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

The "Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (FASD)" funding opportunity, offered by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), aims to advance prevention and intervention strategies for FASD across the lifespan. This initiative supports research that addresses reducing prenatal alcohol exposure and mitigating its effects through innovative and evidence-based approaches. Funded under the R61/R33 Exploratory/Developmental Phased Award mechanism, this grant facilitates initial feasibility and pilot studies (R61 phase) with the potential for expanded clinical application and evaluation (R33 phase). Transition to the R33 phase is contingent on achieving R61 milestones, and priority is given to proposals involving clinical trials. The initiative focuses on high-impact research areas such as designing cost-effective and culturally sensitive prevention strategies, developing novel interventions to address neurocognitive and behavioral deficits in individuals with FASD, and improving caregiver skills. Additional areas include school-based methods, stigma reduction, and leveraging innovative technologies to enhance health outcomes. Projects must clearly delineate the goals, milestones, and evaluation metrics for each phase. A key emphasis is placed on transitioning research findings into clinical practice, particularly for high-risk or underserved populations. The funding allows for a maximum of $350,000 in direct costs for the R61 phase (over two years) and up to $500,000 annually for the R33 phase (up to three years), with a total project period not exceeding five years. Applicants must propose milestones for the R61 phase that justify continuation to the R33 phase. These milestones are rigorously reviewed for feasibility and scientific merit. Eligible applicants include U.S. and foreign higher education institutions, non-profit organizations, for-profit organizations, and tribal entities. Applications must comply with NIH registration requirements, including SAM.gov, Grants.gov, and eRA Commons. Individuals from underrepresented groups and institutions serving these populations are encouraged to apply. Applications must be submitted electronically via Grants.gov or other NIH submission platforms, adhering to all formatting and content guidelines outlined in the NIH "How to Apply" Application Guide. A letter of intent, though optional, is recommended. Key submission deadlines are February 19, June 17, and October 17, starting in 2025, with corresponding review and award cycles. Applicants should ensure that proposals align with NIAAA’s objectives and consult NIAAA program staff for guidance on responsiveness. Review criteria emphasize the significance and innovation of the proposed research, rigor and feasibility of the approach, and the expertise and resources of the investigative team. Protections for human subjects, inclusion of diverse populations, and the generalizability of study findings are also critical evaluation factors. Successful applicants must comply with NIH data sharing policies, including submitting a Data Management and Sharing Plan. Annual progress reports, financial reports, and a final report summarizing project outcomes are required. Questions regarding this funding opportunity can be directed to NIAAA’s program staff, whose contact information is provided in the announcement.