Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44 Clinical Trial Not Allowed) | RFA DK 18 022

Frequently Asked Questions (FAQs) - NIH SBIR RFA-DK-18-022

What is RFA-DK-18-022?

RFA-DK-18-022 is an NIH Small Business Innovation Research (SBIR) funding opportunity focused on advancing next-generation technologies for type 1 diabetes therapy and monitoring. It emphasizes innovations for both open-loop and closed-loop automated glucose control systems, including technologies used in automated hormone replacement approaches (such as artificial pancreas-type solutions).

What is the main goal of this funding opportunity?

The goal is to support small businesses developing new devices, device components, or enabling technologies that meaningfully improve glucose monitoring and management. NIH highlights improvements that increase accuracy and reliability while reducing the day-to-day burden on patients, with practical advances that translate into better safety and effectiveness in real-world use.

What kinds of technologies are in scope?

The opportunity targets improved glucose control technologies. Examples described in the announcement include advances in sensing, control algorithms, device integration, automation, interoperability of components, robustness in real-world settings, and design features that reduce patient workload and friction (such as fewer calibrations, more stable performance across conditions, simpler setup and wear, fewer alarms, and better handling of sensor or infusion set issues).

Does this FOA focus only on closed-loop "artificial pancreas" systems?

No. The FOA explicitly emphasizes both open-loop and closed-loop automated glucose control systems. It also references broader automated hormone replacement approaches, meaning the scope includes a range of automation levels and supporting technologies.

What does "Clinical Trial Not Allowed" mean for applicants?

It means the proposed project must not include clinical trials as defined by NIH (generally, prospective assignment of human participants to interventions to evaluate health-related outcomes). Applicants need to design the work so it stays outside that definition under this specific solicitation.

If clinical trials are not allowed, what kinds of evaluation activities can still be proposed?

Based on the description provided, projects can often include non-clinical approaches such as preclinical testing, benchtop validation, algorithm development, simulation, and other non-clinical evaluation strategies, as long as the overall project does not meet NIH's definition of a clinical trial for this FOA.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR rules.

Are foreign institutions eligible to apply?

No. Foreign institutions (non-U.S. entities) are explicitly not eligible to apply under this opportunity.

Can a U.S. small business with non-U.S. components apply as the applicant organization?

No. The opportunity states that non-U.S. components of U.S. organizations are also not eligible as applicant organizations. The core applicant must meet the domestic eligibility constraints described in the announcement.

Are any foreign activities allowed at all?

The FOA notes that "foreign components" may be allowed as defined in the NIH Grants Policy Statement. In practice, this suggests a U.S. small business may be able to include a limited, well-justified foreign component (such as a specialized service, unique resource, or collaboration) if permitted under NIH policy and appropriately justified in the application, while still keeping the applicant and primary work compliant with the stated domestic requirements.

What funding mechanism is used for this opportunity?

This is an SBIR grant solicitation using the R43/R44 pathway, which typically supports a phased approach to product development.

How do Phase I (R43) and Phase II (R44) relate to this FOA?

Phase I (R43) supports early feasibility and proof-of-concept efforts, while Phase II (R44) supports more advanced development toward a deployable product. The FOA is positioned to support progress along this development path, within the limits described (including the restriction against clinical trials).

What does NIH mean by seeking "real, practical advancements" rather than incremental tweaks?

The language in the opportunity signals NIH is looking for innovations that address persistent limitations affecting safety, effectiveness, adherence, or quality of life. The emphasis on enhanced accuracy and reduced patient burden suggests the agency wants meaningful improvements that matter outside the lab, not minor refinements that do not materially change outcomes or usability.

What types of improvements are especially encouraged?

The announcement highlights improvements that increase accuracy and reliability and reduce patient burden. It also references usability and human factors, such as reducing calibrations, simplifying setup and wear, reducing alarms, and improving how systems handle issues like sensor problems or infusion set issues.

Is the FOA interested in usability and human factors, or only engineering performance?

It is interested in both. The FOA calls out an audience that includes not only bioengineers and physiologists, but also bio-behavioral researchers and designers. This reflects interest in usability and human factors that determine whether a technology performs well in everyday settings.

What is the award ceiling listed for this opportunity?

The listed award ceiling is $300,000, indicating the funding level NIH expected for awards under this solicitation. Applicants would still need to follow NIH SBIR budget rules and any FOA-specific budget guidance.

How many awards does NIH expect to make?

The posting lists "Expected Awards" but does not provide a number in the information supplied here.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.847.

What type of funding is this categorized as?

It is categorized as discretionary funding and uses the grant funding instrument.

When was this FOA created and what closing date is listed?

The FOA was created on 2018-11-26 and lists an original closing date of 2019-03-21.

What is the main disease area and application focus?

The disease area is type 1 diabetes, with an application focus on technologies that improve glucose monitoring and management, including automated and semi-automated glucose control and hormone delivery strategies used in artificial pancreas-type solutions.