Opportunity Information: Apply for RFA CA 12 023
Apply for RFA CA 12 023
- 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 Aug 17, 2012 and posted on Aug 17, 2012.
- Applicants must submit their applications by Mar 6, 2013. (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.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States,or it must be a for profit business concern that is at least 51 percent owned and controlled by another for profit business concern that is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees. SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other or (b) a third party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R and R) SBIR/STTR Application Guide should be referenced for detailed eligibility information. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
The SBIR Phase IIB Bridge Awards FOA (R44), issued by the National Cancer Institute (NCI) under NIH, was designed to help small businesses push cancer-related technologies that already completed an NIH SBIR Phase II project into the next, more expensive stage of development on the path to commercialization. The core idea is to provide a "bridge" between Phase II research and the activities needed to reach the market, especially when those activities require significant capital, added validation, and stronger commercial partnering than a typical Phase II award can support.
This opportunity focused on three broad technology areas: cancer therapeutics; cancer imaging technologies, interventional devices, and in vivo diagnostics; and in vitro or ex vivo cancer diagnostics and prognostics. In practical terms, that means projects could range from drug candidates and biologics to imaging agents or platforms, device-based interventions, and diagnostic tests that analyze patient samples. The FOA allowed work at either preclinical or clinical stages of development, and clinical trials could be included if they fit the product strategy, although a trial was not mandatory. The emphasis was on getting a project "commercial-ready" by tackling the key technical, regulatory, clinical, and manufacturing steps that commonly stand between a promising Phase II result and a viable commercial product.
A defining feature of the Phase IIB Bridge concept in this FOA was the expectation of meaningful third-party participation. NCI aimed for these awards to actively encourage partnerships between prior NIH SBIR Phase II awardees and outside investors or strategic partners (for example, venture investors, corporate partners, or other third-party funders). Applicants were required to submit a Commercialization Plan, consistent with NIH SBIR Phase II application expectations, but with specific attention to documenting third-party financing that had already been secured or was expected during the Bridge Award period. Importantly, the FOA stated that independent third-party funding was expected to be equal to or greater than the amount of NCI funding requested over the project period, signaling that NCI wanted its funds to leverage substantial external capital rather than serve as the sole support for late-stage development.
From a funding and administrative standpoint, the announcement was a discretionary grant opportunity with an estimated total funding level of about $10,000,000 and an expected 10 awards. The award ceiling was listed as $1,000,000. The program fell under CFDA numbers 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research). There was no cost sharing or matching requirement as a formal condition of the grant, though the third-party investment expectation effectively functioned as a commercialization leverage requirement in how competitive applications were framed.
Eligibility was limited to United States small business concerns (SBCs) meeting standard SBIR size and ownership rules at the time of the Phase I and Phase II awards. The business had to be for-profit, based in the United States, and primarily operating in the United States (or otherwise making a significant contribution to the U.S. economy). It had to be in an allowed legal form (such as an LLC or corporation), generally at least 51% U.S.-owned and controlled by U.S. citizens or permanent residents (with specific rules for joint ventures), and have no more than 500 employees including affiliates, consistent with SBA regulations in 13 C.F.R. Part 121. The FOA also noted that foreign components, as NIH defines them, could be allowed, which can matter for companies relying on specialized international capabilities, but the applicant entity itself needed to qualify as a U.S. SBC.
Timing and reference details in the source record indicate the FOA was posted on August 17, 2012 (RFA-CA-12-023), with an original and current closing date of March 6, 2013, and an archive date of April 6, 2013. In short, this was a time-limited NCI SBIR funding pathway meant for companies that already had validated Phase II progress and now needed a commercialization-focused infusion of NIH support, tightly coupled with outside investment or strategic partnering, to complete the major de-risking steps required for market entry in oncology therapeutics, devices, imaging, and diagnostics.
SBIR Phase IIB Bridge Awards (R44) - FAQ
What is the SBIR Phase IIB Bridge Awards FOA (R44)?
The SBIR Phase IIB Bridge Awards FOA (R44) was a National Cancer Institute (NCI) funding opportunity under NIH designed to help small businesses move cancer-related technologies that had already completed an NIH SBIR Phase II project into the next stage of development needed for commercialization. The purpose was to create a practical "bridge" between Phase II research results and the more expensive, commercialization-focused work required to reach the market.
What problem was this funding opportunity designed to address?
The FOA targeted the common gap between promising Phase II outcomes and commercial readiness. That gap often includes larger-scale validation, regulatory preparation, clinical and manufacturing steps, and partnering needs that typically require significantly more capital and external participation than a standard Phase II award supports.
Which agency issued this FOA?
The FOA was issued by the National Cancer Institute (NCI) under the National Institutes of Health (NIH).
What was the main goal of the Phase IIB Bridge concept in this FOA?
The main goal was to accelerate a Phase II-completed cancer technology toward the market by funding late-stage development activities while leveraging meaningful third-party participation (such as investors or strategic partners). NCI funding was intended to complement, not replace, substantial outside financing.
