High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for research organizations seeking NIH funding to conduct tobacco regulatory science research. Eligible applicants typically include academic institutions, research centers, nonprofits, and other entities with research capacity. The research must be within FDA's tobacco regulatory authority and address at least one priority topic: Addiction, Behavior, Communications, Health Effects, Product Composition and Design, or Toxicity. Projects may include clinical trials but they are optional. Specific institution types (e.g., 501(c)(3), HBCUs, minority-serving institutions) may receive administrative preference through standard NIH policies.
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Key dates
- Sep 9, 2025 Applications open
- May 4, 2026 Application deadline
- Dec 4, 2026 Award announced
- Dec 4, 2026 Project start
Program description
The Tobacco Regulatory Science Program, participating NIH Institutes and Centers (ICs), and the United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to issue a Notice of Funding Opportunity (NOFO) soliciting applications for High-Priority Research Projects in Tobacco Regulatory Science (Clinical Trial Optional).
The FDA and NIH share an interest in supporting research that could inform FDA’s tobacco regulatory authorities. High-priority research encouraged by this NOFO is expected to provide additional scientific data to the research base to inform the regulation of tobacco products to protect public health. Although a vast and sound science base exists related to the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31, the NOFO will seek high-priority research that will provide additional science for the FDA to consider as it implements the FSPTCA.
In order to be considered responsive, research must (1) be within the regulatory authority of FDA CTP, (2) address one or more of the following topics: Addiction, Behavior, Communications, Health Effects, Product Composition and Design, and/or Toxicity; and (3) address all components within the subtopic(s) of the selected topic(s).
Awards will be administered by NIH using funds made available through FDA CTP and the FSPTCA. TRSP is authorized to forecast this opportunity under The Public Health Service Act and the FSPTCA, Public Law 111-31, 42 US Code 300u-3.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form
- Project Narrative (check NOFO for page limit)
- Budget and Budget Justification
- Biographical sketches of key personnel
- Letters of support
- NIH inclusion enrollment reporting forms
Program contact
- 👤 Erik Rodriquez, Ph.D., M.P.H.
- 📧 TRSP@nih.gov
- 📞 301-827-2830
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 is eligible to apply?
Academic institutions, research centers, nonprofits, and other research organizations can apply. Check NIH's general eligibility rules for your organization type.
When is the deadline?
The deadline is May 4, 2026 (fixed date). Applications must be submitted by end of business on that date.
What research topics are funded?
High-priority tobacco regulatory science addressing Addiction, Behavior, Communications, Health Effects, Product Composition and Design, or Toxicity are supported.
How much funding can I request?
Awards have not specified a fixed cap, but the total program funding is $7 million. Review the NOFO for typical award ranges for your project type.
Are clinical trials required?
No. Clinical trials are optional. Tobacco regulatory science projects without clinical components are welcome.
💡 Tips for applicants
- Align your research directly to FDA's regulatory needs and tobacco control priorities. Vague tobacco research won't be competitive.
- Address all required components within your selected priority topic(s). Partial coverage of a topic is a common rejection reason.
- Demonstrate how your findings will inform FDA tobacco product regulation and protect public health. Connect science to policy impact.
- Work with FDA's Center for Tobacco Products early if possible. Understanding their current regulatory questions strengthens your proposal.
- Budget realistically and justify all costs. NIH reviewers scrutinize budgets for R&D projects closely.
⚠️ Common mistakes
Submitting research that falls outside FDA's tobacco regulatory authority or fails to address all components of the selected priority topics. Unclear connection between research findings and FDA regulatory decision-making. Insufficient preliminary data to support feasibility claims.
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