Diagnostic Centers of Excellence (X01 Clinical Trial Not Allowed) | PAR 23 171

Opportunity Information: Apply for PAR 23 171

The Diagnostic Centers of Excellence (X01 Clinical Trial Not Allowed) opportunity (PAR 23 171) is a National Institutes of Health (NIH) funding announcement designed to plug investigators and clinical sites into shared, centralized resources that support the next phase of the Undiagnosed Diseases Network (UDN). Rather than primarily paying an applicant to build a standalone program from scratch, this mechanism is focused on enabling access to an existing backbone of support operated by the Data Management Coordinating Center for Diagnostic Centers of Excellence (referenced as RFA-NS-22-051). In practical terms, the award is meant to help a new network of clinical sites deliver diagnostic services for patients with challenging, unresolved conditions by using common infrastructure, coordinated data systems, and standardized clinical research support.

A central feature of the FOA is the provision of network-level resources: infrastructure to run complex, multi-site diagnostic efforts; data management capabilities to capture, curate, harmonize, and share information across sites; and clinical research support to help participating centers operate consistently within the network. The overall goal is to improve the ability of clinical programs to evaluate patients with undiagnosed diseases by making sure participating sites are not operating in isolation, and by ensuring that data produced through these evaluations can be managed and coordinated in a uniform way across the network. This aligns with the UDN mission of accelerating diagnosis and knowledge generation for rare and previously undiagnosed conditions, where progress often depends on pooling expertise, cases, and high-quality structured data.

This FOA is explicitly labeled "Clinical Trial Not Allowed," which signals that applications proposing clinical trials as defined by NIH will not be accepted under this mechanism. The emphasis is on diagnostic evaluation and associated clinical research support activities within a coordinated network context, not on interventional studies that assign participants to interventions to evaluate health-related outcomes. Applicants should read that restriction as a boundary on study design: projects need to fit within non-trial activities consistent with providing diagnostic services and related data and research coordination.

Eligibility is broad across government, academic, nonprofit, and private-sector organizations. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (so long as they are not institutions of higher education in that category listing), for-profit organizations other than small businesses, and small businesses. In addition to these standard categories, the announcement highlights "Other Eligible Applicants" such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

Foreign participation is constrained in a way that is typical for many NIH opportunities but is spelled out clearly here. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) foreign institutions are not eligible to apply as applicants, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain types of foreign involvement when it meets NIH's definition and requirements for a foreign component (for example, a discrete project element performed outside the U.S.), subject to NIH rules and approvals.

Administratively, the opportunity is categorized as discretionary and uses a grant funding instrument. It sits under a broad set of CFDA numbers (including 93.113, 93.121, 93.172, 93.233, 93.350, and several 93.8xx lines), reflecting NIH's multi-institute structure and the cross-cutting nature of undiagnosed and rare disease work. The opportunity was created on 2023-04-06, and the original closing date listed is 2025-05-15. The award ceiling and expected number of awards are not specified in the provided source data, which usually means applicants should consult the full FOA text and any related NIH guidance for budget expectations, scope, and how NIH anticipates making and structuring awards.

Overall, this announcement is best read as an entry point into an organized diagnostic network: it is for groups that want to participate in a coordinated system for evaluating undiagnosed disease patients, and that can benefit from shared data management and clinical research support rather than duplicating those capabilities locally. The value proposition is the ability to operate as part of a standardized, networked effort where cases, data, and diagnostic learning can be managed consistently and leveraged across multiple clinical sites.

• The National Institutes of Health in the environment, health, income security and social services sector is offering a public funding opportunity titled "Diagnostic Centers of Excellence (X01 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): 93.113, 93.121, 93.172, 93.233, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.855, 93.865, 93.867.
• This funding opportunity was created on 2023-04-06.
• Applicants must submit their applications by 2025-05-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 PAR 23 171

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