Opportunity Information: Apply for RFA HL 14 012
Apply for RFA HL 14 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Small Market Awards SBIR Phase IIB Competing Renewals for Heart, Lung, Blood and Sleep Technologies with Small Commercial Markets (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 93.350 National Center for Advancing Translational Sciences 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research.
- This funding opportunity was created on Apr 16, 2013 and posted on Apr 16, 2013.
- Applicants must submit their applications by Jun 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
This funding opportunity, titled "Small Market Awards SBIR Phase IIB Competing Renewals for Heart, Lung, Blood and Sleep Technologies with Small Commercial Markets (R44)" (Funding Opportunity Number RFA-HL-14-012), is a National Institutes of Health (NIH) grant program run through the National Heart, Lung, and Blood Institute (NHLBI). It is designed specifically for small businesses that have already received an NHLBI SBIR Phase II award and now need additional, later-stage support to push an NHLBI-mission technology forward when the commercial market is relatively small. The program is aimed at technologies that serve rare diseases or very young pediatric populations, where traditional investors may be hesitant because patient populations are limited and the path to revenue can be slower or less predictable.
The core purpose of the award is "de-risking" a technology so it becomes more attractive for private investment or other non-NHLBI funding after the federal support ends. In practice, that means applicants are expected to propose a clear development plan that reduces key scientific, technical, clinical, manufacturing, and regulatory uncertainties that commonly block commercialization. A central requirement is a Commercialization Plan, which is not a generic business write-up but a detailed explanation of how the company expects to move the product toward market adoption, including milestones, market rationale, regulatory strategy, and the funding strategy needed to finish development beyond the grant.
A major feature of this FOA is the expectation of independent third-party financial participation during the project period. Applicants must describe any outside funding already secured or reasonably anticipated (for example, investments, strategic partnerships, foundations, disease organizations, or other non-federal sources). The FOA sets an explicit expectation that this independent third-party funding will be equal to or greater than one-third of the total NHLBI funds requested over the life of the project. This requirement signals that NHLBI wants to see both external validation of the project and a credible plan for what happens when the grant ends, with the broader goal of ensuring the technology can continue advancing without relying on ongoing federal SBIR support.
The technologies proposed under this program must be the type that will ultimately require U.S. federal regulatory approval or clearance. This implies products such as medical devices, diagnostics, therapeutics, or combination products that fall under FDA oversight, and it shapes the kind of work the award will support. Projects may cover preclinical development (such as validation studies, performance testing, safety work, or design refinement) and/or clinical stages (such as feasibility studies or other clinical evaluations). Clinical trials are allowed when appropriate for the product and stage of development, but they are not mandatory, meaning the program can fund non-trial activities that are still essential to reaching a regulatory submission and a commercially viable product.
Administratively, the opportunity is categorized as a discretionary grant using the SBIR Phase IIB competing renewal mechanism under the R44 activity code, and it is limited to eligible small business applicants. There is no cost sharing or matching requirement beyond the program's practical expectation for third-party funding participation described above. The opportunity was posted April 16, 2013, with an original and final closing date of June 19, 2015, and it was archived July 20, 2015. The estimated total funding amount listed for the opportunity is $2,000,000. It is associated with multiple CFDA program areas relevant to NHLBI and related NIH priorities, including cardiovascular diseases research (93.837), lung diseases research (93.838), and sleep disorders research (93.233), as well as translational science (93.350), reflecting the program's focus on moving technologies across the development gap toward real-world clinical use.
In short, this FOA supported small businesses that were already beyond early SBIR development and needed Phase IIB-level resources to reach a regulatory-ready, investment-ready stage for heart, lung, blood, and sleep-related technologies serving rare or pediatric populations. The NHLBI funding was meant to bridge a commercialization gap, but only in situations where the company could show a realistic path to market and credible third-party financial support during the award period, ensuring the project could continue advancing after NHLBI support concludes.
Frequently Asked Questions (FAQs)
What is the official title of this funding opportunity?
The opportunity is titled "Small Market Awards SBIR Phase IIB Competing Renewals for Heart, Lung, Blood and Sleep Technologies with Small Commercial Markets (R44)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HL-14-012.
Which agency and institute run this program?
This is a National Institutes of Health (NIH) program run through the National Heart, Lung, and Blood Institute (NHLBI).
