NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) | PAR 21 237

Opportunity Information: Apply for PAR 21 237

The NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) funding opportunity (PAR-21-237) is a National Institutes of Health (NIH) cooperative agreement designed to support investigator-initiated efficacy clinical trials that align with the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). In plain terms, it is meant for research teams that are ready to test whether an intervention works in people for neurological disorders or stroke-related conditions, using a well-designed clinical trial. NINDS is looking for trials that answer meaningful clinical questions within its scientific scope, and it explicitly allows a wide range of intervention types, including drugs, biologics, and medical devices, as well as surgical approaches, behavioral treatments, and rehabilitation therapies. Applicants are expected to ensure their proposed study fits clearly within NINDS program interests, which are described on the institute's website.

This opportunity uses the UG3/UH3 phased award structure under a cooperative agreement, which typically means the project is supported in two linked stages with active involvement from NIH staff. The UG3 phase generally supports planning and start-up activities needed to responsibly launch an efficacy trial, while the UH3 phase supports implementation once predefined milestones are met. Because this is a cooperative agreement rather than a standard grant, awardees should expect substantial NIH programmatic involvement, such as coordinated oversight, milestone-driven progression, and ongoing communication around trial conduct, performance, and alignment with the approved plan.

The FOA sits in the health funding category and is associated with CFDA number 93.853. It is classified as a discretionary funding opportunity and supports clinical trials that are explicitly required, meaning the application must include a clinical trial that evaluates efficacy. While the posted source data does not list an award ceiling or the expected number of awards, applicants should not interpret that as unlimited funding; instead, budgets are typically evaluated based on the scientific justification, the operational needs of the trial, and NINDS policies and expectations for cost realism.

Eligibility is broad and includes many types of U.S. governmental entities and research-performing organizations. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public housing authorities and Indian housing authorities; and federally recognized Native American tribal governments. Academic eligibility includes public and state-controlled institutions of higher education as well as private institutions of higher education. The FOA also allows nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education when specified), for-profit organizations other than small businesses, and small businesses. In addition, the announcement highlights categories of other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). That breadth signals NINDS interest in strong trials regardless of institutional type, as long as the team can meet clinical trial and regulatory expectations and can carry out the work successfully.

Key timing details from the source data include an original closing date of 2025-01-09 and a creation date of 2021-05-19. Prospective applicants should still verify current submission dates and any updates or reissues of the FOA in NIH systems before preparing an application, since NIH opportunities can have multiple receipt dates, amendments, or policy updates over time.

Overall, this FOA is aimed at research groups prepared to run a rigorous, milestone-driven efficacy trial in neurology or stroke, with NINDS closely engaged through the cooperative agreement mechanism. The central expectation is a trial that can credibly determine whether a treatment or intervention provides clinical benefit, using methods appropriate for the question, population, and intervention type, and with the operational readiness to move from structured start-up to full trial execution under the UG3/UH3 framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial 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 2021-05-19.
• Applicants must submit their applications by 2025-01-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 PAR 21 237

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