Opportunity Information: Apply for RFA DK 11 018
Apply for RFA DK 11 018
- The National Institutes of Health in the food and nutrition health income security and social services 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 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Nov 23, 2011 and posted on Sep 20, 2011.
- Applicants must submit their applications by Nov 28, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 owned and controlled by another for profit business concern that is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
This funding opportunity, RFA-DK-11-018, is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant program aimed at pushing forward new technologies that can help make an artificial pancreas more practical and effective for people with Type 1 Diabetes (T1D). The central goal is to support small businesses developing innovative therapeutics and monitoring technologies that move the field toward an integrated, long-term, glucose-regulated insulin delivery system. In other words, NIH is looking to fund early-stage and follow-on R&D that improves the components and performance of closed-loop or near-closed-loop systems that automatically sense glucose levels and adjust insulin delivery accordingly, reducing the daily burden of diabetes management and improving safety and outcomes.
The mechanism used is the SBIR R43/R44 grant pathway, which is the classic two-phase SBIR structure. Phase I (R43) generally supports proof-of-concept work to show the scientific and technical merit of an idea, while Phase II (R44) supports more substantial development to advance the technology toward commercialization and real-world use. Although the source text does not spell out detailed phase budgets, it does provide an overall award ceiling of up to $1,000,000, signaling that the program anticipates funding projects with meaningful development scope rather than purely exploratory studies. The funding instrument is a grant, the opportunity category is discretionary, and the activity focus aligns with NIH’s mission areas captured in the listed CFDA program numbers, including technological innovations to improve human health and extramural research in diabetes and related diseases.
Eligibility is limited strictly to United States small business concerns, and the announcement lays out the standard SBIR definition of an eligible small business. To qualify, the applicant organization must be for-profit, have a place of business in the United States, and primarily operate in the U.S. (or demonstrate a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor). The company must fit an allowable legal structure such as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, with specific limits on foreign participation in joint ventures (no more than 49 percent foreign business entity participation). Ownership and control requirements are also explicit: the business must be at least 51 percent owned and controlled by U.S. citizens or permanent resident aliens, or be majority owned by another qualifying U.S.-owned for-profit business. Finally, the company must have no more than 500 employees including affiliates, which is the standard SBIR size cap.
Key administrative details show that the opportunity was posted on September 20, 2011, with the original closing date of November 23, 2011, later reflected as a current closing date of November 28, 2011, and an archive date of December 29, 2011. There is no cost sharing or matching requirement, which is typical for SBIR awards and important for small companies that may not have large amounts of non-dilutive capital available. The agency is NIH, and the program’s topic area ties to diabetes and biomedical technology innovation, consistent with the involvement of NIH institutes focused on diabetes, digestive and kidney diseases, and broader health technology innovation.
In practical terms, the opportunity is designed to accelerate commercialization-oriented research by small businesses that can contribute enabling pieces of the artificial pancreas ecosystem. While the short description does not list specific technical subtopics, the emphasis on “new therapeutics and monitoring technologies†and an “integrated long term glucose regulated insulin delivery system†points to innovations that could improve glucose sensing, insulin delivery, control algorithms, safety monitoring, biocompatibility, reliability, user experience, and long-duration operation. The overarching expectation is that funded R&D will not just generate academic knowledge, but produce tangible progress toward productizable tools, devices, or systems that can be integrated into an artificial pancreas approach and ultimately improve how T1D is managed.
For applicants or interested parties who need the complete announcement details, NIH provided an additional information link to the full FOA on the NIH grants site. The contact route included in the source data is operational rather than scientific: for trouble accessing or linking to the announcement, applicants are directed to the NIH Office of Extramural Research (OER) Webmaster email address.
Frequently Asked Questions (FAQs) - NIH SBIR RFA-DK-11-018 (Artificial Pancreas Technologies)
What is the funding opportunity RFA-DK-11-018?
RFA-DK-11-018 is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity focused on advancing new technologies that make an artificial pancreas more practical and effective for people with Type 1 Diabetes (T1D). The program supports research and development aimed at improving the components and performance of glucose-regulated insulin delivery systems.
