Opportunity Information: Apply for RFA DK 21 011
The grant 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)" is a National Institutes of Health (NIH) SBIR funding announcement aimed specifically at small businesses that are developing next-generation technologies for type 1 diabetes (T1D) management. The focus is on research and early product development that can lead to practical device improvements or new device components that meaningfully advance glucose control and make diabetes therapy safer, more effective, and less burdensome for patients. It is positioned as a device and platform-enabling opportunity rather than basic science funding, and it is centered on innovations that can be integrated into open-loop and closed-loop hormone replacement systems, meaning both systems where insulin (and potentially other hormones) delivery is manually guided and systems where dosing is automated using sensor-driven control algorithms.
A key theme in this announcement is improving accuracy and reducing patient burden. In practice, that points to technologies that can improve the reliability and performance of glucose control tools, reduce the amount of manual input required from users, simplify calibration or maintenance, reduce wear-time hassles, and lower the day-to-day cognitive load of living with T1D. The FOA is looking for work that would represent real advancements in safety and effectiveness, which generally implies more than incremental tweaks. Applicants are expected to pursue innovations that can demonstrably improve clinical-relevant performance characteristics of glucose control technologies and make integration into broader hormone replacement platforms easier and more robust. Because the announcement explicitly mentions "development and integration of novel components," it supports efforts that could involve new sensors, improved insulin delivery components, algorithm-enabling modules, interoperability features, safety layers, communication methods, power management improvements, or other device subsystems that strengthen the overall performance of open- and closed-loop solutions.
The funding mechanism is SBIR under the NIH R43/R44 pathway, which is commonly used to support small business innovation in two stages: Phase I (R43) typically supports feasibility and proof-of-concept work, while Phase II (R44) supports more advanced R&D leading toward a prototype, product refinement, and readiness for later-stage commercialization efforts. The announcement is explicitly labeled "Clinical Trial Not Allowed," meaning the proposed research cannot include a clinical trial as defined by NIH. In practical terms, this generally steers applicants toward engineering development, benchtop testing, preclinical verification, simulation work, usability-oriented development that does not meet the NIH definition of a clinical trial, and other non-clinical validation activities intended to de-risk the technology. Projects can still be highly translational and product-driven, but they must stay within the non-clinical-trial boundary set by the FOA.
Eligibility is limited to small businesses, consistent with SBIR program rules, and the opportunity excludes non-U.S. entities from applying. Foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply as part of the applicant organization. However, the announcement notes that "foreign components" may be allowed as defined in the NIH Grants Policy Statement, which typically means certain discrete project elements may be performed outside the U.S. if strongly justified and permitted under NIH policy, but the applicant itself must be an eligible U.S. small business and must comply with all NIH requirements regarding foreign involvement.
From an administrative standpoint, the opportunity is listed as a discretionary grant, with activity areas in health (and related classifications including food and nutrition) and is tied to CFDA number 93.847. The funding opportunity number is RFA-DK-21-011, reflecting its NIH institute alignment (the "DK" identifier is associated with the National Institute of Diabetes and Digestive and Kidney Diseases). The opportunity was created on 2021-05-06 and had an original closing date of 2022-10-07. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would typically need to consult the full FOA text for budget caps, project period limits, and other funding details that often vary by SBIR phase and NIH institute policy.
Overall, this FOA is designed for U.S. small businesses that are building tangible, integratable technology advances for T1D glucose control systems, especially components that can strengthen open-loop and closed-loop hormone replacement platforms by improving accuracy, safety, and user experience, while staying in the non-clinical-trial development space typical of early-stage device innovation and readiness work.Apply for RFA DK 21 011
- 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 2021-05-06.
- Applicants must submit their applications by 2022-10-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity 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)."
Which agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) funding announcement under the SBIR program.
What is the funding opportunity number?
The funding opportunity number is RFA-DK-21-011.
Which NIH institute is this aligned with?
Based on the "DK" identifier in the opportunity number, it is aligned with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What kind of grant mechanism does this use?
This uses the NIH SBIR R43/R44 pathway, which is commonly structured as Phase I (R43) for feasibility/proof-of-concept and Phase II (R44) for more advanced R&D toward prototype development and commercialization readiness.
What is the overall purpose of this opportunity?
The purpose is to support small businesses developing next-generation technologies for type 1 diabetes (T1D) management, specifically technologies that enable practical device improvements or new device components that advance glucose control and make therapy safer, more effective, and less burdensome for patients.
Is this opportunity focused on basic science or device/product development?
It is positioned as device and platform-enabling support rather than basic science funding, with an emphasis on research and early product development that can lead to practical improvements and integratable components.
What types of T1D systems does this opportunity target?
It targets innovations that can be integrated into both open-loop and closed-loop hormone replacement systems for T1D therapy. Open-loop generally refers to systems where dosing is manually guided, while closed-loop refers to automated dosing using sensor-driven control algorithms.
What is meant by "development and integration of novel components"?
