Opportunity Information: Apply for RFA HL 13 016
Apply for RFA HL 13 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research.
- This funding opportunity was created on Feb 17, 2012 and posted on Feb 17, 2012.
- Applicants must submit their applications by Jun 19, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NHLBI SBIR Phase IIB Bridge Award (R44), announced under Funding Opportunity Number RFA-HL-13-016, was designed to help small businesses push promising SBIR Phase II projects across the difficult, capital-intensive gap between late-stage R&D and real-world commercialization. In practical terms, this program targets the stage where a technology may be technically validated but still needs substantial funding and coordinated execution to reach milestones like regulatory submissions, manufacturing scale-up, pivotal testing, or other commercialization-critical steps. The National Heart, Lung, and Blood Institute (NHLBI) frames the award as a "bridge" specifically meant to accelerate that transition by encouraging formal partnerships between SBIR awardees and outside investors or strategic partners.
A central feature of this opportunity is the expectation of meaningful third-party financial participation. Applicants are required to submit a detailed Commercialization Plan that lays out the product development and market strategy, along with clear information about independent third-party funding that has already been secured or is expected during the Phase IIB Bridge project period. The program’s intent is that this non-federal, independent investment should be equal to or greater than the amount of NHLBI funding requested over the same period. In other words, NHLBI is using its award dollars to catalyze and de-risk commercialization, but it expects the applicant to bring substantial external backing to show market confidence and to ensure that the project is positioned to move quickly toward launch.
The scientific and clinical scope is tied directly to NHLBI’s mission areas, meaning the supported technologies must address heart, lung, blood, and sleep disorders and diseases. The associated CFDA program areas listed for this opportunity include 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), and 93.838 (Lung Diseases Research). The funded work can cover advanced preclinical development and/or clinical-stage development, depending on what is appropriate for the technology and what is needed to reach commercialization-relevant milestones. While clinical trials are allowed under this announcement, they are not mandatory; applicants can propose either preclinical packages or clinical studies as justified by the development pathway and remaining risks.
Another key requirement is that projects must be aimed at products that will ultimately need federal regulatory approval or clearance. This makes the program particularly relevant for regulated biomedical products such as drugs, biologics, medical devices, diagnostics, or other health technologies likely to interface with agencies like the FDA. Because of that emphasis, competitive proposals would typically be expected to show a credible regulatory strategy, an understanding of the evidence needed for clearance/approval, and a development plan aligned with regulatory expectations, even if the proposed work itself is not a formal clinical trial.
Administratively, this was a discretionary grant opportunity offered by the National Institutes of Health (NIH), with eligibility limited to small businesses. There was no cost sharing or matching requirement in the formal sense, but the third-party funding expectation effectively functions as a commercialization leverage requirement: NHLBI wants to see that outside capital is committed or strongly anticipated at a scale comparable to or exceeding the federal request. The opportunity was posted on February 17, 2012, with an original and current closing date listed as June 19, 2014, an archive date of July 20, 2014, and an estimated total funding amount of $5,000,000 across the program.
For reference and full details, the original announcement pointed applicants to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-016.html, and provided NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues. Overall, the Phase IIB Bridge Award mechanism is best understood as NHLBI’s way of backing late-stage SBIR projects that are ready to engage the market, with the explicit expectation that private or strategic capital will be part of the plan and that the project is marching toward a regulated commercial product in NHLBI’s disease areas.
FAQs: NHLBI SBIR Phase IIB Bridge Award (R44) - RFA-HL-13-016
What is the NHLBI SBIR Phase IIB Bridge Award (R44) meant to do?
This funding opportunity was designed to help small businesses move promising SBIR Phase II projects through the difficult, capital-intensive period between late-stage R&D and real-world commercialization. It targets projects that may be technically validated but still need significant funding and coordinated execution to reach commercialization-critical milestones such as regulatory submissions, manufacturing scale-up, pivotal testing, or other steps required to get a product to market.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is RFA-HL-13-016.
Which NIH institute offered this Bridge Award?
The program was offered by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health (NIH).
Who was eligible to apply?
Eligibility was limited to small businesses.
What stage of development is this award aimed at?
It is aimed at late-stage development, specifically the gap between late-stage R&D and commercialization. The work can include advanced preclinical development and/or clinical-stage development, depending on what is appropriate to reach commercialization-relevant milestones.
What kinds of milestones does NHLBI expect projects to pursue with this funding?
The opportunity description highlights milestones such as regulatory submissions, manufacturing scale-up, pivotal testing, and other commercialization-critical steps that help move a technology from development into the market.
Does the program require partnerships with investors or strategic partners?
The program is framed as a "bridge" that encourages formal partnerships between SBIR awardees and outside investors or strategic partners, and it places strong emphasis on meaningful third-party financial participation.
Is third-party (non-federal) funding required?
Applicants were required to provide clear information about independent third-party funding that had already been secured or was expected during the Phase IIB Bridge project period. The stated intent is that this non-federal, independent investment should be equal to or greater than the amount of NHLBI funding requested over the same period.
Is there an official cost sharing or matching requirement?
No formal cost sharing or matching requirement is described, but the third-party funding expectation effectively functions as a commercialization leverage requirement because NHLBI expects outside capital to be committed or strongly anticipated at a scale comparable to or exceeding the federal request.
What must be included in the application related to commercialization?
Applicants were required to submit a detailed Commercialization Plan describing the product development and market strategy. The plan also needed to include clear information about independent third-party funding that is secured or expected during the project period.
What scientific or clinical areas does this opportunity support?
The supported technologies must align with NHLBI mission areas, meaning they must address heart, lung, blood, and sleep disorders and diseases.
Which CFDA program areas were associated with this opportunity?
The CFDA program areas listed were 93.233 (National Center on Sleep Disorders Research), 93.837 (Cardiovascular Diseases Research), and 93.838 (Lung Diseases Research).
Are clinical trials required under this announcement?
No. Clinical trials were allowed, but they were not mandatory. Applicants could propose preclinical work and/or clinical studies, depending on the development pathway and remaining risks.
Are clinical trials allowed under this opportunity?
Yes. Clinical trials were allowed under this announcement, though not required.
Does the project need to involve a regulated product?
Yes. Projects must be aimed at products that will ultimately need federal regulatory approval or clearance. This makes the program particularly relevant for regulated biomedical products such as drugs, biologics, medical devices, diagnostics, or other health technologies likely to interface with agencies like the FDA.
What does NHLBI appear to expect regarding regulatory strategy?
Because the program emphasizes products requiring federal regulatory approval or clearance, competitive proposals would typically be expected to present a credible regulatory strategy, an understanding of the evidence needed for clearance/approval, and a development plan aligned with regulatory expectations, even if the proposed work is not itself a formal clinical trial.
What type of grant opportunity was this?
This was described as a discretionary grant opportunity offered by NIH, with the mechanism identified as an SBIR Phase IIB Bridge Award (R44).
When was this opportunity posted?
The opportunity was posted on February 17, 2012.
What was the closing date for applications?
The original and current closing date listed was June 19, 2014.
When was this opportunity archived?
The archive date listed was July 20, 2014.
How much total funding was estimated for this program?
The estimated total funding amount across the program was $5,000,000.
Where can applicants find the full original announcement?
The original announcement directed applicants to the NIH Grants Guide page at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-016.html
Who was listed as a contact for access or linking issues?
The announcement provided NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues.
What is the core idea behind calling it a "Bridge" award?
The award is described as a "bridge" because it is meant to accelerate the transition from late-stage SBIR-funded R&D into commercialization by combining NHLBI support with meaningful outside investment or strategic partner participation.
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