Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional) | PAR 25 438

Opportunity Information: Apply for PAR 25 438

The Rare Diseases Clinical Research Consortia (RDCRC) funding opportunity (PAR-25-438) supports the formation and continuation of consortia that make up the Rare Diseases Clinical Research Network (RDCRN). Using the U54 cooperative agreement mechanism (with clinical trials allowed but not required), the program is designed to bring together multi-site teams that can move rare disease research forward in a practical, patient-focused way. The overall goal is to improve how rare diseases are diagnosed, managed, and treated by supporting collaborative translational and clinical research that individual sites typically cannot accomplish alone, especially when patient populations are small and geographically dispersed.

A central priority in this NOFO is accelerating earlier and more timely identification of people living with rare diseases and improving clinical trial readiness. In practice, that emphasis points applicants toward building systems and workflows that shorten the diagnostic journey, strengthen patient identification and referral pathways, and develop the infrastructure needed to run well-designed studies. That can include assembling cohorts across multiple clinical sites, harmonizing data and clinical assessments, developing or validating outcome measures, and setting up recruitment strategies that are realistic for rare conditions. The NOFO frames RDCRCs as “patient-centric,” which signals that patient engagement, feasible participation across sites, and research that directly addresses patient needs should be built into the consortium’s design rather than treated as an add-on.

Because this is a cooperative agreement, awardees should expect a more involved partnership with NIH compared with a standard research grant. Cooperative agreements typically mean NIH staff have substantial programmatic involvement, which often includes coordination across the broader RDCRN, alignment on network policies, shared expectations around data standards and collaboration, and active participation in network-wide activities. The intent is to create a connected network of consortia that can learn from one another, share tools and practices, and collectively raise the quality and efficiency of rare disease clinical research.

Eligibility is broad and includes many U.S. organization types such as public and private institutions of higher education, nonprofit organizations (including those with 501(c)(3) status), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special district), as well as federally recognized tribal governments and other tribal organizations, independent school districts, and public housing authorities/Indian housing authorities. The NOFO also states that non-U.S. entities (foreign organizations) may apply. At the same time, it draws a bright line on foreign components: non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH Grants Policy) are not allowed. In other words, a foreign organization can be the applicant, but a U.S. applicant cannot include a foreign component within its project structure under NIH’s definition.

Key administrative details provided in the posting include an original application due date of October 16, 2025, and an award ceiling listed at $1,000,000. The sponsoring agency is the National Institutes of Health, and the opportunity is categorized under Health with multiple CFDA listings (93.121, 93.172, 93.233, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866), reflecting the cross-institute nature typical of RDCRN efforts. Overall, the NOFO is aimed at building or sustaining robust, multi-institution rare disease research consortia that can identify patients sooner, prepare efficiently for trials, and generate clinically meaningful evidence that improves real-world care.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.172, 93.233, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866.
• This funding opportunity was created on 2025-06-05.
• Applicants must submit their applications by 2025-10-16. (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 $1,000,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 438

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