Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required) | PAR 25 149

Opportunity Information: Apply for PAR 25 149

This funding opportunity, titled "Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)," is a National Institutes of Health (NIH) Notice of Funding Opportunity (NOFO) that is specifically designed for a narrow group of applicants: teams that already hold an active NINDS-supported U01 clinical trial cooperative agreement and need more time and added resources to finish the same clinical trial. In other words, this is not a general call for new clinical trial ideas or brand-new study starts. It is a renewal mechanism meant to help ongoing NINDS-funded trials reach completion when the original project period and budget are no longer sufficient to finalize key trial activities, such as completing enrollment, follow-up, data cleaning, analysis, and closeout steps tied to the existing protocol.

The mechanism is a cooperative agreement (U01), which generally means NIH (through NINDS, the National Institute of Neurological Disorders and Stroke) expects to have substantial scientific or programmatic involvement during the project period compared with a standard research grant. The NOFO is explicitly labeled "Clinical Trials Required," signaling that the application must involve a clinical trial and that the request should be grounded in the needs of the currently funded trial, not an observational study or a separate research project. The practical intent is to prevent promising trials from ending prematurely due to time or resource constraints and to ensure that the federal investment already made in participant recruitment, site startup, and trial conduct results in complete and interpretable outcomes.

This is a limited competition opportunity, meaning eligibility is restricted. The NOFO invites renewal applications only from existing NINDS-supported clinical trial cooperative agreement awards (U01) that require additional time and resources to complete the clinical trial. Applicants should expect that the renewal request needs to be justified by trial realities and milestones, such as slower-than-expected enrollment, extended follow-up requirements, operational disruptions, or other legitimate factors that create a gap between the current award period and what is required to finish the trial to a standard that supports clear conclusions and dissemination. Since the award is intended to support completion, a competitive application would typically focus on an updated and realistic timeline, an explanation of what remains to be done, and a detailed plan for achieving closeout-ready deliverables (for example, final database lock, final statistical analysis, regulatory reporting, and publication or results reporting expectations).

The sponsoring agency is the National Institutes of Health, and the relevant NIH institute is NINDS. The opportunity is categorized as discretionary and falls under the health funding activity category, with CFDA number 93.853. The funding opportunity number is PAR-25-149, and the NOFO record indicates a creation date of 2024-10-28. The listed original closing date is 2027-11-05, which suggests NIH plans to keep this renewal pathway open for a multi-year window, though applicants should still verify the current application due dates, any cycles, and any updates in the full NOFO text and NIH guide notices.

Eligibility information in the source data includes several applicant types, such as independent school districts, public housing authorities/Indian housing authorities, and "others," and it also explicitly lists additional eligible categories: eligible agencies of the federal government, faith-based or community-based organizations, Indian/Native American tribal governments (other than federally recognized), regional organizations, and U.S. territories or possessions. At the same time, the NOFO clearly states that non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. That restriction is important for any consortium-based trial that might otherwise rely on foreign sites or foreign subcomponents; applicants would need to ensure the proposed renewal activities align with these eligibility limits and do not depend on ineligible non-U.S. components.

Several key funding details are not provided in the excerpted source data. For example, the award ceiling and the number of expected awards are not specified here, so applicants would need to consult the full NOFO to understand typical budget ranges, allowable costs, project period limits, and how NINDS expects applicants to structure the renewal request. Because this is a renewal aimed at completion rather than expansion, the budget narrative would generally be expected to connect requested costs directly to remaining trial activities (for example, participant visits, site payments tied to completion, data management and monitoring needed for closeout, statistical analysis, and required reporting).

Overall, PAR-25-149 is best understood as a targeted continuation option for existing NINDS U01 clinical trials that are already underway and need a final, justified extension with resources to finish the job. It is not a broad clinical trial funding program, and it is not open to foreign organizations or foreign components. The core theme is completion: providing enough time and support for an ongoing NINDS-funded clinical trial to reach its planned endpoints, produce high-quality final data, and responsibly close out the study.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-10-28.
• Applicants must submit their applications by 2027-11-05.
• Eligible applicants include: Independent school districts, Public housing authorities/Indian housing authorities, Others.

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