This Notice of Funding Opportunity (NOFO) invites applications for the Rare Diseases Clinical Research Consortia (RDCRC) as part of the Rare Diseases Clinical Research Network (RDCRN). The goal is to improve the diagnosis, management, and treatment of rare diseases through collaborative, multi-site, patient-centric research. Emphasis is placed on early identification and clinical trial readiness.

Funding Opportunity Details

The National Institutes of Health (NIH), including various institutes such as NCATS, NHLBI, NHGRI, NIA, NIAID, NIAMS, NICHD, NIDCR, NIDDK, and NINDS, are participating organizations. This initiative utilizes the U54 Specialized Center - Cooperative Agreements mechanism to support translational and clinical research in rare diseases.

The primary objective is to translate research observations into effective health solutions for rare diseases. This includes developing and enhancing diagnostics and therapeutics, understanding commonalities across different rare diseases, and improving clinical trial methodologies to better reflect patient populations.

The Funding Opportunity Number (FON) for this announcement is PAR-25-438. This is a reissue of PAR-24-206. The Assistance Listing Numbers include 93.350, 93.855, 93.866, 93.853, 93.172, 93.846, 93.837, 93.233, 93.838, 93.839, 93.840, 93.121, 93.865, 93.847.

Key Dates and Deadlines

The Posted Date and Open Date (Earliest Submission Date) is June 05, 2025. There is no Letter of Intent Due Date for this funding opportunity.

There are two application due dates: July 07, 2025 and October 16, 2025, both by 5:00 PM local time of the applicant organization. These dates apply to both new and renewal/resubmission/revision applications. Applicants should submit early to allow time for corrections. The Expiration Date for this NOFO is October 17, 2025.

Scientific merit reviews are scheduled for July 2025 and March 2026, with advisory council reviews in August 2025 and May 2026, respectively. The earliest start dates are projected for September 2025 and July 2026.

Eligibility and Application Instructions

Applicants must adhere to the Multi-Project (M) Instructions in the How to Apply - Application Guide. Strict compliance with all requirements in the guide and the NOFO is mandatory. Non-compliant applications may face delays or rejection.

Applicants can submit applications through Grants.gov using either the NIH ASSIST system or an institutional system-to-system (S2S) solution. Check with your institutional officials regarding the availability of S2S.

It is crucial to follow both the general instructions in the How to Apply - Application Guide and the program-specific instructions outlined in Section IV of this NOFO. In cases of conflict, the program-specific instructions take precedence.

Research Focus Areas

The RDCRN supports research across a broad spectrum of rare diseases. The focus is on translational and clinical research aimed at improving diagnosis, management, and treatment. Special emphasis is placed on early identification of individuals with rare diseases and enhancing clinical trial readiness.

NCATS' mission is to translate research observations into health solutions through translational science. Key approaches include understanding what’s similar across diseases to spur multiple treatments at a time, developing models that better predict a person’s reaction to treatment, enhancing clinical trials so results more accurately reflect the patient population, and leveraging real-world data and data science approaches to address public health needs.

The RDCRC program encourages collaborative, multi-site research projects. These projects should be patient-centric and designed to address critical gaps in the understanding and treatment of rare diseases.