This Notice of Funding Opportunity (NOFO) supports new investigators in biomedical, behavioral, and social sciences to establish independent careers in tobacco regulatory research. The R03 grant mechanism supports pilot studies, secondary data analysis, small research projects, methodology development, and new research technology. Projects should inform regulations on tobacco product manufacturing, distribution, and marketing, addressing high-priority research topics related to the FDA's regulatory authority.

Purpose and Background

The goal is to provide scientific evidence to inform the implementation of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). This act grants the FDA Center for Tobacco Products (CTP) the authority to regulate tobacco product manufacturing, distribution, and marketing. The awards are administered by NIH using funds from FDA CTP, aiming to generate findings directly relevant to FDA's regulation of tobacco products.

Since 2009, the FDA has regulated various tobacco products, including electronic nicotine delivery systems (ENDS). The FDA also has the authority to develop tobacco product standards for public health protection. This NOFO encourages high-priority research to provide additional scientific data for the FDA to consider as it implements the FSPTCA.

Projects must propose high-priority research aims within the regulatory authority of FDA CTP and address one or more of the High-Priority Research Topics identified in this NOFO. Investigators are strongly encouraged to discuss their application's responsiveness with a Scientific/Research Contact before submitting a Letter of Intent or application.

Funding Details and Key Dates

NIH intends to fund up to 4 R03s, totaling up to $500,000 for fiscal year 2026, with future amounts depending on fund availability. Application budgets are limited to $75,000 in direct costs per year. The maximum project period is 2 years.

The Open Date (Earliest Submission Date) is October 18, 2025. The application due date is November 18, 2025. The Expiration Date is July 15, 2026. A Letter of Intent is due 60 days prior to the application due date.

All applications are due by 5:00 PM local time of the applicant organization. No late applications will be accepted. Applicants are encouraged to apply early to allow time for corrections during the submission process.

Eligibility Criteria

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local, state, and tribal governments, and U.S. territories. Foreign organizations and non-U.S. components of U.S. organizations are not eligible.

• Applicants must have active registrations in SAM, obtain a UEI, and register with eRA Commons and Grants.gov.

• All PD(s)/PI(s) must have an eRA Commons account.

Only New Investigators (including Early-Stage Investigators and those who haven't successfully competed for independent NIH funding) are eligible. Individuals who have received an R01, an FDA CTP R03 or R21, or are in the Research Award Phase of an FDA CTP R00 are excluded.

High-Priority Research Topics

Research must address one or more of the following high-priority topics:

• Understanding the effect of tobacco product characteristics of ENDS and/or nicotine pouches on addiction and/or abuse liability across populations.

• Understanding the knowledge, attitudes, perceptions, and/or behaviors related to use of ENDS, heated tobacco products, nicotine pouches and/or other emerging tobacco products and/or the impact of characteristics of these products on use behaviors of these products across populations, when appropriate to the research question.

• Understanding the health effects of ENDS in human subjects.

• Understanding the chemical and/or microbial constituents in any tobacco products and/or the methods for measuring them across products with diverse characteristics including impacts due to design properties.

• 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.

Projects must propose research aims within the regulatory authority of FDA CTP and the High-Priority Research Topics identified in this NOFO. Non-responsive research topics include investigations of tobacco products other than those explicitly specified in the high-priority research topics of this RFA, studies exploring how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media, studies exploring the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations, studies of the potential or actual impact of FDA regulatory actions, mechanistic studies (i.e., basic science of disease development) unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome, short-term studies of the acute effects of reduced nicotine content cigarettes, studies identifying biomarkers of secondary and tertiary exposure to tobacco products, studies of in-utero exposure to tobacco products and subsequent behavioral effects in offspring, studies using neuroimaging as a biomarker of tobacco product exposure or nicotine dependence, studies identifying epigenetic biomarkers associated with tobacco use including DNA methylation or other non-DNA sequence related mechanisms that regulate gene expression through reversible alterations such as histone modification and noncoding RNA modulation.

Applicants should consider data harmonization using the PhenX Toolkit and be aware of FDA CTP guidance regarding tobacco industry funding.

Application and Submission

Applicants must follow instructions in the Research (R) Instructions in the How to Apply - Application Guide. Conformance to requirements is strictly enforced, and non-compliant applications may be delayed or not accepted. The application forms package must be accessed through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.

A Letter of Intent is requested, including the descriptive title of the proposed activity, PD/PI names and contact information, names of key personnel, participating institutions, and the funding opportunity number and title. The letter should be sent to TRSP@nih.gov.

Applications will be evaluated for completeness, compliance, and responsiveness. Incomplete, non-compliant, or non-responsive applications will not be reviewed. Applicants are requested to notify the Tobacco Regulatory Science Program at TRSP@mail.nih.gov upon submission.