Opportunity Information: Apply for RFA DK 15 004
Apply for RFA DK 15 004
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Urinary Stone Disease Research Network Clinical Centers (USDRN CCs) (Collaborative 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 24, 2015 and posted on Aug 24, 2015.
- Applicants must submit their applications by Nov 18, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $450,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses State governments Independent school districts Native American tribal governments (Federally recognized) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Urinary Stone Disease Research Network Clinical Centers (USDRN CCs) funding opportunity (RFA-DK-15-004) is a National Institutes of Health (NIH) cooperative agreement (Collaborative U01) intended to build a coordinated, multi-center and multi-disciplinary research network focused on urinary stone disease. The goal is to bring together clinical investigators across sites to run shared protocols, generate high-quality clinical evidence, and produce resources that can be used by the broader research community after the initial studies are completed. Because this is a cooperative agreement, NIH is expected to have substantial scientific and programmatic involvement during the project period, with awardees working in close collaboration under a network structure rather than operating as fully independent investigator-initiated projects.
The network that would be created under this FOA, the Urinary Stone Disease Research Network (USDRN), is tasked with three main scientific and operational deliverables. First, the USDRN must design and conduct a randomized clinical trial that tests whether increasing fluid intake and, importantly, increasing urine output reduces the rate of urinary stone recurrence. This trial is meant to include both adults and children, signaling an intent to generate evidence that can inform prevention strategies across age groups rather than limiting the findings to a single population. Second, the network must conduct clinical research aimed at understanding ureteral stent-related pain and urinary symptoms and developing approaches to lessen those burdens. Stent discomfort is a common real-world problem for patients, so this part of the program emphasizes practical symptom mitigation alongside stone prevention. Third, the USDRN must provide well-curated data and collect biological specimens from these studies so that the resulting datasets and samples can serve as a resource for future researchers, extending the value of the initial NIH investment beyond the original trial and stent-symptom projects.
This announcement specifically supports the Clinical Centers (the sites that enroll and follow participants and carry out the clinical research activities). A companion announcement, RFA-DK-15-005, is referenced as supporting the USDRN Scientific Data Research Center, which would typically be responsible for network-wide data coordination functions such as data management, statistical support, quality control, and centralized study operations. In practical terms, applicants to RFA-DK-15-004 would be proposing to serve as one of the network’s clinical hubs, working under common governance and shared protocols with the other participating sites and the Data/Research Center.
Administratively, the opportunity is categorized as discretionary funding and uses the Cooperative Agreement mechanism. The activity area is listed under health, and the program is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), aligning it with NIH’s kidney and urologic disease research portfolio. The FOA anticipated making two awards, with an estimated total funding amount of about $4,000,000 and an award ceiling of $450,000. The posting date and creation date were August 24, 2015, with an original and current closing date of November 18, 2015, and an archive date of December 19, 2015, indicating this specific round is now historical but still useful as a model for the scope and structure NIH sought for this network.
Eligibility was broad and included many organization types across the public, nonprofit, and private sectors. Eligible applicants included institutions of higher education (public and private), nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses and other for-profits), and various government entities (state, county, city/township, special district, independent school districts, public housing authorities/Indian housing authorities), as well as tribal governments and tribal organizations. The FOA also explicitly noted additional eligible applicants such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, faith-based and community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and even non-U.S. entities (foreign organizations). There was no cost-sharing or matching requirement, which reduces financial barriers to participation and can be especially important for multi-center clinical research proposals that already carry substantial operational costs.
The source announcement link provided by NIH was hosted through the NIH Grants Guide (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-004.html). For access or technical issues, the contact point listed was the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), reflecting that the provided contact information was primarily for announcement access and linking problems rather than scientific or programmatic questions.
Frequently Asked Questions (FAQs): Urinary Stone Disease Research Network Clinical Centers (USDRN CCs) - RFA-DK-15-004
What is the USDRN Clinical Centers funding opportunity (RFA-DK-15-004)?
RFA-DK-15-004 is a National Institutes of Health (NIH) cooperative agreement (Collaborative U01) to establish Clinical Centers for the Urinary Stone Disease Research Network (USDRN). The intent is to build a coordinated, multi-center, and multi-disciplinary network focused on urinary stone disease clinical research using shared protocols and common network governance.
