NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required) | PAR 27 065

Opportunity Information: Apply for PAR 27 065

The NINDS Efficacy and Exploratory Clinical Trials funding opportunity (PAR-27-065) is a National Institutes of Health (NIH) Notice of Funding Opportunity designed to support investigator-initiated clinical trials that align with the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). It uses a cooperative agreement mechanism (UG3/UH3), which generally means NINDS staff will have substantial scientific and programmatic involvement during the life of the award compared with a standard grant. A clinical trial is required under this announcement, and applicants are expected to propose studies that generate actionable evidence about interventions for neurological conditions.

The scope is intentionally broad in terms of the kinds of interventions NINDS is willing to consider. Proposed trials may evaluate small-molecule drugs, biologics, medical devices, and a wide range of non-pharmacologic approaches, including surgical procedures, behavioral interventions, diet-based therapies, and rehabilitation strategies. NINDS also emphasizes neurological diseases and care across the lifespan, so studies involving pediatric, adult, and older adult populations, as well as cross-cutting issues in neurological care, are explicitly encouraged. In practical terms, this NOFO is meant to cover a large share of clinically focused neurology research, as long as the trial question fits within NINDS interests and is well-justified clinically and scientifically.

This opportunity welcomes multiple stages of clinical testing rather than restricting applicants to a single phase. It explicitly invites early- and middle-phase exploratory trials as well as later-stage confirmatory Phase 3 trials and comparative effectiveness studies. That means an applicant could propose work aimed at determining whether an intervention shows a signal of efficacy and is feasible to deliver in the intended population, or could propose a larger, more definitive study intended to confirm benefit, compare interventions head-to-head, or inform real-world clinical decision-making. The inclusion of comparative effectiveness highlights interest in trials that may compare two active approaches or test how an intervention performs relative to standard care, which can be particularly important for translating findings into clinical practice.

Eligibility is broad and includes many common applicant types across government, academia, and the private and nonprofit sectors. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. This wide eligibility reflects the reality that clinical trials in neurology can be led by universities and hospitals, but also by foundations, companies developing therapeutics or devices, and other research-capable organizations.

International participation is allowed, but it comes with a major compliance constraint that applicants need to plan for early. Non-U.S. entities (foreign organizations) may apply directly, and foreign components of U.S. organizations are allowed as defined in the NIH Grants Policy Statement. However, NIH policy described in the announcement states that NIH will no longer issue awards to domestic or foreign prime recipients if the project includes foreign subawards or subcontracts. Any application that includes foreign subawards/subcontracts under this NOFO will be considered noncompliant and will not be funded. Importantly, this restriction does not eliminate all forms of international involvement: unfunded collaborations can still occur, foreign consultants can be paid, and applicants can procure unique equipment or supplies from foreign vendors. The key issue is avoiding a funded foreign subaward/subcontract arrangement unless applying under a NOFO specifically designated for funded international collaborations.

From an administrative standpoint, the opportunity is categorized as discretionary funding, with a health activity focus and CFDA number 93.853. The sponsoring agency is the National Institutes of Health. The posting indicates an original closing date of March 9, 2029, signaling that this NOFO is expected to remain active for multiple receipt cycles over several years (applicants should still verify the specific due dates and cycles in the full NOFO). The award ceiling and expected number of awards are not specified in the provided summary, which is common for some NIH announcements and typically means budgets and award counts depend on scientific merit, program priorities, and available funds.

Overall, the NOFO is aimed at moving neurological interventions forward through well-designed clinical trials, ranging from exploratory studies that de-risk an approach to larger trials that can change practice. It supports a wide set of intervention types and populations, encourages lifespan-relevant neurology research, and permits international components while strictly prohibiting funded foreign subawards/subcontracts under this particular announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Efficacy and Exploratory 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 2026-08-31.
• Applicants must submit their applications by 2029-03-09.
• 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 27 065

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