Tobacco Regulatory Science (R01 Clinical Trial Optional)

The NIH is offering funding through the Tobacco Regulatory Science (R01 Clinical Trial Optional) grant (RFA-OD-23-017) to support research that provides scientific data to guide FDA regulation of tobacco products. Funded by the FDA Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act, this grant aims to advance knowledge on the health impacts of tobacco, especially through research that informs the FDA's authority over tobacco product manufacturing, distribution, and marketing. Eligible projects should align with the FDA CTP’s regulatory priorities, including studies on the health effects of tobacco, patterns of use, and the impact of tobacco marketing. Biomedical and behavioral research approaches are encouraged, with results expected to contribute directly to evidence-based tobacco regulation aimed at protecting public health. The program allows flexibility for clinical trials, making it open to projects involving human participants where appropriate. This opportunity has an award ceiling of $500,000 per year and does not require cost-sharing. Eligible applicants include a wide range of organizations such as nonprofits, educational institutions, state and local governments, tribal entities, small businesses, and foreign institutions. Additional eligible groups include minority-serving institutions such as HBCUs and Hispanic-serving institutions, as well as community-based organizations and non-U.S. entities. Applications are due by May 4, 2025, with awards to be administered by the NIH. Detailed information, including submission instructions, can be found on the NIH grants website.