Opportunity Information: Apply for RFA HL 16 009
Apply for RFA HL 16 009
- 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 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Feb 25, 2015 and posted on Feb 25, 2015.
- Applicants must submit their applications by Jun 19, 2017. (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 $3,000,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
This funding opportunity, RFA-HL-16-009, is a National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) Small Business Innovation Research (SBIR) Phase IIB "Bridge Award" mechanism (R44) designed to push promising SBIR/STTR Phase II projects over the most expensive and risk-heavy hurdles that typically stand between a successful prototype or proof-of-concept and a commercial product. The central goal is to accelerate commercialization for technologies that address heart, lung, blood, and sleep disorders and diseases, including work aligned with NHLBI program areas such as cardiovascular disease, lung disease, blood diseases and resources, and sleep disorders research. In practical terms, the program is meant to help small businesses complete major value-inflection activities like advanced preclinical development, clinical validation steps when appropriate, manufacturing scale-up planning, quality systems, and other late-stage development work that positions a technology for market entry.
A defining feature of the Phase IIB Bridge Award is the expectation of meaningful private or non-federal participation in funding the project. Applicants are required to submit a detailed Commercialization Plan, and that plan must spell out what independent third-party funding has already been secured and/or what is realistically expected during the Phase IIB project period. NHLBI is not looking to be the only major source of capital at this stage; instead, the program is structured to "bridge" NIH support with investor or strategic partner support. The opportunity explicitly states that the level of independent third-party funding is expected to be equal to or greater than the amount of NHLBI funding requested over the award period. This requirement is meant to demonstrate market interest and reduce the gap between federally funded R&D and a product that is ready for customers, payers, and clinical adoption.
Projects must fit the NHLBI mission and must be technologies that will ultimately require federal regulatory approval or clearance. That generally implies a pathway involving agencies such as the U.S. Food and Drug Administration (FDA) for drugs, biologics, devices, diagnostics, digital health products with regulated claims, or other regulated medical technologies. The FOA allows proposed work to be at either the preclinical stage, the clinical stage, or a combination, depending on what is most appropriate for the product and where it sits in development. Clinical trials can be included in the proposal if they make sense for the commercialization plan, but they are not mandatory; the program can support other critical commercialization enabling work that moves a technology toward regulatory submission, clearance/approval, and market readiness.
From an administrative standpoint, this is a discretionary grant program using the SBIR Phase IIB Bridge Award (R44) funding instrument. The award ceiling listed for the opportunity is $3,000,000, indicating it is intended for larger, capital-intensive efforts typical of late-stage translational development. There is no cost sharing or matching requirement in the traditional sense, but the program does effectively require substantial third-party funding as part of the bridge award model, and applicants should be prepared to document and justify those commitments or well-supported expectations in their commercialization plan and supporting materials.
Eligibility is limited to small businesses. Non-U.S. (foreign) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components as defined by NIH policy may be permitted in some cases, meaning limited foreign involvement might be allowable if it meets NIH requirements and is properly justified, but the applicant organization itself must be an eligible U.S. small business. The opportunity was posted February 25, 2015, and the final listed closing date was June 19, 2017 (it is archived as of July 20, 2017), which means it is not currently open under this specific announcement, though similar bridge award opportunities may appear under newer NHLBI FOAs.
Overall, the program is best understood as a commercialization-focused extension for strong SBIR/STTR Phase II projects that are ready to attract outside capital and need a final, well-structured push to complete regulatory-aligned development and position the product for launch. The emphasis on a rigorous commercialization plan and third-party funding is intentional: NHLBI is using its dollars to de-risk and accelerate technologies that already show credible market pull and partner interest, with the end goal of getting regulated heart, lung, blood, and sleep health solutions into real-world use faster.
Frequently Asked Questions (FAQs) - RFA-HL-16-009 (NHLBI SBIR Phase IIB Bridge Award, R44)
What is RFA-HL-16-009?
RFA-HL-16-009 is a National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) Small Business Innovation Research (SBIR) Phase IIB "Bridge Award" funding opportunity using the R44 mechanism. It is intended to help push promising SBIR/STTR Phase II projects past late-stage, high-cost development hurdles on the path to commercialization.
What is the purpose of the SBIR Phase IIB Bridge Award (R44) described here?
