Opportunity Information: Apply for RFA DK 15 022

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Small Business Innovation Research (SBIR) to Develop New or Improved Closed Loop Automated Technologies for Diabetes Therapy and Monitoring (R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on Jul 24, 2015 and posted on Jul 24, 2015.
  • Applicants must submit their applications by Nov 18, 2015. (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:

The funding opportunity titled "Small Business Innovation Research (SBIR) to Develop New or Improved Closed Loop Automated Technologies for Diabetes Therapy and Monitoring (R43/R44)" (Funding Opportunity Number RFA-DK-15-022) was a National Institutes of Health (NIH) grant solicitation aimed at supporting small businesses working on next-generation diabetes technologies. The core purpose of the announcement was to encourage research and development that could move the field closer to practical, integrated, long-term closed-loop systems that automatically regulate blood glucose by controlling insulin and potentially other pancreatic hormones. In plain terms, the NIH was looking to fund enabling technologies that contribute to an "artificial pancreas" approach, where sensing, decision-making, and drug delivery are coordinated in a largely automated way to improve diabetes therapy and monitoring.

This FOA used the SBIR mechanism under the R43/R44 activity codes, which are commonly understood as the SBIR Phase I (R43) and Phase II (R44) grant pathways. Phase I generally supports early-stage proof-of-concept work, feasibility testing, and initial prototyping, while Phase II supports more advanced development, refinement, and steps toward commercialization and broader validation. The funding instrument type was a grant, and it fell under the broader funding activity category of health (with listing ties to the NIH institute responsible for diabetes and related conditions). The Catalog of Federal Domestic Assistance (CFDA) number associated with the program was 93.847, which corresponds to Diabetes, Digestive, and Kidney Diseases Extramural Research, indicating that this opportunity was aligned with the mission space typically overseen by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within NIH.

The opportunity emphasized innovation in closed-loop automated technologies for diabetes therapy and monitoring, specifically those that could advance integrated systems for glucose-regulated automated delivery of insulin and possibly additional pancreatic hormones. This focus implies a strong interest in improving the performance, reliability, safety, and usability of technologies that sit anywhere along the closed-loop pipeline, such as glucose sensing and monitoring, control algorithms and decision logic, automated drug delivery hardware, communication and interoperability between components, and integrated system design intended for long-term use. The underlying goal was to accelerate progress toward systems that can reduce the burden of daily diabetes management, improve glucose control, and potentially reduce acute and chronic complications by keeping blood glucose closer to target ranges with less manual intervention.

From an eligibility standpoint, the FOA was specifically limited to small businesses, consistent with the SBIR program purpose of stimulating technological innovation and strengthening the role of small companies in federally funded research and development with commercialization potential. Foreign institutions were not eligible to apply, and non-U.S. components of U.S. organizations were also not eligible. However, the announcement noted that foreign components, as defined under the NIH Grants Policy Statement, could be allowed, which typically means certain discrete project elements may be performed abroad when they are well-justified and meet NIH policy requirements, even though the applicant organization itself must be eligible and primarily U.S.-based.

Administratively, the opportunity was posted on July 24, 2015, with the original and current closing date listed as November 18, 2015, and an archive date of December 19, 2015, indicating it is no longer open for applications. The FOA stated that there was no cost sharing or matching requirement, which matters for small businesses because it means applicants were not required to contribute a specific percentage of non-federal funds to be eligible. The estimated total funding amount was listed as $2,500,000, suggesting NIH planned to support a limited number of awards or a targeted set of projects within that budget envelope, depending on application volume, scientific merit, and program priorities.

For applicants or stakeholders who needed the full official text, NIH provided an additional information link to the complete FOA on the NIH grants site (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-022.html). The contact information in the source data directed technical access or linking issues to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is typical for resolving problems accessing the electronic announcement rather than for scientific or grants management questions.

Overall, this grant opportunity represented a targeted NIH investment in small-business-driven R&D intended to push closed-loop diabetes management closer to robust, real-world artificial pancreas systems. It sought innovations that could materially improve automated monitoring and therapy, with an implicit expectation that successful projects could progress through SBIR phases toward commercialization and eventual clinical impact.

