Limited Competition for the Continuation of Clinical Sites for the Undiagnosed Diseases Network (U01 Clinical Trial Not Allowed) | RFA NS 23 004

Opportunity Information: Apply for RFA NS 23 004

This grant opportunity, titled "Limited Competition for the Continuation of Clinical Sites for the Undiagnosed Diseases Network (U01 Clinical Trial Not Allowed)," is an NIH funding announcement designed to provide a short, one-year extension of support for existing Undiagnosed Diseases Network (UDN) Clinical Sites. It is a limited competition, meaning it is not broadly open to new clinical sites; instead, it is specifically intended for clinical sites that previously received NIH awards under RFA-RM-17-019. The overall goal is to avoid disruption between phases of the UDN program by allowing these established sites to keep operating while they transition and align with the next phase of the network.

The primary purpose of the one-year funding period is continuity and readiness. Funded clinical sites are expected to continue participating in UDN activities, maintain momentum in diagnosing and evaluating patients with rare and difficult-to-diagnose conditions, and ensure that essential clinical operations do not stall. A key expectation is that sites use this extension period to establish or strengthen collaborations and efficient working processes with the next-phase Data Management and Coordinating Center (DMCC), referenced as RFA-NS-22-051. In practical terms, this means harmonizing workflows for data intake, sharing, quality control, reporting, and coordination so that the clinical sites can integrate smoothly with updated network infrastructure and expectations.

In addition to maintaining ongoing UDN involvement, the opportunity emphasizes continued participant-facing work. Clinical sites are expected to enroll and evaluate new participants during the extension year, supporting the network mission of investigating undiagnosed conditions through comprehensive clinical evaluation and coordinated research efforts. At the same time, the announcement makes clear that sites should actively advance their sustainability plans. This reflects NIH interest in ensuring that clinical sites are not only operating effectively in the short term, but also building strategies for longer-term viability, whether through diversified funding, institutional support, operational efficiencies, partnerships, or other durable models that can keep rare disease diagnostic capacity functioning beyond a single award period.

The award mechanism is a cooperative agreement (U01), which typically indicates substantial NIH program involvement compared with a standard research project grant. The activity area is health, and the associated CFDA numbers listed are 93.172 and 93.853. The funding opportunity number is RFA-NS-23-004, administered by the National Institutes of Health. The posted award ceiling is $400,000, and the original application due date was 2022-09-02, with the announcement created on 2022-07-22. The announcement also clearly states "Clinical Trial Not Allowed," signaling that the funded activities cannot include a clinical trial as defined by NIH policy, even though the work involves clinical evaluation and participant enrollment.

Eligibility is described in two layers. First, the competition is functionally restricted to UDN Clinical Sites previously funded under the specified prior RFA (RFA-RM-17-019), which is the defining limitation. The listing also notes a range of eligible applicant categories, including certain public and tribal entities (for example, independent school districts, federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and other tribal organizations). It further notes that eligible agencies of the federal government, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions may be eligible in general terms. However, foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. At the same time, foreign components (as defined in the NIH Grants Policy Statement) are allowed, which typically means a U.S.-based applicant organization may include a defined foreign component in the project when scientifically justified and consistent with NIH policy, even though a non-U.S. institution cannot serve as the applicant.

Overall, this opportunity is best understood as a bridge year for established UDN clinical sites: keep seeing and evaluating undiagnosed patients, keep the network functioning, prepare operationally and collaboratively for the next DMCC-supported phase, and use the time to strengthen sustainability so the diagnostic and research capacity built by the UDN can continue without interruption.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Clinical Sites for the Undiagnosed Diseases Network (U01 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, 93.853.
• This funding opportunity was created on 2022-07-22.
• Applicants must submit their applications by 2022-09-02. (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 $400,000.00 in funding.
• Eligible applicants include: Independent school districts, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Others.

Apply for RFA NS 23 004

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