The central purpose is to accelerate commercialization of technologies addressing heart, lung, blood, and sleep disorders and diseases by funding late-stage development work that typically sits between a prototype/proof-of-concept and a market-ready product.
What kinds of technologies are in scope for this opportunity?
Technologies must fit the NHLBI mission and address heart, lung, blood, and sleep disorders and diseases. The opportunity references alignment with NHLBI program areas such as cardiovascular disease, lung disease, blood diseases and resources, and sleep disorders research.
Does the project need to require regulatory approval or clearance?
Yes. The opportunity specifies that supported technologies are expected to ultimately require federal regulatory approval or clearance. This generally implies a pathway involving agencies such as the U.S. Food and Drug Administration (FDA) for regulated medical products (for example, drugs, biologics, devices, diagnostics, or regulated digital health products with regulated claims).
What stage of development can be proposed (preclinical vs. clinical)?
The FOA allows work at the preclinical stage, the clinical stage, or a combination of both, depending on what is most appropriate for the product and where it is in development.
Are clinical trials required?
No. Clinical trials may be included if they make sense for the commercialization plan, but they are not mandatory. The program can also support other late-stage activities that move a technology toward regulatory submission, clearance/approval, and market readiness.
What types of activities is this funding meant to support?
The program is positioned to support major value-inflection activities that help a technology reach market entry readiness. Examples described include advanced preclinical development, clinical validation steps when appropriate, manufacturing scale-up planning, quality systems, and other late-stage development work tied to commercialization and regulatory progress.
How is this award different from earlier-stage SBIR/STTR funding?
This Bridge Award is framed as a commercialization-focused extension for strong SBIR/STTR Phase II projects. It is specifically designed to address the expensive and risk-heavy hurdles that remain after proof-of-concept/prototype work, when a company is aiming to complete regulatory-aligned development and prepare for launch.
What is the funding instrument/mechanism?
This is a discretionary grant program using the SBIR Phase IIB Bridge Award (R44) funding instrument.
What is the maximum award amount under this opportunity?
The listed award ceiling for this opportunity is $3,000,000, reflecting the expectation that supported efforts may be larger and capital-intensive due to their late-stage translational and commercialization focus.
Is third-party funding required?
Yes, meaningful private or non-federal participation is a defining feature. Applicants are expected to have secured and/or to realistically expect independent third-party funding during the Phase IIB project period.
How much third-party funding is expected relative to the NHLBI request?
The opportunity explicitly states that the level of independent third-party funding is expected to be equal to or greater than the amount of NHLBI funding requested over the award period.
Is this the same as cost sharing or matching?
Not in the traditional cost sharing/matching sense. The opportunity notes there is no cost sharing or matching requirement in the traditional sense, but it does effectively require substantial independent third-party funding as part of the bridge award model.
What is the role of the Commercialization Plan?
A detailed Commercialization Plan is required. It must describe what independent third-party funding has already been secured and/or what is realistically expected during the Phase IIB project period, showing that NHLBI is not intended to be the only major source of capital at this stage.
Why does the FOA emphasize third-party funding?
The emphasis is intended to demonstrate market interest and reduce the gap between federally funded R&D and a product ready for customers, payers, and clinical adoption. The program is structured to "bridge" NIH support with investor or strategic partner support.
Who is eligible to apply?
Eligibility is limited to small businesses that meet SBIR eligibility requirements, and the applicant organization must be an eligible U.S. small business.
Are foreign (non-U.S.) entities eligible to apply?
No. Non-U.S. (foreign) entities are not eligible to apply under this opportunity.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible under this opportunity.
Are any foreign components allowed at all?
The opportunity notes that foreign components, as defined by NIH policy, may be permitted in some cases. Any limited foreign involvement would need to meet NIH requirements and be properly justified, while the applicant must still be an eligible U.S. small business.
Is this funding opportunity currently open?
No. The opportunity was posted on February 25, 2015, with a final listed closing date of June 19, 2017, and it is archived as of July 20, 2017. That means this specific announcement is not currently open, although similar bridge award opportunities may appear under newer NHLBI funding opportunity announcements (FOAs).
What is the overall goal NHLBI is trying to achieve with this Bridge Award?
The overall goal is to use NHLBI funds to help de-risk and accelerate technologies that show credible market pull and partner interest, enabling regulatory-aligned development and positioning products for commercialization so heart, lung, blood, and sleep health solutions can reach real-world use faster.
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