Frequently Asked Questions (FAQs)

What is the title of this funding opportunity?

The funding opportunity is titled "Small Business Innovation Research (SBIR) to Develop New or Improved Closed Loop Automated Technologies for Diabetes Therapy and Monitoring (R43/R44)."

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-DK-15-022.

Which agency offered this opportunity?

This was a National Institutes of Health (NIH) grant solicitation.

What is the main purpose of this FOA?

The purpose was to encourage small-business research and development that advances practical, integrated, long-term closed-loop systems for diabetes therapy and monitoring. These systems are designed to automatically regulate blood glucose by controlling insulin and potentially other pancreatic hormones.

What kind of technologies was NIH trying to advance through this FOA?

The FOA emphasized innovation in closed-loop automated technologies that support an "artificial pancreas" approach, where sensing, decision-making, and drug delivery work together in a largely automated way to improve diabetes therapy and monitoring.

What does "closed-loop" mean in the context of this opportunity?

In this context, "closed-loop" refers to an integrated approach in which glucose monitoring (sensing), control algorithms (decision-making), and drug delivery (such as insulin delivery) are coordinated so that glucose control can be adjusted automatically with less manual intervention.

What SBIR mechanisms/activity codes were used?

This FOA used the SBIR mechanism under the NIH activity codes R43/R44, commonly understood as SBIR Phase I (R43) and SBIR Phase II (R44).

What is typically supported under SBIR Phase I (R43) according to this description?

Phase I (R43) generally supports early-stage proof-of-concept work, feasibility testing, and initial prototyping.

What is typically supported under SBIR Phase II (R44) according to this description?

Phase II (R44) generally supports more advanced development and refinement, and steps toward commercialization and broader validation.

What type of funding instrument was this?

The funding instrument type was a grant.

Which NIH mission area or institute alignment is indicated?

The opportunity was aligned with NIH programs connected to diabetes and related conditions, with listing ties consistent with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

What is the CFDA number associated with this program?

The CFDA number was 93.847, corresponding to Diabetes, Digestive, and Kidney Diseases Extramural Research.

What parts of a closed-loop system could be relevant for proposed innovations?

Based on the description, relevant areas could include glucose sensing and monitoring, control algorithms and decision logic, automated drug delivery hardware, communication and interoperability between components, and integrated system designs intended for long-term use.

Was NIH only interested in insulin delivery, or also other hormones?

The description indicates interest in systems that automatically regulate blood glucose by controlling insulin and potentially other pancreatic hormones.

What overall impact was this FOA trying to achieve for diabetes management?

The underlying goal was to accelerate progress toward systems that reduce the burden of daily diabetes management, improve glucose control, and potentially reduce acute and chronic complications by keeping blood glucose closer to target ranges with less manual intervention.

Who was eligible to apply?

Eligibility was limited to small businesses, consistent with the SBIR program purpose of stimulating technological innovation and supporting commercialization-oriented R&D in small companies.

Were foreign institutions eligible to apply?

No. Foreign institutions were not eligible to apply.

Were non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations were also not eligible.

Are any foreign components allowed at all under this FOA?

The description notes that foreign components (as defined under the NIH Grants Policy Statement) could be allowed. This typically means discrete elements of a project may be performed abroad when well-justified and compliant with NIH policy, even though the applicant organization must be eligible and primarily U.S.-based.

Was cost sharing or matching required?

No. The FOA stated there was no cost sharing or matching requirement.

What was the estimated total funding amount?

The estimated total funding amount was $2,500,000.

When was the opportunity posted?

The opportunity was posted on July 24, 2015.

What was the closing date for applications?

The original and current closing date listed was November 18, 2015.

Is this funding opportunity still open?

No. The archive date was December 19, 2015, indicating the opportunity is no longer open for applications.

Where can someone find the full official FOA text?

The FOA text was available on the NIH grants site at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-022.html

Who was listed as the contact for technical access or linking issues?

For technical access or linking issues, the contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

What kind of projects did NIH appear to be prioritizing within the artificial pancreas space?

Based on the provided description, NIH appeared to prioritize enabling technologies that improve performance, reliability, safety, and usability of integrated closed-loop systems intended for long-term, real-world use.

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