Opportunity Information: Apply for RFA DK 13 001
Apply for RFA DK 13 001
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Small Business Innovation Research to Develop New Therapeutics and Monitoring Technologies for Type 1 Diabetes (T1D) Towards an Artificial Pancreas SBIR (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Dec 17, 2012 and posted on Dec 17, 2012.
- Applicants must submit their applications by Mar 6, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
This government grant opportunity, titled "Small Business Innovation Research to Develop New Therapeutics and Monitoring Technologies for Type 1 Diabetes (T1D) Towards an Artificial Pancreas SBIR (R43/R44)," is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) aimed specifically at small business concerns that are developing new technologies to improve care for people with type 1 diabetes. The central goal is to support research and development that helps move the field closer to an integrated, long-term system that can automatically regulate blood glucose by coordinating glucose monitoring with delivery of insulin and potentially other pancreatic hormones. In other words, the FOA is designed to accelerate progress toward practical artificial pancreas solutions by funding innovations that make these closed-loop or semi-closed-loop systems more accurate, reliable, and usable in real-world settings over extended periods.
The funding mechanism is the SBIR program under the R43/R44 framework, which is commonly used by NIH to support small companies through a phased development path. Phase I (R43) typically focuses on feasibility, early proof-of-concept work, and de-risking the scientific and engineering approach, while Phase II (R44) is generally intended for further development, refinement, and steps toward product readiness. The award type is a grant (not a contract), and it falls under discretionary funding. The activity categories listed emphasize health-related discovery and applied research, with ties to both technological innovation for human health and to the NIH institute mission areas covering diabetes, digestive, and kidney diseases.
The opportunity was posted on December 17, 2012, with an application deadline of March 6, 2013, and it was archived on April 6, 2013. The estimated total funding amount is listed as $2,500,000, indicating NIH anticipated supporting multiple projects or a limited number of larger efforts depending on award sizes and meritorious applications. There is no cost sharing or matching requirement, which reduces barriers for small businesses that may not have substantial non-federal capital available to commit upfront.
Eligibility is limited to small businesses, consistent with SBIR rules, and the FOA explicitly states that non-U.S. (foreign) entities are not eligible to apply, and that non-U.S. components of U.S. organizations are also not eligible. However, it notes that "foreign components" may be allowed as defined under the NIH Grants Policy Statement, meaning a U.S. small business applicant may be able to include certain foreign collaborations or elements if they meet NIH definitions and are justified scientifically, but the applicant organization itself must be domestic and meet SBIR eligibility requirements.
From a technical and programmatic standpoint, the FOA is oriented toward innovations that can enable or strengthen long-duration, glucose-regulated hormone delivery. That can include next-generation sensing and monitoring technologies, improved algorithms and control approaches, safer and more responsive delivery mechanisms, better system integration, and other enabling therapeutics or components that reduce hypoglycemia risk, improve time-in-range, and support durable performance outside controlled research environments. The emphasis on "integrated long term" systems highlights practical challenges such as sensor accuracy and drift over time, device reliability, user burden, calibration needs, biocompatibility, connectivity, and the robustness of control in the face of exercise, meals, illness, and day-to-day variability in insulin sensitivity. Projects responsive to the FOA would be expected to show a clear line of sight from R and D to a component or system-level capability that measurably advances artificial pancreas functionality.
Administratively, the FOA is issued by NIH and is associated with the CFDA numbers 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health) and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The full announcement was available through the NIH grants guide at the provided link (RFA-DK-13-001). For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) webmaster email address, indicating that inquiries in this context are primarily about accessing the announcement or resolving linking problems rather than scientific questions about fit, which are typically handled by program staff listed within the full FOA.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Small Business Innovation Research to Develop New Therapeutics and Monitoring Technologies for Type 1 Diabetes (T1D) Towards an Artificial Pancreas SBIR (R43/R44)."
Who is offering this funding opportunity?
This is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA).
What is the main purpose of this FOA?
The FOA is intended to support small businesses developing new technologies that improve care for people with type 1 diabetes, with an emphasis on advancing practical artificial pancreas solutions.
