FAQs: High-Priority Research Topics R03 in Tobacco Regulatory Science

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

• Address one or more of the bulleted subtopics under the High-Priority Research Topics listed in the NOFO.
  • Fall within the scope of FDA CTP’s regulatory authority.
  • Avoid addressing the non-responsive research topics listed in the NOFO.

As such, you are strongly encouraged to contact the NIH Scientific/Research Contact(s) listed in the NOFO for feedback about responsiveness before submitting an application. Submitting your proposed research as a specific aims page with a request to initiate a Pre-Application Consultation before 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 this NOFO by the NIH Center for Scientific Review. If your application is deemed non-responsive, it will be withdrawn before the evaluation of its scientific merit (i.e., peer review). Program officials will notify you if the application must be withdrawn before peer review.

This NOFO has two application due dates: November 18, 2025 (extended to December 5, 2025 due to the government shutdown) and July 14, 2026. The NOFO will expire on July 15, 2026.

We suggest you contact the program officials at the NIH Institutes and Centers (ICs) named in the NOFO to identify other NOFOs that may be a fit for your proposed research. They may also suggest that you speak with other program officials at nonparticipating ICs.

NI status is only applicable if you have not yet successfully competed for a substantial NIH independent research award. For a list of awards excluded from consideration as “independent research,” see the NIH definition of New Investigators. Although PD/PIs of an NIH R03, R21, or R00 are generally considered to have NI status, note that this NOFO also excludes from consideration individuals who have received any award through the Tobacco Regulatory Science Program (TRSP). This includes, but is not limited to, recipients supported through the following NOFOs: 

• Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 – Independent Clinical Trial Not Allowed)
• Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 – Independent Clinical Trial Required)
• Research Award Phase (R00) of a Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 – Independent Clinical Trial Not Allowed)
• Research Award Phase (R00) of a Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 – Independent Clinical Trial Required)
• Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)
• Tobacco Regulatory Science Exploratory/Developmental Research Grant (R21)

Investigators who have questions about eligibility should contact the NIH Scientific/Research Contact(s) listed in Section VII. Agency Contacts of the NOFO.

Yes. The NI status for an application is initially based on the investigator’s status on the date the application is successfully submitted to the NIH. However, NI status will be reassessed for any other pending application after peer review and before consideration for award. A PI will lose NI status immediately upon receipt of any substantial NIH research grant. As such, receipt of an R01 before the Notice of Award for this NOFO would make you ineligible.

Yes. Investigators who have been an independent PD/PI on a Small Research Grant Program (R03) are not eligible to apply for a Pathway to Independence Award (K99/R00).

Yes, you can see whether you are currently designated as an NI in your eRA Commons account. NI status is determined automatically by the functionality built into eRA Commons, based on the investigator’s record of receiving NIH grants. For instructions on creating an eRA Commons Account, which is required before submitting an application, see Create and Manage an eRA Commons Account on the NIH eRA website. However, in addition to this automatically determined designation as an NI, your eligibility for this NOFO is affected by whether you have received a prior CTP-funded award. Please refer to the first eligibility-related FAQ question above for additional information.

The first step to ensure you are correctly designated as a New or Early Stage Investigator is to log into your eRA Commons account and confirm that your Personal Profile indicates that you are an NI. If you believe that your designation does not reflect your current NI status, you can “Submit a Web Ticket” to the eRA Service Desk to request a correction of your NI status for the submitted application.

No, this is an independent research award.

No, foreign institutions are not eligible to apply for this NOFO.

The intent of this NOFO is to develop a cadre of NIs in the early stages of establishing independent careers in tobacco regulatory research. There are no citizenship requirements to apply, but investigators must demonstrate that the proposed research can directly contribute to the FDA CTP’s regulatory authority over tobacco products manufactured, sold, and/or distributed in the United States and one or more of the High-Priority Research Topic(s) listed in the NOFO. Individuals must also demonstrate that they will be employed by an eligible institution for the full award period of the grant.

Yes. R03 budgets submitted to this NOFO are limited to $75,000 in direct costs per year. Applications with budgets exceeding this cap will not be considered.

No. A Pre-Application Consultation is not required, nor is it a part of the peer review process. However, you are encouraged to submit a specific aims page so that NIH Scientific/Research Contact(s) can review your proposed research before you submit an application. Proposed research must be within the regulatory authority of FDA CTP and clearly address at least one bulleted subtopic under a High-Priority Research Topic in the NOFO to avoid being non-responsive. Non-responsive applications will not advance to peer review. To ensure timely feedback on the responsiveness of specific aims, please initiate a Pre-Application Consultation 60 days prior to the application due date.

