Opportunity Information: Apply for RFA DK 16 503

  • The HHS-NIH11 in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Collaborative Islet Transplantation Registry (UC4)" 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 Jun 14, 2016 and posted on Jun 14, 2016.
  • Applicants must submit their applications by Nov 21, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA DK 16 503

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Opportunity Summary:

The Limited Competition for the Continuation of the Collaborative Islet Transplantation Registry (CITR) (UC4) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-DK-16-503) issued by HHS/NIH. Its purpose is to support the ongoing operation of the Collaborative Islet Transplantation Registry, a long-running North American registry that has been compiling and analyzing clinical islet transplantation data since 2001. The central idea is continuity: keeping a mature, established registry functioning so it can keep capturing real-world clinical activity, standardizing information across sites, and turning those data into usable evidence for the broader research and clinical community.

The work funded under this opportunity focuses on maintaining and advancing a comprehensive data-collection and analytics infrastructure for islet transplantation. The awardee is expected to collect islet transplant data and to develop, manage, and maintain sophisticated databases that can be used by researchers for scientific publications and conference presentations. In practice, that means not just storing records, but building and sustaining a reliable, secure, and well-curated data system that supports longitudinal tracking, quality control, and meaningful analysis across many years of clinical practice. By continuing to capture all (or as close as possible to all) clinical islet transplantation activity in North America, the registry serves as a centralized resource that allows trends and outcomes to be evaluated in a way that individual centers typically cannot do on their own.

A key required product of the registry is a public-facing annual report. This report is intended to summarize outcomes of islet transplantation and document trends over time, giving clinicians, researchers, policymakers, and the public a transparent view into how the field is performing and evolving. The annual reporting function is important because it translates complex clinical and procedural data into an accessible snapshot of safety and effectiveness, and it helps establish benchmarks that can inform future research, clinical guidelines, and discussions about best practices.

From a scientific and public health standpoint, the registry is positioned as a tool to improve therapy for people with type 1 diabetes by helping the field understand what drives success or failure in islet transplantation. By collecting and analyzing consistent information over time, CITR data can be used to identify risk factors, detect patterns linked to complications, and clarify the key safety and efficacy determinants associated with successful outcomes. That kind of evidence is especially valuable for a specialized therapy like islet transplantation, where case volumes may be relatively limited at any single institution and where outcomes can be influenced by many variables related to patient selection, processing methods, immunosuppression strategies, and post-transplant management.

Administratively, this is a discretionary funding opportunity using the Cooperative Agreement mechanism (UC4), which generally signals substantial programmatic involvement by NIH compared to a standard grant. The listing includes CFDA numbers 93.847 and indicates an expectation of a single award. The opportunity was posted and created on June 14, 2016, with an application closing date of November 21, 2016. Eligibility is broad on paper, spanning multiple levels of government, public and private institutions of higher education, tribal entities, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and other applicants as specified in the full announcement. Despite the broad eligibility language, the title and framing as a limited competition strongly suggest it is intended for a small set of qualified organizations capable of sustaining a specialized, continent-wide clinical registry with the needed technical, clinical, and regulatory expertise.

Overall, this funding opportunity is essentially about sustaining a critical shared research infrastructure for the islet transplantation field: continued comprehensive data capture across North America, ongoing database development and maintenance for research use, and routine public reporting of outcomes and trends. The longer-term payoff is improved understanding of what makes islet transplantation safer and more effective for patients with type 1 diabetes, grounded in a large, standardized, longitudinal evidence base.

Frequently Asked Questions (FAQs)

What is this grant opportunity?

This is the Limited Competition for the Continuation of the Collaborative Islet Transplantation Registry (CITR) (UC4), a National Institutes of Health (NIH) cooperative agreement funding opportunity issued by HHS/NIH under RFA-DK-16-503.

What is the purpose of this funding opportunity?

The purpose is to support the ongoing operation of the Collaborative Islet Transplantation Registry (CITR), a long-running North American registry that has been compiling and analyzing clinical islet transplantation data since 2001. The core emphasis is continuity: keeping a mature, established registry functioning so it can continue capturing real-world clinical activity, standardizing information across sites, and producing usable evidence for the research and clinical community.

What is CITR?