What does the FOA mean by an "artificial pancreas" goal?
The FOA focuses on progress toward an integrated, long-term system that can automatically regulate blood glucose by coordinating glucose monitoring with delivery of insulin and potentially other pancreatic hormones (closed-loop or semi-closed-loop systems).
What types of organizations are eligible to apply?
Eligibility is limited to small business concerns, consistent with SBIR program rules.
Are non-U.S. (foreign) organizations eligible to apply?
No. The FOA states that non-U.S. (foreign) entities are not eligible to apply.
Can a U.S. small business include non-U.S. parts of its organization in the project?
No. The FOA indicates that non-U.S. components of U.S. organizations are not eligible.
Are any foreign activities allowed at all under this FOA?
The FOA notes that "foreign components" may be allowed as defined under the NIH Grants Policy Statement. This suggests certain foreign collaborations or elements may be included if they meet NIH definitions and are scientifically justified, but the applicant organization must be a domestic small business that meets SBIR eligibility requirements.
What funding mechanism does this opportunity use?
This opportunity uses the SBIR program under the NIH R43/R44 framework.
What is the difference between Phase I (R43) and Phase II (R44) in this FOA?
Phase I (R43) typically supports feasibility and early proof-of-concept work to reduce scientific and engineering risk. Phase II (R44) generally supports further development, refinement, and steps toward product readiness.
Is this funding a grant or a contract?
The award type is a grant (not a contract).
What is the total estimated funding amount?
The estimated total funding amount is $2,500,000.
Does this FOA require cost sharing or matching funds?
No. The opportunity states there is no cost sharing or matching requirement.
When was the FOA posted, and what were the key dates?
The FOA was posted on December 17, 2012. The application deadline was March 6, 2013. The opportunity was archived on April 6, 2013.
What does it mean that the opportunity is archived?
Based on the information provided, "archived" indicates the FOA is no longer active for new submissions under the listed deadline timeline.
What kinds of projects is NIH trying to fund through this FOA?
The FOA is oriented toward innovations that enable or strengthen long-duration, glucose-regulated hormone delivery. This includes technology and R&D that improves the accuracy, reliability, and usability of artificial pancreas-related systems over extended periods in real-world settings.
What specific technology areas are highlighted as relevant?
The FOA highlights next-generation sensing and monitoring technologies, improved algorithms and control approaches, safer and more responsive delivery mechanisms, better system integration, and other enabling therapeutics or components that improve performance and safety.
What real-world challenges does the FOA emphasize for long-term, integrated systems?
The FOA emphasizes practical challenges such as sensor accuracy and drift over time, device reliability, user burden, calibration needs, biocompatibility, connectivity, and robust control despite exercise, meals, illness, and day-to-day variability in insulin sensitivity.
What outcomes or benefits are these innovations expected to support?
The FOA points toward reducing hypoglycemia risk, improving time-in-range, and enabling durable performance outside controlled research environments.
Does the FOA focus only on full artificial pancreas systems, or can it support components?
Based on the description, projects should show a clear line of sight to a component or system-level capability that measurably advances artificial pancreas functionality, which indicates component-level innovations can be responsive when they meaningfully improve the overall goal.
What are the activity categories associated with this FOA?
The activity categories emphasize health-related discovery and applied research, with ties to technological innovation to improve human health and NIH mission areas related to diabetes, digestive, and kidney diseases.
What CFDA numbers are associated with this opportunity?
The FOA is associated with CFDA 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health) and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
What is the FOA identifier or reference provided?
The announcement is referenced as RFA-DK-13-001.
Where was the full announcement made available?
The full announcement was available through the NIH grants guide at the provided link for RFA-DK-13-001.
Who should be contacted for access or technical issues with the posting?
For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) webmaster email address.
Are the listed contacts intended for scientific fit questions?
The information provided indicates the listed contact in this context is primarily for access/linking problems, not scientific questions about project fit (which are typically handled by program staff listed within the full FOA).
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