Opportunity Information: Apply for RFA CA 16 008
Apply for RFA CA 16 008
- The HHS-NIH11 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, 93.395,.
- This funding opportunity was created on Feb 18, 2016 and posted on Feb 18, 2016.
- Applicants must submit their applications by Jul 13, 2016. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The SBIR Phase II Bridge Awards FOA (R44), listed as RFA-CA-16-008, is a National Cancer Institute (NCI) funding opportunity designed to help small businesses push promising cancer-related innovations past the SBIR/STTR Phase II stage and closer to real-world commercialization. It targets projects that have already received a Phase II award from any federal agency and now need additional support to complete the next set of expensive, high-effort milestones that typically stand between a validated prototype or proof-of-concept and a product that can realistically enter the market, attract customers, and achieve regulatory and reimbursement readiness where applicable.
The program focuses on three broad technology areas tied directly to cancer care and cancer research translation. The first area is cancer therapeutics, which can include drug candidates, biologics, drug delivery technologies, or other treatment approaches intended to prevent, treat, or manage cancer. The second area covers cancer imaging technologies, interventional devices, and in vivo diagnostics, meaning tools used inside the body or in real-time clinical settings, such as imaging platforms, image-guided devices, minimally invasive instruments, or diagnostic approaches used during procedures or patient evaluation. The third area includes in vitro and ex vivo cancer diagnostics and prognostics, which generally refers to tests performed on patient samples outside the body, such as assays run on blood, tissue, or other biospecimens, including tools aimed at detecting cancer, classifying disease, predicting outcomes, or guiding treatment decisions.
A central theme of this FOA is bridging the funding and execution gap between prior federal innovation support and commercial investment. NCI is explicitly trying to encourage partnerships between Phase II awardees and outside capital sources, such as independent third-party investors and/or strategic partners (for example, venture capital, angel groups, corporate partners, or other non-federal funding sources). The expectation is that applicants will not rely solely on government dollars to move forward. Instead, the Bridge Award is meant to complement significant outside commitment, reflecting that commercialization typically requires larger budgets than a standard research grant can provide.
To reinforce that commercialization focus, applicants are required to submit a Commercialization Plan. This plan is not just a formality; it is intended to show a credible path to market and should spell out the business case, competitive positioning, milestones, risks, and practical steps needed to turn the project into a sellable product or service. A key requirement is that the plan include specifics about third-party investor funding that has already been secured or is expected during the Bridge Award project period. Importantly, the FOA states that the level of this independent third-party funding is expected to be equal to or greater than the amount of NCI funding requested over the Phase IIB Bridge project period, effectively making meaningful outside capital a core part of the project’s execution strategy.
In terms of development stage, the FOA allows projects spanning preclinical and clinical development. That means a company could propose work such as advanced preclinical validation, manufacturing scale-up planning, design controls, verification and validation, regulatory engagement, or early clinical feasibility activities, depending on what is most appropriate for the technology and its risk profile. Clinical trials are allowed if they make sense for the project, but they are not mandatory, which gives applicants flexibility to propose the most logical next steps for de-risking and commercialization rather than forcing a trial before the project is ready.
Administratively, this is a discretionary grant opportunity under HHS/NIH (Agency listed as HHS-NIH11), limited to eligible small businesses. The CFDA numbers associated with the opportunity are 93.394 and 93.395. The posting and creation dates were February 18, 2016, with an original and current closing date of July 13, 2016. The FOA listed an award ceiling of $1,000,000 and anticipated making about 10 awards, indicating it was competitive and aimed at a relatively small set of projects that could demonstrate strong readiness for the commercialization push and credible third-party support.
Overall, this FOA is best understood as a commercialization accelerator for SBIR/STTR Phase II alumni in the cancer space: it provides up to a defined funding level to help complete the next major translation steps, but it is structured to work alongside substantial outside investment or strategic partnering, with the explicit goal of getting new cancer therapeutics, diagnostics, prognostics, imaging tools, and interventional technologies to the point where they can be launched, adopted, and sustained in the marketplace.
Frequently Asked Questions (FAQs)
What is the SBIR Phase II Bridge Awards FOA (R44), RFA-CA-16-008?
RFA-CA-16-008 is a National Cancer Institute (NCI) SBIR funding opportunity (R44) designed to help small businesses move promising cancer-related innovations beyond the SBIR/STTR Phase II stage and closer to commercialization. It is specifically intended to support the next set of costly, high-effort milestones that often sit between a validated prototype/proof-of-concept and a product that can realistically enter the market.
