Notice of Intent to Publish a Notice of Funding Opportunity (NOFO) for High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA) Center for Tobacco Products, plans to publish a Notice of Funding Opportunity (NOFO) for high-priority research in tobacco regulatory science. This opportunity, identified under NOFO number NOT-OD-25-002, seeks applications for new biomedical and behavioral research that provides essential data to inform and support the regulation of tobacco products, with the ultimate goal of protecting public health. Scheduled to be officially published in December 2024, this funding announcement will allow a single application cycle, with submission due in June 2025. It is structured under NIH’s R01 funding mechanism, which supports comprehensive, independent research projects, and will accommodate optional clinical trials. The NOFO emphasizes research that aligns with federal priorities on tobacco control and regulatory science, covering areas such as tobacco use behaviors, toxicity of tobacco products, addiction, health effects of exposure to tobacco constituents, and potential risks and benefits of reduced-risk tobacco products. This funding will also incorporate NIH’s new simplified peer review framework (SRF) and a Plan for Enhancing Diverse Perspectives, indicating a strong commitment to fostering inclusivity in research perspectives and collaboration. Interested researchers are encouraged to begin developing partnerships and collaborations in preparation for the NOFO’s publication, as only new applications are eligible. A total of $4 million is expected to be available for this program, with up to five awards anticipated. Individual award ceilings will be capped at $500,000, with no minimum award amount specified. This funding does not require cost-sharing or matching contributions, allowing eligible applicants more financial flexibility to design research proposals that meet program goals. Projects approved for funding are expected to begin by April 2026, with awards allocated through a discretionary grant process. Eligible applicants include a wide range of organizations, from public and state-controlled institutions of higher education, nonprofits with 501(c)(3) status, and independent school districts to Native American tribal organizations, both federally recognized and otherwise. State and county governments, public housing authorities, as well as private higher education institutions and for-profit organizations (excluding small businesses) are also eligible. This broad eligibility encourages diverse participation and collaboration across sectors to address high-priority research areas in tobacco regulation. The program’s intended focus on regulatory science research underscores the NIH and FDA's commitment to advancing knowledge that can directly impact public policy and health guidelines regarding tobacco. Research outcomes from this initiative are expected to contribute to a robust evidence base to inform federal regulation efforts, supporting healthier communities through scientifically-backed regulatory decisions. The specific objectives, evaluation criteria, and review processes will be provided in the upcoming NOFO release in Winter 2024. Researchers interested in this opportunity are advised to closely monitor updates from the NIH and FDA Tobacco Regulatory Science Program (TRSP) and plan projects aligned with federal tobacco regulation priorities. This preparation phase offers time for developing research designs and establishing cross-institutional or interdisciplinary collaborations that may enhance the competitiveness of applications.