Opportunity Information: Apply for RFA DK 21 001
The NIH funding opportunity "Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed)" (RFA-DK-21-001; CFDA 93.847) is a discretionary grant program focused on accelerating the development of biomarkers that can meaningfully improve how diabetic foot ulcers (DFUs) are studied and managed. The central aim is to move promising DFU biomarker candidates far enough along the pipeline that they are ready for more definitive analytical validation and clinical validation studies, with an emphasis on real-world usability in clinical trials and patient care. Rather than supporting large clinical trials, the announcement is geared toward early-stage but rigorous biomarker work that produces credible, decision-ready candidates.
Scientifically, the program targets three broad biomarker use cases: prognostic biomarkers that help predict outcomes such as healing, infection, recurrence, amputation risk, or time-to-closure; monitoring biomarkers that track disease status and response to therapy over time; and diagnostic biomarkers that aid in identifying clinically relevant states (for example, distinguishing non-healing phenotypes, detecting infection-related processes, or differentiating ulcer types or complications). The intent is not just discovery for its own sake, but development that demonstrates a clear path to application, including evidence that a biomarker can be measured reliably and interpreted consistently enough to support clinical decision-making or trial endpoints.
A defining feature of this opportunity is its use of a phased R61/R33 mechanism. In practical terms, this structure supports a milestone-driven progression, where the initial phase emphasizes feasibility and early validation work (such as assay development, analytical performance, and preliminary clinical associations), and the later phase supports expansion and strengthening of validation evidence once predefined goals are met. This phased approach is designed to encourage innovative ideas while still holding projects to concrete deliverables, reducing the risk that biomarker concepts stall before they become genuinely actionable.
Another major component is the explicit linkage to the Diabetic Foot Consortium. The FOA emphasizes leveraging consortium resources to access well-characterized patient cohorts and high-quality human samples. That matters because DFU biomarker studies often fail when they rely on poorly standardized sample handling, heterogeneous clinical phenotyping, or limited follow-up data. By connecting projects to a consortium infrastructure, the program is aiming to improve reproducibility, ensure higher-quality clinical annotation, and speed up progress by reducing common logistical barriers to obtaining appropriate samples and patient-level data.
Administratively, the opportunity is issued by the National Institutes of Health, uses the grant funding instrument, and falls under the health and nutrition/health activity category. The original closing date listed is 2021-11-03, and the award ceiling shown in the source data is $325,000. The listing indicates expected awards but does not provide a number in the provided text. The "Clinical Trial Not Allowed" designation signals that applicants should propose biomarker development and validation activities that do not meet NIH’s definition of a clinical trial, meaning the work should center on assay/biomarker performance and observational or specimen-based validation rather than prospectively assigning interventions to human participants to evaluate health outcomes.
Eligibility is broad and includes many types of domestic organizations and governmental entities, such as state, county, city/township, and 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; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, non-federally recognized tribal governments, and even non-U.S. entities (foreign organizations). Overall, the program is structured to pull in a wide range of scientific, clinical, and translational expertise while channeling efforts toward a concrete outcome: DFU biomarker candidates that are sufficiently mature to proceed into definitive validation through the Diabetic Foot Consortium.Apply for RFA DK 21 001
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed)" 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 2021-01-13.
- Applicants must submit their applications by 2021-11-03. (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 $325,000.00 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Biomarkers for Diabetic Foot Ulcers through the Diabetic Foot Consortium (R61/R33 Clinical Trial Not Allowed)" and is identified as RFA-DK-21-001 (CFDA 93.847).
What is the overall purpose of this grant program?
This discretionary NIH grant program is designed to accelerate the development of biomarkers for diabetic foot ulcers (DFUs) that can meaningfully improve how DFUs are studied and managed. The focus is on moving promising biomarker candidates far enough along the development pipeline that they are ready for more definitive analytical validation and clinical validation studies, with an emphasis on real-world usability in clinical trials and patient care.
Is this opportunity intended to fund large clinical trials?
No. The opportunity is geared toward early-stage but rigorous biomarker work that produces credible, decision-ready candidates, rather than supporting large clinical trials.
What types of DFU biomarkers does the program support?
The program targets three broad biomarker use cases: (1) prognostic biomarkers, (2) monitoring biomarkers, and (3) diagnostic biomarkers.
What is a prognostic biomarker in the context of this FOA?
Prognostic biomarkers are intended to help predict DFU-related outcomes such as healing, infection, recurrence, amputation risk, or time-to-closure.
What is a monitoring biomarker in the context of this FOA?
Monitoring biomarkers are intended to track disease status and response to therapy over time, helping characterize changes in a DFU or related processes longitudinally.
