Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Biostatistics Research Center (Collaborative U01) | RFA DK 16 509

Opportunity Information: Apply for RFA DK 16 509

This funding opportunity, RFA-DK-16-509, is a National Institutes of Health (NIH) cooperative agreement (Collaborative U01) intended to support the continued follow-up of the Epidemiology of Diabetes Interventions and Complications (EDIC) cohort through an EDIC Biostatistics Research Center. EDIC is the long-running observational follow-up study that began in 1994 after the Diabetes Control and Complications Trial (DCCT) ended. DCCT established that intensive diabetes therapy substantially lowered the risk of complications compared with conventional therapy, and once the trial concluded, all participants were trained in intensive therapy. EDIC was then created to track what happens over the long term in this well-characterized type 1 diabetes population and to understand how earlier glycemic control and other risk factors shape outcomes many years later.

The FOA focuses on sustaining and strengthening the centralized biostatistics and data operations that make EDIC possible. The Biostatistics Research Center is expected to provide the statistical leadership and operational backbone for the study, supporting ongoing cohort follow-up and the broad range of analyses that come from EDIC data. The scientific emphasis is on the longer-term course of type 1 diabetes and the development and progression of complications, including (but not limited to) cardiovascular disease, mortality, severe microvascular outcomes such as blindness, kidney failure, and amputation, neurocognitive changes, and physical fragility. A key value of EDIC is that it has already shown durable benefits of prior intensive therapy and has produced detailed characterizations of how complications emerge and evolve; this FOA is designed to keep that momentum going by ensuring the cohort can continue to be followed and studied in a rigorous, consistent, and collaborative way.

On the operational side, the EDIC Biostatistics Research Center is responsible for managing and supporting EDIC-wide functions and analyses. That includes biostatistical study design and analysis planning, data management, management of samples and sample-related data, quality control and assurance activities, coordination with other EDIC core facilities and subcontractors, and ensuring results are disseminated effectively. The FOA also highlights public accessibility, signaling that the awardee should support mechanisms for making EDIC outputs available to the broader community in line with NIH expectations, while maintaining appropriate controls for participant privacy and data integrity. Because this is a cooperative agreement, NIH will have substantial programmatic involvement, and the work is expected to be conducted in close collaboration with the broader EDIC network rather than as a stand-alone, investigator-driven project.

This announcement is paired with a separate FOA, RFA-DK-16-508, which supports continuation of the EDIC Clinical Research Center. In other words, the clinical operations and the biostatistics/data coordinating functions are funded through linked opportunities, reflecting the structure of a large, multi-center longitudinal study where participant assessments and centralized data/statistical leadership must move in lockstep.

Eligibility is broad across U.S.-based organizations and government entities, including state, county, city/township, and special district governments; federally recognized tribal governments and other eligible tribal organizations; public and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (including small businesses); and other organizations as allowed under the FOA. The FOA also explicitly calls out a range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, along with faith-based and community-based organizations, eligible federal agencies, and U.S. territories or possessions, with the caveat to consult the full FOA for specific eligibility details. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components (as NIH defines them) may be allowed, which typically means discrete elements of the project can be conducted abroad under specific conditions while the applicant organization remains U.S.-based.

Key administrative details from the posting include an original application due date of November 8, 2016, a listed award ceiling of $2,500,000, and the CFDA number 93.847. Overall, the opportunity is best understood as continued infrastructure support for one of the most influential long-term type 1 diabetes cohort studies, with the Biostatistics Research Center serving as the hub for EDIC data stewardship, statistical rigor, coordination, and broad research enablement across the consortium.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Biostatistics Research Center (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.
• This funding opportunity was created on 2016-08-01.
• Applicants must submit their applications by 2016-11-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
• 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.

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