Grant Details

GRANT OVERVIEW

Grant name and funding organization

High-Priority Research in Tobacco Regulatory Science

National Institutes of Health (NIH)

Total funding amount and duration

Total funding amount: Up to $4 million

Maximum budget per application: $500,000 in direct costs per year

Maximum project period: 5 years

Primary objective and mission statement

To support high-priority biomedical and behavioral research that informs the regulation of tobacco products to protect public health.

Key stakeholders and beneficiaries

U.S. Food and Drug Administration (FDA)

Public health community

Researchers in tobacco regulatory science

ELIGIBILITY CRITERIA

Organization Requirements

Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, and tribal governments.

Nonprofits must have 501(c)(3) status or not.

Foreign organizations and non-domestic entities are eligible to apply.

Geographic Scope

Open to U.S. and foreign organizations.

Project Requirements

Research must address high-priority topics related to FDA's regulatory authority over tobacco products.

Projects must propose high-priority research aims within the regulatory authority of FDA CTP.

Financial Requirements

No cost sharing is required.

Application budgets are limited to $500,000 in direct costs per year.

Timeline Requirements

Application opening date: May 6, 2025

Application deadline: June 6, 2025

Previous Funding Considerations

Applicants may submit more than one application, provided each is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications.

APPLICATION PROCESS

Required documentation and materials

Follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.

Evaluation criteria and scoring system

Applications will be evaluated based on significance, innovation, rigor, feasibility, and expertise.

Review process and timeline

Applications will undergo peer review and be evaluated for scientific and technical merit.

Selection criteria and priorities

Scientific and technical merit of the proposed project will be a key factor in funding decisions.

SPECIAL CONSIDERATIONS

Unique aspects or requirements

Encouragement to incorporate measures from the PhenX Toolkit for data harmonization.

Potential challenges or limitations

Applicants must ensure compliance with all application instructions to avoid delays or rejection.

Strategic alignment opportunities

Research should align with FDA's regulatory priorities.

Competitive advantages or disadvantages

Applications that address high-priority research topics are more likely to be funded.

KEY INSIGHTS AND RECOMMENDATIONS

Critical success factors

Clear alignment with FDA regulatory priorities and high-priority research topics.

Common pitfalls to avoid

Submitting overlapping applications or failing to comply with application instructions.

Strategic recommendations for applicants

Engage with NIH contacts for guidance on application responsiveness.

Competitive positioning advice

Highlight unique aspects of the proposed research that align with public health goals.

Grant Details

tobacco regulation public health biomedical research behavioral research FDA health disparities addiction research tobacco products clinical trials
High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional)
RFA-OD-25-001
NIH Grants
EDU NGO ENTERPRISE PUBLIC OTHER
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RESEARCH_DEVELOPMENT
False
4000000.00
None
500000.00
USD
None
True
False
Research results are expected to inform FDA's regulation of tobacco products, thereby protecting public health.
Scientific data relevant to the regulation of tobacco products.
June 6, 2025, 10 p.m.
October 2025 - January 2026
Follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
True
Applications will be evaluated based on significance, innovation, rigor, feasibility, and expertise.
Applications must demonstrate innovative approaches to high-priority research topics.
Applications must demonstrate a feasible approach to achieving the proposed research aims.
Applications must demonstrate potential for significant impact on public health.
False
False
R01 Research Project Grant
Recipients must comply with all NIH policies and regulations.
Annual progress reports and final reports are required.
Payments will be made according to NIH policies.
All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Research must align with FDA's regulatory priorities.