funding and need a logical next-stage bridge to commercialization.
What types of cancer technologies are within scope?
The FOA focuses on three broad categories: (1) cancer therapeutics, (2) cancer imaging technologies, interventional devices, and in vivo diagnostics, and (3) in vitro and ex vivo diagnostics and prognostics.
What kinds of cancer therapeutics does the FOA support?
Cancer therapeutics can include drug candidates, biologics, and other treatment modalities that require steps such as preclinical development, IND-enabling work, early clinical testing, or related translational milestones.
What are “cancer imaging technologies, interventional devices, and in vivo diagnostics” in this FOA?
These refer to tools used directly in or on patients, such as imaging platforms, device-based approaches, image-guided interventions, and diagnostics performed in the body (in vivo).
What are “in vitro and ex vivo diagnostics and prognostics” in this FOA?
These include lab-based tests and assays run on patient samples outside the body. They can support detection, diagnosis, disease stratification, and technologies that predict outcomes or treatment response.
Is the Bridge Award focused on research or commercialization?
It is positioned as a commercialization accelerator. The work proposed should represent a logical next stage after the prior Phase II project and should directly advance the product toward commercialization rather than basic discovery.
What stages of development can be proposed (preclinical vs. clinical)?
The FOA allows work at either the preclinical or clinical stage, depending on what is most appropriate for the technology’s path to commercialization.
Are clinical trials required under this FOA?
No. Clinical trials are permitted when justified, but they are not mandatory.
What types of activities can be supported if a clinical trial is not proposed?
The FOA notes commercialization-critical activities such as advanced prototyping, validation studies, regulatory planning and submissions, manufacturing process development, quality systems work, and preparations for partnering and market entry.
What is the role of third-party investment or strategic partnership in this program?
A central feature of the Bridge Award is its strong emphasis on third-party investment or strategic partnership. NIH is signaling that commercialization readiness includes both technical progress and validation of market interest through non-governmental capital or strategic support.
Is third-party funding required?
Applicants are required to submit a commercialization plan describing investor or partner funding that has already been secured or is expected during the Bridge Award period. The program expectation is that independent third-party support will match or exceed the amount requested from NCI over the course of the project.
Does the FOA require formal cost sharing or matching funds?
No formal cost sharing or matching requirement is stated. However, the program structure effectively requires substantial third-party financial commitment through the commercialization plan and the expectation of outside funds at least equal to the NCI request.
What must the commercialization plan include regarding investors or partners?
It must clearly describe investor or partner funding that has already been secured or is expected during the Bridge Award period, aligning with the program’s leverage model where federal funds are paired with third-party support.
What is the funding mechanism for this opportunity?
The funding mechanism is the NIH SBIR Phase II (R44) competing renewal mechanism, referred to in this announcement as the SBIR Phase II Bridge Award.
How much funding was available for this posting cycle?
For fiscal year 2010, NIH estimated total funding available at $10,000,000, with an anticipated number of up to ten awards.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $1,000,000.
How many awards were anticipated?
The FOA anticipated up to ten awards for the referenced fiscal year cycle.
Is funding guaranteed in future years?
No. The FOA notes that future-year funding levels are dependent on annual appropriations.
When was this opportunity posted and when did it close?
The source listing shows it was posted on January 5, 2010, with an original and current closing date of March 1, 2010, and an archive date of April 1, 2010.
What are the relevant CFDA program areas listed for this opportunity?
The relevant CFDA program areas include cancer detection and diagnosis research (93.394) and cancer treatment research (93.395).
What is the overall purpose of RFA-CA-10-009 in plain terms?
It is meant to help NIH-backed SBIR Phase II cancer projects that have demonstrated promise get a final push into commercially actionable development and deployment, with credible external financial or strategic backing to accelerate timelines.
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