What type of award mechanism is used?
It is a discretionary grant using the SBIR Phase IIB competing renewal mechanism under the R44 activity code.
Who is this opportunity designed for?
It is designed specifically for eligible small business applicants that have already received an NHLBI SBIR Phase II award and are seeking later-stage support to advance an NHLBI-mission technology.
What kinds of markets is this program meant to support?
This FOA targets technologies with relatively small commercial markets, especially those serving rare diseases or very young pediatric populations where traditional investment can be harder to secure due to limited patient populations and less predictable or slower revenue paths.
What is the main purpose of the award?
The core purpose is to "de-risk" the technology so it becomes more attractive for private investment or other non-NHLBI funding after the federal support ends.
What does "de-risking" mean in practical terms for applicants?
Applicants are expected to propose a clear development plan that reduces key uncertainties that commonly block commercialization, including scientific, technical, clinical, manufacturing, and regulatory risks.
Is a Commercialization Plan required?
Yes. A central requirement is a Commercialization Plan.
What is expected to be included in the Commercialization Plan?
The Commercialization Plan is expected to go beyond a generic business summary and explain how the company expects to move the product toward market adoption. Based on the FOA description, this includes milestones, market rationale, regulatory strategy, and the funding strategy needed to complete development beyond the grant.
Is third-party funding required?
The FOA includes an expectation of independent third-party financial participation during the project period. Applicants must describe outside funding already secured or reasonably anticipated.
How much third-party funding is expected relative to the NHLBI request?
The FOA sets an explicit expectation that independent third-party funding will be equal to or greater than one-third of the total NHLBI funds requested over the life of the project.
What counts as independent third-party financial participation under this FOA?
The FOA description gives examples such as investments, strategic partnerships, foundations, disease organizations, or other non-federal sources.
Why does the program emphasize third-party participation?
It is intended to show external validation of the project and a credible plan for what happens when the grant ends, with the broader goal of helping ensure the technology can keep advancing without relying on ongoing federal SBIR support.
Does this FOA require formal cost sharing or matching funds?
No. There is no cost sharing or matching requirement beyond the program's practical expectation for third-party funding participation described in the FOA summary.
What kinds of technologies are eligible under this program?
The technologies must be ones that will ultimately require U.S. federal regulatory approval or clearance. The description indicates this can include medical devices, diagnostics, therapeutics, or combination products that fall under FDA oversight.
What stages of development can the award support?
Projects may cover preclinical development and/or clinical stages. Examples mentioned include validation studies, performance testing, safety work, and design refinement, as well as feasibility studies or other clinical evaluations.
Are clinical trials required?
No. Clinical trials are allowed when appropriate for the product and stage of development, but they are not mandatory. The program can also fund non-trial activities that are still essential to reaching a regulatory submission and a commercially viable product.
What is the overarching commercialization goal of the FOA?
The intent is to bridge a commercialization gap for later-stage SBIR projects so they become regulatory-ready and investment-ready, particularly where the market is small and follow-on capital may be difficult to obtain.
What is the estimated total funding amount listed for this opportunity?
The estimated total funding amount listed is $2,000,000.
When was this funding opportunity posted and when did it close?
It was posted on April 16, 2013. The original and final closing date was June 19, 2015.
Is this opportunity still open?
No. The opportunity was archived on July 20, 2015.
Which research and program areas (CFDA numbers) are associated with this FOA?
The FOA is associated with multiple CFDA program areas relevant to NHLBI and related NIH priorities, including cardiovascular diseases research (93.837), lung diseases research (93.838), sleep disorders research (93.233), and translational science (93.350).
What disease or clinical focus areas does this FOA emphasize?
It focuses on heart, lung, blood, and sleep-related technologies, with a particular emphasis on products serving rare diseases or very young pediatric populations and aligned with NHLBI mission areas.
What must applicants explain about post-grant funding?
Applicants are expected to present a credible funding strategy for completing development beyond the grant, including how the project will continue advancing after NHLBI support concludes and how it will attract private investment or other non-NHLBI funding.
What kinds of barriers is the FOA trying to help companies overcome?
The FOA is aimed at reducing the types of uncertainties that often block commercialization, including technical readiness, clinical evidence needs, manufacturing preparedness, and regulatory pathway clarity, especially in cases where traditional investors may be hesitant due to limited market size.
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