Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional) | PAR 25 159

Opportunity Information: Apply for PAR 25 159

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)" under Funding Opportunity Number PAR 25 159 (CFDA 93.273). This is an R34 planning grant, meaning it is designed to support early-stage, foundation-building work that helps researchers get ready for a future, larger-scale prevention or intervention study focused on fetal alcohol spectrum disorders (FASD). The closing date listed for this opportunity is January 7, 2027.

The overall purpose of the NOFO is to strengthen the pipeline of well-prepared, rigorously planned projects that can meaningfully reduce prenatal alcohol exposure and improve outcomes for individuals affected by FASD across the entire lifespan. The funding is aimed at two broad research directions. First, it supports prevention approaches that seek to reduce alcohol use during pregnancy and, as a result, lower the incidence of FASD. Second, it supports intervention research intended to help people with FASD and their families, caregivers, and communities by improving health, functioning, and quality of life over time. Because FASD can affect multiple domains (such as cognition, behavior, learning, adaptive functioning, and physical and mental health), the NOFO is positioned to encourage strategies that are relevant at different developmental stages and in real-world settings.

As a planning grant mechanism, the R34 is not primarily meant to fund a full definitive trial or a large effectiveness study from start to finish. Instead, the expectation is that the work supported here will be a prerequisite for a subsequent, larger application, such as a full-scale FASD prevention program evaluation or an intervention study. In practical terms, R34 projects commonly focus on activities like refining an intervention protocol, developing recruitment and retention strategies for the target population, establishing partnerships with clinical or community sites, confirming the feasibility and acceptability of procedures, piloting outcome measures, building data and safety monitoring plans, and completing other key steps that reduce risk before scaling up. The NOFO also notes that clinical trials are optional, which signals that applicants can propose either trial-related planning work or non-trial preparatory studies, as long as the work clearly sets the stage for a later, larger project.

The announcement also points out an alternative pathway for applicants who want an exploratory phased approach: the R61/R33 option referenced as TEMP-23833. That alternative is typically considered when a project benefits from a milestone-driven, phased structure that transitions from an early exploratory phase to a later expanded phase. The inclusion of this note is basically guidance for teams whose research plan may not fit the planning-only nature of an R34 and instead needs a staged model with defined go/no-go milestones.

Eligibility is broad and includes many types of organizations that can contribute to FASD prevention and intervention research. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. Tribal eligibility is explicitly inclusive, covering federally recognized Native American tribal governments and also Native American tribal organizations that are not federally recognized, along with Indian/Native American tribal governments other than federally recognized entities. The NOFO also welcomes public housing authorities and Indian housing authorities, nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses. Beyond the standard categories, the opportunity explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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). This wide eligibility reflects the reality that FASD prevention and intervention efforts often require cross-sector collaboration, including health systems, schools, social services, tribal and community organizations, and international partners.

In short, this NIH R34 NOFO is aimed at building strong, actionable plans and preliminary evidence for future larger studies that either prevent prenatal alcohol exposure and reduce new cases of FASD or improve interventions for individuals living with FASD throughout life. It is best suited for teams that have a promising prevention or intervention idea but need focused support to complete the critical preparatory work that will make a subsequent full-scale application more competitive and more likely to succeed.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2024-11-25.
• Applicants must submit their applications by 2027-01-07.
• 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 25 159

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