Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional) | PAR 25 158

Opportunity Information: Apply for PAR 25 158

The National Institutes of Health, through the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is soliciting research applications under the grant opportunity titled "Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)" (Funding Opportunity Number PAR-25-158; CFDA 93.273). The central goal is to move the field forward on practical, evidence-driven ways to prevent fetal alcohol spectrum disorders (FASD) and to improve outcomes for people living with FASD across the full lifespan. The NOFO emphasizes two broad areas: first, prevention strategies that reduce prenatal alcohol exposure and ultimately lower the incidence of FASD; and second, interventions that address the needs of individuals with FASD, which can include approaches that target health, development, behavior, learning, functioning, and quality of life.

This opportunity uses the Exploratory/Developmental Phased Award mechanism (R61/R33), which is designed to support a staged pathway from early development into larger-scale testing. The R61 phase supports early work such as pilot studies and feasibility testing, as well as secondary data analysis that helps generate or refine hypotheses and confirm whether an approach is workable, acceptable, and ready for more rigorous evaluation. If the project meets clearly defined milestones established for the R61 phase, NIAAA program staff may approve a transition into the R33 phase, where the research can expand into more definitive hypothesis testing. In other words, the application should not treat the R61 and R33 as two separate grants; it should present a coherent plan where early-phase activities produce specific deliverables that justify a larger next step.

While clinical trials are optional under this NOFO, NIAAA indicates that the highest priority will be given to applications that include clinical trials. This suggests the program is especially interested in projects that can directly test prevention or intervention strategies in real-world or clinical settings, rather than stopping at conceptual development alone. For applicants who are earlier in the process and primarily need planning support for a clinical trial, or who want to add a clinical trial component to an existing line of work, the announcement points to another option: an R34 planning mechanism referenced as TEMP-23832.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights additional 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 foreign (non-U.S.) entities.

Key administrative details include that this is a discretionary NIH grant opportunity in the health activity category. The opportunity was created on 2024-11-25, and the listed original closing date is 2026-11-17. The posted materials do not specify an award ceiling or the expected number of awards in the provided excerpt, so applicants would need to consult the full announcement and NIH budget guidance for any limits, typical budget ranges, project period expectations, and institute-specific considerations.

In practical terms, a strong application is likely to be one that defines a meaningful prevention or intervention problem in FASD, proposes an approach that can be realistically implemented and evaluated, lays out measurable R61 milestones that reduce risk before scaling, and then provides a clear, methodologically sound plan for the R33 phase that can produce interpretable results. Because NIAAA will decide on the R61-to-R33 transition based on milestone achievement, the application needs to be very specific about what success looks like in the early phase and how those results will trigger the larger study.

• 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 (R61/R33 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 2026-11-17. (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.

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