None
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
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:
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:
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:
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:
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:
*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 CTPs regulatory authorities, they will not be included in the NOFO and will be deemed non-responsive:
NIH, via support from the FDA Center for Tobacco Products (CTP), intends to fund up to 5 R01s, corresponding to a total of up to $4 million, for fiscal year 2026. Future year amounts will depend on the availability of funds.
5
Application budgets are limited to $500,000 in direct costs per year for up to five years.
93.077
Applications are not being solicited at this time.
Please direct all inquiries to:
Tobacco Regulatory Science Program (TRSP)
Office of Disease Prevention (ODP)
Telephone: 301-451-7464
Email: TRSP@nih.gov