Data Management Coordinating Center for Diagnostic Centers of Excellence (U2C Clinical Trial Not Allowed) | RFA NS 22 051

Opportunity Information: Apply for RFA NS 22 051

This NIH funding opportunity (RFA-NS-22-051) supports the creation of a Data Management and Coordinating Center (DMCC) that will serve as the backbone for a new national network of clinical sites focused on diagnosing people with undiagnosed diseases. The goal is to preserve and carry forward key research and diagnostic coordination functions that have been handled by the Undiagnosed Diseases Network (UDN), a 2013 NIH Common Fund initiative that is scheduled to sunset in 2023. Rather than directly funding each diagnostic site through this announcement, NIH is seeking one central coordinating entity that can build and operate the shared infrastructure, data systems, and cross-site support needed for the network to function as a coherent, research-enabled enterprise.

The award mechanism is a U2C cooperative agreement, which means NIH will have substantial involvement in the project compared with a typical grant. Clinical trials are not allowed under this FOA. The DMCC is expected to coordinate a set of clinical sites that will join the new network as Diagnostic Centers of Excellence (DCoEs). Those DCoEs will enter the network through a separate NIH Resource Access Program (X01) process beginning in fiscal year 2023, and the DMCC will be responsible for helping integrate these sites into common workflows, shared standards, and network-wide activities. In addition to supporting the DCoEs, the DMCC will also support the NIH intramural Undiagnosed Diseases Program (UDP), helping align intramural and extramural efforts and enabling trans-network research activities.

Functionally, NIH describes the DMCC’s work as being organized across three coordinated cores. First, an Administrative Core would handle overall network coordination, governance support, meeting logistics, communication, standard operating procedures, and the practical project management needed to keep multiple sites operating in sync. Second, a Data Management Core would provide the network’s data backbone, including systems and processes for collecting, harmonizing, storing, curating, sharing, and reporting data generated across diagnostic sites. This typically includes common data elements, data quality controls, secure data transfer, access policies, and compliance practices appropriate for sensitive clinical information. Third, a Clinical Research Support Core would provide hands-on support for multi-site clinical research operations that sit alongside diagnostic activity, such as coordinating protocol-related activities that are not clinical trials, supporting IRB-related coordination approaches when applicable, enabling standardized phenotyping and case review processes, and helping the network conduct cross-site analyses and research that arise from diagnostic evaluations. Taken together, these cores are meant to make it possible for the DCoEs to focus on delivering advanced diagnostics while still contributing to consistent, high-quality research data and network learning.

Eligible applicants are broad and include many types of U.S.-based organizations and governments, such as state, county, city/township, and special district governments; federally recognized tribal governments and certain tribal organizations; public and private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible categories 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 U.S. territories or possessions. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components are allowed if they meet the NIH definition in the NIH Grants Policy Statement, which generally means limited, well-justified foreign involvement can be part of a U.S.-led application.

The sponsoring agency is the National Institutes of Health, and the activity sits within NIH’s health mission space. The opportunity lists multiple CFDA (Assistance Listing) numbers: 93.172, 93.846, 93.853, 93.855, and 93.867, reflecting the cross-institute nature of undiagnosed disease efforts and the way NIH may administratively align the award. The original application due date was August 10, 2022, and the opportunity was created June 6, 2022. The listed award ceiling is $3,000,000, indicating the maximum anticipated annual budget level per award under this announcement, with the expectation that the DMCC will operate at a scale large enough to support multiple diagnostic sites, a central data platform, and network-wide coordination functions.

In practical terms, applicants to this FOA would be proposing to become the central hub that makes the new undiagnosed diseases diagnostic network run smoothly: setting up the operational playbook, providing the shared data and informatics infrastructure, ensuring consistent and secure data handling, and supplying the coordinating and clinical research support functions that allow geographically distributed DCoEs and the NIH intramural UDP to operate as a unified network rather than isolated sites.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Management Coordinating Center for Diagnostic Centers of Excellence (U2C Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.846, 93.853, 93.855, 93.867.
• This funding opportunity was created on 2022-06-06.
• Applicants must submit their applications by 2022-08-10. (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 $3,000,000.00 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.

Apply for RFA NS 22 051

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