Notice of Intent to Publish a Notice of Funding Opportunity (NOFO) for High-Priority Research in Tobacco Regulatory Science (R01 Clinical Trial Optional)

Key Dates

Related Announcements

None

Issued by

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Purpose

This Notice is to inform the extramural research community that the National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP), 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) seeking R01 research applications for new High-Priority Research in Tobacco Regulatory Science (Clinical Trial Optional).

The NOFO will solicit applications to support new high-priority biomedical and behavioral research that will provide scientific data to inform the regulation of tobacco products to protect public health. This NOFO will include the new simplified peer review framework (SRF) and the Plan for Enhancing Diverse Perspectives.

This Notice is being provided now to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

Only New applications will be eligible. The NOFO will have one application cycle.

The NOFO is expected to be published in Winter 2024, with an expected application due date in Summer 2025.

Details of the planned NOFO are provided below.

The FDA and NIH share an interest in supporting research that could inform FDA's tobacco regulatory authorities. To that end, the research encouraged by the NOFO is expected to provide additional scientific data to the research base to inform regulation of tobacco products to protect public health. Although a vast and sound science base exists with regard to numerous areas related to the Family Smoking Prevention and Tobacco Control Act (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.

Research projects must address the research priorities related to the regulatory authority of the FDA CTP- as mandated by the FSPTCA. The awards under the NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA.

The NOFO will solicit research applications that only address one or more of the below high-priority research topics. Tobacco-related health disparities, as appropriate to the high-priority research topics below, may be considered a cross-cutting theme.

HIGH-PRIORITY RESEARCH TOPICS

High-Priority Research Relevant to Addiction - Understanding the effect of tobacco product characteristics* of electronic nicotine delivery systems (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:

• Correlation of nicotine pharmacokinetic and/or pharmacodynamics (and/or other abuse liability outcomes including liking, craving, and withdrawal symptoms) of ENDS and/or nicotine pouches with use behaviors, including cessation or substitution of combusted cigarettes
• Impact of changes in tobacco product characteristics* of ENDS and/or nicotine pouches on dependence and/or use behaviors including progression to regular use

High-Priority Research Relevant to Behavior - 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. Applications addressing behavior must address the high-priority research topic below:

• The impact of ENDS, heated tobacco products, nicotine pouches and/or other emerging tobacco products characteristics* on tobacco product use behaviors (such as experimentation, initiation, progression, dual/poly tobacco use, switching, and/or cessation-related behaviors) among youth, young adults, and/or adults

High-Priority Research Relevant to Health Effects - 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 in animal models)

High-Priority Research Relevant to Product Composition and Design - Understanding the chemical and/or microbial constituents in any tobacco product and/or the methods for measuring them across products with diverse characteristics*, including impacts due to design properties. Applications addressing product composition and design must address one or more of the high-priority research topics below:

• Determination of levels of characterizing flavors and/or the complexity of the individual ingredients on the sensory perception of such flavors in tobacco products, including cooling ingredients and/or other understudied ingredients
• Evaluation of the chemical, behavioral, and/or pharmacokinetic differences between products containing synthetic nicotine compared to products containing tobacco or nicotine derived from tobacco

High-Priority Research Relevant to Toxicity - 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) in ENDS. Applications addressing toxicity must (1) focus on ENDS and/or their characteristics* AND (2) address one or more of the high-priority research topics below:

• Toxicological hazard analysis (i.e., cytotoxicity, genotoxicity, mutagenicity, organ toxicity) of flavor ingredient use in ENDS and/or constituents formed during ENDS use
• Dose response of individual flavor ingredients used in ENDS and constituents formed during ENDS use and their potential interaction with metals
• Toxicological interactions (i.e., additive, synergistic, antagonistic) between aldehydes found in ENDS aerosols and comparison of their combined effects to their individual effects, including dose response

*The term characteristic encompasses materials, ingredients (including additives, nicotine formulations, nicotine concentration, and flavors), design, composition, heating source, nicotine flux, and other features of a tobacco product, including harmful and potentially harmful constituents. Packaging is not included in this definition of characteristic. Characteristics of explicitly specified tobacco products can be incorporated into all of the above High-Priority Research Topics.

Non-Responsive Research Topics

Only high-priority research topics listed above will be deemed responsive. Although the following research topics may be within FDA CTP’s regulatory authorities, they will not be included in the NOFO and will be deemed non-responsive:

• Investigations of tobacco products other than those explicitly specified in the high-priority research areas;
• 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;
• Studies of short-term health effects and/or acute topography/clinical pharmacology testing of early generation ENDS products;
• 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.

Funding Information

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Tobacco Regulatory Science Program (TRSP)
Office of Disease Prevention (ODP)
Telephone: 301-451-7464
Email: [email protected]