Suggested content of an email to initiate a Pre-Application Consultation:

• Number and title of this funding opportunity
• Descriptive title of proposed activity
• Name(s) of the Program Director(s)/Principal Investigator(s)
• Participating institution(s)
• Specific aims page

You can initiate a Pre-Application Consultation by emailing a specific aims page to: [email protected]. See the FAQ above for suggested email content.

Please review the Non-Responsive Research Topics subsection under Section I of this NOFO for topics that are non-responsive to this NOFO.

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

If the study of heated tobacco product dependence relates to the use behaviors of the product, then the application may be considered responsive under the High-Priority Research Topic relevant to behavior. However, the application may be considered non-responsive if it seeks to respond to the High-Priority Research Topic relevant to addiction for any product other than electronic nicotine delivery systems (ENDS) and/or nicotine pouches. Because responsiveness will depend on the details of the application, we strongly recommend discussing your specific aims with the NIH Scientific/Research Contact(s) listed in the NOFO before submitting an application.

No, cancer in humans is non-responsive to this NOFO. The health effects research topic seeks to understand the non-cancerous pulmonary effects of ENDS. As stated in the NOFO, research on the impact of ENDS use on human health is limited to cardiovascular, pulmonary, or neurological effects, including acute and/or chronic health outcomes in humans (i.e., not animal models).

No, cognitive function is not responsive to this NOFO. However, examples of outcomes that would be responsive to the neurological effects of ENDS may include stroke, seizures, or other acute and/or chronic health outcomes in humans.

For some High-Priority Research Topics, applications are limited to proposed research in humans (i.e., human subjects and de-identified human data).

No. A study examining cannabis/marijuana perceptions, addiction, and/or use as one or more of the primary outcomes is non-responsive because FDA CTP’s regulatory authority does not include cannabis/marijuana. However, research designed to evaluate the extent to which cannabis/marijuana is used within tobacco products (e.g., within nicotine-containing e-cigarettes or blunts) to accurately characterize or assess the tobacco product could be responsive to FDA CTP regulatory authorities. Additionally, research assessing cannabis/marijuana for the purposes of ruling out, controlling for, or screening for its use to more precisely evaluate a tobacco product could be responsive to FDA CTP’s regulatory authority. You should confirm that your proposed research is responsive by contacting the NIH Scientific/Research Contact(s) listed in the NOFO before submitting an application.

No. Studies proposing to focus on products that do not contain nicotine or tobacco-derived constituents but instead contain nicotine analogs (e.g., 6-methyl nicotine) are non-responsive to this NOFO. However, studies that analyze tobacco products (i.e., those containing nicotine or tobacco-derived constituents) for the presence or absence of nicotine analogs when characterizing product composition may be responsive. Because responsiveness will depend on the details of the application, we strongly recommend that you discuss your specific aims with the NIH Scientific/Research Contact(s) listed in the NOFO before submitting an application.

No. The use of VR-CPP to assess tobacco product use behaviors is non-responsive to this NOFO. This NOFO seeks research that will assess actual behaviors, such as whether participants experimented with, initiated, progressed to, dual/poly used, switched, or quit tobacco products. The use of VR-CPP would be considered a potential measure of intentions to use a tobacco product rather than an actual measure of tobacco product use behavior.

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 the High-Priority Research Topics in this NOFO. However, the application must demonstrate that the proposed research can directly contribute to the regulatory authority of FDA CTP over tobacco products sold and distributed in the United States. Note that some of the High-Priority Research Topics in this NOFO specify the type(s) of tobacco products to be studied and that the Non-Responsive Research Topics list in this NOFO includes investigations of tobacco products other than those explicitly specified in the high-priority research topics of this RFA. Consequently, the application must only address the type(s) of tobacco products listed for the High-Priority Research Topic(s) the proposed research plans to address.

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

In the NIH notice (NOT-OD-25-104) published on May 1, 2025, foreign subawards are no longer allowed. However, the Notice states that although this policy applies to all monetary foreign collaborations, “it does not apply to funds provided to support foreign consultants.” For the definition of a consultant, please see the NIH Grants Policy Statement. If a foreign collaborator is included, then a Foreign Justification must be provided in the application (NOT-OD-25-098).

Yes, studies in populations experiencing tobacco-related disparities are responsive to FDA CTP regulatory authorities. However, the population must be appropriate for the research question. For studies focused on a specific population experiencing tobacco-related disparities, applicants will be expected to explain why and how this population is important to the research question, considering the impact on population health.

Yes. You may resubmit an application by the second (i.e., final) submission date for this NOFO. It is highly recommended that you address all issues and concerns raised in the peer review summary statement.