What is a diagnostic biomarker in the context of this FOA?
Diagnostic biomarkers are intended to aid in identifying clinically relevant states, such as distinguishing non-healing phenotypes, detecting infection-related processes, or differentiating ulcer types or complications.
Does the FOA prioritize discovery research or application-ready development?
The intent is not discovery for its own sake. The FOA emphasizes development that demonstrates a clear path to application, including evidence that the biomarker can be measured reliably and interpreted consistently enough to support clinical decision-making or clinical trial endpoints.
What funding mechanism does this opportunity use?
This FOA uses a phased R61/R33 mechanism.
How does the R61/R33 phased approach work at a high level?
The mechanism supports milestone-driven progression. The initial phase emphasizes feasibility and early validation work, while the later phase supports expansion and strengthening of validation evidence once predefined goals are met.
What kinds of activities are emphasized in the initial (R61) phase?
Based on the description, the R61 phase emphasizes feasibility and early validation activities such as assay development, analytical performance work, and preliminary clinical associations.
What kinds of activities are emphasized in the later (R33) phase?
Based on the description, the R33 phase supports expansion and strengthening of validation evidence after predefined milestones/goals are achieved.
Why does the FOA use a milestone-driven structure?
The phased, milestone-driven structure is intended to encourage innovative ideas while holding projects to concrete deliverables, reducing the risk that biomarker concepts stall before they become actionable.
What is the Diabetic Foot Consortium and why is it important in this FOA?
The FOA explicitly links projects to the Diabetic Foot Consortium and emphasizes leveraging consortium resources to access well-characterized patient cohorts and high-quality human samples. This is intended to improve reproducibility, ensure higher-quality clinical annotation, and reduce logistical barriers to obtaining appropriate samples and patient-level data.
How does consortium access help address common DFU biomarker study problems?
DFU biomarker studies can fail when they rely on poorly standardized sample handling, heterogeneous clinical phenotyping, or limited follow-up data. The consortium linkage is meant to mitigate these issues by enabling higher-quality samples, better standardization, and stronger clinical annotation.
What does "Clinical Trial Not Allowed" mean for applicants?
"Clinical Trial Not Allowed" indicates that applicants should propose biomarker development and validation activities that do not meet NIH's definition of a clinical trial. The work should center on assay/biomarker performance and observational or specimen-based validation rather than prospectively assigning interventions to human participants to evaluate health outcomes.
What kinds of studies are most consistent with this FOA based on the description?
Studies most consistent with this FOA include assay development, analytical performance evaluation, and validation approaches that rely on observational data or existing/specimen-based resources (including high-quality human samples and annotated cohorts available through the consortium), rather than intervention assignment.
Who is the issuing agency for this opportunity?
The opportunity is issued by the National Institutes of Health (NIH).
What is the funding instrument for this opportunity?
The listing specifies that this opportunity uses the grant funding instrument.
What program category does this opportunity fall under?
The opportunity falls under a health and nutrition / health activity category (as described in the provided information).
What is the CFDA number associated with this FOA?
The CFDA number provided is 93.847.
What is the original closing date listed for this opportunity?
The original closing date listed is 2021-11-03.
What is the award ceiling listed in the source data?
The award ceiling shown in the source data is $325,000.
Does the provided information state how many awards are expected?
No. The listing indicates expected awards but does not provide a number in the provided text.
Which types of U.S. government entities are eligible to apply?
Eligibility includes state governments, county governments, city or township governments, special district governments, independent school districts, and federally recognized Native American tribal governments.
Are institutions of higher education eligible?
Yes. Eligibility includes public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible to apply?
Yes. Eligibility includes nonprofit organizations with or without 501(c)(3) status.
Are for-profit organizations eligible to apply?
Yes. Eligibility includes for-profit organizations (other than small businesses), and small businesses are also listed as eligible.
Are housing authorities eligible to apply?
Yes. Public housing authorities and Indian housing authorities are included in the eligibility list.
Are specific minority-serving institutions called out as eligible?
Yes. The FOA highlights additional eligible applicants including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, and TCCUs.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly highlighted as eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible applicants.
Are regional organizations eligible?
Yes. Regional organizations are explicitly highlighted as eligible applicants.
Are non-federally recognized tribal governments eligible?
Yes. Non-federally recognized tribal governments are explicitly highlighted as eligible applicants.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The FOA explicitly notes that non-U.S. entities (foreign organizations) are included among eligible applicants.
What is the central outcome the program is trying to achieve?
The program is channeling efforts toward DFU biomarker candidates that are sufficiently mature and decision-ready to proceed into definitive validation through the Diabetic Foot Consortium.
