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

FAQs: NIH Discretionary Grant - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)

What is this funding opportunity?

This is a National Institutes of Health (NIH) 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).

What type of grant mechanism is it?

It uses the R34 mechanism, which is a planning grant designed to support early-stage, foundation-building activities that prepare a team for a later, larger-scale FASD prevention or intervention study.

What is the overall purpose of this NOFO?

The purpose is to strengthen the pipeline of well-prepared, rigorously planned projects that can reduce prenatal alcohol exposure and improve outcomes for individuals affected by fetal alcohol spectrum disorders (FASD) across the lifespan.

What research areas does the NOFO support?

The NOFO supports two broad directions: (1) prevention approaches to reduce alcohol use during pregnancy and lower the incidence of FASD, and (2) intervention research to improve health, functioning, and quality of life for people with FASD and for their families, caregivers, and communities.

Is this grant intended to fund a full-scale clinical trial or large effectiveness study?

No. As a planning grant, the R34 is not primarily intended to fund a full definitive trial or a large effectiveness study from start to finish. It is meant to fund the planning and preparatory work that positions a later, larger application for success.

What kinds of activities are typically supported under an R34 planning grant for this topic?

R34 projects commonly support preparatory activities such as refining an intervention protocol, developing recruitment and retention strategies, establishing partnerships with clinical or community sites, confirming feasibility and acceptability of procedures, piloting outcome measures, building data and safety monitoring plans, and completing other steps that reduce risk before scaling up.

Are clinical trials required under this opportunity?

No. Clinical trials are optional, which means applicants may propose trial-related planning work or non-trial preparatory studies, as long as the work clearly sets the stage for a later, larger project.

What does "Clinical Trial Optional" mean in practical terms?

It signals flexibility: a project can include planning for a future clinical trial (or limited trial-related preparatory work) or focus on non-trial planning and development activities, provided the proposed work is clearly aimed at enabling a subsequent larger prevention or intervention study.

Who is the intended beneficiary or target population for the research?

The NOFO is focused on preventing prenatal alcohol exposure and supporting individuals affected by FASD. Intervention work can also involve families, caregivers, and communities, reflecting the broader support systems that influence outcomes over time.

Does the NOFO encourage work across different ages or life stages?

Yes. Because FASD affects individuals across the entire lifespan and can impact multiple domains (including cognition, behavior, learning, adaptive functioning, and physical and mental health), the NOFO encourages strategies relevant at different developmental stages and in real-world settings.

Why is this opportunity described as "foundation-building"?

The R34 is intended to help teams do the critical up-front work that makes a future, larger-scale study more rigorous and feasible. The emphasis is on preparation and risk reduction before scaling up.

How does this R34 relate to a future, larger NIH application?

The expectation is that work supported under this R34 will be a prerequisite or strong stepping-stone toward a subsequent, larger application, such as a full-scale evaluation of an FASD prevention program or a larger intervention study.

Is there an alternative NIH pathway mentioned for projects that need a phased approach?

Yes. The announcement references an alternative pathway: the R61/R33 option (TEMP-23833), which is typically used for milestone-driven, phased projects that transition from an early exploratory phase to a later expanded phase.

When might an applicant consider the R61/R33 option instead of the R34?

An applicant might consider R61/R33 when the project does not fit a planning-only structure and instead benefits from a staged model with defined go/no-go milestones that guide progression from an exploratory phase to an expanded phase.

Who is eligible to apply for this NIH opportunity?

Eligibility is broad and includes many organization types, reflecting the cross-sector nature of FASD prevention and intervention efforts.

Are government entities eligible applicants?

Yes. Eligible government applicants include state, county, city or township governments, special district governments, and independent school districts.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.

Are tribal governments and tribal organizations eligible?

Yes. Eligibility explicitly includes federally recognized Native American tribal governments, Native American tribal organizations that are not federally recognized, and Indian/Native American tribal governments other than federally recognized entities.

Are nonprofits eligible to apply?

Yes. Nonprofits with and without 501(c)(3) status are eligible, as long as they are not institutions of higher education.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.

Are housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are explicitly listed as eligible applicants.

Are faith-based and community-based organizations eligible?

Yes. The opportunity explicitly includes faith-based or community-based organizations among eligible applicants.

Are minority-serving institutions specifically called out as eligible?

Yes. The eligibility list explicitly includes 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), and Tribally Controlled Colleges and Universities (TCCUs).

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are listed as eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly included as eligible applicants.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The opportunity explicitly states that non-U.S. entities (foreign organizations) are eligible.

Is the NOFO designed for collaboration across sectors and real-world settings?

Yes. The NOFO reflects that FASD prevention and intervention often require cross-sector collaboration, including health systems, schools, social services, tribal and community organizations, and international partners.

What is the deadline for this opportunity?

The closing date listed for this opportunity is January 7, 2027.

What is the Funding Opportunity Number and CFDA listing?

The Funding Opportunity Number is PAR 25 159, and the CFDA listing provided is 93.273.

Who is this R34 opportunity best suited for?

It is best suited for teams with a promising FASD prevention or intervention idea that need focused support to complete critical preparatory work, making a subsequent full-scale application more competitive and more likely to succeed.