What is the main purpose of creating the USDRN?
The USDRN is intended to bring together clinical investigators across multiple sites to run shared protocols, generate high-quality clinical evidence, and produce data and biological specimen resources that can be used by the broader research community after the initial studies are completed.
What does it mean that this opportunity uses a cooperative agreement (U01) mechanism?
A cooperative agreement means NIH expects to have substantial scientific and programmatic involvement during the project period. Awardees are expected to work closely with NIH and with other network components under a coordinated network structure, rather than operating as fully independent investigator-initiated projects.
What are the required network deliverables described in the opportunity?
The USDRN is tasked with three major deliverables: (1) a randomized clinical trial evaluating whether increased fluid intake and increased urine output reduces urinary stone recurrence; (2) clinical research on ureteral stent-related pain and urinary symptoms, including approaches to lessen these burdens; and (3) well-curated data and biological specimens from these studies to serve as resources for future research.
What clinical trial is the USDRN expected to design and conduct?
The network must design and conduct a randomized clinical trial to test whether increasing fluid intake and, importantly, increasing urine output reduces the rate of urinary stone recurrence.
Does the randomized clinical trial include both adults and children?
Yes. The opportunity states the trial is meant to include both adults and children, reflecting an intent to inform prevention strategies across age groups.
What is the focus of the ureteral stent-related research component?
The network must conduct clinical research aimed at understanding ureteral stent-related pain and urinary symptoms and developing approaches to reduce those symptoms and burdens.
Why does the opportunity emphasize data and specimen resources?
The FOA specifies that data and biological specimens collected through the studies should be well-curated so they can serve as a resource for future researchers, extending the value of the original NIH-supported studies beyond the initial projects.
What types of sites or organizations is RFA-DK-15-004 intended to support?
This announcement specifically supports the USDRN Clinical Centers, meaning the sites that enroll and follow participants and carry out the clinical research activities under shared network protocols.
Is there a separate opportunity for data coordination and centralized study operations?
Yes. A companion announcement, RFA-DK-15-005, is referenced as supporting the USDRN Scientific Data Research Center, which would typically handle network-wide data coordination functions such as data management, statistical support, quality control, and centralized study operations.
How would a Clinical Center interact with the Scientific Data Research Center?
Based on the description provided, Clinical Centers would function as clinical hubs (enrolling and following participants and executing clinical research activities) while working under common governance and shared protocols alongside other sites and the Scientific Data Research Center responsible for network-wide coordination.
How many awards were anticipated under this funding opportunity?
The FOA anticipated making two awards.
What was the estimated total funding amount and award ceiling?
The estimated total funding amount was about $4,000,000, and the award ceiling was $450,000.
What is the program classification and associated CFDA number?
The opportunity is categorized as discretionary funding in the health activity area and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
When was this opportunity posted, and what were the closing and archive dates?
The posting and creation date were August 24, 2015. The original and current closing date listed was November 18, 2015, and the archive date was December 19, 2015.
Is this specific funding round still open?
No. The listed closing date (November 18, 2015) and archive date (December 19, 2015) indicate this specific round is historical.
What types of organizations were eligible to apply?
Eligibility was broad and included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses and other for-profits), and many types of government entities (state, county, city/township, special district, independent school districts, public housing authorities/Indian housing authorities), as well as tribal governments and tribal organizations.
Were any specific institution categories explicitly called out as eligible?
Yes. The FOA explicitly noted additional eligible applicants including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, faith-based and community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and foreign (non-U.S.) entities.
Were foreign organizations eligible to apply?
Yes. The eligibility description explicitly included non-U.S. entities (foreign organizations).
Was cost-sharing or matching required?
No. The FOA stated there was no cost-sharing or matching requirement.
Where was the source announcement posted?
The NIH source announcement was hosted in the NIH Grants Guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-004.html.
Who was listed as the contact for access or technical issues with the announcement?
For access or technical issues, the contact listed was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV. The description indicates this contact was primarily for announcement access and linking problems rather than scientific or programmatic questions.
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