Opportunity Information: Apply for RFA DK 13 508
Apply for RFA DK 13 508
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition for the Data Coordinating Center for Type I Diabetes TrialNet (UC4)" 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 Nov 7, 2013 and posted on Nov 7, 2013.
- Applicants must submit their applications by Feb 19, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $25,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following 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 grant opportunity, titled "Limited Competition for the Data Coordinating Center for Type I Diabetes TrialNet (UC4)" (Funding Opportunity Number RFA-DK-13-508), is a one-time, limited-competition Funding Opportunity Announcement from the National Institutes of Health (NIH). It is designed specifically to support the existing TrialNet Data Coordinating Center (TNCC) through a cooperative agreement (UC4). In practical terms, NIH is not looking for multiple new applicants or a brand-new coordinating center; the FOA invites a single application from the current TNCC Program Director/Principal Investigator to continue and expand TrialNet's work.
The scientific and public health focus is TrialNet's core mission: running clinical trials aimed at preventing type 1 diabetes. Under this award, the TNCC would be funded to conduct two new clinical trials or studies within the TrialNet consortium. The project period can last up to five years, with continuation dependent on satisfactory performance. The cooperative agreement mechanism signals substantial NIH involvement during the project, meaning NIH and the awardee are expected to work closely on trial planning, oversight, and execution rather than operating as a fully independent research grant.
A major part of the scope is operational and coordination heavy. The TNCC is expected to manage and support a complex, multi-site network that includes TrialNet Clinical Centers and Affiliate Centers, Core Laboratories, a Central Pharmacy, and other TrialNet contractors. This includes the real-world infrastructure needed to run prevention-focused clinical research across many sites: coordinating study start-up activities, harmonizing procedures across centers, supporting communications and logistics, and ensuring that trial operations remain consistent, compliant, and efficient across the consortium.
The FOA also places strong emphasis on the TNCC's technical responsibilities for trial methodology and data stewardship. The coordinating center is expected to provide biostatistical design and analysis support for the two new trials or studies, which typically includes protocol input on endpoints, power and sample size calculations, randomization approaches, interim monitoring considerations, and final analyses. On the data side, TNCC is responsible for data and sample management across the network, including standardized data acquisition, quality control processes, and the systems needed for handling biospecimens and associated metadata. Beyond internal management, the FOA highlights dissemination and public accessibility, indicating that TNCC must also support making data outputs available in a standardized, high-quality form consistent with NIH expectations for sharing and transparency.
From an administrative standpoint, the announcement was posted on November 7, 2013, with an original and current closing date of February 19, 2014, and an archive date of March 22, 2014. NIH anticipated making one award, with an estimated total funding amount of $25,000,000. The CFDA number listed is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), aligning the opportunity with NIH's diabetes-related research portfolio. There is no cost sharing or matching requirement stated for applicants.
Eligibility is intentionally narrow. The FOA is categorized as "limited competition" and is aimed at the existing TNCC leadership. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. Foreign components, as defined by the NIH Grants Policy Statement, are not allowed, which keeps the funded activities and components within allowable domestic boundaries for this specific opportunity.
For applicants or interested parties who want the full text, NIH provided an Additional Information link to the NIH grants guide page for RFA-DK-13-508. For access issues or technical problems linking to the announcement, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
1) What is the title of this grant opportunity?
The opportunity is titled "Limited Competition for the Data Coordinating Center for Type I Diabetes TrialNet (UC4)."
2) What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DK-13-508.
3) Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity.
4) Is this a one-time opportunity or an ongoing program announcement?
It is described as a one-time, limited-competition Funding Opportunity Announcement.
5) What does "limited competition" mean for this FOA?
Based on the information provided, NIH is not seeking multiple new applicants or a brand-new coordinating center. The FOA is designed to invite a single application from the current TrialNet Data Coordinating Center (TNCC) Program Director/Principal Investigator.
6) Who is the intended applicant for this FOA?
The FOA invites a single application from the existing TNCC Program Director/Principal Investigator to continue and expand TrialNet's work.
7) What is the award mechanism used for this opportunity?
The award mechanism is a cooperative agreement (UC4).
8) What does the cooperative agreement (UC4) imply about NIH involvement?
The cooperative agreement mechanism indicates substantial NIH involvement during the project period. NIH and the awardee are expected to work closely on trial planning, oversight, and execution, rather than operating as a fully independent research grant.
9) What is the scientific and public health focus of the work supported by this FOA?
The focus is TrialNet's core mission: running clinical trials aimed at preventing type 1 diabetes.
10) What activities is the TNCC expected to conduct under this award?
The TNCC would be funded to conduct two new clinical trials or studies within the TrialNet consortium.
11) How many awards does NIH anticipate making under this FOA?
NIH anticipated making one award.
12) What is the estimated total funding amount?
The estimated total funding amount is $25,000,000.
13) How long can the project period last?
The project period can last up to five years.
14) Is continued funding automatic for the full project period?
No. Continuation is dependent on satisfactory performance.
15) What types of network partners and components does the TNCC coordinate?
The TNCC is expected to manage and support a multi-site network that includes TrialNet Clinical Centers and Affiliate Centers, Core Laboratories, a Central Pharmacy, and other TrialNet contractors.
16) What are the TNCC's major operational and coordination responsibilities?
The scope is operational and coordination-heavy and includes coordinating study start-up activities, harmonizing procedures across centers, supporting communications and logistics, and ensuring trial operations remain consistent, compliant, and efficient across the consortium.
17) What biostatistical responsibilities are expected of the TNCC?
The TNCC is expected to provide biostatistical design and analysis support for the two new trials or studies. This typically includes protocol input on endpoints, power and sample size calculations, randomization approaches, interim monitoring considerations, and final analyses.
18) What data management responsibilities are expected of the TNCC?
The TNCC is responsible for data and sample management across the network, including standardized data acquisition, quality control processes, and the systems needed for handling biospecimens and associated metadata.
19) Does the FOA address data dissemination or public access expectations?
Yes. The FOA highlights dissemination and public accessibility, indicating the TNCC must support making data outputs available in a standardized, high-quality form consistent with NIH expectations for sharing and transparency.
20) What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
21) Is cost sharing or matching required?
No cost sharing or matching requirement is stated for applicants.
22) Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
23) Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are also not eligible.
24) Are foreign components allowed under this FOA?
No. Foreign components (as defined by the NIH Grants Policy Statement) are not allowed for this opportunity.
25) When was the FOA posted?
The announcement was posted on November 7, 2013.
26) What was the closing date for applications?
The original and current closing date listed is February 19, 2014.
27) When was the FOA archived?
The archive date is March 22, 2014.
28) Where can someone find the full FOA text?
NIH provided an Additional Information link to the NIH grants guide page for RFA-DK-13-508.
29) Who should be contacted for technical problems accessing the FOA link?
For access issues or technical problems linking to the announcement, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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