This is a critical question, as each of the specific aims in the application must meet the following criteria to be considered responsive. The project must:

• Address one or more of the High-Priority Research Topics listed in the NOFO
• Fall within the scope of FDA CTP’s regulatory authority

As such, applicants are strongly encouraged to contact the Scientific/Research Contact(s) listed in the NOFO for feedback about responsiveness prior to submitting an application. Sharing your research ideas and specific aims, and submitting a letter of intent prior to applying, will allow NIH staff to provide responsiveness feedback.

If your application is deemed responsive, it will undergo scientific peer review by experts convened specifically for that purpose (by the NIH Center for Scientific Review). If your application is deemed nonresponsive, it will be withdrawn prior to evaluation of its scientific merit (i.e., peer review). Program officials will let you know if the application must be withdrawn from peer review.

This NOFO has one application due date of June 6, 2025; the NOFO will expire on June 7, 2025. 

Currently there are no other open Tobacco Regulatory Science Program (TRSP) NOFOs to submit tobacco regulatory science focused proposals. We suggest you contact the program officials at the NIH institutes and centers (ICs) who are named in the RFA to determine the fit for your proposal within their current mission and priorities. They may also suggest you speak with other program officials at nonparticipating ICs.

An LOI is not required and it is not part of the peer review process. However, it allows NIH staff to estimate the potential review workload and plan the review. Investigators are encouraged to send their specific aims with their LOI so that NIH Scientific/Research Contact(s) can review their research ideas and aims before they submit applications, as all proposed specific aims must be within the regulatory authority of FDA CTP and clearly address one or more of the NOFO’s High-Priority Research Topics in order to be deemed responsive. Applications that are nonresponsive will not be reviewed. To ensure timely feedback on the responsiveness of specific aims, please submit LOIs no later than April 7, 2025.

Suggested content of LOI:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the Program Director(s)/Principal Investigator(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
• Specific aims

The letter may be sent by email to: [email protected]

Only the High-Priority Research Topics listed in the NOFO will be deemed responsive. Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they are not to be included in the NOFO and will be deemed nonresponsive: 

• Investigations of tobacco products other than those explicitly specified in the High-Priority Research Topics
• 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 included as 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

For example, is a proposed longitudinal study focusing on perceptions of, use behavior of, and dependence on heated tobacco products responsive to this RFA even though heated tobacco products are not listed as a product of interest in the addiction research topic? 

If the study of heated-tobacco-product dependence is related to the use behaviors of the product, then the proposal may be considered responsive under the High-Priority Research Topic relevant to behavior. The proposal may be considered nonresponsive if it were seeking to respond to the High-Priority Research Topics relevant to addiction for any product other than electronic nicotine delivery systems (ENDS) and/or nicotine pouches. As the determination of responsiveness will be dependent on the details of the proposal, we strongly recommend discussing your specific aims with the Scientific/Research Contact(s) listed in the RFA prior to application submission. 

No, cancer in human subjects is not responsive to this RFA. This High-Priority Research Topic is seeking to understand the noncancerous pulmonary effects of ENDS.

No. A study with cannabis/marijuana as one of the primary outcomes is not responsive because FDA CTP does not regulate cannabis/marijuana under its tobacco product authorities. However, research designed to evaluate the extent to which cannabis/marijuana is used within tobacco products (e.g., within nicotine-containing e-cigarettes, blunts), as a means to more accurately characterize or assess tobacco product use behavior, could be responsive to FDA CTP authorities.

No. Studies proposing to focus on products (e.g., disposable vapes or oral pouches) containing nicotine analogs and no nicotine nor tobacco-derived constituents are not responsive to this RFA. Studies that analyze products for the presence or absence of 6-methyl nicotine, for example, when characterizing product composition may be responsive. However, such proposed research should be confirmed for responsiveness by the Scientific/Research Contact(s) listed in the RFA prior to application submission.

Potentially, yes. If the product(s) meets the statutory definition of a “tobacco product” under the Tobacco Control Act (i.e., any product made or derived from tobacco or containing nicotine from any source that is intended for human consumption, including any component, part, or accessory of a tobacco product), then studies examining these products could be considered responsive if they address one or more of this NOFO’s High-Priority Research Topics. However, the application must demonstrate that the proposed research can directly contribute to FDA CTP’s regulatory authority over the manufacture, marketing, and distribution of tobacco products within the United States.

Foreign populations may be included. However, results from research in foreign populations must be relevant to the U.S. population and U.S. regulation of tobacco products. For example, studies assessing health effects related to tobacco product use would be relevant to the extent that the findings could be generalized to the United States. Studies assessing general knowledge or attitudes about tobacco products among foreign populations would not likely be relevant.

As specified in the RFA, where appropriate to the research question, applications may focus on populations or groups that bear disproportionate burden of tobacco product risk and harm. If a population experiencing tobacco-related disparities will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health.