What is the main goal of this SBIR program?
The central goal is to support small businesses developing innovative therapeutics and monitoring technologies that move the field toward an integrated, long-term, glucose-regulated insulin delivery system. The intent is to fund R&D that improves closed-loop or near-closed-loop systems that can sense glucose levels and adjust insulin delivery to improve safety, outcomes, and reduce the day-to-day management burden.
What type of funding mechanism is used?
This opportunity uses the SBIR R43/R44 grant pathway, which follows the classic two-phase SBIR structure: Phase I (R43) and Phase II (R44).
What is Phase I (R43) intended to support?
Phase I (R43) generally supports proof-of-concept work to demonstrate the scientific and technical merit and feasibility of an idea or technology.
What is Phase II (R44) intended to support?
Phase II (R44) generally supports more substantial development work to advance the technology toward commercialization and real-world use.
What is the maximum award amount mentioned for this opportunity?
The source information notes an overall award ceiling of up to $1,000,000.
Is cost sharing or matching required?
No. The opportunity specifies that there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is limited strictly to United States small business concerns that meet standard SBIR eligibility requirements described in the opportunity information.
Does the applicant have to be a for-profit organization?
Yes. The eligible applicant organization must be for-profit.
Does the small business need to be located in the United States?
Yes. The business must have a place of business in the United States and primarily operate in the U.S., or demonstrate a significant contribution to the U.S. economy through taxes or through the use of American products, materials, or labor.
What legal entity types can apply as an SBIR small business under this opportunity?
The opportunity information indicates the business must fit an allowable legal structure such as a sole proprietorship, partnership, limited liability company (LLC), corporation, joint venture, association, trust, or cooperative.
Are joint ventures allowed, and are there limits on foreign participation?
Joint ventures are allowed within the eligible structures mentioned, with a specific limit on foreign participation: no more than 49 percent foreign business entity participation in a joint venture.
What are the ownership and control requirements for the applicant business?
The business must be at least 51 percent owned and controlled by U.S. citizens or permanent resident aliens, or be majority owned by another qualifying U.S.-owned for-profit business.
Is there an employee size limit for eligibility?
Yes. The company must have no more than 500 employees, including affiliates, which matches the standard SBIR size cap.
Which agency is offering this funding opportunity?
The agency is the National Institutes of Health (NIH).
What is the opportunity category and funding instrument?
The opportunity category is discretionary, and the funding instrument is a grant.
What kinds of projects or technologies does NIH want to support with this RFA?
Based on the description provided, NIH is interested in early-stage and follow-on R&D that improves technologies enabling an artificial pancreas approach. The emphasis is on "new therapeutics and monitoring technologies" and progress toward an integrated, long-term, glucose-regulated insulin delivery system. This includes improvements to closed-loop or near-closed-loop performance and integration.
Does the summary list specific technical subtopics or required components?
No. The source text does not list specific technical subtopics, but it emphasizes therapeutics and monitoring technologies that contribute to an integrated, long-term glucose-regulated insulin delivery system.
What is the broader purpose of funding in practical terms?
In practical terms, the program is designed to accelerate commercialization-oriented research by small businesses that can contribute enabling pieces of the artificial pancreas ecosystem. The expectation is tangible progress toward productizable tools, devices, or systems that can be integrated into an artificial pancreas approach.
When was this opportunity posted?
The opportunity was posted on September 20, 2011.
What are the closing date(s) listed for this opportunity?
The source information shows an original closing date of November 23, 2011, and also reflects a current closing date of November 28, 2011.
When was the opportunity archived?
The archive date listed is December 29, 2011.
Where can applicants find the full announcement details?
NIH provided an additional information link to the full Funding Opportunity Announcement (FOA) on the NIH grants site.
Who should be contacted for technical issues accessing or linking to the announcement?
For trouble accessing or linking to the announcement, applicants are directed to contact the NIH Office of Extramural Research (OER) Webmaster via the email address provided in the source data.
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