What does "decision-ready" mean in the context of this opportunity?
Based on the description, "decision-ready" refers to biomarker candidates supported by credible evidence of reliable measurement (assay/analytical performance) and consistent interpretation (meaningful clinical association and usability) such that they are prepared for more definitive analytical validation and clinical validation studies.
What practical considerations does the FOA emphasize for eventual real-world use?
The FOA emphasizes real-world usability in clinical trials and patient care, which implies the biomarker should be measurable reliably and interpreted consistently enough to support clinical decision-making or trial endpoints.
Browse more opportunities from the same category: Food and Nutrition, Health
Next opportunity: High-throughput Discovery and Validation of Novel Signal Transducers or Small Molecules that Modulate Opioid or other Substance Use Disorder Relevant Pathways (R01 - Clinical Trials Not Allowed)
Previous opportunity: Core Infrastructure Support for Cancer Epidemiology Cohorts (U01 Clinical Trial Not Allowed)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA DK 21 001
Applicants also applied for:
Applicants who have applied for this opportunity (RFA DK 21 001) also looked into and applied for these:
| Funding Opportunity |
|---|
| Immune Cell Engineering For Targeted Therapy And Disease Monitoring in Type 1 Diabetes (R01 Clinical Trial Not Allowed) Apply for RFA DK 21 005 Funding Number: RFA DK 21 005 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| New Directions in Hematology Research (SHINE-II) (R01 Clinical Trial Optional) Apply for PAS 21 150 Funding Number: PAS 21 150 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| The Autoantigens and Neoantigens Function in the Etiology and Pathophysiology of Type 1 Diabetes (R01 Clinical Trial Optional) Apply for RFA DK 21 004 Funding Number: RFA DK 21 004 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Program to Advance the Career Development of Scientists from Diverse Backgrounds Conducting Nutrition, Obesity, Diabetes, and Related Research (U24 Clinical Trial Optional) Apply for RFA DK 20 034 Funding Number: RFA DK 20 034 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Nutrition Obesity Research Centers (P30 Clinical Trial Optional) Apply for RFA DK 21 015 Funding Number: RFA DK 21 015 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional) Apply for RFA DK 21 006 Funding Number: RFA DK 21 006 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Kidney Precision Medicine Project Central Hub (U24 Clinical Trial Not Allowed) Apply for RFA DK 20 029 Funding Number: RFA DK 20 029 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Kidney Precision Medicine Project Tissue Interrogation Sites (U01 Clinical Trial Not Allowed) Apply for RFA DK 20 028 Funding Number: RFA DK 20 028 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Kidney Precision Medicine Project Recruitment Sites (U01 Clinical Trial Not Allowed) Apply for RFA DK 20 026 Funding Number: RFA DK 20 026 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Kidney Precision Medicine Project Kidney Tissue Atlas Coordinating Center (U01 Clinical Trial Not Allowed) Apply for RFA DK 20 027 Funding Number: RFA DK 20 027 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Short-Term Research Experience Program to Unlock Potential (STEP-UP) (R25 Clinical Trial Not Allowed) Apply for RFA DK 21 023 Funding Number: RFA DK 21 023 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Support for Small Business Innovation Research (SBIR) to Develop New Technologies for Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R43/R44 Clinical Trial Not Allowed) Apply for RFA DK 21 011 Funding Number: RFA DK 21 011 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Comprehensive Care for Adults with Type 2 Diabetes Mellitus from Populations with Health Disparities (R01 Clinical Trial Optional) Apply for PA 21 232 Funding Number: PA 21 232 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Characterization of Islet-derived Extracellular Vesicles for Improved Detection, Monitoring, Classification, and Treatment of Type 1 Diabetes (R01 Clinical Trial Not Allowed) Apply for RFA DK 21 016 Funding Number: RFA DK 21 016 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Support for 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 (R43/R44 Clinical Trial Not Allowed) Apply for RFA DK 21 021 Funding Number: RFA DK 21 021 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Identification and Characterization of Bioactive Microbial Metabolites for Advancing Research on Microbe-Diet-Host Interactions Knowledgebase Management Center (U24 Clinical Trial Not Allowed) Apply for RFA DK 21 014 Funding Number: RFA DK 21 014 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 002 Funding Number: RFA DK 21 002 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required) Apply for RFA HL 22 014 Funding Number: RFA HL 22 014 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Continuation of The Collaborative Islet Transplantation Registry (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 013 Funding Number: RFA DK 21 013 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Biostatistics Research Center (U01 Clinical Trial Not Allowed) Apply for RFA DK 21 003 Funding Number: RFA DK 21 003 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $25,000,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA DK 21 001", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.