RFA-OD-25-008
Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)
Summary
Tobacco Regulatory Science Small Grant Program for New Investigators (R03)
Research Focus
This program supports early-career researchers establishing independent careers in tobacco regulatory science. The R03 mechanism funds pilot and feasibility studies, secondary data analysis, small self-contained projects, research methodology development, and new research technology—all designed to generate preliminary evidence informing FDA regulation of tobacco products under the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Research must address high-priority topics within FDA's Center for Tobacco Products regulatory authority. Priority areas include: addiction liability and nicotine pharmacokinetics of electronic nicotine delivery systems (ENDS) and nicotine pouches; behavioral effects of ENDS, heated tobacco products, and emerging products across youth and adult populations; human health effects of ENDS (cardiovascular, pulmonary, neurological); chemical and microbial composition of tobacco products; and toxicity of ENDS through in vitro, in vivo, in silico, or aerosol testing approaches. Research on populations experiencing tobacco-related disparities is encouraged where relevant.
At-a-Glance
- Who can apply: New Investigators and Early-Stage Investigators in biomedical, behavioral, or social sciences with no prior independent NIH tobacco regulatory science funding
- Funding & project length: Not stated; R03 mechanism typically supports 2-year projects with limited budgets
- Award mechanism: R03 Small Grant (clinical trial optional)
- Key dates: Applications due November 18, 2025 (earliest cycle); program expires July 15, 2026
- Best fit for: Tobacco researchers (addiction, behavior, toxicology, product chemistry) conducting preliminary studies on ENDS, nicotine pouches, or heated tobacco products in human subjects or alternative toxicology models
Key Facts
Deadline
Tue, July 14, 2026
Posted
Tue, June 24, 2025
Award / Year (direct costs)
$100,000
Max Total
$200,000
Max Duration
2 years
Keywords
Research Areas
Gotchas (6)
New Investigators must not have received ANY prior grant to support research in tobacco regulatory science, which is a stricter definition than typical NIH 'new investigator' status
95%
Source Text
“support New Investigators (including Early-Stage Investigators and investigators who have not successfully competed for independent NIH funding) in the biomedical, behavioral, and social sciences who are in the early stages of establishing independent careers in tobacco regulatory science but have not yet received any grant to support research in tobacco regulatory science”
Applications addressing health effects of ENDS must be limited to human subjects only (not animal models), which is an explicit restriction on study design
95%
Source Text
“Understanding the health effects of ENDS in human subjects. Applications addressing health effects must address the high-priority research topic below: Impact of ENDS use on human health, limited to cardiovascular effects, pulmonary effects, or neurological effects, including acute and/or chronic health outcomes in human subjects (i.e., not animal models).”
Addiction research applications MUST focus on ENDS and/or nicotine pouches AND address specific sub-topics; applications on other tobacco products or addiction mechanisms may be non-responsive
95%
Source Text
“Understanding the effect of tobacco product characteristics* of ENDS and/or nicotine pouches on addiction and/or abuse liability across populations. Applications addressing addiction must (1) focus on ENDS and/or nicotine pouches AND (2) address one or more of the high-priority research topics below”
Toxicity research applications MUST focus on ENDS and/or their characteristics AND address the specific benchmark concentration/point of departure requirement for ethyl maltol and/or maltol
95%
Source Text
“Understanding how ENDS and/or changes to ENDS characteristics* affect their potential to cause morbidity and/or mortality in users through direct exposure and/or in nonusers through secondary exposure. These could include cell culture (in vitro) models, animal (in vivo) approaches, computational (in silico) methods, and/or other alternative toxicology approaches, and/or studies that test the toxicity of ENDS aerosols (e.g., aldehydes, metals), or specific constituents (e.g., aldehydes, metals) i”
Only High-Priority Research Topics explicitly listed in the NOFO will be deemed responsive; any deviation may result in non-responsive determination
95%
Source Text
“Projects must propose research aims that are within the regulatory authority of FDA CTP and the High-Priority Research Topics identified in this NOFO in order to be considered responsive to this NOFO. Only High-Priority Research Topics listed above will be deemed responsive.”
Pre-application consultation with Scientific/Research Contact is strongly encouraged before submitting Letter of Intent and/or application to verify responsiveness to NOFO
85%
Source Text
“investigators are strongly encouraged to discuss whether their application is responsive to this NOFO with a Scientific/Research Contact listed in Section VII before submitting their Letter of Intent and/or application and to review the Frequently Asked Questions document”