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.Apply for PAR 25 149
- 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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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled: "Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)."
What is the funding opportunity number (NOFO number)?
The funding opportunity number is PAR-25-149.
Which agency and institute are sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the relevant NIH institute is the National Institute of Neurological Disorders and Stroke (NINDS).
What type of funding mechanism is used?
This opportunity uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply for NIH involvement?
A cooperative agreement (U01) generally means NIH (through NINDS) expects to have substantial scientific or programmatic involvement during the project period, compared with a standard research grant.
Is a clinical trial required under this NOFO?
Yes. The NOFO is explicitly labeled "Clinical Trials Required," meaning the application must involve a clinical trial and be tied to the currently funded trial.
Is this opportunity open to brand-new clinical trial proposals?
No. This is not a general call for new clinical trial ideas or brand-new study starts. It is a renewal mechanism intended to support completion of an existing NINDS-funded U01 clinical trial.
Who is eligible to apply?
This is a limited competition opportunity. Renewal applications are invited only from teams that already hold an active NINDS-supported U01 clinical trial cooperative agreement and need additional time and resources to complete the same clinical trial.
What does "limited competition" mean in practice?
"Limited competition" means eligibility is restricted to a narrow group: existing NINDS-supported U01 clinical trial cooperative agreement awardees seeking renewal to finish their ongoing trial.
What is the main purpose of this renewal opportunity?
The practical intent is to prevent promising ongoing trials from ending prematurely due to time or resource constraints and to ensure the federal investment already made results in complete, interpretable outcomes and responsible closeout.
What kinds of needs is this renewal intended to address?
The renewal is meant to provide more time and added resources to finish the same clinical trial when the original project period and budget are no longer sufficient for key completion activities.
What trial activities might renewal funding support?
Examples of activities tied to completion include completing enrollment, follow-up, data cleaning, analysis, and closeout steps tied to the existing protocol.
What are examples of acceptable reasons a trial may need more time or resources?
The NOFO indicates renewal requests should 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.
Does the renewal support expansion into a different study or a new protocol?
No. The request should be grounded in the needs of the currently funded trial and tied to the existing protocol, not a separate research project.
Can an observational study be proposed under this NOFO?
No. The NOFO is "Clinical Trials Required" and the application is expected to be for completion of the existing clinical trial, not an observational study.
What would a competitive renewal application typically emphasize?
A competitive application would typically focus on an updated and realistic timeline, a clear explanation of what remains to be done, and a detailed plan to achieve closeout-ready deliverables (such as final database lock, final statistical analysis, regulatory reporting, and publication or results reporting expectations).
Are foreign (non-U.S.) organizations eligible to apply?
No. The NOFO states that non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. Non-domestic components of U.S. organizations are also not eligible under this NOFO.
Why do the foreign eligibility restrictions matter for consortium trials?
This restriction can affect consortium-based trials that might rely on foreign sites or foreign subcomponents. Renewal activities must align with the eligibility limits and should not depend on ineligible non-U.S. components.
What applicant types are mentioned as eligible in the source information?
The source information lists several applicant types, including independent school districts, public housing authorities/Indian housing authorities, and "others." It also lists additional eligible categories such as 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.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.853.
How is this opportunity categorized?
It is categorized as discretionary and falls under the health funding activity category.
When was the NOFO record created?
The NOFO record indicates a creation date of 2024-10-28.
What is the listed closing date in the provided information?
The listed original closing date is 2027-11-05.
Does the listed closing date mean applicants can ignore other due dates?
No. While the excerpt suggests a multi-year window, applicants should still verify the current application due dates, any cycles, and any updates in the full NOFO text and NIH guide notices.
Are the award ceiling and number of expected awards provided in the excerpt?
No. Several key funding details are not provided in the excerpted source data, including the award ceiling and the number of expected awards.
What should applicants do to confirm budget ranges and project period limits?
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.
How should the renewal budget typically be justified?
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).
What is the central theme or focus of PAR-25-149?
The core theme is completion: providing enough time and support for an ongoing NINDS-funded U01 clinical trial to reach its planned endpoints, produce high-quality final data, and responsibly close out the study.
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