What problem is this Bridge Award meant to solve?
The program is meant to bridge a common gap: Phase II-level federal innovation support may validate technical feasibility, but commercialization typically requires more time, money, and execution than Phase II alone can cover. This FOA supports the work needed to get a technology closer to launch and to investment, customer adoption, and (when relevant) regulatory and reimbursement readiness.
Who is the funding agency and what type of opportunity is it?
The funding agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), specifically the National Cancer Institute (NCI). It is described as a discretionary grant opportunity, and it is limited to eligible small businesses.
What projects are eligible in terms of prior SBIR/STTR status?
The FOA targets projects that have already received an SBIR or STTR Phase II award from any federal agency and now need additional support to complete the next major development and commercialization milestones.
What cancer-related technology areas does the FOA focus on?
The FOA focuses on three broad areas tied to cancer care and translation of cancer research:
- Cancer therapeutics (for example, drug candidates, biologics, drug delivery technologies, or other treatment approaches to prevent, treat, or manage cancer)
- Cancer imaging technologies, interventional devices, and in vivo diagnostics (tools used inside the body or in real-time clinical settings, such as imaging platforms, image-guided devices, minimally invasive instruments, or diagnostics used during procedures or patient evaluation)
- In vitro and ex vivo cancer diagnostics and prognostics (tests performed on patient samples outside the body, such as assays run on blood, tissue, or other biospecimens, including tools for detection, classification, outcome prediction, or treatment guidance)
Is the program focused more on research or commercialization?
The central theme is commercialization. The Bridge Award is positioned as a commercialization accelerator intended to help Phase II awardees reach the level of readiness needed for real-world market entry and sustainability.
Are applicants expected to have outside investors or strategic partners?
Yes. NCI explicitly encourages partnerships between Phase II awardees and outside capital sources and/or strategic partners, such as venture capital, angel groups, corporate partners, or other non-federal funding sources. The FOA emphasizes that applicants should not rely only on government funds to move the project forward.
How important is third-party investor funding in this FOA?
Third-party funding is a core requirement. The Commercialization Plan must include specifics about independent third-party investor funding that has already been secured or is expected during the Bridge Award project period.
Is there a minimum expectation for the amount of outside capital?
Yes. The FOA states that the level of independent third-party funding is expected to be equal to or greater than the amount of NCI funding requested over the Phase IIB Bridge project period.
What is the Commercialization Plan and why does it matter?
Applicants are required to submit a Commercialization Plan. It is intended to demonstrate a credible path to market and should address the business case, competitive positioning, milestones, risks, and practical steps needed to turn the project into a sellable product or service. It is not treated as a formality; it is central to showing the project is commercially viable and properly financed.
What stages of development can be supported (preclinical vs. clinical)?
The FOA allows projects spanning both preclinical and clinical development. This includes advanced preclinical validation as well as clinically oriented activities when appropriate.
Are clinical trials required under this FOA?
No. Clinical trials are allowed if they make sense for the project, but they are not mandatory. The FOA is structured to let companies propose the most logical next steps for de-risking and commercialization rather than forcing a clinical trial prematurely.
What kinds of activities might a company propose with Bridge Award support?
Based on the description, examples include advanced preclinical validation, manufacturing scale-up planning, design controls, verification and validation, regulatory engagement, and early clinical feasibility activities, depending on what best supports the technology and its risk profile.
How much funding is available per award?
The FOA lists an award ceiling of $1,000,000.
How competitive is this opportunity?
The FOA anticipated making about 10 awards, suggesting a competitive program aimed at a relatively small number of projects that can show strong commercialization readiness and credible third-party support.
What are the CFDA numbers associated with this opportunity?
The CFDA numbers listed are 93.394 and 93.395.
What are the key dates for this FOA?
The posting/creation date was February 18, 2016. The original and current closing date listed was July 13, 2016.
Which agency identifier is associated with the posting?
The opportunity lists the agency as HHS-NIH11.
What is the overall goal of the SBIR Phase II Bridge Award in the cancer space?
The goal is to help SBIR/STTR Phase II alumni in cancer-related fields complete the next major translation steps so their therapeutics, diagnostics, prognostics, imaging tools, or interventional technologies can be launched, adopted, and sustained in the marketplace, supported by substantial non-federal investment or strategic partnerships.
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