Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and institutions investigating prevention and intervention approaches for Fetal Alcohol Spectrum Disorders (FASD). Eligible applicants include academic medical centers, research institutions, hospitals, and nonprofit research organizations with demonstrated research capacity. Applications must be led by a principal investigator with relevant research credentials in maternal health, pediatric disorders, neurodevelopmental conditions, or related fields. The program uses an R61/R33 mechanism, which offers optional clinical trial components. Domestic institutions receiving federal funding and foreign organizations applying in partnership with U.S. institutions may be eligible. Applicants must comply with NIH requirements including institutional review boards, federal assurances, and animal care standards where applicable. The grant supports both basic science investigations and clinical research aimed at understanding, preventing, or treating FASD.
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Program description
This Notice of Funding Opportunity (NOFO) focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and the incidence of FASD and that (2) interventions for FASD. These objectives will be accomplished with the Exploratory/Developmental Phased Award (R61/R33) mechanism, clinical trial optional. The R61 phase will support pilot studies or secondary data analysis for hypothesis development and feasibility, and research testing the hypotheses can be expanded in the R33 phase. The transition to the R33 phase will be determined by NIAAA program staff after evaluation of the achievement of specific milestones set for the R61 phase. Highest priority will be given to applications with clinical trials. Applicants interested in planning clinical trials or adding to current projects may also consider NOFO (TEMP-23832, the R34 option).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and supporting forms
- Project narrative (research strategy) with specific aims, background, design, and feasibility
- Detailed budget and budget narrative for Phase 1 (R61) and projected Phase 2 (R33) costs
- Biographical sketches of principal investigator and key personnel (NIH format)
- Literature cited section
- Facilities and administrative resources documentation
- Letters of support from collaborating institutions or clinical sites (if applicable)
- Human subjects protection documentation (IRB approval letter or certification of exemption)
- Data management and sharing plan
- Conflict of interest disclosures
- Institutional assurance of compliance with federal regulations (e.g., IACUC for animal studies if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.273 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$125,900,663
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$34,675,742
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$34,469,501
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$33,261,336
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$32,897,567
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$31,652,514
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$30,394,602
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$29,223,384
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$29,195,978
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$29,168,993
Top States by Funding
- CA 15 awards $242.3M
- NY 3 awards $162.6M
- OR 7 awards $96.3M
- NC 4 awards $67.1M
- IN 3 awards $57.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.273). How funding has trended year over year.
| 2024 | $430,377,419 | |
| 2025 | $429,906,735 | |
| 2026 est. | $12,401,560 |
FAQ
Who can apply for this NIH FASD grant?
Eligible applicants include academic research institutions, medical centers, hospitals, and nonprofit organizations with active research programs. The principal investigator must hold a doctorate (Ph.D., M.D., D.O., or equivalent) and demonstrate relevant research experience. Foreign institutions may apply if partnered with a U.S. organization.
What is the R61/R33 mechanism and how does it work?
The R61/R33 is a two-phase award structure. Phase 1 (R61) typically funds exploratory or feasibility work with optional clinical trial components. Phase 2 (R33) provides expanded funding if Phase 1 milestones are met. Not all applicants will progress to Phase 2 based on performance.
What types of research activities are supported?
The program supports prevention approaches (e.g., maternal interventions), early detection and diagnosis methods, intervention strategies for affected individuals, mechanistic studies, and optional clinical trials. Both basic science and translational research are appropriate.
What is the typical funding range and budget period?
Federal FASD research grants typically range from $250,000 to $2 million per year depending on scope and whether clinical trials are included. Phase 1 is usually 2 years; Phase 2 may extend an additional 3-4 years if renewed.
What are the deadlines and what should I know about competitiveness?
The fixed deadline is November 17, 2026. This is a competitive program receiving many submissions. Success typically requires strong preliminary data, experienced research teams, clear innovation, feasibility for the timeline, and alignment with NIH funding priorities in maternal-child health and neurodevelopmental disorders.
💡 Tips for applicants
- Build a strong research team with complementary expertise in maternal health, pediatric development, behavioral sciences, or clinical medicine. NIH reviewers favor multidisciplinary approaches to complex problems like FASD.
- Develop robust preliminary data demonstrating proof-of-concept. For R61/R33 submissions, Phase 1 outcomes should show clear measurable milestones that support progression to Phase 2; be explicit about go/no-go criteria.
- Clearly explain the innovation and how your approach differs from existing prevention or intervention strategies. FASD research is active; position your work as an advance rather than incremental refinement.
- Address feasibility head-on, especially if proposing clinical trials. Identify your patient population, recruitment strategy, retention plan, and realistic timelines. Underpowered or unachievable clinical work is a major reviewer concern.
- Align with NIH strategic priorities. Review recent NIH announcements on FASD, maternal health equity, and neurodevelopmental disorders. Emphasize public health impact, health disparities, and translation to clinical practice where relevant.
⚠️ Common mistakes
Applications often fail due to weak preliminary data or lack of clear mechanistic insight into how the intervention prevents or mitigates FASD symptoms. Another common issue is unrealistic timelines or budgets for clinical trials—reviewers are skeptical of studies proposing ambitious enrollment or follow-up in an underfunded Phase 1. Finally, proposals that do not clearly articulate innovation or differentiation from existing FASD prevention programs (e.g., FASD-aware prenatal counseling) struggle to score competitively.
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