Opportunity Information: Apply for RFA DK 13 009

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Type 1 Diabetes TrialNet Clinical Network Hub (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 Jun 18, 2013 and posted on Jun 18, 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.
  • Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments.
  • 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The funding opportunity titled "Type 1 Diabetes TrialNet Clinical Network Hub (U01)" (Funding Opportunity Number RFA-DK-13-009) is a National Institutes of Health (NIH) cooperative agreement designed to support the creation and operation of a new infrastructure unit within the Type 1 Diabetes TrialNet program, called the Clinical Network Hub (CNH). Rather than funding a single clinical trial or a standalone research project, this award focuses on building and coordinating the operational backbone that helps TrialNet run more smoothly. The central idea is to strengthen how TrialNet screens people at risk for type 1 diabetes, recruits participants, and conducts clinical studies across the network, with an emphasis on efficiency, flexibility, and faster, better decision-making.

The CNH is intended to function as a screening and clinical activities coordination unit. In practical terms, that means the awardee would be responsible for organizing and improving the way TrialNet sites and partners handle risk screening (including identifying individuals who may be in early or pre-symptomatic stages of type 1 diabetes), coordinating participant recruitment pipelines, and supporting the implementation of TrialNet trials and related clinical activities. A major theme in the announcement is operational improvement: making screening more efficient, testing and rolling out new and creative screening and recruitment approaches, and reducing bottlenecks that slow down trial start-up or ongoing study operations.

Another key purpose of creating the CNH is to enable restructuring of TrialNet's organizational leadership. NIH is signaling that TrialNet can benefit from a refreshed leadership and coordination model that improves responsiveness and streamlines decisions across the network. The CNH is positioned as a vehicle for that change, with the expectation that a dedicated hub can help standardize processes, improve coordination across multiple clinical sites, and adapt quickly when TrialNet priorities shift or when new trial opportunities emerge.

This opportunity is offered as a cooperative agreement (U01), which generally means NIH expects to have substantial scientific and programmatic involvement during the project. In other words, the award is not just "hands-off" funding; it typically involves ongoing collaboration with NIH staff and alignment with TrialNet program needs, milestones, and network-wide coordination expectations. The activity category is listed under health (with a "Food and Nutrition Health" label in the source data), and the CFDA number is 93.847, which corresponds to Diabetes, Digestive, and Kidney Diseases Extramural Research.

Funding details indicate an expected single award, with an estimated total funding amount of $2,000,000 and an award ceiling of $2,000,000. There is no cost sharing or matching requirement. The opportunity was posted on June 18, 2013, and the original and current closing date was November 27, 2013, with the archive date of December 28, 2013, indicating it is no longer active but remains useful as a reference point for how NIH structures TrialNet infrastructure solicitations.

Eligibility is broad and includes many domestic organization types: state, county, city/township governments, special district governments, independent school districts, tribal governments (federally recognized and other than federally recognized), public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses. The FOA also explicitly includes a range of mission- or population-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. Non-U.S. (foreign) institutions are not eligible to apply as the primary applicant; however, non-domestic components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowed, which typically means certain project elements could be conducted abroad if appropriately justified and compliant with NIH rules.

For applicants or reviewers trying to understand what NIH was seeking, the short version is that the CNH was meant to be a high-impact coordination center that improves the "engine room" of TrialNet: better screening throughput, more effective recruitment strategies, smoother trial execution, and a more agile network structure. The official announcement link was provided through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-009.html, and NIH listed the Office of Extramural Research (OER) webmaster contacts for access and technical issues related to the posting.

Frequently Asked Questions (FAQs): Type 1 Diabetes TrialNet Clinical Network Hub (U01)

What is the funding opportunity called and what is the FOA number?

The opportunity is titled "Type 1 Diabetes TrialNet Clinical Network Hub (U01)." The Funding Opportunity Number (FOA) is RFA-DK-13-009.

Which agency is offering this opportunity?

This is a National Institutes of Health (NIH) funding opportunity, tied to the Type 1 Diabetes TrialNet program.

What type of award mechanism is this?

The mechanism is a cooperative agreement (U01). This typically indicates NIH expects substantial scientific and programmatic involvement during the project rather than purely hands-off grant support.

What is being funded: a clinical trial or an infrastructure function?

