Opportunity Information: Apply for RFA DK 13 506

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Chronic Kidney Disease (CKD) Biomarkers Consortium Data Coordinating Center (U01)" 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 Aug 2, 2013 and posted on Aug 2, 2013.
  • Applicants must submit their applications by Nov 27, 2013. (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: Others (see text field entitled Additional Information on Eligibility for clarification).
  • Other Eligible Applicants include the following Only the currently participating awardees are eligible to apply for this FOA. 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, are not allowed.
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Opportunity Summary:

This funding opportunity (RFA DK 13 506) is a limited-competition NIH cooperative agreement (U01) to establish a dedicated Data Coordinating Center (DCC) for the Chronic Kidney Disease Biomarkers Consortium (CKD BioCon). CKD BioCon was originally launched in September 2009 under RFA DK 08 015 with the goal of developing, validating, and qualifying chronic kidney disease biomarkers using existing biospecimens from well-characterized CKD patient cohorts that have longitudinal follow-up data. The consortium is made up of six Participating Centers and is already running multiple research protocols, meaning it has ongoing, multi-site scientific work that depends heavily on consistent data practices and strong cross-site coordination.

The core reason for this announcement is that the original consortium funding did not include a formal DCC, even though the consortium’s scope has proven complex. In the absence of a DCC, the consortium relied on a study coordination group put in place via a subcontract to one of the Participating Centers, mainly to handle logistics and organize consortium meetings. That stopgap approach helped with basic coordination, but the announcement emphasizes that it does not fully cover the level of specialized expertise required for a mature, multicenter biomarker consortium, particularly in two areas: (1) coordinating multi-center studies in a structured, standardized way, and (2) performing advanced statistical analyses needed to support biomarker discovery and validation efforts across multiple protocols and sites. In practical terms, this FOA is NIH’s mechanism to professionalize and centralize the consortium’s data operations and analytic backbone so the scientific work can be integrated, comparable across centers, and statistically rigorous.

Administratively, this is a discretionary funding opportunity from the National Institutes of Health, in the activity area tied to Diabetes, Digestive, and Kidney Diseases (CFDA 93.847). It uses the cooperative agreement mechanism, which typically means NIH expects substantial programmatic involvement, shared decision-making, and active collaboration between award recipients and NIH staff compared with a standard research project grant. The estimated total funding listed is $2,000,000 for the opportunity, and there is no cost-sharing or matching requirement.

Eligibility is intentionally narrow. Only the currently participating awardees in the CKD BioCon consortium are eligible to apply, making this a closed, limited competition intended to support the existing network rather than expand it. Non-U.S. entities are not eligible, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. The opportunity was posted and created on August 2, 2013, with an original and current closing date of November 27, 2013, and an archive date of December 28, 2013.

Overall, the opportunity is best understood as infrastructure funding to strengthen the consortium’s ability to function as a coordinated, multi-site biomarker engine. By creating a formal DCC, NIH is aiming to fill gaps that commonly arise in multi-center translational research: harmonizing data collection and management practices, ensuring consistent protocol execution and reporting across sites, supporting sophisticated statistical methods for biomarker validation, and improving governance and coordination so that findings derived from shared biosamples and longitudinal clinical data can be trusted, compared, and ultimately moved toward qualification and broader use. For full details, NIH directs applicants to the full announcement at http://grants.nih.gov/grants/guide/rfa files/RFA DK 13 506.html and provides NIH OER webmaster contacts for access or linking issues.

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity (RFA DK 13 506) is an NIH limited-competition cooperative agreement (U01) to establish a dedicated Data Coordinating Center (DCC) for the Chronic Kidney Disease Biomarkers Consortium (CKD BioCon).

What is CKD BioCon?

The Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) is a multi-center consortium originally launched in September 2009 (under RFA DK 08 015) to develop, validate, and qualify chronic kidney disease biomarkers using existing biospecimens from well-characterized CKD patient cohorts with longitudinal follow-up data.

Why is NIH creating a dedicated Data Coordinating Center (DCC) now?

The original consortium funding did not include a formal DCC, even though the consortium has proven complex and is running multiple ongoing, multi-site research protocols. NIH is using this announcement to centralize and professionalize the consortium's data operations and analytics so work across centers and protocols can be integrated, comparable, and statistically rigorous.

What coordination approach was used before this DCC opportunity?

In the absence of a DCC, the consortium relied on a study coordination group established via a subcontract to one of the Participating Centers. That group primarily handled logistics and organized consortium meetings, but it was described as a stopgap that did not fully cover the specialized expertise needed for a mature multicenter biomarker consortium.

What gaps is the DCC expected to address?

Based on the announcement, the DCC is intended to address two major needs: (1) coordinating multi-center studies in a structured, standardized way, and (2) performing advanced statistical analyses to support biomarker discovery and validation across multiple protocols and sites.

Is this funding primarily for new research studies or for infrastructure?

This opportunity is best understood as infrastructure funding for the consortium's coordinating and analytic backbone. The emphasis is on harmonizing and managing data and improving cross-site coordination and statistical rigor for the consortium's ongoing multi-site scientific work.

What makes this a "cooperative agreement" (U01) rather than a standard grant?

The opportunity uses the NIH cooperative agreement mechanism (U01), which generally indicates substantial NIH programmatic involvement and active collaboration between the award recipient(s) and NIH staff, with shared decision-making compared with a standard research project grant.

Which NIH area is associated with this opportunity?

Administratively, it is listed under the activity area tied to Diabetes, Digestive, and Kidney Diseases, with CFDA 93.847.

How much funding is available?

The estimated total funding listed for the opportunity is $2,000,000.

Is cost sharing or matching required?

No. The announcement states there is no cost-sharing or matching requirement.

Who is eligible to apply?

Eligibility is intentionally narrow. Only the currently participating awardees in the CKD BioCon consortium are eligible to apply. This is a closed, limited competition intended to support the existing network rather than expand it.

Are non-U.S. entities eligible?

No. Non-U.S. entities are not eligible.

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

No. The announcement indicates that non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy?

No. Foreign components (as defined by NIH policy) are not allowed under this opportunity.

How many centers make up the CKD BioCon consortium?

The consortium is made up of six Participating Centers.

Is the consortium already conducting studies that would depend on the DCC?

Yes. The consortium is described as already running multiple research protocols, with ongoing multi-site scientific work that depends heavily on consistent data practices and strong cross-site coordination.

What kinds of improvements does NIH expect a DCC to enable for the consortium?

The announcement describes expectations such as harmonizing data collection and management practices, ensuring consistent protocol execution and reporting across sites, supporting sophisticated statistical methods for biomarker validation, and improving governance and coordination so findings from shared biosamples and longitudinal clinical data can be trusted and compared.

When was this opportunity posted?

The opportunity was posted and created on August 2, 2013.

What was the application due date?

The original and current closing date listed is November 27, 2013.

When was this opportunity archived?

The archive date listed is December 28, 2013.

Where can applicants find the full announcement?

NIH directs applicants to the full announcement at: http://grants.nih.gov/grants/guide/rfa files/RFA DK 13 506.html

Who should be contacted for access or linking issues to the announcement?

The information provided indicates NIH OER webmaster contacts are available for access or linking issues related to the full announcement.

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