Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)

The Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional) is a federal funding initiative spearheaded by the National Institutes of Health (NIH) in collaboration with the U.S. Food and Drug Administration (FDA). Administered through the NIH's Tobacco Regulatory Science Program (TRSP), the funding opportunity is intended to support early-career biomedical, behavioral, and social science researchers who are beginning independent careers in tobacco regulatory research. The initiative is rooted in a broader interagency effort to generate scientific evidence that informs FDA regulation of tobacco product manufacturing, distribution, and marketing under the authority of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. This grant program uses the R03 Small Grant mechanism, which supports discrete, well-defined projects with a limited scope and short duration. Types of research funded include pilot and feasibility studies, secondary data analyses, self-contained research projects, development of research methodology, and new technology. Applicants must focus on research that falls under FDA Center for Tobacco Products (CTP) regulatory authority and aligns with one or more designated High-Priority Research Topics. These topics include addiction, behavior, health effects, product composition and design, and toxicity as they pertain specifically to electronic nicotine delivery systems (ENDS), nicotine pouches, and other identified tobacco products. Studies must not stray into non-responsive areas, such as tobacco communication campaigns, marketing influence, or mechanistic disease research outside the scope of predictive harm biomarkers. Funding for this opportunity is limited to $75,000 in direct costs per year, with a maximum project period of two years. A total of up to four awards are anticipated for FY2026, with up to $500,000 available. The application process does not require cost sharing, and only new investigators—those who have not previously received independent NIH funding—are eligible. Specifically excluded are researchers who have received R01s, previous FDA-funded R03 or R21 awards, or those in the R00 phase of a Pathway to Independence Award from FDA CTP. Eligible applicant institutions include a wide range of U.S.-based organizations such as higher education institutions, nonprofits, state and local governments, tribal entities, and small businesses. Foreign institutions and components are not eligible. The submission process includes an optional but encouraged Letter of Intent, due 60 days before the application due date. Applications must be submitted electronically via the NIH ASSIST system, Grants.gov Workspace, or institutional system-to-system platforms. Key dates for application submission are November 18, 2025, and July 14, 2026, with corresponding review cycles leading to possible award start dates in July 2026 and April 2027, respectively. All applications are due by 5:00 PM local time on the date of submission, and late applications will not be accepted. Applications will be evaluated based on three core factors: importance of the research (significance and innovation), rigor and feasibility (approach), and expertise and resources (investigators and environment). Applications must demonstrate scientific relevance to FDA CTP's regulatory mandate and align with listed High-Priority Research Topics. Administrative contacts are available at NIH’s NCI, NHLBI, and NIDA, with specific personnel designated for both scientific and grants management inquiries. Researchers are encouraged to contact these representatives for guidance on project responsiveness and eligibility. Other notable requirements include adherence to data sharing policies, use of standard measures from the PhenX Toolkit for human subjects research, and transparency regarding any affiliations with the tobacco industry. Applications that do not conform to all specified guidelines may be considered non-responsive and not reviewed. This funding opportunity offers new investigators a chance to contribute directly to public health-oriented regulatory science by supporting FDA’s mission to reduce tobacco-related harm.

Investigators are strongly encouraged to contact the Scientific/Research Contacts before submitting applications to ensure responsiveness to the NOFO.