This award is designed to create and operate an infrastructure unit within TrialNet called the Clinical Network Hub (CNH). It is not aimed at funding a single standalone clinical trial or a traditional independent research project.

What is the Clinical Network Hub (CNH)?

The CNH is intended to function as a screening and clinical activities coordination unit for the Type 1 Diabetes TrialNet program. The focus is on improving how TrialNet sites and partners coordinate screening, recruitment, and execution of clinical studies across the network.

What are the main goals of the CNH?

The CNH is intended to strengthen TrialNet operations by improving efficiency, flexibility, and decision-making across network screening and clinical activities. Key themes include reducing bottlenecks, improving start-up and ongoing study operations, and enabling faster and better operational decisions.

What kinds of activities would the CNH coordinate?

Based on the description, the CNH would coordinate and improve processes related to:

  • Risk screening for type 1 diabetes (including identifying individuals who may be in early or pre-symptomatic stages)
  • Participant recruitment pipelines across TrialNet sites and partners
  • Support for implementation of TrialNet trials and related clinical activities

What does "risk screening" mean in the context of this opportunity?

The opportunity emphasizes screening people at risk for type 1 diabetes, including identifying individuals who may be in early or pre-symptomatic stages of the disease. The CNH is expected to improve the efficiency and throughput of these screening efforts.

Does the FOA emphasize testing new approaches to screening and recruitment?

Yes. A major theme is operational improvement, including testing and rolling out new and creative screening and recruitment approaches, with the goal of making TrialNet screening more efficient and reducing operational bottlenecks.

How does the CNH relate to TrialNet leadership and governance?

One purpose of creating the CNH is to enable restructuring of TrialNet's organizational leadership. NIH signals an interest in a refreshed leadership and coordination model that improves responsiveness and streamlines decisions across the network, with the CNH serving as a vehicle to help standardize processes and improve network-wide coordination.

What does it mean that this is a cooperative agreement (U01) for project operations?

It means the award is expected to involve ongoing collaboration with NIH staff and alignment with TrialNet program needs, milestones, and network-wide coordination expectations, rather than operating entirely independently.

How many awards were expected under this FOA?

The funding details indicate NIH expected a single award.

What is the total estimated funding amount and the maximum award amount?

The estimated total funding amount is $2,000,000, and the award ceiling is also $2,000,000.

Is cost sharing or matching required?

No. The opportunity specifies that there is no cost sharing or matching requirement.

What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.847, corresponding to Diabetes, Digestive, and Kidney Diseases Extramural Research.

What activity category is associated with this FOA?

The activity is listed under health (with a "Food and Nutrition Health" label in the source data).

When was this opportunity posted?

The opportunity was posted on June 18, 2013.

What were the closing date and archive date?

The original and current closing date was November 27, 2013. The archive date was December 28, 2013.

Is this funding opportunity still active?

No. The closing and archive dates indicate the opportunity is no longer active, though it remains useful as a reference for how NIH structures TrialNet infrastructure solicitations.

Who was eligible to apply?

Eligibility was broad and included many U.S. (domestic) organization types, including:

  • State, county, and city/township governments
  • Special district governments
  • Independent school districts
  • Tribal governments (federally recognized and other than federally recognized)
  • Public and private institutions of higher education
  • Nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations)
  • Public housing authorities / Indian housing authorities
  • Small businesses
  • For-profit organizations other than small businesses
  • Eligible federal agencies
  • Faith-based or community-based organizations

Were certain institution types explicitly included?

Yes. The FOA explicitly includes institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are non-U.S. (foreign) institutions eligible to apply as the primary applicant?

No. Non-U.S. (foreign) institutions are not eligible to apply as the primary applicant under this opportunity.

Can foreign components participate in any way?

Yes. While foreign institutions cannot apply as the primary applicant, non-domestic components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowed. This generally means certain project elements could be conducted abroad if properly justified and compliant with NIH rules.

What was NIH looking for in an ideal CNH concept?

The description emphasizes a high-impact coordination center that improves the operational "engine room" of TrialNet: better screening throughput, more effective recruitment strategies, smoother trial execution across multiple sites, and a more agile network structure that can adapt quickly to shifting priorities and new trial opportunities.

Where was the official announcement posted?

The official announcement was available via the NIH Grants Guide at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-009.html

Who was listed for technical or access issues related to the posting?

NIH listed Office of Extramural Research (OER) webmaster contacts for access and technical issues related to the posting.

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