Opportunity Information: Apply for RFA DK 15 024

  • 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 Methods and Technologies for Assessment of Risk and for Early Diagnosis and Prognosis of Type 1 Diabetes (T1D) (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 28, 2015 and posted on Jul 28, 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 $2,000,000.00 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 grant opportunity titled "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 (T1D) (R43/R44)" is a National Institutes of Health (NIH) funding announcement designed specifically for small business concerns that are developing new tools to improve how type 1 diabetes is predicted, detected early, and monitored over time. The core aim is to support research and development that produces innovative technologies or methods that can identify people who are at risk before they develop clinical disease, diagnose type 1 diabetes earlier and more accurately, and provide better prognostic and follow-up information after diagnosis. In practical terms, this is about moving beyond current limitations in screening and monitoring by encouraging small businesses to build next-generation diagnostics, risk assessment platforms, biomarkers, assays, devices, or related enabling technologies that could eventually be used in real-world clinical or research settings.

This funding opportunity uses the SBIR mechanism under the R43/R44 pathways, which generally reflects a phased approach to technology development in small companies. While the announcement summary does not spell out phase-specific caps or durations, the R43/R44 structure typically aligns with early feasibility and proof-of-concept work followed by more advanced development and validation activities that bring a product closer to commercialization. The focus is not simply basic science; it is research leading to development of a technology with clear potential utility for early detection, risk stratification, diagnosis, prognosis, and longitudinal follow-up in type 1 diabetes. That emphasis makes this a particularly relevant opportunity for companies working at the intersection of biomedical engineering, diagnostics, software-enabled health technologies, bioassays, biosensors, clinical decision support, and translational biomarker science, as long as the outcome is a concrete method or technology that advances the state of the art.

The opportunity is issued by the NIH and falls under the program area associated with Diabetes, Digestive, and Kidney Diseases Extramural Research (CFDA 93.847), which is typically associated with NIH efforts to improve prevention, diagnosis, and treatment approaches for diabetes and related conditions. The funding instrument type is a grant, and the opportunity category is discretionary, meaning awards depend on the availability of funds and the merit of applications through the standard review process. The estimated total funding amount listed for the announcement is $2,000,000, indicating NIH expected to support a limited number of projects or a small portfolio of awards within this topic area during the relevant cycle.

Eligibility is limited to small businesses, consistent with SBIR requirements. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined in NIH policy, may be allowed in some circumstances, which can matter for companies that need access to unique cohorts, specialized expertise, or certain technical capabilities not available domestically, provided the arrangement complies with NIH rules. There is no cost sharing or matching requirement, which reduces the financial barrier for early-stage companies and supports the intent of SBIR to stimulate technological innovation and commercialization by small businesses.

Key administrative details reflect that this was a time-limited solicitation. The opportunity number is RFA-DK-15-024. It was posted and created on July 28, 2015, with an original and current closing date of November 18, 2015, and it was archived on December 19, 2015. Even though the announcement is archived, the content still provides a useful template for the kinds of technologies NIH has historically prioritized in this area and can help teams anticipate what future solicitations may look like. For applicants or readers seeking the full text and detailed requirements, the additional information link is provided through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-024.html. For technical issues accessing the announcement, NIH directs users to contact the NIH Office of Extramural Research (OER) webmaster via FBOWebmaster@OD.NIH.GOV.

Overall, the purpose of this SBIR announcement is to push forward practical, testable innovations that improve the ability to assess risk and detect type 1 diabetes earlier, while also strengthening tools that help clinicians and researchers understand disease trajectory and outcomes after diagnosis. The intended result is a stronger pipeline of small-business-driven technologies that can ultimately support earlier intervention, better patient stratification, and improved monitoring, which are all central needs in type 1 diabetes care and research.

Frequently Asked Questions (FAQs)

What is the title of this grant opportunity?

The opportunity is titled "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 (T1D) (R43/R44)."

Who is offering this funding opportunity?

This is a National Institutes of Health (NIH) funding announcement.

What is the main purpose of this SBIR opportunity?

The purpose is to support small businesses developing innovative tools that improve assessment of risk, enable earlier diagnosis, and strengthen prognosis and follow-up for Type 1 Diabetes (T1D). The focus is on practical, testable innovations that can advance beyond current screening and monitoring limitations.

What kinds of outcomes is NIH trying to support with this announcement?

NIH is aiming to support research and development that leads to concrete methods or technologies that can: identify people at risk before clinical disease develops, diagnose T1D earlier and more accurately, and provide better prognostic information and longitudinal follow-up after diagnosis.

Is this opportunity focused on basic science or technology development?

The emphasis is not simply basic science. It is research that leads to development of a technology with clear potential utility for early detection, risk stratification, diagnosis, prognosis, and longitudinal follow-up in T1D.

What types of technologies or approaches appear to fit this funding purpose?

Based on the announcement summary, relevant approaches may include next-generation diagnostics, risk assessment platforms, biomarkers, assays, devices, and enabling technologies intended for real-world clinical or research settings. The summary also suggests relevance for companies working in biomedical engineering, diagnostics, software-enabled health technologies, bioassays, biosensors, clinical decision support, and translational biomarker science, as long as the end result is a concrete method or technology for T1D risk assessment, early diagnosis, prognosis, or follow-up.

What funding mechanism is used (R43/R44)?

This opportunity uses the SBIR mechanism under the R43/R44 pathways, which generally reflect a phased approach to small business technology development (typically moving from early feasibility/proof-of-concept to more advanced development and validation).

Does the summary specify Phase I and Phase II budgets or project durations?

No. The summary provided does not spell out phase-specific caps or durations, even though R43/R44 generally aligns with phased development.

What is the opportunity number?

The opportunity number is RFA-DK-15-024.

What is the funding instrument type and opportunity category?

The funding instrument type is a grant, and the opportunity category is discretionary (awards depend on availability of funds and the merit of applications through the standard review process).

What program area or CFDA number is associated with this opportunity?

The announcement is associated with Diabetes, Digestive, and Kidney Diseases Extramural Research and lists CFDA 93.847.

How much total funding was estimated for this announcement?

The estimated total funding amount listed is $2,000,000, suggesting NIH expected to support a limited number of projects or a small portfolio of awards within this topic area during the relevant cycle.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR requirements.

Are non-U.S. (foreign) entities eligible to apply?

No. Foreign (non-U.S.) entities are not eligible to apply.

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

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

Can a U.S. small business include any foreign component at all?

The summary notes that foreign components, as defined in NIH policy, may be allowed in some circumstances. This can be relevant when a company needs access to unique cohorts, specialized expertise, or technical capabilities not available domestically, provided the arrangement complies with NIH rules.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement.

When was this opportunity posted and when did it close?

It was posted and created on July 28, 2015, and the closing date (original and current) was November 18, 2015.

Is this opportunity still active?

No. It is archived. The archive date listed is December 19, 2015.

If it is archived, why might it still be useful?

Even though it is archived, the content can still serve as a template for the types of T1D risk assessment and early diagnosis technologies NIH has historically prioritized, and it may help teams anticipate what future solicitations could look like.

Where can I find the full announcement text and detailed requirements?

The additional information link provided is: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-024.html

Who should be contacted for technical issues accessing the announcement?

For technical issues, NIH directs users to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

What is the intended real-world impact of technologies funded through this topic?

The stated intent is to strengthen the pipeline of small-business-driven technologies that support earlier intervention, better patient stratification, and improved monitoring in Type 1 Diabetes care and research by improving risk assessment, early detection, and prognosis/longitudinal follow-up tools.

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