Opportunity Information: Apply for RFA DK 21 006
This grant opportunity, titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)," is a National Institutes of Health (NIH) discretionary funding announcement (Funding Opportunity Number: RFA-DK-21-006) that supports original research aimed at overcoming key scientific and engineering barriers that slow progress toward effective cell replacement treatments for type 1 diabetes. The central focus is on advancing the technologies that make cell replacement more viable in real-world clinical settings, especially by developing and testing new biomaterials, devices, and other supportive bioengineering approaches that can improve the survival, function, delivery, and long-term performance of replacement insulin-producing cells.
The research scope is geared toward practical bottlenecks in the field of T1D cell therapy, where promising cell sources and transplantation concepts often run into problems like poor engraftment, limited oxygen and nutrient diffusion, immune rejection, inflammatory responses to implanted materials, inadequate vascularization, device failure, or challenges with scaling and consistent manufacturing. Projects under this FOA are expected to generate technology-driven solutions that directly strengthen cell replacement interventions. That could include next-generation encapsulation materials, implantable devices, scaffolds, coatings, or other platforms designed to protect therapeutic cells while still allowing glucose sensing and insulin release, as well as approaches that improve integration with host tissue and maintain stable cell function over time. The "Clinical Trial Optional" designation means applicants may propose either preclinical work or clinical research, including clinical trials, when appropriate for the stage of development and the evidence supporting readiness.
The funding mechanism is an R01 research project grant, which typically supports hypothesis-driven, multi-year research programs with clear aims, solid preliminary rationale, and a defined path toward measurable outcomes. The award ceiling listed for this opportunity is $500,000, indicating an upper limit on allowable costs per year (as provided in the source summary). While the number of expected awards is not specified in the provided data, the program is clearly positioned to fund a set of projects that push beyond incremental improvements and instead create enabling technologies that can change what is feasible for T1D cell replacement therapies.
Eligibility is broad and designed to attract applicants from many parts of the research and innovation ecosystem. Eligible applicants include state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education, per the listing); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations. That wide eligibility reflects an intent to draw strong ideas from bioengineering, materials science, immunology, transplantation, endocrinology, and medical device development, including interdisciplinary teams that combine academic research with translational and product-development capabilities.
From an administrative standpoint, the opportunity sits within the NIH portfolio and is categorized under "Food and Nutrition, Health," with CFDA number 93.847. The original closing date listed is October 20, 2021, and the record creation date is April 6, 2021. In plain terms, this FOA was aimed at accelerating the technology side of T1D cell replacement: not simply studying the disease, but building and validating the materials and device-level solutions that can make implanted or transplanted insulin-producing cells safer, longer-lasting, and more effective for patients.Apply for RFA DK 21 006
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)" 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 2021-04-06.
- Applicants must submit their applications by 2021-10-20. (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 $500,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DK-21-006.
Which federal agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) discretionary funding announcement.
What is the purpose of this FOA?
The FOA supports original research aimed at overcoming key scientific and engineering barriers that slow progress toward effective cell replacement therapies for type 1 diabetes. The emphasis is on advancing enabling technologies that make cell replacement more viable in real-world clinical settings.
What kinds of research are prioritized under this opportunity?
Projects are expected to develop and test technology-driven solutions that improve the survival, function, delivery, and long-term performance of replacement insulin-producing cells. The scope is geared toward practical bottlenecks that limit translation of cell replacement approaches.
Is this grant focused on studying type 1 diabetes biology, or on building technologies?
Based on the description provided, the focus is on the technology and bioengineering side of type 1 diabetes cell replacement (for example, biomaterials and devices), rather than simply studying the disease.
What specific barriers in T1D cell replacement therapies does the FOA aim to address?
The FOA highlights barriers such as poor engraftment, limited oxygen and nutrient diffusion, immune rejection, inflammatory responses to implanted materials, inadequate vascularization, device failure, and challenges with scaling and consistent manufacturing.
What types of solutions or platforms could be responsive to this FOA?
Examples mentioned include next-generation encapsulation materials, implantable devices, scaffolds, coatings, and other platforms designed to protect therapeutic cells while still allowing glucose sensing and insulin release, as well as approaches that improve integration with host tissue and maintain stable cell function over time.
Does this opportunity support work on biomaterials and medical devices?
Yes. The description specifically calls out developing and testing new biomaterials, devices, and supportive bioengineering approaches to improve cell replacement outcomes.
What is meant by "Clinical Trial Optional"?
"Clinical Trial Optional" means applicants may propose either preclinical work or clinical research, including clinical trials, when appropriate for the stage of development and the evidence supporting readiness.
Are clinical trials required?
No. The designation provided is "Clinical Trial Optional," which indicates clinical trials may be proposed but are not required.
What funding mechanism is used for this opportunity?
The funding mechanism is an R01 research project grant.
What type of projects are typically supported by an R01?
As described in the opportunity summary, an R01 typically supports hypothesis-driven, multi-year research programs with clear aims, solid preliminary rationale, and a defined path toward measurable outcomes.
What is the award ceiling for this FOA?
The award ceiling listed is $500,000, described as an upper limit on allowable costs per year (as provided in the source summary).
How many awards does NIH expect to make under this FOA?
The number of expected awards is not specified in the information provided.
What topic area or category is this opportunity listed under?
The opportunity is categorized under "Food and Nutrition, Health."
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.847.
Who is eligible to apply for this grant?
Eligibility is broad. Eligible applicants include state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education, per the listing); for-profit organizations other than small businesses; and small businesses.
Are small businesses eligible to apply?
Yes, small businesses are listed as eligible applicants.
Are for-profit organizations eligible to apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it also explicitly includes small businesses as eligible applicants.
Are nonprofit organizations eligible to apply?
Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible (as long as they are not institutions of higher education, per the listing provided).
Are universities and colleges eligible to apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are tribal entities eligible to apply?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized are also listed as eligible.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA explicitly highlights U.S. territories or possessions as eligible applicant categories.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. (foreign) organizations are explicitly listed among the eligible applicant categories.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly highlighted among eligible applicant categories.
Are minority-serving institutions specifically encouraged or included in eligibility?
The FOA highlights several categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs) as eligible applicant categories.
Is this opportunity intended to encourage interdisciplinary teams?
Yes. The summary indicates the broad eligibility is intended to draw strong ideas from areas such as bioengineering, materials science, immunology, transplantation, endocrinology, and medical device development, including interdisciplinary teams that combine academic research with translational and product-development capabilities.
What is the closing date for this funding opportunity?
The original closing date listed is October 20, 2021.
When was the record for this opportunity created?
The record creation date is April 6, 2021.
What is the main practical goal of projects funded under this FOA?
The stated intent is to create and validate enabling technologies that make implanted or transplanted insulin-producing cells safer, longer-lasting, and more effective for patients by improving performance in real-world clinical settings.
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