Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 14, 2026
Can you apply?
This grant is for new investigators conducting regulatory science research on tobacco products. Applicants must be researchers affiliated with eligible institutions (universities, research hospitals, nonprofits). PIs should be within 10 years of their first independent research position or hold junior faculty status. The program prioritizes research addressing tobacco regulatory questions and public health impacts. Both domestic and international institutions may qualify if they have U.S. NIH research capacity.
Research may include clinical trials but is not required. Projects must align with FDA tobacco regulatory priorities and tobacco control science. Studies examining product characteristics, user behavior, policy impact, or health effects are eligible. The R03 mechanism typically funds preliminary/pilot data to support future larger grants.
Not the right fit? Find grants for your organization in 5 questions →
Program description
This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.
The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Application Form
- Project Narrative/Research Strategy
- Biographical Sketch (NIH format, 5 pages max per person)
- Budget & Budget Justification
- Vertebrate Animals section (if applicable)
- Human Subjects Protection documentation (if applicable)
- Letters of Support/Collaboration
- Institutional Endorsement
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.077 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$146,492,149
-
$145,109,194
-
$109,281,102
-
$102,364,379
-
$68,162,976
-
$65,213,274
-
$64,729,661
-
$62,073,883
-
$37,389,949
-
$33,837,036
Top States by Funding
- NC 8 awards $235.8M
- CA 12 awards $232.7M
- PA 7 awards $146.2M
- MI 2 awards $133.3M
- TX 5 awards $90.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.077). How funding has trended year over year.
| 2018 | $79,945,805 | |
| 2019 | $74,249,587 | |
| 2020 | $80,381,664 | |
| 2021 | $73,775,874 | |
| 2022 | $67,279,619 | |
| 2023 | $59,273,409 | |
| 2024 est. | $59,070,436 | |
| 2025 est. | $54,000,000 |
FAQ
Who qualifies as a "new investigator" for this grant?
Typically researchers within 10 years of first independent position or in early tenure-track roles. Check current NIH definition as eligibility may vary slightly by fiscal year.
Do I need to have preliminary data before applying?
Yes, you'll typically need preliminary findings supporting your proposed research. This strengthens competitiveness and demonstrates feasibility.
Can international researchers apply?
Foreign institutions may apply but the applicant organization must have significant U.S. research capacity and NIH experience. Direct contact with program staff is recommended.
What's the typical funding range for R03 grants?
R03 mechanisms typically fund $50,000-$150,000 in direct costs. Actual amounts vary by program and fiscal year.
How competitive is this program?
NIH tobacco regulatory science grants are moderately competitive. Strong preliminary data, clear research questions, and regulatory relevance significantly improve success rates.
💡 Tips for applicants
- Clearly connect your research to FDA tobacco regulatory questions and public health impact. Show why this matters for policy.
- Build your application on solid preliminary data. Budget 5-10% of funding for feasibility studies if needed.
- Engage with NIH program staff early. They can clarify regulatory science priorities and provide informal feedback.
- Be specific about tobacco product types studied. Generic tobacco research may not align with regulatory science focus.
- Present realistic timelines and milestones. R03 projects run 1-2 years, so scope accordingly.
⚠️ Common mistakes
Applications lack clear connection to FDA regulatory questions and focus only on basic tobacco science. Insufficient preliminary data or overly ambitious scope for the R03 mechanism undermines competitiveness. Poor alignment with current NIH/FDA tobacco research priorities reduces reviewer enthusiasm.
Similar grants
- CLOSED High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional) — National Institutes of Health
- OPEN NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Tobacco Centers of Regulatory Science (TCORS) (Clinical Trial Optional) — National Institutes of Health
- OPEN NICHD Small Research Grant Program (R03 Clinical Trial Required) — National Institutes of Health
- OPEN Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required) — National Institutes of Health