Small Market Awards: SBIR Phase IIB Competing Renewals for Heart, Lung, Blood, and Sleep Technologies with Small Commercial Markets (R44) | Apply Online

Frequently Asked Questions (FAQs)

What is the Small Market Awards SBIR Phase IIB Competing Renewals opportunity (R44)?

This is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity designed to help small businesses advance promising biomedical technologies toward real-world use when the target commercial market is inherently small. It supports Phase IIB-level work under the SBIR mechanism (R44) and is focused on bridging a funding gap that can occur even after feasibility has been demonstrated.

Who is this funding opportunity intended for?

It is intended for eligible small businesses, specifically those that are existing Phase II SBIR or STTR awardees seeking a Phase IIB-level "competing renewal." In practical terms, it targets companies that have already proven feasibility through prior SBIR/STTR work and now need additional support to complete key validation steps.

What does "Phase IIB competing renewal" mean in this FOA?

"Competing renewal" indicates the award is meant for projects that previously received Phase II SBIR or STTR funding and are applying for additional, more advanced development support through a competitive process. This Phase IIB-level support is intended to help projects progress beyond earlier-stage feasibility and toward stronger validation and commercialization readiness.

What kinds of technologies or health areas does NHLBI want to support through this program?

The program targets technologies within NHLBI mission areas: heart, lung, blood, and sleep. It is aimed in particular at projects serving rare diseases or very young pediatric populations, where the commercial market is small even when the medical need is high.

Why does NHLBI offer this type of award for small commercial markets?

The rationale described is that rare-disease and pediatric technologies can be scientifically strong but may struggle to attract sufficient early private capital because the revenue potential is smaller and the time to market can be long. NHLBI uses this mechanism to help bridge the "valley of death" so the technology has enough technical and/or clinical validation to pursue later private investment or other non-federal financing after NIH support ends.

What stage of development is supported (preclinical vs. clinical)?

The FOA allows projects at either preclinical and/or clinical stages, depending on the technology's maturity and risk profile. The intent is to support the validation milestones that best position the technology for subsequent funding and regulatory steps.

Are clinical trials required under this opportunity?

No. Clinical trials can be included if they make sense for the proposed aims, but they are not mandatory. The program is described as flexible enough to support key validation work whether or not that includes a clinical trial.

Does the technology need to be something that will require FDA or other federal regulatory review?

Yes. The projects must be working toward a product that will ultimately require federal regulatory approval or clearance (for example, oversight by the U.S. Food and Drug Administration).

What is the most important application component called out in the description?

A central requirement is a detailed Commercialization Plan. Applicants are expected to present a credible path to market and show that the project fits into a broader financing strategy rather than relying solely on NHLBI funding.

What are the third-party funding expectations for applicants?

Applicants must describe independent third-party funding that has already been secured or is realistically expected during the project period. NHLBI expects this outside support to be substantial: it should be at least equal to one-third of the total NHLBI funds requested over the life of the award.

What counts as the outside funding requirement in this summary?

The description specifies "independent third-party funding" and emphasizes that it should already be secured or realistically expected during the project period. No additional categories or examples are provided in the text beyond that.

What is the funding ceiling for this opportunity?

The award ceiling listed is $3,000,000.

Which agency and institute sponsor this funding opportunity?

This is a discretionary grant mechanism offered by HHS/NIH through the National Heart, Lung, and Blood Institute (NHLBI).

What is the funding opportunity number?

The funding opportunity number is RFA-HL-17-012.

Which CFDA numbers are associated with this opportunity?

The opportunity is listed under CFDA numbers 93.233, 93.350, 93.837, 93.838, 93.839, and 93.840.

When was this opportunity posted and when did it close (per the source data)?

It was originally created and posted on April 18, 2016, with a closing date of June 20, 2018 (as listed in the source data).

What is the overall goal of the program by the time NHLBI support ends?

The goal is that, by the end of NHLBI support, the project will have enough technical and/or clinical validation to continue advancing through private funding or other non-federal financing, making it more attractive for later investment and enabling continued progress toward regulatory milestones and real-world use.

What types of projects are a strong fit based on the description provided?

Strong-fit projects are those that (1) are within heart, lung, blood, or sleep mission areas; (2) address rare diseases or very young pediatric populations with small commercial markets; (3) have already demonstrated feasibility through prior SBIR or STTR work; (4) need Phase IIB-level support to complete validation steps; (5) include a credible commercialization plan; and (6) can show meaningful independent third-party funding at the level described.