The High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional) grant is offered by the National Institutes of Health (NIH) in collaboration with the FDA Center for Tobacco Products (CTP). It aims to generate data to inform regulatory decisions that protect public health under the Family Smoking Prevention and Tobacco Control Act. Applications must address specific high-priority research topics and include a Plan for Enhancing Diverse Perspectives (PEDP).

Projects should focus on the effects of tobacco product characteristics on addiction, behavior, health, composition, or toxicity. Examples include studies on ENDS (e-cigarettes, vapes), nicotine pouches, and other emerging tobacco products. Research may examine the pharmacokinetics and pharmacodynamics of nicotine, behavioral responses to product use, cardiovascular or neurological health impacts, chemical constituents, or toxicological risks. The inclusion of populations experiencing tobacco-related disparities, such as youth, minorities, or those with mental health conditions, is encouraged.

The grant will provide up to $4 million in total funding for up to five projects, each limited to $500,000 in direct costs annually. Projects may span a maximum of five years. Both domestic and foreign institutions, including higher education institutions, nonprofits, for-profits, and other eligible entities, may apply. Applications must align with FDA CTP’s regulatory priorities, and those addressing non-priority topics will not be reviewed.

Applications must comply with detailed submission requirements, including adherence to page limits, data-sharing plans, and NIH guidelines. The required PEDP should outline strategies to enhance inclusivity in the research process, such as partnerships with diverse institutions, inclusive recruitment plans, and community engagement. Incomplete applications or those lacking a PEDP will be administratively withdrawn.

Applications are due by June 6, 2025, with the earliest start date in April 2026. Applicants must ensure proper registrations, including in SAM.gov and eRA Commons, and are advised to submit letters of intent 60 days before the due date. Additional guidance is available in the NOFO and related NIH resources.