It means the FOA supports work to create and integrate new or improved subsystems that strengthen open- and closed-loop hormone replacement platforms, with an emphasis on integratability and robust performance in real-world use.
What kinds of technologies or components are in scope?
Based on the description provided, in-scope efforts could include innovations such as new sensors, improved insulin delivery components, algorithm-enabling modules, interoperability features, safety layers, communication methods, power management improvements, and other device subsystems that improve overall platform performance.
What are the main technical themes or priorities in this FOA?
A key theme is improving accuracy and reducing patient burden. That includes improving reliability and performance of glucose control tools, reducing manual input, simplifying calibration or maintenance, reducing wear-time hassles, and lowering the day-to-day cognitive load of living with T1D.
Does the FOA favor incremental improvements or more substantial advances?
The description emphasizes "real advancements" in safety and effectiveness and suggests interest in improvements beyond incremental tweaks, with demonstrable gains in clinically relevant performance characteristics and integratability.
Are clinical trials allowed under this opportunity?
No. The announcement is explicitly labeled "Clinical Trial Not Allowed," meaning the proposed research cannot include a clinical trial as defined by NIH.
If clinical trials are not allowed, what kinds of work are still appropriate?
The description indicates this steers applicants toward non-clinical-trial activities such as engineering development, benchtop testing, preclinical verification, simulation work, and usability-oriented development that does not meet the NIH definition of a clinical trial.
Can projects still be translational and product-driven even if clinical trials are not allowed?
Yes. The opportunity is described as highly translational and product-driven, as long as the work stays within the non-clinical-trial boundary set by the FOA.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR program rules.
Are non-U.S. entities eligible to apply?
No. The opportunity excludes non-U.S. entities from applying. Foreign institutions are not eligible to apply.
Can a U.S. organization include non-domestic components as part of the applicant organization?
No. Non-domestic components of U.S. organizations are not eligible to apply as part of the applicant organization.
Are any foreign activities allowed at all?
The description notes that "foreign components" may be allowed as defined in the NIH Grants Policy Statement. This typically means certain discrete project elements may be performed outside the U.S. if strongly justified and permitted under NIH policy, while the applicant must remain an eligible U.S. small business.
What type of award is this classified as?
It is listed as a discretionary grant.
What are the activity areas associated with this opportunity?
The activity areas are listed in health (and related classifications including food and nutrition).
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.847.
When was this opportunity created, and what was the closing date?
The opportunity was created on 2021-05-06 and had an original closing date of 2022-10-07.
Does the provided information state the award ceiling or the expected number of awards?
No. The provided source information does not specify an award ceiling or the expected number of awards. The description notes applicants would typically consult the full FOA text for budget caps, project period limits, and other funding details that often vary by SBIR phase and NIH institute policy.
What is the intended outcome of supported projects?
The intended outcome is tangible, integratable technology advances for T1D glucose control systems, especially components that improve accuracy, safety, and user experience for open-loop and closed-loop hormone replacement platforms, while remaining in the non-clinical-trial development space.
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| Characterization of Islet-derived Extracellular Vesicles for Improved Detection, Monitoring, Classification, and Treatment of Type 1 Diabetes (R01 Clinical Trial Not Allowed) Apply for RFA DK 21 016 Funding Number: RFA DK 21 016 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Support for Small Business Innovation Research (SBIR) to Develop New Methods and Technologies for Assessment of Risk and for Early Diagnosis and Prognosis of Type 1 Diabetes (R43/R44 Clinical Trial Not Allowed) Apply for RFA DK 21 021 Funding Number: RFA DK 21 021 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Identification and Characterization of Bioactive Microbial Metabolites for Advancing Research on Microbe-Diet-Host Interactions Knowledgebase Management Center (U24 Clinical Trial Not Allowed) Apply for RFA DK 21 014 Funding Number: RFA DK 21 014 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 002 Funding Number: RFA DK 21 002 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) Apply for RFA HL 22 014 Funding Number: RFA HL 22 014 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Continuation of The Collaborative Islet Transplantation Registry (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 013 Funding Number: RFA DK 21 013 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Biostatistics Research Center (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 003 Funding Number: RFA DK 21 003 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $25,000,000 |
| Pilot and Feasibility Studies to Improve Technology Adoption and Reduce Health Disparities in Type 1 Diabetes Mellitus (R01 Clinical Trial Required) Apply for RFA DK 21 018 Funding Number: RFA DK 21 018 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Cardiovascular Biorepository for Type 1 Diabetes (U24 Clinical Trial Not Allowed) Apply for RFA DK 21 010 Funding Number: RFA DK 21 010 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
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| High-Resolution Exploration of the Human Islet Tissue Environment [HIRN Human Pancreas Analysis Consortium (HPAC)] (U01 - Clinical Trial Not Allowed) Apply for RFA DK 21 017 Funding Number: RFA DK 21 017 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed) Apply for RFA DK 21 503 Funding Number: RFA DK 21 503 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $6,300,000 |
| Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional) Apply for PAR 21 313 Funding Number: PAR 21 313 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $125,000 |
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