Opportunity Information: Apply for RFA DK 21 505
The National Institutes of Health (NIH) released this discretionary funding opportunity, RFA-DK-21-505, titled "Limited Competition for the Continuation of the Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Optional)." It uses the cooperative agreement mechanism (U24), which means the awardee is expected to work closely with NIH staff and consortium partners rather than operating entirely independently. The overall purpose is to fund a Data Coordinating Center (DCC) that will provide centralized coordination and technical leadership for the Diabetic Foot Consortium (DFC), a clinical research program focused on diabetic foot ulcers, including studies that may range from observational and biomarker validation work to future clinical trials.
The scientific and programmatic focus is diabetic foot ulcer research, with an early emphasis on validating biomarkers that can predict whether a wound will heal or how it will respond to therapy. The consortium also plans to study biomarkers and related measures that help assess the risk of infection and the likelihood of ulcer recurrence, both of which are major drivers of complications such as hospitalization and amputation. Beyond the initial biomarker validation studies, the announcement signals a longer-term pipeline that may include clinical trials and additional studies aimed at better understanding the underlying pathophysiology of diabetic foot ulcers. In practice, this means the DCC needs to be ready to support multiple study designs over time, potentially including trials where interventions are tested and outcomes are monitored in a standardized way across multiple clinical sites.
A key requirement is relevant, demonstrated experience. Because diabetic wound healing studies are clinically complex (variability in patient comorbidities, ulcer severity and classification, infection assessment, offloading and wound care practices, imaging and lab measures, and longitudinal outcome definitions), the FOA specifies that applicants must have prior experience serving as a data coordinating center for clinical studies of diabetic foot ulcers. This is not framed as a general clinical DCC; it is narrowly tailored to an entity that already understands the operational realities, data standards, and quality challenges specific to diabetic foot ulcer research.
The DCCs responsibilities are broad and central to making the consortium function. The awardee is expected to provide overall project coordination and administration, which typically includes organizing governance activities, supporting consortium meetings, maintaining documentation, and ensuring that study milestones and timelines are tracked and met. The DCC is also responsible for quality control, which generally covers protocol compliance monitoring, data verification, training and support for site staff, and establishing consistent procedures across participating sites so that data are comparable and reliable. Data management is another core function, encompassing database development and maintenance, data capture workflows, data cleaning, and secure handling of sensitive clinical information. Finally, the DCC must deliver biostatistical support, which commonly includes contributing to study design, randomization plans when trials are involved, statistical analysis plans, interim and final analyses, and reporting that meets NIH expectations and scientific publication standards.
Eligibility details in the summary indicate that foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. At the same time, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S.-based applicant could potentially include certain foreign elements in the project if they meet NIH definitions and requirements, but the primary applicant organization itself must be eligible under NIH rules. The opportunity listing also notes eligible applicants include small businesses, though the full announcement would typically spell out all eligible organizational types and any additional constraints tied to the "limited competition" designation (which often indicates the competition is restricted to certain prior awardees or a defined group, depending on NIH program intent).
From a funding perspective, the award ceiling shown is $2,240,000, and the original closing date for applications was August 18, 2022. The activity is categorized under health and food and nutrition, with CFDA number 93.847, reflecting its placement within NIHs portfolio and the Institute-focused domain implied by the FOA number. Overall, the opportunity is essentially seeking an experienced coordinating hub that can run the operational backbone of the Diabetic Foot Consortium, ensuring that complex multi-site diabetic foot ulcer studies generate high-quality, analyzable data and that the consortium can efficiently move from biomarker validation into future mechanistic studies and clinical trials as the research program evolves.Apply for RFA DK 21 505
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Data Coordinating Center for the Diabetic Foot Consortium (U24 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 2022-03-03.
- Applicants must submit their applications by 2022-08-18. (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 $2,240,000.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is NIH RFA-DK-21-505, titled "Limited Competition for the Continuation of the Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Optional)."
Which federal agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
What is being funded under this opportunity?
This funding supports a Data Coordinating Center (DCC) that will provide centralized coordination and technical leadership for the Diabetic Foot Consortium (DFC), a clinical research program focused on diabetic foot ulcers.
What does "Data Coordinating Center (DCC)" mean in this context?
In this program, the DCC is the operational hub for the consortium. It is responsible for coordinating studies across sites, ensuring consistent data collection and quality, managing databases and secure data workflows, and providing biostatistical support for study design and analysis.
What is the Diabetic Foot Consortium (DFC)?
