Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)
Open Posted
- Opportunity number
- PAR-25-149
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Public or Indian Housing Auth.
- Other
- Independent School Districts
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health seeks renewal applications for existing NINDS-supported clinical trial cooperative agreement awards (U01) requiring additional time and resources to complete the clinical trial, with applications due November 5, 2027. This limited competition is restricted to incumbent award recipients only.
Eligible applicants include public or Indian housing authorities, independent school districts, eligible federal agencies, faith-based or community-based organizations, Indian and Native American tribal governments (other than federally recognized), regional organizations, and U.S. territories or possessions. Non-domestic entities and non-domestic components of U.S. organizations are ineligible.
The cooperative agreement structure supports completion of existing NINDS-funded clinical trials. Applicants must follow NIH Research Instructions for FORMS-I applications and review both the NOFO and application instructions to determine required forms. Applications requesting $500,000 or more in direct costs in any annual budget period require prior approval from NINDS before submission.
Scientific merit evaluation focuses on significance of proposed study objectives, technical adequacy of experimental design, competency of the investigator or group, adequacy of facilities and resources, appropriateness of the budget, and relevance to NINDS program objectives. Initial review occurs through technical panels composed of scientific authorities; approved applications then compete on merit basis for available funds through the National Advisory Neurological Disorders and Stroke Council.
The funding program (CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders) manages approximately 43,429 awards totaling $44.21 billion, with cooperative agreements comprising roughly 2 percent of awards. Recent activity shows 920 awards in 2024, 748 in 2025, and 441 through mid-2026. Award recipients must adhere to standard NIH record retention (three years from annual financial status report submission) and audit requirements based on federal expenditure thresholds.
Synopsis
This limited competition Notice of Funding Opportunity (NOFO) invites renewal applications of existing NINDS-supported clinical trial cooperative agreement awards (U01) requiring additional time and resources to complete the clinical trial.
Eligibility
Other Eligible Applicants include the following: Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-149-Full-Announcement.html | HTML file | |
| PKG00288430.pdf |
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