What technology areas were in scope?
The FOA focused on three broad technology areas:
- Cancer therapeutics
- Cancer imaging technologies, interventional devices, and in vivo diagnostics
- In vitro or ex vivo cancer diagnostics and prognostics
What types of projects could fit under cancer therapeutics?
Projects could include cancer drug candidates and biologics, as long as they were cancer-related technologies positioned to move from completed Phase II work into later-stage development needed for commercialization.
What kinds of imaging and device technologies were included?
The FOA explicitly included cancer imaging technologies, interventional devices, and in vivo diagnostics. In practical terms, this could include imaging agents or platforms and device-based interventions intended for use in oncology care.
What qualifies as in vitro or ex vivo diagnostics and prognostics under this FOA?
In vitro or ex vivo diagnostics and prognostics referred to diagnostic tests that analyze patient samples outside the body (for example, laboratory-based assays) and tools intended to provide diagnostic or prognostic information relevant to cancer.
Did projects need to be preclinical or clinical?
The FOA allowed work at either the preclinical or clinical stage of development. The emphasis was on completing the key steps needed to make the project commercial-ready.
Were clinical trials required?
No. Clinical trials could be included if they fit the product strategy, but a clinical trial was not mandatory under this FOA.
What kinds of activities was the award intended to support?
The award was intended to support the technical, regulatory, clinical, and manufacturing work that commonly stands between a successful Phase II project and a viable commercial product. The focus was on de-risking the technology and preparing it for market entry.
What made this a "Bridge" award rather than another Phase II award?
A defining feature was the expectation of meaningful third-party participation. The FOA was structured so that NCI funding would help bridge the gap to commercialization while external investors or strategic partners participated financially, reflecting the larger capital needs of late-stage development.
What was expected regarding third-party participation?
NCI expected independent third-party funding to be equal to or greater than the amount of NCI funding requested over the project period. This requirement signaled that the NCI funds were meant to leverage substantial external capital rather than serve as the sole source of support.
Who could provide third-party funding or partnering?
The FOA described third-party participation as coming from outside investors or strategic partners, such as venture investors, corporate partners, or other third-party funders.
Was a Commercialization Plan required?
Yes. Applicants were required to submit a Commercialization Plan consistent with NIH SBIR Phase II expectations, with specific attention to documenting third-party financing that had already been secured or was expected during the Bridge Award period.
What did the Commercialization Plan need to emphasize for this FOA?
In addition to standard NIH SBIR Phase II commercialization plan expectations, this FOA emphasized documenting third-party financing, including financing already secured and/or expected during the award period, aligned with a credible path to commercialization.
Was formal cost sharing or matching required?
No formal cost sharing or matching requirement was stated as a condition of the grant. However, the FOA included an expectation of third-party investment equal to or greater than the NCI funding requested, which effectively functioned as a leverage expectation in how applications were positioned.
How much total funding was estimated for this FOA?
The estimated total funding level was about $10,000,000.
How many awards were expected?
The FOA expected approximately 10 awards.
What was the maximum award amount?
The award ceiling was listed as $1,000,000.
What type of funding mechanism was this?
This was a discretionary grant opportunity.
What were the CFDA numbers associated with this FOA?
The program was listed under CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
Who was eligible to apply?
Eligibility was limited to United States small business concerns (SBCs) that met standard SBIR size and ownership rules at the time of the Phase I and Phase II awards. The applicant business had to be for-profit, based in the United States, and primarily operating in the United States (or otherwise making a significant contribution to the U.S. economy).
What legal forms of business were allowed?
The FOA indicated the business needed to be in an allowed legal form, such as an LLC or corporation, consistent with SBIR program requirements for U.S. small business concerns.
What were the ownership and control expectations?
The business generally needed to be at least 51% U.S.-owned and controlled by U.S. citizens or permanent residents, with specific rules noted for joint ventures.
What was the employee size limit for eligibility?
The business could have no more than 500 employees, including affiliates, consistent with SBA regulations in 13 C.F.R. Part 121.
Did the applicant need to have completed an NIH SBIR Phase II project?
Yes. The FOA was designed for small businesses seeking to advance cancer-related technologies that had already completed an NIH SBIR Phase II project into the next stage of development toward commercialization.
Could foreign components be included?
Yes. The FOA noted that foreign components, as NIH defines them, could be allowed. However, the applicant entity itself still needed to qualify as a U.S. small business concern.
What was the FOA reference number?
The reference details provided identify the FOA as RFA-CA-12-023.
When was the FOA posted?
The FOA was posted on August 17, 2012.
What was the application closing date?
The original and current closing date listed in the source record was March 6, 2013.
When was the FOA archived?
The archive date listed was April 6, 2013.
What was the overall intent of this funding pathway?
This was a time-limited NCI SBIR funding pathway intended for companies with validated Phase II progress that needed a commercialization-focused infusion of NIH support, closely tied to outside investment or strategic partnering, to complete major de-risking steps required for market entry in oncology therapeutics, imaging, devices, and diagnostics.
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