Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54 Clinical Trials Optional) | RFA TR 18 020

Opportunity Information: Apply for RFA TR 18 020

The Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) opportunity (RFA-TR-18-020) is a National Institutes of Health (NIH) funding announcement that supports the creation or continuation of collaborative consortia focused on improving how rare diseases are diagnosed, managed, and treated, with a strong emphasis on clinical trial readiness. It uses the U54 cooperative agreement mechanism, which typically means the work is carried out as a partnership between the funded consortium and NIH program staff, with ongoing coordination and shared responsibilities rather than a completely investigator-directed grant. Clinical trials are optional under this announcement, but the core expectation is that the consortiums work in a way that moves the field closer to being able to run informative, feasible, and patient-centered trials in rare diseases.

A central goal of the FOA is to strengthen multi-site, highly collaborative, translational and clinical research efforts that can overcome common barriers in rare disease research, such as small patient populations, fragmented expertise, limited natural history data, inconsistent outcome measures, and the need for validated biomarkers or endpoints. By organizing investigators, clinical sites, and patient communities into a structured network, the RDCRCs are intended to generate the kind of shared infrastructure and coordinated research plans that make future trials more realistic and more likely to succeed. The program is explicitly patient-centric, signaling that applicants are expected to meaningfully engage patients, families, and advocacy organizations and to design studies and processes that reflect patient needs and real-world burden.

The eligible applicant pool is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants listed 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; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized governments; nonprofit organizations with and without 501(c)(3) status (as long as they are not institutions of higher education in that category listing); for-profit organizations (other than small businesses); small businesses; and other organizations. The announcement also highlights specific categories of eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

At the same time, the FOA places clear limits on foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined under the NIH Grants Policy Statement, which generally means a U.S. applicant can include certain international collaborators or performance sites as part of the overall project when they provide unique expertise, populations, or resources that strengthen the science and can be justified within NIH policy.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses a cooperative agreement as the funding instrument. The activity category is listed broadly across areas such as health, education, and social services, reflecting the cross-cutting nature of rare disease work and the network model. Multiple CFDA numbers are associated with the announcement, indicating participation or alignment across NIH institutes and centers that support rare diseases and related clinical research infrastructure. The original closing date shown is October 9, 2018, and the record creation date is June 8, 2018, which helps place this FOA in time as a specific competition cycle for RDCRN consortia rather than a standing, always-open program.

In practical terms, the RDCRC model is designed to bring together multiple clinical sites and stakeholders to produce shared datasets, harmonized protocols, and tools that make rare disease studies more efficient and comparable across locations. The “clinical trial readiness” focus typically implies activities like building or expanding patient cohorts and registries, conducting natural history studies, developing and validating outcome measures that matter clinically and to patients, identifying biomarkers, improving diagnostic pathways, and establishing operational capabilities (recruitment strategies, data standards, and multi-site coordination) that reduce the friction of launching trials. Even when an application does not propose a trial, the expectation is that the consortium’s research program and infrastructure development will measurably close gaps that have been preventing trials or limiting their interpretability.

Overall, this FOA funds networked, multi-site rare disease clinical research consortia that can coordinate expertise and patient engagement to tackle the foundational work needed before trials can be conducted effectively. It is aimed at moving rare disease fields from scattered studies toward organized, shared clinical research programs that can support stronger evidence generation and, ultimately, better treatments and care pathways.

• The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54 Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.233, 93.350, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.865.
• This funding opportunity was created on 2018-06-08.
• Applicants must submit their applications by 2018-10-09. (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 $100,000.00 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 TR 18 020

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