Opportunity Information: Apply for RFA CA 12 001
Apply for RFA CA 12 001
- 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 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 Oct 28, 2011 and posted on Oct 28, 2011.
- Applicants must submit their applications by Mar 27, 2012. (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 IIB Bridge Awards funding opportunity (R44), posted by the National Institutes of Health under Funding Opportunity Number RFA-CA-12-001, is designed to help small businesses push promising, NIH-funded cancer technologies past the Phase II development stage and into real-world commercialization. It targets small business concerns that already completed an NIH SBIR Phase II award and now need additional support to reach the milestones that typically unlock broader market adoption, regulatory progress, clinical validation, manufacturing scale-up, or investor and strategic partner readiness. The core idea is to "bridge" the well-known gap between successful government-backed R&D and the capital-intensive, execution-heavy steps required to launch a product in the oncology marketplace.
The scope of projects must fit squarely within cancer-focused product development and must align with one of three specific areas. The first area is cancer therapeutics, which generally includes drug candidates, biologics, targeted therapies, or other treatment modalities aimed at preventing, controlling, or eliminating cancer. The second area covers cancer imaging technologies, interventional devices, and in vivo diagnostics, meaning tools used inside or on the patient to visualize cancer, guide procedures, or detect disease using imaging and other in-body approaches. The third area is in vitro and ex vivo cancer diagnostics and prognostics, which includes laboratory-based tests and platforms that analyze patient samples (such as blood, tissue, or other biospecimens) to detect cancer, characterize tumor biology, predict outcomes, or guide treatment decisions. Across all three areas, the emphasis is not early discovery, but the next stage of development that materially advances a technology toward a commercial product.
This opportunity is offered as a grant mechanism under the SBIR program, with no cost sharing or matching requirement listed. Eligibility is limited to small businesses, consistent with SBIR rules, and the FOA is structured specifically for projects that were previously supported by NIH SBIR Phase II awards, reflecting its role as a follow-on translational push rather than a first-entry funding path. The funding activity categories are listed under education and health, and the relevant CFDA program areas include 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research), reinforcing that the supported work must be directly tied to oncology detection/diagnosis and/or therapeutic development.
In terms of funding scale, the FOA indicates an estimated total funding amount of $10,000,000 and an award ceiling of $1,000,000. Practically, that ceiling signals support for discrete, milestone-driven development packages that can demonstrate readiness for commercialization, such as finalizing a prototype, completing key preclinical studies, performing clinical feasibility work, validating analytical or clinical performance of a diagnostic, advancing a device through engineering verification and validation, strengthening quality systems, or completing other pivotal steps that reduce risk for customers, regulators, and investors. While the summary does not list required milestones or deliverables, the "Bridge Award" framing strongly implies that applications are expected to present a credible commercialization trajectory and a development plan that directly addresses the remaining barriers to market entry.
Key administrative details show that the FOA was posted on October 28, 2011, with an original and current closing date of March 27, 2012, and an archive date of April 27, 2012, meaning it was a time-limited solicitation rather than an open-ended program announcement. The administering agency is NIH, and the public-facing announcement was hosted through the NIH grants guide. For access issues or technical problems with the posting, the contact listed is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV), indicating the contact is oriented to announcement access and linking support rather than scientific or grants management questions.
SBIR Phase IIB Bridge Awards (R44) - FAQ
What is the SBIR Phase IIB Bridge Awards funding opportunity (R44)?
The SBIR Phase IIB Bridge Awards (R44) is an NIH grant opportunity designed to help small businesses move promising, NIH-funded cancer technologies beyond SBIR Phase II and closer to real-world commercialization. The program is meant to "bridge" the gap between successful government-supported R&D and the capital-intensive steps needed to launch an oncology product.
What is the Funding Opportunity Number (FOA) for this opportunity?
The Funding Opportunity Number is RFA-CA-12-001.
Who is the administering agency?
The administering agency is the National Institutes of Health (NIH).
What is the main purpose of a Phase IIB "Bridge Award"?
The purpose is to provide additional support after SBIR Phase II so a small business can reach development milestones that typically enable commercialization progress, such as regulatory advancement, clinical validation, manufacturing scale-up, and increased readiness for investors or strategic partners.
Is this opportunity focused on early-stage discovery research?
No. The emphasis is on the next stage of development that materially advances a technology toward a commercial cancer product, not early discovery.
What types of projects are in scope?
Projects must be cancer-focused product development and must align with one of three areas: cancer therapeutics; cancer imaging technologies, interventional devices, and in vivo diagnostics; or in vitro and ex vivo cancer diagnostics and prognostics.
What does "cancer therapeutics" include under this opportunity?
Cancer therapeutics generally includes drug candidates, biologics, targeted therapies, and other treatment modalities aimed at preventing, controlling, or eliminating cancer.
What does the imaging and in vivo diagnostics area cover?
This area includes cancer imaging technologies, interventional devices, and in vivo diagnostics, meaning tools used inside or on the patient to visualize cancer, guide procedures, or detect disease using imaging and other in-body approaches.
What does "in vitro and ex vivo cancer diagnostics and prognostics" mean here?
It refers to laboratory-based tests and platforms that analyze patient samples (such as blood, tissue, or other biospecimens) to detect cancer, characterize tumor biology, predict outcomes, or help guide treatment decisions.
Who is eligible to apply?
Eligibility is limited to small business concerns, consistent with SBIR rules, and the opportunity is structured specifically for projects that were previously supported by an NIH SBIR Phase II award.
Do applicants need to have completed an NIH SBIR Phase II award?
Yes. The opportunity targets small businesses that already completed an NIH SBIR Phase II award and need additional support to move the technology toward commercialization.
Is cost sharing or matching required?
No cost sharing or matching requirement is listed for this opportunity.
What are the funding activity categories for this FOA?
The funding activity categories are listed under education and health.
Which CFDA program areas are associated with this opportunity?
The relevant CFDA program areas include 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
What is the estimated total funding amount?
The FOA indicates an estimated total funding amount of $10,000,000.
What is the maximum award amount (award ceiling)?
The award ceiling is $1,000,000.
What kinds of activities might the award support as part of commercialization readiness?
Based on the opportunity description, the funding is intended to support milestone-driven development steps that reduce commercialization risk, such as finalizing a prototype, completing key preclinical studies, performing clinical feasibility work, validating analytical or clinical performance for a diagnostic, advancing a device through engineering verification and validation, strengthening quality systems, or completing other pivotal steps that improve readiness for customers, regulators, and investors.
Are specific milestones or deliverables listed in the summary provided?
No. The summary does not list required milestones or deliverables, but the "Bridge Award" framing implies applicants are expected to present a credible commercialization trajectory and a development plan addressing barriers to market entry.
When was this funding opportunity posted?
The FOA was posted on October 28, 2011.
What was the closing date for applications?
The original and current closing date was March 27, 2012.
Is this an ongoing program or a time-limited solicitation?
It was a time-limited solicitation rather than an open-ended program announcement, based on the listed posting, closing, and archive dates.
When was the opportunity archived?
The archive date was April 27, 2012.
Where was the public announcement hosted?
The public-facing announcement was hosted through the NIH grants guide.
Who is the listed contact, and what is that contact best suited for?
The contact listed is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV). Based on the description, this contact is oriented to access issues or technical problems with the posting, rather than scientific or grants management questions.
Does the opportunity explicitly mention support for investor or strategic partner readiness?
Yes. The description highlights that the award is intended to help companies reach milestones that can unlock investor and strategic partner readiness, along with other commercialization-related progress.
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