Opportunity Information: Apply for RFA DK 16 004
Apply for RFA DK 16 004
- The HHS-NIH11 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 (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,.
- This funding opportunity was created on Nov 19, 2015 and posted on Nov 19, 2015.
- Applicants must submit their applications by Jun 28, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The grant opportunity titled "Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/R44)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) solicitation aimed at accelerating practical, technology-driven advances that could make cell replacement therapies for type 1 diabetes (T1D) more effective. The core purpose is to support research and development efforts by small businesses that are working on innovative tools, platforms, or engineered solutions that address key bottlenecks in replacing or restoring insulin-producing cells, with the ultimate goal of improving therapeutic outcomes for people living with T1D.
This opportunity is issued as a discretionary grant under the NIH SBIR mechanism using the R43/R44 activity codes, which generally correspond to the SBIR Phase I (R43) and Phase II (R44) pathway. In plain terms, it is structured to help small companies move from early feasibility work into more advanced development steps, where a technology can be refined, validated, and pushed closer to real-world use. While the specific dollar ceiling and number of expected awards are not listed in the provided data, the framing is clearly oriented toward product-relevant development rather than basic exploratory science, meaning applicants would typically be expected to propose milestones, measurable performance targets, and a development plan that supports eventual translation.
The scientific and technical focus centers on "new technologies and bioengineering solutions" that can move the field of cell replacement therapy forward. In the context of T1D, cell replacement therapy usually refers to approaches that replenish functional insulin-producing beta cells, such as transplantation of pancreatic islets, implantation of stem cell-derived beta-like cells, or engineered cell systems designed to sense glucose and secrete insulin. Historically, major obstacles have included immune rejection and autoimmunity, the need for immunosuppression, limited cell sources, poor cell survival after implantation, inadequate oxygen and nutrient supply, fibrosis around implants, challenges with vascularization, and maintaining stable, long-term glucose-responsive insulin secretion. The FOA is essentially inviting small businesses to propose technologies that tackle these kinds of real, engineering-heavy challenges, for example through advanced biomaterials, encapsulation or immune-protective devices, cell manufacturing and maturation platforms, monitoring and control systems, or other enabling technologies that improve engraftment, survival, function, and safety.
Eligibility is limited to small businesses, consistent with the SBIR program requirements. The sponsoring agency is the U.S. Department of Health and Human Services, specifically the NIH (listed as HHS-NIH11 in the source data). The opportunity is cataloged under CFDA numbers 93.847 and is classified under the broad funding activity categories of Health and Food and Nutrition, reflecting its relevance to diabetes and metabolic health. The Funding Opportunity Announcement number is RFA DK 16 004, indicating it is associated with NIH's diabetes and kidney-related institute portfolio (commonly the National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK, though the provided record does not explicitly spell that out).
From an administrative timeline standpoint, the FOA was created and posted on November 19, 2015, and the closing date for applications was June 28, 2016 (both the original and current closing dates match, suggesting no deadline extension in the provided record). Overall, the opportunity is best understood as a targeted SBIR call designed to harness small business innovation to solve the practical bioengineering and translational hurdles that stand between promising beta cell replacement concepts and widely usable, durable therapies for type 1 diabetes.
FAQs: Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/R44)
What is the 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 (R43/R44)."
What is the overall goal of this funding opportunity?
The goal is to accelerate practical, technology-driven advances that could make cell replacement therapies for type 1 diabetes (T1D) more effective. It supports small businesses developing innovative tools, platforms, or engineered solutions that address key bottlenecks in replacing or restoring insulin-producing cells, with the long-term aim of improving outcomes for people living with T1D.
Who is the sponsoring agency?
The sponsoring agency is the U.S. Department of Health and Human Services (HHS), specifically the National Institutes of Health (NIH) (listed as HHS-NIH11 in the source data).
What type of grant mechanism is this?
This is an NIH Small Business Innovation Research (SBIR) solicitation issued as a discretionary grant using the R43/R44 activity codes, which generally correspond to SBIR Phase I (R43) and Phase II (R44).
What do R43 and R44 mean in practical terms?
R43 (SBIR Phase I) generally supports early feasibility work, and R44 (SBIR Phase II) generally supports more advanced development. The structure is meant to help small companies move from initial feasibility to refining, validating, and pushing a technology closer to real-world use.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR program requirements.
What scientific area does this opportunity focus on?
The focus is on new technologies and bioengineering solutions that advance cell replacement therapy for type 1 diabetes, especially technologies that address practical and translational challenges that limit durable, widely usable therapies.
What is meant by "cell replacement therapy" in the context of type 1 diabetes?
In this context, cell replacement therapy generally refers to approaches that replenish functional insulin-producing beta cells. Examples described include transplantation of pancreatic islets, implantation of stem cell-derived beta-like cells, and engineered cell systems designed to sense glucose and secrete insulin.
What kinds of problems or bottlenecks is the FOA trying to solve?