The DFC is a clinical research program focused on diabetic foot ulcers. The consortium is expected to conduct studies that may range from observational work and biomarker validation to future clinical trials and additional studies on underlying disease mechanisms.
What is the main scientific focus of the consortium described in the opportunity?
The focus is diabetic foot ulcer research. Early emphasis is on validating biomarkers that can predict wound healing and response to therapy, as well as biomarkers and related measures for infection risk and ulcer recurrence.
What types of studies might the DCC need to support?
The announcement indicates the DCC should be prepared to support multiple study designs over time, including observational studies, biomarker validation studies, and potentially clinical trials where interventions are tested across multiple clinical sites with standardized outcome monitoring.
What does "U24" mean for applicants and awardees?
U24 is a cooperative agreement mechanism. This means the awardee is expected to work closely with NIH staff and consortium partners rather than operating entirely independently.
What does "Clinical Trial Optional" imply here?
It indicates the program may include clinical trials in the longer-term pipeline, and the DCC should be ready to support trials if they occur. The DCC should also be capable of supporting non-trial study designs (for example, observational or biomarker validation studies).
Why is this described as a "limited competition" opportunity?
The opportunity is labeled "limited competition," which typically means the competition is restricted to a defined group (often tied to program intent or prior award structures). The summary does not specify the exact restriction details beyond that designation.
What prior experience is required to apply?
The FOA specifies applicants must have prior experience serving as a data coordinating center for clinical studies of diabetic foot ulcers. This is presented as a specific, demonstrated requirement due to the complexity of diabetic wound healing research.
Is general clinical trial coordinating center experience enough?
Based on the summary provided, the requirement is not framed as general DCC experience. It is narrowly tailored to entities with prior DCC experience specifically in clinical studies of diabetic foot ulcers.
Why does the program require diabetic foot ulcer-specific DCC experience?
The summary explains that diabetic wound healing studies are clinically complex, involving variability in patient comorbidities, ulcer severity and classification, infection assessment, offloading and wound care practices, imaging and lab measures, and longitudinal outcome definitions. The DCC needs to understand these operational and data-quality realities.
What are the core responsibilities of the DCC?
The DCC responsibilities described include: overall project coordination and administration; organizing governance activities; supporting consortium meetings; maintaining documentation; tracking milestones and timelines; quality control and protocol compliance monitoring; data verification; training and support for site staff; establishing consistent cross-site procedures; data management (database development/maintenance, data capture workflows, data cleaning, secure handling of sensitive clinical data); and biostatistical support (study design input, randomization plans when applicable, statistical analysis plans, interim/final analyses, and reporting suitable for NIH expectations and publications).
What does "quality control" cover for this DCC?
Quality control is described as including protocol compliance monitoring, data verification, training and support for site staff, and establishing consistent procedures across participating sites so the resulting data are comparable and reliable.
What does "data management" include for this award?
Data management responsibilities include database development and maintenance, data capture workflows, data cleaning, and secure handling of sensitive clinical information.
What biostatistics support is expected from the DCC?
Biostatistical responsibilities include contributing to study design, developing randomization plans when trials are involved, creating statistical analysis plans, conducting interim and final analyses, and supporting reporting aligned with NIH expectations and scientific publication standards.
What kinds of outcomes or clinical issues are emphasized in the research program?
Early studies emphasize biomarkers predicting wound healing and therapy response. The program also highlights biomarkers and related measures tied to infection risk and ulcer recurrence, which are described as major drivers of complications including hospitalization and amputation.
Are foreign institutions eligible to apply?
No. The summary states foreign institutions are not eligible to apply.
Can a U.S. organization with non-U.S. components apply?
No. The summary states non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign elements allowed at all?
Yes. The summary notes that "foreign components," as defined in the NIH Grants Policy Statement, are allowed. This suggests a U.S.-based applicant may be able to include certain foreign elements if they meet NIH definitions and requirements, while still complying with the stated eligibility limits on foreign institutions and non-U.S. components.
Are small businesses eligible to apply?
Yes. The summary indicates eligible applicants include small businesses.
What is the maximum funding amount listed for this opportunity?
The award ceiling shown is $2,240,000.
What was the application due date listed in the summary?
The original closing date for applications was August 18, 2022.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.847.
How is this opportunity categorized?
The activity is categorized under health and food and nutrition.
What is the overall goal of funding the DCC for the DFC?
The goal is to support an experienced coordinating hub that runs the operational backbone of the Diabetic Foot Consortium, enabling complex multi-site diabetic foot ulcer studies to generate high-quality, analyzable data and helping the program move from biomarker validation into future mechanistic studies and clinical trials as the research evolves.
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