CITR is a North American registry focused on clinical islet transplantation. It serves as a centralized resource for compiling, standardizing, and analyzing outcomes and trends that individual centers may not be able to evaluate on their own due to limited local case volumes.

Since when has CITR been compiling data?

CITR has been compiling and analyzing clinical islet transplantation data since 2001.

What type of NIH funding mechanism is used?

The opportunity uses the Cooperative Agreement mechanism (UC4), which generally indicates substantial NIH programmatic involvement compared to a standard grant.

What kind of work is expected to be supported by the award?

The funded work focuses on maintaining and advancing a comprehensive data-collection and analytics infrastructure for islet transplantation. This includes collecting islet transplant data and developing, managing, and maintaining sophisticated databases that support longitudinal tracking, quality control, and meaningful analysis across many years of clinical practice.

Is the award mainly about research studies or infrastructure?

Based on the description, the award is primarily about sustaining and improving shared research infrastructure: a reliable, secure, well-curated registry and database environment that enables ongoing capture and analysis of clinical islet transplantation activity.

What are the key deliverables or required outputs?

A key required product is a public-facing annual report that summarizes outcomes of islet transplantation and documents trends over time. The registry is also expected to maintain databases suitable for researchers to use for scientific publications and conference presentations.

What is the annual report expected to cover?

The annual report is intended to summarize outcomes of islet transplantation and document trends over time, offering a transparent view into how the field is performing and evolving for clinicians, researchers, policymakers, and the public.

Why is a public annual report emphasized?

The annual reporting function translates complex clinical and procedural data into an accessible snapshot of safety and effectiveness, helps establish benchmarks, and can inform future research, clinical guidelines, and discussions about best practices.

What kinds of data activities are anticipated?

The opportunity emphasizes comprehensive data capture, standardization of information across sites, longitudinal tracking, quality control, and analytics that enable evaluation of trends and outcomes across many years of clinical practice.

What is meant by capturing "all (or as close as possible to all)" clinical islet transplantation activity?

This refers to the goal of making the registry as comprehensive as possible for North America, so outcomes and trends can be evaluated using a centralized dataset rather than fragmented, center-specific snapshots.

How can CITR data be used by the broader community?

The registry is expected to maintain databases that can be used by researchers for scientific publications and conference presentations, supporting broader research and clinical learning from standardized, longitudinal data.

What public health or scientific impact is the registry intended to have?

The registry is positioned as a tool to improve therapy for people with type 1 diabetes by helping the field understand what drives success or failure in islet transplantation. By analyzing consistent information over time, CITR data can help identify risk factors, detect patterns linked to complications, and clarify safety and efficacy determinants associated with successful outcomes.

Why is a centralized registry especially valuable in islet transplantation?

Islet transplantation is described as a specialized therapy where case volumes may be limited at any single institution and outcomes can be influenced by many variables (such as patient selection, processing methods, immunosuppression strategies, and post-transplant management). A centralized registry enables evaluation of trends and outcomes that single centers typically cannot do on their own.

What is the awarding agency?

The awarding agency is HHS/NIH (National Institutes of Health).

What is the funding opportunity number?

The funding opportunity is identified as RFA-DK-16-503.

What CFDA numbers are associated with this opportunity?

The listing includes CFDA numbers 93.847.

Is this a competitive program with multiple awards?

The opportunity indicates an expectation of a single award.

What does "limited competition" imply here?

While the eligibility language is broad, the title and framing as a limited competition strongly suggest the opportunity is intended for a small set of qualified organizations capable of sustaining a specialized, continent-wide clinical registry with the necessary technical, clinical, and regulatory expertise.

Who is eligible to apply?

Eligibility is described as broad and includes multiple levels of government, public and private institutions of higher education, tribal entities, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and other applicants as specified in the full announcement.

When was this opportunity posted and created?

The opportunity was posted and created on June 14, 2016.

What was the application closing date?

The application closing date was November 21, 2016.

What geographic scope is emphasized for the registry?

The registry is described as a North American registry, with an emphasis on capturing clinical islet transplantation activity across North America.

What is the long-term goal of continuing CITR?

The longer-term payoff described is improved understanding of what makes islet transplantation safer and more effective for patients with type 1 diabetes, grounded in a large, standardized, longitudinal evidence base.

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