The FOA is aimed at overcoming key obstacles that have historically limited cell replacement therapies, including immune rejection and autoimmunity, the need for immunosuppression, limited cell sources, poor cell survival after implantation, inadequate oxygen and nutrient supply, fibrosis around implants, challenges with vascularization, and maintaining stable, long-term glucose-responsive insulin secretion.
What kinds of projects does the FOA appear to be encouraging?
Based on the description, the FOA invites small businesses to propose engineering-forward, product-relevant technologies that tackle the hurdles of engraftment, survival, function, and safety in beta cell replacement. Examples mentioned include advanced biomaterials, encapsulation or immune-protective devices, cell manufacturing and maturation platforms, and monitoring and control systems, as well as other enabling technologies.
Is this opportunity more focused on basic science or product-relevant development?
The framing is oriented toward product-relevant development rather than basic exploratory science. Applicants would typically be expected to propose milestones, measurable performance targets, and a development plan that supports eventual translation.
Are award amounts or a funding ceiling provided in the information available here?
No. The provided information does not list a specific dollar ceiling or the expected number of awards.
What is the Funding Opportunity Announcement (FOA) number?
The FOA number is RFA DK 16 004.
What CFDA number(s) are associated with this opportunity?
The opportunity is cataloged under CFDA number 93.847 in the provided data.
How is this opportunity categorized in terms of funding activity?
It is classified under the broad funding activity categories of Health and Food and Nutrition, reflecting its relevance to diabetes and metabolic health.
When was this FOA posted?
The FOA was created and posted on November 19, 2015.
What was the application closing date?
The closing date for applications was June 28, 2016. The original and current closing dates match in the provided record, suggesting no deadline extension in the data shown.
What is the intended impact of funded work?
The intended impact is to help advance technologies that make beta cell replacement concepts more durable and usable in real-world settings by improving engraftment, long-term survival, functional glucose-responsive insulin secretion, and overall safety for people with T1D.
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Applicants who have applied for this opportunity (RFA DK 16 004) also looked into and applied for these:
| Funding Opportunity |
|---|
| Psychosocial and Behavioral Mechanisms in Bariatric Surgery (R01) Apply for RFA DK 16 017 Funding Number: RFA DK 16 017 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) Apply for PAR 16 064 Funding Number: PAR 16 064 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $125,000 |
| Limited Competition for the Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium (U24) Apply for RFA DK 16 507 Funding Number: RFA DK 16 507 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $1,000,000 |
| Clinical Centers to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium (U01) Apply for RFA DK 16 010 Funding Number: RFA DK 16 010 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $250,000 |
| Silvio O. Conte Digestive Diseases Research Core Centers (P30) Apply for RFA DK 16 019 Funding Number: RFA DK 16 019 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $750,000 |
| NIDDK Program Projects (P01) Apply for PAR 16 127 Funding Number: PAR 16 127 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $6,250,000 |
| High Impact, Interdisciplinary Science in NIDDK Research Areas (RC2) Apply for PAR 16 126 Funding Number: PAR 16 126 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01) Apply for PAR 16 121 Funding Number: PAR 16 121 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition: Small Grant Program for NIDDK K01/K08/K23 Recipients (R03) Apply for PAR 16 148 Funding Number: PAR 16 148 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $50,000 |
| Advances in Polycystic Kidney Disease (R01) Apply for PA 16 159 Funding Number: PA 16 159 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Human Islet Distribution Coordinating Center (UC4) Apply for RFA DK 16 023 Funding Number: RFA DK 16 023 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $1,300,000 |
| Limited Competition: Rare Diseases Clinical Research Network (RDCRN) Project Supplements for Clinical Trials to Repurpose Drugs in Collaboration with E-Rare Awardees (Admin Supp) Apply for PA 16 183 Funding Number: PA 16 183 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Short-Term Research Experience Program for Underrepresented Persons (STEP-UP) (R25) Apply for RFA DK 16 021 Funding Number: RFA DK 16 021 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 16 211 Funding Number: PAR 16 211 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Nutrition Obesity Research Centers (NORCs) (P30) Apply for RFA DK 16 006 Funding Number: RFA DK 16 006 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Standardization of C-peptide and HbA1c Measurements Program (UC4) Apply for RFA DK 16 011 Funding Number: RFA DK 16 011 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $350,000 |
| Diabetes Research Centers (P30) Apply for RFA DK 16 020 Funding Number: RFA DK 16 020 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Ancillary Studies to Identify Behavioral and/or Psychological Phenotypes Contributing to Obesity (R01) Apply for PAR 16 304 Funding Number: PAR 16 304 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Collaborative Islet Transplantation Registry (UC4) Apply for RFA DK 16 503 Funding Number: RFA DK 16 503 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Neurocognitive Effects of Glycemic Dysregulation in Type 1 Diabetes (DP3) Apply for RFA DK 16 007 Funding Number: RFA DK 16 007 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: $3,000,000 |
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