Support for Small Business Innovation Research (SBIR) to Develop New Technologies for Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R43/R44 Clinical Trial Not Allowed) | RFA DK 19 027

Opportunity Information: Apply for RFA DK 19 027

This opportunity is a National Institutes of Health (NIH) small business grant solicitation focused on improving technology for type 1 diabetes (T1D) therapy, specifically the devices and components that enable open-loop and closed-loop hormone replacement platforms. The announcement is titled "Support for Small Business Innovation Research (SBIR) to Develop New Technologies for Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R43/R44 Clinical Trial Not Allowed)" and it is issued under Funding Opportunity Number RFA-DK-19-027. It uses the SBIR mechanism with R43/R44 grants, meaning it is structured for small businesses to move from early feasibility and proof-of-concept work (Phase I) into more advanced development and commercialization-oriented R&D (Phase II), but it explicitly does not allow clinical trials under this FOA.

The core goal of the funding is to push forward new approaches that measurably improve glucose control technologies while reducing patient burden. In practical terms, NIH is looking for innovations that make diabetes management devices more accurate, safer, more effective, and easier to use. The emphasis is on novel devices or device components that can be integrated into open-loop systems (where insulin or other hormones are delivered based on preset plans with limited automation) and closed-loop systems (often referred to as artificial pancreas systems, where automated control algorithms adjust dosing based on real-time sensor data). Projects should represent genuine advances, not minor incremental tweaks, and they should address known limitations in current glucose control ecosystems such as sensor accuracy and reliability, dosing precision, system interoperability, user workload, and overall safety.

Because the focus is on "development and integration of novel components," the scope can include a wide range of enabling technologies that strengthen the performance of hormone replacement platforms. This may involve improved sensing, delivery, connectivity, control, or human factors elements, so long as the end result supports better integration into open- and closed-loop T1D therapy systems. The intent is to support work that leads to tangible device/component development outcomes, such as prototypes, bench validation, integration demonstrations, design refinements driven by performance testing, and other engineering milestones that position the technology for later-stage translation. Even though clinical trials are not permitted, the FOA is still geared toward development that increases real-world readiness, including safety and effectiveness considerations demonstrated through non-clinical testing and system-level validation work.

In terms of eligibility, the announcement is centered on SBIR, so small businesses are the primary applicants expected to apply. At the same time, the eligibility list provided for the opportunity is broad and includes various types of U.S.-based entities such as state, county, and local governments; certain public authorities; K-12 school districts; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education for those categories as stated); for-profit organizations other than small businesses; and other organization types. The FOA also explicitly highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. While these categories are listed as eligible, applicants still must align with NIH SBIR rules for the R43/R44 mechanism, which typically means the applicant organization for an SBIR award must be a qualifying U.S. small business concern, with other institutions often participating as subcontractors or collaborators as allowed under NIH policy.

Restrictions on foreign involvement are stated clearly. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, the FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed, which generally means limited, well-justified foreign activities may be permissible when they are essential to the project and appropriately disclosed and approved, even though the applicant organization itself must remain eligible and U.S.-based.

Administratively, this is a discretionary grant program under the NIH, with an activity area listed as Food and Nutrition, Health and a CFDA number of 93.847. The original closing date shown is November 3, 2020, and the record creation date is December 3, 2019. The award ceiling and expected number of awards are not specified in the provided data, which usually means applicants need to consult the full FOA text and NIH SBIR budget guidelines for limits, phase-specific caps, and any topic-specific budget expectations.

Overall, the opportunity is aimed at helping small businesses build the next generation of T1D hormone replacement platform components that improve accuracy and reduce burden, while supporting integration into open-loop and closed-loop systems. The strongest fit is development-focused R&D that can demonstrate meaningful performance, safety, and usability improvements through engineering and non-clinical validation, setting the stage for later regulatory and clinical pathways outside the scope of this specific "clinical trial not allowed" FOA.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Support for Small Business Innovation Research (SBIR) to Develop New Technologies for Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R43/R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2019-12-03.
• Applicants must submit their applications by 2020-11-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 19 027

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